,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342837,Effect of Mass Treatment with Azithromycin on Causes of Death in Children in Malawi: Secondary Analysis from the MORDOR Trial.,"Recent evidence indicates mass drug administration with azithromycin may reduce child mortality. This study uses verbal autopsy (VA) to investigate the causes of individual deaths during the Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial in Malawi. Cluster randomization was performed as part of MORDOR. Biannual household visits were conducted to distribute azithromycin or placebo to children aged 1-59 months and update the census to identify deaths for VA. MORDOR was not powered to investigate mortality effects at individual sites, but the available evidence is presented here for hypothesis generation regarding the mechanism through which azithromycin may reduce child mortality. Automated VA analysis was performed to infer the likely cause of death using two major analysis programs, InterVA and SmartVA. A total of 334 communities were randomized to azithromycin or placebo, with more than 130,000 person-years of follow-up. During the study, there were 1,184 deaths, of which 1,131 were followed up with VA. Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20). The intention-to-treat analysis by cause using InterVA suggested fewer HIV/AIDS deaths in azithromycin-treated communities (rate ratio 0.70 [95% CI: 0.50-0.97];  P  = 0.03) and fewer pneumonia deaths (rate ratio 0.82 [95% CI: 0.60-1.12];  P  = 0.22). The use of the SmartVA algorithm suggested fewer diarrhea deaths (rate ratio 0.71 [95% CI: 0.51-1.00];  P  = 0.05) and fewer pneumonia deaths (rate ratio 0.58 [95% CI: 0.33-1.00];  P  = 0.05). Although this study is not able to provide strong evidence, the data suggest that the mortality reduction during MORDOR in Malawi may have been due to effects on pneumonia and diarrhea or HIV/AIDS mortality.",2020,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"['A total of 334 communities', 'Children in Malawi']","['azithromycin', 'Azithromycin', 'azithromycin or placebo']","['child mortality', 'pneumonia deaths', 'Causes of Death', 'Mortality', 'diarrhea deaths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",334.0,0.538584,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0613']
1,32342840,Cost-Effectiveness of Mass Treatment with Azithromycin for Reducing Child Mortality in Malawi: Secondary Analysis from the MORDOR Trial.,"The recent Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin mass drug administration (MDA). Here, we investigate the financial costs and cost-effectiveness from the health provider perspective of azithromycin MDA at the MORDOR-Malawi study site. During MORDOR, a cluster-randomized trial involving biannual azithromycin MDA or placebo to children aged 1-59 months, fieldwork-related costs were collected, including personnel, transport, consumables, overheads, training, and supervision. Mortality rates in azithromycin- and placebo-treated clusters were calculated overall and for the five health zones of Mangochi district. These were used to estimate the number needed to treat to avert one death and the costs per death and disability-adjusted life year (DALY) averted. The cost per dose of MDA was $0.74 overall, varying between $0.63 and $0.94 in the five zones. Overall, the number needed to treat to avert one death was 1,213 children; the cost per death averted was $898.47, and the cost per DALY averted was $9.98. In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows: 3,070, $2,899.24, and $32.31 in Monkey Bay zone; 1,530, $1,214.42, and $13.49 in Chilipa zone; and 344, $217.98, and $2.42 in Namwera zone. This study is a preliminary cost-effectiveness analysis that indicates azithromycin MDA for reducing child mortality has the potential to be highly cost-effective in some settings in Malawi, but the reasons for geographical variation in effectiveness require further investigation.",2020,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:",['Malawi'],"['biannual azithromycin MDA or placebo', 'azithromycin- and placebo', 'Azithromycin', 'azithromycin MDA', 'azithromycin']","['cost per death averted', 'child mortality', 'cost per dose of MDA', 'Child Mortality', 'financial costs and cost-effectiveness', 'mortality', 'Mortality rates']","[{'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0794041,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0622']
2,32342841,Effects of Biannual Azithromycin Mass Drug Administration on Malaria in Malawian Children: A Cluster-Randomized Trial.,"Reductions in malaria morbidity have been reported following azithromycin mass drug administration (MDA) for trachoma. The recent Macrolides Oraux pour Reduire les Deces avec un Oeil sur la Resistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin MDA. Here, we investigate the effects of azithromycin MDA on malaria at the MORDOR-Malawi study site. A cluster-randomized double-blind placebo-controlled trial, with 15 clusters per arm, was conducted. House-to-house census was updated biannually, and azithromycin or placebo syrup was distributed to children aged 1-59 months for a total of four biannual distributions. At baseline, 12-month, and 24-month follow-up visits, a random sample of 1,200 children was assessed for malaria with thick and thin blood smears and hemoglobin measurement. In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities; 95% CI: -2.8 to 1.5), or anemia (1.7% lower in azithromycin-treated communities; 95% CI: -8.1 to 4.6) between placebo and azithromycin communities. Further interrogation of the data at the individual level, both per-protocol (including only those who received treatment 6 months previously) and by intention-to-treat, did not identify differences in parasitemia between treatment arms. In contrast to several previous reports, this study did not show an effect of azithromycin MDA on malaria parasitemia at the community or individual levels.",2020,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities",['Malaria in Malawian Children'],"['azithromycin or placebo syrup', 'azithromycin MDA', 'azithromycin', 'Biannual Azithromycin Mass Drug Administration', 'azithromycin-treated communities', 'placebo']","['child mortality', 'malaria parasitemia', 'anemia', 'prevalence of parasitemia', 'gametocytemia', 'malaria morbidity', 'malaria with thick and thin blood smears and hemoglobin measurement']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",1200.0,0.469202,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Lyson', 'Initials': 'L', 'LastName': 'Samikwa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Feston', 'Initials': 'F', 'LastName': 'Sikina', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Burr', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0619']
3,32343001,Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.,"BACKGROUND


Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD.
AIMS


To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants.
METHODS


Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation.
RESULTS


Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m 2  ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05).
CONCLUSIONS


Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).",2020,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","['Participants underwent 48\xa0h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively', 'Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5\xa0years, males 77.8% and BMI 32.8\xa0kg/m 2  ', 'obese individuals after late-night supper', 'obese participants', 'obese patients with GERD']","['Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid', 'antacid', 'Gaviscon Advance', 'Gaviscon Advance vs antacid', 'Gaviscon Advance vs non-alginate antacid', 'Gaviscon Advance or a non-alginate antacid']","['suppression of % time pH', 'Median pH of the acid pocket', 'symptom frequency and VAS', 'frequency and visual analogue score (VAS) of regurgitation', 'suppression of median pH of acid pocket and lower oesophagus']","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}]",81.0,0.0540182,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","[{'ForeName': 'Mohd Adli', 'Initials': 'MA', 'LastName': 'Deraman', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Muhammad Ilham', 'Initials': 'MI', 'LastName': 'Abdul Hafidz', 'Affiliation': 'Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh, Malaysia.'}, {'ForeName': 'Rona Marie', 'Initials': 'RM', 'LastName': 'Lawenko', 'Affiliation': 'De La Salle Health Sciences Institute, Dasmarinas, Philippines.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15746']
4,32338931,Theory-specific patient change processes and mechanisms in different cognitive therapies for depression.,"OBJECTIVE


This study aimed to identify differential patient change processes and mechanisms associated with long-term outcome in exposure-based cognitive therapy (EBCT) and cognitive-behavioral therapy (CBT) for depression.
METHOD


We drew on a randomized controlled trial in which 149 patients were randomly assigned to either EBCT or CBT, with the treatments showing comparable efficacy at 12-month follow-up (grosse Holtforth et al., 2019). Based on Doss's (2004) 4-step model of psychotherapy change and using sequential multilevel structural equation models, we tested putative theory-based change processes and mechanisms for both treatments. Specifically, we examined emotional processing and cognitive restructuring during treatment as hypothesized change processes of EBCT and CBT, respectively. Furthermore, as potential change mechanisms during follow-up, we examined theory-relevant mechanisms for each treatment, preselected via multilevel models.
RESULTS


Although the full serial mediational pathways were not supported, EBCT fostered greater during-treatment increases in emotional processing and higher self-efficacy during follow-up than CBT, both of which associated with better long-term depression outcome. Unexpectedly, cognitive restructuring change did not differ between EBCT and CBT. Across both CBT and EBCT, greater during-treatment increases in cognitive restructuring related to lower cognitive-behavioral avoidance and greater self-efficacy across follow-up, which associated with lower long-term depression.
CONCLUSIONS


Results suggest that therapists might improve long-term depression outcome by fostering both emotional processing (via emotion-focused techniques as included in EBCT) and cognitive restructuring (by using general CBT techniques included in both treatments), which operate either directly or through varied treatment-common mechanisms (e.g., greater self-efficacy and reduced cognitive-behavioral avoidance). (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Although the full serial mediational pathways were not supported, EBCT fostered greater during-treatment increases in emotional processing and higher self-efficacy during follow-up than CBT, both of which associated with better long-term depression outcome.",['149 patients'],"['EBCT or CBT', 'exposure-based cognitive therapy (EBCT) and cognitive-behavioral therapy (CBT']","['cognitive-behavioral avoidance and greater self-efficacy', 'cognitive restructuring change', 'emotional processing and higher self-efficacy']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205250', 'cui_str': 'High'}]",149.0,0.0333601,"Although the full serial mediational pathways were not supported, EBCT fostered greater during-treatment increases in emotional processing and higher self-efficacy during follow-up than CBT, both of which associated with better long-term depression outcome.","[{'ForeName': 'Juan Martín', 'Initials': 'JM', 'LastName': 'Gómez Penedo', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}, {'ForeName': 'Adele M', 'Initials': 'AM', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000502']
5,32338932,Predictors and moderators of treatment outcome in a randomized clinical trial for binge-eating disorder.,"OBJECTIVE


The current study examined predictors and moderators of two interventions for binge-eating disorder (BED).
METHOD


Participants were 112 adults with BED ( M age  = 39.7 ± 13.4 years;  M BMI  = 35.1 ± 13.4 kg/m²; 82% female; 91% Caucasian) randomly assigned to integrative cognitive-affective therapy for BED (ICAT-BED) or guided self-help cognitive-behavioral therapy (CBTgsh). Generalized linear models examined predictors and moderators of objective binge-eating episode (OBE) frequency and OBE abstinence at end-of-treatment (EOT) and 6-month follow-up (FU).
RESULTS


Lower levels of baseline dietary restraint and emotion regulation difficulties predicted greater reductions in OBE frequency at EOT and FU, respectively. At EOT, greater pretreatment self-control predicted greater reductions in OBE frequency in ICAT-BED than CBTgsh ( p s < .05). In addition, low shape/weight overvaluation predicted greater reductions in OBE frequency in ICAT-BED than CBTgsh, whereas high shape/weight overvaluation predicted comparable reductions in OBE frequency across treatments at EOT ( p s < .02). At EOT and FU, greater baseline actual-ideal self-discrepancy predicted significantly greater reductions in OBE frequency in ICAT-BED, than CBTgsh ( p s < .02). No significant predictor or moderator effects were observed for models examining OBE abstinence.
CONCLUSION


This study identified two general predictors and four moderators of BED treatment response. However, only one predictor (actual-ideal self-discrepancy) interacted with treatment type to differentially predict OBE frequencies at both EOT and FU. Altogether, findings suggest that ICAT-BED may confer specific and durable improvements in OBE frequencies among individuals with high actual-ideal self-discrepancy. Therefore, patients demonstrating these characteristics may be more likely to benefit from ICAT-BED. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Lower levels of baseline dietary restraint and emotion regulation difficulties predicted greater reductions in OBE frequency at EOT and FU, respectively.","['Participants were 112 adults with BED ( M age  = 39.7 ± 13.4 years;  M BMI  = 35.1 ± 13.4 kg/m²; 82% female; 91% Caucasian', 'binge-eating disorder (BED']","['integrative cognitive-affective therapy for BED (ICAT-BED) or guided self-help cognitive-behavioral therapy (CBTgsh', 'ICAT-BED', 'treatment (EOT) and 6-month follow-up (FU']","['objective binge-eating episode (OBE) frequency and OBE abstinence', 'OBE frequencies', 'binge-eating disorder', 'OBE frequency']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C2733435', 'cui_str': 'Guided self-help cognitive behavioral therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]",112.0,0.0252791,"RESULTS


Lower levels of baseline dietary restraint and emotion regulation difficulties predicted greater reductions in OBE frequency at EOT and FU, respectively.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and The Behavioral Sciences, University of Southern California.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schaefer', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Sanford Center for Biobehavioral Research.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000503']
6,32338944,Using intraindividual variability as an indicator of cognitive improvement in a physical exercise intervention of older women with mild cognitive impairment.,"OBJECTIVES


Intervention programs designed to improve cognitive ability in older adults with mild cognitive impairment (MCI) have often focused on physical exercise as a means to improve traditional measures of cognition, with mixed success. Individuals with MCI show high levels of intraindividual variability (IIV) in response speed, and IIV may be sensitive to intervention-related changes. The current study evaluated if participants who participated in a physical activity intervention (aerobic or resistance training) showed a reduction in IIV, compared to a balance and tone control group.
METHOD


This study was a secondary analysis of the EXercise for Cognition and Everyday Living (EXCEL) Study. Women Aged 70-80 years with probable MCI ( n  = 86) participated in a 6-month randomized controlled trial designed to investigate the effects of different physical exercises on cognitive ability. Participants completed 1-back, task switching, and spatial working memory tasks at baseline, 13 weeks (midpoint) and upon completion of the program.
RESULTS


Analyses were conducted following both the intent-to-treat principle and complier average casual effect (CACE) modeling. Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models. The intent-to-treat analyses were all nonsignificant.
CONCLUSIONS


Physical exercise resulted in improved IIV in older adults with probable MCI, showing that IIV is modifiable by lifestyle engagement. IIV may be a useful complementary index of cognitive plasticity particularly among those with cognitive impairment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models.,"['Women Aged 70-80 years with probable MCI ( n  = 86', 'older women with mild cognitive impairment', 'older adults with probable MCI', 'older adults with mild cognitive impairment (MCI', 'participants who participated in a']","['physical exercise intervention', 'physical activity intervention (aerobic or resistance training', 'Physical exercise', 'physical exercises', 'balance and tone control group']","['reduced IIV on task switching', '1-back, task switching, and spatial working memory tasks', 'cognitive ability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0449234,Participants in the intervention group who complied with the program showed reduced IIV on task switching in the CACE models.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy.'}, {'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies.'}]",Neuropsychology,['10.1037/neu0000638']
7,32339504,Long-Term Graft Patency After Off-Pump and On-Pump Coronary Artery Bypass: A CORONARY Trial Cohort.,"BACKGROUND


Randomized controlled trials have compared the early and midterm prognosis of on-pump coronary artery bypass grafting (CABG) and off-pump CABG. However the results are controversial, and there is limited information on graft patency and long-term outcomes.
METHODS


Between May 2007 and October 2011, 349 patients were randomized to off-pump or on-pump CABG as part of the CORONARY trial at Fuwai Hospital. The primary outcome was coronary bypass graft patency, which was assessed at a mean of 6.7 ± 1.7 years after surgery by multidetector computed tomography. A secondary endpoint was a composite outcome of death, nonfatal myocardial infarction, repeat coronary revascularization, or stroke; mean follow-up was 6.5 ± 1.7 years. Graft patency was compared between the off-pump and on-pump CABG treatment arms in 206 patients with follow-up computed tomography.
RESULTS


During the follow-up period 107 patients were in the off-pump CABG group and 99 in the on-pump group. These patients underwent a total of 723 grafts, and the overall rate of graft patency did not differ significantly between the off-pump and on-pump groups (87.4% vs 88.9%, P = .527). The patency rate of the posterior descending branch was lower than average. Higher incidences of mortality, nonfatal myocardial infarction, and repeat revascularization were found in the off-pump patients; however it did not reach significance.
CONCLUSIONS


There were no statistical differences in graft patency rates in off-pump versus on-pump CABG patients during long-term follow-up. The on-pump CABG group appeared to have a better long-term prognosis even with no statistical differences for the limited study population.",2020,On-pump CABG group appeared to offer a better long-term prognosis even with no statistical differences for the limited study population.,"['Betweeen', '107 patients in the off-pump CABG group and 99 in the on-pump group during the follow-up period', '206 patients with follow-up computed tomography', 'May 2007 and October 2011, 349 patients']","['pump or on-pump CABG', 'pump coronary artery bypass grafting (CABG) and off-pump CABG', 'Pump and On-Pump Coronary Artery Bypass']","['mortality, nonfatal myocardial infarction and repeat revascularization', 'coronary bypass graft patency', 'graft patency rates', 'patency rate of the posterior descending branch', 'overall rate of graft patency', 'composite outcome of death, nonfatal myocardial infarction, repeat coronary revascularization, or stroke; mean follow-up', 'Graft patency']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",349.0,0.140282,On-pump CABG group appeared to offer a better long-term prognosis even with no statistical differences for the limited study population.,"[{'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Sipeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. Electronic address: zhengzhe@fuwai.com.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.053']
8,32349117,One-day tropisetron treatment improves cognitive deficits and P50 inhibition deficits in schizophrenia.,"The core features of schizophrenia (SCZ) include cognitive deficits and impaired sensory gating represented by P50 inhibition deficits, which appear to be related to the α7 nicotinic acetylcholine receptor (nAChR). An agonist of nAChR receptor may improve these defects. This study aimed to investigate how administering multiple doses of tropisetron, a partial agonist of nAChR, for 1 day would affect cognitive deficits and P50 inhibition deficits in SCZ patients. We randomized 40 SCZ non-smokers into a double-blind clinical trial with four groups: placebo, 5 mg/d, 10 mg/d, and 20 mg/d of oral tropisetron. Their P50 ratios were all more than 0.5 and they took risperidone at 3-6 mg/day for at least a month before participating in the experiment. We measured the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and P50 inhibition before and one day after treatment. After one day of treatment, the total RBANS scores of the 20 mg and 5 mg tropisetron groups, and the immediate memory of the 10 mg group were significantly higher than placebo group. The P50 ratio was smaller in the 5 mg and 10 mg groups than in the placebo group (both p < 0.05) after treatment. Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude. One day of treatment with tropisetron improved both cognitive and P50 inhibition deficits, suggesting that longer term treatment with α7 nAChR agonists for these deficits in SCZ may be promising.",2020,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","['schizophrenia', 'SCZ patients']","['tropisetron', 'risperidone', 'oral tropisetron', 'placebo']","['S1 latency', 'P50 ratio', 'total RBANS scores', 'cognitive and P50 inhibition deficits', 'immediate memory score', 'P50 ratios', 'Neuropsychological Status (RBANS) and P50 inhibition', 'cognitive deficits and P50 inhibition deficits', 'RBANS total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2959617', 'cui_str': 'Repeatable battery for the assessment of neuropsychological status score'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",40.0,0.0632082,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Gaoxia', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiesi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hanjing E', 'Initials': 'HE', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China. zhangxy@psych.ac.cn.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0685-0']
9,32352222,Cluster-randomized crossover trial of chlorhexidine-alcohol versus iodine-alcohol for prevention of surgical-site infection (SKINFECT trial).,,2020,,[],['chlorhexidine-alcohol versus iodine-alcohol'],[],[],"[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}]",[],,0.0806753,,"[{'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Aho Glélé', 'Affiliation': 'Epidemiology and Infection Control Department, 21000, Dijon, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ortega-Deballon', 'Affiliation': 'Digestive Surgery Department, Dijon University Hospital, 14\xa0Rue Paul Gaffarel, 21000, Dijon, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guilloteau', 'Affiliation': 'Epidemiology and Infection Control Department, 21000, Dijon, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Keita-Perse', 'Affiliation': 'Epidemiology and Infection Control Department, Monaco Hospital, Monaco.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Astruc', 'Affiliation': 'Epidemiology and Infection Control Department, 21000, Dijon, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lepelletier', 'Affiliation': 'Epidemiology and Infection Control Department, Nantes University Hospital, Nantes, France.'}]",BJS open,['10.1002/bjs5.50285']
10,32346804,Feasibility of using a computer-assisted working memory training program for healthy older women.,"Interventions for age-associated cognitive impairment are of increasing significance as populations age. Using N-back and memory strategy enhancement, the present study aimed to explore the feasibility of using, and outcomes of a working memory (WM) training program on visuospatial and verbal WM in older female adults. Older women from two comparable local health centers who scored 26 and higher on Mini-Mental State Examination were invited to participate. Women at one center (experimental group) received three sessions on memory enhancement techniques and a computerized training program with N-back. Women at the other center (control group) received three sessions on memory and aging and training on using various features of cellphones. All participants completed the Corsi Block Task and Digit Span Task at pre- and post-training. The experimental group showed significant improvements in their visuospatial and verbal WM compared to the control group. These findings support the brain's plasticity in the elderly. WM training for improving cognitive performance in older adults has potential and should be further investigated.",2020,The experimental group showed significant improvements in their visuospatial and verbal WM compared to the control group.,"['Older women from two comparable local health centers who scored 26 and higher on Mini-Mental State Examination were invited to participate', 'healthy older women', 'older adults', 'older female adults']","['working memory (WM) training program', 'computer-assisted working memory training program', 'three sessions on memory enhancement techniques and a computerized training program with N-back', 'WM training', 'three sessions on memory and aging and training']","['visuospatial and verbal WM', 'cognitive performance', 'Corsi Block Task and Digit Span Task']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]",,0.0158536,The experimental group showed significant improvements in their visuospatial and verbal WM compared to the control group.,"[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ghavidel', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, Ferdowsi University of Mashhad, 9177948991, Mashhad, Iran.'}, {'ForeName': 'Javad Salehi', 'Initials': 'JS', 'LastName': 'Fadardi', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, Ferdowsi University of Mashhad, 9177948991, Mashhad, Iran. j.s.fadardi@um.ac.ir.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gatto', 'Affiliation': 'Claremont Graduate University, Claremont, CA, USA.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Sedaghat', 'Affiliation': 'Sedaghat Cognitive Neuroscience Clinic, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Tabibi', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, Ferdowsi University of Mashhad, 9177948991, Mashhad, Iran.'}]",Cognitive processing,['10.1007/s10339-020-00975-7']
11,32279416,Preoperative evaluation of microvascular invasion with circulating tumour DNA in operable hepatocellular carcinoma.,"BACKGROUND & AIMS


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


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


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


CtDNA can serve as an independent risk factor of MVI for operable HCC and help determining precise treatment strategies. The integration of ctDNA in the management of operable HCC may achieve better clinical outcomes.",2020,"In univariate analysis, ctDNA allele frequency (AF) and largest tumor diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis.","['operable hepatocellular carcinoma (HCC', 'Seventy-three HCC patients', 'operable hepatocellular carcinoma']",[],"['recurrence-free survival', 'ctDNA AF, AFP level and BCLC staging']","[{'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0017270', 'cui_str': 'Gene frequency'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0332305', 'cui_str': 'With staging'}]",260.0,0.0294222,"In univariate analysis, ctDNA allele frequency (AF) and largest tumor diameter were associated with the presence of MVI, but ctDNA AF was the only independent risk factor in multivariate analysis.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Goldstein', 'Affiliation': 'Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Lianpeng', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Long', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qiongzhi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'Geneplus-Beijing Institute, Beijing, China.'}, {'ForeName': 'Ledu', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14463']
12,32345685,A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial.,"OBJECTIVES


In this study, we evaluate the efficacy of Families Talking Together (FTT), a triadic intervention to reduce adolescent sexual risk behavior.
METHODS


Adolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined. Families were randomly assigned to FTT or 1 of 2 control conditions. The FTT triadic intervention consisted of a 45-minute face-to-face session for mothers, health care provider endorsement of intervention content, printed materials for families, and a booster call for mothers. The primary outcomes were ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse. Assessments occurred at baseline, 3 months post baseline, and 12 months post baseline.
RESULTS


Of enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race. Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade. At the 12-month follow-up, 5.2% of adolescents in the experimental group reported having had sexual intercourse, compared with 18% of adolescents in the control groups ( P  < .05). In the experimental group, 4.7% of adolescents reported sexual debut within the past 12 months, compared with 14.7% of adolescents in the control group ( P  < .05). In the experimental group, 74.2% of sexually active adolescents indicated using a condom at last sexual intercourse, compared with 49.1% of adolescents in the control group ( P  < .05).
CONCLUSIONS


This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.",2020,This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.,"['Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade', 'Adolescent Sexual Health', 'Of enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race', 'Adolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined', 'adolescents']","['FTT triadic intervention', 'FTT', 'triadic intervention', 'Triadic Intervention', 'Families Talking Together']","['sexual intercourse', 'sexual debut', 'ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse', 'sexual risk behavior']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",900.0,0.0590979,This research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.,"[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Guilamo-Ramos', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York; vincent.ramos@nyu.edu.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Benzekri', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Thimm-Kaiser', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dittus', 'Affiliation': 'Division of Sexually Transmitted Disease Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Yumary', 'Initials': 'Y', 'LastName': 'Ruiz', 'Affiliation': 'Center for Latino Adolescent and Family Health, New York University, New York, New York.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'New York University Langone Health, New York, New York; and.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'McCoy', 'Affiliation': 'Morris Heights Health Center, Bronx, New York.'}]",Pediatrics,['10.1542/peds.2019-2808']
13,32350749,A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.,"BACKGROUND


In recent randomized, placebo-controlled, phase III trials, highly purified cannabidiol demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut syndrome or Dravet syndrome. It is anticipated that antiepileptic drugs such as stiripentol and valproate will be administered concomitantly with cannabidiol.
OBJECTIVES


This trial evaluated the effect of cannabidiol on steady-state pharmacokinetics of stiripentol or valproate in patients with epilepsy, and the safety and tolerability of cannabidiol.
METHODS


This phase II, two-arm, parallel-group, double-blind, randomized, placebo-controlled trial recruited male and female patients with epilepsy aged 16-55 years. Patients receiving a stable dose of stiripentol or valproate were randomized 4:1 to receive concomitant double-blind cannabidiol or placebo. Patients received plant-derived, highly purified cannabidiol medicine (Epidiolex ®  in the USA; Epidyolex ®  in the EU; 100 mg/mL oral solution) at a dose of 20 mg/kg/day from day 12 to 26, following a 10-day dose-escalation period. Blood samples for pharmacokinetic evaluations were collected on days 1 and 26 before stiripentol/valproate dosing and up to 12 h postdose. Treatment-emergent adverse events (AEs) were recorded.
RESULTS


In total, 35 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21). Both the safety and the pharmacokinetic populations of the stiripentol arm comprised 14 patients (2 placebo; 12 cannabidiol). The safety population of the valproate arm comprised 20 patients (4 placebo; 16 cannabidiol; one withdrew before receiving treatment); the pharmacokinetic population comprised 15 patients (3 placebo; 12 cannabidiol). Concomitant cannabidiol led to a small increase in stiripentol exposure (17% increase in maximum observed plasma concentration [C max ]; 30% increase in area under the concentration-time curve over the dosing interval [AUC tau ]). Concomitant cannabidiol also had little effect on valproate exposure (13% decrease in C max ; 17% decrease in AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA) (23% decrease in C max ; 30% decrease in AUC tau ). All changes in exposure are expressed as the dose-normalized geometric mean (CV%) day 26 to day 1 ratio. The most common AE was diarrhea; most AEs were mild. Two patients discontinued cannabidiol because of serious AEs (rash [n = 1] in the stiripentol arm; hypertransaminasemia [n = 1] in the valproate arm). A separate in vitro study investigated the bidirectional effect of cannabidiol, or its metabolite 7-carboxy-cannabidiol, on valproate plasma protein binding; no change in plasma protein binding was observed for either compound.
CONCLUSIONS


The clinical relevance of the increase in stiripentol exposure is unknown; patients receiving cannabidiol and stiripentol concomitantly should be monitored for adverse reactions as individual patient responses may vary. Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy. Safety results were consistent with the known safety profile of cannabidiol at a dose of 20 mg/kg/day. Clinicaltrials.gov: NCT02607891.",2020,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","['Patients receiving a stable dose of', 'controlled trial recruited male and female patients with epilepsy aged 16-55 years', '20 patients (4', 'patients with epilepsy', 'adult patients with epilepsy', 'In total,\xa035 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21', 'Patients with Epilepsy', 'patients with Lennox-Gastaut syndrome or Dravet syndrome']","['concomitant double-blind cannabidiol or placebo', 'placebo', 'valproate', 'Stiripentol or Valproate', 'plant-derived, highly purified cannabidiol medicine (Epidiolex ®  in the USA; Epidyolex ®  in the EU; 100 mg/mL oral solution', 'stiripentol or valproate']","['stiripentol exposure', 'valproate exposure', 'AUC tau ) or its metabolite, 2-propyl-4-pentenoic acid (4-ene-VPA', 'plasma protein binding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}]","[{'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0046536', 'cui_str': '2-propyl-4-pentenoic acid'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",35.0,0.419758,"Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy.","[{'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Clinical Neuroscience at Institute of Neuroscience and Physiology, Neurologen, University of Gothenburg, Blå Stråket 7, Plan 0, 41345, Gothenburg, Sweden. elinor.ben-menachem@neuro.gu.se.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.'}, {'ForeName': 'Carmen María', 'Initials': 'CM', 'LastName': 'Arenas Cabrera', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Kevan', 'Initials': 'K', 'LastName': 'VanLandingham', 'Affiliation': 'Greenwich Biosciences, Inc., Carlsbad, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Wray', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Toledo', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]",CNS drugs,['10.1007/s40263-020-00726-4']
14,32348739,Limited Efficacy of Thrombolytics for Pump Thrombosis in Durable Left Ventricular Assist Devices.,"BACKGROUND


This study reports a single-center experience with thrombolytics for left ventricular assist device (LVAD) pump thrombosis.
METHODS


Adults undergoing continuous-flow LVAD implantation between 2004 and 2018 at a single center were reviewed and those with pump thrombosis were identified. Primary outcomes included 1-year survival and success rates of thrombolytic therapy. Secondary outcomes included posttreatment adverse events, freedom from major bleeding at 1 year, and freedom from stroke at 1-year follow-up.
RESULTS


A total of 341 patients underwent LVAD implantation and 10.8% (n = 37) developed pump thrombosis. Of those 37, 26 received initial thrombolytic therapy (70.2%), 5 underwent direct pump exchange (13.5%), and 6 received only intravenous heparin owing to presentation with acute stroke or severe multiorgan failure (16.2%). Successful treatment was achieved in 11.5% of patients receiving thrombolytics (n = 3). Early adverse events after thrombolytic therapy included major bleeding in 11.5% (n = 3) and new stroke in 7.7% (n = 2). Most patients undergoing thrombolytic therapy underwent subsequent device exchange (69.2%; n = 18). Overall survival in patients with pump thrombosis after treatment was 96.8% at 30 days, 78.9% at 90 days, and 63.1% at 1 year. Freedom from major bleeding and stroke at 1 year was 74.2% and 87.2%, respectively.
CONCLUSIONS


In this single-center experience of thrombolytics for pump thrombosis in LVAD patients, there was limited efficacy; most patients required subsequent pump exchange. Combined with the risk for major bleeding or stroke with thrombolysis, this underscores the importance of further refining patient selection for direct pump exchange in those presenting with pump thrombosis.",2020,"The overall survival in patients with pump thrombosis following treatment was 96.8% at 30-days, 78.9% at 90-days, and 63.1% at 1-year.","['LVAD patients', '341 patients underwent', 'Adults undergoing continuous-flow LVAD implantation between 2004-2018 at a single center were reviewed and those with pump thrombosis identified']","['initial thrombolytic therapy', 'thrombolytic therapy', 'heparin', 'LVAD implantation']","['post-treatment adverse events, freedom from major bleeding at 1-year and freedom from stroke at 1-year follow-up', 'pump thrombosis', 'overall survival', '1-year survival and success rates of thrombolytic therapy', 'major bleeding', 'new stroke']","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}]",341.0,0.223001,"The overall survival in patients with pump thrombosis following treatment was 96.8% at 30-days, 78.9% at 90-days, and 63.1% at 1-year.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seese', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Floyd', 'Initials': 'F', 'LastName': 'Thoma', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: kilica2@upmc.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.061']
15,32348825,"Treatment of hidradenitis suppurativa using a long-pulsed hair removal neodymium:yttrium-aluminium-garnet laser: A multicenter, prospective, randomized, intraindividual, comparative trial.",,2020,,[],['hidradenitis suppurativa using long-pulsed hair removal'],[],[],"[{'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018504', 'cui_str': 'Epilation'}]",[],,0.0168988,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Naouri', 'Affiliation': 'Dermatological and Esthetical Laser Center, Nogent sur Marne, France; Laser Center, Department of Dermatology, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Maruani', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Régional Universitaire Tours, France; University of Tours, Inserm 1246-SPHERE, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lagrange', 'Affiliation': ""Université Côte d'Azur, Department of Dermatology, Centre Hospitalier Régional Universitaire Nice, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Cogrel', 'Affiliation': 'Dermatologic Surgery, Mohs Surgery and Laser Unit, Dermatology Department, University Hospital of Bordeaux, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Servy', 'Affiliation': 'Dermatological and Esthetical Laser Center, Nogent sur Marne, France.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Collet Vilette', 'Affiliation': 'Dermatological Laser Center, Hôpital de la Conception, Marseille, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Fourcade', 'Affiliation': 'Dermatological Laser Center, Hôpital de la Conception, Marseille, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gral', 'Affiliation': 'Dermatological and Esthetical Laser Center, Grenoble, France.'}, {'ForeName': 'Yvon', 'Initials': 'Y', 'LastName': 'Perrillat', 'Affiliation': 'Dermatological and Esthetical Laser Center, Grenoble, France.'}, {'ForeName': 'Regine Bousquet', 'Initials': 'RB', 'LastName': 'Rouaud', 'Affiliation': 'Dermatological and Esthetical Laser Center of Arche, Montpellier, France; Millénaire Clinic, Montpellier, France.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Cartier', 'Affiliation': 'Saint-Jean Medical Center, Arras, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Maire', 'Affiliation': 'Saint-Jean Medical Center, Arras, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boineau', 'Affiliation': 'Aesthetic Dermatology Office, Bordeaux, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Toubel', 'Affiliation': 'Private Practice, Rennes, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ollivier', 'Affiliation': 'Private Practice, Rennes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Pillouer-Prost', 'Affiliation': 'Clairval Private Hospital, Marseille, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Université Côte d'Azur, Department of Dermatology, Centre Hospitalier Régional Universitaire Nice, France; Université Côte d'Azur, Inserm U1065, Nice, France. Electronic address: passeron@unice.fr.""}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.117']
16,32353536,Agreement of Spectral-Domain OCT with Fluorescein Leakage in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study.,"PURPOSE


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


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


Patients with neovascular AMD in the HARBOR Trial.
METHODS


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


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


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


Spectral-domain OCT alone can be relied upon for detecting CNV activity while monitoring eyes with neovascular AMD. However, FFA may still be of value in those with occult lesions that appear quiescent on SD OCT, as this type of lesion may show leakage on FFA.",2020,"By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only.","['neovascular age-related macular degeneration (AMD) by fundus', 'Neovascular Age-related Macular Degeneration', ' Baseline to Month 24 data from all randomized study eyes in HARBOR with both FFA and SD-OCT data']","['Spectral Domain Optical Coherence Tomography with Fluorescein Leakage', 'FFA', 'fluorescein angiography (FFA) and spectral domain (SD)- optical coherence tomography (OCT', 'choroidal neovascularization (CNV', 'OCT']","['CNV activity', 'occult CNV lesions', 'CNV activity on SD-OCT', 'sensitivity and specificity of SD-OCT in detecting CNV activity']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0430878', 'cui_str': 'Posterior segment fluorescein angiography'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}]","[{'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]",,0.0420517,"By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only.","[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.016']
17,32352803,"Condensing parent training: A randomized trial comparing the efficacy of a briefer, more intensive version of Parent-Child Interaction Therapy (I-PCIT).","OBJECTIVE


The current study examined the comparative efficacy of a more intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over 2 weeks) versus a time-limited weekly PCIT format (1 day/week over 10 weeks) in treating early childhood externalizing behavior problems.
METHOD


Using a randomized trial design, 60 young children (mean age [ M age ] = 4.33 years; 65% male; 85% Latinx) with clinically elevated levels of externalizing behavior problems and their parents were assigned to either I-PCIT ( n  = 30) or time-limited PCIT ( n  = 30). Families completed pre-, post-, and follow-up assessments 6-9 months following treatment completion. Parents completed measures of child behavior, discipline practices, and parenting stress. Observational data on child behavior and parenting were also collected.
RESULTS


Noninferiority and multivariate repeated-measures analyses indicated comparable improvements across 6 out of 7 observed and parent-reported outcomes, including parenting skills, discipline practices, and child externalizing behavior problems at posttreatment. Comparable treatment gains remained at follow-up, with the caveat that parents in time-limited PCIT reported lower externalizing behavior problems compared with I-PCIT, although both groups were still significantly better compared with pretreatment. Lastly, moderation analyses indicated that parents experiencing high levels of stress benefited more from I-PCIT in terms of decreasing child externalizing behavior compared with time-limited PCIT.
CONCLUSIONS


I-PCIT appears to be a viable treatment option for families, especially those experiencing high levels of stress, in terms of targeting early externalizing behavior problems within a short period of time. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Noninferiority and multivariate repeated-measures analyses indicated comparable improvements across 6 out of 7 observed and parent-reported outcomes, including parenting skills, discipline practices, and child externalizing behavior problems at posttreatment.",['60 young children (mean age [ M age ] = 4.33 years; 65% male; 85% Latinx) with clinically elevated levels of externalizing behavior problems and their parents'],"['time-limited PCIT', 'intensive version of Parent-Child Interaction Therapy (I-PCIT', 'I-PCIT']","['externalizing behavior problems', 'child behavior, discipline practices, and parenting stress', 'child externalizing behavior', 'parenting skills, discipline practices, and child externalizing behavior problems']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.0418372,"RESULTS


Noninferiority and multivariate repeated-measures analyses indicated comparable improvements across 6 out of 7 observed and parent-reported outcomes, including parenting skills, discipline practices, and child externalizing behavior problems at posttreatment.","[{'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Graziano', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Rosmary', 'Initials': 'R', 'LastName': 'Ros-Demarize', 'Affiliation': 'Department of Pediatrics, Division of Developmental-Behavioral Pediatrics, Medical University of South Carolina.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Hare', 'Affiliation': 'Department of Psychology, Florida International University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000504']
18,32357107,Examining the Impact of the SDLMI and Whose Future Is It? Over a Two-Year Period With Students With Intellectual Disability.,"The purpose of this study was to examine self-determination outcome data in the year following a one-year cluster randomized controlled trial (C-RCT) comparing the impacts of a Self-Determined Learning Model of Instruction (SDLMI) only condition to a SDLMI +  Whose Future Is It?  (SDLMI + WF) condition. Using multilevel B-spline model analysis with Bayesian estimation, we examined ongoing patterns of growth after the trial ended and all students were exposed to SDLMI + WF. The findings suggest that the inclusion of an additional year of outcome data provided additional insight into the impact of more intensive intervention conditions over time. Specifically, after the initial year of implementation, the SDLMI + WF condition predicted greater annual gains than the SDLMI only condition, unlike findings in the first year which reflected the opposite pattern. This evidence suggests a nonlinear growth pattern over multiple years of intervention with more intensive interventions. Implications for future research and practice are discussed.",2020,"Specifically, after the initial year of implementation, the SDLMI + WF condition predicted greater annual gains than the SDLMI only condition, unlike findings in the first year which reflected the opposite pattern.",['Students With Intellectual Disability'],"['Self-Determined Learning Model of Instruction (SDLMI', 'SDLMI + WF', 'SDLMI ']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]",[],,0.034835,"Specifically, after the initial year of implementation, the SDLMI + WF condition predicted greater annual gains than the SDLMI only condition, unlike findings in the first year which reflected the opposite pattern.","[{'ForeName': 'Karrie A', 'Initials': 'KA', 'LastName': 'Shogren', 'Affiliation': 'Karrie A. Shogren and Tyler A. Hicks, University of Kansas; Kathryn M. Burke, Temple University; Anthony Antosh, and Terri LaPlante, Rhode Island College; and Mark H. Anderson, University of Kansas.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Hicks', 'Affiliation': 'Karrie A. Shogren and Tyler A. Hicks, University of Kansas; Kathryn M. Burke, Temple University; Anthony Antosh, and Terri LaPlante, Rhode Island College; and Mark H. Anderson, University of Kansas.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Burke', 'Affiliation': 'Karrie A. Shogren and Tyler A. Hicks, University of Kansas; Kathryn M. Burke, Temple University; Anthony Antosh, and Terri LaPlante, Rhode Island College; and Mark H. Anderson, University of Kansas.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Antosh', 'Affiliation': 'Karrie A. Shogren and Tyler A. Hicks, University of Kansas; Kathryn M. Burke, Temple University; Anthony Antosh, and Terri LaPlante, Rhode Island College; and Mark H. Anderson, University of Kansas.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'LaPlante', 'Affiliation': 'Karrie A. Shogren and Tyler A. Hicks, University of Kansas; Kathryn M. Burke, Temple University; Anthony Antosh, and Terri LaPlante, Rhode Island College; and Mark H. Anderson, University of Kansas.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Anderson', 'Affiliation': 'Karrie A. Shogren and Tyler A. Hicks, University of Kansas; Kathryn M. Burke, Temple University; Anthony Antosh, and Terri LaPlante, Rhode Island College; and Mark H. Anderson, University of Kansas.'}]",American journal on intellectual and developmental disabilities,['10.1352/1944-7558-125.3.217']
19,32354280,Reduced Diuretic Dose in Patients Treated With Eplerenone: Data From the EPHESUS Trial.,"BACKGROUND


Loop diuretics are used for congestion relief, and dose adaptations are usually a consequence of the clinicians' clinical judgement about the congestive status of the patient. In EPHESUS (Eplerenone in Patients With Systolic Dysfunction After Myocardial Infarction), many patients required diuretics for congestion relief. We thus hypothesized that blinded allocation to eplerenone would lead clinicians to reduce loop diuretics, as a consequence of the improvement in patients' status.
METHODS


Cox and mixed-effects models were used over a median follow-up of 1.3 years in 6632 patients.
RESULTS


A total of 6632 patients were included; at baseline, 3352 (50.5%) did not have diuretics, 2195 (33.1%) had diuretic doses between 1 and 40 mg/day, and 1085 (16.4%) had diuretic doses >40 mg/day. Patients with higher furosemide equivalent doses had a worse clinical status. Both baseline and follow-up incremental loop diuretic doses were associated with worse prognosis. Eplerenone treatment was associated with lower prescribed loop diuretic doses throughout the follow-up; lower doses were observed at 90 days and decreased further at 180 days and beyond. Eplerenone treatment led to a mean furosemide equivalent dose reduction of -2.2 mg/day (-2.9 to -1.6) throughout the follow-up. Eplerenone was effective in reducing morbidity and mortality regardless of the baseline loop diuretic dose used: hazard ratio for the outcome of cardiovascular death or heart failure hospitalization was 0.83 ([95% CI, 0.75-0.92];  P  for interaction, 0.54).
CONCLUSIONS


Eplerenone treatment led to a loop diuretic dose reduction during follow-up without evidence of treatment effect modification by loop diuretics. These findings suggest that eplerenone reduces congestive signs and symptoms, which enables clinicians to reduce loop diuretic doses.",2020,Eplerenone treatment was associated with lower prescribed loop diuretic doses throughout the follow-up; lower doses were observed at 90 days and decreased further at 180 days and beyond.,"['A total of 6632 patients were included; at baseline, 3352 (50.5%) did not have diuretics, 2195 (33.1%) had diuretic doses between 1 and 40 mg/day, and 1085 (16.4%) had diuretic doses', 'Patients With Systolic Dysfunction', '6632 patients']","['eplerenone', 'Eplerenone']","['morbidity and mortality', 'congestion relief', 'cardiovascular death or heart failure hospitalization']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",6632.0,0.157846,Eplerenone treatment was associated with lower prescribed loop diuretic doses throughout the follow-up; lower doses were observed at 90 days and decreased further at 180 days and beyond.,"[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Eschalier', 'Affiliation': 'Département de Cardiologie, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, France (R.E.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Duarte', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, the Netherlands (K. Damman).'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (F.G.).'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Clinical Medicine (F.G., M.S.), University of Copenhagen, Denmark.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Fay', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Tala', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan, Ann Arbor (B.P.).'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Universite de Lorraine, Clinical Investigation Center 1433, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, INSERM Unite 1116 (J.P.F., K. Duarte, N.G., R.F., S.T., F.Z., P.R.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006597']
20,32367234,Is selective nerve root block necessary for learning percutaneous endoscopic lumbar discectomy: a comparative study using a cumulative summation test for learning curve.,"PURPOSE


The aim of this study was to investigate the effect of lumbar spine selective nerve root block (SNRB) experience on the learning efficiency of percutaneous endoscopic lumbar discectomy (PELD) for junior trainees.
METHODS


A total of 480 patients undergoing single-level PELD performed by eight junior trainees were included. The trainees were divided into two groups based on whether they had previous SNRB experience (group A, yes; group B, no). Surgical proficiency was defined as total operation time less than 65 minutes and cumulative radiation exposure time no more than 40 seconds. The learning curve was analyzed by cumulative summation (CUSUM) test. Clinical evaluations included Macnab classification, visual analog scale (VAS)-low back score, VAS-leg score, and Oswestry Disability Index (ODI). Follow-up information at 12 months was also obtained.
RESULTS


Integral number of cases before achieving an acceptable surgical level in group A (47.75 ± 2.50 cases) was significantly smaller than that in group B (56.50 ± 1.29 cases, p < 0.05), along with less accumulated failure (18.75 ± 0.96 cases vs. 25.50 ± 1.75 cases, p < 0.05). The two groups were comparable in clinical outcomes. Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05).
CONCLUSION


Previous experience of SNRB improved the performance of PELD with shorter operation time and less radiation exposure. SNRB practice may reduce the complication rate without a significant effect on the recurrence of symptoms and reoperation.",2020,"Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05).
","['junior trainees', '480 patients undergoing single-level PELD performed by eight junior trainees were included']","['lumbar spine selective nerve root block (SNRB) experience', 'percutaneous endoscopic lumbar discectomy (PELD']","['total operation time less', 'complications', 'acceptable surgical level', 'cumulative radiation exposure time', 'complication rate', 'recurrence of symptoms and reoperation', 'Macnab classification, visual analog scale (VAS)-low back score, VAS-leg score, and Oswestry Disability Index (ODI']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0228084', 'cui_str': 'Nerve root structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",480.0,0.0260394,"Forty-seven cases of complications were observed, with 17 in group A and 30 in group B (p < 0.05).
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Huiqiao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Yunhao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Orthopaedics, The 455th Hospital of Chinese People's Liberation Army, Shanghai, China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. guxin2004ty@163.com.""}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China. charlieshi@smmu.edu.cn.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, People's Republic of China.""}]",International orthopaedics,['10.1007/s00264-020-04558-1']
21,32353206,Effects of individual pelvic floor muscle training vs individual training progressing to group training vs group training alone in women with stress urinary incontinence: A randomized clinical trial.,"AIMS


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


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


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


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


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


PFM training improved the severity of urinary incontinence in all groups after 12 sessions of training supervised by a physical therapist. IT progressing to GT improved the function of upper PFM when compared to the other groups.",2020,"After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56).","['women with stress urinary incontinence (SUI', 'women with stress urinary incontinence', '90 women with SUI']","['IT, GT, or four individual sessions progressing to group training (IPGT', 'individual pelvic floor muscle training vs individual training progressing to group training vs group training alone', 'individual pelvic floor muscle (PFM) training vs individual training (IT) progressing to group training (GT) vs group-only training', 'PFM training', 'direct supervision by a physical therapist']","['PFM function by palpation and manometer, bladder and exercise diaries, PFM training adherence, and self-efficacy', 'severity of urinary incontinence', 'PFM function', 'severity measure', 'function of upper PFM', ""severity according to the King's Health Questionnaire""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",90.0,0.0228563,"After the intervention, the severity measure improved in all three groups (P < .001), without difference between them (P = .56).","[{'ForeName': 'Vilena B', 'Initials': 'VB', 'LastName': 'Figueiredo', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Simony L', 'Initials': 'SL', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'Renata F L', 'Initials': 'RFL', 'LastName': 'Martínez', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Clara T S', 'Initials': 'CTS', 'LastName': 'Lima', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of Ceará (UFC), Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Cristine H J', 'Initials': 'CHJ', 'LastName': 'Ferreira', 'Affiliation': 'Department of Health Sciences, Health Science Department, University of São Paulo (USP), Ribeirão Preto-SP, São Paulo, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': 'Physical Therapy\xa0Department, Federal University of São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24370']
22,32356926,Telmisartan as tentative angiotensin receptor blocker therapeutic for COVID-19.,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic. This new disease was named COVID-19 and the causative virus SARS-CoV-2. The SARS-CoV-2 virus enters the airway and binds, by means of the S protein on its surface to the membrane protein ACE2 in type 2 alveolar cells. The S protein-ACE2 complex is internalized by endocytosis leading to a partial decrease or total loss of the enzymatic function ACE2 in the alveolar cells and in turn increasing the tissue concentration of pro-inflammatory angiotensin II by decreasing its degradation and reducing the concentration of its physiological antagonist angiotensin 1-7. High levels of angiotensin II on the lung interstitium can promote apoptosis initiating an inflammatory process with release of proinflammatory cytokines, establishing a self-powered cascade, leading eventually to ARDS. Recently, Gurwitz proposed the tentative use of agents such as losartan and telmisartan as alternative options for treating COVID-19 patients prior to development of ARDS. In this commentary article, the authors make the case for the election of telmisartan as such alternative on the basis of its pharmacokinetic and pharmacodynamic properties and present an open-label randomized phase II clinical trial for the evaluation of telmisartan in COVID-19 patients (NCT04355936).",2020,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic.",[],"['Telmisartan', 'telmisartan', 'losartan and telmisartan']",[],[],"[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]",[],,0.0151336,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic.","[{'ForeName': 'Rodolfo Pedro', 'Initials': 'RP', 'LastName': 'Rothlin', 'Affiliation': 'Sociedad Argentina de Farmacología Clínica, Asociación Médica Argentina, Buenos Aires, Argentina.'}, {'ForeName': 'Héctor Miguel', 'Initials': 'HM', 'LastName': 'Vetulli', 'Affiliation': 'Servicio de Electrofisiología Cardíaca, Arritmias y Marcapasos, Sanatorio Otamendi y Miroli, Buenos Aires, Argentina.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': 'Hospital de Clínicas ""José de San Martín"", Facultad de Medicina, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Facundo Germán', 'Initials': 'FG', 'LastName': 'Pelorosso', 'Affiliation': 'Department of Pathology, Hospital de Alta Complejidad El Calafate SAMIC, Santa Cruz, Argentina.'}]",Drug development research,['10.1002/ddr.21679']
23,32356212,Diode laser surgery versus electrocautery in the treatment of inflammatory fibrous hyperplasia: a randomized double-blind clinical trial.,"OBJECTIVES


To compare the efficacy and safety of diode laser and electrocautery techniques for inflammatory fibrous hyperplasia (IFH) removal.
MATERIALS AND METHODS


In this randomized double-blind clinical trial, 40 individuals were randomly allocated to two groups: group 1 (G1) consisted of 20 individuals assigned to treatment with diode laser and group 2 (G2) consisted of 20 individuals assigned to treatment with electrocautery. The following transoperative parameters were evaluated: bleeding, temperature, and surgical technique parameters (energy deposited on tissue, flow rate, and time of incision). The postoperative parameters evaluated were as follows: pain, functional alterations (chewing, speaking), analgesic medication intake, swelling, healing of the wound area, and patient satisfaction.
RESULTS


Among the 40 individuals included in the study, four (two in G1 and two in G2) did not complete the entire follow-up. Therefore, 36 individuals (18 in G1 and 18 in G2) participated. Participants in G1 and in G2 had similar demographic characteristics. No difference regarding the trans- or postoperative parameters evaluated was observed between G1 and G2 (p > 0.05). Also, no difference regarding the time for healing was observed between groups.
CONCLUSIONS


Diode laser seems to be as effective and safe as electrocautery when applied under similar conditions for IFH removal.
CLINICAL RELEVANCE


IFH corresponds to 65% of the lesions observed in denture wearers. This study shows that under similar conditions diode laser is as effective and safe as electrocautery for removal of IFH.",2020,"CONCLUSIONS


Diode laser seems to be as effective and safe as electrocautery when applied under similar conditions for IFH removal.
","['inflammatory fibrous hyperplasia', '40 individuals', '36 individuals (18 in G1 and 18 in G2) participated']","['diode laser and group 2 (G2) consisted of 20 individuals assigned to treatment with electrocautery', 'Diode laser surgery versus electrocautery', 'Diode laser', 'diode laser', 'diode laser and electrocautery techniques']","['bleeding, temperature, and surgical technique parameters (energy deposited on tissue, flow rate, and time of incision', 'pain, functional alterations (chewing, speaking), analgesic medication intake, swelling, healing of the wound area, and patient satisfaction', 'time for healing', 'efficacy and safety', 'trans- or postoperative parameters']","[{'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.271442,"CONCLUSIONS


Diode laser seems to be as effective and safe as electrocautery when applied under similar conditions for IFH removal.
","[{'ForeName': 'Alessandro Oliveira', 'Initials': 'AO', 'LastName': 'de Jesus', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Michelle Danielle Porto', 'Initials': 'MDP', 'LastName': 'Matias', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'José Alcides Almeida', 'Initials': 'JAA', 'LastName': 'de Arruda', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Amanda Vieira', 'Initials': 'AV', 'LastName': 'Aires', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Isadora Pereira', 'Initials': 'IP', 'LastName': 'Gomes', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Leandro Napier', 'Initials': 'LN', 'LastName': 'Souza', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Lucas Guimarães', 'Initials': 'LG', 'LastName': 'Abreu', 'Affiliation': ""Department of Child's and Adolescent's Oral Health, School of Dentistry, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627, room 3322, Pampulha, Belo Horizonte, MG, 31270-901, Brazil. lucasgabreu01@gmail.com.""}, {'ForeName': 'Ricardo Alves', 'Initials': 'RA', 'LastName': 'Mesquita', 'Affiliation': 'Department of Oral Surgery and Pathology, School of Dentistry, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03296-3']
24,32367611,Accommodative dynamics and attention: the influence of manipulating attentional capacity on accommodative lag and variability.,"PURPOSE


There is evidence that attention can modulate ocular dynamics, but its effects on accommodative dynamics have yet to be fully determined. We investigated the effects of manipulating the capacity to focus on task-relevant stimuli, using two levels of dual-tasking (arithmetic task) and auditory feedback, on the accommodative dynamics at three different target distances (500, 40 and 20 cm).
METHODS


The magnitude and variability of the accommodative response were objectively measured in 20 healthy young adults using the Grand Seiko WAM-5500 autorefractor. In randomised order, participants fixated on a Maltese cross while 1) performing an arithmetic task with two levels of complexity (low and high mental load); 2) being provided with two levels of auditory feedback (low and high feedback); and 3) without performing any mental task or receiving feedback (control). Accommodative and pupil dynamics were monitored for 90 seconds during each of the 15 trials (5 experimental conditions x 3 target distances).
RESULTS


The lag of accommodation was sensitive to the attentional state (p = 0.001), where a lower lag of accommodation was observed for the high feedback condition compared to the control (corrected p-value = 0.009). The imposition of mental load while fixating on a distant target led to a greater accommodative response (corrected p-value = 0.010), but no effects were found for the near targets. There was a main effect of the experimental manipulation on the accommodative variability (p < 0.001), with the use of auditory feedback improving the accuracy of the accommodative system.
CONCLUSIONS


Our data show that accommodative dynamics is affected by varying the capacity to focus on task-relevant stimuli, observing an improvement in accommodative stability and response with auditory feedback. These results highlight an association between attention and ocular dynamics and provide new insight into the control of accommodation.",2020,"The lag of accommodation was sensitive to the attentional state (p = 0.001), where a lower lag of accommodation was observed for the high feedback condition compared to the control (corrected p-value = 0.009).",['20 healthy young adults using the Grand Seiko WAM-5500 autorefractor'],['participants fixated on a Maltese cross while 1) performing an arithmetic task with two levels of complexity (low and high mental load); 2) being provided with two levels of auditory feedback (low and high feedback); and 3) without performing any mental task or receiving feedback (control'],"['accommodative stability and response with auditory feedback', 'lag of accommodation was sensitive to the attentional state', 'lag of accommodation', 'accommodative response', 'accommodative variability', 'dual-tasking (arithmetic task) and auditory feedback', 'Accommodative and pupil dynamics']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1275634', 'cui_str': 'Automated infrared optometer'}]","[{'cui': 'C0324395', 'cui_str': 'Maltese dog'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0332324', 'cui_str': 'Sensitive'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",20.0,0.0395495,"The lag of accommodation was sensitive to the attentional state (p = 0.001), where a lower lag of accommodation was observed for the high feedback condition compared to the control (corrected p-value = 0.009).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, University of Granada, Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, University of Granada, Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina', 'Affiliation': 'Department of Optics, University of Granada, Granada, Spain.'}, {'ForeName': 'Leon N', 'Initials': 'LN', 'LastName': 'Davies', 'Affiliation': 'School of Optometry, Aston University, Birmingham, UK.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, University of Granada, Granada, Spain.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12690']
25,32362166,Effects of Liraglutide on Worsening Renal Function Among Patients With Heart Failure With Reduced Ejection Fraction: Insights From the FIGHT Trial.,"BACKGROUND


The FIGHT (Functional Impact of GLP-1 [glucagon-like peptide-1] for Heart Failure Treatment) trial randomized 300 patients with heart failure with reduced ejection fraction (HFrEF) and a recent hospitalization for heart failure to liraglutide versus placebo. While there was no difference in the primary outcome (rank score of time to death, time to rehospitalization for heart failure, and change in NT-proBNP [N-terminal pro-B-type natriuretic peptide]), there was a significant increase in cystatin C among patients randomized to liraglutide raising concern of adverse renal outcomes. We performed a post hoc analysis of FIGHT to investigate whether liraglutide was associated with worsening renal function (WRF).
METHODS


The relationship between randomization to liraglutide and WRF was evaluated using logistic regression models. Two hundred seventy-four patients (91%) had complete data to assess for WRF defined as: increase in SCr ≥0.3 mg/dL, or ≥25% decrease in estimated glomerular filtration rate, or an increase in cystatin C ≥0.3 mg/L from baseline to 180-days.
RESULTS


Patients with WRF (n=113, 41%), compared with those without, were older, had more comorbidities, and lower utilization of guideline-directed medical treatment. Logistic regression models showed that age and baseline cystatin C levels were associated with WRF. In adjusted models, liraglutide was not associated with excess risk of WRF compared with placebo (odds ratio, 1.02 [95% CI, 0.62-1.67]). There was also no difference in the rank score when WRF was added as a fourth-tier outcome.
CONCLUSIONS


Liraglutide was not associated with WRF among patients with HFrEF and a recent hospitalization for heart failure. These data support the relative renal safety profile of liraglutide among patients with HFrEF. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01800968.",2020,"In adjusted models, liraglutide was not associated with excess risk of WRF compared with placebo (odds ratio, 1.02 [95% CI, 0.62-1.67]).","['patients with HFrEF', 'Patients With Heart Failure With Reduced Ejection Fraction', '300 patients with heart failure with reduced ejection fraction (HFrEF) and a recent hospitalization for heart failure to']","['liraglutide versus placebo', 'glucagon-like peptide-1', 'GLP-1', 'liraglutide', 'Liraglutide', 'placebo']","['excess risk of WRF', 'cystatin C', 'estimated glomerular filtration rate', 'Worsening Renal Function', 'primary outcome (rank score of time to death, time to rehospitalization for heart failure, and change in NT-proBNP [N-terminal pro-B-type natriuretic peptide', 'worsening renal function (WRF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",300.0,0.241195,"In adjusted models, liraglutide was not associated with excess risk of WRF compared with placebo (odds ratio, 1.02 [95% CI, 0.62-1.67]).","[{'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Redouane', 'Affiliation': 'McGill University Health Centre, McGill University, Montreal, QC, Canada (B.R., A.S.).'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (M.V.).""}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Cardiology, The Permanente Medical Group, San Francisco, CA (A.P.A.).'}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (S.J.G., M.F., J.-L.S., A.D.D, S.E.M., R.J.M., A.F.H., G.M.F.).'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Cooper', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA (L.B.C.).'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Division of Circulatory Failure, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (B.A.B.).'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Yale University School of Medicine, New Haven, CT (E.J.V.).'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Margulies', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia (K.B.M.).'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, McGill University, Montreal, QC, Canada (B.R., A.S.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006758']
26,32365355,L-Thyroxine Therapy for Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms: Secondary Analysis of a Randomized Trial.,"BACKGROUND


L-thyroxine does not improve hypothyroid symptoms among adults with subclinical hypothyroidism (SCH). However, those with greater symptom burden before treatment may still benefit.
OBJECTIVE


To determine whether L-thyroxine improves hypothyroid symptoms and tiredness among older adults with SCH and greater symptom burden.
DESIGN


Secondary analysis of the randomized, placebo-controlled trial TRUST (Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism Trial). (ClinicalTrials.gov: NCT01660126).
SETTING


Switzerland, Ireland, the Netherlands, and Scotland.
PARTICIPANTS


638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data.
INTERVENTION


L-thyroxine or matching placebo with mock dose titration.
MEASUREMENTS


1-year change in Hypothyroid Symptoms and Tiredness scores (range, 0 to 100; higher scores indicate more symptoms) on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire among participants with high symptom burden (baseline Hypothyroid Symptoms score >30 or Tiredness score >40) versus lower symptom burden.
RESULTS


132 participants had Hypothyroid Symptoms scores greater than 30, and 133 had Tiredness scores greater than 40. Among the group with high symptom burden, the Hypothyroid Symptoms score improved similarly between those receiving L-thyroxine (mean within-group change, -12.3 [95% CI, -16.6 to -8.0]) and those receiving placebo (mean within-group change, -10.4 [CI, -15.3 to -5.4]) at 1 year; the adjusted between-group difference was -2.0 (CI, -5.5 to 1.5;  P  = 0.27). Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0;  P  = 0.99). There was no evidence that baseline Hypothyroid Symptoms score or Tiredness score modified the effects of L-thyroxine versus placebo ( P  for interaction = 0.20 and 0.82, respectively).
LIMITATION


Post hoc analysis, small sample size, and examination of only patients with 1-year outcome data.
CONCLUSION


In older adults with SCH and high symptom burden at baseline, L-thyroxine did not improve hypothyroid symptoms or tiredness compared with placebo.
PRIMARY FUNDING SOURCE


European Union FP7.",2020,"Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99).","['Untreated Older Adults with Subclinical Hypothyroidism Trial', '132 participants had', 'adults with subclinical hypothyroidism (SCH', 'Older Adults With Subclinical Hypothyroidism and Hypothyroid Symptoms', 'Participants\n\n\n638 persons aged 65 years or older with persistent SCH (thyroid-stimulating hormone level of 4.60 to 19.9 mIU/L for >3 months and normal free thyroxine level) and complete outcome data', 'older adults with SCH and greater symptom burden']","['Intervention\n\n\nL-thyroxine or matching placebo', 'L-thyroxine', 'placebo-controlled trial TRUST (Thyroid Hormone Replacement', 'L-Thyroxine Therapy', '\n\n\nL-thyroxine', 'placebo']","['Hypothyroid Symptoms score', 'hypothyroid symptoms and tiredness', 'Hypothyroid Symptoms scores', 'Hypothyroid Symptoms and Tiredness scores', 'hypothyroid symptoms or tiredness', 'baseline Hypothyroid Symptoms score or Tiredness score', 'Tiredness scores', 'hypothyroid symptoms']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0439462', 'cui_str': 'mIU/L'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0861033', 'cui_str': 'Thyroxine free normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",638.0,0.652293,"Improvements in Tiredness scores were also similar between those receiving L-thyroxine (mean within-group change, -8.9 [CI, -14.5 to -3.3]) and those receiving placebo (mean within-group change, -10.9 [CI, -16.0 to -5.8]); the adjusted between-group difference was 0.0 (CI, -4.1 to 4.0; P = 0.99).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Montmollin', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Beglinger', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (D.A.).'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, and University of Lausanne, Lausanne, Switzerland (T.C.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland (A.M., I.F.).'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kearney', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland (P.M.K.).'}, {'ForeName': 'Vera J C', 'Initials': 'VJC', 'LastName': 'McCarthy', 'Affiliation': 'School of Nursing and Midwifery, University College Cork, Cork, Ireland (V.J.M.).'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Mooijaart', 'Affiliation': 'Institute for Evidence-based Medicine in Old Age, Leiden University Medical Center, Leiden, the Netherlands (S.M.).'}, {'ForeName': 'Rosalinde K E', 'Initials': 'RKE', 'LastName': 'Poortvliet', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands (J.G., R.K.P.).'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland (T.Q., D.J.S.).'}, {'ForeName': 'Torquil', 'Initials': 'T', 'LastName': 'Watt', 'Affiliation': 'Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Copenhagen University Hospital Herlev, Herlev, Denmark, and University of Copenhagen, Copenhagen, Denmark (T.W., R.W.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Inselspital, Bern University Hospital, and Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland (M.D., M.F., S.B., N.R.).'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark; and University of California, San Francisco, San Francisco, California (D.C.B.).'}]",Annals of internal medicine,['10.7326/M19-3193']
27,32365359,"Rifabutin-Based Triple Therapy (RHB-105) for  Helicobacter pylori  Eradication: A Double-Blind, Randomized, Controlled Trial.","BACKGROUND


Although consensus supports eradication of  Helicobacter pylori  infections, antimicrobial resistance has substantially reduced eradication rates with most current therapies.
OBJECTIVE


To assess the effectiveness of a novel rifabutin-based therapy (RHB-105) for  H pylori  eradication.
DESIGN


Phase 3, double-blind trial (ERADICATE Hp2). (ClinicalTrials.gov: NCT03198507).
SETTING


55 clinical research sites in the United States.
PARTICIPANTS


455 treatment-naive adults with epigastric discomfort and confirmed  H pylori  infection.
INTERVENTION


RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole, 120 mg), given as 4 capsules every 8 hours for 14 days.
MEASUREMENTS


Between-group difference for  H pylori  eradication rate, demonstrated by  13 C urea breath test 4 weeks after treatment, analyzed by using the χ 2  test.
RESULTS


In the intention-to-treat population, the eradication rate was higher with RHB-105 than with the active comparator (228 vs. 227 patients, respectively; 83.8% [95% CI, 78.4% to 88.0%] vs. 57.7% [95% CI, 51.2% to 64.0%];  P  < 0.001). Eradication rates were unaffected by resistance to clarithromycin or metronidazole. No rifabutin resistance was detected. The most commonly reported adverse events (incidence ≥5%) were diarrhea (10.1% with RHB-105 vs. 7.9% with active comparator), headache (7.5% vs. 7.0%), and nausea (4.8% vs. 5.3%).
LIMITATION


Persons of Asian descent were excluded because of their higher prevalence of poor cytochrome P450 2C19 metabolizers.
CONCLUSION


These findings suggest potential for RHB-105 as first-line empirical  H pylori  therapy, addressing an unmet need in the current environment of increasing antibiotic resistance.
PRIMARY FUNDING SOURCE


RedHill Biopharma Ltd.",2020,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"['Participants\n\n\n455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection', 'Helicobacter pylori Eradication', 'Limitation\n\n\nPersons of Asian descent']","['novel rifabutin-based therapy (RHB-105', 'RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole', 'Rifabutin-Based Triple Therapy (RHB-105', 'metronidazole', 'clarithromycin']","['headache', 'diarrhea', 'rifabutin resistance', 'eradication rate', 'Eradication rates', 'adverse events', 'nausea', 'eradication rates', 'H pylori eradication rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",455.0,0.422929,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"[{'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Graham', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Yamil', 'Initials': 'Y', 'LastName': 'Canaan', 'Affiliation': 'Jesscan Medical Research, Miami, Florida (Y.C.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maher', 'Affiliation': 'BI Research Center, Houston, Texas (J.M.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wiener', 'Affiliation': 'GW Research, Inc., Chula Vista, California (G.W.).'}, {'ForeName': 'Kristina G', 'Initials': 'KG', 'LastName': 'Hulten', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'Independent Consultant to Pharmaceutical companies, New York, New York (I.N.K.).'}]",Annals of internal medicine,['10.7326/M19-3734']
28,32366163,Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial.,"Background Trimethylamine N-oxide (TMAO) may have prothrombotic properties. We examined the association of TMAO quartiles with major adverse cardiovascular events (MACE) and the effect of TMAO on the efficacy of ticagrelor. Methods and Results PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin - Thrombolysis in Myocardial Infarction 54) randomized patients with prior myocardial infarction to ticagrelor or placebo (median follow-up 33 months). Baseline plasma concentrations of TMAO were measured in a nested case-control study of 597 cases with cardiovascular death, myocardial infarction, or stroke (MACE) and 1206 controls matched for age, sex, and estimated glomerular filtration rate [eGFR]. Odds ratios (OR) were used for the association between TMAO quartiles and MACE, adjusting for baseline clinical characteristics (age, sex, eGFR, region, body mass index, hypertension, hypercholesterolemia, diabetes mellitus, smoking, peripheral artery disease, index event, aspirin dosage and treatment arm), and cardiovascular biomarkers (hs-TnT [high-sensitivity troponin T], hs-CRP [high-sensitivity C-reactive protein], NT-proBNP [N-terminal-pro-B-type natriuretic peptide]). Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93,  P  trend=0.015). The association was driven by cardiovascular death (OR 2.25, 95% CI, 1.28-3.96,  P  trend=0.003) and stroke (OR 2.68, 95% CI, 1.39-5.17,  P  trend<0.001). After adjustment for clinical factors, the association persisted for cardiovascular death (OR adj  1.89, 95% CI, 1.03-3.45,  P  trend=0.027) and stroke (OR adj  2.01, 95% CI, 1.01-4.01,  P  trend=0.022), but was slightly attenuated after adjustment for cardiovascular biomarkers (cardiovascular death: OR adj  1.74, 95% CI, 0.88-3.45,  P  trend=0.079; and stroke: OR adj  1.82, 95% CI, 0.88-3.78,  P  trend=0.056). The reduction in MACE with ticagrelor was consistent across TMAO quartiles ( P  interaction=0.92). Conclusions Among patients with prior myocardial infarction, higher TMAO levels were associated with cardiovascular death and stroke but not with recurrent myocardial infarction. The efficacy of ticagrelor was consistent regardless of TMAO levels. Registration URL: https://www.clini​caltr​ials.gov; Unique identifiers: PEGASUS-TIMI 54, NCT01225562.",2020,"Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93,  P  trend=0.015).","['Myocardial Infarction 54) randomized patients with prior myocardial infarction to', 'Patients With Prior Heart Attack Using', 'Patients', 'patients with prior myocardial infarction', 'With Prior Myocardial Infarction', '597 cases with cardiovascular death, myocardial infarction, or stroke (MACE) and 1206 controls matched for age, sex, and estimated glomerular filtration rate [eGFR']","['Ticagrelor', 'Placebo', ' Trimethylamine N-oxide (TMAO', 'ticagrelor or placebo', 'TMAO', 'Aspirin - Thrombolysis', 'ticagrelor']","['Baseline plasma concentrations of TMAO', 'cardiovascular death and stroke', 'Odds ratios (OR', 'cardiovascular death', 'Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes', 'stroke', 'TMAO levels', 'Higher TMAO quartiles', 'TMAO quartiles with major adverse cardiovascular events (MACE']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",597.0,0.189664,"Higher TMAO quartiles were associated with risk of MACE (OR for quartile 4 versus quartile 1, 1.43, 95% CI, 1.06-1.93,  P  trend=0.015).","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Xinmin S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research Division of Cardiovascular Medicine University of Colorado Denver CO.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center Rutgers-New Jersey Medical School Newark NJ.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat Paris France.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Cardiovascular Research Unit Department of Infection, Immunity and Cardiovascular Disease University of Sheffield United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Göteborg Sweden.'}, {'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cardiovascular and Metabolic Sciences Lerner Research Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.015331']
29,32366308,A stepped wedge trial of efficacy and scalability of a virtual clinical pharmacy service (VCPS) in rural and remote NSW health facilities.,"BACKGROUND


Medication errors are a leading cause of mortality and morbidity. Clinical pharmacy services provided in hospital can reduce medication errors and medication related harm. However, few rural or remote hospitals in Australia have a clinical pharmacy service. This study will evaluate a virtual clinical pharmacy service (VCPS) provided via telehealth to eight rural and remote hospitals in NSW, Australia.
METHODS


A stepped wedge cluster randomised trial design will use routinely collected data from patients' electronic medical records (n = 2080) to evaluate the VCPS at eight facilities. The sequence of steps is randomised, allowing for control of potential confounding temporal trends. Primary outcomes are number of medication reconciliations completed on admission and discharge. Secondary outcomes are length of stay, falls and 28 day readmissions. A cost-effectiveness analysis (CEA) and cost-benefit analysis (CBA) will be conducted. The CEA will answer the question of whether the VCPS is more cost-effective compared to treatment as usual; the CBA will consider the rate of return on investing in the VCPS. A patient experience measure (n = 500) and medication adherence questionnaire (n = 100 pre and post) will also be used to identify patient responses to the virtual service. Focus groups will investigate implementation from hospital staff perspectives at each site. Analyses of routine data will comprise generalised linear mixed models. Descriptive statistical analysis will summarise patient experience responses. Differences in medication adherence will be compared using linear regression models. Thematic analysis of focus groups will identify barriers and facilitators to VCPS implementation.
DISCUSSION


We aim to demonstrate the effectiveness of virtual pharmacy interventions for rural populations, and inform best practice for using virtual healthcare to improve access to pharmacy services. It is widely recognised that clinical pharmacists are best placed to reduce medication errors. However, pharmacy services are limited in rural and remote hospitals. This project will provide evidence about ways in which the benefits of hospital pharmacists can be maximised utilising telehealth technology. If successful, this project can provide a model for pharmacy delivery in rural and remote locations.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) -ACTRN12619001757101 Prospectively registered on 11 December 2019. Record available from: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378878&isReview=true.",2020,This project will provide evidence about ways in which the benefits of hospital pharmacists can be maximised utilising telehealth technology.,"['eight rural and remote hospitals in NSW, Australia', ""patients' electronic medical records (n\u2009=\u20092080) to evaluate the VCPS at eight facilities"", 'Prospectively registered on 11 December 2019', 'rural and remote NSW health facilities']","['virtual pharmacy interventions', 'https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378878&isReview=true', 'virtual clinical pharmacy service (VCPS', 'VCPS']","['medication adherence questionnaire', 'medication adherence', 'length of stay, falls and 28\u2009day readmissions', 'number of medication reconciliations completed on admission and discharge']","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0008968', 'cui_str': 'Clinical Pharmacy Service'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008968', 'cui_str': 'Clinical Pharmacy Service'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.209652,This project will provide evidence about ways in which the benefits of hospital pharmacists can be maximised utilising telehealth technology.,"[{'ForeName': 'Julaine', 'Initials': 'J', 'LastName': 'Allan', 'Affiliation': 'School of Health and Society, University of Wollongong, Wollongong, Australia. julaineallan@gmail.com.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Nott', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Chambers', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Ged', 'Initials': 'G', 'LastName': 'Hawthorn', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Munro', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Doran', 'Affiliation': 'Central Queensland University, Brisbane, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, Newcastle, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Coleman', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Teesta', 'Initials': 'T', 'LastName': 'Saksena', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}]",BMC health services research,['10.1186/s12913-020-05229-y']
30,32365431,Bronchial thermoplasty versus mepolizumab: Comparison of outcomes in a severe asthma clinic.,"BACKGROUND AND OBJECTIVE


BT and interleukin-blocking monoclonal antibodies are both effective therapies for severe asthma, but there have been no direct comparisons between the two treatments. The aim of this study was to compare the efficacy and safety of BT and mepolizumab, in a real-world setting.
METHODS


Patients with severe asthma despite optimized inhaler therapy were drawn from a severe asthma clinic in a tertiary hospital. Every patient commencing therapy with BT or mepolizumab was prospectively included in a national registry. At predetermined assessment points over a 12-month period, assessments were made of ACQ, spirometry, oral corticosteroid requiring exacerbations, reliever medication and maintenance oral corticosteroid use.
RESULTS


A total of 91 patients with severe asthma participated: mean ACQ score 3.5 ± 1.0, FEV 1  51.4 ± 17.7%, maintenance oral steroids 48.3% and 11.5 ± 10.0 inhalations/day reliever therapy. Forty-seven patients received mepolizumab and 44 received BT. Baseline characteristics were similar except significantly higher blood eosinophil count in the mepolizumab group. At 12 months, there were no differences between treatment outcomes for ACQ (1.9 ± 1.3 mepolizumab vs 1.7 ± 1.3 BT), exacerbation rate (0.9 ± 1.1 vs 0.9 ± 1.5), reduction in reliever use (-6.3 ± 10.5 vs -5.0 ± 8.8 puffs/day) or reduction in oral corticosteroids (-3.3 ± 7.5 vs - 5.8 ± 6.7 mg/day). The FEV 1  improved equally (160 ± 290 vs 150 ± 460 mL). Readmission or prolonged admission was observed in 18.2% of BT patients, whilst 25.5% of mepolizumab patients had discontinued treatment at 12 months, 14.9% due to an adverse event or non-compliance.
CONCLUSION


The results suggest that BT is as efficacious as mepolizumab for the treatment of severe asthma.",2020,"mean ACQ score 3.5 ± 1.0, FEV 1  51.4 ± 17.7%, maintenance oral steroids 48.3% and 11.5 ± 10.0 inhalations/day reliever therapy.","['severe asthma clinic', 'Patients with severe asthma despite optimized inhaler therapy were drawn from a severe asthma clinic in a tertiary hospital', '91 patients with severe asthma participated']","['Bronchial thermoplasty versus mepolizumab', 'BT', 'BT or mepolizumab', 'mepolizumab and 44 received BT', 'BT and mepolizumab']","['blood eosinophil count', 'reduction in reliever use', 'efficacy and safety', 'ACQ, spirometry, oral corticosteroid requiring exacerbations, reliever medication and maintenance oral corticosteroid use', 'exacerbation rate', 'Readmission or prolonged admission']","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",91.0,0.202776,"mean ACQ score 3.5 ± 1.0, FEV 1  51.4 ± 17.7%, maintenance oral steroids 48.3% and 11.5 ± 10.0 inhalations/day reliever therapy.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Langton', 'Affiliation': 'Department of Thoracic Medicine, Frankston Hospital, Peninsula Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Sha', 'Affiliation': 'Department of Thoracic Medicine, Frankston Hospital, Peninsula Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Suzy', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Department of Thoracic Medicine, Frankston Hospital, Peninsula Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Sharp', 'Affiliation': 'Department of Thoracic Medicine, Frankston Hospital, Peninsula Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Department of Thoracic Medicine, Frankston Hospital, Peninsula Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Plummer', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Thien', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13830']
31,32366124,"Waiting for speech-language pathology services: A randomised controlled trial comparing therapy, advice and device.","Purpose:  To compare children's speech, language and early literacy outcomes, and caregivers' empowerment and satisfaction following provision of 12 sessions of direct intervention (therapy), or face-to-face advice or a purpose-built website (device) while waiting for therapy. Method:  A four-stage randomised controlled trial was undertaken involving three- to six-year-old children referred to speech-language pathology waiting lists at two Australian community health centres over eight months ( n  = 222). Stage 1 (screening): 149 were eligible to participate. Stage 2 (pre-assessment): 117 were assessed. Stage 3 (intervention): 110 were randomised to advice (33), device (39) or therapy (38). Stage 4 (post-assessment): 101 were re-assessed by a speech-language pathologist blinded to the intervention condition. Result:  After controlling for baseline levels, children's speech (percentage of consonants correct) was significantly higher in the therapy group compared to the advice and device conditions. Caregivers' satisfaction was also significantly higher in the therapy condition compared to the device condition. There were no significant differences between the three conditions for children's intelligibility, language and early literacy or caregivers' empowerment. Conclusion:  Therapy resulted in significantly higher speech outcomes than the advice and device conditions and was associated with significantly greater caregiver satisfaction. Provision of a website containing evidence-based material or a single session of advice may be a viable alternative while children wait for therapy targeting intelligibility, language and early literacy, and to empower caregivers.",2020,"There were no significant differences between the three conditions for children's intelligibility, language and early literacy or caregivers' empowerment.","['six-year-old children referred to speech-language pathology waiting lists at two Australian community health centres over eight months ( n \u2009=\u2009222', '149 were eligible to participate', 'Stage 1 (screening', 'Stage 3 (intervention', 'Waiting for speech-language pathology services']","['direct intervention (therapy), or face-to-face advice or a purpose-built website (device) while waiting for therapy']","['speech outcomes', ""children's intelligibility, language and early literacy or caregivers' empowerment"", ""Caregivers' satisfaction"", 'caregiver satisfaction', ""children's speech, language and early literacy outcomes""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037825', 'cui_str': 'Pathology, Speech-Language'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}]",,0.116638,"There were no significant differences between the three conditions for children's intelligibility, language and early literacy or caregivers' empowerment.","[{'ForeName': 'Sharynne', 'Initials': 'S', 'LastName': 'McLeod', 'Affiliation': 'School of Teacher Education, Charles Sturt University, Bathurst, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'Western NSW Local Health District, Bathurst, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Rohr', 'Affiliation': 'Western NSW Local Health District, Bathurst, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'McGill', 'Affiliation': 'School of Teacher Education, Charles Sturt University, Bathurst, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Western NSW Local Health District, Bathurst, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Thornton', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ahio', 'Affiliation': 'Western NSW Local Health District, Dubbo, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ivory', 'Affiliation': 'Faculty of Arts and Education, Charles Sturt University, Albury, Australia.'}]",International journal of speech-language pathology,['10.1080/17549507.2020.1731600']
32,32362552,"Comparing the Efficacy of Bevacizumab and Ranibizumab in Patients with Diabetic Macular Edema (BRDME): The BRDME Study, a Randomized Trial.","PURPOSE


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


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


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


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


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


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


Based on change in BCVA from baseline to month 6, the noninferiority of 1.25 mg bevacizumab to 0.5 mg ranibizumab was not confirmed. Only the subgroup of patients with a lower BCVA at baseline showed better visual acuity and anatomic outcomes with ranibizumab. Our study confirmed the potential differential efficacy of anti-vascular endothelial growth factor agents in the treatment of DME as well as the difference in response between patient groups with different baseline visual acuities.",2020,Central area thickness decreased more with ranibizumab (138.2±114.3 μm) compared with bevacizumab (64.2±104.2 μm).,"['From June 2012 through February 2018, a total of 170 participants', 'patients with diabetic macular edema (DME', 'Patients with Diabetic Macular Edema (BRDME', 'Eligible patients were older than 18 years, diagnosed with type 1 or type 2 diabetes mellitus, with glycosylated hemoglobin of less than 12%, central area thickness of more than 325 μm, and visual impairment from DME with a best-corrected visual acuity (BCVA) between 24 letters and 78 letters']","['anti-vascular endothelial growth factor agents', 'Bevacizumab and\xa0Ranibizumab', 'ranibizumab', 'bevacizumab']","['mean BCVA', 'central area thickness', 'change in BCVA', 'visual acuity and anatomic outcomes', 'BCVA or OCT outcomes', 'Central area thickness', 'BCVA']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",170.0,0.494608,Central area thickness decreased more with ranibizumab (138.2±114.3 μm) compared with bevacizumab (64.2±104.2 μm).,"[{'ForeName': 'Maartje J C', 'Initials': 'MJC', 'LastName': 'Vader', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ann-Sofie M E', 'Initials': 'AME', 'LastName': 'Schauwvlieghe', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Verbraak', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Greetje', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johanna M M', 'Initials': 'JMM', 'LastName': 'Hooymans', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Leonoor I', 'Initials': 'LI', 'LastName': 'Los', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen and W. J. Kolff Institute, Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Aeilko H', 'Initials': 'AH', 'LastName': 'Zwinderman', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Department of Ophthalmology, Queens University Belfast, Belfast, United Kingdom.'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Vingerling', 'Affiliation': 'Department of Ophthalmology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette C', 'Initials': 'AC', 'LastName': 'Moll', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke J C', 'Initials': 'JJC', 'LastName': 'van Lith-Verhoeven', 'Affiliation': 'Department of Ophthalmology, Elisabeth-TweeSteden (ETZ) Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Reinier O', 'Initials': 'RO', 'LastName': 'Schlingemann', 'Affiliation': 'Department of Ophthalmology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Ophthalmology, University of Lausanne, Jules-Gonin Eye Hospital, Lausanne, Switzerland. Electronic address: r.o.schlingemann@amsterdamumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.008']
33,32361032,Ethnicity moderates outcome in family focused treatment for pediatric obsessive compulsive disorder.,"OBJECTIVE


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


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


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


Minority status predicts poorer response to standard CBT across disorders, suggesting the need for possible treatment adaptations. The present findings highlight one avenue for matching patients to treatments that might optimize outcomes and underscore the value of family involvement in OCD treatment.",2020,"There were no predictors of treatment outcome.
","['pediatric obsessive compulsive disorder', '62 youths (Mean age\u2009=\u200912.71 years; 57 % male; 34 % non-white']",['standard cognitive behavioral therapy (CBT) family intervention (ST) or to a tailored intervention designed for cases of OCD complicated by poor family functioning (Enhanced Family Therapy; ET'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0015618', 'cui_str': 'Family therapy'}]",[],62.0,0.0176714,"There were no predictors of treatment outcome.
","[{'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Peris', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States. Electronic address: tperis@mednet.ucla.edu.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, United States.'}, {'ForeName': 'Sunhye', 'Initials': 'S', 'LastName': 'Bai', 'Affiliation': 'Pennsylvania State University, United States.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}, {'ForeName': 'Hardian', 'Initials': 'H', 'LastName': 'Thamrin', 'Affiliation': 'University of Arizona, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Jane and Semel Institute for Neuroscience and Human Behavior, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102229']
34,32359843,Long-term Visual Outcomes after Release from Protocol in Patients who Participated in the Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) Trial.,"PURPOSE


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


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


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


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


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


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


Approximately 5 years after the IVAN study finished, with unprecedented completeness of follow-up for such a trial, the trajectory of functional decline in the study eye was shown to be greater than that previously reported for incomplete trial cohorts. Anti-VEGF injection rates and treatment switches were not important factors in determining visual acuity outcomes.",2020,"Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year.","['participants who switched or did not switch at the end of study monitoring', 'Patients who Participated in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) Trial', 'Multicenter cohort study up to 7 years after trial exit', 'Data were collected between May 26, 2016, and August 24, 2017', 'Patients enrolled in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial; after excluding participants from 2 sites and who died or withdrew during the trial, 537 were included in this follow-up cohort', 'participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD']","['bevacizumab or ranibizumab', 'ranibizumab', 'aflibercept']","['Distance visual acuity (DVA) (letters read', 'rate of change in DVA', 'visit and treatment frequency and switches in anti-vascular endothelial growth factor (VEGF) drug', 'median duration of study eye monitoring after IVAN exit', 'visual acuity outcomes', 'Rate of change of DVA during active surveillance of the study eye (study eye monitoring', 'Injection rate', 'median DVA']","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1283169', 'cui_str': 'Monitoring - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",537.0,0.324775,"Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year.","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Katherine Alyson', 'Initials': 'KA', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland. Electronic address: u.chakravarthy@qub.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.020']
35,32360256,Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Cardiogenic Shock.,"OBJECTIVES


This study sought to compare outcomes of patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI).
BACKGROUND


In patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS), intervening on the nonculprit vessel is controversial. There are conflicting published reports and lack of evidence, particularly in patients treated with early mechanical circulatory support (MCS).
METHODS


From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals were included in this analysis. All patients were treated using a standard shock protocol emphasizing early MCS, revascularization, and invasive hemodynamic monitoring. Patients with multivessel coronary artery disease (MVCAD) were analyzed according to whether CV-PCI or MV-PCI was undertaken during the index procedure.
RESULTS


Of 198 patients with MVCAD, 126 underwent MV-PCI (64%) and 72 underwent CV-PCI (36%). Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction. Patients who underwent MV-PCI had a trend toward more severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance was significantly worse at 12 h. However, 24 h from PCI, the hemometabolic derangements were similar. Survival and rates of acute kidney injury were not significantly different between groups (69.8% MV-PCI vs. 65.3% CV-PCI; p = 0.51; and 29.9% vs. 34.2%; p = 0.64, respectively).
CONCLUSIONS


In patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions was associated with similar hospital survival and acute kidney injury when compared with culprit-only PCI. Selective nonculprit PCI can be safety performed in AMICS in patients supported with mechanical circulatory support.",2020,"Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction.","['patients enrolled in the NCSI (National Cardiogenic Shock Initiative) trial who were treated using a revascularization strategy of', 'patients with MVCAD presenting with AMICS treated with early MCS, revascularization of nonculprit lesions', 'patients supported with mechanical circulatory support', 'Cardiogenic Shock', '198 patients with MVCAD', 'patients with multivessel disease who present with acute myocardial infarction and cardiogenic shock (AMICS', 'Patients with multivessel coronary artery disease (MVCAD', 'patients treated with early mechanical circulatory support (MCS', 'From July 2016 to December 2019, patients who presented with AMICS to 57 participating hospitals']","['Culprit-Vessel Percutaneous\xa0Coronary Intervention', 'percutaneous coronary intervention (PCI) of multivessel PCI (MV-PCI) versus culprit-vessel PCI (CV-PCI', 'Multi']","['Survival and rates of acute kidney injury', 'hospital survival and acute kidney injury', 'severe impairment of cardiac output and worse lactate clearance on presentation, and cardiac performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",198.0,0.0717317,"Demographics between the cohorts were similar with respect to age, sex, history of diabetes, prior PCI or coronary artery bypass grafting, and prior history of myocardial infarction.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lemor', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan. Electronic address: alejandrolemor@outlook.com.'}, {'ForeName': 'Mir B', 'Initials': 'MB', 'LastName': 'Basir', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Kirit', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, St. Joseph Mercy Oakland, Pontiac, Michigan.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kolski', 'Affiliation': ""Department of Cardiology, St. Joseph's Hospital-Orange, Orange, California.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kaki', 'Affiliation': 'Department of Cardiology, Ascension St. John Hospital-Detroit, Detroit, Michigan.'}, {'ForeName': 'Navin K', 'Initials': 'NK', 'LastName': 'Kapur', 'Affiliation': 'Department of Cardiology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riley', 'Affiliation': 'The Christ Hospital Health Network, Cincinnati Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Finley', 'Affiliation': 'Department of Cardiology, Mercy Fitzgerald Hospital, Yeadon, Pennsylvania.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goldsweig', 'Affiliation': 'Department of Cardiology, University of Nebraska, Omaha, Nebraska.'}, {'ForeName': 'Herbert D', 'Initials': 'HD', 'LastName': 'Aronow', 'Affiliation': 'Department of Cardiology, Alpert Medical School at Brown University, Providence, Rhode Island.'}, {'ForeName': 'P Matthew', 'Initials': 'PM', 'LastName': 'Belford', 'Affiliation': 'Department of Cardiology, Wake Forest Baptist Health, Winston-Salem, North Carolina.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Tehrani', 'Affiliation': 'Department of Cardiology, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Truesdell', 'Affiliation': 'Department of Cardiology, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lasorda', 'Affiliation': 'Department of Cardiology, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Cardiology, Loma Linda Medical Center, Loma Linda, California.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Hanson', 'Affiliation': 'Department of Cardiology, Beaumont Hospital-Royal Oak, Royal Oak, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'LaLonde', 'Affiliation': 'Department of Cardiology, Ascension St. John Hospital-Detroit, Detroit, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gorgis', 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Cardiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.03.012']
36,32305380,Six-year results of a randomized controlled clinical trial of two glass ionomer cements in class II cavities.,"OBJECTIVES


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


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


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


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


Highly viscous glass ionomer cement can be an acceptable restoration material for smaller class II cavities.",2020,The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907).,['two glass ionomer cements in class II cavities'],[],['survival rates'],"[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0247799,The Kaplan-Meier survival proportion for Equia Fil restorations at 6 years was 86.5% and that for Fuji IX GP Fast at 6 years was 86.8% (log-rank p = 0.907).,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Heck', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany. Electronic address: kheck@dent.med.uni-muenchen.de.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Frasheri', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Diegritz', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Manhart', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hickel', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fotiadou', 'Affiliation': 'Department of Conservative Dentistry and Periodontology, University Hospital, Ludwig-Maximilians-University Munich, Goethestr. 70, 80336 Munich, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103333']
37,32369436,Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT.,"BACKGROUND


Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection.
OBJECTIVE


To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers.
DESIGN


This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target sample size was 500 patients. A web-based randomisation system was used to allocate treatments.
SETTING


Twenty-seven NHS hospitals (68 surgeons).
PARTICIPANTS


Patients with medial compartment knee osteoarthritis.
INTERVENTIONS


The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated.
MAIN OUTCOME MEASURES


The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed.
RESULTS


A total of 528 patients were randomised (partial knee replacement,  n  = 264; total knee replacement,  n  = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval -0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) ( n  = 233), mean 35.1 (standard deviation 9.1) ( n  = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 'failures' of partial knee replacement and 38 'failures' of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use.
LIMITATIONS


It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure.
CONCLUSIONS


Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years.
FUTURE WORK


Further (10-year) follow-up is in progress to assess the longer-term stability of these findings.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 20. See the NIHR Journals Library website for further project information.",2020,"Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates.","['Patients with medial compartment knee osteoarthritis', '528 patients were randomised (partial knee replacement,  n \u2009=\u2009264; total knee replacement,  n \u2009=\u2009264', 'Twenty-seven NHS hospitals (68 surgeons', 'patients with medial compartment knee osteoarthritis']","['partial knee replacement treatment with total knee replacement treatment', 'total knee replacement or partial (unicompartmental) knee replacement', 'partial knee replacement', 'total knee replacement', 'Partial knee replacement']","['Cost-effectiveness', 'health benefits', ""activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation"", 'clinical effectiveness and cost-effectiveness', 'frequency of reoperation (including revision', 'mean Oxford Knee Score', 'Revision rates', 'health-care costs, reflecting lower costs of the index surgery and subsequent health-care use', 'cost-effective (more effective and cost saving', 'patterns of benefit in the direction of partial knee replacement compared with total knee replacement', 'response rate', ""failures' of partial knee replacement and 38 'failures' of total knee replacement""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0447798', 'cui_str': 'Compartment of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",528.0,0.0963477,"Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Loretta J', 'Initials': 'LJ', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kent', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Public Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Murray', 'Affiliation': 'Nuffield Department of Orthopaedics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marion K', 'Initials': 'MK', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24200']
38,32370588,Comprehensive Management With the ABC (Atrial Fibrillation Better Care) Pathway in Clinically Complex Patients With Atrial Fibrillation: A Post Hoc Ancillary Analysis From the AFFIRM Trial.,"Background For patients with atrial fibrillation, a comprehensive care approach based on the Atrial fibrillation Better Care (ABC) pathway can reduce the occurrence of adverse outcomes. The aim of this paper was to investigate if an approach based on the ABC pathway is associated with a reduced risk of adverse events in ""clinically complex"" atrial fibrillation patients, including those with multiple comorbidities, polypharmacy, and prior hospitalizations. Methods and Results We performed a post hoc analysis of the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial. The principal outcome was the composite of all-cause hospitalization and all-cause death. An integrated care approach (ABC group) was used in 3.8% of the multimorbidity group, 4.0% of the polypharmacy group, and 4.8%, of the hospitalized groups. In all ""clinically complex"" groups, the cumulative risk of the composite outcome was significantly lower in patients managed consistent with the ABC pathway versus non-ABC pathway-adherent (all  P <0.05). Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups. Secondary analyses showed that the higher number of ABC criteria fulfilled the larger associated reduction in relative risk, even for secondary outcomes considered. Conclusions Use of an ABC consistent pathway is associated with fewer major adverse events in patients with atrial fibrillation who have multiple comorbidities, use of polypharmacy, and prior hospitalization.",2020,"Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups.","['Atrial Fibrillation Better Care', 'patients with atrial fibrillation who have multiple comorbidities, use of polypharmacy, and prior hospitalization', 'patients with atrial fibrillation', 'Clinically Complex Patients With Atrial Fibrillation', 'clinically complex"" atrial fibrillation patients']",['ABC'],"['cumulative risk of the composite outcome', 'composite of all-cause hospitalization and all-cause death']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0434019,"Cox regression analysis showed a reduction of composite outcomes in ABC pathway-adherent versus non-ABC pathway-adherent for multimorbidity (hazard ratio [HR], 0.61, 95% CI, 0.44-0.85), polypharmacy (HR, 0.68, 95% CI, 0.47-1.00), and hospitalization (HR, 0.59, 95% CI, 0.42-0.85) groups.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Proietti', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}, {'ForeName': 'Giulio Francesco', 'Initials': 'GF', 'LastName': 'Romiti', 'Affiliation': 'Department of Internal Medicine and Medical Specialties Sapienza-University of Rome Italy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Olshansky', 'Affiliation': 'Division of Cardiovascular Medicine University of Iowa Hospitals and Clinics Iowa City IA.'}, {'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Lane', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014932']
39,32391709,"Single-session digital intervention for adolescent depression, anxiety, and well-being: Outcomes of a randomized controlled trial with Kenyan adolescents.","BACKGROUND


Adolescent depression and anxiety symptoms are prevalent in sub-Saharan African countries, yet treatment options are scarce, and stigma limits help-seeking. Brief, computerized single-session interventions (SSIs) that contain empirically supported stigma-reducing elements may help expand access to treatment. We developed and evaluated such an intervention for Kenyan adolescents.
METHOD


High school students (N = 103, age 13-18) were randomized to a digital SSI Shamiri-Digital (Shamiri means ""thrive"" in Kiswahili) or a study-skills control intervention. Shamiri-Digital consisted of reading and writing activities about 3 concepts: growth mindset, gratitude, and value affirmation. Both Shamiri-Digital and the study-skills control condition were delivered electronically in schools.
RESULTS


Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up. The effects exceed the mean effects reported in meta-analyses of full-length, face-to-face psychotherapy for youth depression. There were no significant effects on anxiety symptoms, well-being, or happiness.
CONCLUSION


This is the first report that a brief, computerized SSI may reduce depressive symptoms in adolescents in sub-Saharan Africa. Replication trials with extended follow-ups will help gauge the strength and durability of these effects. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","['Kenyan adolescents', 'High school students (N = 103, age 13-18', 'adolescents in sub-Saharan Africa']","['computerized SSI', 'digital SSI Shamiri-Digital (Shamiri means ""thrive"" in Kiswahili) or a study-skills control intervention', 'Single-session digital intervention', 'computerized single-session interventions (SSIs']","['severe depression symptoms', 'anxiety symptoms, well-being, or happiness', 'depressive symptoms', 'adolescent depressive symptoms']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",,0.0872907,"Compared to the control, Shamiri-Digital produced a greater reduction in adolescent depressive symptoms in both the full sample (p = .028, d = 0.50) and a subsample of youths with moderate to severe depression symptoms (p = .010, d = 0.83) from baseline to 2-week follow-up.","[{'ForeName': 'Tom L', 'Initials': 'TL', 'LastName': 'Osborn', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, University of Pennsylvania.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Rediet G', 'Initials': 'RG', 'LastName': 'Alemu', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Roe', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Arango G', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Benny H', 'Initials': 'BH', 'LastName': 'Otieno', 'Affiliation': 'Shamiri Institute.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wasanga', 'Affiliation': 'Department of Psychology, Kenyatta University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shingleton', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000505']
40,32375763,ReNaApp: increasing the long-term effects of oncological rehabilitation through an application after medical rehabilitation (ReNaApp): a quasi-randomized longitudinal study of prospective design.,"BACKGROUND


Breast cancer is the most common malignant disease in women. Compared with other cancer types, breast cancer has a higher survival rate. The majority of breast cancer patients are overstrained to implement cancer-specific recommendations relating to changes in health behaviour. Numerous epidemiological studies have shown a positive correlation between physical activity and quality of life as well as the course of disease during and after breast cancer treatment. However, many patients have difficulties integrating physical activity into their everyday lives due to cancer symptoms. To develop physical activity into a daily routine, an aftercare programme for breast cancer patients will be developed. In particular, the programme is structured in terms of the validated concept ""Neues Credo"". The basic concept is converted into a mobile application.
METHODS


The study sample includes n = 740 rehabilitants (370 for the intervention group and for the control group) from five different rehab clinics in Northern Germany. The evaluation is as follows: a) Quasi-randomized, prospective longitudinal study (sequential study design). The intervention group receives a mobile application after rehabilitation, and the control group receives treatment as usual. The study evaluation is carried out through a questionnaire at three stages (at the beginning of the rehabilitation, at the end of the rehabilitation, and after 12 months). b) Qualitative analysis of interviews and focus groups in terms of feasibility and acceptance. c) Formative evaluation of the app.
DISCUSSION


Above all, the aftercare programme ReNaApp increases the long-term effects of oncological rehabilitation. By documenting physical activity in ReNaApp, rehabilitants become more motivated to engage in physical activity in their everyday lives. Currently, there is no scientifically evaluated app for breast cancer patients in the German language. Thus, ReNaApp ensures an aftercare treatment for breast cancer patients with high-quality performance regardless of their place of residence. By adopting a participatory approach and a user-centred design, ReNaApp corresponds to the demands of the rehabilitants.
TRIAL REGISTRATION


German Register of Clinical Trials, www.drks.de. Identifier: DRKS00019017; Registered: November 7th, 2019. Date and version identifier: April 17th 2020; vesion 2.",2020,"By adopting a participatory approach and a user-centred design, ReNaApp corresponds to the demands of the rehabilitants.
","['breast cancer patients in the German language', 'women', 'breast cancer patients with high-quality performance regardless of their place of residence', 'breast cancer patients', 'The study sample includes n\u2009=\u2009740 rehabilitants (370 for the intervention group and for the control group) from five different rehab clinics in Northern Germany']","['oncological rehabilitation', 'mobile application after rehabilitation, and the control group receives treatment as usual', 'medical rehabilitation (ReNaApp', 'ReNaApp']","['survival rate', 'physical activity and quality of life']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0209602,"By adopting a participatory approach and a user-centred design, ReNaApp corresponds to the demands of the rehabilitants.
","[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rutsch', 'Affiliation': 'Institute for Social Medicine and Epidemiology, Department Rehabilitation Sciences, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. mercedes.rutsch@uksh.de.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jochems', 'Affiliation': 'Institute for Multimedia and Interactive Systems, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schrader', 'Affiliation': 'Institute of Telematics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Brandes', 'Affiliation': 'Institute for Epidemiology, Department Rehabilitation Sciences, Social Medicine and Health System Research, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Weier', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Deck', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany.'}]",BMC health services research,['10.1186/s12913-020-05248-9']
41,32386466,Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial.,"INTRODUCTION


Chronic pelvic pain in women is a complex condition, and physical therapy is recommended as part of a broader treatment approach. The objective of this study was to compare structured group-based multimodal physical therapy in a hospital setting (intervention group) with primary-care physical therapy (comparator group) for women with chronic pelvic pain.
MATERIAL AND METHODS


Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible. The primary outcome measure was change in the mean pelvic pain intensity from baseline to 12 months, measured using the numeric rating scale (0-10). Secondary outcomes were changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation. The differences between the groups regarding change in scores were analyzed using the independent t test and Mann-Whitney U test. Sensitivity analysis of the primary outcome was performed with a linear regression model adjusted for the baseline value. A P value <.05 was considered statistically significant.
RESULTS


Of the 62 women included, 26 in the intervention group and 25 in the comparator group were available after 12 months for data collection and analysis. The difference between the groups for change in the mean pain intensity score was -1.2 (95% CI -2.3 to -0.2; P = .027), favoring the intervention group. The intervention group showed greater improvements in respiratory patterns (mean difference 0.9; 95% CI 0.2-1.6; P = .015) and pain-related fear of movements (mean difference 2.9; 95% CI -5.5 to -0.3; P = .032), and no significant differences were observed between the groups for the other secondary outcomes.
CONCLUSIONS


Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary-care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.",2020,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","['women with chronic pelvic pain', 'Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible']","['multimodal physical therapy', 'primary care physical therapy (comparator group', 'structured group-based multimodal physical therapy']","['mean pain intensity score', 'respiratory patterns', 'pain-related fear of movements', 'numeric rating scale', 'changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation', 'mean pelvic pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.107811,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","[{'ForeName': 'Ane Sigrid', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona Birgitte', 'Initials': 'MB', 'LastName': 'Rydningen', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Wojniusz', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Marthe', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Clinical Research Department, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Rolv-Ole', 'Initials': 'RO', 'LastName': 'Lindsetmo', 'Affiliation': 'Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro Killi', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13896']
42,32383347,"Effect of personalised, mobile-accessible discharge instructions for patients leaving the emergency department: A randomised controlled trial.","OBJECTIVE


This pilot study assessed the efficacy of personalised, printed and mobile-accessible discharge instructions for pain relief for patients discharged from the ED.
METHODS


Patients presenting with pain caused by acute musculoskeletal or visceral complaints not requiring admission were eligible. Both groups received usual pain relief discharge advice, the intervention group received additional personalised printed and mobile-accessible discharge instructions. Numerical Rating Scale pain scores were measured at ED visit. Pain scores, Patient Global Impression of Change scale improvement scores, satisfaction with instructions, recall of pain relief advice, receipt of side effects advice and unscheduled visits were measured at 5 days.
RESULTS


A total of 80 patients, recruited over 14 days, were randomly allocated to the intervention or control group. Two patients were excluded and 81% (n = 65) were followed up at 5 days. There was no significant difference in change of pain scores or improvement scores between groups from visit to 5 day follow up. The intervention group showed significantly higher odds of being 'very satisfied' compared to the control group (odds ratio [OR] 7.14, 95% confidence interval [CI] 1.18-50.00), significantly higher odds of full recall of pain relief medication advice (OR 20.00, 95% CI 1.56-100.00) and significantly higher odds of receiving information on medication side effects (OR 6.25, 95% CI 1.67-20.00).
CONCLUSIONS


Patients who received personalised printed and mobile-accessible ED discharge instructions for pain relief reported higher levels of satisfaction with their instructions, had better recall of their pain relief medications advice and received more information on medication side-effects.",2020,"The intervention group showed significantly higher odds of being 'very satisfied' compared to the control group (odds ratio [OR] 7.14, 95% confidence interval [CI] 1.18-50.00), significantly higher odds of full recall of pain relief medication advice (OR 20.00, 95% CI 1.56-100.00) and significantly higher odds of receiving information on medication side effects (OR 6.25, 95% CI 1.67-20.00).
","['80 patients, recruited over 14\u2009days', 'Patients presenting with pain caused by acute musculoskeletal or visceral complaints not requiring admission were eligible', 'patients leaving the emergency department']","['personalised printed and mobile-accessible ED discharge instructions', 'personalised, printed and mobile-accessible discharge instructions', 'personalised, mobile-accessible discharge instructions', 'usual pain relief discharge advice, the intervention group received additional personalised printed and mobile-accessible discharge instructions']","['Pain scores, Patient Global Impression of Change scale improvement scores, satisfaction with instructions, recall of pain relief advice, receipt of side effects advice and unscheduled visits', 'pain relief', 'medication side effects', ""higher odds of being 'very satisfied"", 'Numerical Rating Scale pain scores', 'full recall of pain relief medication advice', 'change of pain scores or improvement scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",65.0,0.363568,"The intervention group showed significantly higher odds of being 'very satisfied' compared to the control group (odds ratio [OR] 7.14, 95% confidence interval [CI] 1.18-50.00), significantly higher odds of full recall of pain relief medication advice (OR 20.00, 95% CI 1.56-100.00) and significantly higher odds of receiving information on medication side effects (OR 6.25, 95% CI 1.67-20.00).
","[{'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Doyle', 'Affiliation': 'The Myer Foundation, Melbourne, Victoria, Australia.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Rippey', 'Affiliation': 'Emergency Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'Department of Research, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Alethea M', 'Initials': 'AM', 'LastName': 'Rea', 'Affiliation': 'Centre for Applied Statistics, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Bronwyn N', 'Initials': 'BN', 'LastName': 'Kaiser', 'Affiliation': 'Emergency Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Miller', 'Affiliation': 'Emergency Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Matthew Hr', 'Initials': 'MH', 'LastName': 'Anstey', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13516']
43,32385554,Randomized controlled trial of chlorhexidine wash versus benzoyl peroxide soap for home surgical preparation: neither is effective in removing Cutibacterium from the skin of shoulder arthroplasty patients.,"INTRODUCTION


Home chlorhexidine washes prior to shoulder surgery are commonly used in an attempt to reduce the skin bacterial load. However, recent studies have suggested that this agent is relatively ineffective against Cutibacterium acne. Benzoyl peroxide soap is a treatment for acne, but evidence regarding its effectiveness as prophylaxis in shoulder surgery is lacking. Therefore, the objective of this study was to compare the effectiveness of home chlorhexidine washes with benzoyl peroxide soap (BPO) in patients undergoing shoulder arthroplasty surgery in reducing Cutibacterium levels on the skin surface and in the dermis.
METHODS


Fifty male patients planning to undergo shoulder arthroplasty were consented to be randomized into treatment with 4% chlorhexidine solution (CHG) and 10% benzoyl peroxide soap (BPO) used to wash the operative shoulder the night prior and morning of surgery. Skin swabs prior to incision and dermal wound swabs after incision were obtained, and the bacterial load was reported in a semiquantitative manner as the Specimen Cutibacterium Value (SpCuV). The two groups were compared with regards to the percent positivity of the skin surface and incised dermal edge as well as the bacterial load at each site.
RESULTS


Skin surface swabs were positive in 100% of patients using CHG and 100% of patients using BPO soap. The Cutibacterium load (SpCuV) on the skin surface was similar between the two groups (CHG 1.6 ± 1.1 vs. BPO 1.5 ± 1.4, p = 0.681). The percentages of dermal cultures that were positive were not significantly different between the two groups (CHG 61% vs BPO 46%, p = 0.369). The Cutibacterium load (SpCuV) on the incised dermal edge was similar between the two groups (CHG 0.8 ± 1.0 vs. BPO 0.8 ± 1.4, p = 0.991).
DISCUSSION


Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge. Further study of means of reducing the Cutibacterium load of the skin at the time of shoulder arthroplasty is warranted.",2020,Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge.,"['Fifty male patients planning to undergo shoulder arthroplasty', 'patients undergoing shoulder arthroplasty surgery in reducing Cutibacterium levels on the skin surface and in the dermis', 'shoulder arthroplasty patients']","['benzoyl peroxide soap', 'chlorhexidine washes with benzoyl peroxide soap (BPO', 'chlorhexidine', 'Benzoyl peroxide soap', 'chlorhexidine solution (CHG) and 10% benzoyl peroxide soap (BPO) used to wash the operative shoulder the night prior and morning of surgery']","['Cutibacterium load (SpCuV) on the incised dermal edge', 'Cutibacterium load (SpCuV) on the skin surface', 'percentages of dermal cultures']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4433919', 'cui_str': 'Cutibacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}]","[{'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C4433919', 'cui_str': 'Cutibacterium'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",50.0,0.0230374,Neither BPO soap nor chlorhexidine washes prior to shoulder surgery were effective in eliminating Cutibacterium from the skin surface or the incised dermal edge.,"[{'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Anastasia J', 'Initials': 'AJ', 'LastName': 'Whitson', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Woodhead', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Napierala', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Davin', 'Initials': 'D', 'LastName': 'Gong', 'Affiliation': 'University of Washington School of Medicine, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA.'}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Matsen', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, University of Washington, 1959 NE Pacific St., Box 356500, Seattle, WA, 98195, USA. matsen@uw.edu.'}]",International orthopaedics,['10.1007/s00264-020-04594-x']
44,32385678,"Adherence to Pre-exposure Prophylaxis in Black Men Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY.","While oral pre-exposure prophylaxis (PrEP) has proven efficacious for HIV prevention, consistent use is necessary to achieve its intended impact. We compared effectiveness of enhanced PrEP (enPrEP) adherence support to standard of care (sPrEP) among Black MSM and TGW attending a community clinic in Harlem, NY. EnPrEP included peer navigation, in-person/online support groups, and SMS messages. Self-reported adherence over previous 30 days, collected in quarterly interviews, was defined as ≥ 57%. Crude and adjusted analyses examined factors associated with adherence. A total of 204 participants were enrolled and randomized; 35% were lost to follow-up. PrEP adherence was 30% at 12-months; no intervention effect was observed (p = 0.69). Multivariable regression analysis found that lower adherence was associated with low education and depressive symptoms. We found that an enhanced adherence intervention did not improve PrEP adherence. Findings point to the need for innovative methods to improve PrEP adherence among Black MSM and TGW.Clinical Trial Registration NCT02167386, June 19, 2014.",2020,PrEP adherence was 30% at 12-months; no intervention effect was observed (p = 0.69).,"['Black MSM and TGW attending a community clinic in Harlem, NY', 'Black Men', '204 participants were enrolled and randomized; 35% were lost to follow-up', 'Who Have Sex with Men and Transgender Women in a Community Setting in Harlem, NY']","['Pre-exposure Prophylaxis', 'oral pre-exposure prophylaxis (PrEP', 'enhanced PrEP (enPrEP) adherence support to standard of care (sPrEP']",['PrEP adherence'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",204.0,0.0710274,PrEP adherence was 30% at 12-months; no intervention effect was observed (p = 0.69).,"[{'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Colson', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA. Pwc2@columbia.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Franks', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Winterhalter', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ortega', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'El-Sadr', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hirsch-Moverman', 'Affiliation': 'Harlem Prevention Center, ICAP at Columbia University, New York, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02901-6']
45,32390729,The Achilles Tendon Response to a Bout of Running is not affected by Triceps Surae Stretch Training in Runners.,"An acute bout of distance running decreases Achilles tendon CSA. The purpose of this study was to examine if three-week stretch training of the Achilles tendon alters the Achilles tendon thinning response to running. Thirty-three recreational runners were divided into a control group (n = 17) and an intervention group (n = 16). The intervention included a three-week soleus stretch (knee flexed) and gastrocnemius stretch (knee extended). Three gastrocnemius stretches and three soleus stretches were performed each day, six days per week. Stretches were held for 30 s per repetition for a total duration of 180 s per leg per day. Achilles tendon CSA and range of motion measures were completed pre and post-run before and after the three-week stretching intervention. The runs prior to and following the three-week stretch training intervention both resulted in a 6% decrease in Achilles tendon CSA (p < 0.0001). There was no interaction across time between control and intervention groups in CSA (p = 0.446). Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009). We therefore conclude that even when an increased dorsiflexion range of motion occurs, three weeks of triceps surae stretching does not alter the response of the Achilles tendon CSA.",2020,Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009).,"['Thirty-three recreational runners', 'Runners']",['distance running'],"['dorsiflexion range of motion', 'Achilles tendon CSA', 'Achilles tendon CSA and range of motion measures']","[{'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0210059,Only the intervention group experienced a significant increase in dorsiflexion range of motion following the stretch training (p = 0.009).,"[{'ForeName': 'Coulter D', 'Initials': 'CD', 'LastName': 'Neves', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Sponbeck', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Katy Andrews', 'Initials': 'KA', 'LastName': 'Neves', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Ulrike H', 'Initials': 'UH', 'LastName': 'Mitchell', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Hunter', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Aaron Wayne', 'Initials': 'AW', 'LastName': 'Johnson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}]",Journal of sports science & medicine,[]
46,32390731,Occlusion Training During Specific Futsal Training Improves Aspects of Physiological and Physical Performance.,"This study aimed to examine the effects of lower limb blood flow restriction (BFR) performed during 3-a-side futsal game training on aerobic and anaerobic performance of futsal players. Twelve male futsal players were randomized into two groups (n = 6); both groups performed ten sessions of the 3-a-side game every other day in half of a futsal court; but one group trained under BFR conditions. Pneumatic cuffs used for the BFR group were inflated to 110% leg systolic blood pressure and increased by 10% after each two completed sessions. Before and after the training sessions subjects completed a series of tests to assess aerobic and anaerobic performances along with changes in blood lactate and anabolic and catabolic hormones. All aerobic and anaerobic performance variables improved in both group after training, however improvements in mean power (12.2%, p = 0.03), run time to fatigue (TTF), (7.1%, p = 0.02) and running economy (RE), (-22.7%, p = 0.01) were significantly greater in the BFR group. There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group. Small-sided game (SSG) training with the addition of BFR because of accumulated metabolites and hormonal changed leads to substantially greater increases in performance than SSGs training alone.",2020,"There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group.","['futsal players', 'Twelve male futsal players']","['Occlusion Training During Specific Futsal Training', 'lower limb blood flow restriction (BFR) performed during 3-a-side futsal game training', 'Small-sided game']","['mean power', 'All aerobic and anaerobic performance variables', 'growth hormone', 'blood lactate and anabolic and catabolic hormones', 'Physiological and Physical Performance', 'run time to fatigue (TTF', 'rate of lactate removal', 'running economy (RE', 'leg systolic blood pressure', 'testosterone to cortisol ratio']","[{'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",12.0,0.0159885,"There were also significant increases in growth hormone (p = 0.01), testosterone to cortisol ratio at first session (p = 0.01) and rate of lactate removal (p = 0.01) at last session in the BFR group compared to the non-BFR group.","[{'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sarikhani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Paton', 'Affiliation': 'Faculty of Health and Sport Science, the Eastern Institute of Technology, Napier, New Zealand.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Bayati', 'Affiliation': 'Department of Exercise Physiology, Sports Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, Nikaia, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Medbase St. Gallen Am Vadianplatz, St. Gallen, Switzerland.'}]",Journal of sports science & medicine,[]
47,32390736,Acute Effects of Dynamic Stretching Followed by Vibration Foam Rolling on Sports Performance of Badminton Athletes.,"Dynamic stretching (DS) is performed to increase sports performance and is also used primarily for transiently increasing range of motion (ROM). Recently, vibration foam rolling (VFR) has emerged. Its underlying concept is that it combines foam rolling techniques with local vibration to improve ROM and muscular activation concurrently. This crossover study investigated the effects of DS or DS followed by VFR (DS + VFR) during warm-ups on flexibility, muscle stiffness, power, and agility of the lower limbs in badminton athletes. Forty badminton players performed DS or DS + VFR as warm-up exercises on two occasions in a randomized order. The target muscle groups were the bilateral shoulder, anterior and posterior thigh, posterior calf, and lower back. Main outcome measures: The primary outcome was knee range of motion (ROM), and the secondary outcomes were muscle stiffness, lower limb power (countermovement jump [CMJ]), and agility. Results indicated that the protocols improved performance. DS increased knee flexion ROM (% change = 1.92, ES = 0.3, p = 0.033), CMJ height (% change = 5.04, ES = 0.2, p = 0.004), and agility (% change = -4.97, ES = 0.4, p < 0.001) but increased quadriceps muscle stiffness (% change = 3.74, ES = 0.3, p = 0.001) and increased gastrocnemius muscle stiffness (% change = 10.39, ES = 0.5, p = 0.001). DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001). DS + VFR was not significantly superior to DS, except for muscle stiffness reduction. Taken together, we suggest that practitioners consider DS as a first line of warm-up exercise to increase ROM, CMJ height, and agility in athletes. Moreover, the addition of VFR to DS results in a large reduction of muscle stiffness, potentially reducing the risk of sports injury. Athletes, coaches and athletic professionals may consider them when selecting effective warm-up practices to augment athletic performance.",2020,"DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001).","['badminton athletes', 'Sports Performance of Badminton Athletes']","['Dynamic Stretching Followed by Vibration Foam Rolling', 'DS or DS followed by VFR (DS + VFR', 'DS + VFR', 'Dynamic stretching (DS']","['reduced quadriceps muscle stiffness', 'quadriceps muscle stiffness', 'performance', 'flexibility, muscle stiffness, power, and agility of the lower limbs', 'CMJ height', 'gastrocnemius muscle stiffness', 'DS or DS + VFR', 'knee extension ROM', 'DS increased knee flexion ROM', 'DS + VFR', 'knee range of motion (ROM), and the secondary outcomes were muscle stiffness, lower limb power (countermovement jump [CMJ]), and agility', 'ROM, CMJ height, and agility in athletes']","[{'cui': 'C0004678', 'cui_str': 'Badminton'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.0380452,"DS + VFR increased knee extension ROM (% change =2.87, ES = 0.4, p = 0.003), reduced quadriceps muscle stiffness (% change = -2.79, ES = 0.3, p = 0.017), CMJ height (% change = 2.41, ES = 0.1, p = 0.037), and agility (% change = -4.74, ES = 0.2, p < 0.001).","[{'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-sen University, Kaohsiung 804, Taiwan.'}, {'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",Journal of sports science & medicine,[]
48,32387055,Timing of Peak Vision Gains in Patients with Neovascular Age-Related Macular Degeneration Treated with Ranibizumab.,"PURPOSE


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


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


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


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


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


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


In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab. These findings suggest that continued treatment may result in greater vision improvements when consistent anti-vascular endothelial growth factor therapy is maintained over a longer period.",2020,"In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab.","['Patients with Neovascular Age-Related Macular Degeneration Treated with', 'patients with neovascular age-related macular degeneration (nAMD) who received', 'Treatment-naïve patients 50 years of age or older with subfoveal nAMD']","['Ranibizumab', 'ranibizumab']","['baseline demographic and clinical characteristics, presence of persistent subretinal fluid (SRF) or intraretinal fluid (IRF), and on-study events (atrophy status, fibrosis, retinal pigment epithelium\xa0tears', 'time to peak best-corrected visual acuity (BCVA', 'peak BCVA', 'Time to peak BCVA and its predictive value for magnitude of BCVA changes and BCVA', 'average lost vision', 'vision outcomes', 'vision gains', 'patient characteristics, persistent SRF or IRF', 'vision improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.134321,"In most treatment-naïve patients with nAMD, vision gains were achieved at a slower rate (>6 months), and a slower response was associated with better vision outcomes after 24 months of ranibizumab.","[{'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California. Electronic address: rnkhurana@gmail.com.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Bann-Mo', 'Initials': 'BM', 'LastName': 'Day', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Avanti', 'Initials': 'A', 'LastName': 'Ghanekar', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoilov', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.02.011']
49,32388538,Serotonin differentially modulates the temporal dynamics of the limbic response to facial emotions in male adults with and without autism spectrum disorder (ASD): a randomised placebo-controlled single-dose crossover trial.,"Emotion processing-including signals from facial expressions-is often altered in individuals with autism spectrum disorder (ASD). The biological basis of this is poorly understood but may include neurochemically mediated differences in the responsivity of key 'limbic' regions (including amygdala, ventromedial prefrontal cortex (vmPFC) and nucleus accumbens (NAc)). Emerging evidence also suggests that ASD may be a disorder of brain temporal dynamics. Moreover, serotonin (5-HT) has been shown to be a key regulator of both facial-emotion processing and brain dynamics, and 5-HT abnormalities have been consistently implicated in ASD. To date, however, no one has examined how 5-HT influences the dynamics of facial-emotion processing in ASD. Therefore, we compared the influence of 5-HT on the responsivity of brain dynamics during facial-emotion processing in individuals with and without ASD. Participants completed a facial-emotion processing fMRI task at least 8 days apart using a randomised double-blind crossover design. At each visit they received either a single 20-mg oral dose of the selective serotonin reuptake inhibitor (SSRI) citalopram or placebo. We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults. The neurotypical adults' limbic response reverted more rapidly to baseline following a 5-HT-challenge. Our results suggest that serotonergic homoeostatic control of the temporal dynamics in limbic regions is altered in adults with ASD, and provide a fresh perspective on the biology of ASD.",2020,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"['individuals with autism spectrum disorder (ASD', 'individuals with and without ASD', 'male adults with and without autism spectrum disorder (ASD', 'adults with ASD']","['serotonin (5-HT', 'citalopram', 'Serotonin', 'selective serotonin reuptake inhibitor (SSRI) citalopram or placebo', 'Emotion processing-including signals from facial expressions', '5-HT', 'placebo']",['facial-emotion processing fMRI task'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.311869,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"[{'ForeName': 'Nichol M L', 'Initials': 'NML', 'LastName': 'Wong', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. nichol.wong@kcl.ac.uk.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Findon', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vladimira', 'Initials': 'V', 'LastName': 'Stoencheva', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blainey', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Grainne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0693-0']
50,32327729,Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma.,"In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.",2020,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).",[],"['placebo', 'ixazomib versus placebo', 'ixazomib']","['partial response or partial response (VGPR/PR', 'progression-free survival (PFS', '24-month PFS rate', 'median PFS', 'Median PFS', 'progression-free survival']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273711', 'cui_str': 'ixazomib'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0931225,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Internal Medicine V and National Center for Tumor Diseases (NCT), University Clinic Heidelberg, Heidelberg, Germany. Hartmut.Goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology & Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Mikala', 'Affiliation': 'South Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford University Hospitals, NHS Foundation Trust, Oxford Myeloma Centre for Translational Research, Oxford, UK.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, IBSAL, CIC, IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Leukemia,['10.1038/s41375-020-0819-8']
51,32394777,"Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety.","Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI. Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre- and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET+CTI and 20 (44%) in the control group. The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38;  P =0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET+CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET+CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02272426.",2020,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"['Stroke', 'We enrolled 131 participants, of whom 37 withdrew from the study', 'patients presenting with recent stroke to a comparison of a']","['Combined Aerobic, Resistance, and Cognitive Training', 'combined aerobic, resistance, and cognitive training intervention (CARET+CTI', 'supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI', ' Physical exercise and cognitive training']","['Greater gains in physical, cognitive, and mood outcomes', 'feasibility, adherence, and safety', 'feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety', 'strength, endurance, and cognition', 'Feasibility and Safety', 'observed-over-expected visit ratio']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",131.0,0.0361699,The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marialaura', 'Initials': 'M', 'LastName': 'Simonetto', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Clinton B', 'Initials': 'CB', 'LastName': 'Wright', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Chuanhui', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bustillo', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Perez-Pinzon', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Kunjan R', 'Initials': 'KR', 'LastName': 'Dave', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Carolina M', 'Initials': 'CM', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Marti', 'Initials': 'M', 'LastName': 'Flothmann', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'M Carolina', 'Initials': 'MC', 'LastName': 'Mendoza-Puccini', 'Affiliation': 'National Institute of Neurological Disorders and Stroke (NINDS) Bethesda MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Junco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Zuzel', 'Initials': 'Z', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Gomes-Osman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Rundek', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Department of Neurology Miller School of Medicine University of Miami FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015377']
52,32375553,Prediction of Residual Risk by Ceramide-Phospholipid Score in Patients With Stable Coronary Heart Disease on Optimal Medical Therapy.,"Background Identification of patients with stable coronary heart disease who are at significant residual risk could be helpful for targeted prevention. Our aim was to determine the prognostic value of the recently introduced ceramide- and phospholipid-based risk score, the Cardiovascular Event Risk Test (CERT2), in patients with stable coronary heart disease on optimal medical therapy and to identify biological processes that contribute to the CERT2 score. Methods and Results Plasma samples (n=11 222) obtained from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) trial were analyzed using a tandem liquid chromatography-mass spectrometry method. STABILITY was a trial in patients with stable coronary heart disease randomized to the lipoprotein-associated phospholipase A2 inhibitor darapladib or placebo on optimized medical therapy at baseline, with a median follow-up of 3.7 years. Hazard ratios per SD for the CERT2 risk score were 1.32 (95% CI, 1.25-1.39) for major adverse cardiovascular event, 1.47 (95% CI, 1.35-1.59) for cardiovascular death, 1.32 (95% CI, 1.16-1.49) for stroke, 1.23 (95% CI, 1.14-1.33) for myocardial infarction, and 1.56 (95% CI, 1.39-1.76) for hospitalization due to heart failure, when adjusted for traditional cardiovascular risk factors. CERT2 showed correlation ( P <0.001,  r >0.2) with inflammatory markers high-sensitivity C-reactive protein, interleukin 6, the heart failure marker N-terminal pro-B-type natriuretic peptide, and low-density lipoprotein cholesterol. After also adjusting for levels of other prognostic biomarkers, the CERT2 score was still independently related to the risk of cardiovascular death but not to nonfatal events. Conclusions The CERT2 risk score can detect residual risk in patients with stable coronary heart disease and is associated with biomarkers indicating inflammation, myocardial necrosis, myocardial dysfunction, renal dysfunction, and dyslipidemia. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT00799903.",2020,"Hazard ratios per SD for the CERT2 risk score were 1.32 (95% CI, 1.25-1.39) for major adverse cardiovascular event, 1.47 (95% CI, 1.35-1.59) for cardiovascular death, 1.32 (95% CI, 1.16-1.49) for stroke, 1.23 (95% CI, 1.14-1.33) for myocardial infarction, and 1.56 (95% CI, 1.39-1.76) for hospitalization due to heart failure, when adjusted for traditional cardiovascular risk factors.","['patients with stable coronary heart disease on optimal medical therapy', 'on optimized medical therapy at baseline, with a median follow-up of 3.7\xa0years', 'patients with stable coronary heart disease randomized to the', 'patients with stable coronary heart disease', 'Patients With Stable Coronary Heart Disease on Optimal Medical Therapy']",['lipoprotein-associated phospholipase A2 inhibitor darapladib or placebo'],"['myocardial infarction', 'Hazard ratios per SD for the CERT2 risk score', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0893636', 'cui_str': 'phospholipase A2 inhibitor'}, {'cui': 'C2348075', 'cui_str': 'darapladib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0533902,"Hazard ratios per SD for the CERT2 risk score were 1.32 (95% CI, 1.25-1.39) for major adverse cardiovascular event, 1.47 (95% CI, 1.35-1.59) for cardiovascular death, 1.32 (95% CI, 1.16-1.49) for stroke, 1.23 (95% CI, 1.14-1.33) for myocardial infarction, and 1.56 (95% CI, 1.39-1.76) for hospitalization due to heart failure, when adjusted for traditional cardiovascular risk factors.","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Hilvo', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Tatevik', 'Initials': 'T', 'LastName': 'Ghukasyan Lakic', 'Affiliation': 'Uppsala Clinical Research Center Uppsala Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kauhanen', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Jylhä', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindbäck', 'Affiliation': 'Uppsala Clinical Research Center Uppsala Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Department of Medical Sciences Uppsala University Uppsala Sweden.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Medical Center Duke University Durham NC.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München Technische Universität München München Germany and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance Munich Germany.'}, {'ForeName': 'Ralph A H', 'Initials': 'RAH', 'LastName': 'Stewart', 'Affiliation': 'N Green Lane Cardiovascular Service Auckland City Hospital and University of Auckland New Zealand.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'White', 'Affiliation': 'N Green Lane Cardiovascular Service Auckland City Hospital and University of Auckland New Zealand.'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Laaksonen', 'Affiliation': 'Zora Biosciences Oy Espoo Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.015258']
53,32382078,Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL.,"BACKGROUND


The ExoDx Prostate(IntelliScore) (EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy. We sought to assess the impact of EPI on the decision to biopsy in a real-world clinical setting.
METHODS


We conducted a prospective, randomized, blinded, two-armed clinical utility study that enrolled 1094 patients with 72 urologists from 24 urology practices. Patients were considered for prostate biopsy at enrollment based on standard clinical criteria. All patients had an EPI test; however, patients were randomized into EPI vs. control arms where only the EPI arm received results for their biopsy decision.
RESULTS


In the EPI arm (N = 458), 93 patients received negative EPI scores of which 63% were recommended to defer biopsy by the urologist and 74% ultimately deferred. In contrast, 87% of patients with positive EPI scores were recommended to undergo biopsy with a 72% compliance rate to the urologist's recommendation. This led to detection of 30% more HGPC compared to the control arm, and we estimate that 49% fewer HGPC were missed due to deferrals compared to standard of care (SOC). Overall, 68% of urologists reported that the EPI test influenced their biopsy decision. The primary reason not to comply with EPI results was rising PSA.
CONCLUSION


To our knowledge this is the first report on a PC biomarker utility study with a blinded control arm. The study demonstrates that the EPI test influences the overall decision to defer or proceed with a biopsy and improves patient stratification.",2020,(EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy.,"['men presenting for initial Biopsy with a PSA 2-10\u2009ng/mL', 'enrolled 1094 patients with 72 urologists from 24 urology practices']","['exosome based ExoDx Prostate(IntelliScore', 'EPI']",['negative EPI scores'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0260314', 'cui_str': 'Urologist'}, {'cui': 'C0042077', 'cui_str': 'Urology'}]","[{'cui': 'C2350332', 'cui_str': 'Exosomes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1094.0,0.103729,(EPI) test is a non-invasive risk assessment tool for detection of high-grade prostate cancer (HGPC) that informs whether to proceed with prostate biopsy.,"[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': 'Chesapeake Urology Associates, Baltimore, MD, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Donovan', 'Affiliation': 'Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Phillipp', 'Initials': 'P', 'LastName': 'Torkler', 'Affiliation': 'Exosome Diagnostics GmbH, a Bio-Techne brand, Martinsried, Germany.'}, {'ForeName': 'Vasisht', 'Initials': 'V', 'LastName': 'Tadigotla', 'Affiliation': 'Exosome Diagnostics Inc, a Bio-Techne brand, Waltham, MA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McLain', 'Affiliation': 'Exosome Diagnostics Inc, a Bio-Techne brand, Waltham, MA, USA.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Noerholm', 'Affiliation': 'Exosome Diagnostics GmbH, a Bio-Techne brand, Martinsried, Germany.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Skog', 'Affiliation': 'Exosome Diagnostics Inc, a Bio-Techne brand, Waltham, MA, USA. Johan.skog@bio-techne.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKiernan', 'Affiliation': 'Department of Urology, Columbia University Medical Center, New York, NY, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0237-z']
54,32382922,Tunnel technique with enamel matrix derivative in addition to subepithelial connective tissue graft compared with connective tissue graft alone for the treatment of multiple gingival recessions: a randomized clinical trial.,"OBJECTIVES


The aim of this study was to compare outcomes of the modified coronally advanced tunnel technique (MCAT) combined with subepithelial connective tissue graft (SCTG) with or without enamel matrix derivative (EMD), in the treatment of gingival recession types 1 and 2.
MATERIALS AND METHODS


A total of 20 patients with 150 multiple gingival recessions (GR) were included in the study. On one side, MCAT was combined with SCTG and EMD (tests), whereas MCAT with SCTG was applied on the contralateral side (controls). Clinical parameters were measured at baseline and 6 months after surgery. Visual analog scales (VAS) and questionnaires were used to assess patient-reported outcomes and the root coverage esthetic score (RES) for professional esthetic evaluation.
RESULTS


MCAT+SCTG+EMD was not superior with regard to root coverage. At 6 months, average root coverage (ARC) was 87.4% for SCTG+EMD-treated and 90.9% for SCTG-treated defects (p = 0.4170). Complete root coverage (CRC) was observed in 86.7% (tests) and 85.3% (controls) of the cases (p = 0.9872). Significantly less pain was reported using VAS (p = 0.0342) post-operatively in the SCTG+EMD group. Professional assessment of esthetic outcomes using RES showed a significant difference (9.25 versus 8.71, p = 0.0103) in favor of the test group.
CONCLUSIONS


Both treatment modalities were equally effective in treatment of multiple GR and led to similar improvements in clinical parameters. However, the application of EMD as an adjunct resulted in less post-operative pain and better professionally assessed esthetic outcomes.
CLINICAL RELEVANCE


Patients' early morbidity and 6-month esthetic outcomes following GR coverage with MCAT might be influenced by means of EMD utilization.",2020,Significantly less pain was reported using VAS (p = 0.0342,"['gingival recession types 1 and 2', 'multiple gingival recessions', '20 patients with 150 multiple gingival recessions (GR']","['Tunnel technique with enamel matrix derivative', 'MCAT with SCTG', 'modified coronally advanced tunnel technique (MCAT) combined with subepithelial connective tissue graft (SCTG) with or without enamel matrix derivative (EMD', 'MCAT', 'connective tissue graft alone']","['root coverage esthetic score (RES', 'average root coverage (ARC', 'Complete root coverage (CRC', 'pain', 'Visual analog scales (VAS) and questionnaires']","[{'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",20.0,0.0444585,Significantly less pain was reported using VAS (p = 0.0342,"[{'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Górski', 'Affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, S. Binieckiego 6 St, 02-097, Warsaw, Poland. bartek_g3@tlen.pl.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Górska', 'Affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, S. Binieckiego 6 St, 02-097, Warsaw, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wysokińska-Miszczuk', 'Affiliation': 'The Chair and Department of Periodontology, Medical University of Lublin, Karmelicka 7 St, 20-081, Lublin, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kaczyński', 'Affiliation': 'Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, S. Binieckiego 6 St, 02-097, Warsaw, Poland.'}]",Clinical oral investigations,['10.1007/s00784-020-03312-6']
55,32385765,"In shoulder adhesive capsulitis, ultrasound-guided anterior hydrodilatation in rotator interval is more effective than posterior approach: a randomized controlled study.","Shoulder adhesive capsulitis, also called frozen shoulder, is a musculoskeletal disorder associated with pain and functional disability. This study aimed to compare the effectiveness of shoulder ultrasound-guided hydrodilatation with corticosteroid, via rotator interval (RI) anteriorly, versus posterior approach, in adhesive capsulitis patients. All patients received exercise program following injection.
PATIENTS AND METHODS


A prospective randomized controlled study among 60 consecutive adhesive capsulitis patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach. Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
RESULTS


Both groups showed significant improvement 3 months after hydrodilatation regarding VAS pain, external rotation, and SPADI. Only in group II (RI anterior approach) improvement was observed regarding flexion and abduction. There was no improvement regarding extension or internal rotation in either group. When comparing the improvement in both groups after hydrodilatation, group II (anterior approach) showed a statistically significant higher level of improvement regarding VAS pain (p = 0.003), SPADI, flexion, abduction, and external rotation, compared to group I (p < 0.001). Extension, internal rotation, and adduction were not different.
CONCLUSIONS


Ultrasound-guided anterior rotator interval hydrodilatation for adhesive capsulitis, followed by guided exercise, is clinically and functionally more effective than the conventional posterior approach.",2020,There was no improvement regarding extension or internal rotation in either group.,"['60 consecutive adhesive capsulitis patients', 'adhesive capsulitis patients']","['guided stretching exercises', 'exercise program following injection', 'ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach', 'shoulder ultrasound-guided hydrodilatation with corticosteroid, via rotator interval (RI) anteriorly, versus posterior approach']","['SPADI, flexion, abduction, and external rotation', 'flexion and abduction', 'VAS pain, external rotation, and SPADI', 'pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM', 'Extension, internal rotation, and adduction', 'extension or internal rotation', 'VAS pain']","[{'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",60.0,0.0893016,There was no improvement regarding extension or internal rotation in either group.,"[{'ForeName': 'Basant', 'Initials': 'B', 'LastName': 'Elnady', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Rageh', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Manal Shawky', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammed Hassan', 'Initials': 'MH', 'LastName': 'Abu-Zaid', 'Affiliation': 'Department of Rheumatology, Rehabilitation and Physical Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Dalia El-Sayed', 'Initials': 'DE', 'LastName': 'Desouky', 'Affiliation': 'Department of public health and community medicine, Menoufia University, Shibin Al Kawm, Egypt.'}, {'ForeName': 'Tohamy', 'Initials': 'T', 'LastName': 'Ekhouly', 'Affiliation': 'Department of Radiology, Benha University, Benha, Egypt.'}, {'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Rasker', 'Affiliation': 'Faculty of Behavioral, Management and Social sciences, Department Psychology, Health and Technology, University of Twente, PO box 217, 7500 AE, Enschede, Netherlands. j.j.rasker@utwente.nl.'}]",Clinical rheumatology,['10.1007/s10067-020-05131-2']
56,32390503,Handling missing data in modelling quality of clinician-prescribed routine care: Sensitivity analysis of departure from missing at random assumption.,"Missing information is a major drawback in analyzing data collected in many routine health care settings. Multiple imputation assuming a missing at random mechanism is a popular method to handle missing data. The missing at random assumption cannot be confirmed from the observed data alone, hence the need for sensitivity analysis to assess robustness of inference. However, sensitivity analysis is rarely conducted and reported in practice. We analyzed routine paediatric data collected during a cluster randomized trial conducted in Kenyan hospitals. We imputed missing patient and clinician-level variables assuming the missing at random mechanism. We also imputed missing clinician-level variables assuming a missing not at random mechanism. We incorporated opinions from 15 clinical experts in the form of prior distributions and shift parameters in the delta adjustment method. An interaction between trial intervention arm and follow-up time, hospital, clinician and patient-level factors were included in a proportional odds random-effects analysis model. We performed these analyses using R functions derived from the  jomo  package. Parameter estimates from multiple imputation under the missing at random mechanism were similar to multiple imputation estimates assuming the missing not at random mechanism. Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.",2020,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,['Kenyan hospitals'],[],[],"[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.0221474,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gachau', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Quartagno', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Edmund Njeru', 'Initials': 'EN', 'LastName': 'Njagi', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Owuor', 'Affiliation': 'School of Mathematics, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'English', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ayieko', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}]",Statistical methods in medical research,['10.1177/0962280220918279']
57,32391656,Long-term outcomes after perioperative treatment with omega-3 fatty acid supplements in colorectal cancer.,"BACKGROUND


This study aimed to evaluate the effect of perioperative supplementation with omega-3 fatty acids (n-3 FA) on perioperative outcomes and survival in patients undergoing colorectal cancer surgery.
METHODS


Patients scheduled for elective resection of colorectal cancer between 2007 and 2010 were randomized to either an n-3 FA-enriched oral nutrition supplement (ONS) twice daily or a standard ONS (control) for 7 days before and after surgery. Outcome measures, including postoperative complications, 3-year cumulative incidence of local or metastatic colorectal cancer recurrence and 5-year overall survival, were compared between the groups.
RESULTS


Of 148 patients enrolled in the study, 125 (65 patients receiving n-3 FA-enriched ONS and 60 receiving standard ONS) were analysed. There were no differences in postoperative complications after surgery (P = 0·544). The risk of disease recurrence at 3 years was similar (relative risk 1·66, 95 per cent c.i. 0·65 to 4·26).The 5-year survival rate of patients treated with n-3 FA was 69·2 (95 per cent c.i. 56·5 to 78·9) per cent, compared with 81·7 (69·3 to 89·4) per cent in the control group (P = 0·193). After adjustment for age, stage of disease and adjuvant chemotherapy, n-3 FA was associated with higher mortality compared with controls (hazard ratio 1·73, 95 per cent c.i. 1·06 to 2·83; P = 0·029). The interaction between n-3 FA and adjuvant chemotherapy was not statistically significant.
CONCLUSION


Perioperative supplementation with n-3 FA did not confer a survival benefit in patients undergoing colorectal cancer surgery. n-3 FA did not benefit the subgroup of patients treated with adjuvant chemotherapy or decrease the risk of disease recurrence.",2020,"The risk of disease recurrence at 3 years was similar (relative risk 1·66, 95 per cent c.i.","['Patients scheduled for elective resection of colorectal cancer between 2007 and 2010', '148 patients enrolled in the study, 125 (65 patients receiving', 'colorectal cancer', 'patients undergoing colorectal cancer surgery']","['adjuvant chemotherapy', 'omega-3 fatty acids (n-3 FA', 'n-3 FA', 'n-3 FA-enriched ONS and 60 receiving standard ONS', 'omega-3 fatty acid supplements', 'n-3 FA-enriched oral nutrition supplement (ONS) twice daily or a standard ONS (control', 'n-3 FA and adjuvant chemotherapy']","['5-year survival rate', 'survival benefit', 'postoperative complications, 3-year cumulative incidence of local or metastatic colorectal cancer recurrence and 5-year overall survival', 'postoperative complications', 'risk of disease recurrence', 'perioperative outcomes and survival', 'higher mortality']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",148.0,0.24371,"The risk of disease recurrence at 3 years was similar (relative risk 1·66, 95 per cent c.i.","[{'ForeName': 'L Schmidt', 'Initials': 'LS', 'LastName': 'Sørensen', 'Affiliation': 'Department of Gastrointestinal Surgery, Aalborg, Denmark.'}, {'ForeName': 'S Ladefoged', 'Initials': 'SL', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Gastrointestinal Surgery, Aalborg, Denmark.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'M Nytoft', 'Initials': 'MN', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Oncology, Aalborg, Denmark.'}, {'ForeName': 'E Berg', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg, Denmark.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Thorlacius-Ussing', 'Affiliation': 'Department of Gastrointestinal Surgery, Aalborg, Denmark.'}]",BJS open,['10.1002/bjs5.50295']
58,32388179,Do menopausal status and APOE4 genotype alter the long-term effects of intensive lifestyle intervention on cognitive function in women with type 2 diabetes mellitus?,"In the Look AHEAD trial, randomization to Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE) did not result in differences in cognitive outcomes. However, menopause and APOE genotype are factors that affect the response to this intervention. The effect of this intervention on a single cognitive assessment was examined in 3 groups of women: premenopausal or <5 years postmenopausal (N = 594), within 5-10 years (n = 388), and ≥10 years postmenopausal (n = 963), and as a function of continuous years since menopause. The late postmenopausal group in the ILI had worse composite z-scores compared to those in the DSE, whereas the younger premenopausal or early postmenopausal women in the ILI had better composite z-scores than the DSE. A significant interaction between years since menopause and intervention arm, but not baseline age, was observed on executive function domains. ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause. These findings emphasize the importance of assessing menopause and APOE status to understand how weight loss impacts cognition.",2020,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"['women with type 2 diabetes mellitus', '3 groups of women: premenopausal or <5\xa0years postmenopausal (N\xa0= 594), within 5-10\xa0years (n\xa0= 388), and ≥10\xa0years postmenopausal (n\xa0= 963), and as a function of continuous years since menopause']","['Intensive Lifestyle Intervention (ILI) or Diabetes Support and Education (DSE', 'intensive lifestyle intervention']","['cognitive function', 'composite z-scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.020602,ILI appeared only to benefit cognitive function among non-APOE4 carriers during premenopause or early postmenopause.,"[{'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address: hyassine@usc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Brinton', 'Affiliation': 'Departments of Pharmacology and Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Hugenschmidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Keller', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}]",Neurobiology of aging,['10.1016/j.neurobiolaging.2020.03.020']
59,32393405,Experimental manipulation of beliefs about the importance of thoughts and the effect on an aggressive impulse.,"BACKGROUND


Cognitive models of obsessive-compulsive disorder attribute a causal role to maladaptive beliefs.
AIMS


To test this hypothesis, we manipulated Overimportance of Thoughts (OT) beliefs and experimentally evaluated their effect on the response to an induced aggressive impulse.
METHOD


Eighty-five participants completed a battery of self-report instruments assessing obsession symptoms, thought control, affectivity and obsessive beliefs, and were then randomly assigned to two conditions. In the experimental condition participants read a scientific abstract on the importance of thought control whilst those in the control condition read a neutral abstract. All participants identified a loved person and imagined feeling the impulse to stab this person, then completed again OT beliefs measures (Overimportance of Thought, Moral-Thought Action Fusion and Thought Action Fusion Likelihood).
RESULTS


The Moral component of the Thought Action Fusion was reduced by reading a brief text about the possibility and desirability of thought control. However, experimentally induced changes in beliefs did not yield differences in the intrusiveness of the aggressive impulse.
CONCLUSIONS


Some beliefs can be modified through a single session in which information similar to what could be obtained in quotidian life is provided.",2020,"However, experimentally induced changes in beliefs did not yield differences in the intrusiveness of the aggressive impulse.
","['Eighty-five participants completed a battery of self-report instruments assessing obsession symptoms, thought control, affectivity and obsessive beliefs']",[],[],"[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006122', 'cui_str': 'Brainwashing'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",[],[],85.0,0.0437257,"However, experimentally induced changes in beliefs did not yield differences in the intrusiveness of the aggressive impulse.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jiménez-Ros', 'Affiliation': 'Psychology Research Centre (CIP/UAL) and Universidade do Algarve, Portugal.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Faísca', 'Affiliation': 'Centre for Biomedical Research (CBMR) and Universidade do Algarve, Portugal.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Martins', 'Affiliation': 'Universidade do Algarve.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Janeiro', 'Affiliation': 'Psychology Research Centre (CIP/UAL) and Universidade do Algarve, Portugal.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Martins', 'Affiliation': 'Centre for Biomedical Research (CBMR) and Universidade do Algarve, Portugal.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000120']
60,32396205,Effect of Psychoeducation on Stress in Parents of Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Study.,"The current experimental pre-/posttest study sought to determine the effect of psychoeducation on the stress levels of parents of children with attention-deficit/hyperactivity disorder (ADHD). A total of 172 parents participated and were randomly assigned to experimental (n = 86) and control (n = 86) groups. There was no significant difference between mean pretest scores of parents in the experimental and control groups on the Caregiver Stress Scale (p > 0.005); however, significant differences were found between pre- and posttest scores in the experimental group after psychoeducation and at 6-month follow up (p < 0.001). There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05). In the light of the findings, psychiatric nurses can use psychoeducation programs to support families of children with ADHD to reduce their stress levels. [Journal of Psychosocial Nursing and Mental Health Services, 58(7), 34-41.].",2020,There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05).,"['parents of children with attention-deficit/hyperactivity disorder (ADHD', '172 parents participated and were randomly assigned to experimental (n = 86) and control (n = 86) groups', 'With Attention-Deficit/Hyperactivity Disorder', 'Parents of Children']","['Psychoeducation', 'psychoeducation']","['Caregiver Stress Scale', 'pre- and posttest scores and pretest scores and 6-month follow-up scores']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",172.0,0.0289188,There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05).,"[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Gümüs', 'Affiliation': ''}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Ergün', 'Affiliation': ''}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Dikeç', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200506-01']
61,32396206,Effectiveness of a Nurse-Led Intervention for Adolescents With Problematic Internet Use.,"The current study assessed the effect of an intervention on problematic internet use (PIU), biopsychosocial functioning, and academic performance in 100 adolescents with PIU in grades 9 and 11 in Ernakulam District, Kerala, India. Students from four comparable schools were randomly assigned to experimental and wait-list control groups after being screened for PIU. The experimental group participated in a 10-week intervention and parents of these adolescents were provided with two sessions. The wait-list control group received the intervention after the posttest. A PIU questionnaire, sociodemographic data, internet usage pattern, a biopsychosocial functioning tool, and academic performance were used to assess participants at baseline and immediately after and 3 months postintervention. Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05). Thus, the intervention was effective in reducing PIU among adolescents and improved their physical, psychological, and social functioning and academic performance. [Journal of Psychosocial Nursing and Mental Health Services, 58(7), 16-26.].",2020,"Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05).","['Students from four comparable schools', '100 adolescents with PIU in grades 9 and 11 in Ernakulam District, Kerala, India', 'Adolescents With Problematic Internet Use']",['Nurse-Led Intervention'],"['PIU; physical, psychological, and social functioning; and academic performance', 'physical, psychological, and social functioning and academic performance', 'problematic internet use (PIU), biopsychosocial functioning, and academic performance']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",100.0,0.0373189,"Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05).","[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Krishnan', 'Affiliation': ''}, {'ForeName': 'Adhin', 'Initials': 'A', 'LastName': 'Bhaskar', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200506-03']
62,32406265,Peer Relations and Delinquency Among Girls in Foster Care Following a Skill-Building Preventive Intervention.,"There is evidence that risk for delinquency is elevated among girls with foster care histories, and one correlate of delinquency is affiliating with peers who engage in delinquent behavior. Although intervention studies have shown positive effects of interventions that target delinquent peer affiliation on reductions in delinquency among adolescents with juvenile justice histories, the success of such interventions for younger girls in foster care, without prior involvement with juvenile justice, is unknown. We analyzed data from a randomized clinical trial of the middle school version of the Keep Safe intervention in a sample of girls in foster care ( n  = 100). The intervention was delivered to girls and foster parents during the transition to middle school. Path analysis suggested a significant intervention effect on reduction in affiliation with delinquent peers at 12 months ( B  = -.21). No significant mediation effects were identified. The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior. Implications for researchers and professionals who tailor and deliver evidence-based programs for girls in foster care are discussed.",2020,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","['adolescents with juvenile justice histories', 'Girls in Foster Care', 'girls with foster care histories', 'sample of girls in foster care ( n  = 100']",['middle school version of the Keep Safe intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0599066,"The middle school Keep Safe intervention shows promise as a preventative intervention for reducing affiliation with delinquent peers, which importantly is associated with adolescent delinquent behavior.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Hu', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Van Ryzin', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Schweer-Collins', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Leslie D', 'Initials': 'LD', 'LastName': 'Leve', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}]",Child maltreatment,['10.1177/1077559520923033']
63,32385848,"Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status Among Parents of American Indian Newborns.","OBJECTIVE


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


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


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


HL was associated with parental oral health knowledge, beliefs, and self-reported OHS. Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.",2020,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"['Participants were recruited in parent-child dyads (N\u2009=\u2009579', 'parents with more limited HL skills', 'with parents of AI newborns', 'Parents of American Indian Newborns', 'parents of American Indian (AI) children']",['oral health intervention'],"['sociodemographic characteristics, HL, and parental oral health knowledge, beliefs, behavior, and self-reported OHS', 'health literacy (HL) and parental oral health knowledge, beliefs, behavior, and self-reported oral health status (OHS', 'Health Literacy and Parental Oral Health Knowledge, Beliefs, Behavior, and Status']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0459279,Oral health education interventions targeting AI families should facilitate development of knowledge and positive oral health beliefs among parents with more limited HL skills.,"[{'ForeName': 'Angela G', 'Initials': 'AG', 'LastName': 'Brega', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA. angela.brega@cuanschutz.edu.'}, {'ForeName': 'Luohua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Medicine, University of California Irvine, 205B Irvine Hall, Irvine, CA, 92697, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Johnson', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatric Dentistry, School of Dental Medicine, University of Colorado Anschutz Medical Campus, 13123 East 16th Avenue, Aurora, CO, 80045, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place, Aurora, CO, 80045, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Albino', 'Affiliation': 'Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13055 East 17th Avenue, Aurora, CO, 80045, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00688-4']
64,32399899,Forced Expiratory Flow (FEF 25-75% ) as a Clinical Endpoint in Children and Adolescents with Symptomatic Asthma Receiving Tiotropium: A Post Hoc Analysis.,"INTRODUCTION


In pediatric patients with asthma, measurements of forced expiratory volume in 1 s (FEV 1 ) may be normal or may not correlate with symptom severity. Forced expiratory flow at 25-75% of the vital capacity (FEF 25-75% ) is a potentially more sensitive parameter for assessing peripheral airway function. This post hoc analysis compared FEF 25-75%  with FEV 1  as an endpoint to assess bronchodilator responsiveness in children with asthma.
METHODS


Change from baseline in trough FEF 25-75%  and trough FEV 1  following treatment with either tiotropium (5 µg or 2.5 µg) or placebo Respimat ®  was analyzed in four phase III trials in children (aged 6-11 years) and adolescents (aged 12-17 years) with symptomatic moderate (VivaTinA-asthma ®  and PensieTinA-asthma ® ) and mild (CanoTinA-asthma ®  and RubaTinA-asthma ® ) asthma. Data from all treatment arms were pooled and correlations between FEF 25-75%  and FEV 1  were calculated and analyzed.
RESULTS


A total of 1590 patients were included in the analysis. Tiotropium Respimat ®  consistently improved FEF 25-75%  and FEV 1  versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant. Improvements in FEF 25-75%  response with tiotropium versus placebo were largely more pronounced than improvements in FEV 1 . Statistical assessment of the correlation of FEV 1  and FEF 25-75%  showed moderate-to-high correlations (Pearson's correlation coefficients 0.73-0.80).
CONCLUSIONS


In pediatric patients, FEF 25-75%  may be a more sensitive measure to detect treatment response, certainly to tiotropium, than FEV 1  and should be evaluated as an additional lung function measurement.",2020,"Tiotropium Respimat ®  consistently improved FEF 25-75%  and FEV 1  versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant.","['Change from baseline in trough FEF 25-75%  and trough', 'pediatric patients with asthma', 'children (aged 6-11\xa0years) and adolescents (aged 12-17\xa0years) with symptomatic moderate (VivaTinA-asthma ®  and PensieTinA-asthma ® ) and mild (CanoTinA-asthma ®  and RubaTinA-asthma ® ) asthma', 'children with asthma', 'A total of 1590 patients were included in the analysis', 'Children and Adolescents with Symptomatic Asthma Receiving']","['placebo', 'placebo Respimat ®', 'Tiotropium', 'tiotropium']","['bronchodilator responsiveness', 'forced expiratory volume', 'Forced Expiratory Flow', 'FEF', 'Forced expiratory flow']","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}]",1590.0,0.229548,"Tiotropium Respimat ®  consistently improved FEF 25-75%  and FEV 1  versus placebo, although in adolescents with severe asthma, the observed improvements were not statistically significant.","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, The Breathing Institute, Children's Hospital of Colorado, University of Colorado School of Medicine, Aurora, CO, USA. stanley.szefler@childrenscolorado.org.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Goldstein', 'Affiliation': 'Allergy and Asthma Care of Long Island, Rockville Centre, NY, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vogelberg', 'Affiliation': 'University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Bensch', 'Affiliation': 'Allergy, Immunology and Asthma Medical Group, Inc., Stockton, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Given', 'Affiliation': 'Allergy and Respiratory Center, Canton, OH, USA.'}, {'ForeName': 'Branko', 'Initials': 'B', 'LastName': 'Jugovic', 'Affiliation': 'TA Respiratory Diseases/Biosimilars Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Engel', 'Affiliation': 'TA Respiratory Diseases/Biosimilars Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Petra M', 'Initials': 'PM', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty Ltd, Sydney, NSW, Australia.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sigmund', 'Affiliation': 'Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG., Biberach an der Riss, Germany.'}, {'ForeName': 'Eckard H', 'Initials': 'EH', 'LastName': 'Hamelmann', 'Affiliation': 'Klinik für Kinder- Und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Klinikum Bethel EvKB, Bielefeld, Germany.'}]",Pulmonary therapy,['10.1007/s41030-020-00117-6']
65,32400000,"A Multicenter Randomized Three-Arm Phase II Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) with Leuprolide + Letrozole, and (3) Everolimus + EDT in Patients with Unresectable Fibrolamellar Carcinoma.","LESSONS LEARNED


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


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


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


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


Neither EDT nor mTOR inhibition improved outcomes in FLC. Other treatment strategies are needed.",2020,"Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort.","['Patients with Unresectable Fibrolamellar Carcinoma', 'advanced fibrolamellar carcinoma', 'Twenty-eight patients were enrolled', 'Patients']","['Everolimus, (2) Estrogen Deprivation Therapy (EDT) with Leuprolide + Letrozole, and (3) Everolimus + EDT', 'everolimus/letrozole/leuprolide', 'Estrogen deprivation therapy with letrozole and leuprolide, alone or in combination with the mTOR inhibitor, everolimus', 'everolimus), arm B (letrozole/leuprolide; estrogen deprivation therapy [EDT]), or arm C (everolimus/letrozole/leuprolide', 'FLC']","['Stable disease', 'overexpression of mTOR and S6 kinase', 'elevated aspartate transaminase', 'vomiting', 'anemia', 'nausea', 'Median overall survival (OS', 'Grade 3 adverse events', ""progression-free survival (PFS) at 6 months (PFS6) assessed using a Simon's minimax two-stage design, hypothesizing an improvement in PFS6"", 'alanine transaminase (ALT; 36%), and alkaline phosphatase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334287', 'cui_str': 'Hepatocellular carcinoma, fibrolamellar'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0334287', 'cui_str': 'Hepatocellular carcinoma, fibrolamellar'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0073337', 'cui_str': 'Ribosomal Protein S6 Kinase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0220989', 'cui_str': 'Acquired partial lipodystrophy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}]",28.0,0.0597627,"Median overall survival (OS) was 12.4 months (95% confidence interval [CI], 7.4-20.9) for the whole study cohort.","[{'ForeName': 'Imane', 'Initials': 'I', 'LastName': 'El Dika', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Marinela', 'Initials': 'M', 'LastName': 'Capanu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaQuaglia', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Allison F', 'Initials': 'AF', 'LastName': ""O'Neill"", 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ly', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Ang', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Gordan', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0367']
66,32382924,The effect of pre-anesthesia with a needle-free system versus topical anesthesia on injection pain of the inferior alveolar nerve block: a randomized clinical trial.,"OBJECTIVE


The aim of this study was to compare the effectiveness of pain control between a needle-free system and topical anesthesia applied prior to inferior alveolar nerve block (IANB).
MATERIALS AND METHODS


The present study was designed as a randomized controlled cross-over clinical study on 60 children (aged 6 to 12 years) requiring dental treatment with IANB in bilateral mandibular molars. As pre-anesthesia, topical anesthesia (TA) was applied on one side and the Comfort-in™ injection system (CIS) on the other side in two separate sessions before IANB. The injection pain during IANB, at both the needle insertion and solution deposition phases, was analyzed using the Wong-Baker Faces Pain Rating Scale (PRS) and the Face, Legs, Activity, Cry, Consolability Scale (FLACC). The data were analyzed using the Wilcoxon signed-rank test, Spearman correlation, and Mann-Whitney U test.
RESULTS


There were statistically significant differences between TA and CIS in subjective and objective pain evaluations during both the needle insertion and solution deposition. The use of a needle-free system in pre-anesthesia yielded a significant decrease in subjective and objective pain scores (p < 0.001). No statistical difference was found between TA and CIS in terms of patient preference, but patient preference for CIS was significantly higher in older patients (p < 0.01).
CONCLUSIONS


It was determined that the use of a needle-free system in pre-anesthesia yielded a decrease in injection pain of IANB.
CLINICAL RELEVANCE


Pediatric dentists should be aware of the new injection system in order to decrease the level of injection pain.",2020,There were statistically significant differences between TA and CIS in subjective and objective pain evaluations during both the needle insertion and solution deposition.,"['60 children (aged 6 to 12\xa0years) requiring dental treatment with IANB in bilateral mandibular molars', 'Pediatric dentists']","['pre-anesthesia with a needle-free system versus topical anesthesia', 'topical anesthesia (TA']","['Baker Faces Pain Rating Scale (PRS) and the Face, Legs, Activity, Cry, Consolability Scale (FLACC', 'subjective and objective pain scores', 'TA and CIS in subjective and objective pain evaluations', 'patient preference for CIS', 'injection pain of IANB']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0586985', 'cui_str': 'Pedodontist'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}]",60.0,0.0552679,There were statistically significant differences between TA and CIS in subjective and objective pain evaluations during both the needle insertion and solution deposition.,"[{'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Yıldırım', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul Okan University, Istanbul, Turkey. sinemfilizz@hotmail.com.'}, {'ForeName': 'Müge', 'Initials': 'M', 'LastName': 'Tokuç', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul Okan University, Istanbul, Turkey.'}, {'ForeName': 'Merve Nur', 'Initials': 'MN', 'LastName': 'Aydın', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul Okan University, Istanbul, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03301-9']
67,32382926,Low-power laser and potassium oxalate gel in the treatment of cervical dentin hypersensitivity-a randomized clinical trial.,"OBJECTIVE


To evaluate the effectiveness of different protocols for the treatment of cervical dentin hypersensitivity (CDH) in non-carious cervical lesions (NCCLs).
MATERIALS AND METHODS


The CONSORT checklist was used to design this study. The sample with n = 74 participants (389 NCCLs) was randomly allocated into three groups: G1, potassium oxalate (Oxa-Gel BF); G2, GaAlAs (gallium-aluminum-arsenate) low-power laser (100 mW, 808nn, 60 J/cm 2 ); and G3, potassium oxalate (Oxa-Gel BF) associated with the GaAlAs low-power laser. The CDH was triggered by the evaporative stimulus test (EST) and by the tactile stimulus test (TST). The visual analog scale (VAS) was used to quantify the degree of CDH. Changes in sensitivity were assessed from baseline over 3 weeks. Data were analyzed for NCCLs using mixed-effects models with unstructured direct product covariance structure (α = 0.05).
RESULTS


After the first application, participants from G1 and G3 had a reduction in CDH (p < 0.05) compared with group G2 for TST. After the second application, G3 participants had a reduction in CDH (p < 0.05) in relation to G2 for both stimuli. Reduction in CDH (p < 0.05) occurred over 3 weeks for EST and TST for all groups; however, there was no difference between groups at the end of the therapies.
CONCLUSION


Potassium oxalate was more effective in reducing immediate CDH. After four applications, all groups showed similar results for the reduction of CDH.
CLINICAL RELEVANCE


GaAlAS laser irradiation and oxalate potassium gel could reduce the symptoms of CDH; thus, they are viable alternatives for the treatment of this condition. Chemical occlusion of dental tubules showed effective results after a shorter time interval.
TRIAL REGISTRATION


Brazilian Clinical Trials Registration Platform under protocol number RBR-4ybjmt. http://www.braziliantrials.com/?keywords=RBR-4ybjmt&order=%7Eensaios.patrocinador_primario.",2020,"Reduction in CDH (p < 0.05) occurred over 3 weeks for EST and TST for all groups; however, there was no difference between groups at the end of the therapies.
","['non-carious cervical lesions (NCCLs', 'sample with n\u2009=\u200974 participants (389 NCCLs']","['G1, potassium oxalate (Oxa-Gel BF); G2, GaAlAs (gallium-aluminum-arsenate) low-power laser', 'Low-power laser and potassium oxalate gel', 'G3, potassium oxalate (Oxa-Gel BF) associated with the GaAlAs low-power laser', 'oxalate potassium gel']","['reduction of CDH', 'visual analog scale (VAS', 'Reduction in CDH', 'CDH', 'immediate CDH', 'cervical dentin hypersensitivity (CDH', 'Changes in sensitivity']","[{'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517752', 'cui_str': '389'}]","[{'cui': 'C0032837', 'cui_str': 'Potassium oxalate'}, {'cui': 'C1173234', 'cui_str': 'oxa-gel'}, {'cui': 'C0016980', 'cui_str': 'Gallium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0003816', 'cui_str': 'Arsenates'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0029988', 'cui_str': 'Oxalate'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0410888,"Reduction in CDH (p < 0.05) occurred over 3 weeks for EST and TST for all groups; however, there was no difference between groups at the end of the therapies.
","[{'ForeName': 'Paula Cesar', 'Initials': 'PC', 'LastName': 'Sgreccia', 'Affiliation': 'Faculty of Health Sciences, University of Brasilia, Brasília, Federal District, Brazil.'}, {'ForeName': 'Rodrigo Edson Santos', 'Initials': 'RES', 'LastName': 'Barbosa', 'Affiliation': 'Dental Prosthesis, Catholic University of Brasília, Brasília, Federal District, Brazil.'}, {'ForeName': 'Nailê', 'Initials': 'N', 'LastName': 'Damé-Teixeira', 'Affiliation': 'Department of Dentistry and Pos Graduate Program in Dentistry, Health Sciences School, University of Brasília, Campus Asa Norte, Brasilia, Federal District, 70904-970, Brazil.'}, {'ForeName': 'Fernanda Cristina Pimentel', 'Initials': 'FCP', 'LastName': 'Garcia', 'Affiliation': 'Department of Dentistry and Pos Graduate Program in Dentistry, Health Sciences School, University of Brasília, Campus Asa Norte, Brasilia, Federal District, 70904-970, Brazil. garciafcp@unb.br.'}]",Clinical oral investigations,['10.1007/s00784-020-03311-7']
68,32382928,Root fillings with a matched-taper single cone and two calcium silicate-based sealers: an analysis of voids using micro-computed tomography.,"OBJECTIVES


To compare the percentage of voids in matched-taper single-cone fillings with GuttaFlow Bioseal or BioRoot RCS root canal sealers, using micro-computed tomography.
MATERIALS AND METHODS


Forty-eight single-rooted mandibular premolars were prepared using rotary files and randomly allocated into 2 groups (n = 24), wherein the canals were filled with a matched-taper single gutta-percha cone and one of the two sealers: Group 1, GuttaFlow Bioseal and Group 2, BioRoot RCS. The specimens were scanned with micro-CT before and after root canal filling. A specialized software was used to calculate the voids volume percentage (V%) in the filling for the whole root canal, root canal thirds, and the last millimeter from the apex. Data were statistically analyzed by ANOVA and Tukey tests (p < 0.05).
RESULTS


Root canals filled with GuttaFlow Bioseal had significantly less V% than those filled with BioRoot RCS in all the root-thirds (p < 0.05) except at the apical 1 mm (p > 0.05). Comparing the root-thirds, GuttaFlow Bioseal showed similar V% in all regions (p > 0.05), while BioRoot RCS group had significantly greater V% in the coronal third compared with the other thirds (p < 0.05).
CONCLUSIONS


Root canals filled with a matched-taper single cone and GuttaFlow Bioseal had significant less voids than those with BioRoot RCS, except at the apical 1 mm.
CLINICAL RELEVANCE


Voids in root fillings have been reported to have a negative impact on root canal treatment. This study highlights the percentage of voids in root fillings composed of a single cone of gutta-percha with two types of calcium silicate-based bioceramic sealers.",2020,"RESULTS


Root canals filled with GuttaFlow Bioseal had significantly less V% than those filled with BioRoot RCS in all the root-thirds (p < 0.05) except at the apical 1 mm (p > 0.05).",['Forty-eight single-rooted mandibular premolars'],"['calcium silicate-based bioceramic sealers', 'GuttaFlow Bioseal or BioRoot RCS root canal sealers, using micro-computed tomography', 'calcium silicate-based sealers', 'GuttaFlow Bioseal and Group 2, BioRoot RCS']",[],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C1872787', 'cui_str': 'GuttaFlow'}, {'cui': 'C0385318', 'cui_str': 'Bioseal'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]",[],48.0,0.0239332,"RESULTS


Root canals filled with GuttaFlow Bioseal had significantly less V% than those filled with BioRoot RCS in all the root-thirds (p < 0.05) except at the apical 1 mm (p > 0.05).","[{'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Pedullà', 'Affiliation': 'Department of General Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Roula S', 'Initials': 'RS', 'LastName': 'Abiad', 'Affiliation': 'Endodontic Division, Faculty of Dentistry, Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Conte', 'Affiliation': 'Department of General Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Giusy R M', 'Initials': 'GRM', 'LastName': 'La Rosa', 'Affiliation': 'Department of General Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rapisarda', 'Affiliation': 'Department of General Surgery and Medical-Surgical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Neelakantan', 'Affiliation': 'Discipline of Endodontology, Faculty of Dentistry, The University of Hong Kong, The Prince Philip Dental Hospital, 34, Hospital Road, Sai Ying Pun, Hong Kong SAR. prasanna@hku.hk.'}]",Clinical oral investigations,['10.1007/s00784-020-03313-5']
69,32386810,Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial.,"PURPOSE


To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).
DESIGN


Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).
PARTICIPANTS


Seven hundred eighty-five patients with age-related cataract.
METHODS


This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.
MAIN OUTCOME MEASURES


We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.
CONCLUSIONS


Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.",2020,"There were no significant differences between arms for any secondary outcome.
","['Seven hundred eighty-five patients with age-related cataract', '785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS', '3 hospitals in the UK National Health Service (NHS']","['standard phacoemulsification cataract surgery (PCS', 'Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT', 'Femtosecond Laser-Assisted Cataract Trial [FACT', 'femtosecond laser-assisted cataract surgery (FLACS', 'Femtosecond laser-assisted cataract surgery']","['clinical effectiveness and cost-effectiveness', 'unaided distance visual acuity (UDVA', 'mean UDVA difference', 'corrected distance visual acuity, complications, and patient-reported outcomes measures', 'mean corrected distance visual acuity difference']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",785.0,0.436528,"There were no significant differences between arms for any secondary outcome.
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Day', 'Affiliation': 'The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom; UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: alex.day@ucl.ac.uk.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Burr', 'Affiliation': 'School of Medicine, University of St. Andrews, Fife, Scotland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, United Kingdom.'}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Department of Primary Care & Public Health Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'UCL Comprehensive Clinical Trials Unit, London, United Kingdom.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Rubin', 'Affiliation': 'UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Mayank A', 'Initials': 'MA', 'LastName': 'Nanavaty', 'Affiliation': 'Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, United Kingdom.'}, {'ForeName': 'Kamaljit S', 'Initials': 'KS', 'LastName': 'Balaggan', 'Affiliation': 'Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, West Midlands, United Kingdom.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Wilkins', 'Affiliation': 'The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.02.028']
70,32386811,Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty: A Multicenter Randomized Controlled Clinical Trial.,"PURPOSE


To compare best spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK).
DESIGN


Prospective, multicenter randomized controlled trial.
PARTICIPANTS


Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands.
METHODS


Participants were allocated to DMEK (n = 29) or UT-DSAEK (n = 25) using minimization randomization based on preoperative BSCVA, recipient central corneal thickness, gender, age, and institution. Donor corneas were prestripped and precut for DMEK and UT-DSAEK, respectively. Six corneal surgeons participated in this study.
MAIN OUTCOME MEASURES


The primary outcome measure was BSCVA at 12 months after surgery.
RESULTS


Central graft thickness of UT-DSAEK lamellae measured 101 μm (95% confidence interval [CI], 90-112 μm). Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR] [95% CI 0.08-0.22 logMAR] vs. 0.22 logMAR [95% CI 0.16-0.27 logMAR]; P = 0.15), 6 months (0.11 logMAR [95% CI 0.05-0.17 logMAR] vs. 0.16 logMAR [95% CI 0.12-0.21 logMAR]; P = 0.20), and 12 months (0.08 logMAR [95% CI 0.03-0.14 logMAR] vs. 0.15 logMAR [95% CI 0.10-0.19 logMAR]; P = 0.06). Twelve months after surgery, the percentage of eyes reaching 20/25 Snellen BSCVA was higher in DMEK compared with UT-DSAEK (66% vs. 33%; P = 0.02). Endothelial cell density did not differ significantly 12 months after DMEK and UT-DSAEK (1870 cells/mm 2  [95% CI 1670-2069 cells/mm 2 ] vs. 1612 cells/mm 2  [95% CI 1326-1898 cells/mm 2 ]; P = 0.12). Both techniques induced a mild hyperopic shift (12 months: +0.22 diopter [D; 95% CI -0.23 to 0.68 D] for DMEK vs. +0.58 D [95% CI 0.13-1.03 D] for UT-DSAEK; P = 0.34).
CONCLUSIONS


Descemet membrane endothelial keratoplasty and UT-DSAEK did not differ significantly in mean BSCVA, but the percentage of eyes achieving 20/25 Snellen vision was significantly higher with DMEK. Endothelial cell loss did not differ significantly between the treatment groups, and both techniques induced a minimal hyperopic shift.",2020,Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR],"['Six corneal surgeons participated in this study', 'Fifty-four pseudophakic eyes of 54 patients with corneal endothelial dysfunction resulting from Fuchs endothelial corneal dystrophy were enrolled in 6 corneal centers in The Netherlands', 'Participants were allocated to DMEK (n\xa0= 29) or']","['UT-DSAEK', 'Descemet Membrane Endothelial Keratoplasty versus Ultrathin Descemet Stripping Automated Endothelial Keratoplasty']","['Endothelial cell loss', 'mild hyperopic shift', 'Best spectacle-corrected visual acuity', 'BSCVA at 12 months after surgery', 'percentage of eyes achieving 20/25 Snellen vision', 'percentage of eyes reaching 20/25 Snellen BSCVA', 'spectacle-corrected visual acuity (BSCVA), endothelial cell density (ECD), refractive astigmatism, and complications after Descemet membrane endothelial keratoplasty (DMEK) and ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK', 'Endothelial cell density']","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}]","[{'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4302773', 'cui_str': ""Descemet's membrane endothelial keratoplasty""}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}]",54.0,0.324218,Best spectacle-corrected visual acuity did not differ significantly between DMEK and UT-DSAEK groups at 3 months (0.15 logarithm of the minimum angle of resolution [logMAR],"[{'ForeName': 'Suryan L', 'Initials': 'SL', 'LastName': 'Dunker', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands. Electronic address: suryan.dunker@mumc.nl.'}, {'ForeName': 'Mor M', 'Initials': 'MM', 'LastName': 'Dickman', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Robert P L', 'Initials': 'RPL', 'LastName': 'Wisse', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Nobacht', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert H J', 'Initials': 'RHJ', 'LastName': 'Wijdh', 'Affiliation': 'Department of Ophthalmology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marjolijn C', 'Initials': 'MC', 'LastName': 'Bartels', 'Affiliation': 'Department of Ophthalmology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Mei L', 'Initials': 'ML', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology, Gelre Hospitals, Apeldoorn, The Netherlands.'}, {'ForeName': 'Frank J H M', 'Initials': 'FJHM', 'LastName': 'van den Biggelaar', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Kruit', 'Affiliation': 'Euro Tissue Bank - Bio Implant Service (ETB-BISLIFE), Leiden, The Netherlands.'}, {'ForeName': 'Rudy M M A', 'Initials': 'RMMA', 'LastName': 'Nuijts', 'Affiliation': 'University Eye Clinic, Maastricht University Medical Center, Maastricht, The Netherlands; Department of Ophthalmology, Zuyderland Medical Center, Heerlen, The Netherlands.'}]",Ophthalmology,['10.1016/j.ophtha.2020.02.029']
71,32394219,The Effects of Acceptance and Commitment Therapy (ACT) Intervention on Inflammation and Stress Biomarkers: a Randomized Controlled Trial.,"BACKGROUND


Psychological processes can be manifested in physiological health. We investigated whether acceptance and commitment therapy (ACT), targeted on psychological flexibility (PF), influences inflammation and stress biomarkers among working-age adults with psychological distress and overweight/obesity.
METHOD


Participants were randomized into three parallel groups: (1) ACT-based face-to-face (n = 65; six group sessions led by a psychologist), (2) ACT-based mobile (n = 73; one group session and mobile app), and (3) control (n = 66; only the measurements). Systemic inflammation and stress markers were analyzed at baseline, at 10 weeks after the baseline (post-intervention), and at 36 weeks after the baseline (follow-up). General PF and weight-related PF were measured with questionnaires (Acceptance and Action Questionnaire, Acceptance and Action Questionnaire for Weight-Related Difficulties).
RESULTS


A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers. hsCRP decreased significantly in the face-to-face group from week 0 to week 36, and at week 36, hsCRP was lower among the participants in the face-to-face group than in the mobile group (p = .035, post hoc test). Age and sex were stronger predictors of biomarker levels at follow-up than the post-intervention PF.
CONCLUSION


The results suggest that ACT delivered in group sessions may exert beneficial effects on low-grade systemic inflammation. More research is needed on how to best apply psychological interventions for the health of both mind and body among people with overweight/obesity and psychological distress.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01738256, Registered 17 August, 2012.",2020,A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers.,"['Participants', 'working-age adults with psychological distress and overweight/obesity', 'people with overweight/obesity and psychological distress']","['acceptance and commitment therapy (ACT', 'ACT-based face-to-face (n\u2009=\u200965; six group sessions led by a psychologist), (2) ACT-based mobile (n\u2009=\u200973; one group session and mobile app', 'Acceptance and Commitment Therapy (ACT) Intervention', 'ACT']","['hsCRP', 'Inflammation and Stress Biomarkers', 'high-sensitivity C-reactive protein (hsCRP) level', 'General PF and weight-related PF', 'low-grade systemic inflammation', 'questionnaires (Acceptance and Action Questionnaire, Acceptance and Action Questionnaire for Weight-Related Difficulties', 'Systemic inflammation and stress markers']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.112618,A group × time interaction (p = .012) was detected in the high-sensitivity C-reactive protein (hsCRP) level but not in other inflammation and stress biomarkers.,"[{'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Järvelä-Reijonen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland. elina.jarvela-reijonen@uef.fi.'}, {'ForeName': 'Sampsa', 'Initials': 'S', 'LastName': 'Puttonen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O. Box 40, FI-00251, Helsinki, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karhunen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Essi', 'Initials': 'E', 'LastName': 'Sairanen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Laitinen', 'Affiliation': 'Finnish Institute of Occupational Health, P.O. Box 40, FI-00251, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Department of Environmental and Biological Sciences, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Pihlajamäki', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Korpela', 'Affiliation': 'Medical Faculty, Pharmacology, Medical Nutrition Physiology and Human Microbe Research Program, University of Helsinki, P.O. Box 63, FI-00014, Helsinki, Finland.'}, {'ForeName': 'Miikka', 'Initials': 'M', 'LastName': 'Ermes', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, P.O. Box 35, FI-40014, Jyväskylä, Finland.'}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, FI-70211, Kuopio, Finland.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09891-8']
72,32398077,Effect of a postpartum family planning intervention on postpartum intrauterine device counseling and choice: evidence from a cluster-randomized trial in Tanzania.,"BACKGROUND


The World Health Organization recommends postpartum family planning (PPFP) for healthy birth spacing. This study is an evaluation of an intervention that sought to improve women's access to PPFP in Tanzania. The intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services for women electing PPIUD in the immediate postpartum period.
METHODS


This cluster-randomized controlled trial recruited 15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016. We present the effectiveness of the intervention using a difference-in-differences approach to compare outcomes, receipt of PPIUD counseling and choice of PPIUD after delivery, between the pre- and post-intervention period in the treatment and control group. We also present an intervention adherence-adjusted analysis using an instrumental variables estimation.
RESULTS


We estimate linear probability models to obtain effect sizes in percentage points (pp). The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp). The adherence-adjusted estimates demonstrate that if all women had been counseled, we would have observed a 31.6 pp increase in choice of PPIUD (95% CI: 24.3 - 35.8 pp). Among women counseled, determinants of choosing PPIUD included receiving an informational leaflet during counseling and being counseled after admission for delivery services.
CONCLUSIONS


The intervention modestly increased the rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling among women delivering in study facilities. With universal PPIUD counseling, large increases in choice of PPIUD would have been observed. Giving women informational materials on PPIUD and counseling after admission for delivery are likely to increase the proportion of women choosing PPIUD.
TRIAL REGISTRATION


Registered with clinicaltrials.gov (NCT02718222) on March 24, 2016, retrospectively registered.",2020,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"['15,264 postpartum Tanzanian women aged 18 or older who delivered in one of five study hospitals between January and September 2016', 'healthy birth spacing', ""women's access to PPFP in Tanzania""]","['intervention included counseling on PPFP during antenatal and delivery care and introducing postpartum intrauterine device (PPIUD) insertion as an integrated part of delivery services', 'postpartum family planning intervention']","['rate of PPIUD counseling and choice of PPIUD, primarily due to low coverage of PPIUD counseling', 'PPIUD counseling']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",15264.0,0.213227,The intervention increased PPIUD counseling by 19.8 pp (95% CI: 9.1 - 22.6 pp) and choice of PPIUD by 6.3 pp (95% CI: 2.3 - 8.0 pp).,"[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Pearson', 'Affiliation': 'Ipas, Chapel Hill, NC, USA. pearsone@ipas.org.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Senderowicz', 'Affiliation': 'University of Wisconsin - Madison School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pradhan', 'Affiliation': 'World Bank, Washington, DC, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Family Medicine and Primary Care, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Projestine', 'Initials': 'P', 'LastName': 'Muganyizi', 'Affiliation': 'Association of Gynaecologists and Obstetricians of Tanzania (AGOTA), Dar es Salaam, Tanzania.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Shah', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",BMC women's health,['10.1186/s12905-020-00956-0']
73,32336008,A randomised Phase II trial of carboplatin and gemcitabine ± vandetanib in first-line treatment of patients with advanced urothelial cell cancer not suitable to receive cisplatin.,"OBJECTIVES


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


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


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


There is no evidence that vandetanib improves clinical outcome in this setting. Our present data do not support its adoption as the regimen of choice for first-line treatment in patients with UC who were unfit for cisplatin.",2020,Toxicity ≥grade 3 was experienced in 80% (n=32) and 76% (n=32) of patients on vandetanib and placebo arms respectively.,"['UC patients who were unfit for cisplatin', '25 patients (30%) completed 6 cycles of all allocated treatment', 'Eighty-two patients', 'patients with advanced urolthelial cancer (UC) who were unsuitable for cisplatin', 'From 2011 and 2014', 'advanced urothelial cell cancer patients', '82 patients were randomised from 16 hospitals across the UK into the TOUCAN double-blind']","['oral vandetanib 100mg or placebo', 'carboplatin and gemcitabine ', 'dual EGFR/VEGFR inhibitor, vandetanib, in combination with carboplatin and gemcitabine', 'placebo', 'cisplatin', 'vandetanib', 'intravenous carboplatin (AUC 4.5 day 1) and gemcitabine']","['efficacy and tolerability', 'radiological response rates', 'Progression-free survival (PFS - primary endpoint), adverse events (AEs), tolerability and feasibility of use, objective response rate and overall survival (OS', 'Median PFS']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0227599', 'cui_str': 'Urinary tract transitional epithelial cell'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2960054', 'cui_str': 'Ramphastinae'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3152967', 'cui_str': 'Vandetanib 100 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121849', 'cui_str': 'Vandetanib'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",82.0,0.528557,Toxicity ≥grade 3 was experienced in 80% (n=32) and 76% (n=32) of patients on vandetanib and placebo arms respectively.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chester', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elliott', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Royal Lancaster Infirmary, Lancaster, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Satinder', 'Initials': 'S', 'LastName': 'Jagdev', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tracie-Ann', 'Initials': 'TA', 'LastName': 'Madden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}]",BJU international,['10.1111/bju.15096']
74,32376981,Longitudinal follow-up after telephone disclosure in the randomized COGENT study.,"PURPOSE


To better understand the longitudinal risks and benefits of telephone disclosure of genetic test results in the era of multigene panel testing.
METHODS


Adults who were proceeding with germline cancer genetic testing were randomized to telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD) (i.e., usual care) of test results. All participants who received TD were recommended to return to meet with a physician to discuss medical management recommendations.
RESULTS


Four hundred seventy-three participants were randomized to TD and 497 to IPD. There were no differences between arms for any cognitive, affective, or behavioral outcomes at 6 and 12 months. Only 50% of participants in the TD arm returned for the medical follow-up appointment. Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002). Mammography was lower at 12 months among those who had TD and did not return for medical follow-up (70%) compared with those who had TD and returned (86%) and those who had IPD (87%, adjusted p < 0.01).
CONCLUSION


Telephone disclosure of genetic test results is a reasonable alternative to in-person disclosure, but attention to medical follow-up may remain important for optimizing appropriate use of genetic results.",2020,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","['Four hundred seventy-three participants were randomized to TD and 497 to IPD', 'Adults who were proceeding with germline cancer genetic testing']","['telephone disclosure (TD) with a genetic counselor or in-person disclosure (IPD)\xa0(i.e., usual care']","['cognitive, affective, or behavioral outcomes', 'Mammography']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",473.0,0.0669023,"Returning was associated with site (p < 0.0001), being female (p = 0.047), and not having a true negative result (p < 0.002).","[{'ForeName': 'Madison K', 'Initials': 'MK', 'LastName': 'Kilbride', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Egleston', 'Affiliation': 'Fox Chase Cancer Center, Temple University Health System, Biostatistics and Bioinformatics Facility, Philadelphia, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Patrick-Miller', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Daly', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ganschow', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Generosa', 'Initials': 'G', 'LastName': 'Grana', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Olufunmilayo I', 'Initials': 'OI', 'LastName': 'Olopade', 'Affiliation': 'Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fetzer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Chambers', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dana F', 'Initials': 'DF', 'LastName': 'Clark', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Forman', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Rikki', 'Initials': 'R', 'LastName': 'Gaber', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Gulden', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Horte', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Long', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Shreshtha', 'Initials': 'S', 'LastName': 'Madaan', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mattie', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McKenna', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Powers', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rainey', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rybak', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Savage', 'Affiliation': 'Department of Medical Genetics, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Seelaus', 'Affiliation': 'Department of Internal Medicine, The John H. Stroger Jr. Hospital of Cook County, Chicago, IL, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Stoll', 'Affiliation': 'Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Stopfer', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Xinxin Shirley', 'Initials': 'XS', 'LastName': 'Yao', 'Affiliation': 'Division of Hematology-Oncology, MD Anderson Cancer Center at Cooper, Camden, NJ, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Bradbury', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA. Angela.Bradbury@uphs.upenn.edu.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-020-0808-3']
75,32390720,Effects of an Impulse Frequency Dependent 10-Week Whole-body Electromyostimulation Training Program on Specific Sport Performance Parameters.,"The difference in the efficacy of altered stimulation parameters in whole-body-electromyostimulation (WB-EMS) training remains largely unexplored. However, higher impulse frequencies (>50 Hz) might be most adequate for strength gain. The aim of this study was to analyze potential differences in sports-related performance parameters after a 10-week WB-EMS training with different frequencies. A total of 51 untrained participants (24.9 ± 3.9 years, 174 ± 9 cm, 72.4 ± 16.4 kg, BMI 23.8 ± 4.1, body fat 24.7 ± 8.1 %) was randomly divided into three groups: one inactive control group (CON) and two training groups. They completed a 10-week WB-EMS program of 1.5 sessions/week, equal content but different stimulation frequencies (training with 20 Hz (T20) vs. training with 85 Hz (T85)). Before and after intervention, all participants completed jumping (Counter Movement Jump (CMJ), Squat Jump (SJ), Drop Jump (DJ)), sprinting (5m, 10m, 30m), and strength tests (isometric trunk flexion/extension). One-way ANOVA was applied to calculate parameter changes. Post-hoc least significant difference tests were performed to identify group differences. Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85). A 10-week WB-EMS training leads to significant improvements of jump and strength parameters in untrained participants. No differences could be detected between the frequencies. Therefore, both stimulation frequencies can be regarded as adequate for increasing specific sport performance parameters. Further aspects as regeneration or long term effects by the use of different frequencies still need to be clarified.",2020,"Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85).","['51 untrained participants (24.9 ± 3.9 years, 174 ± 9 cm, 72.4 ± 16.4 kg, BMI 23.8 ± 4.1, body fat 24.7 ± 8.1 ', 'untrained participants']","['inactive control group (CON', 'Impulse Frequency Dependent 10-Week Whole-body Electromyostimulation Training Program', 'jumping (Counter Movement Jump (CMJ), Squat Jump (SJ), Drop Jump (DJ']","['trunk flexion', 'Specific Sport Performance Parameters', 'jump and strength parameters']","[{'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517875', 'cui_str': '8.1'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",51.0,0.012783,"Significant differences were identified for CMJ (p = 0.007), SJ (p = 0.022), trunk flexion (p = 0.020) and extension (p=.013) with significant group differences between both training groups and CON (not between the two training groups T20 and T85).","[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ludwig', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Backfisch', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}]",Journal of sports science & medicine,[]
76,32390721,Acute Maltodextrin Supplementation During Resistance Exercise.,"Most of the research investigating the ergogenic enhancing mechanisms of carbohydrate have been conducted using aerobic based exercise. Therefore, the purpose of this study was to investigate the effects of pre-exercise maltodextrin ingestion on resistance exercise performance, serum insulin, epinephrine, glucose, and muscle glycogen concentrations. In a double blind, cross over, repeated measures design, participants completed four sets to failure at 70% of 1-RM with 45s rest on the angled leg press with or without pre-exercise maltodextrin (2g/kg) after a 3hr fast. Serum glucose, epinephrine, and insulin were assessed at baseline, 30 min post-ingestion, immediately after, and 1hr post-exercise with or without carbohydrate supplementation. Muscle glycogen was assessed from biopsy specimens sampled from the vastus lateralis before supplementation, immediately after exercise, and 1hr post exercise under both conditions. There was no main effect of supplement on resistance exercise performance (p = 0.18). Muscle glycogen concentration decreased across time for both groups (p < 0.001). There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026). An interaction occurred showing insulin decreased during exercise in the carbohydrate condition (p = 0.003). Also, there was a main effect of insulin being elevated with carbohydrate consumption (p = 0.027). Epinephrine was decreased across all time points after carbohydrate ingestion (p = 0.023). Carbohydrate supplementation before resistance exercise did not improve leg press performance to fatigue despite increased metabolic substrate availability. These results indicate that pre-exercise dietary carbohydrate will be utilized preferentially during exercise due to decreased epinephrine, decreased serum glucose, and increased insulin concentrations. However, the increases in glycolytic substrate availability will not increase exercise performance or glycogen content following 1hr of recovery.",2020,There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026).,[],"['Epinephrine', 'Carbohydrate supplementation before resistance exercise', '1-RM with 45s rest on the angled leg press with or without pre-exercise maltodextrin', 'pre-exercise maltodextrin ingestion', 'Acute Maltodextrin Supplementation']","['resistance exercise performance', 'Muscle glycogen', 'serum glucose', 'resistance exercise performance, serum insulin, epinephrine, glucose, and muscle glycogen concentrations', 'exercise performance or glycogen content', 'serum glucose, and increased insulin concentrations', 'Muscle glycogen concentration', 'Serum glucose, epinephrine, and insulin']",[],"[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0556103', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.109494,There was an interaction in serum glucose decreasing more during exercise in the carbohydrate condition (p = 0.026).,"[{'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Hwang', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Department of Health, Human Performance, and Recreation, Baylor University, Baylor University, Waco, TX USA.'}]",Journal of sports science & medicine,[]
77,32390724,One Session of Extracorporeal Shockwave Therapy-Induced Modulation on Tendon Shear Modulus is Associated with Reduction in Pain.,"The aim of the study was to examine the immediate effect of 1 session of extracorporeal shockwave therapy (ESWT) on patellar tendon stiffness and to explore the relationship between the change in tendon stiffness and the pain intensity. Thirty-four male athletes aged 22.2 ± 3.8 with patellar tendinopathy were recruited. The participants were randomized into ESWT and sham groups. The ESWT group received 1500 impulses of ESWT at 4 Hz with maximal tolerable pain intensity and the sham group received intensities below 0.08 mJ/mm 2 . Supersonic Shearwave Imaging (SSI) was used to measure tendon shear modulus (an index of tissue stiffness), and a visual analogue scale was used to quantify the pain intensity during compression with 10 lb (4.535 kg) pressure directed on the most tender part and then during a single-leg declined-squat test. A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06). In the ESWT group, the change in tendon shear modulus was associated with the change in the intensity of pain during single-legged declined-squat test (ρ = 0.55; p = 0.023) but not pressure pain (p > 0.05). These findings suggest that one session of ESWT induces reduction of tendon stiffness in volleyball and basketball players with patellar tendinopathy. The reduction in tendon stiffness is associated with reduction in pain during single-legged declined-squat test.",2020,"A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06).","['Thirty-four male athletes aged 22.2 ± 3.8 with patellar tendinopathy were recruited', 'volleyball and basketball players with patellar tendinopathy']","['ESWT', 'extracorporeal shockwave therapy (ESWT', 'Extracorporeal Shockwave Therapy-Induced Modulation', 'Supersonic Shearwave Imaging (SSI']","['pressure pain', 'patellar tendon stiffness', 'tendon shear modulus', 'change in tendon shear modulus', 'intensity of pain', 'pain', 'tendon stiffness', 'tendon stiffness and the pain intensity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",34.0,0.0444846,"A significant reduction in tendon shear modulus (from 57.4 ± 25.5 kPa to 40.6 ± 17.6kPa, p = 0.001) was detected in the ESWT receiving ESWT with an intensity from 0.13-0.33 mJ/mm 2  but not the sham group (from 47.7 ± 17.1 kPa to 41.0 ± 12.7 kPa; p = 0.06).","[{'ForeName': 'Zhi Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Wai Chun', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province, Luoyang, China.'}, {'ForeName': 'Siu Ngor', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Department of Rehabilitation Sciences, the Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of sports science & medicine,[]
78,32390725,Impact of Duration of Eccentric Movement in the One-Repetition Maximum Test Result in the Bench Press among Women.,"Scientific studies related to resistance training have considered many variables; however, the tempo of movement of particular repetitions is often neglected or not reported in resistance training practice and research. The aim of the study was to determine the effect of different duration of the eccentric (ECC) phase of movement on one-repetition maximum test (1RM) results during the bench press exercise (BP). Twenty-one strength trained females (age = 23.4 ± 2.2 years, body mass = 52.3 ± 6.7 kg), with a minimum one year of strength training experience took part in the study. The experiment was conducted following a randomized crossover design, where each participant completed the 1RM test in the BP with three different duration times of the ECC movement: 2/0/X, 4/0/X, 6/0/X. Concentric (CON) movement was performed with maximal velocity (X). The ANOVA with repeated measures were used to compare the differences between the analyzed variables. The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01). Therefore, the results indicated that the longer the duration of the ECC phase of movement, the greater the decrease in the result of the 1RM test. The 1RM test procedure should include information about the movement tempo used during the test protocol.",2020,The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01).,"['Women', 'Twenty-one strength trained females (age = 23.4 ± 2.2 years, body mass = 52.3 ± 6.7 kg), with a minimum one year of strength training experience took part in the study']",[],['maximal load in the 1RM test'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",21.0,0.0242881,The results of the study indicated the maximal load in the 1RM test was significantly higher during the BP with the 2/0/X tempo compared to 6/0/X (p < 0.01) and 4/0/X tempos (p < 0.01).,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mostowik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Filip', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Hajduk', 'Affiliation': 'Galen-Orthopaedics, 43-150 Bierun, ul Jerzego 6, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, Katowice, Poland.'}]",Journal of sports science & medicine,[]
79,32395828,Retention of basic suturing skills with brief or extended practice in veterinary students.,"OBJECTIVE


To evaluate the effect of practice duration on accuracy, retention, and confidence when learning how to tie basic surgical knots.
STUDY DESIGN


Prospective study.
SAMPLE POPULATION


Fifteen first-year veterinary students.
METHODS


Students were randomly assigned to a 2-week practice (TWP) or an 8-week practice (EWP) to learn how to tie surgeon's, strangle, and miller's knots. Students' knot-tying accuracy and confidence were evaluated immediately after training, at an intermediate time point (2-6 weeks postpractice), and at 12 weeks postpractice.
RESULTS


Students who had been trained during an extended period tied the strangle knot correctly more often at all assessments (P = .025). The ability of students trained for 2 weeks to tie the strangle knot correctly decreased over time (P = .028). These students lost some confidence (P = .03) and repositioned suture more frequently (P = .03) while constructing the strangle knot at the final time point compared with students trained for 8 weeks. Students who completed TWP felt more confident at placing surgeon's knots than friction knots at the final assessment period (P = .0164 miller's knot, P = .0056 strangle knot), whereas confidence did not differ between knot types for students who completed EWP. All students felt less confident with their knot-tying skills at 12 weeks postpractice.
CONCLUSION


Training for 8 weeks rather than for 2 weeks resulted in superior knot tying skills. Students' confidence decreased 12 weeks after training.
CLINICAL SIGNIFICANCE


Prolonged distributed practice is recommended to train students for more complex tasks such as placement of a strangle knot.",2020,These students lost some confidence (P = .03) and repositioned suture more frequently (P = .03) while constructing the strangle knot at the final time point compared with students trained for 8 weeks.,"['Students', 'veterinary students', 'Fifteen first-year veterinary students']","[""2-week practice (TWP) or an 8-week practice (EWP) to learn how to tie surgeon's, strangle, and miller's knots""]",['superior knot tying skills'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0560032', 'cui_str': 'knot'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0560032', 'cui_str': 'knot'}]",,0.0300033,These students lost some confidence (P = .03) and repositioned suture more frequently (P = .03) while constructing the strangle knot at the final time point compared with students trained for 8 weeks.,"[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shaver', 'Affiliation': 'Department of Specialty Medicine, College of Veterinary Medicine, Midwestern University, Glendale, Arizona.'}, {'ForeName': 'Nalani', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'College of Veterinary Medicine, Midwestern University, Glendale, Arizona.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Clinical Sciences, College of Veterinary Medicine, Auburn University, Auburn, Alabama.'}]",Veterinary surgery : VS,['10.1111/vsu.13439']
80,32229250,An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations.,"OBJECTIVES


This study investigated trial consultations to identify whether and to what extent discussions of retention are present.
STUDY DESIGN AND SETTING


This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT. Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs).
RESULTS


Forty-four participants were included in this study: potential trial participants (n = 37); TSs (n = 4); and RNs (n = 3). Analysis revealed no discussion of retention across 79% of consultations. Of the remaining 21% where discussions of retention were present, only 3% (maximum) of the conversation related to retention. There was some evidence of good practice, but on the whole the discussions contained inaccuracies about timing and delivery of questionnaires and the right to withdraw often highlighted without providing trial consequences.
CONCLUSION


This study is the first to explore trial consultations for discussions of retention. It suggests that there may be room for improvement within current practice. Further research is required to determine the generalizability of the findings reported to other clinical trials.",2020,Analysis revealed no discussion of retention across 79% of consultations.,"['Study participants included potential trial participants, trial surgeons (TSs), and research nurses (RNs', 'purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-based surgical RCT', 'Forty-four participants were included in this study: potential trial participants (n\xa0=\xa037); TSs (n\xa0=\xa04); and RNs (n\xa0=\xa03']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4319568', 'cui_str': '44'}]",[],[],44.0,0.176627,Analysis revealed no discussion of retention across 79% of consultations.,"[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Tunji-Ajayi', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Eilidh M', 'Initials': 'EM', 'LastName': 'Duncan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK. Electronic address: k.gillies@abdn.ac.uk.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.03.011']
81,32229324,Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial.,"Drugs targeting N-methyl-d-aspartate (NMDA) receptors and the ability to learn new associations have been proposed as adjunct treatments to boost the success of exposure therapy for anxiety disorders. However, the effects of the NMDA partial agonist d-cycloserine on psychological treatment have been mixed. We investigated potential neurocognitive mechanisms underlying the clinical effects of d-cycloserine-augmented exposure, to inform the optimal combination of this and similar agents with psychological treatment. Panic disorder patients were randomised to single-dose d-cycloserine (250 mg; N = 17) or matching placebo (N = 16) 2hrs before one session of exposure therapy. Neurocognitive markers were assessed one day after treatment, including reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome). Clinical symptom severity was measured the day before and after treatment, and at 1- and 6-months follow-up (secondary outcome). d-cycloserine was associated with greater clinical recovery at 1-month follow-up than placebo (d-cyloserine 71% vs placebo 25%), with the placebo group matching the clinical gains of the d-cycloserine group during 6-months follow-up (d-cycloserine 71% vs placebo 44%). One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group. Lower amygdala magnitude predicted greater clinical improvement during follow-up across groups. While this experimental study is of a preliminary nature due to the limited sample size, these findings highlight a neurocognitive potential mechanism by which d-cycloserine may exert its augmentative effects on psychological treatment and bring forward a marker that may help understand and facilitate development of combination treatments for anxiety. (d-cycloserine Augmented CBT for Panic Disorder; clinicaltrials.gov; NCT01680107).",2020,"One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group.","['Panic disorder patients', 'anxiety']","['placebo', 'matching placebo', 'cycloserine augmented single-session exposure therapy', 'NMDA partial agonist d-cycloserine', 'single-dose d-cycloserine']","['threat bias for fearful faces and amygdala threat response', 'Clinical symptom severity', 'clinical recovery', 'reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome', 'Neurocognitive markers', 'Neurocognitive processes']","[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.358042,"One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. Electronic address: andrea.reinecke@psych.ox.ac.uk.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103607']
82,32393551,Alterations in plasma triglycerides and ceramides: links with cardiac function in humans with type 2 diabetes.,"Cardiac dysfunction in T2D is associated with excessive FA uptake, oxidation, and generation of toxic lipid species by the heart. It is not known whether decreasing lipid delivery to the heart can effect improvement in cardiac function in humans with T2D. Thus, our objective was to test the hypothesis that lowering lipid delivery to the heart would result in evidence of decreased ""lipotoxicity,"" improved cardiac function, and salutary effects on plasma biomarkers of cardiovascular risk. Thus, we performed a double-blind randomized placebo-controlled parallel design study of the effects of 12 weeks of fenofibrate-induced lipid lowering on cardiac function, inflammation, and oxidation biomarkers, and on the ratio of two plasma ceramides, Cer d18:1 (4E) (1OH, 3OH)/24:0 and Cer d18:1 (4E) (1OH, 3OH)/16:0 (i.e., ""C24:0/C16:0""), which is associated with decreased risk of cardiac dysfunction and heart failure. Fenofibrate lowered plasma TG and cholesterol but did not improve heart systolic or diastolic function. Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation. Overall, plasma TG lowering correlated with improvement of cardiac relaxation (diastolic function) as measured by tissue Doppler-derived parameter e'. Moreover, lowering the plasma C24:0/C16:0 ceramide ratio was correlated with worse diastolic function. These findings indicate that fenofibrate treatment per se is not sufficient to effect changes in cardiac function; however, decreases in plasma TG may be linked to improved diastolic function. In contrast, decreases in plasma C24:0/C16:0 are linked with worsening cardiac function.",2020,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"['humans with type 2 diabetes', 'humans with T2D', 'type 2 diabetes (T2D']","['Fenofibrate', 'fenofibrate', 'fenofibrate-induced lipid-lowering', 'placebo']","['plasma C24:0/C16:0', 'risk of cardiac dysfunction and heart failure', 'cardiac function, inflammation and oxidation biomarkers, and on the ratio of two plasma ceramides - Cer d18:1 (4E) (1OH, 3OH)/24:0 \xa0and Cer d18:1 (4E) ', 'cardiac relaxation (diastolic function', 'plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers', 'plasma TG and cholesterol', 'Cardiac dysfunction', 'heart systolic or diastolic function', 'plasma C24:0/C16:0 ceramide ratio', 'diastolic function']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0237504', 'cui_str': 'CER'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.0435397,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110 lpeterso@wustl.edu.'}, {'ForeName': 'Xuntian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Marsha S', 'Initials': 'MS', 'LastName': 'Farmer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ory', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Jean E', 'Initials': 'JE', 'LastName': 'Schaffer', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA 02215.'}]",Journal of lipid research,['10.1194/jlr.RA120000669']
83,32396017,"Effects of blackcurrant extract on arterial functions in older adults: A randomized, double-blind, placebo-controlled, crossover trial.","PURPOSE


Blackcurrant extract mainly contains anthocyanins. Several reports suggest that anthocyanins have beneficial effect for cardiovascular functions. The aim of this study was to examine the effect of 7-day intake of New Zealand blackcurrant (NZBC) extract on arterial functions, e.g. arterial stiffness, and serum lipids.
METHODS


A randomized, double-blind, placebo-controlled, crossover design study with a washout period of 28 days was conducted. Fourteen older adults participated in this study (age 73.3 ± 1.7 years). Participants took either a 7-day course of placebo or two capsules of NZBC extract (each 300 mg capsule contains 35% blackcurrant extract). Participants took one of the two trials first and then took the other after a washout period. Carotid-femoral pulse-wave velocity, an index of central arterial stiffness, and central blood pressure were measured at baseline and again at the end of the 7-day study period.
RESULTS


Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake. In addition, carotid-femoral pulse-wave velocity ( P  = .04) and central blood pressure ( P  = .001) in the NZBC intake trial decreased significantly more than in the placebo intake trial. No effects were observed on serum lipids.
CONCLUSION


These results suggest that short-term NZBC intake reduces central arterial stiffness and central blood pressure in older adults. Therefore, anthocyanin-rich blackcurrants might be beneficial for maintaining or improving cardiovascular health as an alternative to pharmaceutical medications.
ABBREVIATIONS


Aix: augmentation index; BP: blood pressure; cfPWV: carotid-femoral pulse-wave velocity;  CVD: cardiovascular diseases; DBP: diastolic blood pressure;  faPWV: femoral-ankle pulse-wave velocity; FG: fasting glucose; HDL: high-density lipoprotein cholesterol; LDL: low-density lipoprotein cholesterol; MBP: mean blood pressure; NZBC: New Zealand blackcurrant; PP: pulse pressure; SBP: systolic blood pressure; TG: triglycerides.",2020,"Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake.","['older adults', 'Fourteen older adults participated in this study (age 73.3\xa0±\xa01.7\xa0years', 'Abbreviations ']","['anthocyanins', 'Blackcurrant extract mainly contains anthocyanins', 'blackcurrant extract', 'New Zealand blackcurrant (NZBC) extract', 'placebo or two capsules of NZBC extract', 'NZBC intake', 'placebo']","['carotid-femoral pulse-wave velocity', 'Carotid-femoral pulse-wave velocity, an index of central arterial stiffness, and central blood pressure', 'central arterial stiffness and central blood pressure', 'arterial functions', 'serum lipids', 'arterial functions, e.g. arterial stiffness, and serum lipids', 'central blood pressure']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",14.0,0.385975,"Compared to baseline, carotid-femoral pulse-wave velocity ( P  = .03) and central blood pressure ( P  = .02) decreased significantly after the 7-day study period with NZBC intake.","[{'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University , Tokyo, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University , Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Fundamental Education, Teikyo University of Science , Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakazato', 'Affiliation': 'Department of Exercise Physiology, Nippon Sport Science University , Tokyo, Japan.'}, {'ForeName': 'Mark Elisabeth Theodorus', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester , Chichester, UK.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1764015']
84,32396038,Hypertrophy of Lumbopelvic Muscles in Inactive Women: A 36-Week Pilates Study.,"BACKGROUND


The use of Pilates in various fields of sport sciences and rehabilitation is increasing; however, little is known about the muscle adaptations induced by this training method.
HYPOTHESIS


A standardized Pilates training program for beginners (9 months; 2 sessions of 55 minutes per week) will increase the muscle volume and reduce potential side-to-side asymmetries of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles (gluteus maximus, medius, and minimus).
STUDY DESIGN


Controlled laboratory study.
LEVEL OF EVIDENCE


Level 3.
METHOD


A total of 12 inactive, healthy women (35.7 ± 5.4 years) without previous experience in Pilates were randomly selected to participate in a supervised Pilates program (36 weeks, twice weekly). Muscle volume (cm 3 ) was determined using magnetic resonance imaging at the beginning and end of the intervention program. Side-to-side asymmetry was calculated as [(left - right volume) × 100/right volume].
RESULTS


Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints. Before and after Pilates, side-to-side asymmetry was less than 6% and nonsignificant in all muscles analyzed.
CONCLUSION


Modern Pilates performed twice weekly for 9 months did not elicit substantial changes in the volume and degree of asymmetry of the selected lumbopelvic muscles in inactive women.
CLINICAL RELEVANCE


The benefits of Pilates in rehabilitation or training are likely elicited by neuromuscular rather than morphological adaptations. Pilates has no significant impact on muscle volume and does not alter side-to-side ratios in muscle volume (degree of asymmetry) of the lumbopelvic muscles.",2020,"Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints.","['Inactive Women', 'A total of 12 inactive, healthy women (35.7 ± 5.4 years) without previous experience in Pilates']",['supervised Pilates program'],"['volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles', 'muscle volume and reduce potential side-to-side asymmetries of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles (gluteus maximus, medius, and minimus']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0224417', 'cui_str': 'Structure of iliopsoas muscle'}, {'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}]",,0.0151886,"Small, nonsignificant ( P  > 0.05) differences in the volume of the quadratus lumborum, iliopsoas, piriformis, and gluteus muscles were observed between pre- and post-Pilates program timepoints.","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dorado', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'López-Gordillo', 'Affiliation': 'Department of Physical Education Department, University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Serrano-Sánchez', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'José A L', 'Initials': 'JAL', 'LastName': 'Calbet', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Sanchis-Moysi', 'Affiliation': 'Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Canary Islands, Spain.'}]",Sports health,['10.1177/1941738120918381']
85,32399799,Effect of FAmily CEntered (FACE®) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial.,"Trial tested effect of advance care planning on family/surrogates' understanding of patients' end-of-life treatment preferences longitudinally. A multisite, assessor-blinded, intent-to-treat, parallel-group, randomized controlled clinical trial in five hospital-based HIV clinics enrolled 449 participants aged 22 to 77 years during October 2013-March 2017. Patients living with HIV/family dyads were randomized at 2:1 ratio to 2 weekly ~ 60-min sessions either ACP (n = 155 dyads)-(1) ACP facilitated conversation, (2) Advance directive completion; or Control (n = 68 dyads)-(1) Developmental/relationship history, (2) Nutrition/exercise tips. ACP families/surrogates were more likely to accurately report patients' treatment preferences at Time 1 (T 1 ) and 12 months post-intervention (T 2 ) compared to controls, experiencing high congruence longitudinally (high→high transition), [63·6% vs 37·7% (difference = 25·9%, 95% CI: 11·3%, 40·4%, χ 2  = 11·52, p = 0·01)], even as patients' preferences changed over time. ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3). Conversations matter.",2020,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","['five hospital-based HIV clinics enrolled 449 participants aged 22 to 77\xa0years during October 2013-March 2017', 'Patients living with HIV/family dyads', 'Longitudinal Congruence in End-of-Life Treatment Preferences']","['Control (n\u2009=\u200968 dyads)-(1', 'FAmily CEntered (FACE®', 'ACP (n\u2009=\u2009155 dyads)-(1', 'advance care planning', 'Advance Care Planning']",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001369', 'cui_str': 'Acyl Carrier Protein'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",[],449.0,0.0733186,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA. mlyon@childrensnational.org.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Squires', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Scott', 'Affiliation': 'MedStar: Health Research Institute and Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Benator', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Briggs', 'Affiliation': 'Respecting Choices, Coalition to Transform Advance Care Innovations, Washington, DC, USA.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Greenberg', 'Affiliation': ""Medical Education, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Yao Iris', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics & Study Methodology, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02909-y']
86,32216456,"Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study.","BACKGROUND


This study reports the long-term safety and efficacy of erenumab in chronic migraine patients.
METHODS


This was a 52-week open-label extension study of a 12-week double-blind treatment phase study. During the double-blind treatment phase, patients received placebo or once-monthly erenumab 70 mg or 140 mg. During the open-label treatment phase, the initial monthly dose was erenumab 70 mg. Following protocol amendment, patients continued to receive erenumab 70 mg if they had already completed their Week 28 visit, otherwise, patients switched from 70 mg to 140 mg; if enrolled after the amendment, patients received 140 mg monthly throughout.
RESULTS


In all, 451/609 (74.1%) enrolled patients completed the study. The exposure-adjusted patient incidence rate for any adverse event was 126.3/100 patient-years for the overall erenumab group. Overall, the adverse event profile was similar to that observed in the double-blind treatment phase. Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen. Efficacy was sustained throughout the 52 weeks. Clinically significant reductions from double-blind treatment phase baseline (about half) were observed for monthly migraine days and migraine-specific medication days. Achievement of ≥50%, ≥75% and 100% reductions from the double-blind treatment phase baseline in monthly migraine days at Week 52 were reported by 59.0%, 33.2% and 8.9% of patients, respectively, for the combined dose group. A numerically greater benefit was observed with 140 mg compared with 70 mg at Weeks 40 and 52.
CONCLUSIONS


Sustained efficacy of long-term erenumab treatment in patients with chronic migraine is demonstrated, with safety results consistent with the known safety profile of erenumab and adverse event rates comparable to placebo adverse event rates in the double-blind treatment phase.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov (NCT02174861).",2020,"Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.","['chronic migraine patients', 'patients with chronic migraine']","['placebo or once-monthly erenumab 70\u2009mg or 140\u2009mg', 'erenumab']","['adverse event profile', 'Adverse event incidence rates', 'Efficacy']","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.411908,"Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.","[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jan Lewis', 'Initials': 'JL', 'LastName': 'Brandes', 'Affiliation': 'Nashville Neuroscience Group and Vanderbilt University Department of Neurology, Nashville, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Doležil', 'Affiliation': 'Prague Headache Center DADO MEDICAL sro, Prague, Czech Republic.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Winner', 'Affiliation': 'Premiere Research Institute, Nova Southeastern University, West Palm Beach, FL, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Global Biostatistical Science, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Global Development, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Global Development, Amgen Inc, Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420912726']
87,32259695,"Initial evidence for pharmacological modulation of observational threat learning by the GABAergic, but not the noradrenergic system in humans.","Threat responses are often shaped by social information, such as observation of aversive outcomes for others. Yet, the neurochemistry regulating observational learning of threats is largely unknown. Here, we examined the impact of the GABAergic and noradrenergic system, which are central in regulating threat learning from first-hand experiences, on observational threat learning in humans. To this end, 61 participants received either 1 mg Lorazepam (enhancing GABAergic signalling N = 18), 20 mg Yohimbine (enhancing Noradrenergic transmission, N = 16), Placebo (double blind and randomized control for Lorazepam and Yohimbine, N = 12) or no treatment (N = 15) prior to observational threat conditioning. Participants acquired conditioned threat responses by observation of another individual who is presented with a conditioned stimulus (CS) and an aversive unconditioned stimulus (US). Participants' threat responses were tested by direct exposure to the CSs immediately after learning, as well as two days later (drug free). Our results indicate decreased fear ratings to socially acquired CSs by enhanced GABAergic transmission as compared to the control group (placebo and no treatment) during the immediate test. We could not provide evidence for noradrenergic modulation of socially acquired threat responses. Further, we found no differences in psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses. Our results provide initial evidence for an impact of the GABAergic system on social acquisition of threats.",2020,"Further, we found no differences in psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses.","['61 participants received either', 'humans']","['1\xa0mg Lorazepam', 'Yohimbine (enhancing Noradrenergic transmission, N\xa0=\xa016), Placebo (double blind and randomized control for Lorazepam and Yohimbine, N\xa0=\xa012) or no treatment (N\xa0=\xa015) prior to observational threat conditioning']","['psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses', 'fear ratings']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0495426,"Further, we found no differences in psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Esser', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fuss', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Haaker', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany. Electronic address: j.haaker@uke.de.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103605']
88,32396668,Effectiveness of a short web-based film targeting parental oral health knowledge in a well-child care setting.,"Young children rely on their parents with respect to oral health routines. However, parental knowledge on this topic is often insufficient. Well-child care may be an excellent route to reach parents because almost all of them attend. To evaluate the effectiveness of an 8.5 min web-based film about oral health, provided by well-child care, a non-blinded quasi-experimental study was performed. Parents attending well-child care clinics in the Netherlands were assigned to an intervention (n = 88) or control group (n = 41). The control group received care as usual. We measured parental knowledge of oral health with a questionnaire (range of scores 1-12) before and directly after the intervention, and 6 months later, and assessed differences between the intervention and the control group. Parental oral health knowledge improved after watching the film: the intervention group's mean score of 11.1 (SD 1.3) was greater than the mean score of 7.1 (SD 2.0) of the control group (Cohen's d = 2.64). Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25). A web-based educational film delivered in a well-child care setting can be an effective way to address oral health and to improve parental knowledge.",2020,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).",['Parents attending well-child care clinics in the Netherlands'],['short web-based film targeting parental oral health knowledge'],"['parental knowledge of oral health', 'Parental oral health knowledge']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0312641,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).","[{'ForeName': 'Deborah Ashley', 'Initials': 'DA', 'LastName': 'Verlinden', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'Schuller', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sijmen A', 'Initials': 'SA', 'LastName': 'Reijneveld', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research TNO, Leiden, the Netherlands.'}]",European journal of oral sciences,['10.1111/eos.12700']
89,32336038,"Safety and Efficacy of Lenabasum in a Phase II, Randomized, Placebo-Controlled Trial in Adults With Systemic Sclerosis.","OBJECTIVE


To assess the safety and efficacy of lenabasum in diffuse cutaneous systemic sclerosis (dcSSc).
METHODS


A randomized, double-blind, placebo-controlled, phase II study was conducted at 9 SSc clinics in the US. Adults with dcSSc of ≤6 years' duration who were receiving stable standard-of-care treatment were randomized to receive lenabasum (n = 27) or placebo (n = 15). Lenabasum doses were 5 mg once daily, 20 mg once daily, or 20 mg twice daily for 4 weeks, followed by 20 mg twice daily for 8 weeks. Safety and efficacy were assessed at weeks 4, 8, 12, and 16.
RESULTS


Adverse events (AEs) occurred in 63% of the lenabasum group and 60% of the placebo group, with no serious AEs related to lenabasum. Compared to placebo, lenabasum treatment was associated with greater improvement in the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcome measures that assessed overall disease, skin involvement, and patient-reported function. The median CRISS score increased in the lenabasum group during the study, reaching 0.33, versus 0.00 in the placebo group, at week 16 (P = 0.07 by 2-sided mixed-effects model repeated-measures analysis). Gene expression in inflammation and fibrosis pathways was reduced, and inflammation and fibrosis were improved on histologic evaluation of skin biopsy specimens, in the lenabasum group compared to the placebo group (all P ≤ 0.05).
CONCLUSION


Despite a short trial duration in a small number of patients in this phase II study in dcSSc, our findings indicate that lenabasum improves efficacy outcomes and underlying disease pathology with a favorable safety profile.",2020,"Lenabasum treatment compared to placebo was associated with greater improvement in American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcomes that assessed overall disease, skin involvement, and patient-reported function.","['Adults with dcSSc ≤ 6 years duration on stable standard-of-care treatment received lenabasum (N = 27) or', 'adults with systemic sclerosis', 'diffuse cutaneous systemic sclerosis (dcSSc', 'nine SSc clinics in the USA']","['placebo', 'lenabasum']","['American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score', 'Safety and efficacy', 'Gene expression in inflammation and fibrosis pathways', 'Adverse events', 'CRISS score', 'Safety and efficacy assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.474232,"Lenabasum treatment compared to placebo was associated with greater improvement in American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score and other efficacy outcomes that assessed overall disease, skin involvement, and patient-reported function.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hummers', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lorinda', 'Initials': 'L', 'LastName': 'Chung', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, and Palo Alto VA Health Care System, Palo Alto, California.'}, {'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Frech', 'Affiliation': 'University of Utah, and Salt Lake City VA Health Care System.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Domsic', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hsu', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Arthritis Association of Southern California, Los Angeles, California.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'University of Texas Health Science Center at Houston.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simms', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lafyatis', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Martyanov', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Tammara', 'Initials': 'T', 'LastName': 'Wood', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Whitfield', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Constantine', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Dgetluck', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'White', 'Affiliation': 'Corbus Pharmaceuticals, Norwood, Massachusetts.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41294']
90,32278195,Cardiorespiratory responses to fine particles during ambient PM 2.5  pollution waves: Findings from a randomized crossover trial in young healthy adults.,"BACKGROUND


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


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


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


PPWs could affect cardiopulmonary health through systematic oxidative stress, platelet activation and respiratory inflammation in healthy adults, and short-term indoor air purification could alleviate the adverse cardiopulmonary effects.",2020,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","['healthy adults', 'young healthy adults', '29 healthy young adults']",[],"['blood pressure (BP), pulmonary function, fractional exhaled nitric oxide (FeNO) and circulating biomarkers which reflect platelet activation, blood coagulation and systematic oxidative stress', 'levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α', 'FeNO and soluble P-selectin (sP-selectin', 'cardiopulmonary mortality and morbidity', 'health biomarkers', 'Cardiorespiratory responses', 'sP-selectin', 'pulmonary function']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",29.0,0.0335382,"Significant associations between time-weighted personal PM 2.5  exposure and increased levels of health biomarkers including FeNO, sP-selectin, oxidized low-density lipoprotein (ox-LDL) and 8-isoprostane (8-isoPGF2α) were found.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Minghao', 'Initials': 'M', 'LastName': 'Kou', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Zemin', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: jing_huang@bjmu.edu.cn.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, Peking University School of Public Health, Beijing, China. Electronic address: guoxb@bjmu.edu.cn.'}]",Environment international,['10.1016/j.envint.2020.105590']
91,32213737,Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent　- A Randomized Comparison Through 5 Years in Japan.,"BACKGROUND


Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction [MI], and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.
CONCLUSIONS


Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).",2020,There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years.,"['patients in Japan with de novo coronary artery lesions', '400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm']","['Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent\u3000', 'XIENCE metallic DES', 'Absorb BVS']","['rates of device-oriented events', 'DMR (death, myocardial infarction [MI], and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI', 'death, MI, coronary revascularization, and scaffold/stent thrombosis', 'scaffold/stent thrombosis', 'Absorb BVS', 'TVF, MACE, and all MI rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",400.0,0.0925617,There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Department of Cardiology, Mitsui Memorial Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hamazaki', 'Affiliation': 'Division of Cardiology, Ootakanomori Hospital.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiovascular Medicine, The University of Tokyo Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University Hospital.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shiga University of Medical Science.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kusano', 'Affiliation': 'Abbott Vascular.'}, {'ForeName': 'Divine', 'Initials': 'D', 'LastName': 'Ediebah', 'Affiliation': 'Abbott Vascular.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine/Graduate School of Medicine, Kyoto University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-1184']
92,32247219,Choosing endotracheal tube size in children: Which formula is best?,"OBJECTIVES


Various formulae have been suggested to calculate the appropriate sized endotracheal tube in children. The current study prospectively compares three commonly used formulae for selection of cuffed endotracheal tubes in children.
METHODS


Patients were randomized to one of three formulae (Duracher, Cole, or Khine) to determine the size of the cuffed endotracheal tube for endotracheal intubation. The fit of the tube was noted and intracuff pressure was measured using a manometer. The postoperative incidence of stridor, throat pain/soreness, and hoarseness was noted in the post-anesthesia care unit at 2, 4 and 24 h after the procedure.
RESULTS


The study cohort included 135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender. There was no difference in the intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure was greater than or equal to 20 or 30 cm H 2 O among the three groups. Six tube changes were required in the Cole group while no tube changes were required in the Duracher group (p < 0.05). The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
CONCLUSION


When using an endotracheal tube with a polyurethane cuff, the Duracher formula provided the best estimate for choosing the correct size.",2020,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
","['Patients', 'children', '135 patients less than or equal to 8 years, equally divided into three groups based on age, weight, and gender']","['cuffed endotracheal tubes', 'cuffed endotracheal tube for endotracheal intubation', 'three formulae (Duracher, Cole, or Khine']","['postoperative incidence of stridor, throat pain/soreness, and hoarseness', 'intracuff pressure, the volume required to seal the airway, or the number of times in which the intracuff pressure', 'intracuff pressure', 'postoperative incidence of adverse events (throat pain, hoarseness, and stridor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C3809781', 'cui_str': 'Cole disease'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0242429', 'cui_str': 'Pain in throat'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",135.0,0.0226457,"The postoperative incidence of adverse events (throat pain, hoarseness, and stridor) at 0-2 h, 2-4 h, and 24 h was higher in the Cole group when compared to the Duracher group.
","[{'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Manimalethu', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Krishna', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Shabana Z', 'Initials': 'SZ', 'LastName': 'Shafy', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: shabana.shafy@nationwidechildrens.org.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hakim', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA; Department of Anesthesiology & Pain Medicine, The Ohio State University College of Medicine, Columbus, OH, USA.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110016']
93,32220745,The effect of green walking on heart rate variability: A pilot crossover study.,"We investigated the effects of regular walking in green and suburban environments on heart rate variability (HRV) and blood pressure (BP) in middle-aged adults. Twenty-three adults participated in a non-randomized crossover experiment comprised of once-weekly 50-min moderate-intensity walking sessions. Separated by a two-week washout period, participants walked for three weeks in each of two treatment conditions (green and suburban) in a local arboretum and suburban sidewalks of Chaska, MN. Eleven participants completed green walking first and 12 suburban walking first. Walks were split into 15-min intra-walk phases, with phases representing each walk's beginning, middle, and final 15-min. Repeated measures linear mixed models evaluated (1) HRV phase differences between treatments and HRV change within treatments, and (2) pre- and post-walk BP differences between treatments and pre-to post-walk BP changes. Intra-walk phase analyses revealed higher HRV during green walking vs. suburban walking during phase 2 (p < 0.0001) and phase 3 (p = 0.02). Less HRV reduction was seen between intra-walk phases 1 and 2 during green vs. suburban walking (p = 0.02). Pre-to post-walk changes revealed decreased mean systolic BP for both green (p = 0.0002) and suburban (p = 0.003) walking conditions, but not for diastolic BP. Post-walk BP results were similar after both green walking and suburban walking. In summary, walking sessions in a green environment elicited greater beneficial HRV responses compared to a suburban environment. Additionally, walking in either environment, green or suburban, promoted reductions in systolic BP.",2020,"Pre-to post-walk changes revealed decreased mean systolic BP for both green (p = 0.0002) and suburban (p = 0.003) walking conditions, but not for diastolic BP.","['middle-aged adults', 'Eleven participants completed green walking first and 12 suburban walking first', 'Twenty-three adults participated']","['once-weekly 50-min moderate-intensity walking sessions', 'green walking', 'regular walking in green and suburban environments']","['mean systolic BP', 'systolic BP', 'beneficial HRV responses', 'HRV change within treatments, and (2) pre- and post-walk BP differences', 'HRV reduction', 'heart rate variability', 'heart rate variability (HRV) and blood pressure (BP', 'diastolic BP']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",23.0,0.0282478,"Pre-to post-walk changes revealed decreased mean systolic BP for both green (p = 0.0002) and suburban (p = 0.003) walking conditions, but not for diastolic BP.","[{'ForeName': 'Junia N', 'Initials': 'JN', 'LastName': 'de Brito', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: nogue013@umn.edu.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Pope', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: popex157@umn.edu.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Mitchell', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: mitc0186@umn.edu.'}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Schneider', 'Affiliation': 'Department of Forest Resources, University of Minnesota, 1530 Cleveland Ave North, Suite 301b, St. Paul, MN, 55108, USA. Electronic address: ingridss@umn.edu.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Larson', 'Affiliation': 'Minnesota Landscape Arboretum, Bakken Center for Spirituality & Healing, University of Minnesota, 3675 Arboretum Drive, Chaska, MN, 55318, USA. Electronic address: larso095@umn.edu.'}, {'ForeName': 'Teresa H', 'Initials': 'TH', 'LastName': 'Horton', 'Affiliation': 'Department of Anthropology, Northwestern University, 1819 Hinman Avenue, Evanston, IL, 60208, USA. Electronic address: thorton@northwestern.edu.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pereira', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, 1300 S 2nd St, Suite 300, Minneapolis, MN, 55455, USA. Electronic address: perei004@umn.edu.'}]",Environmental research,['10.1016/j.envres.2020.109408']
94,31778656,"Digital single-operator peroral cholangioscopy-guided biopsy sampling versus ERCP-guided brushing for indeterminate biliary strictures: a prospective, randomized, multicenter trial (with video).","BACKGROUND AND AIMS


Accurately diagnosing indeterminate biliary strictures is challenging but important for patient prognostication and further management. Biopsy sampling under direct cholangioscopic vision might be superior to standard ERCP techniques such as brushing or biopsy sampling. Our aim was to investigate whether digital single-operator cholangioscopy (DSOC) compared with standard ERCP workup improves the diagnostic yield in patients with indeterminate biliary strictures.
METHODS


Patients with an indeterminate biliary stricture on the basis of MRCP were randomized to standard ERCP visualization with tissue brushing (control arm [CA]) or DSOC visualization and DSOC-guided biopsy sampling (study arm [SA]). This was a prospective, international, multicenter trial with a procedure-blinded pathologist.
RESULTS


The first sample sensitivity of DSOC-guided biopsy samples was significantly higher than ERCP-guided brushing (SA 68.2% vs CA 21.4%, P < .01). The sensitivity of visualization (SA 95.5% vs CA 66.7%, P = .02) and overall accuracy (SA 87.1% vs CA 65.5%, P = .05) were significantly higher in the SA compared with the CA, whereas specificity, positive predictive value, and negative predictive value showed no significant difference. Adverse events were equally low in both arms.
CONCLUSIONS


DSOC-guided biopsy sampling was shown to be safe and effective with a higher sensitivity compared with standard ERCP techniques in the visual and histopathologic diagnosis of indeterminate biliary strictures. (Clinical trial registration number: NCT03140007.).",2020,"The sensitivity of visualization (SA 95.5% vs CA 66.7%; P=0.02) and overall accuracy (SA 87.1% vs CA 65.5%, P=0.05) were significantly higher in the SA compared with the CA whereas specificity, positive predictive value, and negative predictive value showed no significant difference.","['indeterminate biliary strictures', 'patients with indeterminate biliary strictures', 'Patients with an indeterminate biliary stricture on the basis of MRCP']","['standard ERCP visualization with tissue brushing (Control Arm [CA]) or DSOC visualization and DSOC-guided biopsy (Study Arm [SA', 'Digital single-operator peroral cholangioscopy-guided biopsy versus ERCP-guided brushing', 'digital single-operator cholangioscopy (DSOC']","['Adverse events', 'DSOC-guided biopsies', 'overall accuracy', 'sensitivity of visualization']","[{'cui': 'C0205258', 'cui_str': 'Indeterminate (qualifier value)'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0994163', 'cui_str': 'Cholangiopancreatography, Magnetic Resonance'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0940834', 'cui_str': 'Cholangioscopy (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.0609634,"The sensitivity of visualization (SA 95.5% vs CA 66.7%; P=0.02) and overall accuracy (SA 87.1% vs CA 65.5%, P=0.05) were significantly higher in the SA compared with the CA whereas specificity, positive predictive value, and negative predictive value showed no significant difference.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerges', 'Affiliation': 'Department of General Internal Medicine and Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Beyna', 'Affiliation': 'Department of General Internal Medicine and Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Raymond S Y', 'Initials': 'RSY', 'LastName': 'Tang', 'Affiliation': 'Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Farzan', 'Initials': 'F', 'LastName': 'Bahin', 'Affiliation': 'Department of General Internal Medicine and Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'James Y W', 'Initials': 'JYW', 'LastName': 'Lau', 'Affiliation': 'Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'van Geenen', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Neuhaus', 'Affiliation': 'Department of General Internal Medicine and Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Duvvur', 'Initials': 'D', 'LastName': 'Nageshwar Reddy', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; Asian Institute of Gastroenterology Hospitals, Hyderabad, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Ramchandani', 'Affiliation': 'Asian Institute of Gastroenterology Hospitals, Hyderabad, India.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.025']
95,32146231,The efficacy and safety of multiple-dose intravenous tranexamic acid in reducing perioperative blood loss in patients with thoracolumbar burst fracture.,"OBJECTIVE


To evaluate the efficacy and safety of tranexamic acid (TXA) for single-segment thoracolumbar burst fracture without neurologic injury underwent pedicle screw fixation via Wiltse approach.
PATIENTS AND METHODS


We identified 264 patients with single-segment thoracolumbar burst fracture without neurologic injury underwent pedicle screw fixation via Wiltse approach (January 2016-June 2019) at a single center. The cohort was separated into three groups. Group A received 20 mg/kg TXA at 5 min before skin incision and 16 h after first dose; Group B received 20 mg/kg TXA at 5 min before skin incision; Group C received NS at each same time point. The outcomes were evaluated by hidden blood loss (HBL), total blood loss (TBL), intraoperative blood loss (IBL), transfusion rate, maximum hemoglobin (Hb) drop, prethrombotic state molecular markers, liver and renal function, coagulation function, inflammatory factor and adverse events.
RESULTS


The HBL, TBL and maximum Hb drop were significantly lower in Group A than those of Group B and Group C, while the difference between Group B and Group C was statistically significant. The IBL was significantly lower in Group A and Group B than that of Group C. However, there was no significantly difference among the three groups in live and renal function, coagulation function, prethrombotic state molecular markers, transfusion rate and complications during the perioperative period. There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
CONCLUSIONS


Intravenous TXA used in the treatment of thoracolumbar burst fracture underwent pedicle screw fixation via Wiltse approach is effective and safe in decreasing perioperative blood loss. The two-dose TXA regimen can further reduce blood loss and alleviate post-operative inflammation response, without affecting prethrombotic state molecular marks and without increasing the risk of complications.",2020,"There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
","['patients with thoracolumbar burst fracture', '264 patients with single-segment thoracolumbar burst fracture without neurologic injury underwent']","['tranexamic acid', 'pedicle screw fixation', 'pedicle screw fixation via Wiltse approach', '20 mg/kg TXA', 'TXA', 'tranexamic acid (TXA']","['hidden blood loss (HBL), total blood loss (TBL), intraoperative blood loss (IBL), transfusion rate, maximum hemoglobin (Hb) drop, prethrombotic state molecular markers, liver and renal function, coagulation function, inflammatory factor and adverse events', 'level of interleukin-6 (IL-6', 'blood loss and alleviate post-operative inflammation response', 'HBL, TBL and maximum Hb drop', 'live and renal function, coagulation function, prethrombotic state molecular markers, transfusion rate and complications', 'perioperative blood loss', 'level of C-reactive protein (CRP', 'IBL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0345035,"There was significantly lower level of interleukin-6 (IL-6) in Group A than Group C at the day after surgery, and lower level of C-reactive protein (CRP) at the third day after surgery.
","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Dalian Medical University, Dalian, 116000, China; Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Nan', 'Affiliation': ""Department of Orthopedics, Dalian Medical University, Dalian, 116000, China; Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Orthopaedic Implants, Shanghai, 200011, China.""}, {'ForeName': 'Shengfei', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, Clinical Medical College of Yangzhou University, Subei People's Hospital of Jiangsu Province, Yangzhou, 225001, China. Electronic address: zhangliang6320@sina.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105766']
96,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


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


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


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


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
97,32325176,Effect of preparation design on the fracture behavior of ceramic occlusal veneers in maxillary premolars.,"OBJECTIVES


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


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


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


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


The occlusal veneers with different preparation designs, including type O, OF, POF and POFP veneers, show higher fracture resistances than traditional full coverage crowns that considerably exceed the normal biting forces. Therefore, these represent conservative alternatives to crown restorations and present a viable treatment for restoring severely worn teeth.",2020,Both type O and OF veneers exhibited higher fracture strength than full crown (P <  0.05).,"['Forty intact maxillary premolars', 'maxillary premolars']",[],"['fracture behavior of ceramic occlusal veneers', 'failure mode', 'maximum principal stress for type O, OF, POF, POFP veneers, and full crown', 'fracture strengths', 'fracture strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]",[],"[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",40.0,0.0209738,Both type O and OF veneers exhibited higher fracture strength than full crown (P <  0.05).,"[{'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: huangxq36@mail2.sysu.edu.cn.""}, {'ForeName': 'Leiyan', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: zouly5@mail2.sysu.edu.cn.""}, {'ForeName': 'Run', 'Initials': 'R', 'LastName': 'Yao', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: shuyiwu@21cn.com.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Hospital of Stomatology, Guanghua School of Stomatology, Guangdong Provincial Key Laboratory of Stomatology, Sun Yat-sen University, Guangzhou, People's Republic of China. Electronic address: liy8@mail.sysu.edu.cn.""}]",Journal of dentistry,['10.1016/j.jdent.2020.103346']
98,32326815,Effectiveness of a Three-Stage Intervention in Reducing Caregiver Distress During Pediatric Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial.,"More than one fourth of primary caregivers report clinically significant distress during the hematopoietic stem cell transplantation (HSCT) process. Providing early support to primary caregivers could reduce caregiver distress and improve the quality of life. This study examined the effects of a three-stage caregiver support intervention designed to reduce caregiver distress and improve quality of life during pediatric HSCT hospitalization. A two-group comparative study was conducted with repeated measures. Participants were randomly assigned to an intervention group or a control group. The intervention group received the support intervention 5 days before the transplant, 14 days after transplant, and 1 week before hospital discharge. The control group received standard support provided in the hospital ward. Measures were obtained at all three time points from self-report questionnaires, which were related to anxiety, depression, perceived stress, and quality of life. Findings indicated that primary caregivers in the intervention group ( n  = 22) reported significantly lower levels of perceived stress and higher levels of quality of life than the control group ( n  = 23) at 14 days after transplant. In the intervention group, caregiver distress significantly decreased from pretransplant through 14 days after transplant, while over the same period caregiver quality of life significantly increased. The intervention effectively changed the trend of distress and quality of life for caregivers of children during the process of HSCT and hospitalization. The findings of this study suggest that it is important to provide early targeted interventions at critical junctures for caregivers at risk of adverse outcomes.",2020,This study examined the effects of a three-stage caregiver support intervention designed to reduce caregiver distress and improve quality of life during pediatric HSCT hospitalization.,['Pediatric Hematopoietic Stem Cell Transplantation'],"['Three-Stage Intervention', 'three-stage caregiver support intervention']","['Caregiver Distress', 'caregiver quality of life', 'distress and quality of life', 'anxiety, depression, perceived stress, and quality of life', 'levels of perceived stress and higher levels of quality of life', 'caregiver distress', 'quality of life']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0539787,This study examined the effects of a three-stage caregiver support intervention designed to reduce caregiver distress and improve quality of life during pediatric HSCT hospitalization.,"[{'ForeName': 'Ying-Mei', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': 'Chang Gung University of Science and Technology, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Wen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Pei-Yin', 'Initials': 'PY', 'LastName': 'Weng', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Tang-Her', 'Initials': 'TH', 'LastName': 'Jaing', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Shih-Hsiang', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Linkou Chang Gung Memorial Hospital, Taiwan.'}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220911358']
99,32233107,Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma.,"OBJECTIVE


To evaluate patient-reported outcome (PRO) data from the IMmotion150 study. The phase 2 IMmotion150 study showed improved progression-free survival with atezolizumab plus bevacizumab vs sunitinib in patients with programmed death-ligand 1 (PD-L1)+ tumours and suggested activity of atezolizumab monotherapy in previously untreated metastatic renal cell carcinoma (mRCC).
PATIENTS AND METHODS


Patients with previously untreated mRCC were randomised to atezolizumab 1200 mg intravenously (i.v.) every 3 weeks (n = 103), the atezolizumab regimen plus bevacizumab 15 mg/kg i.v. every 3 weeks (n = 101), or sunitinib 50 mg orally daily (4 weeks on, 2 weeks off; n = 101). The MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle. Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores were reported for all comers. The TTD was the first ≥2-point score increase over baseline. Absolute effect size ≥0.2 suggested a clinically important difference with checkpoint inhibitor therapy vs sunitinib.
RESULTS


Completion rates were >90% at baseline and ≥80% at most visits. Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference was observed with atezolizumab (both alone and in combination) vs sunitinib. Improved TTD (hazard ratio [HR], 95% confidence interval [CI]) was more pronounced with atezolizumab monotherapy: core symptoms, 0.39 (0.22-0.71); RCC symptoms, 0.22 (0.12-0.41); and symptom interference, 0.36 (0.22-0.58). Change from baseline by visit, evaluated by the MDASI, also showed a trend favouring atezolizumab monotherapy vs sunitinib. Small sample sizes may have limited the ability to draw definitive conclusions.
CONCLUSION


PROs suggested that atezolizumab alone or with bevacizumab maintained daily function compared with sunitinib. Notably, symptoms were least severe with atezolizumab alone vs sunitinib (IMmotion150; ClinicalTrials.gov Identifier: NCT01984242).",2020,MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle.,"['Previously Untreated Metastatic Renal Cell Carcinoma', 'patients with PD-L1+ tumours', 'Patients with previously untreated mRCC']","['bevacizumab', 'Bevacizumab Versus Sunitinib', 'Atezolizumab', 'atezolizumab alone versus sunitinib', 'atezolizumab monotherapy', 'atezolizumab plus bevacizumab', 'atezolizumab regimen plus bevacizumab', 'atezolizumab']","['progression-free survival', 'MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI', 'Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores', 'Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference', 'Completion rates']","[{'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.19299,MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle.,"[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Georges Pompidou Hospital, Paris Descartes University, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU H__pitaux de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suárez', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Elaine T', 'Initials': 'ET', 'LastName': 'Lam', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Caroleen', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault-Louis', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Royal Free Hospital, Queen Mary University of London, London, UK.'}]",BJU international,['10.1111/bju.15058']
100,31989690,Cost-effectiveness of basic vision rehabilitation (The basic VRS-effect study): study protocol for a randomised controlled trial.,"PURPOSE


To investigate the cost-effectiveness of a basic vision rehabilitation service (basic-VRS) in Portugal. We designed a parallel group, randomised controlled trial whose aim is to compare the effects and costs of 'usual low vision care' with a 'basic-VRS intervention' on self-reported visual ability and other psychosocial and health-related quality-of-life outcomes.
METHODS


The trial will recruit participants that meet the following inclusion criteria: (1) visual acuity between 0.4-1.0 logMAR in the better-seeing eye, (2) cause of vision loss is diabetic retinopathy or age-related macular degeneration, (3) 18 years or older and iv) live in the community (not in nursing homes or other type of institution). Participants will be randomised to one of the study arms consisting of immediate intervention and delayed intervention. The delayed intervention group will receive 'usual care' or no intervention in the first 12 weeks. Visual acuity, contrast sensitivity and retinal structure will be assessed during the study.
RESULTS


The primary outcome measure is visual ability, which will be evaluated with the Massof Activity Inventory, we expect that the intervention will raise the overall person measure or visual ability. Reading, health-related quality-of-life, anxiety and depression and social support will be also assessed. The analysis will be undertaken on an intention-to-treat basis. A cost-effectiveness analysis will be performed to provide information about the cost per unit of utility. To evaluate the cost-effectiveness of the intervention we will adopt the perspective of the healthcare system.
CONCLUSION


This study will provide additional evidence about the effects of basic-VRS on self-reported visual ability. Findings from this study should also contribute to better planning of low vision provision and, consequently, may contribute to reduce barriers to basic-VRS.",2020,"We designed a parallel group, randomised controlled trial whose aim is to compare the effects and costs of 'usual low vision care' with a 'basic-VRS intervention' on self-reported visual ability and other psychosocial and health-related quality-of-life outcomes.
","['participants that meet the following inclusion criteria: (1) visual acuity between 0.4-1.0 logMAR in the better-seeing eye, (2) cause of vision loss is diabetic retinopathy or age-related macular degeneration, (3) 18\xa0years or older and iv) live in the community (not in nursing homes or other type of institution']","['basic vision rehabilitation', 'basic vision rehabilitation service (basic-VRS', 'immediate intervention and delayed intervention', ""usual low vision care' with a 'basic-VRS intervention"", ""delayed intervention group will receive 'usual care' or no intervention""]","['Reading, health-related quality-of-life, anxiety and depression and social support', 'overall person measure or visual ability', 'Visual acuity, contrast sensitivity and retinal structure', 'cost-effectiveness', 'visual ability']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0042798', 'cui_str': 'Vision, Diminished'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037438'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.141058,"We designed a parallel group, randomised controlled trial whose aim is to compare the effects and costs of 'usual low vision care' with a 'basic-VRS intervention' on self-reported visual ability and other psychosocial and health-related quality-of-life outcomes.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hernández-Moreno', 'Affiliation': 'Department and Center of Physics-Optometry and Vision Science, University of Minho, Braga, Portugal.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Senra', 'Affiliation': 'School of Health and Social Care, University of Essex, Colchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine and Optometry, Linnaeus University, Kalmar, Sweden.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Moreno', 'Affiliation': 'Hospital Santa Maria Maior E.P.E, Barcelos, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Linhares', 'Affiliation': 'Department and Center of Physics-Optometry and Vision Science, University of Minho, Braga, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Santana', 'Affiliation': 'Public Health Research Centre, National School of Public Health, University NOVA, Lisbon, Portugal.'}, {'ForeName': 'Pedro Lima', 'Initials': 'PL', 'LastName': 'Ramos', 'Affiliation': 'Department and Center of Physics-Optometry and Vision Science, University of Minho, Braga, Portugal.'}, {'ForeName': 'Ana Patrícia', 'Initials': 'AP', 'LastName': 'Marques', 'Affiliation': 'Public Health Research Centre, National School of Public Health, University NOVA, Lisbon, Portugal.'}, {'ForeName': 'Antonio Filipe', 'Initials': 'AF', 'LastName': 'Macedo', 'Affiliation': 'Department and Center of Physics-Optometry and Vision Science, University of Minho, Braga, Portugal.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12665']
101,31699604,Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees: Feasibility and Acceptability Trial.,"PURPOSE


There are disparities in mental health of refugee youth compared with the general U.S.
POPULATION


We conducted a pilot feasibility and acceptability trial of the home-visiting Family Strengthening Intervention for refugees (FSI-R) using a community-based participatory research approach. The FSI-R aims to promote youth mental health and family relationships. We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families. We hypothesized that FSI-R would be feasible to implement and accepted by communities.
METHODS


A total of 40 Somali Bantu (n = 103 children, 58.40% female; n = 43 caregivers, 79.00% female) and 40 Bhutanese (n = 49 children, 55.30% female; n = 62 caregivers, 54.00% female) families were randomized to receive FSI-R or CAU. Refugee research assistants conducted psychosocial assessments pre- and post-intervention, and home visitors delivered the preventive intervention. Multilevel modeling assessed the effects of FSI-R. Feasibility was measured from retention, and acceptability was measured from satisfaction surveys.
RESULTS


The retention rate of 82.50% indicates high feasibility, and high reports of satisfaction (81.50%) indicate community acceptance. Across communities, FSI-R children reported reduced traumatic stress reactions, and caregivers reported fewer child depression symptoms compared with CAU families (β = -.42; p = .03; β = -.34; p = .001). Bhutanese FSI-R children reported reduced family arguing (β = -1.32; p = .04) and showed fewer depression symptoms and conduct problems by parent report (β = -9.20; p = .04; β = -.92; p = .01) compared with CAU. There were no significant differences by group on other measures.
CONCLUSIONS


A family-based home-visiting preventive intervention can be feasible and acceptable and has promise for promoting mental health and family functioning among refugees.",2020,We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families.,"['A total of 40 Somali Bantu (n\xa0= 103 children, 58.40% female; n\xa0= 43 caregivers, 79.00% female) and 40 Bhutanese (n\xa0= 49 children, 55.30% female; n\xa0= 62 caregivers, 54.00% female) families', 'Family-Based Mental Health Promotion for Somali Bantu and Bhutanese Refugees']","['FSI-R or CAU', 'home-visiting Family Strengthening Intervention']","['FSI-R. Feasibility', 'child depression symptoms', 'retention rate', 'depression symptoms and conduct problems', 'traumatic stress reactions']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337847', 'cui_str': 'Somalis (ethnic group)'}, {'cui': 'C0337826', 'cui_str': 'Bantu (ethnic group)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0337894', 'cui_str': 'Bhutanese (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}]","[{'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]",103.0,0.150707,We hypothesized that FSI-R families would have better psychosocial outcomes and family functioning postintervention compared with care-as-usual (CAU) families.,"[{'ForeName': 'Theresa S', 'Initials': 'TS', 'LastName': 'Betancourt', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts. Electronic address: theresa.betancourt@bc.edu.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Berent', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Rochelle L', 'Initials': 'RL', 'LastName': 'Frounfelker', 'Affiliation': 'Division of Social and Transcultural Psychiatry, Department of Psychiatry, McGill University, Montreal, Canada.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Brennan', 'Affiliation': ""Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts; Women's Studies Research Center, Brandeis University, Waltham, Massachusetts.""}, {'ForeName': 'Saida', 'Initials': 'S', 'LastName': 'Abdi', 'Affiliation': ""Refugee Trauma and Resilience Center, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Maalim', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Abdirahman', 'Initials': 'A', 'LastName': 'Abdi', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Tej', 'Initials': 'T', 'LastName': 'Mishra', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Bhuwan', 'Initials': 'B', 'LastName': 'Gautam', 'Affiliation': 'Research Program on Children and Adversity, Boston College School of Social Work, Chestnut Hill, Massachusetts.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Creswell', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, St. Ann Arbor, Michigan; College of Education and Human Services, University of Nebraska-Lincoln, Lincoln, Nebraska.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Beardslee', 'Affiliation': ""College of Education and Human Services, University of Nebraska-Lincoln, Lincoln, Nebraska; Judge Baker Children's Center, Harvard University, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.08.023']
102,31867637,Effects of Very Low Nicotine Content Cigarettes on Smoking Behavior and Biomarkers of Exposure in Menthol and Non-menthol Smokers.,"INTRODUCTION


Because 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a nicotine reduction policy.
METHODS


In a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low nicotine cigarettes (VLNC; 0.4 mg nicotine/g tobacco) or normal nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of nicotine content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence.
RESULTS


At baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps < .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition.
CONCLUSIONS


Although menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers.
IMPLICATIONS


Results of this analysis suggest that smokers of menthol cigarettes may respond to a nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes.",2019,"At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06).","['non-treatment-seeking smokers', 'in Menthol and Non-menthol Smokers']","['Very Low Nicotine Content Cigarettes', 'menthol or non-menthol cigarettes', 'low nicotine cigarettes (VLNC; 0.4 mg nicotine/g tobacco) or normal nicotine cigarettes (NNC']","['Odds ratios for abstinence', 'CO', 'Smoking Behavior and Biomarkers of Exposure', 'smoking fewer CPD', 'nicotine content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]",,0.0285442,"At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps < .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06).","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kotlyar', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, University of Minnesota College of Pharmacy, Minneapolis, MN.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Masonic Cancer Center and Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Masonic Cancer Center and Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Ikuemonisan', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Baptist Comprehensive Cancer Center and Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz160']
103,31628475,Smoking Topography Characteristics During a 6-Week Trial of Very Low Nicotine Content Cigarettes in Smokers With Serious Mental Illness.,"INTRODUCTION


A nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low nicotine content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI.
AIMS AND METHODS


After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg nicotine per g tobacco) or normal nicotine content (NNC; 15.8 mg nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates.
RESULTS


At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
CONCLUSIONS


Findings are consistent with acute VLNC cigarette topography studies and indicate that a nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI.
IMPLICATIONS


Given the high smoking rates among people with SMI, understanding how a nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if nicotine content is lowered to minimally addictive levels.",2020,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","['smokers with SMI (N=58', 'smokers with serious mental illness (SMI', 'smokers with serious mental illness', 'smokers with SMI']","['smoking very low nicotine content (VLNC) cigarettes', 'VLNC (0.4 mg nicotine/g tobacco) or normal nicotine content (NNC; 15.8 mg/g) research cigarettes for six weeks', 'nicotine content cigarettes', 'handheld smoking topography device']","['cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost', 'VLNC condition smoked fewer puffs per cigarette and had shorter inter-puff intervals']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0035168'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0729283', 'cui_str': 'Peak flow rate (respiratory)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0201706,"There were no differences between research cigarette conditions at Week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost.
","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Baptist Comprehensive Cancer Center and Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Rubin', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'DeAtley', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University, Providence, RI.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz198']
104,32145678,"Randomized control trial of evaluation of Clemastine effects on visual evoked potential, nerve fiber layer and ganglion cell layer complex in patients with optic neuritis.","OBJECTIVES


Optic neuritis (ON) is the most common cause of optic neuropathy; typically presenting with a unilateral visual loss in young adults, with incidence of 1-5 in 100,000 per year. We evaluated the effect of Clemastine, a first-generation and CNS (central nervous system)-penetrant H1 receptor antagonist on visual evoked potential (VEP), retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) complex in patients with optic neuritis.
PATIENTS AND METHODS


This is a prospective comparative interventional case series in 25 patients with acute optic neuritis. Patients were randomly assigned to group 1 (treated with Clemastine 1 mg orally twice a day for 90 days; 16 patients) or group 2 (received placebo for 90 days; 9 patients) and both groups received standard treatment of optic neuritis. We recorded VEP and peripapillary OCT (optical coherence tomography) of patients before and after three months of treatment.
RESULTS


In contrast to patients treated with Clemastine, RNFL thickness loss between base line phase and after three months follow up in control group were statistically significant in temporal, supra temporal, Infrotemporal and almost global sections of RNFL map. The reduction in GCL thickness between base line phase and after three months follow up in control group were significant, while it did not reach significance in treatment group except in inferior region.
CONCLUSION


In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group. In contrast to control group, p100 wave's amplitude recovered in a significant manner in treatment group.",2020,"In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group.","['patients with optic neuritis', '25 patients with acute optic neuritis']","['Clemastine', 'Clemastine, a first-generation and CNS (central nervous system)-penetrant H1 receptor antagonist', 'placebo']","['GCL thickness', 'RNFL thickness loss', 'VEP and peripapillary OCT (optical coherence tomography', 'RNFL and GCL thickness', 'visual evoked potential, nerve fiber layer and ganglion cell layer complex', 'visual evoked potential (VEP), retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) complex']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029134', 'cui_str': 'Optic Neuritis'}]","[{'cui': 'C0008929', 'cui_str': 'Clemastine'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0034814', 'cui_str': 'Receptors, H1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0442163', 'cui_str': 'Peripapillary (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0228071', 'cui_str': 'Ganglion cell (cell)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",25.0,0.0182228,"In contrast to treatment group, RNFL and GCL thickness of most quadrants are decreased significantly after three months in patients with ON in control group.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Moghaddasi', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nabovvati', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran. Electronic address: m.nabovvati@gmail.com.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Koushki', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Soltansanjari', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Sardarinia', 'Affiliation': 'Department of Ophthalmology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nafise', 'Initials': 'N', 'LastName': 'Mohebi', 'Affiliation': 'Department of Neurology, Hazrat Rasool Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedhossein', 'Initials': 'S', 'LastName': 'Rabani', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105741']
105,32330548,Motivational interviewing to prevent early childhood caries: A randomized controlled trial.,"OBJECTIVES


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


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


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


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


The findings of this study provide much needed evidence for dentists, dental auxiliary staff and public health workers to select effective intervention to empower parents for improving children's oral health behaviors and preventing early childhood caries.",2020,Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05).,"['early childhood caries', '692 parent-child dyads', '655', 'children aged 3-4 years with unfavorable oral health behaviors']","['PE, PE\u2009+\u2009MI, and PE\u2009+\u2009MI\u2009+\u2009RA', 'motivational interviewing (MI) and a patient communication tool featuring interactive caries risk assessment (RA) into PE', 'Motivational interviewing']","[""Children's oral hygiene status and dental caries"", ""parental efficacy and children's oral health behaviors"", 'Caries increment', ""children's oral health behaviors"", 'plaque score']","[{'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0564415,Significantly greater improvements were found in parental efficacy and children's oral health behaviors in PE + MI and PE + MI + RA groups than in PE group (all p < 0.05).,"[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Edward Cm', 'Initials': 'EC', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Samuel My', 'Initials': 'SM', 'LastName': 'Ho', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Faculty of Dentistry & Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: dengx@nus.edu.sg.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103349']
106,32327254,Application of Automated Quantification of Fluid Volumes to Anti-VEGF Therapy of Neovascular Age-Related Macular Degeneration.,"PURPOSE


Anti-vascular endothelial growth factor (VEGF) treatment of neovascular age-related macular degeneration (AMD) is a highly effective advance in the retinal armentarium. OCT offering 3-dimensional imaging of the retina is widely used to guide treatment. Although poor outcomes reported from clinical practice are multifactorial, availability of reliable, reproducible, and quantitative evaluation tools to accurately measure the fluid response, that is, a ""VEGF meter,"" may be a better means of monitoring and treating than the current purely qualitative evaluation used in clinical practice.
DESIGN


Post hoc analysis of a phase III, randomized, multicenter study.
PARTICIPANTS


Study eyes of 1095 treatment-naive subjects receiving pro re nata (PRN) or monthly ranibizumab therapy according to protocol-specified criteria in the HARBOR study.
METHODS


A deep learning method for localization and quantification of fluid in all retinal compartments was applied for automated segmentation of fluid with every voxel classified by a convolutional neural network (CNN). Three-dimensional volumes (nanoliters) for intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED) were determined in 24 362 volume scans obtained from 1095 patients treated over 24 months in a phase III clinical trial with randomization to 2 drug dosages (0.5 mg and 2.0 mg ranibizumab) and 2 regimens (monthly and PRN). A multivariable mixed-effects regression model was used to test for differences in fluid between the arms and for fluid/function correlation.
MAIN OUTCOME MEASURES


Fluid volume in nanoliters, structure-function as Pearson's correlation coefficient, and as a coefficient of determination (R 2 ).
RESULTS


Fluid volumes were quantified in all visits of all patients. Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: Intraretinal fluid showed the greatest and most rapid resolution, followed by SRF and PED the least. The loading dose treatment achieved resolution of all fluid types close to the lowest levels attainable. Dosage and regimen parameters correlated directly with resulting fluid volumes. Fluid/function correlation showed a volume-dependent negative impact of IRF on vision and weak positive prognostic effect of SRF.
CONCLUSIONS


Automated quantification of the fluid response may improve therapeutic management of neovascular AMD, avoid discrepancies between clinicians/investigators, and establish structure/function correlations.",2020,"Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: Intraretinal fluid showed the greatest and most rapid resolution, followed by SRF and PED the least.","['Study eyes of 1095 treatment-naive subjects receiving pro re nata (PRN) or monthly ranibizumab therapy according to protocol-specified criteria in the HARBOR study', 'neovascular age-related macular degeneration (AMD', 'Neovascular Age-Related Macular Degeneration']","['Anti-vascular endothelial growth factor (VEGF', 'ranibizumab']","[""Fluid volume in nanoliters, structure-function as Pearson's correlation coefficient, and as a coefficient of determination (R 2 "", 'intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0560008', 'cui_str': 'nL'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}]",,0.0677886,"Automated segmentation demonstrated characteristic response patterns for each fluid compartment individually: Intraretinal fluid showed the greatest and most rapid resolution, followed by SRF and PED the least.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria. Electronic address: ursula.schmidt-erfurth@meduniwien.ac.at.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Vogl', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lee Merrill', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Bogunović', 'Affiliation': 'Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.010']
107,31321423,"A Randomized Clinical Trial of Snus Examining the Effect of Complete Versus Partial Cigarette Substitution on Smoking-Related Behaviors, and Biomarkers of Exposure.","INTRODUCTION


This 8-week multisite, randomized controlled trial of snus examined the differential effects of instructions on (1) snus use, (2) smoking and smoking-related measures, and (3) exposure to tobacco-related constituents.
METHOD


US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York. Following a 1-week sampling phase of snus, participants who used at least 7 pouches were randomized to either (1) partial substitution (PS; ""use snus as you like with your cigarettes""), (2) complete substitution (CS; ""avoid cigarettes""), or (3) usual brand cigarettes (UB). Analyses included between-group analyses (eg, PS vs. CS) using Wilcoxon rank sum test of cigarettes per day and snus pouches per day, and a linear mixed model (biomarkers).
RESULTS


Compared to the PS and UB groups, smokers assigned to CS reported greater reductions in cigarettes per day (ps < .001), using more snus pouches per day (p = .02), and more smoke-free days (CS median = 14.5, PS and UB medians = 0, p < .001). In addition, results demonstrated reductions in carbon monoxide (p < .001), total nicotine equivalents (p = .02), and four out of five measured volatile organic compounds (ps < .01) over time among the CS group. Exposure to N'-nitrosonornicotine increased by trial end only among the PS group (p < .04). Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups.
CONCLUSIONS


Instructions to completely switch from cigarettes to snus resulted in the greatest reduction in cigarettes and exposure to harmful constituents.
IMPLICATIONS


Directly instructing smokers to switch completely to snus, rather than using ad libitum (with no instructions to avoid cigarettes), is necessary for reductions in smoking and subsequent exposure to harmful constituents.",2020,"Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups.
","['participants who used at least 7 pouches', 'US adult daily cigarette smokers (n = 150; 43.3% female; Medianage = 43.5) were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio; and Buffalo, New York']","[""N'-nitrosonornicotine"", 'partial substitution (PS; ""use snus as you like with your cigarettes""), (2) complete substitution (CS; ""avoid cigarettes""), or (3) usual brand cigarettes (UB', 'Complete Versus Partial Cigarette Substitution']","['Smoking-Related Behaviors, and Biomarkers of Exposure', 'Phenanthrene tetraol', 'total nicotine equivalents', 'carbon monoxide']","[{'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1739095', 'cui_str': 'Bos bison'}, {'cui': 'C0027976', 'cui_str': 'New York'}]","[{'cui': 'C0067113', 'cui_str': 'N-nitrosonor-nicotine'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4288198', 'cui_str': 'Snus'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3181403', 'cui_str': 'phenanthrene tetraol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.0376759,"Phenanthrene tetraol increased among all groups by trial end (p = .02) with no difference between groups.
","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Wisconsin-Stevens Point, WI.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Lindgren', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reisinger', 'Affiliation': 'College of Medicine, Ohio State University, Columbus, OH.'}, {'ForeName': 'Kaila J', 'Initials': 'KJ', 'LastName': 'Norton', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Strayer', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dick', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Mei-Kuen', 'Initials': 'MK', 'LastName': 'Tang', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Menglan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Carmella', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Stepanov', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'Connor"", 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Shields', 'Affiliation': 'College of Medicine, Ohio State University, Columbus, OH.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Comprehensive Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz055']
108,32323119,Testing the cross-stressor hypothesis under real-world conditions: exercise as a moderator of the association between momentary anxiety and cardiovascular responses.,"The cross-stressor adaptation hypothesis of exercise training has not been investigated under real-life conditions. Using ecological momentary assessment, we tested whether usual exercise level moderates the relationship of self-reported anxiety to concurrent ambulatory heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP). Participants (N = 832) completed 24-h ambulatory monitoring of HR/BP, using a brachial BP cuff that took readings at 28-min intervals. Anxiety levels were concurrently reported on a visual analog scale (VAS) using a Palm Pilot. Usual exercise behavior was assessed by a self-report questionnaire. Random coefficients linear regression models predicting momentary HR/BP readings from time-matched anxiety scores were estimated, yielding the average within-person effect (slope) of anxiety. The interaction of exercise level (i.e., no weekly exercise, 1-149, and ≥ 150 min/week; a between-person factor) with anxiety was added to the model in order to estimate the average anxiety slope for participants in each exercise category. The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis. In an exploratory analysis of the difference in HR/BP between occasions when anxiety was in the top versus bottom person-specific quintiles of responses, the difference in HR (but not SBP or DBP) varied significantly by exercise level (F(2,625) = 4.92, p = 0.008). Though our pre-specified analysis did not support the hypothesis, we provide some post hoc evidence supporting the cross-stressor hypothesis of exercise training for the HR response to anxiety.",2020,"The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis.",[],['exercise training'],"['visual analog scale (VAS', 'HR/BP to anxiety', 'Usual exercise behavior', '24-h ambulatory monitoring of HR/BP, using a brachial BP cuff that took readings', 'HR/BP', 'Anxiety levels', 'usual exercise level moderates the relationship of self-reported anxiety to concurrent ambulatory heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP']",[],"[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242882', 'cui_str': 'Ambulatory Monitoring'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",,0.0208932,"The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis.","[{'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Ensari', 'Affiliation': 'Data Science Institute, Columbia University, 475 Riverside Dr, Room 320, New York, NY, 10115, USA. ie2145@columbia.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Edmondson', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Duran', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Diaz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00155-0']
109,32112730,Prelabor screening at term using the cerebroplacental ratio and placental growth factor: a pragmatic randomized open-label phase 2 trial.,"BACKGROUND AND OBJECTIVE


In some women placental function may not be adequate to meet fetal growth requirements in late pregnancy or the additional demands during labor, thus predisposing these infants to intrapartum fetal compromise and subsequent serious morbidity and mortality. The objective of this study was to determine if the introduction of a prelabor screening test at term combining the cerebroplacental ratio and maternal placental growth factor level would result in a reduction in a composite of adverse outcomes.
STUDY DESIGN


Single-site, nonblinded, randomized controlled trial conducted at a tertiary hospital in Brisbane, Australia. Eligible women were randomized to either receive the screening test performed between 37-38 weeks or routine obstetric care. Screen-positive women were offered induction of labor. The primary outcome was a composite of emergency cesarean delivery for nonreassuring fetal status (fetal distress) or severe neonatal acidosis or low Apgar score or stillbirth or neonatal death.
RESULTS


Women were recruited and randomized (n = 501) between April 2017 and January 2019. Sixty-three of 249 subjects (25.3%) in the screened group compared to 56 of 252 (22.2%) in the control group experienced the primary outcome (relative risk = 1.14 [95% confidence interval, 0.83-1.56]; P = .418). Women who screened positive were more likely to require operative delivery for fetal distress, have meconium-stained liquor, have pathologic fetal heart rate abnormalities, and have infants with lower birthweight compared to women that screened negative.
CONCLUSION


The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes. However, it did show discriminatory potential, and future research should focus on refining the thresholds used.",2020,The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes.,"['Women were recruited and randomized (n=501) between April 2017 to January 2019', 'Eligible women', 'Single-site, non-blinded, randomized controlled trial conducted at a tertiary hospital in Brisbane, Australia']","['Pre-labor screening', 'screening test performed between 37-38 weeks or routine obstetric care']","['birth weight', 'composite of: emergency cesarean for non-reassuring fetal status (fetal distress) or severe neonatal acidosis or low Apgar score or stillbirth or neonatal death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring Fetal Status'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4544436', 'cui_str': 'Neonatal acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}]",,0.166963,The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes.,"[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Sherrell', 'Affiliation': 'Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Vicki L', 'Initials': 'VL', 'LastName': 'Clifton', 'Affiliation': 'Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia; Mater Mothers' Hospital, Brisbane, Queensland, Australia; Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.034']
110,32330107,"A Pre-Workout Supplement of Ketone Salts, Caffeine, and Amino Acids Improves High-Intensity Exercise Performance in Keto-Naïve and Keto-Adapted Individuals.","Background:  Acute ingestion of ketone supplements alters metabolism and potentially exercise performance. No studies to date have evaluated the impact of co-ingestion of ketone salts with caffeine and amino acids on high intensity exercise performance, and no data exists in Keto-Adapted individuals. Methods:  We tested the performance and metabolic effects of a pre-workout supplement containing beta-hydroxybutyrate (BHB) salts, caffeine, and amino acids (KCA) in recreationally-active adults habitually consuming a mixed diet (Keto-Naïve; n = 12) or a ketogenic diet (Keto-Adapted; n = 12). In a randomized and balanced manner, subjects consumed either the KCA consisting of ∼7 g BHB (72% R-BHB and 28% S-BHB) with ∼100 mg of caffeine, and amino acids (leucine and taurine) or Water (control condition) 15 minutes prior to performing a staged cycle ergometer time to exhaustion test followed immediately by a 30 second Wingate test. Results:  Circulating total BHB concentrations increased rapidly after KCA ingestion in KN (154 to 732 μM) and KA (848 to 1,973 μM) subjects and stayed elevated throughout recovery in both groups. Plasma S-BHB increased >20-fold 15 minutes after KCA ingestion in both groups and remained elevated throughout recovery. Compared to Water, KCA ingestion increased time to exhaustion 8.3% in Keto-Naïve and 9.8% in Keto-Adapted subjects (P < 0.001). There was no difference in power output during the Wingate test between trials. Peak lactate immediately after exercise was higher after KCA (∼14.9 vs 12.7 mM). Conclusion:  These results indicate that pre-exercise ingestion of a moderate dose of R- and S-BHB salts combined with caffeine, leucine and taurine improves high-intensity exercise performance to a similar extent in both Keto-Adapted and Keto-Naïve individuals.",2020,"Circulating total BHB concentrations increased rapidly after KCA ingestion in KN (154 to 732 μM) and KA (848 to 1,973 μM) subjects and stayed elevated throughout recovery in both groups.","['Keto-Naïve and Keto-Adapted Individuals', 'recreationally-active adults habitually consuming a mixed diet (Keto-Naïve; n\u2009=\u200912) or a']","['Ketone Salts, Caffeine, and Amino Acids', 'ketogenic diet (Keto-Adapted; n\u2009=\u200912', 'ketone supplements', 'caffeine and amino acids', 'caffeine, and amino acids (leucine and taurine) or Water (control condition', 'caffeine, leucine and taurine', 'pre-workout supplement containing beta-hydroxybutyrate (BHB) salts, caffeine, and amino acids (KCA']","['Plasma S-BHB', 'Circulating total BHB concentrations', 'high-intensity exercise performance', 'power output', 'Peak lactate']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0468378,"Circulating total BHB concentrations increased rapidly after KCA ingestion in KN (154 to 732 μM) and KA (848 to 1,973 μM) subjects and stayed elevated throughout recovery in both groups.","[{'ForeName': 'Madison L', 'Initials': 'ML', 'LastName': 'Kackley', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Short', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Parker N', 'Initials': 'PN', 'LastName': 'Hyde', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'LaFountain', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buga', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Miller', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Teryn N', 'Initials': 'TN', 'LastName': 'Sapper', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Barnhart', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Krishnan', 'Affiliation': 'College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'McElroy', 'Affiliation': 'College of Pharmacy, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, Ohio, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1752846']
111,31566888,Motor learning and transfer between real and virtual environments in young people with autism spectrum disorder: A prospective randomized cross over controlled trial.,"Autism spectrum disorder (ASD) is associated with persistent deficits in social communication and social interaction, including impaired multisensory integration, which might negatively impact cognitive and motor skill performance, and hence negatively affect learning of tasks. Considering that tasks in virtual environment may provide an engaging tool as adjuncts to conventional therapies, we set out to compare motor performance between young people with ASD and a typically developing (TD) control group that underwent coincident timing tasks based on Kinect (no physical contact) and on Keyboard (with physical contact) environments. Using a randomized repeated cross-over controlled trial design, 50 young people with ASD and 50 with TD, matched by age and sex were divided into subgroups of 25 people that performed the two first phases of the study (acquisition and retention) on the same device-real or virtual-and then switched to the other device to repeat acquisition and retention phases and finally switched on to a touch screen (transfer phase). Results showed that practice in the virtual task was more difficult (producing more errors), but led to a better performance in the subsequent practice in the real task, with more pronounced improvement in the ASD as compared to the TD group. It can be concluded that the ASD group managed to transfer the practice from a virtual to a real environment, indicating that virtual methods may enhance learning of motor and cognitive skills. A need for further exploration of its effect across a number of tasks and activities is warranted. Autism Res 2020, 13: 307-319. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Individuals with autism spectrum disorder are known to have difficulties with learning motor tasks. Considering that performing motor tasks in virtual environment may be an engaging tool as adjuncts to conventional therapies, we aimed to estimate performance in tasks regardless of physical touch. Results showed that participants had more difficulty using the non-touch task; however, virtual training improved performance on the physical (real) task. This result indicates that virtual methods could be a promising therapeutic approach for the ASD population.",2020,"Results showed that practice in the virtual task was more difficult (producing more errors), but led to a better performance in the subsequent practice in the real task, with more pronounced improvement in the ASD as compared to the TD group.","['young people with autism', 'Individuals with autism spectrum disorder', 'young people with ASD', '50 young people with ASD and 50 with TD, matched by age and sex were divided into subgroups of 25 people that performed the two first phases of the study (acquisition and retention) on the', 'spectrum disorder', 'Autism spectrum disorder (ASD']","['same device-real or virtual-and then switched to the other device to repeat acquisition and retention phases and finally switched on to a touch screen (transfer phase', 'Motor learning and transfer between real and virtual environments']",[],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],50.0,0.0624477,"Results showed that practice in the virtual task was more difficult (producing more errors), but led to a better performance in the subsequent practice in the real task, with more pronounced improvement in the ASD as compared to the TD group.","[{'ForeName': 'Íbis Ariana Peña', 'Initials': 'ÍAP', 'LastName': 'de Moraes', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Carlos Bandeira de Mello', 'Initials': 'CBM', 'LastName': 'Monteiro', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Talita Dias da', 'Initials': 'TDD', 'LastName': 'Silva', 'Affiliation': 'Post-Graduate Programme in Rehabilitation Sciences, Faculty of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Massetti', 'Affiliation': 'Post-Graduate Programme in Rehabilitation Sciences, Faculty of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Tânia Brusque', 'Initials': 'TB', 'LastName': 'Crocetta', 'Affiliation': 'Department of Morphology and Physiology, Faculty of Medicine of ABC, Santo André, SP, Brazil.'}, {'ForeName': 'Lilian Del Ciello', 'Initials': 'LDC', 'LastName': 'de Menezes', 'Affiliation': 'Post-Graduate Programme in Rehabilitation Sciences, Faculty of Medicine, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Gilda Pena de Rezende', 'Initials': 'GPR', 'LastName': 'Andrade', 'Affiliation': 'Integrated Psycho-pedagogical Support Group (GAPI) Special Education School in São Bernardo do Campo, São Paulo, Brazil.'}, {'ForeName': 'Alessandro Hervaldo Nicolai', 'Initials': 'AHN', 'LastName': 'Ré', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Institute of Nursing and Allied Health Research, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Coe', 'Affiliation': 'Department of Clinical Neurology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Henrique', 'Initials': 'FH', 'LastName': 'Magalhães', 'Affiliation': 'School of Arts, Sciences and Humanities, University of São Paulo, São Paulo, SP, Brazil.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2208']
112,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
113,32114612,Decreasing Delirium Through Music: A Randomized Pilot Trial.,"BACKGROUND


Management of delirium in intensive care units is challenging because effective therapies are lacking. Music is a promising nonpharmacological intervention.
OBJECTIVES


To determine the feasibility and acceptability of personalized music (PM), slow-tempo music (STM), and attention control (AC) in patients receiving mechanical ventilation in an intensive care unit, and to estimate the effect of music on delirium.
METHODS


A randomized controlled trial was performed in an academic medical-surgical intensive care unit. After particular inclusion and exclusion criteria were applied, patients were randomized to groups listening to PM, relaxing STM, or an audiobook (AC group). Sessions lasted 1 hour and were given twice daily for up to 7 days. Patients wore noise-canceling headphones and used mp3 players to listen to their music/audiobook. Delirium and delirium severity were assessed twice daily by using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the CAM-ICU-7, respectively.
RESULTS


Of the 1589 patients screened, 117 (7.4%) were eligible. Of those, 52 (44.4%) were randomized, with a recruitment rate of 5 patients per month. Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable. The median number (interquartile range) of delirium/coma-free days by day 7 was 2 (1-6) for PM, 3 (1-6) for STM, and 2 (0-3) for AC (P = .32). Median delirium severity was 5.5 (1-7) for PM, 3.5 (0-7) for STM, and 4 (1-6.5) for AC (P = .78).
CONCLUSIONS


Music delivery is acceptable to patients and is feasible in intensive care units. Further research testing use of this promising intervention to reduce delirium is warranted.",2020,"Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable.","['Of the 1589 patients screened, 117 (7.4%) were eligible', 'patients receiving mechanical ventilation in an intensive care unit', 'academic medical-surgical intensive care unit']","['Music', 'listening to PM, relaxing STM, or an audiobook (AC group', 'noise-canceling headphones and used mp3 players to listen to their music/audiobook', 'personalized music (PM), slow-tempo music (STM), and attention control (AC']","['Delirium and delirium severity', 'Adherence', 'Median delirium severity', 'median number (interquartile range) of delirium/coma-free days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205544', 'cui_str': 'Canceled (qualifier value)'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}, {'cui': 'C2350433', 'cui_str': 'MP3-Player'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.285442,"Adherence was higher in the groups listening to music (80% in the PM and STM groups vs 30% in the AC group; P = .01), and 80% of patients surveyed rated the music as enjoyable.","[{'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Sikandar H. Khan is an assistant professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and a scientist, Center for Aging Research, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Chenjia', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chenjia Xu is a doctoral student.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Purpura', 'Affiliation': 'Russell Purpura is an internal medicine resident, Department of Medicine, Indiana University School of Medicine.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Sana Durrani is a research associate, Center for Aging Research, Indiana University.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Heidi Lindroth is a T32 postdoctoral fellow, Center for Aging Research, Indiana University, and a postdoctoral fellow, Indiana University School of Nursing.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant professor, Department of Psychiatry, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Heiderscheit', 'Affiliation': 'Annie Heiderscheit is an associate professor of music and director of music therapy, Augsburg University, Minneapolis, Minnesota.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chlan', 'Affiliation': 'Linda Chlan is a professor, Department of Nursing, and associate dean, Nursing Research Division, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Malaz Boustani is a professor of medicine, Center for Aging Research, Indiana University, and a scientist, Center for Health Innovation and Implementation Science, Indianapolis, Indiana.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Babar A. Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and a scientist, Center for Aging Research, Indiana University.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020175']
114,32114617,Effect of Delirium on Physical Function in Noncardiac Thoracic Surgery Patients.,"BACKGROUND


The effect of delirium on physical function in patients undergoing noncardiac thoracic surgery has not been well described and may differ from that in other surgical populations.
OBJECTIVE


To determine the effects of delirium on muscle strength and functional independence. The primary end point was change in Medical Research Council sum score (MRC-SS) by delirium status.
METHODS


A secondary analysis of data from a clinical trial involving English-speaking adults aged 18 years or older who were undergoing major noncardiac thoracic surgery. Exclusion criteria were history of schizophrenia, Parkinson disease, dementia, alcohol abuse, or neuroleptic malignant syndrome; haloperidol allergy; being pregnant or nursing; QT prolongation; and taking levodopa or cholinesterase inhibitors. Delirium was assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit. Preoperatively and postoperatively, muscle strength was assessed using the modified MRC-SS and functional independence was assessed using the Katz scale of activities of daily living. Changes in MRC-SS and Katz score by delirium status were analyzed using the Fisher exact test.
RESULTS


Seventy-three patients were included in the analysis. Median (interquartile range) MRC-SS and Katz score before surgery did not differ significantly between patients without and with delirium (MRC-SS: 30 [30-30] vs 30 [30-30], P > .99; Katz score: 6 [6-6] vs 6 [6-6], P = .63). The percentage of patients with a change in MRC-SS was similar in patients without and with delirium (17% vs 13%, respectively; P > .99). More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
CONCLUSIONS


Postoperative delirium was not associated with change in muscle strength. Follow-up studies using other muscle measures may be needed.",2020,"More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
","['Exclusion criteria were history of schizophrenia, Parkinson disease, dementia, alcohol abuse, or neuroleptic malignant syndrome', 'patients undergoing noncardiac thoracic surgery', 'Seventy-three patients were included in the analysis', 'English-speaking adults aged 18 years or older who were undergoing major noncardiac thoracic surgery', 'Noncardiac Thoracic Surgery Patients']","['Delirium', 'delirium', 'levodopa or cholinesterase inhibitors', 'haloperidol']","['MRC-SS and Katz score by delirium status', 'MRC-SS', 'modified MRC-SS and functional independence', 'muscle strength', 'Katz scale of activities of daily living', 'Katz score', 'Delirium', 'Median (interquartile range) MRC-SS and Katz score', 'change in Medical Research Council sum score (MRC-SS) by delirium status', 'muscle strength and functional independence']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0455502', 'cui_str': 'H/O: schizophrenia'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C1869046', 'cui_str': 'Neuroleptic malignant syndrome (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C4521309', 'cui_str': 'Cholinesterase inhibitor (disposition)'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0222045'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]",73.0,0.148846,"More patients in the delirium group had a change in Katz score (13% vs 0%, P = .04).
","[{'ForeName': 'Sikandar H', 'Initials': 'SH', 'LastName': 'Khan', 'Affiliation': 'Sikandar H. Khan is an assistant research professor.'}, {'ForeName': 'Chenjia', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chenjia Xu is a doctoral student.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant clinical professor, Department of Psychiatry, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lasiter', 'Affiliation': 'Sue Lasiter is an associate professor, University of Missouri-Kansas City School of Nursing and Health Studies, Kansas City, Missouri.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kesler', 'Affiliation': 'Kenneth Kesler is a professor, Department of Cardiothoracic Surgery, Indiana University School of Medicine.'}, {'ForeName': 'Babar A', 'Initials': 'BA', 'LastName': 'Khan', 'Affiliation': 'Babar A. Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, and IU Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020579']
115,32327255,Visual Field Outcomes in the Tube Versus Trabeculectomy Study.,"PURPOSE


To describe visual field (VF) outcomes in the Tube Versus Trabeculectomy (TVT) Study.
DESIGN


Cohort analysis of patients in a multicenter randomized clinical trial.
PARTICIPANTS


A total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups.
METHODS


The TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm 2  Baerveldt implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 4 minutes) in patients with previous cataract or glaucoma surgery. Enrolled patients underwent perimetry at baseline and annual follow-up visits. The VFs were included if the false-positive rate was ≤20% and false-negative rate was ≤35%. The VFs were excluded if visual acuity <20/400 or loss of ≥2 Snellen lines from baseline was attributed to an etiology other than glaucoma. Longitudinal linear mixed-effects models with best linear unbiased predictions (BLUPs) were applied to estimate rates of change in mean deviation (MD) for each treatment group.
MAIN OUTCOME MEASURE


Rate of MD change during follow-up period.
RESULTS


A total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was -13.07 ± 8.4 decibels (dB) in the tube shunt group and -13.18 ± 8.2 dB in the trabeculectomy group (P = 0.99). The rate of change in MD was -0.60 dB/year in the tube group and -0.38 dB/year in the trabeculectomy group (P = 0.34). The 95% confidence intervals for the rates of MD change were -0.77 to -0.44 dB/year in the tube group and -0.56 to -0.20 dB/year in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) <18 mmHg or by average IOP. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss.
CONCLUSIONS


Slow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.",2020,The rate of change in MD was -0.60 dB/year in the tube group and -0.38,"['A total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups', 'Enrolled patients underwent perimetry at baseline and annual follow-up visits', 'patients with previous cataract or glaucoma surgery']","['Tube Versus Trabeculectomy (TVT', 'tube shunt surgery (350-mm 2  Baerveldt implant) and trabeculectomy with mitomycin C (MMC']","['Rate of MD change during follow-up period', 'false-positive rate', 'rate of change in MD', 'Baseline MD', 'VF loss', 'rate of VF loss', 'rates of MD change', 'Visual Field Outcomes', 'severe VF loss', 'MD slope']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031061', 'cui_str': 'Perimetry'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0600545', 'cui_str': 'Baerveldt Implants'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3887875', 'cui_str': 'Visual field defect'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",436.0,0.137452,The rate of change in MD was -0.60 dB/year in the tube group and -0.38,"[{'ForeName': 'Swarup S', 'Initials': 'SS', 'LastName': 'Swaminathan', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Alessandro A', 'Initials': 'AA', 'LastName': 'Jammal', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Kornmann', 'Affiliation': 'Glaucoma Associates of Texas, Dallas, Texas.'}, {'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, University of Washington, Seattle, Washington.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Medeiros', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: sgedde@med.miami.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.02.034']
116,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND


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


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


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


PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
117,31701153,Very Low Nicotine Content Cigarettes Disrupt the Feedback Loop of Affective States and Smoking Behavior.,"INTRODUCTION


Smoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period.
AIMS AND METHODS


Participants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group.
RESULTS


We found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
CONCLUSIONS


Our results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking.
IMPLICATIONS


These findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.",2020,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
",['Participants (n=1250) were adult smokers from ten U.S. sites randomized to one of three groups'],"['nicotine per gram of tobacco [mg/g]), immediate nicotine reduction', 'gradual nicotine reduction', 'standard nicotine content cigarettes']",['cigarette consumption'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption (observable entity)'}]",,0.010842,"We found that both negative and positive affect were associated with cigarette consumption in the control group but not in the gradual or immediate reduction groups across the 20 weeks of exposure.
","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kypriotakis', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""Al'absi"", 'Affiliation': 'Department of Family Medicine and BioBehavioral Health, University of Minnesota Medical School, Duluth, MN.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Leischow', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lori G', 'Initials': 'LG', 'LastName': 'Strayer', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Cancer Prevention and Control, Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz209']
118,32323046,SOLACE: A Psychosocial Stigma Protection Intervention to Improve the Mental Health of Parents of Autistic Children-A Feasibility Randomised Controlled Trial.,"This study presents findings from a feasibility trial, testing an 8-week psychosocial stigma protection intervention (SOLACE) designed to improve the mental health of parents of autistic children. Seventeen parents were stratified then randomly assigned to either SOLACE (n = 9) or control group (n = 8). Retention and adherence rates were excellent with minimal missing data suggesting SOLACE had good acceptability and feasibility. Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants. In addition, changes in secondary outcome measures (e.g. stigma, self-esteem and self-compassion) were in favour of SOLACE. Focus group interviews revealed that SOLACE was acceptable to parents. Results suggest that a full randomised controlled trial is warranted.",2020,Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants.,"['Parents of Autistic Children', 'Seventeen parents', 'parents of autistic children']","['psychosocial stigma protection intervention (SOLACE', 'SOLACE', 'Psychosocial Stigma Protection Intervention']","['Retention and adherence rates', 'good acceptability and feasibility', 'stigma, self-esteem and self-compassion', 'mental health scores']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0862396,Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants.,"[{'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Lodder', 'Affiliation': 'Institute for Health Research, University of Bedfordshire, Putteridge Bury, Hitchin Road, Luton, LU2 8LE, UK. annemarie.lodder@beds.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Papadopoulos', 'Affiliation': 'Institute for Health Research, University of Bedfordshire, Putteridge Bury, Hitchin Road, Luton, LU2 8LE, UK.'}, {'ForeName': 'Gurch', 'Initials': 'G', 'LastName': 'Randhawa', 'Affiliation': 'Institute for Health Research, University of Bedfordshire, Putteridge Bury, Hitchin Road, Luton, LU2 8LE, UK.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04498-0']
119,30335180,Effectiveness of Village Health Worker-Delivered Smoking Cessation Counseling in Vietnam.,"INTRODUCTION


Smoking prevalence is high in Vietnam, yet tobacco dependence treatment (TDT) is not widely available.
METHODS


We conducted a quasiexperimental study that compared the effectiveness of health care provider advice and assistance (ARM 1) versus ARM 1 plus village health worker (VHW) counseling (ARM 2) on abstinence at 6-month follow-up. This study was embedded in a larger two-arm cluster randomized controlled trial conducted in 26 community health centers (CHCs) in Vietnam. Subjects (N = 1318) were adult patients who visited any participating CHC during the parent randomized controlled trial intervention period and were self-identified as current tobacco users (cigarettes and/or water pipe).
RESULTS


At 6-month follow-up, abstinences rates in ARM 2 were significantly higher than those in ARM 1 (25.7% vs. 10.5%; p < .001). In multivariate analyses, smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR] = 2.96, 95% confidence interval [CI] = 1.78% to 4.92%). Compared to cigarette-only smokers, water pipe-only smokers (AOR = 0.4, 95% CI = 0.26% to 0.62%) and dual users (AOR = 0.62, 95% CI = 0.45% to 0.86%) were less likely to achieve abstinence; however, the addition of VHW counseling (ARM 2) was associated with higher quit rates compared with ARM 1 alone for all smoker types.
CONCLUSION


A team approach in TDT programs that offer a referral system for health care providers to refer smokers to VHW-led cessation counseling is a promising and potentially scalable model for increasing access to evidence-based TDT and increasing quit rates in low middle-income countries (LMICs). TDT programs may need to adapt interventions to improve outcomes for water pipe users.
IMPLICATIONS


The study fills literature gaps on effective models for TDT in LMICs. The addition of VHW-led cessation counseling, available through a referral from primary care providers in CHCs in Vietnam, to health care provider's brief cessation advice, increased 6-month biochemically validated abstinence rates compared to provider advice alone. The study also demonstrated the potential effectiveness of VHW counseling on reducing water pipe use. For LMICs, TDT programs in primary care settings with a referral system to VHW-led cessation counseling might be a promising and potentially scalable model for increasing access to evidence-based treatment.",2019,"In multivariate analyses smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR]=2.96, 95% confidence interval [CI]=1.78-4.92).","['Subjects (N=1,318) were adult patients who visited any participating CHC during the parent RCT intervention period and were self-identified as current tobacco users (cigarettes and/or waterpipe', '26 community health centers (CHCs) in Viet Nam', 'Viet Nam']","['village health worker delivered smoking cessation counseling', 'health care provider advice and assistance (ARM 1) vs. ARM 1 plus village health worker (VHW) counseling (ARM 2']",['quit rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]","[{'cui': 'C0087157', 'cui_str': 'Village Health Workers'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],1318.0,0.0678612,"In multivariate analyses smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR]=2.96, 95% confidence interval [CI]=1.78-4.92).","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health, New York University, New York, NY.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Siman', 'Affiliation': 'Department of Population Health, New York University, New York, NY.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Cleland', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Van Devanter', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, New York University, New York, NY.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty216']
120,32320285,Dexamethasone Sodium Phosphate Penetration During Phonophoresis at 2 Ultrasound Frequencies.,"CONTEXT


The effect of ultrasound frequency on phonophoresis drug delivery in humans is unknown.
OBJECTIVE


To determine if a low (45-kHz) or high (1-MHz) frequency delivered a higher dexamethasone (Dex) concentration through the skin.
DESIGN


Controlled laboratory study.
SETTING


Laboratory.
PATIENTS OR OTHER PARTICIPANTS


A total of 40 healthy men between the ages of 18 and 45 years (age = 23.1 ± 2.6 years, height = 176.1 ± 7.2 cm, mass = 88.5 ± 19.4 kg, posterior calf subcutaneous thickness measured using musculoskeletal ultrasound imaging = 0.6 ± 0.2 cm).
INTERVENTION(S)


Participants were randomly assigned to 1 of 4 groups (ultrasound frequency at microdialysis probe depth): (1) 45-kHz frequency at 1 mm, (2) 45-kHz frequency at 4 mm, (3) 1-MHz frequency at 1 mm, or (4) 1-MHz frequency at 4 mm (n = 10 in each group). Three linear microdialysis probes were inserted at the desired tissue depth. We rubbed dexamethasone sodium phosphate (Dex-P) into the skin and then applied a 15-minute phonophoresis treatment.
MAIN OUTCOME MEASURE(S)


Dialysate was collected during the treatment and 60 minutes posttreatment and analyzed for Dex-P, Dex, and the metabolite form of Dex. The sum of the 3 analytes was calculated as total dexamethasone (Dex-total), and differences between the 45-kHz and 1-MHz treatment groups were determined by a repeated-measures analysis of variance.
RESULTS


At 1 mm, 3 (30%) participants in the 45-kHz and 4 (40%) participants in the 1-MHz group had measurable levels of Dex-P. Total dexamethasone increased after the treatment ceased, independent of ultrasound frequency (P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration (P = .006). At 4 mm, 5 (50%) participants in the 45-kHz and 1 (10%) participant in the 1-MHz group had measurable levels of Dex-P. We observed no difference in Dex-total concentration between treatment groups at 4 mm (P = .72).
CONCLUSIONS


Phonophoresis provided a mechanism for Dex-total delivery at the 1- and 4-mm tissue depths. However, the effectiveness of the ultrasound frequencies varied between the 2 measured tissue depths.",2020,"P  < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration ( P  = .006).","['40 healthy men between the ages of 18 and 45 years (age = 23.1 ± 2.6 years, height = 176.1 ± 7.2 cm, mass = 88.5 ± 19.4 kg, posterior calf subcutaneous thickness measured using musculoskeletal imaging ultrasound = 0.6 ± 0.2 cm']","['Dexamethasone Sodium Phosphate Penetration', 'low (45-kHz) or high (1-MHz) frequency delivered a higher dexamethasone (Dex', 'dexamethasone sodium phosphate (Dex-P']","['Dialysate', 'measurable levels of Dex-P', 'measurable levels of Dex-P. Total dexamethasone', 'total dexamethasone (Dex-total', 'drug concentration', 'Dex-total concentration', 'ultrasound frequency ']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",40.0,0.0591625,"P  < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration ( P  = .006).","[{'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Rigby', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hagan', 'Affiliation': 'Texas State University, San Marcos.'}, {'ForeName': 'Austin R', 'Initials': 'AR', 'LastName': 'Kelcher', 'Affiliation': 'Texas State University, San Marcos.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Texas State University, San Marcos.'}]",Journal of athletic training,['10.4085/1062-6050-556-18']
121,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


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


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


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


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
122,32209449,"Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study.","BACKGROUND


Conventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localised prostate cancer. We aimed to investigate whether novel imaging using prostate-specific membrane antigen (PSMA) PET-CT might improve accuracy and affect management.
METHODS


In this multicentre, two-arm, randomised study, we recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia. Patients were randomly assigned to conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT. First-line imaging was done within 21 days following randomisation. Patients crossed over unless three or more distant metastases were identified. The primary outcome was accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up. This trial is registered with the Australian New Zealand Clinical Trials Registry, ANZCTR12617000005358.
FINDINGS


From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men were randomly assigned. 152 (50%) men were randomly assigned to conventional imaging and 150 (50%) to PSMA PET-CT. Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease. PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001). We found a lower sensitivity (38% [24-52] vs 85% [74-96]) and specificity (91% [85-97] vs 98% [95-100]) for conventional imaging compared with PSMA PET-CT. Subgroup analyses also showed the superiority of PSMA PET-CT (area under the curve of the receiver operating characteristic curve 91% vs 59% [32% absolute difference; 28-35] for patients with pelvic nodal metastases, and 95% vs 74% [22% absolute difference; 18-26] for patients with distant metastases). First-line conventional imaging conferred management change less frequently (23 [15%] men [10-22] vs 41 [28%] men [21-36]; p=0·008) and had more equivocal findings (23% [17-31] vs 7% [4-13]) than PSMA PET-CT did. Radiation exposure was 10·9 mSv (95% CI 9·8-12·0) higher for conventional imaging than for PSMA PET-CT (19·2 mSv vs 8·4 mSv; p<0·001). We found high reporter agreement for PSMA PET-CT (κ=0·87 for nodal and κ=0·88 for distant metastases). In patients who underwent second-line image, management change occurred in seven (5%) of 136 patients following conventional imaging, and in 39 (27%) of 146 following PSMA PET-CT.
INTERPRETATION


PSMA PET-CT is a suitable replacement for conventional imaging, providing superior accuracy, to the combined findings of CT and bone scanning.
FUNDING


Movember and Prostate Cancer Foundation of Australia. VIDEO ABSTRACT.",2020,PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001).,"['patients with high-risk prostate cancer before curative-intent surgery or', 'staging men with high-risk localised prostate cancer', 'Of 295 (98%) men with follow-up, 87 (30%) had pelvic nodal or distant metastatic disease', 'From March 22, 2017 to Nov 02, 2018, 339 men were assessed for eligibility and 302 men', 'recruited men with biopsy-proven prostate cancer and high-risk features at ten hospitals in Australia', '152 (50%) men']","['novel imaging using prostate-specific membrane antigen (PSMA', 'Prostate-specific membrane antigen PET-CT', 'PSMA PET-CT', 'radiotherapy (proPSMA', 'PET-CT', 'conventional imaging with CT and bone scanning or gallium-68 PSMA-11 PET-CT', 'CT and bone scan']","['accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry', 'superiority of PSMA PET-CT', 'lower sensitivity', 'specificity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1310550', 'cui_str': 'prostate-specific membrane antigen, human'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0303226', 'cui_str': 'Gallium-68'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0034925', 'cui_str': 'Reference Standards'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C1699633', 'cui_str': 'Positron Emission Tomography Computed Tomography'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",339.0,0.223657,PSMA PET-CT had a 27% (95% CI 23-31) greater accuracy than that of conventional imaging (92% [88-95] vs 65% [60-69]; p<0·0001).,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: michael.hofman@petermac.org.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Lawrentschuk', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Department of Surgery, Austin Health, Melbourne, VIC, Australia; Urological Society of Australia and New Zealand, NSW, Australia.'}, {'ForeName': 'Roslyn J', 'Initials': 'RJ', 'LastName': 'Francis', 'Affiliation': 'Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; University of Western Australia, Faculty of Health and Medical Sciences, Perth, WA, Australia; ARTnet, NSW, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Vela', 'Affiliation': 'Department of Urology, Princess Alexandra Hospital, Australian Prostate Cancer Research Centre-Queensland, Queensland University of Technology, Translational Research Institute, Brisbane, QLD, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': ""Department of Nuclear Medicine, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Rutherford', 'Affiliation': 'Department of Nuclear Medicine, Hunter New England Health, Newcastle, NSW, Australia.'}, {'ForeName': 'Jarad M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Frydenberg', 'Affiliation': 'Department of Surgery, Monash University and Cabrini Institute, Cabrini Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Ramdave', 'Initials': 'R', 'LastName': 'Shakher', 'Affiliation': 'Monash Health Imaging, Monash Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Lih-Ming', 'Initials': 'LM', 'LastName': 'Wong', 'Affiliation': ""Department of Urology and Surgery, St Vincent's Health Melbourne, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Taubman', 'Affiliation': ""Department of Medical Imaging, PET/CT and St Vincent's Private Radiology, St Vincent's Health, Melbourne, VIC, Australia.""}, {'ForeName': 'Sze', 'Initials': 'S', 'LastName': 'Ting Lee', 'Affiliation': 'Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Hsiao', 'Affiliation': 'University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Roach', 'Affiliation': 'University of Sydney, Department of Nuclear Medicine and PET, Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Nottage', 'Affiliation': 'Clinical and Research Imaging Centre, South Australian Health and Medical Research Institute, Adelaide, SA, Australia; Dr Jones and Partners Medical Imaging, Adelaide, SA, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Dickon', 'Initials': 'D', 'LastName': 'Hayne', 'Affiliation': 'UWA Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Link', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Marusic', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Anetta', 'Initials': 'A', 'LastName': 'Matera', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Iravani', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Hicks', 'Affiliation': 'Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia; Australian and New Zealand Urogenital and Prostate Cancer Trials Group, NSW, Australia.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30314-7']
123,30538299,Lifestyle interventions in Muslim patients with metabolic syndrome-a feasibility study.,"Obesity, metabolic syndrome, and type-2 diabetes mellitus are common in Muslim patients living in Germany, most of whom are of Turkish origin. Lifestyle interventions must be tailored to religion and ethnicity. We tested the body weight-reducing effect of a 30% calorie-reduced intake diet, adjusted to individual energy expenditure, eating habits, and food preferences in a Turkish-background cohort. Eighty subjects were randomized to activity advice only or to a step-count device to monitor and document physical activity before and after the 12-week intervention. Fifty-three patients completed the study. Lifestyle interventions were effective in these Muslim subjects. Body weight was reduced by 6%; activity monitoring provided a modestly increased effect to 8%. Blood glucose, HbA1c, triglycerides and cholesterol improved also substantially. Subjects receiving metformin could reduce their dosage. Our data show that Muslim Turkish patients respond to interventions if these are tailored to their needs.",2019,"Blood glucose, HbA1c, triglycerides and cholesterol improved also substantially.","['Fifty-three patients completed the study', 'Muslim patients with metabolic syndrome', 'Eighty subjects']","['Lifestyle interventions', 'metformin']","['Blood glucose, HbA1c, triglycerides and cholesterol', 'Body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026870', 'cui_str': 'Muslims'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",80.0,0.0165118,"Blood glucose, HbA1c, triglycerides and cholesterol improved also substantially.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Aktas', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mähler', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamm', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Perger', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Simon', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Westenhöfer', 'Affiliation': 'Hochschule für Angewandte Wissenschaften, Fakultät Life Sciences, Abt. Ökotrophologie, Lohbrügger Kirchstraße 65, 21033, Hamburg, Germany.'}, {'ForeName': 'Friedrich C', 'Initials': 'FC', 'LastName': 'Luft', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boschmann', 'Affiliation': 'Experimental & Clinical Research Center - a joint co-operation between Charité Universitätsmedizin Berlin and Max-Delbrück Center for Molecular Medicine, Berlin, Lindenberger Weg 80, 13125, Berlin, Germany. michael.boschmann@charite.de.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0371-z']
124,32152693,Comparisons of venous indwelling needles and intravenous infusion with steel needles in pediatric outpatient care.,"OBJECTIVE


To compare the application effects of venous indwelling needles and intravenous infusion with steel needles in pediatric outpatient care and to observe the complications of the two approaches.
METHODS


A total of 110 children who received intravenous infusions in our hospital from March 2018 to May 2018 were selected as study subjects. Children were assigned to an observation group (n = 55) or a control group (n = 55) based on a random number table, of which the children in the control group received intravenous infusion with the steel needles while the children in the observation group received intravenous infusion with indwelling needles. Their mental states were rationally evaluated by the state-trait anxiety inventory (STAI) and modified Yale preoperative anxiety score (MYPAS) in the two groups. At the same time, the total number of punctures in 3 days of infusion, complications and the parents' satisfaction with nursing service were compared between the two groups.
RESULTS


The difference in STAI and MYPAS scores was statistically significant between the two groups (P < 0.05). The difference in the total number of punctures on the first day was not statistically significant (P > 0.05) between the two groups, but the difference in the total number of punctures on the second day and the third day was statistically significant (P < 0.05). Besides this, the incidence of complications in the observation group was less than that in the control group, and the nursing satisfaction in the observation group was higher than that in the control group (P < 0.05).
CONCLUSION


The children's psychological impacts are relatively small when comparing the venous indwelling needle with the steel needle. Moreover, venous indwelling needles avoid repeated punctures; therefore, the parents' satisfaction in nursing is improved, and it is worth popularizing.",2020,"The difference in the total number of punctures on the first day was not statistically significant (P > 0.05) between the two groups, but the difference in the total number of punctures on the second day and the third day was statistically significant (P < 0.05).","['110\xa0children who received intravenous infusions in our hospital from March 2018 to May 2018 were selected as study subjects', 'pediatric outpatient care']","['venous indwelling needles and intravenous infusion with steel needles', 'intravenous infusion with the steel needles while the children in the observation group received intravenous infusion with indwelling needles']","['incidence of complications', 'state-trait anxiety inventory (STAI) and modified Yale preoperative anxiety score (MYPAS', 'nursing satisfaction', 'total number of punctures', 'STAI and MYPAS scores']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0038239', 'cui_str': 'Steel'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",,0.0243725,"The difference in the total number of punctures on the first day was not statistically significant (P > 0.05) between the two groups, but the difference in the total number of punctures on the second day and the third day was statistically significant (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': ""Department of Outpatient Treatment Centre, Children's Hospital Capital Institute of Pediatrics, 100020, Beijing, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nursing, Children's Hospital Capital Institute of Pediatrics, No. 2 of Yabao Street, 100020, Beijing, Chaoyang District, China. nursyang@163.com.""}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01617-w']
125,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES


Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested.
PARTICIPANTS/METHODS


Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age.
RESULTS


RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
CONCLUSIONS


Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1']
126,31928568,Predictors of treatment outcomes and adherence in internet-based cognitive behavioral therapy for social anxiety in China.,"BACKGROUND


Although internet-based cognitive behaviour therapy (ICBT) is an effective treatment for social anxiety disorder (SAD), a substantial proportion of patients do not achieve clinically significant improvement. More research is needed to identify which factors predict treatment adherence and outcomes.
AIMS


The aims of this study were to (1) identify demographic and clinical factors associated with treatment adherence and outcomes in ICBT for social anxiety in China, and (2) explore whether low-intensity therapist support results in improved treatment adherence or outcomes.
METHOD


Participants were assigned to either therapist-guided (N = 183) or self-guided ICBT (N = 72). Level of social anxiety was measured at both pre- and post-treatment. Treatment adherence and outcomes were analysed using a two-step linear and logistic regression approach. Clinical and demographic characteristics were examined.
RESULTS


No significant group differences were found for treatment adherence or outcomes between the therapist-guided and self-guided conditions. Participants diagnosed with SAD were significantly less likely to drop out (OR 0.531, p = .03) compared with subclinical participants with social anxiety symptoms. Older participants (B = 0.17, SE = 0.04, p = .008) and participants with a diagnosis of SAD (B = 0.16, SE = 0.44, p = .01) tended to complete more modules. Participants who completed more modules (B = 0.24, SE = 0.03, p = .01) and participants who identified as female (B = -0.20, SE = 0.18, p = .04) reported greater reductions in SAD symptoms.
CONCLUSIONS


Understanding of factors related to adherence and outcome is necessary to prevent drop-out and optimize outcome.",2020,"Participants diagnosed with SAD were significantly less likely to drop out (OR 0.531, p = .03) compared with subclinical participants with social anxiety symptoms.","['Participants', 'social anxiety in China']","['therapist-guided (N = 183) or self-guided ICBT', 'internet-based cognitive behavioral therapy', 'internet-based cognitive behaviour therapy (ICBT']","['SAD symptoms', 'Level of social anxiety', 'SAD', 'social anxiety symptoms', 'diagnosis of SAD']","[{'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.0475176,"Participants diagnosed with SAD were significantly less likely to drop out (OR 0.531, p = .03) compared with subclinical participants with social anxiety symptoms.","[{'ForeName': 'Huijing', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing100871, People's Republic of China.""}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Rodriguez', 'Affiliation': 'Boston Child Study Center, Los Angeles and Pitzer College, Claremont, CA91711, USA.'}, {'ForeName': 'Mingyi', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': ""School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing100871, People's Republic of China.""}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kishimoto', 'Affiliation': ""School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing100871, People's Republic of China.""}, {'ForeName': 'Muyu', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': ""School of Psychological and Cognitive Sciences and Beijing Key Laboratory of Behavior and Mental Health, Peking University, Beijing100871, People's Republic of China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern3012, Switzerland.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000730']
127,32187767,"""Take an HIV Test Kit Home"": A Pilot Randomized Controlled Trial Among HIV High-risk Urban ED Patients.",,2020,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"['people who inject drugs, men who have sex with men (MSM), and heterosexuals at increased risk, should be screened for HIV at least once annually and sexually active MSM from testing every 3-6 months', 'HIV High-Risk Urban ED Patients']",[],[],"[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.214878,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"[{'ForeName': 'Angie S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anuj V', 'Initials': 'AV', 'LastName': 'Patel', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jett-Goheen', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Abrams', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'and the, Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13968']
128,31915060,Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students.,"BACKGROUND


School-based comprehensive sexual health education can improve adolescent health outcomes, and web-based programs are a promising approach to overcoming challenges associated with teacher-led formats by ensuring that students receive content that is consistent, unbiased, and medically accurate. However, many adolescents do not receive high-quality sexual health education and turn to the media for information about sex and relationships. Consumption of sexual media messages is related to early and risky sexual behaviors. Media literacy education (MLE) is a proven approach to adolescent sexual health promotion, yet there are no rigorously evaluated web-based MLE programs to promote sexual and relationship health among high school students.
METHODS


This study will test the efficacy, in a randomized controlled trial, of Media Aware, a web-based comprehensive sexual health promotion program for high school students that uses an MLE approach. Participants will be students in 9th and 10th grade health classes in participating schools. Randomization will take place at the school level, and data collection will take place at three time points (i.e., pretest, posttest, and 3 months follow-up). Students in the intervention classrooms will receive Media Aware between pretest and posttest, and students in the delayed-intervention classrooms will receive Media Aware after study completion (i.e., after 3 months follow-up data collection). Students in the delayed-intervention classes will receive their standard health education programming, and teachers in the delayed-intervention classes will be asked to refrain from teaching sexual health or MLE during the study timeframe. The primary outcome variables are intentions, willingness, and behaviors related to sexual health and sexual activity.
DISCUSSION


There are currently no evidence-based comprehensive sexual health programs for high school students that are web-based and use an MLE approach. Media Aware has the potential to be an engaging, less expensive, and effective sexual and relationship health program for high school students. Media Aware is unique in two important ways: (1) the web-based format reduces many of the challenges to fidelity of implementation associated with teacher-led sexual health education; and (2) the MLE approach addresses a commonly ignored influence on adolescent sexual and relationship health, namely, media.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04035694. Registered on 29 July 2019. Contact for Scientific Queries: Tracy Scull, PhD (Principal Investigator); innovation Research & Training at 5316 Highgate Drive, Suite 121, Durham, North Carolina, USA 27713; tscull@irtinc.us.",2020,"Media Aware has the potential to be an engaging, less expensive, and effective sexual and relationship health program for high school students.","['high school students', 'Participants will be students in 9th and 10th grade health classes in participating schools']","['Media literacy education (MLE', 'web-based comprehensive sexual health and media literacy education program']","['intentions, willingness, and behaviors related to sexual health and sexual activity']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",,0.0437699,"Media Aware has the potential to be an engaging, less expensive, and effective sexual and relationship health program for high school students.","[{'ForeName': 'Tracy M', 'Initials': 'TM', 'LastName': 'Scull', 'Affiliation': 'Innovation Research & Training, 5316 Highgate Drive, Suite 121, Durham, NC, 27713, USA. tscull@irtinc.us.'}, {'ForeName': 'Christina V', 'Initials': 'CV', 'LastName': 'Malik', 'Affiliation': 'Innovation Research & Training, 5316 Highgate Drive, Suite 121, Durham, NC, 27713, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Innovation Research & Training, 5316 Highgate Drive, Suite 121, Durham, NC, 27713, USA.'}, {'ForeName': 'Elyse M', 'Initials': 'EM', 'LastName': 'Keefe', 'Affiliation': 'Innovation Research & Training, 5316 Highgate Drive, Suite 121, Durham, NC, 27713, USA.'}]",Trials,['10.1186/s13063-019-3992-1']
129,32293446,The effects of enhanced primary healthcare interventions on primary care providers' job satisfaction.,"BACKGROUND


In response to the rising burden of cardiovascular risk factors, the Malaysian government has implemented Enhanced Primary Healthcare (EnPHC) interventions in July 2017 at public clinic level to improve management and clinical outcomes of type 2 diabetes and hypertensive patients. Healthcare providers (HCPs) play crucial roles in healthcare service delivery and health system reform can influence HCPs' job satisfaction. However, studies evaluating HCPs' job satisfaction following primary care transformation remain scarce in low- and middle-income countries. This study aims to evaluate the effects of EnPHC interventions on HCPs' job satisfaction.
METHODS


This is a quasi-experimental study conducted in 20 intervention and 20 matched control clinics. We surveyed all HCPs who were directly involved in patient management. A self-administered questionnaire which included six questions on job satisfaction were assessed on a scale of 1-4 at baseline (April and May 2017) and post-intervention phase (March and April 2019). Unadjusted intervention effect was calculated based on absolute differences in mean scores between intervention and control groups after implementation. Difference-in-differences analysis was used in the multivariable linear regression model and adjusted for providers and clinics characteristics to detect changes in job satisfaction following EnPHC interventions. A negative estimate indicates relative decrease in job satisfaction in the intervention group compared with control group.
RESULTS


A total of 1042 and 1215 HCPs responded at baseline and post-intervention respectively. At post-intervention, the intervention group reported higher level of stress with adjusted differences of - 0.139 (95% CI -0.266,-0.012; p = 0.032). Nurses, being the largest workforce in public clinics were the only group experiencing dissatisfaction at post-intervention. In subgroup analysis, nurses from intervention group experienced increase in work stress following EnPHC interventions with adjusted differences of - 0.223 (95% CI -0.419,-0.026; p = 0.026). Additionally, the same group were less likely to perceive their profession as well-respected at post-intervention (β = - 0.175; 95% CI -0.331,-0.019; p = 0.027).
CONCLUSIONS


Our findings suggest that EnPHC interventions had resulted in some untoward effect on HCPs' job satisfaction. Job dissatisfaction can have detrimental effects on the organisation and healthcare system. Therefore, provider experience and well-being should be considered before introducing healthcare delivery reforms to avoid overburdening of HCPs.",2020,"At post-intervention, the intervention group reported higher level of stress with adjusted differences of - 0.139 (95% CI -0.266,-0.012; p = 0.032).","[""primary care providers' job satisfaction"", '20 intervention and 20 matched control clinics', 'type 2 diabetes and hypertensive patients']","['enhanced primary healthcare interventions', 'EnPHC interventions']","['job satisfaction', 'level of stress', ""HCPs' job satisfaction"", 'work stress']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}]",,0.0620719,"At post-intervention, the intervention group reported higher level of stress with adjusted differences of - 0.139 (95% CI -0.266,-0.012; p = 0.032).","[{'ForeName': 'Wen Jun', 'Initials': 'WJ', 'LastName': 'Wong', 'Affiliation': 'Centre for Clinical Outcomes Research, Institute for Clinical Research, National Institutes of Health (NIH), Ministry of Health Malaysia, No. 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170, Shah Alam, Selangor, Malaysia. wwjun@crc.moh.gov.my.'}, {'ForeName': 'Aisyah', 'Initials': 'A', 'LastName': 'Mohd Norzi', 'Affiliation': 'Centre for Clinical Outcomes Research, Institute for Clinical Research, National Institutes of Health (NIH), Ministry of Health Malaysia, No. 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Swee Hung', 'Initials': 'SH', 'LastName': 'Ang', 'Affiliation': 'Centre for Clinical Outcomes Research, Institute for Clinical Research, National Institutes of Health (NIH), Ministry of Health Malaysia, No. 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Chee Lee', 'Initials': 'CL', 'LastName': 'Chan', 'Affiliation': 'Centre for Clinical Outcomes Research, Institute for Clinical Research, National Institutes of Health (NIH), Ministry of Health Malaysia, No. 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Faeiz Syezri Adzmin', 'Initials': 'FSA', 'LastName': 'Jaafar', 'Affiliation': 'Institute for Health Management, National Institutes of Health (NIH), Ministry of Health Malaysia, No. 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170, Shah Alam, Selangor, Malaysia.'}, {'ForeName': 'Sheamini', 'Initials': 'S', 'LastName': 'Sivasampu', 'Affiliation': 'Centre for Clinical Outcomes Research, Institute for Clinical Research, National Institutes of Health (NIH), Ministry of Health Malaysia, No. 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170, Shah Alam, Selangor, Malaysia.'}]",BMC health services research,['10.1186/s12913-020-05183-9']
130,32101272,"Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial.","Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT03212196.",2020,"The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
","['Patients', 'With High-Risk Pancreatic Anastomosis', 'Participants\n\n\nA single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score', '604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n\u2009=\u200936; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n\u2009=\u200936; 26 men and 10 women; median age, 63 years [interquartile range, 35-79', 'patients at high risk of POPF after pancreaticoduodenectomy']","['Externalized Stent vs Pancreaticogastrostomy With Externalized Stent', 'PJ or PG, both with externalized transanastomotic stent and octreotide omission', 'PG or PJ', 'pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent', 'externalized stent and octreotide omission']","['delayed gastric emptying', 'Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden', 'incidence of Clavien-Dindo grade 3 or higher morbidity', 'mean (SD) average complication burden', 'rates of postpancreatectomy hemorrhage', 'rates of POPF', 'POPF', 'incidence of POPF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis (procedure)'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0030303', 'cui_str': 'Pancreatojejunostomy'}]","[{'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",604.0,0.257267,"The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Andrianello', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Malleo', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Masini', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Balduzzi', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Esposito', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Landoni', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Casetti', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tuveri', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}]",JAMA surgery,['10.1001/jamasurg.2019.6035']
131,32319154,Cost-effectiveness of a specialist smoking cessation package compared with standard smoking cessation services for people with severe mental illness in England: a trial-based economic evaluation from the SCIMITAR+ study.,"AIMS


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


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


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


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


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


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


A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.",2020,A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.,"['Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n=526', 'Sixteen primary care and 21 secondary care mental health sites in England PARTICIPANTS', 'people with severe mental illness', 'people with severe mental illness in England', 'participants who were randomised, 261 were in UC group and 265 were in BSC group']","['BSC) package', 'mental health smoking cessation practitioner versus usual care (UC', 'bespoke smoking cessation package', 'AND COMPARATOR\n\n\nA bespoke smoking cessation', 'standard smoking cessation services', 'specialist smoking cessation package']","['BSC intervention cost', 'mean total cost', 'cost-effectiveness', 'Incremental costs and incremental QLAYs', 'Cost-effectiveness', 'Total costs, including smoking cessation, healthcare and social services costs, and quality-adjusted life years (QALYs), derived from EQ-5D-5L', 'Costs of UC, healthcare and social services, and EQ-5D-5L']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.132121,A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.,"[{'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heron', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Crosland', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Mental Health and Addictions Research Group (MHARG), Department of Health Sciences, University of York, York, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Addiction (Abingdon, England)",['10.1111/add.15086']
132,32318809,A phase I study of the effect of repeated oral doses of pantoprazole on the pharmacokinetics of a single dose of fedratinib in healthy male subjects.,"PURPOSE


Fedratinib, an oral, selective Janus kinase 2 inhibitor with activity against both wild-type and mutant Janus kinase 2, has pH-dependent solubility, with free solubility at pH 1. Concomitant administration of drugs that reduce gastric acid secretion, such as pantoprazole, may decrease the absorption of fedratinib and affect patient outcomes. The aim of this study was to evaluate the impact of 7-day repeated 40-mg doses of pantoprazole on the pharmacokinetic (PK) properties of a single 500-mg dose of fedratinib in healthy male subjects.
METHODS


In this phase I, single-center, open-label, two-period, two-treatment, fixed-sequence crossover study, healthy male subjects were administered a single dose of fedratinib 500 mg on day 1 in Period 1, followed by pantoprazole 40 mg daily for 7 days (day 1 to day 7) and a single dose of fedratinib 500 mg on day 7 in Period 2. After the discontinuation of nine subjects due to vomiting, the protocol was amended to provide ondansetron as antiemetic prophylaxis to an additional ten enrolled subjects.
RESULTS


Twenty-six subjects were included. Repeated doses of pantoprazole 40 mg resulted in clinically insignificant increases in fedratinib exposure. Maximum plasma concentration increased by 1.09-fold and area under the plasma concentration-time curve from time 0 to infinity increased by 1.15-fold. All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
CONCLUSION


Coadministration with pantoprazole did not have clinically meaningful effects on fedratinib PK. No new or unexpected safety signals were observed with fedratinib.",2020,"All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
","['healthy male subjects', 'Twenty-six subjects were included']","['pantoprazole', 'ondansetron', 'fedratinib 500\xa0mg on day 1 in Period 1, followed by pantoprazole']","['Maximum plasma concentration', 'gastric acid secretion', 'fedratinib exposure']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232552', 'cui_str': 'Gastric acid secretion'}, {'cui': 'C3886623', 'cui_str': 'Fedratinib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",26.0,0.144717,"All treatment-emergent adverse events were mild or moderate, except for one instance of neutropenia, which was considered unrelated to study intervention.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ogasawara', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences/Vince and Associates, Overland Park, KS, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Krishna', 'Affiliation': 'Bristol Myers Squibb, 556 Morris Ave, Summit, NJ, 07901, USA. gopal.krishna@bms.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04074-4']
133,31823141,Effect of short-term methotrexate discontinuation on rheumatoid arthritis disease activity: post-hoc analysis of two randomized trials.,"To investigate the effects of short-term discontinuation of methotrexate (MTX) on disease activity in patients with rheumatoid arthritis (RA) taking a stable dose of MTX. A post-hoc analysis of two randomized controlled trials was used to investigate the effects of temporary MTX discontinuation (for 2 weeks or 4 weeks) on responses to seasonal influenza vaccination. The impact of MTX discontinuation on the RA disease activity score (DAS28) and RA flare rate during discontinuation and after reintroduction was examined. The DAS28 increased during the 4-week MTX discontinuation period, before returning to baseline after reintroduction. The overall flare-free survival period did not differ between the groups (log rank p = 0.142). However, during the 4-week MTX discontinuation period, more patients in the MTX-hold group than in the MTX-continue group experienced a flare (20.5% vs. 7.4%, respectively; p = 0.058). After resumption of MTX, the flare rate did not differ between groups. The flare rates in the MTX-continue group and the 2-week and 4-week MTX-hold groups were 5.8%, 10.8% and 20.5%, respectively (p < 0.01). The change in the DAS28 from baseline did not differ significantly between the MTX-continue and the 2-week MTX-discontinue groups. However, there was a significant difference between the 4-week MTX-hold group and the MTX-continue group (p = 0.005). Short-term discontinuation of MTX for up to 2 weeks is safe, whereas discontinuation for 4 weeks is associated with a transient increase in disease flares and activity in RA patients taking a stable MTX dose.Key Points• Methotrexate discontinuation for 2 weeks is safe.• Methotrexate discontinuation for 4 weeks transiently increases flare risk and disease activity.• Disease flare risk and disease activity return to baseline after restarting methotrexate treatment.",2020,The overall flare-free survival period did not differ between the groups (log rank p = 0.142).,"['rheumatoid arthritis disease activity', 'patients with rheumatoid arthritis (RA']","['methotrexate (MTX', 'MTX', 'short-term methotrexate discontinuation', 'temporary MTX discontinuation']","['DAS28', 'disease activity', 'RA disease activity score (DAS28) and RA flare rate', 'flare rates', 'disease flares and activity', 'flare risk and disease activity.•', 'Disease flare risk and disease activity return', 'overall flare-free survival period', 'flare rate']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0245859,The overall flare-free survival period did not differ between the groups (log rank p = 0.142).,"[{'ForeName': 'Jin Kyun', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Winthrop', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Yeong Wook', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Eun Bong', 'Initials': 'EB', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. leb7616@snu.ac.kr.'}]",Clinical rheumatology,['10.1007/s10067-019-04857-y']
134,32054896,"Instability Resistance Training improves Working Memory, Processing Speed and Response Inhibition in Healthy Older Adults: A Double-Blinded Randomised Controlled Trial.","Aging is associated with declines in physical and cognitive performance. While there is no doubt about beneficial effects of physical exercise on proxies of strength and balance, the overall evidence for positive effects of resistance and balance training on executive functions is rather inconsistent. Whether the simultaneous exercising of strength and balance, i.e., instability resistance training, promotes executive functions in older adults is unknown. In the present trial, we tested the effects of unstable vs. stable resistance training on executive functions. Sixty-eight healthy older adults aged 65-79 years were randomly assigned to either an instability free-weight resistance training or one of two stable machine-based resistance training programs. Each group exercised twice a week on non-consecutive days for 10 weeks. Four tests to evaluate specific domains of executive functions were administered prior and following training: working memory, processing speed, response inhibition and set-shifting. The instability resistance training group improved working memory, processing speed and response inhibition from pre to post-test. In contrast, we found no improvements in executive functions for both stable resistance training groups. Our results demonstrate that 10 weeks of instability resistance training suffice to improve executive functions in older adults.",2020,Sixty-eight healthy older adults aged 65-79 years were randomly assigned to either an instability free-weight resistance training or one of two stable machine-based resistance training programs.,"['Healthy Older Adults', 'older adults', 'Sixty-eight healthy older adults aged 65-79 years']","['Instability Resistance Training', 'physical exercise', 'unstable vs. stable resistance training', 'instability free-weight resistance training or one of two stable machine-based resistance training programs']","['physical and cognitive performance', 'executive functions', 'working memory, processing speed and response inhibition', 'Working Memory, Processing Speed and Response Inhibition']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",68.0,0.0361629,Sixty-eight healthy older adults aged 65-79 years were randomly assigned to either an instability free-weight resistance training or one of two stable machine-based resistance training programs.,"[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'University of Kassel, Institute of Sports and Sport Science, Department of Training and Movement Science, Kassel, 34121, Germany. nils.eckardt@uol.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Braun', 'Affiliation': 'University of Kassel, Institute of Sports and Sport Science, Department of Training and Movement Science, Kassel, 34121, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Kibele', 'Affiliation': 'University of Kassel, Institute of Sports and Sport Science, Department of Training and Movement Science, Kassel, 34121, Germany.'}]",Scientific reports,['10.1038/s41598-020-59105-0']
135,31806076,"Concordance between clinician, supervisor and observer ratings of therapeutic competence in CBT and treatment as usual: does clinician competence or supervisor session observation improve agreement?","BACKGROUND


Lowering the cost of assessing clinicians' competence could promote the scalability of evidence-based treatments such as cognitive behavioral therapy (CBT).
AIMS


This study examined the concordance between clinicians', supervisors' and independent observers' session-specific ratings of clinician competence in school-based CBT and treatment as usual (TAU). It also investigated the association between clinician competence and supervisory session observation and rater agreement.
METHOD


Fifty-nine school-based clinicians (90% female, 73% Caucasian) were randomly assigned to implement TAU or modular CBT for youth anxiety. Clinicians rated their confidence after each therapy session (n = 1898), and supervisors rated clinicians' competence after each supervision session (n = 613). Independent observers rated clinicians' competence from audio recordings (n = 395).
RESULTS


Patterns of rater discrepancies differed between the TAU and CBT groups. Correlations with independent raters were low across groups. Clinician competence and session observation were associated with higher agreement among TAU, but not CBT, supervisors and clinicians.
CONCLUSIONS


These results support the gold standard practice of obtaining independent ratings of adherence and competence in implementation contexts. Further development of measures and/or rater training methods for clinicians and supervisors is needed.",2020,"Clinician competence and session observation were associated with higher agreement among TAU, but not CBT, supervisors and clinicians.
","['Fifty-nine school-based clinicians (90% female, 73% Caucasian']",['TAU or modular CBT'],[],"[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],1898.0,0.0251435,"Clinician competence and session observation were associated with higher agreement among TAU, but not CBT, supervisors and clinicians.
","[{'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Caron', 'Affiliation': 'Department of Psychological Science, Fitchburg State University, Fitchburg, MA 01420, USA.'}, {'ForeName': 'Michela A', 'Initials': 'MA', 'LastName': 'Muggeo', 'Affiliation': 'Clarus Health Alliance, Norwich, CT 06360, USA.'}, {'ForeName': 'Heather R', 'Initials': 'HR', 'LastName': 'Souer', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, West Hartford, CT 06119, USA.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Pella', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, West Hartford, CT 06119, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, West Hartford, CT 06119, USA.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000699']
136,32032307,Neonatal Outcomes Following Culture-negative Late-onset Sepsis Among Preterm Infants.,"BACKGROUND


Culture-negative late-onset sepsis (LOS) is commonly diagnosed in neonatal intensive care units, while the outcomes of neonatal culture-negative LOS are not reported for large cohorts. This study aimed to examine the incidence and neonatal outcomes for culture-negative LOS in a contemporary multicenter cohort of preterm infants.
METHODS


We performed a retrospective analysis of data from a cluster-randomized controlled study. Infants <34 weeks of gestation and admitted to 25 neonatal intensive care units between May 1, 2015, and April 30, 2018, were included. Culture-negative LOS was diagnosed if infants had abnormal manifestations and laboratory tests but negative blood cultures. The primary outcome was a composite of mortality or morbidities including periventricular leukomalacia (PVL), retinopathy of prematurity (ROP) ≥ stage 3 or bronchopulmonary dysplasia (BPD).
RESULTS


Of 22,346 eligible infants, 1505 (6.7%) infants had culture-negative and 761 (3.4%) infants had culture-positive LOS. Compared with infants without LOS, infants with culture-negative LOS had higher rates of composite outcome (24.1% vs. 9.6%), death (3.8% vs. 1.8%), PVL (4.8% vs. 2.2%), severe ROP (3.3% vs. 1.1%) and BPD (18.1% vs. 7.0%). After adjustment, culture-negative LOS was independently associated with increased risk of composite outcome {adjusted odds ratio [aOR]: 1.8 [95% confidence interval (CI): 1.5-2.1]}, PVL [aOR: 2.0 (95% CI: 1.4-2.8)] and BPD [aOR: 1.8 (95% CI: 1.5-2.2)] relative to the absence of LOS.
CONCLUSION


Culture-negative LOS was frequently diagnosed in preterm infants and was associated with increased risks of adverse outcomes. There is an emerging need for more precise diagnosis and treatment strategies for culture-negative LOS.",2020,"After adjustment, culture-negative LOS was independently associated with increased risk of composite outcome {adjusted odds ratio [aOR]: 1.8 [95% confidence interval (CI): 1.5-2.1]}, PVL [aOR: 2.0 (95% CI: 1.4-2.8)] and BPD [aOR: 1.8 (95% CI: 1.5-2.2)] relative to the absence of LOS.
","['Preterm Infants', '22,346 eligible infants, 1505 (6.7%) infants had culture-negative and 761 (3.4%) infants had culture-positive LOS', 'Infants <34 weeks of gestation and admitted to 25 neonatal intensive care units between May 1, 2015, and April 30, 2018, were included', 'preterm infants']","['culture-negative LOS', 'Culture-negative late-onset sepsis (LOS']","['risks of adverse outcomes', 'PVL', 'BPD', 'composite of mortality or morbidities including periventricular leukomalacia (PVL), retinopathy of prematurity (ROP) ≥ stage 3 or bronchopulmonary dysplasia (BPD', 'severe ROP', 'rates of composite outcome', 'death']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0159125', 'cui_str': 'Culture positive'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023529', 'cui_str': 'Encephalomalacia, Periventricular'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",22346.0,0.469954,"After adjustment, culture-negative LOS was independently associated with increased risk of composite outcome {adjusted odds ratio [aOR]: 1.8 [95% confidence interval (CI): 1.5-2.1]}, PVL [aOR: 2.0 (95% CI: 1.4-2.8)] and BPD [aOR: 1.8 (95% CI: 1.5-2.2)] relative to the absence of LOS.
","[{'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""From the Department of Neonatology, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Zuming', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Neonatology, Suzhou Municipal Hospital, Jiangsu, China.'}, {'ForeName': 'Ruobing', 'Initials': 'R', 'LastName': 'Shan', 'Affiliation': ""Department of Neonatology, Qingdao Women and Children's Hospital, Shandong, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Clinical Epidemiology, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Department of Clinical Epidemiology, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Key Laboratory of Neonatal Diseases, Ministry of Health, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Prakesh S', 'Initials': 'PS', 'LastName': 'Shah', 'Affiliation': 'Maternal-Infant Care Research Centre and Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Shoo K', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Maternal-Infant Care Research Centre and Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""From the Department of Neonatology, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002558']
137,32319204,Successful introduction of milk after a negative double-blind placebo-controlled food challenge test is independent of the total dose and milk product used during the challenge test.,"BACKGROUND


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


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


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


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


Successful introduction of milk after a negative challenge test is independent of the total dose of milk protein, and milk product used during the challenge test.",2020,"There were no significant differences between the low and high dose of milk protein in patient characteristics, percentage of patients lost to follow-up (15% vs 20%), in whom introduction had not yet been performed (4% vs 3.1%), reappearance of symptoms (18% vs 17%), and successful introduction (88.0% and 83.4%).",['485 patients challenged with a low or high dose of milk protein'],"['milk protein and different milk products', 'Pasteurized milk and milk protein powder', 'placebo']","['successful introduction rate', 'reappearance of symptoms', 'successful introduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}]","[{'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",485.0,0.0428838,"There were no significant differences between the low and high dose of milk protein in patient characteristics, percentage of patients lost to follow-up (15% vs 20%), in whom introduction had not yet been performed (4% vs 3.1%), reappearance of symptoms (18% vs 17%), and successful introduction (88.0% and 83.4%).","[{'ForeName': 'Celine A', 'Initials': 'CA', 'LastName': 'van de Ven', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Herpertz', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Lidy', 'Initials': 'L', 'LastName': 'van Lente', 'Affiliation': 'Department of Clinical Epidemiology, Martini Academy, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Gerbrich N', 'Initials': 'GN', 'LastName': 'van der Meulen', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Arvid W A', 'Initials': 'AWA', 'LastName': 'Kamps', 'Affiliation': 'Paediatric Allergy Centre, Department of Paediatrics, Martini Hospital, Groningen, The Netherlands.'}]","Immunity, inflammation and disease",['10.1002/iid3.305']
138,32238091,"The efficacy and safety of low-frequency rotating static magnetic field therapy combined with chemotherapy on advanced lung cancer patients: a randomized, double-blinded, controlled clinical trial.","Purpose:  To evaluate the efficacy and safety of magnetic field (MF) therapy by a randomized, double-blinded, controlled clinical trial. Materials and methods:  From February 2016 to August 2019, patients with advanced lung cancer who conformed to inclusion criteria were enrolled in this study. Patients were assigned into MF therapy group (MF group, receiving both MF therapy and chemotherapy) and control group (CON group, receiving sham MF therapy and chemotherapy) randomly. The treatment course was 21 days and 2 hours per day. Changes of life quality assessment scales, objective response rate (ORR) and disease control rate (DCR) were analyzed as primary end points. The secondary end points were progression-free survival (PFS), change of blood cytokine concentrations and safety. This study has been registered on Clinicaltrials.gov (ID: NCT02701231). Results:  77 patients were enrolled and 60 finished the study. Comparing to CON group, more patients in MF group (66.7% vs 25.9%) were experiencing life quality improvement on day 21. Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma. However, the two groups were having similar ORR, DCR and PFS after treatment. Moreover, MF treatment did not increase adverse events in MF group. Conclusions:  MF therapy could improve life quality and modulate blood cytokine concentration in advanced lung cancer patients. Hence, it might be applied as an adjuvant therapy along with chemotherapy.",2020,"Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma.","['advanced lung cancer patients', '77 patients were enrolled and 60 finished the study', 'Advanced Lung Cancer Patients', 'February 2016 to August 2019, patients with advanced lung cancer who conformed to inclusion criteria were enrolled in this study']","['MF therapy', 'MF', 'MF therapy group (MF group, receiving both MF therapy and chemotherapy) and control group (CON group, receiving sham MF therapy and chemotherapy', 'Low-frequency', 'CON', 'magnetic field (MF) therapy', 'Rotating Static Magnetic Field Therapy Combined with Chemotherapy']","['efficacy and safety', 'experiencing life quality improvement', 'life quality and modulate blood cytokine concentration', 'Changes of life quality assessment scales, objective response rate (ORR) and disease control rate (DCR', 'progression-free survival (PFS), change of blood cytokine concentrations and safety', 'concentrations of IP-10 and GM-CSF', 'adverse events']","[{'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",77.0,0.151738,"Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma.","[{'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Yanran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Neurology, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}, {'ForeName': 'Liangan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory Diseases, Chinese People's Liberation Army General Hospital, Beijing, China.""}]",International journal of radiation biology,['10.1080/09553002.2020.1748737']
139,32320131,International Consultation on Incontinence Questionnaire-Satisfaction: psychometric testing of a new patient-reported outcome measure for the evaluation of satisfaction after urological surgery.,"OBJECTIVES


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


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


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


The results support the validity and reliability of a scored six-item domain for evaluating satisfaction with surgical outcomes, together with a standalone scored overall satisfaction item. The further unscored seven standalone items are anticipated to be used as the basis for adaptation and further validation of the ICIQ-S in different patient populations.",2020,"As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
","['new patient', 'A total of 410 men were included in the trial']",[],['quality of life'],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",410.0,0.0449834,"As hypothesised, post-surgery dICIQ-S scores were correlated with reduced symptoms and improved quality of life as measured by the concurrent PROMs.
","[{'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Uren', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dharmesh', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': 'Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}]",BJU international,['10.1111/bju.15091']
140,31972609,Application of Behavioral Economics Principles Improves Participation in Mailed Outreach for Colorectal Cancer Screening.,"INTRODUCTION


Colorectal cancer (CRC) is a major cause of cancer-related morbidity and mortality in the United States. Although various interventions have improved screening rates, they often require abundant resources and can be difficult to implement. Social psychology and behavioral economics principles offer an opportunity for low-cost and easy-to-implement strategies but are less common in clinical settings.
METHODS


We randomized 2,000 patients aged 50-75 years eligible for CRC screening to one of the 2 mailed interventions: a previously used text-based letter describing and offering fecal immunochemical testing (FIT) and colonoscopy (usual care arm); or a letter leveraging social psychology and behavioral economics principles (e.g., implied scarcity and choice architecture), minimal text, and multiple images to offer FIT and colonoscopy (intervention arm). We compared total screening uptake, FIT uptake, and colonoscopy uptake at 1-month intervals in each group.
RESULTS


There were 1,882 patients included in the final analysis. The mean age was 69.3 years, and baseline characteristics in the 2 groups were similar. Screening completion at 26 weeks was 19.5% in the usual care arm (16.3% FIT vs 3.2% colonoscopy, P < 0.01) and 24.1% in the intervention arm (22.1% FIT vs 2.0% colonoscopy, P < 0.01) (P = 0.02).
DISCUSSION


Among primary care patients aged 50-75 years in an academic setting, mailed CRC outreach employing social psychology and behavioral economics principles led to a higher participation in CRC screening than usual care mailed outreach.
TRANSLATIONAL IMPACT


Mailed interventions to increase CRC screening should incorporate social psychology and behavioral economics principles to improve participation.",2020,"Screening completion at 26 weeks was 19.5% in the usual care arm (16.3% FIT vs 3.2% colonoscopy, P < 0.01) and 24.1% in the intervention arm (22.1% FIT vs 2.0% colonoscopy, P < 0.01)","['Mailed Outreach for Colorectal Cancer Screening', '2,000 patients aged 50-75 years eligible for CRC screening to one of the 2 mailed interventions: a previously', 'primary care patients aged 50-75 years in an academic setting, mailed CRC outreach employing social psychology and behavioral economics principles led to a higher participation in CRC screening than usual care mailed outreach', '1,882 patients included in the final analysis']","['used text-based letter describing and offering fecal immunochemical testing (FIT) and colonoscopy (usual care arm); or a letter leveraging social psychology and behavioral economics principles (e.g., implied scarcity and choice architecture), minimal text, and multiple images to offer FIT and colonoscopy (intervention arm']","['total screening uptake, FIT uptake, and colonoscopy uptake']","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0033919', 'cui_str': 'Psychology, Social'}, {'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033919', 'cui_str': 'Psychology, Social'}, {'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",2000.0,0.021882,"Screening completion at 26 weeks was 19.5% in the usual care arm (16.3% FIT vs 3.2% colonoscopy, P < 0.01) and 24.1% in the intervention arm (22.1% FIT vs 2.0% colonoscopy, P < 0.01)","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Bakr', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Afsar-Manesh', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Raja', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dermenchyan', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Goldstein', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Suzanne B', 'Initials': 'SB', 'LastName': 'Shu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Folasade P', 'Initials': 'FP', 'LastName': 'May', 'Affiliation': 'Tamar and Vatche Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000115']
141,32100452,Sequential boost of intensity-modulated radiotherapy with chemotherapy for inoperable esophageal squamous cell carcinoma: A prospective phase II study.,"PURPOSE


This prospective phase II study aimed to determine the efficacy and tolerability of sequential boost of intensity-modulated radiation therapy (IMRT) with chemotherapy for patients with inoperable esophageal squamous cell carcinoma (ESCC).
METHODS


Patients with histologically or cytologically proven inoperable ESCC were enrolled in this study (ChiCTR-OIC-17010485). A larger target volume for subclinical lesion was irradiated with 50 Gy, and then, a smaller target volume only including gross tumor was boosted to 66 Gy. The fraction dose was 2 Gy, and no elective node was irradiated. Concurrent and consolidation chemotherapy of fluorouracil (600 mg/m 2  , days 1-3) plus cisplatin (25 mg/m 2  , days 1-3) was administered every 4 weeks, for 4 cycles in total. The primary endpoint was 2-year progression-free survival (PFS).
RESULTS


Eighty-eight patients were enrolled in this study. The median age was 65 years (range: 45-75 years), and 69 patients (78.4%) were men. With the median follow-up of 26 (range: 3-95) months, the 2- and 5-year PFS were 39.3% and 36.9%, respectively, and overall survival (OS) were 57.1% and 39.2%, respectively. Tumor stage and concurrent chemotherapy were independent OS predictors. Major acute adverse events were myelosuppression and esophagitis, most of which were grades 1-2. Nine percent and 2.3% of patients had grade 3 acute esophagitis and late esophageal strictures, respectively.
CONCLUSIONS


Sequential boost to 66 Gy by IMRT with chemotherapy was safe and effective for inoperable ESCC. A randomized phase III study to compare with standard dose of 50 Gy is warranted.",2020,"Major acute adverse events were myelosuppression and esophagitis, most of which were grades 1-2.","['Eighty-eight patients were enrolled in this study', 'The median age was 65\xa0years (range: 45-75\xa0years), and 69 patients (78.4%) were men', 'Patients with histologically or cytologically proven inoperable ESCC', 'patients with inoperable esophageal squamous cell carcinoma (ESCC', 'inoperable esophageal squamous cell carcinoma']","['IMRT with chemotherapy', 'intensity-modulated radiation therapy (IMRT) with chemotherapy', 'Concurrent and consolidation chemotherapy of fluorouracil', 'cisplatin', 'Sequential boost of intensity-modulated radiotherapy with chemotherapy']","['overall survival (OS', '2-year progression-free survival (PFS', 'grade 3 acute esophagitis and late esophageal strictures', 'myelosuppression and esophagitis', '2- and 5-year PFS', 'efficacy and tolerability']","[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0149882', 'cui_str': 'Acute esophagitis (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C4551650', 'cui_str': 'Esophageal Stricture'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]",88.0,0.0457988,"Major acute adverse events were myelosuppression and esophagitis, most of which were grades 1-2.","[{'ForeName': 'Xing-Wen', 'Initials': 'XW', 'LastName': 'Fan', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Hong-Bing', 'Initials': 'HB', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jing-Fang', 'Initials': 'JF', 'LastName': 'Mao', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Kai-Liang', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Cancer medicine,['10.1002/cam4.2933']
142,31238343,Effects of Partially Hydrolyzed Formula on Severity and Outcomes of Neonatal Abstinence Syndrome.,"OBJECTIVE


This study compares the effect of partially hydrolyzed formula (PHF) and standard formula (SF) on the severity and short-term outcomes of neonatal abstinence syndrome (NAS).
STUDY DESIGN


We performed a retrospective chart review of 124 opioid-dependent mothers and their term or near-term infants. Infants were categorized according to the predominant type of formula consumed during the hospital stay. Finnegan's scale was used to assess symptoms of withdrawal.
RESULTS


A total of 110 infants met our inclusion criteria. Thirty-four (31%) infants were fed predominantly PHF, 60 (54%) infants were fed SF, and 16 (15%) infants were fed maternal breast milk. There was no difference between the infants in the PHF and SF groups with respect to requirement of morphine (MSO 4 ) therapy, maximum dose of MSO 4  used, duration of MSO 4  treatment or length of hospital stay after performing multivariate analyses to control for type of drug used by the mother, maternal smoking, regular prenatal care, inborn status, and maximum Finnegan score prior to MSO 4  treatment.
CONCLUSION


Use of PHF failed to impact short-term outcomes in infants treated for NAS including maximum MSO 4  dose, duration of MSO 4  treatment, and length of hospital stay. A prospective randomized controlled trial may be indicated to confirm this finding.",2020,"There was no difference between the infants in the PHF and SF groups with respect to requirement of morphine (MSO 4 ) therapy, maximum dose of MSO 4  used, duration of MSO 4  treatment or length of hospital stay after performing multivariate analyses to control for type of drug used by the mother, maternal smoking, regular prenatal care, inborn status, and maximum Finnegan score prior to MSO 4  treatment.
","['neonatal abstinence syndrome (NAS', 'Thirty-four (31%) infants were fed predominantly PHF, 60 (54%) infants were fed SF, and 16 (15%) infants were fed maternal breast milk', '124 opioid-dependent mothers and their term or near-term infants', '110 infants met our inclusion criteria']","['Partially Hydrolyzed Formula', 'morphine', 'partially hydrolyzed formula (PHF) and standard formula (SF', 'PHF']","['Severity and Outcomes of Neonatal Abstinence Syndrome', 'duration of MSO 4  treatment or length of hospital stay', 'length of hospital stay']","[{'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.0275786,"There was no difference between the infants in the PHF and SF groups with respect to requirement of morphine (MSO 4 ) therapy, maximum dose of MSO 4  used, duration of MSO 4  treatment or length of hospital stay after performing multivariate analyses to control for type of drug used by the mother, maternal smoking, regular prenatal care, inborn status, and maximum Finnegan score prior to MSO 4  treatment.
","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Alsaleem', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, The State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Berkelhamer', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, The State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, The State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Lorin M', 'Initials': 'LM', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics, The State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Reynolds', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, The State University of New York at Buffalo, Buffalo, New York.'}]",American journal of perinatology,['10.1055/s-0039-1692684']
143,31375713,Enhanced Depth Navigation Through Augmented Reality Depth Mapping in Patients with Low Vision.,"Patients diagnosed with Retinitis Pigmentosa (RP) show, in the advanced stage of the disease, severely restricted peripheral vision causing poor mobility and decline in quality of life. This vision loss causes difficulty identifying obstacles and their relative distances. Thus, RP patients use mobility aids such as canes to navigate, especially in dark environments. A number of high-tech visual aids using virtual reality (VR) and sensory substitution have been developed to support or supplant traditional visual aids. These have not achieved widespread use because they are difficult to use or block off residual vision. This paper presents a unique depth to high-contrast pseudocolor mapping overlay developed and tested on a Microsoft Hololens 1 as a low vision aid for RP patients. A single-masked and randomized trial of the AR pseudocolor low vision aid to evaluate real world mobility and near obstacle avoidance was conducted consisting of 10 RP subjects. An FDA-validated functional obstacle course and a custom-made grasping setup were used. The use of the AR visual aid reduced collisions by 50% in mobility testing (p = 0.02), and by 70% in grasp testing (p = 0.03). This paper introduces a new technique, the pseudocolor wireframe, and reports the first significant statistics showing improvements for the population of RP patients with mobility and grasp.",2019,"The use of the AR visual aid reduced collisions by 50% in mobility testing (p = 0.02), and by 70% in grasp testing (p = 0.03).","['Patients with Low Vision', '10 RP subjects', 'Patients diagnosed with Retinitis Pigmentosa (RP']","['virtual reality (VR) and sensory substitution', 'AR pseudocolor low vision']",['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042798', 'cui_str': 'Vision, Diminished'}, {'cui': 'C0035334', 'cui_str': 'Pigmentary Retinopathy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0042798', 'cui_str': 'Vision, Diminished'}]",[{'cui': 'C0034380'}],,0.0267623,"The use of the AR visual aid reduced collisions by 50% in mobility testing (p = 0.02), and by 70% in grasp testing (p = 0.03).","[{'ForeName': 'Anastasios Nikolas', 'Initials': 'AN', 'LastName': 'Angelopoulos', 'Affiliation': 'University of Southern California, USC Ginsburg Institute for Biomedical Therapeutics, Los Angeles, 90033, USA. nikolasa@stanford.edu.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ameri', 'Affiliation': 'University of Southern California, USC Ginsburg Institute for Biomedical Therapeutics, Los Angeles, 90033, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Mitra', 'Affiliation': 'University of Southern California, USC Ginsburg Institute for Biomedical Therapeutics, Los Angeles, 90033, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Humayun', 'Affiliation': 'University of Southern California, USC Ginsburg Institute for Biomedical Therapeutics, Los Angeles, 90033, USA. humayun@med.usc.edu.'}]",Scientific reports,['10.1038/s41598-019-47397-w']
144,31641203,A secondary analysis of testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI) on untrained muscles after spinal cord injury: a pilot randomized clinical trial.,"STUDY DESIGN


Secondary analysis of a clinical trial.
OBJECTIVES


To perform a secondary analysis on the effects of neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT) compared with TRT on the untrained muscles after spinal cord injury (SCI).
SETTING


Medical research center.
METHODS


Twenty-two men with chronic motor complete SCI were randomized into TRT + RT group (n = 11) or TRT group (n = 11). Both groups received 16 weeks of TRT (2-6 mg/day) via testosterone patches. The TRT + RT group received twice weekly progressive RT of the knee extensor muscles using electrical stimulation and ankle weights. Magnetic resonance images were captured to measure cross-sectional areas (CSAs) of trunk, glutei, and leg muscles.
RESULTS


Total and absolute gluteus maximus m. (14%, P = 0.003 and 16%, P = 0.001), gluteus medius m. (10%; P = 0.008 and 14%; P = 0.02), and total glutei m. (8%, P = 0.01 and 11%, P = 0.005) CSAs increased overtime for the TRT + RT group. Mean between-group differences of 2.86 (95% CI: 0.30, 5.4), 1.89 (95% CI: 0.23, 3.58) and 5.27 (95% CI: 0.90, 9.69) cm 2  were noted for absolute gluteus maximus, total gluteus medius and total glutei CSAs, respectively (P < 0.05). Trunk muscle CSAs showed a trend towards an interaction between groups.
CONCLUSIONS


RT combined with low-dose TRT results in significant hypertrophy compared with TRT only on the adjacent untrained glutei muscles. Trunk muscles may require direct stimulation to evoke hypertrophy. These exploratory findings may be of clinical relevance in the reduction of incidence and severity of pelvic pressure injuries.",2020,"RESULTS


Total and absolute gluteus maximus m. (14%, P = ","['untrained muscles after spinal cord injury (SCI', 'untrained muscles after spinal cord injury', 'Twenty-two men with chronic motor complete SCI']","['testosterone and electrically evoked resistance training versus testosterone only (TEREX-SCI', 'testosterone patches', 'TRT\u2009+\u2009RT', 'TRT', 'neuromuscular electrical stimulation resistance training (RT) combined with testosterone replacement therapy (TRT', 'CSAs']","['total glutei m', 'absolute gluteus maximus, total gluteus medius and total glutei CSAs']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",22.0,0.145549,"RESULTS


Total and absolute gluteus maximus m. (14%, P = ","[{'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Gorgey', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA. ashraf.gorgey@va.gov.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Abilmona', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Sima', 'Affiliation': 'Department of Biostatistics, School of Medicine Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Refka E', 'Initials': 'RE', 'LastName': 'Khalil', 'Affiliation': 'Spinal Cord Injury and Disorders, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Radiology Service, Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Adler', 'Affiliation': 'Endocrinology Section Hunter Holmes McGuire VA Medical Center, Richmond, VA, USA.'}]",Spinal cord,['10.1038/s41393-019-0364-3']
145,32312357,Does the unified protocol really change neuroticism? Results from a randomized trial.,"BACKGROUND


Neuroticism is associated with the onset and maintenance of a number of mental health conditions, as well as a number of deleterious outcomes (e.g. physical health problems, higher divorce rates, lost productivity, and increased treatment seeking); thus, the consideration of whether this trait can be addressed in treatment is warranted. To date, outcome research has yielded mixed results regarding neuroticism's responsiveness to treatment, perhaps due to the fact that study interventions are typically designed to target disorder symptoms rather than neuroticism itself. The purpose of the current study was to explore whether a course of treatment with the unified protocol (UP), a transdiagnostic intervention that was explicitly developed to target neuroticism, results in greater reductions in neuroticism compared to gold-standard, symptom focused cognitive behavioral therapy (CBT) protocols and a waitlist (WL) control condition.
METHOD


Patients with principal anxiety disorders (N = 223) were included in this study. They completed a validated self-report measure of neuroticism, as well as clinician-rated measures of psychological symptoms.
RESULTS


At week 16, participants in the UP condition exhibited significantly lower levels of neuroticism than participants in the symptom-focused CBT (t(218) = -2.17, p = 0.03, d = -0.32) and WL conditions(t(207) = -2.33, p = 0.02, d = -0.43), and these group differences remained after controlling for simultaneous fluctuations in depression and anxiety symptoms.
CONCLUSIONS


Treatment effects on neuroticism may be most robust when this trait is explicitly targeted.",2020,"At week 16, participants in the UP condition exhibited significantly lower levels of neuroticism than participants in the symptom-focused CBT (t(218) =",['Patients with principal anxiety disorders (N = 223'],['cognitive behavioral therapy (CBT) protocols and a waitlist (WL) control condition'],"['depression and anxiety symptoms', 'levels of neuroticism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0564509', 'cui_str': 'Level of neuroticism'}]",223.0,0.0475881,"At week 16, participants in the UP condition exhibited significantly lower levels of neuroticism than participants in the symptom-focused CBT (t(218) =","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY40506, USA.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jarvi Steele', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Brittany K', 'Initials': 'BK', 'LastName': 'Woods', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Mengxing', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}]",Psychological medicine,['10.1017/S0033291720000975']
146,25619196,Patient Beliefs About Colon Cancer Screening.,"Only about half of eligible individuals undergo colon cancer screening. We have limited knowledge about the patient beliefs that adversely affect screening decisions and about which beliefs might be amenable to change through education. As part of a clinical trial, 641 rural Iowans, aged 52 to 79 years, reported their beliefs about colon cancer screening in response to a mailed questionnaire. Consenting subjects were randomized into four groups, which were distinguished by four levels of increasingly intensive efforts to promote screening. Two of the groups received mailed educational materials and completed a follow-up questionnaire, which allowed us to determine whether their beliefs about screening changed following the education. We also completed a factor analysis to identify underlying (latent) factors that might explain the responses to 33 questions about readiness, attitudes, and perceived barriers related to colon cancer screening. The strongest predictors of a patient's stated readiness to be screened were a physician's recommendation to be screened (1 point difference on 10-point Likert scale, 95 % confidence interval [CI], 0.5 to 1.6 point difference), a family history of colon cancer (0.85-point Likert scale difference, 95 % CI, 0.1 to 1.6), and a belief that health-care decisions should be mostly left to physicians rather than patients (Spearman correlation coefficient 0.21, P < .001). Of the 33 questionnaire items about screening beliefs, 11 (33 %) changed favorably following the educational intervention. In the factor analysis, the 33 items were reduced to 8 underlying factors, such as being too busy to undergo screening and worries about screening procedures. We found a limited number of underlying factors that may help explain patient resistance to colon cancer screening.",2016,"Of the 33 questionnaire items about screening beliefs, 11 (33 %) changed favorably following the educational intervention.","['Consenting subjects', '641 rural Iowans, aged 52 to 79 years, reported their beliefs about colon cancer screening in response to a mailed questionnaire', 'eligible individuals undergo colon cancer screening']",['mailed educational materials'],['family history of colon cancer'],"[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0554837', 'cui_str': 'Colon cancer screening'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",641.0,0.0559912,"Of the 33 questionnaire items about screening beliefs, 11 (33 %) changed favorably following the educational intervention.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Ely', 'Affiliation': 'Department of Family Medicine, Joy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, USA. john-ely@uiowa.edu.'}, {'ForeName': 'Barcey T', 'Initials': 'BT', 'LastName': 'Levy', 'Affiliation': 'Department of Family Medicine, Joy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Daly', 'Affiliation': 'Department of Family Medicine, Joy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Family Medicine, Joy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-015-0792-5']
147,32022463,A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: Results of the ALLRE08 PETHEMA trial.,"BACKGROUND


Pediatric-based or -inspired trials have improved the prognosis of adolescents and young adults (AYA) with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL).
METHODS


This study reports the results of treatment of the ALLRE08 trial, a full pediatric trial for AYA aged 15-30 years with standard-risk (SR) ALL.
RESULTS


From 2008 to 2018, 89 patients (38 adolescents [15-18 years] and 51 young adults [YA, 19-30 years], median age: 20 [15-29] years) were enrolled in the ALLRE08 trial. The complete response (CR) was 95%. Twenty-two patients were transferred to a high-risk (HR) protocol because of poor marrow response on day 14 (n = 20) or high-level of end-induction minimal residual response (MRD ≥ 0.25%, n = 2). Cumulative incidence of relapse (CIR) at 5 years was 35% (95%CI: 23%-47%), with significant differences between adolescents and YA: 13% (4%-28%) vs 52% (34%-67%), P = .012. No treatment-related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial. The estimated 5-year overall survival (OS) was 74% (95%CI: 63%-85%), with significantly higher rates for adolescents vs YA: 87% (95%CI: 74%-100%) vs 63% (46%-80%), P = .021. Although CIR or OS were lower in patients who were transferred to a HR trial, the differences were not statistically significant (CIR: 34% [21%-47%] vs 37% [14%-61%]; OS: 78% [66%-90%] vs 61% [31%;91%]).
CONCLUSION


A full pediatric trial is feasible and effective for AYA with Ph-neg, SR-ALL, with better results for adolescents than for YA. Outcome of patients with poor early response rescued with a HR trial was not significantly inferior.",2020,No treatment-related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial.,"['From 2008 to 2018, 89 patients (38 adolescents [15-18\xa0years] and 51 young adults [YA, 19-30\xa0years], median age: 20 [15-29] years', 'adolescents and young adults (AYA) with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL', 'adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia', 'full pediatric trial for AYA aged 15-30\xa0years with standard-risk (SR) ALL', 'Twenty-two patients were transferred to a high-risk (HR) protocol because of poor marrow response on day 14 (n\xa0=\xa020) or high-level of end-induction minimal residual response (MRD\xa0≥\xa00.25%, n\xa0=\xa02']",[],"['mortality', 'CIR or OS', '5-year overall survival (OS', 'Cumulative incidence of relapse (CIR', 'complete response (CR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3888511', 'cui_str': 'Philadelphia chromosome negative'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",22.0,0.2899,No treatment-related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial.,"[{'ForeName': 'Josep-Maria', 'Initials': 'JM', 'LastName': 'Ribera', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Morgades', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Departments of Clinical Hematology, Hospital Universitari i Politècnic La Fe, CIBERONC, Instituto Carlos III, Valencia, Spain, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Tormo', 'Affiliation': 'Departments of Clinical Hematology, Hospital Clínico Valencia, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martínez-Carballeira', 'Affiliation': 'Hospital Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Campos', 'Affiliation': 'Departments of Clinical Hematology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gil', 'Affiliation': 'Departments of Clinical Hematology, Hospital General Universitario de Alicante, Alicante, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Barba', 'Affiliation': ""Departments of Clinical Hematology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'García-Boyero', 'Affiliation': 'Departments of Clinical Hematology, Hospital General Universitario de Castellón, Castelló, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coll', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Josep Trueta, Girona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Pedreño', 'Affiliation': 'Departments of Clinical Hematology, Hospital Dr. Peset, Valencia, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Ribera', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Mercadal', 'Affiliation': ""Departments of Clinical Hematology, ICO-Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Vives', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Novo', 'Affiliation': 'Departments of Clinical Hematology, Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Eulàlia', 'Initials': 'E', 'LastName': 'Genescà', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jesús-María', 'Initials': 'JM', 'LastName': 'Hernández-Rivas', 'Affiliation': 'Departments of Clinical Hematology, Hospital Clínico Universitario, Cancer Research Center (IBMCC-CSIC/USAL), Cytometry Service CIBERONC, Salamanca, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Bergua', 'Affiliation': 'Departments of Clinical Hematology, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'María-Luz', 'Initials': 'ML', 'LastName': 'Amigo', 'Affiliation': 'Departments of Clinical Hematology, Hospital Morales Meseguer, Murcia, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Vall-Llovera', 'Affiliation': 'Departments of Clinical Hematology, Hospital Mútua de Terrassa, Terrassa, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Martínez-Sánchez', 'Affiliation': 'Departments of Clinical Hematology, Hospital Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Calbacho', 'Affiliation': 'Departments of Clinical Hematology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'García-Cadenas', 'Affiliation': 'Departments of Clinical Hematology, Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Garcia-Guiñon', 'Affiliation': 'Departments of Clinical Hematology, Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Departments of Clinical Hematology, Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cervera', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Evarist', 'Initials': 'E', 'LastName': 'Feliu', 'Affiliation': 'Departments of Clinical Hematology, ICO-Hospital Germans Trias i Pujol. Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Orfao', 'Affiliation': 'Departments of Clinical Hematology, Hospital Clínico Universitario, Cancer Research Center (IBMCC-CSIC/USAL), Cytometry Service CIBERONC, Salamanca, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer medicine,['10.1002/cam4.2814']
148,31764994,A fruit diet rather than invertebrate diet maintains a robust innate immunity in an omnivorous tropical songbird.,"Diet alteration may lead to nutrient limitations even in the absence of food limitation, and this may affect physiological functions, including immunity. Nutrient limitations may also affect the maintenance of body mass and key life-history events that may affect immune function. Yet, variation in immune function is largely attributed to energetic trade-offs rather than specific nutrient constraints. To test the effect of diet on life-history traits, we tested how diet composition affects innate immune function, body mass and moult separately and in combination with each other, and then used path analyses to generate hypotheses about the mechanistic connections between immunity and body mass under different diet compositions. We performed a balanced parallel and crossover design experiment with omnivorous common bulbuls Pycnonotus barbatus in out-door aviaries in Nigeria. We fed 40 wild-caught bulbuls ad libitum on fruits or invertebrates for 24 weeks, switching half of each group between treatments after 12 weeks. We assessed innate immune indices (haptoglobin, nitric oxide and ovotransferrin concentrations, and haemagglutination and haemolysis titres), body mass and primary moult, fortnightly. We simplified immune indices into three principal components (PCs), but we explored mechanistic connections between diet, body mass and each immune index separately. Fruit-fed bulbuls had higher body mass, earlier moult and showed higher values for two of the three immune PCs compared to invertebrate-fed bulbuls. These effects were reversed when we switched bulbuls between treatments after 12 weeks. Exploring the correlations between immune function, body mass and moult, showed that an increase in immune function was associated with a decrease in body mass and delayed moult in invertebrate-fed bulbuls, while fruit-fed bulbuls maintained body mass despite variation in immune function. Path analyses indicated that diet composition was most likely to affect body mass and immune indices directly and independently from each other. Only haptoglobin concentration was indirectly linked to diet composition via body mass. We demonstrated a causal effect of diet composition on innate immune function, body mass and moult: bulbuls were in a better condition when fed on fruits than invertebrates, confirming that innate immunity is nutrient specific. Our results are unique because they show a reversible effect of diet composition on wild adult birds whose immune systems are presumably fully developed and adapted to wild conditions-demonstrating a short-term consequence of diet alteration on life-history traits.",2020,"Fruit fed bulbuls had higher body mass, earlier moult and showed higher values for two of the three immune PCs compared to invertebrate fed bulbuls.",['omnivorous Common Bulbuls Pycnonotus barbatus in out-door aviaries in Nigeria'],['diet composition'],"['haptoglobin concentration', 'immune function', 'innate immune indices (haptoglobin, nitric oxide and ovotransferrin concentrations, and haemagglutination and haemolysis titres), body mass', 'body mass']","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1060466', 'cui_str': 'Genus Pycnonotus'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0919773', 'cui_str': 'Haptoglobin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0009629', 'cui_str': 'Ovotransferrin'}, {'cui': 'C0018905', 'cui_str': 'Hemagglutination assay (procedure)'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",40.0,0.0263374,"Fruit fed bulbuls had higher body mass, earlier moult and showed higher values for two of the three immune PCs compared to invertebrate fed bulbuls.","[{'ForeName': 'Chima J', 'Initials': 'CJ', 'LastName': 'Nwaogu', 'Affiliation': 'Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Annabet', 'Initials': 'A', 'LastName': 'Galema', 'Affiliation': 'Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Cresswell', 'Affiliation': 'School of Biology, University of St Andrews, St Andrews Fife, UK.'}, {'ForeName': 'Maurine W', 'Initials': 'MW', 'LastName': 'Dietz', 'Affiliation': 'Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'B Irene', 'Initials': 'BI', 'LastName': 'Tieleman', 'Affiliation': 'Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The Netherlands.'}]",The Journal of animal ecology,['10.1111/1365-2656.13152']
149,32064794,Effect of anlotinib as a third- or further-line therapy in advanced non-small cell lung cancer patients with different histologic types: Subgroup analysis in the ALTER0303 trial.,"BACKGROUND


Anlotinib showed significant survival benefits in advanced non-small cell lung cancer (NSCLC) patients as a third- or further-line treatment in the ALTER0303 trial. We aimed to evaluate the efficacy of anlotinib in patients with different histologies.
METHODS


The ALTER0303 trial was a randomized, open-label, phase 3 study of anlotinib in NSCLC patients previously treated with at least two lines of chemotherapy or a tyrosine kinase inhibitor (TKI) in 31 centers in China. Patients were randomly assigned at a 2:1 ratio to receive anlotinib (12 mg QD from days 1 to 14 of a 21-day cycle) or placebo until progression or intolerable toxicity. The primary endpoint was overall survival (OS). We assessed the efficacy of anlotinib in histological subgroups in the full analysis set.
RESULTS


In the ALTER0303 trial, 336 patients had the histological subtype of adenocarcinoma (ACC), 86 patients had the histological subtype of squamous cell carcinoma (SCC), and 15 patients had another subtype. In the ACC subgroup, the median OS time was significantly improved with anlotinib compared with placebo (9.6 months vs 6.9 months, P = .0051), as was the median progression-free survival (PFS) time (5.5 months vs 1.4 months, P < .0001). In the SCC subgroup, the median OS time was 10.7 months in the anlotinib group and 6.5 months in the placebo group (P = .2570), and the median PFS time was 4.8 months and 2.7 months (P = .0004), respectively. The common adverse events observed in the SCC and ACC subgroups were similar.
CONCLUSIONS


Our findings suggest that anlotinib significantly improves PFS and OS in ACC patients and has a tendency to prolong survival in SCC patients.",2020,"In the ACC subgroup, the median OS time was significantly improved with anlotinib compared with placebo (9.6 months vs 6.9 months, P = .0051), as was the median progression-free survival (PFS) time (5.5 months vs 1.4 months, P < .0001).","['advanced non-small cell lung cancer patients with different histologic types', 'patients with different histologies', '336 patients had the histological subtype of adenocarcinoma (ACC), 86 patients had the histological subtype of squamous cell carcinoma (SCC), and 15 patients had another subtype', 'NSCLC patients previously treated with at least two lines of chemotherapy or a tyrosine kinase inhibitor (TKI) in 31 centers in China', 'advanced non-small cell lung cancer (NSCLC) patients']","['anlotinib as a third- or further-line therapy', 'anlotinib', 'placebo']","['overall survival (OS', 'median OS time', 'PFS and OS', 'survival benefits', 'median progression-free survival (PFS) time', 'median PFS time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449574', 'cui_str': 'Histological type (attribute)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C4519250', 'cui_str': 'anlotinib'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",336.0,0.411139,"In the ACC subgroup, the median OS time was significantly improved with anlotinib compared with placebo (9.6 months vs 6.9 months, P = .0051), as was the median progression-free survival (PFS) time (5.5 months vs 1.4 months, P < .0001).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Tianjin Medical University Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Lin Yi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Zhehai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Weiqiang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Lanzhou Military General Hospital, Lanzhou, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Kejun', 'Initials': 'K', 'LastName': 'Nan', 'Affiliation': ""The First Affiliated Hospital of Xi'An Jiaotong University, Xi'an, China.""}, {'ForeName': 'Faguang', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Tang Du Hospital, Xi'an, China.""}, {'ForeName': 'Baolan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Jilin Cancer Hospital, Jilin, China.'}]",Cancer medicine,['10.1002/cam4.2913']
150,31884682,Eight-year post-trial follow-up of health care and long-term care costs of tele-based health coaching.,"OBJECTIVE


To evaluate the long-term effect of telephone health coaching on health care and long-term care (LTC) costs in type 2 diabetes (T2D) and coronary artery disease (CAD) patients.
DATA SOURCES/STUDY SETTING


Randomized controlled trial (RCT) data were linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year economic evaluation was conducted.
STUDY DESIGN


A total of 1,535 patients (≥45 years) were randomized to the intervention (n = 1034) and control groups (n = 501). The intervention group received monthly telephone health coaching for 12 months. Usual health care and LTC were provided for both groups.
PRINCIPAL FINDINGS


Intention-to-treat analysis showed no significant change in total health and long-term care costs (intervention effect €1248 [3 percent relative reduction], CI -6347 to 2217) in the intervention compared to the control group. There were also no significant changes among subgroups of patients with T2D or CAD.
CONCLUSIONS


Health coaching had a nonsignificant effect on health care and long-term care costs in the 8-year follow-up among patients with T2D or CAD. More research is needed to study, which patient groups, at which state of the disease trajectory of T2D and cardiovascular disease, would best benefit from health coaching.",2020,"CONCLUSIONS


Health coaching had a nonsignificant effect on health care and long-term care costs in the 8-year follow-up among patients with T2D or CAD.","['patients with T2D or CAD', '1,535 patients (≥45\xa0years', 'type 2 diabetes (T2D) and coronary artery disease (CAD) patients']","['tele-based health coaching', 'monthly telephone health coaching', 'telephone health coaching', 'Health coaching']","['health care and long-term care (LTC) costs', 'health care and long-term care costs', 'total health and long-term care costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0023977'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",1535.0,0.0417793,"CONCLUSIONS


Health coaching had a nonsignificant effect on health care and long-term care costs in the 8-year follow-up among patients with T2D or CAD.","[{'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Mustonen', 'Affiliation': 'Päijät-Häme Joint Authority for Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'Iiris', 'Initials': 'I', 'LastName': 'Hörhammer', 'Affiliation': 'Healthcare Engineering, Management and Architecture Institute, Aalto University, Aalto, Finland.'}, {'ForeName': 'Pilvikki', 'Initials': 'P', 'LastName': 'Absetz', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Patja', 'Affiliation': 'Department of Public Health, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lammintakanen', 'Affiliation': 'University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Martti', 'Initials': 'M', 'LastName': 'Talja', 'Affiliation': 'Päijät-Häme Joint Authority for Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Kuronen', 'Affiliation': 'Päijät-Häme Joint Authority for Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'Miika', 'Initials': 'M', 'LastName': 'Linna', 'Affiliation': 'Healthcare Engineering, Management and Architecture Institute, Aalto University, Aalto, Finland.'}]",Health services research,['10.1111/1475-6773.13251']
151,31957269,A randomized trial of nurse-administered behavioral interventions to manage anticipatory nausea and vomiting in chemotherapy.,"PURPOSE


Chemotherapy side effects diminish quality of life and can lead to treatment delay. Nausea and vomiting can occur prior to chemotherapy because of classical conditioning. We studied the effects of 20-minute behavioral interventions, administered by oncology nurses, of higher intensity (mindfulness relaxation-MR) or lower intensity (relaxing music-RM), on anticipatory nausea and vomiting (ANV).
PATIENTS AND METHODS


Patients undergoing chemotherapy for solid tumors were randomized to MR (N = 160), RM (N = 159), or standard care SC (N = 155). Subjects were mostly female (91.8%) and white (86.1%) with breast cancer (85%). Most patients had early stage disease (Stage I: 26%; II: 52.9%; III: 19%; IV: 0.1%). Anticipatory nausea and vomiting were assessed at the midpoint and end of the chemotherapy course using the Morrow Assessment of Nausea and Emesis (MANE).
RESULTS


Compared to SC, there was reduced anticipatory nausea at the midpoint of chemotherapy in those receiving MR (OR 0.44, 95% CI 0.20-0.93) and RM (OR 0.40, 95% CI 0.20-0.93), controlling for age, sex, cancer stage, and emetogenic level of chemotherapy. There was no difference between treatment groups in anticipatory nausea at the end of chemotherapy or in anticipatory vomiting and postchemotherapy nausea and vomiting at either time point.
CONCLUSION


A brief nurse-delivered behavioral intervention can reduce midpoint ANV associated with chemotherapy.",2020,"There was no difference between treatment groups in anticipatory nausea at the end of chemotherapy or in anticipatory vomiting and postchemotherapy nausea and vomiting at either time point.
","['Patients undergoing chemotherapy for solid tumors', 'Subjects were mostly female (91.8%) and white (86.1%) with breast cancer (85']","['standard care SC', 'MR', '20-minute behavioral interventions, administered by oncology nurses, of higher intensity (mindfulness relaxation-MR) or lower intensity (relaxing music-RM', 'nurse-administered behavioral interventions', 'behavioral intervention']","['RM', 'anticipatory vomiting and postchemotherapy nausea and vomiting', 'anticipatory nausea', 'anticipatory nausea and vomiting', 'anticipatory nausea and vomiting (ANV', 'early stage disease', 'Nausea and vomiting', 'Nausea and Emesis (MANE', 'Anticipatory nausea and vomiting', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0557529', 'cui_str': 'Oncology nurse (occupation)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0042964', 'cui_str': 'Vomiting, Anticipatory'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C3854611', 'cui_str': 'Anticipatory nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0034380'}]",,0.0760695,"There was no difference between treatment groups in anticipatory nausea at the end of chemotherapy or in anticipatory vomiting and postchemotherapy nausea and vomiting at either time point.
","[{'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Hunter', 'Affiliation': 'Sinai Health System, The University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maunder', 'Affiliation': 'Sinai Health System, The University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Dawen', 'Initials': 'D', 'LastName': 'Sui', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Esplen', 'Affiliation': 'Princess Margaret Cancer Centre, de Souza Institute, Toronto, ON, Canada.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chaoul', 'Affiliation': 'Department of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fisch', 'Affiliation': 'Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Roland L', 'Initials': 'RL', 'LastName': 'Bassett', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marlys M', 'Initials': 'MM', 'LastName': 'Harden-Harrison', 'Affiliation': 'Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Lagrone', 'Affiliation': 'Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Wong', 'Affiliation': 'Baylor Scott and White Health, Temple, TX, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Baez-Diaz', 'Affiliation': 'Puerto Rico MUNCORP, San Juan, PR, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of General Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Cancer medicine,['10.1002/cam4.2863']
152,32310129,Transaxillary compared with transcarotid access for TAVR: a propensity-matched comparison from a French multicentre registry.,"AIMS


No randomised study comparing the outcomes of transcarotid (TC) and transaxillary (TAx) TAVR has been conducted to date. The purpose of this study was to understand which approach should be the preferred alternative by comparing their outcomes using a propensity-matched comparison in a French multicentre registry.
METHODS AND RESULTS


From 2010 to 2018, a French multicentre prospective registry included 502 patients, with 374 undergoing TC-TAVR and 128 TAx-TAVR for symptomatic aortic stenosis. Patients treated through TAx access were matched 1:2 with patients treated through the TC route by using a propensity score (20 clinical, anatomical and procedural variables) and by date of the procedure. The first outcome was mortality at one-month follow-up. The second outcome was one-month stroke/transient ischaemic attack (TIA). In propensity-matched analyses, the incidence of the primary outcome was similar in the TAx and TC groups (TAx 5.5% vs TC 4.5%, OR 1.23, 95% CI: 0.40-3.70). The secondary outcome was similar in TAx (3.2%) and TC (6.8%, OR 0.52, 95% CI: 0.14-1.84). Minor bleeding (2.7% vs 9.3%, OR 0.26, 95% CI: 0.07-0.92) and main access haematoma (3.6% vs 10.3%, OR 0.034, 95% CI: 0.09-0.92) were significantly more frequent with the TC access. One-month clinical efficacy and safety and one-year mortality did not differ according to the different routes.
CONCLUSIONS


One-month mortality, one-month stroke/TIA and one-year mortality are similar with TAx-TAVR and TC-TAVR. However, TC-TAVR is accompanied by more minor bleeding and main access haematoma compared with the transaxillary route.",2020,Minor bleeding (2.7% vs. 9.3%; OR=0.26; 95%CI:0.07-0.92) and main access hematoma (3.6% vs. 10.3%; OR=0.034; 95% CI:0.09-0.92) were significantly more frequent with the TC access.,['502 patients with n=374 undergoing TC-TAVR and n=128 TAx-TAVR for symptomatic aortic stenosis'],"['transcarotid (TC) and transaxillary (TAx) TAVR', 'TAVR', 'Transaxillary']","['1-month stroke/transient ischemic attack (TIA', 'efficacy and safety and 1-year mortality', 'similar in TAx', 'mortality', 'main access hematoma', 'mortality, 1-month stroke/TIA and 1-year mortality', 'Minor bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442341', 'cui_str': 'Transaxillary approach'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C0442341', 'cui_str': 'Transaxillary approach'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442341', 'cui_str': 'Transaxillary approach'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",502.0,0.0851933,Minor bleeding (2.7% vs. 9.3%; OR=0.26; 95%CI:0.07-0.92) and main access hematoma (3.6% vs. 10.3%; OR=0.034; 95% CI:0.09-0.92) were significantly more frequent with the TC access.,"[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Debry', 'Affiliation': 'Heart Team, Institute Cœur-Poumons, CHU Lille, Lille, France.'}, {'ForeName': 'Talel Raouf', 'Initials': 'TR', 'LastName': 'Trimech', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gandet', 'Affiliation': ''}, {'ForeName': 'Flavien', 'Initials': 'F', 'LastName': 'Vincent', 'Affiliation': ''}, {'ForeName': 'Ilir', 'Initials': 'I', 'LastName': 'Hysi', 'Affiliation': ''}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Delhaye', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': ''}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Koussa', 'Affiliation': ''}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Juthier', 'Affiliation': ''}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Leclercq', 'Affiliation': ''}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pécheux', 'Affiliation': ''}, {'ForeName': 'Saïd', 'Initials': 'S', 'LastName': 'Ghostine', 'Affiliation': ''}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Modine', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00117']
153,32052592,Brachio-basilic upper arm transposition fistulas vs. prosthetic brachio-axillary vascular access grafts-Which one is preferred for hemodialysis?,"INTRODUCTION


There is still controversy on the use of brachio-basilic upper arm transposition fistula (BBAVF) and prosthetic brachio-axillary vascular access grafts (BAPTFE) in patients with no suitable cephalic veins for creating an autogenous brachio-cephalic fistula.
METHODS


In a randomized controlled clinical trial, 60 hemodialysis patients who were not a suitable candidate for BCAVF were randomly assigned into two groups: BBAVF and BAPTFE. The patients were clinically followed up to 1 year and the patency rate and access-related complications were compared between the two groups.
FINDINGS


Access failure rate in the BBAVF and BAPTFE groups was 30.0% and 36.6%, respectively. The primary patency time was 232.73 ± 113.36 and 261.53 ± 147.37 days, respectively (P = 0.40). Thrombosis formation and infection were the two main causes for access failure, yet indicating no significant difference between the two groups (P > 0.05).
DISCUSSION


BBAVF and BAPTFE have comparable clinical outcomes in short-term follow-up. Therefore, BAPTFE can be used as an alternative vascular access for hemodialysis in patients who are not a suitable candidate for BBAVF.",2020,"The patients were clinically followed up to 1 year and the patency rate and access-related complications were compared between the two groups.
","['60 hemodialysis patients who were not a suitable candidate for BCAVF', 'patients with no suitable cephalic veins for creating an autogenous brachio-cephalic fistula', 'hemodialysis in patients who are not a suitable candidate for BBAVF']","['BBAVF and BAPTFE', 'Brachio-basilic upper arm transposition fistulas vs. prosthetic brachio-axillary vascular access grafts', 'brachio-basilic upper arm transposition fistula (BBAVF) and prosthetic brachio-axillary vascular access grafts (BAPTFE']","['Thrombosis formation and infection', 'patency rate and access-related complications', 'primary patency time']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C0040759', 'cui_str': 'Transposition (morphologic abnormality)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",60.0,0.0389302,"The patients were clinically followed up to 1 year and the patency rate and access-related complications were compared between the two groups.
","[{'ForeName': 'Pouya', 'Initials': 'P', 'LastName': 'Tayebi', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Gholamhossein', 'Initials': 'G', 'LastName': 'Kazemzadeh', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hadi Saeed', 'Initials': 'MHS', 'LastName': 'Modaghegh', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Kamyar', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Ravari', 'Affiliation': 'Vascular and Endovascular Surgery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12817']
154,32306485,Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder.,"BACKGROUND


Posttraumatic stress disorder (PTSD) has been associated with exaggerated threat processing and deficits in emotion modulation circuitry. It remains unknown how neural circuits are associated with response to evidence-based treatments for PTSD.
METHOD


We examined associations between PTSD symptoms and indicators of neural response in key emotion processing and modulation regions. Fifty-six military Veterans with PTSD were randomly assigned to one of three evidence-based treatments (prolonged exposure, sertraline, and PE plus sertraline) in a randomized clinical trial (""PROGrESS""; 2018, Contemp Clin Trials, 64, 128-138). Twenty-seven combat-exposed controls (CCs) served as a comparison group at pretreatment. Before and after PTSD treatment, functional magnetic resonance imaging was used to assess brain activation and connectivity during the validated Shifted Attention Emotion Appraisal Task (2003, J Neurosci, 23, 5627-5633; 2013, Biol Psychiatry, 73, 1045-1053).
RESULTS


Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement.
CONCLUSIONS


This study is one of the first to examine task-based activation and functional connectivity in a PTSD treatment trial, and provides evidence to suggest that activation in and connectivity between emotion processing and modulation regions are important predictors of treatment response.",2020,"RESULTS


Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement.
","['posttraumatic stress disorder', 'Posttraumatic stress disorder (PTSD', 'Fifty-six military Veterans with PTSD']","['evidence-based treatments (prolonged exposure, sertraline, and PE plus sertraline']","['emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions', 'brain activation and connectivity', 'subsequent PTSD symptom improvement']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",56.0,0.0198617,"RESULTS


Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement.
","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Porter', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'Research Service, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, VA Atlanta Healthcare System, Decatur, Georgia.'}]",Depression and anxiety,['10.1002/da.23022']
155,32108263,Effect of vitamin D deficiency on depressive symptoms in child and adolescent psychiatric patients: results of a randomized controlled trial.,"PURPOSE


While observational studies revealed inverse associations between serum vitamin D levels [25(OH)D] and depression, randomized controlled trials (RCT) in children and adolescents are lacking. This RCT examined the effect of an untreated vitamin D deficiency compared to an immediate vitamin D 3  supplementation on depression scores in children and adolescents during standard day and in-patient psychiatric treatment.
METHODS


Patients with vitamin D deficiency [25(OH)D ≤ 30 nmol/l] and at least mild depression [Beck Depression Inventory II (BDI-II) > 13] (n = 113) were 1:1 randomized into verum (VG; 2640 IU vitamin D 3 /d) or placebo group (PG) in a double-blind manner. During the intervention period of 28 days, both groups additionally received treatment as usual. BDI-II scores were assessed as primary outcome, DISYPS-II (Diagnostic System for Mental Disorders in Childhood and Adolescence, Self- and Parent Rating) and serum total 25(OH)D were secondary outcomes.
RESULTS


At admission, 49.3% of the screened patients (n = 280) had vitamin D deficiency. Although the intervention led to a higher increase of 25(OH)D levels in the VG than in the PG (treatment difference: + 14 ng/ml; 95% CI 4.86-23.77; p = 0.003), the change in BDI-II scores did not differ (+ 1.3; 95% CI - 2.22 to 4.81; p = 0.466). In contrast, DISYPS parental ratings revealed pronounced improvements of depressive symptoms in the VG (- 0.68; 95% CI - 1.23 to - 0.13; p = 0.016).
CONCLUSION


Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study. Future trials should consider clinician-rated depressive symptoms as primary outcome.
TRIAL REGISTRATION


""German Clinical Trials Register"" ( https://www.drks.de ), registration number: DRKS00009758.",2020,"Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study.","['Patients with vitamin D deficiency [25(OH)D\u2009≤\u200930\xa0nmol/l] and at least mild depression [Beck Depression Inventory II (BDI-II)\u2009>\u200913', 'children and adolescents during standard day and in-patient psychiatric treatment', 'n\u2009=\u2009113', 'children and adolescents are lacking', 'child and adolescent psychiatric patients']","['vitamin D supplementation', 'placebo', 'vitamin D deficiency', 'verum', 'immediate vitamin D 3  supplementation']","['depression scores', 'change in BDI-II scores', 'DISYPS-II (Diagnostic System for Mental Disorders in Childhood and Adolescence, Self- and Parent Rating) and serum total 25(OH)D', 'vitamin D deficiency', 'serum vitamin D levels [25(OH)D] and depression', 'BDI-II scores', '25(OH)D levels', 'depressive symptoms', 'self-rated depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0588006', 'cui_str': 'Mild depression (disorder)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178546', 'cui_str': 'Mental disorder in childhood'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.642682,"Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Libuda', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany. lars.libuda@uni-due.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Timmesfeld', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Antel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Hirtz', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bauer', 'Affiliation': 'Pediatric Endocrinology and Diabetology, Klinik für Kinderheilkunde II, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Führer', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Division of Laboratory Research, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Zwanziger', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Division of Laboratory Research, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Öztürk', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Langenbach', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hahn', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Ring', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Triinu', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hinney', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bühlmeier', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Hebebrand', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Grasemann', 'Affiliation': 'Pediatric Endocrinology and Diabetology, Klinik für Kinderheilkunde II, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Föcker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Virchowstr. 174, 45147, Essen, Germany.'}]",European journal of nutrition,['10.1007/s00394-020-02176-6']
156,32168058,Editor's Spotlight/Take 5: Does An Augmented Reality-based Portable Navigation System Improve the Accuracy of Acetabular Component Orientation During THA? A Randomized Controlled Trial.,,2020,,"[""Editor's Spotlight/Take 5""]",[],['Accuracy of Acetabular Component Orientation'],[],[],"[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]",,0.122553,,"[{'ForeName': 'Seth S', 'Initials': 'SS', 'LastName': 'Leopold', 'Affiliation': 'S. S. Leopold, Editor-in-Chief, Clinical Orthopaedics and Related Research®, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001216']
157,32096346,Nomograms to predict the long-time prognosis in patients with alpha-fetoprotein negative hepatocellular carcinoma following radical resection.,"BACKGROUND


To develop and validate nomograms that can be used to predict outcomes in individuals suffering alpha-fetoprotein (AFP) negative hepatocellular carcinoma (HCC) after radical resection.
METHODS


A total of 509 AFP-negative HCC patients who received hepatectomy between January 2009 and March 2013 in our center were randomized into training and validation cohorts. Nomograms for both overall and recurrence-free survival (OS and RFS, respectively) were established based on the predictors in the training cohort. Nomograms performance and discriminative power were assessed with concordance index (C-index) values and decision curve analyses (DCA). The results were validated in the validation cohort.
RESULTS


Alkaline phosphatase, liver cirrhosis, tumor size, satellite lesions, microvascular invasion, and Edmondson-Steiner grade were significantly linked to OS and RFS. Sex and tumor number were additional predictors for RFS. The OS nomogram had a C-index value of 0.742, which was better than that for the AJCC eighth edition (0.632), BCLC system (0.553), and JIS score (0.557) (all P < .001). The RFS nomogram C-index was 0.669, which was also superior to that of the AJCC eighth (0.608), BCLC stage (0.554), JIS score (0.551), and model of Gan et al (0.636) (P < .05 for all). Calibration curves indicated a good agreement between observed actual outcomes and predicted values. Kaplan-Meier curves and DCA indicated that nomograms were powerful in discrimination and clinical usefulness. These results were supported by the validation cohort.
CONCLUSIONS


These nomograms presented more accurate prognostic prediction in patients with AFP-negative HCC after hepatectomy.",2020,"The RFS nomogram C-index was 0.669, which was also superior to that of the AJCC eighth (0.608), BCLC stage (0.554), JIS score (0.551), and model of Gan et al (0.636) (P < .05 for all).","['individuals suffering alpha-fetoprotein (AFP) negative hepatocellular carcinoma (HCC) after radical resection', 'patients with AFP-negative HCC after hepatectomy', '509 AFP-negative HCC patients who received hepatectomy between January 2009 and March 2013 in our center', 'patients with alpha-fetoprotein negative hepatocellular carcinoma following radical resection']",[],"['BCLC stage (0.554), JIS score', 'BCLC system (0.553), and JIS score', 'Alkaline phosphatase, liver cirrhosis, tumor size, satellite lesions, microvascular invasion, and Edmondson-Steiner grade', 'concordance index (C-index) values and decision curve analyses (DCA', 'RFS nomogram C-index']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",[],"[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0332221', 'cui_str': 'Satellite (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0600203', 'cui_str': 'DCA'}, {'cui': 'C1450294', 'cui_str': 'Nomograms'}]",,0.0301097,"The RFS nomogram C-index was 0.669, which was also superior to that of the AJCC eighth (0.608), BCLC stage (0.554), JIS score (0.551), and model of Gan et al (0.636) (P < .05 for all).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Fu-Chen', 'Initials': 'FC', 'LastName': 'Liu', 'Affiliation': 'Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wei-Ping', 'Initials': 'WP', 'LastName': 'Zhou', 'Affiliation': 'Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Bei-Ge', 'Initials': 'BG', 'LastName': 'Jiang', 'Affiliation': 'Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ze-Ya', 'Initials': 'ZY', 'LastName': 'Pan', 'Affiliation': 'Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.'}]",Cancer medicine,['10.1002/cam4.2944']
158,31850603,"Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active- and placebo-controlled EAGLES trial.","BACKGROUND


Smoking rates are high in adults with anxiety disorders (ADs), yet little is known about the safety and efficacy of smoking-cessation pharmacotherapies in this group.
METHODS


Post hoc analyses in 712 smokers with AD (posttraumatic stress disorder [PTSD], n = 192; generalized anxiety disorder [GAD], n = 243; panic disorder [PD], n = 277) and in a nonpsychiatric cohort (NPC; n = 4,028). Participants were randomly assigned to varenicline, bupropion, nicotine-replacement therapy (NRT), or placebo plus weekly smoking-cessation counseling for 12 weeks, with 12 weeks follow-up. General linear models were used to test the effects of treatment group, cohort, and their interaction on neuropsychiatric adverse events (NPSAEs), and continuous abstinence weeks 9-12 (treatment) and 9-24 (follow-up).
RESULTS


NPSAE incidence for PTSD (6.9%), GAD (5.4%), and PD (6.2%) was higher versus NPC (2.1%), regardless of treatment. Across all treatments, smokers with PTSD (odds ratio [OR] = 0.58), GAD (OR = 0.72), and PD (OR = 0.53) had lower continuous abstinence rates weeks 9-12 (CAR9-12) versus NPC. Varenicline demonstrated superior efficacy to placebo in smokers with GAD and PD, respectively (OR = 4.53; 95% confidence interval [CI] = 1.20-17.10; and OR = 8.49; 95% CI = 1.57-45.78); NRT was superior to placebo in smokers with PD (OR = 7.42; 95% CI = 1.37-40.35). While there was no statistically significant effect of any treatment on CAR9-12 for smokers with PTSD, varenicline improved 7-day point prevalence abstinence at end of treatment in this subcohort.
CONCLUSION


Individuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking-cessation attempts, regardless of treatment. While the study was not powered to evaluate abstinence outcomes with these subgroups of smokers with ADs, varenicline provided significant benefit for cessation in those with GAD and PD, while NRT provided significant benefit for those with PD.",2020,"Individuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking-cessation attempts, regardless of treatment.","['adults with anxiety disorders (ADs', 'anxiety disorders', '712 smokers with AD (posttraumatic stress disorder [PTSD], n\u2009=\u2009192; generalized anxiety disorder [GAD], n\u2009=\u2009243; panic disorder [PD], n\u2009=\u2009277) and in a nonpsychiatric cohort (NPC; n\u2009=\u20094,028']","['pharmacotherapies', 'Varenicline', 'varenicline', 'placebo', 'varenicline, bupropion, nicotine-replacement therapy (NRT), or placebo plus weekly smoking-cessation counseling']","['Efficacy and safety', '7-day point prevalence abstinence', 'continuous abstinence rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}]","[{'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]",712.0,0.0608517,"Individuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking-cessation attempts, regardless of treatment.","[{'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, California.'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Russ', 'Affiliation': 'Global Product Development, Pfizer, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lawrence', 'Affiliation': 'Global Product Development, Pfizer, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Global Product Development, Pfizer, New York, New York.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Center for Addiction Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Anthenelli', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, California.'}]",Depression and anxiety,['10.1002/da.22982']
159,31962002,Patient-reported symptom burden as a prognostic factor in treatment with first-line cetuximab plus chemotherapy for unresectable metastatic colorectal cancer: Results of Phase II QUACK trial.,"BACKGROUND


It remains unclear whether patients' self-perceptions of symptoms at baseline clinically impact the prognostic relevance, treatment efficacy, or toxicity profiles in metastatic colorectal cancer (mCRC) patients treated with the first-line cetuximab and standard chemotherapy.
METHODS


The data were collected from a prospective trial that assessed the relationships between quality of life (QOL), treatment efficacy, and adverse events (AEs).
RESULTS


The analysis of 137 mCRC patients revealed a significant association between the presence of baseline tumor-related symptoms and a lower overall survival (OS) compared to the absence of symptoms (HR, 2.49; 95% CI, 1.37-4.62; P = .003). The asymptomatic responders had favorable outcomes compared to the symptomatic nonresponders (2-year OS rates: 83.6% and 35.9%, respectively), while the symptomatic responders had similar outcomes to the asymptomatic nonresponders. The median postprogression survival differed significantly: 10.2 months for the symptomatic patients and 15.9 months for the asymptomatic patients (HR, 2.29; 95% CI, 1.25-4.29, P = .008). The objective response rates and patient toxicity profiles were similar irrespective of the severity of baseline symptoms.
CONCLUSION


Baseline symptoms were associated with worse OS but not with impaired treatment efficacy or more frequent AEs in mCRC patients treated with cetuximab in addition to chemotherapy.",2020,"The asymptomatic responders had favorable outcomes compared to the symptomatic nonresponders (2-year OS rates: 83.6% and 35.9%, respectively), while the symptomatic responders had similar outcomes to the asymptomatic nonresponders.","['unresectable metastatic colorectal cancer', '137 mCRC patients', 'metastatic colorectal cancer (mCRC) patients treated with the first-line cetuximab and standard chemotherapy']","['cetuximab plus chemotherapy', 'cetuximab']","['quality of life (QOL), treatment efficacy, and adverse events (AEs', 'median postprogression survival', 'objective response rates and patient toxicity profiles', 'overall survival (OS']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",137.0,0.112458,"The asymptomatic responders had favorable outcomes compared to the symptomatic nonresponders (2-year OS rates: 83.6% and 35.9%, respectively), while the symptomatic responders had similar outcomes to the asymptomatic nonresponders.","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ooki', 'Affiliation': 'Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shigeyoshi', 'Initials': 'S', 'LastName': 'Iwamoto', 'Affiliation': 'Cancer Center, Aichi Medical University, Nagakute, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tanioka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kataoka', 'Affiliation': 'Department of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kagawa', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.'}, {'ForeName': 'Tatsushi', 'Initials': 'T', 'LastName': 'Shingai', 'Affiliation': 'Department of Surgery, Osaka Saiseikai Senri Hospital, Suita, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Surgery, Shikoku Central Hospital, Shikokuchuo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Miyake', 'Affiliation': 'Department of Surgery, Osaka Minato Central Hospital, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Suto', 'Affiliation': 'Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Yojiro', 'Initials': 'Y', 'LastName': 'Hashiguchi', 'Affiliation': 'Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taichi', 'Initials': 'T', 'LastName': 'Yabuno', 'Affiliation': ""Department of Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Tokai Central Hospital, Kakamigahara, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Kagawa University, Kita, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",Cancer medicine,['10.1002/cam4.2826']
160,32090502,Cost-effectiveness of the Collaborative Care to Preserve Performance in Cancer (COPE) trial tele-rehabilitation interventions for patients with advanced cancers.,"PURPOSE


The purpose of this analysis was to determine the cost-effectiveness of a Collaborative Care Model (CCM)-based, centralized telecare approach to delivering rehabilitation services to late-stage cancer patients experiencing functional limitations.
METHODS


Data for this analysis came from the Collaborative Care to Preserve Performance in Cancer (COPE) trial, a randomized control trial of 516 patients assigned to: (a) a control group (arm A), (b) tele-rehabilitation (arm B), and (c) tele-rehabilitation plus pharmacological pain management (arm C). Patient quality of life was measured using the EQ-5D-3L at baseline, 3-month, and 6-month follow-up. Direct intervention costs were measured from the experience of the trial. Participants' hospitalization data were obtained from their medical records, and costs associated with these encounters were estimated from unit cost data and hospital-associated utilization information found in the literature. A secondary analysis of total utilization costs was conducted for the subset of COPE trial patients for whom comprehensive cost capture was possible.
RESULTS


In the intervention-only model, tele-rehabilitation (arm B) was found to be the dominant strategy, with an incremental cost-effectiveness ratio (ICER) of $15 494/QALY. At the $100 000 willingness-to-pay threshold, this tele-rehabilitation was the cost-effective strategy in 95.4% of simulations. It was found to be cost saving compared to enhanced usual care once the downstream hospitalization costs were taken into account. In the total cost analysis, total inpatient hospitalization costs were significantly lower in both tele-rehabilitation (arm B) and tele-rehabilitation plus pain management (arm C) compared to control (arm A), (P = .048).
CONCLUSION


The delivery of a CCM-based, centralized tele-rehabilitation intervention to patients with advanced stage cancer is highly cost-effective. Clinicians and care teams working with this vulnerable population should consider incorporating such interventions into their patient care plans.",2020,"In the total cost analysis, total inpatient hospitalization costs were significantly lower in both tele-rehabilitation (arm B) and tele-rehabilitation plus pain management (arm C) compared to control (arm A), (P = .048).
","['516 patients assigned to: (a) a', 'patients with advanced cancers', 'late-stage cancer patients experiencing functional limitations', 'patients with advanced stage cancer']","['control group (arm A), (b) tele-rehabilitation (arm B), and (c) tele-rehabilitation plus pharmacological pain management (arm C', 'Collaborative Care Model (CCM)-based, centralized telecare approach', 'Collaborative Care']","['Patient quality of life', 'cost saving', 'cost-effectiveness', 'total utilization costs', 'total cost analysis, total inpatient hospitalization costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",516.0,0.0338662,"In the total cost analysis, total inpatient hospitalization costs were significantly lower in both tele-rehabilitation (arm B) and tele-rehabilitation plus pain management (arm C) compared to control (arm A), (P = .048).
","[{'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'Longacre', 'Affiliation': 'Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Nyman', 'Affiliation': 'Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Sue L', 'Initials': 'SL', 'LastName': 'Visscher', 'Affiliation': 'Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Bijan J', 'Initials': 'BJ', 'LastName': 'Borah', 'Affiliation': 'Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cheville', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, USA.'}]",Cancer medicine,['10.1002/cam4.2837']
161,31981648,Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video).,"BACKGROUND AND AIMS


Compared with conventional endoscopy, magnetically controlled capsule gastroscopy (MCCG) can be further optimized in gastric examination time and complete visualization of upper GI (UGI) mucosa. The second-generation MCCG (MCCG-2) was developed with higher image resolution and adaptive frame rate, and we aimed to evaluate its clinical availability for UGI examination in this study.
METHODS


Consecutive patients undergoing MCCG examination between May to June 2019 were prospectively enrolled and randomized to swallow the first-generation MCCG (MCCG-1) or MCCG-2 in a 1:1 ratio. The main outcomes included visualization of the esophagus and duodenum, operation-related parameters, image quality, maneuverability, detection of lesions, and safety evaluation.
RESULTS


Eighty patients were enrolled. In the MCCG-2 group, frames captured for esophageal mucosa and Z-line were 171.00 and 2.00, significantly increased from those in the MCCG-1 group (97.00 [P = .002] and .00 [P = .028], respectively). The gastric examination time was shortened from 7.78 ± .97 minutes to 5.27 ± .74 minutes (P < .001), with the total running time of the capsule extended from 702.83 minutes to 1001.99 minutes (P < .001). MCCG-2 also greatly improved the image quality (P < .001) and maneuverability (P < .01). No statistical difference existed in the detection of lesions between the 2 groups, and no adverse events occurred.
CONCLUSIONS


MCCG-2 showed better performance in mucosal visualization, examination duration, and maneuverability, making better diagnosis of UGI diseases a possibility. (Clinical trial registration number: NCT03977935.).",2020,MCCG-2 also greatly improved the image quality (P<0.001) and maneuverability (P<0.01).,"['Eighty patients were enrolled', 'Consecutive patients undergoing MCCG examination between May to June 2019']","['swallow the first-generation MCCG (MCCG-1) or MCCG-2', 'conventional endoscopy, magnetically controlled capsule gastroscopy (MCCG', 'Second-generation magnetically controlled capsule gastroscopy']","['image resolution and frame rate', 'visualization of the esophagus and duodenum, operation related parameters, image quality, maneuverability, detection of lesions, as well as safety evaluation', 'gastric examination time', 'image quality', 'detection of lesions', 'performance in mucosal visualization, examination duration and maneuverability', 'esophageal mucosa and Z-line', 'total running time of capsule']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0227176', 'cui_str': 'Esophagus Mucosa'}, {'cui': 'C0230719', 'cui_str': 'Z line (cell structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]",80.0,0.129374,MCCG-2 also greatly improved the image quality (P<0.001) and maneuverability (P<0.01).,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yang-Yang', 'Initials': 'YY', 'LastName': 'Qian', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Yuan-Chen', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Jia-Hui', 'Initials': 'JH', 'LastName': 'Zhu', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wen-Bin', 'Initials': 'WB', 'LastName': 'Zou', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Naval Medical University, Shanghai, China.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.01.027']
162,31375753,A Randomised Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction in Improving Activity of Non-Alcoholic Fatty Liver Disease.,"Currently, there is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. The current study aimed to determine the effectiveness and adherence of eight weeks of modified alternate-day calorie restriction (MACR) in the control of NAFLD activity. This was a randomized controlled trial with MACR as the intervention and normal habitual diet as control. The outcome measures were body mass index (BMI), blood lipids, fasting blood sugar (FBS), liver enzymes (ALT and AST), and ultrasonographic measurements of liver steatosis and shear wave elastography (SWE). Per-protocol (PP) and intention-to-treat (ITT) analysis were performed within and between-groups with P < 0.05 as significant. 43 individuals with NAFLD satisfied study entry criteria, 33 were randomized to MACR and 10 to control group, and, 30 from MACR and 9 from control group completed PP. In between-group analysis of MACR vs. control, BMI were reduced in PP (P = 0.02) and ITT (P = 0.04). Only ALT was reduced in between-group analysis of MACR vs. control, both PP and ITT (P = 0.02 and 0.04 respectively). No reductions in all lipid parameters and FBS were found in between-group analyses (PP and ITT, all P > 0.22). Both liver steatosis grades and fibrosis (SWE) scores were reduced in between-group analyses of MACR vs. controls (PP and ITT, all P < 0.01). Adherence level remained between 75-83% throughout the study. As conclusion, 8 weeks of MACR protocol appears more effective than usual habitual diet in the control of NAFLD activity and with good adherence rate.",2019,"Both liver steatosis grades and fibrosis (SWE) scores were reduced in between-group analyses of MACR vs. controls (PP and ITT, all P < 0.01).","['Non-Alcoholic Fatty Liver Disease', '43 individuals with NAFLD satisfied study entry criteria, 33 were randomized to']","['modified alternate-day calorie restriction (MACR', 'MACR', 'Modified Alternate-day Calorie Restriction']","['liver steatosis grades and fibrosis (SWE) scores', 'body mass index (BMI), blood lipids, fasting blood sugar (FBS), liver enzymes (ALT and AST), and ultrasonographic measurements of liver steatosis and shear wave elastography (SWE', 'Per-protocol (PP) and intention-to-treat (ITT) analysis', 'Adherence level', 'lipid parameters and FBS']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",43.0,0.0659386,"Both liver steatosis grades and fibrosis (SWE) scores were reduced in between-group analyses of MACR vs. controls (PP and ITT, all P < 0.01).","[{'ForeName': 'Muhammad Izzad', 'Initials': 'MI', 'LastName': 'Johari', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairiah', 'Initials': 'K', 'LastName': 'Yusoff', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Juhara', 'Initials': 'J', 'LastName': 'Haron', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Chandran', 'Initials': 'C', 'LastName': 'Nadarajan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Khairun Nisah', 'Initials': 'KN', 'LastName': 'Ibrahim', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Muhammad Ilham Abdul', 'Initials': 'MIA', 'LastName': 'Hafidz', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Bee Eng', 'Initials': 'BE', 'LastName': 'Chua', 'Affiliation': 'Hospital Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Nurhazwani', 'Initials': 'N', 'LastName': 'Hamid', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Wan Nor', 'Initials': 'WN', 'LastName': 'Arifin', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia. yylee@usm.my.'}]",Scientific reports,['10.1038/s41598-019-47763-8']
163,31826326,"The effect of frequent hemodialysis on matrix metalloproteinases, their tissue inhibitors, and FGF23: Implications for blood pressure and left ventricular mass modification in the Frequent Hemodialysis Network trials.","BACKGROUND


Frequent hemodialysis modifies serum phosphorus, blood pressure, and left ventricular mass (LVM). We ascertained whether frequent hemodialysis is associated with specific changes in biomarker profile among patients enrolled in the frequent hemodialysis network (FHN) trials.
METHODS


This was a post hoc analysis of biomarkers among patients enrolled to the FHN trials. In particular, we hypothesized that frequent hemodialysis is associated with changes in a specific set of biomarkers which are linked with changes in blood pressure or LVM.
RESULTS


Among 332 randomized patients, 243 had biomarker data available. Of these, 124 patients were assigned to 3-times-a-week hemodialysis (94 [Daily Trial] and 30 [Nocturnal Trial]) and 119 patients were assigned to 6-times-a-week hemodialysis (87 [Daily Trial] and 32 [Nocturnal Trial]). Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels. The fall in phosphate was associated with changes in FGF23 (r = 0.48, P < 0.001) [Daily Trial] and (r = 0.55, P < 0.001) [Nocturnal Trial]) and tended to be associated with changes in systolic blood pressure (r = 0.18, P = 0.057) [Daily Trial] and (r = 0.31, P = 0.04) [Nocturnal Trial]. Within the Daily Trial, changes in MMP2 (r = 0.20, P = 0.034) were associated with changes in LVM. In the Nocturnal Trial, changes in TIMP-1 (r = 0.37, P = 0.029) and MMP 9 (r = -0.38, P = 0.01) were associated with LVM changes. MMP2 changes were associated with changes in systolic blood pressure.
CONCLUSIONS


Reduction of serum phosphate by frequent hemodialysis may modulate FGF23 levels and systolic blood pressure. Markers of matrix turnover are associated with LVM changes. Frequent hemodialysis may affect pathological mediators of chronic kidney disease-mineral bone-metabolism disorder.",2020,"Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels.","['patients enrolled in the frequent hemodialysis network (FHN) trials', '332 randomized patients, 243 had biomarker data available', '124 patients were assigned to 3-times-a-week hemodialysis (94 [Daily Trial] and 30 [Nocturnal Trial]) and 119 patients were assigned to', 'patients enrolled to the FHN trials']",['6-times-a-week hemodialysis'],"['FGF23 levels and systolic blood pressure', 'systolic blood pressure', 'blood pressure or LVM', 'MMP2', 'FGF23', 'Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels', 'TIMP-1', 'serum phosphorus, blood pressure, and left ventricular mass (LVM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}]","[{'cui': 'C0585299', 'cui_str': '6x/wk'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0145946', 'cui_str': 'Tissue Inhibitor of Metalloproteinase-2'}, {'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}]",332.0,0.0248733,"Frequent hemodialysis lowered phosphate, blood pressures, LVM, log fibroblast growth factor (FGF)23, and tissue inhibitors of metalloproteinase (TIMP)-2 levels.","[{'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Kaysen', 'Affiliation': 'University of California Davis, Davis, California, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Beck', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Minwei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Joan C', 'Initials': 'JC', 'LastName': 'Lo', 'Affiliation': 'Kaiser Permanente Northern California, Oakland, California, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Kliger', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12807']
164,32200138,Osimertinib in T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study).,"OBJECTIVES


In non-small cell lung cancer patients with acquired resistance to first- or second-generation EGFR-TKIs, osimertinib is approved in the presence of the T790 M resistance mutation. We assessed the efficacy of osimertinib in both T790M-positive and T790M-negative patients.
MATERIALS AND METHODS


The TREM-study is an investigator-initiated, multi-centre, single-arm, phase 2 clinical trial conducted in five Northern European countries. Patients with progression on at least one previous EGFR-TKI were assigned to treatment with 80 mg of osimertinib daily until radiological progression or death. Patients were included regardless of the presence of T790 M. The primary endpoint was objective response rate (ORR).
RESULTS


Of 199 included patients, 120 (60 %) were T790M-positive, 52 (26 %) were T790M-negative and 27 (14 %) had unknown T790M-status. 24 % had brain metastases and 15 % had an ECOG performance status of 2. Overall ORR was 48 % (95 % CI, 41 %-55 %), 60 % (51 %-69 %) for T790M-positive patients and 28 % (15 %-41 %) for T790M-negative patients, p < 0.001. ORR for patients with co-occurring del19 vs L858R was 61 % vs 32 %, p = 0.001. Duration of response was similar between the T790M-positive and -negative groups (11.8 vs 10.7 months, p = 0.229). Overall median progression-free survival (PFS) was 8.9 months (95 % CI, 7.4-10.5), and 10.8 vs 5.1 months for T790M-positive vs -negative patients (HR 0.62, p = 0.007). Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3). For T790M-positive vs -negative median OS was 22.5 vs 13.4 months, (HR 0.55, p = 0.002).
CONCLUSIONS


This study confirms the efficacy of osimertinib for T790M-positive patients. There was also clinically significant activity of osimertinib in a proportion of T790M-negative patients.
CLINICAL TRIAL REGISTRATION


This trial is registered with ClinicalTrials.gov (NCT02504346).",2020,"Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3).","['Of 199 included patients, 120 (60 %) were T790M-positive, 52 (26 %) were T790M-negative and 27 (14 %) had unknown T790M-status', 'Patients with progression on at least one previous EGFR-TKI', 'T790M-positive patients', 'non-small cell lung cancer patients with acquired resistance to first- or second-generation EGFR-TKIs, osimertinib is approved in the presence of the T790 M resistance mutation', 'Patients were included regardless of the presence of T790 M', 'T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study', 'T790M-positive and T790M-negative patients']",[],"['Duration of response', 'Median overall survival (OS', 'objective response rate (ORR', 'ORR', 'Overall ORR', 'ECOG performance status', 'brain metastases', 'Overall median progression-free survival (PFS']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",199.0,0.302362,"Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3).","[{'ForeName': 'Inger Johanne Zwicky', 'Initials': 'IJZ', 'LastName': 'Eide', 'Affiliation': 'Vestre Viken Hospital Trust, Drammen, Norway; Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Electronic address: ingei@vestreviken.no.'}, {'ForeName': 'Åslaug', 'Initials': 'Å', 'LastName': 'Helland', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Departement of Oncology, Oslo University Hospital, Oslo, Norway; University of Oslo, Department of Clinical Medicine, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ekman', 'Affiliation': 'Thoracic Oncology Center, Karolinska University Hospital/Departement of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karin Holmskov', 'Initials': 'KH', 'LastName': 'Hansen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Cicenas', 'Affiliation': 'National Cancer Institute, VU MF, Vilnius, Lithuania.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Koivunen', 'Affiliation': 'Oulu University Hospital, University of Oulu, MRC Oulu, Oulu, Finland.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': ""Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Vestre Viken Hospital Trust, Drammen, Norway; Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.03.009']
165,31313402,Opioid use and dropout from extended-release naltrexone in a controlled trial: implications for mechanism.,"BACKGROUND AND AIMS


Extended-release formulations of naltrexone have emerged as effective treatment options for opioid use disorder. This post-hoc analysis examined the temporal relationship between episodes of opioid use and subsequent dropout in a placebo-controlled trial of extended-release injection naltrexone (XR-NTX) to draw inferences about the mechanism by which extended blockade of opioid receptors translates into clinical effectiveness.
DESIGN


This was a 24-week multiple-site, double-blind, randomized trial of monthly XR-NTX versus placebo injections. We analyzed time to dropout from treatment using survival analysis with an extended Cox model as a function of treatment (XR-NTX versus placebo) and with weekly urine drug test (UDT) results for opioids at each week as a time-dependent covariate.
SETTING


Thirteen addiction treatment programs in Russia, 2008-09.
PARTICIPANTS


A total of 250 adults with opioid use disorder who had completed in-patient detoxification.
INTERVENTION


XR-NTX injection or placebo injection every 4 weeks with weekly clinic visits and biweekly counseling.
MEASUREMENTS


Urine toxicology for opioids measured weekly and week of dropout from treatment.
FINDINGS


The Cox model yielded a significant interaction of time-dependent urine toxicology by treatment (P = 0.024). Among patients receiving placebo, a positive UDT in a given week increased the risk for dropout from treatment in the subsequent week [hazard ratio (HR) = 6.25; 95% confidence interval (CI) = 3.6-10.0], whereas among patients receiving XR-NTX, a positive UDT result showed no significant effect on risk for dropout (HR = 1.67; 95% CI = 0.6-4.5). The proportion of patients who completed all 24 weeks without any positive UDT result was 31% on XR-NTX compared with 20% on placebo (P = 0.051).
CONCLUSIONS


Extended-release injection naltrexone was effective at reducing the risk of dropout from opioid use disorder treatment after an episode of opioid use. Just under a third of patients (31%) on XR-NTX had no opioid-positive urine tests across the trial, but the hypothesis that this would differ from placebo (20%) was not confirmed.",2020,The Cox model yielded a significant interaction of time-dependent urine toxicology by treatment (P = 0.024).,"['Thirteen addiction treatment programs in Russia, 2008-09', 'A total of 250 adults with opioid use disorder who had completed in-patient detoxification']","['naltrexone', 'XR-NTX injection or placebo', 'naltrexone (XR-NTX', 'placebo', 'NTX versus placebo', 'XR-NTX', 'placebo injections']",['risk for dropout'],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}]",13.0,0.318403,The Cox model yielded a significant interaction of time-dependent urine toxicology by treatment (P = 0.024).,"[{'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bisaga', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Krupitsky', 'Affiliation': 'St Petersburg Pavlov State Medical University, St Petersburg, Russia.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Bernard L', 'Initials': 'BL', 'LastName': 'Silverman', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Akerman', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sullivan', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14735']
166,31972610,Effects of High-Fiber Diets and Macronutrient Substitution on Bloating: Findings From the OmniHeart Trial.,"OBJECTIVES


To examine the effects of high-fiber, isocaloric, macronutrient substitutions on bloating.
METHODS


The OmniHeart study is a randomized 3-period crossover feeding trial conducted from April 2003 to June 2005. Participants were provided 3 isocaloric versions of high-fiber (∼30 g per 2,100 kcal) diet, each different in carbohydrate, protein, and unsaturated fat composition. Each feeding period lasted for 6 weeks with a 2- to 4-week washout period between diets. Participants reported the presence and severity of bloating at baseline (participants were eating their own diet) and at the end of each feeding period.
RESULTS


One hundred sixty-four participants were included in the analysis (mean age: 53.1 years; 45% women; 55% black). The prevalence of bloating at baseline and at the end of the carbohydrate-rich, protein-rich, and unsaturated fat-rich diet period was 18%, 24%, 33%, and 30%, respectively. Compared with baseline, the relative risk of bloating for the carbohydrate-rich, protein-rich, and unsaturated fat-rich high-fiber diet was 1.34 (95% confidence interval [CI]: 0.93, 1.92), 1.78 (95% CI: 1.32, 2.40), and 1.63 (95% CI: 1.17, 2.26), respectively. The protein-rich diet increased the risk of bloating more than the carbohydrate-rich diet (relative risk = 1.40; 95% CI: 1.03, 1.88). Bloating did not significantly vary between protein-rich vs unsaturated fat-rich or unsaturated fat-rich vs carbohydrate-rich diets. Black participants compared with non-black participants had a higher risk of bloating after all 3 versions of the high-fiber OmniHeart diet (P-value for interaction = 0.012).
DISCUSSION


Substitution of protein with carbohydrate may be an effective strategy to decrease bloating among individuals experiencing gastrointestinal bloating from a high-fiber diet.",2020,"The protein-rich diet increased the risk of bloating more than the carbohydrate-rich diet (relative risk = 1.40; 95% CI: 1.03, 1.88).","['April 2003 to June 2005', 'One hundred sixty-four participants were included in the analysis (mean age: 53.1 years; 45% women; 55% black']","['high-fiber, isocaloric, macronutrient substitutions', 'High-Fiber Diets and Macronutrient Substitution']","['prevalence of bloating', 'presence and severity of bloating', 'relative risk of bloating', 'risk of bloating', 'bloating', 'Bloating']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0301568', 'cui_str': 'High residue diet (finding)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",164.0,0.0323859,"The protein-rich diet increased the risk of bloating more than the carbohydrate-rich diet (relative risk = 1.40; 95% CI: 1.03, 1.88).","[{'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Pankaj Jay', 'Initials': 'PJ', 'LastName': 'Pasricha', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000122']
167,31915046,Initiate Danhong Injection before or after percutaneous coronary intervention for microvascular obstruction in ST-elevation myocardial infarction (DIRECTION): study protocol for a randomized controlled trial.,"BACKGROUND


No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong Injection. However, evidence of a rigorously designed verification study is still lacking, and the intervention timing of Danhong Injection is uncertain.
METHODS


The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind study. A total of 336 patients with STEMI receiving percutaneous coronary intervention (PCI) will be randomly assigned to conventional treatment, the preoperative Danhong Injection, or the postoperative Danhong Injection. The primary outcome is rate of ST-segment resolution (STR) ≥ 70% at 90 min after PCI. The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin I (cTnI) and for creatine kinase MB. The major adverse cardiovascular events and hospital readmission events will be recorded. Health quality will be assessed with the 12-item Short Form Health Survey. The safety outcomes include bleeding events, adverse events, and abnormal changes in routine blood tests. Psychological status and dietary patterns will be evaluated using Hamilton Depression Rating Scale and Food Frequency Questionnaire as the relevant indicators.
DISCUSSION


This trial will evaluate the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention to prevent MVO in patients with STEMI.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900021440. Registered on February 21, 2019.",2020,"The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin","['336 patients with STEMI receiving percutaneous coronary intervention (PCI', 'patients with STEMI', 'patients with ST-elevation myocardial infarction (STEMI']","['Danhong Injection', 'percutaneous coronary intervention']","['rate of ST-segment resolution (STR)\u2009≥\u200970% at 90\u2009min after PCI', 'Hamilton Depression Rating Scale and Food Frequency Questionnaire', 'degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin', 'bleeding events, adverse events, and abnormal changes in routine blood tests', 'major adverse cardiovascular events and hospital readmission events', 'Health quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C2715773', 'cui_str': 'danhong'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C2242501', 'cui_str': 'N-terminal prohormone brain natriuretic peptide'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",336.0,0.115327,"The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Zhaofeng', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Jiayuan', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Chengyu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Tianmai', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Songjie', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China. lijingzhang@263.net.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China. sasliu@yeah.net.'}, {'ForeName': 'Hongcai', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China. shanghongcai@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3947-6']
168,32300910,A Randomized Controlled Trial of Functional Communication Training via Telehealth for Young Children with Autism Spectrum Disorder.,"Many children with autism spectrum disorder (ASD) have problem behaviors that interfere with learning and social interaction. This randomized controlled trial compared treatment with functional communication training (FCT) to ""treatment as usual"" for young children with ASD (n = 38, ages 21-84 months). FCT was conducted by parents with training and real-time coaching provided by behavioral consultants using telehealth. FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period. Social communication and task completion also improved. For children with ASD and moderate to severe behavior problems, parent-implemented FCT using telehealth significantly reduced problem behavior while ongoing interventions typically did not.",2020,"FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period.","['young children with ASD (n\u2009=\u200938, ages 21-84\xa0months', 'Young Children with Autism Spectrum Disorder', 'children with autism spectrum disorder (ASD']","['Functional Communication Training via Telehealth', 'FCT', 'functional communication training (FCT']",['Social communication and task completion'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4708134', 'cui_str': 'Functional communication training'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0709193,"FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving ""treatment as usual"" during a 12-week period.","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lindgren', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA. scott-lindgren@uiowa.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wacker', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schieltz', 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Suess', 'Affiliation': 'Chatter Pediatric Therapy, Williston, ND, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Pelzel', 'Affiliation': 'Department of Psychiatry, University of Iowa College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Kopelman', 'Affiliation': 'Department of Psychiatry, University of Iowa College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Telehealth Behavioral Consultation Services, Sahuarita, AZ, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Romani', 'Affiliation': ""Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Stead Family Department of Pediatrics, University of Iowa College of Medicine, 100 Hawkins Drive, Iowa City, IA, 52242, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04451-1']
169,32302640,Randomized controlled trial comparing glass fiber posts and cast metal posts.,"OBJECTIVE


This study aimed to assess the survival and success of glass fiber posts compared to cast metal posts in teeth without ferrule.
MATERIAL AND METHODS


An equivalency, prospective, double-blind (patient and outcome evaluator) randomized controlled trial (RCT) with parallel groups was designed to compare the clinical performance of cast metal and glass fiber posts cemented in endodontically treated teeth without ferrule (NCT01461239). Teeth were randomly allocated to the glass fiber or cast-metal post groups. All teeth were restored with single metal-ceramic crowns. Kaplan-Meier analysis with the log-rank test was used to test the success and survival between glass fiber and cast metal posts considering a cut-off value of P = 0.05. The annual failure rates were calculated considering the survival data for all restorations and separated by type of post after five years.
RESULTS


A hundred and nineteen patients and 183 posts (72 cast metal posts and 111 glass fiber posts) were analyzed. The median follow-up was 62 months (IQR 37-81). The log-rank test for success (P = 0.26) and survival (P = 0.63) analyses did not present statistically significant differences. The AFR of both posts after 5 years was 1.5%. Considering the posts separately and after 5 years, cast metal posts presented AFR of 1.2% and glass fiber posts AFR of 1.7%. Most failures were in posterior teeth (16/23), 10 failures were classified as root fractures and 5 as post debonding. The follow-up rate was 95.3%.
CONCLUSIONS


Glass fiber and cast metal posts showed good and similar clinical performance.
CLINICAL SIGNIFICANCE


Results of this randomized controlled trial can help dentists to answer how the best technique to rehabilitate endodontically treated teeth with no remaining coronal wall.",2020,The log-rank test for success (P = 0.26) and survival (P = 0.63) analyses did not present statistically significant differences.,['A hundred and nineteen patients and 183 posts (72 cast metal posts and 111 glass fiber posts'],"['glass fiber or cast-metal post groups', 'glass fiber posts and cast metal posts', 'cast metal posts', 'glass fiber posts']","['survival and success', 'log-rank test for success', 'annual failure rates', 'survival']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439873', 'cui_str': 'Cast metal'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]","[{'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0439873', 'cui_str': 'Cast metal'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.152641,The log-rank test for success (P = 0.26) and survival (P = 0.63) analyses did not present statistically significant differences.,"[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Sarkis-Onofre', 'Affiliation': 'Graduate Program in Dentistry, Meridional Faculty (IMED), 304 Senador Pinheiro Machado Street, 99070-220, Passo Fundo, Brazil; Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Amaral Pinheiro', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Victório', 'Initials': 'V', 'LastName': 'Poletto-Neto', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'César Dalmolin', 'Initials': 'CD', 'LastName': 'Bergoli', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Pereira-Cenci', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, 457 Gonçalves Chaves Street, Pelotas, Brazil. Electronic address: Tatiana.cenci@ufpel.tche.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103334']
170,32302659,Dextran- Versus Crystalloid-Based Prime in Cardiac Surgery: A Prospective Randomized Pilot Study.,"BACKGROUND


The optimum priming fluid for the cardiopulmonary bypass (CPB) circuit is still debated. We compared a new hyperoncotic priming solution containing dextran 40, which has an electrolyte composition that mimics extracellular fluid, with a standard crystalloid-based prime.
METHODS


Eighty cardiac surgery patients were included in this double-blind, randomized, single-center study. Patients were randomized to either a dextran-based prime or a crystalloid prime containing Ringer's acetate and mannitol. The primary end point was colloid oncotic pressure in serum during CPB. Secondary end points included fluid balance, bleeding and transfusion requirements, pulmonary function, hemolysis, systemic inflammation, and markers of renal, hepatic, myocardial, and brain injury. Blood samples were collected before, during, and after CPB.
RESULTS


Colloid oncotic pressure was higher in the dextran group than in the crystalloid prime group during CPB (18.8 ± 2.9 versus 16.4 ± 2.9 mm Hg; P < .001) and 10 minutes after CPB (19.2 ± 2.7 versus 16.8 ± 2.9 mm Hg; P < .001). Patients in the dextran group required less intravenous fluid during CPB (1090 ± 499 versus 1437 ± 543 mL; P = .004) and net fluid balance was less positive 12 hours after surgery (1431 ± 741 versus 1901 ± 922 mL; P = .014). Plasma-free hemoglobin was significantly lower in the dextran group 2 hours after CPB (0.18 ± 0.11 versus 0.41 ± 0.33; P = .001). There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between groups at any time point.
CONCLUSIONS


Our results suggest that a hyperoncotic dextran-based priming solution preserves intraoperative colloid oncotic pressure compared with crystalloid prime. Larger studies with clinically valid end points are necessary to evaluate hyperoncotic prime solutions further.",2020,"There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between the groups at any time point.
","['cardiac surgery', 'Eighty cardiac surgery patients']","['Dextran- versus crystalloid-based prime', 'dextran', 'hyperoncotic dextran-based priming solution', 'dextran-based prime or a crystalloid prime containing Ringer acetate and mannitol']","['fluid balance, bleeding and transfusion requirements, pulmonary function, hemolysis, systemic inflammation, and markers of renal, hepatic, myocardial, and brain injury', 'net fluid balance', 'colloid oncotic pressure (COP) in serum during CPB', 'COP', 'CPB', 'intravenous fluid during CPB', 'Plasma free hemoglobin', 'intraoperative COP', 'bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086140', 'cui_str': 'Dextran'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0311418', 'cui_str': 'Oncotic pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0948712', 'cui_str': 'Free plasma haemoglobin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",80.0,0.332131,"There were no significant differences in bleeding, transfusion requirements, organ function, systemic inflammation, or brain and myocardial injury markers between the groups at any time point.
","[{'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Barbu', 'Affiliation': 'Department of Cardiology, Blekinge Hospital, Karlskrona, Sweden; Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Kolsrud', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Cardiothoracic Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Anesthesiology and Intensive Care, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Dellgren', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Björk', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorén', 'Affiliation': 'Department of Cardiothoracic Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Hansson', 'Affiliation': 'Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jeppsson', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: anders.jeppsson@vgregion.se.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.031']
171,29178434,Demonstration of an anti-hyperalgesic effect of a novel pan-Trk inhibitor PF-06273340 in a battery of human evoked pain models.,"AIM


Inhibitors of nerve growth factor (NGF) reduce pain in several chronic pain indications. NGF signals through tyrosine kinase receptors of the tropomyosin-related kinase (Trk) family and the unrelated p75 receptor. PF-06273340 is a small molecule inhibitor of Trks A, B and C that reduces pain in nonclinical models, and the present study aimed to investigate the pharmacodynamics of this first-in-class molecule in humans.
METHODS


A randomized, double-blind, single-dose, placebo- and active-controlled five-period crossover study was conducted in healthy human subjects (NCT02260947). Subjects received five treatments: PF-06273340 50 mg, PF-06273340 400 mg, pregabalin 300 mg, ibuprofen 600 mg and placebo. The five primary endpoints were the pain detection threshold for the thermal pain tests and the pain tolerance threshold for the cold pressor, electrical stair and pressure pain tests. The trial had predefined decision rules based on 95% confidence that the PF-06273340 effect was better than that of placebo.
RESULTS


Twenty subjects entered the study, with 18 completing all five periods. The high dose of PF-06273340 met the decision rules on the ultraviolet (UV) B skin thermal pain endpoint [least squares (LS) mean vs. placebo: 1.13, 95% confidence interval: 0.64-1.61], but not on the other four primary endpoints. The low dose did not meet the decision criteria for any of the five primary endpoints. Pregabalin (cold pressor and electrical stair tests) and ibuprofen (UVB thermal pain) showed significant analgesic effects on expected endpoints.
CONCLUSIONS


The study demonstrated, for the first time, the translation of nonclinical effects into man in an inflammatory pain analgesic pharmacodynamic endpoint using a pan-Trk inhibitor.",2018,"The five primary endpoints were the pain detection threshold for the thermal pain tests and the pain tolerance threshold for the cold pressor, electrical stair and pressure pain tests.","['human evoked pain models', 'healthy human subjects (NCT02260947', 'Twenty subjects entered the study, with 18 completing all five periods']","['nerve growth factor (NGF', 'Pregabalin (cold pressor and electrical stair tests) and ibuprofen (UVB thermal pain', 'novel pan-Trk inhibitor PF-06273340', 'placebo', 'PF-06273340 50\xa0mg, PF-06273340 400\xa0mg, pregabalin 300\xa0mg, ibuprofen 600\xa0mg and placebo']","['pain detection threshold for the thermal pain tests and the pain tolerance threshold for the cold pressor, electrical stair and pressure pain tests']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4507444', 'cui_str': 'PF-06273340'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1658879', 'cui_str': 'pregabalin 300 MG'}, {'cui': 'C1600132', 'cui_str': 'Ibuprofen 600 MG [Ibu]'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.291704,"The five primary endpoints were the pain detection threshold for the thermal pain tests and the pain tolerance threshold for the cold pressor, electrical stair and pressure pain tests.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Loudon', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Siebenga', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef, 8,2333 CL, Leiden, the Netherlands.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': 'Gorman', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Gore', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Pinky', 'Initials': 'P', 'LastName': 'Dua', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'van Amerongen', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef, 8,2333 CL, Leiden, the Netherlands.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Hay', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef, 8,2333 CL, Leiden, the Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef, 8,2333 CL, Leiden, the Netherlands.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Butt', 'Affiliation': 'Neuroscience and Pain Research Unit, Pfizer WRD, Cambridge, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.13448']
172,32301412,"Exploring the impact of safety behaviour use on cognitive, psychophysiological, emotional and behavioural responses during a speech task.","BACKGROUND


There is a debate among researchers and clinicians regarding whether the judicious use of safety behaviours (SBs) during exposure therapy is helpful or detrimental. Central to this debate is the premise that SBs may interfere with one's ability to gather disconfirmatory evidence.
AIMS


No study to date has assessed how SB use may impact cognitive mechanisms implicated during an exposure-like task. We investigated multiple cognitive, emotional, psychophysiological and behavioural underpinnings of exposure with and without SBs.
METHOD


Speech anxious participants (n = 111) were randomly assigned to deliver an evaluated speech with or without SBs. Self-reported anxiety ratings and psychophysiological arousal measures were recorded at baseline, in anticipation of the speech, and following the speech. Measures of working memory, ability to gather disconfirmatory evidence, speech duration, objective and subjective speech performance, and speech task acceptability were administered.
RESULTS


There were no differences between conditions on working memory, self-reported anxiety, psychophysiological arousal, ability to gather disconfirmatory evidence, speech duration, or objective and subjective speech performance. All participants were able to gather disconfirmatory evidence. However, condition did influence willingness to deliver future speeches. Our sample was largely female undergraduate students, and we offered only a small number of specific safety behaviours.
CONCLUSIONS


Judicious SB use may not necessarily be detrimental, but clients may believe them to be more helpful than they actually are.",2020,"There were no differences between conditions on working memory, self-reported anxiety, psychophysiological arousal, ability to gather disconfirmatory evidence, speech duration, or objective and subjective speech performance.","['Speech anxious participants (n = 111', 'Our sample was largely female undergraduate students']",['evaluated speech with or without SBs'],"['Self-reported anxiety ratings and psychophysiological arousal measures', 'working memory, self-reported anxiety, psychophysiological arousal, ability to gather disconfirmatory evidence, speech duration, or objective and subjective speech performance', 'working memory, ability to gather disconfirmatory evidence, speech duration, objective and subjective speech performance, and speech task acceptability', 'cognitive, psychophysiological, emotional and behavioural responses']","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",111.0,0.0677306,"There were no differences between conditions on working memory, self-reported anxiety, psychophysiological arousal, ability to gather disconfirmatory evidence, speech duration, or objective and subjective speech performance.","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Tutino', 'Affiliation': 'School of Psychology, University of Ottawa, OttawaCanada.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Ouimet', 'Affiliation': 'School of Psychology, University of Ottawa, OttawaCanada.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Ferguson', 'Affiliation': 'School of Psychology, University of Ottawa, OttawaCanada.'}]",Behavioural and cognitive psychotherapy,['10.1017/S135246582000017X']
173,32303373,Effectiveness of a hand hygiene program to reduce acute gastroenteritis at child care centers: A cluster randomized trial.,"We aimed to assess the effectiveness of an educational and hand hygiene program in daycare centers (DCCs) and homes on acute gastroenteritis (AGE) incidence in children attending DCCs.
METHODS


A randomized, controlled, and open study of 911 children aged 0-3 years attending 24 DCCs in Almería (Spain) with an 8-month follow-up was employed. Two intervention groups of DCCs families performed educational and hand hygiene measures, 1 with soap and water (soap and water group; n = 274), another with hand sanitizer (hand sanitizer group [HSG]; n = 339), and the control group (CG; n = 298) followed usual handwashing procedures. We compared AGE episode rates with Poisson regression model.
RESULTS


seven hundred fourteen AGE episodes were registered, significant differences between HSG and CG children were found during December and January. A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
CONCLUSIONS


This study demonstrated that hand hygiene programs that included hand sanitizer were most effective in the winter months. Further, the largest reduction of AGE episodes occurred in the children that followed hand hygiene programs including hand sanitizer and educational measures for DCC staff, parents, and children, and were vaccinated for rotavirus.",2020,"A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
","['acute gastroenteritis at child care centers', '911 children aged 0-3 years attending 24 DCCs in Almería (Spain) with an 8-month follow-up was employed', 'daycare centers (DCCs) and homes on acute gastroenteritis (AGE) incidence in children attending DCCs']","['DCCs families performed educational and hand hygiene measures, 1 with soap and water (soap and water group; n\u202f=\u202f274), another with hand sanitizer (hand sanitizer group [HSG]; n\u202f=\u202f339), and the control group (CG; n\u202f=\u202f298) followed usual handwashing procedures', 'hand hygiene program', 'educational and hand hygiene program']","['risk of AGE episodes', 'AGE episodes']","[{'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1330330', 'cui_str': 'Hand Antiseptics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",911.0,0.0530918,"A multivariate model was applied and the adjusted incidence rate ratios by rotavirus vaccination found significant differences when children were previously vaccinated, the children in the soap and water group had a higher risk of AGE episodes (incidence rate ratio: 1.28, 95% confidence interval:1.0-1.64), compared with those in the HSG.
","[{'ForeName': 'Ernestina', 'Initials': 'E', 'LastName': 'Azor-Martinez', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain. Electronic address: eazorm@yahoo.es.'}, {'ForeName': 'Llenalia', 'Initials': 'L', 'LastName': 'Garcia-Fernandez', 'Affiliation': 'Deparment of Bioestadistica, SEPLIN, Soluciones Estadísticas, Granada, Spain.'}, {'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Cantarero-Vallejo', 'Affiliation': 'Castilla-La Mancha Deparment of Health, Centro de salud de Illescas, Toledo, Spain.'}, {'ForeName': 'Carmen Pilar', 'Initials': 'CP', 'LastName': 'Jimenez-Lorente', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain.'}, {'ForeName': 'Josep Vicent', 'Initials': 'JV', 'LastName': 'Balaguer-Martinez', 'Affiliation': 'Cantalan Deparment of Health, CAP St Ildefons, Cornellà de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Torres-Alegre', 'Affiliation': 'Andalusian Deparment of Health, Distrito Sanitario de Atención Primaria, Almería, Spain.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Yui-Hifume', 'Affiliation': 'Andalusian Deparment of Pediatrics, Servicio de Pediatría, Hospital Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sanchez-Forte', 'Affiliation': 'Andalusian Deparment of Pediatrics, Servicio de Pediatría, Hospital Torrecárdenas, Almería, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gimenez-Sanchez', 'Affiliation': 'Andalusian Deparment of Pediatrics, Instituto Hispalense de Pediatría, Instituto Balmis de Vacunas, Almeria, Spain.'}]",American journal of infection control,['10.1016/j.ajic.2020.03.011']
174,31093657,Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial.,"AIMS


Circulating high-sensitivity cardiac troponin (hsTn) and soluble ST2 (sST2) reflect myocardial stress in patients with heart failure (HF). Production of cyclic guanosine 3'5' monophosphate (cGMP) in response to activation of natriuretic peptide receptors reduces cardiac afterload and preload. We assessed the effects of sacubitril/valsartan on these biomarkers in patients with reduced ejection fraction and acute decompensated HF (ADHF).
METHODS AND RESULTS


PIONEER-HF was a randomized, double-blind trial of sacubitril/valsartan vs. enalapril in hospitalized patients with ADHF following haemodynamic stabilization. We measured circulating hsTnT, sST2, and urinary cGMP at baseline, 1, 2 (sST2, cGMP), 4, and 8 weeks (n = 694 with all baseline biomarkers). Ratios of geometric means (timepoint/baseline) were determined and compared as a ratio for sacubitril/valsartan vs. enalapril. Compared with enalapril, sacubitril/valsartan led to a significantly greater decline in hsTnT and sST2. This effect emerged as early as 1 week for sST2 and was significant for both at 4 weeks with a 16% greater reduction in hsTnT (P < 0.001) and 9% greater reduction in sST2 (P = 0.0033). Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week). The significant differences between treatment groups for each biomarker were sustained at 8 weeks. In an exploratory multivariable-adjusted analysis of cardiovascular death or HF-rehospitalization, the concentrations of hsTnT, sST2 at week 1 were significantly associated with subsequent outcome.
CONCLUSION


Biomarkers of myocardial stress are elevated in patients with ADHF and associated with outcome. Compared with enalapril, sacubitril/valsartan reduces myocardial injury and haemodynamic stress as reflected by biomarkers, with an onset that is apparent within 1-4 weeks.
CLINICAL TRIALS REGISTRATION


NCT02554890 clinical.trials.gov.",2019,"Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week).","['patients with ADHF', 'patients with acute decompensated heart failure randomized to', 'patients with heart failure (HF', 'patients with reduced ejection fraction and acute decompensated HF (ADHF', 'hospitalized patients with ADHF following haemodynamic stabilization']","['sensitivity cardiac troponin (hsTn) and soluble ST2 (sST2', 'sacubitril/valsartan vs. enalapril', 'enalapril', ""cyclic guanosine 3'5' monophosphate (cGMP"", 'sacubitril-valsartan or enalapril', 'enalapril, sacubitril/valsartan', 'sacubitril/valsartan', 'valsartan vs. enalapril']","['Serial urinary cGMP', 'Cardiovascular biomarkers', 'circulating hsTnT, sST2, and urinary cGMP', 'decline in hsTnT and sST2', 'myocardial injury and haemodynamic stress', 'sST2', 'cardiovascular death or HF-rehospitalization, the concentrations of hsTnT, sST2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0450499', 'cui_str': 'ST2 (body structure)'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0018330', 'cui_str': 'Guanosine'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.203051,"Serial urinary cGMP increased with sacubitril/valsartan compared with enalapril (P < 0.001, 1 week).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': 'TIMI Study Group, 75 Francis Street, Boston, MA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06520-8056, USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, 2400 Pratt St, Durham, NC, USA.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': 'TIMI Study Group, 75 Francis Street, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCague', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rocha', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': 'TIMI Study Group, 75 Francis Street, Boston, MA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz240']
175,32297122,Brief Report: A Job-Based Social Skills Program (JOBSS) for Adults with Autism Spectrum Disorder: A Pilot Randomized Controlled Trial.,"Adults with autism spectrum disorder (ASD) have low employment rates; even those who are employed have low wages and limited hours. This study evaluated the effectiveness of the Job-Based Social Skills (JOBSS) curriculum, a manualized, 15-week, group-delivered intervention for adults with ASD. The intervention aimed to increase social-pragmatic skills necessary to obtain and maintain employment. Twenty-two adults were randomly assigned to either JOBSS intervention or wait-list control groups. Results showed significant improvement in social cognition, as reported by caregivers, among JOBSS group participants compared to wait-list control participants. Forty-five percent of intervention participants gained employment in the six months following participation. This curriculum has potential to improve social skills of adults with ASD, thereby increasing successful employment.",2020,"Results showed significant improvement in social cognition, as reported by caregivers, among JOBSS group participants compared to wait-list control participants.","['Adults with autism spectrum disorder (ASD', 'Twenty-two adults', 'adults with ASD', 'Adults with Autism', 'Spectrum Disorder']","['JOBSS intervention or wait-list control groups', 'Job-Based Social Skills (JOBSS) curriculum', 'Job-Based Social Skills Program (JOBSS']",['social cognition'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",22.0,0.0415679,"Results showed significant improvement in social cognition, as reported by caregivers, among JOBSS group participants compared to wait-list control participants.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Gorenstein', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA. michelle.gorenstein@mssm.edu.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Giserman-Kiss', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA.'}, {'ForeName': 'Elyana', 'Initials': 'E', 'LastName': 'Feldman', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Isenstein', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Donnelly', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA.'}, {'ForeName': 'A Ting', 'Initials': 'AT', 'LastName': 'Wang', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Foss-Feig', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY, USA. jennifer.foss-feig@mssm.edu.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04482-8']
176,32300831,C-reactive protein as marker of post-operative analgesic quality after primary total knee arthroplasty.,"OBJECTIVE


To study the correlation between the level of C-reactive protein (CRP) and the severity of pain in the post-operative period with primary total knee arthroplasty and to conduct a comparative assessment of these indicators with various methods of pain relief. The primary hypothesis of the investigation was that post-operative CRP level is likely to be correlated with the severity of post-operative pain after total knee arthroplasty. The secondary points were the evaluation of CRP and pain syndrome in the groups, as well as the identification of the correlation between the level of CRP and the method of analgesia.
MATERIALS AND METHODS


Peri-operative levels of CRP and pain syndrome (10-point visual analogue scale) studied 160 patients with grade III gonarthrosis who have underwent primary total knee arthroplasty under conditions of subarachnoid anaesthesia in the period from years 2017 to 2019. Depending on the method of post-operative analgesia, patients were divided into five groups: group 1 had only systemic multimodal analgesia (SMA, n = 56), group 2 were treated with the epidural analgesia (EDA, n = 20), group 3 had local high-volume infiltration anaesthesia (LHVIA, n = 20), group 4 were getting LHVIA with a wound catheter (LHVIAc, n = 48), and group 5 had a single blockade of the femoral nerve (FNB, n = 16).
RESULTS


A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = 160, Kendall coefficient τ = 0.230, p = 0,000) and on the first post-operative day (n = 160, τ = 0.21, p = 0.001). The increase in CRP (the difference between pre-operative and post-operative CRP levels) also was positively correlated with the severity of pain in the post-operative period (n = 160, τ = 0.257, p = 0.000 and τ = 0.187, p = 0.001, respectively). CRP level significantly has increased in the post-operative period (p = 0,000). The lowest CRP indicators in the first post-operative day were recorded during the infiltrative anaesthesia (3rd and 4th groups);, the highest were during the administration of SMA group (1st group).
CONCLUSION


The results confirm the correlation between the level of CRP and the severity of pain syndrome in the early post-operative period after total knee arthroplasty, its dependence on the method of analgesia, and allow to use it as a criterion for evaluating of the effectiveness of analgesia.",2020,A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = ,"['Peri-operative levels of CRP and pain syndrome (10-point visual analogue scale) studied 160 patients with grade III gonarthrosis who have underwent primary total knee arthroplasty under conditions of subarachnoid anaesthesia in the period from years 2017 to 2019', 'primary total knee arthroplasty']","['C-reactive protein (CRP', 'SMA', 'systemic multimodal analgesia (SMA, n\u2009=\u200956), group 2 were treated with the epidural analgesia (EDA, n\u2009=\u200920), group 3 had local high-volume infiltration anaesthesia (LHVIA, n\u2009=\u200920), group 4 were getting LHVIA with a wound catheter (LHVIAc, n\u2009=\u200948), and group 5 had a single blockade of the femoral nerve (FNB, n\u2009=\u200916']","['level of CRP and the severity of pain syndrome', 'severity of pain', 'evaluation of CRP and pain syndrome', 'CRP', 'lowest CRP indicators', 'CRP level', 'pain relief']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0162359', 'cui_str': 'Hypohidrotic X-linked ectodermal dysplasia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",160.0,0.0212272,A direct strong correlation was obtained between the level of CRP and the severity of pain syndrome in the knee joint during movement in four to six hours after surgery (n = ,"[{'ForeName': 'Dmitry A', 'Initials': 'DA', 'LastName': 'Tarasov', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Alexey V', 'Initials': 'AV', 'LastName': 'Lychagin', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Andrei G', 'Initials': 'AG', 'LastName': 'Yavorovkiy', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Lipina', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia. marina.lipina@icloud.com.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Tarasova', 'Affiliation': 'I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Sechenov University, Moscow, Russia.'}]",International orthopaedics,['10.1007/s00264-020-04551-8']
177,32272260,Influence of muscle oxygenation and nitrate-rich beetroot juice supplementation on O 2  uptake kinetics and exercise tolerance.,"We tested the hypothesis that acute supplementation with nitrate (NO 3 - )-rich beetroot juice (BR) would improve quadriceps muscle oxygenation, pulmonary oxygen uptake (V˙O 2 ) kinetics and exercise tolerance (T lim ) in normoxia and that these improvements would be augmented in hypoxia and attenuated in hyperoxia. In a randomised, double-blind, cross-over study, ten healthy males completed two-step cycle tests to T lim  following acute consumption of 210 mL BR (18.6 mmol NO 3 - ) or NO 3 - -depleted beetroot juice placebo (PL; 0.12 mmol NO 3 - ). These tests were completed in normobaric normoxia [fraction of inspired oxygen (FIO 2 ): 21%], hypoxia (FIO 2 : 15%) and hyperoxia (FIO 2 : 40%). Pulmonary V˙O 2  and quadriceps tissue oxygenation index (TOI), derived from multi-channel near-infrared spectroscopy, were measured during all trials. Plasma [nitrite] was higher in all BR compared to all PL trials (P < 0.05). Quadriceps TOI was higher in normoxia compared to hypoxia (P < 0.05) and higher in hyperoxia compared to hypoxia and normoxia (P < 0.05). T lim  was improved after BR compared to PL ingestion in the hypoxic trials (250 ± 44 vs. 231 ± 41 s; P = 0.006; d = 1.13), with the magnitude of improvement being negatively correlated with quadriceps TOI at T lim  (r = -0.78; P < 0.05). T lim  was not improved following BR ingestion in normoxia (BR: 364 ± 98 vs. PL: 344 ± 78 s; P = 0.087, d = 0.61) or hyperoxia (BR: 492 ± 212 vs. PL: 472 ± 196 s; P = 0.273, d = 0.37). BR ingestion increased peak V˙O 2  in hypoxia (P < 0.05), but not normoxia or hyperoxia (P > 0.05). These findings indicate that BR supplementation is more likely to improve T lim  and peak V˙O 2  in situations when skeletal muscle is more hypoxic.",2020,"BR ingestion increased peak V˙O 2  in hypoxia (P < 0.05), but not normoxia or hyperoxia (P > 0.05).",['ten healthy males completed two-step cycle tests to T lim  following acute consumption of 210\u202fmL BR (18.6\u202fmmol'],"['acute supplementation with nitrate (NO 3 - )-rich beetroot juice (BR', 'muscle oxygenation and nitrate-rich beetroot juice supplementation', 'BR supplementation']","['Quadriceps TOI', 'normobaric normoxia [fraction of inspired oxygen content', 'BR ingestion increased peak V˙O 2  in hypoxia', 'normoxia or hyperoxia', 'Plasma [nitrite', 'T lim', 'Pulmonary V˙O 2  and quadriceps tissue oxygenation index (TOI', 'O 2  uptake kinetics and exercise tolerance', 'quadriceps TOI', 'quadriceps muscle oxygenation, pulmonary oxygen uptake (V˙O 2 ) kinetics and exercise tolerance (T lim ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449205', 'cui_str': 'LIM'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439190', 'cui_str': 'mmol'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0449205', 'cui_str': 'LIM'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",10.0,0.173487,"BR ingestion increased peak V˙O 2  in hypoxia (P < 0.05), but not normoxia or hyperoxia (P > 0.05).","[{'ForeName': 'Stuart P', 'Initials': 'SP', 'LastName': 'Cocksedge', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, UK; School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, UK.""}, {'ForeName': 'Brynmor C', 'Initials': 'BC', 'LastName': 'Breese', 'Affiliation': 'School of Biological and Biomedical Sciences, Portland Square Building, Plymouth University, Drake Circus, Plymouth, UK.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Morgan', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, UK.""}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Nogueira', 'Affiliation': 'Section of Physiology, Division of Pulmonary, Critical Care & Sleep Medicine, Department of Medicine, University of California, San Diego, CA, USA; Instituto de Bioquímica Médica Leopoldo de Meis (Medical Biochemistry Institute Leopoldo de Meis), Federal University of Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, UK.""}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Wylie', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, UK.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, UK.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': ""Sport and Health Sciences, College of Life and Environmental Sciences, St. Luke's Campus, University of Exeter, Heavitree Road, Exeter, UK; School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, UK. Electronic address: S.Bailey2@lboro.ac.uk.""}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2020.03.007']
178,31483549,Cost-effectiveness of population-level proactive tobacco cessation outreach among socio-economically disadvantaged smokers: evaluation of a randomized control trial.,"AIMS


To estimate the cost-effectiveness at population-level of the OPT-IN proactive tobacco cessation outreach program for adult smokers enrolled in publicly funded health insurance plans for low-income persons (e.g. Medicaid).
DESIGN


Cost-effectiveness analysis using a state transition model based on data from the Offering Proactive Treatment Intervention (OPT-IN) randomized control trial.
SETTING


The trial was conducted in Minnesota, USA, and the economic analysis was conducted from the Medicaid program perspective.
PARTICIPANTS


Data were used from 2406 smokers who were randomized into the intervention or comparator groups.
INTERVENTION AND COMPARATOR


The intervention was comprised of proactive outreach (mailed invitation and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive telephone counseling). The comparator was usual care, which comprised access to a primary care physician, insurance coverage of Food and Drug Administration (FDA)-approved smoking cessation medications and the state's telephone quitline.
MEASUREMENTS


Smoking status, quality of life and health-care use at varying times, including at baseline and 1 year.
FINDINGS


The OPT-IN program cost an average of $84 per participant greater than the comparator. One year after randomization, the population-level, 6-month prolonged smoking abstinence rate was 16.5% in the proactive outreach intervention group and 12.1% in the usual care group (P < 0.05). The model projected that the proactive outreach intervention added $78 in life-time cost and generated 0.005 additional quality-adjusted life-years (QALYs), with an expected incremental cost-effectiveness ratio of $4231 per QALY. Probabilistic sensitivity analysis found that the proactive outreach intervention would be cost-effective against a willingness-to-pay threshold of $50 000/QALY approximately 68% of the time.
CONCLUSIONS


Population-level proactive tobacco treatment with personal telephone outreach was effective in achieving higher population-level quit rates and was cost-effective at various willingness-to-pay thresholds, compared with usual care (i.e. reactive treatment). Taken together with prior research, population-level proactive tobacco cessation outreach programs are judged to be highly cost-effective over the long term.",2019,"Taken together with prior research, population-level proactive tobacco cessation outreach programs are judged to be highly cost-effective over the long term.","['socio-economically disadvantaged smokers', 'adult smokers enrolled in publicly funded health insurance plans for low-income persons (e.g. Medicaid', 'Data were used from 2406 smokers who were randomized into the intervention or comparator groups']","['proactive outreach (mailed invitation and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive telephone counseling', 'OPT-IN proactive tobacco cessation outreach program', 'proactive outreach intervention', ""Food and Drug Administration (FDA)-approved smoking cessation medications and the state's telephone quitline"", 'personal telephone outreach', 'population-level proactive tobacco cessation outreach']","['Cost-effectiveness', 'population-level, 6-month prolonged smoking abstinence rate', 'Smoking status, quality of life and health-care use at varying times, including at baseline and 1\xa0year', 'cost-effective against a willingness-to-pay threshold', 'cost-effectiveness']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",2406.0,0.0283298,"Taken together with prior research, population-level proactive tobacco cessation outreach programs are judged to be highly cost-effective over the long term.","[{'ForeName': 'Viengneesee', 'Initials': 'V', 'LastName': 'Thao', 'Affiliation': 'University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Nyman', 'Affiliation': 'University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Nelson', 'Affiliation': 'VA Health Services Research and Development Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis, MN, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Clothier', 'Affiliation': 'VA Health Services Research and Development Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis, MN, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'VA Health Services Research and Development Center for Care Delivery and Outcomes Research (CCDOR), Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14752']
179,31847572,The new TV dinner: effects of television programming content on eating and attitudes towards exercise.,"Evidence exists for a negative influence of exercise/weight-loss television on explicit attitudes towards exercise. However, it is unclear if this is specific to viewing intense exercise or the overweight/obese status of the viewed exercisers. Additionally, exposure to exercise cues can induce people to eat more, reflecting compensatory eating in response to exercise cues rather than actual exercise. In this study, we examined the relative influence of viewing overweight/obese versus normal weight exercisers on eating (calories consumed) and attitudes towards exercise. 102 college students were randomized to view: 1) overweight/obese individuals engaging in vigorous exercise; 2) normal weight individuals engaging in vigorous exercise; or 3) no-exercise video with participants of various weight statuses (control condition). Participants subsequently completed a taste test assessing calories consumed; a computerized, implicit attitudes-towards-exercise task; and an explicit attitudes-towards-exercise questionnaire. Participants with higher BMIs and those viewing normal weight exercisers (vs. overweight/obese exercisers) ate significantly more. No significant effects were found for the interaction between BMI and video or for explicit or implicit attitudes towards exercise. This study extends findings of the impact of viewing vigorous exercise to eating behaviors. If replicated under naturalistic conditions, findings have implications for health promotion initiatives and television programming impacting overeating.",2020,No significant effects were found for the interaction between BMI and video or for explicit or implicit attitudes towards exercise.,"['102 college students', 'Participants with higher BMIs and those viewing normal weight exercisers (vs. overweight/obese exercisers']","['television programming content', 'viewing overweight/obese versus normal weight exercisers on eating (calories consumed) and attitudes towards exercise', 'taste test assessing calories consumed; a computerized, implicit attitudes-towards-exercise task; and an explicit attitudes-towards-exercise questionnaire', 'viewing vigorous exercise', 'view: 1) overweight/obese individuals engaging in vigorous exercise; 2) normal weight individuals engaging in vigorous exercise; or 3) no-exercise video with participants of various weight statuses (control condition']","['eating and attitudes towards exercise', 'interaction between BMI and video or for explicit or implicit attitudes towards exercise']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C3875042', 'cui_str': 'Attitude towards exercise (observable entity)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C3875042', 'cui_str': 'Attitude towards exercise (observable entity)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]",,0.0260631,No significant effects were found for the interaction between BMI and video or for explicit or implicit attitudes towards exercise.,"[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Szuhany', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1705990']
180,31121022,Effects of alirocumab on types of myocardial infarction: insights from the ODYSSEY OUTCOMES trial.,"AIMS


The third Universal Definition of Myocardial Infarction (MI) Task Force classified MIs into five types: Type 1, spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and proprotein convertase subtilisin-kexin Type 9 (PCSK9) inhibitors reduces risk of MI, but less is known about effects on types of MI. ODYSSEY OUTCOMES compared the PCSK9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8 mmol/L) despite intensive statin therapy. In a pre-specified analysis, we assessed the effects of alirocumab on types of MI.
METHODS AND RESULTS


Median follow-up was 2.8 years. Myocardial infarction types were prospectively adjudicated and classified. Of 1860 total MIs, 1223 (65.8%) were adjudicated as Type 1, 386 (20.8%) as Type 2, and 244 (13.1%) as Type 4. Few events were Type 3 (n = 2) or Type 5 (n = 5). Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI.
CONCLUSION


After ACS, alirocumab added to intensive statin therapy favourably impacted on Type 1 and 2 MIs. The data indicate for the first time that a lipid-lowering therapy can attenuate the risk of Type 2 MI. Low-density lipoprotein cholesterol reduction below levels achievable with statins is an effective preventive strategy for both MI types.",2019,"Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI.
CONCLUSION


","['18\xa0924 patients with recent acute coronary syndrome (ACS) and elevated LDL-C (≥1.8\u2009mmol/L) despite intensive statin therapy', 'spontaneous; Type 2, related to oxygen supply/demand imbalance; Type 3, fatal without ascertainment of cardiac biomarkers; Type 4, related to percutaneous coronary intervention; and Type 5, related to coronary artery bypass surgery', 'Median follow-up was 2.8\u2009years']","['alirocumab', 'alirocumab with placebo', 'PCSK9 inhibitor', 'lipid-lowering therapy']",['myocardial infarction'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441732', 'cui_str': 'Type 4 (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0457499', 'cui_str': 'Type 5 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",18924.0,0.0929233,"Alirocumab reduced first MIs [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.77-0.95; P = 0.003], with reductions in both Type 1 (HR 0.87, 95% CI 0.77-0.99; P = 0.032) and Type 2 (0.77, 0.61-0.97; P = 0.025), but not Type 4 MI.
CONCLUSION


","[{'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, 5 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), an F-CRIN network, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université Paris-Diderot, Sorbonne Paris-Cité, INSERM U-1148, 46 rue Henri Huchard, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Department of Epidemiology and Biostatistics, SUNY Downstate Medical Center School of Public Health, 450 Clarkson Avenue, Brooklyn, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, 75 Francis Street, Boston, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, 701 19th Street South - LHRB 310, Birmingham, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Paraguay 160, Rosario, Santa Fe, Argentina.'}, {'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Edelberg', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, USA.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, University of Latvia, Pilsonu Street 13, Riga, Latvia.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hanotin', 'Affiliation': 'Sanofi, 54-56 Rue la Boétie, Paris, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, 300 Pasteur Drive, S-102, Stanford, CA, USA.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, RC Leiden, The Netherlands.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, 200 Morris Street, Durham, NC, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Grant S-102, Stanford, CA, USA.'}, {'ForeName': 'Angele', 'Initials': 'A', 'LastName': 'Moryusef', 'Affiliation': 'Sanofi, 55 Corporate Drive, Bridgewater, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, 777 Old Saw Mill River Road, Tarrytown, NY, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, 200 Morris Street, Durham, NC, USA.'}, {'ForeName': 'Piyamitr', 'Initials': 'P', 'LastName': 'Sritara', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Ramathibodi Hospital/Mahidol University, Rama VI Road, Thailand.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Tricoci', 'Affiliation': 'CSL Behring, 1100 N Miami Blvd Ste 613, Durham, NC, USA.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, 1700 N. Wheeling Street, Aurora, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz299']
181,31981043,Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.,"BACKGROUND


Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC).
OBJECTIVE


Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC.
METHODS


A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain.
RESULTS


Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14 months of follow-up with a crossover at 6 months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
CONCLUSION


Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.",2020,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","['After Gastric Bypass Surgery', 'Forty-two patients']","['Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation', 'APC', 'SHAM']","['quality of life', 'satiety and greater weight loss', 'weight loss', 'EQ5D VAS scale', 'effectiveness and safety', 'total mean weight loss', 'weight loss, the return of early satiation', 'relapse of obesity occurs', 'Weight Regain']","[{'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1879736', 'cui_str': 'Argon Beam Coagulation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034380'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0222045'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",42.0,0.0503247,"Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02 kg in the APC and 11.52 kg in the control).
","[{'ForeName': 'Luiz Gustavo', 'Initials': 'LG', 'LastName': 'de Quadros', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil. Gustavo_quadros@hotmail.com.'}, {'ForeName': 'Manoel Galvão', 'Initials': 'MG', 'LastName': 'Neto', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'João Caetano', 'Initials': 'JC', 'LastName': 'Marchesini', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Teixeira', 'Affiliation': 'Orlando Health Hospital, Orlando, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grecco', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Roberto Luiz Kaiser', 'Initials': 'RLK', 'LastName': 'Junior', 'Affiliation': 'Beneficência Portuguesa Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Zundel', 'Affiliation': 'Jackson North Medical Center, University at Buffalo, Miami, USA.'}, {'ForeName': 'Idiberto José Zotarelli', 'Initials': 'IJZ', 'LastName': 'Filho', 'Affiliation': 'Kaiser Day Hospital, Sao Jose do Rio Preto, São Paulo, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'de Souza', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina, Universidade de São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Admar Concon', 'Initials': 'AC', 'LastName': 'Filho', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Lyz Bezerra', 'Initials': 'LB', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Almino Cardoso', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Medicine of ABC, Santo Andre, São Paulo, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Josemberg Marins', 'Initials': 'JM', 'LastName': 'Campos', 'Affiliation': 'Federal University of Pernambuco, Recife, Pernambuco, Brazil.'}]",Obesity surgery,['10.1007/s11695-020-04414-6']
182,31987724,"Initiation Age, Cumulative Prevalence, and Longitudinal Patterns of Handgun Carrying Among Rural Adolescents: A Multistate Study.","PURPOSE


Adolescent handgun carrying is a behavioral marker for youth interpersonal conflicts and an intervention point for violence prevention. Our knowledge about the epidemiology of adolescent handgun carrying mainly pertains to urban settings. Evidence on the initiation age, cumulative prevalence, and longitudinal patterns of this behavior and on handgun-related norms and peer behavior among male and female rural adolescents is scant.
METHODS


We used data from the control arm of the Community Youth Development Study, a community-randomized controlled trial of the Communities That Care prevention system. Annually, 1,039 males and 963 females were surveyed from Grade 6 (2005) to age 19 years (2012) in 12 rural towns across seven U.S. states.
RESULTS


In Grade 6, 11.5% of males and 2.8% of females reported past-year handgun carrying. Between Grade 6 and age 19 years, 33.7% of males and 9.6% of females reported handgun carrying at least once. Among participants who ever reported handgun carrying, 34.0% of males and 29.3% of females did so for the first time in Grade 6. Among participants who ever reported handgun carrying, 54.6% of males and 71.7% of females did so only one time over the seven study assessments. Greater proportions of participants who reported handgun carrying than those who did not do so endorsed prohandgun norms and had a peer who carried among both males (Grade 10: prevalence difference = 57%; 95% CI: 46%-67%) and females (Grade 10: prevalence difference = 45%; 95% CI: 12%-78%).
CONCLUSIONS


Rural adolescent handgun carrying is not uncommon and warrants etiologic research for developing culturally appropriate and setting-specific prevention programs.",2020,"Among participants who ever reported handgun carrying, 34.0% of males and 29.3% of females did so for the first time in Grade 6.","['male and female rural adolescents', 'Rural Adolescents', '1,039 males and 963 females were surveyed from Grade 6 (2005) to age 19 years (2012) in 12 rural towns across seven U.S. states', 'participants who ever reported handgun carrying, 54.6% of males and 71.7% of females']",[],[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]",[],[],,0.10069,"Among participants who ever reported handgun carrying, 34.0% of males and 29.3% of females did so for the first time in Grade 6.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rowhani-Rahbar', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, Washington; Department of Pediatrics, School of Medicine, University of Washington, Seattle, Washington; Firearm Injury & Policy Research Program, Harborview Injury Prevention & Research Center, University of Washington, Seattle, Washington. Electronic address: rowhani@uw.edu.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Oesterle', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, Seattle, Washington.'}, {'ForeName': 'Martie L', 'Initials': 'ML', 'LastName': 'Skinner', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, Seattle, Washington.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.11.313']
183,32078692,The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil.,"BACKGROUND


Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm.
OBJECTIVE


To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT).
METHODS


HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up.
RESULTS


A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
CONCLUSION


Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms.
VIDEO ABSTRACT


",2020,"Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
","['600 patients were randomized (HES, n\xa0=\xa0297 and BPC, n\xa0=\xa0303), including 28% with ruptured aneurysms', 'enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling']","['second-generation HES and bare platinum coil (BPC', 'Hydrogel Endovascular Aneurysm Treatment Trial (HEAT', 'Second-Generation Hydrogel Coil']","['Recurrence', 'minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up', 'adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms', 'packing density and both major and minor recurrence rates', 'initial occlusion rate', 'aneurysm recurrence using the Raymond-Roy scale']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162869', 'cui_str': 'Aneurysm, Ruptured'}, {'cui': 'C0007766', 'cui_str': 'Intracranial Aneurysm'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0222045'}]",600.0,0.104487,"Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.
","[{'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Bendok', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Abi-Aad', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Ward', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Kniss', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Rudy J', 'Initials': 'RJ', 'LastName': 'Rahme', 'Affiliation': 'Department of Neurological Surgery, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Salah G', 'Initials': 'SG', 'LastName': 'Aoun', 'Affiliation': 'Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Tarek Y', 'Initials': 'TY', 'LastName': 'El Ahmadieh', 'Affiliation': 'Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Najib E', 'Initials': 'NE', 'LastName': 'El Tecle', 'Affiliation': 'Department of Neurological Surgery, Saint Louis University Hospital, St. Louis, Missouri.'}, {'ForeName': 'Samer G', 'Initials': 'SG', 'LastName': 'Zammar', 'Affiliation': 'Department of Neurological Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Rami James N', 'Initials': 'RJN', 'LastName': 'Aoun', 'Affiliation': 'Department of General Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Devi P', 'Initials': 'DP', 'LastName': 'Patra', 'Affiliation': 'Department of Neurological Surgery, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Ansari', 'Affiliation': 'Department of Radiology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': 'Laboratoire de Neuroradiologie Interventionnelle, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Department of Neurological Surgery, North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Radiology, Stony Brook University Hospital, Stony Brook, New York.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Dabus', 'Affiliation': 'Interventional Neuroradiology and Neuroendovascular Surgery, Miami Cardiac and Vascular Institute, Miami, Florida.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Milot', 'Affiliation': 'Département de Chirurgie, CHU de Quebec, Quebec City, Canada.'}, {'ForeName': 'Josser E', 'Initials': 'JE', 'LastName': 'Delgado Almandoz', 'Affiliation': 'Department of Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, Minnesota.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Scott', 'Affiliation': 'Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'DeNardo', 'Affiliation': 'Department of Neurological Surgery, Goodman Campbell Brain and Spine, Indianapolis, Indiana.'}, {'ForeName': 'Shervin R', 'Initials': 'SR', 'LastName': 'Dashti', 'Affiliation': 'Department of Neurological Surgery Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurosurgery,['10.1093/neuros/nyaa006']
184,32079885,Volar Plate Fixation in Adults with a Displaced Extra-Articular Distal Radial Fracture Is Cost-Effective.,"BACKGROUND


To our knowledge, a health economic evaluation of volar plate fixation compared with plaster immobilization in patients with a displaced extra-articular distal radial fracture has not been previously conducted.
METHODS


A cost-effectiveness analysis of a multicenter randomized controlled trial was performed. Ninety patients were randomly assigned to volar plate fixation or plaster immobilization. The use of resources per patient was documented prospectively for up to 12 months after randomization and included direct medical, direct non-medical, and indirect non-medical costs due to the distal radial fracture and the received treatment.
RESULTS


The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]). (The 95% CIs throughout are bias-corrected and accelerated.) In addition, the mean total costs per patient were lower in patients treated with volar plate fixation (mean difference, -$299 [95% CI, -$1,880 to $1,024]). The difference in costs per QALY was -$1,838 (95% CI, -$12,604 to $9,787), in favor of volar plate fixation. In a subgroup analysis of patients who had paid employment, the difference in costs per QALY favored volar plate fixation by -$7,459 (95% CI, -$23,919 to $3,233).
CONCLUSIONS


In adults with a displaced extra-articular distal radial fracture, volar plate fixation is a cost-effective intervention, especially in patients who had paid employment. Besides its better functional results, volar plate fixation is less expensive and provides a better quality of life than plaster immobilization.
LEVEL OF EVIDENCE


Economic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]).","['Ninety patients', 'Adults with a Displaced Extra-Articular Distal Radial Fracture', 'patients who had paid employment', 'patients with a displaced extra-articular distal radial fracture', 'adults with a displaced extra-articular distal radial fracture']","['Volar Plate Fixation', 'plaster immobilization', 'volar plate fixation or plaster immobilization', 'volar plate fixation']","['costs per QALY favored volar plate fixation', 'mean total costs', 'mean quality-adjusted life-years (QALYs', 'costs per QALY']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0460977', 'cui_str': 'Plasters (physical object)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",90.0,0.154195,"The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]).","[{'ForeName': 'Marjolein A M', 'Initials': 'MAM', 'LastName': 'Mulders', 'Affiliation': 'Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Monique M J', 'Initials': 'MMJ', 'LastName': 'Walenkamp', 'Affiliation': 'Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Trauma Unit (M.A.M.M. and M.M.J.W.), Department of Surgery (S.v.D.), Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels W L', 'Initials': 'NWL', 'LastName': 'Schep', 'Affiliation': 'Department of Trauma and Hand Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00597']
185,32301137,Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data.,"BACKGROUND


Relamorelin, a pentapeptide ghrelin receptor agonist, accelerated gastric emptying significantly and improved symptoms in adults with diabetic gastroparesis in phase 2 trials.
AIM


To assess the safety and tolerability of relamorelin across phase 2 trials.
METHODS


Safety assessments in patients aged 18-75 years (weight, adverse events [AEs] and laboratory tests) from two randomised, double-blind phase 2 trials (NCT01571297, NCT02357420; results published previously) were reviewed descriptively. Analysis of covariance assessed treatment effect on glycated haemoglobin (HbA1c) and blood glucose post hoc. Phase 2a and 2b trial durations were, respectively, 4 weeks (relamorelin 10 µg once or twice daily [b.d.] or placebo b.d.) and 12 weeks (relamorelin 10, 30 or 100 µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins.
RESULTS


Among 204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes. Proportions of patients reporting serious AEs were similar across treatment groups, as were those with ≥1 treatment-emergent AE (TEAE). TEAE-related discontinuations were proportionally higher in relamorelin groups than placebo. Of 12 serious TEAEs in phase 2a, none occurred in >1 patient. In phase 2b, five serious TEAEs were reported in >1 patient, and one (100 µg) died (urosepsis), all unrelated to relamorelin. In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
CONCLUSIONS


Relamorelin showed acceptable safety and tolerability in phase 2 trials. Relamorelin may elevate blood glucose: this should be managed proactively in relamorelin-treated patients.",2020,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
","['adults with diabetic gastroparesis', '204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes', 'adults with diabetic gastroparesis in phase\xa02 trials', 'patients aged 18-75\xa0years (weight, adverse events [AEs] and laboratory tests']","['Relamorelin', 'placebo', 'relamorelin', 'placebo b.d.) and 12\xa0weeks (relamorelin 10, 30 or 100\xa0µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins']","['Overall safety', 'glycated haemoglobin (HbA1c) and blood glucose post hoc', 'TEAE-related discontinuations', 'blood glucose', 'safety and tolerability', 'acceptable safety and tolerability', 'HbA1c and fasting blood glucose levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C4045486', 'cui_str': 'relamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.432022,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively).
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McCallum', 'Affiliation': 'Division of Gastroenterology, Texas Tech University Health Sciences Center, El Paso, TX, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Tourkodimitris', 'Affiliation': 'Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kemps', 'Affiliation': 'Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Chemistry, Manufacturing and Controls, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Bertelsen', 'Affiliation': 'Clinical Pharmacology, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Iacob', 'Affiliation': 'Medical Safety, Allergan plc, Madison, NJ, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15711']
186,32290271,"Effects of Whey Protein Supplementation on Aortic Stiffness, Cerebral Blood Flow, and Cognitive Function in Community-Dwelling Older Adults: Findings from the ANCHORS A-WHEY Clinical Trial.","ANCHORS A-WHEY was a 12-week randomized controlled trial (RCT) designed to examine the effect of whey protein on large artery stiffness, cerebrovascular responses to cognitive activity and cognitive function in older adults.
METHODS


99 older adults (mean ± SD; age 67 ± 6 years, BMI 27.2 ± 4.7kg/m 2 , 45% female) were randomly assigned to 50g/daily of whey protein isolate (WPI) or an iso-caloric carbohydrate (CHO) control for 12 weeks (NCT01956994). Aortic stiffness was determined as carotid-femoral pulse wave velocity (cfPWV). Aortic hemodynamic load was assessed as the product of aortic systolic blood pressure and heart rate (Ao SBP × HR). Cerebrovascular response to cognitive activity was assessed as change in middle-cerebral artery (MCA) blood velocity pulsatility index (PI) during a cognitive perturbation (Stroop task). Cognitive function was assessed using a computerized neurocognitive battery.
RESULTS


cfPWV increased slightly in CHO and significantly decreased in WPI ( p  < 0.05). Ao SBP × HR was unaltered in CHO but decreased significantly in WPI ( p  < 0.05). Although emotion recognition selectively improved with WPI ( p  < 0.05), WPI had no effect on other domains of cognitive function or MCA PI response to cognitive activity ( p  > 0.05 for all).
CONCLUSIONS


Compared to CHO, WPI supplementation results in favorable reductions in aortic stiffness and aortic hemodynamic load with limited effects on cognitive function and cerebrovascular function in community-dwelling older adults.",2020,"Although emotion recognition selectively improved with WPI ( p  < 0.05), WPI had no effect on other domains of cognitive function or MCA PI response to cognitive activity ( p  > 0.05 for all).
","['older adults', 'Community-Dwelling Older Adults', 'community-dwelling older adults', '99 older adults (mean ± SD; age 67 ± 6 years, BMI 27.2 ± 4.7kg/m 2 , 45% female']","['whey protein', 'Whey Protein Supplementation', 'CHO, WPI supplementation', 'whey protein isolate (WPI) or an iso-caloric carbohydrate (CHO) control']","['Aortic hemodynamic load', 'carotid-femoral pulse wave velocity (cfPWV', 'cfPWV increased slightly in CHO', 'middle-cerebral artery (MCA) blood velocity pulsatility index (PI) during a cognitive perturbation (Stroop task', 'cognitive function or MCA PI response to cognitive activity', 'Ao SBP × HR', 'Aortic stiffness', 'large artery stiffness, cerebrovascular responses to cognitive activity and cognitive function', 'aortic systolic blood pressure and heart rate (Ao SBP × HR', 'Cerebrovascular response to cognitive activity', 'WPI', 'CHO', 'cognitive function and cerebrovascular function', 'Cognitive function', 'Aortic Stiffness, Cerebral Blood Flow, and Cognitive Function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0226003', 'cui_str': 'Structure of large artery'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",99.0,0.0226556,"Although emotion recognition selectively improved with WPI ( p  < 0.05), WPI had no effect on other domains of cognitive function or MCA PI response to cognitive activity ( p  > 0.05 for all).
","[{'ForeName': 'Wesley K', 'Initials': 'WK', 'LastName': 'Lefferts', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Augustine', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Spartano', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Hughes', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Brigid K', 'Initials': 'BK', 'LastName': 'Heenan', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Heffernan', 'Affiliation': 'Human Performance Laboratory, Department of Exercise Science, Syracuse University, Syracuse, NY 13244, USA.'}]",Nutrients,['10.3390/nu12041054']
187,32252062,"Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.","A single, subanesthetic dose of (R,S)-ketamine (ketamine) exerts rapid and robust antidepressant effects. Several groups previously reported that (2S,6S;2R,6R)-hydroxynorketamine (HNK) had antidepressant effects in rodents, and that (2R,6R)-HNK increased cortical electroencephalographic gamma power. This exploratory study examined the relationship between ketamine metabolites, clinical response, psychotomimetic symptoms, and gamma power changes in 34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a single ketamine infusion (0.5 mg/kg) over 40 min. Plasma concentrations of ketamine, norketamine, and HNKs were measured at 40, 80, 120, and 230 min and at 1, 2, and 3 days post-infusion. Linear mixed models evaluated ketamine metabolites as mediators of antidepressant and psychotomimetic effects and their relationship to resting-state whole-brain magnetoencephalography (MEG) gamma power 6-9 h post-infusion. Three salient findings emerged. First, ketamine concentration positively predicted distal antidepressant response at Day 11 post-infusion, and an inverse relationship was observed between (2S,6S;2R,6R)-HNK concentration and antidepressant response at 3 and 7 days post-infusion. Norketamine concentration was not associated with antidepressant response. Second, ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations at 40 min were positively associated with contemporaneous psychotomimetic symptoms; post-hoc analysis revealed that ketamine was the predominant contributor. Third, increased (2S,6S;2R,6R)-HNK maximum observed concentration (C max ) was associated with increased MEG gamma power. While contrary to preclinical observations and our a priori hypotheses, these exploratory results replicate those of a recently published study documenting a relationship between higher (2S,6S;2R,6R)-HNK concentrations and weaker antidepressant response in humans and provide further rationale for studying gamma power changes as potential biomarkers of antidepressant response.",2020,Norketamine concentration was not associated with antidepressant response.,['34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a'],"['placebo', 'ketamine', 'subanesthetic dose of (R,S)-ketamine (ketamine', '2S,6S;2R,6R)-hydroxynorketamine (HNK', 'Ketamine', 'single ketamine infusion']","['Plasma concentrations of ketamine, norketamine, and HNKs', '2S,6S;2R,6R)-HNK concentration and antidepressant response', 'ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations', 'distal antidepressant response', 'Norketamine concentration', 'cortical electroencephalographic gamma power']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0410552,Norketamine concentration was not associated with antidepressant response.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0663-6']
188,32121066,Micro RNA Expression after Ingestion of Fucoidan; A Clinical Study.,"Fucoidans are a class of fucose-rich sulfated polysaccharides derived from brown macroalgae that exert a range of biological activities in vitro and in vivo. To generate an unbiased assessment of pathways and processes affected by fucoidan, a placebo-controlled double-blind pilot study was performed in healthy volunteers. Blood samples were taken immediately before and 24 h after ingestion of a single dose of 1 g of  Undaria pinnatifida  fucoidan (UPF) or placebo. Levels of isolated miRNAs were analyzed using Taqman Open Array Human MicroRNA panels. Out of 754 miRNAs screened, UPF affected a total of 53 miRNAs. Pathway analysis using the TALOS data analysis tool predicted 29 different pathways and processes that were largely grouped into cell surface receptor signaling, cancer-related pathways, the majority of which were previously associated with fucoidans. However, this analysis also identified nine pathways and processes that have not been associated with fucoidans before. Overall, this study illustrates that even a single dose of fucoidans has the potential to affect the expression of genes related to fundamental cellular processes. Moreover, it confirms previous data that fucoidans influence immunity, cancer cells, inflammation, and neurological function.",2020,"Pathway analysis using the TALOS data analysis tool predicted 29 different pathways and processes that were largely grouped into cell surface receptor signaling, cancer-related pathways, the majority of which were previously associated with fucoidans.",['healthy volunteers'],"['placebo', 'Fucoidan']","['fucoidans influence immunity, cancer cells, inflammation, and neurological function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060794', 'cui_str': 'fucan sulfate'}]","[{'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}]",,0.138509,"Pathway analysis using the TALOS data analysis tool predicted 29 different pathways and processes that were largely grouped into cell surface receptor signaling, cancer-related pathways, the majority of which were previously associated with fucoidans.","[{'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Gueven', 'Affiliation': 'Pharmacy, School of Medicine, University of Tasmania, Hobart, TAS 7001, Australia.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Spring', 'Affiliation': 'Medical Oncology, Ingham Institute for Applied Medical Research, School of Medicine, Western Sydney University and SWS Clinical School, UNSW, Sydney, NSW 2170, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Holmes', 'Affiliation': 'Pharmacy, School of Medicine, University of Tasmania, Hobart, TAS 7001, Australia.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Ahuja', 'Affiliation': 'School of Health Sciences, University of Tasmania, Newnham, TAS 7248, Australia.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Eri', 'Affiliation': 'School of Health Sciences, University of Tasmania, Newnham, TAS 7248, Australia.'}, {'ForeName': 'Ah Young', 'Initials': 'AY', 'LastName': 'Park', 'Affiliation': 'Marinova Pty Ltd., Cambridge, TAS 7170, Australia.'}, {'ForeName': 'J Helen', 'Initials': 'JH', 'LastName': 'Fitton', 'Affiliation': 'Marinova Pty Ltd., Cambridge, TAS 7170, Australia.'}]",Marine drugs,['10.3390/md18030143']
189,30742471,Therapeutic alliance across trauma-focused and non-trauma-focused psychotherapies among veterans with PTSD.,"Trauma-focused psychotherapies for posttraumatic stress disorder (PTSD) are not widely utilized. Clinicians report concerns that direct discussion of traumatic experiences could undermine the therapeutic alliance, which may negatively impact retention and outcome. Studies among adolescents with PTSD found no difference in alliance between trauma-focused and non-trauma-focused psychotherapies, but this has not been tested among adults. The present study is a secondary analysis of a randomized trial of collaborative care, also known as care management, for PTSD. We examined patient-reported therapeutic alliance among 117 veterans with PTSD who participated in cognitive processing therapy (CPT, now called CPT + A; n = 54) or non-trauma-focused supportive psychotherapy for PTSD (n = 73) at VA community outpatient clinics. We tested the hypothesis that alliance in CPT would be noninferior to (i.e., not significantly worse than) non-trauma-focused psychotherapy using patient ratings on the Revised Helping Alliance Questionnaire. Patients' therapeutic alliance scores were high across both groups (CPT: M = 5.13, SD = 0.71, 95% CI [4.96, 5.30]; non-trauma-focused psychotherapy: M = 4.89, SD = 0.64, 95% CI [4.73, 5.05]). The difference between groups (0.23, 95% CI [0.01, 0.48]) was less than the ""noninferiority margin"" based on suggested clinical cutoffs (0.58 points on a 1-6 scale). These results held even after adjusting for veterans' demographic and clinical characteristics and change in PTSD symptoms from baseline to follow-up. Although there are concerns that direct discussion of traumatic experiences could worsen therapeutic alliance, patients report similar levels of alliance in CPT and non-trauma-focused supportive psychotherapy. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Studies among adolescents with PTSD found no difference in alliance between trauma-focused and non-trauma-focused psychotherapies, but this has not been tested among adults.","['veterans with PTSD', 'adolescents with PTSD', '117 veterans with PTSD who participated in cognitive processing therapy (CPT, now called CPT + A; n = 54) or non-trauma-focused supportive psychotherapy for PTSD (n = 73) at VA community outpatient clinics']",['Trauma-focused psychotherapies'],['therapeutic alliance scores'],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0413662,"Studies among adolescents with PTSD found no difference in alliance between trauma-focused and non-trauma-focused psychotherapies, but this has not been tested among adults.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Chen', 'Affiliation': 'Health Services Research & Development, Center of Innovation for Veteran-Centered and Value-Driven Care, Veterans Affairs Puget Sound Health Care System.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Fortney', 'Affiliation': 'HSR&D COIN for Veteran-Centered and Value- Driven Care, Veterans Affairs Puget Sound Health Care System, and Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Bergman', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System.'}, {'ForeName': 'Kendall C', 'Initials': 'KC', 'LastName': 'Browne', 'Affiliation': 'Center of Excellence in Substance Abuse and Treatment, Corporal Michael J. Crescenz VA Medical Center.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Grubbs', 'Affiliation': 'VA San Diego Health Care System.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Hudson', 'Affiliation': 'HSR&D, Central Arkansas Veterans Healthcare System.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Raue', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine.'}]",Psychological services,['10.1037/ser0000329']
190,31404159,The effects of increased acetate turnover on glucose-induced insulin secretion in lean and obese humans.,"Introduction


Increased endogenous acetate production (Ra) in rodents has been shown to activate the parasympathetic nervous system and thereby promote increased glucose-stimulated insulin secretion (GSIS), increased ghrelin secretion, hyperphagia and obesity.
Aim


To examine whether rates of acetate turnover are different in lean versus obese humans and whether increased acetate turnover promotes increased GSIS and increased ghrelin secretion in humans.
Methods


Basal acetate Ra was measured following an overnight fast in lean (BMI: 21.3 ± 1.1 Kg/m 2 ) and obese (30.2 ± 0.9 Kg/m 2 ,  P  = 0.00001) individuals. The subjects underwent two hyperglycemic (10 mmol/L) clamp studies to measure GSIS during a basal acetate infusion and during a high-dose acetate infusion increasing plasma acetate concentrations ∼5-fold.
Results


Basal acetate Ra was 30% higher in the lean compared to the obese subjects (257 ± 27 vs. 173 ± 18 μmol/min;  P  = 0.025). Basal plasma insulin concentrations were 4-fold higher in the obese than the lean subjects ( P  = 0.008) and increased 5-fold during hyperglycemia in both groups, independent of changes in plasma acetate concentrations. Fasting plasma ghrelin concentrations were 35% lower in the obese compared to the lean subjects ( P  = 0.015). During the hyperglycemic clamp, plasma ghrelin decreased by 42% in the lean group ( P  < 0.022 vs. basal) and did not change in the obese group.
Conclusion


Rates of endogenous acetate turnover are ∼30% higher in the lean subjects compared to the obese subjects, and increasing plasma acetate turnover does not promote increased GSIS or ghrelin secretion in either group.",2019,Fasting plasma ghrelin concentrations were 35% lower in the obese compared to the lean subjects ( P  = 0.015).,"['lean and obese humans', 'lean versus obese humans']",[],"['Basal acetate Ra', 'Methods\n\n\nBasal acetate Ra', 'GSIS or ghrelin secretion', 'Fasting plasma ghrelin concentrations', 'hyperglycemic clamp, plasma ghrelin', 'endogenous acetate turnover', 'plasma acetate concentrations', 'Basal plasma insulin concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}]",,0.0266485,Fasting plasma ghrelin concentrations were 35% lower in the obese compared to the lean subjects ( P  = 0.015).,"[{'ForeName': 'Kitt Falk', 'Initials': 'KF', 'LastName': 'Petersen', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Impellizeri', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Cline', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gerald I', 'Initials': 'GI', 'LastName': 'Shulman', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of clinical and translational science,['10.1017/cts.2018.342']
191,32268897,"Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial.","BACKGROUND


Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.
METHODS


Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m 2 , not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
RESULTS


We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m 2 , 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).
CONCLUSIONS


Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.
TRIAL REGISTRATION


European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012.",2020,The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses.,"['older people with advanced chronic kidney disease and serum bicarbonate concentrations <\u200922\u2009mmol/L', 'older patients with chronic kidney disease and low-grade acidosis (BiCARB', '300 participants between May 2013 and February 2017, mean age 74\u2009years, 86 (29%) female', 'We recruited adults aged ≥\u200960\u2009years with estimated glomerular filtration rate of <\u200930\u2009mL']","['sodium bicarbonate therapy', 'matching placebo', 'oral sodium bicarbonate', 'placebo', 'bicarbonate', 'SPPB: bicarbonate', 'Oral sodium bicarbonate', 'oral sodium bicarbonate therapy']","['generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained', 'glomerular filtration rate', 'Short Physical Performance Battery (SPPB', 'adverse events', 'physical function or renal function', 'Adverse events', 'higher costs and lower quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",300.0,0.705714,The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medicine,['10.1186/s12916-020-01542-9']
192,31752521,Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine.,"BACKGROUND


Fremanezumab, a fully humanized monoclonal antibody targeting calcitonin gene-related peptide, has demonstrated efficacy for the preventive treatment of migraine in adults.
OBJECTIVE


To evaluate the effect of fremanezumab treatment on acute headache medication use and migraine-associated symptoms in patients with episodic migraine.
METHODS


In the Phase 3 HALO trial, patients with episodic migraine were randomized to receive subcutaneous fremanezumab monthly (225 mg at baseline, weeks 4 and 8), fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), or placebo over a 12-week period. The secondary endpoint was change from baseline in the monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication; exploratory endpoints were change from baseline in the monthly number of days with nausea or vomiting, photophobia, or phonophobia.
RESULTS


Of 875 patients randomized, 865 were included in the analysis (monthly, n = 287; quarterly, n = 288; placebo, n = 290). Baseline mean ± standard deviation days with: Any acute headache medication use (monthly: 7.7 ± 3.4; quarterly: 7.8 ± 3.7; placebo: 7.7 ± 3.6), migraine-specific acute headache medication use (6.1 ± 3.1; 6.6 ± 3.1; 7.1 ± 3.0), nausea or vomiting (4.5 ± 3.6; 4.9 ± 3.7; 4.5 ± 3.3) and photophobia and phonophobia (5.5 ± 4.1; 6.3 ± 4.1; 6.0 ± 3.9) were similar among treatment arms. Fremanezumab reduced the number of days of acute headache medication use ([least-squares mean change vs. placebo] monthly: -1.4 [95% confidence interval: -1.84, -0.89],  p  < 0.001; quarterly: -1.3 [-1.76, -0.82],  p  < 0.001) and migraine-specific acute headache medication use (monthly: -2.2 [-2.80, -1.56],  p  < 0.001; quarterly: -2.2 [-2.81, -1.58],  p  < 0.001) compared with placebo. Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo.
CONCLUSIONS


Fremanezumab reduced the need for acute headache medications, including migraine-specific medications, while treating migraine-associated symptoms in patients with episodic migraine.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02629861.",2020,"Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo.
","['875 patients randomized', 'patients with episodic migraine', '4.5\u2009±\u20093.6; 4.9\u2009±\u20093.7; 4.5\u2009±\u20093.3) and photophobia and phonophobia (5.5\u2009±\u20094.1; 6.3\u2009±\u20094.1; 6.0\u2009±\u20093.9']","['fremanezumab', 'Fremanezumab', 'placebo', 'fremanezumab treatment', 'subcutaneous fremanezumab', 'fremanezumab quarterly (675\u2009mg at baseline, placebo']","['number of days of acute headache medication use', 'nausea or vomiting, photophobia, and phonophobia', 'monthly number of days with use of any acute headache mediation or migraine-specific acute headache medication', 'nausea or vomiting', 'monthly number of days with nausea or vomiting, photophobia, or phonophobia', 'migraine-specific acute headache medication use']","[{'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0744633', 'cui_str': 'Acute headache (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",865.0,0.411644,"Fremanezumab also reduced nausea or vomiting, photophobia, and phonophobia compared with placebo.
","[{'ForeName': 'Jan Lewis', 'Initials': 'JL', 'LastName': 'Brandes', 'Affiliation': 'Nashville Neuroscience Group, Vanderbilt Department of Neurology, Nashville, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Frazer, PA, USA.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Sakai', 'Affiliation': 'Saitama International Headache Center, Saitama Neuropsychiatric Institute, Saitama, Japan.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Aycardi', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Frazer, PA, USA.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Blankenbiller', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Frazer, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Grozinski-Wolff', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Frazer, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Frazer, PA, USA.'}, {'ForeName': 'Yuju', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Teva Pharmaceutical Industries Ltd, Frazer, PA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102419885905']
193,32286669,"Physio-Feedback and Exercise Program (PEER) Improves Balance, Muscle Strength, and Fall Risk in Older Adults.","A one-group pre/posttest study was conducted to examine the feasibility and effect size of an 8-week physio-feedback and exercise program (PEER) on improving balance, muscle strength, and fall risk. Nineteen participants (mean age = 76 years) received the intervention, which included visual physio-feedback by the BTrackS™ Assess Balance System, cognitive reframing, and a combined group- and home-based exercise program by a trained peer coach. Pre- and post-measurement outcomes were evaluated for balance, handgrip strength, and fall risk. Feasibility was assessed by dropout rate, safety, and adherence to exercise. Significant improvements were noted in dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk. Participants' attendance was 87.5%, with no fall incidence. The physio-feedback, cognitive reframing, and peer coaching facilitate older adults to align their perceived fall risk with physiological fall risk and motivate them to stay active. PEER intervention is feasible; safe; improves balance, muscle strength, and fall risk; and may enhance activity engagement.
TARGETS


Community-dwelling older adults.
INTERVENTION DESCRIPTION


Provide visual physio-feedback and cognitive reframing based on the fall risk appraisal matrix and participate in combined group- and home-based exercises by a trained peer coach.
MECHANISM OF ACTION


Align perceived and physiological fall risk, peer coaching to exercise.
OUTCOMES


Balance, handgrip strength, fall risk, and activity engagement. [Research in Gerontological Nursing, 13(6), 289-296.].",2020,"Significant improvements were noted in dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk.","['Community-dwelling older adults', 'Nineteen participants (mean age = 76 years) received the', 'Older Adults']","['intervention, which included visual physio-feedback by the BTrackS™ Assess Balance System, cognitive reframing, and a combined group- and home-based exercise program by a trained peer coach', '8-week physio-feedback and exercise program (PEER', 'PEER intervention', 'Physio-Feedback and Exercise Program (PEER']","['balance, handgrip strength, and fall risk', 'balance, muscle strength, and fall risk', 'Balance, handgrip strength, fall risk, and activity engagement', 'Improves Balance, Muscle Strength, and Fall Risk', 'dropout rate, safety, and adherence to exercise', 'dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0138067,"Significant improvements were noted in dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk.","[{'ForeName': 'Ladda', 'Initials': 'L', 'LastName': 'Thiamwong', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': ''}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Sole', 'Affiliation': ''}, {'ForeName': 'Boon Peng', 'Initials': 'BP', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Talbert', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20200324-01']
194,32289388,"A phase 2, multicenter, placebo-controlled study of single-dose squaric acid dibutyl ester to reduce frequency of outbreaks in patients with recurrent herpes labialis.",,2020,,[],[],[],[],[],[],,0.0560587,,"[{'ForeName': 'Anne Lynn S', 'Initials': 'ALS', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Golara', 'Initials': 'G', 'LastName': 'Honari', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Ludan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, California.'}, {'ForeName': 'Maria Alora', 'Initials': 'MA', 'LastName': 'Palli', 'Affiliation': 'Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Horn', 'Affiliation': 'Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Squarex, LLC, Pine Springs, Minnesota.'}, {'ForeName': 'Arkadiusz Z', 'Initials': 'AZ', 'LastName': 'Dudek', 'Affiliation': 'Squarex, LLC, Pine Springs, Minnesota.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'McTavish', 'Affiliation': 'Squarex, LLC, Pine Springs, Minnesota. Electronic address: hmctavish@squarex-pharma.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.04.021']
195,31613133,A new micro-intervention to increase the enjoyment and continued practice of meditation.,"New health behaviors are difficult to maintain and meditation is no different. We tested two key pathways of the upward spiral theory of lifestyle change (Fredrickson, 2013), which identifies positive emotions as critical ingredients for the maintenance of new health behaviors. The present experiment combined a laboratory session that introduced novices to meditation with a 3-week follow-up period to assess the extent to which study participants maintained this new health behavior. In a 2 × 2 experimental design, midlife adults (N = 240) were randomized to (a) learn about judicious ways to prioritize positivity (labeled ""prioritizing positivity plus"") or about a control topic that also featured the science of positive emotions and (b) follow a guided meditation based on either loving-kindness, which provided an opportunity to self-generate positive emotions, or mindfulness, which did not. All participants rated their emotions following the initial guided meditation and reported, week by week, whether they meditated during the ensuing 21 days. Analyses revealed that being exposed to the prioritizing positivity plus microintervention, relative to a control passage, amplified the effect of engaging in loving-kindness (vs. mindfulness) meditation on positive emotions. Additionally, the degree to which participants experienced positive emotions during first exposure to either meditation type predicted the frequency and duration at which they practiced meditation over the next 21 days. These findings show that the enjoyment of meditation can be experimentally amplified and that initial enjoyment predicts continued practice. Discussion spotlights the importance of differentiating effective and ineffective ways to pursue happiness. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"All participants rated their emotions following the initial guided meditation and reported, week by week, whether they meditated during the ensuing 21 days.",['midlife adults (N = 240'],"['learn about judicious ways to prioritize positivity (labeled ""prioritizing positivity plus"") or about a control topic that also featured the science of positive emotions and (b) follow a guided meditation based on either loving-kindness']",['positive emotions'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0150277'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024028', 'cui_str': 'Love'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",2019.0,0.0235407,"All participants rated their emotions following the initial guided meditation and reported, week by week, whether they meditated during the ensuing 21 days.","[{'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Van Cappellen', 'Affiliation': 'Social Science Research Institute.'}, {'ForeName': 'Lahnna I', 'Initials': 'LI', 'LastName': 'Catalino', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Fredrickson', 'Affiliation': 'Department of Psychology and Neuroscience.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000684']
196,32285978,Effect of e-cigarette advertisement themes on hypothetical e-cigarette purchasing in price-responsive adolescents.,"AIMS


To examine the effect on adolescents of exposure to different e-cigarette advertisement themes on reported likelihood of purchasing e-cigarettes in a hypothetical scenario.
DESIGN


Between-subjects design of four randomly assigned thematic conditions derived from a content analysis of 350 e-cigarette advertisements: general, flavor- and taste-themed, people- and product use-themed or control advertisements for bottled water.
SETTING


Virginia, USA.
PARTICIPANTS


Of 1360 adolescents (13-18 years old) participating, 1063 had complete data (519 current cigarette smokers, 544 tobacco-susceptible non-smokers).
MEASUREMENTS


Participants completed an e-cigarette purchase task, reporting the likelihood of buying an e-cigarette at various prices. Indices of abuse liability included price responsiveness (whether likelihood of purchase decreased with increasing prices) and, among price-responsive adolescents, breakpoint (highest price before definitely would not buy), maximum probability-weighted expenditure (O max  ) and price elasticity (how quickly willingness to purchase decreases as prices increase). Regressions controlled for demographics, prior tobacco ad exposure, tobacco/substance use and sensation-seeking.
FINDINGS


Prior advertisement exposure was positively associated with being price-responsive [odds ratio (OR) = 1.12, 95% confidence interval (CI) = 1.03, 1.22; P < 0.05]. Among price-responsive adolescents (n = 579), breakpoints were 58% higher in the flavor- and taste-themed condition (β = 0.46, 95% CI = <0.01, 0.92) and 75% higher in the people- and product use-themed condition (β = 0.56, 95% CI = 0.10, 1.03) compared with control (Ps < 0.05). Exposure to people- and product use-themed advertisements was associated with a 60% higher O max  (β = 0.47, 95% CI = 0.01, 0.93; P < 0.05). The general and people- and product use-themed conditions were associated with 19% (β = -0.21, 95% CI = -0.38, -0.04) and 21% (β = -0.24, 95% CI = -0.42, -0.06) lower elasticity, respectively (Ps < 0.05).
CONCLUSIONS


E-cigarette advertising exposure may increase reported likelihood of purchasing e-cigarettes, with effects differing by advertisement content. People- and product use-themed e-cigarette advertisements increased reported likelihood of purchasing in price-responsive adolescents.",2020,"FINDINGS


Prior ad exposure was positively associated with being price-responsive (OR 1.12, 95% CI 1.03, 1.22, p<0.05).","['Of 1360 adolescents (13-18 years old) participating, 1063 had complete data (519 current cigarette smokers, 544 tobacco-susceptible nonsmokers', 'Between-subjects design of four randomly-assigned thematic conditions derived from a content analysis of 350 e-cigarette ads: general', 'Virginia, USA', 'hypothetical e-cigarette purchasing in price-responsive adolescents', 'adolescents of exposure to different e-cigarette advertisement themes on reported likelihood of purchasing e-cigarettes in a hypothetical scenario']","['e-cigarette advertisement themes', 'flavor- and taste-themed, people- and product use-themed, or control ads for bottled water']","['e-cigarette purchase task, reporting the likelihood of buying an e-cigarette at various prices']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1572482', 'cui_str': 'Bottled Water'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",4.0,0.0673399,"FINDINGS


Prior ad exposure was positively associated with being price-responsive (OR 1.12, 95% CI 1.03, 1.22, p<0.05).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Barnes', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Rose S', 'Initials': 'RS', 'LastName': 'Bono', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alyssa K', 'Initials': 'AK', 'LastName': 'Rudy', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Hoetger', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Nicksic', 'Affiliation': 'Department of Health Behavior and Policy, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Cobb', 'Affiliation': 'Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15084']
197,32290892,Psychoeducation and motivational interviewing to reduce relapses and increase patients' involvement in antipsychotic treatment: interventional study.,"AIMS AND METHOD


To assess whether the combination of motivational interviewing and psychoeducation affects relapse rate and stimulates involvement of people with psychosis in their treatment. We conducted an interventional study including patients with schizophrenia or schizoaffective disorder treated with oral antipsychotics, without previous experience of long-acting injectable antipsychotics (LAIs). They were randomised to either psychoeducation with motivational interviewing or a control group. Hospital admissions 18 months before and after the intervention, and switches to LAIs 18 months after the intervention, were recorded.
RESULTS


The two groups each comprised 101 participants. Fourteen from the intervention group and seven from the control group switched to LAIs. Five in the intervention group instigated the switch themselves, compared with zero controls (P = 0.06). Fourteen in the intervention group were readmitted to hospital during follow-up, compared with 23 in the control group (P = 0.14).
CLINICAL IMPLICATIONS


Psychoeducation with motivational interviewing may increase patients' involvement in their treatment and reduce the relapse frequency.",2020,"Five in the intervention group instigated the switch themselves, compared with zero controls (P = 0.06).","['patients with schizophrenia or schizoaffective disorder treated with oral antipsychotics, without previous experience of long-acting injectable antipsychotics (LAIs', 'people with psychosis in their treatment']","['LAIs', 'Psychoeducation and motivational interviewing', 'motivational interviewing and psychoeducation', 'psychoeducation with motivational interviewing or a control group']",['readmitted to hospital'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.0251393,"Five in the intervention group instigated the switch themselves, compared with zero controls (P = 0.06).","[{'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Bröms', 'Affiliation': 'Unit of Clinical Epidemiology, Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lindah', 'Initials': 'L', 'LastName': 'Cahling', 'Affiliation': 'PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Berntsson', 'Affiliation': 'PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Öhrmalm', 'Affiliation': 'PRIMA Child and Adult Psychiatry, Stockholm, Sweden.'}]",BJPsych bulletin,['10.1192/bjb.2020.28']
198,32170727,Smoking cessation prior to gynecological surgery-A registry-based randomized trial.,"INTRODUCTION


Smoking cessation, both pre- and postoperatively, is important to reduce complications associated with surgery. Identifying feasible and effective means of alerting the patient before surgery to the importance of perioperative smoking cessation is a challenge to healthcare systems.
MATERIAL AND METHODS


A randomized registry-based trial using the web-version of the Swedish national quality register for gynecological surgery, GynOp, was performed (ClinicalTrials.gov NCT03942146). Current smokers scheduled for gynecological surgery were randomly assigned before surgery to group 1 (control group, no specific information), group 2 (web-based written information), group 3 (information to doctor that the woman was a smoker and should be recommended smoking cessation or group 4 (a combination of groups 2 and 3). Perioperative smoking habits were evaluated in a postoperative questionnaire 2 months after surgery. The treatment effect was estimated to be a 15% reduction in the number of smokers at the time of surgery. Thus, 94 women in each group were required, in total 376 women, using a one-sided test with an alpha level of 0.001 and a statistical power of 80%.
RESULTS


Participants (n = 1427) were recruited between 5 November 2015 and 6 December 2017. A total of 1137 smokers responded to the follow-up questionnaire (80%), with 486 women declining to participate, leaving 651 women eligible for analysis. Women who received both web-based information prior to surgery and information from a doctor, reported smoking cessation more often from 1 to 3 weeks preoperatively (Odds ratio [OR] 1.8, 95% confidence interval [CI] 1.0-3.3) and 1 to 3 weeks after surgery (OR 1.9, 95% CI 1.1-3.3) compared with the control group who received no specific information.
CONCLUSIONS


A combination of written information in the health declaration and a recommendation from a doctor regarding smoking cessation may be associated with higher odds of smoking cessation at 1-3 weeks pre- and postoperatively.",2020,"Women who received both web-based information prior to surgery and information from a doctor reported smoking cessation more often from 1-3 weeks preoperatively (Odds ratio, 95% confidence interval 1.8 [1.0-3.3]) and 1-3 weeks after surgery (1.9 [1.1-3.3]) compared to the control group who received no specific information.
","['1137 smokers responded to the follow-up questionnaire (80%) and 486 women declined participation leaving 651 women eligible for analysis', '94 women in each group were required, in total 376 women, using a one-sided test with an alfa level of 0.001 and a statistical power of 80', 'Current smokers scheduled for gynecological surgery', 'Participants (n = 1427) were recruited between November 5, 2015, and December 6, 2017']","['control group, no specific information, Group 2, web-based written information, Group 3, information to doctor that the woman was a smoker and should be recommended smoking cessation', 'Smoking cessation prior to gynecological surgery']","['smoking cessation', 'Perioperative smoking habits']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}]",1427.0,0.0572988,"Women who received both web-based information prior to surgery and information from a doctor reported smoking cessation more often from 1-3 weeks preoperatively (Odds ratio, 95% confidence interval 1.8 [1.0-3.3]) and 1-3 weeks after surgery (1.9 [1.1-3.3]) compared to the control group who received no specific information.
","[{'ForeName': 'Katja S', 'Initials': 'KS', 'LastName': 'Bohlin', 'Affiliation': 'Department of Obstetrics and Gynecology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Löfgren', 'Affiliation': 'Department of Obstetrics and Gynecology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Lindkvist', 'Affiliation': 'Department of Mathematics and Mathematical Statistics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Milsom', 'Affiliation': 'Department of Obstetrics and Gynecology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13843']
199,31451360,The LEAD trial-The effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: A randomised controlled trial.,"OBJECTIVES


This trial tested the effectiveness of a self-administered web-based decision aid, targeted at citizens with lower educational attainment, on informed choice about colorectal cancer screening participation as assessed by group levels of knowledge, attitudes and uptake.
METHODS


The randomised controlled trial was conducted among 2702 screening-naïve Danish citizens, 53-74 years old, with lower educational attainment. Baseline questionnaire respondents (62%) were allocated to intervention and control groups. Intervention group citizens received the decision aid. Outcomes were informed choice, worries and decisional conflict.
RESULTS


Analyses were conducted among 339 eligible citizens. The mean difference in knowledge score change between intervention and control group was 0.00 (95% confidence interval (CI): -0.38;0.38). Trends towards more positive screening attitudes (mean difference in score change: 0.72, 95% CI: -0.38;1.81) and higher screening uptake (7.6%, 95% CI:-2.2;17.4%) were observed. Worries (-0.33, 95% CI: -0.97;0.32) and decisional conflict (mean difference: -3.5, 95%CI: -7.0;-0.1) were slightly reduced.
CONCLUSIONS


The decision aid did not affect informed choice or knowledge. However, there were trends towards increased screening uptake and more positive screening attitudes.
PRACTICE IMPLICATIONS


Being a simple intervention and easily administered, the decision aid could represent a cost-effective way of enhancing screening uptake, and some elements of informed decision-making.",2020,"This trial tested the effectiveness of a self-administered web-based decision aid, targeted at citizens with lower educational attainment, on informed choice about colorectal cancer screening participation as assessed by group levels of knowledge, attitudes and uptake.
","['citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark', '339 eligible citizens', '2702 screening-naïve Danish citizens, 53-74 years old, with lower educational attainment', 'Baseline questionnaire respondents (62']","['self-administered web-based decision aid, targeted at citizens with lower educational attainment', '95%CI', 'decision aid']","['knowledge score change', 'decisional conflict', 'screening uptake', 'positive screening attitudes', 'higher screening uptake', 'Worries ', 'worries and decisional conflict']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}]",339.0,0.248507,"This trial tested the effectiveness of a self-administered web-based decision aid, targeted at citizens with lower educational attainment, on informed choice about colorectal cancer screening participation as assessed by group levels of knowledge, attitudes and uptake.
","[{'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Gabel', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Denmark. Electronic address: pergab@rm.dk.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Denmark; Division of Population Medicine, School of Medicine, Cardiff University, UK. Electronic address: EdwardsAG@cardiff.ac.uk.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kirkegaard', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Denmark. Electronic address: Pia.Kirkegaard@rm.dk.'}, {'ForeName': 'Mette Bach', 'Initials': 'MB', 'LastName': 'Larsen', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Denmark. Electronic address: metbacla@rm.dk.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Andersen', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Denmark; Department of Clinical Medicine, Aarhus University, Denmark. Electronic address: berand@rm.dk.'}]",Patient education and counseling,['10.1016/j.pec.2019.08.029']
200,31588607,Improving fitness increases dentate gyrus/CA3 volume in the hippocampal head and enhances memory in young adults.,"Converging evidence suggests a relationship between aerobic exercise and hippocampal neuroplasticity that interactively impacts hippocampally dependent memory. The majority of human studies have focused on the potential for exercise to reduce brain atrophy and attenuate cognitive decline in older adults, whereas animal studies often center on exercise-induced neurogenesis and hippocampal plasticity in the dentate gyrus (DG) of young adult animals. In the present study, initially sedentary young adults (18-35 years) participated in a moderate-intensity randomized controlled exercise intervention trial (ClinicalTrials.gov; NCT02057354) for a duration of 12 weeks. The aims of the study were to investigate the relationship between change in cardiorespiratory fitness (CRF) as determined by estimated  V   ˙   O   2     MAX  , hippocampally dependent mnemonic discrimination, and change in hippocampal subfield volume. Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults. Consistent with previous studies that found exercise-induced increases in anterior hippocampus in older adults, this result was specific to the hippocampal head, or most anterior portion, of the subregion. Our results also demonstrate a positive relationship between change in CRF and change in corrected accuracy for trials requiring the highest level of discrimination on a putative behavioral pattern separation task. This relationship was observed in individuals who were initially lower-fit, suggesting that individuals who show greater improvement in their CRF may receive greater cognitive benefit. This work extends animal models by providing evidence for exercise-induced neuroplasticity specific to the neurogenic zone of the human hippocampus.",2020,Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults.,"['young adults', 'older adults', 'initially sedentary young adults (18-35\u2009years) participated in a moderate-intensity randomized']",['controlled exercise intervention'],"['anterior hippocampus', 'cardiorespiratory fitness (CRF']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]",,0.0561769,Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults.,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nauer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Dunne', 'Affiliation': 'Center for Systems Neuroscience, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Chantal E', 'Initials': 'CE', 'LastName': 'Stern', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schon', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}]",Hippocampus,['10.1002/hipo.23166']
201,32285233,Understanding Our Peers with Pablo: Exploring the Merit of an Autism Spectrum Disorder De-stigmatisation Programme Targeting Peers in Irish Early Education Mainstream Settings.,"The political drive for inclusion means there are increasing numbers of children with autism spectrum disorder (ASD) being educated alongside their neurotypical peers. Pervasive victimisation has prompted the development of peer interventions targeting stigma. This study evaluated the 'Understanding Our Peers with Pablo' programme for effects on knowledge, attitudes and behavioural intentions of infant schoolchildren (N = 222) towards autistic peers. Classes were randomly assigned to an intervention or waitlist control condition. Change over time in knowledge of autism and attitudes and behavioural intentions towards familiar and unfamiliar peers was analysed using mixed analyses of variance. The intervention condition showed gains in knowledge and increased positive attitudes towards unfamiliar autistic peers (maintained over three-months). There were significant improvements in attitudes towards familiar autistic peers, and time-limited decreases in behavioural intentions across both conditions. Overall, results support the use of this programme in early-years education.",2020,"There were significant improvements in attitudes towards familiar autistic peers, and time-limited decreases in behavioural intentions across both conditions.","['children with autism spectrum disorder (ASD) being educated alongside their neurotypical peers', 'Peers with Pablo', 'infant schoolchildren (N\u2009=\u2009222) towards autistic peers']",['intervention or waitlist control condition'],"['gains in knowledge and increased positive attitudes towards unfamiliar autistic peers', 'knowledge, attitudes and behavioural intentions', 'Change over time in knowledge of autism and attitudes and behavioural intentions towards familiar and unfamiliar peers', 'attitudes towards familiar autistic peers, and time-limited decreases in behavioural intentions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",222.0,0.0693415,"There were significant improvements in attitudes towards familiar autistic peers, and time-limited decreases in behavioural intentions across both conditions.","[{'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'School of Psychology, University College Dublin, Dublin, D04 V1W8, Ireland. sonia.morris@ucdconnect.ie.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': ""O'Reilly"", 'Affiliation': 'School of Psychology, University College Dublin, Dublin, D04 V1W8, Ireland.'}, {'ForeName': 'Mitchell K', 'Initials': 'MK', 'LastName': 'Byrne', 'Affiliation': 'Department of Psychology, University of Wollongong, Wollongong, Australia.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04464-w']
202,32285238,"Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.","Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was ""very"" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.",2020,"Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20).","['ICD patients', 'patients with implantable cardioverter defibrillators', ' n\u2009=\u200911), compared to a Heart Healthy Education (HHE) control (n\u2009=\u200910), among ICD patients']","['positive psychology intervention (Quality of Life Therapy; QOLT', 'Implantable cardioverter defibrillators (ICDs', 'positive psychology interventions']","['participant engagement and interventionist protocol adherence', 'positive emotions', 'feasibility and acceptability']","[{'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",1.0,0.071956,"Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20).","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA.'}, {'ForeName': 'Lillian M', 'Initials': 'LM', 'LastName': 'Christon', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Rodrigue', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Frisch', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Serber', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA. serbere@musc.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00153-2']
203,31451361,The effects of self-management education tailored to health literacy on medication adherence and blood pressure control among elderly people with primary hypertension: A randomized controlled trial.,"OBJECTIVE


To evaluate the effects of self-management education tailored to health literacy on medication adherence and blood pressure control.
METHOD


This randomized controlled trial was conducted in 2018 with 118 elderly people with uncontrolled primary hypertension and inadequate health literacy. Self-management education was developed on the basis of the health literacy index. Medication adherence and blood pressure were assessed using 8-items Morisky Medication Adherence Scale and a mercury sphygmomanometer, respectively.
RESULTS


At baseline, there were no significant between-group differences regarding participants' demographic characteristics, medical history, and medication adherence. After the intervention, between-group comparisons adjusted for pretest scores showed a significant reduction in the mean score of systolic and diastolic blood pressure and increase adherence to medication due to intervention (P < 0.05). However, the proportions of controlled systolic and diastolic blood pressure were not statistically significant different between-group (P > 0.05).
CONCLUSION


Self-management education tailored to health literacy significantly promotes medication adherence but has no significant effects on control of blood pressure.
PRACTICE IMPLICATION


To promote adherence to antihypertensive medications, tailored patient education to Health literacy is recommended. Limited pieces of evidence are available on the effectiveness of health literacy index-based interventions, so further studies are required.",2020,"CONCLUSION


Self-management education tailored to health literacy significantly promotes medication adherence but has no significant effects on control of blood pressure.
","['elderly people with primary hypertension', '2018 with 118 elderly people with uncontrolled primary hypertension and inadequate health literacy']",['self-management education tailored to health literacy'],"['controlled systolic and diastolic blood pressure', ""participants' demographic characteristics, medical history, and medication adherence"", 'Medication adherence and blood pressure', 'medication adherence and blood pressure control', 'mean score of systolic and diastolic blood pressure and increase adherence to medication']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0554097,"CONCLUSION


Self-management education tailored to health literacy significantly promotes medication adherence but has no significant effects on control of blood pressure.
","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Delavar', 'Affiliation': 'Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: f-delavar@alumni.tums.ac.ir.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Pashaeypoor', 'Affiliation': 'Dept. of Community Health and Geriatric Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: sh-pashaeipour@sina.tums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Negarandeh', 'Affiliation': 'Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: rnegarandeh@tums.ac.ir.'}]",Patient education and counseling,['10.1016/j.pec.2019.08.028']
204,31451362,Effects of a parenting sexual education program for immigrant parents: A cluster randomized trial.,"OBJECTIVES


The aim was to assess the effects of a parental sex education program on knowledge, attitudes, self-efficacy, and practices among immigrant parents.
METHODS


A cluster randomized trial was conducted at immigrant activity centers in northern Taiwan. Recruited participants were randomly assigned to an experimental (four centers, n = 86) or control (four centers, n = 67) group. A practical booklet and a booster session were delivered. In total, 132 participants' knowledge, attitudes, self-efficacy, and practice of parenting sexual education were examined at the baseline and 6 weeks after the intervention.
RESULTS


After controlling for possible confounders, the posttest scores of self-efficacy of the experimental group were higher than those of the control group. The Johnson-Neyman procedure indicated that the intervention was effective for participants who had pretest knowledge, attitude, and practice scores of <14.62, <110.27, and <41.5, respectively.
CONCLUSIONS


An intervention with both practical booklet and booster session can improve knowledge, attitudes, self-efficacy and practices of parental sex education among immigrant parents.
PRACTICE IMPLICATIONS


In addition to practical booklets, health care professionals should provide booster sessions that meet the needs of immigrant parents to prevent sexual problems among children and adolescents at an early age.",2020,"The Johnson-Neyman procedure indicated that the intervention was effective for participants who had pretest knowledge, attitude, and practice scores of <14.62, <110.27, and <41.5, respectively.
","['132 participants', 'immigrant parents', 'immigrant activity centers in northern Taiwan', 'children and adolescents at an early age']","['parental sex education program', 'parenting sexual education program']","['knowledge, attitudes, self-efficacy and practices of parental sex education', 'knowledge, attitudes, self-efficacy, and practices', 'posttest scores of self-efficacy', 'knowledge, attitudes, self-efficacy, and practice of parenting sexual education']","[{'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0036879', 'cui_str': 'Sex Education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036879', 'cui_str': 'Sex Education'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",132.0,0.0398126,"The Johnson-Neyman procedure indicated that the intervention was effective for participants who had pretest knowledge, attitude, and practice scores of <14.62, <110.27, and <41.5, respectively.
","[{'ForeName': 'Pei-I', 'Initials': 'PI', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Department of Nursing, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Hsiang-Ru', 'Initials': 'HR', 'LastName': 'Lai', 'Affiliation': 'Department of Health Promotion and Health Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Pi-Chu', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': 'Master Program in Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Kuo', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Kuang', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Research Center of Biostatistics, School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Su-Ru', 'Initials': 'SR', 'LastName': 'Chen', 'Affiliation': 'Post-Baccalaureate Program in Nursing and School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Pi-Hsia', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan. Electronic address: pihsia@tmu.edu.tw.'}]",Patient education and counseling,['10.1016/j.pec.2019.08.027']
205,31943738,Positive psychology intervention for couples: A pilot study.,"In this randomized study, a multicomponent, theory-driven, autonomous self-help positive psychology intervention (PPI) for couples was examined. This intervention was not designed for distressed couples but rather to address autonomous couples with a good initial level of functioning who, nonetheless, wished to improve it. The objective was to assess the efficacy of the PPI on satisfaction with life, affective life, communication patterns, and dyadic adjustment in each member of the dyad. The 4-week PPI encompassed dyadic and individual daily activities. Thirty-eight couples were assigned to an intervention group (n = 20 couples) or a waiting list control (WLC) group (n = 18 couples). Assessments were conducted prior to and after the PPI, with an immediate post-test and a follow-up. Ninety-two percent of the PPI was completed by the participants. Linear mixed models revealed improvements in positive emotions, communication patterns of mutuality, and dyadic adjustment from the pretest to the immediate post-test in the intervention group compared with the WLC group. Effects of dyadic adjustment were maintained from pretest to 1-month follow-up in the intervention group. This pilot study suggests that the realization of intentional dyadic activities presents an interesting approach to contribute to individual positive emotions and dyadic functioning.",2020,"Linear mixed models revealed improvements in positive emotions, communication patterns of mutuality and dyadic adjustment from the pre-test to the immediate post-test in the intervention group compared to the WLC group.","['Couples', 'Thirty-eight couples']","['theory-driven, autonomous self-help positive psychology intervention (PPI', 'waiting list control (WLC', 'WLC', 'PPI', 'Positive Psychology Intervention']","['positive emotions, communication patterns of mutuality and dyadic adjustment', 'satisfaction with life, affective life, communication patterns and dyadic adjustment']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}]","[{'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",38.0,0.0199668,"Linear mixed models revealed improvements in positive emotions, communication patterns of mutuality and dyadic adjustment from the pre-test to the immediate post-test in the intervention group compared to the WLC group.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': 'CNRS, UMR 9193-SCALab-Sciences Cognitives et Sciences Affectives, Univ. Lille, Lille, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': 'CNRS, UMR 9193-SCALab-Sciences Cognitives et Sciences Affectives, Univ. Lille, Lille, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Laboratoire de psychologie des Pays de la Loire, LPPL, EA 4638, Univ. Nantes, Nantes, France.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2925']
206,32285449,"Acceptability and feasibility of a brief substance use intervention for adolescents in Cape Town, South Africa: A pilot study.","Substance use is prevalent among South African adolescents, but few interventions exist to reduce risk of harm. This study assesses the feasibility, acceptability and preliminary effects of a brief intervention for reducing adolescent substance use and other risk behaviours. This single-arm feasibility test recruited 30 substance-using adolescents and their primary caregiver. Participants received separate interventions (2 sessions for adolescents, 1 session for caregivers), with a subsample randomly selected for post-intervention interviews. Feasibility was measured by the proportion of eligible adolescents who were enrolled and retained in the study. Interviews explored acceptability, and changes in outcomes from baseline to 1-month follow-up assessed preliminary effects of the intervention. Thirty of 43 (69.8%) eligible adolescents and their caregivers were enrolled, with 29 adolescents (96.7%) and 28 caregivers (93.3%) completing the intervention. Twenty-eight adolescents (93.3%) and 29 caregivers (96.7%) were retained at follow-up. Frequency of alcohol, cannabis use and delinquent-type behaviours decreased significantly from baseline to follow-up. Participants appreciated the intervention content and delivery and felt that it facilitated behaviour change. Suggestions for improving the intervention were provided. This study found that the intervention is feasible, acceptable and had promising effects on adolescent behaviour. Efficacy must be established with a randomised controlled trial.",2020,"This study assesses the feasibility, acceptability and preliminary effects of a brief intervention for reducing adolescent substance use and other risk behaviours.","['eligible adolescents who were enrolled and retained in the study', 'Twenty-eight adolescents (93.3%) and 29 caregivers (96.7%) were retained at follow-up', '30 substance-using adolescents and their primary caregiver', 'South African adolescents', 'Thirty of 43 (69.8%) eligible adolescents and their caregivers were enrolled, with 29 adolescents (96.7%) and 28 caregivers (93.3%) completing the intervention', 'adolescents in Cape Town, South Africa']","['substance use intervention', 'separate interventions']","['adolescent substance use and other risk behaviours', 'Acceptability and feasibility', 'Frequency of alcohol, cannabis use and delinquent-type behaviours']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0522175', 'cui_str': 'Delinquent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",,0.0901033,"This study assesses the feasibility, acceptability and preliminary effects of a brief intervention for reducing adolescent substance use and other risk behaviours.","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Carney', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Carrico', 'Affiliation': 'Department of Public Health Sciences, Division of Prevention Science & Community Health, University of Miami, Coral Gables, FL, USA.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12668']
207,31455566,Feasibility of a clinic-delivered adolescent and pediatrician communication intervention on patient participatory behaviors and behavior change: TIC TAC pilot study.,"OBJECTIVES


Pediatrician-adolescent communication can improve adolescent health. We conducted a two-arm design to pilot-test an intervention that randomized adolescents to receive a Feedback Guide to promote engaged conversations. We hypothesized that adolescents who received the Guide would be more participatory.
METHODS


We recruited 12 pediatricians and 29 adolescents. Clinic staff enrolled adolescents using a tablet that enabled consenting, assessment of high-risk behaviors, and audio recording of encounters. We surveyed adolescents immediately and two months after the encounter.
RESULTS


Adolescents who received the intervention were more participatory than adolescents who did not. Pediatricians counseled on 20 of 32 high-risk behaviors with no significant arm differences. At follow-up, adolescents changed 9 of 32 behaviors; 6 were among 4 of adolescents in the intervention arm. Adolescents in the intervention arm were also more likely to report that counseling would help them change their behavior; these encounters were slightly longer than control arm encounters.
CONCLUSIONS


We confirmed feasibility of a streamlined approach to enrolling and audio recording encounters. The Feedback Guide improved adolescent participation and might have helped them adopt healthier behaviors.
PRACTICE IMPLICATIONS


Adolescents can be primed to be participatory and can change their behaviors after a meaningful encounter with their pediatrician.",2020,"Adolescents in the intervention arm were also more likely to report that counseling would help them change their behavior; these encounters were slightly longer than control arm encounters.
","['12 pediatricians and 29 adolescents', 'Adolescents']","['Feedback Guide to promote engaged conversations', 'clinic-delivered adolescent and pediatrician communication intervention']",[],"[{'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]",[],32.0,0.0515652,"Adolescents in the intervention arm were also more likely to report that counseling would help them change their behavior; these encounters were slightly longer than control arm encounters.
","[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Populations Sciences, Duke Cancer Institute, Durham, USA; Department of Population Health Sciences, Duke School of Medicine, Durham, USA. Electronic address: kathryn.pollak@duke.edu.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Populations Sciences, Duke Cancer Institute, Durham, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Chung', 'Affiliation': 'Department of Pediatrics, Duke School of Medicine, Durham, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., Durham, USA.'}, {'ForeName': 'Terrill', 'Initials': 'T', 'LastName': 'Bravender', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, USA.'}]",Patient education and counseling,['10.1016/j.pec.2019.08.025']
208,31466882,Race moderates the effects of Motivational Interviewing on smoking cessation induction.,"OBJECTIVE


Health disparities necessitate exploration of how race moderates response to smoking cessation treatment. Data from a randomized clinical trial of Motivational Interviewing (MI) for smoking cessation induction were used to explore differential treatment response between African American (AA) vs Non-Black (NB) smokers.
METHODS


Adult tobacco smokers (138 AA vs 66 NB) with low desire to quit were randomly assigned to four sessions of MI or health education (HE). Outcomes (e.g., quit attempts) were assessed 3- and 6-months.
RESULTS


There was evidence of a Race by Treatment interaction such that MI was less effective than HE in AA smokers. Mean Cohen's d for the interaction effect was -0.32 (95% CI [-0.44, -0.20]). However, the race interaction could be accounted for by controlling for baseline relationship status and communication preference (wants directive approach).
CONCLUSIONS


MI may be less effective for smoking cessation induction in AA vs NB smokers when compared to another active and more directive therapy. The differential response between races may be explained by psychosocial variables.
PRACTICE IMPLICATIONS


MI may not be an ideal choice for all African American smokers. Patients' relationship status and preference for a directive counseling approach might explain disparities in response to MI treatment.",2020,"Data from a randomized clinical trial of Motivational Interviewing (MI) for smoking cessation induction were used to explore differential treatment response between African American (AA) vs Non-Black (NB) smokers.
","['Adult tobacco smokers (138 AA vs 66 NB) with low desire to quit', 'African American smokers', 'African American (AA) vs Non-Black (NB) smokers']","['MI or health education (HE', 'Motivational Interviewing (MI', 'Motivational Interviewing']",['smoking cessation induction'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0018701'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.0181493,"Data from a randomized clinical trial of Motivational Interviewing (MI) for smoking cessation induction were used to explore differential treatment response between African American (AA) vs Non-Black (NB) smokers.
","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Grobe', 'Affiliation': 'JEGrobe Consulting, 9209 Heatherdale Drive, Dallas, Texas, 75243, United States. Electronic address: jamesegrobe@gmail.com.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Division of Health Services and Outcomes Research, Children's Mercy Kansas City Hospitals and Clinics, and Schools of Medicine and Pharmacy, University of Missouri - Kansas City, 2401 Gillham Road, Kansas City, MO, 64108, United States. Electronic address: kgoggin@cmh.edu.""}, {'ForeName': 'Kari Jo', 'Initials': 'KJ', 'LastName': 'Harris', 'Affiliation': 'School of Public and Community Health Sciences, 32 Campus Drive Skaggs Building Room 352, The University of Montana, Missoula, Montana, 406-243-4685, United States. Electronic address: kari.harris@mso.umt.edu.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine & Public Health, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 1008, 4004 Robinson, Kansas City, KS, 66160, United States. Electronic address: krichter@kumc.edu.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, 1415 Washington Heights, Ann Arbor, MI, 48109-2029, United States. Electronic address: kresnic@umich.edu.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, 2401 Gillham Road, Kansas City, MO, 64108, United States. Electronic address: dcatley@cmh.edu.""}]",Patient education and counseling,['10.1016/j.pec.2019.08.023']
209,31362541,Invasive Versus Medical Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome.,"BACKGROUND


The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials.
METHODS


In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function).
RESULTS


Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years' follow-up (median [interquartile range], 744 [570-853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months.
CONCLUSIONS


More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751.",2019,"Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months.
","['non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals', '17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group', 'patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes', 'Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29', 'Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome', 'Medically stabilized patients', 'non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts']","['percutaneous coronary intervention', 'routine invasive management', 'invasive management (invasive group) or noninvasive management (medical group', 'Invasive Versus Medical Management', 'invasive versus noninvasive management']","['composite safety outcome', 'composite outcome for efficacy', 'serious adverse event', 'efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function', 'Health status (EuroQol 5 Dimensions) and angina class', 'efficacy or safety outcome']","[{'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",217.0,0.0626605,"Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months.
","[{'ForeName': 'Matthew M Y', 'Initials': 'MMY', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Colette E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Corcoran', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Ammani', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., A.B., M.B.M., A.S., A.P.R., C.B.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Cialdella', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Novalia P', 'Initials': 'NP', 'LastName': 'Sidik', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Margaret B', 'Initials': 'MB', 'LastName': 'McEntegart', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Rae', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Stuart H M', 'Initials': 'SHM', 'LastName': 'Hood', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Peat', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Iain N', 'Initials': 'IN', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (M.M.Y.L., S.H.M.H., E.E.P., I.N.F., C.L.M., A.J.C.).'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Murphy', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (M.M.Y.L., S.H.M.H., E.E.P., I.N.F., C.L.M., A.J.C.).'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Cormack', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (M.M.Y.L., S.H.M.H., E.E.P., I.N.F., C.L.M., A.J.C.).'}, {'ForeName': 'Nikolay B', 'Initials': 'NB', 'LastName': 'Bukov', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, United Kingdom (N.B.B., K.P.B.).'}, {'ForeName': 'Kanarath P', 'Initials': 'KP', 'LastName': 'Balachandran', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, United Kingdom (N.B.B., K.P.B.).'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics (I.F., A.M.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wu', 'Affiliation': 'Health Economics and Health Technology Assessment (O.W.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics (I.F., A.M.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Sarah J E', 'Initials': 'SJE', 'LastName': 'Barry', 'Affiliation': 'Department of Mathematics and Statistics, University of Strathclyde, United Kingdom (S.J.E.B.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, United Kingdom (M.M.Y.L., M.C.P., P.R., J.S., C.E.J., D.S.C., K.M., P.C., N.P.S., M.B.M., A.S., A.P.R., S.H.M.H., E.E.P., K.G.O., C.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.007830']
210,32146218,Blended care in the treatment of subthreshold symptoms of depression and psychosis in emerging adults: A randomised controlled trial of Acceptance and Commitment Therapy in Daily-Life (ACT-DL).,"In this study, the feasibility and efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL), ACT augmented with a daily life application, was investigated in 55 emerging adults (age 16 to 25) with subthreshold depressive and/or psychotic complaints. Participants were randomized to ACT-DL (n = 27) or to active control (n = 28), with assessments completed at pre- and post-measurement and 6- and 12-months follow-up. It took up to five (ACT-DL) and 11 (control) months to start group-based interventions. Participants attended on average 4.32 out of 5 ACT-DL sessions. On the app, they filled in on average 69 (48%) of signal-contingent beep-questionnaires, agreed to 15 (41%) of offered beep-exercises, initiated 19 on-demand exercises, and rated ACT-DL metaphors moderately useful. Relative to active control, interviewer-rated depression scores decreased significantly in ACT-DL participants (p = .027). Decreases in self-reported depression, psychotic-related distress, anxiety, and general psychopathology did not differ between conditions. ACT-DL participants reported increased mean NA (p = .011), relative to active controls. Mean PA did not change in either group, nor did psychological flexibility. ACT-DL is a feasible intervention, although adaptations in future research may improve delivery of and compliance with the intervention. There were mixed findings for its efficacy in reducing subthreshold psychopathology in emerging adults. Dutch Trial Register no.: NTR3808.",2020,"Relative to active control, interviewer-rated depression scores decreased significantly in ACT-DL participants (p = .027).","['55 emerging adults (age 16 to 25) with subthreshold depressive and/or psychotic complaints', 'subthreshold symptoms of depression and psychosis in emerging adults', 'Participants attended on average 4.32 out of 5 ACT-DL sessions']","['ACT-DL', 'Acceptance and Commitment Therapy', 'active control']","['Mean PA', 'self-reported depression, psychotic-related distress, anxiety, and general psychopathology', 'Relative to active control, interviewer-rated depression scores', 'psychological flexibility', 'subthreshold psychopathology', 'mean NA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4517760', 'cui_str': '4.32'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",55.0,0.104916,"Relative to active control, interviewer-rated depression scores decreased significantly in ACT-DL participants (p = .027).","[{'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'van Aubel', 'Affiliation': 'Department of Neurosciences, Center for Contextual Psychiatry (CCP), University of Leuven, Leuven, Belgium. Electronic address: evelyne.vanaubel@kuleuven.be.'}, {'ForeName': 'Jindra Myrthe', 'Initials': 'JM', 'LastName': 'Bakker', 'Affiliation': 'Department of Neurosciences, Center for Contextual Psychiatry (CCP), University of Leuven, Leuven, Belgium; Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: jindra.bakker@maastrichtuniversity.nl.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Batink', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands; U-Center, Epen, Netherlands. Electronic address: tim.batink@maastrichtuniversity.nl.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: stijn.michielse@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: lies.goossens@maastrichtuniversity.nl.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Health Psychology, Faculty of Psychology, University of Leuven, Leuven, Belgium. Electronic address: koen.schruers@maastrichtuniversity.nl.'}, {'ForeName': 'Ritsaert', 'Initials': 'R', 'LastName': 'Lieverse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: r.lieverse@maastrichtuniversity.nl.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands; Institute for Mental Health Care Eindhoven (GGzE), Eindhoven, the Netherlands. Electronic address: Machteld.Marcelis@GGZE.nl.'}, {'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: t.vanamelsvoort@maastrichtuniversity.nl.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': ""Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Psychosis Studies, Institute of Psychiatry, King's College London, King's Health Partners, London, England, United Kingdom; Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: J.J.vanOs-2@umcutrecht.nl.""}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Psychiatry (UCP), Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), the Netherlands. Electronic address: m.c.wichers@umcg.nl.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vaessen', 'Affiliation': 'Department of Neurosciences, Center for Contextual Psychiatry (CCP), University of Leuven, Leuven, Belgium. Electronic address: thomas.vaessen@kuleuven.be.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Reininghaus', 'Affiliation': ""Department of Psychiatry and Psychology, School for Mental Health and Neuroscience (MHeNs), EURON, Maastricht University Medical Center, Maastricht, the Netherlands; Department of Public Mental Health, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany; Center for Epidemiology and Public Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Electronic address: Ulrich.Reininghaus@zi-mannheim.de.""}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Myin-Germeys', 'Affiliation': 'Department of Neurosciences, Center for Contextual Psychiatry (CCP), University of Leuven, Leuven, Belgium. Electronic address: inez.germeys@kuleuven.be.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103592']
211,32285979,Effectiveness of nicotine gum in preventing lapses in the face of temptation to smoke among non-daily smokers: a secondary analysis.,"BACKGROUND AND AIMS


Non-daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of nicotine gum with placebo on quitting smoking in non-daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using nicotine gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations.
DESIGN


Within a 6-week randomized, placebo-controlled clinical trial of nicotine gum, analyses contrasted the outcome of temptation episodes where gum was or was not used.
SETTING


Smoking cessation research clinic in Pittsburgh, PA, USA.
PARTICIPANTS


A total of 255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation.
INTERVENTION


Nicotine gum (2 mg) versus placebo for up to 8 weeks, with as-needed dosing instructions.
MEASUREMENTS


Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable.
FINDINGS


Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant gum use × active treatment interaction (P = 0.0009). Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22-0.94]; when gum was not used, the assigned gum condition made no significant difference (OR = 1.53; 0.78-3.01; Bayes factor = 0.14). The nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06).
CONCLUSIONS


When used in response to temptation to smoke, 2 mg nicotine gum can help to prevent lapses among non-daily smokers.",2020,"Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo (OR=0.45, 0.22-0.94); when gum was not used, the assigned gum condition made no significant difference (OR=1.53, 0.78-3.01; Bayes Factor=0.14).","['temptation to smoke among non-daily smokers', 'non-daily smokers', 'Smoking cessation research clinic in Pittsburgh, PA, USA', 'Participants reported 2,713 temptation episodes, 46.0% (1,248) of which resulted in smoking (lapsing', '255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation']","['nicotine gum', 'Nicotine gum (2 mg) vs placebo', 'nicotine gum, vs placebo', 'placebo', 'nicotine gum with placebo']","['overall abstinence', 'quitting smoking', 'odds of lapsing', 'ecological momentary assessment (EMA']","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1880200', 'cui_str': 'Occasional tobacco smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}]",,0.0231301,"Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo (OR=0.45, 0.22-0.94); when gum was not used, the assigned gum condition made no significant difference (OR=1.53, 0.78-3.01; Bayes Factor=0.14).","[{'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Shiffman', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Scholl', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Hedeker', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15083']
212,31622569,Short-time effect of the kangaroo position on electromyographic activity of premature infants: a randomized clinical trial.,"OBJECTIVE


To verify the short-term influence of the kangaroo position (KP) on the electromyography activity of preterm newborns.
METHOD


A clinical study was conducted in a kangaroo unit sector (secondary and tertiary care) in the city of Recife, Brazil, with 44 preterm infants randomized to intervention (n=21) and control (n=23) groups. The KP was performed through a band that supports the newborn against the adult's thorax, in a prone and vertical position, and infants were dressed with few pieces of clothes, thus keeping skin-to-skin contact with the mother. Surface electromyography was used to investigate the muscle activity of the biceps brachii and hamstrings. The randomization of the groups was performed by the program R® (v. 3.3.1). The electromyography registrations were made at three different times: before the KP and after one and two hours of KP. In the control group, the registrations were performed at the times corresponding to those of the intervention group. The mean values of the electromyography activity among the times were analyzed by ANOVA for repeated measures and the Kruskal-Wallis test. The clinical trial was recorded in ClinicalTrials.gov (NCT02849665 - 07/28/2016).
RESULTS


In the intervention group (n=21), there was a variation of the electromyography activity values between the three recording moments for both the biceps brachii and hamstrings. In the control group (n=23), there was no statistical difference between the recording moments for both.
CONCLUSIONS


The KP increases the short-term electromyographic activity of the biceps brachii and hamstrings.",2020,"In the intervention group (n = 21), there was a variation of the electromyography activity values between the three recording moments for both the biceps brachii and hamstrings.","['premature infants', 'preterm newborns', 'kangaroo unit sector (secondary and tertiary care) in the city of Recife, Brazil, with 44 preterm infants randomized to intervention (n\u202f=\u202f21) and control (n\u202f=\u202f23) groups']","['kangaroo position (KP', 'kangaroo position']","['mean values of the electromyography activity', 'KP increases the short-term electromyographic activity', 'electromyography activity values', 'electromyographic activity']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1510459', 'cui_str': 'Kangaroo'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1510459', 'cui_str': 'Kangaroo'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",,0.0170407,"In the intervention group (n = 21), there was a variation of the electromyography activity values between the three recording moments for both the biceps brachii and hamstrings.","[{'ForeName': 'Kaísa Trovão', 'Initials': 'KT', 'LastName': 'Diniz', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Programa de Pós-Graduação, Recife, PE, Brazil.'}, {'ForeName': 'José Eulálio', 'Initials': 'JE', 'LastName': 'Cabral Filho', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Programa de Pós-Graduação, Recife, PE, Brazil.'}, {'ForeName': 'Rafael Moura', 'Initials': 'RM', 'LastName': 'Miranda', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Programa de Pós-Graduação, Recife, PE, Brazil. Electronic address: rafael.mm@hotmail.com.'}, {'ForeName': 'Geisy Maria Souza', 'Initials': 'GMS', 'LastName': 'Lima', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Recife, PE, Brazil.'}, {'ForeName': 'Natália Priscila Dos Santos', 'Initials': 'NPDS', 'LastName': 'Figueredo', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Recife, PE, Brazil.'}, {'ForeName': 'Kalline Fernanda Nunes de', 'Initials': 'KFN', 'LastName': 'Araújo', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP), Recife, PE, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2019.10.003']
213,32179233,"Posttraumatic stress, stressor controllability, and avoidance.","Cognitive models of posttraumatic stress disorder (PTSD) propose that overgeneralized beliefs involving lack of control are important to development and maintenance of the disorder. In the absence of a strong evidence base regarding controllability in PTSD, we examined whether PTSD was associated with increased sensitivity to alterations in controllability over stressful stimuli. Participants with (PTSD+, n = 113) and without (PTSD-, n = 115) symptoms were recruited from a crowdsourcing platform and randomized to receive either Controllable aversive noise, Uncontrollable aversive noise, or No noise before completing a subsequent aversive noise task in which all participants lost control over aversive noise. Participants then completed an avoidance task that assessed the delay between selecting and viewing a potentially distressing stimulus. PTSD+, but not PTSD-, participants who initially had control over an aversive noise but then lost the control were more avoidant of subsequent distress than those who either did not previously have control over the noise or was not exposed to the noise. Importantly, this pattern was evident in females but not males. These results highlight that people with PTSD are vulnerable to the adverse effects of losing control, and this can contribute to avoidance. The findings that this vulnerability is heightened in females may shed light on the greater risk of females to develop PTSD.",2020,"PTSD+, but not PTSD-, participants who initially had control over an aversive noise but then lost the control were more avoidant of subsequent distress than those who either did not previously have control over the noise or was not exposed to the noise.","['Participants with (PTSD+, n\xa0=\xa0113) and without (PTSD-, n\xa0=\xa0115) symptoms', 'posttraumatic stress disorder (PTSD']","['Controllable aversive noise, Uncontrollable aversive noise, or No noise before completing a subsequent aversive noise task in which all participants lost control over aversive noise', 'PTSD']","['delay between selecting and viewing a potentially distressing stimulus', 'Posttraumatic stress, stressor controllability, and avoidance']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0114729,"PTSD+, but not PTSD-, participants who initially had control over an aversive noise but then lost the control were more avoidant of subsequent distress than those who either did not previously have control over the noise or was not exposed to the noise.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hancock', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'University of New South Wales, Sydney, Australia. Electronic address: r.bryant@unsw.edu.au.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103591']
214,31522896,"The impact of an interactive, multifaceted education approach for congenital cataract on parental anxiety, knowledge and satisfaction: A randomized, controlled trial.","OBJECTIVE


The aim of our research was to examine the impact of a patient education program for parents of children with congenital cataract on parental stress, comprehension of disease information and parental satisfaction.
METHODS


This prospective study included 177 parents of children with congenital cataract. The children were randomized into the following groups: the health education program with a multifaceted, interactive approach and conventional follow-up. Self-administered questionnaires were used for parental evaluation before and after the education program. The anxiety level, parental satisfaction and comprehension of the information were evaluated at each time point.
RESULTS


A multifaceted, interactive approach to education significantly reduced parental levels of anxiety compared with the conventional group (effect sizes: Parenting Stress Index, ƞ2 = 0.285; Ocular Treatment Index, ƞ2 = 0.346). This approach also improved comprehension-memorization scores (effect sizes: ƞ2 = 0.303) and parental satisfaction (p < 0.001). The impact of this new intervention was maintained for 6 and 12 months after the course.
CONCLUSION


The interactive, multifaceted education approach could efficiently improve the comprehension of disease-related information and parental satisfaction, resulting in significantly decreased parental anxiety.
PRACTICE IMPLICATIONS


This new patient education approach had a significant impact on congenital cataracts and may be generalized to other pediatric diseases.",2020,"A multifaceted, interactive approach to education significantly reduced parental levels of anxiety compared with the conventional group (effect sizes: Parenting Stress Index, ƞ2 = 0.285; Ocular Treatment Index, ƞ2 = 0.346).","['parents of children with congenital cataract on parental stress, comprehension of disease information and parental satisfaction', '177 parents of children with congenital cataract']","['interactive, multifaceted education approach', 'health education program with a multifaceted, interactive approach and conventional follow-up', 'patient education program']","['parental levels of anxiety', 'comprehension-memorization scores', 'anxiety level, parental satisfaction and comprehension of the information', 'comprehension of disease-related information and parental satisfaction', 'parental anxiety, knowledge and satisfaction', 'parental satisfaction']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009691', 'cui_str': 'Congenital cataract (disorder)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0018701'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",177.0,0.0875486,"A multifaceted, interactive approach to education significantly reduced parental levels of anxiety compared with the conventional group (effect sizes: Parenting Stress Index, ƞ2 = 0.285; Ocular Treatment Index, ƞ2 = 0.346).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuoling', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lanqin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weirong', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. Electronic address: 1gddlht@aliyun.com.'}]",Patient education and counseling,['10.1016/j.pec.2019.09.002']
215,31537316,Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control.,"OBJECTIVE


To compare differences in patient-provider communication among patients who, prior to contraceptive counseling, used or did not use a decision support tool (""My Birth Control"") which has educational and interactive modules and produces a provider printout with the patient's preferences.
METHODS


As part of a cluster-randomized trial of the tool in four San Francisco safety net clinics, we collected and thematically analyzed 70 audio recordings of counseling visits (31 pre- and 39 post-tool implementation) from 15 providers randomized to the intervention.
RESULTS


Without the tool, most providers began by asking participants what method they were considering and focused counseling on that method or on directing patients towards long-acting reversible contraception; with the tool, most focused on reviewing and discussing multiple methods of interest to the participant as indicated on the printout. Discussion of patients' preferences for specific method features was not observed in pre-implementation recordings but was part of several post-implementation recordings. Several participants explicitly noted they had gained knowledge from the tool.
CONCLUSION


Observed counseling differences suggest the tool may have a positive impact on patient-centeredness of contraceptive counseling, consistent with findings from the main study.
PRACTICE IMPLICATIONS


My Birth Control shows potential for improving patient-centeredness in counseling without extensive provider training.",2020,Discussion of patients' preferences for specific method features was not observed in pre-implementation recordings but was part of several post-implementation recordings.,"['patient-provider communication among patients who, prior to contraceptive counseling, used or did not use a decision support tool (""My Birth Control']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",[],[],70.0,0.0323495,Discussion of patients' preferences for specific method features was not observed in pre-implementation recordings but was part of several post-implementation recordings.,"[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Department of Family & Community Medicine, University of California, San Francisco, USA. Electronic address: Kelsey.Holt@ucsf.edu.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Kimport', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, USA. Electronic address: Katrina.Kimport@ucsf.edu.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, USA. Electronic address: Miriam.Kuppermann@ucsf.edu.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Family & Community Medicine, University of California, San Francisco, USA. Electronic address: judith.fitzpatrick89@gmail.com.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Steinauer', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, USA. Electronic address: Jody.Steinauer@ucsf.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dehlendorf', 'Affiliation': 'Department of Family & Community Medicine, University of California, San Francisco, USA; Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California, San Francisco, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, USA. Electronic address: Christine.Dehlendorf@ucsf.edu.'}]",Patient education and counseling,['10.1016/j.pec.2019.09.003']
216,31543353,Effects of a HAPA-based multicomponent intervention to improve self-management precursors of older adults with tuberculosis: A community-based randomised controlled trial.,"OBJECTIVE


To evaluate the effectiveness of a multicomponent intervention based on the Health Action Process Approach (HAPA) model to improve the self-management precursors of older adults with tuberculosis (TB).
METHODS


A cluster-randomised controlled trial was conducted. Older adults with TB in the intervention communities received HAPA-based multicomponent interventions at the beginning of treatment and in the first and sixth months after treatment initiation, and those in the control communities received health education alone. Self-management precursors were measured at baseline and 1 week after each intervention.
RESULTS


Among 262 randomized patients, 244 (93%) completed the trial. Compared with the control group, self-management precursor scores for the intervention group increased significantly over time (β group*time  = 2.92, p < 0.001) in the following 3 precursors: behaviour belief (β group*time  = 0.35, p < 0.001), behaviour plan (β group*time  = 0.72, p < 0.001), and self-efficacy (β group*time  = 1.85, p < 0.001). Education was significantly associated with behaviour belief (β = 0.18, p < 0.05). Chronic comorbidity was significantly associated with behaviour plan (β=-0.26, p < 0.05).
CONCLUSION


Compared with single health education, the HAPA-based multicomponent interventions significantly improved the self-management precursor of older adults with TB.
PRACTICE IMPLICATIONS


This HAPA-based multicomponent intervention strategy may be a promising self-management mode for the routine health care of TB patients.",2020,"Compared with single health education, the HAPA-based multicomponent interventions significantly improved the self-management precursor of older adults with TB.
","['older adults with tuberculosis', '262 randomized patients, 244 (93%) completed the trial', 'Older adults with TB', 'older adults with tuberculosis (TB', 'older adults with TB', 'TB patients']","['health education alone', 'Health Action Process Approach (HAPA) model', 'HAPA-based multicomponent intervention', 'multicomponent intervention', 'HAPA-based multicomponent interventions']","['behaviour belief', 'Chronic comorbidity', 'self-management precursor scores', 'self-efficacy']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0018701'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",262.0,0.104424,"Compared with single health education, the HAPA-based multicomponent interventions significantly improved the self-management precursor of older adults with TB.
","[{'ForeName': 'Yanshu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Ministry of Education (MOE) Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 2250933517@qq.com.'}, {'ForeName': 'Dixin', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Ministry of Education (MOE) Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: tandixin0907@outlook.co.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Ministry of Education (MOE) Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: xuyihua_6@hotmail.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: m15623339819@163.com.'}, {'ForeName': 'Xuhui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Ministry of Education (MOE) Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 562073458@qq.com.'}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: caixiaonan0415@hotmail.com.'}, {'ForeName': 'Mengyu', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 271754582@qq.com.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 18971114282@qq.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Enshi Tujia and Miao Autonomous Prefecture Centers for Disease Prevention and Control, Department of Infectious Disease, Prevention and Control, Enshi, China. Electronic address: 360053062@qq.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Shu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 109760015@qq.com.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 625585785@qq.com.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Ministry of Education (MOE) Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 1803011149@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Ministry of Education (MOE) Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 184594024@qq.com.'}, {'ForeName': 'Yaqiong', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Wuhan Municipal Center for Disease Control and Prevention, Wuhan, China. Electronic address: 89519752@qq.com.'}, {'ForeName': 'Xunchang', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 1124638901@qq.com.'}, {'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: 9990024636@hust.edu.cn.'}]",Patient education and counseling,['10.1016/j.pec.2019.09.007']
217,32281579,"Short-Term Efficacy (at 12 Weeks) and Long-Term Safety (up to 52 Weeks) of Omega-3 Free Fatty Acids (AZD0585) for the Treatment of Japanese Patients With Dyslipidemia　- A Randomized, Double-Blind, Placebo-Controlled, Phase III Study.","BACKGROUND


This study is the first to evaluate the short-term efficacy and long-term safety of AZD0585, a mixture of omega-3 free fatty acids, in Japanese patients with dyslipidemia.Methods and Results:In this randomized double-blind placebo-controlled Phase III study, 383 patients were randomized to 2 g AZD0585, 4 g AZD0585, or placebo once daily for 52 weeks. Eligible patients had low-density lipoprotein cholesterol (LDL-C) levels controlled regardless of statin use, and triglyceride levels between 150 and 499 mg/dL. The least-squares (LS) mean percentage changes in triglyceride concentrations from baseline to the 12-week endpoint (mean of measurements at Weeks 10 and 12) in the 2 and 4 g AZD0585 and placebo groups were -15.57%, -21.75%, and 11.15% respectively (P<0.0001 for both AZD0585 doses vs. placebo). No clinically significant changes from baseline to the 12-week endpoint in total cholesterol, LDL-C, and LDL-C/apolipoprotein (Apo) B were found with AZD0585. High-density lipoprotein cholesterol (HDL-C) was slightly increased and very low-density lipoprotein cholesterol, non-HDL-C, ApoC-II, and ApoC-III were decreased with AZD0585 compared with placebo at the 12-week endpoint. Lipid profiles up to Week 52 were consistent with those up to the 12-week endpoint. No clinically important safety concerns were raised.
CONCLUSIONS


AZD0585 significantly decreased serum triglyceride levels compared with placebo at the 12-week endpoint and was generally safe and well tolerated in Japanese patients with dyslipidemia.",2020,"No clinically significant changes from baseline to the 12-week endpoint in total cholesterol, LDL-C, and LDL-C/apolipoprotein","['Japanese patients with dyslipidemia', 'Japanese Patients With Dyslipidemia\u3000', '383 patients']","['AZD0585, a mixture of omega-3 free fatty acids', 'AZD0585, 4 g AZD0585, or placebo', 'placebo', 'Omega-3 Free Fatty Acids (AZD0585', 'Placebo']","['serum triglyceride levels', 'High-density lipoprotein cholesterol (HDL-C', 'safe and well tolerated', 'low-density lipoprotein cholesterol, non-HDL-C, ApoC-II, and ApoC-III', 'triglyceride concentrations', 'total cholesterol, LDL-C, and LDL-C/apolipoprotein', 'low-density lipoprotein cholesterol (LDL-C) levels controlled regardless of statin use, and triglyceride levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0245042', 'cui_str': 'apolipoprotein C-II (Toronto)'}, {'cui': 'C4048315', 'cui_str': 'ApoC-III'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",383.0,0.139741,"No clinically significant changes from baseline to the 12-week endpoint in total cholesterol, LDL-C, and LDL-C/apolipoprotein","[{'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Niwa', 'Affiliation': 'Niwa Family Clinic.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Hakoda', 'Affiliation': 'Nippon Kokan Fukuyama Hospital.'}, {'ForeName': 'Fumiki', 'Initials': 'F', 'LastName': 'Oh', 'Affiliation': 'Shindenhigashi Clinic.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kajimoto', 'Affiliation': 'Senrichuo Ekimae Clinic.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Fukui', 'Affiliation': 'Olive Takamatsu Medical Clinic.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research & Development, AstraZeneca K.K.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': 'Research & Development, AstraZeneca K.K.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lundström', 'Affiliation': 'Global Medicine Development, AstraZeneca Gothenburg.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'Research & Development, AstraZeneca K.K.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0358']
218,31421583,Leveraging copresence to increase the effectiveness of gamified personalized normative feedback.,"Virtual copresence, or the sense of being with others in an online space, is a feeling induced on many apps and websites through user avatars and browsable profile pages. Despite the small/modest effect sizes observed in popular web-based personalized normative feedback (PNF) alcohol interventions for college students, previous research has yet to consider how copresence might boost efficacy. This study builds on previous PNF gamification work to investigate whether specific copresence features (visual and text-based information about peers) increase PNF's ability to reduce alcohol use relative to a standard PNF condition and a gamified PNF condition. Copresence and perceptions of drinking norms (average drinks, peak drinks, and binge episodes) were assessed during a 3-week period following random assignment of college students (N = 235) to 1 of the 4 web-based PNF conditions (Standard PNF, Gamified PNF Only, Gamified PNF + Visual Copresence, and Gamified PNF + Maximum Copresence). These conditions asked the same questions about drinking and delivered identical PNF on alcohol use, but differed in the level of visual and text-based information about peers. Overall, only the gamified condition that featured maximum copresence significantly reduced drinking outcomes relative to standard PNF. However, conditional effects were moderated by pre-intervention drinking. Among heavier pre-intervention drinkers, both gamified conditions that featured copresence significantly improved upon Standard PNF in reducing alcohol use at follow-up. Findings suggest that including social media-like copresence features to visually represent and provide basic information about the peers contributing to the norms can enhance the efficacy of gamified PNF interventions, especially among high-risk heavy drinkers.",2019,"Overall, only the gamified condition that featured maximum copresence significantly reduced drinking outcomes relative to standard PNF.",['college students'],"['4 web-based PNF conditions (Standard PNF, Gamified PNF Only, Gamified PNF\u202f+\u202fVisual Copresence, and Gamified PNF\u202f+\u202fMaximum Copresence']","['Copresence and perceptions of drinking norms (average drinks, peak drinks, and binge episodes']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",,0.0406916,"Overall, only the gamified condition that featured maximum copresence significantly reduced drinking outcomes relative to standard PNF.","[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'LaBrie', 'Affiliation': 'Department of Psychology, Loyola Marymount University, 1 LMU Dr., Los Angeles, CA 90045, United States. Electronic address: jlabrie@lmu.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'de Rutte', 'Affiliation': 'Department of Psychology, Loyola Marymount University, 1 LMU Dr., Los Angeles, CA 90045, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Boyle', 'Affiliation': 'Department of Psychology, Loyola Marymount University, 1 LMU Dr., Los Angeles, CA 90045, United States.'}, {'ForeName': 'Cara N', 'Initials': 'CN', 'LastName': 'Tan', 'Affiliation': 'Department of Psychology, Loyola Marymount University, 1 LMU Dr., Los Angeles, CA 90045, United States.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Earle', 'Affiliation': 'Department of Psychology, Loyola Marymount University, 1 LMU Dr., Los Angeles, CA 90045, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106085']
219,32281817,Does alcohol cue inhibitory control training survive a context shift?,"Inhibitory control training (ICT) is a novel psychological intervention that aims to improve inhibitory control in response to alcohol-related cues through associative learning. Laboratory studies have demonstrated reductions in alcohol consumption following ICT compared with control/sham training, but it is unclear if these effects are robust to a change of context. In a preregistered study, we examined whether the effects of ICT would survive a context shift from a neutral context to a seminaturalistic bar setting. In a mixed design, 60 heavy drinkers (40 female) were randomly allocated to receive either ICT or control/sham training in a neutral laboratory over 2 sessions. We developed a novel variation of ICT that used multiple stop signals to establish direct stimulus-stop associations. The effects of ICT/control were measured once in the same context and once following a shift to a novel (alcohol-related) context. Our dependent variables were ad libitum alcohol consumption following training, change in inhibitory control processes, and change in alcohol value. ICT did not reduce alcohol consumption in either context compared with the control group. Furthermore, we demonstrated no effects of ICT on inhibitory control processes or alcohol value. Bayesian analyses demonstrated overall support for the null hypotheses. This study failed to find any effects of ICT on alcohol consumption or candidate psychological mechanisms. These findings illustrate the difficulty in training alcohol-inhibition associations and add to a growing body of literature suggesting that ICT holds little evidential value as a psychological intervention for alcohol use disorders. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,ICT did not reduce alcohol consumption in either context compared with the control group.,['60 heavy drinkers (40 female'],"['ICT or control/sham training', 'Inhibitory control training (ICT', 'ICT']",['alcohol consumption'],"[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0171807,ICT did not reduce alcohol consumption in either context compared with the control group.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baines', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ruddock', 'Affiliation': 'School of Psychology, University of Birmingham.'}, {'ForeName': 'Ingmar', 'Initials': 'I', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus University.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Verbruggen', 'Affiliation': 'Department of Experimental Psychology, Ghent University.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Field', 'Affiliation': 'Department of Psychology, University of Sheffield.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000580']
220,32272288,How and for whom does supportive adjustment to multiple sclerosis cognitive-behavioural therapy work? A mediated moderation analysis.,"The supportive adjustment for multiple sclerosis (saMS) randomised controlled trial showed cognitive behavioural therapy (CBT) reduced distress at 12-months compared to supportive listening (SL). Larger changes in distress and functional impairment following CBT occurred in participants with clinical distress at baseline. This secondary analysis investigates whether CBT treatment effects occur through pre-defined CBT mechanisms of change in the total cohort and clinically distressed subgroup. 94 participants were randomised to saMS CBT or SL. Primary outcomes were distress and functional impairment (12 months). Mediators included cognitive-behavioural variables at post-treatment (15 weeks). Structural equation mediation and mediated-moderation models adjusting for baseline confounders assessed mediation overall and by distress level. Significant mediation was found but only for those with clinical distress at baseline. Illness acceptance (-0.20, 95% confidence interval -0.01 to -0.46) and reduced embarrassment avoidance behaviours (-0.22, -0.02 to -0.58) mediated CBT's effect on distress. Changes in beliefs about processing emotions (-0.19, -0.001 to -0.46) mediated CBT's effect on functional impairment. saMS CBT had effects on distress and functional impairment via some of the hypothesised mechanisms drawn from a theoretical model of adjustment for MS but only among participants with clinical distress at baseline. Increasing acceptance and emotional expression and decreasing embarrassment avoidance improves MS adjustment.",2020,"Changes in beliefs about processing emotions (-0.19, -0.001 to -0.46) mediated CBT's effect on functional impairment.",['94 participants'],"['saMS CBT or SL', 'CBT', 'cognitive behavioural therapy', 'saMS CBT']","['embarrassment avoidance behaviours', 'Increasing acceptance and emotional expression and decreasing embarrassment avoidance improves MS adjustment', 'cognitive-behavioural variables', 'distress and functional impairment', 'beliefs about processing emotions', 'Illness acceptance', ""CBT's effect on distress""]",[],"[{'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",94.0,0.242501,"Changes in beliefs about processing emotions (-0.19, -0.001 to -0.46) mediated CBT's effect on functional impairment.","[{'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""King's College London, Department of Biostatistics & Informatics, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': ""King's College London, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Psychological Medicine Department, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dennison', 'Affiliation': 'Department of Psychology, University of Southampton, Highfield Campus, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""King's College London, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, De Crespigny Park, London, SE5 8AF, UK. Electronic address: rona.moss-morris@kcl.ac.uk.""}]",Behaviour research and therapy,['10.1016/j.brat.2020.103594']
221,31394990,Message Framing and the Willingness to Pursue Behavioral Therapy: A Study of People With Migraine.,"OBJECTIVE


Behavioral treatments for migraine prevention are safe and effective but underutilized in migraine management. Health message framing may be helpful in guiding patients with treatment decision making. The authors assessed associations between message framing and the willingness to seek migraine behavioral treatment among persons with a diagnosis of migraine headache.
METHODS


A total of 401 individuals (median age=34 years [interquartile range, 12 years]) who screened positive for migraine, as determined by the American Migraine Prevalence and Prevention questionnaire, were assessed. Participants were randomly assigned to receive one of four message frames using TurkPrime: specific loss framing (N=101), specific gain framing (N=98), nonspecific loss framing (N=102), and nonspecific gain framing (N=100). The message frames were initially piloted for 56 participants and then revised by a headache specialist, with input from a communications specialist, and randomly distributed to the larger sample.
RESULTS


More than two-thirds of participants (70.3%) were women. The median number of headache days per month was 5 (interquartile range, 5.3). Some of the participants (12.5%) had previously used evidence-based behavioral therapy for migraine. No significant differences in the willingness to pursue behavioral treatment for migraine between the four message framing groups were found. The median for all four types of message frames was 4 (interquartile range, 1; Kruskal-Wallis H, p=0.41).
CONCLUSIONS


Findings revealed that message framing was not associated with willingness to seek behavioral therapy for migraine.",2020,No significant differences in the willingness to pursue behavioral treatment for migraine between the four message framing groups were found.,"['56 participants and then revised by a headache specialist, with input from a communications specialist, and randomly distributed to the larger sample', 'People With Migraine', 'persons with a diagnosis of migraine headache', '401 individuals (median age=34 years [interquartile range, 12 years]) who screened positive for migraine, as determined by the American Migraine Prevalence and Prevention questionnaire, were assessed']","['TurkPrime: specific loss framing (N=101), specific gain framing (N=98), nonspecific loss framing (N=102), and nonspecific gain framing', 'Message Framing and the Willingness to Pursue Behavioral Therapy']","['willingness to pursue behavioral treatment for migraine', 'median number of headache']","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",401.0,0.0587865,No significant differences in the willingness to pursue behavioral treatment for migraine between the four message framing groups were found.,"[{'ForeName': 'Adama', 'Initials': 'A', 'LastName': 'Jalloh', 'Affiliation': 'The Department of Psychology, City College of the City University of New York (Jalloh); the Department of Neurology, Columbia University Medical Center, New York (Begasse de Dhaem); the Department of Neurology, Yeshiva University Albert Einstein College of Medicine, Bronx, N.Y. (Seng); and the Department of Neurology and Department of Population Health, New York University (Minen).'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Begasse de Dhaem', 'Affiliation': 'The Department of Psychology, City College of the City University of New York (Jalloh); the Department of Neurology, Columbia University Medical Center, New York (Begasse de Dhaem); the Department of Neurology, Yeshiva University Albert Einstein College of Medicine, Bronx, N.Y. (Seng); and the Department of Neurology and Department of Population Health, New York University (Minen).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Seng', 'Affiliation': 'The Department of Psychology, City College of the City University of New York (Jalloh); the Department of Neurology, Columbia University Medical Center, New York (Begasse de Dhaem); the Department of Neurology, Yeshiva University Albert Einstein College of Medicine, Bronx, N.Y. (Seng); and the Department of Neurology and Department of Population Health, New York University (Minen).'}, {'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'The Department of Psychology, City College of the City University of New York (Jalloh); the Department of Neurology, Columbia University Medical Center, New York (Begasse de Dhaem); the Department of Neurology, Yeshiva University Albert Einstein College of Medicine, Bronx, N.Y. (Seng); and the Department of Neurology and Department of Population Health, New York University (Minen).'}]",The Journal of neuropsychiatry and clinical neurosciences,['10.1176/appi.neuropsych.19030056']
222,30661702,Associations of vitamin D binding protein variants with the vitamin D-induced increase in serum 25-hydroxyvitamin D.,"BACKGROUND


Vitamin D deficiency is a global problem that may be improved by vitamin D supplementation; however, the individual's response to the intervention varies. We aimed to investigate possible genetic factors that may modify the impact of environmental exposure on vitamin D status. The candidate gene variant we investigated was the Gc gene-rs4588 polymorphism at the vitamin D receptor (DBP) locus.
METHODS


A total of 619 healthy adolescent Iranian girls received 50000 IU of vitamin D 3  weekly for 9 weeks. Serum 25(OH) D concentrations, metabolic profiles and dietary intake were measured at baseline and after 9 weeks of supplementation. The genotypes of the DBP variant (rs4588) were analyzed using the TaqMan genotyping assay.
RESULTS


Our results revealed that the rs4588 polymorphism might be associated with serum 25-hydroxy vitamin D both at baseline (p value = 0.03) and after intervention (p value = 0.008). It seemed that the outcome of the intervention was gene-related so that the subjects with common AA genotype were a better responder to vitamin D supplementation (Changes (%) 469.5 (427.1) in AA carriers vs. 335.8 (530) in GG holders), and carriers of the less common GG genotype experienced a rise in fasting blood glucose after 9 weeks (Changes (%) 0 (1.5)). Our findings also showed that the statistical interaction between this variant and supplementation was statistically significant (intervention effect p-value<0.001 and p-value SNP effect = 0.03). The regression model also revealed that after adjusted for potential confounders, likelihood of affecting serum 25(OH)D in individuals who were homozygous for the uncommon allele G was less than those homozygous for the more common AA genotype (OR = 4.407 (1.82-8.89); p = 0.001).
CONCLUSION


Serum vitamin 25(OH) D following vitamin 25(OH) D 3  supplementation appears to be modified by genetic background. The Gc genetic variant, rs4588 encoding the vitamin D receptor seems to influence the response to vitamin D supplementation.",2019,"The candidate gene variant we investigated was the Gc gene-rs4588 polymorphism at the vitamin D receptor (DBP) locus.
",['619 healthy adolescent Iranian girls'],"['Serum vitamin 25(OH', 'vitamin 25(OH', 'vitamin D']","['serum 25-hydroxyvitamin D', 'Serum 25(OH', 'D concentrations, metabolic profiles and dietary intake', 'serum 25-hydroxy vitamin D', 'fasting blood glucose']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0428581', 'cui_str': 'Serum vitamin A measurement'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",619.0,0.106931,"The candidate gene variant we investigated was the Gc gene-rs4588 polymorphism at the vitamin D receptor (DBP) locus.
","[{'ForeName': 'Mehrane', 'Initials': 'M', 'LastName': 'Mehramiz', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Modern Sciences and Technologies, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sayyed Saeid', 'Initials': 'SS', 'LastName': 'Khayyatzadeh', 'Affiliation': 'Nutrition and Food Security Research Centre, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': 'Social Determinants of Health Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Ghasemi', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Sadeghi-Ardekani', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tayefi', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Jamal', 'Initials': 'SJ', 'LastName': 'Mirmousavi', 'Affiliation': 'Community Medicine, Community Medicine Department, Medical School, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Parichehr', 'Initials': 'P', 'LastName': 'Hanachi', 'Affiliation': 'Department of Biology, Biochemistry Unit, Al Zahra University, Tehran, IR Iran.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bahrami-Taghanaki', 'Affiliation': 'Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Eslami', 'Affiliation': 'Chinese and Complementary Medicine Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Vatanparast', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Health Sciences E-Wing, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Ferns', 'Affiliation': 'Brighton & Sussex Medical School, Division of Medical Education, Falmer, Brighton, Sussex BN1 9PH, UK.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour-Mobarhan', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: ghayourm@mums.ac.ir.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Avan', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Modern Sciences and Technologies, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: avana@mums.ac.ir.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2018.12.005']
223,32271452,Vitamin D plus epigallocatechin gallate: a novel promising approach for uterine myomas.,"OBJECTIVE


Uterine myomas are the most common benign tumors in females. Most myomas are asymptomatic and require no intervention or further investigations; however, almost a third of women with myomas will require a therapy. Treatment options include pharmacological approaches or surgery, and depend on symptomatology, size, number and desire for future pregnancy. Minimally invasive procedures or alternative medical treatments for handling myomas are preferred, when possible, to the radical abdominal surgery. Vitamin D and epigallocatechin gallate (EGCG) recently proved effective in the management of these benign tumors. Our aim was to verify the effect of combined oral vitamin D and EGCG supplementation in symptomatic women with myomas.
PATIENTS AND METHODS


Symptomatic women with myomas were enrolled in this pilot study and divided in two groups: one group treated daily with two tablets of 25 μg vitamin D + 150 mg EGCG + 5 mg vitamin B6, for 4 months; the other group received no treatment (control), for the same period. Volume, number of myomas as well as severity of symptoms (SS) and quality of life (QoL) were analyzed.
RESULTS


The total myoma volume significantly decreased by 34.7% in the treated group, whereas it increased by 6.9% in the control group. An improvement in the QoL of women treated with vitamin D, EGCG and vitamin B6 was reported along with a reduction of the SS.
CONCLUSIONS


The combined supplementation of vitamin D and EGCG seems to be an optimal approach for the management of myomas and correlated symptoms. For the first time, we showed the cooperative effectiveness as a promising and novel treatment for myomas.",2020,"The total myoma volume significantly decreased by 34.7% in the treated group, whereas it increased by 6.9% in the control group.","['symptomatic women with myomas', 'Symptomatic women with myomas', 'uterine myomas']","['25 μg vitamin D + 150 mg EGCG + 5 mg vitamin B6, for 4 months; the other group received no treatment (control', 'Vitamin D plus epigallocatechin gallate', 'Vitamin D and epigallocatechin gallate (EGCG', 'vitamin D and EGCG', 'combined oral vitamin D and EGCG supplementation', 'vitamin D, EGCG and vitamin B6']","['Volume, number of myomas as well as severity of symptoms (SS) and quality of life (QoL', 'total myoma volume']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0843492,"The total myoma volume significantly decreased by 34.7% in the treated group, whereas it increased by 6.9% in the control group.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Porcaro', 'Affiliation': 'Department of Obstetric and Gynecology, Hospital Santa Maria della Stella Orvieto USL Umbria 2, Orvieto, Italy. giusy.porcaro@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santamaria', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Giordano', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Angelozzi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202003_20702']
224,32278340,One-year clinical outcomes following non-surgical treatment of peri-implant mucositis with adjunctive diode laser application.,"BACKGROUND


Limited information is available on the application of diode laser in the treatment of peri-implant diseases. The aim of this study was to investigate the clinical efficacy of the adjunctive application of diode laser in the non-surgical treatment of peri-implant mucositis during a 12-month follow-up period.
METHODS


The sample was composed of 73 systemically healthy patients with one implant diagnosed with peri-implant mucositis (bleeding on probing [BoP] with no loss of supporting bone). Implants were randomly assigned to mechanical debridement with hand and powered instruments and 980-nm diode laser application (test group, N.=38) or mechanical debridement alone (control group, N.=35). At the completion of active treatment patients were included in a periodontal maintenance program. Recalls were provided every three months in both treatment groups for reinforcement in oral hygiene instructions and professional implant cleaning with rubber cups. Baseline parameters were repeated at 3 and 12 months postoperatively.
RESULTS


Intragroup analysis showed that plaque index, BoP and probing depth presented statistically significant improvements when compared with baseline values (all P<0.001). No statistically significant difference in clinical outcomes was observed between treatment groups at each time point. At 12 months no significant difference in the percentage of sites showing BoP resolution was observed between test (60.9%) and control treatment (52.6%), as well.
CONCLUSIONS


Based on the present results, the adjunct use of diode laser showed little but not statistically significant additional benefits in the treatment of peri-implant mucositis after an observation period of one year.",2020,"RESULTS


Intragroup analysis showed that plaque index, BoP and probing depth presented statistically significant improvements when compared with baseline values (all P <0.001).",['73 systemically healthy patients with one implant diagnosed with peri-implant mucositis (bleeding on probing [BoP] with no loss of supporting bone'],"['adjunctive diode laser application', 'diode laser', 'mechanical debridement with hand and powered instruments and 980-nm diode laser application (test group, N= 38) or mechanical debridement alone (control']","['peri-implant mucositis', 'plaque index, BoP and probing depth', 'clinical outcomes', 'percentage of sites showing BoP resolution', 'peri- implant mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2945843', 'cui_str': 'Site of'}]",73.0,0.0278476,"RESULTS


Intragroup analysis showed that plaque index, BoP and probing depth presented statistically significant improvements when compared with baseline values (all P <0.001).","[{'ForeName': 'Giulia M', 'Initials': 'GM', 'LastName': 'Mariani', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ercoli', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Guzzi', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Bongiovanni', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bianco', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Romano', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy - federica.romano@unito.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Aimetti', 'Affiliation': 'Section of Periodontology, C.I.R. Dental School, Department of Surgical Sciences, University of Turin, Turin, Italy.'}]",Minerva stomatologica,['10.23736/S0026-4970.20.04340-X']
225,30550775,Design and methodology of a cluster-randomized trial in early care and education centers to meet physical activity guidelines: Sustainability via Active Garden Education (SAGE).,"Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children. This manuscript describes the design and methodology of Sustainability via Active Garden Education (SAGE), a 12-session cluster-randomized controlled crossover design trial using community-based participatory research (CBPR) to test a garden-based ECEC physical activity and fruit and vegetables promotion intervention for young children aged 3-5 years in 20 sites. The SAGE curriculum uses the plant lifecycle as a metaphor for human development. Children learn how to plant, water, weed, harvest, and do simple food preparation involving washing, cleaning, and sampling fruit and vegetables along with active learning songs, games, science experiments, mindful eating exercises, and interactive discussions to reinforce various healthy lifestyle topics. Parents will receive newsletters and text messages linked to the curriculum, describing local resources and events, and to remind them about activities and assessments. Children will be measured on physical activity, height, and weight and observed during meal and snack times to document dietary habits. Parents will complete measures about dietary habits outside of the ECEC, parenting practices, home physical activity resources, and home fruit and vegetable availability. SAGE fills an important void in the policy literature by employing a participatory strategy to produce a carefully crafted and engaging curriculum with the goal of meeting health policy guidelines and educational accreditation standards. If successful, SAGE may inform and inspire widespread dissemination and implementation to reduce health disparities and improve health equity.",2019,Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children.,"['young children', 'young children aged 3-5\u202fyears in 20 sites']","['community-based participatory research (CBPR) to test a garden-based ECEC physical activity and fruit and vegetables promotion intervention', 'mindful eating exercises, and interactive discussions to reinforce various healthy lifestyle topics', 'SAGE', 'Sustainability via Active Garden Education (SAGE']","['physical activity, height, and weight']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C1122976', 'cui_str': 'Sage (substance)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.0361769,Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children.,"[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Lee', 'Affiliation': 'Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States. Electronic address: releephd@yahoo.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lorenzo', 'Affiliation': 'Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Szeszulski', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Anel', 'Initials': 'A', 'LastName': 'Arriola', 'Affiliation': 'Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bruening', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Southwest Interdisciplinary Research Center, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Teresia', 'Initials': 'T', 'LastName': ""O'Connor"", 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, TX, United States.""}, {'ForeName': 'Kim Sellers', 'Initials': 'KS', 'LastName': 'Pollins', 'Affiliation': 'Booker T. Washington Early Childhood Learning Center, Phoenix, AZ, United States.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Soltero', 'Affiliation': 'Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Center for Health Promotion and Disease Prevention, College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.12.003']
226,31981645,Use of rapid reading software to reduce capsule endoscopy reading times while maintaining accuracy.,"BACKGROUNDS AND AIMS


A typical capsule endoscopy (CE) case generates tens of thousands of images, with abnormalities often confined to a just few frames. Omni Mode is a novel EndoCapsule software algorithm (Olympus, Tokyo, Japan) that proposes to intelligently remove duplicate images while maintaining accuracy in lesion detection.
METHODS


This prospective multicenter study took place across 9 European centers. Consecutive, unselected CE cases were read conventionally in normal mode, with every captured frame reviewed. Cases were subsequently anonymized and randomly allocated to another center where they were read using Omni Mode. Detected lesions and reading times were recorded, with findings compared between both viewing modes. The clinical significance of lesions was described according to the P classification (P0, P1, and P2). Where a discrepancy in lesion detection in either mode was found, expert blinded review at a consensus meeting was undertaken.
RESULTS


The patient population undergoing CE had a mean age of 49.5 years (range, 18-91), with the investigation of anemia or GI bleeding accounting for 71.8% of cases. The average small-bowel transit time was 4 hours, 26 minutes. The mean reading time in normal mode was 42.5 minutes. The use of Omni Mode was significantly faster (P < .0001), with an average time saving of 24.6 minutes (95% confidence interval, 22.8-26.9). The 2127 lesions were identified and classified according to the P classification as P0 (1234), P1 (656), and P2 (237). Lesions were identified using both reading modes in 40% (n = 936), and 1186 lesions were identified by either normal or Omni Mode alone. Normal mode interpretation was associated with 647 lesions being missed, giving an accuracy of .70. Omni Mode interpretation led to 539 lesions being missed, with an accuracy of .75. There was no significant difference in clinical conclusions made between either reading mode.
CONCLUSIONS


This study shows that CE reading times can be reduced by an average of 40%, without any reduction in clinical accuracy.",2020,"The use of Omni Mode was significantly faster (P<0.0001), with an average time saving of 24.6 minutes (95% CI, 22.8 - 26.9).A total of 2172 lesions were identified, which were classified according to the P-classification as P0 (1234), P1 (656), and P2 (237).","['patient population undergoing capsule endoscopy had a mean age of 49.5 years (range 18 - 91), with the investigation of anemia or gastrointestinal bleeding accounting for 71.8% of cases']",[],"['Detected lesions and reading time', 'mean reading time', 'average small-bowel transit time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1721048', 'cui_str': 'Video Capsule Endoscopy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0000938', 'cui_str': 'Accounting'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",[],"[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}]",2172.0,0.0242448,"The use of Omni Mode was significantly faster (P<0.0001), with an average time saving of 24.6 minutes (95% CI, 22.8 - 26.9).A total of 2172 lesions were identified, which were classified according to the P-classification as P0 (1234), P1 (656), and P2 (237).","[{'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Beg', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom; Nottingham Digestive Diseases Centre, The University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wronska', 'Affiliation': 'Department of Gastroenterology, Hepatology and Oncology, Center of Postgraduate Medical Education, Warsaw, Poland; Department of Gastroenterological Oncology, Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Isis', 'Initials': 'I', 'LastName': 'Araujo', 'Affiliation': 'Gastroenterology Department, ICMDiM, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Begona', 'Initials': 'B', 'LastName': 'González Suárez', 'Affiliation': 'Gastroenterology Department, ICMDiM, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Ivanova', 'Affiliation': 'Department of Gastroenterology, Moscow University Hospital N31, Pirogov Russia National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Fedorov', 'Affiliation': 'Department of Gastroenterology, Moscow University Hospital N31, Pirogov Russia National Research Medical University, Moscow, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Aabakken', 'Affiliation': 'Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Seitz', 'Affiliation': 'Department of Gastroenterology, University Hospital Heidelberg, Heppenheim, Germany.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Rey', 'Affiliation': 'Hepato-Gastroenterology Department, Institut Arnault Tzanck, St. Laurent du Var, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Saurin', 'Affiliation': 'Department of Endoscopy and Gastroenterology, Pavillon L, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tari', 'Affiliation': 'Gastroenterology Division, Azienda Ospedaliero Universitaria ""Maggiore della Carità"", Novara, Italy.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Card', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom; Division of Epidemiology and Public Health, School of Medicine The University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Ragunath', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom; Nottingham Digestive Diseases Centre, The University of Nottingham, Nottingham, United Kingdom.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.01.026']
227,32043473,Septic patients with cancer: Do prehospital antibiotics improve survival? A sub-analysis of the PHANTASi trial.,"BACKGROUND


Sepsis in patients with cancer is increasingly common and associated with high mortality. To date, no studies have examined the effectiveness of prehospital antibiotics in septic patients with cancer. This study aimed without and to evaluate the effect of prehospital antibiotics in septic patients with cancer.
METHODS


We conducted a post-hoc sub-analysis of the PHANTASi (PreHospital ANTibioitcs Against Sepsis) trial database: a randomised controlled trial which enrolled patients with suspected sepsis who were transported to the emergency department by ambulance. Patients in the intervention group were administered prehospital intravenous antibiotics while those in the control group received usual care. We compared patients who had cancer to those who did not. Primary outcome was 28-day mortality; among the secondary outcomes, we included in-hospital mortality and 90-day mortality.
RESULTS


357(13.4%) of the 2658 included patients had cancer in the past five years, of which, 209 (58.5%) were included in the intervention and 148 (41.5%) usual care groups; 28-day mortality was significantly higher in patients who were diagnosed with cancer in the past five years than those without cancer in the past five years: 15.2% vs. 7.1%, respectively (p < 0.001). Prehospital antibiotics in the group of patients with cancer in the last five years yielded no significant effect on survival. There were however, significantly fewer 30-day readmissions (p = 0.031) in the intervention group of cancer patients (12.2% vs 5.7%).
CONCLUSION


Prehospital antibiotics did not improve overall survival. However, there was a significant reduction in 30-day readmissions.",2020,"There were however, significantly fewer 30-day readmissions (p = 0.031) in the intervention group of cancer patients (12.2% vs 5.7%).
","['Septic patients with cancer', 'enrolled patients with suspected sepsis who were transported to the emergency department by ambulance', 'patients who had cancer to those who did not', 'patients with cancer', 'septic patients with cancer']","['usual care', 'prehospital antibiotics', 'PHANTASi (PreHospital ANTibioitcs Against Sepsis', 'prehospital intravenous antibiotics']","['hospital mortality and 90-day mortality', 'survival', '30-day readmissions', 'overall survival', '28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2658.0,0.195409,"There were however, significantly fewer 30-day readmissions (p = 0.031) in the intervention group of cancer patients (12.2% vs 5.7%).
","[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Nannan Panday', 'Affiliation': 'Section Acute Medicine, Department of Internal Medicine, Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Schermer', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cooksley', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': ''}, {'ForeName': 'P W B', 'Initials': 'PWB', 'LastName': 'Nanayakkara', 'Affiliation': ''}]",The Netherlands journal of medicine,[]
228,32273125,Antioxidant Vitamins for Cataracts: 15-Year Follow-up of a Randomized Trial.,,2020,,['Cataracts'],['Antioxidant Vitamins'],[],"[{'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}]",[],,0.103686,,"[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Aravind Eye Care System, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Ravilla Duraisami', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Division of Epidemiology, School of Public Health, University of California, Berkeley, California.'}, {'ForeName': 'Usha R', 'Initials': 'UR', 'LastName': 'Kim', 'Affiliation': 'Aravind Eye Care System, Madurai, Tamil Nadu, India.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wilkins', 'Affiliation': 'Casey Eye Institute, Oregon Health Sciences University and Lions VisionGift, Portland, Oregon.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Whitcher', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California; Department of Epidemiology & Biostatistics, University of California, San Francisco, California; Institute for Global Health, University of California, San Francisco, California.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Gritz', 'Affiliation': 'Johns Hopkins Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. Electronic address: jeremy.keenan@ucsf.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.050']
229,32279446,Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2.,"BACKGROUND & AIMS


Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH-2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha-fetoprotein (AFP) ≥400 ng/mL showed an overall ssurvival (OS) benefit for ramucirumab. These post-hoc analyses examined efficacy and safety of ramucirumab in patients with HCC and baseline AFP ≥ 400 ng/mL by three prespecified age subgroups (<65, ≥65 to <75 and ≥75 years).
METHODS


Individual patient data were pooled from REACH (baseline AFP ≥400 ng/mL) and REACH-2. Kaplan-Meier and Cox proportional hazards regression methods (stratified by study) assessed OS, progression-free survival (PFS), time to progression (TTP) and patient-reported outcomes (Functional Hepatobiliary System Index-8 [FHSI-8] score).
RESULTS


A total of 542 patients (<65 years: n = 302; ≥65 to <75 years: n = 160; ≥75 years: n = 80) showed similar baseline characteristics between ramucirumab and placebo. Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup. Ramucirumab prolonged OS in patients <65 years (hazard ratio [HR], 0.753; 95% CI 0.581-0.975), ≥65 to <75 years (0.602; 0.419-0.866) and ≥75 years (0.709; 0.420-1.199), PFS and TTP irrespective of age. Ramucirumab showed similar overall safety profiles across subgroups, with a consistent median relative dose intensity ≥97.8%. A trend towards a delay in symptom deterioration in FHSI-8 with ramucirumab was observed in all subgroups.
CONCLUSIONS


In this post-hoc analysis, ramucirumab showed a survival benefit across age subgroups with a tolerable safety profile, supporting its use in advanced HCC with elevated AFP, irrespective of age, including ≥75 years.",2020,"Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup.","['patients with HCC and baseline AFP ≥400 ng/mL by three prespecified age subgroups (<65, ≥65 to <75, ≥75 years', 'patients with HCC after prior', 'elderly patients with hepatocellular carcinoma', 'elderly patients with hepatocellular carcinoma (HCC', '542 patients (<65 years: n = 302; ≥65 to <75 years: n = 160; ≥75 years: n = 80']","['ramucirumab', 'sorafenib', 'ramucirumab and placebo', 'Ramucirumab']","['hepatitis C and steatohepatitis incidences, and lower AFP levels', 'overall survival (OS) benefit', 'Ramucirumab prolonged OS', 'survival benefit', 'OS, progression-free survival (PFS), time to progression (TTP), and patient-reported outcomes (Functional Hepatobiliary System Index-8 [FHSI-8] score', 'overall safety profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C2711227', 'cui_str': 'Steatohepatitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428521', 'cui_str': 'Alpha-fetoprotein level - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",542.0,0.134624,"Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'Department of Internal Medicine, Mainz University Medical Center, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': 'Translational Research in Hepatic Oncology Group, Liver Unit, IDIBAPS, Hospital Clinic Barcelona, University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Vogel', 'Affiliation': 'Department of Hepatology, Gastroenterology and Endocrinology, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Motomura', 'Affiliation': 'Department of Hepatology, Aso Iizuka Hospital, Fukuoka, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'Department of Medical Oncology, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Hepatology and Gastroenterology Unit, Croix-Rousse Hospital, Northern Lyon Hospital Group, Lyon, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Brandi', 'Affiliation': 'Department of Experimental, Diagnostic and Speciality Medicicne, University Hospital S.Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Department of Oncology, Azienda Ospedaliera Gaetano Rummo, Benevento, Italy.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Tomášek', 'Affiliation': 'Department of Complex Oncology Care, Masaryk Memorial Cancer Institute, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Dadduzio', 'Affiliation': 'Department of Clinical and Experimental Oncology, Medical Oncology Unit-1, Veneto Institute of Oncology (IOV) - IRCCS, Padua, Italy.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pracht', 'Affiliation': 'Department of Medical Oncology, Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Min-Hua', 'Initials': 'MH', 'LastName': 'Jen', 'Affiliation': 'Global Statistical Sciences, Eli Lilly and Company, Surrey, UK.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Drove Ubreva', 'Affiliation': 'Medicines Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Widau', 'Affiliation': 'Oncology, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Medicines Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Reigetsu', 'Initials': 'R', 'LastName': 'Yoshikawa', 'Affiliation': 'Medicines Development Unit Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14462']
230,32279471,Therapeutic Efficacy of the Modified Epley Maneuver With a Pillow Under the Shoulders.,"OBJECTIVES


Canalolithiasis of the posterior semicircular canal (PC) is the most common reason for benign paroxysmal positional vertigo (BPPV). If a patient is diagnosed with PC-BPPV through the Dix-Hallpike test, the modified Epley maneuver (mEpley) is used as the gold standard treatment. To reduce the discomfort of the standard mEpley, we proposed placing a pillow under the shoulders during this therapeutic maneuver. The purpose of this study was to determine whether the therapeutic efficacy of the mEpley with a pillow under the shoulders (mEpley-PS) was comparable to that of the standard mEpley.
METHODS


A randomized controlled study at three academic referral hospitals was conducted in compliance with the CONSORT statement. Patients who were diagnosed with PC-BPPV through the Dix-Hallpike test were randomly assigned to groups A or B. Patients in groups A and B were treated with the standard mEpley and mEpley-PS, respectively. The resolution of vertigo and nystagmus on the Dix-Hallpike test at a 1-week follow-up after treatment was the main outcome measurement to assess the efficacy of treatment.
RESULTS


Forty-one patients diagnosed with PC-BPPV were enrolled in this study. Twenty-one patients were assigned to group A and 20 were assigned to group B. The success rate at 1 week after treatment was 85.7% in group A and 80.0% in group B. There was no statistically significant difference between the two groups (P=0.697).
CONCLUSION


The therapeutic efficacy of the mEpley-PS was comparable to that of the standard mEpley. The use of the pillow modification may be an excellent alternative if a patient cannot tolerate the head-hanging position, and it is helpful for patients who have anxiety about the head-hanging position. The mEpley-PS can be performed on a bed with or without a headboard. It is both a patient-friendly and a clinician-friendly maneuver.",2020,The success rate at 1 week after treatment was 85.7% in group A and 80.0% in group B.,"['Patients who were diagnosed with PC-BPPV through the Dix-Hallpike test', 'Results\n\n\nForty-one patients diagnosed with PC-BPPV', 'three academic referral hospitals was conducted in compliance with the CONSORT statement', 'patients who have anxiety about the head-hanging position']","['Modified Epley Maneuver', 'posterior semicircular canal (PC']","['therapeutic efficacy', 'Therapeutic Efficacy', 'success rate', 'resolution of vertigo and nystagmus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0229454', 'cui_str': 'Structure of posterior semicircular duct'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0444392', 'cui_str': 'Hanging position'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1279393', 'cui_str': 'Epley maneuver'}, {'cui': 'C0229454', 'cui_str': 'Structure of posterior semicircular duct'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus'}]",21.0,0.0715961,The success rate at 1 week after treatment was 85.7% in group A and 80.0% in group B.,"[{'ForeName': 'Hyun Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Eun-Ju', 'Initials': 'EJ', 'LastName': 'Jeon', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Dong-Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ""Department of Otorhinolaryngology-Head and Neck Surgery, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea.""}, {'ForeName': 'Jae-Hyun', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Clinical and experimental otorhinolaryngology,['10.21053/ceo.2019.01830']
231,32271407,Lnc-RNA BLACAT1 regulates differentiation of bone marrow stromal stem cells by targeting miR-142-5p in osteoarthritis.,"OBJECTIVE


Osteogenic differentiation of bone marrow stromal stem cells (BMSCs) is beneficial to the treatment of osteoarthritis (OA). Lnc-RNA BLACAT1 involves in occurrence and development of various diseases. However, the role of Lnc-RNA BLACAT1 in BMSCs differentiation under inflammation remains unclear.
MATERIALS AND METHODS


Rat BMSCs were isolated and randomly divided into control group and inflammation group (addition of IL-6). The inflammation group was further divided into BLACAT1 siRNA group and BLACAT1 siRNA+miR-142-5p inhibitor group, followed by analysis of Lnc-RNA BLACAT1 expression by real time PCR, BMSCs proliferation, Caspase 3 activity, ALP activity, expression of Runx2, OC and PPARγ2 by real time PCR, and secretion of TNF-α and IL-1β by enzyme-linked immunosorbent assay (ELISA). The bioinformatics software and the Luciferase reporter system analyze the targeted relationship between BLACAT1 and miR-142-5p.
RESULTS


In inflammation group, Lnc-BLACAT1 expression was increased, along with inhibited BMSCs proliferation, increased Caspase 3 activity, decreased ALP activity, and expression of Runx2 and OC, increased PPARγ2 expression and secretion of TNF-α and IL-1β. The difference was statistically significant compared with control group (p<0.05). MiR-142-5p is the target miRNA of Lnc-RNA BLACAT1. BLACAT1 siRNA down-regulated BLACAT1 expression, promoted cell proliferation, inhibited Caspase 3 activity, increased ALP activity and Runx2 and OC expression, decreased PPARγ2 expression and TNF-α and IL-1β secretion. Compared with inflammation group, the difference was statistically significant (p<0.05). Of note, BLACAT1 siRNA+miR-142-5p inhibitor group reversed the effect of siRNA-mediated knockdown of BLACAT1.
CONCLUSIONS


Lnc-RNA BLACAT1 expression was increased in inflammatory BMSCs, and knockdown of BLACAT1 promoted proliferation and osteogenic differentiation of BMSCs targeting miR-142-5p.",2020,"BLACAT1 siRNA down-regulated BLACAT1 expression, promoted cell proliferation, inhibited Caspase 3 activity, increased ALP activity and Runx2 and OC expression, decreased PPARγ2 expression and TNF-α and IL-1β secretion.","['Rat BMSCs', 'osteoarthritis (OA']","['bone marrow stromal stem cells (BMSCs', 'control group and inflammation group (addition of IL-6']","['ALP activity and Runx2 and OC expression, decreased PPARγ2 expression and TNF-α and IL-1β secretion', 'BMSCs proliferation, Caspase 3 activity, ALP activity, expression of Runx2, OC and PPARγ2 by real time PCR, and secretion of TNF-α and IL-1β by enzyme-linked immunosorbent assay (ELISA', 'Lnc-BLACAT1 expression', 'inhibited BMSCs proliferation, increased Caspase 3 activity, decreased ALP activity, and expression of Runx2 and OC, increased PPARγ2 expression and secretion of TNF-α and IL-1β', 'bone marrow']","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C4551909', 'cui_str': 'Bone marrow stromal stem cell'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1529564', 'cui_str': 'RUNX2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0291573', 'cui_str': 'Caspase-3'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C1136323', 'cui_str': 'LOINC'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}]",,0.020733,"BLACAT1 siRNA down-regulated BLACAT1 expression, promoted cell proliferation, inhibited Caspase 3 activity, increased ALP activity and Runx2 and OC expression, decreased PPARγ2 expression and TNF-α and IL-1β secretion.","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Hand Surgery, Yantaishan Hospital, Yantai, Shandong, China. maoyi29083206@126.com.'}, {'ForeName': 'Q-Y', 'Initials': 'QY', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'S-N', 'Initials': 'SN', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Z-W', 'Initials': 'ZW', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Z-J', 'Initials': 'ZJ', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'J-N', 'Initials': 'JN', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'S-Q', 'Initials': 'SQ', 'LastName': 'Fu', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202003_20653']
232,32189446,Simulation in Urological Training and Education (SIMULATE): Protocol and curriculum development of the first multicentre international randomized controlled trial assessing the transferability of simulation-based surgical training.,"OBJECTIVES


To report the study protocol for the first international multicentre randomized controlled trial investigating the effectiveness of simulation-based surgical training and the development process for an evidence-based training curriculum, to be delivered as an educational intervention.
PARTICIPANTS AND METHODS


This prospective, international, multicentre randomized controlled clinical and educational trial will recruit urology surgical trainees who must not have performed ≥10 of the selected index procedure, ureterorenoscopy (URS). Participants will be randomized to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally. The primary outcome is the number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skills (OSATS) assessment scale, for three consecutive operations, without any complications. All participants will be followed up either until they complete 25 procedures or for 18 months. Development of the URS SBT curriculum took place through a two-round Delphi process.
RESULTS


A total of 47 respondents, consisting of trainees (n = 24) with URS experience and urolithiasis specialists (n = 23), participated in round 1 of the Delphi process. Specialists (n = 10) finalized the content of the curriculum in round 2. The developed interventional curriculum consists of initial theoretic knowledge through didactic lectures followed by select tasks and cases on the URO-Mentor (Simbionix, Lod, Israel) VR Simulator, Uro-Scopic Trainer (Limbs & Things, Bristol, UK) and Scope Trainer (Mediskills, Manchester, UK) models for both semi-rigid and flexible URS. Respondents also selected relevant non-technical skills scenarios and cadaveric simulation tasks as additional components, with delivery subject to local availability.
CONCLUSIONS


SIMULATE is the first multicentre trial investigating the effect and transferability of supplementary SBT on operating performance and patient outcomes. An evidence-based training curriculum is presented, developed with expert and trainee input. Participants will be followed and the primary outcome, number of procedures required to proficiency, will be reported alongside key clinical secondary outcomes, (ISCRTN 12260261).",2020,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","['47 respondents consisting of trainees (n=24), with URS experience, and urolithiasis specialists (n=23) participated in round-1 of the Delphi process', 'Surgery', 'urology surgical trainees who must not have performed ≥ 10 of the selected index procedure, ureterorenoscopy (URS']","['Transferability of Simulation-based Training', 'simulation-based surgical training', 'simulation-based training (SBT) or non-simulation-based training (NSBT']","['number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skill (OSATS) assessment scale, on 3 consecutive operations, without any complications']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1270970', 'cui_str': 'Ureterorenoscopy (procedure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.182342,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","[{'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Aydin', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""School of Cancer and Pharmaceutical Studies, King's College London, London, UK.""}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, UK.'}, {'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJU international,['10.1111/bju.15056']
233,32178766,"Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial.","BACKGROUND


The interleukin-23 (IL-23)/T-helper 17 cell pathway is implicated in psoriatic arthritis pathogenesis. Guselkumab, an IL-23 inhibitor that specifically binds the IL-23 p19 subunit, significantly and safely improved psoriatic arthritis in a phase 2 study. DISCOVER-2 was a phase 3 trial to assess guselkumab in biologic-naive patients with psoriatic arthritis.
METHODS


This phase 3, double-blind, placebo-controlled study was done at 118 sites in 13 countries across Asia, Europe, and North America. We enrolled biologic-naive patients with active psoriatic arthritis (at least five swollen joints, at least five tender joints, and C-reactive protein ≥0·6 mg/dL) despite standard therapies. Patients were randomly assigned (1:1:1, computer-generated permuted blocks; stratified by baseline disease-modifying antirheumatic drug use and C-reactive protein concentration) to subcutaneous injections of guselkumab 100 mg every 4 weeks; guselkumab 100 mg at weeks 0, 4, then every 8 weeks; or placebo. The primary endpoint was American College of Rheumatology 20% improvement (ACR20) response at week 24 in all patients per assigned treatment group. Safety was assessed in all patients per treatment received. This trial is registered at ClinicalTrials.gov, NCT03158285 (active, not recruiting).
FINDINGS


From July 13, 2017, to Aug 3, 2018, 1153 patients were screened, of whom 741 were randomly assigned to receive guselkumab every 4 weeks (n=246), every 8 weeks (n=248), or placebo (n=247). One patient in the every 4 weeks group and one in the placebo group did not start treatment, and the remaining 739 patients started treatment; 716 patients continued treatment up to week 24. Significantly greater proportions of patients in the guselkumab every 4 weeks group (156 [64%] of 245 [95% CI 57-70]) and every 8 weeks group (159 [64%] of 248 [58-70]) than in the placebo group (81 [33%] of 246 [27-39]) achieved an ACR20 response at week 24 (percentage differences vs placebo 31% [95% CI 22-39] for the every 4 weeks group and 31% [23-40] for the every 8 weeks group; both p<0·0001). Up to week 24, serious adverse events occurred in eight (3%) of 245 patients receiving guselkumab every 4 weeks (three serious infections), three (1%) of 248 receiving guselkumab every 8 weeks (one serious infection), and seven (3%) of 246 receiving placebo (one serious infection). No deaths occurred.
INTERPRETATION


Guselkumab, a human monoclonal antibody that specifically inhibits IL-23 by binding the cytokine's p19 subunit, was efficacious and demonstrated an acceptable benefit-risk profile in patients with active psoriatic arthritis who were naive to treatment with biologics. These data support the use of selective inhibition of IL-23 to treat psoriatic arthritis.
FUNDING


Janssen Research and Development.",2020,"Up to week 24, serious adverse events occurred in eight (3%) of 245 patients receiving guselkumab every 4 weeks (three serious infections), three (1%) of 248 receiving guselkumab every 8 weeks (one serious infection), and seven (3%) of 246 receiving placebo (one serious infection).","['118 sites in 13 countries across Asia, Europe, and North America', 'biologic-naive patients with psoriatic arthritis', 'biologic-naive patients with active psoriatic arthritis (DISCOVER-2', 'From July 13, 2017, to Aug 3, 2018, 1153 patients were screened, of whom 741', 'patients with active psoriatic arthritis who were naive to treatment with biologics', 'enrolled biologic-naive patients with active psoriatic arthritis (at least five swollen joints, at least five tender joints, and C-reactive protein ≥0·6 mg/dL) despite standard therapies']","['guselkumab 100 mg every 4 weeks; guselkumab', 'Guselkumab', 'guselkumab', 'placebo']","['psoriatic arthritis', 'ACR20 response', 'serious adverse events', 'American College of Rheumatology 20% improvement (ACR20) response', 'Safety']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1153.0,0.608705,"Up to week 24, serious adverse events occurred in eight (3%) of 245 patients receiving guselkumab every 4 weeks (three serious infections), three (1%) of 248 receiving guselkumab every 8 weeks (one serious infection), and seven (3%) of 246 receiving placebo (one serious infection).","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Department of Rheumatology, Swedish Medical Center, Providence St Joseph Health and University of Washington, Seattle, WA, USA. Electronic address: pmease@philipmease.com.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Department of Rheumatology, Memorial University of Newfoundland, St Johns, NL, Canada.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Alexa P', 'Initials': 'AP', 'LastName': 'Kollmeier', 'Affiliation': 'Immunology, Janssen Research and Development, San Diego, CA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Immunology, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Immunology, Janssen Research and Development, San Diego, CA, USA.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Prasheen', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, Janssen Research and Development, Spring House, PA, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'Division of Immunology, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30263-4']
234,31700147,The effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury: an exploratory study.,"STUDY DESIGN


Experimental before-after design.
OBJECTIVES


The objectives of this study were to explore the effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury (SCI).
SETTING


Research laboratory.
METHODS


Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls. Each participant underwent seven protocols, including pressure (60 mmHg) with local cooling (∆t = -10 °C) for 20 min at three cooling rates (-0.5, -4, -10 °C/min), pressure with local cooling for 40 min, pressure with local heating (∆t = +10 °C), local cooling without pressure, and pressure without temperature changes. Each protocol included a 10-min baseline, a 20-min (or 40-min) loading period and a 20-min recovery. A compound sensor head consisting of laser Doppler and heating and cooling probes was used to measure sacral skin blood flow and temperature in the prone position. Blood flow responses were characterized by peak blood flow, recovery time, and total blood flow in the recovery period.
RESULTS


The results demonstrated that the cooling rate at -10 °C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min. There was a significant difference in the recovery time between the 20-min cooling compared with the 40-min cooling for the SCI group (p < 0.05).
CONCLUSIONS


Our findings provide initial evidence that local cooling rates affect skin blood flow responses under externally applied pressure in people with SCI.",2020,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"['people with spinal cord injury', 'people with spinal cord injury (SCI', 'people with SCI', 'Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls']","['laser Doppler and heating and cooling probes', 'local cooling rates']","['peak blood flow, recovery time, and total blood flow', 'cooling rate at -10', 'smaller skin blood flow response', 'cooling rate', 'sacral skin blood flow and temperature', 'recovery time', 'Blood flow responses']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",17.0,0.0858534,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"[{'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA. yjan@illinois.edu.'}]",Spinal cord,['10.1038/s41393-019-0378-x']
235,31710340,"Reactions to Multiple Ascending Doses of the Microtubule Stabilizer TPI-287 in Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome: A Randomized Clinical Trial.","Importance


Basket-design clinical trials that allow investigation of treatment effects on different clinical syndromes that share the same molecular pathophysiology have not previously been attempted in neurodegenerative disease.
Objective


To assess the safety, tolerability, and pharmacodynamics of the microtubule stabilizer TPI-287 (abeotaxane) in Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).
Design, Setting, and Participants


Two parallel-design, double-blind, placebo-controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham. A total of 94 patients with clinically diagnosed AD (n = 39) and 4RT (n = 55) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria. A total of 29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled. Data were analyzed from December 20, 2013, through May 4, 2017, based on modified intention to treat.
Interventions


Randomization was 8:3 drug to placebo in 3 sequential dose cohorts receiving 2.0, 6.3, or 20.0 mg/m2 of intravenous TPI-287 once every 3 weeks for 9 weeks, with an optional 6-week open-label extension.
Main Outcomes and Measures


Primary end points were safety and tolerability (maximal tolerated dose) of TPI-287. Secondary and exploratory end points included TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures.
Results


A total of 68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT (16 women [38%]; median age, 69 [range, 54-83] years). Three severe anaphylactoid reactions occurred in TPI-287-treated patients with AD, whereas none were seen in patients with 4RT, leading to a maximal tolerated dose of 6.3 mg/m2 for AD and 20.0 mg/m2 for 4RT. More falls (3 in the placebo group vs 11 in the TPI-287 group) and a dose-related worsening of dementia symptoms (mean [SD] in the CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures], 0.5 [1.8] in the placebo group vs 0.7 [1.6] in the TPI-287 group; median difference, 1.5 [95% CI, 0-2.5]; P = .03) were seen in patients with 4RT. Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 [26.0] ng/mL) compared with placebo (mean [SD], 10.4 [42.3] ng/mL; median difference, -14.6 [95% CI, -30.0 to 0.2] ng/mL; P = .048, Mann-Whitney test).
Conclusions and Relevance


In this randomized clinical trial, TPI-287 was less tolerated in patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions. The ability to reveal different tau therapeutic effects in various tauopathy syndromes suggests that basket trials are a valuable approach to tau therapeutic early clinical development.
Trial Registration


ClinicalTrials.gov identifiers: NCT019666666 and NCT02133846.",2020,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","['29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled', '94 patients with clinically diagnosed AD (n\u2009=\u200939) and 4RT (n\u2009=\u200955) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria', '16 women [38%]; median age, 69 [range, 54-83] years', 'patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions', 'Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome', 'Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS', 'controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham', '68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT']","['microtubule stabilizer TPI-287 (abeotaxane', 'placebo', 'Microtubule Stabilizer TPI-287', 'TPI-287']","['safety and tolerability (maximal tolerated dose) of TPI-287', 'CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures', 'severe anaphylactoid reactions', 'TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures', 'worsening of dementia symptoms', 'safety, tolerability, and pharmacodynamics', 'chitinase-3-like protein-1 (YKL-40) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0949664', 'cui_str': 'Tauopathies'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0026046', 'cui_str': 'Microtubules'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0751072', 'cui_str': 'FTLD'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal Lobe Dementia (FLDEM)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027903', 'cui_str': 'Neuropsychologies'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3872855', 'cui_str': 'GP-39 Protein'}]",68.0,0.508308,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Tsai', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Koestler', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Rojas', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ljubenkov', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Rosen', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Gil D', 'Initials': 'GD', 'LastName': 'Rabinovici', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Cobigo', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Joo In', 'Initials': 'JI', 'LastName': 'Jung', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hare', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Natelson-Love', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'McKinley', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Luong', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emmeline L', 'Initials': 'EL', 'LastName': 'Chuu', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Powers', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Mumford', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Merhdad', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Wu Tsai Neurosciences Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Roberson', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3812']
236,28795605,Reducing sugar use in coffee while maintaining enjoyment: A randomized controlled trial.,"Consuming coffee without (or with less) sugar may help people lower their daily calorie intake without restrictive dieting. We tested two theory-based interventions to help people do so. One involved gradually reducing sugar over time, and the other was based on mindfulness theory. These interventions were compared to a repeated exposure (to sugar-free coffee) group. Participants in all conditions had significant increases in consumption of sugar-free coffee that lasted 6 months. The mindfulness group had a larger increase than the others. Unexpectedly, the gradual reduction intervention led to a decrease in liking for sugar-free coffee and was the least effective.",2020,"Unexpectedly, the gradual reduction intervention led to a decrease in liking for sugar-free coffee and was the least effective.",[],['Consuming coffee without (or with less) sugar'],"['liking for sugar-free coffee', 'consumption of sugar-free coffee']",[],"[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0245401,"Unexpectedly, the gradual reduction intervention led to a decrease in liking for sugar-free coffee and was the least effective.","[{'ForeName': 'Richie L', 'Initials': 'RL', 'LastName': 'Lenne', 'Affiliation': 'University of Minnesota, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Mann', 'Affiliation': 'University of Minnesota, USA.'}]",Journal of health psychology,['10.1177/1359105317723452']
237,28882072,Women's experiences of exercise as a treatment for their postnatal depression: A nested qualitative study.,Women with postnatal depression are often reluctant to take medication postnatally and access to psychological therapies is limited. Exercise offers a freely available treatment option but depressed mothers' experience of exercise has not been investigated. We conducted a qualitative study nested within a randomised trial of an exercise intervention for women with postnatal depression. Women described deterioration in their sense of identity postnatally and through experiencing depression and described the positive impact exercise had on their sense of self. Views of exercise as treatment for postnatal depression ranged from doubts about its practicality to positive comparisons with other traditional treatments and to improved recovery.,2020,Views of exercise as treatment for postnatal depression ranged from doubts about its practicality to positive comparisons with other traditional treatments and to improved recovery.,"['women with postnatal depression', 'Women with postnatal depression']",['exercise intervention'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0547968,Views of exercise as treatment for postnatal depression ranged from doubts about its practicality to positive comparisons with other traditional treatments and to improved recovery.,"[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pritchett', 'Affiliation': 'University of Birmingham, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'University of Birmingham, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Daley', 'Affiliation': 'University of Birmingham, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Turner', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bradbury-Jones', 'Affiliation': 'University of Birmingham, UK.'}]",Journal of health psychology,['10.1177/1359105317726590']
238,31228560,Mechanisms of Change in the Prevention of Depression: An Indicated School-Based Prevention Trial at the Transition to High School.,"OBJECTIVE


Depression represents a major public health concern, and prevalence increases significantly during adolescence. The high school transition may exacerbate the risk of depression for youth with pre-existing vulnerability. The High School Transition Program (HSTP) is a brief, skills-based intervention that has demonstrated efficacy in preventing depression in adolescents. The current study aimed to evaluate the theorized mechanisms of change of the HSTP intervention by testing a multiple mediation model including school attachment (SA) and self-esteem (SE) as two mediators of treatment outcomes.
METHOD


Students (N= 497; 61.5% girls) with elevated depressive symptoms, identified for the intervention program via an eighth-grade screening, were randomized to a brief intervention (n = 247) or the HSTP (n = 233) from 2003 to 2008. Participants completed measures at five time points. The first assessment occurred at the start of the second semester of eighth grade and the last assessment occurred at the end of ninth grade. A multiple mediation model tested whether SA and SE contributed to changes in depression for youth in the HSTP.
RESULTS


The mediation model, including contemporaneously assessed SE and SA, was not supported. There was evidence of sequential mediation, such that students who participated in the HSTP intervention reported higher SA, which in turn predicted improved SE, and in turn contributed to amelioration of depressive symptoms.
CONCLUSION


The HSTP intervention ameliorated depressive symptoms by targeting factors specific to the school transition (ie, SA). Results suggest youth at risk for depression may benefit from prevention efforts that enhance students' capacity to effectively manage identified environmental stressors, such as school transitions.
CLINICAL TRIAL REGISTRATION INFORMATION


Middle School to High School Transition Project: Depression and Substance Abuse Prevention; https://clinicaltrials.gov/; NCT00071513.",2020,The High School Transition Program (HSTP) is a brief skills-based intervention that has demonstrated efficacy in preventing depression in adolescents.,"['Depression', 'adolescents', 'Students (N= 497; 61.5% girls) with elevated depressive symptoms, identified for the intervention program via an 8 th  grade screening']","['HSTP intervention', 'HSTP', 'SA and SE', 'High School Transition Program (HSTP']","['depressive symptoms', 'school attachment (SA) and self-esteem (SE']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",,0.0275987,The High School Transition Program (HSTP) is a brief skills-based intervention that has demonstrated efficacy in preventing depression in adolescents.,"[{'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Blossom', 'Affiliation': ""University of Washington School of Medicine, Seattle; Seattle Children's Hospital, WA. Electronic address: jblossom@uw.edu.""}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Adrian', 'Affiliation': ""University of Washington School of Medicine, Seattle; Seattle Children's Hospital, WA.""}, {'ForeName': 'Ann Vander', 'Initials': 'AV', 'LastName': 'Stoep', 'Affiliation': 'University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McCauley', 'Affiliation': ""University of Washington School of Medicine, Seattle; Seattle Children's Hospital, WA.""}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.05.031']
239,29347825,Increasing condom usage for African-American and hispanic young fathers in a community based intervention.,"Objectives:  This paper investigates a community-based intervention for young fathers,  FatherWorks , compared to care-as-usual,  24/7 Dads . We hypothesized that utilizing the  FatherWorks  intervention (a 15 session parenting intervention, 13 session employment class, paid internship, case management, and access to behavioral health services) will assist in readiness to use condoms and increase condom usage, which may differ by race/ethnicity. Methods:  Eligible males ( n  = 328) were enrolled into a Randomized Control Trial. Participants were 15-24 years old and had fathered one or more children with a female under the age of 21. A survey was taken at baseline and at 15 weeks following the intervention. Results:  Analyses of changes indicated that intervention participants improved from the pre-contemplation stage of condom usage towards contemplation, and from preparation to action. The pattern of improvement in the condom use stage of change was different in African-American versus Hispanic participants. Changes in condom use during last intercourse were not significant. Conclusions : Study findings indicate that  FatherWorks  is successful in increasing the intent to use condoms, with the effect manifesting differently in African-American and Hispanic young fathers. Future work with minority fathers indicates a need for cultural adaptation of the intervention.",2020,"Changes in condom use during last intercourse were not significant.
","['young fathers, FatherWorks, compared to care-as-usual, 24/7 Dads', 'African-American and hispanic young fathers', 'Participants were 15-24 years old and had fathered one or more children with a female under the age of 21', 'Eligible males (n\u2009=\u2009328', 'African-American and Hispanic young fathers']",['FatherWorks intervention'],['pre-contemplation stage of condom usage towards contemplation'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0015671', 'cui_str': 'Fathers'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1277196', 'cui_str': 'Contemplation stage'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",328.0,0.0170826,"Changes in condom use during last intercourse were not significant.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mogro-Wilson', 'Affiliation': 'School of Social Work, University of Connecticut, Hartford, CT, USA.'}, {'ForeName': 'Aubri', 'Initials': 'A', 'LastName': 'Drake', 'Affiliation': 'Health Disparities Institute, University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Emil', 'Initials': 'E', 'LastName': 'Coman', 'Affiliation': 'Health Disparities Institute, University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Toral', 'Initials': 'T', 'LastName': 'Sanghavi', 'Affiliation': 'Process Management and Analytics, The Village for Families and Children, Hartford, CT, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Martin-Peele', 'Affiliation': 'Health Disparities Institute, University of Connecticut Health Center, Farmington, CT, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Fifield', 'Affiliation': 'Health Disparities Institute, University of Connecticut Health Center, Farmington, CT, USA.'}]",Ethnicity & health,['10.1080/13557858.2018.1427704']
240,31767947,Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.,"STUDY DESIGN


Clinical trial.
OBJECTIVE


Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo).
SETTING


Community.
METHOD


Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability.
RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 10 5  ± 0.9 × 10 5  mmHg • beat) than placebo (4.4 × 10 5  ± 0.6 × 10 5  mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use.
CONCLUSIONS


At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.",2020,"RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","['Participants (n\u2009=\u200913; age 44.0\u2009±\u20093.3\xa0years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring', 'during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia', 'Community']","['lidocaine', 'standard lubricant (placebo', 'placebo', 'lidocaine lubricant', 'lidocaine lubricant (Xylocaine 2%) ameliorates AD', 'Lidocaine lubricant']","['autonomic function', 'Overall, SAP', 'maximum SAP', 'Heart rate and rhythm disturbances', 'Bowel care duration', 'low-frequency systolic arterial pressure (LF SAP) variability']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0161959', 'cui_str': 'Cardiovascular monitoring (regime/therapy)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0238015', 'cui_str': 'Spinal Autonomic Dysreflexia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.186011,"RESULTS


Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","[{'ForeName': 'Vera-Ellen M', 'Initials': 'VM', 'LastName': 'Lucci', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'McGrath', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Inskip', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Shirromi', 'Initials': 'S', 'LastName': 'Sarveswaran', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Willms', 'Affiliation': 'International Collaboration on Repair and Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Claydon', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada. victoria_claydon@sfu.ca.'}]",Spinal cord,['10.1038/s41393-019-0381-2']
241,32267646,[Experiences with axillary reverse mapping].,"Axillary reverse mapping (ARM) is a technique by which the lymphatic drainage system of the upper extremities is mapped, so that the lymph channels and glands can be preserved during axillary lymph node dissection (ALND). This can lead to less postoperative morbidity, such as lymphoedema. A randomised multicentre study showed that there are statistically significantly fewer post-operative symptoms if the lymph channels and glands of the upper extremities are spared with this technique. Despite the declining indication for an ALND, ARM can have added value for the patients who do have to undergo ALND.",2020,"Despite the declining indication for an ALND, ARM can have added value for the patients who do have to undergo ALND.",['patients who do have to undergo ALND'],['Axillary reverse mapping (ARM'],['postoperative morbidity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0629915,"Despite the declining indication for an ALND, ARM can have added value for the patients who do have to undergo ALND.","[{'ForeName': 'Martinus A', 'Initials': 'MA', 'LastName': 'Beek', 'Affiliation': 'AmphiaZiekenhuis, afd. Chirurgie, Breda.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Gobardhan', 'Affiliation': 'Amphia Ziekenhuis, afd. Chirurgie, Breda.'}, {'ForeName': 'Elisabeth G', 'Initials': 'EG', 'LastName': 'Klompenhouwer', 'Affiliation': 'Nederlands Kanker Instituut, afd. Radiologie, Amsterdam.'}, {'ForeName': 'Harm J T', 'Initials': 'HJT', 'LastName': 'Rutten', 'Affiliation': 'Catharina Ziekenhuis, afd. Chirurgie, Eindhoven.'}, {'ForeName': 'Adri C', 'Initials': 'AC', 'LastName': 'Voogd', 'Affiliation': 'Maastricht UMC+, afd. Epidemiologie, Maastricht.'}, {'ForeName': 'Ernest J T', 'Initials': 'EJT', 'LastName': 'Luiten', 'Affiliation': 'Amphia Ziekenhuis, afd. Chirurgie, Breda.'}]",Nederlands tijdschrift voor geneeskunde,[]
242,31872563,Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities.,"OBJECTIVE


This study examined clinical and retention outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities (i.e., home-based telehealth [HBT], office-based telehealth [OBT], or in-home-in-person [IHIP]).
METHOD


A randomized clinical trial design was used to compare variable-length PE delivered through HBT, OBT, or IHIP. Treatment duration (i.e., number of sessions) was determined by either achievement of a criterion score on the PTSD Checklist for Diagnostic and Statistical Manual-5 (DSM-5; PTSD Checklist for DSM-5) for two consecutive sessions or completion of 15 sessions. Participants received PE via HBT (n = 58), OBT (n = 59) or IHIP (n = 58). Data were collected between 2012 and 2018, and PTSD was diagnosed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), administered at baseline, posttreatment, and 6 months following treatment completion. The primary clinical outcome was CAPS-5 PTSD severity. Secondary outcomes included self-reported PTSD and depression symptoms, as well as treatment dropout.
RESULTS


The clinical effectiveness of PE did not differ by treatment modality across any time point; however, there was a significant difference in treatment dropout. Veterans in the HBT (odds ratio [OR] = 2.67; 95% confidence interval [CI] = 1.10, 6.52; p = .031) and OBT (OR = 5.08; 95% CI = 2.10; 12.26; p < .001) conditions were significantly more likely than veterans in IHIP to drop out of treatment.
CONCLUSIONS


Providers can effectively deliver PE through telehealth and in-home, in-person modalities although the rate of treatment completion was higher in IHIP care.",2020,"Veterans in the HBT (odds ratio [OR] = 2.67; 95% confidence interval [CI] = 1.10, 6.52; p = .031) and OBT (OR = 5.08; 95% CI = 2.10; 12.26; p < .001) conditions were significantly more likely than veterans in IHIP to drop out of treatment.
",['posttraumatic stress disorder (PTSD'],"['Home-based delivery of variable length prolonged exposure therapy', 'variable length prolonged exposure (PE', 'HBT, OBT, or IHIP', 'OBT', 'PE via HBT', 'home-based telehealth [HBT], office-based telehealth [OBT']","['self-reported PTSD and depression symptoms, as well as treatment dropout', 'PTSD Checklist for Diagnostic and Statistical Manual-5', 'OBT', 'CAPS-5 PTSD severity']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0315262,"Veterans in the HBT (odds ratio [OR] = 2.67; 95% confidence interval [CI] = 1.10, 6.52; p = .031) and OBT (OR = 5.08; 95% CI = 2.10; 12.26; p < .001) conditions were significantly more likely than veterans in IHIP to drop out of treatment.
","[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Morland', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Margaret-Anne', 'Initials': 'MA', 'LastName': 'Mackintosh', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Glassman', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Stephanie Y', 'Initials': 'SY', 'LastName': 'Wells', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Thorp', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Phillippe B', 'Initials': 'PB', 'LastName': 'Cunningham', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Grubbs', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Golshan', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Min Ji', 'Initials': 'MJ', 'LastName': 'Sohn', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Regional TeleMental Health Program, VA San Diego Healthcare System, San Diego, California.'}]",Depression and anxiety,['10.1002/da.22979']
243,32264985,iMAgery focused psychological therapy for persecutory delusions in PSychosis (iMAPS): a multiple baseline experimental case series.,"BACKGROUND


Many people with psychosis experience persecutory delusions and report negative schematic beliefs and intrusive mental images which may be maintaining factors for psychotic symptoms.
AIMS


This study examined the feasibility and acceptability of a new psychological therapy targeting schemas and images (iMAPS therapy).
METHOD


The study used a randomised multiple baseline design. Participants with first episode psychosis were randomised using a multiple baseline design with 2-5 assessments. Six sessions of therapy, consisting of a combination of imagery techniques and imagery rescripting techniques, was used. In each session, participants completed a Mental Imagery in Psychosis Questionnaire (MIPQ) and imagery interview. Mood and delusional beliefs (PSYRATS) were also measured at each session.
RESULTS


Five participants with first episode psychosis completed the baseline visits and attended all therapy sessions. One participant declined the final assessment. Results demonstrated significant reductions in negative schematic beliefs, delusions, imagery distress and other measures of schema (YSQ, SMI). Although multiple baseline randomisation strengthens the study, it lacked a control arm and blind assessments.
CONCLUSIONS


iMAPS appears a feasible and acceptable treatment for psychosis, and further evaluation is indicated.",2020,"Results demonstrated significant reductions in negative schematic beliefs, delusions, imagery distress and other measures of schema (YSQ, SMI).","['Participants with first episode psychosis', 'persecutory delusions in PSychosis (iMAPS']","['new psychological therapy targeting schemas and images (iMAPS therapy', 'iMAPS', 'iMAgery focused psychological therapy']","['feasibility and acceptability', 'negative schematic beliefs, delusions, imagery distress and other measures of schema (YSQ, SMI', 'Mental Imagery in Psychosis Questionnaire (MIPQ) and imagery interview', 'Mood and delusional beliefs (PSYRATS']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0349398', 'cui_str': 'Paranoid delusion'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0592034', 'cui_str': 'Redeptin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",5.0,0.0294871,"Results demonstrated significant reductions in negative schematic beliefs, delusions, imagery distress and other measures of schema (YSQ, SMI).","[{'ForeName': 'Christopher D J', 'Initials': 'CDJ', 'LastName': 'Taylor', 'Affiliation': 'Secondary Care Psychological Therapies Service, Pennine Care NHS Foundation Trust, Humphrey House, Angouleme Way, BuryML9 0EQ, UK.'}, {'ForeName': 'Penny E', 'Initials': 'PE', 'LastName': 'Bee', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Greater Manchester Mental Health NHS Foundation Trust, Trust Headquarters, Bury New Road, Prestwich, ManchesterM25 3BL, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, Denmark Hill, LondonSE5 8AF, UK.""}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Haddock', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Zochonis Building, Brunswick Street, ManchesterM13 9PL, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000168']
244,32252049,The Effect of Lactofem Oral Probiotic Capsule on Lactobacilli Colonization and Some Vaginal Health Parameters.,"BACKGROUND AND OBJECTIVE


Healthy vaginal ecosystem is conserved with the connection of vaginal epithelium and flora in which lactobacilli play a significant role. The present study aimed to examine the effect of lactofem oral probiotic capsule on Lactobacillus colonization and some other vaginal health indices in women aged 18-55 years.
MATERIALS AND METHODS


This interventional, double-blind controlled clinical trial was conducted on 70 women with Nugent score = 4-6 and vaginal pH >4.5. The participants were divided into an oral probiotic group and a control group. The oral probiotic group was required to take one 500 mg lactofem capsule daily for 2 months, while placebo was prescribed for the control group. Samples from 6 visits were examined during the period of prescription. The data were analyzed using the SPSS statistical software, version 18.
RESULTS


The results showed no significant difference in the average colonization of vaginal Lactobacillus in the 2 groups before and during the intervention (p = 0.26). Also, no significant difference was observed in the 2 groups' Nugent mean scores before and after the intervention up to the 60th day. However, a statistically significant difference was found in this regard on the 70th day (p = 0.032). Moreover, the results indicated no significant difference in the 2 groups' mean vaginal pH before and after the intervention (p = 0.101).
CONCLUSION


Lactofem oral capsule could improve the participants' Nugent scores, but caused no change in Lactobacillus colonization or vaginal pH.",2020,"However, a statistically significant difference was found in this regard on the 70th day (p = 0.032).","['70 women with Nugent score\xa0= 4-6 and vaginal pH >4.5', 'women aged 18-55 years']","['lactofem oral probiotic capsule', 'Lactofem Oral Probiotic Capsule', 'placebo']","['vaginal health indices', 'average colonization of vaginal Lactobacillus', 'mean vaginal pH', 'Lactobacilli Colonization and Some Vaginal Health Parameters', 'Lactobacillus colonization or vaginal pH']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0317616,"However, a statistically significant difference was found in this regard on the 70th day (p = 0.032).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Balaghi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran, azimas@sums.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Motamedifar', 'Affiliation': 'Department of Bacteriology and Virology, School of Medicine, and HIV/AIDS Research Center (SHARC), Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maasumeh', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Poordast', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Najaf', 'Initials': 'N', 'LastName': 'Zare', 'Affiliation': 'Department of Biostatistics, Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Gynecologic and obstetric investigation,['10.1159/000506802']
245,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
246,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
247,32249609,High cardiovascular reactivity and muscle strength attenuate hypotensive effects of isometric handgrip training in young women: A randomized controlled trial.,"OBJECTIVE


Isometric resistance training may reduce resting blood pressure (BP); however, the magnitude of this effect varies among individual subjects and few studies attempted to predict it. This study aimed to investigate the potential hypotensive effects of isometric training and their association with cardiovascular reactivity to acute isometric exercise and muscle strength in young women.
METHODS


In this randomized trial, twenty young women were randomly assigned to either the training (n = 10) or control (n = 10) group. Women from the training group performed unilateral isometric handgrip sessions for 8 weeks (4 × 2 min at 25% of maximal voluntary contraction [MVC]; 3 days/week). Cardiovascular reactivity to acute isometric exercise and MVC were measured at baseline. Resting BP was assessed during and after the intervention.
RESULTS


Resting systolic BP significantly lowered only in the training group. The change in resting systolic BP following an 8-week intervention was significantly associated with the systolic BP and diastolic BP reactivity to the acute exercise at baseline during set 3 and 4 ( P  <.05). The handgrip MVC was associated with changes in systolic BP (r = 0.79,  P  =.007), diastolic BP (r = 0.68,  P  =.032), and mean arterial pressure (r = 0.79,  P  =.006). These results indicated that high cardiovascular reactivity and strength attenuate the hypotensive effects following isometric training in young women.
CONCLUSIONS


The hypotensive effects following isometric training may be identified by BP reactivity to acute isometric exercise or handgrip strength in young women.",2020,The change in resting systolic BP following an 8-week intervention was significantly associated with the systolic BP and diastolic BP reactivity to the acute exercise at baseline during set 3 and 4 ( P  <.05).,"['young women', 'twenty young women']","['unilateral isometric handgrip sessions', 'isometric training', 'acute isometric exercise', 'Isometric resistance training', 'isometric handgrip training']","['resting systolic BP', 'hypotensive effects', 'diastolic BP', 'Resting BP', 'systolic BP', 'mean arterial pressure', 'resting blood pressure (BP', 'Resting systolic BP', 'systolic BP and diastolic BP reactivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",20.0,0.0406729,The change in resting systolic BP following an 8-week intervention was significantly associated with the systolic BP and diastolic BP reactivity to the acute exercise at baseline during set 3 and 4 ( P  <.05).,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamagata', 'Affiliation': ""Department of Clothing, Faculty of Human Sciences and Design, Japan Women's University , Tokyo, Japan.""}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Sako', 'Affiliation': ""Department of Food and Nutrition, Faculty of Human Sciences and Design, Japan Women's University , Tokyo, Japan.""}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1747482']
248,32159257,"A randomized, double-blind, placebo-controlled clinical trial, evaluating the garlic supplement effects on some serum biomarkers of oxidative stress, and quality of life in women with rheumatoid arthritis.","AIM


Rheumatoid arthritis (RA), is a prevalent immune-inflammatory disease, which is associated with disabling pain. Oxidative stress might play a role in RA pathogenesis and outcomes. According to the antioxidant properties of garlic, the current study was performed to evaluate the garlic supplement effects on some serum levels of oxidative stress biomarkers, and quality of life in patients with rheumatoid arthritis.
METHODS


Seventy women with RA participated in this randomized, double-blind, placebo-controlled, parallel-design trial. The patients were randomly divided into two groups, receiving two tablets of either 500 mg garlic or placebo daily for 8 weeks. Serum levels of total antioxidant capacity (TAC) and malondialdehyde (MDA) and quality of life were determined at baseline and end of week 8. A health assessment questionnaire (HAQ) was used to evaluate the quality of life related to health.
RESULTS


Of 70 patients enrolled in the trial, 62 subjects were included in the final analysis. At the end of the study, there was a significant increase in serum levels of TAC in the garlic group as compared with the placebo group (26.58 ± 77.30 nmol of Trolox equivalent/ml vs 16.11 ± 0.92 nmol of Trolox equivalent/mL; P = .026). In addition, MDA levels were significantly decreased in the intervention group compared with the control group (-0.82 ± 1.99 nmol/mL vs 0.36 ± 2.57 nmol/mL; P = .032). Pain after activity and HAQ scores decreased in the garlic group compared with the placebo (-11.96 ± 13.43 mm vs -0.06 ± 13.41 mm; P < .001, 0.17 ± 20 vs 0.05 ± 0.15; P < .001, respectively).
CONCLUSIONS


The findings suggest that garlic supplementation for 8 weeks resulted in significant improvements in oxidative stress, HAQ in women with RA.",2020,"Pain after activity and HAQ scores decreased in the garlic group compared to the placebo (-11.96±13.43 mm vs. -0.06±13.41 mm; P<0.001, 0.17±20 vs. 0.05±0.15; P<0.001, respectively).
","['62 subjects were included in the final analysis', '70 patients enrolled in the trial', 'women with rheumatoid arthritis', 'Seventy women with RA', 'women with RA', 'patients with rheumatoid arthritis']","['garlic supplementation', '500 mg garlic or placebo', 'placebo']","['quality of life related to health', 'oxidative stress biomarkers, and quality of life', 'Pain after activity and HAQ scores', 'MDA levels', 'oxidative stress, HAQ', 'serum biomarkers of oxidative stress, and quality of life', 'Serum levels of total antioxidant capacity (TAC) and malondialdehyde (MDA) and quality of life', 'serum levels of TAC']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]",62.0,0.588452,"Pain after activity and HAQ scores decreased in the garlic group compared to the placebo (-11.96±13.43 mm vs. -0.06±13.41 mm; P<0.001, 0.17±20 vs. 0.05±0.15; P<0.001, respectively).
","[{'ForeName': 'Seyedeh Parisa', 'Initials': 'SP', 'LastName': 'Moosavian', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Habibagahi', 'Affiliation': 'Department of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",International journal of clinical practice,['10.1111/ijcp.13498']
249,31702385,Effect of a nurse-led individualized self-management program for Chinese patients with acute myocardial infarction undergoing percutaneous coronary intervention.,"BACKGROUND


The study of the development and evaluation of self-management intervention among patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is lacking, especially in China.
AIM


To examine the effects of a nurse-led individualized self-management program (NISMP) on health behaviors, control of cardiac risk factors, and health-related quality of life (HRQoL) among patients with AMI undergoing PCI.
METHODS


The quasi-experimental design included a convenience sample of 112 participants recruited from a tertiary hospital in China. The participants were assigned to the control group ( n  = 56) or the intervention group ( n  = 56). The intervention group underwent the NISMP, which includes six group-based education sessions, a face-to-face individual consultation, and 12-month telephone follow-ups. Data were collected at baseline and at the end of the 12-month program using the Health Promotion Lifestyle Profile, the Risk Factors Assessment Form, and the Short Form 36-item Health Survey.
RESULTS


The baseline sociodemographic and clinical characteristics of the two groups were comparable ( p  > 0.05). After the 12-month intervention, the health behaviors and HRQoL of the participants in the intervention group had significantly improved ( p  < 0.05 for both) compared to those of the control group. Compared to the control group, the participants in the intervention group also reported significantly better control of cardiac risk factors including smoking (χ 2  = 4.709,  p  = 0.030), low-density lipoprotein (χ 2  = 4.160,  p  = 0.041), body mass index (χ 2  = 3.886,  p  = 0.049) and exercise (χ 2  = 10.096,  p  = 0.001).
CONCLUSION


The NISMP demonstrated positive effects on health behaviors, control of cardiac risk factors, and HRQoL among Chinese patients with AMI undergoing PCI.",2020,"Compared to the control group, the participants in the intervention group also reported significantly better control of cardiac risk factors including smoking (χ 2  = 4.709,  p  = 0.030), low-density lipoprotein (χ 2  = 4.160,  p  = 0.041), body mass index (χ 2  = 3.886,  p  = 0.049) and exercise (χ 2  = 10.096,  p  = 0.001).
","['patients with acute myocardial infarction (AMI) undergoing', 'Chinese patients with acute myocardial infarction undergoing percutaneous coronary intervention', 'patients with AMI undergoing PCI', '112 participants recruited from a tertiary hospital in China', 'Chinese patients with AMI undergoing PCI']","['nurse-led individualized self-management program (NISMP', 'nurse-led individualized self-management program', 'percutaneous coronary intervention (PCI', 'NISMP', 'self-management intervention', 'NISMP, which includes six group-based education sessions, a face-to-face individual consultation, and 12-month telephone follow-ups']","['health behaviors, control of cardiac risk factors, and health-related quality of life (HRQoL', 'health behaviors, control of cardiac risk factors, and HRQoL', 'low-density lipoprotein', 'body mass index', 'health behaviors and HRQoL', 'control of cardiac risk factors including smoking']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C0018687'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",112.0,0.0308392,"Compared to the control group, the participants in the intervention group also reported significantly better control of cardiac risk factors including smoking (χ 2  = 4.709,  p  = 0.030), low-density lipoprotein (χ 2  = 4.160,  p  = 0.041), body mass index (χ 2  = 3.886,  p  = 0.049) and exercise (χ 2  = 10.096,  p  = 0.001).
","[{'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Cardiology Department, First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Juanli', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Cardiology Department, First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': ""Xi'an Jiaotong University Health Science Center, China.""}, {'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119889197']
250,32266683,A Pilot Randomised Control Trial of Digitally-Mediated Social Stories for Children on the Autism Spectrum.,"Social stories is a widely used intervention for children on the autism spectrum, particularly within an educational context. To date, systematic reviews and meta analyses of the research evaluating social stories has produced mixed results, often due to a lack of methodological rigour and variability in the development and delivery of the social stories. To address the gap in methodological rigour, a pilot Randomised Control Trial (RCT) was conducted, incorporating a social stories intervention group (n = 9 children on the autism spectrum) and an attentional control group who received a poem (n = 6 children on the autism spectrum) using a digital platform to address variability. Digitally-mediated social stories were found to be effective in producing beneficial changes in behaviour outcomes, which were sustained at a six-week follow up.",2020,"Digitally-mediated social stories were found to be effective in producing beneficial changes in behaviour outcomes, which were sustained at a six-week follow up.","['Children on the Autism Spectrum', 'group (n\u2009=\u20099 children on the autism spectrum']","['social stories intervention', 'attentional control group who received a poem (n\u2009=\u20096 children on the autism spectrum', 'Digitally-Mediated Social Stories']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",[],9.0,0.0265617,"Digitally-mediated social stories were found to be effective in producing beneficial changes in behaviour outcomes, which were sustained at a six-week follow up.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hanrahan', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brosnan', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK. Pssmjb@bath.ac.uk.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04490-8']
251,32253548,Additional benefits of multiple-dose tranexamic acid to anti-fibrinolysis and anti-inflammation in total knee arthroplasty: a randomized controlled trial.,"BACKGROUND


Consensus is lacking regarding the dose and timing of tranexamic acid (TXA). The aim of this study was to determine whether multiple-dose intravenous TXA further reduced blood loss and attenuated inflammation after total knee arthroplasty (TKA).
MATERIALS AND METHODS


We prospectively studied four regimens on TXA: no TXA (A), before incision, 3, 6, and 12 h later (B), before incision, 3, 6, 12, and 18 h later (C) and before incision, 3, 6, 12, 18, and 24 h later (D). The primary outcome was hidden blood loss (HBL). Other outcome measurements such as total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications were also compared.
RESULTS


The mean HBL and TBL were significantly lower in Group D than in Groups C, B and A. The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively. The VAS score on postoperative days 1 and 3 (POD1 and POD3) was significantly lower in Group D than in Groups C, B and A. There was no significant difference in LOS among groups. No patient underwent blood transfusion. No episodes of deep venous thrombosis or pulmonary embolism occurred in all the groups.
CONCLUSION


The repeated doses of TXA up to 24 h can further diminish HBL, provide additional fibrinolysis and inflammation control and ameliorate postoperative pain following TKA.
LEVEL OF EVIDENCE


I.",2020,"The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively.","['total knee arthroplasty (TKA', 'total knee arthroplasty']","['tranexamic acid (TXA', 'TXA: no TXA', 'tranexamic acid', 'TXA']","['mean HBL and TBL', 'VAS score on postoperative days 1 and 3 (POD1 and POD3', 'level of inflammatory factors and fibrinolysis parameters', 'blood loss', 'deep venous thrombosis or pulmonary embolism', 'LOS', 'total blood loss (TBL), intraoperative blood loss (IBL), fibrinolysis parameters [fibrin(-ogen) degradation products, D-dimer], inflammatory factors (C-reactive protein, interleukin-6), visual analog scale (VAS) score, transfusion rate, length of stay (LOS) and complications', 'hidden blood loss (HBL']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206624', 'cui_str': 'Hepatoblastoma'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0722236', 'cui_str': 'Ogen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205262', 'cui_str': 'Occult'}]",,0.0903729,"The level of inflammatory factors and fibrinolysis parameters were significantly lower in Group D than in Groups C, B and A at 24 and 72 h postoperatively.","[{'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People's Republic of China. huangw511@163.com.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China. peifux@126.com.""}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03442-2']
252,32092208,Effects of caffeine on neuromuscular function in a non-fatigued state and during fatiguing exercise.,"NEW FINDINGS


What is the central question of the study? What are the effects of caffeine on neuromuscular function in a non-fatigued state and during fatiguing exercise? What is the main finding and its importance? In a non-fatigued state, caffeine decreased the duration of the silent period evoked by transcranial magnetic stimulation. Caffeine-induced reduction of inhibitory mechanisms in the central nervous system before exercise was associated with an increased performance. Individuals who benefit from caffeine ingestion may experience lower perception of effort during exercise and an accelerated recovery of M-wave amplitude postfatigue. This study elucidates the mechanisms of action of caffeine and demonstrates that inter-individual variability of its effects on neuromuscular function is a fruitful area for further work.
ABSTRACT


Caffeine enhances exercise performance, but its mechanisms of action remain unclear. In this study, we investigated its effects on neuromuscular function in a non-fatigued state and during fatiguing exercise. Eighteen men participated in this randomized, double-blind, placebo-controlled crossover trial. Baseline measures included plantarflexion force, drop jump, squat jump, voluntary activation of triceps surae muscle, soleus muscle contractile properties, M-wave, α-motoneuron excitability (H-reflex), corticospinal excitability, short-interval intracortical inhibition, intracortical facilitation, silent period evoked by transcranial magnetic stimulation (SP) and plasma potassium and caffeine concentrations. Immediately after baseline testing, participants ingested caffeine (6 mg·kg -1  ) or placebo. After a 1-h rest, baseline measures were repeated, followed by a fatiguing stretch-shortening cycle exercise (sets of 40 bilateral rebound jumps on a sledge apparatus) until task failure. Neuromuscular testing was carried out throughout the fatigue protocol and afterwards. Caffeine enhanced drop jump height (by 4.2%) and decreased the SP (by 12.6%) in a non-fatigued state. A caffeine-related decrease in SP and short-interval intracortical inhibition before the fatiguing activity was associated with an increased time to task failure. The participants who benefitted from an improved performance on the caffeine day reported a significantly lower sense of effort during exercise and had an accelerated postexercise recovery of M-wave amplitude. Caffeine modulates inhibitory mechanisms of the CNS, recovery of M-wave amplitude and perception of effort. This study lays the groundwork for future examinations of differences in caffeine-induced neuromuscular changes between those who are deemed to benefit from caffeine ingestion and those who are not.",2020,"The participants who benefited from an improved performance on the caffeine day, reported a significantly lower sense of effort during exercise and had an accelerated post-exercise recovery of M-wave amplitude.",['Methods Eighteen males participated'],"['placebo', 'caffeine ingestion', 'caffeine', 'Caffeine']","['time to task failure', 'plantarflexion force, drop jump, squat jump, voluntary activation of triceps surae muscle, soleus muscle contractile properties, M-wave, alpha-motoneuron excitability (H-reflex), corticospinal excitability, short-interval intracortical inhibition (SICI), intracortical facilitation (ICF), silent period evoked by transcranial magnetic stimulation (SP) and plasma potassium and caffeine concentration', 'SP and SICI', 'neuromuscular function', 'SP']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0242694', 'cui_str': 'Soleus Muscle'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026609', 'cui_str': 'Motoneurons'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0858155', 'cui_str': 'Plasma potassium'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031843', 'cui_str': 'function'}]",18.0,0.0921613,"The participants who benefited from an improved performance on the caffeine day, reported a significantly lower sense of effort during exercise and had an accelerated post-exercise recovery of M-wave amplitude.","[{'ForeName': 'Ricardo N O', 'Initials': 'RNO', 'LastName': 'Mesquita', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Cronin', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kyröläinen', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Hintikka', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Avela', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",Experimental physiology,['10.1113/EP088265']
253,32253895,Effect of acupuncture in physiological parameters and endurance running performance.,"BACKGROUND


Few studies have examined the effect of acupuncture (AC) treatment in aerobic capacity and endurance performance in healthy adults. Thus, the aim of the present study was to evaluate the effects of AC on selected physiological parameters and 3 km running performance.
METHODS


Twenty-four healthy subjects with low to moderate aerobic capacity participated in the study and randomly assigned in two groups: AC group (ACG - N.=14) and control group (CG - N.=10). The subjects completed an incremental test to exhaustion and a 3 km race on a treadmill to evaluate their physiological responses and endurance running performance respectively, prior and after 4 weeks (8 sessions, twice a week) of acupuncture treatment.
RESULTS


AC treatment had a significant main effect in T3km [F(1, 21)=7.173, P=0.014, partial η2=0.255], as well as in VT [F(1, 21)=8.476, P=0.008, partial η2=0.288] and HRmax@3km [F(1, 21)=4.930, P=0.038, partial η2=0.190], after controlling for the effect of the pre-test, while no other significant main effects were detected.
CONCLUSIONS


Healthy physically active adults significantly improved their endurance running performance after 4 weeks of AC treatment. This is mainly due to the enhancement of the speed corresponding with VT, comparing with their baseline values.",2020,"RESULTS


AC treatment had a significant main effect in T3km [F(1, 21)=7,173, p=0,014, partial η2=0,255], as well as in VT [F(1, 21)=8,476, p=0,008, partial η2=0,288] and HRmax@3km [F(1, 21)=4,930, p=0,038, partial η2=0,190], after controlling for the effect of the pre-test, while no other significant main effects were detected.
","['healthy adults', 'Healthy physically active adults', 'Twenty four healthy subjects with low to moderate aerobic capacity participated in the study and randomly assigned in two groups']","['AC group (ACG - N=14) and control group (CG - N=10', 'acupuncture treatment', 'acupuncture', 'acupuncture (AC']","['physiological parameters and endurance running performance', 'endurance running performance', 'aerobic capacity and endurance performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0050397', 'cui_str': 'acceleratory factor from growth hormone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",24.0,0.0638065,"RESULTS


AC treatment had a significant main effect in T3km [F(1, 21)=7,173, p=0,014, partial η2=0,255], as well as in VT [F(1, 21)=8,476, p=0,008, partial η2=0,288] and HRmax@3km [F(1, 21)=4,930, p=0,038, partial η2=0,190], after controlling for the effect of the pre-test, while no other significant main effects were detected.
","[{'ForeName': 'Angela Α', 'Initials': 'AΑ', 'LastName': 'Tsopanidou', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece - angelatsopanidou@hotmail.com.'}, {'ForeName': 'Prokopios Ε', 'Initials': 'PΕ', 'LastName': 'Chatzakis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}, {'ForeName': 'Panagiotis V', 'Initials': 'PV', 'LastName': 'Drimalas', 'Affiliation': 'Grigore T. Popa University of Medicine and Pharmacy, Iasi, Romania.'}, {'ForeName': 'Ioannis S', 'Initials': 'IS', 'LastName': 'Stavridis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Dallas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}, {'ForeName': 'Elias G', 'Initials': 'EG', 'LastName': 'Zacharogiannis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University, Athens, Greece.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10325-6']
254,32253896,Effects of different multicomponent training methods on functional parameters in physically-active older women.,"BACKGROUND


Negative functionality changes are among the effects of aging. The multicomponent training performed on conventional machines or with new implements and features directed to daily activities is strongly recommended among attenuation strategies. However, the efficiency of both types of training is not yet clear in the recent literature. The aim was to compare the effects of different multicomponent training methods on functional parameters in older women.
METHODS


Thirty-seven volunteers were randomly selected into the functional multicomponent training (MFT: N.=15), traditional multicomponent training (MTT: N.=14) and control group (CG: N.=8). They were assessed in the tests: Six-Minute Walk Test (6MWT), Ten-Minute Fast Walking Test (10FWT), Timed Up and Go test (TUG), Functional Reach Test (FRT), Ankle Test (AKT), Sit To Stand Modified test (STSM), and quality of life (QOL). ANOVA (3×2) followed by the Bonferroni post-hoc was used, adopting P≤0.05 for statistical significance.
RESULTS


When compared pre-post values, MFT showed significant differences in all functional tests evaluated (AKT: P<0.01; STSM: P<0.01; FRT: P<0.01; QOF: P<0.01; 10FWT: P<0.01; 6MWT: P<0.01; TUG: P<0.05). In the same comparison, MTT showed a significant change in all tests (AKT: P<0.01; STSM: P<0.01; FRT: P<0.01; QOF: P<0.05; 6MWT: P≤0.05; TUG: P<0.05) except 10FWT. When compared to CG, MFT showed a significant difference in all walking tests and MTT showed a better performance in 10FWT and TUG.
CONCLUSIONS


Both experimental protocols were effective to improve functional parameters in older women. However, the MFT was performed better in most tests that required efficiency in gait ability.",2020,"When compared to CG, MFT showed a significant difference in all walking tests and MTT showed a better performance in 10FWT and TUG.
","['Thirty-seven volunteers', 'older women', 'physically active older women']","['multicomponent training methods', 'MFT', 'functional multicomponent training (MFT: n=15), traditional multicomponent training (MTT: n=14) and control group (CG']","['tests: 6-minute walk test (6MWT), 10-minute fast walking test (10FWT), time up and go (TUG), functional reach test (FRT), ankle test (AKT), sit to stand modified (STSM) and quality of life (QOF', 'functional parameters']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0647210', 'cui_str': 'monooxyethylene trimethylolpropane tristearate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",37.0,0.0254339,"When compared to CG, MFT showed a significant difference in all walking tests and MTT showed a better performance in 10FWT and TUG.
","[{'ForeName': 'Leandro H', 'Initials': 'LH', 'LastName': 'Brandão', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil - leeo.henriquee01@gmail.com.'}, {'ForeName': 'Antônio G', 'Initials': 'AG', 'LastName': 'Resende-Neto', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Iohanna G', 'Initials': 'IG', 'LastName': 'Fernandes', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Vasconcelos', 'Affiliation': 'Postgraduate Program of Physiology, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Albernon C', 'Initials': 'AC', 'LastName': 'Nogueira', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}, {'ForeName': 'Marzo E', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Postgraduate Program of Physical Education, Federal University of Sergipe, São Cristovão, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10327-X']
255,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
256,32248089,Brain-Computer Interface-Based Soft Robotic Glove Rehabilitation for Stroke.,"OBJECTIVE


This randomized controlled feasibility study investigates the ability for clinical application of the Brain-Computer Interface-based Soft Robotic Glove (BCI-SRG) incorporating activities of daily living (ADL)-oriented tasks for stroke rehabilitation.
METHODS


Eleven recruited chronic stroke patients were randomized into BCI-SRG or Soft Robotic Glove (SRG) group. Each group underwent 120-minute intervention per session comprising 30-minute standard arm therapy and 90-minute experimental therapy (BCI-SRG or SRG). To perform ADL tasks, BCI-SRG group used motor imagery-BCI and SRG, while SRG group used SRG without motor imagery-BCI. Both groups received 18 sessions of intervention over 6 weeks. Fugl-Meyer Motor Assessment (FMA) and Action Research Arm Test (ARAT) scores were measured at baseline (week 0), post- intervention (week 6), and follow-ups (week 12 and 24). In total, 10/11 patients completed the study with 5 in each group and 1 dropped out.
RESULTS


Though there were no significant intergroup differences for FMA and ARAT during 6-week intervention, the improvement of FMA and ARAT seemed to sustain beyond 6-week intervention for BCI-SRG group, as compared with SRG control. Incidentally, all BCI-SRG subjects reported a sense of vivid movement of the stroke-impaired upper limb and 3/5 had this phenomenon persisting beyond intervention while none of SRG did.
CONCLUSION


BCI-SRG suggested probable trends of sustained functional improvements with peculiar kinesthetic experience outlasting active intervention in chronic stroke despite the dire need for large-scale investigations to verify statistical significance.
SIGNIFICANCE


Addition of BCI to soft robotic training for ADL-oriented stroke rehabilitation holds promise for sustained improvements as well as elicited perception of motor movements.",2020,"Though there were no significant intergroup differences for FMA and ARAT during 6-week intervention, the improvement of FMA and ARAT seemed to sustain beyond 6-week intervention for BCI-SRG group, as compared with SRG control.","['Eleven recruited chronic stroke patients', 'Stroke']","['Brain-Computer Interface-based Soft Robotic Glove (BCI-SRG', 'BCI-SRG or Soft Robotic Glove (SRG', 'Brain-Computer Interface-based Soft Robotic Glove Rehabilitation', '120-minute intervention per session comprising 30-minute standard arm therapy and 90-minute experimental therapy (BCI-SRG or SRG']",['Fugl-Meyer Motor Assessment (FMA) and Action Research Arm Test (ARAT'],"[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4046010', 'cui_str': 'Soft Robotics'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0949266', 'cui_str': 'Investigational Therapies'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}]",11.0,0.0229766,"Though there were no significant intergroup differences for FMA and ARAT during 6-week intervention, the improvement of FMA and ARAT seemed to sustain beyond 6-week intervention for BCI-SRG group, as compared with SRG control.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': ''}, {'ForeName': 'Hwa Sen', 'Initials': 'HS', 'LastName': 'Lai', 'Affiliation': ''}, {'ForeName': 'Pui Kit', 'Initials': 'PK', 'LastName': 'Tam', 'Affiliation': ''}, {'ForeName': 'Ka Yin', 'Initials': 'KY', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Kai Kei', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Raye Chen-Hua', 'Initials': 'RC', 'LastName': 'Yeow', 'Affiliation': ''}, {'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': ''}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': ''}]",IEEE transactions on bio-medical engineering,['10.1109/TBME.2020.2984003']
257,32141709,"Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).","OBJECTIVE


To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits.
DESIGN


Randomised controlled trial.
SETTING


Thirty-three UK hospitals.
POPULATION


Women having surgery for recurrent prolapse.
METHODS


Women recruited using remote randomisation.
MAIN OUTCOME MEASURES


Prolapse symptoms, condition-specific quality-of-life and serious adverse effects.
RESULTS


A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision.
CONCLUSIONS


We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.
TWEETABLE ABSTRACT


There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.",2020,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"['Women having surgery for recurrent prolapse', 'women undergoing repeat prolapse surgery', 'Women recruited using remote randomisation', '33 UK hospitals', 'women having repeat anterior or posterior prolapse surgery']","['standard (native tissue) repair against synthetic mesh inlays or mesh kits', 'Mesh inlay, mesh kit or native tissue repair']","['Mean Pelvic Organ Prolapse Symptom Score', 'surgical revision', 'prolapse symptoms', 'Prolapse symptoms, condition specific quality-of-life and serious adverse effects', 'Cumulative mesh exposure rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",4.0,0.336306,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"[{'ForeName': 'Cma', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Cooper', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Freeman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Arb', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Montgomery', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16197']
258,32020676,"Exercise improves adiposopathy, insulin sensitivity and metabolic syndrome severity independent of intensity.","NEW FINDINGS


What is the central question of this study? What are the effects of work-matched continuous versus high-intensity interval training for 2 weeks on adiposopathy and cardiometabolic risk in obese adults with prediabetes? What is the main finding and its importance? Independent of intensity, short-term exercise improves adiposopathy and insulin sensitivity. While both exercise intensities reduced fasting leptin concentrations and metabolic syndrome severity, only interval training elevated total adiponectin. In contrast to previous work, neither condition altered high-molecular weight adiponectin. Collectively, these data suggest that short-term exercise can improve adipokine profiles, which may aid in reducing cardiometabolic risk prior to clinically meaningful weight loss in adults with prediabetes.
ABSTRACT


Individuals with prediabetes who are overweight and obese are at an increased risk of developing endocrine disruption of fat tissue, known as adiposopathy. While short-term exercise improves adipokine profiles, the effects of exercise intensity when matched for energy expenditure on adiposopathy are unknown. We hypothesized that high-intensity exercise would elicit greater changes in adiposopathy compared to moderate exercise. Twenty-eight overweight and obese adults (age: 60.9 ± 8.4 years; BMI: 33.0 ± 5.4 kg m -2  ) with prediabetes were randomized to twelve 60-min sessions of either moderate-continuous (CONT; n = 14) or high-intensity interval (INT; n = 14) exercise training. Total and high molecular weight (HMW) adiponectin and leptin were collected to assess adiposopathy (ratio of total adiponectin to leptin; A/L). Insulin sensitivity (SI IS  ) was determined using a 75 g oral glucose tolerance test before and after training. Cardiometabolic risk factors were measured and a z-score was calculated to determine metabolic syndrome (MetS) severity. CONT and INT increased A/L (P < 0.01) and decreased leptin (P < 0.01) and MetS severity (P = 0.04). Neither intervention altered circulating levels of HMW adiponectin (P = 0.76) and only INT increased total adiponectin levels (P = 0.02). Both intensities increased insulin sensitivity (P < 0.01), which was associated with improvements in A/L (r = 0.47, P = 0.01). Additionally, increases in A/L tended to relate to decreased MetS severity (r = -0.36, P = 0.09). Short-term exercise intensity, when matched for energy expenditure, does not differentially affect improvements in adiposopathy in overweight and obese adults with prediabetes. Further, 12 bouts of exercise improved insulin sensitivity and MetS severity, suggesting that improving adipokine profiles may aid in reducing cardiometabolic risk.",2020,Neither intervention altered circulating levels of HMW adiponectin (P = 0.76) and only INT increased total adiponectin levels (P = 0.02).,"['adults with prediabetes', 'Methods Twenty-eight overweight and obese adults (Age: 60.9\xa0±\xa08.4 yrs; BMI: 33.0\xa0±\xa05.4\xa0kg/m 2  ) with prediabetes', 'obese adults with prediabetes', 'overweight and obese adults with prediabetes', 'Individuals with prediabetes who are overweight and obese']","['work-matched continuous versus high-intensity interval training', 'moderate-continuous (CONT; n\xa0=\xa014) or high-intensity interval (INT; n\xa0=\xa014) exercise training']","['Cardiometabolic risk factors', 'adiposopathy, insulin sensitivity and metabolic syndrome severity independent of exercise intensity', 'insulin sensitivity', 'Total and high molecular weight (HMW) adiponectin and leptin', 'cardiometabolic risk', 'adiposopathy and cardiometabolic risk', 'adiposopathy and insulin sensitivity', 'Insulin sensitivity (SI IS  ', 'MetS severity', 'total adiponectin levels', 'leptin', 'fasting leptin concentrations and metabolic syndrome severity, only interval training elevated total adiponectin', 'insulin sensitivity and MetS severity', 'adiposopathy (ratio of total adiponectin to leptin (A/L', 'circulating levels of HMW adiponectin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin (substance)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",28.0,0.0204175,Neither intervention altered circulating levels of HMW adiponectin (P = 0.76) and only INT increased total adiponectin levels (P = 0.02).,"[{'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Natalie Zm', 'Initials': 'NZ', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, USA.'}]",Experimental physiology,['10.1113/EP088158']
259,31181140,"Scar Quality of Skin Graft Borders: A Prospective, Randomized, Double-Blinded Evaluation.","Prominent scars may remain around the border of a mature skin graft (SG) at the interface of the SG with normal skin. The border of a SG may be constructed by either exactly approximating (A) or slightly overlapping (O) the edge of the SG on the wound margin. The purpose of this study was to evaluate whether A or O affects the quality of the border scar of SGs applied to burn patients. This prospective study was a within-border design in which adult burn patients requiring SGs served as their own control. Half of each study border was fashioned using O and the immediately adjacent other half was made using A. We randomly assigned O or A to the proximal or distal halves of vertical borders and the medial and lateral halves of horizontal borders. Both halves of the study border were identically fixated with staples or sutures and were managed in the same fashion postoperatively. Blinded evaluations at 3, 6, and 12 months of O and A borders were performed using the Vancouver Scar Scale (VSS), the observer component of the Patient and Observer Scar Assessment Scale (POSAS), and a global binary assessment of which half of the study border ""looked better."" Blinded patients also rated each half of the study border with a 10-point Likert scale. Values are reported as the mean ± SD or median (interquartile range), as appropriate. There were 34 borders studied in 15 subjects (46.7% female, age 29 [22,57], % TBSA burn 9.7 ± 5.3, and no inhalation injuries). Study borders were constructed at 7 (5,11) days postburn, had a total length of 12 (9.3,14.5) cm, and all involved split thickness SGs of thickness 13 (12,14)/1000th of an inch. Sheet grafts were applied in 27% and meshed grafts in 73%. SGs were applied immediately after excision in 75% or after allografting in 25%. Border scars matured between 3 and 12 months with reductions in total VSS from 8 (7,8) to 4 (3,6) for O borders (P < .001) and from 8 (7,9) to 4 (1,6) for A borders (P < .001). However, there were no significant differences between O and A borders in total VSS at 3 months (P = .165), 6 months (P = .602), and 12 months (P = .358) or in total OSAS at 3 months (P = .681), 6 months (P = .890), or 12 months (P = .601). At 12 months, 60% of O borders and 40% of A borders were globally rated as ""better"" (P = .258). There were no significant differences in the patients' subjective ratings of the O and A borders at 3 months (P = .920), 6 months (P = .960), and 12 months (P = .66). The scar quality at the border of a skin graft does not appear to be affected by the surgical technique used to construct the border at the time of grafting.",2019,"There were no significant differences in the patients' subjective ratings of the O and A borders at 3 months (p=0.920), 6 months (p=0.960), and 12 months (p=0.66).
","['adult burn patients requiring SGs served as their own control', '15 subjects [46.7% female, age 29 (22,57), % TBSA burn 9.7 ± 5.3, and no inhalation injuries', 'burn patients']",[],"['total VSS', 'Scar Quality of Skin Graft Borders', 'total OSAS', ""patients' subjective ratings of the O and A borders"", 'Vancouver Scar Scale (VSS), the observer component of the Patient and Observer Scar Assessment Scale (POSAS), and a global binary assessment of which half of the study border ""looked better', 'scar quality', 'Border scars']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0745334', 'cui_str': 'Injury to respiratory system due to inhaled substance (disorder)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",15.0,0.0307799,"There were no significant differences in the patients' subjective ratings of the O and A borders at 3 months (p=0.920), 6 months (p=0.960), and 12 months (p=0.66).
","[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Zuo', 'Affiliation': 'Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Umraw', 'Affiliation': 'Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cartotto', 'Affiliation': 'Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/irz087']
260,32270185,Association Between Improved Mobility and Distal Health Outcomes.,"BACKGROUND


We examined the association between improved mobility and distal health outcomes in older adults using secondary analysis of data from a cluster-randomized controlled group exercise trial.
METHODS


Participants were 303 men and women aged ≥65 and older in 32 independent living facilities, senior apartments, and community centers who participated in 12-week group exercise interventions. Included were those who completed ≥1 follow-up phone call regarding outcomes assessment in the following year. Gait speed and 6-minute walk distance (6MWD) were assessed at baseline and immediately after 12-week interventions to determine mobility performance change status. Falls, emergency department (ED) visits, and hospitalizations were assessed monthly for 12 months following the end of interventions via interactive voice response phone calls. Incident rate ratios (IRRs) were calculated to quantify incidence of adverse outcomes with respect to mobility performance change.
RESULTS


Each 0.05 m/s increase in gait speed resulted in an 11% reduction in falls (IRR = 0.89; 95% confidence interval [CI], 0.84-0.94; p < .0001); a similar decrease was seen for each 20 m increase in 6MWD (IRR = 0.89; 95% CI, 0.83-0.93; p = .0003). Those who improved gait speed had 61 falls per 1,000 person-months versus 135 in those who had no change/a decline. Those who improved 6MWD had 67 falls per 1,000 person-months versus 110 per 1,000 person-months in those who had no change/a decline. Differences in ED visits and hospitalizations were not statistically significant.
CONCLUSION


Improvements in mobility performance are associated with lower incidence of future falls. Given the exploratory nature of the findings, further investigation is warranted.",2020,Those who improved gait speed had 61 falls per 1000 person-months versus 135 in those who had no change/a decline.,"['Participants were 303 men and women aged ≥65 years in 32 independent living facilities, senior apartments, and community centers who participated in 12-week group', 'older adults']",['exercise interventions'],"['6MWD', 'Incident rate ratios (IRRs', 'Gait speed and six-minute walk distance (6MWD', 'mobility performance', 'mobility and distal health outcomes', 'Falls, emergency department (ED) visits, and hospitalizations', 'gait speed', 'ED visits and hospitalizations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0457933', 'cui_str': 'Apartment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",303.0,0.0736643,Those who improved gait speed had 61 falls per 1000 person-months versus 135 in those who had no change/a decline.,"[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Shuman', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Coyle', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'Van Swearingen', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pennsylvania.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa086']
261,32270385,Cross-Cultural Adaptation to Australia of the KONTAKT© Social Skills Group Training Program for Youth with Autism Spectrum Disorder: A Feasibility Study.,"This study investigated the feasibility and cultural validity of KONTAKT©, a manualised social skills group training, in improving the social functioning of adolescents with autism spectrum disorder (ASD). KONTAKT© was delivered to 17 adolescents (m age  = 14.09, SD age  = 1.43; 70% male) with ASD over sixteen 90 min sessions. A pre-test post-test design evaluated changes in personally meaningful social goals, symptom severity, quality of life, interpersonal efficacy, social anxiety, loneliness, and facial emotion recognition at pre, post and 3 months follow-up. Focus groups were conducted post intervention. Findings indicate that KONTAKT© may support Australian adolescents with ASD in achieving their personally meaningful social goals. This study resulted in finalisation of KONTAKT© in preparation for evaluation of its efficacy in a randomised controlled trial (Australian New Zealand Clinical Registry (ANZCTR): ACTRN12617001117303, ClinicalTrials.gov: NCT03294668).",2020,"©, a manualised social skills group training, in improving the social functioning of adolescents with autism spectrum disorder (ASD).","['adolescents with autism spectrum disorder (ASD', 'Youth with Autism', '17 adolescents (m age \u2009=\u200914.09, SD age \u2009=\u20091.43; 70% male) with ASD over sixteen 90\xa0min sessions', 'Australian adolescents with ASD', 'Spectrum Disorder']","['manualised social skills group training', 'KONTAKT']","['personally meaningful social goals, symptom severity, quality of life, interpersonal efficacy, social anxiety, loneliness, and facial emotion recognition']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]",,0.0282831,"©, a manualised social skills group training, in improving the social functioning of adolescents with autism spectrum disorder (ASD).","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Afsharnejad', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Falkmer', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Black', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Alach', 'Affiliation': 'Autism Association of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lenhard', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fridell', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet & Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Coco', 'Affiliation': ""Center of Neurodevelopmental Disorders (KIND), Centre for Psychiatry Research, Division of Neuropsychiatry, Department of Women's and Children's Health, Karolinska Institutet & Child and Adolescent Psychiatry, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Milne', 'Affiliation': 'Autism Association of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Nigel T M', 'Initials': 'NTM', 'LastName': 'Chen', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Bölte', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Girdler', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, WA, Australia. Sonya.girdler@curtin.edu.au.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04477-5']
262,31567873,Retrospective analysis of phytoSERM for management of menopause-associated vasomotor symptoms and cognitive decline: a pilot study on pharmacogenomic effects of mitochondrial haplogroup and APOE genotype on therapeutic efficacy.,"OBJECTIVE


PhytoSERM is a selective estrogen receptor beta (ERβ) modulator comprised of three phytoestrogens: genistein, daidzein, and S-equol. The PhytoSERM formulation promotes estrogenic action in the brain while largely inactive or inhibitory in reproductive tissue. A phase Ib/IIa clinical trial (ClinicalTrial.gov ID: NCT01723917) of PhytoSERM demonstrated safety and pharmacokinetics profile of PhytoSERM. While this study was not powered for efficacy analysis, we conducted a pilot, retrospective analysis to identify potential responders to PhytoSERM treatment, and to determine the optimal populations to pursue in a phase II clinical trial of efficacy of the PhytoSERM formulation.
METHODS


In this retrospective analysis involving 46 participants (n = 16, placebo; n = 18, 50 mg/d PhytoSERM; and n = 12, 100 mg/d PhytoSERM), the therapeutic effect of PhytoSERM was stratified by 2 genetic risk modulators for Alzheimer's disease: mitochondrial haplogroup and APOE genotype.
RESULTS


Our retrospective responder analysis indicated that participants on 50 mg of daily PhytoSERM (PS50) for 12 weeks significantly reduced hot flash frequency compared with their baseline (mean [95% CI])-1.61, [-2.79, -0.42], P = 0.007). Participants on 50 mg of PhytoSERM also had significantly greater reduction in hot flash frequency at 12 weeks compared with the placebo group (-1.38, -0.17 [median PS50, median placebo], P = 0.04). Fifty milligrams of daily PhytoSERM also preserved cognitive function in certain aspects of verbal learning and executive function. Our analysis further suggests that mitochondrial haplogroup and APOE genotype can modify PhytoSERM response.
CONCLUSION


Our data support a precision medicine approach for further development of PhytoSERM as a safe and effective alternative to hormone therapy for menopause-associated hot flash and cognitive decline. While definitive determination of PhytoSERM efficacy is limited by the small sample size, these data provide a reasonable rationale to extend analyses to a larger study set powered to address statistical significance.",2020,"Participants on 50 mg of PhytoSERM also had significantly greater reduction in hot flash frequency at 12 weeks compared with the placebo group (-1.38, -0.17",['46 participants (n\u200a=\u200a16'],"['daily PhytoSERM', 'phytoSERM', 'mitochondrial haplogroup and APOE genotype', 'placebo', 'PhytoSERM', 'phytoestrogens: genistein, daidzein, and S-equol']","['therapeutic efficacy', 'hot flash frequency', 'verbal learning and executive function']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C0057090', 'cui_str': 'diadzein'}, {'cui': 'C3892880', 'cui_str': '(R) - EQUOL'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",46.0,0.17991,"Participants on 50 mg of PhytoSERM also had significantly greater reduction in hot flash frequency at 12 weeks compared with the placebo group (-1.38, -0.17","[{'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yin', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Roberta D', 'Initials': 'RD', 'LastName': 'Brinton', 'Affiliation': 'School of Pharmacy, University of Southern California, Los Angeles, CA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001418']
263,32217524,Does foot mobility affect the outcome in the management of patellofemoral pain with foot orthoses versus hip exercises? A randomised clinical trial.,"OBJECTIVES


To test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility.
METHODS


A two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18-40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility ( high  ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as  much better  or  better  on a patient-perceived 7-point scale at 12 weeks.
RESULTS


Of 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with  high  (6/21 vs 9/20; 29% vs 45%, respectively) or  low  (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).
CONCLUSION


Midfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain.
TRIAL REGISTRATION NUMBER


ACTRN12614000260628.",2020,"This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).
","['Australia and Denmark', 'Participants (18-40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running']","['hip exercises and (ii) if hip exercises', 'foot orthoses versus hip exercises', 'foot orthoses or hip exercises']","['success rate', 'success rates', 'midfoot width mobility']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1298634', 'cui_str': 'Insidious onset'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C0454362', 'cui_str': 'Hip exercises (regime/therapy)'}, {'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}]","[{'cui': 'C0932074', 'cui_str': 'Midfoot region of foot (body structure)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",218.0,0.229805,"This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': 'Sports and Exercise Science Research Institute, Ulster University, Belfast, UK.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Center for General Practice in Aalborg, Department of Clinical Medicine, Aalborg, Denmark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Claus', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McPoil', 'Affiliation': 'School of Physical Therapy, Regis University, Denver, Colorado, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nee', 'Affiliation': 'School of Physical Therapy, Pacific University, Hillsboro, Oregon, USA.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kasza', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bill T', 'Initials': 'BT', 'LastName': 'Vicenzino', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia b.vicenzino@uq.edu.au.'}]",British journal of sports medicine,['10.1136/bjsports-2019-100935']
264,32143828,Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial.,"PURPOSE


To compare early postoperative intraocular pressure (IOP) in patients who underwent cataract surgery alone with those who underwent cataract surgery combined with implantation of a Hydrus Microstent (HMS) (Ivantis, Irvine, CA).
DESIGN


Subanalysis of data from the randomized controlled HORIZON trial, a multicenter trial including 26 US and 12 international sites.
PARTICIPANTS


Participants with mild/moderate primary open-angle glaucoma (POAG) and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications.
METHODS


A total of 556 subjects were randomized in a 2:1 ratio to undergo cataract surgery with placement of the HMS versus cataract surgery alone (no microstent [NMS]). All eyes were washed out of IOP-lowering medications before surgery and remained unmedicated until surgery. No IOP-lowering prophylaxis was used postoperatively. Comprehensive eye examination including measurement of intraocular pressure was conducted on postoperative day (POD) 1, week 1, and month 1.
MAIN OUTCOME MEASURES


Postoperative IOP >40 mmHg was analyzed as the primary outcome. Incidence of IOP increase >10 mmHg above baseline, unmedicated IOP, and mean IOP were analyzed as secondary outcomes.
RESULTS


A total of 369 eyes were randomized to the HMS group, and 187 eyes were randomized to cataract surgery alone. The HMS and NMS groups did not differ with respect to baseline demographic or ocular characteristics. On POD1, the incidence of IOP spike >40 mmHg was significantly higher at 14.4% in the NMS group compared with 1.4% in the HMS group (P < 0.001). The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001). IOP in the NMS group was significantly higher than in the HMS group (27.6 vs. 17.0 mmHg, P < 0.001). In multivariable logistic regression analysis, higher baseline IOP predicted higher odds of POD1 IOP spike >40 mmHg, whereas the presence of HMS was associated with a lower likelihood of postoperative IOP spike.
CONCLUSIONS


The addition of an HMS at the time of cataract surgery lowered the risk of markedly elevated IOP in the early postoperative period in patients with glaucoma.",2020,"The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001).","['patients who underwent cataract surgery alone with those who underwent', 'Participants with mild/moderate primary open-angle glaucoma (POAG) and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications', 'after Cataract Surgery', 'A total of 556 subjects', '26 US and 12 international sites', 'A total of 369 eyes were randomized to the HMS group, and 187 eyes', 'patients with glaucoma']","['cataract surgery alone (no microstent [NMS', 'cataract surgery with placement of the HMS', ""Schlemm's Canal Microstent"", 'NMS', 'HMS', 'cataract surgery alone', 'cataract surgery combined with implantation of a Hydrus Microstent (HMS) (Ivantis, Irvine, CA']","['Incidence of IOP increase >10 mmHg above baseline, unmedicated IOP, and mean IOP', 'early postoperative intraocular pressure (IOP', 'Early Postoperative Intraocular Pressure', 'IOP spike >40 mmHg', 'Postoperative IOP', 'incidence of IOP increase ≥10 mmHg relative to baseline on POD1', 'IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1306068', 'cui_str': 'Secondary Cataract'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0229108', 'cui_str': 'Structure of sinus venosus of sclera'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",556.0,0.295207,"The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001).","[{'ForeName': 'Nazlee', 'Initials': 'N', 'LastName': 'Zebardast', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Chengjie', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Jampel', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. Electronic address: hjampel@jhmi.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.025']
265,30013913,Which of the branched-chain amino acids increases cerebral blood flow in hepatic encephalopathy? A double-blind randomized trial.,"Branched-chain amino acids increase the brain perfusion of patients with hepatic encephalopathy (HE), but the amino acid and the mechanisms involved are still unknown. This study compared brain perfusion and clinical improvement during leucine or isoleucine supplementation. After randomization, 27 subjects with cirrhosis and HE received leucine or isoleucine supplements for one year. Brain single Photon Emission Computed Tomography (SPECT) and dynamic brain scintigraphy (DBS) were performed pretreatment and at 1, 8 and 12 months of supplementation. Brain perfusion was increased only in the isoleucine group at 8 months of treatment by both SPECT and DBS ( p  < 0.001 and  p  = 0.05, respectively) and by SPECT at the 12th month ( p  < 0.05). This was associated with hepatic encephalopathy improvement at 8 and 12 months ( p  = 0.008 and 0.004, respectively), which was not observed in the leucine group ( p  = 0.313 and 0.055, respectively). Isoleucine supplementation achieved a better impact on brain perfusion restoration in HE.",2018,"This was associated with hepatic encephalopathy improvement at 8 and 12 months ( p  = 0.008 and 0.004, respectively), which was not observed in the leucine group ( p  = 0.313 and 0.055, respectively).","['27 subjects with cirrhosis and HE received', 'patients with hepatic encephalopathy (HE']","['branched-chain amino acids', 'Branched-chain amino acids', 'Isoleucine supplementation', 'leucine or isoleucine supplements', 'leucine or isoleucine supplementation', 'Brain single Photon Emission Computed Tomography (SPECT) and dynamic brain scintigraphy (DBS']","['brain perfusion', 'hepatic encephalopathy improvement', 'cerebral blood flow', 'Brain perfusion', 'brain perfusion restoration']","[{'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0022192', 'cui_str': 'L-isoleucine'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]",27.0,0.368642,"This was associated with hepatic encephalopathy improvement at 8 and 12 months ( p  = 0.008 and 0.004, respectively), which was not observed in the leucine group ( p  = 0.313 and 0.055, respectively).","[{'ForeName': 'Fernando Gomes', 'Initials': 'FG', 'LastName': 'Romeiro', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: fgromeiro@fmb.unesp.br.'}, {'ForeName': 'Marjorie do Val', 'Initials': 'MDV', 'LastName': 'Ietsugu', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Letícia de Campos', 'Initials': 'LC', 'LastName': 'Franzoni', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Augusti', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Alvarez', 'Affiliation': 'Department of Physics and Biophysics, Botucatu Biosciences Institute, UNESP - Univ Estadual Paulista, Rua Prof. Dr. Antonio Celso Wagner Zanin, s/n, Botucatu, São Paulo 18618-689, Brazil. Electronic address: matheus@consult.med.br.'}, {'ForeName': 'Lívia Alves Amaral', 'Initials': 'LAA', 'LastName': 'Santos', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Talles Bazeia', 'Initials': 'TB', 'LastName': 'Lima', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Kátia Hiromoto', 'Initials': 'KH', 'LastName': 'Koga', 'Affiliation': 'Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n. Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: khkoga@fmb.unesp.br.'}, {'ForeName': 'Sônia Marta', 'Initials': 'SM', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n. Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'Caramori', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: giovanni@fmb.unesp.br.'}, {'ForeName': 'Luiz Eduardo Gomes Garcia', 'Initials': 'LEGG', 'LastName': 'Betting', 'Affiliation': 'Department of Neurology, Psychology and Psychiatry, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: betting@fmb.unesp.br.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.03.028']
266,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
267,32203810,"Metabolic linkages between indoor negative air ions, particulate matter and cardiorespiratory function: A randomized, double-blind crossover study among children.","BACKGROUND


Ionization air purifiers, which purify particulate matter (PM) by producing vast number of negative air ions (NAI), are widely used. Recent study implied that ionization air purification could bring respiratory benefits but deterioration of heart rate variability (HRV). However, its underlying molecular mechanisms remain unclear.
OBJECTIVES


To explore the molecular linkages between indoor NAI, decreased PM and the cardiorespiratory effect after purification.
METHODS


Urine samples were collected from 44 healthy children three times of each study period (real and sham purification) in an existing randomized, double-blind crossover study. Ultra-high performance liquid chromatography/mass spectrometry was conducted in metabolomics analysis, the associations between indoor NAI, decreased PM and the cardiorespiratory function were investigated via the meet-in-metabolite approach (MIMA) based on statistical and metabolic pathway analysis. Mixed-effect models were used to establish associations between exposure, health parameters and metabolites.
RESULTS


Twenty-eight and fourteen metabolites were identified with significant correlations to NAI and PM, respectively. Besides, eight and eighteen metabolites were separately associated with respiratory function and HRV. The increased NAI and decreased PM improved respiratory function mainly with eight pathways, promoting energy production, anti-inflammation and anti-oxidation capacity. Decreased PM ameliorated HRV with six main pathways, increasing energy production and anti-inflammation capacity while increased NAI deteriorated HRV with five main pathways, lowering energy generation and anti-oxidation capacity.
CONCLUSIONS


Increased NAI and decreased PM ameliorated respiratory function by increasing energy production, improving anti-inflammation and anti-oxidation capacity. Decreased PM improved cardiac autonomic function by increasing energy production and anti-inflammation capacity, while these benefits were overcast by massive NAI via lowering energy generation and anti-oxidation capacity with different metabolic pathways.",2020,"Decreased PM ameliorated HRV with six main pathways, increasing energy production and anti-inflammation capacity while increased NAI deteriorated HRV with five main pathways, lowering energy generation and anti-oxidation capacity.
","['Urine samples were collected from 44 healthy children three times of each study period (real and sham purification', 'children']",[],"['energy production and anti-inflammation capacity', 'anti-inflammation and anti-oxidation capacity', 'Decreased PM improved cardiac autonomic function', 'energy production, anti-inflammation and anti-oxidation capacity']","[{'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0243114', 'cui_str': 'purification'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0033268'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",44.0,0.0576249,"Decreased PM ameliorated HRV with six main pathways, increasing energy production and anti-inflammation capacity while increased NAI deteriorated HRV with five main pathways, lowering energy generation and anti-oxidation capacity.
","[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Mengtian', 'Initials': 'M', 'LastName': 'Chu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Heqing', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Furong', 'Initials': 'F', 'LastName': 'Deng', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}]",Environment international,['10.1016/j.envint.2020.105663']
268,32205201,Two-year clinical evaluation of a proanthocyanidins-based primer in non-carious cervical lesions: A double-blind randomized clinical trial.,"OBJECTIVES


This double-blind randomized clinical trial evaluated the influence of pre-treatment with proanthocyanidins (PA) from grape seed extract on the clinical behavior of a simplified etch-and-rinse adhesive placed in non-carious cervical lesions (NCCLs) over 6- and 24-months.
MATERIALS AND METHODS


A total of 135 restorations were randomly inserted in 45 subjects. The NCCLs were etched with 37 % phosphoric acid for 15 s and distributed into 3 groups: Control (PA0) - adhesive ExciTE F applied as per the manufacturer's recommendations; PA2 and PA5 groups - 2 wt% and 5 wt% PA solution, respectively, were applied for 60 s and washed for 30 s prior to application of the adhesive. The resin composite was placed incrementally and light-cured. The restorations were evaluated at baseline, 6 months (6 m) and 24 months (24 m) using both the FDI and USPHS criteria. Statistical analyses were carried out using Friedman repeated-measures analysis of variance by rank and the Wilcoxon test (α = 0.05).
RESULTS


The retention rates were 98 % (PA0), 98 % (PA2) and 83 % (PA5) after 6 m and 93 % (PA0), 89 % (PA2) and 70 % (PA5) after 24 m. Only PA5 resulted in a significant lower retention rate at 6 m and at 24 m compared with that of baseline (p = 0.03). All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared. These differences were considered clinically acceptable under the FDI criteria.
CONCLUSIONS


The application of PA as a primer did not result in clinical advantages after 24 m of clinical service, regardless of the concentration used.
CLINICAL RELEVANCE


It has been reported that PA, a collagen crosslinking agent, increases the durability of the dentin-resin interface. However, no effects were found clinically after 24 months.",2020,All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared.,"['non-carious cervical lesions', 'A total of 135 restorations were randomly inserted in 45\u2009subjects']","['phosphoric acid', 'proanthocyanidins (PA', 'proanthocyanidins-based primer']","['marginal adaptation and marginal staining for the FDI criteria', 'retention rate', 'retention rates']","[{'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}]","[{'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0072018', 'cui_str': 'proanthocyanidin'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",135.0,0.161651,All groups resulted in a significantly worse marginal adaptation and marginal staining for the FDI criteria when the baseline vs. the 24 m recall data were compared.,"[{'ForeName': 'Lidiane Costa', 'Initials': 'LC', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: lidiane.csouza@yahoo.com.br.'}, {'ForeName': 'Nara Sousa', 'Initials': 'NS', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: nara.sousa.rodrigues@gmail.com.'}, {'ForeName': 'Diana Araújo', 'Initials': 'DA', 'LastName': 'Cunha', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: araujo.diana@gmail.com.'}, {'ForeName': 'Victor Pinheiro', 'Initials': 'VP', 'LastName': 'Feitosa', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil; Paulo Picanço School of Dentistry, Fortaleza, Ceará, Brazil. Electronic address: victorpfeitosa@hotmail.com.'}, {'ForeName': 'Sérgio Lima', 'Initials': 'SL', 'LastName': 'Santiago', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: sergiosantiago@yahoo.com.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil. Electronic address: reis_ale@hotmail.com.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'School of Dentistry, Department of Restorative Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil. Electronic address: aloguercio@hotmail.com.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Perdigão', 'Affiliation': 'Department of Restorative Sciences, University of Minnesota, Minneapolis, MN, USA. Electronic address: perdi001@umn.edu.'}, {'ForeName': 'Vicente de Paulo Aragão', 'Initials': 'VPA', 'LastName': 'Saboia', 'Affiliation': 'Postgraduate Program of Dentistry - Faculty of Pharmacy, Dentistry and Nursing, Federal University of Ceará, Fortaleza, Ceará, Brazil. Electronic address: vpsaboia@yahoo.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103325']
269,22374991,"Gastric cancer incidence among Hispanics in California: patterns by time, nativity, and neighborhood characteristics.","BACKGROUND


Better understanding about gastric cancer incidence patterns among Hispanics by birthplace, socioeconomic status (SES), and acculturation can improve preventive strategies and disease models.
METHODS


Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer were calculated by age, sex, and nativity among Hispanics using California Cancer Registry data from 1988 through 2004. Incidence rates in 1998 to 2002 were compared by neighborhood SES and Hispanic enclave status according to 2000 US Census data.
RESULTS


Incidence rates of diffuse gastric cancer increased from 1988 through 2004 among foreign-born Hispanic men (EAPC: 3.5%, 95% CI: 1.5%-5.5%) and U.S.-born Hispanic women (EAPC: 3.0%, 95% CI: 0.7%-5.3%). During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women. Noncardia and both intestinal and diffuse gastric cancer were more common in foreign-born than U.S.-born Hispanic men and women, and in those from lower SES, higher enclave neighborhoods. By contrast, among younger and middle-aged Hispanic men, cardia tumors were more common in the U.S.-born than the foreign-born, and in higher SES, lower enclave neighborhoods.
CONCLUSIONS


Varying gastric cancer risk factors among Hispanic subgroups and increasing rates of diffuse gastric cancer in foreign-born Hispanic men and U.S.-born Hispanic women merit further investigation to identify separate disease etiologies.
IMPACT


Age, sex, birthplace, SES, and acculturation modify gastric cancer incidence in Hispanics and should be considered when examining disease risk and prevention.",2012,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","['foreign-born Hispanic men and U.S.-born Hispanic women', 'younger and middle-aged Hispanic men, cardia tumors', 'Hispanics in California']",[],"['Noncardia and both intestinal and diffuse gastric cancer', 'Incidence rates', 'time, nativity, and neighborhood characteristics', 'cardia and noncardia gastric cancer', 'Incidence rates of diffuse gastric cancer', 'Incidence rates, rate ratios, and estimated annual percent change (EAPC) in rates of anatomic and histologic subtype-specific gastric cancer', 'Gastric cancer incidence', 'incidence rates of intestinal gastric cancer']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0006754', 'cui_str': 'California'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0007144', 'cui_str': 'Cardia'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.019428,"During the same time period, incidence rates of intestinal gastric cancer declined significantly and both cardia and noncardia gastric cancer were steady or declined among foreign-born and U.S.-born Hispanic men and women.","[{'ForeName': 'Ellen T', 'Initials': 'ET', 'LastName': 'Chang', 'Affiliation': 'Cancer Prevention Institute of California, Fremont, CA, USA. echang@exponent.com'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Fish', 'Affiliation': ''}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Schupp', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': ''}, {'ForeName': 'Mindy C', 'Initials': 'MC', 'LastName': 'DeRouen', 'Affiliation': ''}, {'ForeName': 'Theresa H M', 'Initials': 'TH', 'LastName': 'Keegan', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Clarke', 'Affiliation': ''}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Glaser', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-11-1208']
270,31805386,Bony Ingrowth of Coil-Type Open-Architecture Anchors Compared With Screw-Type PEEK Anchors for the Medial Row in Rotator Cuff Repair: A Randomized Controlled Trial.,"PURPOSE


To evaluate outcomes of screw-type and coil-type open-architecture suture anchors with respect to bony ingrowth, release of biological markers, and patient-reported outcome measures when used in rotator cuff repair (RCR).
METHODS


Forty patients undergoing arthroscopic RCR for full-thickness rotator cuff tears were enrolled and prospectively randomized to receive a screw-type (19 patients) or coil-type (21 patients) suture anchor for the medial row during repair. All repairs used a transosseous-equivalent configuration with footprint anchors laterally. Marrow elements released during surgery were evaluated for 9 cytokine markers (insulin-like growth factor 1, fibroblast growth factor 2, bone morphogenetic proteins 7 and 2, platelet-derived growth factors AA and BB, epidermal growth factor, transforming growth factor beta1, and vascular endothelial growth factor). Postoperative computed tomography scans were performed at 6 months. Range of motion, strength, and validated patient-reported outcome measures (Simple Shoulder Test, Single Assessment Numeric Evaluation, visual analog scale, and American Shoulder and Elbow Surgeons scores) were gathered before the operation and at 6 months and 1 year postoperatively.
RESULTS


Bone mineral density surrounding the coil-type anchor was significantly greater than that surrounding the screw-type anchor (P = .005). Bone mineral density values within the coil-type and screw-type anchors were comparable (P = .527); however, a larger amount of total bone mineral mass (in milligrams) was shown within the coil-type anchor owing to its larger volume (P < .01). Marrow elements released at the repair site were similar between groups (P > .05). Postoperatively, no statistically significant difference was found between groups for clinical outcome measures at 6 months or 1 year. Retear and complication rates were similar between groups (P > .05).
CONCLUSIONS


Both the coil-type and screw-type anchors can be reliably used for RCR and produce similar clinical outcomes. The coil-type anchor resulted in superior bony growth surrounding the anchor and a larger total bone mineral mass within the anchor owing to its larger volume.
LEVEL OF EVIDENCE


Level II, randomized prospective comparative study.",2020,Both the coil-type and screw-type anchors can be reliably used for RCR and produce similar clinical outcomes.,"['Rotator Cuff Repair', 'for full-thickness rotator cuff tears', 'Forty patients undergoing']","['Coil-Type Open-Architecture Anchors', 'screw-type (19 patients) or coil-type (21 patients) suture anchor for the medial row during repair', 'screw-type and coil-type open-architecture suture anchors', 'arthroscopic RCR']","['Retear and complication rates', 'total bone mineral mass', 'Range of motion, strength, and validated patient-reported outcome measures (Simple Shoulder Test, Single Assessment Numeric Evaluation, visual analog scale, and American Shoulder and Elbow Surgeons scores', 'Bone mineral density values', 'rotator cuff repair (RCR']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0410017', 'cui_str': 'Complete rupture of rotator cuff'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}]",40.0,0.0819321,Both the coil-type and screw-type anchors can be reliably used for RCR and produce similar clinical outcomes.,"[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Chahla', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Loma Linda University Medical Center, Loma Linda, California, U.S.A.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Manderle', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Beletsky', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Cabarcas', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Anirudh K', 'Initials': 'AK', 'LastName': 'Gowd', 'Affiliation': 'Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, U.S.A.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chubinskaya', 'Affiliation': 'Department of Pediatrics, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Trenhaile', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Forsythe', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cole', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Division of Sports Medicine, Midwest Orthopaedics at Rush, Rush University Medical Center, Chicago, Illinois, U.S.A.. Electronic address: Nikhil.verma@rushortho.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2019.11.119']
271,30982808,"Japan Trial in High-Risk Individuals to Enhance Their Referral to Physicians (J-HARP)-A Nurse-Led, Community-Based Prevention Program of Lifestyle-Related Disease.","BACKGROUND


It is uncertain whether health counselling after community-based health checkups for high-risk individuals of lifestyle-related disease enhances their referral to physicians.
METHODS


We performed a clustered randomized controlled trial of untreated high-risk individuals aged 40 to 74 years who were screened from the annual health checkup in 2014 and 2015 under the national health insurance in 43 municipalities around Japan, assigning 21 intervention and 22 usual care municipalities. The high-risk conditions were severe forms of hypertension, diabetes, dyslipidemia (for men), and proteinuria. For the intervention group, the theory-based health counselling was performed to enhance referrals to physicians, while each municipality performed its own standard counselling for the usual care group. Data on clinical visits and risk factors were collected systematically and anonymously from the databases of health insurance qualification, health insurance claims, and annual health checkups. Hypotheses are that the cumulative proportion of seeing physicians (clinical visits) is higher in the intervention than the usual care groups, and that those in the intervention group have lower cumulative incidence of composite outcomes associated with lifestyle-related diseases.
RESULTS


The numbers of subjects for the analyses were 8,977 in the intervention group and 6,733 in the usual care group. Among them, 6,758 had hypertension, 2,147 had diabetes, 2,861 had dyslipidemia, and 1,221 had proteinuria in the intervention group, with corresponding numbers of 4,833, 1,517, 2,262, and 845, respectively, in the usual care group. There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups.
CONCLUSIONS


We expect to provide scientific evidence on the effectiveness of health counselling.",2020,"There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups.
","['untreated high-risk individuals aged 40 to 74 years, screened from the annual health checkup in 2014 and 2015 under the national health insurance in 43 municipalities around Japan, assigning 21 intervention and 22 usual care municipalities', '6,758 had hypertension, 2,147 diabetes, 2,861 dyslipidemia, and 1,221 proteinuria in the intervention group, and 4,833, 1,517, 2,262 and 845 in the usual care group', 'High-risk Individuals to Accelerate their Referral to Physicians (J-HARP) - a Nurse-led, Community-based Prevention Program of Lifestyle-related Disease']",[],['mean levels and proportions of major cardiovascular risk factors'],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0600182'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0084084', 'cui_str': 'pleiotropin'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0487147,"There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups.
","[{'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Sumi', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Sairenchi', 'Affiliation': 'Department of Public Health, Dokkyo Medical University School of Medicine.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Kinuta', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Miyae', 'Initials': 'M', 'LastName': 'Yamakawa', 'Affiliation': 'Department of Health Sciences, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Takahara', 'Affiliation': 'Department of Metabolic Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Imano', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Kitamura', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'School of Nursing, Miyagi University.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Graduate School of Medicine Osaka City University.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Saito', 'Affiliation': 'Department of Community Health Systems Nursing, Ehime University Graduate School of Medicine.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'National Institute of Public Health.'}, {'ForeName': 'Iichiro', 'Initials': 'I', 'LastName': 'Shimomura', 'Affiliation': 'Department of Health Sciences, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Iso', 'Affiliation': 'Public Health, Department of Social Medicine, Graduate School of Medicine Osaka University.'}]",Journal of epidemiology,['10.2188/jea.JE20180194']
272,31272265,"A prospective, randomized clinical trial of transverse versus longitudinal incisions for trigger finger release.","We investigated whether incision type affects scar quality or outcome following trigger finger release. Our primary and secondary hypotheses were that transverse and longitudinal incision types yield similar scar quality and functional improvement. Digits undergoing trigger finger release at the participating hospitals were randomized to receive transverse or longitudinal incisions. The Patient Scar Assessment Scale, Observer Scar Assessment Scale, and the Disabilities of the Arm, Shoulder and Hand score were collected at 8 and 54 weeks postoperatively. Of 86 randomized patients, 67 patients (71%) had followed-up at 54 weeks postoperatively. We found no significant differences in above three assessments between the incisions at either time-point. Among patients receiving both incision types for multiple simultaneous trigger finger release, there were no significant differences in Patient Scar Assessment Scale or Observer Scar Assessment Scale scores. We found no significant difference in the scar quality and improvement in patient-reported disability with transverse or longitudinal incisions for trigger finger release.  Level of evidence:  II.",2019,We found no significant difference in the scar quality and improvement in patient-reported disability with transverse or longitudinal incisions for trigger finger release.  ,"['Digits undergoing trigger finger release at the participating hospitals', '86 randomized patients, 67 patients (71%) had followed-up at 54\xa0weeks postoperatively']",[],"['scar quality', 'scar quality and functional improvement', 'Patient Scar Assessment Scale or Observer Scar Assessment Scale scores', 'Patient Scar Assessment Scale, Observer Scar Assessment Scale, and the Disabilities of the Arm, Shoulder and Hand score']","[{'cui': 'C0407128', 'cui_str': 'Release of trigger finger (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",86.0,0.0235077,We found no significant difference in the scar quality and improvement in patient-reported disability with transverse or longitudinal incisions for trigger finger release.  ,"[{'ForeName': 'Nikolas H', 'Initials': 'NH', 'LastName': 'Kazmers', 'Affiliation': 'Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holt', 'Affiliation': 'OrthoTennessee, Knoxville Orthopaedic Clinic, Knoxville, TN, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Tyser', 'Affiliation': 'Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419859375']
273,31096828,Syndactyly release: a comparison of skin graft versus graftless techniques in the same patient.,"Syndactyly release may be done by skin graft or graftless techniques. We prospectively examined bilateral syndactyly releases in the same patient at one operation. The grafted side was randomized and the contralateral side was done graftless. Fourteen patients had surgery at a mean age of 27 months (range 7-166). The mean follow-up was 52 months (range 6-111). The mean tourniquet time was 97 minutes (range 66-135) for graft and 84 minutes (55-120) for graftless. The mean finger abduction was 57° (32°-80°) for graft and 54° (38°-80°) for graftless. The mean web creep score was 1.2 (0-3) for graft and 2.1 (0-3) for graftless. The mean scar score was 1.9 (1-3) bilaterally. The mean parents' visual analogue scale for graft cosmesis was 7.1 (5-9) and 6.2 (4.3-8) for graftless. The surgeon's visual analogue scale for graft was 7.9 (6.4-9.5) and 6.2 (4-8.7) for graftless. The therapist's visual analogue scale was 7.9 (6.5-10) and 6.4 (4.7-8) for graftless. Although there is a longer tourniquet time with grafting, there may be advantages in appearance and web creep.  Level of evidence:  II.",2019,The surgeon's visual analogue scale for graft was 7.9 (6.4-9.5) and 6.2 (4-8.7) for graftless.,"['38°-80', '°) for graft and 54° ', 'Fourteen patients had surgery at a mean age of 27 months (range 7-166']",['skin graft versus graftless techniques'],"['mean scar score', 'mean finger abduction', ""mean parents' visual analogue scale for graft cosmesis"", 'mean tourniquet time', ""therapist's visual analogue scale"", ""surgeon's visual analogue scale for graft"", 'mean web creep score']","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0037297', 'cui_str': 'Grafting, Skin'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}]",,0.0321173,The surgeon's visual analogue scale for graft was 7.9 (6.4-9.5) and 6.2 (4-8.7) for graftless.,"[{'ForeName': 'Angela A', 'Initials': 'AA', 'LastName': 'Wang', 'Affiliation': 'Orthopedics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Hutchinson', 'Affiliation': 'Orthopedics, University of Utah, Salt Lake City, UT, USA.'}]","The Journal of hand surgery, European volume",['10.1177/1753193419848989']
274,31334795,Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial.,"Importance


Hyperglycemia during acute ischemic stroke is common and is associated with worse outcomes. The efficacy of intensive treatment of hyperglycemia in this setting remains unknown.
Objectives


To determine the efficacy of intensive treatment of hyperglycemia during acute ischemic stroke.
Design, Setting, and Participants


The Stroke Hyperglycemia Insulin Network Effort (SHINE) randomized clinical trial included adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or ≥150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018. The trial included 1151 patients who met eligibility criteria.
Interventions


Patients were randomized to receive continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n = 581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n = 570) for up to 72 hours.
Main Outcomes and Measures


The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0 [no symptoms or completely recovered] to 6 [death]) that was adjusted for baseline stroke severity.
Results


Among 1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 529 [46%] women, 920 [80%] with diabetes), 1118 (97%) completed the trial. Enrollment was stopped for futility based on prespecified interim analysis criteria. During treatment, the mean blood glucose level was 118 mg/dL (6.6 mmol/L) in the intensive treatment group and 179 mg/dL (9.9 mmol/L) in the standard treatment group. A favorable outcome occurred in 119 of 581 patients (20.5%) in the intensive treatment group and in 123 of 570 patients (21.6%) in the standard treatment group (adjusted relative risk, 0.97 [95% CI, 0.87 to 1.08], P = .55; unadjusted risk difference, -0.83% [95% CI, -5.72% to 4.06%]). Treatment was stopped early for hypoglycemia or other adverse events in 65 of 581 patients (11.2%) in the intensive treatment group and in 18 of 570 patients (3.2%) in the standard treatment group. Severe hypoglycemia occurred only among patients in the intensive treatment group (15/581 [2.6%]; risk difference, 2.58% [95% CI, 1.29% to 3.87%]).
Conclusions and Relevance


Among patients with acute ischemic stroke and hyperglycemia, treatment with intensive vs standard glucose control for up to 72 hours did not result in a significant difference in favorable functional outcome at 90 days. These findings do not support using intensive glucose control in this setting.
Trial Registration


ClinicalTrials.gov Identifier: NCT01369069.",2019,The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0,"['1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 529 [46%] women, 920 [80%] with diabetes), 1118 (97%) completed the trial', 'patients with acute ischemic stroke and hyperglycemia', 'Patients With Acute Ischemic Stroke', '1151 patients who met eligibility criteria', 'adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or ≥150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018']",['continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n\u2009=\u2009581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n\u2009=\u2009570) for up to 72 hours'],"['mean blood glucose level', 'Severe hypoglycemia', '90-day modified Rankin Scale score (a global stroke disability scale', 'hypoglycemia or other adverse events', 'favorable functional outcome', 'no symptoms or completely recovered] to 6 [death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0240016', 'cui_str': 'Insulin used (attribute)'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1151.0,0.1673,The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0,"[{'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnston', 'Affiliation': 'Department of Neurology, University of Virginia, Charlottesville.'}, {'ForeName': 'Askiel', 'Initials': 'A', 'LastName': 'Bruno', 'Affiliation': 'Department of Neurology, Medical College of Georgia, Augusta University, Augusta.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pauls', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Christiana E', 'Initials': 'CE', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, Mayo Clinic Florida, Jacksonville.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fansler', 'Affiliation': 'Brain Institute, University of Virginia, Charlottesville.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Van de Bruinhorst', 'Affiliation': 'Department of Neurology and Neurotherapeutics, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Durkalski-Mauldin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.9346']
275,32228235,"A comparative, single-blind, randomized study on quetiapine and aripiperazole augmentation in treatment of selective serotonin reuptake inhibitor refractory obsessive-compulsive disorder.","Obsessive-compulsive disorder (OCD) is a chronic psychiatric disorder, of unknown etiology, that affects 2.5% of the population. An appropriate therapeutic response to conventional treatment is seen. Some studies use augmentative treatment by antipsychotics, glutamatergic, lithium, buspirone, and others agents to improve the therapeutic response. In this study, we aimed to evaluate the efficacy and tolerability of aripiprazole and quetiapine as augmentative treatments in patients with selective serotonin reuptake inhibitor (SSRI) refractory OCD. The OCD patients were initially treated for 12 weeks with a SSRI. If after 12 weeks their Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score was more than 16, they were randomly assigned to either the aripiprazole or the quetiapine augmentation group for an additional 12 weeks. There were no significant differences in age, sex, education, marital status, or score of Y-BOCS and Clinical Global Impression-Severity Scale (CGI-S) between groups ( p  > 0.05) at the outset of the study. Significant differences were noted after 1 month when compared with results at 2, 3, and 4 months in both groups ( p  < 0.001). Both quetiapine and aripiprazole may be effective and well-tolerated augmentative agents in the treatment of SSRI-refractory OCD. Because of positive results, aripiprazole may be considered more effective and may have a more rapid onset in terms of therapeutic response.",2020,"There were no significant differences in age, sex, education, marital status, or score of Y-BOCS and Clinical Global Impression-Severity Scale (CGI-S) between groups ( p  > 0.05) at the outset of the study.","['selective serotonin reuptake inhibitor refractory obsessive-compulsive disorder', 'patients with selective serotonin reuptake inhibitor (SSRI) refractory OCD']","['quetiapine and aripiperazole augmentation', 'aripiprazole and quetiapine', 'quetiapine augmentation', 'quetiapine', 'aripiprazole']","['Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score', 'Obsessive-compulsive disorder (OCD', 'efficacy and tolerability', 'age, sex, education, marital status, or score of Y-BOCS and Clinical Global Impression-Severity Scale (CGI-S']","[{'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0187248,"There were no significant differences in age, sex, education, marital status, or score of Y-BOCS and Clinical Global Impression-Severity Scale (CGI-S) between groups ( p  > 0.05) at the outset of the study.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Talaei', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center and Department of Psychiatry, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Farhad Farid', 'Initials': 'FF', 'LastName': 'Hosseini', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center and Department of Psychiatry, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aghili', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Asadpour', 'Affiliation': 'Anesthesiology and Critical Care Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Neema John', 'Initials': 'NJ', 'LastName': 'Mehramiz', 'Affiliation': 'The University of Arizona, College of Medicine, Tucson, AZ 85724, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Forouzanfar', 'Affiliation': 'Neuroscience Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Canadian journal of physiology and pharmacology,['10.1139/cjpp-2019-0381']
276,31974063,Effect of a Simple Exercise Program on Hospitalization-Associated Disability in Older Patients: A Randomized Controlled Trial.,"OBJECTIVE


Hospitalization-associated disability [HAD, ie, the loss of ability to perform ≥1 basic activities of daily living (ADLs) independently at discharge] is a frequent condition among older patients. The present study assessed whether a simple inpatient exercise program decreases HAD incidence in acutely hospitalized very old patients.
DESIGN


In this randomized controlled trial (Activity in Geriatric Acute Care) participants were assigned to a control or intervention group and were assessed at baseline, admission, discharge, and 3 months thereafter.
SETTING AND PARTICIPANTS


In total, 268 patients (mean age 88 years, range 75-102) admitted to an acute care for older patients unit of a public hospital were randomized to a control (n = 125) or intervention (exercise) group (n = 143).
METHODS


Both groups received usual care, and patients in the intervention group also performed simple supervised exercises (walking and rising from a chair, for a total duration of ∼20 minutes/day). We measured ADL function (Katz index) and incident HAD at discharge and after 3 months (primary outcome) and Short Physical Performance Battery, ambulatory capacity, number of falls, rehospitalization, and death during a 3-month follow-up (secondary outcomes).
RESULTS


Median duration of hospitalization was 7 days (interquartile range 4 days). The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17-0.76, P = .007] and admission (OR 0.29; 95% CI 0.10-0.89, P = .030). A trend toward an improved ADL function at discharge vs admission was found in the intervention group compared with controls (OR 0.32; 95% CI ‒0.04 to 0.68; P = .083). No between-group differences were noted for the other endpoints (all P > .05).
CONCLUSION AND IMPLICATIONS


A simple inpatient exercise program decreases risk of HAD in acutely hospitalized, very old patients.",2020,"The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17-0.76, P = .007] and admission (OR 0.29; 95% CI 0.10-0.89, P = .030).","['acutely hospitalized, very old patients', 'Geriatric Acute Care) participants', 'older patients', 'acutely hospitalized very old patients', 'Older Patients', '268 patients (mean age 88\xa0years, range 75-102) admitted to an acute care for older patients\xa0unit of a public hospital']","['control (n\xa0=\xa0125) or intervention (exercise', 'inpatient exercise program', 'Simple Exercise Program', 'simple inpatient exercise program', 'usual care, and patients in the intervention group also performed simple supervised exercises (walking and rising from a chair']","['Median duration of hospitalization', 'Hospitalization-Associated Disability', 'ADL function', 'ADL function (Katz index) and incident HAD at discharge and after 3\xa0months (primary outcome) and Short Physical Performance Battery, ambulatory capacity, number of falls, rehospitalization, and death during a 3-month follow-up (secondary outcomes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living (assessment scale)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",268.0,0.146437,"The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17-0.76, P = .007] and admission (OR 0.29; 95% CI 0.10-0.89, P = .030).","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ortiz-Alonso', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain. Electronic address: javier.ortiz@salud.madrid.org.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bustamante-Ara', 'Affiliation': 'Universidad Autónoma de Chile, Talca, Chile.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Systems Biology Department, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Vidán-Astiz', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rodríguez-Romo', 'Affiliation': 'Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; Sports Department, Instituto Nacional de Educación Física, Universidad Politécnica, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mayordomo-Cava', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Javier-González', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Hidalgo-Gamarra', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Myriel', 'Initials': 'M', 'LastName': 'Lopéz-Tatis', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Valades-Malagón', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Santos-Lozano', 'Affiliation': ""i+HeALTH, European University Miguel de Cervantes, Valladolid, Spain; Research Institute Hospital 12 de Octubre ('i+12'), Madrid, Spain.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': ""Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; Research Institute Hospital 12 de Octubre ('i+12'), Madrid, Spain; Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.""}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Serra-Rexach', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; School of Medicine, Universidad Complutense, Madrid, Spain.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.11.027']
277,31917762,"Dose Finding Study of Gadopiclenol, a New Macrocyclic Contrast Agent, in MRI of Central Nervous System.","OBJECTIVES


The aim of this study was to determine a safe and effective dose of gadopiclenol, a new high relaxivity macrocyclic gadolinium-based contrast agent. Based on the contrast-to-noise ratio (CNR) as primary criterion, this new agent was compared with gadobenate dimeglumine in patients with contrast-enhancing central nervous system lesions.
METHODS AND MATERIALS


This phase IIb international, multicenter, double-blind, randomized, controlled, parallel dose groups, and cross-over study included adult patients with known or highly suspected lesions with disrupted blood-brain barrier. Patients were randomized to 1 of 4 doses of gadopiclenol (0.025, 0.05, 0.1, 0.2 mmol/kg) and to 1 series of 2 magnetic resonance imaging scans: gadopiclenol then gadobenate dimeglumine at 0.1 mmol/kg or vice versa. The qualitative and quantitative efficacy evaluations were performed by 3 independent off-site blinded readers. Adverse events were monitored up to 1 day after second magnetic resonance imaging.
RESULTS


The study population included 272 patients (58.5% females) with a mean (SD) age of 53.8 (13.6) years. The superiority of gadopiclenol over gadobenate dimeglumine was statistically demonstrated at 0.2 and 0.1 mmol/kg for all readers with an increase in CNR of more than 30% (P ≤ 0.0007). At 0.05 mmol/kg, gadopiclenol showed a CNR of similar magnitude as gadobenate dimeglumine at 0.1 mmol/kg, with no statistically significant difference. Similar results were obtained for lesion-to-brain ratio and contrast enhancement percentage, as secondary criteria. The relationship between CNR and dose of gadopiclenol was linear for all readers. Mean scores for lesion visualization variables, particularly lesion contrast enhancement, tended to be higher with gadopiclenol at 0.1 and 0.2 mmol/kg compared with gadobenate dimeglumine. All 3 readers mainly expressed an overall diagnostic preference for images with gadopiclenol at 0.1 mmol/kg (45.3%, 50.9%, or 86.8% of images) or expressed no preference (49.1%, 49.1%, or 9.4%, respectively), whereas preference for images with gadobenate dimeglumine was reported by 2 readers for 3.8% and 5.7% of the images. Predominantly, no preference was expressed when comparing images with gadopiclenol at 0.05 mmol/kg to those with gadobenate dimeglumine.Rates of adverse reactions were comparable for gadopiclenol (11.7%) and gadobenate dimeglumine (12.1%). Changes from baseline of more than 25% in serum creatinine and estimated glomerular filtration rate occurred in less than 2% of patients equally for gadopiclenol and gadobenate dimeglumine. Changes from baseline for the values of blood urea nitrogen and cystatin C were also similar between gadopiclenol and gadobenate dimeglumine. No safety concerns were detected on centralized electrocardiography readings.
CONCLUSIONS


Between the doses of 0.025 and 0.2 mmol/kg of gadopiclenol, the increase in CNR is linear. Compared with gadobenate dimeglumine at 0.1 mmol/kg, the doses of 0.05 and 0.1 mmol/kg of gadopiclenol gave similar or significantly greater contrast enhancement, respectively, and thus both doses can be considered for future phase III studies.",2020,Changes from baseline for the values of blood urea nitrogen and cystatin C were also similar between gadopiclenol and gadobenate dimeglumine.,"['272 patients (58.5% females) with a mean (SD) age of 53.8 (13.6) years', 'adult patients with known or highly suspected lesions with disrupted blood-brain barrier', 'patients with contrast-enhancing central nervous system lesions']","['gadopiclenol', 'gadopiclenol over gadobenate dimeglumine', 'Gadopiclenol', 'gadobenate dimeglumine']","['Rates of adverse reactions', 'blood urea nitrogen and cystatin C', 'CNR', 'overall diagnostic preference', 'glomerular filtration rate', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0005854', 'cui_str': 'Hemato-Encephalic Barrier'}, {'cui': 'C0742468', 'cui_str': 'Central nervous system lesion'}]","[{'cui': 'C0209453', 'cui_str': 'Gadobenate dimeglumine'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",272.0,0.0616831,Changes from baseline for the values of blood urea nitrogen and cystatin C were also similar between gadopiclenol and gadobenate dimeglumine.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'From the Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': 'Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Balint', 'Initials': 'B', 'LastName': 'Kolumban', 'Affiliation': 'Department of Neurosurgery, University of Pécs, Pécs, Hungary.'}, {'ForeName': 'José Alfonso', 'Initials': 'JA', 'LastName': 'Meza', 'Affiliation': 'Instituto de Neurociencias y Clínica de Epilepsia, Monterrey, Mexico.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'San-Juan', 'Affiliation': 'Clinical Research Department, National Institute of Neurology and Neurosurgery, Clinical Research Institute S.C., Mexico City, Mexico.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Liu', 'Affiliation': 'Departments of Radiology and Radiation Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Anzalone', 'Affiliation': 'Neuroradiology Department, Vita-Salute San Raffaele University, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maravilla', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, WA.'}]",Investigative radiology,['10.1097/RLI.0000000000000624']
278,32243248,The Effect of a Charcoal-based Powder for Enamel Dental Bleaching.,"CLINICAL RELEVANCE


Charcoal based-powders are not effective for dental bleaching.
SUMMARY


Charcoal-based dentifrices for dental whitening are a novelty in the market. Manufacturers claim that such charcoal-based products have whitening, remineralization, antimicrobial, and antifungal properties of charcoal in such products. However, there is no substantial scientific evidence for these claims. This laboratory randomized study was designed to evaluate the whitening properties of a charcoal-based toothpowder. A total of 45 bovine dental enamel discs were randomly distributed into three groups (n=15): group 1, mechanical brushing with a 1450-ppm F toothpaste (control group); group 2, mechanical brushing with an activated charcoal-based powder; group 3, bleaching per the standard protocol using 10% carbamide peroxide. The surface roughness and color of each specimen were analyzed at baseline and after 14 days of experiment. The surface of one randomly selected specimen from each group was examined using a scanning electron microscope (SEM). The Kruskal-Wallis test was used to compare groups at a significance level of 5%. Only group 3 promoted a statistically significant effect on ΔE compared with groups 1 and 2 (p<0.001 and p=0.003, respectively). No statistically significant difference was found between groups for surface roughness (p>0.05). SEM revealed a more irregular surface in group 1 specimens compared with group 2 and 3 specimens. The charcoal-based powder did not seem to have any bleaching effect.",2020,"Only group 3 promoted a statistically significant effect on ΔE compared with groups 1 and 2 ( p <0.001 and  p =0.003, respectively).",['A total of 45 bovine dental enamel discs'],"['Charcoal-based Powder', 'Charcoal-based dentifrices', 'mechanical brushing with a 1450-ppm F toothpaste (control group); group 2, mechanical brushing with an activated charcoal-based powder; group 3, bleaching per the standard protocol using 10% carbamide peroxide', 'charcoal-based toothpowder']","['surface roughness', 'surface roughness and color of each specimen']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]","[{'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0001275', 'cui_str': 'Activated Charcoal'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",45.0,0.0211166,"Only group 3 promoted a statistically significant effect on ΔE compared with groups 1 and 2 ( p <0.001 and  p =0.003, respectively).","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Franco', 'Affiliation': ''}, {'ForeName': 'Jls', 'Initials': 'J', 'LastName': 'Uehara', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Meroni', 'Affiliation': ''}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Zuttion', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-122-L']
279,31822848,Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial.,"PURPOSE


To evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone.
METHODS


A randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session.
RESULTS


Participants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (-2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001) CONCLUSIONS: The Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.",2020,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","['Participants (n\u2009=\u2009133) were predominantly White/European (74%), female (90%), and ≥50 years old (60']","['Genomics ADvISER (www.genomicsadviser.com) decision aid (DA', 'DA followed by discussion with a genetic counselor, or to genetic counseling alone', 'genetic counseling alone']","['knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session', 'counseling time and improved knowledge', 'knowledge of sequencing limitations', 'knowledge of SF', 'shorter counseling time', 'anxiety', 'Decisional conflict', 'decisional conflict']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",133.0,0.134204,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Theresa H M', 'Initials': 'THM', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Muir', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Baxter', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Adena', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Offit', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jada G', 'Initials': 'JG', 'LastName': 'Hamilton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'Department of Molecular Oncology and Hereditary Cancer Program, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0702-z']
280,31812334,Reducing Hospital Readmissions Through a Skilled Nursing Facility Discharge Intervention: A Pragmatic Trial.,"OBJECTIVE


To determine if implementation of Project Re-Engineered Discharge (RED), designed for hospitals but adapted for skilled nursing facilities (SNFs), reduces hospital readmissions after SNF discharge to the community in residents admitted to the SNF following an index hospitalization.
DESIGN


A pragmatic trial.
SETTING AND PARTICIPANTS


SNFs in southeastern Massachusetts, and residents discharged to the community.
METHODS


We compared SNFs that deployed an adapted RED intervention to a matched control group from the same region. The primary outcome was hospital readmission within 30 days after SNF discharge, among residents who had been admitted to the SNF following an index hospitalization and then discharged home. January 2016 through March 2017 was the baseline period; April 2017 through June 2018 was the follow-up period (after implementation of the intervention). We used a difference-in-differences analysis to compare the intervention SNFs to the control group, using generalized estimating equation regression and controlling for facility characteristics.
RESULTS


After implementation of RED, readmission rates were lower across all 4 measures in the intervention group; control facilities' readmission rates remained stable or increased. The relative decrease was 0.9% for the primary outcome of hospital readmission within 30 days after SNF discharge and 1.7% for readmission within 30 days of the index hospitalization discharge date (P ≤ .001 for both comparisons).
CONCLUSIONS AND IMPLICATIONS


We found that a systematic discharge process developed for the hospital can be adapted to the SNF environment and can reduce readmissions back to the hospital, perhaps through improved self-management skills and better engagement with community services. This work is particularly timely because of Medicare's new Value-Based Purchasing Program, in which nursing homes can receive incentive payments if their hospital readmission rates are low relative to their peers. To verify its scalability and broad potential, RED should be validated across a broader diversity of SNFs nationally.",2020,"After implementation of RED, readmission rates were lower across all 4 measures in the intervention group; control facilities' readmission rates remained stable or increased.","['hospitals but adapted for skilled nursing facilities (SNFs), reduces hospital readmissions after SNF discharge to the community in residents admitted to the SNF following an index hospitalization', 'SNFs in southeastern Massachusetts, and residents discharged to the community']",['Project Re-Engineered Discharge (RED'],"[""control facilities' readmission rates"", 'hospital readmission within 30\xa0days after SNF discharge', 'hospital readmission', 'index hospitalization discharge date', 'RED, readmission rates', 'Hospital Readmissions']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037265', 'cui_str': 'Skilled nursing facility'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2361123', 'cui_str': 'Date of discharge'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]",,0.0904642,"After implementation of RED, readmission rates were lower across all 4 measures in the intervention group; control facilities' readmission rates remained stable or increased.","[{'ForeName': 'Rebekah L', 'Initials': 'RL', 'LastName': 'Gardner', 'Affiliation': 'Healthcentric Advisors, Providence, RI; Department of Medicine, Alpert Medical School of Brown University, Providence, RI. Electronic address: rgardner@healthcentricadvisors.org.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Pelland', 'Affiliation': 'Healthcentric Advisors, Providence, RI.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Youssef', 'Affiliation': 'Healthcentric Advisors, Providence, RI.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Morphis', 'Affiliation': 'Healthcentric Advisors, Providence, RI.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Calandra', 'Affiliation': 'Healthcentric Advisors, Providence, RI.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hollands', 'Affiliation': 'Healthcentric Advisors, Providence, RI.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Gravenstein', 'Affiliation': 'Healthcentric Advisors, Providence, RI; Department of Medicine, Alpert Medical School of Brown University, Providence, RI; Department of Health Services Policy and Practice and the Gerontology Center for Healthcare Research, Brown University School of Public Health, Providence, RI; Providence Veterans Administration Medical Center, Providence, RI.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.10.001']
281,32229495,"Evaluation of the Effect of Contezolid (MRX-I) on the Corrected QT Interval in a Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study in Healthy Chinese Volunteers.","Contezolid (MRX-I), a new oxazolidinone, is an antibiotic in development for treating complicated skin and soft tissue infections caused by resistant Gram-positive bacteria. This was a thorough QT study conducted in 52 healthy subjects who were administered oral contezolid at a therapeutic (800 mg) dose, a supratherapeutic (1,600 mg) dose, placebo, and oral moxifloxacin at 400 mg in four separate treatment periods. The pharmacokinetic profile of contezolid was also evaluated. Time point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point. The upper bound of the 90% CI for ΔΔQTc was slightly more than 10 ms with the contezolid supratherapeutic dose at 3 and 4 h postdose, and the prolongation effect on the QT/QTc interval was less than that of the positive control, moxifloxacin, at 400 mg. At 3 and 4 h after the moxifloxacin dose, the moxifloxacin group met the assay sensitivity criteria outlined in ICH Guidance E14 by having a lower confidence bound of ≥5 ms. The results of a linear exposure-response model which were similar to that of a time point analysis demonstrated a slightly positive relationship between contezolid plasma levels and ΔQTcF interval with a slope of 0.227 ms per mg/liter (90% CI, 0.188 to 0.266). In summary, contezolid did not prolong the QT interval at a therapeutic dose and may have a slight effect on QT interval prolongation at a supratherapeutic dose.",2020,Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point.,"['52 healthy subjects who were administered', 'healthy Chinese volunteers']","['placebo', 'placebo, and oral moxifloxacin', 'moxifloxacin', 'oral contezolid', 'supratherapeutic', 'contezolid (MRX-I']","['QT interval prolongation', 'contezolid plasma levels and ΔQTcF interval', 'QT interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",52.0,0.16154,Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (ΔΔQTc) were <10 ms for the contezolid therapeutic dose at each time point.,"[{'ForeName': 'Junzhen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Cao', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Hailan', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuancheng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Beining', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and Family Planning Commission, Shanghai, China.'}, {'ForeName': 'Kanhong', 'Initials': 'K', 'LastName': 'Ni', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jufang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China zhangj_fudan@aliyun.com xiyuewen@medmail.com.cn.'}, {'ForeName': 'Yuewen', 'Initials': 'Y', 'LastName': 'Xi', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China zhangj_fudan@aliyun.com xiyuewen@medmail.com.cn.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02158-19']
282,31950267,Differential effects of sevoflurane and propofol on an electroretinogram and visual evoked potentials.,"The purpose of this study was to simultaneously evaluate the effects of sevoflurane and propofol on an electroretinogram (ERG) and visual evoked potentials (VEPs). Twenty-four patients scheduled for elective surgery under general anesthesia were allocated randomly to receive either sevoflurane (group S) or propofol (group P). An ERG and VEPs were recorded in an awake state and during anesthesia with three different minimum alveolar concentrations (MAC; 0.5, 1.0, and 1.5) of sevoflurane in group S or with three different effect-site concentrations (Ce) of 2, 3, and 4 μg/ml by using a target-controlled infusion technique in group P. Sevoflurane and propofol had little effect on amplitudes of the ERG b-wave. Sevoflurane significantly attenuated the amplitudes of VEP N75-P100 at 0.5, 1.0, and 1.5 MAC. Propofol did not significantly decrease the amplitude of VEPs at Ce of 2 or 3 μg/ml but significantly decreased it at Ce of 4 μg/ml. In summary, propofol and sevoflurane at clinical concentrations had little effect on the amplitude of an ERG. Sevoflurane attenuated the amplitudes of VEPs even at low concentrations. Propofol also attenuated the amplitudes of VEPs to a lesser extent compared to sevoflurane.",2020,"Sevoflurane significantly attenuated the amplitudes of VEP N75-P100 at 0.5, 1.0, and 1.5 MAC.",['Twenty-four patients scheduled for elective surgery under general anesthesia'],"['sevoflurane and propofol', 'Sevoflurane and propofol', 'Sevoflurane', 'propofol and sevoflurane', 'propofol', 'sevoflurane', 'Propofol']","['amplitude of an ERG', 'amplitudes of VEPs', 'amplitudes of VEP N75-P100', 'electroretinogram (ERG) and visual evoked potentials (VEPs', 'amplitude of VEPs', 'electroretinogram and visual evoked potentials']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0546834', 'cui_str': 'Visual evoked potential study'}]",24.0,0.0404969,"Sevoflurane significantly attenuated the amplitudes of VEP N75-P100 at 0.5, 1.0, and 1.5 MAC.","[{'ForeName': 'Ryusuke', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan. s_tanaka@shinshu-u.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ichino', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ishida', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fuseya', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}, {'ForeName': 'Mikito', 'Initials': 'M', 'LastName': 'Kawamata', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, 3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02733-7']
283,32232659,Continuous quadratus lumborum block and femoral nerve block for total hip arthroplasty: a randomized study.,"BACKGROUND


Continuous femoral nerve block (FNB) has been effectively used after total hip arthroplasty (THA). Recently the anterior approach to quadratus lumborum block (QLB) has been shown to produce postoperative pain relief after THA. Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB. In this randomized controlled study, we compared analgesic effects of the two techniques in patients undergoing THA.
METHODS


Thirty patients undergoing THA were randomly allocated into two groups receiving continuous QLB and FNB. Under ultrasound guidance, QLB and FNB were conducted before general anesthesia using 0.25% levobupivacaine 30 ml and 0.5% levobupivacaine 15 ml, respectively, and a catheter was introduced. Postoperatively, all patients received continuous infusion of 0.125% levobupivacaine at 4 ml/h. Postoperative measurements included visual analog scale (VAS) pain scores at rest and on movement, postoperative analgesic demands, cutaneous sensory blockade and adverse events for 48 h.
RESULTS


Six patients were excluded and 24 patients (13 and 11 patients in QLB group and FNB, respectively) were analyzed. VAS scores on movement at 6 h [median (IQR): 67 (41-80) and 38 (22-41) in QLB and FNB groups, respectively, p = 0.008] and 24 h [60 (40-80) and 39 (28-64) in QLB and FNB groups, respectively, p = 0.018] were lower with FNB than with QLB. QLB did not produce consistent cutaneous sensory blockade.
CONCLUSIONS


Analgesic effects of continuous QLB were inferior to those of continuous FNB in patients undergoing THA under the current study condition.",2020,Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB.,"['Thirty patients undergoing THA', 'total hip arthroplasty', 'patients undergoing THA', 'patients undergoing THA under the current study condition']","['continuous infusion of 0.125% levobupivacaine', 'Continuous quadratus lumborum block and femoral nerve block', 'Continuous femoral nerve block (FNB', 'QLB', 'continuous QLB and FNB', 'levobupivacaine 30\xa0ml and 0.5% levobupivacaine']","['visual analog scale (VAS) pain scores at rest and on movement, postoperative analgesic demands, cutaneous sensory blockade and adverse events for 48\xa0h', 'VAS scores on movement at 6\xa0h [median (IQR']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",30.0,0.123723,Continuous QLB would benefit from a catheter insertion site that is farther away from the surgical site compared with continuous FNB.,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Aoyama', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan. ssakura@med.shimane-u.ac.jp.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Tadenuma', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02769-9']
284,32229194,"Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Myomectomy is associated with a significant risk of hemorrhage. Tranexamic acid is a synthetic lysine derivative with antifibrinolytic activity used in other surgical disciplines to reduce blood loss during surgery. However, its utility in gynecologic surgery is not well understood.
OBJECTIVE


This study aimed to determine the effect of early administration of intravenous tranexamic acid on perioperative bleeding and blood transfusion requirements in women undergoing myomectomy.
STUDY DESIGN


This study was a double-blinded, randomized, placebo-controlled trial conducted in an academic teaching hospital. Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss who met the following criteria were included in the study: (1) at least 1 fibroid ≥10 cm, (2) any intramural or broad ligament fibroid ≥6 cm, and/or (3) at least 5 total fibroids based on preoperative imaging. Patients were randomized to receive a single intravenous bolus injection of tranexamic acid 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes before the initial surgical incision. Perioperative bleeding was defined by measuring intraoperative estimated blood loss, change between pre- and postoperative hemoglobin, and frequency of blood transfusions. Estimated blood loss was calculated by combining the blood volume collected within the suction canister and the weight of used sponges. The 2 groups were compared for age; body mass index; perioperative hemoglobin and hematocrit; perioperative blood loss; duration of surgery; blood transfusion requirements; and the number, total weight, and volume of myomas removed.
RESULTS


A total of 60 patients (30 per arm) were enrolled into the study between March 1, 2015, and January 29, 2018. Age, body mass index, baseline hemoglobin and/or hematocrit, number and total weight of myomas removed, and size of myomas did not differ between arms. Of 60 patients, 32 (53%) had laparoscopic myomectomy, 24 (40%) had robotic myomectomy, and 4 (7%) had laparotomy. Median estimated blood loss was 200 mL for the tranexamic acid group and 240 mL for the placebo group (P=.88). There was no difference in median duration of surgery (165 vs 164 minutes; P=.64) or change in perioperative hemoglobin (1.00 vs 1.1 g/dL; P=.64). Patients in the tranexamic acid group did not require blood transfusions; however, 4 patients (13.3%) in the placebo group (P=.11) required blood transfusions.
CONCLUSION


Intravenous administration of tranexamic acid in patients undergoing laparoscopic or robotic myomectomies was not associated with decreased blood loss.",2020,There was no difference in median duration of surgery (165 versus 164 minutes; p=0.64) or change in perioperative hemoglobin (1.00 versus 1.1 g/dL; p=0.64).,"['Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss based on the following criteria were included in the study', 'academic teaching hospital', 'patients undergoing mostly laparoscopic or robotic myomectomies', 'Sixty patients (30 per arm) were enrolled into the study between March 1, 2015 and January 29, 2018', 'women undergoing a myomectomy']","['placebo', 'Intraoperative Tranexamic Acid', 'Tranexamic acid', 'Placebo', 'tranexamic acid', 'tranexamic 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes prior to initial surgical incision']","['intraoperative estimated blood loss, change between pre- and post-operative hemoglobin, and frequency of blood transfusions', 'body mass index, perioperative hemoglobin and hematocrit, perioperative blood loss, duration of surgery, blood transfusion requirements, and the number, total weight and volume of myomas removed', 'perioperative hemoglobin', 'blood loss', 'perioperative bleeding and blood transfusion requirements', 'Perioperative bleeding', 'blood transfusions', 'Estimated blood loss', 'median duration of surgery', 'Median estimated blood loss', 'Age, body mass index, baseline hemoglobin/hematocrit, number and total weight of myomas', 'Blood Loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C4255212', 'cui_str': 'Myomectomy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.669796,There was no difference in median duration of surgery (165 versus 164 minutes; p=0.64) or change in perioperative hemoglobin (1.00 versus 1.1 g/dL; p=0.64).,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Opoku-Anane', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA. Electronic address: jopokua1@gmail.com.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Vargas', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'Cherie Q', 'Initials': 'CQ', 'LastName': 'Marfori', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Moawad', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'Marloes S', 'Initials': 'MS', 'LastName': 'Maasen', 'Affiliation': 'Department of Obstetrics and Gynecology, George Washington University, Washington, DC.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Robinson', 'Affiliation': 'MedStar Washington Hospital Center, Georgetown University, Washington, DC.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.019']
285,32058423,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Saubhik', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'S. Das, Assistant Professor, Orthopaedics, Rajendra Institute of Medical Sciences (RIMS), Ranchi, India.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001163']
286,31689118,Acute coffee ingestion with and without medium-chain triglycerides decreases blood oxidative stress markers and increases ketone levels.,"Ingestion of ketone supplements, caffeine, and medium-chain triglycerides (MCTs) may all be effective strategies to increase blood levels of the ketone body beta-hydroxybutyrate (D-BHB). However, acute ingestion of a bolus of lipids may increase oxidative stress (OS). The purpose of the study was to investigate the impact of adding varying amounts of MCTs to coffee on blood levels of D-BHB and markers of OS. Ten college-aged men ingested coffee with 0, 28, and 42 g of MCT in a randomized order. Blood samples were collected pre- as well as 2 and 4 h postprandial and analyzed for D-BHB, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c), glucose, triglycerides (TAG), insulin, and OS markers: advanced oxidation protein products (AOPP), glutathione (GSH), malondialdehyde (MDA), and hydrogen peroxide (H 2 O 2 ). All three treatments resulted in a significant increase in D-BHB, HDL-c, and TC as well as a significant decrease in TAG, MDA, H 2 O 2 , and insulin. The 42 g treatment was associated with significantly higher levels of AOPP and MDA. Acute ingestion of coffee results in favorable changes to markers of cardiometabolic health that were not impacted by the addition of 28 g of MCT. However, 42 g of MCT caused significantly greater OS.",2020,"All three treatments resulted in a significant increase in D-BHB, HDL-c, and TC, as well as a significant decrease in TAG, MDA, H2O2, and insulin.","['Ten college-aged men ingested coffee with 0g, 28g, and 42g of']","['Acute coffee ingestion with and without medium chain triglycerides', 'MCT', 'ketone supplements, caffeine and medium chain triglycerides (MCTs']","['D-BHB, HDL-c, and TC, as well as a significant decrease in TAG, MDA, H2O2, and insulin', 'cardiometabolic health', 'blood levels of D-BHB and markers of OS', 'oxidative stress (OS', 'OS', 'D-BHB, total cholesterol (TC), high density lipoprotein cholesterol (HDL-c), glucose, triglycerides (TAG), insulin, as well as OS markers: advanced oxidation protein products (AOPP), glutathione (GSH), malondialdehyde (MDA), and hydrogen peroxide (H2O2', 'levels of AOPP and MDA', 'ketone levels', 'blood oxidative stress markers']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C3164740', 'cui_str': '28 gauge (qualifier value)'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1976991', 'cui_str': 'AOPPs'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}]",,0.0621585,"All three treatments resulted in a significant increase in D-BHB, HDL-c, and TC, as well as a significant decrease in TAG, MDA, H2O2, and insulin.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McAllister', 'Affiliation': 'Metabolic and Applied Physiology Laboratory, Department of Health and Human Performance, Texas State University, San Marcos, TX 78666, USA.'}, {'ForeName': 'Hunter S', 'Initials': 'HS', 'LastName': 'Waldman', 'Affiliation': 'Department of Kinesiology, University of North Alabama, Florence, AL 35632, USA.'}, {'ForeName': 'Liliana I', 'Initials': 'LI', 'LastName': 'Rentería', 'Affiliation': 'Metabolic and Applied Physiology Laboratory, Department of Health and Human Performance, Texas State University, San Marcos, TX 78666, USA.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Gonzalez', 'Affiliation': 'Metabolic and Applied Physiology Laboratory, Department of Health and Human Performance, Texas State University, San Marcos, TX 78666, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Butawan', 'Affiliation': 'School of Health Studies, University of Memphis, Memphis, TN 38152, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'School of Health Studies, University of Memphis, Memphis, TN 38152, USA.'}]",Canadian journal of physiology and pharmacology,['10.1139/cjpp-2019-0458']
287,31916011,Effect of an endoscopic bite block on one-handed mask ventilation.,"PURPOSE


An endoscopic bite block is a device to ensure that the patient's mouth remains wide open during endoscopic procedures. Wide opening of the mouth may facilitate the efficiency of one-handed mask ventilation. We evaluated the effect of an endoscopic bite block on mask ventilation among three ventilation techniques: one-handed ventilation, one-handed ventilation with an endoscopic bite block, and two-handed ventilation.
METHODS


Fifty-nine anesthetized and paralyzed patients were included. After induction of anesthesia, one-handed ventilation, one-handed ventilation with an endoscopic bite block and two-handed ventilation were performed in a cross-over, randomized order. The primary outcome was the expiratory tidal volume (mL/kg of predicted body weight). Secondary outcomes included minute ventilation (L/min) and the incidence of inadequate mask ventilation or dead space ventilation.
RESULTS


The expiratory tidal volume of one-handed ventilation with an endoscopic bite block was significantly improved when compared with that of one-handed ventilation (8.2 [6.8-10.2] mL/kg vs. 7.1 [4.5-9.0] mL/kg, respectively, difference = 1.1 mL/kg; 95% CI 0.8-2.4; P < 0.001), and was comparable to that of two-handed ventilation (8.9 [6.3-11.5] mL/kg; difference = 0.7 mL/kg; 95% CI - 0.7 to 1.5; P = 0.432). Minute ventilation was also significantly improved in one-handed ventilation with an endoscopic bite block compared with that in one-handed ventilation (7.4 [6.3-8.6] L/min vs. 6.7 [4.2-7.9] L/min, respectively, difference = 0.7 L/min; 95% CI 0.6-2.0; P < 0.001), and was comparable to that of two-handed ventilation (7.7 [6.5-9.5] L/min; difference = 0.3 L/min; 95% CI - 0.5 to 1.4; P = 0.390). The incidence of inadequate ventilation or dead space ventilation was not different among the ventilation techniques (P = 0.080).
CONCLUSION


The use of an endoscopic bite block improved one-handed mask ventilation, showing comparable efficacy with two-handed mask ventilation.",2020,"The incidence of inadequate ventilation or dead space ventilation was not different among the ventilation techniques (P = 0.080).
","['Fifty-nine', 'anesthetized and paralyzed patients']","['anesthesia, one-handed ventilation, one-handed ventilation with an endoscopic bite block and two-handed ventilation', 'endoscopic bite block']","['expiratory tidal volume of one-handed ventilation with an endoscopic bite block', 'incidence of inadequate ventilation or dead space ventilation', 'minute ventilation (L/min) and the incidence of inadequate mask ventilation or dead space ventilation', 'expiratory tidal volume (mL/kg of predicted body weight', 'Minute ventilation']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C1720436', 'cui_str': 'Anesthetized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0179321', 'cui_str': 'Bite block (physical object)'}]","[{'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0179321', 'cui_str': 'Bite block (physical object)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",59.0,0.0825687,"The incidence of inadequate ventilation or dead space ventilation was not different among the ventilation techniques (P = 0.080).
","[{'ForeName': 'Hyerim', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jee-Eun', 'Initials': 'JE', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dongwook', 'Initials': 'D', 'LastName': 'Won', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Jun', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Young', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea. mistyblue15@naver.com.'}]",Journal of anesthesia,['10.1007/s00540-019-02732-3']
288,31741073,Single Dose Steroid Injection After Loss of Signal (LOS) During Thyroid Surgery is Effective to Recover Electric Signal Avoiding Vocal Cord Palsy and the Need of Staged Thyroidectomy: Prospective Evaluation on 702 Patients.,"BACKGROUND


Steroids are often used for the management of vocal cord palsy after thyroid surgery. There are no reports in the current literature of their intraoperative use, immediately after a loss of signal during neuromonitoring (LOS). We evaluate the impact of a single dose of 4 mg of dexamethasone on laryngeal nerve function, administrated at the time of a LOS during a nerve-monitored thyroidectomy.
METHODS


A prospective not randomized study was performed, dividing patients in two groups, when a LOS was detected. LOS was defined as an electromyographic signal (EMG) inferior to 100 μV when stimulating the inferior laryngeal nerve, according to international guidelines. In group 1 (G1), surgeon waits for signal's recovery up to 20 min. Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy. In group 2 (G2), 4 mg of dexamethasone were injected within 10 min from a detected LOS, waiting 10 min for its effects. An EMG value > to 200 μV within 20' after steroid administration was predictive of full recovery and normal post-operatory vocal cord function. Vocal cords motility was checked at postoperative day 1 in all patients by an experienced ENT.
RESULTS


Between January 2017 and December 2018, 702 patients underwent thyroid surgery under intermittent intraoperative nerve monitoring by two expert surgeons. A LOS was found in 22 patients in G1 and 16 in G2. Four patients in G1 spontaneously recovered electric signal (18.2%), while in G2 a signal was recovered in 14/16 patients (87.5%) (p < 0.001). This immediate effect was monitored by EMG, showing the increase in potentials at 10, 15 and 20 min after injection. ENT evaluation found vocal cord palsy, respectively, in 18/22 and 1/16 patients (G1 vs G2, p < 0.001). One of the patients in G2 who recovered electric signal presented transient palsy, fully recovered at 2 months, while the two patients who had a signal < 200 μV did not present postoperative cord palsy. In G1, 10/18 palsy were definitive. No permanent palsies were presents in G2.
CONCLUSION


A single 4 mg iv dexamethasone injection within 10 min form a LOS during thyroid surgery exerts a therapeutic action, measurable by EMG modifications. It avoids vocal nerve palsy and the need of a staged thyroidectomy. It may also protect from permanent cord palsy, but the mechanism is unknown.",2020,Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy.,"['Between January 2017 and December 2018, 702 patients underwent thyroid surgery under intermittent intraoperative nerve monitoring by two expert surgeons', '702 Patients', 'vocal cord palsy after thyroid surgery', '22 patients in G1 and 16 in G2']","['Steroid Injection', 'Staged Thyroidectomy', 'dexamethasone', 'Signal (LOS']","['LOS', 'Vocal cords motility', 'electric signal', 'vocal cord palsy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}]",702.0,0.0914179,Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy.,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Donatini', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France. Giacko76@hotmail.com.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Danion', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zerrweck', 'Affiliation': 'ABC Hospital, Mexico City, Mexico.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Etienne', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Lacoste', 'Affiliation': 'Department of Anesthesia CHU Poitiers, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Kraimps', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}]",World journal of surgery,['10.1007/s00268-019-05295-2']
289,32039956,Reply to the Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.0971855,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001164']
290,32020373,Perseus A500 enables faster recovery from desflurane general anesthesia.,"PURPOSE


The Dräger Perseus A500 (Perseus) anesthetic workstation has been designed with a lower internal volume. We evaluated the recovery time following general anesthesia using the Perseus workstation compared with that using the conventional Dräger Fabius Plus workstation.
METHODS


Following approval by our institutional research ethics committee, 50 patients receiving elective surgery under general anesthesia were enrolled in the study. Written informed consent was obtained from each patient. The patients were divided into the Perseus group and a control group. The Perseus anesthesia workstation was used for the Perseus group, and the Fabius Plus was used for the control group. General anesthesia was maintained with a 4.2% end-tidal concentration of desflurane, remifentanil, fentanyl, and regional anesthesia. After the surgical procedure, the administration of desflurane was discontinued. The inspiratory and expiratory desflurane concentration, time taken for patients to open their eyes, and the time taken to extubate the trachea after discontinuation of anesthetics were recorded.
RESULTS


The inspiratory and expiratory desflurane concentration after the administration of desflurane was discontinued was lower in the Perseus group. Moreover, the time taken for patients to open their eyes was statistically significantly quicker in the Perseus group when compared with the control group: 284 ± 60 vs 325 ± 43 s, respectively. The time taken for extubation was also statistically significantly quicker in the Perseus group when compared with the control group: 350 ± 67 vs 388 ± 62 s, respectively.
CONCLUSIONS


We demonstrate in this study that Perseus enables the faster wash-out of anesthetics and faster recovery of patients after general anesthesia.",2020,"The time taken for extubation was also statistically significantly quicker in the Perseus group when compared with the control group: 350 ± 67 vs 388 ± 62 s, respectively.
",['50 patients receiving elective surgery under general anesthesia were enrolled in the study'],"['desflurane', 'desflurane, remifentanil, fentanyl, and regional anesthesia']","['inspiratory and expiratory desflurane concentration, time taken', 'time taken for extubation', 'recovery time', 'inspiratory and expiratory desflurane concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]",,0.0161679,"The time taken for extubation was also statistically significantly quicker in the Perseus group when compared with the control group: 350 ± 67 vs 388 ± 62 s, respectively.
","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Morimoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan. yasumorimo@gmail.com.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Shiramoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Shimamoto', 'Affiliation': 'Department of Anesthesia, Ube Industries Central Hospital, 750 Nishikiwa, Ube, Yamaguchi, 755-0151, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02740-8']
291,32072879,Does it matter who's at risk?: Testing message framing and narrative as moderators of the effects of self-referencing in obesity prevention messages targeting Hispanic adults living in the U.S.,"This study tested whether the effect of self-referencing in a health-marketing message was amplified or attenuated when combined with message framing and narrative. Hispanic adults ( N  = 146) were randomly assigned to read and respond to an obesity prevention message. Self-referencing messages generated greater cognitive elaboration but only when placed in a narrative. Conversely, self-referencing messages highlighting health risks of obesity produced higher levels of involvement and intention to increase physical activity and healthy eating. Health marketing professionals can use these findings to enhance the effectiveness of obesity prevention messages that target Hispanic adults.",2020,"Conversely, self-referencing messages highlighting health risks of obesity produced higher levels of involvement and intention to increase physical activity and healthy eating.","['Hispanic adults', 'Hispanic adults ( N \u2009=\u2009146', 'Hispanic adults living in the U.S']",['self-referencing'],"['cognitive elaboration', 'physical activity and healthy eating']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}]",146.0,0.0304959,"Conversely, self-referencing messages highlighting health risks of obesity produced higher levels of involvement and intention to increase physical activity and healthy eating.","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Wirtz', 'Affiliation': 'Charles H. Sandage Department of Advertising, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",Health marketing quarterly,['10.1080/07359683.2020.1713576']
292,30770517,Cyclophosphamide for Systemic Sclerosis-related Interstitial Lung Disease: A Comparison of Scleroderma Lung Study I and II.,"OBJECTIVE


To compare safety and efficacy outcomes between the cyclophosphamide (CYC) arms of Scleroderma Lung Study (SLS) I and II.
METHODS


Participants enrolled in the CYC arms of SLS I (n = 79) and II (n = 69) were included. SLS I and II randomized participants to oral CYC for 1 year and followed patients for an additional year off therapy (in SLS II, patients received placebo in Year 2). Eligibility criteria for SLS I and II were nearly identical. Outcomes included the forced vital capacity (FVC%)-predicted and DLCO%-predicted (measured every 3 mos) and quantitative radiographic extent of interstitial lung disease (measured at 1 and 2 yrs for SLS I and SLS II, respectively). Joint models were created to evaluate the treatment effect on the course of the FVC/DLCO over 2 years while controlling for baseline disease severity.
RESULTS


SLS I and II CYC participants had similar baseline characteristics. After adjusting for baseline disease severity, there was no difference in the course of the FVC%-predicted (p = 0.535) nor the DLCO%-predicted (p = 0.172) between the SLS I and II CYC arms. In both groups, treatment with CYC led to a significant improvement in the FVC%-predicted from 3 to 12 months, but no significant improvement beyond this point. Treatment with CYC had no effect on the DLCO for either group.
CONCLUSION


Treatment with 1 year of oral CYC led to similar improvements in lung function in both SLS I and II, although the effects were not sustained following cessation of CYC. These results suggest that increasing the duration of ILD therapy may improve outcomes for patients with systemic sclerosis-ILD.",2019,"In both groups, treatment with CYC led to a significant improvement in the FVC%-predicted from 3 to 12 months, but no significant improvement beyond this point.","['patients with systemic sclerosis-ILD', 'Systemic Sclerosis-related Interstitial Lung Disease', 'Participants enrolled in the CYC arms of SLS I (n = 79) and II (n = 69) were included']","['placebo', 'DLCO', 'oral CYC', 'SLS', 'Cyclophosphamide', 'cyclophosphamide (CYC']","['lung function', 'forced vital capacity (FVC%)-predicted and DLCO%-predicted (measured every 3 mos) and quantitative radiographic extent of interstitial lung disease', 'FVC%-predicted', 'safety and efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",69.0,0.0521788,"In both groups, treatment with CYC led to a significant improvement in the FVC%-predicted from 3 to 12 months, but no significant improvement beyond this point.","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway. evolkmann@mednet.ucla.edu.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Myung', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Hoffmann-Vold', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'From the Department of Medicine and Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, California; Department of Biomathematics, University of California, Los Angeles, California; Department of Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA; Department of Rheumatology, Oslo University Hospital, Oslo, Norway.'}]",The Journal of rheumatology,['10.3899/jrheum.180441']
293,31988481,Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.,"BACKGROUND


The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness.
METHODS


Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained.
RESULTS


Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY.
CONCLUSIONS


Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.",2020,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","['pupils eligible for free school meals, 20 schools', 'Forty schools']","['Daily Mile', 'Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented']","['Effectiveness and cost-effectiveness', 'physical activity levels', 'childhood weight outcomes and wellbeing', 'BMI z-score (BMIz', 'BMIz', 'incremental cost per Quality-Adjusted-Life-Year (QALY) gained']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",40.0,0.246083,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Breheny', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Passmore', 'Affiliation': 'Services for Education, Birmingham, B7 4AX, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. p.adab@bham.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. e.frew@bham.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-019-0511-0']
294,31863189,Prophylactic diphenhydramine attenuates postoperative catheter-related bladder discomfort in patients undergoing gynecologic laparoscopic surgery: a randomized double-blind clinical study.,"BACKGROUND


To evaluate the effectiveness of diphenhydramine, an antihistamine with anti-muscarinic properties, for prevention of postoperative catheter-related bladder discomfort (CRBD).
METHODS


Ninety-six ASA physical status I and II adult female patients (20-60 years) scheduled for elective gynecologic laparoscopic surgery were included. Patients were randomized into two groups of 48 patients each. All patients received a detailed preoperative explanation of the possible consequences of CRBD. The control group received normal saline 2 ml, whereas the diphenhydramine group received diphenhydramine 30 mg intravenously after induction of general anesthesia. Then, all patients were catheterized with a 14F Foley catheter and the balloon was inflated with 10 ml of distilled water. All patients who complained of CRBD in the postoperative room were appeased with nursing. Ketorolac 30 mg was used as the rescue drug on patients' request or when the patient was evaluated as having moderate or severe CRBD. Bladder discomfort and its severity were assessed at 1, 2 and 6 h postoperatively. The severity of CRBD was graded as none, mild, moderate and severe. Adverse effects of diphenhydramine such as sedation, dry mouth or GI upset were recorded.
RESULTS


The incidence of CRBD was lower in the diphenhydramine group compared with the control group at 2 h (34.8 vs. 58.7%, p = 0.02) and 6 h (23.9 vs. 56.5%, p < 0.01) postoperatively. Diphenhydramine treatment also reduced the severity of CRBD at 6 h postoperatively (p = 0.01). Moreover, the request for rescue for CRBD was lower in diphenhydramine group at 2 h (8.7 vs. 26.1%, p = 0.03). There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
CONCLUSION


Prophylactic diphenhydramine 30 mg at induction of general anesthesia reduced the incidence and severity of postoperative bladder discomfort without significant side effects in patients receiving gynecologic laparoscopic surgery.",2020,"There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
","['patients undergoing gynecologic laparoscopic surgery', 'Ninety-six ASA physical status', 'patients receiving gynecologic laparoscopic surgery', 'All patients who complained of CRBD in the postoperative room were appeased with nursing', 'I and II adult female patients (20-60\xa0years) scheduled for']","['Ketorolac', '14F Foley catheter and the balloon was inflated with 10\xa0ml of distilled water', 'Prophylactic diphenhydramine', 'normal saline 2\xa0ml', 'elective gynecologic laparoscopic surgery', 'diphenhydramine 30\xa0mg intravenously after induction of general anesthesia', 'diphenhydramine', 'Diphenhydramine']","['severity of CRBD', 'side effects, such as sedation, dry mouth or gastrointestinal upset', 'incidence of CRBD', 'Bladder discomfort and its severity', 'sedation, dry mouth or GI upset', 'request for rescue for CRBD', 'postoperative catheter-related bladder discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0179804'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",96.0,0.160389,"There were no significant differences in side effects, such as sedation, dry mouth or gastrointestinal upset between the two groups (p > 0.05).
","[{'ForeName': 'Yu-Yu', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Yan-Syun', 'Initials': 'YS', 'LastName': 'Zeng', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Jen-Yin', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Kuei-Fen', 'Initials': 'KF', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Chung-Hsi', 'Initials': 'CH', 'LastName': 'Hsing', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Wen-Ju', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Jhi-Joung', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Ping-Hsun', 'Initials': 'PH', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan.'}, {'ForeName': 'Chin-Chen', 'Initials': 'CC', 'LastName': 'Chu', 'Affiliation': 'Department of Anesthesiology, Chi Mei Medical Center, 901 Zhonghua Road, Yong Kang District, Tainan City, 71004, Taiwan. chinchen.chu@gmail.com.'}]",Journal of anesthesia,['10.1007/s00540-019-02724-3']
295,30877638,Dementia Family Caregivers' Willingness to Pay for an In-home Program to Reduce Behavioral Symptoms and Caregiver Stress.,"OBJECTIVES


Our objective was to determine whether family caregivers of people with dementia (PwD) are willing to pay for an in-home intervention that provides strategies to manage behavioral symptoms and caregiver stress and to identify predictors of willingness-to-pay (WTP).
METHODS


During baseline interviews of a randomized trial and before treatment assignment, caregivers were asked how much they were willing to pay per session for an eight-session program over 3 months. We stratified the sample into those who refused to provide a WTP, those willing to pay $US0, and those willing to pay > $US0. We used a two-part model, controlling for demographic characteristics, to predict adjusted mean WTP and to examine associations between WTP, clinical features (cognition, function, behavioral symptoms), and time spent assisting PwD with daily activities. First, we used logistic regression to model the probability a caregiver was willing to pay > $US0. Second, we used a generalized linear model (log link and Gamma distribution) to estimate the amount caregivers were willing to pay conditional on WTP > $US0.
RESULTS


Of 250 dyads enrolled, 226 (90%) had complete data and were included in our analyses. Of 226 dyads, 26 (11%) refused to provide a WTP value, 72 (32%) were willing to pay $US0, and 128 (57%) were willing to pay > $US0. In the combined model, mean adjusted WTP was $US36.00 (95% confidence interval [CI] 26.72-45.27) per session. Clinical features were not significantly associated with WTP. One additional hour providing PwD assistance was associated with a $US1.64 (95% CI 0.23-3.04) increase in WTP per session.
CONCLUSION


As caregivers spend more time assisting with daily activities, they are willing to pay more for a supportive program.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01892579.",2019,"One additional hour providing PwD assistance was associated with a $US1.64 (95% CI 0.23-3.04) increase in WTP per session.
","['family caregivers of people with dementia (PwD', 'Of 250 dyads enrolled, 226 (90%) had complete data and were included in our analyses', 'Of 226 dyads, 26 (11%) refused to provide a WTP value, 72 (32%) were willing to pay $US0, and 128 (57%) were willing to pay\u2009>\u2009$US0']",[],"['WTP, clinical features (cognition, function, behavioral symptoms), and time spent assisting PwD with daily activities']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",250.0,0.0555595,"One additional hour providing PwD assistance was associated with a $US1.64 (95% CI 0.23-3.04) increase in WTP per session.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jutkowitz', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Box G-S121-6, 121 S. Main Street, 6th Floor, Providence, RI, 02912, USA. Eric_Jutkowitz@Brown.edu.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Scerpella', 'Affiliation': 'Johns Hopkins University Center for Innovative Care in Aging, Baltimore, MD, USA.'}, {'ForeName': 'Laura T', 'Initials': 'LT', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Rutgers University Ernest Mario School of Pharmacy, Piscataway, NJ, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marx', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Samus', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Catherine Verrier', 'Initials': 'CV', 'LastName': 'Piersol', 'Affiliation': 'Department of Occupational Therapy, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Johns Hopkins University Center for Innovative Care in Aging, Baltimore, MD, USA.'}]",PharmacoEconomics,['10.1007/s40273-019-00785-6']
296,31738372,Minocycline at 2 Different Dosages vs Placebo for Patients With Mild Alzheimer Disease: A Randomized Clinical Trial.,"Importance


There are no disease-modifying treatments for Alzheimer disease (AD), the most common cause of dementia. Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
Objective


To determine whether 24 months of minocycline treatment can modify cognitive and functional decline in patients with mild AD.
Design, Setting, and Participants


Participants were recruited into a double-blind randomized clinical trial from May 23, 2014, to April 14, 2016, with 24 months of treatment and follow-up. This multicenter study in England and Scotland involved 32 National Health Service memory clinics within secondary specialist services for people with dementia. From 886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized.
Interventions


Participants were randomly allocated 1:1:1 in a semifactorial design to receive minocycline (400 mg/d or 200 mg/d) or placebo for 24 months.
Main Outcomes and Measures


Primary outcome measures were decrease in sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression.
Results


Of 544 eligible participants (241 women and 303 men), the mean (SD) age was 74.3 (8.2) years, and the mean (SD) sMMSE score was 26.4 (1.9). Fewer participants completed 400-mg minocycline hydrochloride treatment (28.8% [53 of 184]) than 200-mg minocycline treatment (61.9% [112 of 181]) or placebo (63.7% [114 of 179]; P < .001), mainly because of gastrointestinal symptoms (42 in the 400-mg group, 15 in the 200-mg group, and 10 in the placebo group; P < .001), dermatologic adverse effects (10 in the 400-mg group, 5 in the 200-mg group, and 1 in the placebo group; P = .02), and dizziness (14 in the 400-mg group, 3 in the 200-mg group, and 1 in the placebo group; P = .01). Assessment rates were lower in the 400-mg group: 68.4% (119 of 174 expected) for sMMSE at 24 months compared with 81.8% (144 of 176) for the 200-mg group and 83.8% (140 of 167) for the placebo group. Decrease in sMMSE scores over 24 months in the combined minocycline group was similar to that in the placebo group (4.1 vs 4.3 points). The combined minocycline group had mean sMMSE scores 0.1 points higher than the placebo group (95% CI, -1.1 to 1.2; P = .90). The decrease in mean sMMSE scores was less in the 400-mg group than in the 200-mg group (3.3 vs 4.7 points; treatment effect = 1.2; 95% CI, -0.1 to 2.5; P = .08). Worsening of BADLS scores over 24 months was similar in all groups: 5.7 in the 400-mg group, 6.6 in the 200-mg group, and 6.2 in the placebo groups (treatment effect for minocycline vs placebo = -0.53; 95% CI, -2.4 to 1.3; P = .57; treatment effect for 400 mg vs 200 mg of minocycline = -0.31; 95% CI, -0.2 to 1.8; P = .77). Results were similar in different patient subgroups and in sensitivity analyses adjusting for missing data.
Conclusions and Relevance


Minocycline did not delay the progress of cognitive or functional impairment in people with mild AD during a 2-year period. This study also found that 400 mg of minocycline is poorly tolerated in this population.
Trial Registration


isrctn.org Identifier: ISRCTN16105064.",2020,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","['544 eligible participants (241 women and 303 men', 'patients with mild AD', 'Patients With Mild Alzheimer Disease', '32 National Health Service memory clinics within secondary specialist services for people with dementia', '886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized']","['Placebo', 'minocycline hydrochloride', 'placebo', 'minocycline', 'Minocycline']","['Assessment rates', 'gastrointestinal symptoms', 'sMMSE scores', 'dermatologic adverse effects', 'cognitive and functional decline', 'Worsening of BADLS scores', 'mean sMMSE scores', 'sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression', 'mean (SD) sMMSE score', 'dizziness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026186', 'cui_str': 'Minocycline Hydrochloride'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",554.0,0.722529,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Zubko', 'Affiliation': ""Old Age Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Medical Research Council Population Health Research Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harper', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Pank', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Tabet', 'Affiliation': 'Department of Old Age Psychiatry, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'Birmingham and Solihull Mental Health National Health Service Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Department of Old Age Psychiatry, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lovestone', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'Medical School, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Noble', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership National Health Service Foundation Trust, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.3762']
297,31898198,Sitting or Walking? Analyzing the Neural Emotional Indicators of Urban Green Space Behavior with Mobile EEG.,"There is a close relationship between urban green space and the physical and mental health of individuals. Most previous studies have discussed the impact of the structure of green space and its elements. This study focused on the emotional changes caused by common behaviors in urban green space (walking and sitting). We recruited 40 college students and randomly assigned them to walking and sitting groups (20 students per group). The two groups performed the same 8-min high-pressure learning task indoors and then performed 8-min recovery activities in a simulated urban green space (a bamboo-lawn space). We used the Emotiv EPOC+ EEG headset to dynamically measure six neural emotional parameters: ""engagement,"" ""valence,"" ""meditation,"" ""frustration,"" ""focus,"" and ""excitement."" We conducted a pretest and posttest and used analysis of covariance (ANCOVA) to analyze the posttest data (with the pretest data as covariates). The results of the comparison of the two behaviors showed that the ""valence"" and ""meditation"" values of the walking group were higher than those of the sitting group, which suggests that walking in urban green space is more favorable for stress reduction. The sitting group had a higher ""focus"" value than did the walking group, which suggests that sitting in urban green space is better for attention restoration. The results of this study can provide guidance for urban green space planning and design as well as health guidance for urban residents.",2020,"The sitting group had a higher ""focus"" value than did the walking group, which suggests that sitting in urban green space is better for attention restoration.","['urban residents', '40 college students', 'urban green space (walking and sitting']",['Emotiv EPOC+ EEG headset'],"['valence"" and ""meditation"" values']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0150277'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6.0,0.0202801,"The sitting group had a higher ""focus"" value than did the walking group, which suggests that sitting in urban green space is better for attention restoration.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Qibing', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China. cqb@sicau.edu.cn.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Zongfang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Linjia', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Yushan', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}, {'ForeName': 'Qiuyuan', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, 611130, Sichuan, China.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-019-00407-8']
298,30777122,Study protocol for a pragmatic trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) model for engaging patients in opioid use disorder treatment.,"BACKGROUND


Treatment for opioid use disorder (OUD) is highly effective, yet it remains dramatically underutilized. Individuals with OUD have disproportionately high rates of hospitalization and low rates of addiction treatment. Hospital-based addiction consult services offer a potential solution by using multidisciplinary teams to evaluate patients, initiate medication for addiction treatment (MAT) in the hospital, and connect patients to post-discharge care. We are studying the effectiveness of an addiction consult model [Consult for Addiction Treatment and Care in Hospitals (CATCH)] as a strategy for engaging patients with OUD in treatment as the program rolls out in the largest municipal hospital system in the US. The primary aim is to evaluate the effectiveness of CATCH in increasing post-discharge initiation and engagement in MAT. Secondary aims are to assess treatment retention, frequency of acute care utilization and overdose deaths and their associated costs, and implementation outcomes.
METHODS


A pragmatic trial at six hospitals, conducted in collaboration with the municipal hospital system and department of health, will be implemented to study the CATCH intervention. Guided by the RE-AIM evaluation framework, this hybrid effectiveness-implementation study (Type 1) focuses primarily on effectiveness and also measures implementation outcomes to inform the intervention's adoption and sustainability. A stepped-wedge cluster randomized trial design will determine the impact of CATCH on treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a 6- to 18-month maintenance period at each hospital. A mixed methods approach will primarily utilize administrative data to measure outcomes, while interviews and focus groups with staff and patients will provide additional information on implementation fidelity and barriers to delivering MAT to patients with OUD.
DISCUSSION


Because of their great potential to reduce the negative health and economic consequences of untreated OUD, addiction consult models are proliferating in response to the opioid epidemic, despite the absence of a strong evidence base. This study will provide the first known rigorous evaluation of an addiction consult model in a large multi-site trial and promises to generate knowledge that can rapidly transform practice and inform the potential for widespread dissemination of these services.
TRIAL REGISTRATION


NCT03611335.",2019,"A stepped-wedge cluster randomized trial design will determine the impact of CATCH on treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a 6- to 18-month maintenance period at each hospital.","['in Hospitals (CATCH', 'engaging patients with OUD in treatment as the program rolls out in the largest municipal hospital system in the US', 'engaging patients in opioid use disorder treatment', 'six hospitals, conducted in collaboration with the municipal hospital system and department of health']","['addiction consult model [Consult for Addiction Treatment and Care', 'CATCH']","['treatment retention, frequency of acute care utilization and overdose deaths']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020013', 'cui_str': 'Hospitals, City, Public-Owned'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",6.0,0.0585379,"A stepped-wedge cluster randomized trial design will determine the impact of CATCH on treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a 6- to 18-month maintenance period at each hospital.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McNeely', 'Affiliation': 'Department of Population Health, Section on Alcohol, Tobacco and Drug Use, NYU School of Medicine, 180 Madison Avenue, 17th floor, New York, NY, 10016, USA. Jennifer.McNeely@nyulangone.org.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, 180 Madison Avenue, 5th floor, New York, NY, 10016, USA.'}, {'ForeName': 'Hillary V', 'Initials': 'HV', 'LastName': 'Kunins', 'Affiliation': 'NYC Department of Health and Mental Hygiene, Bureau of Alcohol and Drug Use Prevention Care and Treatment, 42-09 28th Street, Room CN14, Queens, NY, 11101, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, Section on Alcohol, Tobacco and Drug Use, NYU School of Medicine, 180 Madison Avenue, 17th floor, New York, NY, 10016, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, Section on Alcohol, Tobacco and Drug Use, NYU School of Medicine, 180 Madison Avenue, 17th floor, New York, NY, 10016, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Walley', 'Affiliation': 'Clinical Addiction Research and Education Unit, Boston University School of Medicine, 801 Massachusetts Ave., 2nd Foor, Boston, MA, 02118, USA.'}, {'ForeName': 'Zoe M', 'Initials': 'ZM', 'LastName': 'Weinstein', 'Affiliation': 'Clinical Addiction Research and Education Unit, Boston University School of Medicine, 801 Massachusetts Ave., 2nd Foor, Boston, MA, 02118, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'Wagner School of Health Policy and Public Service, New York University, 295 Lafayette Street, New York, NY, 10012, USA.'}, {'ForeName': 'Nichola J', 'Initials': 'NJ', 'LastName': 'Davis', 'Affiliation': 'Office of Population Health, NYC Health and Hospitals, 199 Water Street, New York, NY, 10038, USA.'}, {'ForeName': 'Roopa Kalyanaraman', 'Initials': 'RK', 'LastName': 'Marcello', 'Affiliation': 'Office of Population Health, NYC Health and Hospitals, 199 Water Street, New York, NY, 10038, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Healthcare Policy and Research, Weill Cornell Medical College, 425 E. 61st St., Ste 301, New York, NY, 10065, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Barron', 'Affiliation': 'Office of Behavioral Health, NYC Health\u2009+\u2009Hospitals, 125 Worth St, New York, NY, 10013, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bergmann', 'Affiliation': 'Office of Behavioral Health, NYC Health\u2009+\u2009Hospitals, 125 Worth St, New York, NY, 10013, USA.'}]",Addiction science & clinical practice,['10.1186/s13722-019-0135-7']
299,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
300,31926224,Effectiveness of Brief and Standard School-Based Cognitive-Behavioral Interventions for Adolescents With Anxiety: A Randomized Noninferiority Study.,"OBJECTIVE


We examined the effectiveness of targeted school-based cognitive-behavioral therapy (CBT) for adolescents (12-16 years of age) with anxiety, and tested whether brief CBT was noninferior to standard duration CBT.
METHOD


A randomized controlled study of 313 adolescents (mean 14.0 years, SD = 0.84, 84% girls) were recruited through school health services to 10 weeks CBT group interventions. Groups of 5 to 8 adolescents were randomly allocated to brief (5 sessions, comprising 5.5 hours) or standard CBT (10 sessions, comprising 15 hours), or 10 weeks waitlist (WL). Self-reported and parent-reported youth anxiety symptoms, impairment from anxiety, depressive symptoms,and clinical severity were assessed pre- and postintervention, after WL, and at 1-year follow-up.
RESULTS


Targeted school based CBT significantly reduced adolescents' anxiety symptoms with small to moderate effect sizes compared to WL (Cohen d = 0.34 for youth report and d = 0.53 for parent report). According to the parents, also adolescents' impairment from anxiety was significantly reduced compared to WL (d = 0.51). Pre to post changes in anxiety symptoms were small to moderate (within-group effect sizes between d = 0.41 and d = 0.67). Although no significant differences in effects were found between brief and standard CBT, brief CBT was not noninferior to standard CBT. Outcomes from both interventions were sustained at 1-year follow-up.
CONCLUSION


Targeted school-based CBT interventions reduced anxiety, impairment, and depressive symptoms in adolescents. Both brief and standard CBT demonstrated efficacy, but brief CBT was not noninferior to standard CBT. By administering school-based CBT to youths with anxiety symptoms, we may reach young people with effective interventions at an earlier phase in their lives.
CLINICAL TRIAL REGISTRATION INFORMATION


School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth (LIST); http://clinicalrials.gov/; NCT02279251.",2020,Targeted school based CBT significantly reduced adolescents' anxiety symptoms with small to moderate effect sizes compared to WL (Cohen's d= 0.34 for youth report and d=0.53 for parent report).,"['adolescents', 'Adolescents With Anxiety', '313 adolescents (mean 14.0 years, SD= 0.84, 84% girls) were recruited through school-health services to 10-weeks CBT group-interventions', 'Groups of 5-8 adolescents', 'adolescents (12-16 years) with anxiety, and tested whether brief-CBT was non-inferior to standard duration CBT']","['Targeted school-based CBT-interventions', 'Brief and Standard School-Based Cognitive-Behavioral Interventions', 'targeted school-based cognitive-behavioral therapy (CBT', 'standard-CBT', 'school-based CBT']","[""adolescents' anxiety symptoms"", 'anxiety symptoms', ""adolescents' impairment from anxiety""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036371', 'cui_str': 'School-Based Health Services'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",313.0,0.0424656,Targeted school based CBT significantly reduced adolescents' anxiety symptoms with small to moderate effect sizes compared to WL (Cohen's d= 0.34 for youth report and d=0.53 for parent report).,"[{'ForeName': 'Bente Storm Mowatt', 'Initials': 'BSM', 'LastName': 'Haugland', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian Research Center, NORCE, Bergen, Norway; University of Bergen, Norway. Electronic address: bente.haugland@uib.no.'}, {'ForeName': 'Åshild Tellefsen', 'Initials': 'ÅT', 'LastName': 'Haaland', 'Affiliation': 'Sorlandet Hospital HF, Kristiansand, Norway.'}, {'ForeName': 'Valborg', 'Initials': 'V', 'LastName': 'Baste', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian Research Center, NORCE, Bergen, Norway.'}, {'ForeName': 'Jon Fauskanger', 'Initials': 'JF', 'LastName': 'Bjaastad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian Research Center, NORCE, Bergen, Norway; Division of Psychiatry, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Centre, Vikersund, Norway; University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Raknes', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian Research Center, NORCE, Bergen, Norway.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Himle', 'Affiliation': 'University of Michigan, Ann Arbor; School of Social Work, University of Michigan, Ann Arbor.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Husabø', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian Research Center, NORCE, Bergen, Norway; Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Gro Janne', 'Initials': 'GJ', 'LastName': 'Wergeland', 'Affiliation': 'Faculty of Medicine, University of Bergen, Bergen, Norway; Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.12.003']
301,32222135,Rivaroxaban in Peripheral Artery Disease after Revascularization.,"BACKGROUND


Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain.
METHODS


In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome.
RESULTS


A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007).
CONCLUSIONS


In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).",2020,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","['patients with peripheral artery disease who had undergone lower-extremity revascularization', 'patients with peripheral artery disease who had undergone revascularization', '508 patients in the', 'Peripheral Artery Disease after Revascularization', 'Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events', '6564 patients underwent randomization; 3286 were assigned to the']","['aspirin', 'placebo', 'Rivaroxaban', 'aspirin or placebo plus aspirin', 'rivaroxaban']","['composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'efficacy and safety', 'TIMI major bleeding', 'incidence of TIMI major bleeding', 'ISTH major bleeding', 'incidence of ISTH major bleeding', 'acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'Kaplan-Meier estimates of the incidence', 'major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",6564.0,0.574825,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'E Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jaeger', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kittelson', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Gudz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Mátyás', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Dainis K', 'Initials': 'DK', 'LastName': 'Krievins', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lloyd P', 'Initials': 'LP', 'LastName': 'Haskell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}]",The New England journal of medicine,['10.1056/NEJMoa2000052']
302,31377837,Percutaneous reinforced osteoplasty for long bone metastases: a feasibility study.,"OBJECTIVE


While percutaneous osteoplasty is common for the treatment of vertebral fractures, low strength of fixation remains a major challenge for use in metastatic weight-bearing bones. With stent, wire, and cement augmentation, this study explores the feasibility of percutaneous reinforced osteoplasty for use in correcting long bone fractures.
MATERIALS AND METHODS


Fifteen explanted swine femora were randomly assigned into three groups. Group 1 (n = 5) was native (intact) bones without any intervention (control), group 2 (n = 5) received cementoplasty, and group 3 (n = 5) received stent and wire scaffolding (""rebar"") in addition to cementoplasty. All treatment procedures were performed under fluoroscopic guidance. Mechanical strength of fracture fixation was quantified by peak load to failure, stiffness, work done to fracture, and fatigue testing with four-point bend test.
RESULTS


Percutaneous osteoplasty with or without reinforcement was successfully achieved in all specimens. The respective peak load at failure, flexural stiffness, and work done to fracture (mean ± SEM) for group 1 was 2245 ± 168 N, 14.77 ± 1.3 Nm/degree, and 4854 ± 541 Nmm; group 2 was 468 ± 81 N, 3.9 ± 0.5 Nm/degree, and 401 ± 56 Nmm; and group 3 was 594 ± 90 N, 4.42 ± 0.4 Nm/degree, and 522 ± 54 Nmm. The mean cyclic displacement for groups 1, 2, and 3 were 0.15, 0.58, and 0.48 mm, respectively, at 220-240 N loading.
CONCLUSIONS


While percutaneous reinforced osteoplasty with stent, wire, and cement augmentation resulted in improved mechanical strength in restored bones, it did not differ significantly from specimens that underwent exclusive cementoplasty. With the improvement of fracture strength, the concept may be applicable for prevention or treatment of pathological fractures.",2020,"Mechanical strength of fracture fixation was quantified by peak load to failure, stiffness, work done to fracture, and fatigue testing with four-point bend test.
","['Fifteen explanted swine femora', 'group 1 was 2245\u2009±\u2009168\xa0N, 14.77\u2009±\u20091.3\xa0Nm/degree, and 4854\u2009±\u2009541 Nmm; group 2 was 468\u2009±\u200981\xa0N, 3.9\u2009±\u20090.5\xa0Nm/degree, and 401\u2009±\u200956 Nmm; and group 3 was 594\u2009±\u200990\xa0N, 4.42\u2009±\u20090.4\xa0Nm/degree, and 522\u2009±\u200954 Nmm']","['percutaneous reinforced osteoplasty', 'cementoplasty, and group 3 (n\u2009=\u20095) received stent and wire scaffolding (""rebar', 'Percutaneous reinforced osteoplasty', 'native (intact) bones without any intervention (control']","['mechanical strength', 'fracture strength', 'mean cyclic displacement', 'Mechanical strength of fracture fixation', 'respective peak load at failure, flexural stiffness, and work done to fracture (mean\u2009±\u2009SEM']","[{'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C4517762', 'cui_str': '4.42'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}, {'cui': 'C2938992', 'cui_str': 'Cementoplasty'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0016641', 'cui_str': 'Fracture Reduction'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439748', 'cui_str': 'Flexural (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",,0.0169491,"Mechanical strength of fracture fixation was quantified by peak load to failure, stiffness, work done to fracture, and fatigue testing with four-point bend test.
","[{'ForeName': 'Nischal', 'Initials': 'N', 'LastName': 'Koirala', 'Affiliation': 'Department of Chemical and Biomedical Engineering, Cleveland State University, 2121 Euclid Ave, Cleveland, OH, 44115, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'McLennan', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195, USA. mclenng@ccf.org.'}]",Skeletal radiology,['10.1007/s00256-019-03288-9']
303,31468342,Implementing Motivational Interviewing for Substance Misuse on Medical Inpatient Units: a Randomized Controlled Trial.,"BACKGROUND


General medical hospitals provide care for a disproportionate share of patients who misuse substances. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance misuse.
OBJECTIVE


To determine the effectiveness of three strategies for implementing motivational interviewing for substance misuse with general medical inpatients.
DESIGN


Type 3 hybrid effectiveness-implementation randomized controlled trial (Clinical Trials.gov: NCT01825057).
PARTICIPANTS


Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital.
INTERVENTIONS


Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition).
MAIN MEASURES


Primary outcomes were the percentage of study-eligible patients who received an interview for substance misuse and the integrity (adherence, competence) of the interviews. The secondary outcome was the percent of patient statements within the interviews that indicated motivation for reducing substance misuse.
KEY RESULTS


20.5% of patients in the consult condition received an interview, compared to 0.8% (Hedge's g = 1.49) and 3.0% (Hedge's g = 1.26) in the respective workshop only and apprenticeship conditions (p < 0.001). Motivational interviews in the consult condition were performed with more fundamental motivational interviewing adherence and competence than the other conditions. Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
CONCLUSIONS


Providers' ability to place an order to have experts from the consultation-liaison service deliver a motivational interview was a more effective implementation strategy than a workshop or apprenticeship method for ensuring motivational interviewing is available to medical inpatients who misuse substances.
TRIAL REGISTRY


NCT01825057.",2019,"Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
","['medical inpatients who misuse substances', 'substance misuse with general medical inpatients', 'Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital']","['implementing motivational interviewing', 'Implementing Motivational Interviewing', 'Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition']","['percent of patient statements within the interviews that indicated motivation for reducing substance misuse', 'interview for substance misuse and the integrity (adherence, competence) of the interviews']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013632', 'cui_str': 'Education, Medical, Continuing'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0369919', 'cui_str': 'Reducing substances (substance)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0448512,"Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions.
","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. steve.martino@yale.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zimbrean', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Forray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Joy S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Desan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Olmstead', 'Affiliation': 'Lyndon B. Johnson School of Public Affairs, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gilstad-Hayden', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Yonkers', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05257-3']
304,32215674,"Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial.","OBJECTIVE


This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis.
METHODS


The study included 104 patients (mean age 61.0 ± 6.2 years; range 50 to 70 years) who were admitted to our outpatient clinic with newly diagnosed with knee osteoarthritis. Patients were randomly assigned to two groups. Both groups received transcutaneous electrical nerve stimulation for 30 minutes, hot pack for 40 minutes, and home-based exercise program of around the knee strengthening for 30 minutes in a day for three weeks (5 days in a week). Also, one group was treated with r-ESWT, while the other group was treated with sham-ESWT. For r-ESWT, patients received 2000 pulses of shockwave at 2.0 to 3.0 bar weekly for three weeks. All patients were evaluated with visual analog scale (VAS), active knee range of motion (ROM), 20-metre walk test, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Lequesne's disability index, and isokinetic muscle performance before treatment, at the end of treatment, at one month and three months after treatment.
RESULTS


When groups were compared, group 1 scores were significantly better than the group 2 in all outcome parameters except WOMAC-stiffness at the end of treatment, at one month and three month follow-up (all p < 0.05). The VAS-resting, VAS-movement, knee ROM, 20-m walk test, WOMAC, and Lequesne's disability scores and peak torque values of knee extension improved in both groups with the highest improvement in the r-ESWT group. A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months.
CONCLUSION


Our findings revealed that r-ESWT combined with conventional electrotherapy is an effective treatment for improving pain and physical function in knee osteoarthritis to control symptoms up to three months.
CLINICAL TRIALS ID


NCT04243135.",2020,"A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months.
","['knee osteoarthritis', 'patients with knee osteoarthritis', '104 patients (mean age 61.0\u2009±\u20096.2\xa0years; range 50 to 70\xa0years) who were admitted to our outpatient clinic with newly diagnosed with knee osteoarthritis']","['radial extracorporeal shock wave therapy', 'sham-ESWT', 'transcutaneous electrical nerve stimulation for 30\xa0minutes, hot pack for 40\xa0minutes, and home-based exercise program of around the knee strengthening', 'r-ESWT treatment with sham-ESWT', 'conventional electrotherapy']","['clinical variables and isokinetic performance', 'pain, walking speed, physical function, and isokinetic muscle strength', ""visual analog scale (VAS), active knee range of motion (ROM), 20-metre walk test, Western Ontario and McMaster Osteoarthritis Index (WOMAC), Lequesne's disability index, and isokinetic muscle performance"", ""VAS-resting, VAS-movement, knee ROM, 20-m walk test, WOMAC, and Lequesne's disability scores and peak torque values of knee extension"", 'pain and physical function', 'WOMAC-stiffness']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",104.0,0.0386954,"A comparison of difference of the two group scores showed statistically significant superior improvement in group 1 in all parameters at both one month and three months.
","[{'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Uysal', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}, {'ForeName': 'Mustafa Turgut', 'Initials': 'MT', 'LastName': 'Yildizgoren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey. ftr.mustafaturgut@hotmail.com.'}, {'ForeName': 'Hayal', 'Initials': 'H', 'LastName': 'Guler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}, {'ForeName': 'Ayse Dicle', 'Initials': 'AD', 'LastName': 'Turhanoglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mustafa Kemal University Medical School, Hatay, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04541-w']
305,31051243,A Novel Approach to Tackling Bullying in Schools: Personality-Targeted Intervention for Adolescent Victims and Bullies in Australia.,"OBJECTIVE


To examine the secondary effects of a personality-targeted intervention on bullying and harms among adolescent victims and bullies.
METHOD


Outcomes were examined for victims and bullies in the Climate and Preventure study, Australia. Participants completed self-report measures at baseline and four follow-up assessments (6, 12, 24, and 36 months). Thirteen intervention schools (n = 1,087) received Preventure, a brief personality-targeted cognitive-behavioral therapy intervention for adolescents with high-risk personality types (hopelessness, anxiety sensitivity, impulsivity, sensation seeking). Thirteen control schools (n = 1,103) received health education as usual. Bullying was examined for high-risk victims (n = 143 in Preventure schools versus n = 153 in control schools) and bullies (n = 63 in Preventure schools versus n = 67 in control schools) in the total sample. Harms were examined for high-risk victims (n = 110 in Preventure schools versus n = 87 in control schools) and bullies (n = 50 in Preventure schools versus n = 30 in control schools) in independent schools.
RESULTS


There was no significant intervention effect for bullying victimization or perpetration in the total sample. In the subsample, mixed models showed greater reductions in victimization (b = -0.208, 95% CI -0.4104 to -0.002, p < .05), suicidal ideation (b = -0.130, 95% CI -0.225 to -0.034, p < .01), and emotional symptoms (b = -0.263, 95% CI -0.466 to -0.061, p < .05) among high-risk victims in Preventure versus control schools. Conduct problems (b = -0.292, 95% CI -0.554 to -0.030, p < .05) showed greater reductions among high-risk bullies in Preventure versus control schools, and suicidal ideation showed greater reductions among high-risk female bullies in Preventure versus control schools (b = -0.820, 95% CI -1.198 to -0.442, p < .001).
CONCLUSION


The findings support targeting personality in bullying prevention.
CLINICAL TRIAL REGISTRATION INFORMATION


The CAP Study: Evaluating a Comprehensive Universal and Targeted Intervention Designed to Prevent Substance Use and Related Harms in Australian Adolescents; http://www.anzctr.org.au/; ACTRN12612000026820.",2020,"In the subsample, mixed models showed greater reductions in victimization (b = -0.208, 95% CI -0.4104 to -0.002, p < .05), suicidal ideation (","['adolescent victims and bullies', 'Thirteen control schools (n\xa0= 1,103) received', 'n\xa0= 87 in control schools) and bullies (n\xa0= 50 in Preventure schools versus', 'Adolescent Victims and Bullies in Australia', 'adolescents with high-risk personality types (hopelessness, anxiety sensitivity, impulsivity, sensation seeking', 'n\xa0= 153 in control schools) and bullies (n\xa0= 63 in Preventure schools versus', 'Outcomes were examined for victims and bullies in the Climate and Preventure study, Australia', 'n\xa0= 30 in control schools) in independent schools', 'Thirteen intervention schools (n\xa0= 1,087) received', 'n\xa0= 67 in control schools) in the total sample']","['Preventure, a brief personality-targeted cognitive-behavioral therapy intervention', 'personality-targeted intervention', 'health education as usual']","['emotional symptoms', 'suicidal ideation ', 'victimization']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0332128', 'cui_str': 'Examined for (contextual qualifier) (qualifier value)'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0018701'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",1103.0,0.0494639,"In the subsample, mixed models showed greater reductions in victimization (b = -0.208, 95% CI -0.4104 to -0.002, p < .05), suicidal ideation (","[{'ForeName': 'Erin V', 'Initials': 'EV', 'LastName': 'Kelly', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, Sydney Medical School, Medicine and Health, The University of Sydney, Australia, and the NHMRC Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia; Centre de Recherche, Centre Hospitalier Ste-Justine, Montreal, Quebec, Canada. Electronic address: erin.k@sydney.edu.au.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, Sydney Medical School, Medicine and Health, The University of Sydney, Australia, and the NHMRC Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lexine A', 'Initials': 'LA', 'LastName': 'Stapinski', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, Sydney Medical School, Medicine and Health, The University of Sydney, Australia, and the NHMRC Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Conrod', 'Affiliation': 'University of Montreal, Quebec, Canada.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Barrett', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, Sydney Medical School, Medicine and Health, The University of Sydney, Australia, and the NHMRC Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, Sydney Medical School, Medicine and Health, The University of Sydney, Australia, and the NHMRC Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, Sydney Medical School, Medicine and Health, The University of Sydney, Australia, and the NHMRC Centre for Research Excellence in Mental Health and Substance Use, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.04.010']
306,32215834,The effects of caffeine on drowsiness in patients with narcolepsy: a double-blind randomized controlled pilot study.,"PURPOSE


The effects of caffeine on drowsiness and reaction time in patients with narcolepsy are unclear. We aimed to assess the effects of caffeine as add-on therapy in narcolepsy patients.
METHODS


A randomized, double-blind, placebo-control clinical pilot trial was conducted with a parallel, two-arm trial allocation ratio of 1:1. Participants attended two study visits 7 days apart. The drug was administered orally in a single opaque capsule containing 200 mg caffeine/placebo daily in the morning for 1 week. Sleepiness was assessed objectively using infrared reflectance oculography to measure the percentage of long eye closure (LEC%) and subjectively using two sleepiness scales, the Stanford Sleepiness Scale (SSS) and Karolinska Sleepiness Scale (KSS). Parameters were measured at baseline (BL) prior to taking the drug, after taking the first dose (FD), and after 1 week (WD) of daily caffeine.
RESULTS


Sixteen participants with narcolepsy were included. No significant differences between groups in baseline measurements were observed. LEC% was significantly decreased after the FD and WD compared with baseline levels (BL 1.4 ± 2.1 vs. FD 0.06 ± 0.0.6 and WD 0.03 ± 0.04). Significant improvements in alertness were observed using the KSS when comparing BL with FD and WD (6.3 ± 1.6, 4.9 ± 1.7, and 4.7 ± 1.7, respectively; p = 0.01). No changes in reaction time or SSS scores were noted.
CONCLUSION


Our findings suggest that a small dose of caffeine has positive effects on alertness in patients with narcolepsy. However, larger trials are required to confirm these findings.
TRIAL REGISTRATION NO


ClinicalTrial.gov NCT02832336.",2020,LEC% was significantly decreased after the FD and WD compared with baseline levels (BL 1.4 ± 2.1 vs. FD 0.06 ± 0.0.6 and WD 0.03 ± 0.04).,"['Sixteen participants with narcolepsy were included', 'patients with narcolepsy', 'patients with narcolepsy are unclear', 'narcolepsy patients']","['caffeine', 'caffeine/placebo', 'placebo']","['drowsiness', 'LEC', 'alertness', 'Sleepiness', 'drowsiness and reaction time', 'percentage of long eye closure (LEC%) and subjectively using two sleepiness scales, the Stanford Sleepiness Scale (SSS) and Karolinska Sleepiness Scale (KSS', 'reaction time or SSS scores']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1269837', 'cui_str': 'Surgical closure of eye structure'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",16.0,0.472743,LEC% was significantly decreased after the FD and WD compared with baseline levels (BL 1.4 ± 2.1 vs. FD 0.06 ± 0.0.6 and WD 0.03 ± 0.04).,"[{'ForeName': 'Mona S', 'Initials': 'MS', 'LastName': 'Aldosari', 'Affiliation': 'Clinical Nutrition Department, King Khalid University Hospital, King Saud University Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Awad H', 'Initials': 'AH', 'LastName': 'Olaish', 'Affiliation': 'Department of Medicine, College of Medicine, University Sleep Disorders Center, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Samar Z', 'Initials': 'SZ', 'LastName': 'Nashwan', 'Affiliation': 'Department of Medicine, College of Medicine, University Sleep Disorders Center, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mahmoud M A', 'Initials': 'MMA', 'LastName': 'Abulmeaty', 'Affiliation': 'Clinical Nutrition Program, Community Health Sciences, King Saud University, Riyadh, Saudi Arabia. dr.abulmeaty@gmail.com.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'BaHammam', 'Affiliation': 'Department of Medicine, College of Medicine, University Sleep Disorders Center, King Saud University, Riyadh, Saudi Arabia. ashammam2@gmail.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02065-6']
307,30851397,Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions.,"OBJECTIVE


Treatment for childhood anxiety disorders is insufficient in many cases. Parent involvement has been examined to augment child-based cognitive-behavioral therapy (CBT), but no studies have compared the efficacy of stand-alone parent-based treatment to CBT. Research implicates family accommodation in the maintenance and course of childhood anxiety. Supportive Parenting for Anxious Childhood Emotions (SPACE) is a parent-based treatment that reduces accommodation of childhood anxiety. This study compared SPACE to CBT in a noninferiority trial.
METHOD


Participants were children with primary anxiety disorders (N = 124; 7-14 years of age; 53% female participants; 83% white), randomly assigned to either SPACE (n = 64) with no direct child-therapist contact, or CBT (n = 60) with no parent treatment. A total of 97 participants (78%) completed all treatment sessions and assessments. Attrition did not differ significantly between groups. Primary anxiety outcomes included diagnostic interview and clinician-rated scales. Secondary outcomes included parent and child ratings of anxiety severity, family accommodation, and parenting stress. Noninferiority margins were determined based on statistical and clinical considerations. Change in family accommodation and parenting stress were examined using mixed models analyses.
RESULTS


SPACE was noninferior, relative to CBT, on primary and secondary anxiety outcomes, and based on ratings provided by independent evaluators, parents, and children. Family accommodation and parenting stress were significantly reduced in both treatments, with significantly greater reduction in family accommodation following SPACE compared to CBT. Treatment credibility and satisfaction were high.
CONCLUSION


SPACE is an acceptable and efficacious treatment for childhood anxiety disorders, is noninferior to CBT, and provides an alternative strategy for treating anxiety in children.
CLINICAL TRIAL REGISTRATION INFORMATION


Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE); https://clinicaltrials.gov; NCT02310152.",2020,"Family accommodation and parenting stress were significantly reduced in both treatments, with significantly greater reduction in family accommodation following SPACE compared to CBT.","['children', 'Participants were children with primary anxiety disorders (N\xa0= 124; 7-14 years of age; 53% female participants; 83% white', 'Anxious Childhood Emotions', 'n\xa0= 64) with no direct child-therapist contact, or CBT (n\xa0= 60) with no parent treatment', 'Childhood Anxiety', 'childhood anxiety disorders']","['SPACE', 'Supportive Parenting']","['diagnostic interview and clinician-rated scales', 'Attrition', 'Change in family accommodation and parenting stress', 'Family accommodation and parenting stress', 'parent and child ratings of anxiety severity, family accommodation, and parenting stress']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",97.0,0.0334477,"Family accommodation and parenting stress were significantly reduced in both treatments, with significantly greater reduction in family accommodation following SPACE compared to CBT.","[{'ForeName': 'Eli R', 'Initials': 'ER', 'LastName': 'Lebowitz', 'Affiliation': 'Yale University Child Study Center, New Haven, CT. Electronic address: eli.lebowitz@yale.edu.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Marin', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Martino', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Shimshoni', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.02.014']
308,32000798,"Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries.","BACKGROUND


Oligohydramnios is a condition of abnormally low amniotic fluid volume that has been associated with poor pregnancy outcomes. To date, the prevalence of this condition and its outcomes has not been well described in low and low-middle income countries (LMIC) where ultrasound use to diagnose this condition in pregnancy is limited. As part of a prospective trial of ultrasound at antenatal care in LMICs, we sought to evaluate the incidence of and the adverse maternal, fetal and neonatal outcomes associated with oligohydramnios.
METHODS


We included data in this report from all pregnant women in community settings in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo (DRC) who received a third trimester ultrasound as part of the First Look Study, a randomized trial to assess the value of ultrasound at antenatal care. Using these data, we conducted a planned secondary analysis to compare pregnancy outcomes of women with to those without oligohydramnios. Oligohydramnios was defined as measurement of an Amniotic Fluid Index less than 5 cm in at least one ultrasound in the third trimester. The outcomes assessed included maternal morbidity and fetal and neonatal mortality, preterm birth and low-birthweight. We used pairwise site comparisons with Tukey-Kramer adjustment and multivariable logistic models using general estimating equations to account for the correlation of outcomes within cluster.
RESULTS


Of 12,940 women enrolled in the clusters in Guatemala, Pakistan, Zambia and the DRC in the First Look Study who had a third trimester ultrasound examination, 87 women were diagnosed with oligohydramnios, equivalent to 0.7% of those studied. Prevalence of detected oligohydramnios varied among study sites; from the lowest of 0.2% in Zambia and the DRC to the highest of 1.5% in Pakistan. Women diagnosed with oligohydramnios had higher rates of hemorrhage, fetal malposition, and cesarean delivery than women without oligohydramnios. We also found unfavorable fetal and neonatal outcomes associated with oligohydramnios including stillbirths (OR 5.16, 95%CI 2.07, 12.85), neonatal deaths < 28 days (OR 3.18, 95% CI 1.18, 8.57), low birth weight (OR 2.10, 95% CI 1.44, 3.07) and preterm births (OR 2.73, 95%CI 1.76, 4.23). The mean birth weight was 162 g less (95% CI -288.6, - 35.9) with oligohydramnios.
CONCLUSIONS


Oligohydramnos was associated with worse neonatal, fetal and maternal outcomes in LMIC. Further research is needed to assess effective interventions to diagnose and ultimately to reduce poor outcomes in these settings.
TRIAL REGISTRATION


NCT01990625.",2020,"Women diagnosed with oligohydramnios had higher rates of hemorrhage, fetal malposition, and cesarean delivery than women without oligohydramnios.","['12,940 women enrolled in the clusters in Guatemala, Pakistan, Zambia and the DRC in the First Look Study who had a third trimester ultrasound examination, 87 women were diagnosed with oligohydramnios, equivalent to 0.7% of those studied', 'pregnant women in community settings in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo (DRC) who received a third trimester ultrasound as part of the First Look Study', 'women with to those without oligohydramnios', 'low-middle income countries']",[],"['neonatal deaths', 'rates of hemorrhage, fetal malposition, and cesarean delivery', 'mean birth weight', 'Prevalence of detected oligohydramnios', 'low birth weight', 'Oligohydramnios', 'maternal morbidity and fetal and neonatal mortality, preterm birth and low-birthweight', 'preterm births']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]",[],"[{'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0269699', 'cui_str': 'Finding of malposition of fetus'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0079924', 'cui_str': 'Oligohydramnios'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",12940.0,0.211981,"Women diagnosed with oligohydramnios had higher rates of hemorrhage, fetal malposition, and cesarean delivery than women without oligohydramnios.","[{'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Instituto de Nutrición de Centro América y Panamá (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'Social Statistical and Environmental Health Sciences, RTI International, Durham, NC, USA. mcclure@rti.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': 'Department of Radiology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Department of Radiology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Garces', 'Affiliation': 'Instituto de Nutrición de Centro América y Panamá (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Moore', 'Affiliation': 'Social Statistical and Environmental Health Sciences, RTI International, Durham, NC, USA.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bauserman', 'Affiliation': 'Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Waseem', 'Initials': 'W', 'LastName': 'Mirza', 'Affiliation': 'Department of Radiology, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Naqvi', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'Department of Pediatrics, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Department of Pediatrics, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'School of Medicine, Moi University, Eldoret, Kenya.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Swanson', 'Affiliation': 'Department of Radiology, Harborview Medical Center, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Department of Obstetrics/Gynecology, Columbia University, New York, NY, USA.'}]",Reproductive health,['10.1186/s12978-020-0854-y']
309,31090968,"Rural Clients' Continuity Into Follow-Up Substance Use Disorder Treatment: Impacts of Travel Time, Incentives, and Alerts.","PURPOSE


Treatment after discharge from detoxification or residential treatment is associated with improved outcomes. We examined the influence of travel time on continuity into follow-up treatment and whether financial incentives and weekly alerts have a modifying effect.
METHODS


For a research intervention during October 2013 to December 2015, detoxification and residential substance use disorder treatment programs in Washington State were randomized into 4 groups: potential financial incentives for meeting performance goals, weekly alerts to providers, both interventions, and control. Travel time was used as both a main effect and interacted with other variables to explore its modifying impact on continuity of care in conjunction with incentives or alerts. Continuity was defined as follow-up care occurring within 14 days of discharge from detoxification or residential treatment programs. Travel time was estimated as driving time from clients' home ZIP Code to treatment agency ZIP Code.
FINDINGS


Travel times to the original treatment agency were in some cases significant with longer travel times predicting lower likelihood of continuity. For detoxification clients, those with longer travel times (over 91 minutes from their residence) are more likely to have timely continuity. Conversely, residential clients with travel times of more than 1 hour are less likely to have timely continuity. Interventions such as alerts or incentives for performance had some mitigating effects on these results. Travel times to the closest agency for potential further treatment were not significant.
CONCLUSIONS


Among rural clients discharged from detoxification and residential treatment, travel time can be an important factor in predicting timely continuity.",2020,"Travel times to the closest agency for potential further treatment were not significant.
","['For a research intervention during October 2013 to December 2015', 'rural clients', 'detoxification and residential substance use disorder treatment programs in Washington State']",[],['Travel time'],"[{'cui': 'C0035168'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0261109,"Travel times to the closest agency for potential further treatment were not significant.
","[{'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Garnick', 'Affiliation': 'The Heller School for Social Policy and Management, Institute for Behavioral Health, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Horgan', 'Affiliation': 'The Heller School for Social Policy and Management, Institute for Behavioral Health, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Acevedo', 'Affiliation': 'Department of Community Health, Tufts University, Medford, Massachusetts.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Lee', 'Affiliation': 'The Heller School for Social Policy and Management, Institute for Behavioral Health, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Panas', 'Affiliation': 'The Heller School for Social Policy and Management, Institute for Behavioral Health, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Ritter', 'Affiliation': 'The Heller School for Social Policy and Management, Institute for Behavioral Health, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Research and Data Analysis, Washington State Department of Social and Health Services, Olympia, Washington.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12375']
310,32209529,Help to Overcome Problems Effectively for Cancer Survivors: Development and Evaluation of a Digital Self-Management Program.,"BACKGROUND


People living with cancer face numerous psychosocial challenges, including cancer-related fatigue, fear of recurrence, and depression. There is a lack of digital interventions tailored to the needs of people living with all types of cancer. We developed a 6-week, digital, peer-delivered, self-management program: iHOPE (Help to Overcome Problems Effectively; where 'i' indicates the digital version of the program). The program is underpinned by positive psychology and cognitive behavioral therapy to meet these psychosocial challenges.
OBJECTIVE


This study aimed to assess the feasibility of the iHOPE program among people living with cancer. Program adherence and satisfaction along with changes in psychological distress and positive well-being were measured.
METHODS


A pre-post, acceptability, and feasibility design was used. People living with cancer (N=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE program. Demographic and other participant characteristics were recorded. Participants completed digital measures at baseline and the end of the 6-week program for depression, anxiety, cancer-related fatigue, cancer worry or fear of cancer recurrence, positive mental well-being, hope, gratitude, and health status. The website's system recorded data on the usage of the program. Satisfaction with the program was also measured.
RESULTS


A total of 114 participants completed the baseline questionnaires. Of these, 70 people (61.4%) participated in all 6 sessions. The mean number of sessions undertaken was 5.0 (SD 1.5). Moreover, 44.7% (51/114) of participants completed at least three sessions and end-of-program outcome measures. A total of 59 participants completed the satisfaction questionnaire, where ≥90% (54/58) of participants reported that the program was easy to navigate and was well managed by the peer facilitators, and that they found the social networking tools useful. Preliminary efficacy testing among the 51 participants who completed baseline and postprogram outcome measures showed that postprogram scores decreased for depression, anxiety, cancer-related fatigue, and fear of recurrence (all P<.001) and increased for positive mental well-being (P<.001), hope (both P<.001), and gratitude (P=.02).
CONCLUSIONS


The feasibility evidence is promising, showing that the peer-delivered digital iHOPE program is acceptable and practical. Implementation of the iHOPE program on a wider scale will incorporate further research and development to maximize the completion rates of the measures. Initial effectiveness data suggest positive impacts on important cancer-related quality of life and mental well-being outcomes. A randomized controlled trial design with a longer follow-up is needed to confirm the potential of the iHOPE program for improving mental and physical health outcomes for cancer survivors.",2020,"Preliminary efficacy testing among the 51 participants who completed baseline and post-programme outcome measures showed that post-programme scores decreased for depression, anxiety, cancer related fatigue and fear of recurrence (all P<.001) and increased for positive mental wellbeing, hope (both P<.001) and gratitude (P=0.015).
","['cancer survivors', 'Cancer Survivors', 'Seventy people (61%) participated in all six sessions', 'people living with cancer', 'People living with cancer (n=114) were recruited via a national cancer charity in the United Kingdom and were given access to the iHOPE programme', 'One hundred and fourteen participants completed baseline questionnaires']",['iHOPE programme'],"['depression, anxiety, cancer-related fatigue, cancer ""worry"" or fear of cancer recurrence, positive mental wellbeing, hope, gratitude and health status', 'important cancer-related quality of life and mental wellbeing outcomes', 'satisfaction questionnaire', 'psychological distress and positive wellbeing', 'depression, anxiety, cancer related fatigue and fear of recurrence', 'mean number of sessions undertaken', 'positive mental wellbeing, hope (both P<.001) and gratitude']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]",114.0,0.12117,"Preliminary efficacy testing among the 51 participants who completed baseline and post-programme outcome measures showed that post-programme scores decreased for depression, anxiety, cancer related fatigue and fear of recurrence (all P<.001) and increased for positive mental wellbeing, hope (both P<.001) and gratitude (P=0.015).
","[{'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Faculty of Health and Applied Science, University of the West of England, Bristol, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Wright', 'Affiliation': 'Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Moody', 'Affiliation': 'Faculty Research Centre for Arts, Memory and Communities, Faculty of Arts and Humanities, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Whiteman', 'Affiliation': 'UK Early Cancer Detection Consortium, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Clyne', 'Affiliation': 'Hope for The Community, Community Interest Company, The Enterprise Hub, Coventry, United Kingdom.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Pearce', 'Affiliation': 'Faculty of Health and Life Sciences, School of Psychological, Social and Behavioural Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Faculty Research Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17824']
311,32211798,Circulating Insulin-Like Growth Factor-1 Is Positively Associated with Growth and Cognition in 6- to 9-Year-Old Schoolchildren from Ghana.,"BACKGROUND


Milk intake stimulates linear growth and improves cognition in children from low-income countries. These effects may be mediated through insulin-like growth factor-1 (IGF-1).
OBJECTIVE


The objective was to assess the effect of milk supplement on circulating IGF-1 and to assess IGF-1 as a correlate of growth and cognition in children.
METHODS


Secondary data on blood spot IGF-1 from a randomized, double-blind, controlled trial in 6-9-y-old children from rural Ghana were analyzed. Intervention groups received porridge with non-energy-balanced supplements: 8.8 g milk protein/d, 100 kcal/d (Milk8); 4.4 g milk and 4.4 g rice protein/d, 100 kcal/d (Milk/rice); 4.4 g milk protein/d, 48 kcal/d (Milk4); or a control (no protein, 10 kcal/d). IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB) were measured at 3.5 or 8.5 mo. Linear regressions were used to assess the effect of milk interventions on IGF-1 and IGF-1 as a correlate of growth and cognition.
RESULTS


The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3) ng/mL higher in children receiving Milk8 compared with the control. The IGF-1 increases in the isonitrogenous, isoenergetic Milk/rice or the Milk4 groups were not different from the control (P ≥ 0.49). The increase in IGF-1 was associated with improvements in 4 out of 5 CANTAB domains. The strongest associations included reductions in ""mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra/Extradimensional Set Shift (P ≤ 0.005). In addition, change in IGF-1 was positively associated with changes in height, weight, and fat-free mass (P ≤ 0.001).
CONCLUSIONS


Intake of skimmed milk powder corresponding to one, but not half a glass of milk on school days stimulates IGF-1 in 6-9-y-old Ghanian children. IGF-1 seems to mediate the effect of milk intake on growth and cognition. The association between IGF-1 and cognition in relation to milk intake is novel and opens possibilities for dietary interventions to improve cognition.",2020,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","['6-9-y-old children from rural Ghana were analyzed', 'children', 'children from low-income countries']","['porridge with non-energy-balanced supplements: 8.8\xa0g milk protein', 'milk supplement']","['change in IGF-1', 'IGF-1, length, body composition, and Cambridge Neuropsychological Test Automated Battery (CANTAB', 'IGF-1', 'IGF-1 increases', 'Circulating Insulin-Like Growth Factor-1', 'mean correct latency"" from Pattern Recognition Memory and ""pre-extradimensional (pre-ED) shift errors"" from Intra', 'Growth and Cognition', 'blood spot IGF-1', 'height, weight, and fat-free mass']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0026138', 'cui_str': 'Milk Proteins'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}]",,0.0402681,"The increase in IGF-1 was 15.3 (95% CI: 3.3, 27.3)","[{'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Larnkjær', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Serena', 'Affiliation': 'Global Nutrition, Arla Foods amba, Skejby, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Manary', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, MO, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa075']
312,32211803,"Spices in a High-Saturated-Fat, High-Carbohydrate Meal Reduce Postprandial Proinflammatory Cytokine Secretion in Men with Overweight or Obesity: A 3-Period, Crossover, Randomized Controlled Trial.","BACKGROUND


Postprandial inflammation that occurs concurrently with hyperglycemia and hyperlipidemia after ingestion of a high-saturated-fat, high-carbohydrate meal (HFCM) is a risk factor for cardiovascular disease (CVD). Numerous preclinical and clinical studies demonstrate anti-inflammatory effects of individual spices. However, the effect of consumption of a spice blend on inflammatory mediators has not been examined in a randomized controlled trial.
OBJECTIVES


The objective of this study was to investigate the postprandial effect of a blend of spices in a HFCM on inflammatory cytokine responses.
METHODS


Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35 kg/m2), elevated waist circumference (≥ 94 cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n = 12). In random order, participants consumed the following: a HFCM (∼1000 kcal, 33% kcal from saturated fat and 36% kcal from carbohydrate), a HFCM containing 2 g spice blend, or an HFCM containing 6 g spice blend. The spice blend consisted of basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric. Blood was collected before, and hourly for 4 h after the HFCM. Peripheral blood mononuclear cells (PBMCs) were isolated, and the percentage of CD14 +/Human Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations in plasma and LPS-stimulated PBMCs were quantified as secondary outcomes.
RESULTS


There was a significant spice-by-time interaction on IL-1β (P < 0.001), IL-8 (P = 0.020), and TNF-α (P = 0.009) secretion from LPS-stimulated PBMCs. IL-1β secretion from LPS-stimulated PBMCs was significantly reduced (1314%) at 240 min after HFCM consumption containing 6 g, but not 2 g, of spice blend compared with 0 g spice blend.
CONCLUSIONS


A HFCM containing 6 g spice blend attenuated HFCM-induced postprandial IL-1β secretion in men with overweight/obesity.This trial was registered at clinicaltrials.gov as NCT03064958.",2020,There was a significant spice-by-time interaction on IL-1β,"['Men with Overweight or Obesity', 'men with overweight/obesity', 'Nonsmoking men (40-65 y old) with overweight/obesity (25 ≤ BMI ≤ 35\xa0kg/m2), elevated waist circumference (≥ 94\xa0cm), and ≥ 1 CVD risk factor were recruited for a 3-period crossover study ( n\xa0=\xa012']","['HFCM', 'carbohydrate meal (HFCM', 'High-Saturated-Fat, High-Carbohydrate Meal', 'HFCM containing 2\xa0g spice blend, or an HFCM containing 6\xa0g spice blend', 'basil, bay leaf, black pepper, cinnamon, coriander, cumin, ginger, oregano, parsley, red pepper, rosemary, thyme, and turmeric', 'HFCM (∼1000\xa0kcal, 33%\xa0kcal from saturated fat and 36%\xa0kcal from carbohydrate']","['IL-8', 'TNF-α', 'IL-1β secretion from LPS-stimulated PBMCs', 'Postprandial Proinflammatory Cytokine Secretion', 'percentage of CD14 +/Human', 'Peripheral blood mononuclear cells (PBMCs', 'IL-1β', 'postprandial IL-1β secretion', 'Leukocyte Antigen-DR isotype + (HLA-DR +) monocytes and proinflammatory cytokine concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037910', 'cui_str': 'Spices'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0600402', 'cui_str': 'Basil'}, {'cui': 'C0453244', 'cui_str': 'Bay Leaf'}, {'cui': 'C0162750', 'cui_str': 'Black Pepper'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C0162747', 'cui_str': 'Coriander'}, {'cui': 'C0524875', 'cui_str': 'Cumin'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0453263', 'cui_str': 'Oregano'}, {'cui': 'C0994493', 'cui_str': 'Parsley'}, {'cui': 'C0446306', 'cui_str': 'Bell Pepper'}, {'cui': 'C1262899', 'cui_str': 'Rosemary (substance)'}, {'cui': 'C1305848', 'cui_str': 'Thyme'}, {'cui': 'C0041356', 'cui_str': 'Tumeric'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0907223,There was a significant spice-by-time interaction on IL-1β,"[{'ForeName': 'Ester S', 'Initials': 'ES', 'LastName': 'Oh', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Kristina S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Connie J', 'Initials': 'CJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa063']
313,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
314,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
315,30732732,Pulmonary Artery Denervation Significantly Increases 6-Min Walk Distance for Patients With Combined Pre- and Post-Capillary Pulmonary Hypertension Associated With Left Heart Failure: The PADN-5 Study.,"OBJECTIVES


The authors sought to assess the benefits of pulmonary artery denervation (PADN) among combined pre- and post-capillary pulmonary hypertension (CpcPH) patients in a prospective, randomized, sham-controlled trial.
BACKGROUND


PADN has been shown to improve hemodynamics of pulmonary arterial hypertension in a series of patients. Additionally, benefits of targeted medical therapy for patients with CpcPH secondary to left-sided heart failure are unknown.
METHODS


Ninety-eight CpcPH patients, defined as mean pulmonary arterial pressure ≥25 mm Hg, pulmonary capillary wedge pressure >15 mm Hg, and pulmonary vascular resistance (PVR) >3.0 Wood units (WU), were randomly assigned to PADN or sildenafil plus sham PADN. Standard medical therapy for heart failure was administered to all patients in both groups. The primary endpoint was the increase in the 6-min walk distance at the 6-month follow-up. The secondary endpoint was change in PVR. Clinical worsening was assessed in a post hoc analysis. The main safety endpoint was occurrence of pulmonary embolism.
RESULTS


At 6 months, the mean increases in the 6-min walk distance were 83 m in the PADN group and 15 m in the sildenafil group (least square mean difference 66 m, 95% confidence interval: 38.2 to 98.8 m; p < 0.001). PADN treatment was associated with a significantly lower PVR than in the sildenafil group (4.2 ± 1.5 WU vs. 6.1 ± 2.9 WU; p = 0.001). Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014). At the end of the study, there were 7 all-cause deaths and 2 cases of pulmonary embolism.
CONCLUSIONS


PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH. Further studies are warranted to define its precise role in the treatment of this patient population. (Pulmonary Arterial Denervation in Patients With Pulmonary Hypertension Associated With the Left Heart Failure [PADN-5]; NCT02220335).",2019,Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014).,"['patients with CpcPH secondary to left-sided heart failure', 'Failure', 'Patients With Pulmonary Hypertension', 'Ninety-eight', 'Patients With Combined Pre- and', 'patients with CpcPH']","['combined pre- and post-capillary pulmonary hypertension (CpcPH', 'sildenafil', 'PADN or sildenafil plus sham PADN', 'pulmonary artery denervation (PADN', 'CpcPH']","['Hg, pulmonary capillary wedge pressure', '6-min walk distance', 'pulmonary embolism', '6-Min Walk Distance', 'change in PVR', 'mean pulmonary arterial pressure', 'hemodynamic and clinical outcomes', 'pulmonary vascular resistance (PVR', 'occurrence of pulmonary embolism', 'mean increases in the 6-min walk distance', 'PVR', 'Clinical worsening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0023212', 'cui_str': 'Left-Sided Heart Failure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1283386', 'cui_str': 'Post-capillary pulmonary hypertension (disorder)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary Artery'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}]","[{'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",98.0,0.113782,Clinical worsening was less frequent in the PADN group compared with the sildenafil group (16.7% vs. 40%; p = 0.014).,"[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Mengxuan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Mailman School of Health, Columbia University, New York, New York.'}, {'ForeName': 'Du-Jiang', 'Initials': 'DJ', 'LastName': 'Xie', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wande', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Li', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Division of Cardiology, Nanjing Cardiovascular Hospital, Nanjing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianzeng', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Division of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Division of Pulmonology, Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Shenyang Northern Hospital, Shenyang, China.'}, {'ForeName': 'Shao-Liang', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2018.09.021']
316,32209825,Community Health Workers Reduce Rehospitalizations and Emergency Department Visits for Low-Socioeconomic Urban Patients With Heart Failure.,"BACKGROUND


Low-socioeconomic, urban, minority patients with heart failure (HF) often have unique barriers to care. Community health workers (CHWs) are specially trained laypeople who serve as liaisons between underserved communities and the health system. It is not known whether CHWs improve outcomes in low-socioeconomic, urban, minority patients with HF.
HYPOTHESIS


CHWs reduce rehospitalizations, emergency department (ED) visits, and healthcare costs for low-socioeconomic urban patients with HF.
METHODS


Patients admitted with acute decompensated HF were assigned to receive weekly visits by CHW after discharge. Patients were propensity score matched with controls who received usual care. HF-related rehospitalizations, ED visits, and inpatient costs were compared for 12 months following index admission versus the same period before.
RESULTS


Twenty-eight patients who received weekly visits from a CHW for 12 months after discharge were matched with 28 control patients who did not receive CHWs. Patients who received a CHW had a 75% decrease in HF-related ED visits (0.71 vs. 0.18 visits per patient, P < 0.001), an 89% decrease in HF-related readmissions (0.64 vs. 0.07 admissions per patient, P < 0.005), and a significant decrease in inpatient cost for HF-related visits. In controls receiving usual care, there was no significant change in hospitalizations, ED visits, or costs.
CONCLUSIONS


In conclusion, CHWs are associated with reduced rehospitalizations, ED visits, and inpatient costs in low-socioeconomic, urban, minority patients with HF. CHWs may be a cost-effective method to reduce health care utilization and improve outcomes for this population.",2020,"In controls receiving usual care, there was no significant change in hospitalizations, ED visits, or costs.
","['Community health workers (CHW) are specially trained lay-people who serve as liaisons between underserved communities and the health system', 'Patients were propensity-score matched with controls who received usual care', 'Low-Socioeconomic Urban Patients with Heart Failure', 'minority patients with heart failure (HF', 'low-socioeconomic, urban, minority patients with HF', 'Patients admitted with acute decompensated HF', 'low-socioeconomic urban patients with heart failure (HF', 'Twenty-eight patients who received weekly visits from a CHW for 12 months after discharge were matched with 28 control patients who did not receive CHWs']","['CHWs', 'CHW']","['rehospitalizations, emergency department (ED) visits, and healthcare costs', 'reduced rehospitalizations, ED visits, and inpatient costs', 'HF-related readmissions', 'hospitalizations, ED visits, or costs', 'inpatient cost for HF-related visits', 'HF-related rehospitalizations, ED visits, and inpatient costs', 'HF-related ED visits']","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]",[],"[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",28.0,0.0287021,"In controls receiving usual care, there was no significant change in hospitalizations, ED visits, or costs.
","[{'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Vohra', 'Affiliation': 'From the Department of Medicine, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Rhys F M', 'Initials': 'RFM', 'LastName': 'Chua', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Besser', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Charina F', 'Initials': 'CF', 'LastName': 'Alcain', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Basnet', 'Affiliation': 'Urban Health Initiative, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Battle', 'Affiliation': 'Urban Health Initiative, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Coplan', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Liao', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}, {'ForeName': 'Corey E', 'Initials': 'CE', 'LastName': 'Tabit', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago, Chicago, IL, and.'}]",Critical pathways in cardiology,['10.1097/HPC.0000000000000220']
317,31484786,Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial.,"INTRODUCTION


Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.
METHODS


Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO 2 ) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.
RESULTS


Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO 2  change home vs in-hospital: 0.04 kPa (95% CI -0.31 to 0.38 kPa), with both groups showing a PaCO 2  reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546-€4163) vs in-hospital: median €8537 (IQR €7540-€9175); p<0.001).
DISCUSSION


This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.
TRIAL REGISTRATION NUMBER


NCT02652559.",2020,"In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)).","['Sixty-seven stable hypercapnic COPD patients', 'stable hypercapnic COPD patients', 'COPD patients with chronic hypercapnic respiratory failure']","['telemedicine', 'chronic non-invasive ventilation', 'Chronic non-invasive ventilation (NIV']","['daytime arterial carbon dioxide pressure (PaCO 2 ) reduction', 'health-related quality of life (HRQoL) and costs', 'Clinical COPD Questionnaire total score']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960052', 'cui_str': 'Chronic type II respiratory failure'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",67.0,0.274177,"In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)).","[{'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'Duiverman', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands m.l.duiverman@umcg.nl.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Vonk', 'Affiliation': 'Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gerrie', 'Initials': 'G', 'LastName': 'Bladder', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Joost P', 'Initials': 'JP', 'LastName': 'van Melle', 'Affiliation': 'Thoraxcenter, Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jellie', 'Initials': 'J', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anda', 'Initials': 'A', 'LastName': 'Hazenberg', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Job F M', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Wijkstra', 'Affiliation': 'Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Thorax,['10.1136/thoraxjnl-2019-213303']
318,32401099,Internet-based therapy with FearFighter for anxiety disorders: a randomised clinical trial.,"Background:  Internet-based cognitive behavioural self-help psychotherapy (ICBT) can be an important alternative or supplement to ordinary face-to-face therapy. Aim:  To assess effectiveness of ICBT for adults with an anxiety disorder. Methods:  Sixty-four participants were randomised to 9 weeks with the FearFighter ICBT program ( n  = 32) or no intervention ( n  = 32). Outcomes included complete remission, severity of symptoms and occurrence of adverse events. Results:  No difference ( p  = 1.00) in remission between groups following 10 weeks of intervention nor at 37 weeks follow-up was found. There was significant reduction in the severity of symptoms ( p  < 0.05) at end of intervention of ICBT compared to the control group, while the reduction in symptoms at 37 weeks follow-up was equal for the two groups. Two participants in the ICBT group and none in the control group reported adverse events. Conclusion:  We found no difference in remission, but a reduction of symptoms in the ICBT group compared with the control group at end of intervention. At six months follow-up the two groups showed the same level in the reduction of symptoms.  Trial registration:  Clinicaltrials.gov: NCT02499055. Registered 01 July 2015.",2020,"There was significant reduction in the severity of symptoms ( p  < 0.05) at end of intervention of ICBT compared to the control group, while the reduction in symptoms at 37 weeks follow-up was equal for the two groups.","['Methods:  Sixty-four participants', 'anxiety disorders', 'adults with an anxiety disorder']","['ICBT', 'Internet-based therapy with FearFighter', ':  Internet-based cognitive behavioural self-help psychotherapy (ICBT', 'FearFighter ICBT program ( n \u2009=\u200932) or no intervention']","['severity of symptoms', 'complete remission, severity of symptoms and occurrence of adverse events', 'adverse events', 'reduction of symptoms']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",64.0,0.0505465,"There was significant reduction in the severity of symptoms ( p  < 0.05) at end of intervention of ICBT compared to the control group, while the reduction in symptoms at 37 weeks follow-up was equal for the two groups.","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Fenger', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Gentofte, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lindschou', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Gentofte, Denmark.'}, {'ForeName': 'Jan Hein', 'Initials': 'JH', 'LastName': 'Dybkjaer', 'Affiliation': 'Student Counselling Service, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Gentofte, Denmark.'}]",Nordic journal of psychiatry,['10.1080/08039488.2020.1755363']
319,32402553,"Visual Field Outcomes from the Multicenter, Randomized Controlled Laser in Glaucoma and Ocular Hypertension Trial (LiGHT).","PURPOSE


To compare visual field outcomes of ocular hypertensive and glaucoma patients treated first with medical therapy with those treated first with selective laser trabeculoplasty (SLT).
DESIGN


Secondary analysis of patients from the Laser in Glaucoma and Ocular Hypertension study, a multicenter randomized controlled trial.
PARTICIPANTS


Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with SLT.
METHODS


Visual fields (VFs) were measured using standard automated perimetry and arranged in series (median length and duration, 9 VFs over 48 months). Hierarchical linear models were used to estimate pointwise VF progression rates, which were then averaged to produce a global progression estimate for each eye. Proportions of points and patients in each treatment group with fast (<-1 dB/year) or moderate (<-0.5 dB/year) progression were compared using log-binomial regression.
MAIN OUTCOME MEASURES


Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD).
RESULTS


A greater proportion of eyes underwent moderate or fast TD progression in the medical therapy group compared with the SLT group (26.2% vs. 16.9%; risk ratio [RR], 1.55; 95% confidence interval [CI], 1.23-1.93; P < 0.001). A similar pattern was observed for pointwise rates (medical therapy, 26.1% vs. SLT, 19.0%; RR, 1.37; 95% CI, 1.33-1.42; P < 0.001). A greater proportion of pointwise PD rates were categorized as moderate or fast in the medical therapy group (medical therapy, 11.5% vs. SLT, 8.3%; RR, 1.39; 95% CI, 1.32-1.46; P < 0.001). No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
CONCLUSIONS


A slightly larger proportion of ocular hypertensive and glaucoma patients treated first with medical therapy underwent rapid VF progression compared with those treated first with SLT.",2020,"No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
","['patients from the Laser in Glaucoma and Ocular Hypertension study', 'Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with', 'ocular hypertensive and glaucoma patients treated first with']","['medical therapy', 'SLT', 'selective laser trabeculoplasty (SLT']","['pointwise rates', 'fast TD progression', 'proportion of eyes that underwent moderate or fast PD progression', 'pointwise PD rates', 'Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851409', 'cui_str': 'Glaucoma and ocular hypertension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0639216,"No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Wright', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom; Health Data Research UK, London, United Kingdom.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Konstantakopoulou', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom; Division of Optics and Optometry, University of West Attica, Athens, Greece.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Montesano', 'Affiliation': 'Optometry and Visual Science, School of Health Science, City, University of London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Crabb', 'Affiliation': 'Optometry and Visual Science, School of Health Science, City, University of London, London, United Kingdom. Electronic address: David.Crabb1@city.ac.uk.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.029']
320,32205684,"Post-operative Single-shot Epidural Fentanyl and Bupivacaine for Post-operative Analgesia after Lumbar Decompression: A Prospective, Double-Blind Randomized Study.","STUDY DESIGN


Randomized-clinical trial OBJECTIVE.: To evaluate the efficacy of the post-operative single-shot bolus of epidural Fentanyl and Bupivicaine in providing pain relief post-lumbar decompression surgery.
SUMMARY OF BACKGROUND DATA


Despite lumbar decompression's success in alleviating symptoms of sciatica, radiculopathy, and neurogenic claudication, transient back and buttock pain has been a common complaint postoperatively. Providing good post-operative pain alleviation predicts patient's quality of recovery.
METHODS


We performed a randomized, double-blinded, clinical trial. Forty-five patients scheduled for lumbar decompression for a years period who were randomly assigned to receive a postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution via an intraoperatively placed epidural catheter immediately after wound closure, before dressing application. Facial pain scale scores (from 0 to 10) were measured at 3 time points after surgery (fully awake at recovery room, transfer to ward, first postoperative day). Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge were also evaluated.
RESULTS


Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001). In turn, they also received less on-demand oral pain medications than those in the control group (p = 0.000). The mean time to ambulation was 0.09 days in the epidural group and 0.91 days in the decompression-alone group (p = 0.000). Criteria for hospital discharge was usually met on Day 0 in the epidural and Day 1 in the control group (p = 0.000). Within the study period, only one infection was noted in the epidural group which necessitated additional lumbar spine surgery (4.3%). No adverse events or complications related to Fentanyl use were observed.
CONCLUSIONS


A postoperative bolus of Fentanyl and Bupivacaine is effective in reducing early postoperative pain without the related complications of opiod administration.
LEVEL OF EVIDENCE


2.",2020,"RESULTS


Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","['Forty-five patients scheduled for lumbar decompression for a years period', 'Post-operative Analgesia after Lumbar Decompression']","['postoperative bolus of 10-mL solution of 50 mcg of Fentanyl, 0.125% Bupivacaine, and 0.9% saline solution', 'Post-operative Single-shot Epidural Fentanyl and Bupivacaine', 'Fentanyl and Bupivacaine', 'epidural Fentanyl and Bupivicaine']","['demand oral pain medications', 'mean time to ambulation', 'Criteria for hospital discharge', 'additional lumbar spine surgery', 'Pain scores', 'Postoperative need for oral analgesics, time to independent ambulation, associated adverse events, and time to hospital discharge', 'early postoperative pain', 'Facial pain scale scores']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0221776', 'cui_str': 'Painful mouth (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.4784,"RESULTS


Pain scores were noted to be significantly lower at all time points in the epidural group (P < 0.001).","[{'ForeName': 'Mannuel Feliciano B', 'Initials': 'MFB', 'LastName': 'Alican', 'Affiliation': ""Institue of Orthopedics and Sports Medicine, St. Luke's Medical Center Quezon City, Philippines.""}, {'ForeName': 'Mario R', 'Initials': 'MR', 'LastName': 'Ver', 'Affiliation': ""Institue of Orthopedics and Sports Medicine, St. Luke's Medical Center Quezon City, Philippines.""}, {'ForeName': 'Miguel Rafael D', 'Initials': 'MRD', 'LastName': 'Ramos', 'Affiliation': ""Institue of Orthopedics and Sports Medicine, St. Luke's Medical Center Quezon City, Philippines.""}, {'ForeName': 'Lulu Joan C', 'Initials': 'LJC', 'LastName': 'Mamaril', 'Affiliation': ""Department of Anesthesiology, St. Luke's Medical Center Quezon City, Philippines.""}]",Spine,['10.1097/BRS.0000000000003449']
321,32406312,High Salt Intake Augments Blood Pressure Responses During Submaximal Aerobic Exercise.,"Background High sodium (Na + ) intake is a widespread cardiovascular disease risk factor. High Na +  intake impairs endothelial function and exaggerates sympathetic reflexes, which may augment exercising blood pressure (BP) responses. Therefore, this study examined the influence of high dietary Na +  on BP responses during submaximal aerobic exercise. Methods and Results Twenty adults (8F/12M, age=24±4 years; body mass index 23.0±0.6 kg·m -2 ; VO 2 peak=39.7±9.8 mL·min -1 ·kg -1 ; systolic BP=111±10 mm Hg; diastolic BP=64±8 mm Hg) participated in this randomized, double-blind, placebo-controlled crossover study. Total Na +  intake was manipulated via ingestion of capsules containing either a placebo (dextrose) or table salt (3900 mg Na + /day) for 10 days each, separated by ≥2 weeks. On day 10 of each intervention, endothelial function was assessed via flow-mediated dilation followed by BP measurement at rest and during 50 minutes of cycling at 60% VO 2peak . Throughout exercise, BP was assessed continuously via finger photoplethysmography and every 5 minutes via auscultation. Venous blood samples were collected at rest and during the final 10 minutes of exercise for assessment of norepinephrine. High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001). Average exercising systolic BP was augmented following high Na +  (placebo=Δ30.0±16.3 versus Na + =Δ38.3±16.2 mm Hg;  P =0.03) and correlated to the reduction in flow-mediated dilation ( R =-0.71,  P =0.002). Resting norepinephrine concentration was not different between conditions ( P =0.82). Norepinephrine increased during exercise ( P =0.002), but there was no Na +  effect ( P =0.26). Conclusions High dietary Na +  augments BP responses during submaximal aerobic exercise, which may be mediated, in part, by impaired endothelial function.",2020,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"['Hg; diastolic BP=64±8\xa0mm\xa0Hg', 'Twenty adults (8F/12M']","[' High sodium (Na + ) intake', 'Norepinephrine', 'High Na +  intake', 'placebo (dextrose) or table salt (3900', 'High Salt Intake', 'high dietary Na ', 'placebo']","['BP responses', 'endothelial function', 'endothelial function and exaggerates sympathetic reflexes', 'Venous blood samples', 'reduction in flow-mediated dilation', 'exercising blood pressure (BP) responses', 'urinary Na +  excretion', 'Resting norepinephrine concentration', 'Average exercising systolic BP', 'reduced flow-mediated dilation']","[{'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0206136', 'cui_str': 'Dietary Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.259216,High Na +  intake increased urinary Na +  excretion (placebo=140±68 versus Na + =282±70 mmol·24H -1 ;  P <0.001) and reduced flow-mediated dilation (placebo=7.2±2.4 versus Na + =4.2±1.7%;  P <0.001).,"[{'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology University of Connecticut Storrs CT.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology University of Delaware Newark DE.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015633']
322,32402523,Treatment Adequacy and Adherence as Predictors of Depression Response in Primary Care.,"OBJECTIVE


Primary care is the de facto mental health system in the United States where physicians treat large numbers of depressed older adults with antidepressant medication. This study aimed to examine whether antidepressant dosage adequacy and patient adherence are associated with depression response among middle-aged and older adults prescribed with antidepressants by their primary care provider.
DESIGN


A secondary analysis was conducted on a sample drawn from a randomized controlled trial comparing Treatment as Usual to Treatment Initiation Program, an adherence intervention. Treatment Initiation Program improved adherence but not depression compared to Treatment as Usual (Sirey et al., 2017). For this analysis, we examined dosing adequacy and adherence at 6 and 12 weeks as predictors of depression response in both groups at 12 and 24 weeks.
SETTING


Primary care practices.
PARTICIPANTS


One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider.
MEASUREMENTS


Depression response was defined as 50% reduction on the Hamilton Rating Scale for Depression. Adherence was defined as taking 80% of doses at follow-up interviews (6 and 12 weeks). Patient-reported dosage and duration of antidepressant therapy was collected using the Composite Antidepressant Score (adequacy score of >3) at follow-up.
RESULTS


Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
CONCLUSION


As physicians prescribe antidepressants to the diverse group of adults seen in primary care, special attention to patients' views and approach to adherence may improve depression outcomes.",2020,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
","['middle-aged and older adults prescribed with antidepressants by their primary care provider', 'One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider', 'depressed older adults with antidepressant medication', 'Primary care practices']",[],"['Greater adherence', 'Depression response', 'Hamilton Rating Scale for Depression', 'depression response', 'Adherence']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",187.0,0.0742356,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55).
","[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA). Electronic address: jsirey@med.cornell.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Kales', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California at Davis (HCK).'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.014']
323,32402554,"Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).","PURPOSE


Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.
DESIGN


Multicenter cohort study.
PARTICIPANTS


Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion).
METHODS


Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit.
MAIN OUTCOME MEASURES


Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST).
RESULTS


Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9).
CONCLUSIONS


Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.",2020,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","['Participants', 'Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion', 'for center-involved diabetic macular edema (CI-DME', 'eyes with DME']","['anti-VEGF therapy', 'aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment', 'Aflibercept, Bevacizumab, or Ranibizumab']","['Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST', '5-year visit, mean VA', '5-year visit', 'mean 5-year VA', 'Mean CST', 'mean retinal thickness', 'mean VA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",,0.306087,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, Columbia, South Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Josic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Pikesville, Maryland.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.021']
324,32402555,Spectral-Domain OCT Analysis of Risk Factors for Macular Atrophy Development in the HARBOR Study for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To identify baseline risk factors for macular atrophy (MA) development in HARBOR via a longitudinal assessment of monthly spectral-domain (SD)-OCT scans. Previous analyses of MA in HARBOR examined data from color fundus photography (CFP) and fluorescein angiography (FA).
DESIGN


Retrospective, post hoc analysis of SD-OCT images from HARBOR (ClinicalTrials.gov identifier, NCT00891735), a phase 3, multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial.
PARTICIPANTS


Patients (N = 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with intravitreal ranibizumab 0.5 mg monthly (n = 275), 0.5 mg pro re nata (PRN) after 3 loading doses (n = 275), 2.0 mg monthly (n = 274), or 2.0 mg PRN (n = 273).
METHODS


Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up (N = 941) were examined monthly from baseline to month 24 by masked reading center-trained graders. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, loss of retinal pigment epithelium, and loss of outer retinal layers. Multivariable proportional hazards regression was performed for time to atrophy development.
MAIN OUTCOME MEASURES


Risk factors for MA as determined by time to MA development over 24 months of treatment.
RESULTS


Baseline risk factors for MA were confirmed from prior analyses that used CFP and FA data: absence of subretinal fluid, presence of intraretinal cysts, presence of Type 3 neovascularization, and presence of atrophy in the fellow eye. This analysis of SD-OCT data identified new baseline risk factors for MA: higher central drusen volume, lower choroidal thickness, presence of nascent atrophy, presence of reticular pseudodrusen, and increased central foveal thickness. Ranibizumab treatment regimen and dose level were not found to be risk factors for MA development.
CONCLUSIONS


In this analysis of a major nAMD trial using CAM atrophy criteria, new baseline risk factors for MA development were identified using an SD-OCT dataset. Risk factors for MA development identified by prior analyses were confirmed. Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.",2020,Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.,"['Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up', 'Patients (N\xa0= 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with']","['Ranibizumab', 'intravitreal ranibizumab 0.5 mg monthly (n\xa0= 275), 0.5 mg pro re nata (PRN', 'ranibizumab']",['central foveal thickness'],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",1097.0,0.0829013,Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.,"[{'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: ssadda@doheny.org.'}, {'ForeName': 'Nizar Saleh', 'Initials': 'NS', 'LastName': 'Abdelfattah', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': ""Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Marion', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morgenthien', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.031']
325,32405884,Effect of patient-specific instrument on lowering threshold for junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients.,"PURPOSE


To create a patient-specific instrument (PSI) in lowering the surgical experience requirement for junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients.
METHODS


Combined with rapid prototyping technology, we created a PSI and established DDH hip model in vitro. We enrolled 48 junior physicians and randomly assigned them into two groups. After creation of the PSI, they performed simulated THA surgery on a full-scale hip model with or without PSI on DDH models. The planned prothesis orientation, post-operative prothesis orientation, and surgery time were recorded.
RESULTS


The final cup inclination was 42.0 ± 0.8° in PSI group and 37.8 ± 2.0° in control group, while final cup anteversion was 16.0 ± 0.7° in PSI group and 24.7 ± 3.5° in control group. The △inclination in PSI group was smaller than that in control group (4.2 ± 0.5° vs 9.5 ± 1.4°, P < 0.01), so does △inclination (2.9 ± 0.4° in PSI group vs 15.2 ± 2.5° in control group, P < 0.01). The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01). At the same time, the PSI group did not prolong the operation time (P = 0.551).
CONCLUSION


The PSI can greatly increase the accuracy of placing the cup orientation and lower the threshold for junior physicians to perform THA on DDH patients. It could be a training tool for them to increase their THA surgical skills.",2020,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"['junior physicians to perform total hip arthroplasty (THA) on developmental dysplasia of the hip (DDH) patients', '48 junior physicians', 'junior physicians to perform total hip arthroplasty on developmental dysplasia of the hip patients']","['patient-specific instrument (PSI', 'patient-specific instrument', 'rapid prototyping technology']",['operation time'],"[{'cui': 'C0524635', 'cui_str': 'Physicians, Junior'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",48.0,0.0184023,The outlier percent was 8.3% in PSI group and 70.8% in control group (P < 0.01).,"[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Sports Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chenggong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China. Dr_zhongda@126.com.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yihe', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Digital Orthopaedic Laboratory, Xiangya Hospital, Central South University, Changsha, Hunan, China.'}]",International orthopaedics,['10.1007/s00264-020-04599-6']
326,32404854,Clinical Value of Serum LHPP-associated miR-765 in the Prognosis of Laparoscopic or Open Hepatectomy for Hepatocellular Carcinoma.,"PURPOSE


The current study aims to investigate the effect of tumor suppressor LHPP-associated microRNA (miR)-765 on the prognosis of laparoscopic hepatectomy (LH) or open hepatectomy (OH) for hepatocellular carcinoma (HCC).
MATERIALS AND METHODS


A total of 160 patients with HCC were enrolled and randomly divided into the LH or OH group. According to the operation time, these patients were followed up for 12 months, and the number of deaths and the corresponding death time during the follow-up period were counted.
RESULTS


The authors found that the LHPP gene levels in HCC tissues were lower than that in adjacent normal tissues, whereas miR-765 was overexpressed in HCC tissue. Overexpression of miR-765 promoted the epithelial-mesenchymal transition and proliferation and inhibited apoptosis of HCC through directly downregulating LHPP expression. Serum miR-765 expression level was significantly associated with lymph node metastasis and histologic grading. Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
CONCLUSION


For patients with a low miR-765 level, both LH and OH are available, otherwise, LH is more recommended.",2020,"Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
","['Hepatocellular Carcinoma', '160 patients with HCC', 'hepatocellular carcinoma (HCC']","['laparoscopic hepatectomy (LH) or open hepatectomy (OH', 'LH or OH', 'tumor suppressor LHPP-associated microRNA (miR)-765']","['overall survival rate', 'Serum miR-765 expression level', 'LHPP gene levels in HCC tissues', 'number of deaths and the corresponding death time']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0079427', 'cui_str': 'Antioncogene'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}]",160.0,0.0345093,"Survival analysis showed that the overall survival rate in 12 months after the operation was significantly lower in the OH-high miR-765 group (P<0.05).
","[{'ForeName': 'Jingting', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Hyperbaric Oxidation, NanHua Hospital.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital, University of South China.'}, {'ForeName': 'Xiuda', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""Department of Urology, Hengyang Hospital, Southern Medical University, Hengyang City, Hunan Province, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Xianrong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Dunxue', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}, {'ForeName': 'Xianzhou', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Departments of Hepatobiliary Surgery.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000808']
327,32406919,"Changes in Dietary Inflammatory Potential Predict Changes in Sleep Quality Metrics, but Not Sleep Duration.","STUDY OBJECTIVES


Non-pharmacological sleep interventions may improve sleep profiles without the side-effects observed with many pharmacological sleep aids. The objective of this research was to examine the association between sleep and inflammation and to examine how changes in dietary inflammatory potential influence changes in sleep.
METHODS


The Inflammation Management Intervention Study (IMAGINE), which was a dietary intervention designed to lower inflammation, provided access to 24-hour dietary recalls (24HR), objectively measured sleep using Sensewear™ armbands, and a range of self-reported demographics, health histories, lifestyle behaviors, psychosocial metrics, anthropometric measurements, and inflammatory biomarkers. Dietary Inflammatory Index (DII®) scores were calculated from three unannounced 24HR-derived estimated intakes of whole foods and micro and macronutrients over a 2-week period at baseline and post-intervention (i.e., month 3). Statistical analyses primarily utilized linear regression.
RESULTS


At baseline, for every one-minute increase in sleep onset latency (SOL), tumor necrosis factor-α (TNF-α) increased by 0.015 pg/ml (± 0.008, P=0.05). Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01). Every one-minute increase in wake-after-sleep-onset (WASO) increased both CRP and interleukin-6. Compared to participants with pro-inflammatory DII changes over 3 months, those with anti-inflammatory changes decreased WASO (0 vs. -25 minutes, respectively, P<0.01) and improved sleep efficiency (-2.1% vs. +2.6%, respectively, P=0.04).
CONCLUSION


Non-pharmacological treatments, such as anti-inflammatory diets, may improve sleep in some adults. Future research involving dietary treatments to improve sleep should not only focus on the general population, but in those commonly experiencing co-morbid sleep complaints.",2020,"Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01).",[],[],"['C-reactive protein (CRP', 'Sleep Quality Metrics', 'Dietary Inflammatory Index (DII®) scores', '24-hour dietary recalls (24HR), objectively measured sleep using Sensewear™ armbands, and a range of self-reported demographics, health histories, lifestyle behaviors, psychosocial metrics, anthropometric measurements, and inflammatory biomarkers', 'WASO', 'sleep onset latency (SOL), tumor necrosis factor-α (TNF-α', 'sleep efficiency']",[],[],"[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0455458', 'cui_str': 'PMH - past medical history'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0144196,"Every one-percentage increase in sleep efficiency was associated with decreased C-reactive protein (CRP) of -0.088 mg/L (± 0.032, P=0.01).","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jessup', 'Affiliation': 'Department of Epidemiology and Biostatistics Columbia, SC.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Turner-McGrievy', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, Columbia, SC.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Department of Epidemiology and Biostatistics Columbia, SC.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hurley', 'Affiliation': 'Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, SC.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics Columbia, SC.'}]",Sleep,['10.1093/sleep/zsaa093']
328,32404430,Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients (GAPS study): randomised controlled trial.,"OBJECTIVES


To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.
DESIGN


Open, multicentre, randomised, controlled, non-inferiority trial.
SETTING


Seven National Health Service tertiary hospitals in the United Kingdom.
PARTICIPANTS


1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.
INTERVENTION


Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.
OUTCOME MEASURES


The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.
RESULTS


Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.
CONCLUSIONS


For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.
TRIAL REGISTRATION


ISRCTN13911492.",2020,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","['1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate', 'patients who have elective surgery and are at moderate or high risk of venous thromboembolism', 'patients undergoing elective surgery', 'Seven National Health Service tertiary hospitals in the United Kingdom', '1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery', 'elective surgical patients (GAPS study', 'Between May 2016 and January 2019, 1905 participants were randomised']","['low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS', 'LMWH', 'Graduated compression stockings', 'graduated compression stockings (GCS', 'GCS']","['imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms', 'quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1905.0,0.261781,"Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shalhoub', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'University of Birmingham & University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dhillon', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Everington', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, Hampshire, UK.'}, {'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK.'}, {'ForeName': 'Zaed', 'Initials': 'Z', 'LastName': 'Hamady', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Beverley J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gerrard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London & Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London W6 8RF, UK a.h.davies@imperial.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m1309']
329,32406858,Web-Based Self-Management for Patients With Lymphoma: Assessment of the Reach of Intervention of a Randomized Controlled Trial.,"BACKGROUND


Randomized controlled trials (RCTs) often provide accurate estimates of the internal validity of an intervention but lack information on external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma in a population-based setting.
OBJECTIVE


The objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention. An additional objective was to assess differences on RCT outcome variables between RCT and paper respondents.
METHODS


Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion determined RCT enrollment, whereas paper respondents were followed observationally.
RESULTS


A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility. Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT. The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001). In addition, 25.7% (229/892) of those invited opted to participate in the paper-based observational follow-up study. Compared with paper respondents, RCT participants were younger (P<.001), with a higher proportion of men (P=.002), and had higher education levels (P=.02). RCT participants more often wanted to receive all available information on their disease (P<.001), whereas paper respondents reported higher levels of emotional distress (P=.009).
CONCLUSIONS


From a population-based sample of eligible patients, the participation rate in the RCT was approximately 25%. RCT participants may not be representative of the target population because of different sociodemographic and clinical characteristics. Since RCT participants represent a minority of the target population, RCT results should be interpreted with caution as patients in the RCT may be those least in need of a self-management intervention.
TRIAL REGISTRATION


Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790.",2020,The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001).,"['Patients With Lymphoma', 'Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics', 'A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility', 'Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT', 'From a population-based sample of eligible patients', 'RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention', 'patients with lymphoma in a population-based setting', 'Eligible patients were invited to participate in an RCT and complete a questionnaire']","['RCT', 'NTR5953', 'self-management intervention']","['higher education levels', 'emotional distress', 'participation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424933', 'cui_str': 'Higher education'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",1193.0,0.125336,The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001).,"[{'ForeName': 'Lindy P J', 'Initials': 'LPJ', 'LastName': 'Arts', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Oerlemans', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.'}, {'ForeName': 'Eduardus F M', 'Initials': 'EFM', 'LastName': 'Posthuma', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Hospital, Delft, Netherlands.'}, {'ForeName': 'Djamila E', 'Initials': 'DE', 'LastName': 'Issa', 'Affiliation': ""Department of Internal Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Oosterveld', 'Affiliation': 'Department of Internal Medicine, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van der Griend', 'Affiliation': 'Department of Internal Medicine, Diakonessenhuis, Utrecht/Zeist, Netherlands.'}, {'ForeName': 'Marten R', 'Initials': 'MR', 'LastName': 'Nijziel', 'Affiliation': 'Department of Internal Medicine, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Lonneke V', 'Initials': 'LV', 'LastName': 'van de Poll-Franse', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.'}]",Journal of medical Internet research,['10.2196/17018']
330,32406864,"Gratitude at Work: Prospective Cohort Study of a Web-Based, Single-Exposure Well-Being Intervention for Health Care Workers.","BACKGROUND


Emotional exhaustion (EE) in health care workers is common and consequentially linked to lower quality of care. Effective interventions to address EE are urgently needed.
OBJECTIVE


This randomized single-exposure trial examined the efficacy of a gratitude letter-writing intervention for improving health care workers' well-being.
METHODS


A total of 1575 health care workers were randomly assigned to one of two gratitude letter-writing prompts (self- vs other focused) to assess differential efficacy. Assessments of EE, subjective happiness, work-life balance, and tool engagement were collected at baseline and 1-week post intervention. Participants received their EE score at baseline and quartile benchmarking scores. Paired-samples t tests, independent t tests, and correlations explored the efficacy of the intervention. Linguistic Inquiry and Word Count software assessed the linguistic content of the gratitude letters and associations with well-being.
RESULTS


Participants in both conditions showed significant improvements in EE, happiness, and work-life balance between the intervention and 1-week follow-up (P<.001). The self-focused (vs other) instruction conditions did not differentially predict improvement in any of the measures (P=.91). Tool engagement was high, and participants reporting higher motivation to improve their EE had higher EE at baseline (P<.001) and were more likely to improve EE a week later (P=.03). Linguistic analyses revealed that participants high on EE at baseline used more negative emotion words in their letters (P=.005). Reduction in EE at the 1-week follow-up was predicted at the level of a trend by using fewer first-person (P=.06) and positive emotion words (P=.09). No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05).
CONCLUSIONS


This single-exposure gratitude letter-writing intervention appears to be a promising low-cost, brief, and meaningful tool to improve the well-being of health care workers.",2020,"No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05).
","['Health Care Workers', '1575 health care workers', 'health care workers']","['gratitude letter-writing intervention', 'Single-Exposure Well-Being Intervention', 'gratitude letter-writing prompts (self- vs other focused']","['Assessments of EE, subjective happiness, work-life balance, and tool engagement', 'negative emotion words', 'EE, happiness, and work-life balance']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C4277700', 'cui_str': 'Work-Life Balance'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0319504,"No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05).
","[{'ForeName': 'Kathryn C', 'Initials': 'KC', 'LastName': 'Adair', 'Affiliation': 'Duke Center for Healthcare Safety and Quality, Duke University Health System, Durham, NC, United States.'}, {'ForeName': 'Larissa G', 'Initials': 'LG', 'LastName': 'Rodriguez-Homs', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Sabran', 'Initials': 'S', 'LastName': 'Masoud', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mosca', 'Affiliation': 'Duke Network Services Duke University Health System, Duke University Health System, Durham, NC, United States.'}, {'ForeName': 'J Bryan', 'Initials': 'JB', 'LastName': 'Sexton', 'Affiliation': 'Duke Center for Healthcare Safety and Quality, Duke University Health System, Durham, NC, United States.'}]",Journal of medical Internet research,['10.2196/15562']
331,32401715,"Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial.","BACKGROUND


Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. We assessed the efficacy and safety of combined interferon beta-1b, lopinavir-ritonavir, and ribavirin for treating patients with COVID-19.
METHODS


This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were admitted to six hospitals in Hong Kong. Patients were randomly assigned (2:1) to a 14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days (combination group) or to 14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h (control group). The primary endpoint was the time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT04276688.
FINDINGS


Between Feb 10 and March 20, 2020, 127 patients were recruited; 86 were randomly assigned to the combination group and 41 were assigned to the control group. The median number of days from symptom onset to start of study treatment was 5 days (IQR 3-7). The combination group had a significantly shorter median time from start of study treatment to negative nasopharyngeal swab (7 days [IQR 5-11]) than the control group (12 days [8-15]; hazard ratio 4·37 [95% CI 1·86-10·24], p=0·0010). Adverse events included self-limited nausea and diarrhoea with no difference between the two groups. One patient in the control group discontinued lopinavir-ritonavir because of biochemical hepatitis. No patients died during the study.
INTERPRETATION


Early triple antiviral therapy was safe and superior to lopinavir-ritonavir alone in alleviating symptoms and shortening the duration of viral shedding and hospital stay in patients with mild to moderate COVID-19. Future clinical study of a double antiviral therapy with interferon beta-1b as a backbone is warranted.
FUNDING


The Shaw-Foundation, Richard and Carol Yu, May Tam Mak Mei Yin, and Sanming Project of Medicine.",2020,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"['patients with COVID-19', '127 patients were recruited; 86', 'adults with COVID-19 who were admitted to six hospitals in Hong Kong', 'Between Feb 10 and March 20, 2020', 'patients admitted to hospital with COVID-19', 'patients with mild to moderate COVID-19']","['lopinavir-ritonavir alone', 'lopinavir 400 mg and ritonavir', 'interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'combined interferon beta-1b, lopinavir-ritonavir, and ribavirin', 'lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin', 'lopinavir-ritonavir']","['self-limited nausea and diarrhoea', 'shorter median time', 'efficacy and safety', 'time to providing a nasopharyngeal swab negative for severe acute respiratory syndrome coronavirus 2 RT-PCR, and was done in the intention-to-treat population', 'duration of viral shedding and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0992889', 'cui_str': 'Ritonavir 100 MG'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",127.0,0.118203,Adverse events included self-limited nausea and diarrhoea with no difference between the two groups.,"[{'ForeName': 'Ivan Fan-Ngai', 'Initials': 'IF', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Cheung', 'Initials': 'KC', 'LastName': 'Lung', 'Affiliation': 'Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Eugene Yuk-Keung', 'Initials': 'EY', 'LastName': 'Tso', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tom Wai-Hin', 'Initials': 'TW', 'LastName': 'Chung', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Man-Yee', 'Initials': 'MY', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Yuk-Yung', 'Initials': 'YY', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Anthony Raymond', 'Initials': 'AR', 'LastName': 'Tam', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Hoi-Ping', 'Initials': 'HP', 'LastName': 'Shum', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alan Ka-Lun', 'Initials': 'AK', 'LastName': 'Wu', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kit-Man', 'Initials': 'KM', 'LastName': 'Sin', 'Affiliation': 'Department of Medicine, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Shing', 'Initials': 'WS', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Lam', 'Initials': 'WL', 'LastName': 'Law', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'David Christopher', 'Initials': 'DC', 'LastName': 'Lung', 'Affiliation': 'Department of Microbiology, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sin', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Yeung', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Cyril Chik-Yan', 'Initials': 'CC', 'LastName': 'Yip', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Ricky Ruiqi', 'Initials': 'RR', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China; State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Agnes Yim-Fong', 'Initials': 'AY', 'LastName': 'Fung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Erica Yuen-Wing', 'Initials': 'EY', 'LastName': 'Yan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kit-Hang', 'Initials': 'KH', 'LastName': 'Leung', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jonathan Daniel', 'Initials': 'JD', 'LastName': 'Ip', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Allen Wing-Ho', 'Initials': 'AW', 'LastName': 'Chu', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Wan-Mui', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Anthony Chin-Ki', 'Initials': 'AC', 'LastName': 'Ng', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Microbiology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Microbiology, United Christian Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine and Geriatrics, Ruttonjee Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Tak-Chiu', 'Initials': 'TC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Johnny Wai-Man', 'Initials': 'JW', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Queen Elizabeth Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wing-Wah', 'Initials': 'WW', 'LastName': 'Yan', 'Affiliation': 'Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Wai-Ming', 'Initials': 'WM', 'LastName': 'Chan', 'Affiliation': 'Department of Intensive Care, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Jasper Fuk-Woo', 'Initials': 'JF', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Albert Kwok-Wai', 'Initials': 'AK', 'LastName': 'Lie', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Owen Tak-Yin', 'Initials': 'OT', 'LastName': 'Tsang', 'Affiliation': 'Department of Medicine, Princess Margaret Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Vincent Chi-Chung', 'Initials': 'VC', 'LastName': 'Cheng', 'Affiliation': 'Department of Microbiology, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Tak-Lun', 'Initials': 'TL', 'LastName': 'Que', 'Affiliation': 'Department of Microbiology, Tuen Mun Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Chak-Sing', 'Initials': 'CS', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Hung', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kelvin Kai-Wang', 'Initials': 'KK', 'LastName': 'To', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China.'}, {'ForeName': 'Kwok-Yung', 'Initials': 'KY', 'LastName': 'Yuen', 'Affiliation': 'State Key Laboratory of Emerging Infectious Diseases, Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region (SAR), China. Electronic address: kyyuen@hku.hk.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31042-4']
332,32060017,Time Course of Normalization of Functional β-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes.,"OBJECTIVE


To assess functional β-cell capacity in type 2 diabetes during 2 years of remission induced by dietary weight loss.
RESEARCH DESIGN AND METHODS


A Stepped Insulin Secretion Test with Arginine was used to quantify functional β-cell capacity by hyperglycemia and arginine stimulation. Thirty-nine of 57 participants initially achieved remission (HbA 1c  <6.5% [<48 mmol/mol] and fasting plasma glucose <7 mmol/L on no antidiabetic drug therapy) with a 16.4 ± 7.7 kg weight loss and were followed up with supportive advice on avoidance of weight regain. At 2 years, 20 participants remained in remission in the study. A nondiabetic control (NDC) group, matched for age, sex, and weight after weight loss with the intervention group, was studied once.
RESULTS


During remission, median (interquartile range) maximal rate of insulin secretion increased from 581 (480-811) pmol/min/m 2  at baseline to 736 (542-998) pmol/min/m 2  at 5 months, 942 (565-1,240) pmol/min/m 2  at 12 months ( P  = 0.028 from baseline), and 936 (635-1,435) pmol/min/m 2  at 24 months ( P  = 0.023 from baseline;  n  = 20 of 39 of those initially in remission). This was comparable to the NDC group (1,016 [857-1,507] pmol/min/m 2 ) by 12 ( P  = 0.064) and 24 ( P  = 0.244) months. Median first-phase insulin response increased from baseline to 5 months (42 [4-67] to 107 [59-163] pmol/min/m 2 ;  P  < 0.0001) and then remained stable at 12 and 24 months (110 [59-201] and 125 [65-166] pmol/min/m 2 , respectively;  P  < 0.0001 vs. baseline) but lower than that of the NDC group (250 [226-429] pmol/min/m 2 ;  P  < 0.0001).
CONCLUSIONS


A gradual increase in assessed functional β-cell capacity occurred after weight loss, becoming similar to that of NDC group participants by 12 months. This result was unchanged at 2 years with continuing remission of type 2 diabetes.",2020,m 2  at 24 months ( P  = 0.023 from baseline;  n  = 20 of 39 of those initially in remission).,"['Type 2 Diabetes', 'A nondiabetic control (NDC) group, matched for age, sex, and weight after weight loss with the intervention group, was studied once', 'Thirty-nine of 57 participants initially achieved remission (HbA 1c  <6.5% [<48 mmol/mol] and fasting plasma glucose <7 mmol/L on no antidiabetic drug therapy) with a 16.4 ± 7.7 kg weight loss and were followed up with supportive advice on avoidance of weight regain', 'type 2 diabetes during 2 years of remission induced by dietary weight loss']",['NDC'],"['functional β-cell capacity', 'Median first-phase insulin response', 'insulin secretion']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",,0.0491014,m 2  at 24 months ( P  = 0.023 from baseline;  n  = 20 of 39 of those initially in remission).,"[{'ForeName': 'Sviatlana V', 'Initials': 'SV', 'LastName': 'Zhyzhneuskaya', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Mrabeh', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Peters', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Barnes', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Aribisala', 'Affiliation': 'Computer Science Department, Lagos State University, Lagos, Nigeria.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, U.K. roy.taylor@ncl.ac.uk.'}]",Diabetes care,['10.2337/dc19-0371']
333,32196620,Efficacy and safety of a novel hydrogel (HYADD4-G) in degenerative disc disease patients: a multicentric open label study.,"OBJECTIVE


In this premarket clinical study, we evaluated the efficacy and safety of a novel Hydrogel (HYADD4-G) for reducing low back pain (LBP) in patients with degenerative disc disease (DDD).
PATIENTS AND METHODS


Twenty-three patients with chronic LBP were enrolled. All patients presented with up to three lumbar black discs (Pfirrmann grade III or IV), LBP of at least 40 mm on the Visual Analogue Scale (VAS), and a Roland-Morris Disability Questionnaire (RMDQ) score of at least 9. Patients received a single 1.5 ml intradiscal injection of HYADD4-G (8 mg/ml), guided by X-ray. Our primary endpoint was the change in VAS score from baseline (day 0) to 4, 12, and 24 weeks. Our secondary endpoints were black disc hydration by Magnetic Resonance Imaging (MRI); the patient's therapeutic response according to the RMDQ; the quality of life, as determined by the EuroQol-5 Dimension (EQ-5D) Index; and a global assessment of patient health status, safety, and local tolerability.
RESULTS


Compared with baseline values, VAS score showed a significant reduction at each time point, and across the overall 24-week follow-up period (p < 0.0001). MRI scanning observed a significant reduction in Pfirrmann grade from baseline, by at least one grade, at both week 4 (p = 0.0039) and week 24 (p = 0.0010). Furthermore, compared with baseline values, there was a significant reduction in RMDQ score at each timepoint, and across the entire study period (p < 0.0001). The EQ-5D index increased significantly from baseline to week 24 (p = 0.0001). Finally, mean VAS scores for Patient Global Assessment (PTGA), and Clinical Observer Global Assessment (COGA), decreased significantly at each time point (p < 0.0001), except for week 4.
CONCLUSIONS


HYADD4-G proved to be an efficient reliever of low back pain due to DDD.",2020,"Compared with baseline values, VAS score showed a significant reduction at each time point, and across the overall 24-week follow-up period (p < 0.0001).","['patients with degenerative disc disease (DDD', 'All patients presented with up to three lumbar black discs (Pfirrmann grade III or IV), LBP of at least 40 mm on the', 'Twenty-three patients with chronic LBP were enrolled', 'degenerative disc disease patients']","['novel Hydrogel (HYADD4-G', 'single 1.5 ml intradiscal injection of HYADD4-G', 'novel hydrogel (HYADD4-G']","['change in VAS score', 'mean VAS scores for Patient Global Assessment (PTGA), and Clinical Observer Global Assessment (COGA', 'Efficacy and safety', 'VAS score', 'low back pain (LBP', 'efficacy and safety', 'Visual Analogue Scale (VAS), and a Roland-Morris Disability Questionnaire (RMDQ) score', 'RMDQ score', ""black disc hydration by Magnetic Resonance Imaging (MRI); the patient's therapeutic response according to the RMDQ; the quality of life, as determined by the EuroQol-5 Dimension (EQ-5D) Index; and a global assessment of patient health status, safety, and local tolerability"", 'EQ-5D index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0158266', 'cui_str': 'Disc Degradation'}, {'cui': 'C0011037', 'cui_str': 'Dichlorodiphenyldichloroethane'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0450402', 'cui_str': '40mm (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",23.0,0.0447901,"Compared with baseline values, VAS score showed a significant reduction at each time point, and across the overall 24-week follow-up period (p < 0.0001).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mazza', 'Affiliation': 'Interventional Radiology, Villa Donatello, Florence, Italy. ernestomazza@outlook.it.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marcia', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mondaini', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piras', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Giordan', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Torri', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Barbanti-Bròdano', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Parodi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202003_20539']
334,32199523,"Microbiota Stability and Gastrointestinal Tolerance in Response to a High-Protein Diet with and without a Prebiotic, Probiotic, and Synbiotic: A Randomized, Double-Blind, Placebo-Controlled Trial in Older Women.","BACKGROUND


Higher protein intakes may help reduce sarcopenia and facilitate recovery from illness and injury in older adults. However, high-protein diets (HPDs) including animal-sourced foods may negatively perturb the microbiota, and provision of probiotics and prebiotics may mitigate these effects.
OBJECTIVE


The aim of this study was to examine the effects of HPD, with and without a probiotic and/or prebiotic, on gut microbiota and wellness in older women.
DESIGN


We conducted an 18-week, double-blind, placebo-controlled, crossover study.
PARTICIPANTS/SETTING


Participants were healthy, older women (mean age±standard deviation=73.7±5.6 years; n=26) recruited from Florida.
INTERVENTION


Participants received a weight-maintenance HPD for 2-week periods and the following, in random order: HPD alone (1.5 to 2.2 g/kg/day protein); HPD plus multistrain probiotic formulation (1.54×10 9 Bifidobacterium bifidum HA-132, 4.62×10 9 Bifidobacterium breve HA-129, 4.62×10 9 Bifidobacterium longum HA-135, 4.62×10 9 Lactobacillus acidophilus HA-122, and 4.62×10 9 Lactobacillus plantarum HA-119), HPD plus prebiotic (5.6 g inulin), and HPD plus synbiotic (probiotic plus inulin), separated by 2-week washouts. Stools were collected per period for quantitative polymerase chain reaction (strain recovery) and 16S ribosomal RNA gene amplicon sequencing analyses (microbiota profile). Measures of gastrointestinal and general wellness were assessed.
MAIN OUTCOME MEASURES


Microbiota composition and probiotic strain recovery were measured.
STATISTICAL ANALYSES


Microbiota composition was analyzed by Wilcoxon signed-rank test and t test. Secondary outcomes were analyzing using generalized linear mixed models.
RESULTS


The microbiota profile demonstrated relative stability with the HPD; representation of Lactobacillus, Lactococcus, and Streptococcus were enhanced, whereas butyrate producers, Roseburia and Anaerostipes, were suppressed. Lactococcus was suppressed with synbiotic vs other HPD periods. Recovery was confirmed for all probiotic strains. Indicators of wellness were unchanged, with the exception of a minimal increase in gastrointestinal distress with inulin. Fat-free mass increased from baseline to study end.
CONCLUSIONS


An HPD adhering to the recommended acceptable macronutrient distribution ranges maintains wellness in healthy older women and exerts minor perturbations to the microbiome profile, a group that may benefit from a higher protein intake. ClinicalTrials.gov ID: NCT #02445560.",2020,"The microbiota profile demonstrated relative stability with the HPD; representation of Lactobacillus, Lactococcus, and Streptococcus were enhanced, whereas butyrate producers, Roseburia and Anaerostipes, were suppressed.","['older women', 'healthy older women', 'older adults', 'Participants were healthy, older women (mean age±standard deviation=73.7±5.6 years; n=26) recruited from Florida', 'Older Women']","['HPD alone (1.5 to 2.2 g/kg/day protein); HPD plus multistrain probiotic formulation (1.54×10 9 Bifidobacterium bifidum HA-132, 4.62×10 9 Bifidobacterium breve HA-129, 4.62×10 9 Bifidobacterium longum HA-135, 4.62×10 9 Lactobacillus acidophilus HA-122, and 4.62×10 9 Lactobacillus plantarum HA-119), HPD plus prebiotic (5.6 g inulin), and HPD plus synbiotic (probiotic plus inulin', 'placebo', 'weight-maintenance HPD', 'High-Protein Diet with and without a Prebiotic, Probiotic, and Synbiotic', 'HPD, with and without a probiotic and/or prebiotic', 'Placebo']","['Fat-free mass', 'gastrointestinal distress', 'Microbiota Stability and Gastrointestinal Tolerance', 'gastrointestinal and general wellness', 'Microbiota composition and probiotic strain recovery']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]",,0.199913,"The microbiota profile demonstrated relative stability with the HPD; representation of Lactobacillus, Lactococcus, and Streptococcus were enhanced, whereas butyrate producers, Roseburia and Anaerostipes, were suppressed.","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Varuni', 'Initials': 'V', 'LastName': 'Nagulesapillai', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Piano', 'Affiliation': ''}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Auger', 'Affiliation': ''}, {'ForeName': 'Stephanie-Anne', 'Initials': 'SA', 'LastName': 'Girard', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Christman', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Tompkins', 'Affiliation': ''}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Dahl', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.12.009']
335,31955478,Ultrasound-guided continuous deep serratus anterior plane block versus continuous thoracic paravertebral block for perioperative analgesia in videoscopic-assisted thoracic surgery.,"BACKGROUND


The deep serratus anterior plane block (SAPB) is a promising novel regional anaesthesia technique for blockade of the anterolateral chest wall. Evidence for the efficacy of SAPB versus other analgesic techniques in thoracic surgery remains inadequate.
AIMS


This study compared ultrasound-guided continuous SAPB with a surgically placed continuous thoracic paravertebral block (SPVB) technique in patients undergoing videoscopic-assisted thoracic surgery (VATS).
METHODS


In a single-centre, double-blinded, randomized, non-inferiority study, we allocated 40 patients undergoing VATS to either SAPB or SPVB, with both groups receiving otherwise standardized treatment, including multimodal analgesia. The primary outcome was 48-hr opioid consumption. Secondary outcomes included numerical rating scale (NRS) for postoperative pain, patient-reported worst pain score (WPS) as well as functional measures (including mobilization distance and cough strength).
RESULTS


A 48-hr opioid consumption for the SAPB group was non-inferior compared with SPVB. SAPB was associated with improved NRS pain scores at rest, with cough and with movement at 24 hr postoperatively (p = .007, p = .001 and p = .012, respectively). SAPB was also associated with a lower WPS (p = .008). Day 1 walking distance was improved in the SAPB group (p = .012), whereas the difference in cough strength did not reach statistical significance (p = .071). There was no difference in haemodynamics, opioid side effects, length of hospital stay or patient satisfaction between the two groups.
CONCLUSIONS


The SAPB, as part of a multimodal analgesia regimen, is non-inferior in terms of 48-hr opioid consumption compared to SPVB and is associated with improved functional measures in thoracic surgical patients. ClinicalTrials.gov Identifier: NCT03768193.
SIGNIFICANCE


The SAPB interfascial plane block is an efficacious alternative method of opioid-sparing analgesia in high-risk thoracic surgical patients as part of an enhanced recovery programme.",2020,"SAPB was associated with improved NRS pain scores at rest, with cough and with movement at 24-hours postoperatively (p=0.007, p=0.001 and p=0.012 respectively).","['Videoscopic-Assisted Thoracic Surgery', 'thoracic surgical patients', 'patients undergoing videoscopic-assisted thoracic surgery (VATS', '40 patients undergoing']","['ultrasound-guided continuous SAPB with a surgically-placed continuous thoracic paravertebral block (SPVB) technique', 'VATS to either SAPB or SPVB, with both groups receiving otherwise standardised treatment, including multimodal analgesia', 'SAPB', 'Ultrasound-Guided Continuous Deep Serratus Anterior Plane Block Versus Continuous Thoracic Paravertebral Block']","['numerical rating scores (NRS) for postoperative pain, patient-reported ""worst pain score"" (WPS) as well as functional measures (including mobilisation distance and cough strength', '48-hour opioid consumption', 'NRS pain scores', 'cough strength', 'functional measures', 'lower ""worst pain score', 'haemodynamics, opioid side-effects, length of hospital stay, or patient satisfaction', 'Day 1 walking distance (D1WD']","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4708767', 'cui_str': 'Strength of cough (observable entity)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",40.0,0.314659,"SAPB was associated with improved NRS pain scores at rest, with cough and with movement at 24-hours postoperatively (p=0.007, p=0.001 and p=0.012 respectively).","[{'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Hanley', 'Affiliation': 'Department of Anaesthesia, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wall', 'Affiliation': 'Department of Anaesthesia, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Irmina', 'Initials': 'I', 'LastName': 'Bukowska', 'Affiliation': 'Department of Anaesthesia, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Cardiothoracic Surgery, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Eaton', 'Affiliation': 'Department of Cardiothoracic Surgery, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Róisín', 'Initials': 'R', 'LastName': 'Ní Mhuircheartaigh', 'Affiliation': 'Department of Anaesthesia, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Hearty', 'Affiliation': 'Department of Anaesthesia, Mater Misericordiae University Hospital, Dublin, Ireland.'}]","European journal of pain (London, England)",['10.1002/ejp.1533']
336,32074335,Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life.,"INTRODUCTION


Calmare Scrambler Therapy (ST) interferes with pain signal transmission by using nerve fibers to convey a message of normality to the central nervous system. This prospective, double-blinded, randomized trial had three aims. First, we tried to determine ST's effectiveness in reducing chronic neuropathic pain symptoms and analgesic medication use in military service members, when compared to sham treatment. Next, we examined its effect on reported mental and physical health-related quality of life. Finally, we sought to describe participant perceptions of treatment effectiveness.
MATERIALS AND METHODS


Forty-seven subjects were randomized to receive ten 30-minute active ST or sham treatments. Data were collected at baseline, posttreatment, and 1-month follow-up.
RESULTS


The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment. However, both produced clinically meaningful reductions in pain and improvements in physical health-related quality posttreatment that was sustained at 1-month follow-up. Ninety percent of the blinded sample described the treatment intervention as a partial or complete success.
CONCLUSION


ST is no better than sham treatment in decreasing pain. Yet, patient perceptions of treatment effectiveness are equally important in chronic pain treatment.",2020,"The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment.","['Forty-seven subjects', 'military service members']","['Scrambler Therapy Treatment', 'Calmare Scrambler Therapy (ST']","['Chronic Pain and Quality of Life', 'mental and physical health-related quality of life', 'physical health-related quality posttreatment', 'chronic neuropathic pain symptoms', 'pain scores, medication use, or mental or physical health-related quality of life', 'pain']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",47.0,0.189021,"The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment.","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Nayback-Beebe', 'Affiliation': 'U.S. Army Medical Research & Materiel Command, 810 Schreider St., Fort Detrick, MD 21702.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Panula', 'Affiliation': 'U.S. Army Medical Command, 2271 Reynolds Road, Bldg. 4025, Fort Sam Houston, TX 78234.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Arzola', 'Affiliation': 'The Geneva Foundation, 917 Pacific Ave, Tacoma, WA 98402.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Goff', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Fort Sam Houston, TX 78234.'}]",Military medicine,['10.1093/milmed/usz253']
337,31802233,A single paravertebral injection via a needle vs. a catheter for the spreading to multiple intercostal levels: a randomized controlled trial.,"PURPOSE


Thoracic paravertebral block (TPVB) provides a unilateral nerve block at multiple intercostal levels allowing injection of a local anesthetic into paravertebral space (PVS) via a needle or catheter. However, the most effective injection method remains unclear. This study compared the real-time spread of ropivacaine between two paravertebral injection methods using thoracoscopy.
METHODS


Thirty-four patients scheduled for thoracoscopic surgery were randomly allocated into the Needle or Catheter groups, and performed transverse in-plane ultrasound-guided TPVB. The Needle group received 20 ml of 0.5% ropivacaine via a needle placed into the lateral edge of PVS; the Catheter group received the same dose of ropivacaine via a catheter inserted 5 cm into PVS. The primary outcome was the spreading pattern of ropivacaine in each group. The secondary outcome was intraoperative vasopressor requirement after paravertebral injection.
RESULTS


In the Needle group, all cases showed ropivacaine spread to multiple intercostal levels, mainly across the ribs. Contrastingly, the Catheter group showed variable spreading patterns; multiple intercostal levels (n = 10) [across the ribs (n = 4), anterolateral aspect of the vertebral bodies (n = 6)] or unobservable spreading (no change; n = 7) (P = 0.007). Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
CONCLUSION


Paravertebral injection via a needle typically resulted in spreading to multiple intercostal levels, especially across the ribs on the peripheral side of injection site, whereas injection via a catheter resulted in variable spreading patterns. Therefore, injections via needles are more stable.",2020,"Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
",['Thirty-four patients scheduled for thoracoscopic surgery'],"['ropivacaine', 'Thoracic paravertebral block (TPVB', '20\xa0ml of 0.5% ropivacaine', 'ropivacaine via a catheter inserted 5\xa0cm into PVS', 'Needle or Catheter groups, and performed transverse in-plane ultrasound-guided TPVB']","['unobservable spreading', 'spreading pattern of ropivacaine', 'anterolateral aspect of the vertebral bodies', 'intraoperative vasopressor requirement after paravertebral injection', 'variable spreading patterns; multiple intercostal levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",34.0,0.036128,"Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Surgical Center, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ban', 'Affiliation': 'Department of Anesthesiology, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shitaokoshi', 'Affiliation': 'Department of Anesthesiology, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan. nishi@med.nagoya-u.ac.jp.'}]",Journal of anesthesia,['10.1007/s00540-019-02713-6']
338,32200824,The Herpetic Eye Disease Study: Topical Corticosteroid Trial for Herpes Simplex Stromal Keratitis: A Paradigm Shifting Clinical Trial.,,2020,,['Herpes Simplex Stromal Keratitis'],[],[],"[{'cui': 'C1318020', 'cui_str': 'Stromal keratitis'}]",[],[],,0.420951,,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chodosh', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.09.044']
339,32200827,Herpetic Eye Disease Study: A Controlled Trial of Topical Corticosteroids for Herpes Simplex Stromal Keratitis.,"PURPOSE


To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis.
METHODS


The authors performed a randomized, double-masked, placebo-con- trolled, multicenter clinical trial of 106 patients with active herpes simplex stromal keratitis who had not received any corticosteroids for at least 10 days before study enrollment. Patients were assigned to the placebo group (n = 49) or the steroid group (topical prednisolone phosphate; n = 57); both regimens were tapered over 10 weeks. Both groups received topical trifluridine. Visual acuity assessment and slit-lamp biomicroscopy were performed weekly for 10 weeks, every other week for an additional 6 weeks or until removal from the trial, and at 6 months after randomization.
RESULTS


The time to treatment failure (defined by specific criteria as persistent or progressive stromal keratouveitis or an adverse event) was significantly longer in the steroid group compared with the placebo group. Compared with placebo, corticosteroid therapy reduced the risk of persistent or progressive stromal keratouveitis by 68%. The time from randomization to resolution of stromal keratitis and uveitis was significantly shorter in the steroid group compared with the placebo group even though both groups included patients who were removed from the study and treated with topical corticosteroids according to best medical judgment. Nineteen (33%) of the steroid-treated patients and 11 (22%) of the placebo-treated patients completed the 10 weeks of protocol therapy and had stable, noninflamed corneas after 16 weeks. At 6 months after randomization, no clinically or statistically significant differences in visual outcome or recurrent herpetic eye disease were identified between the steroid and placebo groups.
CONCLUSIONS


The topical corticosteroid regimen used in this study was significantly better than placebo in reducing persistence or progression of stromal inflammation and in shortening the duration of herpes simplex stromal keratitis. Postponing steroids during careful observation for a few weeks delayed resolution of stromal keratitis but had no detrimental effect as assessed by visual outcome at 6 months.",2020,"At 6 months after randomization, no clinically or statistically significant differences in visual outcome or recurrent herpetic eye disease were identified between the steroid and placebo groups.
","['Herpetic Eye Disease Study', 'Herpes Simplex Stromal Keratitis', '106 patients with active herpes simplex stromal keratitis who had not received any corticosteroids for at least 10 days before study enrollment']","['placebo-con- trolled', 'placebo', 'Topical Corticosteroids', 'placebo, corticosteroid therapy', 'topical trifluridine', 'topical corticosteroids', 'steroid group (topical prednisolone phosphate']","['risk of persistent or progressive stromal keratouveitis', 'duration of herpes simplex stromal keratitis', 'Visual acuity assessment and slit-lamp biomicroscopy', 'persistence or progression of stromal inflammation', 'time to treatment failure', 'progressive stromal keratouveitis or an adverse event', 'stromal keratitis and uveitis', 'visual outcome or recurrent herpetic eye disease']","[{'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1318020', 'cui_str': 'Stromal keratitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1301533', 'cui_str': 'Herpes simplex stromal keratitis'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0071842', 'cui_str': 'prednisolone phosphate'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1299910', 'cui_str': 'Keratouveitis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1318020', 'cui_str': 'Stromal keratitis'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0419360', 'cui_str': 'Slit Lamp Examination'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}]",106.0,0.743302,"At 6 months after randomization, no clinically or statistically significant differences in visual outcome or recurrent herpetic eye disease were identified between the steroid and placebo groups.
","[{'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Wilhelmus', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Gee', 'Affiliation': ''}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'Hauck', 'Affiliation': ''}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Kurinij', 'Affiliation': ''}, {'ForeName': 'Chandler R', 'Initials': 'CR', 'LastName': 'Dawson', 'Affiliation': ''}, {'ForeName': 'Dan B', 'Initials': 'DB', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Barron', 'Affiliation': ''}, {'ForeName': 'Herbert E', 'Initials': 'HE', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Sugar', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hyndiuk', 'Affiliation': ''}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Laibson', 'Affiliation': ''}, {'ForeName': 'R Doyle', 'Initials': 'RD', 'LastName': 'Stulting', 'Affiliation': ''}, {'ForeName': 'Penny A', 'Initials': 'PA', 'LastName': 'Asbell', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.01.037']
340,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
341,31836474,Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT).,"BACKGROUND AND AIMS


Adenoma miss rate during colonoscopy is directly linked to risk of postcolonoscopy colorectal cancer. One of the reasons for missed adenomas is poor visualization of proximal folds during standard colonoscopy withdrawal. Disposable distal attachments such as the plastic cap and Endocuff (Arc Medical Design, Leeds, UK) that hold back folds appear to improve adenoma detection. The primary aim of this study was to compare adenoma detection rates between Endocuff-assisted colonoscopy (EAC) and cap-assisted colonoscopy (CAC).
METHODS


This is a randomized, single-center, tandem colonoscopy trial performed by the same endoscopists on the same day, first with Endocuff Vision (Arc Medical Design, Leeds, UK) followed by cap or vice versa. All procedures were performed by 3 experienced gastroenterology fellows.
RESULTS


One hundred fifty-four patients were recruited. Seventy-eight (50.6%) had CAC as their first procedure. Mean patient age was 61 years (male-to-female ratio, 1:1). Adenoma detection rate was significantly higher for EAC when compared to CAC (53% vs 26%, P = .001). Polyp miss rate was significantly lower in EAC (8.4%) compared with CAC (26.1%, P < .001) as was adenoma miss rate (EAC vs CAC, 6%, vs 19%; P = .002) and diminutive adenoma (<5 mm) miss rate in the EAC group (1.8% vs 19.6%, P < .001). However, there was no significant differences in the miss rates for small adenomas (5-9 mm) (3.7% vs 2.9%, P = .69) or adenomas 10 mm or larger (1.6% vs 2.6%, P = .98 ). The mean number of adenomas per procedure was significantly higher with EAC compared with CAC (1.5 vs .8, P < .001). Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01). Conversely, withdrawal time (median 10 vs 8 minutes, P = .01) was significantly longer in EAC.
CONCLUSIONS


This randomized, tandem study demonstrates that EAC has a significantly higher adenoma detection rate and lower adenoma miss rate than CAC. Although insertion times were shorter with EAC, procedures were slightly more uncomfortable, and the cuff had to be removed in a small number of cases. (Clinical trial registration number: NCT03254498.).",2020,"Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01).","['One hundred fifty-four patients were recruited', 'adenoma detection', 'Mean patient age was 61 years (male-to-female ratio, 1:1']","['Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy', 'EAC', 'Endocuff-assisted colonoscopy (EAC) and cap-assisted colonoscopy (CAC']","['mean number of adenomas per procedure', 'diminutive adenoma', 'Cecal intubation time', 'adenoma detection rate', 'Polyp miss rate', 'adenoma detection rates', 'miss rates for small adenomas', 'Adenoma detection rate', 'adenoma miss rate', 'withdrawal time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",154.0,0.106835,"Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01).","[{'ForeName': 'Rajaratnam', 'Initials': 'R', 'LastName': 'Rameshshanker', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK; Department of Surgery and Cancer, Imperial College, London, UK.""}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Tsiamoulos', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Rajendran', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statconsultancy Ltd, Amersham, UK.'}, {'ForeName': 'Paris', 'Initials': 'P', 'LastName': 'Tekkis', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Saunders', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.046']
342,32200813,Ranibizumab and Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration: Two-Year Results.,"OBJECTIVE


To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment.
DESIGN


Multicenter, randomized clinical trial.
PARTICIPANTS


Patients (n = 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial.
INTERVENTIONS


At enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment.
MAIN OUTCOME MEASURES


Mean change in visual acuity.
RESULTS


Among patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference, -1.4 letters; 95% confidence interval [CI], -3.7 to 0.8; P = 0.21). Mean gain was greater for monthly than for as-needed treatment (difference, -2.4 letters; 95% CI, -4.8 to -0.1; P = 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P = 0.0003; regimen, P < 0.0001). Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (-2.2 letters; P = 0.03) and a lower proportion without fluid (-19%; P < 0.0001). Rates of death and arteriothrombotic events were similar for both drugs (P > 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P = 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF).
CONCLUSIONS


Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment. There were no differences between drugs in rates of death or arteriothrombotic events. The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF.
FINANCIAL DISCLOSURE(S)


Proprietary or commercial disclosure may be found after the references.",2020,"Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment.","['Patients (n\xa0= 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial', 'Neovascular Age-related Macular Degeneration']","['ranibizumab and bevacizumab', 'drug (ranibizumab or bevacizumab', 'Ranibizumab and bevacizumab', 'bevacizumab', 'ranibizumab', 'Ranibizumab and Bevacizumab']","['gain in visual acuity', 'proportion of patients with 1 or more systemic serious adverse events', 'Mean change in visual acuity', 'mean gain in visual acuity', 'vision', 'Rates of death and arteriothrombotic events', 'rates of death or arteriothrombotic events', 'Mean gain', 'visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1185.0,0.539915,"Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stuart L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Ophthalmology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Grunwald', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Toth', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Maryann', 'Initials': 'M', 'LastName': 'Redford', 'Affiliation': 'National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Ferris', 'Affiliation': 'National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.029']
343,32200814,The Collaborative Ocular Melanoma Study Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma.,,2020,,['Choroidal Melanoma'],['Iodine 125 Brachytherapy'],[],"[{'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0454096', 'cui_str': 'Iodine 125 brachytherapy (procedure)'}]",[],,0.146539,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Salowe', 'Affiliation': ''}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': ""O'Brien"", 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.09.047']
344,32200815,The COMS Randomized Trial of Iodine 125 Brachytherapy for Choroidal Melanoma: IV. Local Treatment Failure and Enucleation in the First 5 Years after Brachytherapy. COMS Report No. 19.,"OBJECTIVE


To describe the frequency and predictors of local treatment failure and enucleation after iodine 125 (I 125 ) brachytherapy in patients with choroidal melanoma treated and followed up in a large randomized clinical trial.
DESIGN


Prospective, noncomparative, interventional case series within a randomized, multicenter clinical trial.
PARTICIPANTS


Patients enrolled in the Collaborative Ocular Melanoma Study (COMS) trial of enucleation versus brachytherapy between February 1987 and July 1998; tumors measured 2.5 to 10.0 mm in apical height and no more than 16.0 mm in longest basal dimension.
METHODS


I 125  brachytherapy was administered via episcleral plaque according to a standard protocol. Follow-up ophthalmic evaluations, including ophthalmic ultrasound and fundus photography, were performed according to a standard protocol at baseline, every 6 months thereafter for 5 years, and subsequently at annual intervals. Survival analysis methods were used to estimate the cumulative risk of postirradiation treatment failure and enucleation. Factors associated with treatment failure and enucleation of plaqued eyes were evaluated using Cox proportional hazards analysis.
MAIN OUTCOME MEASURES


Reports of enucleation and of local treatment failure, defined as tumor growth, recurrence, or extrascleral extension, derived from clinical reports based on echographic and photographic documentation.
RESULTS


As of September 30, 2000, 638 of the 650 patients randomized to brachytherapy and so treated had been followed up for 1 year or longer, and 411 had been followed up for at least 5 years. Sixty-nine eyes were enucleated during the first 5 years after brachytherapy, and treatment failure was reported for 57 eyes. The Kaplan-Meier estimate of proportion of patients undergoing enucleation by 5 years was 12.5% (95% confidence interval [CI], 10.0%-15.6%); the risk of treatment failure was 10.3% (95% CI, 8.0%-13.2%). Treatment failure was the most common reason for enucleation within 3 years of treatment; beyond 3 years, ocular pain was most common. Risk factors for enucleation were greater tumor thickness, closer proximity of the posterior tumor border to the foveal avascular zone, and poorer baseline visual acuity in the affected eye. Risk factors for treatment failure were older age, greater tumor thickness, and proximity of the tumor to the foveal avascular zone. Local treatment failure was associated weakly with reduced survival after controlling for baseline tumor and personal characteristics (adjusted risk ratio, 1.5; P = 0.08).
CONCLUSIONS


Local treatment failure and enucleation were relatively infrequent events after I 125  brachytherapy within the COMS. Treatment failure typically occurred early and was associated weakly with poorer survival. The COMS randomized trial documented the absence of a clinically or statistically significant difference in survival for patients randomly assigned to enucleation versus brachytherapy. This analysis documents the efficacy of brachytherapy to achieve sustained local tumor control and to conserve the globe.",2020,"Treatment failure was the most common reason for enucleation within 3 years of treatment; beyond 3 years, ocular pain was most common.","['As of September 30, 2000, 638 of the 650 patients randomized to', 'Choroidal Melanoma', 'Patients enrolled in the Collaborative Ocular Melanoma Study (COMS) trial of enucleation versus brachytherapy between February 1987 and July 1998; tumors measured 2.5 to 10.0 mm in apical height and no more than 16.0 mm in longest basal dimension', 'patients with choroidal melanoma treated and followed up in a large randomized clinical trial', 'I']","['ophthalmic ultrasound and fundus photography', 'Iodine 125 Brachytherapy', '125  brachytherapy', 'enucleation versus brachytherapy', 'brachytherapy', 'iodine 125 (I 125 ) brachytherapy']","['reduced survival', 'survival', 'risk of treatment failure', 'baseline visual acuity', 'ocular pain', 'poorer survival']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0558356', 'cui_str': 'Malignant melanoma of eye (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography (procedure)'}, {'cui': 'C0454096', 'cui_str': 'Iodine 125 brachytherapy (procedure)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0151827', 'cui_str': 'Eye pain'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",650.0,0.180766,"Treatment failure was the most common reason for enucleation within 3 years of treatment; beyond 3 years, ocular pain was most common.","[{'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Department of Ophthalmology, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Claudia S', 'Initials': 'CS', 'LastName': 'Moy', 'Affiliation': 'Wilmer Ophthalmological Institute, Johns Hopkins School of Medicine, Baltimore, Maryland; Current affiliation: National Institutes of Health/NINDS, Bethesda, Maryland. Electronic address: cm384s@nih.gov.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Murray', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Reynolds', 'Affiliation': 'Wilmer Ophthalmological Institute, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Albert', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Schachat', 'Affiliation': 'Wilmer Ophthalmological Institute, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Diddie', 'Affiliation': 'Doheny Eye Institute, University of Southern California School of Medicine, Los Angeles, California.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Engstrom', 'Affiliation': 'Jules Stein Eye Institute, University of California Los Angeles Medical Center, Los Angeles, California.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Finger', 'Affiliation': 'NewYork Eye Cancer Center, NewYork, NewYork.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Hovland', 'Affiliation': 'Porter Adventist Hospital, Denver, Colorado.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Joffe', 'Affiliation': 'Retina Associates Southwest, Tucson, Arizona.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Olsen', 'Affiliation': 'Retina-Vitreous Consultants, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Wells', 'Affiliation': 'Department of Ophthalmology, University of Washington, Seattle, Washington.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.01.032']
345,32200817,"A Prospective, Randomized, Double-blind, Placebo-controlled Study of Orbital Radiotherapy for Graves' Ophthalmopathy.","CONTEXT


Although widely used for more than 85 years, the efficacy of radiotherapy for Graves' ophthalmopathy (GO) has not been established convincingly.
OBJECTIVE


To evaluate the efficacy of radiotherapy for GO.
DESIGN


Prospective, randomized, internally controlled, double-blind clinical trial in a tertiary care academic medical center.
PARTICIPANTS


The patients were ethnically diverse males and females over age 30 seen in a referral practice. The patients had moderate, symptomatic Graves' ophthalmopathy (mean clinical activity score, 6.2) but no optic neuropathy, diabetes, recent steroid treatment, previous decompression, or muscle surgery. Forty-two of 53 consecutive patients were enrolled after giving informed consent and fulfilling study entry criteria. Eleven eligible patients declined to participate because of inconvenience, desire for alternative therapy, or concern about radiation.
INTERVENTION


One randomly selected orbit was treated with 20 Gy of external beam therapy; sham therapy was given to the other side. Six months later, the therapies were reversed.
MAIN OUTCOME MEASURES


Every 3 months for 1 year, we measured the volume of extraocular muscle and fat, proptosis, range of extraocular muscle motion, area of diplopia fields, and lid fissure width. Effective treatment for GO will modify one or more of these parameters.
RESULTS


No clinically or statistically significant difference between the treated and untreated orbit was observed in any of the main outcome measures at 6 months. At 12 months, muscle volume and proptosis improved slightly more in the orbit that was treated first.
CONCLUSIONS


In this group of patients, representative of those for whom radiotherapy is frequently recommended, we were unable to demonstrate any beneficial therapeutic effect. The slight improvement noted in both orbits at 12 months may be the result of natural remission or of radiotherapy, but the changes are of marginal clinical significance.",2020,No clinically or statistically significant difference between the treated and untreated orbit was observed in any of the main outcome measures at 6 months.,"[""Graves' Ophthalmopathy"", 'tertiary care academic medical center', 'Forty-two of 53 consecutive patients were enrolled after giving informed consent and fulfilling study entry criteria', 'Eleven eligible patients declined to participate because of inconvenience, desire for alternative therapy, or concern about radiation', ""patients had moderate, symptomatic Graves' ophthalmopathy (mean clinical activity score, 6.2) but no optic neuropathy, diabetes, recent steroid treatment, previous decompression, or muscle surgery"", 'patients were ethnically diverse males and females over age 30 seen in a referral practice']","['Orbital Radiotherapy', 'Placebo', '20 Gy of external beam therapy; sham therapy', 'radiotherapy']","['volume of extraocular muscle and fat, proptosis, range of extraocular muscle motion, area of diplopia fields, and lid fissure width', 'muscle volume and proptosis']","[{'cui': 'C0339143', 'cui_str': 'Graves Ophthalmopathy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0949216', 'cui_str': 'Alternative Therapies'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C3887709'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0699036', 'cui_str': 'Orbital (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0028863', 'cui_str': 'Extraocular Muscles'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015300', 'cui_str': 'Proptosis'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0332469', 'cui_str': 'Fissured (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",1.0,0.045838,No clinically or statistically significant difference between the treated and untreated orbit was observed in any of the main outcome measures at 6 months.,"[{'ForeName': 'Colum A', 'Initials': 'CA', 'LastName': 'Gorman', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, Minnesota. Electronic address: gorman.colum@mayo.edu.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Garrity', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Vahab', 'Initials': 'V', 'LastName': 'Fatourechi', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Bahn', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ivy A', 'Initials': 'IA', 'LastName': 'Petersen', 'Affiliation': 'Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Stafford', 'Affiliation': 'Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Earle', 'Affiliation': 'Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Forbes', 'Affiliation': 'Diagnostic Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Kline', 'Affiliation': 'Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Bergstralh', 'Affiliation': 'Section of Biostatistics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Offord', 'Affiliation': 'Section of Biostatistics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Rademacher', 'Affiliation': 'Section of Biostatistics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Stanley', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Bartley', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.031']
346,32200818,The Optic Neuritis Treatment Trial.,,2020,,[],[],[],[],[],[],,0.0193924,,"[{'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Newman', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.09.046']
347,31029650,"Nutrient Intake, Diet Quality, and Diet Diversity in Irritable Bowel Syndrome and the Impact of the Low FODMAP Diet.","BACKGROUND


Individuals with irritable bowel syndrome (IBS) may modify their diet, which may pose nutritional risk. Further, some dietary approaches, such as a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), are restrictive and may contribute to nutritional inadequacy.
OBJECTIVE


Our aim was to evaluate habitual nutrient intake, diet quality, and diversity in IBS and the effect of a 4-week low FODMAP diet on these parameters compared with controls.
DESIGN


Data from two randomized controlled trials were included for this secondary analysis. Participants were randomized to low FODMAP diet (n=63) or control diet (sham diet n=48, habitual diet n=19).
PARTICIPANTS/SETTING


Participants included 130 individuals with IBS referred to a tertiary center in London, UK between January 2010 to June 2011 and January 2013 to November 2014.
INTERVENTION


Participants in one trial were randomized to receive either low FODMAP dietary counseling or sham control dietary counseling. In the other, they were randomized to receive low FODMAP dietary counseling or to continue habitual diet. All advice was provided by a specialist dietitian.
MAIN OUTCOME MEASURES


Habitual (usual) dietary intake at baseline (n=130) and after a 4-week intervention period was measured using 7-day food records.
STATISTICAL ANALYSES PERFORMED


Analysis of covariance and χ 2  tests evaluated differences across groups at 4 weeks.
RESULTS


When examining habitual intake of individuals with IBS, fiber intake was low, with only 6 (5%) achieving the target (30 g/day). In those receiving low FODMAP advice, there was no difference in intake of most nutrients compared with controls. However, there was lower intake of starch (109 g/day) vs habitual control diet (128 g/day; P=0.030), and higher intake of vitamin B-12 (6.1 μg/day) vs habitual (3.9 μg/day) and sham control diets (4.7 μg/day; P<0.01). Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01).
CONCLUSION


This study demonstrates many individuals with IBS fail to meet dietary reference values for multiple nutrients. A 4-week low FODMAP diet, when delivered by a specialist dietitian, does not impact on intake of most nutrients or diet diversity but decreases diet quality compared with control diets.",2020,"Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01).
","['Participants included 130 individuals with IBS referred to a tertiary center in London, UK between January 2010 to June 2011 and January 2013 to November\xa02014', 'Individuals with irritable bowel syndrome (IBS']","['low FODMAP diet', 'low FODMAP dietary counseling or sham control dietary counseling', 'low FODMAP dietary counseling', '4-week low FODMAP diet', 'control diet (sham diet n=48, habitual diet n=19']","['higher intake of vitamin B-12', 'intake of most nutrients', 'diet quality', 'Nutrient Intake, Diet Quality, and Diet Diversity', 'Habitual (usual) dietary intake', 'habitual nutrient intake, diet quality, and diversity in IBS', 'Overall scores for diet quality', 'lower intake of starch']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]",130.0,0.0558268,"Overall scores for diet quality were lower after low FODMAP advice vs habitual control diet (P<0.01).
","[{'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Staudacher', 'Affiliation': ''}, {'ForeName': 'Frances S E', 'Initials': 'FSE', 'LastName': 'Ralph', 'Affiliation': ''}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ''}, {'ForeName': 'Miranda C E', 'Initials': 'MCE', 'LastName': 'Lomer', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.01.017']
348,31811562,Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial.,"BACKGROUND


Apheresis therapy involves the selective removal of leukocytes and is used to induce remission in ulcerative colitis (UC) patients. The aim of this study was to demonstrate the efficacy and safety of apheresis therapy for maintaining UC remission.
METHODS


We conducted a multicenter, prospective, randomised-control trial of patients with remitting UC induced by granulocyte and monocyte adsorption apheresis or leukocytapheresis. Patients were randomly assigned to the apheresis group (twice per month for 12 months) or the control group (no apheresis treatment) using a 1:1 allocation ratio. The primary endpoint was the rate of cumulative clinical remission (Mayo score ≤ 2) at 12 months. The secondary endpoints were the rates of clinical remission, endoscopic remission, and complete endoscopic remission at 12 months.
RESULTS


Between March 2013 and March 2017, 164 patients were enrolled. The cumulative remission rate at 12 months was 46.6% in the apheresis group and 36.4% in the control group (p = 0.1621). The rate of endoscopic remission at 12 months was significantly higher in the apheresis group than in the control group (42.5% vs. 25.9%) p = 0.0480). The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant. No severe adverse events were observed in either group.
CONCLUSIONS


Apheresis was well tolerated as maintenance therapy for UC although the cumulative clinical remission rate at 12 months was comparable between the apheresis and control groups.",2020,"The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant.","['patients with ulcerative colitis', 'ulcerative colitis (UC) patients', 'patients with remitting UC induced by granulocyte and monocyte adsorption apheresis or leukocytapheresis', 'Between March 2013 and March 2017, 164 patients were enrolled']","['apheresis', 'apheresis therapy', 'control group (no apheresis treatment']","['cumulative clinical remission rate', 'complete endoscopic remission', 'rate of cumulative clinical remission (Mayo score\xa0≤\xa02', 'efficacy and safety', 'rate of clinical remission', 'cumulative remission rate', 'severe adverse events', 'rate of endoscopic remission', 'rates of clinical remission, endoscopic remission, and complete endoscopic remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0001674', 'cui_str': 'Adsorption'}, {'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0023416', 'cui_str': 'Leukocytapheresis'}]","[{'cui': 'C0005791', 'cui_str': 'Pheresis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",164.0,0.118355,"The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant.","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Naganuma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. nagamakoto@keio.jp.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Motoya', 'Affiliation': 'Inflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Hokkaido, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Sawada', 'Affiliation': 'Dojima General and Gastroenterology Clinic, Osaka, Japan.'}, {'ForeName': 'Fumito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Inflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'IBD Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hanai', 'Affiliation': 'IBD Center, Hamamatsu South Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': ""Institute of Gastroenterology and Hepatology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Kanai', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastroenterology,['10.1007/s00535-019-01651-0']
349,32202318,Three-year observation of children 12 to 35 months old with untreated intermittent exotropia.,"PURPOSE


To describe the clinical course of untreated intermittent exotropia (IXT) in children 12-35 months of age followed for 3 years.
METHODS


We enrolled 97 children 12-35 months of age with previously untreated IXT who had been randomly assigned to the observation arm of a randomised trial of short-term occlusion versus observation. Participants were observed unless deterioration criteria were met at a follow-up visit occurring at 3 months, 6 months, and 6-month intervals thereafter for 3 years. The primary outcome was deterioration of the IXT by 3 years, defined as (1) a constant exotropia ≥10 prism dioptres (∆) at distance and near (i.e., motor deterioration) or (2) treatment prescribed despite not having met motor deterioration. The primary analysis used the Kaplan-Meier method to determine the cumulative proportion of participants meeting deterioration by three years and 95% confidence interval (CI).
RESULTS


The cumulative probability of deterioration by 3 years was 28% (95% CI = 20%-39%). Of the 24 participants meeting the primary outcome of deterioration, seven met motor deterioration and 17 were prescribed treatment without meeting motor deterioration. The cumulative probability of motor deterioration by 3 years was 10% (95% CI = 5%-19%).
CONCLUSIONS


Given the modest rate of motor deterioration over three years, watchful waiting may be a reasonable management approach in 12- to 35-month-old children with IXT. To confirm this recommendation would require a long-term randomised trial of immediate treatment versus observation followed by deferred treatment if needed.",2020,"The cumulative probability of motor deterioration by 3 years was 10% (95% CI = 5%-19%).
","['24 participants meeting the primary outcome of deterioration, seven met motor deterioration and 17 were prescribed treatment without meeting motor deterioration', '97 children 12-35\xa0months of age with previously untreated IXT who had been randomly assigned to the observation arm of a randomised trial of', 'children 12 to 35 months old with untreated intermittent exotropia', 'children 12-35\xa0months of age followed for 3\xa0years']","['short-term occlusion versus observation', 'untreated intermittent exotropia (IXT']","['deterioration of the IXT by 3\xa0years, defined as (1) a constant exotropia ≥10 prism dioptres (∆) at distance and near (i.e., motor deterioration) or (2) treatment prescribed despite not having met motor deterioration', 'cumulative probability of deterioration', 'cumulative probability of motor deterioration', 'cumulative proportion of participants meeting deterioration']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0423062', 'cui_str': 'Intermittent exotropia (disorder)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015310', 'cui_str': 'Strabismus, Divergent'}, {'cui': 'C0439487', 'cui_str': 'prism diopters'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}]",97.0,0.138407,"The cumulative probability of motor deterioration by 3 years was 10% (95% CI = 5%-19%).
","[{'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry at Marshall B Ketchum University, Fullerton, California, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Mohney', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Chandler', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'B Michele', 'Initials': 'BM', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Superstein', 'Affiliation': 'Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Crouch', 'Affiliation': 'Virginia Pediatric Eye Center, Virginia Beach, Virginia, USA.'}, {'ForeName': 'Evelyn A', 'Initials': 'EA', 'LastName': 'Paysse', 'Affiliation': ""Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12668']
350,31103370,The Impact of a 4-Week Low-FODMAP and mNICE Diet on Nutrient Intake in a Sample of US Adults with Irritable Bowel Syndrome with Diarrhea.,"BACKGROUND


A diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) has gained increasing acceptance for the treatment of irritable bowel syndrome but safety concerns have been raised regarding nutritional adequacy. Changes in nutrient intake during the elimination phase of the low-FODMAP diet remain predominantly unknown.
OBJECTIVE


To determine changes in the mean reported daily nutrient content before and after 4 weeks of a low-FODMAP diet vs modified National Institute for Health and Clinical Excellence (mNICE) dietary intervention and to identify nutritional inadequacies based on comparison to the Dietary Reference Intakes in patients with irritable bowel syndrome-diarrhea subtype.
DESIGN


Post hoc analysis of a randomized controlled trial entailing a 4-week trial period comparing the low-FODMAP and mNICE diets.
PARTICIPANTS AND SETTING


A total of 78 patients (41 low FODMAP and 37 mNICE) meeting the Rome III criteria for irritable bowel syndrome-diarrhea subtype were consecutively recruited from gastroenterology and primary care clinics at the University of Michigan Medical Center between October 2012 and November 2015.
METHODS


Participants randomized to the low-FODMAP arm were instructed to decrease their dietary intake of FODMAPs, whereas participants randomized to the mNICE intervention arm were instructed to eat small frequent meals, avoid trigger foods, and avoid excess alcohol and caffeine.
MAIN OUTCOME MEASURES


Post hoc evaluation for presence of micronutrient deficiencies per Dietary Reference Intakes when implementing low-FODMAP vs mNICE dietary interventions. Dietary intake was analyzed via 3-day food diaries at baseline and during the final week of the assigned diet.
STATISTICAL ANALYSES PERFORMED


A post hoc analysis utilizing either a t test or χ 2  analysis was conducted between before and after data.
RESULTS


Both diets resulted in fewer daily kilocalories consumed, fewer number of daily meals consumed, and less daily carbohydrate intake. Among the patients following the low-FODMAP diet, there was a statistically significant decrease from baseline in several micronutrients, which was not observed in the mNICE cohort. However, these differences in the low-FODMAP group remained significant only for riboflavin after correcting for calorie-adjusted nutrient intake. Comparing Dietary Reference Intakes of participants pre- and postintervention, fewer patients met the Dietary Reference Intakes for thiamin and iron in the low FODMAP group, and for calcium and copper in the mNICE group.
CONCLUSIONS


During a 4-week dietary intervention, the mean daily intake of most micronutrients remained stable and within the Recommended Dietary Allowances for both diets. Although decrease in several micronutrients was observed with implementation of the low-FODMAP diet relative to the mNICE diet, most of these disappeared after adjusting for energy intake.",2020,"Both diets resulted in fewer daily kilocalories consumed, fewer number of daily meals consumed, and less daily carbohydrate intake.","['A total of 78 patients (41 low FODMAP and 37 mNICE) meeting the Rome III criteria for irritable bowel syndrome-diarrhea subtype were consecutively recruited from gastroenterology and primary care clinics at the University of Michigan Medical Center between October 2012 and November\xa02015', 'patients with irritable bowel syndrome-diarrhea subtype', 'Adults with Irritable Bowel Syndrome with Diarrhea', 'participants pre- and postintervention, fewer patients met the Dietary Reference Intakes for thiamin and iron in the low FODMAP group, and for calcium and copper in the mNICE group']","['riboflavin', 'mNICE intervention arm were instructed to eat small frequent meals, avoid trigger foods, and avoid excess alcohol and caffeine', '4-Week Low-FODMAP and mNICE Diet', 'low-FODMAP diet vs modified National Institute for Health and Clinical Excellence (mNICE) dietary intervention', 'low-FODMAP', 'low-FODMAP and mNICE diets']","['Nutrient Intake', 'Dietary intake', 'daily carbohydrate intake']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C2985508', 'cui_str': 'Dietary Reference Intake'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}]","[{'cui': 'C0373720', 'cui_str': 'Vitamin B2'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4552346', 'cui_str': 'FODMAP diet'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",78.0,0.0244793,"Both diets resulted in fewer daily kilocalories consumed, fewer number of daily meals consumed, and less daily carbohydrate intake.","[{'ForeName': 'Shanti', 'Initials': 'S', 'LastName': 'Eswaran', 'Affiliation': ''}, {'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Dolan', 'Affiliation': ''}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Ball', 'Affiliation': ''}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chey', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.03.003']
351,31701308,Comparison of single minimum dose administration of dexmedetomidine and midazolam for prevention of emergence delirium in children: a randomized controlled trial.,"PURPOSE


Emergence delirium (ED) is common in children after sevoflurane anesthesia and should be prevented for patient safety. A prospective, double-blind, randomized, controlled study was performed to compare the efficacy of minimal dosage of midazolam versus dexmedetomidine to prevent ED in children undergoing tonsillectomy.
METHODS


Seventy children aged 24 months to 12 years were allocated to receive midazolam (0.03 mg/kg) or dexmedetomidine (0.3 µg/kg) 5 min before the end of surgery. The incidence and severity of ED were assessed using a four-point scale and the pediatric anesthesia emergence delirium scale, respectively. The emergence time and postoperative pain scores were also evaluated.
RESULTS


The incidence of ED was 31.3% in the midazolam group and 26.5% in the dexmedetomidine group (P = 0.668). The severity of ED was similar in both groups (9.6 ± 5.8 in the midazolam group, vs. 8.1 ± 5.9 in the dexmedetomidine group, P = 0.299). The emergence time was comparable in the two groups [11.0 (8.3-13.8) min in midazolam group vs. 12.0 (10.0-13.5) min in dexmedetomidine group (P = 0.218)]. Postoperative pain score was higher in the midazolam group [0 (0-1)] than in the dexmedetomidine group [0 (0-0)] (P = 0.011).
CONCLUSION


Dexmedetomidine and midazolam at single minimum dosages had equal effectiveness to prevent ED in children without delaying emergence time, when administered at the end of surgery. With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.",2020,"With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.","['children', 'children undergoing tonsillectomy', 'Seventy children aged 24\xa0months to 12\xa0years', 'children after']","['dexmedetomidine', 'midazolam', 'Dexmedetomidine and midazolam', 'sevoflurane anesthesia', 'dexmedetomidine and midazolam']","['emergence time and postoperative pain scores', 'severity of ED', 'Postoperative pain score', 'incidence and severity of ED', 'incidence of ED', 'analgesic effect', 'emergence time', 'postoperative analgesic efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",70.0,0.26482,"With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.","[{'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Yun-Byeong', 'Initials': 'YB', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea. kh.ryu@skku.edu.'}]",Journal of anesthesia,['10.1007/s00540-019-02705-6']
352,32144319,A randomised controlled study shows supplementation of overweight and obese adults with lactobacilli and bifidobacteria reduces bodyweight and improves well-being.,"In an exploratory, block-randomised, parallel, double-blind, single-centre, placebo-controlled superiority study (ISRCTN12562026, funded by Cultech Ltd), 220 Bulgarian participants (30 to 65 years old) with BMI 25-34.9 kg/m 2  received Lab4P probiotic (50 billion/day) or a matched placebo for 6 months. Participants maintained their normal diet and lifestyle. Primary outcomes were changes in body weight, BMI, waist circumference (WC), waist-to-height ratio (WtHR), blood pressure and plasma lipids. Secondary outcomes were changes in plasma C-reactive protein (CRP), the diversity of the faecal microbiota, quality of life (QoL) assessments and the incidence of upper respiratory tract infection (URTI). Significant between group decreases in body weight (1.3 kg, p < 0.0001), BMI (0.045 kg/m 2 , p < 0.0001), WC (0.94 cm, p < 0.0001) and WtHR (0.006, p < 0.0001) were in favour of the probiotic. Stratification identified greater body weight reductions in overweight subjects (1.88%, p < 0.0001) and in females (1.62%, p = 0.0005). Greatest weight losses were among probiotic hypercholesterolaemic participants (-2.5%, p < 0.0001) alongside a significant between group reduction in small dense LDL-cholesterol (0.2 mmol/L, p = 0.0241). Improvements in QoL and the incidence rate ratio of URTI (0.60, p < 0.0001) were recorded for the probiotic group. No adverse events were recorded. Six months supplementation with Lab4P probiotic resulted in significant weight reduction and improved small dense low-density lipoprotein-cholesterol (sdLDL-C) profiles, QoL and URTI incidence outcomes in overweight/obese individuals.",2020,"Improvements in QoL and the incidence rate ratio of URTI (0.60, p < 0.0001) were recorded for the probiotic group.","['220 Bulgarian participants (30 to 65 years old) with BMI 25-34.9\u2009kg/m 2  received', 'overweight and obese adults with']","['Lab4P probiotic (50 billion/day) or a matched placebo', 'lactobacilli and bifidobacteria', 'Lab4P probiotic']","['body weight', 'body weight reductions', 'Greatest weight losses', 'adverse events', 'weight reduction and improved small dense low-density lipoprotein-cholesterol (sdLDL-C) profiles, QoL and URTI incidence outcomes', 'WtHR', 'changes in plasma C-reactive protein (CRP), the diversity of the faecal microbiota, quality of life (QoL) assessments and the incidence of upper respiratory tract infection (URTI', 'BMI', 'QoL and the incidence rate ratio of URTI', 'small dense LDL-cholesterol', 'changes in body weight, BMI, waist circumference (WC), waist-to-height ratio (WtHR), blood pressure and plasma lipids']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0337798', 'cui_str': 'Bulgarian (ethnic group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}]",220.0,0.245727,"Improvements in QoL and the incidence rate ratio of URTI (0.60, p < 0.0001) were recorded for the probiotic group.","[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Michael', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom. darynm@cultech.co.uk.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Jack', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Masetti', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Davies', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Loxley', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kerry-Smith', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Plummer', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Marchesi', 'Affiliation': 'School of Biosciences, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Mullish', 'Affiliation': 'Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'J A K', 'Initials': 'JAK', 'LastName': 'McDonald', 'Affiliation': 'MRC Centre for Molecular Bacteriology and Infection, Imperial College London, London, United Kingdom.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Hughes', 'Affiliation': 'Systems Immunity Research Institute, Henry Welcome Building, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Garaiova', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Paduchová', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Muchová', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Good', 'Affiliation': 'School of Psychology, Tower building, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Plummer', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}]",Scientific reports,['10.1038/s41598-020-60991-7']
353,32164687,Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol.,"BACKGROUND


Multimodal prehabilitation is a preoperative intervention with the objective to enhance cancer patients' functional status which has been showed to reduce both postoperative morbidity and hospital length of stay in digestive oncologic surgery. However, in lung cancer surgery patients further studies with higher methodological quality are needed to clarify the benefits of prehabilitation. The main aim of the current protocol is to evaluate the cost-effectiveness of a multimodal prehabilitation program supported by information and communication technologies in moderate-to-high risk lung cancer patients undergoing thoracic surgery.
METHODS


A Quadruple Aim approach will be adopted, assessing the prehabilitation program at the following levels: i) Patients' and professionals' experience outcomes (by means of standardized questionnaires, focus groups and structured interviews); ii) Population health-based outcomes (e.g. hospital length of stay, number and severity of postoperative complications, peak oxygen uptake and levels of systemic inflammation); and, iii) Healthcare costs.
DISCUSSION


This study protocol should contribute not only to increase the scientific basis on prehabilitation but also to detect the main factors modulating service adoption.
TRIAL REGISTRATION


NCT04052100 (August 9, 2019).",2020,"Healthcare costs.
","['moderate-to-high risk lung cancer patients undergoing thoracic surgery', 'lung cancer surgery patients', 'moderate-to-high risk patients undergoing lung cancer resection']","['technology-supported multimodal prehabilitation program', 'multimodal prehabilitation program supported by information and communication technologies']","['Cost-effectiveness', 'Population health-based outcomes (e.g. hospital length of stay, number and severity of postoperative complications, peak oxygen uptake and levels of systemic inflammation); and, iii', 'cost-effectiveness']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0471076,"Healthcare costs.
","[{'ForeName': 'Anael', 'Initials': 'A', 'LastName': 'Barberan-Garcia', 'Affiliation': 'Respiratory Medicine Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain. anbarber@clinic.cat.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Navarro-Ripoll', 'Affiliation': 'Anaesthesia and Intensive Care Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sánchez-Lorente', 'Affiliation': 'Thoracic Surgery Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moisés-Lafuente', 'Affiliation': 'Respiratory Medicine Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': 'Thoracic Surgery Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Messaggi-Sartor', 'Affiliation': 'Respiratory Medicine Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'González-Vallespí', 'Affiliation': 'Clinical Psychology Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Montané-Muntané', 'Affiliation': 'Anaesthesia and Intensive Care Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Alsina-Restoy', 'Affiliation': 'Respiratory Medicine Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Campero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Lopez-Baamonde', 'Affiliation': 'Anaesthesia and Intensive Care Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Romano-Andrioni', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rudith', 'Initials': 'R', 'LastName': 'Guzmán', 'Affiliation': 'Thoracic Surgery Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'López', 'Affiliation': 'Anaesthesia and Intensive Care Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Arguis', 'Affiliation': 'Anaesthesia and Intensive Care Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Roca', 'Affiliation': 'Respiratory Medicine Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Graciela', 'Initials': 'G', 'LastName': 'Martinez-Palli', 'Affiliation': 'August Pi i Sunyer Biomedical Research Institute - IDIBAPS, University of Barcelona (UB), Barcelona, Spain.'}]",BMC health services research,['10.1186/s12913-020-05078-9']
354,32144336,Randomized Clinical Trial investigating Self-Assembling Peptide P 11 -4 for Treatment of Early Occlusal Caries.,"Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P 11 -4 (SAP P 11 -4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standard-controlled clinical trial. Test Group 1 received SAP P 11 -4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P 11 -4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish on baseline and Day 180. Caries progression was measured by laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments. Laser fluorescence changes demonstrated superior results for Test Group 1 and 2, as values decreased compared to an increase for the Control Group (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002). This trial showed that SAP P 11 -4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone.",2020,"Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002).","['Ninety children and adolescents', 'non-cavitated occlusal caries', 'Early Occlusal Caries']","['SAP P 11 -4 and twice\xa0fluoride varnish', 'Self-Assembling Peptide P 11 -4', 'fluoride varnish', 'monomeric self-assembling peptide P 11 -4 (SAP P 11 -4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM', 'SAP P 11 -4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish']","['Caries progression', 'partial progression', 'laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0069877', 'cui_str': 'P 11 (pharmaceutical)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1099798', 'cui_str': 'peptide P glycosylase'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",90.0,0.0277162,"Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002).","[{'ForeName': 'Dafina', 'Initials': 'D', 'LastName': 'Doberdoli', 'Affiliation': 'Department of Pediatric Dentistry and Prevention, University Dentistry Clinical Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo. dafina913@gmail.com.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Bommer', 'Affiliation': 'credentis ag, Dorfstrasse 69, 5210, Windisch, Switzerland.'}, {'ForeName': 'Agim', 'Initials': 'A', 'LastName': 'Begzati', 'Affiliation': 'Department of Pediatric Dentistry and Prevention, University Dentistry Clinical Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo.'}, {'ForeName': 'Fehim', 'Initials': 'F', 'LastName': 'Haliti', 'Affiliation': 'Department of Pediatric Dentistry and Prevention, University Dentistry Clinical Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Heinzel-Gutenbrunner', 'Affiliation': 'MH Statistics, 35041, Marburg, Germany.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Juric', 'Affiliation': 'School of Dental Medicine - Department of Pediatric Dentistry and Prevntion, University of Zagreb, Gundulićeva 5, Zagreb, 10000, Croatia.'}]",Scientific reports,['10.1038/s41598-020-60815-8']
355,32069857,Effect of High Versus Low Carbohydrate Intake in the Morning on Glycemic Variability and Glycemic Control Measured by Continuous Blood Glucose Monitoring in Women with Gestational Diabetes Mellitus-A Randomized Crossover Study.,"Carbohydrate is the macronutrient that has the greatest impact on blood glucose response. Limited data are available on how carbohydrate distribution throughout the day affects blood glucose in women with gestational diabetes mellitus (GDM). We aimed to assess how a high-carbohydrate morning-intake (HCM) versus a low-carbohydrate-morning-intake (LCM), affect glycemic variability and glucose control. In this randomized crossover study continuous glucose monitoring (CGM) was performed in 12 women with diet treated GDM (75 g, 2-h OGTT ≥ 8.5 mmol/L), who went through 2 × 3 days of HCM and LCM. A within-subject-analysis showed a significantly higher mean amplitude of glucose excursions (MAGE) (0.7 mmol/L,  p  = 0.004) and coefficient of variation (CV) (5.1%,  p  = 0.01) when comparing HCM with LCM, whereas a significantly lower mean glucose (MG) (-0.3 mmol/L,  p  = 0.002) and fasting blood glucose (FBG) were found (-0.4 mmol/L,  p  = 0.01) on the HCM diet compared to the LCM diet. In addition, insulin resistance, expressed as Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), decreased significantly during HCM. Results indicate that a carbohydrate distribution of 50% in the morning favors lower blood glucose and improvement in insulin sensitivity in women with GDM, but in contrary gives a higher glycemic variability.",2020,"In addition, insulin resistance, expressed as Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), decreased significantly during HCM.","['women with gestational diabetes mellitus (GDM', '12 women with diet treated GDM (75 g, 2-h OGTT ≥ 8.5 mmol/L), who went through 2 × 3 days of', 'women with GDM', 'Women with Gestational Diabetes']","['continuous glucose monitoring (CGM', 'HCM and LCM', 'High Versus Low Carbohydrate Intake', 'high-carbohydrate morning-intake (HCM) versus a low-carbohydrate-morning-intake (LCM']","['fasting blood glucose (FBG', 'mean amplitude of glucose excursions (MAGE', 'insulin sensitivity', 'blood glucose', 'Glycemic Variability and Glycemic Control', 'glycemic variability', 'glycemic variability and glucose control', 'mean glucose (MG', 'coefficient of variation (CV', 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR', 'blood glucose response']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",12.0,0.0165044,"In addition, insulin resistance, expressed as Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), decreased significantly during HCM.","[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Copenhagen, Denmark.'}, {'ForeName': 'Maria Lund', 'Initials': 'ML', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Wolff', 'Initials': 'CW', 'LastName': 'Poulsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rud', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Alexander Sidelmann', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 2-4, 2820 Gentofte, Denmark.'}, {'ForeName': 'Jens Rikardt', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Rolighedsvej 26, 1958 Frederiksberg C, Copenhagen, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Kampmann', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Hedeager 3, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Per Glud', 'Initials': 'PG', 'LastName': 'Ovesen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}]",Nutrients,['10.3390/nu12020475']
356,32075185,Preliminary Results of an Exercise Program After Laparoscopic Resective Colorectal Cancer Surgery in Non-Metastatic Adenocarcinoma: A Pilot Study of a Randomized Control Trial.,"Performing physical exercise after a colorectal cancer diagnosis is associated with lower mortality related to the tumor itself. In order to improve physical recovery after elective surgery, there are no specific exercise protocols after discharge from the hospital. The purpose of this study is to show the preliminary results of an exercise program after colorectal cancer surgery. Six patients with non-metastatic colorectal adenocarcinoma addressed to respective laparoscopic were randomly assigned to a mixed supervised/home-based exercise program for six months and compared to a control group without exercise. To assess the effectiveness of the program, functional and body composition parameters were evaluated. Three months after surgery, the exercise group increased flexibility (p < 0.01, ES = 0.33), strength of lower limbs (p < 0.01, ES = 0.42) and aerobic capacity (p < 0.01, ES = 0.28). After surgery, the six patients experienced a significant reduction in body mass index (BMI) and free fat mass. More specifically, fat mass reached the lowest values, with a concomitant increase in cell mass after six months (p < 0.01, ES = 0.33). This did not occur in the control group. Colorectal cancer treatment induces a reduction in physical function, particularly during the first six months after treatment. A mixed exercise approach appears promising in countering this process after colorectal cancer surgery.",2020,"Three months after surgery, the exercise group increased flexibility (p < 0.01, ES = 0.33), strength of lower limbs (p < 0.01, ES = 0.42) and aerobic capacity (p < 0.01, ES = 0.28).","['after colorectal cancer surgery', 'After Laparoscopic Resective Colorectal Cancer Surgery in Non', 'Metastatic Adenocarcinoma', 'Six patients with non-metastatic colorectal adenocarcinoma addressed to respective laparoscopic', 'colorectal cancer surgery']","['exercise program', 'Exercise Program', 'mixed exercise approach', 'mixed supervised/home-based exercise program for six months and compared to a control group without exercise', 'physical exercise']","['physical recovery', 'cell mass', 'strength of lower limbs', 'flexibility', 'physical function', 'aerobic capacity', 'body mass index (BMI) and free fat mass']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1319315', 'cui_str': 'Adenocarcinoma of large intestine'}, {'cui': 'C0376649', 'cui_str': 'Address'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",6.0,0.0213727,"Three months after surgery, the exercise group increased flexibility (p < 0.01, ES = 0.33), strength of lower limbs (p < 0.01, ES = 0.42) and aerobic capacity (p < 0.01, ES = 0.28).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Mascherini', 'Affiliation': 'Sport and Exercise Medicine Unit, Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50134 Firenze, Italy.'}, {'ForeName': 'Maria Novella', 'Initials': 'MN', 'LastName': 'Ringressi', 'Affiliation': 'MultidisciplinaryOncology Group, Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50134 Firenze, Italy.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Castizo-Olier', 'Affiliation': 'TecnoCampus Mataró-Maresme, EscuelaSuperior de Ciencias de la Salud, 08302 Mataró, Barcelona, Spain.'}, {'ForeName': 'Georgian', 'Initials': 'G', 'LastName': 'Badicu', 'Affiliation': 'Department of Physical Education and Special Motricity, Faculty of Physical Education and Mountain Sports, Transilvania University of Brasov, 500068 Brasov, Romania.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Irurtia', 'Affiliation': ""Departament de la Presidència, InstitutNacional d'EducacióFísica de Catalunya (INEFC), 08038 Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': 'Sport and Exercise Medicine Unit, Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50134 Firenze, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Galanti', 'Affiliation': 'Sport and Exercise Medicine Unit, Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50134 Firenze, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Taddei', 'Affiliation': 'MultidisciplinaryOncology Group, Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, 50134 Firenze, Italy.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56020078']
357,32000825,Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) - Study protocol from a randomized controlled trial.,"BACKGROUND


Observational studies indicate that beta-blockers are associated with a reduced risk of exacerbation and mortality in patients with chronic obstructive pulmonary disease (COPD) even without overt cardiovascular disease, but data from randomized controlled trials (RCT) are lacking. The aim of this RCT is to investigate whether beta-blocker therapy in patients with COPD without diagnosed cardiovascular disease is associated with a decreased 1-year risk of the composite endpoint of death, exacerbations, or cardiovascular events.
METHODS


The Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) study is an open-label, multicentre, prospective RCT. A total of 1700 patients with COPD will be randomly assigned to either standard COPD care and metoprolol at a target dose of 100 mg per day or to standard COPD care only. The primary endpoint is a composite of death, COPD exacerbations, and cardiovascular events. Major exclusion criteria are ischemic heart disease, left-sided heart failure, cerebrovascular disease, critical limb ischemia, and atrial fibrillation/flutter. Study visits are an inclusion visit, a metoprolol titration visit at 1 month, follow-up by telephone at 6 months, and a final study visit after 1 year. Outcome data are obtained from medical history and record review during study visits, as well as from national registries.
DISCUSSION


BRONCHIOLE is a pragmatic randomized trial addressing the potential of beta-blockers in patients with COPD. The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03566667. Registered on 25 June 2018.",2020,"The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD.
","['patieNts with CHronIc Obstructive puLmonary diseasE', '1700 patients with COPD', 'patients with COPD', 'patieNts with CHronIc Obstructive puLmonary diseasE ', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD without diagnosed cardiovascular disease']","['standard COPD care and metoprolol', 'Beta-blockeRs']","['composite of death, COPD exacerbations, and cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1700.0,0.261776,"The trial is expected to provide relevant clinical data on the efficacy of this treatment on patient-related outcomes in patients with COPD.
","[{'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Sundh', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. josefin.sundh@regionorebrolan.se.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Montgomery', 'Affiliation': 'Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Andell', 'Affiliation': 'Unit of Cardiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gustaf', 'Initials': 'G', 'LastName': 'Rindler', 'Affiliation': 'Lekeberg Primary Health Care Centre, Örebro, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3907-1']
358,31979019,Effects of Extrinsic Wheat Fiber Supplementation on Fecal Weight; A Randomized Controlled Trial.,"Higher fiber intake may confer beneficial effects on health. Our objective was to investigate the impact of 10 g extrinsic wheat fiber on fecal bulk. Therefore, we performed two randomized intervention studies in which we provided extrinsic wheat fiber-enriched products or appropriate control products for five days together with normal diet. In one trial, 10 participants received fiber-enriched food products, whereas in the second study, 19 participants supplemented their daily diet with fiber-enriched drinks. The main outcome variable of this intervention was fecal bulk. Other outcomes were gut microbiota composition, short chain fatty acids in feces, and stool consistency and frequency. Fecal wet weight was significantly increased (p < 0.02) with extrinsic wheat fiber-enriched foods. In contrast, ingestion of extrinsic wheat fiber in the form of drinks did not significantly change fecal wet weight. In both groups, fecal dry weight was not altered upon extrinsic wheat fiber supplementation. However, the intake of fiber-enriched foods resulted in higher acetic acid levels in feces compared to fiber-enriched drinks. Regarding gut microbiota profiles, extrinsic wheat fiber-enriched food products were not associated with substantial alterations. In conclusion, 10 g extrinsic wheat fiber added to a normal diet increased fecal bulk if administered in a solid food matrix, but not if applied in the form of drinks. DRKS, DRKS00015792.Registered 30 October 2018.",2020,Fecal wet weight was significantly increased (p < 0.02) with extrinsic wheat fiber-enriched foods.,['10 participants received'],"['Extrinsic Wheat Fiber Supplementation', 'fiber-enriched food products', 'daily diet with fiber-enriched drinks']","['Fecal Weight', 'fecal bulk', 'acetic acid levels', 'Fecal wet weight', 'fecal dry weight', 'gut microbiota composition, short chain fatty acids in feces, and stool consistency and frequency']",[],"[{'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0016498', 'cui_str': 'Enriched Food'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205381', 'cui_str': 'Wet (qualifier value)'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",19.0,0.0830102,Fecal wet weight was significantly increased (p < 0.02) with extrinsic wheat fiber-enriched foods.,"[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Brandl', 'Affiliation': 'ZIEL - Institute for Food & Health, Technical University of Munich, Gregor-Mendel-Str. 2, 85354 Freising, Germany.'}, {'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Else Kröner-Fresenius-Center of Nutritional Medicine, Technical University of Munich, Gregor-Mendel-Str. 2, 85354 Freising, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Dunkel', 'Affiliation': 'Leibniz-Institute for Food Systems Biology at the Technical University of Munich, Lise-Meitner-Straße 34, 85354 Freising, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hofmann', 'Affiliation': 'Leibniz-Institute for Food Systems Biology at the Technical University of Munich, Lise-Meitner-Straße 34, 85354 Freising, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Hauner', 'Affiliation': 'ZIEL - Institute for Food & Health, Technical University of Munich, Gregor-Mendel-Str. 2, 85354 Freising, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Skurk', 'Affiliation': 'ZIEL - Institute for Food & Health, Technical University of Munich, Gregor-Mendel-Str. 2, 85354 Freising, Germany.'}]",Nutrients,['10.3390/nu12020298']
359,32023901,Effects of 12-Week Ingestion of Yogurt Containing  Lactobacillus plantarum  OLL2712 on Glucose Metabolism and Chronic Inflammation in Prediabetic Adults: A Randomized Placebo-Controlled Trial.,"The ingestion of  Lactobacillus plantarum  OLL2712 (OLL2712) cells improved glucose metabolism by suppressing chronic inflammation in mouse models and in a preliminary clinical study. We aimed to clarify the effect of OLL2712 on glucose metabolism and chronic inflammation for healthy adults. Prediabetic adults ( n  = 130, age range: 20-64 years) were randomly assigned to either the placebo or OLL2712 groups ( n  = 65 each) and were administered conventional yogurt or yogurt containing more than 5 × 10 9  heat-treated OLL2712 cells, respectively, daily for 12 weeks. Reduced HbA1c levels after 12 weeks of treatment were observed in both groups compared to those at baseline; however, the 12-week reduction of HbA1c levels was significantly greater in the OLL2712 group than in the placebo group. Increased chronic inflammation marker levels and insulin-resistant index (HOMA-IR) occurred in the placebo group but not in the OLL2712 group. Fasting blood glucose (FBG) levels did not change significantly in both groups; however, in subgroup analyses including participants with higher FBG levels, FBG levels were significantly reduced only in the OLL2712 group compared to baseline. These results suggest that OLL2712 cell ingestion can reduce HbA1c levels and can prevent the aggravation of chronic inflammation and insulin resistance.",2020,Increased chronic inflammation marker levels and insulin-resistant index (HOMA-IR) occurred in the placebo group but not in the OLL2712 group.,"['Prediabetic Adults', 'healthy adults', 'Prediabetic adults ( n  = 130, age range: 20-64 years']","['Placebo', 'conventional yogurt or yogurt containing more than 5 × 10 9  heat-treated OLL2712 cells', 'OLL2712 cell ingestion', 'placebo', 'placebo or OLL2712', 'OLL2712 (OLL2712) cells', 'Yogurt Containing  Lactobacillus plantarum  OLL2712', 'OLL2712']","['aggravation of chronic inflammation and insulin resistance', 'Fasting blood glucose (FBG) levels', 'Increased chronic inflammation marker levels and insulin-resistant index (HOMA-IR', 'Glucose Metabolism and Chronic Inflammation', 'FBG levels, FBG levels', 'HbA1c levels', 'glucose metabolism and chronic inflammation', 'Reduced HbA1c levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}]","[{'cui': 'C0021376', 'cui_str': 'Chronic inflammatory reaction'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.105806,Increased chronic inflammation marker levels and insulin-resistant index (HOMA-IR) occurred in the placebo group but not in the OLL2712 group.,"[{'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Toshimitsu', 'Affiliation': 'Applied Microbiology Research Department, Food Microbiology Research Laboratories, Division of Research and Development, Meiji Co., Ltd., Hachiouji, Tokyo 192-0919, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Gotou', 'Affiliation': 'Applied Microbiology Research Department, Food Microbiology Research Laboratories, Division of Research and Development, Meiji Co., Ltd., Hachiouji, Tokyo 192-0919, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Sashihara', 'Affiliation': 'Applied Microbiology Research Department, Food Microbiology Research Laboratories, Division of Research and Development, Meiji Co., Ltd., Hachiouji, Tokyo 192-0919, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hachimura', 'Affiliation': 'Research Center for Food Safety, Graduate School of Agricultural and Life Sciences, The University of Tokyo, Bunkyo-ku, Tokyo 113-8657, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Shioya', 'Affiliation': 'Statistical Analysis Department, KSO Corporation, Minato-ku, Tokyo 105-0023, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Shinagawa Season Terrace Health Care Clinic, Minato-ku, Tokyo 108-0075, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Asami', 'Affiliation': 'Applied Microbiology Research Department, Food Microbiology Research Laboratories, Division of Research and Development, Meiji Co., Ltd., Hachiouji, Tokyo 192-0919, Japan.'}]",Nutrients,['10.3390/nu12020374']
360,32023922,"A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Effects of  Angelica Gigas  Nakai Extract on Blood Triglycerides.","Angelica gigas  Nakai, Korean dang-gui, has long been widely used in traditional treatment methods. There have been a number of studies of the health effects of  A. gigas  and related compounds, but studies addressing effects on blood triglycerides (TG) are lacking. To investigate the effects of  A. gigas  Nakai extract (AGNE) on TG in Korean subjects, we carried out a 12-week, randomized, double-blind, placebo-controlled clinical trial. Subjects who met the inclusion criterion (130 mg/dL ≤ fasting blood TG ≤ 200 mg/dL) were recruited for this study. One hundred subjects were assigned to the AGNE group ( n  = 50) or the placebo group ( n  = 50), who were given 1 g/day of AGNE (as  a gigas  Nakai extract 200 mg/d) in capsules and the control group for 12 weeks. Outcomes were efficacy TG, lipid profiles, atherogenic index, and safety parameters were assessed initially for a baseline measurement and after 12 weeks. After 12 weeks of supplementation, TG and very low-density lipoprotein cholesterol (VLDL-C) concentration and TG/HDL-C ratio in the AGNE group were significantly reduced compared to the placebo group ( p  < 05). No significant changes in any safety parameter were observed. These results suggest that the ingestion of AGNE may improve TG and be useful to manage or prevent hypertriglyceridemia.",2020,No significant changes in any safety parameter were observed.,"['Korean subjects', 'Subjects who met the inclusion criterion (130 mg/dL ≤ fasting blood TG ≤ 200 mg/dL', 'One hundred subjects']","['Placebo', 'AGNE', 'Angelica Gigas  Nakai Extract', 'placebo', 'A. gigas  Nakai extract (AGNE']","['blood triglycerides (TG', 'safety parameter', 'Blood Triglycerides', 'efficacy TG, lipid profiles, atherogenic index, and safety parameters', 'TG and very low-density lipoprotein cholesterol (VLDL-C) concentration and TG/HDL-C ratio']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005768'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0936217', 'cui_str': 'Angelica'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",100.0,0.309991,No significant changes in any safety parameter were observed.,"[{'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}, {'ForeName': 'Woo-Rim', 'Initials': 'WR', 'LastName': 'Kim', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}, {'ForeName': 'Mi-Ra', 'Initials': 'MR', 'LastName': 'Oh', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}, {'ForeName': 'Youn-Soo', 'Initials': 'YS', 'LastName': 'Cha', 'Affiliation': 'Department of Food Science and Human Nutrition, Chonbuk National University, Jeonju, Jeonbuk 54896, Korea.'}, {'ForeName': 'Byung-Hyun', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Chonbuk National University Medical School Jeonju, Jeonbuk 54896, Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, Jeonju, Jeonbuk 54907, Korea.'}]",Nutrients,['10.3390/nu12020377']
361,32131849,Five-year cost-effectiveness analysis of the European Fans in Training (EuroFIT) physical activity intervention for men versus no intervention.,"OBJECTIVES


Increasing physical activity reduces the risk of chronic illness including Type 2 diabetes, cardiovascular disease and certain types of cancer. Lifestyle interventions can increase physical activity but few successfully engage men. This study aims to investigate the 5 year cost-effectiveness of EuroFIT, a program to improve physical activity tailored specifically for male football (soccer) fans compared to a no intervention comparison group.
METHODS


We developed a Markov cohort model in which the impact of improving physical activity on five chronic health conditions (colorectal cancer, Type 2 diabetes, coronary heart disease, stroke and depression) and mortality was modelled. We estimated costs from a societal perspective and expressed benefits as quality adjusted life years (QALYs). We obtained data from a 4-country (England, Netherlands, Portugal and Norway) pragmatic randomised controlled trial evaluating EuroFIT, epidemiological and cohort studies, and meta-analyses. We performed deterministic and probabilistic sensitivity analyses to assess the impact of uncertainty in the model's parameter values on the cost-effectiveness results. We used Monte Carlo simulations to estimate uncertainty and presented this using cost-effectiveness acceptability curves (CEACs). We tested the robustness of the base case analysis using five scenario analyses.
RESULTS


Average costs over 5 years per person receiving EuroFIT were €14,663 and per person receiving no intervention €14,598. Mean QALYs over 5 years were 4.05 per person for EuroFIT and 4.04 for no intervention. Thus, the average incremental cost per person receiving EuroFIT was €65 compared to no intervention, while the average QALY gain was 0.01. This resulted in an ICER of €5206 per QALY gained. CEACs show that the probability of EuroFIT being cost-effective compared to no intervention is 0.53, 0.56 and 0.58 at thresholds of €10,000, €22,000 and €34,000 per QALY gained, respectively. When using a time horizon of 10 years, the results suggest that EuroFIT is more effective and less expensive compared to (i.e. dominant over) no intervention with a probability of cost-effectiveness of 0.63 at a threshold of €22,000 per QALY gained.
CONCLUSIONS


We conclude the EuroFIT intervention is not cost-effective compared to no intervention over a period of 5 years from a societal perspective, but is more effective and less expensive (i.e. dominant) after 10 years. We thus suggest that EuroFIT can potentially improve public health in a cost-effective manner in the long term.",2020,"CEACs show that the probability of EuroFIT being cost-effective compared to no intervention is 0.53, 0.56 and 0.58 at thresholds of €10,000, €22,000 and €34,000 per QALY gained, respectively.",['male football (soccer'],"['Lifestyle interventions', 'EuroFIT', 'European Fans in Training (EuroFIT) physical activity intervention', 'EuroFIT intervention']","['physical activity', 'public health', 'average QALY gain', 'Mean QALYs', 'probability of EuroFIT being cost-effective', 'cost-effectiveness acceptability curves (CEACs']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.046332,"CEACs show that the probability of EuroFIT being cost-effective compared to no intervention is 0.53, 0.56 and 0.58 at thresholds of €10,000, €22,000 and €34,000 per QALY gained, respectively.","[{'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Kolovos', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Amsterdam UMC, VU medical center, Department of Public and Occupational Health, Amsterdam Public Health research institute, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Nassau', 'Affiliation': 'Amsterdam UMC, VU medical center, Department of Public and Occupational Health, Amsterdam Public Health research institute, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Hana M', 'Initials': 'HM', 'LastName': 'Broulikova', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Agni', 'Initials': 'A', 'LastName': 'Baka', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Amsterdam UMC, VU medical center, Department of Public and Occupational Health, Amsterdam Public Health research institute, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bunn', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Glyn C', 'Initials': 'GC', 'LastName': 'Roberts', 'Affiliation': 'Department of coaching and psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'Marlene N', 'Initials': 'MN', 'LastName': 'Silva', 'Affiliation': 'CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Jason M R', 'Initials': 'JMR', 'LastName': 'Gill', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Røynesdal', 'Affiliation': 'Department of coaching and psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Mechelen', 'Affiliation': 'Amsterdam UMC, VU medical center, Department of Public and Occupational Health, Amsterdam Public Health research institute, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Department of coaching and psychology, Norwegian School of Sport Science, Oslo, Norway.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Institute for Social Marketing and Health, University of Stirling, Stirling, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, College of Social Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam, The Netherlands. j.e.bosmans@vu.nl.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00934-7']
362,31962344,Activation of D1 receptors affects human reactivity and flexibility to valued cues.,"Reward-predicting cues motivate goal-directed behavior, but in unstable environments humans must also be able to flexibly update cue-reward associations. While the capacity of reward cues to trigger motivation ('reactivity') as well as flexibility in cue-reward associations have been linked to the neurotransmitter dopamine in humans, the specific contribution of the dopamine D1 receptor family to these behaviors remained elusive. To fill this gap, we conducted a randomized, placebo-controlled, double-blind pharmacological study testing the impact of three different doses of a novel D1 agonist (relative to placebo) on reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning). We observed that the impact of the D1 agonist crucially depended on baseline working memory functioning, which has been identified as a proxy for baseline dopamine synthesis capacity. Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity. In contrast, higher doses of the D1 agonist improved reversal learning only in individuals with low baseline working memory functioning. Our findings suggest a crucial and baseline-dependent role of D1 receptor activation in controlling both cue reactivity and the flexibility of cue-reward associations.",2020,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.",[],"['novel D1 agonist (relative to placebo', 'placebo']","['reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning', 'reversal learning']",[],"[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.119234,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany. Alexander.Soutschek@psy.lmu.de.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'de Martinis', 'Affiliation': 'Praxis Precision Medicines, Cambridge, MA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Howe', 'Affiliation': 'School of Neuroscience, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Burke', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jetter', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0617-z']
363,32005294,"Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India.","BACKGROUND


The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. Further, the effect of delivery of an intervention package in the pre and peri-conception period is not fully understood. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children.
METHODS


An individually randomized controlled trial with factorial design is being conducted in urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India. 13,500 married women aged 18 to 30 years will be enrolled and randomized to receive either the pre and peri-conception intervention package or routine care (first randomization). Interventions will be delivered until women are confirmed to be pregnant or complete 18 months of follow up. Once pregnancy is confirmed, women are randomized again (second randomization) to receive either the intervention package for pregnancy and postnatal period or to routine care. Newborns will be followed up till 24 months of age. The interventions are delivered through different study teams. Outcome data are collected by an independent outcome ascertainment team.
DISCUSSION


This study will demonstrate the improvement that can be achieved when key factors known to limit child growth and development are addressed together, throughout the continuum from pre and peri-conception until early childhood. The findings will increase our scientific understanding and provide guidance to nutrition programs in low- and middle-income settings.
TRIAL REGISTRATION


Clinical Trial Registry - India #CTRI/2017/06/008908; Registered 23 June 2017, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies.",2020,"Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth.","['children', 'urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India', '13,500 married women aged 18 to 30\u2009years', 'young children']","['integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood', 'pre and peri-conception intervention package or routine care (first randomization']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",[],13500.0,0.107769,"Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth.","[{'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.'}, {'ForeName': 'Ranadip', 'Initials': 'R', 'LastName': 'Chowdhury', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Dhabhai', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Mazumder', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.'}, {'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.'}, {'ForeName': 'Sitanshi', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India.'}, {'ForeName': 'Rupali', 'Initials': 'R', 'LastName': 'Dewan', 'Affiliation': 'Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': 'Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Chellani', 'Affiliation': 'Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Maharaj Kishan', 'Initials': 'MK', 'LastName': 'Bhan', 'Affiliation': 'Knowledge Integration and Translational Platform (KnIT), Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Government of India, New Delhi, India.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi, India. nita.bhandari@sas.org.in.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4059-z']
364,31995811,Nicotine dependence (trait) and acute nicotinic stimulation (state) modulate attention but not inhibitory control: converging fMRI evidence from Go-Nogo and Flanker tasks.,"Cognitive deficits during nicotine withdrawal may contribute to smoking relapse. However, interacting effects of chronic nicotine dependence and acute nicotine withdrawal on cognitive control are poorly understood. Here we examine the effects of nicotine dependence (trait; smokers (n = 24) vs. non-smoking controls; n = 20) and acute nicotinic stimulation (state; administration of nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning. We compared performance and neural responses between these four pharmacological manipulations in a double-blind, placebo-controlled crossover design. As expected, performance in both tasks was modulated by nicotine dependence, abstinence, and pharmacological manipulation. However, effects were driven entirely by conditions that required less inhibitory control. When demand for inhibitory control was high, abstinent smokers showed no deficits. By contrast, acutely abstinent smokers showed performance deficits in easier conditions and missed more trials. Go-Nogo fMRI results showed decreased inhibition-related neural activity in right anterior insula and right putamen in smokers and decreased dorsal anterior cingulate cortex activity on nicotine across groups. No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task. Given robust nicotinic effects on physiology and behavioral deficits in attention, we are confident that pharmacological manipulations were effective. Thus findings fit a recent proposal that abstinent smokers show decreased ability to divert cognitive resources at low or intermediate cognitive demand, while performance at high cognitive demand remains relatively unaffected, suggesting a primary attentional deficit during acute abstinence.",2020,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,['trait; smokers (n\u2009=\u200924) vs. non-smoking controls; n\u2009=\u200920) and acute nicotinic stimulation (state; administration of'],"['nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning', 'nicotine dependence', 'placebo', 'Nicotine dependence (trait) and acute nicotinic stimulation (state']","['dorsal anterior cingulate cortex activity', 'inhibition-related neural activity', 'performance deficits', 'Cognitive deficits', 'inhibition-related activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0240423,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lesage', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Sutherland', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Salmeron', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Estein@nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0623-1']
365,32013045,Saliva Samples as A Tool to Study the Effect of Meal Timing on Metabolic And Inflammatory Biomarkers.,":  Meal timing affects metabolic regulation in humans. Most studies use blood samples for their investigations. Saliva, although easily available and non-invasive, seems to be rarely used for chrononutritional studies. In this pilot study, we tested if saliva samples could be used to study the effect of timing of carbohydrate and fat intake on metabolic rhythms. In this cross-over trial, 29 nonobese men were randomized to two isocaloric 4-week diets: (1) carbohydrate-rich meals until 13:30 and high-fat meals between 16:30 and 22:00 or (2) the inverse order of meals. Stimulated saliva samples were collected every 4 h for 24 h at the end of each intervention, and levels of hormones and inflammatory biomarkers were assessed in saliva and blood. Cortisol, melatonin, resistin, adiponectin, interleukin-6 and MCP-1 demonstrated distinct diurnal variations, mirroring daytime reports in blood and showing significant correlations with blood levels. The rhythm patterns were similar for both diets, indicating that timing of carbohydrate and fat intake has a minimal effect on metabolic and inflammatory biomarkers in saliva. Our study revealed that saliva is a promising tool for the non-invasive assessment of metabolic rhythms in chrononutritional studies, but standardisation of sample collection is needed in out-of-lab studies.",2020,"Cortisol, melatonin, resistin, adiponectin, interleukin-6 and MCP-1 demonstrated distinct diurnal variations, mirroring daytime reports in blood and showing significant correlations with blood levels.","['29 nonobese men', 'humans']",['isocaloric 4-week diets: (1) carbohydrate-rich meals'],"['levels of hormones and inflammatory biomarkers', 'Stimulated saliva samples', 'Cortisol, melatonin, resistin, adiponectin, interleukin-6 and MCP-1 demonstrated distinct diurnal variations, mirroring daytime reports in blood']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0005768'}]",29.0,0.0402926,"Cortisol, melatonin, resistin, adiponectin, interleukin-6 and MCP-1 demonstrated distinct diurnal variations, mirroring daytime reports in blood and showing significant correlations with blood levels.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kessler', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, 14558 Nuthetal, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hornemann', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, 14558 Nuthetal, Germany.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Rudovich', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, 14558 Nuthetal, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Department of Molecular Toxicology, German Institute of Human Nutrition Potsdam-Rehbruecke (DIfE), 14558 Nuthetal, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Grune', 'Affiliation': 'German Center for Diabetes Research (DZD), 85764 München-Neuherberg, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Laboratory of Chronobiology, Institute for Medical Immunology, Charité University of Medicine, 10117 Berlin, Germany.'}, {'ForeName': 'Andreas F H', 'Initials': 'AFH', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, 14558 Nuthetal, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pivovarova-Ramich', 'Affiliation': 'Department of Clinical Nutrition, German Institute of Human Nutrition Potsdam-Rehbruecke, 14558 Nuthetal, Germany.'}]",Nutrients,['10.3390/nu12020340']
366,31785588,Increased subjective and reinforcing effects of initial nicotine exposure in young adults with attention deficit hyperactivity disorder (ADHD) compared to matched peers: results from an experimental model of first-time tobacco use.,"Individuals with attention deficit hyperactivity disorder (ADHD) are at increased risk for adverse cigarette smoking outcomes, and little is known about factors underlying this risk. This study sought to evaluate the effects of initial nicotine exposure in young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences. Participants were young adult nonsmokers (n = 61 ADHD, n = 75 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years. Participants were exposed to three different blinded doses of intranasally administered nicotine (0, 0.5, 1.0 mg) across three separate fixed dose experimental sessions. In subsequent sessions, participants were given the opportunity to self-administer nicotine under two different conditions-high and low cognitive demand. Physiological, subjective, and reinforcing effects of nicotine were the main outcomes. Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups. ADHD participants reported significantly greater dizziness following nicotine, and greater pleasant subjective effects across all conditions, compared to non-ADHD non-smokers. There were no group differences on subjective reports of bad or unpleasant effects. Subsequent nicotine self-administration was significantly higher among non-smokers with ADHD, and their choices of nicotine were not influenced by cognitive condition. There are meaningful differences between young adults with and without ADHD with respect to the initial subjective and reinforcing effects of nicotine; and interventions to prevent use should start prior to typical age of experimentation among ADHD patients.",2020,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","['young adults with attention deficit hyperactivity disorder (ADHD', 'Participants were young adult nonsmokers (n\u2009=\u200961 ADHD, n\u2009=\u200975 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years', 'Individuals with attention deficit hyperactivity disorder (ADHD', 'young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences']","['initial nicotine exposure', 'nicotine']","['Nicotine plasma levels', 'subjective reports of bad or unpleasant effects', 'pleasant subjective effects', 'dizziness', 'heart rate or blood pressure']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",61.0,0.016876,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. scott.kollins@duke.edu.'}, {'ForeName': 'Maggie M', 'Initials': 'MM', 'LastName': 'Sweitzer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Departments of Psychiatry, Psychology, and Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0581-7']
367,32023931,Comparable Postprandial Amino Acid and Gastrointestinal Hormone Responses to Beef Steak Cooked Using Different Methods: A Randomised Crossover Trial.,"Cooking changes the texture and tenderness of red meat, which may influence its digestibility, circulatory amino acids (AA) and gastrointestinal (GI) hormonal responses in consumers.  In a randomised crossover intervention, healthy males ( n  = 12) consumed a beef steak sandwich, in which the beef was cooked by either a pan-fried (PF) or sous-vide (SV) method. Plasma AA were measured by ultrahigh performance liquid chromatography (UPLC), while plasma GI hormones were measured using a flow cytometric multiplex array. Following meat ingestion, the circulatory concentrations of some of the essential AA (all the branched-chain AA: leucine, isoleucine and valine; and threonine), some of the nonessential AA (glycine, alanine, tyrosine and proline) and some of the nonproteogenic AA (taurine, citrulline and ornithine) were increased from fasting levels by 120 or 180 min ( p  < 0.05). There were no differences in circulating AA concentrations between cooking methods. Likewise, of the measured GI hormones, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) concentrations increased from fasting levels after consumption of the steak sandwich ( p  < 0.05), with no differences between the cooking methods. In the healthy male adults, protein digestion and circulating GI hormone responses to a beef-steak breakfast were unaltered by the different cooking methods.",2020,"(GLP-1) concentrations increased from fasting levels after consumption of the steak sandwich ( p  < 0.05), with no differences between the cooking methods.","['healthy male adults', 'healthy males ( n  = 12']","['consumed a beef steak sandwich, in which the beef was cooked by either a pan-fried (PF) or sous-vide (SV) method']","['Plasma AA', 'protein digestion and circulating GI hormone responses', 'digestibility, circulatory amino acids (AA) and gastrointestinal (GI) hormonal responses', 'circulating AA concentrations', 'measured GI hormones, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1', 'ultrahigh performance liquid chromatography (UPLC), while plasma GI hormones']","[{'cui': 'C0686751', 'cui_str': 'Well male adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0452850', 'cui_str': 'Beef steak (substance)'}, {'cui': 'C4543503', 'cui_str': 'Sandwich (substance)'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1523943'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}]",,0.109832,"(GLP-1) concentrations increased from fasting levels after consumption of the steak sandwich ( p  < 0.05), with no differences between the cooking methods.","[{'ForeName': 'Utpal K', 'Initials': 'UK', 'LastName': 'Prodhan', 'Affiliation': 'Liggins Institute, The University of Auckland, 85 Park Road, Grafton, Private Bag 92019, Auckland 1023, New Zealand.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Pundir', 'Affiliation': 'Liggins Institute, The University of Auckland, 85 Park Road, Grafton, Private Bag 92019, Auckland 1023, New Zealand.'}, {'ForeName': 'Vic S-C', 'Initials': 'VS', 'LastName': 'Chiang', 'Affiliation': 'Liggins Institute, The University of Auckland, 85 Park Road, Grafton, Private Bag 92019, Auckland 1023, New Zealand.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'Liggins Institute, The University of Auckland, 85 Park Road, Grafton, Private Bag 92019, Auckland 1023, New Zealand.'}, {'ForeName': 'Matthew P G', 'Initials': 'MPG', 'LastName': 'Barnett', 'Affiliation': 'Riddet Institute, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Greg C', 'Initials': 'GC', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of New South Wales, NSW 2052, Australia.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Markworth', 'Affiliation': 'Department of Molecular and Integrative Physiology, University of Michigan, MI 48109, USA.'}, {'ForeName': 'Scott O', 'Initials': 'SO', 'LastName': 'Knowles', 'Affiliation': 'Food & Bio-Based Products Group, AgResearch Limited, Private Bag 11008, Palmerston North 4442, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute, The University of Auckland, 85 Park Road, Grafton, Private Bag 92019, Auckland 1023, New Zealand.'}]",Nutrients,['10.3390/nu12020380']
368,31463874,Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection.,"PURPOSE


The DNA fragmentation in sperm is associated with reduced outcome in assisted reproduction. Using YoPro1 as the staining dye and flow cytometry and sorting (FACS), the number of spermatozoa with DNA fragmentation can be lowered to 5%. Can the cumulative outcome of ICSI be improved using FACS?
METHODS


A prospective, randomized, double-blind clinical trial was conducted in 104 infertile couples with male infertility based on abnormal conventional semen analysis results. Cumulative ongoing pregnancy rate was the primary outcome parameter. In 52 cases, semen was processed for ICSI using swim-up. In another 52 cases, spermatozoa with fragmented DNA were removed with FACS.
RESULTS


The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up. An interim analysis scheduled before initiation of the study after 100 cases demonstrated that the aim of a 20% gain in pregnancy rate could not be achieved. For that reason, the prospective study was stopped prematurely.
CONCLUSIONS


A trend towards consistently better results was achieved by removing spermatozoa with fragmented DNA. The fragmentation of the DNA in sperm is the end stage of apoptosis. Sorting of spermatozoa may be improved by selecting parameters of processes active more upstream of apoptosis, such as chromatin decondensation.
TRIAL REGISTRATION


NCT02166567 . June 14, 2014.",2019,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,['104 infertile couples with male infertility based on abnormal conventional semen analysis results'],[],"['Cumulative ongoing pregnancy rate', 'pregnancy rate', 'cumulative pregnancy rate', 'live birth rate', 'miscarriage rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.368995,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'De Geyter', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland. christian.degeyter@usb.ch.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Gobrecht-Keller', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ahler', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-019-01571-1']
369,24794367,Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: a randomized clinical trial.,"IMPORTANCE


Invasive candidiasis in premature infants causes death and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality and the safety of fluconazole are unknown.
OBJECTIVE


To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants.
DESIGN, SETTING, AND PATIENTS


This study was a randomized, blinded, placebo-controlled trial of fluconazole in premature infants. Infants weighing less than 750 g at birth (N = 361) from 32 neonatal intensive care units (NICUs) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for 42 days. Surviving infants were evaluated at 18 to 22 months corrected age for neurodevelopmental outcomes. The study was conducted between November 2008 and February 2013.
INTERVENTIONS


Fluconazole (6 mg/kg of body weight) or placebo.
MAIN OUTCOMES AND MEASURES


The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day 49 (1 week after completion of study drug). Secondary and safety outcomes included invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy at 18 to 22 months corrected age.
RESULTS


Among infants receiving fluconazole, the composite primary end point of death or invasive candidiasis was 16% (95% CI, 11%-22%) vs 21% in the placebo group (95% CI, 15%-28%; odds ratio, 0.73 [95% CI, 0.43-1.23]; P = .24; treatment difference, -5% [95% CI, -13% to 3%]). Invasive candidiasis occurred less frequently in the fluconazole group (3% [95% CI, 1%-6%]) vs the placebo group (9% [95% CI, 5%-14%]; P = .02; treatment difference, -6% [95% CI, -11% to -1%]). The cumulative incidences of other secondary outcomes were not statistically different between groups. Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
CONCLUSIONS AND RELEVANCE


Among infants with a birth weight of less than 750 g, 42 days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis. These findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00734539.",2014,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
","['Infants weighing less than 750 g at birth (N\u2009=\u2009361) from 32 neonatal intensive care units (NICUs) in the United States', 'extremely low-birth-weight infants', 'infants with a birth weight of less than 750 g, 42 days of', 'premature infants', 'November 2008 and February 2013']","['placebo', 'fluconazole or placebo', 'fluconazole', 'prophylactic fluconazole', 'Fluconazole prophylaxis', 'fluconazole prophylaxis', 'Fluconazole']","['cumulative incidences', 'invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes-defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy', 'composite of death or definite or probable invasive candidiasis', 'Invasive candidiasis', 'efficacy and safety', 'candidiasis and mortality', 'Neurodevelopmental impairment', 'composite of death or invasive candidiasis', 'death or invasive candidiasis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0004623', 'cui_str': 'Bacterial Infections'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0023529', 'cui_str': 'Encephalomalacia, Periventricular'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.60973,"Neurodevelopmental impairment did not differ between the groups (fluconazole, 31% [95% CI, 21%-41%] vs placebo, 27% [95% CI, 18%-37%]; P = .60; treatment difference, 4% [95% CI, -10% to 17%]).
","[{'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine-Jacksonville.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Duara', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Randolph', 'Affiliation': 'University of Alabama-Birmingham.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Bidegain', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Burchfield', 'Affiliation': 'University of Florida Health Shands Hospital, Gainesville.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'White', 'Affiliation': 'Memorial Hospital South Bend, South Bend, Indiana.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Shattuck', 'Affiliation': 'University of Texas Medical Branch, Galveston.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Neu', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bendel', 'Affiliation': ""University of Minnesota Amplatz Children's Hospital, Minneapolis.""}, {'ForeName': 'M Roger', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': 'Brookdale University Hospital, Brooklyn, New York.'}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Finer', 'Affiliation': 'University of California-San Diego Medical Center.'}, {'ForeName': 'Dan L', 'Initials': 'DL', 'LastName': 'Stewart', 'Affiliation': 'University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, California.""}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""Sant'Anna Hospital, Turin, Italy.""}, {'ForeName': 'Kristi O', 'Initials': 'KO', 'LastName': 'Prather', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Testoni', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Katherine Y', 'Initials': 'KY', 'LastName': 'Berezny', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2014.2624']
370,32187781,"Respiratory safety of lemborexant in healthy adult and elderly subjects with mild obstructive sleep apnea: A randomized, double-blind, placebo-controlled, crossover study.","Lemborexant is a dual orexin receptor antagonist indicated for the treatment of adult and elderly individuals with insomnia. Some current pharmacologic treatments for insomnia cause respiratory depression, a serious safety concern, particularly for individuals with obstructive sleep apnea (OSA). This phase 1, randomized, double-blind, placebo-controlled, two-period crossover study examined respiratory safety parameters in individuals with mild OSA following treatment with lemborexant. Participants (n = 39) were randomized to one of two treatment sequences, including placebo and lemborexant 10 mg. Each treatment period lasted 8 days and was separated by a washout of at least 14 days. Following single or multiple doses, there were no significant differences in mean apnea-hypopnea index for lemborexant 10 mg versus placebo (least squares mean [LSM] difference [95% confidence interval {CI}]: day 1, -0.03 [-2.22, 2.17]; day 8, -0.06 [-1.95, 1.83]) or peripheral capillary oxygen saturation during sleep (LSM difference [95% CI]: day 1, 0.07 [-0.31, 0.46]; day 8, 0.25 [-0.11, 0.61]). There were no significant differences versus placebo for the percentage of total sleep time during which peripheral capillary oxygen saturation was <80% (LSM difference [95% CI]: day 1, 0.002 [-0.019, 0.023]; day 8, 0.006 [-0.015, 0.026]), <85% (LSM difference [95% CI]: day 1, 0.067 [-0.124, 0.258]; day 8, 0.056 [-0.117, 0.228]) or <90% (LSM difference [95% CI]: day 1, 0.312 [-0.558, 1.181]; day 8, 0.088 [-0.431, 0.607]). The incidence of treatment-emergent adverse events was low and similar for lemborexant and placebo. Lemborexant demonstrated respiratory safety in this study population and was well tolerated.",2020,"There were no significant differences versus placebo for the percentage of total sleep time during which peripheral capillary oxygen saturation was <80% (LSM difference [95% CI]: day 1, 0.002","['individuals with mild OSA following treatment with lemborexant', 'Participants (n\xa0=\xa039', 'healthy adult and elderly subjects with mild obstructive sleep apnea', 'individuals with obstructive sleep apnea (OSA', 'adult and elderly individuals with insomnia']","['Lemborexant', 'lemborexant', 'placebo and lemborexant 10\xa0mg', 'placebo']","['respiratory safety', 'tolerated', 'Respiratory safety', 'total sleep time during which peripheral capillary oxygen saturation', 'peripheral capillary oxygen saturation', 'incidence of treatment-emergent adverse events', 'mean apnea-hypopnea index']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C2711376', 'cui_str': 'ScO2 - Capillary oxygen saturation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]",39.0,0.451262,"There were no significant differences versus placebo for the percentage of total sleep time during which peripheral capillary oxygen saturation was <80% (LSM difference [95% CI]: day 1, 0.002","[{'ForeName': 'Jocelyn Y', 'Initials': 'JY', 'LastName': 'Cheng', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Drug Corporation, New York, New York, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bsharat', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}]",Journal of sleep research,['10.1111/jsr.13021']
371,31711065,Repetitive transcranial magnetic stimulation targeting the insular cortex for reduction of heavy drinking in treatment-seeking alcohol-dependent subjects: a randomized controlled trial.,"Insula responses to drug cues are correlated with cravings, and lesions in this area reduce nicotine seeking. Here, we investigated the potential efficacy of repetitive transcranial magnetic stimulation (rTMS) targeting the insula in alcohol addiction. Treatment-seeking alcohol-dependent patients (Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition; N = 56) participated in this double-blind, sham-controlled, randomized trial. Participants received 10 Hz rTMS or sham using an H8 coil, 5 days a week for 3 weeks. Stimulation targeted insular cortex and overlaying regions bilaterally, while excluding anterior prefrontal areas. Craving and self-reported as well as biomarker-based drinking measures were collected at baseline, during treatment, and through 12 weeks. Resting-state magnetic resonance imaging (rsMRI) data were collected before and after treatment. Task-based MRI was used to probe brain correlates of reward processing, affective responses, and alcohol following completion of treatment. A marked overall decrease in craving and drinking measures was observed during treatment, but did not differ between rTMS or sham stimulation. Both groups equally increased their alcohol use following completion of treatment and through the 12-week follow-up. Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function. However, while each task robustly replicated brain responses established in the literature, no effects of rTMS were found. Collectively, this study does not support efficacy of rTMS targeting the insula in alcohol addiction.",2020,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.",['treatment-seeking alcohol-dependent subjects'],"['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\u2009Hz rTMS']","['heavy drinking', 'craving and drinking measures']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0893144,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Perini', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden. irene.perini@liu.se.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kämpe', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Arlestig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Löfberg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pietrzak', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0565-7']
372,31865282,"""Randomised controlled trial of scalp cooling for the prevention of chemotherapy induced alopecia"".","BACKGROUND


Randomized controlled trials (RCT) of scalp cooling (SC) to prevent chemotherapy induced alopecia (CIA) did not evaluate its effect on hair regrowth (HR) and was conducted in a predominantly taxane (T) treated population. We conducted an RCT of SC in a setting of anthracycline (A) and taxane chemotherapy (CT) and assessed its effect on CIA and HR.
METHODS


Non-metastatic breast cancer women undergoing (neo) adjuvant CT were randomized to receive SC using the Paxman scalp cooling system during every cycle of CT, or no SC. The primary end point (PEP) was successful hair preservation (HP) assessed clinically and by review of photographs after CT. HR was assessed at 6 and 12 weeks.
RESULTS


51 patients were randomized to SC (34) or control arm (17) in a 2:1 ratio. Twenty-five (49%) patients received A followed by T and the two arms were balanced with respect to this factor. HP rate was significantly higher in SC arm compared to control arm (56.3% vs 0%, P = 0.000004). HR was higher in SC arm compared to control at 6 weeks (89% vs 12%; P < 0.001) and 12 weeks (100% vs 59%, P = 0.0003). Loss of hair at PEP evaluation, which was a quality of life measure, was significantly lower in SC versus control arm (45% vs 82%, P = 0.016). There were no grade 3-4 cold related adverse effects.
CONCLUSIONS


Women with breast cancer receiving A or T chemotherapy receiving SC were significantly more likely to have less than 50% hair loss after CT, superior hair regrowth and improvement in patient reported outcomes, with acceptable tolerance. It merits wider usage.",2020,"Loss of hair at PEP evaluation, which was a quality of life measure, was significantly lower in SC versus control arm (45% vs 82%, P = 0.016).","['51 patients', 'Non-metastatic breast cancer women undergoing (neo) adjuvant CT', 'Women with breast cancer receiving A or']","['scalp cooling', 'SC using the Paxman scalp cooling system during every cycle of CT, or no SC', 'T chemotherapy receiving SC', 'scalp cooling (SC', 'anthracycline (A) and taxane chemotherapy (CT']","['quality of life measure', 'HP rate', 'hair regrowth (HR', 'alopecia', 'HR', 'Loss of hair at PEP evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C4304352', 'cui_str': 'Scalp cooling system'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0455074', 'cui_str': 'Scalp cooling (procedure)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",51.0,0.229968,"Loss of hair at PEP evaluation, which was a quality of life measure, was significantly lower in SC versus control arm (45% vs 82%, P = 0.016).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bajpai', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India. Electronic address: dr_jyotibajpai@yahoo.co.in.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kagwade', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dandekar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kanan', 'Affiliation': 'Statistician Department, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kembhavi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghosh', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Banavali', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2019.12.004']
373,32178498,Prospective Comparative Analysis of the Incidence of Vasovagal Reaction and the Effect of Rectal Submucosal Lidocaine Injection in Stapled Hemorrhoidopexy: A Randomized Controlled Trial.,"PURPOSE


This study was performed to evaluate the incidence of vasovagal reactions (VVRs) and the efficacy of lidocaine injection for prevention.
METHODS


One hundred seventeen patients diagnosed with hemorrhoids and scheduled to undergo a stapled hemorrhoidopexy (SH) were randomly divided according to submucosal injection to the rectum: lidocaine group (n = 53, lidocaine injected just before full closure of the stapler) and control group (n = 58). Outcomes included baseline patient characteristics (American Society of Anesthesiologists physical status classification, body mass index, diabetes mellitus, hypertension, and previous VVR history), vital signs during the operation, incidence of VVRs (hypotension, bradycardia, dizziness, diaphoresis, and nausea/vomiting), and postoperative complications (pain, bleeding, and urinary retention).
RESULTS


Baseline characteristics were similar between groups. The number of patients with lower abdominal pain after firing the stapler and incidence of dizziness were lower for the lidocaine group than for the control group (9.4% vs. 25.9%, P = 0.017; 0% vs. 8.6%, P = 0.035, respectively). However, there were no significant between-group differences in incidence of nausea and diaphoresis (0% vs. 3.4%, P = 0.172) and syncope (1.9% vs. 3.4%, P = 0.612). Fewer patients in the lidocaine group complained of postoperative pain (41.5% vs. 58.6%, P = 0.072), and these patients used analgesics less frequently than those in the control group (28.3% vs. 36.2%, P = 0.374).
CONCLUSION


Patients who received a submucosal lidocaine injection prior to SH experienced less lower abdominal pain and dizziness compared with those who received standard treatment. A larger, more detailed prospective study is needed for further analysis.",2020,"The number of patients with lower abdominal pain after firing the stapler and the incidence of dizziness were lower for the lidocaine group than for the control group (9.4% vs 25.9%, p=0.017; 0% vs 8.6%, p=0.035, respectively).","['Stapled Hemorrhoidopexy', 'Methods\n\n\nPatients (n=117) diagnosed with hemorrhoids and scheduled to undergo a']","['Rectal Submucosal Lidocaine Injection', 'submucosal lidocaine injection prior to SH', 'stapled hemorrhoidopexy (SH', 'lidocaine injection', 'lidocaine']","['nausea and diaphoresis', 'postoperative pain', 'abdominal pain and dizziness', 'baseline patient characteristics (ASA class, body mass index, diabetes mellitus, hypertension, previous VVR history), vital signs during the operation, the incidence of VVRs (hypotension, bradycardia, dizziness, diaphoresis, nausea/vomiting), and postoperative complications (pain, bleeding, urinary retention', 'incidence of vasovagal reactions (VVRs', 'syncope', 'number of patients with lower abdominal pain', 'incidence of dizziness']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C4081145', 'cui_str': 'Lidocaine Injection [Xylocaine]'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0700590', 'cui_str': 'Diaphoresis'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0518766'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0042420', 'cui_str': 'Syncope, Vasodepressor'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0232495', 'cui_str': 'Lower abdominal pain (finding)'}]",,0.0550562,"The number of patients with lower abdominal pain after firing the stapler and the incidence of dizziness were lower for the lidocaine group than for the control group (9.4% vs 25.9%, p=0.017; 0% vs 8.6%, p=0.035, respectively).","[{'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Seoul Song Do Hospital, Seoul, Korea.'}, {'ForeName': 'Do Yeon', 'Initials': 'DY', 'LastName': 'Hwang', 'Affiliation': 'Department of Surgery, Seoul Song Do Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology, Seoul Song Do Hospital, Seoul, Korea.'}, {'ForeName': 'Ki Hoon', 'Initials': 'KH', 'LastName': 'Hyun', 'Affiliation': 'Department of Surgery, Seoul Song Do Hospital, Seoul, Korea.'}, {'ForeName': 'Tae Jung', 'Initials': 'TJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Gangseo Song Do Hospital, Seoul, Korea.'}, {'ForeName': 'Duk Hoon', 'Initials': 'DH', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul Song Do Hospital, Seoul, Korea.'}]",Annals of coloproctology,['10.3393/ac.2020.02.12']
374,31775016,Intralymphatic immunotherapy in pollen-allergic young adults with rhinoconjunctivitis and mild asthma: A randomized trial.,,2020,"Four intralymphatic allergen injections for treatment of pollen allergy reduce medication use, improve symptoms and have immune modulating effects in adolescents and young adults with rhinoconjunctivitis and mild asthma due to birch or grass pollen.","['adolescents and young adults with rhinoconjunctivitis and mild asthma due to birch or grass pollen', 'pollen allergic young adults with rhinoconjunctivitis and mild asthma']",['Intralymphatic immunotherapy'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0330312', 'cui_str': 'Birch'}, {'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0032385', 'cui_str': 'Pollen Grains'}]","[{'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]",[],,0.164171,"Four intralymphatic allergen injections for treatment of pollen allergy reduce medication use, improve symptoms and have immune modulating effects in adolescents and young adults with rhinoconjunctivitis and mild asthma due to birch or grass pollen.","[{'ForeName': 'Jon R', 'Initials': 'JR', 'LastName': 'Konradsen', 'Affiliation': ""Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden; Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Grundström', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Hellkvist', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden; Department of ENT Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Thi Anh Thu', 'Initials': 'TAT', 'LastName': 'Tran', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Guro', 'Initials': 'G', 'LastName': 'Gafvelin', 'Affiliation': 'Therapeutic Immune Design Unit, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'M B Gea', 'Initials': 'MBG', 'LastName': 'Kiewiet', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Hamsten', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jiaqian', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College, London, United Kingdom; MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Parkin', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College, London, United Kingdom; MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College, London, United Kingdom; MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Hedlin', 'Affiliation': ""Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Lars-Olaf', 'Initials': 'LO', 'LastName': 'Cardell', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden; Department of ENT Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'van Hage', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden. Electronic address: Marianne.van.Hage@ki.se.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.11.017']
375,31896118,"Effects of intranasal insulin as an enhancer of fear extinction: a randomized, double-blind, placebo-controlled experimental study.","Fear-extinction based psychotherapy (exposure) is the most effective method for treating anxiety disorders. Notwithstanding, since some patients show impairments in the unlearning of fear and insufficient fear remission, there is a growing interest in using cognitive enhancers as adjuvants to exposure. As insulin plays a critical role in stress processes and acts as a memory enhancer, this study aimed to assess the capacity of intranasal insulin to augment fear extinction. A double-blind, placebo-controlled differential fear-conditioning paradigm was conducted in 123 healthy participants (63 females). Pictures of faces with neutral expressions were used as conditioned stimuli and electric shocks as unconditioned stimuli. The paradigm consisted of four phases presented on three consecutive days: acquisition (day 1), extinction (day 2), reinstatement and re-extinction (day 3). A single intranasal dose of insulin (160 IU) or placebo was applied on day 2, 45 min before fear extinction. Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings were assessed. During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group. Furthermore, a sex-specific effect was found for SCR, with women in the insulin group showing a greater decrease of differential SCR both at early extinction and at late re-extinction. Our results provide first evidence that intranasal insulin facilitates fear extinction processes and is therefore a promising adjuvant for extinction-based therapies in anxiety and related disorders. Sex-specific effects should be taken into consideration in future studies.",2020,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.",['123 healthy participants (63 females'],"['placebo-controlled differential fear-conditioning paradigm', 'insulin', 'intranasal insulin', 'Fear-extinction based psychotherapy (exposure', 'placebo']","['differential FPS', 'Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings', 'enhancer of fear extinction', 'differential SCR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",123.0,0.138692,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.","[{'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Ferreira de Sá', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany. diana.ferreira@uni-saarland.de.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Römer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Brückner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Issler', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hauck', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0593-3']
376,32173114,Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial.,"PURPOSE


To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism.
DESIGN


Prospective, multicenter clinical trial.
PARTICIPANTS


The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between -1.00 and -10.00 diopters (D), with manifest spherical equivalent (MSE) of up to -11.50 D and refractive cylinder of up to -3.00 D.
METHODS


-Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes.
MAIN OUTCOME MEASURES


Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events.
RESULTS


Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from -5.39±2.30 D at baseline to -0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from -1.53±0.70 D at baseline to -0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences.
CONCLUSIONS


Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.",2020,The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism.,"['307 astigmatic eyes enrolled in the study', 'The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism']","['small-incision lenticule extraction (SMILE', 'Small-Incision Lenticule Extraction']","['mean MSE', 'Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events', 'refractive cylinder', 'mean correction ratio of refractive cylinder', 'No loss of 2 or more lines of CDVA', 'Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder', 'visual acuity']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C1301318', 'cui_str': 'M-Manifest refraction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",357.0,0.300165,The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism.,"[{'ForeName': 'Jon G', 'Initials': 'JG', 'LastName': 'Dishler', 'Affiliation': 'Dishler Laser Institute, Greenwood Village, Colorado. Electronic address: jond@dishler.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Slade', 'Affiliation': 'Slade & Baker Vision Center, Houston, Texas.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Seifert', 'Affiliation': 'Carl Zeiss Meditec AG, Jena, Germany.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Schallhorn', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California; Carl Zeiss Meditec, Inc, Dublin, California; Optical Express, Glasgow, United Kingdom.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.010']
377,30285177,Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial.,"Importance


Despite recent studies suggesting arthroscopic partial meniscectomy (APM) is not more effective than physical therapy (PT), the procedure is still frequently performed in patients with meniscal tears.
Objective


To assess whether PT is noninferior to APM for improving patient-reported knee function in patients with meniscal tears.
Design, Setting, and Participants


Noninferiority, multicenter, randomized clinical trial conducted in 9 hospitals in the Netherlands. Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint). Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded. Recruitment took place between July 17, 2013, and November 4, 2015. Participants were followed up for 24 months (final participant follow-up, October 11, 2017).
Interventions


Three hundred twenty-one participants were randomly assigned to APM (n = 159) or a predefined PT protocol (n = 162). The PT protocol consisted of 16 sessions of exercise therapy over 8 weeks focused on coordination and closed kinetic chain strength exercises.
Main Outcomes and Measures


The primary outcome was change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100; from worse to best) from baseline over a 24-month follow-up period. The noninferiority margin was defined as a difference between treatment groups of 8 points and was assessed with a 1-sided α of .025. The primary analysis followed the intention-to-treat principle.
Results


Among 321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men). In the PT group, 47 participants (29%) had APM during the 24-month follow-up period, and 8 participants randomized to APM (5%) did not have APM. Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7). The overall between-group difference was 3.6 points (97.5% CI, -∞ to 6.5; P value for noninferiority = .001). Adverse events occurred in 18 participants in the APM group and 12 in the PT group. Repeat surgery (3 in the APM group and 1 in the PT group) and additional outpatient visits for knee pain (6 in the APM group and 2 in the PT group) were the most frequent adverse events.
Conclusions and Relevance


Among patients with nonobstructive meniscal tears, PT was noninferior to APM for improving patient-reported knee function over a 24-month follow-up period. Based on these results, PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears.
Trial Registration


ClinicalTrials.gov Identifier: NCT01850719.",2018,"Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7).","['Patients With Nonobstructive Meniscal Tears', 'patients with meniscal tears', '9 hospitals in the Netherlands', 'Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint', 'Interventions\n\n\nThree hundred twenty-one participants', 'patients with nonobstructive meniscal tears', 'Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded', '321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men']","['APM', 'exercise therapy', 'arthroscopic partial meniscectomy (APM', 'Early Surgery vs Physical Therapy', 'predefined PT protocol', 'PT']","['APM', 'Adverse events', 'Knee Function', 'change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100', 'knee function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",161.0,0.109593,"Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7).","[{'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Julia C A', 'Initials': 'JCA', 'LastName': 'Noorduyn', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke W', 'Initials': 'NW', 'LastName': 'Willigenburg', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ise K', 'Initials': 'IK', 'LastName': 'Butter', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'de Gast', 'Affiliation': 'Department of Orthopedic Surgery, Clinical Orthopedic Research Center-mN, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel B F', 'Initials': 'DBF', 'LastName': 'Saris', 'Affiliation': 'Department of Orthopedic Surgery, UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'currently with Department of Clinical Epidemiology and Biostatistics, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2018.13308']
378,32180059,"Counting fast or slow, aloud or silently? A comparison of adult stutterers and non-stutterers.","This study assesses factors influencing the capacity to maintain a steady rhythm during explicit counting activities. There are three counting paces (count every 800, 1200, or 1600 ms) and three experimental conditions (count silently, aloud and aloud in the presence of someone). The study also assesses the effect of a speech disorder, namely stuttering, on this counting ability by comparing the performance of a group of adult stutterers (n = 21) to that of a group of adult non-stutterers (n = 24). For temporal variability, in addition to replicating the fact that counting more slowly leads to lower performance, the results show that there are benefits to expect when participants count aloud instead of silently. There is no main effect of group, but the interaction between the experimental condition, the counting pace, and the group is significant. Adult non-stutterers are better than adult stutterers in the silent and long time-interval conditions (1600 ms). The significantly higher variability at 1600 ms indicates a loss of efficiency in the capacity to keep time constant when counting is slow, and it is in this condition that stutterers will gain the most benefits from counting aloud instead of silently.",2020,Adult non-stutterers are better than adult stutterers in the silent and long time-interval conditions (1600 ms).,['group of adult stutterers (n\u2009=\u200921) to that of a group of adult non-stutterers (n\u2009=\u200924'],[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0368474,Adult non-stutterers are better than adult stutterers in the silent and long time-interval conditions (1600 ms).,"[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Plamondon', 'Affiliation': 'École de Psychologie, Université Laval, 2325 Rue des Bibliothèques, Quebec, QC, G1V 0A6, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Grondin', 'Affiliation': 'École de Psychologie, Université Laval, 2325 Rue des Bibliothèques, Quebec, QC, G1V 0A6, Canada. simon.grondin@psy.ulaval.ca.'}]",Cognitive processing,['10.1007/s10339-020-00955-x']
379,30052722,Assessing Individual and Disseminated Effects in Network-Randomized Studies.,"Implementation trials often involve clustering via risk networks, where only some participants directly receive the intervention. The individual effect is that among directly treated persons beyond being in an intervention network; the disseminated effect is that among persons engaged with those directly treated. In this article, we employ a causal inference framework and discuss assumptions and estimators for individual and disseminated effects and apply them to the HIV Prevention Trials Network 037 Study. HIV Prevention Trials Network 037 was a phase III, network-level, randomized controlled human immunodeficiency virus (HIV) prevention trial conducted in the United States and Thailand from 2002 to 2006 that recruited injection drug users, who were assigned to either an intervention group or a control group, and their risk network members, who received no direct intervention. Combining individual and disseminated effects, we observed a 35% composite rate reduction in the adjusted model (risk ratio = 0.65, 95% confidence interval: 0.47, 0.90). Methodology is now available for estimating the full set of these effects, enhancing knowledge gained from network-randomized trials. Although the overall effect gains validity from network randomization, we show that it will generally be less than the composite effect. Additionally, if only index participants benefit from the intervention, as the network size increases, the overall effect tends toward the null-an unfortunate and misleading conclusion.",2018,"Combining individual and disseminated effects, we observed a 35% composite rate reduction in the adjusted model (risk ratio = 0.65, 95% confidence interval: 0.47, 0.90).","['HIV Prevention Trials Network 037 was a phase III, network-level, randomized controlled human immunodeficiency virus (HIV) prevention trial conducted in the United States and Thailand from 2002 to 2006 that recruited injection drug users']","['control group, and their risk network members, who received no direct intervention']",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0556025', 'cui_str': 'Injecting drug user (finding)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",[],,0.0966215,"Combining individual and disseminated effects, we observed a 35% composite rate reduction in the adjusted model (risk ratio = 0.65, 95% confidence interval: 0.47, 0.90).","[{'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Buchanan', 'Affiliation': 'Department of Pharmacy Practice, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island.'}, {'ForeName': 'Sten H', 'Initials': 'SH', 'LastName': 'Vermund', 'Affiliation': 'Vanderbilt Institute for Global Health and Department of Pediatrics, School of Medicine, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Friedman', 'Affiliation': 'Institute for Infectious Disease Research, National Development and Research Institutes, Inc., New York, New York.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Departments of Epidemiology, Biostatistics, Nutrition, and Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",American journal of epidemiology,['10.1093/aje/kwy149']
380,32170453,Arthroscopic repair of partial-thickness articular surface rotator cuff tears: single-row transtendon technique versus double-row suture bridge (transosseous equivalent) fixation: results from a prospective randomized study.,"BACKGROUND


The purpose of this prospective study was to compare the clinical and structural findings following the arthroscopic repair of partial-thickness (exceeding 50%) articular-sided rotator cuff tears using either a single-row or a double-row suture bridge fixation.
MATERIALS AND METHODS


Fifty patients were included in this study. The patients were randomly placed into two groups: 25 underwent the single-row (Group I) and 25 a double-row suture bridge fixation (Group II). The clinical outcomes were assessed using ASES and Constant shoulder scores, both preoperatively and at the end of follow-up. The pain level was evaluated using the visual analogue scale (VAS), preoperatively, at 6 months and at the end of follow-up. All patients underwent preoperative MRI to identify the rotator cuff tear, and postoperatively at 12 months to evaluate tendon integrity.
RESULTS


The average follow-up was 32.5 months. The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II. There were no significant differences between the two groups. The average preoperative pain level decreased from 7.4 to 3 at 6 months and to 0.4 at the end of the Group I; and from 7.6 to 3 at 6 months and 0.8 in Group II. There was no significant difference between the two groups. At 12 months, the MRI assessments showed two retears in Group I (8%) and one retear in Group II (4%).
CONCLUSION


Arthroscopic repair of partial-thickness articular rotator cuff tears that exceed 50% of tendon thickness with a single-row transtendon repair or double-row suture bridge provides functional improvement and pain relief regardless of the repair technique used. There were no differences in clinical results between both techniques.
LEVEL OF EVIDENCE


Level II; prospective comparative study.",2020,The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II.,"['arthroscopic repair of partial-thickness (exceeding 50', 'Fifty patients were included in this study']","['double-row suture bridge fixation', 'Arthroscopic repair of partial-thickness articular rotator cuff tears', 'single-row transtendon technique versus double-row suture bridge (transosseous equivalent) fixation', 'articular-sided rotator cuff tears using either a single-row or a double-row suture bridge fixation', 'Arthroscopic repair of partial-thickness articular surface rotator cuff tears']","['average preoperative pain level', 'MRI assessments', 'mean Constant shoulder scores', 'pain level', 'ASES and Constant shoulder scores', 'mean ASES scores', 'visual analogue scale (VAS']","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",50.0,0.0221552,The mean ASES scores increased from 35.9 to 96.7 in Group I and from 35.3 to 93.4 in Group II; the mean Constant shoulder scores increased from 55.6 to 97.8 in Group I and from 57.5 to 97.3 in Group II.,"[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zafra', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Uceda', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain. ucedasan@gmail.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Muñoz-Luna', 'Affiliation': 'Reina Sofía University Hospital, Avda. Menéndez Pidal, 14004, Córdoba, Spain.'}, {'ForeName': 'Rafael C', 'Initials': 'RC', 'LastName': 'Muñoz-López', 'Affiliation': 'Hospital Quirón, Instituto de Traumatología, Avda. del Aeropuerto, 14005, Córdoba, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Font', 'Affiliation': 'IMIBIC, Universidad de Córdoba, Córdoba, Spain.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03387-6']
381,31163231,Efficacy and safety of a novel topical minocycline foam for the treatment of moderate to severe acne vulgaris: A phase 3 study.,"BACKGROUND


FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).
OBJECTIVE


To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.
METHODS


A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a ≥2-grade improvement).
RESULTS


There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P < .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P < .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated.
LIMITATIONS


The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.
CONCLUSION


FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.",2020,FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P<.0001) and a greater rate of IGA treatment success (P<.0001) vs foam vehicle group at week 12.,"['subjects with mild AV', '1488 subjects were in the intent-to-treat population', 'Moderate-to-Severe Acne Vulgaris']","['minocycline', 'Novel Topical Minocycline Foam', 'FMX101']","['effective and safe', 'absolute change in inflammatory lesion count', 'rate of IGA treatment success', 'number of inflammatory lesions', 'efficacy and safety', 'Efficacy and Safety', 'safe and well-tolerated']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1488.0,0.209026,FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P<.0001) and a greater rate of IGA treatment success (P<.0001) vs foam vehicle group at week 12.,"[{'ForeName': 'Tooraj Joseph', 'Initials': 'TJ', 'LastName': 'Raoof', 'Affiliation': 'T. Joseph Raoof MD Inc/Encino Research Center, Encino, CA.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Hooper', 'Affiliation': 'Delricht Research, New Orleans, LA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Moore', 'Affiliation': 'Arlington Research Center, Arlington, TX; Baylor University Medical Center, Dallas, TX.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Zaiac', 'Affiliation': 'Department of Dermatology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL; Greater Miami Skin and Laser Center, Miami Beach, FL.'}, {'ForeName': 'Tory', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'Sullivan Dermatology, North Miami Beach, FL.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lain', 'Affiliation': 'Austin Institute for Clinical Research, Austin, TX.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Jankicevic', 'Affiliation': 'Foamix Pharmaceuticals, Inc., Bridgewater, NJ.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Stuart', 'Affiliation': 'Foamix Pharmaceuticals, Inc., Bridgewater, NJ. Electronic address: iain.stuart@foamix.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.05.078']
382,32167794,The effects of active acupuncture and placebo acupuncture on insomnia patients: a randomized controlled trial.,"The purpose of this study was to observe and compare the clinical efficacy of active acupuncture and placebo acupuncture in the treatment of insomnia and mood disorders. 96 patients with insomnia in Chengdu were randomly divided into two groups (1:1). The active acupuncture group (AA group n = 48) received the tube of Park sham device with deep needle insertion. The placebo acupuncture group (PA group n = 48) received the tube of Park sham device with a retractable needle shaft and a blunt tip. The same acupuncture points and treatment cycles were used in both groups. The overall score for the Pittsburgh Sleep Quality Index (PSQI) is the primary outcome. Secondary outcomes recorded sleep rate, self-reported depression scale (SDS), self-assessment anxiety scale (SAS), the 'six component' scores of PSQI, and  'Deqi'  scale scores. Eventually, 90 patients completed the study. After 2 weeks of treatment, the total score of PSQI in the AA group was 4.6 ± 2.4 and in the PA group was 12.9 ± 1.8 ( ES  = 3.91,  p  < .1). The SAS, SDS score in the AA group were 39.9 ± 5.6/39.9 ± 5.9 and in the PA group were 59.7 ± 6.1/61.2 ± 4.4 ( ES  = 3.38/4.9,  p  < .1). The sleep rate were 93.8% and 25.0% ( p  < .1). During the 1 month follow-up period, the PSQI total score in the AA group (5.2 ± 1.9) was superior to the PA group (13.1 ± 1.8) ( ES  = 4.27,  p  < .1). The SAS, SDS score in the AA group were 40.4 ± 5.1/42.7 ± 6.6 and in the PA group were 63.7 ± 6.6/63.5 ± 4.8 ( ES  = 3.95/3.60,  p  < .1). Throughout the study period, the 'six component' scores of PSQI in the AA group was superior to the PA group (each  p  < .1). Except for tingling and cooling, other acupuncture sensations were significant differences (each  p  < .1). Compared to the placebo acupuncture, active acupuncture can significantly improve insomnia, and clinical efficacy is maintained for at least 6 weeks.",2020,"Except for tingling and cooling, other acupuncture sensations were significant differences (each  p  < .1).","['96 patients with insomnia in Chengdu', 'insomnia patients', '90 patients completed the study', 'insomnia and mood disorders']","['tube of Park sham device with a retractable needle shaft and a blunt tip', 'active acupuncture and placebo acupuncture', 'tube of Park sham device with deep needle insertion', 'placebo acupuncture, active acupuncture', 'placebo acupuncture']","[""sleep rate, self-reported depression scale (SDS), self-assessment anxiety scale (SAS), the 'six component' scores of PSQI, and  'Deqi'  scale scores"", 'sleep rate', 'overall score for the Pittsburgh Sleep Quality Index (PSQI', 'PSQI total score', 'SAS, SDS score', 'insomnia, and clinical efficacy', 'total score of PSQI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}]","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}]",96.0,0.0440144,"Except for tingling and cooling, other acupuncture sensations were significant differences (each  p  < .1).","[{'ForeName': 'Leixiao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Traditional Chinese Medicine Rehabilitation, Chongqing Emergency Medical Center , Chongqing, China.'}, {'ForeName': 'Ruting', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': ""Rehabilitation Department, Chengdu First People's Hospital , Chengdu, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Nephropathy Department, Sichuan Second Chinese Medicine Hospital , Chengdu, China.'}, {'ForeName': 'Yunzhou', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Qianhua', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Youping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine , Chengdu, China.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1738015']
383,32173113,Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial.,"PURPOSE


Injection of pharmacotherapy into the suprachoroidal space, between the sclera and choroid, is an alternative delivery technique developed with the rationale of providing higher drug concentrations to posterior ocular structures compared with other intraocular and periocular injection procedures. This study was conducted to evaluate the safety and efficacy of suprachoroidally injected triamcinolone acetonide formulation (CLS-TA), a suspension of triamcinolone acetonide, in improving vision among patients with noninfectious uveitis complicated by macular edema (ME).
DESIGN


Phase 3 masked, randomized trial.
PARTICIPANTS


One hundred sixty patients with ME secondary to noninfectious uveitis. Patients were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40) in the study eye.
METHODS


Patients were randomized 3:2 to suprachoroidally injected CLS-TA or sham treatment, with administrations at day 0 and week 12.
MAIN OUTCOME MEASURES


The primary end point was improvement from baseline of 15 or more ETDRS letters in BCVA at week 24. The secondary end point was reduction from baseline in central subfield thickness (CST) at week 24.
RESULTS


In the CLS-TA arm, 47% of patients gained 15 or more ETDRS letters in BCVA versus 16% in the control arm (P < 0.001), meeting the primary end point. Mean reductions in CST from baseline were 153 μm versus 18 μm (P < 0.001). No serious adverse events (AEs) related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively).
CONCLUSIONS


Patients in the CLS-TA study arm experienced clinically significant improvement in vision relative to the sham procedure, demonstrating the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder.",2020,"Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively.","['Macular Edema Secondary to Noninfectious Uveitis', 'Patients were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40) in the study eye', 'One hundred sixty patients with ME secondary to noninfectious uveitis', 'Patients', 'patients with noninfectious uveitis complicated by macular edema (ME']","['Suprachoroidal CLS-TA', 'triamcinolone acetonide formulation (CLS-TA', 'triamcinolone acetonide', 'CLS-TA']","['Mean reductions in CST', 'vision relative', 'baseline of 15 or more ETDRS letters in BCVA', 'elevated intraocular pressure', 'Cataract AE rates', 'safety and efficacy', 'central subfield thickness (CST']","[{'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",160.0,0.133388,"Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Yeh', 'Affiliation': 'Emory Eye Center, Emory University School of Medicine, Atlanta, Georgia; Emory Global Health Institute, Emory University, Atlanta, Georgia. Electronic address: syeh3@emory.edu.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Henry', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Wang', 'Affiliation': 'Texas Retina Associates, Dallas, Texas.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Kissner', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Ciulla', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Noronha', 'Affiliation': 'Clearside Biomedical, Inc., Alpharetta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.01.006']
384,31907027,Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial.,"BACKGROUND


Scalp acupuncture has been widely used as treatment for motor dysfunction in children with cerebral palsy in China. Previous studies have failed to provide high-quality evidence to demonstrate the effectiveness of this treatment in children with cerebral palsy. No high-quality randomized controlled trials on scalp acupuncture have been published. The aim of this study is to evaluate the effectiveness of Jiao's scalp acupuncture when combined with routine rehabilitation treatment versus routine rehabilitation treatment alone for motor dysfunction in children with cerebral palsy.
METHODS/DESIGN


This is a four-centre randomized controlled trial. One hundred cerebral palsy patients with motor dysfunction were enrolled. Patients will be allocated in a 1:1 ratio into either an acupuncture treatment group or a control group. Cerebral palsy patients in the control group will receive conventional rehabilitation treatment, whereas patients in the acupuncture group will receive a combination of scalp acupuncture and conventional rehabilitation treatment. Thirty-six treatment sessions will be performed over a 12-week period. The Gross Motor Function Measure and the Fine Motor Function Measure Scale will be assessed as the primary outcome measures. The Paediatric Evaluation of Disability Inventory and the Cerebral Palsy Quality of Life Questionnaire for Children will be selected as secondary outcome measures. All assessments will be conducted at baseline, week 4 (treatment 12), week 8 (treatment 24), week 12 (treatment 36) and week 24 (follow-up).
DISCUSSION


This is the first trial evaluating the efficacy and safety of scalp acupuncture as a treatment for motor dysfunction in children with cerebral palsy. The results of this trial are expected to provide relevant evidence demonstrating that scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in children with cerebral palsy.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03921281. Registered on 19 April 2019.",2020,This is the first trial evaluating the efficacy and safety of scalp acupuncture as a treatment for motor dysfunction in children with cerebral palsy.,"['Cerebral palsy patients', 'children with cerebral palsy', 'children with cerebral palsy in China', 'One hundred cerebral palsy patients with motor dysfunction were enrolled']","['acupuncture treatment group or a control group', 'conventional rehabilitation treatment', 'scalp acupuncture', 'Acupuncture', ""Jiao's scalp acupuncture"", 'routine rehabilitation treatment', 'Scalp acupuncture', 'acupuncture group will receive a combination of scalp acupuncture and conventional rehabilitation treatment']","['efficacy and safety', 'Gross Motor Function Measure and the Fine Motor Function Measure Scale', 'Cerebral Palsy Quality of Life Questionnaire']","[{'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",100.0,0.0848211,This is the first trial evaluating the efficacy and safety of scalp acupuncture as a treatment for motor dysfunction in children with cerebral palsy.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Rehabilitation, Children's Hospital, Fudan University, Shanghai, 201102, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': ""Department of Rehabilitation, Children's Hospital, Fudan University, Shanghai, 201102, China.""}, {'ForeName': 'Dhiaedin', 'Initials': 'D', 'LastName': 'Khiati', 'Affiliation': 'School of Medicine, Royal College of Surgeons in Ireland - Medical University of Bahrain, Adilya, 15503, Bahrain.'}, {'ForeName': 'Bingpei', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': ""Department of Rehabilitation, Children's Hospital, Fudan University, Shanghai, 201102, China.""}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""Department of Rehabilitation, Children's Hospital, Fudan University, Shanghai, 201102, China.""}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': ""Department of Rehabilitation, Children's Hospital, Fudan University, Shanghai, 201102, China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Clinical Trial Unit, Children's Hospital, Fudan University, Shanghai, 201102, China.""}, {'ForeName': 'Rencai', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': ""Department of Rehabilitation, The 445th Hospital of Chinese People's Liberation Army, Shanghai, 200052, China.""}, {'ForeName': 'Huayu', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation, Huajing Community Health Service Centre of Xuhui District, Shanghai, 200231, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, Jiangchuan Community Health Service Centre of Minhang District, Shanghai, 201100, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Clinical Trial Unit, Children's Hospital, Fudan University, Shanghai, 201102, China. yanwl@fudan.edu.cn.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Rehabilitation, Children's Hospital, Fudan University, Shanghai, 201102, China. hyang@shmu.edu.cn.""}]",Trials,['10.1186/s13063-019-3986-z']
385,31791824,"DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).","BACKGROUND


DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA.
OBJECTIVE


To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.
METHODS


Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (≥24 weeks).
RESULTS


Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated-treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%).
LIMITATIONS


The study population was predominantly female and white and received only a single treatment.
CONCLUSIONS


DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.",2020,DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks.,"['609 participants enrolled (405 DAXI, 204 placebo), 92% completed', 'Participants with moderate or severe glabellar lines', 'study population was predominantly female and white and received only a single treatment']","['placebo', '40 U DAXI or placebo', 'DaxibotulinumtoxinA for Injection (DAXI', 'DaxibotulinumtoxinA']","['efficacy, duration of response, and safety', 'glabellar line severity and maintained none or mild glabellar line severity', 'Glabellar line severity', 'tolerated-treatment-related adverse effects', 'injection site pain']","[{'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}]",609.0,0.672154,DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks.,"[{'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Bertucci', 'Affiliation': 'Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; private practice, Woodbridge, Ontario, Canada. Electronic address: vince.bertucci@utoronto.ca.'}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': 'Division of Dermatology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': 'Skin Associates of South Florida, Coral Gables, and Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Coral Gables, California.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Yoelin', 'Affiliation': 'private practice, Newport Beach, California.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Shamban', 'Affiliation': 'private practice, Santa Monica, California.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Schlessinger', 'Affiliation': 'Skin Specialists PC, Omaha, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Snyder', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Gallagher', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Shears', 'Affiliation': 'Write on Target Ltd, Leighton Buzzard, United Kingdom.'}, {'ForeName': 'Roman G', 'Initials': 'RG', 'LastName': 'Rubio', 'Affiliation': 'Revance Therapeutics, Inc, Newark, California.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.06.1313']
386,32176321,Neuromonitored Thyroid Surgery: Optimal Stimulation Based on Intraoperative EMG Response Features.,"OBJECTIVES


To evaluate/compare normative electrophysiologic electromyography (EMG) response characteristics of recurrent laryngeal, vagus, and external branch of superior laryngeal nerve evoked with different stimulators used in neuromonitored thyroid surgery.
STUDY DESIGN


Prospective crossover study METHODS: EMG responses obtained via endotracheal tube surface electrodes in 11 patients undergoing thyroid surgery were recorded when stimulated with four stimulators: two monopolar (Prass standard and ball tip), one bipolar, and one dissecting instrument. Normative mean EMG results including latency, amplitude, threshold, saturation currents, and distance-sensitivity were compared.
RESULTS


The Prass standard stimulator had shorter latency time when nerve was not covered with fascia (P = .04). The bipolar, dissecting instrument, and ball tip demonstrated similar latency times with and without nerve fascia. Pooled mean latency increased significantly from 1.86 ms to 2.16 ms when comparing nerves without fascia and nerves with fascia (P < .05). The Prass standard monopolar stimulator had the lowest mean threshold at 0.40 mA, with the dissecting instrument having the highest threshold at 0.89 mA for dissected nerve. Pooled mean threshold and saturation increased from 0.6 mA to 1.7 mA (P < .0001) and 1.57 mA to 4.15 mA (P < .001) with fascia covering nerve, respectively. The mean depolarization rate was 100% for monopolar and bipolar electrodes and 81% for dissecting instrument at 1 mA. Only 9% of monopolar electrodes generated an EMG response when stimulated from 2 mm away.
CONCLUSION


Monopolar stimulators are more sensitive for neural mapping, whereas bipolar instruments are more specific, thus reducing false positive stimulation. Dissecting instruments share many features of monopolar stimulators while being more specific, and thus are a viable alternative.
LEVEL OF EVIDENCE


2b Laryngoscope, 2020.",2020,The Prass standard stimulator had shorter latency time when nerve was not covered with fascia (P = .04).,['11 patients undergoing thyroid surgery'],['EMG responses obtained via endotracheal tube surface electrodes'],"['latency, amplitude, threshold, saturation currents, and distance-sensitivity', 'Pooled mean latency', 'mean depolarization rate', 'EMG response', 'shorter latency time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0442465', 'cui_str': 'Via endotracheal tube (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}]","[{'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",11.0,0.0329686,The Prass standard stimulator had shorter latency time when nerve was not covered with fascia (P = .04).,"[{'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Abt', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Sidharth V', 'Initials': 'SV', 'LastName': 'Puram', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery and Department of Genetics, Washington University School of Medicine, St. Louis, Missouri, U.S.A.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Kamani', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Modi', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, U.S.A.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Randolph', 'Affiliation': 'Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28613']
387,32171815,Efficacy of targeted education in reducing topical steroid phobia: A randomized clinical trial.,"BACKGROUND


Fear of adverse effects of corticosteroids is common in dermatology and results in medication nonadherence.
OBJECTIVE


To study the efficacy of targeted education in reducing topical steroid phobia.
METHODS


In this double-blinded, randomized controlled trial, participants in the intervention arm were presented with an educational video and patient information leaflet targeting common misconceptions of topical corticosteroids. Steroid phobia was assessed with the topical corticosteroid phobia (TOPICOP) scale, medication adherence with the Elaboration d'un outil d'evaluation de l'observance des traitements medicamenteux (ECOB) score, and quality of life with the Dermatology Life Quality Index (DLQI).
RESULTS


The study randomized 275 patients. The mean TOPICOP score in the intervention arm decreased (improved) from 41.9 (SD, 17.4) to 37.1 (SD, 20.0) and to 33.8 (SD, 19.0) at 1 month and 3 months, respectively, with the reduction arising from the knowledge domain but not the fears and behaviors domain. This remained statistically significant after adjusting for demographic confounding with an expected reduction of 4.22 points (P = .031). After accounting for demographic factors, there was no statistical difference in medication adherence and quality of life. Limitations include the exclusion of non-English-speaking patients.
CONCLUSION


Targeted education at a single time point improved the TOPICOP score primarily in the knowledge domain but not in the fear domain.",2020,"© score in the intervention arm decreased (improved) from 41.9 (SD,17.4) to 37.1 (SD,20.0) and 33.8 (SD,19.0) at 1 month and 3 months, respectively with the reduction arising from the knowledge domain but not the fears and behaviours domain.",['275 patients were randomised'],"['TOPICOP', 'educational video and patient information leaflet targeting common misconceptions of topical corticosteroids', 'corticosteroids', 'Targeted Education']","['Mean (SD) TOPICOP', 'medication adherence and quality of life', '© scale, medication adherence with the ECOB score, and quality of life with the DLQI', 'Steroid phobia']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0034380'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]",275.0,0.151103,"© score in the intervention arm decreased (improved) from 41.9 (SD,17.4) to 37.1 (SD,20.0) and 33.8 (SD,19.0) at 1 month and 3 months, respectively with the reduction arising from the knowledge domain but not the fears and behaviours domain.","[{'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Choi', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore. Electronic address: ellie_choi@nuhs.edu.sg.'}, {'ForeName': 'Ken Wei', 'Initials': 'KW', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Fengjie', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tan', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore.'}, {'ForeName': 'Nisha Suyien', 'Initials': 'NS', 'LastName': 'Chandran', 'Affiliation': 'Division of Dermatology, Department of Medicine, National University Health System, Singapore.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.079']
388,32162279,Effectiveness of sleep surgery versus a mandibular advancement device for obstructive sleep apnea in terms of nocturnal cardiac autonomic activity.,"PURPOSE


Sleep surgery and mandibular advancement devices (MAD) are treatments for obstructive sleep apnea (OSA), but their comparative efficacy remains unclear. We compared their efficacy using various parameters.
METHODS


Subjects treated for OSA with sleep surgery or MAD (n = 30/group)-matched for sex, body mass index (BMI), and baseline apnea-hypopnea index (AHI)-were enrolled. The efficacy of these treatments according to polysomnographic parameters, sleep quality questionnaires, and heart rate variability (HRV) time- and frequency-domain parameters were compared between pre-treatment and 3-month post-treatment.
RESULTS


Polysomnographic and sleep quality questionnaire parameters improved significantly in both groups. In time-domain HRV analysis, average normal-to-normal intervals increased significantly in the surgery (942.2 ± 140.8 to 994.6 ± 143.1, P = 0.008) and MAD (901.1 ± 131.7 to 953.7 ± 123.1, P = 0.002) groups. Low frequency (LF) decreased significantly in the surgery group (P = 0.012); high frequency (HF) remained unchanged in both groups. The LF/HF ratio decreased in both groups (2.9 ± 1.8 to 2.3 ± 1.7, P = 0.017, vs. 3.0 ± 1.8 to 2.4 ± 1.4, P = 0.025). Normalized high frequency increased significantly in both groups (31.0 ± 13.2 to 36.8 ± 13.7, P = 0.009, vs. 29.1 ± 10.7 to 33.7 ± 12.5, P = 0.024), in contrast to normalized low frequency. However, no HRV parameter changes differed significantly between the groups after adjusting for age, BMI, and AHI.
CONCLUSION


Sleep surgery and MAD are equally effective treatments for OSA according to cardiac autonomic activity.",2020,Low frequency (LF) decreased significantly in the surgery group (P = 0.012); high frequency (HF) remained unchanged in both groups.,"['obstructive sleep apnea (OSA', 'Subjects treated for OSA with sleep surgery or MAD (n\xa0=\u200930/group)-matched for sex, body mass index (BMI), and baseline apnea-hypopnea index (AHI)-were enrolled']","['mandibular advancement device', 'sleep surgery', 'Sleep surgery and mandibular advancement devices (MAD']","['Normalized high frequency', 'Polysomnographic and sleep quality questionnaire parameters', 'HRV parameter changes', 'nocturnal cardiac autonomic activity', 'obstructive sleep apnea', 'average normal-to-normal intervals', 'LF/HF ratio', 'polysomnographic parameters, sleep quality questionnaires, and heart rate variability (HRV) time- and frequency-domain parameters', 'Low frequency (LF']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]","[{'cui': 'C0376461', 'cui_str': 'Mandibular Advancement'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0671759', 'cui_str': 'MAD'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]",,0.013085,Low frequency (LF) decreased significantly in the surgery group (P = 0.012); high frequency (HF) remained unchanged in both groups.,"[{'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Kangwon National University Hospital, Chuncheon, South Korea.'}, {'ForeName': 'Sung Ok', 'Initials': 'SO', 'LastName': 'Kwon', 'Affiliation': 'Biomedical Research Institute, Kangwon National University Hospital, Chuncheon, South Korea.'}, {'ForeName': 'Jeong-Whun', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology, Seoul National University Bundang Hospital, 82 Gumi-ro 173th street, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea. kimemails7@gmail.com.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02048-7']
389,32164428,Headache and non-headache symptoms provoked by nitroglycerin in migraineurs: A human pharmacological triggering study.,"BACKGROUND


Studying a spontaneous migraine attack is challenging, particularly the earliest components. Nitroglycerin is a potent, reliable and reproducible migraine trigger of the entirety of the migraine attack, making its use experimentally attractive.
METHODS


Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms were exposed to a 0.5 mcg/kg/min nitroglycerin infusion. Eighty-three percent (n = 44) developed typical premonitory and headache symptomatology. Fifty-seven percent (n = 25) were invited back to further study visits, during which they were re-exposed to nitroglycerin or placebo infusion in a double-blind randomised design. The phenotype of premonitory symptoms and headache was captured and compared to spontaneous attacks and between triggered attacks using agreement analysis.
RESULTS


More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001). The agreement in triggering for the most commonly reported premonitory symptoms (concentration difficulty and tiredness) was >66%. The retriggering agreement for all but one premonitory symptom was >60%. The agreement in timing to onset of premonitory symptoms was reliable across two triggered attacks. The agreement with spontaneous attacks and between attacks for headache and its associated symptoms, including laterality, was less reliable.
CONCLUSIONS


Nitroglycerin can reliably and reproducibly provoke premonitory symptomatology associated with migraine. This forms an ideal model to study the earliest manifestations of migraine attacks.",2020,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001).","['Eighty-three percent (n\u2009', 'migraineurs', 'Fifty-three subjects with migraine with a history of spontaneous premonitory symptoms', 'Fifty-seven percent (n\u2009']","['nitroglycerin or placebo infusion', 'nitroglycerin infusion', 'placebo', 'Nitroglycerin', 'nitroglycerin']","['Headache', 'typical premonitory and headache symptomatology']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0240805', 'cui_str': 'Prodrome'}, {'cui': 'C4517815', 'cui_str': '57'}]","[{'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",53.0,0.162561,"More premonitory symptoms were triggered with nitroglycerin than placebo (mean symptom difference = 4,  t 20  = 7.06,  p  < 0.001).","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jayde', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102420910114']
390,32164442,Effects of a naturalistic intervention on the speech outcomes of young children with cleft palate.,"Purpose : The purpose of this study was to investigate the extent to which a naturalistic communication intervention, Enhanced Milieu Teaching with Phonological Emphasis (EMT + PE) improved the speech outcomes of toddlers with cleft palate with or without cleft lip (CP ± L) Method : This study was a stratified randomised controlled trial.Setting: Treatment was delivered in a university clinic by a trained speech-language pathologist.Thirty children aged between 15 and 36 months ( M  = 25) with nonsyndromic CP ± CL and typical cognitive development were randomly assigned to a treatment (EMT + PE) or business as usual comparison condition.Participants in the EMT + PE treatment group received 48, 30-min sessions, over a 6-month period. Fidelity of treatment was high across participants.The primary outcome measures were percent consonants correct (PCC), consonant inventory, compensatory articulation errors, and nasal emission. Result : Regression analyses controlling for pre-intervention child characteristics were conducted for PCC and consonant inventory. Intervention was not a significant predictor of post-intervention outcome. Words per minute differentiated the children who benefitted from the intervention from those who did not. Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group. Conclusion : EMT + PE is a promising early speech intervention for young children with CP ± L, especially for children with higher rates of word use.",2020,Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group.,"['Thirty children aged between 15 and 36 months ( M \u2009=\u200925) with nonsyndromic CP\u2009±\u2009CL and typical cognitive development', 'toddlers with cleft palate with or without cleft lip (CP\u2009±\u2009L', 'young children with cleft palate', 'Participants ']","['treatment (EMT\u2009+\u2009PE) or business as usual comparison condition', 'EMT\u2009+\u2009PE', 'naturalistic communication intervention, Enhanced Milieu Teaching with Phonological Emphasis (EMT\u2009+\u2009PE', 'naturalistic intervention']","['compensatory errors and nasal emission', 'percent consonants correct (PCC), consonant inventory, compensatory articulation errors, and nasal emission']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0008924', 'cui_str': 'Harelip'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.0718014,Reduction in compensatory errors and nasal emission occurred in both groups but to a greater degree in the EMT + PE group.,"[{'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Scherer', 'Affiliation': 'Department of Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Ann P', 'Initials': 'AP', 'LastName': 'Kaiser', 'Affiliation': 'Department of Special Education, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Frey', 'Affiliation': 'Department of Special Education and Disability Studies, The George Washington University, Washington, DC, USA, and.'}, {'ForeName': 'Hope Sparks', 'Initials': 'HS', 'LastName': 'Lancaster', 'Affiliation': 'Department of Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Department of Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Megan Y', 'Initials': 'MY', 'LastName': 'Roberts', 'Affiliation': 'School of Communication, Northwestern University, Evanston, IL, USA.'}]",International journal of speech-language pathology,['10.1080/17549507.2019.1702719']
391,31963239,Trimethylamine- N -Oxide Postprandial Response in Plasma and Urine Is Lower After Fermented Compared to Non-Fermented Dairy Consumption in Healthy Adults.,"Trimethylamine- N -oxide (TMAO) can be produced by the gut microbiota from dietary substrates and is associated with cardiovascular disease. While dairy products contain TMAO precursors, the effect of fermented dairy on TMAO metabolism remains unclear. We used plasma and urine samples collected for two randomised cross-over studies to evaluate the effects of fermented dairy consumption on TMAO metabolism. In Study 1, thirteen healthy young men tested a yogurt and an acidified milk during postprandial tests and a two-week daily intervention. In Study 2, ten healthy adults tested milk and cheese during postprandial tests. TMAO and five related metabolites were measured in plasma and urine by LC-MS/MS and NMR. Faecal microbiota composition was assessed in Study 1 (16S rRNA metagenomics sequencing). Fermented milk products were associated with lower postprandial TMAO responses than non-fermented milks in urine (Study 1,  p  = 0.01; Study 2,  p  = 0.02) and in plasma, comparing yogurt and acidified milk (Study 1,  p  = 0.04). Daily consumption of dairy products did not differentially affect fasting TMAO metabolites. Significant correlations were observed between microbiota taxa and circulating or urinary TMAO concentrations. Fermentation of dairy products appear, at least transiently, to affect associations between dairy products and circulating TMAO levels.",2020,"Fermented milk products were associated with lower postprandial TMAO responses than non-fermented milks in urine (Study 1,  p  = 0.01; Study 2,  p  = 0.02) and in plasma, comparing yogurt and acidified milk (Study 1,  p  = 0.04).","['Healthy Adults', 'ten healthy adults tested milk and cheese during postprandial tests', 'thirteen healthy young men tested a yogurt and an acidified milk during postprandial tests and a two-week daily intervention']","['N -oxide (TMAO', 'Trimethylamine', 'fermented dairy consumption']","['microbiota taxa and circulating or urinary TMAO concentrations', 'TMAO metabolism', 'Faecal microbiota composition', 'postprandial TMAO responses', 'fasting TMAO metabolites']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",13.0,0.0279664,"Fermented milk products were associated with lower postprandial TMAO responses than non-fermented milks in urine (Study 1,  p  = 0.01; Study 2,  p  = 0.02) and in plasma, comparing yogurt and acidified milk (Study 1,  p  = 0.04).","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Burton', 'Affiliation': 'Federal Department of Economic Affairs, Education and Research EAER, Agroscope, CH-3003 Bern, Switzerland.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Krüger', 'Affiliation': 'Max Rubner-Institut, Physiology and Biochemistry of Nutrition, D-76131 Karlsruhe, Germany.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Scherz', 'Affiliation': 'Institute of Microbiology, Lausanne University Hospital and Lausanne University, CH-1011 Lausanne, Switzerland.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Münger', 'Affiliation': 'Federal Department of Economic Affairs, Education and Research EAER, Agroscope, CH-3003 Bern, Switzerland.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Picone', 'Affiliation': 'Department of Agricultural and Food Sciences (DISTAL), University of Bologna, I-47521 Cesena, Italy.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Vionnet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, CH-1011 Lausanne, Switzerland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bertelli', 'Affiliation': 'Institute of Microbiology, Lausanne University Hospital and Lausanne University, CH-1011 Lausanne, Switzerland.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Greub', 'Affiliation': 'Institute of Microbiology, Lausanne University Hospital and Lausanne University, CH-1011 Lausanne, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Capozzi', 'Affiliation': 'Department of Agricultural and Food Sciences (DISTAL), University of Bologna, I-47521 Cesena, Italy.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vergères', 'Affiliation': 'Federal Department of Economic Affairs, Education and Research EAER, Agroscope, CH-3003 Bern, Switzerland.'}]",Nutrients,['10.3390/nu12010234']
392,32166837,Effect of 12 weeks continuous positive airway pressure on day and night arterial stiffness and blood pressure in patients with type 2 diabetes and obstructive sleep apnea: A randomized controlled trial.,"The objective of this study was to evaluate the effect of continuous positive airway pressure treatment on pulse wave velocity and blood pressure in patients with type 2 diabetes and obstructive sleep apnea. A randomized controlled study was performed, including 72 patients with type 2 diabetes and newly diagnosed obstructive sleep apnea recruited from outpatient clinics at three Danish hospitals. The patients were randomized to continuous positive airway pressure for 12 weeks or no continuous positive airway pressure. Office measurements were performed at baseline, 4 weeks and 12 weeks. At baseline and 12 weeks, a 24-hr measurement of pulse wave velocity and blood pressure was performed. No significant change was observed in the primary outcome variable of carotid-femoral pulse wave velocity measured with SphygmoCor. With the Mobil-O-Graph, changes in office pulse wave velocity between the groups were significant: 0.3 m/s; 95% confidence interval, 0.1-0.6; p = .02. The group receiving continuous positive airway pressure had a larger decrease in pulse wave velocity than controls but none of the changes within the groups were significant. No significant change in ambulatory blood pressure was observed in any of the two groups after 12 weeks. In conclusion, continuous positive airway pressure treatment for 12 weeks does not significantly reduce pulse wave velocity or blood pressure in patients with type 2 diabetes and obstructive sleep apnea.",2020,"With the Mobil-O-Graph, changes in office pulse wave velocity between the groups were significant: 0.3 m/s;","['patients with type 2 diabetes and obstructive sleep apnea', '72 patients with type 2 diabetes and newly diagnosed obstructive sleep apnea recruited from outpatient clinics at three Danish hospitals']","['continuous positive airway pressure treatment', '12\xa0weeks continuous positive airway pressure', 'continuous positive airway pressure for 12\xa0weeks or no continuous positive airway pressure']","['pulse wave velocity', 'pulse wave velocity or blood pressure', 'pulse wave velocity and blood pressure', 'carotid-femoral pulse wave velocity', 'blood pressure', '24-hr measurement of pulse wave velocity and blood pressure', 'ambulatory blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]",72.0,0.0285687,"With the Mobil-O-Graph, changes in office pulse wave velocity between the groups were significant: 0.3 m/s;","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Krogager', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anne Margareta', 'Initials': 'AM', 'LastName': 'Banghøj', 'Affiliation': 'Department of Cardiology, Nephrology and Endocrinology, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Per L', 'Initials': 'PL', 'LastName': 'Poulsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Kirkegaard', 'Affiliation': 'Elective Surgery Centre, Sleep Disorders Clinic, Regional Hospital Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Birger', 'Initials': 'B', 'LastName': 'Thorsteinsson', 'Affiliation': 'Department of Cardiology, Nephrology and Endocrinology, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Department of Cardiology, Nephrology and Endocrinology, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Klavs W', 'Initials': 'KW', 'LastName': 'Hansen', 'Affiliation': 'Diagnostic Centre, Regional Hospital Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Laugesen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Journal of sleep research,['10.1111/jsr.12978']
393,32074268,Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known.
Objective


To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis.
Interventions


Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day.
Design, Setting, and Participants


This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019.
Main Outcomes and Measures


In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated.
Results


Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment.
Conclusions and Relevance


In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy.
Trial Registration


Clinicaltrials.gov Identifier: NCT01022567.",2020,"The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96).","['530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or', '530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent', '81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment', 'uncomplicated acute appendicitis', 'Patients with appendectomy or with', 'Uncomplicated Acute Appendicitis', '206 patients taking antibiotics, 81 (39%) had undergone appendectomy']","['appendectomy and antibiotic therapy', 'successful antibiotic therapy', 'Interventions\n\n\nOpen appendectomy vs antibiotics with intravenous ertapenem', 'appendectomy with antibiotics', 'receive antibiotics', 'levofloxacin', 'metronidazole', 'appendectomy', 'Antibiotic Therapy vs Appendectomy', 'antibiotic therapy and appendectomy']","['quality of life (QOL', 'patient satisfaction', 'QOL', 'Quality of Life and Patient Satisfaction', 'postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1120106', 'cui_str': 'ertapenem'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",530.0,0.154225,"The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96).","[{'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Sippola', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Haijanen', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Viinikainen', 'Affiliation': 'Department of Surgery, University of Turku, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Grönroos', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Paajanen', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Aarnio', 'Affiliation': 'Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Hurme', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Mecklin', 'Affiliation': 'Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Sand', 'Affiliation': 'Department of Health and Medical Services, Päijät-Häme Joint Authority for Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Jartti', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Salminen', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2019.6028']
394,32162075,Unguided Chatbot-Delivered Cognitive Behavioural Intervention for Problem Gamblers Through Messaging App: A Randomised Controlled Trial.,"Internet-delivered intervention may be an acceptable alternative for the more than 90% of problem gamblers who are reluctant to seek face-to-face support. Thus, we aimed to (1) develop a low-dropout unguided intervention named GAMBOT integrated with a messaging app; and (2) investigate its effect. The present study was a randomised, quadruple-blind, controlled trial. We set pre-to-post change in the Problem Gambling Severity Index (PGSI) as the primary outcome and pre-to-post change in the Gambling Symptom Assessment Scale (G-SAS) as a secondary outcome. Daily monitoring, personalised feedback, and private messages based on cognitive behavioural theory were offered to participants in the intervention group through a messaging app for 28 days (GAMBOT). Participants in the control group received biweekly messages only for assessments for 28 days (assessments only). A total of 197 problem gamblers were included in the primary analysis. We failed to demonstrate a significant between-group difference in the primary outcome (PGSI - 1.14, 95% CI - 2.75 to 0.47, p = 0.162) but in the secondary outcome (G-SAS - 3.14, 95% CI - 0.24 to - 6.04, p = 0.03). Only 6.7% of the participants dropped out during follow-up and 77% of the GAMBOT group participants (74/96) continued to participate in the intervention throughout the 28-day period. Integrating intervention into a chatbot feature on a frequently used messaging app shows promise in helping to overcome the high dropout rate of unguided internet-delivered interventions. More effective and sophisticated contents delivered by a chatbot should be sought to engage over 90% of problem gamblers who are reluctant to seek face-to-face support.",2020,"Daily monitoring, personalised feedback, and private messages based on cognitive behavioural theory were offered to participants in the intervention group through a messaging app for 28 days (GAMBOT).",['197 problem gamblers'],"['Messaging App', 'Unguided Chatbot-Delivered Cognitive Behavioural Intervention']","['Gambling Symptom Assessment Scale (G-SAS', 'Problem Gambling Severity Index (PGSI']","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]",[],"[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",197.0,0.144034,"Daily monitoring, personalised feedback, and private messages based on cognitive behavioural theory were offered to participants in the intervention group through a messaging app for 28 days (GAMBOT).","[{'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Okayama Psychiatric Medical Center, 3-16 Shikatahon-machi, Kita-ku, Okayama, 700-0915, Japan. nexttext@gmail.com.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Sachio', 'Initials': 'S', 'LastName': 'Matsushita', 'Affiliation': 'Department of Psychiatry, National Hospital Organization Kurihama Medical and Addiction Center, Yokosuka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'Bureau of International Health Cooperation, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Matsuzaki', 'Affiliation': 'Department of Psychiatry, National Hospital Organization Kurihama Medical and Addiction Center, Yokosuka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Furuno', 'Affiliation': 'Department of Psychiatry, National Hospital Organization Kurihama Medical and Addiction Center, Yokosuka, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Psychiatry, National Hospital Organization Kurihama Medical and Addiction Center, Yokosuka, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Higuchi', 'Affiliation': 'Department of Psychiatry, National Hospital Organization Kurihama Medical and Addiction Center, Yokosuka, Japan.'}]",Journal of gambling studies,['10.1007/s10899-020-09935-4']
395,31952131,"Effects of Daily Low-Dose Date Consumption on Glycemic Control, Lipid Profile, and Quality of Life in Adults with Pre- and Type 2 Diabetes: A Randomized Controlled Trial.","Dates have a low glycemic index and are a source of antioxidants but, nevertheless, contain more than 70% sugar. This study aims to assess the effects of date consumption (three dates daily) on glycemic profile (HbA1c), body mass index (BMI), quality of life, and lipid profile, including total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) in terms of safety for type 2 diabetic mellitus (T2DM) subjects. A randomized controlled trial was conducted with a sample of 100 T2DM subjects (39 male and 61 female) randomly assigned in two groups. The first group received three dates daily for 16 weeks, and the control group avoided date consumption. After a 16-week follow-up period, the study results showed an improvement of lipid profile with a statistically significant decrease in total cholesterol of ∆ = -0.209 mmol/L (confidence interval (CI) 95% -0.358, -0.059;  p  < 0.05) and in LDL of ∆ = -0.171 mmol/L (CI 95% -0.358, 0.016) in the group receiving three dates daily. Intra-group mean differences of BMI were not statistically different in both groups after 16 weeks of date consumption. Even HbA1c did not change, both within and between groups after date consumption (∆ = 0.087%; CI 95% -0.086, 0.261). Between groups, mean difference changes (intervention minus control) showed a statistically significant improvement of quality of life index of ∆ = ± 30.66 points (CI 95% 12.45, 48.23) due to the consequent improvement in mental health. Although the definitive effect of dose/intake response of date consumption on Hb1Ac, lipid profile, and BMI in T2DM subjects is still to be established, the study suggests that dates could potentially have a beneficial effect on lipid profile, especially in reducing total cholesterol and elevating HDL, because of its high polyphenolic content. In addition, a low-moderate consumption of dates did not impact glucose levels because of dates' low glycemic index.",2020,"Between groups, mean difference changes (intervention minus control) showed a statistically significant improvement of quality of life index of ∆ = ± 30.66 points (CI 95% 12.45, 48.23) due to the consequent improvement in mental health.","['100 T2DM subjects (39 male and 61 female', 'Adults with Pre- and Type 2 Diabetes', 'type 2 diabetic mellitus (T2DM) subjects']",['Daily Low-Dose Date Consumption'],"['Glycemic Control, Lipid Profile, and Quality of Life', 'BMI', 'glycemic profile (HbA1c), body mass index (BMI), quality of life, and lipid profile, including total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL', 'mental health', 'quality of life index', 'total cholesterol', 'lipid profile']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0034380'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}]",39.0,0.119875,"Between groups, mean difference changes (intervention minus control) showed a statistically significant improvement of quality of life index of ∆ = ± 30.66 points (CI 95% 12.45, 48.23) due to the consequent improvement in mental health.","[{'ForeName': 'Tariq A', 'Initials': 'TA', 'LastName': 'Alalwan', 'Affiliation': 'Department of Biology, College of Science, University of Bahrain, P.O. Box 32038, Sakhir, Bahrain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, College of Science, University of Bahrain, P.O. Box 32038, Sakhir, Bahrain.'}, {'ForeName': 'Qaher A', 'Initials': 'QA', 'LastName': 'Mandeel', 'Affiliation': 'Department of Biology, College of Science, University of Bahrain, P.O. Box 32038, Sakhir, Bahrain.'}, {'ForeName': 'Aalaa', 'Initials': 'A', 'LastName': 'Abdulhadi', 'Affiliation': 'Department of Biology, College of Science, University of Bahrain, P.O. Box 32038, Sakhir, Bahrain.'}, {'ForeName': 'Adel Salman', 'Initials': 'AS', 'LastName': 'Alsayyad', 'Affiliation': 'Public Health Directorate, Ministry of Health, Manama, Bahrain.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': ""D'Antona"", 'Affiliation': 'CRIAMS-Sport Medicine Centre, University of Pavia, 27058 Voghera, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Negro', 'Affiliation': 'CRIAMS-Sport Medicine Centre, University of Pavia, 27058 Voghera, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Riva', 'Affiliation': 'Research and Development Department, Indena SpA, 20139 Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrangolini', 'Affiliation': 'Research and Development Department, Indena SpA, 20139 Milan, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Allegrini', 'Affiliation': 'Research and Development Department, Indena SpA, 20139 Milan, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, 27100 Pavia, Italy.'}]",Nutrients,['10.3390/nu12010217']
396,31952249,"Effects of Synbiotic Supplement on Human Gut Microbiota, Body Composition and Weight Loss in Obesity.","Targeting gut microbiota with synbiotics (probiotic supplements containing prebiotic components) is emerging as a promising intervention in the comprehensive nutritional approach to reducing obesity. Weight loss resulting from low-carbohydrate high-protein diets can be significant but has also been linked to potentially negative health effects due to increased bacterial fermentation of undigested protein within the colon and subsequent changes in gut microbiota composition. Correcting obesity-induced disruption of gut microbiota with synbiotics can be more effective than supplementation with probiotics alone because prebiotic components of synbiotics support the growth and survival of positive bacteria therein. The purpose of this placebo-controlled intervention clinical trial was to evaluate the effects of a synbiotic supplement on the composition, richness and diversity of gut microbiota and associations of microbial species with body composition parameters and biomarkers of obesity in human subjects participating in a weight loss program. The probiotic component of the synbiotic used in the study contained  Lactobacillus acidophilus ,  Bifidobacterium lactis ,  Bifidobacterium   longum , and  Bifidobacterium bifidum  and the prebiotic component was a galactooligosaccharide mixture. The results showed no statistically significant differences in body composition (body mass, BMI, body fat mass, body fat percentage, body lean mass, and bone mineral content) between the placebo and synbiotic groups at the end of the clinical trial (3-month intervention, 20 human subjects participating in weight loss intervention based on a low-carbohydrate, high-protein, reduced energy diet). Synbiotic supplementation increased the abundance of gut bacteria associated with positive health effects, especially  Bifidobacterium  and  Lactobacillus , and it also appeared to increase the gut microbiota richness. A decreasing trend in the gut microbiota diversity in the placebo and synbiotic groups was observed at the end of trial, which may imply the effect of the high-protein low-carbohydrate diet used in the weight loss program. Regression analysis performed to correlate abundance of species following supplementation with body composition parameters and biomarkers of obesity found an association between a decrease over time in blood glucose and an increase in  Lactobacillus  abundance, particularly in the synbiotic group. However, the decrease over time in body mass, BMI, waist circumstance, and body fat mass was associated with a decrease in  Bifidobacterium  abundance. The results obtained support the conclusion that synbiotic supplement used in this clinical trial modulates human gut microbiota by increasing abundance of potentially beneficial microbial species.",2020,"A decreasing trend in the gut microbiota diversity in the placebo and synbiotic groups was observed at the end of trial, which may imply the effect of the high-protein low-carbohydrate diet used in the weight loss program.",['human subjects participating in a weight loss program'],"['placebo', 'Synbiotic supplementation', 'synbiotics (probiotic supplements containing prebiotic components', 'synbiotic supplement', 'Synbiotic Supplement']","['gut microbiota richness', 'abundance of gut bacteria', 'Human Gut Microbiota, Body Composition and Weight Loss in Obesity', 'gut microbiota diversity', 'time in body mass, BMI, waist circumstance, and body fat mass', 'body composition (body mass, BMI, body fat mass, body fat percentage, body lean mass, and bone mineral content', 'Weight loss', 'blood glucose']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",20.0,0.0166408,"A decreasing trend in the gut microbiota diversity in the placebo and synbiotic groups was observed at the end of trial, which may imply the effect of the high-protein low-carbohydrate diet used in the weight loss program.","[{'ForeName': 'Igor N', 'Initials': 'IN', 'LastName': 'Sergeev', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD 57007, USA.'}, {'ForeName': 'Thamer', 'Initials': 'T', 'LastName': 'Aljutaily', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD 57007, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Walton', 'Affiliation': 'Department of Food and Nutritional Sciences, University of Reading, Reading RG6 6AP, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Huarte', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD 57007, USA.'}]",Nutrients,['10.3390/nu12010222']
397,31952280,Lactobacillus reuteri DSM 17938 and Magnesium Oxide in Children with Functional Chronic Constipation: A Double-Blind and Randomized Clinical Trial.,"OBJECTIVE


Chronic functional constipation is a frequent condition. The aim of the study was to evaluate the efficacy of the probiotic Lactobacillus (L.) reuteri DSM 17938 and magnesium oxide (MgO) for relieving chronic functional constipation in children.
STUDY DESIGN


A prospective, double-blind, placebo-controlled, randomized, and parallel-group trial was conducted in five pediatric outpatient clinics in Japan. Sixty patients who were more than six months old and under six years of age with a diagnosis of functional constipation according to Rome IV criteria were randomly divided into three groups: group A (n = 20) received L. reuteri DSM 17938 and lactose hydrate as a placebo of MgO; group B (n = 19) received L. reuteri DSM 17938 and MgO; and group C (n = 21) received a placebo of L. reuteri DSM 17938 and MgO.
RESULTS


All three groups exhibited significant improvement in defecation frequency in the fourth week compared with the baseline condition (group A: p < 0.05; group B: p < 0.05; group C: p < 0.05). The MgO group and combination group showed a significant decrease in stool consistency, but the L. reuteri DSM 17938 group did not (group A: p = 0.079; group B: p < 0.05; group C: p < 0.05). MgO significantly suppressed the presence of the genus Dialister. Defecation frequency negatively correlated with the frequency of Clostridiales-belonging bacteria among the gut microbiome.
CONCLUSIONS


L. rueteri DSM 17938 and MgO were both effective in the management of functional constipation in young children. MgO caused an imbalance in the gastrointestinal microbiome, which was not the case in the probiotic group.",2020,L. rueteri DSM 17938 and MgO were both effective in the management of functional constipation in young children.,"['children', 'Sixty patients who were more than six months old and under six years of age with a diagnosis of functional constipation according to Rome IV criteria', 'young children', 'five pediatric outpatient clinics in Japan', 'Children with Functional Chronic Constipation']","['placebo', 'L. reuteri DSM 17938 and MgO', 'L. reuteri DSM 17938 and lactose hydrate as a placebo of MgO', 'placebo of L. reuteri DSM 17938 and MgO.\nRESULTS', 'probiotic Lactobacillus (L.) reuteri DSM 17938 and magnesium oxide (MgO', 'Lactobacillus reuteri DSM 17938 and Magnesium Oxide']","['defecation frequency', 'stool consistency', 'Defecation frequency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}]","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",60.0,0.0504522,L. rueteri DSM 17938 and MgO were both effective in the management of functional constipation in young children.,"[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Kubota', 'Affiliation': ""Kubota Children's Clinic, 2-6-18 Katsuyamakita Ikunoku, Osaka, 544-0033, Japan.""}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi Abenoku, Osaka, 545-0051, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tomimoto', 'Affiliation': 'Tomimoto Pediatric Clinic, 6-6-20 Minatotakadai, Hachinohe, 031-0823, Japan.'}, {'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Kanazaki', 'Affiliation': ""Kanazaki Children's Clinic, 3323 Dotocho Nakaku, Sakai, 599-8234, Japan.""}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Tsukiyama', 'Affiliation': 'Tsukiyama Child Care Clinic, 484 Akizuki, Wakayama, 640-8322, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Kubota', 'Affiliation': 'Tsukiyama Child Care Clinic, 484 Akizuki, Wakayama, 640-8322, Japan.'}, {'ForeName': 'Haruo', 'Initials': 'H', 'LastName': 'Kuroki', 'Affiliation': ""Sotobo Children's Clinic, 1880-4 Izumi Misakicho, Isumi, 299-4503, Japan.""}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Department of Microbiology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Osakasayama,589-8511, Japan.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Vandenplas', 'Affiliation': 'KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, 1090 Brussels, Belgium.'}]",Nutrients,['10.3390/nu12010225']
398,32102807,Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss.,"OBJECTIVES


To examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men.
DESIGN


Individually randomised three-arm feasibility trial with 12 months' follow-up.
SETTING


Two sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD).
PARTICIPANTS


Men with obesity (n=105) recruited through community outreach and general practitioner registers.
INTERVENTIONS


Participants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control.
OUTCOMES


Acceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months.
RESULTS


105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: -2.51 kg (SD=4.94); SMS only: -1.29 kg (SD=5.03); control: -0.86 kg (SD=5.64) at 12 months).
CONCLUSIONS


This three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver.
TRIAL REGISTRATION NUMBER


NCT03040518.",2020,The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30).,"['engage men with obesity in text message and incentive interventions for weight loss', 'Two sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD', '105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2', 'men', 'Men with obesity (n=105) recruited through community outreach and general practitioner registers', 'Eleven SMS+I participants (31%) successfully met or partially met weight loss targets']","['narrative text messages with or without financial incentives', 'narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control']","['Acceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3178909'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}]",105.0,0.177374,The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30).,"[{'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Department of Kinesiology, University of New Brunswick Fredericton, Fredericton, New Brunswick, Canada stephan.dombrowski@unb.ca.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'van der Pol', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Grindle', 'Affiliation': 'Institute for Health Research and Innovation, University of the Highlands and Islands, Inverness, Highland, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carroll', 'Affiliation': 'Mens Health Forum in Ireland, Dublin, Ireland.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Calveley', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Glennie', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Harris', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hapca', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Health Informatics Centre, University of Dundee, Dundee, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'McKinley', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Skinner', 'Affiliation': 'Division of Psychology, University of Stirling, Stirling, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tod', 'Affiliation': ""Men's Health Forum, London, UK.""}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Hoddinott', 'Affiliation': 'Nursing, Midwifery and Allied Health Professional Research Unit, University of Stirling, Stirling, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032653']
399,31907019,"Effects of school-based physical activity and multi-micronutrient supplementation intervention on growth, health and well-being of schoolchildren in three African countries: the KaziAfya cluster randomised controlled trial protocol with a 2 × 2 factorial design.","BACKGROUND


In low- and middle-income countries, infectious diseases remain a key public health issue. Additionally, non-communicable diseases are a rapidly growing public health problem that impose a considerable burden on population health. One way to address this dual disease burden, is to incorporate (lifestyle) health promotion measures within the education sector. In the planned study, we will (i) assess and compare physical activity, physical fitness, micronutrient status, body composition, infections with soil-transmitted helminths, Schistosoma mansoni, malaria, inflammatory and cardiovascular health risk markers, cognitive function, health-related quality of life, and sleep in schoolchildren in Côte d'Ivoire, South Africa and Tanzania. We will (ii) determine the bi- and multivariate associations between these variables and (iii) examine the effects of a school-based health intervention that consists of physical activity, multi-micronutrient supplementation, or both.
METHODS


Assuming that no interaction occurs between the two interventions (physical activity and multi-micronutrient supplementation), the study is designed as a cluster-randomised, placebo-controlled trial with a 2 × 2 factorial design. Data will be obtained at three time points: at baseline and at 9 months and 21 months after the baseline assessment. In each country, 1320 primary schoolchildren from grades 1-4 will be recruited. In each school, classes will be randomly assigned to one of four interventions: (i) physical activity; (ii) multi-micronutrient supplementation; (iii) physical activity plus multi-micronutrient supplementation; and (iv) no intervention, which will serve as the control. A placebo product will be given to all children who do not receive multi-micronutrient supplementation. After obtaining written informed consent from the parents/guardians, the children will be subjected to anthropometric, clinical, parasitological and physiological assessments. Additionally, fitness tests will be performed, and children will be invited to wear an accelerometer device for 7 days to objectively assess their physical activity. Children infected with S. mansoni and soil-transmitted helminths will receive deworming drugs according to national policies. Health and nutrition education will be provided to the whole study population independently of the study arm allocation.
DISCUSSION


The study builds on the experience and lessons of a previous study conducted in South Africa. It involves three African countries with different social-ecological contexts to investigate whether results are generalisable across the continent.
TRIAL REGISTRATION


The study was registered on August 9, 2018, with ISRCTN. https://doi.org/10.1186/ISRCTN29534081.",2020,"It involves three African countries with different social-ecological contexts to investigate whether results are generalisable across the continent.
","['1320 primary schoolchildren from grades 1-4 will be recruited', ""schoolchildren in Côte d'Ivoire, South Africa and Tanzania"", 'schoolchildren in three African countries', 'Children infected with S. mansoni and soil-transmitted helminths', 'South Africa']","['placebo', 'school-based physical activity and multi-micronutrient supplementation intervention', 'physical activity; (ii) multi-micronutrient supplementation; (iii) physical activity plus multi-micronutrient supplementation; and (iv) no intervention']","['physical activity, physical fitness, micronutrient status, body composition, infections with soil-transmitted helminths, Schistosoma mansoni, malaria, inflammatory and cardiovascular health risk markers, cognitive function, health-related quality of life, and sleep']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0454695', 'cui_str': 'African country (geographic location)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0349450', 'cui_str': 'Soiling (finding)'}, {'cui': 'C0018893', 'cui_str': 'Worms, Parasitic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0349450', 'cui_str': 'Soiling (finding)'}, {'cui': 'C0018893', 'cui_str': 'Worms, Parasitic'}, {'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",1320.0,0.126746,"It involves three African countries with different social-ecological contexts to investigate whether results are generalisable across the continent.
","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland. markus.gerber@unibas.ch.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Ayekoé', 'Affiliation': ""Institut National de la Jeunesse et des Sports, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Beckmann', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bassirou', 'Initials': 'B', 'LastName': 'Bonfoh', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Jean T', 'Initials': 'JT', 'LastName': 'Coulibaly', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Dao', 'Initials': 'D', 'LastName': 'Daouda', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'du Randt', 'Affiliation': 'Nelson Mandela University, Port Elizabeth, South Africa.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Finda', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam/Ifakara, Tanzania.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Gall', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Getrud J', 'Initials': 'GJ', 'LastName': 'Mollel', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam/Ifakara, Tanzania.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Kurt Z', 'Initials': 'KZ', 'LastName': 'Long', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Ludyga', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Honorati', 'Initials': 'H', 'LastName': 'Masanja', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam/Ifakara, Tanzania.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Müller', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Siphesihle', 'Initials': 'S', 'LastName': 'Nqweniso', 'Affiliation': 'Nelson Mandela University, Port Elizabeth, South Africa.'}, {'ForeName': 'Fredros', 'Initials': 'F', 'LastName': 'Okumu', 'Affiliation': 'Ifakara Health Institute, Dar es Salaam/Ifakara, Tanzania.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Probst-Hensch', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Steinmann', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Sylvain G', 'Initials': 'SG', 'LastName': 'Traoré', 'Affiliation': ""Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Nelson Mandela University, Port Elizabeth, South Africa.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Utzinger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}]",Trials,['10.1186/s13063-019-3883-5']
400,31587995,"Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial.","INTRODUCTION


Alzheimer's disease (AD) is a disabling, common cause of dementia, and agitation is one of the most common and distressing symptoms for patients with AD. Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.
METHODS


S-CitAD is a NIH-funded, investigator-initiated, randomized, multicenter clinical trial. Participants receive a structured psychosocial intervention (PSI) as standard of care. Participants without sufficient response to PSI are randomized to receive 15 mg escitalopram/day or a matching placebo in addition to PSI. Primary outcome is the Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC).
DISCUSSION


S-CitAD will provide information about a practical, immediately available approach to treating agitation in patients with AD. S-CitAD may become a model of how to evaluate and predict treatment response in patients with AD and agitation as a neuropsychiatric symptom (ClinicalTrials.gov Identifier: NCT03108846).",2019,"Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.
","['patients with AD', ""Alzheimer's disease (S-CitAD"", 'Participants without sufficient response to PSI']","['Escitalopram', 'structured psychosocial intervention (PSI', '15\xa0mg escitalopram/day or a matching placebo']","[""Modified Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (mADCS-CGIC""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.488123,"Escitalopram for agitation in Alzheimer's disease (S-CitAD) tests a novel, clinically derived therapeutic approach to treat agitation in patients with AD.
","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: sehrhar6@jhu.edu.'}, {'ForeName': 'Anton P', 'Initials': 'AP', 'LastName': 'Porsteinsson', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Munro', 'Affiliation': 'Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Pollock', 'Affiliation': 'Campbell Family Research Institute and Division of Adult Neurodevelopment and Geriatric Psychiatry, CAMH, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Davangere P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Division of Geriatric Psychiatry, New York State Psychiatric Institute and College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Mintzer', 'Affiliation': 'Roper St. Francis Research and Innovation Center, Charleston, SC, USA; Medical University of South Carolina, College of Health Professionals and Ralph H Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Campbell Family Research Institute and Division of Adult Neurodevelopment and Geriatric Psychiatry, CAMH, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zahinoor', 'Initials': 'Z', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychiatry, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada; Department of Clinical Neurosciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'Departments of Psychiatry and the Behavioral Sciences and Neurology, University of Southern California Keck School of Medicine and the University of Southern California Leonard Davis School of Gerontology, Los Angeles, CA, USA; Department of Neurology, University of Southern California Keck School of Medicine and the University of Southern California Leonard Davis School of Gerontology, Los Angeles, CA, USA.'}, {'ForeName': 'Sheriza N', 'Initials': 'SN', 'LastName': 'Baksh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lea T', 'Initials': 'LT', 'LastName': 'Drye', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Avramopoulos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Institute of Genetic Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shade', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Constantine G', 'Initials': 'CG', 'LastName': 'Lyketsos', 'Affiliation': 'Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine and Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1016/j.jalz.2019.06.4946']
401,32162501,Effects of strength vs. endurance training and their combination on physical performance characteristics in female horseback riders.,"BACKGROUND


The purpose of this study was to investigate effects of strength (S), endurance (E) and concurrent strength and endurance (SE) training on neuromuscular and cardiorespiratory characteristics during the 12-week volume-equated protocols in female horseback riders.
METHODS


Subjects (N.=44) (29.4±8.9 yrs) were assigned to S (N.=11), E (N.=11), SE (N.=13) and control (C) (N.=9) groups. Training consisted of progressive S, E or SE training 3x/week and riding exercise 4-6x/week. The measurements included maximal isometric bilateral leg press force (MVCLP) and EMG of VL and BF muscles, rapid isometric force production (0-500ms), maximal force of trunk extensor/flexors (MVCE/MVCF), countermovement-jump (CMJ), maximal oxygen uptake (VO2max), cycling-time (Timemax), blood lactate (L) and heart rate (HR) in the bicycle-ergometer test.
RESULTS


Only group S showed significant increases of 9% in MVCLP (P<0.01) and 3% in MVCE (P<0.05) forces. None of the groups showed significant increases in CMJ, rapid isometric force production or EMG. Timemax in the ergometer test increased significantly in S (P<0.05), SE (P<0.05) and E (P<0.01) with significant increases in VO2max in E (P<0.05) and SE (P<0.01).
CONCLUSIONS


The present strength-training program led to the significant gain in maximal strength in S but not in SE, maybe due to some interference effects produced by the actual endurance training and riding related endurance training. All groups increased significantly Timemax but VO2max increased only in E and SE. It would be useful for female horseback riders to perform combined SE training and to perform S training periodically to insure gains in strength, when needed.",2020,"Timemax in the ergometer test increased significantly in S (p<0.05), SE (p<0.05) and E (p<0.01) with significant increases in VO2max in E (p<0.05) and SE (p<0.01).
","['Subjects (N=44) (29.4±8.9 yrs) were assigned to S (n=11), E (n=11), SE (n=13) and control (C) (n=9) groups', 'female horseback riders']","['strength vs. endurance training', 'MVCLP', 'progressive S, E or SE training 3x/week and riding exercise 4-6x/week', 'strength (S), endurance (E) and concurrent strength and endurance (SE) training']","['physical performance characteristics', 'CMJ, rapid isometric force production or EMG', 'VO2max in E (p<0.05) and SE (p<0.01', 'maximal isometric bilateral leg press force (MVCLP) and EMG of VL and BF muscles, rapid isometric force production (0-500ms), maximal force of trunk extensor/flexors (MVCE/MVCF), countermovement-jump (CMJ), maximal oxygen uptake (VO2max), cycling-time (Timemax), blood lactate (L) and heart rate (HR) in the bicycle- ergometer test', 'Timemax but VO2max']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C2607857'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer, device (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0119964,"Timemax in the ergometer test increased significantly in S (p<0.05), SE (p<0.05) and E (p<0.01) with significant increases in VO2max in E (p<0.05) and SE (p<0.01).
","[{'ForeName': 'Anne-Maarit', 'Initials': 'AM', 'LastName': 'Hyttinen', 'Affiliation': 'Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland - anne.a-m.hyttinen@jyu.fi.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'Neuromuscular Research Center, Biology of Physical Activity, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10380-3']
402,31963808,"Effects of  Lactobacillus plantarum  Q180 on Postprandial Lipid Levels and Intestinal Environment: A Double-Blind, Randomized, Placebo-Controlled, Parallel Trial.","Probiotics can improve the intestinal environment by enhancing beneficial bacteria to potentially regulate lipid levels; however, the underlying mechanisms remain unclear. The aim of this study was to investigate the effect of  Lactobacillus plantarum  Q180 (LPQ180) on postprandial lipid metabolism and the intestinal microbiome environment from a clinical perspective. A double-blind, randomized, placebo-controlled study was conducted including 70 participants of both sexes, 20 years of age and older, with healthy blood triacylglyceride (TG) levels below 200 mg/dL. Treatment with LPQ180 for 12 weeks significantly decreased LDL-cholesterol ( p  = 0.042) and apolipoprotein (Apo)B-100 ( p  = 0.003) levels, and decreased postprandial maximum concentrations (C max ) and areas under the curve (AUC) of TG, chylomicron TG, ApoB-48, and ApoB-100. LPQ180 treatment significantly decreased total indole and phenol levels ( p  = 0.019). In addition, there was a negative correlation between baseline microbiota abundance and lipid marker change, which was negatively correlated with metabolites. This study suggests that LPQ180 might be developed as a functional ingredient to help maintain healthy postprandial lipid levels through modulating gut environment.",2020,LPQ180 treatment significantly decreased total indole and phenol levels ( p  = 0.019).,"['70 participants of both sexes, 20 years of age and older, with healthy blood triacylglyceride (TG) levels below 200 mg/dL. Treatment with']","['Placebo', 'Lactobacillus plantarum  Q180 (LPQ180', 'placebo', 'LPQ180', 'Probiotics', 'Lactobacillus plantarum']","['baseline microbiota abundance and lipid marker change', 'total indole and phenol levels', 'LDL-cholesterol', 'postprandial maximum concentrations (C max ) and areas under the curve (AUC) of TG, chylomicron TG, ApoB-48, and ApoB-100', 'Postprandial Lipid Levels and Intestinal Environment', 'postprandial lipid metabolism']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021242', 'cui_str': 'Indoles'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0103839', 'cui_str': 'Chylomicron Apo B'}, {'cui': 'C0205666', 'cui_str': 'Apo-B-100'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.29853,LPQ180 treatment significantly decreased total indole and phenol levels ( p  = 0.019).,"[{'ForeName': 'Ye Eun', 'Initials': 'YE', 'LastName': 'Park', 'Affiliation': 'Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul 01811, Korea.'}, {'ForeName': 'Min Seo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul 01811, Korea.'}, {'ForeName': 'Kyung Won', 'Initials': 'KW', 'LastName': 'Shim', 'Affiliation': 'Department of Family Medicine, Ewha Womans University College of Medicine, Mokdong Hospital, Seoul 07985, Korea.'}, {'ForeName': 'You-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'Probiotics Research Laboratory, CKDBiO Research Institute, Ansan-si, Gyeonggi-do 15604, Korea.'}, {'ForeName': 'Jaeryang', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Probiotics Research Laboratory, CKDBiO Research Institute, Ansan-si, Gyeonggi-do 15604, Korea.'}, {'ForeName': 'Byoung-Kook', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Probiotics Research Laboratory, CKDBiO Research Institute, Ansan-si, Gyeonggi-do 15604, Korea.'}, {'ForeName': 'In Suk', 'Initials': 'IS', 'LastName': 'Choi', 'Affiliation': 'Probiotics Research Laboratory, CKDBiO Research Institute, Ansan-si, Gyeonggi-do 15604, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul 01811, Korea.'}]",Nutrients,['10.3390/nu12010255']
403,32167611,Randomized Controlled Trial of Comparative Hypocaloric vs Full-Energy Enteral Feeding During the First Week of Hospitalization in Neurosurgical Patients at the Intensive Care Unit.,"BACKGROUND


Nutrition support plays a pivotal role in improving the clinical outcomes of the patients admitted to the intensive care unit (ICU). However, there are controversies regarding the optimal amount of energy for the reduction of morbidity and mortality in neurosurgical patients at the ICU.
METHODS


This randomized clinical trial was conducted on 560 patients who were admitted to trauma, stroke, and neurosurgery ICUs, and 68 patients were enrolled based on the inclusion criteria. In total, data of 58 patients were analyzed. In the full-energy group, enteral feeding started at 75% of their daily energy expenditure and gradually increased to 90%-100%. In the hypocaloric group, enteral feeding started with 30% of the daily energy expenditure and reached 75% within 7 days of the intervention.
RESULTS


No significant differences were observed in the baseline characteristics of the patients in the hypocaloric and full-energy groups. The incidence of severe gastrointestinal intolerance was relatively high in the full-energy group (P < .001). Duration of mechanical ventilation and length of hospital stay were lower in the hypocaloric group compared with the full-energy group (P = .014 and P = .046, respectively). However, no significant differences were denoted in the length of ICU admission (P = .163), 28-day mortality (P = .640), and pneumonia (P = .162) between the study groups.
CONCLUSIONS


In the neurocritical care unit, hypocaloric enteral feeding was associated with lower gastrointestinal intolerance, as well as reduced duration of ventilator dependence and length of hospital stay.",2020,The incidence of severe gastrointestinal intolerance was relatively high in the full-energy group (P < .001).,"['neurosurgical patients at the ICU', '560 patients who were admitted to trauma, stroke, and neurosurgery ICUs, and 68 patients were enrolled based on the inclusion criteria', 'patients admitted to the intensive care unit (ICU', '58 patients were analyzed', 'Neurosurgical Patients at the Intensive Care Unit']",['Comparative Hypocaloric vs Full-Energy Enteral Feeding'],"['Duration of mechanical ventilation and length of hospital stay', '28-day mortality', 'length of ICU admission', 'incidence of severe gastrointestinal intolerance', 'duration of ventilator dependence and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]",560.0,0.0395744,The incidence of severe gastrointestinal intolerance was relatively high in the full-energy group (P < .001).,"[{'ForeName': 'Seyedeh Zeynab', 'Initials': 'SZ', 'LastName': 'Mousavian', 'Affiliation': 'Student Research Committee, Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Pasdar', 'Affiliation': 'Research Center for Environmental Determinants of Health (RCEDH), Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Ranjbar', 'Affiliation': 'Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sajedeh', 'Initials': 'S', 'LastName': 'Jandari', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Akhlaghi', 'Affiliation': 'Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Almasi', 'Affiliation': 'Research Center of Environmental Determinants of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Safarian', 'Affiliation': 'Metabolic Syndrome Research Center, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1782']
404,32127584,Performance of single-use syringe versus multi-use MR contrast injectors: a prospective comparative study.,"The goal of this study was to compare performance parameters of a single-use syringe and a multi-use MR contrast injector. We compared preparation time, cost for disposables and volumes of contrast material used for a single-use (SI) and a multi-use (MI) MR contrast injector in a prospective cross-over trial. During the first study period all consecutive patients eligible for dynamic MR on two systems were included during a period of 20 working days. After 10 days, the injector was switched. Radiographer satisfaction was evaluated using a questionnaire. Contrast usage and waste on system MI was optimised by extra instructions for our radiographers and measured during the second study period of 10 consecutive working days. A total of 202 and 163 patients for systems SI and MI were included, respectively. Average preparation time was 4:55 min for SI and 2:24 min for MI (p < 0.05). Contrast waste for SI was 13% using 7.5 ml syringes. Contrast waste for MI was 5% for 7.5 ml containers. Costs for disposables were lower for MI if more than 5 patients per day were injected. Radiographer satisfaction was higher for MI (4.7 versus 2.8 on a 5-point scale; p < 0.05). The multi-use MR contrast injector led to higher radiographer satisfaction, shorter preparation time, and lower cost if more than 5 patients were injected per day. In addition, cheaper contrast containers of 15 or 30 ml could be used for the first patients if more than 2 or more than 4 injections are performed per day, potentially leading to lower contrast waste.",2020,Average preparation time was 4:55 min for SI and 2:24 min for MI (p < 0.05).,"['A total of 202 and 163 patients for systems SI and MI were included, respectively', 'consecutive patients eligible for dynamic MR on two systems were included during a period of 20 working days']","['single-use (SI) and a multi-use (MI) MR contrast injector', 'single-use syringe and a multi-use MR contrast injector', 'single-use syringe versus multi-use MR contrast injectors']","['Radiographer satisfaction', 'radiographer satisfaction, shorter preparation time, and lower cost', 'Average preparation time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0181342', 'cui_str': 'Injector'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}]","[{'cui': 'C0402007', 'cui_str': 'Medical radiographer (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",202.0,0.0169529,Average preparation time was 4:55 min for SI and 2:24 min for MI (p < 0.05).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Struik', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands. struikfe@gmail.com.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Futterer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Prokop', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-60697-w']
405,31968571,Circulating Ionized Magnesium: Comparisons with Circulating Total Magnesium and the Response to Magnesium Supplementation in a Randomized Controlled Trial.,"Ionized Mg (iMg) is considered the biologically active fraction of circulating total Mg (tMg). It is possible that iMg may be a more physiologically relevant marker than tMg. Using data from a double-blind pilot randomized controlled trial, we tested (1) whether oral Mg supplementation will increase iMg concentrations compared with placebo and (2) the relationship between iMg and tMg at baseline. Additionally, we evaluated the agreement between iMg measured in fresh whole blood versus stored samples. A total of fifty-nine participants were randomized 1:1 to oral Mg supplementation (400 mg/day, Mg Oxide) or placebo for 10 weeks. Fasting blood samples were obtained at baseline and follow-up. The analysis used linear regression and an intent-to-treat approach. Participants were generally healthy, the mean age was 62, and 73% were female. The baseline iMg and tMg were modestly and positively associated (r = 0.50). The ratio of baseline iMg to tMg was 64%. The mean supplement effect on iMg was 0.03 mmol/L (95% CI:0.01, 0.05) for Mg supplementation versus placebo. The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median). Compared to fresh blood, iMg was consistently higher in refrigerated and frozen samples by 0.14 and 0.20 mmol/L, respectively. In this relatively healthy adult population, Mg supplementation over 10 weeks resulted in increased iMg concentrations. Whether iMg is a more appropriate measure of Mg status than tMg, and the public health or clinical utility of measuring iMg remains to be determined.",2020,The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median).,"['Participants were generally healthy, the mean age was 62, and 73% were female', 'A total of fifty-nine participants']","['Magnesium Supplementation', 'oral Mg supplementation', 'placebo', 'Ionized Mg (iMg', 'oral Mg supplementation (400 mg/day, Mg Oxide) or placebo']","['baseline iMg and tMg', 'Fasting blood samples', 'iMg concentrations']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}]","[{'cui': 'C1096534', 'cui_str': 'Providing magnesium based on suboptimal food or fluid intake, iatrogenic deficiency or medical diagnosis. (Source: IDNT Reference Manual, edition 4; ISBN #978-0-88091-467-3)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",59.0,0.46985,The supplement effect on iMg was not statistically significantly different according to baseline iMg status (above/below median).,"[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Rooney', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN 55454, USA, harna001@umn.edu (L.H.).'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Rudser', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA, rudser@umn.edu.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA, alvaro.alonso@emory.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Harnack', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN 55454, USA, harna001@umn.edu (L.H.).'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Saenger', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin Healthcare, Minneapolis, MN 55415, USA, amy.saenger@hcmed.org.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Lutsey', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN 55454, USA, harna001@umn.edu (L.H.).'}]",Nutrients,['10.3390/nu12010263']
406,31968595,Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial.,"Enhanced Recovery after Surgery (ERAS) with sole carbohydrate (CHO) loading and postoperative early oral feeding (POEOF)  s hortened the length of postoperative (PO) hospital stays (LPOHS) without increasing complications. This study aimed to examine the impact of ERAS with preoperative whey protein-infused CHO loading and POEOF among surgical gynecologic cancer (GC) patients. There were 62 subjects in the intervention group (CHO-P), which received preoperative whey protein-infused CHO loading and POEOF; and 56 subjects formed the control group (CO), which was given usual care. The mean age was 49.5 ± 12.2 years (CHO-P) and 51.2 ± 11.9 years (CO). The trial found significant positive results which included shorter LPOHS (78.13 ± 33.05 vs. 99.49 ± 22.54 h); a lower readmission rate within one month PO (6% vs. 16%); lower weight loss (-0.3 ± 2.3 kg vs. -2.1 ± 2.3 kg); a lower C-reactive protein-albumin ratio (0.3 ± 1.2 vs. 1.1 ± 2.6); preserved muscle mass (0.4 ± 1.7 kg vs. -0.7 ± 2.6 kg); and better handgrip strength (0.6 ± 4.3 kg vs. -1.9 ± 4.7 kg) among CHO-P as compared with CO. However, there was no significant difference in mid-upper arm circumference and serum albumin level upon discharge. ERAS with preoperative whey protein-infused CHO loading and POEOF assured better PO outcomes.",2020,"However, there was no significant difference in mid-upper arm circumference and serum albumin level upon discharge.","['Surgical Gynecologic Cancer Patients', 'The mean age was 49.5 ± 12.2 years (CHO-P) and 51.2 ± 11.9 years (CO', 'surgical gynecologic cancer (GC) patients']","['ERAS with preoperative whey protein-infused CHO loading and POEOF', 'preoperative whey protein-infused CHO loading and POEOF', 'Surgery (ERAS) with sole carbohydrate', 'Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding']","['readmission rate', 'weight loss', 'CHO) loading and postoperative early oral feeding (POEOF)  s hortened the length of postoperative (PO) hospital stays (LPOHS', 'mid-upper arm circumference and serum albumin level', 'handgrip strength']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}]",62.0,0.0194489,"However, there was no significant difference in mid-upper arm circumference and serum albumin level upon discharge.","[{'ForeName': 'Ho Chiou', 'Initials': 'HC', 'LastName': 'Yi', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia.'}, {'ForeName': 'Zuriati', 'Initials': 'Z', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia.'}, {'ForeName': 'Zalina', 'Initials': 'Z', 'LastName': 'Abu Zaid', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia.'}, {'ForeName': ""Zulfitri 'Azuan"", 'Initials': ""Z'"", 'LastName': 'Mat Daud', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia.'}, {'ForeName': 'Nor Baizura', 'Initials': 'NB', 'LastName': 'Md Yusop', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Omar', 'Affiliation': 'Department of Surgical Oncology, National Cancer Institute, Ministry of Health, 4, Jalan P7, Presint 7, Putrajaya 62250, Malaysia.'}, {'ForeName': 'Mohd Norazam', 'Initials': 'MN', 'LastName': 'Mohd Abas', 'Affiliation': 'Department of Surgical Oncology, National Cancer Institute, Ministry of Health, 4, Jalan P7, Presint 7, Putrajaya 62250, Malaysia.'}, {'ForeName': 'Zuwariah', 'Initials': 'Z', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Dietetics and Food Service, National Cancer Institute, Ministry of Health, 4, Jalan P7, Presint 7, Putrajaya 62250, Malaysia.'}, {'ForeName': 'Norshariza', 'Initials': 'N', 'LastName': 'Jamhuri', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Seri Kembangan 43400, Malaysia.'}]",Nutrients,['10.3390/nu12010264']
407,32022887,Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.,"Importance


Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone.
Objective


To assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy.
Design, Setting, and Participants


A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results.
Interventions


Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Main Outcomes and Measures


The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points.
Results


Of the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group.
Conclusions and Relevance


In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy.
Trial Registration


ClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16.",2020,"The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.","['281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses', '25 men [40%]; median [interquartile range] age, 67 [56-73] years', '281 patients undergoing partial pancreatectomy were assessed for inclusion', 'patients undergoing partial pancreatectomy', 'Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received', 'Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded', 'Patients', 'patients undergoing distal pancreatectomy', 'Pancreatic Fistula']","['hydrocortisone and pasireotide', 'pasireotide', 'Hydrocortisone vs Pasireotide', 'hydrocortisone']","['mean (SD) CCI score', 'postoperative pancreatic fistula rate', 'Postoperative pancreatic fistula', 'Comprehensive Complication Index (CCI) score', 'Pancreatic Surgery Complications', 'CCI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0161912', 'cui_str': 'Partial pancreatectomy (procedure)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy (procedure)'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",281.0,0.604697,"The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Tarvainen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Sirén', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Kokkola', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2019.6019']
408,31999300,Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy.,"Importance


Preservation of peripheral visual field (VF) is considered an advantage for anti-vascular endothelial growth factor agents compared with panretinal photocoagulation (PRP) for treatment of proliferative diabetic retinopathy. Long-term data on VF are important when considering either treatment approach.
Objective


To further evaluate changes in VF throughout 5 years among eyes enrolled in the Protocol S clinical trial, conducted by the DRCR Retina Network.
Design, Setting, and Participants


Post hoc analyses of an ancillary study within a multicenter (55 US sites) randomized clinical trial. Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included. Data were collected from February 2012 to February 2018. Analysis began in June 2018.
Interventions


Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab. Diabetic macular edema, whenever present, was treated with ranibizumab in both groups. Panretinal photocoagulation could be administered to eyes in the ranibizumab group when failure or futility criteria were met.
Main Outcomes and Measures


Mean change in total point score on VF testing with the Humphrey Field Analyzer 30-2 and 60-4 test patterns.
Results


Of 394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study. Of these, 167 (71.4%) had VF meeting acceptable quality criteria at baseline (median [interquartile range] age, 50 [43-58] years; 90 men [53.9%]). At 5 years, 79 (33.8%) had results available. The mean (SD) change in total point score in the PRP and ranibizumab groups was -305 (521) dB and -36 (486) dB at 1 year, respectively, increasing to -527 (635) dB and -330 (645) dB at 5 years, respectively (P = .04). After censoring VF results after PRP treatments in the ranibizumab group, the 5-year mean change in total point score was -201 (442) dB. In a longitudinal regression analysis of change in total point score including both treatment groups, laser treatment was associated with a mean point decrease of 208 (95% CI, 112-304) dB for the initial PRP session, 77 (95% CI, 21-132) dB for additional PRP sessions, and 325 (95% CI, 211-439) dB for endolaser. No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
Conclusions and Relevance


The limited data available from Protocol S suggest that there are factors besides PRP associated with VF loss in eyes treated for proliferative diabetic retinopathy. Further clinical research is warranted to clarify the finding.
Trial Registration


ClinicalTrials.gov identifier: NCT01489189.",2020,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
","['Proliferative Diabetic Retinopathy', '394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study', 'Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included', 'Data were collected from February 2012 to February 2018']","['Panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Panretinal Photocoagulation or Ranibizumab', 'Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab', 'ranibizumab', 'peripheral visual field (VF']","['total point score', 'mean (SD) change in total point score', 'Visual Field Changes', 'Main Outcomes and Measures\n\n\nMean change in total point score on VF testing', '5-year mean change in total point score', 'Diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]",,0.0737913,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
","[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Johnson', 'Affiliation': 'Visual Field Reading Center, University of Iowa, Iowa City.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5939']
409,29526281,Outcomes of Counseling after Education about Carrier Results: A Randomized Controlled Trial.,"In-person education and counseling for all people receiving genetic results is the predominant model of disclosure but is challenged by the growing volume of low-impact results generated by sequencing. Evidence suggests that web-based tools may be as effective as in-person counseling at educating individuals about their low-impact results. However, the effects of counseling have not been assessed. To evaluate its utility, carrier results were returned to 459 post-reproductive participants from the ClinSeq cohort within a randomized controlled trial. Participants received education and were randomized to receive counseling or not. Primary outcomes included risk worry, test-related positive experiences, attitudes, and decisional conflict. Secondary outcomes were satisfaction, preferences, and counseling value. There were no differences between participants who received counseling and those who did not in the primary outcomes. Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high. Most participants (92%) randomized to counseling preferred it and valued it because it provided validation of their reactions and an opportunity for interpersonal interaction. Web-based tools address the challenge of returning low-impact results, and these data provide empiric evidence that counseling, although preferred and satisfying, is not critical to achieving desired outcomes.",2018,"Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high.",['459 post-reproductive participants from the ClinSeq cohort within a randomized controlled trial'],[],"['satisfaction, preferences, and counseling value', 'overall satisfaction', 'risk worry, test-related positive experiences, attitudes, and decisional conflict']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}]",,0.184104,"Participants who received counseling were more satisfied than those who did not (x¯ = 10.2 and 9.5, respectively, p < 0.002, range: 3-12), although overall satisfaction was high.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Lewis', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA. Electronic address: lewiskatie@mail.nih.gov.'}, {'ForeName': 'Kendall L', 'Initials': 'KL', 'LastName': 'Umstead', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Johnston', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Ilana M', 'Initials': 'IM', 'LastName': 'Miller', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Thompson', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Kristen P', 'Initials': 'KP', 'LastName': 'Fishler', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Leslie G', 'Initials': 'LG', 'LastName': 'Biesecker', 'Affiliation': 'Medical Genomics and Metabolic Genetics Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'Barbara B', 'Initials': 'BB', 'LastName': 'Biesecker', 'Affiliation': 'Social and Behavioral Research Branch, National Human Genome Research Institute, NIH, Bethesda, MD 20892, USA. Electronic address: lesb@mail.nih.gov.'}]",American journal of human genetics,['10.1016/j.ajhg.2018.02.009']
410,31988225,Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.,"INTRODUCTION


Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and temporal distribution of daylight. The objective of this study is to investigate the antidepressant efficacy of a newly developed dynamic LED-lighting system installed in an inpatient ward.
METHODS AND ANALYSIS


In all, 150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included. The design is a two-arm 1:1 randomised study with a dynamic LED-lighting arm and a static LED-lighting arm, both as add-on to usual treatment in an inpatient psychiatric ward. The primary outcome is the baseline adjusted score on the 6-item Hamilton Depression Rating Scale at week 3. The secondary outcomes are the mean score on the Suicidal Ideation Attributes Scale at week 3, the mean score on the 17-item Hamilton Depression Rating Scale at week 3 and the mean score on the World Health Organisation Quality of Life-BREF (WHOQOL-BREF) at week 3. The spectral distribution of daylight and LED-light, with a specific focus on light mediated through the intrinsically photosensitive retinal ganglion cells, will be measured. Use of light luminaires will be logged. Assessors of Hamilton Depression Rating Scale scores and data analysts will be blinded for treatment allocation. The study was initiated in May 2019 and will end in December 2021.
ETHICS AND DISSEMINATION


No ethical issues are expected. Results will be published in peer-reviewed journals, disseminated electronically and in print and presented at symposia.
TRIAL REGISTRATION NUMBER


NCT03821506; Pre-results.",2020,No ethical issues are expected.,"['150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included', 'depressed inpatients']","['light-emitting diode (LED) technology', 'dynamic LED-lighting arm and a static LED-lighting', 'Light therapy', 'Dynamic LED-light versus static LED-light']","['17-item Hamilton Depression Rating Scale', 'baseline adjusted score on the 6-item Hamilton Depression Rating Scale', 'Hamilton Depression Rating Scale scores', 'mean score on the Suicidal Ideation Attributes Scale', 'World Health Organisation Quality of Life-BREF (WHOQOL-BREF']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023700', 'cui_str': 'Illumination'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0043236', 'cui_str': 'Healths, International'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0034380'}]",150.0,0.0695436,No ethical issues are expected.,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Volf', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Aggestrup', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Paul Michael', 'Initials': 'PM', 'LastName': 'Petersen', 'Affiliation': 'Department of Photonics Engineering, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Dam-Hansen', 'Affiliation': 'Department of Photonics Engineering, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Knorr', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ema Erkocevic', 'Initials': 'EE', 'LastName': 'Petersen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Janus', 'Initials': 'J', 'LastName': 'Engstrøm', 'Affiliation': 'Centre for Clinical Intervention Research, Rigshospitalet, Kobenhavn, Denmark.'}, {'ForeName': 'Janus C', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Torben Skov', 'Initials': 'TS', 'LastName': 'Hansen', 'Affiliation': 'Chromaviso, Aarhus, Denmark.'}, {'ForeName': 'Helle Østergaard', 'Initials': 'HØ', 'LastName': 'Madsen', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Hageman', 'Affiliation': 'Mental Health Services in the Capital Region of Denmark, Kobenhavn O, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Martiny', 'Affiliation': 'Psychiatric Centre Copenhagen, University Hospital Copenhagen, Copenhagen, Denmark klaus.martiny@regionh.dk.'}]",BMJ open,['10.1136/bmjopen-2019-032233']
411,32156580,An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale-A randomized controlled trial.,"STUDY DESIGN


A nonblinded randomized controlled trial.
INTRODUCTION


Occupation-based interventions are superior to physical exercise-based interventions in patients with activity limitations. However, only a few studies have examined the effect in patients with hand-related disorders. Patients recover heterogeneously, which could be due to personal factors, such as sense of coherence (SOC).
PURPOSE OF THE STUDY


To investigate the effectiveness of an occupation-based intervention for patients with hand-related disorders and whether SOC can give an indication of the expected effects.
METHODS


A total of 504 patients were stratified into three SOC groups and then randomized to either an occupation-based intervention, including physical exercises (OBI) or a physical exercise-based occupation-focused intervention. The primary outcome, functioning, was measured using the Disability of the Arm, Shoulder and Hand questionnaire. Primary endpoint was at three months. Patients were followed up for a year.
RESULTS


No significant difference was found in primary outcome analysis. Nevertheless, patients receiving OBI had a statistically significant and greater change in satisfaction with their occupational performance at one, two, and three months follow-up. Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.
CONCLUSIONS


OBI as delivered in this study was not superior to physical exercise-based occupation-focused intervention in this patient group. However, in taking a client-centered approach, we recommend that OBI be based on individual needs, given that patients had a statistically greater change in score regarding satisfaction with their occupational performance. It is evident that patients with a weaker SOC have a lower level of functioning. This knowledge should inform clinical practice.",2020,"Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.
","['patients with a weaker SOC', 'patients with hand-related disorders', '504 patients', 'patients with activity limitations', 'patients with hand-related disorders and whether SOC']","['occupation-based intervention, including physical exercises (OBI) or a physical exercise-based occupation-focused intervention', 'occupation-based intervention', 'Occupation-based interventions are superior to physical exercise-based interventions']","['worse functioning and lower health-related quality of life', 'Disability of the Arm, Shoulder and Hand questionnaire', 'satisfaction with their occupational performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",504.0,0.0820637,"Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.
","[{'ForeName': 'Alice Ørts', 'Initials': 'AØ', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Department of Orthopaedic Surgery, Odense University Hospital, Odense C, Denmark; Department of Rehabilitation, Odense University Hospital, Odense C, Denmark. Electronic address: alice.oerts@rsyd.dk.'}, {'ForeName': 'Hanne Kaae', 'Initials': 'HK', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Department of Rehabilitation, Odense University Hospital, Odense C, Denmark; Health Sciences Research Center, University College Lillebaelt, Odense M, Denmark.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Cederlund', 'Affiliation': 'Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; OPEN - Odense Patient data Explorative Network, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tromborg', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Department of Orthopaedic Surgery, Odense University Hospital, Odense C, Denmark.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.009']
412,30795705,Fluticasone furoate/vilanterol versus fluticasone propionate in patients with asthma and exercise-induced bronchoconstriction.,"Objective : To investigate whether once-daily (OD) fluticasone furoate (FF)/vilanterol (VI) provides greater long-term protection from postexercise fall in forced expiratory volume in 1 s (FEV 1 ) than twice-daily (BD) fluticasone propionate (FP) in patients with asthma and exercise-induced bronchoconstriction.  Methods : A randomized, double-blind, crossover study was conducted in patients (aged 12-50 years) on low-/mid-dose maintenance inhaled corticosteroid. Following a 4-week run-in period (FP 250 µg BD), patients with a ≥ 20% decrease in postexercise FEV 1  received FF/VI 100/25 µg OD or FP 250 µg BD for 2 weeks. Exercise challenges were carried out 23 h after the first dose of study medication, and 12 and 23 h after evening clinic dose at the end of the 2-week treatment period. After a 2-week washout period (FP 250 µg), patients crossed over treatments, with procedures and tests repeated. The primary endpoint was mean maximal percentage decrease from pre-exercise FEV 1  following exercise challenge 12-h postevening dose on Day 14.  Results:  The mean maximal percentage decrease from pre-exercise FEV 1  after the 12-h exercise challenge (Day 14) was 15.02% with FF/VI, and 16.71% with FP (difference, -1.69; 95% confidence interval, -3.76 to 0.39;  p =  0.109). After the 23-h exercise challenge (Day 14), respective mean maximal decreases were 11.90% and 14.05% (difference, -2.15; 95% confidence interval, -4.31 to 0.01).  Conclusion:  The study failed to show a difference between FF/VI and FP at providing long-term protection from exercise-induced bronchoconstriction.",2020,"After the 23-h exercise challenge (Day 14), respective mean maximal decreases were 11.90% and 14.05% (difference, -2.15; 95% confidence interval, -4.31 to 0.01).
","['patients (aged 12-50 years) on', 'patients with asthma and exercise-induced bronchoconstriction']","['low-/mid-dose maintenance inhaled corticosteroid', 'Fluticasone furoate/vilanterol versus fluticasone propionate', 'daily (OD) fluticasone furoate (FF)/vilanterol (VI', 'twice-daily (BD) fluticasone propionate (FP']","['mean maximal percentage decrease from pre-exercise FEV 1  following exercise challenge 12-h postevening dose on Day 14', 'postexercise FEV', 'respective mean maximal decreases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",,0.268289,"After the 23-h exercise challenge (Day 14), respective mean maximal decreases were 11.90% and 14.05% (difference, -2.15; 95% confidence interval, -4.31 to 0.01).
","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Weiler', 'Affiliation': 'CompleWare, Iowa City, IA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pearlman', 'Affiliation': 'Colorado Allergy and Asthma Centers PC, Denver, CO, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Jacques', 'Affiliation': 'GSK, London, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Nunn', 'Affiliation': 'GSK, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Forth', 'Affiliation': 'GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'GSK, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dunn', 'Affiliation': 'North Carolina Clinical Research, Raleigh, NC, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': ""O'Byrne"", 'Affiliation': 'Firestone Institute for Respiratory Health, Hamilton, ON, Canada.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2019.1579344']
413,32157182,Effect of corneal stromal pocket irrigation in small-incision lenticule extraction.,"OBJECTIVES


To investigate the effect of corneal stromal pocket irrigation after small-incision lenticule extraction (SMILE) on visual acuity, intraocular pressure (IOP), corneal parameters and complications after surgery.
METHODS


A total of 242 eyes of 121 patients undergoing SMILE were enrolled in this prospective controlled study, and it was designed for one eye to randomly undergo SMILE with balanced salt solution irrigation of the corneal stromal pocket, while the other eye was not. The uncorrected distance visual acuity (UDVA) and slit lamp examination were recorded at 1 hour, 1 day, 1 week, and 1 month. Postoperative corneal density, corneal biomechanical, corneal endothelial cell number, and anterior OCT images were compared at 1 day, 1 week, and 1 month.
RESULTS


Compared with the nonirrigation group, the irrigation group showed significantly higher UDVA at 1 day postoperatively (P < 0.05), but there was no significant difference during the rest of the postoperative period (1 hour, 1 week, and 1 month). In addition, no significant differences were found in IOP, corneal density, corneal biomechanics, corneal endothelial cells, and corneal morphology. No visual decline or severe postoperative complications were found in the patients in this study.
CONCLUSIONS


Interlamellar irrigation did not affect IOP, corneal parameters, morphology, complications, or UDVA at 1 hour, 1 week, and 1 month after the operation, but it may promote UDVA 1 day after the operation.",2020,"Compared with the nonirrigation group, the irrigation group showed significantly higher UDVA at 1 day postoperatively (P < 0.05), but there was no significant difference during the rest of the postoperative period (1 hour, 1 week, and 1 month).","['small-incision lenticule extraction', 'A total of 242 eyes of 121 patients undergoing SMILE']","['SMILE with balanced salt solution irrigation', 'corneal stromal pocket irrigation', 'corneal stromal pocket irrigation after small-incision lenticule extraction (SMILE']","['visual decline or severe postoperative complications', 'uncorrected distance visual acuity (UDVA) and slit lamp examination', 'UDVA', 'IOP, corneal density, corneal biomechanics, corneal endothelial cells, and corneal morphology', 'IOP, corneal parameters, morphology, complications, or UDVA', 'visual acuity, intraocular pressure (IOP), corneal parameters and complications', 'Postoperative corneal density, corneal biomechanical, corneal endothelial cell number, and anterior OCT images']","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}]","[{'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0419360', 'cui_str': 'Slit Lamp Examination'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]",121.0,0.0407476,"Compared with the nonirrigation group, the irrigation group showed significantly higher UDVA at 1 day postoperatively (P < 0.05), but there was no significant difference during the rest of the postoperative period (1 hour, 1 week, and 1 month).","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Hainan Eye Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou, 571152, Hainan Province, China.'}, {'ForeName': 'Bo-Wen', 'Initials': 'BW', 'LastName': 'Ouyang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China.'}, {'ForeName': 'Zhenduo', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Hainan Eye Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou, 571152, Hainan Province, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Zhong', 'Affiliation': 'Hainan Eye Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou, 571152, Hainan Province, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Hainan Eye Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University, Haikou, 571152, Hainan Province, China.'}, {'ForeName': 'Xingwu', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, 510060, China. zhongxwu@mail.sysu.edu.cn.'}]","Eye (London, England)",['10.1038/s41433-020-0840-1']
414,32157250,High-intensity interval training produces a significant improvement in fitness in less than 31 days before surgery for urological cancer: a randomised control trial.,"OBJECTIVES


To assess the efficacy of high-intensity interval training (HIIT) for improving cardiorespiratory fitness (CRF) in patients awaiting resection for urological malignancy within four weeks.
SUBJECTS/PATIENTS AND METHODS


A randomised control trial of consecutive patients aged (>65 years) scheduled for major urological surgery in a large secondary referral centre in a UK hospital. The primary outcome is change in anaerobic threshold (VO 2AT ) following HIIT vs. standard care.
RESULTS


Forty patients were recruited (mean age 72 years, male (39): female (1)) with 34 completing the protocol. Intention to treat analysis showed significant improvements in anaerobic threshold (VO 2AT ; mean difference (MD) 2.26 ml/kg/min (95% CI 1.25-3.26)) following HIIT. Blood pressure (BP) also significantly reduced in following: HIIT (SBP: -8.2 mmHg (95% CI -16.09 to -0.29) and DBP: -6.47 mmHg (95% CI -12.56 to -0.38)). No reportable adverse safety events occurred during HIIT and all participants achieved >85% predicted maximum heart rate during sessions, with protocol adherence of 84%.
CONCLUSIONS


HIIT can improve CRF and cardiovascular health, representing clinically meaningful and achievable pre-operative improvements. Larger randomised trials are required to investigate the efficacy of prehabilitation HIIT upon different cancer types, post-operative complications, socio-economic impact and long-term survival.",2020,"No reportable adverse safety events occurred during HIIT and all participants achieved >85% predicted maximum heart rate during sessions, with protocol adherence of 84%.
","['consecutive patients aged (>65 years) scheduled for major urological surgery in a large secondary referral centre in a UK hospital', 'patients awaiting resection for urological malignancy within four weeks', 'Forty patients were recruited (mean age 72 years, male (39): female (1)) with 34 completing the protocol', 'urological cancer']","['High-intensity interval training', 'high-intensity interval training (HIIT']","['DBP', 'change in anaerobic threshold (VO 2AT ', 'anaerobic threshold', 'CRF and cardiovascular health', 'adverse safety events', 'maximum heart rate', 'Blood pressure (BP', 'cardiorespiratory fitness (CRF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0751571', 'cui_str': 'Cancer of Urinary Tract'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",40.0,0.373067,"No reportable adverse safety events occurred during HIIT and all participants achieved >85% predicted maximum heart rate during sessions, with protocol adherence of 84%.
","[{'ForeName': 'J E M', 'Initials': 'JEM', 'LastName': 'Blackwell', 'Affiliation': 'University of Nottingham, Nottingham, UK. james.blackwell@nhs.net.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Doleman', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Boereboom', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Atherton', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Williams', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Lund', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0219-1']
415,31521683,The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation.,"OBJECTIVES


This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling.
BACKGROUND


Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis.
METHODS


In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis.
RESULTS


Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: -11.7 to -2.5] vs. an increase of 3.3 ml/beat [95% CI: -6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: -18.5 to -2.4] vs. an increase of 6.5 ml [95% CI: -5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: -12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: -1.42 to 13.6]; p = 0.04).
CONCLUSIONS


The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830).",2019,The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy.,"['symptomatic patients with functional mitral regurgitation receiving optimal medical therapy', '120 patients receiving optimal heart failure medical therapy', 'Patients (69.8 ± 9.5 years of age', 'Annuloplasty in Functional Mitral Regurgitation']","['coronary sinus-based mitral annular reduction approach for FMR or sham', 'Carillon device', 'Percutaneous Mitral']","['mitral regurgitant volume and left ventricular volumes', 'mitral regurgitant volume', 'left ventricular volumes']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation (disorder)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0190165', 'cui_str': 'Reconstruction of annulus of cardiac valve (procedure)'}]","[{'cui': 'C0456944', 'cui_str': 'Coronary Sinus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",120.0,0.176771,The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy.,"[{'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom. Electronic address: k.k.witte@leeds.ac.uk.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Lipiecki', 'Affiliation': 'Clinique Pôle Sanioyté République, Clermont Ferrand, France.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Siminiak', 'Affiliation': 'Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Meredith', 'Affiliation': 'Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Malkin', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Goldberg', 'Affiliation': 'Tyler Heart Institute at Community Hospital of the Monterey Peninsula, Monterey, California; Cardiac Dimensions, Kirkland, Washington.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Stark', 'Affiliation': 'Cardiac Dimensions, Kirkland, Washington.'}, {'ForeName': 'Ralph Stephan', 'Initials': 'RS', 'LastName': 'von Bardeleben', 'Affiliation': 'Department of Cardiology, University Medical Centre Mainz, Mainz, Germany.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Jaber', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Celermajer', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Sievert', 'Affiliation': 'CardioVascular Center Sankt Katherinen, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.06.011']
416,31924247,Evaluation of the Teaching Recovery Techniques community-based intervention for unaccompanied refugee youth experiencing post-traumatic stress symptoms (Swedish UnaccomPanied yOuth Refugee Trial; SUPpORT): study protocol for a randomised controlled trial.,"BACKGROUND


In 2015, 162,877 persons sought asylum in Sweden, 35,369 of whom were unaccompanied refugee minors (URMs). Refugee children, especially URMs, have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue years after resettlement. The Swedish UnaccomPanied yOuth Refugee Trial (SUPpORT) aims to evaluate a community-based intervention, called Teaching Recovery Techniques (TRT), for refugee youth experiencing PTSD symptoms.
METHODS/DESIGN


A randomised controlled trial will be conducted in which participants will be randomly allocated to one of two possible arms: the intervention arm (n = 109) will be offered the TRT programme, and the waitlist-control arm (n = 109) will receive services as usual, followed by the TRT programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; about 8 weeks after randomisation) and follow-up (T3; about 20 weeks after randomisation).
DISCUSSION


This study will provide knowledge about the effect and efficiency of a group intervention for URMs reporting symptoms of PTSD in Sweden.
TRIAL REGISTRATION


ISRCTN, ISRCTN47820795. Prospectively registered on 20 December 2018.",2020,"Refugee children, especially URMs, have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue years after resettlement.","['URMs reporting symptoms of PTSD in Sweden', 'Prospectively registered on 20 December 2018', 'unaccompanied refugee youth experiencing post-traumatic stress symptoms (Swedish UnaccomPanied yOuth', '162,877 persons sought asylum in Sweden, 35,369 of whom were unaccompanied refugee minors (URMs']","['TRT programme, and the waitlist-control arm (n\u2009=\u2009109) will receive services as usual, followed by the TRT programme', 'community-based intervention, called Teaching Recovery Techniques (TRT', 'Teaching Recovery Techniques community-based intervention']",[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",[],,0.20262,"Refugee children, especially URMs, have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue years after resettlement.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sarkadi', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Warner', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden. Georgina.Warner@pubcare.uu.se.'}, {'ForeName': 'Raziye', 'Initials': 'R', 'LastName': 'Salari', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Fängström', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Durbeej', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lampa', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Zaruhi', 'Initials': 'Z', 'LastName': 'Baghdasaryan', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Fatumo', 'Initials': 'F', 'LastName': 'Osman', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gupta Löfving', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Perez Aronsson', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Feldman', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Sampaio', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ssegonja', 'Affiliation': 'Child Health and Parenting (CHAP), Department of Public Health and Caring Sciences, Uppsala University, Box 564, BMC, Husargatan 3, 751 22, Uppsala, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Calam', 'Affiliation': 'Division of Clinical Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjärtå', 'Affiliation': 'Department of Psychology, Mid-Sweden University, Östersund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Leiler', 'Affiliation': 'Department of Psychology, Mid-Sweden University, Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Rondung', 'Affiliation': 'Department of Psychology, Mid-Sweden University, Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Wasteson', 'Affiliation': 'Department of Psychology, Mid-Sweden University, Östersund, Sweden.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Oppedal', 'Affiliation': 'Division of Mental Health, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Brooks', 'Initials': 'B', 'LastName': 'Keeshin', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, Utah, USA.'}]",Trials,['10.1186/s13063-019-3814-5']
417,31129065,"Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial.","BACKGROUND


Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy.
METHODS


RESTART was a prospective, randomised, open-label, blinded-endpoint, parallel-group trial at 122 hospitals in the UK that assessed whether starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. For this prespecified subgroup analysis, consultant neuroradiologists masked to treatment allocation reviewed brain CT or MRI scans performed before randomisation to confirm participant eligibility and rate features of the intracerebral haemorrhage and surrounding brain. We followed participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere). For this report, we analysed eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI. The trial is registered with the ISRCTN registry, number ISRCTN71907627.
FINDINGS


Between May 22, 2013, and May 31, 2018, 537 participants were enrolled, of whom 525 (98%) had intracerebral haemorrhage: 507 (97%) were diagnosed on CT (252 assigned to start antiplatelet therapy and 255 assigned to avoid antiplatelet therapy, of whom one withdrew and was not analysed) and 254 (48%) underwent the required brain MRI protocol (122 in the start antiplatelet therapy group and 132 in the avoid antiplatelet therapy group). There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence (0 or 1) (adjusted hazard ratio [HR] 0·30 [95% CI 0·08-1·13] vs 0·77 [0·13-4·61]; p interaction =0·41), cerebral microbleed number 0-1 versus 2-4 versus 5 or more (HR 0·77 [0·13-4·62] vs 0·32 [0·03-3·66] vs 0·33 [0·07-1·60]; p interaction =0·75), or cerebral microbleed strictly lobar versus other location (HR 0·52 [0·004-6·79] vs 0·37 [0·09-1·28]; p interaction =0·85). There was no evidence of heterogeneity in the effects of antiplatelet therapy in any exploratory subgroup analyses (all p interaction >0·05).
INTERPRETATION


Our findings exclude all but a very modest harmful effect of antiplatelet therapy on recurrent intracerebral haemorrhage in the presence of cerebral microbleeds. Further randomised trials are needed to replicate these findings and investigate them with greater precision.
FUNDING


British Heart Foundation.",2019,There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence,"['Between May 22, 2013, and May 31, 2018, 537 participants were enrolled, of whom 525 (98%) had intracerebral haemorrhage: 507 (97%) were diagnosed on CT (252 assigned to start antiplatelet therapy and 255 assigned to avoid antiplatelet therapy, of whom one withdrew and was not analysed) and 254 (48%) underwent the required', 'eligible participants with intracerebral haemorrhage according to their treatment allocation in primary subgroup analyses of cerebral microbleeds on MRI and in exploratory subgroup analyses of other features on CT or MRI', 'intracerebral haemorrhage and cerebral small vessel diseases', '0·13-4·62', 'participants for primary (recurrent symptomatic intracerebral haemorrhage) and secondary (ischaemic stroke) outcomes for up to 5 years (reported elsewhere', '0·004-6·79']","['antiplatelet therapy', 'cerebral microbleed strictly lobar versus other location (HR 0·52', 'brain MRI protocol']","['recurrent intracerebral haemorrhage', 'stroke risk', 'risk of recurrent symptomatic intracerebral haemorrhage']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2733158', 'cui_str': 'Cerebral Microangiopathies'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",537.0,0.211384,There were no clinically or statistically significant hazards of antiplatelet therapy on recurrent intracerebral haemorrhage in primary subgroup analyses of cerebral microbleed presence (2 or more) versus absence,"[{'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK. Electronic address: rustam.al-shahi@ed.ac.uk.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Minks', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Dipayan', 'Initials': 'D', 'LastName': 'Mitra', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK; Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Rodrigues', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Johann C', 'Initials': 'JC', 'LastName': 'du Plessis', 'Affiliation': 'Department of Clinical Neurosciences, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'Yogish', 'Initials': 'Y', 'LastName': 'Joshi', 'Affiliation': ""Department of Radiology, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Peter A G', 'Initials': 'PAG', 'LastName': 'Sandercock', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Division of Clinical Neurosciences, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Stephen', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cathie L M', 'Initials': 'CLM', 'LastName': 'Sudlow', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Werring', 'Affiliation': 'Stroke Research Group, Department of Brain Repair and Rehabilitation, University College London Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Whiteley', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK; UK Dementia Research Institute at the University of Edinburgh, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'White', 'Affiliation': 'Department of Neuroradiology, Newcastle-upon-Tyne Hospitals NHS Trust, Newcastle-upon-Tyne, UK; Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30184-X']
418,31937351,Bayesian group sequential designs for phase III emergency medicine trials: a case study using the PARAMEDIC2 trial.,"BACKGROUND


Phase III trials often require large sample sizes, leading to high costs and delays in clinical decision-making. Group sequential designs can improve trial efficiency by allowing for early stopping for efficacy and/or futility and thus may decrease the sample size, trial duration and associated costs. Bayesian approaches may offer additional benefits by incorporating previous information into the analyses and using decision criteria that are more practically relevant than those used in frequentist approaches. Frequentist group sequential designs have often been used for phase III studies, but the use of Bayesian group sequential designs is less common. The aim of this work was to explore how Bayesian group sequential designs could be constructed for phase III trials conducted in emergency medicine.
METHODS


The PARAMEDIC2 trial was a phase III randomised controlled trial that compared the use of adrenaline to placebo in out-of-hospital cardiac arrest patients on 30-day survival rates. It used a frequentist group sequential design to allow early stopping for efficacy or harm. We constructed several alternative Bayesian group sequential designs and studied their operating characteristics via simulation. We then virtually re-executed the trial by applying the Bayesian designs to the PARAMEDIC2 data to demonstrate what might have happened if these designs had been used in practice.
RESULTS


We produced three alternative Bayesian group sequential designs, each of which had greater than 90% power to detect the target treatment effect. A Bayesian design which performed interim analyses every 500 patients recruited produced the lowest average sample size. Using the alternative designs, the PARAMEDIC2 trial could have declared adrenaline superior for 30-day survival with approximately 1500 fewer patients.
CONCLUSIONS


Using the PARAMEDIC2 trial as a case study, we demonstrated how Bayesian group sequential designs can be constructed for phase III emergency medicine trials. The Bayesian framework enabled us to obtain efficient designs using decision criteria based on the probability of benefit or harm. It also enabled us to incorporate information from previous studies on the treatment effect via the prior distributions. We recommend the wider use of Bayesian approaches in phase III clinical trials.
TRIAL REGISTRATION


PARAMEDIC2 Trial registration ISRCTN, ISRCTN73485024. Registered 13 March 2014, http://www.isrctn.com/ISRCTN73485024.",2020,"Group sequential designs can improve trial efficiency by allowing for early stopping for efficacy and/or futility and thus may decrease the sample size, trial duration and associated costs.",['500 patients recruited produced the lowest average sample size'],['adrenaline to placebo'],"['30-day survival', '30-day survival rates']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0820078,"Group sequential designs can improve trial efficiency by allowing for early stopping for efficacy and/or futility and thus may decrease the sample size, trial duration and associated costs.","[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Ryan', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK. E.G.Ryan@bham.ac.uk.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Statistics and Epidemiology, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.'}]",Trials,['10.1186/s13063-019-4024-x']
419,31937347,"Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study.","BACKGROUND


Traumatic brain injury is a leading cause of death and disability worldwide. The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.
METHODS/DESIGN


The NOSTRA phase III trial (Ronopterin in traumatic brain injury) is a multi-centre, prospective, randomised, double-blinded, placebo-controlled, phase III trial in Europe. It aims at determining whether the administration of Ronopterin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at 6 months after injury. The trial is designed to recruit patients between 18 and 60 years of age with moderate or severe traumatic brain injury (Glasgow Coma Scale score ≥ 3) and requiring insertion of an intracranial pressure probe. Trial patients will receive a 48-h intravenous infusion of either Ronopterin or placebo starting at the earliest 6 h and at the latest 18 h after injury. The primary outcome will be the extended Glasgow Outcome Score (eGOS) at 6 months. Secondary outcomes will include the Quality of Life Index (QOLIBRI) at 6 months after the injury and the eGOS at 3 months after the injury. Additionally, effects on mortality, intracranial pressure and cerebral perfusion pressure are evaluated.
DISCUSSION


The trial aims to provide evidence on the efficacy and safety of Ronopterin in patients with traumatic brain injury.
TRIAL REGISTRATION


EudraCT, 2013-003368-29. Registered on 9 March 2016. ClinicalTrials.gov, NCT02794168. Registered on 8 June 2016. Protocol version 14.0 from 05 November 2018.",2020,"The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.
","['Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial', 'patients between 18 and 60\u2009years of age with moderate or severe traumatic brain injury (Glasgow Coma Scale score ≥\u20093) and requiring insertion of an intracranial pressure probe', 'patients with traumatic brain injury', 'patients with moderate or severe traumatic brain injury at 6 months after injury']","['placebo', 'Ronopterin', 'Ronopterin or placebo', 'Ronopterin (VAS203']","['mortality, intracranial pressure and cerebral perfusion pressure', 'Quality of Life Index (QOLIBRI', 'extended Glasgow Outcome Score (eGOS', 'neurological outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4045572', 'cui_str': 'VAS203'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0021880', 'cui_str': 'Subarachnoid Pressure'}, {'cui': 'C0428713', 'cui_str': 'Cerebral Perfusion Pressure'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.746331,"The nitric oxide synthase inhibitor Ronopterin was shown to improve clinical outcome by enhancing neuroprotection in a phase IIa trial.
","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tegtmeier', 'Affiliation': 'vasopharm GmbH, Würzburg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Schinzel', 'Affiliation': 'vasopharm GmbH, Würzburg, Germany. schinzel@vasopharm.de.'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Beer', 'Affiliation': 'Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Bulters', 'Affiliation': 'Wessex Neurological Centre University Hospital, Southampton, UK.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'LeFrant', 'Affiliation': 'Hopital Universitaire Caremeau , Nimes, France.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Sahuquillo', 'Affiliation': ""Vall d'Hebron University Hospital , Barcelona, Spain.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Unterberg', 'Affiliation': 'Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Andrews', 'Affiliation': 'Western General Hospital Lothian University , Edinburgh, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Belli', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ibanez', 'Affiliation': 'Espases University Hospital , Palma de Mallorca, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Lagares', 'Affiliation': 'Hospital Universitario 12 de Octubre , Madrid, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mokry', 'Affiliation': 'LKH - Universitätsklinikum Graz, Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Willschke', 'Affiliation': 'Medizinische Universität Wien, Wien, Austria.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Flüh', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Schmutzhard', 'Affiliation': 'Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3965-4']
420,31924249,The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.,"BACKGROUND


Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes.
METHODS


This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability.
DISCUSSION


Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.",2020,Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings.,"['1440 adult patients with type 2 diabetes', 'Twenty primary care practices']","['standardized or patient-driven SMAs', 'SMAs']","['diabetes distress', 'autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability']","[{'cui': 'C4517576', 'cui_str': 'One thousand four hundred and forty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C1831580', 'cui_str': 'Superficial Musculo-Aponeurotic System'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",1440.0,0.101284,Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings.,"[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA. bethany.kwan@cuanschutz.edu.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Case Western Reserve University, 10900 Euclid Ave, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gritz', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Jodi Summers', 'Initials': 'JS', 'LastName': 'Holtrop', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Don E', 'Initials': 'DE', 'LastName': 'Nease', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ritchie', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nederveld', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gurfinkel', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}, {'ForeName': 'Jeanette A', 'Initials': 'JA', 'LastName': 'Waxmonsky', 'Affiliation': 'University of Colorado School of Medicine, 13199 E Montview Blvd Ste 210, Aurora, CO, 80045, USA.'}]",Trials,['10.1186/s13063-019-3938-7']
421,32146720,Adjunctive effects of laser therapy on somatosensory function and vasomotor regulation of periodontal tissues in patients with periodontitis: A randomized controlled clinical trial.,"BACKGROUND


The purpose of this prospective study was to compare the changes in periodontal somatosensory function and microcirculation in patients with periodontitis following initial treatment with scaling and root planing (SRP) with or without adjuvant laser therapy.
METHODS


Twenty-four patients suffering from periodontitis were recruited and randomly allocated into a split-mouth design to either SRP combined laser therapy side (test side) or SRP only side (control side). All treatments were performed by the same investigator at a single visit. Laser Doppler Flowmetry (LDF) and Quantitative Sensory Testing (QST) were performed at baseline (W0), 1 week (1W), 2 weeks (2W), and 4 weeks (4W) after treatment on both sides of the attached gingiva of the maxillary lateral incisor. Clinical examination including probing depth (PD) and bleeding on probing (BOP) was performed at W0, 2W, and 4W on both sides. Data were analyzed with two-way analysis of variance.
RESULTS


PD and BOP significantly improved after treatment (P <0.001). LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792). Significantly less sensitivity was observed for all QST parameters (P <0.030) except for warmth detection after treatment.
CONCLUSION


Adjunctive use of laser therapy did not provide any significant clinical advantage or additional effects on the recovery of periodontal somatosensory function or gingival microcirculation in the present study.",2020,"The LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792).","['patients with periodontitis', 'patients with periodontitis following initial treatment with scaling and root planing (SRP) with or without adjuvant laser therapy', 'Twenty-four patients suffering from periodontitis']","['laser therapy', 'SRP combined laser therapy side (test side) or SRP only side (control side']","['somatosensory function and vasomotor regulation of periodontal tissues', 'periodontal somatosensory function or gingival microcirculation', 'LDF values', 'Laser Doppler Flowmetry (LDF) and Quantitative Sensory Testing (QST', 'PPD and BOP', 'sensitivity', 'pocket probing depth (PPD) and bleeding on probing (BOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",24.0,0.0325481,"The LDF values were significantly decreased on both sides at all follow-up time points (P <0.001), temperature was increased only on the test side (P = 0.017) whereas there was no significant change on the control side (P = 0.792).","[{'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Gou', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ruyi', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Jiangsu Key Laboratory of Oral Disease, Affiliated Hospital of Stomatology, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kelun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Journal of periodontology,['10.1002/JPER.19-0562']
422,32054300,Process evaluation of complex cardiovascular interventions: How to interpret the results of my trial?,"Complex interventions of varying degrees of complexity are commonly used and evaluated in cardiovascular nursing and allied professions. Such interventions are increasingly tested using randomized trial designs. However, process evaluations are seldom used to better understand the results of these trials. Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention. As such, this method can illuminate important mechanisms and clarify variation in results. In this article, process evaluation is described according to the Medical Research Council guidance and its use exemplified through a randomized controlled trial evaluating the effectiveness of a transition program for adolescents with chronic conditions.",2020,"Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention.",['adolescents with chronic conditions'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],[],,0.0706835,"Process evaluation aims to understand how complex interventions create change by evaluating implementation, mechanisms of impact, and the surrounding context when delivering an intervention.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Saarijärvi', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallin', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Ewa-Lena', 'Initials': 'EL', 'LastName': 'Bratt', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515120906561']
423,31750786,Targeted Treatment Protocol in Patellofemoral Pain: Does Treatment Designed According to Subgroups Improve Clinical Outcomes in Patients Unresponsive to Multimodal Treatment?,"BACKGROUND


Targeted intervention for subgroups is a promising approach for the management of patellofemoral pain.
HYPOTHESIS


Treatment designed according to subgroups will improve clinical outcomes in patients unresponsive to multimodal treatment.
STUDY DESIGN


Prospective crossover intervention.
LEVEL OF EVIDENCE


Level 3.
METHODS


Patients with patellofemoral pain (PFP; n = 61; mean age, 27 ± 9 years) were enrolled. Patients with PFP received standard multimodal treatment 3 times a week for 6 weeks. Patients not responding to multimodal treatment were then classified into 1 of 3 subgroups (strong, weak and tight, and weak and pronated foot) using 6 simple clinical tests. They were subsequently administered 6 further weeks of targeted intervention, designed according to subgroup characteristics. Visual analog scale (VAS), perception of recovery scale (PRS), 5-Level European Quality 5 Dimensions (EQ-5D-5L), and self-reported version of the Leeds Assessment of Neuropathic Symptoms and Signs scale (S-LANSS) were used to assess pain, knee function, and quality of life before and after the interventions.
RESULTS


In total, 34% (n = 21) of patients demonstrated recovery after multimodal treatment. However, over 70% (n = 29/40) of nonresponders demonstrated recovery after targeted treatment. The VAS, PRS, S-LANSS, and EQ-5D-5L scores improved significantly after targeted intervention compared with after multimodal treatment ( P  < 0.001). The VAS score at rest was significantly lower in the ""weak and pronated foot"" and the ""weak and tight"" subgroups ( P  = 0.011 and  P  = 0.008, respectively). Posttreatment pain intensity on activity was significantly lower in the ""strong"" subgroup ( P  = 0.006).
CONCLUSION


Targeted treatment designed according to subgroup characteristics improves clinical outcomes in patients unresponsive to multimodal treatment.
CLINICAL RELEVANCE


Targeted intervention could be easily implemented after 6 simple clinical assessment tests to subgroup patients into 1 of 3 subgroups (strong, weak and tight, and weak and pronated foot). Targeted interventions applied according to the characteristics of these subgroups have more beneficial treatment effects than a current multimodal treatment program.",2020,"Posttreatment pain intensity on activity was significantly lower in the ""strong"" subgroup ( P  = 0.006).
","['Patellofemoral Pain', 'subgroup patients into 1 of 3 subgroups (strong, weak and tight, and weak and pronated foot', 'Patients with patellofemoral pain (PFP; n = 61; mean age, 27 ± 9 years) were enrolled', 'patients unresponsive to multimodal treatment']",[],"['VAS, PRS, S-LANSS, and EQ-5D-5L scores', 'pain, knee function, and quality of life', 'Visual analog scale (VAS), perception of recovery scale (PRS), 5-Level European Quality 5 Dimensions (EQ-5D-5L), and self-reported version of the Leeds Assessment of Neuropathic Symptoms and Signs scale (S-LANSS', 'VAS score at rest', 'Posttreatment pain intensity on activity']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0222045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",6.0,0.0296229,"Posttreatment pain intensity on activity was significantly lower in the ""strong"" subgroup ( P  = 0.006).
","[{'ForeName': 'Hayri Baran', 'Initials': 'HB', 'LastName': 'Yosmaoğlu', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Baskent University, Ankara, Turkey.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Selfe', 'Affiliation': 'Department of Health Professions, Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Sonmezer', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Baskent University, Ankara, Turkey.'}, {'ForeName': 'İlknur Ezgi', 'Initials': 'İE', 'LastName': 'Sahin', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Senay Çerezci', 'Initials': 'SÇ', 'LastName': 'Duygu', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Manolya', 'Initials': 'M', 'LastName': 'Acar Ozkoslu', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Science, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Richards', 'Affiliation': 'Allied Health Research Unit, School of Health Sciences, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Janssen', 'Affiliation': 'IMC University of Applied Sciences, Krems, Austria.'}]",Sports health,['10.1177/1941738119883272']
424,30768397,Changes in General and Specific Psychopathology Factors Over a Psychosocial Intervention.,"OBJECTIVE


Recent research suggests that comorbidity in child and adolescent psychiatric symptoms can be summarized by a single latent dimension known as the p factor and more specific factors summarizing clusters of symptoms. This study investigated within- and between-person changes in general and specific psychopathology factors over a psychosocial intervention.
METHOD


A secondary analysis was conducted of the Systemic Therapy for At-Risk Teens study, a pragmatic randomized controlled trial that compared the effects of multisystemic therapy with those of management as usual for decreasing antisocial behavior in 684 adolescents (82% boys; 11-18 years old at baseline) over an 18-month period. The general p factor and specific antisocial, attention, anxiety, and mood factors were estimated from a symptom-level analysis of a set of narrowband symptom scales measured repeatedly during the study. General and specific psychopathology factors were assessed for reliability, validity, and within- and between-person change using a parallel process multilevel growth model.
RESULTS


A revised bi-factor model that included a general p factor and specific anxiety, mood, antisocial, and attention factors with cross-loadings fit the data best. Although the factor structure was multidimensional, the p factor accounted for most of the variance in total scores. The p factor, anxiety, and antisocial factors predicted within-person variation in external outcomes. Furthermore, the p factor and antisocial factors showed within-person declines, whereas anxiety showed within-person increases, over time. Despite individual variation in baseline factor scores, adolescents showed similar rates of change.
CONCLUSION


The bi-factor model is useful for teasing apart general and specific therapeutic changes that are conflated in standard analyses of symptom scores.
CLINICAL TRIAL REGISTRATION INFORMATION


START (Systemic Therapy for At Risk Teens): A National Randomised Controlled Trial to Evaluate Multisystemic Therapy in the UK Context; http://www.isrctn.com; ISRCTN77132214.",2019,"Despite individual variation in baseline factor scores, adolescents showed similar rates of change.
","['At Risk Teens', '684 adolescents (82% boys; 11-18 years old at baseline) over an 18-month period']",['multisystemic therapy'],"['general p factor and specific antisocial, attention, anxiety, and mood factors']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy (regime/therapy)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",684.0,0.113647,"Despite individual variation in baseline factor scores, adolescents showed similar rates of change.
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Constantinou', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK. Electronic address: matthew.constantinou.13@ucl.ac.uk.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Eisler', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK; South London and Maudsley NHS Foundation Trust, University College London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': 'University of Prince Edward Island, Charlottetown, Canada.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Kraam', 'Affiliation': 'University of Leeds and Leeds Community Healthcare NHS Trust, Leeds, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simes', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ellison', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allison', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.11.011']
425,32151349,Intragastric balloon placement in the treatment of overweight and obesity: Experience at a Mexican referral center.,"INTRODUCTION AND AIM


Intragastric balloon therapy is a temporary, minimally invasive method for inducing weight loss. Any balloon with a volume of 400mL induces satiety and delayed gastric emptying. The aim of the present study was to demonstrate its safety and efficacy.
MATERIALS AND METHODS


We analyzed the safety and effectiveness of balloon placement in relation to weight loss in 128patients. Subgroups were compared through the Student's t test, ANOVA test, and the chi-square test, depending on the type of variable and the number of groups evaluated. Statistical significance was set at a P≤.05 to evaluate weight loss.
RESULTS


Mean weight loss after balloon therapy was 10.7kg, with only 2 cases of complications due to oral feeding intolerance. Mean length of time with the balloon was 8months. There were no complications after 6months, but no further weight loss either (P=.540). Final weight loss versus initial weight loss was significant (P=.000). There was greater weight loss in the group that attended the bimonthly control appointments than in the group that did not: 12.7kg vs. 7.26kg (P=.000).
CONCLUSIONS


The rates of the adverse events of intolerance and complications were very low in our study, compared with results in the literature: 1.6% vs. 4.7% and 0% vs. 3%, respectively. Intragastric balloon placement had better results when the patients attended the control appointments. Intragastric balloon therapy is a safe and efficacious method for reducing weight in patients with overweight and obesity.",2020,"There were no complications after 6months, but no further weight loss either (P=.540).","['patients with overweight and obesity', 'overweight and obesity: Experience at a Mexican referral center', '128patients']","['balloon placement', 'Intragastric balloon placement', 'Intragastric balloon therapy']","['Mean weight loss', 'weight loss', 'Final weight loss versus initial weight loss', 'Mean length of time', 'satiety and delayed gastric emptying', 'safety and efficacy', 'rates of the adverse events of intolerance and complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442113', 'cui_str': 'Intragastric (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0261697,"There were no complications after 6months, but no further weight loss either (P=.540).","[{'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Hernández-Lara', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, Estados Unidos. Electronic address: ariostoster@hotmail.com.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Almazán-Urbina', 'Affiliation': 'Departamento de Endoscopia, Hospital Central Militar, Ciudad de México, México.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Santiago-Torres', 'Affiliation': 'Jefatura de servicios auxiliares diagnósticos, Hospital Central Militar, Ciudad de México, México.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rangel-Cruz', 'Affiliation': 'Departamento de Endoscopia, Hospital Central Militar, Ciudad de México, México.'}]",Revista de gastroenterologia de Mexico,['10.1016/j.rgmx.2019.10.007']
426,31727662,Effectiveness of different recruitment strategies in an RCT of a surgical device: experience from the Endobarrier trial.,"Recruiting participants into clinical trials is notoriously difficult and poses the greatest challenge when planning any investigative study. Poor recruitment may not only have financial ramifications owing to increased time and resources being spent but could adversely influence the clinical impact of a study if it becomes underpowered. Herein, we present our own experience of recruiting into a nationally funded, multicentre, randomised controlled trial (RCT) of the Endobarrier versus standard medical therapy in obese patients with type 2diabetes. Despite these both being highly prevalent conditions, there were considerable barriers to the effectiveness of different recruitment strategies across each study site. Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered. From this experience, we propose where appropriate the early engagement and investment in media campaigns to enhance recruitment into clinical trials. Trial Registration: ISRCTN30845205.",2019,"Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered.",['obese patients with type 2diabetes'],['Endobarrier versus standard medical therapy'],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]",[],,0.12075,"Although recruitment from primary care proved extremely successful at one study site, this largely failed at another site prompting the implementation of multimodal recruitment strategies including a successful media campaign to ensure sufficient participants were enrolled and the study was adequately powered.","[{'ForeName': 'Aruchuna', 'Initials': 'A', 'LastName': 'Ruban', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK aruchuna@doctors.org.uk.'}, {'ForeName': 'Christina Gabriele', 'Initials': 'CG', 'LastName': 'Prechtl', 'Affiliation': 'Department of Public Health, Imperial College Healthcare NHS Trust, London, London, UK.'}, {'ForeName': 'Michael Alan', 'Initials': 'MA', 'LastName': 'Glaysher', 'Affiliation': 'Division of Surgery, Southampton Biomedical Research Centre, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Navpreet', 'Initials': 'N', 'LastName': 'Chhina', 'Affiliation': 'PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Werd', 'Initials': 'W', 'LastName': 'Al-Najim', 'Affiliation': 'Dietician, Imperial College London, London, UK.'}, {'ForeName': 'Alexander Dimitri', 'Initials': 'AD', 'LastName': 'Miras', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolic Medicine, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'P Goldstone', 'Affiliation': 'PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Department of Diabetes and Endocrinology, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care Medical Group, University of Southampton Medical School, Southampton, UK.'}, {'ForeName': 'Hutan', 'Initials': 'H', 'LastName': 'Ashrafian', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Byrne', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Teare', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032439']
427,31804680,Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial.,"Importance


Malignant pleural effusion (MPE) is challenging to manage. Talc pleurodesis is a common and effective treatment. There are no reliable data, however, regarding the optimal method for talc delivery, leading to differences in practice and recommendations.
Objective


To test the hypothesis that administration of talc poudrage during thoracoscopy with local anesthesia is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis.
Design, Setting, and Participants


Open-label, randomized clinical trial conducted at 17 UK hospitals. A total of 330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018. Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia. Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung.
Interventions


Patients randomized to the talc poudrage group (n = 166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation, while patients randomized to the control group (n = 164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry.
Main Outcomes and Measures


The primary outcome was pleurodesis failure up to 90 days after randomization. Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days.
Results


Among 330 patients who were randomized (mean age, 68 years; 181 [55%] women), 320 (97%) were included in the primary outcome analysis. At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]). No statistically significant differences were noted in any of the 24 prespecified secondary outcomes.
Conclusions and Relevance


Among patients with malignant pleural effusion, thoracoscopic talc poudrage, compared with talc slurry delivered via chest tube, resulted in no significant difference in the rate of pleurodesis failure at 90 days. However, the study may have been underpowered to detect small but potentially important differences.
Trial Registration


ISRCTN Identifier: ISRCTN47845793.",2019,"At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]).","['Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia', 'Patients With Malignant Pleural Effusions', '330 patients who were randomized (mean age, 68 years', 'patients with malignant pleural effusion, thoracoscopic talc poudrage', 'Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung', '330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018']","['Talc pleurodesis', 'talc poudrage group (n\u2009=\u2009166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation', 'Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube', 'talc poudrage', 'bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry']","['Pleurodesis Failure Rate', 'pleurodesis failure rate', 'rate of pleurodesis failure', 'pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life', 'pleurodesis failure', 'cause mortality; and percentage of opacification on chest radiograph at drain removal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0405997', 'cui_str': 'Talc pleurodesis (procedure)'}, {'cui': 'C0039267', 'cui_str': 'Talc'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0189476', 'cui_str': 'Tube thoracostomy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449584', 'cui_str': 'Opacification (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain (procedure)'}]",330.0,0.381216,"At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]).","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Bhatnagar', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Hania E G', 'Initials': 'HEG', 'LastName': 'Piotrowska', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Laskawiec-Szkonter', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'Pragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernandez', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Justin C T', 'Initials': 'JCT', 'LastName': 'Pepperell', 'Affiliation': 'Somerset Lung Centre, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Evison', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Holme', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Al-Aloul', 'Affiliation': 'North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Lungs for Living Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Respiratory Medicine, Nottingham University Hospitals NHS Trust, United Kingdom.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'Glasgow Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Cox', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Downer', 'Affiliation': 'Respiratory Department, Sherwood Forest Hospitals Trust, United Kingdom.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Herre', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Pasupathy', 'Initials': 'P', 'LastName': 'Sivasothy', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Glan Clwyd Hospital, North Wales, United Kingdom.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Munavvar', 'Affiliation': 'Lancashire Teaching Hospitals NHS, Foundation Trust, Preston, United Kingdom.'}, {'ForeName': 'Moe M', 'Initials': 'MM', 'LastName': 'Kyi', 'Affiliation': 'Respiratory Department, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Doncaster, United Kingdom.'}, {'ForeName': 'Liju', 'Initials': 'L', 'LastName': 'Ahmed', 'Affiliation': ""Respiratory Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Alex G', 'Initials': 'AG', 'LastName': 'West', 'Affiliation': ""Respiratory Department, Guy's and St Thomas' NHS Trust, London, United Kingdom.""}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Harrison', 'Affiliation': 'Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': 'Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom.'}, {'ForeName': 'Gihan', 'Initials': 'G', 'LastName': 'Hettiarachchi', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, United Kingdom.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Chakrabarti', 'Affiliation': 'Aintree University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Ajikumar', 'Initials': 'A', 'LastName': 'Kavidasan', 'Affiliation': 'Milton Keynes University Hospital, Milton Keynes, United Kingdom.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Sutton', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Zahan-Evans', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Jack L', 'Initials': 'JL', 'LastName': 'Quaddy', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Edey', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Amelia O', 'Initials': 'AO', 'LastName': 'Clive', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Walker', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Matthew H R', 'Initials': 'MHR', 'LastName': 'Little', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Xue W', 'Initials': 'XW', 'LastName': 'Mei', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Harvey', 'Affiliation': 'North Bristol Lung Centre, North Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Hooper', 'Affiliation': 'Worcester Acute Hospitals NHS Trust, Worcester, United Kingdom.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Davies', 'Affiliation': 'Cardiff and Vale University Health Board, Wales, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Slade', 'Affiliation': 'Department of Respiratory Medicine, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Sivier', 'Affiliation': ''}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Miller', 'Affiliation': 'Institute for Global Health, University College London, London, United Kingdom.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.'}]",JAMA,['10.1001/jama.2019.19997']
428,31869756,Predicting first attendance at psychiatry appointments in patients with dissociative seizures.,"PURPOSE


Patients with dissociative (non-epileptic) seizures typically receive their diagnosis from neurologists, but are often referred to psychiatrists, whom they may be reluctant to go and see. We aimed to assess which factors were associated with first attendance at psychiatric services.
METHODS


A cohort study of 698 participants involved in the pre-randomisation phase of the CODES trial, a randomised controlled trial assessing the benefit of cognitive behavioural therapy for dissociative seizures when added to standardised medical (including psychiatric) care. Patients diagnosed by neurologists from 27 UK centres provided demographic information and a measure of diagnostic confidence. Neurologists described predominant seizure type and comorbidity with epilepsy. We analysed hypothesised (young age, male, residing in areas of higher deprivation, low belief in diagnosis) and exploratory factors for their association with first attendance with the psychiatrist about 3 months later.
RESULTS


568/698 (81.4 %) participants attended a psychiatry appointment. None of the following were associated with attendance: Location, age, gender, deprivation score, relationship status, ethnicity, level of education, employment status, receipt of disability benefits, duration, previous diagnosis of epilepsy or mental health problems and degree of confidence in the diagnosis. The only variable differing between groups was having a carer (21.5 % not attending vs 38.6 % attending).
CONCLUSION


First attendance at a psychiatry appointment after a neurologist had given a diagnosis of dissociative seizures was not associated with any hypothesised predictors, including patient confidence in the diagnosis. Neurologists should put aside any expectations about these variables when referring to and anticipating attendance with a psychiatrist.",2020,"The only variable differing between groups was having a carer (21.5 % not attending vs 38.6 % attending).
","['568/698 (81.4 %) participants attended a psychiatry appointment', '698 participants involved in the pre-randomisation phase of the CODES trial', 'patients with dissociative seizures', 'Patients with dissociative (non-epileptic) seizures']",['cognitive behavioural therapy'],"['deprivation score, relationship status, ethnicity, level of education, employment status, receipt of disability benefits, duration, previous diagnosis of epilepsy or mental health problems and degree of confidence']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349245', 'cui_str': 'Sham seizures'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242271', 'cui_str': 'Employment status (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",698.0,0.10735,"The only variable differing between groups was having a carer (21.5 % not attending vs 38.6 % attending).
","[{'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. Electronic address: jon.stone@ed.ac.uk.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Callaghan', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. Electronic address: hannah.callaghan.19@ucl.ac.uk.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Robinson', 'Affiliation': ""King's College London, School of Population Health and Environmental Sciences, UK. Electronic address: emily.robinson@kcl.ac.uk.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Carson', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, UK. Electronic address: a.carson@ed.ac.uk.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK. Electronic address: m.reuber@sheffield.ac.uk.'}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK. Electronic address: trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK. Electronic address: iain.perdue@kcl.ac.uk.""}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}]",Seizure,['10.1016/j.seizure.2019.11.014']
429,32151645,Clinical and virological responses to a broad-spectrum human monoclonal antibody in an influenza virus challenge study.,"Influenza A infections cause significant seasonal morbidity and mortality as well as periodic pandemic infections. Currently, no approved therapies exist for patients hospitalized with influenza. The efficacy of VIS410, a broadly neutralizing human immunoglobulin IgG1 monoclonal antibody engineered to bind to the stem region of group 1 and 2 influenza A hemagglutinins, was explored in experimental human influenza infection. Healthy volunteers were inoculated with influenza A/California/07/2009 (H1N1) and received a single dose of VIS410 or placebo 24 h later. Subjects were monitored for symptoms, viral shedding, and safety, including cytokine measurements. The primary efficacy endpoint was the area under the curve (AUC) of viral load (VL) in the VIS410 group versus placebo. VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024). Similar VIS410 antiviral activity was observed by virus culture, with a 91% reduction in median VL AUC by TCID 50  (p = 0.019) compared to placebo-treated volunteers. Influenza symptoms were generally mild or moderate, with a trend toward faster resolution in VIS410-treated subjects. Treatment with VIS410 was generally safe, with an increase in gastrointestinal events that were largely mitigated by pre-treatment with oral diphenhydramine (50 mg) in combination with 600 mg of ibuprofen. Transient elevation of specific cytokines (IL-8 and TNFα) were associated with gastrointestinal adverse events. Treatment with VIS410 did not interfere with the endogenous immune response to influenza A. These data indicate that VIS410 may provide therapeutic benefit in influenza A infection. TRIAL REGISTRATION: ClinicaTtrials.gov Identification NCT02468115; https://clinicaltrials.gov/ct2/show/NCT02468115?term=NCT02468115&rank=1).",2020,VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024).,"['patients hospitalized with influenza', 'Healthy volunteers']","['VIS410', 'ibuprofen', 'placebo', 'influenza A/California/07/2009 (H1N1) and received a single dose of VIS410 or placebo', 'oral diphenhydramine']","['area under the curve (AUC) of viral load (VL', 'Transient elevation of specific cytokines (IL-8 and TNFα', 'Influenza symptoms', 'gastrointestinal events', 'Similar VIS410 antiviral activity', 'symptoms, viral shedding, and safety, including cytokine measurements', 'median VL AUC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.063666,VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024).,"[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Sloan', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA.'}, {'ForeName': 'Kristy J', 'Initials': 'KJ', 'LastName': 'Szretter', 'Affiliation': 'Takeda Pharmaceuticals International, Inc., Cambridge, Massachusetts 02139, USA.'}, {'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Sundaresh', 'Affiliation': 'Boston College, Chestnut Hill, MA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Narayan', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Certara, Parsippany, NJ, 07054, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skurnik', 'Affiliation': ""Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Institut Necker-Enfants Malades, INSERM U1151, CNRS UMR, 8253, Paris, France; Université Paris Descartes, Paris, France; Service de Microbiologie, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Bedard', 'Affiliation': 'Clin Ops Solutions, Medford, MA, USA.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Trevejo', 'Affiliation': 'SmartPharm Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oldach', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Shriver', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA. Electronic address: zshriver@visterrainc.com.'}]",Antiviral research,['10.1016/j.antiviral.2020.104763']
430,32147280,Manual Versus Digital Aspiration for First-Line Treatment of Primary Spontaneous Pneumothorax. The AMVADI Study: A Randomized Clinical Trial.,"INTRODUCTION


The effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied. The objective of this research was to compare digital with manual aspiration in a randomized clinical trial.
METHODS


We designed a blinded parallel-group randomized clinical trial with a 1:1 allocation ratio. The clinical trial is reported in line with the guidelines of the CONSORT group. The primary outcome variables were immediate success and hospital admission, while the secondary outcome measures were relapse, re-admission and need for surgery, and length of hospital stay. A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration.
RESULTS


A total of 67 patients were included in the study (n=36, control group; n=31, experimental group) with no losses to follow-up. In both groups, 58% of procedures were immediately successful, avoiding hospital admission. No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay. Overall, 80% of clinicians who performed aspiration preferred the digital system, and this preference rose to 100% among clinicians who performed more than 5procedures a year.
CONCLUSIONS


Both manual and digital aspiration provide good immediate results avoiding hospital admission, while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax.",2020,"No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay.","['primary spontaneous pneumothorax', 'Primary Spontaneous Pneumothorax', 'A total of 67 patients were included in the study (n=36, control group; n=31, experimental group) with no losses to follow-up']","['Manual Versus Digital Aspiration', 'needle aspiration']","['relapse, re-admission and need for surgery, and length of hospital stay', 'immediate success and hospital admission', 'immediately successful, avoiding hospital admission', 'rates of relapse, re-admission, need for surgery, or length of hospital stay']","[{'cui': 'C0149781', 'cui_str': 'Primary Spontaneous Pneumothorax'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",67.0,0.127999,"No differences were found in rates of relapse, re-admission, need for surgery, or length of hospital stay.","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Aguinagalde', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Zabaleta', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España. Electronic address: jon.zabaletajimenez@osakidetza.eus.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Fernández-Monge', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Iker', 'Initials': 'I', 'LastName': 'Lopez', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Izquierdo', 'Affiliation': 'Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Redin', 'Affiliation': 'Servicio de Urgencias Generales, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'López', 'Affiliation': 'Servicio de Urgencias Generales, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}, {'ForeName': 'Jose Ignacio', 'Initials': 'JI', 'LastName': 'Emparanza', 'Affiliation': 'Servicio de Epidemiología Clínica, Hospital Universitario Donostia, Donostia, Gipuzkoa, España.'}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.01.016']
431,31745072,High-dose eicosapentaenoic acid (EPA) improves attention and vigilance in children and adolescents with attention deficit hyperactivity disorder (ADHD) and low endogenous EPA levels.,"No studies have examined the relationship between endogenous polyunsaturated fatty acids (PUFAs) levels and treatment response to PUFAs. We conducted a 12-week, double-blind, placebo-controlled trial comparing the effects of high-dose eicosapentaenoic acid (EPA, 1.2 g) and placebo on cognitive function (continuous performance test) in n = 92 youth (age 6-18-years-old) with Attention Deficit Hyperactivity Disorder (ADHD). Blood erythrocytes PUFAs were measured before and after treatment, to examine the effects of baseline endogenous EPA levels on treatment response and the effects of EPA treatment on PUFAs levels. Secondary measures included other ADHD symptoms, emotional symptoms, and levels of plasma high-sensitivity c-reactive protein (hs-CRP) and brain-derived neurotrophic factor (BDNF). Overall, EPA group improved more than placebo group on focused attention (variability, Effect size (ES) = 0.38, p = 0.041); moreover, within youth with the lowest baseline endogenous EPA levels, EPA group improved more than placebo group in another measure of focused attention (hit reaction time, HRT, ES = 0.89, p = 0.015) and in vigilance (HRT interstimulus interval changes, HRTISIC, ES = 0.83, p = 0.036). Interestingly, EPA group improved less than placebo group in impulsivity (commission errors), both overall and in youth with the highest baseline EPA levels, who also showed less improvement in other ADHD and emotional symptoms. EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels. In conclusion, EPA treatment improves cognitive symptoms in ADHD youth, especially if they have a low baseline endogenous EPA level, while youth with high EPA levels may be negatively affected by this treatment.",2019,"EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels.","['children and adolescents with attention deficit hyperactivity disorder (ADHD', 'n\u2009=\u200992 youth (age 6-18-years-old) with Attention Deficit Hyperactivity Disorder (ADHD']","['placebo', 'eicosapentaenoic acid (EPA', 'high-dose eicosapentaenoic acid (EPA, 1.2\u2009g) and placebo', 'EPA']","['blood erythrocytes EPA', 'endogenous polyunsaturated fatty acids (PUFAs) levels', 'ADHD and emotional symptoms', 'cognitive symptoms', 'Blood erythrocytes PUFAs', 'impulsivity (commission errors', 'hs-CRP and BDNF plasma levels', 'vigilance (HRT interstimulus interval changes', 'cognitive function (continuous performance test', 'PUFAs levels', 'ADHD symptoms, emotional symptoms, and levels of plasma high-sensitivity c-reactive protein (hs-CRP) and brain-derived neurotrophic factor (BDNF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}]","[{'cui': 'C0005768'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",92.0,0.570182,"EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels.","[{'ForeName': 'Jane Pei-Chen', 'Initials': 'JP', 'LastName': 'Chang', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK. cobolsu@gmail.com.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Mondelli', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}, {'ForeName': 'Senthil Kumaran', 'Initials': 'SK', 'LastName': 'Satyanarayanan', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Yang', 'Affiliation': 'College of Nutrition, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Chiang', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}]",Translational psychiatry,['10.1038/s41398-019-0633-0']
432,31345462,"Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial.","BACKGROUND


Identifying new antifungals for cryptococcal meningitis is a priority given the inadequacy of current therapy. Sertraline has previously shown in vitro and in vivo activity against cryptococcus. We aimed to assess the efficacy and cost-effectiveness of adjunctive sertraline in adults with HIV-associated cryptococcal meningitis compared with placebo.
METHODS


In this double-blind, randomised, placebo-controlled trial, we recruited HIV-positive adults with cryptococcal meningitis from two hospitals in Uganda. Participants were randomly assigned (1:1) to receive standard therapy with 7-14 days of intravenous amphotericin B (0·7-1·0 mg/kg per day) and oral fluconazole (starting at 800 mg/day) with either adjunctive sertraline or placebo. Sertraline was administered orally or via nasogastric tube at a dose of 400 mg/day for 2 weeks, followed by 200 mg/day for 12 weeks, then tapered off over 3 weeks. The primary endpoint was 18-week survival, analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT01802385.
FINDINGS


Between March 9, 2015, and May 29, 2017, we screened 842 patients with suspected meningitis and enrolled 460 of a planned 550 participants, at which point the trial was stopped for futility. Three patients in the sertraline group and three patients in the placebo group were lost to follow-up and therefore discontinued before study end. At 18 weeks, 120 (52%) of 229 patients in the sertraline group and 106 (46%) of 231 patients in the placebo group had died (hazard ratio 1·21, 95% CI 0·93-1·57; p=0·15). The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10  CFU/mL per day [95% CI 0·37-0·50] in the sertraline group vs 0·47 -log 10  CFU/mL per day [0·40-0·54] in the placebo group; p=0·59), as was occurrence of grade 4 or 5 adverse events (72 [31%] of 229 vs 75 [32%] of 231; p=0·98), most of which were associated with amphotericin B toxicity.
INTERPRETATION


Sertraline did not reduce mortality and should not be used to treat patients with HIV-associated cryptococcal meningitis. The reasons for sertraline inactivity appear to be multifactorial and might be associated with insufficient duration of therapeutic sertraline concentrations.
FUNDING


National Institutes of Health and Medical Research Council, Wellcome Trust.",2019,The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10  CFU/mL per day,"['group vs 0·47 -log 10', 'adults with HIV-associated cryptococcal meningitis', 'HIV-positive adults with cryptococcal meningitis from two hospitals in Uganda', 'HIV-associated cryptococcal meningitis', 'Between March 9, 2015, and May 29, 2017', '842 patients with suspected meningitis and enrolled 460 of a planned 550 participants, at which point the trial was stopped for futility', 'patients with HIV-associated cryptococcal meningitis']","['sertraline', 'adjunctive sertraline or placebo', 'standard therapy with 7-14 days of intravenous amphotericin B (0·7-1·0 mg/kg per day) and oral fluconazole', 'Adjunctive sertraline', 'placebo', 'adjunctive sertraline', 'Sertraline']","['18-week survival, analysed by intention-to-treat', 'amphotericin B toxicity', 'efficacy and cost-effectiveness', 'fungal clearance rate from cerebrospinal fluid', 'occurrence of grade 4 or 5 adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085436', 'cui_str': 'Meningitis, Cryptococcal'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0086322', 'cui_str': 'Futility'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",550.0,0.816271,The fungal clearance rate from cerebrospinal fluid was similar between groups (0·43 -log 10  CFU/mL per day,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Rhein', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda. Electronic address: joshua.rhein@gmail.com.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Huppler Hullsiek', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Tugume', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Nuwagira', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mpoza', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Evans', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Kiggundu', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ssebambulidde', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Akampurira', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'School of Public Health, Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Abdu K', 'Initials': 'AK', 'LastName': 'Musubire', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Muzoora', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA; Infectious Diseases Institute, Makerere University, Kampala, Uganda; School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, Medical School, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30127-6']
433,31682327,A pragmatic clinical trial examining the impact of a resilience program on college student mental health.,"BACKGROUND


One in three college students experience significant depression or anxiety interfering with daily functioning. Resilience programs that can be administered to all students offer an opportunity for addressing this public health problem. The current study objective was to assess the benefit of a brief, universal resilience program for first-year college students.
METHOD


First-year students at a private, midwestern university participated. This trial used a pragmatic design, delivering the intervention within university-identified orientation courses and was not randomized. The four-session resilience program included goal-building, mindfulness, and resilience skills. The comparison was orientation-as-usual. Primary outcomes included PROMIS® Depression and Anxiety and Connor-Davidson Resilience Scale. Secondary and exploratory outcomes included the Perceived Stress Scale, Emotion Regulation, and Cognitive Behavioral Therapy (CBT) Skills Questionnaires, and Freiburg Mindfulness Inventory. Time by treatment interactions at post-training and semester-end were examined using linear mixed models.
RESULTS


Analysis included 252 students, 126 who completed resilience programming and a matched comparison sample. Resilience programming did not relate to improvements in depression at post-training (CI: -2.53 to 1.02; p = .404, d =-0.08), but did at semester-end (95% CI: -4.27 to -0.72; p = .006, d = -0.25) and improvements in perceived stress were observed at post-training (CI: -3.31 to -0.44; p = .011, d = -0.24) and semester-end (CI: -3.30 to -0.41; p = .013, d = -0.24). Emotion regulation, mindfulness, and CBT skills increased, with CBT skills mediating clinical improvements.
CONCLUSIONS


Universal implementation of a brief, resilience intervention may be effective for improving college student mental health.",2020,"Resilience programming did not relate to improvements in depression at post-training (CI: -2.53 to 1.02; p = .404, d =-0.08), but did at semester-end (95% CI: -4.27 to -0.72; p = .006, d = -0.25) and improvements in perceived stress were observed at post-training (CI: -3.31 to -0.44; p = .011, d = -0.24) and semester-end (CI: -3.30 to -0.41","['first-year college students', 'college student mental health', 'First-year students at a private, midwestern university participated', 'three college students experience significant depression or anxiety interfering with daily functioning', '252 students, 126 who completed resilience programming and a matched comparison sample']","['universal resilience program', 'resilience program']","['goal-building, mindfulness, and resilience skills', 'Perceived Stress Scale, Emotion Regulation, and Cognitive Behavioral Therapy (CBT) Skills Questionnaires, and Freiburg Mindfulness Inventory', 'PROMIS® Depression and Anxiety and Connor-Davidson Resilience Scale', 'Emotion regulation, mindfulness, and CBT skills increased, with CBT skills mediating clinical improvements', 'perceived stress']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521102', 'cui_str': 'Interferes with (contextual qualifier) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0627337,"Resilience programming did not relate to improvements in depression at post-training (CI: -2.53 to 1.02; p = .404, d =-0.08), but did at semester-end (95% CI: -4.27 to -0.72; p = .006, d = -0.25) and improvements in perceived stress were observed at post-training (CI: -3.31 to -0.44; p = .011, d = -0.24) and semester-end (CI: -3.30 to -0.41","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Akeman', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, Oklahoma.'}, {'ForeName': 'Namik', 'Initials': 'N', 'LastName': 'Kirlic', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, Oklahoma.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Clausen', 'Affiliation': 'VA Mid-Atlantic Mental Illness Research, Education and Clinical Center, Durham, North Carolina.'}, {'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Cosgrove', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, Oklahoma.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'McDermott', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Cromer', 'Affiliation': 'Department of Psychology, University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, Oklahoma.'}, {'ForeName': 'Hung-Wen', 'Initials': 'HW', 'LastName': 'Yeh', 'Affiliation': ""Health Services & Outcomes Research, Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Aupperle', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, Oklahoma.'}]",Depression and anxiety,['10.1002/da.22969']
434,31622684,Patient Portal Usage and Outcomes Among Adult Patients with Uncontrolled Asthma.,"BACKGROUND


Patient-clinician communication, essential for favorable asthma outcomes, increasingly relies on information technology including the electronic heath record-based patient portal. For patients with chronic disease living in low-income neighborhoods, the benefits of portal communication remain unclear.
OBJECTIVE


To describe portal activities and association with 12-month outcomes among low-income patients with asthma formally trained in portal use.
METHODS


In a longitudinal observational study within a randomized controlled trial, 301 adults with uncontrolled asthma were taught 7 portal tasks: reviewing upcoming appointments, scheduling appointments, reviewing medications, locating laboratory results, locating immunization records, requesting refills, and messaging. Half the patients were randomized to receive up to 4 home visits by community health workers. Patients' portal use by activities, rate of usage over time, frequency of appointments with asthma physicians, and asthma control and quality of life were assessed over time and estimated as of 12 months from randomization.
RESULTS


Fewer than 60% of patients used the portal independently. Among users, more than half used less than 1 episode per calendar quarter. The most frequent activities were reading messages and viewing laboratory results and least sending messages and making appointments. Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12-month postintervention.
CONCLUSIONS


Patients with uncontrolled asthma used the portal irregularly if at all, despite in-person training. Usage was not associated with regular appointments or with clinical outcomes. Patient portals need modification to accommodate low-income patients with uncontrolled asthma.",2020,"Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12 months' post intervention.
","['low-income patients with uncontrolled asthma', 'patients with chronic disease living in low-income neighborhoods', 'low-income asthma patients formally trained in portal use', 'Patients with uncontrolled asthma used the portal irregularly if at all, despite in-person training', 'Adult Patients with Uncontrolled Asthma', '301 adults with uncontrolled asthma were taught 7 portal tasks']",[],"['quality of life', 'Patient Portal Usage and Outcomes', ""Patients' portal use by activities, rate of usage over time, frequency of appointments with asthma physicians, and asthma control and quality of life""]","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",301.0,0.0512118,"Higher rates of portal use were not associated with keeping regular appointments during follow-up, better asthma control, or higher quality of life at 12 months' post intervention.
","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa. Electronic address: andrea.apter@uphs.upenn.edu.'}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Howell', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Mullen', 'Affiliation': 'Temple University Health System, Philadelphia, Pa.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Maryori', 'Initials': 'M', 'LastName': 'Canales', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Localio', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.09.034']
435,31786154,"Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial.","BACKGROUND


Atopic dermatitis is a chronic inflammatory skin disease characterized by pruritic skin lesions.
OBJECTIVE


We sought to evaluate the safety and efficacy of multiple doses of the selective Janus kinase 1 inhibitor upadacitinib in patients with moderate to severe atopic dermatitis.
METHODS


In the 16-week, double-blind, placebo-controlled, parallel-group, dose-ranging portion of this 88-week trial in 8 countries (ClinicalTrials.gov, NCT02925117; ongoing, not recruiting), adults with moderate to severe disease and inadequate control by topical treatment were randomized 1:1:1:1, using an interactive response system and stratified geographically, to once-daily upadacitinib oral monotherapy 7.5, 15, or 30 mg or placebo. The primary end point was percentage improvement in Eczema Area and Severity Index from baseline at week 16. Efficacy was analyzed by intention-to-treat in all randomized patients. Safety was analyzed in all randomized patients who received study medication, based on actual treatment.
RESULTS


Patients (N = 167) enrolled from November 21, 2016, to April 20, 2017. All were randomized and analyzed for efficacy (each upadacitinib group, n = 42; placebo, n = 41); 166 were analyzed for safety (each upadacitinib group, n = 42; placebo, n = 40). The mean (SE) primary efficacy end point was 39% (6.2%), 62% (6.1%), and 74% (6.1%) for the upadacitinib 7.5-, 15-, and 30-mg groups, respectively, versus 23% (6.4%) for placebo (P = .03, <.001, and <.001). Serious adverse events occurred in 4.8% (2 of 42), 2.4% (1 of 42), and 0% (0 of 42) of upadacitinib groups (vs 2.5% [1 of 40] for placebo).
CONCLUSIONS


A dose-response relationship was observed for upadacitinib efficacy; the 30-mg once-daily dose showed the greatest clinical benefit. Dose-limiting toxicity was not observed.",2020,"Serious adverse events occurred in 4.8% [2/42], 2.4% [1/42], 0% [0/42] of upadacitinib groups (vs 2.5% [1/40] for placebo).
","['patients with moderate-to-severe atopic dermatitis', 'Patients (N=167) enrolled from November 21, 2016, to April 20, 2017', 'adults with moderate-to-severe disease and inadequate control by topical treatment', 'Adults With Moderate-to-Severe Atopic Dermatitis']","['placebo', 'Placebo', 'selective Janus kinase 1 inhibitor upadacitinib']","['mean (standard error) primary efficacy endpoint', 'Efficacy', 'Serious adverse events', 'percentage improvement in Eczema Area and Severity Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0169658', 'cui_str': 'Jak1 Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",166.0,0.619899,"Serious adverse events occurred in 4.8% [2/42], 2.4% [1/42], 0% [0/42] of upadacitinib groups (vs 2.5% [1/40] for placebo).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: emma.guttman@mountsinai.org.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'Immunology Clinical Development, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'H Chih-Ho', 'Initials': 'HC', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia and Probity Medical Research, Surrey, British Columbia, Canada.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation Center, Hamburg, Germany.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Jaclyn K', 'Initials': 'JK', 'LastName': 'Anderson', 'Affiliation': 'Immunology Clinical Development, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Data and Statistical Sciences, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Henrique D', 'Initials': 'HD', 'LastName': 'Teixeira', 'Affiliation': 'Immunology Clinical Development, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.11.025']
436,30895903,"Cervical cerclage, pessary, or vaginal progesterone in high-risk pregnant women with short cervix: a randomized feasibility study.","Objective:  To assess feasibility for a definitive randomized controlled trial (RCT) comparing three treatments for short cervix in a population at high risk for spontaneous preterm birth (sPTB) over a 1-year period. Design:  Three arm, open label feasibility randomized clinical study. Methods:  Women with singleton pregnancy with risk factors for sPTB (history of sPTB or prelabor premature rupture of membranes (PPROM) <34 weeks or significant cervical surgery), and short cervix on transvaginal ultrasound scan detected between 16 +0  and 24 +6  weeks gestation were randomized to receive either cervical cerclage, vaginal pessary, or vaginal progesterone 200 mg nocte. Pregnancy outcomes and treatment costs were collected from hospital records, NHS Reference costs, and British National Formulary costs. Main outcome measures:  Feasibility targets were defined as (i) at least 55% of eligible women randomized; (ii) maximum 5% failure to adhere to the protocol per arm; (iii) maximum 5% loss to short-term follow-up. Results:  Of 417 women screened between October 2015 and 2016, 25 (6%) were eligible for trial inclusion, of whom 18 (72%) agreed to participate at the rate 0.75 participants/site/month. Adherence to protocol was 100% in pessary and cerclage arms and 80% in vaginal progesterone arm (95% CI 24-100%). No participants were lost to follow up. Cost of interventions accounted for 6% (95% CI 2-10%) of overall health care expenditure. Conclusions:  A definitive clinical trial comparing treatments for prevention of sPTB in high-risk women with short cervix is feasible but will be challenging due to small numbers of eligible participants.",2021,Adherence to protocol was 100% in pessary and cerclage arms and 80% in vaginal progesterone arm (95% CI 24-100%).,"['short cervix in a population at high risk for spontaneous preterm birth (sPTB) over a 1-year period', 'high-risk pregnant women with short cervix', 'Women with singleton pregnancy with risk factors for sPTB (history of sPTB or prelabor premature rupture of membranes', 'Of 417 women screened between October 2015 and 2016, 25 (6%) were eligible for trial inclusion, of whom 18 (72%) agreed to participate at the rate 0.75 participants/site/month', 'high-risk women with short cervix']","['Cervical cerclage, pessary, or vaginal progesterone', 'vaginal progesterone', 'cervical cerclage, vaginal pessary, or vaginal progesterone 200']","['Pregnancy outcomes and treatment costs', 'short cervix on transvaginal ultrasound scan', 'hospital records, NHS Reference costs, and British National Formulary costs']","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3853999', 'cui_str': 'Cervical cerclage (physical object)'}, {'cui': 'C0031246', 'cui_str': 'Pessaries'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1136199', 'cui_str': 'Vaginal Suppository'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography (procedure)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0282300', 'cui_str': 'National Formulary'}]",,0.314563,Adherence to protocol was 100% in pessary and cerclage arms and 80% in vaginal progesterone arm (95% CI 24-100%).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Care', 'Affiliation': ""Centre for Women and Children's Health Research, Harris-Wellbeing Preterm Birth Research Group, University of Liverpool, Liverpool Women's Hospital, Liverpool, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': ""O'Brien"", 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leigh', 'Affiliation': 'Management School, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cornforth', 'Affiliation': 'Liverpool Clinical Trials Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haycox', 'Affiliation': 'Management School, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whitworth', 'Affiliation': ""Saint Mary's Hospital, Manchester, UK.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lavender', 'Affiliation': 'Division of Nursing, Manchester, UK.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Alfirevic', 'Affiliation': ""Centre for Women and Children's Health Research, Harris-Wellbeing Preterm Birth Research Group, University of Liverpool, Liverpool Women's Hospital, Liverpool, UK.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1588245']
437,30514400,Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial.,"BACKGROUND


Chronic subdural haematoma (CSDH) is a common neurosurgical condition, typically treated with surgical drainage of the haematoma. However, surgery is associated with mortality and morbidity, including up to 20% recurrence of the CSDH. Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs. They have also been used as a conservative treatment option, thereby avoiding surgery altogether. The hypothesis of the Dex-CSDH trial is that a two-week course of dexamethasone in symptomatic patients with CSDH will lead to better functional outcome at six months. This is anticipated to occur through reduced number of hospital admissions and surgical interventions.
METHODS


Dex-CSDH is a UK multi-centre, double-blind randomised controlled trial of dexamethasone versus placebo for symptomatic adult patients diagnosed with CSDH. A sample size of 750 patients has been determined, including an initial internal pilot phase of 100 patients to confirm recruitment feasibility. Patients must be recruited within 72 h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis. The decision regarding surgical intervention will be made by the clinical team and patients can be included in the trial regardless of whether operative treatment is planned or has been performed. The primary outcome measure is the modified Rankin Scale (mRS) at six months. Secondary outcomes include the number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three months, EQ-5D at three and six months, adverse events, mortality and a health-economic analysis.
DISCUSSION


This multi-centre trial will provide high-quality evidence as to the effectiveness of dexamethasone in the treatment of CSDH. This has implications for patient morbidity and mortality as well as a potential economic impact on the overall health service burden from this condition.
TRIAL REGISTRATION


ISRCTN, ISRCTN80782810 . Registered on 7 November 2014. EudraCT, 2014-004948-35 . Registered on 20 March 2015. Dex-CSDH trial protocol version 3, 27 Apr 2017. This protocol was developed in accordance with the SPIRIT checklist. Available as a separate document on request.",2018,"Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs.","['Patients must be recruited within 72\u2009h of admission to a neurosurgical unit and exclusions include patients already on steroids or with steroid contraindications, patients who have a cerebrospinal fluid shunt and those with a history of psychosis', '750 patients', 'adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial', 'symptomatic adult patients diagnosed with CSDH', 'symptomatic patients with CSDH']","['Dex-CSDH', 'Dexamethasone', 'dexamethasone', 'placebo']","['number of CSDH-related surgical interventions during follow-up, length of hospital stay, mRS at three\u2009months, EQ-5D at three and six\u2009months, adverse events, mortality and a health-economic analysis', 'modified Rankin Scale (mRS', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1301624', 'cui_str': 'Contraindications'}, {'cui': 'C0007812', 'cui_str': 'Cerebrospinal Fluid Shunts'}, {'cui': 'C3887134', 'cui_str': 'History of psychosis'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0749095', 'cui_str': 'Hemorrhage, Subdural, Chronic'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.325034,"Steroids, such as dexamethasone, have been identified as a potential therapy for reducing recurrence risk in surgically treated CSDHs.","[{'ForeName': 'Angelos G', 'Initials': 'AG', 'LastName': 'Kolias', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. ak721@cam.ac.uk.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Edlmann', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. ee291@cam.ac.uk.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Thelin', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Bulters', 'Affiliation': 'Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Tremona Rd, Southampton, Hampshire, SO16 6YD, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Holton', 'Affiliation': 'Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Tremona Rd, Southampton, Hampshire, SO16 6YD, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Suttner', 'Affiliation': 'Institute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Owusu-Agyemang', 'Affiliation': 'Institute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, UK.'}, {'ForeName': 'Yahia Z', 'Initials': 'YZ', 'LastName': 'Al-Tamimi', 'Affiliation': 'Department of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gatt', 'Affiliation': 'Department of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomson', 'Affiliation': 'Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Richards', 'Affiliation': 'Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whitfield', 'Affiliation': 'Southwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gherle', 'Affiliation': 'Southwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Caldwell', 'Affiliation': ""Division of Neurosurgery, Addenbrooke's Hospital, Box 167, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Davis-Wilkie', 'Affiliation': 'Cambridge Clinical Trials Unit (CCTU), Coton House, Level 6, Cambridge Biomedical Campus, Box 401, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tarantino', 'Affiliation': ""Division of Neurosurgery, Addenbrooke's Hospital, Box 167, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.'}, {'ForeName': 'Hani J', 'Initials': 'HJ', 'LastName': 'Marcus', 'Affiliation': 'Imperial College Healthcare NHS Trust, South Kensington Campus, London, SW7 2AZ, UK.'}, {'ForeName': 'Aswin', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Royal London Hospital, Barts Health NHS trust, Whitechapel Road, London, E1 1BB, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brennan', 'Affiliation': 'Department of Clinical Neurosciences, University of Edinburgh, Western General Hospitals NHS Trust, Crewe Road, Edinburgh, EH4 2XU, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Belli', 'Affiliation': 'NIHR Surgical Reconstruction and Microbiology Research Centre & University Hospitals Birmingham NHS Foundation Trust, School of Clinical and Experimental Medicine, University of Birmingham, Institute of Biomedical Research (West), Room WX 2.61, Edgbaston, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit (CCTU), Coton House, Level 6, Cambridge Biomedical Campus, Box 401, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Whitehead', 'Affiliation': ""Clinical Trials Pharmacy, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Wilkinson', 'Affiliation': 'Cambridge Clinical Trials Unit (CCTU), Coton House, Level 6, Cambridge Biomedical Campus, Box 401, Cambridge, CB2 0QQ, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hutchinson', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. pjah2@cam.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-018-3050-4']
438,30420171,Fecal Akkermansia muciniphila Is Associated with Body Composition and Microbiota Diversity in Overweight and Obese Women with Breast Cancer Participating in a Presurgical Weight Loss Trial.,"BACKGROUND


Akkermansia muciniphila (AM) is a gram-negative, mucin-degrading bacteria inhabiting the gastrointestinal tract associated with host phenotypes and disease states.
OBJECTIVE


Explore characteristics of overweight and obese female early-stage (0 to II) breast cancer patients with low AM relative abundance (LAM) vs high (HAM) enrolled in a presurgical weight-loss trial.
DESIGN


Secondary analysis of pooled participants in a randomized controlled trial (NCT02224807).
PARTICIPANTS/SETTING


During the period from 2014 to 2017, 32 female patients with breast cancer were randomized to weight-loss or attention-control arms from time of diagnosis-to-lumpectomy (mean=30±9 days).
INTERVENTION


All were instructed to correct nutrient deficiencies via food sources and on upper-body exercises. The weight-loss group received additional guidance to promote 0.5 to 1 kg/wk weight-loss via energy restriction and aerobic exercise.
MAIN OUTCOME MEASURES


At baseline and follow-up, sera, fecal samples, two-24 hour dietary recalls and dual x-ray absorptiometry were obtained. Bacterial DNA was isolated from feces and polymerase chain reaction (16S) amplified. Inflammatory cytokines were measured in sera.
STATISTICAL ANALYSES PERFORMED


Differences between LAM and HAM participants were analyzed using t tests and nonparametric tests. Spearman correlations explored relationships between continuous variables.
RESULTS


Participants were aged 61±9 years with body mass index 34.8±6. Mean AM relative abundance was 0.02% (0.007% to 0.06%) and 1.59% (0.59% to 13.57%) for LAM and HAM participants, respectively. At baseline, women with HAM vs LAM had lower fat mass (38.9±11.2 kg vs 46.4±9.0 kg; P=0.044). Alpha diversity (ie, species richness) was higher in women with HAM (360.8±84.8 vs 282.4±69.6; P=0.008) at baseline, but attenuated after weight-loss (P=0.058). At baseline, interleukin-6 level was associated with species richness (ρ=-0.471, P=0.008) and fat mass (ρ=0.529, P=0.002), but not AM. Change in total dietary fiber was positively associated with AM in LAM (ρ=0.626, P=0.002), but not HAM (ρ=0.436, P=0.180) participants.
CONCLUSIONS


Among women with early-stage breast cancer, body composition is associated with AM, microbiota diversity, and interleukin-6 level. AM may mediate the effects of dietary fiber in improving microbiota composition.",2020,"Change in total dietary fiber was positively associated with AM in LAM (ρ=0.626, P=0.002), but not HAM (ρ=0.436, P=0.180) participants.
","['overweight and obese female early-stage (0 to II) breast cancer patients with low AM relative abundance (LAM) vs high (HAM) enrolled in a presurgical weight-loss trial', '32 female patients with breast cancer', 'women with early-stage breast cancer', 'Participants were aged 61±9 years with body mass index 34.8±6', 'Overweight and Obese Women with Breast Cancer Participating in a Presurgical Weight Loss Trial']",['weight-loss or attention-control arms from time of diagnosis-to-lumpectomy (mean=30±9 days'],"['interleukin-6 level', 'Mean AM relative abundance', 'fat mass', 'Alpha diversity (ie, species richness', 'total dietary fiber', 'Inflammatory cytokines', 'lower fat mass']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",32.0,0.125547,"Change in total dietary fiber was positively associated with AM in LAM (ρ=0.626, P=0.002), but not HAM (ρ=0.436, P=0.180) participants.
","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Van der Pol', 'Affiliation': ''}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Casey D', 'Initials': 'CD', 'LastName': 'Morrow', 'Affiliation': ''}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Tsuruta', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2018.08.164']
439,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5']
440,32122284,Racial exclusion causes acute cortisol release among emerging-adult African Americans: The role of reduced perceived control.,"Racial discrimination contributes to stress-related health disparities among African Americans, but less is known about the acute effects of racial exclusion on the hypo-pituitary-adrenocortical response and psychological mediators. Participants were 276 Black/African American emerging-adults (54% female;  M   age  = 21.74,  SD  = 2.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball. Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  p  < .0001), lower perceived control ( F (1, 276) = 205.523,  p  < .0001), and greater cortisol release ( F (1, 274) = 4.575,  p  = .033). Racial exclusion's impact on cortisol release was mediated by lower perceived control (95% CI: .027, .112), but not negative affect (-.041, .013). These findings suggest that racial exclusion contributes to acute cortisol release, and that reduced perceived control is a consequence of racial discrimination that has important implications for the health of those who experience discrimination.",2020,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","['African Americans', 'adult African Americans', 'Participants were 276 Black/African American emerging-adults (54% female;  M age \xa0=\xa021.74,  SD \xa0=\xa02.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball']",[],"['greater cortisol release', 'cortisol release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517630', 'cui_str': '2.21'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",276.0,0.0475374,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","[{'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Monroe', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy-Paolillo', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}]",The Journal of social psychology,['10.1080/00224545.2020.1729685']
441,30395904,Daily Lisinopril vs Placebo for Prevention of Chemoradiation-Induced Pulmonary Distress in Patients With Lung Cancer (Alliance MC1221): A Pilot Double-Blind Randomized Trial.,"PURPOSE


Chemoradiation (CRT) is an integral treatment modality for patients with locally advanced lung cancer. It has been hypothesized that current use of an angiotensin-converting enzyme inhibitor during CRT may be protective for treatment-related lung damage and pneumonitis.
METHODS AND MATERIALS


We conducted a pilot, double-blind, placebo-controlled, randomized trial. Study-eligible patients receiving curative thoracic radiation therapy (RT) were randomly assigned to 20 mg of lisinopril or placebo once daily during and up to 3 months after RT. All patients received concurrent chemotherapy. The primary endpoint was adverse event profiling. Multiple patient-reported outcome (PRO) surveys, including the Lung Cancer Symptom Scale, Function Assessment of Cancer Therapy-Lung, and the European Organisation for Research and Treatment of Cancer Lung Cancer Questionnaire, were applied with a symptom experience questionnaire. Exploratory comparative statistics were used to detect differences between arms with χ 2  and Kruskal-Wallis testing.
RESULTS


Five institutions enrolled 23 patients. However, accrual was less than expected. Eleven and 12 patients were in the placebo and lisinopril arms, respectively (mean age, 63.5 years; male, 62%). Baseline characteristics were balanced. Eighteen patients (86%) were former or current smokers. The primary endpoint was met; neither arm had grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema). Few PRO measures suggested that compared with the placebo arm, patients receiving lisinopril had less cough, less shortness of breath, fewer symptoms from lung cancer, less dyspnea with both walking and climbing stairs, and better overall quality of life (for all, P < .05).
CONCLUSIONS


Although underpowered because of low accrual, our results suggest that there was a clinical signal for safety-and possibly beneficial by limited PRO measures-in concurrently administering lisinopril during thoracic CRT to mitigate or prevent RT-induced pulmonary distress. Our results showed that a definitive, larger-scale, randomized phase 3 trial is needed in the future.",2019,"The primary endpoint was met; neither arm had grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema).","['Five institutions enrolled 23 patients', 'arms, respectively (mean age, 63.5\xa0years; male, 62', 'Patients With Lung Cancer', 'Study-eligible patients receiving curative thoracic radiation therapy (RT', 'Eighteen patients (86%) were former or current smokers', 'patients with locally advanced lung cancer']","['Alliance MC1221', 'lisinopril', 'Chemoradiation (CRT', 'placebo', 'lisinopril or placebo', 'Daily Lisinopril vs Placebo', 'concurrent chemotherapy', 'placebo and lisinopril']","['Lung Cancer Symptom Scale, Function Assessment of Cancer Therapy-Lung, and the European Organisation for Research and Treatment of Cancer Lung Cancer Questionnaire', 'cough, less shortness of breath, fewer symptoms from lung cancer, less dyspnea with both walking and climbing stairs', 'overall quality of life', 'grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema', 'adverse event profiling']","[{'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C3241966'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1869027', 'cui_str': 'Angioedema (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",23.0,0.302562,"The primary endpoint was met; neither arm had grade 3 or higher hypotension, acute kidney injury, allergic reaction (medication-induced cough), or anaphylaxis (medication-related angioedema).","[{'ForeName': 'Terence T', 'Initials': 'TT', 'LastName': 'Sio', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona. Electronic address: Sio.Terence@mayo.edu.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Levi D', 'Initials': 'LD', 'LastName': 'Pederson', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'W Ken', 'Initials': 'WK', 'LastName': 'Zhen', 'Affiliation': 'Department of Radiation Oncology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Mutter', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yolanda I', 'Initials': 'YI', 'LastName': 'Garces', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Leenstra', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jean-Claude M', 'Initials': 'JM', 'LastName': 'Rwigema', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.'}, {'ForeName': 'Shaker', 'Initials': 'S', 'LastName': 'Dakhil', 'Affiliation': 'Department of Radiation Oncology, Cancer Center of Kansas, Wichita, Kansas.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Bearden', 'Affiliation': 'Department of Radiation Oncology, Spartanburg Medical Center, Spartanburg, South Carolina.'}, {'ForeName': 'Sonja J', 'Initials': 'SJ', 'LastName': 'van der Veen', 'Affiliation': 'Department of Radiation Oncology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Apar K', 'Initials': 'AK', 'LastName': 'Ganti', 'Affiliation': 'Division of Oncology-Hematology, Department of Internal Medicine, VA Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Miller', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Jacksonville, Florida.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2018.10.035']
442,29519670,Heterologous Two-Dose Vaccination with Simian Adenovirus and Poxvirus Vectors Elicits Long-Lasting Cellular Immunity to Influenza Virus A in Healthy Adults.,"BACKGROUND


T-cell responses against highly conserved influenza antigens have been previously associated with protection. However, these immune responses are poorly maintained following recovery from influenza infection and are not boosted by inactivated influenza vaccines. We have previously demonstrated the safety and immunogenicity of two viral vectored vaccines, modified vaccinia virus Ankara (MVA) and the chimpanzee adenovirus ChAdOx1 expressing conserved influenza virus antigens, nucleoprotein (NP) and matrix protein-1 (M1). We now report on the safety and long-term immunogenicity of multiple combination regimes of these vaccines in young and older adults.
METHODS


We conducted a Phase I open-label, randomized, multi-center study in 49 subjects aged 18-46years and 24 subjects aged 50years or over. Following vaccination, adverse events were recorded and the kinetics of the T cell response determined at multiple time points for up to 18months.
FINDINGS


Both vaccines were well tolerated. A two dose heterologous vaccination regimen significantly increased the magnitude of pre-existing T-cell responses to NP and M1 after both doses in young and older adults. The fold-increase and peak immune responses after a single MVA-NP+M1 vaccination was significantly higher compared to ChAdOx1 NP+M1. In a mixed regression model, T-cell responses over 18months were significantly higher following the two dose vaccination regimen of MVA/ChAdOx1 NP+M1.
INTERPRETATION


A two dose heterologous vaccination regimen of MVA/ChAdOx1 NP+M1 was safe and immunogenic in young and older adults, offering a promising vaccination strategy for inducing long-term broadly cross-reactive protection against influenza A.
FUNDING SOURCE


Medical Research Council UK, NIHR BMRC Oxford.",2018,A two dose heterologous vaccination regimen significantly increased the magnitude of pre-existing T-cell responses to NP and M1 after both doses in young and older adults.,"['young and older adults', '49 subjects aged 18-46years and 24 subjects aged 50years or over', 'Healthy Adults']","['heterologous vaccination regimen', 'MVA/ChAdOx1 NP+M1']","['peak immune responses', 'tolerated', 'magnitude of pre-existing T-cell responses', 'adverse events', 'kinetics of the T cell response']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",49.0,0.0188079,A two dose heterologous vaccination regimen significantly increased the magnitude of pre-existing T-cell responses to NP and M1 after both doses in young and older adults.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Coughlan', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Microbiology, Annenberg Building, Room 16.30, One Gustave Levy Place, New York 10029, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sridhar', 'Affiliation': ""Sanofi Pasteur, MARCY l'ETOILE, 69280, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Payne', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Edmans', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Milicic', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Venkatraman', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lugonja', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Clifton', 'Affiliation': 'Centre for Statistics in Medicine, NDORMS, University of Oxford, Botnar Research Centre, Windmill Road, Oxford OX3 7LD, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Qi', 'Affiliation': 'Centre for Statistics in Medicine, NDORMS, University of Oxford, Botnar Research Centre, Windmill Road, Oxford OX3 7LD, UK.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'de Graaf', 'Affiliation': 'NIHR Wellcome Trust Clinical Research Facility, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sukhtankar', 'Affiliation': 'NIHR Wellcome Trust Clinical Research Facility, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Wellcome Trust Clinical Research Facility, University of Southampton, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'D J M', 'Initials': 'DJM', 'LastName': 'Lewis', 'Affiliation': 'Clinical Research Centre, University of Surrey, Guildford GU2 7AX, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'Avs', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, University of Oxford, ORCRB, Roosevelt Drive, Oxford OX3 7DQ, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",EBioMedicine,['10.1016/j.ebiom.2018.02.011']
443,30630380,Conservative Fluid Management After Sepsis Resuscitation: A Pilot Randomized Trial.,"RATIONALE


The feasibility and clinical outcomes of conservative fluid management after sepsis resuscitation remain unknown.
OBJECTIVES


To evaluate the effect of a conservative fluid management protocol on fluid balance and intensive care unit (ICU)-free days among patients with sepsis.
METHODS


In a single-center phase II/III randomized trial, we enrolled adults with suspected infection, ≥2 systemic inflammatory response syndrome criteria, and either shock (mean arterial pressure <60 mm Hg or vasopressors) or respiratory insufficiency (mechanical ventilation or oxygen saturation <97% and fraction of inspired oxygen ≥0.3). Patients were randomized 1:1 to usual care or a conservative fluid management protocol. The protocol restricted intravenous fluid administration during shock to treatment of oliguria or increasing vasopressor requirement. In the absence of shock, loop diuretic infusion targeted equal fluid input and output each study day. The primary outcomes were mean daily fluid balance (phase II) and ICU-free days (phase III).
RESULTS


At the completion of phase II (n = 30), the difference in mean daily fluid balance between groups (-398 mL) was less than the prespecified threshold (-500 mL) and the trial was stopped. Patients in the conservative fluid management (n = 15) and usual care (n = 15) groups experienced similar cumulative fluid input (8450 mL vs 7049 mL;  P  = .90) of which only 14% was intravenous crystalloid or colloid. Loop diuretic infusion occurred more frequently in the conservative fluid management group (40% vs 0%;  P  = .02), and cumulative fluid output was 10 645 mL in the conservative fluid management group compared to 6286 mL in the usual care group ( P  = .39). Hemodynamic, respiratory, and renal function did not differ between the groups.
CONCLUSIONS


In this phase II trial, a conservative fluid management protocol did not decrease mean daily fluid balance by more than 500 mL among patients with sepsis.
REGISTRATION


Clinicaltrials.gov; NCT02159079.",2020,groups experienced similar cumulative fluid input (8450 mL vs 7049 mL; P = .90),"['After Sepsis Resuscitation', 'patients with sepsis', 'Patients in the conservative fluid management (n = 15) and usual care (n = 15', 'enrolled adults with suspected infection, ≥2 systemic inflammatory response syndrome criteria, and either shock (mean arterial pressure <60 mm Hg or vasopressors) or respiratory insufficiency (mechanical ventilation or oxygen saturation <97% and fraction of inspired oxygen ≥0.3']","['intravenous crystalloid or colloid', 'Conservative Fluid Management', 'usual care or a conservative fluid management protocol', 'conservative fluid management protocol']","['cumulative fluid output', 'mean daily fluid balance (phase II) and ICU-free days (phase III', 'fluid balance and intensive care unit (ICU)-free days', 'Hemodynamic, respiratory, and renal function', 'mean daily fluid balance']","[{'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0035229', 'cui_str': 'Respiratory Insufficiency'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429635', 'cui_str': 'Fluid output (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.159543,groups experienced similar cumulative fluid input (8450 mL vs 7049 mL; P = .90),"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': 'Section of Pulmonary/Critical Care & Allergy/Immunology, Louisiana State University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of intensive care medicine,['10.1177/0885066618823183']
444,30603800,Effects of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Swallowing Function and Quality of Life of Post-stroke Patients.,"Repetitive transcranial magnetic stimulation (rTMS) is one of the non-invasive techniques, which is used to modulate cortical regions in patients with stroke. The aim of this single blind, controlled study was to investigate the effect of rTMS on swallowing function and quality of life of mono-hemispheric post-stroke patients with dysphagia. Twenty-eight patients were randomized and split between study and control group. Each group received conventional dysphagia rehabilitation 3 days a week for 4 weeks, and study group also received 1 Hz rTMS to unaffected hemisphere in the final week. The descriptive information was noted. The clinical and radiological swallowing evaluation and quality of life assessment have been performed at four different times including before and after the treatment, 1 month and 3 months after the treatment. At baseline, no significant differences were observed between groups in terms of demographic and clinical features (p > 0.05). Swallowing function and quality of life of the patients were statistically improved in both groups towards the third month (p < 0.05). Swallowing function was comparable between two groups. However, a significant improvement was observed on appetite, fear of eating, and mental health parameters of quality of life assessment in the study group compared to the control group (p < 0.05). In conclusion, despite positive changes in some aspects of quality of life, rTMS did not enhance the swallowing function when compared conventional dysphagia rehabilitation. Therefore, the application of 1 Hz rTMS should be reconsidered to improve swallowing function in the chronic period.",2019,"However, a significant improvement was observed on appetite, fear of eating, and mental health parameters of quality of life assessment in the study group compared to the control group (p < 0.05).","['of Post-stroke Patients', 'Twenty-eight patients', 'stroke patients with dysphagia', 'patients with stroke']","['rTMS', 'Repetitive transcranial magnetic stimulation (rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation', '1\xa0Hz rTMS', 'conventional dysphagia rehabilitation']","['demographic and clinical features', 'Swallowing Function and Quality of Life', 'swallowing function and quality of life of mono-hemispheric post', 'appetite, fear of eating, and mental health parameters of quality of life assessment', 'Swallowing function and quality of life', 'swallowing function', 'Swallowing function']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0919597', 'cui_str': 'Phagophobia'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",28.0,0.019462,"However, a significant improvement was observed on appetite, fear of eating, and mental health parameters of quality of life assessment in the study group compared to the control group (p < 0.05).","[{'ForeName': 'Nezehat Özgül', 'Initials': 'NÖ', 'LastName': 'Ünlüer', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara Yıldırım Beyazıt University, 06760, Çubuk, Ankara, Turkey. nunluer80@yahoo.com.'}, {'ForeName': 'Çağrı Mesut', 'Initials': 'ÇM', 'LastName': 'Temuçin', 'Affiliation': 'Faculty of Medicine Neurology Department, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Numan', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Selen', 'Initials': 'S', 'LastName': 'Serel Arslan', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}, {'ForeName': 'Aynur Ayşe', 'Initials': 'AA', 'LastName': 'Karaduman', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Hacettepe University, 06100, Sıhhıye, Ankara, Turkey.'}]",Dysphagia,['10.1007/s00455-018-09965-6']
445,31740727,Comparison of pressure- and volume-controlled ventilation during laparoscopic colectomy in patients with colorectal cancer.,"This study investigated the differences in airway mechanics and postoperative respiratory complications using two mechanical ventilation modalities and the relationship between biomarkers and postoperative respiratory complications in patients with colorectal cancer who underwent laparoscopic colectomy. Forty-six patients with colorectal cancer scheduled for laparoscopic colectomy were randomly allocated to receive mechanical ventilation using either volume-controlled ventilation (VCV) (n = 23) or pressure-controlled ventilation (PCV) (n = 23). Respiratory parameters were measured and plasma sRAGE and S100A12 were collected 20 minutes after the induction of anesthesia in the supine position without pneumoperitoneum (T1), 40 minutes after 30° Trendelenburg position with pneumoperitoneum (T2), at skin closure in the supine position (T3), and 24 hours after the operation (T4). The peak airway pressure (Ppeak) at T2 was lower in the PCV group than in the VCV group. The plateau airway pressures (Pplat) at T2 and T3 were higher in the VCV group than in the PCV group. Plasma levels of sRAGE at T2 and T3 were 1.6- and 1.4-fold higher in the VCV group than in the PCV group, while plasma S100A12 levels were 2.6- and 2.2-fold higher in the VCV group than in the PCV group, respectively. There were significant correlations between Ppeak and sRAGE, and between Ppeak and S100A12. There were also correlations between Pplat and sRAGE, and between Pplat and S100A12. sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications. Postoperative respiratory complications were 3-fold higher in the VCV group than in the PCV group. In conclusion, during laparoscopic colectomy in patients with colorectal cancer, the peak airway pressure, the incidence of postoperative respiratory complications, and plasma sRAGE and S100A12 levels were lower in the PCV group than in the VCV group. Intra- and postoperative plasma sRAGE and S100A12 were useful for predicting the development of postoperative respiratory complications.",2019,sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications.,"['Forty-six patients with colorectal cancer scheduled for laparoscopic colectomy', 'patients with colorectal cancer', 'patients with colorectal cancer who underwent laparoscopic colectomy']","['pressure- and volume-controlled ventilation', 'mechanical ventilation using either volume-controlled ventilation (VCV) (n\u2009=\u200923) or pressure-controlled ventilation (PCV', 'laparoscopic colectomy', 'VCV', 'mechanical ventilation modalities']","['Plasma levels of sRAGE', 'sRAGE and S100A12 levels', 'plasma S100A12 levels', 'peak airway pressure (Ppeak', 'Postoperative respiratory complications', 'plateau airway pressures (Pplat', 'peak airway pressure, the incidence of postoperative respiratory complications, and plasma sRAGE and S100A12 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4019423', 'cui_str': 'ENRAGE Protein'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",46.0,0.0391975,sRAGE and S100A12 levels at T2 and T3 showed high sensitivity and specificity for postoperative respiratory complications.,"[{'ForeName': 'Sangbong', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Division of Respirology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Geun Joo', 'Initials': 'GJ', 'LastName': 'Choi', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Gyu', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea. roman00@naver.com.'}]",Scientific reports,['10.1038/s41598-019-53503-9']
446,31150753,Classifying Mood Symptom Trajectories in Adolescents With Bipolar Disorder.,"OBJECTIVE


The Course and Outcome of Bipolar Youth study found that children and adolescents with bipolar spectrum disorders followed 1 of 4 distinct mood trajectories over 8 years of follow-up, with as many as 25% of participants showing a predominantly euthymic course. We evaluated whether similar patterns of illness course are observed in adolescents with bipolar I and II disorder who participated in a 2-year clinical trial.
METHOD


A total of 144 adolescents with bipolar I or II disorder, identified shortly after a mood episode, were assessed over a 2-year period. Participants were randomly assigned to one of 2 psychosocial family treatments during the first 9 months of the study, and pharmacotherapy was provided throughout the 2 years. Using latent class growth analyses, we classified participants into distinct courses of illness based on mood ratings collected over the 2 years. We examined demographic and illness variables as predictors of these course classifications.
RESULTS


Latent class growth analyses indicated four mood trajectories: ""predominantly euthymic"" (29.9% of sample), ""ill with significantly improving course"" (11.1%), ""moderately euthymic"" (26.4%), and ""ill with moderately improving course"" (32.6%). Adolescents in these classes were euthymic 77.7%, 53.6%, 44.1%, and 18.6% of the weeks of follow-up, respectively. Psychosocial treatment condition and baseline medication exposure were not associated with trajectories. However, youth with more severe baseline depressive symptoms, suicidality, lower quality of life scores, and minority race/ethnicity had more symptomatic courses of illness over time.
CONCLUSION


A substantial proportion (25%-30%) of youth with bipolar I or II disorder maintain euthymic states over extended periods of follow-up. Identifying youth who are more and less likely to remain stable over time may help guide psychosocial and pharmacological treatments after an illness episode.
CLINICAL TRIAL REGISTRATION INFORMATION


Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents; https://clinicaltrials.gov/; NCT00332098.",2020,Psychosocial treatment condition and baseline medication exposure were not associated with trajectories.,"['adolescents with bipolar I and II disorder who participated in a 2-year clinical trial', 'Adolescents with Bipolar Disorder', '144 adolescents with bipolar I or II disorder, identified shortly after a mood episode, were assessed over a 2-year period', 'children and adolescents with bipolar spectrum disorders followed one of four distinct mood trajectories over 8 years of follow-up, with as many as 25% showing a predominantly euthymic course']",[],"['Classifying Mood Symptom Trajectories', 'course', 'severe baseline depressive symptoms, suicidality, lower quality of life scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",144.0,0.119091,Psychosocial treatment condition and baseline medication exposure were not associated with trajectories.,"[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, the University of Colorado, Aurora.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Axelson', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus.""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': 'University of Pittsburgh Medical Center, PA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Kowatch', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.04.028']
447,31109190,Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases.,"Background Conducting randomized controlled trials to investigate survival in a rare disease like pulmonary arterial hypertension has considerable ethical and logistical constraints. In many studies, such as the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) randomized controlled trial, evaluating survival is further complicated by bias introduced by allowing active therapy among placebo-treated patients who clinically deteriorate. Methods and Results SERAPHIN enrolled and followed patients in the same time frame as the US Registry to Evaluate Early And Long-term PAH Disease Management, providing an opportunity to compare observed survival for SERAPHIN patients with predicted survival had they received real-world treatment as in the Registry to Evaluate Early And Long-term PAH Disease Management. From the Registry to Evaluate Early And Long-term PAH Disease Management (N=3515), 734 patients who met SERAPHIN eligibility criteria were selected and their data used to build a prediction model for time to death up to 3 years based on 10 baseline prognostic variables. The model was used to predict a survival curve for each of the 742 SERAPHIN patients via their baseline variables. The average of these predicted survival curves was compared with observed survival of the placebo (n=250) and macitentan 10 mg (n=242) groups using a log-rank test and Cox proportional hazard model. Observed mortality risk for patients randomized to placebo, 62% of whom were taking background pulmonary arterial hypertension therapy, tended to be lower than that predicted for all SERAPHIN patients (16% lower; P=0.259). The observed placebo survival curve closely approximated the predicted survival curve for the first 15 months. Beyond that time, observed risk of mortality decreased compared with predicted mortality, potentially reflecting the impact of crossover of patients in the placebo group to active therapy. Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010). Conclusions These analyses show that, in a rare disease, real-world observational data can complement randomized controlled trial data to overcome some challenges associated with assessing survival in the setting of a randomized controlled trial. Clinical Trial Registration https://www.clinicaltrials.gov . Unique identifiers: NCT00660179 and NCT00370214.",2019,"Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010).","['treated patients who clinically deteriorate', '734 patients who met SERAPHIN eligibility criteria']","['Endothelin Receptor Antagonist', 'placebo']","['mortality risk', 'survival curve', 'risk of mortality']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1134681', 'cui_str': 'Endothelin Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.341133,"Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality ( P=0.010).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': 'Department of Pulmonary Circulation and Thromboembolic Diseases and Cardiology, Centre of Postgraduate Medical Education, European Health Centre, ECZ-Otwock, Poland (A.T.).'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Bacchi', 'Affiliation': 'Biostatistics, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (M.B., B.H.).'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Delcroix', 'Affiliation': 'Department of Pneumology, University Hospitals Leuven, Belgium (M.D.).'}, {'ForeName': 'Harrison W', 'Initials': 'HW', 'LastName': 'Farber', 'Affiliation': 'Pulmonary Center, Boston University School of Medicine, MA (H.W.F.).'}, {'ForeName': 'Hossein-Ardeschir', 'Initials': 'HA', 'LastName': 'Ghofrani', 'Affiliation': 'University of Giessen and Marburg Lung Center, Germany, member of the German Center of Lung Research, and Department of Medicine, Imperial College London, United Kingdom (H.-A.G.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hennessy', 'Affiliation': 'Biostatistics, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (M.B., B.H.).'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Jansa', 'Affiliation': 'Clinicial Department of Cardiology and Angiology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic (P.J.).'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Canada Respirology Division, London Health Sciences Centre, ON (S.M.).'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Perchenet', 'Affiliation': 'Global Medical Affairs, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (L.P.).'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Pulido', 'Affiliation': 'Cardiopulmonary Department, Ignacio Chávez National Heart Institute, Mexico City, Mexico (T.P.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rosenberg', 'Affiliation': 'Epidemiology & Observational Studies, Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (D.R.).'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Rubin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of California, San Diego Medical School (L.J.R.).'}, {'ForeName': 'B K S', 'Initials': 'BKS', 'LastName': 'Sastry', 'Affiliation': 'Division of Cardiology, CARE Hospitals, Hyderabad, India (B.K.S.S.).'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': ""APHP Centre de Référence de l'Hypertension Pulmonaire, Service de Pneumologie et Soins Intensifs, Université Paris-Sud, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France (G.S., O.S.).""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': ""APHP Centre de Référence de l'Hypertension Pulmonaire, Service de Pneumologie et Soins Intensifs, Université Paris-Sud, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France (G.S., O.S.).""}, {'ForeName': 'Rogério', 'Initials': 'R', 'LastName': 'Souza', 'Affiliation': 'INCOR Heart Institute, University of Sao Paulo, Brazil (R.S.).'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Harvard University, Boston, MA (L.-J.W.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Channick', 'Affiliation': 'University of California Los Angeles (R.C.).'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Benza', 'Affiliation': 'Division of Cardiovascular Diseases, Allegheny General Hospital, Pittsburgh, PA (R.B.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.118.005095']
448,30209561,Tongue-Strengthening Exercises in Healthy Older Adults: Does Exercise Load Matter? A Randomized Controlled Trial.,"Tongue-strengthening exercises (TSE) are based on the principles of exercise and motor learning, including intensity. Intensity is manipulated by gradually adjusting the resistive load. This randomized controlled trial (RCT) investigates the effect of three different values resistive load during TSE in healthy older adults. Sixty subjects completed 8 weeks of TSE while exercising with Iowa Oral Performance Instrument (IOPI). They were randomly distributed to 4 different treatment arms: 3 exercise groups (EG1: n = 15; EG2: n = 16, EG3: n = 16) and 1 control group performing lip-strengthening exercises (CG: n = 13). Values of resistive load for EG1, EG2, and EG3 were 100, 80, and 60% 1RM, respectively. Anterior and posterior maximal isometric pressures (MIP A , MIP P ) were measured at baseline, after 4 and 8 weeks of training and 4 weeks post-training. MIP A  and MIP P  in the EG were significantly higher than in the CG at all time points, except baseline. No significant differences between EG were found, but some trends were observable. Anteriorly, the higher the resistive load, the higher the increase in MIP. Posteriorly, 100% 1RM caused the highest values, followed by 60% and 80% 1RM. No detraining effects were measured. The degree of exercise load had a significant negative effect on the registered success rate. This RCT confirms the efficacy of TSE in healthy older adults. For MIP A  and MIP P , TSE at a resistive load of 100% 1RM are the most efficient choice in this population, while lowering the resistive load will lead to an increased success rate. No detraining effects were registered.",2019,"MIP A  and MIP P  in the EG were significantly higher than in the CG at all time points, except baseline.","['Healthy Older Adults', 'Sixty subjects completed 8\xa0weeks of TSE while exercising with Iowa Oral Performance Instrument (IOPI', 'healthy older adults']","['TSE', 'Tongue-strengthening exercises (TSE', '3 exercise groups (EG1: n\u2009=\u200915; EG2: n\u2009=\u200916, EG3: n\u2009=\u200916) and 1 control group performing lip-strengthening exercises (CG: n\u2009=\u200913', 'Tongue-Strengthening Exercises']","['MIP A  and MIP P', 'MIP', 'Values of resistive load for EG1, EG2, and EG3', 'Anterior and posterior maximal isometric pressures (MIP A , MIP P ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0333972', 'cui_str': 'Lipping (morphologic abnormality)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.0658367,"MIP A  and MIP P  in the EG were significantly higher than in the CG at all time points, except baseline.","[{'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Van den Steen', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium. Leen.Van.den.Steen@uza.be.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vanderwegen', 'Affiliation': 'Department of Speech, Language and Audiology, University College Thomas More, Molenstraat 8, 2018, Antwerp, Belgium.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Guns', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Elen', 'Affiliation': 'Department of Speech, Language and Audiology, University College Thomas More, Molenstraat 8, 2018, Antwerp, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Bodt', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Van Nuffelen', 'Affiliation': 'Department of Otolaryngology and Head & Neck Surgery - Rehabilitation Center for Communication Disorders, Antwerp University Hospital, Wilrijkstraat 10, Edegem, 2650, Antwerp, Belgium.'}]",Dysphagia,['10.1007/s00455-018-9940-5']
449,31901648,Coping Power Universal for middle school students: The first efficacy study.,"INTRODUCTION


The present study examined the efficacy of the universal prevention version of the Coping Power Program in reducing behavioral and emotional problems and in promoting prosocial behaviors in middle-school classrooms.
METHODS


The study used a randomized control study design; and the sample included 839 middle-school Italian youths (411 males), attending 40 middle-school classrooms. The students were in seventh or eighth grade, and they had an average age of 13.24 years (SD = .65; range 12-14 years). Ninety students were Africans, the rest were Caucasian. Teachers and parents completed the Strengths and Difficulties Questionnaire, before and after intervention. We used the 24-session universal prevention adaptation of Coping Power, which aims to improve children's emotional regulation and social problem-solving skills.
RESULTS


Linear mixed models and effect sizes indicated that behaviors improved as a result of the Coping Power intervention. Specifically, the program was effective in reducing internalizing problems and increasing prosocial behaviors.
CONCLUSIONS


The Coping Power Universal effectively adapts an existing evidence-based program, and is believed to be a useful strategy also to improve social emotional skills in middle-school students.",2020,"Specifically, the program was effective in reducing internalizing problems and increasing prosocial behaviors.
","['middle-school classrooms', '839 middle-school Italian youths (411 males), attending 40 middle-school classrooms', 'middle school students', 'middle-school students', 'Ninety students were Africans, the rest were Caucasian', 'The students were in seventh or eighth grade, and they had an average age of 13.24 years (SD = .65; range 12-14 years']",['universal prevention version of the Coping Power Program'],"['internalizing problems and increasing prosocial behaviors', 'prosocial behaviors', 'behavioral and emotional problems', 'social emotional skills']","[{'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205441', 'cui_str': 'Seventh (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",411.0,0.0221636,"Specifically, the program was effective in reducing internalizing problems and increasing prosocial behaviors.
","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Muratori', 'Affiliation': 'IRCCS Fondazione Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Pisa, Italy. Electronic address: pmuratori@fsm.unipi.it.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Bertacchi', 'Affiliation': 'Associazione Mente Cognitiva, Lucca, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Catone', 'Affiliation': 'Department of Educational, Psychological and Communication Sciences, Suor Orsola Benincasa University, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mannucci', 'Affiliation': 'IRCCS Fondazione Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Pisa, Italy.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Nocentini', 'Affiliation': 'Department of Sciences of Education and Psychology, University of Florence, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pisano', 'Affiliation': 'Department of Neuroscience, AORN Santobono-Pausilipon, Naples, Italy; Department of Translational Medical Sciences, Federico II University, Naples, Italy.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lochman', 'Affiliation': 'The University of Alabama, Tuscaloosa, AL, USA.'}]",Journal of adolescence,['10.1016/j.adolescence.2019.12.014']
450,29673306,Depressive Symptoms Moderate Dating Violence Prevention Outcomes Among Adolescent Girls.,"PURPOSE


Few dating violence prevention programs assess how variations in initial violence risk affects responsiveness. This study examines the efficacy of Date SMART, a dating violence and sexual risk prevention program designed to target high-risk adolescent girls, in preventing dating violence in the context of varying initial levels of depressive symptoms.
METHOD


A diverse sample of N = 109 female adolescents with a history of physical dating violence participated in a randomized controlled trial of the Date SMART program and a knowledge only (KO) comparison.
RESULTS


Using baseline depression level as a primary risk factor, a series of multilevel models revealed significant main effects of baseline depression such that higher baseline depression was associated with greater physical dating violence perpetration and victimization. Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration. Specifically, those with higher baseline depression in Date SMART showed significantly less physical dating violence perpetration at follow-ups compared with those with higher baseline depression in the KO group. This difference in violence reduction between conditions was not observed for those with lower baseline depression.
DISCUSSION


Date SMART appears to effectively reduce physical dating violence perpetration in those with higher levels of initial risk. Current findings support that adolescents with different risk profiles respond differently to violence prevention programs.",2018,"Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration.","['Adolescent Girls', 'A diverse sample of N = 109 female adolescents with a history of physical dating violence', 'risk adolescent girls']",['Date SMART program and a knowledge only (KO) comparison'],"['Depressive Symptoms Moderate Dating Violence Prevention Outcomes', 'assessment point, depressive symptoms, and condition for physical dating violence perpetration', 'physical dating violence perpetration', 'baseline depression', 'violence reduction']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",109.0,0.0234464,"Results also showed a three-way interaction for assessment point, depressive symptoms, and condition for physical dating violence perpetration.","[{'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Collibee', 'Affiliation': '1 Brown University, Providence, RI, USA.'}, {'ForeName': 'Christie J', 'Initials': 'CJ', 'LastName': 'Rizzo', 'Affiliation': '3 Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemp', 'Affiliation': '1 Brown University, Providence, RI, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hood', 'Affiliation': '3 Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Doucette', 'Affiliation': '3 Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Gittins Stone', 'Affiliation': '3 Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'DeJesus', 'Affiliation': '2 Rhode Island Hospital, Providence, RI, USA.'}]",Journal of interpersonal violence,['10.1177/0886260518770189']
451,31985080,Effect of Timing of Intravenous Fentanyl Administration on the Incidence of Posttonsillectomy Nausea and Vomiting.,"OBJECTIVE/HYPOTHESIS


Fentanyl is commonly administered toward the end of tonsillectomy to prevent emergence delirium and reduce postoperative pain. However, it can delay emergence from anesthesia and increase the risk of postoperative nausea and vomiting (PONV). The goal of our study was to compare the risk of PONV based on the timing of fentanyl administration at the end of tonsillectomy in children.
STUDY DESIGN


Prospective, double-blind, randomized controlled trial.
METHODS


One hundred forty patients aged 3 to 7 years undergoing tonsillectomy were divided into two groups. Fentanyl (1 μg/kg) was administered at the end of surgery in group 1 (n = 70) and at 10 to 15 minutes before the end of surgery in group 2 (n = 70). Time to regular breathing and time to emergence from anesthesia were measured from the end of surgery. PONV and pediatric anesthesia emergence delirium scale scores were assessed every 10 minutes after admission to the postanesthesia care unit.
RESULTS


Incidences of PONV (2.9% vs. 2.9%, P > .99) and emergence delirium (11.4% vs. 5.7%, P = .23) were not significantly different between the two groups. Time to regular breathing (mean difference = 2.3 minutes; 95% confidence interval [CI]: 0.9 to 3.7 minutes) and time to emergence (median difference = 6.5 minutes; 95% CI, 2.5 to 10.5 minutes) were significantly longer in group 1 than in group 2.
CONCLUSIONS


Although there was no beneficial effect on PONV, recovery of regular breathing and consciousness was quicker with earlier fentanyl administration. Emergence delirium was well-controlled, similar to that with fentanyl administration at the end of surgery.
LEVEL OF EVIDENCE


1b Laryngoscope, 2020.",2020,"Although there was no beneficial effect on PONV, recovery of regular breathing and consciousness was quicker with earlier fentanyl administration.","['children', 'One hundred forty patients aged 3 to 7\u2009years undergoing tonsillectomy']","['Fentanyl', 'Intravenous Fentanyl']","['PONV and pediatric anesthesia emergence delirium scale scores', 'risk of postoperative nausea and vomiting (PONV', 'Posttonsillectomy Nausea and Vomiting', 'Time to regular breathing and time to emergence from anesthesia', 'Time to regular breathing', 'PONV', 'PONV, recovery of regular breathing and consciousness', 'Emergence delirium', 'emergence delirium']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C1301785', 'cui_str': 'Emergence from anesthesia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",140.0,0.284084,"Although there was no beneficial effect on PONV, recovery of regular breathing and consciousness was quicker with earlier fentanyl administration.","[{'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min-Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ha Yan', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Wyun Kon', 'Initials': 'WK', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sungmi', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Joo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",The Laryngoscope,['10.1002/lary.28533']
452,31829510,Improvement of skin texture and wrinkles using radiofrequency ultra-thin electrode technology.,"BACKGROUND


Application of radiofrequency (RF) energy with microneedles to facial skin shown to promote skin renewal.
AIM


To evaluate the safety and efficacy of the VoluDerm technology with 100 ultra-thin electrodes gen100 tip for improvement of skin texture and wrinkles.
METHODS


A prospective, open-label, intra-individual-controlled trial. Twelve subjects (mean age, 45.5; Fitzpatrick skin types II-III) with Fitzpatrick Elastosis Scale (FES) score 3-6 were treated with VoluDerm RF technology using the gen100 ultra-thin electrodes disposable tip. The participants underwent three treatments at 3-week intervals. Treatment safety was evaluated at each treatment visit and at the follow-up visits (1 and 3 months post last treatment). Efficacy of treatment evaluated at 1 and 3 months after the last treatment using the FES as well as evaluator- and subject-rated Global Aesthetic Improvement Scale (GAIS).
RESULTS


Treatment was well tolerated, with no downtime or adverse events. One and three months after the last treatment session, physician-rated FES showed statistically significant improvement of 2.67 ± 1.18 and 2.33 ± 1.03, respectively (P < .0001), from baseline (4.83 ± 0.69). According to the investigator assessment of improvement using the GAIS scale, all subjects had an improvement in skin texture and pigmentation and most of the patients (91.7%) had an improvement in skin brightness, tightness, and wrinkles.
CONCLUSION


This is the first study evaluating the Legend+ RF System with VoluDerm technology using the novel gen100 ultra-thin electrodes tip. This study demonstrated effective and well-tolerated treatment for improving skin texture and appearance with minimal to no downtime.",2020,"According to the investigator assessment of improvement using the GAIS scale, all subjects had an improvement in skin texture and pigmentation and most of the patients (91.7%) had an improvement in skin brightness, tightness, and wrinkles.
","['Twelve subjects (mean age, 45.5; Fitzpatrick skin types II-III) with Fitzpatrick Elastosis Scale (FES) score 3-6 were treated with']","['radiofrequency ultra-thin electrode technology', 'VoluDerm RF technology using the gen100 ultra-thin electrodes disposable tip']","['skin brightness, tightness, and wrinkles', 'skin texture and wrinkles', 'safety and efficacy', 'skin texture and pigmentation', 'evaluator- and subject-rated Global Aesthetic Improvement Scale (GAIS', 'tolerated, with no downtime or adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0333448', 'cui_str': 'Elastoid degeneration (morphologic abnormality)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0423752', 'cui_str': 'Skin texture (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",12.0,0.0122479,"According to the investigator assessment of improvement using the GAIS scale, all subjects had an improvement in skin texture and pigmentation and most of the patients (91.7%) had an improvement in skin brightness, tightness, and wrinkles.
","[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gold', 'Affiliation': 'Tennessee Clinical Research Center, Nashville, TN, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Biron', 'Affiliation': 'Tennessee Clinical Research Center, Nashville, TN, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Tennessee Clinical Research Center, Nashville, TN, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13239']
453,31984762,Effect of telephone calls from a centralized coordinating center on participant retention in a randomized clinical trial.,"BACKGROUND/AIMS


In clinical trials, participant retention is critical to reduce bias and maintain statistical power for hypothesis testing. Within a multi-center clinical trial of diabetic retinopathy, we investigated whether regular phone calls to participants from the coordinating center improved long-term participant retention.
METHODS


Among 305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants were randomly assigned to receive phone calls at baseline, 6 months, and annually through 3 years (annual contact group) while 153 participants were assigned to receive a phone call at baseline only (baseline contact group). All participants could be contacted if visits were missed. The main outcomes were visit completion, excluding deaths, at 2 years (the primary outcome time point) and at 5 years (the final time point).
RESULTS


At baseline, 77% (117 of 152) of participants in the annual contact group and 76% (116 of 153) in the baseline contact group were successfully contacted. Among participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125) were contacted successfully by telephone around the time of the 1-, 2-, and 3-year visits, respectively. In the annual and baseline contact groups, completion rates for the 2-year primary outcome visit were 88% (129 of 147) versus 87% (125 of 144), respectively, with a risk ratio of 1.01 (95% confidence interval: 0.93-1.10,  p  = .81). At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93). At 2 years, the completion rate of participants successfully contacted at baseline was 89% (202 of 226) versus 80% (52 of 65) among those not contacted successfully (risk ratio = 1.12, 95% confidence interval = 0.98-1.27,  p  = .09); at 5 years, the completion percentages by baseline contact success were 69% (148 of 213) versus 56% (36 of 64; risk ratio = 1.24, 95% confidence interval = 0.98-1.56,  p  = .08).
CONCLUSION


Regular phone calls from the coordinating center to participants during follow-up in this randomized clinical trial did not improve long-term participant retention.",2020,"At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93).","['305 adults in the Diabetic Retinopathy Clinical Research Retina Network Protocol S randomized trial, 152 participants', 'participants in the annual contact group active at each annual visit (i.e. not dropped from the study or deceased), 85% (125 of 147), 79% (108 of 136), and 88% (110 of 125']",['telephone calls'],"['visit completion, excluding deaths', 'completion rates', 'completion rate']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",152.0,0.554304,"At 5 years, the final study visit, participant completion rates were 67% (96 of 144) versus 66% (88 of 133) with a risk ratio of 1.01 (95% confidence interval = 0.85-1.19,  p  = .93).","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leanne T', 'Initials': 'LT', 'LastName': 'Labriola', 'Affiliation': 'Department of Ophthalmology, Carle Foundation Hospital, College of Medicine, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Oliver', 'Affiliation': 'Southeastern Retina Associates, Knoxville, TN, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774519894229']
454,31939511,VIRTUAL LEARNING ENVIRONMENT IN PEDIATRIC RHEUMATOLOGY FOR PEDIATRIC RESIDENTS.,"OBJECTIVE


To develop, implement and evaluate an online virtual learning environment (VLE) on pediatric rheumatology, aimed at pediatric residents, analyzing its effectiveness and satisfaction rates.
METHODS


A total of 92 first and second year pediatric residents at two pediatric reference centers were invited to participate in the study. Residents were randomized into a case group (that answered the pre-course test, attended the six virtual pediatric rheumatology modules, and then responded to the post-course test and a satisfaction questionnaire) and a control group (that only answered the pre-course test and, after 4 weeks, the post-course test).
RESULTS


Forty-seven residents (51%) completed their participation. In the case group (n=24), the mean percentage of correct answers was 14% higher on the post-course test (p<0.001). The number of correct answers was larger in the case group than in the control one (n=23) in the post-course test (p=0.045). In the assessment of satisfaction with VLE use, residents considered the site easy to navigate (91%), suitable as a learning tool (91%), and attractive in design (79%). They reported poor prior knowledge in pediatric rheumatology (91%) and agreed that there was good learning with the methodology (75%).
CONCLUSIONS


The virtual learning environment in pediatric rheumatology proved to be an effective teaching tool with high satisfaction rates, providing pediatrician residents with adequate knowledge regarding the initial assessment and management of children with rheumatic diseases.",2020,"The virtual learning environment in pediatric rheumatology proved to be an effective teaching tool with high satisfaction rates, providing pediatrician residents with adequate knowledge regarding the initial assessment and management of children with rheumatic diseases.","['children with rheumatic diseases', 'Forty-seven residents (51%) completed their participation', 'A total of 92 first and second year pediatric residents at two pediatric reference centers were invited to participate in the study']",['online virtual learning environment (VLE'],"['mean percentage of correct answers', 'number of correct answers']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",47.0,0.017834,"The virtual learning environment in pediatric rheumatology proved to be an effective teaching tool with high satisfaction rates, providing pediatrician residents with adequate knowledge regarding the initial assessment and management of children with rheumatic diseases.","[{'ForeName': 'Ana Luiza Garcia', 'Initials': 'ALG', 'LastName': 'Cunha', 'Affiliation': 'Fundação Hospitalar do Estado de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Terreri', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Claudio Arnaldo', 'Initials': 'CA', 'LastName': 'Len', 'Affiliation': 'Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo,['10.1590/1984-0462/2020/38/2018189']
455,31939515,HOW CAN NEW TECHNOLOGIES HELP REDUCE ABSENTEEISM IN PEDIATRIC CONSULTATION?,"OBJECTIVE


To identify the most effective form of contact, as a possible intervention to reduce absenteeism in consultations of children with suspected or confirmed pulmonary tuberculosis.
METHODS


A randomized clinical trial was conducted with prospective data collection, between March 2017 and February 2018. Patients were randomized into three groups to be reminded about the appointment: telephone contact, SMS or WhatsApp, or no intervention. A convenience sample was obtained, with a significance level of 5%.
RESULTS


78 children were included, with a median age of four years old (zero to 14); 59.0% of them were in treatment for a latent infection and 6.4% had active tuberculosis. Among the 78 children, 74.4% lived in Curitiba (Sourhern Brazil); 62.8% lived with both parents; 38.5% of the parents had formal employment and 47.4% of the mothers were housewives; 50.8% of the fathers and 55.7% of the mothers had more than nine years of schooling. In 78.2% of the families, per capita income was up to 0.5 minimum wages; 27.3% were enrolled in social programs; 28.2% lived in homes provided by the government. There was a total of 238 interventions made: 85 (35.7%) by telephone contact, 78 (32.8%) by text message (WhatsApp was 97.2% of these) and 75 (31.5%) had no further contact. There was no statistical difference among the sociodemographic and cultural characteristics studied. The absenteeism rate was 24.0% and the abandonment rate was 16.7%. Giving a reminder to the patient's guardian prior to the consultation, regardless of the intervention (p=0.021) and specifically by WhatsApp message (p=0.032) was associated with no absenteeism, though it was not associated with abandonment of the treatment.
CONCLUSIONS


Using new tools, such as WhatsApp, to remind guardians of appointments reduces absenteeism. Consequently, it may lead to a reduction in abandoning treatment and it may improvetreatment outcome of children with a tuberculosis infection or disease.",2020,"There was a total of 238 interventions made: 85 (35.7%) by telephone contact, 78 (32.8%) by text message (WhatsApp was 97.2% of these) and 75 (31.5%) had no further contact.","['78 children were included, with a median age of four years old (zero to 14); 59.0% of them were in treatment for a latent infection and 6.4% had active tuberculosis', 'children with suspected or confirmed pulmonary tuberculosis', 'prospective data collection, between March 2017 and February 2018', 'children with a tuberculosis infection or disease', '78 children, 74.4% lived in Curitiba (Sourhern Brazil); 62.8% lived with both parents']","['telephone contact, SMS or WhatsApp, or no intervention']","['abandonment rate', 'absenteeism rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0151332', 'cui_str': 'Active tuberculosis (disorder)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1634625', 'cui_str': 'Percent live'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0000849', 'cui_str': 'Absenteeism'}]",78.0,0.0327984,"There was a total of 238 interventions made: 85 (35.7%) by telephone contact, 78 (32.8%) by text message (WhatsApp was 97.2% of these) and 75 (31.5%) had no further contact.","[{'ForeName': 'Neliane da Silva', 'Initials': 'NDS', 'LastName': 'Bueno', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Andrea Maciel de Oliveira', 'Initials': 'AMO', 'LastName': 'Rossoni', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Elisângela Aparecida da Silva', 'Initials': 'EADS', 'LastName': 'Lizzi', 'Affiliation': 'Universidade Tecnológica Federal do Paraná, Cornélio Procópio, PR, Brazil.'}, {'ForeName': 'Tony Tanous', 'Initials': 'TT', 'LastName': 'Tahan', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Tatiane Emi', 'Initials': 'TE', 'LastName': 'Hirose', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, PR, Brazil.'}, {'ForeName': 'Herberto José', 'Initials': 'HJ', 'LastName': 'Chong Neto', 'Affiliation': 'Universidade Federal do Paraná, Curitiba, PR, Brazil.'}]",Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo,['10.1590/1984-0462/2020/38/2018313']
456,31975288,A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study.,"BACKGROUND


Osteoarthritis is a prevalent condition in older adults that causes many patients to require a hip or knee replacement. Reducing patients' sedentariness prior to surgery may improve physical function and post-operative outcomes.
METHODS


We conducted a pragmatic randomised-controlled feasibility study with 2:1 allocation into intervention or usual care groups. The intervention, based on Self-Determination Theory, involved techniques to reduce sedentary behaviour, including motivational interviewing, setting of behavioural goals, and more. The primary outcome was feasibility, assessed using mixed methods. We included exploratory measures to inform a future definitive trial, such as ActivPal3 accelerometry to measure movement, the Short Physical Performance Battery (SPPB), Basic Psychological Needs, and cardiometabolic biomarkers. Assessments were at baseline, 1-week pre-surgery, and 6-week post-surgery.
RESULTS


We recruited 35 participants aged ≥ 60 years approximately 8 weeks before hip or knee arthroplasty. Participant uptake rate was 14.2%, and retention rate 85.7%. Participants were very satisfied with the study which was found to be feasible with some modifications. Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d -1 .
CONCLUSION


In this older surgical population, it is feasible to use behavioural techniques to displace sedentary time to activity and to conduct a trial spanning the period of surgical intervention. This may improve physical function and surgical outcomes. The INTEREST intervention is now ready for evaluation in a full-scale randomised-controlled trial.
REGISTRATION


This trial was registered on Clinicaltrials.gov on 13/11/2018. ID: NCT03740412.",2020,"Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d -1 .
CONCLUSION


","['60\xa0years approximately 8\xa0weeks before hip or knee arthroplasty', '35 participants aged\u2009≥', 'older adults', 'older adults undergoing orthopaedic surgery (INTEREST']",['ID'],"['SPPB', 'Short Physical Performance Battery (SPPB), Basic Psychological Needs, and cardiometabolic biomarkers', 'Participant uptake rate', 'sedentary time']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",35.0,0.12182,"Exploratory within-group comparisons found that the intervention has potential to improve SPPB by 0.71 points from baseline to pre-surgery, a clinically significant increase, and reduce sedentary time by up to 66 min d -1 .
CONCLUSION


","[{'ForeName': 'Justin Avery', 'Initials': 'JA', 'LastName': 'Aunger', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK. j.aunger@bham.ac.uk.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Davis', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Evans Atiah', 'Initials': 'EA', 'LastName': 'Asamane', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Carolyn Anne', 'Initials': 'CA', 'LastName': 'Greig', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01475-6']
457,31948455,"Effect of switching administration of alendronate after teriparatide for the prevention of BMD loss around the implant after total hip arthroplasty, 2-year follow-up: a randomized controlled trial.","BACKGROUND


Stress shielding after total hip arthroplasty (THA) can induce bone mineral density (BMD) loss around the femoral implant. Several studies using drug have described methods to prevent BMD loss around implants following THA. Switching from teriparatide to alendronate was reported to increase lumbar BMD; on the other hands, it is unclear whether switching from teriparatide to alendronate is effective around the implant. The aim of this study is that changes in BMD is compared in patients switched from teriparatide to alendronate, in patients treated with alendronate alone, and in control patients without medication after total hip arthroplasty.
PATIENTS AND METHODS


Patients were randomized into three groups, those switched to alendronate after teriparatide (switch: n = 17), those receiving continuous alendronate (ALD: n = 15), and control untreated patients (control: n = 16) and followed up for 2 years after THA. Baseline periprosthetic BMD was measured by dual-energy X-ray absorptiometry (DEXA) 1 week after THA, followed by subsequent measurements at 1 and 2 years postoperatively. Lumbar BMD was also evaluated at preoperatively, 1 and 2 years postoperatively.
RESULTS


Two years after surgery, BMD (%) at zone 1 was significantly higher in the switch group than in the control group (P = 0.02). BMD (%) at zone 7 was significantly higher in the switch and ALD groups than in the control group (P = 0.01, P = 0.03). Lumbar BMD (%) anterior-posterior (AP) side was significantly higher in the switch group than in the ALD and control groups 2 years after surgery. On the other hand, lumbar BMD (%) lateral side was significantly higher in the switch and ALD groups than control group 2 years after surgery.
CONCLUSIONS


Switching therapy had a significant effect on BMD of the lumbar spine and zones 1 and 7 at 2 years postoperatively. At zone 1 in particular, it was found to be more effective than ALD alone.
TRIAL REGISTRATION


UMIN, registry number UMIN000016158. Registered 8 January 2015.",2020,Lumbar BMD (%) anterior-posterior (AP) side was significantly higher in the switch group than in the ALD and control groups 2 years after surgery.,['Patients'],"['teriparatide to alendronate', 'teriparatide', 'alendronate alone', 'continuous alendronate (ALD', 'alendronate', 'alendronate after teriparatide', 'Stress shielding after total hip arthroplasty (THA']","['lumbar BMD', 'BMD loss', 'bone mineral density (BMD) loss', 'BMD', 'BMD of the lumbar spine', 'Lumbar BMD (%) anterior-posterior (AP) side', 'Lumbar BMD', 'lumbar BMD (%) lateral side', 'Baseline periprosthetic BMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0330318', 'cui_str': 'Alder'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]",,0.0427697,Lumbar BMD (%) anterior-posterior (AP) side was significantly higher in the switch group than in the ALD and control groups 2 years after surgery.,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan. naomik58@aol.com.'}, {'ForeName': 'Hyonmin', 'Initials': 'H', 'LastName': 'Choe', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ike', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Tezuka', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Higashihira', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-1547-5']
458,31948466,Impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults: Study protocol for a randomized controlled single-center trial.,"BACKGROUND


This trial addresses the global problem of chronic venous leg ulcers (CVLUs), wounds that cause significant infirmity for an estimated 9.7 million people annually, mainly older adults with comorbidities. Advanced therapies are needed because standard topical therapies are often ineffective or yield only short-term wound healing. Thus, we are testing a new oral therapy containing the bioactive elements of fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), for targeting and reducing the high numbers of activated polymorphonuclear leukocytes (PMN) in wound microenvironments that keep CVLUs ""trapped"" in a chronic inflammatory state.
METHODS


This double-blind RCT will include 248 eligible adults ≥ 55 years of age with CVLUs receiving standard care at a large Midwest outpatient wound clinic. Participants are randomized to two groups: 12 weeks of daily oral therapy with EPA + DHA (1.87 g/day of EPA + 1.0 g/day of DHA) or daily oral therapy with placebo. At 0, 4, 8, and 12 weeks, across the two groups, we are pursuing three specific aims: Aim 1. Compare levels of EPA + DHA-derived lipid mediators, and inflammatory cytokines in blood and wound fluid; Subaim 1a. Compare inflammatory cytokine gene expression by PMNs in blood; Aim 2. Compare PMN activation in blood and wound fluid, and PMN-derived protease levels in wound fluid; Aim 3. Compare reduction in wound area, controlling for factors known to impact healing, and determine relationships with lipid mediators, cytokines, and PMN activation. Subaim 3a. Compare frequency of CVLU recurrence and levels of study variables in blood between the randomly assigned two subgroups (continuing EPA + DHA therapy versus placebo therapy beyond week 12) within the EPA + DHA group with healed CVLUs after 3 months of therapy. Subaim 3b. Compare symptoms of pain at all time points and quality of life at first and last time points across the two groups and two subgroups.
DISCUSSION


This trial will provide new evidence about the effectiveness of EPA + DHA oral therapy to target and reduce excessive PMN activation systemically and locally in patients with CVLUs. If effective, this therapy may facilitate healing and thus be a new adjunct treatment for CVLUs in the aging population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03576989; Registered on 13 June 2018.",2020,"At 0, 4, 8, and 12 weeks, across the two groups","['patients with CVLUs', 'older adults with comorbidities', '248 eligible adults ≥ 55\u2009years of age with CVLUs receiving standard care at a large Midwest outpatient wound clinic', 'older adults']","['eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'omega-3 fatty acid oral therapy', 'EPA\u2009+\u2009DHA therapy versus placebo', 'daily oral therapy with EPA\u2009+\u2009DHA (1.87\u2009g/day of EPA\u2009+\u20091.0\u2009g/day of DHA) or daily oral therapy with placebo']","['healing of chronic venous leg ulcers', 'symptoms of pain at all time points and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034380'}]",248.0,0.205265,"At 0, 4, 8, and 12 weeks, across the two groups","[{'ForeName': 'Jodi C', 'Initials': 'JC', 'LastName': 'McDaniel', 'Affiliation': 'College of Nursing, The Ohio State University, 372 Newton Hall, 1585 Neil Avenue, Columbus, OH, 43210-1289, USA. mcdaniel.561@osu.edu.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': 'College of Nursing, The Ohio State University, 372 Newton Hall, 1585 Neil Avenue, Columbus, OH, 43210-1289, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'College of Nursing, The Ohio State University, 372 Newton Hall, 1585 Neil Avenue, Columbus, OH, 43210-1289, USA.'}]",Trials,['10.1186/s13063-019-3970-7']
459,29860057,"Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial.","BACKGROUND


Previous studies have suggested that varenicline, an α4β2 nicotinic receptor partial agonist, and α7 nicotinic receptor full agonist, may be effective for the treatment of methamphetamine (MA) dependence due to dopaminergic effects, relief of glutamatergic and cognitive dysfunction, and activation of nicotinic cholinergic systems. This study aimed to determine if varenicline (1 mg BID) resulted in reduced methamphetamine use compared to placebo among treatment-seeking MA-dependent volunteers.
METHODS


Treatment-seeking MA-dependent volunteers were randomized to varenicline 1 mg twice daily (n = 27) or placebo (n = 25) and cognitive behavioral therapy for 9 weeks. The primary outcomes were the proportion of participants achieving end-of-treatment-abstinence (EOTA, MA-negative urine specimens during weeks 8 and 9) and the treatment effectiveness score (TES, number of MA-negative urine specimens) for varenicline versus placebo.
RESULTS


There was no significant difference in EOTA between varenicline (15%, 4/27) and placebo (20%, 5/25; p = 0.9). There was some suggestion that urinary confirmed medication compliance corresponded with EOTA in the varenicline condition, though it did not reach statistical significance, OR = 1.57 for a 100 ng/ml increase in urine varenicline, p = 0.10, 95% CI (0.99, 3.02). There was no significant difference in mean TES in the varenicline condition (8.6) compared to the placebo condition (8.1), and treatment condition was not a statistically significant predictor of TES, IRR = 1.01, p = 0.9, 95% CI (0.39, 2.70).
CONCLUSIONS


The results of this study indicate that 1 mg varenicline BID was not an effective treatment for MA dependence among treatment-seeking MA-dependent volunteers.",2018,"There was no significant difference in mean TES in the varenicline condition (8.6) compared to the placebo condition (8.1), and treatment condition was not a statistically significant predictor of TES, IRR = 1.01, p = 0.9, 95% CI (0.39, 2.70).
","['methamphetamine dependence', 'Treatment-seeking MA-dependent volunteers', 'treatment-seeking MA-dependent volunteers']","['Varenicline', 'placebo', 'varenicline', 'cognitive behavioral therapy', 'varenicline 1\u202fmg twice daily (n\u202f=\u202f27) or placebo', 'varenicline BID']","['treatment effectiveness score (TES, number of MA-negative urine specimens', 'mean TES', 'medication compliance', 'proportion of participants achieving end-of-treatment-abstinence (EOTA, MA-negative urine specimens']","[{'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1712046', 'cui_str': 'varenicline 1 MG [Chantix]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3489773', 'cui_str': 'Medication Non-Compliance'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.22569,"There was no significant difference in mean TES in the varenicline condition (8.6) compared to the placebo condition (8.1), and treatment condition was not a statistically significant predictor of TES, IRR = 1.01, p = 0.9, 95% CI (0.39, 2.70).
","[{'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Briones', 'Affiliation': 'Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: Mbriones@mednet.ucla.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Shoptaw', 'Affiliation': 'Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Cook', 'Affiliation': 'Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Worley', 'Affiliation': 'Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Aimee-Noelle', 'Initials': 'AN', 'LastName': 'Swanson', 'Affiliation': 'Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Moody', 'Affiliation': 'Center for Human Toxicology, Department of Pharmacology and Toxicology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Wenfang B', 'Initials': 'WB', 'LastName': 'Fang', 'Affiliation': 'Center for Human Toxicology, Department of Pharmacology and Toxicology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tsuang', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Furst', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Heinzerling', 'Affiliation': 'Department of Family Medicine, University of California, Los Angeles, Los Angeles, CA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.04.023']
460,31980242,"A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients.","OBJECTIVE


The aim of our prospective, single-center, randomized study was to compare the procedural outcomes and complication rates of ultrasound (US)-guided common femoral artery (CFA) access to fluoroscopic guidance in noncardiac procedures.
METHODS


A total of 635 patients undergoing femoral access for noncardiac diagnostic or interventional procedures were randomized 1:1 to receive either fluoroscopic or US-guided access. The primary end point of the study was successful CFA cannulation. Secondary end points included the first-pass success rate, time to sheath insertion, and accidental venipunctures rate. Both short (24 hours) and midterm (30-90 days postprocedure) access complications were assessed by practitioners blinded to patient randomization.
RESULTS


Successful CFA cannulation occurred in 93% of US-guided procedures compared with 86% of fluoroscopy-guided access (P = .002). US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy. Rates of complications did not differ at 24 hours (1% vs 1%; P = .99) or 30 to 90 days (2% vs 4%; P = .15) in fluoroscopy vs US-guided access. When access was performed by vascular surgery trainees (residents and fellows), US guidance retained superior rates of successful CFA cannulation compared to fluoroscopy guided access (n = 298; 96% vs 89%; P = .03). Trainees' time to achieve CFA cannulation was similar to attendings' when using US guidance (median, 85 vs 77 seconds; P = .14); however, with fluoroscopy, trainees' times were significantly longer than those of attendings (137 vs 86 seconds; P = .001).
CONCLUSIONS


In comparison to fluoroscopy, US-guided CFA cannulation had a higher rate of success, faster cannulation, and fewer venipunctures in the absence of increased complications.",2020,"US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy.","['noncardiac vascular patients', '635 patients undergoing femoral access for noncardiac diagnostic or interventional procedures']","['ultrasound versus fluoroscopic guided femoral arterial access', 'fluoroscopic or US-guided access', 'fluoroscopy, US-guided CFA cannulation', 'ultrasound (US)-guided common femoral artery (CFA']","['inadvertent venipunctures', 'procedural outcomes and complication rates', 'first-pass success rate, time to sheath insertion, and accidental venipunctures rate', 'access complications', 'successful CFA cannulation', 'Successful CFA cannulation', 'median time to cannulation', 'Rates of complications', 'rates of first-attempt success', ""Trainees' time to achieve CFA cannulation"", 'rate of success, faster cannulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0447105', 'cui_str': 'Common femoral artery (body structure)'}]","[{'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",635.0,0.150195,"US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stone', 'Affiliation': 'Division of Vascular Surgery, Vanderbilt University, Nashville, Tenn; Division of Vascular Surgery, West Virginia University (Charleston Division), Charleston, WV. Electronic address: pstone0627@yahoo.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Division of Vascular Surgery, West Virginia University (Charleston Division), Charleston, WV.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'Charleston Area Medical Center Health Education and Research Institute, Charleston, WV.'}, {'ForeName': 'Jerri', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Charleston Area Medical Center Health Education and Research Institute, Charleston, WV.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.09.051']
461,31941483,"Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination for the treatment of knee osteoarthritis: study protocol for a first-in-man randomized controlled trial.","BACKGROUND


Human adipose-derived Mesenchymal stem cells (HADMSCs) have proven their efficacy in treating osteoarthritis (OA), in earlier preclinical and clinical studies. As the tissue repairers are under the control of mechanical and biochemical signals, improving regeneration outcomes using such signals has of late been the focus of attention. Among mechanical stimuli, low-intensity pulsed ultrasound (LIPUS) has recently shown promise both in vitro and in vivo. This study will investigate the potential of LIPUS in enhancing the regeneration process of an osteoarthritic knee joint.
METHODS


This study involves a prospective, randomized, placebo-controlled, and single-blind trial based on the SPIRIT guidelines, and aims to recruit 96 patients initially diagnosed with knee osteoarthritis, following American College of Rheumatology criteria. Patients will be randomized in a 1:1:1 ratio to receive Intraarticular HADMSCs injection with LIPUS, Intraarticular HADMSCs injection with shame LIPUS, or Normal saline with LIPUS. The primary outcome is Western Ontario and McMaster Universities Index of OA (WOMAC) score, while the secondary outcomes will be other knee structural changes, and lower limb muscle strength such as the knee cartilage thickness measured by MRI. Blinded assessments will be performed at baseline (1 month prior to treatment), 1 month, 3 months, and 6 months following the interventions.
DISCUSSION


This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients. The results may provide evidence of the effectiveness of LIPUS in improving stem cell therapy and deliver valuable information for the design of subsequent trials.
TRIAL REGISTRATION


This study had been prospectively registered with the Chinese Clinical Trials Registry. registration number: ChiCTR1900025907 at September 14, 2019.",2020,This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients.,"['96 patients initially diagnosed with knee osteoarthritis, following American College of Rheumatology criteria', 'OA patients']","['placebo', 'Human adipose-derived Mesenchymal stem cells (HADMSCs', 'Intraarticular HADMSCs injection with LIPUS, Intraarticular HADMSCs injection with shame LIPUS, or Normal saline with LIPUS', 'mechanical stimuli, low-intensity pulsed ultrasound (LIPUS', 'Human adipose-derived Mesenchymal stem cells, low-intensity pulsed ultrasound, or their combination', 'LIPUS']","['knee structural changes, and lower limb muscle strength such as the knee cartilage thickness measured by MRI', 'Western Ontario and McMaster Universities Index of OA (WOMAC) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4704950', 'cui_str': 'Adipose Tissue-Derived Mesenchymal Stromal Cells'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4042796', 'cui_str': 'Low Intensity Pulsed Ultrasound'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.180241,This trial will be the first clinical study to comprehensively investigate the safety and efficacy of LIPUS on stem cell therapy in OA patients.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasb', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Liangjiang', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Chenzi', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hong', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China. chenhong1129@hotmail.com.""}]",BMC musculoskeletal disorders,['10.1186/s12891-020-3056-4']
462,31241854,Treatment of atrophic acne scars using autologous platelet-rich plasma vs combined subcision and autologous platelet-rich plasma: A split-face comparative study.,"BACKGROUND


Multiple therapeutic approaches are usually required when treating atrophic acne scars. Subcision was reported to be of value in improving rolling scars. Autologous platelet-rich plasma (PRP) has recently been proposed as an adjuvant treatment option for atrophic acne scars with few reports evaluating its efficacy.
OBJECTIVE


Our objective was to compare the effect of intradermal injection of PRP vs combined PRP and subcision in the treatment of atrophic acne scars.
METHODS


Thirty patients with bilateral atrophic acne scars were enrolled. Each patient received three monthly sessions. Each side of the face was randomly treated either with intradermal PRP alone or with combined treatment with subcision followed by PRP injection. Patients were assessed at 3 and 6 months following the last treatment session. Evaluation of serial photographs was performed by two blinded investigators.
RESULTS


Platelet-rich plasma alone showed a better response, fewer side effects, and shorter downtime compared to combined subcision and PRP.
CONCLUSION


Autologous PRP injection can be a therapeutic option in the treatment of atrophic acne scars, with fewer complications and better tolerability than combined subcision and autologous PRP.",2020,"Autologous PRP injection can be a therapeutic option in the treatment of atrophic acne scars, with fewer complications and better tolerability than combined subcision and autologous PRP.","['Thirty patients with bilateral atrophic acne scars were enrolled', 'atrophic acne scars']","['intradermal PRP alone or with combined treatment with subcision followed by PRP injection', 'autologous platelet-rich plasma vs combined subcision and autologous platelet-rich plasma', 'PRP vs combined PRP and subcision', 'Autologous platelet-rich plasma (PRP', 'Autologous PRP injection']","['side effects, and shorter downtime']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",30.0,0.0169298,"Autologous PRP injection can be a therapeutic option in the treatment of atrophic acne scars, with fewer complications and better tolerability than combined subcision and autologous PRP.","[{'ForeName': 'Akmal Saad', 'Initials': 'AS', 'LastName': 'Hassan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwa Safwat', 'Initials': 'MS', 'LastName': 'El-Hawary', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba Mohammed', 'Initials': 'HM', 'LastName': 'Abdel Raheem', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Samar Hassan', 'Initials': 'SH', 'LastName': 'Abdallah', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Medhat', 'Initials': 'MM', 'LastName': 'El-Komy', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13048']
463,31135099,"""Miliacin encapsulated by polar lipids stimulates cell proliferation in hair bulb and improves telogen effluvium in women"".","BACKGROUND


Miliacin, the main triterpenoid from millet, is known to stimulate keratinocyte metabolism and proliferation. Polar lipids are able to form vesicles with active compounds and to improve their bioavailability.
OBJECTIVES


We aimed to demonstrate potential benefits of a solution of miliacin encapsulated within polar lipids (MePL) on telogen effluvium prevention and hair condition in women.
METHODS


After preliminary cell proliferation studies, a placebo-controlled, multicentric, randomized, double-blind trial was performed on sixty-five nonmenopausal women affected by telogen effluvium, to assess the efficacy of a 12-week oral supplementation with MePL. Telogen and anagen densities were determined by phototrichogram analysis. Scalp dryness and hair brightness were clinically evaluated using a Likert scale.
RESULTS


MePL further enhanced cell proliferation in hair bulb from human scalp than miliacin alone. Compared to the placebo treatment, MePL supplementation significantly reduced telogen density after 12 weeks of treatment. An increase of anagen density was observed in both groups, although there was no significant difference between the two treatments. Scalp dryness was more decreased in the MePL group than in the placebo group. A better improvement of hair brightness was also observed after 12 weeks of supplementation with MePL.
CONCLUSION


Twelve weeks of MePL supplementation significantly reduced the hair density in the telogen phase and, in parallel, improved scalp dryness and hair condition. These effects could be linked to MePL activity on cell proliferation in hair bulb. MePL is an original association of plant extract that could help to prevent and/or limit hair loss in women.",2020,"Twelve weeks of MePL supplementation significantly reduced the hair density in the telogen phase and, in parallel, improved scalp dryness and hair condition.","['sixty-five nonmenopausal women affected by telogen effluvium', 'women']","['placebo', 'oral supplementation with MePL', 'solution of miliacin encapsulated within polar lipids (MePL', 'MePL', 'MePL supplementation']","['hair density', 'cell proliferation', 'scalp dryness and hair condition', 'telogen density', 'Scalp dryness and hair brightness', 'hair brightness', 'anagen density', 'Scalp dryness', 'Telogen and anagen densities']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0263518', 'cui_str': 'Telogen effluvium (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0128503', 'cui_str': 'miliacin'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",65.0,0.143404,"Twelve weeks of MePL supplementation significantly reduced the hair density in the telogen phase and, in parallel, improved scalp dryness and hair condition.","[{'ForeName': 'Mayoura', 'Initials': 'M', 'LastName': 'Keophiphath', 'Affiliation': 'D.I.V.A. Expertise, Toulouse, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Courbière', 'Affiliation': 'Idea Clinic, Martillac, France.'}, {'ForeName': 'Léana', 'Initials': 'L', 'LastName': 'Manzato', 'Affiliation': 'D.I.V.A. Expertise, Toulouse, France.'}, {'ForeName': 'Irène', 'Initials': 'I', 'LastName': 'Lamour', 'Affiliation': 'Robertet Group, Grasse, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Gaillard', 'Affiliation': 'Robertet Group, Grasse, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12998']
464,31941466,Simulated patient's feedback to improve communication skills of clerkship students.,"BACKGROUND


The changing trends of the society and revisions to medical education have changed the way medical students are trained to adroitly care for patients hence, patient centered care has become need of today's society and communication skills are imperative in developing patient physician relationship. Increasingly, simulations are being used to aid medical students to incorporate theoretical knowledge into practice. There are innumerable studies regarding communication skills in terms of reliability, validity and feasibility but no such study has been documented using simulated patient's feedback in improving communication skills in Pakistan. The aim of this study is to explore whether simulated patients' feedback improves the communication skills of undergraduate medical students.
METHODS


During a randomized control trail a group of eighty students in the final year clerkship at Al-Nafees Medical College have participated in pre-post Objective Structured Clinical Exam (OSCE) on communication skills. The students were selected through convenience sampling technique. Four Objective Structured Clinical Exam (OSCE) stations based on different scenarios of communication skills were developed. Each station of fifteen minutes duration was assessed by both simulated patients and faculty using a validated tool LCSAS (Liverpool Communication Skills Assessment Scale). The difference between the pre and post-tests of two groups was explored by applying independent t-test. Cronbach's alpha was used to check the reliability of scores and effect size was calculated.
RESULTS


Results of this study have showed that there is significant improvement in communication skills after receiving feedback from simulated patients (p value ≤0.05) was observed. An overall Cronbach α = 0.83 on LCSAS reveal a high internal consistency and there was adequate demonstration of effect size(r = 0.8).
CONCLUSION


The results on the scores of the students on the Liverpool Communication Skills Assessment Scale confirm that simulated patient's feedback is essential to enhance the communication skills of the medical students. This study offers significant evidence towards successful conduction of a formal communication skills development initiative at Al-Nafees Medical College using simulated patient feedback during teaching and assessments.",2020,"An overall Cronbach α = 0.83 on LCSAS reveal a high internal consistency and there was adequate demonstration of effect size(r = 0.8).
","['clerkship students', 'undergraduate medical students', 'eighty students in the final year clerkship at Al-Nafees Medical College have participated in pre-post Objective Structured Clinical Exam (OSCE) on communication skills']",[],"['tool LCSAS (Liverpool Communication Skills Assessment Scale', 'communication skills']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",[],"[{'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}]",,0.0212896,"An overall Cronbach α = 0.83 on LCSAS reveal a high internal consistency and there was adequate demonstration of effect size(r = 0.8).
","[{'ForeName': 'Ayesha Aleem', 'Initials': 'AA', 'LastName': 'Qureshi', 'Affiliation': 'Department of Health Professions Education, Al-Nafees Medical College & Hospital, Isra University, Islamabad Campus, Islamabad, Pakistan. drayeshafuad@hotmail.com.'}, {'ForeName': 'Tabassum', 'Initials': 'T', 'LastName': 'Zehra', 'Affiliation': 'Department of Educational Development, Aga Khan Medical College, Aga Khan University, Karachi, Pakistan.'}]",BMC medical education,['10.1186/s12909-019-1914-2']
465,31948477,A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients.,"BACKGROUND


Fractures of the distal radius are one of the most common osteoporotic fractures in elderly men and women. These fractures are a particular health concern amongst the elderly, who are at risk of fragility fractures, and are associated with long-term functional impairment, pain and a variety of complications. This is a sentinel event, as these fractures are associated with a two to four times increased risk of subsequent hip fractures in elderly patients. This is an important concept, as it is well established that these patients have an increased risk of falling. Fall prevention is therefore crucial to decrease further morbidity and mortality. The purpose of this study is to investigate the effect of low-magnitude high-frequency vibration (LMHFV) on postural stability and prevention of falls in elderly patients post distal radius fracture.
METHODS


This is a prospective single-blinded randomized controlled trial. Two hundred patients will be recruited consecutively with consent, and randomized to either LMHFV (n = 100) or a control group (n = 100). The primary outcome is postural stability measured by the static and dynamic ability of patients to maintain centre of balance on the Biodex Balance System SD. Secondary outcomes are the occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events. Outcome assessments for both groups will be performed at baseline (0 month) and at 6 weeks, 3 months and 6 months time points.
DISCUSSION


Previous studies have stressed the importance of reducing falls after distal radius fracture has occurred in elderly patients, and an effective intervention is crucial. Numerous studies have proven vibration therapy to be effective in improving balancing ability in normal patients; However, no previous study has applied the device for patients with fractures. Our study will attempt to translate LMHFV to patients with fractures to improve postural stability and prevent recurrent falls. Positive results would provide a large impact on the prevention of secondary fractures and save healthcare costs.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03380884. Registered on 21 December 2017.",2020,"Secondary outcomes are the occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events.","['elderly men and women', 'normal patients', 'Two hundred patients will be recruited consecutively with consent', 'patients with fractures', 'after distal radius fracture in elderly patients', 'elderly patients', 'elderly patients post distal radius fracture']","['vibration therapy', 'low-magnitude high-frequency vibration (LMHFV', 'LMHFV', 'postural training and fall prevention']","['postural stability', 'occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events', 'postural stability measured by the static and dynamic ability of patients to maintain centre of balance on the Biodex Balance System SD', 'postural stability and prevention of falls']","[{'cui': 'C0524337', 'cui_str': 'Elderly man (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",200.0,0.0405234,"Secondary outcomes are the occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events.","[{'ForeName': 'Ronald Man Yeung', 'Initials': 'RMY', 'LastName': 'Wong', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China.'}, {'ForeName': 'Wing-Tung', 'Initials': 'WT', 'LastName': 'Ho', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Hospital Authority, Sha Tin, Hong Kong, China.'}, {'ForeName': 'Chi Yin', 'Initials': 'CY', 'LastName': 'Tso', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Hospital Authority, Sha Tin, Hong Kong, China.'}, {'ForeName': 'Wai Kit Raymond', 'Initials': 'WKR', 'LastName': 'Ng', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Hospital Authority, Sha Tin, Hong Kong, China.'}, {'ForeName': 'Simon Kwoon-Ho', 'Initials': 'SK', 'LastName': 'Chow', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China.'}, {'ForeName': 'Wing-Hoi', 'Initials': 'WH', 'LastName': 'Cheung', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China. louis@ort.cuhk.edu.hk.'}]",Trials,['10.1186/s13063-019-4013-0']
466,31796677,Cerebral White Matter Integrity in Amnestic Mild Cognitive Impairment: A 1-Year Randomized Controlled Trial of Aerobic Exercise Training.,"Cerebral white matter (WM) represents the structural substrate of neuronal communications which is damaged by Alzheimer's disease (AD). Aerobic exercise training (AET) may improve WM integrity in cognitively normal older adults, but its efficacy remains unknown in patients with amnestic mild cognitive impairment (MCI), a prodromal phase of AD dementia. Therefore, we conducted a proof-of-concept study that randomized 70 amnestic MCI patients to a 1-year program of AET or a non-aerobic stretching and toning (SAT), active control group. Thirty-six patients completed both baseline and follow-up MRI scans, and cerebral WM integrity was measured by WM lesion volume and diffusion characteristics using fluid-attenuated-inversion-recovery and diffusion tensor imaging respectively. Peak oxygen uptake (VO2peak) and neuropsychological function were also measured. At baseline and 1-year follow-up, WM lesion volume and diffusion characteristics were similar between the AET and SAT groups, although VO2peak significantly improved after AET. The AET group showed slight improvement in neuropsychological performance. When analyzing individual data, tract-based spatial statistics demonstrated that VO2peak improvements are associated with attenuated elevations in mean and axial diffusivities, particularly the anterior WM fiber tracts (e.g., genu of corpus callosum). In patients with amnestic MCI, we found that although AET intervention did not improve WM integrity at group level analysis, individual cardiorespiratory fitness gains were associated with improved WM tract integrity of the prefrontal cortex.",2020,"At baseline and 1-year follow-up, WM lesion volume and diffusion characteristics were similar between the AET and SAT groups, although VO2peak significantly improved after AET.","['patients with amnestic MCI', 'Amnestic Mild Cognitive Impairment', 'cognitively normal older adults', 'patients with amnestic mild cognitive impairment (MCI), a prodromal phase of AD dementia', '70 amnestic MCI patients to a 1-year program of AET or a non-aerobic stretching and toning (SAT), active control group']","['Aerobic Exercise Training', 'Aerobic exercise training (AET']","['WM integrity', 'WM tract integrity of the prefrontal cortex', 'neuropsychological performance', 'Peak oxygen uptake (VO2peak) and neuropsychological function', 'cerebral WM integrity', 'WM lesion volume and diffusion characteristics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0565928', 'cui_str': 'Prodromal phase (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0629582', 'cui_str': 'AETS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0629582', 'cui_str': 'AETS'}]","[{'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",70.0,0.0839437,"At baseline and 1-year follow-up, WM lesion volume and diffusion characteristics were similar between the AET and SAT groups, although VO2peak significantly improved after AET.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tarumi', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Binu P', 'Initials': 'BP', 'LastName': 'Thomas', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin Y', 'Initials': 'BY', 'LastName': 'Tseng', 'Affiliation': 'Department of Health and Kinesiology, The University of Texas at Tyler, Tyler, TX, USA.'}, {'ForeName': 'Ciwen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Womack', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hynan', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Hanzhang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Advanced Imaging Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'C Munro', 'Initials': 'CM', 'LastName': 'Cullum', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190875']
467,31868666,Comparative Cognitive Effects of Choreographed Exercise and Multimodal Physical Therapy in Older Adults with Amnestic Mild Cognitive Impairment: Randomized Clinical Trial.,"BACKGROUND


Recent research on mild cognitive impairment (MCI) has primarily focused on searching for measures to prevent or delay the progression of MCI to dementia. Physical exercise has shown to be effective in the prevention of age-related cognitive decline in elderly adults with MCI. However, the most effective type and dose of exercise for the improvement of cognition are yet to be determined.
OBJECTIVE


To compare the cognitive effects of choreographed exercise (Choreography group) with a multimodal physical therapy program (Physical Therapy group) in elderly adults with amnestic MCI, a population with an increased risk of developing dementia.
METHODS


We conducted a randomized clinical trial with two parallel groups under allocation concealment and assessor blinding. Participants were allocated into Choreography or Physical Therapy group and performed exercises twice per week in 60-minute sessions during 12 weeks.
RESULTS


Thirty-six participants with amnestic MCI, ages 65 to 85, were assessed at baseline and after 12 weeks of intervention, by comprehensive validated neuropsychological and physical assessments. A Repeated measures General Lineal Model showed statistically significant differences in cognitive and physical outcomes. Both groups significantly improved in visual delayed recall. The Choreography group exhibited significantly more benefits on verbal recognition memory than the Physical Therapy group.
CONCLUSION


Greater cognitive benefits were achieved in the choreographic intervention than in the multimodal physical therapy, mainly in those functions more related to the risk of conversion to dementia. Additional studies are needed to confirm whether the observed effects are related to delayed onset of Alzheimer's disease in elderly adults with amnestic MCI.",2020,"CONCLUSION


Greater cognitive benefits were achieved in the choreographic intervention than in the multimodal physical therapy, mainly in those functions more related to the risk of conversion to dementia.","['elderly adults with MCI', 'elderly adults with amnestic MCI', 'Older Adults with Amnestic Mild Cognitive Impairment', 'mild cognitive impairment (MCI', 'elderly adults with amnestic MCI, a population with an increased risk of developing dementia']","['Choreography or Physical Therapy group and performed exercises', 'choreographic intervention', 'Choreographed Exercise and Multimodal Physical Therapy', 'choreographed exercise (Choreography group) with a multimodal physical therapy program (Physical Therapy group', 'Physical exercise']","['cognitive benefits', 'visual delayed recall', 'verbal recognition memory', 'cognitive and physical outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",36.0,0.0546262,"CONCLUSION


Greater cognitive benefits were achieved in the choreographic intervention than in the multimodal physical therapy, mainly in those functions more related to the risk of conversion to dementia.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bisbe', 'Affiliation': 'Department of Physical Therapy and Nursing of Blanquerna School of Health Sciences, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fuente-Vidal', 'Affiliation': 'Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O), University of Vic, Barcelona, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'López', 'Affiliation': 'Department of Psychology of Blanquerna Faculty of Psychology, Education and Sports Sciences, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Moreno', 'Affiliation': 'Physical Therapy Ambulatory Service, Barcelona, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Naya', 'Affiliation': 'Physical Therapy Ambulatory Service, Barcelona, Spain.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'de Benetti', 'Affiliation': 'Physical Therapy Ambulatory Service, Barcelona, Spain.'}, {'ForeName': 'Raimon', 'Initials': 'R', 'LastName': 'Milà', 'Affiliation': 'Department of Physical Therapy and Nursing of Blanquerna School of Health Sciences, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bruna', 'Affiliation': 'Department of Psychology of Blanquerna Faculty of Psychology, Education and Sports Sciences, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': 'Research Center and Memory Clinic. Fundació ACE. Institut Català de Neurociències Aplicades. Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Alegret', 'Affiliation': 'Research Center and Memory Clinic. Fundació ACE. Institut Català de Neurociències Aplicades. Universitat Internacional de Catalunya, Barcelona, Spain.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190552']
468,31435716,The effect of music on pain and subjective experience in image-guided musculoskeletal corticosteroid injections: a randomized controlled trial.,"PURPOSE


To investigate the role of music on subjects undergoing routine image-guided musculoskeletal corticosteroid injections and its effect on post-procedure pain and subjective overall experience.
MATERIALS AND METHODS


This prospective study was IRB-approved and HIPAA-compliant. A total of 126 subjects referred for outpatient image-guided musculoskeletal corticosteroid injections were enrolled in the study and randomized into a music offered group ((+)MO) and a no music offered group ((-)MO). (+)MO subjects were given the opportunity to listen to music during their corticosteroid injection. All subjects were then given an anonymous survey on which they recorded their pre-procedural and post-procedural pain on a scale from 0 to 9 and rated their overall experience and how likely they were to recommend our department for musculoskeletal procedures on scales from 1 to 5.
RESULTS


(+)MO subjects had significantly lower post-procedural pain (p = 0.013) and significantly greater decrease in pain (p = 0.031) compared to (-)MO subjects. Among the (+)MO subjects, there was no statistically significant difference in post-procedure pain (p = 0.34) or change in pain (p = 0.62) if music was accepted or declined. However, subjects who listened to music did have lower post-procedural pain compared to those who did not listen to music (p = 0.012), although the differences in the decrease of pain between the two groups did not quite reach statistical significance (p = 0.062).
CONCLUSIONS


Playing music during image-guided musculoskeletal corticosteroid injections may reduce patients' post-procedure pain. Offering patients some measure of control over their procedure may be a factor that contributes to decreased post-procedure pain as well.",2020,+)MO subjects had significantly lower post-procedural pain (p = 0.013) and significantly greater decrease in pain (p = 0.031) compared to (-)MO subjects.,"['126 subjects referred for outpatient image-guided musculoskeletal corticosteroid injections', 'subjects undergoing']","['routine image-guided musculoskeletal corticosteroid injections', 'music offered group ((+)MO) and a no music offered group ((-)MO']","['lower post-procedural pain', 'pain', 'post-procedure pain', 'change in pain', 'post-procedural pain', 'pain and subjective experience']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0877303', 'cui_str': 'Post procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",126.0,0.084775,+)MO subjects had significantly lower post-procedural pain (p = 0.013) and significantly greater decrease in pain (p = 0.031) compared to (-)MO subjects.,"[{'ForeName': 'Weier', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, MA, 02114, USA.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Bryan', 'Affiliation': 'Santa Barbara Radiology Medical Group, Santa Barbara, CA, 93105, USA.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Kheterpal', 'Affiliation': 'Department of Radiology, Division of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital, 55 Fruit Street, Yawkey 6E, Boston, MA, 02114, USA.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Simeone', 'Affiliation': 'Department of Radiology, Division of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital, 55 Fruit Street, Yawkey 6E, Boston, MA, 02114, USA.'}, {'ForeName': 'Connie Y', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiology, Division of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital, 55 Fruit Street, Yawkey 6E, Boston, MA, 02114, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Division of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital, 55 Fruit Street, Yawkey 6E, Boston, MA, 02114, USA.'}, {'ForeName': 'Ambrose J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Radiology, Division of Musculoskeletal Imaging and Intervention, Massachusetts General Hospital, 55 Fruit Street, Yawkey 6E, Boston, MA, 02114, USA. ajhuang@mgh.harvard.edu.'}]",Skeletal radiology,['10.1007/s00256-019-03298-7']
469,31982075,"Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


In chronic central serous chorioretinopathy (CSCR), fluid accumulates in the subretinal space. CSCR is a common visually disabling condition that develops in individuals up to 60 years of age, and there is no definitive treatment. Previous research suggests the mineralocorticoid receptor antagonist, eplerenone, is effective for treating CSCR; however, this drug is not licensed for the treatment of patients with CSCR. We aimed to evaluate whether eplerenone was superior to placebo in terms of improving visual acuity in patients with chronic CSCR.
METHODS


This randomised, double-blind, parallel-group, multicentre placebo-controlled trial was done at 22 hospitals in the UK. Participants were eligible if they were aged 18-60 years and had had treatment-naive CSCR for 4 months or more. Patients were randomly assigned (1:1) to either the eplerenone or the placebo group by a trial statistician through a password-protected system online. Allocation was stratified by best-corrected visual acuity (BCVA) and hospital. Patients were given either oral eplerenone (25 mg/day for 1 week, increasing to 50 mg/day for up to 12 months) plus usual care or placebo plus usual care for up to 12 months. All participants, care teams, outcome assessors, pharmacists, and members of the trial management group were masked to the treatment allocation. The primary outcome was BCVA, measured as letters read, at 12 months. All outcomes apart from safety were analysed on a modified intention-to-treat basis (participants who withdrew consent without contributing a post-randomisation BCVA measurement were excluded from the primary analysis population and from most secondary analysis populations). The trial is registered with ISRCTN, ISRCTN92746680, and is completed.
FINDINGS


Between Jan 11, 2017, and Feb 22, 2018, we enrolled and randomly assigned 114 patients to receive either eplerenone (n=57) or placebo (n=57). Three participants in the placebo group withdrew consent without contributing a post-randomisation BCVA measurement and were excluded from the primary outcome analysis population. All patients from the eplerenone group and 54 patients from the placebo group were included in the primary outcome. Modelled mean BCVA at 12 months was 79·5 letters (SD 4·5) in the placebo group and 80·4 letters (4·6) in the eplerenone group, with an adjusted estimated mean difference of 1·73 letters (95% CI -1·12 to 4·57; p=0·24) at 12 months. Hyperkalaemia occurred in eight (14%) patients in each group. No serious adverse events were reported in the eplerenone group and three unrelated serious adverse events were reported in the placebo group (myocardial infarction [anticipated], diverticulitis [unanticipated], and metabolic surgery [unanticipated]).
INTERPRETATION


Eplerenone was not superior to placebo for improving BCVA in people with chronic CSCR after 12 months of treatment. Ophthalmologists who currently prescribe eplerenone for CSCR should discontinue this practice.
FUNDING


Efficacy and Mechanism Evaluation Programme, and National Institute for Health Research and Social Care.",2020,"INTERPRETATION


Eplerenone was not superior to placebo for improving BCVA in people with chronic CSCR after 12 months of treatment.","['patients with chronic CSCR', 'chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months (VICI', 'Between Jan 11, 2017, and Feb 22, 2018, we enrolled and randomly assigned 114 patients to receive either', 'patients with CSCR', '22 hospitals in the UK', 'Participants were eligible if they were aged 18-60 years and had had treatment-naive CSCR for 4 months or more']","['Eplerenone', 'usual care or placebo', 'oral eplerenone', 'placebo', 'eplerenone or the placebo', 'CSCR', 'eplerenone']","['visual acuity', 'serious adverse events', 'Modelled mean BCVA', 'BCVA, measured as letters read', 'Hyperkalaemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0730314', 'cui_str': 'Chronic central serous chorioretinopathy (disorder)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}]",114.0,0.755863,"INTERPRETATION


Eplerenone was not superior to placebo for improving BCVA in people with chronic CSCR after 12 months of treatment.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lotery', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. Electronic address: a.j.lotery@soton.ac.uk.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': ""O'Connell"", 'Affiliation': 'Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Rosie A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Cree', 'Affiliation': 'Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Madhusudhan', 'Affiliation': ""Liverpool Ophthalmic Reading Centre, St Paul's Eye Unit, Royal Liverpool University Hospitals NHS Trust, Liverpool, UK.""}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Behar-Cohen', 'Affiliation': 'P-HP Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Ophtalmopole, Université de Paris, Paris, France; Centre de Recherche des Cordeliers, INSERM UMR 1138, Université de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Centre for Vision Sciences, The Queen's University of Belfast, Belfast, UK.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""Centre for Vision Sciences, The Queen's University of Belfast, Belfast, UK.""}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32981-2']
470,31937355,Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial.,"BACKGROUND


Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit).
METHODS/DESIGN


The study is an interventional randomised controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental group or the active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates in a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by eight 45-min sessions and are administered in the GRAIL VR laboratory (Motekforce Link, Netherlands), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) of the two trainings (T1) and at the end (T2). Moreover, a battery of neurocognitive tests spanning different domains is administered to all participants at T0, T2 and in a follow-up session after 2 months from the end of the two trainings (T3).
DISCUSSION


This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new, intensive, social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN 22332873. Retrospectively registered on 12 March 2018.",2020,"We aim to investigate the feasibility and efficacy of a new, intensive, social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations.","['Patients with cerebellar malformations', 'paediatric patients with congenital cerebellar diseases', '42 children, adolescents and young adults with congenital cerebellar malformations', 'Italian patients aged 7-25\u2009years with congenital cerebellar malformations']","['new, intensive, social cognition training', 'Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT', 'ID', 'VR-training with standard games currently adopted for motor rehabilitation']","['cognitive performance', 'feasibility and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243070', 'cui_str': 'malformations'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0007760', 'cui_str': 'Cerebellum Diseases'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1705899', 'cui_str': 'Spirit (basic dose form)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}]",[],,0.0250384,"We aim to investigate the feasibility and efficacy of a new, intensive, social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations.","[{'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Butti', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy. niccolo.butti@lanostrafamiglia.it.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Biffi', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Genova', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Romaniello', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Davide Felice', 'Initials': 'DF', 'LastName': 'Redaelli', 'Affiliation': 'Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Reni', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Borgatti', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Urgesi', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy. cosimo.urgesi@uniud.it.'}]",Trials,['10.1186/s13063-019-4001-4']
471,31967599,Anterior cruciate ligament injuries treated with quadriceps tendon autograft versus hamstring autograft: A randomized controlled trial.,"Background


One of the most common grafts used to repair anterior cruciate ligament (ACL) rupture is the hamstring tendon (HT) autograft. However, another proposed option to repair the ACL is the quadriceps tendon (QT) autograft. This study aimed to compare the pain and clinical results between patients with ACL injury treated with QT autograft and with HT autograft.
Materials and methods


The Ethics and Investigation Committee of our institution approved the study. The patients were randomized into two groups: one group was treated with QT autograft and the other group was treated with HT autograft. The patients were evaluated preoperatively and postoperatively using the Lysholm-Tegner score, International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, and visual analog scale (VAS), at 2 weeks and 1, 3, 6, and 12 months.
Results


A total of 28 patients with a primary ACL injury were included in the study. No significant differences in VAS pain, Lysholm knee and Tegner activity scale scores, and IKDC score between the HT and QT groups were observed at any time point. All patients had favorable outcomes and significantly improved evaluation scores.
Conclusion


The patients treated with QT autograft had clinical results and post-operative pain similar to those of patients treated with HT autograft for ACL reconstruction.",2020,"No significant differences in VAS pain, Lysholm knee and Tegner activity scale scores, and IKDC score between the HT and QT groups were observed at any time point.","['Anterior cruciate ligament injuries treated with', '28 patients with a primary ACL injury were included in the study', 'patients with ACL injury treated with']","['repair anterior cruciate ligament (ACL) rupture', 'HT autograft', 'QT autograft and with HT autograft', 'QT autograft', 'quadriceps tendon autograft versus hamstring autograft']","['clinical results and post-operative pain', 'VAS pain, Lysholm knee and Tegner activity scale scores, and IKDC score', 'evaluation scores', 'Lysholm-Tegner score, International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, and visual analog scale (VAS']","[{'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",28.0,0.0379698,"No significant differences in VAS pain, Lysholm knee and Tegner activity scale scores, and IKDC score between the HT and QT groups were observed at any time point.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Vilchez-Cavazos', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Dávila-Martínez', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Santiago de la', 'Initials': 'S', 'LastName': 'Garza-Castro', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Simental-Mendía', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Garay-Mendoza', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Yadira', 'Initials': 'Y', 'LastName': 'Tamez-Mata', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Peña-Martínez', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Acosta-Olivo', 'Affiliation': 'Departamento de Ortopedia y Traumatología, Hospital Universitario ""Dr. José E. González"", Universidad Autónoma de Nuevo León, Monterrey, Nuevo Léon, México.'}]",Cirugia y cirujanos,['10.24875/CIRU.19001001']
472,31960175,Experience Versus Report: Where Are Changes Seen After Exposure-Based Cognitive-Behavioral Therapy? A Randomized Controlled Group Treatment of Childhood Social Anxiety Disorder.,"A considerable number of children and adolescents with social anxiety disorder (SAD) do not benefit from treatment as much as expected. However, treatment success should not be measured with social anxiety reports alone; the cognitive, behavioral, and physiological components of social stress should also be assessed. The authors examined an exposure-based SAD-specific group cognitive behavioral therapy (CBT) in a randomized controlled trial (N = 67, age 9-13 years, blind randomized allocation to treatment [CBT; n = 31] and waitlist control [WLC; n = 36] groups). Success was operationalized as a clinically significant reduction of symptoms measured with SAD-specific questionnaires, structured interviews, and changes in response to the Trier Social Stress Test (TSST). In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40). No significant results involving group appeared for negative cognitions, behavior and physiology. Children in the CBT group, but not parents, further reported less social anxiety in one questionnaire from pre- to post-treatment (d = 0.89). A structured interview confirmed a decrease in severity of SAD in the CBT group. While the gold standard of a blind interview showed efficacy of treatment, not all trait and state measures demonstrated similar success patterns.Trial registration Eligibility criteria and some of the dependent variables (cognitions, physiology) for treatment success were registered with the German Research Foundation (TU 78/5-2, HE 3342/4-2) prior to recruitment. Clinical assessment of diagnosis and behavioral data were not a priori planned as outcome measures for this trial and therefore analyzed in a post-hoc approach.",2020,"In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40).","['N\u2009=\u200967, age 9-13\xa0years', 'children and adolescents with social anxiety disorder (SAD', 'Childhood Social Anxiety Disorder']","['WLC', 'exposure-based SAD-specific group cognitive behavioral therapy (CBT', 'CBT', 'waitlist control [WLC', 'TSST']","['severity of SAD', 'SAD-specific questionnaires, structured interviews, and changes in response to the Trier Social Stress Test (TSST', 'negative cognitions, behavior and physiology', 'positive cognitions', 'social anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0270305', 'cui_str': 'Avoidant disorder of childhood (disorder)'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}]",,0.0322738,"In the CBT group, there was a trend toward a significant increase in positive cognitions in the TSST after treatment (d = 0.37), whereas these positive cognitions decreased in the WLC group (d = 0.40).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Asbrand', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany. julia.asbrand@psychologie.uni-freiburg.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schmidtendorf', 'Affiliation': 'Department of Psychology, University of Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Brunna', 'Initials': 'B', 'LastName': 'Tuschen-Caffier', 'Affiliation': 'Department of Psychology, University of Freiburg, Freiburg im Breisgau, Germany.'}]",Child psychiatry and human development,['10.1007/s10578-019-00954-w']
473,31413163,Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial.,"This international randomised controlled trial evaluated whether COPD patients with comorbidities, trained in using patient-tailored multidisease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification II-IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression) were randomised to a patient-tailored self-management intervention (n=102) or UC (n=99). Daily symptom diaries were completed for 12 months. The primary outcome ""COPD exacerbation days per patient per year"" was assessed using intention-to-treat analyses.No significant difference was observed in the number of COPD exacerbation days per patient per year (self-management: median 9.6 (interquartile range (IQR) 0.7-31.1); UC: median 15.6 (IQR 3.0-40.3); incidence rate ratio (IRR) 0.87 (95% CI 0.54; 1.39); p=0.546). There was a significantly shorter duration per COPD exacerbation for self-management (self-management: median 8.1 (IQR 4.8-10.1) days; UC: median 9.5 (IQR 7.0-15.1) days; p=0.021), with no between-group differences in the total number of respiratory hospitalisations (IRR 0.76 (95% CI 0.42; 1.35); p=0.348), but a lower probability of ≥1 for respiratory-related hospitalisation compared to UC (relative risk 0.55 (95% CI 0.35; 0.87); p=0.008). No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); relative risk 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.",2019,"No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); RR 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.","['COPD patients with comorbidities, trained in using patient-tailored multi-disease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (GOLD II-IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression', 'patients with COPD and comorbidities']",['patient-tailored self-management intervention (n=102) or UC'],"['shorter duration per COPD exacerbation', 'Daily symptom diaries', 'number of COPD exacerbation', 'mortality', 'total number of respiratory hospitalisations', 'duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation', 'Incidence Rate Ratio (IRR) 0.87', 'cause hospitalisations', 'COPD exacerbation days/patient/year']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0235874', 'cui_str': 'Disease Exacerbation'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.252026,"No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); RR 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.","[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Lenferink', 'Affiliation': 'Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands a.lenferink@mst.nl.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Paul D L P M', 'Initials': 'PDLPM', 'LastName': 'van der Valk', 'Affiliation': 'Dept of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cafarella', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'van Veen', 'Affiliation': 'Dept of Pulmonary Medicine, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Dept of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia.'}, {'ForeName': 'Catharina G M', 'Initials': 'CGM', 'LastName': 'Groothuis-Oudshoorn', 'Affiliation': 'Dept of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Morton G', 'Initials': 'MG', 'LastName': 'Burt', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': 'Dept of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Frith', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Tanja W', 'Initials': 'TW', 'LastName': 'Effing', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}]",The European respiratory journal,['10.1183/13993003.02134-2018']
474,31968063,Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,"Importance


Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.
Objective


To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.
Design, Setting, and Participants


This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.
Interventions


Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.
Main Outcomes and Measures


The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.
Results


Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups.
Conclusions and Relevance


In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.
Trial Registration


ClinicalTrials.gov identifier: NCT02502760.",2020,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","['Frail Patients Undergoing Resection of Colorectal Cancer', '298 patients were excluded (not frail [n\u2009=\u2009290], unable to exercise [n\u2009=\u20093], and planned neoadjuvant treatment [n\u2009=\u20095]), and 120 frail patients (Fried Frailty Index,≥2', '110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups', 'patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019', 'frail patients undergoing colorectal cancer resection (predominantly minimally invasive', '418 patients 65 years or older were assessed for eligibility', 'Ten patients were excluded after randomization because they refused surgery (n\u2009=\u20093), died before surgery (n\u2009=\u20093), had no cancer (n\u2009=\u20091), had surgery without bowel resection (n\u2009=\u20091), or were switched to palliative care (n\u2009=\u20092', 'frail patients preoperatively', 'frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation', '110 patients randomized', ' mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery', 'Frail patients']","['prehabilitation program', 'Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery', 'Multimodal Prehabilitation vs Postoperative Rehabilitation']","['30-day Comprehensive Complications Index', '30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures', '30-Day Postoperative Complications', 'Comprehensive Complications Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",110.0,0.282382,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bousquet-Dion', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Elsherbini', 'Affiliation': 'Currently a medical student at Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jagoe', 'Affiliation': 'Department of Medicine, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': 'Department of Anesthesia, McGill Research Centre for Physical Activity and Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}]",JAMA surgery,['10.1001/jamasurg.2019.5474']
475,31937322,Simultaneous reduction of flow and fraction of inspired oxygen (FiO 2 ) versus reduction of flow first or FiO 2  first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial).,"BACKGROUND


High-flow nasal cannula (HFNC) oxygen therapy has been widely used in critically ill patients. Despite the effectiveness of HFNC as a treatment, optimal methods to withdraw HFNC after recovery from preexisting conditions have not been investigated to date. In this study, we will evaluate the safety and efficacy of simultaneous reduction of flow and fraction of inspired oxygen (FiO 2 ) compared with sequential reduction of either flow first or FiO 2  reduction first in patients with HFNC.
METHODS/DESIGN


This is a prospective, investigator-initiated, randomized controlled trial with three experimental intervention groups. A total of 100 adult patients receiving HFNC and satisfying weaning criteria will be enrolled and randomly assigned to one of the following groups: flow reduction (FR) first, FiO 2  reduction (OR) first, or simultaneous reduction (SR). In the FR group, flow will be reduced first by 10 L/min/h. When it reaches 20 L/min, FiO 2  will then be reduced by 0.1 /h until it reaches 0.3. In the OR group, the FiO 2  will be gradually reduced first by 0.1 /h until it reaches 0.3, then flow will be reduced by 10 L/min until it reaches 20 L/min. Finally, in the SR group, both the flow and FiO 2  will be gradually reduced simultaneously by 10 L/min and 0.1/h, respectively. Weaning will proceed only when patients satisfy the weaning criteria at every weaning point. When the HFNC weaning-off targets are reached (20 L/min and 0.3 for flow and FiO 2,  respectively), the patient will be transferred to conventional oxygen therapy (mainly low-flow nasal prongs). The primary outcome is the time to successful weaning from HFNC for 24 h. Secondary outcomes will include the success or failure rate in weaning off HFNC and changes in arterial blood gas analyses, intolerance rate, length of hospital stay, and in-hospital mortality.
DISCUSSION


This study will be the first clinical trial to investigate the safety and efficacy of three different methods of weaning in adult patients receiving HFNC. Once this study is completed, we expect to be able to suggest the better strategy for withdrawal of HFNC based on the results.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03845244. Registered on 19 February 2019.",2020,"The primary outcome is the time to successful weaning from HFNC for 24 h. Secondary outcomes will include the success or failure rate in weaning off HFNC and changes in arterial blood gas analyses, intolerance rate, length of hospital stay, and in-hospital mortality.
","['patients with HFNC', 'adult patients receiving HFNC', 'critically ill patients', '100 adult patients receiving HFNC and satisfying weaning criteria']","['flow reduction (FR) first, FiO 2  reduction (OR) first, or simultaneous reduction (SR', 'High-flow nasal cannula (HFNC) oxygen therapy', 'HFNC']","['time to successful weaning from HFNC', 'safety and efficacy', 'success or failure rate in weaning off HFNC and changes in arterial blood gas analyses, intolerance rate, length of hospital stay, and in-hospital mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",100.0,0.197413,"The primary outcome is the time to successful weaning from HFNC for 24 h. Secondary outcomes will include the success or failure rate in weaning off HFNC and changes in arterial blood gas analyses, intolerance rate, length of hospital stay, and in-hospital mortality.
","[{'ForeName': 'Min Chul', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon Joo', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Sun', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Jae', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Il', 'Initials': 'HI', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Choon-Taek', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Sun', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. apolio3700@gmail.com.'}]",Trials,['10.1186/s13063-019-4019-7']
476,31937342,Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial.,"BACKGROUND


The prevention of catheter-related complications is nowadays an important topic of research. Flushing catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing should be carried out both pre- and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, and also increasing the need for manipulation of the venous catheter).
METHODS/DESIGN


A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes (arm B). The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day.
DISCUSSION


The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of this medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate nurses' adoption of good clinical practices in intravenous procedures, reducing catheter manipulations.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04046770. Registered 13 August 2019.",2020,"The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups.",['146 adult patients'],"['usual intravenous administration drugs with flushing procedures, with a double-chamber syringe (arm A) or with classic syringes', 'Double-chamber syringe versus classic syringes', 'Flushing catheters']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013125'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0039142', 'cui_str': 'Syringes'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}]",[],146.0,0.236068,"The outcomes assessment will be performed on a daily basis by an unblinded ward team, with the same procedures in both groups.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Parreira', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra (ESEnfC), Avenida Bissaya Barreto, Apartado 7001, 3046-851, Coimbra, Portugal. parreira@esenfc.pt.'}, {'ForeName': 'Liliana B', 'Initials': 'LB', 'LastName': 'Sousa', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra (ESEnfC), Avenida Bissaya Barreto, Apartado 7001, 3046-851, Coimbra, Portugal.'}, {'ForeName': 'Inês A', 'Initials': 'IA', 'LastName': 'Marques', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra (ESEnfC), Avenida Bissaya Barreto, Apartado 7001, 3046-851, Coimbra, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Santos-Costa', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra (ESEnfC), Avenida Bissaya Barreto, Apartado 7001, 3046-851, Coimbra, Portugal.'}, {'ForeName': 'Luciene M', 'Initials': 'LM', 'LastName': 'Braga', 'Affiliation': 'Departamento Medicina e Enfermagem, Universidade Federal Viçosa, Av. Peter Henry Rolfs, s/n Campus Universitário, Viçosa, MG, 36570-900, Brazil.'}, {'ForeName': 'Arménio', 'Initials': 'A', 'LastName': 'Cruz', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra (ESEnfC), Avenida Bissaya Barreto, Apartado 7001, 3046-851, Coimbra, Portugal.'}, {'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Salgueiro-Oliveira', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra (ESEnfC), Avenida Bissaya Barreto, Apartado 7001, 3046-851, Coimbra, Portugal.'}]",Trials,['10.1186/s13063-019-3887-1']
477,31937350,A study protocol for a randomised trial of adjunct computerised memory specificity training (c-MeST) for major depression in youth: targeting cognitive mechanisms to enhance usual care outcomes in mental health settings.,"BACKGROUND


Youth depression is highly prevalent and is related to impairments in academic, social and behavioural functioning. Evidence-based treatments are available, but many young people do not respond or sufficiently recover with first-line options, and a significant proportion experience relapse. Consequently, there is clear scope to enhance intervention in this critical period of early-onset depression. Memory specificity training (MeST) is a low-intensity intervention for depression that targets reduced specificity when recalling memories of the past, a common cognitive vulnerability in depression. This randomised controlled trial will assess the efficacy of adding a computerised version of MeST (c-MeST) to usual care for youth depression.
METHODS/DESIGN


Young people aged 15-25 years with a major depressive episode (MDE) will be recruited and randomised to have immediate access to the seven session online c-MeST program in addition to usual care, or to usual care and wait-list for c-MeST. The primary outcomes will be diagnostic status of an MDE and self-reported depressive symptoms assessed at baseline, 1-, 3- and 6-month intervals. Autobiographical memory specificity and other variables thought to contribute to the maintenance of reduced memory specificity and depression will be assessed as mediators of change.
DISCUSSION


Online provision of c-MeST provides a simple, low-intensity option for targeting a cognitive vulnerability that predicts the persistence of depressive symptoms. If found to be efficacious as an adjunct to usual care for depressed youth, it could be suitable for broader roll-out, as c-MeST is highly accessible and implementation requires only minimal resources due to the online and automated nature of intervention.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12619000234112p. Registered on the 18 February 2019. All items from the WHO Trial Registration Data Set can be found within the protocol.
PROTOCOL VERSION


1.0.",2020,"This randomised controlled trial will assess the efficacy of adding a computerised version of MeST (c-MeST) to usual care for youth depression.
","['Young people aged 15-25 years with a major depressive episode (MDE', 'major depression in youth', 'mental health settings']","['computerised version of MeST (c-MeST', 'Memory specificity training (MeST', 'adjunct computerised memory specificity training (c-MeST', 'seven session online c-MeST program in addition to usual care, or to usual care and wait-list for c-MeST']","['Autobiographical memory specificity', 'diagnostic status of an MDE and self-reported depressive symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.156144,"This randomised controlled trial will assess the efficacy of adding a computerised version of MeST (c-MeST) to usual care for youth depression.
","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, Melbourne, Victoria, 3220, Australia. david.hallford@deakin.edu.au.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Carmichael', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, Melbourne, Victoria, 3220, Australia.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Austin', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, Melbourne, Victoria, 3220, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Ludwig-Maximilians-University Munich, Leopoldstr. 131, 80802, Munich, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Raes', 'Affiliation': 'Faculty of Psychology and Educational Sciences, KU Leuven, Tiensestraat 102, Box 3712, 3000, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, Melbourne, Victoria, 3220, Australia.'}]",Trials,['10.1186/s13063-019-4036-6']
478,31937352,KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial.,"BACKGROUND


Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA.
METHODS/DESIGN


We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2 g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses.
DISCUSSION


This study will provide high-quality evidence to assess whether krill oil 2 g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111-1181-7087.",2020,"Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks.","['knee osteoarthritis', 'older adults with clinical knee OA and knee effusion-synovitis', 'Knee osteoarthritis (OA', '260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth']","['Krill oil versus placebo', 'Krill oil', 'receiving 2\u2009g/day krill oil or inert placebo']","['absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis', 'knee pain and systemic inflammation', 'knee pain', 'pain and effusion-synovitis size', 'Knee symptoms, function and MRI structural abnormalities']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0343166', 'cui_str': 'Knee joint effusion (disorder)'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439417', 'cui_str': 'g/day'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0343166', 'cui_str': 'Knee joint effusion (disorder)'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013687', 'cui_str': 'Effusion (morphologic abnormality)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",260.0,0.218198,"Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks.","[{'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Laslett', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, TAS, 7000, Australia. Laura.Laslett@utas.edu.au.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'The Queen Elizabeth Hospital, University of Adelaide, Woodville, SA, 5011, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'March', 'Affiliation': 'Royal North Shore Hospital, The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'H I', 'Initials': 'HI', 'LastName': 'Keen', 'Affiliation': 'Department of Rheumatology, Fiona Stanley Hospital, Murdoch Drive, Murdoch, WA, 6150, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Otahal', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Private Bag 23, Hobart, TAS, 7000, Australia.'}]",Trials,['10.1186/s13063-019-3915-1']
479,31774541,Recruitment and Retention in a Randomized Control Trial of Increased Dietary Protein-to-Carbohydrate Ratios in Patients with Psoriasis.,,2020,,['Patients with Psoriasis'],['Increased Dietary Protein-to-Carbohydrate Ratios'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",[],,0.0302663,,"[{'ForeName': 'Anders Nikolai Ørsted', 'Initials': 'ANØ', 'LastName': 'Schultz', 'Affiliation': 'LEO Innovation Lab, LEO Pharma, DK-1113 Copenhagen, Denmark. anders.schultz@yahoo.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'John Robert', 'Initials': 'JR', 'LastName': 'Zibert', 'Affiliation': ''}, {'ForeName': 'Maria Falck', 'Initials': 'MF', 'LastName': 'Stigsby', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Malmstedt-Miller', 'Affiliation': ''}, {'ForeName': 'Elisabeth B M', 'Initials': 'EBM', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Skov', 'Affiliation': ''}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Stigsby', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3380']
480,31941539,Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT).,"BACKGROUND


There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management.
METHODS


This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results.
DISCUSSION


This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination.
TRIAL REGISTRATION


The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.",2020,The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types.,"['women with early-stage breast cancer', 'early stage breast cancer patients', 'breast cancer patients']","['OWise', 'standard care or standard care plus OWise']","['health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.118207,The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types.,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Lidington', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'McGrath', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Noble', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Stanway', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'Discover at Imperial College Health Partners, London, United Kingdom.'}, {'ForeName': 'Kabir', 'Initials': 'K', 'LastName': 'Mohammed', 'Affiliation': 'Discover at Imperial College Health Partners, London, United Kingdom.'}, {'ForeName': 'Winette', 'Initials': 'W', 'LastName': 'van der Graaf', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Husson', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands. olga.husson@icr.ac.uk.'}]",Trials,['10.1186/s13063-019-3971-6']
481,31918232,The relationship between perceived stress and depression in substance use disorder treatment.,"BACKGROUND


Depression is highly prevalent among individuals with substance use disorders (SUDs), especially women, and has been noted to improve during SUD treatment. Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment. The aim of this study was to investigate among adults enrolled in SUD treatment whether levels of perceived stress and substance use over the course of treatment were related to reduction in depression.
METHODS


This is a secondary analysis of data from the Women's Recovery Group Study. Women (n = 100) were randomized to either single- or mixed-gender group therapy and men (n = 58) received mixed-gender group therapy. Measures of substance use, perceived stress and depressive symptoms were collected for 6 months following treatment completion. In this study, we used lagged mixed models to investigate whether levels of substance use and perceived stress at each time point were associated with changes in depression at the subsequent time point.
RESULTS


Results indicated that depressive symptoms significantly improved over time. Both substance use and perceived stress were associated with subsequent depressive symptoms. Importantly, stress was associated with symptoms when controlling for substance use, suggesting that changes in depressive symptoms were not solely attributable to levels of substance use.
CONCLUSIONS


These results suggest that both stress and substance use are associated with improvements in depressive symptoms in substance use disorder treatment. Although preliminary, these results provide further support for the importance of targeting stress reduction in people with substance use disorders.",2020,Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment.,"['people with substance use disorders', 'individuals with substance use disorders (SUDs), especially women', 'adults enrolled in SUD', 'Women (n\u2009=\u2009100']",['single- or mixed-gender group therapy and men (n\u2009=\u200958) received mixed-gender group therapy'],"['substance use, perceived stress and depressive symptoms', 'depressive symptoms']","[{'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.04352,Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment.,"[{'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA. Electronic address: kmchugh@mclean.harvard.edu.'}, {'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Sugarman', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA.'}, {'ForeName': 'Garrett M', 'Initials': 'GM', 'LastName': 'Fitzmaurice', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'McLean Hospital, 115 Mill Street, Belmont, MA, 02478, USA; Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107819']
482,31571329,The effectiveness of Botulinum Toxin A for treatment of upper limb impairments and dysfunctions in breast cancer survivors: A randomised controlled trial.,"OBJECTIVE


To examine the effectiveness of a single Botulinum Toxin A (BTX-A) infiltration in the pectoralis major muscle, in addition to a standard physical therapy (PT) programme on upper limb impairments and dysfunctions after breast cancer treatment.
METHODS


Fifty breast cancer patients with persistent pain 3 months after finishing treatment participated in a double-blinded randomised controlled trial. The intervention group received a single BTX-A infiltration. The control group received a placebo (saline) infiltration. Within one week after the infiltration, all patients attended an individual PT programme (12 sessions) during the first 3 months. Outcome parameters were active shoulder range of motion, upper limb strength, scapular statics and shoulder function. Measures were taken before the intervention, at 1, 3 (i.e. after the intervention) and 6 months follow-up.
RESULTS


No differences between groups were found for all outcome parameters over the course of 6 months. However, overall beneficial effects of the PT for active forward flexion shoulder range of motion and shoulder function were found in both groups.
CONCLUSION


A single Botulinum Toxin A (BTX-A) infiltration in the pectoralis major muscle, in addition to a PT programme cannot be recommended to treat upper limb impairments and dysfunctions after breast cancer treatment.",2020,"However, overall beneficial effects of the PT for active forward flexion shoulder range of motion and shoulder function were found in both groups.
","['Fifty breast cancer patients with persistent pain 3\xa0months after finishing treatment participated', 'upper limb impairments and dysfunctions after breast cancer treatment', 'breast cancer survivors']","['single Botulinum Toxin A (BTX-A) infiltration', 'Botulinum Toxin A', 'Botulinum Toxin A (BTX-A) infiltration', 'single BTX-A infiltration', 'placebo (saline) infiltration', 'standard physical therapy (PT) programme']","['active shoulder range of motion, upper limb strength, scapular statics and shoulder function', 'active forward flexion shoulder range of motion and shoulder function']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",50.0,0.0451578,"However, overall beneficial effects of the PT for active forward flexion shoulder range of motion and shoulder function were found in both groups.
","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'De Groef', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Devoogdt', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Van Kampen', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Vergote', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Geraerts', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Dams', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Elien', 'Initials': 'E', 'LastName': 'Van der Gucht', 'Affiliation': 'Department of Rehabilitation Sciences, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Debeer', 'Affiliation': 'Department of Development and Regeneration, Orthopaedics, University Hospitals Leuven, Leuven, Belgium.'}]",European journal of cancer care,['10.1111/ecc.13175']
483,31571315,Physical activity preferences before and after participation in a 6-month physical activity intervention among women with metastatic breast cancer.,"OBJECTIVE


This secondary analysis of the ABLE Trial (ClinicalTrials.gov NCT03148886) aimed to assess physical activity preferences before and after a 6-month physical activity intervention for women recently diagnosed with metastatic breast cancer and to investigate demographic and clinical correlates of these preferences.
METHODS


Forty-nine patients participated in the ABLE Trial, a single-arm, unsupervised 6-month physical activity intervention with activity trackers. At baseline and 6 months, physical activity preferences, physical activity level, clinical variables, demographics and social vulnerability were assessed.
RESULTS


At baseline, 49 participants were included, among whom 85% were interested in receiving physical activity counselling and 89% were interested in following a physical activity programme designed for metastatic breast cancer. At the end of the study, more participants preferred practising in a community fitness centre (66%) rather than at home (19% vs. 44% at baseline, p = .03). A higher social vulnerability score and not being treated by chemotherapy at baseline were significantly associated with lower desire to receive physical activity counselling (p = .01 and p = .04 respectively).
CONCLUSIONS


This study will help design future studies within patients with metastatic breast cancer in accordance with their preferences. Designing tailored physical activity interventions according to the participant's preferences may be one key to success for adherence.",2020,"A higher social vulnerability score and not being treated by chemotherapy at baseline were significantly associated with lower desire to receive physical activity counselling (p = .01 and p = .04 respectively).
","['49 participants were included, among whom 85% were interested in receiving', 'Forty-nine patients participated in the ABLE Trial, a single-arm, unsupervised 6-month', 'women with metastatic breast cancer', 'patients with metastatic breast cancer in accordance with their preferences', 'women recently diagnosed with metastatic breast cancer']","['physical activity counselling', 'physical activity programme', 'physical activity intervention', 'physical activity intervention with activity trackers']","['physical activity preferences, physical activity level, clinical variables, demographics and social vulnerability', 'social vulnerability score', 'Physical activity preferences', 'physical activity preferences']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",49.0,0.0612507,"A higher social vulnerability score and not being treated by chemotherapy at baseline were significantly associated with lower desire to receive physical activity counselling (p = .01 and p = .04 respectively).
","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Delrieu', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology EA7424, University of Lyon, Villeurbanne, France.'}, {'ForeName': 'Jeff K', 'Initials': 'JK', 'LastName': 'Vallance', 'Affiliation': 'Faculty of Health Disciplines, Athabasca University, Athabasca, Alberta, Canada.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Morelle', 'Affiliation': 'Department of Clinical Research and Innovation, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Department of Cancer and Environment, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pialoux', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology EA7424, University of Lyon, Villeurbanne, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Cancer Control Alberta, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Dufresne', 'Affiliation': 'Department of Medical Oncology, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Department of Medical Oncology, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Pierre-Etienne', 'Initials': 'PE', 'LastName': 'Heudel', 'Affiliation': 'Department of Medical Oncology, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': 'Department of Medical Oncology, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Pérol', 'Affiliation': 'Department of Cancer and Environment, Leon Berard Cancer Center, Lyon, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Touillaud', 'Affiliation': 'Department of Cancer and Environment, Leon Berard Cancer Center, Lyon, France.'}]",European journal of cancer care,['10.1111/ecc.13169']
484,31961224,Response of Retinal Sensitivity to Intravitreal Anti-angiogenic Bevacizumab and Triamcinolone Acetonide for Patients with Diabetic Macular Edema over One Year.,"AIM


The aim of this study was to evaluate and compare microperimetry changes in patients with clinically significant diabetic macular edema secondary to diabetes mellitus, following intravitreal injections of bevacizumab or triamcinolone during a follow-up of 1 year after treatment.
MATERIALS AND METHODS


30 patients with clinically significant macular edema were randomized into two groups of 15 patients each. One group initially received three intravitreal injections of 2.5 mg bevacizumab at monthly intervals. The other received a single injection of 8 mg of triamcinolone followed by two sham interventions at monthly intervals. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured. Macular function was documented by microperimetry at baseline, 3, 6, 9 months and at the last visit of each patient.
RESULTS


In the bevacizumab group, the mean differential light threshold (±standard deviation) under therapy improved significantly from 8.40 (± 3.8) dB to 12.8 (±4.3) dB at the 12-month follow-up visit (p ≤ .05), whereas in the triamcinolone group it increased from 8.0 (± 2.4) dB at baseline to 9.3 (±3.6) dB at the last visit without reaching statistical significance ( p  > .05). The mean differential light thresholds between the two groups were not statistically significant at baseline or the last visit ( p  > .05). In the bevacizumab group, the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p ≤ .05).
CONCLUSION


Central macular function as measured by microperimetry in patients with acute DME improved in addition to anatomical restoration after intravitreal bevacizumab and triamcinolone injection. In our clinical study, the measures of the variables in patients receiving bevacizumab were superior to those receiving triamcinolone throughout the one-year observation period.",2020,"In the bevacizumab group the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p≤0.05).","['patients with diabetic macular edema over one year', 'patients with clinically significant diabetic macular edema secondary to diabetes mellitus', 'patients with acute DME', '30 patients with clinically significant macular edema']","['triamcinolone', 'bevacizumab', 'triamcinolone injection', 'Triamcinolone', 'intravitreal anti-angiogenic bevacizumab and triamcinolone acetonide', 'bevacizumab or triamcinolone']","['Macular function', 'mean differential light thresholds', 'mean differential light threshold', 'mean differential light threshold (±standard deviation) under therapy', 'Best-corrected visual acuity (BCVA) and central retinal thickness (CRT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema (disorder)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0641456', 'cui_str': 'DMES'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4529672', 'cui_str': 'Triamcinolone Injection [Zilretta]'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}]",30.0,0.0174961,"In the bevacizumab group the improvement (slope) in mean differential light threshold was significantly superior to the Triamcinolone group (Estimate = 0.588, p≤0.05).","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Mylonas', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schranz', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Scholda', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Karst', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reiter', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Baumann', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems, Section for Medical Statistics, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna , Vienna, Austria.'}]",Current eye research,['10.1080/02713683.2020.1712728']
485,31957152,Placebo-controlled dose-effect studies with topical minoxidil 2% or 5% in male-patterned hair loss treated with oral finasteride employing an analytical and exhaustive study protocol.,"BACKGROUND


Drug trials for male-pattern hair loss (MPHL) did not investigate hair cycling.
MATERIALS AND METHODS


Male-pattern hair loss volunteers (n = 22) took oral finasteride 1 mg daily with randomly either MTS5% or control lotion (1 mL/d). After 12 months on oral drug, 14 were randomized for a dose-effect study of topical minoxidil 2% or 5%. Each 3-month ""on-lotion"" was followed by a 3-month ""off-lotion.""
RESULTS


Exogen release and anagen initiation from pre-existing but functionally deficient follicles occurred mainly during combined dug treatment. Anagen initiation by topical minoxidil 5% could not be maintained by oral finasteride. As compared with control males, the compound index of hair growth raised from 30% at baseline up to 60% within 3 months of combined drug regimen which is better than oral drug only (no change) but still far beyond normalization of productivity (considered as 100%). There was no obvious transformation of miniaturized hair follicles into terminal hair-producing follicles, and the activation of miniaturized hair follicles was not clinically relevant (slow growth and short duration of anagen).
CONCLUSIONS


Benefit with oral finasteride and topical 5% minoxidil (1 mL, 1 per day) resulted from initiation of anagen in deficient terminal follicles without increased growth rates.",2020,"As compared with control males, the compound index of hair growth raised from 30% at baseline up to 60% within 3 months of combined drug regimen which is better than oral drug only (no change) but still far beyond normalization of productivity (considered as 100%).","['male-pattern hair loss (MPHL', 'Male-pattern hair loss volunteers (n\xa0=\xa022) took', 'male-patterned hair loss treated with']","['topical minoxidil', 'Placebo', 'MTS5% or control lotion', 'oral finasteride', 'minoxidil', 'oral finasteride 1\xa0mg daily with randomly']","['growth rates', 'compound index of hair growth raised']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C1607293', 'cui_str': 'Finasteride 1 MG [Propecia]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}]",,0.0611903,"As compared with control males, the compound index of hair growth raised from 30% at baseline up to 60% within 3 months of combined drug regimen which is better than oral drug only (no change) but still far beyond normalization of productivity (considered as 100%).","[{'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Van Neste', 'Affiliation': ""Skinterface and Brussels' Hair Clinic, Brussels, Belgium.""}]",Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI),['10.1111/srt.12827']
486,31941523,CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial.,"BACKGROUND


A substantial proportion of breast cancer patients develop metastatic disease, with over 450,000 deaths globally per year. Bone is the most common first site of metastatic disease accounting for 40% of all first recurrence and 70% of patients with advanced disease develop skeletal involvement. Treatment of bone metastases currently focusses on symptom relief and prevention and treatment of skeletal complications. However, there remains a need for further treatment options for patients with bone metastases. Combining systemic therapy with a bone-targeted agent, such as radium-223, may provide an effective treatment with minimal additional side effects.
METHODS/DESIGN


CARBON is a UK-based, open-label, multi-centre study which comprises an initial safety phase to establish the feasibility and safety of combining radium-223 given on a 6-weekly schedule in combination with orally administered capecitabine followed by a randomised extension phase to further characterise the safety profile and provide preliminary estimation of efficacy.
DISCUSSION


The CARBON study is important as the results will be the first to assess radium-223 with chemotherapy in advanced breast cancer. If the results find acceptable rates of toxicity with a decrease in bone turnover markers, further work will be necessary in a phase II/III setting to assess the efficacy and clinical benefit.
TRIAL REGISTRATION


ISRCTN, ISRCTN92755158, Registered on 17 February 2016.",2020,"If the results find acceptable rates of toxicity with a decrease in bone turnover markers, further work will be necessary in a phase II/III setting to assess the efficacy and clinical benefit.
","['patients with bone metastases', 'advanced breast cancer', 'breast cancer patients with BONe metastases (CARBON', 'ISRCTN92755158, Registered on 17 February 2016']","['capecitabine', 'CApecitabine plus Radium-223 (Xofigo™']",['bone turnover markers'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C3643595', 'cui_str': 'Xofigo'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",,0.076198,"If the results find acceptable rates of toxicity with a decrease in bone turnover markers, further work will be necessary in a phase II/III setting to assess the efficacy and clinical benefit.
","[{'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Rathbone', 'Affiliation': 'Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Flanagan', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendall', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK. J.E.Kendall@leeds.ac.uk.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Palmieri', 'Affiliation': 'Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'MacPherson', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}]",Trials,['10.1186/s13063-019-3643-6']
487,31941531,"High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN).","BACKGROUND


Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus. Neither pharmacological treatments nor low-frequency spinal cord stimulation (SCS) has provided significant and long-term pain relief for patients with PDN. This study aims to document the value of 10-kHz SCS in addition to conventional medical management (CMM) compared with CMM alone in patients with refractory PDN.
METHODS


In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10-kHz SCS combined with CMM or CMM alone after appropriate institutional review board approvals and followed for 24 months. Key inclusion criteria include (1) symptoms of PDN for at least 12 months, (2) average pain intensity of at least 5 cm-on a 0- to 10-cm visual analog scale (VAS)-in the lower limbs, and (3) an appropriate candidate for SCS. Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3 cm on VAS in the upper limbs or both. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. The primary endpoint comparing responder rates (≥50% pain relief) and safety rates between the treatment groups will be assessed at 3 months. Several secondary endpoints will also be reported on.
DISCUSSION


Enrollment commenced in 2017 and was completed in 2019. This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM.
TRIAL REGISTRATION


ClincalTrials.gov identifier: NCT03228420 (registered 24 July 2017).",2020,"This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM.
","['patients with PDN', 'patients with refractory PDN', '216 subjects with PDN', 'Key inclusion criteria include (1) symptoms of PDN for at least 12\u2009months, (2) average pain intensity of at least 5\u2009cm-on a 0- to 10-cm visual analog scale (VAS)-in the lower limbs, and (3) an appropriate candidate for SCS', 'painful diabetic neuropathy', 'Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3\u2009cm on VAS in the upper limbs or both']","['CMM alone', '10-kHz SCS', '10-kHz SCS combined with CMM or CMM', 'High-frequency spinal cord stimulation at 10\u2009kHz', 'conventional medical management (CMM']","['pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction', 'responder rates (≥50% pain relief) and safety rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0751074', 'cui_str': 'Diabetic Neuralgia'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017086', 'cui_str': 'Gangrene'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",216.0,0.304024,"This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM.
","[{'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Mekhail', 'Affiliation': 'Evidence-Based Pain Management Research, Cleveland Clinic, C25, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Argoff', 'Affiliation': 'Department of Neurology, Albany Medical College, MC 70, 47 New Scotland Avenue, Albany, NY, 12208, USA.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health and Well Being, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, Scotland, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Nasr', 'Affiliation': 'Department of Endocrinology & Metabolism, Cleveland Clinic, F20, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Caraway', 'Affiliation': 'Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA.'}, {'ForeName': 'Bradford E', 'Initials': 'BE', 'LastName': 'Gliner', 'Affiliation': 'Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Brooks', 'Affiliation': 'Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA. lisa.brooks@nevro.com.'}]",Trials,['10.1186/s13063-019-4007-y']
488,31941538,The cost-effectiveness of specialized nursing interventions for people with Parkinson's disease: the NICE-PD study protocol for a randomized controlled clinical trial.,"BACKGROUND


Current guidelines recommend that every person with Parkinson's disease (PD) should have access to Parkinson's disease nurse specialist (PDNS) care. However, there is little scientific evidence of the cost-effectiveness of PDNS care. This hampers wider implementation, creates unequal access to care, and possibly leads to avoidable disability and costs. Therefore, we aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS compared with usual care (without PDNS) for people with PD in all disease stages. To gain more insight into the deployed interventions and their effects, a preplanned subgroup analysis will be performed on the basis of disease duration (diagnosis < 5, 5-10, or > 10 years ago).
METHODS


We will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with PD who have not been treated by a PDNS over the past 2 years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to receive either care by a PDNS (who works according to a recent guideline on PDNS care) or usual care. We will use two co-primary outcomes: quality of life (measured with the Parkinson's Disease Questionnaire-39) and motor symptoms (measured with the Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III). Secondary outcomes include nonmotor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden, and coping skills. Data will be collected after 12 months and 18 months by a blinded researcher. A healthcare utilization and productivity loss questionnaire will be completed every 3 months.
DISCUSSION


The results of this trial will have an immediate impact on the current care of people with PD. We hypothesize that by offering more patients access to PDNS care, quality of life will increase. We also expect healthcare costs to remain equal because increases in direct medical costs (funding additional nurses) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care will be warranted.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03830190. Registered February 5, 2019 (retrospectively registered).",2020,"Secondary outcomes include nonmotor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden, and coping skills.","[""people with Parkinson's disease"", 'people with PD in all disease stages', 'people with PD', '240 people with PD who have not been treated by a PDNS over the past 2 years', 'eight community hospitals in the Netherlands', ""every person with Parkinson's disease (PD""]","['care by a PDNS (who works according to a recent guideline on PDNS care) or usual care', 'PDNS compared with usual care (without PDNS', 'specialized nursing interventions']","['cost-effectiveness', 'nonmotor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden, and coping skills', ""quality of life (measured with the Parkinson's Disease Questionnaire-39) and motor symptoms (measured with the Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale part III""]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0222045'}, {'cui': 'C0439070', 'cui_str': 'III'}]",240.0,0.137287,"Secondary outcomes include nonmotor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver burden, and coping skills.","[{'ForeName': 'Danique L M', 'Initials': 'DLM', 'LastName': 'Radder', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, PO Box 9101 (947), 6500, HB, Nijmegen, The Netherlands. danique.radder@radboudumc.nl.'}, {'ForeName': 'Herma H', 'Initials': 'HH', 'LastName': 'Lennaerts', 'Affiliation': 'Department of Neurology, Department of Anesthesiology, Pain and Palliative Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Vermeulen', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Thies', 'Initials': 'T', 'LastName': 'van Asseldonk', 'Affiliation': 'Department of Neurology, Elisabeth-TweeSteden Center, Tilburg, The Netherlands.'}, {'ForeName': 'Cathérine C S', 'Initials': 'CCS', 'LastName': 'Delnooz', 'Affiliation': 'Department of Neurology, Máxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Rob H', 'Initials': 'RH', 'LastName': 'Hagen', 'Affiliation': 'Patient Expert at the Dutch Parkinson Association, Bunnik, The Netherlands.'}, {'ForeName': 'Marten', 'Initials': 'M', 'LastName': 'Munneke', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, PO Box 9101 (947), 6500, HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, PO Box 9101 (947), 6500, HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, PO Box 9101 (947), 6500, HB, Nijmegen, The Netherlands.'}]",Trials,['10.1186/s13063-019-3926-y']
489,31958790,"Efficacy of Omalizumab in Mastocytosis: Allusive Indication Obtained from a Prospective, Double-Blind, Multicenter Study (XOLMA Study).","BACKGROUND


Patients with mastocytosis often suffer from a variety of symptoms caused by mast cell mediators where treatments remain difficult, showing various success rates. Omalizumab, a monoclonal anti-IgE antibody, has been postulated to have a positive impact on mastocytosis-associated symptoms such as flush, vertigo, gastrointestinal problems, or anaphylaxis.
OBJECTIVE


To investigate the efficacy and safety of omalizumab in systemic mastocytosis.
METHODS


Patients with histologically proven mastocytosis were investigated in a multicenter prospective double-blind placebo-controlled trial to receive either omalizumab or placebo, dosed according to IgE and body weight. The primary endpoint was change in the AFIRMM activity score after 6 months of treatment. Different laboratory parameters were analyzed.
RESULTS


Sixteen patients were analyzed: 7 to omalizumab and 9 to placebo (mean age 47.7 ± 13.8 vs. 45.4 ± 8.8 years; 66.6 vs. 85.7% were female; mean disease duration 10.0 ± 5.1 vs. 4.5 ± 2.9 years, respectively). After 6 months the median AFIRMM score decreased 50% from 52.0 to 26.0 in the omalizumab group versus 104.0-102.0 in the placebo group (p = 0.286); however, the difference was not significant (p = 0.941). Secondary endpoints, including the number of allergic reactions, changes in major complaints, wheal-and-flare reaction due to mechanical irritation (Darier's sign), and frequency of the use of mastocytosis-specific drugs improved in the omalizumab group, but not significantly. Adverse events like urticaria, bronchospasm, and anaphylactic shock showed no significant difference between the groups. No severe adverse events occurred. FcεRI (Fc-epsilon receptor) expression on basophils decreased after receiving omalizumab versus placebo.
CONCLUSION


Omalizumab was safe and showed a tendency to improve mastocytosis-related symptoms, in particular diarrhea, dizziness, flush, and anaphylactic reactions, including the AFIRMM score and secondary endpoints; however, the difference was not significant. Due to the small study size and difference at baseline between the study groups, further studies are required to confirm our findings.",2020,"Adverse events like urticaria, bronchospasm, and anaphylactic shock showed no significant difference between the groups.","['Sixteen patients were analyzed: 7 to omalizumab and 9 to placebo (mean age 47.7 ± 13.8 vs. 45.4 ± 8.8 years; 66.6 vs. 85.7% were female; mean disease duration 10.0 ± 5.1 vs. 4.5 ± 2.9 years, respectively', 'Patients with histologically proven mastocytosis']","['omalizumab or placebo', 'omalizumab', 'placebo', 'omalizumab versus placebo', 'Omalizumab', 'FcεRI']","['efficacy and safety', ""number of allergic reactions, changes in major complaints, wheal-and-flare reaction due to mechanical irritation (Darier's sign), and frequency of the use of mastocytosis-specific drugs"", 'median AFIRMM score', 'severe adverse events', 'mastocytosis-related symptoms, in particular diarrhea, dizziness, flush, and anaphylactic reactions', 'Adverse events like urticaria, bronchospasm, and anaphylactic shock', 'AFIRMM activity score']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0024899', 'cui_str': 'Mast Cell Activation Syndromes'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0221232', 'cui_str': 'Wheal'}, {'cui': 'C0429899', 'cui_str': 'Flare reaction (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1302810', 'cui_str': 'Mechanical irritation (morphologic abnormality)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0024899', 'cui_str': 'Mast Cell Activation Syndromes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0002792', 'cui_str': 'Anaphylactic Reaction'}, {'cui': 'C0042109', 'cui_str': 'Hives'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",16.0,0.178779,"Adverse events like urticaria, bronchospasm, and anaphylactic shock showed no significant difference between the groups.","[{'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland, meike.distler@usz.ch.'}, {'ForeName': 'Julia-Tatjana', 'Initials': 'JT', 'LastName': 'Maul', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Urs C', 'Initials': 'UC', 'LastName': 'Steiner', 'Affiliation': 'Department of Immunology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jandus', 'Affiliation': 'Division of Immunology and Allergology, Department of Medical Specialties, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Antonios G A', 'Initials': 'AGA', 'LastName': 'Kolios', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Murer', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Graf', 'Affiliation': 'Graf Biostatistics, Zurich, Switzerland.'}, {'ForeName': 'Jörg D', 'Initials': 'JD', 'LastName': 'Seebach', 'Affiliation': 'Division of Immunology and Allergology, Department of Medical Specialties, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Werner J', 'Initials': 'WJ', 'LastName': 'Pichler', 'Affiliation': 'Department of Rheumatology, Immunology and Allergology, University Hospital Berne, Berne, Switzerland.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Navarini', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lars E', 'Initials': 'LE', 'LastName': 'French', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Helbling', 'Affiliation': 'Department of Rheumatology, Immunology and Allergology, University Hospital Berne, Berne, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid-Grendelmeier', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Zurich, Switzerland.'}]","Dermatology (Basel, Switzerland)",['10.1159/000504842']
490,31102345,The efficacy and safety of topical 5% methimazole vs 4% hydroquinone in the treatment of melasma: A randomized controlled trial.,"BACKGROUND


The management of melasma is still challenging, and new treatment modalities with favorable side effect profile are required. Methimazole, a peroxidase inhibitor, seems to have a beneficial effect in the management of melasma but there is a paucity of studies for evaluation of its efficacy. This double-blinded trial was aimed to evaluate the efficacy and safety of methimazole vs hydroquinone 4% which is the gold standard treatment in the management of melasma.
METHODS


Fifty patients with melasma were enrolled and randomly divided into two groups to receive 4% hydroquinone or 5% methimazole once daily for 8 weeks. Forty patients completed the study. The clinical response was assessed at 4th, 8th, and 12th weeks after treatment by MASI score, patient satisfaction, and physician scores.
RESULTS


Both groups showed a reduction in the MASI score at the 8th week which was more significant in hydroquinone group but higher relapse rate was also observed in this group after discontinuing the drug. The side effects were similar between groups. Also, patient and physician satisfaction scores were also more in favor of hydroquinone 4%.
CONCLUSION


Methimazole could be an alternative treatment of melasma alone or in combination with other depigmenting drugs. Although not as effective as hydroquinone, the noncytotoxic and nonmutagenic aspects of methimazole may make it a promising alternative for the treatment of melasma.",2020,Both groups showed a reduction in the MASI score at the 8th week which was more significant in hydroquinone group but higher relapse rate was also observed in this group after discontinuing the drug.,"['Forty patients completed the study', 'Fifty patients with melasma', 'melasma']","['hydroquinone', 'Methimazole', 'hydroquinone or 5% methimazole', 'topical 5% methimazole vs 4% hydroquinone', 'methimazole vs hydroquinone']","['relapse rate', 'side effects', 'MASI score', 'MASI score, patient satisfaction, and physician scores', 'patient and physician satisfaction scores', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C0020307', 'cui_str': 'Quinols'}, {'cui': 'C0025644', 'cui_str': 'thiamazole'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.031146,Both groups showed a reduction in the MASI score at the 8th week which was more significant in hydroquinone group but higher relapse rate was also observed in this group after discontinuing the drug.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Gheisari', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Dadkhahfar', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Olamaei', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Moghimi', 'Affiliation': 'Department of Pharmaceutics and Nanotechnology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Niknejad', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Najar Nobari', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12987']
491,31948475,Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial.,"BACKGROUND


Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response. Due to the lack of high-quality clinical evidence, a randomized placebo-controlled trial is required to assess the efficacy and safety of JPSS.
METHODS/DESIGN


The efficacy and safety of JPSS herbal formula cream will be evaluated through a prospective, randomized, placebo-controlled trial conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. NSCLC patients with CRF will be randomized into two groups at a ratio of 1:1. Each group will receive either 15 g of the oral JPSS herbal formula cream or placebo twice a day from day 6 to day 20 during two courses of paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy. The primary endpoint is the difference in the degree of fatigue between baseline (the day before the start of the intervention) and day 42, which will be assessed by the Revised Piper Fatigue Scale score. The secondary endpoints are quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score. The toxicity of the treatments will also be evaluated at the same time. All outcomes will be measured at baseline, day 6, day 21, and day 42 of the treatment.
DISCUSSION


This randomized trial will investigate the efficacy and safety of JPSS applied for CRF in patients with NSCLC.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900023451. Registered on 28 May 2019.",2020,"A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response.","['patients with NSCLC', 'NSCLC patients with CRF', 'patients with non-small cell lung cancer', 'non-small cell lung cancer (NSCLC) patients', 'First Affiliated Hospital of Guangzhou University of Chinese Medicine']","['placebo', 'JPSS', 'Chemotherapy-related fatigue (CRF', 'Jianpishengsui (JPSS', 'JPSS herbal formula cream', 'paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy', 'oral JPSS herbal formula cream or placebo', 'Jianpishengsui']","['degree of fatigue', 'Revised Piper Fatigue Scale score', 'efficacy and safety', 'Efficacy and safety', 'quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.301108,"A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response.","[{'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Leihao', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Jietao', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, No.232 Waihuan Dong Road, Guangzhou, 510006, Guangdong, China.'}, {'ForeName': 'Xuewu', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Science and Health,Chinese Medicine Centre, Western Sydney University, Penrith, NSW, Australia.'}, {'ForeName': 'Chiahshean', 'Initials': 'C', 'LastName': 'Teo', 'Affiliation': 'Traditional & Complementary Unit, National Cancer Institute, 4, Jalan P7, Presint 7, 62250, Putrajaya, Malaysia.'}, {'ForeName': 'Lizhu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Oncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, Guangdong, China. lizhulin26@yahoo.com.'}]",Trials,['10.1186/s13063-019-3982-3']
492,31856460,A comparative study of tarsorrhaphy and amniotic membrane transplantation in the healing of persistent corneal epithelial defects.,"Purpose


To compare and study the clinical outcome of tarsorrhaphy and amniotic membrane transplant in the healing of persistent corneal epithelial defects in terms of clinical improvement and symptomatic relief.
Methods


This was an interventional, prospective study in which a total of 60 patients with persistent epithelial defects (PED's), randomly divided into two groups of 30 patients each who underwent tarsorrhaphy (Group A) or amniotic membrane transplantation (Group B) with a 4-week-follow-up period, were included. The main parameters studied were the size of an epithelial defect, total healing time, pain score, and complications.
Results


The study included 60 eyes of 60 patients with PED. The healing time was 9.83 ± 6.51 days in Group A (median = 9.50 days, IQR = 1-7 days) vs. 18.33 ± 13.46 days (median = 19.50 days, IQR = 1-21 days) in Group B. A total of ten eyes (16.7%) did not heal at the end of 4 weeks.
Conclusion


There was a significant reduction in the area of epithelial defect at the end of the 1 week and 2 week follow up postoperatively, in both the treatment forms. The mean healing time in patients of Group A was less as compared to that of the patients in Group B.",2020,"There was a significant reduction in the area of epithelial defect at the end of the 1 week and 2 week follow up postoperatively, in both the treatment forms.","['60 eyes of 60 patients with PED', ""60 patients with persistent epithelial defects (PED's""]","['tarsorrhaphy (Group A) or amniotic membrane transplantation', 'tarsorrhaphy and amniotic membrane transplantation', 'tarsorrhaphy and amniotic membrane transplant']","['healing time', 'size of an epithelial defect, total healing time, pain score, and complications', 'mean healing time', 'area of epithelial defect']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0005746', 'cui_str': 'Suture of palpebral fissure'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0002630', 'cui_str': 'Amniotic Membrane'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",60.0,0.0280001,"There was a significant reduction in the area of epithelial defect at the end of the 1 week and 2 week follow up postoperatively, in both the treatment forms.","[{'ForeName': 'Hennaav K', 'Initials': 'HK', 'LastName': 'Dhillon', 'Affiliation': 'Department of Ophthalmology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Bahadur', 'Affiliation': 'Department of Ophthalmology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'Department of Ophthalmology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_617_19']
493,31918748,"The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in patients with coloreactal cancer: study protocol for a single-blinded, randomized sham-controlled trial.","BACKGROUND


Colorectal cancer is the most common cancer in Hong Kong. Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer. However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine. This study aims to examine the efficacy and safety of acupuncture for alleviating CIPN in patients with colorectal cancer in Hong Kong.
METHODS/DESIGN


This is a single-blinded, randomized, sham-controlled efficacy trial. Eighty-four eligible patients, who are Hong Kong Chinese, aged ≥ 18 years, diagnosed with colorectal cancer and undergoing oxaliplatin-based chemotherapy, will be randomized in a ratio of 1:1 to the electro-acupuncture group or the sham-controlled group. During a 12-week treatment period, patients in the electro-acupuncture group will undergo electro-acupuncture once a week from the first cycle of chemotherapy, while patients in the control group will receive sham acupuncture, and the patients in both groups will be followed up for 12 weeks. The primary outcome measure is the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire. The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ).
DISCUSSION


The study will compare electro-acupuncture with sham acupuncture to explore the feasibility for electro-acupuncture in improving symptoms caused by chemotherapy-induced peripheral neuropathy.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03582423. Registered on 11 July 2018.",2020,"The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ).
","['Eighty-four eligible patients, who are Hong Kong Chinese, aged ≥\u200918\u2009years, diagnosed with colorectal cancer and undergoing', 'patients with coloreactal cancer', 'advanced and metastatic colorectal cancer', 'patients with colorectal cancer in Hong Kong']","['Oxaliplatin-based chemotherapy', 'electro-acupuncture', 'electro-acupuncture group will undergo electro-acupuncture', 'oxaliplatin-based chemotherapy', 'Acupuncture', 'control group will receive sham acupuncture', 'electro-acupuncture with sham acupuncture', 'oxaliplatin', 'acupuncture']","['numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ', 'efficacy and safety', 'Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOC-Ntx) questionnaire']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0222045'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0009807', 'cui_str': 'Constitutions'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}]",84.0,0.33645,"The secondary outcome measures include numerical rating scale (NRS) for numbness/pain, vibration and light touch sense test, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Constitution of Chinese Medicine Questionnaire (CCMQ).
","[{'ForeName': 'Kaiyin', 'Initials': 'K', 'LastName': 'Chan', 'Affiliation': 'Yan Chai Hospital cum Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre, Ha Kwai Chung, Hong Kong SAR.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Lui', 'Affiliation': 'Oncology Department of Princess Margaret Hospital, Kwai Chung, Hong Kong SAR.'}, {'ForeName': 'Kaling', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Yan Chai Hospital cum Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre, Ha Kwai Chung, Hong Kong SAR.'}, {'ForeName': 'Kwongwai', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Yan Chai Hospital cum Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre, Ha Kwai Chung, Hong Kong SAR.'}, {'ForeName': 'Manchi', 'Initials': 'M', 'LastName': 'Lai', 'Affiliation': 'Yan Chai Hospital cum Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre, Ha Kwai Chung, Hong Kong SAR.'}, {'ForeName': 'Waiwai', 'Initials': 'W', 'LastName': 'Lau', 'Affiliation': 'Yan Chai Hospital cum Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre, Ha Kwai Chung, Hong Kong SAR.'}, {'ForeName': 'Bacon', 'Initials': 'B', 'LastName': 'Ng', 'Affiliation': 'Chinese Medicine Department, Hong Kong Hospital Authority, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Linda L D', 'Initials': 'LLD', 'LastName': 'Zhong', 'Affiliation': 'Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, Jockey Club School of Chinese Building, 7 Baptist Road, Kowloon Tong, Hong Kong SAR. ldzhong@hkbu.edu.hk.'}, {'ForeName': 'Zhao-Xiang', 'Initials': 'ZX', 'LastName': 'Bian', 'Affiliation': 'Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, Jockey Club School of Chinese Building, 7 Baptist Road, Kowloon Tong, Hong Kong SAR. bzxiang@hkbu.edu.hk.'}]",Trials,['10.1186/s13063-019-3972-5']
494,31918761,Evaluation of the safety and tolerability of a nutritional Formulation in patients with ANgelman Syndrome (FANS): study protocol for a randomized controlled trial.,"BACKGROUND


Ketogenic and low-glycemic-index diets are effective in treating drug-resistant seizures in children with Angelman syndrome. Cognition, mobility, sleep, and gastrointestinal health are intrinsically linked to seizure activity and overall quality of life. Ketogenic and low-glycemic diets restrict carbohydrate consumption and stabilize blood glucose levels. The ketogenic diet induces ketosis, a metabolic state where ketone bodies are preferentially used for fuel. The use of exogenous ketones in promoting ketosis in Angelman syndrome has not been previously studied. The study formulation evaluated herein contains the exogenous ketone beta-hydroxybutyrate to rapidly shift the body towards ketosis, resulting in enhanced metabolic efficiency.
METHODS/DESIGN


This is a 16-week, randomized, double-blind, placebo-controlled, crossover study to assess the safety and tolerability of a nutritional formula containing exogenous ketones. It also examines the potential for exogenous ketones to improve the patient's nutritional status which can impact the physiologic, symptomatic, and health outcome liabilities of living with Angelman syndrome.
DISCUSSION


This manuscript outlines the rationale for a study designed to be the first to provide data on nutritional approaches for patients with Angelman syndrome using exogenous ketones.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03644693. Registered on 23 August 2018. Last updated on 23 August 2018.",2020,"BACKGROUND


Ketogenic and low-glycemic-index diets are effective in treating drug-resistant seizures in children with Angelman syndrome.","['children with Angelman syndrome', 'patients with ANgelman Syndrome (FANS', 'patients with Angelman syndrome using exogenous ketones']","['nutritional Formulation', 'nutritional formula containing exogenous ketones', 'exogenous ketones', 'placebo', 'Ketogenic and low-glycemic-index diets']","['safety and tolerability', 'Cognition, mobility, sleep, and gastrointestinal health', 'seizure activity and overall quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162635', 'cui_str': 'Puppet Children'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}]",,0.0568724,"BACKGROUND


Ketogenic and low-glycemic-index diets are effective in treating drug-resistant seizures in children with Angelman syndrome.","[{'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Herber', 'Affiliation': 'Disruptive Nutrition, LLC, 300 West Morgan Street, Suite 1510, Durham, NC, 27701, USA.'}, {'ForeName': 'Edwin J', 'Initials': 'EJ', 'LastName': 'Weeber', 'Affiliation': 'PTC Therapeutics, Inc., 100 Corporate Court, South Plainfield, NJ, 07080-2449, USA.'}, {'ForeName': 'Dominic P', 'Initials': 'DP', 'LastName': ""D'Agostino"", 'Affiliation': 'Morsani College of Medicine, Department of Molecular Pharmacology and Physiology, University of South Florida, 12901 Bruce B Downs Blvd, Tampa, FL, 33612, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Duis', 'Affiliation': 'Division of Medical Genetics & Genomic Medicine, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, 37232-2578, USA. jessica.duis@vumc.org.'}]",Trials,['10.1186/s13063-019-3996-x']
495,31931853,Efficacy and safety of Guhong injection for treating coronary microvascular disease: study protocol for a randomized controlled trial.,"BACKGROUND


Coronary microvascular disease (CMVD) can be described as one of the cardiovascular diseases with normal coronary angiography but evidence of myocardial ischemia or microcirculatory lesions, often presenting as angina pectoris attacks. Coronary artery microtubular dysfunction is one of the pathogenic features of coronary heart disease, but its occurrence and development and the current CMVD-intervention therapy needs further research. Chinese traditional medicine (TCM) has advantages for the treatment of cardiovascular diseases. Hence, this article describes an ongoing randomized controlled clinical trial based on the theory of TCM for the purpose of evaluating the efficacy and safety of Guhong injection versus placebo in patients with CMVD.
METHODS/DESIGN


This is a multicenter, randomized, parallel-arm, open-label, double-blind, placebo-controlled clinical trial. A total of 260 eligible patients will be allocated and randomly assigned, in a ratio of 1:1, to either the experimental group or the control group. The treatment course is 10 consecutive days, and with an 8-week follow-up. The primary outcome is therapeutic efficacy. Secondary outcomes include the quantitative score of TCM syndromes (a series of TCM symptoms and signs of coronary heart disease), the average frequency of anginal attacks, electrocardiogram (ECG) changes, inflammatory response, endothelial function indicators and myocardial metabolites.
DISCUSSION


This trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results should provide high-quality evidence on the efficacy and safety of Guhong injection in the treatment of CMVD.
TRIAL REGISTRATION


Chinese Clinical Trials Registry, ID: ChiCTR1900022902. Registered on 27 April 2019.",2020,"Secondary outcomes include the quantitative score of TCM syndromes (a series of TCM symptoms and signs of coronary heart disease), the average frequency of anginal attacks, electrocardiogram (ECG) changes, inflammatory response, endothelial function indicators and myocardial metabolites.
","['patients with CMVD', '260 eligible patients']","['placebo', 'Guhong injection versus placebo', 'TCM', 'Guhong injection', 'Chinese traditional medicine (TCM']","['therapeutic efficacy', 'Efficacy and safety', 'efficacy and safety', 'quantitative score of TCM syndromes (a series of TCM symptoms and signs of coronary heart disease), the average frequency of anginal attacks, electrocardiogram (ECG) changes, inflammatory response, endothelial function indicators and myocardial metabolites']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4549688', 'cui_str': 'guhong'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0235462', 'cui_str': 'Angina attack'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",260.0,0.197001,"Secondary outcomes include the quantitative score of TCM syndromes (a series of TCM symptoms and signs of coronary heart disease), the average frequency of anginal attacks, electrocardiogram (ECG) changes, inflammatory response, endothelial function indicators and myocardial metabolites.
","[{'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Jieqin', 'Affiliation': 'The Second Clinical Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Shuling', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510006, Guangdong Province, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Hairong', 'Affiliation': 'The Second Clinical Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Xingzhen', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510006, Guangdong Province, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yanhong', 'Affiliation': 'The Second Clinical Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zilin', 'Affiliation': 'The Second Clinical Medical College of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510405, Guangdong Province, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Bojun', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510006, Guangdong Province, China. 1198039070@qq.com.'}]",Trials,['10.1186/s13063-019-3990-3']
496,31931855,Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I.,"BACKGROUND


This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN.
METHODS/DESIGN


Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance.
DISCUSSION


As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.",2020,We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN.,"['people with diabetic peripheral neuropathy (DPN', '62 patients with DPN', 'Footcare (FOCA) trial', 'people with diabetic neuropathy', 'people with DPN']","['customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD', 'control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD', 'Diabetic Foot Guidance System (SOPeD']","['foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance', 'DPN symptoms and severity classification']","[{'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011882', 'cui_str': 'Diabetic Neuropathies'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0454370', 'cui_str': 'Foot exercises (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}]",,0.129607,We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN.,"[{'ForeName': 'J S S P', 'Initials': 'JSSP', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Cruvinel Junior', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'E Q', 'Initials': 'EQ', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Veríssimo', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Monteiro', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'E Y', 'Initials': 'EY', 'LastName': 'Suda', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Sartor', 'Affiliation': 'Department of Physical Therapy, Ibirapuera University, São Paulo, SP, Brazil.'}, {'ForeName': 'I C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil. icnsacco@usp.br.'}]",Trials,['10.1186/s13063-019-4017-9']
497,31963163,"Low Plasma Appearance of (+)-Catechin and (-)-Catechin Compared with Epicatechin after Consumption of Beverages Prepared from Nonalkalized or Alkalized Cocoa-A Randomized, Double-Blind Trial.","Flavan-3-ols are claimed to be responsible for the cardioprotective effects of cocoa. Alkalized cocoa powder (ALC), commonly used for many non-confectionary products, including beverages, provides less (+)-catechin, (-)-epicatechin, and procyanidins and more (-)-catechin than nonalkalized cocoa powder (NALC). This may affect the plasma appearance of monomeric flavan-3-ol stereoisomers after consumption of NALC vs. ALC. Within a randomized, crossover trial, 12 healthy nonsmokers ingested a milk-based cocoa beverage providing either NALC or ALC. Blood was collected before and within 6 h postconsumption. (+)-Catechin, (-)-catechin, and epicatechin were analyzed in plasma by HPLC as sum of free and glucuronidated metabolites. Pharmacokinetic parameters were obtained by a one-compartment model with nonlinear regression methods. For epicatechin in plasma, total area under the curve within 6 h postconsumption ( AUC 0-6h ) and incremental  AUC 0-6h  were additionally calculated by using the linear trapezoidal method. After consumption of NALC and ALC, (+)-catechin and (-)-catechin were mostly not detectable in plasma, in contrast to epicatechin. For epicatechin, total  AUC 0-6h  was different between both treatments, but not incremental  AUC 0-6h . Most kinetic parameters were similar for both treatments, but they varied strongly between individuals. Thus, epicatechin is the main monomeric flavan-3-ol in plasma after cocoa consumption. Whether NALC should be preferred against ALC due to its higher (-)-epicatechin content remains unclear with regard to the results on incremental  AUC 0-6h . Future studies should investigate epicatechin metabolites in plasma for a period up to 24 h in a larger sample size, taking into account genetic polymorphisms in epicatechin metabolism and should consider all metabolites to understand inter-individual differences after cocoa intake.",2020,"After consumption of NALC and ALC, (+)-catechin and (-)-catechin were mostly not detectable in plasma, in contrast to epicatechin.",['12 healthy nonsmokers ingested a milk-based cocoa beverage providing either NALC or ALC'],"['Alkalized cocoa powder (ALC', 'NALC', 'Catechin, (-)-catechin, and', 'Catechin and (-)-Catechin Compared with Epicatechin after Consumption of Beverages Prepared from Nonalkalized or Alkalized Cocoa', 'NALC vs. ALC']",['Low Plasma Appearance of '],"[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0009209', 'cui_str': 'Cocoa Powder'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0014485', 'cui_str': '(2R,3R)-2-(3,4-Dihydroxyphenyl)-3,5,7-chromanetriol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}]",12.0,0.055351,"After consumption of NALC and ALC, (+)-catechin and (-)-catechin were mostly not detectable in plasma, in contrast to epicatechin.","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Ellinger', 'Affiliation': 'Faculty of Food, Nutrition and Hospitality Sciences, Hochschule Niederrhein, University of Applied Sciences, Rheydter Str. 277, 41065 Mönchengladbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reusch', 'Affiliation': 'Institute of Nutritional and Food Sciences, Nutritional Physiology, University of Bonn, Nußallee 9, 53115 Bonn, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Henckes', 'Affiliation': 'Institute of Nutritional and Food Sciences, Food Sciences, University of Bonn, Endenicher Allee 11-13, 53115 Bonn, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ritter', 'Affiliation': 'Institute of Nutritional and Food Sciences, Food Sciences, University of Bonn, Endenicher Allee 11-13, 53115 Bonn, Germany.'}, {'ForeName': 'Benno F', 'Initials': 'BF', 'LastName': 'Zimmermann', 'Affiliation': 'Institute of Nutritional and Food Sciences, Food Sciences, University of Bonn, Endenicher Allee 11-13, 53115 Bonn, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Ellinger', 'Affiliation': 'Department of Urology and Children Urology, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127 Bonn, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Galensa', 'Affiliation': 'Institute of Nutritional and Food Sciences, Food Sciences, University of Bonn, Endenicher Allee 11-13, 53115 Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stehle', 'Affiliation': 'Institute of Nutritional and Food Sciences, Nutritional Physiology, University of Bonn, Nußallee 9, 53115 Bonn, Germany.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Helfrich', 'Affiliation': 'Institute of Numerical Simulation, University of Bonn, Endenicher Allee 60, 53115 Bonn, Germany.'}]",Nutrients,['10.3390/nu12010231']
498,31957555,"Effects of vitamin D3 supplementation for 12 weeks on serum levels of anabolic hormones, anaerobic power, and aerobic performance in active male subjects: A randomized, double-blind, placebo-controlled trial.","Maintenance of the serum 25-hydroxyvitamin D (25-OH-D) concentration at recommended levels is essential due to its role in the regulation of anabolic hormones and athletic performance. However, the results of the clinical experiments in athletes are controversial. The present study aimed to investigate the effect of vitamin D3 supplement on serum levels of anabolic hormones, cortisol, anaerobic and aerobic performance in active males. In this double-blind, randomized controlled trial, 46 active males randomly assigned to vitamin D3 supplement (VDS; 2000 IU/day) or placebo for 12 weeks. The Wingate test, VO 2 max, and serum levels of 25-OH-D, Parathyroid hormone (PTH), total testosterone, growth hormone (GH), Insulin-like growth factor-1 (IGF-1), and cortisol were assessed. Subjects in the VDS group had a higher serum level of 25-OH-D ( p  = 0.004), VO 2 max ( p  = 0.016), and average power ( p  = 0.044) compared to the placebo at the end of the study. Also, lower levels of PTH ( p  = 0.004) and fatigue index ( p  < 0.001) were observed in VDS group at the end of the study. The serum cortisol levels were reduced significantly only in subjects with vitamin D deficiency in VDS group ( p  = 0.042). There was a significant reduction in serum testosterone levels in VDS group ( p  = 0.013). No change was indicated in serum levels of GH and IGF-1 in VDS group compared to the placebo ( p  > 0.05). The present study showed an improvement in aerobic capacity, anaerobic performance, and vitamin D status following vitamin D3 supplementation. However, more studies are required for the effect of vitamin D3 on serum concentration of anabolic hormones.",2020,No change was indicated in serum levels of GH and IGF-1 in VDS group compared to the placebo ( p  > 0.05).,"['46 active males randomly assigned to', 'active males', 'active male subjects']","['placebo', 'vitamin D3 supplement (VDS; 2000 IU/day) or placebo', 'vitamin D3 supplement', 'vitamin D3', 'vitamin D3 supplementation']","['aerobic capacity, anaerobic performance, and vitamin D status', 'serum 25-hydroxyvitamin D (25-OH-D) concentration', 'lower levels of PTH', 'serum cortisol levels', 'serum levels of GH and IGF-1', 'serum level of 25-OH-D', 'serum levels of anabolic hormones, cortisol, anaerobic and aerobic performance', 'serum testosterone levels', 'Wingate test, VO 2 max, and serum levels of 25-OH-D, Parathyroid hormone (PTH), total testosterone, growth hormone (GH), Insulin-like growth factor-1 (IGF-1), and cortisol', 'serum levels of anabolic hormones, anaerobic power, and aerobic performance', 'fatigue index']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.359525,No change was indicated in serum levels of GH and IGF-1 in VDS group compared to the placebo ( p  > 0.05).,"[{'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Ramezani Ahmadi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Exercise Physiology, Faculty of sports sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi Angali', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Internal Medicine, Golestan Hospital & Diabetes Research Center, Research Institute of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",European journal of sport science,['10.1080/17461391.2020.1713218']
499,31587493,"Acne treatment efficacy of intense pulsed light photodynamic therapy with topical licochalcone A, l-carnitine, and decanediol: A spilt-face, double-blind, randomized controlled trial.","BACKGROUND


Depending on disease severity, standard acne treatments can vary from topical to systemic therapy. However, poor compliance caused by adverse events and antibiotic resistance is a major cause of treatment failure.
AIMS


To determine the effectiveness of photodynamic therapy (PDT) with intense pulsed light (IPL) in the treatment of acne when combined with a cream containing licochalcone A, L-carnitine and decanediol (so-called, 'active formulation') versus PDT alone.
PATIENTS/METHODS


Twenty-nine volunteers, aged 21-39 years (26 women and 3 men, mean age 29.41 ± 5.24 years), with mild to severe facial acne, were enrolled. Each subject's face sides were randomized in a split-face manner to either receive PDT (IPL with a 400-720 nm cut-off filter, at 4 sessions with two-week intervals) combined with the active formulation cream twice daily for 10 weeks on one face side; or PDT and the vehicle cream on the other side, with the same treatment protocol. Reduction in acne quantity, melanin index and erythema index were assessed 2 weeks after the second treatment (day 28), 1 week after the fourth treatment (day 49), and 1 month after the fourth treatment (day 70).
RESULTS


Compared to baseline, patients in the active formulation group demonstrated a faster onset of reduction in the number of lesions at 2 weeks after the second treatment (p=0.010 for inflammatory acne and p=0.001 for non-inflammatory acne). A significantly greater reduction in lesion count was observed in the active formulation group compared with the vehicle group at all timepoints of evaluation for noninflammatory acne (day 28, day 49, and day 70; p=0.003, 0.005 and 0.002 respectively), and at 1 month after the fourth treatment for inflammatory acne (p=0.036). Compared to the vehicle group, the melanin index of the active formulation group decreased significantly at 1 month after the fourth treatment (p=0.015).
CONCLUSION


PDT is more effective in treating acne when combined with a topical cream containing licochalcone A, L-carnitine and decanediol, than PDT alone. Significant acne reduction and improvements in post-inflammatory hyperpigmentation were observed, which offers acne patients a better therapeutic option. It is a safe and effective combination treatment for patients with moderate and severe acne.",2020,"A significantly greater reduction in lesion count was observed in the active formulation group compared with the vehicle group at all timepoints of evaluation for noninflammatory acne (day 28, day 49, and day 70; p=0.003, 0.005 and 0.002 respectively), and at 1 month after the fourth treatment for inflammatory acne (p=0.036).","['Twenty-nine volunteers, aged 21-39 years (26 women and 3 men', 'patients with moderate and severe acne', ' mean age 29.41 ± 5.24 years), with mild to severe facial acne, were enrolled']","['PDT (IPL', 'intense pulsed light photodynamic therapy with topical licochalcone A, l-carnitine, and decanediol', 'photodynamic therapy (PDT) with intense pulsed light (IPL', 'PDT and the vehicle cream', 'L-carnitine and decanediol', 'licochalcone']","['post-inflammatory hyperpigmentation', 'lesion count', 'melanin index', 'acne quantity, melanin index and erythema index', 'adverse events and antibiotic resistance', 'inflammatory acne', 'number of lesions']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0125821', 'cui_str': '(2E)-3-(5-(1,1-dimethyl-2-propenyl)-4-hydroxy-2-methoxyphenyl)-1-(4-hydroxyphenyl)-2-propen-1-one'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0025196', 'cui_str': 'Melanins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance, Microbial'}, {'cui': 'C1998083', 'cui_str': 'Inflammatory acne'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions (observable entity)'}]",29.0,0.0702904,"A significantly greater reduction in lesion count was observed in the active formulation group compared with the vehicle group at all timepoints of evaluation for noninflammatory acne (day 28, day 49, and day 70; p=0.003, 0.005 and 0.002 respectively), and at 1 month after the fourth treatment for inflammatory acne (p=0.036).","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nudpanuda', 'Initials': 'N', 'LastName': 'Tavechodperathum', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Panittra', 'Initials': 'P', 'LastName': 'Suphatsathienkul', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13178']
500,31825141,Patient-based cost-effectiveness analysis of FOLFIRI versus FOLFOX7 for advanced gastric adenocarcinoma in China: A 4-year prospective randomised phase II study.,"BACKGROUND


Using data from the 4-year follow-up results of an open, randomised, phase II study, this patient-based cost-effectiveness analysis compares mFOLFIRI (irinotecan, 5-fluorouracil and leucovorin, the IRI arm) with mFOLFOX7 (oxaliplatin, 5-fluorouracil and leucovorin, the OXA arm) as first-line treatments in patients with locally advanced gastric adenocarcinoma (GC).
METHODS


A Markov model was created based on previous results reported at the 2016 Gastrointestinal Cancers Symposium to evaluate mFOLFIRI and mFOLFOX7 for advanced GC quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) were examined as the primary outcomes.
RESULTS


For the evaluable 128 patients, treatment efficacy was 0.59 QALYs for the IRI arm and 0.70 QALYs for the OXA arm, with a total cost of $13,861.34 for the IRI arm and $14,127.30 for the OXA arm. Hence, the ICER was $2,417.82 per QALY the OXA arm, which was below the threshold of 3 × per capita GDP of China. For subgroup analysis of those receiving mFOLFIRI followed by mFOLFOX7 (the IRI arm) and the reverse (the OXA arm), the OXA arm gained 0.44 more QALYs than the IRI arm with a total cost of $28,890.09 for the IRI arm and $31,147.30 for the OXA arm. However, the cost per QALY was also lower for the OXA arm than for the IRI arm, and the cost per QALY gained was $5,129.55 (below the Chinese WTP).
CONCLUSION


mFOLFOX7 is a very high cost-effective alternative as the first-line treatment for those patients with advanced GC compared with mFOLFIRI.",2020,"Hence, the ICER was $2,417.82 per QALY the OXA arm, which was below the threshold of 3 × per capita GDP of China.","['patients with locally advanced gastric adenocarcinoma (GC', 'advanced gastric adenocarcinoma in China']","['mFOLFIRI (irinotecan, 5-fluorouracil and leucovorin, the IRI arm) with mFOLFOX7 (oxaliplatin, 5-fluorouracil and leucovorin', 'FOLFIRI versus FOLFOX7']","['advanced GC quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'ICER', 'cost per QALY', 'total cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",128.0,0.0224385,"Hence, the ICER was $2,417.82 per QALY the OXA arm, which was below the threshold of 3 × per capita GDP of China.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Department of Medical Oncology, West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Hanrui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Sichuan, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Sichuan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Sichuan, China.'}, {'ForeName': 'Hongdou', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Sichuan, China.'}, {'ForeName': 'Kexun', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Sichuan, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Bi', 'Affiliation': 'Department of Medical Oncology, West China Hospital, Sichuan University, Sichuan, China.'}]",European journal of cancer care,['10.1111/ecc.13196']
501,31924275,Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial.,"BACKGROUND


Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this.
METHODS/DESIGN


The online 'Complaint Directed Mini-Interventions' (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline.
DISCUSSION


This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care.
TRIAL REGISTRATION


Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.",2020,"The online 'Complaint Directed Mini-Interventions' (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse.","['patients with a lower socioeconomic status', 'general practice nurses (GP nurses', '228 patients will be included in the study']","['NL6595', 'Implementing complaint-directed mini-interventions', 'SES-sensitive implementation strategy']","['participation rate (completing at least one face-to-face session and two online exercises', 'implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0498979,"The online 'Complaint Directed Mini-Interventions' (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse.","[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Leone', 'Affiliation': 'Department of Public Mental Health, Trimbos Institute: Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands. sleone@trimbos.nl.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lokman', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Boon', 'Affiliation': 'Academy Het Dorp, Arnhem, The Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'van der Poel', 'Affiliation': 'Academy Het Dorp, Arnhem, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Department of Public Mental Health, Trimbos Institute: Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Zijlstra-Vlasveld', 'Affiliation': 'ZonMw, the Netherlands Organisation for Health Research and Development, The Hague, The Netherlands.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Smeets', 'Affiliation': 'Academy Het Dorp, Arnhem, The Netherlands.'}]",Trials,['10.1186/s13063-019-3890-6']
502,31915035,Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a randomized controlled trial protocol.,"BACKGROUND


An increasing number of children are suffering from brain damage-related visual processing dysfunctions (VPD). There is currently a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually adaptive, and is paired with quantitative outcome assessments. Our aim is to investigate the effectiveness of this first visual intervention program for young children with (a risk of) VPD.
METHODS


This is a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care, which involves an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consists of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to the specific needs of the child). Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA) or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention).
DISCUSSION


Through this randomized controlled trial we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to a child's specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life.
TRIAL REGISTRATION


Netherlands Trial Register: NTR6952. Registered 19 January 2018.",2020,"The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD.","['100 children born very or extremely preterm (<\u200930\u2009weeks) at 1\u2009year of corrected age (CA), of whom 50% are expected to have VPD', 'young children with (a risk of) VPD', 'children at risk of visual processing dysfunctions from 1 year of age']","['NTR6952', 'placebo', 'new and early visual intervention program', 'early visual intervention', 'visual intervention program']",[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],100.0,0.24713,"The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD.","[{'ForeName': 'Marlou J G', 'Initials': 'MJG', 'LastName': 'Kooiker', 'Affiliation': 'Department of Neuroscience, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands. m.kooiker@erasmusmc.nl.'}, {'ForeName': 'Yoni', 'Initials': 'Y', 'LastName': 'van der Linden', 'Affiliation': 'Royal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, the Hague, The Netherlands.'}, {'ForeName': 'Jenneke', 'Initials': 'J', 'LastName': 'van Dijk', 'Affiliation': 'Royal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, the Hague, The Netherlands.'}, {'ForeName': 'Ymie J', 'Initials': 'YJ', 'LastName': 'van der Zee', 'Affiliation': 'Royal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, Rotterdam, The Netherlands.'}, {'ForeName': 'Renate M C', 'Initials': 'RMC', 'LastName': 'Swarte', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Liesbeth S', 'Initials': 'LS', 'LastName': 'Smit', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Sanny', 'Initials': 'S', 'LastName': 'van der Steen-Kant', 'Affiliation': 'Royal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, Huizen, The Netherlands.'}, {'ForeName': 'Sjoukje E', 'Initials': 'SE', 'LastName': 'Loudon', 'Affiliation': ""Department of Pediatric Ophthalmology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Kuyper', 'Affiliation': 'Royal Dutch Visio, Center of Expertise for Blind and Partially Sighted People, Rotterdam, The Netherlands.'}, {'ForeName': 'Johan J M', 'Initials': 'JJM', 'LastName': 'Pel', 'Affiliation': 'Department of Neuroscience, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'van der Steen', 'Affiliation': 'Department of Neuroscience, Erasmus Medical Center, PO Box 2040, 3000, CA, Rotterdam, The Netherlands.'}]",Trials,['10.1186/s13063-019-3936-9']
503,31961756,Ability of Layperson Callers to Apply a Tourniquet Following Protocol-Based Instructions From an Emergency Medical Dispatcher.,"Introduction : One of the greatest casualty-care improvements resulting from US military operations in Iraq and Afghanistan has been the reduction of preventable death from massive extremity hemorrhage - largely due to the widespread use of limb tourniquets. More recently, tourniquet use in civilian, prehospital settings has shown promise in reducing deaths in cases of catastrophic arterial limb hemorrhage. Telephone instructions by trained emergency medical dispatchers (EMDs) on applying an available tourniquet may help achieve such a benefit. Objectives : The objective of the study was to determine whether layperson callers can effectively stop simulated bleeding using an improvised or a commercial tourniquet, when provided with scripted instructions via phone from a trained protocol-aided EMD. Methods : This was a prospective, randomized trial involving layperson volunteers, done at four locations in Salt Lake City, Utah, USA. Volunteers were assigned randomly to three groups: one for each of two commonly available commercial tourniquets and one for an improvised tourniquet. Results : A total of 246 subjects participated in the study at the four locations between February 11, 2019 and June 22, 2019. The overall median time for all trials (i.e., elapsed time from the start to the end of the simulation) was 3 minutes and 19 seconds. Median time to stop the bleeding (i.e., elapsed time from the start of the simulation to the time the participant was able to successfully stop the bleeding) was 2 minutes and 57 seconds. Median tourniquet pressure was 256 mmHg and median-end blood loss was 1,365 mL. A total of 198 participants (80.49%) were able to  completely  stop the bleeding while 16 participants (6.5%) had the tourniquet applied with some bleeding still occurring, and 32 participants (13.01%) exceeded the threshold of 2,500 mL of blood loss, resulting in the ""patient"" not surviving. Conclusions : The study findings demonstrated that untrained bystanders provided with instructions via phone from a trained Emergency Medical Dispatcher applied a tourniquet and successfully stopped the bleeding completely in most cases.",2020,The study findings demonstrated that untrained bystanders provided with instructions via phone from a trained Emergency Medical Dispatcher applied a tourniquet and successfully stopped the bleeding completely in most cases.,"['246 subjects participated in the study at the four locations between February 11, 2019 and June 22, 2019', 'layperson volunteers, done at four locations in Salt Lake City, Utah, USA', 'Iraq and Afghanistan', 'A total of 198 participants (80.49%) were able to  completely  stop the bleeding while 16 participants (6.5%) had the tourniquet applied with some bleeding still occurring, and 32 participants (13.01%) exceeded the threshold of 2,500\u2009mL of blood loss, resulting in the ""patient"" not surviving']","['Telephone instructions by trained emergency medical dispatchers (EMDs', 'commercial tourniquets and one for an improvised tourniquet']","['Median tourniquet pressure', 'Median time to stop the bleeding', 'overall median time']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C4277717', 'cui_str': 'Emergency Medical Dispatcher'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",246.0,0.0398299,The study findings demonstrated that untrained bystanders provided with instructions via phone from a trained Emergency Medical Dispatcher applied a tourniquet and successfully stopped the bleeding completely in most cases.,"[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Olola', 'Affiliation': ''}, {'ForeName': 'Marie Isabel', 'Initials': 'MI', 'LastName': 'Gardett', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ashwood', 'Affiliation': ''}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Broadbent', 'Affiliation': ''}, {'ForeName': 'Srilakshmi', 'Initials': 'S', 'LastName': 'Sangaraju', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stiegler', 'Affiliation': ''}, {'ForeName': 'Mark Conrad', 'Initials': 'MC', 'LastName': 'Fivaz', 'Affiliation': ''}, {'ForeName': 'Jeff J', 'Initials': 'JJ', 'LastName': 'Clawson', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1718259']
504,31661578,Effects of genotype on TENS effectiveness in controlling knee pain in persons with mild to moderate osteoarthritis.,"BACKGROUND


This study examined the extent to which genetic variability modifies Transcutaneous Electrical Nerve Stimulation (TENS) effectiveness in osteoarthritic knee pain.
METHODS


Seventy-five participants with knee osteoarthritis were randomly assigned to either: (a) High-frequency TENS, (b) Low-frequency TENS or (c) Transient Placebo TENS. Pain measures were collected pre- and post-treatment. Participants were genotyped on genes implicated in central or peripheral pain pathways: NGFB, NTRK1, EDNRA, EDNRB, EDN1, OPRM1, TAC1, TACR1, BDNF, BDKRB1, 5HTT, COMT, ESR2, IL6 and IL1B. Genetic association using linear regression modelling was performed separately for the transient placebo TENS subjects, and within the High-frequency TENS + Low-frequency TENS participants, including TENS level as a covariate.
RESULTS


In the placebo group, SNPs rs165599 (COMT) was significantly associated with an increased heat pain threshold (β = -1.87; p = .003) and rs6827096 (EDNRA) with an increased resting pain (β = 2.68; p = .001). Within the treatment groups, TENS effectiveness was reduced by the SNP rs6537485 (EDNRA) minor allele in relationship to mechanical sensation (β = 184.13; p = 5.5E-9). Individuals with the COMT rs4680 minor allele reported lowered pain at rest after TENS (β = -42.30; p = .001), with a higher magnitude of pain reduction (28 unit difference) in the low-frequency TENS group compared to the high-frequency TENS group (β = 28.37; p = .0004).
CONCLUSIONS


EDNRA and COMT are implicated in osteoarthritic knee pain and provide a basis for tailoring TENS interventions according to individual characteristics.
SIGNIFICANCE


Findings from this study demonstrate that genetic variation within the COMT and EDNRA genes influences the effectiveness of TENS, a non-pharmacologic pain-reduction intervention, in the context of osteoarthritic knee pain. Evidence such as this may contribute to risk models that provide a clinically useful tool for personalizing TENS interventions according to individual characteristics in order to best control pain and maximize functional status.",2020,"In the placebo group, SNPs rs165599 (COMT) was significantly associated with an increased heat pain threshold (β = -1.87; p = .003) and rs6827096 (EDNRA) with an increased resting pain (β = 2.68; p = .001).","['Seventy-five participants with knee osteoarthritis', 'persons with mild to moderate osteoarthritis', 'osteoarthritic knee pain']","['placebo', 'Transcutaneous Electrical Nerve Stimulation (TENS', 'High Frequency TENS, 2) Low Frequency TENS, or 3) Transient Placebo TENS']","['TENS effectiveness', 'lowered pain', 'osteoarthritic knee pain', 'resting pain', 'Pain measures', 'pain reduction', 'heat pain threshold', 'SNPs rs165599 (COMT']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]",75.0,0.0531762,"In the placebo group, SNPs rs165599 (COMT) was significantly associated with an increased heat pain threshold (β = -1.87; p = .003) and rs6827096 (EDNRA) with an increased resting pain (β = 2.68; p = .001).","[{'ForeName': 'Manika', 'Initials': 'M', 'LastName': 'Govil', 'Affiliation': 'Department of Oral Biology, Center for Craniofacial and Dental Genetics, School of Dental Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Oral Biology, Center for Craniofacial and Dental Genetics, School of Dental Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Holwerda', 'Affiliation': 'Mary Free Bed Rehabilitation Spine Center, Grand Rapids, MI, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sluka', 'Affiliation': 'Graduate Program in Physical Therapy and Rehabilitation, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rakel', 'Affiliation': 'The University of Iowa College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Schutte', 'Affiliation': 'Wayne State University College of Nursing, Detroit, MI, USA.'}]","European journal of pain (London, England)",['10.1002/ejp.1497']
505,31924234,"A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas).","BACKGROUND


Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider's histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney and pancreas preservation. Organ preservation with both solutions is comparable; recently, however, Custodiol® solution has been modified to Custodiol-N according to the needs of today. Thus, our study was defined to study its effect in clinical transplantation.
METHODS


Patients undergoing kidney transplantation (n = 412) (including approximately 30 combined kidney-pancreas) or liver transplantation (n = 202) receive grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation.
DISCUSSION


Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution. Further clinical safety data on Custodiol-N for cardioplegia are available. Thus, this study was designed to compare Custodiol® with Custodiol-N for the first time in a prospective, randomized, single-blinded, multicentre, phase III clinical transplantation trial.
TRIAL REGISTRATION


Eudra-CT, 2017-002198-20. Registered on 28 November 2018.",2020,"DISCUSSION


Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution.","['organ transplantation (kidney, liver and pancreas', 'Patients undergoing kidney transplantation (n\xa0=\u2009412) (including approximately 30 combined kidney-pancreas) or liver transplantation (n\xa0=\u2009202) receive']","['grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation', 'Custodiol® solution', ""Wisconsin and Bretschneider's histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution"", 'Custodiol-N solution']",[],"[{'cui': 'C0029216', 'cui_str': 'Grafting, Organ'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C2933836', 'cui_str': 'Custodiol-N solution'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}]",[],,0.0682638,"DISCUSSION


Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Kniepeiss', 'Affiliation': 'General, Visceral and Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Houben', 'Affiliation': 'Department of General, Visceral and Transplant Surgery, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Stiegler', 'Affiliation': 'General, Visceral and Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Berghold', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Riedl', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kahn', 'Affiliation': 'General, Visceral and Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schemmer', 'Affiliation': 'General, Visceral and Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria. Peter.schemmer@medunigraz.at.'}]",Trials,['10.1186/s13063-019-3823-4']
506,31924255,Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.,"BACKGROUND


Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown. We describe the theoretical basis and the rationale for a study protocol of a feasibility randomised controlled trial (RCT) comparing two attention trainings (ABMT vs Mindfulness Training [MT]) in people with overweight or obesity. The aim of this study is to inform the development of a large-scale RCT in relation to acceptability and attendance rates and to identify preliminary evidence for the interventions' clinical efficacy and potential underlying mechanisms.
DESIGN


Forty-five adults who are either overweight or obese (minimum body mass index of 25 kg/m 2 ) will be randomly allocated to receive eight sessions over eight weeks of either computerised ABMT or MT or be on a waiting list. Clinical and cognitive outcomes will be assessed at baseline, post-treatment (8 weeks) and follow-up (12 weeks post-randomisation). These include mood, body composition and attention biases. Credibility and acceptability of the trainings will be assessed using questionnaires, and recruitment and retention rates will be recorded.
DISCUSSION


Findings will inform the feasibility of developing a large-scale RCT that takes into consideration effect sizes for primary outcome measures and the acceptability of the design. The study will also provide preliminary evidence on the clinical efficacy of two different attention trainings for people with obesity and associated underlying mechanisms.
TRIAL REGISTRATION


ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018.",2020,"Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown.","['people with overweight or obesity', 'Forty-five adults who are either overweight or obese', 'people with obesity (e.g. attention bias to food cues', 'people with obesity and associated underlying mechanisms', 'adults with overweight or obesity']","['attention trainings (ABMT vs Mindfulness Training [MT', 'computerised ABMT or MT', 'Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions', 'food-related computerised attention training versus mindfulness training and waiting-list control']",['Credibility and acceptability'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}]","[{'cui': 'C0556509', 'cui_str': 'Attention training (regime/therapy)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",45.0,0.0908558,"Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Mercado', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Werthmann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Albert-Ludwigs University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Campbell', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. ulrike.schmidt@kcl.ac.uk.""}]",Trials,['10.1186/s13063-019-3932-0']
507,31924256,Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial.,"BACKGROUND


The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation have shown that fascial-point needling can effectively alleviate hand spasm immediately after stroke, but further evidence from large-sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial-point acupuncture on hand spasm after stroke.
METHODS/DESIGN


This multicenter randomized controlled trial will compare the efficacy of fascial-point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial-point acupuncture, the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indices are the remission of hand spasm and the duration of spasm remission. The second evaluation indices are the hand function of the affected limbs and the activities of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage.
DISCUSSION


Our aim is to evaluate the efficacy of fascial-point acupuncture in relieving hand spasm after stroke. The results should provide more evidence for the clinical application of this therapy in the future.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR), ID: ChiCTR1900022379. Registered on 9 April 2019.",2020,"BACKGROUND


The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands.","['stroke patients with hand spasm', '210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4\u2009weeks of intervention']","['Acupuncture of fascia points', 'fascial-point acupuncture', 'fascial-point acupuncture, the sham acupuncture or the control (routine rehabilitation therapy', 'fascial-point acupuncture versus sham acupuncture and routine rehabilitation therapy']",['remission of hand spasm and the duration of spasm remission'],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.110029,"BACKGROUND


The loss of functional ability of patients after stroke is mostly caused by dysfunction of the upper limbs, especially the hands.","[{'ForeName': 'Zeng-Qiao', 'Initials': 'ZQ', 'LastName': 'Zhang', 'Affiliation': ""Department of orthopedic rehabilitation, the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 358 Datong Road, Shanghai, 200137, China.""}, {'ForeName': 'Kun-Peng', 'Initials': 'KP', 'LastName': 'Li', 'Affiliation': 'Department of Neurological Rehabilitation, the Second Rehabilitation Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Jiang', 'Affiliation': ""Department of orthopedic rehabilitation, the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 358 Datong Road, Shanghai, 200137, China.""}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurological Rehabilitation, the Second Rehabilitation Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Xiao-Shen', 'Initials': 'XS', 'LastName': 'Hu', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""Department of orthopedic rehabilitation, the Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 358 Datong Road, Shanghai, 200137, China. fengweitg@yeah.net.""}]",Trials,['10.1186/s13063-019-3999-7']
508,31915064,Personalising psychotherapies for depression using a novel mixed methods approach: an example from Morita therapy.,"BACKGROUND


Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years. Novel alternative methods to generate hypotheses for prospective testing are therefore required, and we showcase mixed methods as one such approach. By exploring patients' perspectives in depth, and integrating qualitative and quantitative data at the level of the individual, we may identify new potential psychosocial predictors of psychotherapy outcomes, potentially informing the personalisation of depression treatment in a shorter timeframe. Using Morita therapy (a Japanese psychotherapy) as an exemplar, we thus explored how Morita therapy recipients' views on treatment acceptability explain their adherence and response to treatment.
METHODS


The Morita trial incorporated a pilot randomised controlled trial of Morita therapy versus treatment as usual for depression, and post-treatment qualitative interviews. We recruited trial participants from general practice record searches in Devon, UK, and purposively sampled data from 16 participants for our mixed methods analysis. We developed typologies of participants' views from our qualitative themes, and integrated these with quantitative data on number of sessions attended and whether participants responded to treatment in a joint typologies and statistics display. We enriched our analysis using participant vignettes to demonstrate each typology.
RESULTS


We demonstrated that (1) participants who could identify with the principles of Morita therapy typically responded to treatment, regardless of how many sessions they attended, whilst those whose orientation towards treatment was incompatible with Morita therapy did not respond to treatment, again regardless of treatment adherence and (2) participants whose personal circumstances impeded their opportunity to engage in Morita therapy attended the fewest sessions, though still benefitted from treatment if the principles resonated with them.
CONCLUSIONS


We identified new potential relationships between ""orientation"" and outcomes, and ""opportunity"" and adherence, which could not have been identified using existing non-integrative methods. This mixed methods approach warrants replication in future trials and with other psychotherapies to generate hypotheses, based on typologies (or profiles) of patients for whom a treatment is more or less likely to be suitable, to be tested in prospective trials.
TRIAL REGISTRATION


Current Controlled Trials, ISRCTN17544090. Registered on 23 July 2015.",2020,"BACKGROUND


Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years.","['trial participants from general practice record searches in Devon, UK, and purposively sampled data from 16 participants for our mixed methods analysis']","['Morita therapy', 'Morita therapy (a Japanese psychotherapy']",[],"[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0454849', 'cui_str': 'Devonshire (geographic location)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],,0.0885003,"BACKGROUND


Current quantitative methods for personalising psychotherapies for depression are unlikely to be able to inform clinical decision-making for hundreds of years.","[{'ForeName': 'Holly Victoria Rose', 'Initials': 'HVR', 'LastName': 'Sugg', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, Devon, UK. H.V.R.Sugg@exeter.ac.uk.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, Devon, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, Devon, UK.'}]",Trials,['10.1186/s13063-019-3788-3']
509,31915052,Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial-the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study.,"BACKGROUND


Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity, and mortality.
METHODS/DESIGN


A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 h of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan, and two-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax, and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission, and healthcare costs.
DISCUSSION


This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants commenced in September 2018 and is estimated to be completed by March 2020.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trial Registry, ACTRN12618001442291. Registered on 28 August 2018.",2020,"BACKGROUND


Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management.","['250 patients will be recruited at one tertiary hospital', 'patients admitted to internal medicine wards attractive', 'internal medicine inpatients with cardiopulmonary diagnosis at admission', 'internal medicine physician during the first 24\u2009h of patient admission to the unit with a presumptive cardiopulmonary diagnosis', 'internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay']","['POCUS or no POCUS', 'care ultrasound (POCUS', 'point-of-care ultrasound', 'IMFCU-1']","['length of stay, morbidity, and mortality', 'hospital length of stay', 'change in diagnosis and management, 30-day hospital readmission, and healthcare costs']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030673', 'cui_str': 'Patient Admission'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",250.0,0.0734478,"BACKGROUND


Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management.","[{'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Cid', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, VIC, Australia. anaite.cid@gmail.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canty', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Maier', 'Affiliation': 'Department of Medicine and Community Care, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine and Community Care, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Doa', 'Initials': 'D', 'LastName': 'El-Ansary', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Clarke-Errey', 'Affiliation': 'Statistical Consulting Centre, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fazio', 'Affiliation': 'Business Intelligence Unit, Melbourne Health, Parkville, VIC, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Melbourne, VIC, Australia.'}]",Trials,['10.1186/s13063-019-4003-2']
510,31915058,"Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study.","BACKGROUND


Cerebrovascular reactivity (CVR) is the change in cerebral blood flow in response to a vaso-active stimulus, and may assist the treatment strategy of ischemic stroke. However, previous studies reported that a therapeutic strategy for stroke mainly depends on the degree of vascular stenosis with steady-state vascular parameters (e.g., cerebral blood flow and CVR). Hence, measurement of CVR by multimodal imaging techniques may improve the treatment of ischemic stroke.
METHODS/DESIGN


This is a prospective, randomized, controlled clinical trial that aimed to examine the capability of multimodal imaging techniques for the evaluation of CVR to improve treatment of patients with ischemic stroke. A total of 66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine. The patients will be categorized based on CVR into two subgroups as follows: CVR > 10% group and CVR < 10% group. The patients will be randomly assigned to medical management, percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass groups in a 1:1:1 ratio. The primary endpoint is all adverse events and ipsilateral stroke recurrence at 6, 12, and 24 months after management. The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months.
DISCUSSION


Measurement of cerebrovascular reserve by multimodal image is recommended by most recent studies to guide the treatment of ischemic stroke, and thus its efficacy and evaluation accuracy need to be established in randomized controlled settings. This prospective, parallel, randomized, controlled registry study, together with other ongoing studies, should present more evidence for optimal individualized accurate treatment of ischemic stroke.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009635; Registered on 16 October 2016. All items are from the World Health Organization Trial Registration Data Set and registration in the Chinese Clinical Trial Registry: ChiCTR-IOR-16009635.",2020,"The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months.
","['66 eligible patients will be recruited from Renji Hospital, Shanghai Jiaotong University School of Medicine', 'cerebral arterial occlusion or stenosis patients', 'patients with ischemic stroke']","['multimodal imaging', 'percutaneous transluminal angioplasty and stenting, and intracranial and extra-cranial bypass']","['adverse events and ipsilateral stroke recurrence', 'CVR, the National Institute of Health stroke scale and the Modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0028790', 'cui_str': 'Cerebral arterial occlusion'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C1513743', 'cui_str': 'Multimodal Imaging'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",66.0,0.0678847,"The secondary outcomes include the CVR, the National Institute of Health stroke scale and the Modified Rankin Scale at 6, 12, and 24 months.
","[{'ForeName': 'Zhi-Peng', 'Initials': 'ZP', 'LastName': 'Xiao', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China.""}, {'ForeName': 'Jie-Qing', 'Initials': 'JQ', 'LastName': 'Wan', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China.""}, {'ForeName': 'Yao-Hua', 'Initials': 'YH', 'LastName': 'Pan', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China.""}, {'ForeName': 'Yi-Chao', 'Initials': 'YC', 'LastName': 'Jin', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China.""}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Renji Hospital, School of Medicine of Shanghai JiaoTong University, Shanghai, 200127, People's Republic of China. zxh1969@aliyun.com.""}]",Trials,['10.1186/s13063-019-3967-2']
511,31915072,Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial.,"BACKGROUND


Sepsis is a health problem of global importance; treatments focus on controlling infection and supporting failing organs. Recent clinical research suggests that intravenous vitamin C may decrease mortality in sepsis. We have designed a randomized controlled trial (RCT) to ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days in patients with sepsis.
METHODS


LOVIT (Lessening Organ dysfunction with VITamin C) is a multicenter, parallel-group, blinded (participants, clinicians, study personnel, Steering Committee members, data analysts), superiority RCT (minimum n = 800). Eligible patients have sepsis as the diagnosis for admission to the intensive care unit (ICU) and are receiving vasopressors. Those admitted to the ICU for more than 24 h are excluded. Eligible patients are randomized to high-dose intravenous vitamin C (50 mg/kg every 6 h for 96 h) or placebo. The primary outcome is a composite of death or persistent organ dysfunction (need for vasopressors, invasive mechanical ventilation, or new and persisting renal replacement therapy) at day 28. Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia). Six subgroup analyses are planned.
DISCUSSION


This RCT will provide evidence of the effect of high-dose intravenous vitamin C on patient-important outcomes in patients with sepsis.
TRIAL REGISTRATION


clinicaltrials.gov, NCT03680274, first posted 21 September 2018.",2020,"Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia).","['patients with sepsis', 'Eligible patients', 'Eligible patients have sepsis as the diagnosis for admission to the intensive care unit (ICU) and are receiving vasopressors']","['vitamin C', 'superiority RCT ', 'placebo', 'intravenous vitamin C', 'VITamin C (LOVIT', 'VITamin C']","['persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6\u2009months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia', 'composite of death or persistent organ dysfunction (need for vasopressors, invasive mechanical ventilation, or new and persisting renal replacement therapy', 'death or persistent organ dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}]",800.0,0.613394,"Secondary outcomes include persistent organ dysfunction-free days to day 28, mortality and health-related quality of life at 6 months, biomarkers of dysoxia, inflammation, infection, endothelial function, and adverse effects (hemolysis, acute kidney injury, and hypoglycemia).","[{'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Masse', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ménard', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Battista', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke Sherbrooke and Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gordon H', 'Initials': 'GH', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Kanji', 'Affiliation': 'Departments of Pharmacy and Critical Care, The Ottawa Hospital and Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Day', 'Affiliation': 'Kingston General Health Research Institute, Kingston, ON, Canada.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'No institutional affiliation, No institutional affiliation, Sherbrooke, QC, Canada.'}, {'ForeName': 'Djillali', 'Initials': 'D', 'LastName': 'Annane', 'Affiliation': 'General Intensive Care Unit, Raymond Poincaré Hospital (AP-HP), Lab Inflammation & Infection, U1173 University Paris Saclay-UVSQ/INSERM, Garches, France.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular ICU, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular ICU, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Anitra', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Bharath Kumar Tirupakuzhi', 'Initials': 'BKT', 'LastName': 'Vijayaraghavan', 'Affiliation': 'Department of Critical Care Medicine, Apollo Hospitals, Chennai, India.'}, {'ForeName': 'Frédérick', 'Initials': 'F', 'LastName': ""D'Aragon"", 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke Sherbrooke and Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Élaine', 'Initials': 'É', 'LastName': 'Carbonneau', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maslove', 'Affiliation': ""Department of Critical Care Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hunt', 'Affiliation': ""Department of Critical Care Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, ON, Canada.""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': 'Department of Medicine and Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Millen', 'Affiliation': 'Juravinski Hospital, Hamilton, ON, Canada.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Chassé', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Lebrasseur', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Archambault', 'Affiliation': 'Faculté de Médecine, Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Estel', 'Initials': 'E', 'LastName': 'Deblois', 'Affiliation': 'Département des soins intensifs du Centre intégré de santé et des services sociaux de Chaudière-Appalaches (Secteur Alphonse-Desjardins), Lévis, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Drouin', 'Affiliation': ""Department of Critical Care Research, St. Joseph's Healthcare, Hamilton, ON, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lellouche', 'Affiliation': ""Department of Medecine, Université Laval and Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec, Québec City, QC, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lizotte', 'Affiliation': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec City, QC, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Watpool', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Porteous', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Clarke', 'Affiliation': ""Department of Critical Care Research, St. Joseph's Healthcare, Hamilton, ON, Canada.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marinoff', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Émilie', 'Initials': 'É', 'LastName': 'Belley-Côté', 'Affiliation': 'Division of Cardiology, Department of Medicine, McMaster University, Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Bolduc', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Canada and Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Iazzetta', 'Affiliation': 'Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada. neill.adhikari@utoronto.ca.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke Sherbrooke and Université de Sherbrooke, Sherbrooke, QC, Canada. francois.lamontagne@usherbrooke.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3834-1']
512,31910885,How to collect non-medical data in a pediatric trial: diaries or interviews.,"BACKGROUND


Non-medical data, such as the amount of time that patients and caregivers spend managing their condition, may be relevant when assessing therapeutic strategies. For chronic pediatric conditions, the time that patients and caregivers spend in seeking and providing care (which are the indirect costs in an economic evaluation) can be significantly different depending on the treatment arm. To explore methods for collecting information on the care burden for caregivers and patients, we investigated whether a patient diary provided additional information compared to retrospective investigator-led interviews and whether a diary that was completed intermittently produced more or less information than a diary completed continually. The main objective of this study was to identify which type of data collection was most effective for measuring the time spent by caregivers and for estimating indirect treatment costs over 9 months.
METHODS


Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring for 12 months in children and adolescents with type 1 diabetes. We designed an ancillary study to assess methods of collecting information on the time spent by patients and caregivers in managing their condition (indirect costs). Data were entered retrospectively in case report forms (CRFs) by investigators during quarterly follow-up visits, which were supplemented with diaries completed prospectively by children or caregivers either continuously or intermittently. Data about absences from school and work as well as the time that caregivers spent on diabetes care were collected and the three collection methods were compared.
RESULTS


At the end of the 9-month study, 42% of the study participants failed to return their diary. For the diaries that were received, less than 10% of expected data were collected versus 82% during investigators'interviews. Based on all the information collected, we calculated that over 9 months, caregivers lost on average 3.9 days of working time (€786) and 4 days of personal time, i.e. the equivalent of €526, and spent around 15 min of time on care per day, i.e. the equivalent of €1700.
CONCLUSIONS


The CRFs completed by investigators during quarterly visits cannot be replaced by a diary. Completing the diaries appeared to represent an important additional burden to children and their caregivers, and the diaries provided little additional information compared to investigators' entries in the CRF.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT00949221. Registered on 30 July 2009. Registry name: Study of Insulin Therapy Augmented by Real Time Sensor in Type 1 Children and Adolescents (START-IN!).",2020,Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring for 12 months in children and adolescents with type 1 diabetes.,"['Type 1 Children and Adolescents (START-IN', 'caregivers and patients', 'patients and caregivers in managing their condition (indirect costs', '12\u2009months in children and adolescents with type 1 diabetes']","['Insulin Therapy Augmented by Real Time Sensor', 'real-time continuous glucose monitoring']",[],"[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]",[],,0.104731,Start-In! is a randomized controlled trial comparing the efficacy of three strategies of real-time continuous glucose monitoring for 12 months in children and adolescents with type 1 diabetes.,"[{'ForeName': 'Anaïs', 'Initials': 'A', 'LastName': 'Le Jeannic', 'Affiliation': 'AP-HP, Groupe hospitalier Hôtel-Dieu, URC Economie de la Santé Ile de France, Paris, France. anais.lejeannic@urc-eco.fr.'}, {'ForeName': 'Hassani', 'Initials': 'H', 'LastName': 'Maoulida', 'Affiliation': 'AP-HP, Groupe hospitalier Hôtel-Dieu, URC Economie de la Santé Ile de France, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guilmin-Crépon', 'Affiliation': 'Inserm, ECEVE UMR-S 1123, Paris, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alberti', 'Affiliation': 'Inserm, ECEVE UMR-S 1123, Paris, France.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tubiana-Rufi', 'Affiliation': 'Université Paris Diderot, PRES Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': 'AP-HP, Groupe hospitalier Hôtel-Dieu, URC Economie de la Santé Ile de France, Paris, France.'}]",Trials,['10.1186/s13063-019-3997-9']
513,31910891,The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial.,"BACKGROUND


Current evidence suggests that some of the most effective weight loss approaches are changes in dietary and physical activity behaviors through lifestyle modification programs. The Group Lifestyle Balance (GLB) program is a group-based behavior modification program aimed at changing diet and physical activity for weight loss. It was developed to be more cost-effective and easier to disseminate than its individually administered parent program, the Diabetes Prevention Program (DPP). However, the average weight loss following participation in the GLB is only approximately 3.5%, with low long-term weight loss maintenance.
PURPOSE


We aimed to optimize the weight loss outcomes of the GLB to increase the efficacy already afforded by its cost-effectiveness and ease of dissemination. We did this by integrating the habit formation tool of if-then plans into the program. This program is called the enriched GLB or the McGill Comprehensive Health Improvement (CHIP) Healthy Weight Program. Results at 3 and 12 months of participation have already been published elsewhere. They showed no between-group differences between the standard and enriched GLB but higher weight loss in both groups compared to the DPP. This paper reports the long-term weight loss maintenance data following participation in the program.
METHODS


Of the 172 participants enrolled at the beginning of the study, data from 110 participants were available and analyzed at 24 months, i.e., 12 months after the end of the 12-month intervention.
RESULTS


No between-group difference in weight loss maintenance was observed. Pooled results showed a significant weight regain from 12 to 24 months, i.e., an average of 7.85 lbs. of the 20.36 lbs. lost. However, participants from both groups were still 12.51lbs or 6.13% lighter at 24 months than at baseline.
CONCLUSION


If-then plans did not result in a higher percentage of weight loss at 24-month follow-up compared to the standard GLB. However, at 24 months, both groups did show a maintenance of a significant portion of the weight lost at the end of intervention.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02008435, registered 6 December 2013.",2020,If-then plans did not result in a higher percentage of weight loss at 24-month follow-up compared to the standard GLB.,"['Of the 172 participants enrolled at the beginning of the study, data from 110 participants were available and analyzed at 24\u2009months, i.e., 12\u2009months after the end of the 12-month intervention']",[],"['weight loss', 'McGill Comprehensive Health Improvement (CHIP', 'weight regain', 'weight lost', 'average weight loss', 'weight loss maintenance']","[{'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",110.0,0.0264829,If-then plans did not result in a higher percentage of weight loss at 24-month follow-up compared to the standard GLB.,"[{'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Knäuper', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. barbel.knauper@mcgill.ca.'}, {'ForeName': 'Huma', 'Initials': 'H', 'LastName': 'Shireen', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Carrière', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Frayn', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ivanova', 'Affiliation': 'University of British Columbia, Okanagan Campus, Kelowna, BC, Canada.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Lowensteyn', 'Affiliation': 'Department of Medicine and Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Gentiana', 'Initials': 'G', 'LastName': 'Sadikaj', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Luszczynska', 'Affiliation': 'SWPS University of Social Sciences and Humanities, Wroclaw Faculty of Psychology, Wroclaw, Poland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Grover', 'Affiliation': 'Department of Medicine and Epidemiology and Biostatistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-4014-z']
514,31910896,Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial.,"BACKGROUND


Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient's quality of life and can be associated with conditions such as fatigue, headache, cognitive impairment, and sleep disturbances. Various complementary and alternative medicine treatments have been used for this condition in clinical practice. The Ayurveda system of medicine is the most common complementary medicine system practiced in Sri Lanka. The aim of this study is to examine the efficacy and safety of a decoction used in traditional Ayurveda for allergic rhinitis and its ready- to-use freeze dried formulation in comparison to an antihistamine over a period of 4 weeks on relief of symptoms in allergic rhinitis.
STUDY DESIGN


This is a three-arm, open-label, non-inferiority, randomized controlled clinical trial enrolling patients with AR. Tamalakyadi decoction containing 12 ingredients (TMD12), used in traditional Ayurveda and its freeze-dried formulation are the test products. The efficacy and safety of the two Ayurvedic dosage forms will be tested against the antihistamine loratadine. Patients with symptoms of AR will be allocated randomly into the three arms after a 1-week run-in period and the medications will be given orally for 28 days. Total Nasal symptom Score (TNSS) of the patients will be used as the primary efficacy endpoint. TNSS will be recorded and compared between the three arms prior to visit 1, at the end of 28 days, and end of the first and second months of follow-up. Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points.
DISCUSSION


This clinical trial will be able to provide evidence-based scientific data on Ayurvedic dosage form, TMD12, and the freeze-dried formulation in the treatment of allergic rhinitis. This trial is expected to develop capacity to scientifically evaluate various Ayurvedic treatments that are claimed to have efficacy in treatment of various disease conditions.
TRIAL REGISTRATION


ISRCTN18149439 (6 May 2019).",2020,"Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points.
","['patients with AR', 'Patients with symptoms of AR', 'allergic rhinitis', 'Allergic rhinitis (AR']","['antihistamine loratadine', 'decoction', 'antihistamine', 'Tamalakyadi decoction containing 12 ingredients (TMD12', 'TNSS']","['efficacy and safety', 'fatigue, headache, cognitive impairment, and sleep disturbances', 'Efficacy and safety', 'Total Nasal symptom Score (TNSS', 'Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}]","[{'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0065180', 'cui_str': 'Loratadine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0379509,"Symptom scores of daytime nasal symptoms, night time nasal symptoms, non-nasal symptoms and health-related quality of life questionnaire are used as secondary end points.
","[{'ForeName': 'Jeevani Maheshika', 'Initials': 'JM', 'LastName': 'Dahanayake', 'Affiliation': 'Dravyaguna Vignanana Unit (Ayurveda Pharmacology and Pharmaceutics), Department of Ayurveda, Institute of Indigenous Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Pathirage Kamal', 'Initials': 'PK', 'LastName': 'Perera', 'Affiliation': 'Dravyaguna Vignanana Unit (Ayurveda Pharmacology and Pharmaceutics), Department of Ayurveda, Institute of Indigenous Medicine, University of Colombo, Colombo, Sri Lanka. drkamalperera@yahoo.com.'}, {'ForeName': 'Priyadarshani', 'Initials': 'P', 'LastName': 'Galappaththy', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Dulani', 'Initials': 'D', 'LastName': 'Samaranayake', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}]",Trials,['10.1186/s13063-019-4004-1']
515,31941527,Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial.,"BACKGROUND


Colorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, the effect of mailed FIT kits may differ across important subpopulations. The goal of the current study was to examine sociodemographic and health-related factors that moderate the effect of an intervention of automated direct mail of FIT kits at health clinics serving low-income populations.
METHODS


This study is a secondary analysis of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study, a cluster-randomized pragmatic trial to increase uptake of CRC screening in patients seen at federally qualified health centers. The intervention involved tools embedded in the electronic medical records to enable participating clinics to mail FIT kits and related materials to eligible participants. We examined the rate of FIT completion by potential moderating characteristics using electronic health record data supplemented by the American Community Survey and the Centers for Medicare & Medicaid Services Geographic Variation datasets, linked via geocoding to patients' addresses. All patients aged 50-75 seen in participating health clinics who were eligible for CRC screening were included.
RESULTS


Although not always statistically significant, we saw a consistent pattern of increased FIT return rates among intervention participants compared to control participants across all subgroups studied, with incidence rate ratios (IRRs) generally ranging from 1.25 to 1.50. FIT completion in the intervention group ranged from 15 and 20% across subpopulations, typically three to six percentage points higher than the control group participants. The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00).
CONCLUSIONS


Response to a mailed FIT intervention was generally consistent across a wide range of individual and neighborhood-level patient characteristics, including typically underserved patients and those in low-resource communities.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01742065. Registered on 5 December 2012.",2020,"The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00).
","['All patients aged 50-75 seen in participating health clinics who were eligible for CRC screening were included', 'patients seen at federally qualified health centers']",[],"['colorectal cancer screening', 'FIT completion', 'FIT return rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]",[],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",75.0,0.118581,"The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00).
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': ""O'Connor"", 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Elizabeth.OConnor@kpchr.org.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Vollmer', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Suite, Seattle, WA, 1600, USA.'}, {'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}]",Trials,['10.1186/s13063-019-4027-7']
516,31941544,"Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial.","BACKGROUND


Tumour necrosis factor inhibitors (TNFi) are effective in the treatment of patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). However, these drugs come with some disadvantages such as adverse events, practical burden for patients and high costs. Dose optimisation of TNFi after patients have reached low disease activity (LDA) has been shown feasible and safe in rheumatoid arthritis (RA). However, data on TNFi dose optimisation in PsA and axSpA are scarce, especially pragmatic, randomised strategy studies.
METHODS


We developed an investigator-driven, pragmatic, open-label, randomised, controlled, non-inferiority trial (DRESS-PS) to compare the effects of a disease activity-guided treat-to-target strategy with or without a tapering attempt in patients with SpA (PsA and axSpA combined), ≥ 16 years of age, who are being treated with TNFi, and have had at least 6 months of low disease activity. The primary outcome is the percentage of patients in LDA after 12 months of follow up. Patients are assessed at baseline, 3, 6, 9, and 12 months of follow up. Bayesian power analyses with a weakened prior based on a similar study performed in RA resulted in a sample size of 95 patients in total.
DISCUSSION


More knowledge on disease activity-guided treatment algorithms would contribute to better treatment choices and cost savings and potentially decrease the risk of side effects. In this article we elucidate some of our design choices on TNFi dose optimisation and its clinical and methodological consequences.
TRIAL REGISTRATION


Dutch Trial Register, NL6771. Registered on 27 November 2018 (CMO NL66181.091.18, 23 October 2018).",2020,Dose optimisation of TNFi after patients have reached low disease activity (LDA) has been shown feasible and safe in rheumatoid arthritis (RA).,"['patients with spondyloarthritis (SpA), including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA', 'psoriatic arthritis and axial spondyloarthritis', '95 patients in total', 'patients with SpA (PsA and axSpA combined), ≥\u200916\u2009years of age, who are being treated with TNFi, and have had at least 6 months of low disease activity']","['TNFi', 'TNF-inhibitors', 'Tumour necrosis factor inhibitors (TNFi', 'disease activity-guided treat-to-target strategy with or without a tapering attempt']",['percentage of patients in LDA'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",95.0,0.178282,Dose optimisation of TNFi after patients have reached low disease activity (LDA) has been shown feasible and safe in rheumatoid arthritis (RA).,"[{'ForeName': 'Celia A J', 'Initials': 'CAJ', 'LastName': 'Michielsens', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands. c.michielsens@maartenskliniek.nl.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Boers', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'den Broeder', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wenink', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Aatke', 'Initials': 'A', 'LastName': 'van der Maas', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Elien A M', 'Initials': 'EAM', 'LastName': 'Mahler', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Michelle L M', 'Initials': 'MLM', 'LastName': 'Mulder', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Frank H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Verhoef', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}, {'ForeName': 'Alfons A', 'Initials': 'AA', 'LastName': 'den Broeder', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, 6574 NA, Nijmegen, The Netherlands.'}]",Trials,['10.1186/s13063-019-4000-5']
517,31941546,A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards.,"BACKGROUND


The optimal treatment duration for patients with bloodstream infection is understudied. The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. We performed this BALANCE-Ward pilot RCT to examine the feasibility and impact of potentially extending the BALANCE main RCT to include patients hospitalized on non-ICU wards.
METHODS


We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. The co-primary feasibility outcomes were recruitment rate and adherence to treatment duration protocol. We compared feasibility outcomes, patient/pathogen characteristics, and overall outcomes among those enrolled in this BALANCE-Ward and prior BALANCE-ICU pilot RCTs. We estimated the sample size and non-inferiority margin impacts of expanding the BALANCE main RCT to include non-ICU patients.
RESULTS


A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1-4.4 patients/site-month). The overall recruitment rate exceeded the BALANCE-ICU pilot RCT (mean 1.10 patients/site-month, p < 0.0001). Overall protocol adherence also exceeded the adherence in the BALANCE-ICU pilot RCT (125/134, 93% vs 89/115, 77%, p = 0.0003). BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection. The BALANCE-Ward pilot RCT patients had an overall 90-day mortality rate of 17/133 (12.8%), which was comparable to the 90-day mortality rate in the ICU pilot RCT (17/115, 14.8%) (p = 0.65). Simulation models indicated there would be minimal sample size and non-inferiority margin implications of expanding enrolment to increasing proportions of non-ICU versus ICU patients.
CONCLUSION


It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02917551. Registered on September 28, 2016.",2020,"BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection.","['A total of 134 patients were recruited over 47 site-months (mean 2.9 patients/site-month, median 1.0, range 0.1-4.4 patients/site-month', 'subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14\u2009days of antibiotic treatment', 'patients hospitalized on non-ICU wards', 'patients with bloodstream infection', 'bloodstream infection on non-intensive care versus intensive care wards']",['antibiotic treatment'],"['Overall protocol adherence', 'Bacteremia Antibiotic Length', '90-day mortality rate', 'overall 90-day mortality rate', 'overall recruitment rate', 'rate and adherence to treatment duration protocol']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0085559'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",134.0,0.108697,"BALANCE-Ward patients were older, with lower Sequential Organ Failure Assessment scores, and higher proportions of infections caused by Escherichia coli and genito-urinary sources of bloodstream infection.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Daneman', 'Affiliation': 'Division of Infectious Diseases & Clinical Epidemiology, Department of Medicine Sunnybrook Health Sciences Centre, University of Toronto and Adjunct Scientist, Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. nick.daneman@sunnybrook.ca.'}, {'ForeName': 'Asgar H', 'Initials': 'AH', 'LastName': 'Rishu', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, ON, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, ON, Canada.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Intensive Care Department, Ministry of National Guard Health Affairs, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Emilie P', 'Initials': 'EP', 'LastName': 'Belley-Cote', 'Affiliation': 'Division of Cardiology, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cirone', 'Affiliation': ""Division of Critical Care, St. Joseph's Health Centre, Toronto, ON, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Downing', 'Affiliation': ""Division of Infectious Diseases, St. Joseph's Health Centre, Toronto, ON, Canada.""}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Division of Critical Care Medicine, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hall', 'Affiliation': 'Departments of Critical Care Medicine and Anesthesiology, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Lauralyn', 'Initials': 'L', 'LastName': 'McIntyre', 'Affiliation': 'Division of Critical Care, Department of Medicine, The Ottawa Hospital, Ottawa, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muscedere', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'Department of Biophysiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Rogers', 'Affiliation': 'Centre for Inflammatory Diseases, Monash University School of Clinical Sciences, Clayton, Victoria, Australia; Monash Infectious Diseases, Monash Health, Clayton, VIC, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Medicine, School of Clinical Sciences, Monash University and Monash Health, Clayton, Victoria, Australia and the Clinical School of Medicine, University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Shin', 'Affiliation': 'Department of Medicine and Critical Care, North York General Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Center, Adjunct Scientist, Institute for Clinical Evaluative Sciences, Institute of Health Policy, Management and Evaluation, University of Toronto, 2075 Bayview Ave, Toronto, ON, M4N 3M5, Canada. rob.fowler@sunnybrook.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-4033-9']
518,31918739,Individualised stepwise adaptive treatment for 3-6-year-old preschool children impaired by attention-deficit/hyperactivity disorder (ESCApreschool): study protocol of an adaptive intervention study including two randomised controlled trials within the consortium ESCAlife.,"BACKGROUND


Attention-deficit/hyperactivity disorder (ADHD) is a psychosocially impairing and cost-intensive mental disorder, with first symptoms occurring in early childhood. It can usually be diagnosed reliably at preschool age. Early detection of children with ADHD symptoms and an early, age-appropriate treatment are needed in order to reduce symptoms, prevent secondary problems and enable a better school start. Despite existing ADHD treatment research and guideline recommendations for the treatment of ADHD in preschool children, there is still a need to optimise individualised treatment strategies in order to improve outcomes. Therefore, the ESCApreschool study (Evidence-Based, Stepped Care of ADHD in Preschool Children aged 3 years and 0 months to 6 years and 11 months of age (3;0 to 6;11 years) addresses the treatment of 3-6-year-old preschool children with elevated ADHD symptoms within a large multicentre trial. The study aims to investigate the efficacy of an individualised stepwise-intensifying treatment programme.
METHODS


The target sample size of ESCApreschool is 200 children (boys and girls) aged 3;0 to 6;11 years with an ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or a diagnosis of oppositional defiant disorder (ODD) plus additional substantial ADHD symptoms. The first step of the adaptive, stepped care design used in ESCApreschool consists of a telephone-assisted self-help (TASH) intervention for parents. Participants are randomised to either the TASH group or a waiting control group. The treatment in step 2 depends on the outcome of step 1: TASH responders without significant residual ADHD/ODD symptoms receive booster sessions of TASH. Partial or non-responders of step 1 are randomised again to either parent management and preschool teacher training or treatment as usual.
DISCUSSION


The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care.
TRIAL REGISTRATION


The trial was registered at the German Clinical Trials Register (DRKS) as a Current Controlled Trial under DRKS00008971 on 1 October 2015. This manuscript is based on protocol version 3 (14 October 2016).",2020,"The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care.
","['preschool children with ADHD', 'children with ADHD symptoms', '3-6-year-old preschool children impaired by attention-deficit/hyperactivity disorder (ESCApreschool', 'Preschool Children aged 3\u2009years and 0\u2009months to 6\u2009years and 11\u2009months of age (3;0 to 6;11\u2009years) addresses the treatment of 3-6-year-old preschool children with elevated ADHD symptoms within a large multicentre trial', 'preschool children with ADHD in routine clinical care', '200 children (boys and girls) aged 3;0 to 6;11\u2009years with an ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or a diagnosis of oppositional defiant disorder (ODD) plus additional substantial ADHD symptoms', 'preschool children']","['ESCApreschool consists of a telephone-assisted self-help (TASH) intervention', 'TASH', 'parent management and preschool teacher training or treatment as usual', 'Individualised stepwise adaptive treatment', 'waiting control group']",[],"[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0029121', 'cui_str': 'Oppositional Defiant Disorder'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1290973', 'cui_str': 'Telephone assisted'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],200.0,0.131967,"The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care.
","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany. katja.becker@uni-marburg.de.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Banaschewski', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brandeis', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dose', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hautmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holtmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, LWL-University Hospital Hamm, Ruhr-University Bochum, Hamm, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Jendreizik', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Jenkner', 'Affiliation': 'Clinical Trials Unit Freiburg, Medical Centre - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'John', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Ketter', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Millenet', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Pauli-Pott', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Renner', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Romanos', 'Affiliation': 'Centre of Mental Health, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Treier', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Heidelberg University, Medical Faculty Mannheim, Mannheim, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'von Wirth', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Wermter', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg, Hans-Sachs-Str. 6, 35039, Marburg, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Döpfner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Cologne, Germany.'}]",Trials,['10.1186/s13063-019-3872-8']
519,31930509,The effects of paired kinesthetic movements on literacy skills acquisition with preschoolers.,"Students who fail to acquire foundational literacy skills during preschool are more likely to read below grade level average in elementary school and are at a heightened risk for future school failure, poverty, early mortality, and crime. The purpose of this study was to compare the effects and maintenance of and preference for paired kinesthetic movements (KM) to a traditional drill (TD) procedure on letter-sound correspondence and word recognition with 6 preschool children. In 6 of 11 evaluations, participants mastered the KM set in substantially fewer intervention sessions than the TD set. In 5 of 11 evaluations, participants mastered the KM and TD sets with little differentiation between the number of intervention sessions. No participant mastered the control set. Maintenance data demonstrate a higher number of correct responses for the KM condition across all weeks. Preference varied across participants and was not always consistent with the more effective intervention.",2020,"In 5 of 11 evaluations, participants mastered the KM and TD sets with little differentiation between the number of intervention sessions.","['Students who fail to acquire foundational literacy skills during preschool', '6 preschool children', 'literacy skills acquisition with preschoolers']","['paired kinesthetic movements (KM) to a traditional drill (TD) procedure', 'paired kinesthetic movements']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0324815', 'cui_str': 'Drill'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",[],,0.0190778,"In 5 of 11 evaluations, participants mastered the KM and TD sets with little differentiation between the number of intervention sessions.","[{'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Lozy', 'Affiliation': 'Louisiana State University.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Holmes', 'Affiliation': 'Louisiana State University.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Donaldson', 'Affiliation': 'Louisiana State University.'}]",Journal of applied behavior analysis,['10.1002/jaba.677']
520,31931848,A double-blind placebo-controlled trial of azithromycin to reduce mortality and improve growth in high-risk young children with non-bloody diarrhoea in low resource settings: the Antibiotics for Children with Diarrhoea (ABCD) trial protocol.,"BACKGROUND


Acute diarrhoea is a common cause of illness and death among children in low- to middle-income settings. World Health Organization guidelines for the clinical management of acute watery diarrhoea in children focus on oral rehydration, supplemental zinc and feeding advice. Routine use of antibiotics is not recommended except when diarrhoea is bloody or cholera is suspected. Young children who are undernourished or have a dehydrating diarrhoea are more susceptible to death at 90 days after onset of diarrhoea. Given the mortality risk associated with diarrhoea in children with malnutrition or dehydrating diarrhoea, expanding the use of antibiotics for this subset of children could be an important intervention to reduce diarrhoea-associated mortality and morbidity. We designed the Antibiotics for Childhood Diarrhoea (ABCD) trial to test this intervention.
METHODS


ABCD is a double-blind, randomised trial recruiting 11,500 children aged 2-23 months presenting with acute non-bloody diarrhoea who are dehydrated and/or undernourished (i.e. have a high risk for mortality). Enrolled children in Bangladesh, India, Kenya, Malawi, Mali, Pakistan and Tanzania are randomised (1:1) to oral azithromycin 10 mg/kg or placebo once daily for 3 days and followed-up for 180 days. Primary efficacy endpoints are all-cause mortality during the 180 days post-enrolment and change in linear growth 90 days post-enrolment.
DISCUSSION


Expanding the treatment of acute watery diarrhoea in high-risk children to include an antibiotic may offer an opportunity to reduce deaths. These benefits may result from direct antimicrobial effects on pathogens or other incompletely understood mechanisms including improved nutrition, alterations in immune responsiveness or improved enteric function. The expansion of indications for antibiotic use raises concerns about the emergence of antimicrobial resistance both within treated children and the communities in which they live. ABCD will monitor antimicrobial resistance. The ABCD trial has important policy implications. If the trial shows significant benefits of azithromycin use, this may provide evidence to support reconsideration of antibiotic indications in the present World Health Organization diarrhoea management guidelines. Conversely, if there is no evidence of benefit, these results will support the current avoidance of antibiotics except in dysentery or cholera, thereby avoiding inappropriate use of antibiotics and reaffirming the current guidelines.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03130114. Registered on April 26 2017.",2020,Young children who are undernourished or have a dehydrating diarrhoea are more susceptible to death at 90 days after onset of diarrhoea.,"['high-risk young children with non-bloody diarrhoea in low resource settings', 'Children with Diarrhoea (ABCD) trial protocol', '11,500 children aged 2-23\u2009months presenting with acute non-bloody diarrhoea who are dehydrated and/or undernourished (i.e. have a high risk for mortality', 'Enrolled children in Bangladesh, India, Kenya, Malawi, Mali, Pakistan and Tanzania', 'acute watery diarrhoea in high-risk children', 'children with malnutrition or dehydrating diarrhoea', 'Young children who are undernourished or have a dehydrating diarrhoea']","['placebo', 'azithromycin', 'ABCD', 'azithromycin 10\u2009mg/kg or placebo']","['cause mortality during the 180\u2009days post-enrolment and change in linear growth 90\u2009days post-enrolment', 'mortality']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0151594', 'cui_str': 'Hemorrhagic diarrhea (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2599718', 'cui_str': 'Trial Protocols'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0239182', 'cui_str': 'Watery diarrhoea'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.453766,Young children who are undernourished or have a dehydrating diarrhoea are more susceptible to death at 90 days after onset of diarrhoea.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3829-y']
521,31915038,The PROMOTE study (High-protein and resistance-training combination in overweight and obesity) for short-term weight loss and long-term weight maintenance for Chinese people: a protocol for a pilot randomized controlled trial.,"BACKGROUND


It is very important for clinicians and dieticians to explore reasonable weight management strategies for obese people that address both short-term weight loss and subsequent weight maintenance. We hypothesized that resistance training combined with a high-protein diet would result in similar short-term weight loss but better long-term weight maintenance than either a conventional low-fat diet control or a high-protein diet alone.
METHODS/DESIGN


This is an 8-week randomized parallel controlled trial followed by a 24-week observational follow-up study. A 48-week supplementary follow-up study will be carried out if necessary. The study will be conducted between June 2019 and October 2020. The 90 overweight or obese participants will be randomly assigned to the conventional low-fat diet group, the high-protein diet group and the high-protein diet and resistance training combination group. Primary outcomes are body weight change at week 8 and week 24 compared with the baseline level.
DISCUSSION


High-quality research on the effect of a high-protein diet combined resistance training on weight loss and weight maintenance is limited in the Chinese population. Our study will provide a basis for obesity management in China and will promote the development of exercise- and diet-related studies.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900023841. Registered on 14 June 2019.",2020,"We hypothesized that resistance training combined with a high-protein diet would result in similar short-term weight loss but better long-term weight maintenance than either a conventional low-fat diet control or a high-protein diet alone.
","['Chinese people', 'June 2019 and October 2020', '90 overweight or obese participants']","['resistance training combined with a high-protein diet', 'conventional low-fat diet group, the high-protein diet group and the high-protein diet and resistance training combination group']","['weight loss and weight maintenance', 'similar short-term weight loss', 'body weight change']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0425403', 'cui_str': 'Diet, High-Protein'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",,0.0447371,"We hypothesized that resistance training combined with a high-protein diet would result in similar short-term weight loss but better long-term weight maintenance than either a conventional low-fat diet control or a high-protein diet alone.
","[{'ForeName': 'Shaoyong', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University of PLA, Changle West Road No. 169, Xi'an, 710032, Shaanxi, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, 3201 Hospital of Xi'an Jiao tong University Health Science Center, 783 Tianhan Road, Hanzhong, 723000, Shaanxi, China.""}, {'ForeName': 'Yuxiang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Clinical Nutrition, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang City, 441021, Hubei, China.'}, {'ForeName': 'Ruikun', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, 441021, Hubei, China.'}, {'ForeName': 'Wenlei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, 441021, Hubei, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Tan', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University of PLA, Changle West Road No. 169, Xi'an, 710032, Shaanxi, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, No. 136, Jingzhou Street, Xiangyang, 441021, Hubei, China. linggao048@sina.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': ""Department of Health Statistics, Shaanxi Key Laboratory of Free Radical Biology and Medicine and the Ministry of Education Key Lab of Hazard Assessment and Control in Special Operational Environment, School of Public Health, Air Force Medical University of PLA, Changle West Road No. 169, Xi'an, 710032, Shaanxi, China. shanglei@fmmu.edu.cn.""}]",Trials,['10.1186/s13063-019-3954-7']
522,31915040,Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial.,"BACKGROUND


Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients' general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. Epidural blood patch is the standard treatment for PDPH. However, it is an invasive procedure that may result in rare but serious complications. Recent evidence has suggested that adrenocorticotropic hormone (ACTH) is effective in the management of PDPH. The aim of this study is to assess the efficacy and safety of tetracosactide (Synacthen®), a synthetic analogue of ACTH, for PDPH treatment in patients who receive neuraxial anaesthesia during labour.
METHODS


This randomised, double-blind, placebo-controlled, parallel-arm trial, is performed in two French university hospitals. Eligible patients are those suffering from postpartum PDPH, who are randomised to receive either 1 mg of tetracosactide intravenously over 20 min or to 0.9% saline (placebo). The primary endpoint is the rate of epidural blood patch within a 15-day follow-up period. Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded.
DISCUSSION


We expect a decrease in the use of epidural blood patch in those receiving tetracosactide, thus indicating a decrease in PDPH symptoms in these patients. This will define the therapeutic success of tetracosactide and the possibility to use this treatment as a non-invasive alternative to blood patch for PDPH treatment.
TRIAL REGISTRATION


Primary Registry ClinicalTrials.gov Protocol Registration and Results System Date of Registration 24 June 2016 Unique Protocol ID 69HCL15_0429 Secondary IDs EudraCT Number 2015-003357-17 ClinicalTrials.gov ID NCT02813655 ANSM 160214A-31 Protocol version V4 28/09/2018.",2020,"Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded.
","['post-dural puncture headaches (ESYBRECHE', 'patients who receive neuraxial anaesthesia during labour', 'Eligible patients are those suffering from postpartum PDPH', 'Registration 24 June 2016 Unique Protocol ID 69HCL15_0429 Secondary IDs EudraCT Number 2015-003357-17 ClinicalTrials.gov ID NCT02813655 ANSM 160214A-31', 'two French university hospitals']","['tetracosactide intravenously over 20\u2009min or to 0.9% saline (placebo', 'tetracosactide', 'adrenocorticotropic hormone (ACTH', 'placebo', 'tetracosactide (Synacthen®', 'Epidural blood patch']","['efficacy and safety', 'Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches', 'length of hospital stays', 'PDPH symptoms', 'rate of epidural blood patch']","[{'cui': 'C0751188', 'cui_str': 'Post-Dural Puncture Headaches'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0162649', 'cui_str': 'Patchs, Epidural Blood'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162649', 'cui_str': 'Patchs, Epidural Blood'}]",24.0,0.314895,"Headache duration, pain intensity, reduction of general activity, increase in length of hospital stay, adverse events, analgesic use (type and duration) and number of blood patches per patient in each group are recorded.
","[{'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Depaulis', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Lyon, France. celia.depaulis@gmail.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Steer', 'Affiliation': 'Hospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Léa', 'Initials': 'L', 'LastName': 'Garessus', 'Affiliation': 'Hospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Chassard', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Lyon, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Aubrun', 'Affiliation': 'Hospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon, France.'}]",Trials,['10.1186/s13063-019-4015-y']
523,31915043,Evaluating the effects of an exercise program (Staying UpRight) for older adults in long-term care on rates of falls: study protocol for a randomised controlled trial.,"BACKGROUND


Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively.
METHODS/DESIGN


This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018.
DISCUSSION


This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148.",2020,This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls.,"['Participants (n\u2009=\u2009528 total, with a 1:1 allocation ratio', 'aged care residents', 'Universal trial number U1111-1217-7148', 'LTC residents (age\u2009≥\u200965\u2009years) will be recruited from LTC facilities in New Zealand', '30 November 2018', 'older adults living in long-term care (LTC) than community-dwelling older adults', 'older adults in long-term care on rates of falls']","['progressive strength and balance exercise program', 'exercise program (Staying UpRight', 'novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group']","['rate of falls', 'risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance', 'efficacy and cost-effectiveness', 'Cost-effectiveness']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023977'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C2607857'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.136296,This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls.,"[{'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'The University of Auckland, Faculty of Medical and Health Sciences, Auckland, New Zealand. lm.taylor@auckland.ac.nz.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': 'The University of Auckland, Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Auckland University of Technology, Health and Rehabilitation Research Institute, Auckland, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Binns', 'Affiliation': 'Auckland University of Technology, Health and Rehabilitation Research Institute, Auckland, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': 'Auckland University of Technology, Health and Rehabilitation Research Institute, Auckland, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Edlin', 'Affiliation': 'The University of Auckland, Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Institute of Neuroscience/Newcastle University Institute for Ageing, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Del Din', 'Affiliation': 'Institute of Neuroscience/Newcastle University Institute for Ageing, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klenk', 'Affiliation': 'Institute of Epidemiology and Medical Biometry Ulm, Ulm University, Ulm, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'Institute of Neuroscience/Newcastle University Institute for Ageing, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cavadino', 'Affiliation': 'The University of Auckland, Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Moyes', 'Affiliation': 'The University of Auckland, Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Ngaire', 'Initials': 'N', 'LastName': 'Kerse', 'Affiliation': 'The University of Auckland, Faculty of Medical and Health Sciences, Auckland, New Zealand.'}]",Trials,['10.1186/s13063-019-3949-4']
524,31924365,Assessment of preoperative noninvasive ventilation before lung cancer surgery: The preOVNI randomized controlled study.,"OBJECTIVES


The preOVNI study was a randomized, controlled, open-label study that investigated whether preoperative noninvasive ventilation (NIV) could reduce postoperative complications after lung cancer surgery.
METHODS


Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity were included and randomly assigned to preoperative NIV (at least 7 days and 4 h/day) or no NIV. The primary endpoint was the rate of postoperative protocol-defined complications.
RESULTS


Three hundred patients were included. In the NIV group, the median NIV duration was 8 days. No difference of postoperative complication rates was evidenced: 42.6% in NIV group and 44.8% in no-NIV group (P = .75). The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08). The type of surgery (open or minimally invasive) did not impact these results after multivariable analysis.
CONCLUSIONS


No benefit was evidenced for preoperative NIV before lung cancer surgery. Further studies should determine the optimal perioperative management to decrease the rate of postoperative complications.",2020,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","['before lung cancer surgery', 'Three hundred patients were included', 'Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity', 'after lung cancer surgery']","['preoperative noninvasive ventilation', 'preoperative noninvasive ventilation (NIV']","['rate of postoperative protocol-defined complications', 'postoperative complication rates', 'postoperative complications', 'rate of pneumonia', 'median NIV duration']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",300.0,0.134838,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paleiron', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France; Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France. Electronic address: nicolas.paleiron@intradef.gouv.fr.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Grassin', 'Affiliation': 'Respiratory Disease Unit, HIA Clermont Tonnerre, Brest, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lancelin', 'Affiliation': 'Thoracic Surgery Unit, Clinique du Grand Large, Brest, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': 'Respiratory Disease Unit, HIA Percy, Clamart, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Natale', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.193']
525,31924257,Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol.,"BACKGROUND


In people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface between residual limb and prosthetic socket, where the objectives of sufficient weight distribution and suspension are conflicting with the necessity to facilitate heat exchange and limit contact pressure and friction. Recently, prosthesis liners that contain phase-change material have become commercially available, holding the promise that the micro climate at the interface between the residual limb skin and the prosthetic socket can be regulated to reduce the users' tendency to sweat. Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners. However, the clinical relevance of those findings remains unclear. The purpose of this study is to investigate whether longer (6+ months) periods of use of phase-change material based temperature-control liners have clinically meaningful effects.
METHODS


The protocol is a double-blind longitudinal cross-over research design. A sample of trans-tibial prosthesis users are wearing their regular gel or silicone liners for six months and phase-change material liners for another six months in a randomized sequence. Their prostheses is equipped with activity monitors to detect days when they could not wear their prosthesis. In six-week intervals, individuals' activity, physical performance, and overall prosthesis assessment is recorded using standardized methods.
DISCUSSION


Expected results will inform prescription and reimbursement practice of phase-change material-based prosthesis liners and will help improve and economize prosthetic fitting for people with limb loss. The design and duration of the protocol, including randomization, blinding, and within-subject comparison, will generate scientific evidence of a comparably high level. Inclusion of a comparably large sample and different climates, e.g. across all four seasons, will make findings applicable to a large number of prosthesis users.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03428815. Registered on 12 February 2018.",2020,Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners.,"['people living with limb loss', 'people with limb loss', 'lower limb prosthesis use']","['regular gel or silicone liners', 'temperature-control liner materials', 'phase-change material based temperature-control liners']","[""individuals' activity, physical performance, and overall prosthesis assessment""]","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2607857'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0653702,Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners.,"[{'ForeName': 'Goeran', 'Initials': 'G', 'LastName': 'Fiedler', 'Affiliation': 'Department of Rehabilitation Science and Technology, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA. gfiedler@pitt.edu.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Biomedical Engineering, School of Engineering, Widener University, Chester, PA, USA.'}, {'ForeName': 'Xueyi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Science and Technology, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Trials,['10.1186/s13063-019-3920-4']
526,28412886,"A Long-Term, Open-Label, Safety Study of Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD.","Objective:  The aim of this study was to evaluate the long-term safety of triple-bead mixed amphetamine salts (MAS) in adults with ADHD.  Method:  Adults meeting  Diagnostic and Statistical Manual of Mental Disorders  (4th ed., text rev.;  DSM-IV-TR ) ADHD criteria and satisfying study criteria from one of two antecedent studies were enrolled in this 52-week (dose titration, 4 weeks; dose maintenance, 11 months) open-label extension. The protocol included 12.5- to 75-mg triple-bead MAS but was amended to a maximum of 50-mg triple-bead MAS. Safety evaluations included treatment-emergent adverse events (TEAEs) and vital signs. Clinical outcome measures included ADHD Rating Scale-IV (ADHD-RS-IV) total score changes.  Results:  Of 505 enrolled participants, 266 completed the study; the  M  ±  SD  daily dose during the study was 48.0 ± 15.96 mg. The most frequent TEAEs were insomnia (initial insomnia, insomnia, early morning awakening, middle insomnia; 38.2%), headache (25.7%), and dry mouth (20.2%). Study discontinuations were more frequent with higher doses of triple-bead MAS (37.5-75 mg) than with lower doses (12.5 and 25 mg). Blood pressure and pulse increases were observed at end-of-study. Mean ADHD-RS-IV total score decreases from antecedent study and open-label baselines at end-of-study were -23.3 ± 11.44 and -7.9 ± 13.19, respectively.  Conclusion:  Triple-bead MAS exhibited a long-term safety profile comparable with previous reports and demonstrated evidence of continued symptom control for up to 12 months.",2020,Study discontinuations were more frequent with higher doses of triple-bead MAS (37.5-75 mg) than with lower doses (12.5 and 25 mg).,"['Adults meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev', 'adults with ADHD', '505 enrolled participants', 'Adults With ADHD']","['triple-bead mixed amphetamine salts (MAS', 'Triple-Bead Mixed Amphetamine Salts (SHP465', 'triple-bead MAS']","['Mean ADHD-RS-IV total score', 'treatment-emergent adverse events (TEAEs) and vital signs', 'insomnia (initial insomnia, insomnia, early morning awakening, middle insomnia', 'ADHD Rating Scale-IV (ADHD-RS-IV) total score changes', 'headache', 'Blood pressure and pulse increases']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0393760', 'cui_str': 'Initial insomnia (disorder)'}, {'cui': 'C0541798', 'cui_str': 'Early Awakening'}, {'cui': 'C0393761', 'cui_str': 'Middle insomnia (disorder)'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}]",505.0,0.0238915,Study discontinuations were more frequent with higher doses of triple-bead MAS (37.5-75 mg) than with lower doses (12.5 and 25 mg).,"[{'ForeName': 'Lenard A', 'Initials': 'LA', 'LastName': 'Adler', 'Affiliation': 'New York University, New York City, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Frick', 'Affiliation': 'Shire, Lexington, MA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Endo Pharmaceuticals, Malvern, PA, USA.'}]",Journal of attention disorders,['10.1177/1087054717696770']
527,31915047,"Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial.","BACKGROUND


Labor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery.
METHODS


RE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ≥ 18 years of age at > 37 weeks of gestation who exhibit unfavorable cervical conditions (Bishop score < 6) 24 h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality.
DISCUSSION


This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus.
TRIAL REGISTRATION


Registered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).",2020,"Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening.","['Patients with premature membrane rupture, uterine scars, or multiple pregnancies', '360 patients ≥ 18\u2009years of age at >\u200937\u2009weeks of gestation who exhibit unfavorable cervical conditions (Bishop score\u2009<\u20096) 24\u2009h after placement of the first Propess®, with fetuses in cephalic presentation, will be included', 'six French hospitals', 'women in France']","['oxytocin', 'Prostaglandins, especially intravaginal dinoprostone (Propess®', 'dinoprostone (Propess®', 'oxytocin [Syntocinon®']","['vaginal delivery rate', 'induction failure rates and maternofetal morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus (finding)'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C2979973'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0592155', 'cui_str': 'Syntocinon'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",360.0,0.254695,"Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coste Mazeau', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France. perrine.costemazeau@chu-limoges.fr.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hessas', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Clinical Investigation Center, CHRU Limoges, 2 Avenue Dominique Larrey, 87000, Limoges, France.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Eyraud', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Margueritte', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Aubard', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sallee', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sire', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gauthier', 'Affiliation': ""Department of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.""}]",Trials,['10.1186/s13063-019-3985-0']
528,27521574,Executive Functioning Outcomes Over 6 Months of Atomoxetine for Adults With ADHD: Relationship to Maintenance of Response and Relapse Over the Subsequent 6 Months After Treatment.,"Objective:  This study examines the relationship between maintenance of improved executive functioning (EF) in adults with ADHD with long-term symptom improvement with atomoxetine.  Method:  Data were collected from a yearlong, double-blind, placebo-controlled clinical study on adult patients with ADHD receiving atomoxetine (80-100 mg/day) for 24 weeks. Patients were then randomized to continue atomoxetine or placebo for 6 months. Executive functioning was rated with Behavior Rating Inventory of Executive Function-Adult Version: Self-Report™ (BRIEF-A: Self-Report™), and the  T -scores were determined.  Results:  Postrandomization  T -scores for atomoxetine patients were significantly better than those of placebo patients (3 and 6 months postrandomization). Patients with greater improvements in EF were more likely to show worsening of EF and to relapse after atomoxetine discontinuation. The maintenance of improved EF was significantly associated with improved ADHD symptoms (Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version [CAARS-Inv:SV] with adult prompts).  Conclusion:  Treatment with atomoxetine improved EF during the treatment phases. Improved EF was maintained up to 6 months after discontinuation of atomoxetine.",2020,The maintenance of improved EF was significantly associated with improved ADHD symptoms (Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version,"['Adults With ADHD', 'adults with ADHD with long-term symptom improvement with atomoxetine', '80-100 mg/day) for 24 weeks', 'controlled clinical study on adult patients with ADHD receiving']","['atomoxetine', 'placebo', 'atomoxetine or placebo', 'Atomoxetine']","['executive functioning (EF', 'EF', ""ADHD symptoms (Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version"", 'Executive functioning', 'Executive Functioning Outcomes', 'Behavior Rating Inventory of Executive Function-Adult Version: Self-Report™ (BRIEF-A: Self-Report™), and the T-scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0222045'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3854607', 'cui_str': 'T score'}]",,0.0751686,The maintenance of improved EF was significantly associated with improved ADHD symptoms (Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version,"[{'ForeName': 'Lenard A', 'Initials': 'LA', 'LastName': 'Adler', 'Affiliation': 'New York University Langone Medical Center, New York City, NY, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Solanto', 'Affiliation': 'New York University Langone Medical Center, New York City, NY, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Escobar', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'inVentiv Health Clinical, LLC, Ann Arbor, MI, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Upadhyaya', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of attention disorders,['10.1177/1087054716664411']
529,31629621,"A Prospective Randomized Study Comparing Postoperative Pain, Biological Fixation, and Clinical Outcomes Between Two Uncemented Rotating Platform Tibial Tray Designs.","BACKGROUND


With the demand for arthroplasty increasing worldwide year on year, there is a drive to improve prosthesis longevity. Biological fixation from cementless implants has been one method of trying to achieve this. We hypothesized that the addition of a hydroxyapatite (HA) coating and 4 pegs to a porous-coated tibial tray would provide a reduction in time to implant osseointegration, allowing for normal physiological stress transfer, thus improving early postoperative pain and rehabilitation as well as the elimination of radiolucent lines (RLLs).
METHODS


A prospective, randomized controlled single-blinded study was undertaken, comparing postoperative pain, radiographic evidence of biological fixation, and clinical outcomes between patients undergoing primary total knee arthroplasty with either LCS Complete POROCOAT (porous coating only) or LCS Complete DUOFIX (porous coating plus HA and pegs) knee systems (DePuy Synthes, Warsaw, IN). In total, 197 patients (205 knees) were recruited into the study between November 2006 and November 2008 and have been followed for up to 10 years.
RESULTS


There were no clinically significant differences in pain or patient-reported outcome measures when comparing the 2 designs but the tibial tray with pegs and HA showed fewer RLLs at all time points. There was no correlation between RLLs and pain and no instances of loosening or osteolysis in either group. There was 1 revision for infection in the porous coating only group.
CONCLUSION


The tray design with HA and additional fixation pegs did not confer any benefit in terms of reduced early postoperative pain or improved patient-reported outcomes, although it did result in significantly fewer RLLs. Both implants demonstrated excellent survivorship. With a cementless porous-coated tibial component, nonprogressive RLLs should be considered normal.",2020,There were no clinically significant differences in pain or patient-reported outcome measures when comparing the 2 designs but the tibial tray with pegs and HA showed fewer RLLs at all time points.,"['patients undergoing primary total knee arthroplasty with either', '197 patients (205 knees) were recruited into the study between November 2006 and November 2008 and have been followed for up to 10 years']","['hydroxyapatite (HA) coating', 'LCS Complete POROCOAT (porous coating only) or LCS Complete DUOFIX (porous coating plus HA and pegs']","['Postoperative Pain, Biological Fixation, and Clinical Outcomes', 'loosening or osteolysis', 'early postoperative pain', 'excellent survivorship', 'pain', 'RLLs and pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C0221204', 'cui_str': 'Osteolysis'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0038955'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",197.0,0.0705154,There were no clinically significant differences in pain or patient-reported outcome measures when comparing the 2 designs but the tibial tray with pegs and HA showed fewer RLLs at all time points.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hegarty', 'Affiliation': 'Outcomes Department, Musgrave Park Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walls', 'Affiliation': 'Outcomes Department, Musgrave Park Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Outcomes Department, Musgrave Park Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gamble', 'Affiliation': 'Outcomes Department, Musgrave Park Hospital, Belfast, United Kingdom.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Cusick', 'Affiliation': 'Outcomes Department, Musgrave Park Hospital, Belfast, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Beverland', 'Affiliation': 'Outcomes Department, Musgrave Park Hospital, Belfast, United Kingdom.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.09.029']
530,31907017,A cluster randomized clinical trial to evaluate the effectiveness of the Implementation of Infant Pain Practice Change (ImPaC) Resource to improve pain practices in hospitalized infants: a study protocol.,"BACKGROUND


Hospitalized infants undergo multiple painful procedures daily. Despite the significant evidence, procedural pain assessment and management continues to be suboptimal. Repetitive and untreated pain at this vital developmental juncture is associated with negative behavioral and neurodevelopmental consequences. To address this knowledge to practice gap, we developed the web-based Implementation of Infant Pain Practice Change (ImPaC) Resource to guide change in healthcare professionals' pain practice behaviors. This protocol describes the evaluation of the intervention effectiveness and implementation of the Resource and how organizational context influences outcomes.
METHODS


An effectiveness-implementation hybrid type 1 design, blending a cluster randomized clinical trial and a mixed-methods implementation study will be used. Eighteen Neonatal Intensive Care Units (NICUs) across Canada will be randomized to intervention (INT) or standard practice (SP) groups. NICUs in the INT group will receive the Resource for six months; those in the SP group will continue with practice as usual and will be offered the Resource after a six-month waiting period. Data analysts will be blinded to group allocation. To address the intervention effectiveness, the INT and SP groups will be compared on clinical outcomes including the proportion of infants who have procedural pain assessed and managed, and the frequency and nature of painful procedures. Data will be collected at baseline (before randomization) and at completion of the intervention (six months). Implementation outcomes (feasibility, fidelity, implementation cost, and reach) will be measured at completion of the intervention. Sustainability will be assessed at six and 12 months following the intervention. Organizational context will be assessed to examine its influence on intervention and implementation outcomes.
DISCUSSION


This mixed-methods study aims to determine the effectiveness and the implementation of a multifaceted online strategy for changing healthcare professionals' pain practices for hospitalized infants. Implementation strategies that are easily and effectively implemented are important for sustained change. The results will inform healthcare professionals and decision-makers on how to address the challenges of implementing the Resource within various organizational contexts.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03825822. Registered 31 January 2019.",2020,This mixed-methods study aims to determine the effectiveness and the implementation of a multifaceted online strategy for changing healthcare professionals' pain practices for hospitalized infants.,"['Hospitalized infants undergo multiple painful procedures daily', 'Eighteen Neonatal Intensive Care Units (NICUs) across Canada', 'hospitalized infants']","['Infant Pain Practice Change (ImPaC) Resource', 'multifaceted online strategy']","['pain practices', 'Implementation outcomes (feasibility, fidelity, implementation cost, and reach']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",,0.147551,This mixed-methods study aims to determine the effectiveness and the implementation of a multifaceted online strategy for changing healthcare professionals' pain practices for hospitalized infants.,"[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Bueno', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Stevens', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada. bonnie.stevens@sickkids.ca.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Barwick', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Shirine', 'Initials': 'S', 'LastName': 'Riahi', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Shelly-Anne', 'Initials': 'SA', 'LastName': 'Li', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Lanese', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': 'University of British Columbia, Pediatrics, Rm. 1N18, 4480 Oak Street, Vancouver, British Columbia, V6H 3V4, Canada.'}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Estabrooks', 'Affiliation': 'University of Alberta, Edmonton Health Clinic Academy, Rm 5-006 11405 87 Avenue NW, T6G 1C9, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Chambers', 'Affiliation': 'Departments of Pediatrics and Psychology & Neuroscience, Dalhousie University and Centre for Pediatric Pain Research, IWK Health Centre, P.O. Box 9700 5850-5980 University Ave, Halifax, Nova Scotia, B3K 6R8, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Harrison', 'Affiliation': ""School of Nursing, Faculty of Health Sciences, University of Ottawa, and Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, K1H 8L1, Canada.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Yamada', 'Affiliation': 'Ryerson University, Daphne Cockwell School of Nursing, 350 Victoria Street, Toronto, Ontario, M5B 2K3, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Campbell-Yeo', 'Affiliation': 'School of Nursing, Faculty of Health, Departments of Pediatrics and Psychology & Neuroscience, Dalhousie University and Centre for Pediatric Pain Research, IWK Health Centre, 5869 University Ave, Halifax, B3H 4R2, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Noel', 'Affiliation': 'Department of Psychology, University of Calgary, Psychology, Rm. 260, Administration Building, 539 Campus Place NW, T2N 4V8, Calgary, Canada.'}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Gibbins', 'Affiliation': 'Trillium Health Partners, Professional Practice, 2200 Eglinton Ave W, Mississauga, Ontario, L5M 2N1, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'LeMay', 'Affiliation': ""Université de Montréal, Faculty of Nursing and CHU Sainte-Justine's Research Centre, 3175 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec, H3T 1C5, Canada.""}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College Street, M5T 3M7, Toronto, Canada.'}]",Trials,['10.1186/s13063-019-3782-9']
531,31907033,The effectiveness of negative-pressure wound therapy for wound healing after stoma reversal: a randomised control study (SR-PICO study).,"BACKGROUND


Although the wound-healing period for purse-string closure (PSC) after stoma reversal is longer than that required for the primary closure method, the rate of wound infection is reduced. The application of negative-pressure wound therapy (NPWT) can reduce the healing period for many types of wounds. Herein, we describe a planned trial to test the hypothesis that NPWT can reduce the healing period for PSC after stoma reversal.
METHODS/DESIGN


Patients undergoing stoma reversal will be recruited and allocated into intervention and control groups, with 1:1 randomisation. Patients in the control group will receive standard postsurgical wound care; patients in the intervention group will receive NPWT using the PICO™ system. The target sample size will be 38 patients, as this will provide 80% power at the 5% level of significance to detect a 7-day reduction in the wound-healing period in the intervention group compared to that in the control group. The primary endpoint will be the duration to wound healing, defined as the time to nearly complete epithelisation of the wound, without any discharge or surgical site infection (SSI). Secondary endpoints will be the SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores.
DISCUSSION


The results of this planned randomised controlled study will clarify the role of NPWT in patients undergoing stoma reversal and strengthen the rationale for choosing a dressing technique.
TRIAL REGISTRATION


Clinical Research Information Service (CRIS), KCT0004063. Registered on 6 June 2019.",2020,"Secondary endpoints will be the SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores.
","['patients undergoing stoma reversal', 'Patients undergoing stoma reversal', 'wound healing after stoma reversal']","['negative-pressure wound therapy', 'NPWT', 'NPWT using the PICO™ system', 'standard postsurgical wound care', 'negative-pressure wound therapy (NPWT']","['SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores', 'duration to wound healing, defined as the time to nearly complete epithelisation of the wound, without any discharge or surgical site infection (SSI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0574776', 'cui_str': 'Wound healed (finding)'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound (procedure)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}]",,0.0476565,"Secondary endpoints will be the SSI rate, length of postoperative hospital stay, number of wound dressings and visits to the hospital for wound dressing after discharge, total cost of wound dressings, and patient and observer scar assessment scale scores.
","[{'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University College of Medicine, 170 Hyeonchung-ro, Nam-gu, Daegu, 42415, South Korea.'}, {'ForeName': 'Sung Il', 'Initials': 'SI', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Yeungnam University Medical Center, Yeungnam University College of Medicine, 170 Hyeonchung-ro, Nam-gu, Daegu, 42415, South Korea. sungiry@naver.com.'}]",Trials,['10.1186/s13063-019-3925-z']
532,31472003,Cost-effectiveness in transient hypocalcemia post-thyroidectomy.,"BACKGROUND


Three different strategies to manage transient hypocalcemia after total thyroidectomy were compared to evaluate cost-effectiveness. The reliability of total serum calcium (TSCa), ionized calcium (ICa), and intact parathyroid hormone (iPTH) were investigated to achieve this goal.
METHODS


A multicenter, prospective randomized study was carried out with 169 patients. The strategies were ""preventive"" (oral calcium + vitamin D supplementation), ""reactive"" (therapy in hypocalcemia), and ""predictive"" (therapy if iPTH <10 pg/mL).
RESULTS


TSCa had higher accuracy in identifying patients who developed hypocalcemia-related symptoms than ICa (84.6% vs 50.0%). TSCa 24 h after surgery showed 24.8% of patients with hypocalcemia, whereas TSCa 48 h after surgery identified a further 10.6% with hypocalcemia (only in the ""reactive"" and ""predictive"" groups). iPTH showed low sensitivity as a predictor of hypocalcemia. Between the 3 groups, there was no significant difference in hospitalization time or number of symptomatic hypocalcemic patients. Interestingly, the cost-per-patient was significantly different among the groups.
CONCLUSIONS


None of the discussed strategies allowed for early discharge of patients without any risk of transient hypocalcemia. The ""preventive"" strategy was the most cost-effective, despite overtreatment.",2019,"TSCa 24 h after surgery showed 24.8% of patients with hypocalcemia, whereas TSCa 48 h after surgery identified a further 10.6% with hypocalcemia (only in the ""reactive"" and ""predictive"" groups).",['169 patients'],"['TSCa', 'preventive"" (oral calcium\u2009+\u2009vitamin D supplementation), ""reactive"" (therapy in hypocalcemia), and ""predictive"" (therapy if iPTH <10 pg/mL']","['hypocalcemia', 'Cost-effectiveness', 'hospitalization time', 'reliability of total serum calcium (TSCa), ionized calcium (ICa), and intact parathyroid hormone (iPTH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}]","[{'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}]",,0.0328907,"TSCa 24 h after surgery showed 24.8% of patients with hypocalcemia, whereas TSCa 48 h after surgery identified a further 10.6% with hypocalcemia (only in the ""reactive"" and ""predictive"" groups).","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mercante', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anelli', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Giannarelli', 'Affiliation': 'Department of Biostatistics and Bioinformatics, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Giordano', 'Affiliation': 'Otolaryngology Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Sinopoli', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ferreli', 'Affiliation': 'Otorhinolaryngology Unit, Humanitas Clinical and Research Center-IRCCS, Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Digiesi', 'Affiliation': 'Clinical Pathology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Appetecchia', 'Affiliation': 'Endocrinology Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Agnese', 'Initials': 'A', 'LastName': 'Barnabei', 'Affiliation': 'Endocrinology Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cristalli', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Conti', 'Affiliation': 'Clinical Pathology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Pellini', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piazza', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, ""Carlo Poma"" Civil Hospital, Mantua, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Lombardi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'De Virgilio', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Spriano', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}]",Head & neck,['10.1002/hed.25934']
533,31922999,Effect of Midazolam in Addition to Propofol and Opiate Sedation on the Quality of Recovery After Colonoscopy: A Randomized Clinical Trial.,"BACKGROUND


There is a concern that midazolam, when used as a component of sedation for colonoscopy, may impair cognition and prolong recovery. We aimed to identify whether midazolam produced short- and longer-term effects on multiple dimensions of recovery including cognition.
METHODS


A 2-center double-blinded, placebo-controlled, parallel-group, randomized, phase IV study with a 1:1 allocation ratio was conducted in adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS). Participants were administered either midazolam (0.04 mg·kg) or an equivalent volume of 0.9% saline before sedation with propofol with or without an opiate. The primary outcome was incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy, which was analyzed using a χ test. Secondary outcomes included recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction. All hypotheses were defined before recruitment.
RESULTS


During September 2015 to June 2018, 406 patients were allocated to either midazolam (n = 201) or placebo (n = 205), with one withdrawn before allocation. There was no significant difference in recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy (midazolam 86.8% vs placebo 88.7%, odds ratio, 0.838; 95% confidence interval [CI], 0.42-1.683; P= .625). Furthermore, there was no difference in recovery over time in the cognitive domain of the PostopQRS (P = .534). Overall recovery of the PostopQRS increased over time but was not different between groups. Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS. Patient and endoscopist satisfaction were high and not different. There were no differences in time to eye-opening (midazolam 9.4 ± 12.8 minutes vs placebo 7.3 ± 0.7 minutes; P = .055), or time to hospital discharge (midazolam 103.4 ± 1.4 minutes vs placebo 98.4 ± 37.0 minutes; P = .516).
CONCLUSIONS


The addition of midazolam 0.04 mg·kg as adjunct to propofol and opiate sedation for elective colonoscopy did not show evidence of any significant differences in recovery in the cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times. The use of midazolam should be determined by the anesthesiologist.",2020,"Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS.","['During September 2015 to June 2018, 406 patients', 'adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS']","['midazolam', 'equivalent volume of 0.9% saline before sedation with propofol with or without an opiate', 'Midazolam', 'placebo', 'Propofol and Opiate Sedation']","['Overall recovery of the PostopQRS', 'recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction', 'nociceptive, emotive, activities-of-daily-living domains of the PostopQRS', 'cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times', 'incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy', 'time to hospital discharge', 'Patient and endoscopist satisfaction', 'cognitive domain of the PostopQRS', 'time to eye-opening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0376245', 'cui_str': 'English language (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0222045'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",406.0,0.627951,"Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS.","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Gurunathan', 'Affiliation': 'From the *The Prince Charles Hospital, Brisbane, Queensland, Australia †University of Queensland, Brisbane, Queensland, Australia ‡Queensland University of Technology and University of Sunshine Coast, Queensland, Australia §Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia ‖Department of Anesthesia and Pain Management, The Royal Melbourne Hospital, Melbourne, Victoria, Australia ¶Outcomes Research Consortium, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Rahman', 'Affiliation': ''}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vandeleur', 'Affiliation': ''}, {'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Sriram', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Harch', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Boggett', 'Affiliation': ''}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bowyer', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004620']
534,31944487,Neurocognitive effects of transcranial direct current stimulation (tDCS) in unipolar and bipolar depression: Findings from an international randomized controlled trial.,"OBJECTIVE


Transcranial direct current stimulation (tDCS) has been found to have antidepressant effects and may have beneficial neurocognitive effects. However, prior research has produced an unclear understanding of the neurocognitive effects of repeated exposure to tDCS. The study's aim was to determine the neurocognitive effects following tDCS treatment in participants with unipolar or bipolar depression.
METHOD


The study was a triple-masked, randomized, controlled clinical trial across six international academic medical centers. Participants were randomized to high dose (2.5 mA for 30 min) or low dose (0.034 mA, for 30 min) tDCS for 20 sessions over 4 weeks, followed by an optional 4 weeks of open-label high dose treatment. The tDCS anode was centered over the left dorsolateral prefrontal cortex at F3 (10/20 EEG system) and the cathode over F8. Participants completed clinical and neurocognitive assessments before and after tDCS. Genotype (BDNF Val66Met and catechol-o-methyltransferase [COMT] Val158Met polymorphisms) were explored as potential moderators of neurocognitive effects.
RESULTS


The study randomized 130 participants. Across the participants, tDCS treatment (high and low dose) resulted in improvements in verbal learning and recall, selective attention, information processing speed, and working memory, which were independent of mood effects. Similar improvements were observed in the subsample of participants with bipolar disorder. There was no observed significant effect of tDCS dose. However, BDNF Val66Met and COMT Val158Met polymorphisms interacted with tDCS dose and affected verbal memory and verbal fluency outcomes, respectively.
CONCLUSIONS


These findings suggest that tDCS could have positive neurocognitive effects in unipolar and bipolar depression. Thus, tDCS stimulation parameters may interact with interindividual differences in BDNF and COMT polymorphisms to affect neurocognitive outcomes, which warrants further investigation.",2020,"Across the participants, tDCS treatment (high and low dose) resulted in improvements in verbal learning and recall, selective attention, information processing speed, and working memory, which were independent of mood effects.","['participants with unipolar or bipolar depression', 'unipolar and bipolar depression', '130 participants', 'six international academic medical centers']","['Genotype', 'transcranial direct current stimulation (tDCS', 'tDCS', 'Transcranial direct current stimulation (tDCS']","['positive neurocognitive effects', 'verbal learning and recall, selective attention, information processing speed, and working memory, which were independent of mood effects', 'verbal memory and verbal fluency outcomes', 'neurocognitive effects']","[{'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",130.0,0.170401,"Across the participants, tDCS treatment (high and low dose) resulted in improvements in verbal learning and recall, selective attention, information processing speed, and working memory, which were independent of mood effects.","[{'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Donel M', 'Initials': 'DM', 'LastName': 'Martin', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Division of Brain Stimulation and Neurophysiology, Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'McDonald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Department of Clinical Research Programs, Sheppard Pratt Health System, Baltimore, Maryland.'}, {'ForeName': 'Mustafa M', 'Initials': 'MM', 'LastName': 'Husain', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': ""O'Reardon"", 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Mood Disorders and Neuromodulation Therapies, Rowan University School of Osteopathic Medicine, Cherry Hill, New Jersey.'}, {'ForeName': 'Cynthia Shannon', 'Initials': 'CS', 'LastName': 'Weickert', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Adith', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'School of Psychiatry, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'Loo', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}]",Depression and anxiety,['10.1002/da.22988']
535,30193564,Impact of telemedicine on the clinical outcomes and healthcare costs of patients with chronic heart failure and mid-range or preserved ejection fraction managed in a multidisciplinary chronic heart failure programme: A sub-analysis of the iCOR randomized trial.,"Background


The efficacy of telemedicine in the management of patients with chronic heart failure and left ventricular ejection fraction ≥40% is poorly understood. The aim of our analysis was to evaluate the efficacy of a telemedicine-based intervention specifically in these patients, as compared to standard of care alone.
Methods


The Insuficiència Cardiaca Optimització Remota (iCOR) study was a single centre, randomised, controlled trial, designed to evaluate a telemedicine intervention added to an existing hospital/primary care multidisciplinary, integrated programme for chronic heart failure patients. 178 participants were randomised to telemedicine or usual care, and were followed for six months. For the present sub-analysis, only iCOR participants (n = 116) with left ventricular ejection fraction ≥40% were included. The primary study endpoint was the incidence of an acute non-fatal heart failure event, defined as a new episode of worsening of symptoms and signs consistent with acute heart failure requiring intravenous diuretic therapy. The healthcare-related costs in each study group were also evaluated.
Results


The incidence of the first occurrence of the primary endpoint was significantly lower in the telemedicine arm (22% vs 56%, p<0.001), with a hazard ratio of 0.33 comparing to the usual care arm (95% confidence interval 0.17–0.64). Telemedicine was also associated with lower mean overall chronic heart failure care-related costs compared to usual care (8163€ vs 4993€, p=0.001). The results were consistent in both left ventricular ejection fraction of 40–49% and left ventricular ejection fraction ≥50% patients.
Conclusions


Our results suggest that telemedicine is a promising strategy for the management of chronic heart failure patients with left ventricular ejection fraction ≥40%. These findings should be replicated in larger cohorts.",2020,The results were consistent in both left ventricular ejection fraction of 40-49% and left ventricular ejection fraction ≥50% patients.,"['178 participants', 'iCOR participants (n\u2009=\u2009116) with left ventricular ejection fraction ≥40% were included', 'chronic heart failure patients with left ventricular ejection fraction ≥40', 'patients with chronic heart failure and mid-range or preserved ejection fraction managed in a multidisciplinary chronic heart failure programme', 'patients with chronic heart failure and left ventricular ejection fraction ≥40', 'chronic heart failure patients']","['Telemedicine', 'telemedicine or usual care', 'telemedicine', 'telemedicine intervention', 'telemedicine-based intervention']","['left ventricular ejection fraction', 'incidence of an acute non-fatal heart failure event, defined as a new episode of worsening of symptoms and signs consistent with acute heart failure requiring intravenous diuretic therapy']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]",178.0,0.0566359,The results were consistent in both left ventricular ejection fraction of 40-49% and left ventricular ejection fraction ≥50% patients.,"[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Jiménez-Marrero', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Yun', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cainzos-Achirica', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Enjuanes', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Garay', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Farre', 'Affiliation': 'Heart Failure Unit, Hospital del Mar, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Verdú', 'Affiliation': 'Department of Medicine, Universitat Autònoma de Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Linas', 'Affiliation': 'Heart Failure Unit, Hospital del Mar, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Ruiz', 'Affiliation': 'Heart Failure Unit, Hospital del Mar, Spain.'}, {'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Hidalgo', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Calero', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': 'Community Heart Failure Program, Bellvitge University Hospital, Spain.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18796439']
536,31523848,Repeat Annual Colorectal Cancer Screening in Rural Community Clinics: A Randomized Clinical Trial to Evaluate Outreach Strategies to Sustain Screening.,"PURPOSE


The majority of colorectal cancer (CRC) research using the fecal immunochemical test (FIT) has studied short-term screening results in predominantly urban areas. The purpose of this study was to evaluate the effectiveness of 2 outreach strategies embedded in a health literacy intervention on repeat CRC screening in rural community clinics.
METHODS


A 2-arm randomized controlled trial was conducted in 4 rural clinics in Louisiana. During a regularly scheduled clinic visit, participants ages 50-75 received a FIT kit and brief educational intervention. Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned. In year 2, materials were mailed, and follow-up calls were conducted as in year 1. The primary outcome was repeat FIT-the return of the FIT kit in both years.
PARTICIPANTS


Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy.
FINDINGS


Repeat FIT rates were 36.5% for those receiving the automated call and 33.6% for those receiving a personal call (P = .30). No annual FITs were returned in 30% of participants, while only 1 FIT was returned by 35% of participants (31% only year 1 and 4% only year 2).
CONCLUSION


Sustaining CRC screening with FIT is challenging in rural clinics. A lower cost automated call was just as effective as the personal call in promoting repeat annual screening. However, more intensive strategies are needed to improve long-term FIT screening among rural participants.",2020,Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned.,"['rural community clinics', '4 rural clinics in Louisiana', 'rural participants', 'Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy', 'Rural Community Clinics']","['automated call or a personal call by a prevention counselor', 'health literacy intervention', 'FIT kit and brief educational intervention']","['annual FITs', 'repeat FIT-the return of the FIT kit in both years']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",568.0,0.0671545,Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned.,"[{'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventive Medicine and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Laurie Anne', 'Initials': 'LA', 'LastName': 'Ferguson', 'Affiliation': 'College of Nursing and Health, Loyola University, New Orleans, Louisiana.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Clinic, Franklin, Louisiana.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12399']
537,31553119,Comparative study of efficacy and safety of 45% mandelic acid versus 30% salicylic acid peels in mild-to-moderate acne vulgaris.,"BACKGROUND


Chemical peels have become a popular modality in the treatment of acne vulgaris (AV). Mandelic acid (MA) is a new emerging peeling agent for AV owing to its antibacterial and anti-inflammatory properties. Hence, it is worthwhile to evaluate the effectiveness and safety profile of this newer agent and to compare it with an older established peeling agent, salicylic acid (SA) in the treatment of AV.
OBJECTIVE


Comparison between therapeutic efficacy and safety of 45% MA peel with 30% SA peel in Indian patients suffering from mild-to-moderate facial AV.
METHODS


A total of 50 patients suffering from mild-to-moderate AV were randomly divided into two groups, with one receiving 30% SA peels and the other receiving 45% MA peels at an interval of 2 weeks for six sessions. Total duration of the study was 12 weeks. Michaelsson acne scores (MAS) and clinical photographs were used to evaluate the efficacy of therapy objectively. Adverse effects of both the agents were also noted at each visit.
RESULTS


Both agents showed almost equal efficacy in improving mild-to-moderate AV. Salicylic acid was found better in treating noninflammatory lesions, while MA had an upper hand in treating inflammatory lesions. Overall, there was no significant difference between the two peels in improving MAS and percentage decrease in MAS. However, adverse effects were lesser with MA peels.
CONCLUSION


About 45% MA peel was found to be equally effective as 30% SA peel in mild-to-moderate facial AV. However, safety and tolerability of MA peel were better than SA peel.",2020,"Overall, there was no significant difference between the two peels in improving MAS and percentage decrease in MAS.","['Indian patients suffering from mild-to-moderate facial AV', '50 patients suffering from mild-to-moderate AV', 'mild-to-moderate acne vulgaris']","['45% mandelic acid versus 30% salicylic acid peels', 'one receiving 30% SA peels and the other receiving 45% MA peels', 'Mandelic acid (MA', 'Salicylic acid', '45% MA peel with 30% SA peel', 'salicylic acid (SA']","['MAS', 'Total duration', 'efficacy and safety', 'safety and tolerability of MA peel', 'Michaelsson acne scores (MAS', 'adverse effects', 'Adverse effects']","[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}]","[{'cui': 'C0024685', 'cui_str': 'Mandelic Acids'}, {'cui': 'C0036080', 'cui_str': 'Salicylic Acids'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",50.0,0.0155382,"Overall, there was no significant difference between the two peels in improving MAS and percentage decrease in MAS.","[{'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Dayal', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pt. B. D. Sharma University of Health Sciences, Rohtak, India.'}, {'ForeName': 'Kirti Dudeja', 'Initials': 'KD', 'LastName': 'Kalra', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pt. B. D. Sharma University of Health Sciences, Rohtak, India.'}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pt. B. D. Sharma University of Health Sciences, Rohtak, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13168']
538,31571339,Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study.,"BACKGROUND


Recurrent trigeminal neuralgia (RTN) is a common clinical problem and pain recurs in many patients after microvascular decompression (MVD). We evaluated the effect of adding pulsed radiofrequency to radiofrequency thermocoagulation at 60°C compared to radiofrequency thermocoagulation at 70°C alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression.
METHODS


40 patients with recurrent trigeminal neuralgia after microvascular decompression were randomly divided into two equal groups. Group A: received prolonged duration of pulsed radiofrequency followed by less destructive thermocoagulation, while group B: received sole thermocoagulation. Then patients followed up for 2 years to evaluate the success rate by the Barrow Neurological Institute Pain Intensity (BNI) Scale, complications, and the need to medical treatment.
RESULTS


The success rate was 100% in both groups at discharge (BNI < III). It was 83.3% and 78.7% after 6 months, 77.8% and 68.4% after 12 month, 72.2% and 68.4% after 18 months and 66.7% and 63.1% after 24 months in group A and B, respectively (p > .05). In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p = .32). 88.9% compared to 89.5% % in group A and B, respectively, did not use tricyclic antidepressant (p = .61). The overall complications in group A was 5.61%, while it was 36.8% in group B (p = .025).
CONCLUSION


Combined pulsed and thermal radiofrequency can significantly reduce the incidence of the side effects/complications with similar success rate than using thermal radiofrequency alone in treatment of recurrent trigeminal neuralgia after microvascular decompression.",2020,In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p=0.32).,"['recurrent trigeminal neuralgia after microvascular decompression', '40 patients with recurrent trigeminal neuralgia after microvascular decompression', 'patients after microvascular decompression (MVD']","['Combined pulsed and thermal radiofrequency', 'radiofrequency thermocoagulation at 70 ºC alone', 'thermal radiofrequency alone', 'Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone', 'pulsed radiofrequency to radiofrequency thermocoagulation', 'prolonged duration of pulsed radiofrequency followed by less destructive thermocoagulation, while group B: received sole thermocoagulation']","['success rate by the Barrow Neurological Institute Pain Intensity (BNI) Scale, complications, and the need to medical treatment', 'success rate', 'overall complications']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040997', 'cui_str': 'Fothergill Disease'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0233520', 'cui_str': 'Destructive behavior (finding)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",40.0,0.0184994,In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p=0.32).,"[{'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelraheem M', 'Initials': 'AM', 'LastName': 'Elawamy', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Hasan', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Nagwa M', 'Initials': 'NM', 'LastName': 'Osman', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelrady S', 'Initials': 'AS', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Aly', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelhady S', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Gamal M', 'Initials': 'GM', 'LastName': 'Abodahab', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Qena University, Qena, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1489']
539,31577041,Short-term effects of hyaluronic acid on the subgingival microbiome in peri-implantitis: A randomized controlled clinical trial.,"BACKGROUND


The aim of our study was to evaluate the effects of a hyaluronic acid (HA) gel at 45 days on the microbiome of implants with peri-implantitis with at least 1 year of loading.
METHODS


A randomized controlled trial was conducted in peri-implantitis patients. Swabs containing the samples were collected both at baseline and after 45 days of treatment. 16S rRNA sequencing techniques were used to investigate the effect of HA gel on the subgingival microbiome.
RESULTS


One hundred and eight samples of 54 patients were analyzed at baseline and after follow-up at 45 days. Three strata with different microbial composition were obtained in the samples at baseline, representing three main microbial consortia associated with peri-implantitis. Stratum 1 did not show any difference for any variable after treatment with HA, whereas in stratum 2, Streptococcus, Veillonella, Rothia, and Granulicatella did decrease (P < 0.05). Similarly, Prevotella and Campylobacter (P < 0.05) decreased in stratum 3 after treatment with HA. Microbial diversity was found to be decreased in stratum 3 (P < 0.05) after treatment with HA compared with the control group, in which an increase was found (P < 0.05).
CONCLUSIONS


HA reduced the relative abundance of peri-implantitis-related microorganisms, especially the early colonizing bacteria, suggesting a specific action during the first stages in the development of the disease. HA did not alter relative abundances of non-oral genera. The use of HA in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.",2020,"The use of hyaluronic acid in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.","['implants with peri-implantitis with at least one year of loading', 'peri-implantitis patients', 'peri-implantitis', '108 samples of 54 patients']","['hyaluronic acid', 'hyaluronic acid gel', 'Hyaluronic acid']","['microbial alpha diversity', 'Microbial diversity', 'relative abundances of non-oral genera']","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.129597,"The use of hyaluronic acid in advanced stages of peri-implantitis resulted in a decrease in microbial alpha diversity, suggesting a protective action of the peri-implant site against bacteria colonization.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soriano-Lerma', 'Affiliation': 'Department of Physiology (Faculty of Pharmacy, Campus Universitario de Cartuja), Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Magán-Fernández', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gijón', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sánchez-Fernández', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Soriano', 'Affiliation': 'GENYO, Centre for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, PTS Granada, Granada, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'García-Salcedo', 'Affiliation': 'Microbiology Unit, Biosanitary Research Institute ibs.GRANADA, University Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mesa', 'Affiliation': 'Department of Periodontics, School of Dentistry, University of Granada, Granada, Spain.'}]",Journal of periodontology,['10.1002/JPER.19-0184']
540,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8']
541,31910872,Pilates and dance to patients with breast cancer undergoing treatment: study protocol for a randomized clinical trial - MoveMama study.,"BACKGROUND


Breast cancer is a global public health issue. The side effects of the clinical treatment can decrease the quality of life of these women. Therefore, a healthy lifestyle is essential to minimize the physical and psychological side effects of treatment. Physical activity has several benefits for women with breast cancer, and Pilates solo and belly dancing can be an enjoyable type of physical activity for women with breast cancer undergoing clinical treatment. The purpose of this study is to provide a Pilates solo and a belly dance protocol (three times per week/16 weeks) for women undergoing breast cancer treatment and compare its effectiveness with that in the control group.
METHODS


The participants will be allocated to either the intervention arm (Pilates solo or belly dance classes three times per week for 16 weeks) or a control group (receipt of a booklet on physical activity for patients with breast cancer and maintenance of habitual physical activity routine). The Pilates solo and belly dance classes will be divided into three stages: warmup and stretching, the main stage, and relaxation. Measurements of the study outcomes will take place at baseline; postintervention; and 6, 12, and 24 months after the end of the intervention (maintenance period). The data collection for both groups will occur with a paper questionnaire and tests covering general and clinical information. The primary outcome will be quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image After Breast Cancer Questionnaire), self-esteem (Rosenberg), fatigue (FACT-F), pain (VAS), sexual function (FSFI), and sleep quality (Pittsburgh Sleep Quality Index).
DISCUSSION


In view of the high prevalence of breast cancer among women, the implementation of a specific protocol of Pilates solo and belly dancing for patients with breast cancer is important, considering the necessity to improve their physical and psychological quality of life. Pilates solo and belly dancing are two types of physical activity that involve mental and physical concentration, music, upper limb movements, femininity, and social involvement. An intervention with these two physical activities could offer options of supportive care to women with breast cancer undergoing treatment, with the aim being to improve physical and psychological quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03194997. Registration date 12 August 2017. Universal Trial Number (World Health Organization), U1111-1195-1623.",2020,"The primary outcome will be quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image","['women with breast cancer undergoing clinical treatment', 'patients with breast cancer undergoing treatment', 'patients with breast cancer', 'women with breast cancer', 'patients with breast cancer and maintenance of habitual physical activity routine', 'women undergoing breast cancer treatment', 'women with breast cancer undergoing treatment']",['intervention arm (Pilates solo or belly dance classes three times per week for 16\u2009weeks) or a control group (receipt of a booklet on physical activity'],"['physical and psychological quality of life', 'quality of life', 'quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image', 'self-esteem (Rosenberg), fatigue (FACT-F), pain (VAS), sexual function (FSFI), and sleep quality (Pittsburgh Sleep Quality Index']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}]",12.0,0.0425438,"The primary outcome will be quality of life (EORT QLQ-C30 and EORT QLQ-BR23), and secondary outcomes will be physical aspects such as cardiorespiratory fitness (6-min walk test and cycle ergometer), lymphedema (sum of arm circumference), physical activity (IPAQ short version), disabilities of the arm (DASH), range of motion (goniometer test), muscular strength (dynamometer test) and flexibility (sit and reach test), and psychological aspects such as depressive symptoms (Beck Depression Inventory), body image (Body Image","[{'ForeName': 'Leonessa', 'Initials': 'L', 'LastName': 'Boing', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil. leonessaboing@gmail.com.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'do Bem Fretta', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'de Carvalho Souza Vieira', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Gustavo Soares', 'Initials': 'GS', 'LastName': 'Pereira', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Moratelli', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Fabiana Flores', 'Initials': 'FF', 'LastName': 'Sperandio', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Baptista', 'Affiliation': 'University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Dias', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}, {'ForeName': 'Adriana Coutinho', 'Initials': 'AC', 'LastName': 'de Azevedo Guimarães', 'Affiliation': 'Santa Catarina State University, Florianópolis, Brazil.'}]",Trials,['10.1186/s13063-019-3874-6']
542,31918760,A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial.,"BACKGROUND


Asylum seekers and refugees are at great risk for developing mental disorders. Afghan refugees are a particularly vulnerable group with a low average education and mental health literacy level. Traumatic experiences and hardship before and during migration are predictive of mental health problems. However, post-migration living difficulties (PMLDs) also account for a large proportion of mental distress in such populations, which, critically, are not sufficiently considered in treatment protocols and research investigations. Indeed, the evidence base for the treatment of refugees and asylum seekers is sparse and limited mainly to trauma-specific treatments, where refugees may likely suffer from other mental health problems such as depression or anxiety.
METHODS/DESIGN


This trial is the first evaluation of a short-term, transdiagnostic treatment protocol for treatment-seeking Afghan refugees which addresses mental health problems and PMLDs while using an adapted version of the Problem Management Plus (PM+) protocol. Here, we will investigate the efficacy of an intervention manual with a prospective, single-center, randomized, assessor-blind, two-group trial among refugees who are on a waiting list for professional mental health treatment. Furthermore, we will investigate participants' subjective experiences with the intervention manual via in-depth interviews. One hundred twenty people will be assessed and randomly allocated to either the intervention arm or a treatment-as-usual arm. Clinical psychologists will conduct the treatment, and the sessions will take place with a Dari interpreter. The protocol consists of six 90-min sessions. The primary endpoint is the general symptom distress measure, assessed with the General Health Questionnaire 28 (GHQ-28). Secondary endpoints are the Post-Migration Living Difficulties Checklist (PMLDC), the International Trauma Questionnaire (ITQ), the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), the Psychological Outcome Profile (PSYCHLOPS), service and health care use (assessed with several items), and the Immigrant Integration Index (IPL-12).
DISCUSSION


This trial may provide substantial evidence for a brief transdiagnostic psychological intervention. Here, we intend to contribute to the treatment of mental health problems among Afghan refugees. The assessment of subjective experience with this treatment manual, as well as the evaluation of its clinical applicability, may optimize treatment acceptance and outcomes across a wide range of mental health problems among refugees.
TRIAL REGISTRATION


German Clinical Trials Register (DRKS) registration number: DRKS00016538. Universal Trial Number: U1111-1226-3285. Registered on January 7, 2019. https://www.drks.de/drks_web/setLocale_EN.do.",2020,"Secondary endpoints are the Post-Migration Living Difficulties Checklist (PMLDC), the International Trauma Questionnaire (ITQ), the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), the Psychological Outcome Profile (PSYCHLOPS), service and health care use (assessed with several items), and the Immigrant Integration Index (IPL-12).
","['One hundred twenty people', 'refugees who are on a waiting list for professional mental health treatment', 'Afghan asylum seekers and refugees in Austria', 'mental health problems among Afghan refugees', ""participants' subjective experiences with the intervention manual via in-depth interviews""]",['transdiagnostic psychological intervention'],"['general symptom distress measure, assessed with the General Health Questionnaire 28 (GHQ-28', 'Post-Migration Living Difficulties Checklist (PMLDC), the International Trauma Questionnaire (ITQ), the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), the Psychological Outcome Profile (PSYCHLOPS), service and health care use (assessed with several items), and the Immigrant Integration Index (IPL-12']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C1272267', 'cui_str': 'Asylum Seekers'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0159028', 'cui_str': 'General symptom (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",120.0,0.125992,"Secondary endpoints are the Post-Migration Living Difficulties Checklist (PMLDC), the International Trauma Questionnaire (ITQ), the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), the Psychological Outcome Profile (PSYCHLOPS), service and health care use (assessed with several items), and the Immigrant Integration Index (IPL-12).
","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Knefel', 'Affiliation': 'Department of Applied Psychology: Health, Development, Enhancement and Intervention, Faculty of Psychology, University of Vienna, Wächtergasse 1, Vienna, 1010, Austria. matthias.knefel@univie.ac.at.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Kantor', 'Affiliation': 'Department of Applied Psychology: Health, Development, Enhancement and Intervention, Faculty of Psychology, University of Vienna, Wächtergasse 1, Vienna, 1010, Austria.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nicholson', 'Affiliation': 'Department of Basic Psychological Research and Research Methods, Faculty of Psychology, University of Vienna, Liebiggasse 5, Vienna, 1010, Austria.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schiess-Jokanovic', 'Affiliation': 'Department of Applied Psychology: Health, Development, Enhancement and Intervention, Faculty of Psychology, University of Vienna, Wächtergasse 1, Vienna, 1010, Austria.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Weindl', 'Affiliation': 'Department of Applied Psychology: Health, Development, Enhancement and Intervention, Faculty of Psychology, University of Vienna, Wächtergasse 1, Vienna, 1010, Austria.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schäfer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Lueger-Schuster', 'Affiliation': 'Department of Applied Psychology: Health, Development, Enhancement and Intervention, Faculty of Psychology, University of Vienna, Wächtergasse 1, Vienna, 1010, Austria.'}]",Trials,['10.1186/s13063-019-3839-9']
543,31782864,Comparison of efficacy of diclofenac and tramadol in relieving pain in patients of acute pancreatitis: A randomized parallel group double blind active controlled pilot study.,"BACKGROUND


Opioids and non steroidal anti inflammatory drugs (NSAIDs) are commonly used for pain relief in acute pancreatitis (AP). Opioids carry risk of sphincter of oddi constriction. Although diclofenac prevents post endoscopic retrograde cholangio-pancreatography (ERCP) pancreatitis, few reports of diclofenac associated AP are also present. Although, both tramadol and diclofenac are commonly used for pain relief in AP, no study has evaluated their comparative efficacy and safety.
MATERIALS AND METHODS


Forty-six eligible participants were randomized to either diclofenac or tramadol. Primary objectives of our study were improvement in pain intensity on visual analogue scale (VAS pain score after 1 hr of drug administration) and number of patients requiring supplementary analgesia. The secondary objectives were total number of times of supplementary analgesia requirement, time to significant decrease (33%) in VAS pain score from baseline, number of painful days (VAS pain score >5), VAS pain score on 7th day, side effects, all cause death and complications of pancreatitis between the two groups.
RESULTS


Although 46 patients were randomized, the final analysis included 41 participants. Five patients were withdrawn from the study (intubation = 3, altered sensorium = 2). No significant difference was seen in terms of VAS score after 1 hr of drug administration, number of patients requiring supplementary analgesic and number of painful days. However, time taken to significant reduction of pain was lower in the diclofenac group (p = .028). Both the agents were comparable in terms of safety. Although complications were less in the diclofenac group, the difference was not statistically significant.
CONCLUSION


Both diclofenac and tramadol are equally effective in controlling pain in AP with similar safety profile.
SIGNIFICANCE


There are no studies that have compared the safety and efficacy of two commonly used analgesics for pain relief in patients with AP. We found that both diclofenac and tramadol are equally effective in decreasing the pain associated with AP. There is also no significant difference in the incidence of side effects between both the groups. Hence both diclofenac and tramadol can be used safely and effectively for pain control in AP.
TRIAL REGISTRATION


The trial was registered with clinical trials registry India (Number- CTRI/2018/05/014309).",2020,"However, time taken to significant reduction of pain was lower in the diclofenac group (p = .028).","['patients of acute pancreatitis', 'Although46 patients were randomized, the final analysis included 41 participants', '5 patients were withdrawn from the study (intubation\xa0=\xa03, altered sensorium\xa0=\xa02', '46 eligible participants']","['tramadol', 'diclofenac', 'diclofenac or tramadol', 'tramadol and diclofenac', 'diclofenac and tramadol']","['total number of times of supplementary analgesia requirement, time to significant decrease (33%) in VAS pain score from baseline, number of painful days (VAS pain score\xa0>\xa05), VAS pain score on 7th day, side effects, all cause death and complications of pancreatitis', 'pain', 'pain intensity (VAS pain score after 1\xa0hr of drug administration), number of patients requiring supplementary analgesia', 'relieving pain', 'VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449809', 'cui_str': 'Number of times (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",41.0,0.107577,"However, time taken to significant reduction of pain was lower in the diclofenac group (p = .028).","[{'ForeName': 'Nadipalli S', 'Initials': 'NS', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Muktesh', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Samra', 'Affiliation': 'Department of Anaesthesiology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Phulen', 'Initials': 'P', 'LastName': 'Sarma', 'Affiliation': 'Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jayanta', 'Initials': 'J', 'LastName': 'Samanta', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Saroj K', 'Initials': 'SK', 'LastName': 'Sinha', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Dhaka', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Thakur D', 'Initials': 'TD', 'LastName': 'Yadav', 'Affiliation': 'Department of Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Surgery, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Kochhar', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]","European journal of pain (London, England)",['10.1002/ejp.1515']
544,31917372,"Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support.","BACKGROUND


Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions.
OBJECTIVE


This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial.
METHODS


We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support.
RESULTS


Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation.
CONCLUSIONS


The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15058.",2020,"Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings.","['120 service user participants from 8 CMHSs and follow them for 12 months', 'Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received']",['crisis intervention'],"['feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric inpatient'}]","[{'cui': 'C0010332', 'cui_str': 'Crisis Intervention'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0009475', 'cui_str': 'Community Mental Health Services'}]",,0.248826,"Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gumley', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bradstreet', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ainsworth', 'Affiliation': 'Division of Informatics, Imaging, and Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Allan', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Beattie', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Bell', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Birchwood', 'Affiliation': 'Division of Mental Health and Wellbeing, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Castagnini', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Engel', 'Affiliation': 'Deakin University, Melbourne, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Reeva', 'Initials': 'R', 'LastName': 'Lederman', 'Affiliation': 'School of Computing and Information Systems, Melbourne School of Engineering, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Shon', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Machin', 'Affiliation': 'Division of Informatics, Imaging, and Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Matrunola', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McLeod', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMeekin', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reilly', 'Affiliation': 'Scottish Recovery Network, Glasgow, United Kingdom.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwannauer', 'Affiliation': 'School of Health and Social Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Swaran P', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Division of Mental Health and Wellbeing, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Scottish Recovery Network, Glasgow, United Kingdom.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Sundram', 'Affiliation': 'Monash University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thomson', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Whitehill', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wilson-Kay', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Yung', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farhall', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'Australian Catholic University, Melbourne, Australia.'}]",JMIR research protocols,['10.2196/15058']
545,31907074,"Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial.","BACKGROUND


People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR.
METHODS


We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation.
DISCUSSION


The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.",2020,"We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR.","['people with chronic obstructive pulmonary disease (COPD', '430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS', ""patients with COPD and co-morbid anxiety and/or depression ('TANDEM"", 'People with chronic obstructive pulmonary disease (COPD', 'usual care across the Midlands, London, the South East and Bristol, UK', 'patients with COPD', 'patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR']","['Pulmonary rehabilitation (PR', 'cognitive behavioural approach (CBA) intervention', 'psychological intervention']","['psychological morbidity', 'HADS anxiety and depression subscale scores', 'uptake and completion of PR and healthcare resource use']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression (disorder)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",430.0,0.101872,"We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR.","[{'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Sohanpal', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Pinnock', 'Affiliation': 'Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Steed', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Heslop Marshall', 'Affiliation': 'Newcastle upon Tyne NHS Hospitals Foundation Trust, Chest Clinic, New Victoria Wing RVI Hospital, Queen Victoria Road, Newcastle upon Tyne, NE1 4LP, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Roberts', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Respiratory Sciences, College of Life Sciences, NIHR Leicester Biomedical Research Centre - Respiratory, Glenfield Hospital, University of Leicester, Groby Road, Leicester, LE3 9QP, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Smuk', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saqi-Waseem', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Healey', 'Affiliation': ""King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick CTU, Warwick Medical School, Gibbet Hill Road, Coventry, CV4 7AL and University Hospitals of Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, Great Maze Pond, London, SE1 1UL, UK.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Warburton', 'Affiliation': ', London, UK.'}, {'ForeName': 'Stephanie J C', 'Initials': 'SJC', 'LastName': 'Taylor', 'Affiliation': 'Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. s.j.c.taylor@qmul.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3800-y']
546,31919695,Impact of Race and Ethnicity on Weight-Loss Outcomes in Pediatric Family-Based Obesity Treatment.,"INTRODUCTION


Minority children are disproportionately affected by obesity and little is known about how race/ethnicity impacts outcomes in pediatric weight-loss treatment. This study aimed to evaluate whether race/ethnicity affected weight-loss outcomes in a pediatric obesity intervention. Secondary aims included evaluating whether race/ethnicity was associated with energy intake, exercise, program adherence, acceptability, and attendance.
METHODS


One hundred fifty parent/child dyads (age 8-12 years, BMI% 85-99.9; 32% Hispanic, 24% Non-Hispanic, Non-White, 44% Non-Hispanic White) participated in a randomized control trial evaluating weight loss in family-based behavioral treatment with (FBT) or without child participation (i.e., Parent-Based Treatment, PBT). Assessments occurred at baseline, mid-treatment (month 3), post-treatment (month 6), and follow-up (months 12 and 24). Analyses included linear mixed effect models, linear models, and a negative binomial model.
RESULTS


Weight loss in Hispanic, Non-Hispanic White, and Non-Hispanic, Non-White children was not significantly different by race/ethnicity at months 6, 12, and 24 (p = 0.259) and was similar across both treatments (FBT = - 0.16 BMIz; PBT = - 0.21 BMIz; p = 0.61). There were no differences in energy intake, physical activity, acceptability ratings, or adherence to treatment (as measured by a post-treatment survey) (p's > 0.123). However, Hispanic families attended fewer treatment visits than Non-Hispanic White families (p = 0.017).
CONCLUSION


On average, children lost weight participating in our pediatric obesity treatment and there was no statistical difference in weight loss between groups. Future research evaluating whether culturally adapted treatments would be more effective for racial/ethnic minorities or whether the personalization inherent in family-based behavioral treatment may be sufficient is needed.",2020,"There were no differences in energy intake, physical activity, acceptability ratings, or adherence to treatment (as measured by a post-treatment survey) (p's > 0.123).","['pediatric obesity intervention', 'Weight loss in Hispanic, Non-Hispanic White, and Non-Hispanic, Non', 'One hundred fifty parent/child dyads (age 8-12\xa0years, BMI% 85-99.9; 32% Hispanic, 24% Non-Hispanic, Non-White, 44% Non-Hispanic White', 'Pediatric Family-Based Obesity Treatment']","['weight loss in family-based behavioral treatment with (FBT) or without child participation (i.e., Parent-Based Treatment, PBT']","['weight loss', 'energy intake, exercise, program adherence, acceptability, and attendance', 'energy intake, physical activity, acceptability ratings, or adherence to treatment']","[{'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517914', 'cui_str': '99.9 (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0408724,"There were no differences in energy intake, physical activity, acceptability ratings, or adherence to treatment (as measured by a post-treatment survey) (p's > 0.123).","[{'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA. deichen@ucsd.edu.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, CA, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00694-6']
547,31907032,Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder.,"BACKGROUND


Only 40-60% of patients with generalized anxiety disorder experience long-lasting improvement with gold standard psychosocial interventions. Identifying neurobehavioral factors that predict treatment success might provide specific targets for more individualized interventions, fostering more optimal outcomes and bringing us closer to the goal of ""personalized medicine."" Research suggests that reward and threat processing (approach/avoidance behavior) and cognitive control may be important for understanding anxiety and comorbid depressive disorders and may have relevance to treatment outcomes. This study was designed to determine whether approach-avoidance behaviors and associated neural responses moderate treatment response to exposure-based versus behavioral activation therapy for generalized anxiety disorder.
METHODS/DESIGN


We are conducting a randomized controlled trial involving two 10-week group-based interventions: exposure-based therapy or behavioral activation therapy. These interventions focus on specific and unique aspects of threat and reward processing, respectively. Prior to and after treatment, participants are interviewed and undergo behavioral, biomarker, and neuroimaging assessments, with a focus on approach and avoidance processing and decision-making. Primary analyses will use mixed models to examine whether hypothesized approach, avoidance, and conflict arbitration behaviors and associated neural responses at baseline moderate symptom change with treatment, as assessed using the Generalized Anxiety Disorder-7 item scale. Exploratory analyses will examine additional potential treatment moderators and use data reduction and machine learning methods.
DISCUSSION


This protocol provides a framework for how studies may be designed to move the field toward neuroscience-informed and personalized psychosocial treatments. The results of this trial will have implications for approach-avoidance processing in generalized anxiety disorder, relationships between levels of analysis (i.e., behavioral, neural), and predictors of behavioral therapy outcome.
TRIAL REGISTRATION


The study was retrospectively registered within 21 days of first participant enrollment in accordance with FDAAA 801 with ClinicalTrials.gov, NCT02807480. Registered on June 21, 2016, before results.",2020,"This study was designed to determine whether approach-avoidance behaviors and associated neural responses moderate treatment response to exposure-based versus behavioral activation therapy for generalized anxiety disorder.
",['generalized anxiety disorder'],"['interventions: exposure-based therapy or behavioral activation therapy', 'behavioral activation and exposure-based therapy', 'exposure-based versus behavioral activation therapy', 'gold standard psychosocial interventions']","['Generalized Anxiety Disorder-7 item scale', 'hypothesized approach, avoidance, and conflict arbitration behaviors and associated neural responses']","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy (regime/therapy)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3874856', 'cui_str': 'Generalized anxiety disorder 7 item scale (assessment scale)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0085837', 'cui_str': 'Arbitrating'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0417238,"This study was designed to determine whether approach-avoidance behaviors and associated neural responses moderate treatment response to exposure-based versus behavioral activation therapy for generalized anxiety disorder.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Santiago', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Akeman', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kirlic', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Clausen', 'Affiliation': 'VA Mid-Atlantic Mental Illness Research, Education and Clinical Center, Durham, NC, USA.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Cosgrove', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'McDermott', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mathis', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paulus', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Psychology, Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abelson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Martell', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts-Amherst, Amherst, MA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wolitzky-Taylor', 'Affiliation': 'Psychology, Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA.'}, {'ForeName': 'W K', 'Initials': 'WK', 'LastName': 'Thompson', 'Affiliation': 'Family Medicine and Public Health, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Aupperle', 'Affiliation': 'Laureate Institute for Brain Research, 6655 South Yale Avenue, Tulsa, OK, 74136, USA. raupperle@laureateinstitute.org.'}]",Trials,['10.1186/s13063-019-3802-9']
548,31915045,"The effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery: a prospective, randomized, placebo-controlled trial.","INTRODUCTION


In current study we assessed the effect of transcutaneous electrical acupoint stimulation (TEAS) on the quality of early recovery in patients undergoing gynecological laparoscopic surgery.
METHODS


Sixty patients undergoing gynecological laparoscopic surgery were randomly assigned to TEAS (TEAS group) or control group (Con group). TEAS consisted of 30 min of stimulation (12-15 mA, 2/100 Hz) at the acupoints of Baihui (GV20), Yingtang (EX-HN-3), Zusanli (ST36) and Neiguan (PC6) before anesthesia. The patients in the Con group had the electrodes applied, but received no stimulation. Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1 (T0), postoperative day 1 (T1) and postoperative day 2 (T2); 100-mm visual analogue scale (VAS) scores at rest, mini-mental state examination (MMSE) scores, the incidence of nausea and vomiting, postoperative pain medications, and antiemetics were also recorded.
RESULTS


QoR-40 and MMSE scores of T0 showed no difference between two groups (QoR-40: 197.50 ± 2.57 vs. 195.83 ± 5.17), (MMSE: 26.83 ± 2.74 vs. 27.53 ± 2.88). Compared with the Con group, QoR-40 and MMSE scores of T1 and T2 were higher in the TEAS group (P < 0.05) (QoR-40: T1, 166.07 ± 8.44 vs. 175.33 ± 9.66; T2, 187.73 ± 5.47 vs. 191.40 ± 5.74), (MMSE: T1, 24.60 ± 2.35 vs. 26.10 ± 2.78; T2, 26.53 ± 2.94 vs. 27.83 ± 2.73). VAS scores of T1 and T2 were lower (P < 0.05) in the TEAS group (T1, 4.73 ± 1.53 vs. 3.70 ± 1.41; T2, 2.30 ± 0.95 vs. 1.83 ± 0.88); the incidence of postoperative nausea and vomiting (PONV), remedial antiemetics and remedial analgesia was lower in the TEAS group (P < 0.05) (PONV: 56.7% vs. 23.3%; incidence of remedial antiemetics: 53.3% vs. 23.3%; incidence of remedial analgesia: 80% vs. 43.3%).
CONCLUSION


The use of TEAS significantly promoted the quality of early recovery, improved MMSE scores and reduced the incidence of pain, nausea and vomiting in patients undergoing gynecological laparoscopic surgery.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02619578. Registered on 2 December 2015. Trial registry name: https://clinicaltrials.gov.",2020,"The use of TEAS significantly promoted the quality of early recovery, improved MMSE scores and reduced the incidence of pain, nausea and vomiting in patients undergoing gynecological laparoscopic surgery.
","['Sixty patients undergoing gynecological laparoscopic surgery', 'patients undergoing gynecological laparoscopic surgery']","['transcutaneous electrical acupoint stimulation (TEAS', 'MMSE', 'placebo', 'TEAS (TEAS group) or control group (Con group', 'TEAS']","['quality of early recovery, improved MMSE scores', 'incidence of postoperative nausea and vomiting (PONV), remedial antiemetics and remedial analgesia', 'VAS scores of T1 and T2', 'incidence of pain, nausea and vomiting', 'quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1 (T0), postoperative day 1 (T1) and postoperative day 2 (T2); 100-mm visual analogue scale (VAS) scores at rest, mini-mental state examination (MMSE) scores, the incidence of nausea and vomiting, postoperative pain medications, and antiemetics', 'QoR-40 and MMSE scores of T1 and T2', 'Quality of recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",60.0,0.374112,"The use of TEAS significantly promoted the quality of early recovery, improved MMSE scores and reduced the incidence of pain, nausea and vomiting in patients undergoing gynecological laparoscopic surgery.
","[{'ForeName': 'Xiangdi', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, Guizhou Provincial People's Hospital, No. 83 Zhongshan Road Nanming district, Guiyang City, Guizhou Province, China. Xiangdi_Yu@163.com.""}, {'ForeName': 'Fangxiang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Guizhou Provincial People's Hospital, No. 83 Zhongshan Road Nanming district, Guiyang City, Guizhou Province, China.""}, {'ForeName': 'Bingning', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Guizhou Provincial People's Hospital, No. 83 Zhongshan Road Nanming district, Guiyang City, Guizhou Province, China.""}]",Trials,['10.1186/s13063-019-3892-4']
549,31915039,"Community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India: protocol for a cluster-randomised controlled trial.","BACKGROUND


Improving the health and development of adolescents aged 10-19 years is a global health priority. One in five adolescents globally live in India. The Rashtriya Kishor Swasthya Karyakram (RKSK), India's national adolescent health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and girls. Groups aim to give adolescents a space to discuss the social and health issues affecting them and build their capacity to become active community members and leaders. There have been no evaluations of the community component of RKSK to date. In this protocol, we describe the evaluation of the Jharkhand Initiative for Adolescent Health (JIAH), a community intervention aligned with RKSK and designed to improve school attendance, dietary diversity and mental health among adolescent girls aged 10-19 years in rural Jharkhand, eastern India.
METHODS


The JIAH intervention is delivered by a community youth team consisting of yuva saathis (friends of youth), youth leadership facilitators and livelihood promoters. Teams conduct (a) peer-led Participatory Learning and Action meetings with girls and boys, mobilising adolescents, parents, health workers, teachers and the wider community to make changes for adolescent health and development; (b) group-based youth leadership activities to build adolescents' confidence and resilience; and (c) livelihood promotion with adolescents and their families to provide training and practical skills. We are evaluating the JIAH intervention through a parallel-group, two-arm, superiority, cluster-randomised controlled trial. The unit of randomisation is a geographic cluster of ~1000 people. A total of 38 clusters covering an estimated population of 40,676 have been randomised to control or intervention arms. Nineteen intervention clusters have adolescent groups, youth leadership activities and livelihood promotion. Nineteen control clusters receive livelihood promotion only. Study participants are adolescent girls aged 10-19 years, married or unmarried, in or out of school, living in the study area. Intervention activities are open to all adolescent boys and girls, regardless of their participation in surveys. We will collect data through baseline and endline surveys. Primary trial outcomes are school attendance, dietary diversity and internalising and externalising mental health problems. Secondary outcomes include access to school-related entitlements, emotional or physical violence, self-efficacy and resilience.
TRIAL REGISTRATION


ISRCTN17206016. Registered on 27 June 2018.",2020,"The Rashtriya Kishor Swasthya Karyakram (RKSK), India's national adolescent health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and girls.","['adolescent girls in rural eastern India', 'A total of 38 clusters covering an estimated population of 40,676', 'Community youth teams facilitating participatory adolescent groups, youth', 'Study participants are adolescent girls aged 10-19\u2009years, married or unmarried, in or out of school, living in the study area', 'adolescents aged 10-19\u2009years', 'adolescent girls aged 10-19 years in rural Jharkhand, eastern India']","[""Teams conduct (a) peer-led Participatory Learning and Action meetings with girls and boys, mobilising adolescents, parents, health workers, teachers and the wider community to make changes for adolescent health and development; (b) group-based youth leadership activities to build adolescents' confidence and resilience; and (c) livelihood promotion with adolescents and their families to provide training and practical skills"", 'leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health', 'livelihood promotion']","['school attendance, dietary diversity and mental health', 'access to school-related entitlements, emotional or physical violence, self-efficacy and resilience', 'school attendance, dietary diversity and internalising and externalising mental health problems']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0578718', 'cui_str': 'Mobilizes'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1456722', 'cui_str': 'Teen Health'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]",,0.0921124,"The Rashtriya Kishor Swasthya Karyakram (RKSK), India's national adolescent health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and girls.","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Rath', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Prost', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Subhashree', 'Initials': 'S', 'LastName': 'Samal', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Hemanta', 'Initials': 'H', 'LastName': 'Pradhan', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Sumitra', 'Initials': 'S', 'LastName': 'Gagrai', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Shibanand', 'Initials': 'S', 'LastName': 'Rath', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Raj Kumar', 'Initials': 'RK', 'LastName': 'Gope', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Prasanta', 'Initials': 'P', 'LastName': 'Tripathy', 'Affiliation': 'Ekjut, Chakradharpur, Jharkhand, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Rose-Clarke', 'Affiliation': ""Department of Global Health and Social Medicine, King's College London, Bush House NE Wing, London, WC2B 4BG, UK. kelly.rose-clarke@kcl.ac.uk.""}]",Trials,['10.1186/s13063-019-3984-1']
550,31466895,VR Simulation Leads to Enhanced Procedural Confidence for Surgical Trainees.,"OBJECTIVE


Active learning techniques result in greater knowledge acquisition compared to passive methods. For medical students with limited hands-on operative experiences, virtual reality platforms represent active learning and may enhance procedural training. We hypothesize that virtual reality simulators like Toolkit for Illustration of Procedures in Surgery (TIPS) are a more effective modality in teaching laparoscopic surgical techniques to medical students when compared to passive learning tools like videos.
DESIGN


In this crossover study, participants were randomly assigned to perform either a TIPS laparoscopic appendectomy followed by video of a laparoscopic cholecystectomy, or video of a laparoscopic appendectomy followed by TIPS laparoscopic cholecystectomy. A knowledge assessment followed each intervention. A postsurvey was used to gather feedback and subjective impressions of the learning experience.
SETTING


University of Central Florida College of Medicine.
PARTICIPANTS


Second, third, and fourth-year medical students (n = 37).
RESULTS


Validation of the content assessments revealed strong internal consistency (Cronbach's α = 0.73). A 2-tailed Fisher's exact test revealed that the video had greater ease of use (p = 0.032), but TIPS had greater utility as a learning tool (p < 0.001) and instilled greater confidence in the ability to reproduce procedural steps (p < 0.001). A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS both enhanced different aspects of student learning; however, the active TIPS platform produced greater confidence in the ability to reproduce the steps of the procedure and had greater utility as a learning strategy. Videos are simple to use and can serve a complementary role in curriculum design.",2020,"A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS","['Second, third, and fourth-year medical students (n = 37', 'University of Central Florida College of Medicine']","['TIPS laparoscopic appendectomy followed by video of a laparoscopic cholecystectomy, or video of a laparoscopic appendectomy followed by TIPS laparoscopic cholecystectomy', 'Video and TIPS']",[],"[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0339897', 'cui_str': 'TIPSS'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.0281266,"A 2-tailed t test of the average content quiz scores revealed no significant difference in percentage correct between groups on the laparoscopic appendectomy quiz (p = 0.772), but a difference favoring video learning on the laparoscopic cholecystectomy quiz (p = 0.042) CONCLUSIONS: Video and TIPS","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Lesch', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'University of Florida College of Engineering, Gainesville, Florida.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Cendán', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, Florida. Electronic address: juan.cendan@ucf.edu.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.08.008']
551,31586257,How a personalised transportable folding device for seating impacts dysphagia.,"PURPOSE


A personalised transportable folding device for seating (DATP) on a standard seat was developed by an occupational therapist at the Toulouse University Hospital Centre (patent no. WO 2011121249 A1) based on the hypothesis that the use of a seat to assist with better positioning on any chair during meals modifies the sitting posture and has an impact on cervical statics which increases the amplitude of movements of the axial skeleton (larynx and hyoid bone) and benefits swallowing. The aim of this work is to demonstrate that an improvement in sitting posture with the help of the DATP, through Hyoid bone motion, has an impact on the quality of swallowing in a dysphagic population which benefits from the device in comparison to a dysphagic population which does not benefit from the device after 1 month of care. The secondary endpoints concern the evaluation of the impact on other characteristics of swallowing, posture, the acceptability of the device and the quality of life.
METHODOLOGY


This is a randomised comparative clinical trial. The blind was not possible for the patients but the examiner who evaluated the outcome criterion was blinded to the group to which the patient belonged. The outcome criterion was the measurement of the hyoid bone movement during swallowing. The other criteria were collected during the videofluoroscopic examination of swallowing and by use of a questionnaire. Fifty-six (56) patients were included: 30 in the group without device (D-) and 26 in the group with the device (D+). All the patients benefited from a training course on seating. Only the D+ patients participated in this course where the use of the device was explained and the device was then kept for use at home for 1 month.
RESULTS


A significant improvement was noted in the postural criteria before and after use, in favour of a better posture for the two groups (p < 0.001) and more hyoid bone motion in the D+ group. The difference was significant in the bivariate analysis for horizontal movement (p = 0.04). After adjustment of potential factors of confusion, we noted a significant mean difference for the three distances in the D+ group in comparison to the D- group, of + 0.33 (95% CI [+ 0.17; + 0.48]) for horizontal movement, + 0.22 (95% CI [+ 0.03; + 0.40]) for vertical movement and + 0.37 (95% CI = [+ 0.20; + 0.53]) for horizontal movement. However, the other parameters, and notably the other swallowing markers were not significantly modified by the use of the device.
CONCLUSION


The personalised transportable folding device for seating developed to reduce dysphagia has an action on hyoid bone motion during swallowing. However, this positive effect on an intermediate outcome criterion of the quality of swallowing was not associated with an improvement in swallowing efficiency in the study population. The diversity of diseases with which the patients in this study were afflicted is a factor to be controlled in future studies with this device.",2020,"A significant improvement was noted in the postural criteria before and after use, in favour of a better posture for the two groups (p < 0.001) and more hyoid bone motion in the D+ group.","['Fifty-six (56) patients were included: 30 in the group without device (D-) and 26 in the group with the device (D', 'occupational therapist at the Toulouse University Hospital Centre (patent no']",['personalised transportable folding device for seating (DATP'],"['hyoid bone motion', 'hyoid bone movement during swallowing', 'characteristics of swallowing, posture, the acceptability of the device and the quality of life', 'postural criteria', 'quality of swallowing', 'swallowing efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030650', 'cui_str': 'Patent'}]","[{'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0045186', 'cui_str': 'dATP cpd'}]","[{'cui': 'C0020417', 'cui_str': 'Lingual Bone'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0034380'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0613057,"A significant improvement was noted in the postural criteria before and after use, in favour of a better posture for the two groups (p < 0.001) and more hyoid bone motion in the D+ group.","[{'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Woisard', 'Affiliation': 'Voice and Deglutition Unit, Otorhinolaryngology Department, Rangueil Larrey University Hospital of Toulouse, 31059, Toulouse Cedex, France. Woisard.v@chu-toulouse.fr.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Costes', 'Affiliation': 'Voice and Deglutition Unit, Otorhinolaryngology Department, Rangueil Larrey University Hospital of Toulouse, 31059, Toulouse Cedex, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Colineaux', 'Affiliation': 'Department of Epidemiology, USMR, 37 Allées Jules Guesde, 31073, Toulouse, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lepage', 'Affiliation': 'Department of Epidemiology, USMR, 37 Allées Jules Guesde, 31073, Toulouse, France.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05657-5']
552,31746542,1% Tetracaine hydrochloride injection pure solution aerosol inhalation combined with oral administration of dyclonine hydrochloride mucilage as upper airway anesthesia for bronchoscopy: A randomized controlled trial.,"BACKGROUND


During the bronchoscopy process, successful passage of the tracheoscope through the glottis can affect the following procedure of bronchoscopy. Therefore, safer, more effective and less painful anesthesia methods are particularly important for the bronchoscopy success rate.
OBJECTIVE


This study aimed to evaluate the efficacy of 1% tetracaine hydrochloride injection pure solution aerosol inhalation combined with oral administration of dyclonine hydrochloride mucilage during bronchoscopy.
METHODS


Patients who need bronchoscopy or bronchoscope treatment were randomly assigned to two groups; group A received pure tetracaine hydrochloride injection solution (3 mL of 1% tetracaine hydrochloride) aerosol inhalation combined with oral 5 mL of dyclonine hydrochloride mucilage and group B received diluted tetracaine hydrochloride injection (3 mL of 1% tetracaine hydrochloride injection + 3 mL of sterile water for injection) aerosol inhalation combined with oral 5 mL of dyclonine hydrochloride mucilage. The anesthetic effect and adverse reactions of these groups were observed and compared.
RESULT


A total of 523 patients were randomized. The results showed that patient's tolerance, cough response, glottis opening during the bronchoscope into the glottis and the time required to the tracheoscope pass through the glottis were obviously significantly better in group A than in group B. Vital signs including blood pressure, heart rate and pulse oxygen saturation were more stable in group A than in group B.
CONCLUSION


The 1% tetracaine hydrochloride injection pure liquid aerosol inhalation combined with oral administration of dyclonine hydrochloride mucilage as upper airway anesthesia is effective and safe for bronchoscopy. This method of local anesthesia is worthy of clinical application.",2020,"The results showed that patient's tolerance,cough response,glottis opening during the bronchoscope into the glottis and the time required to the tracheoscope pass through the glottis were obviously significantly better in group A than in group B.Vital signs including blood pressure, heart rate, and pulse oxygen saturation were more stable in group A than in group B.
CONCLUSION


","['bronchoscopy', '523 patients were randomized', 'Patients who need bronchoscopy or bronchoscope treatment']","['tetracaine hydrochloride', 'dyclonine hydrochloride mucilage', 'pure tetracaine hydrochloride injection solution (3ml of 1% tetracaine hydrochloride) aerosol inhalation combined with oral 5ml of dyclonine hydrochloride mucilage, and group B received diluted tetracaine hydrochloride injection (3ml of 1% tetracaine hydrochloride injection + 3ml of sterile water for injection) aerosol inhalation combined with oral 5ml of dyclonine hydrochloride mucilage', '1%Tetracaine hydrochloride']","['anesthetic effect and adverse reactions', ""patient's tolerance,cough response,glottis opening during the bronchoscope into the glottis and the time required to the tracheoscope pass through the glottis"", 'blood pressure, heart rate, and pulse oxygen saturation', 'effective and safe for bronchoscopy']","[{'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0304456', 'cui_str': 'Tetracaine hydrochloride'}, {'cui': 'C0304455', 'cui_str': 'Dyclonine hydrochloride'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}]","[{'cui': 'C3179301', 'cui_str': 'Anesthetic Effect'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0179432', 'cui_str': 'Bronchoscopes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]",523.0,0.0422774,"The results showed that patient's tolerance,cough response,glottis opening during the bronchoscope into the glottis and the time required to the tracheoscope pass through the glottis were obviously significantly better in group A than in group B.Vital signs including blood pressure, heart rate, and pulse oxygen saturation were more stable in group A than in group B.
CONCLUSION


","[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Faguang', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'ShaoKang', 'Initials': 'S', 'LastName': 'Dang', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'GuanPing', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ""Department of Respiratory and Critical Medicine, The Second Affiliated Hospital, Air Force Medical University, Xi'an, China.""}]",The clinical respiratory journal,['10.1111/crj.13110']
553,31906999,"Efficacy of switching to bilastine, a histamine H1 receptor antagonist, in patients with chronic spontaneous urticaria (H1-SWITCH): study protocol for a randomized controlled trial.","BACKGROUND


Chronic spontaneous urticaria (CSU) is characterized by the spontaneous appearance of wheals, angioedema, or both for > 6 weeks. Continuous treatment with H1-antihistamines is used as a first-line treatment for CSU. However, H1-antihistamine treatment leads to absence of symptoms in less than 50% of patients with CSU. Although Japanese guidelines for the diagnosis and treatment of urticaria recommend an increase in the H1-antihistamine dose or a switch to other H1-antihistamines, there is no evidence supporting a switch to other H1-antihistamines in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose.
METHODS


We will conduct a multicenter, open-label, non-inferiority, randomized, parallel, comparison study to determine if the efficacy of bilastine 20 mg is not inferior to that of a twofold H1-antihistamine dose increase in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose. This study will be performed at 15 academic hospitals in Japan, and the administration period (increasing the H1-antihistamine dose twofold vs. switching to bilastine 20 mg) will be 7 days. Participants (n = 150) will be randomized to either an increased H1-antihistamine dose or a switch to bilastine 20 mg at a 1:1 ratio. The primary endpoint, mean of the total symptom score of 5-7 days after the intervention, will be evaluated. The secondary objective is to determine if the safety of bilastine 20 mg regarding somnolence is superior to that of a twofold dose increase of H1-antihistamines. This will be measured by a change in the Japanese version of the Epworth Sleepiness Scale from baseline to 7 days after starting the intervention.
DISCUSSION


This multicenter, open-label, non-inferiority, randomized, parallel, comparison study will be, to our knowledge, the first well-designed clinical study to evaluate the efficacy of a switch to other H1-antihistamines in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed doses. This trial will provide evidence of the efficacy and safety of bilastine when treatment is switched in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose.
TRIAL REGISTRATION


Japan Registry of Clinical Trials (jRCT), jRCTs051180105. Registered on 8 March 2019.",2020,"Although Japanese guidelines for the diagnosis and treatment of urticaria recommend an increase in the H1-antihistamine dose or a switch to other H1-antihistamines, there is no evidence supporting a switch to other H1-antihistamines in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose.
","['patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose', 'Participants (n\u2009=\u2009150', 'patients with chronic spontaneous urticaria (H1-SWITCH', 'patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed doses', '15 academic hospitals in Japan', 'Chronic spontaneous urticaria (CSU']","['bilastine', 'histamine H1 receptor antagonist', 'increased H1-antihistamine dose or a switch to bilastine', 'H1-antihistamine']","['mean of the total symptom score', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C4521894', 'cui_str': 'Histamine H1 receptor antagonist (disposition)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0869922,"Although Japanese guidelines for the diagnosis and treatment of urticaria recommend an increase in the H1-antihistamine dose or a switch to other H1-antihistamines, there is no evidence supporting a switch to other H1-antihistamines in patients with refractory CSU who are unresponsive to H1-antihistamines at the licensed dose.
","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Fukunaga', 'Affiliation': 'Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan. atsushi@med.kobe-u.ac.jp.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Washio', 'Affiliation': 'Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Division of Biostatistics, Department of Social/Community Medicine and Health Science, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Kakei', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Institute of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Nishigori', 'Affiliation': 'Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.'}]",Trials,['10.1186/s13063-019-3878-2']
554,31907004,Pharmacological conditioning in the treatment of recent-onset rheumatoid arthritis: a randomized controlled trial study protocol.,"BACKGROUND


In pharmacological conditioning associations are formed between the effects of medication and contextual factors related to the medication. Pharmacological conditioning with placebo medication can result in comparable treatment effects and reduced side effects compared to regular treatment in various clinical populations, and may be applied to achieve enhanced drug effects. In the current study protocol, pharmacological conditioning is applied to achieve enhanced treatment effects in patients with recent-onset rheumatoid arthritis (RA). The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness for patients with inflammatory conditions, such as recent-onset RA.
METHODS


A multicenter, randomized controlled clinical trial is conducted in patients with recent-onset RA. Participants start on standardized pharmacological treatment for 16 weeks, which consists of methotrexate (MTX) 15 mg/week and a tapered schedule of prednisone 60 mg or 30 mg. After 4 months, participants in clinical remission (based on the rheumatologist's opinion and a targeted score below 1.6 on a 44-joint disease activity score (DAS44)) are randomized to 1 of 2 groups: (1) the control group (C), which continues with a standardized treatment schedule of MTX 15 mg/week or (2) the pharmacological conditioning group (PC), which receives an MTX treatment schedule in alternating high and low dosages. In the case of persistent clinical remission after 8 months, treatment is tapered and discontinued linearly in the C group and variably in the PC group. Both groups receive the same cumulative amount of MTX during each period. Logistic regression analysis is used to compare the proportion of participants with drug-free clinical remission after 12 months between the C group and the PC group. Secondary outcome measures include clinical functioning, laboratory assessments, and self-reported measures after each 4-month period up to 18 months after study start.
DISCUSSION


The results from this study broaden the knowledge on the potential of pharmacological conditioning and provide a potential innovative treatment option to optimize long-term pharmacological treatment effectiveness in patients with inflammatory conditions, such as recent-onset RA.
TRIAL REGISTRATION


Netherlands Trial Register, NL5652. Registered on 3 March 2016.",2020,"Pharmacological conditioning with placebo medication can result in comparable treatment effects and reduced side effects compared to regular treatment in various clinical populations, and may be applied to achieve enhanced drug effects.","['patients with recent-onset RA', 'patients with recent-onset rheumatoid arthritis (RA', 'patients with inflammatory conditions', 'recent-onset rheumatoid arthritis']","['prednisone 60\u2009mg or 30\u2009mg', 'MTX 15\u2009mg/week or (2) the pharmacological conditioning group (PC), which receives an MTX treatment schedule in alternating high and low dosages', 'methotrexate (MTX', 'MTX', 'Pharmacological conditioning', 'placebo medication']","['clinical remission', 'side effects', 'clinical functioning, laboratory assessments, and self-reported measures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0336702,"Pharmacological conditioning with placebo medication can result in comparable treatment effects and reduced side effects compared to regular treatment in various clinical populations, and may be applied to achieve enhanced drug effects.","[{'ForeName': 'Meriem', 'Initials': 'M', 'LastName': 'Manaï', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands. Manai@fsw.leidenuniv.nl.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands.'}, {'ForeName': 'Joy A', 'Initials': 'JA', 'LastName': 'van der Pol', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Tom W J', 'Initials': 'TWJ', 'LastName': 'Huizinga', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, P.O. Box 9555, 2300 RB, Leiden, The Netherlands.'}]",Trials,['10.1186/s13063-019-3777-6']
555,31907024,Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial).,"BACKGROUND


Alzheimer's disease (AD) is an epidemic with tremendous public health impacts because there are currently no disease-modifying therapeutics. Randomized controlled trials (RCTs) for prevention of AD dementia often use clinical endpoints that take years to manifest (e.g., cognition) or surrogate endpoints that are costly or invasive (e.g., magnetic resonance imaging [MRI]). Blood biomarkers represent a clinically applicable alternative surrogate endpoint for RCTs that would be both cost-effective and minimally invasive, but little is known about their value as surrogate endpoints for treatment responses in the prevention of AD dementia.
METHODS


The objective of this study is to investigate blood neuropathological, neurodegenerative, and neurotrophic biomarkers as surrogate endpoints for treatment responses to three interventions in older adults with amnestic mild cognitive impairment (aMCI, a prodromal stage of AD): aerobic exercise, cognitive training, and combined aerobic exercise and cognitive training (ACT). We chose these three sets of biomarkers for their unique mechanistic associations with AD pathology, neurodegeneration and neurogenesis. This study is built on the ACT Trial (1R01AG055469), a single-blinded, multi-site, 2 × 2 factorial phase II RCT that examines the synergistic effects of a 6-month ACT intervention on cognition and MRI biomarkers (AD-signature cortical thickness and hippocampal volume) (n = 128). In this ACT Trial blood biomarkers study, we will enroll 120 ACT Trial participants with aMCI and measure blood biomarkers at baseline and at 3, 6, 12, and 18 months. The goals are to (1) determine the effect of interventions on blood biomarkers over 6 months, (2) evaluate blood biomarkers as surrogate endpoints for predicting cognitive responses to interventions over 18 months, and (3, exploratory) examine blood biomarkers as surrogate endpoints for predicting brain MRI biomarker responses to interventions over 18 months.
DISCUSSION


This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training. Findings from this study will drive the further use of blood biomarkers in developing effective prevention and treatment strategies for AD dementia.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03313895. Registered on 18 October 2017.",2020,This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training.,"['enroll 120 ACT Trial participants with aMCI and measure blood biomarkers at baseline and at 3, 6, 12, and 18\u2009months', 'amnestic mild cognitive impairment', 'older adults with amnestic mild cognitive impairment (aMCI, a prodromal stage of AD', ""Alzheimer's disease (AD"", 'patients with aMCI subjected to a regimen of']","['aerobic exercise, cognitive training, and combined aerobic exercise and cognitive training (ACT', 'aerobic exercise and cognitive training (ACT', 'aerobic exercise and cognitive training', 'ACT intervention']","['cognition and MRI biomarkers (AD-signature cortical thickness and hippocampal volume', 'blood biomarkers']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3494361', 'cui_str': 'Prodromal Stage'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",120.0,0.163219,This study aims to identify new blood biomarkers that can track cognitive decline or AD-related brain atrophy among patients with aMCI subjected to a regimen of aerobic exercise and cognitive training.,"[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Lab Medicine and Pathology, University of Minnesota, 420 Delaware Street SE, MMC 609, Minneapolis, MN, 55455, USA. dannili@umn.edu.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Mielke', 'Affiliation': 'Department of Neurology and Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, 55902, USA.'}, {'ForeName': 'W Robert', 'Initials': 'WR', 'LastName': 'Bell', 'Affiliation': 'Department of Lab Medicine and Pathology, University of Minnesota, 420 Delaware Street SE, MMC 609, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Cavan', 'Initials': 'C', 'LastName': 'Reilly', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Feng Vankee', 'Initials': 'FV', 'LastName': 'Lin', 'Affiliation': 'University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY 14642, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, 5-140 WDH, 308 Harvard St SE, Minneapolis, MN, 55455, USA. yuxxx244@umn.edu.'}]",Trials,['10.1186/s13063-019-3798-1']
556,31846073,Volumetric facial contour changes of immediately placed implants with and without immediate provisionalization.,"BACKGROUND


Whether immediate provisionalization can preserve facial tissue contour remains undetermined. The goal of this 12-month randomized controlled clinical trial was to compare three-dimensional (3D) ridge changes after immediate implant placement with and without immediate provisionalization.
METHODS


Forty participants with an unrestorable maxillary anterior or premolar tooth were randomized to receive either a provisional crown (test) or standard healing abutment (control) after immediate implant placement. In each participant, three digital models taken before implant surgery, final crown delivery (4 months), and final follow-up (12 months) were registered to analyze linear deviation in 3D and volume changes of ridge contour at the implant site.
RESULTS


The mean value of mid-facial linear 3D spatial resorption ranged from 0.1 to 0.7 mm. Significant difference of linear changes of facial contour was noted over time and not between the groups. Facial volume changes at 12 months remained significantly higher in the control group than in the test group (17.4% versus 11.9%, P = 0.04).
CONCLUSIONS


Linear changes of facial soft-tissue resorption at immediately placed implants were independent of immediate provisionalization. However, immediate provisionalization showed better volume preservation at the esthetic concern area (mid-facial margin and 2 to 6 mm above) at the final 12-month follow-up.",2020,"Facial volume changes at 12 months remained significantly higher in the control group than in the test group (17.4 vs. 11.9%, P = 0.04).
",['Forty participants with an unrestorable maxillary anterior or premolar tooth'],['provisional crown (test) or standard healing abutment (control) after immediate implant placement'],"['3-dimensional (3D) ridge changes', 'linear changes of facial contour', 'mean value of mid-facial linear 3D spatial resorption', 'facial soft-tissue resorption', 'Volumetric facial contour changes', 'Facial volume changes']","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment (physical object)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",40.0,0.0601765,"Facial volume changes at 12 months remained significantly higher in the control group than in the test group (17.4 vs. 11.9%, P = 0.04).
","[{'ForeName': 'I-Ching', 'Initials': 'IC', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}, {'ForeName': 'Hsun-Liang', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kinney', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Department of Periodontics and Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI.'}]",Journal of periodontology,['10.1002/JPER.19-0308']
557,31831529,Furosemide versus mannitol in Japanese patients with thoracic malignancy who received cisplatin-based chemotherapy using short hydration: study protocol for a randomised controlled trial.,"INTRODUCTION


Cisplatin (CDDP) is a key drug for various thoracic malignancies. To avoid renal toxicity of CDDP, mannitol is routinely used, but it sometimes causes phlebitis which damages patients' quality of life. Furosemide is another widely used option for diuresis administered more quickly. To date, previous comparisons of these diuretics have lacked statistical significance owing to study design. We therefore undertake a randomised phase II comparative study of furosemide and mannitol in CDDP-based chemotherapy using short hydration.
METHODS AND ANALYSIS


This is a two-arm, prospective, randomised, single-centre, open-label phase II study. The primary endpoint is set as the proportion of patients who experienced any grade of 'creatinine increase' using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle. Secondary endpoints are: the proportion of patients who experienced ≥grade 2 of creatinine increase during the first cycle, any grade and ≥grade 2 of creatinine increase after the completion of fourth cycle, and the proportion of patients with phlebitis. Enrolled in this trial will be 105 patients.
ETHICS AND DISSEMINATION


This study was approved by the Wakayama Medical University Institutional Review Board on 30 March 2018 study (approval number: 2258). Patients have been enrolled since May 2018. As the study will complete accrual in March 2021, results will be published by 2021. This study will provide important information about the utility of furosemide compared with mannitol to protect against nephrotoxicity.
TRIAL REGISTRATION NUMBER


UMIN000031910.",2019,"The primary endpoint is set as the proportion of patients who experienced any grade of 'creatinine increase' using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle.","['105 patients', 'Wakayama Medical University Institutional Review Board on 30 March 2018 study (approval number: 2258', 'Japanese patients with thoracic malignancy who received']","['cisplatin-based chemotherapy', 'Furosemide versus mannitol', 'Furosemide', 'furosemide', 'furosemide and mannitol', 'CDDP, mannitol', 'Cisplatin (CDDP', 'mannitol']","['proportion of patients who experienced ≥grade 2 of creatinine increase during the first cycle, any grade and ≥grade 2 of creatinine increase', ""proportion of patients who experienced any grade of 'creatinine increase""]","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151578', 'cui_str': 'Creatinine increased'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0744121,"The primary endpoint is set as the proportion of patients who experienced any grade of 'creatinine increase' using the Common Terminology Criteria for Adverse Events V.4.0, during the first cycle.","[{'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Murakami', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan h-akamat@wakayama-med.ac.jp.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Nursing, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-029057']
558,31907022,Comparing how patients value and respond to information on risk given in three different forms during dental check-ups: the PREFER randomised controlled trial.,"BACKGROUND


This study aims to compare patient preference for, and subsequent change in, oral health behaviour for three forms of risk information given at dental check-ups (verbal advice compared to verbal advice accompanied by a traffic light (TL) risk card; or compared to verbal advice with a quantitative light fluorescence (QLF) photograph of the patient's mouth).
METHODS


A multi-centre, parallel-group, patient-randomised clinical trial was undertaken between August 2015 and September 2016. Computer-generated random numbers using block stratification allocated patients to three arms. The setting was four English NHS dental practices. Participants were 412 dentate adults at medium/high risk of poor oral health. Patients rated preference and willingness to pay (WTP) for the three types of information. The primary outcome was WTP. After receiving their check-up, patients received the type of information according to their group allocation. Follow-up was by telephone/e-mail at 6 and 12 months. Mean and median WTP for the three arms were compared using Wilcoxon signed-rank tests. Tobit regression models were used to investigate factors affecting WTP and preference for information type. Secondary outcomes included self-rated oral health and change in oral health behaviours (tooth-brushing, sugar consumption and smoking) and were investigated using multivariate generalised linear mixed models.
RESULTS


A total of 412 patients were randomised (138 to verbal, 134 to TL and 140 to QLF); 391 revisited their WTP scores after the check-up (23 withdrew). Follow-up data were obtained for 185 (46%) participants at 6 months and 153 (38%) participants at 12 months. Verbal advice was the first preference for 51% (209 participants), QLF for 35% (145 participants) and TL for 14% (58 participants). TL information was valued lower than either verbal or QLF information (p < 0.0001). Practice attended was predictive of verbal as first preference, and being older. Practice attended, preferring TL the most and having fewer than 20 teeth were associated with increased WTP; and living in a relatively deprived area or having low literacy decreased WTP. There were no significant differences in behaviour change on follow-up.
CONCLUSIONS


Although a new NHS dental contract based on TL risk stratification is being tested, patients prefer the usual verbal advice. There was also a practice effect which will needs to be considered for successful implementation of this government policy.
TRIAL REGISTRATION


ISRCTN, ISRCTN71242343. Retrospectively registered on 27 March 2018.",2020,TL information was valued lower than either verbal or QLF information (p < 0.0001).,"['Participants were 412 dentate adults at medium/high risk of poor oral health', 'A multi-centre', ""of the patient's mouth"", '412 patients were randomised (138 to verbal, 134 to TL and 140 to QLF); 391 revisited their WTP scores after the check-up (23 withdrew']",['dental check-ups (verbal advice compared to verbal advice accompanied by a traffic light (TL) risk card; or compared to verbal advice with a quantitative light fluorescence (QLF) photograph'],"['preference and willingness to pay (WTP', 'Mean and median WTP', 'self-rated oral health and change in oral health behaviours (tooth-brushing, sugar consumption and smoking', 'increased WTP', 'behaviour change', 'Verbal advice', 'TL information']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0029162'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0442664', 'cui_str': 'Traffic light (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0029162'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",209.0,0.194128,TL information was valued lower than either verbal or QLF information (p < 0.0001).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK. harrisrv@liverpool.ac.uk.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lowers', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Laverty', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vernazza', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle-upon-Tyne, Tyne and Wear, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle-upon-Tyne, Tyne and Wear, UK.'}]",Trials,['10.1186/s13063-019-3824-3']
559,31907002,Metta-based group meditation and individual cognitive behavioral therapy (MeCBT) for chronic depression: study protocol for a randomized controlled trial.,"BACKGROUND


Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing negative affect and have paid little attention to promoting positive affect. Previous studies have shown that metta meditation increases positive affect in chronically depressed patients. Results from previous trials provide evidence for the efficacy of a stand-alone metta meditation group treatment in combination with mindfulness-based approaches. Further research is needed to better understand the implementation of meditation practice into everyday life. Therefore, mindfulness and metta meditation in a group setting are combined with individual cognitive behavioral therapy (CBT) into a new, low-intensity, cost-effective treatment (""MeCBT"") for chronic depression.
METHODS/DESIGN


In this single-center, randomized, observer-blinded, parallel-group clinical trial we will test the efficacy of MeCBT in reducing depression compared to a wait-list control condition. Forty-eight participants in a balanced design will be allocated randomly to a treatment group or a wait-list control group. Metta-based group meditation will be offered in eight weekly sessions and one additional half-day retreat. Subsequent individual CBT will be conducted in eight fortnightly sessions. Outcome measures will be assessed at four time points: before intervention (T0); after group meditation (T1); after individual CBT (T2); and, in the treated group only, at 6-month follow-up (T3). Changes in depressive symptoms (clinician rating), assessed with the Quick Inventory of Depressive Symptoms (QIDS-C) are the primary outcome. We expect a significant decline of depressive symptoms at T2 compared to the wait-list control group. Secondary outcome measures include self-rated depression, mindfulness, benevolence, rumination, emotion regulation, social connectedness, social functioning, as well as behavioral and cognitive avoidance. We will explore changes at T1 and T2 in all these secondary outcome variables.
DISCUSSION


To our knowledge this is the first study to combine a group program focusing on Metta meditation with state-of-the art individual CBT specifically tailored to chronic depression. Implications for further refinement and examination of the treatment program are discussed.
TRIAL REGISTRATION


ISRCTN, ISRCTN97264476. Registered 29 March 2018 (applied on 14 December 2017)-retrospectively registered.",2020,"Changes in depressive symptoms (clinician rating), assessed with the Quick Inventory of Depressive Symptoms (QIDS-C) are the primary outcome.","['chronically depressed patients', 'chronic depression']","['individual cognitive behavioral therapy (CBT', 'wait-list control group', 'Metta-based group meditation and individual cognitive behavioral therapy (MeCBT', 'Metta-based group meditation', 'MeCBT']","['self-rated depression, mindfulness, benevolence, rumination, emotion regulation, social connectedness, social functioning, as well as behavioral and cognitive avoidance', 'Quick Inventory of Depressive Symptoms (QIDS-C', 'depressive symptoms (clinician rating', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression (disorder)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150277'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0004978', 'cui_str': 'Benevolence'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",48.0,0.0644772,"Changes in depressive symptoms (clinician rating), assessed with the Quick Inventory of Depressive Symptoms (QIDS-C) are the primary outcome.","[{'ForeName': 'Artjom', 'Initials': 'A', 'LastName': 'Frick', 'Affiliation': 'Institute for Psychology - Department of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, 60486, Frankfurt am Main, Germany. frick@psych.uni-frankfurt.de.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Thinnes', 'Affiliation': 'Institute for Psychology - Department of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, 60486, Frankfurt am Main, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stangier', 'Affiliation': 'Institute for Psychology - Department of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42, 60486, Frankfurt am Main, Germany.'}]",Trials,['10.1186/s13063-019-3815-4']
560,31907009,Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725).,"BACKGROUND


According to WHO, medication error (ME) is a subject that requires attention at all levels of care to reduce severe and preventable damage related to medication use. Clinical pharmacy practice standards have been proposed around the world so that the pharmacist, as part of a multidisciplinary health team, can help improve patient safety; however, further evidence derived from adequate studies is needed to demonstrate this. This study aims to assess the effect of a clinical pharmacy practice model (CPPM) in preventing MEs associated with the medication use process.
METHODS


A prospective, stepped-wedge, cluster-randomized, controlled trial with a duration of 14 months will be performed to compare the effect of a CPPM along with the usual care process of patients in the Pablo Tobón Uribe Hospital (Medellin, Colombia). The study is designed as a cluster-randomized controlled trial, involving five hospital wards (clusters) and 720 patients. Medical wards are allocated to interventions using a stepped-wedge design. Clusters are initially assigned to the control group. After a 2-month observation period, hospital clusters were randomly allocated to the intervention group. Study outcomes will be assessed at baseline and at 2, 4, 6, 8, 10, and 12 months after randomization. The primary outcome will be to assess the effect of a CPPM on the incidence of medication errors associated with the medication use process. Drug-related problems and factors that contribute to the occurrence of MEs will be assessed as secondary outcomes. Statistical analyses will be performed using a mixed model, with the treatment group and time as fixed effects and the clustering structure as a random effect. Statistical analysis will be performed using Pearson chi-square tests and Student's t-tests, and a P value < 0.05 will be considered statistically significant.
DISCUSSION


As far as we know, this is the first stepped-wedge, cluster-randomized, controlled trial designed to assess the change of a CPPM on the incidence of medication errors in a hospital in Colombia, and it could generate valuable information about a standardized and patient-centered clinical pharmacy model to improve the safety of inpatient care.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03338725. Registered on 9 November 2017. The first patient was randomized on 2 February 2018.
PROTOCOL VERSION


0010112018JG.",2020,The primary outcome will be to assess the effect of a CPPM on the incidence of medication errors associated with the medication use process.,"['five hospital wards (clusters) and 720 patients', 'patients in the Pablo Tobón Uribe Hospital (Medellin, Colombia']","['clinical pharmacy practice model (CPPM', 'CPPM']",['incidence of medication errors'],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087540', 'cui_str': 'Medication errors (SMQ)'}]",720.0,0.14107,The primary outcome will be to assess the effect of a CPPM on the incidence of medication errors associated with the medication use process.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granados', 'Affiliation': 'Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No 52-21, Medellín, Colombia. elkyn.granados@udea.edu.co.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salazar-Ospina', 'Affiliation': 'Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No 52-21, Medellín, Colombia.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Botero-Aguirre', 'Affiliation': 'Grupo Investigación clínica HPTU., Hospital Pablo Tobón Uribe, Calle 78B #69-240, Medellín, Antioquia, 05001000, Colombia.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Valencia-Quintero', 'Affiliation': 'Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No 52-21, Medellín, Colombia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ortiz', 'Affiliation': 'Grupo Investigación clínica HPTU., Hospital Pablo Tobón Uribe, Calle 78B #69-240, Medellín, Antioquia, 05001000, Colombia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Amariles', 'Affiliation': 'Grupo Promoción y Prevención Farmacéutica, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No 52-21, Medellín, Colombia.'}]",Trials,['10.1186/s13063-019-3945-8']
561,31852021,A self-help intervention for reducing time to diagnosis in Indonesian women with breast cancer symptoms.,"OBJECTIVE


We investigated the effectiveness of a self-help intervention named PERANTARA, which aims to improve adherence to diagnostic procedures among women with breast cancer (BC) symptoms to reduce the time to a definitive diagnosis.
METHODS


With a cluster randomized crossover design across four hospitals, PERANTARA and treatment as usual (TAU) or TAU only was provided at successive periods in a randomly determined order. The main outcome was the time between the first medical consultation and the definitive diagnosis. Secondary outcomes were BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L. A linear mixed model analysis was conducted to analyse the outcomes.
RESULTS


We recruited 132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group. PERANTARA reduced the time to definitive diagnosis by 13.3 days (M [SD]: 25.90 [23.20] in the intervention group vs 39.29 [35.10] in the control group; mean difference = -13.26, 95% CI = -24.51 to -2.00, P = .02). No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status.
CONCLUSIONS


PERANTARA reduced the time to definitive diagnosis among Indonesian women with BC symptoms. Psychoeducation may be an important addition to regular BC care to prevent undue delays in diagnostic procedures.",2020,"No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status.
","['132 women with BC symptoms from four hospitals; 67 participants were in the intervention group, and 65 participants were in the control group', 'women with breast cancer (BC) symptoms', 'Indonesian women with BC symptoms', 'Indonesian women with breast cancer symptoms']",[],"['time between the first medical consultation and the definitive diagnosis', 'BC knowledge, symptoms of anxiety, depression, quality of life, or health status', 'BC knowledge, measured by the Breast Cancer Knowledge Test (BCKT); symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS); quality of life, measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF); and health status, measured by the EQ-5D-5L', 'time to definitive diagnosis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",132.0,0.100029,"No significant difference was found between the groups in BC knowledge, symptoms of anxiety, depression, quality of life, or health status.
","[{'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Setyowibowo', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joke A M', 'Initials': 'JAM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Aulia', 'Initials': 'A', 'LastName': 'Iskandarsyah', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Whisnu', 'Initials': 'W', 'LastName': 'Yudiana', 'Affiliation': 'Department of Experimental Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Passchier', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Sawitri S', 'Initials': 'SS', 'LastName': 'Sadarjoen', 'Affiliation': 'Department of Clinical Psychology, Faculty of Psychology, Universitas Padjadjaran, Jatinangor, Indonesia.'}, {'ForeName': 'Dharmayanti F', 'Initials': 'DF', 'LastName': 'Badudu', 'Affiliation': 'Department of Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.'}, {'ForeName': 'Drajat R', 'Initials': 'DR', 'LastName': 'Suardi', 'Affiliation': 'Department of Surgical Oncology, Hasan Sadikin Hospital, Bandung, Indonesia.'}, {'ForeName': ""Edith Van't"", 'Initials': 'EV', 'LastName': 'Hof', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sijbrandij', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5316']
562,31897933,Clinical impact of rapid ventricular pacing on the left atrial posterior wall isolation by a cryoballoon application: a randomized controlled trial.,"PURPOSE


Rapid ventricular pacing (RVP) was reported to improve the cooling effects of the cryoballoon (CB). The aim of this study was to investigate the safety and efficacy of RVP for left atrial posterior wall isolation (PWI) by the CB.
METHODS


One hundred consecutive patients (males 80, mean age 63 ± 10 years) with persistent atrial fibrillation underwent left atrial roof (LA-RB) and bottom block line (LA-BB) creation by CB to achieve PWI. Patients were randomized into two groups according to whether they underwent PWI with (RVP group, n = 50) or without RVP (control group, n = 50).
RESULTS


The nadir CB temperature (NCT) during the LA-RB and LA-BB creation was significantly lower in the RVP group than control group (LA-RB - 45.7 °C and - 43.9 °C, p < 0.001, and LA-BB - 42.4 °C and - 40.0 °C, p < 0.001). The success rate of the LA-RB creation was significantly higher in the RVP group than the control group (98% vs. 88%, p = 0.039), however, there were no significant differences regarding the LA-BB creation (66% vs. 52%, p = 0.15) and PWI (66% vs. 50%, p = 0.1) between the two groups. The PWI success rate did not differ whether CB freezing was prematurely terminated due to an excessive luminal esophageal temperature (LET) drop in the RVP group (65.8% vs. 66.7%, respectively, p = 0.96).
CONCLUSIONS


RVP significantly decreased the NCT during the CB application resulting in the significant improvement of success rate of the LA-RB. The advantage of RVP in terms of the accomplishing PWI was not affected even when the CB freezing was prematurely terminated due to an excessive LET drop.",2020,"The success rate of the LA-RB creation was significantly higher in the RVP group than the control group (98% vs. 88%, p = 0.039), however, there were no significant differences regarding the LA-BB creation (66% vs. 52%, p = 0.15) and PWI (66% vs. 50%, p = 0.1) between the two groups.","['One hundred consecutive patients (males 80, mean age 63 ± 10 years) with persistent atrial fibrillation underwent left atrial roof (LA-RB) and bottom block line (LA-BB) creation by CB to achieve PWI']","['PWI with (RVP group, n = 50) or without RVP (control group, n = 50', 'CB', 'rapid ventricular pacing', 'RVP', 'Rapid ventricular pacing (RVP']","['PWI', 'success rate of the LA-RB creation', 'LA-BB creation', 'PWI success rate', 'safety and efficacy', 'success rate', 'nadir CB temperature (NCT) during the LA-RB and LA-BB creation']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}]","[{'cui': 'C0441513', 'cui_str': 'Construction (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",100.0,0.0440192,"The success rate of the LA-RB creation was significantly higher in the RVP group than the control group (98% vs. 88%, p = 0.039), however, there were no significant differences regarding the LA-BB creation (66% vs. 52%, p = 0.15) and PWI (66% vs. 50%, p = 0.1) between the two groups.","[{'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, 3-12-1 Shinyamashita, Naka-ward, Yokohama, Kanagawa, 231-0801, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Okishige', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, 3-12-1 Shinyamashita, Naka-ward, Yokohama, Kanagawa, 231-0801, Japan. okishige@yo.rim.or.jp.'}, {'ForeName': 'Yasuteru', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, 3-12-1 Shinyamashita, Naka-ward, Yokohama, Kanagawa, 231-0801, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Shigeta', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, 3-12-1 Shinyamashita, Naka-ward, Yokohama, Kanagawa, 231-0801, Japan.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, 3-12-1 Shinyamashita, Naka-ward, Yokohama, Kanagawa, 231-0801, Japan.'}, {'ForeName': 'Tastuhiko', 'Initials': 'T', 'LastName': 'Hirao', 'Affiliation': 'Heart Center, Japan Red Cross Yokohama City Bay Hospital, 3-12-1 Shinyamashita, Naka-ward, Yokohama, Kanagawa, 231-0801, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Sasano', 'Affiliation': 'Heart Rhythm Center, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Heart Rhythm Center, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing,['10.1007/s10840-019-00641-9']
563,31856476,Comparison of posterior optic capture of intraocular lens without vitrectomy vs endocapsular implantation with anterior vitrectomy in congenital cataract surgery: A randomized prospective study.,"Purpose


To compare surgical outcome of two procedures in pediatric cataract surgery.
Methods


Prospective randomised interventional study. Consecutive patients with bilateral congenital cataract who were operated during January 2016 to October 2016 at a tertiary care referral institute were included. One eye of all patients underwent Intraocular lens (IOL) implantation with optic capture through a primary posterior continuous curvilinear capsulorhexis (PPC) without vitrectomy while in the other eye endocapsular IOL implantation was performed along with PPC and anterior vitrectomy. Intraoperative challenges and postoperative complications were noted.
Results


15/18 children who fulfilled the inclusion criteria were included for follow up analysis. Mean age at the time of surgery was 21 ± 14.7 months. At a mean follow up of 25.69 ± 1.06 months; all eyes in both groups maintained a clinically centred IOL with clear visual axis. One patient with endocapsular IOL implantation developed anterior capsular phimosis. The rate of fibrinous complications (IOL deposits and synechiae) were more in the eyes with IOL in the bag (6 eyes) vs eyes where posterior optic capture was done (1 eye); P = 0.039.
Conclusion


Posterior optic capture is a safer alternative to conventional pediatric cataract surgery in terms of inflammatory sequelae and lens epithelial cell proliferation. However the two methods work equally well in preventing visual axis obscuration over a long follow-up.",2020,The rate of fibrinous complications (IOL deposits and synechiae) were more in the eyes with IOL in the bag (6 eyes) vs eyes where posterior optic capture was done (1 eye);,"['Consecutive patients with bilateral congenital cataract who were operated during January 2016 to October 2016 at a tertiary care referral institute were included', 'pediatric cataract surgery', '15/18 children who fulfilled the inclusion criteria were included for follow up analysis', 'congenital cataract surgery']","['posterior optic capture of intraocular lens without vitrectomy vs endocapsular implantation with anterior vitrectomy', 'Intraocular lens (IOL) implantation with optic capture through a primary posterior continuous curvilinear capsulorhexis (PPC) without vitrectomy while in the other eye endocapsular IOL implantation was performed along with PPC and anterior vitrectomy', 'endocapsular IOL implantation']","['rate of fibrinous complications (IOL deposits and synechiae', 'Intraoperative challenges and postoperative complications', 'visual axis obscuration', 'anterior capsular phimosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0009691', 'cui_str': 'Congenital cataract (disorder)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0197786', 'cui_str': 'Anterior vitrectomy (procedure)'}, {'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0443215', 'cui_str': 'Fibrinous (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C1096212', 'cui_str': 'Anterior capsular phimosis'}]",,0.0666875,The rate of fibrinous complications (IOL deposits and synechiae) were more in the eyes with IOL in the bag (6 eyes) vs eyes where posterior optic capture was done (1 eye);,"[{'ForeName': 'Savleen', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jaspreet', 'Initials': 'J', 'LastName': 'Sukhija', 'Affiliation': 'Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jagat', 'Initials': 'J', 'LastName': 'Ram', 'Affiliation': 'Advanced Eye Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_522_19']
564,31913413,Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial.,"Importance


Neoadjuvant systemic therapy (NST) is often administered to enable breast-conserving therapy (BCT) in stages II to III breast cancer.
Objectives


To prospectively evaluate the role of NST in conversion from BCT ineligibility to BCT eligibility and to assess the association of response to NST, germline BRCA (gBRCA) status, and region of treatment with surgical choice in women with triple-negative breast cancer (TNBC).
Design, Setting, and Participants


This prespecified secondary analysis of a multicentered, phase 3, double-blind, randomized clinical trial (BrighTNess) enrolled 634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia. Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate. Data were collected from April 1, 2014, to December 8, 2016. This preplanned analysis was performed from January 5, 2018, to October 28, 2019.
Interventions


Study participants were randomized to receive 12 weeks of weekly paclitaxel alone or with the addition of carboplatin and/or veliparib, followed by 4 cycles of doxorubicin hydrochloride and cyclophosphamide.
Main Outcomes and Measures


Surgeons assessed BCT candidacy by clinical and radiographic criteria before and after NST. Surgical choices and whether BCT eligibility was associated with the likelihood of pathologic complete response were then analyzed.
Results


Among the 634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients. Of 141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible. Overall, 342 (68.1%) of 502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible. Patients treated in Europe and Asia were more likely to undergo BCT (odds ratio, 2.66; 95% CI, 1.84-3.84) compared with those treated in North America. Among patients without gBRCA mutation undergoing mastectomy, those treated in North America were more likely to undergo contralateral prophylactic mastectomy (57 of 81 [70.4%] vs 6 of 30 [20.0%]; P < .001). Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
Conclusions and Relevance


This prospective analysis of NST and BCT eligibility in TNBC demonstrates a conversion from BCT ineligibility to BCT eligibility of 53.2%. Lower BCT rates among eligible patients and higher bilateral mastectomy rates among patients without gBRCA mutation in North America merit investigation.
Trial Registration


ClinicalTrials.gov identifier: NCT02032277.",2020,"Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
","['634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients', '141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible', '634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia', '502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible', 'Triple-Negative Breast Cancer', 'Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate', 'women with triple-negative breast cancer (TNBC']","['Neoadjuvant systemic therapy (NST', 'doxorubicin hydrochloride and cyclophosphamide', 'Neoadjuvant Chemotherapy', 'NST', 'paclitaxel alone or with the addition of carboplatin and/or veliparib']","['Lower BCT rates', 'BCT candidacy by clinical and radiographic criteria', 'bilateral mastectomy rates', 'contralateral prophylactic mastectomy', 'Rates of pathologic complete response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II (finding)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0546861', 'cui_str': 'Doxorubicin Hydrochloride'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0191877', 'cui_str': 'Bilateral mastectomy (procedure)'}, {'cui': 'C1705768'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",634.0,0.17405,"Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
","[{'ForeName': 'Mehra', 'Initials': 'M', 'LastName': 'Golshan', 'Affiliation': ""Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Medical Oncology, German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Jens Bodo', 'Initials': 'JB', 'LastName': 'Houber', 'Affiliation': 'Department of Medical Oncology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology-Baylor Sammons Cancer Center, US Oncology, Dallas.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medical Oncology, University of California, San Francisco.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'Department of Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Metzger-Filho', 'Affiliation': ""Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': 'Department of Medical Oncology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Department of Medical Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Department of Medical Oncology, Women and Infants Hospital of Rhode Island, Providence.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Breast Surgery, Helios Klinikum Berlin-Buch, Berlin, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2019.5410']
565,30081730,The role of cervical pessary and progesterone therapy in the phenomenon of placenta previa migration.,"Objective:  This study aimed to evaluate the effects of combined management of placenta previa with the Arabin cervical pessary and progesterone. Study design:  In this randomized controlled study, we followed up 217 patients with placenta previa and high risk of preterm birth. The main group ( n  = 81) underwent combined management with the Arabin cervical pessary and progesterone; the control group ( n  = 136) received progesterone only. Placental migration was monitored using Doppler scanning from 24 weeks of pregnancy onwards. Results:  Patients receiving the combination of the Arabin cervical pessary and progesterone had a three-fold reduced rate of bleeding during pregnancy compared with patients in the control group (11.3% versus 33.1%;  p  = .006). Placental migration occurred 1.8 times more often in the pessary group (48.1% versus 26.4%;  p  = .037), and preterm labor <34 weeks occurred 2.7 times less often compared with the control group ( p  = .031). The use of the Arabin cervical pessary caused a change in the anterior cervico-uterine angle by 7.4 degrees, and reduction in the arcuate artery RI at 32-33 weeks of pregnancy compared with the control group. Conclusions:  The use of the Arabin cervical pessary combined with progesterone in patients with placenta previa significantly reduced the rate of preterm delivery <34 weeks and bleeding during pregnancy.",2020,"Placental migration occurred 1.8 times more often in the pessary group (48.1% versus 26.4%; p = .037), and preterm labor <34 weeks occurred 2.7 times less often compared with the control group (p = .031).","['217 patients with placenta previa and high risk of preterm birth', 'patients with placenta previa']","['progesterone', 'combined management with the Arabin cervical pessary and progesterone', 'progesterone only', 'progesterone therapy']","['rate of bleeding during pregnancy', 'Placental migration', 'preterm labor', 'rate of preterm delivery <34 weeks and bleeding']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0031246', 'cui_str': 'Pessaries'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy (procedure)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",217.0,0.0495092,"Placental migration occurred 1.8 times more often in the pessary group (48.1% versus 26.4%; p = .037), and preterm labor <34 weeks occurred 2.7 times less often compared with the control group (p = .031).","[{'ForeName': 'Sergey V', 'Initials': 'SV', 'LastName': 'Barinov', 'Affiliation': 'Federal State Budget Educational Institution of Higher Education ""Omsk State Medical University"", Russian Ministry of Healthcare, Omsk, Russia.'}, {'ForeName': 'Inna V', 'Initials': 'IV', 'LastName': 'Shamina', 'Affiliation': 'Federal State Budget Educational Institution of Higher Education ""Omsk State Medical University"", Russian Ministry of Healthcare, Omsk, Russia.'}, {'ForeName': 'Gian Carlo', 'Initials': 'GC', 'LastName': 'Di Renzo', 'Affiliation': 'Department of Obstetrics and Gynecology and Centre for Perinatal and Reproductive Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Oksana V', 'Initials': 'OV', 'LastName': 'Lazareva', 'Affiliation': 'Federal State Budget Educational Institution of Higher Education ""Omsk State Medical University"", Russian Ministry of Healthcare, Omsk, Russia.'}, {'ForeName': 'Yuliya I', 'Initials': 'YI', 'LastName': 'Tirskaya', 'Affiliation': 'Federal State Budget Educational Institution of Higher Education ""Omsk State Medical University"", Russian Ministry of Healthcare, Omsk, Russia.'}, {'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Medjannikova', 'Affiliation': 'Federal State Budget Educational Institution of Higher Education ""Omsk State Medical University"", Russian Ministry of Healthcare, Omsk, Russia.'}, {'ForeName': 'Inna O', 'Initials': 'IO', 'LastName': 'Ledovskikh', 'Affiliation': 'Perinatal center, Budget Healthcare Omsk Region Institution ""Regional Clinical Hospital"", Omsk, Russia.'}, {'ForeName': 'Lyudmila L', 'Initials': 'LL', 'LastName': 'Klementyeva', 'Affiliation': 'OOO ""Alpha-EmBio"", Omsk, Russia.'}, {'ForeName': 'Galina V', 'Initials': 'GV', 'LastName': 'Dudkova', 'Affiliation': 'Perinatal center, Budget Healthcare Omsk Region Institution ""Regional Clinical Hospital"", Omsk, Russia.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2018.1509068']
566,31588910,Promoting Smoke-Free Homes Through Biomarker Feedback Documenting Child Exposure to Tobacco Toxins: Protocol for a Randomized Clinical Trial.,"BACKGROUND


Exposure to secondhand smoke (SHS) early in life increases the risk of sudden infant death syndrome (SIDS), asthma, and respiratory illnesses. Since children's primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a quickly reversible cause of excess morbidity, few low-income homes strictly enforce smoking restrictions.
OBJECTIVE


This study aims to test a novel approach to motivate the adoption of home smoking restrictions and to eliminate child SHS exposure by providing parents with objective data documenting home SHS exposure and ""biomarker feedback"" of child ingestion of tobacco toxins, that is, objective, laboratory-based results of assays performed on child urine, documenting levels of nicotine; cotinine; and NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), which is a metabolite of the known tobacco carcinogen NNK (4-[methylnitro-samino]-1-[3-pyridyl]-1-butanone).
METHODS


From 2011 to 2013, 195 low-income, female smokers with children aged ≤10 years residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97). In-home assessments were administered at baseline, week 16, and week 26. Children's home SHS exposure and nicotine, cotinine, and NNAL levels from urine samples, measured through a passive nicotine dosimeter and a surface sample of residual tobacco smoke (ie, thirdhand smoke), were collected at all three time points. Primary outcome was dosimeter-verified, self-reported complete home smoking restrictions at 6 months after randomization. Secondary outcomes included parental self-report of smoking behavior change and child urine tobacco toxin (biomarker) change.
RESULTS


Data collection and analyses are complete, and the results are being interpreted.
CONCLUSIONS


The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting home and child exposure to SHS on parental smoking behavior change.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/12654.",2019,Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97).,"['From 2011 to 2013', '195 low-income, female smokers with children aged ≤10 years residing in their homes']","['biomarker feedback documenting home and child exposure to SHS', 'biomarker feedback (n=98) and health education']","['parental smoking behavior change', ""Children's home SHS exposure and nicotine, cotinine, and NNAL levels"", 'dosimeter-verified, self-reported complete home smoking restrictions', 'parental self-report of smoking behavior change and child urine tobacco toxin (biomarker) change']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4082307', 'cui_str': 'Dosimeters'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042037'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}]",195.0,0.0588082,Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97).,"[{'ForeName': 'Janet Leigh', 'Initials': 'JL', 'LastName': 'Thomas', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, Division of General Internal Medicine, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Schreier', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, Division of General Internal Medicine, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'School of Public Health, Division of Biostatistics, Masonic Cancer Center, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Lowry', 'Affiliation': 'Clinical and Translational Sciences Institute, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hennrikus', 'Affiliation': 'Department of Epidemiology, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'An', 'Affiliation': 'Center for Health Communications Resarch, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'Center for Health Outcomes and Population Equity, Huntsman Cancer Center, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Brown University School of Public Health and Alpert School of Medicine, Providence, RI, United States.'}]",JMIR research protocols,['10.2196/12654']
567,31662331,TBCRC023: A Randomized Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab Without Chemotherapy for 12 versus 24 Weeks in Patients with HER2-Positive Breast Cancer.,"PURPOSE


Prior neoadjuvant trials with 12 weeks of dual anti-HER2 therapy without chemotherapy demonstrated a meaningful pathologic complete response (pCR) in patients with HER2-positive breast cancer. In this trial, we sought to determine whether longer treatment would increase the rate of pCR.
PATIENTS AND METHODS


TBCRC023 (NCT00999804) is a randomized phase II trial combining a Simon phase II design in the experimental arm with a pick-the-winner design, not powered for direct comparison. Women with HER2-positive breast tumors measuring ≥2 cm (median = 5 cm) were randomized in a 1:2 ratio to 12 versus 24 weeks of lapatinib and trastuzumab. Letrozole (along with ovarian suppression if premenopausal) was administered in patients whose tumors were also estrogen receptor (ER) positive. All evaluable patients were assessed for in-breast pCR.
RESULTS


Ninety-seven patients were enrolled (33 in 12-week arm and 64 in 24-week arm), of whom 94 were evaluable. Median age was 51 years, and 55% were postmenopausal. Median tumor size was 5 cm, and 65% were ER-positive. The rate of pCR in the 24-week arm was 28% and numerically superior to the 12-week arm (12%). This was driven by increased pCR in the ER-positive subgroup (33% vs. 9%). Study treatment was well tolerated, with grade 1-2 diarrhea and acneiform rash being the most common toxicities.
CONCLUSIONS


Treatment with dual anti-HER2 therapy for 24 weeks led to a numeric increase in pCR rate in women with HER2-positive breast cancer, without using chemotherapy. If validated, this approach may help identify patients who may benefit from deescalation of therapy.",2020,"CONCLUSIONS


Treatment with dual anti-HER2 therapy for 24 weeks led to a numeric increase in pCR rate in women with HER2-positive breast cancer, without using chemotherapy.","['Median age was 51 and 55% were postmenopausal', 'patients with HER2-positive breast cancer', 'Women with HER2-positive breast tumors measuring ≥2 cm (median=5 cm', 'Ninety-seven patients were enrolled (33 in 12-wk arm and 64 in 24-wk arm), of whom 94 were evaluable', 'Patients with HER2-positive Breast Cancer', 'women with HER2-positive breast cancer']","['Letrozole', 'dual anti-HER2 therapy without chemotherapy', 'dual anti-HER2 therapy', 'lapatinib and trastuzumab', 'Lapatinib Plus Trastuzumab', 'TBCRC023']","['rate of pCR', 'pCR rate', 'Median tumor size', 'meaningful pathologic complete response (pCR', 'tolerated with grade 1-2 diarrhea and acneiform rash']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1458155', 'cui_str': 'Breast Tumors'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",97.0,0.0822947,"CONCLUSIONS


Treatment with dual anti-HER2 therapy for 24 weeks led to a numeric increase in pCR rate in women with HER2-positive breast cancer, without using chemotherapy.","[{'ForeName': 'Mothaffar F', 'Initials': 'MF', 'LastName': 'Rimawi', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas. rimawi@bcm.edu.'}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Niravath', 'Affiliation': 'Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Brent N', 'Initials': 'BN', 'LastName': 'Rexer', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero', 'Affiliation': 'University of Alabama-Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Storniolo', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Nangia', 'Affiliation': 'Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Sao', 'Initials': 'S', 'LastName': 'Jiralerspong', 'Affiliation': 'Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pavlick', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Jamunarani', 'Initials': 'J', 'LastName': 'Veeraraghavan', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'De Angelis', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gutierrez', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schiff', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Hilsenbeck', 'Affiliation': 'Lester and Sue Smith Breast Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'C Kent', 'Initials': 'CK', 'LastName': 'Osborne', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0851']
568,31806605,Rituximab versus steroids and cyclophosphamide for the treatment of primary membranous nephropathy: protocol of a pilot randomised controlled trial.,"INTRODUCTION


Primary membranous nephropathy (MN) is a common cause of nephrotic syndrome in adults. The disease may have different long-term outcomes. After 10 years of follow-up, 35%-50% of the untreated patients with persistent nephrotic syndrome may die or progress to end stage renal disease. The 2012 KDIGO (Kidney Disease Improving Global Outcomes) guidelines recommend that initial therapy should consist of alternating steroids and an alkylating agent for 6 months. Recent observational studies showed that the anti-CD20 antibody rituximab may be effective in inducing remission. We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).
METHODS AND ANALYSIS


This pilot, open-label, two-parallel-arm, randomised clinical trial will enrol 70 patients with primary MN and heavy proteinuria. Patients will be randomised in a 1:1 ratio to either the intervention arm (rituximab) or the active comparator arm (corticosteroid/alkylating-agent therapy). The study will provide estimates of the probability of complete remission of proteinuria and risk of serious side effects at 12 months to inform the design of a larger trial. We will also assess the recruitment potential of each participating centre to address study feasibility.
ETHICS AND DISSEMINATION


The trial received ethics approval from the local ethics boards. We will publish pilot data to inform the design of a larger clinical trial.
TRIAL REGISTRATION NUMBERS


NCT03018535; 2011-006115-59.",2019,"We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).
","['patients with primary MN and heavy proteinuria (>3.5\u2009g/24\u2009hours', 'primary membranous nephropathy', '70 patients with primary MN and heavy proteinuria', 'nephrotic syndrome in adults']","['intervention arm (rituximab) or the active comparator arm (corticosteroid/alkylating-agent therapy', 'steroids and cyclophosphamide versus rituximab', 'Rituximab versus steroids and cyclophosphamide']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0017665', 'cui_str': 'Membranous Glomerulonephropathy'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0002073', 'cui_str': 'Alkylators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.196113,"We designed a pilot multicentre randomised trial to inform the design of a larger trial testing the efficacy and safety of treatment with steroids and cyclophosphamide versus rituximab in patients with primary MN and heavy proteinuria (>3.5 g/24 hours).
","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Scolari', 'Affiliation': 'Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Università di Brescia, Brescia, Italy ceccoscolari@gmail.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dallera', 'Affiliation': 'Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Università di Brescia, Brescia, Italy.'}, {'ForeName': 'Loreto', 'Initials': 'L', 'LastName': 'Gesualdo', 'Affiliation': 'Division of Nephroplogy, Universita degli Studi di Bari Aldo Moro, Bari, Puglia, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Division of Nephrology, Universita degli Studi di Messina, Messina, Sicilia, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Pani', 'Affiliation': 'Division of Nephrology, Ospedale Brotzu, Cagliari, Italy.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Santostefano', 'Affiliation': ""Division of Nephrology, Ospedale Sant'Orsola-Malpighi, Bologna, Italy.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Feriozzi', 'Affiliation': 'Division of Nephrology, Ospedale di Viterbo, Viterbo, Italy.'}, {'ForeName': 'Laila-Yasmin', 'Initials': 'LY', 'LastName': 'Mani', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital Universitatsspital Bern, Bern, Switzerland.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Boscutti', 'Affiliation': 'Nefrologia e Dialisi, Azienda Sanitaria Universitaria Integrata di Trieste, Trieste, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': 'Messa', 'Affiliation': 'Maggiore Hospital and IRCCS Foundation, Milano, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Magistroni', 'Affiliation': 'Universita degli Studi di Modena e Reggio Emilia Dipartimento di Scienze della Vita, Modena, Emilia-Romagna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Quaglia', 'Affiliation': 'Division of Nephrology, Universita degli Studi del Piemonte Orientale Amedeo Avogadro, Vercelli, Piemonte, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Ponticelli', 'Affiliation': 'Division of Nephrology, (past Director), Ospedale Maggiore Policlinico, Milano, Lombardia, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-029232']
569,31903866,Does exercise intensity affect wellness scores in a dose-like fashion?,"Wellness questionnaires are common in monitoring systems, yet the sensitivity to variations in acute training intensity is unclear. This study examined the controlled dosage effects of differing exercise intensities on wellness variables and subsequent associations with neuromuscular performance. Participants ( n  = 10) completed low-, moderate- and high-intensity conditions of a 90 min simulated football match shuttle running protocol scaled relative to beep test scores. The protocols were completed in a randomised and counterbalanced fashion matched for time of day. Wellness (sleep quality, readiness to train, soreness, fatigue, stress, mood, motivation) and neuromuscular performance (maximal voluntary contraction, countermovement jump, 6 s cycle-ergometer sprint) were assessed pre-, post- and 24 h post-exercise. Heart rate (HR) and rating of perceived exertion (RPE) were recorded during, and session RPE (sRPE) after exercise. Generalised linear mixed models demonstrated main effects between conditions with increased HR, RPE and sRPE ( P  < 0.03;  d  > 0.8) responses from the low-high condition. Total and z-score wellness showed no significant differences between trials at any time-point ( P  > 0.05;  d =  0.03-0.91). Fatigue was lower 24 h post-exercise for the low, compared to moderate and high conditions ( P  = 0.006-0.047;  d  = 1.20-1.77). Ratings of fatigue and soreness increased from pre- to 24 h post-trial ( P  < 0.003;  d  = 0.96-2.48), while total wellness and readiness to train decreased over time ( P  < 0.04;  d  = 0.91-1.86). Wellness showed limited capacity to differentiate training intensities. Practitioners should be aware while wellness may be highly practical, it may be limited to solely determine athlete accommodation of load considering the strength of association observed with the applied load.",2020,"Generalised linear mixed models demonstrated main effects between conditions with increased HR, RPE and sRPE ( P  <0.03;  d  >0.8) responses from the low-high condition.",['Participants (n=10) completed'],"['low-, moderate- and high-intensity conditions of a 90min simulated football match shuttle running protocol scaled relative to beep test scores']","['total wellness and readiness to train decreased over time', 'Wellness (sleep quality, readiness to train, soreness, fatigue, stress, mood, motivation) and neuromuscular performance (maximal voluntary contraction, countermovement jump, 6s cycle-ergometer sprint', 'HR, RPE and sRPE', 'Ratings of fatigue and soreness', 'Heart rate (HR) and rating of perceived exertion (RPE', 'Fatigue', 'Total and z-score wellness']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.0388702,"Generalised linear mixed models demonstrated main effects between conditions with increased HR, RPE and sRPE ( P  <0.03;  d  >0.8) responses from the low-high condition.","[{'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Campbell', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, Australia.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Stewart', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, Australia.'}, {'ForeName': 'Anita C', 'Initials': 'AC', 'LastName': 'Sirotic', 'Affiliation': 'Catapult Sports, Melbourne, Australia.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Minett', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, Australia.'}]",European journal of sport science,['10.1080/17461391.2019.1710264']
570,31691849,"Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial.","Three suitable compounds (morphine, chlorpromazine, and phenobarbital) to treat neonatal abstinence syndrome were compared in a prospective multicenter, double-blind trial. Neonates exposed to opioids in utero were randomly allocated to one of three treatment groups. When a predefined threshold of a modified Finnegan score was reached, treatment started and increased stepwise until symptoms were controlled. If symptoms could not be controlled with the predefined maximal dose of a single drug, a second drug was added. Among 143 infants recruited, 120 needed pharmacological treatment. Median length of treatment for morphine was 22 days (95% CI 18 to 33), for chlorpromazine 25 days (95% CI 21 to 34), and for phenobarbital 32 days (95% CI 27 to 38) (p = ns). In the morphine group, only 3% of infants (1/33) needed a second drug; in the chlorpromazine group, this proportion was 56% (24/43), and in the phenobarbital group 30% (13/44).Conclusion: None of the drugs tested for treating neonatal abstinence syndrome resulted in a significantly shorter treatment length than the others. As morphine alone was able to control symptoms in almost all infants, it may be preferred to the two other drugs but should still be tested against more potent opioids such as buprenorphine.Trial registration: At ClinicalTrials.gov NCT02810782 (registered retrospectively).What is Known:• Neonates exposed to opiates in utero and presenting with withdrawal symptoms should first be treated by non-pharmacological supportive measures.• In those who fail, drugs have to be given, but there is controversy which drug is best.What is New:• Among three candidates, morphine, chlorpromazine and phenobarbital, none resulted in significantly shorter treatment time.• As morphine alone was able to control symptoms in almost all infants, it may be preferred to the two other drugs.",2020,"Median length of treatment for morphine was 22 days (95% CI 18 to 33), for chlorpromazine 25 days (95% CI 21 to 34), and for phenobarbital 32 days (95% CI 27 to 38) (p = ns).","['143 infants recruited, 120 needed pharmacological treatment', 'neonatal abstinence syndrome', 'neonates with']","['morphine', 'morphine, phenobarbital, or chlorpromazine', 'morphine, chlorpromazine, and phenobarbital', 'chlorpromazine', 'buprenorphine', 'morphine, chlorpromazine']","['neonatal abstinence syndrome', 'Median length']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",143.0,0.264926,"Median length of treatment for morphine was 22 days (95% CI 18 to 33), for chlorpromazine 25 days (95% CI 21 to 34), and for phenobarbital 32 days (95% CI 27 to 38) (p = ns).","[{'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Neonatology, Spital Bülach, CH-8180, Bülach, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rudin', 'Affiliation': ""General Pediatrics, University Children's Hospital Basel, CH-4031, Basel, Switzerland.""}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Duò', 'Affiliation': 'Institute for Epidemiology, Biostatistics and Prevention, University of Zurich, CH-8001, Zurich, Switzerland.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Held', 'Affiliation': 'Institute for Epidemiology, Biostatistics and Prevention, University of Zurich, CH-8001, Zurich, Switzerland.'}, {'ForeName': 'Hans Ulrich', 'Initials': 'HU', 'LastName': 'Bucher', 'Affiliation': 'Department of Neonatology, University Hospital Zurich, CH - 8091, Zurich, Switzerland. buh@usz.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of pediatrics,['10.1007/s00431-019-03486-6']
571,31758835,"Efficacy of topical latanoprost in the treatment of eyelid vitiligo: A randomized, double-blind clinical trial study.","Numerous studies have demonstrated that the pigmentation of iris and around the eyelid is a common side effect of latanoprost, a prostaglandin F2alpha analogue used in the treatment of glaucoma. Hence, the authors decided to study the effectiveness of topical latanoprost on vitiligo patches around the eyelid. In this randomized, double-blind, clinical trial study, 31 patients with vitiligo vulgaris and focal vitiligo involving the eyelids were evaluated. Patients were randomly divided into two groups. First group received topical latanoprost gel twice daily for 12 weeks, whereas the second group received placebo with the same protocol. To evaluate severity of the disease the VIDA rating system was used. Serial photos of the patches were taken to compare and evaluate the repigmentation percentage of the patches. The patients in both groups had almost similar VIDA score (p > .05). First group showed improved pigmentation, whereas participants in the second group did not show any improvement in the pigmentation. The group treated with latanoprost showed significant reduction in the symptoms of the disease, whereas those treated with placebo did not show any alteration (p > .05). No significant complications were observed in either groups. Latanoprost proved effective in treating vitiligo disease involving eyelids.",2020,"No significant complications were observed in either groups.
","['eyelid vitiligo', '31 patients with vitiligo vulgaris and focal vitiligo involving the eyelids were evaluated']","['Latanoprost', 'latanoprost', 'topical latanoprost', 'placebo', 'topical latanoprost gel']","['pigmentation', 'VIDA score', 'symptoms of the disease']","[{'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0858681', 'cui_str': 'Vitiligo vulgaris'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C0090306', 'cui_str': 'latanoprost acid'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",31.0,0.0776528,"No significant complications were observed in either groups.
","[{'ForeName': 'Kiumars', 'Initials': 'K', 'LastName': 'Nowroozpoor Dailami', 'Affiliation': 'Department of Ophthalmology, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Faculty of Pharmacy, Mazandaran University of Medical Science, Sari, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Rahmatpour Rokni', 'Affiliation': 'Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Science, Sari, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Morteza-Semnani', 'Affiliation': 'Department of Medicinal Chemistry and Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sadeghi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed M', 'Initials': 'SM', 'LastName': 'Ghasemzadeh Diva', 'Affiliation': 'Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Goldust', 'Affiliation': 'Department of Dermatology, University of Rome G. Marconi, Rome, Italy.'}, {'ForeName': 'Torello', 'Initials': 'T', 'LastName': 'Lotti', 'Affiliation': 'Department of Dermatology, University of Studies Guglielmo Marconi, Rome, Italy.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Vojvodic', 'Affiliation': 'Department of Dermatology and Venereology, Military Medical Academy of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goren', 'Affiliation': 'Department of Dermatology, University of Studies Guglielmo Marconi, Rome, Italy.'}, {'ForeName': 'Sidharth', 'Initials': 'S', 'LastName': 'Sonthalia', 'Affiliation': 'Skinnocence: The Skin Clinic, Department of Dermatology & STD, Kalyani-Escorts Hospital, Gurgaon, India.'}, {'ForeName': 'Dipali', 'Initials': 'D', 'LastName': 'Rathod', 'Affiliation': 'Mumbai, India.'}]",Dermatologic therapy,['10.1111/dth.13175']
572,31899035,Incidence of Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study Report 40.,"PURPOSE


To report the natural history of untreated neovascular age-related macular degeneration (nAMD) regarding subsequent macular atrophy.
DESIGN


Prospective cohort within a randomized, controlled trial of oral micronutrient supplements.
PARTICIPANTS


Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy.
METHODS


Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD). Incident macular atrophy after nAMD was examined by Kaplan-Meier analysis and proportional hazards regression.
MAIN OUTCOME MEASURES


Incident macular atrophy after nAMD.
RESULTS


Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible. The cumulative risks of incident macular atrophy after untreated nAMD were 9.6% (standard error, 1.2%), 31.4% (standard error, 2.2%), 43.1% (standard error, 2.6%), and 61.5% (standard error, 4.3%) at 2, 5, 7, and 10 years, respectively. This corresponded to a linear risk of 6.5% per year. The cumulative risk of central involvement was 30.4% (standard error, 3.2%), 43.4% (standard error, 3.8%), and 57.0% (standard error, 4.8%) at first appearance of atrophy, 2 years, and 5 years, respectively. Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006). However, higher 52-single nucleotide polymorphism AMD genetic risk score was not associated with increased risk of macular atrophy (HR, 1.03; 95% CI, 0.90-1.17; P = 0.67). Similarly, no significant differences were observed according to SNPs at CFH, ARMS2, or C3.
CONCLUSIONS


The rate of incident macular atrophy after untreated nAMD is relatively high, increasing linearly over time and affecting half of eyes by 8 years. Hence, factors other than anti-VEGF therapy are involved in atrophy development, including natural progression to GA. Comparison with studies of treated nAMD suggests it may not be necessary to invoke a large effect of anti-VEGF therapy on inciting macular atrophy, although a contribution remains possible. Central involvement is present in one third of eyes at the outset (similar to pure GA) and increases linearly to half at 3 years.",2020,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","['Of the 4757 AREDS participants, 708 eyes (627 participants) demonstrated nAMD during follow-up and were eligible', 'Macular Atrophy after Untreated Neovascular Age-Related Macular Degeneration', 'Color fundus photographs were collected at annual study visits and graded centrally for late age-related macular degeneration (AMD', 'Age-Related Eye Disease Study (AREDS) participants (55-80 years) who demonstrated nAMD during follow-up (1992-2005), prior to anti-vascular endothelial growth factor (VEGF) therapy']",['oral micronutrient supplements'],"['risk of macular atrophy', 'cumulative risk of central involvement', 'higher 52-single nucleotide polymorphism AMD genetic risk score', 'cumulative risks of incident macular atrophy', 'SNPs at CFH, ARMS2, or C3', 'rate of incident macular atrophy', 'Geographic atrophy (GA']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1288283', 'cui_str': 'Anetoderma'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",627.0,0.0872275,"Geographic atrophy (GA) in the fellow eye was associated with increased risk of macular atrophy (hazard ratio [HR], 1.70; 95% confidence interval [CI], 1.17-2.49; P = 0.006).","[{'ForeName': 'Panos G', 'Initials': 'PG', 'LastName': 'Christakis', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Campbell', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Ferris', 'Affiliation': 'Ophthalmic Research Consultants, LLC, Waxhaw, North Carolina.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Tiarnan D', 'Initials': 'TD', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: tiarnan.keenan@nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.11.016']
573,31857298,"Opportunities for antibiotic optimisation and outcome improvement in patients with negative blood cultures: study protocol for a cluster-randomised crossover trial, the NO-BACT study.","INTRODUCTION


Patients with negative blood cultures (BCx) represent 85%-90% of all patients with BCx taken during hospital admission. This population usually includes a heterogeneous group of patients admitted with infectious diseases or febrile syndromes that require a blood culture. There is very little evidence of the clinical characteristics and antibiotic treatment given to these patients.
METHODS AND ANALYSIS


In a preliminary exploratory prospective cohort study of patients with BCx taken, the clinical/therapeutic characteristics and outcomes/antimicrobial stewardship opportunities of a population of patients with negative BCx will be analysed. In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.
ETHICS AND DISSEMINATION


This study has been and registered with clinicaltrials.gov. The findings of our study may support the implementation in clinical practice of an antimicrobial stewardship intervention to optimise the use of antibiotics in patients with negative BCx. The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03535324.",2019,"In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.
","['Patients with negative blood cultures (BCx) represent 85%-90% of all patients with BCx taken during hospital admission', 'patients with BCx taken, the clinical/therapeutic characteristics and outcomes/antimicrobial stewardship opportunities of a population of patients with negative BCx', 'patients with negative BCx', 'patients admitted with infectious diseases or febrile syndromes that require a blood culture', 'patients with negative blood cultures']",['antimicrobial stewardship intervention'],"['quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C0743841', 'cui_str': 'Febrile syndrome'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0898047,"In the second phase, using a cluster randomised crossover design, the implementation of an antimicrobial stewardship intervention targeting patients with negative BCx will be evaluated in terms of quality of antimicrobial use (duration and de-escalation), length of hospital stay and mortality.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Jiménez-Jorge', 'Affiliation': 'Clinical Research and Clinical Trials Unit, Hospital Universitario Virgen del Rocío, Seville, Spain silviajimenezjorge@gmail.com.'}, {'ForeName': 'Zaira R', 'Initials': 'ZR', 'LastName': 'Palacios-Baena', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Hospital Universitario Virgen Macarena. Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Rosso-Fernández', 'Affiliation': 'Clinical Research and Clinical Trials Unit, Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Girón-Ortega', 'Affiliation': 'Internal Medicine Department, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rodriguez-Baño', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Hospital Universitario Virgen Macarena. Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Retamar', 'Affiliation': 'Infectious Diseases and Clinical Microbiology Department, Hospital Universitario Virgen Macarena. Instituto de Biomedicina de Sevilla (IBIS), Hospital Universitario Virgen Macarena, Seville, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-030062']
574,31869474,"Effects of exercise training on serum preptin, undercarboxylated osteocalcin and high molecular weight adiponectin in adults with metabolic syndrome.","NEW FINDINGS


What is the central question of this study? Are the advantages of aerobic interval exercise, resistance exercise and concurrent exercise on the metabolic profile mediated in part through preptin and undercarboxylated osteocalcin (ucOCN)? What is the main finding and its importance? Glucose was significantly lowered after concurrent exercise and aerobic interval exercise, but serum preptin and insulin were significantly lowered in all three training groups. By contrast, ucOCN and high molecular weight adiponectin increased significantly in all three training groups. These findings support the possible cross-talk between bone, pancreatic β-cells and energy metabolism in humans and suggest that preptin and ucOCN may potentially serve as markers of exercise-induced improvement of metabolism.
ABSTRACT


Preptin is a peptide hormone that plays an important role in the development of obesity by regulation of carbohydrate metabolism. Undercarboxylated osteocalcin (ucOCN) is also linked to the regulation of body energy in that it modulates fat and glucose metabolism. This research aimed to examine the impact of aerobic interval, resistance and concurrent exercise on serum preptin, ucOCN and high molecular weight adiponectin (HMW-APN) in obese adults with metabolic syndrome (MetS). Forty-four obese men with MetS were randomized to receive aerobic interval exercise (AIEX, n = 10), resistance exercise (REX, n = 10), or concurrent aerobic interval and resistance exercise (CEX, n = 10), or to act as a non-exercise control (CON, n = 10) three times a week for 12 weeks. Preptin was reduced more after AIEX and CEX than after REX (89.1% and 87.1% versus 9.6%; P = 0.028 and 0.030, respectively). ucOCN increased significantly only in the CEX (27.5%, P = 0.009) and AIEX (25%, P = 0.025) groups, but HMW-APN increased significantly in all three training groups (AIEX 145.1%, P < 0.001; CEX 137%, P < 0.001; and REX 59.8%, P = 0.041). After the intervention, the improvement of peak oxygen uptake (    V   ̇   O   2   peak      ) in the AIEX group (73%) was greater than in the CEX (29.3%) and REX (3.8%) groups. On the other hand, CEX exhibited a greater reduction in glucose, insulin, insulin resistance index and HbA1c than did AIEX and REX. Our study indicates that the reduction in glucose after exercise training (especially AIEX and CEX) may be, somewhat, linked to decreased preptin and raised ucOCN and HMW-APN.",2020,"UcOCN increased significantly only in the CEX (27.5%, P = 0.009) and AIEX (25%, P = 0.025) groups.","['adults with metabolic syndrome', 'obese adults with metabolic syndrome (MetS', 'Forty-four obese men with MetS']","['aerobic interval (AIEX), resistance (REX) or concurrent exercise (CEX', 'CEX', 'exercise training', 'aerobic interval exercise (AIEX, n\xa0=\xa010), resistance exercise (REX, n\xa0=\xa010), or concurrent aerobic interval and resistance exercise (CEX, n\xa0=\xa010) or non-exercise control (CON', 'Undercarboxylated osteocalcin (ucOCN']","['serum preptin, ucOCN and high molecular weight-adiponectin (HMW-APN', 'serum preptin, undercarboxylated osteocalcin and high molecular weight-adiponectin', 'But HMW-APN', 'UcOCN', 'ucOCN and high molecular weight-adiponectin (HMW-APN', 'serum preptin, and insulin', 'Glucose', 'glucose, insulin, insulin resistance index and HbA1c than AIEX and REX', 'peak oxygen uptake (VO 2peak  ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0324505', 'cui_str': 'Rex'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1100366', 'cui_str': 'proinsulin-like growth factor II E-peptide (69-102)'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin (substance)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0324505', 'cui_str': 'Rex'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}]",44.0,0.0377689,"UcOCN increased significantly only in the CEX (27.5%, P = 0.009) and AIEX (25%, P = 0.025) groups.","[{'ForeName': 'Gholam Rasul', 'Initials': 'GR', 'LastName': 'Mohammad Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Bijeh', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}]",Experimental physiology,['10.1113/EP088036']
575,30623490,Prognostic implications of cytogenetics in adults with acute lymphoblastic leukemia treated with inotuzumab ozogamicin.,"Karyotype is frequently used to predict response and outcome in leukemia. This post hoc exploratory analysis evaluated the relationship between baseline cytogenetics and outcome in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) treated with inotuzumab ozogamicin (InO), a humanized CD22 antibody conjugated to calicheamicin, in the phase 3, open-label, randomized INO-VATE trial. Data as of March 8, 2016, are presented in this analysis. Of the 326 patients randomized, 284 had screening karyotyping data (144 in the InO arm and 140 in the standard care [SC] arm). With InO, complete remission or complete remission with incomplete hematologic recovery (CR/CRi), minimal residual disease negativity rates, and overall survival (OS) were not significantly different between cytogenetic subgroups. CR/CRi rates favored InO over SC in the diploid with ≥20 metaphases, complex, and ""other"" cytogenetic subgroups. The OS hazard ratio favored InO over SC in the diploid with ≥20 metaphases, complex, and other cytogenetic subgroups. Generally, InO is effective and provides substantial clinical benefit in patients with R/R ALL who have specific baseline karyotypes.",2019,"The OS hazard ratio favored InO over SC in the diploid with ≥20 metaphases, complex, and other cytogenetic subgroups.","['326 patients randomized, 284 had screening karyotyping data (144 in the InO arm and 140 in the standard care [SC] arm', 'patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) treated with', 'patients with R/R ALL who have specific baseline karyotypes', 'adults with acute lymphoblastic leukemia treated with inotuzumab ozogamicin']",['inotuzumab ozogamicin (InO'],"['complete remission or complete remission with incomplete hematologic recovery (CR/CRi), minimal residual disease negativity rates, and overall survival (OS', 'CR/CRi rates', 'OS hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0022526', 'cui_str': 'Karyotype Analysis Methods'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1261273', 'cui_str': 'Karyotype'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",326.0,0.0506191,"The OS hazard ratio favored InO over SC in the diploid with ≥20 metaphases, complex, and other cytogenetic subgroups.","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Anjali S', 'Initials': 'AS', 'LastName': 'Advani', 'Affiliation': 'Leukemia Program, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Department of Medicine A, Hematology and Oncology, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Department of Hematology/Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Liedtke', 'Affiliation': 'Divisions of Hematology and Oncology, Stanford Cancer Institute, Stanford, California.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Department of Medicine, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Institute Seràgnoli, DIMES, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Hematology/Oncology, Chao Family Comprehensive Cancer Center, University of California, Orange, California.'}, {'ForeName': 'Jane Liang', 'Initials': 'JL', 'LastName': 'White', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Luisa Paccagnella', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sleight', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeAngelo', 'Affiliation': 'Department of Medical Oncology/Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",American journal of hematology,['10.1002/ajh.25394']
576,31784410,Stepping Stones and Creating Futures Intervention to Prevent Intimate Partner Violence Among Young People: Cluster Randomized Controlled Trial.,"PURPOSE


Young people, not in formal employment or education, face exceedingly high levels of intimate partner violence (IPV). We evaluated whether Stepping Stones and Creating Futures, compared with a wait-list control, can reduce IPV and strengthen livelihoods.
METHODS


A cluster randomized controlled trial with 34 clusters in urban informal settlements in eThekwini Municipality, South Africa. Participant inclusion criteria were aged 18-30 years, resident in the informal settlement, and not working or in education. A total of 676 women and 646 men were recruited from September 2015 to September 2016. At recruitment, participants were not blinded to study arm. Endline data were collected from March to October 2018 (24 months postenrollment). Analyses were by intention-to-treat and separate for men and women. No clusters withdrew; endline retention was 74.9% (n = 505) men and 80.6% (n = 545) women.
RESULTS


At endline in the intervention arm, men's self-reported past year IPV perpetration was lower (physical IPV [adjusted odds ratio [aOR]: .71, 95% confidence interval [CI]: .51-.97], severe IPV [aOR: .70, 95% CI: .52-.94], and sexual IPV [aOR: .74, 95% CI: .54-1.03]). There was no difference in men's controlling behaviors (β = .06, 95% CI: -.51 to .63) or past month earnings (β = .21, 95% CI: -.42 to .83). For women, earnings were significantly higher in the intervention arm (β = .97, 95% CI: .43-1.51), but there were no differences for past year IPV experience (physical IPV [aOR: .92, 95% CI: .62-1.37]; sexual IPV [aOR: .90, 95% CI: .64-1.28], severe IPV [aOR: .93, 95% CI: .66-1.31]) or controlling behaviors (β = -.01, 95% CI: -.88 to .86).
CONCLUSION


Stepping Stones and Creating Futures is effective in reducing men's self-reported perpetration of IPV and strengthening women's livelihoods, but not women's experiences of IPV.
TRIAL REGISTRATION


NCT03022370. Registered January 13, 2017.",2020,"Stepping Stones and Creating Futures is effective in reducing men's self-reported perpetration of IPV and strengthening women's livelihoods, but not women's experiences of IPV.
","['Intimate Partner Violence', 'Young People', 'Young people, not in formal employment or education, face exceedingly high levels of intimate partner violence (IPV', '34 clusters in urban informal settlements in eThekwini Municipality, South Africa', 'Participant inclusion criteria were aged 18-30 years, resident in the informal settlement, and not working or in education', 'A total of 676 women and 646 men were recruited from September 2015 to September 2016']","['Stepping Stones and Creating Futures', 'Stepping Stones and Creating Futures Intervention']","['past year IPV experience (physical IPV [aOR: .92', 'sexual IPV', ""men's self-reported past year IPV perpetration"", 'sexual IPV [aOR', 'severe IPV', ""men's controlling behaviors (β""]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0600182'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1831579', 'cui_str': 'Controlling behavior'}]",676.0,0.299506,"Stepping Stones and Creating Futures is effective in reducing men's self-reported perpetration of IPV and strengthening women's livelihoods, but not women's experiences of IPV.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa. Electronic address: Andrew.gibbs@mrc.ac.za.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Washington', 'Affiliation': 'Project Empower, Durban, South Africa.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Abdelatif', 'Affiliation': 'Biostatistics Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'Esnat', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Yandisa', 'Initials': 'Y', 'LastName': 'Sikweyiya', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Smanga', 'Initials': 'S', 'LastName': 'Mkhwanazi', 'Affiliation': 'Project Empower, Durban, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Pretoria, South Africa; School of Public Health, University of Witwatersrand, Johannesburg, South Africa; Office of the Executive Scientist, South African Medical Research Council, Cape Town, South Africa.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.10.004']
577,29562853,Virtual Remediation Versus Methylphenidate to Improve Distractibility in Children With ADHD: A Controlled Randomized Clinical Trial Study.,"Objective:  Virtual environments have been used to assess children with ADHD but have never been tested as therapeutic tools. We tested a new virtual classroom cognitive remediation program to improve symptoms in children with ADHD.  Method:  In this randomized clinical trial, 51 children with ADHD (7-11 years) were assigned to a virtual cognitive remediation group, a methylphenidate group, or a psychotherapy group. All children were evaluated before and after therapy with an ADHD Rating Scale, a Continuous Performance Test (CPT), and a virtual classroom task.  Results:  After therapy by virtual remediation, children exhibited significantly higher numbers of correct hits on the virtual classroom and CPT. These improvements were equivalent to those observed with methylphenidate treatment.  Conclusion:  Our study demonstrates for the first time that a cognitive remediation program delivered in a virtual classroom reduces distractibility in children with ADHD and could replace methylphenidate treatment in specific cases.",2020,"After therapy by virtual remediation, children exhibited significantly higher numbers of correct hits on the virtual classroom and CPT.","['Children With ADHD', '51 children with ADHD (7-11 years', 'children with ADHD']","['Virtual Remediation Versus Methylphenidate', 'virtual cognitive remediation', 'psychotherapy group', 'methylphenidate', 'virtual classroom cognitive remediation program']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],51.0,0.0263178,"After therapy by virtual remediation, children exhibited significantly higher numbers of correct hits on the virtual classroom and CPT.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Bioulac', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}, {'ForeName': 'Jean-Arthur', 'Initials': 'JA', 'LastName': 'Micoulaud-Franchi', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Maire', 'Affiliation': 'University of Bordeaux, INSERM U1219, Bordeaux, France.'}, {'ForeName': 'Manuel P', 'Initials': 'MP', 'LastName': 'Bouvard', 'Affiliation': 'Pôle Universitaire Psychiatrie Enfants et Adolescents, Bordeaux, France.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sagaspe', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philip', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}]",Journal of attention disorders,['10.1177/1087054718759751']
578,31608822,Contextual influences on the perception of pregnant women who use drugs: Information about women's childhood trauma history reduces punitive attitudes.,"Punitive attitudes and consequences (e.g., incarceration) for prenatal illicit drug use persist in the United States despite evidence that these policies are ineffective and even harmful to women and children. For instance, the threat of these consequences can deter women from seeking healthcare, prenatal care, and drug treatment. Punitive responses may persist due to pejorative public perceptions of pregnant women who use illicit drugs. Although there is evidence that contextual information about prenatal drug use (e.g., drug type) can change such perceptions, other contextual influences are unknown. This experimental study tested whether receiving contextual information about a pregnant woman who uses drugs (specifically, her childhood trauma history) reduces punitive and increases supportive attitudes toward the woman. In a vignette-based 2( pregnancy status : pregnant/not pregnant) x 2( history of childhood trauma : interpersonal/non-interpersonal) between-subjects design, young adult university participants ( N  = 461) were randomly assigned to read a vignette about a woman who uses methamphetamine. Punitive attitudes were significantly reduced by information that the pregnant woman had a history of childhood trauma, especially interpersonal (versus non-interpersonal) trauma ( η p 2  = .115). Supportive attitudes were not impacted ( η p 2  = .005). Information about the pregnant woman's trauma history predicted less agreement with incarcerating her, only indirectly, through less punitive attitudes ( R 2  = .21). Reductions in punitive attitudes were on the order of 1.5-2 points on 5-point self-report scales and controlled for participant gender and political conservatism. Results have practical implications for interdisciplinary work aimed at unlocking greater support for policies that help pregnant women make safe, informed decisions with dignity and access to healthcare.",2020,Reductions in punitive attitudes were on the order of 1.5-2 points on 5-point self-report scales and controlled for participant gender and political conservatism.,"['In a vignette-based 2( pregnancy status : pregnant/not pregnant', 'pregnant women who use illicit drugs', 'N  =\xa0461', ""pregnant women who use drugs: Information about women's childhood trauma history reduces punitive attitudes"", 'pregnant woman who uses drugs (specifically, her childhood trauma history', 'young adult university participants ']",['methamphetamine'],"['Punitive attitudes', 'Supportive attitudes']","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086190', 'cui_str': 'Illicit Drugs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}]",461.0,0.0238934,Reductions in punitive attitudes were on the order of 1.5-2 points on 5-point self-report scales and controlled for participant gender and political conservatism.,"[{'ForeName': 'Brianna C', 'Initials': 'BC', 'LastName': 'Delker', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Van Scoyoc', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Noll', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, Oregon, USA.'}]",Journal of trauma & dissociation : the official journal of the International Society for the Study of Dissociation (ISSD),['10.1080/15299732.2019.1675221']
579,31883294,Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study.,"BACKGROUND


Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up.
OBJECTIVES


To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI).
METHODS


Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI.
RESULTS


123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm 2  in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057).
CONCLUSIONS


The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.",2020,This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03).,"['Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention', '123 patients in bivalirudin arm and 28 patients in the UFH arm were included', 'patients with ST-elevation myocardial infarction (STEMI', 'patients with ST-segment elevation myocardial infarction undergoing']","['bivalirudin infusion regimens in the MATRIX', 'bivalirudin', 'bivalirudin infusion versus unfractionated heparin (UFH) infusion', 'bivalirudin versus unfractionated heparin infusion', 'heparin']","['change in minimum flow area (ΔMinFA) defined as (stent area\u2009+\u2009incomplete stent apposition [ISA] area)\u2009-\u2009(intraluminal defect\u2009+\u2009tissue prolapsed area) between the index and staged PCI', 'tissue protrusion', 'Optical coherence tomography (OCT', 'percentage of OCT frames', 'Mean stent area, percentage of malapposed struts, and mean percent thrombotic area', 'residual stent strut thrombosis']","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1443259', 'cui_str': 'Incomplete stent apposition'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",123.0,0.116703,This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03).,"[{'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Adamo', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Cardio-Thoracic Department, Civil Hospitals, Brescia, Italy.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Soud', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Yacob', 'Affiliation': 'MedStar Washington Hospital Center, Washington, District of Columbia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Picchi', 'Affiliation': 'Cardiovascular and Neurologic Department, Misericordia Hospital, Grosseto, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Sardella', 'Affiliation': 'Department of Cardiology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Frigoli', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Limbruno', 'Affiliation': 'Cardiovascular and Neurologic Department, Misericordia Hospital, Grosseto, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rigattieri', 'Affiliation': ""Division of Cardiology, Sant'Andrea Hospital, Rome, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Boccuzzi', 'Affiliation': 'Department of Cardiology, San Giovanni Bosco Hospital, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zimarino', 'Affiliation': 'Institute of Cardiology ""G. d\'Annunzio"" University, Chieti, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Contarini', 'Affiliation': 'Interventional Cardiology Unit Umberto I Hospital, Syracuse, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Russo', 'Affiliation': 'Interventional Cardiology Unit, Cardio-thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': 'Division of Cardiology, Department of Cardiothoracic and Respiratory Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Andò', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Cardiology Unit, Ospedali Riuniti di Rivoli, Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Garducci', 'Affiliation': ""Unita' Operativa Complessa di Cardiologia ASST di Vimercate (MB), Vimercate, Italy.""}, {'ForeName': 'Cataldo', 'Initials': 'C', 'LastName': 'Palmieri', 'Affiliation': 'Fondazione Toscana G. Monasterio - Ospedale del Cuore G. Pasquinucci, Pisa/Massa, Massa, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Department of Cardiology, Interventional Cardiology, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': 'Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, University of Bern, Bern, Switzerland.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28661']
580,31857313,Comparison between electronic and paper versions of patient-reported outcome measures in subjects with chronic obstructive pulmonary disease: an observational study with a cross-over administration.,"OBJECTIVES


A wide range of electronic devices can be used for data collection of patient-reported outcome (PRO) measures in subjects with chronic obstructive pulmonary disease (COPD). Although comparisons between electronic and paper-based PRO measures have been undertaken in asthmatics, it is currently uncertain whether electronic questionnaires work equally as well as paper versions in elderly subjects with COPD. The aim of this study was to compare the responses to paper and electronic versions of the Evaluating Respiratory Symptoms in COPD (E-RS) and the COPD Assessment Test (CAT).
DESIGN


A randomised cross-over design was used to compare the responses to paper and electronic versions of the two tools. The interval between the two administrations was 1 week.
SETTING


Electronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail. It was intended that half of the patients completed the electronic versions of both questionnaires first, followed by the paper versions while the other half completed the paper versions first.
PARTICIPANTS


Eighty-one subjects with stable COPD were included.
RESULTS


The E-RS total scores (possible range 0-40) were 6.8±7.4 and 5.0±6.6 in the paper-based and electronic versions, respectively, and the CAT scores (possible range 0-40) were 10.0±7.4 and 8.6±7.8. In both questionnaires, higher scores indicate worse status. The relationship between electronic and paper versions showed significant reliability for both the E-RS total score and CAT score (intraclass correlation coefficient=0.82 and 0.89, respectively; both p<0.001). However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05).
CONCLUSIONS


In both cases, the two versions of the same questionnaire cannot be used interchangeably even though they have both been validated.",2019,"However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05).
","['Electronic versions were self-administered under supervision using a tablet computer at our outpatient clinic (secondary care hospital in Japan) while paper questionnaires completed at home were requested to be returned by mail', 'Eighty-one subjects with stable COPD were included', 'subjects with chronic obstructive pulmonary disease', 'subjects with chronic obstructive pulmonary disease (COPD', 'elderly subjects with COPD']",[],"['E-RS total and CAT scores', 'E-RS total scores', 'CAT scores', 'E-RS total score and CAT score (intraclass correlation', 'COPD Assessment Test (CAT']","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0337953', 'cui_str': 'Secondary care hospital (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}]",81.0,0.0313509,"However, both the E-RS total and CAT scores were significantly higher in the paper versions (p<0.05).
","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan koichi-nishimura@nifty.com.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Kusunose', 'Affiliation': 'Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sanda', 'Affiliation': 'Department of Respiratory Medicine, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan.'}, {'ForeName': 'Yousuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Hoshi Iryo-Sanki Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'National Hospital Organization, Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Oga', 'Affiliation': 'Department of Respiratory Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-032767']
581,31886683,Parenting in 2 worlds: Effects of a culturally grounded parenting intervention for urban American Indians on participant cultural engagement.,"BACKGROUND


Culturally appropriate, evidence-based prevention programs are seldom available to the growing majority of American Indians (AIs) who now live in cities. Parenting in 2 Worlds (P2W), a culturally grounded parenting intervention, was created to strengthen family functioning and reduce behavioral health risks in urban AI families from diverse tribal backgrounds.
OBJECTIVES


This study reports on the AI cultural engagement of the P2W participants as an outcome of the intervention.
METHOD


Data came from 575 parents of AI children (ages 10-17) in a randomized controlled trial in three Arizona cities. Parents were recruited through urban Indian centers and randomized to P2W or to an informational family health curriculum, Healthy Families in 2 Worlds (HF2W). Both P2W and HF2W consisted of 10 workshops delivered weekly by AI community facilitators. Pretests and posttests measured identification and engagement with traditional AI heritage, culture and practices. Tests of the efficacy of P2W versus HF2W used baseline adjusted regression models using FIML estimation to adjust for attrition, including random effects (site, facilitator), and controlling dosage. Moderated treatment effects by pretest levels of cultural engagement were tested with mean centered interactions.
RESULTS


Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification. Increases in cultural engagement were significantly larger for P2W participants who were relatively less culturally engaged at pretest.
CONCLUSIONS


Culturally adapted parenting interventions like P2W that effectively build on AI cultural heritage can also promote greater AI cultural identification and involvement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification.","['Data came from 575 parents of AI children (ages 10-17', 'urban AI families from diverse tribal backgrounds', 'urban American Indians on participant cultural engagement', 'Parents were recruited through urban Indian centers and randomized to P2W or to an informational family health curriculum, Healthy Families in 2 Worlds (HF2W']",['culturally grounded parenting intervention'],"['AI ethnic identity, AI spirituality, and positive mainstream cultural identification', 'cultural engagement', 'behavioral health risks']","[{'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0600220', 'cui_str': 'Family Health'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]",[],"[{'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2019.0,0.0349673,"Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification.","[{'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Kulis', 'Affiliation': 'Sanford School of Social and Family Dynamics.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tsethlikai', 'Affiliation': 'Sanford School of Social and Family Dynamics.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Harthun', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Hibbeler', 'Affiliation': 'Phoenix Indian Center.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}, {'ForeName': 'Nicholet', 'Initials': 'N', 'LastName': 'Deschine Parkhurst', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}]",Cultural diversity & ethnic minority psychology,['10.1037/cdp0000315']
582,31500849,Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.,"BACKGROUND


Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months.
METHODS


We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed.
FINDINGS


Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed.
INTERPRETATION


Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.
FUNDING


British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.",2019,"INTERPRETATION


Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.
","['Between Nov 6, 2013, and March 31, 2018, 5401 patients', 'University College London Hospitals/University College London', 'Patients (age >18 years) with suspected STEMI and who were eligible for PPCI', 'patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis', 'patients with STEMI undergoing PPCI', 'patients with acute myocardial infarction (CONDI-2/ERIC-PPCI', 'patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI']","['standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI', 'remote ischaemic conditioning']","['myocardial infarct size', 'cardiac death or hospitalisation for heart failure', 'incidence of cardiac death and hospitalisation for heart failure', 'Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure', 'clinical outcomes (cardiac death or hospitalisation for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",2569.0,0.207272,"INTERPRETATION


Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.
","[{'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK; National Institute of Health Research Biomedical Research Centre at University College London Hospitals, Research & Development, London, UK; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore; National Heart Research Institute Singapore, National Heart Centre, Singapore; Yong Loo Lin School of Medicine, National University Singapore, Singapore; Centro de Biotecnologia-FEMSA, Tecnologico de Monterrey, Monterrey, Mexico. Electronic address: d.hausenloy@ucl.ac.uk.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'Oxford Heart Centre, Oxford University Hospitals National Health Service Trust, Oxford, UK; Department of Cardiovascular Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ulla Kristine', 'Initials': 'UK', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Ramlall', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK; University Hospital Southampton National Health Service Foundation Trust, Southampton, UK.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'Department of Cardiology, University Hospitals of North Midlands, Royal Stoke University Hospital, Stoke-on-Trent, UK.'}, {'ForeName': 'Heerajnarain', 'Initials': 'H', 'LastName': 'Bulluck', 'Affiliation': 'Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Clayton', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dana', 'Affiliation': 'Portsmouth Hospitals National Health Service Trust, Portsmouth, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrom', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Jens Flensted', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Erika Frischknecht', 'Initials': 'EF', 'LastName': 'Christensen', 'Affiliation': 'Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Garcia-Ruiz', 'Affiliation': 'Instituto de Investigación Sanitaria del Principado de Asturias, Hospital Universitario de Cabueñes, Oviedo, Spain; Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Diana A', 'Initials': 'DA', 'LastName': 'Gorog', 'Affiliation': 'Department of Cardiology, Lister Hospital, East and North Hertfordshire National Health Service Trust, Stevenage, UK; National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hjort', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Houghton', 'Affiliation': 'Servicio de Atención Médica de Urgencia-Asturias, Oviedo, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibanez', 'Affiliation': 'Centro Nacional de Investigaciones Cardiovasculares, Madrid, Spain; Centro de Investigacion Biomedica En Red Cardiovascular, Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Freddy K', 'Initials': 'FK', 'LastName': 'Lippert', 'Affiliation': 'Prehospital Emergency Medical Services, Capital Region of Denmark, Denmark.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Lønborg', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Dejan', 'Initials': 'D', 'LastName': 'Milasinovic', 'Affiliation': 'Department of Cardiology, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'More', 'Affiliation': 'Lancashire Cardiac Centre, Blackpool Teaching Hospitals National Health Service Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Nicholas', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perkins', 'Affiliation': 'Clinical Trials Unit and Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Radovanovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Emergency Centre, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Roby D', 'Initials': 'RD', 'LastName': 'Rakhit', 'Affiliation': 'Royal Free Hospital London and Institute of Cardiovascular Science, University College London, London, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ravkilde', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Alisdair D', 'Initials': 'AD', 'LastName': 'Ryding', 'Affiliation': 'Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schmidt', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Ingunn Skogstad', 'Initials': 'IS', 'LastName': 'Riddervold', 'Affiliation': 'Prehospital Emergency Medical Services, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Henrik Toft', 'Initials': 'HT', 'LastName': 'Sørensen', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Stankovic', 'Affiliation': 'Cardiology Clinic, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Department for Diagnostic and Catheterization Laboratories, Clinical Centre of Serbia, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Madhusudhan', 'Initials': 'M', 'LastName': 'Varma', 'Affiliation': 'The Heart Centre, North Cumbria University Hospitals National Health Service Trust, Carlisle, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Webb', 'Affiliation': ""King's College Hospital, King's Health Partnership, London, UK.""}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; Leeds Teaching Hospitals National Health Service Trust, Leeds, UK.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Yellon', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'The Hatter Cardiovascular Institute, University College London, London, UK. Electronic address: haboet@rm.dk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32039-2']
583,31782828,A randomized trial of a distraction-type intervention to assist in managing dressing changes for children experienced burns.,"AIM


To evaluate the impact of the specially designed medical dressing screen during wound dressing changes for children aged 1-3 who experienced a burn on their hand or foot.
DESIGN


Randomized controlled trial.
METHODS


The study was performed, between January 2019 - April 2019, at a Burn Outpatient Ward. A total of 52 outpatient children who had suffered burns were included in the clinical trial. The burn area of these participants accounted for 1-5% of the total body surface area. The children were randomly divided into two equal-sized groups, each receiving a different treatment. In the medical screen group (N = 26), a medical screen was used for children during the dressing changes. In the control group (N = 26), the children received only regular dressing changes. Pain level of the children during dressing change was the primary outcome, the satisfaction of children's parents and wound therapist were used as second outcomes. The Bonferroni method was used to perform pairwise comparisons of repeatedly measured data at different measurement times in two groups.
RESULTS


The results showed that the medical screen group had better outcomes with respect to pain management during dressing changes; in addition, the satisfaction score of the wound therapist and children's parents presented also better outcomes compared with the control group.
CONCLUSION


This study demonstrated application of the medical screen for burns can relieve the pain of 1 - 3-year old children experienced a burn during dressing changes. In addition, the application of the medical screen also increased the satisfaction of the child's parents and wound therapist. Registration NO: 1,900,020,953.
IMPACT


Compared with conventional dressing methods, the medical screen can be used as a novel way to decrease the negative experience of burn patients ages 1-3 who require dressing changes.",2020,"The results showed that the medical screen group had better outcomes with respect to pain management during dressing changes, what's more, the satisfaction score of the wound therapist and children's parents presented also better outcomes compared with the control group.
","['between January 2019 and April 2019, at a Burn Outpatient Ward', 'children aged 1-3 who experienced a burn on their hand or foot', 'children experienced burns', '52 outpatient children who had suffered burns were included in the clinical trial']","['distraction-type intervention', 'medical dressing screen']","[""satisfaction of the child's parents and wound therapist"", ""satisfaction of children's parents and wound therapist"", 'satisfaction score of the wound therapist', 'Pain level', 'pain management']","[{'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",,0.0354726,"The results showed that the medical screen group had better outcomes with respect to pain management during dressing changes, what's more, the satisfaction score of the wound therapist and children's parents presented also better outcomes compared with the control group.
","[{'ForeName': 'Xiu-Hang', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Chang-Lei', 'Initials': 'CL', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jia-Ju', 'Initials': 'JJ', 'LastName': 'Ren', 'Affiliation': 'School of Nursing, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Wei-Wei', 'Initials': 'WW', 'LastName': 'Wu', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jia-Ao', 'Initials': 'JA', 'LastName': 'Yu', 'Affiliation': 'Department of Burn Surgery, The First Hospital of Jilin University, Changchun, China.'}]",Journal of advanced nursing,['10.1111/jan.14278']
584,31301748,"Assessment of a home-based standing frame programme in people with progressive multiple sclerosis (SUMS): a pragmatic, multi-centre, randomised, controlled trial and cost-effectiveness analysis.","BACKGROUND


People severely impaired with progressive multiple sclerosis spend much of their day sitting, with very few options to improve motor function. As a result, secondary physical and psychosocial complications can occur. Effective and feasible self-management strategies are needed to reduce sedentary behaviour and enhance motor function. In this study, we aimed to assess the clinical and cost effectiveness of a home-based, self-managed, standing frame programme.
METHODS


SUMS was a pragmatic, multicentre, randomised controlled superiority trial of people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK. The study had assessor-blinded outcome assessments with use of clinician-rated and patient-rated measures at baseline, 20 weeks, and 36 weeks. After baseline assessment, participants were randomised (1:1) by computer-generated assignment to either a standing frame programme plus usual care or usual care alone. The intervention consisted of two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls (15 min per call). Participants were asked to stand for 30 min, three times per week over 20 weeks, and encouraged to continue in the longer term, although no further physiotherapy support was provided. The primary clinical outcome was motor function measured by the Amended Motor Club Assessment (AMCA) score at week 36, analysed in the modified intention-to-treat population (excluding only patients who were deemed ineligible after randomisation, those who withdrew from the trial and were unwilling for their previously collected data to be used, or those who did not provide baseline and week 36 measurements). A 9-point AMCA score change was considered clinically meaningful a priori. Adverse events were collected through a daily preformatted patient diary throughout the 36 weeks and analysed in the modified intention-to-treat population. An economic assessment established the resources required to provide the standing frame programme, estimated intervention costs, and estimate cost effectiveness. This trial is registered with the International Standard Randomised Controlled Trials, number ISRCTN69614598.
FINDINGS


Between Sept 16, 2015, and April 28, 2017, 285 people with progressive multiple sclerosis were screened for eligibility, and 140 were randomly assigned to either the standing frame group (n=71) or the usual care group (n=69). Of these, 122 completed the primary outcome assessment (61 participants in both groups) for the modified intention-to-treat analysis. The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014). For adverse events collected through patient diaries, we observed a disparity between the two groups in the frequency of short-term musculoskeletal pain (486 [41%] of 1188 adverse events in the standing frame group vs 160 [22%] of 736 adverse events in the usual care group), which was potentially related to the intervention. The musculoskeletal pain lasted longer than 7 days in five participants (two in the standing frame group and three in the usual care group). No serious adverse events related to the study occurred. The standing frame group had a mean 0·018 (95% CI -0·014 to 0·051) additional quality-adjusted life-years (QALYs) compared with those of the usual care group, and the estimated incremental cost-per-QALY was approximately £14 700.
INTERPRETATION


The standing frame programme significantly increased motor function in people with severe progressive multiple sclerosis, although not to the degree that was considered a priori as clinically meaningful. The standing frame is one of the first physiotherapy interventions to be effective in this population. We suggest that the programme is feasible as a home-based, self-managed intervention that could be routinely implemented in clinical practice in the UK.
FUNDING


UK National Institute of Health Research.",2019,"The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014).","['285 people with progressive multiple sclerosis', 'Between Sept 16, 2015, and April 28, 2017', 'people with severe progressive multiple sclerosis', 'people with progressive multiple sclerosis (SUMS', 'people with progressive multiple sclerosis and severe mobility impairment, undertaken in eight centres from two regions in the UK']","['computer-generated assignment to either a standing frame programme plus usual care or usual care alone', 'home-based standing frame programme', 'usual care group', 'two home-based physiotherapy sessions (60 min each) to set up the standing frame programme, supported by six follow-up telephone calls']","['sedentary behaviour and enhance motor function', 'frequency of short-term musculoskeletal pain', 'musculoskeletal pain', 'AMCA score', 'Adverse events', 'motor function', 'motor function measured by the Amended Motor Club Assessment (AMCA) score']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",61.0,0.129963,"The use of the standing frame resulted in a significant increase in AMCA score compared with that for usual care alone, with a fully adjusted between-group difference in AMCA score at 36 weeks of 4·7 points (95% CI 1·9-7·5; p=0·0014).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK. Electronic address: jenny.freeman@plymouth.ac.uk.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK; Norwich MS Centre, Norwich, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jarrett', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK; Mardon Neurorehabilitation Centre, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Hawton', 'Affiliation': 'University of Exeter Medical School, Health Economics Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'NIHR Research Design Service, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dennett', 'Affiliation': 'Faculty of Health and Human Sciences, School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Plymouth, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajicek', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Medical Statistics Group, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK; Peninsula Clinical Trials Unit, Faculty of Medicine and Dentistry, University of Plymouth, Plymouth, UK.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30190-5']
585,27909178,No Differences in Health Outcomes After Routine Inquiry About Violence Victimization in Young Women: A Randomized Controlled Study in Swedish Youth Health Centers.,"Youth is a period in life when the risk of violence victimization is high and association between victimization and ill health is well established. Youth rarely reveal violence victimization to health professionals if not directly asked but favor health professionals asking about victimization. The study's primary aim was to examine health outcomes in young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up. Secondary aims were to examine to what extent routine inquiry altered the consultation and re-victimization rates during the study period. A randomized controlled intervention study was conducted at Swedish youth health centers. Participants assigned to the intervention group were asked structured questions about violence. Victimized participants received empowering strategies and were offered further counseling. Participants in the control group completed questionnaires about victimization after the visit. Both groups answered questions about sociodemographics and health, constructed from validated instruments. A questionnaire was administered to all participants 12 months after baseline. Of 1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up. Lifetime violence victimization was reported by 53% in the intervention group and 60% in the control group, ns. There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns. Of victimized young women in the intervention group, 14% wanted and received further counseling. Routine inquiry about violence victimization and empowering strategies were feasible within ordinary consultations at youth health centers but did not demonstrate improved health outcomes at 12-month follow-up compared with controls. Questions about violence led to a high degree of disclosure, and 14% of victimized young women in the intervention group received further counseling as a result.",2020,"There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns.","['Swedish youth health centers', '1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up', 'young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up', 'Swedish Youth Health Centers', 'Young Women']",[],"['Re-victimization rates', 'Lifetime violence victimization', 'Health Outcomes', 'health outcomes']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",1445.0,0.0458545,"There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Palm', 'Affiliation': 'Uppsala University, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Högberg', 'Affiliation': 'Uppsala University, Sweden.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Olofsson', 'Affiliation': 'Mid Sweden University, Sundsvall, Sweden.'}, {'ForeName': 'Alkistis', 'Initials': 'A', 'LastName': 'Skalkidou', 'Affiliation': 'Uppsala University, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Danielsson', 'Affiliation': 'Umeå University, Sweden.'}]",Journal of interpersonal violence,['10.1177/0886260516681878']
586,29986592,"Enrollment Strategies, Barriers to Participation, and Reach of a Workplace Intervention Targeting Sedentary Behavior.","PURPOSE


To review enrollment strategies, participation barriers, and program reach of a large, 2-year workplace intervention targeting sedentary behavior.
APPROACH


Cross-sectional, retrospective review.
SETTING


Twenty-four worksites balanced across academic, industry, and government sectors in Minneapolis/Saint Paul (Minnesota) and Phoenix (Arizona) regions.
PARTICIPANTS


Full-time (≥30+ h/wk), sedentary office workers.
METHODS


Reach was calculated as the proportion of eligible employees who enrolled in the intervention ([N enrolled/(proportion of eligible employees × N total employees)] × 100). Mean (1 standard deviation) and median worksite sizes were calculated at each enrollment step. Participation barriers and modifications were recorded by the research team. A survey was sent to a subset of nonparticipants (N = 57), and thematic analyses were conducted to examine reasons for nonparticipation, positive impacts, and negative experiences.
RESULTS


Employer reach was 65% (56 worksites invited to participate; 66% eligible of 56 responses; 24 enrolled). Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled). Postrandomization, on average, 59% (15%) of the worksites participated. Eighteen modifications were developed to overcome participant-, context-, and research-related participation barriers.
CONCLUSION


A high proportion of worksites and employees approached to participate in a sedentary behavior reduction intervention engaged in the study. Interventions that provide flexible enrollment, graded participant engagement options, and adopt a participant-centered approach may facilitate workplace intervention success.",2019,"Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled).","['Reach was calculated as the proportion of eligible employees who enrolled in the intervention ([N enrolled/(proportion of eligible employees × N total employees', 'Twenty-four worksites balanced across academic, industry, and government sectors in Minneapolis/Saint Paul (Minnesota) and Phoenix (Arizona) regions', 'Employer reach was 65% (56 worksites invited to participate; 66% eligible of 56 responses; 24 enrolled', 'Full-time (≥30+ h/wk), sedentary office workers', 'Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled']",[],['Mean (1 standard deviation) and median worksite sizes'],"[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",632.0,0.023983,"Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled).","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mullane', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Rydell', 'Affiliation': '2 Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Larouche', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Meynard John L', 'Initials': 'MJL', 'LastName': 'Toledo', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Feltes', 'Affiliation': '3 Minnesota Department of Health, Saint Paul, MN, USA.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Vuong', 'Affiliation': '4 Fairview Health Services, Saint Paul, MN, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': '5 Graduate School of Public Health, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Gaesser', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': '6 College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pereira', 'Affiliation': '2 Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118784228']
587,31300303,Clinical randomized trial study of hearing aids effectiveness in association with Ginkgo biloba extract (EGb 761) on tinnitus improvement.,"INTRODUCTION


Tinnitus is defined as the perception of sound without its actual presence in the environment. It has been the subject of a great number of studies, especially considering its consequences on patient's quality of life.
OBJECTIVE


This study aimed to investigate the effect of hearing aids and/or Ginkgo biloba extract EGb 761 on tinnitus in patients with hearing loss.
METHODS


This is a trial randomized-controlled treatment, parallel, double-blind, with three-arm. Thirty-three adults subjects were divided into three groups: group 1 - subjects undergoing drug therapy with Ginkgo biloba extract EGb 761; group 2 - individuals fitted with digital hearing aids; group 3 - individuals submitted to drug therapy with Ginkgo biloba extract EGb 761 and using hearing aids. The tinnitus handicap inventory and visual analogue scale were used to evaluate self-perception of tinnitus loudness and severity before treatment and 90 days after treatment.
RESULTS


This study demonstrated a significant correlation between tinnitus handicap inventory and visual analogue scale, before and after treatment. We observed a significant improvement in self-perception of tinnitus loudness and severity after 90 days of treatment with Ginkgo biloba extract EGb 761 and/or hearing aids. No correlation was found between tinnitus onset time and self-perception of tinnitus loudness and severity. Hearing aids were more effective in patients with a shorter tinnitus onset time and Ginkgo biloba extract was effective regardless of tinnitus duration.
CONCLUSIONS


It was possible to prove the effectiveness of the hearing aids and/or Ginkgo biloba extract EGb 761 treatment, which shows success in the control of tinnitus contributing to the improvement of this symptom.",2020,"Hearing aids were more effective in patients with a shorter tinnitus onset time and G. biloba extract was effective regardless of tinnitus duration.
","['761 and/or hearing aids', 'Thirty-three adults subjects', 'patients with hearing loss']","['biloba extract EGb', 'Ginkgo biloba extract (EGb 761', 'drug therapy with G. biloba extract EGb 761; group 2 - individuals fitted with digital hearing aids; group 3 - individuals submitted to drug therapy with G. biloba extract EGb 761 and using hearing aids', 'biloba extract', 'hearing aids and/or Ginkgo biloba extract EGb']","['tinnitus onset time and self-perception of tinnitus loudness and severity', 'tinnitus handicap inventory and visual analogue scale', 'self-perception of tinnitus loudness and severity', 'tinnitus improvement']","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C1095795', 'cui_str': 'EGb 761'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}]","[{'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",761.0,0.0590211,"Hearing aids were more effective in patients with a shorter tinnitus onset time and G. biloba extract was effective regardless of tinnitus duration.
","[{'ForeName': 'Camila L', 'Initials': 'CL', 'LastName': 'Radunz', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia, São Paulo, SP, Brazil.'}, {'ForeName': 'Cristina E', 'Initials': 'CE', 'LastName': 'Okuyama', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia, São Paulo, SP, Brazil.'}, {'ForeName': 'Fátima C A', 'Initials': 'FCA', 'LastName': 'Branco-Barreiro', 'Affiliation': 'Universidade Federal de São Paulo (UNIFESP), Departamento de Fonoaudiologia, São Paulo, SP, Brazil.'}, {'ForeName': 'Regina M S', 'Initials': 'RMS', 'LastName': 'Pereira', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia e Mestrado e Doutorado em Biotecnologia e Inovação em Saúde, São Paulo, SP, Brazil.'}, {'ForeName': 'Susana N', 'Initials': 'SN', 'LastName': 'Diniz', 'Affiliation': 'Universidade Anhanguera de São Paulo (UNIAN), Programa de Mestrado Profissional em Farmácia e Mestrado e Doutorado em Biotecnologia e Inovação em Saúde, São Paulo, SP, Brazil. Electronic address: dinizsusana@gmail.com.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2019.05.003']
588,32118387,Thirty-two weeks of randomized interdisciplinary therapy or combined physical training promote similar improvements in anthropometric and biochemical parameters of obese women.,"BACKGROUND


Obesity is a multicausal illness that generates large expenses to health systems and also for the families of obese individuals. It is important to note that obesity disrupts all systems, generating metabolic consequences that may be irreversible. Interdisciplinary therapy is recommended as the primary method for treating obesity. However, the cost of interdisciplinary treatment can be high due to the need for various professionals, from different areas of expertise. This study compares the effects of 32 weeks of physical training combined with interdisciplinary therapy on anthropometric and biochemical parameters in obese women.
METHODS


Seventy-six subjects were randomized into two groups: Group Physical Exercise (EXE) and Group Interdisciplinary Treatment (INTER), being evaluated in the initial moment and after 32 weeks. 30 subjects completed the intervention and were evaluated (EXE: N.=13; INTER: N.=17).
RESULTS


Psychobiological and biochemical variables were measured. EXE and INTER were similar before treatment and both showed significantly improvements in anthropometric and biochemical parameters after interventions, without difference between groups.
CONCLUSIONS


The results confirmed the relevant role of physical training or the interdisciplinary therapy on metabolic profile of obese women. We realized that physical training can be incorporated into public or private health systems as an alternative strategy for obesity control, especially in locations that do not have the possibility of offering a complete interdisciplinary therapy.",2020,"EXE and INTER were similar before treatment and both showed significantly improvements in anthropometric and biochemical parameters after interventions, without difference between groups.
","['obese women', '30 subjects completed the intervention and were evaluated (EXE: n=13; INTER: n=17', '76 subjects']","['physical training combined with interdisciplinary therapy', 'Group Physical Exercise (EXE) and Group Interdisciplinary Treatment (INTER', 'interdisciplinary therapy', 'physical training', 'combined physical training']","['anthropometric and biochemical parameters', 'EXE and INTER']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",76.0,0.0391068,"EXE and INTER were similar before treatment and both showed significantly improvements in anthropometric and biochemical parameters after interventions, without difference between groups.
","[{'ForeName': 'Letícia A', 'Initials': 'LA', 'LastName': 'Cerrone', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil - leticia.ac9@gmail.com.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Caranti', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Fidalgo', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ricardo B', 'Initials': 'RB', 'LastName': 'Sanches', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Maythe A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Renata R', 'Initials': 'RR', 'LastName': 'Astride', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Vanessa F', 'Initials': 'VF', 'LastName': 'Poli', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'de Campos', 'Affiliation': 'Cellula Mater Laboratory, Santos, SP, Brazil.'}, {'ForeName': 'Lila M', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Liu C', 'Initials': 'LC', 'LastName': 'Yi', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Dâmaso', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Cauê V', 'Initials': 'CV', 'LastName': 'Teixeira', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ricardo J', 'Initials': 'RJ', 'LastName': 'Gomes', 'Affiliation': 'Obesity Study Group, Federal University of São Paulo, Santos, SP, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10036-7']
589,31314661,A Randomized Clinical Trial Comparing the Impact of a Web-Based Multimedia Intervention Versus an Educational Pamphlet on Patient Outcomes in Breast Cancer Survivors with Chronic Secondary Lymphedema.,"Objective:  The purpose of this study was to evaluate the effects of a Web-based Multimedia Intervention (WBMI) for breast cancer-related lymphedema (BCRL) patients on symptom burden, function, psychological well-being, costs, and arm volume.  Methods:  Women with BCRL were randomized to intervention ( n  = 80) or control ( n  = 80) groups. The WBMI offered 12 modules, each of which took about 30 minutes to complete. The Pamphlet took about 2 hours to read. Data on symptom burden, psychological well-being, function, and costs were collected preintervention; and 1, 3, 6, and 12 months postintervention. A subgroup of 45 regional patients had arm extracellular fluid measured by bioimpedance at baseline and at 3, 6, and 12 months postintervention. Intervention perceived value was also captured.  Results:  A statistically significant difference ( p  = 0.011) was observed for rates of intervention completion, WBMI (58%), and Pamphlet (77%). With the exception of the number of biobehavioral symptoms (mood), no statistically significant differences between groups in symptom reduction were apparent between baseline and 1 or 12 months (effect sizes = 0.05-0.28,  p  > 0.05) based on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A). No statistically significant differences between the groups were observed for changes in other variables. The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  Conclusions:  WBMI participants experienced improved biobehavioral symptoms and higher perceived quality of information. The lack of significant differences on other variables may be due to the high percentage of participants who did not complete the WBMI.",2020,The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  ,"['breast cancer-related lymphedema (BCRL) patients on', 'Women with BCRL', 'Breast Cancer Survivors with Chronic Secondary Lymphedema']","['Web-Based Multimedia Intervention', 'Web-based Multimedia Intervention (WBMI', 'Educational Pamphlet']","['number of biobehavioral symptoms (mood', 'Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A', 'symptom reduction', 'WBMI', 'biobehavioral symptoms and higher perceived quality of information', 'symptom burden, psychological well-being, function, and costs', 'rates of intervention completion, WBMI', 'symptom burden, function, psychological well-being, costs, and arm volume']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema (disorder)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",12.0,0.107559,The WBMI was perceived as providing better self-care information than the Pamphlet ( p  = 0.001).  ,"[{'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Dietrich', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Davis', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'Sinclair', 'Affiliation': 'Center for Research Development and Scholarship, School of Nursing, Vanderbilt University, Nashville, Tennessee.'}]",Journal of women's health (2002),['10.1089/jwh.2019.7676']
590,32118385,The effects of leucine and whey protein supplementation with eight weeks of resistance training on strength and body composition.,"BACKGROUND


In past few decades, supplementation has become very popular within professional and recreational athletes. Most interested among supplements are protein and amino acids. Therefore, the purpose of this study was to examine the effects of leucine supplementation in comparison to whey protein supplementation with placebo group on strength and body composition during 8 weeks of resistance training program.
METHODS


Thirty male college athletes (mean age±SD =23.92±1.54 years) participated in this investigation and were randomly assigned to one of three groups: whey protein (WP, N.=10), leucine (LEU, N.=10) or placebo (PLA, N.=10). The WP, LEU and PLA performed resistance training for 8 weeks. Strength (1RM bench press, squat, shoulder press) and maximum pull-ups and body composition has been assessed and data was analyzed with mixed-design analysis of variance (P≤0.01).
RESULTS


The WP group achieved significantly greater (P≤0.01) increases in 1RM bench press than the LEU and PLA groups (+16 kg for WP; + 7.5 kg for LEU and + 5 kg for PLA). The LEU group achieved significantly greater gains (P≤0.01) in fat free mass, muscle mass and significantly decreases (P≤0.01) in fat mass compared to WP and PLA groups.
CONCLUSIONS


Whey protein supplementation in male collegiate athletes during resistance training achieved greater increase in strength than leucine and placebo groups, and leucine group achieved significantly greater improvement in body composition than whey protein and placebo groups.",2020,The WP group achieved significantly greater (p≤0.01) increases in 1RM bench press than the LEU and PLA groups (+16kg for WP; + 7.5kg for LEU and + 5kg for PLA).,"['Thirty male college athletes (mean age ± SD = 23.92 ± 1.54 years', 'male collegiate athletes']","['placebo', 'LEU', 'leucine supplementation', 'leucine and whey protein supplementation', 'whey protein (WP, n=10), leucine (LEU, n=10) or placebo']","['strength', '1RM bench press', 'Strength (1RM bench press, squat, shoulder press) and maximum pull-ups and body composition', 'body composition', 'strength and body composition']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0454325', 'cui_str': 'Shoulder press (regime/therapy)'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",30.0,0.033423,The WP group achieved significantly greater (p≤0.01) increases in 1RM bench press than the LEU and PLA groups (+16kg for WP; + 7.5kg for LEU and + 5kg for PLA).,"[{'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Obradović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Vukadinović Jurišić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Dušan', 'Initials': 'D', 'LastName': 'Rakonjac', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia - rakonjac992@gmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.09742-X']
591,32161366,Oxytocin induces long-lasting adaptations within amygdala circuitry in autism: a treatment-mechanism study with randomized placebo-controlled design.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD). To date, however, the impact of multiple-dose IN-OT treatment on human neural circuitry is largely unknown, and also the possibility that long-term IN-OT use may induce long-lasting neural adaptations remains unexplored. Using a double-blind, randomized, placebo-controlled, between-subject design (including 38 adult men with ASD), this treatment-mechanism study showed that 4 weeks of daily oxytocin administration (24 IU/day) significantly altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus) up to 4 weeks and 1 year post treatment. The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors. These observations contribute to a deeper mechanistic understanding of the neural substrates that underlie behavioral effects of multiple-dose IN-OT treatment, and provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala circuitry. Future studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural circuitry and its behavioral consequences.",2020,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"['38 adult men with ASD', 'autism']","['neuropeptide oxytocin (IN-OT', 'oxytocin', 'Oxytocin', 'placebo']","['altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}]",38.0,0.130252,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"[{'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium. Kaat.Alaerts@kuleuven.be.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dillen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Department of Neurosciences, Group Biomedical Sciences, Psychiatry Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0653-8']
592,31313886,Bifocals reduce strabismus in children with Down syndrome: Evidence from a randomized controlled trial.,"PURPOSE


Children with Down syndrome (DS) more often have strabismus, refractive errors, accommodative lags and reduced visual acuity (VA) than typically developing children. In this study, we compare the effects of bifocal glasses with those of unifocal glasses in children with DS. Changes in angle of strabismus, accommodation and refractive error were analysed in this paper.
METHODS


In a multicentre randomized controlled trial, 119 children with DS, aged 2-16, were randomly allocated for bifocal or unifocal glasses (with full correction of refractive error in cycloplegia). The 15 centres, all in the Netherlands, followed the participants for 1 year. Changes in refractive error, accommodative accuracy, strabismus, binocularity and stereopsis were compared across 4 subsequent visits.
RESULTS


Refractive errors and accommodative errors showed no significant change throughout the course of our study in either intervention group. The manifest angle of strabismus, however, reduced significantly in the bifocal group. This improvement was observed shortly after the children received their new correction (~6 weeks) (linear regression: t = 3.652, p < 0.001) and remained present in the final measurements after 1 year (linear regression: t = 3.604, p < 0.001). The percentage of children with positive binocularity and stereo tests showed no significant differences between the groups.
CONCLUSION


Bifocals with full correction of refractive error reduce the manifest angle of strabismus within a few weeks. No effects on accommodation, refractive error, stereopsis and binocularity occurred over the course of 1 year.",2020,"The percentage of children with positive binocularity and stereo tests showed no significant differences between the groups.
","['119 children with DS, aged 2-16', 'children with Down syndrome', 'children with DS', 'Children with Down syndrome (DS']",['bifocal or unifocal glasses (with full correction of refractive error in cycloplegia'],"['angle of strabismus, accommodation and refractive error', 'percentage of children with positive binocularity and stereo tests', 'refractive error, accommodative accuracy, strabismus, binocularity and stereopsis', 'accommodation, refractive error, stereopsis and binocularity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}]","[{'cui': 'C1275647', 'cui_str': 'Bifocals'}, {'cui': 'C0443337', 'cui_str': 'Unifocal (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0235238', 'cui_str': 'Ciliary muscle paresis'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0038379', 'cui_str': 'Phorias'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0034951', 'cui_str': 'Refractive Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0011586', 'cui_str': 'Stereopsis'}]",119.0,0.207774,"The percentage of children with positive binocularity and stereo tests showed no significant differences between the groups.
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'de Weger', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Cognitive Neuroscience, Radboud University Medical Centre Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Boonstra', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Cognitive Neuroscience, Radboud University Medical Centre Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Goossens', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Cognitive Neuroscience, Radboud University Medical Centre Nijmegen, Nijmegen, The Netherlands.'}]",Acta ophthalmologica,['10.1111/aos.14186']
593,31327162,Effect of Low-Level Laser Therapy versus Electroacupuncture on Postnatal Scanty Milk Secretion: A Randomized Controlled Trial.,"OBJECTIVE


Postnatal scanty milk secretion is a common complaint. Some physical and medical interventions were advocated to help milk production. These interventions should be effective and safe for the mother and the infant. This study aimed to compare the effects of low-level laser therapy and electroacupuncture on postnatal scanty milk secretion.
STUDY DESIGN


A randomized controlled study conducted on 60 healthy primiparous mothers with insufficient lactation. They were randomly divided into three equal groups: group A (control), group B (those who received low-power He-Ne laser beam on both breasts), and group C (those who received faradic current stimulation at Spleen 6, Liver 3, and Small Intestine 1 acupuncture points on both sides). All participants received 10 mg Domperidone three times a day and were given advice about lactation, nutrition, and fluid intake. Evaluation was done before and after the treatment program.
RESULTS


The mean serum prolactin, infant weight, and visual analog scale (VAS) score were significantly increased in the three groups posttreatment when compared with their corresponding levels pretreatment. Posttreatment serum prolactin was significantly elevated in group C more than the other two groups ( p  = 0.001 and 0.012, respectively). Also, it was significantly elevated in group B more than in group A ( p  = 0.001). The mean value of infant weight was significantly elevated in group C when compared with its corresponding values in both groups A ( p  = 0.001) and B ( p  = 0.029). The VAS score was significantly increased in both groups B and C when compared with group A ( p  = 0.001).
CONCLUSION


Electroacupuncture is more effective than low-level laser therapy in increasing postnatal scanty milk secretion.
CLINICAL TRIAL REGISTRATION


NCT03806062.",2020,"Posttreatment serum prolactin was significantly elevated in group C more than the other two groups ( p  = 0.001 and 0.012, respectively).","['Postnatal Scanty Milk Secretion', '60 healthy primiparous mothers with insufficient lactation']","['Electroacupuncture', 'Domperidone', 'low-power He-Ne laser beam on both breasts), and group C (those who received faradic current stimulation at Spleen 6, Liver 3, and Small Intestine 1 acupuncture points on both sides', 'Low-Level Laser Therapy versus Electroacupuncture', 'low-level laser therapy', 'low-level laser therapy and electroacupuncture']","['VAS score', 'mean value of infant weight', 'mean serum prolactin, infant weight, and visual analog scale (VAS) score', 'Posttreatment serum prolactin']","[{'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0443295', 'cui_str': 'Scanty (qualifier value)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020610', 'cui_str': 'Hypogalactia'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0458142', 'cui_str': 'Laser-generated electromagnetic radiation (physical force)'}, {'cui': 'C0222605', 'cui_str': 'Both breasts (body structure)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0490042,"Posttreatment serum prolactin was significantly elevated in group C more than the other two groups ( p  = 0.001 and 0.012, respectively).","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Maged', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Marwa E', 'Initials': 'ME', 'LastName': 'Hassanin', 'Affiliation': 'Department of Women Health, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Wafaa M', 'Initials': 'WM', 'LastName': 'Kamal', 'Affiliation': 'Department of Women Health, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr H', 'Initials': 'AH', 'LastName': 'Abbassy', 'Affiliation': 'Department of Reproductive Health and Family Planning, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alalfy', 'Affiliation': 'Department of Reproductive Health and Family Planning, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Ahmed N', 'Initials': 'AN', 'LastName': 'Askalani', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Lithy', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Nabil', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Farouk', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Hussein', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Bahaa', 'Initials': 'B', 'LastName': 'Hammad', 'Affiliation': 'Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt.'}]",American journal of perinatology,['10.1055/s-0039-1693428']
594,31299919,Effect of extended hours dialysis on markers of chronic kidney disease-mineral and bone disorder in the ACTIVE Dialysis study.,"BACKGROUND


Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD) is a significant cause of morbidity among haemodialysis patients and is associated with pathological changes in phosphate, calcium and parathyroid hormone (PTH). In the ACTIVE Dialysis study, extended hours dialysis reduced serum phosphate but did not cause important changes in PTH or serum calcium. This secondary analysis aimed to determine if changes in associated therapies may have influenced these findings and to identify differences between patient subgroups.
METHODS


The ACTIVE Dialysis study randomised 200 participants to extended hours haemodialysis (≥24 h/week) or conventional haemodialysis (≤18 h/week) for 12 months. Mean differences between treatment arms in serum phosphate, calcium and PTH; and among key subgroups (high vs. low baseline phosphate/PTH, region, time on dialysis, dialysis setting and frequency) were examined using mixed linear regression.
RESULTS


Phosphate binder use was reduced with extended hours (- 0.83 tablets per day [95% CI -1.61, - 0.04; p = 0.04]), but no differences in type of phosphate binder, use of vitamin D, dose of cinacalcet or dialysate calcium were observed. In adjusted analysis, extended hours were associated with lower phosphate (- 0.219 mmol/L [- 0.314, - 0.124; P < 0.001]), higher calcium (0.046 mmol/L [0.007, 0.086; P = 0.021]) and no change in PTH (0.025 pmol/L [- 0.107, 0.157; P = 0.713]). The reduction in phosphate with extended hours was greater in those with higher baseline PTH and dialysing at home.
CONCLUSION


Extended hours haemodialysis independently reduced serum phosphate levels with minimal change in serum calcium and PTH levels. With a few exceptions, these results were consistent across patient subgroups.
TRIAL REGISTRATION


Clinicaltrials.gov NCT00649298 . Registered 1 April 2008.",2019,"In the ACTIVE Dialysis study, extended hours dialysis reduced serum phosphate but did not cause important changes in PTH or serum calcium.","['200 participants to extended hours haemodialysis (≥24\u2009h/week) or', 'haemodialysis patients']","['extended hours dialysis', 'conventional haemodialysis']","['serum calcium and PTH levels', 'type of phosphate binder, use of vitamin D, dose of cinacalcet or dialysate calcium', 'chronic kidney disease-mineral and bone disorder', 'serum phosphate levels', 'serum phosphate, calcium and PTH']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1337242', 'cui_str': 'cinacalcet'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4076240', 'cui_str': 'CKD-MBD'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}]",200.0,0.094788,"In the ACTIVE Dialysis study, extended hours dialysis reduced serum phosphate but did not cause important changes in PTH or serum calcium.","[{'ForeName': 'Zhipeng', 'Initials': 'Z', 'LastName': 'Zhan', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, 2 Yinghuayuan E St, Chaoyang Qu, Beijing Shi, 100096, China.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia.'}, {'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Sunshine Coast University Hospital, Birtinya, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'University Health Network, Toronto, Canada.'}, {'ForeName': 'Chenggang', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'School of Social Development and Public Policy, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Scaria', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW, 1 King St, Newtown, Sydney, 2042, Australia. mjardine@georgeinstitute.org.au.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, 2 Yinghuayuan E St, Chaoyang Qu, Beijing Shi, 100096, China. zhangling5@medmail.com.cn.'}]",BMC nephrology,['10.1186/s12882-019-1438-3']
595,28378199,Comparison of Health Communication Channels for Reaching Hispanics About Biobanking: a Pilot Trial.,"Cancer education is essential for improving cancer prevention and biobanking knowledge among racial-ethnic minorities, with the goal of increasing diversity and representativeness of biospecimen collections. However, little is known about the communication modalities for optimal delivery of information. We examined feasibility of recruitment and compared communication modalities for delivering cancer prevention and biobanking education to Hispanics. Communication modalities were evaluated using participation rates and change in knowledge, attitudes, self-efficacy, intention, receptivity, and trust. Enrollment in a biobanking registry was a behavioral outcome. Community members in Ponce, Puerto Rico and Tampa, Florida were recruited. Participants (N = 254) were randomized to one of three communication modalities: standard dissemination (mailed materials); enhanced dissemination (mailed materials plus follow-up call); and 'charla' (face-to-face group discussion). Participants completed questionnaires about their knowledge, attitudes, self-efficacy, intentions, receptivity, and trust regarding biobanking and cancer prevention pre- and post-intervention. Knowledge, attitudes, and self-efficacy were improved among all three modalities. Although the greatest increases in knowledge were observed when the information was delivered via charla, the charla had the lowest participation rate. The standard and enhanced dissemination modalities were more feasible for delivering cancer prevention and biobanking education to Hispanics. Lack of differences among the three modalities suggests culturally tailored education may be sufficient to capture the community's intention to participate in biobanking research, regardless of the delivery method for the education. Results from this study contribute to the limited knowledge regarding Hispanics knowledge and intentions for biospecimen collection, and in the future may improve participation in this underrepresented group.",2018,"Communication modalities were evaluated using participation rates and change in knowledge, attitudes, self-efficacy, intention, receptivity, and trust.","['Community members in Ponce, Puerto Rico and Tampa, Florida were recruited', 'Participants (N\xa0=\xa0254']","[""communication modalities: standard dissemination (mailed materials); enhanced dissemination (mailed materials plus follow-up call); and 'charla' (face-to-face group discussion"", 'Health Communication Channels']","['knowledge', 'questionnaires about their knowledge, attitudes, self-efficacy, intentions, receptivity, and trust regarding biobanking and cancer prevention pre- and post-intervention', 'participation rates and change in knowledge, attitudes, self-efficacy, intention, receptivity, and trust', 'Knowledge, attitudes, and self-efficacy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0016253', 'cui_str': 'Florida'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1512347', 'cui_str': 'Health Communication'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",254.0,0.0196906,"Communication modalities were evaluated using participation rates and change in knowledge, attitudes, self-efficacy, intention, receptivity, and trust.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McIntyre', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA. Jessica.mcintyre@moffitt.org.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Jiménez', 'Affiliation': 'School of Behavioral and Brain Sciences, Ponce Health Sciences University, Ponce Research Institute, Ponce, Puerto Rico.'}, {'ForeName': 'Yonaira M', 'Initials': 'YM', 'LastName': 'Rivera', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Asencio', 'Affiliation': 'Department of Psychiatry and Human Behavior, Ponce Health Sciences University, Ponce Research Institute, Ponce, Puerto Rico.'}, {'ForeName': 'Eida M', 'Initials': 'EM', 'LastName': 'Castro-Figueroa', 'Affiliation': 'School of Behavioral and Brain Sciences, Ponce Health Sciences University, Ponce Research Institute, Ponce, Puerto Rico.'}, {'ForeName': 'Clement K', 'Initials': 'CK', 'LastName': 'Gwede', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Vadaparampil', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Corchado', 'Affiliation': 'Department of Psychiatry and Human Behavior, Ponce Health Sciences University, Ponce Research Institute, Ponce, Puerto Rico.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Wells', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Gwendolyn P', 'Initials': 'GP', 'LastName': 'Quinn', 'Affiliation': 'Health Outcomes and Behavior Department, Moffitt Cancer Center, 12902 Magnolia Drive, Tampa, FL, 33612, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-017-1214-7']
596,31272939,Temsirolimus versus Pazopanib (TemPa) in Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features: A Randomized Phase II Trial.,"BACKGROUND


Temsirolimus has level 1 evidence for initial treatment of poor-risk patients with advanced renal cell carcinoma (mRCC), but its efficacy has not been directly compared with an antiangiogenic tyrosine kinase inhibitor (vascular endothelial growth factor receptor tyrosine kinase inhibitor [VEGFR TKi]) in this setting.
OBJECTIVE


To evaluate temsirolimus versus pazopanib as first-line therapy in patients with mRCC, predominant clear-cell features, and clinical characteristics of a poor prognosis.
DESIGN, SETTING, AND PARTICIPANTS


A randomized (1:1) phase II trial in 69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center. Crossover to the alternative treatment upon discontinuation of the first-line agent was permitted.
INTERVENTION


Mechanistic target of rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs). Radiographic response was assessed by blinded radiologists. Efficacy outcomes were adjusted by prior nephrectomy status, prior interleukin-2 treatment, and the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score.
RESULTS AND LIMITATIONS


Thirty-five patients received temsirolimus and 34 received pazopanib upfront; 72% overall had poor risk by IMDC. Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210). Median OS was 7.1mo with temsirolimus and 11.9mo with pazopanib (adjusted HR 1.16, 95% CI 0.70-1.93; p=0.558), and ORRs were 5.9% and 21.2%, respectively (adjusted odds ratio 5.2, 95% CI 0.9-29.3; p=0.062). PRO measures favored pazopanib. Five patients discontinued first-line therapy due to adverse events.
CONCLUSIONS


Temsirolimus and pazopanib had modest activity in patients with poor-risk clear-cell mRCC, and therefore their use should be discouraged in this setting.
PATIENT SUMMARY


We evaluated outcomes of advanced renal cell carcinoma patients presenting with aggressive features when treated with temsirolimus or pazopanib as first-line therapy. Survival was <1yr for most, suggesting that more efficacious alternative treatments should be favored for these patients.",2020,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","['patients with mRCC', 'patients with poor-risk clear-cell mRCC', '69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center', 'Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features', 'advanced renal cell carcinoma patients presenting with aggressive features when treated with', 'poor-risk patients with advanced renal cell carcinoma (mRCC']","['Temsirolimus versus Pazopanib (TemPa', 'Temsirolimus and pazopanib', 'temsirolimus or pazopanib', 'rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib', 'pazopanib', 'pazopanib upfront']","['progression-free survival (PFS', 'Survival', 'Radiographic response', 'overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs', 'Median OS', 'ORRs', 'International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",69.0,0.0983514,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","[{'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ntannir@mdanderson.org.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Msaouel', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Ross', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Devine', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Graciela M Nogueras', 'Initials': 'GMN', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zita D', 'Initials': 'ZD', 'LastName': 'Lim', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Pruitt', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amado J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",European urology oncology,['10.1016/j.euo.2019.06.004']
597,7486112,Beta 2-adrenoceptor density of human lymphocytes after nitroprusside-induced hypotension.,"The present study was undertaken to assess the influence of nitroprusside-induced hypotension on beta 2-adrenoceptor density. Twenty-four patients undergoing nose-septum corrections under general anesthesia were allocated randomly to a nitroprusside or control group. beta 2-Receptor density on lymphocytes was measured by binding studies using (-)125-iodocyanopindolol. Lymphocyte subpopulations B, T, Thelper, Tsuppressor, and natural killer cells were determined simultaneously by flow cytometry. Five of 12 nitroprusside-treated patients developed significant intraoperative increases of epinephrine levels (+69% versus preoperatively) which were not seen in the remaining seven patients. In these five patients, beta 2-receptor density of unfractionated lymphocytes was 26% lower (P < 0.05) on the first day after surgery compared with preoperative values. Since no changes in proportions of lymphocyte subpopulations were observed, these results are not caused by redistribution phenomena inducing a decrease of subsets with a high number of beta receptors. These findings suggest that beta 2-adrenergic responsiveness might be diminished after nitroprusside treatment in some patients.",1995,Five of 12 nitroprusside-treated patients developed significant intraoperative increases of epinephrine levels (+69% versus preoperatively) which were not seen in the remaining seven patients.,"['human lymphocytes after nitroprusside-induced hypotension', 'Twenty-four patients undergoing nose-septum corrections under general anesthesia']","['nitroprusside or control group', 'nitroprusside-induced hypotension']","['beta 2-Receptor density on lymphocytes', 'Lymphocyte subpopulations B, T, Thelper, Tsuppressor, and natural killer cells', 'epinephrine levels', 'beta 2-receptor density of unfractionated lymphocytes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0028193', 'cui_str': 'Nitroprusside'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0028193', 'cui_str': 'Nitroprusside'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0201998', 'cui_str': 'Adrenaline measurement'}]",24.0,0.0264258,Five of 12 nitroprusside-treated patients developed significant intraoperative increases of epinephrine levels (+69% versus preoperatively) which were not seen in the remaining seven patients.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Dietrich', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zeiler', 'Affiliation': ''}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Alberts', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Anesthesia and analgesia,[]
598,7864411,Influence of intravenous administration of angiotensin-converting enzyme inhibitor enalaprilat on cardiovascular mediators in cardiac surgery patients.,"The renin-angiotensin system (RAS) is important in controlling and maintaining cardiovascular homeostasis. In a randomized, prospective study, the response to intravenous (i.v.) administration of the angiotensin-converting enzyme (ACE) inhibitor enalaprilat (0.06 mg/kg) on important controllers of the circulation was investigated in 14 patients undergoing aortocoronary bypass grafting with a mean arterial blood pressure (MAP) > 85 mm Hg after induction of anesthesia. Fourteen patients received saline solution as placebo (control group). Endothelin (ET), atrial natriuretic peptide (ANP), catecholamine (epinephrine, norepinephrine) plasma levels, and ACE activity were measured from arterial blood sampled before injection of enalaprilat or NaCl solution (baseline values), 10 min and 30 min thereafter, immediately before the start of cardiopulmonary bypass (CPB), immediately after CPB, and at the end of surgery. MAP, heart rate (HR), cardiac index (CI), and systemic vascular resistance (SVR) were also monitored. ACE activity was similar at baseline in both groups; after i.v. injection of enalaprilat, it significantly decreased (from 35.1 +/- 11 to 4.4 +/- 1.0 U.min-1.L-1 30 min after injection) and remained reduced until the end of the operation (295 +/- 31 min after injection). ANP plasma levels were increased beyond normal (> 100 pg/mL) at baseline in both groups. They increased significantly in the control patients, but remained almost unchanged in the enalaprilat-treated patients within the entire study period. Plasma concentration of ET also increased only in the control group and was increased after CPB (8.6 +/- 1.2 pg/mL at the end of the operation).(ABSTRACT TRUNCATED AT 250 WORDS)",1995,Plasma concentration of ET also increased only in the control group and was increased after CPB (8.6 +/-,"['cardiac surgery patients', 'Fourteen patients received', '14 patients undergoing aortocoronary bypass grafting with a mean arterial blood pressure (MAP) ']","['saline solution as placebo', 'angiotensin-converting enzyme (ACE) inhibitor enalaprilat', 'enalaprilat', 'angiotensin-converting enzyme inhibitor enalaprilat']","['ANP plasma levels', 'Endothelin (ET), atrial natriuretic peptide (ANP), catecholamine (epinephrine, norepinephrine) plasma levels, and ACE activity', 'MAP, heart rate (HR), cardiac index (CI), and systemic vascular resistance (SVR', 'ACE activity', 'cardiovascular mediators', 'Plasma concentration of ET']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0014027', 'cui_str': 'Enalaprilat'}]","[{'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079284', 'cui_str': 'Endothelium-Derived Vasoconstrictor Factors'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",14.0,0.106635,Plasma concentration of ET also increased only in the control group and was increased after CPB (8.6 +/-,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schindler', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Härter', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Görlach', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Anesthesia and analgesia,[]
599,9495402,"Economic considerations of the use of new anesthetics: a comparison of propofol, sevoflurane, desflurane, and isoflurane.","UNLABELLED


Cost control in anesthesia is no longer an option; it is a necessity. New anesthetics have entered the market, but economic differences in comparison to standard anesthetic regimens are not exactly known. Eighty patients undergoing either subtotal thyroidectomy or laparoscopic cholecystectomy were randomly divided into four groups, with 20 patients in each group. Group 1 received propofol 1%/sufentanil, Group 2 received desflurane/sufentanil, Group 3 received sevoflurane/sufentanil, and Group 4 received isoflurane/sufentanil (standard anesthesia) for anesthesia. A fresh gas flow of 1.5-2 L/min and 60% N2O in oxygen was used for maintenance of anesthesia, and atracurium was given for muscle relaxation. Concentrations of volatile anesthetics, propofol, and sufentanil were varied according to the patient's perceived need. Isoflurane, desflurane, and sevoflurane consumption was measured by weighing the vaporizers with a precision weighing machine. Biometric data, time of surgery, and time of anesthesia were similar in the four groups. Times for extubation and stay in the postanesthesia care unit (PACU) were significantly longer in the isoflurane group. Use of sufentanil and atracurium did not differ among the groups. Propofol patients required fewer additional drugs in the PACU (e.g., antiemetics), and thus showed the lowest additional costs in the PACU. Total (intra- and postoperative) costs were significantly higher in the propofol group ($30.73 per patient; $0.24 per minute of anesthesia). The costs among the inhalational groups did not differ significantly (approximately $0.15 per minute of anesthesia). We conclude that in today's climate of cost savings, a comprehensive pharmacoeconomic approach is needed. Although propofol-based anesthesia was associated with the highest cost, it is doubtful whether the choice of anesthetic regimen will lower the costs of an anesthesia department.
IMPLICATIONS


Cost analysis of anesthetic techniques is necessary in today's economic climate. Consumption of the new inhaled drugs sevoflurane and desflurane was measured in comparison to a standard anesthetic regimen using isoflurane and an IV technique using propofol. Propofol-based anesthesia was associated with the highest costs, whereas the costs of the new inhaled anesthetics sevoflurane and desflurane did not differ from those of a standard, isoflurane-based anesthesia regimen.",1998,Total (intra- and postoperative) costs were significantly higher in the propofol group ($30.73 per patient; $0.24 per minute of anesthesia).,['Eighty patients undergoing either'],"['sevoflurane/sufentanil', 'propofol, sevoflurane, desflurane, and isoflurane', 'propofol-based anesthesia', 'sevoflurane and desflurane', 'subtotal thyroidectomy or laparoscopic cholecystectomy', 'isoflurane/sufentanil (standard anesthesia', 'isoflurane and an IV technique using propofol', 'Isoflurane, desflurane, and sevoflurane consumption', 'atracurium', 'propofol', 'Propofol-based anesthesia', 'desflurane/sufentanil', 'volatile anesthetics, propofol, and sufentanil', 'Propofol', 'sufentanil and atracurium', 'propofol 1%/sufentanil', 'isoflurane']","['Biometric data, time of surgery, and time of anesthesia', 'Total (intra- and postoperative) costs', 'Times for extubation and stay in the postanesthesia care unit (PACU']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0022180', 'cui_str': 'Isoflurane'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0193790', 'cui_str': 'Subtotal thyroidectomy (procedure)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}]",80.0,0.0212026,Total (intra- and postoperative) costs were significantly higher in the propofol group ($30.73 per patient; $0.24 per minute of anesthesia).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Klinikum der Stadt Ludwigshafen, Akademisches Lehrkrankenhaus der Universität Mainz, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jaun', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kumle', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Heck', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mund', 'Affiliation': ''}]",Anesthesia and analgesia,[]
600,31801031,"Comparative Study of Implantable Collamer Lens Implantation in Treating Four Degrees of Myopia: Six-Month Observation of Visual Results, Higher-Order Aberrations, and Amplitude of Accommodation.","PURPOSE


To compare the visual and refractive outcomes, higher-order aberrations (HOAs), and amplitude of accommodation (AA) after implantable collamer lens (ICL) model V4c implantation in four degrees of myopia.
METHODS


One hundred and thirty-seven myopic eyes (137 patients) undergoing ICL implantation were included and divided into four groups: Group 1 with spherical equivalent (SE) ≤-6.0D, Group 2 with SE from -6.13D to -9.0D, Group 3 with SE from -9.13D to -12.0D, and Group 4 with SE from -12.13D to -18.0D. The postoperative visits were scheduled at 1 day, 1 week, 1 month, 3 months, and 6 months. Visual and refractive outcomes, HOAs and AA were observed and compared.
RESULTS


At 6 months postoperatively, the uncorrected distance visual acuity (UDVA) in Group 4 was worse than the values in the other groups (all  p  < .05). Meanwhile, Group 4 had more eyes with corrected distance visual acuity (CDVA) improvement than the other groups. Furthermore, 96%, 100%, 100%, and 81% of eyes had an SE within ±0.5D in Group 1, Group 2, Group 3, and Group 4 ( p  < .05 between Group 4 and the other groups), respectively. The postoperative UDVA and SE remained stable in all groups. No significant change in total HOAs was found between preoperative and postoperative values for each group. However, quatrefoil increased in each group, whereas trefoil was induced in all groups except for Group 1. Negative spherical aberration was induced in Group 3 and Group 4. AA significantly decreased 1 week postoperatively and gradually improved in each group. Although AA improved to the preoperative level in Group 1 at 3 months postoperatively, it was still lower than the preoperative level in the other groups.
CONCLUSIONS


In treating different degrees of myopia with ICL implantation, differences were observed in terms of CDVA improvement, SE predictability, HOAs induction, and accommodation recovery.",2020,"In treating different degrees of myopia with ICL implantation, differences were observed in terms of CDVA improvement, SE predictability, HOAs induction, and accommodation recovery.","['4 degrees of myopia', 'Methods  One hundred and forty-two myopic eyes (142 patients) undergoing ICL implantation', 'Treating Four Degrees of Myopia']","['Implantable Collamer Lens Implantation', 'implantable collamer lens (ICL) model V4c implantation']","['uncorrected distance visual acuity (UDVA', 'Visual and refractive outcomes, HOAs and AA', 'Negative spherical aberration', 'postoperative visits', 'CDVA improvement, SE predictability, HOAs induction, and accommodation recovery', 'visual and refractive outcomes, higher order aberrations (HOAs), and amplitude of accommodation (AA', 'postoperative UDVA and SE', 'total HOAs', 'corrected distance visual acuity (CDVA) improvement', 'Visual Results, Higher Order Aberrations, and Amplitude of Accommodation', 'quatrefoil']","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit (finding)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",142.0,0.0241137,"In treating different degrees of myopia with ICL implantation, differences were observed in terms of CDVA improvement, SE predictability, HOAs induction, and accommodation recovery.","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wan', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Houfa', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}, {'ForeName': 'Yabo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Eye Center, Second Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China.'}]",Current eye research,['10.1080/02713683.2019.1701690']
601,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
602,30875669,Pilot study of a lifestyle intervention for bipolar disorder: Nutrition exercise wellness treatment (NEW Tx).,"BACKGROUND


Individuals with bipolar disorder (BD) are more likely than the general population to develop risk factors associated with cardiovascular disease, one of the leading causes of morbidity and mortality in this clinical population. To address this disproportionate medical burden, we developed Nutrition Exercise and Wellness Treatment (NEW Tx), a lifestyle intervention for individuals with BD.
METHODS


In this study, participants were randomized to NEW Tx (n = 19) or a treatment as usual waitlist (n = 19). We examine the intervention's efficacy to improve the physical and psychological outcomes of individuals with BD. Assessors were blind to participant condition throughout study duration.
RESULTS


The NEW Tx group reported increased weekly exercise duration and overall functioning, and decreased depression and illness severity over the study duration. However, only improvements in functioning were significantly greater in the NEW Tx group than in the control group. There were no group differences in weight loss or mood symptoms over the study duration.
LIMITATIONS


Limitations to this study include lack of objective measurement of exercise and a small and relatively homogeneous sample.
CONCLUSIONS


These data suggest that a manualized lifestyle intervention for BD may not be ideal to improve lifestyle changes in this clinical population. Further research is needed to pilot personalized approaches to creating a healthy lifestyle in BD.",2019,"The NEW Tx group reported increased weekly exercise duration and overall functioning, and decreased depression and illness severity over the study duration.","['individuals with BD', 'Individuals with bipolar disorder (BD', 'bipolar disorder']","['Nutrition Exercise and Wellness Treatment (NEW Tx), a lifestyle intervention', 'lifestyle intervention', 'Nutrition exercise wellness treatment (NEW Tx']","['weekly exercise duration and overall functioning, and decreased depression and illness severity', 'weight loss or mood symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0476147,"The NEW Tx group reported increased weekly exercise duration and overall functioning, and decreased depression and illness severity over the study duration.","[{'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, United States. Electronic address: lsylvia2@partners.org.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Pegg', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Dufour', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Janos', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Bernstein', 'Affiliation': 'Harvard University, Department of Psychology, 33 Kirkland Street, Cambridge, MA 02138, United States.'}, {'ForeName': 'Weilynn C', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'McLean Hospital, Gunderson Residence, 115 Mill Street, Belmont, MA 02478, United States.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States; Harvard University, Department of Biostatistics, 677 Huntington Avenue, Boston, MA 02115, United States.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Ellard', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, United States.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, United States.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Massachusetts General Hospital, Department of Psychiatry, Dauten Family Center for Bipolar Treatment Innovation, 50 Staniford Street, Suite 580, Boston, MA 02114, United States; Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.03.033']
603,8424497,Influence of different glucose-insulin-potassium regimes on glucose homeostasis and hormonal response in cardiac surgery patients .,"Intravenous infusion of glucose/insulin in combination with potassium (GIK) is an often used technique to improve myocardial preservation in cardiac surgery. In a randomized study in 50 patients undergoing elective aortocoronary bypass grafting with good ventricular function, the influence on glucose homeostasis and hormonal response to four different glucose/insulin regimes were compared to an untreated control: 1) 50 g of glucose mixed with 100 U of human insulin (HI/100); 2) 50 g of glucose mixed with 100 U of bovine insulin (BI/100); 3) 50 g of glucose mixed with 50 U of human insulin (HI/50); and 4) 50 g of glucose mixed with 50 U of bovine insulin (BI/50) [corrected]. Glucose/insulin were given in combination with 70 mmol of potassium 40 min before beginning the operation. In addition to blood glucose concentrations various endocrine variables were studied before, during and after cardiopulmonary bypass (CPB). Hemodynamic data (arterial blood pressure, heart rate, cardiac index, systemic vascular resistance) were similar in all five groups. Inotropic support after CPB was necessary in none of the patients. Blood glucose levels showed no differences among all GIK groups (groups 1-4) but were significantly higher than in the control patients. The incidence of severely reduced (< 50 mg/dL) or elevated blood glucose level (> 300 mg/dL) did not differ between HI- and BI-treated patients but was significantly lower in the untreated control. Insulin plasma level increased significantly after infusion of GIK with higher levels in HI- than BI-treated patients (P < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)",1993,"Hemodynamic data (arterial blood pressure, heart rate, cardiac index, systemic vascular resistance) were similar in all five groups.","['cardiac surgery patients ', '50 patients undergoing elective aortocoronary bypass grafting with good ventricular function, the influence on glucose homeostasis and hormonal response to four different']","['Glucose/insulin were given in combination with 70 mmol of potassium', 'glucose-insulin-potassium regimes', 'glucose/insulin in combination with potassium (GIK', 'glucose/insulin regimes were compared to an untreated control: 1) 50 g of glucose mixed with 100 U of human insulin (HI/100); 2) 50 g of glucose mixed with 100 U of bovine insulin (BI/100); 3) 50 g of glucose mixed with 50 U of human insulin (HI/50); and 4) 50 g of glucose mixed with 50 U of bovine insulin (BI/50) [corrected']","['Blood glucose levels', 'Insulin plasma level', 'elevated blood glucose level', 'glucose homeostasis and hormonal response', 'Hemodynamic data (arterial blood pressure, heart rate, cardiac index, systemic vascular resistance']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0557978', 'cui_str': 'Insulin regime (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0304866', 'cui_str': 'Beef insulin (substance)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0495706'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",50.0,0.0246977,"Hemodynamic data (arterial blood pressure, heart rate, cardiac index, systemic vascular resistance) were similar in all five groups.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Knothe', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zickmann', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dünnes', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dapper', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Anesthesia and analgesia,[]
604,31248662,"Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension.","BACKGROUND


Metabolic acidosis, a complication of chronic kidney disease, causes protein catabolism and bone demineralisation and is associated with adverse kidney outcomes and mortality. Veverimer, a non-absorbed, counterion-free, polymeric drug candidate selectively binds and removes hydrochloric acid from the gastrointestinal lumen.
METHODS


We did a multicentre, randomised, blinded, placebo-controlled, 40-week extension of a 12-week parent study at 29 sites (hospitals and specialty clinics) in seven countries (Bulgaria, Georgia, Hungary, Serbia, Slovenia, Ukraine, and the USA). Eligible patients were those with chronic kidney disease (estimated glomerular filtration rate 20-40 mL/min per 1·73 m 2 ) and metabolic acidosis (serum bicarbonate 12-20 mmol/L), who had completed the 12-week parent study, for which they were randomly assigned (4:3) to veverimer (6 g/day) or placebo as oral suspensions in water with food. Participants in the extension continued with the same treatment assignment as in the parent study. The primary endpoint was safety; the four secondary endpoints assessed the long-term effects of veverimer on serum bicarbonate concentration and physical functioning. The safety analysis set was defined as all patients who received any amount of study drug. This trial is registered at ClinicalTrials.gov, number NCT03390842, and has now completed.
FINDINGS


Participants entered the study between Dec 20, 2017, and May 4, 2018. Of the 217 patients randomly assigned to treatment in the parent study (124 to veverimer and 93 to placebo), 196 patients (114 veverimer and 82 placebo) continued on their blinded randomised treatment assignment into this 40-week extension study. Compared with placebo, fewer patients on veverimer discontinued treatment prematurely (3% vs 10%, respectively), and no patients on veverimer discontinued because of an adverse event. Serious adverse events occurred in 2% of veverimer-treated patients and in 5% of placebo patients (two of whom died). Renal system adverse events were reported in 8% and 15% in the veverimer and placebo groups, respectively. More patients on veverimer than placebo had an increase in bicarbonate (≥4 mmol/L or normalisation) at week 52 (63% vs 38%, p=0·0015) and higher bicarbonate concentrations were observed with veverimer than placebo at all timepoints starting at week 1 (p<0·001). Veverimer resulted in improved patient-reported physical functioning (Kidney Disease and Quality of Life-Physical Function Domain) versus placebo with a mean placebo-subtracted change at end of treatment of 12·1 points (SE 3·3; p<0·0001). Time to do the repeat chair stand test improved by 4·3 s (1·2) on veverimer versus 1·4 s (1·2) on placebo (p<0·0001).
INTERPRETATION


In patients with chronic kidney disease and metabolic acidosis, veverimer safely and effectively corrected metabolic acidosis and improved subjective and objective measures of physical function.
FUNDING


Tricida.",2019,Veverimer resulted in improved patient-reported physical functioning (Kidney Disease and Quality of Life-Physical Function Domain) versus placebo with a mean placebo-subtracted change at end of treatment of 12·1 points (SE 3·3; p<0·0001).,"['patients with metabolic acidosis in chronic kidney disease', '217 patients randomly assigned to treatment in the parent study (124 to veverimer and 93 to', 'Participants entered the study between Dec 20, 2017, and May 4, 2018', '196 patients (114 veverimer and 82', '29 sites (hospitals and specialty clinics) in seven countries (Bulgaria, Georgia, Hungary, Serbia, Slovenia, Ukraine, and the USA', 'Eligible patients were those with chronic kidney disease (estimated glomerular filtration rate 20-40 mL/min per 1·73 m 2 ) and metabolic acidosis (serum bicarbonate 12-20 mmol/L), who had completed the 12-week parent study', 'patients with chronic kidney disease and metabolic acidosis']","['veverimer', 'placebo']","['patient-reported physical functioning (Kidney Disease and Quality of Life-Physical Function Domain', 'Renal system adverse events', 'long-term effects of veverimer on serum bicarbonate concentration and physical functioning', 'bicarbonate', 'Serious adverse events', 'bicarbonate concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0036708', 'cui_str': 'Serbia'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C3811844'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3654009', 'cui_str': 'RENAL SYSTEM'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023983', 'cui_str': 'Effects, Long-Term'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}]",217.0,0.534008,Veverimer resulted in improved patient-reported physical functioning (Kidney Disease and Quality of Life-Physical Function Domain) versus placebo with a mean placebo-subtracted change at end of treatment of 12·1 points (SE 3·3; p<0·0001).,"[{'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Baylor Scott & White Health and Wellness Center, Dallas, TX, USA. Electronic address: donald.wesson@bswhealth.org.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Mathur', 'Affiliation': 'MathurConsulting, Woodside, CA, USA.'}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Division of Nephrology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Stasiv', 'Affiliation': 'Tricida, South San Francisco, CA, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Parsell', 'Affiliation': 'Tricida, South San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'PharmaStat, Newark, CA, USA.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Klaerner', 'Affiliation': 'Tricida, South San Francisco, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bushinsky', 'Affiliation': 'University of Rochester School of Medicine, Rochester, NY, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31388-1']
605,1731540,Influence of five different priming solutions on platelet function in patients undergoing cardiac surgery.,"The ideal choice of a priming solution of the cardiopulmonary bypass (CPB) and its influence on the hemostatic system are not clear. Addition of albumin was reported to inhibit platelet damaging by blood-surface interactions (""coating""). To explore this possibility in 60 consecutive male patients undergoing elective aortocoronary bypass grafting, five different priming solutions were randomly used: (1) 1000 mL of 5% dextrose + 1000 mL of Ringer's solution (RS) + 250 mL of 5% human albumin (HA); (2) 1850 mL of RS + 400 mL of 20% HA; (3) 1750 mL of RS + 500 mL of 10% low molecular weight hydroxyethyl starch (molecular weight average: 200,000; molar substitution ratio: 0.5); (4) 1750 mL of RS + 500 mL of 3.5% gelatin; (5) 2250 mL of RS. Platelet function was studied by aggregometry (= turbidometric technique; 1.0 and 2.0 mumol/L of adenosine diphosphate (ADP), 4 microL/mL of collagen, 25 mumol/L of epinephrine) before, during, and after CPB until the first postoperative day. Blood loss and need for homologous blood was not different between the groups. During CPB, maximum platelet aggregation induced by ADP was least compromised in group 1 and group 4. At the end of the operation ADP-induced aggregation increased in group 1 (+27%), whereas aggregation was decreased in the other priming solution groups. A significant increase in maximum aggregation was found in group 1 even on the first postoperative day (+132% +/- 16%). Collagen-induced aggregation was also least compromised in group 1. Epinephrine-induced platelet aggregation did not change and was similar for all groups. Maximum gradient of aggregation was influenced in an identical way as maximum aggregation.(ABSTRACT TRUNCATED AT 250 WORDS)",1992,Blood loss and need for homologous blood was not different between the groups.,"['patients undergoing cardiac surgery', '60 consecutive male patients undergoing elective aortocoronary bypass grafting, five different priming solutions']","['adenosine diphosphate (ADP), 4 microL/mL of collagen, 25 mumol/L of epinephrine', 'Epinephrine', 'cardiopulmonary bypass (CPB', ""dextrose + 1000 mL of Ringer's solution (RS) + 250 mL of 5% human albumin (HA); (2) 1850 mL of RS + 400 mL of 20% HA; (3) 1750 mL of RS + 500 mL of 10% low molecular weight hydroxyethyl starch"", 'albumin']","['aggregation', 'platelet aggregation', 'Maximum gradient of aggregation', 'Platelet function', 'platelet function', 'maximum aggregation', 'Collagen-induced aggregation', 'Blood loss and need for homologous blood', 'operation ADP-induced aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0587370', 'cui_str': 'Aortocoronary bypass grafting (procedure)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0073386', 'cui_str': ""Ringer's Solution""}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517606', 'cui_str': '1750'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]","[{'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}]",60.0,0.0410028,Blood loss and need for homologous blood was not different between the groups.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zickmann', 'Affiliation': ''}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Ballesteros', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Stertmann', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Anesthesia and analgesia,[]
606,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
607,31804404,"A Prospective, Randomized Trial Comparing Respiratory Status During Anesthesia for Airway Stenting: Spontaneous Respiration Versus Controlled Ventilation With Muscle Relaxants.","BACKGROUND


Airway stenting is a procedure in which a stent is inserted into a stenotic site of the airway. The safest method of ventilation for airway stenting is controversial. A prospective randomized interventional study was conducted on airway stenting. We conducted this study to investigate whether controlled ventilation with muscle relaxants (MR) during airway stenting reduces the incidence of desaturation events (percutaneous oxygen saturation [SpO2] <95%) in comparison with spontaneous respiration (SP).
METHODS


Sixty-four patients were enrolled at our hospital between April 2016 and August 2018, and were randomly assigned to the controlled ventilation with MR group or SP group. For anesthesia, total intravenous anesthesia with propofol target-controlled infusion and remifentanil was performed. In the SP group, SP was maintained. In the MR group, a rigid bronchoscope was inserted after the administration of MR to perform controlled ventilation. The incidence of desaturation events was analyzed by logistic regression adjusted by the preoperative respiratory state and stenotic site of the airway.
RESULTS


The incidence of desaturation events in the SP and MR groups was 75.0% (24/32) and 9.7% (3/31), respectively, with an odds ratio of 0.04 (95% confidence interval, 0.01-0.16, reference = SP group; P < .001). In the SP group, the mean intraoperative pH was lower than that in the MR group (7.2 ± 0.1 vs 7.4 ± 0.1, respectively; P < .001). In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
CONCLUSIONS


Controlled ventilation with MR during airway stenting reduced the incidence of desaturation events, maintaining a favorable respiratory status.",2020,"In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
","['comparison with spontaneous respiration (SP', 'Sixty-four patients were enrolled at our hospital between April 2016 and August 2018']","['controlled ventilation with MR group or SP', 'propofol target-controlled infusion and remifentanil', 'rigid bronchoscope', 'controlled ventilation with muscle relaxants (MR']","['incidence of desaturation events', 'mean partial pressure of arterial carbon dioxide (PaCO2', 'mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio', 'mean intraoperative pH']","[{'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0179435', 'cui_str': 'Rigid bronchoscope (physical object)'}, {'cui': 'C0026827', 'cui_str': 'Hypomyotonia'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}]",64.0,0.0447255,"In this group, the mean partial pressure of arterial carbon dioxide (PaCO2) was higher (70.2 ± 17.0 mm Hg vs 40.5 ± 8.0 mm Hg, respectively; P < .001) and the mean partial pressure of oxygen in the arterial blood/fraction of the inspiratory oxygen ratio was lower (263.1 ± 64.2 mm Hg vs 396.4 ± 69.4 mm Hg, respectively; P < .001).
","[{'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Okamoto', 'Affiliation': 'From the *Department of Anesthesiology †Department of Clinical Research Planning and Management, Clinical Research Center ‡Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Namie', 'Initials': 'N', 'LastName': 'Somiya', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'M Saito', 'Affiliation': ''}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kada', 'Affiliation': ''}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Oki', 'Affiliation': ''}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tomita', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004544']
608,30312190,Predicting Engagement With Online Walking Promotion Among Metropolitan and Rural Cancer Survivors.,"BACKGROUND


Physical activity has numerous associated benefits for cancer survivors. Compared with their urban counterparts, rural Australians experience a health disadvantage, including poorer survival rate after diagnosis of cancer.
OBJECTIVE


The aims of this study were to test the effectiveness of an online 12-week walking intervention designed for cancer survivors and explore region-specific psychological predictors of behavior change.
METHODS


This was a quasi-randomized controlled trial of an online resource designed according to Social Cognitive Theory and Self-determination Theory, based on individualized goal setting. Measures of habitual walking, motivation, and self-efficacy were taken at baseline, postintervention, and 3-month follow-up in an intervention group (n = 46) and active control group (n = 45). The control group was provided a pedometer but did not have access to the online program.
RESULTS


An increase in steps/day at 12 weeks was observed in both groups, with a larger increase in the intervention group; these increases were not sustained at the 3-month follow-up. Psychological predictors of maintained change in steps per day (motivation, barrier self-efficacy, and relapse self-efficacy) did not differ between metropolitan and rural participants. Changes in steps per day among intervention participants were predicted by changes in relapse self-efficacy and barrier self-efficacy.
CONCLUSIONS


The intervention was successful in increasing physical activity postintervention; however, changes were not maintained at follow-up. There were no region-specific predictors of engagement in the intervention.
IMPLICATIONS FOR PRACTICE


Nurses are seamlessly positioned to promote health interventions like walking. Nurses should reframe physical activity with patients so that relapse is seen as common and possibly inevitable when adopting a regular physical activity habit.",2020,"An increase in steps/day at 12 weeks was observed in both groups, with a larger increase in the intervention group; these increases were not sustained at the 3-month follow-up.","['Metropolitan and Rural Cancer Survivors', 'cancer survivors', 'metropolitan and rural participants']",['Online Walking Promotion'],"['habitual walking, motivation, and self-efficacy', 'survival rate', 'Psychological predictors of maintained change in steps per day (motivation, barrier self-efficacy, and relapse self-efficacy', 'relapse self-efficacy and barrier self-efficacy']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",46.0,0.026825,"An increase in steps/day at 12 weeks was observed in both groups, with a larger increase in the intervention group; these increases were not sustained at the 3-month follow-up.","[{'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Frensham', 'Affiliation': 'Author Affiliations: Adelaide Nursing School, Faculty of Health and Medical Sciences, Adelaide University (Dr Frensham); and Sansom Institute for Health Research, School of Health Sciences, University of South Australia, Adelaide, Australia (Drs Parfitt and Dollman).'}, {'ForeName': 'Gaynor', 'Initials': 'G', 'LastName': 'Parfitt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dollman', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000649']
609,31243692,Low-Intensity Resistance Training and Compression Garment in the Management of Breast Cancer-Related Lymphedema: Single-Blinded Randomized Controlled Trial.,"There is limited evidence regarding the combined effect of exercise and compression garment on breast cancer-related lymphedema (BCRL). Therefore, we investigate the effect of low-intensity resistance training alone or in combination with a compression garment on lymphedema volume, self-reported lymphedema symptoms, and shoulder mobility and function. A total of 60 women with unilateral BCRL were randomly assigned to low-intensity resistance exercises (Rex group, n = 30) or exercises and compression garment (Rex-Com-group, n = 30). Both groups take part in exercises program consisted of 10-12 repetitions at 50 to 60% of one repetition maximum (IRM), three times weekly, for 8 weeks. The primary outcome was lymphedema volume determined by percentage reduction of excess limb volume (ELV). Secondary outcomes were lymphedema symptoms (pain, heaviness, and tightness) and shoulder mobility and function using the disabilities of the arm, shoulder, and hand (DASH) questionnaire. All measurements were standardized and performed before (week 0, W0), after the intervention (week 8, W8), and at follow-up (week 12, W12). A significant reduction in percentage of ELV (p < 0.01), pain severity (p < 0.05), a sensation of heaviness (p < 0.05) and tightness (p < 0.001), and improvement in shoulder range of motion (p < 0.05) and function on DASH scores (p < 0.05) were observed at W8 and W12 in both groups. However, no between-group differences were observed over time. These findings suggest that low-intensity resistance training, irrespective of garment use, can effectively reduce limb volume and lymphedema symptoms, and increase shoulder mobility and function.",2020,"A significant reduction in percentage of ELV (p < 0.01), pain severity (p < 0.05), a sensation of heaviness (p < 0.05) and tightness (p < 0.001), and improvement in shoulder range of motion (p < 0.05) and function on DASH scores (p < 0.05) were observed at W8 and W12 in both groups.","['60 women with unilateral BCRL', 'Breast Cancer-Related Lymphedema']","['low-intensity resistance training alone or in combination with a compression garment', 'exercise and compression garment', 'low-intensity resistance exercises (Rex group, n\u2009=\u200930) or exercises and compression garment (Rex-Com-group, n\u2009=\u200930', 'Low-Intensity Resistance Training and Compression Garment']","['tightness', 'limb volume and lymphedema symptoms', 'function on DASH scores', 'lymphedema volume, self-reported lymphedema symptoms, and shoulder mobility and function', 'shoulder range of motion', 'lymphedema symptoms (pain, heaviness, and tightness) and shoulder mobility and function using the disabilities of the arm, shoulder, and hand (DASH) questionnaire', 'percentage of ELV', 'lymphedema volume determined by percentage reduction of excess limb volume (ELV', 'pain severity', 'shoulder mobility and function', 'sensation of heaviness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2985539', 'cui_str': 'Compression garment (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0324505', 'cui_str': 'Rex'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439816', 'cui_str': 'Tight'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0581912', 'cui_str': 'Heaviness sensation'}]",60.0,0.0512478,"A significant reduction in percentage of ELV (p < 0.01), pain severity (p < 0.05), a sensation of heaviness (p < 0.05) and tightness (p < 0.001), and improvement in shoulder range of motion (p < 0.05) and function on DASH scores (p < 0.05) were observed at W8 and W12 in both groups.","[{'ForeName': 'Mohammed T A', 'Initials': 'MTA', 'LastName': 'Omar', 'Affiliation': 'Physical Therapy Department for Surgery, Faculty of Physical Therapy, Cairo University, 7 Ahmad Al-Zayat St., Bain El-Sarayat, Giza, 12612, Egypt. dr.Taher_m@yahoo.com.'}, {'ForeName': 'Rehab F M', 'Initials': 'RFM', 'LastName': 'Gwada', 'Affiliation': 'Physical Therapy Department, National Heart Institute, Giza, Egypt.'}, {'ForeName': 'Ghada S M', 'Initials': 'GSM', 'LastName': 'Omar', 'Affiliation': 'Physical Therapy Department for Surgery, Faculty of Physical Therapy, Cairo University, 7 Ahmad Al-Zayat St., Bain El-Sarayat, Giza, 12612, Egypt.'}, {'ForeName': 'Rokia M', 'Initials': 'RM', 'LastName': 'El-Sabagh', 'Affiliation': 'Physical Therapy Department, El-Mattaria Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Abd-El Aziz E', 'Initials': 'AAE', 'LastName': 'Mersal', 'Affiliation': 'Surgery Department, El-Mattaria Teaching Hospital, Cairo, Egypt.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01564-9']
610,31800490,Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicentre Randomized Controlled PORTAS-3 Trial (DRKS 00004900).,"OBJECTIVES


PORTAS-3 was designed to compare the frequency of pneumothorax or haemothorax in a primary open versus closed strategy for port implantation.
BACKGROUND DATA


The implantation strategy for totally implantable venous access ports with the optimal benefit/risk ratio remains unclear.
METHODS


PORTAS-3 was a multicentre, randomized, controlled, parallel-group superiority trial. Adult patients with oncological disease scheduled for elective port implantation were randomized to a primary open or closed strategy. Primary endpoint was the rate of pneumothorax or haemothorax. Assuming a difference of 2.5% between the 2 groups, a sample size of 1154 patients was needed to prove superiority of the open group. A logistic regression model after the intention-to-treat principle was applied for analysis of the primary endpoint.
RESULTS


Between November 9, 2014 and September 5, 2016, 1205 patients were randomized. Of these, 1159 (open n = 583; closed n = 576) were finally analyzed. The rate of pneumothorax or haemothorax was significantly reduced with the open strategy [odds ratio 0.27, 95% confidence interval (CI) 0.09-0.88; P = 0.029]. Operation time was shorter for the closed strategy. Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups.
CONCLUSION


A primary open strategy by cut-down of the cephalic vein, if necessary enhanced by a modified Seldinger technique, reduces the frequency of pneumothorax or haemothorax after central venous port implantation significantly compared with a closed strategy by primary puncture of the subclavian vein without routine sonographic guidance. Therefore, open surgical cut-down should be the reference standard for port implantation in comparable cohorts.
TRIAL REGISTRATION


German Clinical Trials Register DRKS 00004900.",2020,"Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups.
","['Between November 9, 2014 and September 5, 2016', '1205 patients were randomized', 'Adult patients with oncological disease scheduled for elective port implantation', '1159 (open n = 583; closed n = 576']","['primary open or closed strategy', 'closed strategy by primary puncture of the subclavian vein without routine sonographic guidance', 'Primary Open Versus Closed Implantation Strategy for Totally Implantable Venous Access Ports']","['rate of pneumothorax or haemothorax', 'tolerability, morbidity, dose rate of radiation, and 30-day mortality', 'frequency of pneumothorax or haemothorax', 'Operation time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0038532', 'cui_str': 'Subclavian Vein'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1275732', 'cui_str': 'Subcutaneous port'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",1205.0,0.202106,"Primary success rates, tolerability, morbidity, dose rate of radiation, and 30-day mortality did not differ significantly between the groups.
","[{'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Matthes', 'Initials': 'M', 'LastName': 'Hackbusch', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden Technical University, National Center for Tumor Diseases Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bork', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden Technical University, National Center for Tumor Diseases Dresden, Dresden, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kotschenreuther', 'Affiliation': 'Department of General, Visceral, Thoracic and Vascular Surgery, Klinikum Passau, Passau, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Heupel', 'Affiliation': 'Department of General, Visceral, Thoracic and Vascular Surgery, Klinikum Passau, Passau, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': 'Department of Surgery, Regensburg University Hospital, Regensburg, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'Department of Surgery, Regensburg University Hospital, Regensburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mattulat', 'Affiliation': 'Department of General Surgery, Alb Fils Hospitals, Göppingen, Germany.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Pintér', 'Affiliation': 'Department of General, Visceral, Thoracic and Vascular Surgery, Lukas Hospital Neuss, Neuss, Germany.'}, {'ForeName': 'Christoph M', 'Initials': 'CM', 'LastName': 'Seiler', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Joseph Hospital Warendorf, Warendorf, Germany.'}, {'ForeName': 'Carsten N', 'Initials': 'CN', 'LastName': 'Gutt', 'Affiliation': 'Department of General, Visceral, Thoracic and Vascular Surgery, Memmingen Hospital, Memmingen, Germany.'}, {'ForeName': 'Hubertus S', 'Initials': 'HS', 'LastName': 'Nottberg', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Evangelical Hospitals, Gelsenkirchen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pohl', 'Affiliation': 'Department of Surgery, Park Hospital Weissensee, Berlin, Germany.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Ghanem', 'Affiliation': 'Department of Visceral and Thoracic Surgery, Ingolstadt Hospital, Ingolstadt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Colorectal Cancer Center, Anregiomed Hospital Ansbach, Ansbach, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Imdahl', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, Heidenheim Rural District Hospitals gGmbH, Heidenheim, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Neudecker', 'Affiliation': 'Department of Surgery, Charité - University Medicine Berlin, Central Charité Campus and Virchow Hospital Campus, Berlin, Germany.'}, {'ForeName': 'Verena A', 'Initials': 'VA', 'LastName': 'Müller', 'Affiliation': 'Department of Surgery, Charité - University Medicine Berlin, Central Charité Campus and Virchow Hospital Campus, Berlin, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gehrig', 'Affiliation': 'Department of General and Visceral Surgery, Sinsheim Hospital, Sinsheim, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Reineke', 'Affiliation': 'Department of General and Visceral Surgery, Medius Hospital Nürtingen, Nürtingen, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'von Frankenberg', 'Affiliation': 'Department of Surgery, Salem Medical Center, Heidelberg, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Schumacher', 'Affiliation': 'Department of Surgery, Braunschweig Municipal Hospital gGmbH, Braunschweig, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Hennes', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Rossion', 'Affiliation': 'Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Klose', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Kieser', 'Affiliation': 'Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000003705']
611,31242512,Preventive Effects of Probiotic Supplementation on Neonatal Hyperbilirubinemia Caused by Isoimmunization.,"OBJECTIVE


Probiotic supplementation can help to improve recovery from jaundice by reducing enterohepatic circulation through the regulation of intestinal microbial flora. The aim of our study was to investigate the effect of probiotic supplementation on neonatal hyperbilirubinemia caused by isoimmunization alone.
STUDY DESIGN


Sixty neonates were randomly divided into a placebo group and a probiotic group ( Lactobacillus rhamnosus  GG). Serum total bilirubin (STB) levels were measured at birth and at 4, 8, 16, 24, and 36 hours of treatment (and at 48, 60, and 72 hours if necessary). Duration of phototherapy, rephototherapy requirements, and daily meconium evacuation were recorded.
RESULTS


STB and rebound STB levels at 36 hours were lower in the probiotic group than in the placebo group ( p  = 0.01 and  p  = 0.006, respectively). Meconium evacuation was more frequent in the probiotic group than in the placebo group on the second and third days of life ( p  = 0.002 and 0.009, respectively).
CONCLUSION


Probiotics do not affect STB levels in the first 24 hours of life or duration of phototherapy in neonates with jaundice caused by blood group incompatibility. The effect of probiotic supplementation by reducing enterohepatic circulation occurs at 36 hours of life in newborns with isoimmunization.",2020,"Meconium evacuation was more frequent in the probiotic group than in the placebo group on the second and third days of life ( p  = 0.002 and 0.009, respectively).
","['newborns with isoimmunization', 'Sixty neonates']","['placebo', 'Probiotic supplementation', 'probiotic supplementation', 'probiotic group ( Lactobacillus rhamnosus  GG', 'Probiotic Supplementation']","['neonatal hyperbilirubinemia', 'enterohepatic circulation', 'STB and rebound STB levels', 'Duration of phototherapy, rephototherapy requirements, and daily meconium evacuation', 'STB levels', 'Meconium evacuation', 'Serum total bilirubin (STB) levels', 'Neonatal Hyperbilirubinemia Caused by Isoimmunization']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0302020', 'cui_str': 'Isoimmunization (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0857007', 'cui_str': 'Hyperbilirubinemia, Neonatal'}, {'cui': 'C0014362', 'cui_str': 'Entero-Hepatic Circulation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0025047', 'cui_str': 'Meconium'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0302020', 'cui_str': 'Isoimmunization (finding)'}]",60.0,0.068279,"Meconium evacuation was more frequent in the probiotic group than in the placebo group on the second and third days of life ( p  = 0.002 and 0.009, respectively).
","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Mutlu', 'Affiliation': 'Department of Neonatology, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Yakup', 'Initials': 'Y', 'LastName': 'Aslan', 'Affiliation': 'Department of Neonatology, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Kader', 'Affiliation': 'Department of Neonatology, Karadeniz Technical University, Trabzon, Turkey.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Aktürk Acar', 'Affiliation': 'Department of Neonatology, Karadeniz Technical University, Trabzon, Turkey.'}]",American journal of perinatology,['10.1055/s-0039-1692690']
612,31219734,Treatment practices and lipid profile of patients with acute coronary syndrome: results from a tertiary care hospital.,"Background:  Considering the increasing burden of cardiovascular risk factors and recent advances on the management of acute coronary syndromes (ACS), we studied the epidemiological characteristics and treatment strategies of patients presenting with ACS. We also evaluated the lipid profile and attainment of lipid goals in a 'real world' clinical setting. Methods:  This was a substudy of IDEAL-LDL (Motivational interviewing to support low-density lipoprotein cholesterol (LDL-C) therapeutic goals and lipid-lowering therapy compliance in patients with acute coronary syndromes), a single-centre, prospective, randomised controlled trial. Baseline data from a total of 357 ACS patients were gathered using standardised methods. Results:  Median age of patients was 60 years and 81.2% were males. Arterial hypertension and smoking were the most prevalent risk factors for coronary artery disease (CAD). Patients with ST-elevation myocardial infarction (STEMI) were heavier smokers, but were younger and exercised more compared to those with non-ST-elevation acute coronary syndrome (NSTE-ACS). Conversely, more NSTE-ACS patients had arterial hypertension, dyslipidaemia and diabetes mellitus. One-fifth of ACS patients was treated conservatively without a percutaneous coronary intervention (PCI). A combination of statin, dual antiplatelet therapy and beta-blockers were prescribed to 79.6% of patients upon discharge. A renin-angiotensin-aldosterone system inhibitor and a beta-blocker were prescribed to 67.3 and 91.8% of patients with LVEF ≤40%, respectively. Of patients with prior history of CAD, 63.1%, 71.4% and 58.3% received regularly statins, antiplatelets and beta-blocker treatment, respectively. Only 22.3% of these CAD patients had an optimal LDL-C of <70 mg/dl at admission. Conclusions:  In hospitalised patients with ACS, management practices differed by ACS type and discharge medication was, mostly, in line with the latest guidelines. However, medication adherence and lipid lowering goals of secondary CAD prevention were largely unachieved.",2020,Only 22.3% of these CAD patients had an optimal LDL-C of <70 mg/dl at admission.  ,"['patients presenting with ACS', 'patients with acute coronary syndromes', 'Patients with ST-elevation myocardial infarction (STEMI) were heavier smokers', 'patients with acute coronary syndrome', 'hospitalised patients with ACS', 'Median age of patients was 60\xa0years and 81.2% were males', '357 ACS patients', 'acute coronary syndromes (ACS']","['percutaneous coronary intervention (PCI', 'statin, dual antiplatelet therapy and beta-blockers', 'LDL (Motivational interviewing to support low-density lipoprotein cholesterol (LDL-C) therapeutic goals and lipid-lowering therapy compliance']","['Arterial hypertension and smoking', 'ACS type and discharge medication', 'arterial hypertension, dyslipidaemia and diabetes mellitus', 'lipid profile and attainment of lipid goals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",357.0,0.0374371,Only 22.3% of these CAD patients had an optimal LDL-C of <70 mg/dl at admission.  ,"[{'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Farmakis', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Zafeiropoulos', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kartas', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aristi', 'Initials': 'A', 'LastName': 'Boulmpou', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Nevras', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Papadimitriou', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Tampaki', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Vlachou', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Markidis', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Koutsakis', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Ziakas', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Haralambos', 'Initials': 'H', 'LastName': 'Karvounis', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakoulas', 'Affiliation': 'Cardiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Acta cardiologica,['10.1080/00015385.2019.1626087']
613,31765315,The Effect of Optic Flow Speed on Active Participation During Robot-Assisted Treadmill Walking in Healthy Adults.,"This study aimed to investigate: 1) the effect of optic flow speed manipulation on active participation during robot-assisted treadmill walking (RATW), 2) the influence of the type of virtual environment, and 3) the level of motion sickness and enjoyment. Twenty-eight healthy older adults were randomized in two groups: ""stimulus rich"" Park group (50% male, 61± 6 year) and ""stimulus poor"" Hallway group (43% male, 62± 5 year). Subjects walked in the Lokomat with immersive virtual reality (VR) with a matched, slow and fast optic flow speed, each lasting 7 minutes. Active participation was measured by continuously assessing the human-machine interaction torques at the hip and knee joints and muscle activity of the Vastus Medialis and Biceps Femoris. Motion sickness and enjoyment were assessed with the Simulator Sickness Questionnaire (SSQ) and Physical Activity Enjoyment Scale (PACES) respectively. In both groups optic flow speed manipulation in both directions led to a decrease in bilateral hip interaction torques towards flexion at the end of the stance phase compared to matched speed. In the Hallway group, walking with slow optic flow elicited 32% more muscle activity of the Vastus Medialis. There were no significant differences between both groups for the SSQ and PACES. Optic flow speed manipulation appears to have only a small effect on the active participation of healthy people during RATW. The type of virtual environment did not affect their activity, motion sickness or enjoyment. However, the addition of immersive VR during RATW was well tolerated and enjoyable. Further research with patients is necessary.",2020,"In the Hallway group, walking with slow optic flow elicited 32% more muscle activity of the Vastus Medialis.","['Healthy Adults', 'Twenty-eight healthy older adults']","['stimulus poor"" Hallway', 'Optic Flow Speed', 'Lokomat with immersive virtual reality (VR', 'Robot-Assisted Treadmill Walking', 'stimulus rich"" Park', 'optic flow speed manipulation']","['muscle activity of the Vastus Medialis', 'Simulator Sickness Questionnaire (SSQ) and Physical Activity Enjoyment Scale (PACES', 'tolerated and enjoyable', 'Motion sickness and enjoyment', 'activity, motion sickness or enjoyment', 'Active participation', 'bilateral hip interaction torques towards flexion']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0562499', 'cui_str': 'Hallway (environment)'}, {'cui': 'C2936245', 'cui_str': 'Optic Flow'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0026603', 'cui_str': 'Motion Sickness'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]",28.0,0.029027,"In the Hallway group, walking with slow optic flow elicited 32% more muscle activity of the Vastus Medialis.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'De Keersmaecker', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lefeber', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Serrien', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Jansen', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodriguez-Guerrero', 'Affiliation': ''}, {'ForeName': 'Nilofar', 'Initials': 'N', 'LastName': 'Niazi', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kerckhofs', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Swinnen', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2955804']
614,31238785,Effectiveness of a Student Pharmacist-Led Telephone Follow-Up Intervention to Improve Hemoglobin A 1C  in Diabetic Patients.,"OBJECTIVE


To evaluate the effectiveness of a student pharmacist-led telephone follow-up intervention to improve hemoglobin A 1c  (HbA 1c ) in diabetic patients.
METHODS


This was a prospective, randomized, pilot study to implement a telephone follow-up intervention for diabetic patients with HbA 1c  ≥7%. Patients were recruited and randomized into intervention and control groups. All patients received standard of care. Patients in the intervention group additionally received weekly phone calls from a student pharmacist for 12 weeks to encourage medication adherence. HbA 1c  at baseline and end of study were measured and the data were analyzed using SAS version 9.4. Analysis included descriptive statistics and a multiple regression model to assess the association between the end of study and baseline HbA 1c  while controlling for demographics.
RESULTS


Seventy-eight patients participated and the average age was 62 (±11) years. Baseline HbA 1c  was 8.2% (±1.4%) in the intervention group and 7.9% (±1.3%) in the control group. HbA 1c  decreased by 0.35% in the intervention group ( P  = .027) and increased by 0.338% in the control group ( P  = .013). The end of study HbA 1c  were higher in the control group even after controlling for baseline HbA 1c s (0.5547,  P  value .002) in the regression model.
CONCLUSION


Incorporating student pharmacists in physician offices to provide clinical care services could lead to improved patient outcomes and students' clinical and research skills.",2020,HbA 1c  decreased by 0.35% in the intervention group ( P  = .027) and increased by 0.338% in the control group ( P  = .013).,"['Seventy-eight patients participated and the average age was 62 (±11) years', 'diabetic patients with HbA 1c  ≥7', 'Diabetic Patients', 'diabetic patients']","['Student Pharmacist-Led Telephone Follow-Up Intervention', 'student pharmacist-led telephone follow-up intervention', 'telephone follow-up intervention', 'weekly phone calls from a student pharmacist']","['HbA 1c', 'Hemoglobin', 'hemoglobin']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",78.0,0.0206995,HbA 1c  decreased by 0.35% in the intervention group ( P  = .027) and increased by 0.338% in the control group ( P  = .013).,"[{'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Peasah', 'Affiliation': '15473Mercer University College of Pharmacy, Atlanta, GA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Granitz', 'Affiliation': '15473Mercer University College of Pharmacy, Atlanta, GA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Vu', 'Affiliation': '15473Mercer University College of Pharmacy, Atlanta, GA, USA.'}, {'ForeName': 'Bobby', 'Initials': 'B', 'LastName': 'Jacob', 'Affiliation': '15473Mercer University College of Pharmacy, Atlanta, GA, USA.'}]",Journal of pharmacy practice,['10.1177/0897190019857409']
615,31228197,Promoting Volunteering Among Older Adults in Hong Kong: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Volunteering has consistently been associated with better mental, physical, and cognitive health in older adulthood. However, the volunteering rate of older adults in Hong Kong is much lower than in Western countries. Few studies have examined whether interventions can be effective in motivating older adults to volunteer in Hong Kong. To fill this gap, we conducted a randomized controlled trial to examine the impact of a theory-based social-cognitive intervention on volunteering.
RESEARCH DESIGN AND METHODS


A total of 264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage = 6.90 years, 81.06% female) were randomly assigned to either an experimental group or an active control group. Participants in the experimental group received 4 weekly 1-hr face-to-face volunteering intervention sessions. Those in the active control group received parallel sessions targeting physical activity instead of volunteering. The time spent on volunteering per month was self-reported and measured at baseline, 6 weeks, 3 months, and 6 months after the intervention. Self-efficacy, intention, action planning, and self-monitoring of volunteering were measured as mediators.
RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups. Self-efficacy, intention, and action planning consistently mediated the effect of the intervention on volunteering minutes.
DISCUSSION AND IMPLICATIONS


The findings demonstrate the effectiveness of the intervention on volunteering behavior in older adults in Hong Kong through well-established behavior change techniques.",2020,"RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups.","['older adulthood', 'Older Adults in Hong Kong', 'motivating older adults to volunteer in Hong Kong', '6.90 years, 81.06% female', '264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage ', 'older adults']","['active control group', 'parallel sessions targeting physical activity instead of volunteering', 'theory-based social-cognitive intervention', '4 weekly 1-hr face-to-face volunteering intervention sessions']","['Self-efficacy, intention, action planning, and self-monitoring of volunteering', 'volunteering behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",264.0,0.0563992,"RESULTS


Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups.","[{'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Warner', 'Affiliation': 'Department of Psychology, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Alice Ming-Lin', 'Initials': 'AM', 'LastName': 'Chong', 'Affiliation': 'Department of Social and Behavioural Sciences, City University of Hong Kong, Kowloon Tong, Hong Kong, China.'}, {'ForeName': 'Tianyuan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Centre for Psychosocial Health, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Wolff', 'Affiliation': 'Department of Psychology, Friedrich-Alexander-University (FAU) Erlangen-Nuremberg, Institute of Psychogerontology, Nuremberg, Germany.'}, {'ForeName': 'Kee-Lee', 'Initials': 'KL', 'LastName': 'Chou', 'Affiliation': 'Department of Asian and Policy Studies, The Education University of Hong Kong, Tai Po, Hong Kong, China.'}]",The Gerontologist,['10.1093/geront/gnz076']
616,31240515,Effect of Spiritual Care Based on Ghalbe Salim on Anxiety in Adolescent with Cancer.,"Cancer is one of the chronic and rare diseases in children that is associated with psychological trauma that can cause fear and anxiety in patients. Considering that spirituality as a solid base may be a strong factor in controlling the tense conditions, this study aimed to investigate the effect of true heart spiritual care on cancer anxiety in Mashhad. This is a case-control study on 40 children referred to Dr. Sheikh Mashhad Children's Therapeutic Center in 2017. Sampling was done randomly in two groups of test and control. The experimental group received the training program in five sessions in 4 weeks. The data were collected using a demographic questionnaire and Marx children's anxiety scale and entered into spssv.20 software. There was no difference the score of anxiety before intervention in any of the dimensions of anxiety and the general dimension of anxiety in the case and control (P < 0.01). However, the mean of anxiety score in the SC group before and after intervention was significantly (75.25 ± 15.2) (44.55 ± 7.62), respectively. So that 50% of the posttest changes are due to the effect of the intervention. Regarding the effect of SC on reducing cancer anxiety, it is recommended that therapists, counselors and clinical psychologists use the spiritual care education method to reduce anxiety.",2020,There was no difference the score of anxiety before intervention in any of the dimensions of anxiety and the general dimension of anxiety in the case and control (P < 0.01).,"[""40 children referred to Dr. Sheikh Mashhad Children's Therapeutic Center in 2017"", 'Adolescent with Cancer']","['Spiritual Care Based on Ghalbe Salim', 'training program', 'SC']","['mean of anxiety score', 'cancer anxiety', 'anxiety and the general dimension of anxiety', ""demographic questionnaire and Marx children's anxiety scale"", 'score of anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0222045'}]",40.0,0.0233423,There was no difference the score of anxiety before intervention in any of the dimensions of anxiety and the general dimension of anxiety in the case and control (P < 0.01).,"[{'ForeName': 'Mozhdeh', 'Initials': 'M', 'LastName': 'Vazifeh Doust', 'Affiliation': 'Department of Nursing, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Hojjati', 'Affiliation': 'Department of Nursing, Aliabad Katoul Branch, Islamic Azad University, Aliabad Katoul, Iran. Hojjati_hamid2019@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Farhangi', 'Affiliation': 'Department of Pediatric Diseases, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of religion and health,['10.1007/s10943-019-00869-9']
617,31796519,A Phase II Trial of Pembrolizumab and Vorinostat in Recurrent Metastatic Head and Neck Squamous Cell Carcinomas and Salivary Gland Cancer.,"PURPOSE


This clinical trial combined pembrolizumab and vorinostat in recurrent/metastatic squamous cell carcinomas of the head and neck (HN), and salivary gland cancer (SGC).
PATIENTS AND METHODS


Patients with progressing incurable HN and SGC, Eastern Cooperative Oncology Group (ECOG) ≤1, no prior immunotherapy, RECIST1.1 measurable disease, and normal organ function were eligible. Pembrolizumab 200 mg was given intravenous every 21 days, and vorinostat 400 mg given orally 5 days on and 2 days off during each 21-day cycle. Primary endpoints were safety and objective response rates.
RESULTS


From November 2015 to August 2017, 25 patients with HN and 25 SGC were enrolled. Median age was 61 (range, 33-86) years, 39 (78%) were male, 21 (62%) were never smokers, and 27 (54%) had ECOG 0. In HN, 13 (52%) were p16+ oropharynx. Most common SGC histologies were adenoid cystic 12 (48%), acinic cell 3 (12%), and mucoepidermoid 3 (12%). Adverse events (AEs) in all patients were: 27 (54%) with grade ≥ 1 and 18 (36%) with grade ≥ 3. The most common AEs in all patients were renal insufficiency in seven, (14%), fatigue in six, (12%), and nausea in three (6%). There were three (12%) deaths on study. Responses in HN were complete response (CR) 0, partial response (PR) eight (32%), and stable disease (SD) five (20%). Efficacy in SGCs was CR 0, PR four (16%) in one lymphoepithelioma-like carcinoma, two acinic cell, one adenoid cystic, and SD 14 (56%). In the HN group, median follow-up (mFUP) was 12.6 months, median overall survival (mOS) was 12.6 months, and median progression-free survival (mPFS) was 4.5 months. In SGC, mFUP was 13.1 months, mOS was 14.0 months, and mPFS was 6.9 months.
CONCLUSIONS


This combination demonstrated activity in HN, with fewer responses in SGC. Toxicities were higher than reported with pembrolizumab alone.",2020,"In the HN group, median follow up(mFUP) was 12.6 months, median overall survival(mOS) was 12.6 months, and median progression free survival (mPFS) was 4.5 months.","['recurrent metastatic head and neck squamous cell carcinomas and salivary gland cancer', 'recurrent/metastatic squamous cell carcinomas of the head and neck(HN), and salivary gland cancer(SGC', 'From 11/2015 to 8/2017, 25 HN and 25 SGC pts were enrolled', 'Patients with progressing incurable HN and SGC ECOG ≤1, no prior immunotherapy, RECIST1.1 measurable disease, normal organ function were eligible', 'Median age was 61(range 33-86) yrs, 39(78%) were male, 21(62%) were never smokers, 27(54%) had ECOG 0']","['pembrolizumab and vorinostat', 'pembrolizumab', 'Pembrolizumab']","['median follow up(mFUP', 'median progression free survival (mPFS', 'median overall survival(mOS', 'Toxicities', 'safety and objective response rates', 'acinic cell(AciC']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0220636', 'cui_str': 'Cancer of Salivary Gland'}, {'cui': 'C0036098', 'cui_str': 'Salivary Glands'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.0542156,"In the HN group, median follow up(mFUP) was 12.6 months, median overall survival(mOS) was 12.6 months, and median progression free survival (mPFS) was 4.5 months.","[{'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington. rodrigcr@uw.edu.'}, {'ForeName': 'Qian Vicky', 'Initials': 'QV', 'LastName': 'Wu', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Voutsinas', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Fromm', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Xiuyun', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, Washington.'}, {'ForeName': 'Venu G', 'Initials': 'VG', 'LastName': 'Pillarisetty', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, Washington.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Santana-Davila', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Goulart', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Baik', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Laura Q M', 'Initials': 'LQM', 'LastName': 'Chow', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Eaton', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Martins', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, Washington.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2214']
618,31220957,Effect of empiric intravenous intralipid therapy on pregnancy outcome in women with unexplained recurrent implantation failure undergoing intracytoplasmic sperm injection-embryo transfer cycle: a randomized controlled trial.,"To evaluate the effect of empiric intralipid infusion therapy on pregnancy outcomes for patients with unexplained recurrent implantation failure (RIF) undergoing intracytoplasmic sperm injection (ICSI). A total of 142 patients with a history of unexplained RIF (3 or more cycles) were included in this randomized controlled trial. Patients were randomized into two groups, study group ( n  = 71) and control group ( n  = 71). The study group received intralipid 20% infusion on the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The clinical pregnancy rate in the study group was 36.6% ( n  = 26) compared to 28.2% ( n  = 20) in the control group (OR 1.47, CI 0.72-2.98,  p  = .282). The live birth rate in the study group was 18.3% ( n  = 13) and 14.1% ( n  = 10) in the control group (OR 1.37, CI 0.55-3.36,  p =.49). No side effects of intralipid therapy were reported in the study period. There was improvement in the pregnancy rate among women with unexplained RIF who received empiric intralipid infusion therapy; however, this improvement did not reach statistical significance.",2020,"The clinical pregnancy rate in the study group was 36.6% ( n  = 26) compared to 28.2% ( n  = 20) in the control group (OR 1.47, CI 0.72-2.98,  p  = .282).","['patients with unexplained recurrent implantation failure (RIF) undergoing intracytoplasmic sperm injection (ICSI', '142 patients with a history of unexplained RIF (3 or more cycles', 'women with unexplained recurrent implantation failure undergoing intracytoplasmic sperm injection-embryo transfer cycle']","['empiric intralipid infusion therapy', 'intralipid 20% infusion on the day of embryo transfer (ET', 'empiric intravenous intralipid therapy', 'intralipid therapy']","['pregnancy outcome', 'pregnancy rate', 'live birth rate', 'clinical pregnancy rate', 'pregnancy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0733854', 'cui_str': 'Intralipid'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",142.0,0.171864,"The clinical pregnancy rate in the study group was 36.6% ( n  = 26) compared to 28.2% ( n  = 20) in the control group (OR 1.47, CI 0.72-2.98,  p  = .282).","[{'ForeName': 'Jawharah', 'Initials': 'J', 'LastName': 'Al-Zebeidi', 'Affiliation': 'Reproductive Endocrine and Infertility Medicine Department, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Agdi', 'Affiliation': 'Reproductive Medicine, Bnoon Medical Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Lary', 'Affiliation': 'Reproductive Endocrine and Infertility Medicine Department, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Solaiman', 'Initials': 'S', 'LastName': 'Al-Obaid', 'Affiliation': 'Reproductive Endocrine and Infertility Medicine Department, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Gamar', 'Initials': 'G', 'LastName': 'Salim', 'Affiliation': 'Reproductive Endocrine and Infertility Medicine Department, King Fahad Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Dania', 'Initials': 'D', 'LastName': 'Al-Jaroudi', 'Affiliation': 'Reproductive Endocrine and Infertility Medicine Department, King Fahad Medical City, Riyadh, Saudi Arabia.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1631280']
619,31211324,Digoxin-mortality: randomized vs. observational comparison in the DIG trial.,"AIMS


The Digitalis Investigation Group (DIG) trial, the only large randomized trial of digoxin in heart failure, reported a neutral effect on mortality and a significant reduction in heart failure hospitalizations. Recent observational studies reported increased mortality with digoxin treatment. We present further analyses of the DIG trial displaying the inability to control bias in observational treatment comparisons despite extensive statistical adjustments.
METHODS AND RESULTS


Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment. We contrast the main randomization-based result of the DIG trial with the observational non-randomized comparison of patients pre-treated or not pre-treated with digoxin. Mortality [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.12-1.34; P < 0.001] and heart failure hospitalizations (HR 1.47, 95% CI 1.33-1.61; P < 0.001) were significantly higher in patients pre-treated with digoxin even after adjustment for baseline population differences. The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001). This sharply contradicts the neutral effect on mortality and the significant reduction in heart failure hospitalizations observed in the randomized comparison.
CONCLUSION


Prescription of digoxin is an indicator of disease severity and worse prognosis, which cannot be fully accounted for by covariate adjustments in the DIG trial where patients were well-characterized. It is unlikely that weaker research approaches (observational studies of administrative data or registries) can provide more reliable estimates of the effects of cardiac glycosides.",2019,"The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001).","['Forty-four percent of the 6800 patients in the DIG trial had been treated with digoxin before randomization, and half of them were randomly withdrawn from digoxin treatment']","['digoxin', 'placebo']","['Mortality [hazard ratio (HR', 'Digoxin-mortality', 'heart failure hospitalizations']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3181833', 'cui_str': 'Dig(dhd)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",6800.0,0.436592,"The higher risks for both outcomes in those who had previously received digoxin persisted even if they received placebo during the trial (HR 1.24, 95% CI 1.10-1.40; P < 0.001).","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Aguirre Dávila', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bavendiek', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC, USA.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.'}]",European heart journal,['10.1093/eurheartj/ehz395']
620,31772102,Safety and efficacy of tranexamic acid in paediatric cardiac surgery: study protocol for a double-blind randomised controlled trial.,"INTRODUCTION


An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery.
METHODS AND ANALYSIS


This will be a single-centre prospective, double-blind randomised controlled trial. The plan is to enrol in the study 2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB). All eligible participants will be randomly assigned to either the TXA or placebo group by using a Web-based randomisation service in a 1:1 ratio. The primary safety end point will be postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB. All patients will be followed up for 1 year postdischarge. All data will be analysed in accordance with the intention-to-treat principle.
ETHICS AND DISSEMINATION


This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Register (ChiCTR1900024131).",2019,An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery.,"['2090 paediatric patients aged 31 days to 7 years who will be undergoing cardiac surgery with cardiopulmonary bypass (CPB', 'Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College ', 'paediatric cardiac surgery', 'paediatric patients undergoing cardiac surgery']","['tranexamic acid', 'tranexamic acid (TXA', 'TXA', 'TXA or placebo']","['efficacy and safety', 'Safety and efficacy', 'postoperative seizures until hospital discharge, and the primary efficacy end point will be the volume of allogeneic red blood cell transfusion after termination of CPB', 'postoperative allogeneic transfusion', 'incidence of seizures']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2090.0,0.613172,An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Paediatric Intensive Care Unit, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Cardiopulmonary Bypass, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ran', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongdong', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shoujun', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shengshou', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Cardiovascular Surgery, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Centre, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yanfuxiafw@sina.com wangyfuwai@sohu.com.'}, {'ForeName': 'Fuxia', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Anaesthesiology, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China yanfuxiafw@sina.com wangyfuwai@sohu.com.'}]",BMJ open,['10.1136/bmjopen-2019-032642']
621,31789492,"Clinical assessment of tolerability, immunological and cutaneous reactivity effects of an abbreviated schedule with Olea europaeanative extract of subcutaneous immunotherapy.","Summary


Objectives. To evaluate the tolerability and efficacy of Olea europaea subcutaneous immunotherapy (SCIT) on patients with rhinoconjunctivitis. Methods. In this open clinical trial patients were assigned to an abbreviated build-up scheme. The outcomes were: number, percentage, and severity of adverse reactions. Secondary outcomes included: changes in immunoglobulin titers and changes in dose-response skin prick tests. Results. Only 8 systemic reactions were registered, which represented 7/47 (14.9%) of patients and 8/429 (1.9%) of administered doses. Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system. Cutaneous reactivity decreased significantly. Conclusions. Olea europaea SCIT (Allergovac® depot ROXALL Medicina España S.A.) showed a good safety and tolerability profile. Immunological changes with induction of blocking IgG and decreases in cutaneous reactivity were detected in the patients.",2020,Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system.,['patients with rhinoconjunctivitis'],"['subcutaneous immunotherapy', 'Olea europaea subcutaneous immunotherapy (SCIT']","['cutaneous reactivity', 'number, percentage, and severity of adverse reactions', 'sIgG and sIgG4', 'changes in immunoglobulin titers and changes in dose-response skin prick tests', 'Cutaneous reactivity', 'Olea europaea SCIT ', 'tolerability and efficacy', 'tolerability, immunological and cutaneous reactivity effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}]","[{'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy (procedure)'}, {'cui': 'C1122969', 'cui_str': 'Olea europaea'}]","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C1122969', 'cui_str': 'Olea europaea'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0435717,Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Saenza De San Pedro', 'Affiliation': 'Hospital Universitario de Jaén. Allergology Department, Jaén, Spain.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Mur', 'Affiliation': 'Hospital Santa Bárbara. Allergology Department, Puertollano, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Valverde', 'Affiliation': 'Hospital Costa de la Luz de Huelva. Allergology Department, Huelva, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gonzalo Garijo', 'Affiliation': 'Hospital Universitario Infanta Cristina. Allergology Department, Badajoz, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Hospital Nisa. Allergology Department, Seville, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Madariaga', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Asturias', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Begona', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gomez Fernandez', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}]",European annals of allergy and clinical immunology,['10.23822/EurAnnACI.1764-1489.124']
622,31785587,Kinetics of oxytocin effects on amygdala and striatal reactivity vary between women and men.,"Accumulating evidence suggests that intranasal oxytocin (OXT; 24 IU) reduces amygdala responses to fear-related stimuli in men, while exerting inverse effects in women. However, OXT enhances activity of the brain reward system in both sexes. Importantly, a crucial and still open question is whether there are sex-specific dose-response relationships for the amygdala and striatal regions. To address this question, a total of 90 healthy women participated in a double-blind, placebo-controlled crossover functional magnetic resonance imaging (fMRI) study and the results were compared with our previous findings from men. Participants were randomly assigned to three doses of OXT (6 IU, 12 IU, and 24 IU) and completed an emotional face recognition task including fearful and happy faces of varying emotional intensities. Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women. While treatment effects on amygdala reactivity were evident at each given dose, the OXT effect on striatal responses to social stimuli was more pronounced with higher doses, but this dose-dependent effect did not survive correction for multiple comparisons. Importantly, OXT effects on amygdala and striatal activation significantly differed between sexes and striatal baseline sexual-dimorphic response patterns were diminished after administration of OXT. Our findings suggest that OXT increases the salience of social signals by strengthening the sensitivity for these signals in the amygdala and in the striatum in women, while OXT may primarily induce anxiolysis by reducing amygdala responses in men.",2020,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","['90 healthy women participated in a double-blind', 'women and men']","['OXT', 'placebo-controlled crossover functional magnetic resonance imaging (fMRI', 'oxytocin', 'intranasal oxytocin (OXT', 'placebo', 'emotional face recognition task including fearful and happy faces of varying emotional intensities']","['amygdala reactivity', 'amygdala and striatal reactivity', 'OXT effects on amygdala and striatal activation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",90.0,0.234159,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lieberz', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany. Dirk-Scheele@gmx.de.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Institute for Psychology, University of Freiburg, 79104, Freiburg, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Matheisen', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Lìa', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kinfe', 'Affiliation': 'Department of Neurosurgery, Division of Functional Neurosurgery and Stereotaxy, Friedrich-Alexander University (FAU) Erlangen-Nürnberg, 91054, Erlangen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0582-6']
623,31272568,Characterization of the Obese Phenotype of Heart Failure With Preserved Ejection Fraction: A RELAX Trial Ancillary Study.,"OBJECTIVE


To characterize the obese heart failure with preserved ejection fraction (HFpEF) phenotype in a multicenter cohort.
PATIENTS AND METHODS


This was a secondary analysis of the randomized clinical trial RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Heart Failure with Preserved Ejection Fraction) performed between October 1, 2008, and February 1, 2012. Patients with HFpEF were classified by body mass index (BMI) as obese (BMI≥35 kg/m 2 ) and nonobese (BMI<30 kg/m 2 ) for comparison.
RESULTS


Obese patients with HFpEF (n=81) were younger (median age, 64 [interquartile range (IQR), 67-79] years vs 73 [IQR, 56-70] years; P<.001) but had greater peripheral edema (31% [25] vs 9% [6]; P<.001), more orthopnea (76% [56] vs 53% [35]; P=.005), worse New York Heart Association class (P=.006), and more impaired quality of life (P<.001) as compared with nonobese patients with HFpEF (n=70). Despite more severe signs and symptoms, obese patients with HFpEF had lower N-terminal pro B-type natriuretic peptide level (median, 481 [IQR, 176-1183] pg/mL vs 825 [IQR, 380-1679] pg/mL [to convert to pmol/L, multiply by 0.118]; P=.007) and lower left atrial volume index (median, 38 [IQR, 31-47] mL/m 2  vs 54 [IQR, 41-63] mL/m 2 ; P<.001). Serum C-reactive protein (median, 5.0 [IQR, 2.4-9.9] mg/dL vs 2.7 [IQR, 1.6-5.4] mg/dL [to convert to mg/L, multiply by 10 -3 ]; P<.001) and uric acid (median, 7.8 [IQR, 6.1-8.7] mg/dL vs 6.8 [IQR, 5.5-8.3] mg/dL; P=.03) levels were higher in obese HFpEF, indicating greater systemic inflammation, than in nonobese HFpEF. Peak oxygen consumption was impaired in obese HFpEF (median, 11.1 [IQR, 9.6-14.4] mL/kg per minute vs 13.1 [IQR, 11.3-14.7] mL/kg per minute; P=.008), as was submaximal exercise capacity (6-minute walk distance, 272 [IQR, 200-332] m vs 355 [IQR, 290-415] m; P<.0001).
CONCLUSION


Obese HFpEF is associated with decreased quality of life, worse symptoms of heart failure, greater systemic inflammation, worse exercise capacity, and higher metabolic cost of exertion as compared with nonobese HFpEF. Further study is required to understand the pathophysiology and potential distinct treatments for patients with the obese phenotype of HFpEF.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00763867.",2019,"; P=.03) levels were higher in obese HFpEF, indicating greater systemic inflammation, than in nonobese HFpEF.","['Obese Phenotype of Heart Failure', 'Heart Failure with Preserved Ejection Fraction) performed between October 1, 2008, and February 1, 2012', 'Patients with HFpEF were classified by body mass index (BMI) as obese (BMI≥35 kg/m 2 ) and nonobese (BMI<30 kg/m 2 ) for comparison', 'patients with the obese phenotype of HFpEF', 'nonobese patients with HFpEF (n=70', 'Obese patients with HFpEF (n=81']","['dL', 'Preserved Ejection Fraction', 'RELAX (Phosphodiesterase-5 Inhibition']","['peripheral edema', 'lower N-terminal pro B-type natriuretic peptide level', 'uric acid', 'orthopnea', 'submaximal exercise capacity', 'systemic inflammation', 'quality of life', 'left atrial volume index', 'Serum C-reactive protein', 'Peak oxygen consumption', 'quality of life, worse symptoms of heart failure, greater systemic inflammation, worse exercise capacity, and higher metabolic cost of exertion']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase Type 5'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0085619', 'cui_str': 'Orthopnea (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0034380'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",81.0,0.329009,"; P=.03) levels were higher in obese HFpEF, indicating greater systemic inflammation, than in nonobese HFpEF.","[{'ForeName': 'Yogesh N V', 'Initials': 'YNV', 'LastName': 'Reddy', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Division of Cardiology, Northwestern University, Chicago, IL.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Obokata', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Omar F', 'Initials': 'OF', 'LastName': 'Abou-Ezzedine', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Division of Cardiology, Duke University, Durham, NC.'}, {'ForeName': 'Jie-Lena', 'Initials': 'JL', 'LastName': 'Sun', 'Affiliation': 'Division of Cardiology, Duke University, Durham, NC.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Division of Cardiology, Duke University, Durham, NC.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': 'Division of Cardiology, Duke University, Durham, NC.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'LeWinter', 'Affiliation': 'Division of Cardiology, University of Vermont, Burlington.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Division of Cardiology, Washington University, St. Louis, MO.'}, {'ForeName': 'Lynne W', 'Initials': 'LW', 'LastName': 'Stevenson', 'Affiliation': 'Division of Cardiology, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address: borlaug.barry@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2018.11.037']
624,31738072,Improvement in women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder.,"The cardiovascular system is disrupted by chronic excessive alcohol use and often impaired in individuals with an alcohol use disorder (AUD). Less is known about cardiovascular recovery when an individual receives treatment for AUD. This observational study aimed to extend the growing body of evidence for cardiovascular biomarkers and intervention targets in the treatment of AUD. We examined cardiovascular function in 92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD. Participants were recruited exclusively from a randomized clinical trial comparing group versus individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available. Demographic and drinking data were obtained from the parent study. Cardiovascular data were collected as part of this separate study, prior to and following the clinical trial. Mixed-model analyses revealed multiple within-person cardiovascular changes indicative of improving health from pre- to posttreatment, including reduced heart rate and vessel stiffness as well as increased heart rate variability and baroreflex sensitivity. These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions. Future studies should assess the time course of cardiovascular recovery during addiction treatment and the mechanisms by which evidence-based AUD treatments may benefit physical as well as mental health. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","['individuals with an alcohol use disorder (AUD', ""women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder"", '92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD']","['individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available']","['heart rate variability and baroreflex sensitivity', 'heart rate and vessel stiffness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",2019.0,0.0455963,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Lesnewich', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000524']
625,31782167,Effectiveness of a modified comprehensive behavioral intervention for tics for children and adolescents with tourette's syndrome: A randomized controlled trial.,"AIM


To evaluate the effectiveness of a modified four-session Comprehensive Behavioral Intervention for Tics programme for decreasing tics in children and adolescents with Tourette's syndrome.
BACKGROUND


Comprehensive Behavioral Intervention for Tics programme has been shown to decrease tic severity. However, the lack of behaviour therapists in countries, such as in Taiwan, may preclude application of the standard eight-session, 10-week programme.
DESIGN


Randomized controlled study.
METHODS


Participants aged 6-18 years diagnosed with Tourette's syndrome or chronic tic disorder were recruited from February 2015 through September 2016. Participants in the control and intervention groups (N = 23 each) received the routine care (daily pyridoxine [50 mg] and psychoeducation). The intervention group received additional four behavioural intervention sessions over a 3-month period that included psychoeducation, habit reversal training, relaxation training, and education on tic relapse prevention. The outcome measures, Yale Global Tic Severity Scale scores, were assessed at before and after the completion of programme for both groups and again at 3 months follow-up for the intervention group. The effect of the intervention on severity scores was assessed using a generalized estimated equation.
RESULTS


Comparison of scores before and after intervention showed that the intervention significantly decreased the severity of total motor tics (B = -3.28, p < .01) and total tics (B = -5.86, p < .01) as compared with control treatment. YGTSS scores for the intervention group were lower at 3-month follow-up as compared with before treatment or immediately after treatment completion (total tics, p < .001).
CONCLUSION


The modified four-session Comprehensive Behavioral Intervention for Tics programme was more effective than routine care for decreasing tic severity in our cohort of 6- to 18-year olds. This improvement was maintained 3 months after intervention.
IMPACT


Healthcare providers, including nurses, in countries currently not adopting Comprehensive Behavioral Intervention for Tics programme should be made aware of the positive effects of this modified intervention for Tourette's syndrome.",2020,"YGTSS scores for the intervention group were lower at 3 months follow-up as compared with before treatment or immediately after treatment completion (total tics, p < .001).
","[""children and adolescents with Tourette's syndrome"", ""Children and Adolescents with Tourette's Syndrome"", ""Participants aged 6-18\xa0years diagnosed with Tourette's syndrome or chronic tic disorder were recruited from February 2015 through September 2016""]","['Modified Comprehensive Behavioral Intervention', 'routine care (daily pyridoxine [50\xa0mg] and psychoeducation', 'additional four behavioral intervention sessions over a 3-month period that included psychoeducation, habit-reversal training, relaxation training and education on tic relapse prevention', 'modified 4-session Comprehensive Behavioral Intervention']","['total tics', 'Yale Global Tic Severity Scale scores', 'severity of total motor tics', 'severity scores', 'YGTSS scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040517', 'cui_str': 'Chronic Motor and Vocal Tic Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008701', 'cui_str': 'Chronic Motor or Vocal Tic Disorder'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0751900', 'cui_str': 'Tic, Motor'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",,0.0741417,"YGTSS scores for the intervention group were lower at 3 months follow-up as compared with before treatment or immediately after treatment completion (total tics, p < .001).
","[{'ForeName': 'Chia-Wen', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, College of nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Huei-Shyong', 'Initials': 'HS', 'LastName': 'Wang', 'Affiliation': ""Division of Pediatric Neurology, Chang Gung Children's Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.""}, {'ForeName': 'Hsiu-Ju', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, College of nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chang-Wei', 'Initials': 'CW', 'LastName': 'Hsueh', 'Affiliation': 'Division of Pediatric Neurology, Landseed International Hospital, Taoyuan, Taiwan.'}]",Journal of advanced nursing,['10.1111/jan.14279']
626,31683023,Modified Biofeedback (Conditioned Biofeedback) Promotes Antinociception by Increasing the Nociceptive Flexion Reflex Threshold and Reducing Temporal Summation of Pain: A Controlled Trial.,"This study examined whether a modified version of biofeedback (ie, Conditioned Biofeedback) that incorporated placebo analgesia-like manipulations could promote antinociception in healthy, pain-free participants. During Conditioned Biofeedback (n = 28), sympathetic arousal level was displayed visually and participants were asked to reduce it while they received painful electric stimulations that were surreptitiously controlled by their arousal level. Thus, electric pain decreased as arousal decreased to associate successful arousal-reduction/relaxation with pain relief, and to promote expectations for future pain relief. A Biofeedback Only group (n = 24) controlled for the general effects of biofeedback/relaxation. A Biofeedback+Shock group (n = 21) controlled for the effects of practicing biofeedback during painful shocks. Nociceptive flexion reflex (NFR) threshold and temporal summation of pain (TS-pain) were used to assess changes in spinal nociception and pain facilitation, respectively. Results indicated all groups showed pre- to postbiofeedback increases in NFR threshold, but only the Conditioned Biofeedback group showed pre- to postbiofeedback reductions in TS-pain. Moreover, Conditioned Biofeedback resulted in a persistent (prebiofeedback) increase in NFR threshold across sessions, whereas Biofeedback Only resulted in a persistent (prebiofeedback) decrease in TS-pain. In sum, Conditioned Biofeedback may promote antinociception in healthy participants thus reducing risk for chronic pain. The study was registered prospectively on ClinicalTrials.gov (TU1560). PERSPECTIVE: A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers. As a result, it may be an effective means of reducing risk of future chronic pain onset by promoting an antinociceptive pain profile.",2020,A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers.,"['healthy, pain-free participants', 'healthy participants', 'healthy volunteers']","['placebo analgesia-like manipulations', 'Conditioned Biofeedback', 'practicing biofeedback', 'placebo analgesia manipulations', 'biofeedback/relaxation', 'modified version of biofeedback (ie, Conditioned Biofeedback', 'Biofeedback+Shock', 'Modified biofeedback (Conditioned Biofeedback']","['pain facilitation', 'electric pain', 'spinal nociception and pain facilitation', 'sympathetic arousal level', 'temporal summation of pain', 'TS-pain', 'Nociceptive flexion reflex (NFR) threshold and temporal summation of pain (TS-pain', 'NFR threshold']","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1264664', 'cui_str': 'Number fraction'}]",,0.0847309,A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Rhudy', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma. Electronic address: jamie-rhudy@utulsa.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hellman', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Sturycz', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Toledo', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Shreela', 'Initials': 'S', 'LastName': 'Palit', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma; Pain Research and Intervention Center of Excellence, University of Florida, Gainesville, Florida.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.006']
627,31774544,"Comparative Pharmacokinetic Profiles of a Novel Low-dose Micronized-isotretinoin 32 mg Formulation and Lidose-isotretinoin 40 mg in Fed and Fasted Conditions: Two Open-label, Randomized, Crossover Studies in Healthy Adult Participants.","Two open-label, crossover studies compared the bioavailability of Micronized-isotretinoin 32 mg and Lidose-isotretinoin 40 mg in healthy adults. In the fed bioequivalence/food-effect study, participants (n = 71) received single doses of fed-state Micronized-isotretinoin 32 mg, fed-state Lidose-isotretinoin 40 mg and fasted-state Micronized-isotretinoin 32 mg. In the fasting study, participants (n = 18) received single doses of fasted-state Micronized-isotretinoin 32 mg and fasted-state Lidose-isotretinoin 40 mg. Bioavailability was assessed by isotretinoin LnAUC0–t, LnAUC0–∞ and LnCmax in blood samples taken pre-dosing and over 96 h post-dosing. The 90% confidence intervals for baseline-adjusted least squares geometric mean ratios for LnAUC0–t, LnAUC0–∞ and LnCmax fell within the 80–125% range for bioequivalence for fed-state Micronized-isotretinoin 32 mg vs. fed-state Lidose-isotretinoin 40 mg. Fasted-state Micronized-isotretinoin 32 mg had ~2 times higher bioavailability than fasted-state Lidose-isotretinoin 40 mg. Food had no effect on the rate  and a marginal effect on the extent of absorption of Micronized-isotretinoin 32 mg.",2020,Food had no effect on the rate and a marginal effect on the extent of absorption of micronized-isotretinoin 32 mg.,"['participants (n\u2009=\u200971) received', 'healthy adults', 'Healthy Adult Participants']","['single doses of fed-state micronized-isotretinoin 32 mg, fed-state', 'Lidose-isotretinoin 40 mg and fasted-state micronized-isotretinoin 32 mg', 'Fasted-state micronized-isotretinoin', 'fasted-state micronized-isotretinoin 32 mg and fasted-state Lidose-isotretinoin 40 mg', 'Novel Low-dose Micronized-isotretinoin 32 mg Formulation and Lidose-isotretinoin 40 mg in Fed and Fasted Conditions', 'micronized-isotretinoin 32 mg and Lidose-isotretinoin']","['Bioavailability', 'bioavailability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C3556573', 'cui_str': 'Isotretinoin 40 MG [Zenatane]'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.027466,Food had no effect on the rate and a marginal effect on the extent of absorption of micronized-isotretinoin 32 mg.,"[{'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Madan', 'Affiliation': 'Research and Development Centre, Sun Pharmaceutical Industries Ltd, Gurgaon, Haryana, India.'}, {'ForeName': 'Sudershan', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Jeanett', 'Initials': 'J', 'LastName': 'Segal', 'Affiliation': ''}]",Acta dermato-venereologica,['10.2340/00015555-3381']
628,31910451,Classical but Not Rap Music Significantly Improves Transferability and Long-Term Acquisition of Laparoscopic Suturing Skills: A Randomized Controlled Trial.,"INTRODUCTION


Acoustic distractions have been shown to increase the level of stress and workload in the operating room (OR). Noise significantly reduces surgical performance, but experienced surgeons are able to reduce the acoustic perception of their surroundings to maintain a high level of performance in complex surgical tasks. However, music has been shown to improve learning and performance of complex motor skills. The aim of this study was to evaluate the influence of music on transferability and long-term acquisition of laparoscopic suturing skills.
MATERIALS AND METHODS


To evaluate the effects of music on training, subjects were asked to perform four surgeon's square knots on a bowel model within 30 minutes-prior and post 3 hours of hands-on training. To examine long-term skills, the same students were asked to perform a comparable, but more complex, task (four slip knots in a model of esophageal atresia) 6 months post initial training, as a follow-up measurement. Total time, knot stability (evaluated via tensiometer), suture accuracy, knot quality (Muresan scale), and laparoscopic performance (Munz checklist) were assessed.
RESULTS


Twenty-four students were included in the study; after simple randomization, 16 were trained while exposed to music (eight to Bach and eight to Bushido) and eight with traditional methods. Seven were lost due to follow-up. Both groups had comparable baseline characteristics and significantly improved after training, in all parameters assessed in this study. Subjects that trained with classical music were superior in terms of speed ( p  = 0.006), knot quality ( p  = 0.014), and procedural performance ( p  = 0.034) compared with controls.
CONCLUSION


Music during acquisition of complex motor skills, like laparoscopic suturing and knot tying, is superior to traditional training. Especially music considered nondisturbing significantly improved speed, knot quality, and performance. Thus, incorporation of pleasant music into surgical skills training and the OR should be considered.",2020,"Subjects that trained with classical music were superior in terms of speed ( p  = 0.006), knot quality ( p  = 0.014), and procedural performance ( p  = 0.034) compared with controls.
","['Twenty-four students were included in the study; after simple randomization, 16 were trained while exposed to music (eight to Bach and eight to Bushido) and eight with traditional methods']","['Classical but Not Rap Music', 'Laparoscopic Suturing Skills', 'laparoscopic suturing and knot tying']","['procedural performance', 'speed, knot quality, and performance', 'surgical performance', 'Total time, knot stability (evaluated via tensiometer), suture accuracy, knot quality (Muresan scale), and laparoscopic performance (Munz checklist', 'knot quality']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0053656', 'cui_str': 'succinimidyl-6-biotinamide hexanoate'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0681258', 'cui_str': 'Hip Hop Music'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3880387', 'cui_str': 'Tensiometer'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0222045'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.0628365,"Subjects that trained with classical music were superior in terms of speed ( p  = 0.006), knot quality ( p  = 0.014), and procedural performance ( p  = 0.034) compared with controls.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Mietzsch', 'Affiliation': 'Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bergholz', 'Affiliation': 'Department of General, Visceral and Thoracic Surgery, Section of Pediatric Surgery, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Boettcher', 'Affiliation': 'Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Klippgen', 'Affiliation': 'Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wenskus', 'Affiliation': 'Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Reinshagen', 'Affiliation': 'Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boettcher', 'Affiliation': 'Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",European journal of pediatric surgery : official journal of Austrian Association of Pediatric Surgery ... [et al] = Zeitschrift fur Kinderchirurgie,['10.1055/s-0039-3401798']
629,31203739,Facing the truth: are there hemifacial differences in the communication of trustworthiness?,"As the right hemisphere is dominant for emotion processing, the left cheek expresses emotion more intensely than the right cheek. This prompts a leftward bias: people offer the left cheek to communicate emotion and viewers perceive left cheek poses as more emotive. Perceptions of trustworthiness are positively influenced by emotional expressivity, with smiling faces deemed more trustworthy than neutral faces. Thus as the left hemiface is more emotionally expressive than the right, the present study sought to determine whether people offer the left cheek to communicate trustworthiness, and the right to express untrustworthiness. One hundred and twenty-six participants (57 males, 69 females) completed a posing task asking them to read one of two scenarios (randomly assigned: trusted babysitter; untrustworthy car salesman), consider it for 30 seconds, and then pose for a photograph communicating their trustworthiness or untrustworthiness. Contrary to expectation, binary logistic regression results indicated no posing bias for communicating trustworthiness, however people were more likely to offer the left than right cheek when posing to communicate untrustworthiness. The novel finding of a left cheek bias for untrustworthiness is previously unreported, and highlights the need for future investigations of trustworthiness to examine both sides of the trustworthy coin.",2020,"Perceptions of trustworthiness are positively influenced by emotional expressivity, with smiling faces deemed more trustworthy than neutral faces.","['One hundred and twenty-six participants (57 males, 69 females) completed a posing task asking them to read one of two scenarios (randomly assigned']",['trusted babysitter; untrustworthy car salesman'],[],"[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0337606', 'cui_str': 'Babysitter'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0402549', 'cui_str': 'Salesman (occupation)'}]",[],126.0,0.0234212,"Perceptions of trustworthiness are positively influenced by emotional expressivity, with smiling faces deemed more trustworthy than neutral faces.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Heywood-Smith', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Annukka K', 'Initials': 'AK', 'LastName': 'Lindell', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, Australia.'}]",Laterality,['10.1080/1357650X.2019.1631840']
630,31855244,Smoking and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients: a substudy from the randomized TROPICAL-ACS trial.,"AIMS


Prior analyses disclosed variations in antiplatelet drug response and clinical outcomes between smokers and non-smokers, thus the safety and efficacy of any dual antiplatelet therapy (DAPT) de-escalation strategy may differ in relation to smoking status. Hence, we assessed the impact of smoking on clinical outcomes and adenosine diphosphate-induced platelet aggregation following guided de-escalation of DAPT in invasively managed acute coronary syndrome (ACS) patients.
METHODS AND RESULTS


The multicentre TROPICAL-ACS trial randomized 2610 biomarker-positive ACS patients 1:1 to standard treatment with prasugrel for 12 months (control group) or a platelet function testing guided de-escalation of DAPT. Current smokers (n = 1182) showed comparable event rates between study groups [6.6% vs. 6.6%; hazard ratio (HR) 1.0, 95% confidence interval (CI) 0.64-1.56, P > 0.99]. In non-smokers (n = 1428), a guided DAPT de-escalation was associated with a lower 1-year incidence of the primary endpoint [cardiovascular death, myocardial infarction, stroke, or bleeding ≥ Grade 2 according to Bleeding Academic Research Consortium (BARC) criteria] compared with control group patients (7.9% vs. 11.0%; HR 0.71, 95% CI 0.50-0.99, P = 0.048). This reduction was mainly driven by a lower rate of BARC ≥ Grade 2 bleedings (5.2% vs. 7.7%; HR 0.68, 95% CI 0.45-1.03, P = 0.066). There was no significant interaction of smoking status with treatment effects of guided DAPT de-escalation (Pint = 0.23). Adenosine diphosphate-induced platelet aggregation values were higher in current smokers [median 28 U, interquartile range (IQR: 20-40)] vs. non-smoker [median 24 U (16-25), P < 0.0001] in the control group and in current smokers [median 42 U, IQR (27-68)] vs. non-smoker [median 37 U, IQR (25-55), P < 0.001] in the monitoring group.
CONCLUSION


Guided DAPT de-escalation appears to be equally safe and effective in smokers and non-smokers. Regardless of smoking status and especially for those patients deemed unsuitable for 1 year of potent platelet inhibition this DAPT strategy might be used as an alternative antiplatelet treatment regimen.",2020,"ADP-induced platelet aggregation values were higher in current smokers (median 28U, IQR [20-40]) vs. non-smoker (median 24U [16-25], P < 0.0001) in the control group as well as in current smokers (median 42U, IQR [27-68] vs. non-smoker (median 37U, IQR [25-55], P < 0.001) in the monitoring group.
","['Acute', 'invasively managed ACS patients', 'Coronary Syndrome Patients', 'smokers and non-smokers']","['DAPT', 'platelet function testing guided de-escalation of DAPT', 'prasugrel']","['event rates', 'ADP-induced platelet aggregation values', '1-year incidence of the primary endpoint (cardiovascular death, myocardial infarction, stroke, or bleeding ≥ grade 2 according to BARC criteria', 'rate of BARC ≥ grade 2 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",2610.0,0.0253516,"ADP-induced platelet aggregation values were higher in current smokers (median 28U, IQR [20-40]) vs. non-smoker (median 24U [16-25], P < 0.0001) in the control group as well as in current smokers (median 42U, IQR [27-68] vs. non-smoker (median 37U, IQR [25-55], P < 0.001) in the monitoring group.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Department of Cardiology and Angiology II, University Heart Centre Freiburg, Südring 15, 79189 Bad Krozingen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Geisler', 'Affiliation': 'Department of Cardiology and Cardiovascular Disease, University Hospital Tübingen, Otfried-Müller-Straße 10, 72076 Tübingen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rieber', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, Heart Centre Bogenhausen, Englschalkinger Straße 77, 81925 München, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hadamitzky', 'Affiliation': 'Department of Radiology, German Heart Center of Munich, Lazarettstraße 36, 80636 München, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gross', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Orban', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Kupka', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Baylacher', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Müller', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3 \xa0Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud Private University, Medical School, Montleartstrasse 35-37, 1160 Vienna, Austria.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Koltowski', 'Affiliation': '1 \xa0Department of Cardiology, Medical University of Warsaw, Żwirki i Wigury 61, 02-091 Warszawa, Poland.'}, {'ForeName': 'Zenon', 'Initials': 'Z', 'LastName': 'Huczek', 'Affiliation': '1 \xa0Department of Cardiology, Medical University of Warsaw, Żwirki i Wigury 61, 02-091 Warszawa, Poland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Heyn', 'Affiliation': 'Department of Anesthesiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Jacobshagen', 'Affiliation': 'Department of Cardiology and Pneumology, Heart Centre/Georg-August-University Göttingen, 37073 Göttingen, Germany.'}, {'ForeName': 'Dániel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Department of Cardiology, Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University, Gyógy tér 2 8230 Balatonfüred, Budapest, Hungary.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Massberg', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hein', 'Affiliation': 'Department of Cardiology, Ludwig-Maximilians University, Marchioninistraße 15, 81377 Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz084']
631,31773430,Correction to: Web-Based Intervention and Email‑Counseling for Problem Gamblers: Results of a Randomized Controlled Trial.,"The article ""Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial"" was written by Benjamin Jonas, Fabian Leuschner, Anna Eiling, Christine Schoelen, Renate Soellner and Peter Tossmann.",2020,"The article ""Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial"" was written by Benjamin Jonas, Fabian Leuschner, Anna Eiling, Christine Schoelen, Renate Soellner and Peter Tossmann.",['Problem Gamblers'],"['Correction to: Web-Based Intervention and Email‑Counseling', 'Web-Based Intervention and Email-Counseling']",[],"[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],,0.11313,"The article ""Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial"" was written by Benjamin Jonas, Fabian Leuschner, Anna Eiling, Christine Schoelen, Renate Soellner and Peter Tossmann.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jonas', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany. jonas@delphi.de.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Leuschner', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eiling', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schoelen', 'Affiliation': 'Federal Centre for Health Education (BZgA), Cologne, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Soellner', 'Affiliation': 'University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tossmann', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}]",Journal of gambling studies,['10.1007/s10899-019-09914-4']
632,31560101,Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial.,"Web-based interventions have the potential to reduce the treatment gap for problem gambling. In the past years, several web-based help options were made available to the public. However, only few studies were conducted to test their effects. This study investigated the efficacy of two interventions for problem gamblers provided online by the German Federal Center for Health Education (BZgA). The first intervention is the guided program ""Check Out"" (CO), the second is email counselling (EC). A web-based randomized controlled trial with follow-up surveys after 3, 6 and 12 months was conducted. Participants were allocated to CO, to EC or to a waitlist (WL). Outcomes were the degree of problem gambling according to the Problem Gambling Severity Index, the number of days gambled in past 30 days, the highest stake during the past 30 days and the subjective well-being (WHO-5). 167 individuals were included in the trial. In comparison to the WL at the 3 months follow-up, participants of CO showed significant improvements with moderate to strong effect sizes in all outcomes. Strongest effects were found in the problem gambling severity (d = 0.91; p = 0.023), followed by the well-being (d = 0.70; p = 0.011), the gambling days (d = 0.59; p = 0.001) and the highest stake (d = 0.55; p = 0.012). Improvements were sustained until last follow-up. Compared to the WL, users of EC had beneficiary results in the problem gambling severity (d = 0.74; p = 0.022). No significant effect differences were found between CO and EC. However, according to process evaluation, users of CO reported a significantly stronger working alliance than users of EC (d = 0.70; p = 0.019) and used the intervention considerably longer (d = 0.84; p = 0.004). CO helps treatment-seeking individuals to sustainably reduce their gambling behavior and to increase their general well-being. Compared to EC, CO seems a better support option, since its effects include a wider range of outcomes. Possible reasons are the more engaging program structure and elements of CO, as well as the closer interaction between client and counselor.",2020,"Strongest effects were found in the problem gambling severity (d = 0.91; p = 0.023), followed by the well-being (d = 0.70; p = 0.011), the gambling days (d = 0.59; p = 0.001) and the highest stake (d = 0.55; p = 0.012).","['167 individuals were included in the trial', 'problem gamblers provided online by the German Federal Center for Health Education (BZgA', 'Problem Gamblers']","['CO', 'Web-Based Intervention and Email-Counseling', 'guided program ""Check Out"" (CO), the second is email counselling (EC', 'CO, to EC or to a waitlist (WL']","['problem gambling severity', 'stronger working alliance', 'degree of problem gambling according to the Problem Gambling Severity Index, the number of days gambled in past 30\xa0days, the highest stake during the past 30\xa0days and the subjective well-being (WHO-5', 'gambling behavior']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",167.0,0.0467556,"Strongest effects were found in the problem gambling severity (d = 0.91; p = 0.023), followed by the well-being (d = 0.70; p = 0.011), the gambling days (d = 0.59; p = 0.001) and the highest stake (d = 0.55; p = 0.012).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jonas', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany. jonas@delphi.de.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Leuschner', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eiling', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schoelen', 'Affiliation': 'Federal Centre for Health Education (BZgA), Cologne, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Soellner', 'Affiliation': 'University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tossmann', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}]",Journal of gambling studies,['10.1007/s10899-019-09883-8']
633,31783028,"The safety and efficacy of 2% vitamin C solution spray for relief of mucosal irritation caused by Lugol chromoendoscopy: a multicenter, randomized, double-blind, parallel trial.","BACKGROUND AND AIMS


Lugol chromoendoscopy facilitates endoscopic visualization of esophageal dysplasia and carcinoma. Vitamin C solution (VCS) can theoretically neutralize free iodine, which causes mucosal irritation. The aim was to assess the safety and efficacy of VCS for relieving adverse symptoms caused by Lugol iodine staining.
METHODS


Two hundred forty eligible patients were randomized to receive 20 mL of normal saline solution (NS), 5% sodium thiosulfate solution (STS), or 2% VCS after spraying 10 mL of 2% Lugol iodine solution on the mid-distal esophagus. The primary endpoints were statistically significant reductions in acute and late adverse symptom severity scores. The secondary endpoint was the discoloration effect on esophageal brown iodine-stained mucosa.
RESULTS


Spraying both VCS and STS similarly decreased the severity scores of acute (NS vs VCS = 2.58 vs 1.61, P = .040; VCS vs STS = 1.61 vs 1.89, P > .999) and late (NS vs VCS = 1.70 vs 0.91, P = .002; VCS vs STS = 0.91 vs 1.38; P = .212) adverse symptoms after Lugol chromoendoscopy compared with spraying NS. Compared with STS spray, VCS spray alleviated acute acid regurgitation or heartburn (33% vs 15%, P = .017) and late retrosternal discomfort or pain (21% vs 9%, P = .027). Moreover, compared with spraying NS, spraying VCS quickly discolored the iodine-stained mucosa, with a better decolorization score (2.26 vs 3.56, P = .000), and the effects of fading iodine dye were similar between VCS and STS (3.56 vs 3.59, P = .908).
CONCLUSIONS


VCS can reduce mucosal irritation symptoms induced by Lugol chromoendoscopy and can be routinely recommended. (Chinese Clinical Trial Registry number: ChiCTR1900022000.).",2020,"RESULTS


Spraying both VCS and STS similarly decreased the severity scores of the acute (NS vs VCS = 2.58 vs 1.61, P = 0.040; VCS vs STS = 1.61",['Two hundred forty eligible subjects'],"['STS spray, VCS spray', 'vitamin C solution spray', 'VCS', '20 mL of normal saline solution (NS), 5% sodium thiosulfate solution (STS), or 2% VCS after spraying 10 mL of 2% Lugol iodine solution', 'Vitamin C solution (VCS']","['discoloration effect on esophageal brown iodine-stained mucosa', 'acute acid regurgitation or heartburn', 'acute and late adverse symptom severity scores', 'decolorization score', 'mucosal irritation', 'late retrosternal discomfort or pain', 'effects of fading iodine dye', 'severity scores', 'mucosal irritation symptoms', 'safety and efficacy', 'adverse symptoms']","[{'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C2350033', 'cui_str': 'sodium thiosulfate (USAN)'}, {'cui': 'C0065234', 'cui_str': 'potassium triiodide'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0857400', 'cui_str': 'Retrosternal discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013343', 'cui_str': 'Dyes'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0587867', 'cui_str': 'Irritation symptom (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",240.0,0.481501,"RESULTS


Spraying both VCS and STS similarly decreased the severity scores of the acute (NS vs VCS = 2.58 vs 1.61, P = 0.040; VCS vs STS = 1.61","[{'ForeName': 'Duochen', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Jinhu County People's Hospital, Huaian, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhan', 'Affiliation': ""Department of Gastroenterology and Hepatology, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Keting', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology and Hepatology, Wuxi People's Hospital Affiliated with Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Yinghong', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'First Clinical Medical College of Nanjing Medical University, Nanjing, China; Endoscopic Center, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': ""Department of Gastroenterology and Hepatology, Jinhu County People's Hospital, Huaian, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology and Hepatology, Jinhu County People's Hospital, Huaian, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Veterans Affairs Boston Healthcare System and Harvard Medical School, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China; First Clinical Medical College of Nanjing Medical University, Nanjing, China.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.028']
634,31687769,Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers.,"INTRODUCTION


Smoking is a key determinant of mortality among people living with HIV (PLWH).
METHODS


To better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH.
RESULTS


Among 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01).
CONCLUSIONS


HIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences.
IMPLICATIONS


PLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking.
TRIAL REGISTRATION


(1) Using ""warm handoffs"" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.",2020,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","['Hospitalized Smokers (HelpingHAND2', 'people living with HIV (PLWH', '5550 hospitalized smokers', 'hospitalized smokers with tobacco treatment after discharge', 'hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART', 'HIV-Infected Smokers', 'participants without HIV following a hospital-initiated smoking cessation intervention', 'urban hospital patients', 'cigarette smokers']","['usual care or a smoking cessation intervention', 'Post-Discharge Strategies', 'PLWH', 'smoking-cessation interventions', 'Smoking Cessation Interventions']","['Abstinence rates', 'smoking cessation', 'self-reported past 30-day tobacco abstinence', 'cessation rates', 'quit rates']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035168'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",,0.0487106,"At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%).","[{'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Triant', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Grossman', 'Affiliation': 'Cambridge Health Alliance, Somerville, MA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Ramachandran', 'Affiliation': 'Division of Preventive Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas, Nashville, TN.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Division of General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Nashville, TN.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Harrington', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, School of Medicine, University of Alabama, Birmingham, AL.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz168']
635,31733813,"Task-sharing of psychological treatment for antenatal depression in Khayelitsha, South Africa: Effects on antenatal and postnatal outcomes in an individual randomised controlled trial.","The study's objective was to determine the effectiveness of a task-sharing psychological treatment for perinatal depression using non-specialist community health workers. A double-blind individual randomised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town. Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS) were randomised into the intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls). The primary outcome was response on the Hamilton Depression Rating Scale (HDRS) at three months postpartum (minimum 40% score reduction from baseline) among participants who did not experience pregnancy or infant loss (modified intention-to-treat population) (registered on Clinical Trials: NCT01977326). Of 2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n = 200; intervention: n = 184). There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm. A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa. The findings give cause for reflection on the strategy of task-sharing in low-resource settings.",2020,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","['two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town', 'antenatal depression in Khayelitsha, South Africa', 'perinatal depression using non-specialist community health workers', 'Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS', '2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n\u202f=\u202f200; intervention: n\u202f=\u202f184', 'women living in Khayelitsha, South Africa']","['Task-sharing of psychological treatment', 'intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls', 'task-sharing psychological treatment']","['HDRS', 'Hamilton Depression Rating Scale (HDRS']","[{'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0222045'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",2187.0,0.206439,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","[{'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa; King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: crick.lund@uct.ac.za.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Garman', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Davies', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Memory', 'Initials': 'M', 'LastName': 'Munodawafa', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Honikman', 'Affiliation': 'Perinatal Mental Health Project, Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Medical Research Council, Durban, South Africa; Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bass', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Kagee', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa; MRC Unit on Risk & Resilience in Mental Disorders, Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Hanani', 'Initials': 'H', 'LastName': 'Tabana', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa, And School of Nursing and Midwifery, Queens University, Belfast, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK; Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.""}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, USA; New York State Psychiatric Institute, New York, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103466']
636,31782535,Effectiveness of a brief motivational intervention to increase the breastfeeding duration in the first 6 months postpartum: Randomized controlled trial.,"AIMS


To evaluate the effectiveness of a brief motivational intervention to increase the breastfeeding duration in the first 6 months postpartum in mothers who began breastfeeding in the first hour after birth and to explore the role of general and breastfeeding self-efficacy in this relationship.
DESIGN


A multi-centre randomized controlled clinical trial.
METHODS


Data were collected from February 2018 - March 2019. Women were randomly assigned to an intervention group that received a brief motivational intervention (N = 44) or a control group that was offered standard education on breastfeeding (N = 44). Survival analysis techniques were carried out with a follow-up of 6 months. In addition, the roles of breastfeeding and general self-efficacy in the association between BMI and breastfeeding duration were explored through mediation/moderation analysis.
RESULTS


Among 88 randomized patients (mean age, 32.82 years), 81 (92.04%) completed the trial. The survival analyses of exclusive breastfeeding and breastfeeding (exclusive and non-exclusive) showed reductions in the risk of abandonment in the intervention group of 63% (aHR: 0.37 [0.22-0.60] p < .001) and 61% (aHR: 0.39 [0.20-0.78] p = .008), respectively. We found that self-efficacy acted as a moderator of the effect of brief motivational intervention on breastfeeding self-efficacy. A discrete indirect effect of brief motivational intervention through increased breastfeeding self-efficacy was found on breastfeeding duration, with an index of moderated mediation of 0.08 (95% CI: 0.02-0.19). Greater positive variations in the breastfeeding self-efficacy scores during follow-up predicted exclusive and non-exclusive breastfeeding duration.
CONCLUSION


A brief motivational intervention conducted in the immediate postpartum period increases breastfeeding and exclusive breastfeeding duration in the first 6 months. Although breastfeeding self-efficacy seems to moderate the effect of brief motivational intervention on the increase in breastfeeding duration, other factors may influence its effectiveness. Further studies could focus on exploring how brief motivational intervention works and whether it also works for pregnant mothers who have not yet decided whether to breastfeed.
IMPACT


Brief motivational intervention could be introduced as part of routine care of women who begin breastfeeding to improve the low rates of exclusive breastfeeding at 6 months postpartum.
TRIAL REGISTRATION


Unique Protocol ID: Moti003; https://ClinicalTrials.gov ID: NCT03357549.",2020,The survival analyses of exclusive breastfeeding and breastfeeding (exclusive and non-exclusive) showed reductions in the risk of abandonment in the intervention group of 63% (aHR: 0.37 [0.22 - 0.60,"['88 randomized patients (mean age, 32.82\xa0years), 81 (92.04%) completed the trial', 'Data were collected from February 2018 - March 2019', 'pregnant mothers who have not yet decided whether to breastfeed', 'mothers who began breastfeeding in the first hour after birth', 'first six months postpartum']","['brief motivational intervention (N\xa0=\xa044) or a control group that was offered standard education on breastfeeding', 'motivational intervention', 'brief motivational intervention']","['breastfeeding self-efficacy', 'survival analyses of exclusive breastfeeding and breastfeeding', 'breastfeeding duration', 'breastfeeding and exclusive breastfeeding duration', 'breastfeeding self-efficacy scores', 'risk of abandonment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",88.0,0.0491239,The survival analyses of exclusive breastfeeding and breastfeeding (exclusive and non-exclusive) showed reductions in the risk of abandonment in the intervention group of 63% (aHR: 0.37 [0.22 - 0.60,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Franco-Antonio', 'Affiliation': 'Hospital Comarcal Don Benito-Villanueva, Badajoz, Spain.'}, {'ForeName': 'Julián F', 'Initials': 'JF', 'LastName': 'Calderón-García', 'Affiliation': 'Nursing Department, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Santano-Mogena', 'Affiliation': 'Nursing Department, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Rico-Martín', 'Affiliation': 'Nursing Department, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cordovilla-Guardia', 'Affiliation': 'Nursing Department, Nursing and Occupational Therapy College, University of Extremadura, Cáceres, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14274']
637,31784704,Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.,"PURPOSE


To compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).
METHODS


Prospective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577 nm micropulse laser. The spot size was 160 µm, the duty cycle was 5% and exposure time was 0.2 s. The power was 50% threshold tested. Patients in the TCL group were treated with 577 nm continuous laser. The power was 100% threshold tested. The primary outcome was the mean change in best-corrected visual acuity (BCVA) at week 12, with a non-inferiority limit of five letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
RESULTS


Eighty-eight patients were enroled. Seventy-seven patients were male. Forty-four patients were in SML group and 44 in TCL group. At week 12, SML was equivalent to TCL with a gain of 6.23 ± 8.59 and 6.61 ± 6.35 letters, respectively, (SML-TCL difference: -0.38 letters; 95% confidence interval (CI):-3.58-2.81; P non-inferiority  = 0.0026). There was no statistically significant difference between the two groups (t = 0.240, P = 0.811). At week 12, the proportion of patients whose SRF had been totally absorbed was 63.63 and 81.82% respectively for SML and TCL groups. There was no statistically significant difference between the two groups (χ 2  = 3.67, P = 0.056).
CONCLUSIONS


Both SML and TCL can improve visual acuity in CSC. SML was non-inferior to TCL in the improvement of BCVA.",2020,"There was no statistically significant difference between the two groups (χ 2  = 3.67, P = 0.056).
","['Forty-four patients were in SML group and 44 in TCL group', 'Eighty-eight patients were enroled', 'central serous chorioretinopathy (CSC', 'Seventy-seven patients were male', 'central serous chorioretinopathy']","['subthreshold micropulse laser compared with threshold conventional laser', 'subthreshold micropulse laser (SML) with threshold conventional laser (TCL', 'TCL', '577\u2009nm continuous laser', '577\u2009nm micropulse laser', 'SML group or TCL', 'SML', 'SML and TCL']","['spot size', 'efficacy and safety', 'mean change in best-corrected visual acuity (BCVA', 'Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts', 'Efficacy and safety', 'visual acuity']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0730328', 'cui_str': 'Central Serous Retinopathy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0183370', 'cui_str': 'Snellen eye chart'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",88.0,0.177868,"There was no statistically significant difference between the two groups (χ 2  = 3.67, P = 0.056).
","[{'ForeName': 'Zuhua', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bothwin Clinical Study Consultant, Redmond, WA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Optegra Eye Hospital, London, UK.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China. drliuxiaolin@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0692-8']
638,31784702,Observation of topical tacrolimus on high-risk penetrating keratoplasty patients: a randomized clinical trial study.,"BACKGROUND/OBJECTIVES


To evaluate the clinical efficacy of topical tacrolimus 0.1% and cyclosporine 1% on high-risk penetrating keratoplasty (PKP) patients.
SUBJECTS/METHODS


A series of 49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study. The patients were randomly divided into two groups by receiving either topical tacrolimus 0.1% or cyclosporine 1% respectively. Twenty five patients were treated with topical tacrolimus 0.1% and 24 patients with topical cyclosporine 1%. The traditional baseline management on these two groups were Tobramycin and Dexamethasone eye drops in the first 3 weeks and then tapered off. Clinical procedures and postoperative follow-up were documented.
RESULTS


After 6-54 months follow-up, with the average of 24 months, 11 of 24 high-risk patients (11 eyes) had graft rejection, the rejection rate was 45.8% in topical cyclosporine 1% group. The rejections occurred from 35 days to 20 months after PKP. Three patients had irreversible rejection. On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed. The graft rejection episodes were documented between 23 days and 24 months. As compared with the topical cyclosporine 1%, topical tacrolimus 0.1%, a key immunosuppressant, significantly decreased corneal graft rejection rate (p = 0.02).
CONCLUSIONS


Topical tacrolimus 01% on high-risk PKP patients significantly prevented corneal graft rejection, and it had less adverse effects and was very safe to high-risk patients as to topical cyclosporine 1%. Further case controlled randomized clinical trial studies are needed to establish the best management option for these high-risk patients.",2020,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","['49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study', 'high-risk penetrating keratoplasty (PKP) patients', 'high-risk penetrating keratoplasty patients', 'Twenty five patients were treated with']","['topical cyclosporine', 'Topical tacrolimus', 'topical tacrolimus', 'Tobramycin and Dexamethasone', 'topical tacrolimus 0.1% or cyclosporine', 'cyclosporine']","['rejection rate', 'graft rejection, the rejection rate', 'graft rejection episodes', 'rejections', 'corneal graft rejection', 'rejection', 'irreversible rejection', 'corneal graft rejection rate', 'adverse effects']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022592', 'cui_str': 'Keratoplasty, Penetrating'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C0877542', 'cui_str': 'Graft rejection episode'}, {'cui': 'C0339303', 'cui_str': 'Corneal graft rejection (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",2017.0,0.0279068,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Zhai', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Zhang', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China. zxr1110@sina.com.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Xu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}]","Eye (London, England)",['10.1038/s41433-019-0717-3']
639,32410485,"Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial.","Background A proposed cause of dyspnea induced by ticagrelor is an increase in adenosine blood levels. Because caffeine is an adenosine antagonist, it can potentially improve drug tolerability with regard to dyspnea. Furthermore, association between caffeine and cardiovascular events is of clinical interest. Methods and Results This prespecified analysis used data from the PEGASUS TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) trial, which randomized 21 162 patients with prior myocardial infarction to ticagrelor 60 mg or 90 mg or matching placebo (twice daily). Baseline caffeine intake in cups per week was prospectively collected for 9694 patients. Outcomes of interest included dyspnea, major adverse cardiovascular events (ie, the composite of cardiovascular death, myocardial infarction, or stroke), and arrhythmias. Dyspnea analyses considered the pooled ticagrelor group, whereas cardiovascular outcome analyses included patients from the 3 randomized arms. After adjustment, caffeine intake, compared with no intake, was not associated with lower rates of dyspnea in patients taking ticagrelor (adjusted hazard ratio (HR), 0.91; 95% CI, 0.76-1.10;  P =0.34). There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84). Conclusions In patients taking ticagrelor for secondary prevention after myocardial infarction, caffeine intake at baseline was not associated with lower rates of dyspnea compared with no intake. Otherwise, caffeine appeared to be safe in this population, with no apparent increase in atherothrombotic events or clinically significant arrhythmias. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01225562.",2020,"There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84).","['9694 patients', 'Patients With Prior Heart Attack Using', '162 patients with prior myocardial infarction to']","['Ticagrelor', 'Placebo', 'Aspirin-Thrombolysis', 'caffeine', 'ticagrelor 60\xa0mg or 90\xa0mg or matching placebo', 'ticagrelor']","['dyspnea, major adverse cardiovascular events (ie, the composite of cardiovascular death, myocardial infarction, or stroke), and arrhythmias', 'Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes', 'atrial fibrillation', 'major adverse cardiovascular events', 'rates of dyspnea', 'atherothrombotic events', 'sudden cardiac death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C4051377', 'cui_str': 'Ticagrelor 60 MG'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}]",21162.0,0.16121,"There was no excess risk with caffeine for major adverse cardiovascular events (adjusted HR, 0.78; 95% CI, 0.63-0.98;  P =0.031), sudden cardiac death (adjusted HR, 0.98; 95% CI, 0.57-1.70;  P =0.95), or atrial fibrillation (adjusted odds ratio, 1.07; 95% CI, 0.56-2.04;  P =0.84).","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Ramkumar V', 'Initials': 'RV', 'LastName': 'Venkateswaran', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor) Hospital das Clinicas da Faculdade de Medicina Universidade de Sao Paulo Brazil.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'University of Sheffield United Kingdom.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, and Assistance Publique-Hôpitaux de Paris Paris France.'}, {'ForeName': 'Giuglia', 'Initials': 'G', 'LastName': 'Magnani', 'Affiliation': 'University Hospital of Parma Italy.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Goto', 'Affiliation': 'Department of Medicine (Cardiology) Tokai University Hospital Isehara Japan.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Dellborg', 'Affiliation': 'Sahlgrenska Academy University of Gothenburg Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kamensky', 'Affiliation': 'Department of Non-invasive Cardiovascular Diagnostics University Hospital Bratislava Bratislava Slovakia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Isaza', 'Affiliation': 'Fundacion Cardioinfantil Instituto de Cardiologia Bogotá Colombia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aylward', 'Affiliation': 'South Australian Health and Medical Research Institute Flinders University and Medical Centre Adelaide Australia.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Mölndal Sweden.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group Brigham and Women's Hospital Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.015785']
640,31769181,The effect of a nurse-led self-management program on outcomes of patients with chronic obstructive pulmonary disease.,"PURPOSE


To examine the effectiveness of a nurse-led self-management program on outcomes of patients with chronic obstructive pulmonary disease (COPD).
DESIGN


A randomized controlled, single-blind trial, carried out from October 2017 to December 2018, included 154 participants admitted with COPD to the Affiliated Hospital of Zunyi Medical University in Guizhou, (randomized into intervention (n = 77) and control groups (n = 77)).
MATERIALS AND METHODS


Participants in the intervention group underwent a nurse-led self-management program in addition to routine care, and participants of the control group received only routine care. The main outcome measures were COPD-related readmission and emergency department visits, the 6-minute walk distance (6MWD) test for measurement of exercise capacity, the St George Respiratory Questionnaire (SGRQ) for measurement of health-related quality of life, and the COPD Transitional Care Patient Satisfaction Questionnaire (CTCPSQ) for measurement of satisfaction. Data collection was conducted at baseline (T1) and after 3 (T2), 6 (T3) and 12 mo (T4). Findings Compared to the control group, participants in the intervention group showed significantly fewer COPD-related hospital admissions (P = 0.03) and emergency department visits (P = 0.001) and higher total CTCPSQ scores (P = 0.001) at 12 mo. Meanwhile, analysis of variance showed a significantly greater improvement in exercise capacity and health status over time in the nurse-led program group than in the control group, P < 0.001.
CONCLUSIONS


This study demonstrated that the nurse-led self-management program was effective in decreasing hospital readmissions and emergency department visits and improving exercise capacity, health-related quality of life and satisfaction for patients with COPD.",2020,"This study demonstrated that the nurse-led self-management program was effective in decreasing hospital readmissions and emergency department visits and improving exercise capacity, health-related quality of life, and satisfaction for patients with COPD.","['Participants in the intervention group underwent a', 'October 2017 to December 2018, included 154 participants admitted with COPD to the Affiliated Hospital of Zunyi Medical University in Guizhou, (randomized into intervention (n=77) and control groups (n=77', 'patients with COPD', 'patients with chronic obstructive pulmonary disease', 'patients with chronic obstructive pulmonary disease (COPD']","['nurse-led self-management program', 'nurse-led self-management program in addition to routine care, and participants of the control group received only routine care']","['COPD-related readmission and emergency department visits, the 6-minute walk distance (6MWD) test for measurement of exercise capacity, the St George Respiratory Questionnaire (SGRQ) for measurement of health-related quality of life, and the COPD Transitional Care Patient Satisfaction Questionnaire (CTCPSQ) for measurement of satisfaction', 'exercise capacity and health status', 'total CTCPSQ scores', 'hospital readmissions and emergency department visits and improving exercise capacity, health-related quality of life, and satisfaction', 'COPD-related hospital admissions', 'emergency department visits']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3160837', 'cui_str': 'Walking distance test'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",154.0,0.0655509,"This study demonstrated that the nurse-led self-management program was effective in decreasing hospital readmissions and emergency department visits and improving exercise capacity, health-related quality of life, and satisfaction for patients with COPD.","[{'ForeName': 'Lian Hong', 'Initials': 'LH', 'LastName': 'Wang', 'Affiliation': 'Nursing department of Affiliated Hospital of Zunyi Medical University, ZunYi, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Nursing department of ZunYi Medical University, ZunYi, China.'}, {'ForeName': 'Ling Yun', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'Nursing department of ZunYi Medical University, ZunYi, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Nursing department of Affiliated Hospital of Zunyi Medical University, ZunYi, China.'}, {'ForeName': 'Yong Mei', 'Initials': 'YM', 'LastName': 'Zhang', 'Affiliation': 'Nursing department of ZunYi Medical University, ZunYi, China.'}]",The clinical respiratory journal,['10.1111/crj.13112']
641,31396815,Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial.,"BACKGROUND


Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown.
OBJECTIVE


To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control.
DESIGN


Three-arm pragmatic randomized controlled trial.
PATIENTS


One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit.
INTERVENTIONS


Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text).
MAIN MEASURES


Change in systolic BP during the final 4-month visit compared with baseline.
KEY RESULTS


At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
CONCLUSIONS


Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control.
TRIAL REGISTRATION


clinicaltrials.gov (NCT02778542).",2019,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
","['One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12\xa0months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit']","['Electronic Pill Bottles or Bidirectional Text Messaging', 'electronic pill bottles or bidirectional text messaging', 'usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text']","['systolic blood pressure', 'systolic BP', 'blood pressure control', 'Hypertension Medication Adherence']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",149.0,0.151629,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93).
","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. shivan.mehta@uphs.upenn.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Day', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05241-x']
642,31187937,Photodynamic therapy for severe facial acne vulgaris with 5% 5-aminolevulinic acid vs 10% 5-aminolevulinic acid: A split-face randomized controlled study.,"BACKGROUND


Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) has been described as an effective treatment for severe acne. However, very little evidence exists on the optimal concentration of ALA used in PDT for severe acne.
OBJECTIVES


To compare the efficacy and safety of PDT with 5% ALA vs 10% ALA in severe acne.
METHODS


Twenty-three patients with severe facial acne were randomly assigned to receive PDT with 5% ALA or 10% ALA on the left or right side of the face. Four PDT sessions were conducted with a light dose of 96 J/cm 2  . The reduction rates of lesion counts between the two groups were compared at the week-4 and week-12 follow-up visits. Effective rate at the week-12 visit was the primary clinical outcome. Pain and other side effects were evaluated at each visit.
RESULTS


The decrease in inflammatory lesions in the 10% ALA group was greater than that in the 5% ALA group at both week-4 (79.2% vs 62.5%, P = 0.009) and week-12 follow-up visits (88.5% vs 78.3%, P = 0.018), while the decrease in noninflammatory lesion counts between the two groups was not statistically significant at each follow-up visit. The effective rate in the 10% ALA group was significantly higher than that in the 5% ALA group (95.7% vs 69.6%, P = 0.02). No significant difference was observed in pain scores between the two groups except in the first treatment session.
CONCLUSIONS


Photodynamic therapy using 10% ALA was more effective for severe acne than PDT using 5% ALA.",2020,"No significant difference was observed in pain scores between the two groups except in the first treatment session.
","['severe facial acne vulgaris with 5', 'Twenty-three patients with severe facial acne']","['Photodynamic therapy', 'PDT', 'PDT with 5% ALA or 10% ALA', 'Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA', '5-aminolevulinic acid']","['Pain and other side effects', 'reduction rates of lesion counts', 'Effective rate', 'pain scores', 'efficacy and safety', 'effective rate', 'noninflammatory lesion counts', 'inflammatory lesions']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001144', 'cui_str': 'Acne Vulgaris'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0702166', 'cui_str': 'Acne'}]","[{'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}]",23.0,0.0418573,"No significant difference was observed in pain scores between the two groups except in the first treatment session.
","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun, Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Venereology, Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Dermatology, Shenzhen Children's Hospital, Guangzhou, Guangdong Province, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun, Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jiamin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun, Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Huaiqiu', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun, Yat-sen University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology and Venereology, The Third Affiliated Hospital of Sun, Yat-sen University, Guangzhou, Guangdong Province, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13038']
643,31471729,Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial.,"IMPORTANCE


Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.
OBJECTIVE


To test the effectiveness of a prediabetes SDM intervention.
DESIGN


Cluster randomized controlled trial.
SETTING


Twenty primary care clinics within a large regional health system.
PARTICIPANTS


Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m 2  and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.
INTERVENTION


Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care.
MAIN OUTCOMES AND MEASURES


Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months.
RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (- 5.3 vs. - 0.2, p < .001).
LIMITATIONS


Absence of DPP supplier participation data for matched patients in usual care clinics.
CONCLUSIONS AND RELEVANCE


A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk.
TRIAL REGISTRATION


This study was registered at clinicaltrails.gov (NCT02384109)).",2019,"RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (","['patients with prediabetes', 'SDM participants (n\xa0=\u2009351) than controls receiving usual care ', 'Overweight/obese adults with prediabetes (BMI\u2009≥\u200924\xa0kg/m 2  and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics', 'matched patients in usual care clinics', 'Diabetes Prevention', 'Twenty primary care clinics within a large regional health system']","['Shared decision-making (SDM', 'metformin', 'Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care', 'prediabetes SDM intervention']","['uptake of DPP (≥\u20099 sessions), metformin, or both strategies at 4\xa0months', 'weight loss', 'weight change', 'Uptake of DPP and/or metformin', 'adjusted weight loss', 'uptake of DPP and/or metformin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}]","[{'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",20.0,0.044247,"RESULTS


Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Moin', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA. tmoin@mednet.ucla.edu.'}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Turk', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Chon', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Dominick L', 'Initials': 'DL', 'LastName': 'Frosch', 'Affiliation': 'Palo Alto Medical Foundation Research Institute, Palo Alto, CA, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Kia Skrine', 'Initials': 'KS', 'LastName': 'Jeffers', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Yelba', 'Initials': 'Y', 'LastName': 'Castellon-Lopez', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Norris', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Mangione', 'Affiliation': 'David Geffen School of Medicine, University of California, Glendon Ave Suite, Los Angeles, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05238-6']
644,31175696,Evaluation of different concentrations of hydrogen peroxide solution (3% and 6%) as a potential new therapeutic option of nongenital warts: A randomized controlled triple-blinded clinical trial.,"BACKGROUND


Warts are common viral skin infections caused by human papillomavirus. None of the available treatment modalities fulfills the criteria of an ideal treatment option.
OBJECTIVES


To evaluate the efficacy and safety of hydrogen peroxide (HP) 3% and 6% solution as a topical treatment of nongenital warts.
METHODS


This prospective randomized controlled study included 145 patients with nongenital warts. They were divided into three groups. Group 1 used topical hydrogen peroxide 6% solution under occlusion with a plastic tape for one hour daily for 6 weeks, group 2 used hydrogen peroxide 3% solution, and group 3 used normal saline 0.9% as a placebo. Patients were evaluated at the third and sixth weeks of treatment and 12 weeks after treatment completion.
RESULTS


Treatment responses were significantly better in groups 1 and 2 than in group 3 with a better overall responses in group 1 than in group 2 (P = 0.0001*). Apart from mild hypopigmentation which was detected in only two patients in groups 1 and 2, no other side effects could be detected. Three months after treatment completion, no recurrence was observed.
CONCLUSION


Hydrogen peroxide solution (3% and 6%) is an effective, safe, and cheap treatment modality for nongenital warts which can be used simply at home. Since the overall response was better with the 6% concentration, it should be the better therapeutic option.",2020,"RESULTS


Treatment responses were significantly better in groups 1 and 2 than in group 3 with a better overall responses in group 1 than in group 2 (P = 0.0001*).","['nongenital warts', '145 patients with nongenital warts']","['hydrogen peroxide solution', 'hydrogen peroxide (HP', 'hydrogen peroxide 3% solution, and group 3 used normal saline 0.9% as a placebo', 'Hydrogen peroxide solution', 'topical hydrogen peroxide 6% solution under occlusion with a plastic tape']",[],"[{'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}]",[],145.0,0.0588478,"RESULTS


Treatment responses were significantly better in groups 1 and 2 than in group 3 with a better overall responses in group 1 than in group 2 (P = 0.0001*).","[{'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Mahran', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Howida Omar', 'Initials': 'HO', 'LastName': 'Twisy', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Shimaa A', 'Initials': 'SA', 'LastName': 'Elghazally', 'Affiliation': 'Public Health and Community Medicine Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Aya Y', 'Initials': 'AY', 'LastName': 'Badran', 'Affiliation': 'Dermatology, Venereology and Andrology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13021']
645,32409986,A pilot study of a group-based perinatal depression intervention on reducing depressive symptoms and improving maternal-fetal attachment and maternal sensitivity.,"To conduct a pilot study of a group-based perinatal depression intervention, the Mothers and Babies Course, on depressive symptomatology, maternal-fetal attachment, and maternal sensitivity, 60 pregnant women with moderate to severe depressive symptomatology were randomized to a 6-week intervention or usual care group at their initial prenatal care visit. Measures of depressive symptomatology and maternal-fetal attachment were collected at baseline and 36 weeks gestation. At 12 weeks postpartum, participants completed a measure of depressive symptomatology, and an objective measure of maternal sensitivity was collected. Participants randomized to the intervention group completed an average of 5.2 sessions, and 70% of women completed all six sessions. Exploratory analyses showed that at 12 weeks postpartum, participants randomized to the intervention group had an 8.32-point decrease from baseline on the Edinburgh Postnatal Depression Scale (EPDS) as compared to a 4.59-point decrease among participants randomized to usual care. Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care. Maternal sensitivity scores, assessed via the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST-Feeding), were higher at 12 weeks postpartum for women in the intervention group as compared to women in usual care (59.2 and 51.8, respectively). Our pilot study findings provide preliminary support for the benefits of a perinatal depression intervention, delivered in a group setting, on reducing depressive symptomatology, and improving maternal-fetal attachment and maternal sensitivity. Further research, conducted with larger samples, is necessary to determine the effect of this intervention on indicators of maternal attachment.",2020,Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care.,"['Mothers and Babies Course, on depressive symptomatology, maternal-fetal attachment, and maternal sensitivity, 60 pregnant women with moderate to severe depressive symptomatology']","['6-week intervention or usual care group at their initial prenatal care visit', 'group-based perinatal depression intervention']","['depressive symptomatology and maternal-fetal attachment', 'Edinburgh Postnatal Depression Scale (EPDS', 'depressive symptomatology', 'Maternal sensitivity scores, assessed via the Nursing Child Assessment Satellite Training-Feeding Scale (NCAST-Feeding', 'maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS', 'depressive symptoms and improving maternal-fetal attachment and maternal sensitivity', 'depressive symptomatology, and improving maternal-fetal attachment and maternal sensitivity']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",60.0,0.0857981,Participants randomized to the intervention group had a mean change score of 12.60 in maternal-fetal attachment via the Maternal Fetal Attachment Scale (MFAS) as compared to 4.60 among participants in usual care.,"[{'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Alhusen', 'Affiliation': 'University of Virginia School of Nursing, 225 Jeanette Lancaster Avenue, Charlottesville, VA, 22903, USA. Jla7e@virginia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Georgia State University, Urban Life, 140 Decatur Street, Atlanta, GA, 30303, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Borg', 'Affiliation': 'University of Virginia School of Nursing, 225 Jeanette Lancaster Avenue, Charlottesville, VA, 22903, USA.'}]",Archives of women's mental health,['10.1007/s00737-020-01032-0']
646,31919768,"Learnability and reproducibility of ACR Thyroid Imaging, Reporting and Data System (TI-RADS) in postgraduate freshmen.","PURPOSE


The Thyroid Imaging, Reporting and Data System (TI-RADS) from the American College of Radiology (ACR) has been used since 2017 for the evaluation of thyroid nodules. The purpose of this study is to assess the learnability and reproducibility of TI-RADS in postgraduate freshmen.
METHODS


This was a retrospective study involving 400 nodules with a final diagnosis following ultrasound (US) examination. The nodules were randomized into eight groups (50/group). Three postgraduate freshmen and three experts evaluated the nodules according to ACR TI-RADS without knowledge of the final diagnosis. After evaluating each group, training was carried out based on the inconsistencies of the freshmen/experts. Training was stopped after 200 nodules because the κ value showed almost perfect concordance. Three months later, the 50 nodules of Group 4 (the last evaluated group) were re-evaluated to assess the reproducibility of ACR TI-RADS.
RESULTS


The diagnostic accuracy of the three postgraduate freshmen increased from 60%, 48%, and 46% in Group 1 to 80%, 78%, and 72% in Group 4 (P= 0.029, 0.002, and 0.008), respectively. After training, the diagnostic accuracy of the postgraduate freshmen was close to that of the experts (84%). For the US features, the postgraduate freshmen were consistent with the experts (all κ > 0.6). When re-evaluating Group 4 three months later, the five features had substantial to almost perfect agreement for the same researcher (all κ > 0.7).
CONCLUSION


Based on experts' consensus, ACR TI-RADS can be learned well, and its reproducibility is excellent.",2020,"The diagnostic accuracy of the three postgraduate freshmen increased from 60%, 48%, and 46% in Group 1 to 80%, 78%, and 72% in Group 4 (P= 0.029, 0.002, and 0.008), respectively.",['400 nodules with a final diagnosis following ultrasound (US) examination'],['TI-RADS'],"['diagnostic accuracy of the postgraduate freshmen', 'reproducibility of ACR TI-RADS', 'diagnostic accuracy', 'Learnability and reproducibility of ACR Thyroid Imaging, Reporting and Data System']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]","[{'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0373397', 'cui_str': 'Thyroid imaging (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",400.0,0.0188304,"The diagnostic accuracy of the three postgraduate freshmen increased from 60%, 48%, and 46% in Group 1 to 80%, 78%, and 72% in Group 4 (P= 0.029, 0.002, and 0.008), respectively.","[{'ForeName': 'Dengke', 'Initials': 'D', 'LastName': 'Teng', 'Affiliation': 'Department of Ultrasound, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Ultrasound, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Breast Surgery, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Ultrasound, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China. guofeng_tdk@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Ultrasound, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin, China. wanghui_tdk@163.com.'}]",Endocrine,['10.1007/s12020-019-02161-y']
647,30654675,Evaluation of the effectiveness of transcutaneous nerve stimulation during labor in breech presentation: a case series.,"Objective:  To analyze the effectiveness of pain relief with transcutaneous electrical nerve stimulation (TENS) dispositive during labor in breech vaginal delivery and also to describe its tolerance and satisfaction. Design:  A randomized, double-blind, and placebo-controlled trial was conducted. Setting:  Labor room of Complejo Hospitalario Universitario Insular-Materno Infantil (Spain). Participants:  Ten women who met the inclusion criteria of the clinical trial and also had a fetus breech presentation were randomly assigned to three groups. Interventions:  A portable TENS, Cefar Rehab 2pro ® , unit was used to apply the experimental intervention, with different doses in the three groups in women during labor. The device intensity (amplitude) was individually adjusted to each participant's maximum sensory level. The pain was evaluated with visual analog scale (VAS). COMFORTS scale was used to measure women's satisfaction. Results:  A significant association of VAS was detected depending on the type of TENS over time. Active TENS2 was the only group that obtained an improvement with clinically significant results. In connection with women satisfaction, active TENS2 group was also the group that presented higher values. Conclusions:  We can recommend the use of TENS dispositive to relieve pain during labor, also in those women with breech presentation.",2021,Active TENS2 was the only group that obtained an improvement with clinically significant results.,"['Ten women who met the inclusion criteria of the clinical trial and also had a fetus breech presentation', 'Labor room of Complejo Hospitalario Universitario Insular-Materno']","['transcutaneous nerve stimulation', 'TENS dispositive', 'placebo', 'transcutaneous electrical nerve stimulation (TENS) dispositive during labor']","['VAS', 'device intensity (amplitude', 'pain', 'visual analog scale (VAS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0006157', 'cui_str': 'Labor Presentation, Breech'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",10.0,0.138167,Active TENS2 was the only group that obtained an improvement with clinically significant results.,"[{'ForeName': 'Aníbal', 'Initials': 'A', 'LastName': 'Báez Suárez', 'Affiliation': 'Department of Medical and Surgical Sciences, Universidad de Las Palmas de Gran Canaria Facultad de Ciencias de la Salud, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Martín Castillo', 'Affiliation': 'Department of Medical and Surgical Sciences, Universidad de Las Palmas de Gran Canaria Facultad de Ciencias de la Salud, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'García Andújar', 'Affiliation': 'Department of Medical and Surgical Sciences, Universidad de Las Palmas de Gran Canaria Facultad de Ciencias de la Salud, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'José Ángel', 'Initials': 'JÁ', 'LastName': 'García Hernández', 'Affiliation': 'Department of Medical and Surgical Sciences, Universidad de Las Palmas de Gran Canaria Facultad de Ciencias de la Salud, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'M Pino', 'Initials': 'MP', 'LastName': 'Quintana Montesdeoca', 'Affiliation': 'Department of Medical and Surgical Sciences, Universidad de Las Palmas de Gran Canaria Facultad de Ciencias de la Salud, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Loro Ferrer', 'Affiliation': 'Department of Medical and Surgical Sciences, Universidad de Las Palmas de Gran Canaria Facultad de Ciencias de la Salud, Las Palmas de Gran Canaria, Spain.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1572110']
648,31143111,A Multi-Ingredient Nutritional Supplement in Combination With Resistance Exercise and High-Intensity Interval Training Improves Cognitive Function and Increases  N -3 Index in Healthy Older Men: A Randomized Controlled Trial.,"We aimed to evaluate the effect of multi-ingredient nutritional supplementation, with and without exercise training, on cognitive function in healthy older men. Forty-nine sedentary men [age: 73 ± 6 years (mean ± SD); body mass index: 28.5 ± 3.6 kg/m 2 ] were randomized to consume a supplement (SUPP  n  = 25; 1500 mg  n -3 polyunsaturated fatty acids, 30 g whey protein, 2.5 g creatine, 500 IU vitamin D, and 400 mg calcium) or control beverage (CON  n  = 24; 22 g maltodextrin) twice daily for 20 weeks consisting of Phase 1: SUPP/CON followed by Phase 2: 12-week resistance exercise training plus high-intensity interval training, while continuing to consume the study beverages (SUPP/CON + EX). At baseline, 6 weeks, and 19 weeks we assessed cognitive function [Montréal Cognitive Assessment (MOCA)], memory [word recall during the Rey Auditory Verbal Learning Test (RAVLT)], executive functions (working memory inhibition control), and nutrient bioavailability. We did not observe changes to any aspect of cognitive function after Phase 1; however, significant improvements in the following cognitive function outcomes were detected following Phase 2: MOCA scores increased (6 weeks: 23.5 ± 3.3 vs. 19 weeks: 24.4 ± 2.5,  p  = 0.013); number of words recalled during the RAVLT increased (6 weeks: 6.6 ± 3.6 vs. 19 weeks: 7.6 ± 3.8,  p  = 0.047); and reaction time improved (6 weeks: 567 ± 49 ms vs. 19 weeks: 551 ± 51 ms,  p  = 0.002). Although between-group differences in these outcomes were not significant, we observed within-group improvements in composite cognitive function scores over the course of the entire study only in the SUPP group (Δ = 0.58 ± 0.62,  p  = 0.004) but not in the CON group (Δ = 0.31 ± 0.61,  p  = 0.06). We observed a progressive increase in  n -3 index, and a concomitant decrease in the ratio of arachidonic acid (ARA) to eicosapentaenoic acid (EPA) within erythrocyte plasma membranes, in the SUPP group only. At week 19,  n -3 index ( r  = 0.49,  p  = 0.02) and the ARA:EPA ratio ( r  = -0.44,  p  = 0.03) were significantly correlated with composite cognitive function scores. Our results show that 12 weeks of RET + HIIT resulted in improved MOCA scores, word recall, and reaction time during an executive functions task; and suggest that a multi-ingredient supplement combined with this exercise training program may improve composite cognitive function scores in older men possibly via supplementation-mediated alterations to  n -3 PUFA bioavailability.  Clinical Trial Registration : http://www.ClinicalTrials.gov, identifier NCT02281331.",2019,"MOCA scores increased (6 weeks: 23.5 ± 3.3 vs. 19 weeks: 24.4 ± 2.5,  p  = 0.013); number of words recalled during the RAVLT increased (6 weeks: 6.6 ± 3.6 vs. 19 weeks: 7.6 ± 3.8,  p  = 0.047); and reaction time improved (6 weeks: 567 ± 49 ms vs. 19 weeks: 551 ± 51 ms,  p  = 0.002).","['healthy older men', 'older men', 'Healthy Older Men', 'Forty-nine sedentary men [age: 73 ± 6 years (mean ± SD); body mass index: 28.5 ± 3.6 kg/m 2 ']","['consume a supplement (SUPP  n  = 25; 1500 mg  n -3 polyunsaturated fatty acids, 30 g whey protein, 2.5 g creatine, 500 IU vitamin D, and 400 mg calcium) or control beverage (CON  n  = 24; 22 g maltodextrin', 'RET + HIIT', 'exercise training program', 'SUPP/CON followed by Phase 2: 12-week resistance exercise training plus high-intensity interval training, while continuing to consume the study beverages (SUPP/CON + EX', 'High-Intensity Interval Training', 'multi-ingredient nutritional supplementation, with and without exercise training']","['cognitive function', 'reaction time', 'cognitive function outcomes', 'ARA:EPA ratio', 'ratio of arachidonic acid (ARA) to eicosapentaenoic acid (EPA', 'MOCA scores', 'composite cognitive function scores', 'MOCA scores, word recall, and reaction time during an executive functions task', 'cognitive function [Montréal Cognitive Assessment (MOCA)], memory [word recall during the Rey Auditory Verbal Learning Test (RAVLT)], executive functions (working memory inhibition control), and nutrient bioavailability', 'Cognitive Function and Increases  N -3 Index', 'number of words recalled during the RAVLT']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0450404', 'cui_str': '22G (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",-3.0,0.146925,"MOCA scores increased (6 weeks: 23.5 ± 3.3 vs. 19 weeks: 24.4 ± 2.5,  p  = 0.013); number of words recalled during the RAVLT increased (6 weeks: 6.6 ± 3.6 vs. 19 weeks: 7.6 ± 3.8,  p  = 0.047); and reaction time improved (6 weeks: 567 ± 49 ms vs. 19 weeks: 551 ± 51 ms,  p  = 0.002).","[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Bell', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Snijders', 'Affiliation': 'NUTRIM, Department of Human Biology, Maastricht University Medical Centre, Maastricht, Netherlands.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Allison', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Zulyniak', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chabowski', 'Affiliation': 'Department of Physiology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Parise', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Heisz', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2019.00107']
649,30206728,Prolonging the duration of post-infusion scalp cooling in the prevention of anthracycline-induced alopecia: a randomised trial in patients with breast cancer treated with adjuvant chemotherapy.,"PURPOSE


Scalp cooling as a method to reduce the incidence of chemotherapy-induced alopecia (CIA) is increasingly used in daily practice worldwide. However, in patients treated with 5-fluorouracil, epirubicin and cyclophosphamide (FEC), scalp cooling fails in 48-67% of patients. This study investigated the efficacy of extended duration of post-infusion scalp cooling in breast cancer patients treated with this regimen.
METHODS


In this prospective multi-centre randomised study, 102 patients with early breast cancer treated with adjuvant FEC chemotherapy were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 90 or 150 min. The primary endpoint was the need to wear a wig or other head covering to mask visible hair loss.
RESULTS


Sixteen out of 48 patients (33%) treated with 90 min of post-infusion cooling did not need any head covering, compared with 21 out of 46 patients (45%) treated with 150 min of post-infusion cooling (p = 0.2). WHO grades 2-3 (moderate-complete) alopecia were reported more often in patients treated with 90-min post-infusion cooling time (n = 25/51 (49%) versus n = 17/51 (33%); p = 0,02). Scalp cooling was well-tolerated (mean Visual Analogue Score 7.4) and only three patients (3%) stopped due to intolerance during treatment.
CONCLUSIONS


Extending the duration of 90-min post-infusion scalp cooling to 150 min in patients treated with adjuvant FEC chemotherapy was well-tolerated but did not significantly diminish the need for head covering. However, grades 2-3 alopecia was seen less often with prolonged post-infusion scalp cooling.",2019,"Scalp cooling was well-tolerated (mean Visual Analogue Score 7.4) and only three patients (3%) stopped due to intolerance during treatment.
","['patients with breast cancer treated with', 'breast cancer patients treated with this regimen', '102 patients with early breast cancer treated with', 'induced alopecia']","['anthracycline', '5-fluorouracil, epirubicin and cyclophosphamide (FEC), scalp cooling', 'adjuvant chemotherapy', 'adjuvant FEC chemotherapy']","['need to wear a wig or other head covering to mask visible hair loss', 'WHO grades 2-3 (moderate-complete) alopecia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0336553', 'cui_str': 'Wig, device (physical object)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",102.0,0.046127,"Scalp cooling was well-tolerated (mean Visual Analogue Score 7.4) and only three patients (3%) stopped due to intolerance during treatment.
","[{'ForeName': 'Manon M C', 'Initials': 'MMC', 'LastName': 'Komen', 'Affiliation': 'Department of Internal Medicine and Medical Oncology, Medical Centre Alkmaar, PO Box 501, AM, 1800, Alkmaar, The Netherlands. m.m.c.komen@nwz.nl.'}, {'ForeName': 'Corina J G', 'Initials': 'CJG', 'LastName': 'van den Hurk', 'Affiliation': 'Comprehensive Cancer Organisation the Netherlands, PO Box 19079, DB, 3501, Utrecht, The Netherlands.'}, {'ForeName': 'Johan W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Centre, PO Box 9600, RC, 2300, Leiden, The Netherlands.'}, {'ForeName': 'Tjeerd', 'Initials': 'T', 'LastName': 'van der Ploeg', 'Affiliation': 'Business, Finance and Law department, Inholland Alkmaar, PO Box 501, AM, 1800, Alkmaar, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nieboer', 'Affiliation': 'Department of Medical Oncology, Wilhelmina Ziekenhuis Assen, Europaweg-Zuid 1, RK, 9401, Assen, The Netherlands.'}, {'ForeName': 'Jacobus J M', 'Initials': 'JJM', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Centre, Geert Grooteplein Zuid 10, GA, 6525, Nijmegen, The Netherlands.'}, {'ForeName': 'Carolien H', 'Initials': 'CH', 'LastName': 'Smorenburg', 'Affiliation': 'Department of Medical Oncology, Antoni van Leeuwenhoek, Plesmanlaan 121, CX, 1066, Amsterdam, The Netherlands.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4432-6']
650,31172849,Characterizing lymphocyte counts and infection rates with long-term teriflunomide treatment: Pooled analysis of clinical trials.,"BACKGROUND


In Phase 3 studies, teriflunomide reduced relapse rates and disability progression compared with placebo; however, decreases in lymphocyte counts were also observed.
OBJECTIVE


To describe the effect of long-term teriflunomide treatment on lymphocyte counts and infection rates among patients in pooled analyses of Phase 3 core and extension studies.
METHODS


Four randomized trials (TEMSO, TOWER, TENERE, and TOPIC) compared teriflunomide 7 mg or 14 mg treatment with either placebo and/or subcutaneous interferon (IFN) β-1a 44 µg in patients with relapsing forms of multiple sclerosis (MS) (or first clinical episode suggestive of MS in TOPIC).
RESULTS


In 1895, patients ever exposed to teriflunomide, mean (standard deviation) absolute lymphocyte counts declined from Week 0 (1.89 (0.59)) to Week 24 (1.67 (0.52)) and then remained stable thereafter. In the core plus extension studies (up to 10.7 years), 7.3% and 2.2% experienced Grade 1 and Grade 2 lymphopenia, respectively. Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia. Serious infections occurred in 3.7%, 4.3%, and 7.1%, respectively.
CONCLUSION


Long-term risk of lymphopenia and infections in patients who continue to receive teriflunomide is low, demonstrating a limited impact on adaptive and innate immunity.",2020,"Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia.","['patients in pooled analyses of Phase 3 core and extension studies', 'patients with relapsing forms of multiple sclerosis (MS) (or first clinical episode suggestive of MS in TOPIC']","['teriflunomide', 'placebo and/or subcutaneous interferon (IFN) β-1a 44\u2009µg', 'placebo', 'long-term teriflunomide']","['relapse rates and disability progression', 'Serious infections', 'lymphocyte counts', 'lymphocyte counts and infection rates', 'Characterizing lymphocyte counts and infection rates', 'Infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}]","[{'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]",1895.0,0.111965,"Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519851981']
651,31173464,"A study of efficacy and safety of high-intensity focused ultrasound for the treatment of melasma in Asians: A single-blinded, randomized, split-face, pilot study.","BACKGROUND


A recent report suggested potential of high-intensity focused ultrasound in improving UVB-induced hyperpigmentation in patients with Fitzpatrick skin type IV, but reports regarding its efficacy in other hyperpigmented conditions including melasma are lacking.
OBJECTIVES


To investigate efficacy and safety of high-intensity focused ultrasound for the treatment of melasma in Asians.
METHODS


Each side of the face of 25 melasma patients was randomized to receive 3-monthly sessions of high-intensity focused ultrasound treatment or serve as control. Lightness index, Melasma Area and Severity Index of malar area (MASI m  ) by blinded dermatologists, self-evaluated improvement and satisfaction scales by patients, and side effects were assessed every 4 weeks for 20 weeks.
RESULTS


Twenty-one patients with Fitzpatrick skin type III and IV completed the study. There was a greater reduction of relative lightness index and MASI m  after treatment in high-intensity focused ultrasound-treated side. However, there were no statistically significant differences between both sides. More than 50% improvement on treatment side was rated in 11 patients (52.4%). Side effects were minimal. None had worsening of melasma.
CONCLUSIONS


High-intensity focused ultrasound may be an adjuvant for treatment of melasma. Further studies with larger sample size and proper parameter settings are recommended to determine its efficacy.",2020,There was a greater reduction of relative lightness index and MASI m  after treatment in high-intensity focused ultrasound-treated side.,"['melasma in Asians', 'patients with Fitzpatrick skin type IV', 'Twenty-one patients with Fitzpatrick skin type III and IV completed the study', '25 melasma patients']","['high-intensity focused ultrasound treatment or serve as control', 'high-intensity focused ultrasound']","['worsening of melasma', 'relative lightness index and MASI m', 'Lightness index, Melasma Area and Severity Index of malar area (MASI m  ) by blinded dermatologists, self-evaluated improvement and satisfaction scales']","[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441732', 'cui_str': 'Type 4 (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}]",21.0,0.111755,There was a greater reduction of relative lightness index and MASI m  after treatment in high-intensity focused ultrasound-treated side.,"[{'ForeName': 'Vasanop', 'Initials': 'V', 'LastName': 'Vachiramon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wimolsiri', 'Initials': 'W', 'LastName': 'Iamsumang', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nongsak', 'Initials': 'N', 'LastName': 'Chanasumon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Korn', 'Initials': 'K', 'LastName': 'Triyangkulsri', 'Affiliation': 'Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13044']
652,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION


Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS


One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS


The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS


Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2  peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
653,31157522,Effect of four sessions of aerobic exercise with abdominal radiofrequency in adipose tissue in healthy women: Randomized control trial.,"BACKGROUND


Abdominal adiposity is a cardiovascular risk factor; it is assumed that the combination of radiofrequency and physical exercise may decrease this excess of adipose tissue.
PURPOSE


To analyze the effect of four intervention sessions on abdominal adipose tissue.
METHODOLOGY


The study analyzes the effect of four sessions of aerobic exercise combined with radiofrequency. Participants were 28 healthy female volunteers, aged 18-28 years, randomly assigned to an experimental group and a placebo group. They were characterized by a sociodemographic questionnaire, the International Physical Activity Questionnaire and the Food Frequency Questionnaire. The groups performed four sessions of abdominal radiofrequency followed by moderate aerobic exercise, assessing body mass, body mass index, fat mass, waist circumference, waist/height ratio, subcutaneous adipose thickness, and horizontal abdominal adipose fold at the first and fourth sessions. In the experimental group, a percentage of potency was used that allowed to maintain the temperature between 40°C and 42°C to the epidermis. In the placebo group, the power of the radiofrequency was 0 W. To compare results, Student's t test was used for a significance level of 0.05.
RESULTS


There was a statistically significant decrease in waist circumference, abdominal subcutaneous adipose thickness, and horizontal abdominal fold in the experimental group compared to the placebo group (P < 0.05).
CONCLUSION


Combined exercise intervention with radiofrequency has been shown to be effective in reducing abdominal adiposity.",2020,"There was a statistically significant decrease in waist circumference, abdominal subcutaneous adipose thickness, and horizontal abdominal fold in the experimental group compared to the placebo group (P < 0.05).
","['healthy women', 'Participants were 28 healthy female volunteers, aged 18-28\xa0years']","['placebo', 'Combined exercise intervention with radiofrequency', 'aerobic exercise with abdominal radiofrequency', 'abdominal radiofrequency followed by moderate aerobic exercise', 'aerobic exercise combined with radiofrequency']","['waist circumference, abdominal subcutaneous adipose thickness, and horizontal abdominal fold', 'sociodemographic questionnaire, the International Physical Activity Questionnaire and the Food Frequency Questionnaire']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",28.0,0.129286,"There was a statistically significant decrease in waist circumference, abdominal subcutaneous adipose thickness, and horizontal abdominal fold in the experimental group compared to the placebo group (P < 0.05).
","[{'ForeName': 'Ana Luísa', 'Initials': 'AL', 'LastName': 'Vale', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Portugal.'}, {'ForeName': 'Ana Sofia', 'Initials': 'AS', 'LastName': 'Pereira', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Portugal.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Morais', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Vilarinho', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Portugal.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Mendonça', 'Affiliation': 'Department of Applied Physiotherapy, Health Sciences Institute, Federal University of Triângulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Noites', 'Affiliation': 'Department of Physiotherapy, School of Health, Polytechnic Institute of Porto, Portugal.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13036']
654,31167195,Benchmarking against the MOMS Trial: Zurich Results of Open Fetal Surgery for Spina Bifida.,"INTRODUCTION


The Management of Myelomeningocele Study, a.k.a. the MOMS trial, was published in 2011 in the New England Journal of Medicine. This prospective randomized controlled trial proved to be a milestone publication that provided definitive evidence that fetal surgery is a novel standard of care for select fetuses with spina bifida aperta (SB). The goal of our study is to assess whether our center can match these benchmark results.
MATERIALS AND METHODS


Our study was conducted according to the MOMS protocol using the same inclusion and exclusion criteria and looked at the same outcome parameters that were used in the MOMS trial. Zurich and MOMS results were compared.
RESULTS


We enrolled 20 patients between December 2010 and May 2015 all of whom underwent fetal surgery for SB. Among 51 different outcome variables, there were only 3 favorable (multiplicity-adjusted) significant differences (gestational age at birth, hindbrain herniation, and psychomotor development). There were no statistically significant differences regarding any other parameters.
CONCLUSION


Our findings confirm that rigorous apprenticeship, training, and comprehensive prospective data collection enable centers like the Zurich Center for Fetal Diagnosis and Therapy to achieve benchmark results for open fetal surgery for myelomeningocele and myeloschisis. These results justify the existence and continuation of our program. Outcome documentation is an essential element of quality management. It is medically and ethically fundamental for fetal medicine and surgery centers offering high-end innovative medical care.",2020,"There were no statistically significant differences regarding any other parameters.
","['We enrolled 20 patients between December 2010 and May 2015 all of whom underwent fetal surgery for SB', 'fetuses with spina bifida aperta (SB', 'Spina Bifida']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C1261465', 'cui_str': 'Operation on fetus (procedure)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0037917', 'cui_str': 'Spina Bifida Manifesta'}, {'cui': 'C0080178', 'cui_str': 'Schistorrhachis'}]",[],[],20.0,0.0527701,"There were no statistically significant differences regarding any other parameters.
","[{'ForeName': 'Ueli', 'Initials': 'U', 'LastName': 'Möhrlen', 'Affiliation': ""Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ochsenbein-Kölble', 'Affiliation': 'The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mazzone', 'Affiliation': ""Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Kraehenmann', 'Affiliation': 'The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hüsler', 'Affiliation': 'The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Casanova', 'Affiliation': ""Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Biro', 'Affiliation': ""Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wille', 'Affiliation': ""Department of Pediatric Neurology, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Latal', 'Affiliation': ""Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Ianina', 'Initials': 'I', 'LastName': 'Scheer', 'Affiliation': 'The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bernet', 'Affiliation': ""Department of Intensive Care and Neonatology, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Theres', 'Initials': 'T', 'LastName': 'Moehrlen', 'Affiliation': ""Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Held', 'Affiliation': 'Department of Biostatistics, Institute for Epidemiology, Biostatistics and Prevention, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Flake', 'Affiliation': ""The Center for Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zimmermann', 'Affiliation': 'The Zurich Center for Fetal Diagnosis and Therapy, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meuli', 'Affiliation': ""Department of Pediatric Surgery, University Children's Hospital Zurich, Zurich, Switzerland, martin.meuli@kispi.uzh.ch.""}]",Fetal diagnosis and therapy,['10.1159/000500049']
655,31755587,Effect of enantiomerism on the bioequivalence of a new ibuprofen 600-mg tablet formulation obtained by roller compaction.,"The bioequivalence of a new ibuprofen 600-mg film-coated tablet obtained by roller compaction was studied in a crossover study with 22 healthy volunteers. Bioequivalence was analyzed based on (a) the S-enantiomer, (b) the R-enantiomer, and (c) the sum of both enantiomers (representing the results of an achiral assay). The bioequivalence conclusion for ibuprofen products should be based not only on AUC and Cmax but also on tmax since tmax is related to the onset of action. However, it is not possible to ensure if bioequivalence has been demonstrated for tmax as regulators have not defined the acceptance range for the difference between medians of tmax in those cases, where tmax is clinically relevant. In this study, it was possible to conclude bioequivalence for tmax based on S-ibuprofen, though this conclusion might be questioned if the decision is based on R-ibuprofen or the achiral method.",2020,"In this study, it was possible to conclude bioequivalence for tmax based on S-ibuprofen, though this conclusion might be questioned if the decision is based on R-ibuprofen or the achiral method.",['22 healthy volunteers'],['ibuprofen'],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]",[],,0.0149975,"In this study, it was possible to conclude bioequivalence for tmax based on S-ibuprofen, though this conclusion might be questioned if the decision is based on R-ibuprofen or the achiral method.","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Matji', 'Affiliation': 'Pharmaceutics and Food Technology, Complutense University Madrid, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Vargas', 'Affiliation': 'Clinical Pharmacology Service, Pharmacology, Hospital Clínico San Carlos, Complutense University of Madrid/IdISSC, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Carvajal', 'Affiliation': 'Pharmaceutics and Food Technology, Complutense University Madrid, Madrid, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Terleira', 'Affiliation': 'Clinical Pharmacology Service, Pharmacology, Hospital Clínico San Carlos, Complutense University of Madrid/IdISSC, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Portolés', 'Affiliation': 'Clinical Pharmacology Service, Pharmacology, Hospital Clínico San Carlos, Complutense University of Madrid/IdISSC, Madrid, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Garcia-Arieta', 'Affiliation': 'Pharmacology and Clinical Evaluation, Human Use Medicines, Spanish Agency for Medicines and Health Care Products, Madrid, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Torrado', 'Affiliation': 'Pharmaceutics and Food Technology, Complutense University Madrid, Madrid, Spain.'}, {'ForeName': 'Dolores R', 'Initials': 'DR', 'LastName': 'Serrano', 'Affiliation': 'Pharmaceutics and Food Technology, Complutense University Madrid, Madrid, Spain.'}]",Chirality,['10.1002/chir.23148']
656,31747355,Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial.,"Background:  The efficacy of Vitamin C (L-ascorbic acid) supplementation can be assessed by uptake into the blood and retention in leukocytes. Vitafusion® Power C gummy is an alternative vitamin C source which may exhibit similar bioavailability to comparator caplets. Objective:  The objective of this study was to evaluate the bioequivalence of vitamin C from a vitafusion® Power C gummy formulation and a comparator caplet in healthy adults. Methods:  Thirty healthy men and women, 34.0 ± 11.4 years of age and Body Mass Index (BMI) 24.5 ± 3.6 kg/m 2  completed the randomized examiner-blind, comparator controlled, cross-over trial with two sequences: gummy (1000 mg) to caplet (1000 mg) or caplet to gummy. Intake of foods fortified with Vitamin C was restricted 7 days prior to each dosing. Blood samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 h post-dose for plasma and leukocytes; and urine was collected pre-dose and between 0-2, 2-4, 4-8, 8-12 and 12-24 h post-dose for L-ascorbic acid analysis. Results:  Vitafusion® Power C gummy and comparator caplet demonstrated similar plasma absorption profiles as there were no significant differences in plasma L-ascorbic acid total Area Under the Curve (AUC) 0-24h , and T max  between gummy and caplet. The caplet did elicit a significantly higher C max  than the gummy ( p  < 0.05), however, the difference was numerically small. Leukocyte L-ascorbic acid total AUC 0-24h  and C max  were not significantly different between gummy and caplet, however T max  of the gummy group was significantly longer ( p  = 0.012). Urinary L-ascorbic acid levels were also not significantly different between gummy and caplet. There were no serious adverse events and safety parameters remained within normal clinical range for both products. Conclusion:  Vitafusion® Power C gummy exhibited similar Vitamin C absorption and bioavailability to a comparator caplet in healthy adults and were considered bioequivalent.",2020,"Leukocyte L-ascorbic acid total AUC 0-24h  and C max  were not significantly different between gummy and caplet, however T max  of the gummy group was significantly longer ( p  = 0.012).","['Healthy Adults', 'Thirty healthy men and women, 34.0\u2009±\u200911.4 years of age and Body Mass Index (BMI) 24.5\u2009±\u20093.6\u2009kg/m 2', 'healthy adults']","['Vitamin C Bioequivalence', 'foods fortified with Vitamin C', 'Vitafusion®', 'vitamin C', 'caplet (1000\u2009mg) or caplet to gummy', 'Vitamin C (L-ascorbic acid) supplementation']","['Leukocyte L-ascorbic acid total AUC 0-24h  and C max', 'serious adverse events and safety parameters', 'Urinary L-ascorbic acid levels', 'Vitamin C absorption and bioavailability', 'plasma L-ascorbic acid total Area Under the Curve (AUC) 0-24h , and T max']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039789', 'cui_str': 'Generic Equivalency'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",30.0,0.100215,"Leukocyte L-ascorbic acid total AUC 0-24h  and C max  were not significantly different between gummy and caplet, however T max  of the gummy group was significantly longer ( p  = 0.012).","[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc, London, Ontario, Canada.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc, London, Ontario, Canada.'}, {'ForeName': 'H Kelly', 'Initials': 'HK', 'LastName': 'Zhang', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hooper', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}, {'ForeName': 'Annahita', 'Initials': 'A', 'LastName': 'Ghassemi', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1684398']
657,31128268,A Double-Blind Randomized Placebo-Controlled Trial of Citalopram Adjunctive to Stimulant Medication in Youth With Chronic Severe Irritability.,"OBJECTIVE


Despite the clinical importance of chronic and severe irritability, there is a paucity of controlled trials for its pharmacological treatment. Here, we examine the effects of adding citalopram (CTP) to methylphenidate (MPH) in the treatment of chronic severe irritability in youth using a double-blind randomized placebo-controlled design.
METHOD


After a lead-in phase of open treatment with stimulant, 53 youth meeting criteria for severe mood dysregulation (SMD) were randomly assigned to receive CTP or placebo (PBO) for 8 weeks. A total of 49 participants, 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria, were included in the intent-to-treat analysis. The primary outcome measure was the proportion of response based on improvements of irritability at the week 8 of the trial.
RESULTS


At the end of the trial, a significantly higher proportion of response was seen in those participants randomly assigned to CTP+MPH compared to PBO+MPH (35% CTP+MPH versus 6% PBO+MPH; odds ratio = 11.70, 95% CI = 2.00-68.16, p = 0.006). However, there were no differences in functional impairment between groups at the end of the trial. No differences were found in any adverse effect between treatment groups, and no trial participant exhibited hypomanic or manic symptoms.
CONCLUSION


Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone.
CLINICAL TRIAL REGISTRATION INFORMATION


A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation; https://clinicaltrials.gov; NCT00794040.",2020,Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone.,"['Youth With Chronic Severe Irritability', 'chronic severe irritability in youth', '53 youth meeting criteria for severe mood dysregulation (SMD', 'Forty-nine participants - 48 of them (98%) meeting disruptive mood dysregulation disorder (DMDD) criteria - were included in the intent-to-treat analysis']","['Adjunctive CTP', 'methylphenidate (MPH', 'Citalopram Adjunctive to Stimulant Medication', 'placebo', 'Placebo', 'PBO+MPH', 'CTP+MPH', 'CTP or placebo (PBO', 'citalopram (CTP']","['functional impairment', 'proportion of response', 'hypomanic or manic symptoms', 'adverse effect', 'proportion of response based on improvements of irritability']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C4065471', 'cui_str': 'Disruptive mood dysregulation disorder (disorder)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0010734', 'cui_str': 'CRPPP'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}]",,0.474108,Adjunctive CTP might be efficacious in the treatment of chronic severe irritability in youth resistant to stimulant treatment alone.,"[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Towbin', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Vidal-Ribas', 'Affiliation': ""Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD; Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Brotman', 'Affiliation': 'Neuroscience and Novel Therapeutics, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK.""}, {'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Miller', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Kaiser', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Aria D', 'Initials': 'AD', 'LastName': 'Vitale', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Chana', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Gerald P', 'Initials': 'GP', 'LastName': 'Overman', 'Affiliation': 'National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, University of Arizona, Tuscon.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Wheeler', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Yokum', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Catherine T', 'Initials': 'CT', 'LastName': 'Haring', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roule', 'Affiliation': 'Penn State University, State College, PA.'}, {'ForeName': 'Caroline G', 'Initials': 'CG', 'LastName': 'Wambach', 'Affiliation': 'Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Banafsheh', 'Initials': 'B', 'LastName': 'Sharif-Askary', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Development and Affective Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Leibenluft', 'Affiliation': 'Section on Mood Dysregulation and Neuroscience, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Argyris', 'Initials': 'A', 'LastName': 'Stringaris', 'Affiliation': 'Mood Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health, Bethesda, MD. Electronic address: argyris.stringaris@nih.gov.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.05.015']
658,31750855,Effect of Supplementation With Marine ω-3 Fatty Acid on Risk of Colorectal Adenomas and Serrated Polyps in the US General Population: A Prespecified Ancillary Study of a Randomized Clinical Trial.,"Importance


Marine ω-3 fatty acid has been suggested to protect against colorectal cancer.
Objective


To assess the effect of daily marine ω-3 fatty acid supplementation on the risk of colorectal cancer precursors, including conventional adenomas and serrated polyps.
Design, Setting, and Participants


This study was a prespecified ancillary study of the placebo-controlled randomized clinical trial VITAL (Vitamin D and Omega-3 Trial). An intention-to-treat analysis was used to examine the effect of daily marine ω-3 supplements among 25 871 adults in the US general population (including 5106 African American persons) free of cancer and cardiovascular disease at enrollment. Randomization was from November 2011 to March 2014, and intervention ended as planned on December 31, 2017.
Interventions


Marine ω-3 fatty acid, 1 g daily (which included eicosapentaenoic acid, 460 mg, and docosahexaenoic acid, 380 mg) and vitamin D3 (2000 IU daily) supplements.
Main Outcomes and Measures


Risk of conventional adenomas (including tubular adenoma, tubulovillous adenoma, villous adenoma, and adenoma with high-grade dysplasia) or serrated polyps (including hyperplastic polyp, traditional serrated adenoma, and sessile serrated polyp). In a subset of participants who reported receiving a diagnosis of polyp on follow-up questionnaires, endoscopic and pathologic records were obtained to confirm the diagnosis. Odds ratios (ORs) and 95% CIs were calculated using logistic regression, after adjusting for age, sex, vitamin D treatment assignment, and use of endoscopy. Secondary analyses were performed according to polyp features and participants' characteristics.
Results


The demographic characteristics of participants at randomization were well balanced between the treatment and placebo groups; for example, 50.6% vs 50.5% were women, and 19.7% vs 19.8% were African American persons were included in each group. The mean (SD) age was 67.1 (7.1) years in the placebo group and 67.2 (7.1) in the ω-3 treatment group. During a median follow-up of 5.3 years (range, 3.8-6.1 years), 294 cases of conventional adenomas were documented in the ω-3 group and 301 in the control group (multivariable OR, 0.98; 95% CI, 0.83-1.15) (1:1 ratio between number of cases and number of participants). In addition, 174 cases of serrated polyps were documented in the ω-3 group and 167 in the control group (OR, 1.05; 95% CI, 0.84-1.29). Null associations were found for polyp subgroups according to size, location, multiplicity, or histology. In secondary analyses, marine ω-3 treatment appeared to be associated with lower risk of conventional adenomas among individuals with low plasma levels of ω-3 index at baseline (OR, 0.76; 95% CI, 0.57-1.02; P = .03 for interaction by ω-3 index). A beneficial association of supplementation was also noted in the African American population (OR, 0.59; 95% CI, 0.35-1.00) but not in other racial/ethnic groups (P = .11 for interaction).
Conclusions and Relevance


Supplementation with marine ω-3 fatty acids, 1 g per day, was not associated with reduced risk of colorectal cancer precursors. A potential benefit of this supplementation for individuals with low baseline ω-3 levels or for African American persons requires further confirmation.
Trial Registration


ClinicalTrials.gov identifier: NCT01169259.",2019,"A beneficial association of supplementation was also noted in the African American population (OR, 0.59; 95% CI, 0.35-1.00) but not in other racial/ethnic groups (P = .11 for interaction).
","['groups; for example, 50.6% vs 50.5% were women, and 19.7% vs 19.8% were African American persons', '25\u202f871 adults in the US general population (including 5106 African American persons) free of cancer and cardiovascular disease at enrollment', 'individuals with low baseline ω-3 levels or for African American persons', 'Colorectal Adenomas and Serrated Polyps in the US General Population']","['fatty acid, 1 g daily (which included eicosapentaenoic acid, 460 mg, and docosahexaenoic acid, 380 mg) and vitamin D3', 'daily marine ω-3 supplements', 'daily marine ω-3 fatty acid supplementation', 'placebo', 'Supplementation With Marine ω-3 Fatty Acid']","['Measures\n\n\nRisk of conventional adenomas (including tubular adenoma, tubulovillous adenoma, villous adenoma, and adenoma with high-grade dysplasia) or serrated polyps (including hyperplastic polyp, traditional serrated adenoma, and sessile serrated polyp', 'Odds ratios (ORs']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0334292', 'cui_str': 'Tubular adenoma, no International Classification of Diseases for Oncology subtype (morphologic abnormality)'}, {'cui': 'C0334307', 'cui_str': 'Tubulovillous adenoma (morphologic abnormality)'}, {'cui': 'C0206674', 'cui_str': 'Adenoma, Villous'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0333983', 'cui_str': 'Metaplastic polyp (morphologic abnormality)'}, {'cui': 'C1266025', 'cui_str': 'Serrated adenoma'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated polyp'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",294.0,0.377871,"A beneficial association of supplementation was also noted in the African American population (OR, 0.59; 95% CI, 0.35-1.00) but not in other racial/ethnic groups (P = .11 for interaction).
","[{'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Dushkes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Mongan Institute, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Ogino', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2019.4587']
659,28866911,Cognitive-Behavioral Therapy for Adult ADHD: A Randomized Clinical Trial in China.,"OBJECTIVE


Cognitive-behavioral therapy (CBT) is effective for adult ADHD, and booster sessions may improve long-term outcome. This study was designed to investigate the effects of group CBT and its booster sessions for Chinese adult patients with ADHD.
METHOD


There were CBT only group ( n = 43), CBT +booster group ( n = 43), and control group with patients on the waiting list ( n = 22). The primary outcome was the score of the ADHD-Rating Scale (ADHD-RS). Secondary outcomes included emotion, executive function (EF), impulsivity, self-esteem, and life quality at 12th and 24th week.
RESULTS


At 12th week, the score of ADHD-RS, EF, and impulsivity showed significant improvement in CBT +booster group comparing with control group. At 24th week, differences between CBT only group and CBT +booster group were not significant.
CONCLUSION


CBT was effective for Chinese adult patients with ADHD. Booster sessions do not appear to provide additional benefits.",2019,"At 12th week, the score of ADHD-RS, EF, and impulsivity showed significant improvement in CBT +booster group comparing with control group.","['Chinese adult patients with ADHD', 'Adult ADHD']","['CBT', 'Cognitive-behavioral therapy (CBT', 'Cognitive-Behavioral Therapy']","['score of ADHD-RS, EF, and impulsivity', 'score of the ADHD-Rating Scale (ADHD-RS', 'emotion, executive function (EF), impulsivity, self-esteem, and life quality at 12th and 24th week']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0222045'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0034380'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",43.0,0.0298164,"At 12th week, the score of ADHD-RS, EF, and impulsivity showed significant improvement in CBT +booster group comparing with control group.","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Yi-Lang', 'Initials': 'YL', 'LastName': 'Tang', 'Affiliation': '3 Emory University, School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Mengjie', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Meirong', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}, {'ForeName': 'Qiujin', 'Initials': 'Q', 'LastName': 'Qian', 'Affiliation': '1 Peking University Sixth Hospital/Institute of Mental Health, National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.'}]",Journal of attention disorders,['10.1177/1087054717725874']
660,31144577,A proof-of-concept application of a novel scoring approach for personalized medicine in multiple sclerosis.,"BACKGROUND


Stratified medicine methodologies based on subgroup analyses are often insufficiently powered. More powerful personalized medicine approaches are based on continuous scores.
OBJECTIVE


We deployed a patient-specific continuous score predicting treatment response in patients with relapsing-remitting multiple sclerosis (RRMS).
METHODS


Data from two independent randomized controlled trials (RCTs) were used to build and validate an individual treatment response (ITR) score, regressing annualized relapse rates (ARRs) on a set of baseline predictors.
RESULTS


The ITR score for the combined treatment groups versus placebo detected differential clinical response in both RCTs. High responders in one RCT had a cross-validated ARR ratio of 0.29 (95% confidence interval (CI) = 0.13-0.55) versus 0.62 (95% CI = 0.47-0.83) for all other responders (heterogeneity  p  = 0.038) and were validated in the other RCT, with the corresponding ARR ratios of 0.31 (95% CI = 0.18-0.56) and 0.61 (95% CI = 0.47-0.79; heterogeneity  p  = 0.036). The strongest treatment effect modifiers were the Short Form-36 Physical Component Summary, age, Visual Function Test 2.5%, prior MS treatment and Expanded Disability Status Scale.
CONCLUSION


Our modelling strategy detects and validates an ITR score and opens up avenues for building treatment response calculators that are also applicable in routine clinical practice.",2020,"The strongest treatment effect modifiers were the Short Form-36 Physical Component Summary, age, Visual Function Test 2.5%, prior MS treatment and Expanded Disability Status Scale.
","['multiple sclerosis', 'patients with relapsing-remitting multiple sclerosis (RRMS']",['placebo'],"['Short Form-36 Physical Component Summary, age, Visual Function Test 2.5%, prior MS treatment and Expanded Disability Status Scale', 'ITR score', 'individual treatment response (ITR) score, regressing annualized relapse rates (ARRs', 'cross-validated ARR ratio']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.193088,"The strongest treatment effect modifiers were the Short Form-36 Physical Component Summary, age, Visual Function Test 2.5%, prior MS treatment and Expanded Disability Status Scale.
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pellegrini', 'Affiliation': 'Biogen International GmbH, Baar, Switzerland.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Copetti', 'Affiliation': 'Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bovis', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hyde', 'Affiliation': 'Biogen International GmbH, Baar, Switzerland.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'de Moor', 'Affiliation': 'Biogen Inc., Cambridge, MA, USA.'}, {'ForeName': 'Bernd C', 'Initials': 'BC', 'LastName': 'Kieseier', 'Affiliation': 'Biogen Inc., Cambridge, MA, USA; Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519849513']
661,31113007,"[Quality of Life and Satisfaction During the Diabetes Prevention Program GLICEMIA: a Cluster-Randomized, Controlled Trial].","OBJECTIVES


We aimed to assess the health-related quality of life as well as participant satisfaction during the pharmacy-based diabetes prevention program GLICEMIA.
METHODS


GLICEMIA comprises 3 individual counseling sessions and 5 group-based lectures addressing a lifestyle modification. In a cluster-randomized controlled trial, GLICEMIA was compared with reduced standard information in the control group. After 12 months, the groups were compared regarding the diabetes risk score FINDRISC, health-related quality of life with the 12-item Short Form health survey (SF-12) and participant satisfaction.
RESULTS


In total, the data of 1,087 participants were analyzed. During GLICEMIA, 38.9% reduced their FINDRISC whereas 20.9% reached this goal in the control group. Moreover, the physical quality of life improved significantly in the intervention group compared with the control group (adjusted effect size: 2.39 points, 95% CI 1.43-3.34). Participants of GLICEMIA who reduced their diabetes risk had enhanced mental and physical quality of life after one year. This was not observed in the control group. The overall benefit and satisfaction were rated very high in the intervention group.
CONCLUSION


Participation in GLICEMIA results in a significant reduction of the diabetes risk according to the FINDRISC, as well as an improved physical and mental quality of life. The high satisfaction of the participants reflects the overall benefit. Nationwide implementation of the program is recommended.",2020,"After 12 months, the groups were compared regarding the diabetes risk score FINDRISC, health-related quality of life with the 12-item Short Form health survey (SF-12) and participant satisfaction.
","['1,087 participants were analyzed']",['individual counseling sessions and 5 group-based lectures addressing a lifestyle modification'],"['physical quality of life', 'physical and mental quality of life', 'enhanced mental and physical quality of life', 'Quality of Life and Satisfaction', 'diabetes risk', 'overall benefit and satisfaction', 'diabetes risk score FINDRISC, health-related quality of life with the 12-item Short Form health survey (SF-12) and participant satisfaction']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",1087.0,0.0742749,"After 12 months, the groups were compared regarding the diabetes risk score FINDRISC, health-related quality of life with the 12-item Short Form health survey (SF-12) and participant satisfaction.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schmiedel', 'Affiliation': 'WIPIG - Wissenschaftliches Institut für Prävention im Gesundheitswesen der Bayerischen Landesapothekerkammer, München.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mayr', 'Affiliation': 'Institut für Medizinische Biometrie, Informatik und Epidemiologie, Medizinische Fakultät, Rheinische Friedrich Wilhelms Universität Bonn, Bonn.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Fießler', 'Affiliation': 'Institut für Medizininformatik, Biometrie und Epidemiologie, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schlager', 'Affiliation': 'WIPIG - Wissenschaftliches Institut für Prävention im Gesundheitswesen der Bayerischen Landesapothekerkammer, München.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Friedland', 'Affiliation': 'Institut für Pharmakologie und Toxilogie, Johannes-Gutenberg-Universität Mainz, Mainz.'}]",Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)),['10.1055/a-0883-4888']
662,31112605,Personality Moderates Intervention Effects on Cognitive Function: A 6-Week Conversation-Based Intervention.,"BACKGROUND AND OBJECTIVES


Social isolation is associated with a higher risk of dementia. We previously conducted and showed the efficacy of an intervention which uses conversation (the core component of social interactions) as a tool to enhance cognitive function. We now explore whether cognitive improvements through conversation-based intervention depend on an individual's personality.
RESEARCH DESIGN AND METHODS


We reexamined data from a 6-week randomized controlled trial (ClinicalTrials.gov Number: NCT01571427) to determine whether conversation-based intervention effects were moderated by personality traits in 83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment). The intervention group participated in daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks. At baseline, psychosocial questionnaires and a neuropsychological battery were completed.
RESULTS


Intervention group participants with high agreeableness, conscientiousness, and extraversion exhibited significant improvements in language-based executive function tasks beyond changes in the control group (ps < .05). An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
DISCUSSION AND IMPLICATIONS


Our exploratory findings suggest the adaptive role of personality traits in conversation-based cognitive interventions may be limited to tasks incorporating a language component, and offer initial evidence for personalized approaches to cognitive health in late life.",2020,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","['83 older adults (mean age = 80.51 years, 49 cognitively intact, 34 individuals with mild cognitive impairment']",['daily 30-min face-to-face semi-structured conversations with trained interviewers through a web-enabled system for 6 weeks'],"['language-based executive function tasks', 'Cognitive Function', 'delayed recall memory and working memory tasks']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",83.0,0.0918085,"An opposite pattern for delayed recall memory and working memory tasks emerged among highly extraverted participants (ps < .05).
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Cerino', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hooker', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Goodrich', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}, {'ForeName': 'Hiroko H', 'Initials': 'HH', 'LastName': 'Dodge', 'Affiliation': ""Department of Neurology, Layton Aging and Alzheimer's Disease Center, Oregon Health and Science University, Portland.""}]",The Gerontologist,['10.1093/geront/gnz063']
663,31138037,Effects of Sleep Extension on Inhibitory Control in Children With ADHD: A Pilot Study.,"Objective:  Children with ADHD often have sleep complaints and cognitive deficits. The aim of this pilot study was to determine whether sleep extension improves inhibitory control, a primary cognitive deficit in ADHD.  Method:  Children with ( n  = 11) and without ( n  = 15) ADHD participated in a within-subject sleep extension intervention that targeted nocturnal sleep duration. Sleep was assessed with actigraphy and polysomnography. Inhibitory control was assessed with a Go/No-Go task.  Results:  For children without ADHD, there was a significant main effect of time, such that morning inhibitory control was 10% greater than evening inhibitory control. However, inhibitory control did not differ between the baseline and extension conditions in this group. For children with ADHD, although morning inhibitory control did not differ from evening inhibitory control, sleep extension improved inhibitory control by 13% overall.  Conclusion:  These results suggest that a sleep extension intervention improves inhibitory control in children with ADHD.",2020,"For children with ADHD, although morning inhibitory control did not differ from evening inhibitory control, sleep extension improved inhibitory control by 13% overall.
","['Children With ADHD', 'children with ADHD', 'Children with ADHD often have sleep complaints and cognitive deficits', 'Children with ( n = 11) and without ( n = 15) ADHD participated in a']","['Sleep Extension', 'within-subject sleep extension intervention that targeted nocturnal sleep duration', 'sleep extension intervention']",['Sleep'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",15.0,0.0214112,"For children with ADHD, although morning inhibitory control did not differ from evening inhibitory control, sleep extension improved inhibitory control by 13% overall.
","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cremone-Caira', 'Affiliation': 'University of Massachusetts Amherst, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Root', 'Affiliation': 'University of Massachusetts Amherst, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Harvey', 'Affiliation': 'University of Massachusetts Amherst, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'McDermott', 'Affiliation': 'University of Massachusetts Amherst, USA.'}, {'ForeName': 'Rebecca M C', 'Initials': 'RMC', 'LastName': 'Spencer', 'Affiliation': 'University of Massachusetts Amherst, USA.'}]",Journal of attention disorders,['10.1177/1087054719851575']
664,31678952,Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health.,"INTRODUCTION


Stroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke.
METHODS AND ANALYSIS


The proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods.
ETHICS AND DISSEMINATION


The study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences.
TRIAL REGISTRATION NUMBER


NCT03730701.",2019,"Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies.","['Persons at risk of stroke (n=60', 'persons at risk of stroke']",['combining group meetings and online resources to support self-management of lifestyle change'],"['stroke risk, lifestyle habits and healthy activity patterns']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0789784,"Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies.","[{'ForeName': 'Ann-Helen', 'Initials': 'AH', 'LastName': 'Patomella', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden ann-helen.patomella@ki.se.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Guidetti', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Emelie', 'Initials': 'E', 'LastName': 'Mälstam', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Eriksson', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Bergström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Åkesson', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kottorp', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Asaba', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-031984']
665,31135580,Effect of Visual Aids During Surgical Consents on Patient Understanding and Satisfaction.,"OBJECTIVE


This study aimed to assess whether the use of visual aids to augment the consent process for pelvic floor surgeries affects patient understanding and satisfaction.
METHODS


We conducted a single-blind, randomized controlled trial. Adults planning robotic sacrocolpopexy or suburethral sling surgeries were eligible. All participants received standard preoperative consent counseling. Participants randomized to the intervention also viewed slides with visual aids that paralleled standard counseling; participants randomized to the control group received only standard counseling. All participants completed surveys after their preoperative visit, the day of surgery, and at their postoperative visit. Each survey contained 12 true-false questions about risks, benefits, and alternatives of surgery, and expectations during recovery. The primary outcome was the percentage of correct true-false questions. We conducted an intention-to-treat analysis.
RESULTS


We randomized 32 participants undergoing robotic sacrocolpopexy and 32 undergoing suburethral sling surgeries, yielding 16 in the intervention group and 16 in the control group for each procedure. The intervention and control groups for both surgeries were similar in age, body mass index, race, education, and previous surgery for similar symptoms.Among participants undergoing robotic sacrocolpopexies, median knowledge scores at the preoperative visit were similar between the intervention (92% [interquartile range {IQR}, 86%-100%]) and control (86% [IQR, 75%-94%]) groups (P = 0.21). Similar results were seen for participants undergoing suburethral sling procedures in the intervention (83.3% [IQR, 71%-92%]) and control (83% [IQR, 75%-88%]) groups (P = 0.64).
CONCLUSIONS


We found that using visual aids during the consent process for patients undergoing robotic sacrocolpopexy or suburethral sling surgeries did not improve knowledge.",2019,Participants randomized to the intervention also viewed slides with visual aids that paralleled standard counseling; participants randomized to the control group received only standard counseling.,"['Adults planning robotic sacrocolpopexy or suburethral sling surgeries were eligible', '32 participants undergoing', 'patients undergoing robotic sacrocolpopexy or suburethral sling surgeries']","['robotic sacrocolpopexy', 'Visual Aids', 'standard preoperative consent counseling', 'control group received only standard counseling', 'suburethral sling surgeries', 'visual aids', 'intervention also viewed slides with visual aids that paralleled standard counseling']","['median knowledge scores', 'percentage of correct true-false questions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C1721082', 'cui_str': 'Suburethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721082', 'cui_str': 'Suburethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0344218', 'cui_str': 'Visual aid (procedure)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",32.0,0.115902,Participants randomized to the intervention also viewed slides with visual aids that paralleled standard counseling; participants randomized to the control group received only standard counseling.,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Haviland', 'Affiliation': ''}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Hacker', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Lefevre', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000703']
666,31116102,Rumination syndrome: when to suspect and how to treat.,"PURPOSE OF REVIEW


Rumination syndrome is a gastrointestinal disorder characterized by effortless regurgitation of recently ingested food. The disorder is rare, but likely under-recognized and leads to impaired quality of life among those affected. This review discusses recent studies which examined the pathophysiology, diagnoses and therapy of rumination syndrome.
RECENT FINDINGS


The pathogenesis of rumination syndrome remains incompletely understood. Therapeutic options, which appear effective, include behavioral therapy with diaphragmatic breathing and pharmacotherapy with baclofen. A randomized trial of behavioral therapy, biofeedback therapy led to a 74% + /- 6% reduction in rumination activity (from 29  + /- 6 before to 7 + /- 2 daily events after intervention) vs. 1% + /- 14% during sham (from 21 + /- 2 before to 21 + /- 4 daily events after intervention) (P = .001). A recent randomized trial of baclofen at a dose of 10 mg three times daily led to symptomatic improvement in 63% of patients with rumination syndrome.
SUMMARY


This review summarizes a clinical approach to diagnosing and treating rumination syndrome. Behavioral therapy consisting of diaphragmatic breathing, with or without biofeedback, remains the most effective treatment strategy for patients with rumination syndrome.",2019,"Behavioral therapy consisting of diaphragmatic breathing, with or without biofeedback, remains the most effective treatment strategy for patients with rumination syndrome.","['63% of patients with rumination syndrome', 'patients with rumination syndrome']","['baclofen', 'diaphragmatic breathing and pharmacotherapy with baclofen', 'behavioral therapy, biofeedback therapy led to a 74%\u200a+\u200a', 'Behavioral therapy consisting of diaphragmatic breathing, with or without biofeedback']","['rumination activity', 'Rumination syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",,0.0191799,"Behavioral therapy consisting of diaphragmatic breathing, with or without biofeedback, remains the most effective treatment strategy for patients with rumination syndrome.","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Halland', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Current opinion in gastroenterology,['10.1097/MOG.0000000000000549']
667,31850996,The Influence of Perioperative Fluid Therapy on N-terminal-pro-brain Natriuretic Peptide and the Association With Heart and Lung Complications in Patients Undergoing Colorectal Surgery: Secondary Results of a Clinical Randomized Assessor-blinded Multicenter Trial.,"OBJECTIVE


To investigate the influence of intravenous (iv) fluid volumes on the secretion of N-terminal-pro-brain natriuretic peptide (NT-Pro-BNP) in colorectal surgical patients and its association with cardiopulmonary complications (CPC). In addition, to examine if preoperative NT-Pro-BNP can predict the risk for postoperative CPC.
METHODS


Blood samples from patients enrolled in a previously published clinical randomized assessor-blinded multicenter trial were analyzed. Included were adult patients undergoing elective colorectal surgery with the American-Society-of-Anesthesiologists-scores of 1-3. Samples from 135 patients were available for analysis. Patients were allocated to either a restrictive (R-group) or a standard (S-group) iv-fluid regimen, commencing preoperatively and continuing until discharge. Blood was sampled every morning until the fourth postoperative day. The primary outcome for this study was NT-Pro-BNP changes and its association with fluid therapy and CPC.
RESULTS


The S-group received more iv-fluid than the R-group on the day-of-surgery [milliliter, median (range) 6485 (4401-10750) vs 3730 (2250-8510); P < 0.001] and on the first postoperative day. NT-Pro-BNP was elevated in the S-group compared with the R-group on all postoperative days [area under the curve: median (interquartile range) pg/mL: 3285 (1697-6179) vs 1290 (758-3719); P < 0.001 and in patients developing CPC vs no-CPC (area under the curve), median (interquartile range): 5196 (1823-9061) vs 1934 (831-5301); P = 0.005]. NT-pro-BNP increased with increasing fluid volumes all days (P < 0.003). Preoperative NT-Pro-BNP predicted CPC [odds ratio (confidence interval): 1.573 (0.973-2.541), P = 0.032; positive predictive value = 0.257, negative predictive value = 0.929].
CONCLUSIONS


NT-pro-BNP increases with iv-fluid volumes given to colorectal surgical patients, and the level of NT-Pro-BNP is associated with CPC. Preoperative NT-Pro-BNP is predictive for CPC, but the diagnostic value is low.Clinicaltrials.gov NCT03537989.",2020,NT-Pro-BNP was elevated in the S-group compared with the R-group on all postoperative days [area under the curve: median (interquartile range) pg/mL:,"['colorectal surgical patients and its association with cardiopulmonary complications (CPC', 'adult patients undergoing elective colorectal surgery with the American-Society-of-Anesthesiologists-scores of 1-3', '135 patients were available for analysis', 'Blood samples from patients enrolled in a previously published clinical randomized assessor-blinded multicenter trial were analyzed', 'Patients Undergoing Colorectal Surgery']","['restrictive (R-group) or a standard (S-group) iv-fluid regimen', 'intravenous (iv) fluid volumes', 'Perioperative Fluid Therapy']","['NT-Pro-BNP changes and its association with fluid therapy and CPC', 'NT-Pro-BNP', 'NT-pro-BNP']","[{'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}]",,0.208785,NT-Pro-BNP was elevated in the S-group compared with the R-group on all postoperative days [area under the curve: median (interquartile range) pg/mL:,"[{'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brandstrup', 'Affiliation': 'Department of Surgery, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Beier-Holgersen', 'Affiliation': 'Department of Surgery, Nordsjællands Hospital Hillerød, Hillerød, Denmark.'}, {'ForeName': 'Lene H', 'Initials': 'LH', 'LastName': 'Iversen', 'Affiliation': 'Department of Surgery, Aahus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Starup', 'Affiliation': 'Niels Bohr Institute, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Loui N', 'Initials': 'LN', 'LastName': 'Wentzel', 'Affiliation': 'Niels Bohr Institute, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lindorff-Larsen', 'Affiliation': 'NordSim, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Troels C', 'Initials': 'TC', 'LastName': 'Petersen', 'Affiliation': 'Niels Bohr Institute, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Tønnesen', 'Affiliation': 'WHO-CC, Bispebjerg-Frederiksberg Hospital, Copenhagen University, Frederiksberg, Denmark.'}]",Annals of surgery,['10.1097/SLA.0000000000003724']
668,31081360,"Does red orange juice supplementation has a protective effect on performance, cardiovascular parameters, muscle damage and oxidative stress markers following the Yo-Yo Intermittent Recovery Test Level-1 under polluted air?","This study aimed to investigate the effect of red orange juice supplementation (ROJS) on performance, cardiovascular parameters, muscle damage and oxidative stress markers of athletes following exercise under polluted air. Eleven soccer players performed a Yo-Yo Intermittent Recovery Test Level-1 in polluted area (PA) and non-polluted area (NPA). Participants are invited to drink 500 ml of red orange or placebo (PLA) juice 2.5 h before the test. Blood samples were collected at rest and 3 min after each session to assess creatine kinase (CK), lactate dehydrogenase, malondialdehyde (MDA) and total antioxidant status. Our results showed that, VO 2max , heart rate and systolic blood pressure post-exercise were significantly altered by pollution with both supplements, but the damage was lowered more with ROJS than PLA. Concerning muscle damage and oxidative stress markers, orange juice supplementation blunted the effect of pollution on CK levels post-exercise ( p  > 0.05) and decreases significantly ( p  < 0.05) the MDA levels post-exercise in PA and NPA compared to PLA supplementation. In conclusion, ROJS seemed to be an appropriate strategy to reduce the risk of exposure to pollution especially on muscle damage and oxidative stress markers.",2020,"Concerning muscle damage and oxidative stress markers, orange juice supplementation blunted the effect of pollution on CK levels post-exercise (p > 0.05) and decreases significantly (p < 0.05) the MDA levels post-exercise in PA and NPA compared to PLA supplementation.","['Eleven soccer players performed a Yo-Yo Intermittent Recovery Test Level-1 in polluted area (PA) and non-polluted area (NPA', 'athletes following exercise under polluted air']","['drink 500\xa0ml of red orange or placebo (PLA) juice', 'red orange juice supplementation (ROJS', 'red orange juice supplementation']","['Blood samples', 'VO 2max , heart rate and systolic blood pressure post-exercise', 'CK levels post-exercise', 'performance, cardiovascular parameters, muscle damage and oxidative stress markers', 'creatine kinase (CK), lactate dehydrogenase, malondialdehyde (MDA) and total antioxidant status']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0001873', 'cui_str': 'Air Pollution'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.230688,"Concerning muscle damage and oxidative stress markers, orange juice supplementation blunted the effect of pollution on CK levels post-exercise (p > 0.05) and decreases significantly (p < 0.05) the MDA levels post-exercise in PA and NPA compared to PLA supplementation.","[{'ForeName': 'Nesrine', 'Initials': 'N', 'LastName': 'Boussetta', 'Affiliation': 'High Institute of Sport and Physical Education, University of Manouba , Manouba, Tunisia.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Abedelmalek', 'Affiliation': 'Department of Physiology and functional explorations, Sousse Faculty of Medicine, University of Sousse , Sousse, Tunisia.'}, {'ForeName': 'Aloui', 'Initials': 'A', 'LastName': 'Khouloud', 'Affiliation': 'Faculty of Sciences of Bizerte, University of Carthage , Bizerte, Tunisia.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Ben Anes', 'Affiliation': 'Research Unit UR12ES06, Physiology of Exercise and Physiopathology: from Integrated to Molecular ""Biology, Medicine and Health"", Faculty of Medicine of Sousse, University of Sousse , Sousse, Tunisia.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Souissi', 'Affiliation': 'High Institute of Sport and Physical Education, University of Manouba , Manouba, Tunisia.'}]",International journal of environmental health research,['10.1080/09603123.2019.1614155']
669,31740072,"Long-term Oncological Outcomes from an Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL).","BACKGROUND


The long-term oncological outcomes of laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC) are still maturing compared with open radical cystectomy (ORC).
OBJECTIVE


To evaluate the 5-yr oncological outcomes of patients recruited into the randomised trial of Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion.
DESIGN, SETTING, AND PARTICIPANTS


A review of prospectively maintained database of 60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC) who were previously randomised in the CORAL trial to receive ORC, RARC, or LRC. This trial was designed to compare the perioperative and early oncological outcomes of these techniques.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcomes of interest included 5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). Kaplan-Meier curves were used to plot the recurrence and survival data. The curves between RFS, CSS, and OS were compared using the log-rank test. A two-sided p value <0.05 was considered significant. Results were analysed on the basis of intention to treat.
RESULTS AND LIMITATIONS


A total of 60 patients with either MIBC (n=38) or HRNMIBC (n=21) were randomised in the CORAL trial to receive ORC, RARC, or LRC. The 5-yr RFS was 60%, 58%, and 71%; 5-yr CSS was 64%, 68%, and 69%; and 5-yr OS was 55%, 65%, and 61% for ORC, RARC, and LRC, respectively. There was no significant difference in RFS, CSS, and OS between the three surgical arms. The principal limitation is the small sample size.
CONCLUSIONS


There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer. Minimally invasive techniques achieved equivalent oncological outcomes to the gold standard of ORC. However, the study was based at a single institution with a small sample size.
PATIENT SUMMARY


Patients who agreed to participate in the randomised trial of either open, laparoscopic, or robotic-assisted radical cystectomy for bladder cancer did not have different cancer outcomes at 5yr.",2020,"There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer.","['60 patients with either MIBC (n=38) or HRNMIBC (n=21', '60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC']","['Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion', 'ORC, RARC, or LRC', 'Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL', 'open, laparoscopic, or robotic-assisted radical cystectomy', 'open radical cystectomy (ORC', 'laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC']","['5-yr CSS', 'curves between RFS, CSS, and OS', 'RFS, CSS, and OS', 'equivalent oncological outcomes', '5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS', '5-yr RFS, CSS, and OS rates', '5-yr OS', '5-yr RFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0042020', 'cui_str': 'Urinary Diversion'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}, {'cui': 'C0324034', 'cui_str': 'Coral'}]","[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.280624,"There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer.","[{'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, King's College London, London, UK. Electronic address: shamim.khan@gstt.nhs.uk.""}, {'ForeName': 'Kawa', 'Initials': 'K', 'LastName': 'Omar', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK; Department of Urology, King's College Hospital, Denmark Hill, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gan', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""King's College London, School of Cancer and Pharmaceutical Studies, Translational Oncology & Urology Research (TOUR), London, UK.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Thurairaja', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rimington', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Urology, Guy's & St Thomas' NHS Foundation Trust, London, UK; MRC Centre for Transplantation, King's College London, London, UK.""}]",European urology,['10.1016/j.eururo.2019.10.027']
670,31748505,Effects of cannabidivarin (CBDV) on brain excitation and inhibition systems in adults with and without Autism Spectrum Disorder (ASD): a single dose trial during magnetic resonance spectroscopy.,"Autism spectrum disorder (ASD) is a high cost neurodevelopmental condition; and there are currently no effective pharmacological treatments for its core symptoms. This has led some families and researchers to trial alternative remedies - including the non-intoxicating Cannabis sativa-derived compound cannabidivarin (CBDV). However, how CBDV affects the human brain is unknown. Previous (pre)clinical evidence suggests that CBDV may modulate brain excitatory-inhibitory systems, which are implicated in ASD. Hence, our main aim was to test, for the first time, if CBDV shifts glutamate and/or GABA metabolites - markers of the brain's primary excitatory and inhibitory system - in both the 'typical' and autistic brain. Our subsidiary aim was to determine whether, within ASD, brain responsivity to CBDV challenge is related to baseline biological phenotype. We tested this using a repeated-measures, double-blind, randomized-order, cross-over design. We used magnetic resonance spectroscopy (MRS) to compare glutamate (Glx = glutamate + glutamine) and GABA + (GABA + macromolecules) levels following placebo (baseline) and 600 mg CBDV in 34 healthy men with (n = 17) and without (n = 17) ASD. Data acquisition from regions previously reliably linked to ASD (dorsomedial prefrontal cortex, DMPFC; left basal ganglia, BG) commenced 2 h (peak plasma levels) after placebo/CBDV administration. Where CBDV significantly shifted metabolite levels, we examined the relationship of this change with baseline metabolite levels. Test sessions were at least 13 days apart to ensure CBDV wash-out. CBDV significantly increased Glx in the BG of both groups. However, this impact was not uniform across individuals. In the ASD group, and not in the typically developing controls, the 'shift' in Glx correlated negatively with baseline Glx concentration. In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group. Our findings suggest that, as measured by MRS, CBDV modulates the glutamate-GABA system in the BG but not in frontal regions. Moreover, there is individual variation in response depending on baseline biochemistry. Future studies should examine the effect of CBDV on behaviour and if the response to an acute dose of CBDV could predict a potential clinical treatment response in ASD.",2019,"In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group.","['34 healthy men with (n\u2009=\u200917) and without (n\u2009=\u200917) ASD', 'adults with and without Autism Spectrum Disorder (ASD', 'Autism spectrum disorder (ASD']","['placebo (baseline) and 600\u2009mg CBDV', 'cannabidivarin (CBDV', 'magnetic resonance spectroscopy (MRS) to compare glutamate (Glx\u2009=\u2009glutamate\u2009+\u2009glutamine) and GABA\u2009+\u2009(GABA', 'magnetic resonance spectroscopy']",['brain excitation and inhibition systems'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3657549', 'cui_str': 'CBDV compound'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",34.0,0.290473,"In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group.","[{'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Pretzsch', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Voinescu', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Horder', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria Andreina', 'Initials': 'MA', 'LastName': 'Mendez', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ajram', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ivin', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heasman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russel H Morgan Department of Radiology and Radiological Science, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Declan G M', 'Initials': 'DGM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gráinne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. grainne.mcalonan@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-019-0654-8']
671,31912285,EQ-5D-5L questionnaire as suitable assessment of quality of life after epiduroscopy : Multicenter randomized double-blind pilot study.,"BACKGROUND


Epiduroscopy is a well-established diagnostic and to certain level therapeutic tool in complex situations, where conventional methods such as magnetic resonance imaging (MRI) lack power or resolution to detect pathological changes. Such a situation is primarily failed back surgery syndrome (FBSS) but also radicular pain without surgery. The aim of this study was to determine the effectiveness of epiduroscopic treatment in patients with FBSS.
METHODS


A total of 79 patients with FBSS were randomized into 2 groups. The first group underwent epiduroscopy and received mechanical lysis of adhesions only, the second group received also medication into the epidural space (methylprednisolone and hyaluronidase). Patients were subsequently followed for 12 months, with evaluation also after 6 months post-epiduroscopy. Patients were checked in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression as defined in the 5‑dimensional EQ-5D-5L questionnaire and to asses suitability of this questionnaire in chronic pain states. Data were collected using EQ-5D-5L questionnaire and also quality of life (QoL) questionnaire.
RESULTS


In the terms of ability to walk (dimension mobility) and also ability to do housework, study or leisure activities (dimension usual activity) patients improved in both groups after 6 and 12 months after epiduroscopy. In pain dimension there was improvement mainly after 6 months which correlated also with self-care dimension and quality of life self-assessment. Results in anxiety/depression dimension were mixed.
CONCLUSION


Epiduroscopy appears to be a beneficial procedure for both patient groups, especially after 6 months, with some benefit remaining after 12 months. The EQ-5D-5L questionnaire seems to be a suitable and comprehensive way to assess patient health in chronic pain states.",2020,"Patients were checked in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression as defined in the 5‑dimensional EQ-5D-5L questionnaire and to asses suitability of this questionnaire in chronic pain states.","['patients with FBSS', '79\xa0patients with FBSS']","['EQ-5D-5L questionnaire', 'mechanical lysis of adhesions only, the second group received also medication into the epidural space (methylprednisolone and hyaluronidase', 'epiduroscopic', 'epiduroscopy']","['mobility, self-care, usual activities, pain/discomfort and anxiety/depression', 'quality of life', 'EQ-5D-5L questionnaire and also quality of life (QoL) questionnaire', 'self-care dimension and quality of life self-assessment', 'anxiety/depression dimension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0228134', 'cui_str': 'Epidural Space'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0877073', 'cui_str': 'Epiduroscopy'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",,0.0531958,"Patients were checked in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression as defined in the 5‑dimensional EQ-5D-5L questionnaire and to asses suitability of this questionnaire in chronic pain states.","[{'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Rapčan', 'Affiliation': 'Europainclinics, Kominárska 21/5, 831 04, Bratislava, Slovakia.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Kočan', 'Affiliation': 'Clinic of Anaesthesiology and Intensive Care Medicine, East Slovak Institute of Cardiovascular Disease, Ondavská\xa08, 040 11, Košice, Slovakia.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Witkovsky', 'Affiliation': 'Institute of Measurement Science, Slovak Academy of Sciences, Dúbravská cesta\xa09, 841 04, Bratislava, Slovakia.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Mláka', 'Affiliation': 'Poliklinika Terasa, Europainclinics, Toryská\xa01, 040 11, Košice, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Griger', 'Affiliation': 'Europainclinics, Kominárska 21/5, 831 04, Bratislava, Slovakia.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Burianek', 'Affiliation': 'Europainclinics, Starochodovská\xa01750, 149 00, Prague 4, Czech Republic.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rapčanová', 'Affiliation': 'Europainclinics, Starochodovská\xa01750, 149 00, Prague 4, Czech Republic.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Kent Institute of Medicine and Surgery, Newnham Court Way, ME14 5FT, Bearsted, Kent, UK.'}, {'ForeName': 'Ľubomír', 'Initials': 'Ľ', 'LastName': 'Poliak', 'Affiliation': 'Europainclinics, Kominárska 21/5, 831 04, Bratislava, Slovakia.'}, {'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Tirpák', 'Affiliation': 'Department of Cardiac Surgery, East Slovak Institute of Cardiovascular Disease, Ondavská\xa08, 040 11, Košice, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Šimonová', 'Affiliation': '1st Clinic of Anaesthesiology and Intensive Care Medicine, Louis Pasteur University Hospital, SNP\xa01, 040 11, Košice, Slovakia.'}, {'ForeName': 'František', 'Initials': 'F', 'LastName': 'Sabol', 'Affiliation': 'Department of Cardiac Surgery, East Slovak Institute of Cardiovascular Disease, Ondavská\xa08, 040 11, Košice, Slovakia.'}, {'ForeName': 'Janka', 'Initials': 'J', 'LastName': 'Vašková', 'Affiliation': 'Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University, Trieda SNP\xa01, 040 66, Košice, Slovakia. janka.vaskova@upjs.sk.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-019-01590-z']
672,31112379,Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease.,"BACKGROUND


Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death. Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and antiinflammatory effects in preclinical models of systemic sclerosis and ILD.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of nintedanib in patients with ILD associated with systemic sclerosis. Patients who had systemic sclerosis with an onset of the first non-Raynaud's symptom within the past 7 years and a high-resolution computed tomographic scan that showed fibrosis affecting at least 10% of the lungs were randomly assigned, in a 1:1 ratio, to receive 150 mg of nintedanib, administered orally twice daily, or placebo. The primary end point was the annual rate of decline in forced vital capacity (FVC), assessed over a 52-week period. Key secondary end points were absolute changes from baseline in the modified Rodnan skin score and in the total score on the St. George's Respiratory Questionnaire (SGRQ) at week 52.
RESULTS


A total of 576 patients received at least one dose of nintedanib or placebo; 51.9% had diffuse cutaneous systemic sclerosis, and 48.4% were receiving mycophenolate at baseline. In the primary end-point analysis, the adjusted annual rate of change in FVC was -52.4 ml per year in the nintedanib group and -93.3 ml per year in the placebo group (difference, 41.0 ml per year; 95% confidence interval [CI], 2.9 to 79.0; P = 0.04). Sensitivity analyses based on multiple imputation for missing data yielded P values for the primary end point ranging from 0.06 to 0.10. The change from baseline in the modified Rodnan skin score and the total score on the SGRQ at week 52 did not differ significantly between the trial groups, with differences of -0.21 (95% CI, -0.94 to 0.53; P = 0.58) and 1.69 (95% CI, -0.73 to 4.12 [not adjusted for multiple comparisons]), respectively. Diarrhea, the most common adverse event, was reported in 75.7% of the patients in the nintedanib group and in 31.6% of those in the placebo group.
CONCLUSIONS


Among patients with ILD associated with systemic sclerosis, the annual rate of decline in FVC was lower with nintedanib than with placebo; no clinical benefit of nintedanib was observed for other manifestations of systemic sclerosis. The adverse-event profile of nintedanib observed in this trial was similar to that observed in patients with idiopathic pulmonary fibrosis; gastrointestinal adverse events, including diarrhea, were more common with nintedanib than with placebo. (Funded by Boehringer Ingelheim; SENSCIS ClinicalTrials.gov number, NCT02597933.).",2019,"The change from baseline in the modified Rodnan skin score and the total score on the SGRQ at week 52 did not differ significantly between the trial groups, with differences of -0.21 (95% CI, -0.94 to 0.53; P = 0.58) and 1.69 (95% CI, -0.73 to 4.12 [not adjusted for multiple comparisons]), respectively.","[""Patients who had systemic sclerosis with an onset of the first non-Raynaud's symptom within the past 7 years and a high-resolution computed tomographic scan that showed fibrosis affecting at least 10% of the lungs"", '576 patients', 'patients with idiopathic pulmonary fibrosis', 'patients with ILD associated with systemic sclerosis']","['nintedanib, administered orally twice daily, or placebo', 'placebo', 'mycophenolate', 'nintedanib or placebo', 'nintedanib']","['Diarrhea', 'annual rate of decline in FVC', 'diffuse cutaneous systemic sclerosis', 'annual rate of decline in forced vital capacity (FVC', 'adjusted annual rate of change in FVC', 'adverse-event profile of nintedanib', ""modified Rodnan skin score and in the total score on the St. George's Respiratory Questionnaire (SGRQ"", 'efficacy and safety', 'diarrhea', 'modified Rodnan skin score and the total score on the SGRQ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0034734', 'cui_str': 'Raynaud Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1258104', 'cui_str': 'Diffuse Systemic Sclerosis'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",576.0,0.717112,"The change from baseline in the modified Rodnan skin score and the total score on the SGRQ at week 52 did not differ significantly between the trial groups, with differences of -0.21 (95% CI, -0.94 to 0.53; P = 0.58) and 1.69 (95% CI, -0.73 to 4.12 [not adjusted for multiple comparisons]), respectively.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Kristin B', 'Initials': 'KB', 'LastName': 'Highland', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gahlemann', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Sauter', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Mannaig', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Margarida', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Clerisme-Beaty', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tetzlaff', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'From the Department of Rheumatology, University Hospital Zurich, Zurich (O.D.), and Boehringer Ingelheim (Schweiz), Basel (M. Gahlemann) - both in Switzerland; the Respiratory Institute, Cleveland Clinic, Cleveland (K.B.H.); the Departments of Pulmonary Medicine and Oncology (A.A.) and Allergy and Rheumatology (M.K.), Nippon Medical School Graduate School of Medicine, Tokyo; University of Colorado School of Medicine, Aurora (A.F.); the Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston (M.D.M.); University of Washington, Seattle (G.R.); Boehringer Ingelheim Pharma, Biberach an der Riss (W.S.), Boehringer Ingelheim International, Ingelheim am Rhein (M.A., E.C.-B., S.S., K.T.), and the Department of Sports Medicine, University of Tübingen, Tübingen (K.T.) - all in Germany; Boehringer Ingelheim France, Reims, France (M. Girard); and the National Heart and Lung Institute, Imperial College London, and the National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London (T.M.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1903076']
673,15100337,"Effectiveness of implementing the agency for healthcare research and quality smoking cessation clinical practice guideline: a randomized, controlled trial.","BACKGROUND


The Agency for Healthcare Research and Quality (AHRQ) Smoking Cessation Clinical Practice Guideline recommends that all clinicians strongly advise their patients who use tobacco to quit.
METHODS


We conducted a randomized, controlled trial of the effectiveness of Guideline implementation at eight community-based primary care clinics in southern Wisconsin (four test sites, four control sites) among 2163 consecutively enrolled adult patients who smoked at least one cigarette per day and presented for nonemergency care during the baseline period (June 16, 1999, to June 20, 2000) or the intervention period (from June 21, 2000, to May 3, 2001). After collecting baseline data, staff at test sites implemented the intervention over a 2-month period. The intervention included a tutorial for intake clinicians, group and individual performance feedback for intake clinicians, use of a modified vital signs stamp, an offer of free nicotine replacement therapy, and proactive telephone counseling. Staff at control sites received only general information about the AHRQ Guideline. Self-reported abstinence from smoking was determined by telephone interviews at 2- and 6-month follow-up assessments. Hierarchical logistic regression models were used to estimate the odds ratios (ORs) for treatment assignment after adjustment for patient characteristics. All statistical tests were two-sided.
RESULTS


There were no statistically significant differences in smoking cessation rates between participants at test and control sites during the baseline period. Among participants treated during the intervention period, those at test sites were more likely than those at control sites to report being abstinent at the 2-month (16.4% versus 5.8%; adjusted OR = 3.3, 95% confidence interval [CI] = 1.9 to 5.6; P<.001) and 6-month (15.4% versus 9.8%; adjusted OR = 1.7, 95% CI = 1.2 to 2.6; P =.009) follow-up assessments and to report continuous abstinence, that is, abstinence at both 2 and 6 months (10.9% versus 3.8%; adjusted OR = 3.4, 95% CI = 1.8 to 6.3; P<.001).
CONCLUSION


Implementation of a guideline-based smoking cessation intervention by intake clinicians in primary care is associated with higher abstinence among smokers.",2004,"CONCLUSION


Implementation of a guideline-based smoking cessation intervention by intake clinicians in primary care is associated with higher abstinence among smokers.","['patients who use tobacco to quit', 'at eight community-based primary care clinics in southern Wisconsin (four test sites, four control sites) among 2163 consecutively enrolled adult patients who smoked at least one cigarette per day and presented for nonemergency care during the baseline period (June 16, 1999, to June 20, 2000) or the intervention period (from June 21, 2000, to May 3, 2001']","['guideline-based smoking cessation intervention', 'nicotine replacement therapy, and proactive telephone counseling', 'Guideline implementation']","['smoking cessation rates', 'Quality (AHRQ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",2163.0,0.0337654,"CONCLUSION


Implementation of a guideline-based smoking cessation intervention by intake clinicians in primary care is associated with higher abstinence among smokers.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, USA.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Muehlenbruch', 'Affiliation': ''}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': ''}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,[]
674,31747018,"Sex-related differences in risk factors, outcome, and quality of life in patients with permanent atrial fibrillation: results from the RACE II study.","AIMS


Atrial fibrillation (AF) risk factors translate into disease progression. Whether this affects women and men differently is unclear. We aimed to investigate sex differences in risk factors, outcome, and quality of life (QoL) in permanent AF patients.
METHODS AND RESULTS


The Rate Control Efficacy in Permanent Atrial Fibrillation (RACE II) randomized 614 patients, 211 women and 403 men, to lenient or strict rate control. In this post hoc analysis risk factors, cardiovascular events during 3-year follow-up (cardiovascular death, heart failure hospitalization, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events), outcome parameters, and QoL were compared between the sexes. Women were older (71 ± 7 vs. 66 ± 8 years, P < 0.001), had more hypertension (70 vs. 57%, P = 0.002), and heart failure with preserved ejection fraction (36 vs. 17%, P < 0.001), but less coronary artery disease (13 vs. 21%, P = 0.02). Women had more risk factors (3.7 ± 1.2 vs. 2.9 ± 1.4, P < 0.001) Cardiovascular events occurred in 46 (22%) women and 59 (15%) men (P = 0.03). Women had a 1.52 times [95% confidence interval (CI) 1.03-2.24] higher yearly cardiovascular event-rate [8.2% (6.0-10.9) vs. 5.4% (4.1-6.9), P = 0.03], but this was no longer significant after adjusting for the number of underlying risk factors. Women had reduced QoL, irrespective of age and heart rate but negatively influenced by their risk factors.
CONCLUSION


In this permanent AF population, women had more accumulation of AF risk factors than men. The observed higher cardiovascular event rate in women was no longer significant after adjusting for the number of risk factors. Further, QoL was negatively influenced by the higher number of risk factors in women. This suggests that sex differences may be driven by the greater risk factor burden in women.",2020,Cardiovascular events occurred in 46 (22%) women and 59 (15%) men (P = 0.03).,"['patients with permanent atrial fibrillation', 'Permanent Atrial Fibrillation (RACE II) randomized 614 patients, 211 women and 403 men, to lenient or strict rate control', 'permanent AF patients']",[],"['coronary artery disease', 'Rate Control Efficacy', 'accumulation of AF risk factors', 'quality of life', 'Cardiovascular events', 'yearly cardiovascular event-rate', 'hypertension', 'cardiovascular events during 3-year follow-up (cardiovascular death, heart failure hospitalization, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events), outcome parameters, and QoL', 'risk factors', 'risk factors, outcome, and quality of life (QoL', 'heart failure with preserved ejection fraction', 'cardiovascular event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation (disorder)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}]",[],"[{'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",614.0,0.169607,Cardiovascular events occurred in 46 (22%) women and 59 (15%) men (P = 0.03).,"[{'ForeName': 'Mariëlle', 'Initials': 'M', 'LastName': 'Kloosterman', 'Affiliation': 'Department of Cardiology, Thoraxcenter, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Bart A', 'Initials': 'BA', 'LastName': 'Mulder', 'Affiliation': 'Department of Cardiology, Thoraxcenter, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Hessel F', 'Initials': 'HF', 'LastName': 'Groenveld', 'Affiliation': 'Department of Cardiology, Thoraxcenter, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'Department of Cardiology, Thoraxcenter, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'Department of Cardiology, Thoraxcenter, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Department of Cardiology, Thoraxcenter, University of Groningen, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, the Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz300']
675,31095318,Engaging Caregivers in Health-Related Housing Decisions for Older Adults With Cognitive Impairment: A Cluster Randomized Trial.,"BACKGROUND AND OBJECTIVES


Informal caregivers are rarely as involved as they want to be in the housing decisions of cognitively impaired older adults. Lack of awareness of available options and their benefits and risks may lead to decisions that do not reflect older adults' preferences, and to guilt and regret. We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
RESEARCH DESIGN AND METHODS


In a two-arm pragmatic cluster randomized trial with home care teams working in health centers in the Province of Quebec, we randomized health centers to receive training in interprofessional SDM (intervention) or not (control). Eligible caregivers had made a housing decision for a cognitively impaired adult aged 65 years or older who was receiving services from a home care team. The primary outcome was the proportion of caregivers reporting an active role in decision making. We performed intention-to-treat multilevel analysis.
RESULTS


We consecutively enrolled a random group of 16 health centers and recruited 309 caregivers, among whom 296 were included in the analysis. In the intervention arm, the proportion of caregivers reporting an active role in decision making increased by 12% (95% CI -2% to 27%; p = .10). After removal of an influential cluster outlier, the proportion increased to 18% (95% CI: 7%-29%; p < .01).
DISCUSSION AND IMPLICATIONS


Training home care teams in interprofessional SDM increased caregiver involvement in health-related housing decisions for cognitively impaired older adults.",2020,"We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
","['in health centers in the Province of Quebec', 'cognitively impaired older adults', 'consecutively enrolled a random group of 16 health centers and recruited 309 caregivers, among whom 296 were included in the analysis', 'Eligible caregivers had made a housing decision for a cognitively impaired adult aged 65 years or older who was receiving services from a home care team', 'Older Adults With Cognitive Impairment']","['home care teams working', 'training in interprofessional SDM (intervention) or not (control']",['proportion of caregivers reporting an active role in decision making'],"[{'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",,0.262906,"We assessed the effect of training home care teams in interprofessional shared decision-making (SDM) on the proportion of caregivers who report being active in this decision.
","[{'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'Ottawa Hospital Research Institute and Faculty of Health Sciences, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Brière', 'Affiliation': 'Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, Québec, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Freitas', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'Garvelink', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Maman Joyce', 'Initials': 'MJ', 'LastName': 'Dogba', 'Affiliation': 'Department of Family Medicine and Emergency Medicine.'}, {'ForeName': 'Pierre J', 'Initials': 'PJ', 'LastName': 'Durand', 'Affiliation': 'Department of Family Medicine and Emergency Medicine.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'School of Nutrition, Québec, Canada.'}, {'ForeName': 'Jordie', 'Initials': 'J', 'LastName': 'Croteau', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}, {'ForeName': 'Louis-Paul', 'Initials': 'LP', 'LastName': 'Rivest', 'Affiliation': 'Department of Mathematics and Statistics, Université Laval, Québec, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec, Canada.""}]",The Gerontologist,['10.1093/geront/gnz045']
676,31609689,Behavioral Activation for Promoting Well-Being in Mild Dementia: Feasibility and Outcomes of a Pilot Randomized Controlled Trial.,"Engaging in meaningful and enjoyable activities is an important contributor to well-being and maintaining good quality of life. There is a paucity of randomized controlled trials of interventions supporting people with mild dementia to engage in meaningful and purposeful activity. The aim of this study was to assess whether Behavioral Activation (BA) is an acceptable psychological intervention for people with mild dementia and whether a large-scale trial is feasible. Participants were randomly assigned to BA (n = 42) or treatment as usual (TAU) (n = 21). BA aimed at increasing engagement in enjoyable and meaningful activity, and preventing low mood. Follow-up was at 3 and 6 months. Assessors were blind to treatment allocation (trial registration number: ISRCTN75503960). Retention rate was above 80% at both assessment time points. Treatment acceptability and credibility were high. Depressive symptoms remained unchanged in both groups. There was evidence of improvement associated with BA for every day function (-3.92, 95% Confidence Interval (CI) -6.87 to -0.97), and engagement in meaningful and enjoyable activity (5.08, 95% CI 0.99 to 9.16) post-treatment (3 months) in comparison to TAU. Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months. Improvements in meaningful and enjoyable activity were maintained at 6 months.BA for people with mild dementia is feasible and acceptable and may be associated with clinically significant changes in function and quality of life. A full scale randomized controlled trial of clinical effectiveness is now needed.",2019,"Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months.","['Mild Dementia', 'people with mild dementia']","['Behavioral Activation (BA', 'Behavioral Activation', 'BA']","['physical health', 'meaningful and enjoyable activity', 'Depressive symptoms', 'quality of life', 'Confidence Interval (CI', 'Retention rate', 'function and quality of life']","[{'cui': 'C3494623', 'cui_str': 'Mild dementia'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.300321,"Both carer-rated patient health-related quality of life (0.16, 95% CI 0.04 to 0.28) and physical health (11.31, 95% CI 2.03 to 20.59) showed evidence of improvement at 3 months.","[{'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Orgeta', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Tuijt', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Phuong', 'Initials': 'P', 'LastName': 'Leung', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Elisabet Sole', 'Initials': 'ES', 'LastName': 'Verdaguer', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Gould', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'University College London, London, UK.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190696']
677,31609693,Low-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex Enhances Recognition Memory in Alzheimer's Disease.,"BACKGROUND


The lack of effective pharmacological or behavioral interventions for memory impairments associated with Alzheimer's disease (AD) emphasizes the need for the investigation of approaches based on neuromodulation.
OBJECTIVE


This study examined the effects of inhibitory repetitive transcranial magnetic stimulation (rTMS) of prefrontal cortex on recognition memory in AD patients.
METHODS


In a first experiment, 24 mild AD patients received sham and real 1Hz rTMS over the left and right dorsolateral prefrontal cortex (DLPFC), in different sessions, between encoding and retrieval phases of a non-verbal recognition memory task. In a second experiment, another group of 14 AD patients underwent sham controlled repeated sessions of 1Hz rTMS of the right DLPFC across a two week treatment. Non-verbal recognition memory task was performed at baseline, at the end of the two weeks period and at a follow up of 1 month.
RESULTS


Right real rTMS significantly improved memory performance compared to right sham rTMS (p = 0.001). Left real rTMS left the memory performance unchanged as compared with left sham rTMS (p = 0.46). The two sham conditions did not differ between each other (p = 0.24). In the second experiment, AD patients treated with real rTMS showed an improvement of memory performance at the end of the two weeks treatment (p = 0.0009), that persisted at 1-month follow-up (p = 0.002).
CONCLUSION


These findings provide evidence that inhibitory rTMS over the right DLPFC can improve recognition memory function in AD patients. They also suggest the importance of a new approach of non-invasive brain stimulation as a promising treatment in AD.",2019,Left real rTMS left the memory performance unchanged as compared with left sham rTMS (p = 0.46).,"[""Alzheimer's Disease"", '24 mild AD patients received', ""memory impairments associated with Alzheimer's disease (AD"", 'AD patients']","['real rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation', 'sham and real 1Hz rTMS', 'inhibitory repetitive transcranial magnetic stimulation (rTMS', 'behavioral interventions']","['memory performance', 'recognition memory function']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0479729,Left real rTMS left the memory performance unchanged as compared with left sham rTMS (p = 0.46).,"[{'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Turriziani', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Smirni', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Giuseppa Renata', 'Initials': 'GR', 'LastName': 'Mangano', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Zappalà', 'Affiliation': 'Unità di Neurologia Cognitiva e Riabilitazione, ARNAS Garibaldi, Catania, Italy.'}, {'ForeName': 'Andreina', 'Initials': 'A', 'LastName': 'Giustiniani', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cipolotti', 'Affiliation': 'Department of Neuropsychology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Oliveri', 'Affiliation': 'Department of Psychology, Educational Sciences and Human Movement, University of Palermo, Palermo, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190888']
678,31743533,"Perioperative intravenous low-dose ketamine for neuropathic pain after major lower back surgery: A randomized, placebo-controlled study.","BACKGROUND


Chronic pain after major lower back surgery is frequent. We investigated in adults the effect of perioperative low-dose ketamine on neuropathic lower back pain, assessed by the DN4 questionnaire, 6 and 12 months after major lower back surgery.
METHODS


In this single-centre randomized trial, 80 patients received intravenous ketamine 0.25 mg/kg preoperatively, followed by 0.25 mg kg -1   hr -1  intraoperatively, and 0.1 mg kg -1   hr -1  from 1 hr before the end of surgery until the end of recovery room stay; 80 controls received placebo.
RESULTS


Preoperatively, 47.4% of patients in the ketamine group and 46.3% in the placebo group had neuropathic pain; 10% and 3.8%, respectively, were using strong opioids. At the end of the infusion, the median cumulative dose of ketamine was 84.8 mg (IQR 67.4-106.7) and the median plasma level was 97 ng/ml (IQR 77.9-128.0). At 6 months, 28.8% of patients in the ketamine group and 23.5% in the placebo group had neuropathic pain (absolute difference, 5.2%; 95% CI -10.7 to 21.1; p = .607). At 12 months, 26.4% of patients in the ketamine group and 17.9% in the placebo group had neuropathic pain (absolute difference 8.5%; 95% CI -6.7 to 23.6; p = .319).
CONCLUSIONS


In this patient population with a high prevalence of neuropathic lower back pain undergoing major lower back surgery, a perioperative intravenous low-dose ketamine infusion did not have an effect on the prevalence of neuropathic lower back pain at 6 or 12 months postoperatively.
SIGNIFICANCE


We were unable to show any analgesic benefit of a short-term perioperative ketamine infusion as an adjuvant to multimodal analgesia in patients with a high prevalence of neuropathic lower back pain undergoing major back surgery. Based on these data, the widespread opinion that ketamine is universally analgesic across different pain conditions must be challenged.
PRIOR PRESENTATIONS


Abstract presentation at the annual congress of the Swiss Society of Anaesthesiology, 2016, Basel, Switzerland.
CLINICAL TRIAL NUMBER AND REGISTRY URL


Registered by Dr Christoph Czarnetzki as principal investigator on February 20, 2008 at clinicaltrials.gov (NCT00618423).",2020,"At six months, 28.8% of patients in the ketamine group and 23.5% in the placebo group had neuropathic pain (absolute difference, 5.2%; 95% CI -10.7 to 21.1; p = .607).","['patient population with a high prevalence of neuropathic lower back pain undergoing major lower back surgery', '80 patients received', 'neuropathic pain after major lower back surgery']","['intravenous ketamine 0.25\xa0mg/kg preoperatively, followed by 0.25\xa0mg/kg\xa0hr -1  intraoperatively, and 0.1\xa0mg/kg', 'perioperative low-dose ketamine', 'ketamine', 'placebo', 'Perioperative intravenous low-dose ketamine']","['median cumulative dose of ketamine', 'neuropathic pain', 'neuropathic lower back pain', 'median plasma level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0741419', 'cui_str': 'Back surgery'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",80.0,0.632658,"At six months, 28.8% of patients in the ketamine group and 23.5% in the placebo group had neuropathic pain (absolute difference, 5.2%; 95% CI -10.7 to 21.1; p = .607).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Czarnetzki', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Desmeules', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tessitore', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Faundez', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, Department of Surgery, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Chabert', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Daali', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Roxane', 'Initials': 'R', 'LastName': 'Fournier', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dupuis-Lozeron', 'Affiliation': 'Clinical Research Centre & Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cedraschi', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Richard Tramèr', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.'}]","European journal of pain (London, England)",['10.1002/ejp.1507']
679,30145738,Factors associated with physical activity of breast cancer patients participating in exercise intervention.,"PURPOSE


Physical activity has been known to improve survival and quality of life of patients with breast cancer. To find factors associated with physical activity, we analyzed the dataset of the multicenter controlled trial of exercise intervention.
METHODS


Three hundred fifty-six participants were assigned to two groups: ""Smart After-Care"" (smartphone application and pedometer were provided) or exercise education only. Physical activity was measured by International Physical Activity Questionnaire-Short Form (IPAQ-SF) at baseline and after 12 weeks. The association between physical activity and other clinical characteristics was analyzed.
RESULTS


At baseline, physical activity amount was 2315.5 ± 3513.2 MET min/week: 33.0% inactive, 49.6% minimally active, and 17.4% health-enhancing physical activity (HEPA) active. Factors associated with HEPA include cancer stage and grip strength. A significantly lower proportion was HEPA active among those with advanced stage than among those with stage 0. After intervention, physical activity was increased to 3466.2 ± 4712.5 MET min/week: 15.3% inactive, 50.4% minimally active, and 34.2% HEPA active. Physical activity was increased in 63.4% of the participants. Factors associated with physical activity increase include cancer stage, diarrhea, and type of exercise intervention. Participants with advanced stage have a 3.3 times higher chance of increasing physical activity. Participants who received ""Smart After-Care"" have a 64% higher chance of increasing physical activity.
CONCLUSION


Before the intervention, participants with advanced stage are less likely to be HEPA active. Exercise intervention was more beneficial for those with advanced stage or physical symptoms. ""Smart After-Care"" was more effective than education only in increasing physical activity.",2019,"After intervention, physical activity was increased to 3466.2 ± 4712.5 MET min/week: 15.3% inactive, 50.4% minimally active, and 34.2% HEPA active.","['breast cancer patients participating in', 'participants with advanced stage are less likely to be HEPA active', 'Three hundred fifty-six participants', 'patients with breast cancer', 'Participants with advanced stage']","['exercise intervention', 'Exercise intervention', 'Smart After-Care"" (smartphone application and pedometer were provided) or exercise education only']","['International Physical Activity Questionnaire-Short Form (IPAQ-SF', 'survival and quality of life', 'HEPA include cancer stage and grip strength', 'cancer stage, diarrhea, and type of exercise intervention', 'Physical activity', 'physical activity']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0582396', 'cui_str': 'Exercise health education'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]",356.0,0.0429341,"After intervention, physical activity was increased to 3466.2 ± 4712.5 MET min/week: 15.3% inactive, 50.4% minimally active, and 34.2% HEPA active.","[{'ForeName': 'Si-Woon', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': ""Department of Rehabilitation Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Ilkyun', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea. iklee68@gmail.com.""}, {'ForeName': 'Joong Il', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Hyuna', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': ""Cancer Healing Education Center, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Jong Doo', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': ""Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.""}, {'ForeName': 'Kyeong Eun', 'Initials': 'KE', 'LastName': 'Uhm', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'So-Youn', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Center for Breast Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, South Korea.""}, {'ForeName': 'Ji Youl', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, South Korea.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4427-3']
680,32118081,"Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 1 Year: A Prospective, Randomized Trial.","Background


Approximately 47 million people in the United States have been diagnosed with arthritis. Autologous platelet-rich plasma (PRP) injections have been documented to alleviate symptoms related to knee osteoarthritis (OA) in randomized controlled trials, systematic reviews, and meta-analyses. Autologous bone marrow aspirate concentrate (BMC) injections have also emerged as a treatment option for knee OA, with a limited clinical evidence base.
Purpose


To compare the efficacy of BMC to PRP for the treatment of knee OA regarding pain and function at multiple time points up to 12 months after an injection. We hypothesized that BMC will be more effective in improving outcomes in patients with knee OA.
Study Design


Randomized controlled trial; Level of evidence, 2.
Methods


A total of 90 participants aged between 18 and 80 years with symptomatic knee OA (Kellgren-Lawrence grades 1-3) were randomized into 2 study groups: PRP and BMC. Both groups completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and subjective International Knee Documentation Committee (IKDC) questionnaires before and 1, 3, 6, 9, and 12 months after a single intra-articular injection of leukocyte-rich PRP or BMC.
Results


There were no statistically significant differences in baseline IKDC or WOMAC scores between the 2 groups. All IKDC and WOMAC scores for both the PRP and BMC groups significantly improved from baseline to 1 month after the injection ( P  < .001). These improvements were sustained for 12 months after the injection, with no difference between PRP and BMC at any time point.
Conclusion


Both PRP and BMC were effective in improving patient-reported outcomes in patients with mild to moderate knee OA for at least 12 months; neither treatment provided a superior clinical benefit. Autologous PRP and BMC showed promising clinical potential as therapeutic agents for the treatment of OA, and while PRP has strong clinical evidence to support its efficacy, BMC has limited support. This study did not prove BMC to be superior to PRP, providing guidance to clinicians treating OA. It is possible that the results were affected by patients knowing that there was no control group.
Registration


NCT03289416 (ClinicalTrials.gov identifier).",2020,All IKDC and WOMAC scores for both the PRP and BMC groups significantly improved from baseline to 1 month after the injection ( P  < .001).,"['Knee Osteoarthritis at 1 Year', '90 participants aged between 18 and 80 years with symptomatic knee OA (Kellgren-Lawrence grades 1-3', 'patients with knee OA']","['Autologous platelet-rich plasma (PRP) injections', 'PRP and BMC', 'Autologous bone marrow aspirate concentrate (BMC) injections', 'Autologous PRP and BMC', 'BMC']","['PRP and BMC', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and subjective International Knee Documentation Committee (IKDC) questionnaires', 'baseline IKDC or WOMAC scores', 'All IKDC and WOMAC scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0857285', 'cui_str': 'Marrow aspirate'}]","[{'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",90.0,0.0886818,All IKDC and WOMAC scores for both the PRP and BMC groups significantly improved from baseline to 1 month after the injection ( P  < .001).,"[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Anz', 'Affiliation': 'Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Hubbard', 'Affiliation': 'Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Rendos', 'Affiliation': 'Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Everts', 'Affiliation': 'Gulf Coast Biologics, Fort Myers, Florida, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.'}, {'ForeName': 'Joshua G', 'Initials': 'JG', 'LastName': 'Hackel', 'Affiliation': 'Andrews Research & Education Foundation, Gulf Breeze, Florida, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967119900958']
681,31738468,Effects of fitness level and exercise intensity on pain and mood responses.,"BACKGROUND


The phenomenon of exercise-induced hypoalgesia and concomitant mood changes is well-established. How exercise-induced hypoalgesia and affective responses are shaped by the intensity of an acute exercise bout and individual fitness levels is as yet not well-understood. This study investigates whether heat pain threshold (PTh), pain tolerance (PTol) and affective parameters are modulated by the intensity of an acute exercise bout and/or individuals' fitness level. Stronger analgesic responses are hypothesized after high-intensity exercise in physically fitter subjects, possibly in sync with concomitant mood changes.
METHODS


Thirty-three healthy men were recruited (sedentary: N = 17 or recreational: N = 14; mean age: 25.3 ± 4.4 years). After a fitness assessment on a cycle ergometer, subjects underwent three experimental conditions on separate days: high (20 min exercise 20% above lactate threshold), low (20 min exercise 20% below lactate threshold) and control (seated rest). Before and after each intervention Positive and Negative Affect Schedule, PTh and PTol (cold water emersion test) were assessed.
RESULTS


Results indicate an increase of the Positive Affect Scale (high: 26.7 ± 9.0 vs. 32.9 ± 7.1, p < .001; low: 26.3 ± 7.2 vs. 32.0 ± 7.0, p < .001) and PTh (high: 45.1 ± 3.1°C vs. 46.0 ± 2.6°C, p = .003; low: 45.4 ± 2.7°C vs. 45.9 ± 2.6°C, p = .012) after both exercise conditions. In an exploratory analysis, PTol significantly increased only after the high exercise condition (51.2 ± 33.7 s vs. 72.4 ± 64.0 s, p = .045). Fitness level was positively correlated with the increase in PTol from pre to post high-intensity exercise (r = .59, p (one-tailed) = .002).
CONCLUSION


Exercise-induced hypoalgesia depends on exercise intensity and appears to be influenced by individual fitness status, independent of mood responses.
SIGNIFICANCE


Antinociceptive effects can be elicited by physical exercise and have been extensively investigated in the literature. However, the relation between exercise intensity, fitness status, and the degree of antinociception is not well-understood. This randomized intervention provides novel evidence that antinociceptive effects indeed depend on exercise intensity, but also on general fitness status. Data extend the existing literature by highlighting aspects of exercise behaviour that promote antinociception. Effects do not simply mirror positive affective responses induced by exercise, hence, indicating partially distinct underlying mechanisms.",2020,"low: 26.3±7.2 vs. 32.0±7.0, p<0.001) and PTh",['Thirty-three healthy men were recruited (sedentary: N=17 or recreational: N=14; mean age: 25.3±4.4 years'],"['exercise 20% above lactate threshold), low (20 minutes exercise 20% below lactate threshold) and control (seated rest', 'Exercise-induced hypoalgesia', 'Fitness Level and Exercise Intensity', 'PTh']","['heat pain threshold (PTh), pain tolerance (PTol), and affective parameters', 'Fitness level', 'Pain and Mood Responses', 'Positive Affect Scale (high']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0085625', 'cui_str': 'Hypoalgesia (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",33.0,0.0465633,"low: 26.3±7.2 vs. 32.0±7.0, p<0.001) and PTh","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Schmitt', 'Affiliation': 'Functional Neuroimaging Group, Department of Radiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Wallat', 'Affiliation': 'Functional Neuroimaging Group, Department of Radiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Stangier', 'Affiliation': 'DZNE, German Center for Neurodegenerative Diseases, Bonn, Germany.'}, {'ForeName': 'Jason Anthony', 'Initials': 'JA', 'LastName': 'Martin', 'Affiliation': 'Functional Neuroimaging Group, Department of Radiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schlesinger-Irsch', 'Affiliation': 'Department of Radiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Boecker', 'Affiliation': 'Functional Neuroimaging Group, Department of Radiology, University Hospital Bonn, Bonn, Germany.'}]","European journal of pain (London, England)",['10.1002/ejp.1508']
682,31481605,Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial.,"INTRODUCTION


AsthmaTuner is a novel self-management system consisting of a patient app, a cloud-based storage solution and a healthcare interface. Patients use Bluetooth spirometers to measure lung function (forced expiratory volume in 1 s) and can register symptoms. They then receive immediate feedback on asthma control and an image of the correct inhaler(s) to use and the dose. The aim of this pilot study was to evaluate the effect of AsthmaTuner on symptom control and adherence compared with conventional treatment.
MATERIAL AND METHODS


This multicentre physician-blinded crossover trial randomised patients in two groups that started with 8 weeks of AsthmaTuner or conventional treatment using a personalised printed treatment plan, with 2 weeks of washout between the crossover treatments. Participants in a primary or paediatric care setting in Sweden with asthma diagnosis, uncontrolled symptoms and Asthma Control Test (ACT) score <20 points were included. Symptom control was analysed using t-tests for the difference between the group means of the sums of ACT scores at each treatment end-visit, with 95% confidence intervals. Medical Adherence Report Scale (MARS) scores captured differences in adherence (remembering to take asthma medication) between treatment periods.
RESULTS


The study population consisted of 77 patients (60% females). The ACT score significantly improved with AsthmaTuner compared with conventional treatment (mean ACT difference 0.70, 95% CI 0.06-1.34; p=0.03). Adherence did not improve significantly in all participants, but did improve among those in primary care who used AsthmaTuner an average of once a week or more compared with conventional treatment (mean MARS difference 0.45, 95% CI 0.13-0.77; p=0.01).
CONCLUSIONS


AsthmaTuner improved symptom control in patients with uncontrolled asthma compared with conventional treatment.",2019,"The ACT significantly improved with AsthmaTuner compared with conventional treatment (mean 0.70 [0.06-1.34], p=0.03).","['patients with uncontrolled asthma', '77 patients (60% females', 'Participants in a primary or paediatric care setting in Sweden with asthma diagnosis, uncontrolled symptoms and Asthma Control Test (ACT)<20 points were included']","['AsthmaTuner or conventional treatment', 'AsthmaTuner', 'novel digital automated self-management solution']","['symptom control and adherence', 'Adherence', 'Medical Adherence Report Scale scores', 'Symptom control', 'symptom control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care (regime/therapy)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",77.0,0.0898205,"The ACT significantly improved with AsthmaTuner compared with conventional treatment (mean 0.70 [0.06-1.34], p=0.03).","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ljungberg', 'Affiliation': ""Lung-Allergy Dept, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carleborg', 'Affiliation': ""Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Hilmar', 'Initials': 'H', 'LastName': 'Gerber', 'Affiliation': 'Sophiahemmet Health Care Centre, Stockholm, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Öfverström', 'Affiliation': 'Sophiahemmet Health Care Centre, Stockholm, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Wolodarski', 'Affiliation': 'Sophiahemmet Health Care Centre, Stockholm, Sweden.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Menshi', 'Affiliation': ""Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Engdahl', 'Affiliation': ""Dept of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Eduards', 'Affiliation': 'Liljeholmen Health Care Centre, Stockholm Health Care Services (SLSO), Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Nordlund', 'Affiliation': ""Lung-Allergy Dept, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden bjorn.nordlund@ki.se.""}]",The European respiratory journal,['10.1183/13993003.00983-2019']
683,31735969,Weight Loss Intervention Impact on the Physical Fitness Test Scores of Air Force Service Members.,"INTRODUCTION


Overweight and obesity are a major public health concern in the United States, including among active duty military personnel. Approximately 51% of active duty personnel are classified as overweight and 15% are classified as obese. This may impact military readiness. The current study aimed to determine if a weight loss intervention impacted fitness test scores among Air Force personnel.
MATERIALS AND METHODS


From 2014 to 2016, 204 Air Force members with overweight/obesity were randomized into either a Self-paced or counselor-initiated arm in a weight loss program. Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center. Fitness test scores from before, during, and after the intervention were used to determine if the intervention resulted in improvements in overall fitness test ratings and scores on individual components of the test.
RESULTS


Participants who lost at least 5% of their weight had better fitness ratings during the intervention compared to individuals who did not lose 5%. However, in the overall sample, fitness ratings worsened from preintervention to during the intervention, and from during to postintervention. Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity.
CONCLUSIONS


Behavioral weight management interventions that achieve 5% weight loss may help improve military fitness test ratings.",2020,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity.
","['Participants with overweight', 'From 2014 to 2016, 204 Air Force members with overweight/obesity', 'Study procedures were approved by the Institutional Review Board of the 59th Medical Wing in San Antonio and were acknowledged by the Institutional Review Board at the University of Tennessee Health Science Center']","['weight loss intervention', 'Self-paced or counselor-initiated arm in a weight loss program']","['abdominal circumference scores and better fitness test ratings preintervention', 'fitness ratings', 'overall fitness test ratings and scores on individual components of the test', 'military fitness test ratings']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039514', 'cui_str': 'Tennessee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]",204.0,0.022092,"Participants with overweight had better aerobic scores pre- and postintervention as well as better abdominal circumference scores and better fitness test ratings preintervention, during the intervention and postintervention compared to participants with obesity.
","[{'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Pebley', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Beauvais', 'Affiliation': 'Brooke Army Medical Center, Joint Base San Antonio-Lackland Air Force Base, San Antonio, TX.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Gladney', 'Affiliation': 'Department of Neurology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Robert C Klesges', 'Initials': 'RCK', 'LastName': 'Klesges', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Hare', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Phyllis A', 'Initials': 'PA', 'LastName': 'Richey', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hryshko-Mullen', 'Affiliation': 'Department of Mental Health, Wilford Hall Ambulatory Surgical Center, Joint Base San Antonio-Lackland AFB, San Antonio, TX.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Public Health Sciences, Center for Addiction Prevention Research, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN.'}]",Military medicine,['10.1093/milmed/usz371']
684,31727667,Evaluation of the Choosing Wisely Australia 5 Questions resource and a shared decision-making preparation video: protocol for an online experiment.,"INTRODUCTION


Choosing Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change. In Australia, Choosing Wisely has developed a 5 Questions resource to facilitate better conversations. The primary aim of this study is to evaluate the impact of the Choosing Wisely Australia 5 Questions resource and a video designed to prepare patients for question-asking and participation in shared decision-making on (a) self-efficacy to ask questions and participate in shared decision-making, (b) intention to participate in shared decision-making and (c) a range of secondary outcomes. The secondary aim of this study is to determine whether participants' health literacy modifies the effects of the interventions.
METHODS AND ANALYSIS


We will use 2×2×2 between-subjects factorial design (preparation video: yes, no × Choosing Wisely 5 Questions resource: yes, no × health literacy: adequate, inadequate). Participants will be recruited by an online market research company, presented with a hypothetical non-specific low back pain scenario, and randomised to study groups stratified by health literacy. Quantitative primary and secondary outcome data will be analysed as intention-to-treat using appropriate regression models (ie, linear regression for continuous outcomes, logistic regression for dichotomous categorical outcomes).
ETHICS AND DISSEMINATION


Ethical approval for this study was obtained from the University of Sydney Human Research Ethics Committee (protocol number: 2018/965). The results from this work will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies. Resources developed for this study will be made available to patients and clinicians following trial completion.
TRIAL REGISTRATION NUMBER


This trial has been registered with the Australia New Zealand Clinical Trials Registry (trial number: 376477) and the stage is Pre-results.",2019,"Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change.","['Participants will be recruited by an online market research company, presented with a hypothetical non-specific low back pain scenario', ""participants' health literacy""]",[],[],"[{'cui': 'C0024825', 'cui_str': 'Market Research'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",[],[],,0.22808,"Wisely, an international effort to reduce low value care worldwide, considers communication between clinicians and patients during routine clinical encounters a key mechanism for change.","[{'ForeName': 'Danielle Marie', 'Initials': 'DM', 'LastName': 'Muscat', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia danielle.muscat@sydney.edu.au.'}, {'ForeName': 'Edward Hoi-Fan', 'Initials': 'EH', 'LastName': 'Chang', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Zadro', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jessica Kathleen', 'Initials': 'JK', 'LastName': 'Smith', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Lindner', 'Affiliation': 'NPS Medicinewise, Strawberry Hills, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033126']
685,31069459,Effect of probiotic yoghurt on plasma glucose in overweight and obese pregnant women: a randomized controlled clinical trial.,"INTRODUCTION


There is only some evidence about effectiveness of probiotics for preventing gestational hyperglycaemia. This trial examined the effects of probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 on maternal plasma glucose (primary outcome) and on some maternal and infant complications (secondary outcomes) in overweight and obese women with no diabetes in pregnancy.
METHODS


Using stratified block randomization, women with pre- or early-pregnancy BMI ≥ 25 and fasting plasma glucose < 92 mg/dl at 22 weeks of gestation were assigned into probiotic or conventional yoghurt group, consuming 100 g/day from 24 weeks of gestation until delivery. The women and their infants were followed up until 1 month after birth.
RESULTS


In each group, one out of 65 women had intra-uterine foetal death and were not analysed for other outcomes. The mean BMI was 29.2 (SD 3.3) in probiotic and 30.3 (SD 4.1) in conventional yoghurt group. Four weeks after initiation of the treatment, plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting (mean difference adjusted for the BMI category) and baseline FPG (- 4.0 mg/dl; 95% confidence interval - 6.9, - 1.1) and 2-h OGTT (- 13.9; - 22.8, - 5.0). At the 1-h OGTT, however, the difference was not statistically significant (- 9.8; - 20.6, 0.9). Further, there was a significantly lower infant bilirubin level in the probiotic group on days 3-5 after birth (- 2.2 mg/dl; - 3.3, - 1.2). There were not statistically significant differences between the groups regarding the risk of gestational diabetes (6 vs 11; odds ratio 0.5; 0.2, 1.5), preterm delivery (3 vs 8; 0.3; 0.1, 1.2), and other maternal and infant outcomes.
CONCLUSION


The probiotics supplementation has some beneficial effects on glucose metabolism of overweight and obese pregnant women. Nevertheless, further studies are required to judge the clinical significance of such effects.",2020,"Four weeks after initiation of the treatment, plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting (mean difference adjusted for the BMI category) and baseline FPG (- 4.0 mg/dl;","['overweight and obese pregnant women', 'women with pre- or early-pregnancy BMI\u2009≥', 'overweight and obese women with no diabetes in pregnancy']","['probiotics supplementation', 'probiotic yoghurts containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12', 'probiotic yoghurt']","['preterm delivery', 'plasma glucose', 'gestational hyperglycaemia', 'intra-uterine foetal death', 'risk of gestational diabetes', 'mean BMI', 'plasma glucose levels', 'maternal plasma glucose', 'infant bilirubin level']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}]",65.0,0.098611,"Four weeks after initiation of the treatment, plasma glucose levels were significantly lower in the probiotic than in conventional yoghurt group at fasting (mean difference adjusted for the BMI category) and baseline FPG (- 4.0 mg/dl;","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Asgharian', 'Affiliation': ""Students' Research Committee, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, IR, Iran.""}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Homayouni-Rad', 'Affiliation': 'Department of Food Science and Technology, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, IR, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Center, Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, IR, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Research Center for Evidence-Based Medicine, Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Shariatie Ave., P.O. Box: 51745-347, Tabriz, IR, 513897977, Iran. alizades@tbzmed.ac.ir.'}]",European journal of nutrition,['10.1007/s00394-019-01900-1']
686,31057060,Evaluation of Pharmacist Medication Review Service in an Outpatient Heart Failure Clinic.,"PURPOSE


The purpose of this study was to evaluate the impact of pharmacist medication reviews on drug-related problems (DRPs) in a population with ambulatory heart failure (HF).
METHODS


The HF pharmacist medication review service incorporated a comprehensive medication review note provided to the cardiologist in a HF clinic. A retrospective chart review was performed on 64 control patients with no previous pharmacist review and 64 intervention patients who had a pharmacist medication review. The primary end point was the number of DRPs identified per patient in the intervention group 2 weeks after pharmacist medication review compared to the number of DRPs identified per patient in the control group.
RESULTS


The average DRPs per patient was reduced from 2.80 to 1.95 in intervention group after pharmacist intervention. There was a statistically significant difference between the average DRPs per patient in the control and intervention groups, 2.55 DRPs versus 1.95 DRPs per patient, respectively ( P  = .016). Medication adherence (78%), renal dosing (67%), hypertension (58%), and HF DRPs (55%) had the highest acceptance rate. The majority of DRP recommendations in the intervention (87%) and control groups (87%) were high-impact recommendations.
CONCLUSIONS


Pharmacist medication reviews in an ambulatory HF clinic lead to significantly fewer DRPs.",2020,The average DRPs per patient was reduced from 2.80 to 1.95 in intervention group after pharmacist intervention.,"['64 control patients with no previous pharmacist review and 64 intervention patients who had a pharmacist medication review', 'Outpatient Heart Failure Clinic', 'population with ambulatory heart failure (HF']",[],"['Medication adherence', 'average DRPs per patient', 'average DRPs', 'hypertension', 'HF DRPs', 'number of DRPs', 'highest acceptance rate']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]",[],"[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",64.0,0.0272173,The average DRPs per patient was reduced from 2.80 to 1.95 in intervention group after pharmacist intervention.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Yates', 'Affiliation': 'Department of Pharmacy, 20082Cincinnati Veterans Affairs Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Valente', 'Affiliation': 'Department of Pharmacy, 2559MetroHealth Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wadsworth', 'Affiliation': 'Department of Pharmacy, 2559MetroHealth Medical Center, Cleveland, OH, USA.'}]",Journal of pharmacy practice,['10.1177/0897190019842696']
687,31728673,Lower prednisone dosing for steroid-sensitive nephrotic syndrome relapse: a prospective randomized pilot study.,"Relapses of steroid-sensitive nephrotic syndrome are traditionally treated with prednisone 2 mg/kg/day or 60 mg/m 2 /day. Retrospective data support the use of lower doses. We designed a prospective randomized pilot study to investigate the efficacy of different doses in achieving remission of steroid sensitive nephrotic syndrome relapse. The cohort included 30 children with relapsed steroid sensitive nephrotic syndrome, mean age 6.3 ± 3 years and mean disease duration 2.2 ± 1.8 years. The children were randomized to receive 2, 1.5, or 1 mg/kg/day prednisone. The corresponding times to response, defined as the first of 3 consecutive days without proteinuria, were 7.2 ± 1.4, 10.2 ± 5.1, and 9 ± 3.3 days; the difference between the 1.5 and 2 mg/kg/day groups was statistically significant. One patient each in the 1 mg/kg/day and the 1.5 mg/kg/day groups failed to respond and were switched to 2 mg/kg/day, leading to a response after 3 and 10 days, respectively. Mean cumulative prednisone doses in the 3 groups were 45.5 ± 3.4, 42.7 ± 25.9, and 24.9 ± 7.4 mg/kg, respectively (P < 0.05).Conclusion: In the present study, treatment of childhood steroid sensitive nephrotic syndrome relapse with prednisone 1-1.5 mg/kg/day led to a significantly lower cumulative dose than the standard dose. Treatment with a lower dose may be equally safe and effective to the standard dose.What is Known:• Relapses of steroid-sensitive nephrotic syndrome are traditionally treated with standard-dose steroids.• Treatment with corticosteroids may have significant adverse effects mainly with long-term use.What is New:• Treatment of steroid sensitive nephrotic syndrome relapse with 1-1.5 mg/kg/day prednisone may lead to a significantly lower cumulative dose.• Treatment with a lower steroid dose may be as effective as the standard dose in achieving remission of steroid sensitive nephrotic syndrome relapse.",2020,We designed a prospective randomized pilot study to investigate the efficacy of different doses in achieving remission of steroid sensitive nephrotic syndrome relapse.,"['30 children with relapsed steroid sensitive nephrotic syndrome, mean age 6.3\u2009±\u20093\xa0years and mean disease duration 2.2\u2009±\u20091.8\xa0years', 'sensitive nephrotic syndrome relapse']","['steroid', 'prednisone']",['Mean cumulative prednisone doses'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403396', 'cui_str': 'Steroid-sensitive nephrotic syndrome (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",30.0,0.020056,We designed a prospective randomized pilot study to investigate the efficacy of different doses in achieving remission of steroid sensitive nephrotic syndrome relapse.,"[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Borovitz', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Alfandary', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Haskin', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Shely', 'Initials': 'S', 'LastName': 'Levi', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Shulamit', 'Initials': 'S', 'LastName': 'Kaz', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Davidovits', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dagan', 'Affiliation': ""Institute of Nephrology, Schneider Children's Medical Center of Israel, 4920235, Petach Tikva, Israel. dagana@clalit.org.il.""}]",European journal of pediatrics,['10.1007/s00431-019-03506-5']
688,31728675,Repeating a dose of sucrose for heel prick procedure in preterms is not effective in reducing pain: a randomised controlled trial.,"Oral sucrose is included in almost all recommendations for treatment of pain in newborns, but evidence if multiple doses might be more effective than a single standard dose is lacking. We designed a single-centre, double-blind, randomised, controlled trial. We enrolled preterm infants needing the heel prick procedure. Each enrolled infant was randomised to receive a single standard dose of sucrose 2 min before or a double dose of sucrose 2 min before, and 30 s after heel prick. Primary outcome was the efficacy of the two interventions tested by the premature infant pain profile-PIPP scale obtained at 30 s, 60 s, and 120 s after heel prick. Secondary outcome was the evaluation of the concordance between the PIPP scale and other pain scores more feasible in clinical practice. Seventy-two infants were randomised. No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline; 6.0(IQR 5.0-10.0) vs 6.0(IQR 4.0-8.5) at 30 s; 6.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-8.5) at 60 s and 5.0(IQR 4.0-7.0) vs 5.0(IQR 4.0-7.5) at 2 min, in the experimental and standard treatment groups, respectively (p = 0.9020). There was no correlation between PIPP scores and other pain scales.Conclusion: We do not recommend doubling the dose during heel prick.What is Known:• Oral sucrose is included in almost all international position papers and recommendations for the treatment of mild to moderate pain in newborns, associated with non-nutritive sucking and facilitated tucking• Premature infant pain profile (PIPP) scale is the gold standard for evaluation of pain in preterms but it is difficult to use in clinical practiceWhat is New:• Repeating a dose of 24% sucrose is not effective in reducing pain during the recovery phase of a skin breaking procedure• Other pain scales, easier to use in clinical practice, are not comparable with PIPP for the evaluation of procedural pain in preterms.",2020,No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline;,"['enrolled preterm infants needing the heel prick procedure', 'Seventy-two infants were randomised']","['Oral sucrose', 'sucrose']","['PIPP scores and other pain scales', 'evaluation of the concordance between the PIPP scale and other pain scores more feasible in clinical practice', 'pain', 'pain perception', 'PIPP scale', 'premature infant pain profile-PIPP scale']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]",72.0,0.483889,No difference in pain perception as measured by the PIPP scale was found between the groups: median PIPP values 4.0(IQR 3.0-4.0) vs 3.0(IQR 3.0-4.0) at baseline;,"[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Lago', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy.'}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Cavicchiolo', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy. mecavicchiolo@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Mion', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Dal Cengio', 'Affiliation': 'Neonatal Intensive Care Unit, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Allegro', 'Affiliation': 'Neonatal Intensive Care Unit, Department of Woman and Child Health, University of Padua, Via Giustiniani 3, 35128, Padua, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Daverio', 'Affiliation': 'Paediatric Intensive Care Unit, Department of Woman and Child Health, University of Padua, Padua, Italy.'}, {'ForeName': 'Anna Chiara', 'Initials': 'AC', 'LastName': 'Frigo', 'Affiliation': 'Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padua, Italy.'}]",European journal of pediatrics,['10.1007/s00431-019-03509-2']
689,31041716,Cost-effectiveness of trifluridine/tipiracil (TAS102) for heavily pretreated metastatic gastric cancer.,"BACKGROUND AND AIM


Trifluridine/tipiracil (TAS102), a novel oral cytotoxic chemotherapy, significantly improved overall survival compared with placebo in heavily pretreated advanced gastric cancer. This study aimed to evaluate the cost-effectiveness of TAS102 in the third-line or later treatment for this population from the US payer perspective.
METHODS


A Markov model was developed to simulate advanced gastric cancer, including three health states: progression-free survival (PFS), progressive disease (PD) and death. Model inputs were derived from a randomised, double-blind, placebo-controlled, phase 3 trial (TAGS trial, NCT02500043). Utilities were extracted from public resources. Costs were calculated from an American payer perspective. Sensitivity analyses were conducted to explore the impact of uncertainty.
RESULTS


From the US payer perspective, treatment with TAS102 for patients with heavily pretreated advanced gastric cancer was estimated to increase costs by $59,180 compared with the placebo, with a gain of 0.06 quality-adjusted life years (QALYs) for an incremental cost-effectiveness ratio (ICER) of $986,333 per QALY. The costs for progression-free survival of TAS102 group had the greatest impact on the ICERs, as well as the cost of TAS102.
CONCLUSION


Trifluridine/tipiracil (TAS102) is not a cost-effective choice for patients with heavily pretreated metastatic gastric cancer from an American payer perspective.",2020,"The costs for progression-free survival of TAS102 group had the greatest impact on the ICERs, as well as the cost of TAS102.
","['patients with heavily pretreated metastatic gastric cancer from an American payer perspective', 'heavily pretreated metastatic gastric cancer', 'patients with heavily pretreated advanced gastric cancer', 'heavily pretreated advanced gastric cancer']","['trifluridine/tipiracil (TAS102', 'Trifluridine/tipiracil (TAS102', 'placebo', 'TAS102']","['survival (PFS), progressive disease (PD) and death', 'incremental cost-effectiveness ratio (ICER', 'costs for progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278498', 'cui_str': 'Metastatic gastric cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}]","[{'cui': 'C0040987', 'cui_str': 'Trifluridine'}, {'cui': 'C4056441', 'cui_str': 'tipiracil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.237435,"The costs for progression-free survival of TAS102 group had the greatest impact on the ICERs, as well as the cost of TAS102.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37, GuoXue Xiang, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37, GuoXue Xiang, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37, GuoXue Xiang, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37, GuoXue Xiang, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, No. 37, GuoXue Xiang, Chengdu, 610041, Sichuan, China. fbqiu9@163.com.'}]",Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico,['10.1007/s12094-019-02127-6']
690,30021811,Expression network analysis reveals cord blood vitamin D-associated genes affecting risk of early life wheeze.,"Cord blood 25-hydroxyvitamin D (25OHD) has been reported in association with risk of early life recurrent wheeze. In a subset of infants who participated in the Vitamin D Antenatal Asthma Reduction Trial, we demonstrated that higher cord blood 25OHD at birth (>31 ng/mL) was associated with a reduced risk of recurrent wheeze in the first year of life. We then identified a module of co-expressed genes associated with cord blood 25OHD levels >31 ng/mL. Genes in this module are involved in biological and immune pathways related to development and progression of asthma pathogenesis including the Notch1 and transforming growth factor-beta signalling pathways.",2019,We then identified a module of co-expressed genes associated with cord blood 25OHD levels >31 ng/mL. Genes in this module are involved in biological and immune pathways related to development and progression of asthma pathogenesis including the Notch1 and transforming growth factor-beta signalling pathways.,[],[],"['higher cord blood 25OHD at birth', 'Cord blood 25-hydroxyvitamin D (25OHD']",[],[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",,0.166191,We then identified a module of co-expressed genes associated with cord blood 25OHD levels >31 ng/mL. Genes in this module are involved in biological and immune pathways related to development and progression of asthma pathogenesis including the Notch1 and transforming growth factor-beta signalling pathways.,"[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Amal A', 'Initials': 'AA', 'LastName': 'Al-Garawi', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Weiliang', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, New York, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Thorax,['10.1136/thoraxjnl-2018-211962']
691,31727664,"The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis.","INTRODUCTION


Rotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis.
METHODS AND ANALYSIS


This Bayesian adaptive clinical trial will investigate whether routinely scheduling an additional dose of Rotarix for Australian Indigenous children aged 6 to <12 months old confers significantly better protection against clinically important all-cause gastroenteritis than the current two-dose schedule at 2 and 4 months old. There are two coprimary endpoints: (1) seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre <20 U/mL prior to an additional dose of Rotarix/placebo to serum anti-rotavirus IgA titre >20 U/mL following the administration of the additional dose of Rotarix/placebo and (2) time from randomisation to medical attendance (up to age 36 months old) for which the primary reason is acute gastroenteritis/diarrhoea. Secondary endpoints include the change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification. Analysis will be based on Bayesian inference with adaptive sample size.
ETHICS, REGISTRATION AND DISSEMINATION


Ethics approval has been granted by Central Australian Human Research Ethics Committee (HREC-16-426) and Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2016-2658). Study investigators will ensure the trial is conducted in accordance with the principles of the Declaration of Helsinki and with the ICH Guidelines for Good Clinical Practice. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication. The trial is registered with Clinicaltrials.gov (NCT02941107) and important modifications to this protocol will be updated.
TRIAL REGISTRATION NUMBER


NCT02941107; Pre-results.",2019,"Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life.","['Australian Indigenous children aged 6 to <12 months old', 'Australian Indigenous infants']","['placebo', 'Rotarix/placebo', 'Rotarix rotavirus vaccine', 'oral human rotavirus vaccine (Rotarix, GlaxoSmithKline']","['change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification', 'protection against gastroenteritis', 'acute gastroenteritis/diarrhoea', 'seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre', 'serum anti-rotavirus IgA titre ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus (organism)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3476459', 'cui_str': 'Rotavirus IgA'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",,0.591793,"Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life.","[{'ForeName': 'Bianca Fleur', 'Initials': 'BF', 'LastName': 'Middleton', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia bianca.middleton@menzies.edu.au.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Jones', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Waddington', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Danchin', 'Affiliation': 'Vaccine and Immunisation Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'McCallum', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gallagher', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Amanda Jane', 'Initials': 'AJ', 'LastName': 'Leach', 'Affiliation': 'Child Health Division, Menzies School of Health Research, Charles Darwin Univesity, Darwin, Northern Territory, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Kirkwood', 'Affiliation': 'Enteric and Diarrheal Diseases, Bill and Melinda Gates Foundation, Seattle, Washington, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Cunliffe', 'Affiliation': 'Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Marsh', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, West Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032549']
692,31729550,Low dose fentanyl infusion versus 24% oral sucrose for pain management during laser treatment for retinopathy of prematurity-an open label randomized clinical trial.,"To compare the efficacy of low dose fentanyl infusion and 24% oral sucrose in providing optimal pain relief during laser for retinopathy of prematurity (ROP), we enrolled fifty-eight spontaneously breathing preterm infants undergoing laser. The preterm infants were randomized to either fentanyl infusion (1 mcg/kg/hr) or 24% oral sucrose (2 ml). We evaluated and compared the proportion of time spent crying during the procedure, salivary cortisol before and after the procedure, premature infant pain profile- revised (PIPP-R) scores during the procedure, apnoea during and after the procedure, need for mechanical ventilation, and feed intolerance and urinary retention 24 h after the procedure between the two groups. We found that the proportion of time spent crying during the procedure was significantly less in the fentanyl group [62.5% (50.7-74.2) vs 73.8% (55.6-83.4); P = 0.02]. Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of - 1.8; P = 0.01)]. There was no difference in other outcomes between the two groups.Conclusion: During laser for ROP, low dose fentanyl infusion was found to be efficacious in reducing pain as compared with 24% sucrose.What is Known:• Preterm infants undergoing laser photocoagulation for ROP suffer significant amount of pain.• Standard of care for pain relief in infants undergoing laser therapy in developed countries is general anesthesia (GA) or combination of sedation, analgesia, and paralysis (SAP).What is New:• During laser photocoagulation for ROP, fentanyl infusion at low dose (1 mcg/kg/hr) is efficacious in reducing pain as compared to 24% oral sucrose.",2020,Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of - 1.8; P = 0.01)].,"['infants undergoing', 'preterm infants', 'during laser for retinopathy of prematurity (ROP), we enrolled fifty-eight spontaneously breathing preterm infants undergoing laser', 'Known:• Preterm infants undergoing']","['fentanyl infusion versus 24% oral sucrose', 'fentanyl infusion (1 mcg/kg/hr) or 24% oral sucrose', 'laser therapy', 'fentanyl infusion and 24% oral sucrose', 'laser photocoagulation']","['premature infant pain profile- revised (PIPP-R) scores', 'optimal pain relief', 'pain', 'proportion of time spent crying', 'Average PIPP-R score', 'pain management']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1320752', 'cui_str': 'mcg/kg/hr'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",58.0,0.0523975,Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of - 1.8; P = 0.01)].,"[{'ForeName': 'Amanpreet', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'M Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India. jeevasankar@gmail.com.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Thukral', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Parijat', 'Initials': 'P', 'LastName': 'Chandra', 'Affiliation': 'Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, Room no.3058, Teaching block, Third floor, AIIMS, New Delhi, 110029, India.'}]",European journal of pediatrics,['10.1007/s00431-019-03514-5']
693,29896012,Femoral press-fit fixation versus interference screw fixation in anterior cruciate ligament reconstruction with bone-patellar tendon-bone autograft: 20-year follow-up.,"Introduction


The aim of this paper is to present our experience with femoral press-fit fixation in anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft.
Methods


The patient population was randomly placed in two groups: group A (58 patients), who underwent femoral screw fixation; group B (62 patients), who underwent femoral press-fit fixation.
Results


At last follow-up 9.2% of patients were lost; 28% of patients in group A and 64% of patients in group B had excellent International Knee Documentation Committee score (grade A); 66% of patients in group A and 32% of patients in group B had good International Knee Documentation Committee scores (grade B). The difference was statistically significant (p < 0.05).
Conclusions


Femoral press-fit fixation of bone- patellar tendon- bone autograft provides stable fixation at low cost, it ensures unlimited bone-to-bone healing and high primary stability, avoiding the disadvantages of hardware and the need for removal in case of revision.",2018,At last follow-up 9.2% of patients were lost; 28% of patients in group A and 64% of patients in group B had excellent International Knee Documentation Committee score (grade A); 66% of patients in group A and 32% of patients in group B had good International Knee Documentation Committee scores (grade B).,['anterior cruciate ligament reconstruction with bone-patellar tendon-bone autograft'],"['femoral screw fixation', 'anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft', 'Femoral press-fit fixation versus interference screw fixation', 'femoral press-fit fixation']","['excellent International Knee Documentation Committee score', 'good International Knee Documentation Committee scores']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C1444862', 'cui_str': 'Autogenous bone graft material'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C1444862', 'cui_str': 'Autogenous bone graft material'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation (qualifier value)'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",,0.0150248,At last follow-up 9.2% of patients were lost; 28% of patients in group A and 64% of patients in group B had excellent International Knee Documentation Committee score (grade A); 66% of patients in group A and 32% of patients in group B had good International Knee Documentation Committee scores (grade B).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Biazzo', 'Affiliation': 'Orthopaedic Department, ASST Gaetano Pini-CTO, via Bignami 1, 20126 Milano, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Manzotti', 'Affiliation': 'Orthopaedic Department, Ospedale Luigi Sacco, Via Giovanni Battista Grassi, 74, 20157 Milano, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Motavalli', 'Affiliation': 'Orthopaedic Department, ASST Gaetano Pini-CTO, via Bignami 1, 20126 Milano, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Confalonieri', 'Affiliation': 'Orthopaedic Department, ASST Gaetano Pini-CTO, via Bignami 1, 20126 Milano, Italy.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2018.02.010']
694,31032258,Integrated Myofibrillar Protein Synthesis in Recovery From Unaccustomed and Accustomed Resistance Exercise With and Without Multi-ingredient Supplementation in Overweight Older Men.,"Background:  We previously showed that daily consumption of a multi-ingredient nutritional supplement increased lean mass in older men, but did not enhance lean tissue gains during a high-intensity interval training (HIIT) plus resistance exercise training (RET) program. Here, we aimed to determine whether these divergent observations aligned with the myofibrillar protein synthesis (MyoPS) response to acute unaccustomed and accustomed resistance exercise.  Methods:  A sub-sample of our participants were randomly allocated ( n  = 15; age: 72 ± 7 years; BMI: 26.9 ± 3.1 kg/m 2  [mean ± SD]) to ingest an experimental supplement (SUPP,  n  = 8: containing whey protein, creatine, vitamin D, and n-3 PUFA) or control beverage (CON,  n  = 7: 22 g maltodextrin) twice per day for 21 weeks. After 7 weeks of consuming the beverage alone (Phase 1: SUPP/CON only), subjects completed 12 weeks of RET (twice per week) + HIIT (once per week) (Phase 2: SUPP/CON + EX). Orally administered deuterated water was used to measure integrated rates of MyoPS over 48 h following a single session of resistance exercise pre- (unaccustomed) and post-training (accustomed).  Results:  Following an acute bout of accustomed resistance exercise, 0-24 h MyoPS was 30% higher than rest in the SUPP group (effect size: 0.86); however, in the CON group, 0-24 h MyoPS was 0% higher than rest (effect size: 0.04). Nonetheless, no within or between group changes in MyoPS were statistically significant. When collapsed across group, rates of MyoPS in recovery from acute unaccustomed resistance exercise were positively correlated with training-induced gains in whole body lean mass ( r  = 0.63,  p  = 0.01).  Conclusion:  There were no significant between-group differences in MyoPS pre- or post-training. Integrated rates of MyoPS post-acute exercise in the untrained state were positively correlated with training-induced gains in whole body lean mass. Our finding that supplementation did not alter 0-48 h MyoPS following 12 weeks of training suggests a possible adaptive response to longer-term increased protein intake and warrants further investigation. This study was registered at ClinicalTrials.gov.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier: NCT02281331.",2019,Integrated rates of MyoPS post-acute exercise in the untrained state were positively correlated with training-induced gains in whole body lean mass.,"['Overweight Older Men', 'older men']","['Integrated Myofibrillar Protein Synthesis in Recovery From Unaccustomed and Accustomed Resistance Exercise', 'ingest an experimental supplement (SUPP,  n  = 8: containing whey protein, creatine, vitamin D, and n-3 PUFA) or control beverage (CON,  n  = 7: 22 g maltodextrin', 'resistance exercise pre- (unaccustomed) and post-training (accustomed', 'RET']","['MyoPS', 'lean mass', 'rates of MyoPS in recovery from acute unaccustomed resistance exercise']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0450404', 'cui_str': '22G (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.149687,Integrated rates of MyoPS post-acute exercise in the untrained state were positively correlated with training-induced gains in whole body lean mass.,"[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Bell', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Brook', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Snijders', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumbhare', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Parise', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'School of Graduate Entry Medicine and Health, University of Nottingham, Derby, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'School of Graduate Entry Medicine and Health, University of Nottingham, Derby, United Kingdom.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Exercise Metabolism Research Group, Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}]",Frontiers in nutrition,['10.3389/fnut.2019.00040']
695,30171334,Economic evaluation of a person-centred care intervention in head and neck oncology: results from a randomized controlled trial.,"PURPOSE


Head and neck cancer and its treatment deteriorate quality of life, but symptoms improve with person-centred care. We examined the cost-effectiveness of a person-centred care intervention versus standard medical care.
METHODS


In this randomized clinical trial of a person-centred intervention, patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1 year. Annual healthcare costs were identified from medical records and administrative register data. Productivity costs were calculated from reported sick leave. Health-related quality of life was collected using the EuroQol Group's five-dimension health state questionnaire.
RESULTS


Characteristics were similar between 53 patients in the intervention group and 39 control patients. The average total cost was Euro (EUR) 55,544 (95% confidence interval: EUR 48,474-62,614) in the intervention group and EUR 57,443 (EUR 48,607-66,279) among controls, with similar health-related quality of life.
CONCLUSIONS


This person-centred intervention did not result in increased costs and dominated the standard medical care.
TRIAL REGISTRATION


ClinicalTrials.gov (registration number: NCT02982746).",2019,"The average total cost was Euro (EUR) 55,544","['53 patients in the intervention group and 39 control patients', 'head and neck oncology', 'patients were planned for outpatient oncology treatment in a Swedish university hospital between 2012 and 2014 and were followed during 1\xa0year']","['person-centred care intervention versus standard medical care', 'person-centred care intervention', 'person-centred intervention']","['Annual healthcare costs', 'Productivity costs', 'Health-related quality of life', 'cost-effectiveness', 'average total cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.196076,"The average total cost was Euro (EUR) 55,544","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Centre for Person-centred Care (GPCC), University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden. hanna.gyllensten@gu.se.'}, {'ForeName': 'Ingalill', 'Initials': 'I', 'LastName': 'Koinberg', 'Affiliation': 'Centre for Person-centred Care (GPCC), University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Carlström', 'Affiliation': 'Centre for Person-centred Care (GPCC), University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Lars-Eric', 'Initials': 'LE', 'LastName': 'Olsson', 'Affiliation': 'Centre for Person-centred Care (GPCC), University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hansson Olofsson', 'Affiliation': 'Centre for Person-centred Care (GPCC), University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4436-2']
696,30975712,"Advance care planning and place of death, hospitalisation and actual place of death in lung, heart and cancer disease: a randomised controlled trial.","OBJECTIVES


Advance care planning (ACP) can be a way to meet patients' end-of-life preferences and enhance awareness of end-of-life care. Thereby it may affect actual place of death (APOD) and decrease the rate of hospitalisations. The aim was to investigate if ACP among terminally ill patients with lung, heart and cancer diseases effects fulfilment of preferred place of death (PPOD), amount of time spent in hospital and APOD.
METHODS


The study was designed as a randomised controlled trial. Patients were assessed using general and disease-specific criteria and randomised into groups: one received usual care and one received usual care plus ACP. The intervention consisted of a discussion between a healthcare professional, the patient and their relatives about preferences for end-of-life care. The discussion was documented in the hospital file.
RESULTS


In total, 205 patients were randomised, of which 111 died during follow-up. No significant differences in fulfilment of PPOD (35% vs 52%, p=0.221) or in amount of time spent in hospital among deceased patients (49% vs 23%, p=0.074) were found between groups. A significant difference in APOD was found favouring home death in the intervention group (17% vs 40%, p=0.013).
CONCLUSION


Concerning the primary outcome, fulfilment of PPOD, and the secondary outcome, time spent in hospital, no differences were found. A significant difference concerning APOD was found, as more patients in the intervention group died at home, compared with the usual care group.
TRIAL REGISTRATION NUMBER


NCT01944813.",2020,"A significant difference in APOD was found favouring home death in the intervention group (17% vs 40%, p=0.013).
","['lung, heart and cancer disease', 'terminally ill patients with lung, heart and cancer diseases effects fulfilment of preferred place of death (PPOD', '205 patients']","['Advance care planning (ACP', 'ACP', 'usual care and one received usual care plus ACP']","['time spent in hospital', 'fulfilment of PPOD', 'actual place of death (APOD', 'home death', 'APOD', 'rate of hospitalisations']","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1273399', 'cui_str': 'Preferred place of death'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0421611', 'cui_str': 'Place of death (observable entity)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",205.0,0.136916,"A significant difference in APOD was found favouring home death in the intervention group (17% vs 40%, p=0.013).
","[{'ForeName': 'Marianne Hjorth', 'Initials': 'MH', 'LastName': 'Skorstengaard', 'Affiliation': 'Clinical Medicine, Aarhus Universitet, Aarhus, Denmark marianne.skorstengaard@viborg.rm.dk.'}, {'ForeName': 'Anders Bonde', 'Initials': 'AB', 'LastName': 'Jensen', 'Affiliation': 'Oncology Department, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Andreassen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Brogaard', 'Affiliation': 'Research Unit for General Practice, Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Brendstrup', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Løkke', 'Affiliation': 'Department of Respiratory Diseases and Allergy, Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Aagaard', 'Affiliation': 'Department of Cardiology, Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus Universitetshospital, Aarhus, Denmark.'}, {'ForeName': 'Mette Asbjoern', 'Initials': 'MA', 'LastName': 'Neergaard', 'Affiliation': 'The Palliative Care Team, Oncology Department, Aarhus University Hospital, Aarhus, Denmark.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2018-001677']
697,30924702,"A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD.","Objective:  The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years.  Method:  In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting.  Results:  Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p  < .05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly ( p  < .05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite.  Conclusion:  SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.",2020,"RESULTS


Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p < .05; effect size [ES] = 0.547, 0.596, and 0.623).","['Children With ADHD', 'children aged 6 to 12 years', '222 participants were randomized to']","['SPN-812 (extended-release viloxazine', 'placebo', 'SPN-812 (Extended-Release Viloxazine', 'Placebo', 'SPN-812', 'placebo or SPN-812']","['CGI-S score', 'tolerated', 'laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting', 'CGI-I score', 'ADHD-RS-IV total score', 'somnolence, headache, and decreased appetite', 'severity of ADHD symptoms', 'ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",222.0,0.105641,"RESULTS


Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p < .05; effect size [ES] = 0.547, 0.596, and 0.623).","[{'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Liranso', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Saylor', 'Affiliation': 'NeuroScience, Inc., Herndon, VA, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Tulloch', 'Affiliation': 'Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Adewole', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwabe', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nasser', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of attention disorders,['10.1177/1087054719836159']
698,29888205,"Regional Differences in Efficacy, Safety, and Biomarkers for Second-Line Axitinib in Patients with Advanced Hepatocellular Carcinoma: From a Randomized Phase II Study.","Background


An unmet need exists for treatment of patients with advanced hepatocellular carcinoma (HCC) who progress on or are intolerant to sorafenib. A global randomized phase II trial (ClinicalTrial.gov No. NCT01210495) of axitinib, a vascular endothelial growth factor receptor 1-3 inhibitor, in combination with best supportive care (BSC) did not prolong overall survival (OS) over placebo/BSC, but showed improved progression-free survival in some patients. Subgroup analyses were conducted to identify potential predictive/prognostic factors.
Methods


The data from this phase II study were analyzed for the efficacy and safety of axitinib/BSC in patients from Asia versus non-Asia versus Asian subgroups (Japan, Korea, or mainland China/Hong Kong/Taiwan) and predictive/prognostic values of baseline microRNAs and serum soluble proteins, using the Cox proportional hazards model.
Results


Of 202 patients, 78 were from non-Asia and 124 from Asia (37 Japanese, 36 Korean, and 51 Chinese). No significant differences in OS were found between axitinib/BSC and placebo/BSC in non-Asians, Asians, or Asian subgroups. However, in an exploratory analysis, axitinib/BSC showed favorable OS in Asians, especially Japanese, when patients intolerant to prior antiangiogenic therapy were excluded from the data set. Axitinib/BSC was well tolerated by non-Asians and Asians alike. The presence of 4 circulating microRNAs, including miR-5684 and miR-1224-5p, or a level lower than or equal to the median protein level of stromal cell-derived factor 1 at baseline was significantly associated with longer OS in axitinib/BSC-treated Asians or non-Asians.
Conclusions


Axitinib/BSC did not prolong survival over placebo/BSC in non-Asians, Asians, or Asian subgroups, but favorable OS with axitinib/BSC was observed in a subset of Japanese patients. A patient population that excludes sorafenib-intolerant patients might potentially be more suitable for clinical trials of new agents in advanced HCC. Since these results are very preliminary, further investigation is warranted. The potential predictive/prognostic value of several baseline microRNAs and soluble proteins identified in this study would require validation in prospective studies on a large cohort of patients.",2018,"No significant differences in OS were found between axitinib/BSC and placebo/BSC in non-Asians, Asians, or Asian subgroups.","['Patients with Advanced Hepatocellular Carcinoma', '202 patients, 78 were from non-Asia and 124 from Asia (37 Japanese, 36 Korean, and 51 Chinese', 'patients from Asia versus non-Asia versus Asian subgroups (Japan, Korea, or mainland China/Hong Kong/Taiwan', 'patients with advanced hepatocellular carcinoma (HCC']","['Axitinib/BSC', 'placebo/BSC']","['survival', 'OS', 'progression-free survival', 'overall survival (OS', 'efficacy and safety of axitinib/BSC', 'Efficacy, Safety, and Biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",202.0,0.0265342,"No significant differences in OS were found between axitinib/BSC and placebo/BSC in non-Asians, Asians, or Asian subgroups.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Center for Liver Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Department of Medical Oncology, Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Assenat', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint Eloi, Montpellier, France.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Umeyama', 'Affiliation': 'Pfizer Japan Inc., Tokyo, Japan.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Lechuga', 'Affiliation': 'Pfizer Srl, Milan, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Valota', 'Affiliation': 'Pfizer Srl, Milan, Italy.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Fujii', 'Affiliation': 'Pfizer Japan Inc., Tokyo, Japan.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Williams', 'Affiliation': 'Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Obi', 'Affiliation': 'Department of Hepatology, Sasaki Foundation Kyoundo Hospital, Tokyo, Japan.'}]",Liver cancer,['10.1159/000484620']
699,30761523,"Neprilysin inhibition for pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled, proof-of-concept trial.","BACKGROUND AND PURPOSE


Pulmonary arterial hypertension (PAH) is an incurable, incapacitating disorder resulting from increased pulmonary vascular resistance, pulmonary arterial remodelling, and right ventricular failure. In preclinical models, the combination of a PDE5 inhibitor (PDE5i) with a neprilysin inhibitor augments natriuretic peptide bioactivity, promotes cGMP signalling, and reverses the structural and haemodynamic deficits that characterize PAH. Herein, we conducted a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of repurposing the neprilysin inhibitor, racecadotril, in PAH.
EXPERIMENTAL APPROACH


Twenty-one PAH patients stable on PDE5i therapy were recruited. Acute haemodynamic and biochemical changes following a single dose of racecadotril or matching placebo were determined; this was followed by a 14-day safety and efficacy evaluation. The primary endpoint in both steps was the maximum change in circulating atrial natriuretic peptide (ANP) concentration (Δ max  ), with secondary outcomes including pulmonary and systemic haemodynamics plus mechanistic biomarkers.
KEY RESULTS


Acute administration of racecadotril (100 mg) resulted in a 79% increase in the plasma ANP concentration and a 106% increase in plasma cGMP levels, with a concomitant 14% fall in pulmonary vascular resistance. Racecadotril (100 mg; t.i.d.) treatment for 14 days resulted in a 19% rise in plasma ANP concentration. Neither acute nor chronic administration of racecadotril resulted in a significant drop in mean arterial BP or any serious adverse effects.
CONCLUSIONS AND IMPLICATIONS


This Phase IIa evaluation provides proof-of-principle evidence that neprilysin inhibitors may have therapeutic utility in PAH and warrants a larger scale prospective trial.",2019,"Neither acute nor chronic administration of racecadotril resulted in a significant drop in mean arterial BP or any serious adverse effects.
","['Twenty-one PAH patients stable on PDE5i therapy were recruited', 'pulmonary arterial hypertension']","['placebo', 'racecadotril or matching placebo', 'Racecadotril', 'Neprilysin inhibition', 'racecadotril', 'PDE5 inhibitor (PDE5i']","['plasma cGMP levels', 'plasma ANP concentration', 'mean arterial BP or any serious adverse effects', 'pulmonary vascular resistance', 'efficacy and safety', 'maximum change in circulating atrial natriuretic peptide (ANP) concentration (Δ max  ), with secondary outcomes including pulmonary and systemic haemodynamics plus mechanistic biomarkers']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0050461', 'cui_str': 'racecadotril'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",21.0,0.648475,"Neither acute nor chronic administration of racecadotril resulted in a significant drop in mean arterial BP or any serious adverse effects.
","[{'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Hobbs', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Amie J', 'Initials': 'AJ', 'LastName': 'Moyes', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Reshma S', 'Initials': 'RS', 'LastName': 'Baliga', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dipa', 'Initials': 'D', 'LastName': 'Ghedia', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ochiel', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Sylvestre', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kashfia', 'Initials': 'K', 'LastName': 'Chowdhury', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maclagan', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Quartly', 'Affiliation': 'Comprehensive Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Reecha', 'Initials': 'R', 'LastName': 'Sofat', 'Affiliation': 'Centre for Clinical Pharmacology, Rayne Institute, London, UK.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Smit', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Schreiber', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Gerry J', 'Initials': 'GJ', 'LastName': 'Coghlan', 'Affiliation': 'Department of Cardiology, Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'MacAllister', 'Affiliation': 'Dorset County Hospital NHS Foundation Trust, Dorset, UK.'}]",British journal of pharmacology,['10.1111/bph.14621']
700,31719052,No excess harms from sustained-release morphine: a randomised placebo-controlled trial in chronic breathlessness.,"OBJECTIVES


We aimed to identify and evaluate: (1) treatment-emergent adverse events (TEAE (worse or new since baseline)) and the subgroup of severe TEAEs in a placebo-controlled 7-day randomised trial of regular, low-dose, sustained-release oral morphine for chronic breathlessness and (2) clinical characteristics associated with TEAE.
METHODS


Safety analysis of trial data. Adults with chronic breathlessness (modified Medical Research Council breathlessness score ≥2) due to heart or lung disease, or cancer, not on regular opioids were eligible. Symptoms associated with opioids (TEAE of special interest) were systematically sought using Common Terminology Criteria for Adverse Events (CTCAE) grading. Other harms could be reported at any time. The relationship between characteristics and presence of ≥1 TEAE of special interest was explored using univariable logistic regression analyses.
RESULTS


1449/5624 (26%) Adverse Events from 279 participants were TEAE of which 150/1449 (10%) were severe (CTCAE grades 3-5). 1086/5624 (75%) were events of special interest of which 41/1086 (4%) were severe. Compared with placebo, morphine was not associated with more TEAE or severe TEAE of special interest (TEAE: OR 0.53, 95% CI 0.21 to 1.38, p=0.20; severe TEAE: OR 0.96, 95% CI 0.27 to 3.41, p=0.95) nor with CTCAE severity grade (χ 2 =4.39, p=0.50). Among the 26/150 (17%) with severe TEAEs, study withdrawal was more common in the morphine arm (18/26 (69%) morphine arm; 8/26 (30%) placebo arm). None of the severe TEAEs was a respiratory harm.
CONCLUSIONS


Severe morphine-associated toxicity was uncommon and not associated with study arm. Clinical consequences were minor and self-limiting.
TRIAL REGISTRATION NUMBER


ACTRN126000806268.",2020,"Among the 26/150 (17%) with severe TEAEs, study withdrawal was more common in the morphine arm (18/26 (69%) morphine arm; 8/26 (30%) placebo arm).","['279 participants were TEAE of which 150/1449 (10%) were severe (CTCAE grades 3-5', 'chronic breathlessness', 'Adults with chronic breathlessness (modified Medical Research Council breathlessness score ≥2) due to heart or lung disease, or cancer, not on regular opioids were eligible']","['placebo', 'morphine', 'placebo, morphine', 'regular, low-dose, sustained-release oral morphine']",['toxicity'],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1519275', 'cui_str': 'CTCAE grade 3'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",279.0,0.341108,"Among the 26/150 (17%) with severe TEAEs, study withdrawal was more common in the morphine arm (18/26 (69%) morphine arm; 8/26 (30%) placebo arm).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK miriam.johnson@hyms.ac.uk.'}, {'ForeName': 'Illary', 'Initials': 'I', 'LastName': 'Sbizzera', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekstrom', 'Affiliation': 'Department of Medicine, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2019-002009']
701,32407060,A split-mouth study comparing piezo electric surgery and traditional rotary burs on impacted third molars in young patients: an intraoperative and postoperative evaluation.,"BACKGROUND


Piezoelectric surgery has been used in many different medical fields, for instance it is used in the field of oral surgery, as a valuable alternative to traditional rotary burs. Its first use dates to 1975 by Horton even if the first effective device for use in dentistry, has been developed by Vercellotti after the year 2000. The hypothesis of this study is that piezosurgery technology is more suitable in terms of specific intra-operative and postoperative evaluations compared to the rotary technology in ostectomy for the avulsion of the third molar germ. The null hypothesis presented is the lack of significant differences between the two technologies after and during surgery.
METHODS


Intraoperative and postoperative aspects are evaluated for a comparison between traditional rotary instruments and piezosurgery during germectomies in young patients through a blind randomized study (split-mouth). The surgical technique to employ for each hemi-arch was randomly selected from a computer algorithm. Different criteria were considered during the surgical procedure, in order to compare the two techniques.
RESULTS


The piezoelectric technique demanded more time than traditional rotary method, and the difference was statistically significant both for the time of the entire procedure and the time only required for the ostectomy itself. Postoperative evaluations such as maximum mouth opening, facial swelling and postoperative pain showed no statistical difference.
CONCLUSIONS


Even if the adopted clinical trial did not highlight any statistical difference the following review of literature showed an encouraging reduction in postoperative discomfort given by the piezosurgery as opposed to the traditional rotary bur surgery. The time taken to complete the operation, however, was longer with piezosurgery compared to traditional burs.",2020,"The piezoelectric technique demanded more time than traditional rotary method, and the difference was statistically significant both for the time of the entire procedure and the time only required for the ostectomy itself.",['young patients'],['piezo electric surgery and traditional rotary burs'],"['maximum mouth opening, facial swelling and post- operative pain']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0700351', 'cui_str': 'Bur'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.0339926,"The piezoelectric technique demanded more time than traditional rotary method, and the difference was statistically significant both for the time of the entire procedure and the time only required for the ostectomy itself.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zara', 'Affiliation': 'Unit of Pediatric Dentistry, D.A.I Testa-Collo, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy - zarafrancesca94@gmail.com.'}, {'ForeName': 'Claudio M', 'Initials': 'CM', 'LastName': 'De Sanctis', 'Affiliation': 'Unit of Pediatric Dentistry, D.A.I Testa-Collo, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Fabia C', 'Initials': 'FC', 'LastName': 'Dede', 'Affiliation': 'Unit of Pediatric Dentistry, D.A.I Testa-Collo, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Bossù', 'Affiliation': 'Unit of Pediatric Dentistry, D.A.I Testa-Collo, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Gian L', 'Initials': 'GL', 'LastName': 'Sfasciotti', 'Affiliation': 'Unit of Pediatric Dentistry, D.A.I Testa-Collo, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}]",Minerva stomatologica,['10.23736/S0026-4970.20.04349-6']
702,31719675,Longitudinal neovascular changes on optical coherence tomography angiography in proliferative diabetic retinopathy treated with panretinal photocoagulation alone versus with intravitreal conbercept plus panretinal photocoagulation: a pilot study.,"PURPOSE


To investigate the longitudinal changes in neovascularization of the retinal elsewhere (NVE) size on optical coherence tomography angiography (OCTA) in proliferative diabetic retinopathy (PDR) treated by panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP.
METHODS


A prospective pilot study. Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included. They were assigned to receive PRP alone (PRP group) or intravitreal conbercept injection plus PRP (combination group). Ophthalmic examinations, including BCVA and OCTA to measure the NVE size, were performed at baseline before each PRP session, and at 1, 3, and 6 months.
RESULTS


Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group. There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline. In both groups, there was a significant (P < 0.05) NVE size reduction during the majority of study visits, with the reduction observed in the combination group significantly larger than that in the PRP group. No significant BCVA changes were observed in either groups, except that in the PRP group, the BCVA at 3 months was significantly improved (P < 0.05). No deaths or unexpected adverse events (AEs) were reported.
CONCLUSIONS


Intravitreal conbercept plus PRP was more effective than PRP monotherapy in NVE regression. Precise quantification of the NVE area by OCTA makes it a useful tool for monitoring the response of retinal neovascular lesions to the therapy.",2020,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","['proliferative diabetic retinopathy treated with', 'Forty-four PDR eyes with NVE confirmed by fundus fluorescein angiography (FFA) and OCTA were included', 'proliferative diabetic retinopathy (PDR', 'Twenty-nine eyes were included in the PRP group, and 15 eyes were included in the combination group']","['optical coherence tomography angiography', 'intravitreal conbercept plus panretinal photocoagulation', 'PRP alone (PRP group) or intravitreal conbercept injection plus PRP', 'panretinal photocoagulation alone', 'panretinal photocoagulation (PRP) alone or by single intravitreal conbercept injection plus PRP', 'optical coherence tomography angiography (OCTA']","['No deaths or unexpected adverse events (AEs', 'NVE size reduction', 'BCVA changes', 'BCVA and OCTA to measure the NVE size', 'BCVA']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0430878', 'cui_str': 'Retinal angiography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",44.0,0.0175467,"There was no significant difference between the two groups with respect to age, BCVA, and NVE area at baseline.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Peking Union Medical College Hospital, Key Lab of Ocular Fundus Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. yuweihongeye@foxmail.com.'}]","Eye (London, England)",['10.1038/s41433-019-0628-3']
703,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2']
704,32410722,"Targeted outdoor residual spraying, autodissemination devices and their combination against  Aedes  mosquitoes: field implementation in a Malaysian urban setting.","Currently, dengue control relies largely on reactive vector control programmes. Proactive vector-control using a rational, well-balanced integrated vector management approach may prove more successful for dengue control. As part of the development of a cluster randomized controlled epidemiological trial, a study was conducted in Johor Bahru, Malaysia. The study included one control site (three buildings) and three intervention sites which were treated as follows: targeted outdoor residual spraying only (TORS site, two buildings); deployment of autodissemination devices only (ADD site, four buildings); and the previous two treatments combined (TORS + ADD site, three buildings). The primary entomological measurement was per cent of positive ovitraps-ovitrap index (OI). The effect of each intervention on OI was analyzed by a modified ordinary least squares regression model. Relative to the control site, the TORS and ADD sites showed a reduction in the Aedes OI (-6.5%, P = 0.04 and -8.3%, P = 0.10, respectively). Analysis by species showed that, relative to control, the Ae. aegypti OI was lower in ADD (-8.9%, P = 0.03) and in TORS (-10.4%, P = 0.02). No such effect was evident in the TORS + ADD site. The present study provides insights into the methods to be used for the main trial. The combination of multiple insecticides with different modes of action in one package is innovative, although we could not demonstrate the additive effect of TORS + ADD. Further work is required to strengthen our understanding of how these interventions impact dengue vector populations and dengue transmission.",2020,"aegypti OI was lower in ADD (-8.9%, P = 0.03) and in TORS (-10.4%, P = 0.02).",['Malaysian urban setting'],"['outdoor residual spraying only (TORS site, two buildings); deployment of autodissemination devices only (ADD site, four buildings); and the previous two treatments combined (TORS + ADD site, three buildings', 'Targeted outdoor residual spraying, autodissemination devices and their combination against']","['per cent of positive ovitraps-ovitrap index (OI', 'TORS', 'aegypti OI']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0521124', 'cui_str': 'Against'}]","[{'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0233349,"aegypti OI was lower in ADD (-8.9%, P = 0.03) and in TORS (-10.4%, P = 0.02).","[{'ForeName': 'Nurulhusna Ab', 'Initials': 'NA', 'LastName': 'Hamid', 'Affiliation': 'Medical Entomology Unit, Institute for Medical Research, WHO Collaborating Centre, Institute for Medical Research, Ministry of Health Malaysia, Jalan Pahang, 50588Kuala Lumpur, Malaysia.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, United Kingdom.'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Suer', 'Affiliation': 'In2Care B.V., Marijkeweg 22, 6871SE Wageningen, the Netherlands.'}, {'ForeName': 'Nazni Wasi', 'Initials': 'NW', 'LastName': 'Ahmed', 'Affiliation': 'Medical Entomology Unit, Institute for Medical Research, WHO Collaborating Centre, Institute for Medical Research, Ministry of Health Malaysia, Jalan Pahang, 50588Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rose Nani', 'Initials': 'RN', 'LastName': 'Mudin', 'Affiliation': 'Vector Borne Disease Sector, Disease Control Division, Federal Government Administrative Center, Ministry of Health Malaysia, Level 4, Block E10, Complex E, 62590Putrajaya, Malaysia.'}, {'ForeName': 'Topek', 'Initials': 'T', 'LastName': 'Omar', 'Affiliation': 'Vector Borne Disease Sector, Disease Control Division, Federal Government Administrative Center, Ministry of Health Malaysia, Level 4, Block E10, Complex E, 62590Putrajaya, Malaysia.'}, {'ForeName': 'Rahmat', 'Initials': 'R', 'LastName': 'Dapari', 'Affiliation': 'Vector Borne Disease Sector, Disease Control Division, Federal Government Administrative Center, Ministry of Health Malaysia, Level 4, Block E10, Complex E, 62590Putrajaya, Malaysia.'}, {'ForeName': 'Shahrom Nor Azian', 'Initials': 'SNA', 'LastName': 'Che Mat Din', 'Affiliation': 'Public Health Division, Johor, Johor State Health Department, Ministry of Health Malaysia, Jalan Persiaran Permai, 81200Johor Bahru Johor, Malaysia.'}, {'ForeName': 'Roslinda Abdul', 'Initials': 'RA', 'LastName': 'Rahman', 'Affiliation': 'Public Health Division, Johor, Johor State Health Department, Ministry of Health Malaysia, Jalan Persiaran Permai, 81200Johor Bahru Johor, Malaysia.'}, {'ForeName': 'Ropiah', 'Initials': 'R', 'LastName': 'Jaraee', 'Affiliation': 'Entomology and Pest Unit Public Health Division, Johor, Johor State Health Department, Ministry of Health Malaysia, Jalan Persiaran Permai, 81200Johor Bahru Johor, Malaysia.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Baur', 'Affiliation': 'Bayer S.A.S, Environmental Science, Crop Science Division, 16 rue Jean Marie Leclair; 69266 Lyon Cedex 09, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Schmitt', 'Affiliation': 'Bayer S.A.S, Environmental Science, Crop Science Division, 16 rue Jean Marie Leclair; 69266 Lyon Cedex 09, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Hamon', 'Affiliation': 'Innovative Vector Control Consortium, Pembroke Place, L3 5QA, Liverpool, UK.'}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Richardson', 'Affiliation': 'Innovative Vector Control Consortium, Pembroke Place, L3 5QA, Liverpool, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Langlois-Jacques', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique et Bioinformatique, F-69003 Lyon, France; Université de Lyon, F-69000 Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100Villeurbanne, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Rabilloud', 'Affiliation': 'Hospices Civils de Lyon, Service de Biostatistique et Bioinformatique, F-69003 Lyon, France; Université de Lyon, F-69000 Lyon, France; Université Lyon 1, F-69100 Villeurbanne, France; CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, F-69100Villeurbanne, France.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Saadatian-Elahi', 'Affiliation': ""Service d'Hygiène, Epidémiologie et Prévention, Hospices Civils de Lyon, F-69437Lyon, France and Laboratoire des Pathogènes Emergents - Fondation Mérieux, Centre International de Recherche en Infectiologie, Institut National de la Santé et de la Recherche Médicale U1111, Centre National de la Recherche Scientifique, UMR5308, Ecole Normale Supérieure de Lyon, Université Claude Bernard Lyon 1, 21, Avenue Tony Garnier, 69007Lyon, France.""}]",Bulletin of entomological research,['10.1017/S0007485320000188']
705,29467437,Accelerated repetitive transcranial magnetic stimulation in the treatment of depression.,"Repetitive transcranial magnetic stimulation (rTMS) is increasingly used clinically in the treatment of patients with major depressive disorder (MDD). However, rTMS treatment response can be slow. Early research suggests that accelerated forms of rTMS may be effective but no research has directly evaluated a schedule of accelerated rTMS compared to standard rTMS. To assess the efficacy of accelerated rTMS compared to standard daily rTMS., 115 outpatients with MDD received either accelerated rTMS (n = 58) (i.e., 63,000 high frequency rTMS pulses delivered as 3 treatments per day over 3 days in week 1, 3 treatments over 2 days in week 2 and 3 treatments on a single day in week 3) or standard rTMS (n = 57) (i.e., 63,000 total high frequency rTMS pulses delivered over 5 days per week for 4 weeks) following randomization. There were no significant differences in remission or response rates (p > 0.05 for all analyses) or reduction in depression scores (Time by group interaction (F (5, 489.452) = 1.711, p = 0.130) between the accelerated and standard rTMS treatment groups. Accelerated treatment was associated with a higher rate of reported treatment discomfort. It is feasible to provide accelerated rTMS treatment for outpatients with depression and this is likely to produce meaningful antidepressant effects.",2018,"There were no significant differences in remission or response rates (p > 0.05 for all analyses) or reduction in depression scores (Time by group interaction (F (5, 489.452) = 1.711, p = 0.130) between the accelerated and standard rTMS treatment groups.","['115 outpatients with MDD received either', 'patients with major depressive disorder (MDD', 'outpatients with depression']","['accelerated rTMS', 'standard rTMS', 'Accelerated repetitive transcranial magnetic stimulation', 'Repetitive transcranial magnetic stimulation (rTMS', 'rTMS']","['remission or response rates', 'depression scores']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",115.0,0.014864,"There were no significant differences in remission or response rates (p > 0.05 for all analyses) or reduction in depression scores (Time by group interaction (F (5, 489.452) = 1.711, p = 0.130) between the accelerated and standard rTMS treatment groups.","[{'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Healthcare, The Epworth Clinic, Camberwell, Victoria, Australia. paul.fitzgerald@monash.edu.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Elliot', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Victoria, Australia.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Susan McQueen', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Lenore E', 'Initials': 'LE', 'LastName': 'Wambeek', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Victoria, Australia.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-018-0009-9']
706,30659420,Efficacy and Safety of Premixed Human Insulin Combined with Sulfonylureas in Type 2 Diabetic Patients Previously Poorly Controlled with Insulin.,"INTRODUCTION


Some type 2 diabetes (T2DM) patients treated with premixed insulin alone or in combination with oral glucose-lowering agents (without sulfonylureas) cannot reach the required glucose targets. Clinical studies have demonstrated that diabetes patients treated with sulfonylureas achieve stable glycemic control, with a low hypoglycemic rate. The aim of our study was to evaluate the efficacy and safety of therapy with the combination of premixed insulin and sulfonylureas.
METHODS


A total of 120 patients with T2DM who were unable to achieve glycemic control on premixed human insulin were randomized into four groups, namely, a control group (premixed human insulin only) and three groups receiving combination therapy with premixed human insulin and one of the following sulfonylureas: gliclazide sustained release tablets [Diamicron], glipizide extended release tablets [Glucotrol XL], and glimepiride medium-to-long-acting tablets [Amaryl], with 30 patients in each group. Hemoglobin A1c, blood glucose, and adverse events were assessed at baseline and at the end of the 12-week treatment period.
RESULTS


After treatment for 12 weeks, HbA1c, fasting glucose, and 2-h postprandial glucose levels in the four groups were significantly decreased when compared with baseline (P < 0.05). However, there was no difference between the four groups at the end of the study. In the control group, the daily insulin dose had been significantly increased at the end of the follow-up when compared with baseline (P  < 0.05), while there were no significant changes in premixed insulin dose in the three combination therapy groups. There were no significant differences in adverse events among the four groups.
CONCLUSION


Insulin combined with sulfonylureas could improve glycemic control without increasing daily insulin dose and adverse events. Based on our results, we consider the combination of premixed insulin and sulfonylureas to be effective and safe for the treatment of T2DM.
TRIAL REGISTRATION


This trial was registered as ChiCTR-TRC-14004751. Trial Registration Date: 5 June 2014.",2019,"There were no significant differences in adverse events among the four groups.
","['diabetes patients treated with', '120 patients with T2DM who were unable to achieve glycemic control on premixed human insulin', 'Type 2 Diabetic Patients Previously Poorly Controlled with Insulin']","['premixed insulin and sulfonylureas', 'sulfonylureas', 'glimepiride medium-to-long-acting tablets [Amaryl', 'control group (premixed human insulin only) and three groups receiving combination therapy with premixed human insulin and one of the following sulfonylureas: gliclazide sustained release tablets [Diamicron], glipizide extended release tablets [Glucotrol XL', 'Insulin combined with sulfonylureas', 'premixed insulin alone or in combination with oral glucose-lowering agents (without sulfonylureas', 'Premixed Human Insulin Combined with Sulfonylureas']","['HbA1c, fasting glucose, and 2-h postprandial glucose levels', 'adverse events', 'Hemoglobin A1c, blood glucose, and adverse events', 'Efficacy and Safety', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0595112', 'cui_str': 'Amaryl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0017642', 'cui_str': 'Glipizide'}, {'cui': 'C0701228', 'cui_str': 'Glucotrol'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0328155,"There were no significant differences in adverse events among the four groups.
","[{'ForeName': 'Ying-Hua', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Hui-Zhi', 'Initials': 'HZ', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Zhao-Sheng', 'Initials': 'ZS', 'LastName': 'Tang', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China. wh1762@easthospital.cn.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': ""Department of Endocrinology, East Hospital, Tongji University, Shanghai, 200120, People's Republic of China. fengbo2010@sohu.com.""}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0564-z']
707,30151681,Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study.,"Chemotherapy-induced peripheral neuropathy (CIPN) occurs in approximately 68% of patients who receive neurotoxic chemotherapy and lasts at least 6 months post-chemotherapy in approximately 30% of individuals. CIPN is associated with decreased quality of life and functional impairments. Evidence suggests that CIPN symptoms are caused, in part, by enhanced excitability and impaired inhibition in the central nervous system. Transcutaneous electrical nerve stimulation (TENS) decreases pain by counteracting both of these mechanisms and is efficacious in other conditions associated with neuropathic pain. This single-arm study (n = 29) assessed the feasibility of investigating TENS for CIPN after chemotherapy completion using a wireless, home-based TENS device. Eighty-one percent of eligible patients who were approached enrolled, and 85% of participants who received the TENS device completed the primary (6-week) study term. Qualitative interview data suggest that use of the device on the continuous setting that automatically alternates between 1-h stimulation and rest periods for 5 h/day would be acceptable to most participants. Significant (i.e., p < 0.05) improvements were observed with the EORTC-CIPN20 (percent change from baseline: 13%), SF-MPQ-2 (52%), numeric rating scale of pain (38%), tingling (30%), numbness (20%), and cramping (53%), and UENS large fiber sensation subscore (48%). Preliminary data that support the reliability and construct validity of the UENS for CIPN in cancer survivors are also provided. Together these data suggest that it is feasible to evaluate TENS for CIPN using a wireless, home-based device and that further evaluation of TENS for CIPN in a randomized clinical trial is warranted.",2019,"Significant (i.e., p < 0.05) improvements were observed with the EORTC-CIPN20 (percent change from baseline: 13%), SF-MPQ-2 (52%),","['chemotherapy-induced peripheral neuropathy', 'Eighty-one percent of eligible patients who were approached enrolled, and 85% of participants who received the TENS device completed the primary (6-week) study term', 'cancer survivors']","['Wireless transcutaneous electrical nerve stimulation device', 'neurotoxic chemotherapy', 'UENS', 'Transcutaneous electrical nerve stimulation (TENS', 'CIPN']","['tingling', 'numbness', 'UENS large fiber sensation subscore', 'peripheral neuropathy (CIPN', 'numeric rating scale of pain', 'EORTC-CIPN20', 'SF-MPQ-2', 'quality of life and functional impairments']","[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2242996', 'cui_str': 'Tingling'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.0680276,"Significant (i.e., p < 0.05) improvements were observed with the EORTC-CIPN20 (percent change from baseline: 13%), SF-MPQ-2 (52%),","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gewandter', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, USA. jennifer_gewandter@urmc.rochester.edu.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Chaudari', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Chinazom', 'Initials': 'C', 'LastName': 'Ibegbu', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kitt', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Serventi', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kolb', 'Affiliation': 'Department of Neurology, University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Mohamedtaki A', 'Initials': 'MA', 'LastName': 'Tejani', 'Affiliation': 'Department of Medicine, Hematology/Oncology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Nimish A', 'Initials': 'NA', 'LastName': 'Mohile', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4424-6']
708,31707814,Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial.,"BACKGROUND


Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents.
METHODS


We carried out a randomized double-blind placebo-controlled trial in the Children's Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents.
RESULTS


A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: -8.0; 95% confidence interval (CI): -9.3 to -6.6), sodium valproate (difference: -8.3; 95% confidence interval: -9.3 to -7.2), and placebo (difference: -4.4; 95% confidence interval: -5.4 to -3.4) arms. The decrease was statistically greater in cinnarizine (difference: -3.6; 95% confidence interval: -5.5 to -1.6) and sodium valproate (difference: -3.9; 95% confidence interval: -5.8 to -1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: -4.6; 95% confidence interval: -5.2 to -4.0; sodium valproate: -4.0; 95% confidence interval: -4.8 to -3.3; placebo: -2.6; 95% confidence interval: -3.4 to -1.8). The decrease was statistically greater in cinnarizine (difference: -2.0; 95% confidence interval: -3.2 to -0.8) and sodium valproate (difference: -1.5; 95% confidence interval: -2.7 to -0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation.
CONCLUSION


Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents.  Trial registration:  IRCT201206306907N4.",2020,The odds ratio for >50% responder rate was 3.5,"[""Children's Medical Center and Sina hospital, Tehran, Iran"", 'pediatric migraine', '158 children participated', 'children and adolescents', 'Eligible participants']","['cinnarizine and sodium valproate', 'Cinnarizine and sodium valproate', 'placebo', 'sodium valproate versus placebo', 'cinnarizine', 'sodium valproate', 'cinnarizine, sodium valproate, or placebo']","['efficacy of each drug in the prevention of migraine', 'frequency of migraine attacks', 'migraine frequency', 'mean change in frequency and intensity of migraine attacks', 'safety and efficacy', 'intensity of episodes', 'adverse effects']","[{'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0008803', 'cui_str': 'Cinnarizine'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",158.0,0.759863,The odds ratio for >50% responder rate was 3.5,"[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Amanat', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mansoureh', 'Initials': 'M', 'LastName': 'Togha', 'Affiliation': 'Department of Neurology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Department of Neurology, Loghman Hakim Hospital, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Tavasoli', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Azizi Malamiri', 'Affiliation': 'Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Fashandaky', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Eshaghi', 'Affiliation': ""Department of Paediatric Infectious Disease, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mahmoud Reza', 'Initials': 'MR', 'LastName': 'Ashrafi', 'Affiliation': ""Pediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}]",Cephalalgia : an international journal of headache,['10.1177/0333102419888485']
709,30879366,Continuous versus interrupted use of vaginal probiotics plus vaginal clindamycin cream for bacterial vaginosis: a randomized controlled study.,"Purpose:  To compare between continuous and interrupted use of vaginal probiotic after vaginal clindamycin cream for treatment and prevention of recurrence of bacterial vaginosis. Methods:  A double-blinded randomized controlled clinical trial, 273 women were randomly allocated to use clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed after 1 week by continuous probiotics vaginal capsule once daily for 6 weeks ( n  = 129) or clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed by one probiotic vaginal capsule twice a week for 6 weeks ( n  = 144). The initial evaluation was at 1 week after cessation of probiotics treatment to estimate the cure rates, the follow-up visits were at 1, 3, 6, and 9 months from the initial visit. The primary outcome of this study was cure rate; the secondary outcomes were the frequency of recurrence, the presence of vaginal discharge, pH > 4.5, positive whiff test and detection of clue cells. Results:  At the initial visit there was no significant difference in cure rate between continuous probiotics group and interrupted probiotics group (87.4 versus 82.5%;  p  = .81). There was no significant difference between the two groups in the recurrence rate at one, three, six and 9 months follow up visits ( p  = .16,  p  = .42,  p  = .59,  p  = .66). There was no significant difference between both groups regarding vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells at one, three, six and 9 months follow up visits. Except at 9-month visits, the differences in vaginal discharge reduction and positive whiff test were statically significant. Conclusions:  After initial treatment of bacterial vaginosis with vaginal clindamycin cream, the continuous use of vaginal probiotics is equally effective to short repetitive courses in terms of cure rates and prevention of relapse.",2021,"There was no significant difference between both groups regarding vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells at one, three, six and 9 months follow up visits.","['bacterial vaginosis', '273 women']","['vaginal clindamycin cream', 'clindamycin 2% vaginal cream 5', 'vaginal probiotic after vaginal clindamycin cream', 'vaginal probiotics plus vaginal clindamycin cream']","['frequency of recurrence, the presence of vaginal discharge, pH > 4.5, positive whiff test and detection of clue cells', 'cure rate', 'vaginal discharge reduction and positive whiff test', 'vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells', 'cure rates and prevention of relapse', 'recurrence rate']","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0975710', 'cui_str': 'clindamycin phosphate 2 % Vaginal Cream'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0227791', 'cui_str': 'Vaginal Discharge'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4039627', 'cui_str': 'Megrim'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4319573', 'cui_str': 'Clue cell'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0440421', 'cui_str': 'Droppings (substance)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",273.0,0.132063,"There was no significant difference between both groups regarding vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells at one, three, six and 9 months follow up visits.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Elsharkawy', 'Affiliation': 'Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Elsayed', 'Initials': 'E', 'LastName': 'Noureldin', 'Affiliation': 'Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ekramy', 'Initials': 'E', 'LastName': 'Mohamed', 'Affiliation': 'Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mohamed', 'Affiliation': 'Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Abdeldayem', 'Affiliation': 'Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Shymaa Abdelazim Mansour', 'Initials': 'SAM', 'LastName': 'Mansour', 'Affiliation': 'Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1588246']
710,30882160,Treatment Satisfaction with Flexible-dose Fesoterodine in Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy: A Multicenter Single-Arm Clinical Study.,"PURPOSE


We investigated treatment satisfaction with flexible-dose fesoterodine in patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy.
MATERIALS AND METHODS


The subjects were prescribed fesoterodine 4 mg for 4 weeks and fesoterodine 4 mg or 8 mg for another 8 weeks. The primary end point of this study was patients' satisfaction after 12 weeks of fesoterodine treatment on a five-point Likert scale. Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
RESULTS


Overall, 84 patients were assigned to the treatment group in this study and 63 patients completed the 12-week treatment course. A final fesoterodine dose of 4 mg and 8 mg was used by 45 (71.4%) and 18 (28.6%) patients, respectively. The satisfaction and dissatisfaction rates at 12 weeks were 69.9% and 14.2%, respectively. Mean changes in the daytime micturitions (9.73 ± 4.72 vs. 7.76 ± 2.86), urgency episodes (7.73 ± 5.68 vs. 3.71 ± 4.09), and nocturnal micturitions (2.13 ± 1.36 vs. 1.68 ± 1.12) in 24 hours improved significantly with flexible-dose fesoterodine treatment (P < .05). Most adverse events were mild and none were severe.
CONCLUSION


The flexible dose fesoterodine represents an alternative treatment modality in patients with OAB who are dissatisfied with previous anticholinergic therapy in Korea.",2020,"Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
","['patients with overactive bladder (OAB) who were dissatisfied with previous anticholinergic therapy', 'patients with OAB who are dissatisfied with previous anticholinergic therapy in Korea', '84 patients', 'Patients with Overactive Bladder who were Dissatisfied with Previous Anticholinergic Therapy']","['fesoterodine', 'Flexible-dose Fesoterodine', 'flexible-dose fesoterodine']","['change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment', 'satisfaction and dissatisfaction rates', 'urgency episodes', 'five-point Likert scale', 'nocturnal micturitions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}]",84.0,0.045367,"Secondary end points included a change in the number of daytime micturition, urgency incontinence episodes, urgency episodes, and nocturnal micturition in a 24-hour period from baseline to final assessment.
","[{'ForeName': 'Jin Bong', 'Initials': 'JB', 'LastName': 'Choi', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea. c-sparrow@hanmail.net.""}, {'ForeName': 'Kang Jun', 'Initials': 'KJ', 'LastName': 'Cho', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}, {'ForeName': 'Won Hee', 'Initials': 'WH', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Inha University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': ""Department of Urology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea.""}, {'ForeName': 'Young-Ho', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'In Rae', 'Initials': 'IR', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, Ilsanpaik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Urology, School of Medicine, Ewha Womans University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Sik', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, National Health Insurance Service, Ilsan Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': ""Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}]",Urology journal,['10.22037/uj.v0i0.4650']
711,30882163,Effects of Isothermic Irrigation on Core Body Temperature During Endoscopic Urethral Stone Treatment Surgery Under Spinal Anesthesia: A Randomized Controlled Trial.,"Purpose? Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery. The current study is designed to study the effect of isothermic hydration on core temperature in patients scheduled for endoscopic urethral stone treatment surgery under spinal anesthesia. Materials and Methods? Sixty patients allocated randomly into two groups. In GroupW (n = 30) irrigation fluid at 37°C was used whereas at room temperature in GroupRT (n = 30). Spinal anesthesia was performed at L3-L4 interspace with 15mg of hyperbaric bupivacaine. Core temperature, shivering, and hemodynamic parameters were measured every minute until 10th minute and five minute intervals until the end of operation. Shivering and surgeon comfort was also recorded. The primary outcome was the core temperature at the end of surgery. Frequencies, means, standard deviations, percentages, chi-square tests, independent samples t-test, and Mann Whitney U tests were used where eligible for the statistical analysis.Results? Baseline core temperature was 36.6 ± 0.4°C in GroupW and 36.6 ± 0.5°C in GroupRT (P = .097) which decreased to 36.0 ± 0.5°C and 35.2 ± 0.7°C respectively (P = .018) at the end of operation.  Shivering was observed in 36.7% (n = 11) in GroupRT and 6.7% (n = 2) in GroupW (P = .012). Hemodynamic parameter changes and demographic data were not significant between groups.Conclusion? Isothermic irrigation decreases both the reduction in core temperature and the incidence of shivering while increasing the surgeon comfort.",2020,Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery.,"['patients undergoing endoscopic urethral stone treatment surgery', 'Sixty patients allocated randomly into two groups', 'patients undergoing transurethral resection of prostate gland', 'patients scheduled for endoscopic urethral stone treatment surgery under spinal anesthesia']","['Isothermic irrigation', 'Spinal anesthesia was performed at L3-L4 interspace with 15mg of hyperbaric bupivacaine', 'Endoscopic Urethral Stone Treatment Surgery Under Spinal Anesthesia', 'isothermic hydration', 'Isothermic Irrigation']","['Shivering', 'core temperature at the end of surgery', 'Core Body Temperature', 'Shivering and surgeon comfort', 'Core temperature, shivering, and hemodynamic parameters', 'Hemodynamic parameter changes and demographic data', 'Frequencies, means, standard deviations, percentages, chi-square tests, independent samples t-test, and Mann Whitney U tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162301', 'cui_str': 'Calculus in urethra (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162301', 'cui_str': 'Calculus in urethra (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}]","[{'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}]",60.0,0.0455054,Isothermic irrigation decreases the reduction in core temperature and shivering in patients undergoing transurethral resection of prostate gland but this effect has not been studied in patients undergoing endoscopic urethral stone treatment surgery.,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Canturk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey. drmcanturk@gmail.com.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Hakki', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey.'}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Kocaoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ahi Evran University Training and Research Hospital, Kırsehir, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.4524']
712,30809762,Evaluating the User Performance and Experience with a Re-Engineered 4 mm × 32G Pen Needle: A Randomized Trial with Similar Length/Gauge Needles.,"INTRODUCTION


Since insulin pens were first introduced in 1985, many advances have been made in pen needles (PNs). In this study we evaluated patient-reported outcomes of an investigational newly re-engineered 4 mm × 32G PN, the BD Nano™ 2nd Gen (also known by its ""PRO"" brand extension in many markets outside of the USA). In place of a conventional cylindrical posted hub, the investigational PN's hub is contoured with an expanded surface area. The investigational PN also includes a redesigned inner shield that includes tactile ridges and a remodeled outer cover with improved proportions and attachment grips.
METHODS


This was a multi-site, prospective, open-label, two-period crossover trial. Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6 mm in length for ≥ 4 months were eligible. Subjects using     31G PNs of a similar length were eligible after a 2-week wash-in period. Subjects were assigned to one of four groups, with each group using a commercially available PN to which the investigational PN was compared. Each of the two study periods were 15 days: one with the investigational PN and the other with a comparator PN. After completing both study periods, subjects compared experiences between the two PN types. A 150-mm comparative visual analog scale (VAS) was used to evaluate overall preference (primary endpoint) and several secondary endpoints, including overall comfort, injection pain, and ease of use. Data from the four PN groups were combined after poolability was verified. Subgroup analyses were also conducted on each PN group. For VAS responses, a two-sided 95% confidence interval (CI) was calculated for average rating. Threshold for non-inferiority or superiority was established at the lower bound CI of >  - 10 mm or > 0 mm, respectively.
RESULTS


At baseline, average age of subjects was 55.6 years; 51.6% were female; and 85.1% has type 2 diabetes mellitus. Average diabetes duration was 14.2 years, and average duration of injecting was 7.8 years. The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
CONCLUSIONS


The investigational PN was rated as being overall preferred, more comfortable, less painful, and easier to use when compared to comparator PNs of similar gauge and length, in all groups combined.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov (NCT03267264).
FUNDING


BD (Becton, Dickinson, and Company).",2019,"The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
","['At baseline, average age of subjects was 55.6\xa0years; 51.6% were female; and 85.1% has type 2 diabetes mellitus', 'Individuals with type 1 and type 2 diabetes using 32G PNs of ≤ 6\xa0mm in length for\u2009≥\u20094\xa0months were eligible']","['Re-Engineered 4\xa0mm\u2009×', '32G Pen Needle', 'Similar Length/Gauge Needles']","['overall comfort, injection pain, and ease of use', 'Average diabetes duration']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.114217,"The investigational PN demonstrated superiority for all outcomes, both primary and secondary, for all groups combined (p < 0.05).
","[{'ForeName': 'Shahista', 'Initials': 'S', 'LastName': 'Whooley', 'Affiliation': 'BD (Becton, Dickinson and Company), Andover, MA\xa0, USA. shahista.whooley@bd.com.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Briskin', 'Affiliation': 'Rapid Medical Research, Cleveland, OH, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gibney', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Lydia R', 'Initials': 'LR', 'LastName': 'Blank', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Berube', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Pflug', 'Affiliation': 'BD (Becton, Dickinson and Company), Franklin Lakes, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0585-7']
713,29550184,Correlation between Surgeon's assessment and radiographic evaluation of residual disease in women with advanced stage ovarian cancer reported to have undergone optimal surgical cytoreduction: An NRG Oncology/Gynecologic Oncology Group study.,"PURPOSE


We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer.
METHODS


This is a post-trial ad hoc analysis of a phase 3 randomized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction. All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy. Information collected on trial was utilized to compare surgeon's operative assessment of RD, to pre-treatment imaging.
RESULTS


Of 1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects. Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis. The average interval from surgery to baseline scan was 26days (range: 1-109). In 251 cases (40%), the post-operative scan was discordant with surgeon assessment, demonstrating RD>1cm in size. RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%). Patients with RD>1cm on pre-treatment CT (discordant) exhibited a significantly greater risk of disease progression (HR 1.30; 95% CI 1.08-1.56; p=0.0059).
CONCLUSIONS


Among patients reported to have undergone optimal cytoreduction, 40% were found to have lesions >1cm on postoperative, pretreatment imaging. Although inflammatory changes and/or rapid tumor regrowth could account for the discordance, the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon.",2018,"RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%).","['1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects', 'patients with advanced stage ovarian cancer following surgical cytoreduction', 'Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis', 'women with advanced stage ovarian cancer', 'women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer', 'Patients with RD>1cm on']","['bevacizumab', 'residual disease (RD) and pre-treatment computed tomography (CT']","['risk of disease progression', 'retroperitoneal para-aortic lymph nodes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal Space'}, {'cui': 'C0229789', 'cui_str': 'Para-aortic node (body structure)'}]",1873.0,0.0889757,"RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%).","[{'ForeName': 'Ramez N', 'Initials': 'RN', 'LastName': 'Eskander', 'Affiliation': 'University of California, San Diego Medical Center, La Jolla, CA, United States. Electronic address: Reskander@ucsd.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauderer', 'Affiliation': 'NRG Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY, United States. Electronic address: kaudererJ@NRGOncology.org.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine Medical Center, Orange, CA, United States. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'University of Oklahoma, Oklahoma City, OK, United States. Electronic address: Robert_Mannel@ouhsc.edu.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Bristow', 'Affiliation': 'University of California, Irvine Medical Center, Orange, CA, United States. Electronic address: rbristow@uci.edu.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'Ohio State University and Wexner Medical Center, Columbus, OH, United States. Electronic address: omalley.46@osu.edu.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Rubin', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States; Chief of Gynecologic Oncology at Fox Chase Cancer Center, Philadelphia, PA. Electronic address: Stephen.rubin@fccc.edu.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Glaser', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States. Electronic address: Glaser.Gretchen@mayo.edu.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Gynecologic Cancer Center of Excellence, John P. Murtha Cancer Center, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, MD, United States. Electronic address: chad.a.hamilton2.mil@mail.mil.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Warner K', 'Initials': 'WK', 'LastName': 'Huh', 'Affiliation': 'University of Alabama Medical Center, Birmingham, AL, United States. Electronic address: whuh@uabmc.edu.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Ueland', 'Affiliation': 'University of Kentucky Medical Center, Lexington, KY, United States. Electronic address: fuela0@uky.edu.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Stephan', 'Affiliation': 'University of Iowa Hospital; Iowa City, IA, United States. Electronic address: jean-marie-stephan@uiowa.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States. Electronic address: burgerr@uphs.upenn.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2018.03.043']
714,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
715,27756884,Early2 factor (E2F) deregulation is a prognostic and predictive biomarker in lung adenocarcinoma.,"Clinicians routinely prescribe adjuvant chemotherapy (ACT) for resected non-small cell lung cancer patients. However, ACT only improves five-year disease-free survival in stage I-III non-small cell lung cancer by 5-15%, with most patients deriving no benefit. Herein, deregulation of the E2F pathway was explored as a biomarker in lung adenocarcinoma patients. An E2F pathway scoring system, based on 74 E2F-regulated genes, was trained for RNA from two platforms: fresh-frozen (FF) or formalin-fixed paraffin-embedded (FFPE) tissues. The E2F score was tested as a prognostic biomarker in five FF-based cohorts and two FFPE-based cohorts. The E2F score was tested as a predictive biomarker in two randomized clinical trials; JBR10 and the NATCH (Neo-Adjuvant Taxol-Carboplatin Hope) trial. The E2F score was prognostic in untreated patients in all seven datasets examined (p < 0.05). Stage-specific analysis of combined cohorts demonstrated that the E2F score was prognostic in stage I patients (p = 0.0495 to <0.001; hazard ratio, HR, =2.04- 2.22) with a similar trend in other stages. The E2F score was strongly predictive in stage II patients from the two combined randomized clinical trials with a significant differential treatment effect (p = 0.015). Specifically, ACT improved survival in stage II patients with high E2F (p = 0.01; HR= 0.21). The 5-year survival increased from 18% to 81%. In contrast, in patients with low E2F, 5-year survival was 57% in untreated patients and 41% in ACT-treated patients with a HR of 1.55 (p = 0.47). In summary, the E2F score provides valuable prognostic information for Stage I and predictive information for Stage II lung adenocarcinoma patients and should be further explored as a decision support tool for their treatment.",2016,"However, ACT only improves five-year disease-free survival in stage I-III non-small cell lung cancer by 5-15%, with most patients deriving no benefit.","['small cell lung cancer patients', 'lung adenocarcinoma', 'Stage II lung adenocarcinoma patients', 'lung adenocarcinoma patients']","['adjuvant chemotherapy (ACT', 'ACT', 'NATCH']","['E2F score', '5-year survival', 'survival']","[{'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.149462,"However, ACT only improves five-year disease-free survival in stage I-III non-small cell lung cancer by 5-15%, with most patients deriving no benefit.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Kurtyka', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Welsh', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Rivera', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Brienne E', 'Initials': 'BE', 'LastName': 'Engel', 'Affiliation': 'Cancer Biology and Evolution, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Teresita', 'Initials': 'T', 'LastName': 'Muñoz-Antonia', 'Affiliation': 'Tumor Biology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Yoder', 'Affiliation': 'Molecular Genomics Core Facility, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Eschrich', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Ben C', 'Initials': 'BC', 'LastName': 'Creelan', 'Affiliation': 'Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Alberto A', 'Initials': 'AA', 'LastName': 'Chiappori', 'Affiliation': 'Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Ramirez', 'Affiliation': 'Cancer Biology & Precision Medicine Program, Catalan Institute of Oncology, Badalona, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Cancer Biology & Precision Medicine Program, Catalan Institute of Oncology, Badalona, Barcelona, Spain.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Schabath', 'Affiliation': 'Cancer Epidemiology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Haura', 'Affiliation': 'Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'Dung-Tsa', 'Initials': 'DT', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Cress', 'Affiliation': 'Cancer Biology and Evolution, H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA.'}]",Oncotarget,['10.18632/oncotarget.12672']
716,29488628,Effect of prenatal mindfulness training on depressive symptom severity through 18-months postpartum: A latent profile analysis.,"OBJECTIVE


We examined whether prenatal mindfulness training was associated with lower depressive symptoms through 18-months postpartum compared to treatment as usual (TAU).
METHOD


A controlled, quasi-experimental trial compared prenatal mindfulness training (MMT) to TAU. We collected depressive symptom data at post-intervention, 6-, and 18-months postpartum. Latent profile analysis identified depressive symptom profiles, and multinomial logistic regression examined whether treatment condition predicted profile.
RESULTS


Three depressive symptom severity profiles emerged: none/minimal, mild, and moderate. Adjusting for relevant covariates, MMT participants were less likely than TAU participants to be in the moderate profile than the none/minimal profile (OR = 0.13, 95% CI = 0.03-0.54, p = .005).
CONCLUSIONS


Prenatal mindfulness training may have benefits for depressive symptoms during the transition to parenthood.",2018,"OBJECTIVE


We examined whether prenatal mindfulness training was associated with lower depressive symptoms through 18-months postpartum compared to treatment as usual (TAU).
",['through 18-months postpartum'],"['Prenatal mindfulness training', 'prenatal mindfulness training (MMT) to TAU', 'prenatal mindfulness training']","['depressive symptoms', 'depressive symptom severity']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0317104,"OBJECTIVE


We examined whether prenatal mindfulness training was associated with lower depressive symptoms through 18-months postpartum compared to treatment as usual (TAU).
","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Felder', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Roubinov', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Bush', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Coleman-Phox', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, San Francisco.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Vieten', 'Affiliation': 'Institute of Noetic Sciences and California Pacific Medical Center Research Institute.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Laraia', 'Affiliation': 'Community Health Sciences, University of California, Berkeley.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}]",Journal of clinical psychology,['10.1002/jclp.22592']
717,31708151,"Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.
METHODS


We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626.
FINDINGS


Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
INTERPRETATION


The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia.
FUNDING


WHO, India.",2019,"None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
","['958 women in the', 'pregnant women with moderate-to-severe anaemia in India', 'women with moderate-to-severe iron deficiency anaemia in pregnancy', '961 women in the', '737 women in the', 'Between Jan 31, 2014, and July 31, 2017, 2018', 'four government medical colleges in India', 'Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL', 'pregnant women with moderate-to-severe anaemia']","['intravenous iron sucrose versus standard oral iron therapy', 'intravenous iron sucrose', 'standard oral iron therapy', 'intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy', 'intravenous iron sucrose (intervention) versus standard oral iron (control) therapy']","['Safety', 'modified intention-to-treat population', 'serious maternal adverse events', 'potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia', 'Serious fetal and neonatal adverse events', 'safety and clinical effectiveness', 'Safety and effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0060241', 'cui_str': 'iron saccharate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1444752', 'cui_str': 'Status during (qualifier value)'}, {'cui': 'C2936491', 'cui_str': 'Peripartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0269936', 'cui_str': 'Postpartum Sepsis'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0195620', 'cui_str': 'Low cervical cesarean section (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",982.0,0.316237,"None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body.
","[{'ForeName': 'Sutapa B', 'Initials': 'SB', 'LastName': 'Neogi', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India. Electronic address: sutapa.bneogi@iiphd.org.'}, {'ForeName': 'Niveditha', 'Initials': 'N', 'LastName': 'Devasenapathy', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Bhushan', 'Affiliation': 'National Health Systems Resource Centre, New Delhi, India.'}, {'ForeName': 'Duru', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Breach Candy Hospital, Mumbai, India; Indian College of Obstetricians and Gynaecologists, Federation of Obstetrics and Gynaecology Society of India, Mumbai, India.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Divakar', 'Affiliation': ""Divakar's Speciality Hospital, Bangalore, India.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Zodpey', 'Affiliation': 'Indian Institute of Public Health-Delhi, Public Health Foundation of India, Gurgaon, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Smiti', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Achla', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Meenakshi B', 'Initials': 'MB', 'LastName': 'Chauhan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Dongre', 'Affiliation': 'Department of Obstetrics and Gynaecology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Saluja', 'Affiliation': 'Department of Hematology, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Vani', 'Initials': 'V', 'LastName': 'Malhotra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Sangwan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Pt Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, India.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Radhika', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Bhaskaran', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Mrinalini', 'Initials': 'M', 'LastName': 'Kotru', 'Affiliation': 'Department of Pathology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Sikka', 'Affiliation': 'Department of Pathology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Guru Teg Bahadur Hospital, New Delhi, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Francis', 'Affiliation': 'WHO, New Delhi, India.'}, {'ForeName': 'Kasonde', 'Initials': 'K', 'LastName': 'Mwinga', 'Affiliation': 'WHO, Kigali, Rwanda.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Baswal', 'Affiliation': 'Ministry of Health and Family Welfare, Government of India, New Delhi, India.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30427-9']
718,31704126,The effects of early pacifier use on breastfeeding: A randomised controlled trial.,"BACKGROUND


The majority of observational studies have found associations between pacifier use and shorter breastfeeding duration. Results from four randomised controlled trials did not reveal any difference in breastfeeding outcomes. The relationship between early pacifier use and breastfeeding outcomes remains unclear.
AIM


To investigate whether a recommendation of early pacifier use affects the proportion of breastfeeding at six months compared to a recommendation to avoid pacifier use during the first two weeks.
METHODS


An open, randomised controlled trial with parallel group design; 239 primiparous mothers and their term infants were randomly assigned to an intervention group or a control group. The primary outcome was the proportion of breastfeeding at six months. Secondary outcomes were the proportions of breastfeeding and breastfeeding problems at two and four months. To investigate factors which may influence breastfeeding, a multivariate logistic regressions analysis was performed.
FINDINGS


A total of 209 participants (87.5%) completed the study. There were no significant differences between the groups with respect to breastfeeding at six months. No negative association for breastfeeding between early versus late introduction of pacifier was found. Factors significantly associated with cessation of breastfeeding at six months were: use of nipple shield, intention to breastfeed, severe breastfeeding problems at two weeks, pacifier use at two months and lower educational level.
CONCLUSION


Early versus late recommendation of pacifier introduction did not affect the proportion of breastfeeding at six months. However, the compliance to the randomised group was insufficient. No negative association was found in the observational analysis.",2020,There were no significant differences between the groups with respect to breastfeeding at six months.,"['A total of 209 participants (87.5%) completed the study', '239 primiparous mothers and their term infants']",[],"['proportions of breastfeeding and breastfeeding problems', 'proportion of breastfeeding at six months', 'nipple shield, intention to breastfeed, severe breastfeeding problems', 'breastfeeding outcomes', 'breastfeeding', 'proportion of breastfeeding']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]",[],"[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0183252', 'cui_str': 'Nipple shield (physical object)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",209.0,0.117795,There were no significant differences between the groups with respect to breastfeeding at six months.,"[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Hermanson', 'Affiliation': 'Department of Obstetrics, and Gynaecology, University Hospital, Linköping, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden. Electronic address: asa.hermansson@regionostergotland.se.'}, {'ForeName': 'Lotta Lindh', 'Initials': 'LL', 'LastName': 'Åstrand', 'Affiliation': 'Department of Obstetrics, and Gynaecology, Linköping University, Linköping, Sweden; Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2019.10.001']
719,29632895,The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD.,"Posttraumatic stress disorder (PTSD) affects up to 30% of military veterans. Older veterans, many of whom have lived with PTSD symptoms for several decades, report a number of negative health outcomes. Despite the demonstrated benefits of regular exercise on physical and psychological health, no studies have explored the impact of exercise in older veterans with PTSD. This paper describes the development, design, and implementation of the Warrior Wellness exercise pilot study for older veterans with PTSD. Veterans aged ≥60 with a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of PTSD will be recruited and randomized to (a) Warrior Wellness, a 12-week supervised, facility-based exercise intervention, or (b) usual care for 12 weeks. Warrior Wellness is a theory- and evidence-based behavioral intervention that involves 3 sessions per week of multi-component exercise training that targets strength, endurance, balance, and flexibility. Warrior Wellness focuses on satisfaction with outcomes, self-efficacy, self-monitoring, and autonomy. Factors associated with program adherence, defined as the number of sessions attended during the 12 weeks, will be explored. Primary outcomes include PTSD symptoms and cardiovascular endurance, assessed at baseline and 12 weeks. Compared to those in usual care, it is hypothesized that those in the Warrior Wellness condition will improve on these efficacy outcomes. The Warrior Wellness study will provide evidence on whether a short-term exercise intervention is feasible, acceptable, and effective among older veterans with PTSD, and explore factors associated with program adherence. ClinicalTrials.gov  Identifier : NCT02295995.",2018,"Compared to those in usual care, it is hypothesized that those in the Warrior Wellness condition will improve on these efficacy outcomes.","['Older veterans', 'Posttraumatic stress disorder (PTSD) affects up to 30% of military veterans', 'older veterans with PTSD', 'Older Veterans with PTSD', 'Veterans aged ≥60 with']","['short-term exercise intervention', 'regular exercise']","['PTSD symptoms and cardiovascular endurance', 'satisfaction with outcomes, self-efficacy, self-monitoring, and autonomy']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]",,0.0137647,"Compared to those in usual care, it is hypothesized that those in the Warrior Wellness condition will improve on these efficacy outcomes.","[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Hall', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, Durham, NC.'}, {'ForeName': 'Miriam C', 'Initials': 'MC', 'LastName': 'Morey', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, Durham, NC.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Beckham', 'Affiliation': 'VA Durham Healthcare System, Mental Illness Research, Education, and Clinical Center, Durham, NC.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Duke University, Department of Psychiatry and Behavioral Sciences, Durham, NC.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Pebole', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, Durham, NC.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke University, Department of Biostatistics and Bioinformatics, Durham, NC.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'VA Durham Healthcare System, Geriatric Research, Education, and Clinical Center, Durham, NC.'}]",Translational journal of the American College of Sports Medicine,['10.1249/TJX.0000000000000056']
720,29879680,Impact of e-liquid flavors on e-cigarette vaping behavior.,"OBJECTIVE


The primary objective of this pilot study was to describe the impact of e-cigarette liquid flavors on experienced e-cigarette users' vaping behavior.
METHODS


11 males and 3 females participated in a 3-day inpatient crossover study using e-cigarettes with strawberry, tobacco, and their usual brand e-liquid. Nicotine levels were nominally 18 mg/mL in the strawberry and tobacco e-liquids and ranged between 3-18 mg/mL in the usual brands. On each day, participants had access to the study e-cigarette (KangerTech mini ProTank 3, 1.5 Ohms, 3.7 V) and the assigned e-liquid during a 90-minute videotaped ad libitum session.
RESULTS


Average puff duration was significantly longer when using the strawberry e-liquid (3.2 ± 1.3 s, mean ± SD) compared to the tobacco e-liquid (2.8 ± 1.1 s) but the average number of puffs was not significantly different (strawberry, 73 ± 35; tobacco, 69 ± 46). Compared to the strawberry- and tobacco-flavored e-liquids, average puff duration was significantly longer (4.3 ± 1.6 s) and the average number of puffs was significantly higher (106 ± 67 puffs) when participants used their usual brand of e-liquid. Participants generally puffed more frequently in small groups of puffs (1-5 puffs) with the strawberry compared to the tobacco e-liquid and more frequently in larger groups (>10 puffs) with their usual brand. The strength of the relationship between vaping topography and nicotine intake and exposure were not consistent across e-liquids.
CONCLUSION


Vaping behavior changes across e-liquids and influences nicotine intake. Research is needed to understand the mechanisms that underlie these behavioral changes, including e-liquid pH and related sensory effects, subjective liking, and nicotine effects.",2018,Participants generally puffed more frequently in small groups of puffs (1-5 puffs) with the strawberry compared to the tobacco e-liquid and more frequently in larger groups (>10 puffs) with their usual brand.,"['11 males and 3 females participated in a 3-day inpatient crossover study using e-cigarettes with strawberry, tobacco, and their usual brand e-liquid']",['e-liquid flavors'],"['Nicotine levels', 'Average puff duration', 'average number of puffs']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0457802', 'cui_str': 'Strawberries'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}]","[{'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",11.0,0.0268146,Participants generally puffed more frequently in small groups of puffs (1-5 puffs) with the strawberry compared to the tobacco e-liquid and more frequently in larger groups (>10 puffs) with their usual brand.,"[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine, University of California, San Francisco, CA, United States; Center for Tobacco Control Research and Education, University of California, San Francisco, CA, United States; UCSF Tobacco Center of Regulatory Science (TCORS), United States. Electronic address: Gideon.Sthelen@ucsf.edu.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Shahid', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Sherman', 'Initials': 'S', 'LastName': 'Chu', 'Affiliation': 'Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine, University of California, San Francisco, CA, United States; Center for Tobacco Control Research and Education, University of California, San Francisco, CA, United States; UCSF Tobacco Center of Regulatory Science (TCORS), United States; Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.04.032']
721,31605792,Programmed Cell Death Ligand 1 Expression in Untreated EGFR Mutated Advanced NSCLC and Response to Osimertinib Versus Comparator in FLAURA.,"INTRODUCTION


EGFR mutated (EGFRm) NSCLC tumors occasionally express programmed cell death ligand 1 (PD-L1), although frequency and clinical relevance are not fully characterized. We report PD-L1 expression in patients with EGFRm advanced NSCLC and association with clinical outcomes following treatment with osimertinib or comparator EGFR tyrosine kinase inhibitors in the FLAURA trial (phase III, NCT02296125).
METHODS


Of 231 tissue blocks available from the screened population (including EGFRm-positive and -negative samples), 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana, Tucson, Arizona) immunohistochemical assay. Tumor cell (TC) staining thresholds of PD-L1 TC greater than or equal to 1%, TC greater than or equal to 25%, and TC greater than or equal to 50% were applied. Progression-free survival (PFS) was investigator-assessed, per Response Evaluation Criteria in Solid Tumor, version 1.1, according to PD-L1 expressors (TC ≥ 1%) or negatives (TC < 1%) in randomized patients.
RESULTS


PD-L1 staining was successful in 193 of 197 patient formalin-fixed paraffin-embedded blocks; of these, 128 of 193 were EGFRm-positive and 106 of 128 patients were randomized to treatment (osimertinib: 54; comparator: 52). At the PD-L1 TC greater than or equal to 25% threshold, 8% (10 of 128) of EGFRm-positive tumors expressed PD-L1 versus 35% (23 of 65) of EGFRm-negative tumors. With the TC greater than or equal to 1% threshold, 51% (65 of 128) versus 68% (44 of 65) were mutation-positive and -negative, respectively, and with the TC greater than or equal to 50% threshold, 5% (7 of 128) versus 28% (18 of 65), were mutation-positive and -negative, respectively. For PD-L1 expressors (TC ≥ 1%), median PFS was 18.4 months with osimertinib and 6.9 months with comparator (hazard ratio = 0.30; 95% confidence interval: 0.15-0.60). For PD-L1-negative patients (TC < 1%), median PFS was 18.9 months with osimertinib and 10.9 months with comparator (hazard ratio = 0.37; 95% confidence interval: 0.17-0.74).
CONCLUSIONS


Clinical benefit with osimertinib was unaffected by PD-L1 expression status.",2020,", 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana) immunohistochemical assay.","['Of 231 tissue blocks available from the screened population (including EGFRm positive and negative samples', 'patients with EGFRm advanced NSCLC']",['Epidermal growth factor receptor mutated (EGFRm'],"['median PFS', 'Progression-free survival (PFS']","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",231.0,0.0437835,", 197 had sufficient tissue for PD-L1 testing using the SP263 (Ventana) immunohistochemical assay.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vansteenkiste', 'Affiliation': 'Respiratory Oncology Unit (Respiratory Diseases), University Hospital KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Medical Oncology Department, University Regional Hospital of Málaga, IBIMA, Málaga, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Barker', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Todd', 'Affiliation': 'Oncology Biometrics, Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Saggese', 'Affiliation': 'Global Medicines Development, Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Juliann', 'Initials': 'J', 'LastName': 'Chmielecki', 'Affiliation': 'Translational Medicine, Oncology, AstraZeneca, Waltham, Massachusetts.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Markovets', 'Affiliation': 'Translational Medicine, Oncology, AstraZeneca, Waltham, Massachusetts.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Emory University School of Medicine, Winship Cancer Institute, Atlanta, Georgia. Electronic address: suresh.ramalingam@emory.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.009']
722,31733088,"Ketamine for acute suicidal ideation. An emergency department intervention: A randomized, double-blind, placebo-controlled, proof-of-concept trial.","BACKGROUND


Depressed patients presenting to emergency departments with acute suicidal ideation are a major public health concern. Ketamine, a rapidly acting antidepressant with antisuicidal properties, might offer relief.
METHODS


In a randomized, double-blind, placebo-controlled, proof-of-concept trial, 18 depressed subjects with acute suicidal ideation, who required hospitalization, were randomized to either an intravenous ketamine 0.2 mg/kg group or a saline placebo group. Safety and efficacy evaluations were scheduled for 15, 30, 60, 90, 120, 180, and 240 min, and on Days 1, 2, 3, 7, and 14 after infusion. The main outcome measure was suicidal ideation with secondary measures of depression.
RESULTS


Nine subjects were randomized to each group. There were no differences between groups at baseline in any demographic or assessment scales. A reduction in suicidal ideation was noted at 90-180 min (p < .05). Ninety minutes after infusion, 88% of the ketamine group had achieved remission of suicidal ideation compared with 33% in the placebo group (p < .05). No serious adverse events were noted.
CONCLUSIONS


Ketamine was safe and effective for rapid reduction in suicidal ideation in depressed, highly suicidal subjects presenting to the emergency department. Our results support further study of ketamine for acute suicidal ideation.",2020,"CONCLUSIONS


Ketamine was safe and effective for rapid reduction in suicidal ideation in depressed, highly suicidal subjects presenting to the emergency department.","['Nine subjects', '18 depressed subjects with acute suicidal ideation, who required hospitalization', 'Depressed patients presenting to emergency departments with acute suicidal ideation', 'acute suicidal ideation']","['placebo', 'Ketamine', 'ketamine', 'intravenous ketamine 0.2\u2009mg/kg group or a saline placebo']","['suicidal ideation with secondary measures of depression', 'Safety and efficacy evaluations', 'acute suicidal ideation', 'suicidal ideation', 'serious adverse events', 'remission of suicidal ideation']","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",9.0,0.524909,"CONCLUSIONS


Ketamine was safe and effective for rapid reduction in suicidal ideation in depressed, highly suicidal subjects presenting to the emergency department.","[{'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Domany', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Cheryl B', 'Initials': 'CB', 'LastName': 'McCullumsmith', 'Affiliation': 'Department of Psychiatry, College of Medicine and Life Sciences, University of Toledo, Toledo, Ohio.'}]",Depression and anxiety,['10.1002/da.22975']
723,30706365,Efficacy of Real-Time Continuous Glucose Monitoring to Improve Effects of a Prescriptive Lifestyle Intervention in Type 2 Diabetes: A Pilot Study.,"INTRODUCTION


Optimising patient adherence to prescribed lifestyle interventions to achieve improved blood glucose control remains a challenge. Combined use of real-time continuous glucose monitoring systems (RT-CGM) may promote improved glycaemic control. This pilot study examines the effects of a prescriptive lifestyle modification programme when combined with RT-CGM on blood glucose control and cardiovascular disease risk markers.
METHODS


Twenty adults (10 men, 10 women) with obesity and type-2 diabetes (T2D) (age 60.55 ± 8.38 years, BMI 34.22 ± 4.67 kg/m 2 ) were randomised to a prescriptive low-carbohydrate diet and lifestyle plan whilst continuously wearing either an RT-CGM or an 'offline-blinded' monitor (control) for 12 weeks. Outcomes were glycaemic control (HbA1c, fasting glucose, glycaemic variability [GV]), diabetes medication (MeS), weight, blood pressure and lipids assessed pre- and post-intervention.
RESULTS


Both groups experienced reductions in body weight (RT-CGM - 7.4 ± 4.5 kg vs. control - 5.5 ± 4.0 kg), HbA1c (- 0.67 ± 0.82% vs. - 0.68 ± 0.74%), fasting blood glucose (- 1.2 ± 1.9 mmol/L vs. - 1.0 ± 2.2 mmol/L), LDL-C (- 0.07 ± 0.34 mmol/L vs. - 0.26 ± 0.42 mmol/L) and triglycerides (- 0.32 ± 0.46 mmol/L vs. - 0.36 ± 0.53 mmol/L); with no differential effect between groups (P ≥ 0.10). At week 12, GV indices were consistently lower by at least sixfold in RT-CGM compared to control (CONGA-1 - 0.27 ± 0.36 mmol/L vs. 0.06 ± 0.19 mmol/L; CONGA-2 - 0.36 ± 0.54 mmol/L vs. 0.05 ± 2.88 mmol/L; CONGA-4 - 0.44 ± 0.67 mmol/L vs. - 0.02 ± 0.42 mmol/L; CONGA-8 - 0.36 ± 0.61 vs. 0.02 ± 0.52 mmol/L; MAGE - 0.69 ± 1.14 vs. - 0.09 ± 0.08 mmol/L, although there was insufficient power to achieve statistical significance (P ≥ 0.11). Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).
CONCLUSION


This study provides preliminary evidence that RT-CGM may be an effective strategy to optimise glucose control whilst following a low-carbohydrate lifestyle programme that targets improved glycaemic control, with minimal professional support.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry identifier, ANZTR: 372898.
FUNDING


Grant funding was received for the delivery of the clinical trial only, by the Diabetes Australia Research Trust (DART).",2019,"Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).
","['Twenty adults (10 men, 10 women) with obesity and type-2 diabetes (T2D) (age 60.55 ± 8.38 years, BMI 34.22 ± 4.67\xa0kg/m 2 ', 'Type 2 Diabetes']","['real-time continuous glucose monitoring systems (RT-CGM', 'prescriptive lifestyle modification programme', 'Real-Time Continuous Glucose Monitoring', ""prescriptive low-carbohydrate diet and lifestyle plan whilst continuously wearing either an RT-CGM or an 'offline-blinded' monitor (control"", 'RT-CGM', 'Prescriptive Lifestyle Intervention']","['blood glucose control and cardiovascular disease risk markers', 'glycaemic control (HbA1c, fasting glucose, glycaemic variability [GV]), diabetes medication (MeS), weight, blood pressure and lipids assessed pre- and post-intervention', 'glycaemic control', 'fasting blood glucose', 'blood glucose-lowering medication (MeS', 'body weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",20.0,0.0203725,"Overall, there was an approximately 40% greater reduction in blood glucose-lowering medication (MeS) in RT-CGM (- 0.30 ± 0.59) compared to control (0.02 ± 0.23).
","[{'ForeName': 'Penelope J', 'Initials': 'PJ', 'LastName': 'Taylor', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation, Health and Biosecurity, Adelaide, Australia. Pennie.Taylor@csiro.au.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation, Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Wycherley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, School of Health Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation, Health and Biosecurity, Sydney, Australia.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0572-z']
724,31694851,The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia.,"INTRODUCTION


Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on 'trial and error'. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking.
METHODS AND ANALYSIS


In an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018-2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours; followed by continuous infusion of 1.6 mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) <0.05 is considered significant in all analyses.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the ethics committee in Rotterdam (MEC-2017-324) and the central Committee on Research Involving Human Subjects (NL60229.078.17) in the Netherlands. The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. Parental informed consent will be obtained.
TRIAL REGISTRATION NUMBER


NTR6982; Pre-results.",2019,"We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed.","['Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018-2022', 'newborns with PH without CDH', 'pulmonary hypertension in neonates with congenital diaphragmatic hernia']","['Congenital diaphragmatic hernia (CDH', 'sildenafil', 'Intravenous sildenafil', 'sildenafil or iNO', 'Sildenafil', 'nitric oxide', 'Inhaled nitric oxide (iNO']","['mortality', 'clinical and echocardiographic markers of PH in the first year of life', 'absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life']","[{'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0235833', 'cui_str': 'Congenital Diaphragmatic Defect'}]","[{'cui': 'C0235833', 'cui_str': 'Congenital Diaphragmatic Defect'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",330.0,0.278438,"We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed.","[{'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Cochius-den Otter', 'Affiliation': 'Department of Intensive care and Pediatric Surgery, Erasmus University Rotterdam, Rotterdam, The Netherlands s.denotter@erasmusmc.nl.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schaible', 'Affiliation': 'Department of Neonatology, University Medical Center, Mannheim, Mannheim, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'van Heijst', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Neonatology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Allegaert', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Department of Biostatistics, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': 'Department of Intensive care and Pediatric Surgery, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032122']
725,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
726,31697010,Fractional CO 2  laser plus topical antifungal versus fractional CO 2  laser versus topical antifungal in the treatment of onychomycosis.,"Onychomycosis is an important medical disorder affecting both health and quality of life of patients. This study was done to compare the efficacy of CO 2  laser in combination with topical tioconazole versus CO 2  laser only versus topical tioconazole alone in onychomycosis. A total of 120 patients with onychomycosis were randomly assigned to three groups. Group A patients were treated with fractional CO 2  laser followed by topical tioconazole 28% for five sessions with 3 weeks interval. Group B patients were treated with only fractional CO 2  laser for five sessions with 3 weeks interval. Group C patients were treated with only topical tioconazole 28% for 16 weeks. The clinical effect, KOH examination, and culture for the affected nails in the three groups were analyzed. One month after the last session, regarding clinical response, 55% showed complete clinical improvement in Group A versus 30% in Group B versus 25% in Group C with a significant difference in between. There was a significant difference between the three studied groups as regard KOH test and culture after treatment. Fractional CO 2  laser combined with topical antifungal is a safe and effective treatment for onychomycosis.",2020,"There was a significant difference between the three studied groups as regard KOH test and culture after treatment.
","['120 patients with onychomycosis', 'onychomycosis']","['CO2 laser', 'topical tioconazole', 'topical tioconazole versus CO2 laser', 'Fractional CO2 laser plus topical antifungal versus fractional CO2 laser', 'Fractional CO2 laser combined with topical antifungal', 'only fractional CO2 laser', 'fractional CO2 laser followed by topical tioconazole']","['regard KOH test and culture', 'complete clinical improvement']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}]","[{'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0076705', 'cui_str': 'tioconazole'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4552580', 'cui_str': 'Antifungal (disposition)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",120.0,0.0197386,"There was a significant difference between the three studied groups as regard KOH test and culture after treatment.
","[{'ForeName': 'Amr Mohamed', 'Initials': 'AM', 'LastName': 'Zaki', 'Affiliation': 'Dermatology and Venereology Department, Al-Azhar Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Hamed Mohamed', 'Initials': 'HM', 'LastName': 'Abdo', 'Affiliation': 'Dermatology and Venereology Department, Al-Azhar Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Mohamed Anwer', 'Initials': 'MA', 'LastName': 'Ebadah', 'Affiliation': 'Dermatology and Venereology Department, Al-Azhar Faculty of Medicine, Cairo, Egypt.'}, {'ForeName': 'Shady Mahmoud', 'Initials': 'SM', 'LastName': 'Ibrahim', 'Affiliation': 'Dermatology and Venereology Department, Al-Azhar Faculty of Medicine, Cairo, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13155']
727,30720382,Role of technology in improving knowledge and confidence in asthma management in school staff.,"Objective:  To investigate the effectiveness of technology enabled learning in improving asthma first aid knowledge and self-confidence in providing asthma first aid to children in staff within a school setting.  Study Design:  A prospective randomized parallel study using a pre and post test design was conducted across Metropolitan schools of New South Wales (NSW), Australia. School staff in selected schools were randomly assigned to receive first aid asthma management training via a self-directed multimedia eBook learning resource or standard face-to-face training. Staff completed a 14 item validated Asthma First Aid Knowledge Questionnaire and a 4 item, 10-point Likert-scale asthma management self-confidence questionnaire immediately pre and post training.  Results:  148 school staff from 46 schools were recruited with a total of 59 (78%) staff completing the eBook training and 62 (86%) completing face-to-face training. The mean asthma first aid knowledge score and self-confidence score in managing asthma increased significantly ( p  < 0.0001) in the eBook training group post training. There was no significant difference in the increase in the mean scores post training between the eBook and face-to-face training groups ( p  = 0.11).  Conclusion:  Asthma management knowledge and self-confidence increased in school staff following the eBook training. In school settings where human resources for health education are limited, technology enabled learning may be substituted to provide a self-directed approach to asthma first aid management training.",2020,The mean asthma first aid knowledge score and self-confidence score in managing asthma increased significantly (p < 0.0001) in the eBook training group post training.,"['asthma management in school staff', 'School staff in selected schools', 'children in staff within a school setting', '148 school staff from 46 schools were recruited with a total of 59 (78%) staff completing the eBook training and 62 (86%) completing face-to-face training', 'Metropolitan schools of New South Wales (NSW), Australia']","['technology enabled learning', 'asthma management training via a self-directed multimedia eBook learning resource or standard face-to-face training']","['mean asthma first aid knowledge score and self-confidence score in managing asthma', 'Asthma First Aid Knowledge Questionnaire and a 4 item, 10-point Likert-scale asthma management self-confidence questionnaire immediately pre and post training']","[{'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0016143', 'cui_str': 'First Aid'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",,0.0107133,The mean asthma first aid knowledge score and self-confidence score in managing asthma increased significantly (p < 0.0001) in the eBook training group post training.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Francis', 'Affiliation': ""Respiratory Department, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gray', 'Affiliation': ""Respiratory Department, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Burns', 'Affiliation': ""Respiratory Department, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Briggs', 'Affiliation': 'Stats Central, Mark Wainwright Analytical Centre, UNSW Sydney, Australia.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Homaira', 'Affiliation': ""Respiratory Department, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Jaffe', 'Affiliation': ""Respiratory Department, Sydney Children's Hospital, Sydney, Australia.""}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2019.1571087']
728,30094390,An analysis of adaptations to multi-level intervention strategies to enhance implementation of clinical practice guidelines for treating tobacco use in dental care settings.,"Introduction


Our team conducted a cluster randomized controlled trial (DUET) that compared the effectiveness of three theory-driven, implementation strategies on dental provider adherence to tobacco dependence treatment guidelines (TDT). In this paper we describe the process of adapting the implementation strategies to the local context of participating dental public health clinics in New York City.
Methods


Eighteen dental clinics were randomized to one of three study arms testing several implementation strategies: Current Best Practices (CBP) (i.e. staff training, clinical reminder system and Quitline referral system); CBP + Performance Feedback (PF) (i.e. feedback reports on provider delivery of TDT); and CBP + PF + Pay-for-Performance (i.e. financial incentives for provision of TDT). Through an iterative process, we used Stirman's modification framework to classify, code and analyze modifications made to the implementation strategies.
Results


We identified examples of six of Stirman's twelve content modification categories and two of the four context modification categories. Content modifications were classified as: tailoring, tweaking or refining (49.8%), adding elements (14.1%), departing from the intervention (9.3%), loosening structure (4.4%), lengthening and extending (4.4%) and substituting elements (4.4%). Context modifications were classified as those related to personnel (7.9%) and to the format/channel (8.8%) of the intervention delivery. Common factors associated with adaptations that arose during the intervention included staff changes, time constraints, changes in leadership preferences and functional limitations of to the Electronic Dental Record.
Conclusions


This study offers guidance on how to capture intervention adaptation in the context of a multi-level intervention aimed at implementing sustainable changes to optimize TDT in varying public health dental settings.",2018,"Common factors associated with adaptations that arose during the intervention included staff changes, time constraints, changes in leadership preferences and functional limitations of to the Electronic Dental Record.
","['varying public health dental settings', 'participating dental public health clinics in New York City', 'Methods\n\n\nEighteen dental clinics']","['several implementation strategies: Current Best Practices (CBP) (i.e. staff training, clinical reminder system and Quitline referral system); CBP\xa0+\xa0Performance Feedback (PF) (i.e. feedback reports on provider delivery of TDT); and CBP\xa0+\xa0PF\xa0+\xa0Pay-for-Performance (i.e. financial incentives for provision of TDT']",['loosening structure'],"[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0011344', 'cui_str': 'Dental Clinics'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085519', 'cui_str': 'Reminder Systems'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0301039', 'cui_str': '1-Chloro-3-bromopropene-1 (substance)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2713472', 'cui_str': 'Pay for Performance'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}]",18.0,0.0395494,"Common factors associated with adaptations that arose during the intervention included staff changes, time constraints, changes in leadership preferences and functional limitations of to the Electronic Dental Record.
","[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, New York University School of Medicine, 180 Madison Ave, New York, NY, 10016, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kyriakos', 'Affiliation': 'European Network for Smoking and Tobacco Prevention, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Campo', 'Affiliation': 'New York University Rory Meyers College of Nursing, 433 1st Ave, 4th Fl, New York, NY, 10003, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences and the Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Khalife', 'Affiliation': 'Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ostroff', 'Affiliation': 'Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2018.07.003']
729,30714752,"Brief behavioral activation intervention for depressive symptoms: Patient satisfaction, acceptability, engagement, and treatment response.","Depressive symptoms are the most common reason for referral to integrated behavioral health providers in primary care. Although evidence-based brief psychotherapies for depression in primary care exist, treatment duration is a significant barrier to implementation. In this open trial, we examined the patient experience of receiving a brief behavioral activation intervention designed for use in primary care (BA-PC), which comprised 2 30-min appointments and 2 boosters spaced 2-3 weeks apart across 12 weeks, and its impact on depression symptoms. Participants were 22 patients recruited from primary care who reported at least moderate depressive symptoms (score ≥ 10 on the Patient Health Questionnaire-9 [PHQ-9]). Patient experiences were examined through assessing patient engagement, satisfaction, acceptability, and treatment response. Fidelity of intervention delivery in delivering the BA-PC within a 12-week period was also assessed. Participants reported a high level of satisfaction with and acceptability of the BA-PC intervention, materials, and format. Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score,  t (21) = 3.80,  p  = .001. Evidence of fidelity included 81% of patients completing the 2 BA-PC appointments, average appointment lengths of approximately 30 min, and high content fidelity within each appointment. These preliminary findings suggest that overall experience of a brief BA-PC intervention was positive, with high patient satisfaction, patient acceptability, and treatment fidelity as well as positive patient treatment response. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score,  t (21) =",['Participants were 22 patients recruited from primary care who reported at least moderate depressive symptoms (score ≥ 10 on the Patient Health Questionnaire-9'],"['behavioral activation intervention', 'Brief behavioral activation intervention']","['depressive symptoms', 'patient engagement, satisfaction, acceptability, and treatment response', 'Depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",22.0,0.0933487,"Within-subject t tests revealed a significant reduction in depressive symptoms from baseline at the 12-week assessment, based on PHQ-9 total score,  t (21) =","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Funderburk', 'Affiliation': 'VA Center for Integrated Healthcare.'}, {'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'VA VISN 2 Center of Excellence for Suicide Prevention.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Shepardson', 'Affiliation': 'VA Center for Integrated Healthcare.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'VA Center for Integrated Healthcare.'}]",Psychological services,['10.1037/ser0000328']
730,29540420,Protocol for the economic evaluation of a complex intervention to improve the mental health of maltreated infants and children in foster care in the UK (The BeST? services trial).,"INTRODUCTION


Children who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors. Evidence suggests that early intervention can mitigate the negative consequences of child maltreatment, exerting long-term positive effects on the health of maltreated children entering foster care. However, evidence on cost-effectiveness of such complex interventions is limited. This protocol describes the first economic evaluation of its kind in the UK.
METHODS AND ANALYSIS


An economic evaluation alongside the Best Services Trial (BeST?) has been prospectively designed to identify, measure and value key resource and outcome impacts arising from the New Orleans intervention model (NIM) (an infant mental health service) compared with case management (CM) (enhanced social work services as usual). A within-trial economic evaluation and long-term model from a National Health Service/Personal Social Service and a broader societal perspective will be undertaken alongside the National Institute for Health Research (NIHR)-Public Health Research Unit (PHRU)-funded randomised multicentre BeST?. BeST? aims to evaluate NIM compared with CM for maltreated children entering foster care in a UK context. Collection of Paediatric Quality of Life Inventory (PedsQL) and the recent mapping of PedsQL to EuroQol-5-Dimensions (EQ-5D) will facilitate the estimation of quality-adjusted life years specific to the infant population for a cost-utility analysis. Other effectiveness outcomes will be incorporated into a cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA). A long-term economic model and multiple economic evaluation frameworks will provide decision-makers with a comprehensive, multiperspective guide regarding cost-effectiveness of NIM. The long-term population health economic model will be developed to synthesise trial data with routine linked data and key government sector parameters informed by literature. Methods guidance for population health economic evaluation will be adopted (lifetime horizon, 1.5% discount rate for costs and benefits, CCA framework, multisector perspective).
ETHICS AND DISSEMINATION


Ethics approval was obtained by the West of Scotland Ethics Committee. Results of the main trial and economic evaluation will be submitted for publication in a peer-reviewed journal as well as published in the peer-reviewed NIHR journals library (Public Health Research Programme).
TRIAL REGISTRATION NUMBER


NCT02653716; Pre-results.",2018,"This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors.","['maltreated infants and children in foster care in the UK', 'maltreated children entering foster care in a UK context']","['PedsQL to EuroQol-5-Dimensions (EQ-5D', 'complex intervention']","['cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA', 'mental health']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0580719', 'cui_str': 'Child in foster care (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}]","[{'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.145059,"This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Deidda', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kathleen Anne', 'Initials': 'KA', 'LastName': 'Boyd', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Minnis', 'Affiliation': 'Mental Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Donaldson', 'Affiliation': 'Glasgow Infant and Family Team, NSPCC, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Family Assessment and Contact Service, Glasgow, UK.'}, {'ForeName': 'Nicole R S', 'Initials': 'NRS', 'LastName': 'Boyer', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2017-020066']
731,30872116,"Loss of bronchoprotection with ICS plus LABA treatment, β-receptor dynamics, and the effect of alendronate.","BACKGROUND


Loss of bronchoprotection (LOBP) with a regularly used long-acting β 2 -adrenergic receptor agonist (LABA) is well documented. LOBP has been attributed to β 2 -adrenergic receptor (B2AR) downregulation, a process requiring farnesylation, which is inhibited by alendronate.
OBJECTIVE


We sought to determine whether alendronate can reduce LABA-associated LOBP in inhaled corticosteroid (ICS)-treated patients.
METHODS


We conducted a randomized, double-blind, placebo-controlled, parallel-design, proof-of-concept trial. Seventy-eight participants with persistent asthma receiving 250 μg of fluticasone twice daily for 2 weeks were randomized to receive alendronate or placebo while initiating salmeterol for 8 weeks. Salmeterol-protected methacholine challenges (SPMChs) and PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP ELISA) were assessed before randomization and after 8 weeks of ICS plus LABA treatment. LOBP was defined as a more than 1 doubling dose reduction in SPMCh PC 20  value.
RESULTS


The mean doubling dose reduction in SPMCh PC 20  value was 0.50 and 0.27 with alendronate and placebo, respectively (P = .62). Thirty-eight percent of participants receiving alendronate and 33% receiving placebo had LOBP (P = .81). The after/before ICS plus LABA treatment ratio of B2AR number was 1.0 for alendronate (P = .86) and 0.8 for placebo (P = .15; P = .31 for difference between treatments). The B2AR signaling ratio was 0.89 for alendronate (P = .43) and 1.02 for placebo (P = .84; P = .44 for difference). Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
CONCLUSION


This study did not find evidence that alendronate reduces LABA-associated LOBP, which relates to the occurrence of LOBP in only one third of participants. LOBP appears to be less common than presumed in concomitant ICS plus LABA-treated asthmatic patients. B2AR downregulation measured in PBMCs does not appear to reflect LOBP.",2019,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","['Seventy-eight participants with persistent asthma receiving 250\xa0μg of', 'twice daily for 2\xa0weeks', 'inhaled corticosteroid (ICS)-treated patients']","['salmeterol', 'placebo', 'fluticasone', 'alendronate or placebo', 'LOBP', 'Salmeterol-protected methacholine', 'alendronate']","['PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP', 'B2AR number', 'ELISA', 'B2AR downregulation measured in PBMCs', 'lung function and B2AR number and signaling', 'B2AR signaling ratio', 'LOBP']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",78.0,0.67113,"Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP.
","[{'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Departments of Environmental Health, Genetics & Complex Diseases, Harvard T.H. Chan School of Public Health, Boston, Mass.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Gerard', 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'McIntire', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass.""}, {'ForeName': 'Homer A', 'Initials': 'HA', 'LastName': 'Boushey', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Codispoti', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dyer', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Lemanske', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Njira', 'Initials': 'N', 'LastName': 'Lugogo', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pa.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moy', 'Affiliation': 'Department of Medicine, Rush University Medical Center and Department of Pediatrics, Stroger Hospital of Cook County, Chicago, Ill.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Solway', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Ill.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Sorkness', 'Affiliation': 'Departments of Medicine and Pharmacy Practice, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, National Jewish University, Denver, Colo.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Medicine, Pittsburgh University, Pittsburgh, Pa.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Mass. Electronic address: eisrael@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.049']
732,31755989,Lack of additive benefit of oral steroids on short-term postoperative outcomes in nasal polyposis.,"OBJECTIVES


There is a lack of evidence concerning the efficacy of oral corticosteroids (OCS) as a postoperative treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The objective of our study was to determine the short-term additive benefit of postoperative OCS in CRSwNP patients.
METHODS


We prospectively randomized CRSwNP patients who were treated by endoscopic sinus surgery. All patients were resistant to maximum medical treatment according to European position paper on rhinosinusitis and nasal polyps 2012 guidelines. Treatment group received postoperative OCS in descending doses plus nasal douching over a period of 4 weeks, whereas the control group received only nasal douching. The efficacy of OCS was determined by a total 5 item symptoms score (T5SS), polyp size score, Barcelona Smell Test 24 and Medical Outcome Study Short Form-36 questionnaire for quality of life (QoL).
RESULTS


Of the 70 enrolled patients, 35 were in the treatment group and 35 in the control group. After 4 weeks of follow-up, patients from both groups improved in T5SS, QoL, endoscopic findings (except for crusts that increased in both) and sense of smell, without significant differences between OCS and control groups.
CONCLUSION


Postoperative OCS as an add-on treatment for CRSwNP patients does not improve sinonasal and QoL outcomes; thus, they should not be routinely recommended.
LEVEL OF EVIDENCE


Ib Laryngoscope, 2019.",2020,"After 4 weeks of follow-up, patients from both groups improved in T5SS, QoL, endoscopic findings (except for crusts that increased in both) and sense of smell, without significant differences between OCS and control groups.
","['CRSwNP patients', 'All patients were resistant to maximum medical treatment according to European position paper on rhinosinusitis and nasal polyps 2012 guidelines', 'patients who were treated by endoscopic sinus surgery', 'patients with chronic rhinosinusitis with nasal polyps (CRSwNP', 'nasal polyposis', 'Of the 70 enrolled patients, 35 were in the treatment group and 35 in the control group']","['control group received only nasal douching', 'CRSwNP', 'postoperative OCS', 'oral corticosteroids (OCS', 'oral steroids']","['efficacy of OCS', 'total 5 item symptoms score (T5SS), polyp size score, Barcelona Smell Test 24 and Medical Outcome Study Short Form-36 questionnaire for quality of life (QoL', 'T5SS, QoL, endoscopic findings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0948780', 'cui_str': 'Rhinosinusitis'}, {'cui': 'C0027430', 'cui_str': 'Nasal Polyps'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4524092', 'cui_str': 'Chronic rhinosinusitis with nasal polyps'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0334108', 'cui_str': 'Multiple polyps (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456582', 'cui_str': 'Irrigation of nasal passages (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299212', 'cui_str': 'Polyp size'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",70.0,0.0552507,"After 4 weeks of follow-up, patients from both groups improved in T5SS, QoL, endoscopic findings (except for crusts that increased in both) and sense of smell, without significant differences between OCS and control groups.
","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Arancibia', 'Affiliation': 'Rhinology and Skull Base Unit, Department of Otorhinolaryngology, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Langdon', 'Affiliation': 'Rhinology and Skull Base Unit, Department of Otorhinolaryngology, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Mullol', 'Affiliation': 'Rhinology and Skull Base Unit, Department of Otorhinolaryngology, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isam', 'Initials': 'I', 'LastName': 'Alobid', 'Affiliation': 'Rhinology and Skull Base Unit, Department of Otorhinolaryngology, Hospital Clinic, Universitat de Barcelona, Barcelona, Spain.'}]",The Laryngoscope,['10.1002/lary.28347']
733,31687762,Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial.,"AIMS


Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs.
METHODS AND RESULTS


In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P < 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend < 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction > 0.10 for each).
CONCLUSION


Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.",2020,"There were no significant interactions between treatment with HDER vs warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction >0.10 for each).
","['21,105 patients with AF followed for an average of 2.8 years', 'patients with atrial fibrillation (AF', 'Patients with Atrial Fibrillation']","['edoxaban regimen (HDER), a lower-dose edoxaban regimen (LDER), or warfarin', 'edoxaban', 'HDER vs warfarin', 'Warfarin', 'vitamin K antagonist oral anticoagulants', 'Edoxaban']","['thromboembolic events, bleeding, and death', 'safety, efficacy', 'efficacy, safety, and net outcomes', 'CCI scores', 'Efficacy and Safety', 'efficacy, safety', 'Updated Charlson Comorbidity Index (CCI', 'annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI=0, 1, 2, 3 or\u2009≥\u20094']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index (assessment scale)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0264034,"There were no significant interactions between treatment with HDER vs warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction >0.10 for each).
","[{'ForeName': 'André M', 'Initials': 'AM', 'LastName': 'Nicolau', 'Affiliation': 'Escola Paulista de Medicina, Universidade Federal de São Paulo, Rua Botucatu, 720 São Paulo, Brazil.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Corbalan', 'Affiliation': 'Hospital Clinico Pontificia Universidad Catolica de Chile, Facultad de Medicina, Santiago, Chile.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Departamento de Cardiopneumologia, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zierhut', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Medical Affairs Antithrombotic & Cardiovascular Therapeutic Area, Zielstattstraße 48, 81379 Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kerschnitzki', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Medical Affairs Antithrombotic & Cardiovascular Therapeutic Area, Zielstattstraße 48, 81379 Munich, Germany.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Duris', 'Affiliation': 'Fakultná nemocnica s poliklinikou, Nové Zámky, Slovakia.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Juul-Möller', 'Affiliation': 'Skåne University Hospital (SUS), Malmö, Sweden.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Voitk', 'Affiliation': 'Department of Invasive Cardiology, Center of Cardiology, North Estonia Medical Center Foundation, J. Sütiste tee 19, 13419 Tallinn, Estonia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trevisan', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz061']
734,30702452,Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism.,"OBJECTIVE


The aim of the study was to assess the feasibility, satisfaction, and effectiveness of a care transition intervention with pharmacist home visit and subsequent anticoagulation expert consultation for patients with new episode of venous thromboembolism within a not-for-profit health care network.
METHODS


We randomized patients to the intervention or control. During the home visit, a clinical pharmacist assessed medication management proficiency, asked open-ended questions to discuss knowledge gaps, and distributed illustrated medication instructions. Subsequent consultation with anticoagulation expert further filled knowledge gaps. At 30 days, we assessed satisfaction with the intervention and also measured the quality of care transition, knowledge of anticoagulation and venous thromboembolism, and anticoagulant beliefs (level of agreement that anticoagulant is beneficial, is worrisome, and is confusing/difficult to take).
RESULTS


The mean ± SD time required to conduct home visits was 52.4 ± 20.5 minutes and most patients agreed that the intervention was helpful. In general, patients reported a high-quality care transition including having been advised of safety issues related to medications. Despite that, the mean percentage of knowledge items answered correctly among patients was low (51.5 versus 50.7 for intervention and controls, respectively). We did not find any significant difference between intervention and control patients for care transition quality, knowledge, or anticoagulant beliefs.
CONCLUSIONS


We executed a multicomponent intervention that was feasible and rated highly. Nevertheless, the intervention did not improve care transition quality, knowledge, or beliefs. Future research should examine whether alternate strategies potentially including some but not all components of our intervention would be more impactful.",2020,"We did not find any significant difference between intervention and control patients for care transition quality, knowledge, or anticoagulant beliefs.
","['Patients With Venous Thromboembolism', 'patients with new episode of venous thromboembolism within a not-for-profit health care network']","['Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation', 'care transition intervention with pharmacist home visit and subsequent anticoagulation expert consultation']","['care transition quality, knowledge, or beliefs', 'feasibility, satisfaction, and effectiveness', 'care transition quality, knowledge, or anticoagulant beliefs', 'quality of care transition, knowledge of anticoagulation and venous thromboembolism, and anticoagulant beliefs (level of agreement that anticoagulant is beneficial, is worrisome, and is confusing/difficult to take', 'mean ± SD time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0565959', 'cui_str': 'New episode (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}]","[{'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0445377,"We did not find any significant difference between intervention and control patients for care transition quality, knowledge, or anticoagulant beliefs.
","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'From the University of Massachusetts Memorial Health Care.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Landyn', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester, MA.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Meyers Primary Care Institute, a joint endeavor of University of Massachusetts Medical School, Reliant Medical Group, and Fallon Health, Worcester, MA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Burgwinkle', 'Affiliation': 'From the University of Massachusetts Memorial Health Care.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gore', 'Affiliation': 'From the University of Massachusetts Memorial Health Care.'}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Spencer', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldberg', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'From the University of Massachusetts Memorial Health Care.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Darling', 'Affiliation': 'From the University of Massachusetts Memorial Health Care.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Boudreaux', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'University of Massachusetts Medical School.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'University of Massachusetts Medical School.'}]",Journal of patient safety,['10.1097/PTS.0000000000000571']
735,31685078,Providing objective feedback in supervision in motivational interviewing: results from a randomized controlled trial.,"BACKGROUND


The effects of the use of objective feedback in supervision on the supervisory relationship and skill acquisition is unknown.
AIMS


The objective of this study was to evaluate the effects of two different types of objective feedback provided during supervision in motivational interviewing (MI) on: (a) the supervisory relationship, including potential feelings of discomfort/distress, provoked by the supervision sessions, and (b) the supervisees' skill acquisition.
METHOD


Data were obtained from a MI dissemination study conducted in five county councils across five county councils across Sweden. All 98 practitioners recorded sessions with standardized clients and were randomized to either systematic feedback based on only the behavioral component of a feedback protocol, or systematic feedback based on the entire protocol.
RESULTS


The two different ways to provide objective feedback did not negatively affect the supervisory relationship, or provoke discomfort/distress among the supervisees, and the group that received the behavioural component of the feedback protocol performed better on only two of the seven skill measures.
CONCLUSIONS


Objective feedback does not seem to negatively affect either the supervisor-supervisee working alliance or the supervisees' supervision experience. The observed differences in MI skill acquisition were small, and constructive replications are needed to ascertain the mode and complexity of feedback that optimizes practitioners' learning, while minimizing the sense of discomfort and distress.",2020,"The two different ways to provide objective feedback did not negatively affect the supervisory relationship, or provoke discomfort/distress among the supervisees, and the group that received the behavioural component of the feedback protocol performed better on only two of the seven skill measures.
","['All 98 practitioners recorded sessions with standardized clients', 'Data were obtained from a MI dissemination study conducted in five county councils across five county councils across Sweden']","['objective feedback provided during supervision in motivational interviewing (MI', 'systematic feedback based on only the behavioral component of a feedback protocol, or systematic feedback based on the entire protocol']",['MI skill acquisition'],"[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}]",[],98.0,0.0497211,"The two different ways to provide objective feedback did not negatively affect the supervisory relationship, or provoke discomfort/distress among the supervisees, and the group that received the behavioural component of the feedback protocol performed better on only two of the seven skill measures.
","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Beckman', 'Affiliation': 'Centre for Psychiatric Research, Karolinska Institutet, and Stockholm Health Care Services, Stockholm County Council, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Forsberg', 'Affiliation': 'MIC Lab AB, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindqvist', 'Affiliation': 'Centre for Psychiatric Research, Karolinska Institutet, and Stockholm Health Care Services, Stockholm County Council, Sweden.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000687']
736,31670008,Acute effects of whole-body vibration training on neuromuscular performance and mobility in hypoxia and normoxia in persons with multiple sclerosis: A crossover study.,"BACKGROUND


Whole-body vibration training (WBVT) has been used in people with relapsing-remitting multiple sclerosis (pwMS), showing improvements in different neuromuscular and mobility variables. However, the acute effects of this training are still unknown. The acute effects of WBVT on neuromuscular performance, mobility and rating of perceived exertion (RPE) were evaluated in 10 pwMS.
METHODS


Maximal voluntary isometric contraction (MVIC), central activation ratio (CAR), electromyography (EMG) of the vastus lateralis during isometric knee extension, Timed Up and Go Test (TUG), walking speed and RPE were assessed before and immediately after a session of WBVT (twelve 60-s bout of vibration; frequency 35 Hz; amplitude 4 mm; 1-min rest intervals) in both hypoxic and normoxic conditions.
RESULTS


EMG 0-100, 0-200 ms and peak EMG resulted in significant differences (p < 0.05) between normoxic and hypoxic sessions. The EMG activity tended to decrease in all phases after the hypoxic session, indicating possible influence of hypoxia on neuromuscular performance. No changes were found in CAR, MVIC, TUG and walking speed in both conditions.
CONCLUSION


Based on our results, as well as those obtained by other studies that have used WBVT with other populations, more studies with a higher sample and lower dose of vibration exposure should be conducted in pwMS.",2020,"RESULTS


EMG 0-100, 0-200 ms and peak EMG resulted in significant differences (p < 0.05) between normoxic and hypoxic sessions.","['people with relapsing-remitting multiple sclerosis (pwMS', 'persons with multiple sclerosis']","['Whole-body vibration training (WBVT', 'WBVT', 'whole-body vibration training']","['CAR, MVIC, TUG and walking speed in both conditions', 'Maximal voluntary isometric contraction (MVIC), central activation ratio (CAR), electromyography (EMG) of the vastus lateralis during isometric knee extension, Timed Up and Go Test (TUG), walking speed and RPE', 'neuromuscular performance, mobility and rating of perceived exertion (RPE', 'neuromuscular performance and mobility in hypoxia and normoxia', 'EMG activity']","[{'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0193753,"RESULTS


EMG 0-100, 0-200 ms and peak EMG resulted in significant differences (p < 0.05) between normoxic and hypoxic sessions.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Andreu', 'Affiliation': 'International Chair of Sports Medicine, Catholic University of San Antonio, Murcia, Spain; Sports Science Faculty, Catholic University of Murcia (UCAM), Spain.'}, {'ForeName': 'Domingo J', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Sports Science Faculty, Catholic University of Murcia (UCAM), Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ávila-Gandía', 'Affiliation': 'Department of Exercise Physiology, Catholic University, Murcia, Spain.'}, {'ForeName': 'Tomás T', 'Initials': 'TT', 'LastName': 'Freitas', 'Affiliation': 'UCAM Research Center for High Performance Sport, Catholic University, Murcia, Spain.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Chung', 'Affiliation': 'Sports Science Faculty, Catholic University of Murcia (UCAM), Spain; UCAM Research Center for High Performance Sport, Catholic University, Murcia, Spain.'}, {'ForeName': 'Jacobo Á', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'Sports Science Faculty, Catholic University of Murcia (UCAM), Spain. Electronic address: jararias@ucam.edu.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2019.101454']
737,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
738,25735200,Pathways to change: Use trajectories following trauma-informed treatment of women with co-occurring post-traumatic stress disorder and substance use disorders.,"INTRODUCTION AND AIMS


Despite advances towards integration of care for women with co-occurring substance use disorder (SUD) and post-traumatic stress disorder (PTSD), low abstinence rates following SUD/PTSD treatment remain the norm. The utility of investigating distinct substance use trajectories is a critical innovation in the detection and refining of effective interventions for this clinical population.
DESIGN AND METHODS


The present study reanalysed data from the largest randomised clinical trial to date for co-occurring SUD and PTSD in women (National Drug Abuse Treatment Clinical Trials Network; Women and Trauma Study). Randomised participants (n = 353) received one of two interventions in addition to treatment as usual for SUD: (i) trauma-informed integrative treatment for PTSD/SUD; or (ii) an active control psychoeducation course on women's health. The present study utilised latent growth mixture models (LGMM) with multiple groups to estimate women's substance use patterns during the 12-month follow-up period.
RESULTS


Findings provided support for three different trajectories of substance use in the post-treatment year: (i) consistently low likelihood and use frequency; (ii) consistently high likelihood and use frequency; and (iii) high likelihood and moderate use frequency. Covariate analyses revealed improvement in PTSD severity was associated with membership in a specific substance use trajectory, although receiving trauma-informed treatment was not. Additionally, SUD severity, age and after-care efforts were shown to be related to trajectory membership.
DISCUSSION AND CONCLUSIONS


Findings highlight the necessity of accounting for heterogeneity in post-treatment substance use, relevance of trauma-informed care in SUD recovery and benefits of incorporating methodologies like LGMM when evaluating SUD treatment outcomes.",2015,"Covariate analyses revealed improvement in PTSD severity was associated with membership in a specific substance use trajectory, although receiving trauma-informed treatment was not.","['women with co-occurring post-traumatic stress disorder and substance use disorders', 'women with co-occurring substance use disorder (SUD) and post-traumatic stress disorder (PTSD', 'Randomised participants (n = 353']",['two interventions in addition to treatment as usual for SUD: (i) trauma-informed integrative treatment for PTSD/SUD; or (ii) an active control psychoeducation course'],['PTSD severity'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0734863,"Covariate analyses revealed improvement in PTSD severity was associated with membership in a specific substance use trajectory, although receiving trauma-informed treatment was not.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'López-Castro', 'Affiliation': 'Department of Psychology, The City College of New York-CUNY, New York City, USA.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': ''}, {'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': ''}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Hien', 'Affiliation': ''}]",Drug and alcohol review,['10.1111/dar.12230']
739,30488093,External physical vibration lithecbole facilitating the expulsion of upper ureteric stones 1.0-2.0 cm after extracorporeal shock wave lithotripsy: a prospective randomized trial.,"To observe the efficacy and safety of External Physical Vibration Lithecbole (EPVL) in patients with upper ureteric stones 1.0-2.0 cm after extracorporeal shock wave lithotripsy (ESWL). A total of 271 patients with upper ureteric stones 1.0-2.0 cm were prospectively randomized into two groups. One hundred and twenty-seven cases in the treatment group accepted EPVL therapy and 144 cases as control after ESWL. The stone expulsion status and stone-free rates (SFRs) between two groups were compared at the 1st, 2nd and 4th weekends by imaging examinations. All of 271 patients were randomly assigned to two groups, of which 127 patients were included in the treatment group and 144 in the control group. EPVL was successful in assisting the discharge of stone fragments. The rate of stone expulsion at day 1 in the treatment group was significantly higher than in the control group (79.5% vs. 64.6%, P = 0.006). The SFRs of the 1st weekend (76.3% vs. 61.8%, P = 0.010), the 2nd weekend (88.2% vs. 77.1%, P = 0.017) and the 4th weekend (92.1% vs. 84.0%, P = 0.042) in the treatment group were all significantly higher than that in the control group. However, no statistical significance was found in complications between the two groups (P > 0.05). Furthermore, in the treatment group the patients were treated a mean 4.3 sessions of EPVL. EPVL and ESWL are ideal complementary partners in the treatment of upper ureteric stones 1.0-2.0 cm, satisfying both high SFR and low complication. This method is safe and reproducible in clinical practice, and it also needs large-scale multicenter prospective studies further to prove the above conclusions.",2020,"The rate of stone expulsion at day 1 in the treatment group was significantly higher than in the control group (79.5% vs. 64.6%, P = 0.006).","['patients with upper ureteric stones 1.0-2.0\xa0cm after extracorporeal shock wave lithotripsy (ESWL', 'upper ureteric stones 1.0-2.0\xa0cm', '271 patients were randomly assigned to two groups, of which 127 patients were included in the treatment group and 144 in the control group', '271 patients with upper ureteric stones 1.0-2.0\xa0cm']","['EPVL therapy', 'extracorporeal shock wave lithotripsy', 'EPVL and ESWL', 'External Physical Vibration Lithecbole (EPVL', 'EPVL', 'External physical vibration lithecbole']","['complications', 'rate of stone expulsion', 'stone expulsion status and stone-free rates (SFRs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",271.0,0.0168834,"The rate of stone expulsion at day 1 in the treatment group was significantly higher than in the control group (79.5% vs. 64.6%, P = 0.006).","[{'ForeName': 'Rong-Zhen', 'Initials': 'RZ', 'LastName': 'Tao', 'Affiliation': 'Department of Urology, The Affiliated Jiangning Hospital with Nanjing Medical University, Nanjing, 211100, Jiangsu, China.'}, {'ForeName': 'Qing-Lai', 'Initials': 'QL', 'LastName': 'Tang', 'Affiliation': 'Department of Urology, The Affiliated Jiangning Hospital with Nanjing Medical University, Nanjing, 211100, Jiangsu, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, The Affiliated Jiangning Hospital with Nanjing Medical University, Nanjing, 211100, Jiangsu, China.'}, {'ForeName': 'Chun-Ping', 'Initials': 'CP', 'LastName': 'Jia', 'Affiliation': 'Department of Urology, The Affiliated Jiangning Hospital with Nanjing Medical University, Nanjing, 211100, Jiangsu, China.'}, {'ForeName': 'Jian-Lin', 'Initials': 'JL', 'LastName': 'Lv', 'Affiliation': 'Department of Urology, The Affiliated Jiangning Hospital with Nanjing Medical University, Nanjing, 211100, Jiangsu, China. trz1891597@126.com.'}]",Urolithiasis,['10.1007/s00240-018-1100-8']
740,29393137,Uric Acid and Diabetic Nephropathy Risk.,"BACKGROUND


Diabetic nephropathy (DN) is the leading cause of end-stage renal disease (ESRD) in the western world. Current treatment methods, with better control of glycemia and blood pressure, including renin-angiotensin system blockade (RASB), appear to have slowed the DN progression rate but have not substantially decreased the annual incidence of new DN ESRD cases. Thus, new treatment targets are needed.
SUMMARY


Higher levels of serum uric acid (UA) are associated with increased risk of the clinical manifestations of DN in persons with types 1 and 2 diabetes. Also, UA is a strong predictor of DN progression. Two small, short-term, proof-of-concept clinical trials in which a minority of the patients had diabetes suggested that reduction of UA with allopurinol could decrease the rate of glomerular filtration rate (GFR) loss in persons with chronic kidney disease (CKD). However, a definitive trial to check whether UA reduction can benefit DN progression has not been conducted as yet. Preventing Early Renal Loss in Diabetes (PERL) is an ongoing trial in persons with type 1 diabetes and early to moderate GFR reduction. This 3-year randomized placebo controlled trial in 530 subjects is to check whether UA reduction with allopurinol can slow the rate of GFR decline as determined by the plasma disappearance of iohexol. Key Message: If the results of the PERL trial are positive, initiation of UA reduction treatment while GFR is relatively well preserved could delay ESRD in DN by 8-10 years, that is, considerably longer than the period that has been demonstrated for RASB. This could have important implications for the treatment of DN in particular and of CKD in general.",2018,Higher levels of serum uric acid (UA) are associated with increased risk of the clinical manifestations of DN in persons with types 1 and 2 diabetes.,"['530 subjects', 'persons with types 1 and 2 diabetes', 'persons with type 1 diabetes and early to moderate GFR reduction', 'persons with chronic kidney disease (CKD']","['allopurinol', 'placebo']","['glycemia and blood pressure, including renin-angiotensin system blockade (RASB', 'glomerular filtration rate (GFR) loss', 'serum uric acid (UA', 'Uric Acid and Diabetic Nephropathy Risk', 'plasma disappearance of iohexol']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035096'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}]",530.0,0.0408939,Higher levels of serum uric acid (UA) are associated with increased risk of the clinical manifestations of DN in persons with types 1 and 2 diabetes.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': ''}]",Contributions to nephrology,['10.1159/000484284']
741,29172593,Internet-based cognitive behavioral therapy versus psychoeducation control for illness anxiety disorder and somatic symptom disorder: A randomized controlled trial.,"OBJECTIVE


To examine the efficacy of an Internet-delivered cognitive-behavioral therapy (iCBT) program for health anxiety compared to an active psychoeducation control group.
METHOD


Individuals (N = 86, mean age: 30 years, 87% female) with a Diagnostic and Statistical Manual of Mental Disorders (5th ed.) diagnosis of illness anxiety disorder or somatic symptom disorder with health anxiety were randomized to either a 6-lesson clinician-guided iCBT program for health anxiety (n = 45) or an active control group who received anxiety psychoeducation, clinical support, and monitoring (control, n = 41) over a 12-week period.
RESULTS


Both groups experienced significant improvements between baseline and posttreatment on self-report measures of health anxiety, depression, general anxiety, and functional impairment. Intention-to-treat analyses indicated that the iCBT group experienced greater improvements in health anxiety on the Short Health Anxiety Inventory (SHAI) compared to controls (between-groups effect size = 1.39, 95% confidence interval [0.87, 1.93]), and a greater proportion of the iCBT group showed clinically reliable change on the SHAI (84% vs. 34% in the control group). Similarly, the iCBT group outperformed the control group on secondary measures of depression, generalized anxiety, functional impairment, maladaptive cognitions, body hypervigilance, safety behaviors and avoidance, and intolerance of uncertainty. Gains were maintained at 3-month follow-up in the iCBT group.
CONCLUSION


iCBT for health anxiety is more effective than psychoeducation, clinical support, and monitoring, and presents an efficacious and accessible treatment option for people with health anxiety. (PsycINFO Database Record",2018,"Both groups experienced significant improvements between baseline and posttreatment on self-report measures of health anxiety, depression, general anxiety, and functional impairment.","['30 years, 87% female) with a Diagnostic and Statistical Manual of Mental Disorders (5th ed', 'Individuals (N = 86, mean age', 'people with health anxiety', 'diagnosis of illness anxiety disorder or somatic symptom disorder with health anxiety', 'illness anxiety disorder and somatic symptom disorder']","['Internet-delivered cognitive-behavioral therapy (iCBT) program', '6-lesson clinician-guided iCBT program for health anxiety (n = 45) or an active control group who received anxiety psychoeducation, clinical support, and monitoring (control, n = 41) over a 12-week period', 'iCBT', 'Internet-based cognitive behavioral therapy versus psychoeducation control']","['health anxiety', 'SHAI', 'Short Health Anxiety Inventory (SHAI', 'self-report measures of health anxiety, depression, general anxiety, and functional impairment', 'depression, generalized anxiety, functional impairment, maladaptive cognitions, body hypervigilance, safety behaviors and avoidance, and intolerance of uncertainty']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4064938', 'cui_str': 'Illness anxiety disorder'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2959402', 'cui_str': 'Short health anxiety inventory (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]",,0.0355624,"Both groups experienced significant improvements between baseline and posttreatment on self-report measures of health anxiety, depression, general anxiety, and functional impairment.","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': 'School of Psychology, University of New South Wales.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St. Vincent's Hospital.""}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Uppal', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St. Vincent's Hospital.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mason', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St. Vincent's Hospital.""}, {'ForeName': 'Alison E J', 'Initials': 'AEJ', 'LastName': 'Mahoney', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St. Vincent's Hospital.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': ""Clinical Research Unit for Anxiety and Depression, School of Psychiatry, University of New South Wales at St. Vincent's Hospital.""}]",Journal of consulting and clinical psychology,['10.1037/ccp0000248']
742,31655622,"Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study).","OBJECTIVE


The objective of this randomized, placebo-controlled, double-blind, parallel group, trial was to assess the effect of ambrisentan on mean pulmonary arterial pressure (mPAP) in patients with systemic sclerosis (SSc) and mildly elevated pulmonary hypertension (PH).
METHODS


Thirty-eight SSc patients with mildly elevated mPAP at rest between 21 and 24 mmHg and/or > 30 mmHg during low-dose exercise were randomly assigned to treatment with either ambrisentan 5-10 mg/day or placebo. Right heart catheterization and further clinical parameters were assessed at baseline and after 6 months. The primary endpoint was the difference of mPAP change at rest between groups.
RESULTS


After 6 months, the two groups did not differ in the primary endpoint (ambrisentan mPAP - 1 ± 6.4 mmHg vs. placebo - 0.73 ± 3.59 mmHg at rest, p = 0.884). However, three patients from the placebo group but none of the ambrisentan group progressed to SSc-associated pulmonary arterial hypertension. Furthermore, ambrisentan treatment showed significant improvements in the secondary endpoints cardiac index (CI) and pulmonary vascular resistance (PVR) at rest (CI 0.36 ± 0.66 l/min/m 2  vs. - 0.31 ± 0.71 l/min/m 2 , p = 0.010; PVR - 0.70 ± 0.78 WU vs. 0.01 ± 0.71 WU, p = 0.012) and during exercise (CI 0.7 ± 0.81 l/min/m 2  vs. - 0.45 ± 1.36 l/min/m 2 , p = 0.015; PVR - 0.84 ± 0.48 WU vs. - 0.0032 ± 0.34 WU, p < 0.0001).
CONCLUSION


This is the first randomized, double-blind, placebo-controlled study testing the effect of ambrisentan in patients with mildly elevated mPAP and/or exercise PH. The primary endpoint change in mPAP did only tendentially improve in the ambrisentan group, but the significant improvement of other hemodynamic parameters points to a possible benefit of ambrisentan and will be helpful to design future trials.
TRIAL REGISTRATION


www.ClinicalTrials.gov, unique identifier NCT: NCT02290613 , registered 14 th  of November 2014.",2019,"After 6 months, the two groups did not differ in the primary endpoint (ambrisentan mPAP - 1 ± 6.4 mmHg vs. placebo - 0.73 ± 3.59 mmHg at rest, p = 0.884).","['Thirty-eight SSc patients with mildly elevated mPAP at rest between 21 and 24\u2009mmHg', 'patients with mildly elevated mPAP and/or exercise PH', 'patients with systemic sclerosis (SSc) and mildly elevated pulmonary hypertension (PH', 'mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis']","['placebo', 'ambrisentan', 'ambrisentan 5-10\u2009mg/day or placebo']","['secondary endpoints cardiac index (CI) and pulmonary vascular resistance (PVR', 'mean pulmonary arterial pressure (mPAP', 'mPAP', 'SSc-associated pulmonary arterial hypertension', 'mPAP change']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036421', 'cui_str': 'Systemic Scleroderma'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.759956,"After 6 months, the two groups did not differ in the primary endpoint (ambrisentan mPAP - 1 ± 6.4 mmHg vs. placebo - 0.73 ± 3.59 mmHg at rest, p = 0.884).","[{'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Marra', 'Affiliation': 'IRCCS SDN Research Institute, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Benjamin', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Eichstaedt', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Blank', 'Affiliation': 'Department of Rheumatology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bossone', 'Affiliation': 'Division of Cardiology, U.O.C. Rehabilitazione Cardiovascolare, A Cardarelli, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Coghlan', 'Affiliation': 'Cardiology Department, Royal Free Hospital, London, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Centre of Rheumatology, Royal Free Hospital, London, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Distler', 'Affiliation': 'Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Egenlauf', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Department of Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Satenik', 'Initials': 'S', 'LastName': 'Harutyunova', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Xanthouli', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany.'}, {'ForeName': 'Hanns-Martin', 'Initials': 'HM', 'LastName': 'Lorenz', 'Affiliation': ''}, {'ForeName': 'Ekkehard', 'Initials': 'E', 'LastName': 'Grünig', 'Affiliation': 'Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Röntgenstraße 1, 69126, Heidelberg, Germany. ekkehard.gruenig@med.uni-heidelberg.de.'}]",Arthritis research & therapy,['10.1186/s13075-019-1981-0']
743,30636490,Clinical Trial Assessment of Intermittent and Continuous Infusion Dose of N-Acetylcysteine on Redox Status of the Body in Patients with Sepsis Admitted to the ICU.,"PURPOSE


Conflicting results exist regarding the efficacy of N-acetyl cysteine (NAC) in sepsis treatment. A pivotal factor affecting the therapeutic potency of NAC in sepsis is timing and dosing of its infusion. We aimed to assess the effect of NAC on redox status of patients with sepsis and to compare its efficacy in intermittent and continuous infusion with the objective of developing the infusion regimen and optimizing the timing.
MATERIALS AND METHODS


A prospective, randomized clinical trial was designed to compare the antioxidative effect of NAC in intermittent infusion group (IV: 25 mg/kg bolus and then 25 mg/kg/8 hours 3 times) and continuous infusion group (IV: 25 mg/kg bolus and then 75 mg/kg over 24 hours) in 60 critically ill patients with sepsis (20 patients in each group). Blood samples were collected immediately before and after intervention for total antioxidant capacity (TAC) and malondialdehyde (MDA) assessment.
RESULTS


N-acetyl cysteine considerably increased TAC levels in both intermittent (0.68 ± 0.60;  P  value = .036) and continuous (0.69 ± 0.64;  P  value = .015) infusion groups when compared to placebo (0.61 ± 0.10); however, the difference in TAC levels between the intermittent and the continuous infusion did not reach statistical significance ( P  value = .942). Likewise, NAC treatment decreased MDA levels in both intermittent (19.45 ± 4.18;  P  value = 0.001) and continuous (22.47 ± 6.68;  P  value = .002) infusion groups when compared to placebo (31.76 ± 11.06), while the difference in MDA levels between the intermittent and the continuous infusion did not reach statistical significance ( P  value = .481).
CONCLUSION


Our data confirmed the antioxidative effect of NAC treatment in patients with sepsis, with no significant difference in intermittent and continuous infusion.",2020,"N-acetyl cysteine considerably increased TAC levels in both intermittent (0.68 ± 0.60; P value = .036) and continuous (0.69 ± 0.64; P value = .015) infusion groups when compared to placebo (0.61 ± 0.10); however, the difference in TAC levels between the intermittent and the continuous infusion did not reach statistical significance ( P value = .942).","['60 critically ill patients with sepsis (20 patients in each group', 'patients with sepsis', 'Patients with Sepsis Admitted to the ICU']","['placebo', 'NAC', 'N-acetyl cysteine', 'N-acetyl cysteine (NAC', 'Intermittent and Continuous Infusion Dose of N-Acetylcysteine']","['TAC levels', 'antioxidative effect', 'Blood samples', 'MDA levels', 'total antioxidant capacity (TAC) and malondialdehyde (MDA) assessment']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",60.0,0.0440963,"N-acetyl cysteine considerably increased TAC levels in both intermittent (0.68 ± 0.60; P value = .036) and continuous (0.69 ± 0.64; P value = .015) infusion groups when compared to placebo (0.61 ± 0.10); however, the difference in TAC levels between the intermittent and the continuous infusion did not reach statistical significance ( P value = .942).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Peivandi Yazdi', 'Affiliation': 'Lung Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Razavi', 'Affiliation': 'Lung Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Lung Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Boroumand', 'Affiliation': 'Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Clinical Research Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Isaac', 'Initials': 'SI', 'LastName': 'Hashemy', 'Affiliation': 'Surgical Oncology Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of intensive care medicine,['10.1177/0885066618823152']
744,30644784,"Identifying the barriers and perceptions of non-Hispanic black and Hispanic/Latino persons with uncontrolled type 2 diabetes for participation in a home Telemonitoring feasibility study: a quantitative analysis of those who declined participation, withdrew or were non-adherent.","Objectives:  Type 2 Diabetes Mellitus and its complications disproportionately affect non-Hispanic blacks and Hispanic/Latinos more than non-Hispanic whites. These disparities stem from complex interactions between biological, behavioral and socioeconomic factors. In recent years, telemedicine has been used to manage Type 2 Diabetes; however limited recruitment and retention of black and Hispanic/Latino patients into clinical trials exploring the use of telemedicine have necessitated the elucidation of their perceptions regarding participation in such trials. This study investigated patient-reported reasons for declining participation, prematurely terminating participation or demonstrating poor adherence to the study protocol in an ongoing randomized clinical trial, 'Feasibility of Telehealth Management of Diabetes Mellitus type 2 (T2DM) in Black and Hispanic Minority Patients'. Design:  Semi-structured interviews comprised of open-ended questions and prompts were conducted by telephone to gauge patients' actual and perceived challenges to participating in the trial and using telemedicine to manage their diabetes. Data were collated with that of the original clinical trial and subsequently content analyzed for overarching themes and trends. Results:  Eight semi-structured interviews were completed telephonically. Themes that emerged from analysis included disinterest (47%), inconvenience (33%), lack of perceived benefit (13%), lack of awareness of diabetes diagnosis (7%) and perceived lack of ability to fully participate in the study (7%). Conclusion:  Adoption of telemedicine to help minority patients manage diabetes holds promise but is limited by patient factors such as disinterest, inconvenience and lack of perceived benefit. Greater awareness and understanding of these issues will be critical as we strive for greater health equity in disparity patients with uncontrolled diabetes.",2020,"CONCLUSION


Adoption of telemedicine to help minority patients manage diabetes holds promise but is limited by patient factors such as disinterest, inconvenience and lack of perceived benefit.","['disparity patients with uncontrolled diabetes', 'Type 2 Diabetes Mellitus and its complications disproportionately affect non-Hispanic blacks and Hispanic/Latinos more than non-Hispanic whites', 'Diabetes Mellitus type 2 (T2DM) in Black and Hispanic Minority Patients']",['telemedicine'],['lack of awareness of diabetes diagnosis'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0589402', 'cui_str': 'Lack of awareness'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",,0.0285775,"CONCLUSION


Adoption of telemedicine to help minority patients manage diabetes holds promise but is limited by patient factors such as disinterest, inconvenience and lack of perceived benefit.","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tong', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Alyson K', 'Initials': 'AK', 'LastName': 'Myers', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Aditya A', 'Initials': 'AA', 'LastName': 'Bissoonauth', 'Affiliation': 'Department of Medicine, Division of Endocrinology, North Shore University Hospital, Northwell Health, Manhasset, NY, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Pekmezaris', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kozikowski', 'Affiliation': 'National Commission on Certification of Physician Assistants, Johns Creek, GA, USA.'}]",Ethnicity & health,['10.1080/13557858.2019.1566520']
745,31679170,Presession attention affects the acquisition of tacts and intraverbals.,"This study examined the effects of presession attention on the acquisition of tacts (Experiment 1) and intraverbals (Experiment 2) in children diagnosed with autism. Each participant experienced 3 conditions. In the first 2 conditions, participants experienced a 15-min interval of either presession attention (PA) or no presession attention (NPA) followed by a teaching session. The third condition was a control condition. Across experiments, all participants acquired the verbal operants assigned to the NPA condition, whereas only 4 of the 6 participants acquired the verbal operants assigned to the PA condition. Five of the 6 participants required fewer sessions to meet the mastery criterion and a shorter duration of training for the verbal operants assigned to the NPA condition as compared to the PA condition. These outcomes suggest that antecedent manipulations traditionally reserved for mand training can positively affect the acquisition of other verbal operants. Theoretical implications are discussed.",2020,Five of the 6 participants required fewer sessions to meet the mastery criterion and a shorter duration of training for the verbal operants assigned to the NPA condition as compared to the PA condition.,['children diagnosed with autism'],"['presession attention (PA) or no presession attention (NPA', 'presession attention']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}]",[],,0.0160894,Five of the 6 participants required fewer sessions to meet the mastery criterion and a shorter duration of training for the verbal operants assigned to the NPA condition as compared to the PA condition.,"[{'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Cengher', 'Affiliation': 'UMBC.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Fienup', 'Affiliation': 'Teachers College, Columbia University.'}]",Journal of applied behavior analysis,['10.1002/jaba.657']
746,30389377,"Resemblance of Diet Quality in Families of Youth with Type 1 Diabetes Participating in a Randomized Controlled Behavioral Nutrition Intervention Trial in Boston, MA (2010-2013): A Secondary Data Analysis.","BACKGROUND


Parent-child diet quality resemblance is unknown in families of youth with type 1 diabetes, for whom nutrition is central to disease management.
OBJECTIVE


Examine diet quality resemblance in families of youth with type 1 diabetes participating in a behavioral nutrition intervention trial and investigate whether treatment assignment or family meal frequency modifies resemblance.
DESIGN


This is a secondary data analysis from an 18-month randomized controlled trial conducted August 2010 to May 2013.
PARTICIPANTS/SETTING


Parent-youth dyads (N=136, child age=12.3±2.5 years) were recruited from a northeast US diabetes center.
MAIN OUTCOME MEASURES


Parent and child Healthy Eating Index-2005 (HEI-2005, reflecting adherence to 2005 Dietary Guidelines for Americans) and whole plant food density (WPFD, reflecting intervention target foods) were calculated from 3-day food records collected every 6 months.
STATISTICAL ANALYSIS


Linear random effects models adjusting for demographics and disease characteristics investigated parent-child diet quality resemblance. Separate models examined whether treatment assignment or family meal frequency modified resemblance. Three-way interaction terms examined whether resemblance changed over time by treatment assignment.
RESULTS


Time-varying parent and child HEI-2005 and WPFD were positively associated (P<0.001), and there were no interactions with family meals. Parent-child HEI-2005 resemblance was similar across treatment groups; however, parent-child WPFD resemblance was stronger in the intervention (β±standard error [SE]=.30±.06) vs control families (β±SE=.12±.05). Parent-child HEI-2005 resemblance was similar over time by treatment assignment, whereas parent-child WPFD resemblance increased over time for families in the intervention group (three-way interaction term β±SE=.03±.01).
CONCLUSIONS


Parent and youth diet quality were positively correlated in families of youth with type 1 diabetes. Resemblance was stronger in the intervention group for target foods, but not for a general measure of diet quality. The lack of effect modification by family meal frequency suggests that family diet quality resemblance is not contingent on shared meals.",2019,"RESULTS


Time-varying parent and child HEI-2005 and WPFD were positively associated (P<0.001), and there were no interactions with family meals.","['August 2010 to May\xa02013', 'N=136, child age=12.3±2.5 years) were recruited from a northeast US diabetes center', 'families of youth with type 1 diabetes participating in a behavioral nutrition intervention trial', 'Families of Youth with Type 1 Diabetes Participating in a Randomized Controlled Behavioral Nutrition Intervention Trial in Boston, MA (2010-2013', 'Parent-youth dyads ']",[],"['Time-varying parent and child HEI-2005 and WPFD', 'parent-child WPFD resemblance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.0458443,"RESULTS


Time-varying parent and child HEI-2005 and WPFD were positively associated (P<0.001), and there were no interactions with family meals.","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Lipsky', 'Affiliation': ''}, {'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Haynie', 'Affiliation': ''}, {'ForeName': 'Aiyi', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Tonja R', 'Initials': 'TR', 'LastName': 'Nansel', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2018.07.025']
747,31667542,A neural network-based algorithm for predicting the spontaneous passage of ureteral stones.,"In this study, a prototype artificial neural network model (ANN) was used to estimate the stone passage rate and to determine the effectivity of predictive factors on this rate in patients with ureteral stones. The retrospective study included a total of 192 patients with ureteral stones, comprising 128 (66.7%) men and 64 (33.3%) women. Patients were divided into two groups. Group 1 (n: 125) consisted of people who spontaneously passed their stones, Group 2 (n: 67) consisted of people who could not pass stones spontaneously. The groups were compared with regard to the relationship between input data and stone passage rate by using both ANN and standard statistical tests. To implement the ANN, the patients were randomly divided into three groups: (a) training group (n = 132), (b) validation group (n = 30), and (c) test group (n = 30). The accuracy rate of ANN in the estimation of the stone passage ratio was 99.1% in the group a, 89.9% in the group b, and 87.3% in the group c. It was revealed that certain criteria (stone size, body weight, pain score, ESR, and CRP) were relatively more significant for saving treatment cost and time and for avoiding unnecessary treatment. ANN can be highly useful for the avoidance of unnecessary interventions in patients with ureteral stones as it showed remarkably high performance in the estimation of stone passage rate (99.16%).",2020,ANN can be highly useful for the avoidance of unnecessary interventions in patients with ureteral stones as it showed remarkably high performance in the estimation of stone passage rate (99.16%).,"['192 patients with ureteral stones, comprising 128 (66.7%) men and 64 (33.3%) women', 'Group 2 (n: 67) consisted of people who could not pass stones spontaneously', 'patients with ureteral stones']",['prototype artificial neural network model (ANN'],"['stone passage rate', 'certain criteria (stone size, body weight, pain score, ESR, and CRP', 'stone passage ratio', 'accuracy rate of ANN']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517716', 'cui_str': 'Thirty-three point three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",192.0,0.0217724,ANN can be highly useful for the avoidance of unnecessary interventions in patients with ureteral stones as it showed remarkably high performance in the estimation of stone passage rate (99.16%).,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Solakhan', 'Affiliation': 'Department of Urology, Bahcesehir University School of Medicine, Istanbul, Turkey. msolakhan@hotmail.com.'}, {'ForeName': 'Serap Ulusam', 'Initials': 'SU', 'LastName': 'Seckiner', 'Affiliation': 'Department of Industrial Engineering, Gaziantep University School of Engineering, Gaziantep, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Seckiner', 'Affiliation': 'Department of Urology, Gaziantep University School of Medicine, Gaziantep, Turkey.'}]",Urolithiasis,['10.1007/s00240-019-01167-5']
748,29958127,Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial.,"BACKGROUND


Methamphetamine (METH) use poses a barrier to antiretroviral therapy (ART) adherence. We evaluated the efficacy of the individualized texting for adherence building (iTAB) intervention among persons living with HIV (PLWH) who meet criteria for METH use disorder. We examined daily associations between ART adherence and text-reported METH use and depressed mood.
METHODS


We conducted a single site, 2-arm, 6-week, pilot randomized clinical trial comparing a personalized, bidirectional, text messaging system (iTAB; n = 50) to an active control condition (n = 25). All participants received adherence psychoeducation and daily texts assessing METH use and depressed mood. The iTAB group received personalized daily ART reminder texts. ART adherence was monitored using Medication Event Monitoring System (MEMS) caps.
RESULTS


Response rates to daily ART reminder texts were high (79%), with good concordance between MEMS-derived and text-reported ART adherence (p < .001). Intervention groups did not differ in MEMS-derived ART adherence (68% iTAB, 70% active control; p = .68); however, participants in the iTAB group had fewer METH use days (median 14.4 iTAB, 22.0 active control; p = .05). Text-reported METH use, but not depressed mood, was associated with poorer MEMS-derived ART adherence.
CONCLUSIONS


High text response rates and good concordance between MEMS-derived and text-reported adherence suggests text messaging is a feasible intervention delivery approach that provides a valid indication of ART adherence. Reductions in METH use among iTAB participants suggest daily health reminders may help attenuate substance use. Further research is needed to substantiate daily text messaging as a harm reduction approach.",2018,"Intervention groups did not differ in MEMS-derived ART adherence (68% iTAB, 70% active control;","['users living with HIV', 'persons living with HIV (PLWH) who meet criteria for METH use disorder']","['individualized texting for adherence building (iTAB) intervention', 'Methamphetamine (METH', 'antiretroviral therapy', 'adherence psychoeducation and daily texts assessing METH', 'personalized, bidirectional, text messaging system (iTAB; n\u202f=\u202f50) to an active control condition', 'methamphetamine']","['ART adherence', 'MEMS-derived ART adherence']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}]",,0.216401,"Intervention groups did not differ in MEMS-derived ART adherence (68% iTAB, 70% active control;","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA. Electronic address: djmoore@ucsd.edu.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Pasipanodya', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Umlauf', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Rooney', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Gouaux', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Depp', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}, {'ForeName': 'J Hampton', 'Initials': 'JH', 'LastName': 'Atkinson', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Montoya', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, School of Medicine, La Jolla, CA, 92093, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.05.013']
749,29355350,Allocating under the influence: Effects of alcohol intoxication and social identification on in-group favoritism.,"The ""social lubrication"" function of alcohol during interpersonal interactions is well documented. However, less is known about the effects of alcohol consumption on group-level behavior. Empirical findings from social psychological literature suggest that individuals tend to favor those who are considered as members of their own social group. Not yet evaluated is how alcohol intoxication interacts with this group-level bias. Therefore, the current study examined experimentally the effects of intoxication on group bias. Ninety-four individuals (M age  = 20.18, SD = 2.36, 55 women, 39 men) were randomly assigned to consume an alcoholic (n = 48) or a placebo (n = 46) drink before completing manipulated allocation matrices, a task which measured the distribution of hypothetical monetary awards based on social groups. Results point to an interaction between drink condition and social group identification, whereby identification was significantly associated with in-group favoritism among intoxicated individuals only. Following alcohol consumption, participants with higher identification with their social group were more likely to demonstrate allocation strategies that favored their own group members. However, nonsignificant effects were observed for those in the placebo condition. The findings highlight how alcohol intoxication may facilitate group bias that results from social group identification. (PsycINFO Database Record",2018,"Following alcohol consumption, participants with higher identification with their social group were more likely to demonstrate allocation strategies that favored their own group members.","['Ninety-four individuals (M age  = 20.18, SD = 2.36, 55 women, 39 men']","['alcohol intoxication', 'placebo (n = 46) drink before completing manipulated allocation matrices, a task which measured the distribution of hypothetical monetary awards based on social groups', 'alcoholic']",[],"[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0001969', 'cui_str': 'Drunkenness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}, {'cui': 'C0687725', 'cui_str': 'Alcoholics'}]",[],94.0,0.0183471,"Following alcohol consumption, participants with higher identification with their social group were more likely to demonstrate allocation strategies that favored their own group members.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychology, Edge Hill University.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Heim', 'Affiliation': 'Department of Psychology, Edge Hill University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Monk', 'Affiliation': 'Department of Psychology, Edge Hill University.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Psychology, Edge Hill University.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Pollard', 'Affiliation': 'School of Psychology, University of Central Lancashire.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000186']
750,29239627,Clinical severity as a moderator of outcome in psychodynamic and dialectical behavior therapies for borderline personality disorder.,"The aim of the present study was to assess the effect of initial level of psychiatric severity on treatment outcome in psychodynamic therapy and dialectical behavior therapy (DBT) for borderline personality disorder (BPD). It was hypothesized that DBT would lead to better outcome for patients with high psychiatric severity, whereas dynamic treatment would lead to better outcome for patients with lower psychiatric severity. Data from the 5th-year follow-up of the Stockholm City Council's and the Karolinska Institute's Psychotherapy Project were used in the present study. A total of 106 female patients diagnosed with BPD with at least 2 past suicide attempts were randomized into object-relational psychotherapy (ORP; based on transference-focused psychotherapy), DBT, and treatment as usual. Patients' baseline global severity index was used as a moderator. Global Assessment of Functioning (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [American Psychiatric Association, 1994]) was used to examine outcome. There was a significant 3-way interaction of Time × Treatment × Severity. Post hoc analyses suggested that patients with lower levels of severity had significantly better outcomes in object-relational psychotherapy. For patients with higher severity, the 3 treatments resulted in similar outcomes in terms of level of functioning. Outcome of treatment for BPD might differ significantly for patients depending on their initial levels of overall psychiatric severity. If our findings are replicated for patients with low severity and supported for a high-severity sample, psychiatric severity can be used as a low-cost and effective tool to match patients with BPD to optimal treatments. (PsycINFO Database Record",2018,Post hoc analyses suggested that patients with lower levels of severity had significantly better outcomes in object-relational psychotherapy.,"['borderline personality disorder', 'patients with high psychiatric severity', '106 female patients diagnosed with BPD with at least 2 past suicide attempts', 'borderline personality disorder (BPD']","['DBT', 'psychodynamic and dialectical behavior therapies', 'object-relational psychotherapy (ORP; based on transference-focused psychotherapy), DBT', 'psychodynamic therapy and dialectical behavior therapy (DBT']","['overall psychiatric severity', 'level of functioning']","[{'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040678', 'cui_str': 'Transference'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",106.0,0.0378046,Post hoc analyses suggested that patients with lower levels of severity had significantly better outcomes in object-relational psychotherapy.,"[{'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Sahin', 'Affiliation': 'Gordon F. Derner School of Psychology.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Vinnars', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Gordon F. Derner School of Psychology.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wilczek', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institute.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Åsberg', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institute.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Gordon F. Derner School of Psychology.'}]",Personality disorders,['10.1037/per0000276']
751,5957603,"The action of ""metoclopramide"" on gastric emptying: a radiological assessment.",,1966,,[],['metoclopramide'],['gastric emptying'],[],"[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}]",,0.012222,,"[{'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Margieson', 'Affiliation': ''}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Sorby', 'Affiliation': ''}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Williams', 'Affiliation': ''}]",The Medical journal of Australia,[]
752,31606362,Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.,"OBJECTIVES


This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.
BACKGROUND


Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.
METHODS


The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.
RESULTS


Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).
CONCLUSIONS


Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).",2019,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","['20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial ', 'trial randomized patients hospitalized for HF to receive', '79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n\xa0=\xa037,883 [77.2%]; black, n\xa0=\xa011,180 [22.8', 'Decompensated Heart\xa0Failure', 'Decompensated Heart Failure', 'non-Hispanic white (n\xa0=\xa01,494) and black (n\xa0=\xa01,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e.,\xa0Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria', 'from May 2007 to August 2010 and was neutral for clinical endpoints']","['nesiritide or placebo', 'Nesiritide']","['30-day readmission', 'blood pressure and higher ejection fraction', 'mortality rates', 'hospital mortality']","[{'cui': 'C4517642', 'cui_str': '20.2 (qualifier value)'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}]",,0.20658,"Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina. Electronic address: stephen.greene@duke.edu.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Sciences (Alphabet), South San Francisco, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Matsouaka', 'Affiliation': 'Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Samman Tahhan', 'Affiliation': 'Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.011']
753,31606364,Hyperkalemia and Treatment With RAAS Inhibitors During Acute Heart Failure Hospitalizations and Their Association With Mortality.,"OBJECTIVES


This study investigated associations between incident hyperkalemia during acute heart failure (HF) hospitalizations and changes in renin-angiotensin-aldosterone system (RAAS) inhibitors.
BACKGROUND


Hyperkalemia is a potential complication of RAAS inhibitors. For patients with HF, fear of hyperkalemia may lead to failure to deliver guideline-recommended doses of RAAS inhibitors.
METHODS


Serum potassium concentrations were measured daily from baseline (<24 h after admission) until discharge or day 7 in 1,589 patients enrolled in the PROTECT (Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function) trial. Incident hyperkalemia was defined as at least 1 episode of potassium >5.0 mEq/l. The primary outcome was all-cause mortality at 180 days.
RESULTS


Overall, serum potassium concentrations increased from 4.3 ± 0.6 mEq/l at baseline to 4.5 ± 0.6 mEq/l at discharge or day 7 (p < 0.001). Patients developing incident hyperkalemia (n = 564; 35%) were more often taking mineralocorticoid antagonists (MRAs) therapy prior to hospitalization and were more likely to have them down-titrated during hospitalization, independent of confounders. Incident hyperkalemia was not associated with adverse outcomes. Yet, down-titration of MRAs during hospitalization was independently associated with 180-day mortality (hazard ratio [HR]: 1.73; 95% confidence interval [CI]: 1.15 to 2.60), regardless of incident hyperkalemia (p interaction  >0.10). Patients with incident hyperkalemia who were discharged with the same or increased dose of MRAs (HR: 0.52; 95% CI: 0.32 to 0.85) or angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) (HR: 0.47; 95% CI: 0.29 to 0.77) had a lower 180-day mortality.
CONCLUSIONS


Incident hyperkalemia is common in patients hospitalized for acute HF and is not associated with adverse outcomes. Incident hyperkalemia is associated with down-titration of MRAs, but patients who maintained or increased their dose of MRAs and/or ACE inhibitors/ARB during acute HF hospitalization had better 180-day survival.",2019,"Patients developing incident hyperkalemia (n = 564; 35%) were more often taking mineralocorticoid antagonists (MRAs) therapy prior to hospitalization and were more likely to have them down-titrated during hospitalization, independent of confounders.","['1,589 patients enrolled in the', 'Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function) trial']","['RAAS-Inhibitors', 'PROTECT (Placebo', 'Selective A1 Adenosine Receptor Antagonist Rolofylline', 'angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs']","['incident hyperkalemia', '180-day mortality', 'Overall, serum potassium concentrations', 'cause mortality', 'Incident hyperkalemia', '180-day survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0546817', 'cui_str': 'Hypervolemia (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936829', 'cui_str': 'Adenosine Receptor Antagonists'}, {'cui': 'C0166128', 'cui_str': 'rolofylline'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0014432', 'cui_str': 'Enzyme Inhibitors'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1589.0,0.301539,"Patients developing incident hyperkalemia (n = 564; 35%) were more often taking mineralocorticoid antagonists (MRAs) therapy prior to hospitalization and were more likely to have them down-titrated during hospitalization, independent of confounders.","[{'ForeName': 'Joost C', 'Initials': 'JC', 'LastName': 'Beusekamp', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Tromp', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands; Department of Cardiology, National Heart Centre Singapore, Singapore; Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Department of Cardiology, University of Hull, Hull, United Kingdom.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'University of California at San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, California.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Cardiology, Medical University, Clinical Military Hospital, Wroclaw, Poland.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Ouwerkerk', 'Affiliation': 'Department of Cardiology, National Heart Centre Singapore, Singapore; Department of Dermatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam Infection and Immunity Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'Department of Cardiology, University of Groningen, Groningen, the Netherlands. Electronic address: p.van.der.meer@umcg.nl.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.07.010']
754,30520758,Single-Dose Pharmacokinetics and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson Disease: A Comparison With Immediate-Release Carbidopa-Levodopa and With Extended-Release Carbidopa-Levodopa Capsules.,"OBJECTIVE


IPX203 is an investigational oral extended-release capsule formulation of carbidopa-levodopa (CD-LD). The aim of this study was to characterize the single-dose pharmacodynamics, pharmacokinetics, and safety of IPX203 in subjects with advanced Parkinson disease compared with immediate-release (IR) CD-LD and extended-release CD-LD (Rytary).
METHODS


This was a randomized, open-label, rater-blinded, multicenter, single-dose crossover study. Blinded clinicians assessed subject's motor state and Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III scores for up to 10 hours postdose. Duration of effect was determined using improvement thresholds in the MDS-UPDRS part III.
RESULTS


Levodopa concentrations increased rapidly and similarly across all 3 treatments and were sustained for a longer duration after IPX203 dosing. All treatments exhibited a rapid onset of pharmacodynamic effect, whereas IPX203 had a significantly longer duration of effect based on MDS-UPDRS part III scores compared with IR CD-LD (P < 0.0001) and Rytary (P ≤ 0.0290). IPX203 had a 2.7-hour advantage over IR CD-LD (P < 0.0001) and a 0.9-hour advantage over Rytary in ""off"" time (P = 0.023) and in ""good on"" time (2.6 hours more than IR CD-LD, P < 0.0001; 0.9 hours more than Rytary, P = 0.0259) as measured by the Investigator Assessment of Subject's Motor State. Subjects were 77% more likely to require rescue following IR CD-LD treatment compared with IPX203 (hazard ratio, 0.23; P < 0.0001). More subjects reported treatment-emergent adverse effects during IR CD-LD (28.0%) and IPX203 (19.2%) than during Rytary (8.0%) treatment.
CONCLUSIONS


Compared with Rytary and IR CD-LD, IPX203 had a longer pharmacodynamic effect consistent with LD pharmacokinetics for the 3 treatments. The safety and tolerability of IPX203 were similar to those of IR CD-LD and Rytary.",2019,"RESULTS


Levodopa concentrations increased rapidly and similarly across all 3 treatments and were sustained for a longer duration after IPX203 dosing.","['Patients With Advanced Parkinson Disease', 'subjects with advanced Parkinson disease compared with immediate-release (IR) CD-LD and extended-release CD-LD (Rytary']","['Immediate-Release Carbidopa-Levodopa and With Extended-Release Carbidopa-Levodopa Capsules', 'carbidopa-levodopa (CD-LD', 'IPX203']","['MDS-UPDRS part III scores', 'Levodopa concentrations', 'safety and tolerability of IPX203', ' time', ""subject's motor state and Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III scores""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C3872096', 'cui_str': 'Rytary'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa / Levodopa'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]",,0.0374887,"RESULTS


Levodopa concentrations increased rapidly and similarly across all 3 treatments and were sustained for a longer duration after IPX203 dosing.","[{'ForeName': 'Nishit B', 'Initials': 'NB', 'LastName': 'Modi', 'Affiliation': 'Impax Laboratories, LLC, Hayward, CA.'}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Mittur', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rubens', 'Affiliation': ''}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}]",Clinical neuropharmacology,['10.1097/WNF.0000000000000314']
755,31661579,Medication-overuse headache: The effect of a patient educational programme-A randomized controlled trial.,"BACKGROUND


Little is known about the effects of non-pharmacological interventions among medication-overuse headache (MOH) patients, although non-pharmacological approaches combined with pharmacological treatment are recommended. The objective was to evaluate the effect of an educational programme as an add-on to standard treatment.
METHODS


Medication-overuse headache patients were randomized (1:1) in a single-centre setting to standard treatment with 12 weeks of education (I-group) versus standard treatment (C-group). The primary outcome was measurement of reduction in headache days/last month at 9 months' follow-up. Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity and patient satisfaction. The between-group differences were analysed using a mixed-effects model for repeated measurements with a between group factor (I-group vs. C-group) and a time factor (baseline, 4 and 9 months).
RESULTS


Ninety-eight patients were randomized (I-group: n = 48, C-group: n = 50), with 40 and 39 patients completing the study, respectively. Intention-to-treat analyses showed that both groups experienced statistically significant reductions in headache days/last month (I-group: -4 ± 6 days (95% CI 2.47; 5.95), p < .001) versus C-group: -4 ± 9 days ([95% CI 1.53; 6.79], p = .003), but there were no significant differences between groups (mean ± SE):Δ: 0.7 days ([95% CI, -2.50; 3.93], p = .66). At follow-up, 85% from the I-group and 86% from C-group, no longer fulfilled the criteria for MOH.
CONCLUSION


The compliance rate was high, indicating that patients were motivated for receiving education, but we found no additional benefits of adding an educational programme to standard treatment. Future research focusing on the MOH complexity, group heterogeneity, duration and content of educational programmes is warranted.
SIGNIFICANCE


Randomized controlled trials (RCTs) of non-pharmacological intervention such as patient educational programmes are of great importance, as this approach is common in the clinical practice. Medication-overuse headache (MOH) is a heterogenetic patient group, which must be taken into account when conducting RCTs of non-pharmacological interventions. An educational programme based on Motivational Interviewing is well-tolerated among MOH patients, however, no superior effects were found from adding the educational programme to standard treatment versus standard treatment alone.",2020,"Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity, and patient satisfaction.","['Ninety-eight patients were randomized (I-group', 'n=48, C-group: n= 50), with 40 and 39 patients completing the study, respectively', 'MOH patients']","['educational program', 'patient educational program']","['compliance rate', 'headache intensity, acute medication intake, bothersomeness, disability, physical activity, and patient satisfaction', 'reduction in headache days/last month', 'headache days', 'Medication-overuse headache']","[{'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0522254', 'cui_str': 'Analgesic Overuse Headache'}]",98.0,0.124211,"Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity, and patient satisfaction.","[{'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Mose', 'Affiliation': 'Department of Neurology, University Hospital of Southern Denmark, Esbjerg, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Department of Neurology, Danish Headache Centre, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Gram', 'Affiliation': 'Research Unit of Health Sciences, University Hospital of Southern Denmark, Esbjerg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1500']
756,31676693,"Comparing Psoriatic Arthritis Low-field Magnetic Resonance Imaging, Ultrasound, and Clinical Outcomes: Data from the TICOPA Trial.","OBJECTIVE


The Tight Control of inflammation in Psoriatic arthritis (TICOPA; isrctn.com: ISRCTN30147736) trial compared standard care (StdC) and tight control (TC) in early psoriatic arthritis (PsA), demonstrating better outcomes for TC. This substudy evaluated the performance metrics of modern imaging outcomes and compared them to the clinical data.
METHODS


Non-contrast 0.2T magnetic resonance imaging (MRI; single hand) was assessed using the Outcomes in Rheumatology (OMERACT) PsA MRI Scoring System (PsAMRIS) with an additional global inflammation score. Ultrasound (US; same hand) was scored for greyscale, power Doppler, and erosions at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints and scores summated.
RESULTS


Seventy-eight patients had paired (baseline and 48 weeks) US data and 61 paired MRI data; 50 had matched clinical, MR, and US data. Significant within-group changes were seen for the inflammatory PsAMRIS components at MCP level: MRI global inflammation [median difference (range), standardized response mean (SRM)]: 3.25 (-5.0 to 12.0), 0.68; 1.0 (-4.5 to 17.5), 0.45 for TC and StdC, respectively. Similar within-group differences were obtained for US: 1.0 (-13.0 to 23.0), 0.45; 3.0 (-6.0 to 21.0), 0.77 for TC and StdC, respectively. No differences were seen between treatment groups. Significant correlations were found between baseline and change MRI and US scores. A significant correlation was found between baseline PsA disease activity scores and MRI global inflammation scores (Spearman ρ for MCP, PIP: 0.46, 0.63, respectively). No differences in erosion progression were observed.
CONCLUSION


The PsAMRIS and US inflammation scores demonstrated good responsiveness. No between-group differences were demonstrated, but this substudy was likely underpowered to determine differences between the 2 treatment strategies.",2020,No between group differences were demonstrated but this sub-study was likely underpowered to determine differences between the two treatment strategies.,['78 patients had paired (baseline and 48 weeks'],['standard care (StdC) and tight control (TC'],"['inflammatory PsAMRIS components at MCP level: MRI global inflammation (Median difference (range), Standardised Response Mean, SRM', 'erosion progression', 'grey scale, power Doppler and erosions at the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints and scores summated', 'baseline PsA disease activity scores and MRI global inflammation scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",78.0,0.056816,No between group differences were demonstrated but this sub-study was likely underpowered to determine differences between the two treatment strategies.,"[{'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK. p.helliwell@leeds.ac.uk.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Ne Siang', 'Initials': 'NS', 'LastName': 'Chew', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lettieri', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Moverley', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Freeston', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Nam', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Waxman', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'From the Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; Bradford Teaching Hospitals Foundation Trust, Bradford; York Teaching Hospitals NHS Foundation Trust, Scarborough General Hospital, Department of Rheumatology, Scarborough, UK.'}]",The Journal of rheumatology,['10.3899/jrheum.181385']
757,31664156,Repeated buffered acidic saline infusion in the human masseter muscle as a putative experimental pain model.,"This study investigated if repeated buffered acidic saline infusions into the masseter muscles induced muscle pain and mechanical sensitization. Fourteen healthy men participated in this double-blind, randomized, and placebo-controlled study. Two repeated infusions (day 1 and 3) were given in the masseter muscles with either a buffered acidic saline solution (pH 5.2) or an isotonic saline solution (pH 6) as control. After 10 days of wash-out, the experiment was repeated with the other substance. Pressure pain thresholds (PPT), pain intensity, maximum unassisted mouth opening (MUO), and pain drawings were assessed before, directly following, and after each infusion at 5, 15, and 30 min and on day 4 and 7. Fatigue and pain intensity were assessed after a one-minute chewing test 30 min after infusions and day 4 and 7. Acidic saline induced higher pain intensity than control day 3 up to 5 min after infusions, but did not affect PPT. The chewing test did not evoke higher fatigue during chewing or MUO or after acidic saline infusion compared to control. Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain. Hence, this model might not be superior to already existing experimental muscle pain models.",2019,Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain.,['Fourteen healthy men'],"['acidic saline infusions', 'buffered acidic saline solution (pH 5.2) or an isotonic saline solution (pH 6) as control', 'placebo', 'acidic saline', 'Acidic saline', 'acidic saline infusion']","['Pressure pain thresholds (PPT), pain intensity, maximum unassisted mouth opening (MUO), and pain drawings', 'muscle pain and mechanical sensitization', 'Fatigue and pain intensity', 'higher pain intensity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",14.0,0.386685,Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain.,"[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Louca Jounger', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden. Sofia.Louca@ki.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Eriksson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindskog', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oscarsson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Simonsson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Ernberg', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Christidis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}]",Scientific reports,['10.1038/s41598-019-51670-3']
758,30355464,"Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial.","BACKGROUND


Based on previous findings, we hypothesised that radiotherapy to the prostate would improve overall survival in men with metastatic prostate cancer, and that the benefit would be greatest in patients with a low metastatic burden. We aimed to compare standard of care for metastatic prostate cancer, with and without radiotherapy.
METHODS


We did a randomised controlled phase 3 trial at 117 hospitals in Switzerland and the UK. Eligible patients had newly diagnosed metastatic prostate cancer. We randomly allocated patients open-label in a 1:1 ratio to standard of care (control group) or standard of care and radiotherapy (radiotherapy group). Randomisation was stratified by hospital, age at randomisation, nodal involvement, WHO performance status, planned androgen deprivation therapy, planned docetaxel use (from December, 2015), and regular aspirin or non-steroidal anti-inflammatory drug use. Standard of care was lifelong androgen deprivation therapy, with up-front docetaxel permitted from December, 2015. Men allocated radiotherapy received either a daily (55 Gy in 20 fractions over 4 weeks) or weekly (36 Gy in six fractions over 6 weeks) schedule that was nominated before randomisation. The primary outcome was overall survival, measured as the number of deaths; this analysis had 90% power with a one-sided α of 2·5% for a hazard ratio (HR) of 0·75. Secondary outcomes were failure-free survival, progression-free survival, metastatic progression-free survival, prostate cancer-specific survival, and symptomatic local event-free survival. Analyses used Cox proportional hazards and flexible parametric models, adjusted for stratification factors. The primary outcome analysis was by intention to treat. Two prespecified subgroup analyses tested the effects of prostate radiotherapy by baseline metastatic burden and radiotherapy schedule. This trial is registered with ClinicalTrials.gov, number NCT00268476.
FINDINGS


Between Jan 22, 2013, and Sept 2, 2016, 2061 men underwent randomisation, 1029 were allocated the control and 1032 radiotherapy. Allocated groups were balanced, with a median age of 68 years (IQR 63-73) and median amount of prostate-specific antigen of 97 ng/mL (33-315). 367 (18%) patients received early docetaxel. 1082 (52%) participants nominated the daily radiotherapy schedule before randomisation and 979 (48%) the weekly schedule. 819 (40%) men had a low metastatic burden, 1120 (54%) had a high metastatic burden, and the metastatic burden was unknown for 122 (6%). Radiotherapy improved failure-free survival (HR 0·76, 95% CI 0·68-0·84; p<0·0001) but not overall survival (0·92, 0·80-1·06; p=0·266). Radiotherapy was well tolerated, with 48 (5%) adverse events (Radiation Therapy Oncology Group grade 3-4) reported during radiotherapy and 37 (4%) after radiotherapy. The proportion reporting at least one severe adverse event (Common Terminology Criteria for Adverse Events grade 3 or worse) was similar by treatment group in the safety population (398 [38%] with control and 380 [39%] with radiotherapy).
INTERPRETATION


Radiotherapy to the prostate did not improve overall survival for unselected patients with newly diagnosed metastatic prostate cancer.
FUNDING


Cancer Research UK, UK Medical Research Council, Swiss Group for Clinical Cancer Research, Astellas, Clovis Oncology, Janssen, Novartis, Pfizer, and Sanofi-Aventis.",2018,"Radiotherapy improved failure-free survival (HR 0·76, 95% CI 0·68-0·84; p<0·0001) but not overall survival (0·92, 0·80-1·06; p=0·266).","['117 hospitals in Switzerland and the UK', 'men with metastatic prostate cancer', 'unselected patients with newly diagnosed metastatic prostate cancer', '2061 men underwent randomisation, 1029 were allocated the', 'patients with a low metastatic burden', 'Eligible patients had newly diagnosed metastatic prostate cancer', 'Between Jan 22, 2013, and Sept 2, 2016']","['open-label in a 1:1 ratio to standard of care (control group) or standard of care and radiotherapy (radiotherapy group', 'control and 1032 radiotherapy', 'radiotherapy', 'docetaxel', 'prostate radiotherapy', 'Radiotherapy', 'aspirin or non-steroidal anti-inflammatory drug use', 'planned androgen deprivation therapy, planned docetaxel']","['number of deaths', 'failure-free survival, progression-free survival, metastatic progression-free survival, prostate cancer-specific survival, and symptomatic local event-free survival', 'failure-free survival', 'tolerated', 'intention to treat', 'adverse events', 'metastatic burden', 'overall survival']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2061.0,0.507054,"Radiotherapy improved failure-free survival (HR 0·76, 95% CI 0·68-0·84; p<0·0001) but not overall survival (0·92, 0·80-1·06; p=0·266).","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Academic Urology Unit, Royal Marsden Hospital, London, UK; Institute of Cancer Research, London, UK. Electronic address: chris.parker@icr.ac.uk.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Genito-Urinary Cancer Research Group, Department of Surgery, The Christie Hospital, Manchester, UK; Department of Urology, Salford Royal Hospitals, Manchester, UK.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Hoyle', 'Affiliation': 'Genito-Urinary Cancer Research Group, Department of Surgery, The Christie Hospital, Manchester, UK; Department of Urology, Salford Royal Hospitals, Manchester, UK.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Genito-Urinary Cancer Research Group, Department of Surgery, The Christie Hospital, Manchester, UK; The FASTMAN/Genito-Urinary Cancer Research Groups, Division of Cancer Sciences, and Belfast-Manchester Movember Centre of Excellence, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Alastair W S', 'Initials': 'AWS', 'LastName': 'Ritchie', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, UCL, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Department of Medical Oncology, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Cross', 'Affiliation': 'Department of Urology, St James University Hospital, Leeds, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic Urology Unit, Royal Marsden Hospital, London, UK; Institute of Cancer Research, London, UK.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Gillessen', 'Affiliation': 'Division of Cancer Sciences, University of Manchester and the Christie, Manchester, UK; Division of Oncology and Haematology, Kantonsspital, St Gallen, Switzerland.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Gilson', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Zafar I', 'Initials': 'ZI', 'LastName': 'Malik', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'Division of Cancer & Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'Faculty of Education, Health and Wellbeing, University of Wolverhampton, Wolverhampton, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Millman', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'J Martin', 'Initials': 'JM', 'LastName': 'Russell', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Thalmann', 'Affiliation': 'Department of Urology, University Hospital, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Amos', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Alonzi', 'Affiliation': 'Mount Vernon Cancer Centre, London, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Birtle', 'Affiliation': 'Rosemere Cancer Centre, Lancashire Teaching Hospitals, Preston, UK; School of Cancer Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Din', 'Affiliation': 'Department of Clinical Oncology, Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Douis', 'Affiliation': 'Department of Radiology, University Hospital Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Chinnamani', 'Initials': 'C', 'LastName': 'Eswar', 'Affiliation': 'The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'Portsmouth Oncology Centre, Queen Alexandra Hospital, Portsmouth, UK.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Gannon', 'Affiliation': 'Department of Health Services Research, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Jonnada', 'Affiliation': 'Department of Oncology, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Khaksar', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey County Hospital, Guildford, UK.""}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Joe M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Omi A', 'Initials': 'OA', 'LastName': 'Parikh', 'Affiliation': 'Department of Clinical Oncology, East Lancashire Hospitals NHS Trust, Blackburn, UK.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pedley', 'Affiliation': 'Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Delia M', 'Initials': 'DM', 'LastName': 'Pudney', 'Affiliation': 'Clinical Oncology, Singleton Hospital, Swansea, UK.'}, {'ForeName': 'Denise J', 'Initials': 'DJ', 'LastName': 'Sheehan', 'Affiliation': 'Exeter Oncology Centre, Royal Devon & Exeter Hospital, Exeter, UK.'}, {'ForeName': 'Narayanan Nair', 'Initials': 'NN', 'LastName': 'Srihari', 'Affiliation': 'Department of Oncology, Shrewsbury and Telford Hospitals NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'Anna T H', 'Initials': 'ATH', 'LastName': 'Tran', 'Affiliation': 'Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL), London, UK. Electronic address: mrcctu.stampede-publications@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)32486-3']
759,30194492,Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial.,"PURPOSE


Endocrine therapy (ET) used to reduce the risk of recurrence in hormone receptor-expressing disease (75% of breast cancers) is associated with worsening of climacteric symptoms with a negative impact on quality of life (QoL). Homeopathy might allow a better management of hot flushes (HF).
METHODS


In this multicenter randomized double-blind placebo-controlled phase III study ( ClinicalTrials.gov NCT01246427), we enrolled ≥ 18 years old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients should not be scheduled for chemotherapy or radiotherapy, and had no associated pathology known to induce HF. After a 2- to 4-week placebo administration, we randomly assigned (1:1) patients with HFS ≥ 10 using an interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo (Arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. Primary endpoint was assessed at 4-week post-randomization, as the variation between pre- and 4w-HFS. Secondary endpoints included HFS variation between pre- and 8w-HFS, compliance and tolerance assessed 8 weeks after randomization, and QoL and satisfaction assessed at 4- and 8-week post-randomization.
RESULTS


Two hundred ninety-nine patients were included, and 138 (46.2%) randomized (A, 65; P, 73). Median 4w-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different. However, 4w-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4w-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).
CONCLUSIONS


The efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.",2019,"Median 4w-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different.","['Two hundred ninety-nine patients', 'localized breast cancer patients', 'breast cancer patients', 'old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤\u20091, treated for at least 1\xa0month with adjuvant ET, and complaining about moderate to severe HF', 'enrolled ≥\u200918\xa0years']","['homeopathic medicine', 'placebo', 'HFS ≥\u200910 using an interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo', 'Endocrine therapy (ET', 'chemotherapy or radiotherapy']","['4w-QoL', '4w-HFS', 'Median 4w-HFS absolute variation', 'HF scores (HFS', 'HFS variation between pre- and 8w-HFS, compliance and tolerance assessed 8\xa0weeks after randomization, and QoL and satisfaction', 'quality of life (QoL']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0920324', 'cui_str': 'Homeopathic Remedies'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}]",299.0,0.513604,"Median 4w-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different.","[{'ForeName': 'Pierre-Etienne', 'Initials': 'PE', 'LastName': 'Heudel', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France. PierreEtienne.HEUDEL@lyon.unicancer.fr.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Van Praagh-Doreau', 'Affiliation': 'Centre Jean Perrin, 58, Rue Montalembert, 63011, Clermont-Ferrand, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Duvert', 'Affiliation': 'Centre Hospitalier, 3 Rue Adhémar, 26200, Montélimar, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cauvin', 'Affiliation': 'Centre Hospitalier, BP1125, 73011, Chambéry, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Hardy-Bessard', 'Affiliation': 'Clinique Armoricaine de Radiologie, 21 rue du Vieux Séminaire, 22000, Saint Brieuc, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Jacquin', 'Affiliation': 'Institut de Cancérologie Lucien Neuwirth, 108, avenue Albert-Raimond, 42270, Saint-Priest-en-Jarez, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Stefani', 'Affiliation': ""Centre hospitalier de la région d'Annecy, 1 avenue de l'hôpital, BP90074, 74374, Annecy, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Vincent', 'Affiliation': 'Centre hospitalier de Roanne, 28, Rue de Charlieu, 42300, Roanne, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Dramais', 'Affiliation': 'Centre hospitalier, 179, Boulevard Maréchal Juin, 26000, Valence, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Guastalla', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Blanc', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Belleville', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Lavergne', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, 28 rue Laennec, 69373, Lyon Cedex 08, France.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4449-x']
760,30324180,"Assessing Acceptability, Feasibility, and Preliminary Effectiveness of a Community-Based Participatory Research Curriculum for Community Members: A Contribution to the Development of a Community-Academia Research Partnership.","Purpose:  The community-based participatory research approach has been identified as a great asset in reducing health disparities through the integration of community members in all phases of the research process. It is essential to provide skills to community members to achieve successful research partnerships. The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the community-based participatory research training curriculum for community members.  Methods:  Using mixed-methods, noncomparative design, eight workshops were developed and tested. Workshops covered topics such as community-based participatory research principles, health disparities, ethics in community-based participatory research, and fundamentals of research methodology. A total of 25 community leaders were trained. Pre-/post-test knowledge (unpaired  t -test), retention rate, workshop satisfaction, and cognitive debriefing sessions were used to assess knowledge gained and acceptability and feasibility of the curriculum.  Results:  A retention rate of 100% and an average satisfaction of 92.68% were obtained. Preliminary effectiveness results indicate that there was an overall significant change in participant's knowledge before and after the curriculum ( p <0.001). In the cognitive debriefing, participants were satisfied with the organization and structure and found the curriculum feasible. Furthermore, participants identified the skills acquired to aid in being more effective in their communities and work with academic researchers. The following changes were recommended: workshops' order, time, practical activities, and level of language.  Discussion:  Findings from this study suggest that the curriculum was acceptable and feasible to community leaders and that it might provide skills to actively incorporate community members in research activities. A large randomized clinical trial (RCT) study to evaluate curriculum effectiveness is recommended.",2018,"The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the community-based participatory research training curriculum for community members.  ","['community members', '25 community leaders', 'Community Members']","['community-based participatory research training curriculum', 'Community-Based Participatory Research Curriculum']","['retention rate', 'time, practical activities, and level of language', 'retention rate, workshop satisfaction, and cognitive debriefing sessions']","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",25.0,0.0263064,"The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the community-based participatory research training curriculum for community members.  ","[{'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Jiménez-Chávez', 'Affiliation': 'School of Behavioral and Brain Sciences, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Rosario-Maldonado', 'Affiliation': 'Public Health Program, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Torres', 'Affiliation': 'School of Behavioral and Brain Sciences, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Ramos-Lucca', 'Affiliation': 'School of Behavioral and Brain Sciences, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Eida M', 'Initials': 'EM', 'LastName': 'Castro-Figueroa', 'Affiliation': 'School of Behavioral and Brain Sciences, Ponce Health Sciences University, Ponce, Puerto Rico.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Santiago', 'Affiliation': 'Public Health Program, University of Puerto Rico, Río Piedras, Puerto Rico.'}]",Health equity,['10.1089/heq.2018.0034']
761,30187221,Exploring reasons behind patient compliance with nutrition supplements before pelvic exenteration surgery.,"PURPOSE


Compliance with oral nutrition support (ONS) is poorly reported in the literature. Many factors influence compliance, which could mask the true benefits of preoperative ONS. Surgical oncology patients, including pelvic exenteration patients, are often requested by healthcare workers to consume nutrition supplements before surgery. Exploration of barriers and enablers to compliance with nutrition supplements is needed to improve patient compliance and understand the real impact of preoperative ONS.
METHOD


A qualitative study using semi-structured interviews was performed to investigate enablers and barriers to preoperative nutrition supplement compliance. Twenty participants who had been asked to consume 15 nutrition supplements, either immunonutrition or standard polymeric supplements, were interviewed. Inductive thematic analysis was used to determine major themes associated with compliance.
RESULTS


Twelve out of 20 participants were not compliant with recommended dosing. Well-nourished participants were more compliant than malnourished participants. Major themes associated with compliance were flavour, volume, texture, impact on dietary intake and motivation to consume supplements. Flavour differed between the two groups, negatively impacting compliance in the immunonutrition group. Volume, texture and impact on dietary intake also negatively impacted compliance whereas motivation positively impacted compliance.
CONCLUSION


To overcome barriers and enforce enablers with nutrition supplement compliance, it is essential healthcare workers implement individualised interventions, taking into account nutritional status. A range of flavours, minimal volume and low viscosity supplements should be provided to address individual preference and minimise poor compliance. Better-targeted education and regular motivation are needed to improve compliance.",2019,Well-nourished participants were more compliant than malnourished participants.,"['Surgical oncology patients, including pelvic exenteration patients, are often requested by healthcare workers to consume nutrition supplements before surgery', 'Twenty participants who had been asked to consume 15 nutrition supplements, either immunonutrition or standard polymeric supplements, were interviewed', 'Twelve out of 20 participants were not compliant with recommended dosing']","['nutrition supplements', 'oral nutrition support (ONS']","['flavour, volume, texture, impact on dietary intake and motivation to consume supplements']","[{'cui': 'C1515090', 'cui_str': 'Surgical Oncology'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030788', 'cui_str': 'Pelvic Exenteration'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",20.0,0.0166014,Well-nourished participants were more compliant than malnourished participants.,"[{'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Hogan', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, NSW, Australia. sophie.hogan@health.nsw.gov.au.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Solomon', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Carey', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4445-1']
762,30261805,Telementoring for improving primary care provider knowledge and competence in managing chronic pain: A randomised controlled trial.,"Introduction


Primary care providers are frequently unprepared to manage chronic pain adequately due in part to insufficient professional training. This study evaluated the effect of a telementoring intervention on knowledge and perceived competence related to chronic pain management.
Methods


The study design was a cluster randomised controlled trial. Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization. Primary care providers comprised the intervention group (n = 23) and the control group (n = 18). Providers in the intervention group attended telementoring sessions through the TelePain programme and presented patient cases at the beginning and end of their enrolled patients’ 12-week study period. TelePain sessions included a didactic presentation and telementoring for specific patient cases by a panel of pain specialists from the disciplines of pain medicine, internal medicine, anaesthesiology, rehabilitation medicine, psychiatry, addiction medicine, nursing and complementary and integrative pain management. Providers’ baseline and end-of-study knowledge and perceived competence in managing chronic pain were assessed by three questionnaires: Knowledge and Attitudes Survey Regarding Pain, the KnowPain-12 and the Perceived Competence Scale.
Results


Knowledge (Z = –0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = –0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group. These providers attended on average 12.5 sessions (range 0–31) while participating in the study.
Discussion


Further research is recommended to establish the effectiveness of this telementoring intervention.",2020,"Results Knowledge (Z = -0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = -0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group.","['Primary care clinics that were part of the University of Washington Medicine Telehealth network were the unit of randomization', 'managing chronic pain']","['TelePain programme', 'telementoring intervention', 'TelePain sessions']",[],"[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]",[],[],,0.181327,"Results Knowledge (Z = -0.34, p = 0.97 (Knowledge and Attitudes Survey Regarding Pain) and Z = 0.49, p = 0.62 (KnowPain-12)) and perceived competence (Z = -0.74, p = 0.46) did not increase for providers in the intervention group compared with providers in the control group.","[{'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Eaton', 'Affiliation': 'School of Nursing and Health Studies, University of Washington Bothell, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Godfrey', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Langford', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rue', 'Affiliation': 'School of Nursing, University of Washington Seattle, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Tauben', 'Affiliation': 'School of Medicine, University of Washington Seattle, USA.'}, {'ForeName': 'Ardith Z', 'Initials': 'AZ', 'LastName': 'Doorenbos', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X18802978']
763,30159604,Efficacy of Pennebaker's expressive writing intervention in reducing psychiatric symptoms among patients with first-time cancer diagnosis: a randomized clinical trial.,"PURPOSE


The aim of this randomized clinical trial was to examine the efficacy of Pennebaker's expressive writing intervention (EWI) in improving the perceived quality of life (QoL) and in reducing psychiatric symptoms among patients who received a cancer diagnosis.
METHODS


Seventy-one consecutively recruited patients who received a cancer diagnosis for the first time in their life were randomized into two groups: an EWI group (EWG: n = 35) and a control group (CG n = 36). At the baseline, anamnestic information was collected for all patients, and the patients completed a series of self-reported measures assessing psychiatric symptoms, alexithymia, and health-related QoL. A modified Pennebaker's EWI adapted to cancer diagnosis was also administered to the EWG. Six months later, 32 patients (EWG: n = 17, CG: n = 15) participated in the follow-up and filled out the same questionnaires.
RESULTS


The Pennebaker's EWI was effective in decreasing global psychopathology (d =  -.55). Small but significant effects were also observed for alexithymia levels and health-related QoL, with the EWG showing a reduction in alexithymia levels (d =  -.31) and an increase in the mental component of QoL (d = .31) compared to the CG.
CONCLUSIONS


Our findings indicate that the Pennebaker's EWI is effective in reducing the negative impact of cancer diagnosis on patients' mental health.",2019,"Small but significant effects were also observed for alexithymia levels and health-related QoL, with the EWG showing a reduction in alexithymia levels (d =  -.31) and an increase in the mental component of QoL (d = .31) compared to the CG.
","['patients who received a cancer diagnosis', '32 patients (EWG: n\u2009=\u200917, CG: n\u2009=\u200915) participated in the follow-up and filled out the same questionnaires', 'patients with first-time cancer diagnosis', 'Seventy-one consecutively recruited patients who received a cancer diagnosis for the first time in their life']","[""Pennebaker's expressive writing intervention (EWI"", ""Pennebaker's expressive writing intervention"", 'EWI group (EWG: n\u2009=\u200935) and a control group (CG n\u2009=\u200936']","['mental component of QoL', 'alexithymia levels', 'alexithymia levels and health-related QoL', 'global psychopathology', ""psychiatric symptoms, alexithymia, and health-related QoL. A modified Pennebaker's EWI adapted to cancer diagnosis"", 'psychiatric symptoms', 'perceived quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0034380'}]",71.0,0.0291672,"Small but significant effects were also observed for alexithymia levels and health-related QoL, with the EWG showing a reduction in alexithymia levels (d =  -.31) and an increase in the mental component of QoL (d = .31) compared to the CG.
","[{'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'La Marca', 'Affiliation': 'Faculty of Human and Social Sciences, UKE-Kore University of Enna, Enna, Italy. luana.lamarca@unikore.it.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Maniscalco', 'Affiliation': 'Faculty of Human and Social Sciences, UKE-Kore University of Enna, Enna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fabbiano', 'Affiliation': 'Department of Hematology and Oncology, Hospital Vincenzo Cervello, Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Verderame', 'Affiliation': 'Department of Hematology and Oncology, Hospital Vincenzo Cervello, Palermo, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Schimmenti', 'Affiliation': 'Faculty of Human and Social Sciences, UKE-Kore University of Enna, Enna, Italy.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4438-0']
764,30146666,"Reimagine: a randomized controlled trial of an online, symptom self-management curriculum among breast cancer survivors.","PURPOSE


Chronic pain, depression, and fatigue are common effects resulting from the cancer experience; new interventions are needed. This study examined the effect of Reimagine, an online symptom self-management curriculum that teaches coping skills, on key outcomes.
METHODS


Adult breast cancer survivors with chronic pain were recruited from the Army of Women volunteer registry for this randomized controlled trial and randomized 1:1 to Reimagine or usual care conditions. Electronic surveys collected demographic, clinical, and outcome data at baseline and 18 weeks post-intervention.
RESULTS


Participants (N = 89) were mean age 56.7 ± 8.7 years; 67% married; 58% employed; mean years since diagnosis 8.2 ± 6.6; and 89% were in remission or cured of their breast cancer. There was a significant difference in the change in depression scores for treatment (M = - 1.7, SD = 4.5) and usual care (M = 0.3, SD = 3.8) conditions; t(85) = - 2.3, p = .03. Difference in the change in fatigue scores was significant for treatment (M = 4.8, SD = 9.0) and usual care (M = 1.2, SD = 6.6) conditions; t(87) = 2.2, p = .03. Most Reimagine users (94%) would recommend the curriculum to others.
CONCLUSIONS


These results suggest that Reimagine has an effect on depression and fatigue symptoms for breast cancer survivors. Online programs can be a feasible and effective alternative to in-person support. Additional research is recommended with larger and more diverse samples.",2019,"Difference in the change in fatigue scores was significant for treatment (M = 4.8, SD = 9.0) and usual care (M = 1.2, SD = 6.6) conditions; t(87) = 2.2, p = .03.","['Participants (N\u2009=\u200989) were mean age 56.7\xa0±\xa08.7\xa0years; 67% married; 58% employed; mean years since diagnosis 8.2\xa0±\xa06.6; and 89% were in remission or cured of their breast cancer', 'Adult breast cancer survivors with chronic pain were recruited from the Army of Women volunteer registry', 'breast cancer survivors']","['Reimagine', 'online, symptom self-management curriculum', 'Reimagine or usual care conditions']","['depression and fatigue symptoms', 'depression scores', 'fatigue scores']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.133551,"Difference in the change in fatigue scores was significant for treatment (M = 4.8, SD = 9.0) and usual care (M = 1.2, SD = 6.6) conditions; t(87) = 2.2, p = .03.","[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Smith', 'Affiliation': 'Duke University School of Nursing, Box 3322, Durham, NC, 27710, USA. sophia.smith@duke.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'MacDermott', 'Affiliation': 'The MacDermott Method, Inc., 345 N. Maple Drive, Suite 208, Beverly Hills, CA, 90210, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Amarasekara', 'Affiliation': 'Duke University School of Nursing, Box 3322, Durham, NC, 27710, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Duke University School of Nursing, Box 3322, Durham, NC, 27710, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mayer', 'Affiliation': 'University of North Carolina at Chapel Hill School of Nursing, Chapel Hill, NC, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hockenberry', 'Affiliation': 'Duke University School of Nursing, Box 3322, Durham, NC, 27710, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-018-4431-7']
765,30161093,TWELVE-MONTH OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Fixed Versus As-needed Dosing.,"PURPOSE


To compare the clinical outcomes of aflibercept used with a fixed schedule with a pro-re-nata (PRN) retreatment regimen in patients affected by neovascular age-related macular degeneration.
METHODS


This is a prospective multicenter, noninferiority, propensity score-matched study evaluating the 12-month outcomes of aflibercept given either according to labeling or following a PRN regimen. Patients included in the latter group received one initial injection, followed by monthly visits and as-needed retreatment.
RESULTS


One-to-one matching resulted in fixed and PRN arms containing 92 eyes each. Visual acuity improved from baseline to 12 months in both the study groups. At Month 4, the fixed regimen was equivalent to the PRN regimen (mean difference: 1.75 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: -1.42 to +4.92). The pro-re-nata regimen failed to show noninferiority compared with the fixed regimen at both Month 8 (mean difference: 3.43 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: +0.25 to +6.22) and Month 12 (mean difference: 4.83 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: +1.37 to +8.29). All patients in the fixed group received seven injections. Patients included in the PRN arm received a mean of 5.5 ± 1.6 treatments.
CONCLUSIONS


Aflibercept given with a fixed treatment regimen produces better visual acuity outcomes than an individualized regimen.",2019,"At Month 4, the fixed regimen was equivalent to the PRN regimen (mean difference: 1.75 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: -1.42 to +4.92).",['patients affected by neovascular age-related macular degeneration'],"['aflibercept', 'pro-re-nata (PRN) retreatment regimen']","['visual acuity outcomes', 'Visual acuity']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0067792', 'cui_str': 'NATA'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",,0.12587,"At Month 4, the fixed regimen was equivalent to the PRN regimen (mean difference: 1.75 Early Treatment Diabetic Retinopathy Study letters, 95% confidence interval: -1.42 to +4.92).","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Veritti', 'Affiliation': 'Department of Medicine-Ophthalmology, University of Udine, Udine, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Sarao', 'Affiliation': 'Department of Medicine-Ophthalmology, University of Udine, Udine, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Missiroli', 'Affiliation': 'Department of Ophthalmology, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Department of Ophthalmology, University of Rome Tor Vergata, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Lanzetta', 'Affiliation': 'Department of Medicine-Ophthalmology, University of Udine, Udine, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002299']
766,29933355,Caffeine's Effects on an Upper-Body Resistance Exercise Workout.,"Salatto, RW, Arevalo, JA, Brown, LE, Wiersma, LD, and Coburn, JW. Caffeine's effects on an upper-body resistance exercise workout. J Strength Cond Res 34(6): 1643-1648, 2020-The purpose of this study was to examine the effects of caffeine on an upper-body resistance exercise workout. Fifteen men (mean ± SD: age, 23.1 ± 1.9 years; body mass, 89.1 ± 13.9 kg; height, 175 ± 6.1 cm) volunteered to come to the laboratory 3 times. During visit 1, 1-repetition maximum (RM) values were determined for the barbell bench press, incline barbell bench press, and dumbbell bench press exercises. For visit 2, subjects consumed either 800-mg caffeine or a placebo. Subjects then completed 3 sets to failure of each exercise using 80% of their 1RM. Visit 3 was the same as visit 2; however, participants consumed the opposite treatment as visit 2. Various perceptual measures were recorded before, during, and after the workouts. The results indicated that participants completed significantly more repetitions per set for the barbell bench press (4.80 ± 2.66) and incline barbell bench press (4.91 ± 2.29) in the caffeine condition compared with the placebo condition (4.42 ± 2.56 and 4.36 ± 2.11, respectively). Higher arousal scores were found in the caffeine condition. For vigor, participants reported higher scores with caffeine before warming up (caffeine = 10.20 ± 4.11, placebo = 6.20 ± 3.23) and mid workout (caffeine = 13.53 ± 2.29, placebo = 11.13 ± 2.79). These results suggest that caffeine has an ergogenic effect on strength workout performance due, at least in part, to positive effects on workout perception. Athletes and recreational lifters may want to consider the ingestion of caffeine before a resistance exercise workout.",2020,"For vigor, participants reported higher scores with caffeine before warming up (caffeine = 10.20 ± 4.11, placebo = 6.20 ± 3.23) and mid workout (caffeine = 13.53 ± 2.29, placebo = 11.13 ± 2.79).","['Fifteen men (mean ± SD: age, 23.1 ± 1.9 years; body mass, 89.1 ± 13.9 kg; height, 175 ± 6.1 cm) volunteered to come to the laboratory 3 times']","['800-mg caffeine', 'placebo', 'Caffeine', 'J Strength Cond Res XX(X', 'caffeine']","['Upper-Body Resistance Exercise Workout', 'strength workout performance', 'Higher arousal scores', 'Salatto, RW, Arevalo, JA, Brown, LE, Wiersma, LD, and Coburn, JW', '1-repetition maximum (RM) values']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0979866,"For vigor, participants reported higher scores with caffeine before warming up (caffeine = 10.20 ± 4.11, placebo = 6.20 ± 3.23) and mid workout (caffeine = 13.53 ± 2.29, placebo = 11.13 ± 2.79).","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Salatto', 'Affiliation': 'Department of Kinesiology, Center for Sport Performance, California State University, Fullerton, California.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Arevalo', 'Affiliation': ''}, {'ForeName': 'Lee E', 'Initials': 'LE', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Lenny D', 'Initials': 'LD', 'LastName': 'Wiersma', 'Affiliation': ''}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Coburn', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002697']
767,31632617,Targeting hyperarousal: Mantram Repetition Program for PTSD in US veterans.,"Background : Hyperarousal appears to play an important role in the development and maintenance of posttraumatic stress disorder (PTSD) symptoms, but current evidence-based treatments appear to address this symptom type less effectively than the other symptom clusters. The Mantram Repetition Program (MRP) is a meditation-based intervention that has previously been shown to improve symptoms of posttraumatic stress disorder (PTSD) and may be especially helpful for hyperarousal. If MRP is an effective tool for decreasing this often treatment-resistant symptom cluster, it may become an important clinical tool.  Objective : The goal of this secondary analysis was to examine the effect of the MRP on hyperarousal and other PTSD symptom clusters and to examine hyperarousal as a mediator of treatment response.  Method : Secondary analyses were conducted on data from a randomized controlled trial in which Veterans with PTSD ( n  = 173) were assigned to the MRP or a non-specific psychotherapy control and assessed pre-treatment, post-treatment and 8 weeks after treatment completion. The impact of the interventions on PTSD symptom clusters was examined, and time-lagged hierarchical linear modelling was applied to examine alternative mediation models.  Results : All PTSD symptom clusters improved in both treatments. MRP led to greater reductions in hyperarousal at post-treatment (Hedge's  g  = 0.57) and follow-up (Hedge's  g  = 0.52), and in numbing at post-treatment (Hedge's  g  = 0.47). Hyperarousal mediated reductions in the composite of the other PTSD symptom clusters. Although the reverse model was significant as well, the effect was weaker in this direction.  Conclusion : Interventions focused on the management of hyperarousal may play an important role in recovery from PTSD. The MRP appears efficacious in reducing hyperarousal, and thereby impacting other PTSD symptom clusters, as one pathway to facilitating recovery.",2019,"MRP led to greater reductions in hyperarousal at post-treatment (Hedge's  g  = 0.57) and follow-up (Hedge's  g  = 0.52), and in numbing at post-treatment (Hedge's  g  = 0.47).",['Veterans with PTSD ( n  = 173'],"['MRP', 'Mantram Repetition Program (MRP', ' ', 'MRP or a non-specific psychotherapy control and assessed pre-treatment, post-treatment']","['hyperarousal', 'All PTSD symptom clusters', 'PTSD symptom clusters']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",,0.0147034,"MRP led to greater reductions in hyperarousal at post-treatment (Hedge's  g  = 0.57) and follow-up (Hedge's  g  = 0.52), and in numbing at post-treatment (Hedge's  g  = 0.47).","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Crawford', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Talkovsky', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Jill E', 'Initials': 'JE', 'LastName': 'Bormann', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}]",European journal of psychotraumatology,['10.1080/20008198.2019.1665768']
768,31647564,Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial.,"INTRODUCTION


Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone.
METHODS


We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day.
RESULTS


Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction.
CONCLUSIONS


Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit.
IMPLICATIONS


A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097.",2020,SGR did not add significantly to helping women quit or reduce.,"['pregnant women quit smoking', 'Pregnant Smokers', '314 pregnant women from 14 prenatal clinics']","['Texting Program', 'SMS text-delivered scheduled gradual reduction (SGR) program plus support texts']","['7-day point prevalence abstinence at late pregnancy', 'reduction in cigarettes per day', 'quit rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}]",314.0,0.068689,SGR did not add significantly to helping women quit or reduce.,"[{'ForeName': 'Kathryn I', 'Initials': 'KI', 'LastName': 'Pollak', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Lyna', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Noonan', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bejarano Hernandez', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Subudhi', 'Affiliation': 'Doctor of Medicine Program, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, DUMC 3083, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Fish', 'Affiliation': 'Cancer Control and Population Sciences, Duke Cancer Institute, Durham, NC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz174']
769,30063558,EPIRETINAL MEMBRANE REMOVAL WITH FOVEAL-SPARING INTERNAL LIMITING MEMBRANE PEELING: A Pilot Study.,"PURPOSE


To compare the retinal sensitivity after complete internal limiting membrane (ILM) peeling with that after foveal-sparing ILM peeling during vitrectomy for Type I epiretinal membrane.
METHODS


This was a prospective, randomized, comparative study. Thirty-eight eyes were randomized to undergo complete peeling of the ILM (CP group) or peeling with foveal sparing (FS group). The main outcome measures were foveal and perifoveal retinal sensitivity, visual acuity, and central retinal thickness.
RESULTS


Foveal retinal sensitivity showed a significant improvement in the FS group (2.82 ± 0.85 dB, P = 0.037) versus a slight drop in the CP group (-0.66 ± 0.48 dB, P = 1). Perifoveal retinal sensitivity slightly improved in both groups (0.47 ± 0.37 dB, P = 1 in the CP group and 0.79 ± 0.42 dB, P = 0.77 in the FS group), showing a similar trend without significant differences. Significant improvements were observed in both visual acuity and central retinal thickness in both groups. However, three cases in the FS group showed epiretinal membrane recurrence and required revision surgery with complete ILM removal.
CONCLUSION


Internal limiting membrane peeling may reduce retinal sensitivity and significantly increase the incidence of microscotomas. However, the higher epiretinal membrane recurrence rate after the foveal-sparing technique limits the effectiveness of this procedure. Further studies must be conducted to determine if it is safe to leave a portion of the ILM in front of the fovea.",2019,"RESULTS


Foveal retinal sensitivity showed a significant improvement in the FS group (2.82 ± 0.85 dB, P = 0.037) versus a slight drop in the CP group (-0.66 ± 0.48 dB, P = 1).",['Thirty-eight eyes'],"['ILM (CP group) or peeling with foveal sparing (FS group', 'complete internal limiting membrane (ILM) peeling with that after foveal-sparing ILM peeling during vitrectomy']","['epiretinal membrane recurrence and required revision surgery', 'visual acuity and central retinal thickness', 'epiretinal membrane recurrence rate', 'Foveal retinal sensitivity', 'Perifoveal retinal sensitivity', 'retinal sensitivity', 'foveal and perifoveal retinal sensitivity, visual acuity, and central retinal thickness']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0339543', 'cui_str': 'Epiretinal Membrane'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",38.0,0.0632847,"RESULTS


Foveal retinal sensitivity showed a significant improvement in the FS group (2.82 ± 0.85 dB, P = 0.037) versus a slight drop in the CP group (-0.66 ± 0.48 dB, P = 1).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Morescalchi', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gambicorti', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cancarini', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Eye Clinic, Department of Health Sciences, University of Molise, Campobasso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Semeraro', 'Affiliation': 'Eye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002274']
770,30025623,Treatment Effectiveness of Novafon Local Vibration Voice Therapy for Dysphonia Treatment.,"BACKGROUND


The objective of this study was to explore the effectiveness of the five-week Novafon local vibration voice therapy (NLVVT) program with and without Novafon local vibration for dysphonia treatment.
METHODS


Twenty-two voice-disordered subjects were divided into two groups. The intervention group (IG) performed the NLVVT program and the control group (CG) had the same voice exercises of this program without local vibration.
RESULTS


After NLVVT, the IG showed significantly high results in all parameters of acoustics, multiparametric indices, and self-evaluation (all P values < 0.01). The CG revealed mostly much significantly lower results (P values < 0.05) or nonsignificant results for these parameters after the treatment. The intergroup comparison under consideration before and after NLVVT showed a large and significant treatment effect in voice quality (ie, narrowband spectrograms, and Acoustic Voice Quality Index), in which the IG had better treatment results. The aerodynamic measurement showed no significant changes for both groups after NLVVT (P value > 0.05).
CONCLUSION


After the NLVVT program both groups showed significant improvements of various voice measurements, in which the IG revealed better treatment results than the CG. However, next to voice exercises an extra benefit for local vibration with the Novafon appliance was assessed in voice quality.",2020,"After the NLVVT program both groups showed significant improvements of various voice measurements, in which the IG revealed better treatment results than the CG.","['Twenty-two voice-disordered subjects', 'Dysphonia Treatment']","['Novafon Local Vibration Voice Therapy', 'Novafon local vibration voice therapy (NLVVT) program with and without Novafon local vibration', 'NLVVT program and the control group (CG) had the same voice exercises of this program without local vibration']","['acoustics, multiparametric indices, and self-evaluation', 'voice quality (ie, narrowband spectrograms, and Acoustic Voice Quality Index', 'various voice measurements', 'voice quality']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589289', 'cui_str': 'Voice exercises (regime/therapy)'}]","[{'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0042943', 'cui_str': 'Voice Quality'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",22.0,0.012145,"After the NLVVT program both groups showed significant improvements of various voice measurements, in which the IG revealed better treatment results than the CG.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Barsties V Latoszek', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp, Belgium. Electronic address: ben.barsties@t-online.de.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.05.009']
771,30037711,Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial.,"BACKGROUND


Indwelling pleural catheters are an established management option for malignant pleural effusion and have advantages over talc slurry pleurodesis. The optimal regimen of drainage after indwelling pleural catheter insertion is debated and ranges from aggressive (daily) drainage to drainage only when symptomatic.
METHODS


AMPLE-2 was an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia. Patients with symptomatic malignant pleural effusions were randomly assigned (1:1) to the aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs ≥2), presence of trapped lung, and prior pleurodesis. Patients were followed up for 6 months. The primary outcome was mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days. Secondary outcomes included rates of spontaneous pleurodesis and self-reported quality-of-life measures. Results were analysed by an intention-to-treat approach. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000963527.
FINDINGS


Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups. The mean daily breathlessness scores did not differ significantly between the aggressive and symptom-guided drainage groups (geometric means 13·1 mm [95% CI 9·8-17·4] vs 17·3 mm [13·0-22·0]; ratio of geometric means 1·32 [95% CI 0·88-1·97]; p=0·18). More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37·2%] of 43 vs five [11·4%] of 44, p=0·0049) and at 6 months (19 [44·2%] vs seven [15·9%], p=0·004; hazard ratio 3·287 [95% CI 1·396-7·740]; p=0·0065). Patient-reported quality-of-life measures, assessed with EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L), were better in the aggressive group than in the symptom-guided group (estimated means 0·713 [95% CI 0·647-0·779] vs 0·601 [0·536-0·667]). The estimated difference in means was 0·112 (95% CI 0·0198-0·204; p=0·0174). Pain scores, total days spent in hospital, and mortality did not differ significantly between groups. Serious adverse events occurred in 11 (25·6%) of 43 patients in the aggressive drainage group and in 12 (27·3%) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (five in the aggressive group and six in the symptom-guided drainage group).
INTERPRETATION


We found no differences between the aggressive (daily) and the symptom-guided drainage regimens for indwelling pleural catheters in providing breathlessness control. These data indicate that daily indwelling pleural catheter drainage is more effective in promoting spontaneous pleurodesis and might improve quality of life.
FUNDING


Cancer Council of Western Australia and the Sir Charles Gairdner Research Advisory Group.",2018,"More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37·2%] of 43 vs five [11·4%] of 44, p=0·0049) and at 6 months (19 [44·2%] vs seven [15·9%], p=0·004; hazard ratio 3·287","['Patients with symptomatic malignant pleural effusions', 'Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups', '11 centres in Australia, New Zealand, Hong Kong, and Malaysia']","['Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2', 'AMPLE-2', 'aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs ≥2), presence of trapped lung, and prior pleurodesis']","['Pain scores, total days spent in hospital, and mortality', 'mean daily breathlessness score, measured by use of a 100 mm visual analogue scale', 'EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L', 'pleural infection', 'rates of spontaneous pleurodesis and self-reported quality-of-life measures', 'spontaneous pleurodesis', 'quality of life', 'mean daily breathlessness scores', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0080032', 'cui_str': 'Pleural Effusion, Malignant'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C1322293', 'cui_str': 'Pleural catheter (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2242587', 'cui_str': 'Trapped lung'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0919907'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",87.0,0.242395,"More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37·2%] of 43 vs five [11·4%] of 44, p=0·0049) and at 6 months (19 [44·2%] vs seven [15·9%], p=0·004; hazard ratio 3·287","[{'ForeName': 'Sanjeevan', 'Initials': 'S', 'LastName': 'Muruganandan', 'Affiliation': 'Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; Pleural Medicine Unit, Institute for Respiratory Health, Perth, WA, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Azzopardi', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Respiratory Medicine, Sunshine Coast University Hospital, Birtinya, QLD, Australia.'}, {'ForeName': 'Deirdre B', 'Initials': 'DB', 'LastName': 'Fitzgerald', 'Affiliation': 'Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; Pleural Medicine Unit, Institute for Respiratory Health, Perth, WA, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': 'Department of Respiratory Medicine, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Benjamin C H', 'Initials': 'BCH', 'LastName': 'Kwan', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Sutherland Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'David C L', 'Initials': 'DCL', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'De Chaneet', 'Affiliation': 'Saint John of God Hospital Bunbury, Bunbury, WA, Australia.'}, {'ForeName': 'Muhammad Redzwan S', 'Initials': 'MRS', 'LastName': 'Rashid Ali', 'Affiliation': 'Department of Respiratory Medicine, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, Malaysia; KPJ Johor Specialist Hospital, Johor Bahru, Malaysia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Yap', 'Affiliation': 'Respiratory Department, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Tobin', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Respiratory Department, Royal Perth Hospital, Perth, WA, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Garske', 'Affiliation': 'Wesley Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Phan T', 'Initials': 'PT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Stanley', 'Affiliation': 'Department of Respiratory Medicine, Fiona Stanley Hospital, Perth, WA, Australia.'}, {'ForeName': 'Natalia D', 'Initials': 'ND', 'LastName': 'Popowicz', 'Affiliation': 'Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; School of Allied Health, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kosky', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Pulmonary Physiology and General Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; Pleural Medicine Unit, Institute for Respiratory Health, Perth, WA, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Read', 'Affiliation': 'Pleural Medicine Unit, Institute for Respiratory Health, Perth, WA, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Charley A', 'Initials': 'CA', 'LastName': 'Budgeon', 'Affiliation': 'Centre for Applied Statistics and School of Population & Global Health, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feller-Kopman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'Centre for Applied Statistics and School of Population & Global Health, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Y C Gary', 'Initials': 'YCG', 'LastName': 'Lee', 'Affiliation': 'Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; Pleural Medicine Unit, Institute for Respiratory Health, Perth, WA, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia. Electronic address: gary.lee@uwa.edu.au.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(18)30288-1']
772,29926752,Characterizing the Placebo Response in Adults With ADHD.,"Objective:  Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD.  Method : A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners' Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted.  Results : Pre-post changes in placebo-treated adults were significant for both the CAARS and ASRS,  F (2.9, 404.5) = 61.2,  p  < .00001,  F (2.8, 383.0) = 43.1,  p  < .00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR.  Conclusion : In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator-rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.",2020,"RESULTS


Pre-post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p < .00001, F(2.8, 383.0) =","['arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6', 'Adults With ADHD']",['placebo'],"[""Conners' Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS""]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",140.0,0.336513,"RESULTS


Pre-post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p < .00001, F(2.8, 383.0) =","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ben-Sheetrit', 'Affiliation': 'Geha Mental Health Center, Petah Tikva, Israel.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Peskin', 'Affiliation': 'Geha Mental Health Center, Petah Tikva, Israel.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Daniely', 'Affiliation': 'The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Shbiro', 'Affiliation': 'Geha Mental Health Center, Petah Tikva, Israel.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Rotem', 'Affiliation': 'Geha Mental Health Center, Petah Tikva, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Weizman', 'Affiliation': 'Geha Mental Health Center, Petah Tikva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Manor', 'Affiliation': 'Geha Mental Health Center, Petah Tikva, Israel.'}]",Journal of attention disorders,['10.1177/1087054718780328']
773,29726344,Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial.,"BACKGROUND


Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression.
METHODS


In this randomised, multicentre, non-inferiority clinical trial, we recruited patients who were referred to specialty neurostimulation centres based at three Canadian university hospitals (Centre for Addiction and Mental Health and Toronto Western Hospital, Toronto, ON, and University of British Columbia Hospital, Vancouver, BC). Participants were aged 18-65 years, were diagnosed with a current treatment-resistant major depressive episode or could not tolerate at least two antidepressants in the current episode, were receiving stable antidepressant medication doses for at least 4 weeks before baseline, and had an HRSD-17 score of at least 18. Participants were randomly allocated (1:1) to treatment groups (10 Hz rTMS or iTBS) by use of a random permuted block method, with stratification by site and number of adequate trials in which the antidepressants were unsuccessful. Treatment was delivered open-label but investigators and outcome assessors were masked to treatment groups. Participants were treated with 10 Hz rTMS or iTBS to the left dorsolateral prefrontal cortex, administered on 5 days a week for 4-6 weeks. The primary outcome measure was change in 17-item Hamilton Rating Scale for Depression (HRSD-17) score, with a non-inferiority margin of 2·25 points. For the primary outcome measure, we did a per-protocol analysis of all participants who were randomly allocated to groups and who attained the primary completion point of 4 weeks. This trial is registered with ClinicalTrials.gov, number NCT01887782.
FINDINGS


Between Sept 3, 2013, and Oct 3, 2016, we randomly allocated 205 participants to receive 10 Hz rTMS and 209 participants to receive iTBS. 192 (94%) participants in the 10 Hz rTMS group and 193 (92%) in the iTBS group were assessed for the primary outcome after 4-6 weeks of treatment. HRSD-17 scores improved from 23·5 (SD 4·4) to 13·4 (7·8) in the 10 Hz rTMS group and from 23·6 (4·3) to 13·4 (7·9) in the iTBS group (adjusted difference  0·103 [corrected], lower 95% CI -1·16; p=0·0011), which indicated non-inferiority of iTBS. Self-rated intensity of pain associated with treatment was greater in the iTBS group than in the 10 Hz rTMS group (mean score on verbal analogue scale 3·8 [SD 2·0] vs 3·4 [2·0] out of 10; p=0·011). Dropout rates did not differ between groups (10 Hz rTMS: 13 [6%] of 205 participants; iTBS: 16 [8%] of 209 participants); p=0·6004). The most common treatment-related adverse event was headache in both groups (10 Hz rTMS: 131 [64%] of 204; iTBS: 136 [65%] of 208).
INTERPRETATION


In patients with treatment-resistant depression, iTBS was non-inferior to 10 Hz rTMS for the treatment of depression. Both treatments had low numbers of dropouts and similar side-effects, safety, and tolerability profiles. By use of iTBS, the number of patients treated per day with current rTMS devices can be increased several times without compromising clinical effectiveness.
FUNDING


Canadian Institutes of Health Research.",2018,Self-rated intensity of pain associated with treatment was greater in the iTBS group than in the 10 Hz rTMS group (mean score on verbal analogue scale 3·8 [SD 2·0] vs 3·4 [2·0] out of 10; p=0·011).,"['patients with depression (THREE-D', 'patients who were referred to specialty neurostimulation centres based at three Canadian university hospitals (Centre for Addiction and Mental Health and Toronto Western Hospital, Toronto, ON, and University of British Columbia Hospital, Vancouver, BC', 'Participants were aged 18-65 years, were diagnosed with a current treatment-resistant major depressive episode or could not tolerate at least two antidepressants in the current episode, were receiving stable antidepressant medication doses for at least 4 weeks before baseline, and had an HRSD-17 score of at least 18', 'adults with treatment-resistant depression']","['open-label', 'Intermittent theta burst stimulation (iTBS', 'theta burst versus high-frequency repetitive transcranial magnetic stimulation', 'Hz rTMS or iTBS', '10 Hz rTMS', 'iTBS', 'repetitive transcranial magnetic stimulation (rTMS', '10 Hz rTMS or iTBS', 'standard 10 Hz rTMS', 'Hz rTMS']","['change in 17-item Hamilton Rating Scale for Depression (HRSD-17) score, with a non-inferiority margin of 2·25 points', 'Self-rated intensity of pain', 'Dropout rates', 'clinical effectiveness, safety, and tolerability of iTBS', 'low numbers of dropouts and similar side-effects, safety, and tolerability profiles', 'HRSD-17 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",205.0,0.249862,Self-rated intensity of pain associated with treatment was greater in the iTBS group than in the 10 Hz rTMS group (mean score on verbal analogue scale 3·8 [SD 2·0] vs 3·4 [2·0] out of 10; p=0·011).,"[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention at the Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada. Electronic address: daniel.blumberger@camh.ca.'}, {'ForeName': 'Fidel', 'Initials': 'F', 'LastName': 'Vila-Rodriguez', 'Affiliation': 'Non-Invasive Neurostimulation Therapies (NINET) Laboratory, University of British Columbia, Vancouver, BC, Canada; Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Faculty of Medicine and Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada; Applied Health Research Centre (AHRC), St Michael's Hospital, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Kfir', 'Initials': 'K', 'LastName': 'Feffer', 'Affiliation': 'Shalvata Mental Health Centre, Hod-Hasharon, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Noda', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, Keio University, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Giacobbe', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Centre for Mental Health, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention at the Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada; Krembil Research Institute, University Health Network, Toronto, ON, Canada.""}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention at the Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada; Centre for Mental Health, University Health Network, Toronto, ON, Canada; MRI-Guided rTMS Clinic, University Health Network, Toronto, ON, Canada; Krembil Research Institute, University Health Network, Toronto, ON, Canada.'}]","Lancet (London, England)",['10.1016/S0140-6736(18)30295-2']
774,29705116,Environmental or Nasal Cannula Supplemental Oxygen for Preterm Infants: A Randomized Cross-Over Trial.,"OBJECTIVE


To test the hypothesis that environmental compared with nasal cannula oxygen decreases episodes of intermittent hypoxemia (oxygen saturations <85% for ≥10 seconds) in preterm infants on supplemental oxygen by providing a more stable hypopharyngeal oxygen concentration.
STUDY DESIGN


This was a single center randomized crossover trial with a 1:1 parallel allocation to order of testing. Preterm infants on supplemental oxygen via oxygen environment maintained by a servo-controlled system or nasal cannula with flow rates ≤1.0 L per kg per minute were crossed over every 24 hours for 96 hours. Data were collected electronically to capture real time numeric and waveform data from patient monitors.
RESULTS


Twenty-five infants with gestational age of 27 ± 2 weeks (mean ± SD) and a birth weight of 933 ± 328 g were studied at postnatal day 36 ± 26. The number of episodes of intermittent hypoxemia per 24 hours was 117 ± 77 (median, 98; range, 4-335) with oxygen environment vs 130 ± 63 (median, 136; range, 16-252) with nasal cannula (P = .002). Infants on oxygen environment compared with nasal cannula also had decreased episodes of severe intermittent hypoxemia (P = .005). Infants on oxygen environment compared with nasal cannula had a lower proportion of time with oxygen saturations <85% (.05 ± .03 vs .06 ± .03, P < .001), and a lower coefficient of variation of oxygen saturation (P = .02).
CONCLUSIONS


In preterm infants receiving supplemental oxygen, servo-controlled oxygen environment decreases hypoxemia compared with nasal cannula.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02794662.",2018,Infants on oxygen environment compared with nasal cannula also had decreased episodes of severe intermittent hypoxemia (P = .005).,"['Preterm infants on', 'Preterm Infants', 'preterm infants receiving', 'Twenty-five infants with gestational age of 27\u2009±\u20092 weeks (mean\u2009±\u2009SD) and a birth weight of 933\u2009±']","['supplemental oxygen via oxygen environment maintained by a servo-controlled system or nasal cannula', 'Environmental or Nasal Cannula Supplemental Oxygen', 'supplemental oxygen, servo-controlled oxygen environment', 'nasal cannula oxygen']","['episodes of severe intermittent hypoxemia', 'variation of oxygen saturation', 'hypoxemia', 'intermittent hypoxemia (oxygen saturations', 'proportion of time with oxygen saturations', 'number of episodes of intermittent hypoxemia']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",25.0,0.505431,Infants on oxygen environment compared with nasal cannula also had decreased episodes of severe intermittent hypoxemia (P = .005).,"[{'ForeName': 'Colm P', 'Initials': 'CP', 'LastName': 'Travers', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL. Electronic address: ctravers@peds.uab.edu.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Nakhmani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Gentle', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'VenkataNagaSai Apurupa', 'Initials': 'VA', 'LastName': 'Amperayani', 'Affiliation': 'Department of Electrical Engineering, University of Texas at Tyler, Tyler, TX.'}, {'ForeName': 'Premananda', 'Initials': 'P', 'LastName': 'Indic', 'Affiliation': 'Department of Electrical Engineering, University of Texas at Tyler, Tyler, TX.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2018.03.010']
775,31538599,Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep?,"STUDY OBJECTIVES


The safety profile of the dual orexin receptor antagonists (DORAs) are currently unknown with regard to nocturnal responsivity among people with insomnia. We compared the auditory awakening thresholds (AATs) of the DORA suvorexant (10 and 20 mg) versus placebo in 12 individuals with DSM-5 insomnia.
METHODS


The study used a double-blind, placebo-controlled, three-way crossover design. Participants were randomly assigned to a treatment sequence that included placebo, suvorexant 10 mg, and suvorexant 20 mg. At the time of maximum drug concentration, auditory tones were played during stable stage N2 sleep. Tones increased by 5-decibel (db) increments until the participant awakened. The db at awakening was recorded as the AAT and compared between conditions. The proportion of awakenings higher than 85 db was also compared between conditions. Finally, sensitivity analyses were also conducted using surrounding thresholds (80 db and 90 db).
RESULTS


The mean AAT did not differ significantly between either dose of suvorexant compared to placebo. Moreover, the proportions of individuals who remained asleep at the AAT 85 db cutoff did not differ across conditions. In addition, wake after sleep onset decreased and total sleep time increased in the suvorexant 20 mg condition compared to placebo.
CONCLUSIONS


Suvorexant (10 and 20 mg) preserved the ability to respond to nocturnal stimuli, whereas the 20-mg dose improved the sleep of people with insomnia. This suggests that DORAs such as suvorexant can effectively treat insomnia while allowing patients to awaken to nocturnal stimuli in the environment.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Title: A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs; Identifier NCT03312517; URL: https://clinicaltrials.gov/ct2/show/NCT03312517.
CITATION


Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, SinghM, Tonnu CV, Fellman-Couture C. Can the orexin antagonist suvorexant preserve the ability to awaken to auditory stimuli while improving sleep? J Clin Sleep Med. 2019;15(9):1285-1291.",2019,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"['people with insomnia', '12 individuals with DSM-5 insomnia', 'Non-elderly Insomniacs']","['auditory awakening thresholds (AATs) of the DORA suvorexant', 'Belsomra 10 mg and 20 mg to Placebo', 'placebo, suvorexant 10 mg, and suvorexant 20 mg', 'placebo', 'dual orexin receptor antagonists (DORAs']","['total sleep time', 'mean AAT', 'sleep of people with insomnia', 'proportion of awakenings higher', 'Ability to Awaken to Auditory Stimuli']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C3854974', 'cui_str': 'Belsomra'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3854969', 'cui_str': 'suvorexant 10 MG'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus, function (observable entity)'}]",,0.0638037,The mean AAT did not differ significantly between either dose of suvorexant compared to placebo.,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Kieulinh Michelle', 'Initials': 'KM', 'LastName': 'Tran', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Atkinson', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Meeta', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christine V', 'Initials': 'CV', 'LastName': 'Tonnu', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7920']
776,31538602,CPAP and Health-Related Quality of Life in Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial.,"STUDY OBJECTIVES


To determine the effect of continuous positive airway pressure (CPAP) treatment on health-related quality of life (HRQoL) in adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA).
METHODS


This was a secondary outcome analysis of the RICCADSA trial, conducted in Sweden between 2005 and 2013. Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI] ≥ 15 events/h; Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires at baseline and after 12 months were included. Patients were randomized to CPAP (n = 102) or no CPAP (n = 104). The primary outcome was the between-group difference in absolute change in the SF-36 components. Within-group changes as well as variables associated with absolute change in the domains in the entire population were also tested.
RESULTS


Mean SF-36 scores were similar at baseline, ranging from 44.9 ± 9.6 to 92.2 ± 15.8 in various domains, and between-group changes from baseline were not statistically significant at 1 year. There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group. The change in Physical Component Summary (PCS) was determined by female sex (beta coefficient -0.19, 95% confidence interval [CI] -7.25 to -0.98, P = .010), baseline AHI (beta coefficient -0.19, 95% CI -0.21 to -0.03, P = .009), CPAP use (h/night) (beta coefficient -0.16, 95% CI -0.93 to -0.06, P = .028), and acute myocardial infarction at baseline (beta coefficient 0.18, 95% CI 0.59 to 5.19, P = .014). Determinants of the change in MCS from baseline were change in the ESS score (beta coefficient -0.14, 95% CI -0.87 to -0.01, P = .054) and change in the Zung Self-rated Depression Scale scores (beta coefficient -0.33, 95% CI -0.58 to -0.24, P < .001).
CONCLUSIONS


Assignment to CPAP treatment compared to no CPAP had no significant effect on HRQoL as measured by the SF-36 in adults with CAD and nonsleepy OSA. Although several components of the SF-36 scores were improved within the CPAP group, CPAP use was associated with a decrease in PCS. The improvement in MCS was determined by the improvement in daytime sleepiness and depressive mood.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT00519597.
CITATION


Wallström S, Balcan B, Thunström E, Wolf A, Peker Y. CPAP and health-related quality of life in adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial. J Clin Sleep Med. 2019;15(9):1311-1320.",2019,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","['Adults with CAD, nonsleepy OSA (apnea-hypopnea index [AHI', 'adults with coronary artery disease and nonsleepy obstructive sleep apnea in the RICCADSA trial', 'Adults With Coronary Artery Disease and Nonsleepy Obstructive Sleep Apnea in the RICCADSA Trial', 'adults with CAD and nonsleepy OSA', 'adults with coronary artery disease (CAD) and nonsleepy obstructive sleep apnea (OSA']","['no CPAP', 'continuous positive airway pressure (CPAP', 'CPAP']","['CPAP and Health-Related Quality of Life', 'beta coefficient', 'MCS', 'baseline AHI (beta coefficient', 'HRQoL', 'ESS score', 'Zung Self-rated Depression Scale scores', 'Mean SF-36 scores', 'SF-36 scores', 'health-related quality of life (HRQoL', 'CPAP use (h/night) ', ' Epworth Sleepiness Scale [ESS] score < 10) and complete Short-Form (SF)-36 questionnaires', 'Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS', 'PCS', 'change in Physical Component Summary (PCS', 'Bodily pain and General health scores', 'acute myocardial infarction', 'daytime sleepiness and depressive mood', 'absolute change in the SF-36 components']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4273947', 'cui_str': 'Zung self rating depression scale score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",,0.224914,"There was a significant increase in Role physical, Vitality, Role emotional, Mental health and Mental Component Summary (MCS), and a decrease in Bodily pain and General health scores in the CPAP group.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallström', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Balcan', 'Affiliation': 'Department of Pulmonary Medicine, Marmara University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunström', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Peker', 'Affiliation': 'Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7926']
777,29791259,"A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation.","BACKGROUND


Whether financial incentives, pharmacologic therapies, and electronic cigarettes (e-cigarettes) promote smoking cessation among unselected smokers is unknown.
METHODS


We randomly assigned smokers employed by 54 companies to one of four smoking-cessation interventions or to usual care. Usual care consisted of access to information regarding the benefits of smoking cessation and to a motivational text-messaging service. The four interventions consisted of usual care plus one of the following: free cessation aids (nicotine-replacement therapy or pharmacotherapy, with e-cigarettes if standard therapies failed); free e-cigarettes, without a requirement that standard therapies had been tried; free cessation aids plus $600 in rewards for sustained abstinence; or free cessation aids plus $600 in redeemable funds, deposited in a separate account for each participant, with money removed from the account if cessation milestones were not met. The primary outcome was sustained smoking abstinence for 6 months after the target quit date.
RESULTS


Among 6131 smokers who were invited to enroll, 125 opted out and 6006 underwent randomization. Sustained abstinence rates through 6 months were 0.1% in the usual-care group, 0.5% in the free cessation aids group, 1.0% in the free e-cigarettes group, 2.0% in the rewards group, and 2.9% in the redeemable deposit group. With respect to sustained abstinence rates, redeemable deposits and rewards were superior to free cessation aids (P<0.001 and P=0.006, respectively, with significance levels adjusted for multiple comparisons). Redeemable deposits were superior to free e-cigarettes (P=0.008). Free e-cigarettes were not superior to usual care (P=0.20) or to free cessation aids (P=0.43). Among the 1191 employees (19.8%) who actively participated in the trial (the ""engaged"" cohort), sustained abstinence rates were four to six times as high as those among participants who did not actively engage in the trial, with similar relative effectiveness.
CONCLUSIONS


In this pragmatic trial of smoking cessation, financial incentives added to free cessation aids resulted in a higher rate of sustained smoking abstinence than free cessation aids alone. Among smokers who received usual care (information and motivational text messages), the addition of free cessation aids or e-cigarettes did not provide a benefit. (Funded by the Vitality Institute; ClinicalTrials.gov number, NCT02328794 .).",2018,Free e-cigarettes were not superior to usual care (P=0.20) or to free cessation aids (P=0.43).,"['We randomly assigned smokers employed by 54 companies to one of four', '6131 smokers who were invited to enroll, 125 opted out and 6006 underwent randomization', '1191 employees (19.8%) who actively participated in the trial (the ""engaged"" cohort']","['usual care (information and motivational text messages', 'usual care plus one of the following: free cessation aids (nicotine-replacement therapy or pharmacotherapy, with e-cigarettes if standard therapies failed); free e-cigarettes, without a requirement that standard therapies had been tried; free cessation aids plus $600 in rewards for sustained abstinence; or free cessation aids plus $600 in redeemable funds', 'smoking-cessation interventions or to usual care']","['sustained smoking abstinence', 'sustained smoking abstinence for 6 months after the target quit date', 'Sustained abstinence rates', 'sustained abstinence rates']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]",6131.0,0.0981319,Free e-cigarettes were not superior to usual care (P=0.20) or to free cessation aids (P=0.43).,"[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Harhay', 'Affiliation': 'From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Saulsgiver', 'Affiliation': 'From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brophy', 'Affiliation': 'From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'From the Departments of Medicine (S.D.H., K.G.V.), Medical Ethics and Health Policy (S.D.H., K.G.V.), and Biostatistics, Epidemiology, and Informatics (S.D.H., M.O.H., K.S.), University of Pennsylvania Perelman School of Medicine, the Center for Health Incentives and Behavioral Economics at the Leonard Davis Institute of Health Economics (S.D.H., M.O.H., K.S., A.B.T., K.G.V.), the Palliative and Advanced Illness Research Center (S.D.H., M.O.H.), and the Department of Health Care Management, Wharton School (K.G.V.), University of Pennsylvania, and the Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center (M.O.H., K.G.V.) - all in Philadelphia; and the Vitality Institute (C.B.) and the Division of Biostatistics, New York University Langone Medical Center (A.B.T.) - both in New York.'}]",The New England journal of medicine,['10.1056/NEJMsa1715757']
778,29882722,"Effect of a 6-Week Weighted Baseball Throwing Program on Pitch Velocity, Pitching Arm Biomechanics, Passive Range of Motion, and Injury Rates.","BACKGROUND


Emphasis on enhancing baseball pitch velocity has become popular, especially through weighted-ball throwing. However, little is known about the physical effects or safety of these programs. The purpose of this study was to examine the effects of training with weighted baseballs on pitch velocity, passive range of motion (PROM), muscle strength, elbow torque, and injury rates.
HYPOTHESIS


A 6-week weighted ball training program would result in a change in pitching biomechanical and physical characteristics.
STUDY DESIGN


Randomized controlled trial.
LEVEL OF EVIDENCE


Level 1.
METHODS


During the baseball offseason, 38 healthy baseball pitchers were randomized into a control group and an experimental group. Pitch velocity, shoulder and elbow PROM, shoulder strength, elbow varus torque, and shoulder internal rotation velocity were measured in both groups. The experimental group then performed a 6-week weighted ball throwing program 3 times per week using balls ranging from 2 to 32 ounces while the control group only used a 5-ounce regulation baseball. Both groups performed a strength training program. Measurements were then repeated after the 6-week period. Injuries were tracked over the 6-week training program and the subsequent baseball season. The effect of training with a weighted ball program was assessed using 2-way repeated-measures analysis of variance at an a priori significance level of P < 0.05.
RESULTS


Mean age, height, mass, and pretesting throwing velocity were 15.3 ± 1.2 years (range, 13-18 years), 1.73 ± 0.28 m, 68.3 ± 11 kg, and 30.3 ± 0.7 m/s, respectively. Pitch velocity showed a statistically significant increase (3.3%) in the experimental group ( P < 0.001). There was a statistically significant increase of 4.3° of shoulder external rotation in the experimental group. The overall injury rate was 24% in the experimental group. Four participants in the experimental group suffered elbow injuries, 2 during the training program and 2 in the season after training. No pitchers in the control group were injured at any time during the study.
CONCLUSION


Performing a 6-week weighted ball throwing program increased pitch velocity. However, the program resulted in increased shoulder external rotation PROM and increased injury rate.
CLINICAL RELEVANCE


Although weighted-ball training may increase pitch velocity, caution is warranted because of the notable increase in injuries and physical changes observed in this cohort.",2018,Pitch velocity showed a statistically significant increase (3.3%) in the experimental group ( P < 0.001).,"['38 healthy baseball pitchers', 'Mean age, height, mass, and pretesting throwing velocity were 15.3 ± 1.2 years (range, 13-18 years), 1.73 ± 0.28 m, 68.3 ± 11 kg, and 30.3 ± 0.7 m/s, respectively']","['strength training program', '6-Week Weighted Baseball Throwing Program']","['pitch velocity, passive range of motion (PROM), muscle strength, elbow torque, and injury rates', 'Pitch Velocity, Pitching Arm Biomechanics, Passive Range of Motion, and Injury Rates', 'shoulder external rotation', 'Pitch velocity', 'shoulder external rotation PROM and increased injury rate', 'pitch velocity', 'Pitch velocity, shoulder and elbow PROM, shoulder strength, elbow varus torque, and shoulder internal rotation velocity', 'elbow injuries', 'overall injury rate']","[{'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517445', 'cui_str': '0.28 (qualifier value)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",38.0,0.0255703,Pitch velocity showed a statistically significant increase (3.3%) in the experimental group ( P < 0.001).,"[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Reinold', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Leonard C', 'Initials': 'LC', 'LastName': 'Macrina', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Fleisig', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Aune', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Andrews Sports Medicine and Orthopaedic Center, Birmingham, Alabama.'}]",Sports health,['10.1177/1941738118779909']
779,31579533,Patellofemoral Arthroplasty.,"Background


The first report of patellofemoral arthroplasty (PFA) was published in 1979 1 . Reviews in 2005 and 2007 2,3  called for studies comparing PFA with total knee arthroplasty (TKA) for isolated patellofemoral osteoarthritis. A blinded randomized controlled trial (RCT) was initiated in 2007 for this purpose, and the first report with 2-year results was awarded the Mark Coventry Award of the Knee Society in 2017 4 . It was found that (1) patients recover more quickly from PFA than from TKA; (2) during the first 2 years after surgery, PFA-treated patients have better average knee function than TKA-treated patients; and (3) PFA-treated patients regain their preoperative range of movement within the first postoperative year whereas TKA-treated patients do not regain it within the first 2 years 4 .
Description


There are general principles that are common to all brands of PFA implants. These include (1) an indication based on bone-on-bone contact in the patellofemoral joint with a preserved tibiofemoral joint; (2) replacing all surfaces of the patellofemoral joint, with metal on the femoral side and polyethylene on the patellar side; (3) ensuring a smooth transition from normal articular cartilage to the trochlear component; and (4) creating normal patellofemoral tracking.
Alternatives


The primary treatment of any degenerative condition should be nonoperative, but when such measures are insufficient surgical treatment may be indicated. Many procedures have been suggested for relieving patellofemoral pain, but if there is bone-on-bone contact in the patellofemoral joint, the only current surgical option (except for experimental treatments) is joint replacement-i.e., either PFA or TKA.
Rationale


Our general principle for joint replacement of the knee is to replace only the affected compartment if unicompartmental changes are found. If ≥2 compartments are affected, we perform TKA. This principle is challenged both by proponents of performing TKA in all cases of knee osteoarthritis and by proponents of bicompartmental knee replacement for 2-compartment disease. The 2-year results of our blinded RCT comparing PFA and TKA 4  support our current practice of PFA. In our practice, we have found PFA to be a rewarding procedure when the correct indications are used. PFA is likely to remain a fairly rare procedure, but any knee arthroplasty center should be able to offer it.",2019,"It was found that (1) patients recover more quickly from PFA than from TKA; (2) during the first 2 years after surgery, PFA-treated patients have better average knee function than TKA-treated patients; and (3) PFA-treated patients regain their preoperative range of movement within the first postoperative year whereas TKA-treated patients do not regain it within the first 2 years 4 .
",[],"['PFA', 'PFA with total knee arthroplasty (TKA', 'bone-on-bone contact in the patellofemoral joint with a preserved tibiofemoral joint; (2) replacing all surfaces of the patellofemoral joint, with metal on the femoral side and polyethylene on the patellar side; (3) ensuring a smooth transition from normal articular cartilage to the trochlear component; and (4) creating normal patellofemoral tracking', 'patellofemoral arthroplasty (PFA']","['average knee function', 'Patellofemoral Arthroplasty']",[],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0447801', 'cui_str': 'Patellofemoral Articulation'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0007303', 'cui_str': 'Cartilage, Articular'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]",,0.026381,"It was found that (1) patients recover more quickly from PFA than from TKA; (2) during the first 2 years after surgery, PFA-treated patients have better average knee function than TKA-treated patients; and (3) PFA-treated patients regain their preoperative range of movement within the first postoperative year whereas TKA-treated patients do not regain it within the first 2 years 4 .
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Odgaard', 'Affiliation': 'Department of Orthopedics, Copenhagen University Hospital Herlev-Gentofte, Hellerup, Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Eldridge', 'Affiliation': 'Avon Orthopedic Centre, Bristol, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madsen', 'Affiliation': 'Department of Orthopedics, Aarhus University Hospital, Aarhus, Denmark.'}]",JBJS essential surgical techniques,['10.2106/JBJS.ST.18.00094']
780,31538590,Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep in Toddlers Born Preterm: Secondary Analysis of a Randomized Clinical Trial.,"STUDY OBJECTIVES


This secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children's caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect.
METHODS


Omega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted.
RESULTS


Eighty-one percent (n tx  = 156; n placebo  = 150) of children had 180-day trial outcome data; 68% (n tx  = 134; n placebo  = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo.
CONCLUSIONS


Although there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Identifier: NCT01576783.
CITATION


Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197-1208.",2019,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","['Male children', 'toddlers born preterm', 'Toddlers Born Preterm', ""Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks' gestation"", ""children's caregiver-reported sleep"", 'Eighty-one percent (n tx  = 156; n']","['DHA+AA supplementation', 'docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation', 'Docosahexaenoic Acid and Arachidonic Acid Supplementation and Sleep', 'placebo', 'DHA + 200 mg AA supplementation or placebo', 'Docosahexaenoic acid and arachidonic acid supplementation']","['total sleep change', ""sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child's sleep (Brief Infant Sleep Questionnaire"", 'child sex, birth weight, and caregiver depressive symptomatology']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",,0.812072,"Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P","[{'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Pelak', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': 'Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio.""}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7902']
781,31538598,Eye-Blink Parameters Detect On-Road Track-Driving Impairment Following Severe Sleep Deprivation.,"STUDY OBJECTIVES


Drowsiness leads to 20% of fatal road crashes, while inability to assess drowsiness has hampered drowsiness interventions. This study examined the accuracy of eye-blink parameters for detecting drowsiness related driving impairment in real time.
METHODS


Twelve participants undertook two sessions of 2-hour track-driving in an instrumented vehicle following a normal night's sleep or 32 to 34 hours of extended wake in a randomized crossover design. Eye-blink parameters and lane excursion events were monitored continuously.
RESULTS


Sleep deprivation increased the rates of out-of-lane driving events and early drive terminations. Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score) were also increased following sleep deprivation. A time-on-task (drive duration) effect was evident for out-of-lane events rate and most eye-blink parameters after sleep deprivation. The JDS demonstrated the strongest association with the odds of out-of-lane events in the same minute, whereas measures of blink duration and prolonged eye closure were stronger indicators of risk for out-of-lane events over longer periods of 5 minutes and 15 minutes, respectively. Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
CONCLUSIONS


Eyelid closure parameters are useful tools for monitoring and predicting drowsiness-related driving impairment (out-of-lane events) that could be utilized for monitoring drowsiness and assessing the efficacy of drowsiness interventions.
CLINICAL TRIAL REGISTRATION


This study is registered with the Australian New Zealand Clinical Trial Registry (ANCTR), http://www.anzctr.org.au/TrialSearch.aspx ACTRN12612000102875.
CITATION


Shekari Soleimanloo S, Wilkinson VE, Cori JM,Westlake J, Stevens B, Downey LA, Shiferaw BA, Rajaratnam SMW, Howard ME. Eye-blink parameters detect on-road track-driving impairment following severe sleep deprivation. J Clin Sleep Med. 2019;15(9):1271-1284.",2019,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
",['severe sleep deprivation'],"[""2-hour track-driving in an instrumented vehicle following a normal night's sleep""]","['rates of out-of-lane driving events and early drive terminations', 'blink duration and prolonged eye closure', 'A time-on-task (drive duration) effect', 'Eye-blink parameters and lane excursion events', 'Eye-Blink Parameters Detect', ""Episodes of prolonged eyelid closures, blink duration, the ratio of amplitude to velocity of eyelid closure, and John's Drowsiness Score (JDS, a composite score""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}]","[{'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1269837', 'cui_str': 'Surgical closure of eye structure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1293738', 'cui_str': 'Eyelid closure'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",12.0,0.019793,"Eye-blink parameters also achieved moderate accuracies (specificities from 70.12% to 84.15% at a sensitivity of 50%) for detecting out-of-lane events in the same minute, with stronger associations over longer timeframes of 5 minutes to 15 minutes.
","[{'ForeName': 'Shamsi', 'Initials': 'S', 'LastName': 'Shekari Soleimanloo', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Wilkinson', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Cori', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Westlake', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stevens', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Luke A', 'Initials': 'LA', 'LastName': 'Downey', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Brook A', 'Initials': 'BA', 'LastName': 'Shiferaw', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}, {'ForeName': 'Shantha M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences, Monash University, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Howard', 'Affiliation': 'Institute for Breathing and Sleep, Department of Respiratory and Sleep Medicine, Austin Health, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.7918']
782,31347100,Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes.,"INTRODUCTION


Type 2 diabetic patients suffering from severe hyperglycemia are often assigned a regimen involving multiple daily injections (MDI) of insulin. If the glucose toxicity resolves, the regimen can potentially be simplified, but there are no guidelines for this, and many patients are left on the MDI regimen. We aimed to prospectively examine the safety and efficacy of switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c ≤ 7.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD).
METHODS


62 adults with type 2 diabetes (baseline age 64.06 ± 10.24 years, HbA 1c  6.42 ± 0.68%, BMI 33.53 ± 6.90 kg/m 2 , body weight 93.81 ± 19.26 kg, TDD 43.31 ± 10.99 IU/day, insulin requirement 0.47 ± 0.13 IU/kg, duration of diabetes 10.84 ± 7.50 years, mean ± SD) treated with MDI ± metformin were enrolled in our study. Previous insulins were stopped and once-daily IDegLira was started. IDegLira was titrated by the patients to achieve a self-measured pre-breakfast blood glucose concentration of < 6 mmol/L.
RESULTS


After a mean follow-up period of 99.2 days, mean HbA 1c  had decreased by 0.30% to 6.12 ± 0.65% (p < 0.0001), body weight had decreased by 3.11 kg to 90.70 ± 19.12 kg (p < 0.0001), and BMI had reduced to 32.39 ± 6.71 kg/m 2  (p < 0.0001). After 3 months of treatment, the mean dose of IDegLira was 20.76 ± 6.60 units and the mean insulin requirement had decreased to 0.23 ± 0.08 IU/kg. IDegLira ± metformin combination therapy was found to be safe and generally well tolerated. During the month before the baseline visit, 28 patients (45%) had at least one episode of documented or symptomatic hypoglycemia, while only 6 (9.67%) patients reported a total of 13 documented episodes during the follow-up.
CONCLUSION


In everyday clinical practice, switching from low-dose MDI to IDegLira in patients with well-controlled type 2 diabetes is safe, may result in weight loss and similar or better glycemic control, and substantially reduces the insulin requirement. Simplifying complex treatment regimens decreases treatment burden and may improve adherence to therapy.
CLINICAL TRIAL NUMBER


NCT04020445.",2019,IDegLira ± metformin combination therapy was found to be safe and generally well tolerated.,"['relatively well controlled (HbA1c\u2009≤\u20097.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD', 'patients with well-controlled type 2 diabetes', 'diabetic patients suffering from severe hyperglycemia', 'Type 2 Diabetes', '62 adults with type 2 diabetes (baseline age 64.06\u2009±\u200910.24\xa0years, HbA 1c  6.42\u2009±\u20090.68%, BMI 33.53\u2009±\u20096.90\xa0kg/m 2 , body weight 93.81\u2009±\u200919.26\xa0kg, TDD 43.31\u2009±\u200910.99\xa0IU/day, insulin requirement 0.47\u2009±\u20090.13\xa0IU/kg, duration of diabetes 10.84\u2009±\u20097.50\xa0years, mean\u2009±\u2009SD) treated with MDI\u2009±']","['metformin combination therapy', 'metformin', 'switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide']","['IDegLira', 'mean dose of IDegLira', 'symptomatic hypoglycemia', 'mean insulin requirement', 'BMI', 'safe and generally well tolerated', 'mean HbA 1c', 'body weight', 'safety and efficacy']","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0183841', 'cui_str': 'Telecommunications Devices for the Deaf'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517473', 'cui_str': '0.68'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C4517428', 'cui_str': '0.13 (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}]","[{'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",62.0,0.0433742,IDegLira ± metformin combination therapy was found to be safe and generally well tolerated.,"[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Taybani', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary. taybanizoltan@gmail.com.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Bótyik', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary.'}, {'ForeName': 'Mónika', 'Initials': 'M', 'LastName': 'Katkó', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Nagyerdei krt. 98, Debrecen, 4032, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Gyimesi', 'Affiliation': '1st Department of Endocrinology, Dr. Réthy Pál Member Hospital, Békés County Central Hospital, Gyulai street 18, Békéscsaba, 5600, Hungary.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Várkonyi', 'Affiliation': '1st Department of Internal Medicine, University of Szeged, Korányi fasor 8, Szeged, 6720, Hungary.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-0673-8']
783,31876907,Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial.,"AIMS


To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence.
METHODS AND RESULTS


This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm.
CONCLUSION


In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected.
CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER


NCT01813435.",2020,No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952).,"['treated patients undergoing', 'patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD']","['percutaneous coronary intervention', 'ticagrelor', 'aspirin monotherapy', 'ticagrelor monotherapy']","['2-year clinical outcomes', 'COPD and dyspnoea AE', '2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction', 'dyspnoea']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",2101.0,0.320772,No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952).,"[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Spitzer', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Plante', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernández Antolin', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Jambrik', 'Affiliation': 'Békés Megyei Pándy Kálmán Kórház County Hospital, Gyula, Hungary.'}, {'ForeName': 'Valeri', 'Initials': 'V', 'LastName': 'Gelev', 'Affiliation': 'Tokuda Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Cardiologie Clinique Valmy Hopital Prive Dijon Bourgogne HPDB Dijon, Dijon, France.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Konteva', 'Affiliation': 'Heart Centre ""Pontica"", Burgas, Bulgaria.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen, Caen, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Morelle', 'Affiliation': 'Clinique St. Martin, Caen, France.'}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Cardiovascular Science, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz052']
784,32016122,Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial.,"Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients' self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) ( X   2 (1) = 0.58;  p  = 0.45), and the number of patients who logged on at least once (platform users) ( X   2 (1) = 0.46;  p  = 0.50). In addition, no differences were found between the groups in the type of users-patients who logged on twice or more (active users) or patients who logged on once (nonactive users) ( X   2 (1) = 0.56;  p  = 0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.",2020,"No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) ( X   2 (1) = 0.58;  p  = 0.45), and the number of patients who logged on at least once (platform users) ( X   2 (1) = 0.46;  p  = 0.50).","['patients with T2DM received either', 'Patients with Type 2 Diabetes in Primary Care', 'patients with T2DM', '203 patients', 'patients with T2DM treated by primary care providers in the Netherlands', 'patients with type 2 diabetes (T2DM) in managing their health']","['PRISMA with usual care or usual care only', 'Proactive Interdisciplinary Self-Management (PRISMA) Program', 'Proactive Interdisciplinary Self-Management (PRISMA) program']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0138404', 'cui_str': 'prisma'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0306319,"No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) ( X   2 (1) = 0.58;  p  = 0.45), and the number of patients who logged on at least once (platform users) ( X   2 (1) = 0.46;  p  = 0.50).","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'du Pon', 'Affiliation': 'Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, PO Box 12011, 3501 AA Utrecht, Netherlands.'}, {'ForeName': 'Nanne', 'Initials': 'N', 'LastName': 'Kleefstra', 'Affiliation': 'Medical Research Group, Langerhans, Ommen, 7731 MX, Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Cleveringa', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, 3584 CX, Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'van Dooren', 'Affiliation': 'Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, PO Box 12011, 3501 AA Utrecht, Netherlands.'}, {'ForeName': 'Eibert R', 'Initials': 'ER', 'LastName': 'Heerdink', 'Affiliation': 'Research Group Process Innovations in Pharmaceutical Care, Utrecht University of Applied Sciences, PO Box 12011, 3501 AA Utrecht, Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dulmen', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, 3513 CR, Netherlands.'}]",Journal of diabetes research,['10.1155/2020/5013142']
785,29589111,Effects of resistance training on MRI-derived epicardial fat volume and arterial stiffness in women with obesity: a randomized pilot study.,"AIM


To date, few studies have analyzed the effects of exercise on cardiac adipose tissue. Overall, exercise programs did not meet the recommendations for significant weight loss, the utilization of resistance training was minimal, and the conclusions derived from these studies have diminished exercise as a strategy for cardiac fat loss.
PURPOSE


The objective of this pilot study was to analyze the effects of 3-week high-intensity, moderate-volume muscular endurance resistance training (RT) on cardiac fat and arterial stiffness.
METHODS


A total of 11 young females with obesity, BMI = 34.13 (± 3.16) kg/m 2  (n = 5 control, n = 6 intervention) completed the study. Absolute strength was assessed using one repetition maximum test (1RM) for bench press (BP) and leg press (LP), and relative strength was calculated using body weight (BW) as BP-to-BW and LP-to-BW ratio. Magnetic resonance was used to quantify epicardial and paracardial adipose tissue (EAT and PAT) volume, and applanation tonometry was used to assess arterial stiffness by estimating pulse wave velocity (PWV).
RESULTS


EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group. In addition, strength was significantly improved, including BP (p = 0.003), LP (p = 0.001), BP-to-BW ratio (p = 0.001), and LP-to-BW ratio (p = 0.002), while no changes were found in PWV.
CONCLUSIONS


High-intensity, moderate-volume RT, designed to enhance muscular endurance following the recommendations reduces EAT and PAT volumes, improves physical fitness in females with obesity, and has no negative effects on arterial stiffness.",2018,"RESULTS


EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group.","['females with obesity', '11 young females with obesity, BMI\u2009=\u200934.13 (±\u20093.16) kg/m 2  (n\u2009=\u20095 control, n\u2009=\u20096 intervention) completed the study', 'women with obesity']","['resistance training', '3-week high-intensity, moderate-volume muscular endurance resistance training (RT', 'Magnetic resonance']","['cardiac fat and arterial stiffness', 'physical fitness', 'Absolute strength', 'interaction effects', 'repetition maximum test (1RM) for bench press (BP) and leg press (LP), and relative strength', 'BP', 'epicardial and paracardial adipose tissue (EAT and PAT) volume, and applanation tonometry', 'LP', 'BP-to-BW ratio']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",11.0,0.0316204,"RESULTS


EAT and PAT volumes (ml) showed significant interaction effects (p = 0.037 and p = 0.031), and very large changes (d > 1) of EAT (p = 0.006) and PAT (p = 0.036) in the intervention group.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fernandez-del-Valle', 'Affiliation': 'Department of Applied Health, Southern Illinois University Edwardsville, Vadalabene Center, Edwardsville, IL, 62026, USA. marfern@siue.edu.'}, {'ForeName': 'Joaquin U', 'Initials': 'JU', 'LastName': 'Gonzales', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, 3204 Main St, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kloiber', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, 3204 Main St, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Sunanda', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Department of Electrical and Computer Engineering, Texas Tech University, 1012 Boston Ave, Lubbock, TX, 79409, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Klingensmith', 'Affiliation': 'Department of Electrical and Computer Engineering, Southern Illinois University Edwardsville, 30 Circle Drive, Edwardsville, IL, 62026, USA.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, 3601 4th Street, Lubbock, TX, 79430, USA.'}]",European journal of applied physiology,['10.1007/s00421-018-3852-9']
786,31635815,"Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.","BACKGROUND


Mirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.
OBJECTIVE


To summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.
DESIGN, SETTING, AND PARTICIPANTS


Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.
INTERVENTION


Mirabegron: 25 and 50mg; antimuscarinics: solifenacin (2.5, 5, and 10mg) and tolterodine extended release (4mg).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (<65 vs ≥65yr and <75 vs ≥75yr) and sex were assessed. Solifenacin 2.5 and 10mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).
RESULTS AND LIMITATIONS


Baseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24h by age (<65 vs ≥65yr), nocturia by age (<65 vs ≥65yr and <75 vs ≥75yr), and urgency episodes by previous OAB medication.
CONCLUSIONS


Data from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.
PATIENT SUMMARY


Overactive bladder is a complex of symptoms including a compelling desire to pass urine that leads to increased frequency, which may lead to a degree of incontinence if you do not reach the toilet in time and may wake you from sleep. We pooled data from 10 different studies of mirabegron in patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women. No new safety concerns were identified, and mirabegron improved the symptoms of overactive bladder.",2020,"Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups.","['Pooled data analysed from 10 phase 2-4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug', 'adults of different age groups and sexes', 'patients with overactive bladder symptoms, and looked at the effect in the total number of patients who received the treatment, as well as in different age groups and between men and women', 'Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or']","['Placebo', 'antimuscarinics: solifenacin', 'Mirabegron', 'placebo', 'tolterodine extended release (4mg', 'Solifenacin']","['symptoms of overactive bladder', 'efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes', 'Safety', 'nocturia', 'Baseline hypertension and diabetes', 'Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age ']","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0595947', 'cui_str': 'Extrinsic (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",,0.124115,"Improvements in efficacy (mean number of incontinence episodes/24h, micturitions/24h, urgency episodes/24h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Chapple', 'Affiliation': 'Royal Hallamshire Hospital, Sheffield, UK. Electronic address: c.r.chapple@sheffield.ac.uk.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cruz', 'Affiliation': 'Department of Urology, Faculty of Medicine, Hospital S João, Porto, Portugal; I3S Institute, Porto, Portugal.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cardozo', 'Affiliation': ""Department of Urogynaecology, King's College Hospital, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Urology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Astellas Pharma Europe Ltd., Chertsey, Surrey, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stoelzel', 'Affiliation': 'Department of Data Science, Astellas Pharma Europe, Leiden, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Global Medical Affairs, Astellas Pharma, Chertsey, UK.'}]",European urology,['10.1016/j.eururo.2019.09.024']
787,29530423,Effectiveness of a community-based educational programme in reducing the cumulative incidence and prevalence of human Taenia solium cysticercosis in Burkina Faso in 2011-14 (EFECAB): a cluster-randomised controlled trial.,"BACKGROUND


The effectiveness of drug-free interventions in controlling human cysticercosis is not well known. We aimed to estimate the effectiveness of a community-based educational intervention in reducing the frequency of human cysticercosis in Burkina Faso.
METHODS


We did a cluster-randomised controlled trial between 2011 and 2014. 60 eligible villages from three provinces (Boulkiemdé, Sanguié, and Nayala) were randomly allocated to the intervention or control group. Villages raising pigs, that were not a regional capital or located on a main road, that were more than 20 km from Ouagadougou or 5 km from one another, were eligible. In each village, 60 participants were asked for blood samples at baseline, 18 months later (before randomisation), and 18 months after randomisation. Villages were block randomised (1:1) by pig-raising department immediately after the pre-randomisation visit. The intervention aimed to improve knowledge of Taenia solium transmission and control through screening and structured discussion of a 52-min movie, and to increase community self-efficacy through a Self-esteem, Associative strengths, Resourcefulness, Action planning, Responsibility (SARAR) approach via the Participatory Hygiene and Sanitation Transformation (PHAST) model. The primary outcome was active cysticercosis, defined as the presence of circulating antigens detected by use of B158/B60 ELISA. Effectiveness measured at the village level was estimated by use of three Bayesian hierarchical models. This study is registered with ClinicalTrials.gov, number NCT0309339.
FINDINGS


Two villages in the same randomisation block were excluded, resulting in a final sample size of 58 villages. Overall, the intervention tended towards a decrease in the cumulative incidence of active cysticercosis from baseline to after randomisation (adjusted cumulative incidence ratio 0·65, 95% Bayesian credible interval [95% CrI] 0·39-1·05) and a decrease in active cysticercosis prevalence from baseline to after randomisation (adjusted prevalence proportion ratio 0·84; 95% CrI 0·59-1·18). The intervention was shown to be effective in Nayala and Sanguié but not in Boulkiemdé.
INTERPRETATION


Community-engaged participatory interventions can be effective at reducing the incidence and prevalence of cysticercosis in some low-resource settings.
FUNDING


US National Institutes of Health (National Institute of Neurological Disorders and Stroke, Fogarty International Center, and National Institute of General Medical Sciences).",2018,"Overall, the intervention tended towards a decrease in the cumulative incidence of active cysticercosis from baseline to after randomisation (adjusted cumulative incidence ratio 0·65, 95% Bayesian credible interval [95% CrI] 0·39-1·05) and a decrease in active cysticercosis prevalence from baseline to after randomisation (adjusted prevalence proportion ratio 0·84; 95% CrI 0·59-1·18).","['Villages raising pigs, that were not a regional capital or located on a main road, that were more than 20 km from Ouagadougou or 5 km from one another, were eligible', '60 eligible villages from three provinces (Boulkiemdé, Sanguié, and Nayala', 'Two villages in the same randomisation block were excluded, resulting in a final sample size of 58 villages', 'human Taenia solium cysticercosis in Burkina Faso in 2011-14 (EFECAB', 'human cysticercosis in Burkina Faso']","['community-based educational programme', 'Self-esteem, Associative strengths, Resourcefulness, Action planning, Responsibility (SARAR) approach via the Participatory Hygiene and Sanitation Transformation (PHAST) model', 'community-based educational intervention']","['active cysticercosis prevalence', 'active cysticercosis, defined as the presence of circulating antigens detected by use of B158/B60 ELISA', 'cumulative incidence of active cysticercosis']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0039251', 'cui_str': 'Tapeworm, Pork'}, {'cui': 'C0010678', 'cui_str': 'Cysticercosis'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0010678', 'cui_str': 'Cysticercosis'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",60.0,0.274977,"Overall, the intervention tended towards a decrease in the cumulative incidence of active cysticercosis from baseline to after randomisation (adjusted cumulative incidence ratio 0·65, 95% Bayesian credible interval [95% CrI] 0·39-1·05) and a decrease in active cysticercosis prevalence from baseline to after randomisation (adjusted prevalence proportion ratio 0·84; 95% CrI 0·59-1·18).","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Carabin', 'Affiliation': 'Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Electronic address: helene-carabin@ouhsc.edu.'}, {'ForeName': 'Athanase', 'Initials': 'A', 'LastName': 'Millogo', 'Affiliation': 'Centre Hospitalier Universitaire Souro Sanou, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Helena A', 'Initials': 'HA', 'LastName': 'Ngowi', 'Affiliation': 'Department of Veterinary Medicine and Public Health, Sokoine University of Agriculture, Chuo Kikuu, Morogoro, Tanzania.'}, {'ForeName': 'Cici', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'Department of Biostatistics, Brown University, Providence, RI, USA; ECD Non-Clinical Statistics, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Dermauw', 'Affiliation': 'Department of Biomedical Sciences, Institute of Tropical Medicine, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Assana Cissé', 'Initials': 'AC', 'LastName': 'Koné', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Sahlu', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, RI, USA; School of Public Health, and Population Studies and Training Center, Brown University, Providence, RI, USA.'}, {'ForeName': 'Alicia L', 'Initials': 'AL', 'LastName': 'Salvator', 'Affiliation': 'Department of Health Promotion Sciences, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Preux', 'Affiliation': 'INSERM, Université de Limoges, and Tropical Neuroepidemiology, Institute of Epidemiology and Tropical Neurology, Limoges, France.'}, {'ForeName': 'Télesphore', 'Initials': 'T', 'LastName': 'Somé', 'Affiliation': ""Société d'Études et de Recherche en Santé Publique (SERSAP), Ouagadougou, Burkina Faso.""}, {'ForeName': 'Zékiba', 'Initials': 'Z', 'LastName': 'Tarnagda', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gabriël', 'Affiliation': 'Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.'}, {'ForeName': 'Rabiou', 'Initials': 'R', 'LastName': 'Cissé', 'Affiliation': 'Université de Ouagadougou, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Jean-Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Cowan', 'Affiliation': 'Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Boncoeur-Martel', 'Affiliation': 'INSERM, Université de Limoges, and Tropical Neuroepidemiology, Institute of Epidemiology and Tropical Neurology, Limoges, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Dorny', 'Affiliation': 'Department of Biomedical Sciences, Institute of Tropical Medicine, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Rasmané', 'Initials': 'R', 'LastName': 'Ganaba', 'Affiliation': ""Agence de Formation de Recherche et d'Expertise en Santé pour l'Afrique (AFRICSanté), Bobo Dioulasso, Burkina Faso.""}]",The Lancet. Global health,['10.1016/S2214-109X(18)30027-5']
788,29489510,Clinicopathologic Significance of Intestinal-type Molecules' Expression and Different EGFR Gene Status in Pulmonary Adenocarcinoma.,"Variant pulmonary adenocarcinoma with intestinal-type molecules shares similar molecular expression with colorectal carcinoma. However, expression of such molecules and their association with survival time with clinicopathologic parameters, such as epidermal growth factor receptor (EGFR) gene status in other types of pulmonary adenocarcinoma, has been rarely demonstrated. Sixty patients with resected pulmonary adenocarcinoma were divided into the enteric differentiation group (I group, n=30) and the usual group (U group, n=30). Immunohistochemical staining was used to assess the expression of carcinoembryonic antigen (CEA), Villin, CK20, and caudal-related homeobox 2 (CDX2). EGFR gene status was examined by Fluorescence Quantitative polymerase chain reaction. Kaplan-Meier survival curve was drawn by GraphPad Prism 5.0 software. The results showed that there was a significant difference between the 2 groups (P<0.05) in the expression of Villin, CK20, and CDX2, whereas the expression of CEA showed no significant difference (P>0.05). Compared with the U group, patients in the I group were mainly female individuals and in clinical stages III to IV, prone to lymph node metastasis (P<0.05). The patients in the I group with CDX2CK20 phenotype (tumor size>5 cm) had a shorter survival time (P<0.05), and EGFR gene status was not associated with median survival time and the expression of CEA, Villin, CK20, and CDX2 (P>0.05). Thus, our research indicates that patients with enteric differentiation have unique clinical characteristics and different prognosis, which may play important roles in diagnosis and choosing therapeutic strategies for pulmonary adenocarcinoma patients in clinical practice.",2019,"Immunohistochemical staining was used to assess the expression of carcinoembryonic antigen (CEA), Villin, CK20, and caudal-related homeobox 2","['pulmonary adenocarcinoma patients in clinical practice', 'Pulmonary Adenocarcinoma', 'patients with enteric differentiation', 'Sixty patients with resected pulmonary adenocarcinoma']",[],"['shorter survival time', 'expression of carcinoembryonic antigen (CEA), Villin, CK20, and caudal-related homeobox 2', 'median survival time and the expression of CEA, Villin, CK20, and CDX2 (P>0.05', 'expression of Villin, CK20, and CDX2', 'Kaplan-Meier survival curve']","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0078238', 'cui_str': 'villin'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0242303', 'cui_str': 'Homeobox Sequence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",60.0,0.0161186,"Immunohistochemical staining was used to assess the expression of carcinoembryonic antigen (CEA), Villin, CK20, and caudal-related homeobox 2","[{'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Departments of *Anesthesiology §Thoracic Surgery, The Second Hospital of Shandong University Departments of †Pathology ‡Thoracic Surgery, Affiliated Hospital of Shandong Academy of Medical Sciences, Shandong Academy of Medical Sciences, Jinan, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'Xiangshan', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}]",Applied immunohistochemistry & molecular morphology : AIMM,['10.1097/PAI.0000000000000632']
789,29478874,"Memory-Focused Cognitive Therapy for Cocaine Use Disorder: Theory, Procedures and Preliminary Evidence From an External Pilot Randomised Controlled Trial.","BACKGROUND


Cocaine use disorder (CUD) is a debilitating condition with no NICE-recommended medication or specific psychosocial interventions. In the United Kingdom (UK), general counselling (treatment-as-usual; TAU) is widely delivered, but has limited effectiveness. We tested the feasibility, safety and preliminary efficacy of a novel, adjunctive psychosocial intervention for CUD, called 'memory-focused cognitive therapy' (MFCT).
METHODS


We did a two-arm, external pilot randomised controlled trial at a specialist community National Health Service addictions clinic in London, UK. 30 adults (≥18years), voluntarily seeking treatment for CUD (enrolled ≥14days; all with moderate-to-severe DSM5 CUD), were individually randomised (1:1) to a control group (ongoing TAU; 3×90min CUD cognitive conceptualisation assessments; 2×30min cocaine-related cue-induction procedures; and 3×30min research follow-ups); or to an intervention group (ongoing TAU; 3×90min cognitive conceptualisation assessments; 2×30min cocaine-related cue-induction procedures; 5×120min, one-to-one, MFCT sessions [in 1week]; and 3×60min research follow-ups and MFCT-relapse prevention). The primary outcome was the total percentage score on the frequency version of the Craving Experiences Questionnaire (CEQ-F) at 1-month follow-up after the intensive intervention week (clinical endpoint; recall period past 2weeks; higher score indicating greater craving). Secondary outcomes at the 1-month follow-up were percentage days abstinent (PDA) from cocaine, and longest period (days) of continuous abstinence (LPA) in the prior 28days. Outcomes were analysed as an unadjusted group mean difference (with Hedge's g effect size [ES]) and a 95% Confidence Interval [CI] for the primary outcome and a 90% CI for the secondary outcomes. Exploratory, multivariable linear (primary outcome) and Poisson regression models (secondary outcomes), with sex, age, months of regular cocaine use, baseline outcome score, and group estimated the effectiveness of the intervention. The trial is registered with the ISCRTN (ISRCTN16462783).
FINDINGS


Between July 15, 2015, and November 27, 2016, 58 patients were assessed for eligibility and 30 participants were randomised (14 to the control group and 16 to the intervention). With outcome data collected for all participants at the endpoint, the intervention group mean CEQ-F score (14·77; SD 21·47) was lower than the control group mean (51·75; SD 22·72); ES -1·62; 95% CI -2·45 to -0·80. MFCT was associated with more cocaine abstinence in the intervention group (PDA 85·94; SD 18·96) than the control group (PDA 54·59; SD 30·29); ES 1·19; 90% CI 0·54 to 1·84. There was also greater maximum abstinence in the intervention group (LPA 15·69; SD 10·10) than the control group (6·00; SD 7·36); ES 1·06; 90% CI 0·41 to 1·70. Exploratory, confounder-adjusted regression models for this preliminary effect supported the treatment association for reduced craving experiences (CEQ-F Coef. -28·25; 95% CI -45·15 to -11·35); more abstinence (PDA Incidence Rate Ratio [IRR] 1·56; 95% CI 1·31 to 1·88); and greater maximum abstinence (LPA IRR 2·56; 95% CI 1·96 to 3·35), although relative weak unmeasured confounding could overturn these model-adjusted exposure-outcome associations. There were four serious adverse events (among three participants). None were judged related to study procedures or interventions.
INTERPRETATION


In this first external pilot randomised controlled trial of MFCT for CUD, we have shown that the intervention and control procedures and acceptable feasible and safe, and report preliminary evidence that MFCT is associated with reduced craving and increased abstinence. These findings support progression to a substantive trial.
FUNDING SOURCE


UK National Institute for Health Research, Biomedical Research Centre.",2018,MFCT was associated with more cocaine abstinence in the intervention group (PDA 85·94; SD 18·96) than the control group (PDA 54·59; SD 30·29); ES 1·19; 90% CI 0·54 to 1·84.,"['Cocaine Use Disorder', '58 patients were assessed for eligibility and 30 participants were randomised ', 'specialist community National Health Service addictions clinic in London, UK', '30 adults (≥18years), voluntarily seeking treatment for CUD (enrolled ≥14days; all with moderate-to-severe DSM5 CUD', 'Between July 15, 2015, and November 27, 2016']","[""novel, adjunctive psychosocial intervention for CUD, called 'memory-focused cognitive therapy' (MFCT"", 'MFCT', 'Memory-Focused Cognitive Therapy', 'control group (ongoing TAU; 3×90min CUD cognitive conceptualisation assessments; 2×30min cocaine-related cue-induction procedures; and 3×30min research follow-ups); or to an intervention group (ongoing TAU; 3×90min cognitive conceptualisation assessments; 2×30min cocaine-related cue-induction procedures; 5×120min, one-to-one, MFCT sessions [in 1week]; and 3×60min research follow-ups and MFCT-relapse prevention']","['1-month follow-up were percentage days abstinent (PDA) from cocaine, and longest period (days) of continuous abstinence (LPA', 'maximum abstinence', 'abstinence (PDA Incidence Rate Ratio [IRR', 'cocaine abstinence', 'total percentage score on the frequency version of the Craving Experiences Questionnaire (CEQ-F', 'serious adverse events', 'mean CEQ-F score']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0589138', 'cui_str': 'Conceptualization, function (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0035168'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",58.0,0.146905,MFCT was associated with more cocaine abstinence in the intervention group (PDA 85·94; SD 18·96) than the control group (PDA 54·59; SD 30·29); ES 1·19; 90% CI 0·54 to 1·84.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom. Electronic address: john.marsden@kcl.ac.uk.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Goetz', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meynen', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Mitcheson', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.""}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Stillwell', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Eastwood', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.""}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, United Kingdom; Department of Psychology, University of Sussex, United Kingdom.'}]",EBioMedicine,['10.1016/j.ebiom.2018.01.039']
790,31629646,Post-Acute Care for Older People Following Injury: A Randomized Controlled Trial.,"OBJECTIVES


The study sought to determine whether older people, on discharge from hospital and on referral to a supported discharge team (SDT), will have: (1) reduced length of stay in hospital; (2) reduced risk of hospital readmission; and (3) reduced healthcare costs.
DESIGN/INTERVENTION


Randomized controlled trial with follow-up at 4 and 12 months of post-acute home-based rehabilitation team (SDT). Programs were delivered by trained healthcare assistants, up to 4 times a day, 7 days a week, under the guidance of registered nurses, allied health, and geriatricians for up to 6 weeks.
PARTICIPANTS/SETTING


A total of 303 older women and 100 older men (mean age 81) in hospital because of injury, were randomized to either SDT (n = 201) or usual care (n = 202). The intervention was operated from Waikato hospital, a regional hospital in New Zealand.
METHODS


Days spent in hospital in the year following randomization and healthcare costs were collected from hospital datasets, and functional status assessed using the interRAI Contact Assessment was gathered by health professional research associates.
RESULTS


Participants randomized to the SDT spent less time in hospital in the period immediately prior to discharge (mean 20.9 days) in comparison to usual care (mean 26.6 days) and spent less time in hospital in the 12 months following discharge home. Healthcare costs were lower in the SDT group in the 12 months following randomization.
CONCLUSIONS/IMPLICATIONS


SDT can provide an important role in reducing hospital length of stay and readmissions of older people following an injury. Almost a million older people (65+ years of age) a year in the US are hospitalized as a consequence of falls-related injuries, most often fractured hip. Hospitals are not always the best location to provide care for older people. SDTs can help with the transition from hospital to home, while reducing hospital length-of-stay.",2020,"Healthcare costs were lower in the SDT group in the 12 months following randomization.
","['Older People', '303 older women and 100 older men (mean age 81) in hospital because of injury', 'Days spent in hospital in the year following randomization and healthcare costs were collected from hospital datasets, and functional status assessed using the interRAI Contact Assessment was gathered by health professional research associates', 'million older people (65+\xa0years of age', 'older people, on discharge from hospital and on referral to a supported discharge team (SDT']","['post-acute home-based rehabilitation team (SDT', 'SDT', 'usual care']","['healthcare costs', 'length of stay in hospital; (2) reduced risk of hospital readmission', 'Healthcare costs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}]",303.0,0.144412,"Healthcare costs were lower in the SDT group in the 12 months following randomization.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Parsons', 'Affiliation': 'Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand; Waikato District Health Board, Hamilton, New Zealand. Electronic address: m.parsons@auckland.ac.nz.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': 'Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand; Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'Avinesh', 'Initials': 'A', 'LastName': 'Pillai', 'Affiliation': 'Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rouse', 'Affiliation': 'The Business School, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mathieson', 'Affiliation': 'Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bregmen', 'Affiliation': 'Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kenealy', 'Affiliation': 'Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.015']
791,29337134,Acetylcholine Receptor Antibody Titers and Clinical Course after Influenza Vaccination in Patients with Myasthenia Gravis: A Double-Blind Randomized Controlled Trial (ProPATIent-Trial).,"BACKGROUND


It is a continuous matter of discussion whether immune activation by vaccination in general and Influenza vaccination in particular increases the risk for clinical deterioration of autoimmune diseases. This prospective study investigated the serological and clinical course of autoimmune Myasthenia gravis (MG) after a seasonal influenza vaccination.
METHODS


This randomized, placebo-controlled, double-blind study enrolled MG patients with antibodies against acetylcholine-receptors (AChR-ab). They were allocated to receive seasonal influenza vaccine or placebo. The primary endpoint was the relative change of AChR-ab-titer over 12weeks. A relative increase of 20% was set as non-inferiority margin. Secondary endpoints were clinical changes in the modified Quantitative Myasthenia Gravis Score (QMG), increase of anti-influenza-ELISA-antibodies, and changes of treatment. The study is registered with Clinicaltrialsregister.eu, EudraCT number 2006-004374-27.
FINDINGS


62 patients were included. Mean±standard deviation (median) in the vaccine and placebo group were AChR-ab-titer changes of -6.0%±23.3% (-4.0%) and -2.8%±22.0% (-0.5%) and QMG score changes of -0.08±0.27 (0.17) and 0.11±0.31 (0.00), respectively. The difference between groups (Hodges-Lehmann estimate with 95% CI) was - for the AChR-ab-titer change 4·0% [-13.3%, 4.5%] (p=0.28 for testing a difference, p<0.0001 for testing non-inferiority) and for the QMG change 0·00 [-0.17, 0.00] (p=0.79 for testing a difference). The occurrence of 74 adverse events (AE) was comparable between groups. The most common AE was flu-like symptoms. One serious AE (hospitalisation following gastrointestinal haemorrhage) in the verum group was not related to the vaccine.
INTERPRETATION


Influenza vaccination in MG is safe. Uprating the potential risk of a severe course of MG exacerbation during influenza infection compared to the 95% CI differences for the endpoints, vaccination is principally indicated in this patient population.",2018,The occurrence of 74 adverse events (AE) was comparable between groups.,"['enrolled MG patients with antibodies against acetylcholine-receptors (AChR-ab', '62 patients were included', 'Patients with Myasthenia Gravis', 'registered with Clinicaltrialsregister.eu, EudraCT number 2006-004374-27']","['placebo', 'seasonal influenza vaccine or placebo']","['relative change of AChR-ab-titer over 12weeks', 'Mean±standard deviation (median', 'occurrence of 74 adverse events (AE', 'QMG change 0·00', 'QMG score changes', 'clinical changes in the modified Quantitative Myasthenia Gravis Score (QMG), increase of anti-influenza-ELISA-antibodies, and changes of treatment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0034792', 'cui_str': 'Receptors, Acetylcholine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",62.0,0.664005,The occurrence of 74 adverse events (AE) was comparable between groups.,"[{'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tackenberg', 'Affiliation': 'Klinik für Neurologie, Philipps-Universität und Universitätsklinikum Marburg, Baldingerstr. 1, Marburg 35043, Germany. Electronic address: tackenbb@med.uni-marburg.de.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Klinik für Neurologie, Philipps-Universität und Universitätsklinikum Marburg, Baldingerstr. 1, Marburg 35043, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Blaes', 'Affiliation': 'Klinik für Neurologie, Klinikum Oberberg, Am Hüttenberg 1, Gummersbach 51643, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Eienbröker', 'Affiliation': 'Klinik für Neurologie, Philipps-Universität und Universitätsklinikum Marburg, Baldingerstr. 1, Marburg 35043, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'Koordinierungszentrum für Klinische Studien (KKS), Philipps-Universität, Karl-von-Frisch-Str. 4, Marburg 35043, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wellek', 'Affiliation': 'Klinik für Neurologie, Philipps-Universität und Universitätsklinikum Marburg, Baldingerstr. 1, Marburg 35043, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Deschauer', 'Affiliation': 'Klinik für Neurologie, Technische Universität München (TUM), Ismaninger Str. 22, München 81675, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'Institut für Virologie, Philipps-Universität, Hans-Meerwein-Str. 2, Marburg 35043, Germany.'}, {'ForeName': 'Hans-Dieter', 'Initials': 'HD', 'LastName': 'Klenk', 'Affiliation': 'Institut für Virologie, Philipps-Universität, Hans-Meerwein-Str. 2, Marburg 35043, Germany.'}, {'ForeName': 'Hans-Helge', 'Initials': 'HH', 'LastName': 'Müller', 'Affiliation': 'Institut für Medizinische Biometrie und Epidemiologie (IMBE), Philipps-Universität, Bunsenstr. 3, Marburg 35037, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Sommer', 'Affiliation': 'Klinik für Neurologie, Philipps-Universität und Universitätsklinikum Marburg, Baldingerstr. 1, Marburg 35043, Germany; Klinik für Neurologie, Klinikum Christophsbad, Faurndauer Str. 6, Göppingen 73035, Germany.'}]",EBioMedicine,['10.1016/j.ebiom.2018.01.007']
792,29453671,"Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus ® ) and Lantus ®  in healthy subjects: a double-blind, randomized clamp study.","AIMS


The objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus ®  (test) with the innovator's formulation Lantus ®  (reference) using the euglycemic clamp technique in a single-dose, double-blind, randomized, two sequences, four-period replicate crossover study in healthy volunteers (n = 40).
METHODS


Subjects received subcutaneous administration of the insulin glargine (0.4 IU/kg) formulation at two occasions for test and reference and a 20% glucose solution was infused at variable rate to maintain euglycemia for 24 h.
RESULTS


Both PK [area under the plasma concentration time curve (AUC 0-24 h ) and maximum insulin concentration (C max )] and PD endpoints [area under glucose infusion rate time curve ( AUCGIR0-24 ) and maximum glucose infusion rate (GIR max )] demonstrated bioequivalence of Glaritus to Lantus with the 90% confidence interval of geometric mean ratio of test to reference entirely contained within 0.80-1.25. Both formulations showed equivalent geometric least-square mean LSM value (0.08 nmol/L) for C max . The geometric LSM AUC 0-24 h  value for Glaritus ®  (1.09 h nmol/L) was comparable to Lantus (1.05 h nmol/L). Median T max  values were also identical (12 h for both), and median t1/2 values were also equal (18 h for both). For GIR Tmax , the difference between the means for the two was not statistically significant. No AEs related to study formulations were reported, and both products were well tolerated.
CONCLUSIONS


The test product (Glaritus) was found to be bioequivalent to the reference product (Lantus).
CLINICAL TRIAL REGISTRATION NUMBER


CTRI/2015/06/005890; http://www.ctri.nic.in/ .",2018,"The test product (Glaritus) was found to be bioequivalent to the reference product (Lantus).
","['Subjects received', 'healthy volunteers (n\xa0=\xa040', 'healthy subjects']","[""insulin glargine formulation, Glaritus ®  (test) with the innovator's formulation Lantus ®  (reference) using the euglycemic clamp technique"", 'subcutaneous administration of the insulin glargine', 'insulin glargine (Glaritus ® ']","['tolerated', 'plasma concentration time curve (AUC 0-24\xa0h ) and maximum insulin concentration (C max )] and PD endpoints [area under glucose infusion rate time curve ( AUCGIR0-24 ) and maximum glucose infusion rate (GIR max ', 'Median T max  values', 'equivalent geometric least-square mean LSM value', 'pharmacokinetic (PK) and pharmacodynamic (PD) properties']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0876064', 'cui_str': 'Lantus'}, {'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",,0.200154,"The test product (Glaritus) was found to be bioequivalent to the reference product (Lantus).
","[{'ForeName': 'Ashima', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Tawade', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Mushtaque', 'Initials': 'M', 'LastName': 'Mastim', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Eliford Ngaimisi', 'Initials': 'EN', 'LastName': 'Kitabi', 'Affiliation': 'School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Mathangi', 'Initials': 'M', 'LastName': 'Gopalakrishnan', 'Affiliation': 'School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA. mgopalakrishnan@rx.umaryland.edu.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Yeshamaina', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Joga', 'Initials': 'J', 'LastName': 'Gobburu', 'Affiliation': 'School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Maharaj', 'Initials': 'M', 'LastName': 'Sahib', 'Affiliation': 'Wockhardt, Research Center, Aurangabad, India.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Thakur', 'Affiliation': 'Wockhardt, Research Center, Aurangabad, India.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Prasanna Kumar', 'Affiliation': 'Centre for Diabetes and Endocrine Care, Bengaluru, India.'}]",Acta diabetologica,['10.1007/s00592-018-1113-3']
793,31619358,Randomized Clinical Trial Comparing Femtosecond LASIK and Small-Incision Lenticule Extraction.,"PURPOSE


To compare femtosecond LASIK with small-incision lenticule extraction (SMILE) for the treatment of myopia and myopic astigmatism.
DESIGN


Prospective, randomized, paired-eye, single-masked clinical trial.
PARTICIPANTS


Consecutive eligible patients were randomized to undergo SMILE and LASIK in either eye at a single tertiary referral eye center.
METHODS


Patients were treated in each eye using the VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system. Excimer ablation was subsequently performed using the WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX) in the eye for LASIK.
MAIN OUTCOME MEASURE


Refractive predictability at 3 months. Secondary outcomes were refractive outcomes, that is, efficacy and safety at 3 and 12 months.
RESULTS


We recruited 70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (-5.3±1.8 diopters [D] vs. -5.2±1.7 D; P = 0.87). At 3 months, 99% of SMILE eyes and 97% of LASIK eyes achieved SE within ±1.0 D of attempted correction (P = 1.0). Small-incision lenticule extraction achieved similar results as LASIK in terms of efficacy index (0.97±0.20 vs. 0.99±0.20; P = 0.56), uncorrected distance visual acuity (UDVA) of 20/40 or better (100% vs. 100%; P = 1.0), and UDVA of 20/20 or better (84% vs. 87%; P = 0.63). Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months. At 12 months, SMILE was similar to LASIK in terms of efficacy (85% vs. 83% UDVA ≥20/20; P = 0.81), predictability (99% vs. 99% ±1.0 D of attempted correction SE; P = 1.0), and safety (1.15±0.20 vs. 1.15±0.20; P = 0.93).
CONCLUSIONS


The results from this randomized trial suggest that SMILE produced promising refractive outcomes in terms of predictability, efficacy, and safety at 3 and 12 months of follow-up.",2020,Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months.,"['Consecutive eligible patients', 'Patients were treated in each eye using the', 'in either eye at a single tertiary referral eye center', '70 consecutive patients (mean age, 28±5 years; 64% women; all Asian) with no difference in preoperative spherical equivalent (SE) between eyes (-5.3±1.8 diopters [D] vs. -5.2±1.7 D; P\xa0= 0.87']","['VisuMax (Carl Zeiss Meditec, Jena, Germany) 500-kHz femtosecond laser system', 'Excimer ablation', 'Femtosecond LASIK and Small-Incision Lenticule Extraction', 'SMILE and LASIK', 'WaveLight EX500 excimer laser (Alcon Laboratories, Inc, Fort Worth, TX', 'SMILE', 'femtosecond LASIK with small-incision lenticule extraction (SMILE']","['refractive outcomes, that is, efficacy and safety', 'uncorrected distance visual acuity (UDVA', 'Safety index', 'predictability', 'predictability, efficacy, and safety', 'Refractive predictability', 'efficacy index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}]","[{'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0752094', 'cui_str': 'Laser-Assisted Stromal In Situ Keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0392265', 'cui_str': 'Lasers, Excimer'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",70.0,0.216313,Safety index (1.1±0.2 vs. 1.1±0.2; P = 0.57) was similar between SMILE and LASIK eyes at 3 months.,"[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ang', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore. Electronic address: marcus.ang@snec.com.sg.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Farook', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore.'}, {'ForeName': 'Hla M', 'Initials': 'HM', 'LastName': 'Htoon', 'Affiliation': 'Singapore Eye Research Institute, Singapore, Republic of Singapore; Department of Ophthalmology and Visual Science, Duke-NUS Graduate Medical School, Singapore, Republic of Singapore.'}, {'ForeName': 'Jodhbir S', 'Initials': 'JS', 'LastName': 'Mehta', 'Affiliation': 'Cornea and Refractive Service, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore; Department of Ophthalmology and Visual Science, Duke-NUS Graduate Medical School, Singapore, Republic of Singapore.'}]",Ophthalmology,['10.1016/j.ophtha.2019.09.006']
794,31631029,Identifying Key Risk Factors for Dizziness Handicap in Middle-Aged and Older People.,"OBJECTIVES


More than 10% of people aged 50 years and older report dizziness. Despite available treatments, dizziness remains unresolved for many people due in part to suboptimal assessment. We aimed to identify factors associated with dizziness handicap in middle-aged and older people to identify targets for intervention to address this debilitating problem. A secondary aim was to determine whether factors associated with dizziness differed between middle-aged (<70 years) and older people (≥ 70 years).
DESIGN


Secondary analysis of baseline and prospective data from a randomized controlled trial.
SETTING AND PARTICIPANTS


In total, 305 individuals aged 50 to 92 years reporting significant dizziness in the past year were recruited from the community.
METHODS


Participants were classified as having either mild or no dizziness handicap (score <31) or moderate/severe dizziness handicap (score: 31‒100) based on the Dizziness Handicap Inventory. Participants completed health questionnaires and underwent assessments of psychological well-being, lying and standing blood pressure, vestibular function, strength, vision, proprioception, processing speed, balance, stepping, and gait. Participants reported dizziness episodes in monthly diaries for 6 months following baseline assessment.
RESULTS


Dizziness Handicap Inventory scores ranged from 0 to 86 with 95 participants (31%) reporting moderate/severe dizziness handicap. Many vestibular, cardiovascular, psychological, balance-related, and medical/medications measures were significantly associated with dizziness handicap severity and dizziness episode frequency. Binary logistic regression identified a positive Dix Hallpike/head-roll test for benign paroxysmal positional vertigo [odds ratio (OR) 2.09, 95% confidence interval (CI) (1.11‒3.97)], cardiovascular medication use [OR 1.90, 95% CI (1.09‒3.32)], high postural sway when standing on the floor with eyes closed (sway path ≥160 mm) [OR 2.97, 95% CI (1.73‒5.10)], and anxiety (Generalized Anxiety Disorder Scale 7-item Scale score ≥8) [OR 3.08, 95% CI (1.36‒6.94)], as significant and independent predictors of moderate/severe dizziness handicap. Participants aged 70 years and over were significantly more likely to report cardiovascular conditions than those aged less than 70 years old.
CONCLUSIONS AND IMPLICATIONS


Assessments of cardiovascular conditions and cardiovascular medication use, benign paroxysmal positional vertigo, anxiety, and postural sway identify middle-aged and older people with significant dizziness handicap. A multifactorial assessment including these factors may assist in tailoring evidence-based therapies to alleviate dizziness handicap in this group.",2020,"Many vestibular, cardiovascular, psychological, balance-related, and medical/medications measures were significantly associated with dizziness handicap severity and dizziness episode frequency.","['Participants aged 70 years and over were significantly more likely to report cardiovascular conditions than those aged less than 70 years old', 'Middle-Aged and Older People', 'middle-aged and older people', 'middle-aged (<70 years) and older people (≥ 70 years', '305 individuals aged 50 to 92\xa0years reporting significant dizziness in the past year were recruited from the community', 'More than 10% of people aged 50\xa0years and older report dizziness', 'middle-aged and older people with significant dizziness handicap', 'Participants were classified as having either mild or no dizziness handicap (score <31) or moderate/severe dizziness handicap (score: 31‒100) based on the Dizziness Handicap Inventory']",[],"['health questionnaires and underwent assessments of psychological well-being, lying and standing blood pressure, vestibular function, strength, vision, proprioception, processing speed, balance, stepping, and gait', 'dizziness', 'moderate/severe dizziness handicap', 'anxiety (Generalized Anxiety Disorder Scale 7-item Scale score ≥8', 'Dizziness Handicap Inventory scores', 'high postural sway', 'cardiovascular medication use', 'dizziness handicap', 'Dizziness Handicap', 'dizziness episodes', 'dizziness handicap severity and dizziness episode frequency']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0580945', 'cui_str': 'Standing blood pressure'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",305.0,0.157614,"Many vestibular, cardiovascular, psychological, balance-related, and medical/medications measures were significantly associated with dizziness handicap severity and dizziness episode frequency.","[{'ForeName': 'Jasmine C', 'Initials': 'JC', 'LastName': 'Menant', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Meinrath', 'Affiliation': 'Department of Physiotherapy, Prince of Wales Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daina L', 'Initials': 'DL', 'LastName': 'Sturnieks', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia; School of Medical Sciences, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Hicks', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mayna', 'Initials': 'M', 'LastName': 'Ratanapongleka', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Americo A', 'Initials': 'AA', 'LastName': 'Migliaccio', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia; Graduate School of Biomedical Engineering, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nickolai', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jacqueline C T', 'Initials': 'JCT', 'LastName': 'Close', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'Neuroscience Research Australia, Sydney, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia. Electronic address: s.lord@neura.edu.au.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.016']
795,31521872,Whose depression deteriorates during acute phase antidepressant treatment?,"BACKGROUND


Few studies have investigated the proportion of patients with depression who experience worsening of depression symptoms during adequate antidepressant treatment. The current study aimed to investigate the proportion and predictors of worsening depression during antidepressant treatment in a multi-center randomized trial involving patients with major depression.
METHODS


We defined the deterioration of depression using depression symptom severity evaluated by total Patient Health Questionnaire (PHQ-9) score increases from week 0 to week 9 during acute phase antidepressant treatment. Patients' baseline demographic and clinical data, change in PHQ-9 scores from week 0 to week 3, and side effects at week 3 were evaluated as potential predictors of subsequent deterioration of depression.
RESULTS


Of 1,647 patients, 99 (6.0%) exhibited deterioration of depression, and this proportion was smaller when reliable change index criteria were applied. Logistic regression analysis revealed that the following factors were significantly associated with deterioration of depression: younger age at onset of first episode of major depressive disorder, current older age, and greater increase in PHQ-9 scores between week 0 and week 3.
LIMITATIONS


The time of the primary endpoint might not have been sufficiently long. The present study did not include a placebo arm, and potentially relevant predictors might not have been comprehensively investigated.
CONCLUSIONS


A small proportion of patients may experience deterioration of depression during acute phase antidepressant treatment. Age at onset at first depressive episode, current age, and early negative response to antidepressants may be useful predictors of subsequent worsening of depression.",2020,"RESULTS


Of 1,647 patients, 99 (6.0%) exhibited deterioration of depression, and this proportion was smaller when reliable change index criteria were applied.","['patients with depression who experience worsening of depression symptoms during adequate antidepressant treatment', 'patients with major depression']",['placebo'],"['deterioration of depression using depression symptom severity evaluated by total Patient Health Questionnaire (PHQ-9) score', 'PHQ-9 scores', 'deterioration of depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1647.0,0.0241433,"RESULTS


Of 1,647 patients, 99 (6.0%) exhibited deterioration of depression, and this proportion was smaller when reliable change index criteria were applied.","[{'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Sugishita', 'Affiliation': 'Oji Mental Clinic.'}, {'ForeName': 'Bun', 'Initials': 'B', 'LastName': 'Chino', 'Affiliation': 'Ginza Taimei Clinic.'}, {'ForeName': 'Kahori', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Sinsapporo Mental Clinic.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Narumi Himawari Clinic.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Shimodera', 'Affiliation': 'Department of Neuropsychiatry, Kochi Medical School.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yonemoto', 'Affiliation': 'Department of Biostatistics, Kyoto University School of Public Health.'}, {'ForeName': 'Kazuhira', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Miki Mental Clinic.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University.'}, {'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Takeshima', 'Affiliation': 'Kyoto University Graduate School of Medicine/School of Public Health Department of Health Promotion of Human Behavior.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Aratama Kokorono Clinic.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.052']
796,29300098,Effectiveness and application of an online leadership intervention to promote mental health and reduce depression-related stigma in organizations.,"Addressing the stigma of mental illness and its effect in the workplace is a contemporary issue in occupational health. The role of leaders is a vital but relatively unexplored dimension of this phenomenon. This study examined the effectiveness and application of an online intervention to reduce depression-related stigma in organizational leaders. A randomized controlled, ""in the field"" study was conducted with 196 leaders. Participants completed an online survey and were randomly assigned to either the experimental or wait-list control group. One week later, participants in the experimental group were given access to a brief online workplace mental health intervention and asked to complete a postsurvey, whereas the control group had to only complete the online postsurvey. Six months later, participants completed a follow-up online survey. Results revealed significant reductions in behavioral and affective depression-related stigma scores among leaders who completed the intervention, compared with the control group. These reductions were similar at 6 months. The factors that enabled or hindered training transfer from the intervention were examined through semistructured interviews with 16 of the participating leaders. Results showed that positive attitudes and high levels of knowledge are not sufficient to ensure leaders apply intervention learning in their work environments. Factors including the nature of the work environment, the collective readiness and capability of the organization to address these issues, the attitudes of others at work, and the broader political context affected the application of learning from the intervention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Results revealed significant reductions in behavioral and affective depression-related stigma scores among leaders who completed the intervention, compared with the control group.",['196 leaders'],"['brief online workplace mental health intervention', 'online intervention', 'online leadership intervention', 'experimental or wait-list control group']",['behavioral and affective depression-related stigma scores'],"[{'cui': 'C4517625', 'cui_str': '196'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0275848,"Results revealed significant reductions in behavioral and affective depression-related stigma scores among leaders who completed the intervention, compared with the control group.","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Shann', 'Affiliation': 'Shann Advisory.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'School of Business and Economics, Tasmanian School of Business and Economics, University of Tasmania.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Chester', 'Affiliation': 'School of Education, RMIT University.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ruddock', 'Affiliation': 'School of Psychology, Australian Catholic University.'}]",Journal of occupational health psychology,['10.1037/ocp0000110']
797,29456191,Comparative efficacy of low-dose versus standard-dose azithromycin for patients with yaws: a randomised non-inferiority trial in Ghana and Papua New Guinea.,"BACKGROUND


A dose of 30 mg/kg of azithromycin is recommended for treatment of yaws, a disease targeted for global eradication. Treatment with 20 mg/kg of azithromycin is recommended for the elimination of trachoma as a public health problem. In some settings, these diseases are co-endemic. We aimed to determine the efficacy of 20 mg/kg of azithromycin compared with 30 mg/kg azithromycin for the treatment of active and latent yaws.
METHODS


We did a non-inferiority, open-label, randomised controlled trial in children aged 6-15 years who were recruited from schools in Ghana and schools and the community in Papua New Guinea. Participants were enrolled based on the presence of a clinical lesion that was consistent with infectious primary or secondary yaws and a positive rapid diagnostic test for treponemal and non-treponemal antibodies. Participants were randomly assigned (1:1) to receive either standard-dose (30 mg/kg) or low-dose (20 mg/kg) azithromycin by a computer-generated random number sequence. Health-care workers assessing clinical outcomes in the field were not blinded to the patient's treatment, but investigators involved in statistical or laboratory analyses and the participants were blinded to treatment group. We followed up participants at 4 weeks and 6 months. The primary outcome was cure at 6 months, defined as lesion healing at 4 weeks in patients with active yaws and at least a four-fold decrease in rapid plasma reagin titre from baseline to 6 months in patients with active and latent yaws. Active yaws was defined as a skin lesion that was positive for Treponema pallidum ssp pertenue in PCR testing. We used a non-inferiority margin of 10%. This trial was registered with ClinicalTrials.gov, number NCT02344628.
FINDINGS


Between June 12, 2015, and July 2, 2016, 583 (65·1%) of 895 children screened were enrolled; 292 patients were assigned a low dose of azithromycin and 291 patients were assigned a standard dose of azithromycin. 191 participants had active yaws and 392 had presumed latent yaws. Complete follow-up to 6 months was available for 157 (82·2%) of 191 patients with active yaws. In cases of active yaws, cure was achieved in 61 (80·3%) of 76 patients in the low-dose group and in 68 (84·0%) of 81 patients in the standard-dose group (difference 3·7%; 95% CI -8·4 to 15·7%; this result did not meet the non-inferiority criterion). There were no serious adverse events reported in response to treatment in either group. The most commonly reported adverse event at 4 weeks was gastrointestinal upset, with eight (2·7%) participants in each group reporting this symptom.
INTERPRETATION


In this study, low-dose azithromycin did not meet the prespecified non-inferiority margin compared with standard-dose azithromycin in achieving clinical and serological cure in PCR-confirmed active yaws. Only a single participant (with presumed latent yaws) had definitive serological failure. This work suggests that 20 mg/kg of azithromycin is probably effective against yaws, but further data are needed.
FUNDING


Coalition for Operational Research on Neglected Tropical Diseases.",2018,Active yaws was defined as a skin lesion that was positive for Treponema pallidum ssp pertenue in PCR testing.,"['patients with yaws', 'and 291 patients', '191 participants had active yaws and 392 had presumed latent yaws', 'children aged 6-15 years who were recruited from schools in Ghana and schools and the community in Papua New Guinea', 'Ghana and Papua New Guinea', 'Participants were enrolled based on the presence of a clinical lesion that was consistent with infectious primary or secondary yaws and a positive rapid diagnostic test for treponemal and non-treponemal antibodies', 'Between June 12, 2015, and July 2, 2016, 583 (65·1%) of 895 children screened were enrolled; 292 patients', '191 patients with active yaws']","['low-dose versus standard-dose azithromycin', 'azithromycin']","['rapid plasma reagin titre', 'definitive serological failure', 'cure at 6 months, defined as lesion healing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0043388', 'cui_str': 'Frambesia Tropica'}, {'cui': 'C0153240', 'cui_str': 'Latent yaws (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030375', 'cui_str': 'New Guinea, East'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086143'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0034761', 'cui_str': 'Reagins'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",191.0,0.366636,Active yaws was defined as a skin lesion that was positive for Treponema pallidum ssp pertenue in PCR testing.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Hospital for Tropical Diseases, London, UK. Electronic address: michael.marks@lshtm.ac.uk.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Mitjà', 'Affiliation': 'Barcelona Institute for Global Health, University of Barcelona, Barcelona, Spain; Lihir Medical Centre, International SOS, Newcrest Mining, Lihir Island, Papua New Guinea.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Public Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kwakye', 'Affiliation': 'Ghana Health Services, Accra, Ghana.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Houinei', 'Affiliation': 'Department of Health, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Bauri', 'Affiliation': 'Department of Health, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Adwere', 'Affiliation': 'Ghana Health Services, Accra, Ghana.'}, {'ForeName': 'Abdul A', 'Initials': 'AA', 'LastName': 'Abdulai', 'Affiliation': 'Ghana Health Services, Accra, Ghana.'}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Dua', 'Affiliation': 'Ghana Health Services, Accra, Ghana.'}, {'ForeName': 'Laud', 'Initials': 'L', 'LastName': 'Boateng', 'Affiliation': 'Ghana Health Services, Accra, Ghana.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wangi', 'Affiliation': 'World Health Organization Country Office, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Sally-Ann', 'Initials': 'SA', 'LastName': 'Ohene', 'Affiliation': 'World Health Organization Country Office, Accra, Ghana.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Wangnapi', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.'}, {'ForeName': 'Shirley V', 'Initials': 'SV', 'LastName': 'Simpson', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, Accra, Ghana.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Miag', 'Affiliation': 'Department of Health, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Kennedy K', 'Initials': 'KK', 'LastName': 'Addo', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, Accra, Ghana.'}, {'ForeName': 'Laud A', 'Initials': 'LA', 'LastName': 'Basing', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Danavall', 'Affiliation': 'Molecular Diagnostics and Typing Laboratory, Laboratory Reference and Research Branch, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kai H', 'Initials': 'KH', 'LastName': 'Chi', 'Affiliation': 'Molecular Diagnostics and Typing Laboratory, Laboratory Reference and Research Branch, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Pillay', 'Affiliation': 'Molecular Diagnostics and Typing Laboratory, Laboratory Reference and Research Branch, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Ballard', 'Affiliation': 'Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Solomon', 'Affiliation': 'Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Cheng Y', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Molecular Diagnostics and Typing Laboratory, Laboratory Reference and Research Branch, Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Sibauk V', 'Initials': 'SV', 'LastName': 'Bieb', 'Affiliation': 'Department of Public Health, National Department of Health, Waigani, Papua New Guinea.'}, {'ForeName': 'Yaw', 'Initials': 'Y', 'LastName': 'Adu-Sarkodie', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'David C W', 'Initials': 'DCW', 'LastName': 'Mabey', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK; Hospital for Tropical Diseases, London, UK.'}, {'ForeName': 'Kingsley', 'Initials': 'K', 'LastName': 'Asiedu', 'Affiliation': 'Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(18)30023-8']
798,29401202,Effects of Different Plyometric Training Frequency on Measures of Athletic Performance in Prepuberal Male Soccer Players.,"This study aimed to compare the effects of one vs. two sessions of equal-weekly volume plyometric training (PT) across 8 weeks on measures of athletic performance (i.e., sprint-time, change of direction [CoD], jumping ability, and muscle strength) in prepuberal male soccer players. Thirty participants were randomly assigned either to one session PT group (1SPT [n=15]) or two sessions PT group (2SPT [n=15]). Plyometric training was integrated into their regular soccer training routine. Pre- and post-training tests for the assessment of sprint-time (e.g., 5-m, 10-m, 20-m, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], counter-movement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance were conducted. Results showed a main effect of time for 5-m sprint-time performance (F(1,56)=4.00, ES=0.53 [medium], p=0.05), T-test (F(1,56)=23.19, ES=1.28 [large], p<0.001), MICODT (F(1,56)= 5.72, ES=0.94 [large], p=0.02), SLJ (F(1,56)=16.63, ES=1.09 [large], p<0.001), CMJ (F(1,56) =15.43, ES= 1.04 [large], p<0.001), SJ (F(1,56) =20.27, ES=1.20 [large], p<0.001), RSI (F(1,56)=26.26, ES=1.36 [large], p<0.001), and kicking distance (F(1,56)=47.19, ES=1.83 [large], p<0.001). There were no training group × time interactions in all the measured outcomes. In conclusion, when an equated moderate volume of jumps is performed, higher PT frequency across 8 weeks has no extra-effects on prepuberal male soccer players' measures of athletic performance. The present findings may help optimizing PT interventions dedicated to prepuberal male soccer players.",2018,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56)=4.00, ES=0.53 [medium], p=0.05), T-test (F(1,56)=23.19, ES=1.28 [large], p<0.001), MICODT (F(1,56)= 5.72, ES=0.94 [large], p=0.02), SLJ (F(1,56)=16.63, ES=1.09 [large], p<0.001), CMJ (F(1,56) =15.43,","['prepuberal male soccer players', 'Thirty participants', 'Prepuberal Male Soccer Players']","['Plyometric training', 'Plyometric Training Frequency', 'equal-weekly volume plyometric training (PT']","['Athletic Performance', 'athletic performance', 'athletic performance (i.e., sprint-time, change of direction [CoD], jumping ability, and muscle strength', 'time for 5-m sprint-time performance', 'RSI', 'kicking distance', 'time interactions', 'sprint-time (e.g., 5-m, 10-m, 20-m, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], counter-movement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0328368,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56)=4.00, ES=0.53 [medium], p=0.05), T-test (F(1,56)=23.19, ES=1.28 [large], p<0.001), MICODT (F(1,56)= 5.72, ES=0.94 [large], p=0.02), SLJ (F(1,56)=16.63, ES=1.09 [large], p<0.001), CMJ (F(1,56) =15.43,","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': ""Research Unit (UR17JS01) 'Sport Performance & Health' Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.""}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Am Neuen Palais 10, 14469 Potsdam, Germany.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': ""Research Unit (UR17JS01) 'Sport Performance & Health' Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Jlalia', 'Affiliation': 'Faculty of Medicine of Tunis, University of Tunis El Manar, Orthopedic pediatric department, Kassab institute of orthopedic surgery, Ksar said, Tunisia.'}, {'ForeName': 'Bessem', 'Initials': 'B', 'LastName': 'Mkaouer', 'Affiliation': 'Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Younés', 'Initials': 'Y', 'LastName': 'Hachana', 'Affiliation': ""Research Unit (UR17JS01) 'Sport Performance & Health' Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.""}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002486']
799,29410180,Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report.,"The purpose of this report is to analyze long-term clinical outcomes of patients exposed to plerixafor plus granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization. This was a study of patients with non-Hodgkin lymphoma (NHL; n = 167) and multiple myeloma (MM; n = 163) who were enrolled in the long-term follow-up of 2 pivotal phase III studies (NCT00741325 and NCT00741780) of 240 µg/kg plerixafor plus 10 µg/kg G-CSF, or placebo plus 10 µg/kg G-CSF to mobilize and collect CD34 +  cells for autologous hematopoietic stem cell transplantation. Overall survival (OS) and progression-free survival (PFS) were evaluated over a 5-year period following the first dose of plerixafor or placebo. The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively). In addition, there was no statistically significant difference in the probability of PFS over 5 years between treatment groups in patients with NHL (50%; 95% CI, 44% to 67% for plerixafor versus 43%; 95% CI, 31% to 54% for placebo) or those with MM (17%; 95% CI, 10% to 24% for plerixafor versus 30%; 95% CI, 21% to 40% for placebo). In this long-term follow-up study, the addition of plerixafor to G-CSF for stem cell mobilization did not affect 5-year survival in patients with NHL or patients with MM.",2018,"The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively).","['Patients with Non-Hodgkin Lymphoma and Multiple Myeloma', 'autologous hematopoietic stem cell transplantation', 'patients with NHL or patients with MM', 'patients with non-Hodgkin lymphoma (NHL; n\u2009=\u2009167) and multiple myeloma (MM; n\u2009=\u2009163) who were enrolled in the long-term follow-up of 2 pivotal phase III studies (NCT00741325 and NCT00741780) of 240\u2009µg/kg']","['placebo', 'plerixafor', 'plerixafor plus 10\u2009µg/kg G-CSF, or placebo plus 10', 'plerixafor or placebo (NHL', 'plerixafor plus granulocyte colony-stimulating factor (G-CSF', 'Plerixafor Plus Granulocyte Colony-Stimulating Factor']","['Overall survival (OS) and progression-free survival (PFS', '5-year survival', 'probability of PFS', 'probability of OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.329175,"The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively).","[{'ForeName': 'Ivana N', 'Initials': 'IN', 'LastName': 'Micallef', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Stiff', 'Affiliation': 'Division of Hematology/Oncology, Loyola University, Chicago, Illinois.'}, {'ForeName': 'Auayporn P', 'Initials': 'AP', 'LastName': 'Nademanee', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Maziarz', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Horwitz', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapy, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Stadtmauer', 'Affiliation': 'Division of Hematology/Oncology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'McCarty', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Vargo', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Cheverton', 'Affiliation': 'Sanofi, Cambridge, Massachusetts.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Struijs', 'Affiliation': 'Sanofi, Naarden, The Netherlands.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bolwell', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Division of Oncology, Washington University School of Medicine, St. Louis, Missouri. Electronic address: jdipersi@wustl.edu.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2018.01.039']
800,31618099,Entitled Due to Deprivation vs. Superiority: Evidence That Unidimensional Entitlement Scales Blend Distinct Entitlement Rationales across Psychological Dimensions.,"We aimed to corroborate the notion that the Psychological Entitlement Scale (PES), a popular unidimensional index of psychological entitlement, resembles a blend of vulnerable- and grandiose-based entitlement rationales across various psychological dimensions. College participants ( N  = 523) were randomly assigned to complete either the PES or a recently validated, multidimensional adaptation of the PES that purports to assess entitlement due to deprivation (vulnerable-based entitlement; ""PES-V"") and superiority (grandiose-based entitlement; ""PES-G"") claims. Participants then completed a battery of psychological dimensions including: narcissism constructs, interpersonal vulnerability and mood pathology, psychological health, normal personality and personality-disorder traits, motivation systems, a deprived identity, and status aspiration. Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions. Likewise, additional analyses revealed that indicators of ""narcissistic entitlement"" exhibited stronger profile similarity to PES-G than PES-V across psychological dimensions. In conclusion, profiles of the PES and narcissistic entitlement appear to blend grandiose- and vulnerable-based entitlement, but grandiose-based (vs. vulnerable-based) entitlement seems more prominent in the blend. As a result, unidimensional measures can create a somewhat misleading portrait of the psychologically entitled.",2020,Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions.,['College participants ( N \u2009=\u2009523'],"['PES or a recently validated, multidimensional adaptation of the PES that purports to assess entitlement due to deprivation (vulnerable-based entitlement; ""PES-V"") and superiority (grandiose-based entitlement; ""PES-G"") claims']","['Psychological Entitlement Scale (PES', 'narcissism constructs, interpersonal vulnerability and mood pathology, psychological health, normal personality and personality-disorder traits, motivation systems, a deprived identity, and status aspiration']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0027401', 'cui_str': 'Narcissism'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0031212', 'cui_str': 'Personality Disorders'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]",523.0,0.02893,Profile-similarity indices indicated that PES was more similar to PES-G than PES-V across psychological dimensions.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hart', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Tortoriello', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Breeden', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}]",Journal of personality assessment,['10.1080/00223891.2019.1674319']
801,31356878,Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis: results from a randomized controlled phase 2a trial.,"OBJECTIVE


To investigate the TrkA inhibitor, ASP7962, for treatment of painful knee osteoarthritis.
DESIGN


Phase 2a, double-blind, placebo- and naproxen-controlled, double-dummy, parallel-group study. Adults with knee osteoarthritis were randomized (2:2:1) to ASP7962 (100 mg), placebo, or naproxen (500 mg) twice daily (BID) for 4 weeks. Primary endpoint: change from baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score. Secondary endpoints: change from baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score.
RESULTS


215 participants were randomized (ASP7962 100 mg BID, n = 85; placebo, n = 87; naproxen 500 mg BID, n = 43). No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (-0.14; 90% 2-sided CI: -0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (-0.67; 80% 2-sided CI: -1.12, -0.23; P = 0.027). No differences were observed between ASP7962 and placebo in change from baseline in any WOMAC subscale score; statistically significant changes were observed between naproxen and placebo (P ≤ 0.01, all time points for all WOMAC endpoints). ASP7962 was safe and well-tolerated.
CONCLUSIONS


Four-week treatment with ASP7962 (100 mg BID) did not improve pain or physical function in individuals with painful knee osteoarthritis. ClinicalTrials.gov, NCT02611466; EudraCT Number, 2014-004996-22.",2019,"No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (-0.14; 90% 2-sided CI: -0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (-0.67; 80% 2-sided CI: -1.12, -0.23; P = 0.027).","['215 participants were', 'individuals with painful knee osteoarthritis', 'painful knee osteoarthritis', 'Adults with knee osteoarthritis']","['ASP7962', 'naproxen', 'placebo, or naproxen', 'placebo', 'TrkA inhibitor, ASP7962', 'randomized (ASP7962 100\xa0mg BID, n\xa0=\xa085; placebo, n\xa0=\xa087; naproxen', 'placebo- and naproxen', 'Tropomyosin-related kinase A (TrkA) inhibition', 'ASP7962 and placebo']","['baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score', 'safe and well-tolerated', 'baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score', 'WOMAC subscale score', 'WOMAC pain subscale score', 'pain or physical function']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0041197', 'cui_str': 'Tropomyosin'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",215.0,0.460245,"No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (-0.14; 90% 2-sided CI: -0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (-0.67; 80% 2-sided CI: -1.12, -0.23; P = 0.027).","[{'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Watt', 'Affiliation': 'Centre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Roosevelt Drive Headington, Oxford, UK. Electronic address: fiona.watt@kennedy.ox.ac.uk.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Blauwet', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA. Electronic address: MaryBeth.Blauwet@Astellas.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fakhoury', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA. Electronic address: Al.Fakhoury@astellas.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jacobs', 'Affiliation': 'Formerly with Astellas Pharma Global Development, Leiden, the Netherlands. Electronic address: helenejacobs@hotmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Smulders', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA. Electronic address: Ronald.Smulders@astellas.com.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'Center for Musculoskeletal Health, University of California at Davis Medical Center, Sacramento, CA, USA. Electronic address: nelane@ucdavis.edu.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.05.029']
802,31860360,Detecting Feigning in Adolescents on the Personality Assessment Inventory-Adolescent Form.,"Much of the research on identifying feigning in psychological assessment has focused on adults with less attention to adolescents. The purpose of the present study is to expand the limited literature on detecting feigning in adolescents using the Personality Assessment Inventory - Adolescent. The study included 114 nonclinical adolescents (ages 15 to 18) recruited from high schools in the Midwest who were randomly assigned to experimental groups: honest nonclinical, uncoached feigning, and coached feigning. 50 randomly selected individuals with depression from the PAI-A clinical standardization sample were included as the honest clinical group. Sample demographics included a mean age of 16.64 years; 51.2% young men, 48.2% young women; 85.4% Caucasian, 6.7% African American, 5.5% Hispanic, and 2.4% Asian. 80% of feigning profiles reported clinical levels of depression. MANOVA results showed strong support for the Rogers Discriminant Function (RDF;  d  range = 1.85-2.05). The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70). The negative distortion indices showed good utility in differentiating between groups. Cut-scores and pragmatic implications are presented.",2020,"The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70).","['adolescents using the Personality Assessment Inventory - Adolescent', 'Sample demographics included a mean age of 16.64\u2009years; 51.2% young men, 48.2% young women; 85.4% Caucasian, 6.7% African American, 5.5% Hispanic, and 2.4% Asian', '50 randomly selected individuals with depression from the PAI-A clinical standardization sample were included as the honest clinical group', 'Adolescents on the Personality Assessment Inventory-Adolescent Form', '114 nonclinical adolescents (ages 15 to 18) recruited from high schools in the Midwest who were randomly assigned to experimental groups', 'adults with less attention to adolescents']","['honest nonclinical, uncoached feigning, and coached feigning']","['Negative Impression Management (NIM) scale', 'clinical levels of depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031209', 'cui_str': 'Personality Assessment'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",50.0,0.0215101,"The Negative Impression Management (NIM) scale also demonstrated promise ( d  range = 0.77-1.08), while the smallest effects for detecting feigning were found for the Malingering Index ( d  range = 0.58-0.70).","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Malm', 'Affiliation': 'Peotone Community Unit School District 207-U, Peotone, IL, USA.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Pierson', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'W Holmes', 'Initials': 'WH', 'LastName': 'Finch', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Spengler', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'Department of Educational Psychology, Ball State University, Muncie, IN, USA.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Morey', 'Affiliation': 'Department of Psychological & Brain Sciences, Texas A&M University, College Station, TX, USA.'}]",Journal of personality assessment,['10.1080/00223891.2019.1693389']
803,31628456,Contrasting the Effects of Mortality Salience and Future Time Limitation on Goal Prioritization in Older and Younger Adults.,"OBJECTIVES


This study aims at contrasting the effects of limited future time perspective and mortality salience on goal prioritization across adulthood. Socioemotional selectivity theory (SST) argues that people increasingly prioritize emotionally meaningful goals when they perceive future time as more limited. Terror management theory (TMT) suggests that mortality salience (i.e., the awareness of one's mortality) drives people to prioritize the goal of perpetuating own existence through affirming cultural worldview.
METHOD


In this study, participants (N = 438) were randomly assigned to six conditions that primed (a) limited future time, (b) mortality salience, (c) death reflection, (d) both limited future time and mortality salience, (e) both limited future time, and death reflection, or (f) none.
RESULTS


Results showed that older adults allocated significantly more resources to emotionally close recipients who supported their cultural worldviews in conditions involving future time limitation and death reflection. They also allocated less resources to emotionally not close recipients who did not support their cultural worldviews in conditions involving future time limitation. Younger adults did not show these differences. Nor did mortality salience have any effect.
DISCUSSION


These results suggest that future time perspective and death reflection shift age-related goals more than mortality salience.",2020,"RESULTS


Results showed that older adults allocated significantly more resources to emotionally close recipients who supported their cultural worldviews in conditions involving future time limitation and death reflection.","['Older and Younger Adults', 'Younger adults', 'participants (N = 438']","['Socioemotional selectivity theory (SST', 'Mortality Salience and Future Time Limitation', 'Terror management theory (TMT']",['mortality salience'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",438.0,0.0283575,"RESULTS


Results showed that older adults allocated significantly more resources to emotionally close recipients who supported their cultural worldviews in conditions involving future time limitation and death reflection.","[{'ForeName': 'Helene H', 'Initials': 'HH', 'LastName': 'Fung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, New Territories.'}, {'ForeName': 'Steven Tsun-Wai', 'Initials': 'ST', 'LastName': 'Chu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, New Territories.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Special Education and Counselling, Education University of Hong Kong, New Territories.'}, {'ForeName': 'Amber Xuqian', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, New Territories.'}, {'ForeName': 'Carson Chuen', 'Initials': 'CC', 'LastName': 'Ng', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, New Territories.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz133']
804,29265857,Memory strength and lineup presentation moderate effects of administrator influence on mistaken identifications.,"Administrator/witness pairs (N = 313) were randomly assigned to target-absent lineups in a 2 (Suspect/Perpetrator Similarity: High Suspect Similarity vs. Low Suspect Similarity) × 2 (Retention Interval: 30 min vs. 1 week) × 2 (Lineup Presentation: Simultaneous vs. Sequential) × 2 (Administrator Knowledge: Single-Blind vs. Double-Blind) factorial design to test whether suspect similarity and memory strength constrain interpersonal expectancy effects on eyewitness identification accuracy. Administrators who knew which lineup member was the suspect (single-blind) or who administered simultaneous lineups were more likely to emit verbal and nonverbal behaviors that suggested to the witness who the suspect was. Additionally, single-blind administrators exerted more pressure on witnesses to choose the suspect as opposed to fillers. Administrator knowledge interacted with retention interval and lineup presentation to influence mistaken identifications of innocent suspects; witnesses were more likely to mistakenly identify an innocent suspect from single-blind than double-blind lineups when witness retention intervals were long and photographs were presented simultaneously. Contrary to our predictions, suspect/perpetrator similarity did not interact with other manipulated variables to influence identification decisions. Both sequential and double-blind procedures should be used to reduce the use of suggestive behavior during lineup administration. (PsycINFO Database Record",2017,"Contrary to our predictions, suspect/perpetrator similarity did not interact with other manipulated variables to influence identification decisions.",['Administrator/witness pairs (N = 313'],['target-absent lineups in a 2 (Suspect/Perpetrator Similarity: High Suspect Similarity vs. Low Suspect Similarity'],['emit verbal and nonverbal behaviors'],"[{'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C4517707', 'cui_str': '313'}]","[{'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",313.0,0.104486,"Contrary to our predictions, suspect/perpetrator similarity did not interact with other manipulated variables to influence identification decisions.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Psychology, John Jay College of Criminal Justice, City University of of New York.'}, {'ForeName': 'Jacqueline Austin', 'Initials': 'JA', 'LastName': 'Chorn', 'Affiliation': 'Department of Psychology, John Jay College of Criminal Justice, City University of of New York.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rhead', 'Affiliation': 'Department of Psychology, John Jay College of Criminal Justice, City University of of New York.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Evelo', 'Affiliation': 'Department of Psychology, John Jay College of Criminal Justice, City University of of New York.'}, {'ForeName': 'Margaret Bull', 'Initials': 'MB', 'LastName': 'Kovera', 'Affiliation': 'Department of Psychology, John Jay College of Criminal Justice, City University of of New York.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000147']
805,31461801,Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study.,"BACKGROUND


Various adjuvants were added to intrathecal anaesthetics to improve quality of the block and postoperative analgesia. We hypothesized that intrathecal dexmedetomidine and magnesium sulphate (MgSO 4  ) may add similar effects. Our objectives were to compare their effects as adjuvants to intrathecal bupivacaine on postoperative analgesia, stress hormones, sedative properties and the neonatal outcome after caesarean section.
METHODS


A randomized double-blind controlled study; 90 parturients were divided into three groups. All patients received intrathecal hyperbaric bupivacaine 12.5 mg. NaCl 0.9% was added to intrathecal block in group C, 5 μg dexmedetomidine in the group D and 50 mg MgSO 4  in group M. Visual analogue scale (VAS) score, stress hormones were assessed within the first 12 postoperative hours, sensory block, and neonatal outcome were also assessed.
RESULTS


VAS scores were significantly lower in groups D and M. Onset of postoperative pain was significantly prolonged in group D. Time to peak sensory level was shorter in group D. Sedation score was significantly higher in group D only after 30 min of intrathecal block. Although stress hormones increased in all groups during intraoperative and postoperative periods, their levels were significantly lower in group D compared to other groups. No differences were noted regarding neonatal outcomes.
CONCLUSION


Intrathecal dexmedetomidine is superior to intrathecal MgSO 4  during caesarean section with regard to duration of analgesia, pain severity and stress hormone levels. Dexmedetomidine has a rapid onset and longer duration of sensory block compared to MgSO 4  . No significant adverse effects to the parturients or newborns.",2020,"RESULTS


VAS scores were significantly lower in groups D & M. Onset of postoperative pain was significantly prolonged in group D. Time to peak sensory level was shorter in group D. Sedation score was significantly higher in group D only after 30 minutes of intrathecal block.",[' ninety parturients'],"['intrathecal hyperbaric bupivacaine', 'magnesium sulfate', 'Intrathecal dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine', 'intrathecal dexmedetomidine and magnesium sulfate (MgSO 4  ', 'intrathecal bupivacaine']","['postoperative analgesia, stress hormones, sedative properties and the neonatal outcome', 'peak sensory level', 'postoperative pain', 'stress hormones', 'VAS scores', 'Visual analogue scale (VAS) score, stress hormones', 'neonatal outcomes', 'adverse effects', 'duration of analgesia, pain severity, and stress hormone levels', 'postoperative analgesia and stress response', 'Sedation score']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",,0.255791,"RESULTS


VAS scores were significantly lower in groups D & M. Onset of postoperative pain was significantly prolonged in group D. Time to peak sensory level was shorter in group D. Sedation score was significantly higher in group D only after 30 minutes of intrathecal block.","[{'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Golnar M', 'Initials': 'GM', 'LastName': 'Fathy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Zein E A Zareh', 'Initials': 'ZEAZ', 'LastName': 'Hassan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Galal', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Talaat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed K', 'Initials': 'AK', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1476']
806,29172596,Overcoming the research-to-practice gap: A randomized trial with two brief homework and organization interventions for students with ADHD as implemented by school mental health providers.,"OBJECTIVE


To evaluate the effectiveness of 2 brief school-based interventions targeting the homework problems of adolescents with attention-deficit/hyperactivity disorder (ADHD)-the Homework, Organization, and Planning Skills (HOPS) intervention and the Completing Homework by Improving Efficiency and Focus (CHIEF) intervention, as implemented by school mental health providers during the school day. A secondary goal was to use moderator analyses to identify student characteristics that may differentially predict intervention response.
METHOD


Two-hundred and eighty middle school students with ADHD were randomized to the HOPS or CHIEF interventions or to waitlist, and parent and teacher ratings were collected pre, post, and at a 6-month follow-up.
RESULTS


Both interventions were implemented with fidelity by school mental health providers. Participants were pulled from elective periods and sessions averaged less than 20 min. Participants in HOPS and CHIEF demonstrated significantly greater improvements in comparison with waitlist on parent ratings of homework problems and organizational skills and effect sizes were large. HOPS participants also demonstrated moderate effect size improvements on materials management and organized action behaviors according to teachers. HOPS participants made significantly greater improvements in parent- and teacher-rated use of organized actions in comparison with CHIEF, but not on measures of homework problems. Moderation analyses revealed that participants with more severe psychopathology and behavioral dysregulation did significantly better with the HOPS intervention as compared to the CHIEF intervention.
CONCLUSIONS


Brief school-based interventions implemented by school providers can be effective. This type of service delivery model may facilitate overcoming the oft cited research-to-practice gap. (PsycINFO Database Record",2018,Participants in HOPS and CHIEF demonstrated significantly greater improvements in comparison with waitlist on parent ratings of homework problems and organizational skills and effect sizes were large.,"['adolescents with attention-deficit/hyperactivity disorder ', 'school mental health providers during the school day', 'Two-hundred and eighty middle school students with ADHD', 'students with ADHD as implemented by school mental health providers']","['HOPS or CHIEF interventions', 'HOPS', 'ADHD)-the Homework, Organization, and Planning Skills (HOPS) intervention and the Completing Homework by Improving Efficiency and Focus (CHIEF) intervention', 'homework and organization interventions', 'school-based interventions', 'HOPS intervention']","['materials management and organized action behaviors', 'parent- and teacher-rated use of organized actions', 'parent ratings of homework problems and organizational skills and effect sizes', 'severe psychopathology and behavioral dysregulation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0589042', 'cui_str': 'Organizational skills (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",280.0,0.0205773,Participants in HOPS and CHIEF demonstrated significantly greater improvements in comparison with waitlist on parent ratings of homework problems and organizational skills and effect sizes were large.,"[{'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Dvorsky', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Molitor', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Eddy', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Oddo', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Hana-May', 'Initials': 'HM', 'LastName': 'Eadeh', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000265']
807,31613706,A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function.,"Inadequate dietary fiber intake contributes to irregular bowel movements and may contribute to difficulty with defecation in children. Whole grain foods, such as oatmeal, may improve stool consistency and stool frequency in children; however, no studies have examined its effects. The purpose of this study was to investigate if 2 weeks of oatmeal consumption in children (ages 7-12 years) increases stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms. In this single-arm intervention study, children who reported ≤5 bowel movements per week during screening, consumed two servings of instant oatmeal daily for 2 weeks. The primary outcome was stool frequency and secondary outcomes included stool consistency and GI symptoms. Participants recorded bowel movements daily, food intake, and GI symptoms during baseline and 2 intervention weeks. Photos of the children's stool were taken at three timepoints during the study to assess stool consistency. In total, 33 children (15 female and 18 male) completed the study. Linear mixed models were used to detect change between baseline and the intervention weeks and accounted for repeated measures within subjects. No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008). The addition of oatmeal to children's diets is an effective way to increase fiber consumption and may reduce some GI symptoms such as gas, straining, and feeling of incomplete evacuation. Trial identification number: NCT02868515.",2020,"No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008).","['Children to Assess Markers of Bowel Function', 'children', '33 children (15 female and 18 male) completed the study', 'children (ages 7-12 years']",['Oatmeal Consumption'],"['stool consistency and stool frequency', 'stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms', 'stool frequency or consistency', 'stool consistency and GI symptoms', 'dietary fiber intake', 'bowel movements daily, food intake, and GI symptoms', 'stool frequency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0452680', 'cui_str': 'Oatmeal (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",33.0,0.133884,"No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008).","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Paruzynski', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korczak', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Clinical and Translational Science Institute, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Slavin', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0158']
808,29251953,Partner-related attachment as a moderator of outcome in patients with social anxiety disorder-a comparison between short-term cognitive-behavioral and psychodynamic therapy.,"This study investigated whether partner-related attachment characteristics differentially predict premature treatment termination as well as posttreatment and 1-year follow-up outcome in patients with social anxiety disorder treated with a manualized cognitive-behavioral therapy (CBT) or short-term psychodynamic therapy (PDT) in the SOPHO-NET (Social Phobia Psychotherapy Network) trial. Participants were 412 patients with social anxiety disorder (57% female) with a mean age of 35.4 years (SD = 12.1) who were randomized to either CBT or PDT. Partner-related attachment characteristics were measured using the revised Experiences in Close Relationships Questionnaire (ECR-R) at pretreatment. The Liebowitz Social Anxiety Scale was administered at pretreatment, posttreatment, and a 1-year follow-up. To address our research questions, linear regression models were applied. Furthermore, we compared CBT versus PDT patients within ECR-R quartiles. Treatment dropout did not differ between CBT and PDT and was not predicted by pretreatment attachment. In both treatment conditions, there was a trend for higher attachment anxiety to be associated with a more limited reduction in symptoms if controlling for pretreatment Liebowitz Social Anxiety Scale scores. Exploratory analyses showed that patients assigned to the highest quartile of the ECR-R-Avoidance distribution showed more benefit within the CBT condition posttreatment and at follow-up than the PDT condition. Our findings suggest that it may be useful to assess attachment characteristics in patients with social anxiety disorder before psychotherapeutic treatment. Patients characterized by very high pretreatment attachment avoidance (ECR-R-Avoidance >3.87) may specifically benefit more from CBT than from PDT. However, replication studies are needed that also should investigate nonlinear effects of pretreatment attachment. (PsycINFO Database Record",2017,"In both treatment conditions, there was a trend for higher attachment anxiety to be associated with a more limited reduction in symptoms if controlling for pretreatment Liebowitz Social Anxiety Scale scores.","['Participants were 412 patients with social anxiety disorder (57% female) with a mean age of 35.4 years (SD = 12.1', 'patients with social anxiety disorder treated with a', 'patients with social anxiety disorder-a comparison between', 'patients with social anxiety disorder before psychotherapeutic treatment']","['manualized cognitive-behavioral therapy (CBT) or short-term psychodynamic therapy (PDT', 'CBT or PDT', 'short-term cognitive-behavioral and psychodynamic therapy', 'CBT']","['higher attachment anxiety', 'Liebowitz Social Anxiety Scale', 'Liebowitz Social Anxiety Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1998305', 'cui_str': 'Short-term psychodynamic therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",412.0,0.0133933,"In both treatment conditions, there was a trend for higher attachment anxiety to be associated with a more limited reduction in symptoms if controlling for pretreatment Liebowitz Social Anxiety Scale scores.","[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Strauss', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, University Hospital Jena.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Koranyi', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, University Hospital Jena.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Altmann', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, University Hospital Jena.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nolte', 'Affiliation': 'The Anna Freud Centre.'}, {'ForeName': 'Manfred E', 'Initials': 'ME', 'LastName': 'Beutel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg University of Mainz.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Wiltink', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center, Johannes Gutenberg University of Mainz.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herpertz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL-University Clinic Bochum, Ruhr-University Bochum.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiller', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University of Mainz.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Hoyer', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Joraschky', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Technische Universitaet Dresden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Nolting', 'Affiliation': 'Psychosomatic Hospital.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stangier', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Goethe University Frankfurt.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Willutzki', 'Affiliation': 'Department of Psychology and Psychotherapy, University Witten/Herdecke.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Salzer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medicine, Georg-August-University Goettingen.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Leibing', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medicine, Georg-August-University Goettingen.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Leichsenring', 'Affiliation': 'University Hospital of Psychosomatics and Psychotherapy, Justus-Liebig-University Giessen.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Kirchmann', 'Affiliation': 'Institute of Psychosocial Medicine and Psychotherapy, University Hospital Jena.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000129']
809,29251954,Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up.,"Social anxiety disorder (SAD) is associated with considerable individual suffering and societal costs. Although there is ample evidence for the efficacy of cognitive behavior therapy, recent studies suggest psychodynamic therapy may also be effective in treating SAD. Furthermore, Internet-based psychodynamic therapy (IPDT) has shown promising results for addressing mixed depression and anxiety disorders. However, no study has yet investigated the effects of IPDT specifically for SAD. This paper describes a randomized controlled trial testing the efficacy of a 10-week, affect-focused IPDT protocol for SAD, compared with a wait-list control group. Long-term effects were also estimated by collecting follow-up data, 6, 12, and 24 months after the end of therapy. A total of 72 individuals meeting diagnostic criteria for DSM-IV social anxiety disorder were included. The primary outcome was the self-report version of Liebowitz Social Anxiety Scale. Mixed model analyses using the full intention-to-treat sample revealed a significant interaction effect of group and time, suggesting a larger effect in the treatment group than in the wait-list control. A between-group effect size Cohen's d = 1.05 (95% [CI]: [0.62, 1.53]) was observed at termination. Treatment gains were maintained at the 2-year follow-up, as symptom levels in the treated group continued to decrease significantly. The findings suggest that Internet-based affect-focused psychodynamic therapy is a promising treatment for social anxiety disorder. (PsycINFO Database Record",2017,"Treatment gains were maintained at the 2-year follow-up, as symptom levels in the treated group continued to decrease significantly.","['72 individuals meeting diagnostic criteria for DSM-IV social anxiety disorder were included', 'social anxiety disorder']","['Internet-based psychodynamic therapy (IPDT', 'Internet-based affect-focused psychodynamic therapy']","['symptom levels', 'Social anxiety disorder (SAD', 'self-report version of Liebowitz Social Anxiety Scale']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0222045'}]",72.0,0.0543575,"Treatment gains were maintained at the 2-year follow-up, as symptom levels in the treated group continued to decrease significantly.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Stockholm University.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesslow', 'Affiliation': 'Department of Psychology, Stockholm University.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Centre for Psychiatry Research, Karolinska Institutet.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Jansson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jonsson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University.'}, {'ForeName': 'Smilla', 'Initials': 'S', 'LastName': 'Färdig', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hesser', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Frederick', 'Affiliation': 'Center for Courageous Living.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lilliengren', 'Affiliation': 'Department of Psychology, Stockholm University.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000147']
810,29239644,The effects of team reflexivity on psychological well-being in manufacturing teams.,"While the impact of team reflexivity (a.k.a. after-event-reviews, team debriefs) on team performance has been widely examined, we know little about its implications on other team outcomes such as member well-being. Drawing from prior team reflexivity research, we propose that reflexivity-related team processes reduce demands, and enhance control and support. Given the centrality of these factors to work-based strain, we posit that team reflexivity, by affecting these factors, may have beneficial implications on 3 core dimensions of employee burnout, namely exhaustion, cynicism, and inefficacy (reduced personal accomplishment). Using a sample of 469 unskilled manufacturing workers employed in 73 production teams in a Southern Chinese factory, we implemented a time lagged, quasi-field experiment, with half of the teams trained in and executing an end-of-shift team debriefing, and the other half assigned to a control condition and undergoing periodic postshift team-building exercises. Our findings largely supported our hypotheses, demonstrating that relative to team members assigned to the control condition, those assigned to the reflexivity condition experienced a significant improvement in all 3 burnout dimensions over time. These effects were mediated by control and support (but not demands) and amplified as a function of team longevity. (PsycINFO Database Record",2018,"Our findings largely supported our hypotheses, demonstrating that relative to team members assigned to the control condition, those assigned to the reflexivity condition experienced a significant improvement in all 3 burnout dimensions over time.",['469 unskilled manufacturing workers employed in 73 production teams in a Southern Chinese factory'],"['teams trained in and executing an end-of-shift team debriefing, and the other half assigned to a control condition and undergoing periodic postshift team-building exercises']",[],"[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0033268'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0442614', 'cui_str': 'Factory (environment)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],469.0,0.0711752,"Our findings largely supported our hypotheses, demonstrating that relative to team members assigned to the control condition, those assigned to the reflexivity condition experienced a significant improvement in all 3 burnout dimensions over time.","[{'ForeName': 'Jingqiu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Antai College of Economics and Management, Shanghai Jiao Tong University.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Bamberger', 'Affiliation': 'Coller School of Management.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Warrington College of Business, University of Florida.'}, {'ForeName': 'Dana R', 'Initials': 'DR', 'LastName': 'Vashdi', 'Affiliation': 'Division of Public Administration and Policy, School of Political Sciences, University of Haifa.'}]",The Journal of applied psychology,['10.1037/apl0000279']
811,31604592,Influence of Narrow Femoral Implants on Intraoperative Soft Tissue Balance in Posterior-Stabilized Total Knee Arthroplasty.,"BACKGROUND


Narrow femoral implants were developed to improve fit and prevent overhang in primary total knee arthroplasty (TKA). We compared intraoperative soft tissue balance between standard and narrow implants in posterior-stabilized (PS) TKA.
METHODS


We enrolled 30 consecutive patients with varus osteoarthritis undergoing PS TKA using an image-free navigation system. Standard and narrow femoral trial implants were inserted, and their soft tissue balance was measured. Subgroup analysis, based on the actual implanted femoral implant, was performed to assess the influence of narrow implants on soft tissue balance.
RESULTS


Narrow trial group had significantly larger joint component gaps than standard trial group at all measured flexion angles, except at 60° (P < .05). For the standard implant cohort, narrow trial group had significantly larger joint component gaps than standard trial group at 30°, 120°, and 135° flexion (P < .05). For the narrow implant cohort, narrow trial group had significantly larger joint component gaps than standard trial group at all measured flexion angles, except at 0° and 60° (P < .05). Narrow trial group had significantly larger varus ligament balance than standard trial group at 45° and 60° flexion (P < .05). The varus angles for standard implants were comparable between groups; however, narrow trial group had significantly larger varus angles for narrow implants than standard trial group at 45°, 60°, and 120° flexion (P < .05).
CONCLUSION


The medial-lateral dimension and volume of the femoral component may influence intraoperative soft tissue balance in PS TKA. The effects may be greater when narrow implants are selected to avoid component overhang.",2020,"The varus angles for standard implants were comparable between groups; however, narrow trial group had significantly larger varus angles for narrow implants than standard trial group at 45°, 60°, and 120° flexion (P < .05).
","['Posterior-Stabilized Total Knee Arthroplasty', '30 consecutive patients with varus osteoarthritis undergoing PS TKA using an image-free navigation system']",['Narrow Femoral Implants'],"['larger joint component gaps', 'larger varus angles', 'Intraoperative Soft Tissue Balance', 'larger varus ligament balance']","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}]","[{'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0450436', 'cui_str': 'Joint component (attribute)'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023685', 'cui_str': 'Ligaments'}]",30.0,0.0792686,"The varus angles for standard implants were comparable between groups; however, narrow trial group had significantly larger varus angles for narrow implants than standard trial group at 45°, 60°, and 120° flexion (P < .05).
","[{'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Department of Orthopaedic Surgery, Kobe Kaisei Hospital, Nada, Kobe, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shibanuma', 'Affiliation': 'Department of Orthopaedic Surgery, Kobe Kaisei Hospital, Nada, Kobe, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Department of Orthopaedic Surgery, Kobe Kaisei Hospital, Nada, Kobe, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takayama', 'Affiliation': 'Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Chuo, Kobe, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Kuroda', 'Affiliation': 'Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Chuo, Kobe, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Chuo, Kobe, Japan.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.055']
812,29131887,"Effect of an Intervention to Promote Breastfeeding on Asthma, Lung Function, and Atopic Eczema at Age 16 Years: Follow-up of the PROBIT Randomized Trial.","Importance


Atopic diseases, including asthma and atopic eczema, are the most common chronic conditions of childhood.
Objective


To investigate whether an intervention to promote prolonged and exclusive breastfeeding protects against asthma, atopic eczema, and low lung function in adolescence.
Design, Setting, and Participants


Follow-up of the Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster randomized trial in 30 Belarusian maternity hospitals and affiliated polyclinics; recruitment of 17 046 healthy term infants took place from June 15, 1996, to December 31, 1997. Data analysis was conducted from May 9, 2016, to April 21, 2017. The primary analytic approach was by modified intention-to-treat analysis.
Interventions


Randomization to receive a breastfeeding promotion intervention vs usual care.
Main Outcomes and Measures


Spirometry and flexural eczema on standardized skin examination by study pediatricians were the primary outcomes; secondary outcomes were self-reported asthma diagnosis ever, and wheezing and flexural eczema symptoms in the previous year.
Results


A total of 13 557 (79.5%) participants were followed up from September 15, 2012 to July 15, 2015. The intervention (7064 [79.7%]) and control (6493 [79.4%]) groups were similar at follow-up (3590 [50.8%] and 3391 [52.2%] male; mean [SD] age, 16.2 [0.6] and 16.1 [0.5] years, respectively). In the intervention group, 0.3% (21 of 7064) had flexural eczema on skin examination and mean (SD) forced expiratory volume in the first second of expiration/forced vital capacity (FEV1/FVC) ratio z score was -0.10 (1.82), compared with 0.7% (43 of 6493) and 0.35 (1.34), respectively, in the control group. In modified intention-to-treat analysis, accounting for clustering by polyclinic, a 54% lower risk of flexural eczema on skin examination was observed in the intervention compared with the control group (odds ratio [OR], 0.46; 95% CI, 0.25 to 0.86). Self-reported flexural eczema symptoms in the past year (OR, 0.57; 95% CI, 0.27 to 1.18), asthma (OR, 0.76; 95% CI, 0.47 to 1.23), and wheezing in the past year (OR, 0.66; 95% CI, 0.37 to 1.18) were less frequently reported in the intervention compared with the control group, but 95% CIs were wide and included the null. There was no significant difference in the FEV1/FVC ratio z score (β -0.15; 95% CI, -0.76 to 0.45). All results were similar with additional adjustment for baseline characteristics, on instrumental variable analysis, and with multiple imputation among all 17 046 randomized participants.
Conclusions and Relevance


A breastfeeding promotion intervention reduced flexural dermatitis risk but had no detectable effect on lung function or questionnaire-derived measures of atopic eczema or asthma in adolescence in a setting where atopic eczema and allergies are rare.
Trial Registration


clinicaltrials.gov Identifier: NCT01561612.",2018,"In the intervention group, 0.3% (21 of 7064) had flexural eczema on skin examination and mean (SD) forced expiratory volume in the first second of expiration/forced vital capacity","['groups were similar at follow-up (3590 [50.8%] and 3391 [52.2%] male; mean [SD] age, 16.2 [0.6] and 16.1 [0.5] years, respectively', 'A total of 13\u202f557 (79.5%) participants were followed up from September 15, 2012 to July 15, 2015', 'on Asthma, Lung Function, and Atopic Eczema at Age 16 Years', '30 Belarusian maternity hospitals and affiliated polyclinics; recruitment of 17\u202f046 healthy term infants took place from June 15, 1996, to December 31, 1997']","['breastfeeding promotion intervention vs usual care', 'Intervention to Promote Breastfeeding']","['FEV1/FVC) ratio z score', 'FEV1/FVC ratio z score', 'flexural dermatitis risk', 'self-reported asthma diagnosis ever, and wheezing and flexural eczema symptoms', 'flexural eczema symptoms', 'flexural eczema on skin examination and mean (SD) forced expiratory volume in the first second of expiration/forced vital capacity', 'Measures\n\n\nSpirometry and flexural eczema on standardized skin examination', 'flexural eczema on skin examination']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517801', 'cui_str': '52.2 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439748', 'cui_str': 'Flexural (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0263224', 'cui_str': 'Flexural eczema (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",17046.0,0.127833,"In the intervention group, 0.3% (21 of 7064) had flexural eczema on skin examination and mean (SD) forced expiratory volume in the first second of expiration/forced vital capacity","[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Division of Genetics and Molecular Medicine, King's College London and Guy's & St Thomas' National Health Service Foundation Trust, London, England.""}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Henderson', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, England.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Quebec, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, England.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Rifas-Shiman', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Quebec, Canada.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vilchuck', 'Affiliation': 'National Research and Applied Medicine Mother and Child Centre, Minsk, Republic of Belarus.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bogdanovich', 'Affiliation': 'National Research and Applied Medicine Mother and Child Centre, Minsk, Republic of Belarus.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Hameza', 'Affiliation': 'National Research and Applied Medicine Mother and Child Centre, Minsk, Republic of Belarus.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, England.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2017.4064']
813,31433893,"The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study.","OBJECTIVE


The aim of this randomized controlled trial was to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumours.
METHODS


This trial included 89 patients with chest malignancies, scheduled for thoracotomy were randomly allocated into two groups: Group A ""PCA-group N=44"" receiving patient-controlled analgesia and group B ""SAPB group N=45"" where analgesia was provided by SAPB. The primary outcome measure was the assessment for the possible emergence of PTPS at 12 weeks. The secondary outcome measures were pain relief measured using visual analog scale (VAS) score, Quality of life was assessed using Flanagan Quality of Life Scale (QOLS) and Activity level was assessed using Barthel Activity of daily living (ADL) score.
RESULTS


At week 8, PTPS incidence was significantly (p = .037) higher in the PCA group (45%) than in the SAPB group (24%) with a relative risk of 1.38 and 95% CI (1.01-1.9) while the incidence of PTPS at week 12 was significantly (p = .035) higher in the PCA group (43%) than in the SAPB group (22%) with a relative risk of 2.38 and 95% CI (1.23-4.57). The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than the PCA group (38.6%) (p = .028) at week 12. Pain intensity: VAS-R and VAS-D (pain scores at rest and with activity, respectively) was comparable (p > .05) between both groups at 6, 12, 18 and 24 hr, however VAS was significantly higher in the PCA group at week 8 (p = .046) and week 12 (p = .032) . Both groups were comparable regarding ADL and QOL scores (p > .05).
CONCLUSION


Serratus anterior plane block is assumed to be a good alternative for post-thoracotomy analgesia following thoracotomies. The current work hypothesized that SAPB for a week postoperatively, may reduce the emergence of PTPS and may reduce the demand for pain therapy in those patients.
SIGNIFICANCE STATEMENT


The current work hypothesized that SAPB for a week postoperatively, is a good loco-regional alternative for post-thoracotomy analgesia following thoracotomies for chest malignancies, it may reduce the emergence of PTPS and the demand for pain therapy in these patients.",2020,The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than PCA group (38.6%) (P= 0.028) at week 12.,"['89 patients with chest malignancies, scheduled for thoracotomy', 'post-thoracotomy pain syndrome', 'post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumors']","['ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia', 'PCA', 'U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA', 'PCA-group N=44"" receiving patient-controlled analgesia and group B ""SAPB group N=45"" where analgesia was provided by serratus anterior plane catheter block']","['ADL and QOL scores', 'PTPS incidence', 'incidence of PTPS', 'need for pain therapy', 'VAS', 'Pain intensity: VAS-R and VAS-D (pain scores', 'pain relief measured by visual analog scale (VAS) score, Quality of life was assessed by Flanagan Quality of Life Scale (QOLS) and Activity level', 'Barthel Activity of daily living (ADL) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0406844', 'cui_str': 'Post-thoracotomy pain syndrome (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0284927', 'cui_str': 'PTPS'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034380'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",89.0,0.138435,The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than PCA group (38.6%) (P= 0.028) at week 12.,"[{'ForeName': 'Raafat M', 'Initials': 'RM', 'LastName': 'Reyad', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ehab H', 'Initials': 'EH', 'LastName': 'Shaker', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam Z', 'Initials': 'HZ', 'LastName': 'Ghobrial', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dina N', 'Initials': 'DN', 'LastName': 'Abbas', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Reyad', 'Affiliation': 'Department of Clinical Pathology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.'}, {'ForeName': 'Abd Alrahman M', 'Initials': 'AAM', 'LastName': 'Abd Alrahman', 'Affiliation': 'Department of Surgical Oncology, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Al-Demery', 'Affiliation': 'Department of Surgical Oncology, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Emad R H', 'Initials': 'ERH', 'LastName': 'Issak', 'Affiliation': 'Neuropsychiatry Researcher, ClinAmygate, Cairo, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1473']
814,31599809,Neoadjuvant Radiotherapy Versus Surgery Alone for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors: A Prospective Multicenter Stratified Randomized Trial.,"OBJECTIVE


The aim of this study was to compare stage II/III rectal cancers with or without high-risk factors, and evaluate the effect of neoadjuvant radiotherapy (NRT) in these 2 cohorts.
BACKGROUND


NRT is often used in stage II/III rectal cancers to improve local control, while not affecting overall survival. However, good-quality surgery without NRT may also achieve good local control in selected patients.
METHODS


According to risk-stratification criteria and clinical staging, consecutive eligible participants of stage II/III rectal cancer were preoperatively classified into patients with (high-risk) or without (low-risk) high-risk factors. Both groups were respectively randomized to receive either short-course radiotherapy (SCRT) + total mesorectal excision (TME) or TME alone, forming the following 4 groups: high-risk patients with (HiR) or without (HiS) radiation, and low-risk patients with (LoR) or without (LoS) radiation. The primary endpoint was local recurrence. The secondary endpoints included overall survival, disease-free survival, distant recurrence, quality of surgery, and safety (NCT01437514).
RESULTS


In total, 401 patients were analyzed. With a median 54 months' follow-up, low-risk patients obtained better 3-year cumulative incidence of local recurrence (2.2% vs 11.0%, P = 0.006), overall survival rate (86.9%vs 76.5%, P = 0.002), disease-free survival rate (87.0% vs 67.9%, P < 0.001), and cumulative incidence of distant recurrence (12.5% vs 29.4%, P < 0.001) than high-risk patients. With regard to 3-year cumulative incidence of local recurrence, no differences were observed between the LoR and LoS groups (1.2% vs 3.0%, P = 0.983) or the HiR and HiS groups (12.9% vs 8.9%, P = 0.483).
CONCLUSIONS AND RELEVANCE


Stratification of stage II/III rectal cancers according to risk factors to more precise subclassifications may result in noteworthy differences in survivals and local pelvic control. An extremely low cumulative incidence of local recurrence and survivals in low-risk patients can be achieved with upfront good quality of surgery alone. This trial, owing to the insufficient power, could not prove the noninferiority of surgery alone, but suggest a discriminative use of NRT according to clinical risk stratification in stage II/III rectal cancer.",2020,"With regard to 3-year cumulative incidence of local recurrence, no differences were observed between the LoR and LoS groups (1.2% vs 3.0%, P = 0.983) or the HiR and HiS groups (12.9% vs 8.9%, P = 0.483).
","['low-risk patients', 'consecutive eligible participants of stage II/III rectal cancer were preoperatively classified into patients with (high-risk) or without (low-risk) high-risk factors', '401 patients were analyzed', 'Stage II/III Mid-Low Rectal Cancer']","['neoadjuvant radiotherapy (NRT', 'Neoadjuvant Radiotherapy Versus Surgery Alone', 'short-course radiotherapy (SCRT) + total mesorectal excision (TME) or TME alone, forming the following 4 groups: high-risk patients with (HiR) or without (HiS) radiation, and low-risk patients with (LoR) or without (LoS) radiation']","['overall survival, disease-free survival, distant recurrence, quality of surgery, and safety (NCT01437514', '3-year cumulative incidence of local recurrence', 'disease-free survival rate', 'overall survival rate', 'local recurrence', 'local recurrence and survivals', 'cumulative incidence of distant recurrence']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",401.0,0.152888,"With regard to 3-year cumulative incidence of local recurrence, no differences were observed between the LoR and LoS groups (1.2% vs 3.0%, P = 0.983) or the HiR and HiS groups (12.9% vs 8.9%, P = 0.483).
","[{'ForeName': 'Xiangbing', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Colorectal Cancer Clinical Research Center, The Third Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mingtian', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Abdominal Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xuyang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuanchuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of General Surgery, The Third People's Hospital of Chengdu, Chengdu, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of General Surgery, The Third People's Hospital of Chengdu, Chengdu, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'Department of Abdominal Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhuang', 'Affiliation': 'Department of Ultrasound, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zongguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Colorectal Cancer Clinical Research Center, The Third Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Department of Abdominal Cancer, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu, China.'}]",Annals of surgery,['10.1097/SLA.0000000000003649']
815,31603191,Personalized antiplatelet therapy guided by a novel detection of platelet aggregation function in stable coronary artery disease patients undergoing percutaneous coronary intervention: a randomized controlled clinical trial.,"AIMS


A number of studies have attempted to demonstrate the benefits associated with personalized antiplatelet therapy guided by platelet function testing, which has led to disappointing findings. In this study, we used a new platelet function test to guide antiplatelet therapy in stable coronary artery disease (CAD) patients after percutaneous coronary intervention (PCI).
METHODS AND RESULTS


In the present randomized controlled trial, a total of 2237 patients with stable CAD undergoing PCI were randomly chosen to be administered personalized antiplatelet therapy (personalized group; n = 1123) or standard antiplatelet treatment (standard group; n = 1114). The patients in the standard therapy group, without detecting the platelet aggregation rate, were administered a 75 mg/day clopidogrel maintenance dosage plus 100 mg/day of aspirin for at least 6 months after the procedure. For the patients in the personalized therapy group, the antiplatelet strategy was performed according to the maximum aggregation rate (MAR), determined using a novel platelet analyser, PL-12. If MAR > 55%, 90 mg ticagrelor was administered twice daily plus 100 mg/day of aspirin after PCI. If MAR ≤55%, 75 mg/day clopidogrel plus 100 mg/day of aspirin was administered after PCI. The primary endpoint was net clinical adverse events, which were a composite of cardiac death, myocardial infarction, stroke, stent thrombosis, urgent revascularization, and bleeding [Bleeding Academic Research Consortium (BARC) definitions, Type 2, 3, or 5], in the 180-day period after randomization. The primary endpoint was reached in 58 patients in the personalized group, compared with 85 patients in the standard group [5.1% vs. 7.5%, hazard ratio (HR) 0.678, 95% confidence interval (CI) 0.486-0.947, P = 0.023], on intention-to-treat analysis. We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR 0.510, 95% CI 0.284-0.915, P = 0.020). We did not find a significant difference in major bleeding events at either the 30-day (0.5% vs. 0.3%, P = 0.322) or the 180-day follow-up (2.1% vs. 1.6%, P = 0.364) between the two groups.
CONCLUSION


The present study suggests that personalized antiplatelet therapy according to MAR can significantly improve the net clinical benefit 180 days after PCI.",2020,"We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR: 0.510, 95% CI: 0.284-0.915, P = 0.020).","['stable coronary artery disease patients undergoing PCI', '2237 patients with stable coronary artery disease (CAD) undergoing PCI', 'stable CAD patients after PCI']","['ticagrelor', 'clopidogrel maintenance dosage plus 100\u2009mg/day of aspirin', 'personalized antiplatelet therapy (personalized group; n\u2009=\u20091123) or standard antiplatelet treatment', 'aspirin']","['net clinical adverse events, which were a composite of cardiac death, myocardial infarction (MI), stroke, stent thrombosis, urgent revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5', 'net clinical adverse events (including ischaemic and bleeding events', 'maximum aggregation rate (MAR', 'major bleeding events', 'platelet aggregation rate']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0430991', 'cui_str': 'Mixed antiglobulin test for sperm (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}]",2237.0,0.0964211,"We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR: 0.510, 95% CI: 0.284-0.915, P = 0.020).","[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xian-Geng', 'Initials': 'XG', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Cadre Ward, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi-Ning', 'Initials': 'YN', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz059']
816,29251978,"Customized recommendations and reminder text messages for automated, computer-based treatment during methadone.","The Recovery Line is an automated, computer-based intervention based on cognitive behavioral therapy (CBT) designed to provide real-time assistance by phone for patients in methadone maintenance. Preliminary efficacy findings were promising, however, as with other computer-based systems for substance use disorder, patient system use was less than recommended. Development and evaluation of system functions to increase patient engagement and use is needed. Thus, we conducted two randomized trials to evaluate system functions designed to increase patient use of the Recovery Line among methadone-maintained patients with continued illicit drug use. In Trial 1 (n = 60), patients received customized, system use recommendations or no recommendations on each Recovery Line call. Ratings of system usability were higher for customized recommendations (CR), but number of calls and total call time did not differ by condition. Trial 2 evaluated characteristics of reminder messages (message frame and reminder latency). Participants (N = 67) received gain- and loss-frame reminder messages, and were randomly assigned to immediate, short, or long term message latency. Although message framing had no effect, gender interacted with latency condition such that females did not differ by message latency, while males had significantly greater total contact time in the short latency conditions. Number of calls differed by condition over time such that the shorter latencies led to greater calls initially, but dissipated over time. Overall the study indicates that computer-based self-management systems can be adapted to increase patient engagement and use. (PsycINFO Database Record",2017,"Ratings of system usability were higher for customized recommendations (CR), but number of calls and total call time did not differ by condition.","['Participants (N = 67) received', 'maintained patients with continued illicit drug use']","['cognitive behavioral therapy (CBT', 'methadone', 'gain- and loss-frame reminder messages', 'customized, system use recommendations or no recommendations on each Recovery Line call']","['number of calls and total call time', 'total contact time', 'Ratings of system usability']","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0281875', 'cui_str': 'Illicit drug use (finding)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",,0.0411417,"Ratings of system usability were higher for customized recommendations (CR), but number of calls and total call time did not differ by condition.","[{'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}, {'ForeName': 'Frank D', 'Initials': 'FD', 'LastName': 'Buono', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}, {'ForeName': 'Destiny M B', 'Initials': 'DMB', 'LastName': 'Printz', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Lloyd', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Schottenfeld', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}, {'ForeName': 'Declan T', 'Initials': 'DT', 'LastName': 'Barry', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000149']
817,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
818,31563397,Efficacy of Systemic Steroid Use Given One Day After Total Knee Arthroplasty for Pain and Nausea: A Randomized Controlled Study.,"BACKGROUND


Systemic steroid has been used to control pain and nausea in total knee arthroplasty (TKA), but most studies recommend a single dose administration prior to, or during, surgery. This study aimed to determine the efficacy of administration on 1 day postoperatively.
METHODS


Patients who were scheduled to undergo TKA were randomly assigned to the following groups: control group, receiving normal saline injection; group 1, receiving 10 mg dexamethasone intravenously (IV) 1 hour before surgery; group 2, receiving 0.1 mg/kg dexamethasone (IV) 24 hours after surgery; or group 3, receiving 0.2 mg/kg dexamethasone (IV) 24 hours after surgery (n = 44-46 per group). Primary outcomes were pain and nausea visual analogue scale (VAS). Secondary outcomes were analgesic administration, rescue antiemetic administration, C-reactive protein, range of motion, and complications.
RESULTS


Postoperative pain and nausea remained high for 48 hours post-TKA. Group 1 had lower pain and nausea VAS scores than did the control group (P < .01) for only 24 hours post-TKA. Groups 2 and 3 had lower pain and nausea VAS scores than did the control group and group 1 (P < .01) 48 hours post-TKA. Analgesic and antiemetic administration were significantly lower in groups 2 and 3 than in the control group during 48 hours after TKA. There were no differences in C-reactive protein level and range of motion, and complications were not detected.
CONCLUSION


The effect of preoperative and postoperative administration of dexamethasone for controlling pain and nausea was observed only for 24 hours. Considering that severe pain and nausea persisted for more than 48 hours after TKA, additional administration of dexamethasone at 1 day postoperatively is suggested.
LEVEL OF EVIDENCE


Level I.",2020,Analgesic and antiemetic administration were significantly lower in groups 2 and 3 than in the control group during 48 hours after TKA.,"['Patients who were scheduled to undergo TKA', 'total knee arthroplasty (TKA']","['dexamethasone (IV', 'Total Knee Arthroplasty', 'dexamethasone', 'control group, receiving normal saline injection; group 1, receiving 10 mg dexamethasone intravenously (IV', 'Systemic Steroid Use Given One Day']","['C-reactive protein level and range of motion, and complications', 'pain and nausea', 'pain and nausea visual analogue scale (VAS', 'analgesic administration, rescue antiemetic administration, C-reactive protein, range of motion, and complications', 'Analgesic and antiemetic administration', 'lower pain and nausea VAS scores', 'Postoperative pain and nausea', 'Pain and Nausea', 'pain and nausea VAS scores', 'severe pain and nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",,0.186059,Analgesic and antiemetic administration were significantly lower in groups 2 and 3 than in the control group during 48 hours after TKA.,"[{'ForeName': 'Jong-Keun', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Hanil General Hospital, Seoul, South Korea.'}, {'ForeName': 'Du Hyun', 'Initials': 'DH', 'LastName': 'Ro', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Han-Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Hanil General Hospital, Seoul, South Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myung Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.026']
819,31487415,How and for whom does a positive affect intervention work in fibromyalgia: An analysis of mediators and moderators.,"OBJECTIVES


Psychological interventions designed to enhance positive affect are promising ways to promote adaptive functioning in people with chronic pain. However, few studies have addressed the efficacy of positive affect interventions in chronic pain populations and examined which patients can benefit more from them. The aim of the present study was to identify mediators and moderators of the best possible self intervention (BPS) in fibromyalgia patients.
METHODS


We used data from a previous randomized controlled trial that examined changes in pain interference, depression, self-efficacy and quality of life after the BPS intervention.
RESULTS


Mediation analyses showed that depression mediated changes in pain interference. Positive and negative affect were significant mediators of the change in depression and quality of life. No significant mediators of the change in self-efficacy were found. Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology.
DISCUSSION


In fibromyalgia patients, the effects of the BPS on the outcomes seem to be more related to changes in affect than to changes in future expectations.
SIGNIFICANCE


This study presents evidence about who can benefit from an intervention designed to augment positive affect and promote positive functioning in FMS patients and how these changes occur. It extends previous findings on patient characteristics associated with the response to pain management interventions.",2020,"Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology.
","['people with chronic pain', 'fibromyalgia', 'fibromyalgia patients']",['self intervention (BPS'],"['Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination', 'depressive symptomatology', 'depression and quality of life', 'pain interference, depression, self-efficacy, and quality of life', 'self-efficacy', 'pain interference']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0971719,"Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology.
","[{'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Molinari', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Miragall', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Enrique', 'Affiliation': 'Trinity College, School of Psychology, Dublin, Ireland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}]","European journal of pain (London, England)",['10.1002/ejp.1481']
820,31594401,Can an app a day keep illiteracy away? Piloting the efficacy of Reading Doctor apps for preschoolers with developmental language disorder.,"Purpose:  This study investigated the efficacy of three Reading Doctor ®  (RD) apps in raising letter-sound aptitude, phoneme awareness and early decoding ability among children with heightened risk for reading difficulties due to developmental language disorder (DLD). Method:  Twenty-four 4-year-old children with DLD, identified through baseline speech-language assessments, in their final term of pre-school participated in this study. In the experimental condition, 14 children participated twice a week in three RD apps for 8 weeks. In the control condition, 10 children engaged in their usual pre-school programme inclusive of teacher-delivered small-group activities related to letters and sounds taught in a non-systematic and non-explicit fashion. Result:  No significant between-group differences were identified prior to the implementation of RD. Following instruction, pre-school children in the experimental condition performed significantly better than children in the control condition in phoneme blending ( p  < 0.001,  d =  1.86), phoneme segmentation ( p  < 0.001,  d =  1.15) and letter-sound recognition ( p<  0.001,  d =  1.92), as well as in the number of correct phoneme-grapheme conversions during early decoding attempts ( p =  0.025,  d =  1.08). Conclusion:  Initial evidence suggests that RD software may support code-based reading readiness among pre-school children with DLD prior to school entry.",2020,"Following instruction, pre-school children in the experimental condition performed significantly better than children in the control condition in phoneme blending ( p  < 0.001,  d =  1.86), phoneme segmentation ( p  < 0.001,  d =  1.15) and letter-sound recognition ( p<  0.001,  d =  1.92), as well as in the number of correct phoneme-grapheme conversions during early decoding attempts ( p =  0.025,  d =  1.08).  ","['preschoolers with developmental language disorder', 'pre-school children with DLD prior to school entry', '10 children engaged in their usual pre-school programme inclusive of', 'Method:  Twenty-four 4-year-old children with DLD, identified through baseline speech-language assessments, in their final term of pre-school participated in this study', 'children with heightened risk for reading difficulties due to developmental language disorder (DLD']","['three Reading Doctor ®  (RD', 'teacher-delivered small-group activities related to letters and sounds taught in a non-systematic and non-explicit fashion']","['letter-sound recognition', 'phoneme segmentation']","[{'cui': 'C0023014', 'cui_str': 'Speech or Language, Developmental Disorder'}, {'cui': 'C0424930', 'cui_str': 'Pre-school (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0220922', 'cui_str': 'systematics'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}]",14.0,0.0180509,"Following instruction, pre-school children in the experimental condition performed significantly better than children in the control condition in phoneme blending ( p  < 0.001,  d =  1.86), phoneme segmentation ( p  < 0.001,  d =  1.15) and letter-sound recognition ( p<  0.001,  d =  1.92), as well as in the number of correct phoneme-grapheme conversions during early decoding attempts ( p =  0.025,  d =  1.08).  ","[{'ForeName': 'Karyn L', 'Initials': 'KL', 'LastName': 'Carson', 'Affiliation': 'College of Education, Psychology and Social Work, Flinders University, Adelaide, Australia.'}]",International journal of speech-language pathology,['10.1080/17549507.2019.1667438']
821,28885392,The Effect of External Thermomechanical Stimulation and Distraction on Reducing Pain Experienced by Children During Blood Drawing.,"This study aimed to investigate the sole and combined effects of external thermomechanical stimulation and distraction in pain relief of children during blood drawing.This is a randomized clinical trial. The sample consisted of 218 children aged 6 to 12 years who were randomly assigned to 4 groups: group 1 received no intervention, group 2 received external thermomechanical stimulation using Buzzy, group 3 received distraction via DistrACTION Cards, and group 4 received a combination of both external thermomechanical stimulation and distraction. Preprocedural anxiety was assessed through observers' observations using the Children's Anxiety and Pain Scale. Children's pain levels were assessed by themselves, observers, and parents, as reported using the Faces Pain Scale-Revised. Preprocedural anxiety did not differ significantly (P > 0.05). When the 3 study groups were compared with the control group, all 3 groups had significantly lower pain levels than the control group (P < 0.001). The lowest pain level was measured in the combined condition (Buzzy and DistrACTION Cards). The mean score of the device group was lower than the distraction group.",2020,"When the 3 study groups were compared with the control group, all 3 groups had significantly lower pain levels than the control group (P < 0.001).","['218 children aged 6 to 12 years', 'by Children', 'pain relief of children during blood drawing']","['external thermomechanical stimulation and distraction', 'no intervention, group 2 received external thermomechanical stimulation using Buzzy, group 3 received distraction via DistrACTION Cards, and group 4 received a combination of both external thermomechanical stimulation and distraction', 'External Thermomechanical Stimulation and Distraction']","['Preprocedural anxiety', 'lowest pain level', ""Children's Anxiety and Pain Scale"", 'mean score', ""Children's pain levels"", 'pain levels', 'Pain Experienced']","[{'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",218.0,0.0378371,"When the 3 study groups were compared with the control group, all 3 groups had significantly lower pain levels than the control group (P < 0.001).","[{'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Inal', 'Affiliation': 'From the Faculty of Health Sciences, Istanbul University, Istanbul.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Kelleci', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Cumhuriyet University, Sivas, Turkey.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001264']
822,31592728,Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial.,"BACKGROUND


In patients with acute deep vein thrombosis (DVT), pharmacomechanical catheter-directed thrombolysis (PCDT) in conjunction with anticoagulation therapy is increasingly used with the goal of preventing postthrombotic syndrome. Long-term costs and cost-effectiveness of these 2 treatment strategies from the perspective of the US healthcare system have not been compared.
METHODS AND RESULTS


Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis) randomized 692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355). Costs (2017 US dollars) were assessed over a 24-month follow-up period using a combination of resource-based costing, hospital bills, Medicare reimbursement rates, and the Drug Topics Red Book. Health state utilities were obtained from the Short Form-36. In-trial results and US life tables were used to develop a Markov cohort model to evaluate lifetime cost-effectiveness. For the PCDT group, mean costs of the initial procedure were $13 600; per-patient costs associated with the index hospitalization were $21 509 for PCDT and $3877 for standard care (difference=$17 632; 95% CI, $16 117-$19 243). The 24-month difference in costs was $20 045 (95% CI, $16 093-$24 120). Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point. Projected differences in lifetime costs of $16 740 and quality-adjusted life years (QALYs) of 0.08, yield an incremental cost-effectiveness ratio for PCDT of $222 041/QALY gained. In probabilistic sensitivity analysis, the probability that PCDT would achieve a lifetime incremental cost-effectiveness ratio <$50 000/QALY or <$150 000/QALY was 1% and 25%, respectively. For iliofemoral DVT, QALY gains with PCDT were greater, yielding an incremental cost-effectiveness ratio of $137 526/QALY; for femoral-popliteal DVT, standard therapy was an economically dominant strategy.
CONCLUSIONS


With an incremental cost-effectiveness ratio >$200 000/QALY gained, PCDT is not an economically attractive treatment for proximal DVT. PCDT may be of intermediate value in patients with iliofemoral DVT. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00790335.",2019,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","['patients with iliofemoral DVT', 'Between 2009 and 2014, the ATTRACT trial (Acute Venous Thrombosis', 'patients with acute deep vein thrombosis (DVT', '692 patients with acute proximal DVT to PCDT plus anticoagulation (n=337) or standard treatment with anticoagulation alone (n=355', 'Patients With Proximal Deep Vein Thrombosis']","['Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis', 'Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'PCDT']","['costs', 'Cost-Effectiveness', 'Utility scores', 'mean costs of the initial procedure', 'lifetime costs', 'Health state utilities', 'index hospitalization', 'incremental cost-effectiveness ratio for PCDT', 'lifetime incremental cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",692.0,0.13536,"Utility scores increased significantly between baseline and 6 months for both groups, with no significant differences between groups at any follow-up time point.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Khaja', 'Initials': 'K', 'LastName': 'Chinnakondepalli', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute (C.K.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology (J.A.J.), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Jewish General Hospital, Lady Davis Institute, Center for Clinical Epidemiology, Montreal, QC, Canada (S.R.K.).'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (S.Z.G.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Newton-Wellesley Hospital, Newton, MA (M.R.J.).'}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (A.L.K.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Herman', 'Affiliation': 'Interventional Institute at Holy Name Medical Center, Teaneck, NJ (K.H.).'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Brady', 'Affiliation': 'Thomas Jefferson University and Einstein Health Care Network, Philadelphia, PA (P.S.B.).'}, {'ForeName': 'Karun', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': ""Children's National Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC (K.S.).""}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Black', 'Affiliation': 'Utah Valley Hospital/Intermountain Healthcare and IVC Vein and Interventional Center, Provo (C.M.B.).'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, MO (S.V.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (E.A.M., K.C., K.V., D.J.C.).""}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005659']
823,29251975,Contingency management targeting abstinence is effective in reducing depressive and anxiety symptoms among crack cocaine-dependent individuals.,"Although contingency management (CM) is effective in promoting abstinence and treatment retention among crack cocaine users who meet the criteria for cocaine dependence, less is known about its off-target effects. In this secondary analysis, we evaluated the impact of CM on depressive and anxiety symptoms in a sample of cocaine-dependent individuals under treatment. Sixty-five crack cocaine users who met the criteria for cocaine dependence were randomly assigned to receive 12 weeks of standard treatment alone (STA; n = 32) or 12 weeks of standard treatment plus CM (STCM; n = 33). The outcome measures of the secondary analysis were depressive and anxiety symptoms assessed with the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI). At baseline, 59 (90.8%) of the participants reported at least mild depressive symptoms and 47 (72.5%) reported at least mild anxiety symptoms. The mean BDI-II (24.5 ± 12.1) and BAI (20.7 ± 13.5) scores in the sample as a whole was moderate. After treatment, the reported levels of depressive symptoms (β = -9.6, p < .05) and anxiety symptoms (β = -9.9, p < .05) were lower among the individuals receiving STCM than among those receiving STA. This study provides evidence that an STCM intervention targeting crack cocaine abstinence also produces significant reductions in depressive and anxiety symptoms. This low cost intervention also demonstrated significant promise and optimization potential for crack cocaine users in a setting of scarce resources and high mental health comorbidity. Relevance Statement: We found that the prevalence of depressive and anxiety symptoms were extremely high among crack cocaine users, and that, among such individuals, contingency management (CM) reduced depressive and anxiety symptomatology to a greater degree than did standard treatment. Our results suggest that CM targeting crack cocaine abuse can have off-target effects on psychiatric symptomatology. (PsycINFO Database Record",2017,"After treatment, the reported levels of depressive symptoms (β = -9.6, p < .05) and anxiety symptoms (β = -9.9, p < .05) were lower among the individuals receiving STCM than among those receiving STA.","['Sixty-five crack cocaine users who met the criteria for cocaine dependence', 'crack cocaine-dependent individuals']","['STCM intervention', 'STCM', 'contingency management (CM', 'standard treatment alone (STA; n = 32) or 12 weeks of standard treatment plus CM (STCM']","['mild depressive symptoms', 'depressive and anxiety symptoms assessed with the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI', 'mean BDI-II (24.5 ± 12.1) and BAI', 'depressive and anxiety symptomatology', 'depressive and anxiety symptoms', 'anxiety symptoms', 'prevalence of depressive and anxiety symptoms', 'levels of depressive symptoms', 'mild anxiety symptoms']","[{'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0085163', 'cui_str': 'Crack Cocaine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600427', 'cui_str': 'Cocaine Dependence'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0548465,"After treatment, the reported levels of depressive symptoms (β = -9.6, p < .05) and anxiety symptoms (β = -9.9, p < .05) were lower among the individuals receiving STCM than among those receiving STA.","[{'ForeName': 'André Q C', 'Initials': 'AQC', 'LastName': 'Miguel', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}, {'ForeName': 'Clarice S', 'Initials': 'CS', 'LastName': 'Madruga', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry and Medical Psychology.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Yamauchi', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Simões', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}, {'ForeName': 'Ariadne', 'Initials': 'A', 'LastName': 'Ribeiro', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}, {'ForeName': 'Claudio J', 'Initials': 'CJ', 'LastName': 'da Silva', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fruci', 'Affiliation': 'Program of Excellence in Addictions Research, Washington State University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McDonell', 'Affiliation': 'Program of Excellence in Addictions Research, Washington State University.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'Program of Excellence in Addictions Research, Washington State University.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Roll', 'Affiliation': 'Program of Excellence in Addictions Research, Washington State University.'}, {'ForeName': 'Ronaldo R', 'Initials': 'RR', 'LastName': 'Laranjeira', 'Affiliation': 'National Institute of Policies on Alcohol and Drugs (INPAD).'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000147']
824,29192549,"A Single-Dose, Two-Way Crossover, Open-Label Bioequivalence Study of an Amphetamine Extended-Release Oral Suspension in Healthy Adults.","Objective:  The purpose of this study was to compare the pharmacokinetics of a new extended-release amphetamine oral suspension (AMP XR-OS) with a standard extended-release mixed amphetamine salts product, Adderall XR®.  Method : In this single-dose, open-label, randomized, two-period, two-treatment crossover study, 42 healthy adult volunteers received 15 mL of AMP XR-OS in one period and a 30 mg Adderall XR capsule in another period (both containing 18.8 mg of amphetamine base) under fasted conditions. Blood samples were analyzed for  d - and  l -amphetamine concentrations, and pharmacokinetic parameters C max , AUC 0-5 , AUC 5-last , and AUC inf  were calculated to determine bioequivalence. Safety was monitored throughout the study.  Results : The 90% confidence intervals (CIs) for the log-transformed C max , AUC 0-5 , AUC 5-last , and AUC inf  fell within the accepted 80% to 125% range for establishing bioequivalence for  d - and  l -amphetamine. The most common adverse events were nausea and decreased appetite.  Conclusion : AMP XR-OS is bioequivalent to Adderall XR in healthy adult participants.",2020,"The 90% confidence intervals (CIs) for the log-transformed C max , AUC 0-5 , AUC 5-last , and AUC inf  fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine.","['healthy adult participants', 'Healthy Adults', '42 healthy adult volunteers received']","['Amphetamine Extended-Release Oral Suspension', '15 mL of AMP XR-OS', 'AMP XR-OS', 'amphetamine oral suspension (AMP XR-OS']","['Safety', 'nausea and decreased appetite', 'd- and l-amphetamine concentrations, and pharmacokinetic parameters C max , AUC 0-5 , AUC 5-last , and AUC inf']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0023567', 'cui_str': 'l-Amphetamine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",42.0,0.0213624,"The 90% confidence intervals (CIs) for the log-transformed C max , AUC 0-5 , AUC 5-last , and AUC inf  fell within the accepted 80% to 125% range for establishing bioequivalence for d- and l-amphetamine.","[{'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Sikes', 'Affiliation': 'Neos Therapeutics Inc., Grand Prairie, TX, USA.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Stark', 'Affiliation': 'Worldwide Clinical Trials, Austin, TX, USA.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'McMahen', 'Affiliation': 'Neos Therapeutics Inc., Grand Prairie, TX, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Engelking', 'Affiliation': 'Neos Therapeutics Inc., Grand Prairie, TX, USA.'}]",Journal of attention disorders,['10.1177/1087054717743329']
825,27259675,Assessment of the vaginal residence time of biomarkers of semen exposure.,"OBJECTIVE


The primary objective of this pilot study is to determine and compare the residence time in the vagina of biomarkers of semen exposure for up to 15 days post exposure. The biomarkers are prostate-specific antigen (PSA), Y chromosome DNA, the sex determining region of the Y chromosome (SRY) and testis-specific protein Y-encoded 4 (TSPY4). The secondary objectives are to determine if biomarker concentrations differed between intercourse and inoculation groups, to establish whether the sampling frequency post exposure affected biomarker concentrations and decay profile and to determine if biomarker concentrations in vaginal swabs obtained by the participant at home were similar to swabs obtained by the nurse in the clinic.
STUDY DESIGN


We randomized healthy women to unprotected intercourse (n=17) versus vaginal inoculation with the male partner's semen in the clinic (n=16). Women were then further randomized to have vaginal swabs obtained at either 7 or 4 time points after semen exposure, up to 15 days post exposure, either obtained at home by the participant or in the clinic by the research nurse.
RESULTS


PSA and SRY were markers of recent semen exposure. TSPY4 was detectable in approximately 50% of participants at 15 days post exposure. Unprotected intercourse resulted in significantly higher concentrations of select biomarkers. Sampling frequency and home versus clinic sampling had no significant effect on biomarker concentrations.
CONCLUSIONS


Objective biomarkers of recent or distant semen exposure may have great utility for verifying protocol compliance in a variety of clinical trials.",2016,"Sampling frequency and home versus clinic sampling had no significant effect on biomarker concentrations.
","[""healthy women to unprotected intercourse (n=17) versus vaginal inoculation with the male partner's semen in the clinic (n=16""]",[],"['biomarker concentrations', 'TSPY4']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1578545', 'cui_str': 'Unprotected intercourse'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],"[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0484342,"Sampling frequency and home versus clinic sampling had no significant effect on biomarker concentrations.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Thurman', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA. Electronic address: thurmaar@evms.edu.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Jacot', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Melendez', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kimble', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Snead', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Jamshidi', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Wheeless', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mauck', 'Affiliation': 'Eastern Virginia Medical School, 601 Colley Avenue, Room 235, Norfolk, VA 23507, USA.'}]",Contraception,['10.1016/j.contraception.2016.05.012']
826,32412417,A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial.,"BACKGROUND


Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial.
OBJECTIVE


The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program.
METHODS


Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks.
RESULTS


Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (β=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
CONCLUSIONS


The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy.
TRIAL REGISTRATION


Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12884-017-1228-5.",2020,"This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
","['Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation', 'Healthy Nutrition in Women Before and During Early Pregnancy', 'women using the Smarter Pregnancy program']","['control group did not receive coaching', 'personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements', 'Mobile App Lifestyle Intervention']","['reduction in DRS', 'vegetable intake', 'compliance and effectiveness', 'dietary risk score (DRS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C5200690', 'cui_str': 'Healthy Nutrition'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.112521,"This reduction was mainly due to increased vegetable intake (β=.55, 95% CI 0.25-0.86).
","[{'ForeName': 'Matthijs R', 'Initials': 'MR', 'LastName': 'van Dijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Maria P H', 'Initials': 'MPH', 'LastName': 'Koster', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Elsje C', 'Initials': 'EC', 'LastName': 'Oostingh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Eric A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Régine P M', 'Initials': 'RPM', 'LastName': 'Steegers-Theunissen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus Medical Center, University Medical Center Rotterdam, Rotterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/15773']
827,16123767,The effects of a subpsychotic dose of ketamine on recognition and source memory for agency: implications for pharmacological modelling of core symptoms of schizophrenia.,"Ketamine is increasingly used to model the cognitive deficits and symptoms of schizophrenia. We investigated the extent to which ketamine administration in healthy volunteers reproduces the deficits in episodic recognition memory and agency source monitoring reported in schizophrenia. Intravenous infusions of placebo or 100 ng/ml ketamine were administered to 12 healthy volunteers in a double-blind, placebo-controlled, randomized, within-subjects study. In response to presented words, the subject or experimenter performed a deep or shallow encoding task, providing a 2(drug) x 2(depth of processing) x 2(agency) factorial design. At test, subjects discriminated old/new words, and recalled the sources (task and agent). Data were analyzed using multinomial modelling to identify item recognition, source memory for agency and task, and guessing biases. Under ketamine, item recognition and cued recall of deeply encoded items were impaired, replicating previous findings. In contrast to schizophrenia, there was a reduced tendency to externalize agency source guessing biases under ketamine. While the recognition memory deficit observed with ketamine is consistent with previous work and with schizophrenia, the changes in source memory differ from those reported in schizophrenic patients. This difference may account for the pattern of psychopathology induced by ketamine.",2006,We investigated the extent to which ketamine administration in healthy volunteers reproduces the deficits in episodic recognition memory and agency source monitoring reported in schizophrenia.,"['agency', 'healthy volunteers reproduces the deficits in episodic recognition memory and agency source monitoring reported in schizophrenia', '12 healthy volunteers']","['Ketamine', 'ketamine', 'placebo or 100 ng/ml ketamine', 'placebo']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]",[],12.0,0.0500674,We investigated the extent to which ketamine administration in healthy volunteers reproduces the deficits in episodic recognition memory and agency source monitoring reported in schizophrenia.,"[{'ForeName': 'Garry D', 'Initials': 'GD', 'LastName': 'Honey', 'Affiliation': 'Department of Psychiatry, University of Cambridge, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': ""O'loughlin"", 'Affiliation': ''}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Turner', 'Affiliation': ''}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Pomarol-Clotet', 'Affiliation': ''}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Corlett', 'Affiliation': ''}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,[]
828,28623849,"Population Pharmacokinetics/Pharmacodynamics of 3,4-Diaminopyridine Free Base in Patients With Lambert-Eaton Myasthenia.","Lambert-Eaton myasthenia (LEM) is a rare autoimmune disorder associated with debilitating muscle weakness. There are limited treatment options and 3,4-diaminopyridine (3,4-DAP) free base is an investigational orphan drug used to treat LEM-related weakness. We performed a population pharmacokinetic/pharmacodynamic (PK/PD) analysis using 3,4-DAP and metabolite concentrations collected from a phase II study in patients with LEM. The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure. A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis. A two-compartment and one-compartment model for parent and metabolite, respectively, described the PK data well. Body weight and serum creatinine partially explained the variability in clearance for the final PK model. A fractional inhibitory maximum effect (E max  ) model characterized the exposure-response relationship well. The PK/PD model was applied to identify a suggested dosing approach for 3,4-DAP free base.",2017,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","['Patients With Lambert-Eaton Myasthenia', 'patients with LEM', 'A total of 1,270 PK samples (49 patients) and 1,091 3TUG data points (32 randomized patients) were included in the PK/PD analysis']","['Lambert-Eaton myasthenia (LEM', '3,4-Diaminopyridine', '3,4-diaminopyridine']",['Body weight and serum creatinine'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0947912'}, {'cui': 'C0115922', 'cui_str': 'leukocyte pyrogen'}, {'cui': 'C0046948', 'cui_str': '3,4-Pyridinediamine'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",32.0,0.049487,"The Triple Timed Up & Go (3TUG) assessment, which measures lower extremity weakness, was the primary outcome measure.","[{'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Thakkar', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Aleš', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jacobus', 'Affiliation': 'Jacobus Pharmaceutical Company, Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Peloquin', 'Affiliation': 'College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12218']
829,28421384,The efficacy of Guolin-Qigong on the body-mind health of Chinese women with breast cancer: a randomized controlled trial.,"PURPOSE


This study was to evaluate the efficacy of a complementary Chinese treatment modality Guolin-Qigong (GLQG) for patients with breast cancer on the body-mind health.
METHODS


A randomized controlled clinical trial was conducted among 158 women with breast cancer. Subjects were randomized to receive GLQG (test group) versus a physical stretching program (control group) following conventional treatment for breast cancer. GLQG and stretching interventions were performed twice a week over 24 weeks. The primary outcome was the change in quality of life (QoL). Secondary outcome measures included anxiety, depression, and clinical indicators. All participants were assessed at four time-points, at the beginning of the study (T1), after 12 weeks of the intervention (T2), immediately after 24-week intervention (T3), and at 48-week follow-up visit (T4).
RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P < 0.001). The test group showed an improvement in anxiety levels (P < 0.01), whereas the control group showed improvements in depression (P < 0.05) but there was no significant difference between groups (P > 0.05). Both groups showed improvements in immunological function and the test group fared better than the control in TNF-α levels (P < 0.05). The results in subjects who practiced more than 4 times and 6 h per week were similar to that of all subjects; however, the improvement in anxiety in the GLQG group was more obvious. There are positive correlations between QoL and anxiety and depression.
CONCLUSIONS


Both GLQG and physical stretching are beneficial during recovery following breast cancer. GLQC was more effective in terms of Qol improvements than physical stretching. Both programs brought improvements in anxiety or depression but had were comparable. GLQC group had a greater effect on immunological function than physical exercise.",2017,"RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P ","['patients with breast cancer on the body-mind health', 'Chinese women with breast cancer', '158 women with breast cancer']","['GLQG and stretching interventions', 'complementary Chinese treatment modality Guolin-Qigong (GLQG', 'GLQG and physical stretching', 'Guolin-Qigong', 'GLQC', 'GLQG', 'physical stretching program (control group) following conventional treatment']","['anxiety, depression, and clinical indicators', 'QoL and anxiety and depression', 'depression', 'anxiety or depression', 'anxiety levels', 'change in quality of life (QoL', 'QoL', 'TNF-α levels', 'immunological function', 'anxiety', 'breast cancer-specific well-being (P']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",158.0,0.0495292,"RESULTS


Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week (P < 0.01) and particularly in emotional well-being (P < 0.01) and breast cancer-specific well-being (P ","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jieshu', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Wing T Y', 'Initials': 'WTY', 'LastName': 'Loo', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Youzhi', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Sit', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Meikuen', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': ""School of Public Health, Peking University, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Neng', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. abchen@hku.hk.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-017-1576-7']
830,28388850,Auditory and Visual Executive Functions in Children and Response to Methylphenidate: A Randomized Controlled Trial.,Objectives:  The aim of the study was to assess auditory and visually based executive functions (EFs) and the effect of methylphenidate (MPH) in children with ADHD.  Methods:  Thirty-six boys between the ages of 8.3 and 9.7 years with ADHD and 36 matched controls were included. The study group was randomized into MPH and placebo for 7 days each in a crossover design. A Cued Choice Reaction Time (CCRT) test that included incongruent cuing was administered at baseline and following 1 and 2 weeks.  Results:  The difference between the study and control groups was more evident with visual cues and incongruent cuing. Increased gains by children with predominantly hyperactive-impulsive\combined (HI\C) type of ADHD were observed under MPH.  Conclusions:  The differences between children with ADHD and typical children are more pronounce under incongruent auditory cuing . The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.,2020,The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.,"['Thirty-six boys between the ages of 8.3 and 9.7 years with ADHD and 36 matched controls were included', 'children with ADHD and typical children', 'children with ADHD']","['methylphenidate (MPH', 'Methylphenidate', 'MPH and placebo']","['visual cues and incongruent cuing', 'Auditory and Visual Executive Functions', 'pronounce under incongruent auditory cuing ']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",36.0,0.113036,The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.,"[{'ForeName': 'Yaffa', 'Initials': 'Y', 'LastName': 'Hadar', 'Affiliation': 'Haifa University, Israel.'}, {'ForeName': 'Shraga', 'Initials': 'S', 'LastName': 'Hocherman', 'Affiliation': 'Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Lamm', 'Affiliation': 'Haifa University, Israel.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Tirosh', 'Affiliation': 'Technion-Israel Institute of Technology, Haifa, Israel.'}]",Journal of attention disorders,['10.1177/1087054717700978']
831,28484915,Impact of marital status and comorbid disorders on health-related quality of life after cardiac surgery.,"PURPOSE


To explore associations between HRQL, marital status, and comorbid disorders in men and women following cardiac surgery.
METHOD


A secondary analysis was completed using data from a randomized controlled trial in which 416 individuals (23% women) scheduled for elective coronary artery bypass graft and/or valve surgery were recruited between March 2012 and September 2013. HRQL was assessed using the Health State Descriptive System (15D) preoperatively, then at 2 weeks, and at 3, 6, and 12 months following cardiac surgery. Linear mixed model analyses were performed to explore associations between HRQL, social support, and comorbid disorders.
RESULTS


The overall 15D scores for the total sample improved significantly from 2 weeks to 3 months post surgery, with only a gradual change observed from 3 to 12 months. Thirty percent (n = 92) of the total sample reported a lower 15D total score at 12 months compared to preoperative status, of whom 78% (n = 71) had a negative minimum important differences (MID), indicating a worse HRQL status. When adjusted for age and marital status, women had statistically significant lower 15D total scores compared to men at 3, 6, and 12 months post surgery. Compared to pre-surgery, improvement was demonstrated in 4 out of 15 dimensions of HRQL for women, and in 6 out of 15 dimensions for men at 12 months post surgery. Both men and women associated back/neck problems, depression, and persistent pain intensity with lower HRQL; for women, not living with a partner/spouse was associated with lower HRQL up to 12 months.
CONCLUSION


Women experienced decreased HRQL and a slower first-year recovery following cardiac surgery compared to men. This study demonstrates a need for follow-up and support to help women manage their symptoms and improve their function within the first year after cardiac surgery. This was particularly pronounced for those women living alone.",2017,"Compared to pre-surgery, improvement was demonstrated in 4 out of 15 dimensions of HRQL for women, and in 6 out of 15 dimensions for men at 12 months post surgery.","['416 individuals (23% women) scheduled for elective coronary artery bypass graft and/or valve surgery were recruited between March 2012 and September 2013', 'men and women following cardiac surgery']",[],"['overall 15D scores', '15D total scores', 'lower 15D total score', 'HRQL', 'back/neck problems, depression, and persistent pain intensity with lower HRQL']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0601303,"Compared to pre-surgery, improvement was demonstrated in 4 out of 15 dimensions of HRQL for women, and in 6 out of 15 dimensions for men at 12 months post surgery.","[{'ForeName': 'Ann Kristin', 'Initials': 'AK', 'LastName': 'Bjørnnes', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada. ann-kristin.bjornnes@hioa.no.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Parry', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Falk', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Watt-Watson', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, 155 College Street, Suite 130, Toronto, ON, M5T 1P8, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lie', 'Affiliation': 'Division of Cardiovascular and Pulmonary Diseases, Department of Cardiothoracic Surgery, Ullevål/Center for Patient Centered Heart- and Lung Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Leegaard', 'Affiliation': 'Faculty of Health Sciences, Institute of Nursing, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-017-1589-2']
832,27756854,"The Time Course of Effect of Multilayer-Release Methylphenidate Hydrochloride Capsules: A Randomized, Double-Blind Study of Adults With ADHD in a Simulated Adult Workplace Environment.","Objective:  The aim of this study is to assess the onset and duration of efficacy of multilayer-release methylphenidate (PRC-063) over 16 hr compared with placebo in adults with ADHD using the simulated adult workplace environment.  Method:  After dose-optimization with PRC-063, participants entered a double-blind, placebo-controlled, crossover phase. Primary outcome measure was the Permanent Product Measure of Performance (PERMP) total score measured pre-dose and from 1 to 16 hr post-dose.  Results:  Of the 59 randomized participants, 45 participants completed the study. While receiving PRC-063, adults had greater mean PERMP total scores across all time points compared with placebo (268.7 ± 11.24 vs. 255.6 ± 10.87;  p  = .0064). Common adverse events were decreased appetite, headache, and insomnia. There was no significant impact on overall sleep quality ( p  = .9542).  Conclusion:  PRC-063 significantly improved PERMP scores with an onset within 1 hr post-dose, and maintained improvement throughout the 16 hr post-dose study period compared with placebo in adults with ADHD.",2020,"There was no significant impact on overall sleep quality ( p = .9542).
","['Adults With ADHD in a Simulated Adult Workplace Environment', 'adults with ADHD', 'adults with ADHD using the simulated adult workplace environment', '45 participants completed the study', '59 randomized participants']","['PRC-063', 'multilayer-release methylphenidate (PRC-063', 'placebo', 'Multilayer-Release Methylphenidate Hydrochloride Capsules']","['appetite, headache, and insomnia', 'PERMP scores', 'Permanent Product Measure of Performance (PERMP) total score measured pre-dose and from 1 to 16 hr post-dose', 'mean PERMP total scores', 'overall sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700545', 'cui_str': 'Methylphenidate Hydrochloride'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose (qualifier value)'}, {'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",59.0,0.388643,"There was no significant impact on overall sleep quality ( p = .9542).
","[{'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Wigal', 'Affiliation': 'AVIDA, Newport Beach, CA, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wigal', 'Affiliation': 'AVIDA, Newport Beach, CA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine Inc., Las Vegas, NV, USA.'}, {'ForeName': 'Graeme A E', 'Initials': 'GAE', 'LastName': 'Donnelly', 'Affiliation': 'Purdue Pharma Canada, Pickering, Ontario, Canada.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Reiz', 'Affiliation': 'Purdue Pharma Canada, Pickering, Ontario, Canada.'}]",Journal of attention disorders,['10.1177/1087054716672335']
833,32124422,Study of the effects of adapted Tango and multidimensional intervention in pREvention of dementia in agiNG: developing healTHy lifestyle programs (STRENGTH Project)-the experimental protocol of a prospective randomised controlled trial.,"BACKGROUND


Dementia represents a key health issue for older adults, with negative consequences on psycho-social and functional status. Treatments that counteract cognitive deficits in mild cognitive impairment (MCI) are needed to prevent or delay it.
AIM


To describe the experimental protocol of the STRENGTH Project. This study investigates a multimodal intervention in older adults with MCI to improve cognitive, functional, biochemical and psycho-social aspects.
METHODS


The prospective randomised controlled trial will enrol 300 subjects with MCI (age ≥ 60 years). Participants will be randomly assigned to: (a) the experimental group, which will undergo sessions of adapted tango, music therapy, engagement in social activities, cognitive intervention and psycho-education for 6 months or (b) the control group, which will receive psycho-education and advice on healthy lifestyle for 6 months. All outcomes will be analysed before intervention (baseline), immediately after termination (follow-up 1), after 6 months (follow-up 2) and after 2 years (follow-up 3).
DISCUSSION


We expect that the findings of this multidisciplinary study will be useful to optimize clinical and psycho-social interventions for improving cognitive and functional status of subjects with MCI.
CONCLUSIONS


This project could have a meaningful impact on National Health Systems by providing clues on multidisciplinary management of older adults affected by cognitive decline to prevent dementia.",2020,This project could have a meaningful impact on National Health Systems by providing clues on multidisciplinary management of older adults affected by cognitive decline to prevent dementia.,"['300 subjects with MCI (age\u2009≥', 'mild cognitive impairment (MCI', 'older adults', 'older adults with MCI']","['adapted Tango and multidimensional intervention', 'multimodal intervention', 'adapted tango, music therapy, engagement in social activities, cognitive intervention and psycho-education for 6\xa0months or (b) the control group, which will receive psycho-education and advice on healthy lifestyle for 6\xa0months']",[],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]",[],300.0,0.0584361,This project could have a meaningful impact on National Health Systems by providing clues on multidisciplinary management of older adults affected by cognitive decline to prevent dementia.,"[{'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Giuli', 'Affiliation': 'Geriatrics Operative Unit, Italian National Research Centre on Aging (IRCCS INRCA), Contrada Mossa, 2, 63900, Fermo, Italy. c.giuli@inrca.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Paoloni', 'Affiliation': 'Geriatrics Operative Unit, Italian National Research Centre on Aging (IRCCS INRCA), Contrada Mossa, 2, 63900, Fermo, Italy.'}, {'ForeName': 'Elpidio', 'Initials': 'E', 'LastName': 'Santillo', 'Affiliation': 'Geriatric-Rehabilitative Department, Italian National Research Centre on Aging (IRCCS INRCA), Contrada Mossa, Fermo, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Balietti', 'Affiliation': 'Center for Neurobiology of Aging, (IRCCS INRCA), Via Birarelli, Ancona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fabbietti', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology and Biostatistics, Italian National Research Centre on Aging (IRCCS INRCA), Via S. Margherita, Ancona, Italy.'}, {'ForeName': 'Demetrio', 'Initials': 'D', 'LastName': 'Postacchini', 'Affiliation': 'Geriatrics Operative Unit, Italian National Research Centre on Aging (IRCCS INRCA), Contrada Mossa, 2, 63900, Fermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Piacenza', 'Affiliation': 'Advanced Technology Center for Aging Research, Scientific Technological Area, Italian National Research Centre on Aging (IRCCS INRCA), Via Birarelli, Ancona, Italy.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01504-4']
834,31898309,Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial.,"BACKGROUND


Men with advanced prostate cancer (APC) face multiple challenges including poor prognosis, poor health-related quality of life (HRQOL), and elevated symptom burden. This study sought to establish the efficacy of a tablet-delivered, group-based psychosocial intervention for improving HRQOL and reducing symptom burden in men with APC. We hypothesized that men randomized to cognitive-behavioral stress management (CBSM) would report improved HRQOL and reduced symptom burden relative to men randomized to an active control health promotion (HP) condition. Condition effects on intervention targets and moderators of these effects were explored.
METHODS


Men with APC (N = 192) were randomized (1:1) to 10-week tablet-delivered CBSM or HP, and followed for 1 year. Multilevel modeling was used to evaluate condition effects over time.
RESULTS


Changes in HRQOL and symptom burden did not differ between groups. Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time. Moderating factors included baseline interpersonal disruption, fatigue, and sexual functioning.
CONCLUSIONS


Tablet-delivered CBSM and HP were well received by men with APC. The hypothesized effects of CBSM on HRQOL and symptom burden were not supported, though improvements in intervention targets were observed across conditions. Participants reported high-baseline HRQOL relative to cancer and general population norms, possibly limiting intervention effects. The identified moderating factors should be considered in the development and implementation of interventions targeting HRQOL and symptom burden.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03149185.",2020,"Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time.","['men with APC', 'Men with APC (N\u2009=\u2009192', 'Men with advanced prostate cancer (APC', 'Men with Advanced Prostate Cancer']","['CBSM', 'cognitive-behavioral stress management (CBSM', 'CBSM or HP', 'tablet-delivered, group-based psychosocial intervention', 'Technology-Based Psychosocial Intervention']","['HRQOL and symptom burden', 'baseline interpersonal disruption, fatigue, and sexual functioning', 'Quality of Life', 'cancer-related anxiety, cancer-related distress, and feelings of cohesiveness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.300426,"Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time.","[{'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA. frank.penedo@miami.edu.'}, {'ForeName': 'Rina S', 'Initials': 'RS', 'LastName': 'Fox', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Oswald', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Moreno', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Cody L', 'Initials': 'CL', 'LastName': 'Boland', 'Affiliation': 'Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA.'}, {'ForeName': 'Ryne', 'Initials': 'R', 'LastName': 'Estabrook', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'McGinty', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Begale', 'Affiliation': 'Vibrent Health, Fairfax, VA, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Dahn', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Miami Veterans Affairs Healthcare System, Miami, FL, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Flury', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Kent T', 'Initials': 'KT', 'LastName': 'Perry', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Shilajit D', 'Initials': 'SD', 'LastName': 'Kundu', 'Affiliation': 'Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Betina', 'Initials': 'B', 'LastName': 'Yanez', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-019-09839-7']
835,31503028,"The Effect of Stabilization Exercises Along With Self-care Training on Transverse Abdominal Activity, Pain, and Disability in Mothers With Low Back Pain Having Children With Cerebral Palsy: A Randomized Controlled Trial.","OBJECTIVE


Many mothers of children with cerebral palsy experience low back pain, so the purpose of this study was to investigate the effect of stabilization exercises along with self-care training on transverse abdominal muscle activity, pain, disability, and depression in them.
DESIGN


In this single-blinded randomized clinical trial, 32 mothers with cerebral palsy children were selected were randomly divided into two groups. Both groups received self-care training individually. For the experimental group, in addition to the self-care training, 24 sessions of stabilization exercises were held. Outcome measures included visual analog scale, Roland-Morris Disability Questionnaire, Persian version of Beck Depression Inventory-II, and ultrasonography.
RESULTS


In the experimental group, the transverse abdominal muscle activity during abdominal hollowing exercises was significantly increased (P < 0.05). There was no significant difference between the two groups in pain, disability, and depression (P > 0.05).
CONCLUSIONS


Stabilization exercises could improve the voluntary activity of transverse abdominal muscle of mothers of children with cerebral palsy.",2020,In the experimental group the transverse abdominal muscle activity during abdominal hollowing exercises were significantly increased (p <0.05).,"['mothers with low back pain having children with CP', 'mothers of children with cerebral palsy', '32 mothers with CP children', 'mothers of children with cerebral palsy (CP) experience low back pain (LBP']","['stabilization exercises along with self-care training', 'Stabilization exercises']","['transverse abdominal muscle activity', 'transverse abdominal muscle activity, pain, disability and depression', 'transverse abdominal activity, pain, and disability', 'voluntary activity of transverse abdominal muscle', 'pain, disability and depression', 'Visual Analog Scale, Roland-Morris Disability Questionnaire, Persian version of Beck Depression Inventory-II and ultrasonography']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0224378', 'cui_str': 'Transverse Abdominal'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]",32.0,0.033386,In the experimental group the transverse abdominal muscle activity during abdominal hollowing exercises were significantly increased (p <0.05).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadizadeh', 'Affiliation': 'From the Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran (ZA, FE); Department of Occupational Therapy, School of Rehabilitation Science, Iran University of Medical Sciences, Tehran, Iran (ZA); Neuromuscular Rehabilitation Research Center, Department of Neurology, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran (SAS); and Social Determinant of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran (MM).'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': ''}, {'ForeName': 'Syed Afshin', 'Initials': 'SA', 'LastName': 'Samaei', 'Affiliation': ''}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirmohammadkhani', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001315']
836,32492138,No effect of resveratrol supplementation after 6 months on insulin sensitivity in overweight adults: a randomized trial.,"BACKGROUND


Effects of resveratrol on metabolic health have been studied in several short-term human clinical trials, with conflicting results. Next to dose, the duration of the clinical trials may explain the lack of effect in some studies, but long-term studies are still limited.
OBJECTIVES


The objective of this study was to investigate the effects of 6-mo resveratrol supplementation on metabolic health outcome parameters.
METHODS


Forty-one overweight men and women (BMI: 27-35 kg/m2; aged 40-70 y) completed the study. In this parallel-group, double-blind clinical trial, participants were randomized to receive either 150 mg/d of resveratrol (n = 20) or placebo (n = 21) for 6 mo. The primary outcome of the study was insulin sensitivity, using the Matsuda index. Secondary outcome measures were intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep. Postintervention differences between the resveratrol and placebo arms were evaluated by ANCOVA adjusting for corresponding preintervention variables.
RESULTS


Preintervention, no differences were observed between the 2 treatment arms. Insulin sensitivity was not affected after 6 mo of resveratrol treatment (adjusted mean Matsuda index: 5.18 ± 0.35 in the resveratrol arm compared with 5.50 ± 0.34 in the placebo arm), although there was a significant difference in postintervention glycated hemoglobin (HbA1c) between the arms (P = 0.007). The adjusted means showed that postintervention HbA1c was lower on resveratrol (35.8 ± 0.43 mmol/mol) compared with placebo (37.6 ± 0.44 mmol/mol). No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
CONCLUSIONS


After 6 mo of resveratrol supplementation, insulin sensitivity was unaffected in the resveratrol arm compared with the placebo arm. Nonetheless, HbA1c was lower in overweight men and women in the resveratrol arm. This trial was registered at Clinicaltrials.gov as NCT02565979.",2020,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","['overweight adults', 'Forty-one overweight men and women', 'BMI: 27-35 kg/m2; aged 40-70 y) completed the study']","['6-mo resveratrol supplementation', 'placebo', 'resveratrol supplementation']","['insulin sensitivity, using the Matsuda index', 'metabolic health outcome parameters', 'postintervention glycated hemoglobin (HbA1c', 'postintervention HbA1c', 'insulin sensitivity', 'IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep', 'Insulin sensitivity', 'intrahepatic lipid (IHL) content, body composition, resting energy metabolism, blood pressure, plasma markers, physical performance, quality of life, and quality of sleep']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",41.0,0.562601,"No postintervention differences were found in IHL, body composition, blood pressure, energy metabolism, physical performance, or quality of life and sleep between treatment arms.
","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'de Ligt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Bergman', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Rodrigo Mancilla', 'Initials': 'RM', 'LastName': 'Fuentes', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Essers', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Department of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, Netherlands.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa125']
837,31577520,Efficacy of L-leucine Supplementation Coupled With Resistance Training in Untrained Midlife Women.,"Objective:  This study investigated the effects of leucine supplementation with resistance training (RT) in untrained peri- and postmenopausal women on fat free mass, strength, and select anabolic-related hormones. Method:  This was a randomized, double-blind, placebo-controlled trial, in which 36 untrained women were randomly assigned to either a leucine or placebo supplement group coupled with 10 weeks of RT, performed thrice weekly, while ingesting either 5 g of placebo or leucine. Before and after RT, body composition and muscle strength were assessed and venous blood samples obtained to determine the levels of estradiol, testosterone, insulin-like growth factor-1, growth hormone, and cortisol. Data were analyzed by utilizing separate 2 × 2 [group × time (pretest and posttest)] factorial analyses of variance with repeated measures ( p  ≤ .05). Results:  There were no significant changes or differences between groups in fat free mass or with any of the serum hormones assessed in response to supplementation. However, there were significant increases in strength in both groups in response to RT, but not supplementation. Conclusions:  Peri- and postmenopausal women had significant increases in strength following 10 weeks of RT, with no additional effects from supplementing with leucine. There were no significant changes in either group regarding fat free mass or serum hormones.",2020,There were no significant changes or differences between groups in fat free mass or with any of the serum hormones assessed in response to supplementation.,"['untrained peri- and postmenopausal women', 'Peri- and postmenopausal women', '36 untrained women', 'Untrained Midlife Women']","['leucine or placebo supplement', 'placebo', 'placebo or leucine', 'L-leucine Supplementation Coupled With Resistance Training', 'leucine supplementation with resistance training (RT']","['levels of estradiol, testosterone, insulin-like growth factor-1, growth hormone, and cortisol', 'fat free mass or serum hormones', 'strength', 'body composition and muscle strength']","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.212499,There were no significant changes or differences between groups in fat free mass or with any of the serum hormones assessed in response to supplementation.,"[{'ForeName': 'LesLee K', 'Initials': 'LK', 'LastName': 'Funderburk', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Kaitlan N', 'Initials': 'KN', 'LastName': 'Beretich', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Chen', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1650675']
838,31575448,Dilute Betadine Lavage Reduces the Risk of Acute Postoperative Periprosthetic Joint Infection in Aseptic Revision Total Knee and Hip Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


The purpose of this randomized, controlled trial is to determine whether dilute betadine lavage compared to normal saline lavage reduces the rate of acute postoperative periprosthetic joint infection (PJI) in aseptic revision total knee (TKA) and hip arthroplasty (THA).
METHODS


A total of 478 patients undergoing aseptic revision TKA and THA were randomized to receive a 3-minute dilute betadine lavage (0.35%) or normal saline lavage before surgical wound closure. Fifteen patients were excluded following randomization (3.1%) and six were lost to follow-up (1.3%), leaving 457 patients available for study. Of them, 234 patients (153 knees, 81 hips) received normal saline lavage and 223 (144 knees, 79 hips) received dilute betadine lavage. The primary outcome was PJI within 90 days of surgery with a secondary assessment of 90-day wound complications. A priori power analysis determined that 285 patients per group were needed to detect a reduction in the rate of PJI from 5% to 1% with 80% power and alpha of 0.05.
RESULTS


There were eight infections in the saline group and 1 in the betadine group (3.4% vs 0.4%, P = .038). There was no difference in wound complications between groups (1.3% vs 0%, P = .248). There were no differences in any baseline demographics or type of revision procedure between groups, suggesting appropriate randomization.
CONCLUSION


Dilute betadine lavage before surgical wound closure in aseptic revision TKA and THA appears to be a simple, safe, and effective measure to reduce the risk of acute postoperative PJI.
LEVEL OF EVIDENCE


Level I.",2020,"There was no difference in wound complications between groups (1.3% vs 0%, P = .248).","['234 patients (153 knees, 81 hips) received', '478 patients undergoing aseptic revision TKA and THA', 'Aseptic Revision Total Knee and Hip Arthroplasty', 'aseptic revision TKA', 'aseptic revision total knee (TKA) and hip arthroplasty (THA', 'Fifteen patients were excluded following randomization (3.1%) and six were lost to follow-up (1.3%), leaving 457 patients available for study', 'and 223 (144 knees, 79 hips) received']","['3-minute dilute betadine lavage', 'betadine', 'dilute betadine lavage', 'normal saline lavage', 'Dilute Betadine Lavage']","['PJI within 90 days of surgery with a secondary assessment of 90-day wound complications', 'rate of acute postoperative periprosthetic joint infection (PJI', 'rate of PJI', 'wound complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C1096106'}]",478.0,0.343248,"There was no difference in wound complications between groups (1.3% vs 0%, P = .248).","[{'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Calkins', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL; Department of Orthopaedic Surgery and Biomedical Engineering, University of Tennessee-Campbell Clinic, Memphis, TN.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Culvern', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Nam', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Tad L', 'Initials': 'TL', 'LastName': 'Gerlinger', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Levine', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Sporer', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Della Valle', 'Affiliation': 'Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.09.011']
839,30877216,Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale.,"OBJECTIVE


We evaluated the effect of sarilumab on patient-perceived impact of rheumatoid arthritis (RA) using the 7-domain RA Impact of Disease (RAID) scale.
METHODS


Two phase III, randomized, controlled trials of sarilumab in patients with active, longstanding RA were analyzed: (1) sarilumab 150 mg and 200 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARD) versus placebo + csDMARD [TARGET (NCT01709578)]; and (2) sarilumab 200 mg versus adalimumab (ADA) 40 mg monotherapy [MONARCH (NCT02332590)]. Least-squares mean (LSM) differences in RAID total score (range 0-10) and 7 key RA symptoms, including pain and fatigue (baseline to Weeks 12 and 24), were compared. ""Responders"" by RAID total score were defined by improvements from baseline ≥ minimal clinically important difference (MCID), and ≥ patient-acceptable symptom-state (PASS) at endpoint.
RESULTS


Sarilumab 150 mg and 200 mg + csDMARD were nominally superior (p < 0.05) versus placebo + csDMARD and 200 mg sarilumab versus ADA 40 mg in LSM differences for RAID total score at weeks 12 (-0.93 and -1.13; -0.49, respectively) and 24 (-0.75 and -1.01; -0.78), and all effects of RA (except functional impairment in MONARCH Week 12). Effects were greater in physical domains (e.g., pain) than mental domains (e.g., emotional well-being). More patients receiving sarilumab versus placebo or ADA reported improvements ≥ MCID and PASS in total RAID scores at both assessments.
CONCLUSION


Based on the RAID, sarilumab + csDMARD or as monotherapy reduced the effect of RA on patients' lives to a greater extent than placebo + csDMARD or ADA monotherapy. (ClinicalTrials.gov: NCT01709578 and NCT02332590).",2019,"More patients receiving sarilumab versus placebo or adalimumab reported improvements ≥MCID and PASS in total RAID scores at both assessments.
","['patients with active, long-standing RA']","['sarilumab 150 mg and 200 mg twice-weekly plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARDs) versus placebo+csDMARDs [TARGET (NCT01709578)]; sarilumab 200 mg versus adalimumab 40 mg monotherapy', 'Sarilumab', 'adalimumab', 'placebo+csDMARDs', 'placebo or adalimumab']","['physical domains (e.g., pain', '≥Patient Acceptable Symptom State (PASS', '≥MCID and PASS in total RAID scores', 'Least squares mean (LSM) differences in RAID total score (range 0-10), and 7 key RA symptoms, including pain and fatigue', '7-domain RA Impact of Disease (RAID) scale', 'RAID total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0222045'}]",,0.132715,"More patients receiving sarilumab versus placebo or adalimumab reported improvements ≥MCID and PASS in total RAID scores at both assessments.
","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Proudfoot', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Chieh-I', 'Initials': 'CI', 'LastName': 'Chen', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guillonneau', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mangan', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Reaney', 'Affiliation': ""From the Sorbonne Université, Institut Pierre Louis d'Epidémiologie et de Santé Publique (UMRS 1136), GRC-UPMC 08 (EEMOIS); Rheumatology Department, Hôpital Pitié Salpêtrière, AP-HP, Paris, France; Stanford University, Palo Alto, California, USA; Sanofi, Guildford, UK; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA; Sanofi, Paris, France; Sanofi, Bridgewater, New Jersey, USA. matthew.reaney@iqvia.com.""}]",The Journal of rheumatology,['10.3899/jrheum.180904']
840,30104729,Translating advice to eat more vegetables into practice: observations from a 12-month weight loss trial.,"OBJECTIVES


This study aimed to identify the main vegetable sources of overweight participants during a 12-month randomised controlled trial for weight loss.
METHODS


Secondary analysis using data from diet history interviews to determine changes to daily vegetable intake amounts and types throughout the trial at 0, 3 and 12 months.
RESULTS


Pre-trial 77% participants consumed frozen vegetables. At baseline (n = 113, 85 F), participants reported 345 ± 170 (56-920) g/day vegetables increasing to 498 ± 180 (146-930) g/day at 3 months and remaining stable at 475 ± 169(170-1053) g/day by 12 months (p = 0.001). At baseline, 32 of 34 different vegetable categories were reported, mainly tomato (69.9 g/day) and, potato (58.2 g/day). After 3 months (n = 109), seven vegetables remained in the top 10 reported (contributing 72%). Tomato remained top ranked to 12 months.
CONCLUSION


Following advice to consume more vegetables, consumption increased above the Australian Dietary recommendation of ~375 g/day. Tomatoes remained a mainstay regardless of the time of year, but choices changed with time. Frozen vegetables may be a feasible option.",2019,"At baseline (n = 113, 85 F), participants reported 345 ± 170 (56-920) g/day vegetables increasing to 498 ± 180 (146-930) g/day at 3 months and remaining stable at 475 ± 169(170-1053) g/day by 12 months (p = 0.001).",['overweight participants'],[],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]",[],[],,0.244299,"At baseline (n = 113, 85 F), participants reported 345 ± 170 (56-920) g/day vegetables increasing to 498 ± 180 (146-930) g/day at 3 months and remaining stable at 475 ± 169(170-1053) g/day by 12 months (p = 0.001).","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': ""O'Shea"", 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tapsell', 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Thorne', 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Probst', 'Affiliation': 'School of Medicine, Faculty of Science Medicine and Health, University of Wollongong, Wollongong, NSW, Australia. yasmine@uow.edu.au.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0277-9']
841,30824635,Safety and Efficacy of Intravenous Golimumab in Adults with Ankylosing Spondylitis: Results through 1 Year of the GO-ALIVE Study.,"OBJECTIVE


Evaluate safety and efficacy of intravenous (IV) golimumab (GOL) in patients with active ankylosing spondylitis (AS) through 1 year.
METHODS


A total of 208 patients were randomized to IV infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, and every 8 weeks thereafter or placebo (n = 103) at weeks 0, 4, and 12, then crossover to GOL at weeks 16, 20, and every 8 weeks thereafter through Week 52. Efficacy was assessed using the Assessment of Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI). Health-related quality of life was assessed using the AS Quality of Life (ASQoL) index. Efficacy and safety were monitored through Week 52 and Week 60, respectively.
RESULTS


The primary endpoint (ASAS20) and all controlled endpoints at Week 16 were achieved. At Week 52, 69.5% and 65.0% of patients in the GOL group and placebo crossover group, respectively, achieved an ASAS20; 56.2% and 51.5% achieved an ASAS40; 56.2% and 55.3% achieved a BASDAI50; 24.8% and 24.3% achieved ASAS partial remission; and 25.7% and 26.2% met ASDAS inactive disease criteria (all last observation carried forward). Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6; ASQoL: -5.5 and -5.4). Through Week 60, 55.4% of all GOL-treated patients had ≥ 1 adverse events (AE); 3.4% had ≥ 1 serious AE.
CONCLUSION


Efficacy was maintained through 1 year with IV GOL 2 mg/kg among patients with active AS. AE were consistent with the known safety profile of GOL.",2019,Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6;,"['patients with active ankylosing spondylitis (AS) through 1 year', '208 patients', 'Adults with Ankylosing Spondylitis']","['intravenous (IV) golimumab (GOL', 'Intravenous Golimumab', 'placebo', 'GOL']","['Efficacy', 'BASFI and ASQoL scores', 'AS Quality of Life (ASQoL) index', 'Safety and Efficacy', 'Health-related quality of life', 'Efficacy and safety', 'Spondyloarthritis international Society (ASAS) criteria, the Ankylosing Spondylitis Disease Activity Score (ASDAS), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Index (BASFI', 'ASAS partial remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0150141'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",208.0,0.213888,Mean changes from baseline to Week 52 in BASFI and ASQoL scores were similar between the GOL group and the placebo crossover group (BASFI: -2.7 and -2.6;,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Reveille', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Caldron', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dudek', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'From the University of Texas McGovern Medical School, Houston, Texas; Oregon Health & Science University, Portland, Oregon; Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona; Janssen Research & Development LLC, Spring House, Pennsylvania; University of Pennsylvania, Philadelphia, Pennsylvania, USA; AMED Medical Center, Warsaw, Poland. ehsia@its.jnj.com.'}]",The Journal of rheumatology,['10.3899/jrheum.180718']
842,32415846,Adjunctive sertraline for asymptomatic cryptococcal antigenemia: A randomized clinical trial.,"Cryptococcal antigen (CrAg) screening in HIV-infected persons with CD4 < 100 cells/µl can reduce meningitis and death, yet preemptive fluconazole therapy fails in ∼25%. Sertraline has in vitro and in vivo activity against Cryptococcus and is synergistic with fluconazole in mice. We evaluated the efficacy and safety of sertraline in asymptomatic cryptococcal antigenemia. We conducted a randomized trial of asymptomatic CrAg-positive Ugandans from November 2017 to February 2018. All subjects received WHO standard therapy of fluconazole 800 mg for 2 weeks, then 400 mg for 10 weeks, then 200 mg through 24 weeks. Participants were randomized to receive adjunctive sertraline or placebo, given in once-weekly escalating 100 mg/day doses up to 400 mg/day, which was then given for 8 weeks, then tapered. The primary endpoint was meningitis-free 6-month survival. The data and safety monitoring board halted the trial after 21 subjects were enrolled due to safety concerns. Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants. However, seven serious adverse events (SAEs) occurred (n = 4 sertraline group; n = 3 placebo group). Three SAEs in the sertraline group presented with psychosis and aggressive behavioral changes with one meeting Hunter's criteria for serotonin syndrome while receiving 200 mg/day sertraline. Two transient psychoses were associated with antecedent fluconazole and sertraline interruption. The serotonin syndrome resolved within 1 day, but psychosis persisted for 4 months after sertraline discontinuation. Sertraline was associated with excess SAEs of psychosis. Due to early stopping, we were unable to determine any efficacy for cryptococcal antigenemia.",2020,Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants.,"['HIV-infected persons with CD4', 'asymptomatic cryptococcal antigenemia', 'asymptomatic CrAg-positive Ugandans from November 2017 to February 2018', '21 subjects were enrolled due to safety concerns']","['fluconazole', 'sertraline', 'adjunctive sertraline or placebo', 'Sertraline', 'Adjunctive sertraline', 'placebo']","['meningitis-free 6-month survival', 'efficacy and safety', 'meningitis and death', 'Meningitis-free 6-month survival']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0010415', 'cui_str': 'Cryptococcus'}, {'cui': 'C0522281', 'cui_str': 'Cryptococcal antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",21.0,0.245246,Meningitis-free 6-month survival occurred in 9 of 11 of placebo participants and 10 of 10 of sertraline participants.,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nalintya', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kirumira', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Naluyima', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Turya', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Namanda', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Morris K', 'Initials': 'MK', 'LastName': 'Rutakingirwa', 'Affiliation': 'Infectious Diseases Institute, Makerere University, Uganda.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Yofesi', 'Initials': 'Y', 'LastName': 'Nikweri', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute & London School of Hygiene and Tropical Medicine (MRC/UVRI & LSHTM), Uganda Research Unit, Masaka Station.'}, {'ForeName': 'Kathy Huppler', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]",Medical mycology,['10.1093/mmy/myaa033']
843,31907076,Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE): study protocol for a randomized controlled trial.,"BACKGROUND


IgA nephropathy (IgAN) is the most common glomerular disease worldwide. It has a high incidence in Asians and is more likely to progress to end-stage renal disease (ESRD). For high-risk IgAN, which is clinically characterized by massive proteinuria and renal dysfunction, however, there has been no international consensus on treatment options. Compared with other developed countries, IgAN patients in China are often found to have severe kidney function loss at initial diagnosis. Yi-Qi-Qing-Jie formula (YQF; a compound recipe of Chinese medicinal herbs) has shown potential renal protection in our previous clinical studies. To further confirm the efficacy and safety of YQF in the treatment of high-risk IgAN, we have designed a prospective double-blind randomized placebo-controlled trial.
METHODS/DESIGN


The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. We plan to randomize 60 participants with biopsy-proven IgAN to a YQF combined group (YQF compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression group (placebo-YQF combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter a 48-week in-trial treatment phase and receive post-trial follow-up until study completion (3 years). All patients will receive optimal supportive care. The primary composite outcome is defined as the first occurrence of a 40% decrease in estimated glomerular filtration rate (eGFR) from the baseline lasting for 3 months, initiating continuous renal replacement treatment, or death due to chronic kidney disease (CKD) during the 3-year study phase. The secondary endpoint events are defined as the mean annual eGFR decline rate (eGFR slope, ml/min per 1.73 m 2  per year), which is calculated by the eGFR regression curve for each eligible patient, and proteinuria remission (prescribed as proteinuria < 0.5 g/day) at weeks 24, 36, and 48 during the in-trial phase. The remission rate of symptoms and inflammation status will be evaluated at week 48. Safety monitoring and assessment will be undertaken during the study.
DISCUSSION


The TCM-WINE study will evaluate the effects and safety of YQF combined therapy compared with immunosuppression monotherapy on the basis of the optimal supportive treatment in high-risk IgAN. The evidence from this study will provide a novel, effective, and safe Chinese characteristic therapy for high-risk IgAN patients.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03418779. Registered on 18 June 2018.",2020,"Compared with other developed countries, IgAN patients in China are often found to have severe kidney function loss at initial diagnosis.","['high-risk IgAN', 'IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE', '60 participants with biopsy-proven IgAN to a']","['YQF combined therapy', 'Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies', 'YQF combined group (YQF compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression group (placebo-YQF combined with prednisolone, and cyclophosphamide if necessary', 'YQF', 'placebo', 'Yi-Qi-Qing-Jie formula (YQF', 'immunosuppression monotherapy']","['proteinuria remission', 'efficacy and safety', 'estimated glomerular filtration rate (eGFR', 'continuous renal replacement treatment, or death due to chronic kidney disease (CKD', 'mean annual eGFR decline rate (eGFR slope', 'remission rate of symptoms and inflammation status']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0017661', 'cui_str': 'Berger Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]","[{'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3811844'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",60.0,0.330101,"Compared with other developed countries, IgAN patients in China are often found to have severe kidney function loss at initial diagnosis.","[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Renal Division, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Bei Xian Ge St. Xi Cheng District, Beijing, 10053, China. lishen58173@163.com.""}, {'ForeName': 'Jin-Pu', 'Initials': 'JP', 'LastName': 'Li', 'Affiliation': ""Renal Division, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Bei Xian Ge St. Xi Cheng District, Beijing, 10053, China.""}]",Trials,['10.1186/s13063-019-3989-9']
844,31848837,What's in a Name? Evaluating the Public Stigma of Gambling Disorder.,"Public stigma of gambling disorder has negative effects on the mental health and functioning of affected individuals and impedes treatment-seeking. One factor thought to be implicated in stigma is the label used to describe the condition. The aims of this research were to: (1) evaluate whether different labels for problematic gambling behavior influence public stigma; and (2) compare public stigma of gambling disorder to other health conditions. Separate samples of university student (Study 1) and general population (Study 2) participants were randomly assigned to label conditions and completed questionnaires assessing stigma and attitudes towards the assigned label. In Study 1, the eight conditions included four gambling labels (problem gambling, pathological gambling, gambling disorder, and gambling addiction) and four psychiatric or health comparison labels (depression, obsessive-compulsive disorder, alcohol use disorder, and asthma). In Study 2, compulsive buying disorder was added as a fifth psychiatric comparison for a total of nine conditions. The results indicated that the four gambling label conditions elicited similar attitudes and stigma. Those conditions were also more stigmatized than the depression, obsessive-compulsive disorder, and asthma conditions. The gambling conditions elicited similar stigmatizing attitudes as alcohol use disorder but were slightly more stigmatized than compulsive buying disorder, with these conditions showing both similarities and differences across the stigma-related outcomes. The results were largely consistent across both samples and contribute to knowledge of the nature and origins of gambling-related stigma.",2020,"The gambling conditions elicited similar stigmatizing attitudes as alcohol use disorder but were slightly more stigmatized than compulsive buying disorder, with these conditions showing both similarities and differences across the stigma-related outcomes.","['eight conditions included four gambling labels (problem gambling, pathological gambling, gambling disorder, and gambling addiction) and four psychiatric or health comparison labels (depression, obsessive-compulsive disorder, alcohol use disorder, and asthma', 'Separate samples of university student (Study 1) and general population (Study 2) participants']",['label conditions and completed questionnaires assessing stigma and attitudes towards the assigned label'],['attitudes and stigma'],"[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0030662', 'cui_str': 'Gambling, Pathologic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",,0.0727245,"The gambling conditions elicited similar stigmatizing attitudes as alcohol use disorder but were slightly more stigmatized than compulsive buying disorder, with these conditions showing both similarities and differences across the stigma-related outcomes.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Quigley', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, 10461, USA. leanne.quigley@yu.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Prentice', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jonathan T', 'Initials': 'JT', 'LastName': 'Warren', 'Affiliation': 'Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY, 10461, USA.'}, {'ForeName': 'Lena C', 'Initials': 'LC', 'LastName': 'Quilty', 'Affiliation': 'Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Dobson', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, AB, Canada.'}]",Journal of gambling studies,['10.1007/s10899-019-09924-2']
845,27503091,Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients.,"BACKGROUND


Studies have reported liver injury as a consequence of antipsychotic treatment. Very heavy alcohol drinking (ten or more drinks/day for men and eight for women) also causes liver injury. This study aims to evaluate liver injury with quetiapine extended release (XR) in very heavy drinking alcohol-dependent (AD) patients.
METHODS


Two hundred and eighteen AD patients, 18-65 years of age, received 12 weeks of quetiapine XR or placebo treatment in a dose-escalated manner reaching the full dose of 400 mg/day during week 4. Blood chemistry and hematology were assessed at baseline (W0), post-titration at the end of week 3 (W4), week 8 (W8), and end of week 12 (W13). Patients were further grouped as GR.1 (no liver injury, ALT ≤40) and GR.2 (pre-existing liver injury, ALT >40) within each treatment. Drinking history, fasting blood glucose concentration (FBG), and lipid panel were used as covariates in the analyses.
RESULTS


Liver injury and total drinks and average drinking measures from the Timeline follow-back questionnaire (TLFB) were highly associated. No significant exacerbation in liver injury was observed in patients treated with quetiapine XR in GR.2. Liver injury as determined by elevated alanine aminotransaminase (ALT) was reported in a few patients in GR.1 who received quetiapine XR; however, the occurrence was low, and the level of liver injury was not significant. FBG and lipid measures showed some elevation, but did not show any significant association with liver injury.
CONCLUSION


Quetiapine XR did not show any significant exacerbation of liver injury in very heavy drinking alcohol-dependent patients with pre-existing liver injury. Frequency and severity of new liver injury cases in quetiapine XR-treated patients without any pre-existing liver injury was also low. Study findings support medical management of AD patients with heavy drinking profile using quetiapine XR formulation.",2016,No significant exacerbation in liver injury was observed in patients treated with quetiapine XR in GR.2.,"['AD patients with heavy drinking profile using quetiapine XR formulation', 'very heavy drinking alcohol-dependent (AD) patients', 'Two hundred and eighteen AD patients, 18-65\xa0years of age, received 12\xa0weeks of', 'Very Heavy Drinking Alcohol-Dependent Patients']","['Very heavy alcohol drinking', 'quetiapine XR', 'quetiapine XR or placebo', 'quetiapine extended release (XR', 'Quetiapine Fumarate XR Management', 'Quetiapine XR']","['elevated alanine aminotransaminase (ALT', 'liver injury', 'Blood chemistry and hematology', 'Drinking history, fasting blood glucose concentration (FBG), and lipid panel', 'Frequency and severity of new liver injury cases', 'Liver injury and total drinks and average drinking measures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0439540', 'cui_str': 'Very heavy (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439540', 'cui_str': 'Very heavy (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0724680', 'cui_str': 'Quetiapine fumarate'}]","[{'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",218.0,0.0199266,No significant exacerbation in liver injury was observed in patients treated with quetiapine XR in GR.2.,"[{'ForeName': 'Vatsalya', 'Initials': 'V', 'LastName': 'Vatsalya', 'Affiliation': 'Department of Medicine, University of Louisville School of Medicine, 505 S. Hancock St., CTR Room 521A, Louisville, KY, 40202, USA. v0vats01@exchange.louisville.edu.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': ""Department of Pediatric Gastroenterology, Maria Fareri Children's Hospital - Westchester Medical Center, Valhalla, NY, USA.""}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Cave', 'Affiliation': 'Department of Medicine, University of Louisville School of Medicine, 505 S. Hancock St., CTR Room 521A, Louisville, KY, 40202, USA.'}, {'ForeName': 'Shirish S', 'Initials': 'SS', 'LastName': 'Barve', 'Affiliation': 'Department of Medicine, University of Louisville School of Medicine, 505 S. Hancock St., CTR Room 521A, Louisville, KY, 40202, USA.'}, {'ForeName': 'Vijay A', 'Initials': 'VA', 'LastName': 'Ramchandani', 'Affiliation': 'Laboratory of Clinical and Translational Studies, Section on Human Psychopharmacology, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'Department of Medicine, University of Louisville School of Medicine, 505 S. Hancock St., CTR Room 521A, Louisville, KY, 40202, USA.'}]",Clinical drug investigation,[]
846,32415721,"Effect of screening, brief intervention and referral to treatment for unhealthy alcohol and other drug use in mental health treatment settings: a randomized controlled trial.","AIMS


To test the efficacy of a brief intervention to reduce alcohol or drug use and to promote use of addiction services among patients seeking mental health treatment.
DESIGN AND SETTING


A multi-centre, longitudinal, two-group randomized controlled trial with randomization within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA.
PARTICIPANTS


A total of 718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days.
INTERVENTION AND COMPARATOR


A motivation-based brief intervention with personalized feedback (screening, brief intervention and referral to treatment (SBIRT) condition) (n = 354) or a health education session (control condition) (n = 364).
MEASUREMENTS


Primary outcomes included frequency of heavy drinking days, days of cannabis use and days of stimulant use at the primary end-point 3 months post-baseline. Secondary outcomes included frequency and abstinence from substance use out to a 12-month follow-up and the use of addiction treatment services.
FINDINGS


Participants in the SBIRT condition had fewer heavy drinking days [odds ratio (OR) = 0.53; 95% credible interval (CrI) = 0.48-0.6] and fewer days of stimulant use (OR = 0.58; 95% CrI = 0.50-0.66) at the 3-month follow-up compared with participants in the health education condition. Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (OR = 0.93; 95% CrI = 0.85-1.01). Secondary outcomes indicated sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use. No effects were observed on abstinence rates or use of addiction treatment services.
CONCLUSIONS


Screening and brief intervention for unhealthy alcohol and drug use in mental health treatment settings were effective at reducing the frequency of heavy drinking and stimulant use.",2020,Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01).,"['718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days', 'Mental Health Treatment Settings', 'A multi-centre, longitudinal, two-group randomised controlled trial with randomisation within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA PARTICIPANTS', 'patients seeking mental health treatment']","['AND COMPARATOR\n\n\nA motivation-based brief intervention with personalized feedback (Screening, Brief Intervention and Referral to Treatment (SBIRT) condition) (n=354) or a health education session (control condition']","['abstinence rates or use of addiction treatment services', 'frequency of heavy drinking days, days of cannabis use and days of stimulant use', 'heavy drinking days', 'frequency and abstinence from substance use out to a 12-month follow up and the use of addiction treatment services', 'sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",718.0,0.0866086,Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3-month follow-up (odds ratio = 0.93; 95% CrI 0.85-1.01).,"[{'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Karno', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rawson', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Rogers', 'Affiliation': 'Department of Biostatistics and School of Nursing, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Spear', 'Affiliation': 'Department of Health Sciences, California State University, Northridge, CA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Grella', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Mooney', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Kagan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Glasner', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15114']
847,31563396,"Portable Accelerometer-Based Navigation System for Cup Placement of Total Hip Arthroplasty: A Prospective, Randomized, Controlled Study.","BACKGROUND


Malposition of the acetabular component during total hip arthroplasty (THA) is associated with increased risk of dislocation, reduced range of motion, and accelerated wear. The purpose of this study is to compare cup positioning with a portable, accelerometer-based hip navigation system and conventional surgical technique.
METHODS


In a prospective, randomized, clinical study, cups were implanted with a portable, accelerometer-based hip navigation system (navigation group; n = 55) or conventional technique (conventional group; n = 55). THA was conducted in the lateral position and through posterior approach. The cup position was determined postoperatively on pelvic radiograph and computed tomography scans.
RESULTS


An average cup abduction of 39.2° ± 4.6° (range, 27° to 50°) and an average cup anteversion of 14.6° ± 6.1° (range, 1° to 27.5°) were found in the navigation group, and an average cup abduction of 42.9° ± 8.0° (range, 23° to 73°) and an average cup anteversion of 11.6° ± 7.7° (range, -12.1° to 25°) in the conventional group. A smaller variation in the navigation group was indicated for cup abduction (P = .001). The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016). While only 37 of 55 cups in the conventional group were inside the Lewinnek safe zone, 51 of 55 cups in the navigation group were placed inside this safe zone (P = .006). The navigation procedure took a mean of 10 minutes longer than the conventional technique.
CONCLUSION


Use of the portable, accelerometer-based hip navigation system can improve cup positioning in THA.",2020,"The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016).","['Total Hip Arthroplasty', 'An average cup abduction of 39.2° ± 4.6° (range, 27° to 50°) and an average cup anteversion of 14.6° ± 6.1° (range, 1° to 27.5°) were found in the navigation group, and an average cup abduction of 42.9° ± 8.0° (range, 23° to 73°) and an average cup anteversion of 11.6° ± 7.7° (range']","['Portable Accelerometer-Based Navigation System', 'portable, accelerometer-based hip navigation system (navigation group; n\xa0= 55) or conventional technique (conventional group; n\xa0= 55', 'cup positioning with a portable, accelerometer-based hip navigation system and conventional surgical technique']",['cup abduction'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0333053', 'cui_str': 'Anteversion (morphologic abnormality)'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}]",,0.0281631,"The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016).","[{'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Tanino', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Mitsutake', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.044']
848,32412991,An Exploration of Health Behaviors in a Mind-Body Resilience Intervention for Parents of Children with Developmental Disabilities.,"OBJECTIVE


Parents of children with special needs such as learning and attentional disabilities (LADs) and autism spectrum disorder (ASD) are at high risk for stress-related disorders. The demands of parenting may compete with time for self-care behaviors such as physical activity, healthy eating, and adequate sleep. The objective was to describe health behaviors among this understudied population and assess the changes after a resilience intervention.
METHODS


This was a secondary data analysis of a randomized controlled pilot virtual mind-body resilience intervention (Stress Management and Resiliency Training: A Relaxation Response Resiliency Program) trial for parents of children with LADs (n = 52) and ASD (n = 47). Parents completed self-report questionnaires about their weekly physical activity, eating behaviors, sleep duration, and fatigue before and after the 8-week intervention. Descriptive statistics and pre-post intervention effect sizes (Cohen's d) were calculated.
RESULTS


Both parent groups reported suboptimal levels of health behaviors at baseline, but ASD parents reported lower health behaviors than LAD parents. LAD parents improved more on physical activity, with a higher percentage meeting recommendations at postintervention follow-up (d = 0.71) than ASD parents (d = 0.01). Eating behaviors showed small effect size improvements for both groups. Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81).
CONCLUSION


Parents of children with special needs who participated in a virtual resilience intervention demonstrated suboptimal health behaviors. There is a need for targeted interventions for health behaviors that can promote resilience in these high-stress populations.",2020,"Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81).
","['parents of children with LADs (n = 52) and ASD (n = 47', 'Parents of Children with Developmental Disabilities', 'Parents of children with special needs such as learning and attentional disabilities (LADs) and autism spectrum disorder (ASD', 'Parents of children with special needs who participated in a']","['body resilience intervention (Stress Management and Resiliency Training', 'Mind-Body Resilience Intervention', 'virtual resilience intervention']","['self-report questionnaires about their weekly physical activity, eating behaviors, sleep duration, and fatigue', 'sleep duration', 'physical activity', 'suboptimal health behaviors', 'health behaviors', 'suboptimal levels of health behaviors']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",52.0,0.0551803,"Although sleep duration improved only with small or medium effect sizes for both groups, ASD parents rated their fatigue lower after the intervention (d = 0.81).
","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Health Sciences, Northern Arizona University, Tucson, AZ.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Gabrielle N', 'Initials': 'GN', 'LastName': 'Schwartz', 'Affiliation': 'Health Policy Research Center, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kuhlthau', 'Affiliation': 'Division of General Academic Pediatrics, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000813']
849,27838224,"Inhibition of the hedgehog pathway in patients with basal-cell nevus syndrome: final results from the multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Aberrant hedgehog signalling underlies the development of basal-cell carcinomas. We previously reported the interim analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial in patients with the basal-cell nevus (Gorlin) syndrome indicating that the smoothened inhibitor vismodegib reduces basal-cell carcinoma tumour burden and prevents new basal-cell carcinoma growth in patients with basal-cell nevus syndrome. We report the final results of this 36 month trial.
METHODS


In our multicentre, randomised, double-blind, placebo-controlled, phase 2 trial we enrolled patients aged 35-75 years with basal-cell nevus syndrome with at least ten surgically eligible basal-cell carcinomas at the Children's Hospital Oakland, Columbia University outpatient dermatology clinic (NY, USA) and a private practice outpatient dermatology office in Newport Beach (CA, USA). Patients were assigned to vismodegib or placebo (2:1) according to a randomisation sequence generated by computer code. The primary endpoint of the trial of 41 patients was to compare the effect of oral vismodegib (150 mg/day) versus placebo on the incidence of new surgically eligible basal-cell carcinomas after 3 months of treatment. In the subsequent, open-label phase (n=37) patients continued vismodegib at two sites for as long as month 36 (n=25) and at the third site were monitored up to month 36 (n=12). Additional endpoints for this phase were: whether continuous versus interrupted dosing differentially affected tumour burden; time to reach various levels of reduction in tumour burden; reduction in tumour size in patients who took less than 50% of the expected number of vismodegib tablets; reduction in the number of surgical excisions required per year before, during, and after treatment; and the effect of vismodegib on hedgehog target gene expression. We monitored patients at visits every 3 months for up to 36 months. The primary endpoint was analysed on a modified intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00957229.
FINDINGS


Between Sept 22, 2009, and Jan 24, 2011, 41 patients were monitored for a median of 36 months (IQR 36-36). Patients treated with vismodegib (n=26) had a mean reduced rate of new surgically eligible basal-cell carcinomas compared with patients randomly assigned to placebo (n=15; two [SD 0·12] new surgically eligible basal-cell carcinomas per patient per year vs 34 [1·32] new surgically eligible basal-cell carcinomas per patient per year, p<0·0001). In the 11 patients initially assigned to placebo, mean cross over to vismodegib reduced the development of new surgically eligible basal-cell carcinomas compared with placebo (0·4 [SD 0·2] new surgically eligible basal-cell carcinomas per patient per year vs 30·0 [7·8] new surgically eligible basal-cell carcinomas per patient per year, p<0·0001). Only three (17%) of 18 patients tolerated vismodegib continuously for the full 36 months. Fewer new surgically eligible basal-cell carcinomas developed in patients receiving vismodegib continuously than in those who interrupted dosing (mean 0·6 [0·72] new surgically eligible basal-cell carcinomas per patient per year vs 1·7 [1·8] new surgically eligible basal-cell carcinomas per patient per year, p<0·0001). Treatment-related grade 3-4 adverse events included weight loss of 20% or more (n=6) and muscle cramps (n=2). Two patients died during the course of the trial, one each from laryngeal and metastatic prostate cancer, deemed probably unrelated to drug.
INTERPRETATION


Vismodegib reduces basal-cell carcinoma tumour burden in patients with basal-cell nevus syndrome. Adverse events associated with vismodegib frequently led to interruption of treatment, which is followed by basal-cell carcinoma recurrence.
FUNDING


Genentech investigator-initiated trial funding, Clinical and Translational Science Award from the National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, Damon Runyon Cancer Research Foundation Clinical Investigator Award, Swim across America Foundation, and Michael J Rainen Family Foundation.",2016,"In the 11 patients initially assigned to placebo, mean cross over to vismodegib reduced the development of new surgically eligible basal-cell carcinomas compared with placebo (0·4","['patients with the basal-cell nevus (Gorlin) syndrome indicating that the smoothened inhibitor vismodegib reduces basal-cell carcinoma tumour burden and prevents new basal-cell carcinoma growth in patients with basal-cell nevus syndrome', '0·72] new surgically eligible basal-cell carcinomas per patient per year vs 1·7', 'SD 0·2] new surgically eligible basal-cell carcinomas per patient per year vs 30·0', '1·8] new surgically eligible basal-cell carcinomas per patient per year, p<0·0001', 'patients with basal-cell nevus syndrome', 'Patients treated with vismodegib (n=26) had a mean reduced rate of new surgically eligible basal-cell carcinomas', '7·8', 'n=15; two [SD 0·12] new surgically eligible basal-cell carcinomas per patient per year vs 34 [1·32] new surgically eligible basal-cell carcinomas per patient per year, p<0·0001', ""enrolled patients aged 35-75 years with basal-cell nevus syndrome with at least ten surgically eligible basal-cell carcinomas at the Children's Hospital Oakland, Columbia University outpatient dermatology clinic (NY, USA) and a private practice outpatient dermatology office in Newport Beach (CA, USA""]","['oral vismodegib', 'vismodegib or placebo', 'placebo']","['weight loss of 20% or more (n=6) and muscle cramps', 'modified intention-to-treat basis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004779', 'cui_str': 'Fifth Phacomatosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2987716', 'cui_str': 'vismodegib'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3812390', 'cui_str': 'Dermatology clinic (environment)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2987716', 'cui_str': 'vismodegib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}]",41.0,0.533247,"In the 11 patients initially assigned to placebo, mean cross over to vismodegib reduced the development of new surgically eligible basal-cell carcinomas compared with placebo (0·4","[{'ForeName': 'Jean Y', 'Initials': 'JY', 'LastName': 'Tang', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA; Department of Dermatology Stanford University School of Medicine, Stanford, CA, USA.""}, {'ForeName': 'Mina S', 'Initials': 'MS', 'LastName': 'Ally', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA; Department of Dermatology Stanford University School of Medicine, Stanford, CA, USA.""}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Chanana', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Mackay-Wiggan', 'Affiliation': 'Department of Dermatology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Aszterbaum', 'Affiliation': 'Department of Dermatology University of California, Irvine, CA, USA.'}, {'ForeName': 'Joselyn A', 'Initials': 'JA', 'LastName': 'Lindgren', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ulerio', 'Affiliation': 'Department of Dermatology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Melika R', 'Initials': 'MR', 'LastName': 'Rezaee', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Gildengorin', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA.""}, {'ForeName': 'Jackleen', 'Initials': 'J', 'LastName': 'Marji', 'Affiliation': 'Department of Dermatology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Clark', 'Affiliation': 'Department of Dermatology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Bickers', 'Affiliation': 'Department of Dermatology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Ervin H', 'Initials': 'EH', 'LastName': 'Epstein', 'Affiliation': ""Children's Hospital of Oakland Research Institute, Oakland, CA, USA. Electronic address: eepstein@chori.org.""}]",The Lancet. Oncology,['10.1016/S1470-2045(16)30566-6']
850,31429950,Zero-balance ultrafiltration of the priming blood modifies the priming components and improves the clinical outcome in infants undergoing cardiopulmonary bypass: A randomized controlled trial.,"Cardiopulmonary bypass (CPB) requirement in infants presents a unique challenge because of the large prime volume-to-blood volume ratio. Packed red blood cells (PRBCs) tend to deteriorate with long-term storage owing to their unphysiological composition and osmolality. Given that blood priming is inevitable in neonates, it is suggested that the metabolic load and osmolality are diminished before CPB initiation. We conducted the present study to test the hypothesis that the zero-balance ultrafiltration (Z-BUF) of the priming blood with 0.45% saline might be sufficient for modifying the metabolic load and osmolality and, thus, achieving a physiological state. Sixty infants with a weight below 10 kg undergoing CPB were randomly assigned either to a control group or to a Z-BUF group and the Z-BUF of the priming blood was performed in the latter group. Electrolytes and osmolality were measured in the priming blood. The bleeding volume, the blood transfusion rate, the length of mechanical ventilation, the length of stay in the intensive care unit (ICU), the body temperature, and renal biomarkers were compared between the 2 groups. The osmolality and the levels of potassium, sodium, glucose, chloride, and lactate in the priming blood were significantly decreased after Z-BUF (P < .01). The Z-BUF group showed significant reductions in postoperative blood loss; postoperative blood transfusion; time to extubation; the length of stay in the ICU; the levels of lactate, sodium, and blood urea nitrogen at 24 hours postoperatively and the body temperature at 18 hours postoperatively (P < .05). However, no statistically significant differences were found between the 2 groups regarding the body temperature and the levels of serum creatinine and blood urea nitrogen after admission to the ICU. The results of the present study demonstrated that the Z-BUF of the priming blood could be a useful strategy in infants undergoing CPB insofar as it significantly modified the composition of the priming blood and improved the clinical outcome among our patients.",2020,"The Z-BUF group showed significant reductions in postoperative blood loss; postoperative blood transfusion; time to extubation; the length of stay in the ICU; the levels of lactate, sodium, and blood urea nitrogen at 24 hours postoperatively and the body temperature at 18 hours postoperatively (P<0.05).","['Infants Undergoing Cardiopulmonary Bypass', 'Sixty infants with a weight below 10 kg undergoing CPB']","['Cardiopulmonary bypass (CPB', 'control group or to a Z-BUF']","['Electrolytes and osmolality', 'bleeding volume, the blood transfusion rate, the length of mechanical ventilation, the length of stay in the intensive care unit (ICU), the body temperature, and renal biomarkers', 'body temperature and the levels of serum creatinine and blood urea nitrogen', 'levels of lactate, sodium, and blood urea nitrogen', 'postoperative blood loss; postoperative blood transfusion', 'Packed red blood cells (PRBCs', 'osmolality and the levels of potassium, sodium, glucose, chloride, and lactate in the priming blood']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C4301987', 'cui_str': 'Osmolality (property)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}, {'cui': 'C0005768'}]",60.0,0.0258029,"The Z-BUF group showed significant reductions in postoperative blood loss; postoperative blood transfusion; time to extubation; the length of stay in the ICU; the levels of lactate, sodium, and blood urea nitrogen at 24 hours postoperatively and the body temperature at 18 hours postoperatively (P<0.05).","[{'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Gholampour Dehaki', 'Affiliation': 'Department of Pediatric Cardiac Surgery, Rajaei Cardiovascular Medical and Research Center, Tehran, Iran.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Niknam', 'Affiliation': 'Department of Clinical Research Development Unit of Besat Hospital, Hamadan University of Medical Sciences Medical School, Hamadan, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Department of Epidemiology and Biostatistics, Rajaei Cardiovascular Medical and Research Center, Tehran, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Azarfarin', 'Affiliation': 'Department of Cardiac Anesthesia, Rajaei Cardiovascular Medical and Research Center, Tehran, Iran.'}]",Artificial organs,['10.1111/aor.13559']
851,27725164,Tamoxifen for the treatment of breakthrough bleeding with the etonogestrel implant: a randomized controlled trial.,"OBJECTIVE


The etonogestrel (ENG) subdermal implant can cause frequent breakthrough bleeding in some users. The objective of this study was to evaluate whether a short course of tamoxifen reduces bleeding/spotting days compared to placebo in ENG implant users.
STUDY DESIGN


In this double-blind trial, we randomized ENG implant users with frequent or prolonged bleeding or spotting to tamoxifen 10 mg or placebo twice daily for 7 days, to be started after 3 consecutive days of bleeding/spotting. Treatment was repeated as needed up to three times in 180 days. Subjects completed a daily text message bleeding diary. A sample size of 56 provided 80% power to detect a difference of 6 days of bleeding/spotting per 30 days by two-sample t test. Ovulation was monitored by urinary metabolites of progesterone.
RESULTS


From March 2014 to February 2015, 56 women enrolled. Fifty-one completed at least 30 days of follow up, and 34 completed 180 days. Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] -9.9 to -0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8-27.5 days, p=.02) after first use of study drug. Conclusions could not be drawn after 30 days due to higher-than-expected dropout. No ovulation was detected.
CONCLUSION


First use of tamoxifen by ENG implant users reduces bleeding/spotting days and provides a longer cessation of bleeding/spotting than placebo, without compromising ovulation suppression. Further study is needed to determine whether this effect is maintained with repeat use.
IMPLICATIONS


Women with frequent ENG implant-related breakthrough bleeding may experience a reduction in bleeding/spotting days and an increase in continuous bleeding-free days in the month following first use of tamoxifen. This short course of tamoxifen was well tolerated with bleeding cessation noted within a median of 5 days.",2017,"Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] -9.9 to -0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8-27.5 days, p=.02) after first use of study drug.","['breakthrough bleeding with the etonogestrel implant', 'ENG implant users with frequent or prolonged bleeding or spotting to', 'ENG implant users', 'From March 2014 to February 2015, 56 women enrolled']","['Tamoxifen', 'placebo', 'tamoxifen', 'tamoxifen 10 mg or placebo']","['bleeding/spotting', 'bleeding/spotting days', 'Ovulation']","[{'cui': 'C3495440', 'cui_str': 'Break-through bleeding (finding)'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1596572', 'cui_str': 'Tamoxifen 10 MG [Nolvadex]'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",56.0,0.582442,"Compared to women randomized to placebo, women randomized to tamoxifen reported 5 fewer days of bleeding/spotting over 30 days (95% confidence interval [CI] -9.9 to -0.05, p=.05), and 15.2 more continuous bleeding-free days (95% CI 2.8-27.5 days, p=.02) after first use of study drug.","[{'ForeName': 'Katharine B', 'Initials': 'KB', 'LastName': 'Simmons', 'Affiliation': 'Oregon Health & Science University, Department of Obstetrics and Gynecology, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA. Electronic address: simmonka@ohsu.edu.'}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Edelman', 'Affiliation': 'Oregon Health & Science University, Department of Obstetrics and Gynecology, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA.'}, {'ForeName': 'Rongwei', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'Oregon Health & Science University, School of Public Health, 3181 SW Sam Jackson Park Road, CB669, Portland, OR 97239, USA; Oregon Health & Science University, Department of Emergency Medicine, 3181 SW Sam Jackson Park Road, CDW-EM, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Oregon Health & Science University, Department of Obstetrics and Gynecology, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA.'}]",Contraception,['10.1016/j.contraception.2016.10.001']
852,27943220,Population Pharmacokinetics and Exploratory Pharmacodynamics of Lorazepam in Pediatric Status Epilepticus.,"BACKGROUND


Lorazepam is one of the preferred agents used for intravenous treatment of status epilepticus (SE). We combined data from two pediatric clinical trials to characterize the population pharmacokinetics of intravenous lorazepam in infants and children aged 3 months to 17 years with active SE or a history of SE.
METHODS


We developed a population pharmacokinetic model for lorazepam using the NONMEM software. We then assessed exploratory exposure-response relationships using the overall efficacy and safety study endpoints, and performed dosing simulations.
RESULTS


A total of 145 patients contributed 439 pharmacokinetic samples. The median (range) age and dose were 5.4 years (0.3-17.8) and 0.10 mg/kg (0.02-0.18), respectively. A two-compartment pharmacokinetic model with allometric scaling described the data well. In addition to total body weight (WT), younger age was associated with slightly higher weight-normalized clearance (CL). The following relationships characterized the typical values for the central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q), using individual subject WT (kg) and age (years): V1 (L) = 0.879*WT; CL (L/h) = 0.115*(Age/4.7) 0.133 *WT 0.75 ; V2 (L) = 0.542*V1; Q (L/h) = 1.45*WT 0.75 . No pharmacokinetic parameters were associated with clinical outcomes. Simulations suggest uniform pediatric dosing (0.1 mg/kg, to a maximum of 4 mg) can be used to achieve concentrations of 50-100 ng/mL in children with SE, which have been previously associated with effective seizure control.
CONCLUSIONS


The population pharmacokinetics of lorazepam were successfully described using a sparse sampling approach and a two-compartment model in pediatric patients with active SE.",2017,No pharmacokinetic parameters were associated with clinical outcomes.,"['pediatric patients with active SE', 'infants and children aged 3\xa0months to 17\xa0years with active SE or a history of SE', 'Pediatric Status Epilepticus', '145 patients contributed 439 pharmacokinetic samples']","['Lorazepam', 'lorazepam']","['weight-normalized clearance (CL', 'central compartment volume (V1), CL, peripheral compartment volume (V2), and intercompartmental CL (Q']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.118065,No pharmacokinetic parameters were associated with clinical outcomes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cohen-Wolkowiez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Barrie', 'Initials': 'B', 'LastName': 'Harper', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics and Skaggs School of Pharmacy, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093-0831, USA. ecapparelli@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacokinetics,['10.1007/s40262-016-0486-0']
853,27459380,The Moderating Effect of State Anger on Treatment Outcome in Female Adolescents With PTSD.,"Trauma experienced in childhood and adolescence negatively affects the development of adaptive regulation of emotions and is associated with greater symptoms of anger. Prior research has suggested that high levels of anger may impede the outcome of treatment in adults with posttraumatic stress disorder (PTSD). The current study investigated whether high levels of anger resulted in poorer treatment outcomes in adolescent girls with PTSD. Participants included 61 female adolescent survivors of sexual abuse or assault who were randomized to either prolonged exposure for adolescents (PE-A) or client-centered therapy (CCT) for traumatized children for 8-14 weekly sessions. Participants were followed for 12 months posttreatment. High levels of state anger at baseline were associated with less improvement in PTSD symptoms in the CCT group than the PE-A group (d = 0.62). The moderating effects of state anger on improvement in PTSD symptoms was significant with emotion regulation difficulties, which may underlie anger symptoms (d = 0.58) in the model. The results of this study suggessted that high state anger was less of an impediment to treatment of PTSD for those receiving PE-A than those receiving less differentiated approaches such as CCT.",2016,High levels of state anger at baseline were associated with less improvement in PTSD symptoms in the CCT group than the PE-A group (d = 0.62).,"['adults with posttraumatic stress disorder (PTSD', 'Participants included 61 female adolescent survivors of sexual abuse or assault who were randomized to either', 'adolescent girls with PTSD', 'Female Adolescents With PTSD']","['prolonged exposure for adolescents (PE-A) or client-centered therapy (CCT', 'State Anger']","['High levels of state anger', 'PTSD symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0004063', 'cui_str': 'Assault (event)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028302', 'cui_str': 'Nondirective Therapy'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Anger'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",61.0,0.0262197,High levels of state anger at baseline were associated with less improvement in PTSD symptoms in the CCT group than the PE-A group (d = 0.62).,"[{'ForeName': 'Antonia N', 'Initials': 'AN', 'LastName': 'Kaczkurkin', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Asnaani', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Journal of traumatic stress,['10.1002/jts.22116']
854,27891089,"Effect of Probiotic Supplementation on Cognitive Function and Metabolic Status in Alzheimer's Disease: A Randomized, Double-Blind and Controlled Trial.","Alzheimer's disease (AD) is associated with severe cognitive impairments as well as some metabolic defects. Scant studies in animal models indicate a link between probiotics and cognitive function. This randomized, double-blind, and controlled clinical trial was conducted among 60 AD patients to assess the effects of probiotic supplementation on cognitive function and metabolic status. The patients were randomly divided into two groups ( n  = 30 in each group) treating with either milk (control group) or a mixture of probiotics (probiotic group). The probiotic supplemented group took 200 ml/day probiotic milk containing  Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum , and  Lactobacillus fermentum  (2 × 10 9  CFU/g for each) for 12 weeks. Mini-mental state examination (MMSE) score was recorded in all subjects before and after the treatment. Pre- and post-treatment fasting blood samples were obtained to determine the related markers. After 12 weeks intervention, compared with the control group (-5.03% ± 3.00), the probiotic treated (+27.90% ± 8.07) patients showed a significant improvement in the MMSE score ( P  <0.001). In addition, changes in plasma malondialdehyde (-22.01% ± 4.84 vs. +2.67% ± 3.86 μmol/L,  P  <0.001), serum high-sensitivity C-reactive protein (-17.61% ± 3.70 vs. +45.26% ± 3.50 μg/mL,  P  <0.001), homeostasis model of assessment-estimated insulin resistance (+28.84% ± 13.34 vs. +76.95% ± 24.60,  P  = 0.002), Beta cell function (+3.45% ± 10.91 vs. +75.62% ± 23.18,  P  = 0.001), serum triglycerides (-20.29% ± 4.49 vs. -0.16% ± 5.24 mg/dL,  P  = 0.003), and quantitative insulin sensitivity check index (-1.83 ± 1.26 vs. -4.66 ± 1.70,  P  = 0.006) in the probiotic group were significantly varied compared to the control group. We found that the probiotic treatment had no considerable effect on other biomarkers of oxidative stress and inflammation, fasting plasma glucose, and other lipid profiles. Overall, the current study demonstrated that probiotic consumption for 12 weeks positively affects cognitive function and some metabolic statuses in the AD patients.
CLINICAL TRIAL REGISTRATION


http://www.irct.ir/, IRCT201511305623N60.",2016,"After 12 weeks intervention, compared with the control group (-5.03% ± 3.00), the probiotic treated (+27.90% ± 8.07) patients showed a significant improvement in the MMSE score ( P  <0.001).","['60 AD patients', ""Alzheimer's disease (AD"", ""Alzheimer's Disease""]","['probiotic supplementation', 'probiotic supplemented group took 200 ml/day probiotic milk containing  Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum , and  Lactobacillus fermentum', 'milk (control group) or a mixture of probiotics (probiotic group', 'Probiotic Supplementation']","['serum high-sensitivity C-reactive protein', 'Beta cell function', 'quantitative insulin sensitivity check index', 'cognitive function and some metabolic statuses', 'homeostasis model of assessment-estimated insulin resistance', 'serum triglycerides', 'cognitive function and metabolic status', 'oxidative stress and inflammation, fasting plasma glucose, and other lipid profiles', 'Cognitive Function and Metabolic Status', 'Mini-mental state examination (MMSE) score', 'plasma malondialdehyde', 'MMSE score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439446', 'cui_str': 'mL/day'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0317603', 'cui_str': 'Lactobacillus fermentum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0726377,"After 12 weeks intervention, compared with the control group (-5.03% ± 3.00), the probiotic treated (+27.90% ± 8.07) patients showed a significant improvement in the MMSE score ( P  <0.001).","[{'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Akbari', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Daneshvar Kakhaki', 'Affiliation': 'Department of Neurology, School of Medicine, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Department of Neurology, School of Medicine, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Gholam Ali', 'Initials': 'GA', 'LastName': 'Hamidi', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences Kashan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Salami', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences Kashan, Iran.'}]",Frontiers in aging neuroscience,[]
855,27401564,Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams.,"Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly. Fluconazole plasma concentrations from samples obtained by either scheduled or scavenged sampling were measured using a liquid chromatography-tandem mass spectrometry assay. Population PK analysis was conducted using NONMEM 7.2. Population PK parameters were allometrically scaled by body weight. Covariates were evaluated by univariable screening followed by multivariable assessment. Fluconazole exposures were simulated in premature infants using the final PK model. A population PK model was developed from 141 infants using 604 plasma samples. Plasma fluconazole PK were best described by a one-compartment model with first-order elimination. Only serum creatinine was an independent predictor for clearance in the final model. The typical population parameter estimate for oral bioavailability in the final model was 99.5%. Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples. Simulations indicated that the study dose maintained fluconazole troughs of >2,000 ng/ml in 80% of simulated infants at week 1 and 59% at week 4 of treatment. Developmental changes in fluconazole clearance are best predicted by serum creatinine in this population. A twice-weekly dose of 6 mg/kg achieves appropriate levels for prevention of invasive candidiasis in extremely premature infants.",2016,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"['premature infants using the final PK model', 'extremely premature infants', '141 infants using 604 plasma samples', 'infants with birth weights of <750 g', 'premature infants', 'Premature Infants with Birth Weights Less than 750 Grams', 'infants born at <750 g birth weight received']","['fluconazole', 'intravenous (i.v.) or oral fluconazole', 'Fluconazole']","['oral bioavailability', 'Fluconazole plasma concentrations']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0306005,Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples.,"[{'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Wade', 'Affiliation': ""Children's Hospital of Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kantak', 'Affiliation': ""Children's Hospital Medical Center of Akron, Akron, Ohio, USA.""}, {'ForeName': 'Ramasubbareddy', 'Initials': 'R', 'LastName': 'Dhanireddy', 'Affiliation': 'University of Tennessee Health System, Memphis, Tennessee, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'East Carolina University, Brody School of Medicine, Greenville, North Carolina, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Nedrelow', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, Texas, USA.""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, Florida, USA.'}, {'ForeName': 'Gratias T', 'Initials': 'GT', 'LastName': 'Mundakel', 'Affiliation': 'Kings County Hospital, Brooklyn, New York, USA.'}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': 'Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Laughon', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'P Brian', 'Initials': 'PB', 'LastName': 'Smith', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA brian.smith@duke.edu.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA Duke Clinical Research Institute, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00963-16']
856,29215909,Caring for the elderly at work and home: Can a randomized organizational intervention improve psychological health?,"Although job stress models suggest that changing the work social environment to increase job resources improves psychological health, many intervention studies have weak designs and overlook influences of family caregiving demands. We tested the effects of an organizational intervention designed to increase supervisor social support for work and nonwork roles, and job control in a results-oriented work environment on the stress and psychological distress of health care employees who care for the elderly, while simultaneously considering their own family caregiving responsibilities. Using a group-randomized organizational field trial with an intent-to-treat design, 420 caregivers in 15 intervention extended-care nursing facilities were compared with 511 caregivers in 15 control facilities at 4 measurement times: preintervention and 6, 12, and 18 months. There were no main intervention effects showing improvements in stress and psychological distress when comparing intervention with control sites. Moderation analyses indicate that the intervention was more effective in reducing stress and psychological distress for caregivers who were also caring for other family members off the job (those with elders and those ""sandwiched"" with both child and elder caregiving responsibilities) compared with employees without caregiving demands. These findings extend previous studies by showing that the effect of organizational interventions designed to increase job resources to improve psychological health varies according to differences in nonwork caregiving demands. This research suggests that caregivers, especially those with ""double-duty"" elder caregiving at home and work and ""triple-duty"" responsibilities, including child care, may benefit from interventions designed to increase work-nonwork social support and job control. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Moderation analyses indicate that the intervention was more effective in reducing stress and psychological distress for caregivers who were also caring for other family members off the job (those with elders and those ""sandwiched"" with both child and elder caregiving responsibilities) compared with employees without caregiving demands.","['420 caregivers in 15 intervention extended-care nursing facilities were compared with 511 caregivers in 15 control facilities at 4 measurement times: preintervention and 6, 12, and 18 months', 'health care employees who care for the elderly, while simultaneously considering their own family caregiving responsibilities']",['organizational intervention'],['stress and psychological distress'],"[{'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0150083,"Moderation analyses indicate that the intervention was more effective in reducing stress and psychological distress for caregivers who were also caring for other family members off the job (those with elders and those ""sandwiched"" with both child and elder caregiving responsibilities) compared with employees without caregiving demands.","[{'ForeName': 'Ellen Ernst', 'Initials': 'EE', 'LastName': 'Kossek', 'Affiliation': 'Krannert School of Management, Purdue University.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Thompson', 'Affiliation': 'Department of Applied Behavioral Sciences, University of Baltimore.'}, {'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Lawson', 'Affiliation': 'Department of Psychological Science, Ball State University.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Bodner', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Perrigino', 'Affiliation': 'Department of Management, Purdue University.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Hammer', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Almeida', 'Affiliation': 'Department of Human Development and Family Studies, The Pennsylvania State University.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Moen', 'Affiliation': 'Department of Sociology, University of Minnesota.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hurtado', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health & Science University.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wipfli', 'Affiliation': 'School of Public Health, Portland State University.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Berkman', 'Affiliation': 'Center for Population and Development Studies, Harvard University.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Bray', 'Affiliation': 'Department of Economics, University of North Carolina at Greensboro.'}]",Journal of occupational health psychology,['10.1037/ocp0000104']
857,32069288,Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.,"BACKGROUND


Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation.
METHODS AND FINDINGS


We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes.
CONCLUSIONS


In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted.
TRIAL REGISTRATION


The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.",2020,"Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life.","['Australia', 'Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation', 'people with mobility limitations admitted to aged care and neurological rehabilitation', '258 participants (129 intervention, 129 control', '3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation']","['intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices', 'secure online database (REDCap', 'average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge', 'usual multidisciplinary inpatient and post-hospital rehabilitation care']","['self-reported balance confidence and quality of life', 'upright time', 'adverse events', 'risk of a type I error; and potential low statistical power', 'Changes in mobility scores', 'mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1828349', 'cui_str': 'Using device'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1136005', 'cui_str': 'Computers, Handheld'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019728', 'cui_str': 'HLA-A'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.158428,"Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maayken', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McCluskey', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Department of Public & Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Stuart T', 'Initials': 'ST', 'LastName': 'Smith', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Coffs Harbour, New South Wales, Australia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schurr', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Killington', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Bongers', 'Affiliation': 'Faculty of Design, Architecture and Building, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': 'School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Treacy', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Dorsch', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Scrivener', 'Affiliation': 'StrokeEd Collaboration, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sakina', 'Initials': 'S', 'LastName': 'Chagpar', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pinheiro', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heritier', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003029']
858,26916481,"Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors.","BACKGROUND


Recent reports suggest an elevated incidence of bioresorbable vascular scaffold (BVS) thrombosis (scaffold thrombosis [ScT]).
OBJECTIVES


This study investigated occurrence rates, clinical and angiographic characteristics, and possible mechanisms of ScT in all-comer patients undergoing BVS implantation at 2 German and 2 Swiss hospitals.
METHODS


A total of 1,305 consecutive patients (mean age 64 years, 78% male) who received 1,870 BVS (mean 1.4 ± 0.8 BVS/patient) were enrolled. Clinical/procedural characteristics, mortality, and ScT data at 485 days (range 312 to 652 days) were examined.
RESULTS


ScT occurred in 42 patients. The incidence of probable and definite ScT was 1.8% at 30 days and 3.0% at 12 months, without differences among centers (p = 0.60). A total of 22 (52%) ScTs presented as ST-segment elevation myocardial infarction and 6 (17%) as sudden cardiac death. In multivariable analysis, ostial lesions (p = 0.049) and impaired left ventricular ejection fraction (p = 0.019) were independently associated with ScT. Nine (21%) of the ScTs occurred in patients who had suspended dual antiplatelet therapy, in 6 cases prematurely. Lower post-procedural minimum lumen and reference vessel diameters were hallmarks of ScT (all p < 0.0001). The risk of ScT appeared to rapidly increase for post-procedural minimum lumen diameters below 2.4 mm (for the 2.5- to 3.0-mm BVS) and 2.8 mm (for the 3.5-mm BVS). When a BVS-specific implantation strategy was implemented, 12-month ScT rates fell from 3.3% to 1.0%, an effect that remained significant when adjusted for multivariable propensity score (p = 0.012; hazard ratio: 0.19; 95% confidence interval: 0.05 to 0.70).
CONCLUSIONS


The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed. (retrospective multicentric registry and Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178).",2016,The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed.,"['all-comer patients undergoing BVS implantation at 2 German and 2 Swiss hospitals', '1,305 consecutive patients (mean age 64 years, 78% male) who received 1,870 BVS (mean 1.4 ± 0.8 BVS/patient) were enrolled']",[],"['12-month ScT rates fell', 'ST-segment elevation myocardial infarction', 'left ventricular ejection fraction', 'risk of ScT', 'sudden cardiac death', 'incidence of probable and definite ScT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}]",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}]",1305.0,0.154653,The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed.,"[{'ForeName': 'Serban', 'Initials': 'S', 'LastName': 'Puricel', 'Affiliation': 'Department of Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Weissner', 'Affiliation': 'Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Schmermund', 'Affiliation': 'Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany.'}, {'ForeName': 'Peiman', 'Initials': 'P', 'LastName': 'Jamshidi', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nyffenegger', 'Affiliation': 'Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Binder', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Eggebrecht', 'Affiliation': 'Cardioangiologisches Centrum Bethanien, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University & Hospital Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Zentrum für Kardiologie, University Hospital Mainz, Mainz, Germany, and German Center for Cardiac and Vascular Research (DZHK), Standort Rhein-Main, Mainz, Germany. Electronic address: tommaso.gori@unimedizin-mainz.de.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2015.12.019']
859,27426247,"Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial.","BACKGROUND


Few weight loss interventions are evaluated for longer than a year, and even fewer employ social and mobile technologies commonly used among young adults. We assessed the efficacy of a 2 year, theory-based, weight loss intervention that was remotely and adaptively delivered via integrated user experiences with Facebook, mobile apps, text messaging, emails, a website, and technology-mediated communication with a health coach (the SMART intervention).
METHODS


In this parallel-group, randomised, controlled trial, we enrolled overweight or obese college students (aged 18-35 years) from three universities in San Diego, CA, USA. Participants were randomly assigned (1:1) to receive either the intervention (SMART intervention group) or general information about health and wellness (control group). We used computer-based permuted-block randomisation with block sizes of four, stratified by sex, ethnicity, and college. Participants, study staff, and investigators were masked until the intervention was assigned. The primary outcome was objectively measured weight in kg at 24 months. Differences between groups were evaluated using linear mixed-effects regression within an intention-to-treat framework. Objectively measured weight at 6, 12, and 18 months was included as a secondary outcome. The trial is registered with ClinicalTrials.gov, number NCT01200459.
FINDINGS


Between May 18, 2011, and May 17, 2012, 404 individuals were randomly assigned to the intervention (n=202) or control (n=202). Participants' mean (SD) age was 22·7 (3·8) years. 284 (70%) participants were female and 125 (31%) were Hispanic. Mean (SD) body-mass index at baseline was 29·0 (2·8) kg/m(2). At 24 months, weight was assessed in 341 (84%) participants, but all 404 were included in analyses. Weight, adjusted for sex, ethnicity, and college, was not significantly different between the groups at 24 months (-0·79 kg [95% CI -2·02 to 0·43], p=0·204). However, weight was significantly less in the intervention group compared with the control group at 6 months (-1·33 kg [95% CI -2·36 to -0·30], p=0·011) and 12 months (-1·33 kg [-2·30 to -0·35], p=0·008), but not 18 months (-0·67 kg [95% CI -1·69 to 0·35], p=0·200). One serious adverse event in the intervention group (gallstones) could be attributable to rapid and excessive weight loss.
INTERPRETATION


Social and mobile technologies did not facilitate sustained reductions in weight among young adults, although these approaches might facilitate limited short-term weight loss.
FUNDING


The National Heart, Lung, and Blood Institute of the National Institutes of Health (U01 HL096715).",2016,"However, weight was significantly less in the intervention group compared with the control group at 6 months (-1·33 kg","[""Participants' mean (SD) age was 22·7 (3·8) years"", 'overweight and obese young adults', 'enrolled overweight or obese college students (aged 18-35 years) from three universities in San Diego, CA, USA', '284 (70%) participants were female and 125 (31%) were Hispanic', 'Between May 18, 2011, and May 17, 2012, 404 individuals were randomly assigned to the intervention (n=202) or control (n=202', 'young adults']","['weight loss intervention that was remotely and adaptively delivered via integrated user experiences with Facebook, mobile apps, text messaging, emails, a website, and technology-mediated communication with a health coach (the SMART intervention', 'intervention (SMART intervention group) or general information about health and wellness (control group']","['weight in kg at 24 months', 'Mean (SD) body-mass index', 'weight', 'weight loss']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",404.0,0.214947,"However, weight was significantly less in the intervention group compared with the control group at 6 months (-1·33 kg","[{'ForeName': 'Job G', 'Initials': 'JG', 'LastName': 'Godino', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Merchant', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Norman', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Donohue', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Marshall', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Fowler', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Division of Global Public Health, University of California, San Diego, La Jolla, CA, USA; Department of Political Science, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Calfas', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jeannie S', 'Initials': 'JS', 'LastName': 'Huang', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Division of Pediatric Gastroenterology, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Rock', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Griswold', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Development, Aging, and Regeneration, Sanford Burnham Prebys Medical Discovery Institute, La Jolla, CA, USA.'}, {'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Raab', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Fogg', 'Affiliation': 'Behavior Design Laboratory, Human Sciences and Technologies Advanced Research Institute, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Robinson', 'Affiliation': 'Stanford Solutions Science Laboratory, Department of Pediatrics, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'Center for Wireless and Population Health Systems, University of California, San Diego, La Jolla, CA, USA; Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA, USA. Electronic address: kpatrick@ucsd.edu.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(16)30105-X']
860,27220976,Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.,"BACKGROUND


The purpose of this study was to examine the effectiveness and cost-efficiency of a tailored message intervention compared with a non-tailored message intervention for increasing colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program.
METHODS


After a baseline survey for psychological segmentation, 2140 eligible individuals were randomly assigned either to a group with a tailored matched-message condition (N = 356), a group with a non-tailored unmatched-message condition (N = 355), or to two control groups, one using a typical message with a professional design (N = 717) and one without a professional design (N = 712). The main outcome measure was attendance rates in a community-organized CRC screening program within five months of receiving a print reminder.
RESULTS


There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219). The cost of a one-person increase in FOBT screening was 3,740 JPY for the tailored matched-message condition, while it was 2,747 JPY for the control.
CONCLUSIONS


A tailored-message intervention for segmented individuals designed to increase CRC screening rates in a community-based client reminder program was significantly effective compared to a usual reminder, but not more effective than an unmatched message in a randomized controlled trial, and was not sufficiently effective to highlight its value from a cost perspective. Therefore, the tailored intervention including target segmentation needs to be improved for future implementation in a CRC screening program for a non-adherent population.
TRIAL REGISTRATION


UMIN Clinical Trials Registry UMIN000004384 . Date of Registration: March 2011.",2016,"There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219).","['colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program', '2140 eligible individuals', 'colorectal cancer screening among a non-adherent population']","['tailored matched-message condition (N\u2009=\u2009356), a group with a non-tailored unmatched-message condition (N\u2009=\u2009355), or to two control groups, one using a typical message with a professional design (N\u2009=\u2009717) and one without a professional design', 'tailored message intervention compared with a non-tailored message intervention', 'Tailored message interventions versus typical messages']","['effectiveness and cost-efficiency', 'attendance rates in a community-organized CRC screening program within five months of receiving a print reminder', 'cost of a one-person increase in FOBT screening', 'CRC screening rates', 'fecal occult blood test (FOBT) attendance rates']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0631839,"There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219).","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': 'Graduate School of Human Sciences, and Graduate School of Medicine, Osaka University, 2-2, Yamadaoka, Suita-shi, Osaka, 565-0871, Japan. khirai@grappo.jp.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Health and Social Behavior, School of Public Health, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fukuyoshi', 'Affiliation': 'Cancer Scan, Tokyo, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Yonekura', 'Affiliation': 'Cancer Scan, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Graduate School of Human Development and Environment, Kobe University, Kobe, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibuya', 'Affiliation': 'Cancer Detection Center, Miyagi Cancer Society, Miyagi, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Public Health Policy Research Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Mizota', 'Affiliation': 'Public Health Policy Research Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Hamashima', 'Affiliation': 'Screening Assessment and Management Division, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Screening Assessment and Management Division, National Cancer Center, Tokyo, Japan.'}]",BMC public health,['10.1186/s12889-016-3069-y']
861,26916483,Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel.,"BACKGROUND


Certain alleles of the CYP2C19 gene are associated with higher platelet reactivity and increased ischemic events among patients treated with clopidogrel. However, the relationship of CYP2C19 genotype and outcomes in medically managed patients with acute coronary syndromes (ACS) is not known.
OBJECTIVES


This study sought to assess the effect of CYP2C19 genotype on ischemic outcomes in patients with ACS initially managed medically without revascularization who were randomized to either clopidogrel or prasugrel.
METHODS


We classified patients as extensive metabolizers (EM) or reduced metabolizers (RM) based on CYP2C19 genotype and evaluated ischemic outcomes and platelet reactivity. Among 9,326 patients enrolled from 2008 to 2011, 5,736 participated in the genetics cohort; of these, 2,236 had platelet function testing data.
RESULTS


There was no association between CYP2C19 metabolizer status (EM vs. RM) and the primary composite endpoint of cardiovascular death, myocardial infarction (MI), or stroke (hazard ratio [HR]: 0.86). EM and RM patients had similar rates of the primary endpoint whether treated with prasugrel (HR: 0.82) or clopidogrel (HR: 0.91; p for interaction = 0.495). After adjusting for clinical and treatment variables, EM patients had a lower risk of MI versus RM patients (HR: 0.80), but risks of other outcomes were similar. RM patients had significantly higher mean P2Y12 reaction units versus EM patients when treated with clopidogrel (39.93), but not with prasugrel (3.87).
CONCLUSIONS


CYP2C19 metabolizer status is not associated with the composite outcome of cardiovascular death, MI, or stroke in medically managed ACS patients treated with clopidogrel or prasugrel. Our findings do not support routine CYP2C19 genetic testing in this population. (A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects [TRILOGY ACS]; NCT00699998).",2016,"RM patients had significantly higher mean P2Y12 reaction units versus EM patients when treated with clopidogrel (39.93), but not with prasugrel (3.87).
","['patients with ACS initially managed medically without revascularization', '9,326 patients enrolled from 2008 to 2011, 5,736 participated in the genetics cohort; of these, 2,236 had platelet function testing data', 'patients treated with', 'medically managed patients with acute coronary syndromes (ACS', 'Patients With ACS Treated With']","['clopidogrel or prasugrel', 'Prasugrel and Clopidogrel', 'Prasugrel Versus Clopidogrel', 'clopidogrel', 'CYP2C19 genotype']","['extensive metabolizers (EM) or reduced metabolizers (RM) based on CYP2C19 genotype and evaluated ischemic outcomes and platelet reactivity', 'cardiovascular death, MI, or stroke', 'cardiovascular death, myocardial infarction (MI), or stroke', 'ischemic events', 'ischemic outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",9326.0,0.0671022,"RM patients had significantly higher mean P2Y12 reaction units versus EM patients when treated with clopidogrel (39.93), but not with prasugrel (3.87).
","[{'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Doll', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Neely', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control and Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Winters', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Duvvuru', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Sundseth', 'Affiliation': 'Cabernet Pharmaceuticals, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Jakubowski', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland, United Kingdom. Electronic address: k.a.a.fox@ed.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2015.12.036']
862,32419647,Worry as a Mechanism to Motivate Information Seeking about Protective End-of-Life Communication Behaviors.,"Making known one's end-of-life (EOL) care wishes via the processes of advance care planning (ACP) and advance directive (AD) completion is associated with many positive outcomes for patients including lower healthcare costs, greater patient-provider relationship satisfaction, increased quality of life, and more. Despite these benefits, fewer than 30% of patients in the United States engage in ACP or complete ADs. These low numbers are most likely due to several causes, including low self-efficacy and low motivation to engage in the process. Several researchers have examined the persuasive power of using worry to motivate patients to engage in preventive health behaviors. The present study expands upon this body of literature by examining patient intentions to seek information related to ACP and AD after being exposed to stimuli intended to arouse differing levels of worry regarding bad EOL outcomes. Participants ( N  = 804) were randomly assigned to either the high worry, low worry, or control group and asked to complete a questionnaire examining beliefs and information seeking intentions regarding ACP and AD completion. Additionally, to control for participants' level of trait worry, each participant completed the Penn State Worry Questionnaire, which was treated as a covariate in the final analysis. A repeated measures MANCOVA found a statistically significant increase for the worrying conditions on the participants' intention to seek information about ACP and ADs from time 1 to time 2 for those in the worry experimental conditions. However, those in the control group did not show a statistically significant increase. Additionally, exposure to the high worry condition was predictive of engaging in actual information seeking behavior about EOL care. Results of the experiment indicate worry is associated with greater motivation to engage in information seeking about ACP and AD. This study contributes to the literature on worry as a persuasive mechanism to motivate patients to engage in important preventative health behaviors.",2020,A repeated measures MANCOVA found a statistically significant increase for the worrying conditions on the participants' intention to seek information about ACP and ADs from time 1 to time 2 for those in the worry experimental conditions.,['Participants ( N  =\xa0804'],"['high worry, low worry, or control group and asked to complete a questionnaire examining beliefs and information seeking intentions regarding ACP and AD completion']",['Penn State Worry Questionnaire'],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]","[{'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}]",804.0,0.0240796,A repeated measures MANCOVA found a statistically significant increase for the worrying conditions on the participants' intention to seek information about ACP and ADs from time 1 to time 2 for those in the worry experimental conditions.,"[{'ForeName': 'Christian R', 'Initials': 'CR', 'LastName': 'Seiter', 'Affiliation': 'Department of Communication, George Mason University , Fairfax, Virginia, USA.'}, {'ForeName': 'Nate S', 'Initials': 'NS', 'LastName': 'Brophy', 'Affiliation': 'Department of Communication, George Mason University , Fairfax, Virginia, USA.'}]",Journal of health communication,['10.1080/10810730.2020.1765222']
863,26811126,Drinkers' memory bias for alcohol picture cues in explicit and implicit memory tasks.,"BACKGROUND


Alcohol cues can bias attention and elicit emotional reactions, especially in drinkers. Yet, little is known about how alcohol cues affect explicit and implicit memory processes, and how memory for alcohol cues is affected by acute alcohol intoxication.
METHODS


Young adult participants (N=161) were randomly assigned to alcohol, placebo, or control beverage conditions. Following beverage consumption, they were shown neutral, emotional and alcohol-related pictures cues. Participants then completed free recall and repetition priming tasks to test explicit and implicit memory, respectively, for picture cues. Average blood alcohol concentration for the alcohol group was 74±13mg/dl when memory testing began. Two mixed linear model analyses were conducted to examine the effects of beverage condition, picture cue type, and their interaction on explicit and implicit memory.
RESULTS


Picture cue type and beverage condition each significantly affected explicit recall of picture cues, whereas only picture cue type significantly influenced repetition priming. Individuals in the alcohol condition recalled significantly fewer pictures than those in other conditions, regardless of cue type. Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues. No interaction effects were detected.
CONCLUSIONS


Young adult drinkers showed enhanced explicit and implicit memory processing of alcohol cues compared to emotionally neutral cues. This enhanced processing for alcohol cues was on par with that seen for positive emotional cues. Acute alcohol intoxication did not alter this preferential memory processing for alcohol cues over neutral cues.",2016,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"['Young adult drinkers', 'Young adult participants (N=161']","['alcohol, placebo, or control beverage conditions']","['enhanced explicit and implicit memory processing of alcohol cues', 'explicit recall of picture cues', 'Average blood alcohol concentration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0561768', 'cui_str': 'Implicit memory (observable entity)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",161.0,0.0200569,Both free recall and repetition priming were greater for emotional and alcohol-related cues compared to neutral picture cues.,"[{'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: ttn045@ucsd.edu.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: jbuckman@rutgers.edu.'}, {'ForeName': 'Suchismita', 'Initials': 'S', 'LastName': 'Ray', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: shmita@rci.rutgers.edu.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, 607 Allison Road, Rutgers University, Piscataway, NJ 08854, United States. Electronic address: mebates@rutgers.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2015.12.033']
864,32019981,Comparisons between end-effector and exoskeleton rehabilitation robots regarding upper extremity function among chronic stroke patients with moderate-to-severe upper limb impairment.,"End-effector (EE) and exoskeleton (Exo) robots have not been directly compared previously. The present study aimed to directly compare EE and Exo robots in chronic stroke patients with moderate-to-severe upper limb impairment. This single-blinded, randomised controlled trial included 38 patients with stroke who were admitted to the rehabilitation hospital. The patients were equally divided into EE and Exo groups. Baseline characteristics, including sex, age, stroke type, brain lesion side (left/right), stroke duration, Fugl-Meyer Assessment (FMA)-Upper Extremity score, and Wolf Motor Function Test (WMFT) score, were assessed. Additionally, impairment level (FMA, motor status score), activity (WMFT), and participation (stroke impact scale [SIS]) were evaluated. There were no significant differences in baseline characteristics between the groups. After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation). There was no intervention-related adverse event. The EE robot intervention is better than the Exo robot intervention with regard to activity and participation among chronic stroke patients with moderate-to-severe upper limb impairment. Further research is needed to confirm this novel finding.",2020,"After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation).","['chronic stroke patients with moderate-to-severe upper limb impairment', '38 patients with stroke who were admitted to the rehabilitation hospital']","['exoskeleton rehabilitation robots', 'EE and Exo robots', 'End-effector (EE) and exoskeleton (Exo) robots']","['impairment level (FMA, motor status score), activity (WMFT), and participation (stroke impact scale [SIS', 'activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation', 'sex, age, stroke type, brain lesion side (left/right), stroke duration, Fugl-Meyer Assessment (FMA)-Upper Extremity score, and Wolf Motor Function Test (WMFT) score']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}]","[{'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain (finding)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",38.0,0.020525,"After the intervention, improvements were significantly better in the EE group with regard to activity and participation (WMFT-Functional ability rating scale, WMFT-Time, and SIS-Participation).","[{'ForeName': 'Stephanie Hyeyoung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Gyulee', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Duk Youn', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Yeong', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea.'}, {'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Law, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Si-Bog', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, Ministry of Health and Welfare, Seoul, Republic of Korea. asfreelyas@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-58630-2']
865,32419128,Resuscitation of the patient with suspected/confirmed COVID-19 when wearing personal protective equipment: A randomized multicenter crossover simulation trial.,"BACKGROUND


The aim of the study was to evaluate various methods of chest compressions in patients with suspected/confirmed SARS-CoV-2 infection conducted by medical students wearing full personal protective equipment (PPE) for aerosol generating procedures (AGP).
METHODS


This was prospective, randomized, multicenter, single-blinded, crossover simulation trial. Thirty-five medical students after an advanced cardiovascular life support course, which included performing 2-min continuous chest compression scenarios using three methods: (A) manual chest compression (CC), (B) compression with CPRMeter, (C) compression with LifeLine ARM device. During resuscitation they are wearing full personal protective equipment for aerosol generating procedures.
RESULTS


The median chest compression depth using manual CC, CPRMeter and LifeLine ARM varied and amounted to 40 (38-45) vs. 45 (40-50) vs. 51 (50-52) mm, respectively (p = 0.002). The median chest compression rate was 109 (IQR; 102-131) compressions per minute (CPM) for manual CC, 107 (105-127) CPM for CPRMeter, and 102 (101-102) CPM for LifeLine ARM (p = 0.027). The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
CONCLUSIONS


According to the results of this simulation trial, automated chest compression devices (ACCD) should be used for chest compression of patients with suspected/confirmed COVID-19. In the absence of ACCD, it seems reasonable to change the cardiopulmonary resuscitation algorithm (in the context of patients with suspected/confirmed COVID-19) by reducing the duration of the cardiopulmonary resuscitation cycle from the current 2-min to 1-min cycles due to a statistically significant reduction in the quality of chest compressions among rescuers wearing PPE AGP.",2020,"The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
","['patients with suspected/confirmed SARS-CoV-2 infection conducted by medical students wearing full personal protective equipment (PPE) for aerosol generating procedures (AGP', 'Thirty-five medical students after an advanced cardiovascular life support course, which included performing']","['automated chest compression devices (ACCD', '2-min continuous chest compression scenarios using 3 methods: (A) manual chest compression (CC), (B) compression with CPRMeter, (C) compression with LifeLine ARM device']","['percentage of correct chest recoil', 'median chest compression depth', 'median chest compression rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",35.0,0.0730583,"The percentage of correct chest recoil was the highest for LifeLine ARM - 100% (95-100), 80% (60-90) in CPRMeter group, and the lowest for manual CC - 29% (26-48).
","[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Malysz', 'Affiliation': 'Polish Society of Disaster Medicine, Warsaw, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Dabrowski', 'Affiliation': 'Chair and Department of Medical Education, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Bernd W', 'Initials': 'BW', 'LastName': 'Böttiger', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Cologne, Köln, Germany.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': 'Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Kulak', 'Affiliation': 'Lazarski University, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szarpak', 'Affiliation': 'Maria Skłodowska-Curie Warsaw University, Warsaw, Poland.'}, {'ForeName': 'Milosz', 'Initials': 'M', 'LastName': 'Jaguszewski', 'Affiliation': 'First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': 'First Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Jerzy R', 'Initials': 'JR', 'LastName': 'Ladny', 'Affiliation': 'Clinic of Emergency Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Departments of General Anesthesiology and Outcomes Research, Cleveland Clinic, Anesthesiology Institute, Cleveland, OH, USA.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Szarpak', 'Affiliation': 'Lazarski University, Warsaw, Poland. lukasz.szarpak@gmail.com.'}]",Cardiology journal,['10.5603/CJ.a2020.0068']
866,26686755,Cetuximab activity in dysplastic lesions of the upper aerodigestive tract.,"BACKGROUND


High risk head and neck mucosal premalignancy has a malignant conversion rate of up to 40%, despite adequate surgical therapy. Epidermal Growth Factor Receptor (EGFR) blocking agents, including cetuximab, have shown activity in head and neck squamous cell carcinoma (HNSCC) and have potential for therapy in high risk premalignancy.
METHODS


We conducted a randomized, prospective, phase II clinical trial to determine the effects of cetuximab on patients with high risk premalignancy. Patients were randomized to treatment with cetuximab 400mg/m(2) on week one followed by 250mg/m(2) on week 2-8 or observation, with the option for crossover to cetuximab therapy for patients originally randomized to the observation arm.
RESULTS


Two of 19 enrolled patients did not complete therapy due to treatment toxicity. Analysis of 17 patients who completed the trial regimen show a trend toward a larger mean decrease in grade of dysplasia in the cetuximab treated group (-1.0) vs. the observation group (-0.2) (P=0.082, one-sided exact Wilcoxon rank sum test). However, in the observation group, none of the 5 patients (0%) achieved complete resolution of dysplasia; while 4 of 12 (33.3%) cetuximab treated patients had no remaining dysplasia after therapy.
CONCLUSIONS


Treatment of high risk premalignancy of the upper aerodigestive tract with cetuximab alone may result in significant, durable, and complete clinical and histological resolution of moderate to severe dysplasia in at least a subset of high risk patients. These results warrant further investigation in larger studies with increased statistical power.",2016,"Analysis of 17 patients who completed the trial regimen show a trend toward a larger mean decrease in grade of dysplasia in the cetuximab treated group (-1.0) vs. the observation group (-0.2) (P=0.082, one-sided exact Wilcoxon rank sum test).","['head and neck squamous cell carcinoma (HNSCC', 'dysplastic lesions of the upper aerodigestive tract', 'patients with high risk premalignancy']","['cetuximab', 'cetuximab 400mg/m(2) on week one followed by 250mg/m(2) on week 2-8 or observation, with the option for crossover to cetuximab therapy']","['complete resolution of dysplasia', 'treatment toxicity', 'grade of dysplasia']","[{'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1267213', 'cui_str': 'Upper aerodigestive tract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.024387,"Analysis of 17 patients who completed the trial regimen show a trend toward a larger mean decrease in grade of dysplasia in the cetuximab treated group (-1.0) vs. the observation group (-0.2) (P=0.082, one-sided exact Wilcoxon rank sum test).","[{'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Joel B', 'Initials': 'JB', 'LastName': 'Epstein', 'Affiliation': 'University of Illinois Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Marur', 'Affiliation': 'Oncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'M Boyd', 'Initials': 'MB', 'LastName': 'Gillespie', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Feldman', 'Affiliation': 'University of Illinois Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Hua-Ling', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sciubba', 'Affiliation': 'Milton J Dance Head and Neck Center, Greater Baltimore Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburg Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Grandis', 'Affiliation': 'University of Pittsburg Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gibson', 'Affiliation': 'University of Pittsburg Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Koch', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tufano', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Westra', 'Affiliation': 'Oncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Tsottles', 'Affiliation': 'Oncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ozawa', 'Affiliation': 'Oncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Oncology Department, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Califano', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA; Milton J Dance Head and Neck Center, Greater Baltimore Medical Center, Baltimore, MD, USA. Electronic address: jcalifano@ucsd.edu.'}]",Oral oncology,['10.1016/j.oraloncology.2015.11.016']
867,32418845,Association between Patient-Reported Outcomes and Time to Late Age-Related Macular Degeneration in the Laser Intervention in Early Stages of Age-Related Macular Degeneration Study.,"PURPOSE


To investigate the relationship between patient-reported outcome (PRO) questionnaire responses and time to late age-related macular degeneration (AMD; neovascular AMD [nAMD] or multimodal imaging [MMI]-defined atrophy) among individuals with bilateral large drusen, and the prognostic value of baseline PROs for 36-month AMD status.
DESIGN


Exploratory analyses from a multicenter randomized controlled trial of an AMD intervention (Australian New Zealand Clinical Trials Registry identifier, ACTRN12612000704897).
PARTICIPANTS


Sham treatment group of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n = 141; age, 50-88 years; 77% female).
METHODS


The 28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10) were administered at the baseline visit. The PRO scores were derived using rating scale models. Multivariate Cox regression adjusting for demographics and clinical measures of vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity) from the poorer-performing eye was used to investigate the association between PRO scores and time to late AMD in either eye. Multivariate competing-risk regression was used to estimate cause-specific subhazard ratios for nAMD and atrophy in either eye. Cross-validated logistic lasso models were used to estimate the predicted probability of AMD at 36 months. The area under the receiver operating characteristic curve was assessed to compare prognostic accuracy between models with and without PROs.
MAIN OUTCOME MEASURE


Time until nAMD or atrophy in either eye.
RESULTS


The PRO scores were skewed toward higher functional vision. Higher IVI-28 scores were associated with a lower risk of progression to MMI-defined atrophy (20 events: adjusted hazard ratio, 0.65/logit increase; P = 0.002) but not nAMD (10 events; P = 0.562). Insufficient evidence was found of an association between NVQ-10 score and rate of progression to late AMD (P ≥0.149). Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
CONCLUSIONS


On average, PROs were associated with an increased risk of progression from intermediate AMD to MMI-defined atrophy. Continuing development of instruments to record PROs in the early stages of AMD have the potential to produce inexpensive and efficient tools to assist in the assessment of disease severity and risk of AMD progression.",2020,"Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
","['individuals with bilateral large drusen', 'in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n\xa0= 141; age, 50-88 years; 77% female']","['multimodal imaging [MMI]-defined atrophy', 'Laser Intervention', 'AMD intervention']","['NVQ-10 score and rate of progression to late AMD', 'PRO scores and time to late AMD', 'Higher IVI-28 scores', '28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10', 'PRO scores', 'Time until nAMD or atrophy in either eye', 'Baseline IVI-28 scores', 'vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1513743', 'cui_str': 'Imaging, Multimodal'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0234684', 'cui_str': 'Luminance'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",141.0,0.0309192,"Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
","[{'ForeName': 'Myra B', 'Initials': 'MB', 'LastName': 'McGuinness', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Centre for Biostatistics and Epidemiology, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: myra.mcguinness@unimelb.edu.au.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Finger', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Luu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Fred K', 'Initials': 'FK', 'LastName': 'Chen', 'Affiliation': 'Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), The University of Western Australia, Crawley, Australia, Department of Ophthalmology, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Jenifer J', 'Initials': 'JJ', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Research, Sydney, Australia.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, United Kingdom.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.03.015']
868,26614647,Immediate and Complex Cardiovascular Adaptation to an Acute Alcohol Dose.,"BACKGROUND


The detrimental effects of chronic heavy alcohol use on the cardiovascular system are well established and broadly appreciated. Integrated cardiovascular response to an acute dose of alcohol has been less studied. This study examined the early effects of an acute dose of alcohol on the cardiovascular system, with particular emphasis on system variability and sensitivity. The goal was to begin to understand how acute alcohol disrupts dynamic cardiovascular regulatory processes prior to the development of cardiovascular disease.
METHODS


Healthy participants (N = 72, age 21 to 29) were randomly assigned to an alcohol, placebo, or no-alcohol control beverage condition. Beat-to-beat heart rate (HR) and blood pressure (BP) were assessed during a low-demand cognitive task prior to and following beverage consumption. Between-group differences in neurocardiac response to an alcohol challenge (blood alcohol concentration ~ 0.06 mg/dl) were tested.
RESULTS


The alcohol beverage group showed higher average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity after alcohol consumption. No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content. At the level of the individual, an active alcohol dose appeared to disrupt the typically tight coupling between cardiovascular processes.
CONCLUSIONS


A dose of alcohol quickly invoked multiple cardiovascular responses, possibly as an adaptive reaction to the acute pharmacological challenge. Future studies should assess how exposure to alcohol acutely disrupts or dissociates typically integrated neurocardiac functions.",2015,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","['Healthy participants (N\xa0=\xa072, age 21 to 29']","['alcohol', 'placebo', 'alcohol, placebo, or no-alcohol control beverage condition']","['average HR, lower average stroke volume, lower HR variability and BP variability, and increased vascular tone baroreflex sensitivity', 'average HR and BP', 'Beat-to-beat heart rate (HR) and blood pressure (BP', 'neurocardiac response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0345724,"No changes were observed in the placebo group, but the control group showed slightly elevated average HR and BP after beverage consumption, possibly due to juice content.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Center of Alcohol Studies, Rutgers, The State University of New Jersey, Piscataway, New Jersey.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.12912']
869,31498380,Effect of Immersive Virtual Reality Education Before Chest Radiography on Anxiety and Distress Among Pediatric Patients: A Randomized Clinical Trial.,"Importance


Pediatric patients often encounter anxiety and distress in hospital settings, and virtual reality education, providing a vivid, immersive, and realistic experience, has been introduced to mitigate these anxiety responses.
Objective


To evaluate whether virtual reality education for pediatric patients before chest radiography could reduce anxiety and distress in children and improve the radiographic process.
Design, Setting, and Participants


This prospective randomized clinical trial was conducted in a tertiary academic hospital in Seongnam, Republic of Korea. Participants (n = 112) were children aged 4 to 8 years who underwent chest radiography between July 20, 2018, and September 11, 2018. Analysis was performed from October 2, 2018, to April 23, 2019.
Interventions


Children were randomized to simple verbal instruction (control group) or 3-minute virtual reality education explaining the process of chest radiography in detail and leading to appropriate cooperation (virtual reality group).
Main Outcomes and Measures


The primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed). Secondary outcomes were the need of parental presence, parental satisfaction score, procedure time, number of repeated images, and process difficulty score.
Results


Of 99 children included in the final analysis, 50 (50.5%) were allocated to the control group (mean [SD] age, 5.6 [1.2] years; 26 boys [52.0%]) and 49 (49.5%) to the virtual reality group (mean [SD] age, 5.8 [1.3] years; 32 boys [65.3%]). The mean (SD) score for anxiety and distress (2.0 [3.7] vs 5.0 [6.1]; mean difference, 3.0 [95% CI, 1.0-5.0]; P = .004), need for parental presence (8 cases with parents present [16.3%] vs 18 cases with parents present [36.0%]), and mean (SD) procedure time (55.1 [21.6] seconds vs 75.0 [42.0] seconds) were lower in the virtual reality group than in the control group. The mean (SD) score for parental satisfaction (9.4 [1.4] vs 8.6 [2.0]) was higher in the virtual reality group than in the control group.
Conclusions and Relevance


Virtual reality education before chest radiography improved the radiography experience among pediatric patients by reducing anxiety, distress, and procedure time while increasing parents' satisfaction.
Trial Registration


UMIN Clinical Trials Registry: UMIN000030663.",2019,"The primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed).","['Interventions\n\n\nChildren', 'Pediatric Patients', '99 children included in the final analysis, 50 (50.5%) were allocated to the control group (mean [SD] age, 5.6 [1.2] years; 26 boys [52.0%]) and 49 (49.5%) to the virtual reality group (mean [SD] age, 5.8 [1.3] years; 32 boys [65.3', 'pediatric patients', 'pediatric patients before chest', 'Participants (n\u2009', 'tertiary academic hospital in Seongnam, Republic of Korea', '112) were children aged 4 to 8 years who underwent chest radiography between July 20, 2018, and September 11, 2018']","['simple verbal instruction (control group) or 3-minute virtual reality education explaining the process of chest radiography in detail and leading to appropriate cooperation (virtual reality group', 'Immersive Virtual Reality Education Before Chest Radiography', 'virtual reality education', 'radiography']","['mean (SD) procedure time', 'mean (SD) score for parental satisfaction', 'behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed', 'anxiety and distress', 'Anxiety and Distress', 'need of parental presence, parental satisfaction score, procedure time, number of repeated images, and process difficulty score', 'mean (SD) score for anxiety and distress']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558039', 'cui_str': 'Behavior Observation'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0222045'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",99.0,0.0928754,"The primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed).","[{'ForeName': 'Sung-Hee', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Gwanak-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Gwanak-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Il', 'Initials': 'SI', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyunju', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Hee-Jeong', 'Initials': 'HJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Psychiatry, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Gwanak-gu, Seoul, Republic of Korea.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.3000']
870,32418846,Orally Administered Alpha Lipoic Acid as a Treatment for Geographic Atrophy: A Randomized Clinical Trial.,"PURPOSE


Alpha lipoic acid (ALA) is a nutraceutical and potent antioxidant that has shown efficacy in the retina light damage mouse model and in humans for multiple sclerosis. Our objective was to evaluate the efficacy and safety of oral ALA for the treatment of geographic atrophy (GA).
DESIGN


Randomized, controlled, double-masked, multicenter phase 2 clinical trial of ALA versus placebo.
PARTICIPANTS


Participants with unilateral or bilateral GA from age-related macular degeneration.
METHODS


Participants were randomized to 1200 mg daily of ALA or placebo. Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA) was obtained at baseline and every 6 months through month 18.
MAIN OUTCOME MEASURES


Annual rate of change over 18 months in square root-transformed area of GA in study eyes as measured on fundus autofluorescence. Secondary outcomes included the number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs.
RESULTS


Fifty-three participants (mean age, 80 years) were randomized (April 2016-August 2017). Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group. Unadjusted mean (standard error) annual change in GA area was 0.28 (0.02) mm and 0.31 (0.02) mm for the placebo and ALA groups, respectively (difference, 0.04 mm; 95% confidence interval [CI], -0.03 to 0.11 mm; P = 0.30). Adjusting for baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area was 0.27 (0.04) mm and 0.32 (0.05) mm for the placebo and ALA groups, respectively (difference, 0.05 mm; 95% CI, -0.02 to 0.12 mm; P = 0.14). At 18 months, the percent of eyes losing 15 letters or more of BCVA was 22% (8 of 36) and 14% (5 of 36) in the placebo and ALA groups, respectively (P = 0.54). No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
CONCLUSIONS


Results do not support ALA having beneficial effects on GA or BCVA. This trial design may be useful for other GA repurposing drug trials.",2020,"No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
","['Participants with unilateral or bilateral GA from age-related macular degeneration', 'Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group', 'Fifty-three participants (mean age, 80 years', 'Participants', 'Geographic Atrophy']","['Alpha lipoic acid (ALA', 'ALA or placebo', 'oral ALA', 'Alpha Lipoic Acid', 'ALA versus placebo', 'placebo']","['number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs', 'Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA', 'percent of eyes losing 15 letters or more of BCVA', 'efficacy and safety', 'Unadjusted mean (standard error) annual change in GA area', 'baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]",,0.764548,"No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: Benjamin.Kim@uphs.upenn.edu.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'Oregon Eye Consultants, Eugene, Oregon.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Brucker', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hahn', 'Affiliation': 'New Jersey Retina, Teaneck, New Jersey.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gehrs', 'Affiliation': 'Department of Ophthalmology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Retina Northwest, Portland, Oregon.'}, {'ForeName': 'Albert O', 'Initials': 'AO', 'LastName': 'Edwards', 'Affiliation': 'Oregon Retina, Eugene, Oregon.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Nissim', 'Affiliation': ""Division of Genetics and Metabolic Disease, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Pediatrics, Biochemistry and Biophysics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Grunwald', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Pistilli', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Dunaief', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.03.019']
871,32419281,Effects of soy isoflavones on serum systemic and vascular inflammation markers and oxidative stress in peritoneal dialysis patients: A randomized controlled trial.,"Cardiovascular disease (CVD) is common in peritoneal dialysis (PD) patients. This study was designed to investigate the effects of isoflavones on systemic and vascular inflammation markers and oxidative stress in PD patients. In this randomized clinical trial, 40 PD patients were randomly assigned to either the isoflavone or the placebo group. The isoflavone group received 100 mg soy isoflavones daily for 8 weeks, whereas the placebo group received corresponding placebos. At baseline and the end of eighth week, serum high sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule type 1 (ICAM-1), vascular cell adhesion molecule type 1 (VCAM-1), E-selectin, and malondialdehyde were measured. Serum VCAM-1 decreased significantly in the isoflavone group at the end of Week 8 compared to baseline (p = .01), whereas no significant change was observed in the placebo group. Serum ICAM-1 decreased significantly in the isoflavone (p = .01) and placebo (p = .01) group compared to baseline. However, the reduction of ICAM-1 was significantly higher in the isoflavone group than in the placebo group (p = .02). There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP. This study indicates that isoflavones reduce serum VCAM-1 and ICAM-1, which are two CVD risk factors, in PD patients.",2020,"There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP.","['peritoneal dialysis (PD) patients', 'PD patients', 'peritoneal dialysis patients', '40 PD patients']","['100\u2009mg soy isoflavones', 'isoflavones', 'placebos', 'isoflavone', 'soy isoflavones', 'placebo']","['mean changes of serum E-selectin, malondialdehyde, and hs-CRP', 'Serum VCAM-1', 'serum systemic and vascular inflammation markers and oxidative stress', 'reduction of ICAM-1', 'systemic and vascular inflammation markers and oxidative stress', 'serum high sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule type 1 (ICAM-1), vascular cell adhesion molecule type 1 (VCAM-1), E-selectin, and malondialdehyde', 'Cardiovascular disease (CVD', 'Serum ICAM-1']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",40.0,0.413522,"There were no significant differences between the two groups in mean changes of serum E-selectin, malondialdehyde, and hs-CRP.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Tabibi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Najafi', 'Affiliation': 'Department of Nephrology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular and Molecular Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Movahedian', 'Affiliation': 'National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6729']
872,31556212,Application of ICD-11 among individuals with chronic pain: A post hoc analysis of the Stanford Self-Management Program.,"BACKGROUND


Chronic primary pain (CPP) is one of seven diagnostic groups within the proposed classification of chronic pain in ICD-11. Our aims were to apply the proposed ICD-11 criteria in a large cohort of chronic pain patients participating in the Chronic Pain Self-Management Program (CPSMP) and further investigate whether participants with CPP differed from participants with chronic secondary pain (CSP) regarding health, health expenditure and the effect of participating in the CPSMP.
METHODS


A secondary analysis of a randomized, controlled trial on the effect of the CPSMP. Four examiners categorized participants' pain according to ICD-11 using register-based medical diagnoses and patients' self-reported symptoms. Afterwards, differences between CPP and CSP were examined.
RESULTS


Out of 394 participants, 312 were successfully classified into CPP (n = 164) or CSP (n = 148) whereas 76 had a mixed pain condition. Participants with CPP were younger, more likely to be women, and had longer pain duration compared to participants with CSP. Participants with CPP reported worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain. Participants with CSP had more physical comorbidities and higher total health expenditure. None of the groups benefitted from the CPSMP.
CONCLUSIONS


We successfully applied the new classification of chronic pain in ICD-11 on the basis of ICD-10 medical diagnoses and symptom self-report. Participants with CPP differed significantly from participants with CSP on baseline characteristics, self-reported health measures and total health expenditure. The CPSMP was not effective in any of the groups.
SIGNIFICANCE


The current study applies the proposed new classification of chronic pain in ICD-11 and shares the experiences of the diagnostic rating procedure of individuals with chronic pain. Furthermore, it evaluates the effect of the Stanford Self-Management Program.",2020,"Participants with CPP reported worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain.","['individuals with chronic pain', 'Chronic primary pain (CPP', 'chronic pain patients participating in the Chronic Pain Self-Management Program (CPSMP) and further investigate whether participants with CPP differed from participants with chronic secondary pain (CSP) regarding health, health expenditure and the effect of participating in the CPSMP', '394 participants, 312 were successfully classified into CPP (n\xa0=\xa0164) or CSP (n\xa0=\xa0148) whereas 76 had a mixed pain condition']","['ICD-11', 'CPSMP']","['worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain', 'baseline characteristics, self-reported health measures and total health expenditure', 'longer pain duration', 'physical comorbidities and higher total health expenditure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015318', 'cui_str': 'Health Expenditures'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4704940', 'cui_str': 'ICD-11'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015318', 'cui_str': 'Health Expenditures'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",394.0,0.097158,"Participants with CPP reported worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Hornemann', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schröder', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ørnbøl', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Nils Balle', 'Initials': 'NB', 'LastName': 'Christensen', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Marian Dalgaard', 'Initials': 'MD', 'LastName': 'Høeg', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Mehlsen', 'Affiliation': 'The Department of Psychology and Behavioural Science, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Frostholm', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1486']
873,31549922,"""Train-High Sleep-Low"" Dietary Periodization Does Not Alter Ventilatory Strategies During Cycling Exercise.","Objective:  The purpose of this study was to investigate the effects of ""train-high sleep-low"" (THSL) dietary periodization on ventilatory strategies during cycling exercise at submaximal and maximal intensities. Method:  In a randomized crossover design, 8 trained men [age (mean ± SEM) = 28 ± 1 y; peak oxygen uptake = 56.8 ± 2.4 mL kg -1  min -1 ] completed two glycogen-depleting protocols on a cycle ergometer on separate days, with the cycling followed by a low carbohydrate (CHO) meal and beverages containing either no additional CHO (THSL) or beverages containing 1.2 g kg -1  CHO [traditional CHO replacement (TRAD)]. The following morning, participants completed 4 minutes of cycling below (Stage 1), at (Stage 2), and above (Stage 3) gas exchange threshold, followed by a 5-km time trial. Results:  Timetrial performance was significantly faster in TRAD compared to THSL (8.7 ± 0.3 minutes and 9.0 ± 0.3 minutes, respectively;  p  = 0.02). No differences in ventilation, tidal volume, or carbon dioxide production occurred between conditions at any exercise intensity ( p  > 0.05). During Stage 1, oxygen uptake was 37.9 ± 1.5 mL kg -1  min -1  in the TRAD condition and 39.6 ± 1.8 mL kg -1  min -1  in THSL ( p  = 0.05). During Stage 2, VO2 was 44.6 ± 1.7 mL kg -1  min -1  in the TRAD condition and 47.0 ± 1.9 mL kg -1  min -1  in THSL ( p  = 0.07). No change in operating lung volume was detected between dietary conditions ( p  > 0.05). Conclusions:  THSL impairs performance following the dietary intervention, but this occurs with no alteration of ventilatory measures.",2020,"No differences in ventilation, tidal volume, or carbon dioxide production occurred between conditions at any exercise intensity ( p  > 0.05).",['8 trained men [age (mean\u2009±\u2009SEM) = 28\u2009±\u20091 y; peak oxygen uptake = 56.8\u2009±\u20092.4\u2009mL kg -1  min -1 ] completed two'],"['Train-High Sleep-Low"" Dietary Periodization', 'train-high sleep-low"" (THSL) dietary periodization', 'THSL', 'glycogen-depleting protocols on a cycle ergometer on separate days, with the cycling followed by a low carbohydrate (CHO) meal and beverages containing either no additional CHO (THSL) or beverages containing 1.2\u2009g kg -1  CHO [traditional CHO replacement (TRAD']","['Timetrial performance', 'ventilation, tidal volume, or carbon dioxide production', 'operating lung volume']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0033268'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}]",,0.0994338,"No differences in ventilation, tidal volume, or carbon dioxide production occurred between conditions at any exercise intensity ( p  > 0.05).","[{'ForeName': 'Hunter L', 'Initials': 'HL', 'LastName': 'Paris', 'Affiliation': 'Department of Kinesiology, School of Public Health-Bloomington, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Fulton', 'Affiliation': 'Department of Kinesiology, School of Public Health-Bloomington, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Wilhite', 'Affiliation': 'Department of Kinesiology, School of Public Health-Bloomington, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Marissa N', 'Initials': 'MN', 'LastName': 'Baranauskas', 'Affiliation': 'Department of Kinesiology, School of Public Health-Bloomington, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Chapman', 'Affiliation': 'Department of Kinesiology, School of Public Health-Bloomington, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mickleborough', 'Affiliation': 'Department of Kinesiology, School of Public Health-Bloomington, Indiana University, Bloomington, Indiana, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1654419']
874,29313415,A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD.,"Objective:  To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD.  Method:  In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs.  Results:  Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p  value = .0392), ADHD-RS-IV ( p  < .0001), CGI-S ( p  = .0007), and CGI-I ( p  = .003). There were no serious adverse events and no new safety signals.  Conclusion:  Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.",2020,"RESULTS


Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003).","['children aged 6 to 12 years diagnosed with ADHD', 'children with ADHD']","['guanfacine extended-release (GXR) versus placebo', 'GXR', 'placebo', 'Guanfacine']","['Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales', 'Executive Function and ADHD', 'BRIEF-P', 'adverse events and vital signs', 'serious adverse events', 'executive function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}]",,0.132221,"RESULTS


Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003).","[{'ForeName': 'Judy P M', 'Initials': 'JPM', 'LastName': 'van Stralen', 'Affiliation': 'Center for Pediatric Excellence, Ottawa, Ontario, Canada.'}]",Journal of attention disorders,['10.1177/1087054717751197']
875,32417564,Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials.,"PURPOSE


To determine the limitations of randomized sham surgery-controlled trials in orthopaedic sports medicine and fidelity of the trials' conclusions.
METHODS


Randomized placebo surgery-controlled trials in orthopaedic sports medicine were included in this Preferred Reporting Items for Systematic Reviews and Meta-Analyses-guided systematic review. Several aspects of investigation design and conduct were analyzed: genetic analysis for propensity to placebo response, equipoise of informed consent process, geography of trial subjects, percentage of eligible subjects willing to be randomized, changes from protocol publication to results publication, and perioperative complications.
RESULTS


Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; 5 from Europe, 1 from North America, and 1 from Australia; all superiority model, efficacy design) were analyzed. There were consistent methodologic deficiencies across studies. No studies reported genetic analysis of susceptibility to placebo response. Three studies (43%) were underpowered. Crossover rates ranged from 8% to 36%, which led to un-blinding in up to 100% of subjects. There were low enrollment rates of eligible subjects (up to 57% refused randomization). Follow-up was short term (2 years or less in all but one study). Complication rates ranged from 0% to 12.5%, with complications occurring in both groups (no significant difference between groups in any study).
CONCLUSIONS


Randomized sham-controlled studies in orthopaedic sports medicine have significant methodologic deficiencies that may invalidate their conclusions. Randomized trial design (with or without placebo control) may be optimized through the inclusion of per-protocol analysis, blinding index, equivalence or noninferiority trial design, and a nontreatment group.
LEVEL OF EVIDENCE


Level II Systematic Review of Level II studies.",2020,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","['orthopedic sports medicine', 'Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia', 'Orthopedic Surgery']","['Placebo', 'placebo']",['Complication rates'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",845.0,0.715691,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study).
","[{'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina, U.S.A.'}, {'ForeName': 'Benedict U', 'Initials': 'BU', 'LastName': 'Nwachukwu', 'Affiliation': 'Hospital for Special Surgery, New York, New York, U.S.A.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Nho', 'Affiliation': 'Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'UConn Musculoskeletal Institute at UConn Health, Farmington, Connecticut, U.S.A.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.. Electronic address: joshuaharrismd@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.001']
876,32418078,"Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.","BACKGROUND


Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients.
OBJECTIVE


This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI.
METHODS


In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety.
RESULTS


Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events.
CONCLUSIONS


Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI.
TRIAL REGISTRATION


Trial number: NCT03192618.",2020,"OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively).","['Between June 2016 and April 2019', 'Hepatocellular Carcinoma Patients with Microvascular Invasion', 'hepatocellular carcinoma (HCC) patients', 'HCC patients with histologically confirmed MVI', 'HCC patients with MVI', '127 patients']","['adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group', 'FU', 'postoperative adjuvant transarterial infusion chemotherapy (TAI', 'FOLFOX']","['OS and DFS', 'OS rates', 'severe adverse events', 'survival benefits', 'efficacy and safety', 'DFS rates', 'overall survival (OS) and safety', 'disease-free survival (DFS']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",127.0,0.100369,"OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively).","[{'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Qiaoxuan', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhixing', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lianghe', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Minshan', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Rongping', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. guorp@sysucc.org.cn.""}]",Annals of surgical oncology,['10.1245/s10434-020-08601-8']
877,32424462,Comparison of the effects of injectable platelet-rich fibrin and autologous fibrin glue applications on palatal wound healing: a randomized controlled clinical trial.,"OBJECTIVE


The aim of this study was to compare the effects of AFG and i-PRF on palatal wound healing and postoperative discomfort.
MATERIALS AND METHODS


Thirty-six patients in need of FGG were divided into three groups. AFG (n = 12) or i-PRF (n = 12) was applied and compared with control group (n = 12). Wound healing with H 2 O 2  test, VAS, MSS, and LTH index were evaluated on the 3rd,7th, and 14th days and 1st month. The bleeding status was evaluated on the 3rd and 7th days. Palatal tissue thickness was measured at baseline, 1st month, and 3rd month.
RESULTS


Epithelialization was higher in the test groups on the 14th day than the control group (p < 0.05). MSS scores at the 14th day and 1st month were lower in the AFG group than the control and the i-PRF group (p < 0.05). In the AFG group, LTH levels at the 3rd,7th, and 14th days and 1 month were higher than control and i-PRF groups (p < 0.05). VAS scores of the AFG group were lower than the control and i-PRF groups at the 7th day (p < 0.05). Bleeding was lower in the test groups than in the control group (p < 0.05). There was no difference between the groups in terms of tissue thickness (p > 0.05).
CONCLUSION


AFG and i-PRF have positive effects on the healing process by accelerating wound healing and reducing postoperative morbidity. Therewithal, AFG has superior properties in wound healing compared with i-PRF.
CLINICAL RELEVANCE


Patient discomfort and pain feeling have a great effect on patient's tendency to surgery and platelet concentrates such as AFG and i-PRF overcome these problems and contribute to patient's quality of life.",2020,VAS scores of the AFG group were lower than the control and i-PRF groups at the 7th day (p < 0.05).,"['Thirty-six patients in need of FGG', 'palatal wound healing']","['AFG', 'injectable platelet-rich fibrin and autologous fibrin glue applications', 'AFG and i-PRF']","['bleeding status', 'LTH levels', 'Wound healing with H 2 O 2  test, VAS, MSS, and LTH index', 'Bleeding', 'MSS scores', 'tissue thickness', 'postoperative morbidity', 'VAS scores', 'Palatal tissue thickness', 'Epithelialization']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024814', 'cui_str': 'Marinesco-Sjögren syndrome'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}]",36.0,0.0208954,VAS scores of the AFG group were lower than the control and i-PRF groups at the 7th day (p < 0.05).,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kızıltoprak', 'Affiliation': 'Batman Oral and Dental Health Center, Batman, Turkey.'}, {'ForeName': 'Mustafa Özay', 'Initials': 'MÖ', 'LastName': 'Uslu', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Inonu University, 44280, Malatya, Turkey. mustafaozayuslu@hotmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03320-6']
878,32424502,Is there an association between perceived social support and cardiovascular health behaviours in people with severe mental illnesses?,"PURPOSE


People with severe mental illnesses (SMI) have an increased risk of cardiovascular disease (CVD). Research in the general population suggests that social support may protect against increased CVD morbidity and mortality; however, this may not apply to those with SMI. We aimed to explore the association between perceived social support and attendance at primary care nurse CVD risk reduction clinic appointments and CVD risk-reducing behaviours in an SMI population with elevated CVD risk factors.
METHODS


We used longitudinal and cross-sectional data from a randomised controlled trial on 326 adults with SMI recruited via 76 general practices in England. Multilevel regression analysis estimated the effect of perceived social support on attendance at CVD risk reduction clinic appointments over 6 months, and adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment.
RESULTS


Perceived social support predicted greater appointment attendance in unadjusted (IRR = 1.005; 1.000-1.010; p = 0.05) but not adjusted analysis (IRR = 1.003; 0.998-1.009; p = 0.25). Perceived social support was associated with greater adherence to medication; for each 1% increase in social support, there was a 4.2% increase in medication adherence (OR = 1.042; 1.015-1.070; p = 0.002). No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.",2020,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","['SMI population with elevated CVD risk factors', '326 adults with SMI recruited via 76 general practices in England', 'People with severe mental illnesses (SMI', 'people with severe mental illnesses']",[],"['CVD morbidity and mortality', 'appointment attendance', 'adherence to CVD medication, physical activity, diet, smoking and alcohol use at baseline, adjusted by age, sex, ethnicity, deprivation, psychiatric diagnosis and employment', 'social support and greater physical activity, lower sedentary behaviour, healthier diet', 'risk of cardiovascular disease (CVD', 'social support', 'medication adherence']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",326.0,0.0483254,"No association was found between greater perceived social support and greater physical activity, lower sedentary behaviour, healthier diet, lower alcohol use or being a non-smoker.
CONCLUSIONS


Social support may be an important facilitator for CVD medication adherence and is potentially important for primary care appointment attendance; however, alternative strategies might be needed to help people with SMI engage in physical activity, healthier diets and to reduce their smoking and alcohol use.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Burton', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK. a.burton@ucl.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Walters', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Upper Third Floor, Rowland Hill Street, London, NW3 2PF, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th floor, 149 Tottenham Court Road, London, W1T 7NF, UK.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01879-9']
879,32040222,"A randomized pilot study of mindfulness-based stress reduction in a young adult cancer sample: Feasibility, acceptability, and changes in patient reported outcomes.","BACKGROUND


The primary purpose of this study was to examine the feasibility and acceptability of participation in a randomized waitlist-controlled intervention of mindfulness-based stress reduction (MBSR) in a young adult cancer sample. A secondary aim was to examine patterns of change in patient reported outcomes (PROs) of physical, social, and emotional functioning.
METHODS


Participants were enrolled at a large Midwestern comprehensive cancer center and randomized to MBSR or a waitlist control. Feasibility and acceptability were examined through enrollment metrics and a survey. PROs were gathered at baseline, 8-weeks, and 16-weeks. Descriptive statistics and mixed models were used in analyses.
RESULTS


Of 597 eligible participants, 151 (26.5%) consented from which 126 (83.4%) completed baseline measures. Sixty-seven participants were randomized to MBSR, and 59 to the waitlist. Immediately following MBSR, the majority of respondents (72%-78%) reported their experience with mindfulness was very logical and useful to increasing their wellbeing. Compared to waitlist members, MBSR participant's scores on PROs improved in expected directions.
CONCLUSIONS


Our findings suggest that recruitment for an intensive, in-person, multi-week supportive intervention can be challenging with young adults with cancer, similar to other cancer survivor populations; however once enrolled, feasibility and acceptability of MBSR was supported. Further, initial evidence on the role of MBSR on short-term changes in select PROs with this population was also demonstrated.",2020,"Immediately following MBSR, the majority of respondents (72-78%) reported their experience with mindfulness was very logical and useful to increasing their wellbeing.","['Sixty-seven participants', 'Of 597 eligible participants, 151 (26.5', 'young adult cancer sample', 'Young Adult Cancer Sample', 'young adults with cancer', 'Participants were enrolled at a large Midwestern comprehensive cancer center and randomized to MBSR or a waitlist control']","['mindfulness-based stress reduction (MBSR', 'MBSR', 'Mindfulness-Based Stress Reduction']","['outcomes (PROs) of physical, social and emotional functioning', 'Feasibility and acceptability', 'Feasibility, Acceptability', 'PROs']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",597.0,0.0358031,"Immediately following MBSR, the majority of respondents (72-78%) reported their experience with mindfulness was very logical and useful to increasing their wellbeing.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Victorson', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Karly', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Psychiatry and Behavioral Services, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bruriah', 'Initials': 'B', 'LastName': 'Horowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Maletich', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Cordero', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Salsman', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sanford', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Psycho-oncology,['10.1002/pon.5355']
880,32065601,Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial.,"Importance


Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited.
Objective


To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.
Design, Setting, and Participants


The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.
Interventions


In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%).
Main Outcomes and Measures


The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs.
Results


Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar.
Conclusions and Relevance


Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure.
Trial Registration


Netherlands Trial Register Identifier: NTR3764.",2020,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"['6 hospitals in the Netherlands in which 523 patients with stage 3 CKD', '262 patients', 'patients with stage', 'The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women', 'patients with stage 3 CKD', 'patients with stage 3 chronic kidney disease (CKD', 'Adults With Chronic Kidney Disease', '554 patients randomized', 'Data were analyzed from January 2018 to June 2019']","['prehydration', 'no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate', 'omitting prophylactic prehydration prior to iodine-based contrast media administration', 'Contrast-Enhanced Computed Tomography', 'No Prehydration vs Sodium Bicarbonate Prehydration']","['incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs', 'Postcontrast acute kidney injury', 'Mean hydration costs', 'serum creatinine level', 'mean (SD) relative increase in creatinine level', 'renal safety', 'safe and cost-efficient measure', 'acute heart failure']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",262.0,0.201305,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"[{'ForeName': 'Rohit J', 'Initials': 'RJ', 'LastName': 'Timal', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kooiman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yvo W J', 'Initials': 'YWJ', 'LastName': 'Sijpkens', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medisch Centrum Bronovo, The Hague, the Netherlands.'}, {'ForeName': 'Jean-Paul P M', 'Initials': 'JPM', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Iris J A M', 'Initials': 'IJAM', 'LastName': 'Verberk-Jonkers', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Harald F H', 'Initials': 'HFH', 'LastName': 'Brulez', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'van Buren', 'Affiliation': 'Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'van der Molen', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Cannegieter', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.7428']
881,32017092,Consumption of Lactobacillus reuteri-containing lozenges improves periodontal health in navy sailors at sea: A randomized controlled trial.,"BACKGROUND


The objective of this trial was to evaluate whether the regular consumption of probiotics may improve the known deterioration of periodontal health in navy sailors during deployments at sea.
METHODS


72 healthy sailors of a naval ship on a practicing mission at sea were recruited and randomly provided with a blinded supply of lozenges to be consumed twice daily for the following 42 days containing either the probiotic strains Lactobacillus reuteri (DSM 17938 and L. reuteri (ATTC PTA 5289) (test n = 36) or no probiotics (placebo n = 36). At baseline, at day 14 and day 42 bleeding on probing (primary outcome), gingival index, plaque control record, probing attachment level, and probing pocket depth were assessed at the Ramfjord teeth.
RESULTS


At baseline there were no significant differences between the groups. At day 14 and day 42 test group scores of all assessed parameters were significantly improved (P < 0.001) compared to baseline and to the placebo group which by contrast showed a significant (P < 0.001) deterioration of all parameters at the end of the study.
CONCLUSIONS


The consumption of probiotic L. reuteri-lozenges is an efficacious measure to improve and maintain periodontal health in situations with waning efficacy of personal oral hygiene.",2020,"At day 14 and day 42 test group scores of all assessed parameters were significantly improved (p<0.001) compared to baseline and to the placebo group which by contrast showed a significant (p<0.001) deterioration of all parameters at the end of the study.
","['72 healthy sailors of a naval ship on a practicing mission at sea', 'navy sailors at sea', 'navy sailors during deployments at sea']","['placebo', 'probiotic strains Lactobacillus reuteri (DSM 17938 and L. reuteri (ATTC PTA 5289) (test n = 36) or no probiotics (placebo', 'Lactobacillus reuteri-containing lozenges']","['gingival index, plaque control record, probing attachment level and probing pocket depth', 'periodontal health']","[{'cui': 'C0524646', 'cui_str': 'Sailors'}, {'cui': 'C0036971', 'cui_str': 'Ships'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",72.0,0.280807,"At day 14 and day 42 test group scores of all assessed parameters were significantly improved (p<0.001) compared to baseline and to the placebo group which by contrast showed a significant (p<0.001) deterioration of all parameters at the end of the study.
","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schlagenhauf', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Rehder', 'Affiliation': 'German Naval Medical Institute, Kronshagen, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Gelbrich', 'Affiliation': 'Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Jockel-Schneider', 'Affiliation': 'Department of Periodontology, University Hospital Würzburg, Würzburg, Germany.'}]",Journal of periodontology,['10.1002/JPER.19-0393']
882,32418011,Multi-modular bone healing assessment in a randomized controlled clinical trial of root-end surgery with the use of leukocyte- and platelet-rich fibrin and an occlusive membrane.,"OBJECTIVES


The aim of this study was to assess in a multi-modular manner the bone healing 1 year post root-end surgery (RES) with leukocyte- and platelet-rich fibrin (LPRF) and Bio-Gide® (BG; Geistlich Pharma North America, Inc., Princeton, USA) as an occlusive membrane.
MATERIALS AND METHODS


A randomized controlled clinical trial (RCT) of RES +/- LPRF and +/- BG was performed. The follow-up until 1 year post RES was performed by means of ultrasound imaging (UI), periapical radiographs (PR), and cone-beam computed tomography (CBCT).
RESULTS


From the 50 included patients, 6 dropped-out during follow-up. For the 44 assessed patients (34 with UI and 42 with PR and CBCT), there was no evidence (p > 0.05) for an effect of LRPF, neither on UI measurements nor on CBCT assessments. On the contrary, there was an indication for a better outcome with BG. UI presented significant shorter healing time for the bony crypt surface (p = 0.014) and cortical opening (p = 0.006) for the groups with BG. The qualitative CBCT assessment for the combined scores of the apical area and cortical plane was significantly higher for BG (p = 0.01 and 0.02). The quantitative CBCT measurement for bone healing after 1 year was lower with BG (p = 0.019), as well as the percentage of non-zero values (p = 0.026), irrespective of the preoperative lesion size and type. Furthermore, UI seemed to be safer for frequent follow-up during the early postoperative stage (0-3 months), whereas CBCT gave more accurate results 1 year post RES. Amongst the assessors, the qualitative PR analysis was inconsistent for a favorable outcome 1 year post RES with LPRF (p = 0.11 and p = 0.023), but consistent for BG (p = 0.024 and p = 0.023).
CONCLUSIONS


There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF. However, RES with BG gave evidence for a better outcome than RES without BG.
CLINICAL RELEVANCE


The addition of an occlusive membrane rather than an autologous platelet concentrate improved bone regeneration 1 year post RES significantly, irrespective of the assessment device applied. The accuracy of PR assessment is questionable.",2020,There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF.,[],"['bone healing 1\xa0year post root-end surgery (RES) with leukocyte- and platelet-rich fibrin (LPRF) and Bio-Gide® (BG', 'RES ', 'Multi-modular bone healing assessment', 'leukocyte- and platelet-rich fibrin', 'LPRF and ']","['healing time', 'bone healing', 'quantitative CBCT measurement for bone healing', 'cortical opening', 'bone regeneration 1']",[],"[{'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0539912', 'cui_str': 'Bio-Gide'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]",50.0,0.0871603,There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF.,"[{'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Meschi', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium. nastaran.meschi@kuleuven.be.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Vanhoenacker', 'Affiliation': 'Stomatology and Maxillofacial Surgery, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Strijbos', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Camargo Dos Santos', 'Affiliation': 'Department of Oral Health Sciences, BIOMAT - Biomaterials Research Group, Dentistry, KU Leuven (University of Leuven), Kapucijnenvoer 7 Blok a, Box 7001, 3000, Leuven, Belgium.'}, {'ForeName': 'Eléonore', 'Initials': 'E', 'LastName': 'Rubbers', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Peeters', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Curvers', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Van Mierlo', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Geukens', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Biostatistics and Statistical Bioinformatics Centre, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Verbeken', 'Affiliation': 'Translational Cell & Tissue Research, KU Leuven (University of Leuven), Leuven, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lambrechts', 'Affiliation': 'Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium.'}]",Clinical oral investigations,['10.1007/s00784-020-03309-1']
883,25421470,Population pharmacokinetics of micafungin and its metabolites M1 and M5 in children and adolescents.,"The aim of this analysis was to identify therapeutic micafungin regimens for children that produce the same micafungin exposures known to be effective for the prevention and treatment of Candida infections in adults. Pediatric pharmacokinetic data from 229 patients between the ages of 4 months and <17 years were obtained from four phase I and two phase III clinical trials. Population pharmacokinetic models were used to simulate the proportion of children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml. Simulated pediatric dosages of 0.5 to 5 mg/kg of body weight/day were explored. A two-compartment model was used that incorporated body weight as a predefined covariate for allometric scaling of the pharmacokinetic parameters. During construction of the model, aspartate aminotransferase and total bilirubin were also identified as covariates that had a significant effect on micafungin clearance. A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis. Cutoffs of 40 or 50 kg for weight-based dosing resulted in heavier children being appropriately dosed. Thus, dose regimens of 1, 2, and 3 mg/kg/day micafungin are appropriate for the prevention of invasive candidiasis, the treatment of invasive candidiasis, and the treatment of esophageal candidiasis, respectively, in children aged 4 months to <17 years.",2015,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"['children who had a steady-state area under the concentration-time curve at 24 hours (AUC24) of micafungin within the 10th to 90th percentile range observed in a population of adults receiving a dose of micafungin with established efficacy for invasive candidiasis (100 mg/day), i.e., 75 to 139 μg·h/ml', 'children and adolescents', 'children aged 4 months to <17 years', 'adults', '229 patients between the ages of 4 months and <17 years were obtained from four phase']",[],"['aspartate aminotransferase and total bilirubin', 'micafungin clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",[],"[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",229.0,0.0417469,A dose of 2 mg/kg resulted in the highest proportion of children within the predefined micafungin AUC24 target range for invasive candidiasis.,"[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom william.hope@liverpool.ac.uk.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Division of Infectious Disease, Orange, California, USA.""}, {'ForeName': 'Nkechi', 'Initials': 'N', 'LastName': 'Azie', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Kovanda', 'Affiliation': 'Astellas Pharma, Northbrook, Illinois, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Benjamin', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.03736-14']
884,25879690,"The effects of probiotics on mental health and hypothalamic-pituitary-adrenal axis: A randomized, double-blind, placebo-controlled trial in petrochemical workers.","OBJECTIVE


The aim of this study was to determine effects of probiotic yogurt and multispecies probiotic capsule supplementation on mental health and hypothalamic-pituitary-adrenal axis in petrochemical workers.
METHODS


The present randomized double-blind, placebo-controlled trial was conducted on 70 petrochemical workers. Subjects were randomly divided into three groups to receive 100 g/day probiotic yogurt + one placebo capsule (n = 25) or one probiotic capsule daily + 100 g/day conventional yogurt (n = 25) or 100 g/day conventional yogurt + one placebo capsule (n = 20) for 6 weeks. Mental health parameters including general health questionnaire (GHQ) and depression anxiety and stress scale (DASS) scores were measured. Fasting blood samples were obtained at the beginning and 6 weeks after the intervention to quantify hypothalamic-pituitary-adrenal axis.
RESULTS


After 6 weeks of intervention, a significant improvement of GHQ was observed in the probiotic yogurt (18.0 ± 1.5 vs. 13.5 ± 1.9, P = 0.007) and in the probiotic capsule group (16.9 ± 1.8 vs. 9.8 ± 1.9, P = 0.001), as well as a significant improvement in DASS scores in the probiotic yogurt (23.3 ± 3.7 vs. 13.0 ± 3.7, P = 0.02) and the probiotic capsule group (18.9 ± 3.2 vs. 9.4 ± 4.0, P = 0.006). However, there was no significant improvement in the conventional yogurt group (P = 0.05 for GHQ and P = 0.08 for DASS).
DISCUSSION


The consumption of probiotic yogurt or a multispecies probiotic capsule had beneficial effects on mental health parameters in petrochemical workers.",2016,"However, there was no significant improvement in the conventional yogurt group (P = 0.05 for GHQ and P = 0.08 for DASS).
","['petrochemical workers', '70 petrochemical workers']","['placebo', '100\u2005g/day probiotic yogurt\u2009+\u2009one placebo capsule (n\u2009=\u200925) or one probiotic capsule daily\u2009+\u2009100\u2005g/day conventional yogurt (n\u2009=\u200925) or 100\u2005g/day conventional yogurt\u2009+\u2009one placebo capsule', 'probiotic yogurt and multispecies probiotic capsule supplementation', 'probiotics']","['DASS scores', 'mental health parameters', 'mental health and hypothalamic-pituitary-adrenal axis', 'Fasting blood samples', 'general health questionnaire (GHQ) and depression anxiety and stress scale (DASS) scores', 'GHQ']","[{'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",,0.239257,"However, there was no significant improvement in the conventional yogurt group (P = 0.05 for GHQ and P = 0.08 for DASS).
","[{'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Mohammadi', 'Affiliation': 'a Department of Nutrition, School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Jazayeri', 'Affiliation': 'a Department of Nutrition, School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Kianoush', 'Initials': 'K', 'LastName': 'Khosravi-Darani', 'Affiliation': 'b Research Department of Food Technology Research , National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences , Tehran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Solati', 'Affiliation': 'c School of Nutritional Sciences and Dietetics , Tehran University of Medical Sciences , Iran.'}, {'ForeName': 'Nakisa', 'Initials': 'N', 'LastName': 'Mohammadpour', 'Affiliation': 'c School of Nutritional Sciences and Dietetics , Tehran University of Medical Sciences , Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'd Research Center for Biochemistry and Nutrition in Metabolic Diseases , Kashan University of Medical Sciences , Iran.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Adab', 'Affiliation': 'c School of Nutritional Sciences and Dietetics , Tehran University of Medical Sciences , Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'c School of Nutritional Sciences and Dietetics , Tehran University of Medical Sciences , Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Tehrani-Doost', 'Affiliation': 'e Department of Psychiatry, Roozbeh Hospital , Tehran University of Medical Sciences , Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'f Department of Epidemiology and Biostatistics, School of Public Health , Tehran University of Medical Sciences , Iran.'}, {'ForeName': 'Shahryar', 'Initials': 'S', 'LastName': 'Eghtesadi', 'Affiliation': 'a Department of Nutrition, School of Public Health , Iran University of Medical Sciences , Tehran , Iran.'}]",Nutritional neuroscience,[]
885,25555626,Academic Outcomes Following a School-Based RCT for ADHD: 6-Year Follow-Up.,"Objective:  For children with high levels of ADHD symptoms, to investigate the impact of early school-based interventions on academic outcomes in mid-childhood.  Method:  A 6-year follow-up of 4- to 5-year-olds ( N  = 52,075) whose schools participated in a cluster randomized controlled trial for children at risk of ADHD. School-level interventions involved the provision of a booklet with evidence-based information (book) and/or feedback of names (identification) of children with high levels of ADHD symptoms. At ages 10 to 11 years, outcome measures were scores in English and mathematics tests.  Results:  For children with high levels of ADHD symptoms, the interventions had no impact on academic outcomes. When all children were analyzed, the book intervention had a positive impact on mathematics. Baseline inattention was associated with poorer academic outcomes, whereas impulsiveness was associated with better academic outcomes.  Conclusion:  The provision of evidence-based information about helping children with ADHD at school may have wider academic benefits.",2020,"Baseline inattention was associated with poorer academic outcomes, whereas impulsiveness was associated with better academic outcomes.
","['A 6-year follow-up of 4- to 5-year-olds (N = 52,075) whose schools participated in a cluster randomized controlled trial for children at risk of ADHD', 'children with high levels of ADHD symptoms']","['School-Based RCT for ADHD', 'booklet with evidence-based information (book) and/or feedback of names (identification']",['scores in English and mathematics tests'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0425119', 'cui_str': 'Child at risk (finding)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",52075.0,0.071229,"Baseline inattention was associated with poorer academic outcomes, whereas impulsiveness was associated with better academic outcomes.
","[{'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'University of Nottingham, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Merrell', 'Affiliation': 'Durham University, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tymms', 'Affiliation': 'Durham University, UK.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Durham University, UK.'}]",Journal of attention disorders,['10.1177/1087054714562588']
886,32424499,Does physiotherapy applied in conjunction with compression brace treatment in patients with pectus carinatum have efficacy? A preliminary randomized-controlled study.,"PURPOSE


Non-invasive treatment of pectus carinatum (PC) deformity includes the use of a compression brace and exercises. In this study, we aimed to examine the effect of a physiotherapy protocol applied as adjunct to compression brace treatment in patients with PC.
METHODS


The study included 30 male patients between 11 and 18 years of age. Patients were randomly assigned into two groups: a brace treatment only group (Group 1) and a brace and physiotherapy group (Group 2). Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction were evaluated.
RESULTS


Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05). Additionally, we found that patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores were significantly better in Group 2 (p < 0.05).
CONCLUSION


Owing to the satisfaction and additional benefits observed in the physiotherapy group, we think that a proper cardiopulmonary and musculoskeletal exercise program should be applied concurrently with brace treatment for patients with PC deformity. Nevertheless, long-term outcomes need to be clarified in future studies.",2020,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","['patients with pectus carinatum', 'patients with PC deformity', 'patients with PC', '30 male patients between 11 and 18\xa0years of age']","['physiotherapy protocol', 'compression brace and exercises', 'brace treatment only group (Group 1) and a brace and physiotherapy', 'musculoskeletal exercise program']","['Patient demographics and disease-related properties, protrusion measurements, postural evaluations, deformity perceptions, life quality, and treatment satisfaction', 'maximum protrusion degree and lateral length values', 'patient perception of deformity, posture, psychological life quality, and treatment satisfaction scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0533754,"Although both groups showed improvements based on external chest measurements related to PC protrusion following treatment (p < 0.001), Group 2 had more benefit from the treatment (effect size > 0.36) and displayed greater improvement in maximum protrusion degree and lateral length values (p < 0.05).","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey. nuray.alaca@acibadem.edu.tr.'}, {'ForeName': 'İhsan', 'Initials': 'İ', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Kerem Aydınlar Kampusu, Icerenkoy Mah. Kayısdagı Cad. No:32, Atasehir, 34752, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yüksel', 'Affiliation': 'Chest Wall Deformities and Pectus Association, Zuhtupasa Mah. Kadıkoy, Istanbul, Turkey.'}]",Pediatric surgery international,['10.1007/s00383-020-04675-3']
887,31837091,Acute responses of comprehensive gonadosteroids and corticosteroids to resistance exercise before and after 10 weeks of supervised strength training.,"NEW FINDINGS


What is the central question of this study? Although acute responses of the principal gonadosteroid and corticosteroid hormones to resistance exercise are well documented, there is no information regarding how the key lower-concentration intermediary hormones respond and potentially influence these hormonal pathways. What is the main finding and its importance? This study provides evidence for cascading conversions of some gonadosteroids, and the data suggest that the testosterone concentration increases independently of these hormones. These findings challenge future studies to determine the exact physiological roles of the lower-concentration gonadosteroids and corticosteroids during and immediately after resistance exercise.
ABSTRACT


Resistance training is a potent stimulus for muscle growth, and steroid hormones are known to play a role in this adaptation. However, very little is known about the acute exercise-induced gonadosteroid and corticosteroid hormone responses, including those of key lower-concentration intermediate hormones. The present study determined the acute responses of these steroid hormone families using quantitative ultra-high performance liquid chromatography tandem mass spectrometry after resistance exercise in strength-trained men. Venous and fingertip blood samples were obtained pre-, mid-, 5 min post- and 15 min post-resistance exercise, both before and after 10 weeks of supervised resistance training. The experimental resistance exercise sessions consisted of three sets of 10 repetitions of bilateral leg-press exercise and three sets of 10 repetitions of unilateral knee-extension exercise, with 2 and 1 min recovery between sets, respectively. Statistically significant (P < 0.05) increases in the concentration of hormones in the gonadosteroid [including dehydroepiandrosterone (DHEA), androstenedione, testosterone and estrone] and the corticosteroid (including cortisol, corticosterone and cortisone) families were demonstrated after both experimental resistance exercise sessions, irrespective of training status. Correlation analyses revealed relationships between the following hormones: (i) DHEA and androstenedione; (ii) DHEA and cortisol; (iii) androstenedione and estrone; and (iv) 11-deoxycortisol and cortisol. Testosterone appears to increase acutely and independently of other intermediary hormones after resistance exercise. In conclusion, lower-concentration intermediary gonadosteroids (e.g. estrone) and corticosteroids (e.g. corticosterone) respond robustly to resistance exercise in strength-trained men, although it seems that testosterone concentrations are regulated by factors other than the availability of precursor hormones and changes in plasma volume.",2020,"Statistically significant (P < 0.05) increases in the concentration of hormones in the gonadosteroid [including dehydroepiandrosterone (DHEA), androstenedione, testosterone and estrone] and the corticosteroid (including cortisol, corticosterone and cortisone) families were demonstrated after both experimental resistance exercise sessions, irrespective of training status.",['strength-trained men'],"['Testosterone', 'comprehensive gonadosteroids and corticosteroids to resistance exercise', 'bilateral leg-press exercise and three sets of 10 repetitions of unilateral knee-extension exercise', 'pre-, mid-, 5\xa0min post- and 15']","['i) DHEA and androstenedione; (ii) DHEA and cortisol; (iii) androstenedione and estrone; and (iv) 11-deoxycortisol and cortisol', 'Venous and fingertip blood samples', 'concentration of hormones in the gonadosteroid [including dehydroepiandrosterone (DHEA), androstenedione, testosterone and estrone] and the corticosteroid (including cortisol, corticosterone and cortisone) families']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0010139', 'cui_str': '11-Desoxycortisol'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0373588', 'cui_str': 'Corticosterone measurement (procedure)'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",,0.0367148,"Statistically significant (P < 0.05) increases in the concentration of hormones in the gonadosteroid [including dehydroepiandrosterone (DHEA), androstenedione, testosterone and estrone] and the corticosteroid (including cortisol, corticosterone and cortisone) families were demonstrated after both experimental resistance exercise sessions, irrespective of training status.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Keijo', 'Initials': 'K', 'LastName': 'Häkkinen', 'Affiliation': 'NeuroMuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Centre for Exercise and Sports Science Research (CESSR), Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Markworth', 'Affiliation': 'Department of Molecular and Integrative Physiology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Pundir', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Guy G', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'Centre for Exercise and Sports Science Research (CESSR), Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research (CESSR), Edith Cowan University, Joondalup, WA, Australia.'}]",Experimental physiology,['10.1113/EP087995']
888,22676245,Randomized phase II study of three doses of oral TAS-108 in postmenopausal patients with metastatic breast cancer.,"This randomized phase II study was intended to identify the optimal dose of TAS-108, a novel steroidal antiestrogen, for the treatment of breast cancer in postmenopausal Japanese women. The potential clinical effects of TAS-108 on the uterus, bone, serum lipids, and hormones were also investigated. Postmenopausal women with hormone receptor-positive metastatic breast cancer who had previously received one or two endocrine therapies were randomly assigned to one of the three possible dose levels of TAS-108 (40, 80 or 120 mg/day). Oral TAS-108 was given daily, and the efficacy and safety of the three doses were evaluated. A total of 97 patients (33, 32, and 32 in the 40-, 80-, and 120-mg groups, respectively) were treated with TAS-108. The clinical benefit rate was 30.3% for the 40-mg, 25.0% for the 80-mg, and 25.0% for the 120-mg group. The 40-mg group achieved the prespecified target threshold. TAS-108 at all dose levels was well tolerated and appeared to have no harmful effects in terms of the variables examined in this study. We conclude that the optimal dose of TAS-108 among the three doses is 40 mg, once daily, for further studies. JAPIC Clinical Trials Information number: Japic CTI - 121754.",2012,TAS-108 at all dose levels was well tolerated and appeared to have no harmful effects in terms of the variables examined in this study.,"['postmenopausal patients with metastatic breast cancer', 'postmenopausal Japanese women', 'Postmenopausal women with hormone receptor-positive metastatic breast cancer who had previously received one or two endocrine therapies', 'A total of 97 patients (33, 32, and 32 in the 40-, 80-, and 120-mg groups, respectively) were treated with']","['Oral TAS-108', 'oral TAS-108', 'TAS-108, a novel steroidal antiestrogen', 'TAS-108']","['efficacy and safety', 'clinical benefit rate', 'uterus, bone, serum lipids, and hormones']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0752229', 'cui_str': 'Antiestrogens'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]",97.0,0.0255261,TAS-108 at all dose levels was well tolerated and appeared to have no harmful effects in terms of the variables examined in this study.,"[{'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Inaji', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': ''}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': ''}, {'ForeName': 'Naohito', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Tokuda', 'Affiliation': ''}, {'ForeName': 'Kenjiro', 'Initials': 'K', 'LastName': 'Aogi', 'Affiliation': ''}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': ''}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': ''}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': ''}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Saeki', 'Affiliation': ''}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takatsuka', 'Affiliation': ''}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kuranami', 'Affiliation': ''}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kikuchi', 'Affiliation': ''}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Tabei', 'Affiliation': ''}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': ''}, {'ForeName': 'Shinzaburo', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': ''}]",Cancer science,['10.1111/j.1349-7006.2012.02354.x']
889,32427108,User Experiences of an Internet-Based Stepped-Care Intervention for Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression (the U-CARE AdultCan Trial): Qualitative Study.,"BACKGROUND


The internet-based stepped-care intervention iCAN-DO, used in the multicenter randomized controlled trial AdultCan, was developed for adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms. iCAN-DO aimed to decrease symptoms of anxiety or depression. Step 1 comprises access to a library with psychoeducational material and a peer-support section, as well as the possibility to pose questions to a nurse. Step 2 of the intervention offers treatment consisting of internet-based cognitive behavioral therapy (iCBT) to participants still experiencing anxiety or depression at 1, 4, or 7 months after inclusion.
OBJECTIVE


The study aimed to explore user experiences of delivery, design, and structure of iCAN-DO from the perspective of people with cancer.
METHODS


We studied user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9). The interviews focused on informants' perceptions of ease of use and of system design and structure. Informants had been included in iCAN-DO for at least 7 months. They were purposefully selected based on activity in Step 1, participation in iCBT (ie, Step 2), gender, and diagnosis.
RESULTS


Of the 15 informants, 6 had been offered iCBT (40%). All informants used the internet on a daily basis, but 2 (13%) described themselves as very inexperienced computer users. The analysis revealed three subthemes, concerning how user experiences were affected by disease-specific factors and side effects (User experience in the context of cancer), technical problems (Technical struggles require patience and troubleshooting), and the structure and design of iCAN-DO (Appealing and usable, but rather simple).
CONCLUSIONS


The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences. The results have generated some developments feasible to launch during the ongoing study, but if iCAN-DO is to be used beyond research interest, a greater level of tailoring of information, features, and design may be needed to improve user experiences. The use of recurrent questionnaires during the treatment period may highlight an individual's health, but also function as a motivator showing improvements over time.",2020,"The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences.","['user experiences by interviewing 15 informants individually: 10 women with breast cancer (67%), 4 men with prostate cancer (27%), and 1 man with colorectal cancer (7%) with a mean age 58.9 years (SD 8.9', 'adult patients undergoing treatment for cancer and concurrently experiencing anxiety or depressive symptoms', 'Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression', 'people with cancer']","['internet-based cognitive behavioral therapy (iCBT', 'Internet-Based Stepped-Care Intervention']",[],"[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],10.0,0.0532678,"The results indicate that user experiences were affected by informants' life situations, the technical aspects and the design of iCAN-DO, and informants' preferences.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Igelström', 'Affiliation': 'Department of Neuroscience, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hauffman', 'Affiliation': 'Department of Immmunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Alfonsson', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Sjöström', 'Affiliation': 'Department of Informatics and Media, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Cajander', 'Affiliation': 'Department of Information Technology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immmunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.'}]",Journal of medical Internet research,['10.2196/16604']
890,23480146,Early tumor shrinkage in metastatic colorectal cancer: retrospective analysis from an irinotecan-based randomized first-line trial.,"Early tumor shrinkage (ETS) has been highlighted as a favorable prognostic factor related to progression-free survival (PFS) and overall survival (OS) in cytotoxic treatment of metastatic colorectal cancer. Data from a randomized phase III study comparing infusional 5-fluorouracil plus irinotecan (FUFIRI) versus irinotecan plus oxaliplatin (mIROX) were evaluated. Patient groups were analyzed according to the relative change in maximum tumor diameter between baseline and after 7 weeks of treatment. The ETS cohort was defined as a decrease of ≥20%. Additionally, the non-ETS cohort was subdivided into ""minor shrinkage"" (0-19%), ""tumor progression"" (any increase) and development of ""new metastatic lesions"". Progression-free survival and OS were estimated in all patient subgroups. Assessment of ETS was possible in 201 patients. Early tumor shrinkage was observed in 47% (94/201) and non-ETS in 53% (107/201) of patients. Patients with ETS had a more favorable outcome with regard to PFS (9.9 months vs 6.1 months, P = 0.029) and OS (27.5 months vs 17.8 months, P = 0.002). In the non-ETS subgroups, patients with ""minor shrinkage"" (PFS 8.4 months, OS 21.6 months) showed a markedly better outcome than patients with ""early tumor progression"" (PFS 4.0 months, OS 15.3 months) or with ""new metastatic lesions (PFS 2.2 months, OS 7.6 months). In conclusion, ETS assessment offers accelerated response evaluation when compared to RECIST. In patients treated with chemotherapy alone, ETS ≥20% is associated with excellent outcome. Non-ETS is a heterogeneous subgroup where patients with minor shrinkage clearly benefit from treatment, and patients with early progression or development of new lesions have an unfavorable prognosis.",2013,"Patients with ETS had a more favorable outcome with regard to PFS (9.9 months vs 6.1 months, P = 0.029) and OS (27.5 months vs 17.8 months, P = 0.002).","['201 patients', 'metastatic colorectal cancer']","['infusional 5-fluorouracil plus irinotecan (FUFIRI) versus irinotecan plus oxaliplatin (mIROX', 'chemotherapy', 'ETS']","['progression-free survival (PFS) and overall survival (OS', 'Progression-free survival and OS', 'minor shrinkage', 'PFS', 'Early tumor shrinkage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]",,0.0194084,"Patients with ETS had a more favorable outcome with regard to PFS (9.9 months vs 6.1 months, P = 0.029) and OS (27.5 months vs 17.8 months, P = 0.002).","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Giessen', 'Affiliation': 'Department of Medical Oncology, Klinikum Grosshadern and Comprehensive Cancer Center, Ludwig-Maximilians-University of Munich, Munich, Germany. clemens.giessen@med.uni-muenchen.de'}, {'ForeName': 'Ruediger P', 'Initials': 'RP', 'LastName': 'Laubender', 'Affiliation': ''}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schalhorn', 'Affiliation': ''}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': ''}, {'ForeName': 'Ulrich R', 'Initials': 'UR', 'LastName': 'Mansmann', 'Affiliation': ''}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': ''}]",Cancer science,['10.1111/cas.12148']
891,23298271,Circulating endothelial cells and tumor blood volume as predictors in lung cancer.,"The current criteria for evaluating antiangiogenic efficacy is insufficient as tumor shrinkage occurs after blood perfusion decreases. Tumor blood volume (BV) in computed tomography perfusion imaging and circulating endothelial cells (CEC) might predict the status of angiogenesis. The present study aimed to validate their representation as feasible predictors in non-small-cell lung carcinoma (NSCLC). A total of 74 patients was categorized randomly into two arms undergoing regimens of vinorelbine and cisplatin (Navelbine and platinum [NP]) with rh-endostatin or single NP. The response rate, perfusion imaging indexes and activated CEC (aCEC) during treatment were recorded. Progression-free survival (PFS) was determined through follow up. Correlations among the above indicators, response and PFS were analyzed: aCEC increased significantly in cases of progressive disease after single NP chemotherapy (P = 0.024). Tumor BV decreased significantly in cases with a clinical benefit in the combined arm (P = 0.026), whereas inverse correlations existed between ∆aCEC (post-therapeutic value minus the pre-therapeutic value) and PFS (P = 0.005) and between ∆BV and PFS (P = 0.044); a positive correlation existed between ∆aCEC and ∆BV. Therefore, both aCEC and tumor BV can serve as predictors, and detection of both indicators can help evaluate the chemo-antiangiogenic efficacy in NSCLC more accurately.",2013,"Tumor BV decreased significantly in cases with a clinical benefit in the combined arm (P = 0.026), whereas inverse correlations existed between ∆aCEC (post-therapeutic value minus the pre-therapeutic value) and PFS (P = 0.005) and between ∆BV and PFS (P = 0.044); a positive correlation existed between ∆aCEC and ∆BV.","['74 patients', 'lung cancer', 'non-small-cell lung carcinoma (NSCLC']",['vinorelbine and cisplatin (Navelbine and platinum [NP]) with rh-endostatin or single NP'],"['response rate, perfusion imaging indexes and activated CEC (aCEC', '∆BV and PFS', 'Tumor blood volume (BV', 'Tumor BV', 'Progression-free survival (PFS', 'Circulating endothelial cells and tumor blood volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0131965', 'cui_str': 'Navelbine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0534628', 'cui_str': 'Endostatins'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus (organism)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}]",74.0,0.0313669,"Tumor BV decreased significantly in cases with a clinical benefit in the combined arm (P = 0.026), whereas inverse correlations existed between ∆aCEC (post-therapeutic value minus the pre-therapeutic value) and PFS (P = 0.005) and between ∆BV and PFS (P = 0.044); a positive correlation existed between ∆aCEC and ∆BV.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Xiyin', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'Liuchun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Zhujun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Baocun', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ''}]",Cancer science,['10.1111/cas.12097']
892,32427113,A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness.,"BACKGROUND


The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated.
OBJECTIVE


This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored.
METHODS


This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement.
RESULTS


A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t 116 =2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI -7.423 to 6.301), and hemoglobin A 1c  was 4.5 mmol/mol (95% CI -13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction.
CONCLUSIONS


Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.",2020,"Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37).","['patients with either or both hypertension and type 2 diabetes', 'nonadherent patients with either or both hypertension and type 2 diabetes', '135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years', 'Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting']","['control group that received usual care', 'highly tailored digital intervention', 'Tailored Text and Voice Messaging Intervention', 'highly tailored text message and interactive voice response intervention']","['Medication adherence', 'intentional nonadherence and nonintentional nonadherence', 'Systolic blood pressure and glucose levels', 'quality of life and mechanisms of behavior change', 'behavioral efficacy', 'Intervention fidelity, engagement, and satisfaction', 'Systolic blood pressure', 'Medication Adherence', 'high fidelity, engagement, and satisfaction', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}]",135.0,0.110415,"Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37).","[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kassavou', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Mirzaei', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brimicombe', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Edwards', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Efthalia', 'Initials': 'E', 'LastName': 'Massou', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial College London, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The University of Cambridge, Cambridge, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16629']
893,23419915,Physiotherapists systematically overestimate the amount of time stroke survivors spend engaged in active therapy rehabilitation: an observational study.,"QUESTIONS


How accurately do physiotherapists estimate how long stroke survivors spend in physiotherapy sessions and the amount of time stroke survivors are engaged in physical activity during physiotherapy sessions? Does the mode of therapy (individual sessions or group circuit classes) affect the accuracy of therapists' estimates?
DESIGN


Observational study embedded within a randomised trial.
PARTICIPANTS


People who participated in the CIRCIT trial after having a stroke.
INTERVENTION


47 therapy sessions scheduled and supervised by physiotherapists (n = 8) and physiotherapy assistants (n = 4) for trial participants were video-recorded.
OUTCOME MEASURES


Therapists' estimations of therapy time were compared to the video-recorded times.
RESULTS


The agreement between therapist-estimated and video-recorded data for total therapy time and active time was excellent, with intraclass correlation coefficients (ICC) of 0.90 (95% CI 0.83 to 0.95) and 0.83 (95% CI 0.73 to 0.93) respectively. Agreement between therapist-estimated and video-recorded data for inactive time was good (ICC score 0.62, 95% CI 0.40 to 0.77). The mean (SD) difference between therapist-estimated and video-recorded total therapy time, active time, and inactive time for all sessions was 7.7 (10.5), 14.1 (10.3) and -6.9 (9.5) minutes respectively. Bland-Altman analyses revealed a systematic bias of overestimation of total therapy time and total active time, and underestimation of inactive time by therapists. Compared to individual therapy sessions, therapists estimated total circuit class therapy duration more accurately, but estimated active time within circuit classes less accurately.
CONCLUSION


Therapists are inaccurate in their estimation of the amount of time stroke survivors are active during therapy sessions. When accurate therapy data are required, use of objective measures is recommended.",2013,"Agreement between therapist-estimated and video-recorded data for inactive time was good (ICC score 0.62, 95% CI 0.40 to 0.77).",['People who participated in the CIRCIT trial after having a stroke'],"['active therapy rehabilitation', '47 therapy sessions scheduled and supervised by physiotherapists (n = 8) and physiotherapy assistants']","['mean (SD) difference between therapist-estimated and video-recorded total therapy time, active time, and inactive time', 'total therapy time and active time', 'video-recorded times', ""Therapists' estimations of therapy time"", 'systematic bias of overestimation of total therapy time and total active time, and underestimation of inactive time by therapists']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0586925', 'cui_str': 'Physiotherapy assistant'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0005351', 'cui_str': 'Systematic Bias'}]",,0.0715446,"Agreement between therapist-estimated and video-recorded data for inactive time was good (ICC score 0.62, 95% CI 0.40 to 0.77).","[{'ForeName': 'Gurpreet', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'School of Health Sciences, University of South Australia, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hillier', 'Affiliation': ''}]",Journal of physiotherapy,['10.1016/S1836-9553(13)70146-2']
894,24276281,CD44 is prognostic for overall survival in the NCI randomized trial on breast conservation with 25 year follow-up.,"CD44 is a transmembrane glycoprotein involved in numerous cellular functions, including cell adhesion and extracellular matrix interactions. It is known to be functionally diverse, with alternative splice variants increasingly implicated as a marker for tumor-initiating stem cells associated with poor prognosis. Here, we evaluate CD44 as a potential marker of long-term breast cancer outcomes. Tissue specimens from patients treated on the National Cancer Institute 79-C-0111 randomized trial of breast conservation versus mastectomy between 1979 and 1987 were collected, and immunohistochemistry was performed using the standard isoform of CD44. Specimens were correlated with patient characteristics and outcomes. Survival analysis was performed using the log rank test. Fifty-one patients had evaluable tumor sections and available long-term clinical follow up data at a median follow up of 25.7 years. Significant predictors of OS were tumor size (median OFS 25.4 years for ≤2 cm vs. 7.5 years for >2 cm, p = 0.001), nodal status (median OS 17.2 years for node-negative patients vs. 6.7 years for node positive patients, p = 0.017), and CD44 expression (median OS 18.9 years for CD44 positive patients vs. 8.6 years for CD44 negative patients, p = 0.049). There was a trend toward increased PFS for patients with CD44 positive tumors (median PFS 17.9 vs. 4.3 years, p = 0.17), but this did not reach statistical significance. These findings illustrate the potential utility of CD44 as a prognostic marker for early stage breast cancer. Subgroup analysis in patients with lymph node involvement revealed CD44 positivity to be most strongly associated with increased survival, suggesting a potential role of CD44 in decision making for axillary management. As there is increasing interest in CD44 as a therapeutic target in ongoing clinical trials, the results of this study suggest additional investigation regarding the role CD44 in breast cancer is warranted.",2014,"There was a trend toward increased PFS for patients with CD44 positive tumors (median PFS 17.9 vs. 4.3 years, p = 0.17), but this did not reach statistical significance.",['Tissue specimens from patients treated on the National Cancer Institute 79-C-0111 randomized trial of breast conservation versus mastectomy between 1979 and 1987'],['CD44'],"['Survival analysis', 'overall survival', 'PFS', 'survival', 'nodal status', 'CD44 expression']","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}]","[{'cui': 'C1120824', 'cui_str': 'CD44v9 antigen'}]","[{'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1120824', 'cui_str': 'CD44v9 antigen'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0407758,"There was a trend toward increased PFS for patients with CD44 positive tumors (median PFS 17.9 vs. 4.3 years, p = 0.17), but this did not reach statistical significance.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dan', 'Affiliation': 'Department of Radiation Oncology, Bodine Center for Cancer Treatment, Kimmel Cancer Center, Jefferson Medical College of Thomas Jefferson University, 111 S. 11th Street G-301G, Philadelphia, PA, 19107, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Hewitt', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ohri', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ly', 'Affiliation': ''}, {'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Soule', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Council', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Shankavaram', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Lippman', 'Affiliation': ''}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Camphausen', 'Affiliation': ''}, {'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Simone', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-013-2758-9']
895,31558379,Randomized Controlled Trial of Exercise and Nutrition Supplementation on Physical and Cognitive Function in Older Chinese Adults Aged 50 Years and Older.,"OBJECTIVES


To assess whether a 24-week multidomain lifestyle intervention including a nutritional milk supplement and an exercise program had any effect on physical and cognitive function, self-rated health, and health-related quality of life in older Chinese adults.
DESIGN


Randomized controlled trial.
SETTING AND PARTICIPANTS


Community-living people aged 50 years and older.
METHODS


180 participants (mean age 61 ± 6 years) were randomized to 24 weeks of exercise plus nutrition supplementation or no intervention. The primary outcome was gait speed, with additional physical and cognitive function measures, self-rated health, and health-related quality of life as secondary outcomes. Information collected also included dietary intake by 3-day dietary records, and blood sampling for renal function, glycated hemoglobin, serum vitamin B 12 , 25-hydroxyvitamin D, and biochemical indices of bone turnover.
RESULTS


There was no significant group difference in the change of gait speed, muscle strength, muscle power, cardiovascular fitness, or cognitive function over time, either by intention-to-treat or per-protocol analysis. A significant time × group effect (P = .039) on self-rated health was detected, but there was no significant time or time × group difference in the change of physical and mental health-related quality of life measures over time. In addition, moderate physical activity level was greatly increased from baseline to 24 weeks in the intervention group compared with the control group.
CONCLUSIONS AND IMPLICATIONS


A 24-week exercise and nutrition supplementation program among community-living people in late midlife to early old age improved self-rated health and the overall level of physical activity, without objective improvements in physical and cognitive function.",2020,"There was no significant group difference in the change of gait speed, muscle strength, muscle power, cardiovascular fitness, or cognitive function over time, either by intention-to-treat or per-protocol analysis.","['Community-living people aged 50\xa0years and older', '180 participants (mean age 61\xa0±\xa06\xa0years', 'Aged 50\xa0Years and Older', 'older Chinese adults', 'Older Chinese Adults', 'community-living people in late midlife to early old age']","['exercise and nutrition supplementation program', 'Exercise and Nutrition Supplementation', 'nutritional milk supplement and an exercise program', 'exercise plus nutrition supplementation or no intervention', 'multidomain lifestyle intervention']","['self-rated health', 'Physical and Cognitive Function', 'blood sampling for renal function, glycated hemoglobin, serum vitamin B 12 , 25-hydroxyvitamin D, and biochemical indices of bone turnover', 'physical and cognitive function, self-rated health, and health-related quality of life', 'change of gait speed, muscle strength, muscle power, cardiovascular fitness, or cognitive function over time, either by intention-to-treat or per-protocol analysis', 'gait speed, with additional physical and cognitive function measures, self-rated health, and health-related quality of life as secondary outcomes', 'change of physical and mental health-related quality of life measures', 'moderate physical activity level']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",180.0,0.145036,"There was no significant group difference in the change of gait speed, muscle strength, muscle power, cardiovascular fitness, or cognitive function over time, either by intention-to-treat or per-protocol analysis.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong. Electronic address: jeanwoowong@cuhk.edu.hk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sherlin', 'Initials': 'S', 'LastName': 'Ong', 'Affiliation': 'FrieslandCampina, LE Amersfoort, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Bragt', 'Affiliation': 'FrieslandCampina, LE Amersfoort, the Netherlands.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bos', 'Affiliation': 'FrieslandCampina, LE Amersfoort, the Netherlands.'}, {'ForeName': 'Panam', 'Initials': 'P', 'LastName': 'Parikh', 'Affiliation': 'FrieslandCampina, LE Amersfoort, the Netherlands.'}, {'ForeName': 'Lisette Cpgm', 'Initials': 'LC', 'LastName': 'de Groot', 'Affiliation': 'Wageningen University, Division of Human Nutrition and Health, Wageningen, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.001']
896,31558380,Optimizing Prescribing of Antipsychotics in Long-Term Care (OPAL): A Stepped-Wedge Trial.,"BACKGROUND


Inappropriate antipsychotic prescribing is a key quality indicator by which clinical outcomes might be monitored and improved in long-term care (LTC), but limited evidence exists on the most effective strategies for reducing inappropriate antipsychotic use.
OBJECTIVES


The objective of the study was to evaluate a multicomponent approach to reduce inappropriate prescribing of antipsychotics in LTC.
DESIGN


A prospective, stepped-wedge study design was used to evaluate the effect of the intervention.
SETTINGS AND PARTICIPANTS


Interdisciplinary staff at 10 Canadian LTC facilities.
METHODS


The intervention consisted of an educational in-service, provision of evidence-based tools to assess and monitor neuropsychiatric symptoms (NPS) in dementia, and monthly interprofessional team meetings. The primary outcome was the proportion of residents receiving an antipsychotic without a diagnosis of psychosis using a standardized antipsychotic quality indicator.
RESULTS


The weighted mean change in inappropriate antipsychotic prescribing rate from baseline to 12-month follow-up was -4.6% [standard deviation (SD) = 2.8%, P < .0001], representing a 16.1% (SD = 17.0) relative reduction. After adjusting for site, the odds ratio for the inappropriate antipsychotic prescribing quality indicator at 12 months compared to baseline was 0.73 (95% confidence interval = 0.48-0.94; chi-square = 6.59; P = .01). There were no significant changes in related quality indicators, including falls, restraint use, or behavioral symptoms.
CONCLUSIONS AND IMPLICATIONS


This multicomponent intervention was effective in reducing inappropriate antipsychotic prescribing in LTC without adversely affecting other domains related to quality of care, and offers a practical means by which to improve the care of older adults with dementia in LTC.",2020,"This multicomponent intervention was effective in reducing inappropriate antipsychotic prescribing in LTC without adversely affecting other domains related to quality of care, and offers a practical means by which to improve the care of older adults with dementia in LTC.","['older adults with dementia in LTC', 'Interdisciplinary staff at 10 Canadian LTC facilities', 'Long-Term Care (OPAL']",[],"['related quality indicators, including falls, restraint use, or behavioral symptoms', 'inappropriate antipsychotic prescribing rate', 'proportion of residents receiving an antipsychotic without a diagnosis of psychosis using a standardized antipsychotic quality indicator']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0023977'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]",,0.21563,"This multicomponent intervention was effective in reducing inappropriate antipsychotic prescribing in LTC without adversely affecting other domains related to quality of care, and offers a practical means by which to improve the care of older adults with dementia in LTC.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kirkham', 'Affiliation': ""Division of Geriatric Psychiatry, Queen's University, Kingston, Ontario, Canada. Electronic address: kirkhamj@providencecare.ca.""}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Maxwell', 'Affiliation': 'School of Pharmacy and Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Velkers', 'Affiliation': ""Division of Geriatric Psychiatry, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Leung', 'Affiliation': ""Division of Geriatric Psychiatry, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Moffat', 'Affiliation': ""Division of Geriatric Psychiatry, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Dallas', 'Initials': 'D', 'LastName': 'Seitz', 'Affiliation': ""Division of Geriatric Psychiatry, Queen's University, Kingston, Ontario, Canada.""}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.07.025']
897,31833590,Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up.,,2020,,"['out-patients with 1-year follow-up', 'high-risk alcohol consumption']","['placebo', 'Titrated baclofen']",[],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}]",[],,0.179507,,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Rigal', 'Affiliation': 'Université Paris-Saclay, UVSQ, Inserm, CESP, Villejuif, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Sidorkiewicz', 'Affiliation': 'Université de Paris, Faculté de Santé, UFR de Médecine, Département de Médecine Générale, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Tréluyer', 'Affiliation': 'Unité de recherche clinique, School of Medicine, Paris Descartes University, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Perrodeau', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Le Jeunne', 'Affiliation': 'Service de médecine interne APHP-Hôpital Cochin, Paris, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jaury', 'Affiliation': 'Université de Paris, Faculté de Santé, UFR de Médecine, Département de Médecine Générale, Paris, France.'}]","Addiction (Abingdon, England)",['10.1111/add.14927']
898,23331518,"Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years.","A randomized double-blind placebo-controlled phase II trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types most frequently associated with cervical cancer (types 16/18) and genital warts (types 6/11) in Japanese women aged 18-26 years. Participants were randomly assigned to either quadrivalent HPV (types 6/11/16/18) L1 virus-like particle vaccine (GARDASIL) (n = 509) or placebo (n = 512). Participants underwent regular gynecological examinations, cervicovaginal sampling for HPV DNA, testing for serum neutralizing antibodies to HPV and Papanicolau testing. The primary end-point was the combined incidence of persistent infection with HPV types 6, 11, 16 or 18 and cervical or external genital disease (i.e. cervical intraepithelial neoplasia, cervical cancer or external genital lesions related to HPV 6, 11, 16 or 18. Primary analyses were done per protocol. Combined incidence of persistent infection or disease with HPV 6, 11, 16 or 18 fell by 87.6% (95% confidence interval [CI], 59.2-97.6; P < 0.001), with HPV 6 or 11 by 73.1% (95% CI, -1.1-97.3; P = 0.0756) and with HPV 16 or 18 by 94.5% (95% CI, 65.2-99.9; P < 0.001) in those assigned vaccine compared with those assigned placebo. The median duration of follow up after month 7 in subjects was 23 months. In addition, the vaccine was well tolerated in Japanese women aged 18-26 years. Quadrivalent HPV vaccine could significantly reduce the acquisition of infection and clinical disease caused by HPV types 6, 11, 16 and 18.",2013,"Quadrivalent HPV vaccine could significantly reduce the acquisition of infection and clinical disease caused by HPV types 6, 11, 16 and 18.","['Japanese women aged 18-26\xa0years', 'human papillomavirus (HPV) types most frequently associated with cervical cancer (types 16/18) and genital warts (types 6/11) in Japanese women aged 18-26\xa0years']","['placebo', 'quadrivalent HPV (types 6/11/16/18) L1 virus-like particle vaccine (GARDASIL) (n\xa0=\xa0509) or placebo', 'vaccine', 'regular gynecological examinations, cervicovaginal sampling for HPV DNA', 'quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine', 'prophylactic quadrivalent vaccine', 'Quadrivalent HPV vaccine']","['median duration', 'cervical or external genital disease (i.e. cervical intraepithelial neoplasia, cervical cancer or external genital lesions', 'acquisition of infection and clinical disease']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0009663', 'cui_str': 'Warts, Venereal'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C2936379', 'cui_str': 'Vaccines, Virus-Like Particle'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0200044', 'cui_str': 'Gynecological Exam'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1960442', 'cui_str': 'Type 6 (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",512.0,0.392813,"Quadrivalent HPV vaccine could significantly reduce the acquisition of infection and clinical disease caused by HPV types 6, 11, 16 and 18.","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ebihara', 'Affiliation': ''}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Kiichiro', 'Initials': 'K', 'LastName': 'Noda', 'Affiliation': ''}]",Cancer science,['10.1111/cas.12106']
899,32422685,A randomized clinical trial of a group cognitive-behavioral therapy to reduce alcohol use among human immunodeficiency virus-infected outpatients in western Kenya.,"BACKGROUND AND AIMS


Culturally relevant and feasible interventions are needed to address limited professional resources in sub-Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive-behavioral therapy (CBT) intervention to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya.
DESIGN


Randomized clinical trial.
SETTING


A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration.
PARTICIPANTS


A total of 614 HIV-infected outpatients [312 CBT; 302 healthy life-styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking.
INTERVENTION AND COMPARATOR


A culturally adapted six-session gender-stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90-minute sessions with a 9-month follow-up.
MEASUREMENTS


Primary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time-line follow-back from baseline to 9 months post-intervention. Exploratory analyses examined unprotected sex and number of partners.
FINDINGS


Median attendance was six sessions across condition. Retention at 9 months post-intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD - CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 - 4.04; DDD - CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 - 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
CONCLUSIONS


A cognitive-behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV-infected Kenyan outpatient drinkers.",2020,"Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
","['A total of 614 HIV-infected outpatients (312 CBT; 302 HL; 48.5% male; mean age: 38.9 years; mean education 7.7 years) who reported a minimum of hazardous or binge drinking', 'HIV-infected Kenyan outpatient drinkers', 'HIV-infected outpatients in Eldoret, Kenya', 'A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration', 'human immunodeficiency virus-infected out-patients in western Kenya']","['CBT intervention compared with Healthy Lifestyles education (HL', 'cognitive-behavioral therapy intervention', 'cognitive-behavioral therapy (CBT) intervention', 'group cognitive-behavioral therapy']","['Risky sex', 'PDD and DDD marginal means', 'percent drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the Timeline Followback']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}]",614.0,0.0372522,"Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up.
","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Papas', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Benson N', 'Initials': 'BN', 'LastName': 'Gakinya', 'Affiliation': 'School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Mwaniki', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Keter', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Klein', 'Affiliation': 'Right Response LLC, Minneapolis, MN, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Loxley', 'Affiliation': 'Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Sidle', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Schlaudt', 'Affiliation': 'Lutheran World Foundation, Gore, Chad.'}, {'ForeName': 'Tobista', 'Initials': 'T', 'LastName': 'Nafula', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Omodi', 'Affiliation': 'Academic Model providing Access to Healthcare (AMPATH), Eldoret, Kenya.'}, {'ForeName': 'Joyce B', 'Initials': 'JB', 'LastName': 'Baliddawa', 'Affiliation': 'School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Kinyanjui', 'Affiliation': 'School of Medicine, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15112']
900,22962858,Cost-effectiveness of a tailored intervention designed to increase breast cancer screening among a non-adherent population: a randomized controlled trial.,"BACKGROUND


Although the percentage of women who initiate breast cancer screening is rising, the rate of continued adherence is poor. The purpose of this study was to examine the effectiveness and cost-effectiveness of a tailored print intervention compared with a non-tailored print intervention for increasing the breast cancer screening rate among a non-adherent population.
METHODS


In total, 1859 participants aged 51-59 years (except those aged 55 years) were recruited from a Japanese urban community setting. Participants were randomly assigned to receive either a tailored print reminder (tailored intervention group) or non-tailored print reminder (non-tailored intervention group). The primary outcome was improvement in the breast cancer screening rate. The screening rates and cost-effectiveness were examined for each treatment group (tailored vs. non-tailored) and each intervention subgroup during a follow-up period of five months. All analyses followed the intention-to-treat principle.
RESULTS


The number of women who underwent a screening mammogram following the reminder was 277 (19.9%) in the tailored reminder group and 27 (5.8%) in the non-tailored reminder group. A logistic regression model revealed that the odds of a woman who received a tailored print reminder undergoing mammography was 4.02 times those of a women who had received a non-tailored print reminder (95% confidence interval, 2.67-6.06). The cost of one mammography screening increase was 2,544 JPY or 30 USD in the tailored intervention group and 4,366 JPY or 52 USD in the non-tailored intervention group.
CONCLUSIONS


Providing a tailored print reminder was an effective and cost-effective strategy for improving breast cancer screening rates among non-adherent women.",2012,Participants were randomly assigned to receive either a tailored print reminder (tailored intervention group) or non-tailored print reminder (non-tailored intervention group).,"['a non-adherent population', 'women who initiate breast cancer screening', 'non-adherent women', '1859 participants aged 51-59 years (except those aged 55 years) were recruited from a Japanese urban community setting']","['tailored print intervention compared with a non-tailored print intervention', 'tailored print reminder (tailored intervention group) or non-tailored print reminder (non-tailored intervention group']","['breast cancer screening rate', 'Cost-effectiveness', 'breast cancer screening', 'breast cancer screening rates', 'screening rates and cost-effectiveness', 'effectiveness and cost-effectiveness']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",1859.0,0.0354254,Participants were randomly assigned to receive either a tailored print reminder (tailored intervention group) or non-tailored print reminder (non-tailored intervention group).,"[{'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Public Health, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fukuyoshi', 'Affiliation': ''}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Yonekura', 'Affiliation': ''}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': ''}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Seki', 'Affiliation': ''}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibuya', 'Affiliation': ''}, {'ForeName': 'Yosikazu', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': ''}]",BMC public health,['10.1186/1471-2458-12-760']
901,23892826,Designing and evaluating culturally specific smoking cessation interventions for American Indian communities.,"INTRODUCTION


American Indians have the highest smoking rates in the United States, yet few randomized controlled trials of culturally specific interventions exist. This study assessed American Indians' opinions about evidence-based treatment and attitudes toward participating in clinical trials.
METHODS


Six focus groups were conducted based on smoking status (current/former smoker), sex, and elder status (55 years and older or younger). Meetings were held at local American Indian community organizations. This project was accomplished in partnership with the American Indian Community Tobacco Projects, a community-academic research partnership at the University of Minnesota. Thematic qualitative data analyses were conducted.
RESULTS


Participants desired the following: (a) programs led by trained American Indian community members, (b) the opportunity to connect with other American Indian smokers interested in quitting, and (c) programs promoting healthy lifestyles. Strategies desired for treatment included (a) free pharmacotherapy, including nicotine replacement therapy (NRT); (b) nominal incentives, e.g., gift cards for groceries; and (c) culturally specific program components such as American Indian images, education on traditional tobacco use, and quit-smoking messages that target the value of family and include narratives or story telling in recruitment and program materials. Biochemical verification of smoking abstinence, such as salivary cotinine or carbon monoxide breathalyzers, is likely acceptable. Standard treatment or delayed treatment control groups were viewed as potentially acceptable for randomized study designs.
CONCLUSIONS


Rigorously conducted randomized controlled trials of culturally specific smoking cessation interventions are sorely needed but will only be accomplished with the commitment of funders, researchers, and collaborative trusting relationships with the community.",2014,"METHODS


Six focus groups were conducted based on smoking status (current/former smoker), sex, and elder status (55 years and older or younger).","['partnership with the American Indian Community Tobacco Projects, a community-academic research partnership at the University of Minnesota', 'Six focus groups were conducted based on smoking status (current/former smoker), sex, and elder status (55 years and older or younger', 'American Indian communities', 'Participants desired the following: (a) programs led by trained American Indian community members, (b) the opportunity to connect with other American Indian smokers interested in quitting, and (c) programs promoting healthy lifestyles']","['nicotine replacement therapy (NRT); (b) nominal incentives, e.g., gift cards for groceries; and (c) culturally specific program components such as American Indian images, education on traditional tobacco use, and quit-smoking messages that target the value of family and include narratives or story telling in recruitment and program materials', 'culturally specific smoking cessation interventions']",[],"[{'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0035168'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1136188', 'cui_str': 'Gifts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",[],,0.0206889,"METHODS


Six focus groups were conducted based on smoking status (current/former smoker), sex, and elder status (55 years and older or younger).","[{'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Chronic Disease Outcomes Research (CCDOR), Minneapolis VA Health Care System, Minneapolis, MN;'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Widome', 'Affiliation': ''}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Forster', 'Affiliation': ''}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Joseph', 'Affiliation': ''}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntt111']
902,23763511,Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805).,"The oral fluoropyrimidine, S-1, combined with or without gemcitabine is considered to be a promising agent for treating advanced biliary tract cancer; gemcitabine plus cisplatin is the current standard regimen. This randomized phase II trial was designed to evaluate the safety and efficacy of two regimens: gemcitabine plus S-1 (GS) (gemcitabine: 1000 mg/m(2) , day 1 and day 8; S-1: 60 mg/m(2) , twice daily on days 1-14, repeated every 3 weeks); and S-1 (80 mg/m(2) , days 1-28, given orally twice daily for 4 weeks, followed by a 2-week rest, repeated every 6 weeks). The regimen with a higher 1-year survival would be selected for a subsequent phase III trial. Between February 2009 and April 2010, 101 patients were randomized. For the GS (n = 51) and S-1 (n = 50) arms, the 1-year survival was 52.9% (95% confidence interval, 38.5-65.5) and 40.0% (95% confidence interval, 26.5-53.1), and the median survival times were 12.5 and 9.0 months, respectively. Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%). Although two treatment-related deaths occurred in the GS arm, all other grade 3/4 non-hematological toxicities were reversible. In conclusion, GS was considered to be more promising and was selected as the test regimen for a subsequent phase III trial comparing GS with gemcitabine plus cisplatin combination therapy. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001685 (http://www.umin.ac.jp/ctr/index.htm).",2013,"Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%).","['advanced biliary tract cancer', 'Between February 2009 and April 2010, 101 patients were randomized']","['gemcitabine plus S-1 (GS) (gemcitabine', 'gemcitabine plus S-1 versus S-1', 'fluoropyrimidine, S-1, combined with or without gemcitabine', 'gemcitabine plus cisplatin combination therapy', 'gemcitabine plus cisplatin']","['deaths', '1-year survival', 'Grade 3/4 hematological toxicities', 'median survival times', 'safety and efficacy', 'hematological toxicities']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",101.0,0.104088,"Grade 3/4 hematological toxicities were more frequent in the GS arm (leucocytes 29.4%, neutrophils 60.8%, hemoglobin 11.8%, platelets 11.8%) than in the S-1 arm (leucocytes 2.0%, neutrophils 4.0%, hemoglobin 4.0%, platelets 4.0%).","[{'ForeName': 'Chigusa', 'Initials': 'C', 'LastName': 'Morizane', 'Affiliation': 'Hepatobiliary and Pancreatic Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': ''}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': ''}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Takashima', 'Affiliation': ''}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': ''}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': ''}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hamamoto', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': ''}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': ''}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': ''}]",Cancer science,['10.1111/cas.12218']
903,32493111,A randomized controlled trial of dorsal web space versus palmar midline injection of steroid in the treatment of trigger digits.,"One hundred and sixty patients were enrolled in a prospective randomized controlled trial to assess whether a steroid injection through the dorsal web space was less painful than the palmar midline technique in the treatment of trigger digits and whether they were equally effective. There were 116 women and 44 men with a mean age of 60 years. The mean visual analogue score for pain during the injection was 3.6 in the dorsal web space group and 5.4 in the palmar midline group on a scale of 0-10. The overall success of treatment in the dorsal group was 67%, whereas it was 56% in the palmar group. No complications were noted. We concluded from this study that the dorsal web space technique is less painful and at least as effective as the palmar midline technique. Level of evidence:  I.",2020,"The overall success of treatment in the dorsal group was 67%, whereas it was 56% in the palmar group.","['One hundred and sixty patients', '116 women and 44 men with a mean age of 60 years', 'trigger digits']","['dorsal web space versus palmar midline injection of steroid', 'steroid injection']","['mean visual analogue score for pain', 'overall success']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",160.0,0.0543586,"The overall success of treatment in the dorsal group was 67%, whereas it was 56% in the palmar group.","[{'ForeName': 'Isidro', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Gerardo L', 'Initials': 'GL', 'LastName': 'Garcés', 'Affiliation': 'School of Medicine. Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Marcos-García', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Medina', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420927999']
904,22587416,"Aurora-A activation, correlated with hypoxia-inducible factor-1α, promotes radiochemoresistance and predicts poor outcome for nasopharyngeal carcinoma.","Previously, we and others showed that hypoxia-inducible factor-1α (HIF-1α) and transcriptionally upregulated Aurora-A were required for disease progression in several tumors. Here, we address the clinicopathologic value of Aurora-A and HIF-1α in locally advanced nasopharyngeal carcinoma (NPC). Aurora-A and HIF-1α expression was semiquantitatively evaluated by immunohistochemistry staining in 144 cases from a randomized controlled trial. Of these patients, 69 received neoadjuvant chemotherapy plus concurrent chemoradiotherapy, and acted as the training set, and 75 cases treated with neoadjuvant chemotherapy plus radiotherapy were used as the testing set to validate the prognostic effect of Aurora-A and HIF-1α. We found that Aurora-A and HIF-1α were highly expressed in NPC, but were deficient in normal adjacent epithelia. In the testing set, Aurora-A overexpression predicted a shortened 5-year overall survival (59.1% vs 82.5%, P = 0.024), progression-free survival (44.8% vs 79.8%, P = 0.004), and distant metastasis-free survival (43.0% vs 17.3%, P = 0.016). Multivariate regression analysis confirmed that Aurora-A was indeed an independent prognostic factor for death, recurrence, and distant metastasis both in the testing set and overall patients. Moreover, a positive correlation between Aurora-A and HIF-1α was detected (P = 0.037). Importantly, although HIF-1α did not show any prognostic effect for patient outcome, the subset with Aurora-A and HIF-1α co-overexpression had the poorest overall, progression-free, and distant metastasis-free survival (all P < 0.05). Our results confirmed that Aurora-A was an independent prognostic factor for NPC. Aurora-A combined with HIF-1α refined the risk definition of the patient subset, thus potentially directing locally advanced NPC patients for more selective therapy.",2012,"Multivariate regression analysis confirmed that Aurora-A was indeed an independent prognostic factor for death, recurrence, and distant metastasis both in the testing set and overall patients.",['locally advanced nasopharyngeal carcinoma (NPC'],"['neoadjuvant chemotherapy plus radiotherapy', 'neoadjuvant chemotherapy plus concurrent chemoradiotherapy']","['hypoxia-inducible factor-1α (HIF-1α', 'progression-free, and distant metastasis-free survival', 'positive correlation between Aurora-A and HIF-1α', 'progression-free survival', 'Aurora-A and HIF-1α expression', 'prognostic factor for death, recurrence, and distant metastasis', 'distant metastasis-free survival', '5-year overall survival']","[{'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma (disorder)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",144.0,0.0812761,"Multivariate regression analysis confirmed that Aurora-A was indeed an independent prognostic factor for death, recurrence, and distant metastasis both in the testing set and overall patients.","[{'ForeName': 'Xiang-Bo', 'Initials': 'XB', 'LastName': 'Wan', 'Affiliation': 'Department of Medical Oncology, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xin-Juan', 'Initials': 'XJ', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ming-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei-Hua', 'Initials': 'WH', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yan-Chun', 'Initials': 'YC', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Xiang-Yuan', 'Initials': 'XY', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Ming-Huang', 'Initials': 'MH', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ''}]",Cancer science,['10.1111/j.1349-7006.2012.02332.x']
905,30828188,Early versus delayed mobilization following rotator cuff repair.,"Rotator cuff tears are a common cause for pain and reduced function. Tears of the tendons of the cuff can be a result of a degenerative process or as a consequence of trauma. Management of cuff tears are surrounded by controversy from indications for surgical management to rehabilitation protocol post-surgical repair. The aim of post surgical rehabilitation is to improve functional outcome, reduce pain and promote tendon healing. In the case of rotator cuff repair, rehabilitation can be broadly divided into early passive range of motion (EPM) and delayed range of motion (DRM). The EPM regime is defined by minimal immobilisation of the shoulder and passive mobilisation of the joint within the first post-operative period. In contrast, DRM immobilises the shoulder joint up to six weeks post-operatively. Proponents of EPM state various advantages of their rehabilitation protocol including improved range of motion and earlier return to normal activities of daily living. However, there has also been concern that this rehabilitation regime may result in an increased rate of re-rupture. Since this is a highly controversial issue, various high quality literature have been published looking to clarify which regime is best following rotator cuff surgery. Reviewing these articles, it appears that there is an increase rate of re-tear of the repaired rotator cuff tendon when the EPM regime is employed. Statistical significance however was limited by small sample sizes. Range of motion post-repair also appears to be associated with post-operative rehabilitation regime. As expected, the EPM regime has been shown to improve range of motion post-repair. Despite this, literature reports patients managed with the DPM showed a statistically better patient reported outcome measure. We conclude that based on the evidence we currently have, early range of motion post rotator cuff repair is related with an increase risk of re-tear. The DPM regime reduces this risk with the possible complication of reduced range of shoulder movement. This problem is thought to be an easier clinical issue to deal with compared to re-rupture of the repaired rotator cuff tendon. There is however lack of data to achieve statistical significance in most of these analysis. There is a definite need for a large, multi-centre single blinded randomised controlled trial to further shed light on this controversial topic.",2019,Proponents of EPM state various advantages of their rehabilitation protocol including improved range of motion and earlier return to normal activities of daily living.,[],[],"['rate of re-rupture', 'range of motion and earlier return to normal activities of daily living', 'functional outcome, reduce pain and promote tendon healing']",[],[],"[{'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]",,0.0597856,Proponents of EPM state various advantages of their rehabilitation protocol including improved range of motion and earlier return to normal activities of daily living.,"[{'ForeName': 'Nik', 'Initials': 'N', 'LastName': 'Bakti', 'Affiliation': 'Department of Trauma & Orthopaedics, Medway NHS Foundation Trust, Windmill Road, Gillingham, Kent, ME7 5NY, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Antonios', 'Affiliation': ""Department of Trauma & Orthopaedics, Guy's & St Thomas' NHS Foundation Trust, Great Maze Pond, London, SE1 9RT, UK.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Phadke', 'Affiliation': 'Department of Trauma & Orthopaedics, Medway NHS Foundation Trust, Windmill Road, Gillingham, Kent, ME7 5NY, UK.'}, {'ForeName': 'Bijayendra', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Trauma & Orthopaedics, Medway NHS Foundation Trust, Windmill Road, Gillingham, Kent, ME7 5NY, UK.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2019.01.016']
906,31539295,Negative Hyperselection of Patients With  RAS  and  BRAF  Wild-Type Metastatic Colorectal Cancer Who Received Panitumumab-Based Maintenance Therapy.,"PURPOSE


We assessed the prognostic/predictive role of primary tumor sidedness and uncommon alterations of anti-epidermal growth factor receptor (EGFR) primary resistance (primary resistance in  RAS  and  BRAF  wild-type metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with  RAS / BRAF  wild-type (wt) metastatic colorectal cancer (mCRC) who were randomly assigned to panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino trial (ClinicalTrials.gov identifier: NCT02476045).
PATIENTS AND METHODS


This prespecified retrospective analysis included 199 evaluable patients with  RAS / BRAF  wt. The PRESSING panel included the following: immunohistochemistry (IHC) and in situ hybridization for  HER2/MET  amplification, IHC with or without RNA sequencing for  ALK/ROS1/NTRKs/RET  fusions, next-generation sequencing for  HER2 / PIK3CAex.20/PTEN / AKT1  and  RAS  mutations with low mutant allele fraction, and multiplex polymerase chain reaction for microsatellite instability. PRESSING status (any positive biomarker  v  all negative) and sidedness were correlated with overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) in the study population and by treatment arm.
RESULTS


Overall, left- and right-sided tumors were 85.4% and 14.6%, respectively, and PRESSING-negative and -positive tumors were 75.4% and 24.6%, respectively. At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062). Similar results were observed in the PRESSING-positive versus PRESSING-negative subgroup for ORR (59.2%  v  75.3%;  P  = .030), PFS (7.7  v  12.1 months;  P  < .001), and OS (2-year rate: 48.1%  v  68.1%;  P  = .021). The PFS benefit of FU plus LV added to panitumumab maintenance, reported in the study, was independent from sidedness and PRESSING status (interaction for PFS  P  = .293 and .127, respectively). However, outcomes were extremely poor in patients who received single-agent panitumumab and had right-sided tumors (median PFS, 7.7 months; 2-year OS, 38.5%) or PRESSING-positive tumors (median PFS, 7.4 months; 2-year OS, 47.0%).
CONCLUSION


The combined assessment of sidedness and molecular alterations of anti-EGFR primary resistance identified a consistent proportion of patients with  RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs.",2019,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062).","['199 evaluable patients with  RAS / BRAF  wt', 'Patients With  RAS  and  BRAF  Wild-Type Metastatic Colorectal Cancer', 'patients with  RAS / BRAF -wt mCRC who had inferior benefit from initial anti-EGFR-based regimens, particularly after maintenance with single-agent anti-EGFRs', 'metastatic colorectal cancer patients treated with anti-EGFR monoclonal antibodies [PRESSING] panel) in patients with  RAS / BRAF  wild-type (wt) metastatic colorectal cancer (mCRC']","['Panitumumab-Based Maintenance Therapy', 'panitumumab plus fluorouracil, leucovorin, and oxaliplatin (FOLFOX-4) induction followed by maintenance with panitumumab with or without fluorouracil (FU) plus leucovorin (LV); Valentino']","['Overall, left- and right-sided tumors', 'overall response rate (ORR), progression-free survival (PFS), and overall survival (OS', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",199.0,0.168706,"At a median follow-up of 26 months, inferior outcomes were consistently observed in right- versus left-sided tumors for ORR (55.2%  v  74.1%;  P  = .037), PFS (8.4  v  11.5 months;  P  = .026), and OS (2-year rate: 50.2%  v  65.1%;  P  = .062).","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'University of Pisa, Pisa, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Humanitas Cancer Center, IRCCS, Rozzano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Murialdo', 'Affiliation': 'University of Genoa and IRCCS Azienda Ospedaliera Universitaria (AOU) San Martino-IST, Genoa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sartore-Bianchi', 'Affiliation': 'Niguarda Cancer Center, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Azienda Socio-Sanitaria Territoriale Ospedale di Cremona, Cremona, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Racca', 'Affiliation': 'AOU Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Adamo', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Gloghini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Busico', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palermo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milione', 'Affiliation': 'Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Fondazione Instituto di Ricovero e Cura Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01254']
907,32423348,Associations Between Dietary Patterns and Subclinical Cardiac Injury: An Observational Analysis From the DASH Trial.,"BACKGROUND


The DASH diet has been found to lower blood pressure (BP) and low-density lipoprotein cholesterol levels.
OBJECTIVE


To compare diets rich in fruits and vegetables with a typical American diet in their effects on cardiovascular injury in middle-aged adults without known preexisting cardiovascular disease (CVD).
DESIGN


Observational study based on a 3-group, parallel-design, randomized trial conducted in the United States from 1994 to 1996. (ClinicalTrials.gov: NCT00000544).
SETTING


3 of the 4 original clinical trial centers.
PARTICIPANTS


326 of the original 459 trial participants with available stored specimens.
INTERVENTION


Participants were randomly assigned to 8 weeks of monitored feeding with a control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet, which is rich in fruits, vegetables, low-fat dairy, and fiber and has low levels of saturated fat and cholesterol. Weight was kept constant throughout feeding.
MEASUREMENTS


Biomarkers collected at baseline and 8 weeks: high-sensitivity cardiac troponin I (hs-cTnI),  N -terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity C-reactive protein (hs-CRP).
RESULTS


The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg. Compared with the control diet, the fruit-and-vegetable diet reduced hs-cTnI levels by 0.5 ng/L (95% CI, -0.9 to -0.2 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.1 pg/mL). Compared with the control diet, the DASH diet reduced hs-cTnI levels by 0.5 ng/L (CI, -0.9 to -0.1 ng/L) and NT-proBNP levels by 0.3 pg/mL (CI, -0.5 to -0.04 pg/mL). Levels of hs-CRP did not differ among diets. None of the markers differed between the fruit-and-vegetable and DASH diets.
LIMITATION


Short duration, missing specimens, and an inability to isolate the effects of specific foods or micronutrients.
CONCLUSION


Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
PRIMARY FUNDING SOURCE


National Institutes of Health, National Heart, Lung, and Blood Institute.",2020,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","['middle-aged adults without known preexisting cardiovascular disease (CVD', '3 of the 4 original clinical trial centers', '326 of the original 459 trial participants with available stored specimens', 'United States from 1994 to 1996', 'The mean age of participants was 45.2 years, 48% were women, 49% were black, and mean baseline BP was 131/85 mm Hg', 'adults without preexisting CVD']","['diets rich in fruits and vegetables with a typical American diet', 'control diet typical of what many Americans eat; a diet rich in fruits and vegetables but otherwise similar to the control diet; or the DASH diet']","['blood pressure (BP) and low-density lipoprotein cholesterol levels', 'cardiovascular injury', 'NT-proBNP levels', 'hs-cTnI levels', 'Weight', 'Levels of hs-CRP', 'high-sensitivity cardiac troponin']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0560570', 'cui_str': 'Cardiovascular injury'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]",,0.0964925,"Diets rich in fruits and vegetables given over 8 weeks were associated with lower levels of markers for subclinical cardiac damage and strain in adults without preexisting CVD.
","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Kovell', 'Affiliation': 'University of Massachusetts Medical School, Worcester, Massachusetts (L.C.K.).'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland (L.J.A., E.R.M.).'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts (F.M.S.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Christenson', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rebuck', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., H.R.).'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Chang', 'Affiliation': 'Geisinger Health System, Danville, Pennsylvania (A.R.C.).'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (S.P.J., K.J.M.).'}]",Annals of internal medicine,['10.7326/M20-0336']
908,32423577,"Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial.","BACKGROUND


Blood flow restriction (BFR) training with low weight is purported to induce similar physiological changes to high-weight regimens with the benefit of less tissue stress. We hypothesized that low-weight training with BFR would produce increased gains in strength and hypertrophy for muscle groups proximal, distal, and contralateral to tourniquet placement compared with low-weight training alone.
METHODS


In this prospective, randomized controlled trial, healthy subjects were randomized into a 6-week low-weight training program either with or without BFR on 1 extremity. Outcome measures included limb circumference and strength. Comparisons were made between the BFR and non-BFR extremities, BFR and control groups, and non-BFR extremity and control groups.
RESULTS


A total of 24 subjects (14 BFR and 10 control subjects) completed the protocol. Significantly greater gains were observed in dynamometric strength both proximal (shoulder scaption [30% greater], flexion [23%], and abduction [22%]) and distal (grip strength [13%]) to the tourniquet in the BFR limb compared with both the non-BFR extremity and the control group (P < .05). Arm and forearm circumferences significantly increased in the BFR limb compared with the non-BFR limb and control group (P = .01). The non-BFR extremity demonstrated greater grip strength than the control group (9%, P < .01). No adverse events were reported.
CONCLUSION


Low-weight BFR training provided a greater increase in strength and hypertrophy in the upper-extremity proximal and distal muscle groups compared with the control group. The non-BFR extremity showed a significant increase in grip strength compared with the control group, indicating a potential systemic effect.",2020,Arm and forearm circumferences significantly increased in the BFR limb compared with the non-BFR limb and control group (P = .01).,"['healthy subjects', '24 subjects (14 BFR and 10 control subjects']","['Low-weight BFR training', 'Blood flow restriction (BFR) training', 'low-weight training program either with or without BFR']","['forearm circumferences', 'gains in strength and hypertrophy', 'strength and hypertrophy', 'grip strength', 'adverse events', 'limb circumference and strength', 'dynamometric strength both proximal (shoulder scaption', 'BFR limb']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",24.0,0.0270852,Arm and forearm circumferences significantly increased in the BFR limb compared with the non-BFR limb and control group (P = .01).,"[{'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Bowman', 'Affiliation': 'Department of Orthopaedics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Eric.N.Bowman@vumc.org.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Elshaar', 'Affiliation': 'Rochester Regional Health Orthopaedics, Pittsford, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Milligan', 'Affiliation': 'Elite OrthoSport Physical Therapy, Los Angeles, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Jue', 'Affiliation': 'Select Physical Therapy, Los Angeles, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mohr', 'Affiliation': 'Kerlan Jobe Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Patty Brown Physical Therapy & Associates, El Segundo, CA, USA.'}, {'ForeName': 'Drew M', 'Initials': 'DM', 'LastName': 'Watanabe', 'Affiliation': 'Kerlan Jobe Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Orr', 'Initials': 'O', 'LastName': 'Limpisvasti', 'Affiliation': 'Kerlan Jobe Institute, Los Angeles, CA, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.02.003']
909,31540737,"Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty.","BACKGROUND


The aim of our prospective, multicenter, randomized, controlled trial (titled M2A-38 Ceramic-on-Metal RCT, NCT00754520) is to demonstrate noninferiority of a ceramic-on-metal (CoM) articulation compared with metal-on-metal (MoM) in total hip arthroplasty. The study arms are at 8 years since implantation, with metal ion and functional score analysis at 5 years.
METHODS


We recruited 211 patients between 2009 and 2011. The patients were randomized to ceramic or metal. A cohort of these patients had whole blood metal ions performed yearly, and all patients underwent annual radiographic and clinical outcome assessment. All revisions were recorded and some explants were analyzed. Recruitment ceased earlier than planned owing to concerns raised with failure of MoM implants.
RESULTS


No significant difference was seen in patient demographics, radiographic parameters, or functional outcomes at any time point. Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points. Chromium levels were significantly lower in the CoM group up to 3 years, but raised at 5 years. There were slightly fewer revisions for adverse reaction to metal debris in the CoM group. Explant analysis suggested a different wear pattern to those seen in the MoM group.
CONCLUSION


The results demonstrated that the CoM articulation behaved the same as the MoM in terms of functional outcome and radiographic parameters. The CoM coupling also demonstrates raised metal ions beyond 3 years and increasing revisions for adverse reaction to metal debris. It remains difficult to see a clinical application for CoM and further exploration or use is not warranted.",2020,Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points.,"['Total Hip Arthroplasty', '211 patients between 2009 and 2011', 'total hip arthroplasty']","['metal-on-metal (MoM', 'ceramic or metal', 'Metal-on-Metal With Ceramic']","['Lower cobalt ion levels', 'patient demographics, radiographic parameters, or functional outcomes', 'Chromium levels', 'adverse reaction to metal debris']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0440266', 'cui_str': 'Debris (substance)'}]",211.0,0.095467,Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points.,"[{'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Higgins', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Conn', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Britton', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Pesola', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Central Finland Central Hospital, Jyvaskyla, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Manninen', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Kymenlaakso Central Hospital, Kotka, Finland.'}, {'ForeName': 'Geoff J', 'Initials': 'GJ', 'LastName': 'Stranks', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.002']
910,31587982,"Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND


Pain after total knee arthroplasty (TKA) affects postoperative recovery and patient satisfaction. The analgesic benefits of corticosteroids have not been well studied. We, therefore, investigated the analgesic effects of intravenous (IV) dexamethasone (DEX) in patients undergoing a TKA.
METHODS


This was a randomized, double-blind, placebo-controlled trial of 0.15 mg/kg of IV DEX vs saline placebo in unilateral TKA. Fifty patients/arm were recruited. Primary outcomes were pain level, determined by a visual analog scale, and the amount of morphine consumption (mg) ≤48 hours post-TKA. Secondary outcomes were rates of nausea and vomiting, C-reactive protein concentrations, and functional outcomes.
RESULTS


The DEX group had a significantly lower mean visual analog scale score both at rest and during motion at 12, 15, 18, and 21 hours (P < .05). At 21 hours, the mean difference (Δ) in pain at rest was -11 points (95% confidence interval [CI], -21 to -2 points; P = .02) while the mean difference in pain during motion was -15 points (95% CI, -25 to -5 points; P = .004). The DEX group also had lower rates of nausea and vomiting: 29/50 (58%) vs 42/50 (84%) (P = .008) and lower mean C-reactive protein level: 89 vs 167, Δ = -78 mg/L (95% CI, -100 to -58 mg/L, P < .0001). There were no significant differences in mean morphine consumption by 48 hours, modified Western Ontario and McMaster University Osteoarthritis Index scores, and range of motion of the knee at 3-month follow-up (P > .05).
CONCLUSION


IV DEX relieves postoperative pain between 12 to 21 hours after TKA and may be a useful adjunct for controlling pain in patients undergoing TKA.",2020,"There were no significant differences in mean morphine consumption by 48 hours, modified Western Ontario and McMaster University Osteoarthritis Index scores, and range of motion of the knee at 3-month follow-up (P > .05).
","['Fifty patients/arm were recruited', 'After Total Knee Arthroplasty', 'unilateral TKA', 'patients undergoing TKA', 'patients undergoing a TKA']","['Placebo', 'IV DEX vs saline placebo', 'corticosteroids', 'placebo', 'Intravenous Dexamethasone Injection', 'IV DEX', 'total knee arthroplasty (TKA', 'DEX', 'intravenous (IV) dexamethasone (DEX']","['postoperative pain', 'nausea and vomiting', 'pain during motion', 'rates of nausea and vomiting, C-reactive protein concentrations, and functional outcomes', 'mean morphine consumption by 48\xa0hours, modified Western Ontario and McMaster University Osteoarthritis Index scores, and range of motion of the knee', 'pain', 'mean visual analog scale score', 'Pain', 'pain level, determined by a visual analog scale, and the amount of morphine consumption (mg) ≤48\xa0hours post-TKA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4692162', 'cui_str': 'Dexamethasone Injection [Dexycu]'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",50.0,0.806834,"There were no significant differences in mean morphine consumption by 48 hours, modified Western Ontario and McMaster University Osteoarthritis Index scores, and range of motion of the knee at 3-month follow-up (P > .05).
","[{'ForeName': 'Nattapol', 'Initials': 'N', 'LastName': 'Tammachote', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Thammasat University, Khlong Luang, Pathumthani, Thailand.'}, {'ForeName': 'Supakit', 'Initials': 'S', 'LastName': 'Kanitnate', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Thammasat University, Khlong Luang, Pathumthani, Thailand.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.09.002']
911,31537375,Dilute Povidone-Iodine Solution Prevents Intraoperative Contamination of Sterile Water Basins During Total Joint Arthroplasty.,"BACKGROUND


Periprosthetic joint infection is a major complication of total joint arthroplasty (TJA). The intraoperative splash basin has been found to be a potential source of contamination. Although consensus recommendations against the use of splash basin have been made, splash basin use continues to be taught and utilized in practice. This study aims to investigate the effect of dilute betadine addition to the sterile water (SW) contents (0.02% solution) of the splash basin on contamination rates. This intervention could preserve the functionality and preferential use of the splash basin. The primary outcome of this study is the rate of splash basin contamination, with secondary outcomes of prevalence of culture speciation and mean operative times association with the rate of positive cultures.
METHODS


Patients undergoing primary TJA were enrolled in a randomized controlled trial with assignment to either the intervention/betadine group, in which dilute betadine was added to the standard SW splash basin, or the control/standard SW group. For a total cohort of 104 patients, a 120 mL aliquot sample of basin fluid was collected at incision (""preprocedure"") and closure (""postprocedure""). Samples were cultured and monitored for 48 hours for growth, with further testing as necessary to identify microbial speciation.
RESULTS


Of the final 100 postprocedure samples, 0 (0.0%) were positive in the betadine group, while there were 23 (47.9%) positive samples in the SW group (P < .001). Of the positive cultures, the most common species grown were coagulase-negative Staphylococcus, Corynebacterium, and Micrococcus. The mean operative time was an average of 11 minutes longer for cases with positive cultures.
CONCLUSION


In conclusion, treating SW splash basins with dilute povidone-iodine (0.02% solution) eliminates intraoperative contamination of splash basins in TJA procedures. This intervention is simple, low cost, and readily implementable, making it a reasonable addition to TJA protocols.
LEVEL OF EVIDENCE


Level 1, Controlled Laboratory Study.",2020,"The mean operative time was an average of 11 minutes longer for cases with positive cultures.
","['Patients undergoing primary TJA', '104 patients, a 120 mL aliquot sample of basin fluid was collected at incision (""preprocedure"") and closure (""postprocedure']","['dilute betadine', 'betadine', 'dilute betadine was added to the standard SW splash basin, or the control/standard SW group', 'Dilute Povidone-Iodine Solution', 'dilute povidone-iodine']","['rate of splash basin contamination, with secondary outcomes of prevalence of culture speciation and mean operative times association with the rate of positive cultures', 'Intraoperative Contamination of Sterile Water Basins', 'contamination rates', 'mean operative time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",104.0,0.101504,"The mean operative time was an average of 11 minutes longer for cases with positive cultures.
","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nazal', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Galloway', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Karanpreet K', 'Initials': 'KK', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Shields', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.016']
912,32422066,Effect of Acupuncture for Postprandial Distress Syndrome: A Randomized Clinical Trial.,"BACKGROUND


Postprandial distress syndrome (PDS) is the most common subtype of functional dyspepsia. Acupuncture is commonly used to treat PDS, but its effect is uncertain because of the poor quality of prior studies.
OBJECTIVE


To assess the efficacy of acupuncture versus sham acupuncture in patients with PDS.
DESIGN


Multicenter, 2-group, randomized clinical trial. (ISRCTN registry number: ISRCTN12511434).
SETTING


5 tertiary hospitals in China.
PARTICIPANTS


Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS.
INTERVENTION


12 sessions of acupuncture or sham acupuncture over 4 weeks.
MEASUREMENTS


The 2 primary outcomes were the response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation after 4 weeks of treatment. Participants were followed until week 16.
RESULTS


Among the 278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16. The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  P  < 0.001). The estimated elimination rate of all 3 cardinal symptoms was 27.8% in the acupuncture group versus 17.3% in the sham acupuncture group (difference, 10.5 percentage points [CI, 0.08 to 20.9 percentage points];  P  = 0.034). The efficacy of acupuncture was maintained during the 12-week posttreatment follow-up. There were no serious adverse events.
LIMITATION


Lack of objective outcomes and daily measurement, high dropout rate, and inability to blind acupuncturists.
CONCLUSION


Among patients with PDS, acupuncture resulted in increased response rate and elimination rate of all 3 cardinal symptoms compared with sham acupuncture, with sustained efficacy over 12 weeks in patients who received thrice-weekly acupuncture for 4 weeks.
PRIMARY FUNDING SOURCE


Beijing Municipal Science and Technology Commission.",2020,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  ","['5 tertiary hospitals in China', 'Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS', 'patients with PDS', 'Postprandial Distress Syndrome', '278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16']","['acupuncture', 'acupuncture versus sham acupuncture', 'acupuncture or sham acupuncture', 'Acupuncture', 'sham acupuncture']","['response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation', 'elimination rate of all 3 cardinal symptoms', 'response rate and elimination rate']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",278.0,0.617612,"The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points];  ","[{'ForeName': 'Jing-Wen', 'Initials': 'JW', 'LastName': 'Yang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Shi-Yan', 'Initials': 'SY', 'LastName': 'Yan', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China (S.Y.).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jing-Jie', 'Initials': 'JJ', 'LastName': 'Zhao', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (Y.W., J.T.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (J.W.).'}, {'ForeName': 'Guang-Xia', 'Initials': 'GX', 'LastName': 'Shi', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China (H.H.).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Huguosi Hospital of Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China (W.Z.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China (J.Z., Y.D.).'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, and Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China (C.L.).'}]",Annals of internal medicine,['10.7326/M19-2880']
913,31955233,Reductions in body sway responses to a rhythmic support surface tilt perturbation can be caused by other mechanisms than prediction.,"Studies investigating balance control often use external perturbations to probe the system. These perturbations can be administered as randomized, pseudo-randomized, or predictable sequences. As predictability of a given perturbation can affect balance performance, the way those perturbations are constructed may affect the results of the experiments. In the present study, we hypothesized that subjects are able to adapt to short, rhythmic support surface tilt stimuli, but not to long pseudo-random stimuli. 19 subjects were standing with eyes closed on a servo-controlled platform tilting about the ankle joint axis. Pre and post to the learning intervention, pseudo-random tilt sequences were applied. For the learning phase, a rhythmic and easy-to-memorize 8-s long sequence was applied 75 times, where subjects were instructed to stand as still as possible. Body kinematics were measured and whole body center of mass sway was analyzed. Results showed reduced sway and less forward lean of the body across the learning phase. The sway reductions were similar for stimulus and non-stimulus frequencies. Surprisingly, for the pseudo-random sequences, comparable changes were found from pre- to post-tests. In summary, results confirmed that considerable adaptations exist when exposing subjects to an 8-s long rhythmic perturbation. No indications of predictions of the learning tilt sequence were found, since similar changes were also observed in response to pseudo-random sequences. We conclude that changes in body sway responses following 75 repetitions of an 8-s long rhythmic tilt sequence are due to adaptations in the dynamics of the control mechanism (presumably stiffness).",2020,The sway reductions were similar for stimulus and non-stimulus frequencies.,['19 subjects were standing with eyes closed on a servo-controlled platform tilting about the ankle joint axis'],[],"['Body kinematics', 'sway reductions', 'body sway responses']","[{'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}]",[],"[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",19.0,0.0159708,The sway reductions were similar for stimulus and non-stimulus frequencies.,"[{'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Assländer', 'Affiliation': 'Human Performance Research Centre, University of Konstanz, Konstanz, Germany. lorenz.asslaender@uni-konstanz.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gruber', 'Affiliation': 'Human Performance Research Centre, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Louis-Solal', 'Initials': 'LS', 'LastName': 'Giboin', 'Affiliation': 'Human Performance Research Centre, University of Konstanz, Konstanz, Germany.'}]",Experimental brain research,['10.1007/s00221-020-05723-z']
914,31528072,Unreamed Intra-Medullary Nail Versus Half Pin External Fixator in Grade III [A & B] Open tibia fractures.,"Background


Tibia fracture is the most common long bone fracture. The fractures of tibia are commonly open fractures due to subcutaneous position of the tibia. The choice of technique for stabilization of open tibia fractures includes - External fixation, unreamed intra-medullary nails [URTN], Reamed intra-medullary nails, ORIF with Plating.
Objectives


To evaluate & compare the results of Unreamed Intra-Medullary Nail Versus Half Pin External Fixator in Grade III [A & B] Open tibia fractures.
Methods


This prospective clinical study [Randomized chit box] was done on 50 patients presenting to our institute within 24 h of injury. Only those who were skeletally mature with open tibia fracture Grade IIIA & IIIB [Gustilo-Anderson] were included in this study. After initial management, radiological assessment was done. Following this adequate wound debridement, skeletal stabilization with either primary URTN or external fixator was done. Inspection and debridement were repeated at 48-h intervals until the wound was considered clean.
Results


50 cases [25 each group] were compared in terms of - Final Alignment of the Fracture, Presence of Infection/Non-union/Mal-union, Hardware failure, Time to Bone Union, Number of Operative Procedures after index admission. Mean time to full weight bearing was 20.96 weeks in URTN group versus 24.8 weeks in Ex-fix group. 5 in URTN group required further surgery for non-union versus 11 patients in Ex-fix group. There were 6 significant pin track infection. Removal of nail was required in 1 case of deep infection.
Conclusion


This study supports the use of the URTN over External fixator in the treatment of severe open tibia fractures.",2019,Mean time to full weight bearing was 20.96 weeks in URTN group versus 24.8 weeks in Ex-fix group.,"['severe open tibia fractures', 'Only those who were skeletally mature with open tibia fracture Grade IIIA & IIIB', 'Grade III', '50 patients presenting to our institute within 24\u202fh of injury']","['Unreamed Intra-Medullary Nail Versus Half', 'External fixation, unreamed intra-medullary nails [URTN']","['Mean time to full weight bearing', 'pin track infection']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0175718', 'cui_str': 'Bone Pins'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",50.0,0.0213048,Mean time to full weight bearing was 20.96 weeks in URTN group versus 24.8 weeks in Ex-fix group.,"[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'S. M. S. Hospital, Jaipur, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Khanna', 'Affiliation': 'National Institute of Medical Sciences, Jaipur, India.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Goyal', 'Affiliation': 'S. M. S. Hospital, Jaipur, India.'}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Joshi', 'Affiliation': 'S. M. S. Hospital, Jaipur, India.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2018.10.016']
915,31591010,Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery.,"BACKGROUND


Randomized controlled trials of kinematic alignment (KA) and mechanical alignment (MA) in primary total knee arthroplasty (TKA) have to date demonstrated at least equivalence of KA in terms of clinical outcomes. No trial of bilateral TKA has been conducted so patient preference for one technique over the other is unknown.
METHODS


Forty-one participants underwent computer-assisted bilateral TKA. The outcome measures were as follows: (1) joint range of motion and functional scores including the KOOS, the KOOS JR, Oxford Knee Score, and the Forgotten Joint Score at a minimum of 2 years; (2) preference and perception of limb symmetry; (3) intraoperative alignment data; (4) release and gap balance data; and (5) postoperative radiographic joint angles.
RESULTS


There were no significant differences with respect to flexion range (P = .970) or functional scores (mean KOOS, P = .941; KOOS JR, P = .685; Oxford Knee Score, P = .578; FJS, P = .542). Significantly more participants who favored one knee preferred their KA TKA (P = .03); however, half of the patients had no preference and the overall numbers were small. Only 3 participants perceived any limb asymmetry (P < .001). More releases were required in the MA group (P = .018). Standing hip-knee-ankle angle means and frequency distributions were similar (P = .097 and P = .097, respectively).
CONCLUSION


Clinical outcomes were equivalent at 2 years. Significantly more participants preferred their KA joint. Fewer releases were required using a KA technique. Participants were visually insensitive to modest hip-knee-ankle angle asymmetry.
LEVEL OF EVIDENCE


Level 1.",2020,"There were no significant differences with respect to flexion range (P = .970) or functional scores (mean KOOS, P = .941; KOOS JR, P = .685;",['primary total knee arthroplasty (TKA'],"['kinematic alignment (KA) and mechanical alignment (MA', 'Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty', 'bilateral TKA', 'Bilateral Simultaneous Surgery', 'computer-assisted bilateral TKA']","['flexion range', 'limb asymmetry', 'functional scores', 'preference and perception of limb symmetry; (3) intraoperative alignment data; (4) release and gap balance data; and (5) postoperative radiographic joint angles', '1) joint range of motion and functional scores including the KOOS, the KOOS JR, Oxford Knee Score, and the Forgotten Joint Score']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2938981', 'cui_str': 'Limb asymmetry'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}]",41.0,0.18527,"There were no significant differences with respect to flexion range (P = .970) or functional scores (mean KOOS, P = .941; KOOS JR, P = .685;","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McEwen', 'Affiliation': 'The Orthopaedic Research Institute of Queensland (ORIQL), Townsville, Queensland, Australia; North Queensland Knee, Mater Health Services North Queensland, Townsville, Queensland, Australia.'}, {'ForeName': 'Constantine E', 'Initials': 'CE', 'LastName': 'Dlaska', 'Affiliation': 'The Orthopaedic Research Institute of Queensland (ORIQL), Townsville, Queensland, Australia.'}, {'ForeName': 'Ivana A', 'Initials': 'IA', 'LastName': 'Jovanovic', 'Affiliation': 'The Orthopaedic Research Institute of Queensland (ORIQL), Townsville, Queensland, Australia.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'College of Healthcare Science, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Brandon', 'Affiliation': 'The Orthopaedic Research Institute of Queensland (ORIQL), Townsville, Queensland, Australia.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.064']
916,31528269,Ecological momentary assessment in posttraumatic stress disorder and coping. An eHealth study protocol.,"Background : It is well known from cross-sectional studies that individual coping strategies significantly influence the pathogenesis of posttraumatic stress disorder (PTSD). Equally, undisputed is the role of biological processes, e.g. of the so-called 'stress hormone' cortisol for the trajectory of PTSD. Ecological momentary assessment (EMA), the repeated collection of self-reported momentary states via smartphones, is ideal for shedding light upon symptom fluctuations and coping strategies. EMA may also constitute a promising approach to provide closer associations to biomarkers than retrospective self-report. The mobile application 'CoachPTBS', created to facilitate transition into health-care systems, bridges waiting periods for trauma-specific psychotherapy. CoachPTBS offers tools akin to EMA that could elucidate coping with stress symptoms. Moreover, the app's self-management tools may improve coping strategies. However, these processes have never been examined in a combined, longitudinal fashion.  Objective : The aim of the current study is to assess symptom fluctuations, coping strategies and long-term endocrine correlates of PTSD by a longitudinal, multimodal approach, combining traditional, online and EMA self-report with hair cortisol data and CoachPTBS as a possible novel mHealth tool.  Method : 120 participants waiting for PTSD psychotherapy will be randomly grouped. After in-situ assessment and hair sample collection, 40 will receive CoachPTBS, using it daily throughout 4 weeks. A parallel group of 40 will participate in EMA, completing daily questionnaires on symptoms and coping. In between, online surveys will be conducted. After 6 weeks, a final interview and another hair sample collection will follow. Comparisons between these groups and waitlist-control, also consisting of 40 PTSD participants, and 40 non-traumatized participants assessed via EMA regarding aversive emotions and coping are planned.  Discussion : Novel insights into the interplay of biological and coping strategies in PTSD are expected due to the innovative multimodal study design. Results will further explore benefits of eHealth tools on coping with PTSD.",2019,"The mobile application 'CoachPTBS', created to facilitate transition into health-care systems, bridges waiting periods for trauma-specific psychotherapy.","['Method : 120 participants waiting for PTSD psychotherapy will be randomly grouped', 'Discussion ']",['EMA'],[],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for (contextual qualifier) (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}]",[],120.0,0.0147854,"The mobile application 'CoachPTBS', created to facilitate transition into health-care systems, bridges waiting periods for trauma-specific psychotherapy.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lorenz', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Schindler', 'Affiliation': 'Department of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Steudte-Schmiedgen', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Kirschbaum', 'Affiliation': 'Department of Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schellong', 'Affiliation': 'Department of Psychotherapy and Psychosomatic Medicine, Medical Faculty Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}]",European journal of psychotraumatology,['10.1080/20008198.2019.1654064']
917,31529024,Intensive blood pressure lowering in different age categories: insights from the Systolic Blood Pressure Intervention Trial.,"AIMS


The 2018 ESC/ESH guidelines for hypertension recommend differential management of patients who are <65, 65-79, and ≥80 years of age. However, it is unclear whether intensive blood pressure lowering is well-tolerated and modifies risk uniformly across the age spectrum.
METHODS AND RESULTS


SPRINT randomized 9361 high-risk adults without diabetes and age ≥50 years with systolic blood pressure 130-180 mmHg to either intensive or standard antihypertensive treatment. The primary efficacy endpoint was the composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. The primary safety endpoint was composite serious adverse events. We assessed whether age modified the efficacy and safety of intensive vs. standard blood pressure lowering using Cox proportional-hazards regression and restricted cubic splines. In all, 3805 (41%), 4390 (47%), and 1166 (12%) were <65, 65-79, and ≥80 years. Mean age was similar between the two study groups (intensive group 67.9 ± 9.4 years vs. standard group 67.9 ± 9.5 years; P = 0.94). Median follow-up was 3.3 years. In multivariable models, age was linearly associated with the risk of stroke (P < 0.001) and non-linearly associated with the risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events (P < 0.001). The safety and efficacy of intensive blood pressure lowering were not modified by age, whether tested continuously or categorically (P > 0.05).
CONCLUSION


In SPRINT, the benefits and risks of intensive blood pressure lowering did not differ according to the age categories proposed by the ESC/ESH guidelines for hypertension.
TRIAL REGISTRATION


SPRINT (Systolic Blood Pressure Intervention Trial); ClinicalTrials.gov Identifier: NCT01206062, https://clinicaltrials.gov/ct2/show/NCT01206062.",2020,"In multivariable models, age was linearly associated with the risk of stroke (P < 0.001) and non-linearly associated with the risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events (P < 0.001).","['9,361 high-risk adults without diabetes and age ≥50 years with systolic blood pressure 130-180\u2009mmHg to either intensive or standard antihypertensive treatment', 'patients who are <65, 65-79, and ≥80 years of age']",[],"['risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events', 'risk of stroke', 'safety and efficacy of intensive blood pressure lowering', 'composite of acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes', 'composite serious adverse events']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]",,0.127612,"In multivariable models, age was linearly associated with the risk of stroke (P < 0.001) and non-linearly associated with the risk of primary efficacy events, death from cardiovascular causes, death from any cause, heart failure, and serious adverse events (P < 0.001).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet - Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.'}, {'ForeName': 'Manan', 'Initials': 'M', 'LastName': 'Pareek', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Department of Cardiology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX 75390, USA.'}, {'ForeName': 'Thomas Bastholm', 'Initials': 'TB', 'LastName': 'Olesen', 'Affiliation': 'Department of Internal Medicine, Hospital of Little Belt, Sygehusvej 24, 6000 Kolding, Denmark.'}, {'ForeName': 'Michael Hecht', 'Initials': 'MH', 'LastName': 'Olsen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Holbæk Hospital, Smedelundsgade 60, 4300 Holbæk, Denmark.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz050']
918,31529084,Transitional Hypoglycaemia Management in Small for Gestational Age Neonates with Sucrose Enriched Expressed Breastmilk in Resource Poor Setting.,"AIM


To find out if oral sucrose is as efficacious as intravenous dextrose (IVDx) in treating hypoglycaemia in small for gestational age (SGA) neonates and to compare risk of feed intolerance (FI) and necrotizing enterocolitis (NEC) in oral therapy with IVDx therapy.
METHODS


Eighty SGA haemodynamically stable hypoglycaemic [blood sugar (BS) < 40 mg/dl] neonates of ≥32 to ≤36 week gestational age were randomized to receive oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy (Group B; 40 in each group) in similar calculated doses. BS at 6 h after treatment, incidence of recurrence of hypoglycaemia, FI and NEC were compared.
RESULTS


Mean BS level at 6 h after treatment in oral supplementation group was 63.53 ± 22.12 mg/dl [3.52 ± 1.22 mmol/l (IQR 49.2-82 mg/dl, 2.7-4.5 mmol/l) vs. 71.28 ± 31.76 mg/dl [3.96 ± 1.76 mmol/l (IQR 48.5-73 mg/dl, 2.69-4 mmol/l) in IVDx group, p = 0.209. Relative risk (RR) of recurrence of hypoglycaemia in oral vs. IV treatment was 1.5 with 95% CI 0.4578-4.9151. Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
CONCLUSION


In resource poor setting in haemodynamically stable hypoglycaemic SGA neonates, EBM enriched with calculated dose of sucrose given orally maintains euglycaemia (BS 40-125mg/dl, 2.2-6.9 mmol/l) without increased incidence of FI and NEC. This method also prevents lactational failure.",2020,"Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
","['treating hypoglycaemia in small for gestational age (SGA) neonates', '\u200940 mg/dl] neonates of ≥32 to ≤36\u2009week gestational age', 'Eighty']","['oral sucrose', 'dextrose (IVDx', 'oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy']","['incidence of recurrence of hypoglycaemia, FI and NEC', 'Relative risk (RR) of recurrence of hypoglycaemia', 'Incidence of FI', 'Mean BS level', 'incidence of FI and NEC', 'SGA haemodynamically stable hypoglycaemic [blood sugar (BS', 'Transitional Hypoglycaemia Management']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0150254', 'cui_str': 'Hypoglycemia management'}]",80.0,0.148124,"Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Bora', 'Affiliation': 'Neonatal Unit, Department of Paediatrics, Assam Medical College, Dibrugarh, Assam, India.'}, {'ForeName': 'Sumon', 'Initials': 'S', 'LastName': 'Deori', 'Affiliation': 'Neonatal Unit, Department of Paediatrics, Assam Medical College, Dibrugarh, Assam, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz064']
919,31521870,Tyrosine negatively affects flexible-like behaviour under cognitively demanding conditions.,"BACKGROUND


The catecholaminergic precursor to dopamine, tyrosine, is an important modulator of cognitive performance. A number of studies have demonstrated that the beneficial effects of tyrosine on cognitive performance are most pronounced when individuals are exposed to stressful situations, such as hypothermia. However, little is known about whether manipulation of stress using non-aversive stimuli, such as cognitive demand, can also bring about similar improvements.
METHODS


We conducted a randomized, double-blind, placebo-controlled experiment to test the effects of tyrosine administration and cognitive load (low or high) on cognitive flexibility, a measure known to be influenced by catecholaminergic function. A total of 70 healthy volunteers completed a baseline cognitive flexibility test (Wisconsin Card Sorting Test: WCST). Participants were given a dose of either tyrosine (2.0 g) or placebo (cellulose) and subject to either low cognitive load (simple reaction time task) or high cognitive load (digit memory span task), immediately followed by a WCST for a second time.
RESULTS


Contrary to expectations, we found that instead of ameliorating performance under the high cognitive load condition, tyrosine worsened cognitive flexibility.
LIMITATIONS


Physiological marker of stress was not measured.
CONCLUSIONS


Our results suggest that aversive stressors and cognitive demand modulate the effects of tyrosine on cognitive performance in a differential manner.",2020,"Contrary to expectations, we found that instead of ameliorating performance under the high cognitive load condition, tyrosine worsened cognitive flexibility.
",['70 healthy volunteers'],"['baseline cognitive flexibility test (Wisconsin Card Sorting Test: WCST', 'placebo', 'tyrosine', 'tyrosine administration and cognitive load (low or high', 'placebo (cellulose) and subject to either low cognitive load (simple reaction time task) or high cognitive load (digit memory span task), immediately followed by a WCST']","['cognitive performance', 'cognitive flexibility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin Card Sorting Test'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",70.0,0.138341,"Contrary to expectations, we found that instead of ameliorating performance under the high cognitive load condition, tyrosine worsened cognitive flexibility.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Robson', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: ar2091@exchange.shu.ac.uk.'}, {'ForeName': 'Lee Wei', 'Initials': 'LW', 'LastName': 'Lim', 'Affiliation': 'School of Biomedical Sciences, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pok Fu Lam, Hong Kong, China.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Aquili', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.031']
920,31811645,Adjunctive use of enamel matrix derivatives to porcine-derived xenograft for the treatment of one-wall intrabony defects: Two-year longitudinal results of a randomized controlled clinical trial.,"BACKGROUND


The purpose of this study was to evaluate the potential advantages of adjunctive use of enamel matrix protein derivative (EMD) in combination with demineralized porcine bone matrix (DPBM) for the treatment of one-wall intrabony defects in the molar regions, in comparison with the use of DPBM alone, through a randomized controlled clinical trial.
METHODS


Forty-two participants were randomly assigned to two groups: one where DPBM with the adjunctive use of EMD (test group, n = 20) was applied and the other without EMD (control group, n = 22). Changes in the clinical and radiographic parameters from baseline at 6, 12, and 24 months were measured (probing pocket depth, clinical attachment loss, defect depth, and defect width). Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration) were also assessed.
RESULTS


Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events. However, no statistically significant differences in any of the measured parameters were found when the two groups were compared. Early wound healing outcomes and the severity of swelling did not differ between the groups, but the severity of pain (P = 0.046), duration (P = 0.033), and swelling (P = 0.022) were significantly lower in the test group.
CONCLUSIONS


DPBM has been verified for biocompatibility and can be used as a scaffold to enhance the clinical and radiographic outcomes of periodontal regeneration of one-wall intrabony defects. In particular, the adjunctive use of EMD significantly reduced the postoperative discomfort.",2020,"Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events.",['Forty-two participants'],"['demineralized porcine bone matrix (DPBM', 'enamel matrix derivatives to porcine-derived xenograft', 'enamel matrix protein derivative (EMD', 'DPBM with the adjunctive use of EMD']","['severity of pain', 'Postoperative discomfort (severity/duration of pain and swelling) and early soft tissue wound healing (dehiscence/fenestration, persistent swelling, spontaneous bleeding, and ulceration', 'swelling', 'clinical attachment loss, defect depth, and defect width', 'clinical and radiographic outcomes', 'Early wound healing outcomes', 'postoperative discomfort', 'severity of swelling']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0005962', 'cui_str': 'Bone Matrix'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C0893442', 'cui_str': 'enamel matrix proteins'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0337280', 'cui_str': 'Fenestration - action (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]",42.0,0.0371864,"Both treatment modalities, with and without EMD, resulted in significant improvement of clinical and radiographic outcomes without any severe adverse events.","[{'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}, {'ForeName': 'Do-Hyung', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}, {'ForeName': 'Seong-Nyum', 'Initials': 'SN', 'LastName': 'Jeong', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, Korea.'}]",Journal of periodontology,['10.1002/JPER.19-0432']
921,31128269,"Editorial: What Constitutes ""Evidence-Based"" Educational Practice?","The requirement for educational provision for all children to be evidence based has been highlighted in many government policies. 1  The significant additional costs of educating children with autism, and difficulties in recruiting adequately trained teachers, have placed increasing pressure on education authorities to provide more cost-effective instruction methods for pupils with autism. Computer-assisted interventions (CAI) have been suggested as a possible means of meeting the educational needs of this group, and findings from mostly small, uncontrolled studies have indicated positive improvements in areas such as academic ability, social and communication skills, and adaptive behavior. 2  The present study by Pellecchia et al. 3  describes an evaluation of one such program: TeachTown: Basics. This is a computer-assisted intervention that aims to increase students' vocabulary, listening skills, socio-emotional development, and academic and cognitive abilities. It is designed for children with autism or other developmental disabilities with a nonverbal mental age equivalent of 2 to 7 years. A brief (20 minutes per day for 3 months), small-scale (n = 22, children 3-6-years of age), randomized control trial (RCT) of TeachTown: Basics, previously conducted in the Los Angeles Unified School District, 4  produced some positive but generally nonsignificant changes in language and cognitive measures compared with a control group. Although the authors themselves were cautious about the results, this very limited evidence from a single RCT was enough for the School District of Philadelphia (the eighth largest district in the country) to decide to roll out the program to students in all of its kindergarten to second grade autism support classrooms.",2020,"This is a computer-assisted intervention that aims to increase students' vocabulary, listening skills, socio-emotional development, and academic and cognitive abilities.","['pupils with autism', 'children with autism or other developmental disabilities with a nonverbal mental age equivalent of 2 to 7 years', 'Editorial']",['Computer-assisted interventions (CAI'],"[""students' vocabulary, listening skills, socio-emotional development, and academic and cognitive abilities""]","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282412', 'cui_str': 'Editorial'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0357278,"This is a computer-assisted intervention that aims to increase students' vocabulary, listening skills, socio-emotional development, and academic and cognitive abilities.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Howlin', 'Affiliation': ""The Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK. Electronic address: patricia.howlin@kcl.ac.uk.""}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.05.013']
922,32431275,Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial.,"A cluster-randomized, double-blinded, placebo-controlled trial was conducted to estimate the protective efficacy (PE) of a spatial repellent (SR) against malaria infection in Sumba, Indonesia. Following radical cure in 1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given transfluthrin or placebo passive emanators (devices designed to release vaporized chemical). Monthly blood screening and biweekly human-landing mosquito catches were performed during a 10-month baseline (June 2015-March 2016) and a 24-month intervention period (April 2016-April 2018). Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households. The 24-cluster protective effect of 27.7% and 31.3%, for time to first-event and overall (total new) infections, respectively, was not statistically significant. Purportedly, this was due in part to zero to low incidence in some clusters, undermining the ability to detect a protective effect. Subgroup analysis of 19 clusters where at least one infection occurred during baseline showed 33.3% ( P -value = 0.083) and 40.9% ( P -value = 0.0236, statistically significant at the one-sided 5% significance level) protective effect to first infection and overall infections, respectively. Among 12 moderate- to high-risk clusters, a statistically significant decrease in infection by intervention was detected (60% PE). Primary entomological analysis of impact was inconclusive. Although this study suggests SRs prevent malaria, additional evidence is required to demonstrate the product class provides an operationally feasible and effective means of reducing malaria transmission.",2020,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","['Control of Malaria in Indonesia', '1,341 children aged ≥ 6 months to ≤ 5 years in 24 clusters, households were given', '667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households']","['transfluthrin or placebo passive emanators (devices designed to release vaporized chemical', 'Monthly blood screening and biweekly human-landing mosquito catches', 'placebo']","['infection by intervention', 'protective efficacy (PE', '24-cluster protective effect', 'time to first-event and overall (total new) infections']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3178479', 'cui_str': 'transfluthrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086137', 'cui_str': 'Device Design'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205314', 'cui_str': 'New'}]",1341.0,0.277179,"Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households, and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households.","[{'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Department of Parasitology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Puji B S', 'Initials': 'PBS', 'LastName': 'Asih', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Ismail Ekoprayitno', 'Initials': 'IE', 'LastName': 'Rozi', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Dendi Hadi', 'Initials': 'DH', 'LastName': 'Permana', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Anggi Puspa', 'Initials': 'AP', 'LastName': 'Nur Hidayati', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Lepa', 'Initials': 'L', 'LastName': 'Syahrani', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Zubaidah', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Sidik', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Universitas Hasanuddin, Makassar, Indonesia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Bangs', 'Affiliation': 'Public Health and Malaria Control, PT Freeport Indonesia, International SOS, Kuala Kencana, Papua, Indonesia.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bøgh', 'Affiliation': 'The Sumba Foundation, Public Health and Malaria Control, Bali, Indonesia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Applied and Computational Mathematics and Statistics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Evercita C', 'Initials': 'EC', 'LastName': 'Eugenio', 'Affiliation': 'Department of Applied and Computational Mathematics and Statistics, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Hendrickson', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'J Kevin', 'Initials': 'JK', 'LastName': 'Baird', 'Affiliation': 'Nuffield Department of Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Collins', 'Affiliation': 'Center for Computer Research, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Grieco', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Neil F', 'Initials': 'NF', 'LastName': 'Lobo', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Achee', 'Affiliation': 'Department of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, Notre Dame, Indiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0554']
923,32067098,The effect of polyphenol-rich chardonnay seed supplements on peripheral endothelial function.,"OBJECTIVE


Peripheral endothelial dysfunction (PED) is associated with major adverse cardiovascular events. Similar to cardio-protective Mediterranean diet, Chardonnay seeds are rich in polyphenols, fibers, and grape seed oil. In this randomized double-blinded trial, we investigated safety and incremental benefit of Chardonnay seed polyphenols-rich (PR), compared to polyphenols-free (PF), supplements on PED.
METHODS


89 patients with PED [reactive hyperemia-peripheral arterial tonometry (RH-PAT) index ≤ 2) were randomized 1:1 to 4.8 g (6 capsules)/day PR or PF for 4 months. PR and PF capsules had equal amounts of seed oil (~ 7% capsule weight), fibers, and carbohydrates, but only PR capsules contained polyphenols (~ 11% capsule weight). Baseline and follow-up RH-PAT indices (primary endpoint) and endothelial progenitor cells (EPC) levels were measured. Patients were asked to maintain their regular diet and exercise habits during study period.
RESULTS


Baseline RH-PAT indices, demographics, lab values, and EPC levels were similar between groups. No significant adverse reactions to PR or PF were reported. Follow-up RH-PAT indices significantly increased (p < 0.05 vs. baseline) in both groups to similar extent (31 ± 39% PR vs. 49 ± 53% PF, p = 0.09). Circulating CD34 + EPCs equally increased (median + 55% vs. + 54%, p = 0.94) in PR and PF groups, respectively.
CONCLUSION


PR and PF Chardonnay seed supplements were safe and improved peripheral endothelial function to similar extent in PED patients. However, there were no incremental benefits of PR over PF on RH-PAT indices or CD34 + EPC levels. Chardonnay seed supplements role in primary prevention of atherosclerosis, as add-on to healthy lifestyle and guidelines directed medical therapy, should be further explored. CLINICALTRIALS.
GOV IDENTIFIER (NCT NUMBER)


NCT02093455.",2020,"However, there were no incremental benefits of PR over PF on RH-PAT indices or CD34 + EPC levels.",['89 patients with PED [reactive hyperemia-peripheral arterial tonometry (RH-PAT) index\u2009≤\u20092'],"['polyphenols-free (PF), supplements', 'Chardonnay seed polyphenols-rich (PR', 'polyphenol-rich chardonnay seed supplements']","['Baseline RH-PAT indices, demographics, lab values, and EPC levels', 'adverse reactions to PR or PF', 'Circulating CD34\u2009+\u2009EPCs', 'endothelial progenitor cells (EPC) levels', 'peripheral endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0030587', 'cui_str': 'Paroxysmal atrial tachycardia (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",89.0,0.173296,"However, there were no incremental benefits of PR over PF on RH-PAT indices or CD34 + EPC levels.","[{'ForeName': 'Michel T', 'Initials': 'MT', 'LastName': 'Corban', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Robert Jay', 'Initials': 'RJ', 'LastName': 'Widmer', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cilluffo', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Makinzee A', 'Initials': 'MA', 'LastName': 'Kazeck', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Lennon', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.'}, {'ForeName': 'Lilach O', 'Initials': 'LO', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, 200 First Street SW, Rochester, MN, 55905, USA. lerman.amir@mayo.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02203-6']
924,32431047,Subjective-objective sleep discrepancy in patients with insomnia during and after cognitive behavioural therapy: An actigraphy study.,"Although patients with insomnia often show a discrepancy between self-reported and objective sleep parameters, the role of and change in this phenomenon during treatment remain unclear. The present study aimed to assess the effect of cognitive behavioural therapy for insomnia on subjective and objective sleep discrepancy of total sleep time, sleep-onset latency and wake after sleep onset. The total sleep time discrepancy was also assessed across the entire therapy. The second aim was to examine the treatment outcome of two insomnia groups differing in sleep perception. Thirty-six adults with insomnia (mean age = 46.7 years, SD = 13.9; 22 females) were enrolled in the final analyses. Patients underwent a 6-week group cognitive behavioural therapy for insomnia programme. Sleep diary and actigraphy measurements were obtained during the therapy. Patients who underestimated total sleep time (n = 16; underestimating group) were compared with patients who accurately perceived or overestimated total sleep time (n = 20; accurate/overestimating group). After cognitive behavioural therapy for insomnia, a significant decrease of total sleep time and sleep-onset latency discrepancy was observed without a change in wake after sleep onset discrepancy in the total sample. Only the underestimating group reported decreased sleep-onset latency discrepancy after the treatment, whereas total sleep time discrepancy significantly changed in both groups. The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4. In conclusion, both groups differing in sleep perception responded similarly to cognitive behavioural therapy for insomnia, although different In conclusion, both groups differing in sleep perception responded similarly to cognitive behavioural therapy for insomnia, although different therapeutic components could play important roles in each group. components could play important roles in each group.",2020,"The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4.","['Thirty-six adults with insomnia (mean age\xa0=\xa046.7\u2005years, SD\xa0=\xa013.9; 22 females', 'patients with insomnia during and after cognitive behavioural therapy']","['cognitive behavioural therapy', '6-week group cognitive behavioural therapy']","['subjective and objective sleep discrepancy of total sleep time, sleep-onset latency and wake after sleep onset', 'total sleep time', 'Subjective-objective sleep discrepancy', 'Sleep diary and actigraphy measurements', 'total sleep time and sleep-onset latency discrepancy', 'total sleep time discrepancy', 'sleep-onset latency discrepancy']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",36.0,0.0152607,"The underestimating group showed a significant decrease of total sleep time discrepancy from Week 1 to Week 2 when the sleep restriction was implemented, whereas the accurate/overestimating group showed the first significant change at Week 4.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janků', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Šmotek', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fárková', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kopřivová', 'Affiliation': 'National Institute of Mental Health, Klecany, Czech Republic.'}]",Journal of sleep research,['10.1111/jsr.13064']
925,31433930,Fornix-Region Deep Brain Stimulation-Induced Memory Flashbacks in Alzheimer's Disease.,,2019,,"[""Alzheimer's Disease""]",['Fornix-Region Deep Brain Stimulation-Induced Memory Flashbacks'],[],"[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0152334', 'cui_str': 'Cerebral fornix structure'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks (disorder)'}]",[],,0.0516592,,"[{'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Deeb', 'Affiliation': 'University of Florida, Gainesville, FL wissam.deeb@neurology.ufl.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Salvato', 'Affiliation': 'Florida State University, Tallahassee, FL.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Almeida', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Amaral', 'Affiliation': 'Douglas Mental Health University Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Germann', 'Affiliation': 'Douglas Mental Health University Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Tang-Wai', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Anna D', 'Initials': 'AD', 'LastName': 'Burke', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Salloway', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Marwan N', 'Initials': 'MN', 'LastName': 'Sabbagh', 'Affiliation': 'Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV.'}, {'ForeName': 'M Mallar', 'Initials': 'MM', 'LastName': 'Chakravarty', 'Affiliation': 'Douglas Mental Health University Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Gwenn S', 'Initials': 'GS', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Constantine G', 'Initials': 'CG', 'LastName': 'Lyketsos', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Lozano', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'University of Florida, Gainesville, FL.'}]",The New England journal of medicine,['10.1056/NEJMc1905240']
926,19427708,[Repeat prescription management systems: strategy for optimising their use].,"OBJECTIVE


To improve patient compliance with a repeat prescription system. To evaluate the reasons for not being punctual in collecting prescriptions and the non-compliance declared by the patients themselves.
DESIGN


Quasi-experimental study before and after intervention including a control group.
SETTING


Primary health care centre which serves a population of 62,981 inhabitants.
PARTICIPANTS


Patients with chronic diseases included in the repeat prescription management system (100 in the control group and 100 in the intervention group) who were unpunctual in collecting their prescriptions.
INTERVENTIONS


An informative-educational session consisting of a short interview with the pharmacist from Primary Health Care Centre, in which the patient was educated on compliance of the repeat prescription system and treatment. The reasons for the unpunctuality were identified and the Moriskey-Green test was performed.
MAIN MEASUREMENTS


Punctuality of the patients in collecting their prescriptions after the intervention. Reasons for unpunctuality recorded at recruitment. Therapeutic compliance according to the Moriskey-Green test.
RESULTS


There was an overall absolute improvement of 17% in punctuality in the intervention group (60% of the patients in the intervention group and 43% in the control group were punctual in the first as well as in the second follow up. Women were more punctual in the intervention group. There were no differences seen due to age, number of medications or reason for unpunctuality.
CONCLUSIONS


It is possible to improve patient compliance with the prescription renewal system using a simple informative-educational intervention.",2009,There was an overall absolute improvement of 17% in punctuality in the intervention group (60% of the patients in the intervention group and 43% in the control group were punctual in the first as well as in the second follow up.,"['Patients with chronic diseases included in the repeat prescription management system (100 in the control group and 100 in the intervention group) who were unpunctual in collecting their prescriptions', 'Primary health care centre which serves a population of 62,981 inhabitants']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0420263', 'cui_str': 'Repeated prescription'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],62981.0,0.0157332,There was an overall absolute improvement of 17% in punctuality in the intervention group (60% of the patients in the intervention group and 43% in the control group were punctual in the first as well as in the second follow up.,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Llobet Traveset', 'Affiliation': 'CAP Rambla, Unidad de Farmacia de Atención Primaria, Mútua de Terrassa, Terrassa, Barcelona, España. Electronic address: ellobet@mutuaterrassa.es.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Madridejos Mora', 'Affiliation': 'CAP Rambla, Unidad de Farmacia de Atención Primaria, Mútua de Terrassa, Terrassa, Barcelona, España.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Tomás Sanz', 'Affiliation': 'CAP Rambla, Unidad de Farmacia de Atención Primaria, Mútua de Terrassa, Terrassa, Barcelona, España.'}]",Atencion primaria,['10.1016/j.aprim.2008.09.021']
927,31525120,"The Nutrition Health Alliance (NutriHeAl) Study: A Randomized, Controlled, Nutritional Intervention Based on Mediterranean Diet in Greek Municipalities.","Objective:  The aim of this study was to evaluate the effects of Mediterranean diet on weight loss in a large population in a municipality setting. Methods:  A 6-month nutritional intervention was implemented in 50 randomly selected municipalities in Greece. In each municipality, approximately 180 overweight or obese patients were recruited and randomly assigned to an intervention group (n = 4500) or to a control group (n = 4500); 1816 and 2210 patients, respectively, completed the study. At baseline, the intervention group attended a 20-minute session where they received recommendations to follow a personalized, slightly hypocaloric, Mediterranean-type diet. The diet was adjusted every 2 weeks. The control group was provided with a leaflet on healthy nutrition and Mediterranean diet. Adherence to Mediterranean diet was evaluated with the Mediterranean diet score (MedDietScore). Results:  Subjects in the intervention group were less frequently males and current smokers, had higher body mass index, and followed a healthier diet at baseline than subjects in the control group. In the intervention group, weight, waist circumference, and body fat percentage decreased. In the control group, weight and waist circumference increased. In the intervention group, 48.8% of subjects lost > 5% of body weight compared with 4.2% in the control group ( p  < 0.001). The MedDietScore increased in the intervention group and did not change in the control group. Independent predictors of loss > 5% of body weight were the decrease in intake of full-fat dairy products and alcohol and the increase in intake of vegetables, in MedDietScore, in walking and in consuming breakfast. Conclusions:  Lifestyle change programs focusing on the adoption of Mediterranean diet with frequent monitoring can be implemented successfully in everyday clinical practice. However, retention rates in such programs need to be improved.",2020,The MedDietScore increased in the intervention group and did not change in the control group.,"['large population in a municipality setting', 'in Greek Municipalities', 'n\u2009=\u20094500); 1816 and 2210 patients, respectively, completed the study', 'In each municipality, approximately 180 overweight or obese patients']","['intervention group (n\u2009=\u20094500) or to a control group', 'healthy nutrition and Mediterranean diet', 'Mediterranean diet', 'Mediterranean Diet']","['weight, waist circumference, and body fat percentage decreased', 'weight and waist circumference', 'body weight', 'weight loss', 'intake of vegetables, in MedDietScore, in walking and in consuming breakfast', 'Nutrition Health Alliance (NutriHeAl', 'retention rates', 'MedDietScore', 'Mediterranean diet score (MedDietScore']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0600182'}, {'cui': 'C0554965', 'cui_str': 'Greek (NMO) (ethnic group)'}, {'cui': 'C4517780', 'cui_str': 'Four thousand five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517780', 'cui_str': 'Four thousand five hundred'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0282389', 'cui_str': 'Health Alliances'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",2210.0,0.0250788,The MedDietScore increased in the intervention group and did not change in the control group.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hassapidou', 'Affiliation': 'Department of Nutrition and Dietetics, Alexander Technological Educational Institute of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tziomalos', 'Affiliation': 'First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Lazaridou', 'Affiliation': 'First Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pagkalos', 'Affiliation': 'Department of Electronics and Computer Engineering, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Konstantina', 'Initials': 'K', 'LastName': 'Papadimitriou', 'Affiliation': 'Department of Nutrition and Dietetics, Alexander Technological Educational Institute of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kokkinopoulou', 'Affiliation': 'Department of Nutrition and Dietetics, Alexander Technological Educational Institute of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Themistoklis', 'Initials': 'T', 'LastName': 'Tzotzas', 'Affiliation': 'Department of Nutrition and Dietetics, Alexander Technological Educational Institute of Thessaloniki, Thessaloniki, Greece.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1660928']
928,31525129,Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes.,"Objective:  This study was designed to assess the effects of replacing high-carbohydrate (CHO) foods with raw almonds on insulin sensitivity and cardiometabolic health markers in overweight or obese adults with prediabetes. Method:  This randomized crossover study consisted of two 6-week dietary intervention periods, separated by a ≥ 4-week washout. Subjects incorporated 1.5 oz of raw almonds twice daily or isocaloric CHO-based foods into their diets, with instructions to maintain body weight. Dietary intakes as well as insulin sensitivity, CHO metabolism indices, lipoprotein lipids and particles, and inflammatory markers were assessed. Results:  Thirty-three subjects (17 male, 16 female), mean age 48.3 ± 2.2 years and body mass index 30.5 ± 0.7 kg/m 2 , provided evaluable data. Compared to CHO, almonds resulted in significantly ( p  < 0.01) higher intakes of protein, fat (unsaturated fatty acids), fiber, and magnesium and significantly ( p  < 0.001) lower intakes of CHO and sugars. No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis. No significant differences were observed in biomarkers of cardiovascular risk except that the CHO intervention led to a shift toward a higher concentration of cholesterol in small, dense low-density lipoprotein subfraction 3+4 (LDL3 + 4) particles ( p  = 0.024 vs almonds). Conclusions:  Intake of 3.0 oz/d raw almonds, vs energy-matched CHO foods, improved the dietary nutrient profile, but did not significantly affect insulin sensitivity and most markers of cardiometabolic health in overweight and obese men and women with prediabetes.",2020,No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis.,"['Adults With Prediabetes', 'overweight and obese men and women with prediabetes', 'Results:  Thirty-three subjects (17 male, 16 female), mean age 48.3\u2009±\u20092.2\u2009years and body mass index 30.5\u2009±\u20090.7\u2009kg/m 2 , provided evaluable data', 'overweight or obese adults with prediabetes']","['isocaloric CHO-based foods into their diets', 'replacing high-carbohydrate (CHO) foods with raw almonds']","['insulin sensitivity', 'concentration of cholesterol in small, dense low-density lipoprotein subfraction', 'intakes of protein, fat (unsaturated fatty acids), fiber, and magnesium', 'cardiometabolic health', 'insulin sensitivity and cardiometabolic health markers', 'insulin sensitivity index', 'Insulin Sensitivity and Other Cardiometabolic Health Markers', 'biomarkers of cardiovascular risk', 'insulin sensitivity, CHO metabolism indices, lipoprotein lipids and particles, and inflammatory markers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0453803', 'cui_str': 'High carbohydrate food (substance)'}, {'cui': 'C0440286', 'cui_str': 'Almonds'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0578543', 'cui_str': 'Low density lipoprotein subfraction (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",33.0,0.0492321,No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis.,"[{'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, USA.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': 'Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Illinois, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, Florida, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, USA.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, Florida, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, Illinois, USA.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Illinois, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Illinois, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1660929']
929,31954417,Promoting healthy eating by enhancing the correspondence between attitudes and behavioral intentions.,"BACKGROUND


Healthy eating campaigns are not always successful in changing food-related attitudes. Even when interventions produce the desired outcomes in attitudes, it is often challenging to translate those psychological changes into subsequent behaviors. Previous research has shown that elaboration (amount of thinking) is a critical construct for understanding the ability of attitudes to guide behavior. Instead of looking directly at objective elaboration, this study examined attitude-behavior correspondence as a function of subjective elaboration.
METHOD


Participants were first randomly assigned to generate positive or negative arguments with regard to taxing junk food. After this experimental manipulation, participants reported their subjective elaboration (as an additional predictor), and their attitudes and behavioral intentions regarding the proposal (as dependent measures).
RESULTS


As hypothesized, the results showed that the greater perceived elaboration, the larger the ability of attitudes to guide behavioral intentions. That is, attitudes were more predictive of behavioral intentions in participants with higher levels of perceived elaboration compared to those with relatively lower levels of subjective thinking.
CONCLUSION


Health initiatives can benefit from considering the extent to which participants perceive thinking about persuasive proposals.",2020,"As hypothesized, the results showed that the greater perceived elaboration, the larger the ability of attitudes to guide behavioral intentions.",['Participants'],[],[],[],[],[],,0.0154715,"As hypothesized, the results showed that the greater perceived elaboration, the larger the ability of attitudes to guide behavioral intentions.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Requero', 'Affiliation': 'Centro Universitario Villanueva.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Briñol', 'Affiliation': ''}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Paredes', 'Affiliation': ''}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Gandarillas', 'Affiliation': ''}]",Psicothema,['10.7334/psicothema2019.154']
930,31329855,"N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels.","AIMS


Elevated apolipoprotein C-III (apoC-III) levels are associated with hypertriglyceridaemia and coronary heart disease. AKCEA-APOCIII-LRx is an N-acetyl galactosamine-conjugated antisense oligonucleotide targeted to the liver that selectively inhibits apoC-III protein synthesis.
METHODS AND RESULTS


The safety, tolerability, and efficacy of AKCEA-APOCIII-LRx was assessed in a double-blind, placebo-controlled, dose-escalation Phase 1/2a study in healthy volunteers (ages 18-65) with triglyceride levels ≥90 or ≥200 mg/dL. Single-dose cohorts were treated with 10, 30, 60, 90, and 120 mg subcutaneously (sc) and multiple-dose cohorts were treated with 15 and 30 mg weekly sc for 6 weeks or 60 mg every 4 weeks sc for 3 months. In the single-dose cohorts treated with 10, 30, 60, 90, or 120 mg of AKCEA-APOCIII-LRx, median reductions of 0, -42%, -73%, -81%, and -92% in apoC-III, and -12%, -7%, -42%, -73%, and -77% in triglycerides were observed 14 days after dosing. In multiple-dose cohorts of 15 and 30 mg weekly and 60 mg every 4 weeks, median reductions of -66%, -84%, and -89% in apoC-III, and -59%, -73%, and -66% in triglycerides were observed 1 week after the last dose. Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed. AKCEA-APOCIII-LRx was well tolerated with one injection site reaction of mild erythema, and no flu-like reactions, platelet count reductions, liver, or renal safety signals.
CONCLUSION


Treatment of hypertriglyceridaemic subjects with AKCEA-APOCIII-LRx results in a broad improvement in the atherogenic lipid profile with a favourable safety and tolerability profile. ClinicalTrials.gov Identifier: NCT02900027.",2019,"Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed.",['healthy volunteers (ages 18-65) with triglyceride levels ≥90 or ≥200\u2009mg/dL. Single-dose cohorts'],[],"['atherogenic lipid profile', 'APOC3 mRNA, triglycerides and atherogenic lipoprotein levels', 'Elevated apolipoprotein C-III (apoC-III) levels', 'safety, tolerability, and efficacy of AKCEA-APOCIII-LRx', 'total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C', 'triglycerides']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",[],"[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0052191', 'cui_str': 'Apolipoprotein CIII'}, {'cui': 'C4048315', 'cui_str': 'ApoC-III'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0574537,"Significant reductions in total cholesterol, apolipoprotein B, non-high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, and increases in HDL-C were also observed.","[{'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Alexander', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Eunju', 'Initials': 'E', 'LastName': 'Hurh', 'Affiliation': 'Akcea Therapeutics, 22 Boston Wharf Road, 9th Floor, Boston, MA, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Hughes', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': ""O'Dea"", 'Affiliation': 'Akcea Therapeutics, 22 Boston Wharf Road, 9th Floor, Boston, MA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, USA.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Ionis Pharmaceuticals, Inc., 2855 Gazelle Ct, Carlsbad, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehz209']
931,31968697,"Influence of Dietary Advice Including Green Vegetables, Beef, and Whole Dairy Products on Recurrent Upper Respiratory Tract Infections in Children: A Randomized Controlled Trial.","BACKGROUND


Since no treatment exists for children suffering from upper respiratory tract infections (URTIs) without immunological disorders, we searched for a possible tool to improve the health of these children.
AIM


We evaluated whether dietary advice (based on food matrix and food synergy), including standard supportive care, can decrease the number and duration of URTIs in children with recurrent URTIs.
DESIGN AND SETTING


This study was a multicenter randomized controlled trial in two pediatric outpatient clinics in the Netherlands, with 118 children aged one to four years with recurrent URTIs. The dietary advice group received dietary advice plus standard supportive care, while the control group received standard supportive care alone for six months. The dietary advice consisted of green vegetables five times per week, beef three times per week, 300 mL whole milk per day, and whole dairy butter on bread every day. Portion sizes were age-appropriate.
RESULTS AND CONCLUSION


Children in the dietary advice group had 4.8 (1.6-9.5) days per month with symptoms of an URTI in the last three months of the study, compared to 7.7 (4.0-12.3) in the control group ( p  = 0.028). The total number of URTIs during the six-month study period was 5.7 (0.55) versus 6.8 (0.49), respectively ( p  = 0.068). The use of antibiotics was significantly reduced in the dietary advice group, as well as visits to a general practitioner, thereby possibly reducing healthcare costs. The results show a reduced number of days with symptoms of a URTI following dietary advice. The number of infections was not significantly reduced.",2020,"The use of antibiotics was significantly reduced in the dietary advice group, as well as visits to a general practitioner, thereby possibly reducing healthcare costs.","['children with recurrent URTIs', 'two pediatric outpatient clinics in the Netherlands, with 118 children aged one to four years with recurrent URTIs', 'Children', 'children suffering from upper respiratory tract infections (URTIs) without immunological disorders']","['Dietary Advice Including Green Vegetables, Beef, and Whole Dairy Products', 'dietary advice group received dietary advice plus standard supportive care, while the control group received standard supportive care alone', 'dietary advice (based on food matrix and food synergy']","['number of infections', 'number and duration of URTIs', 'total number of URTIs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",2.0,0.0479452,"The use of antibiotics was significantly reduced in the dietary advice group, as well as visits to a general practitioner, thereby possibly reducing healthcare costs.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Gaag', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 17609 PP Almelo, The Netherlands.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Brandsema', 'Affiliation': 'Department of BMS, University Twente, 57522 NB Enschede, The Netherlands.'}, {'ForeName': 'Rosan', 'Initials': 'R', 'LastName': 'Nobbenhuis', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 17609 PP Almelo, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of BMS, University Twente, 57522 NB Enschede, The Netherlands.'}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Medical Spectrum Twente, 17512 KZ Enschede, The Netherlands.'}]",Nutrients,['10.3390/nu12010272']
932,19328598,[Study on the use of a smart pillbox to improve treatment compliance].,"OBJECTIVE


To assess the usefulness of the Practidose individualised dispensing and dosing pillbox system in improving treatment compliance (TC).
DESIGN


Open-labelled, randomised, clinical trial.
SETTING


Cordoba province from April to September 2005.
PARTICIPANTS AND CONTEXT


A total of 220 patients 70 years diagnosed with ineffective management of treatment regime, polymedicated with no cognitive deterioration or limited mobility. Enrolment was carried out by block random assignment. Each district linking nurse was assigned 10 interviews, 5 from the intervention group and 5 from a control group.
INTERVENTION


To give a smart pillbox with instructions. MEASUREMENTS AND PRIMARY OUTCOMES: The response variable was the TC measured using the Morisky-Green questionnaire at the beginning and at 2 months. The independent variables were: age, sex, education level, number of people living in the home and mean age, diabetes, hypertension, heart disease, COPD, number of medications, number of daily and weekly doses self-medication, and interest in the patient information leaflet. A descriptive analysis and a multiple logistic regression were performed on the data. A total of 182 patients finished the study. The TC improved by 6.74% in the intervention group and by 2.15% in the control group. To look after the medications and suffer from COPD lead to better TC, and was less so when there was interest in the patient information leaflet.
CONCLUSIONS


The improvement in treatment compliance with the Practidose Pillbox was not statistically significant, although a positive tendency was observed.",2009,"The improvement in treatment compliance with the Practidose Pillbox was not statistically significant, although a positive tendency was observed.","['182 patients finished the study', 'people living in the home and mean age, diabetes, hypertension, heart disease, COPD, number of medications, number of daily and weekly doses self-medication, and interest in the patient information leaflet', '220 patients 70 years diagnosed with ineffective management of treatment regime, polymedicated with no cognitive deterioration or limited mobility', 'Cordoba province from April to September 2005']","['smart pillbox', 'Practidose individualised dispensing and dosing pillbox system']",['TC'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0036600', 'cui_str': 'Self Medication'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0700572', 'cui_str': 'Reduced mobility (finding)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],220.0,0.0305838,"The improvement in treatment compliance with the Practidose Pillbox was not statistically significant, although a positive tendency was observed.","[{'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Morales Suárez-Varela', 'Affiliation': 'Delegación de Salud Córdoba, Córdoba, Spain. teresa.morales.sspa@juntadeandalucia.es'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atencion primaria,['10.1016/j.aprim.2008.07.003']
933,32118602,"Letter to the Editor: The ""Cough Trick"" Reduces Pain During Removal of Closed-suction Drains after Total Knee Arthroplasty: A Randomized Trial.",,2020,,['after Total Knee Arthroplasty'],"['Cough Trick"" Reduces Pain During Removal of Closed-suction Drains', 'Letter to the Editor']",[],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.0531496,,"[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Tiwari', 'Affiliation': 'V. Tiwari, S. Dwidmuthe, S. S. Sahoo, All India Institute of Medical Sciences-Nagpur, Nagpur, Maharashtra, India.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Dwidmuthe', 'Affiliation': ''}, {'ForeName': 'Samrat Smrutiranjan', 'Initials': 'SS', 'LastName': 'Sahoo', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001204']
934,32011369,Reply to the Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],['Intraarticular Tranexamic Acid'],[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.0971855,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001159']
935,32003285,Validation of a Self-Fitting Method for Over-the-Counter Hearing Aids.,"In common practice, hearing aids are fitted by a clinician who measures an audiogram and uses it to generate prescriptive gain and output targets. This report describes an alternative method where users select their own signal processing parameters using an interface consisting of two wheels that optimally map to simultaneous control of gain and compression in each frequency band. The real-world performance of this approach was evaluated via a take-home field trial. Participants with hearing loss were fitted using clinical best practices (audiogram, fit to target, real-ear verification, and subsequent fine tuning). Then, in their everyday lives over the course of a month, participants either selected their own parameters using this new interface (Self group; n = 38) or used the parameters selected by the clinician with limited control (Audiologist Best Practices Group; n = 37). On average, the gain selected by the Self group was within 1.8 dB overall and 5.6 dB per band of that selected by the audiologist. Participants in the Self group reported better sound quality than did those in the Audiologist Best Practices group. In blind sound quality comparisons conducted in the field, participants in the Self group slightly preferred the parameters they selected over those selected by the clinician. Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise. Overall, the results indicate that it is possible for users to select effective amplification parameters by themselves using a simple interface that maps to key hearing aid signal processing parameters.",2020,"Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise.",['Participants with hearing loss'],[],"['sound quality', 'standard clinical measures of hearing aid benefit or speech perception in noise']",[],[],"[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0028263', 'cui_str': 'Noise'}]",,0.0153411,"Finally, there were no differences between groups in terms of standard clinical measures of hearing aid benefit or speech perception in noise.","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Sabin', 'Affiliation': 'Bose Corporation, Framingham, MA, USA.'}, {'ForeName': 'Dianne J', 'Initials': 'DJ', 'LastName': 'Van Tasell', 'Affiliation': 'Bose Corporation, Framingham, MA, USA.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Rabinowitz', 'Affiliation': 'Bose Corporation, Framingham, MA, USA.'}, {'ForeName': 'Sumitrajit', 'Initials': 'S', 'LastName': 'Dhar', 'Affiliation': 'Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL, USA.'}]",Trends in hearing,['10.1177/2331216519900589']
936,32019389,The effects of a dance intervention on somatic symptoms and emotional distress in adolescent girls: A randomized controlled trial.,,2020,,['adolescent girls'],['dance intervention'],['somatic symptoms and emotional distress'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}]","[{'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.122415,,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Duberg', 'Affiliation': 'University Health Care Research Center, Region Örebro County, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Jutengren', 'Affiliation': 'School of Health Sciences, University of Borås, Borås, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hagberg', 'Affiliation': 'University Health Care Research Center, Region Örebro County, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': 'University Health Care Research Center, Region Örebro County, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}]",The Journal of international medical research,['10.1177/0300060520902610']
937,31844922,When is the best time to perform external physical vibration lithecbole (EPVL) after retrograde intrarenal surgery (RIRS): a multi-center study based on randomized controlled trials.,"To determine the best time to perform EPVL treatment by evaluating the efficacy and safety of active stone extraction in treating residual fragments at different time points after RIRS. All participants had renal or upper ureteral stones preoperatively and still had residual stones after receiving RIRS. They were prospectively randomized into four groups: patients in group A received EPVL 3 days after RIRS; patients in group B received EPVL 7 days after RIRS; patients in group C received EPVL 14 days after RIRS; patients in group D did not receive EPVL after RIRS. Follow-up examinations were performed on all participants. The results, including stone size and location, stone-free rate (SFR) and complications, were compared among the groups. There were 176 patients in total. The SFR in groups A, B, C and D were 62.22%, 40.91%, 14.28% and 11.11%, respectively, 7 days after RIRS. At 14 days after RIRS, the SFR was 80%, 59.09%, 42.86% and 26.67% in groups A, B, C and D, respectively. At 28 days after RIRS, the SFR was 91.11%, 84.09%, 76.19% and 51.11% in groups A, B, C and D, respectively. Group A had the highest SFR from 7 to 28 days, and group C had a higher SFR at 28 days after RIRS than group D (P < 0.05). The side effects were less in groups A and B than in group D 28 days after RIRS (P < 0.05). We recommended that the best time to perform EPVL is 3 days after RIRS, because it could achieve a high SFR at any point in time and reduced complications.",2020,The side effects were less in groups A and B than in group D 28 days after RIRS (P < 0.05).,"['176 patients in total', 'All participants had renal or upper ureteral stones preoperatively and still had residual stones after receiving RIRS']","['EPVL', 'EPVL 14\xa0days after RIRS; patients in group D did not receive EPVL', 'external physical vibration lithecbole (EPVL) after retrograde intrarenal surgery (RIRS']","['highest SFR', 'SFR', 'stone size and location, stone-free rate (SFR) and complications', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441838', 'cui_str': 'Group D (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",176.0,0.0340771,The side effects were less in groups A and B than in group D 28 days after RIRS (P < 0.05).,"[{'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China.'}, {'ForeName': 'Changbao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China. xcb1966@126.com.'}, {'ForeName': 'Youzhi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China.'}, {'ForeName': 'Rongjiang', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, The People's Hospital of Huzhou, Huzhou, China.""}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Guangdong Key Laboratory of Urology, Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jiakai', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Urology, The People's Hospital of Huzhou, Huzhou, China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Urology, The Chinese Medicine Hospital of Jiangsu Province, Nanjing, China.'}, {'ForeName': 'Xuehua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, The Chinese Medicine Hospital of Jiangsu Province, Nanjing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Tongji Hospital of Huazhong Science and Technology University, Wuhan, China.'}, {'ForeName': 'Zhangqun', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Urology, The Tongji Hospital of Huazhong Science and Technology University, Wuhan, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Guangdong Key Laboratory of Urology, Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}]",Urolithiasis,['10.1007/s00240-019-01175-5']
938,31880235,Examining the vulnerability of ambivalent young adults to e-cigarette messages.,"This study used a randomized online experiment to understand the interrelationships between e-cigarette benefit and harm perceptions, e-cigarette use ambivalence, and e-cigarette message exposure and perceived effectiveness. A high prevalence of ambivalent attitudes toward e-cigarettes at baseline was reported. Ambivalent individuals reported significantly higher benefits and lower harm perceptions compared to univalent individuals. Contrary to past findings, ambivalence was not responsive to persuasive messages in this study. This study situates e-cigarette use perceptions in a realistic setting. High baseline ambivalence in this study calls for more unequivocal messages from the FDA about the risks of e-cigarette use.",2020,Ambivalent individuals reported significantly higher benefits and lower harm perceptions compared to univalent individuals.,[],[],[],[],[],[],,0.0144775,Ambivalent individuals reported significantly higher benefits and lower harm perceptions compared to univalent individuals.,"[{'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Majmundar', 'Affiliation': 'School of Communication, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Erlinde', 'Initials': 'E', 'LastName': 'Cornelis', 'Affiliation': 'Fowler School of Business, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Meghan Bridgid', 'Initials': 'MB', 'LastName': 'Moran', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Health marketing quarterly,['10.1080/07359683.2019.1680119']
939,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
940,32125980,"Influence of a high-temperature programme on serum, urinary and sweat levels of selenium and zinc.","INTRODUCTION


The effect of hyperthermia on the antioxidant system in the human organism is well known.
AIM


The objective of this study was to observe the effects of heat on the concentration of Se and Zn, elements related to antioxidant systems.
METHODS


Twenty-nine subjects voluntarily participated in this study. They were divided into a control group (CG; n = 14) and an experimental group (EG; n = 15). All of them underwent two incremental tests until exhaustion in normothermia (22 °C, 20-40%RH) and hyperthermia (42 °C, 20-40%RH). EG experienced nine sessions of repeated heat exposure at high temperatures (100 °C, 20%RH) for three weeks (HEHT). After the intervention, the initial measurements were repeated. Urine and blood samples were collected before and after each test. Additionally, sweat samples were collected after tests in hyperthermia.
RESULTS


There were no significant changes in serum. An increase in the elimination of Zn and Se in EG was observed in urine after HEHT (p < .05). The elimination of Zn by sweating decreased after HEHT in EG (p < .05).
CONCLUSIONS


Exposure to heat at high temperatures increases the urinary excretion of Se and Zn.",2020,An increase in the elimination of Zn and Se in EG was observed in urine after HEHT (p < .05).,['Twenty-nine subjects voluntarily participated in this study'],['high-temperature programme'],"['elimination of Zn by sweating', 'serum', 'elimination of Zn and Se in EG', 'serum, urinary and sweat levels of selenium and zinc', 'urinary excretion of Se and Zn', 'Urine and blood samples']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0042037'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0183983,An increase in the elimination of Zn and Se in EG was observed in urine after HEHT (p < .05).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Department of Physiology. School of Sport Sciences. University of Extremadura, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Department of Physiology. School of Sport Sciences. University of Extremadura, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pérez-Quintero', 'Affiliation': 'Department of Physiology. School of Sport Sciences. University of Extremadura, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Physical Education and Sport, Sport Sciences Faculty, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Robles', 'Affiliation': 'Department of Physical Education and Sport, Sport Sciences Faculty, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Department of Physiology. School of Sport Sciences. University of Extremadura, Spain.'}]",Journal of thermal biology,['10.1016/j.jtherbio.2019.102492']
941,31519550,Short-Term Effects of Very-Low-Phosphate and Low-Phosphate Diets on Fibroblast Growth Factor 23 in Hemodialysis Patients: A Randomized Crossover Trial.,"BACKGROUND AND OBJECTIVES


The short-term effects of low-phosphate diets on fibroblast growth factor 23 (FGF23) level and the optimal amount of dietary phosphate restriction in patients undergoing hemodialysis remain unknown.
DESIGN SETTING, PARTICIPANTS, & MEASUREMENTS


This was a randomized, active-controlled trial with a crossover design that included 35 adults with ESKD undergoing thrice-weekly hemodialysis and with a serum phosphate level >5.5 mg/dl or between 3.5 and 5.5 mg/dl with regular phosphate binder use at a hemodialysis unit of tertiary teaching hospital in Taiwan. Subjects were randomized 1:1 to receive a very-low-phosphate diet, with a phosphate-to-protein ratio of 8 mg/g, or a low-phosphate diet, with a phosphate-to-protein ratio of 10 mg/g for 2 days, each with a 5-day washout during which subjects adhered to their usual diet. The primary outcome measure was mean difference in change-from-baseline intact FGF23 level between intervention groups. Secondary outcomes included difference in change-from-baseline serum phosphate, intact parathyroid hormone (PTH), and C-terminal FGF23 level between intervention groups.
RESULTS


There was no significant difference in the mean change-from-baseline in intact FGF23 levels between the two study diets. The very-low-phosphate diet significantly lowered serum phosphate (mean difference, 0.6 mg/dl; 95% confidence interval [95% CI], 0.2 to 1.0;  P =0.002). There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
CONCLUSIONS


Over the 2-day period, the FGF23-lowering effect of the very-low-phosphate diet is similar to that of the low-phosphate diet. The very-low-phosphate diet has an additional phosphate-lowering effect compared with the low-phosphate diet.",2019,"There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
","['Hemodialysis Patients', '35 adults with ESKD undergoing thrice-weekly hemodialysis and with a serum phosphate level >5.5 mg/dl or between 3.5 and 5.5 mg/dl with regular phosphate binder use at a hemodialysis unit of tertiary teaching hospital in Taiwan', 'patients undergoing hemodialysis remain unknown']","['Very-Low-Phosphate and Low-Phosphate Diets', 'low-phosphate diets', 'very-low-phosphate diet, with a phosphate-to-protein ratio of 8 mg/g, or a low-phosphate diet, with a phosphate-to-protein ratio']","['mean difference in change-from-baseline intact FGF23 level', 'intact FGF23 levels', 'serum phosphate', 'change-from-baseline serum phosphate, intact parathyroid hormone (PTH), and C-terminal FGF23 level', 'Fibroblast Growth Factor 23', 'change-from-baseline intact PTH and C-terminal FGF23 levels', 'fibroblast growth factor 23 (FGF23) level']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0452351', 'cui_str': 'Low phosphate diet (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}]",35.0,0.035397,"There were no significant differences in change-from-baseline intact PTH and C-terminal FGF23 levels between the two study diets.
","[{'ForeName': 'Wan-Chuan', 'Initials': 'WC', 'LastName': 'Tsai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, klchien@ntu.edu.tw mia23448@gmail.com.'}, {'ForeName': 'Hon-Yen', 'Initials': 'HY', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Yu-Sen', 'Initials': 'YS', 'LastName': 'Peng', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Shih-Ping', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Yen-Ling', 'Initials': 'YL', 'LastName': 'Chiu', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Ju-Yeh', 'Initials': 'JY', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Hung-Yuan', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Mei-Fen', 'Initials': 'MF', 'LastName': 'Pai', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine.'}, {'ForeName': 'Wan-Yu', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei City, Taiwan.'}, {'ForeName': 'Kuan-Yu', 'Initials': 'KY', 'LastName': 'Hung', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Fang-Yeh', 'Initials': 'FY', 'LastName': 'Chu', 'Affiliation': 'Department of Clinical Pathology, and.'}, {'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Tsai', 'Affiliation': 'Dietary Department, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Kuo-Liong', 'Initials': 'KL', 'LastName': 'Chien', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei City, Taiwan; klchien@ntu.edu.tw mia23448@gmail.com.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.04250419']
942,32434884,HIV RNA Rebound in Seminal Plasma after Antiretroviral Treatment Interruption.,"If strategies currently in development succeed in eradicating HIV reservoirs in peripheral blood and lymphoid tissues, residual sources of virus may remain in anatomic compartments. Paired blood and semen samples were collected from 12 individuals enrolled in a randomized, double-blind, placebo-controlled therapeutic vaccine clinical trial in people with HIV (PWH) who began antiretroviral therapy (ART) during acute or early infection (ClinicalTrials registration no. NCT01859325). After the week 56 visit (postintervention), all participants interrupted ART. At the first available time points after viral rebound, we sequenced HIV-1  env  (C2-V3),  gag  (p24), and  pol  (reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma using the MiSeq Illumina platform. Comprehensive sequence and phylogenetic analyses were performed to evaluate viral population structure, compartmentalization, and viral diversity in blood and seminal plasma. Compared to that in blood, HIV RNA rebound in semen occurred significantly later (median of 66 versus 42 days post-ART interruption,  P  < 0.01) and reached lower levels (median 164 versus 16,090 copies/ml,  P  < 0.01). Three of five participants with available sequencing data presented compartmentalized viral rebound between blood and semen in one HIV coding region. Despite early ART initiation, HIV RNA molecular diversity was higher in semen than in blood in all three coding regions for most participants. Higher HIV RNA molecular diversity in the genital tract (compared to that in blood plasma) and evidence of compartmentalization illustrate the distinct evolutionary dynamics between these two compartments after ART interruption. Future research should evaluate whether the genital compartment might contribute to viral rebound in some PWH interrupting ART. IMPORTANCE  To cure HIV, we likely need to target the reservoirs in all anatomic compartments. Here, we used sophisticated statistical and phylogenetic methods to analyze blood and semen samples collected from 12 persons with HIV who began antiretroviral therapy (ART) during very early HIV infection and who interrupted their ART as part of a clinical trial. First, we found that HIV RNA rebound in semen occurred significantly later and reached lower levels than in blood. Second, we found that the virus in semen was genetically different in some participants compared to that in blood. Finally, we found increased HIV RNA molecular diversity in semen compared to that in blood in almost all study participants. These data suggest that the HIV RNA populations emerging from the genital compartment after ART interruption might not be the same as those emerging from blood plasma. Future research should evaluate whether the genital compartment might contribute to viral rebound in some people with HIV (PWH) interrupting ART.",2020,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","['clinical trial in people with HIV (PWH) who began ART during acute or early infection (NCT01859325', '12 individuals enrolled', '12 persons with HIV who began antiretroviral therapy (ART) during very early HIV-infection and who interrupted their ART as part of a clinical trial']","['placebo-controlled therapeutic vaccine', 'antiretroviral therapy (ART']","['sequenced HIV-1  env  ( C2-V3 ),  gag (p24),  and  pol ( reverse transcriptase) regions amplified from cell-free HIV RNA in blood and seminal plasma', 'viral population structure, compartmentalization and viral diversity in blood and seminal plasma', 'HIV RNA rebound in semen', 'blood, HIV RNA rebound in semen', 'HIV RNA molecular diversity']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042210', 'cui_str': 'Vaccine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0017343', 'cui_str': 'ENV gene'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877595', 'cui_str': 'HIV RNA rebound'}]",5.0,0.115519,"Despite early ART initiation, HIV RNA molecular diversity was higher in semen compared to blood in all three coding regions for most participants.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gianella', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA gianella@ucsd.edu.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Chaillon', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Sneller', 'Affiliation': 'National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ignacio', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Milenka V', 'Initials': 'MV', 'LastName': 'Vargas-Meneses', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Caballero', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Ellis', 'Affiliation': 'University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Kovacs', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Benko', 'Affiliation': 'Maple Leaf Medical Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Huibner', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Kaul', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of virology,['10.1128/JVI.00415-20']
943,32434996,Monounsaturated fat rapidly induces hepatic gluconeogenesis and whole-body insulin resistance.,"BACKGROUNDWhile saturated fat intake leads to insulin resistance and nonalcoholic fatty liver, Mediterranean-like diets enriched in monounsaturated fatty acids (MUFA) may have beneficial effects. This study examined effects of MUFA on tissue-specific insulin sensitivity and energy metabolism.METHODSA randomized placebo-controlled cross-over study enrolled 16 glucose-tolerant volunteers to receive either oil (OIL, ~1.18 g/kg), rich in MUFA, or vehicle (VCL, water) on 2 occasions. Insulin sensitivity was assessed during preclamp and hyperinsulinemic-euglycemic clamp conditions. Ingestion of 2H2O/acetaminophen was combined with [6,6-2H2]glucose infusion and in vivo 13C/31P/1H/ex vivo 2H-magnet resonance spectroscopy to quantify hepatic glucose and energy fluxes.RESULTSOIL increased plasma triglycerides and oleic acid concentrations by 44% and 66% compared with VCL. Upon OIL intervention, preclamp hepatic and whole-body insulin sensitivity markedly decreased by 28% and 27%, respectively, along with 61% higher rates of hepatic gluconeogenesis and 32% lower rates of net glycogenolysis, while hepatic triglyceride and ATP concentrations did not differ from VCL. During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.CONCLUSIONA single MUFA-load suffices to induce insulin resistance but affects neither hepatic triglycerides nor energy-rich phosphates. These data indicate that amount of ingested fat, rather than its composition, primarily determines the development of acute insulin resistance.TRIAL REGISTRATIONClinicalTrials.gov NCT01736202.FUNDINGGerman Diabetes Center, German Federal Ministry of Health, Ministry of Culture and Science of the state of North Rhine-Westphalia, German Federal Ministry of Education and Research, German Diabetes Association, German Center for Diabetes Research, Portugal Foundation for Science and Technology, European Regional Development Fund, and Rede Nacional de Ressonancia Magnética Nuclear.",2020,"During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.",['controlled cross-over study enrolled 16 glucose-tolerant volunteers'],"['2H2O/acetaminophen', 'oil (OIL, ~1.18 g/kg), rich in MUFA, or vehicle (VCL, water', 'MUFA', 'placebo']","['insulin stimulation hepatic and whole-body insulin sensitivity', 'hepatic glucose and energy fluxes', 'tissue-specific insulin sensitivity and energy metabolism', 'hepatic gluconeogenesis and whole-body insulin resistance', 'hepatic gluconeogenesis', 'preclamp hepatic and whole-body insulin sensitivity', 'Insulin sensitivity', 'plasma triglycerides and oleic acid concentrations', 'rates of net glycogenolysis, while hepatic triglyceride and ATP concentrations']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1454484', 'cui_str': 'VCL protein, human'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}]",,0.110362,"During insulin stimulation hepatic and whole-body insulin sensitivity were reduced by 21% and 25%, respectively, after OIL ingestion compared with that in controls.","[{'ForeName': 'Theresia', 'Initials': 'T', 'LastName': 'Sarabhai', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Kahl', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Szendroedi', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Markgraf', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Oana-Patricia', 'Initials': 'OP', 'LastName': 'Zaharia', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Barosa', 'Affiliation': 'Centre for Neurosciences and Cell Biology, UC Biotech, Cantanhede, Portugal.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Herder', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Frithjof', 'Initials': 'F', 'LastName': 'Wickrath', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bobrov', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Germany.'}, {'ForeName': 'Jong-Hee', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'John Griffith', 'Initials': 'JG', 'LastName': 'Jones', 'Affiliation': 'Centre for Neurosciences and Cell Biology, UC Biotech, Cantanhede, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}]",JCI insight,['10.1172/jci.insight.134520']
944,32196621,Myo-inositol impact on sperm motility in vagina and evaluation of its effects on foetal development.,"OBJECTIVE


To counteract the arising problem of couple infertility, having good quality gametes is increasingly important. A molecule that seems to be useful to favor this condition is myo-inositol (MI), the most common stereoisomer of the inositol family, involved as second messenger in several cell pathways (osmoregulation, chromatin remodeling, gene expression, etc.). To evaluate this possibility, a treatment with myo-inositol in idiopathic infertile couples was performed in this randomized, placebo-controlled study.
PATIENTS AND METHODS


86 couples were enrolled and randomly assigned to two groups, treated either with MI (Xyminal®, Lo.Li. Pharma Srl, Rome, Italy) or placebo suppositories, to evaluate the effects on sperm motility, cervical mucus quality and pregnancy rate. Moreover, in pregnancy cases, all routine controls on gestation progress and foetal health were performed to confirm the safety of this treatment.
RESULTS


As showed in this study, MI treatment allows an increase of total sperm motility (54.42 ± 8.72) in comparison to placebo group (46.21 ± 5.33). Moreover, MI mildly improves cervical mucus quality and increases the number of pregnancies (18.60%) in comparison to the placebo group (6.97%).
CONCLUSIONS


MI improves sperm motility and cervical mucus quality, increasing the probability of conception. The absence of adverse events both for the mother and the foetus confirmed the safety of this molecule in pregnancy, supporting even more its use for couples seeking pregnancy.",2020,"The absence of adverse events both for the mother and the foetus confirmed the safety of this molecule in pregnancy, supporting even more its use for couples seeking pregnancy.","['86 couples', 'idiopathic infertile couples']","['placebo suppositories', 'placebo', 'MI (Xyminal®, Lo']","['gestation progress and foetal health', 'number of pregnancies', 'sperm motility and cervical mucus quality', 'sperm motility, cervical mucus quality and pregnancy rate', 'total sperm motility', 'probability of conception', 'cervical mucus quality']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600457', 'cui_str': 'Gravidity'}, {'cui': 'C0037848', 'cui_str': 'Sperm Motility'}, {'cui': 'C0007872', 'cui_str': 'Cervical Mucus'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]",86.0,0.0879748,"The absence of adverse events both for the mother and the foetus confirmed the safety of this molecule in pregnancy, supporting even more its use for couples seeking pregnancy.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Montanino Oliva', 'Affiliation': 'Saint Camillus International University of Health Sciences, Rome, Italy. mario.montanino@unicamillus.org.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Buonomo', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Carra', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lippa', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lisi', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202003_20540']
945,31915044,Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial.,"INTRODUCTION


The death of a significant person through suicide is a very difficult experience and can have long-term impact on an individual's psychosocial and physical functioning. However, there are only few studies that have examined the effects of interventions in suicide survivors. In the present study, we examine an online-group intervention for people bereaved by suicide using a group-webinar.
METHODS


The intervention was developed based on focus groups with the target group. The cognitive-behavioral 12-module webinar-based group intervention focuses on suicide bereavement-related themes such as feelings of guilt, stigmatization, meaning reconstruction and the relationship to the deceased. Further, the webinar includes testimonial videos and psychoeducation. The suicide survivors are randomized to the intervention or the waiting list in a group-cluster randomized controlled trial. Primary outcomes are suicidality (Beck Scale for Suicide Ideation) and depression (Beck Depression Inventory-II) and secondary outcomes are symptoms of prolonged grief disorder (Inventory of Complicated Grief-German Version ), posttraumatic stress disorder ( Revised Impact of Event Scale ), stigmatization (Stigma of Suicide and Suicide Survivor ) and posttraumatic cognitions (Posttraumatic Cognitions Inventory).
DISCUSSION


Previous studies of Internet-based interventions for the bereaved were based on writing interventions showing large treatment effects. Little is known about the use of webinars as group interventions. Advantages and challenges of this novel approach of psychological interventions will be discussed.
TRIAL REGISTRATION


German Clinical Trials Register, DRKS00014426. Registered on 12 April 2018.
PROTOCOL VERSION


3, 21.10.2019.",2020,"Primary outcomes are suicidality (Beck Scale for Suicide Ideation) and depression (Beck Depression Inventory-II) and secondary outcomes are symptoms of prolonged grief disorder (Inventory of Complicated Grief-German Version ), posttraumatic stress disorder ( Revised Impact of Event Scale ), stigmatization (Stigma of Suicide and Suicide Survivor ) and posttraumatic cognitions (Posttraumatic Cognitions Inventory).
",['people bereaved by suicide using a group-webinar'],['Online-group intervention'],"['suicidality (Beck Scale\xa0for Suicide Ideation) and depression (Beck Depression Inventory-II) and secondary outcomes are symptoms of prolonged grief disorder (Inventory of Complicated Grief-German Version ), posttraumatic stress disorder ( Revised Impact of Event Scale ), stigmatization (Stigma of Suicide and Suicide Survivor ) and posttraumatic cognitions (Posttraumatic Cognitions Inventory']","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0038330', 'cui_str': 'Stigmatization'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0887863,"Primary outcomes are suicidality (Beck Scale for Suicide Ideation) and depression (Beck Depression Inventory-II) and secondary outcomes are symptoms of prolonged grief disorder (Inventory of Complicated Grief-German Version ), posttraumatic stress disorder ( Revised Impact of Event Scale ), stigmatization (Stigma of Suicide and Suicide Survivor ) and posttraumatic cognitions (Posttraumatic Cognitions Inventory).
","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Medical School Berlin, Calandrellistraße 1-9, 12247, Berlin, Germany. birgit.wagner@medicalschool-berlin.de.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hofmann', 'Affiliation': 'Medical School Berlin, Calandrellistraße 1-9, 12247, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Maaß', 'Affiliation': 'Medical School Berlin, Calandrellistraße 1-9, 12247, Berlin, Germany.'}]",Trials,['10.1186/s13063-019-3891-5']
946,32127653,"Comparison of the effects of 1/10,000 and 1/100,000 concentrations of intracameral epinephrine on corneal endothelium and macular thickness after uncomplicated phacoemulsification.","PURPOSE


To evaluate the changes in the corneal endothelial cell parameters and macular thickness after intraocular application of epinephrine [Formula: see text] and epinephrine[Formula: see text].
METHODS


In this study, 210 eyes from 210 patients with age-related cataracts who underwent uncomplicated surgery were included. For all patients, specular microscopy of the corneal endothelium and macular OCT were performed before surgery and 3 months after the surgery. Patients were divided randomly into three groups: without drug (control group), epinephrine [Formula: see text], and epinephrine[Formula: see text]. Three months after the surgery, specular microscopy of the cornea and macular OCT measurements were performed. Measurements were compared between the three groups. Postoperative measurements were also compared with those measurements obtained before surgery.
RESULTS


All the three groups showed a statistically significant decrease in the endothelial cell density after surgery; the reduction in endothelial cell density in the epinephrine [Formula: see text] group was significantly more than those of the other two groups (P value < 0.001). Hexagonality of endothelial cells was significantly reduced in the three groups after the surgery, the epinephrine [Formula: see text] group had more reduction compared with both other groups (P values < 0.001). All the three groups showed a statistically significant increase in the macular thickness after the surgery (P values < 0.001). The mean increase in the macular thickness in the epinephrine [Formula: see text] group was significantly more than those of the other two groups (P values < 0.05).
CONCLUSION


Toxicity of the drug to many endothelial cell parameters and macula was reduced with decreasing concentration of epinephrine to [Formula: see text].",2020,All the three groups showed a statistically significant increase in the macular thickness after the surgery (P values < 0.001).,"['210 eyes from 210 patients with age-related cataracts who underwent uncomplicated surgery were included', 'uncomplicated phacoemulsification']","['intracameral epinephrine', 'epinephrine [Formula', 'epinephrine']","['corneal endothelium and macular thickness', 'corneal endothelium and macular OCT', 'endothelial cell density', 'Hexagonality of endothelial cells', 'macular thickness', 'Toxicity', 'specular microscopy of the cornea and macular OCT measurements']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036646', 'cui_str': 'Age-related cataract (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0014259', 'cui_str': 'Corneal Endothelium'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4054002', 'cui_str': 'Specular microscopy'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",210.0,0.0387122,All the three groups showed a statistically significant increase in the macular thickness after the surgery (P values < 0.001).,"[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Bamdad', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khalili', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. khalilimr57@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Eye (London, England)",['10.1038/s41433-020-0812-5']
947,32017250,Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults?,"OBJECTIVES


Patient expectations of treatment effects could influence neuropsychological and clinical outcomes in clinical trials of behavioral and lifestyle interventions, which could potentially confound the interpretation of findings. Our aim was to examine whether patient expectancy mediated effectiveness of Mindfulness-Based Stress Reduction (MBSR) for improving cognitive function and clinical outcome.
METHODS


The present study uses data from a single-blind, multi-site, randomized controlled trial comparing MBSR to a health education attention control in older adults with anxiety and/or depressive disorders and subjective cognitive concerns. Using the Credibility and Expectations Questionnaire, we measured expectancy and perceived credibility of the interventions assigned to patients. Using mediational analysis, we examined the influence of expectancy and credibility on two key outcomes: memory performance and clinical global improvement.
RESULTS


Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
CONCLUSION


In this clinical trial, expectancy for improvement did not account for the effectiveness of MBSR on memory performance or clinical outcomes in depressed and anxious older adults. We advise that clinical trials of behavioral and lifestyle interventions for brain health in older adults should measure and test the role of expectancy.",2020,"Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
","['older adults', 'depressed and anxious older adults', 'older adults with anxiety and/or depressive disorders and subjective cognitive concerns']","['behavioral and lifestyle interventions', 'mindfulness training', 'Mindfulness Based Stress Reduction (MBSR) to a health education attention control', 'MBSR', 'Mindfulness Based Stress Reduction']",['Credibility and Expectations Questionnaire (CEQ'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018701'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.056748,"Neither expectancy nor perceived credibility of intervention accounted significantly for MBSR's effectiveness for memory test performance or clinical global improvement.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Nicol', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yingling', 'Affiliation': 'Department of Psychiatry, Healthy Mind Lab, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, CA, USA.'}]",International journal of geriatric psychiatry,['10.1002/gps.5279']
948,32191021,Are currently available biomarkers useful to discriminate CSU patients not controlled by low dose omalizumab maintenance therapy?,"Summary


In patients with Chronic Spontaneous Urticaria (CSU), low dose omalizumab maintenance therapy is effective in about one half of complete, fast responders to the drug. Omalizumab 150 mg/month was given as maintenance therapy to 21 patients with a history of severe CSU showing a complete (UAS7=0) response to the dose of 300 mg/month. After 2 months of such regimen, patients were divided into controlled (n=14; UAS7=0) and not controlled (n=7; UAS7 greater-than 10) and ESR, CRP, total IgE, and D-dimer were measured. The two groups did not differ in any of the biomarkers considered, nor in disease duration or in pre-treatment UAS7 score. The study confirms that it is possible to halve the dose of omalizumab without any loss of efficacy in a subgroup of patients with CSU but that none of the currently available biomarkers is able to predict which patients will lose disease control following omalizumab dose reduction.",2020,"The two groups did not differ in any of the biomarkers considered, nor in disease duration or in pre-treatment UAS7 score.",['patients with chronic spontaneous urticaria (CSU'],"['omalizumab maintenance therapy', 'Omalizumab']",['disease duration or in pre-treatment UAS7 score'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.0185876,"The two groups did not differ in any of the biomarkers considered, nor in disease duration or in pre-treatment UAS7 score.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asero', 'Affiliation': 'Allergology clinic, Clinica San Carlo, Paderno Dugnano, Milan, Italy.'}]",European annals of allergy and clinical immunology,['10.23822/EurAnnACI.1764-1489.139']
949,31845149,"Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men Who Have Sex with Men.","We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (≥ 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (≥ 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.",2020,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","['Hispanic/Latino, black/African-American, and white men who have sex with men (MSM', 'condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (<\u200925\xa0years) and older (≥\u200925\xa0years', 'Younger Hispanic/Latino and black men', 'Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men', 'n\u2009=\u20092665, analytical sample size\u2009=\u20092421', 'Who Have Sex with Men']","['MSM', 'MSM Project (eSTAMP']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",[],[],,0.04104,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA. ymizuno@cdc.gov.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}]",Archives of sexual behavior,['10.1007/s10508-019-01534-8']
950,31845142,"Clinical Value of Multi-Slice Spiral CT Angiography, Colon Imaging, and Image Fusion in the Preoperative Evaluation of Laparoscopic Complete Mesocolic Excision for Right Colon Cancer: a Prospective Randomized Trial.","PURPOSE


To evaluate the clinical value of CT angiography (CTA), CT colonography (CTC), and image fusion in the preoperative evaluation of laparoscopic complete mesocolic excision (CME) for right colon cancer.
METHODS


In this randomized prospective study, 80 patients undergoing laparoscopic CME for right colon cancer were randomly divided into two groups: image fusion [the original images were reconstructed using CTA and CTC, then fused into three-dimensional images of the blood vessels and intestines (n = 40)] and control (without CTA and CTC reconstruction before surgery). All patients underwent plain and enhanced abdominal CT before surgery.
RESULTS


In the image fusion group, the gastrocolic trunk of Henle was present in 33 cases, and its branches originated from the colon vein, right gastroepiploic vein, and superior anterior pancreaticoduodenal vein. Among these patients, 5 exhibited the right gastroepiploic vein and superior anterior pancreaticoduodenal vein; 21 exhibited a gastrointestinal trunk consisting of 2 or 3 branches of the right gastroepiploic vein, right colon vein, and middle colon vein; and 7 exhibited 3 or 4 gastro-pancreatic and colon trunks consisting of the right colon vein, middle colon vein, right gastroepiploic vein, and superior anterior pancreaticoduodenal vein. The correspondence with the anatomy actually observed during surgery was 100%. Compared with the conventional CT group, the duration of the operation in the image fusion group was shorter, with reduced intraoperative bleeding, and more lymph node dissection. There were no significant differences in the incidence of complications and length of hospital stay between the two groups (p > 0.05).
CONCLUSIONS


For laparoscopic CME for right colon cancer, CTA, CTC, and image fusion were effective preoperative evaluation methods, which avoided some unseen dangers in the operation process and led to better therapeutic outcomes.",2020,"There were no significant differences in the incidence of complications and length of hospital stay between the two groups (p > 0.05).
","['80 patients undergoing', 'Right Colon Cancer', 'for right colon cancer']","['plain and enhanced abdominal CT', 'Laparoscopic Complete Mesocolic Excision', 'laparoscopic complete mesocolic excision (CME', 'Multi-Slice Spiral CT Angiography, Colon Imaging, and Image Fusion', 'conventional CT', 'control (without CTA and CTC reconstruction before surgery', 'CT angiography (CTA), CT colonography (CTC', 'laparoscopic CME']","['reduced intraoperative bleeding, and more lymph node dissection', 'incidence of complications and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0860888', 'cui_str': 'CT Scan, Spiral'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0935912', 'cui_str': 'CT Colonography'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",80.0,0.0196454,"There were no significant differences in the incidence of complications and length of hospital stay between the two groups (p > 0.05).
","[{'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China. wuxichen2512@njmu.edu.cn.""}, {'ForeName': 'Zhuiyang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}, {'ForeName': 'Jiazen', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, 68 Zhongshan Road, Jiangsu, 214002, People's Republic of China.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04460-1']
951,32435443,"Self-administration of medication: a pragmatic randomized controlled trial of the impact on dispensing errors, perceptions, and satisfaction.","Background


Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with nurse-led medication dispensing.
Methods


A pragmatic randomized controlled trial was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish.Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses.The primary outcome was the proportion of dispensing errors collected through modified disguised observation of participants and nurses. Dispensing errors were divided into clinical and procedural errors.Secondary outcomes were explored through telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge.
Results


Significantly fewer dispensing errors were observed in the intervention group, with 100 errors/1033 opportunities for error (9.7%), compared with 132 errors/1028 opportunities for error (12.8%) in the control group. The number of clinical errors was significantly reduced, whereas no difference in procedural errors was observed. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group.
Conclusion


In conclusion, the reduced number of dispensing errors in the intervention group, indicate that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction related to medication management at the hospital.",2020,"At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group.
","['Danish cardiology unit', 'Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish', 'Patients aged ⩾\u200918\u2009years capable of SAM were eligible for inclusion']","['Intervention group participants self-administered their medication', 'self-administration of medication (SAM', 'Self-administration of medication', 'SAM']","['reduced number of dispensing errors', 'telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge', 'dispensing errors', 'medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction', 'number of clinical errors', 'proportion of dispensing errors', 'dispensing errors, perceptions, and satisfaction', 'procedural errors']","[{'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0564217', 'cui_str': 'Does not speak'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0911021,"At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group.
","[{'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Randers Regional Hospital, Dronningborg Boulevard 16D, Randers NØ 8930, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Olesen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Clinical Pharmacy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Enemark', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Signe Bredsgaard', 'Initials': 'SB', 'LastName': 'Sørensen', 'Affiliation': 'Medical Department, Cardiology Unit, Randers Regional Hospital, Randers, Midtjylland, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'de Thurah', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",Therapeutic advances in drug safety,['10.1177/2042098620904616']
952,32435445,Reduction of potentially inappropriate medication in the elderly: design of a cluster-randomised controlled trial in German primary care practices (RIME).,"Background


Potentially inappropriate medication (PIM) is considered to have potentially more harmful than beneficial health effects in elderly patients. A German example for a PIM list is the PRISCUS list that has been available since 2010. PIMs are associated with an increased risk of hospitalisation and adverse health outcomes. Furthermore, drug-drug interactions (DDI) may pose additional risks to patients. It is not yet clear how numbers of PIM and DDI can be reduced in community-dwelling seniors in primary care; nor is it clear whether patients would benefit from such deprescribing.
Methods


The cluster-randomised controlled study on the ""Reduction of potentially Inappropriate Medication in the Elderly"" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI. The intervention consists of professional education and training on the reduction of PIM and DDI, and will be offered to either general practitioners (GPs) alone or GPs and their office staff in the experimental study arm. The control group will be offered professional education and training on more general issues of prescribing in the elderly, not specifically addressing PIM or DDI. The primary endpoint is the difference in the proportion of patients with at least one PIM or DDI between the start of the study and study closure after 12 months as compared between intervention and control group. Secondary endpoints include overall mortality, number of hospitalisations during the course of the study, quality of life and costs. Secondary analyses will be explorative, with the cluster randomisation being factored in.
Discussion


The RIME study will contribute to answering the question of whether an intervention based on the PRISCUS list can reduce the proportion of community-dwelling seniors aged ⩾70 years with at least one PIM and/or DDI, and whether this will result in positive health effects, for example, as regards hospitalisations.
Trial registration


The Study has been registered in the German Clinical Trials Register (DRKS) under the number DRKS00003610.",2020,"The cluster-randomised controlled study on the ""Reduction of potentially Inappropriate Medication in the Elderly"" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI.","['German primary care practices (RIME', 'community-dwelling seniors aged ⩾70\u2009years with at least one PIM and/or DDI', 'community-dwelling people of ⩾70\u2009years taking at least one PIM and/or medication inducing at least one dangerous DDI', 'elderly patients']","['professional education and training on the reduction of PIM and DDI, and will be offered to either general practitioners (GPs) alone or GPs', '\n\n\nPotentially inappropriate medication (PIM', 'professional education and training on more general issues of prescribing in the elderly, not specifically addressing PIM or DDI']","['risk of hospitalisation and adverse health outcomes', 'overall mortality, number of hospitalisations during the course of the study, quality of life and costs', 'proportion of patients with at least one PIM or DDI']","[{'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013647', 'cui_str': 'Professional Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}]",,0.0438067,"The cluster-randomised controlled study on the ""Reduction of potentially Inappropriate Medication in the Elderly"" (RIME study) is designed to examine whether an intervention based on the PRISCUS list can lower the proportion of community-dwelling people of ⩾70 years taking at least one PIM and/or medication inducing at least one dangerous DDI.","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Thiem', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Bochum, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilm', 'Affiliation': 'Institute of General Practice, University of Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Greiner', 'Affiliation': 'Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Rudolf', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Universitaetsstrasse 150, Bochum, 44801, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Trampisch', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Bochum, Bochum, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Department of General Practice, University Medical Centre Goettingen, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Theile', 'Affiliation': 'Klinik Susenberg, Zurich, Switzerland.'}, {'ForeName': 'Petra A', 'Initials': 'PA', 'LastName': 'Thürmann', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}]",Therapeutic advances in drug safety,['10.1177/2042098620918459']
953,31270220,Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability.,"OBJECTIVE


To evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo.
METHODS


Patients with episodic migraine (4-14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]-1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only).
RESULTS


Differences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4-6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both  p  < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both  p  < 0.001]). Differences were similar for all domain scores ( p  < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = -6.3 ( p  < 0.001) and -5.2 ( p  = 0.002); EVOLVE-2 = -9.2 and -8.2 (both  p  < 0.001).
CONCLUSIONS


Patients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.",2019,"Differences were similar for all domain scores ( p  < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains.","['patients with migraine treated with', 'Patients with episodic migraine (4-14 monthly migraine headache days', 'patients with migraine']","['placebo', 'galcanezumab (Evaluation of LY2951742', 'galcanezumab', 'galcanezumab or placebo']","['MIDAS LS mean change', 'Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events', 'functioning and reduced disability', 'MSQv2.1 total score least squares (LS) mean change', 'daily functioning and decreased disability', 'patient functioning and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0557390', 'cui_str': 'Productivity at work (finding)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.186155,"Differences were similar for all domain scores ( p  < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains.","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY. ford_janet@lilly.com.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Carter', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Leroux', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'From Eli Lilly and Company (J.H.F., D.W.A., V.S., S.K.A., A.T.-H.), Indianapolis, IN; Sanofi (Q.Z.), Bridgewater, NJ; Elanco (J.N.C.), Greenfield, IN; Department of Neurology (E.L.), University of Calgary, Canada; and Department of Neurology (R.B.L.), Albert Einstein College of Medicine, Bronx, NY.'}]",Neurology,['10.1212/WNL.0000000000007856']
954,32436160,"Effect of orally administered magnesium on postoperative pain level and trismus after surgical removal of the lower third molars: a randomized, double-blind, placebo-controlled trial.","OBJECTIVES


Pain and trismus are the most common postoperative complications following a surgical removal of the lower third molar. This randomized, double-blind, placebo-controlled clinical trial evaluated the effect of orally administrated magnesium on postoperative pain and trismus after surgical removal of the lower third molars.
MATERIALS AND METHODS


The study was conducted on 80 participants who were divided into two groups. Each group took different oral forms of magnesium citrate. Participants in both groups had their two lower molars surgically removed. For one randomly selected third molar, participants received either magnesium citrate tablets or lozenges. For the surgical removal of the lower third molar of the opposite side, the participants received either placebo tablets or lozenges. The data were analyzed using the Wilcoxon signed-ranked test, the Mann-Whitney U test, and the Spearman rank-order correlation with the level of significance set at p < 0.05. This manuscript was written in accordance with the Consort recommendation.
RESULTS


The results show a statistically significant lower pain level at all tested times (24 h, 48 h, and 72 h postoperatively) for participants who used magnesium preparations in lozenges (p = 0.012, p = 0.013, and p ≤ 0.001) as well as in tablet form (p ≤ 0.001) compared to placebo. The results also show a statistically significant greater mouth opening ability at all tested times (24 h, 48 h, and 72 h postoperatively) between magnesium preparations and the placebo (p ≤ 0.001).
CONCLUSION


Orally administered magnesium (either lozenges or tablets) before and after a lower third molar surgical removal significantly reduces pain intensity and the degree of trismus in the postoperative period.
CLINICAL RELEVANCE


Based on the results of the study, oral magnesium could be used in the oral and maxillofacial surgery to reduce postoperative complications after surgical removal of the lower third molars.
TRIAL REGISTRATION


This study is registered on http:clinicaltrials.gov under protocol no. NCT03398382.",2020,"The results show a statistically significant lower pain level at all tested times (24 h, 48 h, and 72 h postoperatively) for participants who used magnesium preparations in lozenges (p = 0.012, p = ","['80 participants who were divided into two groups', 'after surgical removal of the lower third molars']","['magnesium citrate tablets or lozenges', 'magnesium citrate', 'placebo tablets or lozenges', 'magnesium', 'placebo']","['pain level', 'postoperative pain level and trismus', 'pain intensity and the degree of trismus', 'postoperative pain and trismus', 'mouth opening ability']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0126774', 'cui_str': 'magnesium citrate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",80.0,0.633874,"The results show a statistically significant lower pain level at all tested times (24 h, 48 h, and 72 h postoperatively) for participants who used magnesium preparations in lozenges (p = 0.012, p = ","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerkovic', 'Affiliation': 'Department of Maxillofacial Surgery, Study of Dental Medicine, School of Medicine, Clinical Hospital Centre, University of Split, Spinciceva 1, 21000, Split, Croatia. djerkovic@sfzg.hr.'}, {'ForeName': 'Antonija', 'Initials': 'A', 'LastName': 'Tadin', 'Affiliation': 'Department of Restorative Dental Medicine and Endodontics, Study of Dental Medicine, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gavic', 'Affiliation': 'Department for Oral Medicine and Periodontology, Study of Dental Medicine, School of Medicine, University of Split, Split, Croatia.'}, {'ForeName': 'Nada Zorica', 'Initials': 'NZ', 'LastName': 'Vladislavic', 'Affiliation': 'School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Grgic', 'Affiliation': 'School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Darko', 'Initials': 'D', 'LastName': 'Macan', 'Affiliation': 'Department of Maxillofacial and Oral Surgery, School of Dental Medicine, University of Zagreb, University Hospital Dubrava, Zagreb, Croatia.'}]",Clinical oral investigations,['10.1007/s00784-020-03335-z']
955,31937513,Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis.,"OBJECTIVE


The objective of this analysis was to provide a comprehensive analysis of safety data for adjunctive brivaracetam (BRV), an antiepileptic drug (AED) of the racetam class, for treatment of focal seizures in patients with epilepsy.
METHODS


Data were pooled from two phase II, placebo-controlled, double-blind, dose-ranging trials (N01114 [ClinicalTrials.gov: NCT00175929], N01193 [NCT00175825]) and three phase III, placebo-controlled, double-blind, 12-week trials (N01252 [NCT00490035], N01253 [NCT00464269], and N01358 [NCT01261325]) in patients aged ≥16 years with focal seizures, as well as a phase III, placebo-controlled, double-blind, 16-week trial in patients aged ≥16 years with focal or generalized epilepsy (N01254 [NCT00504881]). Data are presented for the approved therapeutic dose range of 50-200 mg/day. Data for BRV administered intravenously (25-150 mg doses) were pooled separately from one phase III trial (N01258 NCT01405508]) and two clinical pharmacology trials (N01256 [Part B] [UCB Pharma, data on file]; EP0007 [NCT01796899]). Adverse events (AEs) of interest were summarized in relevant categories.
RESULTS


The safety pool comprised 1957 patients: 1271 receiving adjunctive BRV and 686 receiving placebo. Overall, the incidence of treatment-emergent adverse events (TEAEs) was 66.9% with BRV versus 62.8% with placebo. The most frequently reported TEAEs with BRV (≥5% of patients) versus placebo were somnolence (13.3% vs. 7.9%), headache (10.5% vs. 11.5%), dizziness (10.0% vs. 7.0%), and fatigue (8.2% vs. 4.2%). Incidence of psychiatric disorder-related TEAEs was 11.3% with BRV versus 8.2% with placebo. Behavioral disorder-related TEAE incidence was low (4.0% with BRV vs. 2.5% with placebo). Irritability was reported in 2.7% of BRV-treated patients vs. 1.5% of patients receiving placebo; anger, aggression, and agitation were each reported by ≤1% of patients receiving BRV. Treatment-emergent adverse events potentially associated with psychosis were psychotic disorder (three patients on BRV vs. two patients on placebo), auditory hallucination, illusion, visual hallucination (one patient each on BRV), epileptic psychosis, and hallucination (one patient each on placebo). No additional safety concerns were identified in patients with intravenous (IV) BRV administration (n = 104).
CONCLUSIONS


These safety data for adjunctive BRV support its acceptable safety and tolerability profile.",2020,Behavioral disorder-related TEAE incidence was low (4.0% with BRV vs. 2.5% with placebo).,"['patients with epilepsy', '1957 patients: 1271 receiving adjunctive BRV and 686 receiving', 'epilepsy', 'patients aged ≥16\u202fyears with focal seizures, as well as a phase III, placebo-controlled, double-blind, 16-week trial in patients aged ≥16\u202fyears with focal or generalized epilepsy (N01254 [NCT00504881']","['placebo', 'adjunctive brivaracetam', 'adjunctive brivaracetam (BRV']","['dizziness', 'Irritability', 'somnolence', 'Safety and tolerability', 'headache', 'Behavioral disorder-related TEAE incidence', 'incidence of treatment-emergent adverse events (TEAEs', 'auditory hallucination, illusion, visual hallucination (one patient each on BRV), epileptic psychosis, and hallucination', 'aggression, and agitation', 'Incidence of psychiatric disorder-related TEAEs', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0233762', 'cui_str': 'Hallucinations, Auditory'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0233763', 'cui_str': 'Hallucinations, Visual'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338658', 'cui_str': 'Epileptic psychosis (disorder)'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",1957.0,0.423204,Behavioral disorder-related TEAE incidence was low (4.0% with BRV vs. 2.5% with placebo).,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: Christian.brandt@mara.de.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Champlain Building, 6410 Rockledge Drive #610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Badalamenti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: vcbadalamenti@aol.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Teresa.Gasalla@ucb.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Whitesides', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: John.Whitesides@ucb.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106864']
956,32435878,Remote Peer Learning Between US and Cambodian Lay Health Workers to Improve Outcomes for Cambodians with Type 2 Diabetes: a Pilot Study.,"BACKGROUND


This paper reports a single-group, pre-post pilot of a peer-learning intervention between community health workers (CHWs) in the USA and Village Health Support Guides (Guides) in Cambodia to improve outcomes for Cambodians with type 2 diabetes (T2D).
METHOD


Two US-based CHWs were trained in a culturally derived cardiometabolic education curriculum called Eat, Walk, Sleep (EWS) and they were also trained in principles of peer learning. They in turn trained five Cambodia-based Guides remotely through videoconference with a phablet in EWS. Finally, Cambodia-based Guides met with 58 patients with diabetes, face-to-face in their villages, monthly for 6 months to deliver EWS. US-based CHWs and Cambodia-based Guides responded to surveys at baseline and post-treatment. Patients responded to surveys and provided blood pressure and blood samples at baseline and post-treatment.
RESULTS


For US-based CHWs, scores on all surveys of diabetes knowledge, self-evaluation, job satisfaction, and information technology improved, though no statistical tests were run due to sample size. For Cambodia-based Guides, all scores on these same measures improved except for job satisfaction. For patients, n = 60 consented, 2 withdrew, and 7 were lost to follow-up leaving n = 51 for analysis. In paired t tests, patients showed significantly decreased A1c, decreased systolic and diastolic blood pressures, improved attitudes toward medicines, and a trend for switching from all-white to part-brown rice. No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
CONCLUSION


If proven effective in a controlled trial, cross-country peer learning could eventually help other diaspora communities.",2020,"No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
","['Cambodian Lay Health Workers', 'Cambodians with Type 2 Diabetes', '58 patients with diabetes', 'Cambodians with type 2 diabetes (T2D']","['peer-learning intervention', 'culturally derived cardiometabolic education curriculum called Eat, Walk, Sleep (EWS) and they were also trained in principles of peer learning']","['systolic and diastolic blood pressures, improved attitudes toward medicines', 'self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed', 'diabetes knowledge, self-evaluation, job satisfaction, and information technology', 'blood pressure and blood samples']","[{'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0021423', 'cui_str': 'Information Sciences'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0231657,"No changes were detected in self-reported physical activity, medication adherence, sleep quality, or frequency or amount of rice consumed.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'University of Connecticut Schools of Dental Medicine and Medicine, 263 Farmington Ave., MC3910, Farmington, CT, 06030, USA. juwagner@uchc.edu.'}, {'ForeName': 'S Megan', 'Initials': 'SM', 'LastName': 'Berthold', 'Affiliation': 'University of Connecticut School of Social Work, Hartford, CT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Buckley', 'Affiliation': 'University of Connecticut School of Pharmacy, Storrs, CT, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bermudez-Millan', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Toan', 'Initials': 'T', 'LastName': 'Ha', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Theanvy', 'Initials': 'T', 'LastName': 'Kuoch', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Sengly', 'Initials': 'S', 'LastName': 'Kong', 'Affiliation': 'Khmer Health Advocates, West Hartford, CT, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Fraser-King', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}, {'ForeName': 'Ien Srey', 'Initials': 'IS', 'LastName': 'Horn', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}, {'ForeName': 'Lim', 'Initials': 'L', 'LastName': 'Keuky', 'Affiliation': 'Cambodian Diabetes Association, Siem Reap, Cambodia.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09896-3']
957,32436173,Evaluation of biochemical and clinical effects of hyaluronic acid on non-surgical periodontal treatment: a randomized controlled trial.,"BACKGROUND


Recent studies reported that hyaluronic acid (HA) has anti-inflammatory, anti-edematous, and anti-bacterial activities in dentistry, particularly in gingival disorders caused by subgingival plaque microorganisms.
AIMS


This study aimed to evaluate the early term effects of HA as an adjunct to scaling and root planing (SRP) on clinical parameters, periodontal inflamed surface area (PISA), and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in periodontitis.
METHODS


A total of 24 periodontitis patients per group were included in this randomized-controlled study. The study population was divided into four groups: in Group 1: SRP+ saline; in Group 2: SRP + HA gel; in Group 3: SRP+ HA mouth rinse; and in Group 4: SRP + HA mouth rinse + HA gingival gel were applied. At baseline and week 4, clinical parameters and PISA were calculated. Also, biochemicals' (ADA, CAT, and GSH) levels were determined by spectrophotometric analysis.
RESULTS


There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05). There was a significant decrease in ADA in GCF and significant increases in CAT and GSH levels after SRP (p < 0.05) in all four groups. The groups that were administered only gel (2nd and 4th) were different from other groups in terms of ADA, CAT, and GSH levels at 1st week (p < 0.05).
CONCLUSION


HA application as an adjunct to SRP did not affect the clinical results, although, in the control sessions following the application, the results were favorable for the biochemical data in gel-applied groups.
TRIAL REGISTRATION


ClinicalTrials.gov.tr (NCT03754010).",2020,There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05).,['24 periodontitis patients per group'],"['SRP+ saline', 'hyaluronic acid (HA', 'SRP\u2009+\u2009HA mouth rinse + HA gingival gel', 'HA', 'scaling and root planing (SRP', 'hyaluronic acid', 'SRP+ HA mouth rinse', 'SRP\u2009+\u2009HA gel']","[""biochemicals' (ADA, CAT, and GSH) levels"", 'clinical parameters, periodontal inflamed surface area (PISA), and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF', 'clinical parameters and PISA', 'CAT and GSH levels', 'ADA in GCF', 'ADA, CAT, and GSH levels']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1276322', 'cui_str': 'Gingival gel'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}]",24.0,0.0471752,There was a statistically significant improvement in clinical parameters and PISA in all four groups in control sessions (p < 0.05).,"[{'ForeName': 'Hacer Sahin', 'Initials': 'HS', 'LastName': 'Aydinyurt', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey. hacersahinay@gmail.com.tr.'}, {'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Akbal', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey.'}, {'ForeName': 'Dicle', 'Initials': 'D', 'LastName': 'Altindal', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Van Yuzuncu Yil University, Campus, 65080, Van, Turkey.'}, {'ForeName': 'Alihan', 'Initials': 'A', 'LastName': 'Bozoglan', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Firat University, Elazig, Turkey.'}, {'ForeName': 'Abdullah Seckin', 'Initials': 'AS', 'LastName': 'Ertugrul', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Halit', 'Initials': 'H', 'LastName': 'Demir', 'Affiliation': 'Faculty of Art and Science, Department of Chemistry, Van Yuzuncu Yil University, Van, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02230-6']
958,16541086,Serotonin transporter polymorphism mediates vulnerability to loss of incentive motivation following acute tryptophan depletion.,"The serotonin (5-HT) system is implicated in incentive motivational processes. The present study utilized the acute tryptophan depletion (ATD) procedure to investigate the effect of temporarily lowering 5-HT synthesis on motivation in healthy volunteers, stratifying the results by allelic variation at the serotonin transporter gene (5-HTTLPR). ATD resulted in a robust reduction in plasma tryptophan concentration. Consistent with a previous study, ATD attenuated motivationally speeded action on the Cued-Reinforcement Reaction Time task. The present investigation revealed that this effect was restricted to volunteers of the ss genotype, whereas ll volunteers exhibited intact motivationally speeded action following ATD (treatment x reinforcement probability x genotype interaction: F1,26=5.8, p=0.024). Furthermore, tryptophan availability to the brain was correlated positively with motivationally speeded action following ATD in the ss genotype group (rho13=0.71, p=0.006), whereas this correlation was negative in the ll genotype group (rho14=-0.60, p=0.023). This is the first study to suggest that allelic variation at the 5-HTTLPR mediates motivational responses to ATD in healthy volunteers. These data indicate that the s allele at the 5-HTTLPR may confer risk for depression via its effect on incentive motivational processing, and highlight the importance of genetic variation in determining individual responses to pharmacological treatments.",2006,"Consistent with a previous study, ATD attenuated motivationally speeded action on the Cued-Reinforcement Reaction Time task.",['healthy volunteers'],['5-HTTLPR'],"['plasma tryptophan concentration', 'Cued-Reinforcement Reaction Time task']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0198303,"Consistent with a previous study, ATD attenuated motivationally speeded action on the Cued-Reinforcement Reaction Time task.","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': ""Department of Psychiatry, Addenbrooke's Hospital, Cambridge, UK, and Helen Wills Neuroscience Institute, University of California, Berkeley, CA, USA. j.roiser@ion.ucl.ac.uk""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Blackwell', 'Affiliation': ''}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rubinsztein', 'Affiliation': ''}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,[]
959,15688090,The subjective and cognitive effects of acute phenylalanine and tyrosine depletion in patients recovered from depression.,"Although there is evidence for the involvement of dopamine (DA) in unipolar depression, no published study has yet used the technique of acute phenylalanine and tyrosine depletion (APTD), a dietary intervention that selectively lowers DA synthesis, in order to investigate the role of DA in mood disturbance. Tyrosine and phenylalanine depleted and placebo amino acid drinks were administered to 20 patients recovered from depression in a double-blind, placebo-controlled, crossover design. Measures included subjective effects, Hamilton Depression Rating Scale scores, and a comprehensive battery of well-validated computerized cognitive tests. APTD induced a substantial reduction in the ratio of plasma tyrosine and phenylalanine to large neutral amino acids. However, relapse of depressive symptoms was not seen. Although performance on most cognitive tests was unaffected, there was a selective effect on decision-making, with APTD causing participants to bet significantly less. In conclusion, These results suggest a specific role for the involvement of DA in reward/punishment processing in humans. While APTD did not induce relapse in any participant, it did cause patients recovered from depression to show lowered sensitivity to reward in a gambling game. It is hypothesized that tests involving reward/punishment processing are preferentially affected by DA depletion, and that a more complete account of depression is likely to result from considering the roles played by serotonin, noradrenaline, and DA in mediating the various cognitive and clinical symptoms, including anhedonia.",2005,"While APTD did not induce relapse in any participant, it did cause patients recovered from depression to show lowered sensitivity to reward in a gambling game.","['20 patients recovered from depression in a double-blind', 'patients recovered from depression']","['dopamine (DA', 'placebo', 'Tyrosine and phenylalanine depleted and placebo amino acid drinks']","['relapse of depressive symptoms', 'subjective effects, Hamilton Depression Rating Scale scores, and a comprehensive battery of well-validated computerized cognitive tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",20.0,0.0417605,"While APTD did not induce relapse in any participant, it did cause patients recovered from depression to show lowered sensitivity to reward in a gambling game.","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': ""Department of Psychiatry, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McLean', 'Affiliation': ''}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Ogilvie', 'Affiliation': ''}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Blackwell', 'Affiliation': ''}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Bamber', 'Affiliation': ''}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Goodyer', 'Affiliation': ''}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,[]
960,31982359,"A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation.","INTRODUCTION


Although premature ejaculation (PE) is a common sexual dysfunction, the available options for PE treatment remain unsatisfactory.
AIM


To evaluate the effect of on-demand oral pregabalin on the intravaginal ejaculation latency time (IELT).
METHOD


We conducted a multiarm double-blinded placebo-controlled randomized clinical trial that enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and C). 4 patients were excluded, 39 patients received 150 mg pregabalin (group A), 39 patients received 75 mg pregabalin (group B), and 38 patients received placebo (group C). All patients were encouraged to engage in sexual relations twice per week for 2 weeks and to take the medication 1-2 hours before sexual intercourse. A stopwatch was used to evaluate IELT.
MAIN OUTCOME MEASURE


The main outcome measure are the improvement of IELT and the reported adverse events.
RESULTS


IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.
CLINICAL IMPLICATIONS


Most PE patients showed a significant improvement after receiving on-demand pregabalin (150 mg).
STRENGTH & LIMITATIONS


The strength of this study is that it is the first randomized controlled trial to evaluate the efficacy of pregabalin in treatment of PE. The main limitations were the small number of patients, IELT was the only primary outcome of the study, and the pregabalin cap can be identified by the patient.
CONCLUSION


Oral pregabalin seems to be a promising drug for additional evaluation as a new treatment for PE. More studies are needed to evaluate the suitable dose, duration, timing, and its safety profile. El Najjar MR, El Hariri M, Ramadan A, et al. A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation. J Sex Med 2020;17:442-446.",2020,"RESULTS


IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.
","['4 patients were excluded, 39 patients received', 'enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and C']","['Placebo', 'demand oral pregabalin', 'multiarm double-blinded placebo', 'pregabalin', 'placebo', '150\xa0mg pregabalin', 'Demand Oral Pregablin']","['improvement of IELT and the reported adverse events', 'Efficacy and Tolerability', 'intravaginal ejaculation latency time (IELT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",120.0,0.0783644,"RESULTS


IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.
","[{'ForeName': 'Mohamed Refaat', 'Initials': 'MR', 'LastName': 'El Najjar', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Hariri', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt. Electronic address: mhaririderma@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramadan', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Abd-Alrahman', 'Initials': 'AA', 'LastName': 'Hefny Hashem', 'Affiliation': 'Dermatology and Venereology Department, Bilbeis Hospital, Al Sharqia, Egypt.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.12.014']
961,16266651,[Costs of spirometry as a screening test for chronic obstructive pulmonary disease in primary care].,"OBJECTIVE


To calculate the costs of COPD screening by simple spirometry, conducted in primary care, in smokers and ex-smokers over 40 years old.
DESIGN


Descriptive study. Cost analysis.
SETTING


Semi-rural health district covering some 6000 inhabitants.
PARTICIPANTS


Randomised sample of 350 smokers and ex-smokers over 40 allocated to the centre. 73 were excluded on SEFAR criteria.
INTERVENTIONS AND MEASUREMENTS


Simple spirometry was conducted with an automatic, portable, dry spirometer. Costs were calculated from the time needed, the material, human resources and the number of valid spirometer readings.
RESULTS


85% of 277 had a spirometry test. 18% of the spirometry readings were not valid. 3 spirometries an hour could be done: at least 1 was pathological and a bronchodilator test was needed. The cost of a spirometry, if a professional devotes 2 hours a day for 5 years, was 10.57 euros or 8.54 euros, for doctor or nurse, respectively. Modifying the number of spirometries per year or the number of professionals trained for such a technique causes only minor changes in cost.
CONCLUSIONS


Optimal cost: 9000 spirometries a year by a single nurse. However, this would entail one nurse's almost exclusive dedication. Two trained professionals raises the cost slightly and distributes the work load better, enabling more hours to be covered. Before advising any COPD screening, its costs and its real possibility of affecting active smokers (the sole preventive possibility) should be carefully assessed.",2005,"Modifying the number of spirometries per year or the number of professionals trained for such a technique causes only minor changes in cost.
","['Semi-rural health district covering some 6000 inhabitants', 'chronic obstructive pulmonary disease in primary care', 'smokers and ex-smokers over 40 years old', '73 were excluded on SEFAR criteria', '350 smokers and ex-smokers over 40 allocated to the centre']",[],[],"[{'cui': 'C0035959'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C3842326', 'cui_str': 'Six thousand'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],[],350.0,0.051625,"Modifying the number of spirometries per year or the number of professionals trained for such a technique causes only minor changes in cost.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ruiz Aguirre', 'Affiliation': 'CAP Joan Vilaplana (Girona-4), Unitat Docent de Medicina de Família i Comunitària de Girona, Girona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vilert Garrofa', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Solanas Saura', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Morera Jordán', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mallorquí Beltrán', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mas Marqués', 'Affiliation': ''}]",Atencion primaria,[]
962,16160709,Methylphenidate ('Ritalin') can ameliorate abnormal risk-taking behavior in the frontal variant of frontotemporal dementia.,"The frontal variant of frontotemporal dementia is a significant neurological condition worldwide. There exist few treatments available for the cognitive and behavioural sequelae of fvFTD. Previous research has shown that these patients display risky decision-making, and numerous studies have now demonstrated pathology affecting the orbitofrontal cortex. The present study uses a within-subjects, double-blind, placebo-controlled procedure to investigate the effects of a single dose of methylphenidate (40 mg) upon a range of different cognitive processes including those assessing prefrontal cortex integrity. Methylphenidate was effective in 'normalizing' the decision-making behavior of patients, such that they became less risk taking on medication, although there were no significant effects on other aspects of cognitive function, including working memory, attentional set shifting, and reversal learning. Moreover, there was an absence of the normal subjective and autonomic responses to methylphenidate seen in elderly subjects. The results are discussed in terms of the 'somatic marker' hypothesis of impaired decision-making following orbitofrontal dysfunction.",2006,"Methylphenidate was effective in 'normalizing' the decision-making behavior of patients, such that they became less risk taking on medication, although there were no significant effects on other aspects of cognitive function, including working memory, attentional set shifting, and reversal learning.",['elderly subjects'],"['methylphenidate', 'Methylphenidate', 'placebo', ""Methylphenidate ('Ritalin""]","['working memory, attentional set shifting, and reversal learning', 'normal subjective and autonomic responses']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728759', 'cui_str': 'Ritalin'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0035375', 'cui_str': 'Reversal Learning'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.0547235,"Methylphenidate was effective in 'normalizing' the decision-making behavior of patients, such that they became less risk taking on medication, although there were no significant effects on other aspects of cognitive function, including working memory, attentional set shifting, and reversal learning.","[{'ForeName': 'Shibley', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Psychiatry, University of Cambridge School of Clinical Medicine, Cambridge, UK.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hodges', 'Affiliation': ''}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Nestor', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,[]
963,16287561,[Effectiveness of advanced group and individual interventions in tackling tobacco dependency in primary care].,"OBJECTIVES


To compare the effectiveness of group advanced intervention and individual advanced intervention for smoking management in primary health care; b) to know if in group intervention exists an added positive effect due of the group and, if this is true, to characterize it; and c) to know the advantages and inconvenients that the participants attribute to each intervention.
DESIGN


Control clinic trial randomized in individual scale.
SETTING


Mallorca primary health centers, Spain.
PARTICIPANTS


Smokers >5 packet-year or monoxid carbon levels >15 ppm prepared for give up smoking. People younger than 18 years, people with terminal illness, and mental problems will be excluded.
INTERVENTIONS


Candidates will be assigned to: a) group intervention; b) individual intervention; or c) short intervention or control group. Interventions will be done by a nurse and a general practitioner. Depth interview will be done for qualitative study. PRINCIPAL MEASUREMENT: Maintained cessation during 12 months confirmed by expired-air carbon monoxide measurement. SECONDARY MEASUREMENTS: Self-declared cessation and confirmed by expired-air carbon monoxide measurement months 1, 2, 3, 6, and 9, and tobacco reduction if there isn't abandonment.
ANALYSIS


Intention treatment. Multilevel analysis will be done to determinate the positive effect added of the group if it's proved that exists. Content analysis for qualitative study.
DISCUSSION


Randomization will prevent participants will be treated by their general practitioner o their nurse, this can mean worse results than results obtained in practice.",2005,Candidates will be assigned to: a) group intervention; b) individual intervention; or c) short intervention or control group.,"['Smokers >5 packet-year or monoxid carbon levels >15 ppm prepared for give up smoking', 'Mallorca primary health centers, Spain', 'primary care', 'People younger than 18 years, people with terminal illness, and mental problems will be excluded']","['group advanced intervention and individual advanced intervention', 'advanced group and individual interventions', 'individual intervention; or c) short intervention or control group']",[],"[{'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C1641805', 'cui_str': 'Packet'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0454825', 'cui_str': 'Mallorca (geographic location)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0679247', 'cui_str': 'Terminal illness (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0776904,Candidates will be assigned to: a) group intervention; b) individual intervention; or c) short intervention or control group.,"[{'ForeName': 'M Ramos', 'Initials': 'MR', 'LastName': 'Montserrat', 'Affiliation': 'Gabinete Técnico, Atención Primaria de Mallorca, Mallorca, España. mramos@ibsalut.caib.es'}]",Atencion primaria,[]
964,30561610,Persistent arterial wall inflammation in patients with elevated lipoprotein(a) despite strong low-density lipoprotein cholesterol reduction by proprotein convertase subtilisin/kexin type 9 antibody treatment.,"AIMS


Subjects with lipoprotein(a) [Lp(a)] elevation have increased arterial wall inflammation and cardiovascular risk. In patients at increased cardiovascular risk, arterial wall inflammation is reduced following lipid-lowering therapy by statin treatment or lipoprotein apheresis. However, it is unknown whether lipid-lowering treatment in elevated Lp(a) subjects alters arterial wall inflammation. We evaluated whether evolocumab, which lowers both low-density lipoprotein cholesterol (LDL-C) and Lp(a), attenuates arterial wall inflammation in patients with elevated Lp(a).
METHODS AND RESULTS


In this multicentre, randomized, double-blind, placebo-controlled study, 129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0 [155.5-301.5] nmol/L [80.0 (62.5-121.0) mg/dL]; mean [standard deviation (SD)] LDL-C 3.7 [1.0] mmol/L [144.0 (39.7) mg/dL]; National Cholesterol Education Program high risk, 25.6%} were randomized to monthly subcutaneous evolocumab 420 mg or placebo. Compared with placebo, evolocumab reduced LDL-C by 60.7% [95% confidence interval (CI) 65.8-55.5] and Lp(a) by 13.9% (95% CI 19.3-8.5). Among evolocumab-treated patients, the Week 16 mean (SD) LDL-C level was 1.6 (0.7) mmol/L [60.1 (28.1) mg/dL], and the median (IQR) Lp(a) level was 188.0 (140.0-268.0) nmol/L [75.2 (56.0-107.2) mg/dL]. Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR)] in the index vessel (left carotid, right carotid, or thoracic aorta) was assessed by 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography. Week 16 index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%) [treatment difference -3.0% (95% CI -7.4% to 1.4%); P = 0.18].
CONCLUSION


Evolocumab treatment in patients with median baseline Lp(a) 200.0 nmol/L led to a large reduction in LDL-C and a small reduction in Lp(a), resulting in persistent elevated Lp(a) levels. The latter may have contributed to the unaltered arterial wall inflammation.",2019,index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%),"['patients with median baseline Lp(a', '129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0', 'Aims\n\n\nSubjects with lipoprotein(a) [Lp(a', 'patients with elevated lipoprotein(a', 'patients with elevated Lp(a']","['subcutaneous evolocumab 420\u2009mg or placebo', 'dL', 'placebo']","['cardiovascular risk, arterial wall inflammation', 'index vessel MDS TBR', 'arterial wall inflammation and cardiovascular risk', 'mean (SD) LDL-C level', 'low-density lipoprotein cholesterol (LDL-C) and Lp(a', 'median (IQR) Lp(a) level', 'Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR', 'LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0507850', 'cui_str': 'Structure of wall of artery (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",129.0,0.615669,index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%),"[{'ForeName': 'Lotte C A', 'Initials': 'LCA', 'LastName': 'Stiekema', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Simone L', 'Initials': 'SL', 'LastName': 'Verweij', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Helina', 'Initials': 'H', 'LastName': 'Kassahun', 'Affiliation': 'Department of Clinical Development, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Department of Clinical Development, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Fenwood Road, Boston, MA, USA.""}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Mani', 'Affiliation': 'Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl, New York, NY, USA.'}, {'ForeName': 'Zahi A', 'Initials': 'ZA', 'LastName': 'Fayad', 'Affiliation': 'Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl, New York, NY, USA.'}]",European heart journal,['10.1093/eurheartj/ehy862']
965,31508861,An Evidence-Based Model for Disseminating-Implementing Coordinated Anxiety Learning and Management in Department of Veterans Affairs' Community-Based Outpatient Clinics.,"PURPOSE


To explore the feasibility and utility of using a workshop, and supervision-consultation plus external facilitation to disseminate and implement cognitive-behavioral therapy in Veterans Affairs (VA) community-based outpatient clinics (CBOCs).
METHODS


This study occurred in the context of a randomized controlled trial aimed at comparing 2 methods for implementing Coordinated Anxiety Learning Management (CALM) in VA CBOCs. A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice. Qualitative data describe training activities and the feasibility and utility of each training phase in addressing challenges to adopting CALM.
FINDINGS


All 3 phases of the model were feasible to use with our sample of CBOC mental health providers. Providers reported challenges learning CALM during the workshop and concerns about not having enough training post-workshop to use CALM in practice. Providers primarily utilized supervision-consultation to tailor CALM to their practice, including learning how to prioritize a target disorder, ""switch"" the focus of treatment to a different disorder when comorbidities were present, and modify CALM sessions to fit shorter treatment visits. Providers primarily utilized external facilitation to further tailor CALM to their practice through implementation (eg, concrete help) and support-oriented help. Key lessons for implementing CALM in CBOCs are presented and discussed.
CONCLUSIONS


Findings provide initial evidence for the feasibility and utility of using each component of a facilitation-enhanced training model to promote CBOC VA providers' implementation of a computer and manual version of CALM in their practice.",2020,"A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice.",['Veterans Affairs (VA) community-based outpatient clinics (CBOCs'],"['implementing Coordinated Anxiety Learning Management (CALM', 'workshop, and supervision-consultation plus external facilitation to disseminate and implement cognitive-behavioral therapy']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0205221', 'cui_str': 'Disseminated (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],,0.0174379,"A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cucciare', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, Arkansas.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Marchant', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, Arkansas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ecker', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Henn', 'Affiliation': 'VA Texas Valley Coastal Bend Health Care System, Harlingen, Texas.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'LeBeau', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Rabalais', 'Affiliation': 'VA North Texas Health Care System, Dallas, Texas.'}, {'ForeName': 'Raphael D', 'Initials': 'RD', 'LastName': 'Rose', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Mason', 'Initials': 'M', 'LastName': 'Qualls', 'Affiliation': 'Harvard South Shore Psychiatry Residency Training Program, Brockton, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Department of Psychology, Anxiety and Depression Research Center, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Traci H', 'Initials': 'TH', 'LastName': 'Abraham', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, Arkansas.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12398']
966,31506240,Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial.,"Parkinson disease (PD) patients frequently experience micrographia and difficulty writing, which could potentially impact their quality of life. This study aimed to determine whether handwriting exercise could improve fine manual motor function in PD. The study was a randomized controlled trial assessing the efficacy of a 4-week handwriting exercise using a newly developed handwriting practice book. The primary endpoint was an improvement in the time used to complete the handwriting test. Secondary endpoints were accuracy of the writing performance, patient's subjective rating scale of their handwriting and a UPDRS part III motor examination. Of a total of 46 subjects, 23 were randomly assigned to the handwriting exercise group. After 4 weeks, the mean time used to complete the test was significantly lower in the exercise group, compared to the control group (143.43 ± 34.02 vs. 175 ± 48.88 s, p = 0.015). Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001). Significant improvements were also observed by assessing the subjective rating scale and the UPDRS part III scores. The 4-week handwriting exercise using the studied handwriting practice book appears to promote an improvement in writing speed and motor function of hands. The optimal duration and frequency of the exercise, the quantity and characteristic of the letters in the handwriting practice book, and the benefits of the exercise in other languages merit further studies.",2020,"Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001).","['Parkinson disease', 'Of a total of 46 subjects']","['handwriting exercise', '4-week handwriting exercise', 'handwriting exercise group']","['functional outcome', 'Mean time used to complete the handwriting test', 'time used to complete the handwriting test', ""accuracy of the writing performance, patient's subjective rating scale of their handwriting and a UPDRS part III motor examination"", 'mean time used to complete the test', 'writing speed and motor function of hands', 'subjective rating scale and the UPDRS part III scores']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",46.0,0.0240727,"Mean time used to complete the handwriting test decreased from the baseline by 16.16% in the exercise group, but increased by 3.63% in the control group (p < 0.001).","[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Vorasoot', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pichet', 'Initials': 'P', 'LastName': 'Termsarasab', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kunlawat', 'Initials': 'K', 'LastName': 'Thadanipon', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Teeratorn', 'Initials': 'T', 'LastName': 'Pulkes', 'Affiliation': 'Division of Neurology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: teeratorn.pul@mahidol.ac.th.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2019.08.119']
967,15546536,[Effectiveness of an intervention to provide information to patients with hypertension as short text messages and reminders sent to their mobile phone (HTA-Alert)].,"OBJECTIVE


To analyze the effect of an intervention to provide information with mobile phone text messages to patients with hypertension on compliance with therapy for hypertension.
DESIGN


Comparative, controlled, multicenter, randomized cluster study.
SETTING


26 primary care health centers in Spain.
PARTICIPANTS


26 researchers were randomized to a control group or an intervention group (52 patients each, for a total of 104 patients). All patients were receiving monotherapy for uncontrolled hypertension.
INTERVENTION


Patients in the control group received their physician's usual interventions. Patients in the intervention group received messages and reminders sent to their mobile phones 2 days per week during 4 months.
MAIN OUTCOME MEASURES


Tablets were counted and blood pressure was measured at the start of the study and 1, 3, and 6 months later. The percentage of compliers, mean percentage of compliance and degree of control of hypertension were compared. The reduction in absolute and relative risk was calculated, as was the number of individuals needed to treat to avoid noncompliance.
RESULTS


The results were evaluated for a total of 67 individuals (34 in the intervention group and 33 in the control group). The rate of compliance was 85.1% (CI, 74.9%-95.3%) overall, 85.7% (CI, 70.5%-100.9%) in the control group and 84.4% in the intervention group (CI, 70.7%-95.3%) (P=NS). Mean percentage compliance was 90.2%+/-16.3% overall, 88.1%+/-20.8% in the control group and 91.9%+/-11.6% in the intervention group (P=NS). The percentage of patients whose hypertension was controlled at the end of the study was 51.5% (CI, 34.4%-68.6%) in the control group and 64.7% (CI, 48.6%-80.8%) in the intervention group (P=NS).
CONCLUSIONS


The telephone messaging intervention with alerts and reminders sent to mobile phones did not improve compliance with therapy in patients with hypertension.",2004,The telephone messaging intervention with alerts and reminders sent to mobile phones did not improve compliance with therapy in patients with hypertension.,"['patients with hypertension on compliance with therapy for hypertension', '67 individuals (34 in the intervention group and 33 in the control group', '26 researchers', '26 primary care health centers in Spain', 'patients with hypertension']","['mobile phone text messages', 'telephone messaging intervention with alerts and reminders sent to mobile phones did not improve compliance with therapy', ""control group received their physician's usual interventions"", 'monotherapy']","['rate of compliance', 'hypertension', 'Mean percentage compliance', 'percentage of compliers, mean percentage of compliance and degree of control of hypertension', 'blood pressure', 'absolute and relative risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",104.0,0.045051,The telephone messaging intervention with alerts and reminders sent to mobile phones did not improve compliance with therapy in patients with hypertension.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Márquez Contreras', 'Affiliation': 'Centro de Salud La Orden, Huelva, Spain. emarquezc@papps.org'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de la Figuera von Wichmann', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gil Guillén', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ylla-Catalá', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Figueras', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balaña', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Naval', 'Affiliation': ''}]",Atencion primaria,[]
968,31907006,"Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial.","BACKGROUND


People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes.
METHODS/DESIGN


The DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline.
DISCUSSION


The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis.
TRIAL REGISTRATION


ISRCTN, ISRCTN12424842. Registered on 25 February 2015.",2020,A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences.,"['people with First Episode psychosis - Neuroprotection Design (DFEND', 'Patients with an ICD-10 diagnosis of functional psychosis', 'neonates and children', 'people with psychosis', 'early psychosis', 'people with early psychosis']","['vitamin D (cholecalciferol) or a matched placebo', 'Vitamin D supplementation', 'vitamin D supplementation', 'routine vitamin D supplementation', 'placebo']","['assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels', 'total Positive and Negative Syndrome Scale (PANSS) score']","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0598958', 'cui_str': 'Neuronal Protection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C2237119', 'cui_str': 'Assessment of mood (procedure)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.730102,A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences.,"[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Gaughran', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK. fiona.p.gaughran@kcl.ac.uk.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Stringer', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'Deakin University and Barwon Health, Ryrie Street, Geelong, Victoria, 3220, Australia.'}, {'ForeName': 'Shubulade', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.'}, {'ForeName': 'Eromona', 'Initials': 'E', 'LastName': 'Whiskey', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Murray', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Gardner-Sood', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Wojewodka', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ciufolini', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Jordan', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krivoy', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': ""Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Lowe', 'Affiliation': 'Carer Expert and Chair of Trustees, Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Arbuthnott', 'Affiliation': ', London, UK.'}, {'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Clinical Trials Facility, Research Department, Tom Rudd Unit, Moorgreen Hospital, Southampton, SO3 03J, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Boardman', 'Affiliation': 'Cheshire & Wirral Partnership NHS Trust, Churton House, Countess of Chester Health Park, Chester, CH2 1BQ, UK.'}, {'ForeName': 'Mudasir', 'Initials': 'M', 'LastName': 'Firdosi', 'Affiliation': ""South West London and St George's Mental Health NHS Trust, Queen Mary's Hospital, Roehampton Lane, London, SW15 5PN, UK.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McGrath', 'Affiliation': 'Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, 4076, Australia.'}]",Trials,['10.1186/s13063-019-3758-9']
969,31393746,Electromagnetic navigation to assist with computed tomography-guided thermal ablation of liver tumors.,"Purpose:  To evaluate the advantages and primary technical efficacy of an electromagnetic (EM) navigation system for computed tomography (CT)-guided thermal ablation of liver tumors. Material and methods:  From August 2016 to January 2018, 40 patients scheduled for CT- guided thermal ablation were prospectively enrolled and divided into two groups. Twenty patients underwent CT-guided thermal ablation with an EM navigation system (navigation group), while the other 20 patients underwent conventional CT-guided thermal ablation (control group). Data on skin punctures, instrument adjustments, puncture time to target, CT scans, CT fluoroscopy time and dose-length-product (DLP) were compared between the two groups. Any postoperative complications were recorded and the primary technical efficacy was evaluated four to six weeks after the procedure. Results:  All 20 patients in the navigation group successfully underwent EM navigation. Compared to the control group, there were fewer instrument adjustments (mean 2.40 vs. 4.95;  p  = .003), fewer CT scans (mean 7.10 vs. 10.30;  p  = .006), less CT fluoroscopy time (mean 40.47 vs. 59.98 s,  p  = .046), and less DLP (mean 807.39 vs. 1578.67 mGy × cm;  p  = .001). Although not statistically significant, EM navigation resulted in fewer skin punctures (mean 1.20 vs. 1.25;  p  = .803) and slightly longer puncture time to target (mean 16.50 vs. 15.20 min;  p  = .725). No patients experienced major complications and the primary efficacy rate was 90% and 84.21% in the navigation and control groups, respectively ( p  = .661). Conclusions:  EM navigation system optimizes the thermal ablation process and reduces radiation exposure in patients. However, further studies are warranted to determine whether an EM navigation system can improve procedure time, complication rates, and primary technical efficiacy of thermal ablation.",2020,"Although not statistically significant, EM navigation resulted in fewer skin punctures (mean 1.20 vs. 1.25;  p  = .803) and slightly longer puncture time to target (mean 16.50 vs. 15.20 min;  p  = .725).","['liver tumors', 'Twenty patients underwent', 'From August 2016 to January 2018, 40 patients scheduled for CT- guided thermal ablation', 'patients']","['Electromagnetic navigation to assist with computed tomography-guided thermal ablation', 'electromagnetic (EM) navigation system', 'conventional CT-guided thermal ablation (control group', 'CT-guided thermal ablation with an EM navigation system (navigation group', 'EM navigation']","['skin punctures', 'CT fluoroscopy time', 'skin punctures, instrument adjustments, puncture time to target, CT scans, CT fluoroscopy time and dose-length-product (DLP', 'CT scans', 'puncture time', 'primary efficacy rate', 'procedure time, complication rates', 'major complications', 'DLP', 'postoperative complications']","[{'cui': 'C0023903', 'cui_str': 'Neoplasms, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",40.0,0.0214266,"Although not statistically significant, EM navigation resulted in fewer skin punctures (mean 1.20 vs. 1.25;  p  = .803) and slightly longer puncture time to target (mean 16.50 vs. 15.20 min;  p  = .725).","[{'ForeName': 'Zhewei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Shao', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jiaping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Weiyuan', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Interventional Radiology, Zhejiang Cancer Hospital, Hangzhou, China.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2019.1649699']
970,32103495,Omega-3 PUFA and aspirin as adjuncts to periodontal debridement in patients with periodontitis and type 2 diabetes mellitus: Randomized clinical trial.,"BACKGROUND


Supplementation with omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA) have been proposed as a host modulation regimen to control chronic inflammatory diseases. The aim of this study was to investigate the clinical and immunological impact of orally administered ω-3 PUFA and ASA as adjuncts to periodontal debridement for the treatment of periodontitis in patients type 2 diabetes.
METHODS


Seventy-five patients (n = 25/group) were randomly assigned to receive placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) after periodontal debridement (test group [TG]1), or ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) before periodontal debridement (TG2). Periodontal parameters and GCF were collected at baseline (t0), 3 months after periodontal debridement and ω-3 PUFA + ASA or placebo for TG1 and CG (t1), after ω-3 PUFA + ASA (before periodontal debridement) for TG2 (t1), and 6 months after periodontal debridement (all groups) (t2). GCF was analyzed for cytokine levels by multiplex ELISA.
RESULTS


Ten patients (40%) in TG1 and nine patients (36%) in TG2 achieved the clinical endpoint for treatment (less than or equal to four sites with probing depth ≥ 5 mm), as opposed to four (16%) in CG. There was clinical attachment gain in moderate and deep pockets for TG1. IFN-γ and interleukin (IL)-8 levels decreased over time for both test groups. IL-6 levels were lower for TG1. HbA1c levels reduced for TG1.
CONCLUSION


Adjunctive ω-3 and ASA after periodontal debridement provides clinical and immunological benefits to the treatment of periodontitis in patients with type 2 diabetes.",2020,IFN-γ and IL-8 levels decreased over time for both test groups.,"['patients with periodontitis and type 2 diabetes mellitus', 'patients with type 2 diabetes', 'Seventy-five patients (n = 25/group', 'patients type 2 diabetes']","['Omega-3 PUFA and aspirin', 'ω-3 PUFA + ASA or placebo', 'ω-3 PUFA and ASA', 'placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) after periodontal debridement (Test Group [TG]1), or ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) before periodontal debridement (TG2', 'omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA']","['clinical attachment gain', 'HbA1c levels', 'IFN-γ and IL-8 levels', 'IL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.114601,IFN-γ and IL-8 levels decreased over time for both test groups.,"[{'ForeName': 'Nidia C', 'Initials': 'NC', 'LastName': 'Castro Dos Santos', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Naira M R B', 'Initials': 'NMRB', 'LastName': 'Andere', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Cássia F', 'Initials': 'CF', 'LastName': 'Araujo', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'de Marco', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Alpdogan', 'Initials': 'A', 'LastName': 'Kantarci', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, MA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Van Dyke', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, MA, USA.'}, {'ForeName': 'Mauro P', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0613']
971,15100698,Acute ketamine administration alters the brain responses to executive demands in a verbal working memory task: an FMRI study.,"We have used functional MRI to determine the effects of ketamine on brain systems activated in association with a working memory task. Healthy volunteers received intravenous infusions of placebo, ketamine at 50 ng/ml plasma concentration, and ketamine at 100 ng/ml. They were scanned while carrying out a verbal working memory task in which we varied the executive requirements (manipulation vs maintenance processes) and the mnemonic load (three vs five presented letters). We previously showed that ketamine produces a specific behavioral impairment in the manipulation task. In the current study, we modified tasks in order to match performance across drug and placebo conditions, and used an event-related fMRI design, allowing us to remove unsuccessful trials from the analysis. Our results suggest a task-specific effect of ketamine on working memory in a brain system comprising frontal cortex, parietal cortex, and putamen. When subjects are required to manipulate presented letters into alphabetical order, as opposed to maintaining them in the order in which they were presented, ketamine is associated with significantly greater activity in this system, even under these performance-matched conditions. No significant effect of ketamine was seen in association with increasing load. This suggests that our findings are not explicable in terms of a nonspecific effect of ketamine when task difficulty is increased. Rather, our findings provide evidence that the predominant effects of low, subdissociative doses of ketamine are upon the control processes engaged by the manipulation task. Furthermore, we have shown that ketamine's effects may be elucidated by fMRI even when overt behavioral measures show no evidence of impairment.",2004,"Our results suggest a task-specific effect of ketamine on working memory in a brain system comprising frontal cortex, parietal cortex, and putamen.",['Healthy volunteers'],"['Acute ketamine', 'placebo, ketamine', 'ketamine']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.061936,"Our results suggest a task-specific effect of ketamine on working memory in a brain system comprising frontal cortex, parietal cortex, and putamen.","[{'ForeName': 'R A E', 'Initials': 'RA', 'LastName': 'Honey', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Honey', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""O'Loughlin"", 'Affiliation': ''}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Sharar', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kumaran', 'Affiliation': ''}, {'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': ''}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Menon', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Donovan', 'Affiliation': ''}, {'ForeName': 'V C', 'Initials': 'VC', 'LastName': 'Lupson', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bisbrown-Chippendale', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,[]
972,31496270,Improving the Mathematics Performance of Second-Grade Students with Mathematics Difficulties through an Early Numeracy Intervention.,The purpose of this study was to determine the effects of an early numeracy Tier 2 intervention on the mathematics performance of second-grade students with persistent mathematics difficulties. Whole number content and instructional design features were used to boost performance in second-grade early numeracy concepts and skills. Researchers employed a pretest-posttest control group design with randomized assignment of 83 students to the treatment condition and 38 students to the comparison condition. The research team's mathematics interventionists delivered instruction four days per week for 20 weeks to small groups of second-grade students who were identified with persistent mathematics difficulties. Proximal and distal measures were used to determine the effects of the intervention. Findings showed that students in the treatment group outperformed students in the comparison group on the proximal measure of mathematics performance. There were no differences between groups on the problem-solving measures.,2021,There were no differences between groups on the problem-solving measures.,"['second-grade students with persistent mathematics difficulties', '83 students to the treatment condition and 38 students to the comparison condition']",['early numeracy Tier 2 intervention'],['proximal measure of mathematics performance'],"[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0302004,There were no differences between groups on the problem-solving measures.,"[{'ForeName': 'Diane Pedrotty', 'Initials': 'DP', 'LastName': 'Bryant', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, College of Education, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Kathleen Hughes', 'Initials': 'KH', 'LastName': 'Pfannenstiel', 'Affiliation': 'American Institutes for Research, Austin, TX, USA.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Bryant', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, College of Education, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, College of Education, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Anna-Mari', 'Initials': 'AM', 'LastName': 'Fall', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, College of Education, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nozari', 'Affiliation': 'The Meadows Center for Preventing Educational Risk, College of Education, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'University of Wyoming, Laramie, WY, USA.'}]",Behavior modification,['10.1177/0145445519873651']
973,31937335,Efficacy of compatible acupoints and single acupoint versus sham acupuncture for functional dyspepsia: study protocol for a randomized controlled trial.,"BACKGROUND


Acupoint selection is a key factor in the treatment of diseases and has not been well studied. The aim of this trial is to explore the differences in efficacy between compatible acupoints and a single acupoint for patients with functional dyspepsia (FD).
METHODS


This randomized controlled trial will be conducted in the First Affiliated Hospital of Changchun University of Chinese Medicine in China. Two hundred and sixteen FD patients will be randomly assigned to the compatible acupoints group, single acupoint group, or sham acupuncture group. This trial will include a 1-week baseline period, a 4-week treatment period, and a 4-week follow-up period. During the 4-week treatment period, patients will receive 20 sessions of acupuncture (weekly cycles of one session per day for 5 consecutive days followed by a 2-day break). The primary outcome will be a change in the Nepean Dyspepsia Life Quality Index from baseline to after the 4-week treatment period. Secondary outcome measures will include the dyspeptic symptom sum score, Overall Treatment Effect questionnaire, and 36-item Short Form survey. Adverse events also will be recorded. Ultraweak photon emission and metabolomics tests will be performed at baseline and at the end of treatment to explore the mechanisms of the differences between compatible acupoints and a single acupoint.
DISCUSSION


The results of this trial will allow us to compare the difference in efficacy between compatible acupoints and a single acupoint. The findings from this trial will be published in peer-reviewed journals.
TRIAL REGISTRATION


Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-IPC-18000176, registered on 4 March 2019; Chinese Clinical Trial Registry, ChiCTR1900023983, registered on 23 June 2019.",2020,The results of this trial will allow us to compare the difference in efficacy between compatible acupoints and a single acupoint.,"['First Affiliated Hospital of Changchun University of Chinese Medicine in China', 'functional dyspepsia', 'registered on 23 June 2019', 'patients with functional dyspepsia (FD', 'Two hundred and sixteen FD patients']","['compatible acupoints and single acupoint versus sham acupuncture', 'compatible acupoints group, single acupoint group, or sham acupuncture', 'acupuncture', 'compatible acupoints and a single acupoint']","['dyspeptic symptom sum score, Overall Treatment Effect questionnaire, and 36-item Short Form survey', 'Nepean Dyspepsia Life Quality Index', 'Adverse events']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}]","[{'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.341312,The results of this trial will allow us to compare the difference in efficacy between compatible acupoints and a single acupoint.,"[{'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, 130117 China. Department of rehabilitation, Changchun hospital of traditional Chinese medicine, Changchun, 130022, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Jilin Ginseng Academy, Changchun University of Chinese Medicine, Changchun, 130117, China.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Ha', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, 130117, China.'}, {'ForeName': 'Jing-Zhou', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': 'Department of Disease Prevention, First Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, 130021, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Mi', 'Affiliation': 'Department of Endocrinology, First Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, 130021, China.'}, {'ForeName': 'Ping-Hui', 'Initials': 'PH', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Jinlin University, Changchun, 130021, China.'}, {'ForeName': 'Xi-Ying', 'Initials': 'XY', 'LastName': 'Han', 'Affiliation': 'DDepartment of pharmacy, Changchun University of Chinese Medicine, Changchun, 130021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, 130117, China.'}, {'ForeName': 'Jing-Lin', 'Initials': 'JL', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, 130117, China.'}, {'ForeName': 'Fu-Chun', 'Initials': 'FC', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, 130117, China.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, 130117, China. litie1999@126.com.'}]",Trials,['10.1186/s13063-019-3875-5']
974,32436964,Hem-o-lok clips versus intracorporeal knotting for the closure of the appendix stump in laparoscopic appendectomy: A prospective randomized study.,"BACKGROUND


In this study, we aimed to evaluate the superiority of intracorporeal sutures and Hem-o-lok clips about efficiency, reliability and cost.
METHODS


We performed laparoscopic surgery for acute appendicitis in this study. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporeal knotting (Group II) in a randomized manner. Groups were compared for demographic data (age, sex, body mass index, American Society of Anesthesiologists score) operation time, total cost, 2.6.12.24.hours and 7th day pain score.
RESULTS


Demographic data, such as age, gender and BMI, were similar between groups (p>0.05). There was no significant difference between the groups concerning peroperative and postoperative complications (p>0.05). No postoperative nausea, vomiting, ileus and intraabdominal abscess were observed in patients. There was no significant difference between the groups about duration of operation, length of hospital stay and cost analysis (p>0.05). There was no significant difference in pain scores of groups. The effect of the operation type on pain scores was not statistically significant (p>0.05).
CONCLUSION


This study showed that both intracorporeal knotting and Hem-o-loc clips were effective, reliable and similar cost-effective in laparoscopic appendectomy. The decision should be based on the surgeon's experience.",2020,"There was no significant difference between the groups about duration of operation, length of hospital stay and cost analysis (p>0.05).",['laparoscopic appendectomy'],"['Hem-o-lok clips versus intracorporeal knotting', 'Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporeal knotting', 'intracorporeal knotting and Hem-o-loc clips', 'intracorporeal sutures and Hem-o-lok clips', 'laparoscopic surgery']","['duration of operation, length of hospital stay and cost analysis (p>0.05', 'postoperative nausea, vomiting, ileus and intraabdominal abscess', 'pain scores', 'peroperative and postoperative complications']","[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C2711602', 'cui_str': 'Appendiceal stump'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010171', 'cui_str': 'Analysis, Cost'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0230168', 'cui_str': 'Abdominopelvic cavity structure'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.029566,"There was no significant difference between the groups about duration of operation, length of hospital stay and cost analysis (p>0.05).","[{'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ureyen', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Sedat', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Dadalı', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yıldırım', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'İlhan', 'Affiliation': 'Department of General Surgery, Universty of Health Sciences, İzmir Bozyaka Training and Research Hospital, İzmir-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.02248']
975,31846189,Novel topical formulation applied to the nipple-areola complex improves female orgasm.,"BACKGROUND


The nipple-areola complex (NAC) is an often overlooked but important erogenous zone in the female sexual response and sexual functional repertoire. Research suggests that nipple stimulation is significant to female sexual satisfaction in as many as 80% of women. Previously, we have reported that stimulation of the arrector pili muscle in the NAC increases nipple sensitivity and has a positive impact on female sexual function.
AIMS


To study the effect of RJ-101 on female orgasm.
METHODS


A randomized double-blinded placebo-controlled study of RJ101, a novel topical formulation that stimulates the arrector pili muscle of the NAC, in 59 women. Each subject completed a survey composed of Likert scale questions in order to identify changes in orgasm after topical application of RJ101 or placebo.
RESULTS


We demonstrated a positive increase in the perceived intensity of orgasm and orgasmic satisfaction/pleasure in women using RJ101 vs those in the placebo group. After 4 weeks of treatment, 76% of the women in the RJ101 arm reported a positive improvement in satisfaction with orgasm versus 47% in the placebo cohort. The mean change in score for overall satisfaction with orgasm in the RJ101 group was statistically significant (P = .007) compared to placebo.
CONCLUSION


The application of RJ101 to the NAC 30 minutes prior to sexual activity can improve orgasmic strength, pleasure, and satisfaction.",2020,"The mean change in score for overall satisfaction with orgasm in the RJ101 group was statistically significant (P = .007) compared to placebo.
",['59 women'],"['RJ101', 'RJ-101', 'placebo', 'RJ101 or placebo']","['perceived intensity of orgasm and orgasmic satisfaction/pleasure', 'orgasmic strength, pleasure, and satisfaction', 'female sexual satisfaction', 'positive improvement in satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871356', 'cui_str': 'Sexual Satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",59.0,0.140496,"The mean change in score for overall satisfaction with orgasm in the RJ101 group was statistically significant (P = .007) compared to placebo.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krychman', 'Affiliation': 'Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, CA, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Goren', 'Affiliation': 'Applied Biology, Irvine, CA, USA.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Applied Biology, Irvine, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McCoy', 'Affiliation': 'Applied Biology, Irvine, CA, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13262']
976,32103319,"Two apples a day modulate human:microbiome co-metabolic processing of polyphenols, tyrosine and tryptophan.","PURPOSE


Validated biomarkers of food intake (BFIs) have recently been suggested as a useful tool to assess adherence to dietary guidelines or compliance in human dietary interventions. Although many new candidate biomarkers have emerged in the last decades for different foods from metabolic profiling studies, the number of comprehensively validated biomarkers of food intake is limited. Apples are among the most frequently consumed fruits and a rich source of polyphenols and fibers, an important mediator for their health-protective properties.
METHODS


Using an untargeted metabolomics approach, we aimed to identify biomarkers of long-term apple intake and explore how apples impact on the human plasma and urine metabolite profiles. Forty mildly hypercholesterolemic volunteers consumed two whole apples or a sugar and energy-matched control beverage, daily for 8 weeks in a randomized, controlled, crossover intervention study. The metabolome in plasma and urine samples was analyzed via untargeted metabolomics.
RESULTS


We found 61 urine and 9 plasma metabolites being statistically significant after the whole apple intake compared to the control beverage, including several polyphenol metabolites that could be used as BFIs. Furthermore, we identified several endogenous indole and phenylacetyl-glutamine microbial metabolites significantly increasing in urine after apple consumption. The multiomic dataset allowed exploration of the correlations between metabolites modulated significantly by the dietary intervention and fecal microbiota species at genus level, showing interesting interactions between Granulicatella genus and phenyl-acetic acid metabolites. Phloretin glucuronide and phloretin glucuronide sulfate appeared promising biomarkers of apple intake; however, robustness, reliability and stability data are needed for full BFI validation.
CONCLUSION


The identified apple BFIs can be used in future studies to assess compliance and to explore their health effects after apple intake. Moreover, the identification of polyphenol microbial metabolites suggests that apple consumption mediates significant gut microbial metabolic activity which should be further explored.",2020,"We found 61 urine and 9 plasma metabolites being statistically significant after the whole apple intake compared to the control beverage, including several polyphenol metabolites that could be used as BFIs.",['Forty mildly hypercholesterolemic volunteers'],"['Phloretin glucuronide and phloretin glucuronide sulfate', 'food intake (BFIs', 'polyphenols, tyrosine and tryptophan']",['human plasma and urine metabolite profiles'],"[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol (substance)'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042037'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",40.0,0.0191023,"We found 61 urine and 9 plasma metabolites being statistically significant after the whole apple intake compared to the control beverage, including several polyphenol metabolites that could be used as BFIs.","[{'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Ulaszewska', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy. maria.ulaszewska@gmail.com.""}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Koutsos', 'Affiliation': 'Department of Food and Nutritional Sciences, Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research (ICMR), University of Reading, Reading, RG6 6AP, UK.'}, {'ForeName': 'Kajetan', 'Initials': 'K', 'LastName': 'Trošt', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stanstrup', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Garcia-Aloy', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fava', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Fausta', 'Initials': 'F', 'LastName': 'Natella', 'Affiliation': ""Consiglio per la Ricerca in Agricoltura e l'Analisi dell'Economia Agraria (CREA), Food and Nutrition Research Centre, Via Ardeatina 546, 00178, Rome, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Scaccini', 'Affiliation': ""Consiglio per la Ricerca in Agricoltura e l'Analisi dell'Economia Agraria (CREA), Food and Nutrition Research Centre, Via Ardeatina 546, 00178, Rome, Italy.""}, {'ForeName': 'Urska', 'Initials': 'U', 'LastName': 'Vrhovsek', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Tuohy', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lovegrove', 'Affiliation': 'Department of Food and Nutritional Sciences, Hugh Sinclair Unit of Human Nutrition and Institute for Cardiovascular and Metabolic Research (ICMR), University of Reading, Reading, RG6 6AP, UK. j.a.lovegrove@reading.ac.uk.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Via E. Mach 1, San Michele all'Adige, Trentino, Italy. fulvio.mattivi@unitn.it.""}]",European journal of nutrition,['10.1007/s00394-020-02201-8']
977,31502897,"Economic evaluation of a home-based programme to reduce concerns about falls in frail, independently-living older people.","Background : Concerns about falls, or fear of falling, are frequently reported by older people and can have serious consequences. Aim of this study was to evaluate the cost-effectiveness of a home-based, cognitive behavioral programme for independently-living, frail older people in comparison with usual care from a societal perspective.  Methods : This economic evaluation was embedded in a randomized-controlled trial with a follow-up of 12-months. In the trial 389 people aged 70 years or older were allocated to usual care (n = 195) or the intervention group (n = 194). The intervention group received a home-based, cognitive behavioral programme. Main outcome measures were concerns about falls and Quality Adjusted Life Years (QALYs).  Results : Average total costs per participant in the usual care group were 8,094 Euros and 7,890 Euros for participants in the intervention group. The intervention group showed a significant decrease in concerns about falls and a non-significant increase in QALYS in comparison with the usual care group. The probability that the intervention was cost-effective was 75% at a willingness to pay of 20,000 Euros per QALY.  Discussion : The programme is likely to be cost-effective, and therefore a useful addition to current geriatric care, particularly for those persons who are not able or willing to attend group programmes.  Trial registration : NCT01358032.",2020,The intervention group showed a significant decrease in concerns about falls and a non-significant increase in QALYS in comparison with the usual care group.,"['persons who are not able or willing to attend group programmes', 'Discussion ', 'frail, independently-living older people', 'independently-living, frail older people in comparison with usual care from a societal perspective', '389 people aged 70\xa0years or older']","['home-based programme', 'home-based, cognitive behavioral programme', 'usual care']","['cost-effective', 'concerns about falls and Quality Adjusted Life Years (QALYs', 'concerns about falls and a non-significant increase in QALYS', 'cost-effectiveness', 'Average total costs']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",389.0,0.0639789,The intervention group showed a significant decrease in concerns about falls and a non-significant increase in QALYS in comparison with the usual care group.,"[{'ForeName': 'Silvia M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'Department of Health Services Research CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, The Netherlands.'}, {'ForeName': 'Tanja A C', 'Initials': 'TAC', 'LastName': 'Dorresteijn', 'Affiliation': 'Department of Health Services Research CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, The Netherlands.'}, {'ForeName': 'Ben F M', 'Initials': 'BFM', 'LastName': 'Wijnen', 'Affiliation': 'Department of Health Services Research CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, The Netherlands.'}, {'ForeName': 'Jolanda C M', 'Initials': 'JCM', 'LastName': 'van Haastregt', 'Affiliation': 'Department of Health Services Research CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, The Netherlands.'}, {'ForeName': 'Gertrudis I J M', 'Initials': 'GIJM', 'LastName': 'Kempen', 'Affiliation': 'Department of Health Services Research CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, The Netherlands.'}, {'ForeName': 'G A Rixt', 'Initials': 'GAR', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Health Services Research CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, The Netherlands.'}]",Expert review of pharmacoeconomics & outcomes research,['10.1080/14737167.2019.1666714']
978,14436594,"Trial of ""orasecron"" as a pregnancy test.",,1960,,[],[],[],[],[],[],,0.0342835,,"[{'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'RAWLINGS', 'Affiliation': ''}]",The Medical journal of Australia,[]
979,31890682,DM-calendar app as a diabetes self-management education on adult type 2 diabetes mellitus: a randomized controlled trial.,"Purpose


Era Disruption 4.0 demands development in the management of Diabetes Mellitus (DM) by using application-based intervention that can facilitate nursing intervention. The aim was to evaluate the effect of diabetes mellitus calendar app as a Diabetes Self-Management Education (DSME) program on self-efficacy, HbA1c levels, lipid profile, and insulin in adult type 2 diabetes mellitus (T2DM).
Methods


It was randomized experimental design - simple random sampling used with a total sample of 30 respondents. The instruments used diabetes management self-efficacy scales and standard of operational procedure blood sampling. The statistical tests used were a Paired t-test, Wilcoxon, and an Independent t-test.
Results


DSME with an Android-based DM calendar affected self-efficacy ( p  < 0.001), HbA1c levels ( p  = 0.005), cholesterol ( p  = 0.009), triglyceride ( p  = 0.000), HDL-c ( p  = 0.048), LDL-c ( p  = 0.010), and insulin (p = 0.000) compared with the control group. Education with these electronic media has increased the perception of self-efficacy and improved the behavior of good self-management that can be seen from changes in controlled HbA1c level, lipid profile and insulin.
Conclusion


The results of this study can be used as a reference for providing educational experimental in patients with Type 2 Diabetes Mellitus (T2DM).",2019,"Results


DSME with an Android-based DM calendar affected self-efficacy ( p  < 0.001), HbA1c levels ( p  = 0.005), cholesterol ( p  = 0.009), triglyceride ( p  = 0.000), HDL-c ( p  = 0.048), LDL-c ( p  = 0.010), and insulin (p = 0.000) compared with the control group.","['adult type 2 diabetes mellitus', 'patients with Type 2 Diabetes Mellitus (T2DM', 'Diabetes Mellitus (DM', 'adult type 2 diabetes mellitus (T2DM']","['Diabetes Self-Management Education (DSME) program', 'DM-calendar app']","['self-efficacy, HbA1c levels, lipid profile, and insulin', 'triglyceride', 'perception of self-efficacy', 'self-efficacy', 'cholesterol', 'HbA1c levels']","[{'cui': 'C0132254', 'cui_str': 'drebrin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0278405,"Results


DSME with an Android-based DM calendar affected self-efficacy ( p  < 0.001), HbA1c levels ( p  = 0.005), cholesterol ( p  = 0.009), triglyceride ( p  = 0.000), HDL-c ( p  = 0.048), LDL-c ( p  = 0.010), and insulin (p = 0.000) compared with the control group.","[{'ForeName': '', 'Initials': '', 'LastName': 'Kusnanto', 'Affiliation': '1Department of Fundamental, Critical, and Medical-Surgical Nursing, Faculty of Nursing, Universitas Airlangga, Kampus C Mulyorejo, Surabaya, East Java 60115 Indonesia.'}, {'ForeName': 'Komang Agus Jerry', 'Initials': 'KAJ', 'LastName': 'Widyanata', 'Affiliation': '1Department of Fundamental, Critical, and Medical-Surgical Nursing, Faculty of Nursing, Universitas Airlangga, Kampus C Mulyorejo, Surabaya, East Java 60115 Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Suprajitno', 'Affiliation': 'School of Nursing, Patria Husada Blitar, East Java, Indonesia.'}, {'ForeName': 'Hidayat', 'Initials': 'H', 'LastName': 'Arifin', 'Affiliation': '1Department of Fundamental, Critical, and Medical-Surgical Nursing, Faculty of Nursing, Universitas Airlangga, Kampus C Mulyorejo, Surabaya, East Java 60115 Indonesia.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00468-1']
980,30475961,Genetically determined vitamin D levels and change in bone density during a weight-loss diet intervention: the Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) Trial.,"Background


Obesity is closely associated with bone health. Although diet and weight loss produce many metabolic benefits, studies of weight loss diets on bone health are conflicting. Genetic variations, such as vitamin D levels, may partly account for these conflicting observations by regulating bone metabolism.
Objective


We investigated whether the genetic variation associated with vitamin D concentration affected changes in bone mineral density (BMD) in response to a weight-loss diet intervention.
Design


In the 2-y Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) trial, BMD was measured for 424 participants who were randomly assigned to 1 of 4 diets varying in macronutrient intakes. A genetic risk score (GRS) was calculated based on 3 genetic variants [i.e., 7-dehydrocholesterol reductase (DHCR7) rs12785878, cytochrome P450 2R1 (CYP2R1) rs10741657 and group-specific component globulin (GC) rs2282679] related to circulating vitamin D levels. A dual-energy X-ray absorptiometry scan was performed to assess changes in whole-body BMD over 2 y. The final analysis included 370 participants at baseline.
Results


We found a significant interaction between dietary fat intake and vitamin D GRS on 2-y changes in whole-body BMD (P-interaction = 0.02). In the high-fat diet group, participants with higher GRS showed significantly less reduction in whole-body BMD than those with lower GRS, whereas the genetic associations were not significant in the low-fat diet group. We also found a significant interaction between dietary fat intake and the GRS on 6-mo change in femur neck BMD (P-interaction = 0.02); however, the interaction became nonsignificant at 2 y.
Conclusion


Our data indicate that dietary fat intake may modify the effect of vitamin D-related genetic variation on changes in BMD. Overweight or obese patients predisposed to sufficient vitamin D may benefit more in maintaining BMD along with weight loss by eating a low-fat diet. This trial was registered at clinicaltrials.gov as NCT03258203.",2018,"We also found a significant interaction between dietary fat intake and the GRS on 6-mo change in femur neck BMD (P-interaction = 0.02); however, the interaction became nonsignificant at 2 y.
Conclusion


Our data indicate that dietary fat intake may modify the effect of vitamin D-related genetic variation on changes in BMD.","['Overweight or obese patients', '424 participants who were randomly assigned to 1 of 4 diets varying in macronutrient intakes', '370 participants at baseline']","['vitamin D', 'vitamin D GRS', 'weight-loss diet intervention', 'dual-energy X-ray absorptiometry scan']","['femur neck BMD', 'whole-body BMD', 'vitamin D levels and change in bone density', 'bone mineral density (BMD', 'A genetic risk score (GRS']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0012167', 'cui_str': 'Weight Reduction Diet'}, {'cui': 'C1959592', 'cui_str': 'DEXA Scan'}]","[{'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",424.0,0.0430205,"We also found a significant interaction between dietary fat intake and the GRS on 6-mo change in femur neck BMD (P-interaction = 0.02); however, the interaction became nonsignificant at 2 y.
Conclusion


Our data indicate that dietary fat intake may modify the effect of vitamin D-related genetic variation on changes in BMD.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Dianjianyi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': 'Division of Endocrinology, Diabetes, and Hypertension.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': ""Department of Pediatrics, Children's Hospital New Orleans, New Orleans, LA.""}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Pei', 'Affiliation': 'Department of Public Health Laboratory Sciences, West China School of Public Health, Sichuan University, Sichuan Province, China.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqy197']
981,17949629,[Evaluation of a protocol to monitor cardiovascular risk factors in diabetic patients attended in primary care].,"OBJECTIVE


To evaluate a primary care protocol for intensive monitoring of cardiovascular risk (CVR) factors in type-2 diabetes patients versus usual care.
DESIGN


Randomised trial with clusters.
SETTING


Primary care clinics.
PARTICIPANTS


Sixty family physicians.
INTERVENTIONS


Participants were randomised between following a protocol of intensive monitoring of CVR factors and maintaining their habitual practice with DM2 patients. Follow-up lasted 12 months. Data on HbA1C, CVR factors and CVR were collected at the start of the study and at 12 months.
RESULTS


In all, 188 patients (94 intervention group and 94 control group) were included. At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups. At one year, CVR in CG was 33.1% (95% CI, 30%-36.1%) and in IG 30.5% (95% CI, 27.8%-33.2%). The CVR difference between baseline and 1-year measurements was 2.9% (95% CI, 0.2%-5.7%) in CG and 5.4% (95% CI, 2.8%-7.1%) in IG.
CONCLUSIONS


Although improvement of CVR is greater in the IG, the difference between the two groups is not significant. The characteristics of the doctors chosen may have meant that the patients of the two groups received similar treatment.",2007,"At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups.","['type-2 diabetes patients versus usual care', 'Sixty family physicians', '188 patients (94 intervention group and 94 control group) were included', 'Primary care clinics', 'diabetic patients attended in primary care']",[],"['HbA1C, CVR factors and CVR', 'cardiovascular risk factors', 'cardiovascular risk (CVR) factors', 'CVR in CG', 'CVR']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",188.0,0.163506,"At baseline measurement, CVR in control group (CG) was 36.3% (95% CI, 33.9%-38.6%); and in intervention group (IG), 35.9% (95% CI, 33.5%-38.4%), with no significant differences between groups.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gosalbes Soler', 'Affiliation': 'Medicina de Familia, Centro de Salud de Salvador Pau, Valencia, España. gosalbes@comv.es'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Bonet Plá', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchis Doménech', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fornos Garrigós', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fluixá Carrascosa', 'Affiliation': ''}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Ajenjo Navarro', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atencion primaria,[]
982,15033097,[Effectiveness of two health interventions to get pregnant women to give up smoking].,"OBJECTIVE


To evaluate the effectiveness of the group intervention for getting pregnant women to give up tobacco consumption, measured by means of carbon monoxide levels in air breathed out, compared with a minimum intervention.
DESIGN


Randomised clinical trial.
SETTING


Four primary care teams from Area 9 of IMSALUD-Madrid.
PARTICIPANTS


All the pregnant women attending for consultation with the midwives of the four PC teams involved during the study period, who are smoking at least one cigarette a day when they find out they are pregnant and who want to take part in the study once they have been informed of it. Intervention. The subjects included will be randomised into 2 intervention groups. The minimum intervention will consist of brief personal counselling (3 to 5 minutes) on why they should give up smoking, especially now they are pregnant. The group intervention will involve 3 sessions lasting approximately an hour and a half.",2004,"PARTICIPANTS


All the pregnant women attending for consultation with the midwives of the four PC teams involved during the study period, who are smoking at least one cigarette a day when they find out they are pregnant and who want to take part in the study once they have been informed of it.","['All the pregnant women attending for consultation with the midwives of the four PC teams involved during the study period, who are smoking at least one cigarette a day when they find out they are pregnant and who want to take part in the study once they have been informed of it', 'pregnant women to give up smoking', 'Four primary care teams from Area 9 of IMSALUD-Madrid', 'getting pregnant women']",['health interventions'],['carbon monoxide levels'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1998726', 'cui_str': 'Is informed (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.033084,"PARTICIPANTS


All the pregnant women attending for consultation with the midwives of the four PC teams involved during the study period, who are smoking at least one cigarette a day when they find out they are pregnant and who want to take part in the study once they have been informed of it.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blasco Oliete', 'Affiliation': 'Médico de Familia, EAP Humanes, Area 9 IMSALUD, Madrid, España. meliton65@eresmas.com'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sanz Cuesta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Girbés Fontana', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pascual Malanda', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ortiz Valdepeñas', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'García López', 'Affiliation': ''}]",Atencion primaria,[]
983,18093504,[Predictive value of ultra-sound densitometry as a method of selective screening for osteoporosis in primary care].,"OBJECTIVE


To determine the cut-off point of calcaneous quantitative ultrasound densitometry (QUS) as a selection method in primary care for referral of postmenopausal women for dual energy x-ray absorptiometry (DXA).
DESIGN


Diagnostic techniques trial.
SETTING


Four general practices in the Basque Country Autonomous Region, Spain.
PARTICIPANTS


Randomly selected Caucasian women older than 45, chosen at random. A sample size of 146 women was used.
INTERVENTIONS


Calcaneous ultrasound bone mineral density (BMD) measurement, using Achilles Express(R) and DXA.
PRINCIPAL MEASUREMENTS


T-score BMD measurement on both devices. The sensitivity, specificity and positive predictive values of QUS and finally the ideal cut-off value were calculated.
RESULTS


The mean age of the sample was 58.2 (17.7) (range, 48-83 years old). The prevalence of women with osteoporosis, osteopaenia and normal DXA was 14.1%, 50.4% and 35.5%, respectively. The estimated sensitivity of QUS was 78.9% (56.7-91.5) and the specificity was 64.7% (55.6-72.8). The negative predictive value (NPV) was 94.9% (87.7-98.0) and the positive predictive value (PPV) was 26.8% (17.0-39.6). After the COR curve analysis, the ideal cut-off for QUS was determined as a T-score </= -2.0.
CONCLUSIONS


Given its high NPV, QUS can be considered a useful device for screening before DXA. Its low PPV means it has to be combined with other complementary or substitutive selective screening methods, such as predictive rules, which should be evaluated in each specific use.",2007,The estimated sensitivity of QUS was 78.9% (56.7-91.5) and the specificity was 64.7% (55.6-72.8).,"['primary care for referral of postmenopausal women for dual energy x-ray absorptiometry (DXA', 'Randomly selected Caucasian women older than 45, chosen at random', 'Four general practices in the Basque Country Autonomous Region, Spain', 'osteoporosis in primary care', '146 women was used', 'The mean age of the sample was 58.2 (17.7) (range, 48-83 years old']","['Calcaneous ultrasound bone mineral density (BMD', 'ultra-sound densitometry', 'calcaneous quantitative ultrasound densitometry (QUS']","['negative predictive value (NPV', 'prevalence of women with osteoporosis, osteopaenia and normal DXA', 'estimated sensitivity of QUS', 'positive predictive value (PPV', 'T-score BMD measurement', 'sensitivity, specificity and positive predictive values of QUS']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0337796', 'cui_str': 'Basques (ethnic group)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0011321', 'cui_str': 'Densitometry'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",146.0,0.0508439,The estimated sensitivity of QUS was 78.9% (56.7-91.5) and the specificity was 64.7% (55.6-72.8).,"[{'ForeName': 'Eunate', 'Initials': 'E', 'LastName': 'Arana-Arri', 'Affiliation': 'Servicio de Urgencias Generales, Hospital de Cruces, Barakaldo, Bizkaia, España. eunatea@telefonica.net'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Gutiérrez Ibarluzea', 'Affiliation': ''}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Ecenarro Mugaguren', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Asua Batarrita', 'Affiliation': ''}]",Atencion primaria,[]
984,18093505,"[Therapy compliance in cases of hyperlipaemia, as measured through electronic monitors. Is a reminder calendar to avoid forgetfulness effective?].","OBJECTIVE


To analyse the efficacy of the intervention with a calendar reminder of the medication taking in the treatment of the hyperlipidemias.
DESIGN


Controlled, randomised clinical trial.
SETTING


Twelve clinics at 5 primary care centres, Spain.
PARTICIPANTS


Two hundred and twenty people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen.
INTERVENTION


Two groups were formed. The control group (CG) of 110 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 110 patients, who received in addition a calendar remider of medication taking.
MAIN MEASUREMENTS


Meausured of compliance was performed by moniotrs electronic (MEMS) and cholesterol, triglycerides, HDL-C, and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated.
RESULTS


One hundred and eighty eight people (85.45%) completed the survey, 96 in the IG and 92 in the CG; 26.55% were non compliers with the therapy (CI, +/-6.3%) (IG, 10.5%, CI, +/-4.6%; CG, 42.6%, CI, +/-10.1% [P<.0001]). Mean compliance ran at 88,1% (IC, +/-4.6%) overall, at 92% (CI, +/-5.4%) in the IG and at 84% (CI, +/-7.4%) in the IG (P<.05). The RAR was 32.1%, the RRR 75.35%, and the NI was 3.1 patients. The patients with cholesterol controlled ran at 66.7% (CI, +/-9.4%) in the IG and 41.2% in the CG (P<.001).
CONCLUSIONS


The calendar reminder intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment.",2007,"Mean compliance ran at 88,1% (IC, +/-4.6%) overall, at 92% (CI, +/-5.4%) in the IG and at 84% (CI, +/-7.4%) in the IG (P<.05).","['Twelve clinics at 5 primary care centres, Spain', ""110 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 110 patients, who received in addition a calendar remider of medication taking"", 'Two hundred and twenty people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen']",[],"['RAR', 'Meausured of compliance was performed by moniotrs electronic (MEMS) and cholesterol, triglycerides, HDL-C, and LDL-C', 'reduction of absolute and relative risk (RAR and RRR', 'Mean compliance']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C1264195', 'cui_str': 'Refractory anemia with ringed sideroblasts (disorder)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",220.0,0.0503409,"Mean compliance ran at 88,1% (IC, +/-4.6%) overall, at 92% (CI, +/-5.4%) in the IG and at 84% (CI, +/-7.4%) in the IG (P<.05).","[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Márquez Contreras', 'Affiliation': 'Medicina Familiar y Comunitaria, Centro de Salud la Orden, Distrito Huelva-Costa, Huelva, España. emarquezc@papps.org'}, {'ForeName': 'José Joaquín', 'Initials': 'JJ', 'LastName': 'Casado Martínez', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Motero Carrasco', 'Affiliation': ''}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Martín de Pablos', 'Affiliation': ''}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Chaves González', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Losada Ruiz', 'Affiliation': ''}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Pastoriza Vilas', 'Affiliation': ''}]",Atencion primaria,[]
985,16756873,[Effectiveness of an intervention to improve quality care in reducing cardiovascular risk in hypertense patients].,"OBJECTIVE


To evaluate the effectiveness of an intervention on health workers, based on quality improvement through reduction of cardiovascular risk in patients with hypertension.
DESIGN


Quasi-experimental study.
SETTING


Primary care. Two urban health centres.
PARTICIPANTS


A thousand hypertense patients selected by stratified random sampling. One centre (500) was assigned to implement a quality improvement intervention, while at the other centre (500) ""usual care"" procedures were followed (control group).
INTERVENTIONS


The quality improvement intervention consisted of a combined program designed for the medical and nursing staff that comprised audit, feedback, training sessions, and implementation of clinical practice guidelines.
MAIN MEASUREMENTS


Coronary risk using the Framingham scale and cardiovascular mortality risk using the SCORE project.
RESULTS


Absolute coronary risk decreased from 16.94% (95% CI, 15.92-17.66) to 13.81% (95% CI, 13.09-14.52) (P<.001) in the intervention group; whilst there was no significant change in the control group, which dropped from 17.63% (95% CI, 16.68-18.53) to 16.82% (95% CI, 15.91-17.74). The intervention led to a 2.28% point decrease (95% CI, 1.35-3.21) (P<.001) in coronary risk. Cardiovascular mortality risk decreased from 2.48% (95% CI, 2.35-2.62) to 2.19% (95% CI, 2.07-2.31) (P<.001) in the intervention group, with no significant change in the control group, which changed from 2.45% (95% CI, 2.30-2.59) to 2.52% (95% CI, 2.38-2.66). The intervention led to a 0.36% point decrease (95% CI, 0.05-0.73) (P<.001) in cardiovascular mortality risk.
CONCLUSIONS


The quality improvement intervention was effective in decreasing coronary risk and cardiovascular mortality risk in patients with hypertension.",2006,"The intervention led to a 2.28% point decrease (95% CI, 1.35-3.21) (P<.001) in coronary risk.","['Two urban health centres', 'hypertense patients', 'A thousand hypertense patients selected by stratified random sampling', 'patients with hypertension']","['quality improvement intervention, while at the other centre (500) ""usual care"" procedures were followed (control group']","['cardiovascular mortality risk', 'Absolute coronary risk', 'cardiovascular risk', 'Coronary risk using the Framingham scale and cardiovascular mortality risk using the SCORE project', 'Cardiovascular mortality risk', 'coronary risk and cardiovascular mortality risk']","[{'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0780764,"The intervention led to a 2.28% point decrease (95% CI, 1.35-3.21) (P<.001) in coronary risk.","[{'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gómez Marcos', 'Affiliation': 'Centro de Salud de Garrido Sur, Salamanca, España. magomez@usal.es'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'García Ortiz', 'Affiliation': ''}, {'ForeName': 'Luis Javier', 'Initials': 'LJ', 'LastName': 'González Elena', 'Affiliation': ''}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Sánchez Rodríguez', 'Affiliation': ''}]",Atencion primaria,[]
986,17493446,[How does intensive therapy of cardiovascular risk factors affect health-related quality of life in diabetic patients?].,"OBJECTIVE


To assess the health-related quality of life (HRQoL) in diabetic patients who have followed a protocol of intensive treatment of cardiovascular risks (CVR).
DESIGN


Clinical trial randomised by cluster. A convenience sample of 65 primary care practitioners, randomly assigned to a control or intervention group. Patients were selected by systematic sampling from diabetic lists. The follow-up for the control group was by normal practice and the intervention group by using the intensive control of cardiovascular risk factors (CVRF) protocol.
SETTING


Seventeen health-centres in the Valencia Community, Spain.
PARTICIPANTS


One hundred and eighty-four patients, 93 in the control group and 91 in the intervention group.
INCLUSION CRITERIA


patients diagnosed with diabetes mellitus (DM) type 2, aged between 45-75 years, DM for more than 2 years and less than 20 years and a cardiovascular risk (CVR) >20% after 10 years (Framingham equation). The exclusion criteria were: history of ischaemic heart disease, terminal illness, hepatic cirrhosis, renal failure, grade III-IV cardiac failure, and mental disorders. The patients self-completed the Spanish versions of the COOP/WONCA charts and a diabetes-specific tool (ADDQol questionnaire) at the start, and after 6 months and 12 months.
MAIN MEASUREMENTS


Means of COOP/WONCA charts and ADDQol. Comparison between groups using Mann-Whitney U test, and the group follow ups using the Wilcoxon test.
RESULTS


No significant differences were found in the COOP/WONCA charts. At 12 months the only significant difference was in the feelings chart (P=.024; control group 1.86+/-1.03: intervention group 2.23+/-1.11). A negative impact of diabetes was seen in all the dimensions of ADDQoL. The most negative impact of diabetes was related to diet. There were no significant differences between groups in the ADDQoL throughout the study.
CONCLUSIONS


The HRQoL in diabetic patients is not affected by intensive therapy of cardiovascular risk factors. Diabetes has a negative impact on HRQoL in the patients studied.",2007,At 12 months the only significant difference was in the feelings chart (P=.024; control group 1.86+/-1.03: intervention group 2.23+/-1.11).,"['patients diagnosed with diabetes mellitus (DM) type 2, aged between 45-75 years, DM for more than 2 years and less than 20 years and a cardiovascular risk (CVR', 'diabetic patients', 'diabetic patients who have followed a protocol of intensive treatment of cardiovascular risks (CVR', 'Seventeen health-centres in the Valencia Community, Spain', 'The exclusion criteria were: history of ischaemic heart disease, terminal illness, hepatic cirrhosis, renal failure, grade III-IV cardiac failure, and mental disorders', '65 primary care practitioners', 'One hundred and eighty-four patients, 93 in the control group and 91 in the intervention group']",['control or intervention group'],"['diabetes-specific tool (ADDQol questionnaire', 'Means of COOP/WONCA charts and ADDQol', 'health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0679247', 'cui_str': 'Terminal illness (finding)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",184.0,0.0481359,At 12 months the only significant difference was in the feelings chart (P=.024; control group 1.86+/-1.03: intervention group 2.23+/-1.11).,"[{'ForeName': 'M Pilar', 'Initials': 'MP', 'LastName': 'Botija Yagüe', 'Affiliation': 'Medicina Familiar y Comunitaria, Centro de Salud Barrio del Cristo, Departamento 9, Agència Valenciana de Salut, Valencia, España. pilibotija@comv.es'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lizán Tudela', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gosalbes Soler', 'Affiliation': ''}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Bonet Plá', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fornos Garrigós', 'Affiliation': ''}]",Atencion primaria,[]
987,18620635,[Randomized clinical trial for primary care patients with neck pain: manual therapy versus electrical stimulation].,"OBJECTIVE


To compare the effectiveness of manual therapy (MT) versus transcutaneous electrical nervous stimulation (TENS) in reducing the intensity of pain in patients with subacute or chronic neck pain (NP) attended at primary care physiotherapy units (PCPU).
DESIGN


Randomised clinical trial.
SETTING


Thirteen PCPU in 4 health districts of the Community of Madrid, Spain.
PARTICIPANTS


Ninety patients with subacute or chronic NP attended. Lost after intervention: 3.
INTERVENTIONS


At random, 47 patients were allocated to MT treatment and 43 to TENS.
MAIN MEASUREMENTS


Social and demographic characteristics and prognosis variables in the intervention groups were measured. Intensity of pain before and after intervention was calculated by mean values on the analogue visual scale (present moment, average and worst pain of the last 2 weeks). Side-effects were also measured.
RESULTS


Difference between before-and-after pain was 21.83 mm (95% CI, 13.71-29.95) for the group treated with Transcutaneous electrical nervous stimulation and 22.87 mm (95% CI, 17.11-28.64) for manual therapy. The difference in averages on comparing the 2 procedures for improvement was 1.04 (95% CI, -8.66% to 10.75%).
CONCLUSIONS


TENS and MT significantly reduce patients' perceived intensity of pain, although there were no differences between the 2 groups.There are no conclusive results for the alternative physiotherapy treatments that determine a clear strategy of intervention.",2008,"The difference in averages on comparing the 2 procedures for improvement was 1.04 (95% CI, -8.66% to 10.75%).
","['primary care patients with neck pain', '47 patients', 'patients with subacute or chronic neck pain (NP) attended at primary care physiotherapy units (PCPU', 'Ninety patients with subacute or chronic NP attended', 'Thirteen PCPU in 4 health districts of the Community of Madrid, Spain']","['manual therapy (MT) versus transcutaneous electrical nervous stimulation (TENS', 'MT treatment and 43 to TENS', 'electrical stimulation']","['intensity of pain', 'Intensity of pain', 'Side-effects', 'Social and demographic characteristics and prognosis variables']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0454525', 'cui_str': 'Manual Therapies'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",90.0,0.0798047,"The difference in averages on comparing the 2 procedures for improvement was 1.04 (95% CI, -8.66% to 10.75%).
","[{'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Escortell Mayor', 'Affiliation': 'Técnico de Salud de Atención Primaria, Area 3 Alcalá de Henares, Madrid, Spain. eescortell.gapm03@salud.madrid.org'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Lebrijo Pérez', 'Affiliation': ''}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Pérez Martín', 'Affiliation': ''}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Asúnsolo del Barco', 'Affiliation': ''}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Riesgo Fuertes', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Saa Requejo', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atencion primaria,[]
988,18620637,[Effects of a structured exercise programme on cardiovascular risk programmes in post-menopausal women. CLIDERICA study].,"OBJECTIVE


To analyse the influence of a physical exercise programme of strength/stamina on cardiovascular risk factors in low-risk post-menopausal women.
DESIGN


Six-month randomised clinical trial with post-menopausal women.
SETTING


Three health centres in the autonomous community of Murcia, Spain.
PARTICIPANTS


Sixty-three post-menopausal women aged 45 to 59 at low cardiovascular risk. INTERVENTIONS AND MAIN MEASUREMENTS: They were split into 2 groups: a) control: 23 people with no specific intervention, and b) 40 people with an intervention of strength/stamina exercise with protocol for in water and on land. At their initial and final visits, everyone in the 2 groups had anamnesis, physical examination, and general analyses, including Apo A, Apo B, insulin, serum creatinine, creatinine clearance, creatinine in urine, albuminuria, ultrasensitive PCR, and HOMA index.
RESULTS


The insulin levels increased in the control group by 2.02 mU/L and dropped in the experimental group by 0.13 mU/L (P=.021). At the start of the study, creatinine in the control group was 0.83+/-0.12 mg/dL; and at the end, 0.91+/-0.02 mg/dL. In the intervention group it was 0.84+/-0.12 mg/dL at the start and 0.90+/-0.13 mg/dL at the end (NS). Systolic blood pressure dropped in both groups, with a bigger drop in the exercise group (11.81 vs 0.17 mm Hg) (P=.0001). HDL-C values increased in the control group by 4.97 mg/dL; and in the experimental group, by 3.46 mg/dL (NS).
CONCLUSIONS


A controlled programme of strength/stamina physical exercise reduces the cardiovascular risk of post-menopausal women.",2008,The insulin levels increased in the control group by 2.02 mU/L and dropped in the experimental group by 0.13 mU/L (P=.021).,"['post-menopausal women', 'low-risk post-menopausal women', 'Three health centres in the autonomous community of Murcia, Spain', 'Sixty-three post-menopausal women aged 45 to 59 at low cardiovascular risk']","['control: 23 people with no specific intervention, and b) 40 people with an intervention of strength/stamina exercise with protocol for in water and on land', 'strength/stamina physical exercise', 'structured exercise programme', 'physical exercise programme of strength/stamina']","['cardiovascular risk programmes', 'anamnesis, physical examination, and general analyses, including Apo A, Apo B, insulin, serum creatinine, creatinine clearance, creatinine in urine, albuminuria, ultrasensitive PCR, and HOMA index', 'insulin levels', 'cardiovascular risk factors', 'cardiovascular risk', 'Systolic blood pressure', 'HDL-C values']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0021055', 'cui_str': 'Immunological Memory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003592', 'cui_str': 'Apo-A'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0042037'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0574637,The insulin levels increased in the control group by 2.02 mU/L and dropped in the experimental group by 0.13 mU/L (P=.021).,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Saucedo Rodrigo', 'Affiliation': 'Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Abellán Alemán', 'Affiliation': ''}, {'ForeName': 'Purificación', 'Initials': 'P', 'LastName': 'Gómez Jara', 'Affiliation': ''}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Leal Hernández', 'Affiliation': ''}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Ortega Toro', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Colado', 'Affiliation': ''}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Colado Sánchez', 'Affiliation': ''}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Sáinz de Baranda Andújar', 'Affiliation': ''}]",Atencion primaria,[]
989,16266650,[Efficacy of educational sessions to modify the prescription of new drugs].,"OBJECTIVE


To evaluate the efficacy of an educational intervention to minimise the prescription of those new medicines whose therapeutic effects are of little benefit.
DESIGN


Controlled and randomised experimental study.
SETTING


27 health centres in the province of Sevilla, Spain.
PARTICIPANTS


376 general practitioners. The 264 who worked in the same posts were randomised for the 6 pre-intervention months. 10 of them did not complete the post-intervention period.
INTERVENTIONS


Four 45-minute training sessions in a 2-month period, given by health team doctors, with a critical reading of the studies available on recently marketed drugs, plus personal feed-back on prescription and bulletins on therapeutic novelties. The control group received only the feed-back and bulletins.
MAIN MEASUREMENTS


Prescription of new medication of little benefit, measured as the number of packages out of the total. Second, the amount of coxib and eprosartan measured as defined daily doses.
RESULTS


In the 6 months after the educational sessions, the doctors in the intervention group prescribed proportionately fewer therapeutic novelties of little benefit than those allocated to the control group (1.34% vs 1.62%; P<.001). The coxib and eprosartan prescribed showed only a non-significant trend towards less prescription by the intervention group.
CONCLUSIONS


The group educational sessions, run by doctors trained in aspects of evidence-based medicine and prepared jointly with the pharmacy unit, reduced discreetly the prescription of new medicines that were not very innovative.",2005,"The coxib and eprosartan prescribed showed only a non-significant trend towards less prescription by the intervention group.
","['376 general practitioners', '264 who worked in the same posts', '27 health centres in the province of Sevilla, Spain']","['educational intervention', 'educational sessions']","['therapeutic novelties of little benefit', 'Prescription of new medication of little benefit, measured as the number of packages out of the total']","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",376.0,0.03164,"The coxib and eprosartan prescribed showed only a non-significant trend towards less prescription by the intervention group.
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Molina López', 'Affiliation': 'sspa@juntadeandalucia.es'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Domínguez Camacho', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Santos Lozano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Carbonell Carrillo', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sánchez Acevedo', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Paz León', 'Affiliation': ''}]",Atencion primaria,[]
990,12812689,[Group versus individual education for type-2 diabetes patients].,"OBJECTIVES


To compare the effectiveness of group (GE) and individual (IE) health education in type-2 diabetes patients, and identify the improvement in knowledge, metabolic control and risk factors.
DESIGN


Randomised clinical trial.
SETTING


Primary care.Participants. 68 patients with type-2 diabetes, diagnosed 6 months before the start of the study and who had not received GE. Patients aged over 75, those with sensory, psychological and/or physical deficiencies and those not monitored in primary care were excluded (alpha=0.05; beta=0.2).Interventions. Patients were selected according to the inclusion criteria and allocated at random to the IE (n=33) or GE (n=35) group. Individual and group lessons were given at the same time for a year. The contents were evaluated with a validated, self-administered test.
MAIN MEASUREMENTS


General, demographic variables, analyses, blood pressure, the Body Mass Index (BMI), the presence of cardiovascular risk factors, diabetes-related complications and therapeutic variables were all measured.
RESULTS


The two kinds of education showed no significant differences from each other. The two groups improved the level of knowledge (P<0.001), and reduced HbA1c (P<0.001), HDL-C (P<0.001), the BMI (P=0.001) and systolic pressure (P=0.004), and increased their use of reactive strips (P=0.02).
CONCLUSIONS


Health education on diabetes improved knowledge of the disease, metabolic control and cardiovascular risk factors. The two educational methods evaluated were equally effective.",2003,"The two groups improved the level of knowledge (P<0.001), and reduced HbA1c (P<0.001), HDL-C (P<0.001), the BMI (P=0.001) and systolic pressure (P=0.004), and increased their use of reactive strips (P=0.02).
","['type-2 diabetes patients', '68 patients with type-2 diabetes, diagnosed 6 months before the start of the study and who had not received GE', 'Patients were selected according to the inclusion criteria and allocated at random to the IE (n=33) or GE (n=35) group', 'Patients aged over 75, those with sensory, psychological and/or physical deficiencies and those not monitored in primary care']","['individual education', 'group (GE) and individual (IE) health education']","['General, demographic variables, analyses, blood pressure, the Body Mass Index (BMI), the presence of cardiovascular risk factors, diabetes-related complications and therapeutic variables', 'systolic pressure', 'level of knowledge (P<0.001), and reduced HbA1c (P<0.001), HDL-C (P<0.001), the BMI', 'use of reactive strips']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C1321564', 'cui_str': 'Strip'}]",68.0,0.0251735,"The two groups improved the level of knowledge (P<0.001), and reduced HbA1c (P<0.001), HDL-C (P<0.001), the BMI (P=0.001) and systolic pressure (P=0.004), and increased their use of reactive strips (P=0.02).
","[{'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Dalmau Llorca', 'Affiliation': 'Medicina familiar y comunitaria. EAP Temple. ABS Tortosa Est. Institut Català de la Salut. Tarragona. España. rdalmau@ptortosa.scs.es'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'García Bernal', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Aguilar Martín', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Palau Galindo', 'Affiliation': ''}]",Atencion primaria,[]
991,31485965,A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial.,"BACKGROUND


There is a need for new strategies to improve the success of obesity treatment within the primary care setting.
OBJECTIVE


To determine if patients offered low out-of-pocket cost weight management tools achieved more weight loss compared to usual care.
DESIGN


Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital.
PARTICIPANTS


From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention.
INTERVENTIONS


Medical weight management tools-partial meal replacements, recreation center vouchers, pharmacotherapy, commercial weight loss program vouchers, and a group behavioral weight loss program-for $5 or $10 monthly. Patients chose their tools, could switch tools, and could add a second tool at 6 months.
MAIN MEASURES


The primary outcome was the proportion of intervention-eligible patients who achieved ≥ 5% weight loss. The main secondary outcome was the proportion of on-treatment patients who achieved ≥ 5% weight loss.
KEY RESULTS


Overall, 71.3% (305 of 428) had available weight measurement data/PCP visit data to observe the primary outcome. At 12 months, 23.3% (71 of 305) of intervention-eligible participants and 15.7% (415 of 2640) of registry-based comparators had achieved 5% weight loss (p < 0.001). Of the on-treatment participants, 34.5% (39 of 113) achieved 5% weight loss. Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001). The initially preferred tools were meal replacements, pharmacotherapy, and recreation center passes.
CONCLUSIONS


Access to a variety of low out-of-pocket cost weight management tools within primary care resulted in ≥ 5% body weight loss in approximately one quarter of low-income patients with obesity.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT01922934.",2019,Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001).,"['Twelve-month pragmatic clinical weight loss trial with a registry-based comparator group performed in primary care clinics of an urban safety-net hospital', 'From a large clinical registry, we randomly selected 428 patients to have the opportunity to receive the intervention', 'Urban Safety-Net Primary Care Clinics']",[],"['Mean percentage weight loss', 'proportion of on-treatment patients who achieved ≥\u20095% weight loss', 'proportion of intervention-eligible patients who achieved ≥\u20095% weight loss', 'weight loss']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424661', 'cui_str': 'Percentage weight loss (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",428.0,0.0583472,Mean percentage weight loss was - 3.15% ± 6.41% for on-treatment participants and - 0.30% ± 6.10% for comparators (p < 0.001).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Saxon', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA. david.saxon@ucdenver.edu.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Chaussee', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Adam G', 'Initials': 'AG', 'LastName': 'Tsai', 'Affiliation': 'Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Speer', 'Affiliation': 'Denver Health Medical Center, Denver, CO, USA.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Heyn', 'Affiliation': 'Denver Health Medical Center, Denver, CO, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Kealey', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05222-0']
992,15023318,[Impact of a program to improve appropriate prescribing of medications in residential facilities for older persons. Results after one year].,"OBJECTIVE


To evaluate the impact after one year of a program to improve appropriate prescribing of medications, medical care products and supplies at a group of residential centers for older persons.
DESIGN


Multicenter, controlled, quasi-experimental, before-after study of all outpatient prescriptions charged from each center to the Catalonian Health Service during the study period (reference year 2001, monitoring year 2002).
SETTING


A total of 107 residential centers in the Barcelonés Norte y Maresme (Barcelona) health region.
PARTICIPANTS


After situation analysis the centers were divided into two groups: intervention (n=21) and control (n=86). A total of 4789 older persons were residents at participating centers during the study. Interventions. The actions carried out in the intervention group were: a). letter describing the program; b). face-to-face interview to provide information; c). distribution of printed information about the study's aims and the indicators recorded, and d). monitoring with several follow-up interviews.
MAIN MEASURES


We recorded quantitative indicators (general, specific and urinary incontinence products), qualitative indicators (use of medications with high intrinsic pharmacological value and generic pharmaceutical specialties) and relative drug use. The data were analyzed with a program written for Microsoft Access.
RESULTS


In the intervention group we found that pharmaceutical costs were contained, a result we attributed to the greater efficiency achieved with the intervention (interannual increase of 0.7% in the reference period to 16.2% in the monitoring period; P=.000). The contribution of urinary incontinence supplies to cost reductions was noteworthy. Total costs in terms of numbers of packages dispensed for all therapeutic subgroups decreased by 4.8% (P=.000). The use of generic pharmaceutical specialties increased by from 7.9% to 13.1%, and the results for qualitative indictors for antiasthmatics and recommended NSAIDs also revealed improvements in prescribing quality.
CONCLUSIONS


The preliminary results of the program show it to be effective in improving the efficiency of drug prescribing at participating nursing homes. The research method was useful in promoting the rational use of medications and improving the quality of prescribing practices.",2004,Total costs in terms of numbers of packages dispensed for all therapeutic subgroups decreased by 4.8% (P=.000).,"['older persons', 'residential facilities for older persons', 'Multicenter, controlled, quasi-experimental, before-after study of all outpatient prescriptions charged from each center to the Catalonian Health Service during the study period (reference year 2001, monitoring year 2002', 'A total of 107 residential centers in the Barcelonés Norte y Maresme (Barcelona) health region', 'After situation analysis the centers were divided into two groups: intervention (n=21) and control (n=86', '4789 older persons were residents at participating centers during the study']",[],"['prescribing quality', 'Total costs']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",4789.0,0.0172526,Total costs in terms of numbers of packages dispensed for all therapeutic subgroups decreased by 4.8% (P=.000).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sicras Mainar', 'Affiliation': 'Unidad de Farmacia, Región Sanitaria del Barcelonés Norte y Maresme, CatSalut. Badalona, Barcelona, España. asicras@bsa.gs'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Peláez de Loño', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martí López', 'Affiliation': ''}]",Atencion primaria,[]
993,31490251,Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration.,"BACKGROUND


Pectoral nerves (PECS II) block is a popular regional analgesia technique for breast surgery. PECS II block or local infiltration by surgeon may improve outcomes including quality of recovery (QoR).
METHODS


In this multicenter randomized clinical trial, 104 female patients undergoing breast surgery received: (1) PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group). Patients, anesthetists, surgeons, nursing staff, and research assistants were blinded to group allocation. Patients received standardized general anesthesia and multimodal analgesia. The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional) QoR-15 questionnaire measured 24 hours postoperatively. Secondary outcomes were pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible). Randomly assigned groups were compared on outcomes using the Wilcoxon rank-sum test, and the results were reported as median difference with 95% confidence interval.
RESULTS


One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn. Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery. Baseline QoR-15 global scores reported as median [quartiles] were 135 [129, 143] in the PECS group and 139 [127, 143] in the infiltration group. The 24-hour QoR-15 global score reported as median [quartiles] was 131 [116, 140] in the PECS group and 123 [117, 143] in the infiltration group (P = .60), with median difference (95% confidence interval) of -2 (-9 to 5). The median difference reported as infiltration minus PECS for QoR-15 domains was pain 0 (-2 to 1), physical comfort -1 (-3 to 2), physical independence 0 (-2 to 1), psychological support 0 (0-0), and emotions 0 (-1 to 2) (P > .28). The BPI pain subscale at 24 hours (0-40, lower score indicates less pain), reported as median [quartiles], was 7 [2, 13] in the PECS group and 10 [5, 17] in the infiltration group (P = .15). The BPI global score at 24 hours, reported as median [quartiles], was 20 [7, 36] in the PECS group and 23 [10, 43] in the infiltration group (P = .34) and at 3 months was 0 [0, 14] and 0 [0, 11] (P = .85).
CONCLUSIONS


After mostly minor surgery for breast cancer, PECS II block was not superior to local infiltration by the surgeon.",2020,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","['After Breast Surgery', '104 female patients undergoing breast surgery received: (1', 'One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn', 'Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery']","['Pectoral nerves (PECS II) block', 'PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group', 'standardized general anesthesia and multimodal analgesia', 'PECS', 'Pectoral Nerves Interfascial Plane (Pectoral Nerves II']","['QoR-15 questionnaire', 'global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional', 'BPI pain subscale', 'pain', 'quality of recovery (QoR', 'physical comfort -1 (-3 to 2), physical independence 0', 'pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible', 'Baseline QoR-15 global scores', 'Quality of Recovery', '24-hour QoR-15 global score', 'BPI global score']","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4273496', 'cui_str': 'Modified PECS block'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]",104.0,0.164772,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Barrington', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gloria J', 'Initials': 'GJ', 'LastName': 'Seah', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gotmaker', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': ""Pharmacy, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004371']
994,31799694,Are Lactobacillus salivarius G60 and inulin more efficacious to treat patients with oral halitosis and tongue coating than the probiotic alone and placebo? A randomized clinical trial.,"BACKGROUND


The combination of probiotics and prebiotics might be useful to treat oral halitosis. The aim of this study was to assess the effect of Lactobacillus salivarius G60 (LS) and inulin on oral halitosis and tongue coating.
METHODS


In this double-masked, randomized, phase II clinical trial, 45 patients (aged 35 ± 15 years, 66% female) with oral halitosis and tongue coating were allocated to three treatment groups (n = 15) using gums of oral dissolution (one gum every 12 hours) for 10 days. Each gum contained LS (1 billion colony forming units [CFUs]) + inulin (1 g), LS (1 billion CFU) or placebo. Primary outcomes were organoleptic test, Halimeter, and tongue coating, whereas secondary outcomes were quality of life (QOL) and treatment safety. Generalized linear models were used, adjusting for age and sex. In vitro tests were performed to verify whether LS interacts with inulin and whether LS inhibits the growth of Porphyromonas gingivalis and Prevotella intermedia.
RESULTS


Forty-four patients (97%) completed the study. Patients treated with LS + inulin showed greater reduction in halitosis measured by Halimeter compared with placebo (adjusted post-intervention average: 96.7 versus 142.5 ppb; P = 0.003), whereas LS and placebo did not differ (115.7 versus 142.5 ppb; P = 0.097). Organoleptic measurements and coating index showed a similar decrease for all groups. QOL improved in patients treated with LS + inulin compared with placebo (P = 0.029). Side effects were mild and transient in all groups. LS did not metabolize inulin but inhibited the growth of P. gingivalis and P. intermedia after 72 hours.
CONCLUSIONS


Treatment with L. salivarius G60 combined or not with inulin showed significant decrease in the outcomes organoleptic test, Halimeter, and coating index, improving oral halitosis. However, no significant difference was obtained between the groups.",2020,Quality of life improved in patients treated with LS+inulin compared to placebo (p = 0.029).,"['Forty-four patients (97%) completed the study', '45 patients (35 ± 15 years old, 66% female) with oral halitosis and tongue coating']","['placebo', 'Lactobacillus salivarius G60 (LS) and inulin', 'gums of oral dissolution', 'LS+inulin']","['organoleptic test, Halimeter and tongue coating', 'quality of life and treatment safety', 'Organoleptic measurements and coating index', 'reduction in halitosis', 'Quality of life', 'outcomes organoleptic test, Halimeter and coating index, improving oral halitosis', 'Side effects']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018520', 'cui_str': 'Halitosis'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.197802,Quality of life improved in patients treated with LS+inulin compared to placebo (p = 0.029).,"[{'ForeName': 'Camila Rafaela', 'Initials': 'CR', 'LastName': 'Mousquer', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Della Bona', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Daiane Cristina', 'Initials': 'DC', 'LastName': 'Milani', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}, {'ForeName': 'Sidia Maria', 'Initials': 'SM', 'LastName': 'Callegari-Jacques', 'Affiliation': 'Department of Statistics, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Microbiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcia Pinto Alves', 'Initials': 'MPA', 'LastName': 'Mayer', 'Affiliation': 'Department of Microbiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassiano Kuchenbecker', 'Initials': 'CK', 'LastName': 'Rösing', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fornari', 'Affiliation': 'Post Graduate Program in Dentistry, Dental School, University of Passo Fundo, Passo Fundo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0089']
995,14636500,[Do people attending clinics at our health centre know the amount of alcohol consumption that becomes detrimental to health?].,"OBJECTIVES


To evaluate our patients' knowledge of the effects of excess drinking; b) to compare this with their awareness of the effects of their day-to-day drinking habits.
DESIGN


Descriptive, randomized, cross-sectional questionnaire-based study. Information on alcohol consumption was obtained from medical records.
SETTING


Primary care center in Chantrea (Navarra province, northern Spain). Participants. 351 persons older than 14 years who came to the health center. Outcome measures. Number of units of alcohol consumed per day that participants considered harmful to health, and number of units consumed per day according to information in their medical record.
RESULTS


Perception of problems associated with excess drinking was good, particularly among women. In general, the participants' awareness (including excess drinkers) of the amounts of alcohol that could damage their health was good. Although younger persons tended to identify as harmful to health limits that were above the recommended figures, we found that their consumption was low but was overrecorded. Comparison of the intakes that persons identified as harmful with the amounts of alcohol they actually consumed showed that the latter was generally related with the former, although in 10% of the participants, recorded intake was higher than the limit they identified as harmful. This group contained 80% of the drinkers in our sample who were considered at risk.
CONCLUSIONS


It appears necessary to increase the information given to young persons about harmful levels of alcohol intake; b) we found no clear evidence of risk drinking among younger persons; this will require questioning about their week-end drinking habits; c) risk drinkers know the limits of consumption that can damage their health, but their alcohol consumption is incongruent with this knowledge.",2003,"In general, the participants' awareness (including excess drinkers) of the amounts of alcohol that could damage their health was good.","['351 persons older than 14 years who came to the health center', 'Navarra province, northern Spain', 'Primary care center in Chantrea ']",[],['alcohol consumption'],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",351.0,0.0176583,"In general, the participants' awareness (including excess drinkers) of the amounts of alcohol that could damage their health was good.","[{'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Teruel González', 'Affiliation': 'Centro de Salud de Chantrea. Pamplona. España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martínez Arandigoyen', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baleztena Gurrea', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Fuertes Goñi', 'Affiliation': ''}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'García de la Noceda', 'Affiliation': ''}]",Atencion primaria,[]
996,14636505,[Protocol for the multi-centre evaluation of the Experimental Programme Promotion of Physical Activity (PEPAF)].,"OBJECTIVE


To evaluate the effectiveness of an innovative programme to promote physical activity (PEPAF) introduced into the daily consultations of the family doctor.
DESIGN


Clinical trial with control, randomised for groups of 100 patients seen by one of the 70 doctors taking part, allocated to two parallel groups and monitored for 24 months.Setting. 13 primary care centres coordinated through the Network of Research into Preventive and Health Promotion Activities conducted in primary care.
PARTICIPANTS


Sample with probability of 7000 sedentary patients, selected from among those who consulted for any reason their family doctor during the third quarter of 2003. Patients with cardiovascular disease or other problems meaning that exercise could cause adverse effects will be excluded.
INTERVENTIONS


The doctors allocated to the PEPAF will design a plan of physical activity with those patients prepared to make the change. Those not prepared to will be briefly counselled and given material to help them. All will be monitored at random. The control group doctors will postpone any systematic intervention on exercise until after 2005, excepting those patients whose health problem is directly related to a sedentary life-style.
MEASUREMENTS


The main measurement of results will be the increase in the level of physical activity from the base measurement to those at 3, 6, 12 and 24 months, using 7-day physical activity recall. Health-related quality of life (SF 36) and physical fitness will also be measured. Variables that might be predictive or confusing, such as sex, age, comorbidity, social class, etc., will be considered. Analysis. The average changes observed in the two groups will be compared, on the basis of intention to treat, through analysis of covariance. We will use mixed-effect models able to cover the intra-patient, intra-doctor and intra-centre correlation.",2003,"The control group doctors will postpone any systematic intervention on exercise until after 2005, excepting those patients whose health problem is directly related to a sedentary life-style.
","['Patients with cardiovascular disease', 'Sample with probability of 7000 sedentary patients, selected from among those who consulted for any reason their family doctor during the third quarter of 2003', '100 patients seen by one of the 70 doctors taking part, allocated to two parallel groups and monitored for 24 months', '13 primary care centres coordinated through the Network of Research into Preventive and Health Promotion Activities conducted in primary care']","['Physical Activity (PEPAF', 'PEPAF', 'innovative programme to promote physical activity (PEPAF']","['Health-related quality of life (SF 36) and physical fitness', '7-day physical activity recall', 'level of physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C4708914', 'cui_str': 'Seven thousand'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0035168'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",7000.0,0.0348099,"The control group doctors will postpone any systematic intervention on exercise until after 2005, excepting those patients whose health problem is directly related to a sedentary life-style.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Grandes', 'Affiliation': 'Unidad de Investigacion de Atencion Primaria de Bizkaia. Osakidetza. Servicio Vasco de Salud. Bilbao. Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sánchez', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Torcal', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ortega Sánchez-Pinilla', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lizarraga', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Atencion primaria,[]
997,32097267,Effects of Specific Exercise Therapy on Adolescent Patients with Idiopathic Scoliosis: A Prospective Controlled Cohort Study.,"STUDY DESIGN


A prospective controlled cohort study.
OBJECTIVE


To explore the interventional effect of exercise therapy on idiopathic scoliosis (IS) and identify an optimal intervention window.
SUMMARY OF BACKGROUND DATA


Early conservative treatment is helpful for IS. In addition to bracing, current evidence suggests that exercise can play an important role.
METHODS


We included 99 patients with IS who were treated at the Guangdong Xinmiao Scoliosis Center from August 2013 to September 2017. The inclusion criteria were: 1) new IS diagnosis, 2) Cobb angle 10-25°, 3) Risser 0-3 grade, 4) only treated with the Xinmiao treatment system (XTS; >3 days/week, >1 h/day), and 5) follow-up longer than 1 year. Patients were divided into three age groups: A: <10 years (n = 29); B: 10-12 years (n = 24); and C: 13-15 years (n = 46). The percentages of curve improvement (Cobb angle decrease ≥5°), stability (Cobb angle change × ±5°), and progression (Cobb angle increase ≥5°) were compared.
RESULTS


The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all p < 0.05). The major curve in group A decreased significantly by 6.8° (44% correction), compared to 3.1° (18% correction) and 1.5° (9% correction) in groups B and C, respectively. In group A, 69.0% (20/29) had curve improvement, 27.6% (8/29) stabilized and 3.4% (1/29) progressed. In group B, 45.8% (11/24) improved, 50% (12/24) stabilized, and 4.2% (1/24) progressed. In group C, 26.1% (12/46) improved, 63.0% (29/46) stabilized, and 10.9% (5/46) progressed. There was also a significant difference in final Risser grade among the groups (p < 0.05).
CONCLUSION


For IS patients with Cobb angles between 10° and 25°, our exercise protocol can effectively control or improve curve progression. Younger patients with a lower Risser grade are most likely to respond.
LEVEL OF EVIDENCE


2.",2020,"The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all p < 0.05).","['Adolescent Patients with Idiopathic Scoliosis', '99 patients with IS who were treated at the Guangdong Xinmiao Scoliosis Center from August 2013 to September 2017', 'Younger patients with a lower Risser grade']","['exercise therapy', 'Specific Exercise Therapy']","['final Risser grade', 'major curve correction, Risser sign, first referral, and final follow-up of the main curve', 'percentages of curve improvement (Cobb angle decrease ≥5°), stability (Cobb angle change × ±5°), and progression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",99.0,0.0375908,"The groups showed significant differences for major curve correction, Risser sign, first referral, and final follow-up of the main curve (all p < 0.05).","[{'ForeName': 'Delong', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Spine Surgery, the 1st Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Sizhe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Primary and Secondary School Health Care Center of Zhongshan City, Guangdong, China.'}, {'ForeName': 'Xuexiang', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of sports and Arts, Guangzhou Sport University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jingfan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Spine Center, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Xuan', 'Affiliation': 'Xinmiao Scoliosis Prevention Center of Guangdong Province, Guangzhou, Guangdong, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Spine Center, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zifang', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Spine Surgery, the 1st Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.'}]",Spine,['10.1097/BRS.0000000000003451']
998,13696705,"A clinical trial of ""Mecoral"", an hypnotic tablet containing chloral hydrate.",,1961,,[],['hypnotic tablet containing chloral hydrate'],[],[],"[{'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0008161', 'cui_str': 'Chloral Hydrate'}]",[],,0.0370311,,"[{'ForeName': 'B T', 'Initials': 'BT', 'LastName': 'EMMERSON', 'Affiliation': ''}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'SANDILANDS', 'Affiliation': ''}]",The Medical journal of Australia,[]
999,12888783,Subdissociative dose ketamine produces a deficit in manipulation but not maintenance of the contents of working memory.,"We investigated the effects of subdissociative dose ketamine on executive processes during a working memory task. A total of 11 healthy volunteers participated in a double-blind, placebo-controlled, randomized, within-subjects study. They attended on three occasions, receiving intravenous infusions of placebo, a lower ketamine dose, and a higher ketamine dose. On each occasion, they underwent a series of tasks engaging working memory function in verbal and visuo-spatial domains. Further tasks explored aspects of long-term memory, planning, attention, and perceptual processing. With respect to working memory/executive function, a highly specific pattern of impairment was observed. Impairments were seen only at the higher dose of ketamine and restricted to a subgroup of the verbal working memory tasks: While visuo-spatial working memory showed no evidence of impairment, and while simple maintenance processes during verbal working memory were also unimpaired, higher dose ketamine produced a significant impairment in the manipulation of information within working memory. This process-specific effect of ketamine was reflected in a drug-by-task interaction. The specificity of this ketamine effect suggests that the earliest effect of NMDA receptor blockade is in higher order control of executive function rather than in more basic maintenance processes.",2003,"Impairments were seen only at the higher dose of ketamine and restricted to a subgroup of the verbal working memory tasks: While visuo-spatial working memory showed no evidence of impairment, and while simple maintenance processes during verbal working memory were also unimpaired, higher dose ketamine produced a significant impairment in the manipulation of information within working memory.",['11 healthy volunteers'],"['ketamine', 'subdissociative dose ketamine', 'placebo']",['executive processes'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",11.0,0.140211,"Impairments were seen only at the higher dose of ketamine and restricted to a subgroup of the verbal working memory tasks: While visuo-spatial working memory showed no evidence of impairment, and while simple maintenance processes during verbal working memory were also unimpaired, higher dose ketamine produced a significant impairment in the manipulation of information within working memory.","[{'ForeName': 'Rebekah A E', 'Initials': 'RA', 'LastName': 'Honey', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Turner', 'Affiliation': ''}, {'ForeName': 'Garry D', 'Initials': 'GD', 'LastName': 'Honey', 'Affiliation': ''}, {'ForeName': 'Sam R', 'Initials': 'SR', 'LastName': 'Sharar', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kumaran', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pomarol-Clotet', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'McKenna', 'Affiliation': ''}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': ''}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,[]
1000,32434001,Platelet activation and placenta-mediated adverse pregnancy outcomes: an ancillary study to the Effects of Aspirin in Gestation and Reproduction trial.,"BACKGROUND


Platelet activation may play a role in the pathophysiology of placenta-mediated obstetrical complications, as evidenced by the efficacy of aspirin in preventing preeclampsia, but published data regarding the relationship between biomarkers for platelet activation and adverse obstetrical outcomes are sparse. In particular, it is unknown whether prepregnancy biomarkers of platelet activation are associated with adverse pregnancy outcomes.
OBJECTIVE


This study aimed to determine the following: (1) whether maternal plasma concentrations of platelet factor 4 are associated with risk of placenta-mediated adverse obstetrical outcomes, and (2) whether these associations are modified by low-dose aspirin.
STUDY DESIGN


This ancillary study included measurement of platelet factor 4 among 1185 of 1228 women of reproductive age enrolled in the Effects of Aspirin in Gestation and Reproduction trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation. We measured platelet factor 4 in plasma samples obtained at the prepregnancy study visit (before randomization to low-dose aspirin or placebo), 12 weeks' gestation, and 28 weeks' gestation. The primary outcome was a composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational-age infant. We estimated the relative risks (RRs) and 95% confidence intervals (CIs) for the association between platelet factor 4 and the composite and individual outcomes at each time point using log-binomial regression that was weighted to account for potential selection bias and adjusted for age, body mass index, education, income, and smoking. To evaluate the potential effect modification of aspirin, we stratified the analyses by aspirin treatment assignment.
RESULTS


During follow-up, 95 women experienced the composite adverse obstetrical outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small for gestational age, and 6 of placental abruption. Overall, prepregnancy platelet factor 4 was positively associated with the composite outcome (third tertile vs first tertile; relative risk, 2.36; 95% confidence interval, 1.38-4.03) and with hypertensive disorders of pregnancy (third tertile vs first tertile; relative risk, 2.14; 95% confidence interval, 1.08-4.23). In analyses stratified by treatment group, associations were stronger in the placebo group (third tertile vs first tertile; relative risk, 3.36; 95% confidence interval, 1.42-7.93) than in the aspirin group (third tertile vs first tertile; relative risk, 1.78; 95% confidence interval, 0.90-3.50).
CONCLUSION


High concentrations of platelet factor 4 before pregnancy are associated with increased risk of placenta-mediated adverse pregnancy outcomes, particularly for hypertensive disorders of pregnancy. Aspirin may mitigate the increased risk of these outcomes among women with higher plasma concentrations of preconception platelet factor 4, but low-dose aspirin nonresponders may require higher doses of aspirin or alternate therapies to achieve obstetrical risk reduction.",2020,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[""1,185 of the 1,228 reproductive-age women enrolled in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation"", '95 women experienced the composite adverse obstetric outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small-for-gestational age (SGA), and 6 of placental abruption']","['Aspirin', 'aspirin', 'aspirin or placebo']","['composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational age neonate', 'hypertensive disorders of pregnancy', 'Platelet activation and placenta-mediated adverse pregnancy outcomes']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",584.0,0.178718,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Theilen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT. Electronic address: lauren.theilen@hsc.utah.edu.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Campbell', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.026']
1001,31479196,Comparing the efficacy of Myjet-assisted tranexamic acid and vitamin C in treating melasma: A split-face controlled trial.,"BACKGROUND


Melasma is a benign and chronic hypermelanosis characterized by irregular light brown to dark brown patches of hyperpigmentation on the skin. Oral tranexamic acid (TA) or vitamin C (VC) supplementation has been one treatment choice. TA interferes with keratinocyte-melanocyte interactions, and VC functions by reducing melanin production resulting in skin rejuvenation and whitening.
AIM


The aim of the present study was to compare the efficacy and safety of Myjet assisted transdermal injection of TA vs VC in the treatment of melasma.
METHODS


In this split-face controlled trial, 17 patients were randomized to receive eight weekly transdermal injections of TA or VC via Myjet either on the right or the left side of their face. MASI was measured from each side of the face at the baseline, at the middle, and at the end of treatment.
RESULTS


A reduction in MASI was observed for TA and VC separately (P value < 0.05). The difference in efficacy between TA and VC group was not statistically significant (P value 0.05). Both treatments were well tolerated, with no serious adverse events reported.
CONCLUSION


Weekly TA or VC transdermal injections can be an effective treatment for melasma. Further studies are required to validate these findings.",2020,The difference in efficacy between TA and VC group was not statistically significant (P value 0.05).,"['17 patients', 'melasma']","['transdermal injections of TA or VC via Myjet either on the right or the left side of their face', 'Oral tranexamic acid (TA) or vitamin C (VC) supplementation', 'TA vs VC', 'Myjet-assisted tranexamic acid and vitamin C']","['efficacy', 'MASI', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0374126,The difference in efficacy between TA and VC group was not statistically significant (P value 0.05).,"[{'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Mengna', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Baoxi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13112']
1002,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5']
1003,32434067,"Gastrointestinal Eosinophil Responses in a Longitudinal, Randomized Trial of Peanut Oral Immunotherapy.","BACKGROUND & AIMS


Gastrointestinal side effects are common during oral immunotherapy (OIT) and eosinophilic esophagitis (EoE) is a potential complication. We aimed to characterize eosinophilic gastrointestinal responses to peanut OIT, in which peanut protein is given orally, with incremental increases in dose over time.
METHODS


Twenty adults with IgE-mediated peanut allergy were randomly assigned to groups given peanut OIT (n=15) or placebo (n=5); 1 additional subject withdrew before randomization. Serial gastrointestinal biopsies were collected at baseline (n=21, 0 weeks), following dose escalation (n=10, 52 weeks), and during the maintenance phase (n=11, 104 weeks). Endoscopic findings were characterized using the EoE endoscopic reference score. Biopsies were assessed for eosinophils per high-power field (eos/hpf) and other pathology features using EoE histologic scoring system scores. We performed immunohistochemical analyses of eosinophil peroxidase deposition, quantified using automated image analysis.
RESULTS


At baseline, no subjects reported current gastrointestinal symptoms. However, 3 of the 21 subjects (14%) had esophageal peak eosinophil counts ≥15 eos/hpf and all subjects had dilated intercellular spaces (DIS). OIT induced or exacerbated esophageal eosinophilia (EE) at 52 weeks in most subjects (peak eosinophil counts >5 eos/hpf in 6 of 7 patients [86%]; peak eosinophil counts ≥15 eos/hpf in 4 of 7 patients [57%]). One subject met clinicopathologic criteria for EoE and withdrew; no significant changes in esophageal peak eosinophil counts were observed in the placebo group. EE in the OIT group corresponded with significant increases in EoE histologic scoring system scores and deposition of eosinophil peroxidase. In 4 of 6 participants (67%), OIT-induced EE and gastrointestinal eosinophilia resolved by the end of the maintenance phase. Gastrointestinal symptoms were not clearly associated with EE or gastrointestinal eosinophilia.
CONCLUSIONS


In this pilot study, we found that peanut OIT-induced EE and gastrointestinal eosinophilia are usually transient and are not always associated with gastrointestinal symptoms. Clinicaltrials.gov no: NCT02103270.",2020,EE in the OIT group corresponded with significant increases in EoE histologic scoring system scores and deposition of eosinophil peroxidase.,['Twenty adults with IgE-mediated peanut allergy'],"['placebo', 'peanut OIT', 'Peanut Oral Immunotherapy']","['current gastrointestinal symptoms', 'esophageal peak eosinophil counts', 'EoE histologic scoring system scores and deposition of eosinophil peroxidase', 'OIT-induced EE and gastrointestinal eosinophilia', 'OIT induced or exacerbated esophageal eosinophilia (EE', 'peak eosinophil counts', 'Serial gastrointestinal biopsies', 'Gastrointestinal Eosinophil Responses', 'Gastrointestinal symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}, {'cui': 'C1262481', 'cui_str': 'Eosinophilic gastroenteritis'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",20.0,0.256431,EE in the OIT group corresponded with significant increases in EoE histologic scoring system scores and deposition of eosinophil peroxidase.,"[{'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Wright', 'Affiliation': ""Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ, United States.""}, {'ForeName': 'Nielsen Q', 'Initials': 'NQ', 'LastName': 'Fernandez-Becker', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Neeraja', 'Initials': 'N', 'LastName': 'Kambham', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States; Department of Pathology, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Purington', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tupa', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Wenming', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Sayantani B', 'Initials': 'SB', 'LastName': 'Sindher', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Rank', 'Affiliation': ""Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ, United States.""}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Kita', 'Affiliation': 'Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Department of Immunology, Mayo Clinic Arizona, Scottsdale, AZ, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Kelly P', 'Initials': 'KP', 'LastName': 'Shim', 'Affiliation': ""Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Division of Pulmonology, Phoenix Children's Hospital, Phoenix, AZ, United States.""}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Bunning', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Alfred D', 'Initials': 'AD', 'LastName': 'Doyle', 'Affiliation': 'Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jacobsen', 'Affiliation': 'Division of Allergy, Asthma, and Clinical Immunology, Department of Medicine, Mayo Clinic Arizona, Scottsdale, AZ, United States; Department of Immunology, Mayo Clinic Arizona, Scottsdale, AZ, United States.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States; Department of Pathology, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Boyd', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States; Department of Pathology, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Monali', 'Initials': 'M', 'LastName': 'Manohar', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, CA, United States. Electronic address: schinths@stanford.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.019']
1004,32112136,Effect of probiotics on the intestinal microbiota of hemodialysis patients: a randomized trial.,"BACKGROUND


Intestinal dysbiosis contributes to the progression of renal failure and cardiovascular diseases in patients with chronic kidney disease. Probiotics is a promising intervention to improving intestinal dysbiosis. A double-blind clinical trial to investigate the ability of probiotics to modulate gut microbiota compositions in patients receiving hemodialysis (HD) was undertaken.
METHODS


Fifty HD patients were enrolled and randomized, receiving either probiotics or placebo for 6 months. The responses to the interventions on gut microbiome, serum and fecal metabolome, serum albumin and endotoxin, endothelial activation markers and inflammatory markers were assessed.
RESULTS


Totally, 22 in the probiotics group (11 males; 14 non-diabetic) and 23 in the placebo group (13 males; 17 non-diabetic) completed the study. Compared to that in the placebo group, probiotics did not significantly alter species diversity of the fecal microbiome. Probiotics did, however, restore the community composition, with particular significance in non-diabetic HD patients (P = 0.007 by Adonis analysis). Specifically, according to the results of linear discriminate analysis effect size, probiotics raised the proportions of family Bacteroidaceae and Enterococcaceae, and reduced Ruminococcaceae, Halomonadaceae, Peptostreptococcaceae, Clostridiales Family XIII. Incertae Sedis and Erysipelotrichaceae in non-diabetic HD patients. Additionally, probiotics reduced the abundances of several uremic retention solutes in serum or feces, including indole-3-acetic acid-O-glucuronide, 3-guanidinopropionic acid, and 1-methylinosine (P < 0.05). In the probiotic arm, no significant changes were observed in other secondary outcomes.
CONCLUSIONS


Taken together, outcomes from this study suggest that probiotics do have benefits on improving intestinal imbalances and lowering exposure to several uremic toxins in HD patients.",2020,"Additionally, probiotics reduced the abundances of several uremic retention solutes in serum or feces, including indole-3-acetic acid-O-glucuronide, 3-guanidinopropionic acid, and 1-methylinosine (P < 0.05).","['Totally, 22 in the probiotics group (11 males; 14 non-diabetic) and 23 in the placebo group (13 males; 17 non-diabetic) completed the study', 'non-diabetic HD patients', 'patients receiving hemodialysis (HD', 'Fifty HD patients', 'hemodialysis patients', 'HD patients', 'patients with chronic kidney disease']","['probiotics', 'Probiotics', 'probiotics or placebo', 'placebo']","['gut microbiome, serum and fecal metabolome, serum albumin and endotoxin, endothelial activation markers and inflammatory markers', 'species diversity of the fecal microbiome', 'abundances of several uremic retention solutes in serum or feces, including indole-3-acetic acid-O-glucuronide, 3-guanidinopropionic acid, and 1-methylinosine', 'proportions of family Bacteroidaceae and Enterococcaceae, and reduced Ruminococcaceae, Halomonadaceae, Peptostreptococcaceae, Clostridiales Family XIII']","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0936060', 'cui_str': '1H-Indole-3-acetic acid'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0061956', 'cui_str': 'beta-guanidine propionic acid'}, {'cui': 'C0044474', 'cui_str': '1-methylinosine'}, {'cui': 'C0004660', 'cui_str': 'Bacteroidaceae'}, {'cui': 'C1035041', 'cui_str': 'Enterococcaceae'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C1001948', 'cui_str': 'Halomonadaceae'}, {'cui': 'C1210565', 'cui_str': 'Family Peptostreptococcaceae'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",50.0,0.0601821,"Additionally, probiotics reduced the abundances of several uremic retention solutes in serum or feces, including indole-3-acetic acid-O-glucuronide, 3-guanidinopropionic acid, and 1-methylinosine (P < 0.05).","[{'ForeName': 'Sixiu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Liang', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Kehui', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Meng', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Dialysis Department of Nephrology Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, West Yanta Road 277, Xi'an, 710061, Shaanxi, China. j92106@sina.com.""}]",European journal of nutrition,['10.1007/s00394-020-02207-2']
1005,31764959,Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials.,"Importance


Alzheimer disease (AD) is a neurodegenerative disorder characterized by cognitive deterioration and impaired activities of daily living. Current treatments provide only minor symptomatic improvements with limited benefit duration. Lanabecestat, a brain-permeable inhibitor of human beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1/β-secretase), was developed to modify the clinical course of AD by slowing disease progression.
Objective


To assess whether lanabecestat slows the progression of AD compared with placebo in patients with early AD (mild cognitive impairment) and mild AD dementia.
Design, Setting, and Participants


AMARANTH (first patient visit on September 30, 2014; last patient visit on October 4, 2018) and DAYBREAK-ALZ (first patient visit on July 1, 2016; last patient visit on September 28, 2018) were randomized, placebo-controlled, phase 2/3 and phase 3 clinical trials lasting 104 weeks and 78 weeks, respectively. AMARANTH and DAYBREAK-ALZ were multicenter, global, double-blind studies conducted at 257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively. A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging-Alzheimer's Association criteria for early AD or mild AD dementia was screened using cognitive assessments, and the presence of amyloid was confirmed. Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation. AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study. DAYBREAK-ALZ screened 5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study.
Interventions


Patients were randomized (1:1:1) to once-daily oral doses of lanabecestat (20 mg), lanabecestat (50 mg), or placebo.
Main Outcomes and Measures


The primary outcome measure was change from baseline on the 13-item Alzheimer Disease Assessment Scale-cognitive subscale. Secondary outcomes included Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory. Efficacy analyses were conducted on the intent-to-treat population.
Results


Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women. Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women. Both studies were terminated early after futility analysis. There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
Conclusions and Relevance


Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline.
Trial Registration


ClinicalTrials.gov identifiers: NCT02245737 and NCT02783573.",2020,"Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
","['Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women', 'AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study', 'Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women', '5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study', '257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively', 'Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation', 'patients with early AD (mild cognitive impairment) and mild AD dementia', 'Early and Mild Alzheimer Disease', ""A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging-Alzheimer's Association criteria for early AD or mild AD dementia""]","['placebo', 'lanabecestat (20 mg), lanabecestat (50 mg), or placebo', 'Lanabecestat', 'lanabecestat']","['13-item Alzheimer Disease Assessment Scale-cognitive subscale', 'Efficacy and Safety', ""Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory"", 'Psychiatric adverse events, weight loss, and hair color changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0333612', 'cui_str': 'Postinflammatory hypopigmentation (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1955974', 'cui_str': 'National Institute on Aging'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0474378', 'cui_str': 'Hair color change (finding)'}]",539.0,0.552879,"Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
","[{'ForeName': 'Alette M', 'Initials': 'AM', 'LastName': 'Wessels', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, University of Arizona College of Medicine, Phoenix.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Zimmer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Selzler', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sonja M', 'Initials': 'SM', 'LastName': 'Bragg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Andersen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Krull', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'AnnCatherine M', 'Initials': 'AM', 'LastName': 'Downing', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Willis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shcherbinin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Mullen', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schumi', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Shering', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Brandy R', 'Initials': 'BR', 'LastName': 'Matthews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Stern', 'Affiliation': ""Alzheimer's Disease Center, Boston University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Unités Mixtes de Recherche Institut National de la Santé et de la Recherche Médicale 1027, Université Toulouse III-Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Toronto Memory Program, Toronto, Ontario, Canada.'}, {'ForeName': 'Emer', 'Initials': 'E', 'LastName': 'MacSweeney', 'Affiliation': 'Re:Cognition Health, London, United Kingdom.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': 'Research Center and Memory Clinic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociències Aplicades, Barcelona-Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Sims', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3988']
1006,31388914,Family Caregiver Skills Training to Improve Experiences of Care: a Randomized Clinical Trial.,"OBJECTIVE


To evaluate the effectiveness of Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES), a skills training program for caregivers of persons with functional or cognitive impairments.
DESIGN


A two-arm RCT.
SETTING


Single Veterans Affairs Medical Center.
PARTICIPANTS


Patients and their primary caregivers referred in the past 6 months to home and community-based services or geriatrics clinic.
INTERVENTION


All caregivers received usual care. Caregivers in HI-FIVES also received five training calls and four group training sessions.
MAIN MEASURES


Cumulative patient days at home 12 months post-randomization, defined as days not in an emergency department, inpatient hospital, or post-acute facility. Secondary outcomes included patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms.
RESULTS


Of 241 dyads, caregivers' (patients') mean age was 61 (73) years, 54% (53%) Black and 89% (4%) female. HI-FIVES was associated with a not statistically significant 9% increase in the rate of days at home (95% CI 0.72, 1.65; mean difference 1 day over 12 months). No significant differences were observed in health care costs or caregiver depressive symptoms. Model-estimated mean baseline patient experience of VA care (scale of 0-10) was 8.43 (95% CI 8.16, 8.70); the modeled mean difference between HI-FIVES and controls at 3 months was 0.29 (p = .27), 0.31 (p = 0.26) at 6 months, and 0.48 (p = 0.03) at 12 months. For caregivers, it was 8.34 (95% CI 8.10, 8.57); the modeled mean difference at 3 months was 0.28 (p = .18), 0.53 (p < .01) at 6 months, and 0.46 (p = 0.054) at 12 months.
CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points. The training holds promise in increasing an important metric of care quality-reported experience with care.",2019,"CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points.","['Patients and their primary caregivers referred in the past 6\xa0months to home and community-based services or geriatrics clinic', 'caregivers of persons with functional or cognitive impairments', 'Single Veterans Affairs Medical Center', 'mean age was 61 (73) years, 54% (53', ""Of 241 dyads, caregivers' (patients""]","['Family Caregiver Skills Training', 'usual care', 'skills training program']","['emergency department, inpatient hospital, or post-acute facility', 'HI', 'rate of days at home', ""patients' total VA health care costs, caregiver and patient rating of the patient's experience of VA health care, and caregiver depressive symptoms"", 'health care costs or caregiver depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",241.0,0.133213,"CONCLUSIONS


HI-FIVES did not increase patients' days at home; it showed sustained improvements in caregivers' and patients' experience of VA care at clinically significant levels, nearly 0.5 points.","[{'ForeName': 'Courtney Harold', 'Initials': 'CH', 'LastName': 'Van Houtven', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA. courtney.vanhoutven@duke.edu.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Lindquist', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Chapman', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hendrix', 'Affiliation': 'School of Nursing, Duke University Medical Center, 307 Trent Drive, Box 102400, Durham, NC, 27710, USA.'}, {'ForeName': 'Susan Nicole', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'King', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Shepherd-Banigan', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, HSRD 152, 508 Fulton Street, Durham, NC, 27705, USA.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Weinberger', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 1101A McGavran-Greenberg Hall, Campus Box 7411, Chapel Hill, NC, 27599, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05209-x']
1007,32438990,Prognostic Value of SYNTAX Score in Patients With Infarct-Related Cardiogenic Shock: Insights From the CULPRIT-SHOCK Trial.,"OBJECTIVES


This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS).
BACKGROUND


The prognostic value of the SYNTAX score in this high-risk setting remains unclear.
METHODS


The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (22<SS≤32) and high SYNTAX score (SS>32). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression.
RESULTS


Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p < 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes.
CONCLUSIONS


In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality.",2020,"After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death.","['patients presenting with infarct-related CS and multivessel disease', 'Patients', 'patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS']",['SYNTAX'],"['30-day risk of death or renal replacement therapy (RRT) and 1-year death', '30-day death or RRT and 1-year mortality', 'Baseline SYNTAX score', '30-day risk of death or RRT and the 1-year risk of death', 'low SYNTAX score (SS\xa0≤22), intermediate SYNTAX score (22<SS≤32) and high SYNTAX score (SS>32', '30-day risk of death or renal replacement therapy and 1-year risk of all-cause death', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.1222,"After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Hage', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Kerneis', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Overtchouk', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'ACTION Study Group, Statistician Unit, StatEthic, Levallois-Perret, France.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen, Institut fur Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.04.003']
1008,31809265,Adherence to multiple medications in the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) cohort: effect of additional medications on adherence to primary diabetes medication.,"Background Non-adherence to diabetes medication leads to poor outcomes and increased healthcare costs. Multiple factors affecting adherence in adults with type 2 diabetes (T2D) have been identified, but pediatric data is sparse. We aimed to determine whether initiation of additional oral medications or insulin affects adherence to primary study medication (PSM) in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset T2D were randomized in the TODAY study. Participants were categorized as adherent (≥80% taken by pill count) or non-adherent (<80%), and adherence was compared between those on additional medications or not. Subgroup analyses to assess influence of race/ethnicity, gender, medication type, or depression were performed. Results At 36 months, 46.3% of participants were taking additional oral medications and 31.9% were on insulin. There was no difference in study medication adherence with additional oral medications (55.1%, 67.1%, and 56.7% at month 36 in those prescribed 0, 1, or 2+  additional medications; p = 0.16). Girls on oral contraceptives (OC) had higher adherence (65.2% vs. 55.8% at month 36; p = 0.0054). Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001). There was decreased adherence in participants with baseline depression (p = 0.008). Conclusions Additional oral medications did not influence adherence to diabetes medications in TODAY. Addition of insulin led to reduced adherence. In subgroup analyses, OC use was associated with higher adherence in girls, while baseline depression was associated with lower adherence overall. Further studies examining potentially modifiable risk factors of adherence in pediatric T2D are needed.",2020,Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001).,"['adults with type 2 diabetes (T2D', 'Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset', 'type 2 Diabetes in Adolescents and Youth (TODAY) study']","['oral contraceptives (OC', 'insulin']","['healthcare costs', 'study medication adherence with additional oral medications', 'adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",699.0,0.0953591,Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001).,"[{'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Siripoom V', 'Initials': 'SV', 'LastName': 'McKay', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'The George Washington University Biostatistics Center, 6110 Executive Boulevard, Suite 750, Rockville, MD 20852, USA, Office: +301-881-9260, Fax: +301-881-3767.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Casey', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Higgins', 'Affiliation': 'Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, Boston, MA, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Izquierdo', 'Affiliation': 'State University of New York Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Aimee D', 'Initials': 'AD', 'LastName': 'Wauters', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chang', 'Affiliation': ""Diabetes and Obesity Program, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric endocrinology & metabolism : JPEM,['10.1515/jpem-2019-0315']
1009,32000790,Effects of robot therapy on upper body kinematics and arm function in persons post stroke: a pilot randomized controlled trial.,"BACKGROUND


Robot-based rehabilitation for persons post-stroke may improve arm function and daily-life activities as measured by clinical scales, but its effects on motor strategies during functional tasks are still poorly investigated. This study aimed at assessing the effects of robot-therapy versus arm-specific physiotherapy in persons post-stroke on motor strategies derived from upper body instrumented kinematic analysis, and on arm function measured by clinical scales.
METHODS


Forty persons in the sub-acute and chronic stage post-stroke were recruited. This sample included all those subjects, enrolled in a larger bi-center study, who underwent instrumented kinematic analysis and who were randomized in Center 2 into Robot (R_Group) and Control Group (C_Group). R_Group received robot-assisted training. C_Group received arm-specific treatment delivered by a physiotherapist. Pre- and post-training assessment included clinical scales and instrumented kinematic analysis of arm and trunk during a virtual untrained task simulating the transport of an object onto a shelf. Instrumented outcomes included shoulder/elbow coordination, elbow extension and trunk sagittal compensation. Clinical outcomes included Fugl-Meyer Motor Assessment of Upper Extremity (FM-UE), modified Ashworth Scale (MAS) and Functional Independence Measure (FIM).
RESULTS


R_Group showed larger post-training improvements of shoulder/elbow coordination (Cohen's d = - 0.81, p = 0.019), elbow extension (Cohen's d = - 0.71, p = 0.038), and trunk movement (Cohen's d = - 1.12, p = 0.002). Both groups showed comparable improvements in clinical scales, except proximal muscles MAS that decreased more in R_Group (Cohen's d = - 0.83, p = 0.018). Ancillary analyses on chronic subjects confirmed these results and revealed larger improvements after robot-therapy in the proximal portion of FM-UE (Cohen's d = 1.16, p = 0.019).
CONCLUSIONS


Robot-assisted rehabilitation was as effective as arm-specific physiotherapy in reducing arm impairment (FM-UE) in persons post-stroke, but it was more effective in improving motor control strategies adopted during an untrained task involving vertical movements not practiced during training. Specifically, robot therapy induced larger improvements of shoulder/elbow coordination and greater reduction of abnormal trunk sagittal movements. The beneficial effects of robot therapy seemed more pronounced in chronic subjects. Future studies on a larger sample should be performed to corroborate present findings.
TRIAL REGISTRATION


www.ClinicalTrials.gov NCT03530358. Registered 21 May 2018. Retrospectively registered.",2020,"CONCLUSIONS


Robot-assisted rehabilitation was as effective as arm-specific physiotherapy in reducing arm impairment (FM-UE) in persons post-stroke, but it was more effective in improving motor control strategies adopted during an untrained task involving vertical movements not practiced during training.","['chronic subjects', 'Forty persons in the sub-acute and chronic stage post-stroke were recruited', 'persons post stroke', 'This sample included all those subjects, enrolled in a larger bi-center study, who underwent instrumented kinematic analysis and who were randomized in Center 2 into', 'persons post-stroke']","['Robot (R_Group) and Control Group (C_Group', 'Robot-assisted rehabilitation', 'Pre- and post-training assessment included clinical scales and instrumented kinematic analysis of arm and trunk during a virtual untrained task simulating the transport of an object onto a shelf', 'robot-therapy versus arm-specific physiotherapy', 'robot-assisted training', 'robot therapy']","['abnormal trunk sagittal movements', 'shoulder/elbow coordination', 'elbow extension', 'larger post-training improvements of shoulder/elbow coordination', 'Fugl-Meyer Motor Assessment of Upper Extremity (FM-UE), modified Ashworth Scale (MAS) and Functional Independence Measure (FIM', 'upper body kinematics and arm function', 'trunk movement', 'clinical scales, except proximal muscles MAS', 'shoulder/elbow coordination, elbow extension and trunk sagittal compensation']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}]",,0.0963772,"CONCLUSIONS


Robot-assisted rehabilitation was as effective as arm-specific physiotherapy in reducing arm impairment (FM-UE) in persons post-stroke, but it was more effective in improving motor control strategies adopted during an untrained task involving vertical movements not practiced during training.","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Carpinella', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Lencioni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy. tlencioni@dongnocchi.it.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bowman', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Bertoni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Turolla', 'Affiliation': 'Movement Neuroscience Research Group, IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venezia, Lido, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrarin', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Jonsdottir', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-0646-1']
1010,31568094,"Improved Accuracy of Cervical Spinal Surgery With Robot-Assisted Screw Insertion: A Prospective, Randomized, Controlled Study.","STUDY DESIGN


Prospective, randomized, controlled trial.
OBJECTIVE


To compare robot-assisted and conventional implantation techniques by evaluating the accuracy and safety of implanting screws in cervical vertebrae.
SUMMARY OF BACKGROUND DATA


Cervical spinal surgery is difficult and dangerous as screw misplacement might lead not only to decreased stability but also neurological, vascular, and visceral injuries. A new robot-assisted surgical procedure has been introduced to improve the accuracy of implant screw positioning.
METHODS


We randomly assigned 135 patients with newly diagnosed cervical spinal disease and who required screw fixation using either robot-assisted or conventional fluoroscopy-assisted cervical spinal surgery. The primary outcomes were the discrepancies between the planned trajectories and the actual screw positions.
RESULTS


Altogether, 127 patients underwent the assigned intervention (61 robot-assisted and 66 conventional fluoroscopy-assisted). The baseline characteristics including the screw types, were similar in the two groups. Altogether, 390 screws were planed and placed in the cervical vertebrae, and 94.9% were acceptable. The robot-assisted group had a better screw placement accuracy than the conventional fluoroscopy-assisted group with associated P values <0.001 (0.83 [0.44, 1.29] vs. 1.79 [1.41, 2.50] mm). The Gertzbein and Robbins scales also showed a significant difference between the two groups (P < 0.001). Furthermore, the robot-assisted group experienced significantly less blood loss during surgery than the conventional fluoroscopy-assisted group (200 [50, 375] vs. 350 [100, 500] mL; P = 0.002) and shorter length of stay after surgery (P = 0.021). These two groups did not differ significantly regarding the duration of the operation (P = 0.525). Neurological injury occurred in one case in the conventional fluoroscopy-assisted group.
CONCLUSION


The accuracy and clinical outcomes of cervical spinal surgery using the robot-assisted technique tended to be superior to those with the conventional fluoroscopy-assisted technique in this prospective, randomized, controlled trial.
LEVEL OF EVIDENCE


2.",2020,"The robot-assisted group had a better screw placement accuracy than the conventional fluoroscopy-assisted group with associated p values <0.001 [0.83 (0.44, 1.29) vs 1.79 (1.41, 2.50) mm].","['135 patients with newly diagnosed cervical spinal disease and who required', '127 patients underwent the assigned intervention (61 robot-assisted and 66 conventional fluoroscopy-assisted']","['conventional fluoroscopy-assisted technique', 'cervical spinal surgery using the robot-assisted technique', 'screw fixation using either robot-assisted or conventional fluoroscopy-assisted cervical spinal surgery', 'robot-assisted and conventional implantation techniques', 'Cervical Spinal Surgery With Robot-Assisted Screw Insertion']","['Gertzbein and Robbins scales', 'shorter length of stay', 'screw placement accuracy', 'discrepancies between the planned trajectories and the actual screw positions', 'Neurological injury', 'blood loss', 'duration of the operation']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0037933', 'cui_str': 'Spinal Diseases'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]",135.0,0.151244,"The robot-assisted group had a better screw placement accuracy than the conventional fluoroscopy-assisted group with associated p values <0.001 [0.83 (0.44, 1.29) vs 1.79 (1.41, 2.50) mm].","[{'ForeName': 'Mingxing', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'He', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Duan', 'Affiliation': 'Epidemiological Research Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Spine Department, Beijing Jishuitan Hospital, Beijing, China.'}]",Spine,['10.1097/BRS.0000000000003258']
1011,31464757,Preliminary Study of the Effect of Training With a Gaming Balance Board on Balance Control in Children With Cerebral Palsy: A Randomized Controlled Trial.,"OBJECTIVE


A new protocol based on the use of a gaming balance board for children with cerebral palsy was tested.
DESIGN


A total of 56 children with cerebral palsy were enrolled and randomly divided into two groups: experimental and control. The children in experimental group underwent 12 wks of rehabilitation using their foot to play personal computer games with the proposed balance board, whereas those in the control group played personal computer games with a computer mouse in the standing position. Balance control was assessed before and after the intervention using the Zebris FDM System for measuring the center of pressure. The Pediatric Balance Scale and 2-min walk test were used for evaluating functional balance.
RESULTS


In the analysis of covariance, the proposed new balance board used for the personal computer games decreased the postural sway (sway path, F = 6.95, P = 0.011; sway area, F = 11.79, P = 0.001) and improved the performance of the functional balance tests.
CONCLUSIONS


This study demonstrated the possibility that this new gaming balance board can be used for balance control in children with cerebral palsy.",2020,Balance control was assessed before and after the intervention using the Zebris FDM System for measuring the center of pressure.,"['56 children with cerebral palsy', 'children with cerebral palsy']","['rehabilitation using their foot to play personal computer games with the proposed balance board, whereas those in the control group played personal computer games with a computer mouse in the standing position', 'training with a gaming balance board']","['postural sway', 'Balance control', 'performance of the functional balance tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0162419', 'cui_str': 'Personal Computers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721267', 'cui_str': 'Balance board'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position (finding)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",56.0,0.0171743,Balance control was assessed before and after the intervention using the Zebris FDM System for measuring the center of pressure.,"[{'ForeName': 'Hsieh-Chun', 'Initials': 'HC', 'LastName': 'Hsieh', 'Affiliation': 'From the Department of Special Education, National Tsing Hua University, Hsinchu City, Taiwan, Republic of China.'}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001300']
1012,31467115,Efficacy and safety of inhaled α1-antitrypsin in patients with severe α1-antitrypsin deficiency and frequent exacerbations of COPD.,"Patients with inherited α1-antitrypsin (AAT) deficiency (ZZ-AATD) and severe chronic obstructive pulmonary disease (COPD) frequently experience exacerbations. We postulated that inhalation of nebulised AAT would be an effective treatment.We randomly assigned 168 patients to receive twice-daily inhalations of 80 mg AAT solution or placebo for 50 weeks. Patients used an electronic diary to capture exacerbations. The primary endpoint was time from randomisation to the first event-based exacerbation. Secondary endpoints included change in the nature of the exacerbation as defined by the Anthonisen criteria. Safety was also assessed.Time to first moderate or severe exacerbation was a median of 112 days (interquartile range (IQR) 40-211 days) for AAT and 140 days (IQR 72-142 days) for placebo (p=0.0952). The mean yearly rate of all exacerbations was 3.12 in the AAT-treated group and 2.67 in the placebo group (p=0.31). More patients receiving AAT reported treatment-related treatment-emergent adverse events compared to placebo (57.5%  versus  46.9%, respectively) and they were more likely to withdraw from the study. After the first year of the study, when modifications to the handling of the nebuliser were introduced, the rate of safety events in the AAT-treated group dropped to that of the placebo group.We conclude that in AATD patients with severe COPD and frequent exacerbations, AAT inhalation for 50 weeks showed no effect on time to first exacerbation but may have changed the pattern of the episodes.",2019,"More patients receiving AAT reported treatment-related TEAEs (Treatment Emergent Adverse Events) compared to placebo (57·5%  versus  46·9%, respectively) and they were more likely to withdraw from the study.","['Patients with inherited alpha-1-antitrypsin (AAT) deficiency (ZZ-AATD) and severe chronic obstructive pulmonary disease (COPD) frequently suffer from exacerbations', 'patients with severe alpha-1-antitrypsin deficiency and frequent exacerbations of Chronic Obstructive Pulmonary Disease']","['placebo', 'nebulised AAT', 'inhaled alpha-1-antitrypsin', 'AAT solution or placebo']","['time from randomisation to the first event-based exacerbation', 'Efficacy and safety', 'mean yearly rate of all exacerbations', 'Time to first moderate or severe exacerbation', 'Safety', 'rate of safety events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221757', 'cui_str': 'alpha 1-Antitrypsin Deficiency'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0002191', 'cui_str': 'alfa1 antitrypsin'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",168.0,0.349897,"More patients receiving AAT reported treatment-related TEAEs (Treatment Emergent Adverse Events) compared to placebo (57·5%  versus  46·9%, respectively) and they were more likely to withdraw from the study.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stolk', 'Affiliation': 'Dept of Pulmonology, Member of European Reference Network LUNG, Leiden University Medical Centre, Leiden, NL j.stolk@lumc.nl.'}, {'ForeName': 'Naveh', 'Initials': 'N', 'LastName': 'Tov', 'Affiliation': 'Dept of Clinical Development, Kamada Ltd, Rehovot, Israel.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Chapman', 'Affiliation': 'Dept of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Fernandez', 'Affiliation': 'Independent Consultant, Penn, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'MacNee', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Piitulainen', 'Affiliation': 'Dept of Respiratory Medicine and Allergology, Malmö, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Seersholm', 'Affiliation': 'Dept of Respiratory Medicine Y, Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Dept of Medicine, Pulmonary and Critical Care Medicine, Member of the German Center for Lung Diseases (DZL), University Medical Centre Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bals', 'Affiliation': 'Internal Medicine V - Pulmonology, Member of the German Center for Lung Diseases (DZL), Hospital of the University of the Saarland, Homburg, Germany.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'McElvaney', 'Affiliation': 'Dept of Respiratory Medicine, Beaumont Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Stockley', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}]",The European respiratory journal,['10.1183/13993003.00673-2019']
1013,31471180,Hemostatic and Anti-Inflammatory Effects of Carbazochrome Sodium Sulfonate in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


Postoperative recovery after total knee arthroplasty (TKA) is associated with postoperative anemia, allogeneic transfusion, and stress immune responses to surgery. Carbazochrome sodium sulfonate (CSS) reduces bleeding through several mechanisms. We assessed the effect of CSS combined with tranexamic acid (TXA) on postoperative anemia, blood transfusion, and inflammatory responses.
METHODS


This study was designed as a randomized, placebo-controlled trial of 200 patients undergoing unilateral primary TKA. Patients were divided into 4 groups: group A received TXA plus topical and intravenous CSS; group B received TXA plus topical CSS only; group C received TXA plus intravenous CSS only; group D received TXA only.
RESULTS


Total blood loss in groups A (609.92 ± 221.24 mL), B (753.16 ± 247.67 mL), and C (829.23 ± 297.45 mL) was lower than in group D (1158.26 ± 334.13 mL, P < .05). There was no difference in total blood loss between groups B and C. We also found that compared with group D, the postoperative swelling rate, biomarker level of inflammation, visual analog scale pain score, and range of motion at discharge in groups A, B, and C were significantly improved (P < .05). No thromboembolic complications occurred. There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05).
CONCLUSION


CSS combined with TXA was more effective than TXA alone in reducing perioperative blood loss and inflammatory response and did not increase the incidence of thromboembolism complications.",2020,"There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05).
","['200 patients undergoing unilateral primary TKA', 'Patients Undergoing Total Knee Arthroplasty']","['CSS combined with tranexamic acid (TXA', 'Carbazochrome sodium sulfonate (CSS', 'placebo', 'TXA plus topical and intravenous CSS', 'total knee arthroplasty (TKA', 'Carbazochrome Sodium Sulfonate', 'TXA plus topical CSS', 'TXA only', 'TXA', 'TXA plus intravenous CSS']","['postoperative swelling rate, biomarker level of inflammation, visual analog scale pain score, and range of motion at discharge', 'postoperative anemia, blood transfusion, and inflammatory responses', 'thromboembolic complications', 'total blood loss', 'perioperative blood loss and inflammatory response', 'incidence of thromboembolism complications', 'Total blood loss', 'transfusion rate, intraoperative blood loss, platelet count, or average length of stay']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0054657', 'cui_str': 'carbazochrome sodium sulfonate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",200.0,0.155413,"There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05).
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Yeersheng', 'Initials': 'Y', 'LastName': 'Releken', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Zhouyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'FuXing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2019.07.045']
1014,31464753,Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial.,"OBJECTIVE


The aim of the study was to investigate the effects of the inclusion of neural mobilization into a motor control exercise program on pain, related disability, neuropathic symptoms, straight leg raise, and pressure pain threshold in lumbar radiculopathy.
DESIGN


This is a randomized clinical trial.
METHODS


Individuals with low back pain, with confirmed disc herniation, and lumbar radiculopathy were randomly assigned to receive eight sessions of either neurodynamic mobilization plus motor control exercises (n = 16) or motor control exercises alone (n = 16). Outcomes included pain, disability, neuropathic symptoms, straight leg raise, and pressure pain threshold at baseline, after four visits, after eight visits, and after 2 mos.
RESULTS


There were no between-groups differences for pain, related disability, or pressure pain threshold at any follow-up period because both groups get similar and large improvements. Patients assigned to the neurodynamic program group experienced better improvements in neuropathic symptoms and the straight leg raise compared with the motor control exercise group (P < 0.01).
CONCLUSIONS


The addition of neurodynamic mobilization to a motor control exercise program leads to reductions in neuropathic symptoms and mechanical sensitivity (straight leg raise) but did not result in greater changes of pain, related disability, or pressure pain threshold over motor control exercises program alone in subjects with lumbar radiculopathy. Future trials are needed to further confirm these findings because between-groups differences did not reach clinically relevance.",2020,"Patients assigned to the neurodynamic program group experienced better improvements in neuropathic symptoms and the SLR compared to the motor control exercise group (P<0.01).
","['Individuals with LBP, with confirmed disc herniation, and lumbar radiculopathy', 'Patients with Lumbar Radiculopathy due to Disc Herniation', 'subjects with lumbar radiculopathy']","['neurodynamic mobilization plus motor control exercises (n=16) or motor control exercises alone', 'motor control exercise program', 'Neurodynamic Mobilization to Motor Control Training', 'neurodynamic program', 'neural mobilization into a motor control exercise program']","['neuropathic symptoms', 'pain, disability, neuropathic symptoms, SLR, and PPT at baseline, after 4 visits, after 8 visits, and after 2-months', 'pain, related-disability, neuropathic symptoms, straight leg raise (SLR), and pressure pain threshold (PPT', 'neuropathic symptoms and mechanical sensitivity (SLR', 'pain, related-disability, or PPT']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.0926261,"Patients assigned to the neurodynamic program group experienced better improvements in neuropathic symptoms and the SLR compared to the motor control exercise group (P<0.01).
","[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'From the Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain (GP-M); Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain (GP-M); Clínica Fisiofit, Madrid, Spain (IC-C); Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain (CF-d-l-P, JLA-B, RO-S); Cátedra de Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio Terapeútico, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain (CF-d-l-P, JLA-B, RO-S); Physical Therapist, Rehabilitation Services, Concord Hospital, Concord, New Hampshire (JAC); Faculty, Manual Therapy Fellowship Program, Regis University, Denver, Colorado (JAC); Department of Physical Therapy, Franklin Pierce University, Manchester, New Hampshire (JAC); and Fysio-Experts, Hazerswoude-Rijndijk, the Netherlands (MT-d-G).'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cancela-Cilleruelo', 'Affiliation': ''}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': ''}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Thoomes-de-Graaf', 'Affiliation': ''}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001295']
1015,31466693,"Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools.","BACKGROUND


The PRIDE programme aims to establish a suite of transdiagnostic psychological interventions organised around a stepped care system in Indian secondary schools. This paper describes the development of a low-intensity, first-line component of the PRIDE model.
METHOD


Contextual and global evidence informed an intervention 'blueprint' with problem solving as the primary practice element. Successive iterations were tested and modified across two pilot cohort studies (N = 45; N = 39). Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools.
RESULTS


The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists. However, delivery was not feasible within the intended 6-week schedule, and participants struggled to use materials outside 'guidance' sessions. In Pilot 2, a modified counsellor-led problem-solving intervention was implemented by less experienced counsellors over a 3-4 week schedule. Outcomes were maintained, with indications of enhanced feasibility and acceptability. High demand was observed across both pilots, leading to more stringent eligibility criteria and a modified sensitisation plan.
DISCUSSION


Findings have shaped a first-line intervention for common adolescent mental health problems in low-resource settings. A forthcoming randomised controlled trial will test its effectiveness.",2020,"The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists.","['Indian secondary schools', 'common adolescent mental health problems in Indian secondary schools', 'Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools']","['modified counsellor-led problem-solving intervention', 'transdiagnostic, low-intensity, psychological intervention']",[],"[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",[],,0.0559856,"The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Malik', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Krishna', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Sangath, Goa and New Delhi, India; Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Kallol', 'Initials': 'K', 'LastName': 'Roy', 'Affiliation': 'Shree Krishna Hospital, Gujarat, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rooplata', 'Initials': 'R', 'LastName': 'Sahu', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Bhagwant', 'Initials': 'B', 'LastName': 'Chilhate', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Department of Psychology, Loma Linda University, Los Angeles, USA.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, Goa and New Delhi, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA; Harvard TH Chan School of Public Health, Boston, USA. Electronic address: Vikram_Patel@hms.harvard.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103439']
1016,32440938,Comparison of two vasoconstrictors on glycemic levels in diabetic patients.,"OBJECTIVES


The aim of this study was to evaluate glycemic levels in diabetic patients before, during, and after extractions using 2% lidocaine with 1:100,000 epinephrine (Lido/Epi) and 3% prilocaine with 0.03 IU/mL felypressin (Prilo/Fely).
MATERIALS AND METHODS


A double-blind, randomized clinical trial was conducted to evaluate changes in body parameters and glycemic levels in diabetic patients undergoing two anesthetic protocols during dental extractions. During surgery, we evaluated blood pressure (BP), heart rate (HR), saturation (SpO2), and capillary glycemic levels (Gly). These parameters were measured at the following surgical moments: basal, 30 min after medication, incision, tooth removal, suture, and 30 and 60 min after anesthesia.
RESULTS


Data analysis showed no differences between the groups considering age, weight, and time spent in surgery. Increased systolic BP and decreased diastolic BP were observed in the lido/epi group. No difference was observed in the prilo/fely group among the surgical moments or between the groups regarding BP. No difference was observed in HR and SpO2 between the groups at any surgical moment. However, differences were found when compared the differences in glycemic and basal levels in both groups with greater decreases in blood glucose values for the lido/epi group. In anxiety level evaluation, there was no difference between the different surgical moments.
CONCLUSION


Thus, both lido/epi and prilo/fely (maximum 3.6 mL) can be safely used in controlled diabetic patients CLINICAL RELEVANCE: The use of lidocaine associated with epinephrine did not increase glycemic levels but leads to decrease over time when associated with an anxiety reduction protocol, offering some advantage over prilocaine plus felypressin for diabetic patients.",2020,No difference was observed in the prilo/fely group among the surgical moments or between the groups regarding BP.,"['diabetic patients undergoing two anesthetic protocols during dental extractions', 'diabetic patients']","['vasoconstrictors', 'lidocaine with 1:100,000 epinephrine (Lido/Epi) and 3% prilocaine with 0.03 IU/mL felypressin (Prilo/Fely', 'prilocaine plus felypressin', 'lidocaine', 'epinephrine']","['glycemic levels', 'blood pressure (BP), heart rate (HR), saturation (SpO2), and capillary glycemic levels (Gly', 'glycemic and basal levels', 'Increased systolic BP and decreased diastolic BP', 'body parameters and glycemic levels', 'blood glucose values', 'HR and SpO2']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0277884', 'cui_str': 'Increased systolic arterial pressure'}, {'cui': 'C0277890', 'cui_str': 'Decreased diastolic arterial pressure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0547669,No difference was observed in the prilo/fely group among the surgical moments or between the groups regarding BP.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Meneses-Santos', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil. danyymeneses@yahoo.com.br.'}, {'ForeName': 'Klinger Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracibaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Anne Caroline Gercina Carvalho', 'Initials': 'ACGC', 'LastName': 'Dantas', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Ricardo Pedro', 'Initials': 'RP', 'LastName': 'da Silva', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Jaiza Samara Macena', 'Initials': 'JSM', 'LastName': 'de Araújo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracibaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, 901 Limeira Avenue, Piracibaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Liane Maciel Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Oral surgery and anesthesiology area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Bairro Sanatório, Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03327-z']
1017,31464143,Comparison of oral dydrogesterone and vaginal micronized progesterone for luteal phase support in intrauterine insemination.,"This study aims to compare the pregnancy outcomes of vaginal micronized progesterone capsules with oral dydrogesterone in subjects with unexplained subfertility who are undergoing IUI in conjunction with ovarian stimulation by using rFSH. A total of 432 patients with unexplained subfertility who underwent IUI in conjunction with ovarian stimulation were enrolled in this retrospective study. Patients were randomized into two groups: (1) dydrogesterone or (2) vaginal micronized progesterone capsules, for luteal phase support. Clinical pregnancy and live birth were the primary outcome measures of the present study. Dydrogesterone was used in 233 participants (54%) and 337 cycles, while 199 participants (46%) and 233 cycles received vaginal micronized progesterone capsule treatment. The proportion of clinical pregnancies (7.4% vs. 10.2%,  p  = .213), live births (68% vs. 73%,  p  = .286) were similar in the two groups. Oral dydrogesterone and vaginal micronized progesterone provide similar pregnancy outcomes in terms of clinical pregnancy and live birth rates in women undergoing IUI in conjunction with ovarian stimulation with rFSH. Given the simple and easy administration, lack of safety concerns and better patient tolerability, we suggest that oral dydrogesterone might be preferred for luteal phase support in IUI.",2020,Oral dydrogesterone and vaginal micronized progesterone provide similar pregnancy outcomes in terms of clinical pregnancy and live birth rates in women undergoing IUI in conjunction with ovarian stimulation with rFSH.,"['women undergoing IUI in conjunction with ovarian stimulation with rFSH', '432 patients with unexplained subfertility who underwent IUI in conjunction with ovarian stimulation', 'subjects with unexplained subfertility who are undergoing IUI in conjunction with ovarian stimulation by using rFSH', 'intrauterine insemination', '233 participants (54%) and 337 cycles, while 199 participants (46%) and 233 cycles received']","['dydrogesterone or (2) vaginal micronized progesterone capsules', 'vaginal micronized progesterone capsule treatment', 'dydrogesterone', 'Oral dydrogesterone and vaginal micronized progesterone', 'vaginal micronized progesterone capsules with oral dydrogesterone', 'oral dydrogesterone and vaginal micronized progesterone', 'Dydrogesterone']","['live births', 'clinical pregnancy and live birth rates', 'proportion of clinical pregnancies', 'Clinical pregnancy and live birth']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",233.0,0.101934,Oral dydrogesterone and vaginal micronized progesterone provide similar pregnancy outcomes in terms of clinical pregnancy and live birth rates in women undergoing IUI in conjunction with ovarian stimulation with rFSH.,"[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Taş', 'Affiliation': 'Department of Obstetrics and Gynecology, Acıbadem Mehmet Ali Aydınlar University, Acıbadem Kayseri Hospital, Kayseri, Turkey.'}, {'ForeName': 'Semih Zeki', 'Initials': 'SZ', 'LastName': 'Uludag', 'Affiliation': 'Department of Obstetrics and Gynecology, Memorial Kayseri Hospital, Kayseri, Turkey.'}, {'ForeName': 'Mustafa Ercan', 'Initials': 'ME', 'LastName': 'Aygen', 'Affiliation': 'Department of Obstetrics and Gynecology, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Yılmaz', 'Initials': 'Y', 'LastName': 'Sahin', 'Affiliation': 'Department of Obstetrics and Gynecology, Erciyes University, Kayseri, Turkey.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1655728']
1018,10553822,The influence of different intravascular volume replacement regimens on renal function in the elderly.,"UNLABELLED


Elderly patients are at risk of developing renal dysfunction. Synthetic colloids are often used perioperatively, but they may have detrimental effects on renal function. In a prospective, randomized study, we assessed the influence of different intravascular volume replacement regimens on renal function in elderly (>65 yr) and younger (< 65 yr) patients without preoperative renal dysfunction who were undergoing major abdominal surgery. Either 6% low molecular weight hydroxyethyl starch (HES) solution (mean molecular weight 70,000 D, degree of substitution 0.5; HES 70/0.5) [each group n = 10]), 6% medium-molecular weight HES (molecular weight 200,000 D, degree of substitution 0.5 (HES 200/0.5) [each group n = 10]), or modified gelatin (molecular weight 35,000 D [each group n = 10]) was administered to maintain mean arterial blood pressure >65 mm Hg and central venous pressure between 10 and 14 mm Hg. After the induction of anesthesia (T0); at the end of surgery (T1); 4 h after surgery (T2); and on the first (T3), second (T4), and third postoperative days (T5), alpha1-microglobulin (alpha1-M), N-acetyl-beta-glucosaminidase, fractional sodium clearance, and creatinine clearance (CC) were measured. Colloids (1300-3000 mL) were infused until the first postoperative day. At T0, urine concentrations of alpha1-M were higher in the elderly than in the younger patients in all groups (P < 0.05). alpha1-M remained increased only in the gelatin group. N-acetyl-beta-glucosaminidase and fractional sodium clearance were not affected during the study period in any groups. At baseline, CC was significantly higher in the younger than in the elderly patients, but CC did not decrease in any of the intravascular volume replacement groups. We conclude that intravascular volume therapy with gelatin and two different HES preparations did not adversely affect renal function in elderly patients without preoperative renal malfunction.
IMPLICATIONS


We studied the influence of three different intravascular volume replacement regimens on renal function in elderly patients without renal dysfunction who were undergoing major abdominal surgery. Two hydroxyethyl starch and one gelatin preparation were administered perioperatively to maintain stable hemodynamics. As assessed by sensitive markers of renal function, all three regimens can be used safely for volume replacement without risking significant renal dysfunction.",1999,"At T0, urine concentrations of alpha1-M were higher in the elderly than in the younger patients in all groups (P < 0.05).","['renal function in elderly (>65 yr) and younger (< 65 yr) patients without preoperative renal dysfunction who were undergoing major abdominal surgery', 'elderly patients without renal dysfunction who were undergoing major abdominal surgery', 'elderly patients without preoperative renal malfunction', 'renal function in the elderly']","['Two hydroxyethyl starch and one gelatin preparation', '6% low molecular weight hydroxyethyl starch (HES) solution', 'modified gelatin (molecular weight 35,000 D [each group n = 10]) was administered to maintain mean arterial blood pressure >65 mm Hg and central venous pressure between 10 and 14 mm Hg', 'intravascular volume replacement regimens']","['renal function', 'urine concentrations of alpha1-M', 'third postoperative days (T5), alpha1-microglobulin (alpha1-M), N-acetyl-beta-glucosaminidase, fractional sodium clearance, and creatinine clearance (CC', 'alpha1-M']","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0428640', 'cui_str': 'Central venous pressure (observable entity)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001057', 'cui_str': 'N-Acetyl-beta-D-glucosaminidase'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}]",,0.0457812,"At T0, urine concentrations of alpha1-M were higher in the elderly than in the younger patients in all groups (P < 0.05).","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kumle', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Klinikum der Stadt Ludwigshafen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Piper', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suttner', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Salopek', 'Affiliation': ''}]",Anesthesia and analgesia,[]
1019,31448063,Appraisal-based cognitive bias modification in patients with posttraumatic stress disorder: a randomised clinical trial.,"Background : Negative appraisals of the trauma and its sequelae play a crucial role in the development and maintenance of Posttraumatic Stress Disorder (PTSD). Experimental studies have shown promise in reducing negative appraisal through Cognitive Bias Modification (CBM) training.  Objective : To determine whether an online CBM training designed to modify dysfunctional appraisals is successful in reducing appraisal bias in PTSD patients.  Method : In this double-blinded 2-arm randomised clinical trial, 107 patients with PTSD were randomly allocated to active ( n  = 49) or control online CBM training ( n  = 57). Training comprised the completion of four sessions of online CBM training within one week. Change in bias, as measured by a scenario task and questionnaire (i.e. PostTraumatic Cognition Inventory), was the primary outcome. Secondary outcome included change in PTSD symptoms. Assessments took place prior to training, during training sessions, post-training and at 1- and 6-month follow-up.  Results : Intent-to-treat analysis indicated that there was no interaction effect of condition by time. Regardless of training condition, participants showed a small to moderate decline in appraisal bias and PTSD symptoms from pre- to post-training. In both conditions, bias change during training sessions was related to decline in PTSD symptomatology following training. No moderators of outcome were found.  Conclusions : There was no evidence that active training was more effective than control training in reducing dysfunctional appraisals. In both conditions, participants showed a decline in dysfunctional appraisals and PTSD symptoms following training. Importantly, bias reduction during training was related to PTSD symptom decline following training. Explanations and future research directions are discussed.",2019,To determine whether an online CBM training designed to modify dysfunctional appraisals is successful in reducing appraisal bias in PTSD patients.  ,"['107 patients with PTSD', 'patients with posttraumatic stress disorder', 'PTSD patients']","['Appraisal-based cognitive bias modification', 'control training', 'online CBM training', 'control online CBM training', ' ']","['PTSD symptomatology', 'appraisal bias and PTSD symptoms', 'change in PTSD symptoms', 'dysfunctional appraisals and PTSD symptoms', 'dysfunctional appraisals', 'scenario task and questionnaire (i.e. PostTraumatic Cognition Inventory', 'PTSD symptom decline']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",107.0,0.0360077,To determine whether an online CBM training designed to modify dysfunctional appraisals is successful in reducing appraisal bias in PTSD patients.  ,"[{'ForeName': 'Rianne A', 'Initials': 'RA', 'LastName': 'de Kleine', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Marcella L', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Ferentzi', 'Affiliation': 'Overwaal Centre of Expertise for Anxiety Disorders, OCD and PTSD, Institution for Integrated Mental Health Care Pro Persona, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Overwaal Centre of Expertise for Anxiety Disorders, OCD and PTSD, Institution for Integrated Mental Health Care Pro Persona, Nijmegen, The Netherlands.'}, {'ForeName': 'Theo G', 'Initials': 'TG', 'LastName': 'Broekman', 'Affiliation': 'Bureau Bêta, Nijmegen, The Netherlands.'}, {'ForeName': 'Eni S', 'Initials': 'ES', 'LastName': 'Becker', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Van Minnen', 'Affiliation': 'Overwaal Centre of Expertise for Anxiety Disorders, OCD and PTSD, Institution for Integrated Mental Health Care Pro Persona, Nijmegen, The Netherlands.'}]",European journal of psychotraumatology,['10.1080/20008198.2019.1625690']
1020,31448066,Differential effects of sleep on explicit and implicit memory for potential trauma reminders: findings from an analogue study.,"Background : Recent findings suggest that disruptions of sleep-related memory processing are involved in the development of posttraumatic stress symptoms. More specifically, exposure to an analogue traumatic event resulted in fewer intrusive memories, when it was followed by sleep instead of continued wakefulness. However, competing evidence suggests that sleep deprivation may reduce intrusive re-experiencing. To address these conflicting accounts, we examined how sleep - as opposed to partial sleep deprivation - modulates explicit and implicit trauma memory using an analogue procedure.  Methods : Healthy participants ( N  = 41) were assigned to a Sleep or Partial sleep deprivation group. Prior to nocturnal sleep, both groups were exposed to ""traumatic"" picture stories. After sleep or partial sleep deprivation, participants were subjected to tests of explicit and implicit memory for potential trauma reminders. Thereafter, participants completed an intrusion triggering task that was embedded in a distractor task.  Results : Analyses revealed higher explicit memory for potential trauma reminders after sleep as compared to partial sleep deprivation. No group differences were found for implicit memory. Participants responded with fewer intrusions after sleep than following partial sleep deprivation.  Conclusions : The current findings support a protective role of sleep in trauma memory processing, which may be evident after the first night of sleep post-trauma. Although more research is needed, our results corroborate the importance of promoting restful sleep in trauma-exposed individuals.",2019,No group differences were found for implicit memory.,['Healthy participants ( N  =\xa041'],"['Sleep or Partial sleep deprivation group', ' ']","['intrusive memories', 'implicit memory']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0561837', 'cui_str': 'Intrusive memories (finding)'}, {'cui': 'C0561768', 'cui_str': 'Implicit memory (observable entity)'}]",,0.040643,No group differences were found for implicit memory.,"[{'ForeName': 'M Roxanne', 'Initials': 'MR', 'LastName': 'Sopp', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Brueckner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Schäfer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Lass-Hennemann', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",European journal of psychotraumatology,['10.1080/20008198.2019.1644128']
1021,32500393,A Habit-Based Randomised Controlled Trial to Reduce Sugar-Sweetened Beverage Consumption: the Impact of the Substituted Beverage on Behaviour and Habit Strength.,"BACKGROUND


Excess sugar consumption has been linked to numerous negative health outcomes, such as obesity and type II diabetes. Reducing sugar-sweetened beverage (SSB) consumption may reduce sugar intake and thus improve health. The aim of the study was to test the impact of the potentially different rewarding nature of water or diet drinks as replacements for SSB, using a habit and implementation intention-based intervention.
METHOD


An online randomised, two-arm parallel design was used. One hundred and fifty-eight participants (mainly from the UK and USA) who regularly consumed SSBs (M age  = 31.5, 51% female) were advised to create implementation intentions to substitute their SSB with either water or a diet drink. Measures of SSB consumption, habit strength and hedonic liking were taken at baseline and at 2 months. Water or diet drink consumption was only measured at 2 months.
RESULTS


There was a large and significant reduction in SSB consumption and self-reported SSB habits for both the water and diet drink groups, but no difference between groups. There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups. Reduction in SSB hedonic liking was associated with reduced SSB consumption and habit.
CONCLUSION


This study demonstrates that an implementation intention-based intervention achieved substantial reductions in SSB consumption and habits. It also indicates that hedonic liking for SSBs and alternative drinks are associated with changes in consumption behaviour. Substituting SSBs with water or diet drinks was equally as effective in reducing SSB consumption.",2020,"There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups.","['One hundred and fifty-eight participants (mainly from the UK and USA) who regularly consumed SSBs (M age \u2009=\u200931.5, 51% female']","['Sugar-Sweetened Beverage Consumption', 'Reducing sugar-sweetened beverage (SSB) consumption', 'SSB with either water or a diet drink', 'water or diet drinks']","['SSB consumption and habit', 'SSB consumption, habit strength and hedonic liking', 'SSB consumption', 'SSB hedonic liking', 'hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit', 'SSB consumption and habits', 'SSB consumption and self-reported SSB habits']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C5197815', 'cui_str': 'Diet Beverages'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",158.0,0.0347568,"There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups.","[{'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': 'Institute of Global Health Innovation, Department of Surgery & Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Kent Street, Bentley, WA, 6102, Australia. barbara.mullan@curtin.edu.au.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Yee', 'Affiliation': 'Institute of Global Health Innovation, Department of Surgery & Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Allom', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Kent Street, Bentley, WA, 6102, Australia.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Liddelow', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Kent Street, Bentley, WA, 6102, Australia.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09906-4']
1022,31422216,Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.,"OBJECTIVES


Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age.
PATIENTS AND METHODS


Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months).
RESULTS


At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population.
CONCLUSION


In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.",2019,"In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups.","['patients with recurrent or metastatic squamous cell carcinoma of the head and neck', 'Eligible patients', 'patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65\u202fyears old; comorbidities and other age-related factors', 'patients with recurrent/metastatic SCCHN post-platinum therapy']","['nivolumab 3\u202fmg/kg every 2\u202fweeks (n\u202f=\u202f240) or IC (methotrexate, docetaxel, or cetuximab n\u202f=\u202f121', 'nivolumab versus IC', 'Nivolumab']","['overall survival (OS', 'rate of treatment-related adverse events', '30-month OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",68.0,0.213077,"In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups.","[{'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute of Emory University, 1365-C Clifton Road NE, Atlanta, GA 30322, USA. Electronic address: nfsaba@emory.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: gblumens@mdanderson.org.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, 33 Avenue de Valombrose, Nice 06189, France. Electronic address: joel.guigay@nice.unicancer.fr.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, via Venezian 1, Milan 20133, Italy. Electronic address: lisa.licitra@istitutotumori.mi.it.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Centre Leon Berard, 28 Prom. Léa et Napoléon Bullukian, Lyon 69008, France. Electronic address: jerome.fayette@lyon.unicancer.fr.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK. Electronic address: kevin.harrington@icr.ac.uk.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Kobe University Hospital Cancer Center, 7 Chome-5-2 Kusunokicho, Chuo Ward, Kobe 650-0017, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: mgillison@mdanderson.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, 5115 Centre Ave., Pittsburgh, PA 15232, USA. Electronic address: ferrisrl@upmc.edu.'}, {'ForeName': 'Vijayvel', 'Initials': 'V', 'LastName': 'Jayaprakash', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville 08648, NJ, USA. Electronic address: Vijayvel.Jayaprakash@bms.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville 08648, NJ, USA. Electronic address: Li.Li6@bms.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'University Hospital of Bonn, Sigmund-Freud-Straße 25, Bonn 53127, Germany. Electronic address: Peter.Brossart@ukbonn.de.'}]",Oral oncology,['10.1016/j.oraloncology.2019.06.017']
1023,31411972,Internal and External Validation of a 90-Day Percentage Erection Fullness Score Model Predicting Potency Recovery Following Robot-assisted Radical Prostatectomy.,"BACKGROUND


We previously reported a new post-radical prostatectomy (RP) prediction model for men with normal baseline erectile function (EF) using 90-d postoperative erection fullness to identify men who might benefit from early EF rehabilitation.
OBJECTIVE


To prospectively internally and externally validate the use of this risk assessment model in predicting 1- and 2-yr post-RP EF recovery.
DESIGN, SETTING, AND PARTICIPANTS


We randomly assigned 297 patients with a preoperative International Index of Erectile Function 5 score of 22-25 undergoing robot-assisted RP by a single surgeon to a training set and internal validation set at a ratio of 2:1. A prospective external validation set included 91 patients treated by five high-volume surgeons.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Potency was defined as erections sufficient for intercourse. To predict 1- and 2-yr potency recovery, logistic regression models were developed in the training set based on 90-d erection fullness of 0-24% or 25-100%. The resultant models were applied to the internal and external validation sets to calculate risk scores for 1- and 2-yr potency for each patient. Predictive validity was assessed using receiver operating characteristic (ROC) curves.
RESULTS AND LIMITATIONS


Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets. Internal validation confirmed strong reliability in predicting 2-yr potency outcomes (area under the ROC curve [AUC] 0.87) and external validation illustrated similar reliability in predicting 1-yr potency outcomes (AUC 0.80). In the external validation, the model predicted a mean 1-yr potency recovery rate of 39.7% (standard deviation 3.2%), compared to the actual rate of 36.26%. Limitations include the short follow-up for this cohort.
CONCLUSIONS


We present internal and external validation of a 90-d percentage erection fullness score, confirming that this metric is a robust predictor of post-RP EF recovery.
PATIENT SUMMARY


Percentage erection fullness at 3 mo after radical prostatectomy discriminates patients with a low or a high probability of recovery of erectile function (EF), which can facilitate identification of a need for early EF rehabilitation.",2020,"RESULTS AND LIMITATIONS


Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets.","['We randomly assigned 297 patients with a preoperative International Index of Erectile Function 5 score of 22-25 undergoing robot-assisted RP by a single surgeon to a training set and internal validation set at a ratio of 2:1', 'men with normal baseline erectile function (EF) using 90-d postoperative erection fullness to identify men who might benefit from early EF rehabilitation', '91 patients treated by five high-volume surgeons']","['radical prostatectomy (RP) prediction model', 'Robot-assisted Radical Prostatectomy']","['Predictive validity', 'mean 1-yr potency recovery rate', 'Percentage erection fullness']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}]",297.0,0.0434325,"RESULTS AND LIMITATIONS


Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets.","[{'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Huynh', 'Affiliation': 'Department of Urology, University of California Irvine, Orange, CA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Skarecky', 'Affiliation': 'Department of Urology, University of California Irvine, Orange, CA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilson', 'Affiliation': 'Department of Urology, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Clayon', 'Initials': 'C', 'LastName': 'Lau', 'Affiliation': 'Department of Urology, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wagner', 'Affiliation': 'Urology Department, St. Antonius-Hospital Gronau GmbH, Gronau, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Swedish Urology Group, Swedish Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Jorn H', 'Initials': 'JH', 'LastName': 'Witt', 'Affiliation': 'Urology Department, St. Antonius-Hospital Gronau GmbH, Gronau, Germany.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Ahlering', 'Affiliation': 'Department of Urology, University of California Irvine, Orange, CA, USA. Electronic address: tahlerin@uci.edu.'}]",European urology oncology,['10.1016/j.euo.2018.08.030']
1024,32140719,Supplementation with Seabuckthorn Oil Augmented in 16:1n-7t Increases Serum Trans-Palmitoleic Acid in Metabolically Healthy Adults: A Randomized Crossover Dose-Escalation Study.,"BACKGROUND


In animal models cis-palmitoleic acid (9-hexadecenoic acid; 16:1n-7c), a lipokine, improves insulin sensitivity, inflammation, and lipoprotein profiles; in humans trans-palmitoleic acid (16:1n-7t) has been associated with lower incidence of type 2 diabetes. The response to dose-escalation of supplements containing cis- and trans-palmitoleic acid has not been evaluated.
OBJECTIVES


We examined dose-escalation effects of oral supplementation with seabuckthorn oil and seabuckthorn oil augmented in 16:1n-7t on serum phospholipid fatty acids (PLFAs).
METHODS


Thirteen participants (7 women and 6 men; age 48 ± 16 y, BMI 30.4 ± 3.7 kg/m2) participated in a randomized, double-blind, crossover, dose-escalation trial of unmodified seabuckthorn oils relatively high in 16:1n-7c (380, 760, and 1520 mg 16:1n-7c/d) and seabuckthorn oils augmented in 16:1n-7t (120, 240, and 480 mg 16:1n-7t/d). Each of the 3 escalation doses was provided for 3 wk, with a 4-wk washout period between the 2 supplements. At the end of each dose period, fasting blood samples were used to determine the primary outcomes (serum concentrations of the PLFAs 16:1n-7t and 16:1n-7c) and the secondary outcomes (glucose homeostasis, serum lipids, and clinical measures). Trends across doses were evaluated using linear regression.
RESULTS


Compared with baseline, supplementation with seabuckthorn oil augmented in 16:1n-7t increased phospholipid 16:1n-7t by 26.6% at the highest dose (P = 0.0343). Supplementation with unmodified seabuckthorn oil resulted in a positive trend across the dose-escalations (P-trend = 0.0199). No significant effects of either supplement were identified on blood glucose, insulin, lipids, or other clinical measures, although this dosing study was not powered to detect such effects. No carryover or adverse effects were observed.
CONCLUSIONS


Supplementation with seabuckthorn oil augmented in 16:1n-7t and unmodified seabuckthorn oil moderately increased concentrations of their corresponding PLFAs in metabolically healthy adults, supporting the use of supplementation with these fatty acids to test potential clinical effects in humans.This trial was registered at clinicaltrials.gov as NCT02311790.",2020,"No carryover or adverse effects were observed.
","['Metabolically Healthy Adults', 'metabolically healthy adults', 'Thirteen participants (7 women and 6 men; age 48\xa0±\xa016']","['seabuckthorn oils', 'unmodified seabuckthorn oil', 'oral supplementation with seabuckthorn oil and seabuckthorn oil', 'unmodified seabuckthorn oils', 'seabuckthorn oil', 'Seabuckthorn Oil', 'supplements containing cis- and trans-palmitoleic acid']","['insulin sensitivity, inflammation, and lipoprotein profiles', 'blood glucose, insulin, lipids, or other clinical measures', 'serum phospholipid fatty acids (PLFAs', 'secondary outcomes (glucose homeostasis, serum lipids, and clinical measures', 'carryover or adverse effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0069966', 'cui_str': 'C16:1n7'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",7.0,0.142098,"No carryover or adverse effects were observed.
","[{'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Huang', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Galluccio', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Boston, MA, USA.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Mozaffarian', 'Affiliation': 'Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa060']
1025,32187092,CORR Insights®: Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.,,2020,,['1187 Patients'],['CORR Insights®'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.206245,,"[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Webb', 'Affiliation': 'M. L. Webb Hospital of the University of Pennsylvania, Department of Orthopaedic Surgery, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001220']
1026,32221735,"A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial).",,2020,,[],['Reinforced Staplers with Bare Staplers'],[],[],"[{'cui': 'C0441062', 'cui_str': 'Stapler (physical object)'}]",[],,0.176825,,"[{'ForeName': 'Brian K P', 'Initials': 'BKP', 'LastName': 'Goh', 'Affiliation': 'Department of Hepatopancreatobiliary and Transplantation Surgery, Singapore General Hospital, Singapore, Singapore. bsgkp@hotmail.com.'}]",Annals of surgical oncology,['10.1245/s10434-020-08401-0']
1027,32221739,"Reply to the Letter to the Editor ""Re: A Multicenter, Randomized, Controlled Trial Comparing Reinforced Staplers with Bare Staplers During Distal Pancreatectomy (HiSCO-07 Trial)"".",,2020,,[],['Reinforced Staplers with Bare Staplers'],[],[],"[{'cui': 'C0441062', 'cui_str': 'Stapler (physical object)'}]",[],,0.0768647,,"[{'ForeName': 'Naru', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Murakami', 'Affiliation': 'Department of Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan. mura777@hiroshima-u.ac.jp.'}]",Annals of surgical oncology,['10.1245/s10434-020-08406-9']
1028,32499026,Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial.,"OBJECTIVES


The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).
BACKGROUND


Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.
METHODS


BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.
RESULTS


Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
CONCLUSIONS


In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).",2020,"Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
","['1,334 patients randomized to treatment with', 'patients treated with', 'Subjects With Coronary Artery Lesions [BIOFLOW-V', 'Subjects']","['BP SES versus DP EES', 'DP EES', 'Versus Thin Durable-Polymer Everolimus-Eluting Stents', 'ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES', 'ultrathin-strut drug-eluting stents', 'Orsiro Sirolimus Eluting Coronary Stent System', 'Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents', 'BP SES', 'coronary revascularization with BP SES and DP EES']","['Definite or probable late or very late stent thrombosis', '3-year rate of target lesion failure', 'Safety and Effectiveness', 'target vessel myocardial infarction (MI', 'clinically driven target lesion revascularization', 'Cardiac death or MI rates', 'target vessel MI and target lesion revascularization', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",1334.0,0.0649538,"Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.
","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org.'}, {'ForeName': 'Jacques J', 'Initials': 'JJ', 'LastName': 'Koolen', 'Affiliation': 'Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Gheorghe', 'Initials': 'G', 'LastName': 'Doros', 'Affiliation': 'Department of Biostatistics and Epidemiology, Boston University School of Public Health, Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Roguin', 'Affiliation': 'Department of Cardiology, Hillel Yaffe Medical Center, Hadera, Israel.'}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Gharib', 'Affiliation': 'Charleston Area Medical Center, Charleston, West Virginia.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Cutlip', 'Affiliation': 'Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.019']
1029,32500717,Impact of Acamprosate on Chronic Tinnitus: A Randomized-Controlled Trial.,"OBJECTIVES


Tinnitus is a common and distressing otologic symptom, with various probable pathophysiologic mechanisms, such as an imbalance between excitatory and inhibitory mechanisms. Acamprosate, generally used to treat alcoholism, is a glutaminergic antagonist and GABA agonist suggested for treating tinnitus. Thus, we aimed to evaluate the efficacy and safety of acamprosate in the treatment of tinnitus.
METHODS


The current randomized-controlled trial study included 20 subjects with chronic tinnitus. After performing psycho-acoustic, psychometric and electrophysiological evaluations, all studied tinnitus subjects were randomly divided into two groups of acamprosate and placebo. The first group received oral acamprosate (two tablets of 333 mg/d, three times a day), whereas the second group was given placebo treatment (two tablets, three times a day). After the first 30 days, all evaluations were repeated for the studied groups just in the same manner before the study. Subsequently, the final results of each evaluation were compared together with the baseline values.
RESULTS


Nine studied subjects randomly received acamprosate, whereas eleven others received a placebo. There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P  = .039). For those subjects who were receiving acamprosate, a significant reduction was observed in tinnitus handicap inventory ( P  = .006), tinnitus questionnaire scores ( P  = .007), and the visual analog scores ( P  = .007) compared to the placebo group. There was a significant reduction in Action Potential latency ( P  = .048) as well as an increase in the amplitude of distortion product otoacoustic emissions at 4 kHz ( P  = .048).
CONCLUSIONS


The study results indicated a subjective relief of tinnitus as well as some degree of the electrophysiological improvement at the level of the cochlear and the distal portion of the auditory nerve among the subjects who received the acamprosate.
CLINICAL TRIAL REGISTRATION CODE


IRCT2013121115751N1.",2020,"There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P  = .039).","['20 subjects with chronic tinnitus', 'Chronic Tinnitus']","['Acamprosate', 'oral acamprosate', 'acamprosate and placebo', 'acamprosate', 'placebo']","['pitch match of tinnitus', 'Action Potential latency', 'tinnitus questionnaire scores', 'amplitude of distortion product otoacoustic emissions', 'subjective relief of tinnitus', 'psycho-acoustic tests', 'efficacy and safety', 'tinnitus handicap inventory', 'visual analog scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",20.0,0.0489289,"There was no significant improvement in the psycho-acoustic tests, except a decrease was observed in the pitch match of tinnitus ( P  = .039).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Farhadi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Salem', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alimohamad', 'Initials': 'A', 'LastName': 'Asghari', 'Affiliation': 'Skull Base Research Center, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Daneshi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mirsalehi', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Mahmoudian', 'Affiliation': 'ENT and Head & Neck Research Center and Department, the Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420930773']
1030,32495208,Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion.,"STUDY DESIGN


Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.
OBJECTIVE


We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.
METHODS


This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.
RESULTS


159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.
CONCLUSION


Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.
LEVEL OF EVIDENCE


II.",2020,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","['adolescent idiopathic scoliosis fusion', '14 sites participating in the MIMO Clinical Trial', 'adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves', 'patients and families considering fusion surgery', '159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients', 'AIS patients with Cobb\u2009>\u200945° were included']",[],"['Minimize Implants Maximize Outcomes (MIMO', 'Implant density']","[{'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}]",[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",159.0,0.204835,"Parents and patients who completely understood the trial were significantly more likely to enroll.
","[{'ForeName': 'A Noelle', 'Initials': 'AN', 'LastName': 'Larson', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. larson.noelle@mayo.edu.'}, {'ForeName': 'Lorena V', 'Initials': 'LV', 'LastName': 'Floccari', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Erickson', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sponseller', 'Affiliation': 'Johns Hopkin University, Baltimore, MD, USA.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Mayo Clinic Shared Decision Making National Resource Center, Mayo Clinic, Rochester, USA.'}, {'ForeName': 'Carl-Eric', 'Initials': 'CE', 'LastName': 'Aubin', 'Affiliation': 'Polytechnique Montreal, Montreal, QC, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Polly', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine deformity,['10.1007/s43390-020-00143-z']
1031,32498699,"The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol.","INTRODUCTION


Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to suffer renal stone disease. Flank pain from stones (renal colic) is the most common cause of emergency admission to UK urology departments. Stones most commonly develop in the lower pole of the kidney (in ~35% of cases) and here are least likely to pass without intervention. Currently there are three technologies available within the UK National Health Service to remove lower pole kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy. Current evidence indicates there is uncertainty regarding the management of lower pole stones, and each treatment has advantages and disadvantages. The aim of this trial is to determine the clinical and cost effectiveness of FURS compared with ESWL or PCNL in the treatment of lower pole kidney stones.
METHODS


The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones. Patients aged ≥16 years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) and requiring treatment for a stone ≤10 mm will be randomised to receive FURS or ESWL (RCT1), and those requiring treatment for a stone >10 mm to ≤25 mm will be randomised to receive FURS or PCNL (RCT2). Participants will undergo follow-up by questionnaires every week up to 12 weeks post-intervention and at 12 months post-randomisation. The primary clinical outcome is health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire up to 12 weeks post-intervention. The primary economic outcome is the incremental cost per quality-adjusted life year gained at 12 months post-randomisation.
DISCUSSION


The PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options.
TRIAL REGISTRATION


ISRCTN: ISRCTN98970319. Registered on 11 November 2015.",2020,"The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones.","['Flank pain from stones (renal colic', 'lower pole kidney stones', 'Patients aged ≥16\u2009years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder\xa0(CTKUB) and requiring treatment for a stone ≤10\u2009mm', 'stones in the lower pole of the kidney']","['percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy', 'ESWL or PCNL', 'FURS or PCNL (RCT2', 'PUrE (PCNL, FURS and ESWL', 'FURS', 'FURS or ESWL (RCT1', 'shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy', 'surgical interventions', 'FURS versus ESWL or PCNL']","['health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire', 'incremental cost per quality-adjusted life year gained at 12\u2009months post-randomisation']","[{'cui': 'C0016199', 'cui_str': 'Flank pain'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.185133,"The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'McClinton', 'Affiliation': 'Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK. pure@abdn.ac.uk.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Starr', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lam', 'Affiliation': 'Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernandez', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Anson', 'Affiliation': ""St George's Hospital, London, UK.""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'Stone Patient Advisory Group, Section of Endourology, British Association of Urological Surgeons, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'MacLennan', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Daron', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Turney', 'Affiliation': 'Oxford University Hospitals NHS Trust, Headley Way, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': ""Addenbrooke's NHS Trust, Hills Road, Cambridge, UK.""}]",Trials,['10.1186/s13063-020-04326-x']
1032,31440873,Mobile EGM Games: Evidence That Simulated Games Encourage Real-Money Gambling.,"Electronic gaming machines (EGMs) and other gambling-themed simulators are a popular sub-genre of video-games or ""apps"" played on mobile devices (King et al. in Comput Hum Behav 31(Supplement C):305-313, 2014). Qualitative evidence suggests that some people use gambling-themed simulators in an attempt to limit their real-money expenditure (Thorne et al. in J Gambl Issues 34:221-243, 2016), although playing such games might also encourage gambling due to anticipated enjoyment or profit. To test the potential relationship between use of simulated mobile gambling products and real-money gambling, a study was devised to explore current and retrospective accounts, as well as a prospective trial of how weekly play on EGM simulators might influence subsequent gambling. A total of 736 EGM gamblers (421 male) completed an initial scoping survey on their current and retrospective use of simulated and real-money gambling products. By invitation, 556 people (314 male) from the initial survey also volunteered in a 24 weeks follow-up study where approximately half (48.2%) were randomly assigned to play a simulated game, ""Lucky Lolly Slots"", for at least 5 min each week. Simulated gambling sessions were recorded for both Lucky Lolly Slots and any other gambling apps played by the participants. Results showed that people who had played gambling-themed EGM apps at some point in their lifetime had a higher frequency of play on real-money EGMs and were more likely to admit to current gambling problems. In addition, those people who played a simulated EGM app prior to age 13 nominated an earlier age at which they ""gambled the most"" in adolescence. In the 24 weeks trial, people's app play (number of sessions) in 1 week reliably predicted increases in real-money gambling the following week. We found no evidence that people who were trying to reduce their expenditure were contrarily influenced to gamble less as a result of their app play, with their app-sessions similarly being related to increases in expenditure. The present results suggest that gamblers who play simulated games are likely to be influenced to gamble more on real-money forms of gambling as a result of their use. The study raises particular concerns about the widespread availability and popularity of such gambling-themed simulators amongst children and adolescents.",2020,"We found no evidence that people who were trying to reduce their expenditure were contrarily influenced to gamble less as a result of their app play, with their app-sessions similarly being related to increases in expenditure.","['736 EGM gamblers (421 male) completed an initial scoping survey on their current and retrospective use of simulated and real-money gambling products', '556 people (314 male) from the initial survey also volunteered in a 24\xa0weeks follow-up study where approximately half (48.2', 'children and adolescents']","['play a simulated game, ""Lucky Lolly Slots', 'Electronic gaming machines (EGMs', 'EGM simulators', 'simulated mobile gambling products and real-money gambling']",['real-money gambling'],"[{'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}]",421.0,0.0338676,"We found no evidence that people who were trying to reduce their expenditure were contrarily influenced to gamble less as a result of their app play, with their app-sessions similarly being related to increases in expenditure.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rockloff', 'Affiliation': 'Central Queensland University, Bundaberg, Australia. m.rockloff@cqu.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Browne', 'Affiliation': 'Central Queensland University, Bundaberg, Australia.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Greer', 'Affiliation': 'Central Queensland University, Melbourne, Australia.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Armstrong', 'Affiliation': 'Central Queensland University, Adelaide, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Thorne', 'Affiliation': 'Central Queensland University, Adelaide, Australia.'}]",Journal of gambling studies,['10.1007/s10899-019-09869-6']
1033,32054255,Short-term and Medium-term Outcomes of Low Midline and Low Transverse Incisions in Laparoscopic Rectal Cancer Surgery.,"PURPOSE


Limited data exist on the use of low midline and transverse incisions for specimen extraction or stoma sites in laparoscopic rectal cancer surgery (LRCS). We compared the short-term and medium-term outcomes of these incisions and assessed whether wound complications in specimen extraction sites (SES) are increased by specimen extraction through the stoma site (SESS) in LRCS.
METHODS


From March 2010 to December 2017, 189 patients who underwent LRCS and specimen extraction through low abdominal incisions were divided into 2 groups: midline (n = 102) and transverse (n = 87), and perioperative outcomes were compared.
RESULTS


The midline group showed a higher frequency of temporary stoma formation (P = 0.001) and splenic flexure mobilization (P < 0.001) than the transverse group. The overall incisional hernia and wound infection rates in the SES were 21.6% and 25.5%, respectively, in the midline group and 26.4% and 17.2%, respectively, in the transverse group (P = 0.494 and P = 0.232, respectively). In patients who underwent SESS, the incisional hernia and wound infection rates of SES after stoma closure were 39.1% and 43.5%, respectively, in the midline group, and 35.5% and 22.6%, respectively, in the transverse group (P = 0.840 and P = 0.035, respectively).
CONCLUSION


In terms of incisional hernia and wound infection at the SES, a low midline incision may be used as a low transverse incision in patients without temporary stoma in LRCS. However, considering the high wound complication rates after stoma closure in patients with SESS in this study, SESS should be performed with caution in LRCS.",2020,The midline group showed higher the frequency of temporary stoma formation (p=0.001) and splenic flexure mobilization (p<0.001) than transverse group.,"['Methods\n\n\nFrom March 2010 to December 2017, 189 patients who underwent LRCS and specimen extraction through low abdominal incisions', 'Laparoscopic Rectal Cancer Surgery', 'laparoscopic rectal cancer surgery (LRCS', 'patients without temporary stoma in LRCS']","['low midline and transverse incisions', 'SESS', 'Low Midline and Low Transverse Incisions']","['splenic flexure mobilization', 'frequency of temporary stoma formation', 'overall incisional hernia and wound infection rates', 'incisional hernia and wound infection rates of SES after stoma closure']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0198488', 'cui_str': 'Abdomen incision'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1261209', 'cui_str': 'Transverse incision (procedure)'}]","[{'cui': 'C0227387', 'cui_str': 'Splenic Flexure'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C3665863', 'cui_str': 'Stoma closure'}]",,0.0448699,The midline group showed higher the frequency of temporary stoma formation (p=0.001) and splenic flexure mobilization (p<0.001) than transverse group.,"[{'ForeName': 'Do Hoe', 'Initials': 'DH', 'LastName': 'Ku', 'Affiliation': 'Department of Surgery, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Hyeon Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jin Yong', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': 'Department of Surgery, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}]",Annals of coloproctology,['10.3393/ac.2019.10.22']
1034,32141277,"Whey protein isolate or concentrate combined with concurrent training does not augment performance, cardiorespiratory fitness, or strength adaptations.","BACKGROUND


Protein supplementation alters both strength and endurance training adaptations individually; however less is known regarding protein supplementation during concurrent training. The primary purpose of this study was to investigate the effects of whey protein supplementation during six weeks of concurrent training on performance, cardiorespiratory fitness, and maximal strength adaptations, as well as acute hormonal and immune responses. A secondary purpose was to explore the effects of two types of whey protein powders on these latter variables.
METHODS


Thirty-one participants were randomly assigned to supplement with a placebo (PLA; N.=10), whey protein isolate (WPI; N.=10), or whey protein concentrate (WPC; N.=11) in addition to their habitual diet. Total protein intake was 1.2, 3.5, and 3.5 g/kg/day for PLA, WPI, WPC groups, respectively. Exercise testing was performed before and after 6 weeks of concurrent training. Blood samples were obtained at rest, and 5 and 60 minutes after a simulated 2000 m rowing race prior to and after training.
RESULTS


There were similar but significant improvements in cardiorespiratory fitness (PLA +7.5%; WPI +3.9%; WPC +6.9%), upper body strength (PLA +5.5%; WPI +5.1%; WPC +6.7%), lower body strength (PLA +13.6%; WPI +9.4%; WPC +14.1%) and 2000m rowing performance (PLA -2.5%; WPI -2.3%; WPC -2.3%) in all groups, P<0.05. As well, hormonal and immune responses to acute exercise were similar over time and between groups.
CONCLUSIONS


Whey protein supplementation did not differentially influence performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations following 6 weeks of concurrent training.",2020,"CONCLUSIONS


Whey protein supplementation did not differentially influence performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations following 6 weeks of concurrent training.",['Thirty-one participants'],"['whey protein supplementation', 'whey protein concentrate (WPC; n=11) in addition to their habitual diet', 'placebo (PLA']","['performance, cardiorespiratory fitness, and maximal strength adaptations', 'lower body strength', 'acute hormonal and immune responses', 'performance, cardiorespiratory fitness, or strength adaptations', 'Total protein intake', 'performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations', 'upper body strength', 'cardiorespiratory fitness']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",31.0,0.0142858,"CONCLUSIONS


Whey protein supplementation did not differentially influence performance, cardiorespiratory fitness, upper and lower body strength, immune or hormonal adaptations following 6 weeks of concurrent training.","[{'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB, Canada - forbess@brandonu.ca.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Bell', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, AB, Canada.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10314-1']
1035,31411963,Neutrophil-to-lymphocyte Ratio as a Predictive Marker of Response to Abiraterone Acetate: A Retrospective Analysis of the COU302 Study.,"BACKGROUND


The neutrophil-lymphocyte ratio (NLR) is an inexpensive and accessible prognostic marker for many cancers, including metastatic castration-resistant prostate cancer (mCRPC).
OBJECTIVE


In this study, we assess the role of NLR as a predictive biomarker through a retrospective analysis of the pivotal COU302 study of abiraterone acetate (AA) as first-line therapy for men with asymptomatic or minimally symptomatic mCRPC.
DESIGN, SETTING, AND PARTICIPANTS


The COU302 study randomized asymptomatic or minimally symptomatic men with mCRPC to receive AA plus prednisone or prednisone as first-line treatment. Baseline NLR, overall survival, radiographic progression-free survival, and prostate-specific antigen (PSA) progression-free survival were evaluated.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Descriptive statistics, as well as Kaplan-Meier and Cox survival models were used to assess the effect of baseline NLR and changes in NLR on response to AA plus prednisone versus prednisone, with adjustment for important covariates.
RESULTS AND LIMITATIONS


Among the 1082 patients who received treatment, baseline NLR values showed no significant differences according to baseline covariates except for albumin. Baseline variables were similar between dichotomous groups with an NLR cutoff of 2.5, except for a lower proportion of patients with >10 bone metastases in the NLR <2.5 group. Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models. No significant differences were seen in time to radiographic progression. In separate analyses, an increase or decrease in NLR by 2 from treatment baseline did not clearly signal subsequent lack of benefit with continued AA.
CONCLUSIONS


Our results suggest that baseline NLR may be able to predict response to AA in men with asymptomatic mCRPC but that changes in NLR during treatment are insufficient to guide treatment. Further validation studies are warranted.
PATIENT SUMMARY


In this report, we look at the ratio of circulating immune cells as a predictor of response to abiraterone acetate (AA), using data from a large trial. Our results suggest that this ratio derived from routinely obtained bloodwork can predict which patients respond better to AA.",2020,"Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models.","['The COU302 study randomized asymptomatic or minimally symptomatic men with mCRPC to receive', 'men with asymptomatic or minimally symptomatic mCRPC', '1082 patients']","['prednisone', 'placebo', 'Abiraterone Acetate', 'abiraterone acetate (AA', 'AA plus prednisone or prednisone']","['Kaplan-Meier and Cox survival models', 'Baseline NLR, overall survival, radiographic progression-free survival, and prostate-specific antigen (PSA) progression-free survival', 'time to radiographic progression', 'overall survival and PSA response', 'NLR']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]",1082.0,0.217367,"Our survival results demonstrate that higher NLR values corresponded to poorer overall survival and PSA response to AA but not to placebo, which was confirmed in our adjusted regression models.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Loubersac', 'Affiliation': 'Centre Hospitalier Universitaire Nantes, Nantes, France.'}, {'ForeName': 'Molière', 'Initials': 'M', 'LastName': 'Nguile-Makao', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pouliot', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fradet', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Toren', 'Affiliation': 'Oncology Division, Department of Surgery, Faculty of Medicine, Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Université Laval, Québec, QC, Canada. Electronic address: paul.toren@crchudequebec.ulaval.ca.'}]",European urology oncology,['10.1016/j.euo.2019.01.009']
1036,32084041,Family Management Style Improves Family Quality of Life in Children With Epilepsy: A Randomized Controlled Trial.,"INTRODUCTION


Epilepsy is a common chronic disease with transient brain dysfunction and critically influences the quality of patients' family life. The aim of this study was to analyze the effectiveness of family management style on family quality of life in children.
METHODS


We randomized 130 children to either the intervention group (n = 65) or the control group (n = 65). Family management style combined with routine care was applied in the intervention group within the first 24 hours after admission, whereas only routine care was applied in the control group. Family management style contains 3 steps: involve families into the intervention group and determine treatment plan, educate parents on how to manage their family, and monitor quality of home management. Scores on the Beach Center Family Quality of Life Scale (FQOL) of 2 groups were collected at 3 time points: within the first 24 hours after admission (T1), 6 months after discharge (T2), and 12 months after discharge (T3). Repeated-measures analysis of variance of FQOL scores was used to evaluate difference.
RESULTS


Full scores and each subscale's scores on FQOL in the control group and the intervention group at T1 had no statistical significance (P > .05). Scores on FQOL at T2 and T3 increased in the intervention group, but there was almost no change in the control group, with statistical significance between the intervention group and the control group (P < .05). Scores on FQOL at T1, T2, and T3 showed that score of subscale except parenting FQOL improved in the intervention group (P < .05), but no difference was shown in the control group (P > .05). There was no difference shown among the control group and the intervention group that interacted with time (P > .05).
CONCLUSION


The family management style can effectively improve the family quality of life in children with epilepsy, especially at the satisfaction level of family emotional well-being and disability-related support.",2020,"There was no difference shown among the control group and the intervention group that interacted with time (P > .05).
","['Children With Epilepsy', '130 children to either the intervention group (n = 65) or the control group (n = 65', 'children with epilepsy', 'children']",['family management style'],"['FQOL at T2 and T3', 'score of subscale except parenting FQOL', 'FQOL scores', ""Full scores and each subscale's scores on FQOL"", 'Beach Center Family Quality of Life Scale (FQOL', 'Family Quality of Life', 'family quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0034380'}]",130.0,0.0480615,"There was no difference shown among the control group and the intervention group that interacted with time (P > .05).
","[{'ForeName': 'Huayan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Questions or comments about this article may be directed to Lihui Zhu, MSc, RN, at 877845375@qq.com. L.Z. is Vice President of Hunan Children's Hospital, Department of Nursing, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China. Huayan Liu, MSc, RN, is Head Nurse, Department of Neurology, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China. Qingqing Song, MSc, RN, is Senior Nurse, Department of Cardiology, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China. Dan Chen, PHD, is Professor, Department of Nursing, Hunan Normal University, Changsha, Hunan, People's Republic of China. Jianhui Xie, MSc, RN, is Chief of Department of Nursing, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China. Shengnan Hu, BSc, RN, is Junior Nurse, Department of Neurology, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China. Shan Zeng, BSc, RN, is Junior Nurse, Department of Neurology, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China. Lingfang Tan, BSc, RN, is Senior Nurse, Department of Neurology, Hunan Children's Hospital, Changsha, Hunan, People's Republic of China.""}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Shengnan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Lingfang', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000497']
1037,31980638,Comparison of short-acting versus extended-release nifedipine: Effects on hemodynamics and sympathetic activity in patients with stable coronary artery disease.,"We investigated the impact of short-acting and extended release nifedipine on sympathetic activity using radiotracer methodology in patients with stable coronary artery disease in order to more accurately document the response of the sympathetic nervous system to different formulations of this dihydropyridine calcium channel antagonist. Participants were randomized to placebo, short-acting or extended release nifedipine for 7-10 days. On the final day, systemic blood pressure, cardiac filling pressures, cardiac output, plasma norepinephrine (NE) and total body NE spillover were measured at baseline (time 0) and repeated at intervals for 6 hours. There were no differences in baseline measures between groups. Following the morning dose of study medication there were no changes in hemodynamics or sympathetic activity in the placebo group. However, there was a significant fall in blood pressure and a significant increase in total body NE spillover in both nifedipine groups. Importantly, the increase in sympathetic activity in response to short-acting nifedipine began earlier (30 minutes) and was much greater than that observed in the extended release group, which occurred later (270 minutes). These findings confirm that sustained therapy with nifedipine is associated with activation of the sympathetic nervous system which is dependent on the pharmacokinetics of the formulation.",2020,Following the morning dose of study medication there were no changes in hemodynamics or sympathetic activity in the placebo group.,['patients with stable coronary artery disease'],"['short-acting versus extended-release nifedipine', 'placebo, short-acting or extended release nifedipine', 'dihydropyridine calcium channel antagonist', 'nifedipine']","['systemic blood pressure, cardiac filling pressures, cardiac output, plasma norepinephrine (NE) and total body NE spillover', 'sympathetic activity', 'total body NE spillover', 'hemodynamics or sympathetic activity', 'hemodynamics and sympathetic activity', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}]","[{'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0316431,Following the morning dose of study medication there were no changes in hemodynamics or sympathetic activity in the placebo group.,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada. john.parker@uhn.ca.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""D' Iorio"", 'Affiliation': 'Division of Cardiology, Department of Medicine Mount Sinai Hospital and The Lunenfeld-Tanenbaum Research Institute, University of Toronto, Ontario, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'Division of Cardiology, Department of Medicine Mount Sinai Hospital and The Lunenfeld-Tanenbaum Research Institute, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Corey B', 'Initials': 'CB', 'LastName': 'Toal', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada.'}]",Scientific reports,['10.1038/s41598-019-56890-1']
1038,32497605,The duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content.,"BACKGROUND


Maternal oxygen (O 2 ) administration is a commonly performed intrauterine resuscitation technique though to improve fetal oxygenation. However, hyperoxygenation is known to be harmful in both neonates and adults. Currently, there are no formal recommendations on whether a certain dose or duration of O 2  may be most helpful in improving umbilical cord gases or neonatal outcomes.
OBJECTIVE


We tested the hypothesis that prolonged supplemental O 2  exposure during labor is associated with increased umbilical cord O 2  concentrations.
STUDY DESIGN


This was a planned secondary analysis of a randomized noninferiority trial comparing O 2  with room air in laboring patients. Patients were randomized to receive either 10 L/min O 2  or room air at any point during active labor when they developed a category II fetal heart tracing that would otherwise require resuscitation. The primary outcome variable for this analysis was partial pressure of O 2  in the umbilical vein. The secondary outcome variable was partial pressure of O 2  in the umbilical artery. These outcome variables were compared between patients with short durations of O 2  exposure and those with long durations of O 2  exposure, defined as <75th percentile and ≥75th percentile of duration, respectively. The outcomes were also compared among the groups that received room air, O 2  for short durations, and O 2  for long durations.
RESULTS


Among the 99 patients with paired and validated cord gases who were included in this analysis, the partial pressure of O 2  in the umbilical vein was significantly lower in patients who received O 2  supplementation for longer durations than in those who received O 2  for shorter durations (median interquartile range 25.5 [21.5-33] vs 32.5 [26.5-37.5] mm Hg; P<.03). There was no difference in the partial pressure of O 2  in the umbilical artery or other cord gases between the short and long duration O 2  supplementation groups. Other methods of intrauterine resuscitation were similar between the short and long duration O 2  supplementation groups. There was no difference in the partial pressure of O 2  in the umbilical artery or in the umbilical vein when the room air, short duration O 2  supplementation, and long duration O 2  supplementation groups were compared.
CONCLUSION


Longer durations of O 2  exposure are not associated with a higher partial pressure of O 2  in the umbilical cord. In fact, patients with longer durations of O 2  exposure had lower partial pressure of O 2  in the umbilical vein, suggesting impaired placental O 2  transfer with prolonged O 2  exposure.",2020,"There was no difference in UA or UV pO 2  when compared between RA, short duration O 2 , and long duration O 2  groups.
",['laboring patients'],[],"['umbilical vein (UV) pO 2 ', 'duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content', 'UA pO 2  or other cord gases', 'umbilical artery (UA) pO 2 ']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0523806', 'cui_str': 'Oxygen measurement'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}]",99.0,0.283401,"There was no difference in UA or UV pO 2  when compared between RA, short duration O 2 , and long duration O 2  groups.
","[{'ForeName': 'Virginia Y', 'Initials': 'VY', 'LastName': 'Watkins', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO. Electronic address: Watkinsv@wustl.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Martin', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell Medical School, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University, Bloomington, IN.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell Medical School, The University of Texas at Austin, Austin, TX.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.056']
1039,32441658,A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.,"BACKGROUND


Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes.
OBJECTIVE


This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated.
METHODS


Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies.
RESULTS


The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F 2,146.6 =9.99; P<.001), which was similar for CAU and the intervention group (F 1,149.9 =0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F 1,149.0 =0.48; P=.07).
CONCLUSIONS


The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281.",2020,"Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02).","['Patients With Cardiovascular Disease', 'Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the']","['Personalized eHealth Intervention', 'Do CHANGE intervention or care as usual (CAU', 'behavioral program in combination with ecological momentary assessment and intervention technologies']","['increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life', 'lifestyle scores', 'behavioral flexibility', 'Quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.13002,"Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02).","[{'ForeName': 'Eva Rosalinde', 'Initials': 'ER', 'LastName': 'Broers', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Willem Johan', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Denollet', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Widdershoven', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}, {'ForeName': 'Mart', 'Initials': 'M', 'LastName': 'Wetzels', 'Affiliation': 'University of Technology Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Idowu', 'Initials': 'I', 'LastName': 'Ayoola', 'Affiliation': 'University of Technology Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jimenez', 'Affiliation': 'Badalona Serveis Assistencials, Badalona, Spain.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Habibovic', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, Netherlands.'}]",Journal of medical Internet research,['10.2196/14570']
1040,31432723,Healthcare resource utilization and costs in the 12 months following hospitalization for respiratory syncytial virus or unspecified bronchiolitis among infants.,"Aims:  To examine healthcare resource utilization (HRU) and costs within 12 months after hospitalization for respiratory syncytial virus (RSVH) or unspecified bronchiolitis (UBH) in infants. Materials and methods:  Infants born July 1, 2009-June 30, 2015 were identified in the MarketScan Medicaid and Commercial databases and were assigned to one of three cohorts: RSVH (with/without UBH), UBH, or comparator (no RSVH or UBH). Each infant was identified as pre-term (5 groups) or term (2 groups) based on weeks gestational age (wGA). Index dates were the first admission dates for RSVH or UBH infants and were randomly assigned to comparator infants based on time from birth to index in the RSVH cohort. HRU, all-cause costs, and incremental cost differences between hospitalized and comparator infants were assessed over 12 months post-index with and without the index hospitalization. Results were propensity score weighted to balance pre-index characteristics across hospitalization cohorts. Results:  This study identified 15,872 RSVH infants, 6,081 UBH infants, and 986,087 comparator infants in the Medicaid population and 5,755 RSVH infants, 1,888 UBH infants, and 696,302 comparator infants in the commercial population. HRU in follow-up was greater for RSVH and UBH infants relative to comparator infants in both populations, including hospitalizations (commercial: 7.4%, 11.0%, 1.7%; Medicaid: 12.3%, 15.3%, 3.2%) and emergency department visits (commercial: 33.0%, 33.3%, 17.2%; Medicaid: 65.8%, 68.5%, 51.4%). HRU was highest among RSVH and UBH infants born at <29 wGA. Hospitalized infants had numerically higher follow-up costs than comparator infants, with incremental differences reaching $19,896 among Medicaid UBH infants and $37,417 among commercial RSVH infants. Limitations:  RSV/UB may be miscoded in claims data. Conclusions:  Infants hospitalized for RSV or UB largely had greater subsequent HRU and costs in the first year after index hospitalization than comparator infants. Absolute and incremental follow-up costs relative to comparator infants were highest among infants <29 wGA.",2020,"HRU in follow-up was greater for RSVH and UBH infants relative to comparator infants in both populations, including hospitalizations (commercial: 7.4%, 11.0%, 1.7%; Medicaid: 12.3%, 15.3%, 3.2%) and emergency department visits (commercial: 33.0%, 33.3%, 17.2%; Medicaid: 65.8%, 68.5%, 51.4%).","['respiratory syncytial virus (RSVH) or unspecified bronchiolitis (UBH) in infants', 'respiratory syncytial virus or unspecified bronchiolitis among infants', '15,872 RSVH infants, 6,081 UBH infants, and 986,087 comparator infants in the Medicaid population and 5,755 RSVH infants, 1,888 UBH infants, and 696,302 comparator infants in the commercial population']","['RSVH (with/without UBH), UBH, or comparator (no RSVH or UBH']","['subsequent HRU and costs', 'emergency department visits', 'HRU']","[{'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",,0.0594837,"HRU in follow-up was greater for RSVH and UBH infants relative to comparator infants in both populations, including hospitalizations (commercial: 7.4%, 11.0%, 1.7%; Medicaid: 12.3%, 15.3%, 3.2%) and emergency department visits (commercial: 33.0%, 33.3%, 17.2%; Medicaid: 65.8%, 68.5%, 51.4%).","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Ledbetter', 'Affiliation': 'Pediatric Pulmonology, Childrens Hospital at Erlanger, Chattanooga, TN, USA.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Brannman', 'Affiliation': 'US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Wade', 'Affiliation': 'Wade Outcomes Research and Consulting, Salt Lake City, UT, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Gonzales', 'Affiliation': 'US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kong', 'Affiliation': 'Life Sciences, IBM Watson Health, Cambridge, MA, USA.'}]",Journal of medical economics,['10.1080/13696998.2019.1658592']
1041,7684579,Influence of different intravascular volume therapies on platelet function in patients undergoing cardiopulmonary bypass.,"The influence of four different kinds of intravascular volume replacement on platelet function was investigated in 60 patients undergoing elective aortocoronary bypass grafting using cardiopulmonary bypass (CPB). In a randomized sequence, high-molecular weight hydroxyethyl starch solution (HMW-HES, mean molecular weight [Mw] 450,000 d), low-molecular weight HES (LMW-HES, Mw 200,000 d), 3.5% gelatin or 5% albumin were infused preoperatively to double reduced filling pressure (pulmonary capillary wedge pressure [PCWP] < 5 mm Hg). Fifteen untreated patients served as a control. Platelet function was assessed by aggregometry using turbidometric technique (inductors: ADP, epinephrine, collagen). Maximum aggregation, maximum gradient of aggregation, and platelet volume were measured before, during, and after CPB until the first postoperative day. HMW-HES 840 +/- 90 mL, LMW 850 +/- 100 mL, gelatin 950 +/- 110 mL, and albumin 810 +/- 100 mL were given preoperatively. Maximum platelet aggregation (ranging from -23% to -44% relative from baseline value) and maximum gradient of platelet aggregation (ranging from -26% to -45% relative from baseline values) were reduced only in the HMW-HES patients. After CPB, aggregometry also was impaired most markedly in these patients. The other volume groups showed less reduction in platelet aggregation and were similar to the untreated control. On the first postoperative day, aggregation variables had returned almost to baseline in all patients. Platelet volume was the same among the groups within the investigation period. Postbypass blood loss was highest in the HMW-HES group (890 +/- 180 mL). There was significant (P < 0.04) correlation in this group between blood loss and change in platelet aggregation.(ABSTRACT TRUNCATED AT 250 WORDS)",1993,Maximum platelet aggregation (ranging from -23% to -44% relative from baseline value) and maximum gradient of platelet aggregation (ranging from -26% to -45% relative from baseline values) were reduced only in the HMW-HES patients.,"['60 patients undergoing elective aortocoronary bypass grafting using cardiopulmonary bypass (CPB', 'patients undergoing cardiopulmonary bypass', 'Fifteen untreated patients served as a control']","['HMW-HES 840 ', 'high-molecular weight hydroxyethyl starch solution (HMW-HES, mean molecular weight', 'LMW 850 ', 'intravascular volume therapies', 'gelatin or 5% albumin were infused preoperatively to double reduced filling pressure (pulmonary capillary wedge pressure [PCWP', 'HMW-HES', 'intravascular volume replacement', 'albumin 810 ', 'gelatin 950 ']","['Postbypass blood loss', 'blood loss and change in platelet aggregation.(ABSTRACT TRUNCATED AT 250 WORDS', 'Maximum aggregation, maximum gradient of aggregation, and platelet volume', 'Maximum platelet aggregation', 'platelet aggregation', 'Platelet volume', 'platelet function', 'maximum gradient of platelet aggregation', 'Platelet function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0587370', 'cui_str': 'Aortocoronary bypass grafting (procedure)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement (procedure)'}, {'cui': 'C4708800', 'cui_str': '950'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C1562590', 'cui_str': 'Platelet volume'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}]",60.0,0.160061,Maximum platelet aggregation (ranging from -23% to -44% relative from baseline value) and maximum gradient of platelet aggregation (ranging from -26% to -45% relative from baseline values) were reduced only in the HMW-HES patients.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Boldt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Justus-Liebig-University Giessen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Knothe', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zickmann', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Andres', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dapper', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hempelmann', 'Affiliation': ''}]",Anesthesia and analgesia,[]
1042,32210370,"Correction: Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],"['extinction learning with D-cycloserine', 'placebo']",['return of fear'],[],"[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0893736,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0658-3']
1043,32503606,Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics.,"BACKGROUND


Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal breast cancer for every 5 kg/m 2  increase in body mass index (BMI). Despite this evidence there are few lifestyle programmes directed towards breast cancer risk reduction. This paper describes the process of optimising of the ActWELL programme which aims to support weight management in women invited to attend routine National Health Service (NHS) breast screening clinics.
METHODS


A feasibility study of a prototype programme aiming to change lifestyle behaviours was successfully undertaken. The programme used educational approaches and behaviour change techniques delivered by lifestyle coaches using individual face to face meetings and telephone sessions. To optimise the intervention for a definitive randomised controlled trial of weight management, data from the feasibility trial, focus group discussions conducted with the target population, feedback from the trial public advisory group and comments from peer reviewers were obtained. Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
RESULTS


The results from the feasibility trial were considered appropriate for moving on to a full trial with 70% of participants finding the programme acceptable. The primary outcomes (weight loss and physical activity) provided an important focus for design input from the target group. The contributions highlighted the need to review programme duration, coach contact time, content and use of behaviour change techniques and communications generally (e.g. science and evidence, non-judgemental approaches and avoiding guilt). In addition, the need for emphasis on support rather than education became apparent. The recommendations from peer reviewers focussed on the magnitude of effort required to achieve the intended weight loss and weight loss maintenance. Implementation science supported the use of the capability/opportunity/motivation (COM-B)model in overall design.
CONCLUSIONS


The optimisation process has facilitated the development and evaluation of a programme that enables the delivery of a promising intervention to achieve weight management in post-menopausal women.
TRIAL REGISTRATION


ISRCTN: ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered.",2020,"Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
","['women attending routine NHS breast screening clinics', 'women invited to attend routine National Health Service (NHS) breast screening clinics', 'post-menopausal women']","['lifestyle intervention programme', 'prototype programme']","['weight loss and physical activity', 'body mass index (BMI']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0584181,"Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group.
","[{'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK. a.s.anderson@dundee.ac.uk.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Craigie', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gallant', 'Affiliation': 'Centre for Research into Cancer Prevention and Screening / Tayside Cancer Centre, Division of Cancer Research, University of Dundee, Level 7, Mailbox 7, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'McAdam', 'Affiliation': ""Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'E Jane', 'Initials': 'EJ', 'LastName': 'Macaskill', 'Affiliation': 'Department of Breast Surgery, NHS Tayside, Ninewells Hospital & Medical School, Dundee, DD1 9SY, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McKell', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': ""Physical Activity for Health Research Centre, Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, St Leonard's Land, Holyrood Road, Edinburgh, EH8 8AQ, UK.""}, {'ForeName': 'Ronan E', 'Initials': 'RE', 'LastName': ""O'Carroll"", 'Affiliation': 'Division of Psychology, School of Natural Sciences, University of Stirling, Stirling, FK9 4LA, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, G12 8TA, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Stead', 'Affiliation': 'Institute for Social Marketing, University of Stirling, Stirling, FK9 4LA, Scotland, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.'}]",Trials,['10.1186/s13063-020-04405-z']
1044,32513646,Development and Preliminary Evaluation of the Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial.,"BACKGROUND


Pulmonary rehabilitation is one of the main interventions to reduce the use of health resources, and it promotes a reduction in chronic obstructive pulmonary disease (COPD) costs. mHealth systems in COPD aim to improve adherence to maintenance programs after pulmonary rehabilitation by promoting the change in attitude and behavior necessary for patient involvement in the management of the disease.
OBJECTIVE


This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in COPD patients.
METHODS


COPD patients from three hospitals were randomized to a control group or an intervention group (HappyAir group). Patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. After completion of the process, only the HappyAir group completed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The control group only underwent the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire, and EuroQOL-5D), exercise capacity (6-Minute Walk Test), and lung function.
RESULTS


In total, 44 patients were recruited and randomized in the control group (n=24) and HappyAir group (n=20). Eight patients dropped out for various reasons. The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HappyAir group, which was statistically different compared with the control group at 12 months (56.1 [SD 4.0] vs 44.0 [SD 13.6]; P=.004) after pulmonary rehabilitation.
CONCLUSIONS


mHealth systems designed for COPD patients improve adherence to maintenance programs as long as they are accompanied by disease awareness and patient involvement in management.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04479930; https://clinicaltrials.gov/ct2/show/NCT04479930.",2020,"The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR.
","['44 patients were recruited and randomized in the CG (n=24) and HG (n=20', 'COPD patients from three hospitals', 'COPD patients', 'COPD Patients']","['control group (CG) or an intervention group (HappyAir™ group [HG', 'mHealth Web-based Platform (HappyAir™', 'integrated care plan based on an mHealth web-based platform (HappyAir™', 'Maintenance Program', 'Pulmonary rehabilitation (PR']","['adherence to physical activity (Morisky-Green Test), quality of life (CAT, SGRQ and EuroQOL-5D), exercise capacity (6MWT) and lung function', 'adherence', 'Adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",44.0,0.0421553,"The CAP FISIO questionnaire results showed an improvement in adherence during follow-up period for the HG, which was statistically different compared to the CG at 12 months (56.1±4 vs 44±13.6; P=.004) after PR.
","[{'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Jiménez-Reguera', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Maroto López', 'Affiliation': 'Lovexair Foundation, Madrid, Spain.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Fitch', 'Affiliation': 'Lovexair Foundation, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Juarros', 'Affiliation': 'Hospital Universitario 12 de octubre, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Sánchez Cortés', 'Affiliation': 'Hospital Universitario 12 de octubre, Madrid, Spain.'}, {'ForeName': 'Juan Luis', 'Initials': 'JL', 'LastName': 'Rodríguez Hermosa', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Calle Rubio', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Hernández Criado', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Angulo-Díaz-Parreño', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Vilaró', 'Affiliation': 'Ramon Llull University, Barcelona, Spain.'}]",JMIR mHealth and uHealth,['10.2196/18465']
1045,32441571,Effects of inverse ratio ventilation combined with lung protective ventilation on pulmonary function in patients with severe burns for surgery.,"OBJECTIVE


To investigate the effects of inverse ratio ventilation combined with lung-protective ventilation on pulmonary function and inflammatory factors in severe burn patients undergoing surgery.  Populations and Methods : Eighty patients with severe burns undergoing elective surgery were divided randomly into two groups: control (CG,  n  = 40) and experiment (EG,  n  = 40). The CG had conventional ventilation, whereas the EG were ventilated with tidal volume (TV) of 6-8 ml/kg, I (inspiration): E (expiration) of 2:1, and positive end-expiratory pressure (PEEP) 5 cm H2O. The following variables were evaluated before (T0), 1 h after start of surgery (T1) and after surgery (T2): oxygenation index (OI), partial pressure of carbon dioxide (PaCO 2 ), TV, peak airway pressure (Ppeak), mean airway pressure (Pmean), PEEP, pulmonary dynamic compliance (Cdyn), alveolar-arterial difference of oxygen partial pressure D(A-a)O 2 , lactic acid (Lac), interleukin (IL)-6 and IL-10, and lung complications.  Results : At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG. At the end of the surgery, the Lac was significantly smaller in the EG than in the CG (1.28 ± 0.19 vs. 1.40 ± 0.23 mmol/L). Twenty-four hours after the surgery, significantly more patients had hypoxemia (27.5 vs. 10.0%), increased expectoration (45.0 vs. 22.5%), increased lung texture or exudation (37.5 vs. 17.5%) in the CG than in the EG.  Conclusions : Inverse ratio ventilation combined with lung-protective ventilation can reduce Ppeak, increase Pmean and Cdyn, improve the pulmonary oxygenation function, and decrease ILs in severe burn surgery patients.",2020,"At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG.","['severe burn patients undergoing surgery', 'Populations and Methods ', 'severe burn surgery patients', 'Eighty patients with severe burns undergoing elective surgery', 'patients with severe burns for surgery']","['inverse ratio ventilation combined with lung-protective ventilation', 'inverse ratio ventilation combined with lung protective ventilation', 'Inverse ratio ventilation combined with lung-protective ventilation']","['pulmonary function and inflammatory factors', 'increased lung texture or exudation ', 'OI, Pmean and Cdyn', 'oxygenation index (OI), partial pressure of carbon dioxide (PaCO 2 ), TV, peak airway pressure (Ppeak), mean airway pressure (Pmean), PEEP, pulmonary dynamic compliance (Cdyn), alveolar-arterial difference of oxygen partial pressure D(A-a)O 2 , lactic acid (Lac), interleukin (IL)-6 and IL-10, and lung complications', 'pulmonary oxygenation function', 'increased expectoration', 'pulmonary function', 'Lac', 'TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10', 'hypoxemia ']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",80.0,0.0594429,"At T1 and T2 time points, the OI, Pmean and Cdyn were significantly greater in the EG than in the CG while the TV, Ppeak, D(A-a)O 2 , IL-6 and IL-10 were significantly smaller in the EG than in the CG.","[{'ForeName': 'Yan-Chao', 'Initials': 'YC', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Huai', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Shu-Zhen', 'Initials': 'SZ', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Cao', 'Affiliation': 'Respiratory Department, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}, {'ForeName': 'Bu-Lang', 'Initials': 'BL', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Shijiazhuang First Hospital, Hebei Medical University , Shijiazhuang, Hebei Province, China.'}]",The Libyan journal of medicine,['10.1080/19932820.2020.1767276']
1046,5338039,"Trial of thiethylperazine (""torecan"") for the prevention of postoperative vomiting.",,1967,,[],"['thiethylperazine (""torecan']",['postoperative vomiting'],[],"[{'cui': 'C0039865', 'cui_str': 'Thiethylperazine'}, {'cui': 'C0723786', 'cui_str': 'Torecan'}]","[{'cui': 'C0520905', 'cui_str': 'Postoperative Emesis'}]",,0.0162748,,"[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Rae', 'Affiliation': ''}]",The Medical journal of Australia,[]
1047,5338146,"A controlled trial of butyrylperazine (""Randolectil"") in senile dementia.",,1967,,['senile dementia'],"['butyrylperazine (""Randolectil']",[],"[{'cui': 'C0011268', 'cui_str': 'Senile dementia (disorder)'}]","[{'cui': 'C0006481', 'cui_str': '1-Butanone, 1-(10-(3-(4-methyl-1-piperazinyl)propyl)-10H-phenothiazin-2-yl)-'}]",[],,0.0489259,,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Juvars', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': ''}]",The Medical journal of Australia,[]
1048,31421011,Early weaning versus prolonged administration of aqueous suppressants for prevention of hyperencapsulation in paediatric Ahmed glaucoma valve.,"PURPOSE


To investigate the role of early and prolonged administration of aqueous suppressants in reduction of hyperencapsulation and intraocular pressure (IOP) control after paediatric Ahmed glaucoma valve (AGV) implantation.
METHODS


A prospective randomized interventional study recruited children who had AGV implantation for paediatric glaucoma. All patients received postoperative Timolol 0.5% for either 12 months (Group A) or 3 months (Group B). Additional IOP-reducing medications were added if IOP exceeded 21 mmHg or hyperencapsulation developed in either group. Primary outcome measures were rate of hyperencapsulation and reduction of IOP.
RESULTS


Eighty sex children completed the 12-month follow-up visits. Baseline IOP was significantly reduced from 31.95 ± 9.1 to 16.94 ± 3.4 mmHg at 12 months in Group A and from 32.7 ± 7.4 to 19.85 ± 6.9 mmHg at 12 months in Group B. IOP was significantly lower in Group A than B at 6-, 9- and 12-month follow-up visits. In the first 4 months, the hyperencapsulation rate was similar in both Group A (six eyes, 13.3%) and Group B (seven eyes, 17.1%). However, the hyperencapsulation rate was significantly lower in Group A than B at both 6 months (22.5% versus 36.6%) and 12 months (31.1% versus 46.3%). Anti-glaucoma medications were significantly lower in Group A than B at both 6 months (1.3 versus 3.2 drugs) and 12 months (1.5 versus 3.6 drugs).
CONCLUSION


Early and prolonged use of aqueous suppressants significantly reduced the rate of hyperencapsulation and provided better IOP control after paediatric AGV implantation.",2020,6.9 mmHg at 12 months in Group B. IOP was significantly lower in Group A than B at,"['paediatric Ahmed glaucoma valve', 'Eighty sex children', 'children who had AGV implantation for paediatric glaucoma', 'after paediatric Ahmed glaucoma valve (AGV) implantation']","['Early weaning versus prolonged administration of aqueous suppressants', 'postoperative Timolol']","['hyperencapsulation rate', 'Anti-glaucoma medications', 'rate of hyperencapsulation', 'Baseline IOP', 'rate of hyperencapsulation and reduction of IOP', 'hyperencapsulation and intraocular pressure (IOP) control']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}]","[{'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",80.0,0.0395232,6.9 mmHg at 12 months in Group B. IOP was significantly lower in Group A than B at,"[{'ForeName': 'Mahmoud F', 'Initials': 'MF', 'LastName': 'Rateb', 'Affiliation': 'Department of Ophthalmology, Assiut University Hospital, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Zeiad H', 'Initials': 'ZH', 'LastName': 'Eldaly', 'Affiliation': 'Department of Ophthalmology, Assiut University Hospital, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Wael M', 'Initials': 'WM', 'LastName': 'Soliman', 'Affiliation': 'Department of Ophthalmology, Assiut University Hospital, Assiut University, Assiut, Egypt.'}]",Acta ophthalmologica,['10.1111/aos.14220']
1049,31412001,Cost-effectiveness of Pembrolizumab as Second-line Therapy for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma in Sweden.,"BACKGROUND


Urothelial carcinoma (UC) is the most common subtype of bladder cancer. The randomized phase 3 KEYNOTE-045 trial showed that pembrolizumab, used as second-line therapy significantly prolonged overall survival with fewer treatment-related adverse events than chemotherapy for advanced UC. Pembrolizumab has been approved by the European Medicines Agency for the treatment of locally advanced or metastatic UC in adults who have received platinum-containing chemotherapy. Many European countries use cost-effectiveness analysis to inform reimbursement decisions.
OBJECTIVE


To assess the cost-effectiveness of pembrolizumab as second-line therapy for the treatment of advanced UC from a Swedish health care perspective.
DESIGN, SETTING, AND PARTICIPANTS


We developed a partitioned-survival model to assess the costs and effectiveness of pembrolizumab compared with vinflunine (base case), paclitaxel, or docetaxel monotherapy in patients with advanced UC over a 15-yr time horizon. We obtained Kaplan-Meier estimates for survival endpoints, adverse events, and utility data from KEYNOTE-045.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


We performed parametric extrapolations to estimate overall and progression-free survival beyond the clinical trial period. Swedish costs and utility weights were used to estimate total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We performed deterministic and probabilistic sensitivity analyses to assess the robustness of the model results.
RESULTS AND LIMITATIONS


In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of €69852 and an ICER of €50529/QALY gained versus vinflunine monotherapy. ICERs for other chemotherapies were €81356/QALY for pembrolizumab versus paclitaxel or docetaxel monotherapy, and €71924/QALY for pembrolizumab versus paclitaxel, docetaxel, or vinflunine monotherapy. Long-term follow-up from KEYNOTE-045 and real-world data are needed to validate the extrapolations.
CONCLUSIONS


The results indicate that pembrolizumab improves survival, increases QALYs, and is cost-effective as second-line therapy at a willingness-to-pay threshold of €100000/QALY for the treatment of advanced UC.
PATIENT SUMMARY


To date, pembrolizumab is the only treatment associated with a significant overall survival benefit compared with chemotherapy in a randomized controlled trial as second-line therapy for advanced urothelial carcinoma. Our trial-based cost-effectiveness analysis suggests that pembrolizumab is a cost-effective option over chemotherapy in patients with advanced urothelial carcinoma after platinum-based therapy in Sweden.",2020,"In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of €69852 and an ICER of €50529/QALY gained versus vinflunine monotherapy.","['Urothelial carcinoma (UC', 'patients with advanced UC over a 15-yr time horizon', 'locally advanced or metastatic UC in adults who have received platinum-containing chemotherapy', 'advanced urothelial carcinoma', 'advanced UC from a Swedish health care perspective', 'patients with advanced urothelial carcinoma after platinum-based therapy in Sweden', 'Locally Advanced or Metastatic Urothelial Carcinoma in Sweden']","['Pembrolizumab', 'pembrolizumab', 'pembrolizumab versus paclitaxel, docetaxel, or vinflunine monotherapy', 'Pembrolizumab as Second-line Therapy', 'pembrolizumab versus paclitaxel or docetaxel monotherapy', 'vinflunine (base case), paclitaxel, or docetaxel monotherapy', 'chemotherapy']","['Swedish costs and utility weights', 'overall survival', 'survival, increases QALYs, and is cost-effective', 'mean survival gain', 'cost-effectiveness', 'total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs']","[{'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0672663', 'cui_str': 'vinflunine'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.10683,"In the base-case analysis, pembrolizumab resulted in a mean survival gain of 1.66 years (1.38 QALYs) at an incremental cost of €69852 and an ICER of €50529/QALY gained versus vinflunine monotherapy.","[{'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Srivastava', 'Affiliation': 'Complete HEOR Solutions, North Wales, PA, USA.'}, {'ForeName': 'Vimalanand S', 'Initials': 'VS', 'LastName': 'Prabhu', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Zarabi', 'Affiliation': 'Merck Sharp & Dohme, Stockholm, Sweden.'}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA. Electronic address: yichen.zhong@merck.com.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Pellissier', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Rodolfo F', 'Initials': 'RF', 'LastName': 'Perini', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'de Wit', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ronac', 'Initials': 'R', 'LastName': 'Mamtani', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",European urology oncology,['10.1016/j.euo.2018.09.012']
1050,32510734,"Azithromycin and COVID-19: Prompt early use at first signs of this infection in adults and children, an approach worthy of consideration.","The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19. Initial enthusiasm for the combination of hydroxychloroquine and azithromycin has abated. However, as a result of positive clinical experience with azithromycin used alone during the first few days of the flu-like illness caused by this coronavirus, we recommend formal clinical trials using azithromycin early in the course of a COVID-19 infection. There is one clinical trial initiated, the individually randomized, telemedicine-based, ""Azithromycin for COVID-19 Treatment in Outpatients Nationwide"" based at the University of California San Francisco. This placebo-controlled trial is designed to determine the efficacy of a single 1.2-g dose of oral azithromycin to prevent COVID-19 patient progression to hospitalization. We recommend formal clinical trials of azithromycin in its prepackaged form at the first sign of COVID-19 infection in adults and children, using an initial adult dose of 500 mg followed by 250 mg per day for 4 days, a total cumulative dose of 1.5 g, and for children 5 to 18 years of age, 10 mg/kg on the first day followed by 5 mg/kg for 4 days.",2020,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"['Adults and Children', 'Outpatients Nationwide (ACTION)"" based at the University of California San Francisco', 'adults and children']","['hydroxychloroquine and azithromycin', 'telemedicine-based, ""Azithromycin', 'Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0479328,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Professor of Dermatology and Pathology, Rutgers University New Jersey Medical School, Newark, New Jersy, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Suskind', 'Affiliation': 'Professor of Pediatrics and Founding Dean Emeritus, California University of Science of Medicine, San Bernardino, California, USA.'}]",Dermatologic therapy,['10.1111/dth.13785']
1051,32441655,"A Blended Learning System to Improve Motivation, Mood State, and Satisfaction in Undergraduate Students: Randomized Controlled Trial.","BACKGROUND


Smartphone-based learning, or mobile learning (m-learning), has become a popular learning-and-teaching strategy in educational environments. Blended learning combines strategies such as m-learning with conventional learning to offer continuous training, anytime and anywhere, via innovative learning activities.
OBJECTIVE


The main aim of this work was to examine the short-term (ie, 2-week) effects of a blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app-on knowledge, motivation, mood state, and satisfaction among undergraduate students enrolled in a health science first-degree program.
METHODS


The study was designed as a two-armed, prospective, single-blind, randomized controlled trial. Subjects who met the inclusion criteria were randomly assigned to either the intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning). For both groups, the educational program involved 13 lessons on basic health science. The iPOT app is a hybrid, multiplatform (ie, iOS and Android) smartphone app with an interactive teacher-student interface. Outcomes were measured via multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence).
RESULTS


A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group. No difference was seen between the two groups in terms of theoretical knowledge gain (P=.92). However, the intervention group subjects returned significantly higher scores than the control group subjects for all postintervention assessed items via the motivation questionnaire (all P<.001). Analysis of covariance (ANCOVA) revealed a significant difference in the confusion and bewilderment component in favor of the intervention group (P=.01), but only a trend toward significance in anger and hostility as well as total score. The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001). Finally, the intervention group subjects who were frequent users of the app showed stronger motivation, as well as increased perception of greater gains in their English-language competence, than did infrequent users.
CONCLUSIONS


The blended learning method led to significant improvements in motivation, mood state, and satisfaction compared to traditional teaching, and elicited statements of subjective improvement in terms of competence in English.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03335397; https://clinicaltrials.gov/ct2/show/NCT03335397.",2020,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","['undergraduate students enrolled in a health science first-degree program', 'A total of 99 students were enrolled, with 49 (49%) in the intervention group and 50 (51%) in the control group', 'Subjects who met the inclusion criteria', 'Undergraduate Students']","['intervention group (ie, blended learning involving traditional lectures plus m-learning via the use of the iPOT app) or the control group (ie, traditional on-site learning', 'Smartphone-based learning, or mobile learning (m-learning', 'blended learning method using traditional materials plus a mobile app-the iPOT mobile learning app']","['knowledge, motivation, mood state, and satisfaction', 'Motivation, Mood State, and Satisfaction', 'anger and hostility', 'motivation questionnaire', 'increased perception of greater gains in their English-language competence', 'theoretical knowledge gain', 'multiple-choice questions (ie, knowledge), the Instructional Materials Motivation Survey (ie, motivation), the Profile of Mood States scale (ie, mood state), and Likert-type questionnaires (ie, satisfaction and linguistic competence', 'motivation, mood state, and satisfaction']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}]",99.0,0.064006,"The intervention group subjects were more satisfied than the members of the control group with respect to five out of the six items evaluated: general satisfaction (P<.001), clarity of the instructions (P<.01), clarity with the use of the learning method (P<.001), enough time to complete the proposed exercises (P<.01), and improvement in the capacity to learn content (P<.001).","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Noguerol', 'Affiliation': 'Departamento de Lenguajes y Sistemas Informáticos e Ingeniería de Software, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Álvarez-Salvago', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Cruz-Fernández', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Journal of medical Internet research,['10.2196/17101']
1052,31385378,Sleep restriction does not potentiate nocebo-induced changes in pain and cortical potentials.,"BACKGROUND


The increased pain sensitivity following reduced sleep may be related to changes in cortical processing of nociceptive stimuli. Expectations shape pain perception and can inhibit (placebo) or enhance (nocebo) pain. Sleep restriction appears to enhance placebo responses; however, whether sleep restriction also affects nocebo responses remains unknown. The aim of the present study was to determine whether sleep restriction facilitates nocebo-induced changes in pain and pain-evoked cortical potentials.
METHODS


In an experimental study with a crossover design, the sensitivity to electrically induced pain was determined in 53 nurses under two sleep conditions, after habitual sleep and after two consecutive nights at work. Nocebo was induced by conditioning one-third of the pain stimuli. Pain-elicited cortical event-related potentials were recorded by electroencephalography (EEG). Data were analysed both in the time domain (N2P2 amplitude) and in the time-frequency domain (ERP magnitude). Sleepiness and vigilance were also assessed.
RESULTS


Both nocebo alone and sleep restriction alone increased the sensitivity to electrically induced pain. However, no interaction effect was found. Moreover, the magnitude of the pain-elicited responses increased after sleep restriction and decreased after nocebo expectation, suggesting that nocebo is probably not an underlying mechanism for the commonly observed hyperalgesia induced by sleep restriction.
CONCLUSIONS


The present work addresses whether sleep restriction, known to increase the sensitivity of the pain system, facilitates nocebo-induced hyperalgesia. Our findings suggest that this is not the case, indicating that the increased sensitivity of the pain system following nocebo and sleep restriction are mediated by different cortical mechanisms.",2020,"However, no interaction effect was found.","['53 nurses under two sleep conditions, after habitual sleep and after two consecutive nights at work']",['inhibit (placebo'],"['pain and pain-evoked cortical potentials', 'pain and cortical potentials', 'sensitivity to electrically induced pain', 'Sleepiness and vigilance']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",53.0,0.0684744,"However, no interaction effect was found.","[{'ForeName': 'Anbjørn', 'Initials': 'A', 'LastName': 'Ree', 'Affiliation': 'Department of Behavioral Sciences in Medicine, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kristian Bernhard', 'Initials': 'KB', 'LastName': 'Nilsen', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Knardahl', 'Affiliation': 'Department of Work Psychology and Physiology, National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Sand', 'Affiliation': 'Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Dagfinn', 'Initials': 'D', 'LastName': 'Matre', 'Affiliation': 'Department of Work Psychology and Physiology, National Institute of Occupational Health, Oslo, Norway.'}]","European journal of pain (London, England)",['10.1002/ejp.1466']
1053,32437174,"A transdiagnostic minority stress intervention for gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use: A randomized controlled trial.","OBJECTIVE


To remedy the notable gap in evidence-based treatments for sexual minority women, this study tested the efficacy of a minority-stress-focused cognitive-behavioral treatment intended to improve this population's mental and behavioral health.
METHOD


The intervention, EQuIP (Empowering Queer Identities in Psychotherapy), was adapted from a transdiagnostic cognitive-behavioral treatment as also recently adapted for sexual minority men. Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health. The resulting treatment was then delivered to young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use.
RESULTS


Compared to waitlist ( n  = 30), participants randomized to immediately receive EQuIP ( n  = 30) experienced significantly reduced depression and anxiety ( d  = 0.85, 0.86, respectively); effects for alcohol use problems were smaller ( d  = 0.29) and marginally significant. In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
CONCLUSIONS


This study provides initial support for a minority-stress-focused transdiagnostic cognitive-behavioral treatment for sexual minority women. These first results can launch exploration of other mechanisms and modalities through which to equip this population with evidence-based support. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","['sexual minority men', ""Sexual minority women at risk of mental and behavioral health problems ( n  = 19) and expert providers with this population ( n  = 12) shaped the treatment's development, including by supporting its primary focus on universal and minority-stress-focused processes underlying this population's disproportionately poor mental and behavioral health"", ""gender diverse sexual minority women's depression, anxiety, and unhealthy alcohol use"", 'sexual minority women', 'young adult sexual minority women ( n  = 60;  M  age = 25.58; 41.67% racial/ethnic minority; 43.33% transgender/nonbinary) experiencing depression/anxiety and past 90-day heavy alcohol use']","['transdiagnostic minority stress intervention', 'EQuIP']","['universal risk factors', 'depression and anxiety']","[{'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0292329,"In pre- to post-intervention pooled analyses, effect sizes for minority stress processes (mean  d  = .25) and universal risk factors (mean  d  = .48), through which the treatment was expected to work, were small and moderate, respectively, and in the expected direction.
","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pachankis', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'McConocha', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kirsty A', 'Initials': 'KA', 'LastName': 'Clark', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Behari', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Fetzner', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Cal D', 'Initials': 'CD', 'LastName': 'Brisbin', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Jillian R', 'Initials': 'JR', 'LastName': 'Scheer', 'Affiliation': 'Department of Social and Behavioral Sciences.'}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Lehavot', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value-Driven Care.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000508']
1054,30965064,"A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease.","PURPOSE


To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED).
DESIGN


A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial.
PARTICIPANTS


Adults (18-90 years of age) with a history and clinical diagnosis of DED, a global symptom score of 40 or more (range, 0-100), and a lissamine green conjunctival staining score of 3 or more and 9 or less (range, 0-12) in at least 1 eye.
METHODS


Eligible patients entered a run-in period of 14 to 20 days in which all patients administered vehicle twice daily. Patients who remained eligible at the baseline (day 0) visit were randomized in a 1:1 ratio to twice-daily treatment with OTX-101 0.09% or vehicle for 84 days.
MAIN OUTCOME MEASURES


Efficacy assessments included signs (unanesthetized Schirmer tear test, corneal and conjunctival staining) and symptoms (global symptom score) of DED. The primary end point was the proportion of eyes with a clinically meaningful improvement (increase of ≥10 mm) in Schirmer test score at day 84. Safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring, slit-lamp, dilated ophthalmoscopy, and fundus examinations.
RESULTS


A total of 744 patients were randomized and received study medication (371 to OTX-101 0.09% and 373 to vehicle). The primary end point was achieved; a significantly greater percentage of eyes in the OTX-101 0.09% treatment group achieved an increase of 10 mm or more in the Schirmer test score at day 84 (OTX-101 0.09%, 16.6%; vehicle, 9.2%; P < 0.001). Significant improvements relative to vehicle also were observed for corneal (days 28, 56, and 84) and conjunctival (days 56 and 84) staining. The global symptom score was reduced from baseline in both treatment groups by approximately 30%; however, no significant separation between groups was observed. The OTX-101 0.09% formulation was well tolerated. Treatment-emergent AEs were primarily mild in intensity.
CONCLUSIONS


Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.",2019,"CONCLUSIONS


Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.","['patients with dry eye disease (DED', '744 patients', 'Patients who remained eligible at the baseline (day 0) visit', 'Adults (18-90 years of age) with a history and clinical diagnosis of DED, a global symptom score of 40 or more (range, 0-100), and a lissamine green conjunctival staining score of 3 or more and 9 or less (range, 0-12) in at least 1 eye', 'Eligible patients entered a run-in period of 14 to 20 days in which all patients administered vehicle twice daily', 'Dry Eye Disease']","['OTX-101 0.09% or vehicle for 84 days', 'OTX-101 Ophthalmic Solution', 'OTX-101', 'cyclosporine']","['adverse events (AEs), visual acuity, and intraocular pressure monitoring, slit-lamp, dilated ophthalmoscopy, and fundus examinations', 'safety and efficacy', 'proportion of eyes with a clinically meaningful improvement', 'Schirmer test score', 'tolerated', 'percentage of eyes in the OTX-101', 'signs (unanesthetized Schirmer tear test, corneal and conjunctival staining) and symptoms (global symptom score) of DED', 'global symptom score', 'tear production and ocular surface integrity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C4517419', 'cui_str': 'Zero point zero nine'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0183355', 'cui_str': ""Gullstrand's Slit Lamp""}, {'cui': 'C0029090', 'cui_str': 'Ophthalmoscopy'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2363241', 'cui_str': 'Tear production, function (observable entity)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}]",744.0,0.353489,"CONCLUSIONS


Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.","[{'ForeName': 'Damien F', 'Initials': 'DF', 'LastName': 'Goldberg', 'Affiliation': 'Wolstan & Goldberg Eye Associates, Torrance, California. Electronic address: goldbed@hotmail.com.'}, {'ForeName': 'Ranjan P', 'Initials': 'RP', 'LastName': 'Malhotra', 'Affiliation': 'Ophthalmology Associates, Cornea and LaserVision Institute, St. Louis, Missouri.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Schechter', 'Affiliation': 'Florida Eye Microsurgical Institute, Boynton Beach, Florida.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Justice', 'Affiliation': 'Sun Pharmaceutical Industries, Ltd., Princeton, New Jersey.'}, {'ForeName': 'Sidney L', 'Initials': 'SL', 'LastName': 'Weiss', 'Affiliation': 'i-Novion, Inc., Randolph, New Jersey.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sheppard', 'Affiliation': 'Virginia Eye Consultants and Eastern Virginia Medical School, Norfolk, Virginia.'}]",Ophthalmology,['10.1016/j.ophtha.2019.03.050']
1055,32243253,Effect of Deep Margin Elevation on CAD/CAM-Fabricated Ceramic Inlays.,"CLINICAL RELEVANCE


Using the deep margin elevation technique in preparations extending beyond the cemento-enamel junction appears to be beneficial in maintaining structural integrity of CAD/CAM-fabricated feldspathic ceramic inlays.
SUMMARY


Objective: To evaluate the effect of deep margin elevation on structural and marginal integrity of ceramic inlays.Methods and Materials: Forty extracted human third molars were collected and randomly separated into four groups (n=10/group). In group 1 (enamel margin group), the gingival margin was placed 1 mm supragingival to the cemento-enamel junction (CEJ). In group 2 (cementum margin group), the gingival margin was placed 2 mm below the CEJ. In group 3 (glass ionomer [GI] margin group), the gingival margin was placed 2 mm below the CEJ, and then the margin elevated with GI to the CEJ. In group 4 (resin-modified glass ionomer [RMGI] margin group), the gingival margin was placed 2 mm below the CEJ, and then the margin elevated with RMGI to the CEJ. Standardized ceramic class II inlays were fabricated with computer-aided design/computer-aided manufacturing and bonded to all teeth, and ceramic proximal box heights were measured. All teeth were subjected to 10,000 cycles of thermocycling (5°C/55°C) and then underwent 1,200,000 cycles of vertical chewing simulation at 50 N of force. Ceramic restorations and marginal integrity were assessed with a Hirox digital microscope. The Fisher exact test (two-tailed) with adjusted p-values (α=0.05) and logistic regression were used for statistical analysis.Results: The cementum margin group had a significantly higher ceramic fracture rate (90%) compared to other groups (10% in enamel margin and GI margin groups, p=0.007; 0% in RMGI group, p<0.001). Logistic regression showed that with increased ceramic proximal box heights, the probability of ceramic fracture increased dramatically.Conclusion: Deep marginal elevation resulted in decreased ceramic fracture when preparation margins were located below the CEJ. There was no difference found between margin elevation with GI or RMGI. Increased heights of ceramic proximal box may lead to an increased probability of ceramic fracture.",2020,"The cementum margin group had a significantly higher ceramic fracture rate (90%) compared to other groups (10% in enamel margin and GI margin groups,  p =0.007; 0% in RMGI group,  p <0.001).",['Forty extracted human third molars'],['gingival margin was placed 1 mm supragingival to the cemento-enamel junction (CEJ'],"['ceramic proximal box heights, the probability of ceramic fracture', 'ceramic fracture rate', 'probability of ceramic fracture', 'ceramic fracture', 'margin elevation with GI or RMGI']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0227011', 'cui_str': 'Structure of cementoenamel junction'}]","[{'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.0197905,"The cementum margin group had a significantly higher ceramic fracture rate (90%) compared to other groups (10% in enamel margin and GI margin groups,  p =0.007; 0% in RMGI group,  p <0.001).","[{'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Vertolli', 'Affiliation': ''}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Martinsen', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Hanson', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kooistra', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ''}]",Operative dentistry,['10.2341/18-315-L']
1056,31937856,Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,"Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. The primary outcome variables were fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia. In Intention-to-treat analysis, at the end of intervention, we observed significant decrease in FBG [-5.0 (-12.6-2.4), p = 0.04], 2-h blood glucose post OGTT [-11(-49.3-26.9), p = 0.02], hemoglobin A1c [-0.41 (5.89, 6.55), p = 0.05] and increase in 25(OH) D [7.5 (-6.0-20.9), p = 0.002] levels in intervention as compared to the placebo group. Changes in glycemic category based on FBG were as follows; intervention group: normal FBG, 58.6%; impaired fasting glucose (IFG), 39%; and type 2 diabetes mellitus (T2DM), 2.4%; placebo group: normal FBG, 48.8%; IFG, 46.3%; and T2DM, 4.9%. Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit I st  compared to visit III rd ) and suprailiac skinfold (visit II nd  compared to visit III rd ) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.",2020,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","['prediabetic and vitamin D deficient overweight/obese Asian Indian women', 'Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat', '121 females (aged 20-60 years) with prediabetes and vitamin D deficiency']","['Placebo', 'Vitamin D deficiency', 'vitamin D supplementation', 'Vitamin D Supplementation', 'placebo']","['FBG', 'fasting glucose (IFG', 'subscapular skinfold (visit I st  compared to visit III rd ) and suprailiac skinfold', 'normal glucose tolerance', 'hemoglobin A1c', 'glycemic category based on\xa0FBG', 'FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia', 'glycemic profile and body composition', 'fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia', '25(OH']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0943356,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-019-56904-y']
1057,32241605,Results of the PARAMEDIC-2 trial and how they relate to resuscitation after cardiac surgery.,,2020,,[],[],[],[],[],[],,0.0198411,,"[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Dunning', 'Affiliation': 'Department of Thoracic Surgery, James Cook University Hospital, Middlesbrough, United Kingdom. Electronic address: Joeldunning@doctors.org.uk.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Trevis', 'Affiliation': 'Department of Thoracic Surgery, James Cook University Hospital, Middlesbrough, United Kingdom.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.02.050']
1058,32494942,Microenterprise Intervention to Reduce Sexual Risk Behaviors and Increase Employment and HIV Preventive Practices Among Economically-Vulnerable African-American Young Adults (EMERGE): A Feasibility Randomized Clinical Trial.,"Economic vulnerability, such as homelessness and unemployment, contributes to HIV risk among U.S. racial minorities. Yet, few economic-strengthening interventions have been adapted for HIV prevention in this population. This study assessed the feasibility of conducting a randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors. The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Primary feasibility objectives assessed recruitment, randomization, participation, and retention. Secondary objectives examined employment, sexual risk behaviors, and HIV preventive behaviors. Outcome assessments used an in-person pre- and post-intervention interview and a weekly text message survey. Several progression criteria for a definitive trial were met. Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19) of which 95% were retained. The comparison intervention enhanced willingness to be randomized and reduced non-participation. Mean age of participants was 21.0 years; 35% were male; 81% were unemployed. Fifty-eight percent (58%) of experimental participants completed ≥ 70% of intervention activities, and 74% completed ≥ 50% of intervention activities. Participation in intervention activities and outcome assessments was highest in the first half (~ 10 weeks) of the study. Seventy-one percent (71%) of weekly text message surveys received a response through week 14, but responsiveness declined to 37% of participants responding to ≥ 70% of weekly text message surveys at the end of the study. The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group. Conducting this feasibility trial was a critical step in the process of designing and testing a behavioral intervention. Development of a fully-powered effectiveness trial should take into account lessons learned regarding intervention duration, screening, and measurement.Trial Registration ClinicalTrials.gov. NCT03766165. Registered 04 December 2018. https://clinicaltrials.gov/ct2/show/NCT03766165.",2020,The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group.,"['Mean age of participants was 21.0\xa0years; 35% were male; 81% were unemployed', 'economically-vulnerable African-American young adults', 'Economically-Vulnerable African-American Young Adults (EMERGE', 'Thirty-eight participants']","['text messages on job openings only', 'Microenterprise Intervention', 'text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages', 'microenterprise intervention']","['higher employment', 'Sexual Risk Behaviors', 'employment, sexual risk behaviors, and HIV preventive behaviors', 'recruitment, randomization, participation, and retention', 'sexual risk behaviors', 'person pre- and post-intervention interview and a weekly text message survey']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",38.0,0.0844624,The experimental group reported higher employment (from 32% at baseline to 83% at week 26) and lower unprotected sex (79% to 58%) over time compared to reported changes in employment (37% to 47%) and unprotected sex (63% to 53%) over time in the comparison group.,"[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Indiana University School of Public Health, Department of Applied Health Science, 1025 E. 7th Street, Bloomington, IN, USA. ljmayowi@iu.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Fatmata', 'Initials': 'F', 'LastName': 'Timbo', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'The Brown School, Washington University in St. Louis, Goldfarb, One Brookings, Drive, St. Louis, MO, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA, USA.'}, {'ForeName': 'Grace T', 'Initials': 'GT', 'LastName': 'Yi', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Bee-Ah', 'Initials': 'BA', 'LastName': 'Kang', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences, 5510 Nathan Shock Drive, Baltimore, MD, USA.'}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Biostatistics, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dodge', 'Affiliation': 'Johns Hopkins University School of Public Health, Department of International Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, 525 N. Wolfe Street, Baltimore, MD, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02931-0']
1059,32496921,Neurocognitive effects of atypical antipsychotics in patients with first-episode schizophrenia.,"Introduction:  Cognitive impairment is a core feature of schizophrenia. The effects of atypical antipsychotics on the cognitive functions of patients with first-episode schizophrenia have not been comprehensively investigated so far. This study aims to compare neurocognitive effects of risperidone, olanzapine, and aripiprazole for first-episode schizophrenia. Methods:  The study was a multicenter, randomized, open-label clinical trial. 546 patients were randomly divided into three medication groups, and followed up for 1 year. Cognitive performance was evaluated with a neuropsychological test battery. The Clinical trials.gov ID of the study is NCT01057849. Results:  At 6 months, treatment resulted in significant improvements in all three groups in most cognitive domains except verbal learning and memory. At 12 months, three treatment groups had further improvements in three cognitive domains, but visual learning and memory performance dropped back to baseline. Conclusion:  All three atypical antipsychotics tested in the study can potentially improve cognitive performance in first-episode schizophrenia, but no significant difference in the degree of improvement was found between drugs.",2020,"At 12 months, three treatment groups had further improvements in three cognitive domains, but visual learning and memory performance dropped back to baseline.","['first-episode schizophrenia', 'patients with first-episode schizophrenia', '546 patients']","['atypical antipsychotics', 'risperidone, olanzapine, and aripiprazole']","['cognitive domains except verbal learning and memory', 'cognitive performance', 'three cognitive domains, but visual learning and memory performance', 'Neurocognitive effects', 'Cognitive performance']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",546.0,0.0209529,"At 12 months, three treatment groups had further improvements in three cognitive domains, but visual learning and memory performance dropped back to baseline.","[{'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Jiaheng', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Peking University, Beijing, 100191, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Shi', 'Affiliation': 'Peking University Sixth Hospital, Beijing, 100191, China.'}]",Nordic journal of psychiatry,['10.1080/08039488.2020.1771767']
1060,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND


Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities.
RESEARCH QUESTION


Is underwater gait training or overground gait training more effective in severe stroke patients?
METHODS


A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training.
RESULTS


Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm).
SIGNIFICANCE


In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking.
CLINICAL TRIAL REGISTRATION NUMBER


KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022']
1061,32508339,Robot-assisted gait training promotes brain reorganization after stroke: A randomized controlled pilot study.,"BACKGROUND


Robot-assisted gait training (RAGT) can improve walking ability after stroke but the underlying mechanisms are unknown.
OBJECTIVE


We evaluated the changes in the injured brain after RAGT and compared the effects of early start and late start of RAGT.
METHODS


Eleven patients with hemiplegia after stroke undergoing inpatient rehabilitation were examined within 3 months of stroke onset and were randomly assigned into two groups. Group 1 started RAGT with conventional physiotherapy immediately after enrollment, whereas Group 2 underwent conventional physiotherapy for 4 weeks before starting RAGT. We acquired diffusion tensor imaging data after enrollment and at 4 and 8 weeks after treatment. Fractional anisotropy (FA) and mean diffusivity (MD) maps were used to analyze the neural changes.
RESULTS


Repeated measures analysis of variance of the data at 4 weeks after treatment showed a significant interaction between time and groups (RAGT versus control) for the FA and MD values in the non-lesioned hemisphere, indicating that the non-lesioned hemisphere was significantly reorganized by RAGT compared with conventional physiotherapy. Analysis of the data at 8 weeks after treatment showed a significant interaction between time and groups (early and late start of RAGT) for the MD values in the motor-related areas bilaterally, indicating that early start of RAGT significantly accelerated bi-hemispheric reorganization as compared with late start of RAGT.
CONCLUSIONS


Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri. Furthermore, early start of RAGT can accelerate bi-hemispheric reorganization in the motor-related brain regions.",2020,"Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri.",['Eleven patients with hemiplegia after stroke undergoing inpatient rehabilitation were examined within 3 months of stroke onset'],"['conventional physiotherapy', 'Robot-assisted gait training (RAGT', 'Robot-assisted gait training', 'RAGT']",['Fractional anisotropy (FA) and mean diffusivity (MD) maps'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",11.0,0.0447341,"Our findings indicate that RAGT can facilitate reorganization in the intact superior temporal, cingulate, and postcentral gyri.","[{'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Chang Soon', 'Initials': 'CS', 'LastName': 'Kang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Kyeong', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Veterans Health Service Medical Center, Seoul, South Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203054']
1062,32508341,"Combined effects of backward treadmill training and botulinum toxin type A therapy on gait and balance in patients with chronic stroke: A pilot, single-blind, randomized controlled trial.","BACKGROUND


Backward walking is recommended to improve the components of physiological gait in neurological disease. Botulinum toxin type A is an effective safe first line-treatment for post-stroke spasticity.
OBJECTIVE


To compare the effects of backward treadmill training (BTT) versus standard forward treadmill training (FTT) on motor impairment in patients with chronic stroke receiving botulinum toxin type A therapy.
METHODS


Eighteen chronic stroke patients were randomly assigned to receive BTT (n = 7) or FTT (n = 11) as adjunct to botulinum toxin type A therapy. A total of twelve 40-minute sessions (3 sessions/week for 4 weeks) of either BTT or FTT were conducted. A blinded assessor evaluated the patients before and after treatment. The primary outcome was the 10-meter Walking Test (10 MWT). Secondary outcomes were the modified Ashworth Scale, gait analysis, and stabilometric assessment.
RESULTS


Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment.
CONCLUSIONS


Greater improvement in gait and balance was noted after BTT than after FTT as an adjunct to botulinum toxin therapy in patients with chronic stroke.",2020,"RESULTS


Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment.
","['patients with chronic stroke receiving botulinum toxin type A therapy', 'Eighteen chronic stroke patients', 'patients with chronic stroke']","['BTT or FTT', 'BTT', 'backward treadmill training (BTT) versus standard forward treadmill training (FTT', 'backward treadmill training and botulinum toxin type', 'botulinum toxin type A therapy', 'Botulinum toxin type A', 'FTT', 'botulinum toxin therapy']","['length of CoP', 'stabilometric assessment [length of centre of pressure CoP', 'modified Ashworth Scale, gait analysis, and stabilometric assessment', '10\u200aMWT', '10-meter Walking Test (10\u200aMWT', 'gait and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.0763676,"RESULTS


Between-group comparison showed a significant change on the 10 MWT (P = 0.008) and on stabilometric assessment [length of centre of pressure CoP (P = 0.001) and sway area (P = 0.002) eyes open and length of CoP (P = 0.021) and sway area (P = 0.008) eyes closed] after treatment.
","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Serina', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Disarò', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Department of Neurosciences, Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203067']
1063,32517389,"Intermediate Cervical Plexus Block in the Management of Persistent Postoperative Pain Post Carotid Endarterectomy: A Prospective, Randomized, Controlled, Clinical Trial.","BACKGROUND


The mechanisms of persistent postoperative pain (PPP) with neuropathic features after carotid endarterectomy (CEA) are multifaceted and are incompletely understood.
OBJECTIVES


The aim of this research was to assess whether the ultrasound-guided (USG) intermediate cervical plexus block (ICPB) could provide better control of PPP and neuropathic disturbances (NPDs) after CEA than the USG superficial cervical plexus block (SCPB).
STUDY DESIGN


Prospective, randomized, controlled, clinical trial.
SETTING


This clinical trial was conducted at the SS Filippo and Nicola Academic Hospital of Avezzano (L'Aquila, Italy).
METHODS


Patients who were scheduled for primary CEA were chosen. In the experimental group, the USG-ICPB was performed unilaterally, at the level of the third cervical vertebra. The needle was inserted into the deep lamina of the deep fascia of the neck, between the posterior border of the middle scalene muscle and the anterior border of the posterior scalene muscle. Three milliliters saline solution was injected into the opening of the deep lamina, and 20 mL 0.375% levobupivacaine was injected. In the control group, the anesthetic target was located at the inferior border of the sternocleidomastoid muscle at the level of the third cervical vertebra. The needle was superficially inserted below the skin, and 2 to 3 mL saline solution was injected into the opening of the superficial lamina of the deep fascia of the neck. A total of 20 mL 0.375% isobaric levobupivacaine was subsequently injected.The primary outcome measure was the proportion of patients with PPP on movement and at rest 3 months after surgery. The secondary outcome measures were NPD assessment scores using the von Frey hair test and the Lindblom test, opioid and pregabalin consumption. Adverse effects were also recorded.
RESULTS


A total of 98 consecutive patients were enrolled and randomized to receive either a USG-SCPB (control group, n = 49) or a USG-ICPB (experimental group, n = 49). The sensory blockade was longer in the experimental group. Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063). The proportions of patients with NPDs were not different between the groups, whereas the sizes of the areas of interest (cm2) were significantly different.
LIMITATIONS


A limitation of this study is that we assessed NPDs for only 3 months using the von Frey hair test and the Lindblom test without additional instrumental techniques. Additionally, there are many risk factors for NPDs after CEA. For this reason, another limitation of this research is that we neglected to consider the relationship between the choice of anesthetic block and the presence of these risk factors.
CONCLUSIONS


The USG-ICPB provided long-lasting analgesia during the postoperative period and might mitigate the development of NPDs, thereby decreasing the analgesic drug requirement.
KEY WORDS


Carotid endarterectomy, intermediate cervical plexus block, myofascial planes of neck, neuropathic disturbances, persistent postoperative pain, superficial cervical plexus blocks, ultrasound guidance, vascular disease.",2020,"Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063).","['98 consecutive patients', 'Patients who were scheduled for primary CEA were chosen', ""SS Filippo and Nicola Academic Hospital of Avezzano (L'Aquila, Italy""]","['Intermediate Cervical Plexus Block', 'carotid endarterectomy (CEA', 'levobupivacaine', 'ultrasound-guided (USG) intermediate cervical plexus block (ICPB', 'isobaric levobupivacaine', 'USG-SCPB (control group, n = 49) or a USG-ICPB']","['proportions of patients with pain', 'proportion of patients with PPP on movement', 'NPD assessment scores using the von Frey hair test and the Lindblom test, opioid and pregabalin consumption', 'Adverse effects', 'sensory blockade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0394689', 'cui_str': 'Injection of anesthetic agent into cervical plexus'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0068515', 'cui_str': 'neodymium pyrocatechin disulfonate'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]",98.0,0.0787637,"Three months after surgery, the proportions of patients with PPP on movement were significantly different between the experimental and control groups (33%, 95% confidence intervals [CI], 20%-47% vs. 71%, 95% CI, 57%-83%; P < 0.001), whereas there were no differences in the proportions of patients with pain at rest between groups (31%, 95% CI, 18%-45% vs. 49%, 95% CI, 34%-64%; P = 0.063).","[{'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Petrucci', 'Affiliation': ""Department of Anesthesia and Intensive Care Unit, San Salvatore Academic Hospital of L'Aquila, Italy.""}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Cofini', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pizzi', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Coletta', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Angelo Geremia', 'Initials': 'AG', 'LastName': 'Blasetti', 'Affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano, Avezzano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Necozione', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Fusco', 'Affiliation': ""Department of Anesthesia and Intensive Care Unit, San Salvatore Academic Hospital of L'Aquila, Italy.""}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Marinangeli', 'Affiliation': ""Department of life health & environmental sciences, University of L'Aquila.""}]",Pain physician,[]
1064,32521538,"Colon-delivered short-chain fatty acids attenuate the cortisol response to psychosocial stress in healthy men: a randomized, placebo-controlled trial.","Short-chain fatty acids (SCFAs) are products of microbial fermentation of dietary fiber in the colon and may mediate microbiota-gut-brain communication. However, their role in modulating psychobiological processes that underlie the development of stress- and anxiety-related disorders is not mechanistically studied in humans. In this triple-blind, randomized, placebo-controlled intervention trial, we examine in a parallel group design the effects of 1-week colonic SCFA-mixture delivery in doses equivalent to fermentation of 10 g or 20 g of arabinoxylan oligosaccharides on responses to psychosocial stress and fear tasks in 66 healthy men. We demonstrate that low and high doses of SCFAs significantly attenuate the cortisol response to psychosocial stress compared to placebo. Both doses of SCFAs increase serum SCFA levels and this increase in circulating SCFAs co-varies significantly with the attenuation of the cortisol response to psychosocial stress. Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings. These results demonstrate that colon-delivered SCFAs modulate hypothalamic-pituitary-adrenal axis reactivity to psychosocial stress, thereby supporting their hypothesized role in microbiota-gut-brain communication.",2020,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","['healthy men', '66 healthy men']","['Short-chain fatty acids (SCFAs', 'colonic SCFA-mixture delivery', 'SCFAs', 'Colon-delivered short-chain fatty acids', 'arabinoxylan oligosaccharides', 'placebo']","['fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings', 'cortisol response to psychosocial stress', 'serum SCFA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.031091,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","[{'ForeName': 'Boushra', 'Initials': 'B', 'LastName': 'Dalile', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Laboratory of Biological Psychology, Brain & Cognition, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bergonzelli', 'Affiliation': 'Department of Gastrointestinal Health, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Verbeke', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium. lukas.vanoudenhove@kuleuven.be.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0732-x']
1065,32521561,Factors Associated with Formula Feeding among Late Preterm Neonates.,"OBJECTIVE


Late preterm births (delivery at 34-36 weeks) account for nearly three quarters of the preterm births and among them there is a knowledge gap about an important aspect of infant care: breast versus formula feeding. The aim of this study was to assess factors associated with formula feeding in late preterm neonates.
STUDY DESIGN


Secondary analysis of a multicenter randomized trial of antenatal corticosteroids for women at risk for late preterm birth. All women with a singleton pregnancy who delivered at 34 0/7  to 36 6/7  weeks were included. Women with no information on neonatal feeding or known fetal anomalies were excluded. The outcome evaluated was the type of neonatal feeding during hospital stay. Maternal and neonatal characteristics were compared among women who initiated breast versus formula feeding. Adjusted relative risks (aRRs) for formula feeding with 95% confidence intervals (CIs) were calculated.
RESULTS


Of the 2,831 women in the parent trial, 2,329 (82%) women met inclusion criteria and among them, 696 (30%) were formula feeding. After multivariable regression, the following characteristics were associated with an increased risk of formula feeding: maternal age < 20 years (aRR: 1.47, 95% CI: 1.20-1.80) or ≥35 years (aRR: 1.19, 95% CI: 1.02-1.40), never married status (aRR: 1.39, 95% CI: 1.20-1.60), government-assisted insurance (aRR: 1.41, 95% CI: 1.16-1.70), chronic hypertension (aRR: 1.19, 95% CI: 1.01-1.40), smoking (aRR: 1.51, 95% CI: 1.31-1.74), cesarean delivery (aRR: 1.16, 95% CI: 1.03-1.32), and admission to neonatal intensive care unit (aRR: 1.31, 95% CI: 1.16-1.48). Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding.
CONCLUSION


In this geographically diverse cohort of high-risk deliveries, 3 out 10 late preterm newborns were formula fed. Smoking cessation was a modifiable risk factor that may diminish the rate of formula feeding among late preterm births.
KEY POINTS


· Three of ten late preterm do not benefit from breastfeeding.. · Demographic characteristics are associated with type of feeding.. · Smoking cessation may improve the rate of breastfeeding..",2020,"Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding.
","['Late Preterm Neonates', 'late preterm neonates', 'Women with no information on neonatal feeding or known fetal anomalies', '2,831 women in the parent trial, 2,329 (82', 'All women with a singleton pregnancy who delivered at 34 0/7  to 36 6/7  weeks were included', 'women met inclusion criteria and among them, 696 (30%) were formula feeding', 'aRR', 'women at risk for late preterm birth']","['aRR', 'antenatal corticosteroids']","['chronic hypertension', 'cesarean delivery', 'risk of formula feeding: maternal age\u2009<\u200920 years (aRR', 'Hispanic ethnicity', 'rate of breastfeeding', 'type of neonatal feeding during hospital stay', 'Maternal and neonatal characteristics', 'government-assisted insurance ']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]",2831.0,0.239817,"Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding.
","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Fishel Bartal', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Han-Yang', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston (UT Health), Houston, Texas.'}]",American journal of perinatology,['10.1055/s-0040-1712952']
1066,32530368,Mnemonic discrimination and social anxiety: the role of state anxiety.,"The Mnemonic Similarity Task (MST) measures mnemonic discrimination, or the ability to correctly identify new stimuli from highly similar, old stimuli. Poor mnemonic discrimination is a potential risk or maintenance factor for anxiety, and recent studies suggest state affect may moderate relations between mnemonic discrimination and trait anxiety. No studies have evaluated mnemonic discrimination in specific subtypes of anxiety or with clinically relevant stressors. This preregistered study evaluated the role of social anxiety and the anticipation of a future speech on MST performance. Participants with high ( n  = 66) and low ( n  = 64) levels of social anxiety were randomly assigned to a stressor condition or a control condition prior to the MST. State anxiety was measured throughout the study. Results did not indicate significant effects of trait (high vs. low social anxiety) or state anxiety (stressor condition vs. control condition) on mnemonic discrimination. Results are compared with previous research and implications and future directions are discussed.",2020,Results did not indicate significant effects of trait (high vs. low social anxiety) or state anxiety (stressor condition vs. control condition) on mnemonic discrimination.,['Participants with high ( n \u2009=\u200966) and low ( n \u2009=\u200964) levels of social anxiety'],['stressor condition or a control condition prior to the MST'],"['State anxiety', 'Mnemonic discrimination and social anxiety']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]",,0.0105994,Results did not indicate significant effects of trait (high vs. low social anxiety) or state anxiety (stressor condition vs. control condition) on mnemonic discrimination.,"[{'ForeName': 'Gabriella T', 'Initials': 'GT', 'LastName': 'Ponzini', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, USA.'}, {'ForeName': 'Shari A', 'Initials': 'SA', 'LastName': 'Steinman', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, USA.'}]",Cognition & emotion,['10.1080/02699931.2020.1779039']
1067,32682992,Characterizing the analgesic effects of real and imagined acupuncture using functional and structure MRI.,"Acupuncture and imagery interventions for pain management have a long history. The present study comparatively investigated whether acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture on the participant's own body while imagining it being applied) could modulate brain regional connectivity to produce analgesic effects. The study also examined whether pre-intervention brain functional and structural features could be used to predict the magnitude of analgesic effects. Twenty-four healthy participants were recruited and received four different interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control) in random order using a cross-over design. Pain thresholds and magnetic resonance imaging (MRI) data were collected before and after each intervention. We first compared the modulatory effects of real acupuncture and VGAIT on intra- and inter-regional intrinsic brain connectivity and found that real acupuncture decreased regional homogeneity (ReHo) and functional connectivity (FC) in sensorimotor areas, whereas VGAIT increased ReHo in basal ganglia (BG) (i.e., putamen) and FC between the BG subcortical network and default mode network. The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively. A multimodality fusion approach with pre-intervention ReHo and gray matter volume (GMV) as features was used to explore the brain profiles underlying individual variability of pain threshold changes by real acupuncture and VGAIT. Variability in acupuncture responses was associated with ReHo and GMV in BG, whereas VGAIT responses were associated with ReHo and GMV in the anterior insula. These results suggest that, through different pathways, both real acupuncture and VGAIT can modulate brain systems to produce analgesic effects.",2020,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.",['Twenty-four healthy participants'],"['real acupuncture and VGAIT', 'acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture', 'pre-intervention ReHo and grey matter volume (GMV', 'interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control', 'Acupuncture and imagery interventions']","['pain threshold', 'Pain thresholds and magnetic resonance imaging (MRI) data', 'regional homogeneity (ReHo) and functional connectivity (FC']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",24.0,0.0799386,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States; Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States. Electronic address: jkong2@mgh.harvard.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117176']
1068,32506975,Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease.,"INTRODUCTION


Interstitial lung disease (ILD) is a leading cause of death in patients with systemic sclerosis (SSc). Nonspecific immunosuppressants have been the first-line treatment for SSc-associated ILD (SSc-ILD). Nintedanib, an oral triple kinase inhibitor targeting profibrotic pathways, has been employed for the treatment of idiopathic pulmonary fibrosis and has recently received marketing approval in the United States and Japan, based on the results of a placebo-controlled randomized controlled trial. In this clinical trial, nintedanib delayed the progression of SSc-ILD compared with placebo.
AREAS COVERED


This review covers current pharmacotherapies for SSc-ILD, drug profiles of nintedanib, and efficacy and safety profiles of nintedanib in patients with idiopathic pulmonary fibrosis and SSc-ILD observed in randomized controlled trails.
EXPERT OPINION


Currently, we have two treatment options for SSc-ILD, i.e., immunosuppressants and antifibrotic agents. However, appropriate utilization of antifibrotic agents in clinical practice remains challenging, i.e., in which cases they are to be used, timing of use, how to use them properly, and whether in combination with immunosuppressants.",2020,"In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo.
","['systemic sclerosis-associated interstitial lung disease', 'patients with systemic sclerosis (SSc', 'patients with idiopathic pulmonary fibrosis and SSc-ILD']","['Nintedanib', 'placebo']",[],"[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0547629,"In this clinical trial, Nintedanib delayed the progression of SSc-ILD compared with placebo.
","[{'ForeName': 'Yoshioki', 'Initials': 'Y', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School , Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Department of Allergy and Rheumatology, Nippon Medical School , Tokyo, Japan.'}]",Expert review of clinical immunology,['10.1080/1744666X.2020.1777857']
1069,32513495,Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture.,"PURPOSE


Current treatment guidelines recommend treatment for postmenopausal women with a T score <2.5 regardless of age. This subgroup analysis evaluated the efficacy and safety of abaloparatide in younger postmenopausal women considered to be at high risk for fracture.
METHODS


Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization).
FINDINGS


A total of 296 women (age range, 49-64 years) were included. Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites). Fracture rates were numerically lower for abaloparatide versus placebo, consistent with the overall trial results, although the differences were not statistically significant. The number needed to treat to prevent 1 additional vertebral fracture after 18 months of treatment versus placebo was 18 for abaloparatide and 21 for teriparatide. The number needed to treat had nonsignificant trends toward lower values with abaloparatide versus teriparatide for nonvertebral fractures (23 vs 40) and clinical fractures (16 vs 73) and similar for major osteoporotic fractures (24 vs 27). The safety profile was consistent with the overall ACTIVE population.
IMPLICATIONS


Findings of this subgroup (post hoc) analysis are consistent with the overall ACTIVE population. Abaloparatide appears to be effective and well tolerated in this subgroup of younger postmenopausal women. ClinicalTrials.gov identifier: NCT01343004.",2020,"Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites).","['Women with Osteoporosis at High Risk for Fracture', 'postmenopausal women with a T score <2.5 regardless of age', 'Younger Postmenopausal', 'younger postmenopausal women', 'Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization', '296 women (age range, 49-64 years) were included']","['placebo', 'teriparatide', 'abaloparatide versus teriparatide', 'Abaloparatide']","['bone mineral density', 'Fracture rates', 'clinical fractures', 'number needed to treat to prevent 1 additional vertebral fracture', 'Bone Mineral Density and Fracture Incidence', 'major osteoporotic fractures', 'efficacy and safety of abaloparatide', 'nonvertebral fractures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}]",296.0,0.32921,"Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites).","[{'ForeName': 'Kenneth G', 'Initials': 'KG', 'LastName': 'Saag', 'Affiliation': 'Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Setareh A', 'Initials': 'SA', 'LastName': 'Williams', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Weiss', 'Affiliation': 'Radius Health Inc, Waltham, MA, USA. Electronic address: rweiss@radiuspharm.com.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.04.012']
1070,32515065,The effect of diaphragm fatigue on the multidimensional components of dyspnoea and diaphragm electromyography during exercise in healthy males.,"KEY POINTS


Diaphragm fatigue may increase the intensity (sensory dimension) and unpleasantness (affective dimension) of dyspnoea, which may partially explain why diaphragm fatigue negatively affects exercise performance. We hypothesized that diaphragm fatigue would negatively affect exercise performance via increases in both the intensity and unpleasantness of dyspnoea, and that the increase in dyspnoea would be mechanistically linked to an increase in diaphragmatic EMG (EMG di  ), a surrogate measure of neural respiratory drive. Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea. The change in submaximal dyspnoea unpleasantness was significantly correlated with the change in cycling performance. Pre-fatigue of the diaphragm did not increase EMG di  during exercise and is therefore unrelated to the increase in either the sensory or affective dimension of exertional dyspnoea.
ABSTRACT


The purpose of this study was to examine the effect of diaphragm fatigue on the multidimensional components of dyspnoea and diaphragm electromyography (EMG di  ) during cycling. Sixteen healthy males (age = 27 ± 5 yr,    V   ̇   O   2   max         = 45.8 ± 9.8 ml kg -1   min -1  ) completed two high-intensity, time-to-exhaustion cycling tests in randomized order: (i) inspiratory pressure threshold loading (PTL) prior to exercise to induce diaphragm fatigue (pre-DF) and (ii) no PTL (control). Diaphragm fatigue after PTL was confirmed via cervical magnetic stimulation of the phrenic nerves. Dyspnoea intensity and unpleasantness were measured throughout exercise with the 0-10 category-ratio Borg scale and following exercise using the Multidimensional Dyspnoea Profile (MDP). EMG di  was continuously recorded via a multipair oesophageal electrode catheter. Time-to-exhaustion decreased with pre-DF vs. control (9.0 ± 5.5 vs. 10.7 ± 7.5 min, P = 0.023). Pre-DF increased dyspnoea intensity ratings by 0.6 ± 1.0 Borg 0-10 units at the highest equivalent submaximal exercise time (HESET) a participant could achieve in both conditions (P = 0.020). Dyspnoea unpleasantness ratings increased with pre-DF by 0.5 ± 1.0, 0.7 ± 1.2 and 0.9 ± 1.4 (all P < 0.05) Borg 0-10 units during the 2nd, 3rd and 4th minutes of exercise, respectively. There was a significant correlation between the change in breathing unpleasantness ratings at HESET and the change in time-to-exhaustion (r = 0.66, P = 0.006). The immediate perception domain, a combination of peak unpleasantness and specific dyspnoea descriptor intensity ratings, was the only component of the MDP that was significantly increased with pre-DF (4.3 ± 1.9 vs. 3.6 ± 1.8, P = 0.04). There were no significant differences in EMG di  . In conclusion, diaphragm fatigue has negative effects on multiple domains of dyspnoea, which may partially explain why exercise performance decreases with it.",2020,Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea.,"['healthy males', 'Sixteen healthy males (age\xa0=\xa027\xa0±']",['i) inspiratory pressure threshold loading (PTL) prior to exercise'],"['diaphragmatic EMG (EMG di  ', 'intensity (sensory dimension) and unpleasantness (affective dimension) of dyspnoea', 'dyspnoea and diaphragm electromyography (EMG di  ', 'submaximal dyspnoea unpleasantness', 'Diaphragm fatigue', 'Dyspnoea intensity and unpleasantness', 'Dyspnoea unpleasantness ratings', 'breathing unpleasantness ratings', 'Time-to-exhaustion', 'time-to-exhaustion', 'diaphragm fatigue (pre-DF) and (ii', 'peak unpleasantness and specific dyspnoea descriptor intensity ratings', 'intensity and unpleasantness of dyspnoea', 'dyspnoea intensity ratings']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282354', 'cui_str': 'Descriptor'}]",16.0,0.0454686,Fatiguing the diaphragm prior to exercise reduced cycling performance and increased both the intensity and unpleasantness of dyspnoea.,"[{'ForeName': 'Kyle G', 'Initials': 'KG', 'LastName': 'Boyle', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Reid A', 'Initials': 'RA', 'LastName': 'Mitchell', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Schaeffer', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': ""Centre for Heart and Lung Innovation, St. Paul's Hospital, Vancouver, Canada.""}]",The Journal of physiology,['10.1113/JP279755']
1071,32516486,A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension.,"Interactive voice response and text message (IVR-T) technology may improve hypertension control in under-resourced settings. We conducted a randomized clinical trial to determine whether an IVR-T intervention would improve blood pressure (BP), medication adherence and visit keeping among adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico. Two hundred and ninety-five participants were randomly assigned to IVR-T (N = 148) or to usual care (N = 147). The IVR-T arm received reminders for clinic visits, messages to reschedule missed clinic visits, monthly medication refill reminders, weekly motivational messages, and a blood pressure cuff. The usual care arm received no messages. The primary outcome was change in systolic BP (SBP) between baseline and 12 months. Secondary outcomes included change in SBP between baseline and 6 months, change in diastolic BP (DBP) at 6 and 12 months, self-reported adherence at 6 months, and the proportion of missed primary care clinic appointments. The intervention did not affect SBP or DBP at 6 or 12 months. The 12-month change in SBP/DBP was 1.66/1.10 mm Hg in usual care and 0.23/1.34 mm Hg in the intervention group (P values = .57 and .88, respectively). Self-reported medication adherence improved comparably in both groups, and there was no difference in percentage of kept visits. Several features of study design, clinic operations, and data transfer were barriers to demonstrating effectiveness.",2020,Hg in the intervention group (P values = .57,"['adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico', 'individuals with hypertension', 'Two hundred and ninety-five participants']","['IVR-T', 'IVR-T intervention', 'interactive voice response and text message intervention', 'Interactive voice response and text message (IVR-T) technology']","['change in SBP between baseline and 6\xa0months, change in diastolic BP (DBP) at 6 and 12\xa0months, self-reported adherence', 'change in systolic BP (SBP', 'blood pressure (BP), medication adherence and visit keeping', 'percentage of kept visits', 'Self-reported medication adherence', 'SBP or DBP', 'SBP/DBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5191218', 'cui_str': '290'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333118', 'cui_str': 'Retained'}]",295.0,0.0501178,Hg in the intervention group (P values = .57,"[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Schroeder', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Moore', 'Affiliation': 'Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Spero M', 'Initials': 'SM', 'LastName': 'Manson', 'Affiliation': 'Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Baldwin', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Goodrich', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Allen S', 'Initials': 'AS', 'LastName': 'Malone', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Pieper', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}, {'ForeName': 'Meredith P', 'Initials': 'MP', 'LastName': 'Fort', 'Affiliation': 'Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Son-Stone', 'Affiliation': 'First Nations Community HealthSource, Albuquerque, NM, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'First Nations Community HealthSource, Albuquerque, NM, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Steiner', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Aurora, CO, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13909']
1072,32520828,Autoimmune Hepatitis in Children: Prednisone Plus Azathioprine Versus Cyclosporine: A Randomized Trial.,"OBJECTIVE


The aim of this study was to find the outcome and adverse effects of 2 initial treatments in children with autoimmune hepatitis, prednisone (PRED) plus azathioprine (AZA) versus cyclosporine (CsA).
STUDY DESIGN


Between December 2008 and February 2012, 50 consecutive patients were centrally randomized to 1 of 2 treatment arms. Group 1: PRED was indicated at a dose of 1 to 2 mg · kg · day (up to 60 mg/day) and AZA at a dose of 1 to 2 mg · kg · day. Group 2: CsA was administered at a dose of 4 mg · kg · day orally divided into 2 doses. After remission, all patients were given a combination of PRED at 0.3 to 0.5 mg · kg · day and AZA at 1 to 2 mg · kg · day. Children presenting liver failure were placed on a triple immunosuppressive regimen if this condition persisted after 1 week of treatment, after liver function normalization they were switched back to their initial scheme.
RESULTS


A total of 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 versus CsA: 13.6 weeks (P < 0.0081). All children recovered liver function in a mean time of 32 ± 26 days. Cushingoid syndrome was more frequently observed with PRED-AZA (P < 0.001) and gingival hypertrophy with CsA (P < 0.001). A significant increase in body mass index was observed in all patients from initial treatment to remission, being greater with PRED-AZA.
CONCLUSIONS


Similar outcomes were obtained with PRED plus AZA or CsA treatments. Either therapeutic strategy could be used according to the particular characteristics of each patient. Triple immunosuppression was beneficial in patients with liver failure at onset.",2020,"RESULTS


26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","['Children presenting liver failure (LF', '50 consecutive patients', 'Autoimmune Hepatitis in Children', 'patients with liver failure at onset', 'Between 12/2008-2/2012', 'children with autoimmune hepatitis (AIH']","['prednisone (PRED) plus azathioprine (AZA) vs cyclosporine (CsA', 'Cyclosporine', 'Triple immunosuppression', 'AZA', 'Prednisone Plus Azathioprine', 'CsA']","['Cushingoid syndrome', 'effectiveness and safety', 'PRED', 'gingival hypertrophy with CsA', 'liver function', 'body mass index (BMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0332601', 'cui_str': 'Cushingoid facies'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0017567', 'cui_str': 'Hypertrophy of gingiva'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.0972557,"RESULTS


26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","[{'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Cuarterolo', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Ciocca', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'López', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'Nutrition Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Álvarez', 'Affiliation': 'Department of Pediatrics, CHU-Sainte Justine, University of Montreal, Montreal, Canada.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002776']
1073,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND


Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown.
RESEARCH QUESTION


To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces?
METHODS


Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position.
RESULTS


Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
SIGNIFICANCE


It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05).
","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044']
1074,32529045,Surgery for women with endometrioma prior to  in vitro  fertilisation: proposal for a feasible multicentre randomised clinical trial in the UK.,"STUDY QUESTION


Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF?
SUMMARY ANSWER


A randomised controlled trial (RCT) comparing surgery versus no surgery to endometrioma prior to IVF is only feasible in UK if an adaptive rather than traditional study design is used; this would minimise resource wastage and complete the trial in an acceptable time frame.
WHAT IS KNOWN ALREADY


There is wide variation in the management of endometriomas prior to IVF, with decisions about treatment being influenced by personal preferences.
STUDY DESIGN SIZE AND DURATION


This was a mixed-methods study consisting of an online survey of clinicians, a focus group and individual interviews with potential trial participants.
PARTICIPANTS/MATERIALS SETTING METHODS


Endometriosis and fertility experts across the UK were invited to participate in an online anonymised questionnaire. Potential future trial participants were recruited from a tertiary care fertility centre and invited to participate in either individual interviews or focus groups.
MAIN RESULTS AND THE ROLE OF CHANCE


Clinicians and potential trial participants confirmed the need for an RCT to inform the management of an endometrioma prior to IVF. There were 126 clinicians who completed the survey, and the majority (70%) were willing to recruit to a trial. Half of those who responded indicated that they see at least 10 eligible women each year. The main barriers to recruitment were waiting lists for surgery and access to public funding for IVF. One focus group ( n  = 7) and five interviews were conducted with potential trial participants ( n  = 3) and their partners ( n  = 2). The findings from these discussions highlighted that recruitment and retention in a potential RCT could be improved by coordination between IVF and surgical services such that an operation does not delay IVF or affect access to public funding. Live birth was considered the most important outcome with an improvement of at least 10% considered the minimum acceptable by both patients and clinicians.
LIMITATIONS REASONS FOR CAUTION


This feasibility study captured views of clinicians across the UK, but as patients were from a single Scottish centre, their views may not be representative of other areas with limited public funding for IVF.
WIDER IMPLICATIONS OF THE FINDINGS


There is a need for an appropriately powered RCT to establish whether or not surgical treatment of endometrioma prior to IVF improves live birth rates. There are logistical issues to be considered due to limited number of participants, funding of IVF and waiting times. These could be overcome in a RCT by using an adaptive design which would include a prospectively planned opportunity for modification of specified aspects of the study design based on interim analysis of the data, coordination of IVF treatments and endometriosis surgeries and international collaboration. Similar principles could be used for other questions in fertility where a traditional approach for randomised trials is not feasible.
STUDY FUNDING/COMPETING INTERESTS


Funding was received from the NHS Grampian R&D pump priming fund (RG14437-12). S.B. is Editor-in-Chief of HROPEN, and A.W.H. is Deputy Editor of HROPEN. Neither was involved in the review of this manuscript. L.S. reports grants from CSO and NIHR to do endometriosis research, outside the submitted work. K.C. reports grants from NIHR/HTA and CSO during the conduct of the study. J.H.e., A.W.H., J.D., S.B.r., K.B., G.B., J.H.u. and K.G. report no conflict of interest.",2020,"Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF?
","['Endometriosis and fertility experts across the UK were invited to participate in an online anonymised questionnaire', '126 clinicians who completed the survey, and the majority (70%) were willing to recruit to a trial', 'Potential future trial participants were recruited from a tertiary care fertility centre and invited to participate in either individual interviews or focus groups', 'women with endometrioma prior to  in vitro  fertilisation']",['surgery versus no surgery to endometrioma prior to IVF'],['live birth rates'],"[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0269102', 'cui_str': 'Endometriotic cyst'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}]",126.0,0.207264,"Is it feasible to undertake a randomised controlled trial to establish whether surgical removal of endometrioma or not, improves live birth rates from IVF?
","[{'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Maheshwari', 'Affiliation': 'Aberdeen Fertility Centre, NHS Grampian, Aberdeen AB25 2ZL, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Healey', 'Affiliation': 'Health Service Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Gynecology, NHS Grampian, Aberdeen AB25 2ZN, UK.'}, {'ForeName': 'Lucky', 'Initials': 'L', 'LastName': 'Saraswat', 'Affiliation': 'Gynecology, NHS Grampian, Aberdeen AB25 2ZN, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""The Queen's Medical Research InstituteEdinburgh, EH16 4TJ, UK.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Faculty of Medical & Health Sciences, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Clinical Trials Unit, Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brian', 'Affiliation': ""Women's Voices, Royal College of Obstetricians and Gynaecologists, London, UK.""}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Burns', 'Affiliation': 'Infertility Network, London, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}]",Human reproduction open,['10.1093/hropen/hoaa012']
1075,32520870,Sedentary Time and Physical Activity in Older Women Undergoing Exercise Training.,"Older adults have low rates meeting the physical activity (PA) guidelines and high sedentary time. Low PA and excessive sedentary time have been linked to adverse health outcomes. Less is known about whether exercise training influences sedentary time and PA in various intensities.
PURPOSE


This study aimed to examine the effects of a 16-wk aerobic exercise training on time spent being sedentary and on light-intensity PA (LPA) and moderate- to vigorous-intensity PA (MVPA) and step numbers in older women.
METHODS


Inactive women (n = 61; age = 65.5 ± 4.3 yr) participated in moderate-intensity walking of either a low or a moderate dose (33.6 and 58.8 kJ·kg body weight per week, respectively). They wore a SenseWear Mini Armband at baseline and at end intervention to determine sedentary, LPA, and MVPA time and step numbers.
RESULTS


Time being sedentary, or spent on LPA and MVPA, did not change differently by exercise groups with different doses (all P values for group-time interaction >0.580). Overall, time being sedentary reduced from baseline to end intervention by approximately 39 min·d (P < 0.001), and LPA increased by 19 min·d (P = 0.003). MVPA time increased (P < 0.001), which was primarily accounted for by the supervised exercise. Interestingly, daily steps increased more in the moderate-dose than the low-dose group (P = 0.023 for group-time interaction; 33.6% and 19.8% median increase in moderate- and low-dose groups, respectively). Also, there were individual differences in these changes.
CONCLUSION


Results indicated that, on average, older women did not reduce time of LPA or MVPA outside the exercise program or increase sedentary time as a result of participating in the exercise program.",2020,"Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003).","['older women', 'Older Women Undergoing Exercise Training', 'Older adults', 'Inactive women (n = 61; age = 65.5 ± 4.3 years) participated in moderate-intensity walking of either a low or a moderate dose (33.6 and 58.8 kJ·kg body weight per week, respectively']","['exercise training', 'aerobic exercise training']","['sedentary time', 'time spent being sedentary and on PA time of light (LPA) and moderate-to-vigorous (MVPA) intensities, and step numbers', 'Sedentary Time and Physical Activity', 'MVPA time', 'LPA']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}]",61.0,0.0344794,"Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003).","[{'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Charity B', 'Initials': 'CB', 'LastName': 'Breneman', 'Affiliation': ''}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sparks', 'Affiliation': ''}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002407']
1076,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757']
1077,32216457,Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients.,"OBJECTIVES


The authors have previously tried to develop a model for the testing of novel drug candidates for migraine, using the headache and migraine provoking agent cilostazol. Previous studies have used sumatriptan tablets as the validating drug, but they were not sufficiently effective. In this study we test the effect of subcutaneous sumatriptan on cilostazol induced headache in patients with migraine without aura.
METHOD


Thirty patients with migraine without aura received 200 mg cilostazol on two different study days. The induced headache was treated with subcutaneous sumatriptan in a randomized, double-blind cross-over design. The patients filled out a self-reported headache questionnaire until 12 h after cilostazol.
RESULTS


All 30 patients experienced headache (range 3-10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the placebo day. Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003). The difference between headache intensity on the sumatriptan day and the placebo day was significant at both 2 h ( p  = 0.01) and 4 h ( p  = 0.0007) after treatment.
CONCLUSION


Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. The cilostazol model may be useful as a tool to test the potential of new anti-migraine drugs. Trial registration:  The study is registered on clinicaltrials.gov (NCT03422796).",2020,Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003).,"['Thirty patients with migraine without aura received 200 mg cilostazol on two different study days', 'All 30 patients experienced headache (range 3-10) on both study days and the headache fulfilled the criteria for a migraine-like attack in 73% on the sumatriptan day and in 77% on the', 'patients with migraine without aura', 'migraine patients']","['Subcutaneous sumatriptan', 'subcutaneous sumatriptan', 'Sumatriptan', 'placebo']","['headache questionnaire', 'cilostazol induced headache', 'headache intensity', 'headache score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0055729', 'cui_str': 'cilostazol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0650812,Sumatriptan injection reduced the headache score 2 h after treatment ( p  = 0.003).,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Helene Rønde', 'Initials': 'HR', 'LastName': 'Bjerg', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Centre and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420915166']
1078,32531115,"Efficacy of cold atmospheric plasma vs. diclofenac 3% gel in patients with actinic keratoses: a prospective, randomized and rater-blinded study (ACTICAP).",,2020,Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development.,"['Actinic keratoses (AK', 'patients with actinic keratoses']","['Cold atmospheric plasma (CAP', 'CAP', 'cold atmospheric plasma versus diclofenac']",[],"[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]",[],,0.0942484,Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Koch', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Salva', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wirtz', 'Affiliation': 'SanaSkin, Zürich, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hadaschik', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Varaljai', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roesch', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16735']
1079,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1080,32513308,Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection.
TRIAL DESIGN


This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor.
PARTICIPANTS


Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA.
INTERVENTION AND COMPARATOR


The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis.
MAIN OUTCOMES


The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period.
RANDOMIZATION


Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability.
BLINDING (MASKING)


The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5.
TRIAL STATUS


Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis.
","['hospitalized patients with COVID-19', 'patients hospitalized with severe COVID-19 used a similar ordinal scale', 'severely ill adults with COVID-19', 'Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6', 'enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm', 'hospitalized adults with severe SARS-CoV-2 infection', 'Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so', 'Columbia University Irving Medical Center in New York, USA']","['lopinavir- ritonavir', 'possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO', 'human anti-SARS-CoV-2 convalescent plasma', 'anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform', 'anti-SARS-CoV-2 plasma versus one unit']","['efficacy and safety', 'time to clinical improvement', 'Death', 'cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021613', 'cui_str': 'Inspiratory reserve volume'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.269262,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis.
","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04422-y']
1081,32524948,Rapid Reduction of  Campylobacter  Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.,"Campylobacter  has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in  Campylobacter  species after azithromycin treatment, generating the hypothesis that a decrease in  Campylobacter  may contribute to observations of reduction in mortality following azithromycin distribution.",2020,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"['Preschool Children after Oral', 'preschool children treated with']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'placebo']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812107,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0940']
1082,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND


Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol.
MATERIALS AND METHODS


We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model.
RESULTS


The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving.
CONCLUSIONS


Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028']
1083,32536320,"Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer.","Objective:  Virtual reality (VR), a novel and highly immersive technology, offers promise in addressing potential psychological impacts of cancer treatments and hospitalization. The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer. Secondary aims were to identify issues and opportunities related to the adoption and clinical implementation of VR in pediatric oncology settings.  Method:  The study was conducted at The Royal Children's Hospital (RCH), Melbourne, Australia. Thirty multidisciplinary oncology health care professionals participated in an initial test of VR intervention usability (Stage 1). Ninety oncology inpatients (7-19 years) and their parent caregivers participated in a pilot randomized controlled study to examine the effectiveness of an Immersive VR therapeutic intervention (Stage 2). This mixed methods study reports Stages 1 and 2 quantitative and qualitative data related to VR feasibility and acceptability.  Results:  Results indicate favorable perceptions from health care professionals with respect to ease of use and usefulness of VR, and had positive intentions to use it in the future. Parent caregivers reported high acceptability of VR for their hospitalized child. Patients reported high satisfaction of the VR intervention within minimal adverse effects. Barriers and facilitators to VR use with seriously ill children and specific recommendations for content development were elicited.  Conclusion:  This study shows that there are several potential clinical uses for Immersive VR intervention, beyond medical procedural distraction, to support psychological adjustment to hospitalization and patient quality of life.",2020,The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer.,"['Ninety oncology inpatients (7-19 years) and their parent caregivers participated', 'Children and Adolescents With Cancer', 'Thirty multidisciplinary oncology health care professionals participated in an initial test of VR intervention usability (Stage 1', 'hospitalized patients with cancer', ""Royal Children's Hospital (RCH), Melbourne, Australia""]","['Immersive VR therapeutic intervention (Stage 2', 'Immersive VR therapeutic intervention', 'Immersive Virtual Reality Intervention', 'Virtual reality (VR), a novel and highly immersive technology']",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",[],90.0,0.0155384,The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': 'Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Tara-Jane', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220917859']
1084,32510976,Single-Session Bronchial Thermoplasty Guided by  129 Xe Magnetic Resonance Imaging. A Pilot Randomized Controlled Clinical Trial.,"Rationale:  Adverse events have limited the use of bronchial thermoplasty (BT) in severe asthma. Objectives:  We sought to evaluate the effectiveness and safety of using  129 Xe magnetic resonance imaging ( 129 Xe MRI) to prioritize the most involved airways for guided BT. Methods:  Thirty subjects with severe asthma were imaged with volumetric computed tomography and  129 Xe MRI to quantitate segmental ventilation defects. Subjects were randomized to treatment of the six most involved airways in the first session (guided group) or a standard three-session BT (unguided). The primary outcome was the change in Asthma Quality of Life Questionnaire score from baseline to 12 weeks after the first BT for the guided group compared with after three treatments for the unguided group. Measurements and Main Results:  There was no significant difference in quality of life after one guided compared with three unguided BTs (change in Asthma Quality of Life Questionnaire guided = 0.91 [95% confidence interval, 0.28-1.53]; unguided = 1.49 [95% confidence interval, 0.84-2.14];  P  = 0.201). After one BT, the guided group had a greater reduction in the percentage of poorly and nonventilated lung from baseline when compared with unguided (-17.2%;  P  = 0.009). Thirty-three percent experienced asthma exacerbations after one guided BT compared with 73% after three unguided BTs ( P  = 0.028). Conclusions:  Results of this pilot study suggest that similar short-term improvements can be achieved with one BT treatment guided by  129 Xe MRI when compared with standard three-treatment-session BT with fewer periprocedure adverse events.",2020,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).",['Thirty subjects with severe asthma were imaged with volumetric CT and 129Xe MRI to quantitate segmental ventilation defects'],"['standard three-session BT (unguided', '129 Xe Magnetic Resonance Imaging', 'Single-Session Bronchial Thermoplasty Guided by']","['quality of life', 'percent of poorly/non-ventilated lung', 'change in Asthma Quality of Life Questionnaire (AQLQ) score', 'asthma exacerbations', 'AQLQ and asthma control tests (ACT']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860888', 'cui_str': 'Spiral computed tomography scan'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}]",30.0,0.171046,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).","[{'ForeName': 'Chase S', 'Initials': 'CS', 'LastName': 'Hall', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Quirk', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Lew', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kozlowski', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Thomen', 'Affiliation': 'University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Woods', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mugler', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Gallagher', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Iulian C', 'Initials': 'IC', 'LastName': 'Ruset', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'F William', 'Initials': 'FW', 'LastName': 'Hersman', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-1021OC']
1085,32517390,Effectiveness of Suprascapular Nerve Pulsed Radiofrequency Treatment for Hemiplegic Shoulder Pain: A Randomized-Controlled Trial.,"BACKGROUND


Hemiplegic shoulder pain is one of the most common complications after stroke. Although there are many treatment strategies for this complication, sometimes very resistant cases are also seen.
OBJECTIVES


To evaluate the effect of suprascapular nerve pulsed radiofrequency (PRF) treatment for hemiplegic shoulder pain (HSP).
STUDY DESIGN


A prospective randomized-controlled trial.
SETTING


University hospital.
METHODS


This study included 30 patients with HSP following stroke. The patients were randomly assigned to receive PRF to the suprascapular nerve (PRF group, n = 15) or suprascapular nerve block (NB) with lidocaine (NB group, n = 15). The patients were randomized into 2 groups (n = 15 both). In addition, the patients received physical therapy to the shoulder, including hot pack, transcutaneous electrical nerve stimulation, and stretching and strengthening exercise (5 days per week for 3 weeks in a total of 15 sessions). Visual Analog Scale (VAS) for pain, the Goal Attainment Scale (GAS) during upper-body dressing, and shoulder range of motion (ROM) were assessed at baseline, 1 month, and 3 months after the procedure.
RESULTS


Between the groups, comparison revealed that decrease in the VAS score was statistically significantly higher at the first (3.5 1.9 vs. 1.2 1.0) and third month (4.2 1.7 vs. 1.2 0.9) in the PRF group compared with the NB group (P < 0.01). The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05).
LIMITATION


There is a need for further studies with a longer follow-up period.
CONCLUSIONS


In light of these findings, the combination of PRF applied to the suprascapular nerve and physical therapy was superior to the combination of suprascapular NB and physical therapy.
KEY WORDS


Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve.",2020,"The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05).
","['30 patients with HSP following stroke', 'Hemiplegic Shoulder Pain', 'hemiplegic shoulder pain (HSP', 'University hospital']","['physical therapy to the shoulder, including hot pack, transcutaneous electrical nerve stimulation, and stretching and strengthening exercise', 'Suprascapular Nerve Pulsed Radiofrequency Treatment', 'suprascapular nerve pulsed radiofrequency (PRF', 'PRF to the suprascapular nerve (PRF group, n = 15) or suprascapular nerve block (NB) with lidocaine (NB']","['VAS score', 'GAS score', 'shoulder ROM', 'Visual Analog Scale (VAS) for pain, the Goal Attainment Scale (GAS) during upper-body dressing, and shoulder range of motion (ROM', 'Hemiplegic shoulder, stroke, pain, radiofrequency, suprascapular nerve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C3179076', 'cui_str': 'Pulsed Radio Frequency Treatment'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}]",30.0,0.0551158,"The PRF group had significantly higher increases in shoulder ROM compared with the NB group (P < 0.05).The positive changes in GAS score at month 3 in the PRF group was significantly higher than that in the NB group (P < 0.05).
","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Alanbay', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Kesan State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Berke', 'Initials': 'B', 'LastName': 'Aras', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Kastamonu Rehabilitation Centre, Kastamonu, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Kesikburun', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}, {'ForeName': 'Selvinaz', 'Initials': 'S', 'LastName': 'Kizilirmak', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Gülhane Medical School, Gaziler Physical Therapy and Rehabilitation Research and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Yasar', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}, {'ForeName': 'Arif Kenan', 'Initials': 'AK', 'LastName': 'Tan', 'Affiliation': 'Gülhane Military Medical Academy, Department of Physical Medicine and Rehabilitation, Turkish Armed Forces Rehabilitation Center, Ankara, Turkey.'}]",Pain physician,[]
1086,32517391,Conservative Treatment Versus Ultrasound-Guided Injection in the Management of Meralgia Paresthetica: A Randomized Controlled Trial.,"BACKGROUND


Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), in which conservative treatment options are not always sufficient.
OBJECTIVES


The aim of this study was to evaluate the efficacy of ultrasound (US)-guided LFCN injection in the management of MP by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy.
STUDY DESIGN


A prospective, randomized, sham-controlled study.
SETTING


Health Sciences University Training and Research Hospital in Turkey.
METHODS


Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study. Patients were randomly assigned to 3 groups: (1) US-guided injection group, (2) TENS group, and (3) sham TENS group. The blockage of the LFCN was performed for therapeutic MP management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days per week for 2 weeks, for 20 minutes per daily session in group 2, and sham TENS was applied to group 3 with the same protocol. Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36]) at onset (T1), 15 days after treatment (T2), and 1 month after treatment (T3) were used for evaluation. Patients and the investigator who evaluated the results were blinded to the treatment protocol during the study period.
RESULTS


A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period. The mean changes in painDETECT and SWMt scores showed a statistically significant difference between groups in favor of group 1 at T2 and T3 compared with T1 (P < 0.05). There was no statistically significant difference between groups in terms of VAS, SF-36, and PSQI scores (P > 0.05). In-group analysis of VAS scores showed a statistically significant decrease in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of the VAS scores statistically significant decrease was shown in T2 compared with T1 in group 2 (P < 0.05). In-group analysis of painDETECT scores statistically significant decrease was shown in T2 and T3 compared with T1 in all groups (P < 0.05). In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05). In-group analysis of SF-36 and PSQI scores, there was no statistically significant decrease in all groups (P > 0.05).
LIMITATIONS


The limitation of the study was a short follow-up period.
CONCLUSIONS


US-guided LFCN injection and TENS may be therapeutic options for MP treatment, however, for patients with neuropathic pain symptoms, US-guided LFCN injection may be a safe and alternative method to conservative treatment.
KEY WORDS


Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation.",2020,In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05).,"['Patients diagnosed with LFCN compression with clinical and electrophysiological findings were included in this study', 'A total of 54 of the 62 patients (group 1 n = 17, group 2 n = 16, group 3 n = 21) completed the study, 3 patients from group 1, 4 patients from group 2, and 1 patient from group 3 dropped out during the follow-up period', 'patients with neuropathic pain symptoms', 'Meralgia Paresthetica', 'Health Sciences University Training and Research Hospital in Turkey']","['transcutaneous electrical nerve stimulation (TENS) therapy and sham TENS therapy', 'ultrasound (US)-guided LFCN injection', 'conventional TENS', 'US-guided injection group, (2) TENS group, and (3) sham TENS', 'Conservative Treatment Versus Ultrasound-Guided Injection', 'Meralgia paresthetica (MP', 'LFCN injection and TENS', 'Meralgia paresthetica, ultrasound-guided injection, transcutaneous electrical nerve stimulation']","['VAS, SF-36, and PSQI scores', 'SF-36 and PSQI scores', 'mean changes in painDETECT and SWMt scores', 'Visual Analog Scale (VAS), painDETECT questionnaire, Semmes-Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life (36-Item Short Form Health Survey [SF-36', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0228912', 'cui_str': 'Structure of lateral femoral cutaneous nerve'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0152110', 'cui_str': 'Meralgia paresthetica'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228912', 'cui_str': 'Structure of lateral femoral cutaneous nerve'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0394678', 'cui_str': 'Conventional transcutaneous electrical nerve stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0152110', 'cui_str': 'Meralgia paresthetica'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",3.0,0.0400468,In-group analysis of SWMt scores statistically significant decrease was shown in T2 and T3 compared with T1 in group 1 (P < 0.05).,"[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Kiliç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gebze Fatih State Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Feyza Ünlü', 'Initials': 'FÜ', 'LastName': 'Özkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Duygu Geler', 'Initials': 'DG', 'LastName': 'Külcü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Haydarpasa Numune Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Öztürk', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Akpinar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ilknur', 'Initials': 'I', 'LastName': 'Aktas', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Health Sciences, Fatih Sultan Mehmet Education and Training Hospital, Istanbul, Turkey.'}]",Pain physician,[]
1087,32517392,Clinical Study of Spinal Cord Stimulation and Pulsed Radiofrequency for Management of Herpes Zoster-Related Pain Persisting Beyond Acute Phase in Elderly Patients.,"BACKGROUND


Postherpetic neuralgia (PHN) occurs in 9% to 34% of herpes zoster (HZ) patients, and the incidence of PHN is positively correlated with age. A number of patients suffer from poor therapeutic effects or intolerable side effects and need to accept minimally invasive analgesia.
OBJECTIVES


This study aimed to investigate the effects of spinal cord stimulation (SCS) and pulsed radiofrequency (PRF) on the treatment of elderly patients with HZ-related pain persisting beyond the acute phase.
STUDY DESIGN


A prospective, randomized-controlled trial.
SETTING


Research was conducted at the National Pain Management and Research Center, China-Japan Friendship Hospital (Beijing, China).
METHODS


We selected 63 patients aged over 50 years with zoster-related pain of 1 to 6 months onset. They were randomly divided into an SCS group and a PRF group. In the SCS group, the stimulus electrodes were placed in the affected spinal ganglion segment of the epidural space for 2 weeks. In the PRF group, the radiofrequency needle was percutaneously punctured in the affected dorsal root ganglion. The main outcome measures were the Numeric Rating Scale (NRS-11) score, response rate, and complete remission rate. The secondary endpoint was defined as the use of analgesics and calcium channel antagonists.
RESULTS


The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) . The effective rate of pain management was in the range of 56.67% to 81.25%, and the complete pain relief rate ranged from 37% to 71%. The number of patients still using analgesics and calcium channel antagonists after operation were significantly less than those pre-operation (P < .001). Univariate and multivariate logistic regression analyses showed that the operation method, age, gender, and course of disease did not affect surgical efficacy.
LIMITATIONS


The main limitation of this study is that all the cases were from the same center.
CONCLUSION


It therefore can be concluded that SCS and PRF can effectively relieve PHN.
KEY WORDS


Spinal cord stimulation, pulsed radiofrequency, postherpetic neuralgia.",2020,"The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) .","['Elderly Patients', 'Research was conducted at the National Pain Management and Research Center, China-Japan Friendship Hospital (Beijing, China', 'elderly patients with HZ-related pain persisting beyond the acute phase', '63 patients aged over 50 years with zoster-related pain of 1 to 6 months onset']","['Spinal Cord Stimulation and Pulsed Radiofrequency', 'spinal cord stimulation (SCS) and pulsed radiofrequency (PRF', 'radiofrequency needle', 'SCS']","['Numeric Rating Scale (NRS-11) score, response rate, and complete remission rate', 'complete pain relief rate', 'NRS-11 score', 'use of analgesics and calcium channel antagonists', 'effective rate of pain management']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",63.0,0.0296937,"The NRS-11 score in the SCS group decreased to 2.90 ± 1.83 (1 week post operation) and 4.37 ± 2.43 (24 weeks post operation), while that in the PRF group decreased to 3.13 ± 1.78 and 4.23 ± 2.64, respectively (compared with baseline, P < .001); there was no significant difference between the 2 groups (P > .05) .","[{'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pain Medicine, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou, China.'}, {'ForeName': 'Haining', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Bifa', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sima', 'Affiliation': 'National Pain Management and Research Center, China-Japan Friendship Hospital, Beijing, China.'}]",Pain physician,[]
1088,32517393,Dexmedetomidine Added to Bupivacaine versus Bupivacaine in Transincisional Ultrasound-Guided Quadratus Lumborum Block in Open Renal Surgeries: A Randomized Trial.,"BACKGROUND


General anesthesia (GA) is the preferred anesthetic modality for open renal surgeries to ensure a patent airway while the patient is in the lateral decubitus position. However, these surgeries are usually accompanied by severe postoperative pain with increased requirements for multimodal pain management strategies. Regional blocks provide better postoperative pain control with less systemic opioid consumption.
OBJECTIVES


The aim of this study was to describe the ultrasound (US)-guided transincisional quadratus lumborum block (TiQLB) as a new approach, and to compare the addition of dexmedetomidine to bupivacaine versus bupivacaine alone for TiQLB in combination with GA regarding postoperative analgesia and adverse effects in open renal surgery.
STUDY DESIGN


A prospective, randomized, double-blind, controlled trial.
SETTING


Ain Shams University Hospitals.
METHODS


Eighty patients who were scheduled for an elective open renal surgery, aged 20 to 65 years, of either gender, and American Society of Anesthesiologists physical status I to II were enrolled in the study. They were randomly allocated into 2 equal groups: group dexmedetomidine-bupivacaine (DB) (n = 40) in which patients received combined GA plus TiQLB with 30 mL bupivacaine 0.25% plus 1 mu g/kg dexmedetomidine, and group bupivacaine (B) (n = 40) in which patients received combined GA plus TiQLB with 30 mL bupivacaine 0.25% only. The primary outcome was the total morphine consumption among both groups, whereas the secondary outcomes were the Visual Analog Scale (VAS) scores and the time to first analgesic requirement during the first 24 hours. Postoperative side effects, such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression, were also recorded.
RESULTS


Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001). Time to first analgesic requirement was prolonged in patients in the DB group (18.6 ± 2.4 hours) in comparison to patients in the B group (7.3 ± 1.1 hours). Ten minutes after the block there was a significant reduction in mean blood pressure and heart rate in the DB group than in the B group. Regarding postoperative adverse effects, sedation scores were higher in the DB group than in the B group, postoperative nausea, vomiting, and shivering were significantly higher in the B group than in the DB group. Bradycardia was significantly more frequent among the DB group. Although nonsignificant, pruritus was more frequent in the B group than in the DB group. No cases of respiratory depression were reported in both groups.
LIMITATIONS


The used technique US-guided TiQLB could be performed in open renal surgeries only.
CONCLUSIONS


The new approach US-guided TiQLB was effective and easy to be performed. Adding dexmedetomidine to bupivacaine in TiQLB was associated with potent and prolonged postoperative analgesia with fewer postoperative adverse effects.
KEY WORDS


Quadratus lumborum block, dexmedetomidine, open renal surgery, postoperative pain, bupivacaine.",2020,"RESULTS


Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001).","['Ain Shams University Hospitals', 'Eighty patients who were scheduled for an elective open renal surgery, aged 20 to 65 years, of either gender, and American Society of Anesthesiologists physical status', 'Open Renal Surgeries']","['Bupivacaine', 'bupivacaine', 'dexmedetomidine-bupivacaine (DB', 'combined GA plus TiQLB with 30 mL bupivacaine 0.25% plus 1 mu g/kg dexmedetomidine, and group bupivacaine', 'Dexmedetomidine', 'General anesthesia (GA', 'ultrasound (US)-guided transincisional quadratus lumborum block (TiQLB', 'dexmedetomidine', 'combined GA plus TiQLB']","['total morphine consumption and lower VAS scores', 'Bradycardia', 'Postoperative side effects, such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression', 'Visual Analog Scale (VAS) scores and the time to first analgesic requirement', 'postoperative adverse effects, sedation scores', 'total morphine consumption', 'Quadratus lumborum block, dexmedetomidine, open renal surgery, postoperative pain, bupivacaine', 'respiratory depression', 'Time to first analgesic requirement', 'postoperative nausea, vomiting, and shivering', 'mean blood pressure and heart rate', 'pruritus']","[{'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",80.0,0.0898718,"RESULTS


Patients in the DB group experienced lower total morphine consumption and lower VAS scores when compared with patients in the B group (P < 0.001).","[{'ForeName': 'Amin M', 'Initials': 'AM', 'LastName': 'Alansary', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Urology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Marwa A K', 'Initials': 'MAK', 'LastName': 'Elbeialy', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]",Pain physician,[]
1089,32521299,Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.,"PURPOSE


Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS.
METHODS


Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events.
RESULTS


All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups.
CONCLUSIONS


BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.",2020,"Side effect profiles were not significantly different among the groups.
","['chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery', 'Patients with bilateral CRSwNP who had undergone ESS', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['buffered hypertonic seawater (BHS) (n\xa0=\xa048) or physiological seawater (PS) ', 'nonECRSwNP + BHS', 'noneosinophilic CRSwNP (nonECRSwNP', 'BHS', 'buffered hypertonic seawater']","['Mucosal edema formation', '22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events', 'mucosal edema and crusting', 'LEKS and SCT relative to PS', 'LEKS and SCT', 'SNOT-22 scores, VAS scores, and LKES over time']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0772097,"Side effect profiles were not significantly different among the groups.
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Zhi-Qun', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Tu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. Electronic address: yjholly@email.ncu.edu.cn.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102554']
1090,32686643,Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome.,"STUDY OBJECTIVES


To evaluate the long-term effects of a mandibular advancement device (MAD) on stress symptoms and cognitive function in patients with upper airway resistance syndrome (UARS) compared with placebo.
METHODS


This study was a randomized placebo-controlled clinical trial. Thirty UARS patients were randomized into 2 groups: placebo and MAD groups. UARS criteria were the presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea-hypopnea index ≤ 5 events/h and a respiratory disturbance index > 5 events/h of sleep, and/or flow limitation in more than 30% of total sleep time. All patients completed the Rey Auditory-Verbal Learning Test, the Logical Memory test, the Stroop Color Test, the Trail Making Test, the Digit Symbol Substitution Test, and Inventory of Stress Symptoms. Cognition protocol was defined based on the most used neuropsychological tests in the literature. Evaluations were performed before and after 1.5 years of treatment.
RESULTS


Mean adherence to placebo and to MAD was 6.6 ± 2.6 and 6.1 ± 2.4 h/night, respectively. Side effects reported by MAD group were minor and short-term. There was no statistically significant difference in Rey Auditory-Verbal Learning Test, Logical Memory test, Stroop Color Test, Trail Making Test, and Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups. Inventory of Stress Symptoms score decreased at the alert phase and the resistance phase after 1.5 years of MAD treatment compared to the placebo.
CONCLUSIONS


Mandibular advancement devices were effective in decreasing stress symptoms in UARS patients after 1.5 years of treatment.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome; URL: https://clinicaltrials.gov/ct2/show/record/NCT02636621; Identifier: NTC02636621.",2020,"There was no statistically significant difference in RAVLT, Logical Memory Test, Stroop Color Test, Trail Making Test, Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups.","['UARS patients after 1.5-years of treatment', 'Thirty UARS patients', 'Upper Airway Resistance Syndrome', 'patients with upper airway resistance syndrome', 'patients with UARS compared with placebo']","['Placebo', 'mandibular advancement device (MAD', 'appliance therapy', 'placebo and MAD', 'Oral Appliance', 'MAD', 'placebo']","['stress symptoms and cognitive function', 'RAVLT, Logical Memory Test, Stroop Color Test, Trail Making Test, Digit Symbol Substitution Test', 'stress symptoms', 'ISSL score', 'Rey Auditory-Verbal Learning Test (RAVLT), the Logical Memory Test, the Stroop Color Test, the Trail Making Test, the Digit Symbol Substitution Test and Inventory of Stress Symptoms (ISSL', 'Side effects', 'Mean adherence', 'presence of sleepiness (Epworth Sleepiness Scale ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea/hypopnea index (AHI) ≤ 5 and a respiratory disturbance index (RDI) > 5 events/hour of sleep, and/or flow limitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1319384', 'cui_str': 'Upper airway resistance syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",30.0,0.120518,"There was no statistically significant difference in RAVLT, Logical Memory Test, Stroop Color Test, Trail Making Test, Digit Symbol Substitution Test before and after 1.5 years of treatment in both groups.","[{'ForeName': 'Luciana B M', 'Initials': 'LBM', 'LastName': 'de Godoy', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ksdy M M', 'Initials': 'KMM', 'LastName': 'Sousa', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana de Oliveira', 'Initials': 'LO', 'LastName': 'Palombini', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Dalva', 'Initials': 'D', 'LastName': 'Poyares', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cibele', 'Initials': 'C', 'LastName': 'Dal-Fabbro', 'Affiliation': 'Instituto do Sono, São Paulo, Brazil.'}, {'ForeName': 'Thais M', 'Initials': 'TM', 'LastName': 'Guimarães', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sonia M', 'Initials': 'SM', 'LastName': 'Togeiro', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8698']
1091,32531622,Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.,"BACKGROUND AND AIM


Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries.
METHODS AND MATERIALS


In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS.
RESULTS


Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05).
CONCLUSION


Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.",2020,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"['78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled', 'middle ear']","['packing materials (Gelfoam and silastic sheets', 'cartilage tympanoplasty with silastic sheet versus Gelfoam packing', 'silastic sheet or gelfoam']","['Success', 'perforation area percentage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C1289829', 'cui_str': 'Packing material'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",78.0,0.0554288,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"[{'ForeName': 'Mahtab Rabbani', 'Initials': 'MR', 'LastName': 'Anari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Miratashi', 'Initials': 'AM', 'LastName': 'Yazdi', 'Affiliation': 'Surgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Kazemi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atie', 'Initials': 'A', 'LastName': 'Moghtadaie', 'Affiliation': 'Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Farbod', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hd_emami@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102588']
1092,32538880,Efficacy of Osteopathic Manipulative Treatment on postural control in Parkinsonian patients with Pisa syndrome: A pilot randomized placebo-controlled trial.,"BACKGROUND


Pisa syndrome (PS) is a clinical condition frequently associated with Parkinson's disease (PD). It is characterized by a trunk lateral flexion higher than 10 degrees and reversible when lying. One pathophysiological hypothesis is the altered verticality perception, due to a somatosensory impairment. Osteopathic Manipulative Treatment (OMT) manages fascial-system alterations, linked to somatic dysfunctions. Fascial system showed to be implicated in proprioceptive sensibility.
OBJECTIVE


The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry.
METHODS


In this single-blinded trial we studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received four OMT plus MIRT, for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) with DIERS formetrics was also performed.
RESULTS


At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01). In the experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).
DISCUSSION


Among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.",2020,"At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01).","['Parkinsonian patients with Pisa syndrome', 'PD-PS patients by stabilometry', '24 PD-PS patients']","['placebo', 'trunk lateral flexion (TLF', 'Osteopathic Manipulative Treatment (OMT', 'osteopathic manipulative treatment', 'multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received four OMT plus MIRT']","['mean inclination reduction', 'eye closed sway area assessment', 'OMT efficacy', 'proprioceptive sensibility', 'postural control and TLF improvement', 'delta ECSA and delta TLF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920233', 'cui_str': 'Pisa syndrome'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",24.0,0.0908228,"At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT - 326.00±491.24 mm2, p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zarucchi', 'Affiliation': 'Department of Brain Injury and Parkinson\'s Disease Rehabilitation, Ospedale ""Moriggia-Pelascini"", Gravedona ed Uniti (Como), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vismara', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, University of Turin, Turin, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Frazzitta', 'Affiliation': 'Department of Brain Injury and Parkinson\'s Disease Rehabilitation, Ospedale ""Moriggia-Pelascini"", Gravedona ed Uniti (Como), Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mauro', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, University of Turin, Turin, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Priano', 'Affiliation': '""Rita Levi Montalcini"" Department of Neurosciences, University of Turin, Turin, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Maestri', 'Affiliation': 'Department of Biomedical Engineering, Istituti Clinici Scientifici Maugeri Spa Società Benefit, IRCCS, Montescano, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergna', 'Affiliation': 'Department of Clinical Research, SOMA Istituto Osteopatia Milano, Italy.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Tarantino', 'Affiliation': 'Department of Clinical Research, SOMA Istituto Osteopatia Milano, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203068']
1093,32538882,"Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia.","BACKGROUND


While Walkbot-assisted locomotor training (WLT) provided ample evidence on balance and gait improvements, the therapeutic effects on cardiopulmonary and psychological elements as well as fall confidence are unknown in stroke survivors.
OBJECTIVE


The present study aimed to compare the effects of Walkbot locomotor training (WLT) with conventional locomotor training (CLT) on balance and gait, cardiopulmonary and psychological functions and fall confidence in acute hemiparetic stroke.
METHODS


Fourteen patients with acute hemiparetic stroke were randomized into either the WLT (60 min physical therapy + 30 min Walkbot-assisted gait training) or CLT (60 min physical therapy + 30 min gait training) groups, 7 days/week over 2 weeks. Clinical outcomes included the Berg Balance Scale (BBS), Functional Ambulation Category (FAC), heart rate (HR), Borg Rating of Perceived Exertion (BRPE), Beck Depression Inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale. The analysis of covariance (ANCOVA) was conducted at P < 0.05.
RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P < 0.05), but not on BBS (P = 0.061).
CONCLUSIONS


Our results provide novel, promising clinical evidence that WLT improved balance and gait function as well as cardiopulmonary and psychological functions, and fall confidence in acute stroke survivors who were unable to ambulate independently.",2020,"RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
","['acute hemiparetic stroke', 'Fourteen patients with acute hemiparetic stroke', 'acute hemiplegia', 'acute stroke survivors']","['Walkbot locomotor training (WLT) with conventional locomotor training (CLT', 'WLT (60-minute physical therapy +30-minute Walkbot-assisted gait training) or CLT (60\u200amin physical therapy +30\u200amin gait training', 'innovative hip-knee-ankle interlimb coordinated robot training', 'While Walkbot-assisted locomotor training (WLT', 'WLT']","['ambulation, cardiopulmonary function, depression, and fall confidence', 'balance and gait function', 'BBS', 'Berg balance scale (BBS), functional ambulation category (FAC), heart rate (HR) and Borg rating of perceived exertion (BRPE), Beck depression inventory-II (BDI-II), and the activities-specific balance confidence (ABC) scale', 'FAC, HR, BRPE, BDI-II, and ABC scale', 'balance and gait, cardiopulmonary and psychological functions and fall confidence']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0419113', 'cui_str': 'Locomotor training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}]",14.0,0.02254,"RESULTS


ANCOVA showed that WLT showed superior effects, compared to CLT, on FAC, HR, BRPE, BDI-II, and ABC scale (P <  0.05), but not on BBS (P = 0.061).
","[{'ForeName': 'Chanhee', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Yonsei University, Wonju, Republic of Korea.'}, {'ForeName': 'Mooyeon', 'Initials': 'M', 'LastName': 'Oh-Park', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Dohle', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bialek', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Friel', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Moss Rehabilitation, Philadelphia, PA, USA.'}, {'ForeName': 'Hermano Igo', 'Initials': 'HI', 'LastName': 'Krebs', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, MA, USA.'}, {'ForeName': 'Joshua Sung H', 'Initials': 'JSH', 'LastName': 'You', 'Affiliation': 'Department of Physical Therapy, Sports Movement Artificial-Intelligence Robotics Technology (SMART) Institute, Yonsei University, Wonju, Republic of Korea.'}]",NeuroRehabilitation,['10.3233/NRE-203086']
1094,32542474,A Resilience Intervention for Adults with Type 2 Diabetes: Proof-of-Concept in Community Health Centers.,"BACKGROUND


Given the psychological stress associated with managing type 2 diabetes (T2D), resilience-promoting interventions may particularly benefit populations experiencing high levels of stress (e.g., racial/ethnic minority and lower-income individuals). Federally qualified Community Health Centers (CHCs) primarily serve these patients and are therefore ideal settings for resilience-promoting T2D programs. This proof-of-concept study tested the Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention within a CHC.
METHOD


Thirty-five patients with T2D (M age = 51 years, 71% female, 60% Hispanic, 69% annual household income < $20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups. In this treatment-only design, resilience resources, self-management behaviors, and physical and mental health outcomes were measured at baseline and 6 months.
RESULTS


Attendance (M = 7.66/10) and program satisfaction (M = 6.79/7) were high. Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85). Large increases in self-management behaviors (d = 1.38) and number of steps (d = 1.11) were also observed. Participants lowered A1C from baseline (M = 8.79%) to 6 months (M = 8.11%; d = .50), along with diabetes distress (d = 1.31), depressive symptoms (d = .80), and general perceived stress (d = .55).
CONCLUSION


This study demonstrated the ability of the RB-DSME to improve resilience resources, self-management behaviors, and health outcomes among racial/ethnic minority and lower-income patients with T2D at clinics within a CHC. A larger, randomized trial should more rigorously test the RB-DSME in this clinical setting.",2020,"Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85).","['Adults with Type 2 Diabetes', 'racial/ethnic minority and lower-income patients with T2D at clinics within a CHC', 'Thirty-five patients with T2D (M age\u2009=\u200951\xa0years, 71% female, 60% Hispanic, 69% annual household income <\u2009$20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups']","['RB-DSME', 'Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention']","['adaption to stress', 'adaptive coping', 'resilience resources, self-management behaviors, and physical and mental health outcomes', 'diabetes distress', 'diabetes empowerment', 'self-management behaviors', 'depressive symptoms', 'program satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",35.0,0.0303655,"Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85).","[{'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Dubois', 'Affiliation': 'Department of Internal Medicine, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'H Matthew', 'Initials': 'HM', 'LastName': 'Lehrer', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Erum Z', 'Initials': 'EZ', 'LastName': 'Whyne', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Steinhardt', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, 2109 San Jacinto Blvd, Stop D3700, Austin, TX, 78712, USA. msteinhardt@austin.utexas.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09894-5']
1095,32542578,Does Organizing Mentor-Mentee Matches into Small Groups Enhance Treatment Effects in a Site-Based Mentoring Program for Adolescents? Results of a Randomized Controlled Trial.,"Formal youth mentoring is an effective intervention strategy for healthy development during adolescence. Modest and varied effects across programs, however, demonstrate a need to identify factors that can reliably improve outcomes for mentored youth. The purpose of this randomized controlled trial was to test the relative impact of embedding mentee-mentor matches in small groups on youth outcomes and to examine whether this effect was mediated by the quality of the program setting and mentoring relationship quality. Participants included 676 adolescents (M age  = 14.21, range = 11-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program. Most measured outcomes in both conditions (i.e., mentoring groups and a control condition in which pairs were not embedded in a group) were significantly better at post-intervention as compared to pre-intervention. The hypothesis that mentoring groups would have stronger impact, however, was not supported. The results imply that organizing mentor-mentee matches in small groups offer no advantage or disadvantage and that youth may be able to garner benefit from both structures.",2020,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","['Participants included 676 adolescents (M age \u2009=\u200914.21, range\u2009=\u200911-18; 41.6% female) enrolled in Campus Connections, a site-based youth mentoring program', 'healthy development during adolescence']",[],[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",[],[],676.0,0.0674145,"The hypothesis that mentoring groups would have stronger impact, however, was not supported.","[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Haddock', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA. shelley.haddock@colostate.edu.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota, St. Paul, MN, 55108, USA.'}, {'ForeName': 'Hyanghee', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Henry', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lucas-Thompson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Toni S', 'Initials': 'TS', 'LastName': 'Zimmerman', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Krafchick', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Gereon F', 'Initials': 'GF', 'LastName': 'Fredrickson', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Yetz', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lise M', 'Initials': 'LM', 'LastName': 'Youngblade', 'Affiliation': 'Colorado State University, Fort Collins, CO, 80523, USA.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01267-1']
1096,32546726,Phase II trial of CPX-351 in patients with acute myeloid leukemia at high risk for induction mortality.,"CPX-351 is a liposomal formulation of cytarabine/daunorubicin with a 5:1 fixed molar ratio. We investigated the safety and efficacy of escalating doses of CPX-351 in patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial. Patients were randomized to receive 50 or 75 units/m 2  on days 1, 3, and 5. Once safety was established, a 100 units/m 2  arm was opened. Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100 units/m 2  arms, respectively. The composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was lowest with 50 units/m 2  (19%) compared with 75 units/m 2  (38%) and 100 units/m 2  (44%) (P = 0.35). The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04). Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia (34%), pneumonia (23%), and sepsis (16%). CPX-351 at 75 units/m 2  has favorable safety and efficacy for AML patients at high risk of induction mortality with some tolerating the standard dose of 100 units/m 2 .",2020,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","['patients with acute myeloid leukemia at high risk for induction mortality', 'Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100\u2009units/m 2  arms, respectively', 'patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial']","['cytarabine/daunorubicin', 'CPX-351']","['median OS', 'safety and efficacy', 'Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia', 'composite complete remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2346682', 'cui_str': 'CPX-351'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",56.0,0.0785846,"The 50 units/m 2  arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2  respectively (P = 0.04).","[{'ForeName': 'Ghayas C', 'Initials': 'GC', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Prithviraj', 'Initials': 'P', 'LastName': 'Bose', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Naqvi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kornblau', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maro', 'Initials': 'M', 'LastName': 'Ohanian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. jorge.cortes@augusta.edu.'}]",Leukemia,['10.1038/s41375-020-0916-8']
1097,32546347,"Re: Timothy J. Wilt, Tien N. Vo, Lisa Langsetmo, et al. Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT). Eur Urol 2020;77:713-724: External Validity of the Updated Prostate Cancer Intervention Versus Observation Trial (PIVOT).",,2020,,['Clinically Localized Prostate Cancer'],"['Radical Prostatectomy or Observation', 'Updated Prostate Cancer Intervention', 'https://doi.org/10.1016/j.eururo.2020.02.009']",[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0236809,,"[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Rakic', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Keeley', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Abdollah', 'Affiliation': 'Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA. Electronic address: firas.abdollah@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2020.05.002']
1098,32519235,The long-term consequence of salivary contamination at various stages of adhesive application and clinically feasible remedies to decontaminate.,"OBJECTIVE


To analyse the bond quality in dentine post-ageing after salivary contamination and decontamination at different stages of dental adhesive application.
MATERIALS AND METHODS


A total of 1120 human dentine specimens were randomly allocated to 14 groups for four intervals (n = 20) to be treated with a self-etching (SE) and universal (U) adhesive. The saliva contamination and decontamination were implemented after surface preparation, after primer application (for SE) and after adhesive curing. The decontamination groups were either rinsed and air-dried or rinsed, air-dried and reapplied with adhesive. They were stored (37 °C, distilled water) for four intervals (1 week, 1 month, 3 months and 1 year) and subjected to shear bond strength (SBS) test at a crosshead speed of 0.5 mm/min.
RESULT


One-way ANOVA with Tukey's test (α = 0.05) revealed significant reduction in SBS in all the groups in U adhesive compared with the control group at 1 week (p < 0.0001) and in SE when the contamination took place after primer application. However, decontamination improved the SBS in SE but not in U adhesive. The univariate analysis confirmed significant influences (p < 0.0001) seen by treatment procedure ([Formula: see text]=0.075), type of adhesive ([Formula: see text] = 0.328), ageing ([Formula: see text] = 0.13), experimental groups ([Formula: see text] = 0.518), and the stage of influence ([Formula: see text] = 0.60).
CONCLUSION


Saliva contamination is detrimental after primer application in SE but, decontamination regained the SBS and maintained it over time. In U adhesive, SBS deteriorated over time irrespective of the contamination.
CLINICAL RELEVANCE


Salivary contamination showed different influences on SBS at various stages of restoration with contemporary dental adhesives.",2020,One-way ANOVA with Tukey's test (α = 0.05) revealed significant reduction in SBS in all the groups in U adhesive compared with the control group at 1 week (p < 0.0001) and in SE when the contamination took place after primer application.,['1120 human dentine specimens'],"['self-etching (SE) and universal (U) adhesive', 'rinsed and air-dried or rinsed, air-dried and reapplied with adhesive']",['SBS'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",1120.0,0.024381,One-way ANOVA with Tukey's test (α = 0.05) revealed significant reduction in SBS in all the groups in U adhesive compared with the control group at 1 week (p < 0.0001) and in SE when the contamination took place after primer application.,"[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Ludwig-Maximilians University, Goethestraße 70, 80336, Munich, Germany. poojanair8888@gmail.com.'}, {'ForeName': 'Nicoleta', 'Initials': 'N', 'LastName': 'Ilie', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Ludwig-Maximilians University, Goethestraße 70, 80336, Munich, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03307-3']
1099,32520900,Associations of pituitary-ovarian hormones and white matter hyperintensities in recently menopausal women using hormone therapy.,"OBJECTIVE


Little is known about how menopausal hormone treatment (HT) may influence the development of white matter hyperintensities (WMHs) in the brain. This study evaluated the associations of changes in levels of pituitary-ovarian hormones during HT and changes in WMH.
METHODS


Women (n = 78 adherent to treatment) enrolled in the Kronos Early Estrogen Prevention Study underwent brain magnetic resonance imaging, and blood collection before and after 48 months of randomization to 0.45 mg/d oral conjugated equine estrogen (oCEE) daily, 50 μg/d transdermal 17β estradiol (tE2), or placebo pills and patches. Women in the active treatment groups also received oral 200 mg/d micronized progesterone the first 12 days of the month. Estradiol (E2), estrone (E1), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum by high sensitivity liquid chromatography/mass spectrometry at baseline and following 48 months of HT. Longitudinal change in WMH volume was determined from fluid-attenuated inversion recovery magnetic resonance imaging using a semiautomated image segmentation algorithm.
RESULTS


Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline. After 48 months of treatment, smaller increases in WMH associated with decreases in FSH from baseline in the tE2 group and increases in E1 in both tE2 and oCEE groups. Changes in LH did not associate with changes in WMH in any group.
CONCLUSIONS


Circulating levels of pituitary-ovarian hormones associate with changes in WMH volume in recently menopausal women using HT. Whether these relationships would be influenced by different doses of tE2 or oCEE remains to be determined. : Video Summary:http://links.lww.com/MENO/A590.",2020,"RESULTS


Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline.","['Women (n\u200a=\u200a78 adherent to treatment) enrolled in the Kronos', '50']","['transdermal 17β estradiol (tE2), or placebo pills and patches', ' Video Summary:http://links.lww.com/MENO/A590', 'brain magnetic resonance imaging, and blood collection before and after 48 months of randomization to 0.45\u200amg/d oral conjugated equine estrogen (oCEE', 'hormone therapy', 'menopausal hormone treatment (HT', 'oral 200\u200amg/d micronized progesterone']","['Estradiol (E2), estrone (E1), follicle-stimulating hormone (FSH), and luteinizing hormone (LH', 'WMH', 'Serum levels of FSH, LH, E1, or E2', 'levels of pituitary-ovarian hormones', 'FSH', 'WMH volume']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0729511', 'cui_str': 'Ovarian hormone'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.216075,"RESULTS


Serum levels of FSH, LH, E1, or E2 did not associate with WMH volume at baseline.","[{'ForeName': 'Juliana M', 'Initials': 'JM', 'LastName': 'Kling', 'Affiliation': ""Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, AZ, 13737 North 92nd Street, Scottsdale, AZ 85260.""}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Departments of Surgery and Physiology and Biomedical Engineering, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nirubol', 'Initials': 'N', 'LastName': 'Tosakulwong', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lesnick', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, MN.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001557']
1100,32530472,Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.,"Importance


Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment.
Objective


To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness.
Design, Setting, and Participants


This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019.
Interventions


A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes.
Main Outcomes and Measures


The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control.
Results


Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.
Conclusions and Relevance


An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population.
Trial Registration


ClinicalTrials.gov Identifier: NCT02127671.",2020,"Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.
","['Persons With Serious Mental Illness', 'adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs', 'adults with serious mental illness', '398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants', '269 participants randomized (mean [SD] age', 'Importance\n\n\nPersons with serious mental illness', '48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder', 'December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland']","['Comprehensive Cardiovascular Risk Reduction Intervention', 'multifaceted intervention incorporating behavioral counseling, care coordination, and care management']","['mean (SD) baseline FRS', 'FRS', 'change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event', 'overall cardiovascular disease risk', 'cardiovascular disease mortality rate', 'mean (SD) FRS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",269.0,0.170462,"Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months.
","[{'ForeName': 'Gail L', 'Initials': 'GL', 'LastName': 'Daumit', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Arlene T', 'Initials': 'AT', 'LastName': 'Dalcin', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Faith B', 'Initials': 'FB', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Towson, Maryland.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Jerome', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Deborah R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena.'}, {'ForeName': 'Jeanne B', 'Initials': 'JB', 'LastName': 'Charleston', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Gennusa', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Goldsholl', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Heller', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'McGinty', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Crum', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7247']
1101,32530518,"Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia for maintenance of labour analgesia: a two-centre, double-blind, randomised study†.","The programmed intermittent epidural bolus technique has shown superiority to continuous epidural infusion techniques, with or without patient-controlled epidural analgesia for pain relief, reduced motor block and patient satisfaction. Many institutions still use patient-controlled epidural analgesia without a background infusion, and a comparative study between programmed intermittent epidural bolus and patient-controlled epidural analgesia without a background infusion has not yet been performed. We performed a randomised, two-centre, double-blind, controlled trial of these two techniques. The primary outcome was the incidence of breakthrough pain requiring a top-up dose by an anaesthetist. Secondary outcomes included: motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes. We recruited 130 nulliparous women who received initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75 µg·ml -1  . The programmed intermittent epidural bolus group had a programmed bolus of 10 ml every hour, with on-demand patient-controlled epidural analgesia boluses of 5 ml with a 20 min lockout, and the patient-controlled epidural analgesia group had a 5 ml bolus with a 12 min lockout interval; the potential maximum volume per hour was the same in both groups. The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively. There was a significant difference in motor block (modified Bromage score ≤ 4) frequency between groups, programmed intermittent epidural bolus group 1 (1.6%) vs. patient-controlled epidural analgesia group 8 (13.1%); p = 0.015. The programmed intermittent epidural bolus group had greater local anaesthetic consumption with fewer patient-controlled epidural analgesia boluses. Patient satisfaction scores and obstetric or neonatal outcomes were not different between groups. In conclusion, we found that a programmed intermittent epidural bolus technique using 10 ml programmed boluses and 5 ml patient-controlled epidural analgesia boluses was superior to a patient-controlled epidural analgesia technique using 5 ml boluses and no background infusion.",2020,"The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively.",['130 nulliparous women who received'],"['initial spinal analgesia, and then epidural analgesia was initiated and maintained with either programmed intermittent epidural bolus or patient-controlled epidural analgesia using ropivacaine 0.12% with sufentanil 0.75\xa0µg·ml -1  ', 'Programmed intermittent epidural bolus vs. patient-controlled epidural analgesia']","['motor block; pain scores; patient satisfaction; local anaesthetic consumption; and obstetric and neonatal outcomes', 'motor block', 'local anaesthetic consumption', 'Patient satisfaction scores and obstetric or neonatal outcomes', 'incidence of breakthrough pain requiring a top-up dose by an anaesthetist', 'frequent breakthrough pain']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C1301707', 'cui_str': 'Patient controlled epidural analgesia'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4068882', 'cui_str': '0.75'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",130.0,0.136129,"The patients in the programmed intermittent epidural bolus group had less frequent breakthrough pain compared with the patient-controlled epidural analgesia group, 7 (10.9%) vs. 38 (62.3%; p < 0.0001), respectively.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Roofthooft', 'Affiliation': 'Department of Anaesthesiology, GZA Sint Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Barbé', 'Affiliation': 'Department of Anaesthesiology, University Hospitals Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schildermans', 'Affiliation': 'Department of Anaesthesiology, University Hospitals Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cromheecke', 'Affiliation': 'Department of Anaesthesiology, ZNA Middelheim Hospital, Antwerp, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Devroe', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Department of I-Biostat, KU Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Cardiovascular Sciences, KU Leuven, Belgium.'}]",Anaesthesia,['10.1111/anae.15149']
1102,32533785,"Apatinib plus Chemotherapy as a Second-Line Treatment in Unresectable Non-Small Cell Lung Carcinoma: A Randomized, Controlled, Multicenter Clinical Trial.","LESSONS LEARNED


The efficacy of second-line treatment for advanced non-small cell lung carcinoma (NSCLC) without a sensitizing driver gene mutation is still unsatisfactory. The combination of apatinib and chemotherapy improved progression-free survival in the second-line therapy of advanced NSCLC without a sensitizing mutation. This study offers a new treatment strategy for second-line treatment of such patients but requires confirmation in a larger multi-institutional trial.
BACKGROUND


This study explored the efficacy and safety of apatinib combined with single-agent chemotherapy versus single-agent chemotherapy in the second-line treatment of advanced non-small-cell lung carcinoma (NSCLC) without driver mutations.
METHODS


In this double-arm, open label, exploratory clinical study, we enrolled patients with unresectable locally advanced or advanced NSCLC without driver mutations that had progressed following first-line chemotherapy. The subjects were allocated into an experimental group and a control group by 2:1. The experimental group received apatinib combined with four cycles of docetaxel or pemetrexed until disease progression, intolerable toxicity, or discontinuation at the patient' request. The control group only received four cycles of docetaxel or pemetrexed. The primary endpoints were progression-free survival (PFS), and the secondary endpoints were overall survival (OS), disease control rate (DCR), and safety.
RESULTS


Thirty-seven patients were enrolled. The efficacy of 33 patients was evaluated. The median PFS was 5.47 versus 2.97 months, the DCR was 95% versus 73%, and the objective response rate (ORR) was 27% versus 9% in the experimental versus control group. The OS was still under follow-up. The most common adverse effects included hypertension, hand-foot skin reaction (HFSR), and fatigue.
CONCLUSION


Apatinib combined with single-agent chemotherapy may be a novel option for second-line treatment of advanced NSCLC.",2020,"The median PFS was 5.47 versus 2.97 months, the DCR was 95% versus 73%, and the objective response rate (ORR) was 27% versus 9% in the experimental versus control group.","['advanced non-small-cell lung carcinoma (NSCLC) without driver mutations', '33 patients', 'advanced non-small cell lung carcinoma (NSCLC', 'Unresectable Non-Small Cell Lung Carcinoma', 'enrolled patients with unresectable locally advanced or advanced NSCLC without driver mutations that had progressed following first-line chemotherapy', 'Thirty-seven patients were enrolled']","['docetaxel or pemetrexed', 'apatinib combined with single-agent chemotherapy versus single-agent chemotherapy', 'apatinib combined with four cycles of docetaxel or pemetrexed', 'second-line treatment', 'Apatinib plus Chemotherapy', 'apatinib and chemotherapy', 'Apatinib combined with single-agent chemotherapy']","['objective response rate (ORR', 'progression-free survival', 'efficacy and safety', 'overall survival (OS), disease control rate (DCR), and safety', 'hypertension, hand-foot skin reaction (HFSR), and fatigue', 'progression-free survival (PFS', 'DCR', 'median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",37.0,0.11037,"The median PFS was 5.47 versus 2.97 months, the DCR was 95% versus 73%, and the objective response rate (ORR) was 27% versus 9% in the experimental versus control group.","[{'ForeName': 'Zongyang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fujian Medical University, Fuzhou, People' Republic of China.""}, {'ForeName': 'Xiuyu', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhengwu', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People' Republic of China.""}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People' Republic of China.""}, {'ForeName': 'Jinhuo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Affiliated Union Hospital of Fujian Medical University, Fuzhou, People' Republic of China.""}, {'ForeName': 'Wenwu', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People' Republic of China.""}, {'ForeName': 'Wencui', 'Initials': 'W', 'LastName': 'Kong', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': ""First Affiliated Hospital of Fujian Medical University, Fuzhou, People' Republic of China.""}, {'ForeName': 'Zhongquan', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Xiangwu', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The 900th Hospital of Joint Logistic Support Force, PLA, Fuzhou, People' Republic of China.""}, {'ForeName': 'Wujin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Fujian People's Hospital, Fuzhou, People' Republic of China.""}, {'ForeName': 'Zhengbo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': ""Zhejiang Cancer Hospital, Hangzhou, People' Republic of China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ""Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, People' Republic of China.""}]",The oncologist,['10.1634/theoncologist.2020-0519']
1103,32541370,Can Treatment With Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial.,"PRECIS


Citicoline eyedrops in patients with progressing glaucoma.
PURPOSE


This study aimed to test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP)-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mm Hg or less.
DESIGN


This was a randomized, double-masked, placebo-controlled, multicenter 3-year study.
OUTCOMES


The outcomes studied were difference in the visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression and difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years.
METHODS


Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5 dB/y in the 2 years before enrollment despite IOP ≤18 mm Hg were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent a visual field examination with 24-2 and 10-2 strategies and RNFL assessment. Analysis of variance and linear models were used to test the differences between groups.
RESULTS


Eighty patients were randomized in the trial. The mean 3-year rates of progression were -1.03 (2.14) dB in the citicoline group and -1.92 (2.23) dB in the placebo group (P=0.07) for 24-2 MD and -0.41 (3.45) dB in the citicoline group and -2.22 (3.63) dB in the placebo group (P=0.02) for 10-2 MD. On average, patients receiving citicoline eyedrops lost 1.86 μm of RNFL in 3 years, versus 2.99 μm in the placebo group (P=0.02).
CONCLUSIONS


Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18 mm Hg.",2020,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"['y in the 2 years before enrolment despite IOP ≤18▒mmHg', 'Eighty patients', 'patients with progressing glaucoma', 'Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5▒', 'patients with progressing glaucoma despite IOP ≤18▒mmHg', 'patients with worsening of damage and IOP 18 mmHg or less']","['Placebo', 'citicoline eyedrops or placebo', 'citicoline eyedrops', 'Citicoline Eyedrops', 'PRECIS\n\n\nCiticoline eyedrops', 'citicoline eyedrops to intraocular pressure (IOP) -lowering treatment', 'placebo']","['disease progression', 'visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.500531,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Iester', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tranchina', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ottobelli', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Coco', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Calcatelli', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ancona', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cirafici', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Manni', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001565']
1104,32556481,"Deep learning detection of prostate cancer recurrence with  18 F-FACBC (fluciclovine, Axumin®) positron emission tomography.","PURPOSE


To evaluate the performance of deep learning (DL) classifiers in discriminating normal and abnormal  18 F-FACBC (fluciclovine, Axumin®) PET scans based on the presence of tumor recurrence and/or metastases in patients with prostate cancer (PC) and biochemical recurrence (BCR).
METHODS


A total of 251 consecutive  18 F-fluciclovine PET scans were acquired between September 2017 and June 2019 in 233 PC patients with BCR (18 patients had 2 scans). PET images were labeled as normal or abnormal using clinical reports as the ground truth. Convolutional neural network (CNN) models were trained using two different architectures, a 2D-CNN (ResNet-50) using single slices (slice-based approach) and the same 2D-CNN and a 3D-CNN (ResNet-14) using a hundred slices per PET image (case-based approach). Models' performances were evaluated on independent test datasets.
RESULTS


For the 2D-CNN slice-based approach, 6800 and 536 slices were used for training and test datasets, respectively. The sensitivity and specificity of this model were 90.7% and 95.1%, and the area under the curve (AUC) of receiver operating characteristic curve was 0.971 (p < 0.001). For the case-based approaches using both 2D-CNN and 3D-CNN architectures, a training dataset of 100 images and a test dataset of 28 images were randomly allocated. The sensitivity, specificity, and AUC to discriminate abnormal images by the 2D-CNN and 3D-CNN case-based approaches were 85.7%, 71.4%, and 0.750 (p = 0.013) and 71.4%, 71.4%, and 0.699 (p = 0.053), respectively.
CONCLUSION


DL accurately classifies abnormal  18 F-fluciclovine PET images of the pelvis in patients with BCR of PC. A DL classifier using single slice prediction had superior performance over case-based prediction.",2020,A DL classifier using single slice prediction had superior performance over case-based prediction.,"['patients with BCR of PC', 'A total of 251 consecutive  18 F-fluciclovine PET scans were acquired between September 2017 and June 2019 in 233 PC patients with BCR (18 patients had 2 scans', 'patients with prostate cancer (PC) and biochemical recurrence (BCR']","['18 F-FACBC (fluciclovine, Axumin®) positron emission tomography']","['area under the curve (AUC) of receiver operating characteristic curve', 'sensitivity and specificity', 'sensitivity, specificity, and AUC', 'performance of deep learning (DL) classifiers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0105421', 'cui_str': 'BCR protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C1311253', 'cui_str': 'fluciclovine F-18'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C1311253', 'cui_str': 'fluciclovine F-18'}, {'cui': 'C4310336', 'cui_str': 'Axumin'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]",28.0,0.0675701,A DL classifier using single slice prediction had superior performance over case-based prediction.,"[{'ForeName': 'Jong Jin', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'DimensionalMechanics Inc.®, Seattle, WA, USA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Franc', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Iagaru', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'Davidzon', 'Affiliation': 'Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford University, 300 Pasteur Dr, Stanford, CA, 94305, USA. gdavidzon@stanford.edu.'}]",European journal of nuclear medicine and molecular imaging,['10.1007/s00259-020-04912-w']
1105,32559644,Compensation of stochastic time-continuous perturbations during walking in healthy young adults: An analysis of the structure of gait variability.,"BACKGROUND


During everyday locomotion, we cope with various internal or external perturbations (e.g. uneven surface). Uncertainty exists on how unpredictable external perturbations increase noise within the motor system and if they are compensated by employing covariation of the limb joints or rather due to decreased sensitivity of an altered posture.
RESEARCH QUESTION


Do continuous stochastic perturbations affect the structure of gait variability in young and healthy adults?
METHODS


In a cross-over study, gait kinematics of 21 healthy young sports students were registered during treadmill walking with and without continuous stochastic perturbations. Using the TNC method, the following aspects were analyzed: (a) the sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints.
RESULTS


Compared to normal walking, gait variability was significantly increased (p < .001) during walking with perturbations. The negative effect of noise was partly compensated by improved 'covariation' of leg joints (p < .001). The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
SIGNIFICANCE


Increased motor noise due to external perturbations is partly compensated by improved covariation of the limb joints. However, the effect of an altered posture slightly affects gait variability. Further studies should focus on different populations (e.g. older participants) to see if they use the same mechanism (improved covariation) to compensate for stochastic perturbations.",2020,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","['young and healthy adults', '21 healthy young sports students', 'healthy young adults']",['treadmill walking with and without continuous stochastic perturbations'],"[""sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints"", 'gait variability', 'normal walking, gait variability', ""covariation' of leg joints""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",21.0,0.0319459,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001).
","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: mq.koch@gmx.de.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'Department of Sport and Movement Science, Institute of Sport Science, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany; Department for Exercise & Health, Institute of Sport Science, Leibniz University Hannover, Hannover, Germany. Electronic address: nils.eckardt@uni-oldenburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: daniel.hamacher@uni-jena.de.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.040']
1106,32563787,Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis.,"OBJECTIVES


The role of topical anti-infectives in acute exacerbations of chronic rhinosinusitis is controversial. Povidone-iodine is an anti-bacterial and anti-viral that is affordable and available over-the-counter and may demonstrate advantages over mupirocin as a sinus irrigation therapy. The objective was to compare povidone-iodine or mupirocin versus saline sinus irrigations for sinusitis exacerbations in post-surgery subjects as well as to assess tolerability of povidone-iodine sinus irrigations.
MATERIALS AND METHODS


This was a prospective single-blinded (clinician only) randomized controlled trial. Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture. They received povidone-iodine, mupirocin, or saline sinus irrigations, twice daily for 30 days. Outcomes were post-treatment culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary).
RESULTS


Of the 62 subjects analyzed, post-treatment culture negativity rate was higher in the MUP (14/20, 70%) group compared to the PI (9/21, 43%) and SAL (9/19, 47%) groups, although this was not significant (p = 0.29). Povidone-iodine sinus irrigations at the 1% concentration were very well-tolerated, similar to saline irrigations. There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3 [-0.7, 0.05] vs. saline -0.4 [-0.8, 0.05]; p = 0.86) or Lund-Kennedy endoscopic score (povidone-iodine -3.5 [-7, -0.5] vs. mupirocin -2 [-4, 2] vs. saline -3 [-5, 0]; p = 0.45) change. No serious adverse effects were reported.
CONCLUSIONS


In patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations achieved a better post-treatment culture ""control"" rate compared to saline and povidone-iodine. In addition, 1% povidone-iodine solution was well-tolerated as a sinus irrigation and may represent a feasible method for temporarily disinfecting the sinonasal cavity of bacteria and viruses such as COVID-19.",2020,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","['patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations', 'sinusitis exacerbations in post-surgery subjects', 'chronic rhinosinusitis', '62 subjects analyzed', 'Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture']","['povidone-iodine, mupirocin, or saline sinus irrigations', 'Povidone-iodine sinus irrigations', 'saline -3', 'povidone-iodine solution', 'saline and povidone-iodine', 'Povidone-iodine', 'povidone-iodine or mupirocin versus saline sinus irrigations', 'topical anti-infectives']","['Lund-Kennedy endoscopic score', 'Tolerability and effectiveness', 'Sinonasal Outcome Test-20 score', 'culture negativity rate', 'culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018154', 'cui_str': 'Gram-positive bacteria'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5197691', 'cui_str': 'SNOT-20'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.208361,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America. Electronic address: vlee39@uic.edu.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pottinger', 'Affiliation': 'Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, 1959 NE Pacific St, PO Box 356130, Courier BB-302, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Davis', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102604']
1107,32532631,Lower donor site morbidity and higher patient satisfaction with epidermal grafting in comparison to split thickness skin grafting: A randomized controlled trial (EPIGRAAFT Trial).,"BACKGROUND


Split thickness skin grafting (SSG) is an important modality for wound coverage; however, it leads to donor site morbidity. Epidermal grafting (EG) is a promising option for autologous skin grafting which offers minimal donor site morbidity, though it is not known if EG is an effective clinical alternative for SSG. This study compared the efficacy of EG as an alternative to SSG in terms of wound healing outcomes, donor site morbidity, patient satisfaction and adverse events.
METHODS


EPIGRAAFT is a Phase 2, randomized, open-label trial with two parallel groups: EG and SSG. Patients referred for skin grafting with a healthy granulating wound bed were included. The co-primary endpoints were the proportion of wounds healed and donor site healing time. The secondary endpoints include donor site morbidity measured using Vancouver Scar Scale, mean time for complete wound healing, patient satisfaction assessed using a validated skin grafting questionnaire and incidence of adverse events.
RESULTS


Of the 61 patients screened, 44 patients were randomized. There was no difference in the proportion of wounds healed at 6 weeks (p=0.366) and 3 months(p=0.24) as well as the mean time for wound healing (p=0.12). EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001). There were no adverse events reported.
CONCLUSION


This study demonstrated that EG has superior donor site outcomes with faster donor site healing and lower morbidity compared to SSG, while having comparable wound healing outcomes. Patients receiving EG also experienced higher donor site satisfaction compared to SSG. ClinicalTrials.gov identifier: NCT02535481.",2020,"EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001).","['Patients referred for skin grafting with a healthy granulating wound bed were included', '61 patients screened, 44 patients were randomized']","['Split thickness skin grafting (SSG', 'split thickness skin grafting', 'Epidermal grafting (EG']","['overall satisfaction', 'mean time for wound healing', 'lower donor site morbidity', 'faster donor site healing time', 'proportion of wounds healed and donor site healing time', 'higher donor site satisfaction', 'wound healing outcomes, donor site morbidity, patient satisfaction and adverse events', 'donor site morbidity measured using Vancouver Scar Scale, mean time for complete wound healing, patient satisfaction assessed using a validated skin grafting questionnaire and incidence of adverse events', 'proportion of wounds healed', 'Lower donor site morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",44.0,0.0865935,"EG resulted in lower donor site morbidity (p=0.001), faster donor site healing time (EG: 4.86 days vs. SSG: 21.32 days) (p<0.0001), and higher overall satisfaction (p<0.001).","[{'ForeName': 'Muholan', 'Initials': 'M', 'LastName': 'Kanapathy', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bystrzonowski', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Hachach-Haram', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Twyman', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Becker', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Institute of Medical Biology, A*Star, Immunos, Biomedical Grove, Singapore.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Richards', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Faculty of Health and Medical Sciences, University of Western Australia. Electronic address: toby.richards@uwa.edu.au.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mosahebi', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, United Kingdom; Department of Plastic and Reconstructive Surgery, Royal Free NHS Foundation Trust Hospital, London, United Kingdom.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.03.006']
1108,32548849,Duration of adhesion of swallowed alginates to distal oesophageal mucosa: implications for topical therapy of oesophageal diseases.,"BACKGROUND


We have previously shown, ex vivo, that alginate solutions can have a topical protective effect on oesophageal mucosal biopsies exposed to simulated gastric juice. Oesophageal mucosal impedance can measure the duration of mucosal adherence of ionic solutions since the impedance drops when the solution is present, and rises to baseline as the solution clears.
AIM


To investigate the in vivo duration of adhesion of swallowed alginate solution to distal oesophageal mucosa.
METHODS


We studied 20 healthy volunteers and 10 patients with heartburn. A pH-impedance catheter was inserted, and baseline distal channel oesophageal impedance measured. Healthy volunteers received 10 mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry (saline mixed with sucralose), given in a randomised, single-blinded order over three visits. Patients received either sodium alginate or placebo on two visits. Initial impedance drop was measured, then 1-minute mean impedance was measured each minute until ≥75% recovery to baseline.
RESULTS


In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01). In patients, sodium alginate adhered to the oesophageal mucosa for longer than placebo (9.0 (5.4) vs 3.7 (4.1), P < 0.01).
CONCLUSIONS


Sodium alginate solution adhered to the oesophageal mucosa for significantly longer than placebo or viscous slurry. This demonstrates that alginates could confer a protective benefit due to mucoadhesion and can be a basis for further development of topical protectants and for topical drug delivery in oesophageal disease.",2020,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","['oesophageal diseases', 'healthy volunteers', '20 healthy volunteers and 10 patients with heartburn', 'distal oesophageal mucosa', 'Healthy volunteers']","['sodium alginate or placebo', '10\xa0mL of either sodium alginate (Gaviscon Advance), Gaviscon placebo (no alginate) or viscous slurry ', 'saline mixed with sucralose', 'swallowed alginate solution', 'placebo']",['oesophageal mucosa'],"[{'cui': 'C0014852', 'cui_str': 'Disorder of esophagus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]","[{'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0227176', 'cui_str': 'Esophageal mucous membrane structure'}]",20.0,0.0734851,"In healthy volunteers, sodium alginate adhered to the oesophageal mucosa for longer than placebo or viscous slurry (10.4 [8.7] minutes vs 1.1 [1.6] vs 3.6 [4.0], P < 0.01).","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Sonmez', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sifrim', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Woodland', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15884']
1109,32548864,The effect of a hydrogel made by Nigella sativa L. on acne vulgaris: A randomized double-blind clinical trial.,"Nigella sativa L. (black seed) is one of the main medicinal plants frequently cited in traditional Persian medicine manuscripts for management of acne vulgaris. The present study was designed to investigate the efficacy of a topical preparation from N. sativa in acne vulgaris. In a randomized double-blind controlled clinical trial, 60 patients (30 patients in treatment and 30 in placebo group) were randomly received N. sativa hydrogel (standardized based on thymoquinone) or placebo hydrogel, twice daily for 60 days. The Investigator's Global Assessment (IGA) grading score was recorded for each patient. Moreover, acne disability index (ADI) was evaluated using a standard questionnaire filled out by the patients at the beginning and end of the study. A 78% mean reduction in the IGA score on the N. sativa-treated group was recorded compared with 3.3% on the vehicle-treated one. Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months. Also, ADI was decreased 63.49% in the treatment versus 4.5% in the placebo groups. No adverse event was recorded. N. sativa hydrogel had significant effects on improving the symptoms of acne vulgaris with acceptable tolerability.",2020,"Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months.","['60 patients (30 patients in treatment and 30 in placebo group', 'acne vulgaris']","['Nigella sativa L. (black seed', 'sativa hydrogel (standardized based on thymoquinone) or placebo hydrogel', 'hydrogel made by Nigella sativa L', 'placebo']","['acne disability index (ADI', 'IGA score', 'number of comedones, papules, and pustules', 'ADI', ""Investigator's Global Assessment (IGA) grading score"", 'symptoms of acne vulgaris with acceptable tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0076611', 'cui_str': 'thymoquinone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221228', 'cui_str': 'Comedone'}, {'cui': 'C0332563', 'cui_str': 'Papule'}, {'cui': 'C0241157', 'cui_str': 'Pustule'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}]",60.0,0.334872,"Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months.","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Soleymani', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Zargaran', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Farzaei', 'Affiliation': 'Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Iranpanah', 'Affiliation': ""Student's Research Committee, Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.""}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Heydarpour', 'Affiliation': 'Social Development & Health Promotion Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Najafi', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roja', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6739']
1110,32551736,A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders.,"OBJECTIVES


To investigate the effectiveness of Body Project groups delivered virtually (vBP) by peer educators for prevention of eating disorders.
METHOD


In a randomized controlled trial vBP groups (N = 149) were compared with a placebo (expressive writing, EW: N = 148) over 24-month follow-up and to a waitlist control condition (N = 146) over 6-month follow-up among females (15-20 years old) with body image concerns. The primary outcome was incidence of eating disorder onset over 2-year follow-up measured by blinded diagnostic interviews. Waitlist participants were offered the vBP after 6 months.
RESULTS


The incidence of eating disorders onset over 24 months follow up were 3 in vBP (2.0%) and 13 in EW (8.8%), a significant difference; Hazard Ratio (Experiment B) = 0.26, 95% confidence interval (CI) [0.075, 0.92], p = .037. Incidence of eating disorder onset in vBP participants was 77% less than in EW participants. The vBP participants generally showed significantly greater reduction in eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal compared with the waitlist participants at postintervention and 6-month follow-up, and in eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal compared with the EW participants at postintervention, and 6-, 12-, 18-, or 24-months follow-up. EW participants reported significantly greater reduction in clinical impairment and body dissatisfaction at postintervention compared with the waitlist participants.
CONCLUSIONS


The present reduction in the incidence of eating disorders is notable given that the intervention was implemented virtually, rather than in-person. The vBP might be a viable option for future evaluation of scalable prevention of eating disorders. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The vBP participants generally showed significantly greater reduction in eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal compared with the waitlist participants at postintervention and 6-month follow-up, and in eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal compared with the EW participants at postintervention, and 6-, 12-, 18-, or 24-months follow-up.",['N = 146) over 6-month follow-up among females (15-20 years old) with body image concerns'],"['placebo (expressive writing, EW: N = 148) over 24-month follow-up and to a waitlist control condition', 'virtually delivered Body Project (vBP']","['eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal', 'incidence of eating disorder onset over 2-year follow-up measured by blinded diagnostic interviews', 'eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal', 'incidence of eating disorders', 'eating disorders', 'clinical impairment and body dissatisfaction', 'incidence of eating disorders onset', 'Incidence of eating disorder onset']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0072634', 'cui_str': 'PVB protocol'}]","[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",149.0,0.0645106,"The vBP participants generally showed significantly greater reduction in eating disorder symptoms, clinical impairment, body dissatisfaction, and internalization of thin ideal compared with the waitlist participants at postintervention and 6-month follow-up, and in eating disorder symptoms, restraint, body dissatisfaction, and internalization of thin ideal compared with the EW participants at postintervention, and 6-, 12-, 18-, or 24-months follow-up.","[{'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Division of Psychology.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Enö Persson', 'Affiliation': 'Department of Clinical Neuroscience.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Allzén', 'Affiliation': 'Stockholm University Brain Imaging Centre.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000506']
1111,32495411,Chronic antioxidant administration restores macrovascular function in patients with heart failure with reduced ejection fraction.,"NEW FINDINGS


What is the central question of this study? We aimed to examine oxidative stress, antioxidant capacity and macro- and microvascular function in response to 30 days of oral antioxidant administration in patients with heart failure with reduced ejection fraction. What is the main finding and its importance? We observed an approximately twofold improvement in macrovascular function, assessed via brachial artery flow-mediated dilatation, and a reduction in oxidative stress after antioxidant administration in patients with heart failure with reduced ejection fraction. The improvement in macrovascular function was reversed 1 week after treatment cessation. These findings have identified the potential of oral antioxidant administration to optimize macrovascular health in this patient group.
ABSTRACT


Heart failure with reduced ejection fraction (HFrEF) is characterized by macrovascular dysfunction and elevated oxidative stress that may be mitigated by antioxidant (AOx) administration. In this prospective study, we assessed flow-mediated dilatation (FMD) and reactive hyperaemia responses in 14 healthy, older control participants and 14 patients with HFrEF, followed by 30 days of oral AOx administration (1 g vitamin C, 600 I.U. vitamin E and 0.6 g α-lipoic acid) in the patient group. Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed. Patients with HFrEF had a lower %FMD (2.63 ± 1.57%) than control participants (5.62 ± 2.60%), and AOx administration improved %FMD in patients with HFrEF (30 days, 4.90 ± 2.38%), effectively restoring macrovascular function to that of control participants. In a subset of patients, we observed a progressive improvement in %FMD across the treatment period (2.62 ± 1.62, 4.23 ± 2.69, 4.33 ± 2.24 and 4.97 ± 2.56% at days 0, 10, 20 and 30, respectively, n = 12) that was abolished 7 days after treatment cessation (2.99 ± 1.78%, n = 9). No difference in reactive hyperaemia was evident between groups or as a consequence of the AOx treatment. Ferric reducing ability of plasma levels increased (from 6.08 ± 2.80 to 6.70 ± 1.59 mm, day 0 versus 30) and malondialdehyde levels decreased (from 6.81 ± 2.80 to 6.22 ± 2.84 μm, day 0 versus 30) after treatment. These findings demonstrate the efficacy of chronic AOx administration in attenuating oxidative stress, improving AOx capacity and restoring macrovascular function in patients with HFrEF.",2020,Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed.,"['14 healthy, older control participants and 14 patients with HFrEF, followed by 30\xa0days of oral AOx administration ', 'patients with HFrEF', 'patients with heart failure with reduced ejection fraction']","['vitamin\xa0E and 0.6\xa0g α-lipoic acid', 'oral antioxidant', 'Chronic antioxidant']","['Ferric reducing ability of plasma levels', 'Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma', 'malondialdehyde levels', 'oxidative stress', 'FMD', 'reactive hyperaemia', 'AOx capacity and restoring macrovascular function', 'oxidative stress, antioxidant capacity and macro- and microvascular function', 'macrovascular function', 'macrovascular function, assessed via brachial artery flow-mediated dilatation', 'flow-mediated dilatation (FMD) and reactive hyperaemia responses']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}]",,0.083719,Blood biomarkers of oxidative stress (malondialdehyde) and AOx capacity (ferric reducing ability of plasma) were also assessed.,"[{'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Alpenglow', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Soung Hun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Jarrett', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Drakos', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, UT, USA.'}]",Experimental physiology,['10.1113/EP088686']
1112,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744']
1113,32566737,"Development of an interactive e-learning software ""Histologie für Mediziner"" for medical histology courses and its overall impact on learning outcomes and motivation.","Objective:  To develop and evaluate an interactive histology learning software for medical students in the preclinical study phase. The educational design of the software was based on current learning theory models, such as the  Cognitive load theory, Cognitive theory of multimedia learning , and the  ARCS  model, so that the acquired knowledge can be repeated using a diversified design. Moreover, the learning effects achieved by using the software shall be evaluated. Apart from the software's usability, the influence of the learning theory principles on the students' motivation shall be assessed.  Methodology:  The software was evaluated using an experimental wait list control group with a pre-/post-test design (n=213). Depending on the group they were assigned to, students learned the histology contents of chapter ""Liver, gall bladder, pancreas"" using the traditional program of the Goethe University (n=65), the new interactive software (n=56), or without any of the two software versions (n=92). The influence of the different learning aids on the acquisition of knowledge was assessed with three questionnaires comprising four different multiple choice questions each. For the evaluation of the usability and motivational factors, a second test was added to the questionnaire of both software versions.  Results:  The interactive software was rated significantly better with regard to usability and motivational aspects than the traditional learning program ( F (7, 113)=12.48,  p <.001, partial η 2 =.436). Moreover, use of the interactive software resulted in a significant increase of knowledge acquisition as compared to the group of students who had learned without any of the two software versions (0.77,  p =.001).  Conclusion:  With regard to the histology contents, usability was comparable to the official learning program. Interactive elements and the educational design contributed to an increase of the factors that are essential for intrinsic motivation. Thus, our program can be valuable tool to supplement the curriculum as an additional service.",2020,"Results:  The interactive software was rated significantly better with regard to usability and motivational aspects than the traditional learning program ( F (7, 113)=12.48,  p <.001, partial η 2 =.436).",['medical students'],"['interactive histology learning software', 'students learned the histology contents of chapter ""Liver, gall bladder, pancreas"" using the traditional program of the Goethe University (n=65), the new interactive software']","['knowledge acquisition', 'usability and motivational aspects']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",,0.015395,"Results:  The interactive software was rated significantly better with regard to usability and motivational aspects than the traditional learning program ( F (7, 113)=12.48,  p <.001, partial η 2 =.436).","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Drees', 'Affiliation': 'Goethe University Frankfurt/Main, Dr. Senckenbergische Anatomie, Anatomy I, Clinical Neuroanatomy, Frankfurt/Main, Germany.'}, {'ForeName': 'Estifanos', 'Initials': 'E', 'LastName': 'Ghebremedhin', 'Affiliation': 'Goethe University Frankfurt/Main, Dr. Senckenbergische Anatomie, Anatomy I, Clinical Neuroanatomy, Frankfurt/Main, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Goethe University Frankfurt/Main, Educational Psychology, Interdisciplinary College for University Teaching (IKH), Frankfurt/Main, Germany.'}]",GMS journal for medical education,['10.3205/zma001328']
1114,32568400,Effect of Nocturnal Oxygen Therapy on Nocturnal Hypoxemia and Sleep Apnea Among Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters: A Randomized Clinical Trial.,"Importance


There are no established measures to prevent nocturnal breathing disturbances and other altitude-related adverse health effects (ARAHEs) among lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude.
Objective


To evaluate whether nocturnal oxygen therapy (NOT) prevents nocturnal hypoxemia and breathing disturbances during the first night of a stay at 2048 m and reduces the incidence of ARAHEs.
Design, Setting, and Participants


This randomized, placebo-controlled crossover trial was performed from January to October 2014 with 32 patients with COPD living below 800 m with forced expiratory volume in the first second of expiration (FEV1) between 30% and 80% predicted, pulse oximetry of at least 92%, not requiring oxygen therapy, and without history of sleep apnea. Evaluations were performed at the University Hospital Zurich (490 m, baseline) and during 2 stays of 2 days and nights each in a Swiss Alpine hotel at 2048 m while NOT or placebo treatment was administered in a randomized order. Between altitude sojourns, patients spent at least 2 weeks below 800 m. Data analysis was performed from January 1, 2015, to December 31, 2018.
Intervention


During nights at 2048 m, NOT or placebo (room air) was administered at 3 L/min by nasal cannula.
Main Outcomes and Measures


Coprimary outcomes were differences between NOT and placebo intervention in altitude-induced change in mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry and apnea-hypopnea index (AHI) measured by polysomnography during night 1 at 2048 m and analyzed according to the intention-to-treat principle. Further outcomes were the incidence of predefined ARAHE, other variables from polysomnography results and respiratory sleep studies in the 2 nights at 2048 m, clinical findings, and symptoms.
Results


Of the 32 patients included, 17 (53%) were women, with a mean (SD) age of 65.6 (5.6) years and a mean (SD) FEV1 of 53.1% (13.2%) predicted. At 490 m, mean (SD) SpO2 was 92% (2%) and mean (SD) AHI was 21.6/h (22.2/h). At 2048 m with placebo, mean (SD) SpO2 was 86% (3%) and mean (SD) AHI was 34.9/h (20.7/h) (P < .001 for both comparisons). Compared with placebo, NOT increased SpO2 by a mean of 9 percentage points (95% CI, 8-11 percentage points; P < .001), decreased AHI by 19.7/h (95% CI, 11.4/h-27.9/h; P < .001), and improved subjective sleep quality measured on a visual analog scale by 9 percentage points (95% CI, 0-17 percentage points; P = .04). During visits to 2048 m or within 24 hours after descent, 8 patients (26%) using placebo and 1 (4%) using NOT experienced ARAHEs (P < .001).
Conclusions and Relevance


Lowlanders with COPD experienced hypoxemia, sleep apnea, and impaired well-being when staying at 2048 m. Because NOT significantly mitigated these undesirable effects, patients with moderate to severe COPD may benefit from preventive NOT during high altitude travel.
Trial Registration


ClinicalTrials.gov Identifier: NCT02150590.",2020,"Compared with placebo, NOT increased SpO2 by a mean of 9 percentage points (95% CI, 8-11 percentage points; P < .001), decreased AHI by 19.7/h (95% CI, 11.4/h-27.9/h; P < .001), and improved subjective sleep quality measured on a visual analog scale by 9 percentage points (95% CI, 0-17 percentage points; P = .04).","['lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude', 'January to October 2014 with 32 patients with COPD living below 800 m with forced expiratory volume in the first second of expiration (FEV1) between 30% and 80% predicted, pulse oximetry of at least 92%, not requiring oxygen therapy, and without history of sleep apnea', '32 patients included, 17 (53%) were women, with a mean (SD) age of 65.6 (5.6) years and a mean (SD) FEV1 of 53.1% (13.2%) predicted', 'Patients With Chronic Obstructive Pulmonary Disease Traveling to 2048 Meters']","['NOT or placebo', 'Swiss Alpine hotel at 2048 m while NOT or placebo', 'nocturnal oxygen therapy (NOT', 'Nocturnal Oxygen Therapy', 'placebo']","['subjective sleep quality', 'incidence of predefined ARAHE, other variables from polysomnography results and respiratory sleep studies', 'SpO2', 'visual analog scale', 'altitude-induced change in mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry and apnea-hypopnea index (AHI', 'hypoxemia, sleep apnea', 'nocturnal hypoxemia and breathing disturbances', 'mean (SD) SpO2', 'decreased AHI', 'nocturnal breathing disturbances', 'Nocturnal Hypoxemia and Sleep Apnea']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0442514', 'cui_str': 'Hotel'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",32.0,0.299445,"Compared with placebo, NOT increased SpO2 by a mean of 9 percentage points (95% CI, 8-11 percentage points; P < .001), decreased AHI by 19.7/h (95% CI, 11.4/h-27.9/h; P < .001), and improved subjective sleep quality measured on a visual analog scale by 9 percentage points (95% CI, 0-17 percentage points; P = .04).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tsogyal D', 'Initials': 'TD', 'LastName': 'Latshang', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sayaka S', 'Initials': 'SS', 'LastName': 'Aeschbacher', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Huber', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Flueck', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Hasler', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philipp M', 'Initials': 'PM', 'LastName': 'Scheiwiller', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'Sleep Disorders Center, Department of Respiratory Medicine, University Hospital of Zurich, Zurich, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7940']
1115,32564236,Does prehabilitation modify muscle mass in patients with rectal cancer undergoing neoadjuvant therapy? A subanalysis from the REx randomised controlled trial.,"BACKGROUND


Patients with rectal cancer who present with sarcopenia (low muscle mass) are at significantly greater risk of postoperative complications and reduction in disease-free survival. We performed a subanalysis of a randomised controlled study [the REx trial; www.isrctn.com ; 62859294] to assess the potential of prehabilitation to modify muscle mass in patients having neoadjuvant chemoradiotherapy (NACRT).
METHODS


Patients scheduled for NACRT, then potentially curative surgery (August 2014-March 2016) had baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements). Participants were randomised to either the intervention (13-17-week telephone-guided graduated walking programme) or control group (standard care). Follow-up testing was performed 1-2 weeks before surgery.
RESULTS


The 44 patients had a mean age of 66.8 years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72%) (body mass index ≥ 25 kg/m 2 ). At baseline, 14% were sarcopenic. At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease. Conversely, 16 (67%) controls experienced a decrease in muscle mass and 8 (33%) showed an increase. An adjusted linear regression model estimated a mean treatment difference in Total Psoas Index of 40.2mm 2 /m 2  (95% CI - 3.4 to 83.7) between groups in change from baseline (p = 0.07).
CONCLUSIONS


Prehabilitation improved muscle mass in patients with rectal cancer who had NACRT. These results need to be explored in a larger trial to determine if the poorer short- and long-term patient outcomes associated with low muscle mass can be minimised by prehabilitation.",2020,"At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease.","['Patients with rectal cancer who present with sarcopenia (low muscle mass', 'patients having neoadjuvant chemoradiotherapy (NACRT', 'patients with rectal cancer who had NACRT', '44 patients had a mean age of 66.8\xa0years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72', 'patients with rectal cancer undergoing neoadjuvant therapy', 'Patients scheduled for NACRT, then potentially curative surgery (August 2014-March 2016) had']","['telephone-guided graduated walking programme) or control group (standard care', 'baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements']","['muscle mass', 'Total Psoas Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085221', 'cui_str': 'Structure of psoas muscle'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.16134,"At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease.","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Moug', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Corsebar Road, Paisley, PA2 9PN, UK. susanmoug@nhs.net.'}, {'ForeName': 'S J E', 'Initials': 'SJE', 'LastName': 'Barry', 'Affiliation': 'Department of Mathematics and Statistics, Strathclyde University, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maguire', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Johns', 'Affiliation': 'Western General Hospital, Crewe Road South, Edinburgh, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dolan', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R J C', 'Initials': 'RJC', 'LastName': 'Steele', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buchan', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Paisley, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mackay', 'Affiliation': 'Department of Surgery, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Division of Cancer Research, Ninewells Medical School, Dundee, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Institute of Sport, Physical Education and Health Sciences, Moray House School of Education, Edinburgh, UK.'}]",Techniques in coloproctology,['10.1007/s10151-020-02262-1']
1116,32569082,Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain? A randomized controlled trial.,"Aerobic exercise is believed to be an effective chronic low back pain (CLBP) intervention, although its mechanisms remain largely untested. This study evaluated whether endogenous opioid (EO) mechanisms contributed to the analgesic effects of an aerobic exercise intervention for CLBP. Individuals with CLBP were randomized to a 6-week, 18-session aerobic exercise intervention (n = 38) or usual activity control (n = 44). Before and after the intervention, participants underwent separate laboratory sessions to assess responses to evoked heat pain after receiving saline placebo or intravenous naloxone (opioid antagonist) in a double-blinded, crossover fashion. Chronic pain intensity and interference were assessed before and after the intervention. Endogenous opioid analgesia was indexed by naloxone-placebo condition differences in evoked pain responses (blockade effects). Relative to controls, exercise participants reported significantly greater pre-post intervention decreases in chronic pain intensity and interference (Ps < 0.04) and larger reductions in placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total). At the group level, EO analgesia (MPQ-Total blockade effects) increased significantly pre-post intervention only among female exercisers (P = 0.03). Dose-response effects were suggested by a significant positive association in the exercise group between exercise intensity (based on meeting heart rate targets) and EO increases (MPQ-Present Pain Intensity; P = 0.04). Enhanced EO analgesia (MPQ-Total) was associated with a significantly greater improvement in average chronic pain intensity (P = 0.009). Aerobic exercise training in the absence of other interventions appears effective for CLBP management. Aerobic exercise-related enhancements in endogenous pain inhibition, in part EO-related, likely contribute to these benefits.",2020,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,['Individuals with CLBP'],"['aerobic exercise intervention', 'naloxone-placebo', 'aerobic exercise training', '18-session aerobic exercise intervention', 'naloxone (opioid antagonist', 'Aerobic exercise', 'endogenous opioid (EO', 'Aerobic exercise training', 'usual activity control', 'saline placebo']","['chronic pain intensity and interference', 'evoked pain responses', 'Chronic pain intensity and interference', 'EO analgesia (MPQ-Total blockade effects', 'placebo condition evoked pain responsiveness (McGill Pain Questionnaire-Short Form [MPQ]-Total', 'Enhanced EO analgesia (MPQ-Total', 'EO analgesia', 'average chronic pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0205752', 'cui_str': 'Endogenous Opiates'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",44.0,0.37122,Enhanced EO analgesia (MPQ-Total) was associated with significantly greater improvement in average chronic pain intensity (p = .009).,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, United States.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Koltyn', 'Affiliation': 'Department of Kinesiology, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Department of Anesthesiology, Rush University, Chicago, IL, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Yung Hsuan', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, IL, United States.'}, {'ForeName': 'Dima', 'Initials': 'D', 'LastName': 'Quʼd', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, United States.'}]",Pain,['10.1097/j.pain.0000000000001969']
1117,32569087,"Factors with impact on magnitude of the placebo response in randomized, controlled, cross-over trials in peripheral neuropathic pain.","The presence and magnitude of placebo responses is important for the outcome in clinical trials of analgesics. This explorative study aimed at identifying patients and trial-specific factors with impact on this response in randomized, controlled, cross-over trials in peripheral neuropathic pain. Data were derived from 7 trials and included observations on pinprick hyperalgesia, allodynia, and pain on repetitive stimulation. The studies were all performed by the same collaboration group in Denmark. Pain was rated daily using numeric 0 to 10 point rating scales (NRS) and placebo response was calculated as the difference in weekly average or median numeric rating scale from baseline to the last week of treatment. A clinically meaningful placebo response was defined as more than 30% reduction of pain on placebo. In 318 individual observations, the response was on average small (0.17 points, range -4.5 to 6). There was no significant impact on size of placebo response of trial-specific factors such as treatment sequence and chance of having placebo treatment in each period or of the patient-specific factors age, sensory signs, and pain symptoms. The findings were similar in patients having placebo in the first treatment period. There was no marked difference between patients with (n = 43) and without (n = 275) a clinically meaningful placebo response with respect to the patient-specific factors including frequency of sensory signs and symptoms. In conclusion, this study on cross-over trials in peripheral neuropathic pain found no robust impact of trial and patient-specific factors on the placebo response.",2020,"There was no significant impact on size of placebo response of trial specific factors such as treatment sequence and chance of having placebo treatment in each period or of the patient specific factors age, sensory signs and pain symptoms.",['peripheral neuropathic pain'],['placebo'],"['size of placebo response', 'Pain was rated daily using numeric 0-10 point rating scales (NRS) and placebo response', 'pain', 'pin-prick hyperalgesia, allodynia, and pain on repetitive stimulation']","[{'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",,0.400856,"There was no significant impact on size of placebo response of trial specific factors such as treatment sequence and chance of having placebo treatment in each period or of the patient specific factors age, sensory signs and pain symptoms.","[{'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Gillving', 'Affiliation': 'Department of Neurology and Neurology Research Unit, University of Southern Denmark, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Demant', 'Affiliation': 'Department of Neurology and Neurology Research Unit, University of Southern Denmark, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lund', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jakob V', 'Initials': 'JV', 'LastName': 'Holbech', 'Affiliation': 'Department of Neurology and Neurology Research Unit, University of Southern Denmark, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Otto', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Troels S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Flemming W', 'Initials': 'FW', 'LastName': 'Bach', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Nanna B', 'Initials': 'NB', 'LastName': 'Finnerup', 'Affiliation': 'Department of Clinical Medicine, Danish Pain Research Center, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Søren H', 'Initials': 'SH', 'LastName': 'Sindrup', 'Affiliation': 'Department of Neurology and Neurology Research Unit, University of Southern Denmark, Odense University Hospital, Odense, Denmark.'}]",Pain,['10.1097/j.pain.0000000000001964']
1118,32571537,Enhanced recovery after surgery for the treatment of congenital duodenal obstruction.,"BACKGROUND


Enhanced recovery after surgery (ERAS) has been widely used in adult surgery. However, ERAS has not been reported in neonatal surgery. The present prospective study explored the application value of ERAS in treating congenital duodenal obstruction (CDO).
METHODS


A total of 68 cases of CDO were collected from October 1, 2017 to July 31, 2019. We divided patients with a prenatal diagnosis of congenital duodenal obstruction into the ERAS group and those who were diagnosed the disease after birth into the control group. The ERAS group adopted ERAS-related measures, and the control group followed the usual measures. The study compared the differences in the gestational age, birth weight, length of hospital stay (LOS), complications, feeding intolerance, and weight one month after surgery between the two groups.
RESULTS


A total of 49 patients were included in the analysis, including 23 who were allocated to the ERAS group and 26 to the control group. The LOS was 9.696±1.222 days in the ERAS group and 12.654±1.686 days in the control group, resulting in a significantly shorter LOS in the ERAS group than in the control group (p<0.001). One month after surgery, the neonates in the ERAS group weighted significantly more than those in the control group. No differences were observed in birth weight, gestational age, and the incidence of complications or feeding intolerance between the two groups.
CONCLUSION


In this single-center study, the implementation of neonate-specific ERAS for CDO surgery was feasible and safe and led to a shorter LOS without increasing the incidence of complications or feeding intolerance.
TYPE OF STUDY


Treatment Study LEVEL OF EVIDENCE: Level III.",2020,"No differences were observed in birth weight, gestational age, and the incidence of complications or feeding intolerance between the two groups.
","['divided patients with a prenatal diagnosis of congenital duodenal obstruction into the ERAS group and those who were diagnosed the disease after birth into the control group', 'congenital duodenal obstruction', 'congenital duodenal obstruction (CDO', 'A total of 68 cases of CDO were collected from October 1, 2017 to July 31, 2019', 'A total of 49 patients were included in the analysis, including 23 who were allocated to the ERAS group and 26 to the control group']","['surgery (ERAS', 'ERAS']","['birth weight, gestational age, and the incidence of complications or feeding intolerance', 'shorter LOS', 'gestational age, birth weight, length of hospital stay (LOS), complications, feeding intolerance, and weight one month', 'LOS']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033053', 'cui_str': 'Intrauterine Diagnosis'}, {'cui': 'C0266181', 'cui_str': 'Congenital duodenal obstruction'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4082115', 'cui_str': 'One month'}]",49.0,0.0265272,"No differences were observed in birth weight, gestational age, and the incidence of complications or feeding intolerance between the two groups.
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Li-Ke', 'Initials': 'LK', 'LastName': 'Yuan', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Jia-Ying', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Wen-Yi', 'Initials': 'WY', 'LastName': 'Yang', 'Affiliation': 'Reproductive Health and Infertility Center, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Xiao-Chun', 'Initials': 'XC', 'LastName': 'Zhu', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Su-Yan', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Hui-Yang', 'Initials': 'HY', 'LastName': 'Ding', 'Affiliation': 'Department of Neonatal Surgery, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Mu-Dan', 'Initials': 'MD', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Guangdong Women and Children Hospital, Guangzhou, China.'}, {'ForeName': 'Shang-Jie', 'Initials': 'SJ', 'LastName': 'Xiao', 'Affiliation': ""Guangdong Women and Children's Hospital, Guangzhou Medical University. Electronic address: drsiow@163.com.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.04.015']
1119,32544067,The effect of hole size on failure loads of the distal humerus fenestration in Outerbridge-Kashiwagi arthroplasty: A biomechanical study.,"OBJECTIVE


The aim of this study was to biomechanically assess the effect of humeral-fenestration size in the Outerbridge-Kashiwagi arthroplasty on the ultimate failure load of the distal humerus in a synthetic bone model.
METHODS


We biomechanically tested the influence of different humeral-fenestration sizes on the failure load of the distal humerus in Outerbridge-Kashiwagi arthroplasty. A total of 50 synthetic humerus models were divided into 5 groups based on the fenestration size: 10 mm, 12 mm, 15 mm, 18 mm, and 20 mm. All the samples were randomly assigned to receive either axial or anteroposterior (AP) loading and then loaded to failure at a rate of 2 mm/min on a material testing machine. The data regarding ultimate failure loads under the axial and AP loading were analyzed.
RESULTS


Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups. Under the axial loading, the mean ultimate failure load of the 10 mm group was significantly greater than that of the 15 mm, 18 mm, and 20 mm groups. Additionally, the ultimate failure load of the 20 mm group was significantly lower than that of the 12 mm, 15 mm, and 18 mm groups.
CONCLUSION


The distal humeral fenestrations with a size greater than 18 mm may offer poor biomechanical properties in the Outerbridge-Kashiwagi ulnohumeral arthroplasty.",2020,"Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups.","['50 synthetic humerus models', 'Outerbridge-Kashiwagi arthroplasty']","['hole size', 'axial or anteroposterior (AP) loading']","['mean ultimate failure loads', 'ultimate failure load']","[{'cui': 'C0020164', 'cui_str': 'Bone structure of humerus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",50.0,0.0468683,"Under the AP loading, the mean ultimate failure loads of the 18 mm and 20 mm groups were lower than those of the other groups.","[{'ForeName': 'Chih-Kai', 'Initials': 'CK', 'LastName': 'Hong', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kai-Lan', 'Initials': 'KL', 'LastName': 'Hsu', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan;Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Fa-Chuan', 'Initials': 'FC', 'LastName': 'Kuan', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan;Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Chi-Hsiu', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, School of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ping-Hui', 'Initials': 'PH', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Chi-Mei Medical Center, Tainan, Taiwan.'}, {'ForeName': 'Wei-Ren', 'Initials': 'WR', 'LastName': 'Su', 'Affiliation': 'Department of Orthopaedic Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan;Skeleton Materials and Bio-compatibility Core Lab, Research Center of Clinical Medicine, National Cheng Kung University Hospital, College of Medicine,National Cheng Kung University, Tainan, Taiwan.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.03.59']
1120,32544109,Effects of Dry Needling Technique Into Trigger Points of the Sternocleidomastoid Muscle in Migraine Headache: A Randomized Controlled Trial.,"OBJECTIVE


The study aimed to investigate the effect of dry needling into trigger points of the sternocleidomastoid muscle in migraine headache patients.
DESIGN


Forty subjects with a migraine headache, originating from myofacial trigger points into the sternocleidomastoid muscle (20 subjects in dry needling group and 20 subjects in control group) volunteered to participate in this study. The subjects in the treatment group received three sessions of dry needling in the myofascial trigger point region. Headache frequency, headache intensity, headache duration, drug consumption, muscle thickness, pressure pain threshold, and cervical range of motion were assessed before, immediately after intervention, and at 1-mo follow-up period. In addition, this article was extracted from Iranian Register of Clinical Trials Number IRCT20171219037956N1.
RESULTS


The experimental group showed significant reduction in the headache parameters immediately after the intervention and at 1-mo follow-up, as compared with the control group. The pressure pain threshold of sternocleidomastoid muscle, cervical range of motion, and muscle thickness significantly increased in the dry needling group in comparison with the control group (P < 0.001).
CONCLUSIONS


The application of dry needling technique caused an improvement in symptoms of migraine patients. Therefore, this technique may be prescribed for treating migraine patients with myofacial trigger points in the sternocleidomastoid muscle.",2020,"The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
","['migraine headache patients', 'Forty subjects with a migraine headache, originating from myofacial trigger points into the sternocleidomastoid (SCM) muscle (20 subjects in DN group and 20 subjects in control group) volunteered to participate in this study', 'migraine headache', 'migraine patients']","['dry needling (DN', 'dry needling technique', 'dry needling']","['headache parameters', 'Headache frequency, headache intensity, headache duration, drug consumption, muscle thickness, pressure pain threshold (PPT), and cervical range of motion', 'PPT of SCM muscle, cervical range of motion, and muscle thickness']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}]",40.0,0.0137744,"The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
","[{'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'From the Physiotherapy Department, Social Welfare and Rehabilitation Sciences University, Tehran, Iran (TR); Physiotherapy Department and Research Center on Aging, Social Welfare and Rehabilitation Sciences University, Tehran, Iran (ZM); Physiotherapy Department, North Georgia University, Dahlonega, Georgia (MRN); Social Determinants of Health Research Center, Social Welfare and Rehabilitation Sciences University, Tehran, Iran (MN); and Clinical Sciences Department & Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran (FS).'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Noroozi', 'Affiliation': ''}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sajedi', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001504']
1121,32557923,Splenic Switch-Off for Determining the Optimal Dosage for Adenosine Stress Cardiac MR in Terms of Stress Effectiveness and Patient Safety.,"BACKGROUND


Adenosine stress MRI is well established for the evaluation of known and suspected coronary artery disease. However, a proportion of patients might be ""under-stressed"" using the standard adenosine dose.
PURPOSE


To compare three different adenosine dosages for stress MRI in terms of stress adequacy based on splenic switch-off (SSO) and limiting side effects.
STUDY TYPE


Prospective.
POPULATION


In all, 100 patients were randomized in group 1 (33 pts), group 2 (34 pts), and group 3 (33 pts), receiving dosages of 140 μg/kg/min, 175 μg/kg/min, or 210 μg/kg/min, respectively. SSO was evaluated visually and quantitatively.
SEQUENCE


Stress perfusion was performed using a 1.5T scanner in three short axes using a standard single-shot, saturation recovery gradient-echo sequence.
ASSESSMENT


Three blinded experienced operators evaluated SSO on stress and rest perfusion acquisitions in the three groups. The signal intensity of the spleen and myocardium and the presence of inducible ischemia and late gadolinium enhancement were assessed.
STATISTICAL ANALYSIS


T-test, analysis of variance (ANOVA), chi-squared test, and Pearson's correlation coefficient.
RESULTS


SSO was present more frequently in patients receiving 175 μg/kg/min and 210 μg/kg/min (31/33 [94%] and 27/29 [93%], respectively) compared to those receiving the standard dose (19/33 [58%], P < 0.05). A positive stress result was noted in 3/33 (9%) patients receiving 140 μg/kg/min vs. 9/33 (27%) patients receiving 175 μg/kg/min and 10/31 (33%) patients receiving 210 μg/kg/min (P < 0.05 for all, P < 0.05 for group 1 vs. groups 2, 3). The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05). No adverse events during scanning were noted in groups 1 and 2, whereas in group 3 four examinations were stopped due to severe dyspnea (n = 2) and AV-blockage (n = 2).
DATA CONCLUSION


A dosage of 175 μg/kg/min adenosine results in a higher proportion of SSO, which may be an indirect marker of adequate coronary vasodilatation and simultaneously offers similar safety compared to the standard 140 μg/kg/min dosage.
LEVEL OF EVIDENCE


1 TECHNICAL EFFICACY STAGE: 2 J. MAGN. RESON. IMAGING 2020;52:1732-1742.",2020,"The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05).",['100 patients'],[],"['SSO', 'SSO on stress and rest perfusion acquisitions', 'splenic signal intensity', 'severe dyspnea', 'adverse events', 'signal intensity of the spleen and myocardium and the presence of inducible ischemia and late gadolinium enhancement']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0424598', 'cui_str': 'Illness: Switched off'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",100.0,0.060122,"The relative decrease of splenic signal intensity at hyperemia vs. baseline was significantly lower in group 1 compared to groups 2 and 3 (-33% vs. -54%, -56%, respectively; P < 0.05).","[{'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Giusca', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hofmann', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Hagstotz', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Forschner', 'Affiliation': 'Radiology Practice, Weinheim, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schueler', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nunninger', 'Affiliation': 'Radiology Practice, Weinheim, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kelle', 'Affiliation': 'Department of Internal Medicine/Cardiology, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'Grigorios', 'Initials': 'G', 'LastName': 'Korosoglou', 'Affiliation': 'Department of Cardiology Angiology and Pneumology, GRN Hospital Weinheim, Weinheim, Germany.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27248']
1122,32553191,"Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.","BACKGROUND


Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery.
METHODS


This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560.
FINDINGS


Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00).
INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries.
FUNDING


Keio University and Ohyama Health Foundation.",2020,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","['Patients aged 20 years or older who underwent elective clean-contaminated wound surgery', 'Between June 10, 2018, and April 18, 2019', 'patients who undergo clean-contaminated surgeries', '587 patients were eligible and 294 received', 'clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals', 'surgical site infections after clean-contaminated surgery', '0·48', '883 patients were assessed for eligibility']","['surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery', 'olanexidine and 293 received aqueous povidone-iodine before surgery', 'chlorhexidine-alcohol and povidone-iodine', 'aqueous olanexidine and aqueous povidone-iodine', 'Olanexidine', 'olanexidine', 'Aqueous olanexidine versus aqueous povidone-iodine', 'povidone-iodine', 'surgical skin antisepsis', 'aqueous povidone-iodine']","['SSI rate', 'adverse skin reactions', '30-day SSI assessed in the intention-to-treat population', 'bactericidal activity', 'efficacy and safety', '30-day SSI', 'occurrence of overall SSI and superficial incisional SSI', 'risk ratio [RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0755906', 'cui_str': 'olanexidine'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3662309', 'cui_str': 'Superficial incisional surgical site infection'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",883.0,0.17549,"INTERPRETATION


Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Obara', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan. Electronic address: obara.z3@keio.jp.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Okabayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koki', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Sekimoto', 'Affiliation': 'Department of Surgery, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Surgery, Kawasaki Municipal Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30225-5']
1123,32551725,Patterns of change and their relationship to outcome and follow-up in group and individual psychotherapy for depression.,"OBJECTIVE


The study explored the presence of different patterns of change in a sample of patients who received cognitive therapy for depression sequentially in two different formats: group and individual. Our hypothesis was that patients' baseline characteristics (e.g., symptom severity, self-esteem) would discriminate patterns of response to group and individual therapy.
METHOD


108 adults who met criteria for depression and completed the treatments included in a randomized controlled trial (RCT) were assessed with the Beck Depression Inventory-II (BDI-II), the Clinical Outcome in Routine Evaluation-Short Form B (CORE-SFB), the Global Assessment of Functioning (GAF), and the repertory grid technique. Growth mixture modeling was carried out to identify the patterns of change. Mixed linear models and repeated measures analysis of variance were performed to compare patients' characteristics in each pattern. Multinomial logistic regression was used to compute predictive models for the patterns from patients' characteristics. Finally, hierarchical linear regression was used to establish the power of each pattern to predict treatment outcome.
RESULTS


A 3-class solution was obtained: group therapy improvers, individual therapy improvers, and nonimprovers. Group therapy improvers started therapy with less severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self than the other groups. Individual therapy improvers and nonimprovers presented similar characteristics at baseline. However, a significant proportion of nonimprovers presented a concurrent diagnosis of fibromyalgia.
CONCLUSION


The greater the impairment that patients present at baseline, the more likely they are to benefit from individual therapy after group therapy. A diagnosis of fibromyalgia can be considered a risk factor for therapy failure in the treatment of depression. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Group therapy improvers started therapy with less severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self than the other groups.",['108 adults who met criteria for depression and completed the treatments'],"['Routine Evaluation-Short Form B (CORE-SFB', 'cognitive therapy']","['severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self', 'Beck Depression Inventory-II (BDI-II']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",108.0,0.0521554,"Group therapy improvers started therapy with less severe levels of depression and psychological distress, higher functioning and self-esteem, lower perceived social isolation, and lower dilemmatic construction of the self than the other groups.","[{'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Moggia', 'Affiliation': 'Department of Clinical Psychology and Psychobiology.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Arndt', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Feixas', 'Affiliation': 'Department of Clinical Psychology and Psychobiology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000562']
1124,32568433,Alterations in Functional Connectivity During Different Phases of the Triggered Migraine Attack.,"OBJECTIVE


To understand the changes in functional connectivity between brain areas of potential importance in migraine during different phases of the attack.
BACKGROUND


Migraine is a symptomatically heterogeneous disorder. Understanding the possible changes in brain function and, therefore, neurobiology during different phases of the migraine attack is important in developing disease biomarkers and advancing therapeutics.
DESIGN


Randomized, double-blind, placebo-controlled, multi-visit experimental study.
METHODS


Subjects aged 18-50 years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n = 53). Consented subjects were randomized to a 0.5 µg/kg/min nitroglycerin infusion or to placebo over 20 minutes across different study visits, during the period February 2015-July 2017.* All subjects were exposed to a nitroglycerin infusion at least on 1 occasion at screening.** For those subjects who consented to participate in imaging visits (n = 25), structural T1, T2 and FLAIR sequences and resting state blood oxygen level dependant contrast (rsBOLD) time series, using a multiecho EPI sequence, were conducted over 30-40 minutes at baseline and rsBOLD during premonitory symptoms and migraine headache on a 3T General Electric MR750 MRI scanner. For the placebo visit, the imaging was conducted at the same times following infusion in the absence of symptoms.
RESULTS


Montreal Neurological Institute (MNI) coordinates were used to characterize identified brain areas of connectivity change. Using repeated measures ANOVA models with time (visit number) and trigger substance (nitroglycerin/placebo) as factors, significant positive functional coupling was found between the thalami bilaterally and the right precuneus and cuneus regions during the nitroglycerin-triggered premonitory phase (T = 3.23, peak connectivity change at [-6, -68, 40] for left thalamus, P = 0.012 and [-4, -68, 40] for right thalamus, P = 0.019). The nitroglycerin-triggered premonitory phase was associated with a change in the direction of connectivity from positive to negative between the pons and the limbic lobe (T = 3.47, peak connectivity change at [2, 8, 50], P < 0.001). The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = 0.007).
CONCLUSIONS


Understanding the functional reorganization between subcortical and cortical brain areas in different phases of the migraine attack provides novel insights into the abnormal sensory processing and integration during migraine, as well as functional correlation with clinical symptoms displayed during each phase. [*Correction added on July 22, 2020 after first online publication: This sentence was revised from, ""Consented subjects had a 0.5 μg/kg/min nitroglycerin infusion…"".] [**Correction added on July 22, 2020 after first online publication: This sentence was revised from, ""… at least on 1 occasion at screening.""].",2020,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007).
","['Montreal Neurological Institute (MNI', 'Subjects aged 18-50\xa0years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n\xa0=\xa053']","['substance (nitroglycerin/placebo', 'nitroglycerin infusion or to placebo', 'nitroglycerin', 'placebo']","['Functional Connectivity', 'positive functional coupling', 'structural T1, T2 and FLAIR sequences and resting state blood oxygen level']","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.063712,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007).
","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Headache,['10.1111/head.13865']
1125,32568452,"Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced vomiting in children: An open-label, randomized phase 3 trial.","BACKGROUND


Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine and metoclopramide are two drugs recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
PROCEDURE


Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy were randomly assigned to the metoclopramide or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or metoclopramide for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.
RESULTS


Eighty patients were analyzed (39 in the olanzapine arm and 41 in the metoclopramide arm). CR rates were significantly higher in the olanzapine arm compared with the metoclopramide arm for vomiting (72% vs 39%, P = 0.003) and nausea (59% vs 34%, P = 0.026). Seven patients in the metoclopramide arm crossed over to the olanzapine arm and none crossed over in the olanzapine arm (P < 0.001). The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01). Hyperglycemia and drowsiness were more commonly seen in the olanzapine arm.
CONCLUSION


Olanzapine is superior to metoclopramide for the treatment of breakthrough CIV in children. Drowsiness and hyperglycemia need to be monitored closely in children receiving olanzapine for breakthrough CIV.",2020,The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01).,"['Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy', 'Eighty patients were analyzed (39 in the olanzapine arm and 41 in the metoclopramide arm', 'patients receiving', 'children']","['olanzapine and metoclopramide', 'olanzapine', 'Olanzapine', 'metoclopramide', 'Olanzapine and metoclopramide', 'metoclopramide or olanzapine', 'olanzapine or metoclopramide']","['CR rates', 'Hyperglycemia and drowsiness', 'complete response (CR) rates', 'Drowsiness and hyperglycemia', 'mean nausea score', 'vomiting (CIV', 'CR rates for nausea and toxicities', 'vomiting', 'safety and efficacy', 'nausea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",80.0,0.0760245,The mean nausea score in the olanzapine arm was significantly lower than the metoclopramide arm after the initiation of the rescue antiemetic (P = 0.01).,"[{'ForeName': 'Venkatraman', 'Initials': 'V', 'LastName': 'Radhakrishnan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Vishwajeeth', 'Initials': 'V', 'LastName': 'Pai', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Swaminathan', 'Initials': 'S', 'LastName': 'Rajaraman', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Trivadi', 'Initials': 'T', 'LastName': 'Ganesan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Manikandan', 'Initials': 'M', 'LastName': 'Dhanushkodi', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Jayachandran', 'Initials': 'J', 'LastName': 'Perumal Kalaiyarasi', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Arun Kumar', 'Initials': 'AK', 'LastName': 'Rajan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Gangothri', 'Initials': 'G', 'LastName': 'Selvarajan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Parathan', 'Initials': 'P', 'LastName': 'Karunakaran', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}, {'ForeName': 'Tenali G', 'Initials': 'TG', 'LastName': 'Sagar', 'Affiliation': 'Department of Medical Oncology (Pediatric Oncology Division) and Biostatistics, Cancer Institute (WIA), Adyar, Chennai, Tamilnadu, India.'}]",Pediatric blood & cancer,['10.1002/pbc.28532']
1126,32568460,Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors.,"BACKGROUND


Insomnia is common among adolescent and young adult (AYA) cancer survivors. Cognitive-behavioral therapy for insomnia (CBT-I) is considered the gold standard treatment. Standard CBT-I was designed for adults and not adapted to the unique medical, psychosocial, and developmental needs of AYA cancer survivors, which can exacerbate their insomnia. Further, the vast majority of cancer centers do not have a behavioral sleep medicine expert on staff. Our study objective was to examine the efficacy of an Internet-delivered CBT-I program that was tailored for AYA cancer survivors (NCT03279055).
PROCEDURE


Twenty-two AYA cancer survivors (mean age 20.4; range 14-25) with insomnia enrolled in an automated CBT-I program modified for AYA cancer survivors following stakeholder feedback. Participants were blood cancer (54.5%) and solid tumor (45.5%) survivors, an average of 9.7 years postdiagnosis. Sleep health, fatigue, and quality of life were assessed at baseline and at two follow up timepoints (8 and 16 weeks postbaseline).
RESULTS


Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints. However, most participants (72.7%) did not complete all of the six study sessions, with a mean completion rate of 3.2 sessions. Participants who completed at least two sessions reported better sleep (insomnia severity index total score) than those who did not.
CONCLUSIONS


An Internet-delivered insomnia intervention adapted for AYA cancer survivors was efficacious. This has important implications for access to evidence-based clinical care for this growing population. Future efforts should study stepped care models of care and ways to improve treatment adherence.",2020,"RESULTS


Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints.","['Participants were blood cancer (54.5%) and solid tumor (45.5%) survivors, an average of 9.7\xa0years postdiagnosis', 'Twenty-two AYA cancer survivors (mean age 20.4; range 14-25) with insomnia enrolled in an automated CBT-I program modified for AYA cancer survivors following stakeholder feedback', 'adolescent and young adult (AYA) cancer survivors', 'adolescent and young adult cancer survivors']","['Internet-delivered insomnia intervention', 'Cognitive-behavioral therapy']","['sleep and quality of life', 'insomnia severity, daytime sleepiness, fatigue, and quality of life', 'Sleep health, fatigue, and quality of life', 'sleep (insomnia severity index total score']","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",25.0,0.04861,"RESULTS


Significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life were reported at both follow up timepoints.","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.""}]",Pediatric blood & cancer,['10.1002/pbc.28506']
1127,32569414,Randomized Pragmatic Pilot Trial Comparing Perpendicular Thin Electrode Versus Parallel Thick Electrode Approaches for Lumbar Medial Branch Neurotomy in Facetogenic Low Back Pain.,"OBJECTIVES


Although there are different ways of performing medial branch neurotomy on facetogenic low back pain, few studies have compared clinical outcomes of a parallel technique over the medial branch vs. a perpendicular technique. We investigated differences in pain outcome with both techniques.
DESIGN


This was a prospective, pilot, randomized, pragmatic trial (double blinded in the diagnostic phase).
SETTING


A comparative pilot trial was conducted at an academic pain center.
METHODS


Patients who did not respond to conservative medications and had severe lumbar pain for more than 3 months (VAS score ≥ 65) were included. A double diagnostic block with local anesthetic and placebo was performed, double blinded. Patients who had 80% relief from the local anesthetic and no substantial relief from placebo were randomized to undergo medial branch neurotomy under fluoroscopy, placing an electrode parallel or perpendicular to the medial branch. The primary outcome was differences in the VAS score at 1, 3, and 6 months. The secondary outcomes were Oswestry Disability Index score, Roland Morris Questionnaire score, and other functional Likert scale scores.
RESULTS


Forty-three consecutive patients were randomized to parallel (n = 20) or perpendicular (n = 23) neurotomy. There were no significant differences in VAS, Oswestry Disability Index, or Roland Morris Questionnaire scores at 1, 3, or 6 months between groups. Statistically significant differences were found in the categorical analysis at 6 months in the evolution of pain, Oswestry Disability Index score, Roland Morris Questionnaire score, and some Likert scale scores in favor of the parallel group.
CONCLUSIONS


There were differences at 6 months in the categorical analysis of the evolution of pain, Oswestry Disability Index score, Roland Morris Questionnaire score, and some functional Likert scale scores, all in favor of the parallel group.",2020,"There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups.","['academic pain centre', 'Patients who had an 80% relief from the local anaesthetic and no substantial relief from', 'Forty-three consecutive patients were randomized to parallel (n=20) or perpendicular (n=23) neurotomy', 'facetogenic low back pain', 'Patients who did not respond to conservative medications and had severe lumbar pain for more than 3 months (VAS≥65) were included']","['local anaesthetic and placebo', 'medial branch neurotomy placing an electrode parallel or perpendicular to the medial branch, under fluoroscopy', 'perpendicular thin electrodes versus parallel thick electrodes approaches', 'placebo']","['Oswestry Disability Index, Roland Morris Questionnaire and other functional Likert scales', 'Visual Analogue Scale', 'evolution of pain, Oswestry, Roland Morris and some Likert scales', 'pain outcome', 'evolution of pain, Oswestry, Roland Morris and in some functional Likert scales', 'Visual Analogue Scale, Oswestry or Roland Morris']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0196558', 'cui_str': 'Incision of nerve'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0196558', 'cui_str': 'Incision of nerve'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",43.0,0.572113,"There were no significant differences in Visual Analogue Scale, Oswestry or Roland Morris at 1, 3 or 6 months between groups.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De Andrés Ares', 'Affiliation': 'Unidad del Dolor Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gilsanz', 'Affiliation': 'Unidad del Dolor Hospital Universitario La Paz, Madrid, Spain.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12928']
1128,32445498,Effect of Fremanezumab Monthly and Quarterly Doses on Efficacy Responses.,"OBJECTIVE


Exposure-response (E-R) models were developed to provide a description of the time-course of treatment effect for monthly and quarterly dosing regimens of fremanezumab.
BACKGROUND


Fremanezumab is a monoclonal antibody for preventive treatment of episodic migraine (EM) and chronic migraine (CM). In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM. Development of E-R models relating individual-specific measures of drug exposure to clinical endpoints provides a more granular understanding of the expected effects of different doses on therapeutic outcomes by accounting for variability in pharmacokinetic (PK) properties.
METHODS


Data from 2 phase 2b and 2 phase 3 studies of adults with EM or CM were used. Individual exposures were calculated from a population PK model and related to monthly migraine days in EM and moderate-severe (M/S) headache days in CM. Model-based stochastic simulations were performed to compare predicted responses for the various treatment regimens.
RESULTS


The effect of average fremanezumab concentration compared to placebo on the reduction in migraine days and M/S headache days was predicted by the models to be similar for 225 mg monthly and 675 mg once quarterly over time for both EM and CM patients. Both regimens were associated with better response than placebo. A similar percent of EM and CM responders was predicted across the range of observed body weights.
CONCLUSIONS


Exposure-response evaluations showed that both monthly (225 mg) and quarterly (675 mg) fremanezumab dosing regimens were appropriate in achieving clinical benefit in adult patients with EM or CM.",2020,"In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM.","['adult patients with EM or CM', 'Data from 2 phase 2b and 2 phase 3 studies of adults with EM or CM were used']","['Fremanezumab', 'fremanezumab', 'placebo']","['migraine days and M/S headache days', 'Efficacy Responses', 'migraine and headache days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0603915,"In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM.","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fiedler-Kelly', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Passarell', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ludwig', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Micha', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Cohen-Barak', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Netanya, Israel.'}]",Headache,['10.1111/head.13845']
1129,32557384,The Influence of Laparoscopic Sleeve Gastrectomy on Body Composition and Fat Distribution in Obese Caucasian Men and Women.,"BACKGROUND


The aim of the study was to assess changes in body composition in patients subjected to laparoscopic sleeve gastrectomy (LSG).
METHODS


Changes in body composition following LSG were determined in a group of 155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA). Whole body fat mass (FM) and lean body mass (LBM) were determined, and abdominal fat mass (AbdF) was assessed within the region extending from the top of the pubic bone up to the line between 12th thoracic and 1st lumbar vertebras.
RESULTS


Over the period of 12 months following LSG, body mass index decreased by 28.2 ± 9.0% (p < 0.001). The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001). AbdF decreased from 13.2 ± 3.1 to 8.2 ± 2.7 kg (p < 0.001), but abdominal fat to total fat mass ratio increased from 24.9 ± 4.7 to 28.0 ± 5.8% (p < 0.001). The loss of AbdF was more pronounced in men than in women. The rate of FM loss was attenuated with patients' age.
CONCLUSIONS


Over the period of 12 months following LSG, the reduction of FM was more than twice as much as decrease of LBM. The loss of AbdF was slower than a loss of peripheral subcutaneous fat.",2020,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"['patients subjected to', '155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA', 'Obese Caucasian Men and Women']","['Laparoscopic Sleeve Gastrectomy', 'laparoscopic sleeve gastrectomy (LSG']","['rate of FM loss', 'FM', 'body mass index', 'reduction of body weight', 'body composition', 'abdominal fat to total fat mass ratio', 'LBM', 'loss of AbdF', 'Body Composition and Fat Distribution', 'Whole body fat mass (FM) and lean body mass (LBM', 'reduction of FM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",155.0,0.0416692,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Tałałaj', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland. marektalalaj@op.pl.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Bogołowska-Stieblich', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wąsowski', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Binda', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Jaworski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wrzosek', 'Affiliation': 'Department of Biochemistry and Pharmacogenomics, Faculty of Pharmacy, Medical University of Warsaw, Banacha 1, 02-097, Warsaw, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Tarnowski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}]",Obesity surgery,['10.1007/s11695-020-04766-z']
1130,32556601,Effects of spinal anesthesia and sedation with dexmedetomidine or propofol on cerebral regional oxygen saturation and systemic oxygenation a period after spinal injection.,"PURPOSE


To evaluate changes in cerebral regional oxygen saturation (rSO 2 ) after spinal anesthesia and compare the changes in rSO 2  and systemic oxygenation between dexmedetomidine sedation and propofol sedation.
METHODS


Thirty-six patients scheduled to undergo transurethral surgery under spinal anesthesia were randomly assigned to the dexmedetomidine (n = 18) and propofol groups (n = 18). We used near-infrared spectroscopy sensors to measure rSO 2 , and obtained data from each side were averaged. After oxygen insufflation, baseline measurements of mean arterial blood pressure (MAP), heart rate, rSO 2 , pulse oximetry saturation (SpO 2 ), bispectral index, and body temperature were made. After spinal anesthesia, we measured these parameters every 5 min. Twenty minutes after spinal injection, dexmedetomidine or propofol administration was started. We measured each parameter at 10, 25, and 40 min after the administration of dexmedetomidine or propofol.
RESULTS


The baseline rSO 2  in the dexmedetomidine group was 71.3 ± 7.3%, and that in the propofol group was 71.8 ± 5.6%. After spinal anesthesia, rSO 2  in both groups decreased significantly (dexmedetomidine group: 65.4 ± 6.9%; propofol group: 64.3 ± 7.4%). After administering sedatives, rSO 2  was equivalent after spinal anesthesia. rSO 2  was comparable between the two groups. MAP and SpO 2  were significantly higher in the dexmedetomidine group than in the propofol group.
CONCLUSION


Spinal anesthesia decreased rSO 2 ; however, the decline was not severe. Dexmedetomidine and propofol did not compromise cerebral oxygenation under spinal anesthesia. Nevertheless, MAP and SpO 2  were more stable in dexmedetomidine sedation than in propofol sedation. Dexmedetomidine may be suitable for spinal anesthesia.",2020,"After spinal anesthesia, rSO 2  in both groups decreased significantly (dexmedetomidine group: 65.4 ± 6.9%; propofol group: 64.3 ± 7.4%).",['Thirty-six patients scheduled to undergo transurethral surgery under spinal anesthesia'],"['Dexmedetomidine and propofol', 'Dexmedetomidine', 'dexmedetomidine sedation and propofol sedation', 'dexmedetomidine or propofol', 'spinal anesthesia and sedation with dexmedetomidine or propofol', 'propofol', 'dexmedetomidine']","['cerebral regional oxygen saturation and systemic oxygenation', 'MAP and SpO 2', 'cerebral regional oxygen saturation', 'mean arterial blood pressure (MAP), heart rate, rSO 2 , pulse oximetry saturation (SpO 2 ), bispectral index, and body temperature']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",36.0,0.0231253,"After spinal anesthesia, rSO 2  in both groups decreased significantly (dexmedetomidine group: 65.4 ± 6.9%; propofol group: 64.3 ± 7.4%).","[{'ForeName': 'Yasutomo', 'Initials': 'Y', 'LastName': 'Kumakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan. ykurakuma@yamanashi.ac.jp.'}, {'ForeName': 'Tadahiko', 'Initials': 'T', 'LastName': 'Ishiyama', 'Affiliation': 'Surgical Center, University of Yamanashi Hospital, University of Yamanashi, Yamanashi, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Iijima', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsukawa', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, University of Yamanashi, 1110 Shimokato, Chuo, Yamanashi, 409-3898, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02816-5']
1131,32568065,Sodium bicarbonate to improve physical function in patients over 60 years with advanced chronic kidney disease: the BiCARB RCT.,"BACKGROUND


Advanced chronic kidney disease is common in older people and is frequently accompanied by metabolic acidosis. Oral sodium bicarbonate is used to treat this acidosis, but evidence is lacking on whether or not this provides a net gain in health or quality of life for older people.
OBJECTIVES


The objectives were to determine whether or not oral bicarbonate therapy improves physical function, quality of life, markers of renal function, bone turnover and vascular health compared with placebo in older people with chronic kidney disease and mild acidosis; to assess the safety of oral bicarbonate; and to establish whether or not oral bicarbonate therapy is cost-effective in this setting.
DESIGN


A parallel-group, double-blind, placebo-controlled randomised trial.
SETTING


The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals.
PARTICIPANTS


Participants were adults aged ≥ 60 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of < 22 mmol/l.
INTERVENTIONS


Eligible participants were randomised 1 : 1 to oral sodium bicarbonate or matching placebo. Dosing started at 500 mg three times daily, increasing to 1 g three times daily if the serum bicarbonate concentration was < 22 mmol/l at 3 months.
MAIN OUTCOME MEASURES


The primary outcome was the between-group difference in the Short Physical Performance Battery score at 12 months, adjusted for baseline. Other outcome measures included generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide. All adverse events were recorded, including commencement of renal replacement therapy. For the health economic analysis, the incremental cost per quality-adjusted life-year was the main outcome.
RESULTS


In total, 300 participants were randomised, 152 to bicarbonate and 148 to placebo. The mean age of participants was 74 years and 86 (29%) were female. Adherence to study medication was 73% in both groups. A total of 220 (73%) participants were assessed at the 12-month visit. No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points;  p  = 0.15). No significant treatment benefit was seen for any of the secondary outcomes. Adverse events were more frequent in the bicarbonate arm (457 vs. 400). Time to commencement of renal replacement therapy was similar in both groups (hazard ratio 1.22, 95% confidence interval 0.74 to 2.02;  p  = 0.43). Health economic analysis showed higher costs and lower quality of life in the bicarbonate arm at 1 year, with additional costs of £564 (95% confidence interval £88 to £1154) and a quality-adjusted life-year difference of -0.05 (95% confidence interval -0.08 to -0.01); placebo dominated bicarbonate under all sensitivity analyses for incremental cost-effectiveness.
LIMITATIONS


The trial population was predominantly white and male, limiting generalisability. The increment in serum bicarbonate concentrations achieved was small and a benefit from larger doses of bicarbonate cannot be excluded.
CONCLUSIONS


Oral sodium bicarbonate did not improve a range of health measures in people aged ≥ 60 years with chronic kidney disease category 4 or 5 and mild acidosis, and is unlikely to be cost-effective for use in the NHS in this patient group. Once other current trials of bicarbonate therapy in chronic kidney disease are complete, an individual participant meta-analysis would be helpful to determine which subgroups, if any, are more likely to benefit and which treatment regimens are more beneficial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN09486651 and EudraCT 2011-005271-16. The systematic review is registered as PROSPERO CRD42018112908.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 27. See the NIHR Journals Library website for further project information.",2020,"No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points;  p  = 0.15).","['Participants were adults aged ≥\u200960 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of <\u200922\u2009mmol/l', 'older people with chronic kidney disease and mild acidosis', 'The mean age of participants was 74 years and 86 (29%) were female', '300 participants were randomised, 152 to', 'patients over 60 years with advanced chronic kidney disease', 'people aged ≥\u200960 years with chronic kidney disease category 4 or 5 and mild acidosis', 'The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals']","['Sodium bicarbonate', 'placebo dominated bicarbonate', 'bicarbonate', 'oral sodium bicarbonate or matching placebo', 'bicarbonate therapy', 'Oral sodium bicarbonate', 'placebo']","['Time to commencement of renal replacement therapy', 'higher costs and lower quality of life', 'physical function', 'Adverse events', 'range of health measures', 'Short Physical Performance Battery score', 'serum bicarbonate concentration', 'generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide', 'physical function, quality of life, markers of renal function, bone turnover and vascular health', 'serum bicarbonate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",300.0,0.463179,"No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points;  p  = 0.15).","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation, Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Band', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Huey', 'Initials': 'H', 'LastName': 'Chong', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.'}, {'ForeName': 'Geeta', 'Initials': 'G', 'LastName': 'Hampson', 'Affiliation': ""Department of Clinical Chemistry and Metabolic Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'May Khei', 'Initials': 'MK', 'LastName': 'Hu', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Lamb', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'The Immunoassay Biomarker Core Laboratory, University of Dundee, Dundee, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McNamee', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Plews', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rauchhaus', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'Ageing Clinical and Experimental Research, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sumukadas', 'Affiliation': 'Department of Medicine for the Elderly, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Warwick', 'Affiliation': 'John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Avenell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24270']
1132,32565318,Impact of Sequencing of Androgen Suppression and Radiation Therapy on Testosterone Recovery in Localized Prostate Cancer.,"PURPOSE


We performed a secondary analysis of a phase 3 randomized trial to determine the influence of sequencing of radiation therapy and androgen deprivation therapy (ADT) on posttreatment testosterone recovery and implications of testosterone recovery on subsequent relapse.
METHODS AND MATERIALS


Patients with localized prostate cancer with Gleason score ≤7, clinical stage T1b to T3a, and prostate-specific antigen <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate radiation therapy (NHT arm) or concurrent and adjuvant ADT for 6 months starting simultaneously with radiation therapy (CAHT arm). Full testosterone recovery (FTR) was defined as recovery of testosterone to >10.5 nmol/L in patients with baseline ≥10.5 nmol/L or to baseline level in patients with baseline <10.5 nmol/L. Restricted mean survival time (RMST) since ADT initiation to supracastrate testosterone level (>1.7 nmol/L), and to FTR was compared between the arms using a truncation time point of 36 months.
RESULTS


The adjusted difference in RMST to supracastrate testosterone between the CAHT and NHT arm was 1.5 months (95% confidence interval [CI], 0.5-2.5; P = .005). No difference was noted in RMST to FTR between the arms (18.7 vs 18.5 months, adjusted difference: 0.5; 95% CI, -1.4 to 2.4; P = .61). There was no evidence of heterogeneity of treatment effect (interaction P = .76) on risk of relapse over subgroups stratified by testosterone recovery to supracastrate level at 15 months after start of ADT. Based on a multistate Markov model, no independent effect of time to FTR on risk of subsequent relapse was observed (adjusted hazard ratio: 1.02; 95% CI, 0.96-1.08).
CONCLUSIONS


Patients should be counseled that an additional 12 months on average is needed for FTR to occur after treatment with prostate radiation therapy and 6 months of ADT. This is independent of the sequencing of ADT and radiation therapy. Furthermore, recovery of testosterone does not appear to affect the risk of subsequent relapse.",2020,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"['Localized prostate cancer patients with Gleason', 'Localized Prostate Cancer']","['neoadjuvant and concurrent ADT', 'prostate radiotherapy (NHT arm) or concurrent and adjuvant ADT', 'Androgen Suppression and Radiotherapy', 'radiotherapy and ADT', 'prostate radiotherapy']","['RMST to FTR', 'mean survival time (RMST) since ADT initiation to supra-castrate testosterone level', 'RMST to supra-castrate testosterone', 'risk of subsequent relapse', 'risk of relapse', 'Full testosterone recovery (FTR', 'score ≤7, clinical stage T1b-T3a, and prostate-specific antigen', 'recovery of testosterone']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0475390', 'cui_str': 'Tumor stage T3a'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",,0.251948,There was no evidence of heterogeneity of treatment effect (interaction p=0.76) on risk of relapse over subgroups stratified by testosterone recovery to supra-castrate level at 15 months after start of ADT.,"[{'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland; Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Morgan', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: smalone@toh.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.017']
1133,32573795,Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans.,"OBJECTIVE


To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine.
BACKGROUND


Calcitonin gene-related peptide is a potent vasodilatory neurotransmitter believed to play a key role in the pathophysiology of migraine. Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine. Sumatriptan is a serotonin receptor agonist and the most commonly used triptan for the acute treatment of migraine. Ubrogepant could be prescribed with triptans.
DESIGN


The Phase 1 study was a single-center, open-label, randomized, 3-way crossover, single-dose, pharmacokinetic interaction study, where participants received each of 3 oral treatments with a 7-day washout period between treatments: single dose of ubrogepant 100 mg, single dose of sumatriptan 100 mg, and ubrogepant 100 mg plus sumatriptan 100 mg. Pharmacokinetic parameters were calculated using a model-independent approach. The ACHIEVE I and II trials were 2 multicenter, single-attack, randomized, Phase 3 trials in adults with a history of migraine with or without aura. Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48 hours after the initial dose of study medication. Rescue medication options included acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, anti-emetics, or triptans. Treatment-emergent adverse events were evaluated up to 30 days after the last dose in the Phase 1 and Phase 3 studies.
RESULTS


Ubrogepant median time to maximum plasma concentration was delayed (3 hours [range: 1-5 hours] vs 1.5 hours [range: 1-4 hours]), mean maximum plasma concentration was reduced by 24% (coefficient of variation: 37.4%) when ubrogepant was coadministered with sumatriptan (n = 29) compared with ubrogepant administered alone (N = 30). No significant effect was observed on the area under the plasma concentration-time curve of ubrogepant. Sumatriptan area under the curve and maximum plasma concentration showed no significant change when sumatriptan was coadministered with ubrogepant (n = 29), but the sumatriptan time to maximum plasma concentration was delayed (1 hour [range: 0.5-5 hours] vs 3 hours [range: 0.5-6 hours]. No treatment-emergent adverse events were reported with the coadministration of ubrogepant 100 mg and sumatriptan 100 mg in the Phase 1 study. The pooled safety data from ACHIEVE trials (N = 1938) showed similar rates of treatment-related treatment-emergent adverse events between participants who took ubrogepant alone and participants who took ubrogepant and a triptan as a rescue medication (14.9% [53/355] vs 12.8% [5/39] in the ubrogepant 100 mg treatment group, respectively).
CONCLUSIONS


Although there were slight alterations in ubrogepant pharmacokinetic parameters when coadministered with sumatriptan, such changes are expected to have minimal clinical relevance, especially because no changes were seen in sumatriptan area under the curve and maximum plasma concentration when coadministered with ubrogepant. Coadministration of ubrogepant with sumatriptan was well tolerated in healthy participants in the Phase 1 study, and coadministration of ubrogepant with triptans was well tolerated in participants with migraine in the Phase 3 trials. No new safety concerns for ubrogepant were identified across all trials.",2020,Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine.,"['Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48\xa0hours after the initial dose of study medication', 'participants with migraine', 'adults with a history of migraine with or without aura', 'participants with migraine in the Phase 3 trials', 'healthy participants']","['Ubrogepant Coadministered With Sumatriptan', 'ubrogepant 100\xa0mg, single dose of sumatriptan 100\xa0mg, and ubrogepant 100\xa0mg plus sumatriptan 100\xa0mg', 'sumatriptan', 'Sumatriptan']","['Sumatriptan area under the curve and maximum plasma concentration', 'mean maximum plasma concentration', 'acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, anti-emetics, or triptans', 'Ubrogepant median time to maximum plasma concentration', 'sumatriptan time to maximum plasma concentration', 'rates of treatment-related treatment-emergent adverse events', 'safety and tolerability', 'area under the plasma concentration-time curve of ubrogepant', 'Pharmacokinetic parameters']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1126059', 'cui_str': 'Sumatriptan 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0162754', 'cui_str': 'Serotonin 5-HT1 receptor agonist'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0313899,Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine.,"[{'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McGeeney', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}]",Headache,['10.1111/head.13862']
1134,32574895,Randomized controlled study comparing tonsillectomy safety and patient satisfaction outcomes between HARMONIC ACE® + shears and monopolar diathermy in an adult population - A pilot study.,"PURPOSE


Various types of the harmonic scalpel blades have been used for tonsillectomy since the early 2000s with varying successes. The HARMONIC ACE® + 23 cm shears is a relatively new blade which has not been studied in an adult population yet.
METHODOLOGY


A randomized controlled pilot study was performed comparing the HARMONIC ACE® + 23 cm shears (HS) and monopolar electrocautery (EC) tonsillectomy in 20 patients. Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes were compared between these two arms.
RESULTS


The operative time was comparable. Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm. Post-operative pain scores and use of analgesia were similar. There was earlier return to normal diet and activity in the HS arm compared to the EC arm. More patients in the HS arm recommended using HARMONIC ACE® + 23 cm shears compared to those in the EC arm. This is a non-inferiority study which suggests that the HARMONIC ACE® + 23 cm shears is comparable to monopolar electrocautery in terms of efficacy and post-operative complication rates with better patient satisfaction outcomes. The main weakness of the study is a small study population.
CONCLUSION


This is the first reported study comparing the use of the HARMONIC ACE® + 23 cm shears with monopolar cautery in tonsillectomy. A prospective adequately powered study validated by objective outcome measures would be useful to verify the findings from this pilot study.",2020,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.",['20 patients'],"['ACE®\xa0+\xa0shears and monopolar diathermy', 'harmonic scalpel blades', 'ACE®\xa0+\xa023\xa0cm shears (HS) and monopolar electrocautery (EC) tonsillectomy', 'ACE®\xa0+\xa023\xa0cm shears with monopolar cautery in tonsillectomy']","['Post-operative pain scores and use of analgesia', 'intraoperative bleeding, lower risks of delayed haemorrhage and readmission', 'operative time', 'Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0007471', 'cui_str': 'Cauterization - action'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0502624,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.","[{'ForeName': 'Wei Ming James', 'Initials': 'WMJ', 'LastName': 'Kwek', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu May Celeste Ann', 'Initials': 'SMCA', 'LastName': 'Chua', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu Hui', 'Initials': 'SH', 'LastName': 'Xu', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Toh Hui Leonard', 'Initials': 'THL', 'LastName': 'Tan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Xin Yong', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Tee Sin', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore. Electronic address: lee.tee.sin@singhealth.com.sg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102568']
1135,32444033,The effect of lavender herbal tea on the anxiety and depression of the elderly: A randomized clinical trial.,"BACKGROUND


The prevalence of depression and anxiety is increasing among the elderly around the world. It is believed that lavender can stabilize the people's mood, so this study was designed to evaluate the effect of lavender on anxiety and depression of the elderly.
METHODS


This study was a single blind clinical trial with a control group. The participants in the study consisted of 60 elderly subjects (30 in each group) who referred to the Health Center of Larestan city in the south of Iran in 2019. The intervention consisted of using 2 g of lavender teabag, which was prescribed to be used 2 times as decoction in the morning and night. The duration of the intervention was 2 weeks. The eligible participants were randomly assigned to the intervention and control groups using balanced block randomization with a block size of ten. The control group did not receive any placebo. Data collection tools in this study included demographic information questionnaire, Beck Depression and Spiel Berger Anxiety Inventory. Chi-square test and independent t-test were used to analyze the data. The significance level was considered 5 %.
RESULTS


The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference. The mean score of depression in the intervention group before and after drinking lavender herbal tea was 17.80 ± 1.49 and 16.33 ± 1.49, respectively. The mean score of depression between intervention and control groups after drinking herbal tea were 16.33 ± 1.49 and 18.33 ± 1.84, respectively. This indicated the effect of herbal tea on reducing depression (P < 0.001). Also, mean difference of intervention and control groups after drinking herbal tea in terms of depression and anxiety (state and trait) were (-2.00, 95 % CI (-2.86, -1.13)), (-6.40, 95 % CI (-9.43, -3.36)) and (-4.13, 95 % CI (-7.66, -0.60)), respectively.
CONCLUSION


The results of the present study showed that consumption of lavender herbal tea can reduce depression and anxiety scores and since it is inexpensive and accessible, it is suggested to be used as a complementary treatment in reducing anxiety and depression.",2020,"The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference.","['anxiety and depression of the elderly', '60 elderly subjects (30 in each group) who referred to the Health Center of Larestan city in the south of Iran in 2019']","['placebo', 'herbal tea', 'lavender herbal tea', 'lavender']","['reducing depression', 'mean score of depression', 'demographic information questionnaire, Beck Depression and Spiel Berger Anxiety Inventory', 'depression and anxiety scores', 'depression and anxiety (state and trait']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019233', 'cui_str': 'Herbal tea'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1301808', 'cui_str': 'State'}]",60.0,0.0480723,"The two groups were similar in terms of age, gender, educational level and marital status and there was no significant difference.","[{'ForeName': 'Mohammad-Rafi', 'Initials': 'MR', 'LastName': 'Bazrafshan', 'Affiliation': 'Department of Nursing, School of Nursing, Larestan University of Medical Sciences, Larestan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Jokar', 'Affiliation': 'Department of Nursing, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Shokrpour', 'Affiliation': 'English Department, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Delam', 'Affiliation': 'Student Research Committee, Larestan University of Medical Sciences, Larestan, Iran. Electronic address: hameddelam8@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102393']
1136,32683215,Intensive upper extremity training improved whole body movement control for children with unilateral spastic cerebral palsy.,"BACKGROUND


Children with unilateral spastic cerebral palsy (USCP) exhibit impaired bimanual coordination, gait control, and whole body movement control. Intensive upper extremity training has been found to be effective for improving upper extremity function. However, the effectiveness of the intensive upper extremity training on whole body movement control is not known.
RESEARCH QUESTION


The present study aimed to evaluate the effects of Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT) on bimanual coordination and gait control during a complex whole body task.
METHODS


Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS: I-II, MACS: I-II) were randomly assigned to either CIMT or HABIT for 6 h per day training for 15 days. Children were asked to perform two whole body tasks (walking with and without a tray carrying) while 3-D kinematic analysis was performed before and after training.
RESULTS


After training, the HABIT group increased the symmetry in height of their hands during tray carrying (more leveled tray). Both CIMT and HABIT groups decreased the lateral motion of the tray. The CIMT group increased speed and stride length after training in both the walking and tray carrying tasks. Both groups also increased their minimum toe clearance (all p < 0.05).
SIGNIFICANCE


Two types of intensive upper extremity training have provided significant improvements to whole body movement control for children with USCP. Adhering to the specificity of practice concept, HABIT improved bimanual coordination after training during the whole body tray carrying tasks. Given extensive interactions between the upper and lower extremities in real-world activities, future studies should focus on the effects of such combined training.",2020,"Both groups also increased their minimum toe clearance (all p < 0.05).
","['children with unilateral spastic cerebral palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', 'Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS']","['CIMT or HABIT', 'Intensive upper extremity training improved whole body movement control', 'CIMT', 'Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT', 'intensive upper extremity training', 'Intensive upper extremity training']","['bimanual coordination and gait control', 'symmetry in height of their hands', 'speed and stride length', 'lateral motion of the tray', 'minimum toe clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",16.0,0.0108967,"Both groups also increased their minimum toe clearance (all p < 0.05).
","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA. Electronic address: yaching.hung@qc.cuny.edu.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shirzad', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Box 199, NY 10027, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.009']
1137,32553337,Safety and Efficacy of Protamine Administration for Prevention of Bleeding Complications in Patients Undergoing TAVR.,"OBJECTIVES


The aim of this study was to evaluate whether protamine administration for heparin reversal after transcatheter aortic valve replacement (TAVR) reduces bleeding complications and affects patient outcomes.
BACKGROUND


Occurrence of major bleeding complications in patients undergoing TAVR is associated with increased morbidity and mortality.
METHODS


This study included 873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal. Standard access management included the use of pre-closure devices, manual compression, and percutaneous transluminal angioplasty or implantation of a covered stent graft, if necessary. The study complied with Good Clinical Practice guidelines and was approved by the local ethics committee. Written informed consent was obtained from all patients.
RESULTS


The primary endpoint, a composite of 30-day all-cause mortality and life-threatening and major bleeding, occurred less frequently in the protamine administration group (3.2%) compared with the control group (8.7%) (p = 0.003). This was driven mainly by lower rates of life-threatening and major bleeding in the protamine group (0.1% vs. 2.6% [p < 0.001] and 1.0% vs. 4.1% [p = 0.008], respectively). Furthermore, protamine administration resulted in a significantly shorter hospital stay (11.1 ± 5.8 days vs. 12.7 ± 7.8 days; p = 0.05). In the overall cohort, stroke was observed in 1.9% and myocardial infarction in 0.2% of patients, with no significant difference between the groups (p > 0.05). Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
CONCLUSIONS


Protamine administration resulted in significantly lower rates of life-threatening and major bleeding complications compared with patients without heparin reversal. Occurrence of stroke and myocardial infarction was not increased by protamine administration.",2020,"Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
","['873 patients undergoing TAVR, of whom 677 received protamine for heparin reversal', 'patients undergoing TAVR', 'Patients Undergoing TAVR']","['Protamine Administration', 'transcatheter aortic valve replacement (TAVR', 'percutaneous transluminal angioplasty or implantation of a covered stent graft', 'protamine']","['rates of life-threatening and major bleeding', 'Safety and Efficacy', 'Occurrence of stroke and myocardial infarction', 'bleeding complications', 'composite of 30-day all-cause mortality and life-threatening and major bleeding', 'acute kidney injury', 'shorter hospital stay', 'myocardial infarction', 'rates of life-threatening and major bleeding complications', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",873.0,0.261933,"Multivariate analysis revealed that only protamine administration (odds ratio: 0.24; 95% confidence interval: 0.10 to 0.58; p = 0.001) and acute kidney injury (odds ratio: 5.82; 95% confidence interval: 2.02 to 16.77; p = 0.001) were independently associated with the primary endpoint.
","[{'ForeName': 'Baravan', 'Initials': 'B', 'LastName': 'Al-Kassou', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Kandt', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Lohde', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Shamekhi', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedaghat', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Tabata', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sugiura', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Department of Medical Biometry, Informatics, and Epidemiology, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Werner', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Grube', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Treede', 'Affiliation': 'Heart Center, Department of Cardiac Surgery, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nickenig', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Jan-Malte', 'Initials': 'JM', 'LastName': 'Sinning', 'Affiliation': 'Heart Center, Department of Medicine II, University Hospital Bonn, Bonn, Germany. Electronic address: jan-malte.sinning@ukbonn.de.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.03.041']
1138,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1139,32562573,"Genetic Variation in PEAR1, Cardiovascular Outcomes and Effects of Aspirin in a Healthy Elderly Population.","The platelet endothelial aggregation receptor-1 (PEAR1) rs12041331 variant has been identified as a genetic determinant of platelet aggregation in response to antiplatelet therapies, including aspirin. However, association with atherothrombotic cardiovascular events is less clear, with limited evidence from large trials. Here, we tested association of rs12041331 with cardiovascular events and aspirin use in a randomized trial population of healthy older individuals. We undertook post hoc analysis of 13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years. Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrollment, and were randomized to either 100 mg daily low-dose aspirin or placebo for median 4.7 years follow-up. We used Cox proportional hazard regression to model the relationship between rs12041331 and the ASPREE primary cardiovascular disease (CVD) end point, and composites of major adverse cardiovascular events (MACE) and ischemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB). We performed whole-population analysis using additive and dominant inheritance models, then stratified by treatment group. Interaction effects between genotypes and treatment group were examined. We observed no statistically significant association (P < 0.05) in the population, or by treatment group, between rs12041331 and cardiovascular or bleeding events in either model. We also found no significant interaction effects between rs12041331-A and treatment group, for CVD (P = 0.65), MACE (P = 0.32), STROKE (P = 0.56), MHEM (P = 0.59), or ICB (P = 0.56). The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.",2020,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"['healthy older individuals', 'Participants had no previous diagnosis of atherothrombotic cardiovascular disease at enrolment', 'healthy elderly population', 'N=13,547 participants of the ASPirin in Reducing Events in the Elderly (ASPREE) trial, median age 74 years']","['aspirin', 'aspirin or placebo']","['cardiovascular disease endpoint (CVD), and composites of major adverse cardiovascular events (MACE) and ischaemic stroke (STROKE); and bleeding events; major hemorrhage (MHEM) and intracranial bleeding (ICB', 'Interaction effects', 'rs12041331 and cardiovascular or bleeding events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",13547.0,0.0373115,The genetic variant PEAR1 rs12041331 is not associated with cardiovascular events in response to low-dose aspirin in a healthy elderly population.,"[{'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare, Minneapolis, Minnesota, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Shuldiner', 'Affiliation': 'Department of Medicine, Program for Personalized and Genomic Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lacaze', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1959']
1140,32564819,"Re: Goldberg et al.: A phase 3, randomized, double-masked study of OTX-101 ophthalmic solution 0.09% in the treatment of dry eye disease (Ophthalmology. 2019;126:1230-1237).",,2020,,['dry eye disease (Ophthalmology'],['OTX-101 ophthalmic solution'],[],"[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0015399', 'cui_str': 'Eye drops'}]",[],,0.335132,,"[{'ForeName': 'Mumta', 'Initials': 'M', 'LastName': 'Kanda', 'Affiliation': 'Department of Ophthalmology, Royal Hospital London, London, UK. Electronic address: mumta.kanda1@nhs.net.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Nowak', 'Affiliation': 'Department of Ophthalmology, Royal Hospital London, London, UK.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.047']
1141,32564920,Efficacy and Safety of Intravitreal Sirolimus for Noninfectious Uveitis of the Posterior Segment: Results from the Sirolimus Study Assessing Double-Masked Uveitis Treatment (SAKURA) Program.,"PURPOSE


To evaluate the efficacy and safety of intravitreal sirolimus in the management of noninfectious uveitis of the posterior segment (NIU-PS).
DESIGN


Combined analysis of 2 phase 3, randomized, double-masked, multinational, 6-month studies.
PARTICIPANTS


Adults with active NIU-PS (intermediate uveitis, posterior uveitis, or panuveitis; defined as vitreous haze [VH] ≥1.5+ on modified Standardization of Uveitis Nomenclature scale).
METHODS


Patients were randomized 1:1:1 to receive intravitreal sirolimus 44 μg (n = 208), 440 μg (n = 208), or 880 μg (n = 177) on days 1, 60, and 120. Patients discontinued medications for NIU-PS except for systemic corticosteroids, which were tapered according to protocol. Enrollment in the 880-μg group was terminated after interim results found no significant difference in efficacy compared with the 440-μg dose.
MAIN OUTCOME MEASURES


The primary efficacy end point was the percentage of patients with VH of 0 at month 5 in the study eye without the use of rescue therapy. Secondary efficacy end points included VH of 0 or 0.5+, corticosteroid-tapering success, and changes in best-corrected visual acuity (BCVA). Safety measures included ocular and nonocular adverse events.
RESULTS


A total of 592 patients were randomized. Significantly higher proportions of patients treated with 440 μg compared with 44 μg intravitreal sirolimus achieved VH of 0 (21.2% vs. 13.5%; P = 0.038) and VH of 0 or 0.5+ (50.0% vs. 40.4%; P = 0.049) at month 5. Best-corrected visual acuity was stable (absolute change <5 ETDRS letters) or improved >5 letters in 80.1% and 80.2% of patients in the 440-μg and 44-μg groups, respectively. At month 5, corticosteroids were tapered successfully in 69.6% and 68.8% of patients in the 440-μg and 44-μg groups, and among these patients, VH of 0 or 0.5+ was achieved by 43.5% and 28.1% in the 440-μg and 44-μg groups. Both doses were generally well tolerated. Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups.
CONCLUSIONS


Intravitreal sirolimus 440 μg improved ocular inflammation, as measured by VH, compared with the 44-μg dose, with minimal impact on IOP, while preserving BCVA.",2020,"Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups.
","['592 patients were randomized', 'Patients', 'Noninfectious Uveitis of the Posterior Segment', 'Adults with active NIU-PS (intermediate uveitis, posterior uveitis, or panuveitis; defined as vitreous haze [VH] ≥1.5+ on modified Standardization of Uveitis Nomenclature scale', '440 μg (n\xa0= 208), or 880 μg (n\xa0= 177) on days 1, 60, and 120']","['Intravitreal Sirolimus', 'intravitreal sirolimus 44 μg ', 'intravitreal sirolimus']","['Efficacy and Safety', 'Mean changes from baseline intraocular pressure (IOP', 'tolerated', 'Best-corrected visual acuity', 'efficacy and safety', 'ocular inflammation', 'efficacy', 'ocular and nonocular adverse events', 'VH of 0 or 0.5+, corticosteroid-tapering success, and changes in best-corrected visual acuity (BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042166', 'cui_str': 'Intermediate uveitis'}, {'cui': 'C0042167', 'cui_str': 'Posterior uveitis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4073113', 'cui_str': 'Vitreous haze'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0600281', 'cui_str': 'Nomenclature'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",592.0,0.292917,"Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups.
","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Merrill', 'Affiliation': 'Department of Ophthalmology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'W Lloyd', 'Initials': 'WL', 'LastName': 'Clark', 'Affiliation': 'Department of Ophthalmology, Palmetto Retina Center, LLC, West Columbia, South Carolina.'}, {'ForeName': 'Alay S', 'Initials': 'AS', 'LastName': 'Banker', 'Affiliation': ""Banker's Retina Clinic and Laser Center, Navrangpura, Ahmedabad, India.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fardeau', 'Affiliation': 'Department of Ophthalmology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Franco', 'Affiliation': 'Organización Médica de Investigación, Buenos Aires, Argentina.'}, {'ForeName': 'Phuc', 'Initials': 'P', 'LastName': 'LeHoang', 'Affiliation': 'Department of Ophthalmology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Sivakumar R', 'Initials': 'SR', 'LastName': 'Rathinam', 'Affiliation': 'Department of Uveitis Services, Aravind Eye Hospital, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Ali', 'Affiliation': 'Ribomic USA Inc., Berkeley, California.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Mudumba', 'Affiliation': 'Global Biomedical Strategy and Research, Santen, Inc., Emeryville, California.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shams', 'Affiliation': 'Global Research and Development, Santen, Inc., Emeryville, California.'}, {'ForeName': 'Quan Dong', 'Initials': 'QD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California. Electronic address: ndquan@stanford.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.033']
1142,32583959,Bedside ultrasound in the emergency department for reduction and radial manipulation of distal radial fractures.,"OBJECTIVE


Distal radial fracture reduction is a common procedure in the ED. Previous studies have suggested that ultrasound (US)-guided reduction improves outcomes for patients who undergo manipulation and reduction of distal radial fractures in the ED. We aimed to investigate this with the first randomised controlled trial looking at US-guided distal radial fracture reduction. Our primary objective was to compare rates of operative intervention between the study groups. Rate of re-manipulation was compared as a secondary outcome.
METHODS


ED patients were prospectively randomised to either standard landmark guided or US-guided closed reduction of distal radial fractures. The closed reductions were performed by senior emergency clinicians and the USs were performed by emergency physicians experienced in point-of-care US. Following reduction patients were managed equally and referred to the local orthopaedic service who were blinded to whether US was used to assist manipulation or not. This service decided on the need for re-manipulation or operative intervention.
RESULTS


One hundred patients were enrolled and randomised equally into each cohort. We found no statistically significant difference between the control and intervention groups of our study. In the control group, 46% of patients underwent operative fixation, compared to 48% in the US-guided group (P = 0.36). Our secondary intervention of re-manipulation in the ED or theatre following the initial reduction showed no statistically significant difference between the groups (P = 1.0).
CONCLUSION


US-guided reduction of dorsally displaced, distal radius fractures in the ED setting, did not improve measured clinical outcomes.",2020,"In the control group, 46% of patients underwent operative fixation, compared to 48% in the US-guided group (P = 0.36).","['Following reduction patients were managed equally and referred to the local orthopaedic service', 'ED patients', 'One hundred patients were enrolled and randomised equally into each cohort']","['Bedside ultrasound', 'standard landmark guided or US-guided closed reduction of distal radial fractures', 'ultrasound (US)-guided reduction']","['Rate of re-manipulation', 'distal radial fractures']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0587690', 'cui_str': 'Orthopedic service'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}]",100.0,0.0515807,"In the control group, 46% of patients underwent operative fixation, compared to 48% in the US-guided group (P = 0.36).","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Smiles', 'Affiliation': 'Emergency Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Simonian', 'Affiliation': 'Orthopaedics, Mater Hospital Brisbane, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Emergency Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Digby', 'Affiliation': 'Emergency Medicine, John Hunter Hospital, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Vidler', 'Affiliation': 'Emergency Department, Maitland Hospital, Maitland, New South Wales, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Flannagan', 'Affiliation': 'Emergency Department, Maitland Hospital, Maitland, New South Wales, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13554']
1143,32443961,Primary Care Clinic Nurse Activities with a Telehealth Monitoring System.,"The purpose of this study was to evaluate differences in the types of nursing activities and communication processes reported in a primary care clinic between patients who used a home-based monitoring system to electronically communicate self-monitored blood glucose and blood pressure values and those who assumed usual care. Data were extracted from electronic medical records from individuals who participated in a randomized controlled trial comparing in-home monitoring and usual care in patients with Type 2 diabetes and hypertension being treated in a primary care clinic. Data about nursing activities initiated by primary care clinic nurses were compared between groups using descriptive statistics and independent  t -tests. Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up. This study provides evidence of greater nursing activity reported in a primary care clinic in patients who utilized a home-based monitoring system.",2020,"Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up.","['patients with Type 2 diabetes and hypertension being treated in a primary care clinic', 'patients who utilized a home-based monitoring system', 'patients who used a home-based monitoring system to electronically communicate self-monitored blood glucose and blood pressure values and those who assumed usual care']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",[],[],,0.0129672,"Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up.","[{'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Howland', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Despins', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Jeri', 'Initials': 'J', 'LastName': 'Sindt', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Wakefield', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mehr', 'Affiliation': 'Curtis W. and Ann H. Long Department of Family and Community Medicine, School of Medicine, University of Missouri, Columbia, MO, USA.'}]",Western journal of nursing research,['10.1177/0193945920923082']
1144,32444901,"A Randomized Controlled Trial of a Texting Intervention to Maintain Sexual Risk Reduction with Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico.","Mobile phone technology may help sustain reductions in HIV/STI transmission risk behaviors among female sex workers (FSWs). We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico. We hypothesized that FSWs who received brief risk reduction counseling and theory-based safer sex maintenance text messages over a 24-month period would have fewer incident HIV/STIs and report greater maintenance of safer sex practices compared to FSWs who received counseling and texts on maintaining general health. Theory-based texts did not change the odds of becoming infected with HIV/STIs in either study site. However, they did lead to significant, sustained protected sex in Tijuana. Theory-based text messaging interventions may help sustain reductions in sexual risk behavior among FSWs.Trial Registration Clinical Trials.gov. Identifier: NCT02447484.",2020,"We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico.","['Clients Among Female Sex Workers in Tijuana and Ciudad Juarez, Mexico', 'female sex workers (FSWs', 'safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico']","['brief risk reduction counseling and theory-based safer sex maintenance text messages', 'Texting Intervention', 'text messaging intervention']",[],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]",[],,0.0894895,"We examined the efficacy of a text messaging intervention designed to maintain behavioral improvements in safer sex practices among 602 FSWs in Tijuana and Ciudad Juarez, Mexico.","[{'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA. tpatterson@ucsd.edu.'}, {'ForeName': 'Eileen V', 'Initials': 'EV', 'LastName': 'Pitpitan', 'Affiliation': 'School of Social Work, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Pines', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Shirley J', 'Initials': 'SJ', 'LastName': 'Semple', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Harvey-Vera', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Depp', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Moore', 'Affiliation': 'Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, Mail Code 0680, La Jolla, CA, 92093, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Federación Méxicana de Asociaciones Privadas (FEMAP), Ciudad Juarez, Chihuahua, Mexico.'}, {'ForeName': 'M Gudelia', 'Initials': 'MG', 'LastName': 'Rangel', 'Affiliation': 'US-Mexico Border Health Commission, Tijuana, Baja California, Mexico.'}, {'ForeName': 'Steffanie A', 'Initials': 'SA', 'LastName': 'Strathdee', 'Affiliation': 'Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02930-1']
1145,32579971,When the camera eats first: Exploring how meal-time cell phone photography affects eating behaviours.,"Advances in cell phone technology have the potential to disrupt eating patterns. In this research, we focused on the camera function of a cell phone, characterizing: (i) the extent to which this function is used during meals; (ii) whether meal-time photographers show signs of pathological eating; and (iii) whether the act of taking food photographs alters the amount and enjoyment of food eaten. In the first study, we used the experience sampling method to track one week of meals from 137 young adults. Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not. That is, these meal-time photographers were more likely to eat in response to external cues (e.g. the sight of palatable food) than to internal cues of hunger. However, when participants were randomly assigned to take either food or non-food photographs within a lab setting (Study 2), we found no evidence that the type of photography influenced either the amount or enjoyment of food eaten. Taken together, our findings suggest a limited role for cell phone photography in an obesogenic environment.",2020,"Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not.",['137 young adults'],"['type of photography influenced either the amount or enjoyment of food eaten', 'food or non-food photographs']",['external eating scores'],"[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",137.0,0.0170038,"Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not.","[{'ForeName': 'Joceline Y Y', 'Initials': 'JYY', 'LastName': 'Yong', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, 16 College Avenue West, Singapore, 138527, Singapore.'}, {'ForeName': 'Eddie M W', 'Initials': 'EMW', 'LastName': 'Tong', 'Affiliation': 'Department of Psychology, National University of Singapore, 9 Arts Link, Singapore, 117572, Singapore.'}, {'ForeName': 'Jean C J', 'Initials': 'JCJ', 'LastName': 'Liu', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, 16 College Avenue West, Singapore, 138527, Singapore; Neuroscience and Behavioral Disorders Programme, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. Electronic address: jeanliu@yale-nus.edu.sg.'}]",Appetite,['10.1016/j.appet.2020.104787']
1146,32446842,Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.,"PURPOSE


To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections.
DESIGN


Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012).
PARTICIPANTS


Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included.
METHODS


A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT.
MAIN OUTCOME MEASURES


We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC.
RESULTS


A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001).
CONCLUSIONS


Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.",2020,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","['22 patients undergoing', 'A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC', 'eyes treated with cooling anesthesia', 'Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included']","['standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia', 'Ultra-Rapid Cooling Anesthesia', 'bilateral IVT', 'cooling anesthesia']","['Mild, transient adverse events', 'Mean VAS pain scores', 'Mean±SEM pain scores', 'toxicity', 'mean±standard error of the mean (SEM) VAS pain scores', 'Total mean±SEM procedure time', 'Subjective pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2237660', 'cui_str': 'Wet Macular Degeneration'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",22.0,0.0922038,"Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC.","[{'ForeName': 'Cagri G', 'Initials': 'CG', 'LastName': 'Besirli', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. Electronic address: cbesirli@med.umich.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Smith', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University School of Medical, Palo Alto, California; iRenix Medical, Inc., Palo Alto, California.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Zacks', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Pipe', 'Affiliation': 'Department of Mechanical Engineering, University of Michigan, Ann Arbor, Michigan; Department of Electrical Engineering and Computer Science, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Anjali R', 'Initials': 'AR', 'LastName': 'Shah', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, W. K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.04.001']
1147,32453304,Effects of Different Plyometric Training Frequencies on Measures of Athletic Performance in Prepuberal Male Soccer Players.,"Bouguezzi, R, Chaabene, H, Negra, Y, Ramirez-Campillo, R, Jlalia, Z, Mkaouer, B, and Hachana, Y. Effects of different plyometric training frequencies on measures of athletic performance in prepuberal male soccer players. J Strength Cond Res 34(6): 1609-1617, 2020-This study aimed to compare the effects of 1 vs. 2 sessions of equal-weekly volume plyometric training (PT) across 8 weeks on measures of athletic performance (i.e., sprint time, change of direction [CoD], jumping ability, and muscle strength) in prepuberal male soccer players. Thirty participants were randomly assigned either to 1 session PT group (1SPT [n = 15]) or 2 sessions PT group (2SPT [n = 15]). Plyometric training was integrated into their regular soccer training routine. Pretraining and posttraining tests for the assessment of sprint time (e.g., 5, 10, 20, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], countermovement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance were conducted. Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94 [large], p = 0.02), SLJ (F(1,56) = 16.63, ES = 1.09 [large], p < 0.001), CMJ (F(1,56) = 15.43, ES = 1.04 [large], p < 0.001), SJ (F(1,56) = 20.27, ES = 1.20 [large], p < 0.001), RSI (F(1,56) = 26.26, ES = 1.36 [large], p < 0.001), and kicking distance (F(1,56) = 47.19, ES = 1.83 [large], p < 0.001). There were no training group × time interactions in all the measured outcomes. In conclusion, when an equated moderate volume of jumps is performed, higher PT frequency across 8 weeks has no extra effects on prepuberal male soccer players' measures of athletic performance. The present findings may help optimizing PT interventions dedicated to prepuberal male soccer players.",2020,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94","['Prepuberal Male Soccer Players', 'J Strength Cond Res 34(6', 'prepuberal male soccer players', 'Thirty participants']","['Plyometric Training Frequencies', 'equal-weekly volume plyometric training (PT', 'Plyometric training']","['athletic performance (i.e., sprint time, change of direction [CoD], jumping ability, and muscle strength', 'sprint time (e.g., 5, 10, 20, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], countermovement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance', 'Athletic Performance', 'time interactions', 'time for 5-m sprint-time performance', 'athletic performance', 'Bouguezzi, R, Chaabene, H, Negra, Y, Ramirez-Campillo, R, Jlalia, Z, Mkaouer, B, and Hachana']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",30.0,0.0338811,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56) = 4.00, effect size [ES] = 0.53 [medium], p = 0.05), T-test (F(1,56) = 23.19, ES = 1.28 [large], p < 0.001), MICODT (F(1,56) = 5.72, ES = 0.94","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, University of Los Lagos, Osorno, Chile.'}, {'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Jlalia', 'Affiliation': 'Faculty of Medicine of Tunis, University of Tunis El Manar, Orthopedic Pediatric Department, Kassab Institute of Orthopedic Surgery, Ksar Said, Tunisia.'}, {'ForeName': 'Bessem', 'Initials': 'B', 'LastName': 'Mkaouer', 'Affiliation': 'Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Younés', 'Initials': 'Y', 'LastName': 'Hachana', 'Affiliation': 'Research Unit (UR17JS01), ""Sport Performance and Health,"" Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002486']
1148,32453306,Chronopharmacokinetics and Food Effects of Single-Dose LCP-Tacrolimus in Healthy Volunteers.,"BACKGROUND


A modified-release version of tacrolimus, LCP-tacrolimus (LCPT; Envarsus XR, Veloxis Pharmaceuticals, Cary, NC), has been licensed in the United States for prophylaxis of organ rejection in de novo kidney transplant patients. As tacrolimus has a narrow therapeutic window, the impact of circadian patterns on LCPT drug exposure, including food and chronopharmacokinetic effects, needs to be elucidated to optimize dosing.
METHODS


Two randomized, crossover, phase 1 studies were conducted in healthy volunteers. The first assessed the effect of morning versus evening dosing on the pharmacokinetic profile of LCPT 2 mg; the second assessed the effect of food on the pharmacokinetic profile of LCPT 5 mg. In both, blood samples were drawn from participants for up to 144 hours after administration of a single LCPT dose.
RESULTS


No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 versus 4.0 ng/mL; P = 0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 versus 102.6 ng/mL; P = 0.20), AUC from time 0 to infinity (99.7 versus 114.3 ng·h/mL; P = 0.18), AUC from 0 to 24 hours post-dose (AUC0-24; 49.4 versus 51.6 ng·h/mL; P = 0.56), time to reach maximum blood concentration (median, 6.0 versus 6.0 hours; P = 0.91), total clearance (arithmetic mean = 21.5 versus 19.5 L/h; P = 0.50), or terminal half-life (arithmetic mean = 26.8 versus 28.1 hours; P = 0.26). After a high-calorie meal in the morning, the AUC0-24 reduced by 54% (ratio of geometric means = 45.6%; P < 0.0001) and peak blood concentration reduced by 22% (ratio of geometric means = 78.4%; P = 0.0006). However, the terminal half-life did not differ between fasted and fed states (33.3 versus 34.8 hours; P = 0.16), implying that these differences occurred because of altered bioavailability rather than modified clearance.
CONCLUSIONS


For LCPT, no chronopharmacokinetic effects were observed, whereas food significantly reduced the 24-h exposure and the peak blood concentration.",2020,"No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26).","['Healthy Volunteers', 'novo kidney transplant patients', 'healthy volunteers']","['Single-Dose LCP-tacrolimus', 'tacrolimus', 'tacrolimus, LCP-tacrolimus (LCPT']","['total clearance', '24-h exposure and the peak blood concentration', 'time to reach maximum blood concentration', 'area under the time-concentration curve (AUC', 'peak blood concentration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.169971,"No significant differences were observed between evening and morning dosing in peak blood concentration (4.4 vs. 4.0 ng/mL; p=0.27), area under the time-concentration curve (AUC) from time 0 to time of the last concentration (89.1 vs. 102.6 ng/mL; p=0.20), AUC from time 0 to infinity (99.7 vs. 114.3 ng·h/mL; p=0.18), AUC from 0 to 24 h post-dose (AUC0-24; 49.4 vs. 51.6 ng·h/mL; p=0.56), time to reach maximum blood concentration (median, 6.0 vs. 6.0 h; p=0.91), total clearance (arithmetic mean = 21.5 vs. 19.5 L/h; p=0.50), or terminal half-life (arithmetic mean = 26.8 vs. 28.1 h; p=0.26).","[{'ForeName': 'Rita R', 'Initials': 'RR', 'LastName': 'Alloway', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Trofe-Clark', 'Affiliation': 'Department of Pharmacy, Hospital of the University of Pennsylvania and Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Brennan', 'Affiliation': 'Comprehensive Transplant Center, The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Kerr', 'Affiliation': 'UC San Diego Health, San Diego, California.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Cohen', 'Affiliation': 'Department of Transplantation, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Meier-Kriesche', 'Affiliation': 'Medical Affairs Department, Veloxis Pharmaceuticals, Cary, North Carolina.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Stevens', 'Affiliation': 'Medical Affairs Department, Veloxis Pharmaceuticals, Cary, North Carolina.'}, {'ForeName': 'Misbah A', 'Initials': 'MA', 'LastName': 'Moten', 'Affiliation': 'Medical Affairs Department, Veloxis Pharmaceuticals, Cary, North Carolina.'}, {'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'Division of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego, La Jolla, California.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000773']
1149,32459282,"Resistant starch supplementation effects on plasma indole 3-acetic acid and aryl hydrocarbon receptor mRNA expression in hemodialysis patients: Randomized, double blind and controlled clinical trial.","INTRODUCTION


Gut microbiota imbalance is linked to high uremic toxins production such as indole-3-acetic acid (IAA) in chronic kidney disease patients. This toxin can activate the aryl hydrocarbon receptor (AhR), a ligand-activated transcription factor involved with inflammation. Strategies to restore gut microbiota balance can be associated with reduced production of IAA and its deleterious effects. This study aimed to evaluate prebiotic resistant starch (RS) supplementation effects on IAA plasma levels and AhR mRNA expression in CKD patients on hemodialysis (HD).
METHODS


This randomized, double-blind and placebo-controlled clinical trial evaluated forty-two stable HD patients allocated in RS (n=22) or placebo (n=20) groups. Patients received, alternately, cookies and sachets containing 16 g/day of RS (Hi-Maize 260®) or manioc flour for four weeks. Fasting pre-dialysis blood samples were collected and IAA plasma levels measured by high performance liquid chromatography. Peripheral blood mononuclear cells were isolated and processed for AhR and nuclear factor kappa B (NF-κB) mRNA expression analyzes by quantitative real-time PCR. Anthropometric and biochemical parameters, as well as food intake were also evaluated.
RESULTS


Thirty-one patients completed the study, 15 in the RS group and 16 in the placebo group. Although there was no significant alteration in IAA plasma levels, neither in AhR mRNA expression and NF-κB mRNA expression after RS supplementation, a positive correlation (r=0.48; p=0.03) was observed between IAA plasma levels and AhR expression at baseline.
CONCLUSION


Even though prebiotic RS supplementation did not influence IAA levels or AhR expression, their positive association reinforces a possible interaction between them.",2020,"Although there was no significant alteration in IAA plasma levels, neither in AhR mRNA expression and NF-κB mRNA expression after RS supplementation, a positive correlation (r=0.48; p=0.03) was observed between IAA plasma levels and AhR expression at baseline.
","['CKD patients on hemodialysis (HD', 'forty-two stable HD patients allocated in RS (n=22) or', 'chronic kidney disease patients', 'n=20) groups', 'hemodialysis patients']","['placebo', 'prebiotic RS supplementation', 'Resistant starch supplementation', 'prebiotic resistant starch (RS) supplementation']","['Peripheral blood mononuclear cells', 'IAA plasma levels', 'IAA plasma levels and AhR expression', 'AhR mRNA expression and NF-κB mRNA expression', 'IAA plasma levels and AhR mRNA expression']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0936060', 'cui_str': 'Indoleacetic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0052441', 'cui_str': 'Aryl Hydrocarbon Receptor'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",42.0,0.14231,"Although there was no significant alteration in IAA plasma levels, neither in AhR mRNA expression and NF-κB mRNA expression after RS supplementation, a positive correlation (r=0.48; p=0.03) was observed between IAA plasma levels and AhR expression at baseline.
","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Azevedo', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Esgalhado', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}, {'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Kemp', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Médicas, Niterói, RJ, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Regis', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Médicas, Niterói, RJ, Brazil.'}, {'ForeName': 'Ludmila Fmf', 'Initials': 'LF', 'LastName': 'Cardozo', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}, {'ForeName': 'Lia S', 'Initials': 'LS', 'LastName': 'Nakao', 'Affiliation': 'Universidade Federal do Paraná, Programa de Pós-graduação em Ciências Médicas, Curitiba, PR, Brazil.'}, {'ForeName': 'Jessyca Sousa de', 'Initials': 'JS', 'LastName': 'Brito', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Médicas, Niterói, RJ, Brazil.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Mafra', 'Affiliation': 'Universidade Federal Fluminense, Programa de Pós-graduação em Ciências Cardiovasculares, Niterói, RJ, Brazil.'}]",Jornal brasileiro de nefrologia : 'orgao oficial de Sociedades Brasileira e Latino-Americana de Nefrologia,['10.1590/2175-8239-JBN-2020-0003']
1150,32565123,An acute bout of swimming increases post-exercise energy intake in young healthy men and women.,"Single bouts of land-based exercise (for example, walking, running, cycling) do not typically alter post-exercise energy intake on the day of exercise. However, anecdotal and preliminary empirical evidence suggests that swimming may increase appetite and energy intake. This study compared the acute effects of swimming on appetite, energy intake, and food preference and reward, versus exertion-matched cycling and a resting control. Thirty-two men (n = 17; mean ± SD age 24 ± 2 years, body mass index [BMI] 25.0 ± 2.6 kg/m 2 ) and women (n = 15; age 22 ± 3 years, BMI 22.8 ± 2.3 kg/m 2 ) completed three experimental trials (swimming, cycling, control) in a randomised, crossover design. The exercise trials involved 60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast. Food preference and reward were assessed via the Leeds Food Preference Questionnaire 15-min after exercise, whilst ad libitum energy intake was determined 30-min after exercise. The control trial involved identical procedures except no exercise was performed. Compared with control (3259 ± 1265 kJ), swimming increased ad libitum energy intake (3857 ± 1611 kJ; ES = 0.47, 95% CI of the mean difference between trials 185, 1010 kJ, P = 0.005); the magnitude of increase was smaller after cycling (3652 ± 1619 kJ; ES = 0.31, 95% CI -21, 805 kJ, P = 0.062). Ad libitum energy intake was similar between swimming and cycling (ES = 0.16, 95% CI -207, 618 kJ, P = 0.324). This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control. This study has identified an orexigenic effect of swimming. Further research is needed to identify the responsible mechanism(s), including the relevance of water immersion and water temperature per se.",2020,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"['young healthy men and women', 'Thirty-two men (n\u202f=\u202f17; mean\u202f±\u202fSD age 24\u202f±\u202f2 years, body mass index [BMI] 25.0\u202f±\u202f2.6\u202fkg/m 2 ) and women (n\u202f=\u202f15', 'age 22\u202f±\u202f3 years, BMI 22.8\u202f±\u202f2.3\u202fkg/m 2 ']","[""60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast"", 'Single bouts of land-based exercise']","['appetite, energy intake, and food preference and reward, versus exertion-matched cycling', 'Ad libitum energy intake', 'appetite and energy intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",,0.135485,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.E.Thackray@lboro.ac.uk.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: S.Willis2@lboro.ac.uk.'}, {'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.P.Sherry@lboro.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, UK. Electronic address: David.Clayton@ntu.ac.uk.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, UK. Electronic address: ad5173@coventry.ac.uk.'}, {'ForeName': 'Mayada', 'Initials': 'M', 'LastName': 'Demashkieh', 'Affiliation': 'Department of Physical Education and Sport Science, Nanyang Technological University, Singapore. Electronic address: Mayada.Demashkieh@nie.edu.sg.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, UK. Electronic address: js928@leicester.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK. Electronic address: L.James@lboro.ac.uk.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, UK. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: D.J.Stensel@lboro.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: j.a.king@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104785']
1151,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND


Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated.
MATERIALS AND METHODS


We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C.
RESULTS


A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant).
CONCLUSIONS


There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012']
1152,32569671,Feasibility of Surgical Resection After Induction Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Therapy for N2 Lung Adenocarcinomas.,"BACKGROUND


Prognosis of patients with stage IIIA-N2 lung adenocarcinoma is still not optimistic. The aim of this study was to evaluate safety, feasibility, and outcomes of surgery after induction epidermal growth factor receptor-tyrosine kinase inhibitor therapy in a clinical trial setting.
METHODS


Fourteen patients with IIIA-N2 lung adenocarcinoma and epidermal growth factor receptor mutation received erlotinib induction followed by surgery in a phase II clinical trial. Perioperative outcomes and survival results were compared with a control group of 15 patients receiving neoadjuvant chemotherapy during the same time period.
RESULTS


Thirteen patients showed partial response to induction, whereas 16 patients remained stable. Serum carcinoembryonic antigen level in the erlotinib group was significantly higher than in the chemotherapy group before treatment but was reduced to similar levels after induction. Operation time, blood loss, resection extents, complete resection rates, postoperative drainage, complication rates, and length of hospital stay were all comparable between the 2 groups. Thoracoscopic resection was accomplished in 78.6% of patients in the erlotinib group and 80.0% of patients in the chemotherapy group (P = .924) but was higher in patients who responded to induction than those who did not (92.3% vs 68.8%, P = .119). A resection extent greater than lobectomy and incomplete resections were only seen in stable disease after induction. No significant difference was detected in 1-year and 3-year overall or disease-free survivals between the 2 groups.
CONCLUSIONS


Pulmonary resection is safe and feasible after induction treatment with erlotinib for stage IIIA-N2 lung adenocarcinomas. Better surgical and oncologic outcomes may be expected in patients who respond to effective induction therapies.",2020,"No significant difference was detected in 1-year and 3-year overall or disease-free survivals between the two groups.
","['patients who respond to effective induction therapies', 'N2 lung adenocarcinomas', 'Fourteen patients with IIIA-N2 lung adenocarcinoma and EGFR mutation received erlotinib induction followed by surgery in a phase II clinical trial', 'patients with stage IIIA-N2 lung adenocarcinoma']","['erlotinib', 'surgical resection after induction EGFR-TKI therapy', 'neoadjuvant chemotherapy']","['1-year and 3-year overall or disease-free survivals', 'partial response to induction', 'Operation time, blood loss, resection extents, complete resection rates, postoperative drainage, complication rates and length of hospital stay', 'Serum carcinoembryonic antigen level', 'Thoracoscopic resection', 'Perioperative outcomes and survival results']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",14.0,0.026905,"No significant difference was detected in 1-year and 3-year overall or disease-free survivals between the two groups.
","[{'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': ""Department of Thoracic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Tangbing', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': ""Department of Thoracic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China. Electronic address: vwtfang@hotmail.com.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.04.133']
1153,32578325,Spaced education and student learning: Results from a medical school.,"BACKGROUND


It is critical for medical students to retain and apply their knowledge of basic sciences to become competent prescribing physicians. Poor long-term retention is a pervasive concern. We investigated the impact of 'spaced education' teaching modules to improve knowledge retention in medical students on a topic of public health: vitamin D and its role in health and disease. It is critical for medical students to retain and apply their knowledge of basic sciences to become competent prescribing physicians METHODS: In a self-matched design, 148 medical students were randomised and evaluated on vitamin D-related topics to assess reinforced and non-reinforced knowledge in a multiple-choice question format. Initial learning and long-term retention were assessed with an estimation of Cohen's effect size at 24 and 72 weeks, respectively.
RESULTS


The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33). Although the scores dipped, there was a retention of knowledge at 72 weeks (effect size = 0.48).
DISCUSSION


Spaced reinforcement and testing statistically improved knowledge retention among our medical students. Gaps in the present teaching could be bridged by motivating the students to extend their learning time by appropriate spacing intervals and to understand the relevance of course content in different scenarios as a physician. Further research could be instrumental in optimising interventions to enhance learning opportunities for medical students.",2020,"The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33).","['medical students on a topic of public health', 'medical students', '148 medical students']",['vitamin\xa0D-related topics to assess reinforced and non-reinforced knowledge'],"['knowledge retention', 'Initial learning and long-term retention', 'retention of knowledge', 'composite formative test scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",148.0,0.028314,"The administration of spaced educational material significantly improved composite formative test scores at 24 weeks (p < 0.001, effect size = 1.33).","[{'ForeName': 'Preeta K', 'Initials': 'PK', 'LastName': 'Chugh', 'Affiliation': 'Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Dehli, India.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Tripathi', 'Affiliation': 'Department of Pharmacology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Dehli, India.'}]",The clinical teacher,['10.1111/tct.13180']
1154,32444035,Effects of hydroalcoholic extract of Berberis Integerrima on the anthropometric indices and metabolic profile in active rheumatoid arthritis patients.,"OBJECTIVES


Since, the main cause of death in Rheumatoid arthritis (RA) patients is the presence of type 2 diabetes, abnormal increase in blood lipids, blood pressure and obesity, the aim of this study was to assess the effects of Barberry on the anthropometric indices and metabolic profile in patients with RA.
DESIGN


present study was a double-blinded, placebo-controlled randomized clinical trial.
SETTING


70 active RA patients were randomly allocated into intervention or placebo group INTERVENTION: Participants received 6 capsules of 500 mg barberry extract or placebo for 3 months.
MAIN OUTCOME MEASURES


Serum levels of fasting blood sugar (FBS), triglyceride (TG), LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C), systolic and diastolic blood pressure and anthropometric factors were assessed at baseline and at the end of the trial.
RESULTS


The results of intervention on 62 patients showed that weight, BMI, and conicity index increased in both groups, but this was significant only in the placebo group (p < 0.001). Waist and hip circumference were decreased in the intervention group and increased significantly in the placebo group (p < 0.001). Body fat percent (p = 0.04), LDL-C (p = 0.05) and SBP (p = 0.02) significantly were decreased in the intervention group. The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
CONCLUSIONS


Overall, the results of this study demonstrated that the extract of Berberis Integerrima had beneficial effects on metabolic profile and anthropometric indices in RA patients.",2020,"The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
","['active rheumatoid arthritis patients', 'RA patients', '70 active RA patients', 'patients with RA']","['placebo', '6 capsules of 500 mg barberry extract or placebo', 'hydroalcoholic extract of Berberis Integerrima']","['hip circumference', 'weight, BMI, and conicity index', 'blood lipids, blood pressure and obesity', 'Serum levels of fasting blood sugar (FBS), triglyceride (TG), LDL cholesterol (LDL-C) and HDL cholesterol (HDL-C), systolic and diastolic blood pressure and anthropometric factors', 'metabolic profile and anthropometric indices', 'anthropometric indices and metabolic profile', 'FBS', 'LDL-C', 'SBP', 'Waist and hip circumference', 'body fat percent']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0873066', 'cui_str': 'Barberry Extract'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0949843', 'cui_str': 'Barberry'}]","[{'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",70.0,0.376301,"The results showed a significant decrease in body fat percent (p = 0.05), hip circumference (p < 0.001), FBS (p = 0.03) and HDL-C (p = 0.03) in the intervention group compared to the placebo.
","[{'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: aryaeian.n@iums.ac.ir.'}, {'ForeName': 'Sara Khorshidi', 'Initials': 'SK', 'LastName': 'Sedehi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Khorshidi.nutritionist@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Khorshidi', 'Affiliation': ""Student Research Committee, Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran; Pediatric Gastroenterology, Hepatology and Nutrition Research Center, Research Institute for Children Health, Mofid Children's Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Khorshidi.2065@gmail.com.""}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Zarezadeh', 'Affiliation': 'Department of Clinical Nutrition, Student Research Committee, Nutrition Research Center, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Zarezadehm@tbzmed.ac.ir.'}, {'ForeName': 'AghaFatemeh', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: hosseini_f@tums.ac.ir.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shahram', 'Affiliation': 'Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shahramf@tums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102331']
1155,32444038,The effect of Benson's relaxation response on sleep quality and anorexia in cancer patients undergoing chemotherapy: A randomized controlled trial.,"BACKGROUND AND OBJECTIVES


Patients with cancer experience many side effects due to its nature and usual treatments. Sleep disorders and anorexia are the most commonly reported symptoms in cancer patients undergoing chemotherapy. The present study aimed to investigate the effect of Benson's Relaxation Response (BRR) on sleep quality and anorexia in cancer patients undergoing chemotherapy.
METHODOLOGY AND PARTICIPANTS


In the present clinical trial, a total of 84 patients were enrolled and randomly divided into two groups of experimental and control. Benson's relaxation response was administered to the experimental group twice a day over 5 consecutive days. Data was collected using St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS).
RESULTS


The results of our study showed a significant improvement in the sleep quality in the experimental group at 24 (p = 0.02) and 48 (p = 0.001) hours after the intervention compared to the control group. Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group. No side effects were reported during the study and follow-up period.
CONCLUSION


Benson's relaxation response as a complementary method may improve sleep quality and anorexia in cancer patients undergoing chemotherapy. Further studies with greater sample size and longer follow-up period are needed to confirm the current findings.",2020,Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group.,"['84 patients', 'Patients with cancer experience', 'cancer patients undergoing chemotherapy']","[""Benson's Relaxation Response (BRR"", ""Benson's relaxation response""]","['sleep quality and anorexia', 'Sleep disorders and anorexia', 'anorexia', ""St. Mary's Hospital Sleep Questionnaire (SMHSQ) and anorexia questionnaire with Visual Analog Scale (VAS"", 'relaxation response (BRR', 'sleep quality', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",84.0,0.027634,Benson's relaxation response (BRR) also had a significant effect on the anorexia in the experimental group at 24 (7.5 ± 1.6) and 48 (6.9 ± 2.1) hours after the intervention compared to the control group.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran; Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Iran. Electronic address: F_davodabady@arakmu.ac.ir.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Farahani', 'Affiliation': 'Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: z.f.h.nursing@gmail.com.'}, {'ForeName': 'Ali Khanmohamadi', 'Initials': 'AK', 'LastName': 'Hezave', 'Affiliation': 'Student Research Committee, Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: alikhan.nurse@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: f.rafiei87@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102344']
1156,32444040,"Mineral rich algae with pine bark improved pain, physical function and analgesic use in mild-knee joint osteoarthritis, compared to Glucosamine: A randomized controlled pilot trial.","INTRODUCTION


Osteoarthritis (OA) is characterised by synovial joint pain, functional disability and affects ∼13 % of people worldwide, of which ∼16-27 % report Knee-OA (KOA). Glucosamine (Glu) is the most widely used nutraceutical treatment for OA despite a lack of scientific consensus, therefore alternative nutraceutical treatments are required. The aim of this study was to investigate the effect of Lithothamnion species, seawater-derived magnesium and pine bark (Aq + ) on pain, symptoms and improve physical function in symptomatic (sKOA), compared to Glu.
METHODS


358 participants were screened. In a double-blinded crossover pilot-trial, sKOA participant (n = 30) were randomly assigned to either the Glu group (2000 mg day -1 ) or Aq +  (3056 mg day -1 ) for 12 weeks (clinicaltrials.gov:NCT03106584). The Knee Injury and Osteoarthritis Outcome Score was used to assess subjective pain and symptoms. Timed-up-and-Go (TuG) and Six minute walking distance were used to assess functional change and analgesic use was recorded.
RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06). Only Aq +  improved pain (P < 0.05) for males (d' = 0.91, 95 %CI 0.162-1.667) and females (d' = 0.55, 95 %CI 0.210-1.299). In females, Aq +  improved TuG by -7.02 % (d' = 0.92, 95 %CI 1.699-0.141) while Glu worsened performance by 4.18 % (P = 0.04). Aq +  reduced analgesia by 71.6 %, compared to Glu (P = 0.02; d' = 0.82, 95 %CI 1.524-0.123). Aq +  was superior to Glu at improving pain, KOOS subscales, physical function and analgesia use in mild-sKOA. Given these data, Aq +  should be considered as a supplementary treatment for early-stage-KOA and may have the potential to reduce use of pain medication, although larger replication studies are required.",2020,"RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06).","['participant (n = 30', '358 participants were screened', 'symptomatic (sKOA', 'mild-knee joint osteoarthritis']","['Glucosamine', 'sKOA', 'Mineral rich algae with pine bark', 'Lithothamnion species, seawater-derived magnesium and pine bark (Aq + ', 'Glucosamine (Glu', 'Glu group (2000 mg day -1 ) or Aq ']","['pain, physical function and analgesic use', 'Knee Injury and Osteoarthritis Outcome Score', 'analgesia', 'pain, symptoms and improve physical function', 'pain', 'subjective pain and symptoms', 'TuG', 'pain, KOOS subscales, physical function and analgesia use in mild-sKOA']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0330186', 'cui_str': 'Pinus'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",30.0,0.219278,"RESULTS


Aq +  improved pain, with a large effect (P < 0.01, d' = 0.73, 95 %CI 0.201-1.265) and no change for Glu (d' = 0.38, P = 0.06).","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Heffernan', 'Affiliation': 'Applied Sports Science Technology and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK. Electronic address: s.m.heffernan@swansea.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland; Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eustace', 'Affiliation': 'Cappagh National Orthopaedic Hospital, Dublin, Ireland.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'FitzPatrick', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Vito', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102349']
1157,32449277,Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation.,"BACKGROUND


Constipated patients remain dissatisfied with current treatments suggesting a need for alternative therapies.
AIM


Evaluate the mechanistic effects of oral vibrating capsule in chronic idiopathic constipation (CIC) by examining the temporal relationships between the onset of vibrations, complete spontaneous bowel movements (CSBM), and circadian rhythm.
METHODS


In post hoc analyses of two double-blind studies, CIC patients (Rome III) were randomized to receive 5 active or sham capsules/week for 8 weeks. The capsules were programmed for single vibration (study 1) or two vibration sessions with two modes, 8 hours apart (study 2). Daily electronic diaries assessed stool habit and percentage of CSBMs associated with vibrations. Responders were patients with ≥ 1 CSBM per week over baseline.
RESULTS


250 patients were enrolled (active = 133, sham = 117). During and within 3 hours of vibration, there were significantly more % CSBMs in the active vs. sham group (50% vs. 42%; P = .0018). In study 2, there were two CSBM peaks associated with vibration sessions. Significantly more % CSBMs occurred in active mode 1 (21.5%) vs. sham (11.5%); (P = .0357). Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75). Device was well-tolerated barring mild vibration sensation.
CONCLUSIONS


Vibrating capsule may increase CSBMs possibly by enhancing the physiologic effects of waking and meals, and augmenting circadian rhythm, although responder rate was not different from sham. Two vibration sessions were associated with more CSBMs.",2020,"Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75).","['250 patients were enrolled (active\xa0=\xa0133, sham\xa0=\xa0117', 'CIC patients (Rome III', 'chronic idiopathic constipation', 'chronic idiopathic constipation (CIC']","['oral vibrating capsule', 'vibrating capsule']","['Responder rates', 'CSBMs', 'Daily electronic diaries assessed stool habit and percentage of CSBMs', 'colonic circadian rhythm and bowel symptoms']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",250.0,0.356394,"Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75).","[{'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Augusta University Medical Center, Augusta, GA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Friedenberg', 'Affiliation': 'Great Lakes Gastroenterology Research, Mentor, OH, USA.'}, {'ForeName': 'Eamonn M M', 'Initials': 'EMM', 'LastName': 'Quigley', 'Affiliation': 'Lynda K and David M Underwood Center for Digestive Disorders, Houston Methodist Hospital, Weill Cornell Medical College, Houston, TX, USA.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13890']
1158,32456170,Acute Effects of a Short Bout of Physical Activity on Cognitive Function in Sport Students.,"Physical activity is a promising intervention to restore cognitive function after prolonged sedentary periods. However, little is known about the effect of short physical activity bouts on cognition especially among individuals that are used to physical activity. Therefore, the goal of the present study was to assess the impact of a single ten-minute physical activity bout on the cognitive domain of visual attention compared to sedentary behavior in a population of physically active sport students. Using a randomized controlled design, 51 healthy and physically active sport students [mean age: 22.3 (SD: 2.0) years, 33.3% female] were allocated to one of the following interventions in the break of a two-hour study course: physical activity group (running for ten minutes) and sedentary control group. Visual attention was measured post-intervention using a modified trail making test. Pre-, post-, and 30 min after intervention, perceived attention, and affective states were measured. Between-group comparisons were used to analyze whether visual attention and/or changes in perceived attention or affective states differed between groups. The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group,  p  = 0.003,  d  = 0.89. Perceived attention,  p  = 0.006,  d  = 0.87, and arousal,  p  < 0.001,  d  = 1.68, showed a significantly larger pre- and post-intervention increase in the physical activity group compared with the sedentary control group, which was not evident 30 min after intervention. A single ten-minute running intervention in study breaks might help to restore the basal visual attentional domain of cognition after prolonged sedentary periods more effectively compared with common sedentary behavior in breaks between study lessons.",2020,"The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group,  ","['population of physically active sport students', 'Sport Students', '51 healthy and physically active sport students [mean age: 22.3 (SD: 2.0) years, 33.3% female']","['physical activity group (running for ten minutes) and sedentary control group', 'Short Bout of Physical Activity']","['visual attention and/or changes in perceived attention or affective states', 'basal visual attentional domain of cognition', 'visual attention', 'perceived attention, and affective states', 'Cognitive Function', 'Visual attention']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",51.0,0.061781,"The physical activity group showed significantly higher visual attention post-intervention compared with the sedentary control group,  ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Steidl-Müller', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17103678']
1159,32574657,The Feasibility and Acceptability of a Cognitive Behavioral Therapy-Based Intervention for Patients With Advanced Colorectal Cancer.,"CONTEXT


Advanced colorectal cancer and its treatment can bring about challenges associated with psychological distress.
OBJECTIVES


The primary aims of this study were to examine the feasibility and acceptability of a cognitive behavioral therapy (CBT)-based intervention to improve coping with the disease. The secondary aim is to evaluate preliminary intervention efficacy.
METHODS


Patients with advanced colorectal cancer in Singapore (N = 60) were randomized to either receive a four-session CBT intervention immediately or be waitlisted. Intervention feasibility (i.e., recruitment and intervention adherence) and acceptability (i.e., participant satisfaction and cultural sensitivity) were assessed. Changes in psychological distress and self-efficacy were examined.
RESULTS


The study successfully recruited the intended sample (mean age 61; 62% men). A proportion (12%) reported Hospital Anxiety and Depression Scale scores indicative of distress at baseline. Most (88%) completed all sessions. Participants reported high rates of satisfaction (97%), helpfulness (96%), and cultural sensitivity (95%) of the intervention. The intervention group did not show decrease in psychological distress; however, self-efficacy in cancer-related coping (information seeking: effect size [ES] = 0.64; 95% CI = 0.17, 0.85; coping with side effects: ES = 0.69; 95% CI = 0.33, 0.82; and maintaining positive attitude: ES = 0.45; 95% CI = 0.19, 0.79) increased in the intervention group compared with the waitlisted group.
CONCLUSION


The CBT-based intervention was feasible and acceptable to patients in Singapore. There is no sufficient evidence to warrant a larger trial in this sample with low baseline distress. Future work should identify and target those who are most in need of support.",2020,"The intervention group did not show decrease in psychological distress; however, self-efficacy in cancer-related coping (information seeking, effect size (ES) = 0.64, 95%CI [0.17, 0.85]; coping with side effects, ES=0.69, 95%CI [0.33, 0.82]; and maintaining positive attitude, ES=0.45, 95%CI [0.19, 0.79]) increased in the intervention group compared to the waitlisted group.
","['Patients with advanced colorectal cancer in Singapore (N = 60', 'The study successfully recruited the intended sample (M age = 61, 62% men', 'Patients with Advanced Colorectal Cancer']","['Cognitive Behavioral Therapy-based intervention', 'cognitive behavioral therapy (CBT)-based intervention', '4-session CBT intervention immediately or be waitlisted']","['Intervention feasibility (i.e., recruitment and intervention adherence) and acceptability (i.e., participant satisfaction and cultural sensitivity', 'psychological distress and self-efficacy', 'cultural sensitivity', 'feasibility and acceptability', 'rates of satisfaction', 'Hospital Anxiety and Depression Scale (HADS) scores indicative of distress', 'self-efficacy in cancer-related coping (information seeking, effect size (ES', 'psychological distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",60.0,0.0706234,"The intervention group did not show decrease in psychological distress; however, self-efficacy in cancer-related coping (information seeking, effect size (ES) = 0.64, 95%CI [0.17, 0.85]; coping with side effects, ES=0.69, 95%CI [0.33, 0.82]; and maintaining positive attitude, ES=0.45, 95%CI [0.19, 0.79]) increased in the intervention group compared to the waitlisted group.
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Teo', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Department of Psychosocial Oncology, National Cancer Centre Singapore, Singapore; Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore. Electronic address: irene.teo@duke-nus.edu.sg.'}, {'ForeName': 'Yee Pin', 'Initials': 'YP', 'LastName': 'Tan', 'Affiliation': 'Department of Psychosocial Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Grace Meijuan', 'Initials': 'GM', 'LastName': 'Yang', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore; Division of Supportive and Palliative Care, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Fang Ting', 'Initials': 'FT', 'LastName': 'Pan', 'Affiliation': 'Lien Centre for Palliative Care, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Henry Yuen Foong', 'Initials': 'HYF', 'LastName': 'Lew', 'Affiliation': 'Department of Psychology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Emile Kwong Wei', 'Initials': 'EKW', 'LastName': 'Tan', 'Affiliation': 'Department of Colorectal Surgery, Singapore General Hospital, Singapore.'}, {'ForeName': 'Simon Yew Kuang', 'Initials': 'SYK', 'LastName': 'Ong', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Yin Bun', 'Initials': 'YB', 'LastName': 'Cheung', 'Affiliation': 'Programme in Health Services & Systems Research, Duke-NUS Medical School, Singapore; Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore; Centre for Child Health Research, Tampere University, Finland.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.016']
1160,32584168,"The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial.","Rationale:  In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. Objectives:  To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization. Methods:  Exacerbations and change from baseline in trough FEV 1  and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days. Measurements and Main Results:  FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction;  P  < 0.001), but only a numerical reduction was seen among prior ICS nonusers (12% reduction;  P  = 0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce the annual on-treatment moderate/severe exacerbation rate (19%;  P  < 0.001) compared with UMEC/VI. The benefit of FF/UMEC/VI compared with UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users, 35% reduction;  P  < 0.001; non-ICS users, 35% reduction;  P  = 0.018), and overall when excluding the first 30 days (29%;  P  < 0.001). Improvements from baseline with FF/UMEC/VI compared with UMEC/VI were also maintained throughout the study for both trough FEV 1  and St. George's Respiratory Questionnaire, regardless of prior ICS use. Conclusions:  These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.Clinical trial registered with www.clinicaltrials.gov (NCT02164513).",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, Research and Development, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Medical Department, Pulmonary Section, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC']
1161,32438988,Frequency and Impact of Bleeding on Outcome in Patients With Cardiogenic Shock.,"OBJECTIVES


This study sought to determine frequency, associated factors, and impact of bleeding in infarct-related cardiogenic shock.
BACKGROUND


Early revascularization is associated with improved survival in patients with acute myocardial infarction complicated by cardiogenic shock. On the downside, invasive treatment and accompanying antithrombotic therapies are associated with an increased bleeding risk. Prospective data assessing the incidence, severity, risk factors, and prognostic implication of bleeding in patients with cardiogenic shock are scarce.
METHODS


As a pre-defined subanalysis of the CULPRIT-SHOCK (PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock) randomized trial, we examined distribution of bleeding events in 684 patients with infarct-related cardiogenic shock and compared patients with any bleeding to those without.
RESULTS


A total of 21.5% patients experienced at least 1 bleeding event until 30 days after randomization. The vast majority of bleeding (57%) occurred within the first 2 days of hospitalization. Patients with bleeding had prolonged catecholamine treatment and mechanical ventilation and there was a significant association with sepsis, peripheral ischemic complications, new atrial fibrillation, and ventricular fibrillation. In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001). Treatment with active mechanical support by extracorporeal membrane oxygenation or Impella emerged as the major risk factor for bleeding.
CONCLUSIONS


Risk of bleeding in infarct-related cardiogenic shock is high and associated with increased mortality.",2020,"In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001).","['684 patients with infarct-related cardiogenic shock and compared patients with any bleeding to those without', 'Patients with Acute Myocardial Infarction and Cardiogenic Shock', 'patients with acute myocardial infarction complicated by cardiogenic shock', 'patients with cardiogenic shock are scarce', 'Patients With Cardiogenic Shock']",['CULPRIT-SHOCK (PCI Strategies'],"['bleeding risk', 'mortality', 'sepsis, peripheral ischemic complications, new atrial fibrillation, and ventricular fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}]",684.0,0.0720031,"In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001).","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Leipzig Heart Institute, Leipzig, Germany. Electronic address: anne.freund@medizin.uni-leipzig.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jobs', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'ACTION Study Group, Centre Hospitalier Universitaire Pitié-Salpêtrière, Sorbonne Université, Paris, France.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Cardiology, Wilhelminenspital, Sigmund Freud University Medical School, Vienna, Austria.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'Center of Intensive Internal Medicine, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany; Medizinische Klinik B, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Stiftung Institut für Herzinfarktforschung, Ludwigshafen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at the University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig, Germany; German Center for Cardiovascular Research, partner site Hamburg/Kiel/Lübeck, Lübeck, Germany; Department of Cardiology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.02.042']
1162,32444041,The effect of vitamin C supplementation in the last month of pregnancy on neonatal bilirubin levels; A double-blind randomized clinical trial.,"OBJECTIVES


Jaundice is a typical condition in the neonatal period, particularly in the Asian continent. Drowsiness and disruption of breastfeeding, behavioral and neurological disorders, hearing loss and mental retardation are the results of impairment in controlling it. The increase in oxidant substances can stimulate the heme oxygenase enzyme and increase the conversion of heme to bilirubin. In some studies, vitamin C levels in the blood of infants with hyperbilirubinemia were lower than in healthy infants.
DESIGN


In this double-blind clinical trial study, 144 healthy pregnant women aged 20-40 years who were in 34th weeks of gestation were randomly divided into intervention, and control groups and until the end of pregnancy, they took a 500 mg tablet of vitamin C or placebo (Preparation of starch) daily. Demographic information, dietary intake, and physical activity level of the participants were also evaluated. The total blood bilirubin level was measured on the fifth day after birth using a sample of the neonatal heel. Statistical analysis was performed using SPSS software version 22. In this study P-value < 0. 05 was considered significant.
RESULTS


Of the 144 participants, 128 of them completed the intervention. There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
CONCLUSION


Vitamin C supplementation in the last month of pregnancy had a significant effect on neonatal bilirubin level and decreased it significantly.",2020,"There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
","['144 participants', '144 healthy pregnant women aged 20-40 years who were in 34th weeks of gestation']","['vitamin C or placebo (Preparation of starch) daily', 'Vitamin C supplementation', 'vitamin C supplementation']","['Drowsiness and disruption of breastfeeding, behavioral and neurological disorders, hearing loss and mental retardation', 'total blood bilirubin level', 'neonatal bilirubin level', 'Demographic information, dietary intake, and physical activity level', 'vitamin C levels', 'neonatal bilirubin levels', 'conversion of heme to bilirubin', 'level of vitamin C intake through diet, and anthropometric indices', 'oxidant substances', 'total bilirubin level']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0020796', 'cui_str': 'Profound intellectual disability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0863174', 'cui_str': 'Blood bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0018966', 'cui_str': 'Heme'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0564420', 'cui_str': 'Vitamin C intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}]",144.0,0.122377,"There was no significant difference between the two groups at the level of vitamin C intake through diet, and anthropometric indices, but the total bilirubin level in the neonates of the two groups was statistically different (P = 0.02).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khadem Al-Hosseini', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Rahideh', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saadati', 'Affiliation': 'Pediatric Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rahmati', 'Affiliation': 'Department of Obstetrics and Gynecology, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Azadeh', 'Affiliation': 'Health Deputy, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shidfar.f@iums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102359']
1163,32444045,The effect of the Mediterranean diet on cognitive function in patients with Parkinson's disease: A randomized clinical controlled trial.,"OBJECTIVES


Parkinson's disease (PD) is the second most common neurodegenerative disorder. It is proposed that adherence to the Mediterranean diet might have a beneficial effect on the prevention and treatment of PD and its complications. Thus, the aim of this study was to investigate the effects of the Mediterranean diet on cognitive function in patients with PD.
DESIGN


The study was a single-center, randomized clinical trial. Eighty patients with idiopathic PD were randomly allocated to the Mediterranean diet (n = 40) or control (n = 40) group. Patients in the intervention group received an individualized dietary plan based on Mediterranean diet for 10 weeks. The Persian version of Montreal Cognitive Assessment (MoCA) test was used to assess the cognitive function at baseline and the end of the study.
RESULTS


Thirty-five PD patients with a mean age of 59.3 ± 8.3 and 35 patients with a mean age of 58.6 ± 9.3 finished the study in intervention and control groups, respectively. After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all). Nevertheless, the mean of the other scores including spatial-visual ability, memory learning task, and navigation versus time and place did not significantly change in both intervention and control groups.
CONCLUSIONS


The findings of this study showed that adherence to the Mediterranean diet remarkably increased the dimensions of executive function, language, attention, concentration, and active memory and finally the total score of cognitive assessment in PD patients.",2020,"After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all).","[""patients with Parkinson's disease"", 'Eighty patients with idiopathic PD', 'patients with PD', ""Parkinson's disease (PD"", 'Thirty-five PD patients with a mean age of 59.3\u202f±\u202f8.3 and 35 patients with a mean age of 58.6\u202f±']","['individualized dietary plan based on Mediterranean diet', 'Mediterranean diet']","['Persian version of Montreal Cognitive Assessment (MoCA) test', 'cognitive function', 'dimensions of executive function, language, attention, concentration, and active memory and finally the total score of cognitive assessment', 'mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment', 'spatial-visual ability, memory learning task, and navigation versus time and place']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",80.0,0.0280924,"After the intervention, the mean score of the dimensions of executive function, language, attention, concentration, and active memory and the total score of cognitive assessment significantly increased in the intervention compared with the control group (p < 0.05, for all).","[{'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: paknahad@hlth.mui.ac.ir.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sheklabadi', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Yeganeh', 'Initials': 'Y', 'LastName': 'Derakhshan', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Chitsaz', 'Affiliation': 'Professor of Neurology Isfahan University of Medical Sciences, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102366']
1164,32444056,"The effects of licorice containing diphenhydramine solution on recurrent aphthous stomatitis: A double-blind, randomized clinical trial.","OBJECTIVES


The aim of this study was to compare the efficacy of the diphenhydramine solution (DS) and diphenhydramine-containing glycyrrhiza glabra (DSG) in the treatment of recurrent aphthous stomatitis (RAS).
DESIGN


It was a double-blind randomized clinical trial that was conducted from July to September 2018 at the Faculty of Dentistry, Birjand University of Medical Sciences, Birjand, Iran.
INTERVENTION


DSG was made by adding 5% hydroethanolic extract of licorice to the diphenhydramine elixir. A total of 70 patients diagnosed with RSA were randomly assigned to the DS and DSG groups, each containing 35 patients. Participants were instructed to swish 3 ml of either solution around their mouth for about three minutes four times a day (at least 20 min before each meal and before bedtime) until the complete healing of the oral lesions.
MAIN OUTCOME MEASURES


The primary outcome of this study was to assess the severity of pain prior to the intervention and on the first, third, and fifth days of it. This was done using the visual analog scale (VAS). The duration of wound healing was also measured through photography. The secondary outcome was to record the adverse effects of the intervention. This trial was registered at the Iranian Registry of Clinical Trials under number 1  IRCT20180407039213N1.
RESULTS


The average pain score before the treatment in the DS and DSG groups was 8. 1 ± 1.17 and 7.97 ± 1.72, respectively, and there was apparently no significant difference between them. However, there was a significant difference between the two groups in terms of the average pain scores on the first (7 ± 1.28 versus 5.31 ± 1.28), third (4.02 ± 1.8 vs. 2.86 ± 1.56) and fifth days (1.71 ± 1.69 vs. 0.54 ± 1.31) of the intervention. Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001). No adverse effects were observed with the intervention.
CONCLUSION


According to our results, DSG appeared to be more effective in treating RAS than DS alone.
TRIAL REGISTRATION


The trial was registered at Iranian Registry of Clinical Trials before the enrolment of the first patient on June 29, 2019 (registration no: IRCT20180407039213N1, http://www.irct.ir/trial/31497).",2020,"Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001).","['was conducted from July to September 2018 at the Faculty of Dentistry, Birjand University of Medical Sciences, Birjand, Iran', 'recurrent aphthous stomatitis (RAS', '70 patients diagnosed with RSA']","['licorice containing diphenhydramine solution', 'diphenhydramine solution (DS) and diphenhydramine-containing glycyrrhiza glabra (DSG', 'DS and DSG']","['visual analog scale (VAS', 'severity of pain prior to the intervention and on the first, third, and fifth days of it', 'average wound healing duration', 'recurrent aphthous stomatitis', 'average pain score', 'average pain scores', 'duration of wound healing', 'adverse effects']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0284559', 'cui_str': 'gusperimus'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",70.0,0.19952,"Indeed, DSG significantly reduced the average wound healing duration by 1.5 days, as compared to DS (P = 0.0001).","[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Akbari', 'Affiliation': 'Faculty of Dentistry, Birjand University of Medical sciences, Birjand, Iran. Electronic address: narges.akbare4021@yahoo.com.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Asadimehr', 'Affiliation': 'Faculty of Dentistry, Birjand University of Medical sciences, Birjand, Iran. Electronic address: n.asadi137339@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Kiani', 'Affiliation': 'Pharmacology Department, Medical School, Birjand University of Medical Sciences, Birjand, 9717853577, Iran. Electronic address: kiani.za@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102401']
1165,32444057,Effects of a short-term mindfulness-based stress reduction program on the quality of life of women with infertility: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


Although some programs based on mindfulness-based stress reduction (MBSR) have been suggested to promote quality of life (QoL) in different conditions, limited studies have addressed their potential effects in women with infertility. In this study, we aimed to determine the effects of an MBSR program on the QoL of women with infertility.
MATERIALS AND METHODS


This randomized controlled clinical trial was conducted on 36 women with infertility, who were selected by consecutive sampling from the Infertility Center of Ahvaz Imam Khomeini Hospital, Iran. Women either participated in the MBSR program or received routine consultation in eight two-hour group sessions once a week. Women's QoL was measured using the 36-item short-form health survey before, immediately after, and one month after the intervention. The intention-to-treat analysis, with multiple imputation for missing data, was also performed.
RESULTS


The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases). Twenty four and six adverse events were recorded in the experimental and control groups, respectively.
CONCLUSION


Short-term MBSR program seem to be potentially effective in improving the QoL of women with infertility. Further studies are needed to determine the generalizability of our findings.",2020,"The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases).","['women with infertility', '36 women with infertility, who were selected by consecutive sampling from the Infertility Center of Ahvaz Imam Khomeini Hospital, Iran', 'Women either participated in the MBSR program or received']","['MBSR program', 'short-term mindfulness-based stress reduction program', 'routine consultation']","['quality of life', 'total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",36.0,0.0481449,"The mean changes in the total score of QoL and its subscales (except for ""social functioning"" and ""bodily pain"") were significant compared to the baseline both at immediately after and one month after the intervention in favor of the experimental group (P<0.001 in most cases).","[{'ForeName': 'Masoumeh Sadat', 'Initials': 'MS', 'LastName': 'Hosseini', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Masoumehsadat.hosseini@yahoo.com.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Mousavi', 'Affiliation': 'Reproductive Health Promotion Research Center, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Mousavip2009@yahoo.com.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Hekmat', 'Affiliation': 'Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Reproductive Health Promotion Research Center, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Hekmat1346@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Johari Fard', 'Affiliation': 'Department of Psychology, Islamic Azad University, Ahvaz Branch, Ahvaz, Iran. Electronic address: Rjoharifard@gmail.com.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Mohammad Jafari', 'Affiliation': 'Fertility, Infertility and Perinatology Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Rmj41@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102403']
1166,32451288,Efficacy and adherence of sublingual immunotherapy in patients aged 60 to 75 years old with house dust mite-induced allergic rhinitis.,"PURPOSE


This study aimed to evaluate the efficacy and adherence of sublingual immunotherapy (SLIT) for house dust mite (HDM)-induced allergic rhinitis (AR) patients over 60 years old.
MATERIALS AND METHODS


Eighty-six AR patients aged 60-75 years old were randomly divided in the control and treatment group as 1:1 ratio. The control group was treated with standard pharmacotherapy while the treatment group was treated with SLIT plus pharmacotherapy on demand. Patients adherence, combined symptom and medication score (CSMS), visual analog scale (VAS), and presence of adverse events were evaluated in the baseline and after 6-months, 12-months and 24-months treatment.
RESULTS


Twenty-five (58.1%) subjects in the treatment group and 20 (46.5%) subjects in the control group completed the study (P > 0.05). The major reasons for premature cessation were out of touch and relieved symptoms. At the same time, CSMS and VAS of the patients over 60 years old in both groups significantly decreased from baseline to any post-baseline time point (all P < 0.05). The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05).
CONCLUSION


41.9% of the patients dropped out within 2 years of SLIT treatment and the major reasons for premature cessation were out of touch and relieved symptoms. This study suggested that SLIT plus pharmacotherapy provided a greater clinical benefit than pharmacotherapy alone at two years.",2020,"The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05).
","['house dust mite (HDM)-induced allergic rhinitis (AR) patients over 60\xa0years old', 'Eighty-six AR patients aged 60-75\xa0years old', 'patients aged 60 to 75\xa0years old with house dust mite-induced allergic rhinitis']","['sublingual immunotherapy', 'sublingual immunotherapy (SLIT', 'standard pharmacotherapy', 'SLIT plus pharmacotherapy']","['Patients adherence, combined symptom and medication score (CSMS), visual analog scale (VAS), and presence of adverse events', 'CSMS and VAS', 'Efficacy and adherence']","[{'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",86.0,0.0113207,"The comparison of CSMS and VAS between the two groups revealed statistically significant differences in favor of the SLIT group at month 24 (P < 0.05), whereas no differences at month 6 and month 12 (all P > 0.05).
","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Biyu', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Shaopeng', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Qinhua', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China.'}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Fujian Provincial Hospital, Fuzhou 350001, China. Electronic address: liruiyu_phd@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102538']
1167,32458035,Simultaneous single-stage versus two-staged bilateral total knee arthroplasty: a prospective comparative study.,"PURPOSE


The study aims to prospectively compare peri-operative morbidity and mortality of simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA) performed within 12 months of the first surgery. We hypothesized that SS BLTKA is as safe as TS BLTKA.
METHODS


Patients with a minimum follow-up of 12 months were included in this study. Oxford knee score and quality of life index SF12 was compared between the 2 groups at six weeks and six month follow-up.
RESULTS


SS BLTKA included 250 patients and TS BLTKA included 210 patients. The minimum time interval between two operations was three weeks (mean 1.6 months, range 3 weeks-12 months). There was no significant difference between the 2 groups in peri-operative mortality, surgical site infection, major peri-operative complications. There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up. There was no difference in the range of knee flexion between the 2 groups at six months. Post-operative haemoglobin drop was significantly more in SS BLTKA patients and consequently, blood transfusion requirement was significantly higher in SS BLTKA. There was a significantly higher length of hospital stay and duration of surgery in TS BLTKA group.
CONCLUSION


There does not appear to be a difference in complication rates between the 2 groups. SS BLTKA seems to be a logical choice if both knees have severe osteoarthritis. Patients with severe cardiopulmonary compromise were excluded, and a unilateral procedure may be preferred in them.",2020,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"['Patients with severe cardiopulmonary compromise', 'Patients with a minimum follow-up of 12\xa0months', '250 patients and TS BLTKA included 210 patients']","['Simultaneous single-stage versus two-staged bilateral total knee arthroplasty', 'simultaneous single-stage bilateral total knee arthroplasty (SS BLTKA) with two-staged bilateral total knee arthroplasty (TS BLTKA']","['blood transfusion requirement', 'length of hospital stay and duration of surgery', 'complication rates', 'peri-operative mortality, surgical site infection, major peri-operative complications', 'minimum time interval', 'Oxford knee score and quality of life index SF12', 'range of knee flexion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0576095', 'cui_str': 'Range of knee flexion'}]",250.0,0.0426341,There was no difference between the 2 groups in the Oxford knee score and quality of life index SF12 at 6-month follow-up.,"[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Goyal', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Bathinda, Punjab, 151001, India. goyal.tarun@gmail.com.'}, {'ForeName': 'Md Quamar', 'Initials': 'MQ', 'LastName': 'Azam', 'Affiliation': 'Department of Trauma Surgery, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Department of Radiodiagnosis, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, Rishikesh, India.'}]",International orthopaedics,['10.1007/s00264-020-04642-6']
1168,32580883,"Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial.","BACKGROUND


We aimed to identify a five-fraction schedule of adjuvant radiotherapy (radiation therapy) delivered in 1 week that is non-inferior in terms of local cancer control and is as safe as an international standard 15-fraction regimen after primary surgery for early breast cancer. Here, we present 5-year results of the FAST-Forward trial.
METHODS


FAST-Forward is a multicentre, phase 3, randomised, non-inferiority trial done at 97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK. Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible. We randomly allocated patients to either 40 Gy in 15 fractions (over 3 weeks), 27 Gy in five fractions (over 1 week), or 26 Gy in five fractions (over 1 week) to the whole breast or chest wall. Allocation was not masked because of the nature of the intervention. The primary endpoint was ipsilateral breast tumour relapse; assuming a 2% 5-year incidence for 40 Gy, non-inferiority was predefined as ≤1·6% excess for five-fraction schedules (critical hazard ratio [HR] of 1·81). Normal tissue effects were assessed by clinicians, patients, and from photographs. This trial is registered at isrctn.com, ISRCTN19906132.
FINDINGS


Between Nov 24, 2011, and June 19, 2014, we recruited and obtained consent from 4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule. At a median follow-up of 71·5 months (IQR 71·3 to 71·7), the primary endpoint event occurred in 79 patients (31 in the 40 Gy group, 27 in the 27 Gy group, and 21 in the 26 Gy group); HRs versus 40 Gy in 15 fractions were 0·86 (95% CI 0·51 to 1·44) for 27 Gy in five fractions and 0·67 (0·38 to 1·16) for 26 Gy in five fractions. 5-year incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions). At 5 years, any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall was reported for 98 of 986 (9·9%) 40 Gy patients, 155 (15·4%) of 1005 27 Gy patients, and 121 of 1020 (11·9%) 26 Gy patients. Across all clinician assessments from 1-5 years, odds ratios versus 40 Gy in 15 fractions were 1·55 (95% CI 1·32 to 1·83, p<0·0001) for 27 Gy in five fractions and 1·12 (0·94 to 1·34, p=0·20) for 26 Gy in five fractions. Patient and photographic assessments showed higher normal tissue effect risk for 27 Gy versus 40 Gy but not for 26 Gy versus 40 Gy.
INTERPRETATION


26 Gy in five fractions over 1 week is non-inferior to the standard of 40 Gy in 15 fractions over 3 weeks for local tumour control, and is as safe in terms of normal tissue effects up to 5 years for patients prescribed adjuvant local radiotherapy after primary surgery for early-stage breast cancer.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2020,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"['Between Nov 24, 2011, and June 19, 2014', '4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule', 'Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible', '97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK']","['adjuvant radiotherapy (radiation therapy', 'adjuvant local radiotherapy', 'Hypofractionated breast radiotherapy']","['normal tissue effect risk', 'Normal tissue effects', 'ipsilateral breast tumour relapse', 'moderate or marked clinician-assessed normal tissue effects', '5-year incidence for 40 Gy, non-inferiority', 'incidence of ipsilateral breast tumour relapse']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}]",4096.0,0.236289,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Murray Brunt', 'Affiliation': 'University Hospitals of North Midlands and University of Keele, Stoke on Trent, UK; Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK. Electronic address: fastforward-icrctsu@icr.ac.uk.'}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Haviland', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Duncan A', 'Initials': 'DA', 'LastName': 'Wheatley', 'Affiliation': 'Royal Cornwall Hospital, Treliske, Truro, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Sydenham', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alhasso', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bloomfield', 'Affiliation': 'Brighton and Sussex University Hospitals, Brighton, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Nuffield Health Cheltenham Hospital, Cheltenham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Churn', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cleator', 'Affiliation': 'Imperial Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Coles', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK; Torbay Hospital NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Harnett', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Hopwood', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kirby', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'Zohal', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Sawyer', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Navita', 'Initials': 'N', 'LastName': 'Somaiah', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Liba', 'Initials': 'L', 'LastName': 'Stones', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Bebington, Wirral, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Yarnold', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30932-6']
1169,32469384,Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial.,"Importance


Papillary renal cell carcinoma (PRCC) is the most common type of non-clear cell RCC. Because some cases of PRCC are MET-driven, MET inhibition could be a targeted treatment approach. In previous studies, savolitinib (AZD6094, HMPL-504, volitinib), a highly selective MET-tyrosine kinase inhibitor, demonstrated antitumor activity in this patient group.
Objective


To determine whether savolitinib is a better treatment option for this patient population, vs standard of care, sunitinib.
Design, Setting, and Participants


The SAVOIR phase 3, open-label, randomized clinical trial was a multicenter study carried out in 32 centers in 7 countries between July 2017 and the data cutoff in August 2019. Overall, 360 to 450 patients were to be screened to randomize approximately 180 patients. Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions. Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment. Overall, 254 patients were screened.
Interventions


Patients received 600 mg of savolitinib orally once daily (qd), or 50 mg of sunitinib orally qd for 4 weeks, followed by 2 weeks without treatment.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS, assessed by investigator and confirmed by blinded independent central review). Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability.
Results


At data cutoff, 60 patients were randomized (savolitinib n = 33; sunitinib n = 27); most patients had chromosome 7 gain (savolitinib, 30 [91%]; sunitinib, 26 [96%]) and no prior therapy (savolitinib, 28 [85%]; sunitinib, 25 [93%]). For savolitinib and sunitinib, 4 (12%) and 10 (37%) patients were women, and the median (range) age was 60 (23-78) and 65 (31-77) years, respectively. Following availability of external data on PFS with sunitinib in patients with MET-driven disease, study enrollment was closed. Progression-free survival, OS, and ORR were numerically greater with savolitinib vs sunitinib. Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31). For savolitinib and sunitinib respectively, grade 3 or higher adverse events (AEs) were reported in 14 (42%) and 22 (81%) of patients and AE-related dose modifications in 10 (30%) and 20 (74%). After discontinuation, 12 (36%) and 5 (19%) of patients on savolitinib and sunitinib respectively, received subsequent anticancer therapy.
Conclusions and Relevance


Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy vs sunitinib, with fewer grade 3 or higher AEs and dose modifications. Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT03091192.",2020,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","['360 to 450 patients were to be screened, to randomize approximately 180 patients', 'Importance\n\n\nPapillary renal cell carcinoma ', '32 centers in 7 countries between July 2017 and the data cutoff in August 2019', '60 patients were randomized (savolitinib n\u2009=\u200933', '254 patients were screened', 'Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment', 'patients with MET-driven disease, study enrollment was closed', 'Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions', 'Patients With MET-Driven Papillary Renal Cell Carcinoma']","['PRCC', 'Savolitinib vs Sunitinib']","['progression-free survival (PFS', 'Median PFS', 'overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability', 'Progression-free survival, OS, and ORR']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.307135,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Cancel', 'Affiliation': 'CHU Bretonneau Centre, Tours University, France.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Lone H', 'Initials': 'LH', 'LastName': 'Ottesen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Frigault', 'Affiliation': 'Oncology R&D, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Hernault"", 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szijgyarto', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2218']
1170,32464630,Dynamic Light Scattering: A New Noninvasive Technology for Neonatal Heart Rate Monitoring.,"BACKGROUND


Heart rate (HR) detection in premature infants using electrocardiography (ECG) is challenging due to a low signal amplitude and the fragility of the premature skin. Recently, the dynamic light scattering (DLS) technique has been miniaturized, allowing noninvasive HR measurements with a single sensor.
OBJECTIVE


The aim was to determine the accuracy of DLS for HR measurement in infants, compared to ECG-derived HR.
METHODS


Stable infants with a gestational age of ≥26 weeks, monitored with ECG, were eligible for inclusion. HR was measured with the DLS sensor at 5 different sites for 15 min each. We recorded every 10th second of the DLS-derived HR and the DLS signal-to-noise ratio (SNR), and the ECG-derived HR was extracted for analysis. Patients were randomly divided into 2 groups. In the first group, the optimal SNR cut-off value was determined and then applied to the second group to assess agreement.
RESULTS


HR measurements from 31 infants were analyzed. ECG-DLS paired data points were collected at the forehead, an upper extremity, the thorax, a lower extremity, and the abdomen. When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66). Application of this cut-off to the second group (n = 16) showed good agreement between DLS-derived HR and ECG-derived HR (bias -0.73 bpm; 95% limits of agreement -15.46 and 14.00 bpm) at the forehead with approximately 80% (i.e., 1,066/1,310) of all data pairs remaining.
CONCLUSION


The investigated DLS sensor was sensitive to movement, overall providing less accurate HR measurements than ECG and pulse oximetry. In this study population, specific measurement sites provided excellent signal quality and good agreement with ECG-derived HR.",2020,"When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66).","['premature infants using', 'Stable infants with a gestational age of ≥26 weeks, monitored with ECG, were eligible for inclusion']","['electrocardiography (ECG', 'Dynamic Light Scattering']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0023693', 'cui_str': 'Light'}]",[],31.0,0.0168291,"When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66).","[{'ForeName': 'Norani H', 'Initials': 'NH', 'LastName': 'Gangaram-Panday', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands, n.gangaram-panday@erasmusmc.nl.""}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'van Essen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Goos', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Rogier C J', 'Initials': 'RCJ', 'LastName': 'de Jonge', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Weteringen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}]",Neonatology,['10.1159/000506771']
1171,32443036,Effectivity of Pancreatic Enzyme Replacement Therapy in Malnourished Children.,"OBJECTIVE


Malnutrition is commonly seen in children with exocrine pancreatic insufficiency (EPI). Pancreatic enzyme replacement therapy (PERT) is the mainstay treatment of acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis). The effectiveness of PERT in children with malnutrition without any chronic disease, however, remains unclear. The aim of this study was to investigate the effectiveness of PERT on weight gain and EPI in children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification.
MATERIALS AND METHODS


The study included a total of 40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification. The patients were randomly divided into 2 groups: PERT group (n = 20) received 2000 U lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only. In both groups, anthropometric measurements and the assessment of fecal elastase-1 (FE-1) levels were performed both at first admission and at the end of the 8-week treatment period.
RESULTS


On the basis of WHO classification, 10 (25%) children were classified as severely malnourished and 30 (75%) children as moderately malnourished. EPI was detected in all the patients, among whom 24 (60%) patients had severe EPI. At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels. Similarly, no significant difference was found between pre- and posttreatment measurements of PERT and control groups (P > 0.05) and between pre- and posttreatment measurements of patients with moderate and severe malnutrition (P > 0.05).
CONCLUSIONS


Malnutrition remains a serious public health problem, and thus, the development of novel treatment methods is highly essential. PERT is one of the most commonly considered alternatives, although there is little documentation of PERT in the literature. In the present study, although PERT resulted in higher weight gain, it established no significant difference between the 2 groups.",2020,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","['children classified as moderately and severely malnourished according to the World Health Organization (WHO) classification', 'children with exocrine pancreatic insufficiency (EPI', '40 children aged 2-16 years who were classified as moderately and severely malnourished according to the WHO classification', 'acute malnutrition in children detected with a disease closely associated with EPI (eg, cystic fibrosis', 'Malnourished Children', 'children with malnutrition without any chronic disease']","['2000\u200aU lipase/kg/day (in 4 doses) in addition to hypercaloric enteral supplements and control group received hypercaloric enteral supplements only', 'Pancreatic Enzyme Replacement Therapy', 'Pancreatic enzyme replacement therapy (PERT', 'PERT']","['body weight, height, and body mass index (BMI', 'fecal elastase-1 (FE-1) levels', 'weight gain', 'severe malnutrition', 'severe EPI', 'weight gain and EPI', 'waist circumference (WC) and FE-1 levels', 'EPI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1257753', 'cui_str': 'Malnutrition in Children'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4523842', 'cui_str': 'Pancreatic enzyme replacement therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1272315', 'cui_str': 'Fecal elastase 1 level'}]",40.0,0.0311251,"At the end of the treatment, body weight, height, and body mass index (BMI) increased significantly in both groups compared to their pre-treatment values, whereas no significant difference was found with regard to waist circumference (WC) and FE-1 levels.","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Güven', 'Affiliation': 'Department of Pediatric Gastroenterology, Karadeniz Technical University Faculty of Medicine, Trabzon.'}, {'ForeName': 'Mevsim', 'Initials': 'M', 'LastName': 'Demir Mis', 'Affiliation': 'Department of Pediatrics, Van Yuzuncu Yil University Faculty of Medicine, Van.'}, {'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Karaman', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}, {'ForeName': 'Akkiz', 'Initials': 'A', 'LastName': 'Şahin Yaşar', 'Affiliation': 'Department of Pediatric Heamatology, Van Yuzuncu Yil University Faculty of Medicine, Van, Turkey.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002689']
1172,32444058,Thermo-therapy and cryotherapy to decrease the symptoms of restless leg syndrome during the pregnancy: A randomized clinical trial.,"BACKGROUND AND PURPOSE


Restless legs syndrome (RLS) is a common sensory-motor disorder among the pregnant women. The aim of this study is to compare the impacts of two methods of immersion of legs in cold and warm water on the RLS symptoms among the pregnant women.
METHODS


This randomized clinical trial was conducted on 80 pregnant women with RLS who referred to Taleghani educational-therapy center. After obtaining their informed consent, they were selected by accessible method and randomly allocated into group 1 (warm water) and group 2 (cold water). Group 1 were asked to put their legs in cold water for 10 min every night for 2 weeks. The group 2 put their legs in warm water under the same condition. The severity of RLS was measured before and after the study. Data analysis was conducted using descriptive as well as the analytical statistics such as Chi-square, independent T test, pair T test, Mann-Whitney U, Wilcoxon and covariance.
RESULTS


After intervention, mean RLS of the cold water group was11.02 ± 4.93; while this mean was 13.50 ± 4.74 in the warm water group. The difference between the two groups was significant (p = 0.017). Results also revealed that the severity of RLS symptoms at the end of the treatment was different from the beginning of the research in both groups (p = 0.001). The intervention with both warm and cold water declined the RLS symptoms among pregnant women.
CONCLUSION


The warm and cold water can be used for this purpose depending on the women's preference. However, this article recommends the cold water for more reducing of symptoms.",2020,The difference between the two groups was significant (p = 0.017).,"['80 pregnant women with RLS who referred to Taleghani educational-therapy center', 'pregnant women']",['Thermo-therapy and cryotherapy'],"['severity of RLS', 'mean RLS', 'severity of RLS symptoms', 'symptoms of restless leg syndrome', 'RLS symptoms']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0204583', 'cui_str': 'Educational therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",80.0,0.0644877,The difference between the two groups was significant (p = 0.017).,"[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Jafarimanesh', 'Affiliation': 'School of Nursing, School of Medicine, Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Arak, Sardasht, Iran. Electronic address: Jafarimanesh@arakmu.ac.ir.'}, {'ForeName': 'Katayon', 'Initials': 'K', 'LastName': 'Vakilian', 'Affiliation': 'Department of Midwifery, School of Medicine, Traditional and Complementary Medicine Research Center(TCMRC), Arak University of Medical Sciences, Arak, Sardasht, Iran. Electronic address: dr.kvakilian@arakmu.ac.ir.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Mobasseri', 'Affiliation': 'Traditional and Complementary Medicine Research Center (TCMRC), Arak University of Medical Sciences, Imam Khomeini Street, Taleghani Hospital, Arak, Iran. Electronic address: shirinmobaseri@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102409']
1173,32445952,"Low-Fat, High-Fiber Diet Reduces Markers of Inflammation and Dysbiosis and Improves Quality of Life in Patients With Ulcerative Colitis.","BACKGROUND & AIMS


A high-fat diet has been associated with an increased risk of ulcerative colitis (UC). We studied the effects of a low-fat, high-fiber diet (LFD) vs an improved standard American diet (iSAD, included higher quantities of fruits, vegetables, and fiber than a typical SAD). We collected data on quality of life, markers of inflammation, and fecal markers of intestinal dysbiosis in patients with UC.
METHODS


We analyzed data from a parallel-group, cross-over study of 17 patients with UC in remission or with mild disease (with a flare within the past 18 mo), from February 25, 2015, through September 11, 2018. Participants were assigned randomly to 2 groups and received a LFD (10% of calories from fat) or an iSAD (35%-40% of calories from fat) for the first 4-week period, followed by a 2-week washout period, and then switched to the other diet for 4 weeks. All diets were catered and delivered to patients' homes, and each participant served as her or his own control. Serum and stool samples were collected at baseline and week 4 of each diet and analyzed for markers of inflammation. We performed 16s ribosomal RNA sequencing and untargeted and targeted metabolomic analyses on stool samples. The primary outcome was quality of life, which was measured by the short inflammatory bowel disease (IBD) questionnaire at baseline and week 4 of the diets. Secondary outcomes included changes in the Short-Form 36 health survey, partial Mayo score, markers of inflammation, microbiome and metabolome analysis, and adherence to the diet.
RESULTS


Participants' baseline diets were unhealthier than either study diet. All patients remained in remission throughout the study period. Compared with baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and Short-Form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD, P = .02; baseline vs LFD, P = .001). Serum amyloid A decreased significantly from 7.99 mg/L at baseline to 4.50 mg/L after LFD (P = .02), but did not decrease significantly compared with iSAD (7.20 mg/L; iSAD vs LFD, P = .07). The serum level of C-reactive protein decreased numerically from 3.23 mg/L at baseline to 2.51 mg/L after LFD (P = .07). The relative abundance of Actinobacteria in fecal samples decreased from 13.69% at baseline to 7.82% after LFD (P = .017), whereas the relative abundance of Bacteroidetes increased from 14.6% at baseline to 24.02% on LFD (P = .015). The relative abundance of Faecalibacterium prausnitzii was higher after 4 weeks on the LFD (7.20%) compared with iSAD (5.37%; P = .04). Fecal levels of acetate (an anti-inflammatory metabolite) increased from a relative abundance of 40.37 at baseline to 42.52 on the iSAD and 53.98 on the LFD (baseline vs LFD, P = .05; iSAD vs LFD, P = .09). The fecal level of tryptophan decreased from a relative abundance of 1.33 at baseline to 1.08 on the iSAD (P = .43), but increased to a relative abundance of 2.27 on the LFD (baseline vs LFD, P = .04; iSAD vs LFD, P = .08); fecal levels of lauric acid decreased after LFD (baseline, 203.4; iSAD, 381.4; LFD, 29.91; baseline vs LFD, P = .04; iSAD vs LFD, P = .02).
CONCLUSIONS


In a cross-over study of patients with UC in remission, we found that a catered LFD or iSAD were each well tolerated and increased quality of life. However, the LFD decreased markers of inflammation and reduced intestinal dysbiosis in fecal samples. Dietary interventions therefore might benefit patients with UC in remission. ClinicalTrials.gov no: NCT04147598.",2020,"Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001).","['patients with UC in remission', '17 patients with UC in remission or mild disease (with a flare within the last 18 months), from February 25, 2015 through September 11, 2018', 'Patients', 'patients with UC']","['Low-fat, High-fiber Diet', 'low-fat, high-fiber diet (LFD) vs an improved standard American diet (iSAD', 'LFD (10% of calories from fat) or an iSAD']","['relative abundance of Bacteroidetes', 'quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score', 'Serum amyloid', 'LFD decreased markers of inflammation and reduced intestinal dysbiosis', 'quality of life, markers of inflammation, and fecal markers of intestinal dysbiosis', 'Serum and stool samples', 'risk of ulcerative colitis (UC', 'Inflammation and Dysbiosis and Improves Quality of Life', 'changes in short-form 36 health survey, partial Mayo score, markers of inflammation, microbiome and metabolome analysis, and adherence to the diet', 'Serum level of C-reactive protein', 'Relative abundance of Actinobacteria in fecal samples', 'Relative abundance of Faecalibacterium prausnitzii', 'quality of life, which was measured by the short inflammatory bowel disease (IBD) questionnaire', 'Fecal levels of acetate (an anti-inflammatory metabolite', 'Fecal level of tryptophan', 'fecal levels of lauric acid', 'tolerated and increased quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3697010', 'cui_str': 'Ulcerative colitis in remission'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0301568', 'cui_str': 'High residue diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0301568', 'cui_str': 'High residue diet'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4287543', 'cui_str': 'Intestinal dysbiosis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1550661', 'cui_str': 'Stool specimen'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0600148', 'cui_str': 'Class Actinobacteria'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0317558', 'cui_str': 'Faecalibacterium prausnitzii'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}]",17.0,0.0684843,"Compared to baseline, the iSAD and LFD each increased quality of life, based on the short IBD questionnaire and short-form 36 health survey scores (baseline short IBD questionnaire score, 4.98; iSAD, 5.55; LFD, 5.77; baseline vs iSAD P=.02; baseline vs LFD P=.001).","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fritsch', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Department of Microbiology and Immunology, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garces', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Quintero', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Pignac-Kobinger', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Santander', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Yuguang J', 'Initials': 'YJ', 'LastName': 'Ban', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Deukwoo', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Division of Biostatistics, Department of Public Health Sciences, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Phillips', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Knight', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St Paul, Minnesota.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Santaolalla', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Xi S', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Division of Biostatistics, Department of Public Health Sciences, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mukil', 'Initials': 'M', 'LastName': 'Maruthamuthu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Solis', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Oriana M', 'Initials': 'OM', 'LastName': 'Damas', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Kerman', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Amar R', 'Initials': 'AR', 'LastName': 'Deshpande', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami-Leonard Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St Paul, Minnesota.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Miami-Leonard Miller School of Medicine, Miami, Florida; Department of Microbiology and Immunology, University of Miami-Leonard Miller School of Medicine, Miami, Florida. Electronic address: Mabreu1@med.miami.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.05.026']
1174,32446880,Changes in parental feeding practices and preschoolers' food intake following a randomized controlled childhood obesity trial.,"Childhood obesity treatment involving parents is most effective during the preschool age. However, the mechanisms of change are not known. The present study reports on secondary outcomes (changes in parental feeding practices and child food intake) of early obesity treatment. The More and Less study is a randomized controlled trial conducted in Stockholm County, Sweden. Children with obesity (n = 174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree) were randomized to: 1) standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB). The Child Feeding Questionnaire (CFQ) was used to measure parental feeding practices. Child food intake was assessed with a Food Frequency Questionnaire (FFQ). We calculated the monthly changes in CFQ practices and FFQ items based on four measurements. We did not find any significant between-group differences in parental feeding practices and child food intake over time. However, general linear models showed that changes in certain feeding practices predicted changes in child food intake. When ST was compared to the parent support groups, some associations moved in opposite directions. For example, increasing maternal restriction predicted increased consumption of cookies/buns in PGNB (b = 2.3, p < 0.05) and decreased consumption of cookies/buns in ST (b = -2.1, p < 0.05). This is among the few studies to examine the effect of parental feeding practices on child food intake and weight status after obesity treatment among preschoolers. We found no evidence that changes in feeding practices or changes in child food intake mediated child weight loss. Future studies should consider other intermediary processes related to general parenting practices and parent-child interactions.",2020,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"['Children with obesity (n\u202f=\u202f174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree', 'child food habits and weight status after obesity treatment among preschoolers', 'Stockholm County, Sweden']","['standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB', 'parental feeding practices']","['Food Frequency Questionnaire (FFQ', 'parental feeding practices and child food habits) of early obesity treatment', 'consumption of cookies/buns in ST', 'Child Feeding Questionnaire (CFQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",,0.0264302,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Somaraki', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: maria.somaraki@ikv.uu.se.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Unit for Biocultural Variation and Obesity, School of Anthropology and Museum Ethnography, University of Oxford, Oxford, UK; Social Science and Systems in Health, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. Electronic address: karin.eli@anthro.ox.ac.uk.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Sorjonen', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden. Electronic address: kimmo.sorjonen@ki.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: anna.ek@ki.se.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Sandvik', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: pernilla.sandvik@ikv.uu.se.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden; Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: paulina.nowicka@ikv.uu.se.'}]",Appetite,['10.1016/j.appet.2020.104746']
1175,32453396,"Effects of coadministration of DHA and vitamin E on spermatogram, seminal oxidative stress, and sperm phospholipids in asthenozoospermic men: a randomized controlled trial.","BACKGROUND


It is unknown which compounds in spermatozoa or seminal plasma may be involved in the regulation of sperm motility.
OBJECTIVES


The aim of this study was to investigate the effects of DHA (22:6n-3), vitamin E, and their probable interactions in men with asthenozoospermia.
METHODS


A factorial, randomized, double-blind, placebo-controlled trial was conducted in infertility clinics in Tehran, Iran. The participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function. Their concentration of spermatozoa and percentage of morphologically normal spermatozoa were equal to or above the lower reference limits, according to the fifth edition of the WHO guideline. Out of 717 men referred to the infertility clinics, 180 asthenozoospermic men were randomly assigned to 1 of 4 groups according to stratified blocked randomization by age and sperm concentration. Participants took daily 465 mg DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP) for 12 wk. Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity were measured at baseline and after 12 wk.
RESULTS


After the intervention, mean ± SD sperm progressive motility was greater in the DE group (27.9 ± 2.8) than in the DP (25.7 ± 3.4), EP (26.1 ± 2.8), and PP (25.8 ± 2.6) groups (P < 0.05). Sperm count (P = 0.001) and concentration (P = 0.044) increased significantly in the DE group compared with the other 3 groups, whereas other semen parameters were not significantly different between the groups after the intervention. Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
CONCLUSIONS


Combined DHA and vitamin E supplements led to increased sperm motility; however, no significant changes occurred in sperm morphology and vitality in asthenozoospermic men.This trial was registered at clinicaltrials.gov as NCT01846325.",2020,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","['participants were idiopathic asthenozoospermic men aged 20-45 y, with normal endocrine function', '717 men referred to the infertility clinics, 180 asthenozoospermic men', 'infertility clinics in Tehran, Iran', 'men with asthenozoospermia', 'asthenozoospermic men']","['DHA and vitamin E', 'DHA (22:6n-3), vitamin E', 'DHA and vitamin E supplements', 'DHA plus 600 IU vitamin E (DE), 465 mg DHA plus placebo (DP), 600 IU vitamin E plus placebo (EP), or both placebo capsules (PP', 'placebo']","['Sperm characteristics, oxidative stress of seminal plasma, serum and sperm membrane fatty acids, dietary intakes, anthropometric measurements, and physical activity', 'sperm motility', 'Sperm count', 'Serum concentrations of n-3 PUFAs', 'spermatogram, seminal oxidative stress, and sperm phospholipids', 'mean\xa0±\xa0SD sperm progressive motility', 'sperm morphology and vitality']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0678896', 'cui_str': 'Endocrine function'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3715200', 'cui_str': 'Infertility clinic'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}]","[{'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C3661607', 'cui_str': 'Vitamin E supplement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0242499', 'cui_str': 'Seminal plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0037842', 'cui_str': 'Sperm count'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology'}]",717.0,0.607753,"Serum concentrations of n-3 PUFAs were significantly higher in the DE and DP groups than in the EP and PP groups.
","[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Eslamian', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Amirjannati', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Noori', 'Affiliation': ""Division of Nephrology, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Andrology and Embryology, Reproductive Biotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa124']
1176,32450939,Effectiveness of a culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention to reduce social anxiety and enhance self-esteem in adolescents: a randomized controlled trial from Pakistan.,"BACKGROUND


Social anxiety is common among adolescents in Pakistan and is associated with low self-esteem. Among the recommended treatments, cognitive behavioural therapy (CBT) is effective, and self-help approaches are encouraged.
AIM


To determine the effectiveness of culturally adapted CBT-based guided self-help (CACBT-GSH) intervention, using a manual 'Khushi aur Khatoon', for treating social anxiety when added to treatment as usual (TAU) compared with TAU only.
METHOD


A total of 76 adolescents with social anxiety aged 13-16 years from six schools in Multan, Pakistan were recruited into this randomized controlled trial. Participants were divided into intervention and control groups in a 1:1 ratio. Social anxiety, self-esteem and fear of negative evaluation were assessed through the Liebowtiz Social Anxiety Scale for children and adolescents, the Rosenberg Self-Esteem Scale and the Brief Fear of Negative Evaluation, respectively, at baseline and at the end of the study. Guided self-help using culturally adapted CBT (CACBT)-based self-help manual (eight sessions, one session per week) was provided to the intervention group. The effect of the CACBT-GSH intervention was analysed with ANCOVA.
RESULTS


There was a statistically significant difference between the intervention and the control groups in favour of intervention. Participants in the intervention group showed reduced symptoms of social anxiety (p < .001), fear of negative evaluation (p < .001) and enhanced self-esteem (p < .001).
CONCLUSION


The study demonstrated the effectiveness of CACBT-based guided self-help intervention in treating social anxiety and addressing the symptoms associated with it.",2020,"Participants in the intervention group showed reduced symptoms of social anxiety (p < .001), fear of negative evaluation (p < .001) and enhanced self-esteem (p < .001).
","['76 adolescents with social anxiety aged 13-16 years from six schools in Multan, Pakistan', 'adolescents']","['CACBT-GSH intervention', 'culturally adapted CBT-based guided self-help (CACBT-GSH) intervention', 'CACBT-based guided self-help intervention', 'culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention', 'cognitive behavioural therapy (CBT', 'Guided self-help using culturally adapted CBT (CACBT)-based self-help manual']","['social anxiety and enhance self-esteem', 'Social anxiety, self-esteem and fear of negative evaluation', 'Liebowtiz Social Anxiety Scale', 'reduced symptoms of social anxiety', 'fear of negative evaluation', 'enhanced self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",76.0,0.0186652,"Participants in the intervention group showed reduced symptoms of social anxiety (p < .001), fear of negative evaluation (p < .001) and enhanced self-esteem (p < .001).
","[{'ForeName': 'Rizwana', 'Initials': 'R', 'LastName': 'Amin', 'Affiliation': 'Department of Professional Psychology, Bahria University, Islamabad, Pakistan.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Applied Psychology, Bahauddin Zakariya UniversityMultan, Pakistan.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'University of Toronto and Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Irfan', 'Affiliation': 'Department of Mental Health, Psychiatry & Behavioural Sciences, Peshawar Medical College, Riphah International University, Islamabad, Pakistan.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000284']
1177,32459631,Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial.,"BACKGROUND


The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC's diabetes prevention program (DPP).
OBJECTIVE


This study aimed to investigate the long-term weight loss and glycemic efficacy of a mobile-delivered DPP compared with a control group receiving usual medical care.
METHODS


Adults with prediabetes (N=202) were recruited from a clinic and randomized to either a mobile-delivered, coach-guided DPP (Noom) or a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention. The intervention group learned how to use the Noom program, how to interact with their coach, and the importance of maintaining motivation. They had access to an interactive coach-to-participant interface and group messaging, daily challenges for behavior change, DPP-based education articles, food logging, and automated feedback. Primary outcomes included changes in weight and hemoglobin A 1c  (HbA 1c ) levels at 6 and 12 months, respectively. Exploratory secondary outcomes included program engagement as a predictor of changes in weight and HbA 1c  levels.
RESULTS


A total of 202 participants were recruited and randomized into the intervention (n=101) or control group (n=99). In the intention-to-treat (ITT) analyses, changes in the participants' weight and BMI were significantly different at 6 months between the intervention and control groups, but there was no difference in HbA 1c  levels (mean difference 0.004%, SE 0.05; P=.94). Weight and BMI were lower in the intervention group by -2.64 kg (SE 0.71; P<.001) and -0.99 kg/m2 (SE 0.29; P=.001), respectively. These differences persisted at 12 months. However, in the analyses that did not involve ITT, program completers achieved a significant weight loss of 5.6% (SE 0.81; P<.001) at 6 months, maintaining 4.7% (SE 0.88; P<.001) of their weight loss at 12 months. The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months. Those randomized to the intervention group who did not start the program had no meaningful weight or HbA 1c  level change, similar to the control group. At 1 year, the intervention group showed a 0.23% reduction in HbA 1c  levels; those who completed the intervention showed a 0.28% reduction. Those assigned to the control group had a 0.16% reduction in HbA 1c  levels.
CONCLUSIONS


This novel mobile-delivered DPP achieved significant weight loss reductions for up to 1 year compared with usual care. This type of intervention reduces the risk of overt diabetes without the added barriers of in-person interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03865342; https://clinicaltrials.gov/ct2/show/NCT03865342.",2020,The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months.,"['People with Pre-diabetes', '202 participants were recruited and randomized into the intervention (n=101) or control group (n=99', 'Adults with prediabetes (N=202']","['control group receiving usual medical care', 'mobile-delivered, coach-guided DPP or to a control group that received regular medical care including a paper-based DPP curriculum and no formal intervention', 'Mobile Delivery of the Diabetes Prevention Program', 'mobile-delivered DPP']","['risk of overt diabetes', 'HbA1c', 'program engagement as a predictor of changes in weight and HbA1c', 'weight loss', 'weight and BMI', 'weight loss reductions', 'glycemic efficacy', 'changes in weight and hemoglobin A1c (HbA1c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",202.0,0.118825,The control group lost -0.15% at 6 months (SE 0.64; P=.85) and gained 0.33% (SE 0.70; P=.63) at 12 months.,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Toro-Ramos', 'Affiliation': 'Noom, Inc, New York, NY, United States.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michaelides', 'Affiliation': 'Noom, Inc, New York, NY, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Anton', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Zulekha', 'Initials': 'Z', 'LastName': 'Karim', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Kang-Oh', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Charalambos', 'Initials': 'C', 'LastName': 'Argyrou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Loukaidou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Charitou', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Sze', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Endocrinology & Metabolism, Renaissance School of Medicine, Stony Brook University, Stony Brook, NY, United States.'}]",JMIR mHealth and uHealth,['10.2196/17842']
1178,32460752,The efficacy of a mobile phone application to improve adherence to treatment and self-management in people with chronic respiratory disease in Romanian population - a pilot study.,"BACKGROUND


Many studies assessed the effect of mobile phone applications on self-management outcomes in patients with asthma, but all of them presented variable results. In this paper. we examined the effect of a mobile phone application on self-management and disease control in Romanian population.
METHODS


This study included 93 patients diagnosed with asthma that were recalled every three months for a year for assessment and treatment. Patients were divided into two groups. The first group included patients that received treatment, and the second group received treatment and also used the smartphone application. Number of exacerbations and asthma control test (ACT) were recorded.
RESULTS


The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001). Also, we found significant differences between the ACT score with-in each group, observing a significant improvement of the score between evaluations and baseline (related-samples Friedman's test with Bonferroni correction, p <  0.001). When considering the exacerbations rate, significantly less patients using the application presented exacerbations, 10.30% vs. 46.30% (Pearson Chi-square test, X 2  (1) = 13.707, p <  0.001).
CONCLUSION


Our study indicates that smartphone applications are an effective way to improve asthma control and self-management when used continually in our population. We found significant positive effects in disease control and exacerbation frequency.",2020,"The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001).","['93 patients diagnosed with asthma that were recalled every three months for a year for assessment and treatment', 'patients with asthma', 'Romanian population', 'people with chronic respiratory disease in Romanian population ']","['mobile phone applications', 'smartphone application', 'mobile phone application']","['Number of exacerbations and asthma control test (ACT', 'exacerbations rate', 'ACT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",93.0,0.0376453,"The ACT score was significantly higher for asthma patients using also the mobile application than for the patients using the treatment alone, for all the evaluation moments (Mann-Whitney U test, p <  0.001).","[{'ForeName': 'Laura Adela', 'Initials': 'LA', 'LastName': 'Munteanu', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Frandes', 'Affiliation': 'Department of Biostatistics and Medical Informatics, ""Victor Babeș"" University of Medicine and Pharmacy, Eftimie Murgu, 30041, Timișoara, Romania. mirela.frandes@umft.ro.'}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Timar', 'Affiliation': 'Department of Biostatistics and Medical Informatics, ""Victor Babeș"" University of Medicine and Pharmacy, Eftimie Murgu, 30041, Timișoara, Romania.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Tudorache', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Ariadna Petronela', 'Initials': 'AP', 'LastName': 'Fildan', 'Affiliation': 'Internal Medicine Discipline, Medical Clinical Disciplines I, ""Ovidius"" University of Constanta, Faculty of Medicine, Constanta, Romania.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Oancea', 'Affiliation': 'Department of Pulmonology, ""Victor Babeș"" University of Medicine and Pharmacy, Timișoara, Romania.'}, {'ForeName': 'Doina Ecaterina', 'Initials': 'DE', 'LastName': 'Tofolean', 'Affiliation': 'Internal Medicine Discipline, Medical Clinical Disciplines I, ""Ovidius"" University of Constanta, Faculty of Medicine, Constanta, Romania.'}]",BMC health services research,['10.1186/s12913-020-05340-0']
1179,32460773,Protocol for the economic evaluation of the InTENSE program for rehabilitation of chronic upper limb spasticity.,"BACKGROUND


Assessment of the costs of care associated with chronic upper-limb spasticity following stroke in Australia and the potential benefits of adding intensive upper limb rehabilitation to botulinum toxin-A are key objectives of the InTENSE randomised controlled trial.
METHODS


Recruitment for the trial has been completed. A total of 139 participants from 6 stroke units across 3 Australian states are participating in the trial. A cost utility analysis will be undertaken to compare resource use and costs over 12 months with health-related quality of life outcomes associated with the intervention relative to a usual care comparator. A cost effectiveness analysis with the main clinical measure of outcome, Goal Attainment Scaling, will also be undertaken. The primary outcome measure for the cost utility analysis will be the incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained. The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year (QALY) gains for the intervention relative to usual care using area-under the curve methods.
DISCUSSION


The results of the economic evaluation will provide evidence of the total costs of care for patients with chronic upper limb spasticity following stroke. It will also provide evidence for the cost-effectiveness of adding evidence-based movement therapy to botulinum toxin-A as a treatment, providing important information for health system decision makers tasked with the planning and provision of services.",2020,"The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year","['patients with chronic upper limb spasticity following stroke', '139 participants from 6 stroke units across 3 Australian states are participating in the trial']",[],"['cost utility analysis', 'incremental cost effectiveness ratio (ICER) generated from the incremental cost of the intervention as compared to the incremental benefit, as measured in quality adjusted life years (QALYs) gained', 'incremental Quality Adjusted Life Year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",139.0,0.148825,"The utility scores generated from the EQ-5D three level instrument (EQ-5D-3 L) measured at baseline, 3 months and 12 months will be utilised to calculate the incremental Quality Adjusted Life Year","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Milte', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, South Australia, 5001, Australia. rachel.milte@flinders.edu.au.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'Caring Futures Institute, Flinders University, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ada', 'Affiliation': 'Discipline of Physiotherapy, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': 'School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'Department of Neurosciences, Central Clinical School, Monash University, Melbourne, Australia.'}]",BMC health services research,['10.1186/s12913-020-05333-z']
1180,32466710,Effects of acute alcohol consumption on emotion recognition in high and low trait aggressive drinkers.,"BACKGROUND


Research suggests that acute alcohol consumption impairs processing of emotional faces. As emotion processing plays a key role in effective social interaction, these impairments may be one mechanism by which alcohol changes social behaviour. This study investigated the effect of individual differences on this relationship by comparing emotion recognition performance after acute alcohol consumption in individuals with high and low trait aggression.
METHODS


Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive). Participants attended two sessions. In one they consumed an alcoholic drink (0.4 g/kg) and in the other they consumed a matched placebo. They then completed two computer-based tasks: one measured global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad).
RESULTS


There was evidence of poorer global emotion recognition after alcohol. In addition, there was evidence of poorer sensitivity to sadness and fear after alcohol. There was also evidence for a reduced bias towards happiness following alcohol and weak evidence for an increased bias towards sadness.
CONCLUSIONS


These findings suggest that alcohol impairs global emotion recognition. They also highlight a reduced ability to detect sadness and fearful facial expressions. As sadness and fear are cues of submission and distress (i.e. function to curtail aggression), failure to successfully detect these emotions when intoxicated may increase the likelihood of aggressive responding. This coupled with a reduced bias towards seeing happiness may collectively contribute to aggressive behaviour.",2020,There was evidence of poorer global emotion recognition after alcohol.,"['individuals with high and low trait aggression', 'Regular non-dependent drinkers, either high or low in trait aggression participated in a double-blind placebo-controlled experiment ( N  = 88, 50% high trait aggressive', 'high and low trait aggressive drinkers']","['acute alcohol consumption', 'alcoholic drink', 'placebo']","['poorer global emotion recognition', 'global and emotion-specific recognition performance across six primary emotions (anger, sadness, happiness, disgust, fear, surprise), the other measured processing bias of two ambiguously expressive faces (happy-angry/happy-sad', 'global emotion recognition', 'emotion recognition', 'emotion recognition performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",,0.189109,There was evidence of poorer global emotion recognition after alcohol.,"[{'ForeName': 'Andrew Pr', 'Initials': 'AP', 'LastName': 'Eastwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Penton-Voak', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}, {'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Attwood', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120922951']
1181,32472928,Effect of an Innovative Mattress and Cryotherapy on Sleep after an Elite Rugby Match.,"INTRODUCTION


This study aimed to explore the relationship between elite rugby union match and postmatch sleep architecture and to investigate the effects of a high-heat capacity mattress (MAT) and a whole-body cryotherapy (WBC) session on postmatch sleep architecture.
METHODS


Nineteen elite male U23 rugby union players performed in three official matches, followed by three experimental conditions, in a randomized order: MAT, WBC, and no intervention (CONT). Match load was evaluated using GPS trackers and video analyses. Sleep architecture was assessed by polysomnography (PSG). Core body temperature (CBT) and mattress surface temperature were monitored during sleep. Linear mixed-effects models were conducted to assess the effects of each experimental condition on sleep, with match load variables as covariates.
RESULTS


A lower wake after sleep onset (β = -10.5 min, P < 0.01) and higher rapid eye movement sleep proportion (β = +2.8%, P < 0.05) were reported for MAT compared with CONT. Moreover, lower mean CBT (β = -0.135°C, P < 0.001) and mean mattress surface temperature (β = -2.736°C, P < 0.001) during sleep were observed for MAT compared CONT. WBC did not affect nocturnal CBT nor interfere with sleep architecture. For every 100-m increase in high-speed running distance, a higher slow wave sleep (β = +1.1%, P = 0.05) and lower light sleep proportion (β = -1.2%, P < 0.05) proportion were observed. Conversely, for every 10 supplementary collisions, lower slow wave sleep (β = -1.9, P = 0.09) and higher light sleep (β = +2.9%, P < 0.001) proportion were observed.
CONCLUSION


MAT use had a positive effect on sleep architecture after an elite rugby union match, potentially through a more efficient nocturnal heat transfer.",2020,"A lower wake after sleep onset (β = -10.5 min, p < 0.01) and higher rapid-eye-movement sleep proportion (β = +2.8%, p < 0.05) were reported for MAT compared with CONT.","['Nineteen elite male U23 rugby union players', 'Sleep after an Elite Rugby Match']","['Innovative Mattress and Cryotherapy', 'high-heat capacity mattress (MAT) and a whole-body cryotherapy session (WBC', 'MAT, WBC, and no intervention (CONT']","['sleep architecture', 'mean mattress surface temperature', 'Core body temperature (CBT) and mattress surface temperature', 'Sleep architecture', 'nocturnal CBT nor interfere with sleep architecture', 'higher light sleep', 'high-speed running distance', 'lower light sleep proportion', 'higher rapid-eye-movement sleep proportion']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0245845', 'cui_str': 'U23'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0456240', 'cui_str': 'Core body temperature'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0278182', 'cui_str': 'Light sleep'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}]",19.0,0.0169283,"A lower wake after sleep onset (β = -10.5 min, p < 0.01) and higher rapid-eye-movement sleep proportion (β = +2.8%, p < 0.05) were reported for MAT compared with CONT.","[{'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Aloulou', 'Affiliation': 'Laboratory of Sport, Expertise and Performance (EA 7370), French National Institute of Sport (INSEP), Paris, FRANCE.'}, {'ForeName': 'CÉdric', 'Initials': 'C', 'LastName': 'Leduc', 'Affiliation': 'Carnegie Applied Rugby Research (CARR) Center, Institute for Sport, Physical Activity and Leisure, Carnegie School of Sport, Leeds Beckett University, Leeds, UNITED KINGDOM.'}, {'ForeName': 'FranÇois', 'Initials': 'F', 'LastName': 'Duforez', 'Affiliation': 'Sleep and Vigilance Center, Hospital Hotel-Dieu, Paris, FRANCE.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Piscione', 'Affiliation': 'Research Department, French Rugby Federation (FFR), Marcoussis, FRANCE.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cheradame', 'Affiliation': 'Research Department, French Rugby Federation (FFR), Marcoussis, FRANCE.'}, {'ForeName': 'FranÇois', 'Initials': 'F', 'LastName': 'Bieuzen', 'Affiliation': 'Institut National du Sport (INS) du Québec, Montréal, CANADA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Thomas', 'Affiliation': 'Laboratory of Sport, Expertise and Performance (EA 7370), French National Institute of Sport (INSEP), Paris, FRANCE.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Chennaoui', 'Affiliation': 'Vigilance Fatigue Sommeil Unit (VIFASOM) EA 7330, University Paris Descartes, Paris, FRANCE.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'VAN Beers', 'Affiliation': 'Vigilance Fatigue Sommeil Unit (VIFASOM) EA 7330, University Paris Descartes, Paris, FRANCE.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Nedelec', 'Affiliation': 'Laboratory of Sport, Expertise and Performance (EA 7370), French National Institute of Sport (INSEP), Paris, FRANCE.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002403']
1182,32471729,Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study.,"PURPOSE


To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
DESIGN


Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis.
PARTICIPANTS


Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled.
METHODS


Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4).
MAIN OUTCOME MEASURES


The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs).
RESULTS


The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids.
CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.",2020,"CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","['Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled', 'Neovascular Age-Related Macular Degeneration', '1888', 'Patients (n\xa0', 'naïve patients with neovascular age-related macular degeneration (AMD']","['topical corticosteroids', 'oral and/or injectable corticosteroids', 'Abicipar', 'ranibizumab 0.5 mg every 4 weeks (Q4', 'ranibizumab']","['Intraocular inflammation', 'change from baseline in BCVA and central retinal thickness (CRT', 'Efficacy and Safety', 'Incidence of intraocular inflammation (IOI) AEs', 'proportion of patients with stable vision', 'efficacy and safety', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",1888.0,0.237033,"CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kunimoto', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: derek_kunimoto@yahoo.com.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Sydney Retina Clinic, Sydney, Australia; Save Sight Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Hansjürgen', 'Initials': 'H', 'LastName': 'Agostini', 'Affiliation': 'Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Souied', 'Affiliation': ""Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Chow', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada; Toronto Retina Institute, North York, Ontario, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lotery', 'Affiliation': 'University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Vision Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Le', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmidt', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Yehia', 'Initials': 'Y', 'LastName': 'Hashad', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.035']
1183,32471730,Usefulness of a circumferential wound retractor in emergency colorectal surgery as a preventive measure for surgical site infection. Alexis O-Ring® and emergency surgery.,"INTRODUCTION AND AIMS


More than 20% of healthcare-associated infections correspond to those at surgical sites, and there is a higher incidence of infections in colorectal surgery due to the associated bacterial load. Surgical wound protectors are designed to prevent contamination and mechanical trauma. Our aim was to demonstrate the usefulness of a circumferential wound retractor/protector for the prevention of surgical site infections (SSIs) in emergency colorectal surgery.
METHODS


Forty-one patients that underwent emergency open surgery at a tertiary care hospital were randomized into 2 groups: 20 cases without the retractor (group A) and 21 cases with the retractor (group B). Subjects were assigned to a group in a 1:1 randomization allocation ratio. The chi-square and Fisher's exact tests were employed for the quantitative variables, and the statistical analysis was performed using the IBM Statistical Package for the Social Sciences software for Mac, version 16.0 (IBM SPSS Inc., Chicago, IL, USA).
RESULTS


The SSI rate was 17%. Six group A patients developed SSI versus one group B patient. The use of a circumferential wound retractor/protector was statistically significant for the prevention of surgical wound infections, with a P=.031 and an OR of 8.5. In addition, preoperative blood glucose levels below 200mg/dl provided a 3.2-times higher protective effect, compared with glucose levels above 200mg/dl.
CONCLUSIONS


In the present prospective randomized pilot study, the use of the circumferential wound retractor/protector significantly decreased the likelihood of SSI in emergency colorectal surgery.",2020,"The use of a circumferential wound retractor/protector was statistically significant for the prevention of surgical wound infections, with a P=.031 and an OR of 8.5.","['Forty-one patients that underwent emergency open surgery at a tertiary care hospital were randomized into 2 groups: 20 cases without the retractor (group A) and 21 cases with the retractor (group B', 'emergency colorectal surgery']","['circumferential wound retractor', 'Surgical wound protectors', 'circumferential wound retractor/protector', 'Alexis O-Ring® and emergency surgery']","['SSI rate', 'surgical wound infections', 'preoperative blood glucose levels', 'likelihood of SSI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0445425', 'cui_str': 'Alexi'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",41.0,0.0384904,"The use of a circumferential wound retractor/protector was statistically significant for the prevention of surgical wound infections, with a P=.031 and an OR of 8.5.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Salgado-Nesme', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México. Electronic address: noelsalgadonesme@yahoo.com.mx.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Morales-Cruz', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Navarro-Navarro', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Patiño-Gómez', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Vergara-Fernández', 'Affiliation': 'Departamento de Cirugía Colorrectal, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Ciudad de México, México.'}]",Revista de gastroenterologia de Mexico,['10.1016/j.rgmx.2019.08.009']
1184,32476057,The impact of employment on recovery among individuals who are homeless with severe mental illness in the Vancouver At Home/Chez Soi trial.,"OBJECTIVE


To assess impact of employment on recovery in a sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders.
METHODS


The VAH included two randomized controlled trials investigating the effect of housing first with support intervention in vulnerable population. Employment was assessed at baseline and during the follow-up using Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires, respectively. Recovery was examined using Recovery Assessment Scale (RAS) at baseline and at 24-month follow-up visit. Multivariable regression models were built to examine: (1) the effect of current employment at baseline on RAS score at baseline, and RAS score at 24-month follow-up visit; and (2) and to examine the cumulative effect of recent employment over 8 follow-up visits on RAS score at 24-month visit. Cumulative effect of employment over the follow-up visits was weighted by recency using a pre-specified weighting function.
RESULTS


Employment at baseline was associated with an increase in recovery score at baseline [8.06 (95% CI 1.21, 14.91); p = 0.02], but not with recovery score at 24-month follow-up visit [3.78 (-4.67, 12.24); p = 0.37]. Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
CONCLUSION


Employment is associated with an increase in recovery. Our result suggests a dual effect of employment on recovery, an immediate effect through current employment, and a long-term effect of cumulative employment.",2020,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","['sample of adults from Vancouver At Home (VAH) study, who were homeless and were diagnosed with severe mental disorders', 'individuals who are homeless with severe mental illness in the Vancouver', 'vulnerable population']",['housing first with support intervention'],"['recovery score', 'recovery', 'RAS score at baseline, and RAS score', 'Demographics, Housing, Vocational, and Service Use History (DSHH), and Vocational Timeline Follow-Back (VTLFB) self-report questionnaires', 'Recovery Assessment Scale (RAS', 'RAS score']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.178522,"Weighted cumulative effect of employment over 8 follow-up visits was associated with increase in RAS score at 24-month follow-up visit [8.33 (1.68, 14.99) p = 0.01].
","[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Yazdani', 'Affiliation': 'Addiction and Concurrent Disorders Group, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada. kia_yzd@yahoo.com.'}, {'ForeName': 'Mohammadali', 'Initials': 'M', 'LastName': 'Nikoo', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Sayre', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Choi', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Reinhard Michael', 'Initials': 'RM', 'LastName': 'Krausz', 'Affiliation': 'Addiction and Concurrent Disorders Group, Centre for Health Evaluation Outcome Sciences, Department of Psychiatry, Faculty of Medicine, Institute of Mental Health, University of British Columbia, Vancouver, Canada.'}]",Social psychiatry and psychiatric epidemiology,['10.1007/s00127-020-01887-9']
1185,32463163,Peritoneal bridging versus fascial closure in laparoscopic intraperitoneal onlay ventral hernia mesh repair: a randomized clinical trial.,"BACKGROUND


Many patients develop seroma after laparoscopic ventral hernia repair. It was hypothesized that leaving the hernial sac in situ may cause this complication.
METHODS


In this patient- and outcome assessor-blinded, parallel-design single-centre trial, patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair were randomized (1 : 1) to either conventional fascial closure or peritoneal bridging. The primary endpoint was the incidence of seroma 12 months after index surgery detected by CT, evaluated in an intention-to-treat analysis.
RESULTS


Between September 2017 and May 2018, 62 patients were assessed for eligibility, of whom 25 were randomized to conventional closure and 25 to peritoneal bridging. At 3 months, one patient was lost to follow-up in the conventional and peritoneal bridging groups respectively. No seroma was detected at 6 or 12 months in either group. The prevalence of clinical seroma was four of 25 (16 (95 per cent c.i. 2 to 30) per cent) versus none of 25 patients in the conventional fascial closure and peritoneal bridging groups respectively at 1 month after surgery (P = 0·110), and two of 24 (8 (0 to 19) per cent) versus none of 25 at 3 months (P = 0·235). There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.
CONCLUSION


Conventional fascial closure and peritoneal bridging did not differ with regard to seroma formation after laparoscopic ventral hernia repair.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03344575).",2020,"There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.
","['patients develop seroma after laparoscopic ventral hernia repair', 'patients undergoing laparoscopic intraperitoneal onlay mesh ventral hernia repair', '62 patients were assessed for eligibility, of whom 25 were randomized to', 'Between September 2017 and May 2018']","['conventional closure and 25 to peritoneal bridging', 'laparoscopic intraperitoneal onlay ventral hernia mesh repair', 'Peritoneal bridging versus fascial closure', 'Conventional fascial closure and peritoneal bridging', 'conventional fascial closure or peritoneal bridging']","['rate of recurrent hernia', 'postoperative pain', 'prevalence of clinical seroma', 'seroma formation', 'postoperative complications', 'No seroma', 'incidence of seroma 12\u2009months after index surgery detected by CT, evaluated in an intention-to-treat analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",62.0,0.371909,"There were no significant differences between the groups in other postoperative complications (one of 25 versus 0 of 25), rate of recurrent hernia within 1 year (none in either group) or postoperative pain.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ali', 'Affiliation': 'Departments of Surgery, Örebro University Hospital, School of Medical Sciences, Örebro University, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wallin', 'Affiliation': 'Departments of Surgery, Örebro University Hospital, School of Medical Sciences, Örebro University, Stockholm, Sweden.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fathalla', 'Affiliation': 'Emergency Department, Södersjukhuset, Stockholm, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sandblom', 'Affiliation': 'Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}]",BJS open,['10.1002/bjs5.50305']
1186,32461441,Comparative study of pars plana vitrectomy with or without intravitreal dexamethasone implant for idiopathic epiretinal membrane.,"Purpose


To investigate if use of adjunctive intravitreal dexamethasone implant during pars plana vitrectomy (PPV) leads to faster visual recovery and reduction of retinal thickness in idiopathic epiretinal membrane (ERM).
Methods


In this non-randomized, comparative, interventional study 30 eyes (from 30 patients with idiopathic ERM) were enrolled. In the control group (n = 15), patients underwent 25-G pars plana vitrectomy (PPV) and ERM peeling. In the study group (n = 15), each patient underwent the same procedure as those in the control group, and also received an additional dexamethasone implant. Primary outcome after treatment was mean gain in best corrected visual acuity (BCVA), and secondary outcome was reduction in central retinal thickness (CRT). Data were analyzed using Fisher's exact test, Wilcoxon rank sum test, and two-sample t-test.
Results


The mean gain in BCVA (logMAR) from baseline at 1-month follow-up was significantly higher in the study group (median = -0.3, IQR = -0.4, -0.1) than in the control group (median = 0, IQR = -0.1, 0.3; P < 0.008). However, no significant difference in mean gain in BCVA between the two groups was detectable at the 6-month follow-up (P < 0.55). At 1-month follow-up, one and seven patients in the control and study groups gained ≥15 letters of BCVA (P < 0.05), respectively. The mean reductions in CRT at the 1-month follow-up were significantly higher in the study group than in the control group (Mean = -60 μm, SD = 92.1; P < 0.014; 95% CI = 19.75-156.54). The difference in mean reduction of CRT at 6 months was not significant (P < 0.24).
Conclusion


Adjunctive dexamethasone implant can aid faster visual recovery after PPV in idiopathic ERM, although the implants do not affect long-term gains in visual acuity.",2020,"However, no significant difference in mean gain in BCVA between the two groups was detectable at the 6-month follow-up (P < 0.55).","['idiopathic epiretinal membrane (ERM', '30 eyes (from 30 patients with idiopathic ERM', 'idiopathic epiretinal membrane']","['dexamethasone implant', 'adjunctive intravitreal dexamethasone implant during pars plana vitrectomy (PPV', 'pars plana vitrectomy with or without intravitreal dexamethasone implant', '25-G pars plana vitrectomy (PPV) and ERM peeling']","['mean reduction of CRT', 'mean gain in BCVA (logMAR', 'mean reductions in CRT', 'mean gain in best corrected visual acuity (BCVA), and secondary outcome was reduction in central retinal thickness (CRT', 'mean gain in BCVA', 'visual recovery']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",30.0,0.0449722,"However, no significant difference in mean gain in BCVA between the two groups was detectable at the 6-month follow-up (P < 0.55).","[{'ForeName': 'Surabhi S', 'Initials': 'SS', 'LastName': 'Sane', 'Affiliation': 'Kanuri Santhamma Vitreo-Retina Service, L. V. Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Mohammad Hasnat', 'Initials': 'MH', 'LastName': 'Ali', 'Affiliation': 'Department of Biostatistics; Suven Clinical Research Center, Hyderabad Eye Research Foundation, L.V. Prasad Eye Institute, Hyderabad, Telangana, India.'}, {'ForeName': 'Baruch D', 'Initials': 'BD', 'LastName': 'Kuppermann', 'Affiliation': 'Gavin Herbert Eye Institute, University of California, Irvine, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Narayanan', 'Affiliation': 'Kanuri Santhamma Vitreo-Retina Service; Suven Clinical Research Center, Hyderabad Eye Research Foundation, L.V. Prasad Eye Institute, Hyderabad, Telangana, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1045_19']
1187,32461540,Recovery From Exhaustion of the Frank-Starling Mechanism by Mechanical Unloading With a Continuous-Flow Ventricular Assist Device.,"BACKGROUND


We describe our original left ventricular assist device (LVAD) speed ramp and volume loading test designed to evaluate native heart function under continuous-flow LVAD support.Methods and Results:LVAD speed was decreased in 4 stages from the patient's optimal speed to the minimum setting for each device. Under minimal LVAD support, patients were subjected to saline loading (body weight [kg]×10 mL in 15 min). Echocardiographic and hemodynamic data were obtained at each stage of the LVAD speed ramp and every 3 min during saline loading. Patients were divided into Recovery (with successful LVAD removal; n=8) and Non-recovery (others; n=31) groups. During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173). Increased cardiac output from volume loading was significantly higher in the Recovery than Non-recovery group (group effect, P=0.0124; time effect, P<0.0001; interaction effect, P=0.0091). Therefore, the Frank-Starling curve of the Recovery group was located upward and to the left of that of the Non-recovery group.
CONCLUSIONS


The LVAD speed ramp and volume loading test facilitates the precise evaluation of native heart function during continuous-flow LVAD support.",2020,"During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173).",[],['saline loading (body weight'],"['Frank-Starling curve', 'Increased cardiac output from volume loading', 'pulmonary capillary wedge pressure', 'Echocardiographic and hemodynamic data']",[],"[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0326711', 'cui_str': 'Sturnus vulgaris'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0416434,"During testing, increased pulmonary capillary wedge pressure caused by volume loading was milder in the Recovery than Non-recovery group (repeated measures analysis of variance; group effect, P=0.0069; time effect, P<0.0001; interaction effect, P=0.0173).","[{'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Surgery, Fukui Cardiovascular Center.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Miyagawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Fusako', 'Initials': 'F', 'LastName': 'Sera', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Nakamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Daimon', 'Affiliation': 'Department of Biostatistics, Hyogo College of Medicine.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sawa', 'Affiliation': 'Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0070']
1188,32456236,"A Lifestyle (Dietary) Intervention Reduces Tiredness in Children with Subclinical Hypothyroidism, a Randomized Controlled Trial.","PURPOSE


Subclinical hypothyroidism (SH) in children and adults is a subject for discussion in terms of whether to treat it or not with respect to the short-term clinical implications and consequences of SH and in the long term. If treatment with thyroxine supplementation is not indicated, no other treatment is available. We investigated whether a lifestyle (dietary) intervention improves or normalizes SH or decreases the presence of Thyroid Stimulating Hormone (TSH) and/or tiredness.  Methods : We randomized children aged 1-12 years with SH to the control group (standard care = no treatment) or intervention group (dietary intervention). The dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months. The rest of the diet remained unchanged. We measured TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores.  Results : In total, 62 children were included. After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98). PedQL fatigue scores for sleep ( p  = 0.032) and total fatigue scores ( p  = 0.039) improved significantly in the intervention group, compared to the control group. No unfavorable effects occurred in the lipid profile or BMI.  Conclusion : The lifestyle (dietary) intervention did not normalize SH and TSH levels, but it significantly reduced tiredness. These results suggest that children's well-being can be improved without medication.",2020,"After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98).","['children and adults', '62 children were included', 'children aged 1-12 years with SH to the control group (standard care = no treatment) or', 'Children with Subclinical Hypothyroidism']","['dietary intervention consisted of green vegetables, beef, whole milk and butter for 6 months', 'A Lifestyle (Dietary) Intervention', 'thyroxine supplementation', 'intervention group (dietary intervention', 'lifestyle (dietary) intervention']","['Tiredness', 'Thyroid Stimulating Hormone (TSH) and/or tiredness', 'TSH', 'PedQL fatigue scores for sleep', 'normalize SH and TSH levels', 'lipid profile or BMI', 'total fatigue scores', 'tiredness', 'TSH, FreeT4, Lipid profile, Body Mass Index (BMI) and Pediatric Quality of Life (PedQL) multidimensional fatigue scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",62.0,0.037638,"After 6 months, TSH decreased in both groups without a significant difference between the groups ( p  = 0.98).","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Gaag', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Faculty of Behavioural, Management and Social Sciences (BMS), University of Twente, 7522 NB Enschede, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Schaap', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Mirthe', 'Initials': 'M', 'LastName': 'van Voorthuizen', 'Affiliation': 'Department of Pediatrics, Hospital Group Twente, 7609 PP Almelo, The Netherlands.'}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Department of Pediatrics, Medical Centre Twente, 7512 KZ Enschede, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17103689']
1189,32456250,Effects of the Use of Air Purifier on Indoor Environment and Respiratory System among Healthy Adults.,"Air purifiers have become popular among ordinary families. However, it remains controversial whether indoor air purification improves the respiratory health of healthy adults. A randomized crossover intervention study was conducted with 32 healthy individuals. The subjects were categorized into two groups. One group continuously used true air purifiers, and the other followed with sham air purifiers for 4 weeks. Following this first intervention, all the subjects underwent a 4-week washout period and continued with the second 4-week intervention with the alternate air purifiers. We collected fine particulate matter (PM) ≤ 2.5 µm in aerodynamic diameter (PM2.5), coarse particulate matter between 2.5 and 10 µm in aerodynamic diameter (PM10-2.5) and ozone (O 3 ). The subjects' pulmonary function and fractional exhaled nitric oxide (FeNO) were measured during the study period. The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers. However, this decrease was not significant ( p  = 0.08). The air purification did not significantly improve the pulmonary function of the study subjects. In contrast, an increase in the indoor PM10-2.5 and O 3  concentration led to a significant decrease in the forced expiratory volume in one second (FEV 1.0 )/forced vital capacity (FVC) and maximal mid-expiratory flow (MMEF), respectively. In conclusion, air purification slightly improved the indoor PM2.5 concentrations in ordinary homes but had no demonstrable impact on improving health.",2020,The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers.,"['Healthy Adults', 'healthy adults', '32 healthy individuals']",['Air Purifier'],"['health', 'indoor PM2.5 concentrations', 'pulmonary function', 'Indoor Environment and Respiratory System', ""subjects' pulmonary function and fractional exhaled nitric oxide (FeNO"", 'forced expiratory volume in one second (FEV 1.0 )/forced vital capacity (FVC) and maximal mid-expiratory flow (MMEF']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0262774', 'cui_str': 'Air Purifier'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231985', 'cui_str': 'Mean maximum expiratory flow'}]",32.0,0.016093,The indoor PM2.5 concentrations decreased by 11% with the true air purifiers compared to those with sham air purifiers.,"[{'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Yoda', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba 305-8506, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': ""Hyogo Regional Center of Japan Environment and Children's Study, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.""}, {'ForeName': 'Naruhito', 'Initials': 'N', 'LastName': 'Otani', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}, {'ForeName': 'Shoji F', 'Initials': 'SF', 'LastName': 'Nakayama', 'Affiliation': 'Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba 305-8506, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Shima', 'Affiliation': 'Department of Public Health, Hyogo College of Medicine, Nishinomiya 663-8501, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17103687']
1190,32459651,A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial.,"BACKGROUND


Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited.
OBJECTIVE


This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes.
METHODS


We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c  (HbA 1c ) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c  level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels.
RESULTS


We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for physical activity levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months.
CONCLUSIONS


This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397.",2020,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"['people with pre-diabetes', 'People at High Risk of Type 2 Diabetes', 'We enrolled 200 participants: 98', 'people at high risk of developing diabetes', 'Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London']","['smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months', 'Wearable Technology Delivering a Web-Based Diabetes Prevention Program', 'web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP']","['weight', 'PA levels', 'change in HbA1c, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels', 'full-scale RCT, namely, change in weight and physical activity (PA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4076391', 'cui_str': 'Motivational interviewing technique'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",200.0,0.204808,We did not observe a treatment effect on the secondary outcomes measured at 6-month or 12-month follow-up.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Staite', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al-Ozairi', 'Affiliation': 'Faculty of Medicine, Department of Medicine & Dasman Diabetes Institute, Kuwait University, Al Kuwayt, Kuwait.'}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hopkins', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's Health Partners, London, United Kingdom.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""South Thames Cleft Service, St Thomas' Hospital, London, United Kingdom.""}, {'ForeName': 'Neel', 'Initials': 'N', 'LastName': 'Basudev', 'Affiliation': 'Health Innovation Network, London, United Kingdom.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mohamedali', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}]",JMIR mHealth and uHealth,['10.2196/15448']
1191,32461420,A prospective study to assess the role of vitamin D individually and in combination with cyclosporine in the treatment of dry eye in patients with deficient serum 25(OH)D levels.,"Purpose


To study the efficiency of vitamin D3 (buccal spray) alone and combination of vitamin D3 with cyclosporine in the treatment of dry eye disease (DED) in patients with deficient serum 25(OH)D levels.
Methods


Around 90 patients with DED with deficient serum 25(OH)D levels were included and randomized into three groups and were given treatment for dry eye (Group A- 0.5% carboxymethylcellulose (CMC), Group B- 0.5% CMC + 2000 IU vitamin D through buccal spray, Group C- 0.5% CMC + 2000 IU vitamin D through buccal spray + 0.05% cyclosporine). The patients were followed at day-15, day-30, and day-90 for improvement in tear breakup time (TBUT) and Schirmer's, and ocular surface disease index (OSDI) score. Improvement in serum vitamin D level was assessed at day-90. One way ANOVA test, paired t-test, and Chi-square test were used for analysis.
Results


Group B and Group C had significantly higher in Schirmer's test-I values as compared to Group A (P = 0.001, P < 0.001, P < 0.001 at day-15, day-30, and day-90, respectively). Significantly higher values of TBUT and mean serum vitamin D levels were obtained in Group B and Group C as compared to Group A at day-90 (P < 0.05). OSDI scores of patients significantly decreased in all three groups at all follow-up visits (P < 0.05). Overall, Group C and Group B were found statistically better than Group A. Group C showed better results than Group B but they were nonsignificant.
Conclusion


Vitamin D supplementation leads to earlier and significant improvement in TBUT, Schirmer's, and OSDI score in patients with vitamin D deficient DED.",2020,"Overall, Group C and Group B were found statistically better than Group A. Group C showed better results than Group B but they were nonsignificant.
","['90 patients with DED with deficient serum 25(OH)D levels', 'patients with deficient serum 25(OH)D levels', 'patients with vitamin D deficient DED']","['Vitamin D supplementation', 'vitamin D3 (buccal spray) alone and combination of vitamin D3 with cyclosporine', 'vitamin D', 'cyclosporine', 'dry eye (Group A- 0.5% carboxymethylcellulose (CMC), Group B- 0.5% CMC + 2000 IU vitamin D through buccal spray, Group C- 0.5% CMC + 2000 IU vitamin D through buccal spray + 0.05% cyclosporine']","['TBUT and mean serum vitamin D levels', ""TBUT, Schirmer's, and OSDI score"", ""Schirmer's test"", 'OSDI scores', 'serum vitamin D level', ""tear breakup time (TBUT) and Schirmer's, and ocular surface disease index (OSDI) score""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4706608', 'cui_str': 'Conventional release buccal spray'}, {'cui': 'C3653679', 'cui_str': 'Combinations of vitamins'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0180163,"Overall, Group C and Group B were found statistically better than Group A. Group C showed better results than Group B but they were nonsignificant.
","[{'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Watts', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Sahai', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'P Ratan', 'Initials': 'PR', 'LastName': 'Kumar', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Mohd Abid', 'Initials': 'MA', 'LastName': 'Shamshad', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Gopal Krishan', 'Initials': 'GK', 'LastName': 'Trivedi', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}, {'ForeName': 'Lokendra', 'Initials': 'L', 'LastName': 'Tyagi', 'Affiliation': 'Department of Ophthalmology, Sahai Hospital And Research Centre, Jaipur, Rajasthan, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1492_19']
1192,32472172,Intravitreal ranibizumab alone or in combination with panretinal photocoagulation for the treatment of proliferative diabetic retinopathy with coexistent macular edema: long-term outcomes of a prospective study.,"AIMS


To compare intravitreal ranibizumab as monotherapy or in combination with panretinal photocoagulation (PRP) in patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME) in a long-term follow-up of 24 months.
METHODS


Participants in this prospective study were 47 patients with PDR and concurrent DME, who were randomized at baseline into two groups: (i) the ""ranibizumab alone"" group (n = 23), which was treated with at least 3 intravitreal ranibizumab injections as a loading phase, and (ii) the ""combination"" group (n = 24), which was treated with PRP and at least 3 intravitreal ranibizumab injections. Thereafter, all patients were followed up at a pro re nata (PRN) basis, with regular monthly monitoring for 24 months. At each visit, best corrected visual acuity (BCVA) and spectral domain-optical coherence tomography were performed, while regression of neovascularization was also recorded.
RESULTS


The ""combination"" group had better control of neovascularization and less events of vitreous hemorrhage than ranibizumab alone through the 2 years. BCVA did not differ significantly between the two groups at months 12 and 24 of the follow-up. The ""ranibizumab"" alone group presented greater reduction in central retinal thickness at month 12, which did not reach significance at month 24 compared to ""combination"" group. Greater number of injections was needed in the monotherapy group (mean 14 injections) compared to ""combination"" group (mean 11 injections) through month 24.
CONCLUSIONS


Both intravitreal ranibizumab alone or in combination with PRP could be used effectively for the treatment of PDR and coexistent DME. Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.",2020,"Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.","['patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME', 'proliferative diabetic retinopathy with coexistent macular edema', 'Participants in this prospective study were 47 patients with PDR and concurrent DME']","['ranibizumab alone"" group', 'ranibizumab injections', 'panretinal photocoagulation (PRP', 'intravitreal ranibizumab', 'Intravitreal ranibizumab alone or in combination with panretinal photocoagulation', 'ranibizumab']","['BCVA and CRT', 'Greater number of injections', 'vitreous hemorrhage', 'central retinal thickness', 'control of neovascularization', 'BCVA', 'corrected visual acuity (BCVA) and spectral domain-optical coherence tomography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",47.0,0.0173837,"Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.","[{'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Chatziralli', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece. eirchat@yahoo.gr.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Dimitriou', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazantzis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}]",Acta diabetologica,['10.1007/s00592-020-01548-y']
1193,32472263,"Functional outcome after corrective osteotomy for malunion of the distal radius: a randomised, controlled, double-blind trial.","PURPOSE


The purpose of this randomised, controlled, double-blind trial was to evaluate functional outcome during the first year after corrective osteotomy for malunited distal radius fractures, with or without filling the osteotomy void.
METHOD


Patients were randomised to receive a HydroSet bone substitute or no graft. Cortical contact was maintained and stabilisation of the osteotomy was carried out with a DiPhos R- or RM Plate. To evaluate subjective functional outcome, the Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH), the Canadian Occupational Performance Measure (COPM) and the RAND-36 were used. Moreover, range of motion and grip strength were measured by blinded evaluators. Evaluations were made pre-operatively and three, six and 12 months post-operatively.
RESULTS


There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05). In both groups, there was a significant improvement at the 12-month follow-up compared with pre-operatively for the PRWE, the Q-DASH and the COPM satisfaction scores. The RAND-36 revealed no significant differences except for two domains, in which there was an improvement in the treatment group (p < 0.05). For grip strength and for range of motion in all movement directions, except dorsal extension, there was a significant improvement in both groups (p < 0.05).
CONCLUSION


There is no significant difference in functional outcome during the first year after corrective open-wedge distal radius osteotomy, where cortical contact is maintained, regardless of whether or not bone substitute to fill the void is used.",2020,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"['malunion of the distal radius', 'Patients']","['HydroSet bone substitute or no graft', 'corrective osteotomy']","['range of motion or grip strength', 'functional outcome', 'Patient-Rated Wrist Evaluation (PRWE), the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire ', 'range of motion and grip strength', 'COPM satisfaction scores', 'Canadian Occupational Performance Measure (COPM']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",,0.070651,There were no significant differences between the groups at any time point post-operatively with respect to any of the PROMs that were used or range of motion or grip strength (p > 0.05).,"[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Andreasson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Ingrid.f.andreasson@vgregion.se.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Kjellby-Wendt', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Fagevik Olsén', 'Affiliation': 'Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Mölndalsvägen 31, SE-431 80, Mölndal, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Aurell', 'Affiliation': 'Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ullman', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jón', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",International orthopaedics,['10.1007/s00264-020-04605-x']
1194,32488793,"Associations Between Gender, Resiliency Factors, and Anxiety in Neuro-ICU Caregivers: a Prospective Study.","BACKGROUND


Informal caregivers of patients admitted to the neuroscience intensive care unit (Neuro-ICU) are at risk for developing chronic anxiety. Resiliency factors may reduce risk, yet their differential effects for female and male caregivers have not been studied in this population. We aim to examine interactions between gender and baseline resiliency factors and anxiety at baseline, 3 months, and 6 months.
METHOD


Prospectively studied caregivers (N = 96) of patients admitted to the Neuro-ICU completed baseline sociodemographics and resiliency measures (coping, mindfulness, self-efficacy, intimate care, and caregiver preparedness), and anxiety severity at baseline (hospitalization), 3 months, and 6 months.
RESULTS


Baseline anxiety predicted future anxiety (3 and 6 months). Caregivers who reported high (versus low) baseline coping, mindfulness, self-efficacy, and preparedness for caregiving reported lower baseline anxiety (ps ≤ 0.012). An interaction between caregiver gender and baseline mindfulness was seen at 3 months (p = 0.021), with high mindfulness males reporting lower anxiety than high mindfulness females, and low mindfulness males reporting higher anxiety than low mindfulness females.
CONCLUSION


Results emphasize the protective role of resilience in the trajectory of anxiety among informal caregivers. Findings emphasize the need to rapidly deploy skills-based treatment to Neuro-ICU caregivers to prevent future development and maintenance of anxiety, specifically emphasizing mindfulness in male caregivers.",2020,"An interaction between caregiver gender and baseline mindfulness was seen at 3 months (p = 0.021), with high mindfulness males reporting lower anxiety than high mindfulness females, and low mindfulness males reporting higher anxiety than low mindfulness females.
","['Informal caregivers of patients admitted to the neuroscience intensive care unit (Neuro-ICU', 'Prospectively studied caregivers (N\u2009=\u200996) of patients admitted to the Neuro-ICU completed baseline sociodemographics and resiliency measures (coping, mindfulness, self-efficacy, intimate care, and caregiver preparedness), and anxiety severity at baseline (hospitalization), 3\xa0months, and 6\xa0months', 'female and male caregivers', 'male caregivers']",[],[],"[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],[],,0.0243065,"An interaction between caregiver gender and baseline mindfulness was seen at 3 months (p = 0.021), with high mindfulness males reporting lower anxiety than high mindfulness females, and low mindfulness males reporting higher anxiety than low mindfulness females.
","[{'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Ilyssa H', 'Initials': 'IH', 'LastName': 'Silverman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, USA. avranceanu@mgh.harvard.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09907-3']
1195,32445440,Remdesivir for the Treatment of Covid-19 - Final Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).
CONCLUSIONS


Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1196,32464334,"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial.","OBJECTIVES


The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.
METHODS


Data from 3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.
RESULTS


Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
CONCLUSIONS


Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.",2020,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","['3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18', 'young women', 'adult women ages 24 to 45 participating in a vaccine trial', 'adult women']","['9vHPV vaccine', 'anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59', 'vaccine']","['Overall, HPV incidence', 'incidence of persistent infection', 'Prevalence of anogenital infection', 'Prevalence, incidence, and natural history of HPV infection', 'HPV-related morbidity and mortality', 'Incidence of infections and persistent infections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3817.0,0.148337,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","[{'ForeName': 'Daron G', 'Initials': 'DG', 'LastName': 'Ferris', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Cancer Center, 1120 15th Street, Augusta University, Augusta, GA, 30912, USA. Electronic address: dferris@augusta.edu.'}, {'ForeName': 'Darron R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Van Nuys Medical Science Building, Suite 224, 635 Barnhill Drive, Indianapolis, IN 46202, USA. Electronic address: darbrow@iupui.edu.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA. Electronic address: Anna.Giuliano@moffitt.org.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Duke Medicine Cir, Durham, NC, 27710, USA. Electronic address: evan.myers@duke.edu.'}, {'ForeName': 'Elmar A', 'Initials': 'EA', 'LastName': 'Joura', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Weinheimergrass 2, Medical University of Vienna, Vienna, 1160, Austria. Electronic address: elmar.joura@gmail.com.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Centre for Women's Infectious Diseases, The Royal Women's Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Children's Research Institute, RWH, Locked Bag 300, Cnr Gratton St and Flemington Rd, Parkville, Victoria, 3052, Australia. Electronic address: Suzanne.Garland@thewomens.org.au.""}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen Denmark and Department of Gynecology, Rigshospitalet, Blegdamsvej 9, University of Copenhagen, Copenhagen, 2200, Denmark. Electronic address: susanne@cancer.dk.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: gonzalopamaya@gmail.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alain_luxembourg@merck.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Velicer', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: christine_velicer@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100202']
1197,32482616,Ticagrelor alone or conventional dual antiplatelet therapy in patients with stable or acute coronary syndromes.,"AIMS


The aim of this study was to investigate the effect of ticagrelor monotherapy after one-month dual antiplatelet therapy (DAPT) or conventional DAPT in patients with or without acute coronary syndrome (ACS) in the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY).
METHODS AND RESULTS


Risk estimates were expressed as rate ratios (RR) with 95% confidence intervals (CI). A total of 3,840 ACS and 3,745 stable ischaemic heart disease (SIHD) patients were included. At two years, rates of the co-primary efficacy endpoint, a composite of death, myocardial infarction, stroke or urgent target vessel revascularisation, were 7.94% in the experimental and 9.68% in the control group (RR 0.82, 95% CI: 0.66-1.01) among ACS patients and 6.31% in the experimental and 7.14% in the control group (RR 0.89, 95% CI: 0.69-1.13) among SIHD patients (pint=0.63). Trends for lower and higher risk of BARC 3 or 5 bleeding with the experimental strategy in ACS (2.27% vs 3.00%, RR 0.76, 95% CI: 0.51-1.12) and SIHD (2.70% vs 1.96%, RR 1.39, 95% CI: 0.91-2.12) patients, respectively, were observed with significant interaction testing (pint=0.039). A net clinical benefit endpoint, the composite of both co-primary study endpoints, favoured the experimental treatment among ACS patients only.
CONCLUSIONS


Ticagrelor monotherapy after one-month DAPT provided consistent treatment effects on ischaemic endpoints in patients with or without ACS but only the former experienced a net clinical benefit. ClinicalTrials.gov identifier: NCT03231059.",2020,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","['patients with stable or acute coronary syndromes', 'patients with or without acute coronary syndrome (ACS', '3,745 SIHD (stable ischemic heart disease', 'patients with or without ACS']","['Ticagrelor alone or conventional dual antiplatelet therapy', 'ticagrelor monotherapy', 'antiplatelet therapy (DAPT) or conventional DAPT']","['rate ratios (RR', 'rates of co-primary efficacy endpoint, composite of death, myocardial infarction, stroke or urgent target-vessel revascularization', 'ischemic endpoints', 'SIHD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]",,0.0916424,"A net clinical benefit endpoint, composite of both co-primary study endpoints, favored the experimental treatment among ACS patients only.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Franzone', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Eugène P', 'Initials': 'EP', 'LastName': 'McFadden', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': ''}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': ''}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': ''}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Branca', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00145']
1198,32487982,Oxidative stress does not influence weight loss induced by aerobic training in adults: randomized clinical trials.,"BACKGROUND


High levels of oxidative stress promote degradation of the cell membrane impairing cellular function in fat oxidation. However, the influence of oxidative stress on exercise-induced weight-loss has not yet been investigated. Therefore, the aim of this study was to verify the influence of a lipidic peroxidation marker (malondialdehyde, MDA) and antioxidant status (total antioxidant capacity marker, TAC) on the magnitude of weight-loss by aerobic-induced exercise in previously sedentary overweight or obese individuals.
METHODS


Seventy-five physically inactive adults were randomized into experimental (N.=58) and control (N.=17) groups, who engaged in a 12-week program of aerobic training walking and/or running (3 to 5 days/week) or stretching (1 day/week), respectively. Body composition (DXA), aerobic capacity (ergospirometric) and blood collections for oxidative stress analysis (MDA and TAC) were determined before and after the experimental protocol. Two-way ANOVA for repeated measures or Friedman's test were used to evaluate differences in time/group interaction. Pearson correlation was used to verify the relationship between the variables of oxidative stress and of body composition.
RESULTS


Significant reduction was found in fat body mass of experimental when compared to control group (-1.3±1.9 kg versus -0.3±1.3, P=0.04). Experimental group also altered significantly the total body mass (-1.2±4.7 kg; effect size 0.44), body mass index - BMI (-0.3±1.1 effect size 0.37), fat percentage (1.3±1.6%; effect size 0.50) and lean body mass (0.6±1.5 kg; effect size 0.32).There was increase in MDA of 2.3 μmol/L to 2.7 μmol/L (P=0.00), without changes to TAC (25.6±13.9% to 28.0±10.4%). No correlation was found between these variations in body composition with either the initial values of MDA and TAC or delta variation of these indicators of oxidative stress in response to the training program.
CONCLUSIONS


Indicators of oxidative stress (MDA and TAC) does not influence the magnitude of weight-loss induced by aerobic training.",2020,"CONCLUSIONS


Indicators of oxidative stress (MDA and TAC) does not influence the magnitude of weight-loss induced by aerobic training.","['Seventy-five physically inactive adults', 'adults', 'previously sedentary overweight or obese individuals']","['aerobic training walking and/or running', 'aerobic training', 'aerobic-induced exercise']","['weight-loss', 'Body composition (DXA), aerobic capacity (ergospirometric) and blood collections for oxidative stress analysis (MDA and TAC', 'fat body mass', 'total body mass', 'lipidic peroxidation marker (malondialdehyde, MDA) and antioxidant status (total antioxidant capacity marker, TAC', 'lean body mass', 'body mass index - BMI', 'weight loss', 'MDA', 'fat percentage']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",75.0,0.0300175,"CONCLUSIONS


Indicators of oxidative stress (MDA and TAC) does not influence the magnitude of weight-loss induced by aerobic training.","[{'ForeName': 'Glêbia A', 'Initials': 'GA', 'LastName': 'Cardoso', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Mateus D', 'Initials': 'MD', 'LastName': 'Ribeiro', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Yohanna', 'Initials': 'Y', 'LastName': 'de Oliveira', 'Affiliation': 'Federal University of Paraíba (PPGCN/UFPB), João Pessoa, PB, Brazil.'}, {'ForeName': 'Thiago de O', 'Initials': 'TO', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'de Sousa', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Reabias de A', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Antônio E', 'Initials': 'AE', 'LastName': 'de Almeida', 'Affiliation': 'Lauro Wanderley University Hospital - HULW-Federal University of Paraíba - UFPB, João Pessoa, PB, Brazil.'}, {'ForeName': 'João M', 'Initials': 'JM', 'LastName': 'Filho', 'Affiliation': 'Lauro Wanderley University Hospital - HULW-Federal University of Paraíba - UFPB, João Pessoa, PB, Brazil.'}, {'ForeName': 'Raquel S', 'Initials': 'RS', 'LastName': 'Brito Silva', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Applied Studies in Physical Training to Performance and Health - LETFADS, Department of Physical Education, Federal University of Paraíba, João Pessoa, PB, Brazil - alexandresergiosilva@yahoo.com.br.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10528-0']
1199,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND


Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking.
RESEARCH QUESTION


Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters.
METHODS


This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments.
RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain.
SIGNIFICANCE


This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS


Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030']
1200,32586293,"A blended intervention to promote physical activity, health and work productivity among office employees using intervention mapping: a study protocol for a cluster-randomized controlled trial.","BACKGROUND


Regular participation in moderate-to-vigorous physical activity (MVPA) is related to decreased risk of morbidity and mortality. Among working populations, lack of MVPA may also be a risk factor for absenteeism and presenteeism. Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity. However, several challenges limit their application in real world contexts. A 'blended' intervention approach combining the two intervention strategies is proposed to overcome these limitations. The proposed intervention aims to utilize the blended approach to increase participation in MVPA, health-related outcomes, and work productivity among inactive workers.
METHODS


The study will comprise of a three-group cluster randomized controlled trial (cluster-RCT), comprising a three-month actual intervention and a nine-month behavioral follow-up period. The three groups will be: a web-based intervention group, a blended intervention group combining the web-based components with face-to-face workshops and posters, and a control group. Physically inactive office employees (N = 495) from 33 companies (i.e., clusters) will be recruited and randomly assigned to the three groups by cluster randomization. The intervention mapping (IM) framework will be used for selecting and applying effective health behavioral theories and behavioral change techniques (BCTs) to the development, implementation and assessment of the intervention, which will be personally tailored. The primary outcome variable will be objectively-measured MVPA using an accelerometer. Secondary outcomes will consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, health-related quality of life and work-related variables including absenteeism and presenteeism.
DISCUSSION


The proposed study adopts a robust blended intervention approach that is expected to overcome challenges in applying workplace-based and web-based interventions separately and yield larger effects in promoting MVPA participation, health-related outcomes and work productivity. Improvements in work productivity outcomes will be of particular interest to employers. If more effective, the new blended intervention has the potential to be implemented on a larger scale to benefit workplace populations.
TRIAL REGISTRATION


The trial is prospectively registered at the ClinicalTrials.gov PRS (Trial ID: NCT04391270; Date of First Posted: May 18, 2020).",2020,"Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity.","['Physically inactive office employees (N\u2009=\u2009495) from 33 companies (i.e., clusters']","['blended intervention group combining the web-based components with face-to-face workshops and posters, and a control group']","['consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, health-related quality of life and work-related variables including absenteeism and presenteeism', 'objectively-measured MVPA using an accelerometer']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0879274,"Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Aiwei', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Siyue', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'Psychological Sciences, University of California, Merced, CA, USA.'}, {'ForeName': 'Xiangyan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Shirley Siu Ming', 'Initials': 'SSM', 'LastName': 'Fong', 'Affiliation': 'Department of Health and Physical Education, Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Wendy Yajun', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, University Hospital of Clermont-Ferrand, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China. gaoyang@hkbu.edu.hk.'}]",BMC public health,['10.1186/s12889-020-09128-z']
1201,32589290,Sitting decreases endothelial microparticles but not circulating angiogenic cells irrespective of lower leg exercises: a randomized cross-over trial.,"NEW FINDINGS


What is the central question of this study? What are the cellular and molecular determinants of increased risk for cardiovascular disease from prolonged sitting? What is the main finding and its importance? Prolonged sitting, independent of calf raise interruption strategies, decreases microparticle counts linked to endothelial activation and apoptosis. An acute bout of prolonged sitting appears to promote paradoxical decreases in microparticle counts, but the implications are not yet clear.
ABSTRACT


Repeated exposure to prolonged sitting increases the risk for cardiovascular disease. However, the cellular links by which repeated exposure to prolonged sitting lead to increased cardiovascular risk have not been fully elucidated, with markers of vascular damage and repair such as microparticles (MPs) and circulating angiogenic cell (CACs) being promising targets. The objective of the study was to examine the effects of 3 h of sitting with or without intermittent calf raises on annexin V +  /CD34 +  , annexin V +  /CD62E +  , and annexin V +  /CD31 +  /42b -  MP populations linked to CAC paracrine activity, endothelial activation and apoptosis, respectively, as well as CD14 +  /31 +  , CD3 +  /31 +  , and CD34 +  CACs, which are linked to endothelial repair. In a random order, 20 sedentary participants (14 females, 22 ± 3 years) remained seated for 180 min with or without performing 10 calf raises every 10 min. Blood samples were obtained after 20 min of quiet rest in the supine position before and after sitting. Overall, sitting decreased annexin V +  /CD34 +  MPs (-12 ± 5 events µl -1  , P < 0.01), annexin V +  /CD62E +  MPs (-17 ± 4 events µl -1  , P < 0.001), and annexin V +  /CD31 +  /42b -  MPs (-22 ± 6 events µl -1  , P < 0.001) regardless of condition. There were no differences in endothelin-1 plasma concentration, CD14 +  /31 +  , CD34 +  or CD3 +  /31 +  CAC frequencies. Sitting did not alter CAC number, but decreased MPs linked to endothelial activation, apoptosis and CAC paracrine activity in a manner that was independent of muscle contraction. These findings support changes in markers of endothelial activation and apoptosis with sedentary behaviour and provide new insights into altered intercellular communication with physical inactivity such as prolonged sitting.",2020,"There were no differences in endothelin-1 plasma concentration, CD14 +  /31 +  , CD34 +  or CD3 +  /31 +  CAC frequencies.","['20 sedentary participants (14 females, 22\xa0±\xa03 years) remained seated for 180 minutes with or without performing 10 calf raises every 10 minutes']","['3\xa0h of sitting with or without intermittent calf raises on Annexin V +  /CD34 +  , Annexin V +  /CD62E +  , and Annexin V +  /CD31']","['endothelin-1 plasma concentration', 'MPs linked to endothelial activation, apoptosis and CAC paracrine activity', 'sitting decreased Annexin V +  /CD34 +  MPs (-12\xa0±\xa05 events/μl, P\xa0<\xa00.01), Annexin V +  /CD62E +  MPs']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0585315', 'cui_str': 'Every ten minutes'}]","[{'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}]","[{'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0059249', 'cui_str': 'Annexin V'}, {'cui': 'C4517393', 'cui_str': '0.01'}]",20.0,0.029173,"There were no differences in endothelin-1 plasma concentration, CD14 +  /31 +  , CD34 +  or CD3 +  /31 +  CAC frequencies.","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Evans', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Shill', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, 20740, USA.'}, {'ForeName': 'Rian Q', 'Initials': 'RQ', 'LastName': 'Landers-Ramos', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, MD, 21252.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Willey', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology and Nutrition, University of Southern Mississippi, Hattiesburg, MS, 39406, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Prior', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, 20740, USA.'}]",Experimental physiology,['10.1113/EP088690']
1202,32584651,The Effect of Temporal Frames in Anti-Smoking Messages on the Extension of Anti-Smoking Arguments to Smokers.,"The present study focused on how exposure to different health message characteristics can affect extension-i.e., the sharing of arguments that were not targeted by the messages but are consistent with the message theme. In the context of anti-smoking campaigns, many messages have either emphasized reasons to quit smoking (why-quit) or ways to quit smoking (how-to-quit). Therefore, guided by construal level theory, the study aimed to examine whether the message characteristic of temporal frames can increase or decrease extension when incorporated into why-quit and how-to-quit anti-smoking messages. Results from a randomized experiment showed that exposure to why-quit messages with distant temporal frames increased extension (vs. no-message control) while why-quit messages with proximal temporal frames did not. Findings further illustrated a potential mechanism, where why-quit messages with proximal frames significantly reduced extension compared to why-quit messages with no temporal frames. Temporal frames did not have a significant effect on extension for how-to-quit messages. Results indicate that emphasizing the present in anti-smoking messages could be detrimental for the extension of why-quit arguments. Implications for applying construal level theory to health message effects research are also discussed.",2020,Temporal frames did not have a significant effect on extension for how-to-quit messages.,['Smokers'],[],[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],[],,0.0409015,Temporal frames did not have a significant effect on extension for how-to-quit messages.,"[{'ForeName': 'Stella Juhyun', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Media and Communication, Konkuk University , Seoul, Republic of Korea.'}]",Journal of health communication,['10.1080/10810730.2020.1778820']
1203,32459919,Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.,"BACKGROUND


Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19).
METHODS


We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale.
RESULTS


In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
CONCLUSIONS


In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).",2020,"By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group.","['patients with severe Covid-19 not requiring mechanical ventilation', 'hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia', 'Patients with Severe Covid-19', '397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days']",['intravenous remdesivir'],"['worsening respiratory failure', 'ordinal scale', 'distribution in clinical status', 'clinical status on day 14, assessed on a 7-point ordinal scale', 'elevated alanine aminotransferase level', 'nausea', 'constipation', 'clinical status', 'median duration of treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",397.0,0.213119,"By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Goldman', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'David C B', 'Initials': 'DCB', 'LastName': 'Lye', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Marks', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Montejano', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Mi-Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Nahass', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Yao-Shen', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Towner', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Karen T', 'Initials': 'KT', 'LastName': 'Tashima', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Diaz', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Subramanian', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015301']
1204,31828050,"A Prospective, Randomized Comparison of Duodenoscope Reprocessing Surveillance Methods.","Duodenoscope use in healthcare facilities has been associated with transmission of multidrug resistant pathogens between patients. To assist healthcare facilities in monitoring the quality of their duodenoscope reprocessing procedures and limit patient risk of infection, the Centers for Disease Control and Prevention (CDC) deployed voluntary interim duodenoscope sampling and culturing surveillance protocols in 2015. Though the interim methods were widely adopted, alternative surveillance protocols were developed and implemented at individual institutions. Here, we compared two sampling methods-the 2015 CDC interim protocol and an alternative protocol developed by the University of Wisconsin Hospitals and Clinics (UWHC). We hypothesized that the UWHC protocol would detect a higher incidence of bacterial contamination from reprocessed duodenoscopes. A total of 248 sampling events were performed at UWHC. The CDC protocol ( n  = 129 sampling events) required culturing samples collected from each duodenoscope after brushing its terminal end and flushing its lumen with sterile water. The UWHC protocol ( n  = 119 sampling events) required culturing samples collected from each duodenoscope after swabbing its elevator, immersing its terminal end into broth and flushing its lumen with saline. With the CDC method, 8.53% ( n  = 11) of the duodenoscopes sampled were positive for bacterial growth with 15 isolates recovered. Using the UWHC method, 15.13% ( n  = 18) of cultures were positive for bacterial growth with 20 isolates recovered. The relative risk of identifying a contaminated duodenoscope using the CDC interim method, however, was not different than when using the UWHC protocol. Mean processing time (27.35 and 5.11 minutes,  p  < 0.001) and total cost per sample event ($17.87 and $15.04) were lower using the UWHC method. As the UWHC protocol provides similar detection rates as the CDC protocol, the UWHC method is useful, provided the shorter processing time and lower cost to perform.",2019,"Using the UWHC method, 15.13% ( n  = 18) of cultures were positive for bacterial growth with 20 isolates recovered.",[],[],"['total cost per sample event', 'Mean processing time']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0241301,"Using the UWHC method, 15.13% ( n  = 18) of cultures were positive for bacterial growth with 20 isolates recovered.","[{'ForeName': 'Travis J', 'Initials': 'TJ', 'LastName': 'De Wolfe', 'Affiliation': 'Department of Biomedical Informatics, University of Pittsburgh School of Medicine, Pittsburgh 15219, PA, USA.'}, {'ForeName': 'Nasia', 'Initials': 'N', 'LastName': 'Safdar', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison, Madison 53705, WI, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Meller', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison, Madison 53705, WI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marx', 'Affiliation': 'Infection Control, University of Wisconsin Hospitals and Clinics, Madison 53705, WI, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Pfau', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Nelsen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Benson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Soni', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reichelderfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Duster', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison, Madison 53705, WI, USA.'}, {'ForeName': 'Deepak V', 'Initials': 'DV', 'LastName': 'Gopal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison 53705, WI, USA.'}]",Canadian journal of gastroenterology & hepatology,['10.1155/2019/1959141']
1205,32489115,The Use of Eye Tracking to Discern the Threshold at Which Metopic Orbitofrontal Deformity Attracts Attention.,"INTRODUCTION AND OBJECTIVES


Surgical treatment for trigonocephaly aims to eliminate a stigmatizing deformity, yet the severity that captures unwanted attention is unknown. Surgeons intervene at different points of severity, eliciting controversy. This study used eye tracking to investigate when deformity is perceived.
MATERIAL AND METHODS


Three-dimensional photogrammetric images of a normal child and a child with trigonocephaly were mathematically deformed, in 10% increments, to create a spectrum of 11 images. These images were shown to participants using an eye tracker. Participants' gaze patterns were analyzed, and participants were asked if each image looked ""normal"" or ""abnormal.""
RESULTS


Sixty-six graduate students were recruited. Average dwell time toward pathologic areas of interest (AOIs) increased proportionally, from 0.77 ± 0.33 seconds at 0% deformity to 1.08 ± 0.75 seconds at 100% deformity ( P  < .0001). A majority of participants did not agree an image looked ""abnormal"" until 90% deformity from any angle.
CONCLUSION


Eye tracking can be used as a proxy for attention threshold toward orbitofrontal deformity. The amount of attention toward orbitofrontal AOIs increased proportionally with severity. Participants did not generally agree there was ""abnormality"" until deformity was severe. This study supports the assertion that surgical intervention may be best reserved for more severe deformity.",2020,"Average dwell time toward pathologic areas of interest (AOIs) increased proportionally, from 0.77 ± 0.33 seconds at 0% deformity to 1.08 ± 0.75 seconds at 100% deformity ( P  < .0001).","['Sixty-six graduate students', 'Participants\' gaze patterns were analyzed, and participants were asked if each image looked ""normal"" or ""abnormal', 'Three-dimensional photogrammetric images of a normal child and a child with trigonocephaly were mathematically deformed, in 10% increments, to create a spectrum of 11 images']",[],"['amount of attention toward orbitofrontal AOIs', 'Average dwell time toward pathologic areas of interest (AOIs']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0265535', 'cui_str': 'Trigonocephaly'}]",[],"[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}]",,0.068858,"Average dwell time toward pathologic areas of interest (AOIs) increased proportionally, from 0.77 ± 0.33 seconds at 0% deformity to 1.08 ± 0.75 seconds at 100% deformity ( P  < .0001).","[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Pressler', 'Affiliation': 'Department of Plastic Surgery, 12334UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Geisler', 'Affiliation': 'Department of Plastic Surgery, 12334UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Rami R', 'Initials': 'RR', 'LastName': 'Hallac', 'Affiliation': 'Department of Plastic Surgery, 12334UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Seaward', 'Affiliation': 'Department of Plastic Surgery, 12334UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Kane', 'Affiliation': 'Department of Plastic Surgery, 12334UT Southwestern, Dallas, TX, USA.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620926014']
1206,32580655,Comparison of Outcome Adjudication by Investigators and by a Central End Point Committee in Heart Failure Trials: Experience of the SHIFT Heart Failure Study.,"BACKGROUND


The usefulness of adjudication by central end point committees (CECs) is poorly assessed in heart failure (HF) trials. We aimed to assess its impact on the outcome of the SHIFT trial (Systolic HF Treatment With the If Inhibitor Ivabradine Trial).
METHODS


SHIFT was a randomized placebo-controlled trial investigating the effect of ivabradine in 6505 HF patients with reduced ejection fraction. Prespecified end points, reported by investigators (all cardiologists) using specific case report form pages, included all-cause and specific causes of deaths and hospitalizations. The primary end point was a composite of cardiovascular deaths or hospitalizations for worsening HF. We compared the adjudication of prespecified end points made by investigators and by the CEC.
RESULTS


Investigators identified 7529 prespecified end points, 6793 of which were confirmed by the CEC: 98.1% of cardiovascular deaths, 88.6% of all hospitalizations, and 84.4% of hospitalizations for worsening HF. These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83 (95% CI, 0.76-0.91) versus CEC, 0.82 (95% CI, 0.75-0.90), with similar results for each component of the primary end point (hazard ratio of 0.92 versus 0.91 for cardiovascular death and 0.78 versus 0.74 for hospitalization for worsening HF).
CONCLUSIONS


Central adjudication by a CEC in the SHIFT study confirmed most of cardiovascular deaths and worsening HF hospitalizations assessed by cardiologists and did not result in a significant change of the final result as compared to investigator judgment. In this context, the benefits of CEC in blinded HF trials should be reconsidered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02441218. URL: http://www.isrctn.com/ISRCTN70429960; Unique identifier: ISRCTN70429960.",2020,"These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83",['6505 HF patients with reduced ejection fraction'],"['ivabradine', 'placebo']","['cardiovascular deaths', 'cardiovascular deaths and worsening HF hospitalizations', 'composite of cardiovascular deaths or hospitalizations for worsening HF']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",6505.0,0.254635,"These differences had no meaningful impact on the study results; hazard ratio for the primary composite end point: investigators, 0.83","[{'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tyl', 'Affiliation': 'CardioVascular & Metabolic Disease Center for Therapeutic Innovation (B.T., C.V.), Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lopez Sendon', 'Affiliation': 'Cardiology Department (J.L.S.), University Hospital La Paz, UAM, IdiPaz, CiberCV, Madrid, Spain.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Borer', 'Affiliation': 'College of Medicine, School of Public Health, SUNY Downstate Medical Center, Brooklyn, New York (J.S.B.).'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Lopez De Sa', 'Affiliation': 'Acute Cardiac Care Unit (E.L.D.S.), University Hospital La Paz, UAM, IdiPaz, CiberCV, Madrid, Spain.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Lerebours', 'Affiliation': 'Health Value 92, Levallois-Perret, France (G.L.).'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Varin', 'Affiliation': 'CardioVascular & Metabolic Disease Center for Therapeutic Innovation (B.T., C.V.), Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'De Montigny', 'Affiliation': 'Center of Excellence Methodology and Valorisation of Data (A.D.M., M.P.), Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Pannaux', 'Affiliation': 'Center of Excellence Methodology and Valorisation of Data (A.D.M., M.P.), Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': 'Department of Cardiology, Hospital Saint Joseph, Paris, France (M.K.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006720']
1207,32588401,Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial.,"BACKGROUND


Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, improved wakefulness and reduced excessive daytime sleepiness (EDS) in studies of participants with narcolepsy with and without cataplexy.
OBJECTIVE


Prespecified subgroup analyses of data from a 12-week randomized, double-blind, placebo-controlled, phase III trial of solriamfetol for EDS in narcolepsy evaluated the efficacy and safety of solriamfetol by cataplexy status.
METHODS


Participants with narcolepsy received solriamfetol (75, 150, or 300 mg/day) or placebo and were stratified by cataplexy status. Coprimary endpoints were change from baseline on Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS); Patient Global Impression of Change (PGI-C) was the key secondary endpoint. Change in frequency of cataplexy attacks was evaluated in participants reporting cataplexy at baseline. Safety was evaluated. No adjustments were made for multiple comparisons; therefore p values are nominal.
RESULTS


There were 117 participants in the cataplexy subgroup and 114 in the non-cataplexy subgroup. At week 12, least-squares (LS) mean (95% confidence interval [CI]) differences from placebo on change from baseline in MWT for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup were 1.6 (- 3.6 to 6.9), 6.1 (0.7-11.4), and 8.9 (3.5-14.2) minutes, respectively (p < 0.05; 150 and 300 mg), and in the non-cataplexy subgroup were 3.4 (- 1.9 to 8.7), 9.1 (3.8-14.3), and 11.2 (5.8-16.6) minutes, respectively (p < 0.001; 150 and 300 mg). At week 12, LS mean (95% CI) differences from placebo on ESS change from baseline for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup were - 1.3 (- 3.9 to 1.3), - 3.7 (- 6.4 to - 1.1), and - 4.5 (- 7.1 to - 1.9), respectively (p < 0.01; 150 and 300 mg), and in the non-cataplexy subgroup were - 3.0 (- 5.6 to - 0.4), - 3.7 (- 6.3 to - 1.2), and - 4.9 (- 7.6 to - 2.2), respectively (p < 0.05; all doses). For PGI-C at week 12, the mean percentage difference from placebo (95% CI) for solriamfetol 75, 150, and 300 mg in the cataplexy subgroup was 10% (- 15 to 35), 33% (9-57), and 39% (16-61), respectively (p < 0.05; 150 and 300 mg), and in the non-cataplexy subgroup was 48% (25-70), 44% (21-67), and 52% (30-73), respectively (p < 0.001; all doses), with somewhat differential treatment effects for 75 mg by cataplexy status. No changes in the number of cataplexy attacks were observed for solriamfetol compared with placebo (mean ± standard deviation changes: - 3.6 ± 13.3 [combined solriamfetol] and - 3.5 ± 9.8 [placebo]). Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups.
CONCLUSIONS


These data strongly indicate that solriamfetol was effective in treating EDS in participants with narcolepsy with or without cataplexy, as indicated by robust effects on MWT, ESS, and PGI-C. The safety profile was similar regardless of cataplexy status.
TRIAL REGISTRATION AND DATE


ClinicalTrials.gov NCT02348593. 28 January 2015.",2020,"Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups.
","['117 participants in the cataplexy subgroup and 114 in the non-cataplexy subgroup', 'participants with narcolepsy with and without cataplexy', 'Participants with Narcolepsy with and without Cataplexy', 'Participants with narcolepsy received solriamfetol (75, 150, or 300\xa0mg/day) or', 'participants with narcolepsy with or without cataplexy', '28 January 2015']",['placebo'],"['Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis', 'number of cataplexy attacks', 'Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS); Patient Global Impression of Change (PGI-C', 'excessive daytime sleepiness (EDS', 'ESS change', 'Excessive Daytime Sleepiness', 'frequency of cataplexy attacks']","[{'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0303405', 'cui_str': 'Indium-114'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C4726765', 'cui_str': 'Solriamfetol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007384', 'cui_str': 'Cataplexy'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.426224,"Common adverse events (headache, nausea, decreased appetite, and nasopharyngitis) were similar between cataplexy subgroups.
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Département de Neurologie, Centre National de Référence Narcolepsie Hypersomnies Inserm U1061, CHU Gui-de-Chauliac, University of Montpellier, 80, Avenue Augustin Fliche, 34295, Montpellier Cedex 5, France. y-dauvilliers@chu-montpellier.fr.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Shapiro', 'Affiliation': 'UHN-Toronto Western Hospital, University of Toronto, 399 Bathurst St, MP7, 421, Medical Sciences, Toronto, ON, M5T 2S8, Canada.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schimmelpfengstraße 6, 34613, Schwalmstadt, Germany.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep and Wake Disorders, 5454 Wisconsin Ave, Suite 1725, Chevy Chase, MD, 20815, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Jazz Pharmaceuticals, 3170 Porter Drive, Palo Alto, CA, 94304, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Montefiore Medical Center, 111 East 210th Street, Bronx, NY, 10467-2509, USA.'}]",CNS drugs,['10.1007/s40263-020-00744-2']
1208,32478922,"The effects of garlic (Allium sativum) supplementation on inflammatory biomarkers, fatigue, and clinical symptoms in patients with active rheumatoid arthritis: A randomized, double-blind, placebo-controlled trial.","Based on the antiinflammatory properties of garlic, current study was conducted to evaluate the garlic supplement effects on serum levels of some inflammatory biomarkers, clinical symptoms, and fatigue in women with active rheumatoid arthritis. In this randomized, double-blind, placebo-controlled trial study, 70 women with RA were randomly divided into two groups: The intervention group was supplemented with 1,000 mg of garlic, and the control group received placebo for 8 weeks. At baseline and at the end of the study, clinical symptoms, fatigue, serum level of C-reactive protein (CRP), tumor necrosis factor-a (TNF-a), and erythrocyte sedimentation rate (ESR) were determined. After intervention, serum levels of CRP (p = .018) and TNF-a (p < .001) decreased significantly in the garlic group as compared with the placebo group. Also, pain intensity, tender joint count, disease activity score (DAS-28), and fatigue were significantly decreased in the intervention group compared with the control group (p < .001; for all). Swollen joint count was significantly decreased in the garlic group (p < .001), but not in the placebo group (p = .123). No significant changes were observed for ESR. Garlic supplementation by improving inflammatory mediators and clinical symptoms can be considered as a potential adjunct treatment in patients with RA. However, further studies with larger duration are needed.",2020,"After intervention, serum levels of CRP (p = .018) and TNF-a (p < .001) decreased significantly in the garlic group as compared with the placebo group.","['patients with active rheumatoid arthritis', 'women with active rheumatoid arthritis', 'patients with RA', '70 women with RA']","['garlic (Allium sativum) supplementation', 'Garlic supplementation', 'intervention group was supplemented with 1,000\u2009mg of garlic, and the control group received placebo', 'placebo']","['inflammatory biomarkers, fatigue, and clinical symptoms', 'serum levels of some inflammatory biomarkers, clinical symptoms, and fatigue', 'Swollen joint count', 'ESR', 'serum levels of CRP', 'pain intensity, tender joint count, disease activity score (DAS-28), and fatigue', 'clinical symptoms, fatigue, serum level of C-reactive protein (CRP), tumor necrosis factor-a (TNF-a), and erythrocyte sedimentation rate (ESR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0993630', 'cui_str': 'Garlic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",70.0,0.447113,"After intervention, serum levels of CRP (p = .018) and TNF-a (p < .001) decreased significantly in the garlic group as compared with the placebo group.","[{'ForeName': 'Seyedeh Parisa', 'Initials': 'SP', 'LastName': 'Moosavian', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zamzam', 'Initials': 'Z', 'LastName': 'Paknahad', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Habibagahi', 'Affiliation': 'Department of Rheumatology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Maracy', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6723']
1209,32483678,Treatment of avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma: a prospective not controlled study.,"PURPOSE


Core decompression is a surgical option since the 1960s for hip osteonecrosis treatment. This technique promotes bone repair by reducing intramedullary pressure, but this is not often enough to stop the progression of necrosis. The aim of this study was to associate core decompression with the regenerative stimulus provided by platelet-rich plasma (PRP) and compare our results with other regenerative techniques.
METHODS


Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60 years) treated by core decompression and PRP graft. Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification. The outcome was assessed by changes in Harris Hip Score (HHS) and the need for total hip replacement (THA).
RESULTS


The mean preoperative HHS was 64 points, at two years from surgery was roughly 84 points. Sixteen of 30 hips showed osteonecrosis progression of the femoral head and were converted to THA. At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively.
CONCLUSION


Core decompression combined with PRP could be indicated as a treatment for the I and IIA stages of osteonecrosis, as it significantly reduces joint pain and delays THA. This procedure should be avoided in AVNFH related to cortisone therapy because only a few benefits have been proven. It also has the advantage of being technically simple, minimally invasive, and free from complications.",2020,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively.
","['avascular osteonecrosis of femoral head by core decompression and platelet-rich plasma', 'Femoral head osteonecrosis was prospectively evaluated in 30 hips (22 patients, 15-60\xa0years) treated by core decompression and PRP graft', 'Patients presented monolateral or bilateral osteonecrosis in stage I-IIA-IIB according to Arlet and Ficat classification']",['PRP'],"['Harris Hip Score (HHS) and the need for total hip replacement (THA', 'osteonecrosis progression', 'mean preoperative HHS', 'joint pain and delays THA', 'survival rate']","[{'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0353426,"At the five year follow-up, the survival rate was 100% for patients at stage I, 67% for stage IIA, and 0% for stage IIB and was 68% and 32% for idiopathic and secondary osteonecrosis, respectively.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy. marco.grassi7@gmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Salari', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Massetti', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Giuseppe F', 'Initials': 'GF', 'LastName': 'Papalia', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gigante', 'Affiliation': 'Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, via Tronto 10/A, 60126, Torrette di Ancona, Italy.'}]",International orthopaedics,['10.1007/s00264-020-04628-4']
1210,32491239,MRI-Based Radiomics Signature: A Potential Biomarker for Identifying Glypican 3-Positive Hepatocellular Carcinoma.,"BACKGROUND


Glypican 3 (GPC3) expression has proved to be a critical risk factor related to prognosis in hepatocellular carcinoma (HCC) patients.
PURPOSE


To investigate the performance of MRI-based radiomics signature in identifying GPC3-positive HCC.
STUDY TYPE


Retrospective.
POPULATION


An initial cohort of 293 patients with pathologically confirmed HCC was involved in this study, and patients were randomly divided into training (195) and validation (98) cohorts.
FIELD STRENGTH/SEQUENCES


Contrast-enhanced T 1  -weight MRI was performed with a 1.5T scanner.
ASSESSMENT


A total of 853 radiomic features were extracted from the volume imaging. Univariate analysis and Fisher scoring were utilized for feature reduction. Subsequently, forward stepwise feature selection and radiomics signature building were performed based on a support vector machine (SVM). Incorporating independent risk factors, a combined nomogram was developed by multivariable logistic regression modeling.
STATISTICAL TESTS


The predictive performance of the nomogram was calculated using the area under the receive operating characteristic curve (AUC). Decision curve analysis (DCA) was applied to estimate the clinical usefulness.
RESULTS


The radiomics signature consisting of 10 selected features achieved good prediction efficacy (training cohort: AUC = 0.879, validation cohort: AUC = 0.871). Additionally, the combined nomogram integrating independent clinical risk factor α-fetoprotein (AFP) and radiomics signature showed improved calibration and prominent predictive performance with AUCs of 0.926 and 0.914 in the training and validation cohorts, respectively.
DATA CONCLUSION


The proposed MR-based radiomics signature is strongly related to GPC3-positive. The combined nomogram incorporating AFP and radiomics signature may provide an effective tool for noninvasive and individualized prediction of GPC3-positive in patients with HCC. J. MAGN. RESON. IMAGING 2020;52:1679-1687.",2020,"The radiomics signature consisting of 10 selected features achieved good prediction efficacy (training cohort: AUC = 0.879, validation cohort: AUC = 0.871).","['hepatocellular carcinoma (HCC) patients', 'patients with HCC', '293 patients with pathologically confirmed HCC']",['MRI-Based Radiomics Signature'],['clinical risk factor α-fetoprotein (AFP'],"[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}]",293.0,0.0291323,"The radiomics signature consisting of 10 selected features achieved good prediction efficacy (training cohort: AUC = 0.879, validation cohort: AUC = 0.871).","[{'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Wencui', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Zhongyuan', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xubin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China.""}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27199']
1211,32488891,Use of Shear Wave Elastography for Quantitative Assessment of Muscle Stiffness After Botulinum Toxin Injection in Children With Cerebral Palsy.,"OBJECTIVES


This study aimed to investigate the stiffness of the gastrocnemius (GC) muscle with acoustic radiation force impulse (ARFI) elastography after botulinum toxin-A (BTX-A) injection in children with spastic cerebral palsy (CP) and to examine the relationship between elastographic and clinical parameters.
METHODS


This prospective randomized single-blind controlled clinical study included 49 lower extremities of 33 children with spastic CP. They were randomized into 2 groups: group 1 (n = 25 extremities in 17 children) received BTX-A injection and a home-based exercise program; group 2 (n = 24 extremities in 16 children) received only a home-based exercise program. Patients were evaluated in pretreatment and posttreatment periods in the first and third months with ARFI elastography, the Modified Ashworth Scale, Modified Tardieu Scale, Pediatric Functional Independence Measure, Gross Motor Function Classification System, and goniometric range of motion measurement of the ankle.
RESULTS


A statistically significant difference was found in elastography of the GC muscle in group 1 only at the first month after treatment (P < .05). No statistical difference was found in elastography of the GC after treatment in group 2. According to the Modified Ashworth Scale, Modified Tardieu Scale, and ankle passive range of motion, group 1 showed significant improvements after treatment (P < .05). Also, there was a significant correlation between these clinical parameters and elastographic measurements (P < .05).
CONCLUSIONS


According to the results of this study, the measurements from ARFI elastography combined with clinical parameters might be useful for evaluation of spasticity after BTX-A treatment in children with CP. Also, they might be useful in distinguishing patients who will benefit clinically, especially in the early stages of treatment.",2020,A statistically significant difference was found in elastography of the GC muscle in group 1 only at the first month after treatment (P < .05).,"['children with spastic cerebral palsy (CP', '49 lower extremities of 33 children with spastic CP', 'Children With Cerebral Palsy', 'children with CP']","['acoustic radiation force impulse (ARFI) elastography after botulinum toxin-A (BTX-A) injection', 'Botulinum Toxin Injection', 'Shear Wave Elastography', 'BTX-A injection and a home-based exercise program; group 2 (n = 24 extremities in 16 children) received only a home-based exercise program']","['Modified Ashworth Scale, Modified Tardieu Scale, and ankle passive range of motion', 'elastography of the GC muscle', 'Modified Ashworth Scale, Modified Tardieu Scale, Pediatric Functional Independence Measure, Gross Motor Function Classification System, and goniometric range of motion measurement of the ankle', 'clinical parameters and elastographic measurements', 'Muscle Stiffness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1455736', 'cui_str': 'Acoustic radiations structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}]",49.0,0.0174009,A statistically significant difference was found in elastography of the GC muscle in group 1 only at the first month after treatment (P < .05).,"[{'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Bertan', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Julide', 'Initials': 'J', 'LastName': 'Oncu', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ersin', 'Initials': 'E', 'LastName': 'Vanli', 'Affiliation': 'Department of Radiology, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Alptekin', 'Affiliation': 'Bahçeşehir University Institute of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sahillioglu', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kuran', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Yilmaz', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15342']
1212,31805025,Effectiveness of Tailored Rehabilitation Education in Improving the Health Literacy and Health Status of Postoperative Patients With Breast Cancer: A Randomized Controlled Trial.,"BACKGROUND


The improvement of breast cancer treatment and the extension of survivorship have led to the development of postoperative complications among cancer survivors. Health literacy (HL), defined as patients' capability of using health information to maintain their health status, can enable breast cancer patients to manage postoperative complications.
OBJECTIVE


The aims of this study were to develop a tailored rehabilitation education (TRE) program and examine the effectiveness of this program in improving the HL and health status with breast cancer.
METHODS


This randomized controlled trial recruited 99 breast cancer patients (49 and 50 in the intervention and control groups, respectively) within 1 week after surgery. Four-week individualized TRE programs were implemented to improve their HL and health status.
RESULTS


Our results showed that the TRE program produced significant improvements in HL and health status in the components of the International Classification of Functioning, Disability and Health. However, no significant difference was observed in the activity scores obtained using the Barthel Index between the 2 groups.
CONCLUSION


Our finding supports the effectiveness of 1-month TRE in improving HL and all components of the International Classification of Functioning, Disability and Health status, except the activity component among breast cancer in Taiwan.
IMPLICATIONS FOR PRACTICE


Clinicians could incorporate the TRE techniques in the rehabilitation sessions according to the healthcare, disease prevention, and health promotion domains to improve the clinical outcomes as well as change their health behaviors and attitudes of patients with breast cancer.",2020,"However, no significant difference was observed in the activity scores obtained using the Barthel Index between the 2 groups.
","['Postoperative Patients With Breast Cancer', '99 breast cancer patients (49 and 50 in the intervention and control groups, respectively) within 1 week after surgery', 'breast cancer in Taiwan', 'patients with breast cancer']","['Tailored Rehabilitation Education', 'TRE', 'tailored rehabilitation education (TRE) program', 'TRE program']","['HL and health status', 'activity scores', 'Health Literacy and Health Status']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.0172838,"However, no significant difference was observed in the activity scores obtained using the Barthel Index between the 2 groups.
","[{'ForeName': 'Szu-Chi', 'Initials': 'SC', 'LastName': 'Huang', 'Affiliation': 'Author Affiliations: Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital (Ms Huang and Drs CY Lin and Hou); School of Nursing, College of Nursing, Taipei Medical University (Drs Kuo, Tsai, and PC Lin); Department of Physical Medicine and Rehabilitation, E-Da Cancer Hospital/I-Shou University, Kaohsiung (Ms Tsai); Department of Physical Medicine and Rehabilitation, E-Da Hospital/I-Shou University, Kaohsiung (Mr Chen); Department of Nursing, Wang Fang Hospital, Taipei Medical University (Dr Tsai); Master Program in Long-term Care, College of Nursing, Taipei Medical University (Ms Huang and Drs PC Lin and Hou); School of Gerontology Health Management, College of Nursing, Taipei Medical University (Dr Hou); and Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taiwan (Dr Hou).'}, {'ForeName': 'Shu-Fen', 'Initials': 'SF', 'LastName': 'Kuo', 'Affiliation': ''}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Chia-Yin', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Sheng-Shiung', 'Initials': 'SS', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Chia-Yun', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Pi-Chu', 'Initials': 'PC', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Wen-Hsuan', 'Initials': 'WH', 'LastName': 'Hou', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000665']
1213,32588134,"Norepinephrine prophylaxis for postspinal anesthesia hypotension in parturient undergoing cesarean section: a randomized, controlled trial.","OBJECTIVE


To investigate the efficacy and safety of prophylactic infusion of norepinephrine (NE) versus normal saline in patients undergoing cesarean section.
METHODS


Patients (n = 97) were randomized to receive a bolus of NE (6 μg) immediately following spinal anesthesia with maintenance NE (0.05 μg/kg/min IV) or normal saline (n = 98). The primary endpoint was the incidence of postspinal anesthesia hypotension [systolic blood pressure (SBP) < 80% of baseline] at 1-20 min following spinal anesthesia. Secondary outcomes were the overall stability of SBP control versus baseline, inferior vena cava collapsibility index (IVC-CI), other adverse events (bradycardia, nausea, vomiting, and hypertension), and neonatal outcomes (blood gas values and Apgar scores).
RESULTS


The rates of postspinal anesthesia hypotension and severe postspinal anesthesia hypotension (SBP < 60% of the baseline) were significantly lower in the NE group (17.5% vs. 62.2%, p < 0.001; 7.2% vs. 17.4%, p = 0.031). In the NE group, SBP remained more stable and closer to baseline (p < 0.001), and IVC-CI values were lower 5 min after spinal anesthesia and 5 min after fetal delivery (p = 0.045; p < 0.001, respectively). Other adverse effects and neonatal outcomes were not different between the two groups.
CONCLUSION


Prophylactic NE infusion effectively lowers the incidence of postspinal anesthesia hypotension and does not increase other adverse events in patients or neonates.",2020,Prophylactic NE infusion effectively lowers the incidence of postspinal anesthesia hypotension and does not increase other adverse events in patients or neonates.,"['patients or neonates', 'Patients (n\u2009=\u200997', 'patients undergoing cesarean section', 'parturient undergoing cesarean section']","['normal saline', 'spinal anesthesia with maintenance NE', 'norepinephrine (NE', 'Norepinephrine prophylaxis', 'Prophylactic NE', 'NE']","['rates of postspinal anesthesia hypotension and severe postspinal anesthesia hypotension', 'IVC-CI values', 'overall stability of SBP control versus baseline, inferior vena cava collapsibility index (IVC-CI), other adverse events (bradycardia, nausea, vomiting, and hypertension), and neonatal outcomes (blood gas values and Apgar scores', 'incidence of postspinal anesthesia hypotension [systolic blood pressure (SBP', 'adverse events', 'incidence of postspinal anesthesia hypotension', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.354647,Prophylactic NE infusion effectively lowers the incidence of postspinal anesthesia hypotension and does not increase other adverse events in patients or neonates.,"[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics, General Hospital of Ningxia Medical University, Yinchuan, 750004, Ningxia, China.'}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology, General Hospital of Ningxia Medical University, 804S Shengli Street, Yinchuan, 750004, Ningxia, China. xinlini6@nyfy.com.cn.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05663-7']
1214,32589339,Feasibility of FitSurvivor: A technology-enhanced group-based fitness intervention for adolescent and young adult survivors of childhood cancer.,"BACKGROUND


This study evaluated the feasibility of a technology-enhanced group-based fitness intervention for adolescent and young adult (AYA) survivors of childhood cancer.
PROCEDURE


AYA survivors ages 13-25 years were randomized to the intervention (eight in-person group sessions with mobile app and FitBit followed by 4 weeks of app and FitBit only) or waitlist control. Assessments were at 0, 2, 3, 6, and 9 months. Feasibility was evaluated by enrollment, retention, attendance, app engagement, and satisfaction. Secondary outcomes included physical activity, muscular strength/endurance, cardiorespiratory fitness, health-related quality of life, and fatigue.
RESULTS


A total of 354 survivors were mailed participation letters; 68 (19%) were screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible). Forty-nine survivors (M age   = 18.5 years, 49% female) completed baseline assessments and were randomized (25 intervention, 24 waitlist). Thirty-seven (76%) completed the postintervention assessment and 32 (65%) completed the final assessment. On average, participants attended 5.7 of eight sessions (range 1-8). Overall intervention satisfaction was high (M = 4.3, SD = 0.58 on 1-5 scale). Satisfaction with the companion app was moderately high (M = 3.4, SD = 0.97). The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures.
CONCLUSIONS


A group-based intervention with a mobile app and fitness tracker was acceptable but has limited reach due to geographical barriers and competing demands experienced by AYA survivors.",2020,"The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures.
","['Forty-nine survivors (M age  \xa0', 'adolescent and young adult (AYA) survivors of childhood cancer', 'AYA survivors ages 13-25\xa0years', 'adolescent and young adult survivors of childhood cancer', 'A total of 354 survivors were mailed participation letters; 68 (19%) were screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible']","['FitSurvivor', 'intervention (eight in-person group sessions with mobile app and FitBit followed by 4\xa0weeks of app and FitBit only) or waitlist control', 'technology-enhanced group-based fitness intervention']","['Overall intervention satisfaction', 'physical activity, muscular strength/endurance, cardiorespiratory fitness, health-related quality of life, and fatigue', 'lower body muscle strength', 'retention, attendance, app engagement, and satisfaction', 'Satisfaction']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439175', 'cui_str': '% of total'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",354.0,0.0427851,"The intervention group demonstrated significantly greater improvement in lower body muscle strength compared to the waitlist postintervention, and small but not statistically significant changes in other secondary measures.
","[{'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Devine', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Viola', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Levonyan-Radloff', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Mackowski', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bozzini', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Chandler', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Baichen', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ohman-Strickland', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Mayans', 'Affiliation': 'Hackensack Meridian Health, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Farrar-Anton', 'Affiliation': 'Hackensack Meridian Health, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Olle Jane Z', 'Initials': 'OJZ', 'LastName': 'Sahler', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Masterson', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Manne', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Arent', 'Affiliation': 'Rutgers, The State University of New Jersey, New Brunswick, New Jersey.'}]",Pediatric blood & cancer,['10.1002/pbc.28530']
1215,32590831,Long-Axis In-Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"OBJECTIVES


The aim of this study was to compare the occurrence of posterior wall puncture between the long-axis in-plane and the short-axis out-of-plane approaches in a randomized controlled trial of pediatric patients who underwent cardiovascular surgery under general anesthesia.
DESIGN


Prospective randomized controlled trial.
SETTING


Operating room of Osaka Women's and Children's Hospital.
PATIENTS


Pediatric patients less than 5 years old who underwent cardiovascular surgery.
INTERVENTIONS


Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach.
MEASUREMENTS AND MAIN RESULTS


The occurrence of posterior wall puncture was compared between the long-axis in-plane and short-axis out-of-plane approaches for ultrasound-guided central venous catheterization. Patients were randomly allocated to a long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group). After exclusion, 97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups. Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003). First attempt success rates were 67.3% (33/49) and 64.6% (31/48) in the long-axis and short-axis groups, respectively (relative risk, 1.04; 95% CI, 0.78-1.39; p = 0.77). Overall success rates within 20 minutes were 93.9% (46/49) and 93.8% (45/48) in the long-axis and short-axis groups, respectively (relative risk, 0.99; 95% CI, 0.90-1.11; p = 0.98).
CONCLUSIONS


The long-axis in-plane approach for ultrasound-guided central venous catheterization is a useful technique for avoiding posterior wall puncture in pediatric patients, compared with the short-axis out-of-plane approach.",2020,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","['97 patients were allocated to the long-axis (n = 49) or short-axis (n = 48) groups', ""Operating room of Osaka Women's and Children's Hospital"", 'pediatric patients', 'Pediatric Patients', 'pediatric patients who underwent cardiovascular surgery under general anesthesia', 'Pediatric patients less than 5 years old who underwent cardiovascular surgery']","['long-axis group or a short-axis group and underwent ultrasound-guided central venous catheterization in the internal jugular vein using either the long-axis in-plane approach (long-axis group) or the short-axis out-of-plane approach (short-axis group', 'Plane Approach Versus Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheterization', 'Ultrasound-guided central venous catheterization using the long-axis in-plane approach and short-axis out-of-plane approach', 'ultrasound-guided central venous catheterization']","['occurrence of posterior wall puncture', 'success rates', 'Overall success rates', 'Posterior wall puncture rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007435', 'cui_str': 'Central venous catheterisation'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",97.0,0.0729776,"Posterior wall puncture rates were 8.2% (4/49) and 39.6% (19/48) in the long-axis and short-axis groups, respectively (relative risk, 0.21; 95% CI, 0.076-0.56; p = 0.0003).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Tachibana', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Nakajima', 'Affiliation': 'Department of Anesthesiology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Nagai', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Fujiwara', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hamaba', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Matsuura', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': ""Department of Anesthesiology, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan.""}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Institute of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002476']
1216,32591862,A randomized controlled phase II clinical trial on mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL) as adjuvant treatment for stage III/IV melanoma patients who are disease-free following the resection of macrometastases.,"BACKGROUND


Autologous monocyte-derived mRNA co-electroporated dendritic cells with mRNA encoding CD40 ligand (CD40L), CD70 and a constitutively activated TLR4 (caTLR4) (referred to as TriMixDC-MEL) have anti-tumor activity in advanced melanoma patients. We investigated the safety and activity of adjuvant TriMixDC-MEL in stage III/IV melanoma patients.
MATERIALS AND METHODS


Forty-one patients were randomly assigned to treatment with TriMixDC-MEL (n = 21) and standard follow-up (n = 20). ""Cross-over"" was allowed at the time of non-salvageable recurrence. The primary endpoint was the percentage of patients alive and disease-free at 1-year. For a subset of patients, (formalin-fixed paraffin-embedded), tumor tissue samples were available for mRNA expression profiling and PD-L1 immunohistochemical staining.
RESULTS


Baseline characteristics were well balanced. One-year after randomization, 71% of patients in the study arm were alive and free of disease compared to 35% in the control arm. After a median follow-up of 53 months (range 3-67), 23 patients experienced a non-salvageable melanoma recurrence (TriMixDC-Mel arm n = 9 and control arm n = 14).The median time to non-salvageable recurrence was superior in the TriMixDC-MEL arm (median 8 months (range 1-6) vs. not reached; log-rank p 0.044). TriMixDC-MEL-related adverse events (AE) consisted of transient local skin reactions, flu-like symptoms and post-infusion chills. No grade ≥ 3 AE's occurred. The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers.
CONCLUSION


TriMixDC-MEL id/iv as adjuvant therapy is tolerable and may improve the 1-year disease-free survival rate. Combination of optimized autologous monocyte-derived DC-formulations warrants further investigation in combination with currently approved adjuvant therapy options.",2020,"The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers.
","['stage III/IV melanoma patients', 'advanced melanoma patients', 'Forty-one patients', 'stage III/IV melanoma patients who are disease-free following the resection of macrometastases']","['adjuvant TriMixDC-MEL', 'mRNA electroporated autologous monocyte-derived dendritic cells (TriMixDC-MEL', 'TriMixDC-MEL']","['median time to non-salvageable recurrence', 'non-salvageable melanoma recurrence', '1-year disease-free survival rate', 'alive and free of disease', 'percentage of patients alive and disease-free at 1-year']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0939937', 'cui_str': 'Honey preparation'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",41.0,0.316794,"The mRNA expression profiling revealed four genes (STAT2, TPSAB1, CD9 and CSF2) as potential predictive biomarkers.
","[{'ForeName': 'Yanina', 'Initials': 'Y', 'LastName': 'Jansen', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium. Yanina.jansen@uzbrussel.be.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Kruse', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Corthals', 'Affiliation': 'Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schats', 'Affiliation': 'Histogenex NV, Antwerp, Belgium.'}, {'ForeName': 'Pieter-Jan', 'Initials': 'PJ', 'LastName': 'van Dam', 'Affiliation': 'Histogenex NV, Antwerp, Belgium.'}, {'ForeName': 'Teofila', 'Initials': 'T', 'LastName': 'Seremet', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Heirman', 'Affiliation': 'Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Brochez', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Gent (UZ Gent), Ghent, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kockx', 'Affiliation': 'Histogenex NV, Antwerp, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Thielemans', 'Affiliation': 'Laboratory of Molecular and Cellular Therapy and Dendritic Cell-bank, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Department of Medical Oncology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 103, 1090, Brussels, Belgium.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-020-02618-4']
1217,31834239,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND


ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS


Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS


The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS


There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE


Level I.",2019,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
1218,32602170,Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial.,"It is unclear if genetic variants affect smoking cessation treatment response. This study tested whether variants in the cholinergic receptor nicotinic alpha 5 subunit (CHRNA5) predict response to smoking cessation medication by directly comparing the two most effective smoking cessation pharmacotherapies. In this genotype-stratified randomized, double-blind, placebo-controlled clinical trial (May 2015-August 2019 in St Louis, Missouri), smokers were randomized by genotype in blocks of six (1:1:1 ratio) to three conditions: 12 weeks of placebo (n = 273), combination nicotine patch and lozenge (combination nicotine replacement therapy, cNRT, n = 275), or varenicline (n = 274). All participants received counseling and were followed for 12 months. The primary end point was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT, week 12). Trial registration and eligibility criteria are on clinicaltrials.gov (https://clinicaltrials.gov/) (NCT02351167). We conducted the genetic analyses separately for 516 European ancestry (EA) smokers and 306 non-EA smokers (including 270 African American smokers). In African American smokers, there was a genotype-by-treatment interaction for EOT abstinence (χ 2   = 10.7, degrees of freedom = 2. P = 0.0049): specifically, cNRT was more effective in smokers with rs16969968 GG genotype than was placebo, while varenicline was more effective in smokers of GA/AA genotypes. In EA ancestry smokers, there was no significant genotype-by-treatment interaction. In the whole sample, although both were effective at EOT, only varenicline, and not cNRT, was significantly effective relative to placebo at 6-month follow-up. Importantly, this study suggests that genetic information can further enhance smoking cessation treatment effectiveness.",2020,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","['African American smokers', '516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers']","['varenicline, and not cNRT', 'placebo', 'cholinergic receptor nicotinic alpha 5 subunit (CHRNA5', 'Varenicline and Combination Nicotine Replacement', 'varenicline', 'combination nicotine patch and lozenge (cNRT, n=275), or varenicline', 'cNRT']",['7-day point prevalence abstinence'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.197091,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Smock', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Jingling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Stoneking', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1971']
1219,32603531,Febuxostat therapy in outpatients with suspected COVID-19: A clinical trial.,"BACKGROUND


The aim of this clinical trial was to evaluate the effects of febuxostat (FBX) in comparison with hydroxychloroquine (HCQ) on clinical symptoms, laboratory tests and chest CT findings in outpatients with moderate symptoms of COVID-19 infection.
METHODS


We conducted a clinical trial involving adult outpatients with the moderate respiratory illness following COVID-19 infection. Patients were randomly assigned to receive either FBX or HCQ for 5 days. The measured variables were needs to hospitalisation, clinical and laboratory data including fever, cough, breathing rate, C-Reactive Protein level, lymphocytes count at onset of admission and was well as at 5 days of treatments. In addition, CT findings were evaluated on admission and 14 days after initiation of treatment.
RESULTS


Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups. On admission, fever (66.7%), cough (87%), tachypnoea (44.4%), dyspnoea (35%), elevated CRP value (94.4%) and lung involvement according to chest CT (100%) were documented in enrolled patients with insignificant difference between FBX and HCQ groups. Fever, cough and tachypnoea were significantly mitigated in both groups after five days of treatments without any significant differences between groups. The mean percentages of lung involvement were significantly reduced to 7.3% and 8% after 14 days of treatment with FBX and HCQ, respectively. In adult outpatients with moderate COVID-19 infection, the effectiveness of FBX and HCQ was not different in terms of resolution of clinical manifestations, laboratory tests and lung CT findings.
CONCLUSION


This trial suggests that FBX is as an alternative treatment to HCQ for COVID-19 infection and may be considered in patients with a contraindication or precaution to HCQ.",2020,"Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups.","['Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups', 'outpatients with suspected COVID-19', 'patients with a contraindication or precaution to HCQ', 'adult outpatients with the moderate respiratory illness following COVID-19 infection', 'adult outpatients with moderate COVID-19 infection', 'outpatients with moderate symptoms of COVID-19 infection']","['Febuxostat therapy', 'FBX', 'hydroxychloroquine (HCQ', 'FBX or HCQ', 'febuxostat (FBX']","['hospitalization, clinical and laboratory data including fever, cough, breathing rate, C-Reactive Protein level, lymphocytes count at onset of admission', 'mean percentages of lung involvement', 'cough', 'Fever, cough and tachypnea', 'dyspnea', 'tachypnea', 'elevated CRP value']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0984218,"Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups.","[{'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoodi', 'Affiliation': 'Department of Infection Diseases, Antimicrobial Resistance Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Abedi', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh-Navaei', 'Affiliation': 'Gastrointestinal Cancer Research Center, Non-communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Rouhanizadeh', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ghasemali', 'Initials': 'G', 'LastName': 'Khorasani', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hosseinimehr', 'Affiliation': 'Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",International journal of clinical practice,['10.1111/ijcp.13600']
1220,32583907,Randomised clinical trial: minesapride vs placebo for irritable bowel syndrome with predominant constipation.,"BACKGROUND


Agonists of 5-hydroxytryptamine 4 receptor are potential agents for irritable bowel syndrome with predominant constipation (IBS-C). However, only tegaserod has been approved for a very limited population in the US.
AIM


To evaluate the efficacy and safety of minesapride in patients with Rome IV defined IBS-C.
METHODS


A double-blind, placebo-controlled, dose-finding study was performed. Overall, 411 patients were randomised to receive minesapride at 10, 20 or 40 mg/d, or placebo for 12 weeks. The primary endpoint was Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements from baseline and improvement of ≥30% from baseline in weekly average of worst abdominal pain score, both in the same week for ≥6/12 weeks).
RESULTS


The FDA composite responder rate was 13.6% (14/103) in the placebo group, 13.6% (14/103) in the 10 mg group, 19.2% (20/104) in the 20 mg group and 14.9% (15/101) in the 40 mg group, and no dose-response relationship was found. A greater percentage of minesapride 40 mg-treated patients than placebo-treated patients met both responder requirements for ≥9/12 weeks as the stricter composite evaluation (P < 0.05). Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12). The most common adverse event was mild diarrhoea.
CONCLUSIONS


Minesapride was safe and well-tolerated. Although the primary endpoint was negative, minesapride 40 mg is likely to improve the stricter composite endpoint and SBM frequency. Japan Pharmaceutical Information Center Number: Japic CTI-163459.",2020,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","['irritable bowel syndrome with predominant constipation (IBS-C', 'patients with Rome IV defined IBS-C', 'irritable bowel syndrome with predominant constipation', '411 patients']","['5-hydroxytryptamine', 'minesapride vs placebo', 'minesapride', 'placebo']","['stricter composite endpoint and SBM frequency', 'SBM frequency', 'Food and Drug Administration (FDA) composite endpoint (responder: a patient who reported an increase in one or more complete spontaneous bowel movements', 'efficacy and safety', 'safe and well-tolerated', 'worst abdominal pain score', 'FDA composite responder rate']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",411.0,0.467554,"Furthermore, minesapride 40 mg significantly increased SBM frequency compared with placebo (adjusted P < 0.001 at Week 12).","[{'ForeName': 'Tatsuto', 'Initials': 'T', 'LastName': 'Hamatani', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Fukudo', 'Affiliation': 'Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Nakada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Inada', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kiyoyasu', 'Initials': 'K', 'LastName': 'Kazumori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15907']
1221,32585668,Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial.,"OBJECTIVE


To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial.
DESIGN


Randomized, multicenter, 2 group, open-label clinical trial.
SETTING


A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany.
PATIENTS


A total of 1,000 patients underwent randomization from May 2011 till September 2015.
INTERVENTIONS


We analyzed the effect of intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator.
MEASUREMENTS AND MAIN RESULTS


Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9 ± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55-0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9-1.2).
CONCLUSIONS


Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.",2020,"The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator.
","['patients with moderate to severe grade ICH', 'patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial', 'A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany', 'Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage', 'A total of 1,000 patients underwent randomization from May 2011 till September 2015', 'moderate to severe grade subjects with ICH in a non-prespecified analysis']","['intensive blood pressure reduction', 'nicardipine']","['frequency of hematoma expansion', 'Glasgow Coma Scale score', 'systolic blood pressure (SBP) reduction', 'rate of death or disability', 'standard SBP reduction', 'intensive SBP reduction', 'death or disability (score 4-6 on the modified Rankin scale', 'death or disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",1000.0,0.292665,"The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator.
","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA, qureshai@gmail.com.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Neurosciences Critical Care, Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine Baltimore, Baltimore, Maryland, USA.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506358']
1222,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND


Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions.
METHODS


A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed.
RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position.
CONCLUSIONS


When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS


Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151']
1223,32591475,"Natalizumab in acute ischemic stroke (ACTION II): A randomized, placebo-controlled trial.","OBJECTIVE


We evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).
METHODS


In this double-blind phase 2b trial, patients with AIS aged 18-80 years with NIH Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model;  p  values were not used for hypothesis testing.
RESULTS


An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).
CONCLUSIONS


Natalizumab administered ≤24 hours after AIS did not improve patient outcomes.
CLINICALTRIALSGOV IDENTIFIER


NCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.",2020,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"['patients with AIS', 'acute ischemic stroke (AIS) patients', 'AIS patients aged 18-80 years with National Institutes of Health Stroke Scale scores of 5-23 from 53 US and European sites']","['Natalizumab', 'placebo (natalizumab', 'natalizumab or placebo, with randomization stratified by treatment window ', 'natalizumab', 'placebo']","['serious adverse events', 'deaths', 'patient outcomes', 'composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.783971,An excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 mg or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93).,"[{'ForeName': 'Mitchell S V', 'Initials': 'MSV', 'LastName': 'Elkind', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA. mse13@columbia.edu.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Veltkamp', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Montaner', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Aneesh B', 'Initials': 'AB', 'LastName': 'Singhal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Kasliwal', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Elkins', 'Affiliation': ""From Columbia University (M.S.V.E.), New York, NY; Imperial College London (R.V.), UK; Alfried-Krupp Krankenhaus (R.V.), Essen, Germany; Vall d'Hebron Research Institute (VHIR) (J.M.), Barcelona; Institute of Biomedicine of Seville (IBiS) Stroke Programme (J.M.), Spain; University of Texas (S.C.J.), Austin; Massachusetts General Hospital (A.B.S.), Boston; University of Washington (K.B.), Seattle; Stanford University Medical Center (M.G.L.), Stanford Stroke Center, CA; and Biogen (W.T., R.K., J.E.), Cambridge, MA.""}]",Neurology,['10.1212/WNL.0000000000010038']
1224,32608933,Rotational flywheel training in youth female team sport athletes: could inter-repetition movement variability be beneficial?,"BACKGROUND


The aim of this study was to analyze the effects of an inter-repetition variable rotational flywheel training program (variable) over standard rotational flywheel training (Standard).
METHODS


Twenty-four youth female team-sports players were randomly assigned to both training groups (variable, N.=12; standard, N.=12), which consisted of 1 set of 3 rotational flywheel exercises ×10-12 repetitions, biweekly for a period of 6-weeks. The participants included in variable group were instructed to perform the movement randomly in one of the three directions (0°, 45° right, and 45° left). Measurements included reactive strength, jumping, change of direction, and sprinting tests; patellar tendon condition was also assessed.
RESULTS


Substantial improvements were found in vertical jump with left leg (16.9%), lateral jump with right leg (13.6%), and patellar condition in left leg (4.1%) for standard group, but also in reactive strength index in right leg landing (33.9%), vertical jump with right (10.1%) and left leg (12.0%) for variable group. A significant interaction effect (group × time) was observed on patellar condition in right leg (F=10.02, P<0.01, η<sup>2</sup>=0.37), favoring variable group.
CONCLUSIONS


Rotational flywheel training programs were beneficial for youth-female team-sports athletes, although the movement variability may play a key role to develop different and specific physical adaptations.",2020,"RESULTS


Substantial improvements were found in vertical jump with left leg (16.9%), lateral jump with right leg (13.6%), and patellar condition in left leg (4.1%) for Standard group, but also in reactive strength index in right leg landing (33.9%), vertical jump with right (10.1%) and left leg (12.0%) for Variable group.","['youth female team sport athletes', 'youth-female team-sports athletes', 'Twenty-four youth female team-sports players']","['inter-repetition variable rotational flywheel training program (Variable) over standard rotational flywheel training (Standard', 'Rotational flywheel training programs', 'Rotational flywheel training']","['reactive strength index in right leg landing', 'left leg', 'lateral jump with right leg', 'patellar condition in left leg', 'patellar condition in right leg', 'reactive strength, jumping, change of direction, and sprinting tests; patellar tendon condition', 'vertical jump with left leg']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230443', 'cui_str': 'Structure of left lower leg'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",24.0,0.0207872,"RESULTS


Substantial improvements were found in vertical jump with left leg (16.9%), lateral jump with right leg (13.6%), and patellar condition in left leg (4.1%) for Standard group, but also in reactive strength index in right leg landing (33.9%), vertical jump with right (10.1%) and left leg (12.0%) for Variable group.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arede', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, Vila Real, Portugal - jorge_arede@hotmail.com.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Faculty of Health Sciences, University of San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'Wolfgang I', 'Initials': 'WI', 'LastName': 'Schöllhorn', 'Affiliation': 'Institute of Sports Science, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10962-9']
1225,32608934,Effects of resistance training combined with ischemic preconditioning on muscle size and strength in resistance-trained individuals.,"BACKGROUND


The present study investigated the effects of resistance training combined with ischemic preconditioning (IPC) on muscle size and strength in resistance-trained men.
METHODS


Sixteen resistance-trained men were divided into two groups (Placebo and IPC) and trained twice a week for 6 weeks. Preconditioning protocols consisted of four, 5-min cycling bouts of ischemia/Placebo (250 or 10 mmHg, respectively) interspersed with 5 min of reperfusion (without pressure) alternated in each leg. Thirty minutes after the preconditioning protocol, participants performed 4 sets to concentric failure at 75% of one repetition-maximum (1-RM) in unilateral knee extension exercise. Muscle thickness (ultrasound) and 1RM were assessed at baseline and 72 hours after the last training session. ANCOVA was used to compare muscle thickness and 1RM changes, using muscle thickness and 1-RM baseline values, respectively, as covariates. Significance level was set at P<0.05.
RESULTS


Average of number of repetitions was higher in IPC compared to Placebo (13±4 and 11±2, respectively; P=0.0002). Muscle thickness did not change in either group from pre- to post-6 weeks (P=0.32). IPC improved 1-RM more than Placebo (P=0.04).
CONCLUSIONS


IPC may augment greater strength gains in resistance-trained men due to an increase in training volume.",2020,"IPC improved 1-RM more than Placebo (p = 0.04).
","['resistance-trained men', 'resistance-trained individuals', 'Sixteen resistance-trained men']","['Placebo', 'resistance training combined with ischemic preconditioning (IPC', 'resistance training combined with ischemic preconditioning', 'repetition-maximum (1-RM) in unilateral knee extension exercise', 'Placebo and IPC', 'ischemia/placebo']","['strength gains', 'Muscle thickness', 'number of repetitions', 'muscle thickness and 1RM changes, using muscle thickness and 1-RM baseline values', 'IPC improved 1-RM', 'muscle size and strength', 'Muscle thickness (ultrasound) and 1RM']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.116078,"IPC improved 1-RM more than Placebo (p = 0.04).
","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Carvalho', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Concon', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Eduardo O', 'Initials': 'EO', 'LastName': 'De Souza', 'Affiliation': 'Department of Health Sciences and Human Performance, University of Tampa, Tampa, FL, USA.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Barroso', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil - rbarroso@unicamp.br.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11032-6']
1226,32606635,Evaluation of Pectoral Nerve Block in Modified Radical Mastectomy: Comparison of Three Concentrations of Ropivacaine.,"Background


Pectoral nerve block type I (PECS I Block) and type II (PECS II Block) with ropivacaine are relatively new analgesic methods for breast-cancer surgery. We evaluated the safety and efficacy of different concentrations of ropivacaine given in the same volume for the PECS II Block in patients undergoing modified radical mastectomy (MRM).
Patients and Methods


One hundred and twenty women undergoing elective MRM who met inclusion criteria were divided randomly into four groups of 30: control group without PECS II Block and R 0.2% , R 0.3% , and R 0.4%  groups, who received general anesthesia plus the PECS II Block with ropivacaine at 0.2%, 0.3%, and 0.4%, respectively, in a volume of 40 mL.
Results


The postoperative numerical rating scale (NRS) pain score at rest and active was significantly higher in the control group than that in the three ropivacaine groups (P<0.05 for all), and the postoperative NRS score in the R 0.3%  group and R 0.4%  group at 12, 24, and 48 h postoperatively were significantly lower than that in the R 0.2%  group (P<0.05 for all); there was no significant difference between the R 0.3%  group and R 0.4%  group. The time when pain was first felt after MRM, the total number of complaints during 3, 6, 12, 24, and 48 h after MRM, and the total analgesic requirement (tramadol consumption) during the first 24 h postoperatively in the R 0.3%  group and R 0.4%  group were significantly lower than those in the control group and R 0.2%  group (P<0.05 for all); there was no significant difference between the R 0.3%  group and R 0.4%  group.
Conclusion


A dose of 0.3% ropivacaine was the optimal concentration for a PECS II Block for patients undergoing MRM because it provided efficacious analgesia during and >48 h after MRM. Increasing the ropivacaine concentration did not improve the analgesia of the PECS II Block significantly.",2020,Increasing the ropivacaine concentration did not improve the analgesia of the PECS II Block significantly.,"['Patients and Methods\n\n\nOne hundred and twenty women undergoing elective MRM who met inclusion criteria', 'breast-cancer surgery', 'patients undergoing modified radical mastectomy (MRM']","['Modified Radical Mastectomy', 'Pectoral Nerve Block', 'ropivacaine', 'control group without PECS II Block', 'PECS', 'general anesthesia plus the PECS II Block with ropivacaine', 'Ropivacaine', '\n\n\nPectoral nerve block type']","['total analgesic requirement (tramadol consumption', 'postoperative numerical rating scale (NRS) pain score at rest and active', 'total number of complaints', 'safety and efficacy', 'postoperative NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4273496', 'cui_str': 'PECS II block'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0495057,Increasing the ropivacaine concentration did not improve the analgesia of the PECS II Block significantly.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ""Department of Anesthesiology, The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), Jiaxing, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Fu', 'Affiliation': ""Department of Paediatrics, Affiliated Hospital of Guilin Medical University, Guilin, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Guilin Medical University, Guilin, People's Republic of China.""}]",Clinical interventions in aging,['10.2147/CIA.S251613']
1227,31825020,Three-Month Effect of Silver Diamine Fluoride (SDF) in Salivary Levels of Streptococcus Mutans in Children. An Exploratory Trial.,"PURPOSE


The aim of this exploratory trial was to compare the 3-month effect of two antimicrobials on the salivary levels of Streptococcus mutans (SM) in children.
MATERIALS AND METHODS


Ninety school children aged 6-10 years participated. They were divided into two groups according to treatment used: 1% chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF). Saliva for SM colony forming unit (CFU)/ml counting was harvested in four periods: baseline (prior to antimicrobials); P1 (24 h after antimicrobial therapy); P30 (30 days after antimicrobial therapy); and P90 (90 days after antimicrobial therapy). CFU/ml data was submitted to repeated measures by analysis of variance (ANOVA).
RESULTS


Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline. No influence of antimicrobials or interactions of factors were detected (p >0.05). P30 presented the lowest levels of SM and at P90, SM levels were similar to P1 but still lower than the baseline observations. SDF and CHX presented a similar effect on SM within each period of evaluation (p = 0.65).
CONCLUSION


It was concluded that 30% SDF presents similar antimicrobial effects as 1% CHX over time. SDF might be used as an adjunctive therapy for controlling dental caries in children.",2020,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","['Ninety school children aged 6-10 years participated', 'Salivary Levels of Streptococcus Mutans in Children', 'children']","['Silver Diamine Fluoride (SDF', 'chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF']","['lowest levels of SM and at P90, SM levels', 'antimicrobial effects', 'salivary levels of Streptococcus mutans (SM']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0108801', 'cui_str': 'TFRC protein, human'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",90.0,0.0577897,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","[{'ForeName': 'Marta Diogo', 'Initials': 'MD', 'LastName': 'Garrastazu', 'Affiliation': ''}, {'ForeName': 'Ingrid Fernandes', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': ''}, {'ForeName': 'Rafael Santos', 'Initials': 'RS', 'LastName': 'Rocha', 'Affiliation': ''}, {'ForeName': 'Michele Baffi', 'Initials': 'MB', 'LastName': 'Diniz', 'Affiliation': ''}, {'ForeName': 'Taciana Marco Ferraz', 'Initials': 'TMF', 'LastName': 'Caneppele', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43360']
1228,32610487,A Three-Arm Randomised Controlled Trial of High- and Low-Intensity Implementation Strategies to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines: 12-Month Follow-Up.,"The study aimed to compare the effectiveness of a suite of implementation strategies of varying intensities on centre-based childcare service implementation of nutrition guideline recommendations at 12-month follow-up. A six-month three-arm parallel group randomised controlled trial was undertaken with 69 services, randomised to one of three arms: high-intensity strategies (executive support; group face-to-face training; provision of resources; multiple rounds of audit and feedback; ongoing face-to-face and phone support); low-intensity strategies (group face-to-face training; provision of resources; single round of audit and feedback); or usual care control. Across all study arms, only three high-intensity services were compliant with overall nutrition guidelines. A significant group interaction was found between the three arms for compliance with individual food groups. Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods. No significant differences between the high- and low-intensity for individual food group compliance were found. High-intensity implementation strategies may be effective in supporting childcare service implementation of individual food group recommendations. Further research is warranted to identify strategies effective in increasing overall nutrition compliance.",2020,"Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods.",['to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines'],"['high-intensity strategies (executive support; group face-to-face training; provision of resources; multiple rounds of audit and feedback; ongoing face-to-face and phone support); low-intensity strategies (group face-to-face training; provision of resources; single round of audit and feedback); or usual care control', 'High- and Low-Intensity Implementation Strategies']",[],"[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],,0.0519355,"Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Seward', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Local Health District, Population Health, Wallsend 2287, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17134664']
1229,32479794,"Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.","BACKGROUND


We evaluated the efficacy and safety of tepotinib, a potent and highly selective oral MET inhibitor, plus gefitinib in patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition.
METHODS


In this open-label, phase 1b/2, multicentre, randomised trial (the INSIGHT study), we enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries. In phase 1b, patients received oral tepotinib 300 mg or 500 mg plus gefitinib 250 mg once daily. In phase 2, patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification were randomly assigned (initially in a 1:1 ratio and then 2:1 following a protocol amendment) to tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy. Randomisation was done centrally via an interactive voice-response system. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. Subgroup analyses were preplanned in patients with high MET overexpression (IHC3+) or MET amplification (mean gene copy number ≥5 or MET to centromere of chromosome 7 ratio ≥2). Efficacy and patient characteristics were assessed on an intention-to-treat basis and safety was assessed for all patients who received at least one dose of study medication. Low recruitment led to early termination of phase 2, so all analyses are considered to be exploratory. This study is registered with ClinicalTrials.gov, NCT01982955, and the European Union Drug Regulating Authorities Clinical Trials Database, Eudra-CT 2016-001604-28.
FINDINGS


From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group; n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group; n=24 in the chemotherapy group). No dose-limiting toxicities were observed in phase 1b, so tepotinib 500 mg was used as the recommended phase 2 dose. In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio [HR] 0·67, 90% CI 0·35-1·28). Median OS was 17·3 months in the tepotinib plus gefitinib group (12·1-37·3) versus 18·7 months in the chemotherapy group (15·9-20·7; HR 0·69, 0·34-1·41). PFS and OS were longer with tepotinib plus gefitinib than with chemotherapy in patients with high (IHC3+) MET overexpression (n=34; median PFS 8·3 months [4·1-16·6] vs 4·4 months [4·1-6·8]; HR 0·35, 0·17-0·74; median OS 37·3 months [90% CI 24·2-37·3] vs 17·9 months [12·0-20·7]; HR 0·33, 0·14-0·76) or MET amplification (n=19; median PFS 16·6 months [8·3-not estimable] vs 4·2 months [1·4-7·0]; HR 0·13, 0·04-0·43; median OS 37·3 months [90% CI not estimable] vs 13·1 months [3·25-not estimable]; HR 0·08, 0·01-0·51). The most frequent treatment-related grade 3 or worse adverse events were increased amylase (5 [16%] of 31 patients) and lipase (4 [13%]) concentrations in the tepotinib plus gefitinib group and anaemia (7 [30%] of 23 patients) and decreased neutrophil count (3 [13%]) in the chemotherapy group.
INTERPRETATION


Despite early study termination, in a preplanned subgroup analysis, our findings suggest improved anti activity for tepotinib plus gefitinib compared with standard chemotherapy in patients with EGFR-mutant NSCLC and MET amplification, warranting further exploration.
FUNDING


Merck KGaA.",2020,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","['From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group', 'patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition', 'patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study', 'n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group', 'patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification', 'n=24 in the chemotherapy group', 'enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries']","['Tepotinib plus gefitinib', 'standard chemotherapy', 'oral tepotinib 300 mg or 500 mg plus gefitinib', 'tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy']","['investigator-assessed progression-free survival (PFS', 'anti activity', 'Median OS', 'neutrophil count', 'median PFS', 'anaemia', 'intention-to-treat basis and safety', 'adverse events', 'PFS and OS', 'No dose-limiting toxicities', 'overall survival (OS) and safety', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18.0,0.166598,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ross Andrew', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'National University Cancer Institute, Singapore.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Zhejiang Medical University, Zhejiang, China.'}, {'ForeName': 'Yuh-Min', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Chest Medicine, Taipei Veteran General Hospital and School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Feng', 'Initials': 'CF', 'LastName': 'Chian', 'Affiliation': 'Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Daniel Shao Weng', 'Initials': 'DSW', 'LastName': 'Tan', 'Affiliation': 'National Cancer Center, Singapore.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bruns', 'Affiliation': 'Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Straub', 'Affiliation': 'Translational Medicine, Department of Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Johne', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scheele', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30154-5']
1230,32487334,Dexamethasone eardrop with grommet placement vs intratympanic steroid injection for sudden sensorineural hearing loss: A randomized prospective clinical trial.,"OBJECTIVES


The purpose of this study was to compare different means of intratympanic steroid delivery in the treatment of idiopathic sudden sensorineural hearing loss.
DESIGN


Prospective, multicentered, randomized controlled trial.
SETTING AND PARTICIPANTS


Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study. Patients were randomly divided into 2 groups according to delivery methods: group A received 4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application. Self-administered paper-based questionnaires were filled out to measure subjective pain scores, vertigo, anxiety, and overall satisfaction immediately after each procedure. Hearing threshold was measured with pure tone audiogram in the follow-up.
RESULTS


There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30). Grommet placement followed by dexamethasone eardrop application demonstrated a significant difference in shorter waiting time (24 min in grommet group vs 52 min in injection group; P < 0.01); and better overall satisfaction (1.6 in grommet group vs 2.5 in injection group; P < 0.05).
CONCLUSIONS


Grommet placement followed by dexamethasone eardrop application is a good alternative for a patient indicated for intratympanic steroid, with less administrative cost, shorter waiting time, and more satisfaction.",2020,There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30).,"['sudden sensorineural hearing loss', 'Fifty-six patients who fulfilled the inclusion criteria for idiopathic sudden sensorineural hearing loss who failed or were contraindicated for oral steroids were included in this study', 'idiopathic sudden sensorineural hearing loss']","['Dexamethasone eardrop with grommet placement vs intratympanic steroid injection', '4 sections of intratympanic dexamethasone injection and group B received grommet placement with dexamethasone delivery followed by 3 sections of dexamethasone ear drop application', 'intratympanic steroid delivery']","['subjective pain scores, vertigo, anxiety, and overall satisfaction', 'overall satisfaction', 'shorter waiting time', 'hearing threshold improvement']","[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1154187', 'cui_str': 'Ear drops'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",56.0,0.0352837,There was no statistical significance detected in hearing threshold improvement between both groups (P = 0.30).,"[{'ForeName': 'Wai Tsz', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong. Electronic address: waitsz@ent.cuhk.edu.hk.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Zee', 'Affiliation': 'School of Public Health, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Herbert S H', 'Initials': 'HSH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong. Electronic address: herbertshlee@gmail.com.'}, {'ForeName': 'Michael C F', 'Initials': 'MCF', 'LastName': 'Tong', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong, Hong Kong.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102515']
1231,32586526,Variants in ADRB1 and CYP2C9: Association with Response to Atenolol and Losartan in Marfan Syndrome.,"OBJECTIVE


To test whether variants in ADRB1 and CYP2C9 genes identify subgroups of individuals with differential response to treatment for Marfan syndrome through analysis of data from a large, randomized trial.
STUDY DESIGN


In a subset of 250 white, non-Hispanic participants with Marfan syndrome in a prior randomized trial of atenolol vs losartan, the common variants rs1801252 and rs1801253 in ADRB1 and rs1799853 and rs1057910 in CYP2C9 were analyzed. The primary outcome was baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3 years, assessed using mixed effects models.
RESULTS


Among 122 atenolol-assigned participants, the 70 with rs1801253 CC genotype had greater rate of improvement in aortic root z-score compared with 52 participants with CG or GG genotypes (Time × Genotype interaction P = .005, mean annual z-score change ± SE -0.20 ± 0.03 vs -0.09 ± 0.03). Among participants with the CC genotype in both treatment arms, those assigned to atenolol had greater rate of improvement compared with the 71 of the 121 assigned to losartan (interaction P = .002; -0.20 ± 0.02 vs -0.07 ± 0.02; P < .001). There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
CONCLUSIONS


In this exploratory study, ADRB1-rs1801253 was associated with atenolol response in children and young adults with Marfan syndrome. If these findings are confirmed in future studies, ADRB1 genotyping has the potential to guide therapy by identifying those who are likely to have greater therapeutic response to atenolol than losartan.",2020,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
","['250 white, non-Hispanic participants with Marfan syndrome', 'Marfan Syndrome', 'children and young adults with Marfan syndrome']","['atenolol vs losartan', 'losartan', 'Atenolol and Losartan', 'atenolol']","['atenolol response', 'rate of improvement in aortic root z-score', 'rate of improvement', 'baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3\xa0years, assessed using mixed effects models']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",52.0,0.139844,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status.
","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Gelb', 'Affiliation': 'Mindich Child Health and Development Institute, Departments of Pediatrics and Genetics & Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shaine A', 'Initials': 'SA', 'LastName': 'Morris', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Dietz', 'Affiliation': 'Institute of Genetic Medicine, Johns Hopkins University School of Medicine and Howard Hughes Medical Institute, Baltimore, MD.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Forbus', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': ""Division of Cardiology, Children's Hospital of Philadelphia, Department of Pediatrics University of Pennsylvania Perlman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Hoskoppal', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Utah and Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'James', 'Affiliation': ""Department of Pediatrics, Section of Cardiology, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Levine', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Loeys', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Josephina A N', 'Initials': 'JAN', 'LastName': 'Meester', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mital', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mosley', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'Center for Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Shaffer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sharkey', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, MO.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Pharmacology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.064']
1232,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
1233,32597621,Effects of acute cooling on cycling anaerobic exercise performance and neuromuscular activity: a randomized crossover study.,"BACKGROUND


While cryotherapy is known for its favorable long-term recovery effects on muscle-damaging eccentric and plyometric exercises, studies showed that cryotherapy when used as an acute recovery mode (same day) had a negligible or negative effect on high-intensity and explosive exercises. However, there is lack of evidence regarding the mechanisms underlying the detrimental effect of acute cooling on the anaerobic performance. We hypothesized that acute cooling for the lower body would reduce anaerobic power output during a subsequent Wingate anaerobic tests (WAnT), which is at least in part due to decreased neuromuscular firing rate as indexed by mean frequency.
METHODS


We performed a randomized crossover design experiment. Eleven young healthy males completed two consecutive 30-sec Wingate anaerobic tests (WAnT 1 and 2). Subjects rested for 10 min between the WAnT 1 and the WAnT 2. Neuromuscular activity on the rectus femoris of both legs was recorded using wireless electromyography (EMG) during WAnT.
RESULTS


Anaerobic power during the first 5 sec of WAnT 2 was decreased in the cooling suit recovery group relative to WAnT 1. Mean frequency (MNF) in WAnT 2 was also lower in a cooled leg during WAnT 2 during the first 10 sec when compared with WAnT 1.
CONCLUSIONS


Acute cooling application blunts the initial phase of anaerobic power output during a subsequent WAnT, which could be explained by a concomitant reduction in neuromuscular firing rate. Given that cryotherapy is widely utilized in a variety of sports, athletes and trainers should pay close attention to the appropriate application of cryotherapy.",2020,"MNF in WAnT 2 was also lower in a cooled leg during WAnT 2 during the first 10 sec when compared with WAnT 1.
",['11 young healthy males'],"['acute cooling', 'cryotherapy']",['cycling anaerobic exercise performance and neuromuscular activity'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",11.0,0.0486034,"MNF in WAnT 2 was also lower in a cooled leg during WAnT 2 during the first 10 sec when compared with WAnT 1.
","[{'ForeName': 'Sukwon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Education, Motion Analysis Laboratory, Jeonbuk National University, Jeonju, South Korea.'}, {'ForeName': 'Chansol', 'Initials': 'C', 'LastName': 'Hurr', 'Affiliation': 'Department of Physical Education, Integrative Exercise Physiology Laboratory, Jeonbuk National University, Jeonju, South Korea - chansolh@jbnu.ac.kr.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11044-2']
1234,32605239,Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial.,"BACKGROUND


The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N).
METHODS


Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS.
RESULTS


Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant ( p  < 0.0001). The differences were statistically significant between the U and P groups (difference -48; 95% CI from -54 to -41) favoring the P group, and between the U and H groups (difference -45; 95% CI from -52 to -39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from -2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant ( p  < 0.0001) favoring the P and H groups.
CONCLUSIONS


The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.",2020,"The differences between treatments in clean mouth VAS was statistically significant ( p  < 0.0001) favoring the P and H groups.
","['Eligible participants were volunteer students', 'Dental Plaque Removal', 'Twenty-two participants']","['conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N', 'U-Shaped Automatic Electric Toothbrush']","['visual analogic scale (VAS) on subjective clean mouth sensation', 'clean mouth VAS', 'reduction in full-mouth plaque score (FMPS', 'FMPS reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.133698,"The differences between treatments in clean mouth VAS was statistically significant ( p  < 0.0001) favoring the P and H groups.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, Orthodontics, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Giuntini', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Pagliaro', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Giani', 'Affiliation': 'Private Practice, Campi Bisenzio, 50013 Firenze, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Franchi', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Franceschi', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17134649']
1235,32605389,Management of Migrated or Residual Stones Following Laparoscopic Pyelolithotomy and Ureterolithotomy in Abnormal Kidneys: A Prospective and Randomized Comparison.,"Objective:  To conduct a prospective and randomized controlled trial comparing contemporaneous transabdominal rigid ureteroscopy (TRU) with postoperative extracorporeal shockwave lithotripsy (SWL) in the management of migrated or residual stones during laparoscopic pyelolithotomy and ureterolithotomy in kidneys with either intrinsic or extrinsic abnormalities.  Materials and Methods:  From February 2016 to December 2019, 45 patients with migrated or residual stones following laparoscopic pyelolithotomy and ureterolithotomy were accrued and randomly divided into two groups. These patients all had either urinary tract obstruction distal to the stone or concomitant ipsilateral intrinsic or extrinsic pathology requiring laparoscopic intervention. Twenty-three patients underwent contemporaneous TRU, and 22 patients underwent postoperative SWL. Patients' demographics, perioperative variables, and follow-up data were collected. The primary outcome was the final stone-free rate (SFR) at the 2-month follow-up. Secondary outcomes included blood loss, operative time, change in serum creatinine, complications per Clavien-Dindo grading system, renal colic occurrence rate (RCOR), and postoperative hospitalization.  Results:  There was no significant difference in gender, age, body mass index, location, or stone burden between the two groups ( p  > 0.05). At the 2-month follow-ups, the SFR was higher in the TRU than the SWL group ( p  = 0.002), and the RCOR was lower in the TRU than the SWL group ( p  = 0.005). Postoperative hospitalization was also shorter for the TRU group. No significant difference was noted in the operative time, blood loss, change in serum creatinine, or perioperative complications ( p  > 0.05).  Conclusion:  Contemporaneous TRU is more effective and equally safe compared to postoperative SWL in the management of residual or migrated stones during laparoscopic pyelolithotomy and ureterolithotomy in kidneys with either intrinsic or extrinsic abnormalities.",2020,"At the two-month follow ups, the SFR was higher in the TRU than the SWL group (P = 0.002), and the RCOR was lower in the TRU than the SWL group (P = 0.005).","['patients all had either urinary tract obstruction distal to the stone or concomitant ipsilateral intrinsic or extrinsic pathology requiring laparoscopic intervention', 'Methods From February 2016 to December 2019, 45 patients with migrated or residual stones following laparoscopic pyelolithotomy and ureterolithotomy', '23 patients underwent', 'migrated or residual stones during laparoscopic pyelolithotomy and ureterolithotomy in kidneys with either intrinsic or extrinsic abnormalities']","['postoperative SWL', 'contemporaneous TRU', 'laparoscopic pyelolithotomy and ureterolithotomy', 'contemporaneous transabdominal rigid ureteroscopy (TRU) with postoperative shock wave lithotripsy (SWL']","['RCOR', 'gender, age, body mass index, location, or stone burden', 'blood loss, operative time, change in serum creatinine, complications per Clavien-Dindo grading system, renal colic occurrence rate (RCOR), and postoperative hospitalization', 'Postoperative hospitalization', 'operative time, blood loss, change in serum creatinine, or perioperative complications', 'final stone free rate (SFR', 'SFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178879', 'cui_str': 'Urinary tract obstruction'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2959846', 'cui_str': 'Laparoscopic pyelolithotomy'}, {'cui': 'C0194229', 'cui_str': 'Ureterolithotomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0032792', 'cui_str': 'Postoperative shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C2959846', 'cui_str': 'Laparoscopic pyelolithotomy'}, {'cui': 'C0194229', 'cui_str': 'Ureterolithotomy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",45.0,0.0492596,"At the two-month follow ups, the SFR was higher in the TRU than the SWL group (P = 0.002), and the RCOR was lower in the TRU than the SWL group (P = 0.005).","[{'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Shubo', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Urology, National Urological Cancer Center, Peking University First Hospital, The Institute of Urology, Peking University, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Nengzhuo', 'Initials': 'N', 'LastName': 'Feng', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Qiyan', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Kunlin', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, National Urological Cancer Center, Peking University First Hospital, The Institute of Urology, Peking University, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Urology, People's Hospital of Yangjiang, Yangjiang, China.""}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, National Urological Cancer Center, Peking University First Hospital, The Institute of Urology, Peking University, Beijing, China.'}]",Journal of endourology,['10.1089/end.2020.0296']
1236,32485112,"Effect of Platelet-Rich Plasma on Nonsurgically Treated Acute Achilles Tendon Ruptures: A Randomized, Double-Blinded Prospective Study.","BACKGROUND


An acute Achilles tendon rupture (ATR) is a long-lasting and devastating injury. Possible biological augmentation to promote and strengthen tendon healing after an ATR would be desirable.
PURPOSE


To determine whether the application of a platelet-rich plasma (PRP) injection in nonsurgically treated ATRs may promote healing and thereby improve functional outcomes.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months. All patients were treated with an orthosis with 3 wedges for 8 weeks; full weightbearing from day 1 was allowed, combined with either 4 PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin) 14 days apart. All patients received the same instructions on an exercise program starting from week 9. Outcomes included the self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion.
RESULTS


The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group). No differences in all functional outcomes at any time points were seen between the groups. At 12 months, the injured leg did not reach normal functional values compared with the uninjured leg.
CONCLUSION


The application of PRP in nonsurgically treated ATRs did not appear to show any superior clinical and functional improvement.
REGISTRATION


NCT02417922 (ClinicalTrials.gov identifier).",2020,"The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","['40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months', 'Nonsurgically Treated Acute Achilles Tendon Ruptures']","['PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin', 'Platelet-Rich Plasma', 'platelet-rich plasma (PRP) injection']","['self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion', 'mean ATRS score']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",72.0,0.431477,"The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","[{'ForeName': 'Anders Ploug', 'Initials': 'AP', 'LastName': 'Boesen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Ilum', 'Initials': 'MI', 'LastName': 'Boesen', 'Affiliation': 'Department Of Orthopaedics, Køge Sygehus, Køge, Denmark.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopaedic Surgery, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lenskjold', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Section of Social Medicine, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of sports medicine,['10.1177/0363546520922541']
1237,32589230,Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.,"Importance


Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic.
Objective


To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer.
Design, Setting, and Participants


This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019.
Interventions


Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily).
Main Outcomes and Measures


The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction.
Results


Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06; 95% CI, 0.01-0.25; P < .001) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20; 95% CI, 2.67-31.82; P < .001).
Conclusions and Relevance


These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent.
Trial Registration


ClinicalTrials.gov Identifier: NCT02366871.",2020,"There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%];","['postoperative patients with gynecologic cancer', 'Interventions\n\n\nWomen', 'gynecologic cancer', 'Women undergoing surgery for suspected or confirmed gynecologic cancer', '2015 to March 2019 in outpatient and inpatient gynecologic oncology settings', '500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received', 'Women Undergoing Surgery for Gynecologic Malignant Neoplasm']","['apixaban or enoxaparin', 'apixaban', 'Apixaban vs Enoxaparin', 'enoxaparin', 'oral apixaban']","['Participant satisfaction', 'rates of major bleeding and clinically relevant nonmajor bleeding events', 'race/ethnicity, cancer stage, or surgery modality', 'Postoperative Venous Thromboembolism', 'clinically relevant nonmajor bleeding events', 'venous thromboembolic events', 'safety and efficacy', 'pain', 'incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction', 'major bleeding and clinically relevant nonmajor bleeding events', 'rates of major bleeding events', 'adverse events, medication adherence, or quality of life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",400.0,0.236392,"There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%];","[{'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Breed', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Babayan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Amin A', 'Initials': 'AA', 'LastName': 'Ramzan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Wheeler', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Bradley R', 'Initials': 'BR', 'LastName': 'Corr', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lefkowits', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Keck School of Medicine, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Flink', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7410']
1238,32589237,Effects of catheter orifice configuration (triple-hole versus end-hole) in continuous infraclavicular brachial plexus block on analgesia after upper limb surgery.,"BACKGROUND


The configuration of a nerve block catheter may affect the local anesthetic spread in epidural analgesia and continuous peripheral nerve blocks. This prospective and randomized study aims to compare the multi-orifice nerve block catheter with an end-hole catheter in ultrasound-guided continuous infraclavicular brachial plexus block (BPB) in terms of providing postoperative analgesia for the orthopedic upper limb surgery below the shoulder. The primary outcome measure was mean pain scores. Secondary outcome measures were the consumption of rescue analgesic and the amount of local anesthetics delivered by a Patient-Controlled Analgesia (PCA) device.
METHODS


A total of 58 adult patients who underwent orthopedic upper limb surgery below the shoulder were randomly assigned into two groups: group end-hole catheter (EHC) (n=31) and group multi-orifice catheter (MOC) (n=27). All patients received a single-shot infraclavicular BPB using 100 mg lidocaine 2% and 75 mg bupivacaine 0.5% administrated through a Tuohy needle. Then, a multi-orifice (triple-hole) nerve catheter was placed in the group MOC and an end-hole (one-hole) catheter in the group EHC at the same location. Bupivacaine 0.125% was infused through the catheters via PCA (infusion rate: 2 mlh-1, automated regular bolus: 5 mlh-1, patient-controlled bolus: 3 ml, lock-out time: 1 hour, 4 hours limit: 40 ml). Pain intensity was evaluated using a visual analogue scale (VAS).
RESULTS


Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001). Mean rescue analgesic consumption, the number of bolus demand on PCA, PCA bolus demand dose, and total PCA dose were higher in group EHC than group MOC during the first postoperative day (p<0.05).
CONCLUSION


It is concluded that the use of MHC is more effective than EHC for continuous infraclavicular brachial plexus blocks in providing postoperative pain relief during the first 24 hours.",2020,"RESULTS


Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001).","['58 adult patients who underwent orthopedic upper limb surgery below the shoulder', 'continuous infraclavicular brachial plexus block on analgesia after upper limb surgery', 'orthopedic upper limb surgery below the shoulder']","['EHC', 'catheter orifice configuration (triple-hole versus end-hole', 'Bupivacaine', 'bupivacaine', 'group end-hole catheter (EHC) (n=31) and group multi-orifice catheter (MOC) ', 'lidocaine', 'multi-orifice nerve block catheter with an end-hole catheter in ultrasound-guided continuous infraclavicular brachial plexus block (BPB', 'MHC']","['visual analogue scale (VAS', 'Pain intensity', 'consumption of rescue analgesic and the amount of local anesthetics delivered by a Patient-Controlled Analgesia (PCA) device', 'mean pain scores', 'Mean rescue analgesic consumption, the number of bolus demand on PCA, PCA bolus demand dose, and total PCA dose', 'Mean VAS scores', 'postoperative pain relief']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",58.0,0.068495,"RESULTS


Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001).","[{'ForeName': 'Mehmet Burak', 'Initials': 'MB', 'LastName': 'Eskin', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Gülhane Faculty of Medicine, Ankara -Turkey.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Ceylan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Gülhane Training and Research Hospital, Ankara-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.03302']
1239,32590148,Physical and mental health effects of repeated short walks in a blue space environment: A randomised crossover study.,"INTRODUCTION


Blue spaces may benefit mental health and promote physical activity, although the evidence is still scarce. And benefits on physical health are less consistent. The objective of this randomized crossover study was to assess psychological and cardiovascular responses to blue spaces' exposure.
METHODS


A sample of 59 healthy adult office workers was randomly assigned to a different environment (i.e. blue space, urban space, and control site) on 4 days each week, for 3 weeks. For 20 min per day, they either walked along a blue or an urban space or rested at a control site. Before, during and/or after the exposure, we measured self-reported well-being and mood, blood pressure, and heart rate variability parameters. For well-being, we also assessed the duration of these potential effects over time (at least 4 h after exposure).
RESULTS


We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site. Cardiovascular responses showed increased activity of the sympathetic nervous system, both during and after walking along the blue and urban spaces. However, cardiovascular responses measured after the walks, showed no statistically significant differences between the blue and the urban space environments.
CONCLUSIONS


Short walks in blue spaces can benefit both well-being and mood. However, we did not observe a positive effect of blue spaces for any of the cardiovascular outcomes assessed in this study.",2020,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,['59 healthy adult office workers'],[],"['psychological and cardiovascular responses', 'cardiovascular responses', 'self-reported well-being and mood, blood pressure, and heart rate variability parameters', 'well-being and mood responses', 'Physical and mental health effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",59.0,0.0763709,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vert', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Ranzani', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Márquez', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Triguero-Mas', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain; Institute for Environmental Science and Technology, Barcelona, Spain; IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Barcelona Lab for Urban Environmental Justice and Sustainability, Barcelona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Carrasco-Turigas', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arjona', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Llopis', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Donaire-Gonzalez', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Institute for Risk Assessment Sciences (IRAS), Division of Environmental Epidemiology (EEPI), Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lewis R', 'Initials': 'LR', 'LastName': 'Elliott', 'Affiliation': 'European Centre for Environment and Human Health, University of Exeter Medical School, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nieuwenhuijsen', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: mark.nieuwenhuijsen@isglobal.org.'}]",Environmental research,['10.1016/j.envres.2020.109812']
1240,32591246,"The Automated Bone Scan Index as a Predictor of Response to Prostate Radiotherapy in Men with Newly Diagnosed Metastatic Prostate Cancer: An Exploratory Analysis of STAMPEDE's ""M1|RT Comparison"".","BACKGROUND


Prostate radiotherapy (RT) is a first-line option for newly diagnosed men with low-burden metastatic prostate cancer. The current criterion to define this clinical state is based on manual bone metastasis counts, but enumeration of bone metastases is limited by interobserver variations, and it does not account for metastasis volume or lesional coalescence. The automated bone scan index (aBSI) is a quantitative method of evaluating bone metastatic burden in a standardised and reproducible manner.
OBJECTIVE


To evaluate whether aBSI has utility as a predictive imaging biomarker to define a newly diagnosed metastatic prostate cancer population that might benefit from the addition of prostate RT to standard of care (SOC) systemic therapy.
DESIGN, SETTING, AND PARTICIPANTS


This is an exploratory analysis of men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either SOC or SOC + prostate RT within the STAMPEDE ""M1|RT comparison"".
INTERVENTION


The SOC was lifelong androgen deprivation therapy, with up-front docetaxel permitted from December 2015. Men allocated RT received either a daily or a weekly schedule that was nominated before randomisation.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Baseline bone scans were evaluated retrospectively to calculate aBSI. We used overall (OS) and failure-free (FFS) survival as the end points. Treatment-aBSI interaction was evaluated using the multivariable fractional polynomial interaction (MFPI) and subpopulation treatment effect pattern plot. Further analysis was done in aBSI quartiles using Cox regression models adjusted for stratification factors.
RESULTS AND LIMITATIONS


Baseline bone scans for 660 (SOC: 323 and SOC + RT: 337) of 2061 men randomised within the ""M1|RT comparison"" met the software requirements for aBSI calculation. The median age was 68 yr, median PSA was 100 ng/mL, median aBSI was 0.9, and median follow-up was 39 mo. Baseline patient characteristics including aBSI were balanced between the treatment groups. Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure). Graphical evaluation of estimated treatment effect plots showed that the OS and FFS benefit from prostate RT was greatest in patients with a low aBSI. Further analysis in quartiles based on aBSI supported this finding.
CONCLUSIONS


A low automated bone scan index is predictive of survival benefit associated with prostate RT in men with newly diagnosed metastatic prostate cancer.
PATIENT SUMMARY


The widely used bone scan can be evaluated using an automated technique to potentially select men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy.",2020,"Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure).","['men with newly diagnosed metastatic prostate cancer who might benefit from prostate radiotherapy', 'newly diagnosed men with low-burden metastatic prostate cancer', 'men with newly diagnosed metastatic prostate cancer randomised in a 1:1 ratio to either', 'men with newly diagnosed metastatic prostate cancer', 'patients with a low aBSI', 'Men with Newly Diagnosed Metastatic Prostate Cancer', 'newly diagnosed metastatic prostate cancer population', 'Baseline bone scans for 660 (SOC: 323 and SOC\u2009+\u2009RT: 337) of 2061 men']","['aBSI', 'Prostate Radiotherapy', 'Prostate radiotherapy (RT', 'SOC or SOC\u2009+\u2009prostate RT']","['aBSI', 'overall (OS) and failure-free (FFS) survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948317', 'cui_str': 'Radiotherapy to prostate'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",2061.0,0.146123,"Using the MFPI procedure, there was evidence of aBSI-treatment interaction for OS (p = 0.04, MFPI procedure) and FFS (p <  0.01, MFPI procedure).","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Alex P', 'Initials': 'AP', 'LastName': 'Hoyle', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK; Department of Urology, The Salford NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Brawley', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Amos', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Calvert', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Douis', 'Affiliation': 'Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Royal Marsden Hospital and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester, UK; FASTMAN Centre of Prostate Cancer Excellence, Manchester Cancer Research Centre, Manchester, UK; Department of Surgery, The Christie NHS Foundation Trust, Manchester, UK; Department of Urology, The Salford NHS Foundation Trust, Manchester, UK. Electronic address: noel.clarke@christie.nhs.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.05.003']
1241,32593046,"An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.","Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis.
METHODS


292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), ""therapeutic benefit"" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants.
RESULTS


The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a ""therapeutic benefit"" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs.
CONCLUSION


The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant ""therapeutic benefit"" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.",2020,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"['children, aged 6 to 11\u202fyears with acute viral and post-viral rhinosinusitis', '292 children aged 6 to 11\u202fyears with ARS', 'children with acute rhinosinusitis', 'Acute rhinosinusitis (ARS', 'patients with acute rhinosinusitis', 'acute rhinosinusitis in children aged 6 to 11\u202fyears']",['5 plant - extract BNO'],"['efficacy, safety and tolerability', ""patient's self-scoring of rhinorrhea"", 'severity of rhinorrhea, nasal congestion and post-nasal drip']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032081', 'cui_str': 'Plant extract'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}]",292.0,0.0255448,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"[{'ForeName': 'Vasyl I', 'Initials': 'VI', 'LastName': 'Popovych', 'Affiliation': 'ENT - Department of Ivano-Frankivsk National Medical University, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine. Electronic address: popovych_ent@ukr.net.'}, {'ForeName': 'Halyna V', 'Initials': 'HV', 'LastName': 'Beketova', 'Affiliation': 'Department of Children and Adolescent Diseases of the National Academy of Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}, {'ForeName': 'Ivana V', 'Initials': 'IV', 'LastName': 'Koshel', 'Affiliation': 'Department of Therapy and Family Medicine of Institute of Postgraduate Education of Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine.'}, {'ForeName': 'Olha A', 'Initials': 'OA', 'LastName': 'Tsodikova', 'Affiliation': 'Department of Outpatient Pediatrics KhMAPE, 58 Amosova Street, Kharkiv, Kharkiv Region 61176, Ukraine.'}, {'ForeName': 'Tetiana A', 'Initials': 'TA', 'LastName': 'Kriuchko', 'Affiliation': 'Department of Pediatrics №2 of Ukrainian Dental Academy, European Street, 39, Poltava, Poltava Region 36011, Ukraine.'}, {'ForeName': 'Aleksandr E', 'Initials': 'AE', 'LastName': 'Abaturov', 'Affiliation': 'Department of Pediatrics and Medical Genetics of Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Liudmyla I', 'Initials': 'LI', 'LastName': 'Vakulenko', 'Affiliation': 'Department of Pediatrics No. 2, Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Iurii V', 'Initials': 'IV', 'LastName': 'Gavrylenko', 'Affiliation': 'Department of Pediatric Otolaryngology of the National Academy of the Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102564']
1242,32595176,Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients　- Final 2-Year Follow-up Outcome Data From the SALUTE Trial.,"BACKGROUND


The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results:A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA 2 DS 2 -VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score.
CONCLUSIONS


Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT03033134).",2020,"All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal.","['Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation', 'Japanese Nonvalvular Atrial Fibrillation Patients', 'patients with nonvalvular atrial fibrillation (NVAF) in Japan', '54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers', 'All 42 subjects in the intention to treat (ITT) cohort underwent']","['Left Atrial Appendage Closure', 'left atrial appendage closure (LAAC) device', 'successful implantation of the LAAC device']","['Efficacy and Safety', 'baseline CHA 2 DS 2 -VASc score', 'hemorrhagic stroke or systemic embolism', 'safety and efficacy', 'modified Rankin scale score', 'effective LAAC rate']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}]",54.0,0.0923228,"All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal.","[{'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Aonuma', 'Affiliation': 'Cardiovascular Division, University of Tsukuba Hospital.'}, {'ForeName': 'Hiro', 'Initials': 'H', 'LastName': 'Yamasaki', 'Affiliation': 'Cardiovascular Division, University of Tsukuba Hospital.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine, Toho University Ohashi Medical Center.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Sendai Kousei Hospital.'}, {'ForeName': 'Morimasa', 'Initials': 'M', 'LastName': 'Takayama', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Division of Cardiology, Kokura Memorial Hospital.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Department of Cardiology, AOI Universal Hospital.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Goya', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Medical and Dental University.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Hayashida', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Gomi', 'Affiliation': 'Boston Scientific Japan K.K.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Main', 'Affiliation': ""Saint Luke's Mid America Heart Institute.""}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University.""}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0196']
1243,32607803,Perfusion in hand arthritis on dynamic contrast-enhanced computed tomography: a randomized prospective study using MRI as a standard of reference.,"OBJECTIVE


To evaluate the performance of dynamic contrast-enhanced CT (DCE-CT) in detecting and quantitatively assessing perfusion parameters in patients with arthritis of the hand compared with dynamic contrast-enhanced MRI (DCE-MRI) as a standard of reference.
MATERIALS AND METHODS


In this IRB-approved randomized prospective single-centre study, 36 consecutive patients with suspected rheumatoid arthritis underwent DCE-CT (320-row, tube voltage 80 kVp, tube current 8.25 mAs) and DCE-MRI (1.5 T) of the hand. Perfusion maps were calculated separately for mean transit time (MTT), time to peak (TTP), relative blood volume (rBV), and relative blood flow (rBF) using four different decomposition techniques. Region of interest (ROI) analysis was performed in metacarpophalangeal joints II-V and in the wrist. Pairs of perfusion parameters in DCE-CT and DCE-MRI were compared using a two-tailed t test for paired samples and interpreted for effect size (Cohen's d). According to the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) scoring results, differentiation of synovitis-positive and synovitis-negative joints with both modalities was assessed with the independent t test.
RESULTS


The two modalities yielded similar perfusion parameters. Identified differences had small effects (d 0.01-0.4). DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation. The total dose-length product (DLP) was 48 mGy*cm with an estimated effective dose of 0.038 mSv.
CONCLUSION


DCE-CT is a promising imaging technique in arthritis. In patients with a contraindication to MRI or when MRI is not available, DCE-CT is a suitable alternative to detect and assess arthritis.",2021,DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation.,"['36 consecutive patients with suspected rheumatoid arthritis underwent', 'patients with arthritis of the hand compared with dynamic contrast-enhanced MRI (DCE-MRI']","['dynamic contrast-enhanced computed tomography', 'dynamic contrast-enhanced CT (DCE-CT', 'DCE-CT', 'DCE-CT (320-row, tube voltage 80\xa0kVp, tube current 8.25\xa0mAs) and DCE-MRI']","['total dose-length product (DLP', 'mean transit time (MTT), time to peak (TTP), relative blood volume (rBV), and relative blood flow (rBF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0409208', 'cui_str': 'Arthritis of hand'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",36.0,0.0411065,DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation.,"[{'ForeName': 'Sevtap Tugce', 'Initials': 'ST', 'LastName': 'Ulas', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Kay Geert', 'Initials': 'KG', 'LastName': 'Hermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Makowski', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Biesen', 'Affiliation': 'Department of Rheumatology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Proft', 'Affiliation': 'Department of Rheumatology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Schilling', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany. torsten.diekhoff@charite.de.'}]",Skeletal radiology,['10.1007/s00256-020-03526-5']
1244,32605106,Hemodynamic Adaptations Induced by Short-Term Run Interval Training in College Students.,"Perceived lack of time is one of the most often cited barriers to exercise participation. High intensity interval training has become a popular training modality that incorporates intervals of maximal and low-intensity exercise with a time commitment usually shorter than 30 min. The purpose of this study was to examine the effects of short-term run interval training (RIT) on body composition (BC) and cardiorespiratory responses in undergraduate college students. Nineteen males (21.5 ± 1.6 years) were randomly assigned to a non-exercise control (CON,  n  = 10) or RIT ( n  = 9). Baseline measurements of systolic and diastolic blood pressure, resting heart rate (HRrest), double product (DP) and BC were obtained from both groups. VO 2max  and running speed associated with VO 2peak  (sVO 2peak ) were then measured. RIT consisted of three running treadmill sessions per week over 4 weeks (intervals at 100% sVO 2peak , recovery periods at 40% sVO 2peak ). There were no differences in post-training BC or VO 2 max between groups ( p  > 0.05). HRrest ( p  = 0.006) and DP ( p  ≤ 0.001) were lower in the RIT group compared to CON at completion of the study. RIT lowered HRrest and DP in the absence of appreciable BC and VO 2max  changes. Thereby, RIT could be an alternative model of training to diminish health-related risk factors in undergraduate college students.",2020,HRrest ( p  = 0.006) and DP ( p  ≤ 0.001) were lower in the RIT group compared to CON at completion of the study.,"['undergraduate college students', 'College Students', 'Nineteen males (21.5 ± 1.6 years']","['non-exercise control (CON,  n  = 10) or RIT', 'Short-Term Run Interval Training', 'High intensity interval training', 'short-term run interval training (RIT']","['body composition (BC) and cardiorespiratory responses', 'VO 2max  and running speed associated with VO 2peak  (sVO 2peak ', 'systolic and diastolic blood pressure, resting heart rate (HRrest), double product (DP) and BC']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",3.0,0.0570308,HRrest ( p  = 0.006) and DP ( p  ≤ 0.001) were lower in the RIT group compared to CON at completion of the study.,"[{'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'García-Suárez', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rentería', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'García Wong-Avilés', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Franco-Redona', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Gómez-Miranda', 'Affiliation': 'Facultad de Deportes Tijuana, Universidad Autónoma de Baja California, Avenida Maclovio Herrera #4080, Colonia Francisco Villa, Tijuana 22615, Baja California, Mexico.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Aburto-Corona', 'Affiliation': 'Facultad de Deportes Tijuana, Universidad Autónoma de Baja California, Avenida Maclovio Herrera #4080, Colonia Francisco Villa, Tijuana 22615, Baja California, Mexico.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Plaisance', 'Affiliation': 'Department of Human Studies, University of Alabama at Birmingham, Education Building 901, 13th Street South, Birmingham, AL 35294, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Moncada-Jiménez', 'Affiliation': 'Human Movement Sciences Research Center (CIMOHU), University of Costa Rica, Ave. 31 Pavas, San José 1200, Costa Rica.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jiménez-Maldonado', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17134636']
1245,32611217,Public Perceptions of Artificial Intelligence and Robotics in Medicine.,"Objective:  To understand better the public perception and comprehension of medical technology such as artificial intelligence (AI) and robotic surgery. In addition to this, to identify sensitivity to their use to ensure acceptability and quality of counseling.  Subjects and Methods:  A survey was conducted on a convenience sample of visitors to the MN Minnesota State Fair ( n  = 264). Participants were randomized to receive one of two similar surveys. In the first, a diagnosis was made by a physician and in the second by an AI application to compare confidence in human and computer-based diagnosis.  Results:  The median age of participants was 45 (interquartile range 28-59), 58% were female ( n  = 154)  vs  42% male ( n  = 110), 69% had completed at least a bachelor's degree, 88% were Caucasian ( n  = 233)  vs  12% ethnic minorities ( n  = 31) and were from 12 states, mostly from the Upper Midwest. Participants had nearly equal trust in AI  vs  physician diagnoses. However, they were significantly more likely to trust an AI diagnosis of cancer over a doctor's diagnosis when responding to the version of the survey that suggested that an AI could make medical diagnoses ( p  = 9.32e-06). Though 55% of respondents ( n  = 145) reported that they were uncomfortable with automated robotic surgery, the majority of the individuals surveyed (88%) mistakenly believed that partially autonomous surgery was already happening. Almost all (94%,  n  = 249) stated that they would be willing to pay for a review of medical imaging by an AI if available.  Conclusion:  Most participants express confidence in AI providing medical diagnoses, sometimes even over human physicians. Participants generally express concern with surgical AI, but they mistakenly believe that it is already being performed. As AI applications increase in medical practice, health care providers should be cognizant of the potential amount of misinformation and sensitivity that patients have to how such technology is represented.",2020,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available.
","[""The median age of participants was 45 (IQR 28-59), 58% were female (n=154) vs. 42% male (n=110), 69% had completed at least a bachelor's degree, 88% were Caucasian (n=233) vs. 12% ethnic minorities (n=31) and were from 12 states, most from the Upper Midwest"", 'convenience sample of visitors to the MN Minnesota State Fair (n= 264']",[],['acceptability and quality of counseling'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2911689', 'cui_str': 'Fair'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",88.0,0.0315296,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available.
","[{'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stai', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heller', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McSweeney', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Rickman', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Blake', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ranveer', 'Initials': 'R', 'LastName': 'Vasdev', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Edgerton', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Resha', 'Initials': 'R', 'LastName': 'Tejpaul', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Arveen', 'Initials': 'A', 'LastName': 'Kalapara', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Regmi', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Papanikolopoulos', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Weight', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Journal of endourology,['10.1089/end.2020.0137']
1246,32614625,First-time handling of different inhalers by chronic obstructive lung disease patients.,"Background:  There is a lack of guidance on inhaler device selection and how to individualize inhaler choice when prescribed for the first-time. Aim of the work:  To compare different inhalers regarding ease of use and number of counseling attempts needed for correct handling in subjects with a first experience to such inhalers; also, to investigate if there is a correlation between total correct steps achievements and patient demographics/clinical variables. Method:  An open-label, non-drug interventional, cross-over study was conducted including 180 Egyptian patients with chronic obstructive pulmonary disease (COPD). The study evaluated handling of the most common inhalers in subjects with a first experience with them before hospital discharge. Subjects were randomized to handle 10 placebo inhalers including: [metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Diskus, Breezhaler, Ellipta, Easyhaler, Diskhaler, and Respimat] without receiving verbal or demonstrative instruction with allowable access to the patient information leaflets in native language supported by figures with enough time to read (baseline assessment). Subjects were then crossed-over to other inhalers with a first experience randomly. Inhalers with a reported past-experience were excluded. Inhaler-technique was assessed by using previously defined checklists, including essential steps and critical errors. The whole handling of the inhaler was demonstrated and the number of counseling attempts needed to correct handling was recorded. Patient demographics and clinical variables were recorded and correlated with correct handling steps. Results:  The baseline percentages of total correct steps achievements as mean ± SD were 50 ± 19, 52 ± 16, 58 ± 14, 60 ± 17, 64 ± 10, 67 ± 16, 72 ± 17, 73 ± 11, 77 ± 14 and 86 ± 11% for Respimat, pMDI, Diskhaler, Diskus, Aerolizer, Handihaler, Easyhaler, Turbohaler, Breezhaler, and Ellipta respectively with p < 0.001. Baseline percentages of participants with at least 1 critical error significantly differed between inhalers (p < 0.05) with Ellipta showing the lowest percentage (37%). pMDI, Diskhaler, and Respimat showed the highest percentages (100%, 97% and 94% respectively). The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05). Ellipta showed the highest percentage of participants with correct handling with no counseling (20%) and the highest percentage of participants achieved with one counseling attempt (78%). Diskhaler, pMDI, and Respimat were the only inhalers included in a fourth counseling attempt (15%, 9%, and 6% respectively). Weak and very weak correlations were found between patient demographics/clinical variables and percentages of total correct steps achievements. Conclusion:  Inhalers techniques greatly vary in their ease of use (self-explaining) ranging from easy inhalers (Ellipta) to intermediate inhalers (breezhaler, Easyhaler, Turbohaler, Aerolizer, Handihaler, and Diskus) followed by the most difficult inhalers (pMDI, Diskhaler, and Respimat). That must be considered when prescribing inhalers for the first time; choice of the inhaler should, in part, be based on ease of use and to be accompanied by repeated counseling.",2020,The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05).,"['chronic obstructive lung disease patients', 'subjects with a first experience with them before hospital discharge', 'subjects with a first experience to such inhalers', '180 Egyptian patients with chronic obstructive pulmonary disease (COPD']","['placebo inhalers including: [metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Diskus, Breezhaler, Ellipta, Easyhaler, Diskhaler, and Respimat] without receiving verbal or demonstrative instruction with allowable access to the patient information leaflets in native language supported by figures with enough time to read (baseline assessment']","['Diskhaler, pMDI, and Respimat']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],180.0,0.0477912,The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05).,"[{'ForeName': 'Hadeer S', 'Initials': 'HS', 'LastName': 'Harb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Nabila Ibrahim', 'Initials': 'NI', 'LastName': 'Laz', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rabea', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",Experimental lung research,['10.1080/01902148.2020.1789903']
1247,32618383,Sotagliflozin added to optimized insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: A pooled analysis of inTandem1 and inTandem2.,"AIM


To evaluate whether the addition of sotagliflozin to optimized insulin significantly increases the proportion of adults with type 1 diabetes who achieve HbA1c goals without weight gain.
MATERIALS AND METHODS


In a patient-level pooled analysis (n = 1575) of data from two phase 3, 52-week clinical trials (inTandem1 and inTandem2), the change from baseline in HbA1c and weight as well as the proportion of participants achieving an HbA1c of less than 7% without weight gain were compared between groups treated with placebo, sotagliflozin 200 mg and sotagliflozin 400 mg.
RESULTS


From a mean baseline HbA1c of 7.7%, mean HbA1c changes at week 24 were -0.36% (95% CI -0.44% to -0.29%) and -0.38% (-0.45% to -0.31%) with sotagliflozin 200 and 400 mg versus placebo (P = .001 for both), respectively, with sustained effects through week 52. Weight significantly decreased at weeks 24 and 52 in both sotagliflozin groups compared with placebo. At week 52, the proportion of patients who achieved an HbA1c of less than 7% without weight gain was 21.8% with sotagliflozin 200 mg, 26.1% with sotagliflozin 400 mg and 9.1% with placebo (P < .001). Other HbA1c, weight and safety composite variables showed similar significant trends.
CONCLUSION


When added to optimized insulin therapy, sotagliflozin improved glycaemic control and body weight and enabled more adults with type 1 diabetes to achieve HbA1c goals without weight gain over 52 weeks, although there was more diabetic ketoacidosis relative to placebo.",2020,"200 and 400 mg vs placebo (P = 0.001 for both), respectively, with sustained effects through week 52.","['adults with type 1 diabetes', 'adults with T1D who achieve HbA1c goals without weight gain', 'adults with type 1 diabetes (T1D']","['placebo, sotagliflozin 200\u2009mg, and sotagliflozin 400\u2009mg', 'insulin therapy, sotagliflozin', 'Sotagliflozin', 'sotagliflozin', 'placebo']","['mean HbA1c changes', 'Weight', 'weight gain', 'glycaemic control and body weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.29173,"200 and 400 mg vs placebo (P = 0.001 for both), respectively, with sustained effects through week 52.","[{'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants, Rockville, Maryland, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Lajara', 'Affiliation': 'Diabetes Centers of America-Dallas-Fort Worth, Plano, Texas, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Laval, Québec, Canada.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Strumph', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14127']
1248,32621630,A Mindfulness-Based Intervention as a Supportive Care Strategy for Patients with Metastatic Non-Small Cell Lung Cancer and Their Spouses: Results of a Three-Arm Pilot Randomized Controlled Trial.,"BACKGROUND


Although mindfulness-based interventions have been widely examined in patients with nonmetastatic cancer, the feasibility and efficacy of these types of programs are largely unknown for those with advanced disease. We pilot-tested a couple-based meditation (CBM) relative to a supportive-expressive (SE) and a usual care (UC) arm targeting psychospiritual distress in patients with metastatic lung cancer and their spousal caregivers.
PATIENTS AND METHODS


Seventy-five patient-caregiver dyads completed baseline self-report measures and were then randomized to one of the three arms. Couples in the CBM and SE groups attended four 60-minute sessions that were delivered via videoconference. All dyads were reassessed 1 and 3 months later.
RESULTS


A priori feasibility benchmarks were met. Although attendance was high in both groups, dyads in the CBM group indicated greater benefit of the sessions than those in the SE group (patients, CBM mean = 2.63, SE mean = 2.20, p = .003; spouses, CBM mean = 2.71, SE mean = 2.00, p = .005). Compared with the UC group, patients in the CBM group reported significantly lower depressive symptoms (p = .05; d = 0.53) and marginally reduced cancer-related stress (p = .07; d = 0.68). Medium effect sizes in favor of the CBM compared with the SE group for depressive symptoms (d = 0.59) and cancer-related stress (d = 0.54) were found. Spouses in the CBM group reported significantly lower depressive symptoms (p < .01; d = 0.74) compared with those in the UC group.
CONCLUSION


It seems feasible and possibly efficacious to deliver dyadic interventions via videoconference to couples coping with metastatic lung cancer. Mindfulness-based interventions may be of value to managing psychological symptoms in the palliative care setting. Clinical trial identification number. NCT02596490 IMPLICATIONS FOR PRACTICE: The current randomized controlled trial has established that a mindfulness approach to the management of patients' and spouses' psychospiritual concerns is acceptable and subjectively deemed more beneficial than a supportive-expressive treatment for patients with metastatic non-small cell lung cancer (NSCLC). We also revealed that videoconference delivery, here FaceTime, is an acceptable approach even for geriatric patients with metastatic NSCLC and that patients and their spousal caregivers prefer a dyadic delivery of this type of supportive care strategy. Lastly, this trial has laid the foundation for the role of mindfulness-based interventions in the palliative care setting supporting patients with advanced NSCLC and their spousal caregivers.",2020,"Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group.
","['patients with metastatic lung cancer and their spousal caregivers', 'patients with non-metastatic cancer', 'Patients with Metastatic Non-Small Cell Lung Cancer and their Spouses', 'Seventy-five patient-caregiver dyads completed baseline self-report measures']","['SE', 'couple-based mediation (CBM) relative to a supportive-expressive (SE) and a usual care (UC) arm targeting psycho-spiritual distress', 'UC', 'CBM']",['depressive symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150081', 'cui_str': 'Spiritual distress'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0403801,"Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group.
","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department\u2009of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department\u2009of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Department\u2009of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department\u2009of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'Department\u2009of Head and Neck/Thoracic Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carmack', 'Affiliation': 'Department\u2009of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department\u2009of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department\u2009of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0125']
1249,32627064,"The analgesic effect of tramadol combined with butorphanol on uterine cramping pain after repeat caesarean section: a randomized, controlled, double-blind study.","PURPOSE


This study aimed to explore the effect of patient-controlled intravenous analgesia (PCIA) using tramadol combined with butorphanol on uterine cramping pain in women undergoing repeat caesarean section.
METHODS


A total of 126 patients, who were scheduled to undergo repeat caesarean section under spinal anesthesia, were included. PCIA using tramadol combined with butorphanol or sufentanil was randomly performed for postoperative pain control. Postoperative uterine cramping pain and wound pain within 48 h after surgery were evaluated. Postoperative analgesic consumption, early activity time, and length of hospital stay were also recorded and analyzed.
RESULTS


Uterine cramping pain intensity in women undergoing repeat caesarean section was significantly higher compared with their wound pain (P < 0.05). The mean visual analog scale (VAS) score for uterine cramping pain in the tramadol-butorphanol group was significantly lower than that in the sufentanil group at rest, and at 6 h and 12 h after surgery. VAS scores for uterine cramping pain during movement at 6 h, 12 h, and 24 h after surgery in the tramadol-butorphanol group were also significantly lower than that in sufentanil group (P < 0.05). There was no significant difference in VAS score for wound pain at the different time points between the tramadol-butorphanol and sufentanil groups (P > 0.05). Patient-controlled intravenous analgesia with tramadol accelerated early rehabilitation and decreased the length of hospital stay (P < 0.05).
CONCLUSION


PCIA using tramadol combined with butorphanol provided a better analgesic effect and accelerated postoperative rehabilitation compared with sufentanil, and may be an optimal analgesic strategy for women undergoing repeat caesarean section.
CLINICAL TRIAL REGISTRATION


The trial was registered at Chinese Clinical Trial Registry ( www.chictr.org.cn ) with ID: ChiCTR-1800014986.",2020,"Patient-controlled intravenous analgesia with tramadol accelerated early rehabilitation and decreased the length of hospital stay (P < 0.05).
","['uterine cramping pain after repeat caesarean section', 'women undergoing repeat caesarean section', '126 patients, who were scheduled to undergo repeat caesarean section under spinal anesthesia, were included']","['butorphanol', 'sufentanil', 'tramadol', 'tramadol-butorphanol', 'butorphanol or sufentanil', 'tramadol combined with butorphanol', 'patient-controlled intravenous analgesia (PCIA']","['Uterine cramping pain intensity', 'wound pain', 'VAS score for wound pain', 'uterine cramping pain', 'mean visual analog scale (VAS) score for uterine cramping pain', 'length of hospital stay', 'postoperative pain control', 'Postoperative uterine cramping pain and wound pain', 'Postoperative analgesic consumption, early activity time, and length of hospital stay', 'analgesic effect and accelerated postoperative rehabilitation', 'VAS scores']","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0241745', 'cui_str': 'Wound pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]",126.0,0.264415,"Patient-controlled intravenous analgesia with tramadol accelerated early rehabilitation and decreased the length of hospital stay (P < 0.05).
","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology, General Hospital of Central Theater Command, Wuhan, China.'}, {'ForeName': 'Hanlin', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. qq8689948@126.com.'}]",Journal of anesthesia,['10.1007/s00540-020-02820-9']
1250,32627205,"Blood donor recruitment in Guangzhou, China, during the 2019 novel coronavirus (COVID-19) epidemic.","BACKGROUND


The coronavirus disease 2019 (COVID-19) epidemic affected blood collection in Guangzhou, China.
STUDY DESIGN AND METHODS


This paper includes three studies. The observational study reported the trends of blood collection during the epidemic in Guangzhou, China. The cross-sectional survey investigated factors influencing blood donation during the COVID-19 epidemic, and a self-administered questionnaire was given to 1584 street whole blood donors (SWBDs) who donated during the epidemic. The randomized controlled trial involved 19 491 SWBDs who donated in 2019 but did not donate during the epidemic. Trial participants were randomly assigned to two intervention groups: Group 1 completed Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; Group 2 completed Questionnaire 2, which did not include this information. A control group did not receive any questionnaire.
RESULTS


As measures were implemented, the number of blood donors increased accordingly. Both first-time and repeat SWBDs perceived the same level of blood need and donated blood because it would save lives. SWBDs who completed Questionnaire 1 expressed a greater intention to donate during the epidemic. Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within 3 weeks. Intention-to-treat analyses and average-treatment-effect-on-the-treated estimations confirmed that Questionnaire 1 could motivate SWBDs to actually donate blood.
CONCLUSION


Various measures could ease blood shortage during the COVID-19 epidemic. Administration of Questionnaire 1 could increase blood donations during the epidemic.",2020,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"['19,491 SWBDs who donated in 2019 but did not donate during the epidemic']","['Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; and group 2 completed Questionnaire 2, which did not include this information']","['blood donations', 'number of blood donors', 'blood shortage']","[{'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0375876', 'cui_str': 'Whole blood donor'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",19491.0,0.0277604,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ou-Yang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shi-Jie', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chun-Hua', 'Initials': 'CH', 'LastName': 'Bei', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jin-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hua-Qin', 'Initials': 'HQ', 'LastName': 'Liang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yong-Shui', 'Initials': 'YS', 'LastName': 'Fu', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}]",Transfusion,['10.1111/trf.15971']
1251,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1252,32623361,Immediate effects of valgus bracing on knee joint moments during walking in knee-healthy individuals: Potential modifying effects of body height.,"BACKGROUND


The goal of valgus knee brace treatment is to reduce medial knee joint loading during walking, often indicated by external knee adduction moment (KAM) measures. However, existing healthy-subjects studies have been equivocal in demonstrating KAM reduction with valgus knee bracing.
RESEARCH QUESTION


What are the immediate effects of valgus bracing at different tension levels on KAM during walking at a controlled speed and does body height modify the brace-KAM associations?
METHODS


Data from 32 knee-healthy participants were analysed in this randomized crossover trial. Participants performed walking trials at controlled speed (1.3 ± 0.065 m/s) both with and without an Ossür Unloader One® brace. During the bracing condition, valgus tension was incrementally increased, from zero tension to normal tension and to maximum tolerable tension.
RESULTS


Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels. Valgus bracing, overall, did not significantly reduce the various KAM measures. However, brace use at maximal tension was associated with a 0.04Nm/kg (9.2 %) increase in first peak KAM amongst participants with a body height of 1.75 m and a 0.03Nm/kg (7.6 %) decrease in first peak KAM amongst participants with a body height of 1.55 m.
SIGNIFICANCE


Valgus bracing did not reduce the various KAM measures during walking; however, body height may play a moderating role. Given knee brace sizes vary more in circumference than length, this result may be due to the ratio between effective moment arm length relative to limb length. A deeper understanding of the potential neuro-biomechanical effects of valgus knee bracing and how these effects are potentially modified by body height may be critical to the design of effective knee braces.",2020,Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels.,"['Data from 32 knee-healthy participants', 'knee-healthy individuals']",['valgus bracing'],"['gait velocity', 'various KAM measures', 'knee joint moments', 'knee flexion at heel-strike']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]",,0.0313931,Valgus bracing minimally increased knee flexion at heel-strike (P < 0.001) in a dose-dependent manner and minimally reduced gait velocity (∼0.015m/s) across all tension levels.,"[{'ForeName': 'Yong-Hao', 'Initials': 'YH', 'LastName': 'Pua', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: pua.yong.hao@sgh.com.sg.'}, {'ForeName': 'Hong-Han', 'Initials': 'HH', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: tan.hong.han@sgh.com.sg.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Mentiplay', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, La Trobe University, Victoria, Australia. Electronic address: b.mentiplay@latrobe.edu.au.'}, {'ForeName': 'Leon Zhi-Xia', 'Initials': 'LZ', 'LastName': 'Lim', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: leonlimzx@hotmail.com.'}, {'ForeName': 'Asher Chi-Weng', 'Initials': 'AC', 'LastName': 'Tham', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: ashertham@hotmail.com.'}, {'ForeName': 'Joshua Jia-En', 'Initials': 'JJ', 'LastName': 'Quek', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: Quek.joshua@gmail.com.'}, {'ForeName': 'Ee-Lin', 'Initials': 'EL', 'LastName': 'Woon', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore. Electronic address: woon.ee.lin@sgh.com.sg.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Yeh', 'Affiliation': 'Department of Health and Social Sciences, Singapore Institute of Technology, Singapore. Electronic address: tingting.yeh@singaporetech.edu.sg.'}, {'ForeName': 'Celia Ia-Choo', 'Initials': 'CI', 'LastName': 'Tan', 'Affiliation': 'Department of Physiotherapy, Singapore General Hospital, Singapore; SingHealth Group Allied Health, Singapore. Electronic address: celia.tan.i.c@singhealth.com.sg.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Hunt', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. Electronic address: michael.hunt@ubc.ca.'}, {'ForeName': 'Ross Allan', 'Initials': 'RA', 'LastName': 'Clark', 'Affiliation': 'Research Health Institute, University of the Sunshine Coast, Sunshine Coast, Australia. Electronic address: rclark@usc.edu.au.'}]",Gait & posture,['10.1016/j.gaitpost.2020.06.025']
1253,32631710,A randomized study comparing different doses of superparamagnetic iron oxide tracer for sentinel lymph node biopsy in breast cancer: The SUNRISE study.,"INTRODUCTION


The non-radioactive method that uses the magnetic tracer (SPIO/Sienna) has shown to be a feasible technique for the SLN detection in breast cancer patients. The aim of this study is to assess the efficacy of different doses of a new magnetic tracer Sienna XP (Magtrace) compared to Tc-99 m and to evaluate its non-inferiority.
METHODS


Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible and consecutively randomized to three different doses of new SPIO used: group 1 (1 mL), group 2 (1.5 mL) and group 3 (2 mL).
RESULTS


A total of 135 patients were included in the study, 45 in each group. Detection of SLNs with the three doses of Sienna XP (1 mL, 1.5 mL and 2 mL) showed non-inferior rates compared to the conventional technique with radiotracer (p = 0.654). Concordance by patients with SLN positive was 100% for all groups. 83 (70.3%) patients reported skin staining at one month postoperatively, significantly lower in group 1 (p = 0.042). At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01). In multivariate analysis, dose of 2 mL showed statistically significant for the skin staining. The majority of patients (70%) felt that skin discoloration does not represent a problem.
CONCLUSION


The use of the Sienna XP magnetic tracer at 1 mL is not inferior to higher doses of magnetic tracer neither is inferior to radiotracer. 1 mL of magnetic tracer resulted in significantly less skin discoloration compared to higher doses.",2020,"At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01).","['breast cancer patients', 'sentinel lymph node biopsy in breast cancer', 'A total of 135 patients were included in the study, 45 in each group', 'Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible']","['new magnetic tracer Sienna XP (Magtrace', 'superparamagnetic iron oxide tracer']","['skin staining', 'non-inferior rates', 'skin discoloration']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0246249', 'cui_str': 'ferumoxides'}]","[{'cui': 'C0423765', 'cui_str': 'Staining of skin'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}]",135.0,0.0842373,"At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01).","[{'ForeName': 'Isabel T', 'Initials': 'IT', 'LastName': 'Rubio', 'Affiliation': 'Breast Surgical Oncology, Clinica Universidad de Navarra, Madrid, Spain; Universidad de Navarra, Spain. Electronic address: irubior@unav.es.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rodriguez-Revuelto', 'Affiliation': 'Breast Center, Lucerne Cantonal Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Espinosa-Bravo', 'Affiliation': ""Breast Surgical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Siso', 'Affiliation': ""Breast Surgical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain; Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Rivero', 'Affiliation': ""Breast Surgical Oncology, Hospital Universitario Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Esgueva', 'Affiliation': 'Breast Surgical Oncology, Clinica Universidad de Navarra, Madrid, Spain; Universidad de Navarra, Spain.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.06.018']
1254,32597570,Promoting dietary awareness: Home-dwelling older adults' perspectives on using a nutrition application.,"AIMS AND OBJECTIVES


This study investigated older adults' experiences of using the Appetitus app with support from healthcare professionals.
BACKGROUND


Good nutrition status is important for good health when ageing. However, as undernutrition remains a prevalent and persistent problem among older adults, the study explored whether technology affords innovative support for nutritional self-care among older adults.
DESIGN


The study was explorative and qualitative in approach.
METHODS


Appetitus was developed as a tablet-based application to prevent and alleviate undernutrition among older adults. Eighteen home-dwelling older adults used the app for 8 weeks. Older adults received home care, and local healthcare professionals introduced the app and gave support during the study.
RESULTS


Appetitus served as a source of inspiration and a reminder of available, relevant food options. Appetitus encouraged some participants to eat or drink more by the end of the day while others became more aware of selecting food options to ensure sufficient protein, energy and fluids. However, some participants made no active effort to change their diet despite feedback from the app that suggested they did not eat or drink enough. Technical support from healthcare professionals facilitated participants' use of the app and tablet. Some participants also received more specific nutritional follow-up that helped to make their experience of using the app more meaningful.
CONCLUSION


Older adults' awareness about the importance of keeping a diet that helps prevent undernutrition was reinforced through the use of Appetitus and discussing nutrition with healthcare professionals.
IMPLICATION FOR PRACTICE


The findings affirm feasibility of using technology in nutritional interventions enhancing self-care among older adults.",2020,"Appetitus encouraged some participants to eat or drink more by the end of the day while others became more aware of selecting food options to ensure sufficient protein, energy and fluids.","['older adults', ""older adults' experiences of using the Appetitus app with support from healthcare professionals"", 'Older adults received home care, and local healthcare professionals introduced the app and gave support during the study', 'Eighteen home-dwelling older adults', 'dwelling older adults']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],[],18.0,0.015188,"Appetitus encouraged some participants to eat or drink more by the end of the day while others became more aware of selecting food options to ensure sufficient protein, energy and fluids.","[{'ForeName': 'Caroline Farsjø', 'Initials': 'CF', 'LastName': 'Aure', 'Affiliation': 'Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kluge', 'Affiliation': 'Department of Education, Faculty of Educational Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moen', 'Affiliation': 'Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",International journal of older people nursing,['10.1111/opn.12332']
1255,32601011,The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing.,"BACKGROUND


Various non-pharmacologic methods are used to alleviate pain in preterm infants who spend their first days in neonatal intensive care units (NICU) because they are exposed to numerous painful interventions.
OBJECTIVE


To determine the effects of Yakson and Gentle Human Touch (GHT) methods on pain and physiologic parameters during heel lancing procedures in preterm infants.
DESIGN AND METHODS


This was a randomised controlled trial. The study was conducted in a NICU between June 2018 and June 2019. A total of 90 preterm infants were divided into three groups: 30 infants in the Yakson group, 30 infants in the GHT group, and 30 infants in the control group. All preterm infants were randomly divided into groups. Pain responses were evaluated using the Neonatal Infant Pain Scale.
RESULTS


It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001).
PRACTICAL IMPLICATIONS


Yakson and GHT applied to preterm infants during heel lancing has positive effects on pain and physiologic parameters.",2020,"It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001).
","['NICU between June 2018 and June 2019', 'All preterm infants', '90 preterm infants were divided into three groups: 30 infants in the Yakson group, 30 infants in the GHT group, and 30 infants in the control group', 'preterm infants during heel lancing', 'preterm infants', 'preterm infants who spend their first days in neonatal intensive care units (NICU']","['Yakson and Gentle Human Touch (GHT) methods', 'Yakson and Gentle Human Touch methods']","['Neonatal Infant Pain Scale', 'pain scores and heart rates', 'pain and physiological parameters', 'pain and physiologic parameters', 'Pain responses']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",90.0,0.0465262,"It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001).
","[{'ForeName': 'Şadiye', 'Initials': 'Ş', 'LastName': 'Dur', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Bahçeşehir University, Istanbul, Turkey.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Çağlar', 'Affiliation': 'Pediatric Nursing Department, Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpaşa, Istanbul, Turkey. Electronic address: sedac@istanbul.edu.tr.'}, {'ForeName': 'Nagehan Ustabaş', 'Initials': 'NU', 'LastName': 'Yıldız', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Doğan', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}, {'ForeName': 'İpek', 'Initials': 'İ', 'LastName': 'Güney Varal', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102886']
1256,32609011,Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial.,"Rationale:  Exogenous angiotensin II increases mean arterial pressure in patients with catecholamine-resistant vasodilatory shock (CRVS). We hypothesized that renin concentrations may identify patients most likely to benefit from such therapy. Objectives:  To test the kinetic changes in renin concentrations and their prognostic value in patients with CRVS. Methods:  We analyzed serum samples from patients enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) trial for renin, angiotensin I, and angiotensin II concentrations before the start of administration of angiotensin II or placebo and after 3 hours. Measurements and Main Results:  Baseline serum renin concentration (normal range, 2.13-58.78 pg/ml) was above the upper limits of normal in 194 of 255 (76%) study patients with a median renin concentration of 172.7 pg/ml (interquartile range [IQR], 60.7 to 440.6 pg/ml), approximately threefold higher than the upper limit of normal. Renin concentrations correlated positively with angiotensin I/II ratios ( r  = 0.39;  P  < 0.001). At 3 hours after initiation of angiotensin II therapy, there was a 54.3% reduction (IQR, 37.9% to 66.5% reduction) in renin concentration compared with a 14.1% reduction (IQR, 37.6% reduction to 5.1% increase) with placebo ( P  < 0.0001). In patients with renin concentrations above the study population median, angiotensin II significantly reduced 28-day mortality to 28 of 55 (50.9%) patients compared with 51 of 73 patients (69.9%) treated with placebo (unstratified hazard ratio, 0.56; 95% confidence interval, 0.35 to 0.88;  P  = 0.012) ( P  = 0.048 for the interaction). Conclusions:  The serum renin concentration is markedly elevated in CRVS and may identify patients for whom treatment with angiotensin II has a beneficial effect on clinical outcomes.Clinical trial registered with www.clinicaltrials.gov (NCT02338843).",2020,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"['CRVS patients', 'patients with catecholamine-resistant vasodilatory shock (CRVS', 'Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock', 'patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of']","['placebo', 'angiotensin', 'angiotensin II therapy', 'angiotensin II or placebo']","['renin levels', 'Renin and Survival', 'Renin levels', 'renin concentration', 'Baseline serum renin concentration', '28-day mortality', 'mean arterial pressure', 'median renin concentration', 'Serum renin concentration']","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111806,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Department of Medicine & Radiology, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Unit, Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, and.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, School of Medicine, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'Department of Critical Care, Regions Hospital, University of Minnesota, St. Paul, Minnesota.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boldt', 'Affiliation': 'Division of Critical Care, Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, School of Medicine, University of California-Davis, Northern California Health System, Mather, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Renal Division, Department of Medicine, Emory University Medical Center, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, Guy's & St. Thomas' Hospital, King's College London, London, United Kingdom.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2172OC']
1257,32614141,Targeted Mass Spectrometry of a Clinically Relevant PSA Variant from Post-DRE Urines for Quantitation and Genotype Determination.,"PURPOSE


The rs17632542 single nucleotide polymorphism (SNP) results in lower serum prostate specific antigen (PSA) levels which may further mitigate against its clinical utility as a prostate cancer biomarker. Post-digital rectal exam (post-DRE) urine is a minimally invasive fluid that is currently utilized in prostate cancer diagnosis. To detect and quantitate the variant protein in urine.
EXPERIMENTAL DESIGN


Fifty-three post-DRE urines from rs17632542 genotyped individuals processed and analyzed by liquid chromatography/mass spectrometry (LC-MS) in a double-blinded randomized study. The ability to distinguish between homozygous wild-type, heterozygous, or homozygous variant is examined before unblinding.
RESULTS


Stable-isotope labeled peptides are used in the detection and quantitation of three peptides of interest in each sample using parallel reaction monitoring (PRM). Using these data, groupings are predicted using hierarchical clustering in R. Accuracy of the predictions show 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP.
CONCLUSIONS AND CLINICAL RELEVANCE


The study demonstrates that MS based peptide variant quantitation in urine could be useful in determining patient genotype expression. This assay provides a tool to evaluate the utility of PSA variant (rs17632542) in parallel with current and forthcoming urine biomarker panels.",2020,"Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP.
",['Fifty-three post-DRE urines from rs17632542 genotyped individuals'],[],"['peak detection and area extraction', 'serum PSA levels']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1384593', 'cui_str': 'Digital examination of rectum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}]",,0.0364145,"Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP.
","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Otto', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Correll', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Hampus A', 'Initials': 'HA', 'LastName': 'Engstroem', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Naomi L', 'Initials': 'NL', 'LastName': 'Hitefield', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Main', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Albracht', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Johnson-Pais', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Li Fang', 'Initials': 'LF', 'LastName': 'Yang', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liss', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Boutros', 'Affiliation': 'Departments of Human Genetics and Urology, Jonsson Comprehensive Cancer Center, Institute for Precision Health University of California Los Angeles, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kislinger', 'Affiliation': 'University of Toronto, Department of Medical Biophysics, Toronto, ON M5G 1L7, Canada.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Leach', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Semmes', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}, {'ForeName': 'Julius O', 'Initials': 'JO', 'LastName': 'Nyalwidhe', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA, 23507, USA.'}]",Proteomics. Clinical applications,['10.1002/prca.202000012']
1258,32610640,Be a Mom 's Efficacy in Enhancing Positive Mental Health among Postpartum Women Presenting Low Risk for Postpartum Depression: Results from a Pilot Randomized Trial.,"In this study, we conducted a preliminary investigation of the efficacy of  Be a Mom , a web-based self-guided intervention, in enhancing positive mental health among postpartum women at low risk for postpartum depression. Additionally, we examined  Be a Mom 's efficacy regarding secondary outcomes as well as its acceptability and adherence. A total of 367 participants were randomly assigned to the  Be a Mom  group ( n  = 191) or to the waiting-list control group ( n  = 176) and completed baseline (T1) and postintervention (T2) assessments. The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group. Additionally, group effects were found for depressive and anxiety symptoms. A significantly higher proportion of participants in the  Be a Mom  group had an improvement trajectory (from not flourishing at T1 to flourishing at T2). A total of 62 (32.5%) women completed  Be a Mom , and most would use it again if needed ( n  = 82/113; 72.6%). This study provides preliminary evidence of  Be a Mom 's efficacy in increasing positive mental health among low-risk postpartum women. Our findings support mental health promotion strategies in the postpartum period and highlight the important role of web-based CBT interventions.",2020,The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group.,"['Postpartum Women Presenting Low Risk for Postpartum Depression', 'postpartum women at low risk for postpartum depression', 'low-risk postpartum women', 'A total of 367 participants', 'A total of 62 (32.5%) women completed  Be a Mom']",['waiting-list control group'],"['depressive and anxiety symptoms', 'acceptability and adherence', 'positive mental health']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C1442163', 'cui_str': 'MoM'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",367.0,0.0973773,The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group.,"[{'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Monteiro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17134679']
1259,32616612,Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D.,"OBJECTIVE


To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen.
RESEARCH DESIGN AND METHODS


This was a phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi ( n  = 336) or lispro ( n  = 337) injected 0-2 min prior to meals. Patients could continue metformin and/or a sodium-glucose cotransporter 2 inhibitor. The primary end point was change in HbA 1c  from baseline to 26 weeks (noninferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions during a standardized meal test.
RESULTS


HbA 1c  improved for both URLi and lispro, and noninferiority was confirmed: estimated treatment difference (ETD) 0.06% (95% CI -0.05; 0.16). Mean change in HbA 1c  was -0.38% for URLi and -0.43% for lispro, with an end-of-treatment HbA 1c  of 6.92% and 6.86%, respectively. URLi was superior to lispro in controlling 1- and 2-h PPG excursions: 1-h ETD, -0.66 mmol/L (95% CI -1.01, -0.30); 2-h ETD, -0.96 mmol/L (-1.41, -0.52). Significantly lower PPG excursions were evident from 0.5 to 4.0 h postmeal with URLi treatment. There were no significant treatment differences in rates of severe or documented hypoglycemia (<3.0 mmol/L). Incidence of overall treatment-emergent adverse events was similar between treatments.
CONCLUSIONS


URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA 1c  and superior to lispro for PPG control in patients with type 2 diabetes.",2020,"Mean change in HbA 1c  was -0.38% for URLi and -0.43% for lispro, with an end-of-treatment HbA 1c  of 6.92% and 6.86%, respectively.","['patients with type 2 diabetes on a basal-bolus insulin regimen', 'patients with type 2 diabetes', 'Patients With Type']","['ultra rapid lispro (URLi) versus lispro', 'basal insulin glargine or degludec in combination with prandial lispro treatment', 'metformin and/or a sodium-glucose cotransporter 2 inhibitor', 'Ultra Rapid Lispro With Lispro', 'lispro ( n  = 337) injected 0-2 min prior to meals', 'blinded URLi']","['HbA 1c  improved for both URLi and lispro, and noninferiority', 'Mean change in HbA 1c', 'change in HbA 1c', 'PPG excursions', 'Incidence of overall treatment-emergent adverse events', 'postprandial glucose (PPG) excursions', 'rates of severe or documented hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",337.0,0.148655,"Mean change in HbA 1c  was -0.38% for URLi and -0.43% for lispro, with an end-of-treatment HbA 1c  of 6.92% and 6.86%, respectively.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blevins', 'Affiliation': 'Texas Diabetes & Endocrinology, Austin, TX.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Jinnouchi Hospital, Kumamoto, Japan.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2550']
1260,32618578,Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial.,"BACKGROUND


Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control.
OBJECTIVE


This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA.
METHODS


This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index.
RESULTS


We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes.
CONCLUSIONS


A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323.",2020,The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5).,"['enrolled 51 participants (IG: n=26 and DG: n=25', 'people with knee OA', 'patients with knee OA', 'People With Knee Osteoarthritis']","['12-Week Multifaceted Wearable-Based Program', 'PT counseling', 'physiotherapist (PT)-led counseling intervention', 'multifaceted wearable-based program']","['daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index', 'perceived sitting habit', 'physical activity', 'MVPA', 'MVPA time', 'time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini']","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]",51.0,0.150513,The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5).,"[{'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Feehan', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Shaw', 'Affiliation': 'School of Interactive Art & Technology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gromala', 'Affiliation': 'School of Interactive Art & Technology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Aviña-Zubieta', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Hoens', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Koehn', 'Affiliation': 'Arthritis Consumer Experts, Vancouver, BC, Canada.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Tam', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Therrien', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Townsend', 'Affiliation': 'Division of Health Research, Faculty of Health & Medicine, Lancaster University, Lancashire, United Kingdom.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Noonan', 'Affiliation': 'Mary Pack Arthritis Program, Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Backman', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/19116']
1261,32621141,Outcome and complications of distal tibia fractures treated with intramedullary nails versus minimally invasive plate osteosynthesis and the role of fibula fixation.,"INTRODUCTION


Distal tibia fractures have been managed conservatively as well surgically. A large number of implants have been used for surgical management of these fractures. No treatment method or implant has been proven to be superior to others. In this prospective comparative study, the complications and outcome of distal tibia fractures managed with intramedullary nails and minimally invasive plate osteosynthesis has been compared. Further, the role of fibula fixation in these fractures has been evaluated.
MATERIALS AND METHOD


One hundred and fifty-four patients of distal tibia fractures with concomitant fibula fractures were randomized into 4 treatment groups based on predetermined inclusion criteria. Functional outcome in these groups was compared based on AOFAS score at 1 year. Intra-operative, post-operative parameters as well as radiological alignment, complications and the need for reoperation were also compared in these groups.
RESULT


The functional outcome in all four treatment groups was similar. The duration of surgery and radiation exposure was higher with minimally invasive plate osteosynthesis. There was no improvement in outcome with plating of fibula. However, fixation of fibula improved the rotational alignment in distal tibia fractures.
CONCLUSION


Although there is no difference in outcome of distal tibia fractures with either nailing or minimally invasive plating, nailing is recommended for closed displaced extraarticular fractures. Fixation of fibula should not be done routinely but should be reserved only for a few specific fracture patterns.",2020,"Although there is no difference in outcome of distal tibia fractures with either nailing or minimally invasive plating, nailing is recommended for closed displaced extraarticular fractures.",['One hundred and fifty-four patients of distal tibia fractures with concomitant fibula fractures'],"['intramedullary nails and minimally invasive plate osteosynthesis', 'intramedullary nails versus minimally invasive plate osteosynthesis']","['outcome with plating of fibula', 'distal tibia fractures', 'AOFAS score', 'radiological alignment, complications and the need for reoperation', 'fibula fixation', 'duration of surgery and radiation exposure', 'Outcome and complications of distal tibia fractures']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262488', 'cui_str': 'Fracture of distal end of tibia'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0149699', 'cui_str': 'Fracture of fibula'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0262488', 'cui_str': 'Fracture of distal end of tibia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}]",154.0,0.0127755,"Although there is no difference in outcome of distal tibia fractures with either nailing or minimally invasive plating, nailing is recommended for closed displaced extraarticular fractures.","[{'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Kariya', 'Affiliation': 'Department of Orthopaedics, MGIMS, Sewagram, Wardha, 442 102, India. ankurkariyaorth@gmail.com.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Orthopaedics, MGIMS, Sewagram, Wardha, 442 102, India.'}, {'ForeName': 'Kisan', 'Initials': 'K', 'LastName': 'Patond', 'Affiliation': 'Department of Orthopaedics, MGIMS, Sewagram, Wardha, 442 102, India.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Mundra', 'Affiliation': 'Department of Community Medicine, MGIMS, Sewagram, Wardha, 442 102, India.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02726-y']
1262,32623608,"The MelFo Study UK: Effects of a Reduced-Frequency, Stage-Adjusted Follow-Up Schedule for Cutaneous Melanoma 1B to 2C Patients After 3-Years.","BACKGROUND


Evidence-based guidelines for follow-up treatment of American Joint Committee on Cancer (AJCC) stages 1B to 2C melanoma patients are lacking. The MELanoma FOllow-up study is an international phase 3 randomized trial, and the 3-year interim data were recently reported from the Netherlands. The study was undertaken concurrently with a British cohort for comparison and validation of the Dutch study.
METHODS


The study enrolled and stratified 207 patients by AJCC stage. The conventional schedule group (CSG; n = 103) cohort was reviewed as per UK guidelines. The experimental schedule group (ESG; n = 104) cohort was reviewed in a reduced-frequency nurse-led, consultant-supervised clinic. Quality of life (QoL) was measured at baseline (T1), a 1 year (T2), and at 3 years (T3) using the State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS) of the RAND-36.
RESULTS


Of the 207 QoL questionnaires, 170 (82.1%) were completed at T3. Both cohorts expressed high satisfaction (> 93%) with their regimens. At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols. Recurrence had developed in 33 patients Conventional follow-up (CFU), 16 [15.5%]; Experimental follow-up (EFU), 17 [16.3%]. Self-examination was the method of detection for 12 ESG patients (70.6%) and 11 CSG patients (68.8%). The melanoma-specific survival was identical.
CONCLUSION


The UK 3-year data were consistent with the previous Dutch report. The reduced follow-up strategy was shown to be safe, with significant resource usage benefits for national cancer services. Patient anxiety levels were not increased by a less-intensive follow-up regimen, and acceptance was high. The study data indicate that patient self-examination is very effective for recurrence detection.",2020,"At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols.","['British cohort for comparison and validation of the Dutch study', '207 patients by AJCC stage', 'Cutaneous Melanoma 1B to 2C Patients After 3-Years']","['Reduced-Frequency, Stage-Adjusted Follow-Up Schedule']","['Patient anxiety levels', 'Recurrence', 'State-Trait Anxiety Inventory, the Cancer Worry Scale, the Impact-of-Event Scale, and the Mental and Physical Component scales (PCS/MCS', 'Quality of life (QoL', 'melanoma-specific survival']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",207.0,0.0716703,"At T3, no significant group effect was found on any patient-reported outcome measures scores, indicating no QoL difference between the follow-up protocols.","[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Moncrieff', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK. marc.moncrieff@nnuh.nhs.uk.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Underwood', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Garioch', 'Affiliation': 'Department of Dermatology, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heaton', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Nakul', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Bastiaannet', 'Affiliation': 'Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Josette E H M', 'Initials': 'JEHM', 'LastName': 'Hoekstra-Weebers', 'Affiliation': 'University Medical Center Groningen, Wenckebach Institute, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Harald J', 'Initials': 'HJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Annals of surgical oncology,['10.1245/s10434-020-08758-2']
1263,32407288,Telemonitoring Versus Usual Care for Elderly Patients With Heart Failure Discharged From the Hospital in the United States: Cost-Effectiveness Analysis.,"BACKGROUND


Telemonitoring-guided interventional management reduces the need for hospitalization and mortality of patients with chronic heart failure (CHF).
OBJECTIVE


This study aimed to analyze the cost-effectiveness of usual care with and without telemonitoring-guided management in patients with CHF discharged from the hospital, from the perspective of US health care providers.
METHODS


A lifelong Markov model was designed to estimate outcomes of (1) usual care alone for all postdischarge patients with CHF (New York Heart Association [NYHA] class I-IV), (2) usual care and telemonitoring for all postdischarge patients with CHF, (3) usual care for all postdischarge patients with CHF and telemonitoring for patients with NYHA class III to IV, and (4) usual care for all postdischarge patients with CHF plus telemonitoring for patients with NYHA class II to IV. Model inputs were derived from the literature and public data. Sensitivity analyses were conducted to assess the robustness of model. The primary outcomes were total direct medical cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).
RESULTS


In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs). ICERs of the telemonitoring for NYHA class III to IV group (US $35,393 per QALY) and the telemonitoring for NYHA class II to IV group (US $38,261 per QALY) were lower than the ICER of the universal telemonitoring group (US $100,458 per QALY). One-way sensitivity analysis identified five critical parameters: odds ratio of hospitalization for telemonitoring versus usual care, hazard ratio of all-cause mortality for telemonitoring versus usual care, CHF hospitalization cost and monthly outpatient costs for NYHA class I, and CHF hospitalization cost for NYHA class II. In probabilistic sensitivity analysis, probabilities of the universal telemonitoring, telemonitoring for NYHA class II to IV, telemonitoring for NYHA class III to IV, and universal usual care groups to be accepted as cost-effective at US $50,000 per QALY were 2.76%, 76.31%, 18.6%, and 2.33%, respectively.
CONCLUSIONS


Usual care for all discharged patients with CHF plus telemonitoring-guided management for NYHA class II to IV patients appears to be the preferred cost-effective strategy.",2020,"In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs).","['Elderly Patients With Heart Failure', 'postdischarge patients with CHF (New York Heart Association [NYHA] class I-IV), (2', 'patients with chronic heart failure (CHF', 'patients with CHF discharged from the hospital, from the perspective of US health care providers']","['usual care with and without telemonitoring-guided management', 'usual care and telemonitoring for all postdischarge patients with CHF, (3) usual care for all postdischarge patients with CHF and telemonitoring for patients with NYHA class III to IV, and (4) usual care for all postdischarge patients with CHF plus telemonitoring', 'Telemonitoring Versus Usual Care']","['usual care, CHF hospitalization cost and monthly outpatient costs for NYHA class', 'cost-effectiveness', 'total direct medical cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0172675,"In the base case analysis, universal telemonitoring group gained the highest QALYs (6.2967 QALYs), followed by the telemonitoring for NYHA class II to IV group (6.2960 QALYs), the telemonitoring for NYHA class III to IV group (6.2450 QALYs), and the universal usual care group (6.1530 QALYs).","[{'ForeName': 'Xinchan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, China (Hong Kong).'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, China (Hong Kong).'}, {'ForeName': 'Joyce Hs', 'Initials': 'JH', 'LastName': 'You', 'Affiliation': 'School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, NT, China (Hong Kong).'}]",JMIR mHealth and uHealth,['10.2196/17846']
1264,32634815,Comparison of Circulating Levels of Uremic Toxins in Hemodialysis Patients Treated with Medium Cut-Off Membranes and High-Flux Membranes: Theranova in Sisli Hamidiye Etfal (THE SHE) Randomized Control Study.,"INTRODUCTION


Removal of uremic toxins is a main objective of hemodialysis; however, whether high-flux and medium cut-off (MCO) membranes differ as regards removal of middle and large uremic toxins is not clear.
OBJECTIVE


To compare medium cut-off and high-flux dialyzers as regards their intra- and interdialysis effect on circulating levels of middle and large uremic toxins and serum albumin.
METHODS


Fifty-two patients were randomized to have hemodialysis with either 3 months of high-flux dialyzer followed by 3 months of MCO or vice versa. Blood samples were taken before and after dialysis at the first and last sessions of each dialyzer for analyses of middle and large uremic toxins including inflammatory mediators and vascular endothelial growth factor (VEGF), and serum albumin.
RESULTS


Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all). Last session predialysis levels of β-2 microglobulin, free kappa light chain, and free lambda light chain were lower than first session predialysis levels in MCO dialyzers as compared to high-flux dialyzers (p < 0.05 for all). Last session levels of interleukin-6, interleukin-10, interleukin-17, and interferon-gamma did not differ between dialyzers (p > 0.05 for all). VEGF level was lower in the MCO group compared to the high-flux group (p = 0.043). Last session level of serum albumin with MCO dialyzers was lower than that with high-flux dialyzers (3.62 [3.45-3.88] vs. 3.78 [3.58-4.02] g/L) (p = 0.04) and 6.7% lower (p < 0.001) than at the first session of MCO dialyzers.
CONCLUSION


The decline in circulating levels of several middle and large uremic toxins including VEGF following hemodialysis was more pronounced when using MCO membranes as compared to high-flux membranes while their effect on inflammatory molecules was similar.",2020,"RESULTS


Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all).","['Hemodialysis Patients Treated with Medium Cut-Off Membranes and High-Flux Membranes: Theranova in Sisli Hamidiye Etfal (THE SHE', 'Fifty-two patients']","['high-flux dialyzer followed by 3 months of MCO or vice versa', 'MCO', 'medium cut-off and high-flux dialyzers']","['inflammatory mediators and vascular endothelial growth factor (VEGF), and serum albumin', 'interleukin-6, interleukin-10, interleukin-17, and interferon-gamma', 'VEGF level', 'β-2 microglobulin, free kappa light chain, and free lambda light chain', 'Last session level of serum albumin with MCO dialyzers', 'postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319570', 'cui_str': '52'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443743', 'cui_str': 'Free kappa light chain'}, {'cui': 'C0443744', 'cui_str': 'Free lambda light chain'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0021037', 'cui_str': 'Immunoglobulin, L chain, lambda'}]",52.0,0.019657,"RESULTS


Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kappa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all).","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sevinc', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nuri Baris', 'Initials': 'NB', 'LastName': 'Hasbal', 'Affiliation': 'Nephrology Department, Hakkari State Hospital, Hakkari, Turkey.'}, {'ForeName': 'Vuslat', 'Initials': 'V', 'LastName': 'Yilmaz', 'Affiliation': 'Neuroscience Department, Aziz Sancar Institute of Experimental Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Taner', 'Initials': 'T', 'LastName': 'Basturk', 'Affiliation': 'Nephrology Department, University of Health Sciences, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey, tanerbast@yahoo.com.'}, {'ForeName': 'Elbis', 'Initials': 'E', 'LastName': 'Ahbap', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Sakaci', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Perin Nazif', 'Initials': 'PN', 'LastName': 'Ozcafer', 'Affiliation': 'Nephrology Department, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Abdulkadir', 'Initials': 'A', 'LastName': 'Unsal', 'Affiliation': 'Nephrology Department, University of Health Sciences, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Blood purification,['10.1159/000508061']
1265,32634820,Serial assessment of fat and fat-free mass accretion in very preterm infants: a randomized trial.,"BACKGROUND


Clinicians could modify dietary interventions during early infancy by monitoring fat and fat-free mass accretion in very preterm infants.
METHODS


Preterm infants were randomly assigned to either having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group). All infants underwent serial assessments of body composition by air-displacement plethysmography before 32 weeks of postmenstrual age (PMA) and at 36 weeks PMA. The primary outcome was percent body fat (%BF) at 3 months of corrected age (CA).
RESULTS


Fifty infants were randomized (median gestational age: 30 weeks; mean ± SD birth weight: 1387 ± 283 g). The mean %BF increased from 7 ± 4 before 32 weeks PMA to 20 ± 5 at 3 months CA. The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4). Feeding practices and anthropometric measurements during hospitalization did not differ between groups.
CONCLUSIONS


Serial assessments of body composition in both intervention and control groups showed consistent increments in %BF. However, providing this information to clinicians did not influence nutritional practices or growth.
IMPACT


Serial assessments of body composition in preterm infants at 32 and 36 weeks postmenstrual age show consistent increments in % body fat up to 3 months of corrected age. However, providing this information to the clinician did not influence nutritional practices or growth.",2020,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"['very preterm infants', 'Fifty infants were randomized (median gestational age: 30 weeks; mean\u2009±\u2009SD birth weight: 1387\u2009±\u2009283\u2009g', 'Preterm infants', 'preterm infants at 32 and 36 weeks postmenstrual age']","['Serial assessment of fat and fat-free mass accretion', 'having reports on infant body composition available to the clinicians caring for them (intervention group) or not having reports available (control group']","['body composition', 'mean %BF', 'percent body fat (%BF']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",50.0,0.0677656,The differences in mean %BF between the intervention group and the control group were not statistically significant at 36 weeks PMA (14.5 vs. 13.6) or 3 months CA (20.8 vs. 19.4).,"[{'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA. asalas@peds.uab.edu.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Jerome', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Chandler-Laney', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, 35249, USA.'}]",Pediatric research,['10.1038/s41390-020-1052-x']
1266,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1267,32603994,A randomized-controlled examination of the effect of cognitive reappraisal instruction on maternal accommodation of child anxiety symptoms.,"Parental accommodation plays a key role in the maintenance of child anxiety, yet much of the research to date has been correlational, making it difficult to draw conclusions about underlying mechanisms. Given preliminary evidence that parental beliefs play a role in parental accommodation, the present study sought to experimentally reduce accommodation by targeting parental attitudes about child anxiety. Mothers of children ages 4-9 (N = 47) were randomly assigned to either receive brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON). At pre- and post-intervention mothers were presented with bogus information that their child was experiencing varying levels of distress while completing a task in a nearby room. Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress were measured pre- and post-intervention. EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers. EXP and CON mothers showed similar changes in negative affect. Findings from this study provide preliminary experimental evidence that targeting maternal beliefs about child anxiety can result in changes in maternal distress and behavior following exposure to child distress. Implications for prevention and treatment are discussed.",2020,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.",['Mothers of children ages 4-9 (N = 47'],"['cognitive reappraisal instruction', 'brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON']","['distress and perceived likelihood of accommodation', 'Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress', 'maternal accommodation of child anxiety symptoms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",47.0,0.050831,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Department of Psychology, Florida International University, 11200 SW 8th Street, Miami, FL, 33199, United States.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102260']
1268,32609523,Effectiveness of Resistive Vibration Exercise and Whey Protein Supplementation Plus Alkaline Salt on the Skeletal Muscle Proteome Following 21 Days of Bed Rest in Healthy Males.,"Muscle atrophy is a deleterious consequence of physical inactivity and is associated with increased morbidity and mortality. The aim of this study was to decipher the mechanisms involved in disuse muscle atrophy in eight healthy men using a 21 day bed rest with a cross-over design (control, with resistive vibration exercise (RVE), or RVE combined with whey protein supplementation and an alkaline salt (NEX)). The main physiological findings show a significant reduction in whole-body fat-free mass (CON -4.1%, RVE -4.3%, NEX -2.7%,  p  < 0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%,  p  < 0.05), and maximal voluntary contraction (CON -15%, RVE -12%, and NEX -9.5%,  p  < 0.05) and a reduction in mitochondrial enzyme activity (CON -30.7%, RVE -31.3%, NEX -17%,  p  < 0.05). The benefits of nutrition and exercise countermeasure were evident with an increase in leg lean mass (CON -1.7%, RVE +8.9%, NEX +15%,  p  < 0.05). Changes to the vastus lateralis muscle proteome were characterized using mass spectrometry-based label-free quantitative proteomics, the findings of which suggest alterations to cell metabolism, mitochondrial metabolism, protein synthesis, and degradation pathways during bed rest. The observed changes were partially mitigated during RVE, but there were no significant pathway changes during the NEX trial. The mass spectrometry proteomics data have been deposited to the ProteomeXchange Consortium with the dataset identifier PXD006882. In conclusion, resistive vibration exercise, when combined with whey/alkalizing salt supplementation, could be an effective strategy to prevent skeletal muscle protein changes, muscle atrophy, and insulin sensitivity during medium duration bed rest.",2020,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","['21 days of bedrest in healthy males', '8 healthy men using']","['resistive vibration exercise', '21-day bed rest with a cross-over design (control, with resistive vibration exercise (RVE) or RVE combined with whey protein supplementation and an alkaline salt (NEX', 'resistive vibration exercise and whey protein supplementation plus alkaline salt']","['whole body fat free mass', 'mitochondrial enzyme activity', 'maximal voluntary contraction ', 'morbidity and mortality', 'maximal oxygen consumption', 'leg lean mass']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",8.0,0.031534,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Kenny', 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Tascher', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ziemianin', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}, {'ForeName': 'Floriane', 'Initials': 'F', 'LastName': 'Rudwill', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Zahariev', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chery', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Gauquelin-Koch', 'Affiliation': ""Centre National d'Etudes Spatiales (CNES), Paris 75001, France.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Barielle', 'Affiliation': 'Institut de Médecine et de Physiologie Spatiales, Toulouse 31400, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heer', 'Affiliation': 'Profil, Hellersbergstrasse 9, Neuss D-41460, Germany.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Blanc', 'Affiliation': ""Départment d'Ecologie, Physiologie et Ethologie, Université de Strasbourg, Institut Pluridisiplinaire Hubert Curien. CNRS, UMR 7178, Strasbourg 67087, France.""}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': ""O'Gorman"", 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bertile', 'Affiliation': 'Département Sciences Analytiques, Université de Strasbourg, CNRS, IPHC UMR 7178, F-67000 Strasbourg 67087, France.'}]",Journal of proteome research,['10.1021/acs.jproteome.0c00256']
1269,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
1270,32624244,"Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results.","PURPOSE


To examine the 36-month efficacy and safety of a 0.2 μg/day fluocinolone acetonide insert (FAi) to treat noninfectious uveitis of the posterior segment (NIU-PS).
DESIGN


Phase 3, prospective, double-masked, multicenter study (clinicaltrials.gov, NCT01694186).
PARTICIPANTS


Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids.
METHODS


Participants were randomized 2:1 to FAi or sham (injection plus standard of care) treatment.
MAIN OUTCOME MEASURES


The primary outcome was the difference between the proportion of FAi-treated and sham-treated patients who had a uveitis recurrence. Secondary outcomes included time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments.
RESULTS


One hundred twenty-nine participants (n = 87 FAi-treated; n = 42 sham-treated) were enrolled. Over 36 months of treatment, cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P < 0.001); time to first recurrence was commensurately longer (median 657.0 and 70.5 days, respectively; P < 0.001). The number of recurrences per eye was significantly lower in the FAi-treated compared with the sham-treated group (mean 1.7 vs. 5.3, respectively, P < 0.001). At 36 months, more FAi-treated eyes had a ≥15-letter increase in BCVA from baseline and fewer FAi-treated eyes had investigator-determined macular edema at month 36 compared with sham-treated eyes (33.3% vs. 14.7% and 13.0% vs. 27.3% for BCVA and macular edema, respectively). Fewer FAi compared with sham-treated participants required adjunctive treatments (57.5% vs. 97.6%, respectively). Intraocular pressure (IOP) was similar for both study groups at month 36 (mean ± standard deviation 14.5±5.1 and 14.8±5.3, respectively), and approximately half as many eyes in the FAi-treated group when compared with the sham-treated group underwent IOP-lowering surgery (5.7% vs. 11.9%). Cataract surgery was required more frequently over 36 months in the FAi-treated compared with the sham-treated group (73.8% vs. 23.8% of eyes, respectively).
CONCLUSIONS


Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.",2020,"Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.","['One hundred twenty-nine participants (n\xa0= 87', 'Participants', 'Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids', 'FAi-treated; n\xa0= 42 sham-treated) were enrolled']","['Fluocinolone acetonide', 'FAi or sham (injection plus standard of care) treatment', 'fluocinolone acetonide insert (FAi', 'Fluocinolone Acetonide', 'FAi']","['time to first recurrence', 'Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis', 'time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments', 'macular edema', 'uveitis recurrence', 'cumulative uveitis recurrences', 'number of recurrences per eye', 'BCVA', 'Intraocular pressure (IOP', 'recurrence-free durations, fewer recurrence episodes', 'uveitis recurrence rates', '36-month efficacy and safety', 'Cataract surgery']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]",129.0,0.488521,"Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.","[{'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University Eye Center, Duke University, Durham, North Carolina. Electronic address: jaffe001@mc.duke.edu.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Pavesio', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.04.001']
1271,32639369,Individuals with chronic pain have the same response to placebo analgesia as healthy controls in terms of magnitude and reproducibility.,"It is unclear whether a diagnosis of chronic pain is associated with an increase or decrease in the placebo response. The aim of this study was to use an experimental placebo conditioning paradigm to test whether expectancy for pain relief impacts on acute pain perception in individuals with a chronic pain diagnosis of osteoarthritis (OA) or fibromyalgia (FM), compared to healthy individuals (HIs). An inert cream was applied to the dominant forearm of participants (60 OA, 79 FM, and 98 HI), randomly assigned to either a placebo or control group. In both groups, an inactive cream was applied to the dominant forearm. The placebo group was told this may or may not be a local anaesthetic cream, whereas the control group was told the cream was inactive. Laser pain was delivered, and numerical pain intensity ratings collected before, during, and after cream application, along with expectation of pain relief and anxiety. The procedure was repeated 2 weeks later to assess reproducibility. There was a significant reduction in pain in the placebo group, independent of clinical diagnosis. Diagnostic groups (OA, FM, and HI) did not differ in their magnitude of placebo analgesia or expectancy of pain relief. The results were similar in the repeat session. The results demonstrate that individuals with chronic pain respond to experimental placebo analgesia in a similar and reproducible manner as HIs, despite higher levels of psychological comorbidity. This has implications for using placebo analgesia in the treatment of chronic pain.",2020,"Diagnostic groups (OA,FM,HI) did not differ in their magnitude of placebo analgesia or expectancy of pain relief.","['Individuals with chronic pain', 'individuals with chronic pain', 'individuals with a chronic pain diagnosis of osteoarthritis (OA) or fibromyalgia (FM), compared to healthy individuals (HI', 'chronic pain']","['placebo or control group', 'placebo analgesia', 'placebo']","['pain relief and anxiety', 'pain relief', 'Laser pain', 'psychological co-morbidity', 'acute pain perception', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.257629,"Diagnostic groups (OA,FM,HI) did not differ in their magnitude of placebo analgesia or expectancy of pain relief.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Power', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Christopher Andrew', 'Initials': 'CA', 'LastName': 'Brown', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sivan', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lenton', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Rainey', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'El-Deredy', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Anthony Kenneth Peter', 'Initials': 'AKP', 'LastName': 'Jones', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001966']
1272,32609805,Evaluation of a Safety Awareness Group Program for Adults With Intellectual Disability.,"Using a participatory research approach, we enlisted 12 U.S. Centers for Independent Living (CILs) to recruit and enroll 170 adults with intellectual disability (ID) to be randomized to either The Safety Class, an abuse prevention group program, or usual care. Participants were asked to complete pre, post, and 3-month follow-up questionnaires. CIL staff members facilitated the eight-session, interactive program. Quantitative and qualitative findings suggest that participation in a brief safety program may improve safety protective factors among men and women with ID. The Safety Class serves as one model for delivering an abuse prevention and education intervention to adults with significant safety needs but extremely limited access to relevant community resources.",2020,Quantitative and qualitative findings suggest that participation in a brief safety program may improve safety protective factors among men and women with ID.,"['enlisted 12 U.S. Centers for Independent Living (CILs) to recruit and enroll 170 adults with intellectual disability (ID', 'Adults With Intellectual Disability', 'men and women with ID']","['Safety Class, an abuse prevention group program, or usual care']",['safety protective factors'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}]",170.0,0.028335,Quantitative and qualitative findings suggest that participation in a brief safety program may improve safety protective factors among men and women with ID.,"[{'ForeName': 'Rosemary B', 'Initials': 'RB', 'LastName': 'Hughes', 'Affiliation': 'University of Montana.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Robinson-Whelen', 'Affiliation': 'Baylor College of Medicine and TIRR Memorial Hermann.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Davis', 'Affiliation': 'Criminal Justice Initiatives of The Arc.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Meadours', 'Affiliation': 'League of Self Advocates.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Kincaid', 'Affiliation': 'Ravalli People First.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Ravalli People First.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Millin', 'Affiliation': 'Summit Independent Living Center.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'SAFE - Disability Services.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'McDonald', 'Affiliation': 'Syracuse University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal on intellectual and developmental disabilities,['10.1352/1944-7558-125.4.304']
1273,32610511,Acute Effects of Open Kinetic Chain Exercise Versus Those of Closed Kinetic Chain Exercise on Quadriceps Muscle Thickness in Healthy Adults.,"This study aimed to compare immediate changes in the thickness of the rectus femoris (RF), vastus intermedius (VI), vastus lateralis (VL), vastus medialis (VM), and vastus medialis oblique (VMO) muscles after open kinetic chain exercise (OKCE) and closed kinetic chain exercise (CKCE) and identify the effect of both exercise types on each quadricep muscle for early rehabilitation to prevent knee joint injury. Twenty-six healthy participants (13 males and 13 females) were randomly divided into the OKCE ( n  = 13) and CKCE ( n  = 13) groups. The thickness of their quadriceps muscles was measured using a portable ultrasonic imaging device before and after exercise in the sequence RF, VI, VL, VM, and VMO. A two-way repeated measures analysis of variance was used to compare the thickness of each component of the quadriceps muscles between the two groups. The thickness of the RF, VL, VM, and VMO muscles increased after OKCE, and the thickness of the VI muscle showed the greatest increase with a medium-large effect size (F = 8.52,  p  = 0.01, and d = 0.53). The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71,  p  = 0.00, and d = 1.02). These results indicate that the thickness of the quadriceps muscles can be selectively improved depending on the type of exercise.",2020,"The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71,  p  = 0.00, and d = 1.02).","['Twenty-six healthy participants (13 males and 13 females', 'Healthy Adults']","['Open Kinetic Chain Exercise Versus', 'Closed Kinetic Chain Exercise', 'OKCE', 'CKCE', 'open kinetic chain exercise (OKCE) and closed kinetic chain exercise (CKCE']","['thickness of the RF, VL, VM, and VMO muscles', 'thickness of their quadriceps muscles', 'rectus femoris (RF), vastus intermedius (VI), vastus lateralis (VL), vastus medialis (VM), and vastus medialis oblique (VMO) muscles', 'thickness of the VI, VL, VM, and VMO muscles', 'Quadriceps Muscle Thickness']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0454289', 'cui_str': 'Open kinetic chain exercises'}, {'cui': 'C0454288', 'cui_str': 'Closed kinetic chain exercises'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224448', 'cui_str': 'Structure of vastus intermedius muscle'}]",26.0,0.0226761,"The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71,  p  = 0.00, and d = 1.02).","[{'ForeName': 'Soul', 'Initials': 'S', 'LastName': 'Cheon', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}, {'ForeName': 'Joo-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}, {'ForeName': 'Hyung-Pil', 'Initials': 'HP', 'LastName': 'Jun', 'Affiliation': 'Department of Physical Education, Dong-A University, Busan 49236, Korea.'}, {'ForeName': 'Yong Woo', 'Initials': 'YW', 'LastName': 'An', 'Affiliation': 'Department of Health and Human Sciences, Loyola Marymount University, Los Angeles, CA 90045, USA.'}, {'ForeName': 'Eunwook', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134669']
1274,32610568,The Acute Impact of External Compression on Back Squat Performance in Competitive Athletes.,"The aim of the present study was to evaluate the effects of external compression with blood flow restriction on power output and bar velocity changes during the back-squat exercise (SQ). The study included 10 judo athletes (age = 28.4 ± 5.8 years; body mass = 81.3 ± 13.1 kg; SQ one-repetition maximum (1-RM) 152 ± 34 kg; training experience 10.7 ± 2.3 years).
METHODS


The experiment was performed following a randomized crossover design, where each participant performed three different exercise protocols: (1) control, without external compression (CONT); (2) intermittent external compression with pressure of 100% arterial occlusion pressure (AOP) (EC-100); and (3) intermittent external compression with pressure of 150% AOP (EC-150). To assess the differences between conditions, the participants performed 3 sets of 3 repetitions of the SQ at 70% 1-RM. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the three conditions were examined using repeated measures two-way ANOVA.
RESULTS


The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p  = 0.03), PV ( p  = 0.02), MP ( p  = 0.04), and MV ( p  = 0.03), for the EC-150, compared to the CONT. Furthermore, a statistically significant increase in PP ( p  = 0.04), PV ( p  = 0.03), MP ( p  = 0.02), and MV ( p  = 0.01) were observed for the EC-150 compared to EC-100. There were no significant changes in PP, PV, MP, and MV, between EC-100 and CONT conditions.
CONCLUSION


The results indicate that the use of extremely high-pressure external compression (150% AOP) during high-loaded (70% 1-RM) lower limb resistance exercise elicits an acute increase in power output and bar velocity.",2020,"The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p  = 0.03),","['10 judo athletes (age = 28.4 ± 5.8 years; body mass = 81.3 ± 13.1 kg', 'Competitive Athletes']","['exercise protocols: (1) control, without external compression (CONT); (2) intermittent external compression with pressure of 100% arterial occlusion pressure (AOP) (EC-100); and (3) intermittent external compression with pressure of 150% AOP (EC-150', 'external compression with blood flow restriction', 'back-squat exercise (SQ', 'External Compression']","['PP', 'PV', 'PP, PV, MP, and MV, between EC-100 and CONT conditions', 'power output and bar velocity changes', 'power output and bar velocity', 'peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV', 'Back Squat Performance']","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",10.0,0.0501652,"The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p  = 0.03),","[{'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kostrzewa', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Jarosz', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Trybulski', 'Affiliation': 'Department of Medical Sciences, The Wojciech Korfanty School of Economics, 40-065 Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17134674']
1275,32615145,Does connectedness to nature improve the eating behaviours of pre-schoolers? Emerging evidence from the Play&Grow randomised controlled trial in Hong Kong.,"BACKGROUND


Nature-based interventions, which focus on outdoor play, mental health, and self-directed autonomous play, are becoming popular in promoting well-being. The objective of this study was to test whether connecting to nature would contribute to better feeding and eating habits in families with pre-schoolers.
METHODS


241 families with children aged two to five were randomly assigned to the Intervention (IG) and Control Groups (CG). IG received 10 sessions of a family-based programme, which included a novel Connectedness to Nature (CN) element. CG received only the government's health recommendations. The effectiveness of the intervention's primary outcomes (CN, eating/feeding behaviours) was analysed by a repeated measures structural equation model with intervention status as a causal predictor.
RESULTS


204 families (IG, n = 120; CG, n = 84) completed the measurements before and after the trial. The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)). In the IG, children's CN strongly predicted caregivers' feeding style (β = 0.48 (p < .01, 95%CI = 0.14, 0.83)) and moderately, children's eating behaviours (β = 0.21 (p = .16, 95%CI = -0.09, 0.52)). This produced a positive trend for greater vegetable consumption in the IG compared to the CG (β = 0.20 (95%CI = 0.01, 0.39) vs. β = -0.05, (95%CI = -0.18, 0.08)). Interestingly, the path values in the CG significantly reflected the traditional pattern, (e.g., parental feeding style strongly influenced children's eating behaviour (β = 0.33, p = .001, 95%CI = 0.13, 0.54).
CONCLUSIONS


The Play&Grow intervention positively increased caregivers' and children's CN. It also improved eating behaviors in children independent of their caregivers' feeding style. This may indicate a higher degree of autonomy in children's eating behaviour if they are exposed to nature. Further research should test the CN component in promotion of healthy eating in pre-schoolers.",2020,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","['241 families with children aged two to five', '204 families (IG n\u202f=\u202f120, CG n\u202f=\u202f84']","['Intervention (IG) and Control Groups (CG', 'Play&Grow intervention']","[""children's eating behaviours"", 'vegetable consumption', 'feeding and eating habits', ""caregivers' feeding style"", ""caregivers' and children's CN"", ""children's eating behaviour"", 'eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0349590', 'cui_str': 'Nature'}]",241.0,0.128134,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sobko', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong. Electronic address: tsobko@hku.hk.'}, {'ForeName': 'Gavin T L', 'Initials': 'GTL', 'LastName': 'Brown', 'Affiliation': 'Quantitative Data Analysis and Research Unit, Faculty of Education & Social Work, The University of Auckland, New Zealand.'}, {'ForeName': 'Will H G', 'Initials': 'WHG', 'LastName': 'Cheng', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong.'}]",Appetite,['10.1016/j.appet.2020.104781']
1276,32618875,Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? A randomised controlled trial.,"Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at 3 centres in the United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at 6-month follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG = 54, NTG = 51). Mean numerical rating scale pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6 months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% confidence interval [CI]: -1.2 to 0.9, P = 0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. Spinal cord stimulation screening trial had a sensitivity of 100% (95% CI: 78-100) and specificity of 8% (95% CI: 1-25). The mean incremental cost-effectiveness ratio of TG vs NTG was £78,895 per additional quality-adjusted life-year gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening TG provides superior patient outcomes or is cost-effective compared to a no trial screening approach.",2020,SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25).,"['Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51', 'patients with chronic pain of neuropathic origin']","['SCS screening trial strategy (TG) or no trial screening strategy (NTG', 'Spinal cord stimulation (SCS', 'TG and NTG']","['mean incremental cost-effectiveness ratio of TG', 'numerical rating scale (NRS) pain', 'Mean NRS pain']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",105.0,0.379353,SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25).,"[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Rui V', 'Initials': 'RV', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gulve', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomson', 'Affiliation': 'Department of Anaesthesia, Basildon and Thurrock University Hospitals, Basildon, United Kingdom.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Baranidharan', 'Affiliation': 'Leeds Neuromodulation Centre, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Houten', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Harbinder', 'Initials': 'H', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Medical School, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Chadwick', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, United Kingdom.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Brookes', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Earle', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001977']
1277,32629446,Phase III Randomized Study of Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy in Squamous Cell Carcinoma of Head and Neck: The INTERCEPTOR-GONO Study (NCT00999700).,"OBJECTIVES


Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study.
PATIENTS AND METHODS


Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed.
RESULTS


236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B (p = 0.0008).
CONCLUSION


The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.",2020,OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms.,"['236/282 patients were evaluable', 'Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible', 'Squamous Cell Carcinoma of Head and Neck']","['cisplatin/RT (CRT', 'cetuximab and RT (IBRT', 'IBRT and CRT', 'Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy', 'cetuximab-RT']","['body weight loss', 'efficacy, activity and toxicity', 'OS', 'Neutropenia and skin toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",,0.0219668,OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms.,"[{'ForeName': 'Marco Carlo', 'Initials': 'MC', 'LastName': 'Merlano', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy.'}, {'ForeName': 'Nerina', 'Initials': 'N', 'LastName': 'Denaro', 'Affiliation': 'Medical Oncology, St. Croce & Carle University Teaching Hospital and ARCO Foundation, Cuneo, Italy, nerinadenaro@hotmail.com.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Vecchio', 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Curcio', 'Affiliation': 'Trials Office, Medical Oncology, St. Croce & Carle University Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, San Paolo General Hospital, Savona, Italy.'}, {'ForeName': 'Almalina', 'Initials': 'A', 'LastName': 'Bagicalupo', 'Affiliation': 'Radiation Oncology, San Martino Hospital, Genova, Italy.'}, {'ForeName': 'Gianmauro', 'Initials': 'G', 'LastName': 'Numico', 'Affiliation': 'Medical Oncology, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Elvio', 'Initials': 'E', 'LastName': 'Russi', 'Affiliation': 'Radiation Oncology, St. Croce & Carle University Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': ""Corvo'"", 'Affiliation': 'Medical Oncology, IRCCS San Martino, IST National Cancer Institute and University of Genova, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Statistic Unit, Genova University, Genova, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oncology,['10.1159/000507733']
1278,32635281,"Influence of an Aquatic Therapy Program on Perceived Pain, Stress, and Quality of Life in Chronic Stroke Patients: A Randomized Trial.","Pain and depressive states may have a negative impact on the quality of life of individuals with stroke. The aim of this study was to evaluate the effects of a program of Ai Chi aquatic therapy on pain, depression, and quality of life in a sample of people with stroke. Forty-five participants received physiotherapy treatment on dry land (control group), an experimental group received aquatic Ai Chi therapy, and a combined therapy group received alternating sessions of physiotherapy on dry land and aquatic Ai Chi therapy. The Visual Analog Scale (VAS) scale for pain, the resilience scale, and the SF-36 quality of life scale were used as outcome measures. Statistically significant differences were found in the experimental group and the combined intervention group for post treatment pain and resilience ( p  < 0.001). Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001). In conclusion, physical exercise performed in water has positive effects on several factors that contribute towards improving the mood and quality of life of people with acquired brain injury.",2020,"Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001).","['Chronic Stroke Patients', 'people with stroke']","['Aquatic Therapy Program', 'physiotherapy treatment on dry land (control group), an experimental group received aquatic Ai Chi therapy, and a combined therapy group received alternating sessions of physiotherapy on dry land and aquatic Ai Chi therapy', 'Ai Chi aquatic therapy', 'physical exercise']","['general health, vitality, and social function', 'Perceived Pain, Stress, and Quality of Life', 'Pain and depressive states', 'mood and quality of life', 'Visual Analog Scale (VAS) scale for pain, the resilience scale, and the SF-36 quality of life scale', 'pain, depression, and quality of life']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",45.0,0.0453378,"Concerning the SF-36, statistically significant changes ( p  < 0.01) were found in the experimental group and the combined therapy group for all items except general health, vitality, and social function, where no between group differences were observed ( p  = 0.001).","[{'ForeName': 'Sagrario', 'Initials': 'S', 'LastName': 'Pérez-de la Cruz', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, La Cañada de San Urbano, 04120 Almería, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17134796']
1279,32635352,Everyday Pedelec Use and Its Effect on Meeting Physical Activity Guidelines.,"Pedelecs (e-bikes with electrical support up to 25 km·h -1 ) are important in active transportation. Yet, little is known about physiological responses during their everyday use. We compared daily pedelec (P) and bicycle (B) use to determine if pedelecs are a suitable tool to enhance physical activity. In 101 employees, cycling duration and intensity, heart rate (HR) during P and B were recorded via a smartphone app. Each recording period was a randomized crossover design and lasted two weeks. The ride quantity was higher in P compared to B (5.3 ± 4.3 vs. 3.2 ± 4.0 rides·wk -1 ;  p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ± 109 min·wk -1 ;  p  < 0.001). The mean HR during P was lower than B (109 ± 14 vs. 118 ± 17 bpm;  p  < 0.001). The perceived exertion was lower in P (11.7 ± 1.8 vs. 12.8 ± 2.1 in B;  p  < 0.001). The weekly energy expenditure was higher during P than B (717 ± 652 vs. 486 ± 557 metabolic equivalents of the task [MET]·min·wk -1 ;  p  < 0.01). Due to a sufficient HR increase in P, pedelecs offer a more active form of transportation to enhance physical activity.",2020,p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ±,[],[],"['total cycling time', 'weekly energy expenditure', 'ride quantity', 'perceived exertion', 'cycling duration and intensity, heart rate (HR', 'mean HR during P']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0676234,p  < 0.001) resulting in a higher total cycling time per week for P (174 ± 146 min·wk -1 ) compared to B (99 ±,"[{'ForeName': 'Hedwig T', 'Initials': 'HT', 'LastName': 'Stenner', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Boyen', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Protte', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Momme', 'Initials': 'M', 'LastName': 'Kück', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Finkel', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Hanke', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institute of Sports Medicine, Hannover Medical School, 30625 Hanover, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17134807']
1280,32648983,Ketamine mouthwash versus placebo in the treatment of severe oral mucositis pain in children with cancer: A randomized double-blind placebo-controlled trial.,"BACKGROUND AND AIMS


Oral mucositis (OM) is a common and distressing toxicity in children on chemotherapy. There are a limited number of safe and effective therapeutic options available for OM. Ketamine oral rinse has shown promising results in a few studies in adults. This randomized, double-blind placebo-controlled trial aimed to test the efficacy of ketamine mouthwash in reducing chemotherapy-induced severe OM pain in children.
METHODS


Children aged 8-18 years with severe OM were randomized to a single dose of ketamine mouthwash (4 mg/mL solution; dose 1 mg/kg) or a placebo. A sample size of 44 patients was determined. Pain score (6-point faces scale) was noted at baseline and 15, 30, 45, 60, 120, 180, and 240 min. The outcome variables were a reduction in pain score, need for rescue medications, and adverse events.
RESULTS


The baseline characteristics were comparable in the two groups. The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (P = 0.425), with a group difference of 0.32 points. Rescue pain medication (at 60 min) was required in 13.6% in the ketamine group and 18.2% in the placebo group (P = 1.000). No significant adverse events were observed.
CONCLUSIONS


Among children on cancer chemotherapy with severe OM, ketamine mouthwash at a dose of 1 mg/kg did not significantly reduce OM pain. It did not decrease the need for rescue pain medications. Further research is warranted to test higher doses of ketamine for a clinically significant effect.",2020,"The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (P = 0.425), with a group difference of 0.32 points.","['children with cancer', 'children on chemotherapy', 'Children aged 8-18 years with severe OM', 'children']","['Ketamine oral rinse', 'ketamine mouthwash (4\xa0mg/mL solution; dose 1\xa0mg/kg) or a placebo', 'ketamine', 'Ketamine mouthwash versus placebo', 'ketamine mouthwash', 'placebo']","['mean OM pain', 'Pain score (6-point faces scale', 'reduction in pain score, need for rescue medications, and adverse events', 'rescue pain medications', 'severe oral mucositis pain', 'adverse events', 'severe OM pain', 'Rescue pain medication', 'OM pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.776638,"The mean OM pain at 60 min decreased by 1.64 points (CI 1.13-2.14) in the ketamine group and 1.32 points (CI 0.76-1.87) in the placebo group (P = 0.425), with a group difference of 0.32 points.","[{'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Prakash', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jagdish Prasad', 'Initials': 'JP', 'LastName': 'Meena', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Aditya Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Medical Oncology, Dr. B.R.A. IRCH, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Thirumurthy', 'Initials': 'T', 'LastName': 'Velpandian', 'Affiliation': 'Ocular Pharmacology and Pharmacy Division, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Seth', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Pediatric blood & cancer,['10.1002/pbc.28573']
1281,32649015,"Acceptability and feasibility of a parent-targeted dietary intervention in young survivors of childhood cancer: ""Reboot"".","BACKGROUND


Assess the acceptability and feasibility of delivering Reboot, a telephone dietary intervention to parents of pediatric cancer survivors. The research question asks whether tailored dietary support is acceptable and feasible to deliver to parents of young cancer survivors who have recently completed cancer treatment?
PROCEDURE


Pre-post study. Nineteen parents of pediatric cancer survivors (aged 2-13 years) in remission, who had received cancer treatment at a tertiary children's hospital, less than 5 years prior to the intervention. Participants received four weekly 45-min telephone sessions led by a psychologist or dietitian and one postintervention booster session 6 weeks later. Sessions addressed strategies to increase children's vegetable and fruit intake.
RESULTS


Of the 19 parents who started the intervention, 14 completed all sessions within 8 weeks and 12 completed the booster session within 10 weeks. The mean session duration was 47 min. All participants reported that Reboot increased their confidence and knowledge about promoting healthy eating habits to their child.
CONCLUSIONS


Reboot is an acceptable intervention in young cancer survivors aimed at increasing vegetable and fruit intake after cancer treatment.
IMPLICATIONS FOR CANCER SURVIVORS


The results from the Reboot pilot provides preliminary evidence that a targeted intervention to improve the diets of childhood cancer survivors may be feasible with future modification.",2020,"RESULTS


Of the 19 parents who started the intervention","['young survivors of childhood cancer', 'parents of pediatric cancer survivors', ""Nineteen parents of pediatric cancer survivors (aged 2-13\xa0years) in remission, who had received cancer treatment at a tertiary children's hospital, less than 5\xa0years prior to the intervention"", 'young cancer survivors', 'FOR CANCER SURVIVORS', 'childhood cancer survivors', '19 parents who started the intervention', 'parents of young cancer survivors who have recently completed cancer treatment']","['parent-targeted dietary intervention', 'telephone dietary intervention', '45-min telephone sessions led by a psychologist or dietitian and one postintervention booster session 6\xa0weeks later']","['Acceptability and feasibility', 'mean session duration']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0280443,"RESULTS


Of the 19 parents who started the intervention","[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Touyz', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Garnett', 'Affiliation': ""Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.""}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Grech', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Paayal', 'Initials': 'P', 'LastName': 'Gohil', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Cohn', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wakefield', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.""}]",Pediatric blood & cancer,['10.1002/pbc.28533']
1282,32646264,Bias and Loss to Follow-Up in Cardiovascular Randomized Trials: A Systematic Review.,"Background Loss to follow-up (LTFU) is common in randomized controlled trials. However, its potential impact on primary outcomes from cardiovascular randomized controlled trials is not known. Methods and Results We conducted a prospective systematic review (PROSPERO: CRD42019121959) for randomized controlled trials published in 8 leading journals over 5 years from January 2014 to December 2018. Extent, reporting, and handling of LTFU data were recorded, and the proportion of a trial's primary outcome results that lose statistical significance was calculated after making plausible assumptions for the intervention and control arms. These assumptions could drive differential treatment effects between the groups considering relative event incidence between LTFU participants and those included in the primary outcome. We identified 117 randomized controlled trials of which 91 (78%) trials reported LTFU, 23 (20%) reported no LTFU, and 3 (3%) trials did not report on whether LTFU occurred. The median percentage of study participants lost to follow-up was 2% (interquartile range, 0.33%-5.3%). Only 10 trials (9%) had a low cluster of risk factors for impairment in trial quality. The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm. Conclusions Almost 1 in 6 (16%) cardiovascular randomized trials published in leading journals may have a change in the primary outcome if plausible assumptions are made about differential event rates of participants lost to follow up. There is scope for improvement arising from LTFU in randomized trials in cardiovascular medicine. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42019121959.",2020,The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm.,"['117 randomized controlled trials of which 91 (78', '8 leading journals over 5\xa0years from January 2014 to December 2018']",[' Loss to follow-up (LTFU'],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],,0.329949,The percentage of trials losing statistical significance varied from 2% when the relative event incidence for LTFU between the randomized groups was 1 for the intervention arm and 1.5 for the control arm to 16% when the relative event incidence was 3 for the intervention arm and 1 for the control arm.,"[{'ForeName': 'Lucas Chun Wah', 'Initials': 'LCW', 'LastName': 'Fong', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Glasgow Scotland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation Dalla Lana School of Public Health University of Toronto.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Department of Medicine University of Toronto Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Glasgow Scotland.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015361']
1283,32652133,Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study.,"Cigarette smoking during pregnancy increases risk for pregnancy complications, growth restriction, and other adverse health outcomes. The most effective intervention for reducing smoking during pregnancy is financial incentives contingent on biochemically-verified smoking abstinence. The present study examined the efficacy of a smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app. If efficacious, this remote intervention would allow pregnant women residing in geographically remote areas to benefit from incentives-based cessation interventions. Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook. Participants were assigned sequentially to one of two treatments: best practices alone (N = 30) or best practices plus financial incentives (N = 30). Outcomes were analyzed using repeated measures analysis based on generalized estimating equations (GEE). Seven-day point prevalence abstinence rates were greater in the incentives versus best practices arms early- (46.7% vs 20.0%, OR = 3.50, 95%CI = 1.11,11.02) and late-antepartum (36.7% vs 13.3%, OR = 3.76, 95%CI = 1.04,13.65), and four- (36.7% vs 10.0%, OR = 5.21, 95%CI = 1.28,21.24) and eight-weeks postpartum (40.0% vs 6.7%, OR = 9.33, 95%CI = 1.87,46.68), although not at the 12- (23.3% vs 10.0%, OR = 2.74, 95%CI = 0.63,11.82) or 24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion. These results support the efficacy of this remote, incentives-based intervention for pregnant smokers. Further research evaluating its efficacy and cost-effectiveness in a well-powered, randomized controlled trial appears warranted.",2020,"24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion.","['pregnant smokers', 'Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook']","['practices alone (N\u202f=\u202f30) or best practices plus financial incentives', 'smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app', 'Smartphone-based financial incentives']","['Cigarette smoking', 'efficacy and cost-effectiveness', 'prevalence abstinence rates', 'late-antepartum']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}]",60.0,0.125537,"24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion.","[{'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Kurti', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA; Psychological Science, University of Vermont, Burlington, VT, USA. Electronic address: akurti@uvm.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Hypatia A', 'Initials': 'HA', 'LastName': 'Bolivar', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Evemy', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA; Psychological Science, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Medina', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Skelly', 'Affiliation': 'Medical Biostatistics, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Nighbor', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, Burlington, VT, USA; Departments of Psychiatry, University of Vermont, Burlington, VT, USA; Psychological Science, University of Vermont, Burlington, VT, USA.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106201']
1284,32657909,Immunosuppressive Drug-Associated Adverse Event Profiles in De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses.,"BACKGROUND


The safety of immunosuppressive regimens is influenced by the induction agent, maintenance drug combination, and prophylactic strategy for cytomegalovirus (CMV) infection. Herein, this safety analysis compares rabbit antithymocyte globulin (r-ATG) or basiliximab (BAS) combined with everolimus (EVR) versus BAS combined with mycophenolate sodium (MPS) in kidney transplant recipients receiving tacrolimus, prednisone, and preemptive CMV therapy.
METHODS


In this single-center, prospective, randomized study, adverse events (AEs), serious AEs (SAEs), viral infections, laboratory abnormalities, dose reductions, and temporary or permanent discontinuation of the immunosuppressant were compared among patients receiving r-ATG/EVR (n = 85), BAS/EVR (n = 102), and BAS/MPS (n = 101).
RESULTS


A total of 2741 AEs and 344 SAEs were observed. There were no differences in the proportion of patients with at least one AE (96% versus 98% versus 96%, respectively; P > 0.05). The proportion of patients with at least one SAE was highest in the BAS/MPS group (33% versus 48% versus 69%, respectively; P < 0.05). This difference was due primarily to a high incidence of CMV infection in the BAS/MPS group (4.7% versus 10.8% versus 37.6%, respectively). The incidence of mild/moderate abnormalities in creatinine, cholesterol, and triglyceride levels was higher in both EVR groups. The cumulative freedom from dose reduction or treatment discontinuation due to an AE was higher in both EVR groups than in the BAS/MPS group (89.2% versus 92.8% versus 76.3%, respectively, P = 0.003). There was no difference in the incidence of biopsy-confirmed acute rejection (9.4% versus 18.6 versus 15.8%, respectively; P = 0.403).
CONCLUSIONS


This analysis suggests that r-ATG induction combined with EVR is associated with a comparable incidence of acute rejection, lower incidence of CMV infection, and fewer changes in initial immunosuppressive regimen due to AEs in kidney transplant recipients receiving tacrolimus, prednisone, and preemptive CMV therapy.",2020,"The cumulative freedom from dose reduction or treatment discontinuation due to an AE was higher in both EVR groups than in the BAS/MPS group (89.2% vs 92.8% vs 76.3%, respectively, p=0.003).","['De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses', 'kidney transplant recipients receiving']","['tacrolimus, prednisone, and preemptive CMV therapy', 'BAS/MPS', 'rabbit anti-thymocyte globulin (r-ATG) or basiliximab (BAS) combined with everolimus (EVR) versus BAS combined with mycophenolate sodium (MPS']","['cumulative freedom', 'incidence of mild/moderate abnormalities in creatinine, cholesterol, and triglyceride levels', 'adverse events (AEs), serious adverse events (SAEs), viral infections, laboratory abnormalities, dose reductions, and temporary or permanent discontinuation of the immunosuppressant', 'CMV infection', 'incidence of biopsy-confirmed acute rejection']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]",2741.0,0.0441977,"The cumulative freedom from dose reduction or treatment discontinuation due to an AE was higher in both EVR groups than in the BAS/MPS group (89.2% vs 92.8% vs 76.3%, respectively, p=0.003).","[{'ForeName': 'Tamiris A', 'Initials': 'TA', 'LastName': 'Miranda', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazilo.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Felipe', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazilo.'}, {'ForeName': 'Renato H N', 'Initials': 'RHN', 'LastName': 'Santos', 'Affiliation': 'HCor Research Institute, Hospital do Coração, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jose O', 'Initials': 'JO', 'LastName': 'Medina Pestana', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazilo.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco-Silva Junior', 'Affiliation': 'Division of Nephrology, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, São Paulo, Brazilo.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000790']
1285,32653414,"Re: Toni K. Choueiri, Daniel Y.C. Heng, Jae Lyun Lee, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. In press. https://doi.org/10.1001/jamaoncol.2020.2218: SAVOIR: From Own Goal to Winning Goal?",,2020,,"['Patients With MET-Driven Papillary Renal Cell Carcinoma', 'https://doi.org/10.1001/jamaoncol.2020.2218']","['SAVOIR', 'Savolitinib vs Sunitinib']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}]",[],,0.0560533,,"[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: francesco.massari@aosp.bo.it.'}]",European urology oncology,['10.1016/j.euo.2020.06.008']
1286,32618122,Prospective randomized trial of interventions for vincristine-related neuropathic pain.,"BACKGROUND


To evaluate the efficacy of gabapentin at 20 mg/kg per day in the treatment of vincristine-related neuropathic pain.
PROCEDURE


Children aged 1-18 years who developed vincristine-induced neuropathy on a St Jude frontline acute lymphoblastic leukemia trial were prospectively enrolled on a randomized, double-blind, placebo-controlled, phase II trial with two treatment arms: gabapentin plus opioid versus placebo plus opioid. Daily evaluations of morphine dose (mg/kg per day) and pain scores were conducted for up to 21 days; the values of the two arms were compared to assess analgesic efficacy.
RESULTS


Of 51 study participants, 49 were eligible for analyses. Twenty-five participants were treated with gabapentin, with a mean (SD) dose of 17.97 (2.76) mg/kg per day (median 18.26, range 6.82-21.37). The mean (SD) opioid doses taken, expressed as morphine equivalent daily (mg/kg per day), were 0.26 (0.43) in the gabapentin group (25 patients, 432 days) and 0.15 (0.22) in the placebo group (24 patients, 411 days; P = .15). Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178): patients in the lower risk arm received higher daily morphine dosages. Multivariate analyses revealed a significant difference between the groups' average daily scores for the previous 24 h and ""right now.""
CONCLUSION


In this population of children with vincristine-related neuropathic pain, opioid consumption and pain scores were higher in the gabapentin group than in the placebo group. Future randomized, double-blind, placebo-controlled studies should test gabapentin given longer or at a higher dose.",2020,Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178),['Children aged 1-18\xa0years who developed vincristine-induced neuropathy on a St Jude frontline acute lymphoblastic leukemia trial'],"['vincristine', 'gabapentin plus opioid versus placebo plus opioid', 'placebo', 'gabapentin', 'morphine']","['neuropathic pain, opioid consumption and pain scores', 'pain scores', 'analgesic efficacy', 'risk classification of acute lymphoblastic leukemia', 'neuropathic pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]",25.0,0.610989,Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178),"[{'ForeName': 'Doralina L', 'Initials': 'DL', 'LastName': 'Anghelescu', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jessica Michala', 'Initials': 'JM', 'LastName': 'Tesney', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Becky B', 'Initials': 'BB', 'LastName': 'Wright', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Trujillo', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Sandlund', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pauley', 'Affiliation': ""Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Deqing', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}]",Pediatric blood & cancer,['10.1002/pbc.28539']
1287,32619050,Super-mini percutaneous nephrolithotomy (PCNL) vs standard PCNL for the management of renal calculi of <2 cm: a randomised controlled study.,"OBJECTIVE


To compare the effectiveness and safety of standard percutaneous nephrolithotomy (sPCNL) and super-mini PCNL (SMP).
PATIENTS AND METHODS


A total of 150 patients presenting with renal calculi of <2 cm were randomised to either sPCNL (Group 1) or SMP (Group 2). Randomisation was based on centralised computer-generated numbers. Variables studied included: stone-free rates (SFRs), operative time, intra- and postoperative complications, postoperative pain score, analgesic requirement, and hospital stay. Statistical analysis was performed using a t-test or Mann-Whitney U-test for continuous variables and chi-squared test or Fisher's exact test for categorical variables.
RESULTS


Between September 2018 and April 2019, 75 patients were included in each group. The SFRs of the groups were similar (97.33 vs 98.66%, P = 0.56). The mean (sd) operative time was significantly longer in Group 2, at 36.40 (14.07) vs 23.12 (11.96) min (P < 0.001). The mean (sd) decrease in haemoglobin was significantly less in Group 2, at 3.0 (4.9) vs 7.5 (6.5) g/L (P < 0.001). The mean (sd) pain score at 24 h was significantly lower in Group 2, at 0.3 (0.46) vs 0.75 (0.53) (P < 0.001). The mean (sd) analgesic requirement was significantly less in Group 2, at 67 (22.49) vs 91.5 (30.56) mg tramadol (P < 0.001). The mean (sd) hospital stay was significantly less in Group 2, at 28.38 (3.6) vs 39.84 (3.7) h (P < 0.001).
CONCLUSIONS


SMP is equally as effective as sPCNL for managing renal calculi of <2 cm, with improved safety. Although SMP is associated with a longer operative time, it has a significantly lower incidence of bleeding and postoperative pain, and a shorter hospital stay.",2020,"The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56).","['75 patients were included in each group', 'Between September 2018 and April 2019', 'renal calculi < 2 cm', '150 patients presenting with renal calculi < 2 cm']","['Super-mini Percutaneous Nephrolithotomy (SMP) vs Standard Percutaneous Nephrolithotomy (sPNL', 'SMP', 'standard and super-mini PNL (SMP']","['stone free rates, operating time, intra-operative and postoperative complications, postoperative pain score, analgesic requirement and hospital stay', 'stone free rates', 'efficacy and safety', 'Mean [SD] decrease in hemoglobin', 'Mean [SD] pain score', 'bleeding, postoperative pain score and lesser hospital stay', 'Mean [SD] operating time (minutes', 'Mean [SD] hospital stay (hours', 'Mean [SD] analgesic requirement (mg tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",75.0,0.0697676,"The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56).","[{'ForeName': 'Raja Sekhar', 'Initials': 'RS', 'LastName': 'Guddeti', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Padmaraj', 'Initials': 'P', 'LastName': 'Hegde', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}, {'ForeName': 'Jean J M C H', 'Initials': 'JJMCH', 'LastName': 'de la Rosette', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Laguna Pes', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Kapadia', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal Academy of Higher Education (MAHE), Manipal, Karnataka, India.'}]",BJU international,['10.1111/bju.15144']
1288,32621374,Impact of Point-of-care Testing on Length of Stay of Patients in the Emergency Department: A Cluster-randomized Controlled Study.,"OBJECTIVES


Crowding is a frequent concern in the emergency department (ED). Laboratory point-of-care testing (POCT) has been proposed to decrease patients' length of stay (LOS). Our objective was to determine whether an extended panel of POCT solutions could reduce LOS.
METHODS


This was a single-center, prospective, open-label, controlled cluster-randomized study. Blood test processing was randomized into 1-week inclusion periods: interventional arm (laboratory analyses performed on POCT analyzers implemented in the ED) or control arm (central laboratory). The primary endpoint was LOS of patients in the ED. Secondary endpoints were time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm.
RESULTS


A total of 23,231 patients were included and 20,923 were analyzed for the main outcome measure. Mean ± SD age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling. Mean ± SD LOSs were 203 ± 161 and 210 ± 168 minutes in the POCT and control arms, respectively. LOS reduction for the entire ED population was -9 minutes (95% confidence interval [CI] = -22 to 5, p = 0.22) compared to the control arm and -17 minutes (95% CI = -34.0 to 0.6, p = 0.06) for patients undergoing blood sampling. The mean ± SD TTRs were 28 ± 31 and 79 ± 34 minutes in the POCT and control arms, respectively (TTR reduction = -51 minutes, 95% CI = -54 to -48 minutes, p < 0.001).
CONCLUSIONS


The implementation of an extended panel of POCT solutions in an ED did not significantly reduce the LOS, but reduced the TTR.",2020,"Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively.","['Mean age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling', 'of patients in the emergency department', 'A total of 23,231 patients']","['care testing (POCT', 'care testing']","['LOS reduction', 'LOS', 'length of stay', ""patients' length of stay (LOS"", 'time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm', 'TTR reduction']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",23231.0,0.138528,"Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Hausfater', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': 'the, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), Sorbonne Université, APHP, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bulsei', 'Affiliation': ""the, AP-HP URC Eco Ile de France Hôpital de l'Hôtel Dieu, Paris, France.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Canavaggio', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lafourcade', 'Affiliation': 'the, Unité de Recherche Clinique Salpêtrière-Charles Foix, APHP, Paris, France.'}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Paquet', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Arock', 'Affiliation': 'the, Sorbonne Université, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""the, AP-HP URC Eco Ile de France Hôpital de l'Hôtel Dieu, Paris, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Riou', 'Affiliation': 'From the, Emergency Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Oueidat', 'Affiliation': 'and the, Biochemisty and Emergency Biology Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14072']
1289,32627859,Information fraction estimation based on the number of events within the standard treatment regimen.,"For a Phase III randomized trial that compares survival outcomes between an experimental treatment versus a standard therapy, interim monitoring analysis is used to potentially terminate the study early based on efficacy. To preserve the nominal Type I error rate, alpha spending methods and information fractions are used to compute appropriate rejection boundaries in studies with planned interim analyses. For a one-sided trial design applied to a scenario in which the experimental therapy is superior to the standard therapy, interim monitoring should provide the opportunity to stop the trial prior to full follow-up and conclude that the experimental therapy is superior. This paper proposes a method called total control only (TCO) for estimating the information fraction based on the number of events within the standard treatment regimen. Based on theoretical derivations and simulation studies, for a maximum duration superiority design, the TCO method is not influenced by departure from the designed hazard ratio, is sensitive to detecting treatment differences, and preserves the Type I error rate compared to information fraction estimation methods that are based on total observed events. The TCO method is simple to apply, provides unbiased estimates of the information fraction, and does not rely on statistical assumptions that are impossible to verify at the design stage. For these reasons, the TCO method is a good approach when designing a maximum duration superiority trial with planned interim monitoring analyses.",2020,"The TCO method is simple to apply, provides unbiased estimates of the information fraction, and does not rely on statistical assumptions that are impossible to verify at the design stage.",[],[],[],[],[],[],,0.0244162,"The TCO method is simple to apply, provides unbiased estimates of the information fraction, and does not rely on statistical assumptions that are impossible to verify at the design stage.","[{'ForeName': 'Ha M', 'Initials': 'HM', 'LastName': 'Dang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Alonzo', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Krailo', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sandrah P', 'Initials': 'SP', 'LastName': 'Eckel', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Biometrical journal. Biometrische Zeitschrift,['10.1002/bimj.201900236']
1290,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
1291,32636099,Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial).,"BACKGROUND


Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty.
OBJECTIVE


To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.
DESIGN, SETTING, AND PARTICIPANTS


This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy.
INTERVENTION


Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention.
RESULTS AND LIMITATIONS


The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31-0.89]).
CONCLUSIONS


In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.
PATIENT SUMMARY


There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions.",2020,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"['adult men with recurrent bulbar urethral stricture', 'UK National Health Service hospitals were recruited and 222 men', 'Recurrent Bulbar Urethral Stricture', 'men with recurrent bulbar urethral stricture']","['urethrotomy and urethroplasty', 'urethrotomy with open urethroplasty', 'Urethrotomy', 'urethroplasty or urethrotomy', 'Open Urethroplasty Versus Endoscopic Urethrotomy']","['voiding symptom score', 'reinterventions', 'time until reintervention', 'voiding symptoms', 'effectiveness and cost-effectiveness', 'symptom scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0194550', 'cui_str': 'Incision of urethra'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",222.0,0.165454,The mean difference between the urethroplasty and urethrotomy groups was -0.36,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Carnell', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Breckons', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: luke.vale@ncl.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Whybrow', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rapley', 'Affiliation': 'Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forbes', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Currer', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Andrich', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mundy', 'Affiliation': 'University College London Hospital, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': ""N'Dow"", 'Affiliation': 'Academic Urology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'Central Manchester Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Watkin', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pickard', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK.'}]",European urology,['10.1016/j.eururo.2020.06.003']
1292,32649925,"Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.","BACKGROUND


Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis.
METHODS


We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433.
FINDINGS


Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial.
INTERPRETATION


This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence.
FUNDING


National Institute for Health Research.",2020,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","['101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to', 'young people with first-episode psychosis', 'adolescents with first-episode psychosis (MAPS', 'participants from seven UK National Health Service Trust sites', 'adolescents with first-episode psychosis', 'Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service', 'The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups', 'early-onset psychosis']","['CBT', 'antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention', 'antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT', 'antipsychotic monotherapy', 'Antipsychotic medication versus psychological intervention', 'antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention', 'antipsychotics plus psychological intervention']","['feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS', 'serious adverse events', 'PANSS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0011251', 'cui_str': 'Delusional disorder'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.11201,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK. Electronic address: anthony.p.morrison@manchester.ac.uk.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maughan', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': ""Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK; Institute for Mental Health and Centre for Human Brain Health, School of Psychology, University of Birmingham, Birmingham, UK; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK; Early Intervention in Psychosis Service, Lancashire and South Cumbria NHS Foundation Trust, Chorley, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh Medical School, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'National Institute for Health Research (NIHR) MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30248-0']
1293,32653359,The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial.,"OBJECTIVE


This study investigated the effects of three auditory interventions; white noise, recorded mother's voice, and MiniMuffs, applied during a heel lance on pain and comfort in premature infants in the neonatal intensive care units.
DESIGN AND METHODS


This experimental, parallel, randomised controlled research was conducted in a state hospital tertiary-level neonatal intensive care unit. The sample comprised sixty-four premature infants with gestational ages of 31-36 weeks. The infants were randomly assigned to four groups: i) white noise, ii) recorded mother's voice, iii) MiniMuffs, and iv) control. Pain and comfort of newborns were evaluated according to the Neonatal Infant Pain Scale (NIPS) and the COMFORTneo scale. Oxygen saturation, heart rate, and crying time were also measured.
RESULTS


The mean of oxygen saturation levels in the white noise, recorded mother's voice, and MiniMuffs group were higher than the control group. The heart rate, crying time, mean NIPS score, COMFORTneo score of the premature neonates in the white noise, recorded mother's voice, and MiniMuffs groups were significantly lower than the control group (p < .001).
CONCLUSION


Auditory interventions used during heel lance reduce the pain and increase the comfort of the premature infants. White noise is extremely effective in preventing infants's pain.",2020,"The mean of oxygen saturation levels in the white noise, recorded mother's voice, and MiniMuffs group were higher than the control group.","['state hospital tertiary-level neonatal intensive care unit', 'premature infants in the neonatal intensive care units', 'sample comprised sixty-four premature infants with gestational ages of 31-36\xa0weeks', 'premature newborns in the neonatal intensive care unit']","[""white noise, ii) recorded mother's voice, iii) MiniMuffs, and iv) control"", 'auditory interventions', ""three auditory interventions; white noise, recorded mother's voice, and MiniMuffs, applied during a heel lance"", 'Auditory interventions']","['pain and comfort', 'Pain and comfort of newborns', 'Neonatal Infant Pain Scale (NIPS) and the COMFORTneo scale', ""heart rate, crying time, mean NIPS score, COMFORTneo score of the premature neonates in the white noise, recorded mother's voice"", 'Oxygen saturation, heart rate, and crying time', 'mean of oxygen saturation levels', 'pain']","[{'cui': 'C0020026', 'cui_str': 'State Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0522666', 'cui_str': 'Lance'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0553415,"The mean of oxygen saturation levels in the white noise, recorded mother's voice, and MiniMuffs group were higher than the control group.","[{'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Kahraman', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey. Electronic address: ayse.kahraman@ege.edu.tr.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Akar', 'Affiliation': 'Izmir Tepecik Training and Research Hospital, Division of Neonatology, İzmir, Turkey.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Sipahi', 'Affiliation': 'Izmir Tepecik Training and Research Hospital, Division of Neonatology, İzmir, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Bal Yılmaz', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey.'}, {'ForeName': 'Zümrüt', 'Initials': 'Z', 'LastName': 'Başbakkal', 'Affiliation': 'Ege University Faculty of Nursing, Pediatric Nursing, Department, İzmir, Turkey.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102904']
1294,32667270,Prospective Long-term Follow-up of Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation: A Randomized Clinical Trial.,"BACKGROUND


Matrix-associated autologous chondrocyte implantation (MACI) is a further development of the original autologous chondrocyte implantation periosteal flap technique (ACI-P) for the treatment of articular cartilage defects.
PURPOSE


We aimed to establish whether MACI or ACI-P provides superior long-term outcomes in terms of patient satisfaction, clinical assessment, and magnetic resonance imaging (MRI) evaluation.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 21 patients with cartilage defects at the femoral condyle were randomized to MACI (n = 11) or ACI-P (n = 10) between the years 2004 and 2006. Patients were assessed for subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0), at 1 and 2 years postoperatively (T1, T2), and at the final follow-up 8 to 11 years after surgery (T3). Onset of osteoarthritis was determined using the Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage was used to evaluate the cartilage. Adverse events were recorded to assess safety.
RESULTS


There were 16 patients (MACI, n = 9; ACI-P, n = 7) who were reassessed on average 9.6 years after surgery (76% follow-up rate). The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2. IKDC scores increased significantly at all postoperative evaluation time points in ACI-P. In MACI, IKDC scores showed a significant increase at T1 and T3 when compared with T0. In the majority of the patients (10/16; MACI, 5/9; ACI-P, 5/7) a complete defect filling was present at the final follow-up as shown by the MOCART score, and 1 patient in the ACI-P group displayed hypertrophy of the repair tissue, which represents 6% of the whole study group and 14.3% of the ACI-P group. Besides higher SF-36 vitality scores in ACI-P at T3, no significant differences were seen in clinical scores and MRI scores between the 2 methods at any time point. Revision rate was 33.3% in MACI and 28.6% in ACI-P at the last follow-up.
CONCLUSION


Our long-term results suggest that first- and third-generation ACI methods are equally effective treatments for isolated full-thickness cartilage defects of the knee. With the number of participants available, no significant difference was noted between MACI and ACI-P at any time point. Interpretation of our data has to be performed with caution due to the small sample size, which was further limited by a loss to follow-up of 24%.",2020,The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2.,"['A total of 21 patients with cartilage defects at the femoral condyle', 'n = 11) or ACI-P (n = 10) between the years 2004 and 2006']","['MACI', 'Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation', 'MACI or ACI-P', 'Matrix-associated autologous chondrocyte implantation (MACI']","['Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage', 'hypertrophy of the repair tissue', 'SF-36 vitality scores', 'Adverse events', 'complete defect filling', 'MACI, IKDC scores', 'Revision rate', 'clinical scores and MRI scores', 'Lysholm and Gillquist score', 'IKDC scores', 'subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0031110', 'cui_str': 'Periosteum'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Level'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",21.0,0.102406,The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barié', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Kruck', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sorbi', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rehnitz', 'Affiliation': 'Diagnostic and Interventional Radiology, Department of Radiology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Oberle', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zeifang', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520928337']
1295,32631074,"Utility of Neuromuscular Electrical Stimulation to Preserve Quadriceps Muscle Fiber Size and Contractility After Anterior Cruciate Ligament Injuries and Reconstruction: A Randomized, Sham-Controlled, Blinded Trial.","BACKGROUND


Anterior cruciate ligament (ACL) injuries and reconstruction (ACLR) promote quadriceps muscle atrophy and weakness that can persist for years, suggesting the need for more effective rehabilitation programs. Whether neuromuscular electrical stimulation (NMES) can be used to prevent maladaptations in skeletal muscle size and function is unclear.
PURPOSE


To examine whether early NMES use, started soon after an injury and maintained through 3 weeks after surgery, can preserve quadriceps muscle size and contractile function at the cellular (ie, fiber) level in the injured versus noninjured leg of patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Patients (n = 25; 12 men/13 women) with an acute, first-time ACL rupture were randomized to NMES (5 d/wk) or sham (simulated microcurrent electrical nerve stimulation; 5 d/wk) treatment to the quadriceps muscles of their injured leg. Bilateral biopsies of the vastus lateralis were performed 3 weeks after surgery to measure skeletal muscle fiber size and contractility. Quadriceps muscle size and strength were assessed 6 months after surgery.
RESULTS


A total of 21 patients (9 men/12 women) completed the trial. ACLR reduced single muscle fiber size and contractility across all fiber types ( P  < .01 to  P  < .001) in the injured compared with noninjured leg 3 weeks after surgery. NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001). NMES preserved contractility in slow-twitch MHC I fibers ( P  < .01 to  P  < .001), increasing maximal contractile velocity ( P  < .01) and preserving power output ( P  < .01), but not in MHC II fibers. Differences in whole muscle strength between groups were not discerned 6 months after surgery.
CONCLUSION


Early NMES use reduced skeletal muscle fiber atrophy in MHC II fibers and preserved contractility in MHC I fibers. These results provide seminal, cellular-level data demonstrating the utility of the early use of NMES to beneficially modify skeletal muscle maladaptations to ACLR.
CLINICAL RELEVANCE


Our results provide the first comprehensive, cellular-level evidence to show that the early use of NMES mitigates early skeletal muscle maladaptations to ACLR.
REGISTRATION


NCT02945553 (ClinicalTrials.gov identifier).",2020,NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001).,"['Patients (n = 25; 12 men/13 women) with an acute, first-time ACL rupture', '21 patients (9 men/12 women) completed the trial', 'After Anterior Cruciate Ligament Injuries and Reconstruction']","['Anterior cruciate ligament (ACL) injuries and reconstruction (ACLR', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'NMES (5 d/wk) or sham (simulated microcurrent electrical nerve stimulation; 5 d/wk) treatment to the quadriceps muscles of their injured leg']","['maximal contractile velocity', 'preserving power output', 'Quadriceps Muscle Fiber Size and Contractility', 'ACLR reduced single muscle fiber size and contractility', 'Quadriceps muscle size and strength', 'fast-twitch myosin heavy chain (MHC) II fibers', 'contractility in slow-twitch MHC', 'muscle fiber atrophy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0333751', 'cui_str': 'Muscle fiber atrophy'}]",21.0,0.154142,NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Choquette', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Anair', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Failla', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapslaey', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Denver, Colorado, USA.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'Endres', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Slauterbeck', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Beynnon', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}]",The American journal of sports medicine,['10.1177/0363546520933622']
1296,32638445,Effect of cinnamon on migraine attacks and inflammatory markers: A randomized double-blind placebo-controlled trial.,"Migraine is the most common type of primary headaches. Increased levels of interleukin-6 (IL-6), calcitonin-gene-related peptide (CGRP) and nitric oxide (NO) lead to inflammation and neurogenic pain. Cinnamon has anti-inflammatory and neuroprotective properties. Thus, the aim of this study was to assess the effect of cinnamon on migraine attacks and inflammatory status. Fifty patients with migraine were randomized to receive either cinnamon powder (three capsules/day each containing 600 mg of cinnamon) or three placebo capsules/day each containing 100 mg of corn starch (control group) for 2 months. Serum levels of IL-6, CGRP and NO were measured at baseline and at the end of the study. The frequency, severity and duration of pain attacks were also recorded using questionnaire. Serum concentrations of IL-6 and NO were significantly reduced in the cinnamon group compared with the control group (p < .05). However, serum levels of CGRP remained unchanged in both groups. The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group. Cinnamon supplementation reduced inflammation as well as frequency, severity and duration of headache in patients with migraine. Cinnamon could be regarded as a safe supplement to relieve pain and other complications of migraine.",2020,"The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group.","['Fifty patients with migraine', 'patients with migraine']","['Cinnamon supplementation', 'cinnamon', 'cinnamon powder (three capsules/day each containing 600\u2009mg of cinnamon) or three placebo capsules/day each containing 100\u2009mg of corn starch', 'placebo']","['migraine attacks and inflammatory markers', 'serum levels of CGRP', 'frequency, severity and duration of migraine attacks', 'frequency, severity and duration of headache', 'Serum levels of IL-6, CGRP', 'Serum concentrations of IL-6', 'migraine attacks and inflammatory status', 'frequency, severity and duration of pain attacks', 'Increased levels of interleukin-6 (IL-6), calcitonin-gene-related peptide (CGRP) and nitric oxide (NO) lead to inflammation and neurogenic pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0423717', 'cui_str': 'Neurogenic pain'}]",50.0,0.147185,"The frequency, severity and duration of migraine attacks were significantly decreased in the cinnamon group compared with the control group.","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Zareie', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Department of Neurology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hasanzadeh', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6721']
1297,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1298,32652528,Secukinumab 2-weekly vs. 4-weekly dosing in patients with plaque-type psoriasis: results from the randomized GAIN study.,"BACKGROUND


Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin-17A and shows long-lasting efficacy and safety in plaque psoriasis. More evidence is required to optimize secukinumab dosing according to clinical response.
OBJECTIVES


GAIN compared the efficacy and safety of secukinumab 300 mg every 2 weeks (q2w) with 300 mg every 4 weeks (q4w) in patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) but not PASI 90 after 16 weeks.
METHODS


In total, 772 patients with moderate-to-severe plaque psoriasis received secukinumab 300 mg subcutaneously at baseline and weeks 1, 2, 3 and 4, then q4w until week 16. At week 16, patients with PASI ≥ 75 to PASI < 90 were randomized 1: 1 to continue q4w dosing (n = 162) or switch to q2w (n = 163) to week 32. The primary endpoint was superiority of q2w to q4w dosing for PASI 90 response at week 32.
RESULTS


PASI 90 response at week 32 was numerically greater with secukinumab 300 mg q2w than with secukinumab 300 mg q4w in suboptimal responders, but this did not reach statistical significance (64·4% vs. 57·4%; odds ratio 0·64, 95% confidence interval 0·39-1·07; P = 0·087). Although the primary endpoint was not met, absolute PASI was significantly lower at week 32 in q2w vs. q4w patients (2·11 vs. 2·84, P = 0·024). Significantly more patients with q2w vs. q4w dosing showed minimal disease activity (Investigator's Global Assessment score 0 or 1: 73·0% vs. 64·1%, P < 0·05) and improved quality of life (Dermatology Life Quality Index score 0 or 1: 58·9% vs. 50·6%, P < 0·05) at week 32. No new or unexpected safety signals arose.
CONCLUSIONS


Most patients achieved PASI 90 response with secukinumab q4w. There was potential benefit of q2w dosing in some suboptimal responders. Continued q4w treatment can improve response even after 16 weeks.",2020,"RESULTS


PASI90 response at Week 32 was numerically greater with secukinumab 300mg q2w than with 300mg q4w in suboptimal responders, not reaching statistical significance (64.4% vs. 57.4%, OR0.64 95%CI[0.39, 1.07], p=0.087).","['patients with plaque-type psoriasis', '772 patients with moderate to severe plaque psoriasis received']","['secukinumab 300mg s.c', 'Secukinumab', 'secukinumab']","['absolute PASI', 'PASI90 response', 'minimal disease activity', 'efficacy and safety', 'superiority of q2w to q4w dosing for PASI90 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",772.0,0.0423939,"RESULTS


PASI90 response at Week 32 was numerically greater with secukinumab 300mg q2w than with 300mg q4w in suboptimal responders, not reaching statistical significance (64.4% vs. 57.4%, OR0.64 95%CI[0.39, 1.07], p=0.087).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Körber', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sticherling', 'Affiliation': 'Department of Dermatology, Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sieder', 'Affiliation': 'Novartis Pharma GmbH, Nürnberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Früh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bachhuber', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",The British journal of dermatology,['10.1111/bjd.19398']
1299,32648508,Postimplant Phosphodiesterase Type 5 Inhibitors Use Is Associated With Lower Rates of Thrombotic Events After Left Ventricular Assist Device Implantation.,"Background Left ventricular assist device (LVAD) thrombosis is clinically devastating and impacts the cost effectiveness of LVAD therapy for advanced heart failure. Anticoagulation and antiplatelet therapies represent the standard of care to mitigate LVAD thrombosis. Phosphodiesterase type 5 inhibitors (PDE-5is) exhibit hemodynamic, antiplatelet, and antithrombotic effects. Using a national registry, we examined the relationship of PDE-5i use on thrombotic events in patients with continuous-flow LVADs. Methods and Results We obtained data from 13 772 patients with continuous flow LVADs participating in a national registry. Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis. The primary end point was a composite of LVAD thrombosis and ischemic stroke. Patients were analyzed according to any use of PDE-5i after LVAD implantation (PDE-5i group) versus no use after LVAD implantation (no PDE-5i group). The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91;  P <0.001) at 48 months. The components of the primary end point (LVAD thrombosis: HR, 0.82; 95% CI, 0.74-0.90;  P <0.001; and ischemic stroke: HR, 0.85; 95% CI, 0.75-0.97;  P =0.019), as well as the secondary end point all-cause mortality (HR, 0.86; 95% CI, 0.79-0.93;  P <0.001) were lower in the PDE-5i group versus the no PDE-5i at 48 months post LVAD. The favorable results observed with postimplant PDE-5i use were consistent with both axial and centrifugal flow devices. Conclusions The postimplant use of PDE-5i was associated with fewer thrombotic events and improved survival in LVAD patients. A randomized clinical trial is warranted to confirm these findings.",2020,"The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91;  P <0.001) at 48 months.","['patients with continuous-flow LVADs', 'Patients implanted with primary LVADs from 2012 to 2017 were included in the analysis', '772 patients with continuous flow LVADs participating in a national registry', 'advanced heart failure']","['PDE-5i after LVAD implantation (PDE-5i group) versus no use after LVAD implantation', 'Phosphodiesterase type 5 inhibitors (PDE-5is', 'LVAD therapy']","['thrombotic events and improved survival', 'ischemic stroke', 'Thrombotic Events', 'composite of LVAD thrombosis and ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",13772.0,0.0719794,"The primary end point was significantly lower in the PDE-5i group compared with the no PDE-5i group (hazard ratio [HR], 0.84; 95% CI, 0.77-0.91;  P <0.001) at 48 months.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Xanthopoulos', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tryposkiadis', 'Affiliation': 'Independent Biostatistician Athens Greece.'}, {'ForeName': 'Filippos', 'Initials': 'F', 'LastName': 'Triposkiadis', 'Affiliation': 'Department of Cardiology University General Hospital of Larissa Greece.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Fukamachi', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Soltesz', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Young', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Eugene H', 'Initials': 'EH', 'LastName': 'Blackstone', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Kaufman Center for Heart Failure, Heart and Vascular Institute Cleveland Clinic Cleveland OH.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015897']
1300,32656955,High-Resolution Breast MRI Reconstruction Using a Deep Convolutional Generative Adversarial Network.,"BACKGROUND


A generative adversarial network could be used for high-resolution (HR) medical image synthesis with reduced scan time.
PURPOSE


To evaluate the potential of using a deep convolutional generative adversarial network (DCGAN) for generating HR pre  and HR post  images based on their corresponding low-resolution (LR) images (LR pre  and LR post  ).
STUDY TYPE


This was a retrospective analysis of a prospectively acquired cohort.
POPULATION


In all, 224 subjects were randomly divided into 200 training subjects and an independent 24 subjects testing set.
FIELD STRENGTH/SEQUENCE


Dynamic contrast-enhanced (DCE) MRI with a 1.5T scanner.
ASSESSMENT


Three breast radiologists independently ranked the image datasets, using the DCE images as the ground truth, and reviewed the image quality of both the original LR images and the generated HR images. The BI-RADS category and conspicuity of lesions were also ranked. The inter/intracorrelation coefficients (ICCs) of mean image quality scores, lesion conspicuity scores, and Breast Imaging Reporting and Data System (BI-RADS) categories were calculated between the three readers.
STATISTICAL TEST


Wilcoxon signed-rank tests evaluated differences among the multireader ranking scores.
RESULTS


The mean overall image quality scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.77 ± 0.41 vs. 3.27 ± 0.43 and 4.72 ± 0.44 vs. 3.23 ± 0.43, P < 0.0001, respectively, in the multireader study). The mean lesion conspicuity scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.18 ± 0.70 vs. 3.49 ± 0.58 and 4.35 ± 0.59 vs. 3.48 ± 0.61, P < 0.001, respectively, in the multireader study). The ICCs of the image quality scores, lesion conspicuity scores, and BI-RADS categories had good agreements among the three readers (all ICCs >0.75).
DATA CONCLUSION


DCGAN was capable of generating HR of the breast from fast pre- and postcontrast LR and achieved superior quantitative and qualitative performance in a multireader study.
LEVEL OF EVIDENCE


3 TECHNICAL EFFICACY STAGE: 2 J. MAGN. RESON. IMAGING 2020;52:1852-1858.",2020,"The mean overall image quality scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.77 ± 0.41 vs. 3.27 ± 0.43 and 4.72 ± 0.44 vs. 3.23 ± 0.43, P < 0.0001, respectively, in the multireader study).",['224 subjects were randomly divided into 200 training subjects and an independent 24 subjects testing set'],['deep convolutional generative adversarial network (DCGAN'],"['intracorrelation coefficients (ICCs) of mean image quality scores, lesion conspicuity scores, and Breast Imaging Reporting and Data System (BI-RADS) categories', 'ICCs of the image quality scores, lesion conspicuity scores, and BI-RADS categories', 'mean lesion conspicuity scores of the generated HR pre  and HR post', 'mean overall image quality scores of the generated HR pre  and HR post']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",224.0,0.0301274,"The mean overall image quality scores of the generated HR pre  and HR post  were significantly higher than those of the original LR pre  and LR post  (4.77 ± 0.41 vs. 3.27 ± 0.43 and 4.72 ± 0.44 vs. 3.23 ± 0.43, P < 0.0001, respectively, in the multireader study).","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liangqiong', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Chunfeng', 'Initials': 'C', 'LastName': 'Lian', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology and BRIC, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bingqing', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, International Peace Maternity and Child Health Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Ruijin Hospital Luwan Branch, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fuhua', 'Initials': 'F', 'LastName': 'Yan', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Dinggang', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'Department of Research and Development, Shanghai United Imaging Intelligence Co.,Ltd., Shanghai, China.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27256']
1301,32654255,Does physical exercise and congruent visual stimulation enhance perceptual learning?,"PURPOSE


There is currently great interest in methods that can modulate brain plasticity, both in terms of understanding the basic mechanisms, and in the remedial application to situations of sensory loss. Recent work has focussed on how different manipulations might be combined to produce new settings that reveal synergistic actions. Here we ask whether a prominent example of adult visual plasticity, called perceptual learning, is modified by other environmental factors, such as visual stimulation and physical exercise.
METHODS


We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness). We trained subjects for 5 days on a Vernier alignment task. In one group, we introduced an exercise protocol with congruent visual stimulation. The control group received the same visual stimulation, but did not exercise prior to measurement of Vernier thresholds.
RESULTS


Although the task generated large amounts of learning (~40%) and some transfer to untrained conditions in both groups, there were no specific benefits associated with either the addition of an exercise schedule or congruent visual stimulation.
CONCLUSION


In adults, short periods of physical exercise and visual stimulation do not enhance perceptual learning.",2020,"We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness).","['two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness']","['exercise protocol with congruent visual stimulation', 'physical exercise and visual stimulation', 'same visual stimulation, but did not exercise prior to measurement of Vernier thresholds', 'physical exercise and congruent visual stimulation']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",[],,0.0464675,"We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness).","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campana', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fongoni', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Astle', 'Affiliation': 'Visual Neuroscience Group, School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'McGraw', 'Affiliation': 'Visual Neuroscience Group, School of Psychology, University of Nottingham, Nottingham, UK.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12712']
1302,32659162,Compression stocking prevents increased venous retrograde flow time in the lower limbs of pregnant women.,"OBJECTIVES


To analyze the effect of graduated compression stockings on the venous reflux in the lower limbs of pregnant women.
METHOD


A controlled randomized clinical trial was performed with sixty women: intervention group (n = 30), who used compression stockings, and control group (n = 30). Using duplex-ultrasound, the reflux time and peak reflux velocity in the great saphenous vein and small saphenous vein were analyzed.
RESULTS


Great saphenous vein reflux times in the intervention group were 0.13 s at the beginning (initial) and 0.04 s at the end of pregnancy (final) in the right leg and 0.02 s and 0.34 s (p < 0.0001) in the control group. No patient in the intervention group experienced pathological reflux at the end of the pregnancy. There was a significant difference in the reflux time measured from both the great saphenous vein and small saphenous vein and peak reflux velocity between the groups.
CONCLUSION


Compression stockings prevent increased venous reflux in lower limbs of pregnant women.",2020,"There was a significant difference in the reflux time measured from both the great saphenous vein and small saphenous vein and peak reflux velocity between the groups.
","['sixty women', 'pregnant women']","['graduated compression stockings', 'Compression stocking', 'Compression stockings', 'intervention group (n\u2009=\u200930), who used compression stockings']","['venous reflux', 'venous retrograde flow time', 'great saphenous vein and small saphenous vein and peak reflux velocity', 'pathological reflux', 'Great saphenous vein reflux times', 'reflux time and peak reflux velocity', 'reflux time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0226827', 'cui_str': 'Structure of small saphenous vein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",60.0,0.0497986,"There was a significant difference in the reflux time measured from both the great saphenous vein and small saphenous vein and peak reflux velocity between the groups.
","[{'ForeName': 'Orlando Adas Saliba', 'Initials': 'OAS', 'LastName': 'Junior', 'Affiliation': 'Department of Surgery and Orthopedic Surgery, São Paulo State University (UNESP), Medical School, Botucatu, Brazil.'}, {'ForeName': 'Hamilton Almeida', 'Initials': 'HA', 'LastName': 'Rollo', 'Affiliation': 'Department of Surgery and Orthopedic Surgery, São Paulo State University (UNESP), Medical School, Botucatu, Brazil.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Saliba', 'Affiliation': 'School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Department of Surgery and Orthopedic Surgery, São Paulo State University (UNESP), Medical School, Botucatu, Brazil.'}]",Phlebology,['10.1177/0268355520939371']
1303,32659247,Children overcoming picky eating (COPE) - A cluster randomised controlled trial.,"OBJECTIVES


Food neophobia limits dietary variety in children and adults. Interventions to alleviate the impact of neophobia on children's dietary variety have had varying success. The potential effectiveness of mindfulness, a process of bringing awareness to the present moment, has received little attention. This trial aimed to explore the effectiveness of two mindfulness exercises on novel food acceptance for children.
METHODS


A cluster-randomised controlled trial with three trial arms compared the impact of two mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task on anticipated liking and intake of a novel fruit. Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention. Children self-reported mindfulness, food neophobia and anxiety at baseline and follow-up.
RESULTS


Two mixed-effects models showed that, controlling for school effects and covariates (including mindfulness, food neophobia and anxiety), children in the mindful raisin-eating arm reported greater anticipated liking of a novel fruit and children in both mindfulness arms consumed greater amounts of a novel fruit than children in the control arm. Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
CONCLUSIONS


The results provide promising evidence for the potential effectiveness of mindfulness interventions in encouraging children to try new foods. The mechanisms underlying effectiveness remain unclear and further research, exploring long-term effects and the possibility to generalise these findings to other food groups such as vegetables, is needed.",2020,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","['children and adults', 'Children overcoming picky eating (COPE) ', 'Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention', 'children']","['mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task', 'mindfulness exercises']","['school effects and covariates (including mindfulness, food neophobia and anxiety', 'mindfulness, food neophobia and anxiety', 'Children self-reported mindfulness, food neophobia and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",71.0,0.0797824,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","[{'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK. Electronic address: carmelbennett@nhs.net.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK; School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Blissett', 'Affiliation': 'Department of Psychology, School of Life and Health Sciences, Aston University, UK.'}]",Appetite,['10.1016/j.appet.2020.104791']
1304,32660708,Repeteability of Circulating Eosinophil Measures and Inhaled Corticosteroids Effect in Bronchiectasis. A Post Hoc Analysis of a Randomized Clinical Trial.,,2020,,['Bronchiectasis'],[],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}]",[],[],,0.0809084,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Archivos de bronconeumologia,['10.1016/j.arbres.2020.06.005']
1305,32665479,A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial.,"OBJECTIVE


Physical activity is associated with superior health outcomes in patients with type 2 diabetes (T2D), but most T2D patients do not follow physical activity recommendations. The objective of this study was to assess the feasibility and impact of a novel combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity in T2D.
METHODS


This controlled clinical trial compared an 8-week, phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition among 60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 min/wk). The primary study outcome was feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session). Secondary outcomes were between-group differences in changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps per day), using mixed-effects regression models, at 8 and 16 weeks.
RESULTS


Ninety-two percent of PP-MI sessions were completed, and mean participant ratings of ease/utility were 8.5 to 8.8/10, surpassing a priori benchmarks for feasibility and acceptability. PP-MI participants had small-medium effect size (ES) difference improvements in positive affect compared with MI (8 weeks: estimated mean difference [EMD] = 3.07 [SE = 1.41], p = .029, ES = 0.44; 16 weeks: EMD = 2.92 [SE = 1.73], p = .092, ES = 0.42). PP-MI participants also had greater improvements in MVPA (8 weeks: EMD = 13.05 min/d [SE = 5.00], p = .009, ES = 1.24; 16 weeks: EMD = 7.96 [SE = 4.53], p = .079, ES = 0.75), with similar improvements in steps per day.
CONCLUSIONS


The PP-MI intervention was feasible and well accepted. Next-step efficacy studies can more rigorously explore the intervention's effects on physical activity and clinical outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov Registration No. NCT03150199.",2020,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","['60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 minutes/week', 'Type 2 Diabetes', 'patients with type 2 diabetes (T2D']","['phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition', 'novel combined positive psychology-motivational interviewing (PP-MI) intervention', 'Positive Psychology-Motivational Interviewing Intervention']","['MVPA', 'feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session', 'changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps/day']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",60.0,0.10928,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'From the Harvard Medical School (Huffman, Massey, Feig, Chung, Millstein, Brown, Healy, Wexler, Park, Celano); Departments of Psychiatry (Huffman, Golden, Massey, Feig, Chung, Millstein, Brown, Gianangelo, Park, Celano), Neurology (Healy), and Medicine (Endocrinology; Wexler), Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Massey', 'Affiliation': ''}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Feig', 'Affiliation': ''}, {'ForeName': 'Wei-Jean', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': ''}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gianangelo', 'Affiliation': ''}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ''}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': ''}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000840']
1306,32668990,Is Percutaneous Nephrolithotomy the Modality of Choice Versus Extracorporeal Shockwave Lithotripsy for a 20 to 30 mm Single Renal Pelvic Stone with ≤1000 Hounsfield Unit in Adults? A Prospective Randomized Comparative Study.,"Objectives:  To compare the efficacy, complications, and costs of percutaneous nephrolithotomy (PNL) and extracorporeal shock wave lithotripsy (SWL) in the treatment of a 20 to 30 mm single renal pelvic stone with a density ≤1000 HU.  Patients and Methods:  Eighty patients were prospectively randomized to receive either PNL or SWL during May 2017 to April 2019. The relevant demographic and clinical characteristics were compared.  Results:  The mean age in the PNL and SWL groups was 43.25 ± 15.16 and 44.18 ± 12.08 years, respectively. The mean stone sizes were 25.2 ± 3.9 and 24.6 ± 2.3 mm, respectively. The stone-free rate (SFR) was significantly different after the primary procedures (92.5%  vs  37.5%, respectively;  p  < 0.04), but it was comparable after 3 months (97.5%  vs  90%, respectively;  p  = 0.723), with a higher rate of auxiliary procedures after SWL ( p  = 0.017). On multivariate analysis, stone density was the only significant variable for the SFR in the SWL group ( p  = 0.004). Complications occurred in 27.5% and 22.5% of cases, respectively ( p  = 0.796). The mean costs of SWL (650.23 ± 424.74 United States Dollars [US$]) were significantly lower than those of PNL (1137.65 ± 224.43 US$;  p  < 0.0001).  Conclusions:  The SFRs for PNL and SWL were not significantly different after 3 months in the treatment of a 20 to 30 mm single renal pelvic stone with ≤1000 HU, although PNL provided a significantly higher rate after its primary procedure. SWL was significantly less costly, but it mandated a significantly higher number of auxiliary procedures than PNL.",2020,"The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure.","['a 20-30 mm single renal pelvic stone with a density ≤1000 Hounsfield unit', 'Eighty patients']","['percutaneous nephrolithotomy', 'percutaneous nephrolithotomy and shock wave lithotripsy', 'Shock wave lithotripsy', 'percutaneous nephrolithotomy or shock wave lithotripsy', 'Percutaneous Nephrolithotomy the Modality of Choice versus Shock Wave Lithotripsy']","['efficacy, complications, and costs', 'stone sizes', 'mean costs of shock wave lithotripsy', 'Complications', 'stone free rate']","[{'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0227666', 'cui_str': 'Renal pelvis structure'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",80.0,0.0396091,"The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure.","[{'ForeName': 'Rabea Ahmed', 'Initials': 'RA', 'LastName': 'Gadelkareem', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Yaser Mahmoud', 'Initials': 'YM', 'LastName': 'Abdelsalam', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed Abdelsalam', 'Initials': 'MA', 'LastName': 'Ibraheim', 'Affiliation': 'Department of Urology, Armed Forces Medical Complex, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Reda', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Abdel-Basir', 'Initials': 'MA', 'LastName': 'Sayed', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed Shehata', 'Initials': 'AS', 'LastName': 'El-Azab', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Journal of endourology,['10.1089/end.2020.0288']
1307,32645452,Surrogate Decision Maker Stress in Advance Care Planning Conversations: A Mixed-Methods Analysis From a Randomized Controlled Trial.,"CONTEXT


Spokespersons serving as surrogate decision makers for their loved ones report high levels of stress. Despite known benefits, advance care planning (ACP) conversations often do not occur. More information is needed to understand spokesperson stress during ACP.
OBJECTIVES


To explore if and how spokespersons perceive stress related to ACP conversations; compare factors related to stress; and assess whether ACP intervention impacted stress.
METHODS


Secondary and mixed-methods analysis with data transformation of semistructured interviews occurring during a 2 × 2 factorial (four armed) randomized controlled trial that compared standard online ACP to a comprehensive online ACP decision aid. Tools were completed by patients with advanced illness (n = 285) alone or with their spokesperson (n = 285). About 200 spokesperson interviews were purposively sampled from each of the four arms (50 per arm).
RESULTS


ACP conversations were reported as stressful by 54.41% (74 of 136) and nonstressful by 45.59% (62 of 136). Five themes impacting spokesperson stress were the nature of the relationship with their loved one; self-described personality and belief systems; knowledge and experience with illness and ACP conversations; attitude toward ACP conversations; and social support in caregiving and decision making. No significant differences in stress were associated with arm assignment.
CONCLUSION


Identifying what factors impact spokesperson stress in ACP conversations can be used to help design ACP interventions to more appropriately address the needs and concerns of spokespersons.",2020,"RESULTS


ACP conversations were reported as stressful by 54.41% (74/136), and non-stressful by 45.59% (62/136).","['Advance Care Planning Conversations', 'Secondary, mixed methods analysis with data transformation of semi-structured interviews occurring during a 2x2 factorial (four armed', '200 spokesperson interviews were purposively sampled from each of the 4 arms (50 per arm', 'patients with advanced illness (n=285) alone or with their spokesperson (n=285']",['standard online ACP'],"['stress', 'nature of the relationship with their loved one, (2) self-described personality and belief systems, (3) knowledge and experience with illness and ACP conversations, (4) attitude toward ACP conversations, and (5) social support in caregiving and decision making']","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",,0.0799872,"RESULTS


ACP conversations were reported as stressful by 54.41% (74/136), and non-stressful by 45.59% (62/136).","[{'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Lipnick', 'Affiliation': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA. Electronic address: dlipnick@pennstatehealth.psu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA; Department of Medicine, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thiede', 'Affiliation': 'Penn State College of Nursing, University Park, Pennsylvania, USA.'}, {'ForeName': 'Theresa J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Lehman', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA; Public Health Sciences at Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'In Seo', 'Initials': 'IS', 'LastName': 'La', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Wiegand', 'Affiliation': 'University of Maryland School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Levi', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA; Department of Pediatrics, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Van Scoy', 'Affiliation': 'Department of Humanities, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA; Department of Medicine, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA; Public Health Sciences at Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.001']
1308,32646850,Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial.,"The PRECISION trial was a multicentre randomised study that demonstrated that multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy is superior to standard transrectal ultrasound-guided biopsy for the detection of prostate cancer. The outcomes of studies reporting mpMRI-targeted biopsies are dependent on the quality of the mpMRI but there are currently no scoring systems available for evaluating this. We introduced a novel scoring system, the Prostate Imaging Quality (PI-QUAL) score, to assess the quality of scans in the PRECISION trial. PI-QUAL is a score on a Likert scale from 1 to 5, where 1 means that no mpMRI sequences are of diagnostic quality and 5 implies that each sequence is independently of optimal diagnostic quality. Fifty-eight out of 252 (23%) mpMRI scans chosen at random from each of the 22 centres in this trial were evaluated by two experienced radiologists from the coordinating trial centre, in consensus, blinded to pathology results. Overall, the mpMRI quality in the centres participating in PRECISION was good. MpMRI quality was of sufficient diagnostic quality (PI-QUAL ≥3) for 55 scans (95%) and of good or optimal diagnostic quality (PI-QUAL ≥4) for 35 scans (60%). Fifty-five out of 58 (95%) scans were of diagnostic quality for T2WI, followed by DWI (46/58 scans; 79%), and DCE (38/58 scans; 66%). Further validation of this scoring system is warranted. PATIENT SUMMARY: In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection. We used scans from 22 centres that participated in the PRECISION trial. Although there was room for improvement in images that used intravenous contrast, we found that mpMRI in the PRECISION trial was of sufficient diagnostic quality (PI-QUAL score ≥3) for 95% of the scans.",2020,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"['prostate cancer detection', 'Fifty-eight out of 252 (23']","['multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy', 'standard transrectal ultrasound-guided biopsy', 'Prostate Imaging Quality (PI-QUAL', 'multiparametric magnetic resonance imaging (mpMRI']","['diagnostic quality', 'MpMRI quality', 'mpMRI quality', 'Prostate Imaging Quality (PI-QUAL) score']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",252.0,0.0461845,In this study we developed a scoring system (PI-QUAL) to assess the quality of multiparametric magnetic resonance imaging (mpMRI) in prostate cancer detection.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giganti', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK; Division of Surgery & Interventional Science, University College London, London, UK. Electronic address: f.giganti@ucl.ac.uk.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Emberton', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Moore', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Veeru', 'Initials': 'V', 'LastName': 'Kasivisvanathan', 'Affiliation': 'Division of Surgery & Interventional Science, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology oncology,['10.1016/j.euo.2020.06.007']
1309,32658147,A digital health psychological intervention (WebMAP Mobile) for children and adolescents with chronic pain: results of a hybrid effectiveness-implementation stepped-wedge cluster randomized trial.,"Although psychological treatments benefit youth with chronic pain, treatment is not accessible in most communities. Digital health interventions offer promise for expanding access and reach to this population. Using a stepped-wedge cluster randomized trial design, we evaluated effectiveness and implementation of a digital health delivered psychological intervention for pediatric chronic pain. One hundred forty-three youth, aged 10 to 17 years, with chronic pain and a caregiver were recruited from 8 clinics in the United States. Active intervention included access to the Web-based Management of Adolescent Pain (WebMAP) Mobile app and the WebMAP parent web site to learn pain self-management skills. Effectiveness outcomes included pain intensity, disability, and patient global impression of change, while Reach, Adoption, Implementation, and Maintenance were implementation outcomes. Results showed that youth in both treatment conditions (WebMAP vs Usual Care) had similar changes over time in pain and disability. Youth in the WebMAP condition perceived greater improvement (patient global impression of change) at post-treatment and follow-up (d's = 0.54 and 0.44, P < 0.05) compared with youth receiving usual care. Use of the digital health intervention was modest and variable; approximately 30% of youth and parents completed treatment. Greater engagement (number of completed modules) was associated with significantly greater reductions in pain and disability from pre-treatment to follow-up (d's = -0.57 and -0.38, P < 0.05). Parents, youth, and providers found treatment acceptable; providers had positive attitudes and demonstrated referrals over a maintenance period. Further research is needed to understand how to enhance treatment engagement with digital health interventions and optimize implementation.",2020,Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up,"['143 youth, ages 10-17 with chronic pain and a caregiver were recruited from 8 clinics in the United States', 'children and adolescents with chronic pain', 'pediatric chronic pain']","['digital health intervention', 'digital health delivered psychological intervention', 'Digital health interventions', 'digital health psychological intervention (WebMAP Mobile']","['pain intensity, disability, and patient global impression of change (PGIC), while Reach, Adoption, Implementation, and Maintenance were implementation outcomes', 'improvement (PGIC', 'pain and disability']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.138307,Youth in the WebMAP condition perceived greater improvement (PGIC) at post-treatment and follow-up,"[{'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de la Vega', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Murray', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Law', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.""}]",Pain,['10.1097/j.pain.0000000000001994']
1310,32658497,Treatment effects on pain catastrophizing and cutaneous allodynia symptoms in women with migraine and overweight/obesity.,"OBJECTIVE


Pain catastrophizing and cutaneous allodynia represent two risk factors for greater headache-related disability. Yet, there is limited knowledge of the extent to which these risk factors are modifiable and whether nonpharmacological treatment-related changes are associated with migraine improvements. Using data from the Women's Health and Migraine (WHAM) study, a randomized controlled trial that compared effects of behavioral weight loss (BWL) and migraine education (ME) in women with migraine and overweight/obesity, we tested whether: (a) BWL versus ME produced greater changes in pain catastrophizing and allodynia from baseline across posttreatment and follow-up time points, and (b) whether these improvements were associated with improvements in headache disability.
METHOD


Women ( N  = 110) were randomly assigned to 16 weeks of either BWL or ME and assessed at baseline, posttreatment, and follow up (32 weeks). Multilevel mixed effects modeling tested: (a) for between-groups differences in pain catastrophizing and allodynia changes over time, and (b) associations of changes in pain catastrophizing and allodynia with changes in headache disability, adjusting for migraine severity and weight loss.
RESULTS


Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions. Reductions in pain catastrophizing and cutaneous allodynia were associated with significant reductions in headache disability, even when controlling for intervention-related improvements in migraine and weight loss.
CONCLUSION


Pain catastrophizing and allodynia are not only reduced after nonpharmacologic treatments for migraine, but greater improvements are associated with greater reductions in headache-related disability, independent of migraine severity. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions.","['women with migraine and overweight/obesity', 'Women ( N  = 110']","['BWL or ME', 'behavioral weight loss (BWL) and migraine education (ME']","['pain catastrophizing and cutaneous allodynia symptoms', 'headache-related disability', 'pain catastrophizing and allodynia changes over time, and (b) associations of changes in pain catastrophizing and allodynia with changes in headache disability, adjusting for migraine severity and weight loss', 'headache disability', 'pain catastrophizing and cutaneous allodynia', 'pain catastrophizing and allodynia', 'migraine and weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1274924', 'cui_str': 'Cutaneous allodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0458247', 'cui_str': 'Allodynia'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",110.0,0.102198,"Both BWL and ME had significant reductions in pain catastrophizing and allodynia from baseline to posttreatment and follow up, and the improvements were comparable across conditions.","[{'ForeName': 'Samantha G', 'Initials': 'SG', 'LastName': 'Farris', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Mindy M', 'Initials': 'MM', 'LastName': 'Kibbey', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jelena M', 'Initials': 'JM', 'LastName': 'Pavlovic', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Kristine J', 'Initials': 'KJ', 'LastName': 'Steffen', 'Affiliation': 'School of Pharmacy.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000920']
1311,32664934,Protect MSM from HIV and other sexually transmitted diseases by providing mobile health services of partner notification: protocol for a pragmatic stepped wedge cluster randomized controlled trial.,"BACKGROUND


Recently, more and more men who have sex with men (MSM) look for casual partners through online dating platforms in China. However, most are unable to know their partners' HIV and other sexually transmitted diseases (STD) statuses, leading to the rapid increase in HIV infection among Chinese MSM. Effective partner notification is urgently needed to increase the risk awareness of MSM and prevent HIV and other STDs transmission. However, the traditional intervention mainly targets to the HIV-positive MSM and the effect is not promising. Our study aims to provide Internet-based partner notification, along with a series of health services for HIV-negative MSM to protect them from HIV and other STDs.
METHODS


A pragmatic stepped wedge cluster randomized controlled trial design is used to evaluate the effectiveness of a new intervention paradigm, which aims to reduce HIV and other STDs incidences among MSM in China. Through integrating a mobile health (mHealth) service application (app) to the current HIV and other STDs prevention and control methods, the new paradigm provides partner notification of HIV, syphilis, hepatitis B, and hepatitis C statuses. A total of 6172 MSM in 16 districts of Beijing, China will be recruited and randomized to sequentially receive partner notification intervention through the app at 6-month intervals. The primary outcomes are HIV incidence and the additional cost of the intervention. The secondary outcomes include incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes. The generalized linear mixed models (GLMM) will be used to analyze the differences of outcomes in the control period and in the intervention period.
DISCUSSION


We expect that the HIV incidence will be significantly lower and the secondary outcomes will also be improved with providing health service of partner notification through mhealth intervention. The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04349748 . Registered on 16 April 2020.",2020,"The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
","['men who have sex with men (MSM) look for casual partners through online dating platforms in China', 'A total of 6172 MSM in 16 districts of Beijing, China']",[],"['HIV incidence and the additional cost of the intervention', 'incidences of syphilis, hepatitis B, and hepatitis C, disease transmission social networks, testing adherence, knowledge of HIV and STDs control, health self-responsibility awareness, changes of high risk behaviors and other related outcomes']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6172.0,0.127014,"The feasible and affordable public health intervention paradigm will have implications for HIV and STDs prevention and control among MSM and other key populations.
","[{'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Hexuan', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Zuhong', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'State Key Laboratory for Bioelectronics, School of Biological Science and Medical Engineering, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China. urchinjj@163.com.'}]",BMC public health,['10.1186/s12889-020-09162-x']
1312,32665999,Efficacy of adding mirabegron to alpha-adrenoreceptor blocker in patients with benign prostatic hyperplasia with persistent overactive bladder symptoms: A prospective study.,"Purpose


To compare the efficacies of mirabegron 50 mg addition after alpha-adrenoreceptor blocker in terms of reducing storage symptoms in patients with BPH.
Materials and Methods


Fifty-eight patients that had been taking alpha-adrenoreceptor blocker for more than 8 weeks, but had an OABSS of greater than 3 points, were initially enrolled. One group added any alpha-adrenoreceptor blocker with mirabegron 50 mg (n=39; the mirabegron group) and the other group received alpha-adrenoreceptor blocker only (n=19; the control group) for 8 weeks.
Results


In the control group, mean total IPSS decreased from 15.7 to 13.1 (p=0.298) and in mirabegron group, mean total IPSS decreased from 19.4 to 16.5 (p=0.024). Mean storage symptom scores reduced in the control and mirabegron groups from 8.5 to 7.9 (p=0.584) and from 9.1 to 7.6 (p=0.015), respectively, and mean QoL scores from 3.7 to 3.1 (p=0.052) and 3.6 to 3.2 (p=0.027), respectively. Mean overall OABSS in the control and mirabegron groups reduced from 8.4 to 7.2 (p=0.173) and from 8.8 to 7.3, respectively (p=0.005); mean OABSS Q3 from 3.6 to 2.9 (p=0.073) and from 3.5 to 2.7 (p=0.002), respectively; and mean OABSS Q4 from 2.4 to 2.0 (p=0.306) and from 2.7 to 2.0 (p=0.016), respectively. The change of mean Qmax and PVR was insignificant in 2 groups.
Conclusions


IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms. Mirabegron 50 mg addition is considered to patients with persistent storage symptoms after alpha-adrenoreceptor blocker.",2020,"Conclusions


IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms.","['Materials and Methods\n\n\nFifty-eight patients that had been taking alpha-adrenoreceptor blocker for more than 8 weeks, but had an OABSS of greater than 3 points, were initially enrolled', 'patients with persistent storage symptoms after alpha-adrenoreceptor blocker', 'patients with benign prostatic hyperplasia with persistent overactive bladder symptoms', 'patients with BPH', 'Mirabegron 50']","['mirabegron 50 mg addition after alpha-adrenoreceptor blocker', 'alpha-adrenoreceptor blocker', 'mirabegron to alpha-adrenoreceptor blocker', 'alpha-adrenoreceptor blocker with mirabegron 50 mg']","['mean total IPSS', 'storage symptoms', 'Mean storage symptom scores', 'IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4', 'Mean overall OABSS', 'mean OABSS Q3', 'mean QoL scores', 'mean Qmax and PVR', 'mean OABSS Q4']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",58.0,0.0307978,"Conclusions


IPSS total scores, storage symptom scores, QoL, overall OABSS, OABSS Q3 and Q4 were more improved significantly by alpha-adrenoreceptor blocker with mirabegron 50 mg in BPH patients with persistent overactive symptoms.","[{'ForeName': 'Se Yun', 'Initials': 'SY', 'LastName': 'Kwon', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Dong Jin', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Seo', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Kyung Seop', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Dongguk University College of Medicine, Gyeongju, Korea.'}]",Investigative and clinical urology,['10.4111/icu.2020.61.4.419']
1313,32687804,"Safety and immunogenicity of the live attenuated intranasal pertussis vaccine BPZE1: a phase 1b, double-blind, randomised, placebo-controlled dose-escalation study.","BACKGROUND


Long-term protection and herd immunity induced by existing pertussis vaccines are imperfect, and a need therefore exists to develop new pertussis vaccines. This study aimed to investigate the safety, colonisation, and immunogenicity of the new, live attenuated pertussis vaccine, BPZE1, when given intranasally.
METHODS


This phase 1b, double-blind, randomised, placebo-controlled, dose-escalation study was done at the phase 1 unit, Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden. Healthy adults (18-32 years) were screened and included sequentially into three groups of increasing BPZE1 dose strength (10 7  colony-forming units [CFU], 10 8  CFU, and 10 9  CFU), and were randomly assigned (3:1 within each group) to receive vaccine or placebo. Vaccine and placebo were administered in phosphate-buffered saline contained 5% saccharose as 0·4 mL in each nostril. The primary outcome was solicited and unsolicited adverse events between day 0 and day 28. The analysis included all randomised participants who received a vaccine dose. Colonisation with BPZE1 was determined by repeatedly culturing nasopharyngeal aspirates at day 4, day 7, day 11, day 14, day 21, and day 28 after vaccination. Immunogenicity, as serum IgG and IgA responses were assessed at day 0, day 7, day 14, day 21, day 28, 6 months, and 12 months after vaccination. This trial is registered at Clinicaltrials.gov, NCT02453048.
FINDINGS


Between Sept 1, 2015, and Feb 3, 2016, 120 participants were assessed for eligibility, 48 of whom were enrolled and randomly assigned (3:1) to receive vaccine or placebo, with 12 participants each in a low-dose, medium-dose, and high-dose vaccine group. Adverse events between day 0 and day 28 were reported by one (8%, 95% CI 0-39) of 12 participants in both the placebo and low-dose groups, and two (17%; 2-48) of 12 participants in both the medium-dose and high-dose groups, including cough of grade 2 or more, oropharyngeal pain, and rhinorrhoea and nasal congestion. During this time, none of the participants experienced any spasmodic cough, difficulties in breathing, or adverse events following immunisation concerning vital signs. The tested doses of BPZE1 or placebo were well tolerated, with no apparent difference in solicited or unsolicited adverse events following immunisation between groups. Colonisation at least once after vaccination was observed in 29 (81%; 68-93) of 36 vaccinated participants. The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
INTERPRETATION


The tested vaccine was safe, induced a high colonisation rate in an adult population, and was immunogenic at all doses. These findings justify further clinical development of BPZE1 to ultimately be used as a priming vaccine for neonates or a booster vaccine for adolescents and adults, or both.
FUNDING


ILiAD Biotechnologies.",2020,"The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
","['Between Sept 1, 2015, and Feb 3, 2016, 120 participants were assessed for eligibility, 48 of whom were enrolled and randomly assigned (3:1) to receive', 'Healthy adults (18-32 years']","['vaccine or placebo', 'BPZE1 or placebo', 'Vaccine and placebo', 'live attenuated intranasal pertussis vaccine BPZE1', 'phosphate-buffered saline contained 5% saccharose as 0·4', 'placebo']","['spasmodic cough, difficulties in breathing, or adverse events', 'Safety and immunogenicity', 'Adverse events', 'Immunogenicity, as serum IgG and IgA responses', 'solicited and unsolicited adverse events', 'safety, colonisation, and immunogenicity', 'cough of grade 2 or more, oropharyngeal pain, and rhinorrhoea and nasal congestion', 'serum IgG and IgA titres', 'solicited or unsolicited adverse events', 'Colonisation']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]","[{'cui': 'C0277870', 'cui_str': 'Spasmodic cough'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C2363731', 'cui_str': 'Oropharyngeal pain'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",120.0,0.664209,"The tested vaccine doses were immunogenic, with increases in serum IgG and IgA titres against the four B pertussis antigens from baseline to 12 months.
","[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Jahnmatz', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France; Inria SISTM team, F-33405, Talence, France.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Al-Tawil', 'Affiliation': 'Karolinska Trial Alliance, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jann', 'Initials': 'J', 'LastName': 'Storsaeter', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Colin', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bauduin', 'Affiliation': 'University of Bordeaux, National Institute for Health and Medical Research (Inserm), Bordeaux Population Health Research Center, Bordeaux, France; University Hospital Centre CHU, Bordeaux, France; EUCLID/F-CRIN Clinical Trials Platform, Bordeaux, France.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Thalen', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Solovay', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Rubin', 'Affiliation': 'ILiAD Biotechnologies, New York, NY, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mielcarek', 'Affiliation': 'University of Lille, National Centre for Scientific Research (CNRS), National Institute for Health and Medical Research (Inserm), University Hospital Centre CHU Lille, Lille, France; Center for Infection and Immunity of Lille, Institut Pasteur de Lille, Lille, France.'}, {'ForeName': 'Rigmor', 'Initials': 'R', 'LastName': 'Thorstensson', 'Affiliation': 'Public Health Agency of Sweden, Solna, Sweden.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Locht', 'Affiliation': 'University of Lille, National Centre for Scientific Research (CNRS), National Institute for Health and Medical Research (Inserm), University Hospital Centre CHU Lille, Lille, France; Center for Infection and Immunity of Lille, Institut Pasteur de Lille, Lille, France. Electronic address: camille.locht@pasteur-lille.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30274-7']
1314,32675791,Gender Bias in Collaborative Medical Decision Making: Emergent Evidence.,"This initial, exploratory study on gender bias in collaborative medical decision making examined the degree to which physicians' reliance on a team member's patient care advice differs as a function of the gender of the advice giver. In 2018, 283 anesthesiologists read a brief, online clinical vignette and were randomly assigned to receive treatment advice from 1 of 8 possible sources (physician or nurse, man or woman, experienced or inexperienced). They then indicated their treatment decision, as well as the degree to which they relied upon the advice given.The results revealed 2 patterns consistent with gender bias in participants' advice taking. First, when treatment advice was delivered by an inexperienced physician, participants reported replying significantly more on the advice of a man versus a woman, F(1,61) = 4.24, P = .04. Second, participants' reliance on the advice of the woman physician was a function of her experience, F(1,62) = 6.96, P = .01, whereas reliance on the advice of the man physician was not, F(1,60) = 0.21, P = .65.These findings suggest women physicians, relative to men, may encounter additional hurdles to performing their jobs, especially at early stages in their careers. These hurdles are rooted in psychological biases of others, rather than objective features of cases or treatment settings. Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do with social category membership. The authors recommend institutions adopt policies and practices encouraging equal attention to advice, regardless of the source, to help ensure advice taking is a function of information quality rather than the attributes of the advice giver. Such policies and practices may help surface and implement diverse expert perspectives in collaborative medical decision making, promoting better and more effective patient care.",2020,"Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do social category membership.","['In 2018, 283 anesthesiologists read a brief, online clinical vignette']",['treatment advice from 1 of 8 possible sources (physician or nurse; man or woman; experienced or inexperienced'],[],"[{'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],,0.0207179,"Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do social category membership.","[{'ForeName': 'Erik G', 'Initials': 'EG', 'LastName': 'Helzer', 'Affiliation': ""E.G. Helzer is associate professor, Naval Postgraduate School, Monterey, California. C.G. Myers is assistant professor, Johns Hopkins Carey Business School and Johns Hopkins School of Medicine, Baltimore, Maryland. C. Fahim is a scientist, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada. K.M. Sutcliffe is professor, Johns Hopkins Carey Business School and Johns Hopkins School of Medicine, Baltimore, Maryland. J.H. Abernathy is associate professor of anesthesiology and critical care medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.""}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Myers', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fahim', 'Affiliation': ''}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sutcliffe', 'Affiliation': ''}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Abernathy', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003590']
1315,32650682,Endoscopic myringoplasty in pediatric patients: a comparison of cartilage graft push-through and underlay fascia graft techniques.,"BACKGROUND


Although myringoplasty is performed in pediatric patients, there is still no consensus on the graft material and surgerical procedure.
OBJECTIVE


To compare the short-and long- term graft take rates of the cartilage push-through and fascia graft techniques employed during pediatric myringoplasty.
MATERIALS AND METHODS


93 pediatric patients with perforation who underwent myringoplasty were randomized into the cartilage push-through and underlay fascia graft group. The outcomes evaluated were hearing gains, and graft success rates at 12 and 24 months.
RESULTS


The graft success rate was similar between two groups (95.7% vs 91.3%,  p  = .653) at postoperative 12th months, however, the graft success rate was significantly higher 91.5% for the cartilage graft group compared with 73.9% for the fascia group at postoperative 24th months. No significant between-group differences were observed pre- ( p  = .694) or post- ( p  = .812) operative ABG values or mean ABG gain ( p  = .745).The re-perforation rate in fascia group was significantly higher than that in push through group (19.05 vs. 4.44%). No middle ear cholesteatoma formation was found in either group.
CONCLUSION


Endoscopic cartilage push-through and underlay fascia graft myringoplasty afforded comparable hearing results in pediatric patients; however, the push-through technique without the elevation of a tympanomeatal flap exhibited better long-term graft success rate compared to underlay fascia graft.",2020,( p  = .745).The re-perforation rate in fascia group was significantly higher than that in push through group (19.05 vs. 4.44%).,"['93 pediatric patients with perforation who underwent myringoplasty', 'pediatric patients']","['cartilage push-through and underlay fascia graft group', 'Endoscopic myringoplasty', 'cartilage graft push-through and underlay fascia graft techniques']","['operative ABG values or mean ABG gain', 'graft success rate', 'hearing gains, and graft success rates', 'perforation rate', 'middle ear cholesteatoma formation']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0444455', 'cui_str': 'Underlay'}, {'cui': 'C0185473', 'cui_str': 'Grafting of fascia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0155490', 'cui_str': 'Cholesteatoma of middle ear'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",93.0,0.0802185,( p  = .745).The re-perforation rate in fascia group was significantly higher than that in push through group (19.05 vs. 4.44%).,"[{'ForeName': 'Zhengcai', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Department of Otorhinolaryngology, Affiliated Yiwu Hospital of Wenzhou Medical University (Yiwu Central Hospital), Yiwu City, China.'}]",Acta oto-laryngologica,['10.1080/00016489.2020.1787510']
1316,32666576,Clinical and cost effectiveness of a multi-professional medication reviews in care homes (CAREMED).,"OBJECTIVES


With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes was recommended. The aim of this study was to determine the effectiveness (falls reduction) and cost-effectiveness, of a multi-professional medication review (MPMR) service in care homes for older people.
METHOD


A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication reviews during the 12-month trial period. Target recruitment was 900 residents with 10% assumed loss to follow-up. Co-primary outcome measures were number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions.
KEY FINDINGS


A total of 826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure. The mean number of falls per resident per annum was 3.3 for intervention and 3.0 for control (P = 0.947). Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046). No significant difference identified in emergency hospital admissions or deaths. Estimated unadjusted incremental mean cost per resident was £374.26 higher in the intervention group.
CONCLUSIONS


In line with other medication review based interventions in care homes, two MPMRs improved medication appropriateness but failed to demonstrate improvements in clinical outcomes. From a health system perspective costs where estimated to increase overall and therefore a different model of medicines management is required.",2020,Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046).,"['826 care home residents were recruited with 324 lost to follow-up for at least one primary outcome measure', '900 residents with 10% assumed loss to follow-up', 'care homes for older people', ""A total of care homes in the East of England were cluster randomised to 'usual care' or two multi-professional (General practitioner, clinical pharmacist and care homes staff) medication"", 'With 70% of care home residents experiencing a medication error every day in the UK, better multi-professional working between medical practitioners, pharmacists and care homes']","['multi-professional medication review (MPMR) service', 'multi-professional medication']","['mean number of falls per resident per annum', 'effectiveness (falls reduction) and cost-effectiveness', 'emergency hospital admissions or deaths', 'number of falls and potentially inappropriate prescribing assessed by the Screening Tool of Older Persons Prescriptions']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184673', 'cui_str': 'Emergency hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C4305312', 'cui_str': ""STOPP - Screening Tool of Older Person's Prescriptions""}]",900.0,0.0886087,Each resident was found to be prescribed 0.69 (intervention) and 0.85 (control) potentially inappropriate medicines after 12 months (P = 0.046).,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Desborough', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Houghton', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Sach', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norfolk, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Viveca', 'Initials': 'V', 'LastName': 'Kirthisingha', 'Affiliation': 'Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Holland', 'Affiliation': 'Leicester Medical School, George Davies Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norfolk, UK.'}]",The International journal of pharmacy practice,['10.1111/ijpp.12656']
1317,32666638,Effect of a psychological nursing intervention on quality of life and cognitive function in patients with gastric carcinoma: A randomised controlled trial.,"AIM


We aimed to evaluate the effect of a psychological nursing intervention on quality of life (QoL) and cognitive function in patients with gastric carcinoma (GC) and proposed that the intervention might improve the QoL and cognitive function of GC patients.
METHODS


Gastric carcinoma patients were randomly assigned into two groups: (a) intervention group: receiving proper psychological nursing intervention; (b) control group: receiving conventional care.
RESULTS


The QoL and Montreal Cognitive Assessment (MoCA) scores at each dimensionality between the intervention group and the control group at baseline showed no significant differences (p > .05). However, after the 6-month psychological nursing intervention, 5 of 10 dimensionalities in QoL and 5 of 6 dimensionalities in MoCA showed statistically differences between the intervention group and the control group (p < .05). In comparison with the scores at baseline, the QoL scores measured after the 6-month psychological nursing intervention showed remarkable improvement in multiple dimensionalities in the intervention group, but only appetite loss improved in the control group. MoCA scores in multiple dimensionalities in the intervention group also exhibited obvious improvement compared with those in control group.
CONCLUSION


A psychological nursing intervention benefits the QoL and cognitive function in GC patients, indicating the importance of a psychological nursing intervention.",2020,"In comparison with the scores at baseline, the QoL scores measured after the 6-month psychological nursing intervention showed remarkable improvement in multiple dimensionalities in the intervention group, but only appetite loss improved in the control group.","['Gastric carcinoma patients', 'patients with gastric carcinoma (GC', 'patients with gastric carcinoma']","['intervention group: receiving proper psychological nursing intervention; (b) control group: receiving conventional care', 'psychological nursing intervention']","['multiple dimensionalities', 'QoL and Montreal Cognitive Assessment (MoCA) scores', 'quality of life (QoL) and cognitive function', 'MoCA scores', 'QoL scores', 'appetite loss', 'quality of life and cognitive function']","[{'cui': 'C0699791', 'cui_str': 'Carcinoma of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",,0.0231447,"In comparison with the scores at baseline, the QoL scores measured after the 6-month psychological nursing intervention showed remarkable improvement in multiple dimensionalities in the intervention group, but only appetite loss improved in the control group.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Lingshu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Forth Affiliated Hospital of Harbin Medical University, Harbin, China.'}]",European journal of cancer care,['10.1111/ecc.13292']
1318,32677772,The efficacy of gonadotropin-releasing hormone (GNRH) agonist before frozen embryo transfer in improving pregnancy outcome and decreasing miscarriage rate in hyperandrogenic polycystic ovary syndrome women: a randomized clinical trial.,"BACKGROUND


The hyper androgenic status is a major complication of polycystic ovarian syndrome (PCOS) that deteriorates endometrial function and increases miscarriage rate. This study was conducted to investigate the efficacy of GnRH agonist before frozen-thawed embryo transfer in improving pregnancy outcome in infertile women with PCOS.
METHODS


This single-blind, randomized controlled trial was performed at Dr Shariati hospital and Omid Fertility Clinic in Tehran, Iran. In the study were included 178 PCOS women. Patients were then divided into two groups of control and intervention. All women received the standard treatment for the preparation of the endometrial using estradiol valerate at dose of 6-8 mg/day. The intervention group also received diphereline, as GnRH agonist, at two doses, 8 weeks before starting the endometrial preparation.
RESULTS


Chemical pregnancy in intervention group was 47.7% compared to 35.6% in the control group, revealing no significant difference between two groups. No statistically significant difference was observed between two groups concerning clinical pregnancy rate (43.2% vs. 27.3%). However, rate of ongoing pregnancy was 42.0% in intervention group but 18.0% in the control group, suggesting a significant difference (P=0.001). The rate of miscarriage in the intervention group was 2.6% and in the control group was 33.3%, which was significantly lower (P=0.001).
CONCLUSIONS


It can be concluded that endometrial preparation using GnRH improves ongoing pregnancy and decreases miscarriage rate. It seems that reduction of androgen level in PCOS patients affects the endometrium and improves the receptivity and implantation of the embryo, resulting in better pregnancy outcomes by reducing the miscarriage rate.",2020,No statistically significant difference was observed between two groups concerning clinical pregnancy rate (43.2%vs. 27.3%).,"['infertile women with PCOS', 'Dr Shariati hospital and Omid Fertility Clinic in Tehran, Iran', '178 PCOS women were included', 'hyperandrogenic polycystic ovary syndrome women']","['gonadotropin-releasing hormone (GNRH) agonist before frozen embryo transfer', 'GnRH agonist before frozenthawed embryo transfer', 'estradiol valerate', 'diphereline, as GnRH agonist']","['clinical pregnancy rate', 'miscarriage rate', 'rate of miscarriage', 'rate of ongoing pregnancy']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",178.0,0.0986176,No statistically significant difference was observed between two groups concerning clinical pregnancy rate (43.2%vs. 27.3%).,"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Aghahoseini', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Alyasin', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Rashidi', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran - S.Rashidi.tums@gmail.com.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Samaei-Nouroozi', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hojatollah', 'Initials': 'H', 'LastName': 'Saeidi', 'Affiliation': 'Department of Biology and Embryology, Omid Fertility Center, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shabani-Nashtaei', 'Affiliation': 'Department of Gynecology and Obstetrics, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Minerva ginecologica,['10.23736/S0026-4784.20.04467-6']
1319,32673246,A Physical Activity and Diet Program Delivered by Artificially Intelligent Virtual Health Coach: Proof-of-Concept Study.,"BACKGROUND


Poor diet and physical inactivity are leading modifiable causes of death and disease. Advances in artificial intelligence technology present tantalizing opportunities for creating virtual health coaches capable of providing personalized support at scale.
OBJECTIVE


This proof of concept study aimed to test the feasibility (recruitment and retention) and preliminary efficacy of physical activity and Mediterranean-style dietary intervention (MedLiPal) delivered via artificially intelligent virtual health coach.
METHODS


This 12-week single-arm pre-post study took place in Adelaide, Australia, from March to August 2019. Participants were inactive community-dwelling adults aged 45 to 75 years, recruited through news stories, social media posts, and flyers. The program included access to an artificially intelligent chatbot, Paola, who guided participants through a computer-based individualized introductory session, weekly check-ins, and goal setting, and was available 24/7 to answer questions. Participants used a Garmin Vivofit4 tracker to monitor daily steps, a website with educational materials and recipes, and a printed diet and activity log sheet. Primary outcomes included feasibility (based on recruitment and retention) and preliminary efficacy for changing physical activity and diet. Secondary outcomes were body composition (based on height, weight, and waist circumference) and blood pressure.
RESULTS


Over 4 weeks, 99 potential participants registered expressions of interest, with 81 of those screened meeting eligibility criteria. Participants completed a mean of 109.8 (95% CI 1.9-217.7) more minutes of physical activity at week 12 compared with baseline. Mediterranean diet scores increased from a mean of 3.8 out of 14 at baseline, to 9.6 at 12 weeks (mean improvement 5.7 points, 95% CI 4.2-7.3). After 12 weeks, participants lost an average 1.3 kg (95% CI -0.1 to -2.5 kg) and 2.1 cm from their waist circumference (95% CI -3.5 to -0.7 cm). There were no significant changes in blood pressure. Feasibility was excellent in terms of recruitment, retention (90% at 12 weeks), and safety (no adverse events).
CONCLUSIONS


An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks. Future research examining artificially intelligent interventions at scale, and for other health purposes, is warranted.",2020,"An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks.","['Participants were inactive community-dwelling adults aged 45 to 75 years, recruited through news stories, social media posts, and flyers']","['Garmin Vivofit4 tracker', 'artificially intelligent chatbot, Paola, who guided participants through a computer-based individualized introductory session', 'physical activity and Mediterranean-style dietary intervention (MedLiPal']","['feasibility (based on recruitment and retention) and preliminary efficacy for changing physical activity and diet', 'blood pressure', 'body composition (based on height, weight, and waist circumference) and blood pressure', 'Mediterranean diet scores', 'waist circumference', 'physical activity, diet, and body composition', 'minutes of physical activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0648343,"An artificially intelligent virtual assistant-led lifestyle-modification intervention was feasible and achieved measurable improvements in physical activity, diet, and body composition at 12 weeks.","[{'ForeName': 'Carol Ann', 'Initials': 'CA', 'LastName': 'Maher', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Courtney Rose', 'Initials': 'CR', 'LastName': 'Davis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Rachel Grace', 'Initials': 'RG', 'LastName': 'Curtis', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Camille Elizabeth', 'Initials': 'CE', 'LastName': 'Short', 'Affiliation': 'Melbourne Centre for Behaviour Change, School of Psychological Sciences and School of Health Sciences, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Karen Joy', 'Initials': 'KJ', 'LastName': 'Murphy', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity, Clinical and Health Sciences, University of South Australia, Adelaide, Australia.'}]",JMIR mHealth and uHealth,['10.2196/17558']
1320,32687757,Gabapentin reduced drinking in patients with alcohol use disorder and alcohol withdrawal symptoms.,"SOURCE CITATION


Anton RF, Latham P, Voronin K, et al.  Efficacy of gabapentin for the treatment of alcohol use disorder in patients with alcohol withdrawal symptoms: a randomized clinical trial.  JAMA Intern Med. 2020;180:1-9. 32150232.",2020,Efficacy of gabapentin for the treatment of alcohol,"['patients with alcohol withdrawal symptoms', 'patients with alcohol use disorder and alcohol withdrawal symptoms']","['gabapentin', 'Gabapentin', 'alcohol']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",[],,0.0263875,Efficacy of gabapentin for the treatment of alcohol,"[{'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Rose', 'Affiliation': 'Boyle McCauley Health Centre/University of Alberta, Edmonton, Alberta, Canada (M.R.).'}]",Annals of internal medicine,['10.7326/ACPJ202007210-006']
1321,32687762,"In patients with CKD having CT with contrast media, no prehydration and prehydration did not differ for AKI.","SOURCE CITATION


Timal RJ, Kooiman J, Sijpkens YWJ, et al.  Effect of no prehydration vs sodium bicarbonate prehydration prior to contrast-enhanced computed tomography in the prevention of postcontrast acute kidney injury in adults with chronic kidney disease: the Kompas randomized clinical trial.  JAMA Intern Med. 2020;180:533-41. 32065601.",2020,"SOURCE CITATION


Timal RJ, Kooiman J, Sijpkens YWJ, et al.  ",['adults with chronic kidney disease'],['no prehydration vs sodium bicarbonate prehydration prior to contrast-enhanced computed tomography'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],,0.0187791,"SOURCE CITATION


Timal RJ, Kooiman J, Sijpkens YWJ, et al.  ","[{'ForeName': 'Neesh', 'Initials': 'N', 'LastName': 'Pannu', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada (N.P.).'}]",Annals of internal medicine,['10.7326/ACPJ202007210-009']
1322,32687763,Guselkumab safely improved clinical outcomes in biologic-naive patients with psoriatic arthritis.,"SOURCE CITATION


Mease PJ, Rahman P, Gottlieb AB, et al.  Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial.  Lancet. 2020;395:1126-36. 32178766.",2020,"Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial.  ","['biologic-naive patients with active psoriatic arthritis (DISCOVER-2', 'biologic-naive patients with psoriatic arthritis']","['Guselkumab', 'Guselkumab safely', 'placebo']",[],"[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.386249,"Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial.  ","[{'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Schattner', 'Affiliation': 'Hebrew University Hadassah, Jerusalem, Israel (A.S.).'}]",Annals of internal medicine,['10.7326/ACPJ202007210-007']
1323,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1324,32678434,The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants.,"BACKGROUND


In adults, oral iron doses increase plasma hepcidin (PHep) for 24 h, but not for 48 h, and there is a circadian increase in PHep over the day. Because high PHep decreases fractional iron absorption (FIA), alternate day iron dosing in the morning may be preferable to consecutive day dosing. Whether these effects occur in infants is uncertain.
OBJECTIVE


Using stable iron isotopes in Kenyan infants, we compared FIA from morning and afternoon doses and from consecutive, alternate (every second day) and every third day iron doses.
METHODS


In prospective studies, we measured and compared FIA and the PHep response from 1) meals fortified with a 12-mg iron micronutrient powder given in the morning or afternoon (n = 22); 2) the same given on consecutive or alternate days (n = 21); and 3) a 12-mg iron supplement given on alternate days or every third day (n = 24).
RESULTS


In total, 65.7% of infants were anemic. In study 1, PHep did not differ between morning and afternoon (P = 0.072), and geometric mean FIA[-SD, +SD](%) did not differ between the morning and afternoon doses [15.9 (8.9, 28.6) and 16.1 (8.7, 29.8), P = 0.877]. In study 2, PHep was increased 24 h after oral iron (P = 0.014), and mean FIA [±SD](%) from the baseline dose [23.3 (10.9)] was greater than that from the consecutive day dose (at 24 h) [20.1 (10.4); P = 0.042] but did not differ from the alternate day dose (at 48 h) [20.9 (13.4); P = 0.145]. In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
CONCLUSIONS


In Kenyan infants given 12 mg oral iron, morning and afternoon doses are comparably absorbed, dosing on consecutive days increases PHep and modestly decreases iron absorption compared with alternate day dosing, and dosing on alternate days or every third day does not increase PHep or decrease absorption. This trial was registered at clinicaltrials.gov as NCT02989311 and NCT03617575.",2020,"In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
",['Kenyan infants'],[],"['geometric mean FIA[-SD, +SD', 'iron absorption', 'mean FIA [±SD', 'PHep or decrease absorption', 'plasma hepcidin and iron absorption', 'fractional iron absorption (FIA']","[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",,0.224107,"In study 3, PHep was not increased 48 and 72 h after oral iron (P = 0.384), and the geometric mean FIA[-SD, +SD](%) from doses given at baseline, alternate days, and every third day did not differ [12.7 (7.3, 21.9), 13.8 (7.8, 24.2), and 14.8 (8.8, 24.8), respectively; P = 0.080].
","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Uyoga', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Mikulic', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Paganini', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Mwasi', 'Affiliation': 'Pediatric Department, Msambweni County Referral Hospital, Msambweni, Kenya.'}, {'ForeName': 'Nicole U', 'Initials': 'NU', 'LastName': 'Stoffel', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zeder', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Karanja', 'Affiliation': 'Public and Community Health Department, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Laboratory of Human Nutrition, ETH Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa174']
1325,32680754,"Efficacy of Adductor Canal Block Combined With Additional Analgesic Methods for Postoperative Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study.","BACKGROUND


The aim of this study is to evaluate the efficacy of adductor canal block (ACB) combined with additional analgesic methods in total knee arthroplasty (TKA) and investigate whether blocking the sensory nerves that are distributed in the posterior and lateral aspect of knee could improve postoperative pain control.
METHODS


Two hundred scheduled patients for TKA were randomly allocated into 4 groups: Group A received ACB combined with iPACK (interspace between the popliteal artery and capsule of the knee) block and lateral femoral cutaneous nerve block (LFCNB); Group B received ACB combined with iPACK block; Group C received ACB combined with LFCNB; and Group D received ACB only. Postoperative pain score was the main primary outcome. Secondary outcomes included the morphine consumption and analgesic duration. Other outcomes included knee range of motion, quadriceps strength, ambulation, Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index physical function, timed up and go (TUG) test, and complications.
RESULTS


Groups A, B, and C had lower postoperative pain scores within 12 hours at rest and 8 hours with activity than Group D (P < .05). In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01). Group A had the longest analgesic duration (19.21 ± 3.22 hours) among all groups. There were no significant differences among the groups in terms of mobility and complication after surgery.
CONCLUSION


Combining ACB with both iPACK and LFCNB is an effective method for decreasing early postoperative pain in TKA without increasing the complications or affecting the early rehabilitation.",2020,"In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01).","['total knee arthroplasty (TKA', 'Total Knee Arthroplasty', 'Two hundred scheduled patients for TKA']","['ACB combined with iPACK (interspace between the popliteal artery and capsule of the knee) block and lateral femoral cutaneous nerve block (LFCNB); Group B received ACB combined with iPACK block', 'Adductor Canal Block Combined With Additional Analgesic Methods', 'adductor canal block (ACB) combined with additional analgesic methods', 'ACB combined with LFCNB', 'iPACK and LFCNB']","['mobility and complication', 'knee range of motion, quadriceps strength, ambulation, Knee Society Score, Western Ontario and McMaster Universities Osteoarthritis Index physical function, timed up and go (TUG) test, and complications', 'longest analgesic duration', 'postoperative pain scores', 'morphine consumption', 'early postoperative pain', 'morphine consumption and analgesic duration', 'Postoperative pain score']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",200.0,0.219531,"In addition, Group A had lower morphine consumption than both Group C (P < .05) and Group D (P < .01).","[{'ForeName': 'Donghai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alqwbani', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Liao', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.060']
1326,32674103,[Lost in Transition: Is Early Respiratory Support in Newborn Infants the Best Option?],"BACKGROUND


Late preterm and term newborns with respiratory distress are increasingly treated with non-invasive ventilation (NIV) including nasal high-flow or continuous positive airway pressure. For infants with mild distress, NIV may be unnecessary.
OBJECTIVES


We speculated that treatment with supplemental oxygen (SO) prior to NIV could help clinicians select infants for NIV treatment, and examined this hypothesis using data from a recently completed trial.
METHOD


Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial. Infants born at ≥36 weeks' gestation were categorized by whether they were receiving SO prior to randomization. The 2 groups were compared for illness severity (indicated by treatment failure at 72 h, mechanical ventilation, need for up-transfer, SO requirement post-randomization, and length of time receiving respiratory support), use of selected medical interventions (antibiotics, intravenous fluids), and breastfeeding at discharge.
RESULTS


Analysis included 380 infants. Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%). Most infants in both groups received intravenous fluids (93 and 98%) and antibiotics (81 and 93%); the rate of full breastfeeding was low in both groups (51 and 45%).
CONCLUSIONS


Late preterm and term newborn infants without SO requirement at the time of commencing NIV for respiratory distress are at lower risk of requiring treatment escalation. Close observation of these infants (watch and wait strategy) may avoid unnecessary treatment.",2020,"Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%).","[""Infants born at ≥36 weeks' gestation"", 'Late preterm and term newborns with respiratory distress', 'Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial', '380 infants', 'Newborn Infants']",['supplemental oxygen (SO'],"['severe illness; lower rates of treatment failure', 'rate of full breastfeeding', 'mechanical ventilation']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319693', 'cui_str': '380'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",380.0,0.196799,"Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buckmaster', 'Affiliation': 'Women, Children and Families, Central Coast Local Health District, Gosford, New South Wales, Australia, agbuck@ozemail.com.au.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Arnolda', 'Affiliation': 'Australian Institute for Healthcare Innovation, Macquarie University, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Clayton, Victoria, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",Neonatology,['10.1159/000508554']
1327,32673262,Implementing mHealth Interventions in a Resource-Constrained Setting: Case Study From Uganda.,"BACKGROUND


Mobile health (mHealth) interventions are becoming more common in low-income countries. Existing research often overlooks implementation challenges associated with the design and technology requirements of mHealth interventions.
OBJECTIVE


We aimed to characterize the challenges that we encountered in the implementation of a complex mHealth intervention in Uganda.
METHODS


We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation. We incorporated digital fingerprinting for patient identification in both study arms and automated SMS messages in the intervention arm only. A local research team systematically documented challenges to implementation in biweekly site visit reports, project management reports, and minutes from biweekly conference calls. We then classified these challenges using the Consolidated Framework for Implementation Research (CFIR).
RESULTS


We identified challenges in three principal CFIR domains: (1) intervention characteristics, (2) inner setting, and (3) characteristics of implementers. The adaptability of the app to the local setting was limited by software and hardware requirements. The complexity and logistics of implementing the intervention further hindered its adaptability. Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation. After experiencing technological failures, their trust in the technology declined along with their use of it. Finally, complex data structures impeded the development and execution of a data management plan that would allow for articulation of goals and provide timely feedback to study staff, CHWs, and participants.
CONCLUSIONS


mHealth technologies have the potential to make delivery of public health interventions more direct and efficient, but we found that a lack of adaptability, excessive complexity, loss of trust among end users, and a lack of effective feedback systems can undermine implementation, especially in low-resource settings where digital services have not yet proliferated. Implementers should anticipate and strive to avoid these barriers by investing in and adapting to local human and material resources, prioritizing feedback from end users, and optimizing data management and quality assurance procedures.
TRIAL REGISTRATION


Pan-African Clinical Trials Registration PACTR201509000877140; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=877.",2020,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"['community health workers (CHWs', 'We customized a commercial mobile survey app to facilitate a two-arm household-randomized, controlled trial of home-based tuberculosis (TB) contact investigation', 'Uganda']",[],[],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]",[],[],,0.074366,Study staff reported that community health workers (CHWs) were enthusiastic regarding the use of technology to enhance TB contact investigation during training and the initial phase of implementation.,"[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Meyer', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Armstrong-Hough', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Babirye', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mark', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ayakaka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Makerere University, Kampala, Uganda.'}, {'ForeName': 'J Lucian', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States.'}]",JMIR mHealth and uHealth,['10.2196/19552']
1328,32673267,Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention.,"BACKGROUND


Multicomponent family interventions underline current best practice in childhood obesity treatment. Mobile health (mHealth) adjuncts that address eating and physical activity behaviors have shown promise in clinical studies.
OBJECTIVE


This study aimed to describe process methods for applying an mHealth intervention to reduce the rate of eating and monitor physical activity among children with obesity.
METHODS


The study protocol was designed to incorporate 2 mHealth apps as an adjunct to usual care treatment for obesity. Children and adolescents (aged 9-16 years) with obesity (BMI ≥98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland. Eligible participants and their parents received information leaflets, and informed consent and assent were signed. Participants completed 2 weeks of baseline testing, including behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level using a smart watch and the myBigO smartphone app. Thereafter, participants were randomized to the (1) intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care) groups. Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied. At the end of a 4-week treatment period, participants repeated the 2-week testing period. Process evaluation measures included recruitment, study retention, fidelity parameters, acceptability, and user satisfaction.
RESULTS


A total of 20 participants were enrolled in the study. A web-based randomization system assigned 8 participants to the intervention group and 12 participants to the control group. Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%). Intervention participants undertook a median of 1.0 training meal using Mandolean (25th centile 0, 75th centile 9.3), which represented 19.2% of planned intervention exposure. Only 50% (9/18) of participants with smart watches logged physical activity data. Significant differences in psychosocial profile were observed at baseline between the groups. The Child Behavior Checklist (CBCL) mean total score was 71.7 (SD 3.1) in the intervention group vs 57.6 (SD 6.6) in the control group, t-test P<.001, and also different among those who completed the planned protocol compared with those who withdrew early (CBCL mean total score 59.0, SD 9.3, vs 67.9, SD 5.6, respectively; t-test P=.04).
CONCLUSIONS


A high early attrition rate was a key barrier to full study implementation. Perceived task burden in combination with behavioral issues may have contributed to attrition. Low exposure to the experimental intervention was explained by poor acceptability of Mandolean as a home-based tool for treatment. Self-monitoring using myBigO and the smartwatch was acceptable among this cohort. Further technical and usability studies are needed to improve adherence in our patient group in the tertiary setting.",2020,"Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%).","['children with obesity', 'A total of 20 participants were enrolled in the study', 'Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied', 'Pediatric Obesity Treatment', 'Children and adolescents (aged 9-16 years) with obesity (BMI ≥98th centile) were recruited in person from a weight management service at a tertiary health care center in the Republic of Ireland']","['intervention (usual clinical care+Mandolean training to reduce the rate of eating) or (2) control (usual clinical care', 'Multicomponent Intervention']","['recruitment, study retention, fidelity parameters, acceptability, and user satisfaction', 'Attrition rates', 'rate of eating and monitor physical activity', 'behavioral and quality of life questionnaires, anthropometry, rate of eating by Mandolean, and physical activity level', 'psychosocial profile', 'Child Behavior Checklist (CBCL) mean total score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0668364,"Attrition rates were higher among the participants in the intervention group (5/8, 63%) than those in the control group (3/12, 25%).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Browne', 'Affiliation': 'School Public Health, Physiotherapy & Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'M-Tahar', 'Initials': 'MT', 'LastName': 'Kechadi', 'Affiliation': 'Insight Centre for Data Analytics, School of Computer Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'School of Sociology, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Mckenzie', 'Initials': 'M', 'LastName': 'Dow', 'Affiliation': 'School Public Health, Physiotherapy & Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Tully', 'Affiliation': 'Division of Population Health Sciences, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Gerardine', 'Initials': 'G', 'LastName': 'Doyle', 'Affiliation': 'UCD Michael Smurfit Graduate Business School, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': ""O'Malley"", 'Affiliation': 'Division of Population Health Sciences, School of Physiotherapy, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",JMIR mHealth and uHealth,['10.2196/16925']
1329,32674535,Changes in bench press performance and throwing velocity after strength-oriented and ballistic resistance training programs.,"BACKGROUND


This study aimed to compare the effect of two upper-body resistance training programs (strength-oriented vs. ballistic) on bench press (BP) performance and handball throwing velocity (HTV).
METHODS


Thirty resistance-trained males were randomly assigned to a strength-oriented training group (STG) or a ballistic training group (BTG). The study consisted of 11 sessions: 2 pre-tests (week 1), 8 training sessions (weeks 2-5), and 1 post-test (week 6). The STG performed the BP at the 70-90% of the one-repetition maximum (1RM), and the BTG the BP throw at the 40% of 1RM. BP performance (BP 1RM and maximum velocity achieved against 20 kg [BP20]) and HTV were assessed before and after training.
RESULTS


The STG enhanced BP 1RM (effect size [ES]=0.24) but not BP20 (ES=0.21) or HTV (ES=0.10). The BTG enhanced BP20 (ES=0.63) but not BP1RM (ES=0.27) or HTV (ES=0.02). HTV was not significantly correlated with the BP 1RM (r≤0.181) or BP20 (r≤0.220).
CONCLUSIONS


These results indicate that a short-term RT program based exclusively on the BP exercise performed against either heavy (strength-oriented) or light loads (ballistic) is not effective to increase HTV in resistance-trained men with little handball experience.",2020,The STG enhanced BP 1RM (effect size [ES] = 0.24) but not BP20 (ES = 0.21) or HTV (ES = 0.10).,['Thirty resistance-trained males'],"['two upper-body resistance training programs (strength-oriented vs. ballistic', 'strength-oriented training group (STG) or a ballistic training group (BTG', 'BP exercise performed against either heavy (strength-oriented) or light loads (ballistic']","['STG enhanced BP 1RM', 'BP performance (BP 1RM and maximum velocity achieved against 20 kg [BP20]) and HTV', 'bench press (BP) performance and handball throwing velocity (HTV', 'BP 1RM', 'HTV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]",,0.0261405,The STG enhanced BP 1RM (effect size [ES] = 0.24) but not BP20 (ES = 0.21) or HTV (ES = 0.10).,"[{'ForeName': 'Jesualdo', 'Initials': 'J', 'LastName': 'Cuevas-Aburto', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción (UCSC), Concepción, Chile.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'Faculty of Sport and Physical Education, The Research Centre, University of Belgrade, Belgrade, Serbia - jan.danica@gmail.com.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Chirosa-Ríos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción (UCSC), Concepción, Chile.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11011-9']
1330,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1331,32676977,"A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.","BACKGROUND


The delta opioid receptor (DOR) has been identified as a therapeutic target for migraine, with DOR agonists exhibiting low abuse potential compared with conventional µ-opioid agonists. TRV250 is a novel small molecule agonist of the DOR that is preferentially selective for G-protein signaling, with relatively little activation of the β-arrestin2 post-receptor signaling pathway. This selectivity provides reduced susceptibility to proconvulsant activity seen with non-selective DOR agonists. TRV250 significantly reduced nitroglycerin-evoked hyperalgesia in rodents, indicating a potential utility in acute migraine without the risk of seizure activity or abuse potential.
OBJECTIVE


This trial evaluated the safety, tolerability, and pharmacokinetics of ascending dose levels of TRV250 administered subcutaneously (SC) and the relative bioavailability of TRV250 administered orally compared with SC administration.
METHODS


This was a two-part, single ascending dose study. Part A included four cohorts of healthy adults (N = 38). Each cohort was dosed on three occasions (placebo and two different dose levels of TRV250, allocated in randomized order and administered by SC route). In Part B, a single cohort of nine subjects received an oral dose of either TRV250 (n = 7) or placebo (n = 2) in a fed or fasted state. Serial blood samples were obtained for pharmacokinetic determination across a 24-h post-dose period. Safety assessments included clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing.
RESULTS


TRV250 was well tolerated. There were no serious adverse events (SAEs), and all AEs were mild in severity. Injection-site reactions and headache were the most common AEs. One subject was withdrawn from the study due to a TRV250-related AE of postural orthostatic tachycardia. There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects. No subject experienced abnormalities in EEGs or experienced a change from baseline in heart-rate-corrected QT interval (QTcF) > 60 ms, or an absolute QTcF interval > 480 ms at any post-dosing observation. Peak and total plasma exposure to TRV250 increased in a dose-proportional manner following 0.1-30 mg SC doses, with the mean half-life ranging from 2.39 to 3.76 h. Oral bioavailability of TRV250 ranged from 14% (fasting) to 19% (fed) relative to SC dosing, while administration with food increased the AUC but decreased the rate of absorption as reflected by a modest delay in median time to maximum concentration and a slight reduction in maximum concentration.
CONCLUSION


The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine.",2020,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","['Part A included four cohorts of healthy adults (N\u2009=\u200938', 'Healthy Subjects']","['occasions (placebo', 'Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist', 'TRV250 administered subcutaneously (SC', 'TRV250', 'placebo']","['clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing', 'absolute QTcF interval\u2009', 'tolerated', 'rate of absorption', 'safety, tolerability, and pharmacokinetics', 'Peak and total plasma exposure to TRV250', 'physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs', 'serious adverse events (SAEs', 'nitroglycerin-evoked hyperalgesia', 'heart-rate-corrected QT interval (QTcF)\u2009']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.101361,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena, Inc., 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA. mfossler@trevena.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Schmith', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lohmer', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Scientific Operations and Alliance Management, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Arscott', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'James', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}]",CNS drugs,['10.1007/s40263-020-00738-0']
1332,32681063,Music therapy and retinopathy of prematurity screening: using recorded maternal singing and heartbeat for post exam recovery.,"OBJECTIVE


Explore a music therapy (MT) intervention to support infant recovery post retinopathy of prematurity (ROP) exam.
STUDY DESIGN


Prospective, double-masked, randomized, parallel group study of 100 preterm infants exposed to MT (recorded maternal singing/heartbeat) or standard care (SC). Premature Infant Pain Profile (PIPP) measured at: baseline, during the exam, and 1 and 5 min post exam.
RESULTS


Recovery PIPP scores were less with MT vs. SC, but statistical significance not achieved (Mean ± sd: MT 1 min [5.81 ± 2.93] and 5 min [3.91 ± 1.73] vs. SC 1 min [6.40 ± 2.78] and 5 min [4.76 ± 2.07], p = 0.07). Recovery PIPP sores were significantly higher with SC compared to MT when eye exams were longer (p = 0.049) or when exams were more painful (p = 0.04).
CONCLUSION


Recorded maternal singing and heartbeat can support recovery post ROP exam. For longer/more painful ROP exams, MT may be more effective than SC promoting recovery post exam.",2020,"Recovery PIPP sores were significantly higher with SC compared to MT when eye exams were longer (p = 0.049) or when exams were more painful (p = 0.04).
",['100 preterm infants exposed to MT (recorded maternal singing/heartbeat) or standard care (SC'],"['Music therapy and retinopathy of prematurity screening', 'music therapy (MT) intervention']","['Recovery PIPP sores', 'Recovery PIPP scores', 'Premature Infant Pain Profile (PIPP']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.10605,"Recovery PIPP sores were significantly higher with SC compared to MT when eye exams were longer (p = 0.049) or when exams were more painful (p = 0.04).
","[{'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Corrigan', 'Affiliation': 'Orlando Health Winnie Palmer Hospital for Women & Babies, Alexander Center for Neonatology, Orlando, FL, USA. maxwell.corrigan@orlandohealth.com.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Keeler', 'Affiliation': 'Orlando Health Winnie Palmer Hospital for Women & Babies, Alexander Center for Neonatology, Orlando, FL, USA.'}, {'ForeName': 'Harriet D', 'Initials': 'HD', 'LastName': 'Miller', 'Affiliation': 'Orlando Health Winnie Palmer Hospital for Women & Babies, Alexander Center for Neonatology, Orlando, FL, USA.'}, {'ForeName': 'Bertha A', 'Initials': 'BA', 'LastName': 'Ben Khallouq', 'Affiliation': 'Orlando Health Arnold Palmer Hospital for Children, Orlando, FL, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Fowler', 'Affiliation': 'Orlando Health, Center for Nursing Research, Orlando, FL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0719-9']
1333,32673497,Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF.,"BACKGROUND


In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), the sodium-glucose cotransporter 2 inhibitor dapagliflozin reduced the risk of worsening heart failure and death in patients with heart failure and reduced ejection fraction. We examined the efficacy and tolerability of dapagliflozin in relation to background diuretic treatment and change in diuretic therapy after randomization to dapagliflozin or placebo.
METHODS


We examined the effects of study treatment in the following subgroups: no diuretic and diuretic dose equivalent to furosemide <40, 40, and >40 mg daily at baseline. We examined the primary composite end point of cardiovascular death or a worsening heart failure event and its components, all-cause death and symptoms.
RESULTS


Of 4616 analyzable patients, 736 (15.9%) were on no diuretic, 1311 (28.4%) were on <40 mg, 1365 (29.6%) were on 40 mg, and 1204 (26.1%) were taking >40 mg. Compared with placebo, dapagliflozin reduced the risk of the primary end point across each of these subgroups: hazard ratios were 0.57 (95% CI, 0.36-0.92), 0.83 (95% CI, 0.63-1.10), 0.77 (95% CI, 0.60-0.99), and 0.78 (95% CI, 0.63-0.97), respectively ( P  for interaction=0.61). The hazard ratio in patients taking any diuretic was 0.78 (95% CI, 0.68-0.90). Improvements in symptoms and treatment toleration were consistent across the diuretic subgroups. Diuretic dose did not change in most patients during follow-up, and mean diuretic dose did not differ between the dapagliflozin and placebo groups after randomization.
CONCLUSIONS


The efficacy and safety of dapagliflozin were consistent across the diuretic subgroups examined in DAPA-HF. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03036124.",2020,Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  ,"['Patients with Heart Failure and Reduced Ejection Fraction in DAPA-HF', '4616 analyzable patients, 736 (15.9%) were on no diuretic, 1311 (28.4%) were on <40mg, 1365 (29.6%) on 40 mg and 1204 (26.1%) of patients were taking >40 mg', 'patients with heart failure and reduced ejection fraction']","['dapagliflozin or placebo', 'dapagliflozin', 'DAPA-HF', 'SGLT2 inhibitor dapagliflozin', 'Dapagliflozin and Diuretic', 'diuretic, diuretic dose equivalent to furosemide <40mg daily, 40mg daily and >40mg daily at baseline', 'placebo, dapagliflozin', 'dapagliflozin and placebo']","['cardiovascular (CV) death or a worsening HF event, its components, all-cause death and symptoms', 'Improvement in symptoms and treatment toleration', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",4616.0,0.120661,Diuretic dose did not change in most patients during follow-up and mean diuretic dose did not differ between the dapagliflozin and placebo group after randomization.  ,"[{'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Jackson', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Dewan', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis (I.S.A.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bělohlávek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital and 1st Faculty of Medicine, Charles University, Prague, Czech Republic (J.B.).'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, The Netherlands (R.A.d.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg-Saar, Germany (M.B.).'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Quantitative Clinical Pharmacology, IMED Biotech Unit, Astra-Zeneca, Gaithersburg, MD (D.W.B.).'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, India (V.K.C.).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': '5th Department of Internal Medicine, Comenius University in Bratislava, Slovakia (A.D.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Cardiovascular, Renal and Metabolism Translational Medicines Unit, Early Clinical Development, IMED Biotech Unit (P.J.G.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cumming School of Medicine and Libin Cardiovascular Institute, University of Calgary, AB, Canada (J.G.W.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City (M.N.K.).""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindholm', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg, Sweden (C.E.A.L.).'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Argentina (F.A.M.).'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, QC, Canada (E.O.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D (O.B., A.M.L., D.L., M.S.), AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (M.S.S., S.D.S.).""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia (S.T.).'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, ON, Canada (S.V.).""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, UK (A.M.J., P.D., K.F.D., P.S.J., J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.047077']
1334,32673517,Splanchnic Venous Compression Enhances the Effects of ß-Blockade in the Treatment of Postural Tachycardia Syndrome.,"Background Splanchnic venous pooling induced by upright posture triggers a compensatory increase in heart rate (HR), a response that is exaggerated in patients with postural tachycardia syndrome. To assess whether abdominal compression attenuates orthostatic tachycardia and improves symptoms, 18 postural tachycardia syndrome patients (32±2 years) were randomized to receive either abdominal compression (40 mm Hg applied with an inflatable binder ≈2 minutes before standing) or propranolol (20 mg) in a placebo-controlled, crossover study. Methods and Results Systolic blood pressure, HR, and symptoms were assessed while seated and standing, before and 2 hours postdrug. As expected, propranolol decreased standing HR compared with placebo (81±2 versus 98±4 beats per minute;  P <0.001) and was associated with lower standing systolic blood pressure (93±2 versus 100±2 mm Hg for placebo;  P =0.002). Compression had no effect on standing HR (96±4 beats per minute) but increased standing systolic blood pressure compared with placebo and propranolol (106±2 mm Hg;  P <0.01). Neither propranolol nor compression improved symptoms compared with placebo. In 16 patients we compared the combination of abdominal compression and propranolol with propranolol alone. The combination had no additional effect on standing HR (81±2 beats per minute for both interventions) but prevented the decrease in standing systolic blood pressure produced by propranolol (98±2 versus 93±2 mm Hg for propranolol;  P =0.029), and significantly improved total symptom burden (-6±2 versus -1±2 for propranolol;  P =0.041). Conclusions Splanchnic venous compression alone did not improve HR or symptoms but prevented the blood pressure decrease produced by propranolol. The combination was more effective in improving symptoms than either alone. Splanchnic venous compression can be a useful adjuvant therapy to propranolol in postural tachycardia syndrome. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00262470.",2020,"As expected, propranolol decreased standing HR compared with placebo (81±2 versus 98±4 beats per minute;  P <0.001) and was associated with lower standing systolic blood pressure (93±2 versus 100±2 mm ","['Postural Tachycardia Syndrome', '18 postural tachycardia syndrome patients (32±2\xa0years', 'patients with postural tachycardia syndrome']","['placebo and propranolol', 'Splanchnic venous compression', 'propranolol with propranolol alone', 'abdominal compression (40\xa0mm', 'abdominal compression attenuates orthostatic tachycardia', 'propranolol', 'placebo']","['HR or symptoms', 'total symptom burden', 'blood pressure', 'Systolic blood pressure, HR, and symptoms', 'standing systolic blood pressure', 'heart rate (HR', 'standing HR']","[{'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1303018', 'cui_str': 'Standing systolic blood pressure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",,0.169521,"As expected, propranolol decreased standing HR compared with placebo (81±2 versus 98±4 beats per minute;  P <0.001) and was associated with lower standing systolic blood pressure (93±2 versus 100±2 mm ","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Smith', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Satish R', 'Initials': 'SR', 'LastName': 'Raj', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Gamboa', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Cyndya A', 'Initials': 'CA', 'LastName': 'Shibao', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Bonnie K', 'Initials': 'BK', 'LastName': 'Black', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Peltier', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Sachin Y', 'Initials': 'SY', 'LastName': 'Paranjape', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Biaggioni', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Okamoto', 'Affiliation': 'Vanderbilt Autonomic Dysfunction Center Vanderbilt University School of Medicine Nashville TN.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016196']
1335,32682277,Effects of repeated exposure to fearful and disgusting stimuli on fear renewal in blood-injection-injury phobia.,"Although exposure is effective for blood-injection-injury (BII) phobia, fear often returns after treatment. While disgust has been implicated in BII phobia, its effects on fear renewal are unclear. To address this knowledge gap, the present study examined the effect of repeated video exposure to fearful and disgusting stimuli in multiple contexts on fear renewal in BII phobia. Individuals with BII phobia (N = 57) were randomized to Disgust-Specific Exposure (DSE) which included exposure to disgusting but threat-irrelevant stimuli (i.e., vomit), Fear-Specific Exposure (FSE) which included exposure to threat-relevant stimuli (i.e., injections), or General Negative Exposure (GNE) which included exposure designed to elicit negative affect (i.e., tornado) without being disgusting or threat-relevant. During session one, participants watched a pre- and post-exposure assessment injection video (""pre/post assessment""), and a novel injection video after exposure to assess renewal effects (""novel 1""). Participants came in one week later to rate the same videos, and a new injection video (""novel 2""). For week one outcomes, comparisons of covariate adjusted means indicated the fear-specific group reported significantly lower levels of anxiety than the general-negative group to the post-exposure and novel 1 stimulus. When presented with the post-exposure stimuli during week two, the disgust-specific and fear-specific groups reported significantly lower levels of anxiety than the general negative group. The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two. These findings suggest that repeated exposure to threat-relevant cues in multiple contexts does reduce the return of anxiety. However, repeated exposure to disgusting but threat irrelevant stimuli may also produce some therapeutic effects. The implications of the integration of disgust-relevant processes into exposure-based treatment of BII phobia are discussed.",2020,The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two.,"['Individuals with BII phobia (N = 57', 'blood-injection-injury phobia', 'multiple contexts on fear renewal in BII phobia']","['Disgust-Specific Exposure (DSE) which included exposure to disgusting but threat-irrelevant stimuli (i.e., vomit), Fear-Specific Exposure (FSE) which included exposure to threat-relevant stimuli (i.e., injections), or General Negative Exposure', 'repeated exposure to fearful and disgusting stimuli', 'pre- and post-exposure assessment injection video (""pre/post assessment']","['return of anxiety', 'levels of anxiety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",57.0,0.00929875,The fear-specific group also reported significantly lower levels of anxiety than the disgust-specific and general-negative groups when presented with novel 1 and novel 2 stimuli at week two.,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Jessup', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tomarken', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Viar-Paxton', 'Affiliation': 'Vanderbilt University, United States.'}, {'ForeName': 'Bunmi O', 'Initials': 'BO', 'LastName': 'Olatunji', 'Affiliation': 'Vanderbilt University, United States. Electronic address: olubunmi.o.olatunji@vanderbilt.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102272']
1336,33069063,Reliability of ultrasound measurement for isolated control of the transversus abdominis muscle during abdominal hollowing: A secondary analysis.,"Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH) are conducted at the maximum AH, which would be unable to evaluate isolated control of the TrA to the internal or external oblique muscles (outer muscles). The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US. The datasets of two follow-ups were analyzed with 1-week interval of a wait-and-see control group comprising 20 participants with LBP in a randomized controlled trial. The primary measures were; % change in the thickness of the TrA at 1 cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia. The measurement time points were immediately before AH during resting and when outer muscle thickness above 1 cm lateral to the muscle-fascia junction of the TrA increased by 10%. Consequently, five repetitions were required to obtain a stable mean value and good reliability (intraclass correlation coefficient [ICC] (1,5)  = 0.65-0.68 for the % change, and 0.84-0.88 for the change in horizontal distance; ICC (2,5)  = 0.82 for the % change, and 0.93 for the change in horizontal distance).",2020,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,[],"['ICC', 'Ultrasonography (US) measurements of the transversus abdominis muscle (TrA) during abdominal hollowing (AH']","['thickness of the TrA at 1\xa0cm lateral to the muscle-fascia junction of the TrA, and changes in horizontal distance of the superior edge of the TrA fascia']",[],"[{'cui': 'C0242349', 'cui_str': 'Immunocytochemical procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]",20.0,0.0294516,The present study aimed to establish a reliable method to evaluate the skills of isolated control of the TrA to the outer muscles using US.,"[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takasaki', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan. Electronic address: physical.therapy.takasaki@gmail.com.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Physical Therapy, Saitama Prefectural University, Koshigaya, Saitama, Japan.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102476']
1337,33069106,Brief mindfulness training for smoking cessation in Chinese women in workplaces: A pilot randomized controlled trial.,"INTRODUCTION


Mindfulness training (MT) has shown preliminary efficacy as a behavioral treatment for smoking cessation. We examined the effect of a brief-MT intervention on smoking cessation for Chinese women in workplaces in Hong Kong, China.
METHODS


In this pilot randomized controlled trial, 213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n = 114) or control (n = 99) groups. Participants in both groups received a self-help booklet. Participants in the intervention group additionally attended 2 sessions of a brief-MT workshop. The primary outcome was self-reported 7-day point-prevalence abstinence (PPA) at 6 months. Secondary outcomes were biochemically validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/mL) and smoking reduction at 6 months. Analyses were done by intention to treat. We conducted a post-trial qualitative evaluation on participants in the intervention group (n = 14). Data were analyzed thematically.
RESULTS


At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61). Very few participated in biochemical validation (n = 17), and validated abstinence and smoking reduction rates showed no significant difference (5.3% vs. 11.1%, P = 0.12 and 20.2% vs. 20.2%, P = 1.00, respectively). A posteriori analysis showed that brief-MT participants who were psychologically engaged with the intervention had greater 6-month PPA. Qualitative evaluation showed brief-MT reduced stress but its effectiveness was restrained by the insufficient home practice.
CONCLUSIONS


This pilot trial on a brief-MT intervention for smoking cessation on Chinese women in workplaces showed feasibility, but improving compliance is needed to maximize the efficacy in future fully powered trials.",2020,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","['Chinese women in workplaces', 'participants in the intervention group (n\xa0=\xa014', 'Chinese women in workplaces in Hong Kong, China', '213 daily smokers were recruited from workplaces and computer-randomized into the intervention (n\xa0=\xa0114) or control (n\xa0=\xa099) groups']","['self-help booklet', 'Mindfulness training (MT', 'MT intervention', 'brief-MT intervention', 'Brief mindfulness training']","['validated abstinence and smoking reduction rates', 'smoking reduction', '6-month PPA', 'smoking cessation', '7-day PPA', 'self-reported 7-day point-prevalence abstinence (PPA', 'salivary cotinine']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}]",213.0,0.102459,"At 6-month follow-up, self-reported 7-day PPA were similar between the intervention and control groups (18.4% vs. 21.2%; P = 0.61).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Oi Sze', 'Initials': 'OS', 'LastName': 'Lau', 'Affiliation': 'The Lok Sin Tong Benevolent Society Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jung Jae', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'William Ho-Cheung', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jojo Yan Yan', 'Initials': 'JYY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, University of Hong Kong, Hong Kong SAR, China. Electronic address: mpwang@hku.hk.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106677']
1338,33069109,Behavioral modification decreases approach bias in young adults with internet gaming disorder.,"BACKGROUND


One of the key symptoms of Internet gaming disorder is the impulsive pursuit of Internet games, which causes individuals with this disorder to have a tendency to approach gaming cues. Dual processing theory states that this approach bias is caused by the suppression of reflective processing and the hyperactivity of impulsive processing. Therefore, reverse modification training for approach bias can suppress impulsive processing, thereby reducing or treating the disorder.
METHOD


In this study, 48 individuals with Internet gaming disorder were selected and randomly assigned to the following two groups: the experimental group and the control group. The 24 participants in the experimental group received a 4-day stimulus-response compatibility (SRC) approach bias modification treatment, whereas the 24 participants in the control group received a corresponding SRC pseudomodification training.
RESULTS


The approach response time of both groups to the gaming cues was significantly shorter than that to the neutral cues at baseline. After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased. However, the control group subjects did not show these effects.
CONCLUSION


The current results imply that individuals with Internet gaming disorder show approach bias toward Internet gaming cues, and SRC reverse modification training can significantly correct this bias and therefore have therapeutic effects to some extent.",2020,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","['young adults with internet gaming disorder', 'individuals with Internet gaming disorder', '48 individuals with Internet gaming disorder']","['4-day stimulus-response compatibility (SRC) approach bias modification treatment', 'corresponding SRC pseudomodification training', 'Behavioral modification']","['scores for Internet gaming disorder severity, anxiety level and craving', 'response time', 'gaming cues']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",48.0,0.0253849,"After the modification, the response time of the experimental group to the gaming cues significantly increased, whereas the scores for Internet gaming disorder severity, anxiety level and craving significantly decreased.","[{'ForeName': 'Jinbo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China. Electronic address: hjb@mail.ccnu.edu.cn.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Adolescent Cyberpsychology and Behavior of Ministry of Education, Key Laboratory of Human Development and Mental Health of Hubei Province, School of Psychology, Central China Normal University, Wuhan, China.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106686']
1339,33065552,Effect of ticagrelor versus clopidogrel on platelet reactivity measured by thrombelastography in patients with minor stroke or TIA.,"In this study, we tested the effect of ticagrelor versus clopidogrel on platelet reactivity in patients with minor stroke or transient ischemic attack (TIA). A pre-specified subgroup analysis of a randomized controlled trial was conducted. Platelet reactivity was assessed by thrombelastography (TEG) platelet mapping. Patients were divided into carriers and non-carriers according to the carrier status of  CYP2C19  loss-of-function (LOF) alleles. The primary outcome was the proportion of patients with high on-treatment platelet reactivity (HOPR) (defined as maximum amplitude induced by adenosine diphosphate > 47mm) at 90±7 days. Clinical outcomes within 90±7 days were followed up. Among 339 patients, 170 were randomized to ticagrelor/aspirin and 169 to clopidogrel/aspirin. Compared with clopidogrel/aspirin, the proportion of HOPR at 90±7 days in ticagrelor/aspirin was significantly lower (12.2% versus 30.0%,  P  < 0.001). Ticagrelor/aspirin had a lower proportion of HOPR among carriers (11.0% versus 35.6%,  P  < 0.001), but not among non-carriers (13.5% versus 22.4%,  P  = 0.17). Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the  CYP2C19  LOF alleles. Large randomised controlled trials are needed to confirm our findings.",2020,"Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the  CYP2C19  LOF alleles.","['patients with minor stroke or TIA', 'patients with minor stroke or transient ischemic attack (TIA', 'Patients were divided into carriers and non-carriers according to the carrier status of  CYP2C19  loss-of-function (LOF) alleles', '339 patients, 170 were randomized to']","['Ticagrelor', 'clopidogrel/aspirin', 'Ticagrelor/aspirin', 'ticagrelor/aspirin', 'clopidogrel', 'ticagrelor versus clopidogrel', 'ticagrelor']","['HOPR', 'proportion of patients with high on-treatment platelet reactivity (HOPR', 'Platelet reactivity', 'proportion of HOPR', 'platelet reactivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0449439', 'cui_str': 'Carrier status'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",339.0,0.0541763,"Ticagrelor was superior to clopidogrel in inhibiting platelet reactivity measured by TEG platelet mapping among patients with acute minor stroke or TIA, particularly in carriers of the  CYP2C19  LOF alleles.","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]",Aging,['10.18632/aging.103452']
1340,33068631,"Recovery of reward function in problematic substance users using a combination of robotics, electrophysiology, and TMS.","BACKGROUND


Theoretical and empirical work suggest that addictive drugs potentiate dopaminergic reinforcement learning signals and disrupt the reward function of its neural targets, including the anterior midcingulate cortex (aMCC) and the basal ganglia. Here, we aim to use prefrontal 10-Hz TMS to enhance aMCC reward activity and reward learning by the basal ganglia in problematic substance users.
METHODS


22 problematic substance users were randomized into an Active and SHAM (coil flipped) TMS group. We recorded the reward positivity-an electrophysiological signal believed to index sensitivity of the aMCC to rewards-while participants engaged in 4 blocks (100 trials per block) of a reward-based choice task. A robotic arm positioned a TMS coil over a prefrontal cortex target, and 50 pulses were delivered at 10-Hz before every 10 trials of blocks 2-4 (1500 pulses, 400 trials). Participants then completed a decision-making task that is diagnostic of striatal dopamine dysfunction.
RESULTS


The present study revealed three main findings. First, both groups failed to elicit a reward positivity during the first two task blocks. Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks. Third, the Active group performed relatively better at reward-based learning than the SHAM group.
CONCLUSION


These results demonstrate that 10-Hz TMS is successful in modulating the reward function of the aMCC and basal ganglia in problematic substance users, which may have utility in the treatment of reward-related neural dysfunction commonly associated with substance use disorders.",2020,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","['22 problematic substance users', 'problematic substance users']","['10-Hz', 'TMS', 'robotics, electrophysiology, and TMS', 'Active and SHAM (coil flipped', 'robot-assisted TMS', 'prefrontal 10-Hz TMS']",['amplitude of the reward positivity'],"[{'cui': 'C0338666', 'cui_str': 'Misuses drugs'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}]",,0.128632,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Biernacki', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Mei-Heng', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Travis E', 'Initials': 'TE', 'LastName': 'Baker', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America. Electronic address: travis.e.baker@rutgers.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.08.008']
1341,33068667,"Mindfulness, mood, and food: The mediating role of positive affect.","With rates of overweight and obesity rising worldwide, it is important to examine psychological factors associated with food intake. Previous research has shown that mindfulness may serve as a protective factor against overconsumption of food. Some studies have posited that mindfulness addresses unhealthy eating by promoting the increased awareness of, and decreased responsiveness to, internal emotional cues. The present study investigated the effects of a brief mindfulness induction on positive and negative affect and subsequent energy intake in a sample of undergraduate students (N = 126). After exposure to a negative mood induction, 63 participants were randomly assigned to a brief mindfulness intervention, while the remaining participants listened to a news article. Subsequently all participants were offered healthful and unhealthful snack foods. Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake. Relative to controls, those in the experimental condition reported higher positive affect after the mindfulness induction, which in turn reduced their energy intake. Further exploratory analyses indicated that positive affect in the experimental group was associated with reduced consumption of unhealthful food. These findings provide insight into how mindfulness-based interventions may target unhealthy eating behaviors.",2020,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","['63 participants', 'a sample of undergraduate students (N = 126']","['brief mindfulness intervention, while the remaining participants listened to a news article']","['positive and negative affect and subsequent energy intake', 'Mindfulness, Mood, and Food']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0282425', 'cui_str': 'News'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",63.0,0.0206694,"Although there was not a significant between-group difference in intake, a multiple mediation model indicated that positive affect, but not negative affect, significantly mediated the association between condition and food intake.","[{'ForeName': 'Ti', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, U.S.A. Electronic address: ti-hsu@uiowa.edu.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Forestell', 'Affiliation': 'Department of Psychological Sciences, William & Mary, P.O. Box 8795, Williamsburg, VA, 23187-8795, USA. Electronic address: caforestell@wm.edu.'}]",Appetite,['10.1016/j.appet.2020.105001']
1342,33074110,Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked-down due to COVID-19 online randomized study.,"AIM


to compare anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE). Methods- Participants were assessed for BHT and RPE, before training on any one intervention using online platforms, for one week during lockdown from COVID-19.15 participants in each group total N = 60 at- (α - 0.05), (1- β - 0.90) & (effect size - 0.55); were analysed. Results - AVP & DBE decreased RPE (p < 0.000). KBP & PLB did not decrease RPE as compared to AVP & DBE (p. > 0.05). DBE increased BHT more than KBP & PLB interventions (p < 0.05), but not more than AVP (p > 0.05). One-way ANOVA of four interventions revealed significant variation for RPE change (p < 0.05), for AVP. Conclusions - AVP reduces RPE maximally during breath-holding, whereas DPE increases BHT more.",2020,KBP & PLB did not decrease RPE as compared to AVP & DBE,['60\xa0at'],"['Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked', 'AVP & DBE']","['RPE', 'anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE', 'RPE change', 'DBE increased BHT']",[],"[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0686435,KBP & PLB did not decrease RPE as compared to AVP & DBE,"[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': 'AP-III, AIPT, 9711113097, India. Electronic address: mailmayankshukla@gmail.com.'}, {'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Chauhan', 'Affiliation': 'BPT Interns, AIPT, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'BPT Interns, AIPT, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101248']
1343,33074143,Ketamine Alters Electrophysiological Responses to Emotional Faces in Major Depressive Disorder.,"BACKGROUND


The glutamatergic modulator ketamine rapidly reduces depressive symptoms in individuals with treatment-resistant major depressive disorder (MDD). However, ketamine's effects on emotional processing biases remain largely unknown, and understanding these processes may help elucidate ketamine's mechanism of action.
METHODS


Magnetoencephalography (MEG) was used to investigate ketamine's effects on early visual responses to affective stimuli in individuals with MDD (n=31) and healthy volunteers (HVs; n=24). Participants were enrolled in a double-blind, placebo-controlled, crossover clinical trial and were assessed at baseline and after subanesthetic-dose ketamine and placebo-saline infusions. During MEG recording, participants completed an emotional evaluation task in which they indicated the sex or emotional valence (happy-neutral or sad-angry) of facial stimuli. Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies were extracted from regions of interest. Linear fixed effects models examined interactions between diagnosis, stimulus valence, and drug session for behavioral and MEG data.
RESULTS


In baseline behavioral analyses, MDD participants exhibited higher accuracy for sad-angry than happy-neutral faces, and HVs responded faster to happy-neutral than sad-angry faces. In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine. Finally, fusiform M170 amplitudes were associated with antidepressant response in MDD participants.
LIMITATIONS


The modest sample size and the need to collapse across responses to happy and neutral faces to increase statistical power limit the generalizability of the findings.
CONCLUSIONS


Ketamine rapidly altered emotional stimulus processing in MDD, laying the groundwork for future investigations of biomarkers of antidepressant treatment response.
CLINICAL TRIAL


Clinicaltrials.gov, NCT#00088699.",2020,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","['individuals with MDD (n=31) and healthy volunteers (HVs; n=24', 'Major Depressive Disorder', 'individuals with treatment-resistant major depressive disorder (MDD']","[""ketamine's"", 'Ketamine', 'glutamatergic modulator ketamine', 'ketamine', 'Magnetoencephalography (MEG', 'ketamine and placebo-saline infusions', 'placebo']","['Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies', 'sex or emotional valence (happy-neutral or sad-angry) of facial stimuli', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.464333,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","[{'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Sepe-Forrest', 'Affiliation': 'Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Carver', 'Affiliation': 'Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Janssen Pharmaceuticals of Johnson and Johnson Inc., San Diego, CA, United States.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA;. Electronic address: nugenta@mail.nih.gov.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.007']
1344,33074208,Performance pay and low-grade stress: An experimental study.,"BACKGROUND


Although recent economics literature suggests a link between performance-related pay (PRP) and ill health, this finding is contested on the grounds that this link is plagued by endogeneity between the two variables of interest.
OBJECTIVE


This study investigates the adverse effects of performance-related pay on stress which is an important determinant of physical health.
METHODS


Forty subjects were randomly assigned to two equal groups: either being paid by performance or being paid a flat fee. Both objective (saliva samples to measure cortisol elevation) and subjective (self-reported stress level) measures of stress were obtained before and after participation in the experiment. This experimental methodology purges the effects of self-selection into performance pay and identifies the direction of causation from performance-related pay to stress which is measured by cortisol levels.
RESULTS


Those who were paid for their performance experienced higher levels of stress, both in terms of perceived stress and in terms of objectively measured cortisol levels, compared to those who were paid a flat fee for minimum performance.
CONCLUSIONS


Performance-related pay induces objectively measurable stress. Self-reported stress levels and the objective stress measure obtained by measuring cortisol move in a similar direction for the PRP and non-PRP groups, but only the cortisol group shows statistically significant differences between the PRP and non-PRP. This also suggests that individuals underestimate the stress caused by performance pay.",2020,"Those who were paid for their performance experienced higher levels of stress, both in terms of perceived stress and in terms of objectively measured cortisol levels, compared to those who were paid a flat fee for minimum performance.
",['Forty subjects'],['being paid by performance or being paid a flat fee'],"['cortisol elevation) and subjective (self-reported stress level) measures of stress', 'Performance pay and low-grade stress']",[],"[{'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0015751', 'cui_str': 'Fees'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}]",40.0,0.017219,"Those who were paid for their performance experienced higher levels of stress, both in terms of perceived stress and in terms of objectively measured cortisol levels, compared to those who were paid a flat fee for minimum performance.
","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Allan', 'Affiliation': 'Institute for Applied Health Sciences and Aberdeen Health Psychology Group, Health Sciences Building, Foresterhill, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Bender', 'Affiliation': 'Department of Economics and Centre for European Labour Market Research, Edward Wright Building, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Theodossiou', 'Affiliation': 'Department of Economics and Centre for European Labour Market Research, Edward Wright Building, University of Aberdeen, Aberdeen, UK.'}]","Work (Reading, Mass.)",['10.3233/WOR-203294']
1345,33068425,Hydroxychloroquine as pre-exposure prophylaxis for COVID-19 in healthcare workers: a randomized trial.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a rapidly emerging virus causing the ongoing Covid-19 pandemic with no known effective prophylaxis. We investigated whether hydroxychloroquine could prevent SARS-CoV-2 in healthcare workers at high risk of exposure.
METHODS


We conducted a randomized, double-blind, placebo-controlled clinical trial of healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders. Participants across the United States and in the Canadian province of Manitoba were randomized to hydroxychloroquine 400mg once weekly or twice weekly for 12 weeks. The primary endpoint was confirmed or probable Covid-19-compatible illness. We measured hydroxychloroquine whole blood concentrations.
RESULTS


We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures. The incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness) was 0.27 events per person-year with once-weekly and 0.28 events per person-year with twice-weekly hydroxychloroquine compared with 0.38 events per person-year with placebo. For once weekly hydroxychloroquine prophylaxis, the hazard ratio was 0.72 (95%CI 0.44 to 1.16; P=0.18), and for twice-weekly was 0.74 (95%CI 0.46 to 1.19; P=0.22) as compared with placebo. Median hydroxychloroquine concentrations in whole blood were 98 ng/mL (IQR, 82-120) with once-weekly and 200 ng/mL (IQR, 159-258) with twice-weekly dosing. Hydroxychloroquine concentrations did not differ between participants who developed Covid-19-compatible illness (154 ng/mL) versus participants without Covid-19 (133 ng/mL; P=0.08).
CONCLUSIONS


Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.",2020,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"['healthcare workers', 'healthcare workers at high risk of exposure', 'Participants across the United States and in the Canadian province of Manitoba', 'We enrolled 1483 healthcare workers, of which 79% reported performing aerosol-generating procedures', 'healthcare workers with ongoing exposure to persons with SARS-CoV-2, including those working in emergency departments, intensive care units, Covid-19 hospital wards, and first responders']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['Covid-19-compatible illness', 'probable Covid-19-compatible illness', 'Hydroxychloroquine concentrations', 'Median hydroxychloroquine concentrations', 'incidence of Covid-19 (laboratory-confirmed or symptomatic compatible illness']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",1483.0,0.743112,Pre-exposure prophylaxis with hydroxychloroquine once or twice weekly did not significantly reduce laboratory-confirmed Covid-19 or Covid-19-compatible illness among healthcare workers.,"[{'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Balko', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Dunlop', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katherine H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1571']
1346,33069606,A consumer co-created infographic improves short-term knowledge about physical activity and self-efficacy to exercise in women with gestational diabetes mellitus: a randomised trial.,"QUESTION


In women with gestational diabetes mellitus, does the addition of a consumer co-created infographic to usual education about gestational diabetes mellitus improve knowledge about physical activity and self-efficacy to exercise?
DESIGN


A randomised trial with concealed allocation, a blinded assessor and intention-to-treat analysis.
PARTICIPANTS


Sixty-nine women diagnosed with gestational diabetes mellitus.
INTERVENTION


In addition to gestational diabetes education, the experimental group received a paper copy of a consumer co-created infographic about physical activity during a gestational diabetes pregnancy. The control group received gestational diabetes education alone.
OUTCOME MEASURES


Participants completed outcome measures at baseline and again 1 week later. Knowledge of physical activity in a gestational diabetes mellitus pregnancy was assessed using a 19-item questionnaire modified to reflect current physical activity guidelines, with a total score from 0% (worst) to 100% (best). Self-efficacy was measured using the nine-item Self-Efficacy for Exercise Scale, with a total score from 0 (not confident) to 10 (very confident).
RESULTS


Provision of the infographic led to a clinically important between-group difference in knowledge (MD 12%, 95% CI 10 to 15) and self-efficacy (MD 2.5 units, 95% CI 1.9 to 3.0).
CONCLUSION


In women with gestational diabetes mellitus, short-term knowledge about physical activity and self-efficacy to exercise were improved when usual education was supplemented with a consumer co-created infographic that provided specific and relevant information about physical activity during a gestational diabetes mellitus pregnancy.
TRIAL REGISTRATION


ACTRN12619001207101.",2020,"In women with gestational diabetes mellitus, short-term knowledge about physical activity and self-efficacy to exercise were improved when usual education was supplemented with a consumer co-created infographic that provided specific and relevant information about physical activity during a gestational diabetes mellitus pregnancy.
","['women with gestational diabetes mellitus', 'Sixty-nine women diagnosed with gestational diabetes mellitus']","['gestational diabetes education alone', 'paper copy of a consumer co-created infographic about physical activity']","['Self-efficacy', 'self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",69.0,0.135428,"In women with gestational diabetes mellitus, short-term knowledge about physical activity and self-efficacy to exercise were improved when usual education was supplemented with a consumer co-created infographic that provided specific and relevant information about physical activity during a gestational diabetes mellitus pregnancy.
","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Harrison', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Australia; Physiotherapy Department, Werribee Mercy Hospital, Melbourne, Australia. Electronic address: AHarrison@mercy.com.au.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Australia; Allied Health Clinical Research Office, Eastern Health, Melbourne, Australia.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Frawley', 'Affiliation': 'School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Shields', 'Affiliation': 'Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Australia.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.09.010']
1347,33069608,"Feedback-guided exercises performed on a tablet touchscreen improve return to work, function, strength and healthcare usage more than an exercise program prescribed on paper for people with wrist, hand or finger injuries: a randomised trial.","QUESTION


In people with bone and soft tissue injuries of the wrist, hand and/or fingers, do feedback-guided exercises performed on a tablet touchscreen hasten return to work, reduce healthcare usage and improve clinical recovery more than a home exercise program prescribed on paper?
DESIGN


Randomised, parallel-group trial with concealed allocation, assessor blinding and intention-to-treat analysis.
PARTICIPANTS


Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers.
INTERVENTION


Participants in the experimental and control groups received the same in-patient physiotherapy and occupational therapy. Participants in the experimental group received a home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression. Participants in the control group were prescribed an evidence-based home exercise program on paper.
OUTCOME MEASURES


The primary outcome was the time taken to return to work. Secondary outcomes included: healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation.
RESULTS


Compared with the control group, the experimental group: returned to work sooner (MD -18 days, 95% CI -33 to -3); required fewer physiotherapy sessions (MD -7.4, 95% CI -13.1 to -1.6), rehabilitation consultations (MD -1.9, 95% CI -3.6 to 0.3) and plastic surgery consultations (MD -3.6, 95% CI -6.3 to -0.9); and had better short-term recovery of functional ability and pinch strength.
CONCLUSION


In people with bone and soft-tissue injuries of the wrist, hand and/or fingers, prescribing a feedback-guided home exercise program using a tablet-based application instead of a conventional program on paper hastened return to work and improved the short-term recovery of functional ability and pinch strength, while reducing the number of required healthcare appointments.
TRIAL REGISTRATION


ACTRN12619000344190.",2020,"Compared with the control group, the experimental group: returned to work sooner (MD -18 days, 95% CI -33 to -3); required fewer physiotherapy sessions (MD -7.4, 95% CI -13.1 to -1.6), rehabilitation consultations (MD -1.9, 95% CI -3.6 to 0.3) and plastic surgery consultations (MD -3.6, 95% CI -6.3 to -0.9); and had better short-term recovery of functional ability and pinch strength.
","['people with wrist, hand or finger injuries', 'Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers']","['home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression', 'Feedback-guided exercises', 'same in-patient physiotherapy and occupational therapy', 'evidence-based home exercise program on paper', 'exercise program']","['rehabilitation consultations', 'healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation', 'plastic surgery consultations', 'functional ability and pinch strength', 'time taken to return to work']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016124', 'cui_str': 'Injury of finger'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}]",74.0,0.0831718,"Compared with the control group, the experimental group: returned to work sooner (MD -18 days, 95% CI -33 to -3); required fewer physiotherapy sessions (MD -7.4, 95% CI -13.1 to -1.6), rehabilitation consultations (MD -1.9, 95% CI -3.6 to 0.3) and plastic surgery consultations (MD -3.6, 95% CI -6.3 to -0.9); and had better short-term recovery of functional ability and pinch strength.
","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Blanquero', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain.'}, {'ForeName': 'María-Dolores', 'Initials': 'MD', 'LastName': 'Cortés-Vega', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain. Electronic address: mdcortes@us.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Sánchez-Laulhé', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain.'}, {'ForeName': 'Berta-Pilar', 'Initials': 'BP', 'LastName': 'Corrales-Serra', 'Affiliation': 'Physiotherapy Department, Ibermutua, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gómez-Patricio', 'Affiliation': 'Occupational Therapy Department, Ibermutua, Spain.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Díaz-Matas', 'Affiliation': 'Physiotherapy Department, Ibermutua, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Suero-Pineda', 'Affiliation': 'Physiotherapy Department, University of Seville, Seville, Spain.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.09.012']
1348,33073933,Evaluation of Improvement in Skin and Nail Psoriasis in Bio-naïve Patients With Active Psoriatic Arthritis Treated With Golimumab: Results Through Week 52 of the GO-VIBRANT Study.,"OBJECTIVE


To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis.
METHODS


Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria.
RESULTS


Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo. Responses were maintained in patients treated with golimumab through week 52. In placebo-crossover patients, increases in the proportion of patients achieving PASI 75/90/100 responses were observed from weeks 24 to 52, and mean improvements in mNAPSI (from -3.7 to -12.9) and DLQI (from -2.9 to -7.8) increased from weeks 24 to 52. Simultaneous achievement of PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses were also observed. Similar responses were observed for all assessments regardless of concomitant methotrexate use.
CONCLUSION


Improvements in skin and nail psoriasis symptoms with IV golimumab in patients with psoriatic arthritis were concomitant with improvements in QoL and arthritis disease activity through 1 year.",2020,"Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo.","['Patients', 'patients with psoriatic arthritis']","['Golimumab', 'placebo', 'IV golimumab', 'intravenous (IV) golimumab']","['mean improvements in mNAPSI', 'mNAPSI', 'proportion of patients achieving PASI 75/90/100 responses', 'QoL and arthritis disease activity', 'Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria', 'Skin and Nail Psoriasis', 'quality of life (QoL) and joint symptoms', 'PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses', 'DLQI', 'skin and nail symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]",,0.081377,"Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center, Seattle, Washington and University of Washington School of Medicine, Seattle.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elaine Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Soumya D', 'Initials': 'SD', 'LastName': 'Chakravarty', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania, and, Drexel University College of Medicine, Philadelphia, PA.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Kafka', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Parenti', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hung Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California, San Diego.'}]",ACR open rheumatology,['10.1002/acr2.11180']
1349,33078673,Validation of Colorectal Cancer Models on Long-term Outcomes from a Randomized Controlled Trial.,"Microsimulation models are often used to predict long-term outcomes and guide policy decisions regarding cancer screening. The United Kingdom Flexible Sigmoidoscopy Screening (UKFSS) Trial examines a one-time intervention of flexible sigmoidoscopy that was implemented before a colorectal cancer (CRC) screening program was established. Long-term study outcomes, now a full 17 y following randomization, have been published. We use the outcomes from this trial to validate 3 microsimulation models for CRC to long-term study outcomes. We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening. We find that all 3 models yield predictions of the relative effect of screening on CRC incidence and mortality (i.e., the hazard ratios) that are reasonably close to the UKFSS results. Two of the 3 models accurately predict the relative reduction in CRC incidence 17 y after screening. One model accurately predicted the absolute incidence and mortality rates in the screened group. The models differ in their estimates related to adenoma detection at screening. Although high-quality screening results help to inform models, trials are expensive, last many years, and can be complicated by ethical issues and technological changes across the duration of the trial. Thus, well-calibrated and validated models are necessary to predict outcomes for which data are not available. The results from this validation demonstrate the utility of models in predicting long-term outcomes and in collaborative modeling to account for uncertainty.",2020,We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening.,[],"['flexible sigmoidoscopy', 'United Kingdom Flexible Sigmoidoscopy Screening (UKFSS']","['absolute incidence and mortality rates', 'CRC incidence and mortality']",[],"[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.0305501,We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DeYoreo', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lansdorp-Vogelaar', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Zuid-Holland, the Netherlands.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Knudsen', 'Affiliation': 'Institute for Technology Assessment and Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kuntz', 'Affiliation': 'Department of Health Policy and Management, University of Minnesota, School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, NY, USA.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Rutter', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20961095']
1350,33073594,Testing the Effects of Hookah Tobacco Social Media Risk Communication Messages Among Young Adults.,"BACKGROUND


Hookah tobacco is commonly used among young adults, and use is driven in part by widespread misperceptions about risks. Social media use, particularly Instagram, is prominent in this population and exposure to commercial and user-generated content promoting hookah commonly occurs.
AIMS


This study tested the effects of hookah tobacco risk messaging for delivery via Instagram as a strategy to offset exposure to content promoting hookah use among young adults.
METHOD


Young adult hookah smokers were recruited online for a 2 × 3 between-subjects experiment ( n  = 601). Participants completed preexposure measures and were randomized to view hookah tobacco Instagram ads (commercial or user generated) with risk messages (none, risk education, or graphic risk). Stimuli were presented as a simulated Instagram feed. After viewing the stimuli, participants completed postexposure outcome measures.
RESULTS


There was a statistically significant main effect of risk message type but no significant main effect of Instagram ad type or risk message type by ad type interactions. Exposure to the graphic risk and risk education messages were associated with lower intentions to engage with hookah tobacco ads on Instagram. Graphic risk and risk education messages produced greater negative emotional response and the graphic messages increased motivation to quit compared with Instagram ads alone.
DISCUSSION


Findings provide preliminary evidence that hookah tobacco risk messages delivered via Instagram can offset the influence of content promoting the use of hookah tobacco.
CONCLUSION


This study represents an example of risk message testing and the results suggest the messages warrant further testing via social media delivery.",2020,"Graphic risk and risk education messages produced greater negative emotional response and the graphic messages increased motivation to quit compared with Instagram ads alone.
","['Young Adults', 'young adults', 'Young adult hookah smokers were recruited online for a 2 × 3 between-subjects experiment ( n  = 601']","['hookah tobacco risk messaging', 'view hookah tobacco Instagram ads (commercial or user generated) with risk messages (none, risk education, or graphic risk', 'Hookah Tobacco Social Media Risk Communication Messages']","['negative emotional response', 'motivation to quit']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4302493', 'cui_str': 'Hookah pipe'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C4505132', 'cui_str': 'Hookah Tobacco'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0402818,"Graphic risk and risk education messages produced greater negative emotional response and the graphic messages increased motivation to quit compared with Instagram ads alone.
","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198120963104']
1351,33071206,Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial.,"INTRODUCTION


The COVID-19 pandemic has presented challenges to managing vascular risk factors with in-person follow-up of patients with asymptomatic carotid stenosis enrolled in the CREST2 trial. CREST2 is comparing intensive medical management alone versus intensive medical management plus revascularization with endarterectomy or stenting. We performed a study to evaluate the feasibility of a home-based program for testing blood pressure (BP) and low-density lipoprotein (LDL) in CREST2.
METHODS


This study involved 45 patients at 10 sites in the CREST2 trial. The initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL > 90 mg/dl, or both. If a patient at the site declined participation, another was substituted. All patients who agreed to participate were sent a BP monitoring device and a commercially available at-home lipid test kit that uses a self-performed finger-stick blood sample that was resulted to the patient. Training on the use of the equipment and obtaining the risk factor results was done by the study coordinator by telephone.
RESULTS


Ten of the 130 currently active CREST2 sites participated, 8 in the LDL portion and 5 in the BP portion (3 sites did both). Twenty-six BP devices and 23 lipid tests were sent to patients. Of the 26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3. Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
CONCLUSION


This study established the feasibility of at-home monitoring of BP and LDL in a clinical trial and identified implementation challenges prior to widespread use in the trial. (ClinicalTrials.gov number NCT02089217).",2020,"Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
","['23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4', 'participants in a carotid stenosis trial', 'patients with asymptomatic carotid stenosis enrolled in the CREST2 trial', '45 patients at 10 sites in the CREST2 trial', 'initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL ', '26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3']","['COVID-19 pandemic', 'CREST2']",['testing blood pressure (BP) and low-density lipoprotein (LDL'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}]",45.0,0.0283477,"Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Neurology, Medical University of South Carolina (MUSC), 96 Jonathan Lucas Street, MSC 606, Charleston 29425, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Roldan', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'LeMatty', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Sothear', 'Initials': 'S', 'LastName': 'Luke', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Breathitt', 'Affiliation': 'Neurology, Baptist Health Lexington, Lexington, KY, United States.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Eiland', 'Affiliation': 'Cardiovascular Associates, Brookwood Baptist Health, Birmingham, AL, United States.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Foley', 'Affiliation': 'Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105362']
1352,33079070,Health-Related Quality of Life Improvements in Systemic Lupus Erythematosus Derived from a Digital Therapeutic Plus Tele-Health Coaching Intervention: Randomized Controlled Pilot Trial.,"BACKGROUND


Systemic lupus erythematosus (SLE), a systemic autoimmune disease with no known cure, remains poorly understood and patients suffer from many gaps in care. Recent work has suggested that dietary and other lifestyle factors play an important role in triggering and propagating SLE in some susceptible individuals. However, the magnitude of influence of these triggers, how to identify pertinent triggers in individual patients, and whether removing these triggers confers clinical benefit is unknown.
OBJECTIVE


To demonstrate that a digital therapeutic intervention, utilizing a mobile app that allows self-tracking of dietary, environmental, and lifestyle triggers, paired with telehealth coaching, added to usual care, improves quality of life in patients with SLE compared with usual care alone.
METHODS


In this randomized controlled pilot study, adults with SLE were assigned to a 16-week digital therapeutic intervention plus usual care or usual care alone. Primary outcome measures were changes from baseline to 16 weeks on 3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL).
RESULTS


A total of 50 patients were randomized (23 control, 27 intervention). In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.
CONCLUSIONS


A digital therapeutic intervention that pairs self-tracking with telehealth coaching to identify and remove dietary, environmental, and lifestyle symptom triggers resulted in statistically significant, clinically meaningful improvements in HRQoL when added to usual care in patients with SLE.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03426384; https://clinicaltrials.gov/ct2/show/NCT03426384.",2020,"In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.
","['patients with SLE compared with usual care alone', 'adults with SLE', 'Systemic Lupus Erythematosus', '50 patients', 'patients with SLE']","['digital therapeutic intervention plus usual care or usual care alone', 'Digital Therapeutic Plus Tele-Health Coaching Intervention']","['LupusQoL-Fatigue', 'multiple comparisons; BPI-SF-Pain Severity', 'LupusQoL-Emotional Health', 'LupusQoL-Pain', 'LupusQoL-Planning', 'LupusQoL-Physical Health', '3 validated health-related quality of life (HRQoL) tools: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Pain Inventory-Short Form (BPI-SF), and Lupus Quality of Life (LupusQoL', 'quality of life', 'BPI-SF-Pain Interference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0024131', 'cui_str': 'Lupus vulgaris'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",50.0,0.175888,"In per-protocol analysis, the intervention group achieved significantly greater improvement than the control group in 9 of 11 domains: FACIT-F (34% absolute improvement for the intervention group vs -1% for the control group, P<.001), BPI-SF-Pain Interference (25% vs 0%, P=.02), LupusQoL-Planning (17% vs 0%, P=.004), LupusQoL-Pain (13% vs 0%, P=.004), LupusQoL-Emotional Health (21% vs 4%, P=.02), and LupusQoL-Fatigue (38% vs 13%, P<.001) were significant when controlling for multiple comparisons; BPI-SF-Pain Severity (13% vs -6%, P=.049), LupusQoL-Physical Health (17% vs 3%, P=.049), and LupusQoL-Burden to Others (33% vs 4%, P=.04) were significant at an unadjusted 5% significance level.
","[{'ForeName': 'Faiz', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'EVP, CityMD, Dix Hills, NY, United States.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Granville', 'Affiliation': 'Independent Researcher, New York, NY, United States.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Malkani', 'Affiliation': 'Independent Researcher, Austin, TX, United States.'}, {'ForeName': 'Yash', 'Initials': 'Y', 'LastName': 'Chathampally', 'Affiliation': 'Harris Health, Houston, TX, United States.'}]",Journal of medical Internet research,['10.2196/23868']
1353,33079071,Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial.,"BACKGROUND


Loneliness is a widespread and significant problem on college campuses. Prolonged loneliness in young adulthood is a risk factor for concurrent and future mental health problems and attrition, making college a critical time for support. Cognitive and behavioral interventions show promise for decreasing loneliness and can be widely disseminated through technology.
OBJECTIVE


This pilot randomized controlled trial was conducted to examine the initial efficacy, feasibility, and desirability of a smartphone app, Nod, designed to deliver cognitive and behavioral skill-building exercises to reduce loneliness during the transition to college.
METHODS


First-year college students (N=221, mean age 18.7 years, 59% female) were recruited online during incoming student orientation, and randomized to either receive immediate access to Nod (experimental group, n=100) or access after 4 weeks (control group, n=121). The app delivered skills via fully automated (1) ""social challenges,"" suggested activities designed to build social connections; (2) reflections, brief cognitive reframing exercises; and (3) student testimonials that encouraged a growth mindset toward social connection building. Main intention-to-treat analyses were used to compare the conditions on self-assessed loneliness, depressive symptoms, and other mental health and college adjustment outcomes at week 4, controlling for baseline values on those variables. Analyses were also performed to test the hypothesis that the treatment benefits would be particularly pronounced for participants with heightened psychological vulnerability at baseline (ie, higher baseline depressive symptoms and loneliness).
RESULTS


Retention was 97% at week 4, and participants viewed an average 36.7 pages of app content. There were no significant condition differences in loneliness at week 4 (F 1, 211 =0.05, P=.82; η p 2  <.001). However, there was a significant condition-by-baseline depression interaction to predict week-4 loneliness (F 1,209 =9.65, P=.002; η p 2  =.04). Simple slope analyses indicated that baseline depression positively predicted week-4 loneliness among control participants (r=0.30, t 209 =3.81, P<.001), but not among experimental participants (r=-0.09, t 209 =-0.84, P=.40), suggesting that Nod buffered participants with high baseline depression scores from experiencing heightened midquarter loneliness. Similarly, there were no significant condition differences in other week-4 outcomes. However, moderation by baseline vulnerability was found for week-4 depressive symptoms, sleep quality, and indices of college adjustment (eg, perceived social support and campus belonging).
CONCLUSIONS


Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students. The results of this trial suggest that cognitive and behavioral skills delivered via a mobile app can buffer psychologically vulnerable college students against heightened loneliness and depressive symptoms, as well as other negative college adjustment outcomes. Future work will aim to improve upon app engagement, and to address loneliness among other key populations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04164654; https://clinicaltrials.gov/ct2/show/NCT04164654.",2020,"Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students.","['College Students', 'First-year college students (N=221, mean age 18.7 years, 59% female']","['smartphone app, Nod, designed to deliver cognitive and behavioral skill-building exercises', 'skills via fully automated (1) ""social challenges,"" suggested activities designed to build social connections; (2) reflections, brief cognitive reframing exercises; and (3) student testimonials that encouraged a growth mindset toward social connection building']","['Prolonged loneliness', 'self-assessed loneliness, depressive symptoms, and other mental health and college adjustment outcomes', 'week-4 depressive symptoms, sleep quality, and indices of college adjustment (eg, perceived social support and campus belonging', 'loneliness']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0085243', 'cui_str': 'Mouse, Inbred NOD'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",,0.176522,"Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Bruehlman-Senecal', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Cayce J', 'Initials': 'CJ', 'LastName': 'Hook', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'FitzGerald', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR, United States.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Haritatos', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Hopelab, San Francisco, CA, United States.'}]",JMIR mental health,['10.2196/21496']
1354,33069121,Add-on memantine may improve cognitive functions and attenuate inflammation in middle- to old-aged bipolar II disorder patients.,"OBJECTIVES


Chronic inflammation and neuroprogression underlie bipolar disorder (BP) and associated cognitive deficits. Memantine (MM) exerts neuroprotective effects by reducing neuroinflammation. Therefore, we investigated whether add-on low-dose MM (5 mg/day) in BP-II patients may improve cognition and inflammation.
METHODS


We combined two 12-week randomized, double-blind, placebo-controlled studies (NCT01188148 and NCT03039842) for analysis. Each participant was allocated to the MM or placebo group. Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1 (TGF-β1), and brain-derived neurotrophic factor (BDNF)] were evaluated at baseline and endpoint. A subgroup analysis of middle- to old-aged BP-II patients was also performed.
RESULTS


We recruited 155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group. Add-on MM did not result in significant improvements in cognitive functions in all BP-II patients, but a group difference in TNF-α levels was found in the MM group (P=0.04). Specifically, in middle- to old-aged BP-II patients, there was a significant time and group interaction effect on omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs) in the MM group (P=0.007, 0.02, and 0.01, respectively), and a decrease in plasma TNF-α levels (P=0.04).
LIMITATIONS


The sample size of middle- to old-aged BP-II patients were limited.
CONCLUSION


Add-on MM may attenuate inflammation in BP-II and improve cognition in middle- to old-aged BP-II patients.",2020,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","['155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group', 'sample size of middle- to old-aged BP-II patients were limited', 'middle- to old-aged bipolar II disorder patients']","['MM or placebo', 'placebo', 'Memantine (MM', 'memantine']","['TGF-β1), and brain-derived neurotrophic factor (BDNF', 'omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs', 'TNF-α levels', 'cognition and inflammation', 'cognitive functions', 'plasma TNF-α levels', 'Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.407349,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","[{'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Yanjiao Furen Hospital, Hebei, China.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: wangty@mail.ncku.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Hsuan', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Asia University, Taichung, Taiwan; Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Student Counseling Center, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'I Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Neurobiology Laboratory, NIH/NIEHS, Research Triangle Park, NC, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.003']
1355,33069883,OCT Signal Enhancement with Deep Learning.,"PURPOSE


To establish whether deep learning methods are able to improve the signal-to-noise ratio of time-domain (TD) OCT images to approach that of spectral-domain (SD) OCT images.
DESIGN


Method agreement study and progression detection in a randomized, double-masked, placebo-controlled, multicenter trial for open-angle glaucoma (OAG), the United Kingdom Glaucoma Treatment Study (UKGTS).
PARTICIPANTS


The training and validation cohort comprised 77 stable OAG participants with TD OCT and SD OCT imaging at up to 11 visits within 3 months. The testing cohort comprised 284 newly diagnosed OAG patients with TD OCT images from a cohort of 516 recruited at 10 United Kingdom centers between 2007 and 2010.
METHODS


An ensemble of generative adversarial networks (GANs) was trained on TD OCT and SD OCT image pairs from the training dataset and applied to TD OCT images from the testing dataset. Time-domain OCT images were converted to synthesized SD OCT images and segmented via Bayesian fusion on the output of the GANs.
MAIN OUTCOME MEASURES


Bland-Altman analysis assessed agreement between TD OCT and synthesized SD OCT average retinal nerve fiber layer thickness (RNFLT) measurements and the SD OCT RNFLT. Analysis of the distribution of the rates of RNFLT change in TD OCT and synthesized SD OCT in the two treatment arms of the UKGTS was compared. A Cox model for predictors of time-to-incident visual field (VF) progression was computed with the TD OCT and the synthesized SD OCT images.
RESULTS


The 95% limits of agreement were between TD OCT and SD OCT were 26.64 to -22.95; between synthesized SD OCT and SD OCT were 8.11 to -6.73; and between SD OCT and SD OCT were 4.16 to -4.04. The mean difference in the rate of RNFLT change between UKGTS treatment and placebo arms with TD OCT was 0.24 (P = 0.11) and with synthesized SD OCT was 0.43 (P = 0.0017). The hazard ratio for RNFLT slope in Cox regression modeling for time to incident VF progression was 1.09 (95% confidence interval [CI], 1.02-1.21; P = 0.035) for TD OCT and 1.24 (95% CI, 1.08-1.39; P = 0.011) for synthesized SD OCT.
CONCLUSIONS


Image enhancement significantly improved the agreement of TD OCT RNFLT measurements with SD OCT RNFLT measurements. The difference, and its significance, in rates of RNFLT change in the UKGTS treatment arms was enhanced and RNFLT change became a stronger predictor of VF progression.",2020,"The difference, and its significance, in rates of RNFLT change in the UKGTS treatment arms was enhanced and RNFLT change became a stronger predictor of VF progression.","['Cohort for training and validation: 77 stable OAG participants with TDOCT and SDOCT imaging at up to 11 visits within 3 months', 'Cohort for testing: 284 newly-diagnosed OAG patients with TDOCT from a cohort of 516 recruited at 10 UK centres between 2007 and 2010']",['placebo'],"['OCT signal enhancement', '1) Bland-Altman analysis to assess agreement between TDOCT and synthesized SDOCT average retinal nerve fibre layer thickness (RNFLT) measurements and the SDOCT RNFLT', 'rates of RNFLT change', 'VF progression', 'hazard ratio for RNFLT slope', 'rate of RNFL change']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.128628,"The difference, and its significance, in rates of RNFLT change in the UKGTS treatment arms was enhanced and RNFLT change became a stronger predictor of VF progression.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Lazaridis', 'Affiliation': ""NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; Centre for Medical Image Computing, University College London, London, United Kingdom; School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom. Electronic address: g.lazaridis@ucl.ac.uk.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lorenzi', 'Affiliation': ""Epione Research Project, Centre Inria Sophia Antipolis - Méditerranée, Université Côte d'Azur, Valbonne, Antibes, France.""}, {'ForeName': 'Jibran', 'Initials': 'J', 'LastName': 'Mohamed-Noriega', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom; Departamento de Oftalmología, Hospital Universitario, UANL, Monterrey, México.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Aguilar-Munoa', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Ourselin', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.10.008']
1356,33069970,Labor neuraxial analgesia and breastfeeding: An updated systematic review.,"INTRODUCTION


There have been numerous reports studying the effect of neuraxial analgesia on breastfeeding success, but the results are inconsistent.
METHODS


We performed a literature search in various databases for studies comparing neuraxial analgesia to non-neuraxial or no analgesia. Outcomes were the percentage of women breastfeeding fully or mixed with formula. Where possible, nulliparous parturients were analyzed separately. We conducted an analysis excluding studies of serious and critical risk of bias. Odds ratios and 95% confidence intervals were calculated.
RESULTS


We included 15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants. Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results). In nulliparous only studies, 2 found no difference between study groups, 1 found a lower breastfeeding rate in the neuraxial group and 3 studies showed mixed results. Excluding studies with a serious and critical risk of bias, 1 study found no difference between study groups, 3 studies found a decrease of breastfeeding rates in the neuraxial group, and 1 study showed mixed results.
DISCUSSION


In our review we found a high disparity in results. One reason is probably the high potential of confounding (immediate skin to skin placement, maternity leave etc.). Education programs and breastfeeding support are likely more important in determining long term breastfeeding success.",2020,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","['nulliparous parturients', '15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants']",['Labor neuraxial analgesia and breastfeeding'],"['breastfeeding rates', 'incidence of breastfeeding', 'breastfeeding rate']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16112.0,0.0676764,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Heesen', 'Affiliation': 'Faculty of Medicine, University of Zurich, Winterthurerstrasse 190, 8057 Zurich, Switzerland. Electronic address: heesenphilip99@gmail.com.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Halpern', 'Affiliation': 'Department of Anesthesia, University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada. Electronic address: stephen.halpern@sunnybrook.ca.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Beilin', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, and Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, New York, NY 10029, USA. Electronic address: yaakov.beilin@mountsinai.org.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Mauri', 'Affiliation': ""School of Midwifery, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Via della Commenda 19, 20122 Milano, Italy; Department of Mother Child and Newborn Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy. Electronic address: paola.mauri@unimi.it.""}, {'ForeName': 'Leonid A', 'Initials': 'LA', 'LastName': 'Eidelman', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: leidelman@clalit.org.il.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': 'Department of Anesthesia, Kantonsspital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: michael.heesen@ksb.ch.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Orbach-Zinger', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: sharonorbach@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110105']
1357,33069972,Efficacy of prothrombin complex concentrate for reversal of major bleeding due to rivaroxaban: A pilot randomized controlled trial.,,2020,,[],"['rivaroxaban', 'prothrombin complex concentrate']",[],[],"[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4048712', 'cui_str': 'factor IX complex'}]",[],,0.158675,,"[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Sadaghi', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishekar', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: amahmoodpoor@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110093']
1358,33075444,Fostering infant food texture acceptance: A pilot intervention promoting food texture introduction between 8 and 15 months.,"Healthy infant feeding practices form the basis of healthy eating behaviour later in life. The effect of providing parents with recommendations on textured food introduction between 8 and 15 months on children's experience with and acceptance of textured foods was studied. Sixty parent/child dyads were randomly assigned to a control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction. After the intervention, parents completed self-report measures about the introduction of 188 food items, including purees, soft/small pieces, hard/large pieces and double textures. Children's acceptance of eight textured foods was assessed in a laboratory setting. Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15). There was no group difference in children acceptance for any of the textured foods offered in the laboratory. Independent of their study group, children's exposure to texture was associated with birth order, self-feeding with fingers, low gagging frequency and seldom use of commercial baby foods. Higher acceptance was associated with higher exposure to food pieces but not to pureed foods (either smooth or rough) and with children's eating behavioural traits (high food enjoyment, high food responsiveness and low food fussiness). This pilot intervention demonstrated that providing information can be effective in promoting the introduction of small and soft food pieces, but the most effective way to influence the introduction of more challenging textures (hard pieces and double texture) is uncertain. Further research should focus on the identification of barriers to complex texture introduction and on how building on this knowledge for a population-based public health intervention.",2020,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"['Healthy infant feeding practices form the basis of healthy eating behaviour later in life', 'Sixty parent/child dyads']","['control group (CG) receiving current French recommendations and an intervention group (IG) receiving a brochure with supplementary advice, tips and monthly counselling on food texture introduction']","['soft/small food pieces', 'children acceptance']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449582', 'cui_str': 'With texture'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0391997,Parents in the IG introduced more soft/small food pieces (P = 0.004) but not more complex textures (P = 0.15).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tournier', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France. Electronic address: carole.tournier@inrae.fr.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bernad', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Madrelle', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Delarue', 'Affiliation': 'UMR SayFood, Université Paris-Saclay, INRAE, AgroParisTech, F-91300, Massy, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cuvelier', 'Affiliation': 'UMR SayFood, Université Paris-Saclay, INRAE, AgroParisTech, F-91300, Massy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nicklaus', 'Affiliation': ""UMR Centre des Sciences du Goût et de L'Alimentation, AgroSup Dijon, CNRS, INRAE, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}]",Appetite,['10.1016/j.appet.2020.104989']
1359,33075592,Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study.,"OBJECTIVE


Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care.
METHOD


Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders.
RESULTS


Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
CONCLUSION


There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.
CLINICAL TRIAL REGISTRATION


HeadPoST is registered at ClinicalTrials.gov (NCT02162017).",2020,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","['Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America', 'Secondary analysis of the Head Positioning in acute Stroke Trial ', '11,093 acute stroke patients at 114 hospitals in 9 countries', 'Of 11,086 patients included in analyses, 59.7% (n\xa0=\xa06620) had an ASU admission']","['HeadPoST', 'head-up versus head-down positioning']",['probability of receiving reperfusion therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.177773,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shenyang First People's Hospital, Shenyang, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital, Melbourne and Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service - Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Brunser', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia; Heart Health Research Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117187']
1360,33075621,Co-ingested vinegar-soaked or preloaded dried apple mitigated acute postprandial glycemia of rice meal in healthy subjects under equicarbohydrate conditions.,"This study investigated 2 possible approaches to dietary control of acute postprandial responses to a rice-based meal under equicarbohydrate conditions: (1) a dried apple (DA) preload and (2) co-ingestion of vinegar-soaked DA. We hypothesized that both approaches would counteract hyperglycemia with no negative effect on satiety, possibly explained by an inhibitory effect on digestive enzyme activity and/or the effect of the sugar component of the DA. Fifteen healthy female subjects consumed (1) rice, (2) co-ingestion of DA and rice (DA + R), (3) DA preload and rice (PDA + R), (4) rice with sugar solution (same sugar profile as in DA) preloaded (PSS + R), or (5) co-ingestion of rice with vinegar-soaked DA (VDA + R) in a randomized crossover trial. Acute postprandial glycemic response tests and subjective satiety tests were conducted for each test meal. Compared with rice reference, the PA + R and PSS + R achieved 31.4% and 36.3% reduction of the incremental area under the curve 0-120 , 24.3% and 27.0% decreases in the average glucose peak, along with 21.6% and 27.0% decreases in glycemic excursion in 240 minutes, whereas the VDA + R resulted 42.4%, 27.0%, and 29.7% reductions in the incremental area under the curve 0-120 , peak, and glycemic excursion, respectively. The DA-containing meals had no effect or a favorable effect on satiety. The in vitro assay found larger resistant starch and smaller rapid digestible starch fractions in DA + R and VDA + R meals compared to those of the rice reference (P < .001). The result of this study supported the research hypothesis, and the DA-containing meals could be considered as a potential dietary approach for glycemic management.",2020,The DA-containing meals had no effect or a favorable effect on satiety.,"['Fifteen healthy female subjects consumed (1) rice, (2', 'healthy subjects under equicarbohydrate conditions']","['co-ingestion of DA and rice (DA\u202f+\u202fR), (3) DA preload and rice (PDA\u202f+\u202fR), (4) rice with sugar solution (same sugar profile as in DA) preloaded (PSS\u202f+\u202fR), or (5) co-ingestion of rice with vinegar-soaked DA (VDA\u202f+\u202fR', 'rice-based meal under equicarbohydrate conditions: (1) a dried apple (DA) preload and (2) co-ingestion of vinegar-soaked DA', 'Co-ingested vinegar-soaked or preloaded dried apple']","['satiety', 'larger resistant starch and smaller rapid digestible starch fractions', 'Acute postprandial glycemic response tests and subjective satiety tests', 'average glucose peak', 'glycemic excursion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0453298', 'cui_str': 'Dried apple'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0148405', 'cui_str': 'Vinegar'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",15.0,0.0183585,The DA-containing meals had no effect or a favorable effect on satiety.,"[{'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: zhaowenqi@cau.edu.cn.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: lynn9523@126.com.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China; Key Laboratory of Precision Nutrition and Food Quality, Department of Nutrition and Health, China Agricultural University, Beijing 100083. Electronic address: daisyfan@cau.edu.cn.'}, {'ForeName': 'Jiachan', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: jiacanlu0613@163.com.'}, {'ForeName': 'Ruixing', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: zhuruixin07@126.com.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: xiaoc0105@126.com.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China. Electronic address: feirlu@163.com.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.09.003']
1361,33075644,Additive effectiveness and feasibility of a theory-driven instant assessment and feedback system in brief cannabis intervention: A randomised controlled trial.,"Assessment and personalised feedback are important components of brief interventions (BIs) for cannabis use. A key outcome is to increase motivation to change during this short interaction. The diversity of available assessments and time burden scoring them pose a challenge for routine use in clinical practice. An instant assessment and feedback (iAx) system was developed to administer assessments informed by bioSocial Cognitive Theory, that were instantly scored and benchmarked against clinical norms, to provide patient feedback and guide treatment planning. This study evaluated the feasibility and additive effectiveness of the iAx on motivation to change cannabis use, when compared to treatment as usual (TAU), in a single-session BI. A randomised controlled trial was conducted in a public hospital alcohol and drug outpatient clinic. Eighty-seven cannabis users (M age  = 26.41; 66% male) were assigned to the BI utilising the iAx (iAx; n = 44) or to the standard BI (TAU; n = 43). Patients completed pre- and post-BI assessments of motivation to change and a post-BI measure of treatment satisfaction. Practitioners completed a feedback survey. Patients receiving iAx reported a significantly greater increase in motivation to change from pre- to post-BI compared to patients receiving TAU (d = 0.49, p = .03). Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57). Practitioners also reported a high level of satisfaction with the iAx system. In summary, findings support the feasibility and additive effectiveness of the iAx to enhance patient motivation during cannabis BI.",2020,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","['Eighty-seven cannabis users (M age \xa0=\xa026.41; 66% male', 'brief cannabis intervention', 'public hospital alcohol and drug outpatient clinic']",['theory-driven instant assessment and feedback system'],"['Treatment satisfaction', 'motivation']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",87.0,0.0509742,"Treatment satisfaction was high across both conditions, with no significant difference between groups (p = .57).","[{'ForeName': 'Zoë E', 'Initials': 'ZE', 'LastName': 'Papinczak', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; School of Psychology, The University of Queensland, Brisbane, QLD 4072, Australia.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Connor', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Discipline of Psychiatry, School of Medicine, The University of Queensland, Brisbane, QLD 4029, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Gerald F X', 'Initials': 'GFX', 'LastName': 'Feeney', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gullo', 'Affiliation': 'National Centre for Youth Substance Use Research, The University of Queensland, Brisbane, QLD 4072, Australia; Alcohol and Drug Assessment Unit, Princess Alexandra Hospital, Brisbane, QLD 4102, Australia. Electronic address: m.gullo@uq.edu.au.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106690']
1362,33081705,Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis.,"BACKGROUND


Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD.
METHODS


This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy.
DISCUSSION


This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD.
TRIAL REGISTRATION


NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).",2020,"CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients.","['Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms', '126 participants treated with HD in community-based dialysis facilities with chronic insomnia', 'patients receiving maintenance HD', 'HD patients', 'patients undergoing hemodialysis', 'patients treated with HD']","['existing insomnia therapies', 'medications (trazodone', 'telehealth CBT-I, trazodone, or medication placebo', 'trazodone, or medication placebo', 'Cognitive-behavioral therapy']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0569076,"CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Unruh', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA. MUnruh@salud.unm.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cukor', 'Affiliation': 'The Rogosin Institute, New York, NY, USA.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rue', 'Affiliation': 'Center for Biomedical Statistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Abad', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Maria-Eleni', 'Initials': 'ME', 'LastName': 'Roumelioti', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McCurry', 'Affiliation': 'Child, Family, and Population Health Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Heagerty', 'Affiliation': 'Center for Biomedical Statistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Mehrotra', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington, Seattle, WA, USA.'}]",BMC nephrology,['10.1186/s12882-020-02107-x']
1363,33070009,A trial of buspirone for anxiety in Parkinson's disease: Safety and tolerability.,"INTRODUCTION


In Parkinson's disease (PD), anxiety is common, associated with lower health-related quality of life, and undertreated. The primary objective of this study was to determine the tolerability of buspirone for the treatment of anxiety in PD.
METHODS


Individuals with PD and clinically significant anxiety were randomized 4:1 to flexible dosage buspirone or placebo for 12 weeks. Treatment was initiated at 7.5 mg twice daily and titrated based on response and tolerability to an optimal dosage (maximum 30 mg twice daily). The primary outcome was the proportion of participants who failed to complete the study on study drug. Secondary outcomes included adverse events, dosage reductions, motor function, dyskinesias, and anxiety.
RESULTS


A total of 21 participants enrolled, 4 were randomized to placebo and 17 to buspirone (mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic). In the buspirone group, 7 (41%) failed to complete the study on drug, 5 due to intolerability. The median buspirone dosage was 7.5 mg twice daily. No serious adverse events occurred. A total of 9 (53%) buspirone participants experienced adverse events consistent with worsened motor function. In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
CONCLUSION


Tolerability concerns do not support moving immediately forward with a large-scale efficacy trial. However, concomitant anxiolytics may have affected tolerability and a signal of efficacy was seen suggesting that future studies of buspirone monotherapy be considered.",2020,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[""Parkinson's disease"", 'Individuals with PD and clinically significant anxiety', 'mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic', 'A total of 21 participants enrolled, 4 were randomized to']","['flexible dosage buspirone or placebo', 'placebo', 'buspirone']","['Parkinson Anxiety Scale', 'adverse events', 'tolerability', 'Hamilton Anxiety Rating Scale', 'adverse events, dosage reductions, motor function, dyskinesias, and anxiety']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",21.0,0.0671081,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[{'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: ruth_schneider@urmc.rochester.edu.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health and Technology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box 694, Rochester, NY, USA. Electronic address: peggy.auinger@chet.rochester.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Tarolli', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: christopher_tarolli@urmc.rochester.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Iourinets', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: jiourine@u.rochester.edu.'}, {'ForeName': 'María Cristina', 'Initials': 'MC', 'LastName': 'Gil-Díaz', 'Affiliation': 'Department of Neuroscience, University of Rochester, 500 Joseph C. Wilson Blvd, Rochester, NY, 14627, USA. Electronic address: mgildiaz@u.rochester.edu.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: irene_richard@urmc.rochester.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.020']
1364,33070045,Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.,"OBJECTIVE


Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors.
METHODS


Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data.
RESULTS


Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels.
CONCLUSION


Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.",2020,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","['Seventy-seven participants', 'cancer survivors', 'Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue', 'fatigued cancer survivors']","['light therapy intervention', 'bright white light (BWL) or dim red light (DRL) device']","['diurnal cortisol slopes nor total cortisol output', 'Diurnal cortisol slopes and total cortisol output', 'total cortisol output', 'steepness in cortisol slope', 'fatigue and salivary cortisol', 'diurnal salivary cortisol', 'diurnal cortisol slopes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",77.0,0.241495,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","[{'ForeName': 'Jillian A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, State College, PA, USA. Electronic address: jaj53@psu.edu.'}, {'ForeName': 'Utkarsh', 'Initials': 'U', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: utkarsh.subnis@ucalgary.ca.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: lcarlso@ucalgary.ca.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University, St. John's, Newfoundland, Canada. Electronic address: sheila.garland@mun.ca.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Santos-Iglesias', 'Affiliation': 'Department of Psychology, Cape Breton University, Sydney, NS, Canada. Electronic address: pablo_santos@cbu.ca.'}, {'ForeName': 'Katherine-Ann L', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: klpiedal@ucalgary.ca.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Deleemans', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Division of Medical Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: julie.deleemans@ucalgary.ca.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110266']
1365,33070053,"Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL).","OBJECTIVES


Progression-free survival (PFS) and response rate to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) varies in patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations, suggesting that other genetic alterations may influence oncogene addiction. Low BRCA1 mRNA levels correlate with longer PFS in erlotinib-treated EGFR-mutant NSCLC patients. Since the poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib, may attenuate and/or prevent BRCA1 expression, the addition of olaparib to gefitinib could improve outcome in EGFR-mutant advanced NSCLC.
MATERIALS AND METHODS


GOAL was a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.
RESULTS


Between September 2013, and July 2016, 182 patients underwent randomization, 91 received gefitinib and 91 received gefitinib plus olaparib. There were no differences in gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation. Median PFS was 10.9 months (95 % CI 9.3-13.3) in the gefitinib arm and 12.8 months (95 % CI 9.1-14.7) in the gefitinib plus olaparib arm (HR 1.38, 95 % CI 1.00-1.92; p = 0.124). The most common adverse events were anemia, 78 % in gefitinib plus olaparib group, 38 % in gefitinib arm, diarrhea, 65 % and 60 %, and fatigue, 40 % and 32 %, respectively.
CONCLUSIONS


The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone. The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.",2020,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","['182 patients underwent randomization, 91 received', 'Between September 2013, and July 2016', 'patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations', 'two countries, Spain and Mexico', 'EGFR mutant non-small-cell lung cancer (NSCLC', 'Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease']","['gefitinib 250\u202fmg daily or gefitinib 250\u202fmg daily plus olaparib 200\u202fmg three times daily in 28-day cycles', 'epidermal growth factor receptor', 'EGFR) tyrosine kinase inhibitors (TKIs', 'gefitinib', 'gefitinib plus olaparib', 'gefitinib and olaparib versus gefitinib alone']","['diarrhea', 'Median PFS', 'hematological and gastrointestinal toxicity', 'PFS', 'overall survival (OS), response rate, safety and tolerability', 'gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",182.0,0.184564,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Campelo', 'Affiliation': 'University Hospital A Coruña (XXIAC-SERGAS), A Coruña, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Alicante University Hospital, Alicante, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Hospital Universitario Insular De Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ana Laura Ortega', 'Initials': 'ALO', 'LastName': 'Granados', 'Affiliation': 'Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lianes', 'Affiliation': 'Hospital de Mataró, Mataró, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Catalan Institute of Oncology (ICO) and Girona Biomedical Research Institute (IDIBGi), Girona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Reguart', 'Affiliation': ""Hospital Clínic Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Guirado', 'Affiliation': 'Hospital General de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Sala', 'Affiliation': 'Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vázquez-Estevez', 'Affiliation': 'Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Reyes Bernabé', 'Initials': 'RB', 'LastName': 'Caro', 'Affiliation': 'Hospital Virgen Del Rocio, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Drozdowskyj', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Verdú', 'Affiliation': 'Spanish Lung Cancer Group Office, Barcelona, Spain.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Karachaliou', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Molina-Vila', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain. Electronic address: rrosell@iconcologia.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.018']
1366,33070057,Salivary measurement and mindfulness-based modulation of prescription opioid cue-reactivity.,"BACKGROUND


Chronic pain patients on long-term opioid therapy (LTOT) may be at elevated risk for developing conditioned opioid cue-reactivity as their prescribed dosing schedules simultaneously function as fixed reinforcement schedules. Since opioids are typically consumed orally during LTOT, it stands to reason that opioid cue exposure might elicit conditioned salivary responses. However, no study has examined salivary cue-reactivity among opioid users during in-vivo exposure to their own prescription opioid medication.
METHODS


Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics. Study 1 aimed to determine whether chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid. Study 2 was a pilot study that aimed to assess the effects of behavioral treatment on chronic pain patients' salivary cue-reactivity.
RESULTS


In Study 1, exposure to the patient's own prescribed opioid resulted in significantly greater increases in salivation and cue-elicited craving than exposure to a neutral cue. In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
CONCLUSIONS


Study findings demonstrate salivation may serve as a useful, objective index of opioid cue-reactivity. With further refinement of this task, conditioned salivary response could be used to identify especially vulnerable patients, who then could be targeted with a personalized medicine approach for selective and intensive prevention/treatment interventions to preempt escalation of opioid use to opioid misuse and OUD.",2020,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","['chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid', 'Chronic pain patients on long-term', ""chronic pain patients' salivary cue-reactivity"", 'Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics']","['8-week Mindfulness-Oriented Recovery Enhancement intervention', 'behavioral treatment', 'opioid therapy (LTOT']","['salivation and cue-elicited craving', 'opioid cue-reactivity', 'salivation and craving ratings']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",2.0,0.0378235,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States; Salt Lake City Veterans Administration Medical Center, United States. Electronic address: eric.garland@socwk.utah.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108351']
1367,33075170,"A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.","AIMS


This study investigated the safety, tolerability and pharmacokinetics after administration of a specific Cannabis sativa cultivar extract, standardised to cannabidiol (CBD) content as sublingual wafer or oil formulation compared to nabiximols oromucosal spray.
METHODS


For the single-dose study, the design was an open-label, 4-way crossover in 12 healthy volunteers randomised to receive a sequence of 4 different single doses of CBD as a sublingual wafer (25 or 50 mg CBD), oil solution (50 mg CBD), or nabiximols oromucosal spray (20 mg CBD, 21.6 mg tetrahydrocannabinol). For the multiple-dose study, sublingual wafer (50 mg CBD) was administered twice a day for 5 days.
RESULTS


The extract was generally well tolerated by participants when administered in either wafer or oil form, with some adverse events, including mild or moderate somnolence, sedation and altered mood. The relative bioavailability of CBD after administration as a sublingual wafer was comparable with that of oil solution with 90% confidence interval of 83-131%. The median maximum concentrations of CBD after administration of oil solution and wafer was 9.4 and 11.9 ng mL -1  , respectively. Maximum concentrations of CBD occurred 4 hours after administration, with an estimated terminal elimination half-life of 6 hours. There was no statistically significant difference between the AUC 0-τ  of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray.
CONCLUSION


Oil solution and sublingual wafer formulations of the extract standardised with CBD were well tolerated and achieved equivalent concentrations of CBD when compared to an available commercial nabiximols formulation.",2020,"There was no statistically significant difference between the AUC 0-t  of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray.
","['12 healthy volunteers', 'Healthy Volunteers']","['oil solution (50 mg CBD), or nabiximols oromucosal spray', 'oil solution', 'Oil solution', 'CBD']","['relative bioavailability of CBD', 'Safety, Tolerability, and Pharmacokinetics', 'median maximum concentrations of CBD', 'Maximum concentrations of CBD', 'tolerated and achieved equivalent concentrations of CBD', 'mild or moderate somnolence, sedation and altered mood', 'safety, tolerability, and PK']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C1273657', 'cui_str': 'Oromucosal spray'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]",12.0,0.080618,"There was no statistically significant difference between the AUC 0-t  of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray.
","[{'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Hosseini', 'Affiliation': 'BOD Australia Pty Ltd, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network Pty Ltd, Melbourne, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.14617']
1368,33075179,Randomized control trial of oral arginine therapy for children with sickle cell anemia hospitalized for pain in Nigeria.,"Low arginine bioavailability is associated with vaso-occlusive painful crisis (VOC) severity in sickle cell anemia (SCA) and predicts need for pediatric hospitalization. Intravenous arginine therapy has opioid-sparing effects and was found to significantly decrease pain scores in children hospitalized with SCA-VOC in a phase-two randomized placebo-controlled trial (RCT). Efficacy of oral arginine is unknown. Our objective was to determine the safety and efficacy of oral arginine therapy in Nigerian children with SCA. A double-blind RCT of oral L-arginine-hydrochloride (100 mg/kg TID) was conducted in children with SCA-VOC, aged 5-17 years, hospitalized at two Nigerian sites. The primary outcome measure was analgesic usage, quantified by difference in the mean Analgesic Medication Quantification Scale (MQS). Secondary outcomes included daily pain scores, time-to-crisis-resolution and length-of-hospital-stay. An intention-to-treat analysis was performed. Sixty-eight children (age 5-17 years, mean 10.6 ± 0.4 years; 56% male), were randomized to receive L-arginine (35 patients) or placebo (33 patients). The mean total MQS for the arginine group was 73.4 (95% CI, 62.4-84.3) vs 120.0 (96.7-143.3) for placebo (P < .001). The mean rate of decline in worst pain scores was faster in the arginine arm vs placebo (1.50 [1.23-1.77] vs 1.09 [0.94-1.24] point/d, P = .009). Children receiving arginine had a shorter time-to-crisis-resolution (P = .02), shorter hospital-stay (P = .002) and experienced no serious adverse event. Pain control was more rapid, total analgesic requirement was significantly reduced, and most notably, time-to-crisis-resolution and length-of-hospital-stay were shorter in children with SCA-VOC receiving arginine vs placebo. Given the established safety and low cost, oral arginine is a promising adjuvant therapy for SCA-VOC management.",2020,"Children receiving arginine had a shorter time-to-crisis-resolution (p=0.02), shorter hospital-stay (p=0.002) and experienced no serious adverse event.","['mean 10.6±0.4\u2009years; 56% male', 'children with SCA-VOC, aged 5-17\u2009years, hospitalized at 2 Nigerian sites', 'Nigerian children with SCA', 'Sixty-eight children (age 5-17years', 'sickle cell anemia (SCA', 'Children with Sickle Cell Anemia Hospitalized for Pain in Nigeria', 'children hospitalized with SCA-VOC']","['oral arginine therapy', 'Intravenous arginine therapy', 'oral arginine', 'oral  L  -arginine-hydrochloride', 'Oral Arginine Therapy', 'placebo', 'L  -arginine']","['Pain control', 'mean total MQS', 'total analgesic requirement', 'analgesic usage, quantified by difference in the mean Analgesic Medication Quantification Scale (MQS', 'safety and efficacy', 'shorter time-to-crisis-resolution', 'shorter hospital-stay', 'pain scores', 'time-to-crisis-resolution and length-of-hospital-stay', 'mean rate of decline in worst pain scores', 'daily pain scores, time-to-crisis-resolution and length-of-hospital-stay']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",68.0,0.351062,"Children receiving arginine had a shorter time-to-crisis-resolution (p=0.02), shorter hospital-stay (p=0.002) and experienced no serious adverse event.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Onalo', 'Affiliation': 'Department of Paediatrics, Faculty of Clinical Sciences, University of Abuja, Gwagwalada, Nigeria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooper', 'Affiliation': 'Department of Paediatrics, Faculty of Clinical Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Cilliers', 'Affiliation': 'Department of Paediatrics, Chris Hani Baragwanath Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Barend C', 'Initials': 'BC', 'LastName': 'Vorster', 'Affiliation': 'Centre for Human Metabolomics, North West University, Potchefstroom, South Africa.'}, {'ForeName': 'Nnebe-Agumadu', 'Initials': 'NA', 'LastName': 'Uche', 'Affiliation': 'Department of Paediatrics, Faculty of Clinical Sciences, University of Abuja, Gwagwalada, Nigeria.'}, {'ForeName': 'Oniyangi O', 'Initials': 'OO', 'LastName': 'Oluseyi', 'Affiliation': 'Department of Pediatrics, National Hospital, Abuja, Nigeria.'}, {'ForeName': 'Victoria D', 'Initials': 'VD', 'LastName': 'Onalo', 'Affiliation': 'Emergency Paediatric Pharmacy, University of Abuja Teaching Hospital, Gwagwalada, Nigeria.'}, {'ForeName': 'Yunusa', 'Initials': 'Y', 'LastName': 'Zubairu', 'Affiliation': 'Emergency Paediatric Pharmacy, University of Abuja Teaching Hospital, Gwagwalada, Nigeria.'}, {'ForeName': 'Alice U', 'Initials': 'AU', 'LastName': 'Ayodele-Kehinde', 'Affiliation': 'Department of Pharmacy, University of Abuja Teaching Hospital, Gwagwalada, Nigeria.'}, {'ForeName': 'Oladimeji M', 'Initials': 'OM', 'LastName': 'Damilare', 'Affiliation': 'Independent Consultant, Abuja, Nigeria.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Biostatistical Core, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Division of Pediatric Emergency Medicine, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",American journal of hematology,['10.1002/ajh.26028']
1369,33079877,Arterial Catheters for Early Detection and Treatment of Hypotension During Major Noncardiac Surgery: A Randomized Trial.,"BACKGROUND


Continuous blood pressure monitoring may facilitate early detection and prompt treatment of hypotension. We tested the hypothesis that area under the curve (AUC) mean arterial pressure (MAP) <65 mm Hg is reduced by continuous invasive arterial pressure monitoring.
METHODS


Adults having noncardiac surgery were randomly assigned to continuous invasive arterial pressure or intermittent oscillometric blood pressure monitoring. Arterial catheter pressures were recorded at 1-minute intervals; oscillometric pressures were typically recorded at 5-minute intervals. We estimated the arterial catheter effect on AUC-MAP <65 mm Hg using a multivariable proportional odds model adjusting for imbalanced baseline variables and duration of surgery. Pressures <65 mm Hg were categorized as 0, 1-17, 18-91, and >91 mm Hg × minutes of AUC-MAP <65 mm Hg (ie, no hypotension and 3 equally sized groups of increasing hypotension).
RESULTS


One hundred fifty-two patients were randomly assigned to arterial catheter use and 154 to oscillometric monitoring. For various clinical reasons, 143 patients received an arterial catheter, while 163 were monitored oscillometrically. There were a median [Q1, Q3] of 246 [187, 308] pressure measurements in patients with arterial catheters versus 55 (46, 75) measurements in patients monitored oscillometrically. In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006). The result was robust over an as-treated analysis and for sensitivity analyses with thresholds of 60 and 70 mm Hg.
CONCLUSIONS


Intraoperative blood pressure monitoring with arterial catheters detected nearly twice as much hypotension as oscillometric measurements.",2020,"In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006).","['Adults having noncardiac surgery', 'One hundred fifty-two patients', '143 patients received an arterial catheter, while 163 were monitored oscillometrically', 'Hypotension During Major Noncardiac Surgery']","['continuous invasive arterial pressure or intermittent oscillometric blood pressure monitoring', 'arterial catheter use and 154 to oscillometric monitoring', 'AUC-MAP']","['hypotension', 'Arterial catheter pressures', 'area under the curve (AUC) mean arterial pressure (MAP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0428890', 'cui_str': 'Invasive arterial pressure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",152.0,0.286559,"In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Naylor', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Suleiman', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reville', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Cote', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Hutcherson', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Bianka M', 'Initials': 'BM', 'LastName': 'Nguyen', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elsharkawy', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'From the Departments of Outcomes Research.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004370']
1370,33079883,Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial.,"BACKGROUND


Intraoperative monitoring with pupillometry has shown promising results for nociception/antinociception balance monitoring. However, its benefits in clinical practice remain unproven. The aim of this study was to evaluate the efficacy of intraoperative pupillometry monitoring on intraoperative opioid consumption and postoperative pain compared to surgical pleth index (SPI), another widely investigated monitoring.
METHODS


American Society of Anesthesiologists (ASA) I-II patients scheduled for elective laparoscopic cholecystectomy were included. This prospective, parallel-arm, single-center study was conducted in 2 steps. First, we evaluated the feasibility of using pupillometry and SPI monitoring compared with conventional hemodynamic monitoring. Next, a parallel-arm, double-blind randomized study compared the peak postoperative pain measured with numerical rating scale (NRS) from 0 (no pain) to 10 (extreme pain) as a primary outcome between pupillometry (pupillometry group, n = 43) and SPI monitoring (SPI group, n = 43) using Mann-Whitney U test. Secondary outcomes included intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications.
RESULTS


In the preliminary study (n = 50), remifentanil consumption was less under pupillometry monitoring compared to SPI monitoring, and peak postoperative pain was lower under pupillometry compared to conventional monitoring. In the main study (n = 86), peak postoperative pain and intraoperative remifentanil consumption were lower in the pupillometry group (median [first to third quartile], 5 [4-6]; mean ± standard deviation [SD], 0.078 ± 0.019 μg·kg·minute) compared to the SPI group (7 [5-8] and 0.0130 ± 0.051 μg·kg·minute; P < .001), with the median difference in peak postoperative pain of -1 and its 95% confidence interval between -2 and -0.5. The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
CONCLUSIONS


Intraoperative pupillometry monitoring reduced intraoperative remifentanil consumption and postoperative pain. It may be an alternative option for intraoperative opioid control under general anesthesia in adult patients.",2020,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","['adult patients', 'American Society of Anesthesiologists (ASA']","['surgical pleth index (SPI', 'elective laparoscopic cholecystectomy', 'intraoperative pupillometry monitoring', 'pupillometry and SPI monitoring', 'conventional hemodynamic monitoring', 'Pupillometry With Surgical Pleth Index Monitoring', 'Propofol-Remifentanil Anesthesia']","['better responsiveness to fentanyl', 'intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications', 'Perioperative Opioid Consumption and Nociception', 'intraoperative opioid consumption and postoperative pain', 'peak postoperative pain measured with numerical rating scale (NRS', 'peak postoperative pain and intraoperative remifentanil consumption', 'peak postoperative pain', 'number of analgesic administrations', 'intraoperative remifentanil consumption and postoperative pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.251762,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","[{'ForeName': 'Jong Hae', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Jwa', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Choung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Yeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004958']
1371,33087054,"Improving knowledge, self-efficacy and collective efficacy regarding the Brazilian dietary guidelines in primary health care professionals: a community controlled trial.","BACKGROUND


Capacity-building of health professionals regarding to nutrition is a strategy for qualifying public health work to promote healthy diets in primary health care (PHC) services.
OBJECTIVE


To evaluate the effect of an intervention based on Brazilian Dietary Guidelines (BDG) on the knowledge, self-efficacy (SE) and collective efficacy (CE) of interprofessional teams working in PHC.
METHODS


It refers to a pre-post intervention study involving 24 health professionals divided into a control group (CG) and intervention (IG). The IG received a 16-h educational workshop on the BDG, guided by a validated protocol. Knowledge, SE and CE for using the BDG were assessed via a self-administered scale, ranging from 0 to 16 and 0 to 36 points, respectively; the scale was previously validated, completed before and after 2 months of the intervention. The effects of the intervention were estimated by paired t-test for intragroup comparisons over time.
RESULTS


The mean difference in the knowledge and SE scores of the IG pre- and post-intervention was 2.0 (CI 0.49-3.51) and 6.75 (CI 4.05-9.45) points, respectively. These results means the IG participants obtained 59 and 52.8% more points in knowledge and in SE in relation to CG, with significative difference (p = 0.007 and p <  0.00, respectively). There was no significant variation in the CE scores in both groups.
CONCLUSIONS


Considering the results presented and due to the originality of the study in question, the educational workshop was effective in increasing the knowledge and SE of professionals working in PHC in using the Dietary Guidelines in their work routines. These findings can assist other research in developing nutrition interventions with interprofessional teams.",2020,"There was no significant variation in the CE scores in both groups.
","['24 health professionals divided into a', 'primary health care professionals']","['Brazilian Dietary Guidelines (BDG', 'Brazilian dietary guidelines', '16-h educational workshop', 'control group (CG) and intervention (IG']","['knowledge, self-efficacy (SE) and collective efficacy (CE', 'knowledge and SE scores', 'CE scores', 'Improving knowledge, self-efficacy and collective efficacy']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",24.0,0.0252014,"There was no significant variation in the CE scores in both groups.
","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Tramontt', 'Affiliation': 'Nutrition in Public Health Postgraduate Program, School of Public Health, University of São Paulo, Av. Dr. Arnaldo 715, São Paulo, SP, 01246-904, Brazil. claudiartramontt@gmail.com.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Jaime', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, Av. Dr. Arnaldo 715, São Paulo, SP, 01246-904, Brazil.'}]",BMC family practice,['10.1186/s12875-020-01245-3']
1372,33078978,Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209).,"PURPOSE


Limitations of the paclitaxel-doxorubicin-cisplatin (TAP) regimen in the treatment of endometrial cancer include tolerability and cumbersome scheduling. The Gynecologic Oncology Group studied carboplatin plus paclitaxel (TC) as a noninferior alternative to TAP.
METHODS


GOG0209 was a phase III, randomized, noninferiority, open-label trial. Inclusion criteria were stage III, stage IV, and recurrent endometrial cancers; performance status 0-2; and adequate renal, hepatic, and marrow function. Prior radiotherapy and/or hormonal therapy were permitted, but chemotherapy, including radiosensitization, was not. Patients were treated with doxorubicin 45 mg/m 2  and cisplatin 50 mg/m 2  (day 1), followed by paclitaxel 160 mg/m 2  (day 2) with granulocyte colony-stimulating factor or paclitaxel 175 mg/m 2  and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles. The primary endpoint was overall survival (OS; modified intention to treat). Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity were secondary endpoints.
RESULTS


From 2003 to 2009, 1,381 women were enrolled. Noninferiority of TC to TAP was concluded for OS (median, 37  v  41 months, respectively; hazard ratio [HR], 1.002; 90% CI, 0.9 to 1.12), and PFS (median, 13  v  14 months; HR, 1.032; 90% CI, 0.93 to 1.15). Neutropenic fever was reported in 7% of patients receiving TAP and 6% of those receiving TC. Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC ( P  = .40). More grade ≥ 3 thrombocytopenia (23%  v  12%), vomiting (7%  v  4%), diarrhea (6%  v  2%), and metabolic (14%  v  8%) toxicities were reported with TAP. Neutropenia (52%  v  80%) was more common with TC. Small HRQoL differences favored TC.
CONCLUSION


With demonstrated noninferiority to TAP, TC is the global first-line standard for advanced endometrial cancer.",2020,Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC ( P  = .40).,"['From 2003 to 2009, 1,381 women were enrolled', 'Advanced Endometrial Cancer', 'Inclusion criteria were stage III, stage IV, and recurrent endometrial cancers; performance status 0-2; and adequate renal, hepatic, and marrow function']","['Carboplatin and Paclitaxel', 'carboplatin plus paclitaxel (TC', 'TC to TAP', 'paclitaxel 160 mg/m 2  (day 2) with granulocyte colony-stimulating factor or paclitaxel 175 mg/m 2  and carboplatin', 'paclitaxel-doxorubicin-cisplatin (TAP', 'Prior radiotherapy and/or hormonal therapy', 'doxorubicin 45 mg/m 2  and cisplatin']","['Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity', 'diarrhea', 'PFS', 'Neutropenia', 'overall survival (OS; modified intention to treat', 'grade ≥ 3 thrombocytopenia', 'Neutropenic fever', 'vomiting', 'Grade > 2 sensory neuropathy', 'toxicities']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0278802', 'cui_str': 'Endometrial cancer recurrent'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",1381.0,0.0759159,Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC ( P  = .40).,"[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Virginia L', 'Initials': 'VL', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'The Peggy and Charles Stephenson Cancer Center, The University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Cohn', 'Affiliation': 'Arthur G. James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Ehime University School of Medicine, Ehime, Japan.'}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'Division of Obstetrics and Gynecology, University of California, Irvine Medical Center, Orange, CA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': 'Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Argenta', 'Affiliation': 'University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': 'Gynecologic Oncology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Zweizig', 'Affiliation': 'University of Massachusetts Memorial Medical Center, Worcester, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Warshal', 'Affiliation': 'Cooper Hospital/University Medical Center, Camden, NJ.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Hanjani', 'Affiliation': 'Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Carney', 'Affiliation': 'John A. Burns School of Medicine, University of Hawaii Cancer Center, Honolulu, HI.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zaino', 'Affiliation': 'Penn State University, Hershey, PA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'The University of Chicago Medicine, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01076']
1373,33079066,"Intervention to Improve Preschool Children's Fundamental Motor Skills: Protocol for a Parent-Focused, Mobile App-Based Comparative Effectiveness Trial.","BACKGROUND


Preschool age is an important time to master fundamental motor skills (FMS) through structured physical activity, yet many young children lag behind in motor skill development.
OBJECTIVE


The Promoting Lifelong Activity in Youth (PLAY) study is a pilot comparative effectiveness trial to test the acceptability, feasibility, and preliminary effectiveness of a mobile app delivered to parents to promote FMS development in their preschool children (aged 3-5 years).
METHODS


We conducted a 2-arm, parallel-design, randomized comparative effectiveness trial in 72 parent-child dyads from the southeastern United States. Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play). Primary outcomes are feasibility and acceptability of the app and child's FMS measured at end of intervention (week 12). Exploratory outcomes are child's objective physical activity, perceived movement competence, and parent report of self-regulation at the end of treatment (week 12) and sustained outcomes at follow-up (week 24).
RESULTS


This project was funded in September 2018, with institutional review board approval in August 2018. Data collection took place from May 2019 through February 2020. To date, the project team has completed data collection on 69 preschool-age children, and results are expected to be published by 2021.
CONCLUSIONS


The PLAY study examines the feasibility and preliminary effectiveness of a mobile app, parent-led curricula to promote FMS proficiency for preschool children. If found to be effective, the app has the potential for wide-scale dissemination to parents of preschoolers and to provide a model for the utilization of mobile apps to promote young children's motor skill development.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03901300; https://clinicaltrials.gov/ct2/show/NCT03901300.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19943.",2020,"Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play).","['preschool children (aged 3-5 years', 'preschool children', '72 parent-child dyads from the southeastern United States', '69 preschool-age children']","['mobile app, parent-led curricula', 'FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play', 'mobile app delivered to parents to promote FMS development']","[""child's objective physical activity, perceived movement competence, and parent report of self-regulation"", ""feasibility and acceptability of the app and child's FMS""]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",,0.0622129,"Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play).","[{'ForeName': 'E Kipling', 'Initials': 'EK', 'LastName': 'Webster', 'Affiliation': 'Institute of Public and Preventive Health, Augusta University, Augusta, GA, United States.'}, {'ForeName': 'Chelsea L', 'Initials': 'CL', 'LastName': 'Kracht', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Newton', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Staiano', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}]",JMIR research protocols,['10.2196/19943']
1374,33075197,Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study.,"OBJECTIVE


To compare the safety and efficacy of 10% sinecatechins (Veregen ®  ) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN).
DESIGN


A Phase II double-blind randomised control trial.
SETTING


A tertiary gynaecological oncology referral centre.
POPULATION


All women diagnosed with primary and recurrent uVIN.
METHODS


Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied three times daily for 16 weeks) and were followed up at 2, 4, 8, 16, 32 and 52 weeks.
MAIN OUTCOME MEASURES


The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores.
RESULTS


There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n = 5) or partial (n = 8) CR, when best CR was evaluated. In placebo group, three patients had complete CR, two had partial CR, six had stable disease and two were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared with the placebo group (P = 0.002). There was no difference in toxicity reported in either group.
CONCLUSION


Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study.
TWEETABLE ABSTRACT


A randomised control study indicating that sinecatechins ointment may be a novel treatment for uVIN.",2020,Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002).,"['usual type vulval intraepithelial neoplasia', 'Eligible patients', '26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n=5) or partial (n=8) CR', 'usual type vulvar intraepithelial neoplasia (uVIN', 'All women diagnosed with primary and recurrent uVIN', 'A tertiary gynaecological oncology referral center']","['10% sinecatechins (Veregen®) ointment against placebo', 'placebo', 'Sinecatechins ointment', 'sinecatechins or placebo ointment']","['HR', 'safety and efficacy', 'histological response (HR', 'clinical (CR) response, toxicity, quality of life and pain scores', 'CR', 'toxicity']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0346210', 'cui_str': 'Dysplasia of vulva'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960121', 'cui_str': 'Sinecatechins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0495107', 'cui_str': 'Vulval intraepithelial neoplasia grade 2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1960121', 'cui_str': 'Sinecatechins'}, {'cui': 'C1816306', 'cui_str': 'Veregen'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.68127,Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared to the placebo group (P=0.002).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yap', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Slade', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Goddard', 'Affiliation': 'Pan Birmingham Gynaecological Cancer Centre, City Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dawson', 'Affiliation': 'Department of Microbiology & Infection, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ganesan', 'Affiliation': ""Department of Histopathology, Birmingham Women's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Velangi', 'Affiliation': 'Department of Dermatology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sahu', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Luesley', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16574']
1375,33080291,Effects of nicotine on pupil size and performance during multiple-object tracking in non-nicotine users.,"Nicotine has been commonly used in pyschopharmacological studies, showing its benefits as a pharmacological stimulant on cognitive performance. In the current study, we investigated the effects of 2 mg (Experiment 1) and 4 mg (Experiment 2) of nicotine on performance on a multiple-object-tracking task. Participants were young non-smoking adults with no pre-existing attentional deficits. Nicotine and placebo were administered through nicotine and nicotine-free taste-matched chewing gum, respectively. Additionally, we compared pupil size between nicotine and placebo conditions in both experiments. Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance. We speculate that nicotine might enhance performance only for certain cognitive functions, and only for specific populations, such as nicotine-deprived smokers.",2020,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","['Participants were young non-smoking adults with no pre-existing attentional deficits', 'non-nicotine users']","['nicotine', 'Nicotine', 'nicotine and nicotine-free taste-matched chewing gum', 'Nicotine and placebo']","['behavioural performance', 'pupil size and performance during multiple-object tracking', 'pupil size']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4302494', 'cui_str': 'Nicotine user'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]",,0.0190549,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","[{'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Wardhani', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway; Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands; Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium. Electronic address: intankusuma.wardhani@ugent.be.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathôt', 'Affiliation': 'Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Boehler', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.09.005']
1376,33080294,The effects of an internet-based mindfulness meditation intervention on electrophysiological markers of attention.,"Evidence suggests that mindfulness meditation training has the potential to train aspects of attention. However, the neurophysiological mechanisms underpinning the attentional benefits from mindfulness remain unclear. This randomized controlled trial examined changes in electrophysiological markers of attention before and after completion of a 6-week internet-based mindfulness intervention. EEG and ERP data were collected from 64 generally healthy, mildly stressed older adults. Participants were randomized to an internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a waitlist control condition. Attentional N2 and P3 evoked potentials were derived from active and passive auditory oddball paradigms. Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls. There were no significant relationships between the intervention and N2 potentials. Our data demonstrate a measurable increase in attentional control when discriminating or directing attention away from auditory stimuli for older adult participants who received mindfulness training. These findings lend support to the use of the P3 as a neurophysiological measure of meditation engagement and intervention efficacy.",2020,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"['64 generally healthy, mildly stressed older adults']","['internet-based mindfulness meditation intervention', 'mindfulness meditation training', 'internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition', '6-week internet-based mindfulness intervention']","['attentional control', 'P3 peak-trough amplitude', 'Attentional N2 and P3 evoked potentials']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",64.0,0.0204774,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Klee', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America. Electronic address: klee@ohsu.edu.'}, {'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, United States of America.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America; Oregon Health & Science University, Departments of Behavioral Neuroscience and Biomedical Engineering, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.002']
1377,33083903,"Metasul vs Cerasul bearings: a prospective, randomized study at a mean eighteen years.","BACKGROUND


The aims of our study were to compare the clinical, radiographic outcomes and survivals between second-generation metal-on-metal (Metasul) and ceramic-on-ceramic (Cerasul) bearings at a very long-term follow-up.
METHODS


A prospective, randomized study was originally performed on a consecutive series of 250 cementless, 28-mm head and primary total hip arthroplasties between 1999 and 2002. For each bearing (Metasul or Cerasul), 125 THAs were initially included. All cases were evaluated both clinically and radiographically, and survival was assessed, considering revisions for aseptic loosening or for any reason as the end points for failure.
RESULTS


At a mean 18-year follow-up, clinical and radiographic outcomes were similar. Harris Hip Score increased 30% in the Metasul group and 32% in the Cerasul group (p = 0.6). Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04). Survival free of any revision was 91% ([CI 84-98%]) for Cerasul and 91% ([CI 84-98%]) for Metasul. Fractures of Cerasul insert occurred in four cases (3%) at a mean 12.5 ± 3.3 years (range, 6 to 17 years).
CONCLUSION


At 18 years, Cerasul demonstrated higher survivorship than Metasul considering aseptic loosening as an end point. However, Cerasul liners had high rate of fracture because of its sandwich design (thin ceramic liner into polyethylene). These implants are no more available on the market.",2020,"Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04).","['mean eighteen years', 'consecutive series of 250 cementless, 28-mm head and primary total hip arthroplasties between 1999 and 2002']","['second-generation metal-on-metal (Metasul) and ceramic-on-ceramic (Cerasul) bearings', 'Metasul vs Cerasul bearings']","['Harris Hip Score', 'Fractures of Cerasul insert', 'Survival free of any revision', 'Survival free of aseptic loosening']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}]",125.0,0.0378618,"Survival free of aseptic loosening was higher for Cerasul (100%), than for Metasul (94% [CI 88-99.9]) (p = 0.04).","[{'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Andeol', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Viste', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France. anthony.viste@chu-lyon.fr.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Desmarchelier', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Lerat', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}, {'ForeName': 'Michel-Henri', 'Initials': 'MH', 'LastName': 'Fessy', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Lyon Sud, Service de Chirurgie Orthopédique et Traumatologique, 165 Chemin du Grand Revoyet, 69495, Pierre Bénite Cedex, France.'}]",International orthopaedics,['10.1007/s00264-020-04855-9']
1378,33086438,Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy.,"BACKGROUND


The ongoing UNIFI long-term extension evaluates subcutaneous ustekinumab for moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220.
AIMS


To assess efficacy (through week 92) and safety (through week 96) during the long-term extension METHODS: Overall, 399 responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long-term extension (115 received subcutaneous placebo, 141 received ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). Placebo treatment was discontinued at unblinding after week 44. Partial Mayo scores were collected every 12 weeks and at each dosing visit after unblinding. Safety was evaluated throughout.
RESULTS


Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively. Among randomised patients treated in the long-term extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, attained symptomatic remission at week 92; >95% of patients in symptomatic remission at week 92 were corticosteroid-free. Both ustekinumab groups maintained efficacy through week 92. From weeks 44 to 96, adverse events (AEs) per hundred patient-years (PY) of follow-up for combined ustekinumab vs placebo were: 255.68 vs 267.93; serious AEs, 9.34 vs 12.69; malignancies (including non-melanoma skin cancers), 0.93 vs 1.49; and serious infections, 2.33 vs 2.99. One patient with multiple comorbidities who received one ustekinumab dose after dose adjusting from placebo experienced a fatal cardiac arrest.
CONCLUSIONS


The efficacy of ustekinumab in patients with UC was sustained through 92 weeks. No new safety signals were observed (ClinicalTrials.gov number, NCT02407236).",2020,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","['moderate-to-severe ulcerative colitis (UC) from weeks 44 through 220', 'patients with UC']","['subcutaneous placebo', 'Ustekinumab', 'ustekinumab', 'placebo', 'ustekinumab 90\xa0mg every 12\xa0weeks [q12w], and 143 received ustekinumab 90\xa0mg q8w', 'Placebo']","['Safety', 'serious infections', 'Partial Mayo scores', 'symptomatic remission rates', 'fatal cardiac arrest', 'new safety signals', 'symptomatic remission']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.361164,"Among all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively.","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Calgary, AB, Canada.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Milan, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'La Jolla, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Tikhonov', 'Affiliation': 'Spring House, PA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Targan', 'Affiliation': 'Los Angeles, CA, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Miami, FL, USA.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Scherl', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Concord, NSW, Australia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rowbotham', 'Affiliation': 'Auckland, New Zealand.'}, {'ForeName': 'Ramesh P', 'Initials': 'RP', 'LastName': 'Arasaradnam', 'Affiliation': 'Coventry, UK.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'New York, NY, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Spring House, PA, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16119']
1379,33091360,"Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.","BACKGROUND


In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.
METHODS


In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing.
FINDINGS


Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.
INTERPRETATION


There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.
FUNDING


Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.",2020,"The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83).","['patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention', 'Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients', 'all-comer population undergoing percutaneous coronary intervention']","['DCB versus DES', 'drug-coated balloons versus drug-eluting stents', 'DES', 'DCB or second-generation DES', 'DCB', 'DCBs']","['major bleeding', 'rate of major adverse cardiac events', 'single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate', 'TVR', 'Rates of all-cause death', 'non-fatal myocardial infarction', 'Rates of probable or definite stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.203546,"The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83).","[{'ForeName': 'Raban V', 'Initials': 'RV', 'LastName': 'Jeger', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland. Electronic address: raban.jeger@usb.ch.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Knappschaftskrankenhaus, Klinikum Westfalen, Dortmund, Germany.'}, {'ForeName': 'Marc-Alexander', 'Initials': 'MA', 'LastName': 'Ohlow', 'Affiliation': 'Central Clinic, Bad Berka, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Mangner', 'Affiliation': 'Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Möbius-Winkler', 'Affiliation': 'University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weilenmann', 'Affiliation': 'Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Klinikum Friedrichshafen, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stachel', 'Affiliation': 'Heart Center Leipzig, University Hospital, Leipzig, Germany.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Markovic', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leibundgut', 'Affiliation': 'Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rickenbacher', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Osswald', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cattaneo', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gilgen', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kaiser', 'Affiliation': 'University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scheller', 'Affiliation': 'University Hospital Saarland, Homburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32173-5']
1380,33091438,The placebo effect in breath holding: a preliminary behavioral investigation.,"PURPOSE


This study seeks to evaluate effects of expectations and conditioning on dry breath holding.
METHODS


Sixty healthy volunteers were subdivided into 3 groups and were tested across 4 breath holding trials. Participants of the Control group (C) did not undergo any manipulation. Participants of the placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2) along with opposite information that this would enhance or worsen their breath holding time, respectively. Opposite conditioning paradigms based on false visual feedback were employed to reinforce participants' positive (placebo) and negative (nocebo) beliefs.
RESULTS


The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001). Additionally, in the last trial the P group showed a greater decrease in peripheral oxygen saturation (SpO2) as compared to the C group (p = 0.04) and the N group (p = 0.001). Heart rate (HR) was accelerated in the N group during breath holding (in comparison to the P group [p = 0.04] and C group [p = 0.04]).
CONCLUSIONS


Psychological components can affect behavioral and physiological parameters in breath holding. This study may inform future research about the role of placebo and nocebo effects for conditions in which critical functions are at play.",2020,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,['Sixty healthy volunteers'],"['placebo', 'placebo (P) and nocebo (N) groups were told that they would inhale O2 (actually sham O2) or CO2 (actually sham CO2']","['breath holding time', 'longest breath holding time', 'peripheral oxygen saturation (SpO2', 'Heart rate (HR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.145215,The P group showed the greater increase in breath holding time from baseline to the last trial (p = 0.0001) and the longest breath holding time in the last trial compared to the C group (p = 0.02) and the N group (p = 0.0001).,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Piedimonte', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Barbiani', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy; Medicine & Physiology of Hypoxia, Plateau Rosa Laboratories, Breuil-Cervinia, Italy, Zermatt, Switzerland.'}, {'ForeName': 'Denisa Adina', 'Initials': 'DA', 'LastName': 'Zamfira', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Carlino', 'Affiliation': 'Department of Neuroscience ""Rita Levi Montalcini"", University of Turin, Italy. Electronic address: elisa.carlino@unito.it.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135434']
1381,33092401,Efficacy of MAVIG X-Ray Protective Drapes in Reducing Operator Radiation Dose in the Cardiac Catheterization Laboratory: A Randomized Controlled Trial.,"BACKGROUND


Interventional cardiologists are occupationally exposed to high doses of ionizing radiation. The MAVIG X-ray protective drape (MXPD) is a commercially available light weight, lead-free shield placed over the pelvic area of patients to minimize operator radiation dose. The aim of this study was to examine the efficacy of the MXPD during routine cardiac catheterization, including percutaneous coronary interventions.
METHODS


We performed a prospective, randomized controlled study comparing operator radiation dose during cardiac catheterization and percutaneous coronary intervention (n=632) with or without pelvic MXPD. We measured operator radiation dose at 4 sites: left eye, chest, left ring finger, and right ring finger. The primary outcomes were the difference in first operator radiation dose (µSv) and relative dose of the first operator (radiation dose normalized for dose area product) at the level of the chest in the 2 groups.
RESULTS


The use of the MXPD was associated with a 50% reduction in operator radiation dose (median dose 30.5 [interquartile range, 23.0-39.7] µSv in no drape group versus 15.3 [interquartile range, 11.1-20.0] µSv in the drape group;  P <0.001) and a 57% reduction in relative operator dose ( P <0.001). The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4] µSv versus 41.9 [32.6-70.6] µSv in the drape group;  P <0.001).
CONCLUSIONS


The pelvic MXPD significantly reduces first operator radiation dose during routine cardiac catheterization and percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04285944.",2020,The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4],['Cardiac Catheterization Laboratory'],"['MXPD', 'MAVIG X-Ray Protective Drapes', 'MAVIG X-ray protective drape (MXPD', 'operator radiation dose during cardiac catheterization and percutaneous coronary intervention (n=632) with or without pelvic MXPD']",['difference in first operator radiation dose (µSv) and relative dose of the first operator (radiation dose normalized for dose area product) at the level of the chest'],"[{'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",632.0,0.0679716,The largest absolute reduction in dose was observed at the left finger (median left finger dose for the no drape group was 104.9 [75.7-137.4],"[{'ForeName': 'Keir', 'Initials': 'K', 'LastName': 'McCutcheon', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Vanhaverbeke', 'Affiliation': 'Belgian Nuclear Research Centre, Research in Dosimetric Applications, Mol, Belgium (J.D., W.S.).'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Pauwels', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Dabin', 'Affiliation': 'Belgian Nuclear Research Centre, Research in Dosimetric Applications, Mol, Belgium (J.D., W.S.).'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schoonjans', 'Affiliation': 'Belgian Nuclear Research Centre, Research in Dosimetric Applications, Mol, Belgium (J.D., W.S.).'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Adriaenssens', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubois', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Desmet', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospitals Leuven, Belgium (K.M., M.V., R.P., J.B., T.A., C.D., P.S., W.D.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009627']
1382,33092618,"Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease.","Chronic obstructive pulmonary disease (COPD) is expected to be the 3 rd  leading cause of death worldwide by 2020. Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death. Recent studies suggested that NIV at home can reduce readmissions, but in a small proportion of patients, and with a high level of expertise. Other studies, however, do not show any benefit of home NIV. This could be related to the fact that respiratory failure in patients with stable COPD and their response to mechanical ventilation are influenced by several pathophysiological factors which frequently coexist in the same patient to varying degrees. These pathophysiological factors might influence the success of home NIV in stable COPD, thus long-term NIV specifically adapted to a patient's ""phenotype"" is likely to improve prognosis, reduce readmission to hospital, and prevent death. In view of this conundrum, Rescue2-monitor (R2M), an open-label, prospective randomized, controlled study performed in patients with hypercapnic COPD post-AHRF, will investigate the impact of the quality of nocturnal NIV on the readmission-free survival. The primary objective is to show that any of 3 home NIV strategies (""rescue,"" ""non-targeted,"" and ""targeted"") will improve readmission-free survival in comparison to no-home NIV. The ""targeted"" group of patients will receive a treatment with personalized (targeted) ventilation settings and extensive monitoring. Furthermore, the influence of comorbidities typical for COPD patients, such as cardiac insufficiency, OSA, or associated asthma, on ventilation outcomes will be taken into consideration and reasons for non-inclusion of patients will be recorded in order to evaluate the percentage of ventilated COPD patients that are screening failures. ClinicalTrials.gov NCT03890224 . Registered on March 26, 2019.",2020,"Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death.","['COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor', 'patients with hypercapnic chronic obstructive pulmonary disease', 'patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF', 'Chronic obstructive pulmonary disease (COPD', 'patients with stable COPD', 'patients with hypercapnic COPD post-AHRF']","['hospital- versus home-based acute non-invasive ventilation', 'personalized (targeted) ventilation settings and extensive monitoring', '3 home NIV strategies (""rescue,"" ""non-targeted,"" and ""targeted']",['survival'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C4040419', 'cui_str': 'Acute hypercapnic respiratory failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.057771,"Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04672-w']
1383,33094208,Minimizing Glucose Excursions (GEM) With Continuous Glucose Monitoring in Type 2 Diabetes: A Randomized Clinical Trial.,"This study aimed to compare conventional medication management of type 2 diabetes (T2D) to medication management in conjunction with a lifestyle intervention using continuous glucose monitoring to minimize glucose excursions. Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A 1c  (HbA 1c ) ≥ 7.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin, were randomly assigned in a 1:2 ratio to routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEM CGM ). Assessments at baseline and 5 months included a physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires. For the week following assessments, participants wore a blinded activity monitor and completed 3 days of 24-hour dietary recall. A subgroup also wore a blinded CGM. GEM CGM  participants significantly improved HbA 1c  (from 8.9% to 7.6% [74-60 mmol/mol] compared with 8.8% to 8.7% [73-72 mmol/mol] for RC ( P  = .03). Additionally, GEM CGM  reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia. Confirming our prior research, GEM CGM  appears to be a safe, effective lifestyle intervention option for adults with suboptimally controlled T2D who do not take insulin.",2020,"Additionally, GEM CGM  reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia.","['adults with suboptimally controlled T2D who do not take insulin', 'Type 2 Diabetes', 'Thirty adults (63% female; mean age, 53.3 years) who were diagnosed with T2D for less than 11 years (mean, 5.6 years), had glycated A 1c  (HbA 1c )\u2005≥\u20057.0% (51 mmol/mol) (mean 8.8%, [73 mmol/mol]), and were not using insulin']","['GEM CGM', 'routine care (RC) or 4 group sessions of glycemic excursion minimization plus real-time CGM (GEM CGM ']","['diabetes knowledge', 'diabetes distress', 'physical exam, metabolic and lipid panels, a review of diabetes medications, and psychological questionnaires', 'HbA 1c', 'need for diabetes medication', 'dietary fat, lipids, or hypoglycemia', 'reduced carbohydrate consumption', 'quality of life', 'Minimizing Glucose Excursions (GEM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0445107', 'cui_str': 'Not used'}]","[{'cui': 'C0445501', 'cui_str': 'Gem'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0445501', 'cui_str': 'Gem'}]",30.0,0.0359699,"Additionally, GEM CGM  reduced the need for diabetes medication ( P  = .01), reduced carbohydrate consumption ( P  = .009), and improved diabetes knowledge ( P  = .001), quality of life ( P  = .01) and diabetes distress ( P  = .02), and trended to more empowerment ( P  = .05) without increasing dietary fat, lipids, or hypoglycemia.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Cox', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Banton', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Moncrief', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conaway', 'Affiliation': 'University of Virginia School of Medicine, Public Health Sciences, Charlottesville, VA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Diamond', 'Affiliation': 'University of Virginia School of Medicine, Center for Behavioral Medicine Research, Charlottesville, Virginia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'McCall', 'Affiliation': 'University of Virginia School of Medicine, Endocrinology and Metabolism, Charlottesville, VA.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa118']
1384,33095180,Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice.,"In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.",2020,An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized.,"['With Tic Disorders', 'children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial', 'Children and Young People']","['Therapist-Supported Online Interventions', 'internet-based cognitive behavioral therapy (iCBT', '4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention']",[],"[{'cui': 'C0040188', 'cui_str': 'Tic disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.052188,An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized.,"[{'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Chamberlain', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Hall', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Andrén', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'E Bethan', 'Initials': 'EB', 'LastName': 'Davies', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kilgariff', 'Affiliation': 'Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kouzoupi', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Murphy', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}]",JMIR mental health,['10.2196/19600']
1385,33095184,Mobile Social Network-Based Smoking Cessation Intervention for Chinese Male Smokers: Pilot Randomized Controlled Trial.,"BACKGROUND


Around 2 million Chinese people, mostly men, die annually from tobacco-related diseases; yet, fewer than 8% of Chinese smokers ever receive any smoking cessation support.
OBJECTIVE


This study aimed to test the preliminary effectiveness and feasibility for a mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program) among Chinese male smokers.
METHODS


Chinese male smokers aged 25-44 years were recruited online from WeChat, the most widely used social media platform in China. Individuals using other smoking cessation interventions or who lacked capacity to provide online informed consent were excluded. Participants were randomly assigned (1:1) to intervention or control groups. Neither participants nor researchers were masked to assignment. The trial was fully online. All data were collected via WeChat. The intervention group received access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines. Specific intervention functions used in the program include: planning to help users make quitting plans, calculator to record quitting benefits, calendar to record progress, gamification to facilitate quitting, information about smoking harms, motivational messages to help users overcome urges, standardized tests for users to assess their levels of nicotine dependence and lung health, as well as a social platform to encourage social support between users. The control group had access to a static WeChat page of contacts for standard smoking cessation care. Both groups received incentive credit payments for participating. The primary outcome was 30-day biochemically verified smoking abstinence at 6 weeks after randomization, with missing data treated as not quitting. Secondary outcomes were other smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program.
RESULTS


The program recorded 5736 visitors over a 13-day recruitment period. We recruited 80 participants who were randomly allocated to two arms (n=40 per arm). At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat. Biochemically verified smoking abstinence at 6 weeks was determined for 10 of 40 (25%) intervention participants and 2 of 40 (5%) control participants (RR=5, 95% CI 1.2-21.4, P=.03). In the intervention group, the calculator function, motivational messages, and health tests were underused (less than once per week per users). Participants rated their satisfaction with the intervention program as 4.56 out of 5.00.
CONCLUSIONS


Our program is a novel, accessible, and acceptable smoking cessation intervention for Chinese male smokers. A future trial with a greater sample size and longer follow-up will identify if it is as effective as these preliminary data suggest.
TRIAL REGISTRATION


ANZCTR registry, ACTRN12618001089224; https://tinyurl.com/y536n7sx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-18071.",2020,"At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat.","['Chinese male smokers', '80 participants who were randomly allocated to two arms (n=40 per arm', 'Chinese male smokers aged 25-44 years', 'Chinese Male Smokers']","['smoking cessation interventions', 'Mobile Social Network-Based Smoking Cessation Intervention', 'incentive credit payments', 'access to the full-version SCAMPI program, a Chinese-language smoking cessation program based on the Behaviour Change Wheel framework and relevant cessation guidelines', 'mobile social network (WeChat)-based smoking cessation intervention (SCAMPI program']","['smoking abstinence', '30-day biochemically verified smoking abstinence', 'calculator function, motivational messages, and health tests', 'smoking status measures, reduction of cigarette consumption, study feasibility (recruitment and retention rate), and acceptability of and satisfaction with the program']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0453056', 'cui_str': 'Scampi'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",80.0,0.0814973,"At 6 weeks, 36 of 40 (90%) intervention participants and 35 of 40 (88%) control participants provided complete self-reported data on their daily smoking status via WeChat.","[{'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Whittaker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tingzhong', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Centre for Tobacco Control Research, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/17522']
1386,33096291,Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction: A randomized controlled trial.,"BACKGROUND


Pre-extinction fear memory reactivation (PE-FMR) and deepened extinction (DE) enhance long-term extinction of shock-conditioned fear, and may also enhance long-term extinction of naturally acquired fear. Preliminary data suggest that PE-FMR may additionally boost the speed of fear reduction during exposure therapy.
DESIGN


Randomized controlled trial, factorial design.
METHODS


Participants with elevated fears of either spiders or snakes were randomized to (1) exposure therapy alone (n = 41), (2) exposure therapy + PE-FMR (n = 42), (3) exposure therapy + DE (n = 41), or (4) exposure therapy + PE-FMR + DE (n = 42). Participants were assessed at baseline, post-treatment, and one-week follow-up on subjective and behavioral indices of phobia. Because treatment length was tailored to speed of fear reduction, survival analyses were used to examine the speed of fear reduction during treatment.
RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
CONCLUSIONS


Data suggest that PE-FMR is a promising strategy for reducing the overall duration of exposure-based therapies.
CLINICAL TRIAL REGISTRATION


(clinicaltrials.gov)NCT02160470.",2020,"RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
",['Participants with elevated fears of either spiders or snakes'],"['Augmenting exposure therapy with pre-extinction fear memory reactivation and deepened extinction', 'PE-FMR', 'exposure therapy alone (n\xa0=\xa041), (2) exposure therapy\xa0+\xa0PE-FMR (n\xa0=\xa042), (3) exposure therapy\xa0+\xa0DE (n\xa0=\xa041), or (4) exposure therapy\xa0+\xa0PE-FMR\xa0+\xa0DE']","['clinical outcomes', 'rapid fear reduction']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",42.0,0.0830397,"RESULTS


DE did not improve clinical outcomes at post-treatment or follow-up, whereas PE-FMR produced more rapid fear reduction and was able to achive equivalent outcomes even when the duration of exposure therapy (tailored to speed of fear reduction) was shortened by an average of 21%.
","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA; Department of Psychology, University of Nevada, Reno. 1664 N. Virginia Street, Mail Stop 0298. Reno, NV, USA. Electronic address: cynthialancaster@unr.edu.'}, {'ForeName': 'Marie-H', 'Initials': 'MH', 'LastName': 'Monfils', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Telch', 'Affiliation': 'Department of Psychology, University of Texas. 108 E. Dean Keeton Stop A8000. Austin, TX, USA. Electronic address: telch@austin.utexas.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103730']
1387,33096332,"The role of expressive suppression and cognitive reappraisal in cognitive behavioral therapy for social anxiety disorder: A study of self-report, subjective, and electrocortical measures.","BACKGROUND


Contemporary models of cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) emphasize emotion dysregulation as a core impairment whose reduction may play a causal role in psychotherapy. The current study examined changes in use of emotion regulation strategies as possible mechanisms of change in CBT for SAD. Specifically, we examined changes in expressive suppression and cognitive reappraisal during CBT and whether these changes predict treatment outcome.
METHODS


Patients (n = 34; 13 females; Mean age = 28.36 (6.97)) were allocated to 16-20 sessions of CBT. An electrocortical measure of emotion regulation and a clinician-rated measure of SAD were administered monthly. Self-report measures of emotion regulation and social anxiety were administered weekly. Multilevel models were used to examine changes in emotion regulation during treatment and cross-lagged associations between emotion regulation and anxiety.
RESULTS


CBT led to decreased suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures (ps < .05). At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli. Gains were maintained at 3-months follow-up. Decreases in suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety but not the other way around (ps < .05). Lower anxiety predicted greater subsequent increases in reappraisal self-efficacy.
LIMITATIONS


The lack of a control group precludes conclusions regarding mechanisms specificity.
CONCLUSIONS


Decreased frequency of suppression is a potential mechanism of change in CBT for SAD.",2020,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","['Patients (n\xa0', 'social anxiety disorder', '34; 13 females; Mean age\xa0=\xa028.36 (6.97']","['cognitive behavioral therapy (CBT', 'expressive suppression and cognitive reappraisal in cognitive behavioral therapy']","['emotion regulation', 'emotion regulation and social anxiety', 'suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety', 'suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures', 'expressive suppression and cognitive reappraisal', 'reappraisal self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0112977,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: yogev.kivity@biu.ac.il.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.021']
1388,33075711,The effect of dry needling on gastrocnemius muscle stiffness and strength in participants with latent trigger points.,"Abnormal muscle stiffness is a potential complication after injury and identifying interventions that modify muscle stiffness may be useful to promote recovery. The purpose of this study was to identify the short-term effects of dry needling (DN) on resting and contracted gastrocnemius muscle stiffness and strength of the triceps surae in individuals with latent myofascial trigger points (MTrPs). In this randomized controlled trial, 52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two sham needling sessions. Resting and contracted muscle stiffness were assessed both at the treatment site and a standardized central site in the medial gastrocnemius head immediately post-treatment and one week after the last session. There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29). Post-needling between group comparison indicated that the DN group had significantly lower resting muscle stiffness at the site of the MTrP than the sham group after adjusting for baseline differences. There were no significant between group differences in contracted muscle stiffness or muscle strength. Identifying strategies that can reduce aberrant muscle stiffness may help to guide management of individuals with neuromuscular pain-related conditions. Level of evidence: Therapy, level 2.",2020,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","['participants with latent trigger points', '52 individuals received two DN treatment sessions to latent MTrPs and 50 individuals received two', 'individuals with latent myofascial trigger points (MTrPs', 'individuals with neuromuscular pain-related conditions']","['sham needling sessions', 'dry needling', 'dry needling (DN']","['resting muscle stiffness', 'contracted muscle stiffness or muscle strength', 'gastrocnemius muscle stiffness and strength', 'Level of evidence', 'Resting and contracted muscle stiffness', 'time interactions for resting muscle stiffness']","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1405031', 'cui_str': 'Neuromuscular pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",52.0,0.067405,"There were significant group by time interactions for resting muscle stiffness at the site of the MTrP (p = .03), but not at the central site (p = .29).","[{'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Albin', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Koppenhaver', 'Affiliation': 'Baylor University Doctoral Program in Physical Therapy, Waco, TX, United States.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'MacDonald', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Capoccia', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ngo', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Phippen', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pineda', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wendlandt', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Hoffman', 'Affiliation': 'Regis University, School of Physical Therapy, Denver, CO, United States.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102479']
1389,33084584,Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study.,"BACKGROUND


Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted.
OBJECTIVE


The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health-based physical activity intervention for pregnant women with diabetes.
METHODS


Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program. Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician. They were given a Fitbit and shown how to use the Fitbit app, including entering personalized step goals, and were encouraged to build up to 10,000 daily steps. Daily steps were recorded for 12 weeks, until they were 36 weeks' gestation, or until 1 week before they gave birth, whichever came first. Feasibility was measured by recruitment, retention, and adherence, and acceptability was measured using consumer satisfaction questionnaires and follow-up interviews. Potential efficacy was explored by examining changes in daily steps over time.
RESULTS


The participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71%). Of the 17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention. Adherence in wearing the Fitbit was relatively high, with a median wear adherence of 90% of days. The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall. Mean daily steps increased from baseline (mean 6122, SD 2439) to week 3 (mean 6269, SD 2166) and then decreased through week 12 (mean 4191, SD 2228).
CONCLUSIONS


High acceptability, retention, and adherence suggest that this may be a promising approach to delivering a simple, low-burden intervention in a clinical setting to a high-risk, underserved population. A randomized controlled trial is needed to determine whether this approach is effective in slowing the reduction in activity typically seen throughout pregnancy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03302377; https://clinicaltrials.gov/ct2/show/NCT03302377.",2020,"The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall.","['17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention', 'pregnant women with diabetes', 'Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program', 'Pregnant Women With Diabetes', 'participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71', 'Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician']","['Counseling- and mHealth-Based Physical Activity Intervention', 'counseling- and mobile health-based physical activity intervention']","['Feasibility and Acceptability', 'recruitment, retention, and adherence, and acceptability', 'Potential efficacy', 'Mean daily steps', 'feasibility and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.063377,"The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall.","[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Micucci', 'Affiliation': 'Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Ramos', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, San Diego, CA, United States.'}]",JMIR mHealth and uHealth,['10.2196/18915']
1390,33080411,The effect of dietary nitrate on exercise capacity in chronic kidney disease: a randomized controlled pilot study.,"BACKGROUND


Chronic Kidney Disease (CKD) patients exhibit a reduced exercise capacity that impacts quality of life. Dietary nitrate supplementation has been shown to have favorable effects on exercise capacity in disease populations by reducing the oxygen cost of exercise. This study investigated whether dietary nitrates would acutely improve exercise capacity in CKD patients.
METHODS AND RESULTS


In this randomized, double-blinded crossover study, 12 Stage 3-4 CKD patients (Mean ± SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6 ml/min/1.73 m 2 ) received an acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA). Skeletal muscle mitochondrial oxidative function was assessed using near-infrared spectroscopy. Cardiopulmonary exercise testing was performed on a cycle ergometer, with intensity increased by 25 W every 3 min until volitional fatigue. Plasma nitric oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound NO) were determined by gas-phase chemiluminescence. Plasma NOm values were significantly increased following BRJ (BRJ vs. PLA: 1074.4 ± 120.4 μM vs. 28.4 ± 6.6 μM, p < 0.001). Total work performed (44.4 ± 10.6 vs 39.6 ± 9.9 kJ, p = 0.03) and total exercise time (674 ± 85 vs 627 ± 86s, p = 0.04) were significantly greater following BRJ. Oxygen consumption at the ventilatory threshold was also improved by BRJ (0.90 ± 0.08 vs. 0.74 ± 0.06 L/min, p = 0.04). These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p = 0.52) and VO 2peak  (p = 0.35).
CONCLUSIONS


Our findings demonstrate that inorganic nitrate can acutely improve exercise capacity in CKD patients. The effects of chronic nitrate supplementation on CKD related exercise intolerance should be investigated in future studies.",2020,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
","['12 Stage 3-4 CKD patients (Mean±SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6ml/min/1.73m 2 ) received an', 'Chronic Kidney Disease (CKD) patients', 'CKD patients', 'chronic kidney disease']","['chronic nitrate supplementation', 'dietary nitrate', 'acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA', 'BRJ (BRJ vs. PLA', 'dietary nitrates', 'Dietary nitrate supplementation', 'inorganic nitrate']","['total exercise time', 'Oxygen consumption', 'skeletal muscle mitochondrial oxidative capacity', 'Plasma NOm values', 'Plasma Nitric Oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound', 'exercise capacity', 'Skeletal muscle mitochondrial oxidative function']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0141313', 'cui_str': 'S-Nitrosothiol'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.142506,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak  (p=0.35).
","[{'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology, West Chester University, West Chester, PA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kirkman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Stock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Bryce J', 'Initials': 'BJ', 'LastName': 'Muth', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; School of Health Sciences, Stockton University, Stockton, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Paschalis-Thomas', 'Initials': 'PT', 'LastName': 'Doulias', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Ischiropoulos', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. Electronic address: dge@udel.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2020.10.002']
1391,33080415,Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Α double-blinded randomized controlled trial.,"BACKGROUND


Spinal anesthesia for cesarean section can be complicated by hypotension, with untoward effects for both the mother and fetus. Frequently used phenylephrine can lead to baroreceptor-mediated reflex bradycardia. The aim of the present study was to compare a fixed-rate prophylactic norepinephrine infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia.
MATERIALS AND METHODS


Eighty-two parturients were randomized to either norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution. The primary endpoint was the incidence of maternal bradycardia. Maternal hemodynamics at specific timepoints, the incidence of hypotension or hypertension, the requirement for ephedrine or atropine bolus administration as well as the acid-base status and Apgar score of the neonate were recorded.
RESULTS


The incidence of bradycardia as well as the requirement for atropine administration was lower in the norepinephrine group (4.8% vs. 31.7%, p = 0.004 and 2.4% vs. 24.3%, p = 0.01, respectively). Fetal pH, and fetal blood glucose concentration were higher in the norepinephrine group (p = 0.027 and 0.019, respectively). No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
CONCLUSIONS


A fixed-rate infusion of norepinephrine is as effective in the management of hypotension during regional anesthesia for cesarean section as a fixed-rate infusion of phenylephrine, with the avoidance of phenylephrine-induced bradycardia. The more favourable neonatal acid-base profile of noradrenaline might be due to better maintenance of placental blood flow in the noradrenaline group due to its beta action, while the higher fetal glucose concentration in the same group might result from a catecholamine-stimulated glucose metabolism increase and a β-receptor mediated insulin decrease.",2020,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","['Eighty-two parturients', 'hypotension during elective cesarean section with a']","['norepinephrine', 'fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine', 'norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution', 'phenylephrine', 'phenylephrine infusion']","['Maternal hemodynamics', 'incidence of hypotension or hypertension', 'incidence of bradycardia', 'occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores', 'fetal glucose concentration', 'Fetal pH, and fetal blood glucose concentration', 'incidence of maternal bradycardia', 'placental blood flow']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",82.0,0.245385,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","[{'ForeName': 'Kassiani', 'Initials': 'K', 'LastName': 'Theodoraki', 'Affiliation': '1st Department of Anesthesiology, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece. Electronic address: ktheodoraki@hotmail.com.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Hadzilia', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Valsamidis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.10.006']
1392,33087330,Expanded Low Allele Frequency  RAS  and  BRAF  V600E Testing in Metastatic Colorectal Cancer as Predictive Biomarkers for Cetuximab in the Randomized CO.17 Trial.,"PURPOSE


Expanded  RAS/BRAF  mutations have not been assessed as predictive for single-agent cetuximab in metastatic colorectal cancer (mCRC), and low mutant allele frequency (MAF) mutations are of unclear significance. We aimed to establish cetuximab efficacy in optimally selected patients using highly sensitive beads, emulsion, amplification, and magnetics (BEAMing) analysis, capable of detecting alterations below standard clinical assays.
PATIENTS AND METHODS


CO.17 trial compared cetuximab versus best supportive care (BSC) in  RAS/BRAF -unselected mCRC. We performed  RAS/BRAF  analysis on microdissected tissue of 242 patients in CO.17 trial using BEAMing for  KRAS/NRAS  (codons 12/13/59/61/117/146) and  BRAF  V600E. Patients without BEAMing but with previous Sanger sequencing-detected mutations were included.
RESULTS


KRAS, NRAS , and  BRAF  mutations were present in 53%, 4%, and 3% of tumors, respectively. Cetuximab improved overall survival [OS; HR, 0.51; 95% confidence interval (CI), 0.32-0.81;  P  = 0.004] and progression-free survival (PFS; HR, 0.25; 95% CI, 0.15-0.41;  P  < 0.0001) compared with BSC in  RAS/BRAF  wild-type patients. Cetuximab did not improve OS/PFS for  KRAS-, NRAS- , or  BRAF- mutated tumors, and tests of interaction confirmed expanded  KRAS  ( P  = 0.0002) and  NRAS  ( P  = 0.006) as predictive, while  BRAF  mutations were not ( P  = 0.089). BEAMing identified 14% more tumors as  RAS  mutant than Sanger sequencing, and cetuximab lacked activity in these patients. Mutations at MAF < 5% were noted in 6 of 242 patients (2%). One patient with a  KRAS  A59T mutation (MAF = 2%) responded to cetuximab. More  NRAS  than  KRAS  mutations were low MAF (OR, 20.50; 95% CI, 3.88-96.85;  P  = 0.0038).
CONCLUSIONS


We establish single-agent cetuximab efficacy in optimally selected patients and show that subclonal  RAS/BRAF  alterations are uncommon and remain of indeterminate significance.",2020,"Cetuximab improved overall survival (OS) (HR 0.51, 95% CI 0.32-0.81, P=0.004) and progression free survival (PFS) (HR 0.25, 95% CI 0.15-0.41, P<0.0001) compared to BSC in RAS/BRAF wild type patients.",['metastatic colorectal cancer (mCRC) and'],"['Cetuximab', 'cetuximab versus best supportive care (BSC', 'cetuximab']","['overall survival (OS', 'KRAS, NRAS, and BRAF mutations', 'progression free survival (PFS', 'NRAS', 'OS/PFS for KRAS, NRAS, or BRAF mutated tumors and tests of interaction confirmed expanded KRAS']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}]",242.0,0.136332,"Cetuximab improved overall survival (OS) (HR 0.51, 95% CI 0.32-0.81, P=0.004) and progression free survival (PFS) (HR 0.25, 95% CI 0.15-0.41, P<0.0001) compared to BSC in RAS/BRAF wild type patients.","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Loree', 'Affiliation': 'BC Cancer, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dowers', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Jonker', 'Affiliation': 'The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edelstein', 'Affiliation': 'Sysmex-Inostics, Baltimore, Maryland.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Quinn', 'Affiliation': 'Sysmex-Inostics, Baltimore, Maryland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Holtrup', 'Affiliation': 'Sysmex-Inostics, Baltimore, Maryland.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zalcberg', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Malcolm J', 'Initials': 'MJ', 'LastName': 'Moore', 'Affiliation': 'BC Cancer, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Waring', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Hagen F', 'Initials': 'HF', 'LastName': 'Kennecke', 'Affiliation': 'Virginia Mason Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'City of Hope, Los Angeles, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Kopetz', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas. skopetz@mdanderson.org.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2710']
1393,33074695,Children's evaluations of individually and structurally based inequalities: The role of status.,"Social inequalities limit important opportunities and resources for members of marginalized and disadvantaged groups. Understanding the origins of how children construct their understanding of social inequalities in the context of their everyday peer interactions has the potential to yield novel insights into when-and how-individuals respond to different types of social inequalities. The present study examined whether children ( N  = 176; 3- to 8-years-old; 52% female, 48% male; 70% European American, 16% African American, 10% Latinx, and 4% Asian American; middle-income backgrounds) differentiate between structurally based inequalities (e.g., based on gender) and individually based inequalities (e.g., based on merit). Children were randomly assigned to a group that received more (advantaged) or fewer (disadvantaged) resources than another group due to either their groups' meritorious performance on a task or the gender biases of the peer in charge of allocating resources. Overall, children evaluated structurally based inequalities to be more unfair and worthy of rectification than individually based inequalities, and disadvantaged children were more likely to view inequalities to be wrong and act to rectify them compared to advantaged children. With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair. Yet, the majority of children allocated equally in response to both types of inequality. The findings generated novel evidence regarding how children evaluate and respond to individually and structurally based inequalities, and how children's own status within the inequality informs these responses. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair.","['members of marginalized and disadvantaged groups', 'children ( N  = 176; 3- to 8-years-old; 52% female, 48% male; 70% European American, 16% African American, 10% Latinx, and 4% Asian American; middle-income backgrounds) differentiate between structurally based inequalities (e.g., based on gender) and individually based inequalities (e.g., based on merit']","[""more (advantaged) or fewer (disadvantaged) resources than another group due to either their groups' meritorious performance on a task or the gender biases of the peer in charge of allocating resources""]",[],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205906', 'cui_str': 'Gender Bias'}]",[],,0.0184298,"With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rizzo', 'Affiliation': 'New York University.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Killen', 'Affiliation': 'University of Maryland.'}]",Developmental psychology,['10.1037/dev0001118']
1394,33074709,Effect of Endoplasmic Reticulum Stress on Endothelial Ischemia-Reperfusion Injury in Humans.,"Endoplasmic reticulum stress contributes to ischemia-reperfusion (I/R) injury in rodent and cell models. However, the contribution of endoplasmic reticulum stress in the pathogenesis of endothelial I/R injury in humans is unknown. We tested the hypothesis that compared with placebo, inhibition of endoplasmic reticulum stress via ingestion of tauroursodeoxycholic acid would prevent the attenuation of endothelium-dependent vasodilation following I/R injury. Twelve young adults (six women) were studied following ingestion of a placebo or 1,500 mg tauroursodeoxycholic acid (TUDCA). Endothelium-dependent vasodilation was assessed via brachial artery flow-mediated dilation (duplex ultrasonography) before and after I/R injury, which was induced by 20 min of arm ischemia followed by 20 min of reperfusion. Endothelium-independent vasodilation (glyceryl trinitrate-mediated vasodilation) was also assessed after I/R injury. Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1  and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1  (both P < 0.01). Ischemia-reperfusion injury attenuated endothelium-dependent vasodilation, an effect that did not differ between placebo (pre-I/R, 5.0 ± 2.1% vs. post-I/R 3.5 ± 2.2%) and TUDCA (pre-I/R, 5.6 ± 2.1% vs. post-I/R 3.9 ± 2.1%; P = 0.8) conditions. Similarly, endothelium-independent vasodilation did not differ between conditions (placebo, 19.6 ± 4.8% vs. TUDCA, 19.7 ± 6.1%; P = 0.9). Taken together, endoplasmic reticulum stress does not appear to contribute to endothelial I/R injury in healthy young adults.",2020,"Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1  and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1  (both P < 0.01).","['healthy young adults', 'Twelve young adults (six women', 'Humans']","['tauroursodeoxycholic acid', 'placebo or 1,500 mg tauroursodeoxycholic acid (TUDCA', 'placebo', 'ursodeoxycholic acid', 'Endoplasmic Reticulum Stress', 'placebo, TUDCA ingestion']","['circulating plasma concentrations', 'Endothelial Ischemia-Reperfusion Injury', 'endothelium-independent vasodilation', 'Endothelium-dependent vasodilation was assessed via brachial artery flow-mediated dilation (duplex ultrasonography', 'Endothelium-independent vasodilation (glyceryl trinitrate-mediated vasodilation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0075857', 'cui_str': 'tauroursodeoxycholic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]",12.0,0.314787,"Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1  and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1  (both P < 0.01).","[{'ForeName': 'Holden W', 'Initials': 'HW', 'LastName': 'Hemingway', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Moore', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Olivencia-Yurvati', 'Affiliation': 'Human Vascular Physiology Laboratory Department of Physiology and Anatomy; Department of Surgery, University of North Texas Health Science Center, United States.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, United States.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00257.2020']
1395,33080122,"Walking in multiple sclerosis improves with tDCS: a randomized, double-blind, sham-controlled study.","OBJECTIVE


To evaluate whether multiple sessions of transcranial direct current stimulation (tDCS) applied to the primary motor (M1) cortex paired with aerobic exercise can improve walking functions in multiple sclerosis (MS).
METHODS


MS participants were recruited for a double-blind, parallel-arm, randomized, sham-controlled trial and assigned to 10 sessions (5 d/wk for 2 weeks) of either active or sham tDCS paired with unloaded cycling for 20 minutes. Stimulation was administered over the left M1 cortex (2.5 mA; anode over C3/cathode over FP2). Gait spatiotemporal parameters were assessed using a wearable inertial sensor (10-meter and 2-minute walking tests). Measurements were collected at baseline, end of tDCS intervention, and 4-week postintervention to test for duration of any benefits.
RESULTS


A total of 15 participants completed the study, nine in the active and six in the sham condition. The active and sham groups were matched according to gender (50% vs. 40% female), neurologic disability (median EDSS 5.5 vs. 5), and age (mean 52.1 ± 12.9 vs. 53.7 ± 9.8 years). The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline. At 4-week follow-up, these improvements were maintained (baseline vs. follow-up: gait speed 0.87 vs. 1.18 m/s, p < 0.001; distance traveled 118.53 vs. 143.82 m, p < 0.001).
INTERPRETATION


Multiple sessions of tDCS paired with aerobic exercise lead to cumulative and persisting improvements in walking and endurance in patients with MS.",2020,"The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline.","['multiple sclerosis (MS', '15 participants completed the study, nine in the active and six in the sham condition', 'median EDSS 5.5 vs. 5), and age (mean 52.1\xa0±\xa012.9 vs. 53.7\xa0±\xa09.8\xa0years', 'patients with MS', 'MS participants']","['transcranial direct current stimulation (tDCS', 'tDCS', 'aerobic exercise', 'active or sham tDCS paired with unloaded cycling for 20\xa0minutes']","['walking functions', 'neurologic disability', 'Gait spatiotemporal parameters', 'duration of any benefits', 'gait speed']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",15.0,0.418567,"The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline.","[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Pilloni', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, SUNY Downstate, New York, NY, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, Binghamton University, New York, NY, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Coghe', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Moffat', 'Affiliation': 'Department of Physical Therapy, New York University, New York, NY, USA.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cocco', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pau', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Charvet', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51224']
1396,33085857,Efficacy of Tocilizumab in Patients Hospitalized with Covid-19.,"BACKGROUND


The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear.
METHODS


We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses.
RESULTS


We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo.
CONCLUSIONS


Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).",2020,"CONCLUSIONS


Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19.","['Patients Hospitalized with Covid-19', 'We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women', 'patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38°C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92', 'hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving', 'moderately ill hospitalized patients with Covid-19', 'The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino']","['mechanical ventilation', 'Tocilizumab', 'placebo', 'interleukin-6 receptor blockade', 'tocilizumab']","['intubation or death, assessed in a time-to-event analysis', 'clinical worsening and discontinuation of supplemental oxygen', 'worsening of disease', 'serious infections', 'hazard ratio for disease worsening', 'still receiving supplemental oxygen', 'median time to discontinuation of supplemental oxygen', 'hazard ratio for intubation or death', 'intubation or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5191366', 'cui_str': '21.7'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",243.0,0.755769,"CONCLUSIONS


Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Frigault', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Serling-Boyd', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ana D', 'Initials': 'AD', 'LastName': 'Fernandes', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Harvey', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Foulkes', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Nora K', 'Initials': 'NK', 'LastName': 'Horick', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Bensaci', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Woolley', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nikiforow', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lin', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sagar', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Schrager', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Huckins', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Axelrod', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Pincus', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Fleisher', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Chana A', 'Initials': 'CA', 'LastName': 'Sacks', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dougan', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'North', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Yuan-Di', 'Initials': 'YD', 'LastName': 'Halvorsen', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Tara K', 'Initials': 'TK', 'LastName': 'Thurber', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Dagher', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Scherer', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Wallwork', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schoenfeld', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Pritha', 'Initials': 'P', 'LastName': 'Sen', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Cory A', 'Initials': 'CA', 'LastName': 'Perugino', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Collier', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Matza', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Janeth M', 'Initials': 'JM', 'LastName': 'Yinh', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Bowman', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Meyerowitz', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Zafar', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Zsofia D', 'Initials': 'ZD', 'LastName': 'Drobni', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': ""D'Silva"", 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Dau', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Lockwood', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Cubbison', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Weber', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Mansour', 'Affiliation': ""From Massachusetts General Hospital (J.H.S., M.J.F., N.J.S.-B., A.D.F., L.H., A.S.F., N.K.H., B.C.H., C.A.S., M.D., C.M.N., Y.-D.H., T.K.T., Z.D., A.S., R.S.W., A.Y.K., S.S., P.S., T.G.N., C.A.P., S.H.U., D.S.C., M.A.M., J.M.Y., K.A.B., E.M., A.Z., Z.D.D., M.B.B., M.K., K.M.D., J.D., M.M.L., M.K.M.), Brigham and Women's Hospital (A.E.W., S.N., B.N.W.), and Boston Medical Center (N.L., M.S.), Boston, North Shore Medical Center, Salem (R.S., A.M.B., C.C.), Newton-Wellesley Hospital, Newton (H.S., D.S.H.), Beth Israel Lahey Health, Burlington (M.A., M.D.P.), and St. Elizabeth's Medical Center, Brighton (J.F.) - all in Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2028836']
1397,33090112,"A Telemonitoring and Hybrid Virtual Coaching Solution ""CAir"" for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients' disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention.
OBJECTIVE


This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD.
METHODS


A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention).
RESULTS


The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently.
CONCLUSIONS


To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20412.",2020,"Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention.
","['Chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['CAir Desk and a hybrid digital coaching intervention', 'Telemonitoring and Hybrid Virtual Coaching Solution ""CAir', 'control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching', 'comprehensive telemonitoring and hybrid virtual coaching solution', 'telemonitoring and hybrid virtual coaching']","['health-related quality-of-life', 'delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0054732', 'cui_str': 'carboxyaminoimidazole ribotide'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.150512,"Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention.
","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gross', 'Affiliation': 'Department of Management, Technology, and Economics, ETH Zürich, Zürich, Switzerland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Kohlbrenner', 'Affiliation': 'Department of Pulmonology, University Hospital of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Clarenbach', 'Affiliation': 'Department of Pulmonology, University Hospital of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Ivankay', 'Affiliation': 'Ecole Polytechnique Fédérale de Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brunschwiler', 'Affiliation': 'IBM Research, Zürich, Rüschlikon, Switzerland.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Nordmann', 'Affiliation': 'docdok.health Ltd., Basel, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'V Wangenheim', 'Affiliation': 'Department of Management, Technology, and Economics, ETH Zürich, Zürich, Switzerland.'}]",JMIR research protocols,['10.2196/20412']
1398,33091844,Operationalizing and selecting outcome measures for the HEALing Communities Study.,"BACKGROUND


The Helping to End Addiction Long-term SM  (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.
METHODS


Priority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites.
RESULTS


The research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing.
CONCLUSIONS


The HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.",2020,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,[],"['buprenorphine', 'HEAL intervention']","['support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths', 'number of opioid overdose deaths, will be measured from death certificate data']",[],"[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0011066', 'cui_str': 'Death certificate'}]",,0.102551,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,"[{'ForeName': 'Svetla', 'Initials': 'S', 'LastName': 'Slavova', 'Affiliation': 'Department of Biostatistics, University of Kentucky, Healthy Kentucky Research Building RB2, Suite 260, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: ssslav2@email.uky.edu.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'LaRochelle', 'Affiliation': 'Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02218, USA. Electronic address: marc.larochelle@bmc.org.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Root', 'Affiliation': 'Department of Geography and Division of Epidemiology, The Ohio State University, and Translational Data Analytics Institute Columbus, The Ohio State University, 1036 Derby Hall, 154 N. Oval Mall, Columbus, OH, 43210, USA. Electronic address: root.145@osu.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Room 1059, Miami, FL, 33136, USA. Electronic address: dfeaster@med.miami.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, 3WFN, MSC 6025, 301 North Stonestreet Avenue, Bethesda, MD, 20892, USA. Electronic address: jennifer.villani@nih.gov.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Knott', 'Affiliation': 'Social, Statistical and Environment Sciences Survey Research Division, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA. Electronic address: cknott@rti.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Talbert', 'Affiliation': 'Division of Biomedical Informatics, University of Kentucky College of Medicine, 267 Healthy Kentucky Research Building, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: jeff.talbert@uky.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mack', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Aimee.mack@osumc.edu.'}, {'ForeName': 'Dushka', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Dushka.crane@osumc.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bernson', 'Affiliation': 'Massachusetts Department of Public Health, 250 Washington Street, Boston, MA, 02108, USA. Electronic address: Dana.Bernson@mass.gov.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Booth', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, 6110 Executive Blvd, Suite 900, Rockville, MD, 20852, USA. Electronic address: abooth@rti.org.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA. Electronic address: sharon.walsh@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108328']
1399,33091856,"Efficacy of cinnamon patch treatment for alleviating symptoms of overactive bladder: A double-blind, randomized, placebo-controlled trial.","BACKGROUND


Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, a double-blind randomized, placebo-controlled trial was conducted in the present study.
MATERIALS AND METHODS


In this 6-week randomized clinical trial conducted in an outpatient setting, 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points. Statistical analyses were performed with IBM SPSS Statistics 20. Groups were compared using an independent sample t-test, Fisher exact test, and Chi-squared test.
RESULTS


In total, 66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP (n ==33) and placebo (n ==33) groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
CONCLUSIONS


Compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.",2020,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","['66 subjects diagnosed as having OAB were enrolled and treated with a', 'overactive bladder (OAB', 'n=33) or CP (n=33', '66 participants (40 women and 26 men), 60.35 ± 12.77 years of age, were included in the\xa0intention-to-treat analyses']","['placebo', 'cinnamon patch (CP', 'cinnamon patch treatment', 'CP']","['OAB symptom score (OABSS', 'efficacy and safety', 'patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume', 'alleviating symptoms of overactive bladder', 'OABSS scores', 'USS scores', 'PPBC scores']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0278024', 'cui_str': 'Residual urine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]",66.0,0.50229,"Treatment with a CP showed statistically significant differences in reductions in OABSS scores (9.70 ± 2.20 to 6.33 ± 2.42), PPBC scores (3.36 ± 0.60 to 2.15 ± 0.83), and USS scores (2.67 ± 0.54 to 1.64 ± 0.60).
","[{'ForeName': 'Lih-Lian', 'Initials': 'LL', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Yuh-Chiang', 'Initials': 'YC', 'LastName': 'Shen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; National Taipei University of Nursing and Health Sciences, 365 Mingde Road, Taipei 11219, Taiwan; National Research Institute of Chinese Medicine, Ministry of Health and Welfare, 155-1 Linong Street, Sec. 2, Taipei 11221, Taiwan.'}, {'ForeName': 'Chih-Chun', 'Initials': 'CC', 'LastName': 'Ke', 'Affiliation': 'Department of Urology, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan.'}, {'ForeName': 'Zuha', 'Initials': 'Z', 'LastName': 'Imtiyaz', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Hui-I', 'Initials': 'HI', 'LastName': 'Chen', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan.'}, {'ForeName': 'Chin-Hsien', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Traditional Chinese Medicine, En Chu Kong Hospital, 399 Fuxing Road, New Taipei City 23702, Taiwan; Department of Cosmetic Science, Chang Gung University of Science and Technology, 261 Wenhua 1st road, Taoyuan City 33303, Taiwan.'}, {'ForeName': 'Mei-Hsien', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'PhD Program in Clinical Drug Development of Herbal Medicine, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Graduate Institute of Pharmacognosy, College of Pharmacy, Taipei Medical University, 250 Wuxing Street, Taipei 11031, Taiwan; Center for Reproductive Medicine & Sciences, Taipei Medical University Hospital, 252 Wuxing Street, Taipei 11031, Taiwan. Electronic address: lmh@tmu.edu.tw.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153380']
1400,33091857,"A standardized polyphenol mixture extracted from poplar-type propolis for remission of symptoms of uncomplicated upper respiratory tract infection (URTI): A monocentric, randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


The most common symptoms of mild upper respiratory tract infections (URTIs) are sore throat, muffled dysphonia, and swelling and redness of the throat, which result from the inflammation process following acute bacterial or viral infection.
HYPOTHESIS/PURPOSE


As propolis is a natural resinous substance traditionally used to maintain oral cavity and upper respiratory tract health due to its antimicrobial and anti-inflammatory properties, the aim of this study is to evaluate the efficacy of an oral spray based on poplar-type propolis extract with a known and standardized polyphenol content, on the remission of the symptoms associated with mild uncomplicated URTIs.
STUDY DESIGN


A monocentric, randomized, double-blind, placebo-controlled clinical trial was performed.
METHODS


This study was conducted in 122 healthy adults who had perceived mild upper respiratory tract infections. Participants, randomly assigned to receive either propolis oral spray (N = 58) or placebo (N = 64), underwent four visits (baseline = t0, after 3 days = t1 and after 5 days = t2 and after a follow-up of 15 days = t3) in an outpatient setting. Propolis oral spray total polyphenol content was 15 mg/ml. The dosage was 2-4 sprays three times/day (corresponding to 12-24 mg of polyphenols/day), for five days. The duration of the study was 8 weeks.
RESULTS


After 3 days of treatment, 83% of subjects treated with propolis oral spray had remission of symptoms, while 72% of subjects in the placebo group had at least one remaining symptom. After five days, all subjects had recovered from all symptoms. This means that resolution from mild uncomplicated URTIs took place two days earlier, instead of taking place in five days as recorded in the control group. There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
CONCLUSION


Propolis oral spray can be used to improve both bacterial and viral uncomplicated URTI symptoms in a smaller number of days without the use of pharmacological treatment, leading to a prompt symptom resolution.",2020,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","['uncomplicated upper respiratory tract infection (URTI', '122 healthy adults who had perceived mild upper respiratory tract infections']","['propolis oral spray (N\xa0=\xa058) or placebo', 'standardized polyphenol mixture extracted from poplar-type propolis', 'placebo']",['remission of symptoms'],"[{'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]","[{'cui': 'C1154184', 'cui_str': 'Oral spray'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",122.0,0.301597,"There was no relationship between the ingestion of propolis oral spray or placebo and adverse reactions.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Esposito', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Emanuele Ugo', 'Initials': 'EU', 'LastName': 'Garzarella', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Bocchino', 'Affiliation': 'Samnium Medical Soc. Cooperative, 82100 Benevento, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""D'Avino"", 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': 'Department of Internal Medicine, Hospital Cardarelli, Via Antonio Cardarelli, 80131 Naples, Italy.'}, {'ForeName': 'Antonio Riccardo', 'Initials': 'AR', 'LastName': 'Buonomo', 'Affiliation': 'Department of Clinical Medicine and Surgery - Section of Infectious Diseases, University of Naples Federico II, via Sergio Pansini 5, 80131 Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, viale Taramelli 24, 27100 Pavia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galeotti', 'Affiliation': 'Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 213/D, 41121 Modena, Italy.'}, {'ForeName': 'Gian Carlo', 'Initials': 'GC', 'LastName': 'Tenore', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Zaccaria', 'Affiliation': 'B Natural R&D Unit, via Gran Sasso 33, 20011 Corbetta (MI), Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Daglia', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, via Domenico Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China. Electronic address: maria.daglia@unina.it.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153368']
1401,33098709,"Is the ""end-of-study guess"" a valid measure of sham blinding during transcranial direct current stimulation?","Studies using transcranial direct current stimulation (tDCS) typically incorporate a fade-in, short-stimulation, fade-out sham (placebo) protocol, which is assumed to be indistinct from a 10-30 min active protocol on the scalp. However, many studies report that participants can dissociate active stimulation from sham, even during low-intensity 1 mA currents. We recently identified differences in the perception of an active (10 min of 1 mA) and a sham (20 s of 1 mA) protocol that lasted for 5 min after the cessation of sham. In the present study we assessed whether delivery of a higher-intensity 2 mA current would exacerbate these differences. Two protocols were delivered to 32 adults in a double-blinded, within-subjects design (active: 10 min of 2 mA, and sham: 20 s of 2 mA), with the anode over the left primary motor cortex and the cathode on the right forehead. Participants were asked ""Is the stimulation on?"" and ""How sure are you?"" at 30 s intervals during and after stimulation. The differences between active and sham were more consistent and sustained during 2 mA than during 1 mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations. Current strength was a good classifier of sensitivity during active tDCS, but exhibited only moderate specificity during sham. The accuracy of the end-of-study guess was no better than chance at predicting sensitivity. Our results indicate that the traditional end-of-study guess poorly reflects the sensitivity of participants to stimulation, and may not be a valid method of assessing sham blinding.",2020,The differences between active and sham were more consistent and sustained during 2mA than during 1mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations.,[],['transcranial direct current stimulation (tDCS'],[],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],,0.212609,The differences between active and sham were more consistent and sustained during 2mA than during 1mA. We then quantified how well participants were able to track the presence and absence of stimulation (i.e. their sensitivity) during the experiment using cross-correlations.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Learmonth', 'Affiliation': 'School of Psychology, University of Glasgow, Glasgow, UK.'}]",The European journal of neuroscience,['10.1111/ejn.15018']
1402,33100049,Effects of Intensive Systolic Blood Pressure Control on All-Cause Hospitalizations.,"Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control. We sought to determine whether the decrease in cardiovascular events seen with intensive blood pressure control is associated with an increased rate of other causes of hospitalization. This is a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial) in 9361 adult participants with hypertension and elevated cardiovascular risk. Participants were randomly assigned to an intensive or standard systolic blood pressure goal (<120 or <140 mm Hg, respectively). The primary outcome was hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events. After excluding hospitalizations linked to SPRINT primary events, there were 4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37). Equivalence testing shows that these hospitalization rates were statistically equivalent at the  P =0.05 level. Of those with hospitalizations, >1 hospitalization was seen in 38.8% of intensive arm participants and 41.9% of standard arm participants ( P =0.08). The mean cumulative count of nonprimary event hospitalizations was comparable between the two arms. The most common causes of hospitalization were cardiovascular (23.6%) followed by injuries, including bone and joint therapeutic procedures (15.7%), infections (12.0%), and nervous systems disorders (10.7%). No categories of hospitalization were statistically more common in the intensive arm compared with the standard arm. Thus, the decrease in cardiovascular events seen with intensive blood pressure control is not associated with an increased rate of other causes of hospitalization. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01206062.",2020,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"['9361 adult participants with hypertension and elevated cardiovascular risk', '4678 participants with a rate of 19.70 hospitalizations per 100 person-years, compared with 4683 participants with a rate of 19.65 ( P =0.37']","['intensive or standard systolic blood pressure goal', 'Intensive Systolic Blood Pressure Control']","['hospitalization rates', 'bone and joint therapeutic procedures', 'categories of hospitalization', 'nervous systems disorders', 'mean cumulative count of nonprimary event hospitalizations', 'cardiovascular events', 'hospitalization rates per 100 person-years for hospitalizations not associated with SPRINT primary events', 'rate of cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517454', 'cui_str': '0.37'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948995', 'cui_str': 'Bone and joint therapeutic procedures'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",9361.0,0.192607,Intensive blood pressure control decreases the rate of cardiovascular events by >25% compared with standard blood pressure control.,"[{'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Comeau', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Marion', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Amret T', 'Initials': 'AT', 'LastName': 'Hawfield', 'Affiliation': 'From the Departments of Internal Medicine (M.V.R., B.I.F., A.T.H.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Langefeld', 'Affiliation': 'Biostatistics and Data Science (M.E.C., M.C.M., C.D.L.), Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15868']
1403,33084149,"Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes.","AIM


To investigate the association of different categories of baseline cardio-metabolic risk factors on the treatment effects of empagliflozin 10 and 25 mg when added as second-line therapy to metformin in patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


Patients aged 18 years or older with HbA1c 7.0%-10.0% were included. Analysis of covariance compared change from baseline to weeks 24 and 76 in HbA1c, body weight (BW) and systolic blood pressure (SBP) by respective baseline categories (HbA1c <8.5/≥8.5%; BW <80/80-90/>90 kg, SBP <130/130-140/>140 mmHg). Analyses were also conducted with a model using continuous covariates of cardio-metabolic factors.
RESULTS


In total, 637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9% [0.9%], BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg) received one or more dose of either empagliflozin 10 mg (n = 217) or 25 mg (n = 213), or placebo (n = 207). At both time points, empagliflozin 10/25 mg versus placebo significantly (P < .0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week 24/76 categorical and continuous models: .0290/.1431 and .0004/.0042, respectively) and in BW (P interaction .1340/.0012 and .0202/<.0001, respectively). Both empagliflozin doses also significantly lowered SBP versus placebo at both time points, with similar efficacy by subgroups of baseline SBP. Adverse events were consistent with the established empagliflozin safety profile across treatment groups.
CONCLUSIONS


Empagliflozin, as add-on to metformin, decreases HbA1c and BW, particularly in patients with higher HbA1c and BW baseline values, and effectively lowers SBP.",2020,"At both time points, empagliflozin 10/25 mg versus placebo significantly (P<0.0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week","['637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9 [0.9] %, BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg', 'patients with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM) on stable background', 'Patients aged ≥18\u2009years with HbA1c ≥7.0 to ≤10.0% were included']","['empagliflozin', 'empagliflozin versus placebo', 'metformin', 'placebo', 'Empagliflozin']","['glycated haemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP', 'baseline HbA1c, body weight and blood pressure', 'Adverse events', 'HbA1c and BW', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",637.0,0.142777,"At both time points, empagliflozin 10/25 mg versus placebo significantly (P<0.0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week","[{'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Prabhav', 'Initials': 'P', 'LastName': 'Trivedi', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14234']
1404,33080378,Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders.,"The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. We will recruit 240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week MBRP group intervention or treatment as usual (TAU) control group. The TAU control group will complete the intervention after 8 weeks. Assessments will take place at baseline, 8 weeks, and 16 weeks. The primary outcome is frequency of opioid use. The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect. This study will contribute to the evidence base regarding MBRP's efficacy in reducing opioid use, as well as contribute to the understanding of the causal mechanisms and factors that modify treatment outcome for MBRP for substance use disorders.",2020,"The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain.","['240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week']","['MBRP', 'mindfulness-based relapse prevention (MBRP', 'MBRP group intervention or treatment as usual (TAU) control group']","['craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain', 'frequency of opioid use', 'emotion regulation skills, executive functioning skills, savoring, and positive and negative affect']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",240.0,0.0377418,"The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Zinzow', 'Affiliation': 'Department of Psychology, Clemson University, Clemson, SC 29634, USA. Electronic address: hzinzow@clemson.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Rennert', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Lopes', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA.'}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Jindal', 'Affiliation': 'Department of Internal Medicine, Prisma Health System, Greenville, SC, 29605, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Stam', 'Affiliation': 'Office of Sponsored Programs, Prisma Health System, Greenville, SC 29605, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mclain', 'Affiliation': 'The Phoenix Center, 1400 Cleveland St., Greenville, SC 29602, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106182']
1405,33080379,Decídetexto: Mobile cessation support for Latino smokers. Study protocol for a randomized clinical trial.,"INTRODUCTION


Latinos, the largest minority group in the U.S., experience tobacco-related disparities, including limited access to cessation resources. Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
OBJECTIVES


To describe the methodology of a randomized clinical trial to evaluate the impact of Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence) at Month 6 among Latino smokers.
METHODS


Latino smokers (N = 618) will be randomized to one of two conditions: 1) Decídetexto or 2) standard of care. Decídetexto is a mobile smoking cessation intervention (available in English and Spanish) that incorporates three integrated components: 1) a tablet-based software that collects smoking-related information to develop an individualized quit plan, 2) a 24-week text messaging counseling program with interactive capabilities, and 3) pharmacotherapy support. Decídetexto follows the Social Cognitive Theory as theoretical framework. Standard of care consists of printed smoking cessation materials along with referral to telephone quitline. Participants in both groups are given access to free pharmacotherapy (nicotine patches or gum) by calling study phone number. Promotores de Salud will rely on community-based approaches and clinical settings to recruit smokers into the study. All participants will complete follow-up assessments at Week 12 and Month 6.
DISCUSSION


If successful, Decídetexto will be ready to be implemented in different community- and clinic-based settings to reduce tobacco-related disparities.",2020,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","['Latino smokers', 'latino smokers', 'Latino smokers (N\u202f=\u202f618']","['Decídetexto or 2) standard of care', 'Decídetexto', 'pharmacotherapy (nicotine patches or gum', 'Decídetexto, a culturally appropriate mobile smoking cessation intervention versus standard care on smoking abstinence (cotinine-verified 7-day point prevalence abstinence']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",[],618.0,0.0411656,"Evidence supports the efficacy of mobile interventions for smoking cessation, which may be greater among Latinos, the highest users of text messaging.
","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cartujano-Barrera', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America. Electronic address: Francisco_Cartujano@URMC.Rochester.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Arana-Chicas', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City, Kansas City, MO, United States of America.""}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Diaz', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Department of Oncology, Georgetown University, Washington, D.C., United States of America.'}, {'ForeName': 'Chinwe', 'Initials': 'C', 'LastName': 'Ogedegbe', 'Affiliation': 'Emergency and Trauma Center, Hackensack University Medical Center, Hackensack, NJ, United States of America.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106188']
1406,33080380,Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.,"BACKGROUND


Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD.
METHODS


This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided.
DISCUSSION


The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT04101773.",2020,"Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact.","['Between June 2020 and May 2022, 558 patients', 'patients with recurrent haemorrhoidal disease (Napoleon trial', 'patients with recurrent HD', 'Patients with recurrent HD grade II and III, ≥18\u202fyears of age and who had at least two RBL treatments in the last three years are eligible for inclusion']","['repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy', 'RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy', 'rubber band ligation versus sutured mucopexy versus haemorrhoidectomy']","['recurrence after 52\u202fweeks and patient-reported symptoms', 'daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact', 'Cost-effectiveness', 'Effectiveness and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",558.0,0.219787,"Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact.","[{'ForeName': 'Sara Z', 'Initials': 'SZ', 'LastName': 'Kuiper', 'Affiliation': 'Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), Universiteitssingel 50, 6229, ER, Maastricht, the Netherlands. Electronic address: s.kuiper@maastrichtuniversity.nl.'}, {'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Dirksen', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands.'}, {'ForeName': 'Merel L', 'Initials': 'ML', 'LastName': 'Kimman', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands.'}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'Van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands.'}, {'ForeName': 'Robin R', 'Initials': 'RR', 'LastName': 'Van Tol', 'Affiliation': 'Department of Surgery, Diakonessenhuis Medical Centre, Bosboomstraat 1, 3582, KE, Utrecht, the Netherlands.'}, {'ForeName': 'Jean W M', 'Initials': 'JWM', 'LastName': 'Muris', 'Affiliation': 'Department of Family Medicine, Maastricht University, Care and Public Health Research Institute (CAPHRI), Universiteitssingel 40, 6229, ER, Maastricht, the Netherlands.'}, {'ForeName': 'Angus J M', 'Initials': 'AJM', 'LastName': 'Watson', 'Affiliation': 'Department of Surgery, Raigmore Hospital, Old Perth Road, IV2 3UJ Inverness, United Kingdom.'}, {'ForeName': 'Jose M C', 'Initials': 'JMC', 'LastName': 'Maessen', 'Affiliation': 'Department of Quality and Safety, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Melenhorst', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.'}, {'ForeName': 'Stéphanie O', 'Initials': 'SO', 'LastName': 'Breukink', 'Affiliation': 'Department of Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands; Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), School for Oncology and Developmental Biology (GROW), Universiteitssingel 50, 6229, ER, Maastricht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106177']
1407,33085647,"Repetitive transcranial magnetic stimulation of the cerebellum improves ataxia and cerebello-fronto plasticity in multiple system atrophy: a randomized, double-blind, sham-controlled and TMS-EEG study.","Cerebellar ataxia is the predominant motor feature of multiple system atrophy cerebellar subtype (MSA-C). Although repetitive transcranial magnetic stimulation (TMS) of the cerebellum is growingly applied in MSA, the mechanism is unknown. We examined dynamic connectivity changes of 20 patients with MSA and 25 healthy controls using TMS combined with electroencephalography. Observations that significantly decreased dynamic cerebello-frontal connectivity in patients have inspired attempts to modulate cerebellar connectivity in order to benefit MSA. We further explore the therapeutic potential of a 10-day treatment of cerebellar intermittent theta burst stimulation (iTBS) in MSA by a randomized, double-blind, sham-controlled trial. The functional reorganization of cerebellar networks was investigated after the end of treatment in active and sham groups. The severity of the symptoms was evaluated using the Scale for Assessment and Rating of Ataxia scores. Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01). Importantly, the neural activity of frontal connectivity from 80 to 100 ms after a single TMS was significantly related to the severity of the disease. Our study provides new proof that cerebellar iTBS improves motor imbalance in MSA by acting on cerebello-cortical plasticity.",2020,"Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01).","['20 patients with MSA and 25 healthy controls using', 'multiple system atrophy']","['repetitive transcranial magnetic stimulation (TMS', 'Repetitive transcranial magnetic stimulation', 'cerebellar intermittent theta burst stimulation (iTBS', 'TMS combined with electroencephalography']","['ataxia scores', 'functional reorganization of cerebellar networks', 'Scale for Assessment and Rating of Ataxia scores', 'neural activity of frontal connectivity', 'cerebello-frontal connectivity and balance functions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.100909,"Patients treated with active stimulation showed an improvement of cerebello-frontal connectivity and balance functions, as revealed by a significant decrease in the ataxia scores (P < 0.01).","[{'ForeName': 'Penghui', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Suobin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.'}]",Aging,['10.18632/aging.103946']
1408,33091586,Cognitive behavioral therapy for insomnia to enhance cognitive function and reduce the rate of Aβ deposition in older adults with symptoms of insomnia: A single-site randomized pilot clinical trial protocol.,"Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD). However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. A recent meta-analysis suggests that approximately 15% of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. Chronic insomnia is the most frequent sleep disorder occurring in at least 40% of older adults. Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD) and demonstrate decline in cognitive function at long-term follow-up. AD is characterized by the accumulation of amyloid-β (Aβ) plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ. An intervention aimed at improving insomnia may be a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the objective of the proposed study is to examine the efficacy of CBT-I on improving cognitive function in older adults with symptoms of insomnia. An exploratory aim is to assess the effect of CBT-I on rate of Aβ accumulation.",2020,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[""Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD"", 'older adults with symptoms of insomnia']","['CBT-I', 'Cognitive behavioral therapy']","['rate of Aβ deposition', 'Chronic insomnia', 'cognitive function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0637426,Individuals with insomnia are more likely to be diagnosed with Alzheimer's Disease (AD),"[{'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America. Electronic address: csiengsukon@kumc.edu.'}, {'ForeName': 'Eryen', 'Initials': 'E', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Williams-Cooke', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ludwig', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eber Silveira', 'Initials': 'ES', 'LastName': 'Beck', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mahnken', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America; Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, United States of America.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Stevens', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Sleep Disorders Clinic, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri - Kansas City School of Medicine, Kansas City, MO, United States of America.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106190']
1409,33091587,Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol.,"BACKGROUND


Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants.
METHODS


Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services).
DISCUSSION


The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03448575.",2020,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","['Youth (SUAY', '800 youth aged 3-17\u202fyears', 'Recruitment occurs at 4 health systems', 'youth with non-psychotic disorders', 'participants']","['EHR-based best practice alert with options to expedite access to psychosocial care', 'antipsychotics']",['person-days of antipsychotic medication use'],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0803332,"The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits.","[{'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Penfold', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Robert.B.Penfold@kp.org.'}, {'ForeName': 'Ella E', 'Initials': 'EE', 'LastName': 'Thompson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hilt', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Schwartz', 'Affiliation': ""Nationwide Children's Hospital, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Denver, CO, USA.'}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Clarke', 'Affiliation': 'Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Ralston', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Hartzler', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R Yates', 'Initials': 'RY', 'LastName': 'Coley', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Akosile', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Benedetto', 'Initials': 'B', 'LastName': 'Vitiello', 'Affiliation': 'Dipartimento di Scienze della Sanità Pubblica e Pediatriche, University of Turin, Turin, Italy.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106184']
1410,33091589,Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial.,"Many individuals with posttraumatic stress disorder (PTSD) also suffer from insomnia and nightmares, which may be symptoms of PTSD or constitute partially independent comorbid disorders. Sleep disturbances are resistant to current treatments for PTSD, and those suffering from PTSD, insomnia, and nightmares have worse PTSD treatment outcomes. In addition, insomnia and nightmares are risk factors for depression, substance abuse, anxiety, and suicide. Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions. CPT does not typically address insomnia or nightmares, and CBT-I&N does not typically address other symptoms of PTSD. There are limited scientific data on how best to provide these therapies to individuals suffering with all three disorders. This project aims to inform the most effective way to treat individuals suffering from PTSD, insomnia, and nightmares, potentially changing the standard of care. U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N = 222) will be randomly assigned to one of the following 18-session individual treatment conditions delivered over 12-weeks: (1) 6 sessions of CBT-I&N followed by 12 sessions of CPT; (2) 12 sessions of CPT followed by 6 sessions of CBT-I&N; or (3) 12 sessions of CPT followed by an additional 6 sessions of CPT. All participants will be assessed at baseline, during treatment, and at 1-week, 1-month, 3-months, and 6-months posttreatment. The primary outcome will be PTSD symptom severity.",2020,Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions.,"['individuals with posttraumatic stress disorder (PTSD', 'individuals suffering with all three disorders', 'comorbid sleep disorders and posttraumatic stress disorder in active duty military', 'U.S. military personnel and recently discharged Veterans who served in support of combat operations following 9/11 aged 18-65 with PTSD, insomnia, and nightmares (N\u202f=\u202f222']","['18-session individual treatment conditions delivered over 12-weeks', 'Cognitive-Behavioral Therapy', 'Cognitive Processing Therapy (CPT', 'CPT']","['Sleep disturbances', 'PTSD symptom severity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",222.0,0.0167908,Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) for PTSD are first line treatments of these conditions.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: DanielJTaylor@arizona.edu.'}, {'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Pruiksma@uthscsa.edu.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Mintz@uthscsa.edu.'}, {'ForeName': 'Danica C', 'Initials': 'DC', 'LastName': 'Slavish', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: Danica.Slavish@unt.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wardle-Pinkston', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: swpinkston@email.arizona.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Tyler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: TylerH@uthscsa.edu.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA. Electronic address: Youngs1@uthscsa.edu.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Scullin', 'Affiliation': 'Department of Psychology and Neuroscience, Baylor University, One Bear Place 97334, Waco, TX 76798, USA. Electronic address: Michael_Scullin@baylor.edu.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Nicholson', 'Affiliation': 'Carl R. Darnall Army Medical Center, 36065 Santa Fe Ave., Fort Hood, TX 76544, USA. Electronic address: Karin.L.Nicholson.mil@mail.mil.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, 150 Hungtington Ave., Boston, MA 02130, USA; Department of Psychiatry, Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA; Department of Psychological and Brain Sciences, Boston University, 64 Cummington Mall, Boston, MA 02215, USA. Electronic address: LitzB@bu.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Dietch', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX 76203-5017, USA. Electronic address: Jessica.Dietch@va.gov.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1121 West Chapel Hill Street, Suite 201, Durham, NC 27701, USA; Durham VA Health Care System, Durham, NC, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, 72 East Concord St., Boston, MA 02118, USA; Behavioral Science Division, National Center for PTSD, VA Boston Healthcare System, 150 South Huntington Ave., Boston, MA 02130, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX 78229, USA; Research and Development Service, South Texas Veterans Health Care System, 7400 Merton Minter, San Antonio, TX 78229, USA; Department of Psychology, University of Texas at San Antonio, 1 UTSA Circle, San Antonio, TX 78249, USA. Electronic address: Petersona3@uthscsa.edu.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Resick', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 1121 West Chapel Hill Street, Suite 201, Durham, NC 27701, USA. Electronic address: Patricia.Resick@duke.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106186']
1411,33092805,"Impact of intraoperative goal-directed fluid therapy on major morbidity and mortality after transthoracic oesophagectomy: a multicentre, randomised controlled trial.","BACKGROUND


Transthoracic oesophagectomy is associated with major morbidity and mortality, which may be reduced by goal-directed therapy (GDT). The aim of this multicentre, RCT was to evaluate the impact of intraoperative GDT on major morbidity and mortality in patients undergoing transthoracic oesophagectomy.
METHODS


Adult patients undergoing transthoracic oesophagectomy were randomised to receive either minimally invasive intraoperative GDT (stroke volume variation <8%, plus systolic BP maintained >90 mm Hg by pressors as necessary) or haemodynamic management left to the discretion of attending senior anaesthetists (control group; systolic BP >90 mm Hg alone). The primary outcome was the incidence of death or major complications (reoperation for bleeding, anastomotic leakage, pneumonia, reintubation, >48 h ventilation). A Cox proportional hazard model was used to examine whether the effects of GDT on morbidity and mortality were independent of other potential confounders.
RESULTS


A total of 232 patients (80.6% male; age range: 36-83 yr) were randomised to either GDT (n=115) or to the control group (n=117). After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09 [95% CI: 0.01-0.67]). GDT was independently associated with morbidity and mortality (hazard ratio: 0.51 [95% CI: 0.30-0.87]; P=0.013).
CONCLUSIONS


Intraoperative GDT may reduce major morbidity and mortality, and shorten hospital stay, after transthoracic oesophagectomy.
CLINICAL TRIAL REGISTRATION


UMIN000018705.",2020,"After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09","['patients undergoing transthoracic oesophagectomy', 'Adult patients undergoing transthoracic oesophagectomy', '232 patients (80.6% male; age range: 36-83 yr']","['intraoperative goal-directed fluid therapy', 'Intraoperative GDT', 'Transthoracic oesophagectomy', 'GDT', 'intraoperative GDT', 'transthoracic oesophagectomy', 'minimally invasive intraoperative GDT (stroke volume variation <8%, plus systolic BP maintained >90 mm Hg by pressors as necessary) or haemodynamic management left to the discretion of attending senior anaesthetists (control group; systolic BP >90 mm Hg alone', 'RCT']","['major morbidity and mortality, and shorten hospital stay', 'episodes of atrial fibrillation', 'morbidity and mortality', 'major morbidity and mortality', 'respiratory failure', 'incidence of death or major complications (reoperation for bleeding, anastomotic leakage, pneumonia, reintubation, >48 h ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",232.0,0.492345,"After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mukai', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Suehiro', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan. Electronic address: suehirokoichi@yahoo.co.jp.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anaesthesiology, Osaka City General Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Juri', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Department of Anaesthesiology, Sumitomo Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Katsuaki', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiovascular Anaesthesiology, Osaka Rosai Hospital, Sakai City, Osaka, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Ohira', 'Affiliation': 'Department of Anaesthesiology, Sumitomo Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Anaesthesiology, Osaka City Juso Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Okutani', 'Affiliation': 'Department of Anaesthesiology, Osaka City General Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.060']
1412,33094733,Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART).,"BACKGROUND


The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity.
OBJECTIVE


We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants' perception regarding the protocol and the use of the app for physical activity qualitatively.
METHODS


We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention.
RESULTS


Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median -198 steps/day [IQR -279 to -103] to 20 steps/day [IQR -204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants' reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals.
CONCLUSIONS


The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.",2020,We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group.,"['Insufficiently Active Adults', 'adults', '18 insufficiently active participants (<10,000 steps/day']","['smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol', 'new group 3 (smartphone app + tailored messages + gamification', 'RBR-8xtc9c', 'smartphone app intervention', 'Smartphone App']","['Physical Activity Levels', 'physical activity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",18.0,0.0312725,We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group.,"[{'ForeName': 'Bárbara De Barros', 'Initials': 'BB', 'LastName': 'Gonze', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Ricardo Da Costa', 'Initials': 'RDC', 'LastName': 'Padovani', 'Affiliation': 'Department of Health, Education and Society, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Maria Do Socorro', 'Initials': 'MDS', 'LastName': 'Simoes', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Lauria', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Neli Leite', 'Initials': 'NL', 'LastName': 'Proença', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Evandro Fornias', 'Initials': 'EF', 'LastName': 'Sperandio', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Thatiane Lopes Valentim Di Paschoale', 'Initials': 'TLVDP', 'LastName': 'Ostolin', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}, {'ForeName': 'Grace Angélica De Oliveira', 'Initials': 'GAO', 'LastName': 'Gomes', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Paula Costa', 'Initials': 'PC', 'LastName': 'Castro', 'Affiliation': 'Department of Gerontology, Federal University of São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Romiti', 'Affiliation': 'Angiocorpore Institute of Cardiovascular Medicine, Santos, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gagliardi', 'Affiliation': 'Angiocorpore Institute of Cardiovascular Medicine, Santos, Brazil.'}, {'ForeName': 'Rodolfo Leite', 'Initials': 'RL', 'LastName': 'Arantes', 'Affiliation': 'Angiocorpore Institute of Cardiovascular Medicine, Santos, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Santos, Brazil.'}]",JMIR research protocols,['10.2196/14322']
1413,33094734,Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study.,"BACKGROUND


Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed.
OBJECTIVE


This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain.
METHODS


The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire.
RESULTS


Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, ""totally agree"" or ""agree""; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).
CONCLUSIONS


Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.",2020,"Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).
","['Patients living with chronic pain (N=50', 'patients living with chronic pain', 'Patients Living With Chronic Pain', 'Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80']","['blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call', 'Digital Self-Management', 'EPIO, an app-based cognitive-behavioral pain self-management intervention program']","['Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire', 'average overall system usability (SUS) score', 'usability questionnaire and the System Usability Scale (SUS', 'HRQoL (bodily pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.111042,"Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049).
","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Bostrøm', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Børøsund', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Varsi', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Eide', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Flakk Nordang', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karlein Mg', 'Initials': 'KM', 'LastName': 'Schreurs', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Waxenberg', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA, United States.'}, {'ForeName': 'Eleshia J', 'Initials': 'EJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychiatry and Psychology, College of Medicine and Science, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Milada', 'Initials': 'M', 'LastName': 'Cvancarova Småstuen', 'Affiliation': 'Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Audun', 'Initials': 'A', 'LastName': 'Stubhaug', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Solberg Nes', 'Affiliation': 'Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Oslo, Norway.'}]",JMIR formative research,['10.2196/23893']
1414,33096222,A randomized trial of an editorial intervention to reduce spin in the abstract's conclusion of manuscripts showed no significant effect.,"OBJECTIVE


To estimate the effect of an intervention compared to the usual peer-review process on reducing spin in the abstract's conclusion of biomedical study reports.
STUDY DESIGN AND SETTING


We conducted a two-arm, parallel-group RCT in a sample of primary research manuscripts submitted to BMJ Open. The authors received short instructions alongside the peer reviewers' comments in the intervention group. We assessed the presence of spin (primary outcome), types of spin, and wording change in the revised abstract's conclusion. Outcome assessors were blinded to the intervention assignment.
RESULTS


Of the 184 manuscripts randomized, 108 (54 intervention, 54 control) were selected for revision and could be evaluated for the presence of spin. The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54). The wording of the revised abstract's conclusion was changed in 34/54 (63%) manuscripts in the intervention group and 26/54 (48%) in the control group. The four prespecified types of spin involved (i) selective reporting (12 in the intervention group vs. 8 in the control group), (ii) including information not supported by evidence (9 vs. 9), and (iii) interpretation not consistent with the study results (14 vs. 18), and (iv) unjustified recommendations for practice (5 vs. 11).
CONCLUSION


These short instructions to authors did not have a statistically significant effect on reducing spin in revised abstract conclusions, and based on the confidence interval, the existence of a large effect can be excluded. Other interventions to reduce spin in reports of original research should be evaluated.
STUDY REGISTRATION


osf.io/xnuyt.",2020,"The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54).","['Of the 184 manuscripts randomised, 108 (54 intervention, 54 control']",['editorial intervention'],['proportion of manuscripts with spin'],"[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}]",,0.0946132,"The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ghannad', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands; Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France. Electronic address: m.ghannad@amsterdamumc.nl.'}, {'ForeName': 'Bada', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Leeflang', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aldcroft', 'Affiliation': 'BMJ, London, UK.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'BMJ, London, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.10.014']
1415,33096225,Using virtual agents to increase physical activity in young children with the virtual fitness buddy ecosystem: Study protocol for a cluster randomized trial.,"BACKGROUND


Designing and implementing a truly self-determined physical activity (PA) intervention has required excessive amounts of labor and expenses that, until recently, have made it prohibitively costly to implement in the field at scale.
METHODS


Guided by self-determination theory, and harnessing the power of consumer-grade interactive technologies, we developed the Virtual Fitness Buddy (VFB) Ecosystem. Designed to foster intrinsic motivation toward adopting PA as a lifestyle change in 6-10-year-old children, the Ecosystem features a mixed-reality kiosk which houses a personalized virtual pet for each user. Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress. The pet alerts parents in real-time by sending text messages and relaying the parents' response to the child, so that parents and children can remain connected about the child's PA progress even when they are physically apart. We aim to implement the kiosk in 12 after-school sites, plus use 12 additional sites as controls, where children can still set and view progress toward their PA goals without access to a virtual pet.
CONCLUSION


The VFB Ecosystem represents a new generation of technology-mediated health interventions for children to promote sustainable PA lifestyle changes. Because the VFB Ecosystem is a cost- and labor-effective solution that integrates consumer-grade technology with low barriers for continued use, it has the potential for rapid diffusion and widespread public health impact.",2020,"Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress.","['young children with the virtual fitness buddy ecosystem', '6-10-year-old children']",['physical activity (PA) intervention'],['physical activity'],"[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0162358', 'cui_str': 'Ecologic Systems'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0209068,"Each time a child visits the kiosk, the pet (a mid-sized dog) automatically detects its owner based on the data from a child's Fitbit, assists the child in setting daily PA goals and provides tailored feedback on the child's PA progress.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Hahn', 'Affiliation': 'Department of Communication, University at Buffalo, State University of New York, United States. Electronic address: Lhahn2@buffalo.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'College of Education, University of Georgia, United States.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Rathbun', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Georgia, United States.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Johnsen', 'Affiliation': 'College of Engineering, University of Georgia, United States.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'YMCA of Metro Atlanta, United States; School of Health Professions, University of Alabama at Birmingham, United States.'}, {'ForeName': 'Sun Joo Grace', 'Initials': 'SJG', 'LastName': 'Ahn', 'Affiliation': 'Grady College of Journalism & Mass Communication, University of Georgia, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106181']
1416,33107329,Effects of Listening to Binaural Beats on Anxiety Levels and Pain Scores in Male Patients Undergoing Cystoscopy and Ureteral Stent Removal: A Randomized Placebo-Controlled Trial.,"Purpose:  To investigate the effects of pure binaural beats on anxiety and pain scores in male patients undergoing diagnostic cystoscopy (DC) and ureteral stent removal (USR) under local anesthesia.  Materials and Methods:  This was a prospective, randomized placebo-controlled study. Patients in the DC group (DCG) and USR group (USRG) were divided into three subgroups according to interventions applied; DCG-1 and USRG-1, patients listened to binaural beats; DCG-2 and USRG-2, patients listened to classical music; and DCG-3 and USRG-3, patients wore headphones, but were not exposed to audio (control group). The State-Trait Anxiety Inventory (STAI) and Visual Analog Scale (VAS) were used for measuring anxiety and pain scores, respectively. Demographic data, initial STAI, tolerance rate of interventions, terminal STAI (STAI-T), differences of STAI (delta STAI, STAI-D), and VAS scores were compared.  Results:  Between July 2019 and March 2020, a total of 252 and 159 eligible male patients for DCG and USRG were included, respectively. After exclusions, remaining patients were DCG-1,  n  = 61; DCG-2,  n  = 73; DCG-3,  n  = 75; USRG-1,  n  = 41; USRG-2,  n  = 50; and USRG-3,  n  = 52. The tolerance rate in binaural beat groups was significantly lower than in other groups ( p  < 0.05 for all). There were significant decreases in terms of STAI-T when DCG-1 and DCG-2 were compared with DCG-3 and USRG-1 and USRG-2 were compared with USRG-3 ( p  < 0.05 for all). There were significant decreases in STAI-D scores when DCG-1 and DCG-2 were compared with DCG-3 and when USRG-1 and USRG-2 were compared with USRG-3 ( p  < 0.001 for all). Binaural beat groups had significantly lower VAS scores than other groups and classical music groups had significantly lower VAS scores than control groups ( p  < 0.05 for all).  Conclusions:  Listening to pure binaural beats may be a simple and effective method to reduce anxiety levels and pain scores associated with the DC and USR procedures in males.",2020,The tolerance rate in binaural beats groups was significantly lower than in other groups (p<0.05 for all).,"['Patients in the DC group (DCG) and USR group (USRG', 'Between July 2019 and March 2020, a total of 252 and 159 eligible male patients for DCG and USRG were included, respectively', 'male patients undergoing diagnostic cystoscopy (DC) and ureteral stent removal (USR) under local anesthesia', 'male patients undergoing cystoscopy and ureteral stent removal']","['listening to binaural beats', 'placebo', 'DCG-1 and USRG-1, patients listened to binaural beats', 'pure binaural beats']","['VAS scores', 'tolerance rate', 'Demographic data, initial STAI (STAI-I), tolerance rate of interventions, terminal STAI (STAI-T), differences of STAI ( delta STAI: STAI-D) and VAS scores', 'anxiety and pain scores', 'STAI-T', 'anxiety levels and pain scores', 'State-Trait Anxiety Inventory (STAI) and Visual Analog Scale (VAS', 'STAI-D scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401483', 'cui_str': 'Diagnostic cystoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1278795', 'cui_str': 'Removal of ureteral stent'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877369', 'cui_str': 'Terminal state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0462665,The tolerance rate in binaural beats groups was significantly lower than in other groups (p<0.05 for all).,"[{'ForeName': 'Mahmut Taha', 'Initials': 'MT', 'LastName': 'Ölçücü', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Kayhan', 'Initials': 'K', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Kaan', 'Initials': 'K', 'LastName': 'Karamık', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Okuducu', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Çağatay', 'Initials': 'Ç', 'LastName': 'Özsoy', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Yasin', 'Initials': 'Y', 'LastName': 'Aktaş', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Çakır', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Ateş', 'Affiliation': 'Department of Urology, Antalya Training and Research Hospital, University of Health Sciences, Antalya, Turkey.'}]",Journal of endourology,['10.1089/end.2020.0353']
1417,33104519,Aerobic exercise induces tumor suppressor p16 INK4a  expression of endothelial progenitor cells in human skeletal muscle.,"Aerobic exercise induces oxidative stress and DNA damage, nevertheless, lowers cancer incidence. It remains unclear how genetic stability is maintained under this condition. Here, we examined the dynamic change of the tumor suppressor p16 INK4a  in cells of skeletal muscle among young men following 60-min of aerobic cycling at 70% maximal oxygen consumption (V̇O 2max ). Rg1 (5 mg, an immunostimulant ginsenoside) and placebo (PLA) were supplemented 1 h before exercise. Data from serial muscle biopsies shows unchanged p16 INK4a+  cells after exercise followed by a considerable increase (+21-fold) in vastus lateralis muscle 3 h later. This increase was due to the accumulation of endothelial progenitor cells (p16 INK4a+ /CD34 + ) surrounding myofibers and other infiltrated nucleated cells (p16 INK4a+ /CD34 - ) in necrotic myofibers. During the Rg1 trial, acute increases of p16 INK4a+  cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later. Rg1 also lowered IL-10 mRNA relative to PLA 3 h after exercise. Post-exercise increases in VEGF mRNA and CD163 +  macrophages were similar for PLA and Rg1 trials. Conclusion: The marked increases in p16 INK4a  protein expression of endothelial progenitor cells in skeletal muscle implicates a protective mechanism for maintaining genetic stability against aerobic exercise. Rg1 accelerates resolution of the exercise-induced stress response.",2020,"During the Rg1 trial, acute increases of p16 INK4a+  cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later.",['human skeletal muscle'],"['Aerobic exercise', 'placebo (PLA']","['accumulation of endothelial progenitor cells', 'oxidative stress and DNA damage, nevertheless, lowers cancer incidence', 'VEGF mRNA and CD163 +  macrophages']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]",,0.0901994,"During the Rg1 trial, acute increases of p16 INK4a+  cells in the muscle occurred immediately after exercise (+3-fold) and reversed near baseline 3 h later.","[{'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Laboratory of Regenerative Medicine in Sports Science, School of Physical Education and Sports Science, South China Normal University, Guangzhou, China.'}, {'ForeName': 'I-Shiung', 'Initials': 'IS', 'LastName': 'Cheng', 'Affiliation': 'Laboratory of Exercise Nutrition, National Taichung University of Education, Taichung, Taiwan.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Saovieng', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Wei-Horng', 'Initials': 'WH', 'LastName': 'Jean', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Chung-Lan', 'Initials': 'CL', 'LastName': 'Kao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital and National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Yang', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital and National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Chinese Medicine, Hualien Tzu Chi Hospital, Tzu Chi Medical Foundation, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Tania Xu Yar', 'Initials': 'TXY', 'LastName': 'Lee', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Ivy', 'Affiliation': 'Department of Kinesiology and Health Education, The University of Texas at Austin, TX 78712, USA.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}]",Aging,['10.18632/aging.103763']
1418,33111424,Near-infrared spectroscopy measures of sternocleidomastoid blood flow during exercise and hyperpnoea.,"NEW FINDINGS


What is the central question of this study? How does sternocleidomastoid blood flow change in response to increasing ventilation and whole-body exercise intensity? What is the main finding and its importance? Sternocleidomastoid blood flow increased with increasing ventilation. For a given ventilation, sternocleidomastoid blood flow was lower during whole-body exercise compared to resting hyperpnoea. These findings suggest that locomotor muscle work exerts an effect on respiratory muscle blood flow that can be observed in the sternocleidomastoid.
ABSTRACT


Respiratory muscle work influences the distribution of blood flow during exercise. Most studies have focused on blood flow to the locomotor musculature rather than the respiratory muscles, owing to the complex anatomical arrangement of respiratory muscles. The purpose of this study was to examine how accessory respiratory (i.e. sternocleidomastoid, and muscles in the intercostal space) muscle blood flow changes in response to locomotor muscle work. Seven men performed 5 min bouts of constant load cycling exercise trials at 30%, 60% and 90% of peak work rate in a randomized order, followed by 5 min bouts of voluntary hyperpnoea (VH) matching the ventilation achieved during each exercise (EX) trial. Blood-flow index (BFI) of the vastus lateralis, sternocleidomastoid (SCM) and seventh intercostal space (IC) were estimated using near-infrared spectroscopy and indocyanine green and expressed relative to resting levels. BFI SCM  was greater during VH compared to EX (P = 0.002) and increased with increasing exercise intensity (P = 0.036). BFI SCM  reached 493 ± 219% and 301 ± 215% rest during VH and EX at 90% peak work rate, respectively. BFI IC  increased to 242 ± 178% and 210 ± 117% rest at 30% peak work rate during VH and EX, respectively. No statistically significant differences in BFI IC  were observed with increased work rate during VH or EX (both P > 0.05). Moreover, there was no observed difference in BFI IC  between conditions (P > 0.05). BFI SCM  was lower for a given minute ventilation during EX compared to VH, suggesting that accessory respiratory muscle blood flow is influenced by whole-body exercise.",2020,No statistically significant differences in BFI IC  were observed with increased work rate during VH or EX (both p>0.05).,[],['voluntary hyperpnoea (VH) matching the ventilation achieved during each exercise (EX'],"['exercise intensity', 'BFI IC', 'Blood-flow index (BFI) of the vastus lateralis (VL), sternocleidomastoid (SCM), and 7 th  intercostal space (IC', 'sternocleidomastoid blood flow', 'respiratory muscle blood flow', 'BFI SCM']",[],"[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0220854', 'cui_str': 'Hyperpnea'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0230136', 'cui_str': 'Structure of intercostal space'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}]",7.0,0.0231482,No statistically significant differences in BFI IC  were observed with increased work rate during VH or EX (both p>0.05).,"[{'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ramsook', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Carli M', 'Initials': 'CM', 'LastName': 'Peters', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Leahy', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Reid A', 'Initials': 'RA', 'LastName': 'Mitchell', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tin', 'Initials': 'T', 'LastName': 'Jasinovic', 'Affiliation': 'Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, Faculty of Education, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': 'Department of Physical Therapy, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': ""Centre for Heart Lung Innovation, University of British Columbia and St Paul's Hospital, Vancouver, British Columbia, Canada.""}]",Experimental physiology,['10.1113/EP089045']
1419,33086137,Effect of resin coating on highly viscous glass ionomer cements: A dynamic analysis.,"OBJECTIVES


This study determined the effects of self-adhesive resin coatings on viscoelastic properties of highly viscous glass ionomer cements (HVGICs) using dynamic mechanical analysis.
MATERIALS AND METHODS


The HVGICs evaluated were Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI). Sixty specimens (12mm x 2mm x 2mm) of each material were fabricated using customized Teflon molds. After initial set, the specimens were removed from their molds, finished, measured and randomly divided into 3 groups of 20. Half the specimens in each group were left uncoated while the remaining half was covered with the respective manufacturers' resin coating. The specimens were subsequently conditioned in distilled water, artificial saliva or citric acid at 37°C for 7 days. The uncoated and coated specimens (n=10) were then subjected to dynamic mechanical testing in flexure mode at 37°C with a frequency of 0.1 to 10Hz. Storage modulus, loss modulus and loss tangent data were subjected to normality testing and statistical analysis using one-way ANOVA/Scheffe's post-hoc test and Ttest at significance level p<0.05.
RESULTS


Mean storage modulus ranged from 1.39 ± 0.36 to 10.80 ± 0.86 GPa while mean loss modulus varied from 0.13 ± 0.03 to 0.70 ± 0.14 GPa after conditioning in the different mediums. Values for loss tangent ranged from 39.4 ± 7.75 to 213.2 ± 20.11 (x10 -3 ). Significant differences in visco-elastic properties were observed between mediums and materials. When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated. Significantly higher values were, however, observed with resin coating when the materials were exposed to citric acid.
CONCLUSION


The visco-elastic properties of HVGICs were influenced by both resin coating and chemical environment.",2020,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.",['highly viscous glass ionomer cements'],"['resin coating', 'self-adhesive resin coatings', 'distilled water, artificial saliva or citric acid']","['ZR, EQ and RV', 'Storage modulus, loss modulus and loss tangent data', 'visco-elastic properties', 'Zirconomer [ZR] (Shofu), Equia Forte [EQ] (GC) and Riva [RV] (SDI']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.033953,"When conditioned in distilled water and artificial saliva,storage modulus was significantly improved when ZR, EQ and RV were uncoated.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Yap', 'Affiliation': 'Department of Dentistry, Ng Teng Fong General Hospital, National University Health System, Singapore; Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia; Faculty of Dentistry, National University of Singapore, Singapore; Duke-NUS Medical School, Singapore; National Dental Research Institute Singapore, National Dental Centre Singapore, Singapore.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Ong', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Yahya', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, University of Malaya, Malaysia. Electronic address: nazlin@um.edu.my.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104120']
1420,33086156,Model and approach for assessing implementation context and fidelity in the HEALing Communities Study.,"BACKGROUND


In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-term SM ) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.
METHODS


HCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly.
DISCUSSION


To help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.",2020,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.",[],"['CTH intervention', 'HEAL (CTH) intervention', 'CTH']","['monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0247065,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Room 204, Lexington, KY, 40508, USA. Electronic address: hannah.knudsen@uky.edu.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Section of Infectious Diseases and Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2014, Boston, MA, 02118, USA. Electronic address: drainoni@bu.edu.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: lg123@columbia.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Huerta', 'Affiliation': 'College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: timothy.huerta@osumc.edu.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Oser', 'Affiliation': 'Department of Sociology and Center on Drug and Alcohol Research, University of Kentucky, 1531 Patterson Office Tower, Lexington, KY, 40506, USA. Electronic address: carrie.oser@uky.edu.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Aldrich', 'Affiliation': 'CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: alison.aldrich@osumc.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2030, Boston, MA, 02118, USA. Electronic address: ecrable@bu.edu.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: bgarner@rti.org.'}, {'ForeName': 'LaShawn M', 'Initials': 'LM', 'LastName': 'Glasgow', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: lglasgow@rti.org.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: dg2121@columbia.edu.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Marks', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, 1100 Veterans Drive, Medical Behavioral Science Building Room 108, Lexington, KY, 40536, USA. Electronic address: katie.marks@uky.edu.'}, {'ForeName': 'Ann Scheck', 'Initials': 'AS', 'LastName': 'McAlearney', 'Affiliation': 'Department of Family and Community Medicine and CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: ann.mcalearney@osumc.edu.'}, {'ForeName': 'Emmanuel A', 'Initials': 'EA', 'LastName': 'Oga', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: eoga@rti.org.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Scalise', 'Affiliation': 'Department of Infectious Disease, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, USA. Electronic address: ariel.scalise@bmc.org.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 520, Columbus, OH, 43210, USA. Electronic address: daniel.walker@osumc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108330']
1421,33086159,Using artificial intelligence tools in answering important clinical questions: The KEYNOTE-183 multiple myeloma experience.,"The phase III, randomized, active-controlled, multicenter, open-label KEYNOTE-183 study (NCT02576977) evaluating pomalidomide and low dose dexamethasone (standard-of-care [SOC]) with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma (rrMM) was placed on full clinical hold by the US FDA on July 03, 2017 due to an imbalance in the number of deaths between arms. Clinically-led subgroup analyses are typically used to shed light on clinical findings. However, this approach is not always successful. We propose a systematic approach using the artificial intelligence tools to identifying risk factors and subgroups contributing to the overall death (prognostic) or to the excess death observed in the pembrolizumab plus SOC arm (predictive) of the KEYNOTE-183 study. In KEYNOTE-183, with a data cutoff date of June 02, 2017, we identified plasmacytoma as a prognostic factor, and ECOG performance status as a predictive factor of death. In addition, a qualitative interaction was observed between ECOG performance status and the treatment arm. The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.",2020,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,['patients with refractory or relapsed and refractory multiple myeloma (rrMM'],['dexamethasone (standard-of-care [SOC]) with or without pembrolizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",[],,0.0440892,The subsequent subgroup analysis based on ECOG performance status confirmed that more deaths were associated with pembrolizumab plus SOC versus SOC alone in patients with ECOG performance status 1.,"[{'ForeName': 'Jason J Z', 'Initials': 'JJZ', 'LastName': 'Liao', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA. Electronic address: a4statistics@gmail.com.'}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hartzel', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Keaven', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Junshui', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Christine K', 'Initials': 'CK', 'LastName': 'Gause', 'Affiliation': 'Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106179']
1422,33091585,Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial.,"Atrial fibrillation (AF) is associated with an increased risk of stroke, enhanced stroke severity, and other comorbidities. However, AF is often asymptomatic, and frequently remains undiagnosed until complications occur. Current screening approaches for AF lack either cost-effectiveness or diagnostic sensitivity; thus, there is interest in tools that could be used for population screening. An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF. Therefore, the aim of the trial is to assess the effectiveness of this risk prediction algorithm combined with diagnostic testing for the identification of AF in a real-world primary care setting. Eligible participants (aged ≥30 years and without an existing AF diagnosis) registered at participating UK general practices will be randomised into intervention and control arms. Intervention arm participants identified at highest risk of developing AF (algorithm risk score ≥ 7.4%) will be invited for a 12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device. Control arm participants will be used for comparison and will be managed routinely. The primary outcome is the number of AF diagnoses in the intervention arm compared with the control arm during the research window. If the trial is successful, there is potential for the risk prediction algorithm to be implemented throughout primary care for narrowing the population considered at highest risk for AF who could benefit from more intensive screening for AF. Trial Registration: NCT04045639.",2020,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","['Eligible participants (aged ≥30\u202fyears and without an existing AF diagnosis) registered at participating UK general practices', 'undiagnosed atrial fibrillation patients']","['12‑lead electrocardiogram (ECG) followed by two-weeks of home-based ECG monitoring with a KardiaMobile device', 'machine learning risk prediction algorithm and diagnostic testing (PULsE-AI']",['number of AF diagnoses'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.124353,"An AF risk prediction algorithm, developed using machine learning from a UK dataset of 2,994,837 patients, was found to be more effective than existing models at identifying patients at risk of AF.","[{'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Hill', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Nathan.Hill@bms.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Arden', 'Affiliation': 'Park Surgery, Chandlers Ford, Hampshire, UK. Electronic address: chrisarden@nhs.net.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beresford-Hulme', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: l.m.beresford91@googlemail.com.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group, Molecular & Clinical Sciences Research Institute, St. George's University of London, London, UK. Electronic address: jcamm@sgul.ac.uk.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clifton', 'Affiliation': 'Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, UK. Electronic address: davidc@robots.ox.ac.uk.'}, {'ForeName': 'D Wyn', 'Initials': 'DW', 'LastName': 'Davies', 'Affiliation': ""St Mary's Hospital, London, UK.""}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Farooqui', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Usman.Farooqui@bms.com.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: jason.gordon@heor.co.uk.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Groves', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: lara.groves@heor.co.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hurst', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: michael.hurst@heor.co.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lawton', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: s.a.lawton@keele.ac.uk.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lister', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Steven.Lister@bms.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'School of Medicine, Keele University, Staffordshire, UK. Electronic address: c.d.mallen@keele.ac.uk.'}, {'ForeName': 'Anne-Celine', 'Initials': 'AC', 'LastName': 'Martin', 'Affiliation': 'Université de Paris, Innovative Therapies in Haemostasis, INSERM, Hôpital Européen Georges Pompidou, Service de Cardiologie, 20 rue Leblanc, Paris, France.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: phil.mcewan@heor.co.uk.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Pollock', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Kevin.Pollock@bms.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rogers', 'Affiliation': 'PHASTAR, London, UK. Electronic address: jennifer.rogers@phastar.com.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Sandler', 'Affiliation': 'Bristol Myers Squibb Pharmaceutical Ltd, Uxbridge, UK. Electronic address: Belinda.Sandler@bms.com.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Sugrue', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK. Electronic address: daniel.sugrue@heor.co.uk.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guys and St Thomas' NHS Foundation Trust, King's College London, London, UK. Electronic address: alexander.cohen@kcl.ac.uk.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106191']
1423,33095411,New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial.,"INTRODUCTION


A significant number of patients with moderate asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS). These patients do not yet meet the criteria for oral corticosteroids (OCS) and monoclonal antibodies. The new anti-chemokine oral drug XC8 could represent an alternative treatment option for these patients. The objective of this trial was to evaluate the effect of different doses of the XC8 in patients with partly controlled asthma in a phase 2a clinical trial.
METHODS


A double-blind, parallel-group, randomized, multicenter, phase 2a trial was conducted at 12 sites in Russia. Patients with asthma were randomized into four groups (n = 30 each) to receive XC8 at 2 mg, 10 mg, 100 mg or placebo once-daily for 12 weeks in addition to low-dose ICS with or without LABA. Efficacy and safety parameters were evaluated at weeks 0, 2, 6, and 12.
RESULTS


No statistically significant difference between the treatment arms in the number of patients with adverse events was observed. The primary endpoint, improvement of forced expiratory volume in 1 s (FEV 1 ) % predicted over 12 weeks compared to placebo, was not statistically significant. The treatment of patients with XC8 (100 mg) resulted in statistically and clinically significant improvements in FEV 1  compared to baseline (7.40% predicted, p < 0.001). Patients with elevated peripheral blood eosinophil count (PBEC, > 300 cells/μl) or serum interferon-γ (IFN-γ) level (> 100 pg/mL) treated with XC8 (100 mg) achieved a statistically significant improvement in FEV 1  (11.33% predicted or 8.69% predicted, respectively, p < 0.05) as compared to the baseline versus the placebo. The strongest effect was observed in patients with both high PBEC and IFN-γ level. Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10). Treatment with XC8 (100 mg) alleviated resistance to maintenance ICS therapy in patients with elevated IFN-γ level.
CONCLUSIONS


Given the high safety, oral route of administration, and efficacy, XC8 may provide a promising treatment option for patients with mild-to-moderate asthma.
TRIAL REGISTRATION


795-30/12/2015 (Ministry of Health Russian Federation), NCT03450434 (ClinicalTrials.gov).",2020,Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10).,"['patients with partly controlled asthma in a phase 2a clinical trial', 'patients with elevated IFN-γ level', 'patients with mild-to-moderate asthma', 'Patients with asthma', 'Asthma Patients with Poor Response to Corticosteroids', 'patients with moderate asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS']","['XC8', 'New Anti-Chemokine Oral Drug XC8', 'placebo', 'XC8 at 2\xa0mg, 10\xa0mg, 100\xa0mg or placebo once-daily for 12\xa0weeks in addition to low-dose ICS with or without LABA']","['serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10', 'Efficacy and safety parameters', 'elevated peripheral blood eosinophil count (PBEC,\u2009>\u2009300 cells/μl) or serum interferon-γ (IFN-γ) level ', 'forced expiratory volume in 1\xa0s (FEV 1 ', 'FEV', 'FEV 1', 'number of patients with adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.382345,Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C-C motif ligand 2 (CCL2) and C-X-C motif chemokine 10 (CXCL10).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Romanova', 'Affiliation': 'EURRUS Biotech GmbH, Tulln, Austria. jr.romanova@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Chikina', 'Affiliation': 'PHARMENTERPRISES LLC, Moscow, Russia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Rydlovskaya', 'Affiliation': 'PHARMENTERPRISES LLC, Moscow, Russia.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Pohl', 'Affiliation': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Renner', 'Affiliation': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Zeifman', 'Affiliation': 'Chemimmune Therapeutics LLC, Moscow, Russia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Chuchalin', 'Affiliation': 'Institute of Pulmonology, Federal Medical and Biological Agency, Moscow, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Nebolsin', 'Affiliation': 'PHARMENTERPRISES LLC, Moscow, Russia.'}]",Pulmonary therapy,['10.1007/s41030-020-00134-5']
1424,33096362,Simulation strategies to increase nursing student clinical competence in safe medication administration practices: A quasi-experimental study.,"BACKGROUND


Nursing student medication errors often result from deficits in knowledge and application of fundamental safe administration practices. Factors such as high faculty-student ratios and legal restrictions have decreased clinical learning opportunities for nursing students to practice safe medication administration in the clinical setting. Evidence suggests that use of a structured medication safety enhancement (MSE) simulation program can significantly improve student knowledge and competency in safe medication administration.
PURPOSE


To examine the effects of an educational strategy using a MSE simulation program with integrated technology on the medication administration knowledge, competency, and confidence levels of undergraduate nursing students.
METHODS


This quasi-experimental replication study designed and implemented medication simulations enhanced by integrated information technologies in an undergraduate-nursing curriculum. Third-year BSN students (n = 83) were randomized into intervention or control groups. Control groups participated in standard training while the intervention group received additional clinical simulation experience and debriefing sessions focused on medication safety practices. Participant knowledge was measured using pre/post Medication Safety Knowledge Assessment (MSKA) and competency was evaluated using the Medication Safety Critical Element Checklist (MSCEC).
RESULTS


The MSKA and MSCEC were analyzed using two-sided independent t-tests. Post-test knowledge scores increased in both groups but results were not statistically significant (α = 0. 05). Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
CONCLUSION


Findings suggest that educators should consider high fidelity simulation as an evidence-based teaching strategy to engage students in understanding and implementing medication safety practices in the clinical setting.",2020,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","['undergraduate-nursing curriculum', 'Third-year BSN students (n\xa0=\xa083', 'undergraduate nursing students']",['standard training while the intervention group received additional clinical simulation experience and debriefing sessions'],"['Post-test knowledge scores', 'Medication Safety Critical Element Checklist (MSCEC']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1098180', 'cui_str': 'bis((di-n-butyl 3,6-dioxaheptanoato)tin)'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",83.0,0.0131788,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Craig', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: sjw5y@virginia.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kastello', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: jck9e@virginia.edu.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Cieslowski', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: bjc6h@virginia.edu.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Rovnyak', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA.'}]",Nurse education today,['10.1016/j.nedt.2020.104605']
1425,33098161,An effective hydroquinone alternative for topical skin lightening.,"BACKGROUND


Many skin lightening preparations containing hydroquinone, kojic acid, arbutin, and deoxyarbutin are toxic to melanocytes.
OBJECTIVE


This research examined a new skin lightening agent from a family of gem difluorocompounds 2-[2-(2,4-difluorophenyl)-2-propen-1-yl]-1,3-propanediol that also function as tyrosinase inhibitors. This ingredient does not exhibit melanocyte toxicity yet is capable of inducing skin lightening. This research compared the gem difluorocompound, TFC-1067, to hydroquinone evaluating both tolerability and efficacy for lightening facial dyschromia.
METHOD


48 nonpregnant and non-nursing healthy female subjects age 25-70 years skin types I-IV with mild-to-moderate facial dyschromia were randomized to receive either study product or 2% hydroquinone cream. Subject and investigator tolerability and efficacy assessments were made at baseline, week 4, week 8, and week 12. Dermaspectrophotometer readings from normal skin and a pigmented target area were obtained. All subjects underwent facial photography at each visit.
RESULTS


TFC-1067 and 2% hydroquinone produced statistically significant skin lightening after 8 weeks of use, but only hydroquinone lightened the normal skin. This pattern continued into week 12 where both products significantly lightened dyschromic skin, but hydroquinone also lightened the normal skin, which is not always desirable.",2020,"RESULTS


TFC-1067 and 2% hydroquinone produced statistically significant skin lightening after 8 weeks of use, but only hydroquinone lightened the normal skin.","['I-IV with mild to moderate facial dyschromia', '48 nonpregnant and non-nursing healthy female subjects age 25-70 years skin types']","['hydroquinone', 'TFC-1067', 'hydroquinone cream']",[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C1252137', 'cui_str': 'hydroquinone Topical Cream'}]",[],,0.0150092,"RESULTS


TFC-1067 and 2% hydroquinone produced statistically significant skin lightening after 8 weeks of use, but only hydroquinone lightened the normal skin.","[{'ForeName': 'Zoe Diana', 'Initials': 'ZD', 'LastName': 'Draelos', 'Affiliation': 'Dermatology Consulting Services, PLLC, High Point, NC, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Deliencourt-Godefroy', 'Affiliation': 'TFChem, Val de Reuil, France.'}, {'ForeName': 'Lénaïg', 'Initials': 'L', 'LastName': 'Lopes', 'Affiliation': 'TFChem, Val de Reuil, France.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13771']
1426,33098852,"Ethinyl estradiol vs estradiol valerate in combined oral contraceptives - Effect on glucose tolerance: A randomized, controlled clinical trial.","OBJECTIVE


To compare the effects of two formulations of combined oral contraceptives (COCs), estradiol valerate (EV) and ethinyl estradiol (EE) combined with dienogest (DNG), and DNG-only, on glucose tolerance.
STUDY DESIGN


We performed a randomized, controlled 9-week clinical trial. Inclusion criteria were: age 18-35 years, regular menstrual cycle (28 ± 7 days), no polycystic ovaries, non-smoking, no contraindications for COC use and a 2-month wash-out from hormonal contraceptive use. The women were randomized to EV + DNG (n = 20), EE + DNG (n = 20), and DNG-only (n = 19), and evaluated at baseline, at 4-5 weeks and 8-9 weeks of treatment. Study medications were used continuously for 63 days. Primary outcome measure was change in the whole-body insulin sensitivity index (Matsuda index) derived from the oral glucose tolerance test (OGTT) over the treatment period. Secondary outcome measures were area under curves (AUC) of glucose and insulin, homeostatic model assessment - insulin resistance (HOMA-IR) and Insulin Sensitivity Index (ISI).
RESULTS


Fifty-nine women enrolled, and 56 women completed the study. The Matsuda index changed from baseline as follows (mean percentage change, mean change [95%CI]): DNG-only -12%, -1.45 [95%CI -3.22-0.325] P = 0.10; EV + DNG + 2.7%, -0.10 [-1.34 to 1.14] P = 0.86; EE + DNG -5.5%, -1.02 [-2.51 to 0.46] P = 0.16, comparing the groups P = 0.27. There were no clinically significant differences in glucose tolerance between the COC groups, but the DNG-only group showed an improvement in the 2-h glucose levels (5.5 [95%CI 5.0-6.0] to 4.7 mmol/l [4.2-5.2], P = 0.001).
CONCLUSION


We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks.
IMPLICATIONS


Combinations of both ethinyl estradiol and natural estradiol (estradiol valerate) with dienogest (DNG), as well as DNG-only, seem metabolically safe in young and healthy women in short-term continuous use.",2020,"We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks.","['Inclusion criteria were: age 18-35 years, regular menstrual cycle (28±7 days), no polycystic ovaries, non-smoking, no contraindications for COC use and a 2-month wash-out from hormonal contraceptive use', 'young and healthy women in short-term continuous use', 'Fifty-nine women enrolled, and 56 women completed the study', 'healthy, young, normal-weight women']","['ethinyl estradiol and natural estradiol (estradiol valerate) with dienogest (DNG', 'Ethinyl Estradiol vs Estradiol Valerate', 'EV+DNG', 'combined oral contraceptives (COCs), estradiol valerate (EV) and ethinyl estradiol (EE) combined with dienogest (DNG), and DNG']","['change in the whole-body insulin sensitivity index (Matsuda index', 'area under curves (AUC) of glucose and insulin, homeostatic model assessment - insulin resistance (HOMA-IR) and Insulin Sensitivity Index (ISI', '2-hour glucose levels', 'oral glucose tolerance test (OGTT', 'glucose tolerance', 'Glucose Tolerance', 'Matsuda index']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",59.0,0.12365,"We found no clinically significant differences between EV and EE combined with DNG and DNG-only on glucose tolerance in healthy, young, normal-weight women, indicating that these preparations appear close to neutral regarding glucose metabolism when used continuously for nine weeks.","[{'ForeName': 'Annina', 'Initials': 'A', 'LastName': 'Haverinen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kangasniemi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, Kajaanintie 50, PO 5000, 90014 Oulu, Finland.'}, {'ForeName': 'Kaisu', 'Initials': 'K', 'LastName': 'Luiro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Piltonen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, Kajaanintie 50, PO 5000, 90014 Oulu, Finland.'}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland.'}, {'ForeName': 'Juha S', 'Initials': 'JS', 'LastName': 'Tapanainen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Haartmaninkatu 2, PO 140, 00029 Helsinki, Finland; Department of Obstetrics and Gynecology, University of Oulu, Oulu University Hospital and Medical Research Centre PEDEGO Research Unit, Kajaanintie 50, PO 5000, 90014 Oulu, Finland. Electronic address: juha.tapanainen@helsinki.fi.'}]",Contraception,['10.1016/j.contraception.2020.10.014']
1427,33098739,Early parenting intervention accelerates inhibitory control development among CPS-involved children in middle childhood: A randomized clinical trial.,"Children at risk for neglect or abuse are vulnerable to delays in inhibitory control development. Prior findings suggest that early parenting interventions that target parental sensitivity and responsiveness during infancy can improve executive function outcomes of high-risk children during preschool years; however, little is known about how persistent these gains are through middle childhood. Participants included 76 CPS-involved children who were randomly assigned to either the ABC intervention (N = 32) or the Developmental Education for Families (DEF) control intervention (N = 44), and 53 low-risk children. Children completed the Stop Signal Reaction Time (SSRT) paradigm at ages 8 and 10. Intervention group predicted performance on the SSRT at age 8 such that children who received the ABC intervention and children in the low-risk group performed significantly better than children who received the DEF intervention (ABC vs. DEF: Cohen's d = 0.92; low-risk group vs. DEF: d = 0.56). The performances of the ABC and the low-risk groups were not statistically different. There were no significant group differences in SSRT performance at age 10. These findings demonstrate that the ABC intervention has long-term beneficial effects on inhibitory control development in children with a history of early caregiving adversity. A video abstract of this article can be viewed at https://youtu.be/P9oLyfo7pYA.",2020,The performances of the ABC and the low-risk groups were not statistically different.,"['N = 44), and 53 low-risk children', 'Participants included 76 CPS-involved children', 'high-risk children during preschool years', 'children with a history of early caregiving adversity', 'CPS-Involved Children in Middle Childhood']","['DEF intervention (ABC vs. DEF', 'ABC intervention (N = 32) or the Developmental Education for Families (DEF) control intervention', 'ABC intervention', 'Early Parenting Intervention']","['Stop Signal Reaction Time (SSRT) paradigm', 'SSRT performance', 'executive function outcomes']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.0420485,The performances of the ABC and the low-risk groups were not statistically different.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Korom', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Tabachnick', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Palmwood', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Simons', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}]",Developmental science,['10.1111/desc.13054']
1428,33099307,GP- and practice-related variation in ambulatory sensitive hospitalisations of older primary care patients.,"BACKGROUND


Reducing ambulatory sensitive hospitalisations (ASHs) is a strategy to control spending on hospital care and to improve quality of primary health care. This research investigated whether ASH rates in older people varied by GP and practice characteristics.
METHODS


We identified ASHs from the national dataset of hospital events for 3755 community-dwelling participants aged 75+ enrolled in a cluster randomised controlled trial involving 60 randomly selected general practices in three regions in New Zealand. Poisson mixed models of 36-month ASH rates were fitted for the entire sample, for complex participants, and non-complex participants. We examined variation in ASH rates according to GP- and practice-level characteristics after adjusting for patient-level predictors of ASH.
RESULTS


Lower rates of ASHs were observed in female GPs (IRR 0.83, CI 0.71 to 0.98). In non-complex participants, but not complex participants, practices in more deprived areas had lower ASH rates (4% lower per deprivation decile higher, IRR 0.96, CI 0.92 to 1.00), whereas main urban centre practices had higher rates (IRR 1.84, CI 1.15 to 2.96). Variance explained by these significant factors was small (0.4% of total variance for GP sex, 0.2% for deprivation, and 0.5% for area type). None of the modifiable practice-level characteristics such as home visiting and systematically contacting patients were significantly associated with ASH rates.
CONCLUSIONS


Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people. Where there were significant associations, the contribution to overall variance was minimal. It also remains unclear whether lower ASH rates in older people represents underservicing or less overuse of hospital services, particularly for the relatively well patient attending practices in less central, more disadvantaged communities. Thus, reducing ASHs through primary care redesign for older people should be approached carefully.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Register ACTRN12609000648224 .",2020,Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people.,"['We identified ASHs from the national dataset of hospital events for 3755 community-dwelling participants aged 75+ enrolled in a cluster randomised controlled trial involving 60 randomly selected general practices in three regions in New Zealand', 'older people varied by GP and practice characteristics', 'older primary care patients', 'Australian and New Zealand']",['GP- and practice-related variation'],"['ASH rates', '36-month ASH rates']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0994524', 'cui_str': 'Ash'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",60.0,0.115396,Only a few GP and non-modifiable practice characteristics were associated with variation in ASH rates in 60 New Zealand practices interested in a trial about care of older people.,"[{'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Palapar', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Wilkinson-Meyers', 'Affiliation': 'Health Systems Section, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lumley', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Ngaire', 'Initials': 'N', 'LastName': 'Kerse', 'Affiliation': 'Department of General Practice and Primary Health Care, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. n.kerse@auckland.ac.nz.'}]",BMC family practice,['10.1186/s12875-020-01285-9']
1429,33106968,"Impact of early intervention with onabotulinumtoxinA treatment in adult patients with post-stroke lower limb spasticity: results from the double-blind, placebo-controlled, phase 3 REFLEX study.","The aim of this study in patients with post-stroke lower limb spasticity (PSLLS) was to evaluate the relationship between time of onabotulinumtoxinA treatment relative to stroke and efficacy outcomes. This was a phase 3, international, multicenter, randomized, 12-week, double-blind study, followed by a repeated treatment, open-label extension. Patients were aged 18-85 years with PSLLS (Modified Ashworth Scale [MAS] ≥ 3) of the ankle with the most recent stroke occurring ≥ 3 months before screening. Patients (double-blind phase) were randomized (n = 468) to onabotulinumtoxinA 300-400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and ≤ 100 U, optional lower limb muscles (flexor digitorum longus, flexor hallucis longus, flexor digitorum brevis, extensor hallucis, and rectus femoris]) or placebo. Primary endpoint: MAS change from baseline (average score of weeks 4 and 6). Secondary endpoints: physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12). When stratified by time since stroke (≤ 24 months, n = 153; > 24 months, n = 315, post hoc), patients treated ≤ 24 months post-stroke experienced greater improvements from baseline versus placebo in MAS (- 0.31 vs - 0.17), CGI (0.49 vs 0.12), and passive GAS scores (week 12, 0.37 vs 0.26). A ≥  - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04). OnabotulinumtoxinA 300-400 U was well tolerated, with no new safety findings.",2020,"A ≥  - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04).","['Patients were aged 18-85\xa0years with PSLLS (Modified Ashworth Scale [MAS]\u2009≥\u20093) of the ankle with the most recent stroke occurring\u2009≥\u20093\xa0months before screening', 'adult patients with post-stroke lower limb spasticity', 'patients with post-stroke lower limb spasticity (PSLLS']","['onabotulinumtoxinA 300-400 U (300 U, mandatory ankle muscles (gastrocnemius, soleus, tibialis posterior); and\u2009≤\u2009100 U, optional lower limb muscles', 'placebo', 'onabotulinumtoxinA treatment', 'OnabotulinumtoxinA']","['physician-assessed Clinical Global Impression of Change (CGI) average score of weeks 4 and 6 and physician-assessed Goal Attainment Scale (GAS; active and passive, weeks 8 and 12', 'MAS change from baseline (average score of weeks 4 and 6', 'active scores', 'GAS scores', 'passive GAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0224463', 'cui_str': 'Tibialis posterior muscle structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.394937,"A ≥  - 1-point improvement in active (week 12; p = 0.04) and passive (week 8; p = 0.02) GAS scores versus placebo was achieved by more patients treated ≤ 24 months post-stroke; in patients treated > 24 months post-stroke, improvements were only observed in active scores (week 8; p = 0.04).","[{'ForeName': 'Atul T', 'Initials': 'AT', 'LastName': 'Patel', 'Affiliation': 'Kansas City Bone and Joint Clinic, Overland Park, KS, USA. apatel@kcbj.com.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Ward', 'Affiliation': 'Faculty of Health and North Staffordshire Rehabilitation Centre, Haywood Hospital, Staffordshire University, Stoke on Trent, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Geis', 'Affiliation': 'Brooks Rehabilitation/Physician Group, Halifax Health, Daytona Beach, FL, USA.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Jost', 'Affiliation': 'Department of Neurology, University of Freiburg, Freiburg, Baden-Württemberg, Germany.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Allergan Plc, Madison, NJ, USA.'}, {'ForeName': 'Rozalina', 'Initials': 'R', 'LastName': 'Dimitrova', 'Affiliation': 'Allergan Plc, Irvine, CA, USA.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02251-6']
1430,33105281,An Implementation-Effectiveness Study of a Perioperative Delirium Prevention Initiative for Older Adults.,"BACKGROUND


Postoperative delirium is a common and serious problem for older adults. To better align local practices with delirium prevention consensus guidelines, we implemented a 5-component intervention followed by a quality improvement (QI) project at our institution.
METHODS


This hybrid implementation-effectiveness study took place at 2 adult hospitals within a tertiary care academic health care system. We implemented a 5-component intervention: preoperative delirium risk stratification, multidisciplinary education, written memory aids, delirium prevention postanesthesia care unit (PACU) orderset, and electronic health record enhancements between December 1, 2017 and June 30, 2018. This was followed by a department-wide QI project to increase uptake of the intervention from July 1, 2018 to June 30, 2019. We tracked process outcomes during the QI period, including frequency of preoperative delirium risk screening, percentage of ""high-risk"" screens, and frequency of appropriate PACU orderset use. We measured practice change after the interventions using interrupted time series analysis of perioperative medication prescribing practices during baseline (December 1, 2016 to November 30, 2017), intervention (December 1, 2017 to June 30, 2018), and QI (July 1, 2018 to June 30, 2019) periods. Participants were consecutive older patients (≥65 years of age) who underwent surgery during the above timeframes and received care in the PACU, compared to a concurrent control group <65 years of age. The a priori primary outcome was a composite of perioperative American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use (Beers PIM) medications. The secondary outcome, delirium incidence, was measured in the subset of older patients who were admitted to the hospital for at least 1 night.
RESULTS


During the 12-month QI period, preoperative delirium risk stratification improved from 67% (714 of 1068 patients) in month 1 to 83% in month 12 (776 of 931 patients). Forty percent of patients were stratified as ""high risk"" during the 12-month period (4246 of 10,494 patients). Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12. We analyzed medication use in 7212, 4416, and 8311 PACU care episodes during the baseline, intervention, and QI periods, respectively. Beers PIM administration decreased from 33% to 27% to 23% during the 3 time periods, with adjusted odds ratio (aOR) 0.97 (95% confidence interval [CI], 0.95-0.998; P = .03) per month during the QI period in comparison to baseline. Delirium incidence was 7.5%, 9.2%, and 8.5% during the 3 time periods with aOR of delirium of 0.98 (95% CI, 0.91-1.05, P = .52) per month during the QI period in comparison to baseline.
CONCLUSIONS


A perioperative delirium prevention intervention was associated with reduced administration of Beers PIMs to older adults.",2020,Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12.,"['older adults', 'Participants were consecutive older patients (≥65 years of age) who underwent surgery during the above timeframes and received care in the PACU, compared to a concurrent control group <65 years of age', 'Older Adults', '7212, 4416, and 8311 PACU care episodes during the baseline, intervention, and QI periods, respectively', '2 adult hospitals within a tertiary care academic health care system']","['5-component intervention: preoperative delirium risk stratification, multidisciplinary education, written memory aids, delirium prevention postanesthesia care unit (PACU', 'Perioperative Delirium Prevention Initiative']","['preoperative delirium risk stratification', 'frequency of preoperative delirium risk screening, percentage of ""high-risk"" screens, and frequency of appropriate PACU orderset use', 'delirium incidence', 'composite of perioperative American Geriatrics Society Beers Criteria for Potentially Inappropriate Medication Use (Beers PIM) medications', 'Delirium incidence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085554', 'cui_str': 'Episodes of Care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4042847', 'cui_str': 'de Beers Criteria'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",10494.0,0.0624519,Appropriate PACU orderset use in high-risk patients increased from 19% in month 1 to 85% in month 12.,"[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Donovan', 'Affiliation': 'From the Division of Critical Care Medicine, Department of Anesthesia and Perioperative Care.'}, {'ForeName': 'Matthias R', 'Initials': 'MR', 'LastName': 'Braehler', 'Affiliation': 'Department of Anesthesia and Perioperative Care.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Robinowitz', 'Affiliation': 'Department of Anesthesia and Perioperative Care.'}, {'ForeName': 'Ann A', 'Initials': 'AA', 'LastName': 'Lazar', 'Affiliation': 'Department of Preventive and Dental Sciences.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Finlayson', 'Affiliation': 'Department of Surgery and Philip R. Lee Institute for Health Policy Studies.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Division of Geriatrics, Department of Medicine.'}, {'ForeName': 'Vanja C', 'Initials': 'VC', 'LastName': 'Douglas', 'Affiliation': 'Department of Neurology, University of California, San Francisco, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Whitlock', 'Affiliation': 'Department of Anesthesia and Perioperative Care.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005223']
1431,33109638,"Translating new evidence into clinical practice: a quasi-experimental controlled before-after study evaluating the effect of a novel outreach mentoring approach on knowledge, attitudes and confidence of health workers providing HIV and infant feeding counselling in South Africa.","OBJECTIVES


We report the effectiveness of a mentoring approach to improve health workers' (HWs') knowledge, attitudes and confidence with counselling on HIV and infant feeding.
DESIGN


Quasi-experimental controlled before-after study.
SETTING


Randomly selected primary healthcare clinics (n=24 intervention, n=12 comparison); two districts, South Africa.
PARTICIPANTS


All HWs providing infant feeding counselling in selected facilities were invited.
INTERVENTIONS


Three 1-2 hours, on-site workshops over 3-6 weeks.
PRIMARY OUTCOME MEASURES


Knowledge (22 binary questions), attitude (21 questions-5-point Likert Scale) and confidence (19 questions-3-point Likert Scale). Individual item responses were added within each of the attitude and confidence domains. The respective sums were taken to be the domain composite index and used as a dependent variable to evaluate intervention effect. Linear regression models were used to estimate the mean score difference between intervention and comparison groups postintervention, adjusting for the mean score difference between them at baseline. Analyses were adjusted for participant baseline characteristics and clustering at health facility level.
RESULTS


In intervention and comparison sites, respectively: 289 and 131 baseline and 253 and 114 follow-up interviews were conducted (August-December 2017). At baseline there was no difference in mean number of correctly answered knowledge questions; this differed significantly at follow-up (15.2 in comparison; 17.2 in intervention sites (p<0.001)). At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively). Controlling for confounders, interactions between time and intervention group and preintervention values, the attitude score was 5.1 points significantly higher in intervention versus comparison groups.
CONCLUSION


A participatory, low-intensity on-site mentoring approach to disseminating updated infant feeding guidelines improved HWs' knowledge, attitudes and confidence more than standard dissemination via a circular. Further research is required to evaluate the effectiveness, feasibility and sustainability of this approach at scale.",2020,"At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively).","['health workers providing HIV and infant feeding counselling in South Africa', 'Randomly selected primary healthcare clinics (n=24 intervention, n=12 comparison); two districts, South Africa', 'All HWs providing infant feeding counselling in selected facilities were invited']","['novel outreach mentoring approach', 'mentoring approach']","[""health workers' (HWs') knowledge, attitudes and confidence"", 'Knowledge (22 binary questions), attitude (21 questions-5-point Likert Scale) and confidence (19 questions-3-point Likert Scale', 'mean number of correctly answered knowledge questions', 'attitude score', 'mean attitude and confidence scores towards breast feeding']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",,0.0339395,"At follow-up, the mean attitude and confidence scores towards breast feeding were better in intervention versus comparison sites (p<0.001 and p=0.05, respectively).","[{'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Goga', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa Ameena.Goga@mrc.ac.za.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': 'Health Systems Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Manda', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Tshifhiwa', 'Initials': 'T', 'LastName': 'Nkwenika', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Haskins', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'John', 'Affiliation': 'School of Education, University of KwaZulu Natal, Pietermaritzburg, South Africa.'}, {'ForeName': 'Ingunn M S', 'Initials': 'IMS', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Feucht', 'Affiliation': 'Department of Paediatrics, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dhansay', 'Affiliation': 'Division of Human Nutrition and Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rollins', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Kroon', 'Affiliation': 'Department of Neonatology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Shuaib', 'Initials': 'S', 'LastName': 'Kauchali', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Horwood', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}]",BMJ open,['10.1136/bmjopen-2019-034770']
1432,33118957,Virtual Reality-Based Treatment for Military Members and Veterans With Combat-Related Posttraumatic Stress Disorder: Protocol for a Multimodular Motion-Assisted Memory Desensitization and Reconsolidation Randomized Controlled Trial.,"BACKGROUND


Military members are at elevated risk of operational stress injuries, including posttraumatic stress disorder (PTSD) and moral injury. Although psychotherapy can reduce symptoms, some military members may experience treatment-resistant PTSD. Multimodular motion-assisted memory desensitization and reconsolidation (3MDR) has been introduced as a virtual reality (VR) intervention for military members with PTSD related to military service. The 3MDR intervention incorporates exposure therapy, psychotherapy, eye movement desensitization and reconsolidation, VR, supportive counselling, and treadmill walking.
OBJECTIVE


The objective of this study is to investigate whether 3MDR reduces PTSD symptoms among military members with combat-related treatment-resistant PTSD (TR-PTSD); examine the technology acceptance and usability of the Computer Assisted Rehabilitation ENvironment (CAREN) and 3MDR interventions by Canadian Armed Forces service members (CAF-SMs), veterans, 3MDR clinicians, and operators; and evaluate the impact on clinicians and operators of delivering 3MDR.
METHODS


This is a mixed-methods waitlist controlled crossover design randomized controlled trial. Participants include both CAF-SMs and veterans (N=40) aged 18-60 years with combat-related TR-PTSD (unsuccessful experience of at least 2 evidence-based trauma treatments). Participants will also include clinicians and operators (N=12) who have been trained in 3MDR and subsequently utilized this intervention with patients. CAF-SMs and veterans will receive 6 weekly 90-minute 3MDR sessions. Quantitative and qualitative data will be collected at baseline and at 1, 3, and 6 months postintervention. Quantitative data collection will include multiomic biomarkers (ie, blood and salivary proteomic and genomic profiles of neuroendocrine, immune-inflammatory mediators, and microRNA), eye tracking, electroencephalography, and physiological data. Data from outcome measures will capture self-reported symptoms of PTSD, moral injury, resilience, and technology acceptance and usability. Qualitative data will be collected from audiovisual recordings of 3MDR sessions and semistructured interviews. Data analysis will include univariate and multivariate approaches, and thematic analysis of treatment sessions and interviews. Machine learning analysis will be included to develop models for the prediction of diagnosis, symptom severity, and treatment outcomes.
RESULTS


This study commenced in April 2019 and is planned to conclude in April 2021. Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.
CONCLUSIONS


The goal of this study is to utilize qualitative and quantitative primary and secondary outcomes to provide evidence for the effectiveness and feasibility of 3MDR for treating CAF-SMs and veterans with combat-related TR-PTSD. The results will inform a full-scale clinical trial and stimulate development and adaptation of the protocol to mobile VR apps in supervised clinical settings. This study will add to knowledge of the clinical effectiveness of 3MDR, and provide the first comprehensive analysis of biomarkers, technology acceptance and usability, moral injury, resilience, and the experience of clinicians and operators delivering 3MDR.
TRIAL REGISTRATION


ISRCTN Registry 11264368; http://www.isrctn.com/ISRCTN11264368.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20620.",2020,"Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.
","['Participants include both CAF-SMs and veterans (N=40) aged 18-60 years with combat-related TR-PTSD (unsuccessful experience of at least 2 evidence-based trauma treatments', 'military members with PTSD related to military service', 'Military Members and Veterans With Combat-Related Posttraumatic Stress Disorder', 'military members with combat-related treatment-resistant PTSD (TR-PTSD', 'Participants will also include clinicians and operators (N=12) who have been trained in 3MDR and subsequently utilized this intervention with patients', 'veterans with combat-related TR-PTSD']","['Virtual Reality-Based Treatment', '3MDR', 'psychotherapy', '3MDR intervention', 'Multimodular motion-assisted memory desensitization and reconsolidation (3MDR', 'Computer Assisted Rehabilitation ENvironment (CAREN) and 3MDR interventions']","['capture self-reported symptoms of PTSD, moral injury, resilience, and technology acceptance and usability']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3714797', 'cui_str': 'Military service'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4505439', 'cui_str': 'Moral Injury'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0757549,"Study results will guide the further evolution and utilization of 3MDR for military members with TR-PTSD and will have utility in treating other trauma-affected populations.
","[{'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Smith-MacDonald', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Miguel-Cruz', 'Affiliation': 'Department of Occupational Therapy, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Pike', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'van Gelderen', 'Affiliation': ""ARQ Centrum'45, Diemen, Netherlands.""}, {'ForeName': 'Liana', 'Initials': 'L', 'LastName': 'Lentz', 'Affiliation': 'School of Health Studies, Western University, London, ON, Canada.'}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Shiu', 'Affiliation': 'Defence Research and Development Canada, Toronto Research Centre, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Tang', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sawalha', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Greenshaw', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Shawn G', 'Initials': 'SG', 'LastName': 'Rhind', 'Affiliation': 'Defence Research and Development Canada, Toronto Research Centre, Toronto, ON, Canada.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Norbash', 'Affiliation': 'Canadian Forces Health Services, Department of National Defense, Edmonton, AB, Canada.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jetly', 'Affiliation': 'Department of Mental Health, Canadian Forces Health Services, Department of National Defense, Ottawa, ON, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Brémault-Phillips', 'Affiliation': 'Heroes in Mind, Advocacy and Research Consortium, Faculty of Rehabilitation, University of Alberta, Edmonton, AB, Canada.'}]",JMIR research protocols,['10.2196/20620']
1433,33118959,App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.,"BACKGROUND


Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all.
OBJECTIVE


This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone.
METHODS


The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020.
RESULTS


The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022.
CONCLUSIONS


This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20308.",2020,selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain.,['People With Low Back Pain'],"['usual care with usual care alone', 'selfBACK']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",[],[],,0.135628,selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain.,"[{'ForeName': 'Charlotte Diana Nørregaard', 'Initials': 'CDN', 'LastName': 'Rasmussen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Malene Jagd', 'Initials': 'MJ', 'LastName': 'Svendsen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Wood', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Barbara I', 'Initials': 'BI', 'LastName': 'Nicholl', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Louise Fleng', 'Initials': 'LF', 'LastName': 'Sandal', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Denmark, Odense M, Denmark.'}, {'ForeName': 'Paul Jarle', 'Initials': 'PJ', 'LastName': 'Mork', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Denmark, Odense M, Denmark.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Bach', 'Affiliation': 'Department of Computer Science, Faculty of Information Technology and Electrical Engineering, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Mette Jensen', 'Initials': 'MJ', 'LastName': 'Stochkendahl', 'Affiliation': 'Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}]",JMIR research protocols,['10.2196/20308']
1434,33119010,"Comparison of probiotic yogurt and ordinary yogurt consumption on serum Pentraxin3, NT-proBNP, oxLDL, and ApoB100 in patients with chronic heart failure: a randomized, triple-blind, controlled trial.","BACKGROUND AND AIMS


Nowadays, the potential beneficial effects of probiotic yogurt as a functional food has raised much interest. Thus, the aim of this study was to compare the probiotic yogurt and ordinary yogurt consumption on some indices in patients with chronic heart failure (CHF).
METHODS AND RESULTS


In this randomized, triple-blind clinical trial, 90 patients with CHF were randomly allocated into two groups to take either probiotic yogurt or ordinary yogurt for 10 weeks. The serum levels of pentraxin3 (PTX3), N-terminal pro-brain natriuretic peptide (NT-proBNP), oxidized low density lipoprotein (oxLDL), and apolipoprotein B100 (ApoB100) were measured at the baseline and at the end of week 10. P-Value <0.05 was defined as statistically significant. Final analyses were performed on 78 patients. The levels of PTX3 and oxLDL in both the groups decreased significantly after 10 weeks, and these reductions were greater in the probiotic group, where the difference between the groups was statistically significant for oxLDL (P-value: 0.051, adjusted P-value: 0.010) but not significant for PTX3 (P-value: 0.956, adjusted P-value: 0.236). The changes in the serum NT-proBNP levels were not statistically significant between the groups (P-value: 0.948, adjusted P-value: 0.306). ApoB100 significantly decreased in the control group compared to the probiotic group and the difference between the groups was significant at first but was not significant after adjusting for the confounders (P-value: 0.004, adjusted P-value: 0.280).
CONCLUSION


The serum oxLDL significantly reduced due to probiotic yogurt consumption after 10 weeks compared to ordinary yogurt; thus, it may be useful for improving the oxidative status of CHF patients. The clinical trial registry number is IRCT20091114002709N48 (https://www.irct.ir/IRCT20091114002709N48, registered 12 March 2018).",2020,"The changes in the serum NT-proBNP levels were not statistically significant between the groups (P-value: 0.948, adjusted P-value: 0.306).","['patients with chronic heart failure', 'patients with chronic heart failure (CHF', '90 patients with CHF']","['oxLDL', 'probiotic yogurt or ordinary yogurt', 'probiotic yogurt and ordinary yogurt consumption']","['serum levels of pentraxin3 (PTX3), N-terminal pro-brain natriuretic peptide (NT-proBNP), oxidized low density lipoprotein (oxLDL), and apolipoprotein B100 (ApoB100', 'serum Pentraxin3, NT-proBNP, oxLDL, and ApoB100', 'levels of PTX3 and oxLDL', 'serum NT-proBNP levels', 'ApoB100']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0205666', 'cui_str': 'Apolipoprotein B-100'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}]",90.0,0.0292987,"The changes in the serum NT-proBNP levels were not statistically significant between the groups (P-value: 0.948, adjusted P-value: 0.306).","[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Pourrajab', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. shidfar.f@iums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Naderi', 'Affiliation': 'Rajaie Cardiovascular, Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mofid', 'Affiliation': 'Department of food science and technology, Faculty of nutrition and food technology, National nutritional and food technology research institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Hajahmadi', 'Affiliation': 'Department of Cardiology, Rasoul Akram General Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dehnad', 'Affiliation': 'Center for Educational Research in Medical Sciences (CERMS), Department of Medical Education, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. shidfar.f@iums.ac.ir.'}]",Food & function,['10.1039/d0fo01014f']
1435,33113596,Randomized Controlled Trial of Riluzole Augmentation for Posttraumatic Stress Disorder: Efficacy of a Glutamatergic Modulator for Antidepressant-Resistant Symptoms.,"OBJECTIVE


Current pharmacologic treatments for posttraumatic stress disorder (PTSD) have shown limited efficacy, prompting a call to investigate new classes of medications. The current study investigated the efficacy of glutamate modulation with riluzole augmentation for combat-related PTSD symptoms resistant to treatment with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
METHODS


A randomized, double-blind, placebo-controlled, parallel trial was conducted at Walter Reed National Military Medical Center and Syracuse VA Medical Center between December 2013 and November 2017. Veterans and active duty service members with combat-related PTSD (per the Clinician Administered PTSD Scale [CAPS]) who were not responsive to SSRI or SNRI pharmacotherapy were randomized to 8-week augmentation with a starting dose of 100 mg/d of riluzole (n = 36) or placebo (n = 38) and assessed weekly for PTSD symptoms, anxiety, depression, disability, and side effects.
RESULTS


Intent-to-treat analyses (N = 74) of the primary outcome (CAPS for DSM-IV) showed no significant between-group difference in change in overall PTSD symptoms (F = 0.64, P = .422), with a small effect size (d = 0.25). There was clinically significant within-group improvement in overall PTSD symptoms in both groups, with a greater mean (SD) decrease in CAPS score in the riluzole group (-21.1 [18.9]) than in the placebo group (-16.7 [17.2]). Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.
CONCLUSIONS


Although preliminary, the exploratory findings of this study offer some evidence that riluzole augmentation of an SSRI or SNRI may selectively improve PTSD hyperarousal symptoms without changes in overall PTSD symptoms, depression, anxiety, or disability. Additional investigation of the mechanism of the efficacy of riluzole for hyperarousal symptoms is warranted.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02155829.",2020,"Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.
","['posttraumatic stress disorder (PTSD', 'Posttraumatic Stress Disorder', 'Veterans and active duty service members with combat-related PTSD (per the Clinician Administered PTSD Scale [CAPS]) who were not responsive to SSRI or SNRI pharmacotherapy', 'Walter Reed National Military Medical Center and Syracuse VA Medical Center between December 2013 and November 2017']","['Riluzole Augmentation', 'selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs', 'riluzole', 'placebo', 'riluzole augmentation']","['overall PTSD symptoms, depression, anxiety, or disability', 'depression, anxiety, or disability severity', 'PTSD symptoms, anxiety, depression, disability, and side effects', 'overall PTSD symptoms', 'PTSD Checklist-Specific-Subscale D', 'PTSD hyperarousal symptoms', 'CAPS score', 'hyperarousal symptoms']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.270344,"Exploratory analyses of PTSD symptom clusters showed significantly greater improvement on hyperarousal symptoms in the riluzole group as measured by the PTSD Checklist-Specific-Subscale D (d = 0.48) and near-significant findings on the CAPS Subscale D. Riluzole augmentation was not superior to placebo on change in depression, anxiety, or disability severity.
","[{'ForeName': 'Patricia T', 'Initials': 'PT', 'LastName': 'Spangler', 'Affiliation': 'Patricia Spangler, PhD, Department of Psychiatry, Uniformed Services University, 4301 Jones Bridge Rd, Bethesda, MD 20816. patricia.spangler.ctr@usuhs.edu.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Dempsey', 'Affiliation': 'Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Possemato', 'Affiliation': 'Veterans Administration Center for Integrated Healthcare, Syracuse, New York, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bartolanzo', 'Affiliation': 'Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Aliaga', 'Affiliation': 'Center for the Study of Traumatic Stress, Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics & Pathophysiology Branch, National Institute of Mental Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Vythilingam', 'Affiliation': 'Senior Mental Health Advisor, Office of the Assistant Secretary for Health, Washington, DC, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Benedek', 'Affiliation': 'Department of Psychiatry, Uniformed Services University, Bethesda, Maryland, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13233']
1436,33115285,A Randomized Controlled Ixekizumab Vs Secukinumab Trial to Study the Impact on Sexual Activity in Adult Patients with Genital Psoriasis.,"Introduction : There is limited data on the effects of biologic therapies on genital psoriasis and sexual activity. Recently, Ixekizumab was reported to be effective.  Aim : To compare the efficacy of ixekizumab and secukinumab for the treatment of genital psoriasis and sexual inadequacy in adult patients with moderate-to-severe psoriasis.  Patients and methods : We assessed adult patients with moderate-to-severe psoriasis having genital involvement. They were randomly assigned in a 1:1 ratio to receive either ixekizumab (80 mg/2 weeks after 160-mg initial dose) or secukinumab (300 mg subcutaneous injection at Weeks 0, 1, 2, 3, and 4 then every 4 weeks). The severity was assessed using Genital Psoriasis Symptoms Scale (GPSS), and impact on sexual health by evaluating the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ).  Results : Twenty eight patients on ixekizumab, and 26 on secukinumab showed improvement in genital psoriasis symptoms, beginning week 2 (GPSS total and individual items), and from week 4 onwards, improvement in sexual activity was seen with both drugs.  Conclusion : Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors. Limitations included small number of patients and lack of follow-up period.",2020,Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors.,"['Adult Patients with Genital Psoriasis', 'adult patients with moderate-to-severe psoriasis having genital involvement', '28 patients on', 'adult patients with moderate-to-severe psoriasis']","['Ixekizumab', 'secukinumab', 'ixekizumab', 'ixekizumab and secukinumab', 'Ixekizumab Vs Secukinumab']","['Genital Psoriasis Symptoms Scale (GPSS), and impact on sexual health by evaluating the Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ', 'Sexual Activity', 'genital psoriasis and sexual activity', 'sexual activity', 'genital psoriasis symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0624372,Both genital psoriasis symptoms and impact on sexual activity improved rapidly and significantly with both the IL-17 inhibitors.,"[{'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'AlMutairi', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Kuwait University , Kuwait City, Kuwait.'}, {'ForeName': 'Bayoumy Ibrahim', 'Initials': 'BI', 'LastName': 'Eassa', 'Affiliation': 'Department of Dermatology, Farwaniya Hospital , Kuwait City, Kuwait.'}]",Expert opinion on biological therapy,['10.1080/14712598.2021.1843629']
1437,33115831,Effect of the Carer Support Needs Assessment Tool intervention (CSNAT-I) in the Danish specialised palliative care setting: a stepped-wedge cluster randomised controlled trial.,"BACKGROUND


The Carer Support Needs Assessment Tool intervention (CSNAT-I) has been shown to improve end-of-life care support for informal caregivers. This study investigated the impact of the CSNAT-I on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark.
METHODS


A stepped-wedge cluster randomised controlled trial with nine clusters (ie, SPC teams). Outcome measures were collected using caregiver questionnaires at baseline (T0) and 2-week (T1) and 4-week (T2) follow-up.
RESULTS


A total of 437 caregivers were enrolled (control group, n=255; intervention group, n=182). No intervention effect was found on the primary outcome, caregiver strain at T1 (p=0.1865). However, positive effects were found at T1 and T2 on attention to caregivers' well-being (p<0.0001), quality of information and communication (p<0.0001), amount of information (T1: p=0.0002; T2: p<0.0001), involvement (T1: p=0.0045; T2: p<0.0001), talking about greatest burdens (p<0.0001) and assistance in managing greatest burdens (p<0.0001). The effect sizes of these differences were medium or large and seemed to increase from T1 to T2. At T1, positive effects were found on distress (p=0.0178) and home care responsibility (p=0.0024). No effect was found on the remaining outcomes.
CONCLUSION


Although no effect was found on caregiver strain, the CSNAT-I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals.
TRIAL REGISTRATION NUMBER


NCT03466580.",2020,"I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals.
","['on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark', '437 caregivers were enrolled (control group, n=255; intervention group, n=182']","['Carer Support Needs Assessment Tool intervention (CSNAT-I', 'CSNAT-I']","['caregiver questionnaires at baseline (T0) and 2-week (T1) and 4-week (T2) follow-up', 'quality of information and communication (p<0.0001), amount of information (T1', 'distress (p=0.0178) and home care responsibility', 'caregiver strain, the CSNAT', ""caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals""]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4075872', 'cui_str': 'Carer Support Needs Assessment Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",437.0,0.218476,"I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lund', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark line.lund.01@regionh.dk.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten Aagaard', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Annemette', 'Initials': 'A', 'LastName': 'Blach', 'Affiliation': 'Hospice Soendergaard, Maaloev, Denmark.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rosted', 'Affiliation': 'Department of Oncology and Palliative Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Bollig', 'Affiliation': 'Palliative Care Team, Medical Department Soenderborg/Toender, South Jutland Hospital, Soenderborg, Denmark.'}, {'ForeName': 'Gitte Irene', 'Initials': 'GI', 'LastName': 'Juhl', 'Affiliation': 'Palliative Care Unit, Department of Oncology and Palliative Care, North Zealand Hospital, Frederikssund, Denmark.'}, {'ForeName': 'Hanne Bollerup', 'Initials': 'HB', 'LastName': 'Farholt', 'Affiliation': 'Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Winther', 'Affiliation': 'Palliative Care Unit, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Laursen', 'Affiliation': 'Department of Palliative Care, Rigshospitalet - Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hasse', 'Affiliation': 'Diakonissestiftelsens Hospice, Frederiksberg, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Weensgaard', 'Affiliation': 'Arresoedal Hospice, Frederiksvaerk, Denmark.'}, {'ForeName': 'Mai-Britt', 'Initials': 'MB', 'LastName': 'Guldin', 'Affiliation': 'Palliative Care Team, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ewing', 'Affiliation': 'Centre for Family Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Grande', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002467']
1438,33118309,Glycaemic profiles of diverse patients with type 2 diabetes using basal insulin: MOBILE study baseline data.,"Basal insulin is often prescribed to patients with suboptimally controlled type 2 diabetes (T2D); however, its therapeutic efficacy is inadequate in many. During the MOBILE study's baseline phase, we evaluated 173 participants' continuous glucose monitoring (CGM) data (mean ± SD age 57 ± 9 years; 50% female; HbA1c 9.1% [range 7.1%-11.6%]; 40% using sulphonylureas; 19% using NPH; reported self-monitored blood glucose [SMBG] frequency median 1.0 checks/day) who were using basal, but not prandial insulin. Blinded CGM data were recorded for 10 days prior to randomization. The mean glucose value was 208 ± 47 mg/dL and it was lowest in the early morning. Mean time in the 70-180 mg/dL range was 9.6 ± 6.1 hours/day (40% ± 25%). Hyperglycaemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) hours/day with glucose greater than 180 and 250 mg/dL, respectively. Hypoglycaemia was infrequent (median [IQR] 0 [0, 4.3] minutes/day [0.0% {0.0%, 0.3%}] with glucose less than 70 mg/dL). Blinded CGM highlights the limitations of infrequent SMBG in basal insulin users with T2D and allows characterization of hyperglycaemia and hypoglycaemia in basal insulin users with suboptimal control. The MOBILE study randomized phase will define the benefits of using real-time CGM compared with SMBG in this population.",2020,"Hyperglycemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) h/day with glucose >180 and >250 mg/dL, respectively.","['patients with sub-optimally controlled type 2 diabetes (T2D', 'diverse patients with type 2 diabetes using basal insulin', ""173 participants' continuous glucose monitoring (CGM) data (mean±SD age 57±9\u2009years; 50% female; glycated hemoglobin 9.1% [range, 7.1-11.6%]; 40% using sulfonylureas; 19% using NPH; reported self-monitored blood glucose [SMBG] frequency median 1.0 checks/day) who were using basal, but not prandial insulin""]",[],"['Glycemic profiles', 'Hypoglycemia', 'Mean time', 'Mean glucose value', 'Hyperglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",,0.0775585,"Hyperglycemia was extensive with medians of 14.7 (61%) and 5.0 (20.9%) h/day with glucose >180 and >250 mg/dL, respectively.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, California.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Ruedy', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Martens', 'Affiliation': 'International Diabetes Center, Park Nicollet Clinic, Brooklyn Center, Minnesota.'}, {'ForeName': 'Shichun', 'Initials': 'S', 'LastName': 'Bao', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Nelly M', 'Initials': 'NM', 'LastName': 'Njeru', 'Affiliation': 'Dexcom, Inc., San Diego, California.'}, {'ForeName': 'Stayce E', 'Initials': 'SE', 'LastName': 'Beck', 'Affiliation': 'Dexcom, Inc., San Diego, California.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Price', 'Affiliation': 'Dexcom, Inc., San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14238']
1439,31023842,French experience of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.,"AIMS


To evaluate safety and efficacy of balloon pulmonary angioplasty (BPA) in a large cohort of patients with chronic thromboembolic pulmonary hypertension (CTEPH).
METHODS


From 2014 to 2017, 184 inoperable CTEPH patients underwent 1006 BPA sessions. Safety and efficacy during the first 21 months (initial period) were compared with those of the last 21 months (recent period). A total of 154 patients had a full evaluation after a median duration of 6.1 months.
RESULTS


Overall, there was a significant improvement in New York Heart Association functional class, 6-min walk distance (mean change +45 m), and a significant decrease in mean pulmonary artery pressure (PAP) and in pulmonary vascular resistance (PVR) by 26% and 43%, respectively. The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period  versus  30% and 49% in the recent period, respectively (p<0.05). The main complications included lung injury, which occurred in 9.1% of 1006 sessions (13.3% in the initial period  versus  5.9% in the recent period; p<0.001). Per-patient multivariate analysis revealed that baseline mean PAP and the period during which BPA procedure was performed (recent  versus  initial period) were the strongest factors related to the occurrence of lung injury. 3-year survival was 95.1%.
CONCLUSION


This study confirms that a refined BPA strategy improves short-term symptoms, exercise capacity and haemodynamics in inoperable CTEPH patients with an acceptable risk-benefit ratio. Safety and efficacy improve over time, underscoring the unavoidable learning curve for this procedure.",2019,"The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period  versus  30% and 49% in the recent period, respectively (p<0.05).","['patients with chronic thromboembolic pulmonary hypertension (CTEPH', '154 patients had a full evaluation after a median duration of 6.1\u2005months', 'From 2014 to 2017, 184 inoperable CTEPH patients underwent 1006 BPA sessions', 'inoperable CTEPH patients with an acceptable risk-benefit ratio', 'chronic thromboembolic pulmonary hypertension']","['balloon pulmonary angioplasty', 'balloon pulmonary angioplasty (BPA']","['mean pulmonary artery pressure (PAP) and in pulmonary vascular resistance (PVR', 'Safety and efficacy', 'New\xa0York Heart Association functional class, 6-min walk distance', 'safety and efficacy', 'short-term symptoms, exercise capacity and haemodynamics', '3-year survival', 'mean PAP and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",184.0,0.0307558,"The percentage decreases of mean PAP and PVR were 22% and 37% in the initial period  versus  30% and 49% in the recent period, respectively (p<0.05).","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brenot', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jaïs', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France xavier.jais@gmail.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Taniguchi', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia Alonso', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Gerardin', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Mussot', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Mercier', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fabre', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Parent', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Jevnikar', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montani', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Savale', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Fadel', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Simonneau', 'Affiliation': 'Univ. Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.'}]",The European respiratory journal,['10.1183/13993003.02095-2018']
1440,33124985,"Comment on ""Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial"".",,2020,,[],[],[],[],[],[],,0.0744143,,"[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saishoji', 'Affiliation': 'Department of General Internal Medicine, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiroshita', 'Affiliation': 'Department of Pulmonology, Kameda Medical Center, Kamogawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Nephrology and Dialysis, Kyoritsu Hospital, Kawanishi, Japan.'}]",Journal of medical Internet research,['10.2196/21505']
1441,33091681,Concreteness of thoughts and images during suppression and expression of worry.,"The avoidance theory of worry (Borkovec, Alcaine, & Behar, 2004) posits that the verbal-linguistic (versus imagery-based) nature of worry elicits abstract (versus concrete) processing, which inhibits affective responding and generates a host of negative consequences. Although suppression of worrisome thinking is maladaptive (Purdon, 1999), expression of worry using vivid imagery may increase concreteness of worrisome thinking and facilitate more adaptive emotional responding. The present study examined whether the valence, content, and expression of mentation impacts concreteness of thought. Participants (N = 62) were randomly assigned to verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics. Participants were also randomly assigned to engage in a 5-min period of suppressing or expressing the target stimuli before engaging in 5-min of freely expressing the targets. Verbalizations of mental content were coded for level of abstractness/concreteness. For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness. In addition, for neutral (but not worrisome) stimuli, an initial period of suppression was associated with increased concreteness during subsequent expression. Imagery-based mentation about worrisome stimuli may not enhance concreteness; moreover, unlike suppression of neutral stimuli, suppression of worrisome stimuli may maintain, rather than ameliorate, abstractness of thought.",2020,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.",['Participants (N\xa0=\xa062'],"['verbalize their thoughts while engaging in either verbal-linguistic- or imagery-based mentation about both worrisome and neutral topics', 'Imagery-based mentation about worrisome stimuli']",['Concreteness of thoughts and images during suppression and expression of worry'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",62.0,0.0172364,"For neutral stimuli, imagery-based mentation led to greater concreteness than did verbal-linguistic mentation; however, for worrisome stimuli, imagery-based mentation did not enhance concreteness.","[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Jendrusina', 'Affiliation': 'University of Illinois at Chicago, USA; VA Ann Arbor Healthcare System, USA. Electronic address: alexanderjendrusina@gmail.com.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Stevens', 'Affiliation': 'University of Illinois at Chicago, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Nahin', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Legrand', 'Affiliation': 'University of Vermont, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Behar', 'Affiliation': 'City University of New York - Hunter College, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103754']
1442,33091706,Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open-label randomized controlled clinical trial.,"STUDY OBJECTIVE


The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.
DESIGN


Prospective, randomized, open-label clinical trial.
SETTING


University-affiliated hospital.
PATIENTS


Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.
INTERVENTIONS


Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.
MEASUREMENTS


All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
MAIN RESULTS


There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11-0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16-0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.
CONCLUSION


We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.",2020,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","['Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery', 'elderly patients undergoing major non-cardiac surgery', 'elderly surgical patients', 'University-affiliated hospital', 'Elderly patients undergoing non-cardiac major surgery']","['methylene blue (MB', 'Methylene blue', 'intravenous infusion of 2\xa0mg/kg\xa0MB within 60\xa0min immediately after anesthetic induction, or control group (n\xa0=\xa0124), who receiving equal volume saline', 'MB']","['POD/POCD and levels of SOD or HCY', 'incidences of POD and early POCD', 'incidence of early POCD', 'postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD', 'incidence of POD', 'delirium and neuropsychological batteries', 'adverse events', 'perioperative adverse events', 'Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY', 'early postoperative cognitive disorders']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",248.0,0.0572685,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","[{'ForeName': 'Yixu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China.'}, {'ForeName': 'Ruijing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University,Shanghai 200032, PR China. Electronic address: snapzhang@aliyun.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110108']
1443,33091760,The social curse: Evidence for a moderating effect of shared social identity on contagious stress reactions.,"Contagious stress describes the transmission of a stress response from a distressed individual (target) to an uninvolved observer. Building on social identity theory, we hypothesize that a shared social identity between the observer and the target as compared to a personal identity increases the likelihood of contagious endocrine and psychological stress responses. Participants underwent the experiment in groups of four or five individuals. After experimentally inducing either a shared social identity or a personal identity, one participant in each group (N target  = 27) was randomly chosen to undergo the Trier Social Stress Test (TSST), while being observed by the rest of the group (N observer  = 89). Salivary cortisol and psychological stress responses were assessed repeatedly during the experiment. As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %). No effect of our manipulation on psychological stress responses was found. We also tested whether observers' trait empathy moderates contagious stress and found no support for this moderation.",2020,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).",[],['Trier Social Stress Test (TSST'],"['Salivary cortisol and psychological stress responses', 'psychological stress responses', 'likelihood of cortisol stress reactions']",[],"[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0016664', 'cui_str': 'Stress fracture'}]",,0.00992355,"As predicted, the likelihood of cortisol stress reactions was significantly higher in the social identity condition (25 %) as compared to the personal identity condition (7 %).","[{'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Schury', 'Affiliation': 'Justus-Liebig-University Giessen, Germany. Electronic address: Valerie.A.Schury@psychol.uni-giessen.de.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'University of Vienna, Austria.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Häusser', 'Affiliation': 'Justus-Liebig-University Giessen, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104896']
1444,33096028,Diagnostic value of parameters from a spot urine sample for renal potassium loss in hypokalemia.,"BACKGROUND


We assessed the value of 1) a spot urine test for diagnosing hypokalemia caused by renal potassium loss, and 2) actual 24-hour urine potassium excretion (24 hUK-actual) for diagnosing hypokalemia caused by renal potassium loss in patients treated with potassium supplementation. The study population was from Southwest China.
METHODS


Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n = 67) and hypokalemia caused by extrarenal potassium loss (n = 63). Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated) were derived from spot urine samples collected on admission, before initiation of therapy. Patients received intravenous potassium chloride 0.4 or 0.6 g/h. 24 hUK-actual was detected in patients whose serum potassium did not return to normal after 24 h of therapy.
RESULTS


Patients with hypokalemia caused by renal potassium loss had significantly higher UK, UK/UCr, FEK, TTKG and 24 hUK-calculated compared to patients with hypokalemia caused by extrarenal potassium loss (P < 0.05). FEK predicted renal potassium loss in hypokalemia with high accuracy at a cut-off of 9.29% (sensitivity, 80.6%; specificity, 85.7%). The area under the curve for 24 hUK-actual in predicting renal potassium loss in patients with hypokalemia treated with low or high-dose potassium chloride infusion were 0.939 or 0.956, respectively. On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r = 0.831, p < 0.001 or r = 0.764, p < 0.001).
CONCLUSIONS


FEK from a spot urine sample represents a convenient and reliable parameter to predict renal potassium loss in patients with hypokalemia.",2020,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","['Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n=67) and hypokalemia caused by extrarenal potassium loss (n=63', 'hypokalemia', 'The study population was from Southwest China', 'patients with hypokalemia', 'patients with hypokalemia treated with low or high-dose']","['potassium chloride infusion', 'intravenous potassium chloride', 'potassium supplementation']","['renal potassium loss', 'Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0360652', 'cui_str': 'Potassium-containing product in parenteral dose form'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0202195', 'cui_str': 'Potassium measurement, urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.0248461,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China. Electronic address: lijia0876@126.com.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.10.024']
1445,33096120,"The impact of red grape juice (Vitis labrusca)consumption associated with physical training on oxidative stress, inflammatory and epigenetic modulation in healthy elderly women.","The imbalance of epigenetic, oxidative stress and inflammatory markers is associated with the aging physiopathology. Then, the influence of bioactive nutritional compounds and physical training on these biomarkers has been studied, although the combination of both strategies has been not investigated. Therefore, our aim was to verify the effect of the association of physical training with red grape juice (Vitis labrusca) consumption on global histone acetylation H3 and H4 levels, oxidative stress markers and interleukin 6 (IL-6) levels in peripheral blood of healthy elderly women. This double-blind randomized clinical study consisted of 29 volunteers, aged 59 years and over, divided into three groups: grape juice group (GJG, n = 9); placebo and exercise group (PLEG, n = 10) and grape juice and exercise group (GJEG, n = 10). During 1 month, GJG consumed 400 ml of grape juice per day (integral and conventional), while the PLEG and GJEG groups, besides consuming juice or placebo were submitted to a concurrent physical training protocol (two times per week, 60 min / session). The volunteers were submitted to blood collections before and after the intervention for the biomarkers analysis, e.g. IL-6, histone acetylation H3 and H4, lipid oxidative damage (TBARS), proteins (Carbonyl), non-enzymatic antioxidant defense (Sulfhydryl groups) and activity of antioxidant enzymes (superoxide dismutase and catalase). There were no statistically significant differences in the global levels of histone acetylation H3 and H4 post intervention compared to the basal period as well and between groups were found. However, PLEG and GJEG showed a remarkable reduction on IL-6 levels after intervention. We also observed an increase in Carbonyl levels, SOD activities and Sulfhydryl levels comparing before and after intervention. Considering the interaction of time and groups, a significant increase in Sulfhydryl levels only in GJG was found. The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women. However in grape juice group, without exercise, we observed an increase in non enzymatic antioxidant defense, what could be attributed to the polyphenols content. These responses seem not to be involved with histone acetylation status.",2020,The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women.,"['29 volunteers, aged 59 years', 'peripheral blood of healthy elderly women', 'elderly women', 'healthy elderly women']","['PLEG and GJEG', 'grape juice group (GJG, n\u202f=\u202f9); placebo and exercise group (PLEG, n\u202f=\u202f10) and grape juice and exercise group (GJEG, n\u202f=\u202f10', 'placebo', 'bioactive nutritional compounds and physical training', 'red grape juice (Vitis labrusca)consumption associated with physical training', 'physical training with red grape juice (Vitis labrusca) consumption']","['Sulfhydryl levels', 'global histone acetylation H3 and H4 levels, oxidative stress markers and interleukin 6 (IL-6) levels', 'Carbonyl levels, SOD activities and Sulfhydryl levels', 'oxidative stress, inflammatory and epigenetic modulation', 'non enzymatic antioxidant defense', 'global levels of histone acetylation H3', 'IL-6, histone acetylation H3 and H4, lipid oxidative damage (TBARS), proteins (Carbonyl), non-enzymatic antioxidant defense (Sulfhydryl groups) and activity of antioxidant enzymes (superoxide dismutase and catalase', 'IL-6 levels']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019652', 'cui_str': 'Histone'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}]",29.0,0.0363038,The physical training protocol associated or not with grape juice consumption showed anti-inflammatory effects and an influence in the antioxidant defenses (non enzymatic and enzymatic) in elderly women.,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil. Electronic address: carolinedani@yahoo.com.br.'}, {'ForeName': 'Karen Moura', 'Initials': 'KM', 'LastName': 'Dias', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Lucieli', 'Initials': 'L', 'LastName': 'Trevizol', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bassôa', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Iasmin', 'Initials': 'I', 'LastName': 'Fraga', 'Affiliation': 'Programa de Pós Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Isabel Cristina Teixeira', 'Initials': 'ICT', 'LastName': 'Proença', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Viviane Rostirola', 'Initials': 'VR', 'LastName': 'Elsner', 'Affiliation': 'Programa de Pós Graduação em Biociências e Reabilitação do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil; Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS, Brasil; Programa de Pós Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113215']
1446,33096517,Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial.,"STUDY OBJECTIVE


Spinal fusion surgery is associated with severe postoperative pain. We examined whether bilateral ultrasound-guided erector spinae plane block could alleviate postoperative pain in patients undergoing lumbar spinal fusion.
DESIGN


Blinded, randomized, controlled study.
SETTING


Tertiary university hospital, operating room, postoperative recovery room and ward.
PATIENTS


Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery were randomized into the erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio.
INTERVENTIONS


Pre-operative ultrasound-guided bilateral erector spinae plane block was performed in the ESPB group, while sham subcutaneous infiltration was performed in the control group.
MEASUREMENTS


The primary outcome was pain intensity at rest within 12 h postoperatively using the Numeric Rating Scale (NRS). Secondary outcomes included NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48 h after surgery.
MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023). The two groups showed similar pain scores at rest at 24 h after surgery (estimated mean difference - 0.2, 95% CI -0.8 to 0.5) and 48 h (-0.3, 95% CI -0.8 to 0.2). The ESPB group also showed significantly lower pain score on movement at 4 h after surgery (-1.5, 95% CI -2.5 to -0.6). The ESPB group showed a significantly smaller proportion of patients requiring sufentanil within 12 h after surgery (p = 0.020), and the group consumed significantly less sufentanil during that period (p = 0.042).
CONCLUSIONS


Bilateral ultrasound-guided erector spinae plane block improves postoperative analgesia in patients undergoing lumbar spinal fusion.",2020,"MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","['Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery', 'patients undergoing lumbar spinal fusion', 'Tertiary university hospital, operating room, postoperative recovery room and ward']","['sufentanil', 'bilateral ultrasound-guided erector spinae plane block', 'Pre-operative ultrasound-guided bilateral erector spinae plane block', 'erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio', 'ESPB', 'Bilateral ultrasound-guided erector spinae plane block']","['postoperative analgesia', 'pain intensity at rest within 12\xa0h postoperatively using the Numeric Rating Scale (NRS', 'smaller proportion of patients requiring sufentanil', 'pain score', 'pain scores', 'similar pain scores', 'NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.356452,"MAIN RESULTS


The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xizhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China. Electronic address: yifeng_65@163.com.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110090']
1447,33096557,An Expression of Concern from The Journal of Nutrition's Editorial Office about: High-dose ω-3 Fatty Acid Plus Vitamin D3 Supplementation Affects Clinical Symptoms and Metabolic Status of Patients with Multiple Sclerosis: A Randomized Controlled Clinical Trial.,,2020,,['Patients with Multiple Sclerosis'],['ω-3 Fatty Acid Plus Vitamin D3'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",[],,0.0930488,,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afarini', 'Affiliation': ''}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Abolhassani', 'Affiliation': ''}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': ''}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': ''}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Masoud', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa342']
1448,33098470,Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis.,"AIMS


This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA 2 DS 2 -VASc score parameters as predictors for clinical outcome.
METHODS


Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y 12  inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y 12  inhibitor and aspirin (100 mg OD, for 1-12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis.
RESULTS


Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654-1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711-1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA 2 DS 2 -VASc score was associated with increased rates of all outcomes. CHA 2 DS 2 -VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024).
CONCLUSION


After PCI in AF patients, increasing CHA 2 DS 2 -VASc score was associated with increased bleeding rates and CHA 2 DS 2 -VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.",2020,"Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024).
","['atrial fibrillation patients following successful coronary stenting', 'AF patients', 'Patients']","['mg once daily [OD]; n\u2009=\u2009751) plus a P2Y 12  inhibitor for 12\xa0months or a vitamin K antagonist [VKA] (n\u2009=\u2009755) plus a P2Y 12  inhibitor and aspirin', 'percutaneous coronary intervention (PCI) to either edoxaban', 'edoxaban']","['Major/CRNM bleeding event rates', 'composite of major/clinically relevant non-major bleeding (CRNM', 'bleeding rates and CHA 2 DS 2 -VASc score', 'CHA 2 DS 2 -VASc', 'overall net clinical benefit', 'Paroxysmal AF', 'cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis', 'event rates of composite outcome', 'occurrence of stent thrombosis', 'CHA 2 DS 2 -VASc score']","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.313531,"Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024).
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goette', 'Affiliation': 'Medizinische Klinik II: Kardiologie Und Intensivmedizin, St. Vincenz-Krankenhaus, Am Busdorf 2, 33098, Paderborn, Germany. andreas.goette@vincenz.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eckardt', 'Affiliation': 'Atrial Fibrillation Network, Munster, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Lewalter', 'Affiliation': 'Atrial Fibrillation Network, Munster, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Laeis', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zierhut', 'Affiliation': 'Daiichi Sankyo Europe, Munich, Germany.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Intensive Care, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01760-4']
1449,33099054,"A randomised controlled trial of metacognitive training for psychosis, depression, and belief flexibility.","BACKGROUND


Metacognitive training (MCT) has been shown to be effective in reducing psychotic symptoms, including delusions. However, less is known on whether MCT, or its specific modules, are effective in ameliorating reasoning biases e.g. belief flexibility. As inflexibility in appraisal has been associated with psychosis and major depressive disorder (MDD), this study examined the efficacy of a 4-session MCT on delusions, depression, and belief flexibility, in two clinical groups (Psychosis and Depression).
METHODS


This study adopted a single-blind randomised controlled design, with patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition. The MCT intervention consisted of specific modules targeting belief flexibility. Participants were assessed before and after treatment, and at 1- and 6-month follow-ups.
RESULTS


Among the 113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT. There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group. Symptom improvements following MCT were of large effect sizes, were significantly greater than TAU, and persisted at 6-month. Belief flexibility also improved in both groups, although changes were smaller in size and were not significantly greater than TAU.
LIMITATIONS


An active control condition was not included.
CONCLUSIONS


This study demonstrated large and stable symptom reductions in delusions and depression, and smaller (yet stable) improvement in belief flexibility across groups, following a 4-session MCT, carrying implications for transdiagnostic process-based interventions and their mechanisms of change.",2020,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","['patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition', '113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT']","['MCT', 'Metacognitive training (MCT', 'metacognitive training']","['Belief flexibility', 'depressive symptoms', 'psychotic symptoms, especially delusions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]",27.0,0.0534335,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ho-Wai So', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR. Electronic address: shwso@psy.cuhk.edu.hk.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Hoi-Kei Chan', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Cheris', 'Initials': 'C', 'LastName': 'Kit-Wa Wong', 'Affiliation': 'Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Wing-Ka Ching', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sze-Wai Lee', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chi-Wing Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kin-Hei Chung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Alyse Yu', 'Initials': 'AY', 'LastName': 'Hung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Oi-Yin Wong', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sau-Man Chan', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.126']
1450,33099083,Selfhood triumvirate: From phenomenology to brain activity and back again.,"Recently, a three-dimensional construct model for complex experiential Selfhood has been proposed (Fingelkurts, Fingelkurts, & Kallio-Tamminen, 2016b,c). According to this model, three specific subnets (or modules) of the brain self-referential network (SRN) are responsible for the manifestation of three aspects/features of the subjective sense of Selfhood. Follow up multiple studies established a tight relation between alterations in the functional integrity of the triad of SRN modules and related to them three aspects/features of the sense of self; however, the causality of this relation is yet to be shown. In this article we approached the question of causality by exploring functional integrity within the three SRN modules that are thought to underlie the three phenomenal components of Selfhood while these components were manipulated mentally by experienced meditators in a controlled and independent manner. Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG). This EEG-data was complemented by first-person phenomenological reports and standardised questionnaires which focused on subjective contents of three aspects of Selfhood. The results of the study strengthen the case for a direct causative relationship between three phenomenological aspects of Selfhood and related to them three modules of the brain SRN. Furthermore, the putative integrative model of the dynamic interrelations among three modules of the SRN has been proposed.",2020,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).",[],"['mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG']",[],[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",[],,0.0183146,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).","[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland. Electronic address: andrew.fingelkurts@bm-science.com.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Kallio-Tamminen', 'Affiliation': 'Physics Foundations Society and Society for Natural Philosophy, Helsinki, Finland.'}]",Consciousness and cognition,['10.1016/j.concog.2020.103031']
1451,33099092,Back foot influence on dorsiflexion using three different positions of the weight bearing lunge test.,"OBJECTIVES


To determine whether back foot (BF) position influences dorsiflexion range of motion (DFROM) during three different positions of the weight bearing lunge test (WBLT).
DESIGN


Randomised, repeated measures design.
SETTING


Sports clubs.
PARTICIPANTS


52 athletes participating in cutting and pivoting sports.
MAIN OUTCOME MEASURES


DFROM was obtained using a WBLT in three different BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB). All measurements were obtained using three methods: inclinometer at the tibial tuberosity, toe to wall distance and goniometer angle from the lateral malleolus to the fibula head. Differences between testing positions were determined using a repeated measures one-way ANOVA and reliability analysis was performed using the Intraclass Correlation Coefficient (ICC).
RESULTS


DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001). These results were associated with large effect sizes for all BF positions and measurement techniques. Reliability ICC values were excellent for all measurements (ICC 0.94-0.99).
CONCLUSIONS


Results show that DFROM differs depending upon the position of the BF during the WBLT. Further research is needed to establish the reproducibility of these three BF positions due to the variability observed.",2020,"RESULTS


DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","['Sports clubs', '52 athletes participating in cutting and pivoting sports']",[],"['BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB', 'DFROM', 'back foot (BF) position influences dorsiflexion range of motion (DFROM', 'Reliability ICC values']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]",[],"[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",52.0,0.0302354,"RESULTS


DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cady', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK; School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK. Electronic address: k.cady2@herts.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Ste Croix', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deighan', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.005']
1452,33099189,Do the metrics matter? An experimental investigation of Instagram influencer effects on mood and body dissatisfaction.,"Instagram is saturated with content from 'influencers', users who create high-quality idealised content, attain celebrity-level following, and often leverage their popularity to earn money through brand partnership/promotion. Although existing literature generally indicates the negative impact of idealised Instagram imagery on female psychological wellbeing, influencer imagery has yet to receive thorough attention. We investigated the impact of high versus low popularity influencer images on mood and body dissatisfaction. Adult women (N = 111, aged 17-40) were randomly allocated to one of three groups: either (1) the influencer-high group (idealised imagery alongside high 'like'/follow metrics); (2) the influencer-low group (the same idealised imagery adjusted for low popularity metrics); or (3) a nature control group with matched low-popularity metrics. Results revealed significantly higher negative mood and body dissatisfaction within the two influencer imagery groups compared with the control group. Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction. The findings suggest that users should be aware of the potentially negative impacts of viewing idealised influencer imagery, regardless of whether the content is high or low in popularity.",2020,"Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction.","['Adult women (N = 111, aged 17-40']","[""influencer-high group (idealised imagery alongside high 'like'/follow metrics); (2) the influencer-low group (the same idealised imagery adjusted for low popularity metrics); or (3) a nature control group with matched low-popularity metrics""]","['negative mood and body dissatisfaction', 'mood and body dissatisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",111.0,0.0293242,"Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lowe-Calverley', 'Affiliation': 'University of Tasmania, Australia. Electronic address: Emily.Lowe@utas.edu.au.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'University of Tasmania, Australia. Electronic address: Rachel.Grieve@utas.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.10.003']
1453,33099227,Effect of growth hormone treatment on circulating levels of NT-proBNP in patients with ischemic heart failure.,"AIMS


Growth hormone (GH) therapy in heart failure (HF) is controversial. We investigated the cardiovascular effects of GH in patients with chronic HF due to ischemic heart disease.
METHODS


In a double-blind, placebo-controlled trial, we randomly assigned 37 patients (mean age 66 years; 95% male) with ischemic HF (ejection fraction [EF] < 40%) to a 9-month treatment with either recombinant human GH (1.4 mg every other day) or placebo, with subsequent 3-month treatment-free follow-up. The primary outcome was change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR). Secondary outcomes comprised changes in cardiac structure and EF. Prespecified tertiary outcomes included changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP).
RESULTS


No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class. In the GH group, circulating levels of IGF-1 doubled from baseline (+105%; p < 0.001) and NT-proBNP levels halved (-48%; p < 0.001) during the treatment period, with subsequently a partial return of both towards baseline levels. No changes in IGF-1 or NT-proBNP were observed in the placebo group at any time during the study.
CONCLUSION


In patients with chronic ischemic HF, nine months of GH treatment was associated with significant increases in levels of IGF-1 and reductions in levels of NT-proBNP, but did not affect cardiac structure, systolic function or functional capacity.",2020,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"['patients with chronic HF due to ischemic heart disease', 'heart failure (HF', 'patients with ischemic heart failure', '37 patients (mean age 66\xa0years; 95% male) with ischemic HF']","['growth hormone treatment', 'GH', 'recombinant human GH', 'placebo', 'Growth hormone (GH) therapy']","['circulating levels of IGF-1', 'circulating levels of NT-proBNP', 'changes in cardiac structure and EF', 'changes in New York Heat Association (NYHA) functional class and quality of life (QoL), as well as levels of insulin-like growth factor-1 (IGF-1) and N-terminal pro-brain natriuretic peptide (NT-proBNP', 'IGF-1 or NT-proBNP', 'NT-proBNP levels', 'change in left ventricular (LV) end-systolic volume measured by cardiac magnetic resonance (CMR', 'cardiac structure or systolic function', 'cardiac structure, systolic function or functional capacity', 'levels of IGF-1 and reductions in levels of NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",37.0,0.265861,No changes in cardiac structure or systolic function were identified in either treatment group; nor did GH treatment affect QoL or functional class.,"[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. Electronic address: kristjan.karason@gu.se.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bobbio', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Polte', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Departments of Clinical Physiology and Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Entela', 'Initials': 'E', 'LastName': 'Bollano', 'Affiliation': 'Departments of Cardiology and Transplantation, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cittadini', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Caidahl', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institute (KI), Stockholm, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Hjalmarson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt-Åke', 'Initials': 'BÅ', 'LastName': 'Bengtsson', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ekelund', 'Affiliation': 'Centre of Registers Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Jörgen', 'Initials': 'J', 'LastName': 'Isgaard', 'Affiliation': 'Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101359']
1454,33102346,Maternal health-related barriers and the potentials of mobile health technologies: Qualitative findings from a pilot randomized controlled trial in rural Southwestern Uganda.,"Background


Maternal mortality rate remains unacceptably high in Uganda. In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking. The potentials of mobile health technologies in addressing the maternal health challenges remain unclear.
Aim


To explore the maternal health-related barriers among illiterate pregnant women in rural Southwestern Uganda and highlight the potentials of mobile health technologies.
Material and Methods


This is a midline qualitative study conducted with the participants of a pilot randomized controlled trial. Between October 2019 and December 2019, we carried out semi-structured interviews with 30 illiterate pregnant mothers. Interviews elicited information on the barriers to access and utilization of maternal health services. An inductive, content analytic approach was used to analyze qualitative data. Quantitative sociodemographic and socioeconomic data were summarized descriptively.
Results


Participants reported that lack of money (for transport and medical costs), unfriendly maternal health services, and delays at the maternal health clinic constrain access and utilization of maternal health services. Given their widespread adoption, mobile technologies can potentially address some of these barriers e.g., money for transport or microenterprise start-up can be sent to women through their mobile phones or maternal health-related services (such as health education and consultation) can be provided electronically.
Conclusion


Future efforts should focus on utilizing mobile health technologies to not only enable women overcome the critical financial challenges but also facilitate remote access and utilization of maternal health services.",2020,In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking.,"['rural illiterate pregnant women', 'illiterate pregnant women in rural Southwestern Uganda', 'rural Southwestern Uganda', 'Between October 2019 and December 2019, we carried out semi-structured interviews with 30 illiterate pregnant mothers']",[],"['lack of money (for transport and medical costs), unfriendly maternal health services, and delays at the maternal health clinic constrain access and utilization of maternal health services']","[{'cui': 'C0020899', 'cui_str': 'Illiteracy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",[],"[{'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0024922', 'cui_str': 'Health Services, Maternal'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0762542,In-depth evidence about the barriers to access and utilization of maternal health services specifically among the rural illiterate pregnant women remains lacking.,"[{'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Tumuhimbise', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Esther C', 'Initials': 'EC', 'LastName': 'Atukunda', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Sandrah', 'Initials': 'S', 'LastName': 'Ayebaza', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Katusiime', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Mugyenyi', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Pinkwart', 'Affiliation': 'Humbold t-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Angella', 'Initials': 'A', 'LastName': 'Musiimenta', 'Affiliation': 'Mbarara University of Science and Technology, Mbarara, Uganda.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_281_20']
1455,33111337,Pharmacodynamics and pharmacokinetics of DWP14012 (fexuprazan) in healthy subjects with different ethnicities.,"BACKGROUND


DWP14012 (fexuprazan), a novel potassium-competitive acid blocker, is under development for the treatment of acid-related disorders.
AIMS


To compare the pharmacodynamics (PDs), pharmacokinetics (PKs) and safety of DWP14012 among healthy subjects of Korean, Caucasian and Japanese descent.
METHODS


A randomised, double-blind, placebo-controlled, single- and multiple-dose study was conducted. Ten subjects in each dose group (40, 60 or 80 mg for Koreans; 40 or 80 mg for Caucasians; 20, 40 or 80 mg for Japanese) were randomly assigned to DWP14012 or a placebo. Twenty-four-hour intragastric pH measurements and serial blood samples were collected for PK/PD evaluation. The PK/PD parameters were compared between each ethnicity.
RESULTS


The extent of gastric acid suppression was similar among the ethnicities; the mean percentages of time that the intragastric pH was above 4 after multiple doses of 40 mg in the Korean, Caucasian and Japanese subjects were 64.3%, 62.8% and 70.3%, respectively, and the corresponding values for the 80 mg dose were 94.8%, 90.6% and 90.6% respectively. The changes in serum gastrin were not clinically significant between all three ethnicities. The systemic exposure of DWP14012 was similar between the three ethnicities after the 40 mg doses but slightly lower in Caucasian and Japanese subjects after the 80 mg doses. Gastric acid suppression by DWP14012 showed a clear exposure-response relationship in the three ethnicities.
CONCLUSIONS


Gastric acid suppression by DWP14012 was similar among the Korean, Caucasian and Japanese subjects in this study, and the PK, PK-PD relationships and safety were also similar among the three ethnicities. DWP14012 could be used without consideration of ethnicity.",2020,The systemic exposure of DWP14012 was similar between the three ethnicities after the 40 mg doses but slightly lower in Caucasian and Japanese subjects after the 80 mg doses.,"['healthy subjects with different ethnicities', 'healthy subjects of Korean, Caucasian and Japanese descent', 'Ten subjects in each dose group (40, 60 or 80\xa0mg for Koreans; 40 or 80\xa0mg for Caucasians; 20, 40 or 80\xa0mg for Japanese']","['placebo', 'DWP14012 (fexuprazan']","['serum gastrin', 'pharmacodynamics (PDs), pharmacokinetics (PKs) and safety of DWP14012', 'systemic exposure of DWP14012', 'Gastric acid suppression', 'gastric acid suppression']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0017119', 'cui_str': 'Gastric acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.0767119,The systemic exposure of DWP14012 was similar between the three ethnicities after the 40 mg doses but slightly lower in Caucasian and Japanese subjects after the 80 mg doses.,"[{'ForeName': 'Jun Gi', 'Initials': 'JG', 'LastName': 'Hwang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Inseung', 'Initials': 'I', 'LastName': 'Jeon', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Ae', 'Initials': 'SA', 'LastName': 'Park', 'Affiliation': 'Daewoong Pharmaceutical Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Areum', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Daewoong Pharmaceutical Co., Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16131']
1456,33108379,Improved nutrition in early life and pulse wave velocity and augmentation index in mid-adulthood: Follow-up of the INCAP Nutrition Supplementation Trial Longitudinal Study.,"Nutrition in pregnancy and early childhood affects later blood pressure and precursors of atherosclerosis, but its influence on arterial stiffness is unexplored. This study determines whether exposure to improved nutrition during early life influences Augmentation index (AI) and pulse wave velocity (PWV) in mid-adulthood. We included 1221 adults (37-54y) who participated in a cluster-randomized nutritional supplementation trial of a protein-energy beverage (Atole), conducted between 1969-1977 in Guatemala. The comparison group received Fresco, a low-calorie protein-free beverage. In 2015-17, we measured anthropometry (weight, height, and waist-to-height ratio); AI and PWV (using carotid-femoral tonometry); blood pressure; fasting plasma glucose and serum lipids; and sociodemographic characteristics. Based on patterns of exposure, we characterized participants as fully, partially or unexposed to the intervention from conception to their second birthday (the 'first 1000 days'). We fit pooled and sex-specific models using intention-to-treat, difference-in-difference regression analysis to test whether exposure to the supplement in the first 1000 days was associated with AI and PWV in adulthood adjusting for basal and current sociodemographic variables and current life-style and cardio-metabolic risk factors. Prevalence of obesity in men and women was 39.6% and 19.6%, and prevalence of hypertension was 44.0% and 36.0%, respectively. Women had higher AI (34.4±9.6%) compared to men (23.0± 9.8%), but had similar PWV (7.60±1.13 m/s and 7.60±1.31, respectively). AI did not differ significantly across intervention groups. PWV was lower in individuals with full exposure to the supplement during the first 1000 days (-0.39m/s, 95% CI -0.87, 0.09; p = 0.1) compared to unexposed individuals. This difference was similar after adjusting for cardio-metabolic risk factors (-0.45m/s; 95%C-0.93, 0.01; p = 0.06). Exposure to improved nutrition during the first 1000 days was marginally associated with lower PWV, but not with AI.",2020,"PWV was lower in individuals with full exposure to the supplement during the first 1000 days (-0.39m/s, 95% CI -0.87, 0.09; p = 0.1) compared to unexposed individuals.","['mid-adulthood', '1221 adults (37-54y) who participated in a cluster-randomized nutritional supplementation trial of a protein-energy beverage (Atole), conducted between 1969-1977 in Guatemala']","['Fresco, a low-calorie protein-free beverage']","['Improved nutrition in early life and pulse wave velocity and augmentation index', 'Prevalence of obesity', 'cardio-metabolic risk factors', 'anthropometry (weight, height, and waist-to-height ratio); AI and PWV (using carotid-femoral tonometry); blood pressure; fasting plasma glucose and serum lipids; and sociodemographic characteristics', 'Augmentation index (AI) and pulse wave velocity (PWV', 'prevalence of hypertension', 'PWV']","[{'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1221.0,0.0587138,"PWV was lower in individuals with full exposure to the supplement during the first 1000 days (-0.39m/s, 95% CI -0.87, 0.09; p = 0.1) compared to unexposed individuals.","[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Kroker-Lobos', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Ford', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Gonzalez-Casanova', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, Georgia, United States of America.'}]",PloS one,['10.1371/journal.pone.0239921']
1457,33120238,Classification of renal tumour using convolutional neural networks to detect oncocytoma.,"PURPOSE


To investigate the ability of convolutional neural networks (CNNs) to facilitate differentiation of oncocytoma from renal cell carcinoma (RCC) using non-invasive imaging technology.
METHODS


Data were collected from 369 patients between January 2015 and September 2018. True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy. The data included 20,000 2D CT images. Data were randomly divided into sets for training (70 %), validation (10 %) and independent testing (20 %, DataTest_1). A small dataset (DataTest_2) was used for additional validation of the training model. Data were divided into sets at the patient level, rather than by individual image. A modified version of the ResNet50V2 was used. Accuracy of detecting benign or malignant renal mass was evaluated by a 51 % majority vote of individual image classifications to determine the classification for each patient.
RESULTS


Test results from DataTest_1 indicate an area under the curve (AUC) of 0.973 with 93.3 % accuracy and 93.5 % specificity. Results from DataTest_2 indicate an AUC of 0.946 with 90.0 % accuracy and 98.0 % specificity when evaluation is performed image by image. There is no case in which multiple false negative images originate from the same patient. When evaluated with 51 % majority of scans for each patient, the accuracy rises to 100 % and the incidence of false negatives falls to zero.
CONCLUSION


CNNs and deep learning technology can classify renal tumour masses as oncocytoma with high accuracy. This diagnostic method could prevent overtreatment for patients with renal masses.",2020,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"['Data were collected from 369 patients between January 2015 and September 2018', 'patients with renal masses']","['convolutional neural networks (CNNs', 'CNNs and deep learning technology']","['Accuracy of detecting benign or malignant renal mass', 'accuracy rises', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",369.0,0.020162,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: mikkped@ruc.dk.'}, {'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Herlev-Gentofte University Hospital, Herlev Ringvej 75, 2700, Herlev, Denmark. Electronic address: michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: henning@ruc.dk.'}, {'ForeName': 'Nessn H', 'Initials': 'NH', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Department of Clinical Medicine, Copenhagen University, Sygehusvej 10, 4000, Roskilde, Denmark. Electronic address: nesa@regionsjaelland.dk.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109343']
1458,33120301,"Analgesic efficacy of ketamine and magnesium after laparoscopic sleeve gastrectomy: A randomized, double-blind, placebo-controlled trial.","Background Ketamine and magnesium are antagonists of the N-methyl-d-aspartate receptor, and are valuable adjuvants for multimodal analgesia and opioid sparing. Data are limited regarding the opioid sparing efficacy of the combined intraoperative application of these agents in laparoscopic bariatric surgery. The objective of this study was to compare the postoperative opioid sparing properties of a single intraoperative dose of ketamine versus a combination of single doses of ketamine and magnesium after laparoscopic gastric sleeve resection in bariatric patients. Methods One hundred and twenty- six patients were randomly assigned to receive single boluses of ketamine alone 0.5 mg kg -1  IV (ketamine group); combined ketamine bolus of 0.5 mg kg -1  IV and magnesium 2 g IV (ketamine and magnesium group); or placebo. Opioid consumption at 24 h (in morphine equivalents); pain at rest; postoperative nausea and vomiting impact score; sedation scores; and trends of transcutaneous carbon-di-oxide values were analysed. Results The median (inter-quartile range [range]) morphine consumption at 24 h were 32 (24-47 [4.8-91]) mg in the ketamine group, 37 (18-53 [1-144]) mg in the ketamine and magnesium group, and 26 (21-36 [5-89]) mg in the control group and were not significantly different between the groups. There were no differences for all other outcomes examined. Conclusion Combined single intraoperative bolus doses of ketamine and magnesium did not result in postoperative opioid sparing after laparoscopic gastric sleeve resection.",2020,morphine consumption at 24 h were 32,"['after laparoscopic gastric sleeve resection', 'bariatric patients', 'Methods One hundred and twenty- six patients', 'after laparoscopic sleeve gastrectomy', 'consumption at 24\xa0h were 32']","[' Ketamine and magnesium', 'laparoscopic gastric sleeve resection', 'ketamine', 'ketamine alone 0.5\xa0mg\xa0kg -1  IV (ketamine group); combined ketamine bolus of 0.5\xa0mg\xa0kg -1  IV and magnesium 2\xa0g IV (ketamine and magnesium group); or placebo', 'placebo', 'ketamine and magnesium', 'morphine']","['Opioid consumption', 'nausea and vomiting impact score; sedation scores', 'transcutaneous carbon-di-oxide values', 'Analgesic efficacy', 'postoperative opioid sparing']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}]",126.0,0.636448,morphine consumption at 24 h were 32,"[{'ForeName': 'Sanjib Das', 'Initials': 'SD', 'LastName': 'Adhikary', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America. Electronic address: sadhikary@pennstatehealth.psu.edu.'}, {'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Thiruvenkatarajan', 'Affiliation': 'The Queen Elizabeth Hospital, Department of Anaesthesia, The University of Adelaide, Woodville South, SA 5011, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McFadden', 'Affiliation': 'St. Claire Hospital, Department of Anesthesiology, 1000 Bower Hill Rd, Pittsburgh, PA 15243, United States of America.'}, {'ForeName': 'Wai Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Research School of Finance, Actuarial Studies and Statistics, Australian National University, Canberra ACT 0200, Australian Capital Territory, Australia.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Mets', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Penn State Hershey Medical Center, Surgical Weight Loss Program, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110097']
1459,33120302,Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial.,"STUDY OBJECTIVE


Delirium is frequently observed in the postoperative and intensive care unit (ICU) population. Due to the multifactorial origin of delirium and according to international guidelines (e.g., American Geriatrics Society; Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) guideline), there are several but no incontestable options for prevention and symptomatic treatment. The purpose of the Baden PRIDe (Prevention and Reduction of Incidence of postoperative Delirium) trial was to determine whether postoperative cognitive dysfunction and delirium could be prevented by the combination of possible preventive agents such as haloperidol and ketamine. In addition, pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β were measured to investigate their dynamics in delirious and non-delirious patients after surgery.
DESIGN


The Baden PRIDe Trial was an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial.
SETTING


Perioperative care.
PATIENTS


182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia.
INTERVENTIONS


Pre-anaesthetic, pharmacologic prevention of postoperative brain dysfunction with haloperidol, ketamine, and the combination of both vs. placebo.
MEASUREMENTS


Assessment of cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay.
MAIN RESULTS


None of the three study arms - haloperidol, ketamine, or both drugs combined - was significantly superior to placebo for prevention of postoperative brain dysfunction and delirium (P = 0.39). Measured levels of postoperative cortisol were significantly higher in delirious patients. S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
CONCLUSIONS


The study results offer no possibility for a novel recommendation for prevention of postoperative cognitive decline including delirium. Perioperative S-100β trajectories in patients with cognitive deterioration suggest affection of glial cells in particular.
TRIAL REGISTRATION


ClinicalTrials.govNCT02433041; registered on April 7, 2015.",2020,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","['patients with cognitive deterioration suggest affection of glial cells in particular', '182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia']","['haloperidol, ketamine', 'Ketamine vs. haloperidol', 'haloperidol and ketamine', 'placebo', 'haloperidol, ketamine, and the combination of both vs. placebo']","['pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β', 'cognitive dysfunction and postoperative delirium', 'postoperative NSE levels', 'cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay', 'Measured levels of postoperative cortisol', 'S-100β levels', 'postoperative brain dysfunction and delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",182.0,0.394449,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Alexa.Hollinger@usb.ch.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Rüst', 'Affiliation': 'Institute of Primary Care, University of Zurich, Pestalozzistrasse 24, 8091 Zurich, Switzerland. Electronic address: christoph.ruest@bluewin.ch.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Riegger', 'Affiliation': 'Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: HarrietYvonne.Riegger@usb.ch.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gysi', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: bianca.gysi@stud.unibas.ch.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tran', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: fabian.tran@stud.unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Brügger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jonas.bruegger@stud.unibas.ch.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jan.huber@vtxmail.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Toft', 'Affiliation': 'Department for Anaesthesia, Intensive Care and Emergency Medicine, See-Spital, Horgen and Kilchberg Branches, Asylstrasse 19, 8810 Horgen, Switzerland. Electronic address: Katharina.Toft@gmail.com.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Surbeck', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: madlen.surbeck@stud.unibas.ch.'}, {'ForeName': 'Hans-Ruedi', 'Initials': 'HR', 'LastName': 'Schmid', 'Affiliation': 'Central Laboratory, Cantonal Hospital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: Hans-Ruedi.Schmid@ksb.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department of Clinical Chemistry and Laboratory Medicine, Petersgraben 4, 4031 Basel, Switzerland. Electronic address: Katharina.Rentsch@usb.ch.'}, {'ForeName': 'Luzius', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: Luzius.Steiner@usb.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Martin.Siegemund@usb.ch.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110099']
1460,33123819,The effects of caffeine on olfactory function and mood: an exploratory study.,"Caffeine has been demonstrated to enhance olfactory function in rodents, but to date, the sparse research in humans has not shown any equivalent effects. However, due to the methodological nature of those human studies, a number of questions remain unanswered, which the present study aimed to investigate. Using a double-blind experimental design, participants (n = 40) completed baseline mood measures, standardised threshold and identification tests and were then randomly allocated to receive a capsule containing either 100 mg of caffeine or placebo, followed by the same olfactory tests and mood measures. Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function. In contrast, for non-caffeine consumers, caffeine acted to enhance odour (threshold) sensitivity but reduce odour identification. Overall, these findings demonstrate a complex profile of effects of caffeine on odour function and, given the evidence from the wider caffeine literature, it is proposed that the effects of caffeine might be limited to older populations.",2020,"Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function.","['participants (n = 40) completed baseline mood measures, standardised threshold and identification tests']","['capsule containing either 100 mg of caffeine or placebo', 'caffeine', 'Caffeine']","['odour function', 'olfactory function and mood']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0748987,"Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function.","[{'ForeName': 'Lorenzo D', 'Initials': 'LD', 'LastName': 'Stafford', 'Affiliation': 'Department of Psychology, University of Portsmouth, King Henry Building, King Henry I Street, Portsmouth, PO1 2DY, UK. lorenzo.Stafford@port.ac.uk.'}, {'ForeName': 'Kaylee', 'Initials': 'K', 'LastName': 'Orgill', 'Affiliation': 'Department of Psychology, University of Portsmouth, King Henry Building, King Henry I Street, Portsmouth, PO1 2DY, UK.'}]",Psychopharmacology,['10.1007/s00213-020-05695-6']
1461,33125902,Postoperative hemorrhage following coblation tonsillectomy with and without suture: A randomized study in Chinese adults.,"PURPOSE


Coblation tonsillectomy (TE) increases gradually in China. Hemorrhage is the main complication after tonsillectomy. The conclusions of the studies about suture after tonsillectomy are conflicting. To compare the post-tonsillectomy hemorrhage (PTH) rates in patients who underwent coblation with vs. without suture.
MATERIALS AND METHODS


This was a randomized controlled study of adult patients who underwent coblation TE at our hospital between 01/2017 and 08/2019. The patients were randomized to TE with or without suture. The primary endpoint was the secondary PTH. The secondary endpoints included the primary PTH, grade of PTH, and incidence of PTH within 4 weeks post-TE.
RESULTS


There were no differences between the two groups regarding sex, age, disease course, and BMI (all P > 0.05). The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016). Compared with non-suture group, the incidence of PTH within 4 weeks (2.8% vs. 10.6%, P = 0.009) and the PTH degree (P = 0.02) were all significantly lower in the suture group.
CONCLUSION


Intraoperative suture reduces the secondary PTH in adult patients who underwent coblation tonsillectomy. The incidence of PTH within 4 weeks, PTH degree and pain might all improved for intraoperative suture.",2020,"The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016).","['Chinese adults', 'patients who underwent coblation with vs. without suture', 'adult patients who underwent coblation TE at our hospital between 01/2017 and 08/2019', 'adult patients who underwent coblation tonsillectomy']","['Coblation tonsillectomy (TE', 'TE with or without suture', 'coblation tonsillectomy with and without suture', 'Intraoperative suture']","['primary PTH, grade of PTH, and incidence of PTH within 4\xa0weeks post-TE', 'Postoperative hemorrhage', 'post-tonsillectomy hemorrhage (PTH) rates', 'incidence of PTH within 4\xa0weeks, PTH degree and pain', 'occurrence of secondary PTH', 'PTH degree', 'secondary PTH', 'incidence of PTH']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C1279603', 'cui_str': 'Primary post tonsillectomy hemorrhage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1279604', 'cui_str': 'Secondary post tonsillectomy hemorrhage'}]",,0.0848415,"The occurrence of secondary PTH was lower in the suture group compared with the non-suture group (2.8% vs. 7.7%, P = 0.016).","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology, ShenZhen People's Hospital, Shenzhen, Guangdong, China. Electronic address: 13923457897@139.com.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology, 8th Medical Center, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yanlu', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': ""Department of Otolaryngology, ShenZhen People's Hospital, Shenzhen, Guangdong, China.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102760']
1462,33125944,Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH).,"BACKGROUND


Based on the hypothesis of synergistic effect of avelumab with cetuximab and radiotherapy, this new combination is tested in a randomised trial against two well-established standard of care (SOC) in locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN).
METHODS


This phase III trial comprises two cohorts of patients deemed fit to receive cisplatin (100 mg/m 2  Q3W) (cohort 1) or unfit to cisplatin (cohort 2). The SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin in cohort 1 (arm A) and with weekly cetuximab in cohort 2 (arm D). In both cohorts, experimental arms (arms B and C) were IMRT with cetuximab and avelumab (10 mg/kg day 7 and every 2 weeks) followed by avelumab every two weeks for 12 months. A safety phase was planned among the first 41 patients in experimental arms by monitoring grade ≥IV adverse events (AEs) with an unacceptable rate of 35%.
RESULTS


Between September 2017 and August 2018, 82 patients with LA-SCCHN were randomised including 41 patients in experimental arms. All patients of experimental arms except one (arm C) received entire radiotherapy as planned. Most common grade ≥III AEs were mucositis, radio-dermatitis, and dysphagia. Grade ≥IV AEs occurred in 5/41 (12%) patients, all in arm C (no grade V). This rate was acceptable according to the hypotheses of the safety phase. In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


The avelumab-cetuximab-RT combination was tolerable for patients with LA-SCCHN, and the approval was given for continuing the trial without modification. CLINICALTRIAL.GOV: NCT02999087.",2020,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


","['locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN', 'Between September 2017 and August 2018, 82 patients with LA-SCCHN', 'locally advanced squamous-cell carcinoma of the head and neck']","['avelumab with cetuximab and radiotherapy', 'cisplatin', 'avelumab-cetuximab-RT combination', 'Avelumab-cetuximab-radiotherapy', 'SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin', 'unfit to cisplatin', 'IMRT with cetuximab and avelumab', 'entire radiotherapy']","['Grade ≥IV AEs', 'mucositis, radio-dermatitis, and dysphagia', 'grade ≥IV AEs', 'grade V haemorrhage']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",82.0,0.0711299,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION


","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Le Havre, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU, Amiens, France.'}, {'ForeName': 'Cedrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Liem', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': 'ICO Rene-Gauducheau, Nantes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Colin-Batailhou', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.008']
1463,33127585,"Prior Pain Exposure and Mere Possession of a Placebo Analgesic Predict Placebo Analgesia: Findings From a Randomized, Double-Blinded, Controlled Trial.","A recent study found that merely possessing a placebo analgesic reduces pain. The current study tested for a possible moderator of this effect. Specifically, does the mere possession of a placebo analgesic affect pain for individuals with and without immediate prior experience with the pain task? Healthy participants (N = 127) were randomized to prior pain (PP) condition or without prior pain (No-PP) condition. In the PP condition, participants first did a preliminary trial of a cold pressor test (CPT) to induce direct experience with this pain stimulus. Then they were randomized to possess an inert cream described as either an analgesic cream or an anti-itch cream (pain-irrelevant control object). Participants then completed the main CPT. In the No-PP condition, participants underwent identical procedures and randomization except that they did not do a preliminary CPT, thus having no immediate prior CPT pain experience. We found a significant prior pain experience and possession status interaction effect on placebo analgesia. Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream. Such mere possession effect was not found in the PP condition. The impact of expectancy and emotion on the underlying process are discussed. PERSPECTIVE: This article presents a novel finding that prior pain exposure and mere possession of a placebo analgesic predicted placebo analgesia. It offers a novel perspective on the time course of placebo effect. It provides practical implications on potential pain intervention for clinicians and paradigm design for researchers of placebo study.",2020,Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream.,['Healthy participants (N=127'],"['cold pressor test (CPT', 'placebo analgesic predicted placebo analgesia', 'prior pain (PP) condition or without prior pain (No-PP) condition', 'placebo analgesic', 'analgesic cream or an anti-itch cream (pain-irrelevant control object']","['lower pain', 'pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",127.0,0.337568,Participants in the No-PP condition showed evidence of lower pain when they merely possessed an analgesic cream than an anti-itch cream.,"[{'ForeName': 'Victoria Wai-Lan', 'Initials': 'VW', 'LastName': 'Yeung', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Hong Kong. Electronic address: vickiyeung@ln.edu.hk.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, Ohio.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.10.004']
1464,33096554,A Whole-Diet Approach Affects Not Only Fasting but Also Postprandial Cardiometabolic Risk Markers in Overweight and Obese Adults: A Randomized Controlled Trial.,"BACKGROUND


Current dietary recommendations for cardiovascular disease (CVD) prevention focus more on dietary patterns than on single nutrients. However, randomized controlled trials using whole-diet approaches to study effects on both fasting and postprandial CVD risk markers are limited.
OBJECTIVE


This randomized parallel trial compared the effects of a healthy diet (HD) with those of a typical Western diet (WD) on fasting and postprandial CVD risk markers in overweight and obese adults.
METHODS


After a 2-wk run-in period, 40 men and women (50-70 y; BMI: 25-35 kg/m2) consumed the HD (high in fruit and vegetables, pulses, fibers, nuts, fatty fish, polyunsaturated fatty acids; low in salt and high-glycemic carbohydrates; n = 19) or the WD (less fruit, vegetables, and fibers; no nuts and fatty fish; and more saturated fatty acids and simple carbohydrates; n = 21) for 6 wk. Fasting and postprandial cardiometabolic risk markers were assessed as secondary outcome parameters during a 5-h mixed-meal challenge, and a per protocol analysis was performed using 1-factor ANCOVA or linear mixed models.
RESULTS


Differences in diet-induced changes are expressed relative to the HD group. Changes in fasting plasma total cholesterol (-0.57 ± 0.12 mmol/L, P < 0.001), LDL cholesterol (-0.41 ± 0.12 mmol/L, P < 0.01), apolipoprotein B100 (-0.09 ± 0.03 g/L, P < 0.01), and apolipoprotein A1 (-0.06 ± 0.03 g/L, P = 0.05) were significantly different between the diet groups. Changes in postprandial plasma triacylglycerol (diet × time, P < 0.001) and apolipoprotein B48 (P < 0.01) differed significantly between the groups with clear improvements on the HD, although fasting triacylglycerols (-0.24 ± 0.13 mmol/L, P = 0.06) and apolipoprotein B48 (1.04 ± 0.67 mg/L, P = 0.40) did not. Significant differences between the diets were also detected in fasting systolic (-6.9 ± 3.1 mmHg, P < 0.05) and 24-h systolic (-5.0 ± 1.7 mmHg, P < 0.01) and diastolic (-3.3 ± 1.1 mmHg, P < 0.01) blood pressure.
CONCLUSION


A whole-diet approach targeted multiple fasting and postprandial CVD risk markers in overweight and obese adults. In fact, the postprandial measurements provided important additional information to estimate CVD risk. This trial is registered at clinicaltrials.gov as NCT02519127.",2020,"Changes in fasting plasma total cholesterol (-0.57 ± 0.12 mmol/L, P ","['40 men and women (50-70 y; BMI: 25-35 kg/m2', 'Overweight and Obese Adults', 'overweight and obese adults']","['consumed the HD (high in fruit and vegetables, pulses, fibers, nuts, fatty fish, polyunsaturated fatty acids; low in salt and high-glycemic carbohydrates; n\xa0=\xa019) or the WD (less fruit, vegetables, and fibers; no nuts and fatty fish; and more saturated fatty acids and simple carbohydrates', 'healthy diet (HD) with those of a typical Western diet (WD']","['fasting plasma total cholesterol', 'fasting and postprandial CVD risk markers', 'LDL cholesterol', 'blood pressure', '24-h systolic', 'apolipoprotein A1', 'apolipoprotein B48', 'apolipoprotein B100 (-0.09\xa0±', 'fasting triacylglycerols', 'fasting systolic', 'postprandial plasma triacylglycerol (diet × time, P', 'multiple fasting and postprandial CVD risk markers', 'Fasting and postprandial cardiometabolic risk markers', 'Postprandial Cardiometabolic Risk Markers']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3849996', 'cui_str': 'Western Diet'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0205666', 'cui_str': 'Apolipoprotein B-100'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",,0.0381722,"Changes in fasting plasma total cholesterol (-0.57 ± 0.12 mmol/L, P ","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fechner', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Bilet', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Harry P F', 'Initials': 'HPF', 'LastName': 'Peters', 'Affiliation': 'Unilever Food Innovation Center, Wageningen, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, Maastricht University Medical Center+, Maastricht, The Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxaa252']
1465,33096810,A High Protein Calorie Restriction Diet Alters the Gut Microbiome in Obesity.,"BACKGROUND


High protein calorie restriction diets have shown clinical efficacy for obesity, but the mechanisms are not fully known. The intestinal microbiome is a mediator of obesity and preclinical data support an effect of high protein diet (HPD) on the gut microbiome of obesity, but there are few studies in humans.
METHODS


To address this, we conducted a dietary intervention trial of 80 overweight and obese subjects who were randomized to a calorie-restricted high protein diet (HPD) (30% calorie intake) or calorie-restricted normal protein diet (NPD) (15%) for 8 weeks. Baseline dietary intake patterns were assessed by the Diet History Questionnaire III. Longitudinal fecal sampling was performed at baseline, week 1, week 2, week 4, week 6, and week 8, for a total of 365 samples. Intestinal microbiome composition was assessed by 16S rRNA gene sequencing.
RESULTS


At baseline, microbial composition was associated with fiber and protein intake. Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD. The HPD was also associated with significant differences in microbial composition after treatment compared to the NPD. Both diets induced taxonomic shifts compared to baseline, including enrichment of  Akkermansia spp.  and  Bifidobacterium spp.  and depletion of  Prevotella spp.  Conclusion: These findings provide evidence that weight loss diets alter the gut microbiome in obesity and suggest differential effects of HPDs compared to NPDs which may influence the clinical response to HPD.",2020,Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD.,['80 overweight and obese subjects'],['calorie-restricted high protein diet (HPD) (30% calorie intake) or calorie-restricted normal protein diet (NPD'],"['Shannon index', 'microbial diversity', 'microbial composition', 'taxonomic shifts', 'Baseline dietary intake patterns', 'Intestinal microbiome composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0860902', 'cui_str': 'Protein NOS normal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",80.0,0.0173795,Subjects on the HPD showed a significant increase in microbial diversity as measured by the Shannon index compared to those on the NPD.,"[{'ForeName': 'Tien S', 'Initials': 'TS', 'LastName': 'Dong', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Kayti', 'Initials': 'K', 'LastName': 'Luu', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Lagishetty', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Sedighian', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Shih-Lung', 'Initials': 'SL', 'LastName': 'Woo', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Dreskin', 'Affiliation': 'Division of Gastroenterology, Hepatology and Parenteral Nutrition, Veterans Administration Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Katzka', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Candace', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'Arias-Jayo', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Ahdoot', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'UCLA Microbiome Center, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Pisegna', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'The Vatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.'}]",Nutrients,['10.3390/nu12103221']
1466,33096965,Effects of Interval-Training Exercise on People Who Have Had Persistent Post-Concussive Symptoms for Less Than One Year: A Pilot Study.,"This study is to examine the effects of a 12-session moderate intensity-interval-training program with blood flow restriction (BFR) and body cooling (BC) on people who have had persistent post-concussive symptoms (PPCS) for <1 year. A single-blind randomized controlled trial of interval-training exercise with BFR and BC was conducted. Twenty-five adults with PPCS were assigned to the experimental group ( n  = 14) or the control group ( n  = 11). Both groups rode a recumbent elliptical machine for 21 min at moderate intensity (65% predicted maximum heart rate) twice a week for 6 weeks, but only the experimental group received BFR and BC while riding. The variances of overall PPCS scale scores and their sub-domain scores for individuals during the 6-week intervention and 6-week follow-up period were calculated. During the intervention, the fluctuation of overall symptom severity, severity in the cognitive domain and severity in the mood domain were significantly less in the experimental group ( p  = 0.03;  p  = 0.02;  p  = 0.02). During the follow-up period, the number of symptoms remained more stable in the experimental group ( p  = 0.02), and a trend toward less fluctuation of symptom severity ( p  = 0.05) was also observed. The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention ( p  = 0.007;  p  = 0.02). The severity of mood and sleep symptoms also remained more stable during the follow-up period in the experimental group ( p  = 0.04). More stable recovery was found in individuals who exercised using BFR and BC than in those who underwent exercise without BFR and BC. Moderate intensity-interval-training exercise with BFR and BC alleviated post-concussive symptoms in people who have had PPCS <1 year.",2020,The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention (p=0.007; p=0.02).,"['people with persistent post-concussive symptoms (PPCS) less than one year', 'people with persistent post-concussive symptoms less than one year', 'Twenty-five adults with PPCS', 'people with PPCS less than one year']","['interval-training exercise', '12-session moderate intensity-interval-training program with blood flow restriction (BFR) and body cooling (BC']","['number of symptoms', 'number of symptoms in the cognitive and sleep domains', 'severity of mood and sleep symptoms', 'variances of overall persistent post-concussive symptom scale scores and its sub-domain scores', 'fluctuation of symptom severity', 'fluctuation of overall symptom severity, severity in cognitive domain and severity in mood domain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",25.0,0.0336548,The reduced number of symptoms in the cognitive and sleep domains remained more stable in the experimental group following the intervention (p=0.007; p=0.02).,"[{'ForeName': 'Yi-Ning', 'Initials': 'YN', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Therapy and Kinesiology, University of Massachusetts Lowell, Lowell, Massachusetts, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Stark', 'Affiliation': 'Department of Physical Therapy and Kinesiology, University of Massachusetts Lowell, Lowell, Massachusetts, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gravel', 'Affiliation': 'Dr. Robert C. Cantu Concussion Center, Emerson Hospital, Concord, Massachusetts, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Dr. Robert C. Cantu Concussion Center, Emerson Hospital, Concord, Massachusetts, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Avery', 'Affiliation': 'Dr. Robert C. Cantu Concussion Center, Emerson Hospital, Concord, Massachusetts, USA.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Enis', 'Affiliation': 'Dr. Robert C. Cantu Concussion Center, Emerson Hospital, Concord, Massachusetts, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Cantu', 'Affiliation': 'Dr. Robert C. Cantu Concussion Center, Emerson Hospital, Concord, Massachusetts, USA.'}]",Journal of neurotrauma,['10.1089/neu.2019.6915']
1467,33097954,"An Expression of Concern from The Journal of Nutrition's Editorial Office about: Vitamin D Supplementation Affects the Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress in Patients with Major Depressive Disorder: A Randomized, Controlled Clinical Trial.",,2020,,['Patients with Major Depressive Disorder'],['Vitamin D Supplementation'],"['Beck Depression Inventory, Insulin Resistance, and Biomarkers of Oxidative Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.232398,,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sepehrmanesh', 'Affiliation': ''}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Kolahdooz', 'Affiliation': ''}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abedi', 'Affiliation': ''}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazroii', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Assarian', 'Affiliation': ''}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa341']
1468,33098434,Effects of long-term vitamin D and n-3 fatty acid supplementation on inflammatory and cardiac biomarkers in patients with type 2 diabetes: secondary analyses from a randomised controlled trial.,"AIMS/HYPOTHESIS


Interventions that reduce inflammation may delay progression of microvascular and macrovascular complications in diabetes. We examined the effects of vitamin D 3  and/or n-3 fatty acid supplementation vs placebo on 5 year changes in serum inflammatory and cardiac biomarkers in adults with type 2 diabetes.
METHODS


This study reports pre-specified secondary outcomes of the Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease, in which 1312 US adults with type 2 diabetes and without known cardiovascular disease, malignancy, or end-stage kidney disease were randomised using computer-generated random numbers in blocks of eight to vitamin D 3  (2000 IU/day) vs placebo and n-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]; 1 g/day) vs placebo in a 2 × 2 factorial design. Participants, examiners, and researchers assessing outcomes were blinded to intervention assignment. We measured serum IL-6, high-sensitivity C-reactive protein (hsCRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) at baseline and after 2 and 5 years.
RESULTS


A total of 333 participants were randomised to vitamin D 3  and placebo n-3 fatty acids, 289 to n-3 fatty acids and placebo vitamin D 3 , 370 to vitamin D 3  and n-3 fatty acids, and 320 to 2 placebos; 989 (75%) and 934 (71%) participants returned blood samples at 2 and 5 years, respectively. Participants had a mean age of 67.6 years (46% women). Overall, baseline geometric means of IL-6, hsCRP and NT-proBNP were 1.2 pg/ml, 1.9 mg/l and 262 ng/l, respectively. After 5 years, mean IL-6 and hsCRP remained within 6% of their baseline values while mean NT-proBNP increased by 55% overall. Compared with placebo, participants assigned to vitamin D 3  had a 1.24-fold greater increase in NT-proBNP over 5 years (95% CI 1.09, 1.41; p = 0.003), while IL-6 and hsCRP did not have a significant difference in change. Comparing n-3 fatty acids with placebo, there was no significant difference in change in IL-6, hsCRP or NT-proBNP. No heterogeneity was observed in subgroup analyses accounting for baseline eGFR, urine albumin to creatinine ratio, initial biomarker concentration, 25-hydroxyvitamin D level or EPA+DHA index.
CONCLUSIONS/INTERPRETATION


Among adults with type 2 diabetes, supplementation with vitamin D 3  or n-3 fatty acids did not reduce IL-6, hsCRP or NT-proBNP over 5 years.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01684722 FUNDING: The study was funded by grant R01DK088762 from the National Institute of Diabetes and Digestive and Kidney Diseases. Graphical abstract.",2020,"Comparing n-3 fatty acids with placebo, there was no significant difference in change in IL-6, hsCRP or NT-proBNP.","['patients with type 2 diabetes', '1312 US adults with type 2 diabetes and without known cardiovascular disease, malignancy, or end-stage kidney disease', 'adults with type 2 diabetes', 'diabetes', '333 participants', 'Participants had a mean age of 67.6\xa0years (46% women']","['vitamin D 3  or n-3 fatty acids', 'vitamin D 3  and/or n-3 fatty acid supplementation vs placebo', 'n-3 fatty acids with placebo', 'vitamin D 3  and placebo n-3 fatty acids, 289 to n-3 fatty acids and placebo vitamin D 3 , 370 to vitamin D 3  and n-3 fatty acids, and 320 to 2 placebos', 'Vitamin D and Omega-3 Trial', 'placebo', 'long-term vitamin D and n-3 fatty acid supplementation', 'placebo and n-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA']","['Overall, baseline geometric means of IL-6, hsCRP and NT-proBNP', 'mean IL-6 and hsCRP', 'change in IL-6, hsCRP or NT-proBNP', 'mean NT-proBNP', 'NT-proBNP', 'IL-6', 'serum inflammatory and cardiac biomarkers', 'baseline eGFR, urine albumin to creatinine ratio, initial biomarker concentration, 25-hydroxyvitamin D level or EPA+DHA index', 'serum IL-6, high-sensitivity C-reactive protein (hsCRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP', 'inflammatory and cardiac biomarkers', 'IL-6, hsCRP or NT-proBNP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",333.0,0.737164,"Comparing n-3 fatty acids with placebo, there was no significant difference in change in IL-6, hsCRP or NT-proBNP.","[{'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Limonte', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA. climonte@uw.edu.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ruzinski', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Thadhani', 'Affiliation': 'Office of the Chief Academic Officer, Partners HealthCare, Boston, MA, USA.'}, {'ForeName': 'Michal L', 'Initials': 'ML', 'LastName': 'Melamed', 'Affiliation': 'Division of Nephrology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle, WA, USA.'}]",Diabetologia,['10.1007/s00125-020-05300-7']
1469,33098995,Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study).,"BACKGROUND


The efficacy and toxicity of olaparib as combination therapy in early breast cancer (BC) patients with homologous recombinant deficiency (HRD) [score high and/or germline (g) or tumour (t) BRCA1/2 mutation] is not well described. GeparOLA (ClinicalTrials.gov, NCT02789332) investigated olaparib in combination with paclitaxel in HER2-negative early BC with HRD.
PATIENTS AND METHODS


Patients with untreated primary HER2-negative cT2-cT4a-d or cT1c with either cN+ or pNSLN+ or cT1c and triple-negative breast cancer (TNBC) or cT1c and Ki-67>20% BC with HRD were randomised either to paclitaxel (P) 80 mg/m 2  weekly plus olaparib (O) 100 mg twice daily for 12 weeks or P plus carboplatinum (Cb) area under the curve 2 weekly for 12 weeks, both followed by epirubicin/cyclophosphamide (EC). Stratification factors were hormone receptor (HR) status (HR+ versus HR-) and age (<40 versus ≥40 years). The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). A two-sided one-group χ 2 -test was planned to exclude a pCR rate of ≤55% in the PO-EC arm. Secondary end points were other pCR definitions, breast conservation rate, clinical/imaging response, tolerability and safety.
RESULTS


A total of 107 patients were randomised between September 2016 and July 2018; 106 (PO N = 69; PCb N = 37) started treatment. Median age was 47.0 years (range 25.0-71.0); 36.2% had cT1, 61.0% cT2, 2.9% cT3, and 31.8% cN-positive tumours; grade 3 tumours: 86.8%; Ki-67>20%: 89.6%; TNBC: 72.6%; confirmed gBRCA1/2 mutation: 56.2%. The pCR rate with PO was 55.1% [90% confidence interval (CI) 44.5% to 65.3%] versus PCb 48.6% (90% CI 34.3% to 63.2%). Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients.
CONCLUSION


GeparOLA could not exclude a pCR rate of ≤55% in the PO arm. PO was significantly better tolerated and the combination merits further evaluation.",2020,"Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients.
","['patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study', 'Patients with untreated primary HER2-negative cT2-cT4a-d or cT1c with either cN+ or pNSLN+ or cT1c and TNBC or cT1c and Ki-67>20% BC with HRD', 'early breast cancer (BC) patients with homologous recombinant deficiency (HRD score high and/or germline (g) or tumour (t) BRCA1/2 mutation', 'A total of 107 patients were randomised between 09/2016 and 07/2018; 106 (PO N=69; PCb N=37) started treatment']","['paclitaxel/carboplatinum', 'pCR', 'paclitaxel', 'epirubicin/cyclophosphamide (EC', 'Neoadjuvant paclitaxel/olaparib', 'olaparib', 'paclitaxel (P) 80mg/m 2  weekly plus olaparib (O) 100mg twice daily for 12 weeks or P plus carboplatinum']","['rate with PO', 'pCR definitions, breast conservation rate, clinical/imaging response, tolerability and safety', 'pCR rate', 'pCR rates', 'hormone receptor (HR) status (HR+ vs HR-) and age ', 'pathological complete response ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0032447', 'cui_str': 'Polychlorinated biphenyl'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4520026', 'cui_str': 'olaparib 100 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449443', 'cui_str': 'Receptor status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",107.0,0.120765,"Analysis for the stratified subgroups showed higher pCR rates with PO in the cohorts of patients <40 years and HR+ patients.
","[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-Nuremberg, National Center for Tumor Diseases, Erlangen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Link', 'Affiliation': 'Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus Dresden, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hauke', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Seither', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum Offenbach, Offenbach, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Klare', 'Affiliation': 'MediOnko-Institut GbR Berlin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schmatloch', 'Affiliation': 'Elisabeth Krankenhaus Kassel, Kassel, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum Munich, Munich, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stefek', 'Affiliation': 'Johanniter-Krankenhaus Genthin-Stendal, Stendal, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uleer', 'Affiliation': 'Gemeinschaftspraxis Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Doering', 'Affiliation': 'Hämato-Onkologie im Medicum Bremen, Bremen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases (NCT), Heidelberg University Hospital and German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Engels', 'Affiliation': 'Center for Pathology, Cytology and Molecular Pathology Neuss, Neuss, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Philipps-Universität Marburg und University Hospital Marburg (UKGM), Marburg, Germany.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Schmutzler', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hahnen', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, University of Cologne, Cologne, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios-Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Burchardi', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Brustzentrum Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany. Electronic address: sibylle.loibl@gbg.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.471']
1470,33098997,Overall survival with 3 or 6 months of adjuvant chemotherapy in Italian TOSCA phase 3 randomised trial.,"BACKGROUND


Oxaliplatin-based adjuvant chemotherapy is the standard treatment of high-risk colon cancer (CC). A shorter duration (3 months) can achieve a similar outcome [in terms of relapse-free survival (RFS)] to a longer duration. This study reports the overall survival (OS) analysis of the three or six colon adjuvant (TOSCA) phase III study. It assessed different adjuvant chemotherapy durations in patients with resected high-risk stage II and stage III CC.
MATERIAL AND METHODS


TOSCA was an open-label, phase III, multicentre, non-inferiority trial conducted in 130 Italian centres. Patients were randomly assigned, in a 1 : 1 ratio, to receive 3 months of standard doses of FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX. Patients with histologically confirmed high-risk stage II and III CC were included, with RFS being the primary end point. OS was a secondary end point.
RESULTS


From June 2007 to March 2013, 3759 patients were accrued. At a median follow-up of 7 years, the hazard ratio (HR) for RFS of the 3-month versus 6-month arms was 1.13; 95% confidence interval (CI) 0.99-1.29, P for non-inferiority = 0.380, P for superiority = 0.068, crossing the non-inferiority limit of 1.20. This result did not allow us to reject the null hypothesis of the inferiority of the 3-month arm. The HR for OS of the 3-month versus 6-month arms was 1.09 (95% CI 0.93-1.26, P for superiority = 0.288). At the last follow-up analysis, the absolute OS difference between arms was <1%.
CONCLUSIONS


The present analysis of the TOSCA trial does not indicate any significant difference in OS between the treatment groups. The extra benefit provided by the longer treatment should be balanced against the extra toxicity of more prolonged therapy. The trial is registered with ClinicalTrials.gov, registration number: NCT0064660.",2020,A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration.,"['Patients with histologically confirmed high-risk stage II and III CC', '130 Italian centres', 'patients with resected high-risk stage II and stage III CC', 'From June 2007 to March 2013, 3759 patients were accrued', 'high-risk colon cancer (CC']","['adjuvant chemotherapy', 'FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX', 'Oxaliplatin-based adjuvant chemotherapy']","['overall survival (OS', 'Overall survival', 'absolute OS difference', 'hazard ratio (HR) for RFS', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",3759.0,0.310107,A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Petrelli', 'Affiliation': 'Medical Oncology Unit, Treviglio, Caravaggio Hospital, Treviglio, Bergamo, Italy. Electronic address: faupe@libero.it.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto - IRCCS, Padua, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dotti', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Medical Oncology Unit, Ospedale San Raffaele - IRCCS, Milan, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pusceddu', 'Affiliation': 'Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumours, IRCCS, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yasmina', 'Affiliation': 'Medical Oncology Unit, Rovigo Hospital, Rovigo, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""Medical Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome and IDI-IRCCS, Rome, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantore', 'Affiliation': 'Medical Oncology Unit, ASST Mantova, Mantua, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Haematology Unit, Humanitas Cancer Centre, Humanitas Clinical and Research Centre-IRCSS, Rozzano (MI), Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Molinette, Turin, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto - IRCCS, Padua, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology Unit, Hospital Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology Unit, IRCCS San Martino-IST, Genoa, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.477']
1471,33099015,"Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design.","Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during infancy increases the risk of obesity later in life and could be prevented through multi-modal interventions addressing multiple risk factors through population-level programs.
OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
METHODS


The lifestyle intervention focuses on age-appropriate infant physical activation, healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling. It is being tested among caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12 months of age. The main outcome is infant rate of weight gain at 12 months; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors. We are also recording fees, time and personnel involved in the intervention development, maintenance and dissemination.
CONCLUSIONS


If successful, the intervention could be incorporated as a 'best practice' through WIC policy as a means to strengthen obesity prevention efforts to improve minority health and eliminate health disparities among Hispanics and possibly other at-risk groups beyond the childhood period. Clinicaltrials.gov registration: NCT03517891.",2020,"OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
",['caregivers of infant participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 14 WIC clinics in San Juan starting in pregnancy until the infant is 12\u202fmonths of age'],"['healthy sleep and sedentary patterns, and response feeding, by improving parenting skills delivered through a combination of technology (web-platform and text messages) and phone counseling']","['infant rate of weight gain at 12\u202fmonths; secondary outcomes include objectively measured hours of infant movement, sedentary behaviors and sleep, diet quality score and response feeding behaviors', 'Rapid weight gain', 'healthy weight gain and specific behaviors (physical activity, sleep, diet']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C4277516', 'cui_str': 'Special Supplemental Nutrition Program for Women, Infants, and Children (U.S.)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",14.0,0.0627379,"OBJECTIVES


1) determine the extent to which the intervention, compared with the usual care control condition, improves healthy weight gain and specific behaviors (physical activity, sleep, diet) in the first year of life and 2) evaluate the cost of the intervention as a modification of the current WIC standard of care.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Dental and Craniofacial Genomics Core, Endocrinology Section School of Medicine, University of Puerto Rico, San Juan 00936-5067, Puerto Rico. Electronic address: maribel.campos@upr.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pomeroy', 'Affiliation': 'Clinical Research Center, Marshfield Clinic Research Institute, Marshfield Clinic Health System, Marshfield, WI, USA. Electronic address: pomeroyj@marshfieldclinic.org.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Mays', 'Affiliation': 'Biomedical Informatics Core, Puerto Rico Clinical and Translational Research Consortium, San Juan, Puerto Rico. Electronic address: mary.mays@upr.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Sports and Leisure Management program and Adapted Physical Education program, School of Education, Metropolitan University, San Juan Puerto Rico. Electronic address: lopeza1@suagm.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, Miami USA. Electronic address: cristina.palacios@fiu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106185']
1472,33103504,Lung sonography can improve the specificity of determination of left-sided double-lumen tracheal tube position in both novices and experts: a randomised prospective study.,"OBJECTIVE


Lung sonography can be helpful to determine the position of a left-sided double-lumen tube (DLT). However, clinical experience is required for correct assessment. We investigated whether lung sonography can improve the diagnostic efficacy of determining the DLT position in novices and experts.
METHODS


In this randomised prospective clinical study, 88 patients were allocated to two groups using auscultation or lung sonography for initial assessment of the DLT position. In each group, two repeated assessments were performed; the first was performed by a novice, and the second was performed by an expert. The final DLT position was confirmed by fibre-optic bronchoscopy. The primary outcome was the diagnostic efficacy (including overall accuracy, sensitivity, and specificity) in confirming the DLT position.
RESULTS


In both the novices and experts, the specificity of determining the DLT position was significantly higher with lung sonography than auscultation (60.0% vs. 21.7% and 66.7% vs. 37.5%, respectively). Additionally, the predictability of an incorrect position was similar between the novices and experts using lung sonography (area under the curve of 0.665 and 0.690, respectively).
CONCLUSIONS


Lung sonography can improve the diagnostic efficacy of detecting an incorrect DLT position in both novices and experts.",2020,"In both the novices and experts, the specificity of determining the DLT position was significantly higher with lung sonography than auscultation (60.0% vs. 21.7% and 66.7% vs. 37.5%, respectively).",['88 patients'],"['Lung sonography', 'auscultation or lung sonography for initial assessment of the DLT position']","['diagnostic efficacy', 'specificity of determining the DLT position', 'diagnostic efficacy (including overall accuracy, sensitivity, and specificity', 'predictability of an incorrect position']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",88.0,0.0313097,"In both the novices and experts, the specificity of determining the DLT position was significantly higher with lung sonography than auscultation (60.0% vs. 21.7% and 66.7% vs. 37.5%, respectively).","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'YoonJu', 'Initials': 'Y', 'LastName': 'Go', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Department of Medicine, Graduate School, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Yong Seok', 'Initials': 'YS', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Bong-Jae', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Hyungseok', 'Initials': 'H', 'LastName': 'Seo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.'}]",The Journal of international medical research,['10.1177/0300060520964369']
1473,33103819,A ketogenic drink improves cognition in mild cognitive impairment: Results of a 6-month RCT.,"INTRODUCTION


Counteracting impaired brain glucose metabolism with ketones may improve cognition in mild cognitive impairment (MCI).
METHODS


Cognition, plasma ketone response, and metabolic profile were assessed before and 6 months after supplementation with a ketogenic drink containing medium chain triglyceride (ketogenic medium chain triglyceride [kMCT]; 15 g twice/day; n = 39) or placebo (n = 44).
RESULTS


Free and cued recall (Trial 1; P = .047), verbal fluency (categories; P = .024), Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates). Some cognitive outcomes also correlated positively with plasma ketones. Plasma metabolic profile and ketone response were unchanged.
CONCLUSIONS


This kMCT drink improved cognitive outcomes in MCI, at least in part by increasing blood ketone level. These data support further assessment of MCI progression to Alzheimer's disease.",2020,"Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates).","['mild cognitive impairment', 'mild cognitive impairment (MCI']","['ketogenic drink containing medium chain triglyceride (ketogenic medium chain triglyceride [kMCT', 'ketogenic drink', 'placebo', 'kMCT']","['Plasma metabolic profile and ketone response', 'cognitive outcomes', 'verbal fluency', 'Cognition, plasma ketone response, and metabolic profile', 'plasma ketones', 'blood ketone level', 'Free and cued recall']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1271768', 'cui_str': 'Blood ketone level'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0919339,"Boston Naming Test (total correct answers; P = .033), and the Trail-Making Test (total errors; P = .017) improved significantly in the kMCT group compared to placebo (analysis of covariance; pre-intervention score, sex, age, education, and apolipoprotein E4 as covariates).","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Fortier', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Christian-Alexandre', 'Initials': 'CA', 'LastName': 'Castellano', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'St-Pierre', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Étienne', 'Initials': 'É', 'LastName': 'Myette-Côté', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Langlois', 'Affiliation': ""CIUSSS de l'Éstrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Morin', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bocti', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Fulop', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Godin', 'Affiliation': 'Institute of Food Safety and Analytical Sciences, Nestlé Research, Lausanne, Switzerland.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Delannoy', 'Affiliation': 'Nestlé Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Cuenoud', 'Affiliation': 'Nestlé Health Sciences, Lausanne, Switzerland.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Cunnane', 'Affiliation': ""Research Center on Aging, CIUSSS de l'Estrie-CHUS, Sherbrooke, Quebec, Canada.""}]",Alzheimer's & dementia : the journal of the Alzheimer's Association,['10.1002/alz.12206']
1474,33107002,The Gears of Knowledge Translation: Process Evaluation of the Dissemination and Implementation of a Patient Engagement Toolkit.,"BACKGROUND


Patient engagement is a key tenet of patient-centered care and is associated with many positive health outcomes. To improve resources for patient engagement, we created a web-based, interactive patient engagement toolkit to improve patient engagement in primary care across the Veterans Health Administration (VHA).
OBJECTIVE


To use the knowledge translation (KT) framework to evaluate the dissemination and implementation of a patient engagement toolkit at facilities across one region in the VHA.
DESIGN


Using a mixed-methods approach, this process evaluation involved phone monitoring via semi-structured interviews and group meetings, during which we explored barriers and facilitators to KT. Outcomes were assessed using a structured rubric and existing patient satisfaction measures.
PARTICIPANTS


We enlisted implementers at 40 VHA facilities primarily serving Pennsylvania, New Jersey, and Delaware to implement patient engagement practices at their sites. Sites were randomly assigned into a high or low coaching group to assess whether external support influenced implementation.
KEY RESULTS


Sites with high rubric scores employed and possessed several elements across the KT trajectory from identification of the problem to sustainment of knowledge use. Key factors for successful implementation and dissemination included implementer engagement, organizational support, and strong collaborators. The most frequently cited barriers included short staffing, time availability, lack of buy-in, and issues with leadership. Successful implementers experienced just as many barriers, but leveraged facilitators to overcome obstacles. While sites that received more coaching did not have different outcomes, they were more likely to revisit the toolkit and indicated that they felt more accountable to local personnel.
CONCLUSIONS


Because leveraging available resources is a key component of successful implementation, future toolkits should highlight the type of facilitators necessary for successful implementation of toolkit content in healthcare settings. The ability to tailor interventions to local context is critical for overcoming barriers faced in most healthcare settings.",2020,"While sites that received more coaching did not have different outcomes, they were more likely to revisit the toolkit and indicated that they felt more accountable to local personnel.
","['We enlisted implementers at 40 VHA facilities primarily serving Pennsylvania, New Jersey, and Delaware to implement patient engagement practices at their sites']",['low coaching group to assess whether external support influenced implementation'],[],"[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0027971', 'cui_str': 'New Jersey'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0746443,"While sites that received more coaching did not have different outcomes, they were more likely to revisit the toolkit and indicated that they felt more accountable to local personnel.
","[{'ForeName': 'Shimrit', 'Initials': 'S', 'LastName': 'Keddem', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA. shimrit.keddem@va.gov.'}, {'ForeName': 'Aneeza Z', 'Initials': 'AZ', 'LastName': 'Agha', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Shasha', 'Affiliation': 'Jhpiego Corporation, an affiliate of Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Leslie R M', 'Initials': 'LRM', 'LastName': 'Hausmann', 'Affiliation': 'Veterans Affairs Pittsburgh Healthcare System, VA Center for Health Equity Research and Promotion (CHERP), Pittsburgh, PA, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'VISN 4 Center for the Evaluation of Patient Aligned Care Teams (CEPACT), Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06099-0']
1475,33104375,Recitation and listening to nursery rhymes in the familiarization with a literacy language in kindergarteners: Not kids' stuff.,"A large linguistic distance exists between spoken Arabic and the Modern Standard Arabic (MSA) the literary language (a diglosia). Novice readers, therefore, struggle with the complex orthography of Arabic as well as the mastering of MSA. Here, we tested whether structured activities in MSA would advance kindergarteners' MSA aptitude by the end of the school year. We examined two issues: (a) whether reciting nursery rhymes in MSA would be more effective in promoting language and preliteracy skills in kindergarteners compared to listening to the same texts, and (b) whether there are additional advantages for using texts directly referring to the alphabet. Thus, 136 kindergarteners ( M age  = 5:6; 61 girls), all native speakers of Arabic and with middle-low socioeconomic background, were assigned to a 10-session (2 months) program in 1 of 4 intervention conditions wherein nursery rhymes related/not related to the alphabet, were either repeatedly recited or listened to. The achievements of children in the intervention conditions were compared to those of peers that were given nonlinguistic activity of similar length (control). The four intervention groups improved their performance at the postintervention assessment in all tests of MSA aptitude and outperformed the control group in receptive and expressive vocabulary and listening comprehension. Also, the reciting groups were better than the control and listening groups in tests assessing vocabulary and morpho-syntactic sensitivity. Our results highlight the contribution of structured interventions based on rhyme repetition to MSA proficiency of kindergarteners. Moreover, the results suggest that reciting may be superior to listening in advancing language proficiency in preschoolers. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Also, the reciting groups were better than the control and listening groups in tests assessing vocabulary and morpho-syntactic sensitivity.","['136 kindergarteners ( M age  = 5:6; 61 girls), all native speakers of Arabic and with middle-low socioeconomic background']","['10-session (2 months) program in 1 of 4 intervention conditions wherein nursery rhymes related/not related to the alphabet, were either repeatedly recited or listened to']","['tests assessing vocabulary and morpho-syntactic sensitivity', 'receptive and expressive vocabulary and listening comprehension']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0323245', 'cui_str': 'Morpho'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",,0.0155686,"Also, the reciting groups were better than the control and listening groups in tests assessing vocabulary and morpho-syntactic sensitivity.","[{'ForeName': 'Hazar', 'Initials': 'H', 'LastName': 'Eghbaria-Ghanamah', 'Affiliation': 'Department of Learning Disabilities, University of Haifa.'}, {'ForeName': 'Rafat', 'Initials': 'R', 'LastName': 'Ghanamah', 'Affiliation': 'Department of Learning Disabilities, University of Haifa.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Shalhoub-Awwad', 'Affiliation': 'Department of Learning Disabilities, University of Haifa.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Adi-Japha', 'Affiliation': 'School of Education, Bar-Ilan University.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol Department of Neurobiology, Brain-Behavior Research Center, University of Haifa.'}]",Developmental psychology,['10.1037/dev0001124']
1476,33105245,Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial.,"BACKGROUND


Corticosteroids can reduce pain but the optimal dose and safety profiles are still uncertain.
OBJECTIVE


This study aimed to evaluate two different doses of dexamethasone for pain management and their side effects after total knee arthroplasty.
DESIGN


A prospective randomised, controlled trial.
SETTING


A tertiary teaching hospital in Hong Kong.
PATIENTS


One hundred and forty-six patients were randomly allocated to one of three study groups.
INTERVENTIONS


Before operation, patients in group D8, D16 and P received dexamethasone 8 mg, dexamethasone 16 mg and placebo (0.9% saline), respectively.
MAIN OUTCOME MEASURES


The primary outcome was postoperative pain score. Secondary outcomes were opioid consumption, physical parameters of the knees and side effects of dexamethasone.
RESULTS


Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3 [-1.3 (95% CI, -2.2 to -0.31), P = 0.005]. There was also a significant dose-dependent trend between pain scores and dexamethasone dose (P = 0.002). Compared with placebo, patients in group D16 consumed significantly less opioid [-6.4 mg (95% CI, -11.6 to -1.2), P = 0.025] and had stronger quadriceps power on the first three postoperative days (all P < 0.05). They also had significantly longer walking distance on postoperative day 1 [7.8 m ([95% CI, 0.85 to 14.7), P = 0.023] with less assistance during walking on the first two postoperative days (all P < 0.029) and significantly better quality-of-recovery scores on postoperative day 1 (P = 0.018). There were significant dose-dependent trends between all the above parameters and dexamethasone dose (all P < 0.05). No significant differences were found in the incidence of chronic pain or knee function 3, 6 and 12 months postoperatively.
CONCLUSION


Dexamethasone 16 mg given before total knee arthroplasty led to a reduction in postoperative pain, less opioid consumption, stronger quadriceps muscle power, better mobilisation and better overall quality-of-recovery after operation. No long-term improvement in reduction in pain and function of the knee was found.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02767882.",2020,"Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3","['One hundred and forty-six patients', 'pain relief after total knee arthroplasty', 'A tertiary teaching hospital in Hong Kong', 'total knee arthroplasty']","['dexamethasone', 'Dexamethasone', 'placebo', 'dexamethasone 8\u200amg, dexamethasone 16\u200amg and placebo', 'Preoperative dexamethasone']","['longer walking distance', 'opioid consumption, physical parameters of the knees and side effects of dexamethasone', 'quality-of-recovery scores', 'pain', 'chronic pain or knee function', 'postoperative pain, less opioid consumption, stronger quadriceps muscle power, better mobilisation and better overall quality-of-recovery', 'pain and function of the knee', 'pain during maximal active flexion', 'pain scores', 'postoperative pain score']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",146.0,0.535529,"Compared with placebo, group D16 patients had significantly less pain during maximal active flexion on postoperative day 3","[{'ForeName': 'Timmy Chi Wing', 'Initials': 'TCW', 'LastName': 'Chan', 'Affiliation': 'From the Department of Anaesthesiology, Queen Mary Hospital (TCWC, AYFC), Department of Anaesthesiology, University of Hong Kong (CWC, SSCW, MGI), Department of Orthopaedics and Traumatology, Queen Mary Hospital (PKC, HF), Department of Orthopaedics and Traumatology, University of Hong Kong, Hong Kong, China (CHY, KYC).'}, {'ForeName': 'Chi Wai', 'Initials': 'CW', 'LastName': 'Cheung', 'Affiliation': ''}, {'ForeName': 'Stanley Sau Ching', 'Initials': 'SSC', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Arthur Yu Fai', 'Initials': 'AYF', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Irwin', 'Affiliation': ''}, {'ForeName': 'Ping Keung', 'Initials': 'PK', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Chun Hoi', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Kwong Yuen', 'Initials': 'KY', 'LastName': 'Chiu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001372']
1477,33105246,"Differential lung ventilation assessed by electrical impedance tomography in ultrasound-guided anterior suprascapular nerve block vs. interscalene brachial plexus block: A patient and assessor-blind, randomised controlled trial.","BACKGROUND


Ultrasound-guided interscalene brachial plexus block (ISB) is used to control pain after shoulder surgery. Though effective, drawbacks include phrenic nerve block and motor block of the hand. The ultrasound-guided anterior approach to perform suprascapular nerve block (SSNB) may provide a good alternative.
OBJECTIVE


To compare lung ventilation and diaphragmatic activity on the operated side in ISB and SSNB.
DESIGN


Randomised, controlled patient-blinded and assessor-blinded trial.
SETTING


Outpatient surgical clinic with recruitment from June 2017 to January 2018.
PATIENTS


Fifty-five outpatients scheduled for arthroscopic shoulder surgery were allocated randomly to receive SSNB or ISB. Technical problems with monitoring devices unrelated to the intervention led to exclusion of seven patients. The remaining 48 (n=24 in each group) were followed up for 24 h without drop-outs.
INTERVENTIONS


Patients received 10 ml of ropivacaine 1.0% wt/vol for both procedures.
OUTCOME MEASURES


Percentage lung ventilation on the operated side was the primary endpoint as assessed with electrical impedance tomography (EIT). Secondary endpoints were hemidiaphragmatic motion on the operated side, pain, opioid use, hand strength and numbness, and patient satisfaction.
RESULTS


Before regional anaesthesia, the lung on the operated side contributed a median [IQR] of 50 [42 to 56]% of the total lung ventilation. Postoperatively, it was 40 [3 to 50]% (SSNB) vs. 3 [1 to 13]% (ISB) for an adjusted difference of 23 (95% CI, 13 to 34)%, (P < 0.001). Hemidiaphragmatic motion was 1.90 (95% CI, 1.37 to 2.44 cm), (P < 0.001) lower in the ISB group compared with the SSNB group. Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001. Pain was low in the first 6 h after surgery in both groups with slightly, but not significantly, lower values for ISB. No meaningful or significant differences were found for opioid use or patient satisfaction.
CONCLUSION


An ultrasound-guided anterior approach to SSNB preserves ipsilateral lung ventilation and phrenic function better than a standard ISB.
TRIAL REGISTRATION


drks.de identifier: DRKS00011787.",2020,"Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001.","['Fifty-five outpatients scheduled for arthroscopic shoulder surgery', 'Outpatient surgical clinic with recruitment from June 2017 to January 2018']","['SSNB or ISB', 'Ultrasound-guided interscalene brachial plexus block (ISB', 'ultrasound-guided anterior approach to perform suprascapular nerve block (SSNB', 'Differential lung ventilation assessed by electrical impedance tomography in ultrasound-guided anterior suprascapular nerve block vs. interscalene brachial plexus block', 'ropivacaine 1.0%\u200awt/vol for both procedures']","['Hand strength', 'hemidiaphragmatic motion on the operated side, pain, opioid use, hand strength and numbness, and patient satisfaction', 'electrical impedance tomography (EIT', 'lung ventilation and diaphragmatic activity', 'Pain', 'ipsilateral lung ventilation and phrenic function', 'opioid use or patient satisfaction', 'Hemidiaphragmatic motion', 'SSNB and numbness']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0559305', 'cui_str': 'Differential lung ventilation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]",55.0,0.14646,"Hand strength was 11.2 (95% CI 3.6 to 18.9), (P = 0.0024) kg greater for SSNB and numbness was observed in 0% (SSNB) vs. 46% (ISB) of patients, P < 0.001.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Petroff', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiegel', 'Affiliation': ''}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Pech', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Salz', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mrongowius', 'Affiliation': ''}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Reske', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001367']
1478,33112004,"Footbath as a safe, simple, and non-pharmacological method to improve sleep quality of menopausal women.","Due to the adverse effects of medication we decided to provide a safe, economic, and easy intervention to decrease sleep problems in menopausal women. This trial aimed to determine the effect of footbath on sleep disturbance in postmenopausal women. One hundred menopausal women were randomly stratified using a permuted block randomization procedure by Random Allocation Software, and assigned to one of two study groups: control (without intervention, n = 50) and intervention (footbath, n = 50). The footbath group was asked to lie their feet into the warm water for 20 min in a container with a depth of 10 cm one hour before the usual sleeping time for 6 weeks. To assess sleep quality, we used the Pittsburgh sleep quality index (PSQI). To evaluate severity of menopause symptoms, the Greene scale was applied. Before the intervention, 96% of the subjects in the footbath group and 94% in the control group were poor sleepers. The results of analysis of covariance showed significant improvement in sleep quality and decrease in severity of menopause signs in the footbath group compared to the control group. At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001, r = .464). The present study findings showed that footbath intervention enhanced sleep quality in menopausal women. Thus, footbath as a safe, simple, and non-pharmacological application can improve quality of life in postmenopausal women and inhibit problems due to inadequate sleep quality.",2020,"At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001,","['One hundred menopausal women', 'menopausal women', 'postmenopausal women']","['control (without intervention, n\u2009=\u200950) and intervention (footbath, n\u2009=\u200950', 'footbath', 'footbath intervention', 'Footbath']","['severity of menopause signs', 'sleep problems', 'severity of menopause signs and the global score of PSQI', 'sleep disturbance', 'quality of life', 'Pittsburgh sleep quality index (PSQI', 'sleep quality']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",100.0,0.0295432,"At the baseline, there was a statistically significant correlation between the severity of menopause signs and the global score of PSQI in all study individuals (p ≤ .001,","[{'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Aghamohammadi', 'Affiliation': 'Department of Nutrition, Khalkhal University of Medical sciences, Khalkhal, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Salmani', 'Affiliation': 'Department of Midwifery, Khalkhal University of Medical sciences, Khalkhal, Iran.'}, {'ForeName': 'Reyhaneh', 'Initials': 'R', 'LastName': 'Ivanbagha', 'Affiliation': 'Department of Midwifery, Khalkhal University of Medical sciences, Khalkhal, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Effati Daryani', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Nasiri', 'Affiliation': 'Department of Medical-Surgical Nursing, Khalkhal University of Medical sciences, Khalkhal, Iran.'}]",Research in nursing & health,['10.1002/nur.22082']
1479,33129754,Peer Support Added to Diabetes Education Improves Metabolic Control and Quality of Life in Mayan Adults Living With Type 2 Diabetes: A Randomized Controlled Trial.,"BACKGROUND


Yucatán, located in the southern region of Mexico, is the state with the country's highest prevalence of uncontrolled diabetes. Because of its particular cultural and socioeconomic characteristics, the residents of Yucatán face unique health-care challenges. The objective of our study was to evaluate the effect of peer support added to a diabetes education program on glycemic control and diabetes-related quality of life when compared with a conventional diabetes education program in patients with type 2 diabetes in a Mayan community in Mexico.
METHODS


In March 2015, a total of 58 participants with a previous diagnosis of type 2 diabetes who were recruited from community health centres in Komchén were randomly assigned in equal numbers to 1 of 2 groups: 1) a peer support and diabetes self-management education group (PSEG) or 2) a conventional diabetes self-management education-only group. The primary outcomes of interest were glycated hemoglobin (A1C) values and diabetes-related quality of life. The majority of subjects were bilingual (Mayan and Spanish speakers), female and middle aged, and had a low level of formal education and high baseline A1C (mean, 8.7%).
RESULTS


Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group. PSEG participants exhibited statistically significant improvement in diabetes-related quality of life at 8 months.
CONCLUSIONS


Our study demonstrates the benefits of peer-support education above and beyond the impact of diabetes self-management education on diabetes-related quality of life in an underserved Mayan community in Mexico.",2020,"Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group.","['patients with type 2 diabetes in a Mayan community in Mexico', '2 Diabetes', 'underserved Mayan community in Mexico', 'subjects were bilingual (Mayan and Spanish speakers), female and middle aged, and had a low level of formal education and high baseline A1C (mean, 8.7', '58 participants with a previous diagnosis of type 2 diabetes who were recruited from community health centres in Komchén', 'Mayan Adults Living With Type']","['peer support added to a diabetes education program', 'conventional diabetes education program', 'peer support and diabetes self-management education group (PSEG) or 2) a conventional diabetes self-management education-only group', 'Peer Support Added to Diabetes Education']","['diabetes-related quality of life', 'glycated hemoglobin (A1C) values and diabetes-related quality of life', 'Metabolic Control and Quality of Life', 'glycemic control and diabetes-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",58.0,0.0458887,"Whereas both groups showed significant improvements from baseline to study end in absolute levels of A1C, the PSEG group had a more pronounced clinical improvement, but no statistical improvement, in A1C compared with the conventional diabetes self-management education-only group.","[{'ForeName': 'Karen G', 'Initials': 'KG', 'LastName': 'Castillo-Hernandez', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico; Faculty of Medicine, Autonomous University of Yucatán, Mérida, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Laviada-Molina', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico. Electronic address: hlaviada@marista.edu.mx.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Hernandez-Escalante', 'Affiliation': 'Faculty of Medicine, Autonomous University of Yucatán, Mérida, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Molina-Segui', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Mena-Macossay', 'Affiliation': 'Marist University of Mérida, Mérida, Mexico.'}, {'ForeName': 'Augusto E', 'Initials': 'AE', 'LastName': 'Caballero', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.08.107']
1480,33129819,Comparisons of Nonhyperemic Pressure Ratios: Predicting Functional Results of Coronary Revascularization Using Longitudinal Vessel Interrogation.,"OBJECTIVES


The aim of this study was to investigate the accuracy of pre-percutaneous coronary intervention (PCI) predicted nonhyperemic pressure ratios (NHPRs) with actual post-PCI NHPRs and to assess the efficacy of PCI strategy using pre-PCI NHPR pullback.
BACKGROUND


Predicting the functional results of PCI is feasible using pre-PCI longitudinal vessel interrogation with the instantaneous wave-free ratio (iFR), a pressure-based, adenosine-free NHPR. However, the reliability of novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio [dPR]) for this purpose remains uncertain.
METHODS


In this prospective, multicenter, randomized controlled trial, vessels were randomly assigned to receive pre-PCI iFR, RFR, or dPR pullback (50 vessels each). The pre-PCI predicted NHPRs were compared with actual NHPRs after contemporary PCI using intravascular imaging. The number and the total length of treated lesions were compared between NHPR pullback-guided and angiography-guided strategies.
RESULTS


The predicted NHPRs were strongly correlated with actual NHPRs: iFR, r = 0.83 (95% confidence interval: 0.72 to 0.90; p < 0.001); RFR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001), and dPR, r = 0.84 (95% confidence interval: 0.73 to 0.91; p < 0.001). The number and the total length of treated lesions were lower with the NHPR pullback strategy than with the angiography-guided strategy, leading to physiological improvement.
CONCLUSIONS


Predicting functional PCI results on the basis of pre-procedural RFR and dPR pullbacks yields similar results to iFR. Compared with an angiography-guided strategy, a pullback-guided PCI strategy with any of the 3 NHPRs reduced the number and the total length of treated lesions. (Study to Examine Correlation Between Predictive Value and Post PCI Value of iFR, RFR and dPR; UMIN000033534).",2020,"The number and the total length of treated lesions were lower with the NHPR pull back strategy than with the angiography-guided strategy, leading to physiological improvement.
",[],"['pre-PCI iFR, RFR, or dPR pull back', 'Coronary Revascularization Using Longitudinal Vessel Interrogation', 'pre-percutaneous coronary intervention (PCI']","['reliability of novel NHPRs (resting full-cycle ratio [RFR] and diastolic pressure ratio [dPR', 'number and the total length of treated lesions', 'nonhyperemic pressure ratios (NHPRs', 'Predictive Value and Post PCI Value of iFR, RFR and dPR']",[],"[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0406778', 'cui_str': 'Dermatopathia pigmentosa reticularis'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1442095', 'cui_str': 'Pressure ratio'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0406778', 'cui_str': 'Dermatopathia pigmentosa reticularis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.097615,"The number and the total length of treated lesions were lower with the NHPR pull back strategy than with the angiography-guided strategy, leading to physiological improvement.
","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Omori', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan. Electronic address: omori@heart-center.or.jp.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kawase', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Mizukami', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan; Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Tanigaki', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Hirata', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Ota', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Sobue', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Miyake', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Itta', 'Initials': 'I', 'LastName': 'Kawamura', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Munenori', 'Initials': 'M', 'LastName': 'Okubo', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kamiya', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Yoriyasu', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiovascular Medicine, Nagoya Heart Center, Nagoya, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Nagoya Heart Center, Nagoya, Japan.'}, {'ForeName': 'Mitsuyasu', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Toyohashi, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Takahiko', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Toyohashi, Japan.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.060']
1481,33131393,Do the Number of Visits and the Cost of Musculoskeletal Care Improve Outcomes? More May Not Be Better.,"OBJECTIVES


To determine the relationship between health care use and the magnitude of change in patient-reported outcomes in individuals who received treatment for subacromial pain syndrome. The secondary objective was to determine the value of care, as measured by change in pain and disability per dollar spent.
DESIGN


Secondary analysis of a randomized clinical trial that investigated the effects of nonsurgical care for subacromial pain syndrome.
METHODS


Two groups of treatment responders were created, based on 1-year change in Shoulder Pain and Disability Index (SPADI) score (high, 46.83 points; low, 8.21 points). Regression analysis was performed to determine the association between health care use and 1-year change in SPADI score. Baseline SPADI score was used as a covariate in the regression analysis. Value was measured by comparing health care visits and costs expended per SPADI 1-point change between responder groups.
RESULTS


Ninety-eight patients were included; 38 were classified as high responders (mean 1-year SPADI change score, 46.83 points) and 60 were classified as low responders (1-year SPADI change score, 8.21 points). Neither unadjusted medical visits (5.89; 95% confidence interval [CI]: 4.35, 7.44 versus 6.30; 95% CI: 5.14, 7.46) nor medical costs ($1404.86; 95% CI: $1109.34, $1779.09 versus $1679.26; 95% CI: $1391.54, $2026.48) were significantly different between high and low responders, respectively.
CONCLUSION


Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year.  J Orthop Sports Phys Ther 2020;50(11):642-648. doi:10.2519/jospt.2020.9440 .",2020,Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year.  ,['individuals who received treatment for subacromial pain syndrome'],['nonsurgical care'],"['shoulder pain and disability', 'health care use and 1-year change in SPADI score', 'medical costs', 'unadjusted medical visits', 'health care visits and costs expended per SPADI 1-point change', 'Shoulder Pain and Disability Index (SPADI) score', 'pain and disability per dollar spent', 'Baseline SPADI score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}]",[],"[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",98.0,0.22955,Neither the number of visits nor the financial cost of nonsurgical shoulder- related care was associated with improvement in shoulder pain and disability at 1 year.  ,"[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Clewley', 'Affiliation': ''}, {'ForeName': 'Yusra', 'Initials': 'Y', 'LastName': 'Iftikhar', 'Affiliation': ''}, {'ForeName': 'Maggie E', 'Initials': 'ME', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9440']
1482,33132076,[Effect of a hemodialysis patient education on fluid control and dietary].,"INTRODUCTION


Most chronic hemodialysis patients do not adhere to diet and fluid restrictions, source of clinical complications in the medium and long term, in some cases fatal, this study was conducted to investigate the effect of the training program given to these patients on their adherence to diet and fluid restrictions.
MATERIALS AND METHODS


The study was conducted with 50 people, split into 2 groups, set up on a control group with 25 people. No education program has been set up, and the second group with 25 people assigned to the intervention having received an education program. Data were collected using the sociodemographic characteristics questionnaire, dialysis diet and fluid non-adherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS).
RESULTS


The measurements made at the end of the education program revealed a statistically significant difference in favor of the intervention group in terms of the mean values for the patients interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure. Similarly, the means of the scores for the 4 items of the DDFQ questionnaire revealed a statistically significant difference in favor of the intervention group concerning: the frequency of non-adherence to the diet, the degree of non-adherence to the diet, the frequency of non-adherence to liquid restriction and the degree of non-adherence to liquid restriction.
CONCLUSION


This monocentric work shows that the establishment of an educational program has a positive impact on patients adherence to dietary measures and restriction of fluids.",2020,"The measurements made at the end of the education program revealed a statistically significant difference in favor of the intervention group in terms of the mean values for the patients interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure.","['50\xa0people, split into 2\xa0groups, set up on a control group with 25\xa0people', 'chronic hemodialysis patients']","['intervention having received an education program', 'hemodialysis patient education']","['frequency of non-adherence', 'interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure', 'sociodemographic characteristics questionnaire, dialysis diet and fluid non-adherence questionnaire (DDFQ), and fluid control in hemodialysis patients scale (FCHPS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0336604', 'cui_str': 'Patient scale'}]",,0.0201552,"The measurements made at the end of the education program revealed a statistically significant difference in favor of the intervention group in terms of the mean values for the patients interdialytic weight gain (kg), ultrafilration volume and diastolic blood pressure.","[{'ForeName': 'Abderrahim', 'Initials': 'A', 'LastName': 'Nadri', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc. Electronic address: abderrahimnadri@gmail.com.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Khanoussi', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Hssaine', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Chettati', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Wafaa', 'Initials': 'W', 'LastName': 'Fadili', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}, {'ForeName': 'Inass', 'Initials': 'I', 'LastName': 'Laouad', 'Affiliation': 'Service de néphrologie, hémodialyse et transplantation rénale, CHU Mohamed VI, 40000 Marrakech, Maroc.'}]",Nephrologie & therapeutique,['10.1016/j.nephro.2020.03.011']
1483,33133178,Personality Differences of Brain Networks in Placebo Analgesia and Nocebo Hyperalgesia: A Psychophysiological Interaction (PPI) Approach in fMRI.,"It is generally believed that the placebo response can elicit an analgesic effect, whilst the nocebo response can elicit a hyperalgesia effect in pain. Placebo analgesia and nocebo hyperalgesia effects are increasing concerns for researchers. Growing evidence suggests personality differences have an impact on both placebo and nocebo effects. However, previous studies have not reached a unified conclusion. We designed this study to explore the personality differences of functional magnetic resonance imaging (fMRI) signals in placebo response and nocebo response by using psychophysiological interaction (PPI) analysis. 30 healthy subjects underwent conditioning induction training to establish expectations of placebo effect and nocebo effect, and then, all subjects completed the following experimental procedures: (1) baseline scanning, (2) acute pain model establishment, (3) pain status scanning, and (4) pseudorandom scanning of block design of placebo response or nocebo response. Behavioral data were collected after each scan. The results of this study showed that (1) there were significant differences of VAS placebo intervention between the extrovert group and the introvert group ( p  = 0.004); (2) there were significant differences of VAS nocebo intervention between the extrovert group and the introvert group ( p  = 0.011); (3) there were significant differences between the VAS placebo intervention and VAS pain status (baseline) in both the extrovert group ( p  < 0.001) and the introvert group ( p  = 0.001); (4) there were significant differences between the VAS nocebo intervention and VAS pain status (baseline) in both the extrovert group ( p  = 0.008) and the introvert group ( p  < 0.001). Moreover, there were significant differences in the brain network for placebo and nocebo responses between different personalities. We found that (1) deactivation differences of the pain-related network and limbic system play an important role in personality differences associated with placebo analgesia and (2) differences of control of anxiety and activation of dorsolateral prefrontal cortex may cause the personality differences observed in nocebo hyperalgesia.",2020,"Moreover, there were significant differences in the brain network for placebo and nocebo responses between different personalities.","['30 healthy subjects underwent', 'and Nocebo Hyperalgesia']","['placebo response or nocebo response', 'Placebo Analgesia', 'placebo', 'conditioning induction training', 'Placebo']","['VAS placebo intervention and VAS pain status', 'VAS placebo intervention', 'VAS nocebo intervention', 'brain network', 'VAS nocebo intervention and VAS pain status', 'Behavioral data']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",30.0,0.272006,"Moreover, there were significant differences in the brain network for placebo and nocebo responses between different personalities.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Hongrui', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Guiyuan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation, Zhujiang Hospital, Southern Medical University, Guangzhou 510282, China.'}]",Neural plasticity,['10.1155/2020/8820443']
1484,33136301,Tailored music listening intervention to reduce sleep disturbances in older adults with dementia: Research protocol.,"Sleep disruption in older adults living with Alzheimer's disease and related dementias (ADRD) is debilitating and contributes to increased institutionalization, reduced cognitive function, and accelerated disease progression. Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden. Given the potentially harmful side effects of pharmacologic treatment, nonpharmacologic approaches, such as music, may provide a safer alternative to reducing sleep disruption in this vulnerable population. A growing body of literature suggests that calming tailored music may improve sleep quality in older adults with memory loss, but its efficacy has not been demonstrated in older adults with ADRD in the community, where most older adults with ADRD live. If shown to be feasible and acceptable, tailored music interventions can then be tested for efficacy in reducing sleep disruption. This protocol details a wait-list randomized controlled trial (NCT04157244), the purpose of which is to test the feasibility, acceptability, and examine the preliminary efficacy of a tailored music listening intervention in older adults with ADRD who report sleep disruption. Music selections will be tailored to the music genre preferences of older adults with ADRD and account for known sleep-inducing properties. The feasibility of processes that is key to the success of the subsequent study will be examined. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective (proxy-reported) sleep quality measures. In addition, qualitative data will be solicited, examining the acceptability and satisfaction with the intervention by individuals with ADRD.",2020,"Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden.","['older adults with ADRD', 'older adults with memory loss', ""older adults living with Alzheimer's disease and related dementias (ADRD"", 'older adults with dementia', 'older adults with ADRD live', 'older adults with ADRD who report sleep disruption']","['tailored music listening intervention', 'Tailored music listening intervention']","['acceptability and satisfaction', 'objective (actigraphy) and subjective (proxy-reported) sleep quality measures', 'sleep disturbances', 'Sleep disruption', 'sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002622', 'cui_str': 'Amnesia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.086478,"Furthermore, sleep disruption is linked to poor health outcomes in caregivers, such as decreased quality of life and increased caregiver burden.","[{'ForeName': 'Darina V', 'Initials': 'DV', 'LastName': 'Petrovsky', 'Affiliation': 'Behavioral Health Sciences Department, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nalaka S', 'Initials': 'NS', 'LastName': 'Gooneratne', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Bradt', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Hodgson', 'Affiliation': 'Behavioral Health Sciences Department, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}]",Research in nursing & health,['10.1002/nur.22081']
1485,33131095,Pharmacodynamics of tegoprazan and revaprazan after single and multiple oral doses in healthy subjects.,"BACKGROUND


Potassium-competitive acid blockers (P-CABs) are emerging as novel treatments for acid-related disorders including gastroesophageal reflux disease. Tegoprazan and revaprazan are approved P-CABs in South Korea, but the pharmacodynamics and safety/tolerability of the two drugs have never been compared.
AIMS


To evaluate the pharmacodynamics and safety/tolerability of tegoprazan and revaprazan after single and multiple oral doses METHODS: A randomised, open-label, active-controlled study was conducted in Helicobacter pylori-negative healthy Korean male subjects. Tegoprazan 50 mg or revaprazan 200 mg was administered orally, once daily for 7 days; 24-h intragastric pH monitoring and serum gastrin were measured for pharmacodynamic evaluation. Safety parameters including serum microRNA-122 (miR-122) level were also collected.
RESULTS


After a single dose, the %Time pH ≥4 for tegoprazan was greater than that for revaprazan (54.5% vs 25.1%). After multiple doses, the %Time pH ≥4 for tegoprazan was also greater than that for revaprazan (68.2% vs 25.3%). %Time pH ≥4 during 12 hours at nighttime for tegoprazan was greater than that for revaprazan (71.8% vs 31.9%). The changes in the serum gastrin were not clinically significant for either drug. Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.
CONCLUSION


Tegoprazan 50 mg showed stronger gastric acid suppression than revaorazan 200 mg. Both drugs were well tolerated.",2020,"Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.
","['Helicobacter pylori-negative healthy Korean male subjects', 'healthy subjects']","['revaprazan', 'Tegoprazan and revaprazan', 'tegoprazan and revaprazan', 'Potassium-competitive acid blockers (P-CABs', 'Tegoprazan 50\xa0mg or revaprazan', 'revaorazan', 'Tegoprazan']","['serum gastrin', 'Time pH ≥4 for tegoprazan', 'serum miR-122', 'tolerated', 'serum microRNA-122 (miR-122) level', 'gastric acid suppression', 'pharmacodynamics and safety/tolerability']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2699073', 'cui_str': 'Revaprazan'}, {'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4726822', 'cui_str': 'tegoprazan'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017119', 'cui_str': 'Gastric acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0348469,"Despite the slight increases of serum miR-122 for each drug, tegoprazan and revaprazan were well tolerated considering other safety parameters including AST and ALT levels.
","[{'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Chun', 'Initials': 'SC', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Mu Seong', 'Initials': 'MS', 'LastName': 'Ban', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Nam', 'Affiliation': 'Division of Clinical Development, HK inno.N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Bongtae', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Division of Clinical Development, HK inno.N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Geun Seog', 'Initials': 'GS', 'LastName': 'Song', 'Affiliation': 'Division of Clinical Development, HK inno.N Corp., Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16121']
1486,33135666,Effects of a Combination of Three-Dimensional Virtual Reality and Hands-on Horticultural Therapy on Institutionalized Older Adults' Physical and Mental Health: Quasi-Experimental Design.,"BACKGROUND


Institutionalized older adults have limited ability to engage in horticultural activities that can improve their physical and mental health.
OBJECTIVE


This study explored the effects of a combination of 3D virtual reality and horticultural therapy on institutionalized older adults' physical and mental health.
METHODS


The study used a quasi-experimental design. A total of 106 older adults from 2 long-term care facilities were recruited and assigned to the experimental (n=59) or control (n=47) group. The experimental participants received a 9-week intervention. Both groups completed 3 assessments: at baseline, after the intervention, and 2 months later. The outcome variables included health status, meaning in life, perceived mattering, loneliness, and depression.
RESULTS


The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months.
CONCLUSIONS


This study verified the beneficial effects of a combination of 3D virtual reality and hands-on horticultural therapy on older adults' health. These results could support the future successful implementation of similar programs for institutionalized older adults on a larger scale.",2020,"The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months.
","['institutionalized older adults', '106 older adults from 2 long-term care facilities were recruited and assigned to the experimental (n=59) or control (n=47) group', ""institutionalized older adults' physical and mental health"", ""Institutionalized Older Adults' Physical and Mental Health"", ""older adults' health"", 'Institutionalized older adults']","['Combination of Three-Dimensional Virtual Reality and Hands-on Horticultural Therapy', '3D virtual reality and horticultural therapy', '3D virtual reality and hands-on horticultural therapy']","['reduced depression (P<.001) and loneliness', 'health status, meaning in life, perceived mattering, loneliness, and depression', 'health status (P<.001), meaning in life']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0454057', 'cui_str': 'Horticultural therapy'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",106.0,0.0289225,"The experimental group demonstrated significantly improved health status (P<.001), meaning in life (P<.001), and perceived mattering (P<.001) as well as significantly reduced depression (P<.001) and loneliness (P<.001) compared to the control group immediately after the intervention; these effects persisted for up to 2 months.
","[{'ForeName': 'Tsung-Yi', 'Initials': 'TY', 'LastName': 'Lin', 'Affiliation': 'Department of Marketing and Distribution Management, Hsing Wu University, Taipei, Taiwan.'}, {'ForeName': 'Chiu-Mieh', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Pei', 'Initials': 'HP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Clinical Nursing, School of Nursing, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jung-Yu', 'Initials': 'JY', 'LastName': 'Liao', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan.'}, {'ForeName': 'Vivian Ya-Wen', 'Initials': 'VY', 'LastName': 'Cheng', 'Affiliation': 'PureAroma Healing Academy, Taipei, Taiwan.'}, {'ForeName': 'Shih-Wen', 'Initials': 'SW', 'LastName': 'Wang', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Jong-Long', 'Initials': 'JL', 'LastName': 'Guo', 'Affiliation': 'Department of Health Promotion and Health Education, College of Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Journal of medical Internet research,['10.2196/19002']
1487,33106049,Comparison Between Optical Frequency Domain Imaging and Intravascular Ultrasound for Percutaneous Coronary Intervention Guidance in Biolimus A9-Eluting Stent Implantation: A Randomized MISTIC-1 Non-Inferiority Trial.,"BACKGROUND


Given the characteristic differences between intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), their approach to therapeutic guidance during percutaneous coronary interventions (PCIs) and arterial healing response after stenting may also vary.
METHODS


MISTIC-1 (The Multimodality Imaging Study in Cardiology cohort 1) is a multicenter, randomized-controlled, noninferiority trial that compared imaging end points between OFDI- and IVUS-guided PCI. Patients with stable coronary artery disease were randomly assigned to either OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance. Stent sizing was based on external elastic lamina in IVUS-guided PCI while lumen up-size in OFDI-guided PCI. Postprocedural OFDI was investigated regardless of randomization, while operators in IVUS-guided PCI arm were blinded to the images. The primary end point was in-segment minimum lumen area assessed using OFDI at 8 months, while the secondary end point was a composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point). Patients were followed up to 3 years after the index procedure.
RESULTS


A total of 109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled. Postprocedural minimum stent area was 6.31±1.89 and 6.72±2.08 mm 2  in OFDI and IVUS group, respectively ( P =0.26). At the 8-month follow-up, in-segment minimum lumen area was 4.56±1.94 and 4.13±1.86 mm 2  in OFDI and IVUS group, respectively ( P non-inferiority  <0.001). Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively;  P =0.43). The incidence rate of device-oriented composite end point at 3 years was 7.4% and 7.3% in OFDI and IVUS group, respectively (hazard ratio, 1.05 [95% CI, 0.26-4.18];  P =0.95).
CONCLUSIONS


OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was acknowledged, OFDI could be an alternative to IVUS when considering intracoronary imaging-guided PCI in selected populations with coronary artery diseases. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03292081.",2020,"Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively;  P =0.43).","['109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled', 'Patients with stable coronary artery disease']","['intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI', 'OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance', 'OFDI- and IVUS-guided PCI', 'Stent Implantation', 'Optical Frequency Domain Imaging and Intravascular Ultrasound']","['composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point', 'Postprocedural OFDI', 'Postprocedural minimum stent area', 'segment minimum lumen area assessed using OFDI', 'incidence rate of device-oriented composite end point', 'neointimal healing score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4310325', 'cui_str': 'Biolimus A9'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",109.0,0.122019,"Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00-3.14] versus 0.90 [0.00-3.30], respectively;  P =0.43).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': 'Department of Cardiology, Cardiovascular Center (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiology, Fujita Health University Okazaki Medical Center, Japan (Y.O., Y.H., Y. Yoshiki).'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Nanasato', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan (M.N.).'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Cardiology, Cardiovascular Center (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Cardiology, Cardiovascular Center (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Ohota', 'Affiliation': 'Department of Cardiology, Cardiovascular Center (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Cardiology, Fujita Health University Okazaki Medical Center, Japan (Y.O., Y.H., Y. Yoshiki).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yoshiki', 'Affiliation': 'Department of Cardiology, Fujita Health University Okazaki Medical Center, Japan (Y.O., Y.H., Y. Yoshiki).'}, {'ForeName': 'Hidemaro', 'Initials': 'H', 'LastName': 'Takatsu', 'Affiliation': 'Department of Cardiology, Cardiovascular Center (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Radiology (K.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kamiya', 'Affiliation': 'Department of Cardiovascular Medicine, Gifu Heart Center, Japan (H.K.).'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Japanese Red Cross Nagoya Daini Hospital, Japan (Y. Yoshida).'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Japan (T.M.).'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Izawa', 'Affiliation': 'Department of Cardiology, Cardiovascular Center (T. Muramatsu, M.I., R.N., M.O., H.T., H.I.), Fujita Health University Hospital, Toyoake, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009314']
1488,33111605,The Effects of Case-Based Teaching in Nursing Skill Education: Cases Do Matter.,"Nursing skill education plays a very important part for the nursing education. It's necessary to analyze the role of the case-based teaching (CBT) in nursing skill education, to provide insights into the nursing education. The sophomore nursing students who received nursing skill teaching from September 2019 to January 2020 were selected. The students either underwent traditional teaching (control group) or CBT (CBT group) intervention. The objective structure clinical examination (OSCE), autonomous learning ability, questionnaire for effects evaluation of CBT, and student's satisfaction level on CBT were analyzed. A total of 146 participants were included. There were no significant differences in the gender, age and the final exam score as freshman between 2 groups (all  P  > .05). The OSCE scores and autonomous learning ability in CBT group were significantly higher than that of control group (all  P  < .05). The most students favored the use of CBT, and most students were satisfied with CBT. CBT is beneficial to improve the nursing skill and comprehensive ability of students, and it's conducive to increase the interest of students, which merits application in nursing education.",2020,The OSCE scores and autonomous learning ability in CBT group were significantly higher than that of control group (all  P  < .05).,"['A total of 146 participants were included', 'sophomore nursing students who received nursing skill teaching from September 2019 to January 2020 were selected']","['CBT', 'traditional teaching (control group) or CBT (CBT group) intervention', 'Case-Based Teaching']",['OSCE scores and autonomous learning ability'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",146.0,0.0119905,The OSCE scores and autonomous learning ability in CBT group were significantly higher than that of control group (all  P  < .05).,"[{'ForeName': 'Lanfang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Health Vocational College, Nanchang, China.'}, {'ForeName': 'Mengqian', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Jiangxi Health Vocational College, Nanchang, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Jinggangshan University, Ji'an, Jiangxi, China.""}]","Inquiry : a journal of medical care organization, provision and financing",['10.1177/0046958020964421']
1489,33118955,Web-Based Training for Nurses on Shared Decision Making and Prenatal Screening for Down Syndrome: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Pregnant women often find it difficult to choose from among the wide variety of available prenatal screening options. To help pregnant women and their partners make informed decisions based on their values, needs, and preferences, a decision aid and a web-based shared decision making (SDM) training program for health professionals have been developed. In Canada, nurses provide maternity care and thus can train as decision coaches for prenatal screening. However, there is a knowledge gap about the effectiveness of SDM interventions in maternity care in nursing practice.
OBJECTIVE


This study aims to assess the impact of an SDM training program on nurses' intentions to use a decision aid for prenatal screening and on their knowledge and to assess their overall impressions of the training.
METHODS


This is a 2-arm parallel randomized trial. French-speaking nurses working with pregnant women in the province of Quebec were recruited online by a private survey firm. They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone. The experimental intervention consisted of a 3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2) Down syndrome prenatal screening; (3) decision aids; and (4) communication between health care professionals and the patient. For the control group, the topic of SDM in Module 1 was replaced with ""Context and history of prenatal screening,"" and the topic of decision aids in Module 3 was replaced with ""Consent in prenatal screening."" Participants completed a self-administered sociodemographic questionnaire with close-ended questions. We also assessed the participants' (1) intention to use a decision aid in prenatal screening clinical practice, (2) knowledge, (3) satisfaction with the training, (4) acceptability, and (5) perceived usefulness of the training. The randomization was done using a predetermined sequence and included 40 nurses. Participants and researchers were blinded. Intention to use a decision aid will be assessed by a t test. Bivariate and multivariate analysis will be performed to assess knowledge and overall impressions of the training.
RESULTS


This study was funded in 2017 and approved by Genome Canada. Data were collected from September 2019 to late January 2020. This paper was initially submitted before data analysis began. Results are expected to be published in winter 2020.
CONCLUSIONS


Study results will inform us on the impact of an SDM training program on nurses' intention to use and knowledge of decision aids for prenatal screening and their overall impressions of the training. Participant feedback will also inform an upgrade of the program, if needed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04162288; https://clinicaltrials.gov/ct2/show/NCT04162288.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17878.",2020,"They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone.","['French-speaking nurses working with pregnant women in the province of Quebec', 'Pregnant women', 'Data were collected from September 2019 to late January 2020']","['SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone', 'SDM interventions', '3-hour web-based training hosted on the Université Laval platform with 4 modules: (1) SDM; (2', 'SDM training program']",[],"[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0543432', 'cui_str': 'Problem solving training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0740178', 'cui_str': 'Antenatal screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",[],,0.112048,"They were randomly allocated (1:1 ratio) to either an experimental group, which completed a web-based SDM training program that included prenatal screening, or a control group, which completed a web-based training program focusing on prenatal screening alone.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Poulin Herron', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Titilayo Tatiana', 'Initials': 'TT', 'LastName': 'Agbadje', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Cote', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Codjo Djignefa', 'Initials': 'CD', 'LastName': 'Djade', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Roch', 'Affiliation': 'Centre de recherche en santé durable (VITAM), Québec, QC, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Rousseau', 'Affiliation': ""Centre Hospitalier Universitaire de Québec - Université Laval Research Centre, Hôpital Saint-François d'Assise, Québec City, QC, Canada.""}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'Canada Research Chair in Shared Decision Making and Knowledge Translation, Université Laval, Québec, QC, Canada.'}]",JMIR research protocols,['10.2196/17878']
1490,33118956,Relationship Between Patient Engagement and Depressive Symptoms Among People Living With HIV in a Mobile Health Intervention: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Associations between higher levels of patient engagement and better health outcomes have been found in face-to-face interventions; studies on such associations with mobile health (mHealth) interventions have been limited and the results are inconclusive.
OBJECTIVE


The objective of this study is to investigate the relationship between patient engagement in an mHealth intervention and depressive symptoms using repeated measures of both patient engagement and patient outcomes at 4 time points.
METHODS


Data were drawn from a randomized controlled trial (RCT) of an mHealth intervention aimed at reducing depressive symptoms among people living with HIV and elevated depressive symptoms. We examined the association between patient engagement and depressive symptoms in the intervention group (n=150) where participants received an adapted cognitive-behavioral stress management (CBSM) course and physical activity promotion on their WeChat social media app. Depressive symptoms were repeatedly measured using the Patient Health Questionnaire (PHQ-9) at baseline and 1 month, 2 months, and 3 months. Patient engagement was correspondingly measured by the completion rate, frequency of items completed, and time spent on the program at 1 month, 2 months, and 3 months. Latent growth curve models (LGCMs) were used to explore the relationship between patient engagement and depressive symptoms at multiple time points in the intervention.
RESULTS


The mean PHQ-9 scores were 10.2 (SD 4.5), 7.7 (SD 4.8), 6.5 (SD 4.7), and 6.7 (SD 4.1) at baseline, 1 month, 2 months, and 3 months, respectively. The mean completion rates were 50.6% (SD 31.8%), 51.5% (SD 32.2%), and 50.8% (SD 33.7%) at 1, 2, and 3 months, respectively; the average frequencies of items completed were 18.0 (SD 14.6), 32.6 (SD 24.8), and 47.5 (SD 37.2) at 1, 2, and 3 months, respectively, and the mean times spent on the program were 32.7 (SD 66.7), 65.4 (SD 120.8), and 96.4 (SD 180.4) minutes at 1, 2, and 3 months, respectively. LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=-2.184, P=.048) and a greater frequency of items completed (β at 3 months=-0.018, P=.04) were associated with fewer depressive symptoms at 3 months. Although not significant, similar trends were found in the abovementioned relationships at 1 and 2 months. There was no significant relationship between time spent on the program and depressive symptoms.
CONCLUSIONS


This study revealed a positive association between patient engagement and health outcomes at 3 months of an mHealth intervention using LGCMs and repeated measures data. The results underscore the importance of improving patient engagement in mHealth interventions to improve patient-centered health outcomes.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IPR-17012606; https://tinyurl.com/yxb64mef.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12889-018-5693-1.",2020,"LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=-2.184, P=.048) and a greater frequency of items completed (β at 3 months=-0.018, P=.04) were associated with fewer depressive symptoms at 3 months.","['people living with HIV and elevated depressive symptoms', 'People Living With HIV in a Mobile Health Intervention']","['adapted cognitive-behavioral stress management (CBSM) course and physical activity promotion on their WeChat social media app', 'mHealth intervention']","['time spent on the program and depressive symptoms', 'Patient Health Questionnaire (PHQ-9', 'mean times spent on the program', 'completion rate, frequency of items completed, and time spent', 'depressive symptoms', 'higher completion rate', 'Depressive symptoms', 'mean PHQ-9 scores', 'mean completion rates']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.109046,"LGCMs showed good model fit and indicated that a higher completion rate (β at 3 months=-2.184, P=.048) and a greater frequency of items completed (β at 3 months=-0.018, P=.04) were associated with fewer depressive symptoms at 3 months.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Y Alicia', 'Initials': 'YA', 'LastName': 'Hong', 'Affiliation': 'Department of Health Administration and Policy, College of Health and Human Services, George Mason University, Fairfax, VA, United States.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center of Healthcare Quality, Arnold School of Public Health, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Hanxi', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Center of AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Diseases, Guangzhou Number Eight People's Hospital, Guangzhou, China.""}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Peilian', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Psychology, Faculty of Social Sciences, University of Macau, Macau, China.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Monroe-Wise', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Yuantao', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rainbow Tin Hung', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong, China.'}]",JMIR mHealth and uHealth,['10.2196/20847']
1491,33113211,Strength training restores force-generating capacity in patients with schizophrenia.,"Patients with schizophrenia spectrum disorders have impaired skeletal muscle force-generating capacity (FGC) of the lower extremities, that is, one repetition maximum (1RM) and rapid force development, and poor functional performance. We therefore investigated whether 12 weeks of maximal strength training (MST) could (a) restore FGC and functional performance to the level of healthy references, (b) increase patient activation and quality of life, and (c) explore associations between symptom severity, defined daily dose of medication, illness duration, level of patient activation, and improvements in FGC and functional performance. Forty-eight outpatients were randomized to a training group (TG) or control group (CG). TG performed leg press MST 2 day/week at ~ 90% 1RM. The CG received two introductory training sessions and encouragement to train independently. Leg press 1RM, rapid force development, a battery of functional performance tests, Patient Activation Measure-13, and 36-Item Short Form Health Survey were tested. Healthy references performed baseline tests of FGC and functional performance. Thirty-six patients completed the study (TG: 17, CG: 19). TG improved 1RM (28%) and rapid force development (20%, both P < .01) to a level similar to healthy references, while no change was apparent in the CG. TG's improvement in rapid force development was negatively associated with defined daily dose of medication (r = -0.5, P = .05). Both TG and CG improved 30-second sit-to-stand test performance (P < .05) which was associated with improved rapid force development (r = 0.6, P < .05). In conclusion, 12 weeks of MST restored patients' lower extremity FGC to a level similar to healthy references and improved 30-second sit-to-stand test performance.",2020,"TG improved 1RM (28%) and rapid force development (20%, both p<0.01) to a level similar to healthy references, while no change was apparent in the CG.","['patients with schizophrenia', 'Patients with schizophrenia spectrum disorders', 'Thirty-six patients completed the study (TG: 17, CG: 19', 'Forty-eight outpatients']","['training group (TG) or control group (CG', 'Strength training', 'maximal strength training (MST', 'MST']","['patient activation and quality of life, and (3) explore associations between symptom severity, defined daily dose of medication, illness duration, level of patient activation and improvements in FGC and functional performance', 'TG improved 1RM', 'extremity FGC', 'rapid force development', 'Leg press 1RM, rapid force development, a battery of functional performance tests, Patient Activation Measure-13 and 36-Item Short Form Health Survey']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",48.0,0.0194043,"TG improved 1RM (28%) and rapid force development (20%, both p<0.01) to a level similar to healthy references, while no change was apparent in the CG.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mathias Forsberg', 'Initials': 'MF', 'LastName': 'Brobakken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Joshua Landen', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Solveig Klaebo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Ismail Cüneyt', 'Initials': 'IC', 'LastName': 'Güzey', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Vedul-Kjelsås', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Heggelund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13863']
1492,33113295,SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19.,"BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (Covid-19), which is most frequently mild yet can be severe and life-threatening. Virus-neutralizing monoclonal antibodies are predicted to reduce viral load, ameliorate symptoms, and prevent hospitalization.
METHODS


In this ongoing phase 2 trial involving outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a single intravenous infusion of neutralizing antibody LY-CoV555 in one of three doses (700 mg, 2800 mg, or 7000 mg) or placebo and evaluated the quantitative virologic end points and clinical outcomes. The primary outcome was the change from baseline in the viral load at day 11. The results of a preplanned interim analysis as of September 5, 2020, are reported here.
RESULTS


At the time of the interim analysis, the observed mean decrease from baseline in the log viral load for the entire population was -3.81, for an elimination of more than 99.97% of viral RNA. For patients who received the 2800-mg dose of LY-CoV555, the difference from placebo in the decrease from baseline was -0.53 (95% confidence interval [CI], -0.98 to -0.08; P = 0.02), for a viral load that was lower by a factor of 3.4. Smaller differences from placebo in the change from baseline were observed among the patients who received the 700-mg dose (-0.20; 95% CI, -0.66 to 0.25; P = 0.38) or the 7000-mg dose (0.09; 95% CI, -0.37 to 0.55; P = 0.70). On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo. The percentage of patients who had a Covid-19-related hospitalization or visit to an emergency department was 1.6% in the LY-CoV555 group and 6.3% in the placebo group.
CONCLUSIONS


In this interim analysis of a phase 2 trial, one of three doses of neutralizing antibody LY-CoV555 appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).",2020,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","['outpatients with recently diagnosed mild or moderate Covid-19, we randomly assigned 452 patients to receive a', 'Outpatients with Covid-19']","['placebo', 'single intravenous infusion of neutralizing antibody LY-CoV555']","['severity of symptoms', 'viral load', 'Covid-19-related hospitalization or visit to an emergency department']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",452.0,0.572537,"On days 2 to 6, the patients who received LY-CoV555 had a slightly lower severity of symptoms than those who received placebo.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boscia', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cardona', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Mocherla', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Stosor', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Imad', 'Initials': 'I', 'LastName': 'Shawa', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Adams', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Van Naarden', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Custer', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Oakley', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Schade', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Sabo', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Dipak R', 'Initials': 'DR', 'LastName': 'Patel', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Skovronsky', 'Affiliation': ""From the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - both in California; Eli Lilly, Indianapolis (A.N., A.C.A., J.V.N., K.L.C., L.S., M.D., G.O., A.E.S., J.S., D.R.P., P.K., D.M.S.), and Franciscan Health, Greenwood (I.S.) - both in Indiana; Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.); Vitalink Research, Union, SC (J.B.); Imperial Health, Lake Charles, LA (J.M.); Cook County Health (G.H.) and Northwestern University Feinberg School of Medicine (V.S.), Chicago; Indago Research and Health Center, Hialeah, FL (J.C.); and Las Vegas Medical Research Center, Las Vegas (B.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029849']
1493,33124984,Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial.,"BACKGROUND


Mental health disorders are the most prevalent health issues among postsecondary students, yet few solutions to this emerging crisis exist. While mobile health technologies are touted as promising solutions for the unmet mental health needs of these students, the efficacy of these tools remains unclear. In response to these gaps, this study evaluates Thought Spot, a mobile and web app created through participatory design research.
OBJECTIVE


The goal of the research is to examine the impact of Thought Spot on mental health and wellness help-seeking intentions, behaviors, attitudes, self-stigma, and self-efficacy among postsecondary students in Canada.
METHODS


A 2-armed randomized controlled trial involving students from three postsecondary institutions was conducted. Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device. The usual care group received a mental health services information pamphlet. The intervention group received the Thought Spot app on their digital device. Thought Spot is a standalone app that allows users to add, review, and search crowdsourced information about nearby mental health and wellness services. Users can also track their mood on the app. Outcomes were self-assessed through questionnaires collected at baseline and 3 and 6 months. The primary outcome was change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire. A mixed-effects model was used to compare the impact of usual care and intervention on the primary outcome (formal help-seeking intentions). Secondary outcomes included changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy.
RESULTS


A total of 481 students were randomized into two groups: 240 to usual care, and 241 to the intervention group. There were no significant differences in help-seeking intentions between the usual care and intervention groups over 6 months (F 2,877 =0.85; P=.43, f=0.04). Both groups demonstrated similar increases in formal help-seeking intentions at 3 and 6 months (F 2,877 =23.52; P<.001, f=0.21). Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001). Females were less likely to seek help from informal sources than males (OR 0.80; 95% CI 0.22 to 0.73, P<.001).
CONCLUSIONS


Prompting postsecondary students about mental health and help-seeking appears to increase help-seeking intentions. mHealth interventions may be as effective as information pamphlets in increasing formal help-seeking but may confer a small advantage in driving help-seeking from informal sources. Although there is enthusiasm, developers and health policy experts should exercise caution and thoroughly evaluate these types of digital tools. Future studies should explore the cost-effectiveness of digital interventions and develop strategies for improving their efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03412461; https://clinicaltrials.gov/ct2/show/NCT03412461.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.6446.",2020,"Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001).","['students from three postsecondary institutions was conducted', 'A total of 481 students', 'Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device', 'postsecondary students in Canada', 'Mental Health Help-Seeking Among College and University Students']","['mental health services information pamphlet', 'Mobile and Web App (Thought Spot', 'Thought Spot app on their digital device']","['help-seeking intentions', 'formal help-seeking intentions', 'change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire', 'changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0682294', 'cui_str': 'Part-time employment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683301', 'cui_str': 'Help-Seeking Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",481.0,0.160705,"Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, P=.001).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wiljer', 'Affiliation': 'UHN Digital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'UHN Digital, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanches', 'Affiliation': 'Krembil Centre for Neuroinformatics, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Hollenberg', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Alexxa', 'Initials': 'A', 'LastName': 'Abi-Jaoudé', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Chaim', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Robb', 'Affiliation': 'Health and Wellness, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Howard W', 'Initials': 'HW', 'LastName': 'Wong', 'Affiliation': 'Office of Education, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Aristotle', 'Initials': 'A', 'LastName': 'Voineskos', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Journal of medical Internet research,['10.2196/20790']
1494,33124987,Effectiveness of a Peer-Led Web-Based Intervention to Improve General Self-Efficacy in Using Dating Apps Among Young Adults: Randomized Clustered Trial.,"BACKGROUND


Online dating apps are popular platforms for seeking romance and sexual relationships among young adults. As mobile apps can easily gain access to a pool of strangers (""new friends"") at any time and place, it leads to heightened sexual health risks and privacy concerns.
OBJECTIVE


This study aimed to evaluate the effectiveness of a peer-led web-based intervention for online dating apps to prepare Chinese college students so that they have better self-efficacy when using dating apps.
METHODS


An open clustered randomized controlled trial was conducted among students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong. Students aged 17 to 27 years who attended common core curriculum or general education were randomized into intervention and control groups. The intervention material, developed with high peer engagement, included four short videos, an interactive scenario game, and a risk assessment tool. An existing website promoting physical activities and healthy living was used as a control. Using the information, motivation, and behavioral skills (IMB) approach to design the evaluation, questionnaires covering participants' sociodemographics and dating app characteristics, as well as the general self-efficacy scale (GSE) as the primary outcome and the risk propensity scale (RPS) as the secondary outcome were administered before, immediately after, and at 1 month after the intervention. Intention-to-treat analysis was adopted, and between-group differences were assessed using the Mann-Whitney U test. A post-hoc multiple linear regression model was used to examine the correlates of the GSE and RPS.
RESULTS


A total of 578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up. There were more female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students. Over half of the participants (286/542, 52.8%) reported the following reasons for using dating apps: being curious (170/498, 34.1%), trying to make new friends (158/498, 31.7%), and finding friends with similar interests (121/498, 24.3%). Overall, the participants in the intervention group reported favorable experiences when compared with the finding in the control group. There was significant improvement in the GSE score and reduction in the RPS score (P<.001) in the intervention group. University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
CONCLUSIONS


The online intervention was effective in improving general self-efficacy and reducing risk tendency among young students. Future work is needed to determine if this approach is cost-effective and such behavioral change is sustainable.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03685643; https://clinicaltrials.gov/ct2/show/NCT03685643.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-018-3167-5.",2020,"University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
","['Young Adults', 'young adults', '578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up', 'female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students', 'young students', 'Chinese college students', 'students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong', 'Students aged 17 to 27 years who attended common core curriculum or general education']","['peer-led web-based intervention', 'Peer-Led Web-Based Intervention']","['GSE score', 'general self-efficacy', 'RPS score', 'risk reduction', 'risk propensity scale (RPS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0544691', 'cui_str': 'Hanging'}, {'cui': 'C0204116', 'cui_str': 'Vocational training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",578.0,0.0906271,"University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions.
","[{'ForeName': 'William Cw', 'Initials': 'WC', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Wai Han', 'Initials': 'WH', 'LastName': 'Sun', 'Affiliation': 'Sticky Rice Love Ltd., Hong Kong, China.'}, {'ForeName': 'Shu Ming Cheryl', 'Initials': 'SMC', 'LastName': 'Chia', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill - Project China, Guangzhou, China.'}, {'ForeName': 'William Ph', 'Initials': 'WP', 'LastName': 'Mak', 'Affiliation': 'Vocational Training Council, Hong Kong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Communication, Faculty of Social Sciences, University of Macau, Macau, Macao.'}, {'ForeName': 'Kitty Wai Ying', 'Initials': 'KWY', 'LastName': 'Choi', 'Affiliation': 'Sticky Rice Love Ltd., Hong Kong, China.'}, {'ForeName': 'Stephanie Tsz Hei', 'Initials': 'STH', 'LastName': 'Lau', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Eric Yuk Fai', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, University of Hong Kong, Hong Kong, China.'}]",Journal of medical Internet research,['10.2196/16378']
1495,33124989,"A Mobile App, KhunLook, to Support Thai Parents and Caregivers With Child Health Supervision: Development, Validation, and Acceptability Study.","BACKGROUND


In Thailand, children born in government hospitals receive a maternal and child health handbook (MCHH). However, when a new MCHH edition is released, those with the previous editions do not have access to the updated information. A mobile app is an appealing platform to fill this gap. We developed a mobile app called ""KhunLook"" as an interactive electronic MCHH intended to assist parents in child health supervision.
OBJECTIVE


This study describes the user requirements and development of the KhunLook mobile app, validity of parents' growth assessments, and parents' evaluation of feasibility and acceptability of the app.
METHODS


Phase 1 was a qualitative study using individual interviews. The interview data were used to revise the prototype. In phase 2, parents were randomly assigned to assess their children's growth with the app or the MCHH. The outcomes were compared to those of the physician's assessment, and congruence was determined. In phase 3, parents evaluated the feasibility and acceptability of the app in comparison to the MCHH through a web-based survey.
RESULTS


Four health care providers and 8 parents participated in phase 1. Two themes were identified: (1) the mobile app potentially counters parents' infrequent use of the MCHH with accuracy, attractiveness, convenience, and simplicity, and (2) health supervision needs to be standard, up-to-date, and understandable. KhunLook was publicly launched with a family page and 7 key features: growth and nutrition, development, immunizations, oral health, reminders for the next appointment, memories, and health advice. In phase 2, 56 parents participated in the growth parameter assessments; 34 were in the App group and 22 in the MCHH group. The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different. The congruence proportions were higher in the App group for weight and head circumference, but the differences were not statistically significant. In phase 3, 356 parents from all over Thailand participated in a web-based survey. Parents rated the app feasibility as ""very easy to easy"" to use at higher proportions than the MCHH in all health assessment domains (growth, development, and immunizations) and ease-of-use domains with statistical significance (P<.001). The KhunLook app received a significantly higher mean score (8.59/10) than the MCHH (7.6/10) (P<.001). Most parents (317/356, 89.0%) preferred the app over MCHH. Further, 93.5% (333/356) of the parents stated that they would continue to use the app and 96.9% (345/356) would recommend others to use it.
CONCLUSIONS


KhunLook, a Thai mobile app for child health supervision, was developed, validated for growth assessments, and was well accepted for ease-of-use by parents. Further studies should be conducted with a large scale of users, and the impact of this app on health behaviors and health outcomes must be evaluated.",2020,The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different.,"['356 parents from all over Thailand participated in a web-based survey', '56 parents participated in the growth parameter assessments; 34 were in the App group and 22 in the MCHH group', 'In Thailand, children born in government hospitals receive a maternal and child health handbook (MCHH']",[],"['MCHH with accuracy, attractiveness, convenience, and simplicity, and (2) health supervision needs', 'weight and head circumference', 'feasibility and acceptability']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1454365', 'cui_str': 'Simplicity (adhesive)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",356.0,0.0284046,The outcomes of the growth parameter assessments between parents and physicians in both the App and MCHH groups were not significantly different.,"[{'ForeName': 'Rosawan', 'Initials': 'R', 'LastName': 'Areemit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pagakrong', 'Initials': 'P', 'LastName': 'Lumbiganon', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chanyut', 'Initials': 'C', 'LastName': 'Suphakunpinyo', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Arunee', 'Initials': 'A', 'LastName': 'Jetsrisuparb', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sumitr', 'Initials': 'S', 'LastName': 'Sutra', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kunwadee', 'Initials': 'K', 'LastName': 'Sripanidkulchai', 'Affiliation': 'Department of Computer Engineering, Faculty of Engineering, Chulalongkorn University, Bangkok, Thailand.'}]",JMIR mHealth and uHealth,['10.2196/15116']
1496,33124994,A Web Application About Herd Immunity Using Personalized Avatars: Development Study.,"BACKGROUND


Herd immunity or community immunity refers to the reduced risk of infection among susceptible individuals in a population through the presence and proximity of immune individuals. Recent studies suggest that improving the understanding of community immunity may increase intentions to get vaccinated.
OBJECTIVE


This study aims to design a web application about community immunity and optimize it based on users' cognitive and emotional responses.
METHODS


Our multidisciplinary team developed a web application about community immunity to communicate epidemiological evidence in a personalized way. In our application, people build their own community by creating an avatar representing themselves and 8 other avatars representing people around them, for example, their family or coworkers. The application integrates these avatars in a 2-min visualization showing how different parameters (eg, vaccine coverage, and contact within communities) influence community immunity. We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library). Data included psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants' cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization's content and messaging.
RESULTS


Among 110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years. More than half (65/110, 59.0%) of participants reported having a university-level education. Iterative changes across the cycles included adding the ability for users to create their own avatars, specific signals about who was represented by the different avatars, using color and movement to indicate protection or lack of protection from infectious disease, and changes to terminology to ensure clarity for people with varying educational backgrounds. Overall, we observed 3 generalizable findings. First, visualization does indeed appear to be a promising medium for conveying what community immunity is and how it works. Second, by involving multiple users in an iterative design process, it is possible to create a short and simple visualization that clearly conveys a complex topic. Finally, evaluating users' emotional responses during the design process, in addition to their cognitive responses, offers insights that help inform the final design of an intervention.
CONCLUSIONS


Visualization with personalized avatars may help people understand their individual roles in population health. Our app showed promise as a method of communicating the relationship between individual behavior and community health. The next steps will include assessing the effects of the application on risk perception, knowledge, and vaccination intentions in a randomized controlled trial. This study offers a potential road map for designing health communication materials for complex topics such as community immunity.",2020,"We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library).","['110 participants across all four cycles, 68 (61.8%) were women and 38 (34.5%) were men (4/110, 3.6%; not reported), with a mean age of 38 (SD 17) years']",[],"['risk perception, knowledge, and vaccination intentions', ""psychophysiological measures (eye tracking, galvanic skin response, facial emotion recognition, and electroencephalogram) to assess participants' cognitive and affective responses to the visualization and verbal feedback to assess their interpretations of the visualization's content and messaging""]","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",110.0,0.0683283,"We predefined communication goals, created prototype visualizations, and tested four iterative versions of our visualization in a university-based human-computer interaction laboratory and community-based settings (a cafeteria, two shopping malls, and a public library).","[{'ForeName': 'Hina', 'Initials': 'H', 'LastName': 'Hakim', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bettinger', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Chambers', 'Affiliation': 'Department of Psychology and Neuroscience and Pediatrics, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'S Michelle', 'Initials': 'SM', 'LastName': 'Driedger', 'Affiliation': 'Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada, Winnipeg, MB, Canada.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Dubé', 'Affiliation': 'Institut national de santé publique du Québec, Institut national de santé publique du Québec, Quebec City, QC, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gavaruzzi', 'Affiliation': 'Department of Developmental Psychology and Socialization, University of Padova, Italy, Padova, Italy.'}, {'ForeName': 'Anik M C', 'Initials': 'AMC', 'LastName': 'Giguere', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Kavanagh', 'Affiliation': 'École de design, Édifice La Fabrique, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Leask', 'Affiliation': 'Faculty of Medicine and Health, Susan Wakil School of Nursing and Midwifery, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'MacDonald', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Orji', 'Affiliation': 'Faculty of Computer Science, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Parent', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Paquette', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Jacynthe', 'Initials': 'J', 'LastName': 'Roberge', 'Affiliation': 'École de design, Édifice La Fabrique, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Sander', 'Affiliation': 'University Health Network, Toronto General Hospital, Eaton Building, Toronto, ON, Canada.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Scherer', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa, IA, United States.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tremblay-Breault', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Kumanan', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Bruyere Research Institute and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Reinharz', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Holly O', 'Initials': 'HO', 'LastName': 'Witteman', 'Affiliation': 'Department of Family and Emergency Medicine, Laval University, Quebec City, QC, Canada.'}]",Journal of medical Internet research,['10.2196/20113']
1497,33124996,"Authors' Reply to: Comment on ""Facebook as a Novel Tool for Continuous Professional Education on Dementia: Pilot Randomized Controlled Trial"".",,2020,,[],[],[],[],[],[],,0.0646693,,"[{'ForeName': 'Windy Sy', 'Initials': 'WS', 'LastName': 'Chan', 'Affiliation': 'School of Health Sciences, Caritas Institute of Higher Education, New Territories, Hong Kong.'}, {'ForeName': 'Angela Ym', 'Initials': 'AY', 'LastName': 'Leung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Journal of medical Internet research,['10.2196/24084']
1498,33120777,The effect of acupuncture on depression and its correlation with metabolic alterations: A randomized controlled trial.,"BACKGROUND


Electroacupuncture (EA) treatment has antidepressant effect and when patients were treated with EA and antidepressants, the effect could be maintained for a longer time. However, the effect of EA combined with antidepressants based on metabolism is still in the initial observation stage, which requires further research.
METHODS


A total of 60 patients with moderate depression were assigned into 2 groups at a ratio of 1:1, the EA group (receiving EA and antidepressants) and the control group (taking antidepressants only) in this randomized controlled pilot trial. The EA treatment was performed 3 times a week for 8 consecutive weeks and then follow up for 4 weeks. The patients' depressive mood was measured by the Hamilton Depression scale (HAMD) at baseline, week 4, week 8 and week 12. Before and after 8-week treatment, morning urine samples from all patients were analyzed by the gas chromatography-mass spectrometry (GC-MS) to find possible metabolic markers of depression and of EA treatment related changes.
RESULTS


Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ± 5.74 vs 25.58 ± 7.03, P < .001), week 8 (9.59 ± 5.13 vs 25.04 ± 7.49, P < .001) and week 12 (11.07 ± 6.85 vs 27.25 ± 7.14, P < .001). The significant differences in urinary specific metabolites before and after EA treatment were malonic acid (fatty acid biosynthesis), cysteine (glutamate metabolism), glutathione (glutamate metabolism), tryptophan (tryptophan metabolism), proline (glutamate metabolism), and N-acetyl-5-hydroxytryptamine. These metabolites are involved in tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis.
CONCLUSION


EA treatment combined with antidepressants is more effective in improving depressive symptoms than antidepressants alone. EA may treat depression by acting on tryptophan metabolism, glutamate metabolism, and fatty acid biosynthesis.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR-2000030786.",2020,"Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ± 5.74 vs 25.58 ± 7.03, P < .001), week 8 (9.59 ± 5.13 vs 25.04 ± 7.49, P < .001) and week 12 (11.07 ± 6.85 vs 27.25 ± 7.14, P < .001).",['60 patients with moderate depression'],"['Electroacupuncture (EA', 'EA group (receiving EA and antidepressants', 'acupuncture']","['malonic acid (fatty acid biosynthesis), cysteine (glutamate metabolism), glutathione (glutamate metabolism), tryptophan (tryptophan metabolism), proline (glutamate metabolism), and N-acetyl-5-hydroxytryptamine', 'Hamilton Depression scale (HAMD', 'depressive symptoms', 'urinary specific metabolites']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0065591', 'cui_str': 'Malonic acid'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067783', 'cui_str': 'N-acetylserotonin'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",60.0,0.101856,"Compared with the control group, the EA group showed more significant improvements in depressive symptoms measured by HAMD at week 4 (16.89 ± 5.74 vs 25.58 ± 7.03, P < .001), week 8 (9.59 ± 5.13 vs 25.04 ± 7.49, P < .001) and week 12 (11.07 ± 6.85 vs 27.25 ± 7.14, P < .001).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Manqin', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Zaoyuan', 'Initials': 'Z', 'LastName': 'Kuang', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou.'}, {'ForeName': 'Shifen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Medicine,['10.1097/MD.0000000000022752']
1499,33120779,The efficacy of a phone assistance nursing program for functional outcomes in patients after shoulder instability surgery: A protocol for randomized controlled trial.,"OBJECTIVE


We conduct this research protocol for the assessment of the effect of phone-assisted care programs on functional outcomes in patients receiving shoulder instability surgery.
METHODS


This is a randomized controlled, single center trial which will be implemented from October 2020 to December 2021. This trial is conducted according to the SPIRIT Checklist of randomized researches. It was authorized via the Ethics Committee of the First People's Hospital of Xiangyang city affiliated to Hubei Medical College (XY234-026). Ninety participants who undergo shoulder instability surgery are analyzed. Patients are randomly divided into control group (standard management group, with 45 patients) and study group (the phone program group, with 45 patients). In control group, the exercises at home are not monitored. Whereas in study group, patients are asked about their at-home activities, and the extra coaching sessions are provided to patients on self-care, exercise guidance, and the importance of exercise at home, and then answers to their questions. The primary outcome is the range of motion of the shoulder joint, and the pain arcs are determined through the range of motion. The extra assessments include the shoulder functional outcome, pain, and the quality of life. All the analysis needed in this study is implemented with SPSS (IBM, Chicago, USA) for Windows Version 19.0.
RESULTS


The clinical outcome variables between groups are shown in Table.
CONCLUSION


This investigation can offer a reliable basis for the effectiveness of phone assistance nursing program in patients after shoulder instability surgery.
TRIAL REGISTRATION NUMBER


researchregistry6010.",2020,"OBJECTIVE


We conduct this research protocol for the assessment of the effect of phone-assisted care programs on functional outcomes in patients receiving shoulder instability surgery.
","['October 2020 to December 2021', 'patients after shoulder instability surgery', 'Ninety participants who undergo shoulder instability surgery are analyzed', ""First People's Hospital of Xiangyang city affiliated to Hubei Medical College (XY234-026"", 'patients receiving shoulder instability surgery']","['phone-assisted care programs', 'phone assistance nursing program']","['range of motion of the shoulder joint, and the pain arcs are determined through the range of motion', 'functional outcomes', 'shoulder functional outcome, pain, and the quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.0880653,"OBJECTIVE


We conduct this research protocol for the assessment of the effect of phone-assisted care programs on functional outcomes in patients receiving shoulder instability surgery.
","[{'ForeName': 'Yongling', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Operating Room.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Junchang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Gynaecology and Obstetrics, the First People's Hospital of Xiangyang City Affiliated to Hubei Medical College, Hubei, China.""}]",Medicine,['10.1097/MD.0000000000022756']
1500,33120788,Cone beam computed tomography imaging of sagittal positions of the mandibular prominence and maxillary central incisors in adult Chinese Han men as an aesthetic profile determinant.,"BACKGROUND


To analyze the sagittal positions of the mandibular prominence and maxillary central incisors in adult Chinese Han men to establish their aesthetic profile characteristics.
METHODS


Seventy-four Chinese Han men aged 18 to 40 years underwent cone beam computed tomography for detecting the distances between Glabella and Subnasale, Subnasale and Menthon of soft tissue, Condyle and Gonion, Pogonion and Pogonion's Anterior Limit Line, Facial Axis point of maxillary central incisor and the Goal Anterior Limit Line as well as the angle of the Occlusal Plane. Dolphin Imaging and Photoshop software packages were used to generate silhouette profiles. Thirteen orthodontists assessed the silhouette profiles and assigned visual analog scale scores. Scores >70 were assigned to the aesthetic (group 1), scores of 60to 70 to the general (group 2), scores of 50 to 60 to the acceptable (group 3), and scores of <50 to the unaesthetic profile (group 4).
RESULTS


A total of 15 men were assigned to group 1, 35 to group 2, 14 to group 3, and 10 to group 4. There were no significant differences in the variables examined between groups 1, 2, and 3, but comparing group 1 with group 4, Pogonion and Pogonion's Anterior Limit Line (1.16 ± 2.61 mm vs -1.44 ± 2.92 mm, P = .046) and Facial Axis-Goal Anterior Limit Line (-0.61 ± 2.54 mm vs 1.70 ± 2.62 mm, P = .038) there were significant differences.
CONCLUSION


Compared with the unaesthetic profile group, the sagittal positions of the maxillary central incisors were slightly posterior, and the chin was slightly anterior in adult Chinese Han men with an aesthetic profile.",2020,"There were no significant differences in the variables examined between groups 1, 2, and 3, but comparing group 1 with group 4, Pogonion and Pogonion's Anterior Limit Line (1.16 ± 2.61 mm vs -1.44 ± 2.92 mm, P = .046) and Facial Axis-Goal Anterior Limit Line (-0.61 ± 2.54 mm vs 1.70 ± 2.62 mm, P = .038) there were significant differences.
","['A total of 15 men', 'Seventy-four Chinese Han men aged 18 to 40 years underwent', 'adult Chinese Han men with an aesthetic profile', 'adult Chinese Han men']","['Dolphin Imaging and Photoshop software packages', ""cone beam computed tomography for detecting the distances between Glabella and Subnasale, Subnasale and Menthon of soft tissue, Condyle and Gonion, Pogonion and Pogonion's Anterior Limit Line, Facial Axis point of maxillary central incisor"", 'Cone beam computed tomography imaging of sagittal positions']","['silhouette profiles and assigned visual analog scale scores', 'Facial Axis-Goal Anterior Limit Line']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0641339', 'cui_str': 'hexaaquanickel(II) chlorate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0524414', 'cui_str': 'Structure of condyle'}, {'cui': 'C1185651', 'cui_str': 'Cephalometric gonion point'}, {'cui': 'C2334731', 'cui_str': 'Cephalometric pogonion point'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",15.0,0.051886,"There were no significant differences in the variables examined between groups 1, 2, and 3, but comparing group 1 with group 4, Pogonion and Pogonion's Anterior Limit Line (1.16 ± 2.61 mm vs -1.44 ± 2.92 mm, P = .046) and Facial Axis-Goal Anterior Limit Line (-0.61 ± 2.54 mm vs 1.70 ± 2.62 mm, P = .038) there were significant differences.
","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Miao', 'Affiliation': 'State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, The Fourth Military Medical University.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, The Fourth Military Medical University.'}, {'ForeName': 'Zhiyao', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Stomatology, Xi'an First Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zuolin', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Orthodontics, School of Stomatology, The Fourth Military Medical University.'}]",Medicine,['10.1097/MD.0000000000022778']
1501,33137547,Impact of a medical mobile phone app (QUiPP) for predicting preterm birth on the anxiety and decisional conflicts faced by women in threatened preterm labour.,"BACKGROUND


The QUiPP app is a free, validated mobile phone application (app) that supports clinical decision-making for women in threatened preterm labour by providing an individualised risk of delivery within clinically important time points. Alongside generating a percentage risk score, the QUiPP app also provides the risk score in an infographic donut chart, allowing the clinician to communicate with the woman in an easy to understand format. Informing women of their risk status using the QUIPP app may help to reduce anxiety in women and decrease decisional conflict.
METHOD


A subset of participants from the EQUIPTT study [REC Ref. 17/LO/1802] were asked to complete a questionnaire booklet which was used to evaluate decisional conflict and anxiety. Seven sites were randomised to the QUiPP app intervention (to use as a decision and communication tool) and six sites were randomised to the control (continued their normal practice). The first section of the questionnaire booklet was completed by the woman before her assessment, and the second section after. The pre and postassessment anxiety scores utilised the Visual Analogue Scale for Anxiety (Hornblow and Kidson, 1976). The Decisional Conflict Scale (O'Connor, 1995) measured decisional conflict post assessment. The data were then analysed to determine the impact of the QUiPP App on the anxiety and decisional conflicts faced by women in threatened preterm labour.
RESULTS


Questionnaires were completed by 221 women from 12 of the potential 13 sites. After exclusions 202 questionnaires were included in the analysis. There was a significant reduction in difference between anxiety scores before and after clinical assessment. While there were reductions in anxiety and decisional conflict for women who were aware of the QUiPP app use, this failed to reach statistical significance.
CONCLUSIONS


The QUiPP app has potential to reduce anxiety and decisional conflict in women who are aware that it is being used in their care. Additional work is required to ensure clinicians are aware of the QUiPP app and optimise using it as a communication tool when counselling women.",2020,The QUiPP app has potential to reduce anxiety and decisional conflict in women who are aware that it is being used in their care.,"['women in threatened preterm labour', '221 women from 12 of the potential 13 sites']","['QUiPP', 'medical mobile phone app (QUiPP', 'QUiPP app intervention']","['anxiety and decisional conflict', 'anxiety scores', ""Decisional Conflict Scale (O'Connor, 1995) measured decisional conflict post assessment"", 'decisional conflict and anxiety', 'pre and postassessment anxiety scores utilised the Visual Analogue Scale for Anxiety (Hornblow and Kidson, 1976']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",202.0,0.0402312,The QUiPP app has potential to reduce anxiety and decisional conflict in women who are aware that it is being used in their care.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Carlisle', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH. Electronic address: naomi.h.carlisle@kcl.ac.uk.""}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Watson', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kuhrt', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Tribe', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH.""}]",Midwifery,['10.1016/j.midw.2020.102864']
1502,33137579,"Supporting Play, Exploration, and Early Development Intervention (SPEEDI) for preterm infants: A feasibility randomised controlled trial in an Australian context.","BACKGROUND


An early intervention that enhances early development in infants born preterm, called 'Supporting Play, Exploration and Early Development Intervention' (SPEEDI) has been shown to be feasible in Virginia, United States, in a pilot study. Infants receive 10 therapy sessions until 3 months' corrected age (CA) (Phase 1[5 hospital sessions] and Phase 2[5 home-based sessions]) in addition to usual care.
AIMS


To determine the feasibility of SPEEDI for very preterm infants in an Australian context.
STUDY DESIGN


Prospective pilot feasibility randomised controlled trial.
SUBJECTS


Infants born <30 weeks' gestation (GA), recruited between 34 and 38 +6  weeks' postmenstrual age.
OUTCOME MEASURES


Primary outcome was feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity. Secondary outcome measures were developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4 months' CA.
RESULTS


Of 19 eligible infants, 17 consented, SPEEDI n = 8 and usual care n = 9 (mean GA = 26.7 weeks [SD 1.4], male n = 10). All participants completed the study, with 80% of SPEEDI therapy sessions completed (90% Phase 1; 72% Phase 2). On average, therapists and parents used 78% and 77% of SPEEDI strategies in each session respectively. Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
CONCLUSIONS


SPEEDI is a feasible intervention to deliver, and preliminary results suggest that SPEEDI may lead to improved motor and language outcomes at 4 months' CA, with results supporting future larger clinical trials.",2020,"Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
","['preterm infants', ""Infants born <30\xa0weeks' gestation (GA), recruited between 34 and 38 +6  weeks' postmenstrual age"", 'infants born preterm', 'very preterm infants in an Australian context', '19 eligible infants, 17 consented, SPEEDI n\xa0=\xa08 and usual care']",[],"['feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity', ""developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4\xa0months' CA"", 'BSID-III for gross motor, and expressive and receptive language subscales']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",19.0,0.112813,"Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
","[{'ForeName': 'Francyne', 'Initials': 'F', 'LastName': 'Finlayson', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia. Electronic address: fsamara@student.unimelb.edu.au.""}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Olsen', 'Affiliation': ""Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'University of Southern California, 1540 Alcazar St #155, Los Angeles, California 90033, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'IRCCS Fondazione Stella Maris, Viale del Tirreno, 331, 56128 Calambrone, Pisa, Italy.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Eeles', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Spittle', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}]",Early human development,['10.1016/j.earlhumdev.2020.105172']
1503,33137580,A breastfeeding support program changed breastfeeding patterns but did not affect the mothers' self-efficacy in breastfeeding at two months.,"BACKGROUND


Even though the biological norm in humans is frequent on demand breastfeeding, sparse feeding intervals have become the cultural norm in most Western countries due to a history of on schedule breastfeeding. This discrepancy between the biological basis and the culturally driven practice continues to interfere with women's ability to breastfeed.
AIM


Our aim was to describe breastfeeding patterns in 2-month-old infants before and after the implementation of a breastfeeding support program. A secondary aim was to investigate the relationship between breastfeeding patterns and the mother's self-efficacy in breastfeeding.
METHODS


The study had a baseline/intervention design and was part of a larger project aiming to revive the Ten Steps to Successful Breastfeeding program. The larger project included breastfeeding training for health care professionals and provision of breastfeeding information to parents, including information about on demand breastfeeding. Data were gathered via breastfeeding diaries (n = 79 mothers from each group) and the Breastfeeding Self-efficacy Scale-Short Form (n = 83 in the baseline group and n = 79 in the intervention group).
RESULTS


On demand breastfeeding patterns were more common in the intervention group (97.5%) than in the baseline group (74.7%) (p < 0.001), and breastfeeding sessions were more frequent in the intervention group (a median of 14 times per 24 h versus 11 times in the baseline group; p = 0.026). Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
CONCLUSIONS


Knowledge about infants' breastfeeding behavior can strengthen on demand breastfeeding. Exclusive breastfeeding is associated with higher self-efficacy.",2020,"Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
",['mothers with exclusive breastfeeding'],['breastfeeding training'],"['Self-efficacy', 'breastfeeding sessions', 'Breastfeeding Self-efficacy Scale-Short Form']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",,0.0233632,"Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Oras', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden. Electronic address: paola.oras@kbh.uu.se.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Ljungberg', 'Affiliation': 'Psychiatric Clinic, Nyköping Hospital, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hellström-Westas', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Eva-Lotta', 'Initials': 'EL', 'LastName': 'Funkquist', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Early human development,['10.1016/j.earlhumdev.2020.105242']
1504,33137581,Does focus of attention alter craniocervical flexion test motor learning? A randomized controlled trial.,"OBJECTIVE


To evaluate the effects of three different foci of attention (internal, external and mixed) on motor learning using craniocervical flexion test in inexperienced participants.
METHODS


Ninety healthy young adults, with no experience in the task, practiced the craniocervical flexion test under three different focus of attention: a) Mixed Focus (internal plus external), b) Internal Focus, and c) External Focus. We assessed immediate, post-training, and retention (one week after the last training session) aspects of motor learning by quantifying (i) the activity of the superficial cervical flexors muscles, (ii) craniocervical range of motion, and (iii) the performance on the craniocervical flexion test.
RESULTS


None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression. At immediate assessment, mixed focus had greater craniocervical flexion performance than external (MD 0.9, 95%CI 0.2 to 1.5), and internal foci (MD 1.4, 95%CI 0.8 to 2.1). At post-training, mixed focus led to better craniocervical performance compared to external (MD 1.6, 95%CI 0.8 to 2.4) and internal foci (MD 2.7, 95%CI 1.9 to 3.5). External focus had better scores on the craniocervical flexion test performance than internal focus (MD 1.1, 95%CI 0.3 to 1.9). Results remained similar at retention, with mixed focus being superior to internal (MD 2.3, 95%CI 1.7 to 3) and external foci (MD 1.5, 95%CI 0.9 to 2.1) on craniocervical flexion test performance. Similarly, the performance on the craniocervical flexion test performance remained similar at retention between external and internal foci (MD 0.9, 95%CI 0.2 to 1.5).
CONCLUSION


In inexperienced asymptomatic participants, different foci of attention were not able to change cervical muscle activity and craniocervical range of motion during the craniocervical flexion test. Mixed focus was better than external and internal focus on the craniocervical flexion test. These findings were retained after one week.",2020,"None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression.","['Ninety healthy young adults, with no experience in the task, practiced the craniocervical flexion test under three different focus of attention: a', 'inexperienced participants']","['motor learning by quantifying (i) the activity of the superficial cervical flexors muscles, (ii) craniocervical range of motion, and (iii) the performance on the craniocervical flexion test', 'Mixed Focus (internal plus external), b) Internal Focus, and c', 'foci of attention (internal, external and mixed']","['craniocervical flexion performance', 'superficial neck flexors activity and craniocervical range of motion progression', 'craniocervical performance', 'craniocervical flexion test performance']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}]",90.0,0.05819,"None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression.","[{'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Scholl Schell', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. Electronic address: mauriciosc@ufcpsa.edu.br.'}, {'ForeName': 'Francisco Xavier', 'Initials': 'FX', 'LastName': 'de Araujo', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Physical Therapy Department, Centro Universitário Ritter dos Reis - UniRitter, Porto Alegre, Brazil.'}, {'ForeName': 'Rosicler', 'Initials': 'R', 'LastName': 'da Rosa Almeida', 'Affiliation': 'Physical Therapy Department, Undergraduate Program, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Brazil.'}, {'ForeName': 'Ian Sulzbacher', 'Initials': 'IS', 'LastName': 'Peroni', 'Affiliation': 'Physical Therapy Department, Undergraduate Program, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Brazil.'}, {'ForeName': 'Carolina Gomes', 'Initials': 'CG', 'LastName': 'Rosa', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Physical Therapy Department, Post Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. Electronic address: marcelofs@ufcspa.edu.br.'}]",Human movement science,['10.1016/j.humov.2020.102709']
1505,33139133,"Effect of a vaccine information statement (VIS) on immunization status and parental knowledge, attitudes, and beliefs regarding infant immunization in Japan.","BACKGROUND


Because of the overabundance of vaccination information on the internet, in the media, and on social media, providing clear and correct information on immunization is critical for parental decision-making. In 2018, the Japan Pediatric Society created and distributed a Vaccine Information Statement (VIS) to provide appropriate immunization information to caregivers. The objectives of the present study were to evaluate the effect of the VIS on immunization rates, adherence to schedule, and parental understanding of immunization in Japan.
METHODS


This cross-sectional study was conducted at 18 centers in 2 prefectures in Japan. Caregivers were assigned to an intervention group, which received the VIS and a questionnaire when their child reached the age of 1 month, and a control group, which received only the questionnaire. Using the self-reported questionnaires, we evaluated vaccination rates and schedule adherence at age 2 months, and parental knowledge, attitudes, and beliefs regarding immunization. Three months later, the questionnaires were returned, and the findings were compared between the 2 groups.
RESULTS


We contacted 422 and 428 persons in the intervention and control groups, respectively, and 111/422 (26.3%) and 119/428 (27.8%) returned the surveys. Vaccination rates and adherence rates for the first dose of 4 recommended vaccines did not differ significantly (P > 0.25); however, there were some positive effects on items related to vaccine knowledge (P = 0.03), perceived benefits (P = 0.02), perceived barriers (P < 0.001), and perceived behavioral control (P = 0.01).
CONCLUSION


The VIS improved parent comprehension of infant immunization. Future studies should examine if the effects of such an intervention persist and affect vaccine uptake throughout childhood.",2020,"Vaccination rates and adherence rates for the first dose of 4 recommended vaccines did not differ significantly (P > 0.25); however, there were some positive effects on items related to vaccine knowledge (P = 0.03), perceived benefits (P = 0.02), perceived barriers (P < 0.001), and perceived behavioral control (P = 0.01).
","['Japan', '422 and 428 persons in the intervention and control groups, respectively, and 111/422 (26.3%) and 119/428 (27.8%) returned the surveys', '18 centers in 2 prefectures in Japan']",['vaccine information statement (VIS'],"['immunization status and parental knowledge, attitudes, and beliefs regarding infant immunization', 'Vaccination rates and adherence rates', 'vaccination rates and schedule adherence at age 2\xa0months, and parental knowledge, attitudes, and beliefs regarding immunization', 'behavioral control']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0552506', 'cui_str': 'Immunization status'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0376148,"Vaccination rates and adherence rates for the first dose of 4 recommended vaccines did not differ significantly (P > 0.25); however, there were some positive effects on items related to vaccine knowledge (P = 0.03), perceived benefits (P = 0.02), perceived barriers (P < 0.001), and perceived behavioral control (P = 0.01).
","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Saitoh', 'Affiliation': 'Department of Nursing, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Electronic address: ayasaitoh8@clg.niigata-u.ac.jp.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Saitoh', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Katsuta', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Mahito', 'Initials': 'M', 'LastName': 'Mine', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Mine Pediatric Clinic, Saitama, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kamiya', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Miyairi', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Division of Infectious Diseases, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Naruhiko', 'Initials': 'N', 'LastName': 'Ishiwada', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Infectious Diseases, Medical Mycology Research Center, Chiba University, Chiba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oshiro', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Neonatology, Japanese Red Cross Nagoya Daiichi Hospital, Aichi, Japan.'}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Kira', 'Affiliation': ""The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatric Neurology, Fukuoka Children's Hospital, Fukuoka, Japan.""}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Shimizu', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Suga', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Infectious Disease Center and Department of Clinical Research, National Hospital Organization Mie Hospital, Mie, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tsugawa', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Fujioka', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Fujioka Pediatrics, Osaka, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Miyazaki', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Fukuoka Welfare Center for the Disabled, Fukuoka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Morioka', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Korematsu', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Tanaka-Taya', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Tokyo, Japan.'}, {'ForeName': 'Tetsushi', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Iwata', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Infectious Diseases, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Kusuhara', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Azuma', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Asahikawa Medical University, Hokkaido, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Moriuchi', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Nagasaki University, Nagasaki, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Okabe', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Kawasaki City Institute for Public Health, Kanagawa, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Hosoya', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsumi', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Department of Pediatrics, Sapporo Medical University School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'The Committee on Immunization and Infectious Diseases, Japan Pediatric Society, Japan; Division of Basic Nursing, Fukuoka Nursing College, Fukuoka, Japan.'}]",Vaccine,['10.1016/j.vaccine.2020.10.049']
1506,33140428,Healing of donor sites of connective tissue grafts harvested by the single incision technique. A randomized clinical trial evaluating the use of collagen hemostatic sponge with or without sutures.,"BACKGROUND


The aim of this study was to evaluate the effect of suturing on the early wound healing of donor sites of subepithelial connective tissue grafts (SCTG), harvested by the single incision technique (SIT), following the application of a collagen sponge.
METHODS


Thirty-six patients were randomized to receive a collagen sponge with or without sutures in the palatal donor sites following connective tissue grafting via the SIT. Outcome variables were early healing index (EHI) at 7, 14, and 30 days, self-reported pain using a visual analogue scale (VAS) recorded on the 0 to 100 scale at 7 and 14 days, and immediate and delayed bleeding.
RESULTS


No significant differences were found between groups at baseline. EHI index showed no differences between groups in all-time intervals. Eight subjects from suture group (SG) and 10 from no suture group (nSG) showed complete wound closure at day 14 (P >0.05) and at 30 days, complete closure was observed in 35 out of 36 patients. Four subjects from the SG and three from the nSG had immediate bleeding (P >0.05), while delayed bleeding was observed in two subjects from the SG and three from the nSG during the first week of healing (P >0.05). No differences were found in VAS scale between groups (SG, 36.2 ± 24.8; nSG, 21.5 ± 24.2, P >0.05).
CONCLUSION


It can be concluded that when a collagen sponge is placed in palatal donor areas of SCTG harvest by means of the SIT (incision length of ≈15 mm), sutured and non-sutured sites display similar early wound healing outcomes and patient-reported outcomes.",2020,"Four subjects from the SG and three from the nSG had immediate bleeding (p > 0.05), while delayed bleeding was observed in two subjects from the SG and three from the nSG during the first week of healing (P > 0.05).",[' : Thirty-six patients'],"['collagen hemostatic sponge with or without sutures', 'subepithelial connective tissue grafts (SCTG), harvested by the single incision technique (SIT', 'no suture group (nSG', 'collagen sponge with or without sutures in the palatal donor sites following connective tissue grafting via the SIT']","['VAS scale', 'Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) recorded on the 0-100 scale at 7 and 14 days, and immediate and delayed bleeding', 'EHI index', 'immediate bleeding', 'complete wound closure', 'delayed bleeding']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]",36.0,0.021246,"Four subjects from the SG and three from the nSG had immediate bleeding (p > 0.05), while delayed bleeding was observed in two subjects from the SG and three from the nSG during the first week of healing (P > 0.05).","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Schinini', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Sales', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Mariel V', 'Initials': 'MV', 'LastName': 'Gómez', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Hugo J', 'Initials': 'HJ', 'LastName': 'Romanelli', 'Affiliation': 'Department of Postgraduate Periodontics, Maimónides University, Buenos Aires, Argentina.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Chambrone', 'Affiliation': 'School of Dentistry, Ibirapuera University, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0645']
1507,33140841,Experiences of induction of labor with a catheter - A prospective randomized controlled trial comparing the outpatient and inpatient setting.,"INTRODUCTION


Approximately every fourth labor is induced. In Finland, when labor is induced, it is commonly carried out with a catheter in the inpatient (IP) setting. However, in uncomplicated, full-term pregnancies, induction of labor (IOL) in the outpatient (OP) setting is also possible. Nevertheless, there is only a limited amount of information about the experiences of IOL in OP setting. Our study compared the experiences of catheter IOL in OP and IP settings.
MATERIAL AND METHODS


We performed a prospective randomized study, including 113 women with uncomplicated full-term pregnancies with planned IOL. After catheter insertion, women were randomized into OP or IP settings: after dropouts, there were 53 women in the OP group and 54 in the IP. The experiences of IOL were evaluated with three sets of visual analog scale (VAS) questionnaires: the general experience questionnaire (eight questions), the concurrent induction experience questionnaire (1, 5, 9, 13 hours; nine questions) and the postpartum experience questionnaire (14 questions).
RESULTS


Both groups had low VAS scores, indicating good experiences of IOL. Women in the OP group were less satisfied (mean VAS difference Δ = 7.8, P = .015) and more anxious (Δ = 4.8, P = .008) than were women in the IP group. In the course of the IOL, all women became less satisfied (Δ = 8.4, P = .001), had more contraction pain (Δ = 8.9, P = .020) and had a higher frequency of contractions (Δ = 9.9, P = .004) but they were more relaxed and experienced less fear (Δ = 6.9, P = .036, Δ = 5.3, P = .001, respectively). There was no interaction between group and time. According to the postpartum experience questionnaire, both groups had a similar good general experience of IOL (P = .736) but the OP group had more fear (Δ = 9.5, P = .009) and was more anxious (Δ = 9.0, P = .007). Most of the women would choose catheter IOL in a subsequent pregnancy (OP 82.6%, IP 87.0%).
CONCLUSIONS


The women in the OP setting were less satisfied and more anxious than were the women in the IP setting. However, the differences were marginal and the general experience after IOL was good. IOL in an OP setting is thus a viable option in low-risk full-term pregnancies. Therefore, when using catheter IOL, both setting options should be available.",2020,"Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group.",['113 women with uncomplicated full-term pregnancies with planned IOL'],[],"['frequency of contractions', 'visual analogue scale (VAS) questionnaires', 'low VAS scores', 'anxious', 'contraction pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]",[],"[{'cui': 'C0233126', 'cui_str': 'Frequency of uterine contraction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",113.0,0.0284907,"Women in the OP group were less satisfied (mean VAS difference Δ=7.8, P=0.015) and more anxious (Δ=4.8, P=0.008) than women in the IP group.","[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Haavisto', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Polo-Kantola', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Anttila', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Kolari', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Ojala', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Rinne', 'Affiliation': 'Department of Obstetrics and Gynecology, Turku University Hospital and University of Turku, Turku, Finland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14037']
1508,33141094,Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Internal Pilot of a Randomized Controlled Trial.,"BACKGROUND


To improve health outcomes in patients with heart failure, guideline-directed medical therapy (GDMT) should be optimized to target doses. However, GDMT remains underutilized, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring could provide reliable and real-time physiological data for clinical decision support to facilitate remote GDMT titration.
OBJECTIVE


This paper aims to present findings from an internal pilot study regarding the effectiveness of remote titration facilitated by telemonitoring.
METHODS


A 2-arm randomized controlled pilot trial comparing remote titration versus standard care in a heart function clinic was conducted. Patients were randomized to undergo remote medication titration facilitated by data from a smartphone-based telemonitoring system or standard titration performed during clinic visits.
RESULTS


A total of 42 patients with new-onset (10/42, 24%) and existing (32/42, 76%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019. Within 6 months of enrollment, 86% (18/21) of patients in the intervention group achieved optimal doses versus 48% (10/21) of patients in the control group. The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group. The number of in-person visits in the intervention group was 54.5% lower than in the control group.
CONCLUSIONS


The results of this pilot study suggest that remote titration facilitated by telemonitoring has the potential to increase the proportion of patients who achieve optimal GDMT doses, decrease time to dose optimization, and reduce the number of clinic visits. Remote titration may facilitate optimal and efficient titration of patients with heart failure while reducing the burden for patients to attend in-person clinic visits.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/preprints.19705.",2020,The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group.,"['Patients With Heart Failure', 'patients with heart failure, guideline-directed medical therapy (GDMT', 'patients with heart failure', '42 patients with new-onset (10/42, 24%) and existing (32/42, 76%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019']","['remote titration versus standard care', 'smartphone-based telemonitoring system or standard titration performed during clinic visits', 'Remote Titration Combined With Telemonitoring']","['median time to dose optimization', 'number of in-person visits', 'number of clinic visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",42.0,0.0994951,The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group.,"[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Artanian', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ross', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Valeria E', 'Initials': 'VE', 'LastName': 'Rac', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'Peter Munk Cardiac Centre, Division of Cardiology, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Darshan H', 'Initials': 'DH', 'LastName': 'Brahmbhatt', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seto', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}]",JMIR cardio,['10.2196/21962']
1509,33141096,Computer-Tailored Decision Support Tool for Lung Cancer Screening: Community-Based Pilot Randomized Controlled Trial.,"BACKGROUND


Lung cancer screening is a US Preventive Services Task Force Grade B recommendation that has been shown to decrease lung cancer-related mortality by approximately 20%. However, making the decision to screen, or not, for lung cancer is a complex decision because there are potential risks (eg, false positive results, overdiagnosis). Shared decision making was incorporated into the lung cancer screening guideline and, for the first time, is a requirement for reimbursement of a cancer screening test from Medicare. Awareness of lung cancer screening remains low in both the general and screening-eligible populations. When a screening-eligible person visits their clinician never having heard about lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Methods to effectively prepare patients for these clinical encounters and support both patients and clinicians to engage in these important discussions are needed.
OBJECTIVE


The aim of the study was to estimate the effects of a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards that will prepare individuals and support shared decision making in lung cancer screening decisions.
METHODS


A pilot randomized controlled trial with a community-based sample of 60 screening-eligible participants who have never been screened for lung cancer was conducted. Approximately half of the participants (n=31) were randomized to view LungTalk-a web-based tailored computer program-while the other half (n=29) viewed generic information about lung cancer screening from the American Cancer Society. The outcomes that were compared included lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), and perception of being prepared to engage in a discussion about lung cancer screening with their clinician.
RESULTS


Knowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change). Perceived self-efficacy and perceived benefits improved in the theoretically expected directions.
CONCLUSIONS


LungTalk goes beyond other decision tools by addressing lung health broadly, in the context of performing a low-dose computed tomography of the chest that has the potential to uncover other conditions of concern beyond lung cancer, to more comprehensively educate the individual, and extends the work of nontailored decision aids in the field by introducing tailoring algorithms and message framing based upon smoking status in order to determine what components of the intervention drive behavior change when an individual is informed and makes the decision whether to be screened or not to be screened for lung cancer.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.8694.",2020,"RESULTS


Knowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change).","['community-based sample of 60 screening-eligible participants who have never been screened for lung cancer was conducted', 'Lung Cancer Screening']","['view LungTalk-a web-based tailored computer program-while the other half (n=29) viewed generic information about lung cancer screening from the American Cancer Society', 'Computer-Tailored Decision Support Tool']","['Perceived self-efficacy', 'Knowledge scores', 'lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), and perception of being prepared to engage in a discussion about lung cancer screening with their clinician']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",60.0,0.0523865,"RESULTS


Knowledge scores increased significantly for both groups with greater improvement noted in the group receiving LungTalk (2.33 vs 1.14 mean change).","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Carter-Harris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Robert Skipworth', 'Initials': 'RS', 'LastName': 'Comer', 'Affiliation': 'Indiana University School of Informatics and Computing, Indianapolis, IN, United States.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Slaven Ii', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Vode', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States.'}, {'ForeName': 'Nasser H', 'Initials': 'NH', 'LastName': 'Hanna', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'DuyKhanh Pham', 'Initials': 'DP', 'LastName': 'Ceppa', 'Affiliation': 'School of Medicine, Indiana University, Indianapolis, IN, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Rawl', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, IN, United States.'}]",Journal of medical Internet research,['10.2196/17050']
1510,33141099,Effect of a Text Messaging-Based Educational Intervention on Cesarean Section Rates Among Pregnant Women in China: Quasirandomized Controlled Trial.,"BACKGROUND


Consensus exists that appropriate regional cesarean rates should not exceed 15% of births, but China's cesarean rate exceeds 50% in some areas, prompting numerous calls for its reduction. At present, China's 2016 two-child policy has heightened the implications of national cesarean section trends.
OBJECTIVE


This study leveraged pervasive cellular phone access amongst Chinese citizens to test the effect of a low-cost and scalable prenatal advice program on cesarean section rates.
METHODS


Participants were pregnant women presenting for antenatal care at a clinic in Xi'an, China. Assignment was quasirandomized and utilized factorial assignment based on the expecting mother's birthday. Participants were assigned to one of the following four groups, with each receiving a different set of messages: (1) a comparison group that received only a few ""basic"" messages, (2) a group receiving messages primarily regarding care seeking, (3) a group receiving messages primarily regarding good home prenatal practices, and (4) a group receiving text messages of all groups. Messages were delivered throughout pregnancy and were tailored to each woman's gestational week. The main outcome was the rates of cesarean delivery reported in the intervention arms. Data analysts were blinded to treatment assignment.
RESULTS


In total, 2115 women completed the trial and corresponding follow-up surveys. In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact. Adjusting for potentially confounding covariates showed that the group with all texts sent together was associated with an odds ratio of 0.67 (P=.01). Notably, previous cesarean section evoked an odds ratio of 11.78 (P<.001), highlighting that having a cesarean section predicts future cesarean section in a subsequent pregnancy.
CONCLUSIONS


Sending pregnant women in rural China short informational messages with integrated advice regarding both care-seeking and good home prenatal practices appears to reduce women's likelihood of undergoing cesarean section. Reducing clear medical indications for cesarean section seems to be the strongest potential pathway of the effect. Cesarean section based on only maternal request did not seem to occur regularly in our study population. Preventing unnecessary cesarean section at present may have a long-term impact on future cesarean section rates.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02037087; https://clinicaltrials.gov/ct2/show/NCT02037087.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1136/bmjopen-2015-011016.",2020,"In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact.","['Pregnant Women in China', ""Participants were pregnant women presenting for antenatal care at a clinic in Xi'an, China"", '2115 women completed the trial and corresponding follow-up surveys', 'Sending pregnant women in rural']","['Text Messaging-Based Educational Intervention', 'low-cost and scalable prenatal advice program', 'China short informational messages with integrated advice regarding both care-seeking and good home prenatal practices', 'comparison group that received only a few ""basic"" messages, (2) a group receiving messages primarily regarding care seeking, (3) a group receiving messages primarily regarding good home prenatal practices, and (4) a group receiving text messages of all groups']","['rates of cesarean delivery', 'Cesarean Section Rates', 'cesarean section rates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",2115.0,0.0904687,"In the unadjusted analysis, the group receiving all texts was associated with an odds ratio of 0.77 (P=.06), though neither the care seeking nor good home prenatal practice set yielded a relevant impact.","[{'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Heitner', 'Affiliation': 'Aceso Global, Washington, DC, United States.'}, {'ForeName': 'Changzheng', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""The Children's Hospital and School of Public Health, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': 'School of Risk & Actuarial Studies and Centre of Excellence in Population Ageing Research (CEPAR), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, China.""}, {'ForeName': 'Zhongliang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""School of Public Policy and Administration, Xi'an Jiaotong University, Xi'an, China.""}]",JMIR mHealth and uHealth,['10.2196/19953']
1511,33118688,Building clinical risk score systems for predicting the all-cause and expanded cardiovascular-specific mortality of patients with type 2 diabetes.,"AIM


To develop and validate risk score systems by examining the effects of glycaemic and blood pressure variabilities on the all-cause and expanded cardiovascular-specific mortality of people with type 2 diabetes.
MATERIALS AND METHODS


This retrospective cohort study consisted of 9692 patients aged 30-85 years, diagnosed with type 2 diabetes and enrolled in a managed care programme of a medical centre from 2002 to 2016. All the patients were randomly allocated into two groups, namely, training and validation sets (2:1 ratio), and followed up until death or August 2019. Cox's proportional hazard regression was performed to develop all-cause and expanded cardiovascular-specific mortality prediction models. The performance of the prediction model was assessed by using the area under the receiver operating characteristic curve (AUROC).
RESULTS


Overall, 2036 deaths were identified after a mean of 8.6 years of follow-up. The AUROC-measured prediction accuracies of 3-, 5-, 10- and 15-year all-cause mortalities based on a model containing the identified traditional risk factors, biomarkers and variabilities in fasting plasma glucose, HbA1c and blood pressure in the validation set were 0.79 (0.76-0.83), 0.78 (0.76-0.81), 0.80 (0.78-0.82) and 0.80 (0.78-0.82), respectively. The corresponding values of the expanded cardiovascular-specific mortalities were 0.85 (0.80-0.90), 0.83 (0.79-0.86), 0.80 (0.77-0.83) and 0.79 (0.77-0.82), respectively.
CONCLUSIONS


Our prediction models considering glycaemic and blood pressure variabilities had good prediction accuracy for the expanded cardiovascular-specific and all-cause mortalities of patients with type 2 diabetes.",2020,Our prediction models considering glycemic and blood pressure variabilities had good prediction accuracy for the expanded cardiovascular-specific and all-cause mortalities of patients with type 2 diabetes.,"['patients with type 2 diabetes', 'persons with type 2 diabetes', '9,692 patients aged 30-85\u2009years, diagnosed with type 2 diabetes, and enrolled in a managed care program of a medical center from 2002 to 2016']",[],"['fasting plasma glucose, HbA1c, and blood pressure', 'corresponding values of the expanded cardiovascular-specific mortalities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024679', 'cui_str': 'Managed Health Care Insurance Plans'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]",[],"[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",9692.0,0.0171368,Our prediction models considering glycemic and blood pressure variabilities had good prediction accuracy for the expanded cardiovascular-specific and all-cause mortalities of patients with type 2 diabetes.,"[{'ForeName': 'Chiu-Shong', 'Initials': 'CS', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chia-Ing', 'Initials': 'CI', 'LastName': 'Li', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Mu-Cyun', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Sing-Yu', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'Department of Public Health, College of Public Health, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Tsai-Chung', 'Initials': 'TC', 'LastName': 'Li', 'Affiliation': 'Department of Public Health, College of Public Health, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Cheng-Chieh', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14240']
1512,33119156,Randomised clinical trial: combined impact and resistance training in adults with stable Crohn's disease.,"BACKGROUND


Crohn's disease (CD) is a predisposing factor for bone loss and muscle dysfunction, which could lead to osteoporotic fractures and physical disability, respectively.
AIM


To assess the effect of 6 months of combined impact and resistance training on bone mineral density (BMD) and muscle function in adults with CD.
METHODS


In this randomised controlled trial, 47 adults with stable CD were assigned to exercise (n = 23) or control (n = 24) groups and followed up for 6 months. The exercise group received usual care plus a 6-month combined impact and resistance training programme, involving three, 60-minute sessions per week and a gradual tapering of supervision to self-management. The control group received usual care alone. The primary outcomes were BMD (via dual energy X-ray absorptiometry) and muscle function (measures of upper and lower limb strength and endurance) at 6 months.
RESULTS


At 6 months, BMD values were superior in the exercise group with statistical significance at lumbar spine (adjusted mean difference 0.036 g/cm 2 , 95% CI 0.024-0.048; P < 0.001), but not at femoral neck (0.018 g/cm 2 , 0.001-0.035; P = 0.059) or greater trochanter (0.013 g/cm 2 , -0.019 to 0.045; P = 0.415) after correcting for multiple outcomes. The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005). Three exercise-related adverse events were recorded: two instances of light-headedness and one of nausea.
CONCLUSIONS


The intervention improved BMD and muscle function in adults with CD and appears as a suitable model of exercise for reducing future risk of osteoporotic fractures and disability.
TRIAL REGISTRATION


ISRCTN11470370.",2020,"The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005).","[""adults with stable Crohn's disease"", 'adults with CD', ""Crohn's disease (CD"", '47 adults with stable CD']","['usual care plus a 6-month combined impact and resistance training programme', 'usual care alone', 'resistance training']","['femoral neck', 'BMD values', 'BMD (via dual energy X-ray absorptiometry) and muscle function (measures of upper and lower limb strength and endurance', 'bone mineral density (BMD) and muscle function', 'BMD and muscle function', 'lower fatigue severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",47.0,0.0780562,"The exercise group also had superior values for all muscle function outcomes (P < 0.001; unadjusted mean differences ranging 22.6‒48.2%), and lower fatigue severity (P = 0.005).","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'R Ally', 'Initials': 'RA', 'LastName': 'Speight', 'Affiliation': 'Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Thompson', 'Affiliation': 'Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Garry A', 'Initials': 'GA', 'LastName': 'Tew', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16002']
1513,33113452,Using Machine Learning to Predict Suicide Attempts in Military Personnel.,"Identifying predictors of suicide attempts is critical in intervention and prevention efforts, yet finding predictors has proven difficult due to the low base rate and underpowered statistical approaches. The objective of the current study was to use machine learning to examine predictors of suicidal behaviors among high-risk suicidal Soldiers who received outpatient mental health services in a randomized controlled trial of Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) compared to treatment as usual (TAU). Self-report measures of clinical and demographic variables, administered prior to the start of outpatient treatment to 152 participants with recent suicidal thoughts and/or behaviors were analyzed using machine learning software to identify the best combination of variables for predicting suicide attempts during or after treatment. Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period. This combination has higher sensitivity than many models that have previously been used to predict suicidal behavior. Overall, this study provides a combination of variables that can be assessed clinical to help identify high-risk suicidal individuals.",2020,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","['high-risk suicidal Soldiers who received outpatient mental health services', '152 participants with recent suicidal thoughts and/or behaviors', 'Military Personnel']","['Machine Learning', 'machine learning', 'Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT']",['suicidal behaviors'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",152.0,0.0395007,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rozek', 'Affiliation': 'UCF RESTORES and Department of Psychology, University of Central Florida. Electronic address: david.rozek@ucf.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Andres', 'Affiliation': 'Boston College, Boston, MA.'}, {'ForeName': 'Noelle B', 'Initials': 'NB', 'LastName': 'Smith', 'Affiliation': 'VA Northeast Program Evaluation Center, West Haven, CT, USA; Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Feea R', 'Initials': 'FR', 'LastName': 'Leifker', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Arne', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Jennings', 'Affiliation': 'Varen Technologies.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Dartnell', 'Affiliation': 'MondoBrain.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'The Ohio State University Wexner Medical Center.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'University of Memphis, Memphis, TN, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113515']
1514,33113486,Integrating yoga with psychological group-treatment for mixed depression and anxiety in primary healthcare: An explorative pilot study.,"BACKGROUND AND PURPOSE


Yoga has shown promise as a treatment for depression and anxiety. The present pilot study investigated the feasibility of an eight-week grouptreatment integrating emotion-focused psychoeducation, compassion-focused therapy, and Virya yoga for depression and anxiety in primary healthcare.
MATERIALS AND METHODS


Patients seeking treatment for depression and anxiety in a primary healthcare centre completed either an integrative group-treatment (N = 14) or treatment as usual (TAU, N = 17). Outcome measures were analysed pre- and posttreatment. Correlations in the intervention group were investigated between treatment outcomes and amount of yoga practice between sessions.
RESULTS


Large within-group effect sizes on all outcome measures were found at posttreatment. Symptom reduction did not differ between groups (p = 0.155). Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
CONCLUSION


Integrating yoga with a psychological group-treatment is a somewhat feasible approach to treatment for depression and anxiety in primary healthcare.",2020,"Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
","['Patients seeking treatment for depression and anxiety in a primary healthcare centre completed either an', 'primary healthcare']","['integrative group-treatment (N\xa0=\xa014) or treatment as usual (TAU', 'eight-week grouptreatment integrating emotion-focused psychoeducation, compassion-focused therapy, and Virya yoga', 'Integrating yoga with psychological group-treatment']","['alexithymia', 'Symptom reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0320634,"Improvement in alexithymia correlated significantly (p < 0.05) with amount of yoga practice between sessions.
","[{'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: gustav@psykologiochutveckling.se.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzén', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: lisa.franzen@regionvarmland.se.'}, {'ForeName': 'Markus B T', 'Initials': 'MBT', 'LastName': 'Nyström', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: Markus.nystrom@umu.se.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Umeå University, 901 87, Umeå, Sweden. Electronic address: Paul.davis@umu.se.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101250']
1515,33124506,Intensified Oral Hygiene Care in Stroke-Associated Pneumonia: A Pilot Single-Blind Randomized Controlled Trial.,"In this pilot, single-blind, randomized controlled trial, we investigated the effects of intensified oral hygiene care (IOHC) on reducing stroke-associated pneumonia (SAP) incidence. Patients admitted within 24 hours of stroke onset were recruited and randomized to receive IOHC or routine oral hygiene care. The occurrence of SAP was checked and oral swabs were obtained during the 7-day follow-up. The SAP incidence was lower, though not significantly, in the IOHC group than in the control group. IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores. Furthermore, IOHC significantly decreased the prevalence of oral suspected SAP pathogens. These results suggest that IOHC can decrease the incidence of SAP in the most vulnerable patient groups and lower the prevalence of suspected oral SAP pathogens.",2020,"IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores.","['Stroke-Associated Pneumonia', 'Patients admitted within 24\u2009hours of stroke onset']","['IOHC or routine oral hygiene care', 'intensified oral hygiene care (IOHC', 'IOHC', 'Intensified Oral Hygiene Care']","['occurrence of SAP', 'SAP incidence', 'stroke-associated pneumonia (SAP) incidence', 'Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores', 'prevalence of oral suspected SAP pathogens', 'incidence of SAP']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3536594', 'cui_str': 'Suspected cerebrovascular accident'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}]",,0.047624,"IOHC successfully decreased SAP incidence among patients who were male, had higher National Institutes of Health Stroke Scale and Debris Index scores, and lower Glasgow Coma Scale and Gugging Swallowing Screen scores.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yuan', 'Affiliation': 'Department of Geriatric Dentistry, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatric Dentistry, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of VIP Service, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatric Dentistry, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.'}]","Inquiry : a journal of medical care organization, provision and financing",['10.1177/0046958020968777']
1516,33124762,The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma.,"RATIONALE


Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once-daily ELLIPTA dry-powder inhaler (DPI) correctly, and who found it easy to use.
METHODS


This was a multicenter, single-arm, stratified, open-label, placebo study (NCT03478657). Children aged 5-7 and 8-11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28 ± 2 days. On returning to the clinic, children were randomized to an age-appropriate, ease-of-use questionnaire that had been developed and validated previously, and which rated the inhaler as ""easy"" or ""hard"" to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease-of use were assessed in each age group (co-primary endpoints) and overall (secondary endpoints).
RESULTS


Of 222 enrolled children, 221 completed the study. Among children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared with 93% (n = 124/133) aged 8-11 years. Of these children, 98% (5-7 years: n = 79/81; 8-11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
CONCLUSION


ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training.",2020,"Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
","['Of 222', 'children with asthma', 'children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared to 93% (n = 124/133) aged 8-11 years', 'Children aged 5-7 and 8-11 years', 'enrolled children, 221 completed the study']","['ELLIPTA DPI', 'placebo ELLIPTA DPI']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],222.0,0.0380348,"Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use.
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Halverson', 'Affiliation': 'Allergy and Asthma Specialists, P.A., Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Liem', 'Affiliation': 'Joel Liem Medicine Professional Corporation, Windsor, Ontario, Canada.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Heyes', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Preece', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bareille', 'Affiliation': 'GlaxoSmithKline plc, Stevenage, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park, UK.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'GlaxoSmithKline plc, North Carolina, USA.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Stanford', 'Affiliation': 'GlaxoSmithKline plc, North Carolina, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Lenney', 'Affiliation': 'GlaxoSmithKline plc, London, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collison', 'Affiliation': 'GlaxoSmithKline plc, North Carolina, USA.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'GlaxoSmithKline plc, London, UK.'}]",Pediatric pulmonology,['10.1002/ppul.25149']
1517,33119423,Lack of residual morning effects of lemborexant treatment for insomnia: summary of findings across 9 clinical trials.,"OBJECTIVES


Residual next-day effects of sleep-promoting drugs are common and an important safety issue. Lemborexant is a dual orexin receptor antagonist approved in the United States and Japan for treatment of insomnia in adults. We evaluated the potential of lemborexant for residual morning and next-day effects, including somnolence, based on lemborexant clinical study findings.
METHODS


This paper reports findings from 9 lemborexant clinical studies that incorporated next-day assessments of residual drug effects, based on published findings and data on file. Results are reported for healthy subjects or subjects with insomnia disorder treated with lemborexant 5 mg/day or 10 mg/day, placebo, or active comparator before bedtime. Outcomes assessed included next-morning postural stability (body sway measured by ataxiameter), cognitive performance (Cognitive Performance Assessment Battery), impact on driving (standard deviation of lateral position during highway driving test), subjective sleepiness (sleep diary entries), and adverse events of somnolence.
RESULTS


Change from baseline in postural stability the morning after lemborexant administration did not differ from placebo. Among 4 Cognitive Performance Assessment Battery measures, only power of attention declined significantly more with lemborexant treatment compared with placebo in 1 of 2 studies, whereas zolpidem differed from placebo on multiple measures. On the highway-driving test, lemborexant did not significantly impair driving performance versus placebo, however, zopiclone did differ. In large phase 3 trials, next-morning sleep diary ratings showed significantly greater alertness with lemborexant compared with placebo after up to 6 months of treatment. As expected, somnolence was the most common adverse event reported with lemborexant treatment. Somnolence was typically mild to moderate in severity and rarely caused discontinuation of study drug.
CONCLUSION


Across 9 clinical studies, lemborexant did not substantially impair next-day functioning among healthy subjects and subjects with insomnia.",2020,"On the highway-driving test, lemborexant did not significantly impair driving performance versus placebo, however, zopiclone did differ.","['insomnia', 'healthy subjects or subjects with insomnia disorder treated with', 'healthy subjects and subjects with insomnia']","['Lemborexant', 'placebo', 'lemborexant']","['next-morning postural stability (body sway measured by ataxiameter), cognitive performance (Cognitive Performance Assessment Battery), impact on driving (standard deviation of lateral position during highway driving test), subjective sleepiness (sleep diary entries), and adverse events of somnolence', 'Somnolence', 'power of attention', 'driving performance', 'postural stability']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0567410', 'cui_str': 'Highway environment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0664147,"On the highway-driving test, lemborexant did not significantly impair driving performance versus placebo, however, zopiclone did differ.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation , New York, New York, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Yardley', 'Affiliation': 'Neurobiology Business Group, Eisai Ltd ., Hatfield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pinner', 'Affiliation': 'Neurobiology Business Group, Eisai Ltd ., Hatfield, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Perdomo', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Jocelyn Y', 'Initials': 'JY', 'LastName': 'Cheng', 'Affiliation': 'Neurobiology Business Group, Eisai Inc ., Woodcliff Lake, New Jersey, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1823724']
1518,33119861,"Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.","BACKGROUND


Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48.
METHODS


Eligible patients (N = 353) were randomized 1:1 to receive subcutaneous (sc) SDZ-ADL 40 mg (n = 177) or ref-ADL (n = 176) every other week from Week 0 to Week 24. At Week 24, all patients with at least a moderate response by Disease Activity Score-28 including high-sensitivity C-reactive protein (DAS28-CRP) in the SDZ-ADL group continued SDZ-ADL (n = 159), and in the ref-ADL group were switched to SDZ-ADL (n = 166), treated for up to 46 weeks. The primary endpoint was change in DAS28-CRP from baseline at Week 12. Other efficacy endpoints included proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity.
RESULTS


The DAS28-CRP score changes from baseline at Week 12 were similar between SDZ-ADL (- 2.16) and ref-ADL (- 2.18) with a mean difference (95% CI) of 0.02 (- 0.24 to 0.27), which was within the pre-specified equivalence margin of ± 0.6. After switching treatment from ref-ADL to SDZ-ADL, the mean DAS28-CRP change was similar between the SDZ-ADL and 'ref-ADL/switched SDZ-ADL' group (- 3.09 vs - 3.05). The proportion of patients with good/moderate EULAR response was 69.2%/29.0% in the SDZ-ADL group and 68.0%/29.6% in the 'ref-ADL/switched SDZ-ADL' group. The proportion of patients in EULAR remission was 51.4% and 54.4% and in Boolean remission was 16.8% and 21.6% for SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups, respectively. The secondary endpoints were similar across the treatment groups. The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity. Antidrug antibodies were detected in 24.2% and 25.6% of patients treated with SDZ-ADL and 'ref-ADL/switched SDZ-ADL', respectively, from baseline to Week 48, of which 72.5% in SDZ-ADL and 79.1% in 'ref-ADL/switched SDZ-ADL' groups were neutralizing.
CONCLUSIONS


In patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755).",2020,"The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity.","['patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including', 'Patients with Moderate-to-Severe Active Rheumatoid Arthritis', 'Eligible patients (N\u2009=\u2009353']","['Biosimilar SDZ-ADL', 'methotrexate (MTX', 'Sandoz adalimumab SDZ-ADL (GP-2017', 'subcutaneous (sc) SDZ-ADL 40\xa0mg (n\u2009=\u2009177) or ref-ADL', 'SDZ-ADL']","['proportion of patients in EULAR remission', 'efficacy, safety and immunogenicity', 'change in DAS28-CRP', 'proportion of patients with good/moderate EULAR response', 'efficacy, safety and immunogenicity comparability data', 'Antidrug antibodies', 'incidence of adverse events (AEs) and injection-site reactions', 'mean DAS28-CRP change', 'Efficacy', 'proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity', 'DAS28-CRP score changes', 'Boolean remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",353.0,0.0911073,"The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wiland', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland. pwiland1@gmail.com.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Jeka', 'Affiliation': 'Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum UMK, Bydgoszcz, Poland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilová', 'Affiliation': 'MEDICAL PLUS s.r.o., University of Veterinary and Pharmaceutical sciences, Faculty of Pharmacy, Uherske Hradiste, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Brandt-Jürgens', 'Affiliation': 'Rheumatology Private Practice, Berlin, Germany.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Miranda Limón', 'Affiliation': 'RM Pharma Specialists, Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cantalejo Moreira', 'Affiliation': 'Unidad de Reumatología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Raul Veiga', 'Initials': 'RV', 'LastName': 'Cabello', 'Affiliation': 'Hospital Central de la Defensa, Glorieta Ejército, 1, 28047, Madrid, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jauch-Lembach', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Thakur', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Halimuniyazi', 'Initials': 'H', 'LastName': 'Haliduola', 'Affiliation': 'Global Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Brueckmann', 'Affiliation': 'Global Medical Affairs, Biopharmaceutical, Hexal AG (A Sandoz Company), Holzkirchen, Germany.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Gaylis', 'Affiliation': 'Arthritis and Rheumatic Disease Specialties, Aventura, FL, USA.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00447-6']
1519,33120324,The effects of the Fordyce's 14 fundamentals for happiness program on happiness and caregiver burden among the family caregivers of patients with epilepsy: A randomized controlled trial.,"BACKGROUND


Caregiving to patients with epilepsy (PWE) is often very stressful for family caregivers and puts a heavy caregiver burden (CB) on them. The aim of this study was to evaluate the effects of Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE.
METHODS


This randomized controlled trial was conducted on seventy family caregivers of PWE. Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran, and randomly allocated to either an intervention or a control group. Participants in the control group received conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions. Happiness and CB in both groups were assessed at three time points, namely before, immediately after, and two months after the intervention. Data were analyzed using the SPSS program (v. 18.0).
FINDINGS


There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05). The mean scores of happiness and CB in the control group did not significantly change (P > 0.05), while the mean score of happiness significantly increased and the mean score of CB significantly decreased in the intervention group across the three measurement time points (P < 0.05). Consequently, the mean score of happiness in the intervention group was significantly greater than the control group and the mean score of CB in the intervention group was significantly less than the control group at both posttests (P < 0.01).
CONCLUSION


The Fordyce's fourteen Fundamentals for Happiness Program is effective in significantly increasing happiness and reducing CB among the family caregivers of PWE. Healthcare providers and policy makers can use this program to reduce problems among these family caregivers.",2020,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"['Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran', ""Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE"", 'patients with epilepsy (PWE', 'seventy family caregivers of PWE', 'family caregivers of patients with epilepsy']","['happiness program', ""conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions""]","['mean scores of happiness and CB', 'happiness and caregiver burden', 'mean score of happiness', 'mean score of CB', 'Happiness and CB']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",70.0,0.0376502,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"[{'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: Leila_rabiei@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Lotfizadeh', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoud_lotfizadeh@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: zzkkarimmi@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoodi1383@yahoo.com.'}]",Seizure,['10.1016/j.seizure.2020.10.013']
1520,33120766,"Dexmedetomidine-remifentanil vs propofol-remifentanil for monitored anesthesia care during hysteroscopy: Randomized, single-blind, controlled trial.","BACKGROUND


Although dexmedetomidine has been used as either the anesthetic agent for light sedation or as an adjunct to other sedatives, no study has investigated the usefulness of dexmedetomidine as the main sedative agent for invasive and painful procedures. The purpose of this study was to compare the safety of dexmedetomidine-remifentanil and propofol-remifentanil during monitored anesthesia care (MAC) for hysteroscopy.
METHODS


Female patients undergoing hysteroscopy were randomly assigned to either the dexmedetomidine (group D) or the propofol group (group P). The study drug (0.6 ml/kg; dexmedetomidine 2 μg/ml or propofol 4 mg/ml) was loaded for 10 minutes followed by 0.1 to 0.5 ml/kg/hour to maintain a bispectral index of 60 to 80 during the procedure. In both groups, remifentanil was infused using a target-controlled-infusion system with a target concentration of 2 ng/ml and titrated during the procedure. The incidence rates of intraoperative respiratory depression in both groups were compared. Postoperative pain and patients satisfaction were also compared.
RESULTS


A total of 69 female patients were included in this study. Dexmedetomidine significantly decrease the incidence of respiratory depression compared with propofol (15/34 [44.1%] vs 5/35 [14.3%], P = .006, group P and D, respectively). Postoperative pain and patients satisfaction score did not differ between the groups.
CONCLUSION


The combination of dexmedetomidine-remifentanil can reduce the incidence of respiratory depression without increasing hemodynamic complications compared with propofol-remifentanil for MAC during hysteroscopy.",2020,"Dexmedetomidine significantly decrease the incidence of respiratory depression compared with propofol (15/34 [44.1%] vs 5/35 [14.3%], P = .006, group P and D, respectively).","['Female patients undergoing hysteroscopy', 'monitored anesthesia care during hysteroscopy', '69 female patients']","['dexmedetomidine-remifentanil and propofol-remifentanil', 'propofol-remifentanil', 'propofol', 'Dexmedetomidine', 'dexmedetomidine', 'remifentanil', 'dexmedetomidine-remifentanil', 'Dexmedetomidine-remifentanil vs propofol-remifentanil', 'dexmedetomidine 2\u200aμg/ml or propofol']","['Postoperative pain and patients satisfaction', 'incidence rates of intraoperative respiratory depression', 'Postoperative pain and patients satisfaction score', 'incidence of respiratory depression']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",69.0,0.108515,"Dexmedetomidine significantly decrease the incidence of respiratory depression compared with propofol (15/34 [44.1%] vs 5/35 [14.3%], P = .006, group P and D, respectively).","[{'ForeName': 'Seongjoo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Soo-Lyoen', 'Initials': 'SL', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Francis Sahngun', 'Initials': 'FS', 'LastName': 'Nahm', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Do', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do.'}]",Medicine,['10.1097/MD.0000000000022712']
1521,33120774,Efficacy of a single injection compared with triple injections using a costoclavicular approach for infraclavicular brachial plexus block during forearm and hand surgery: A randomized controlled trial.,"OBJECTIVES


It was recently proposed that a costoclavicular (CC) approach can be used in ultrasound (US)-guided infraclavicular brachial plexus block (BPB). In this study, we hypothesized that triple injections in each of the 3 cords in the CC space would result in a greater spread in the 4 major terminal nerves of the brachial plexus than a single injection in the CC space without increasing the local anesthetic (LA) volume.
METHODS


Sixty-eight patients who underwent upper extremity surgery randomly received either a single injection (SI group, n = 34) or a triple injection (TI group, n = 34) using the CC approach. Ten milliliters of 2% lidocaine, 10 mL of 0.75% ropivacaine, and 5 mL of normal saline were used for BPB in each group (total 25 mL). Sensory-motor blockade of the ipsilateral median, radial, ulnar, and musculocutaneous nerves was assessed by a blinded observer at 5 minutes intervals for 30 minutes immediately after LA administration.
RESULTS


Thirty minutes after the block, the blockage rate of all 4 nerves was significantly higher in the TI group than in the SI group (52.9% in the SI group vs 85.3% in the TI group, P = .004). But there was no significant difference in the anesthesia grade between the 2 groups (P = .262). The performance time was similar in the 2 groups (3.0 ± 0.9 minutes in the SI group vs 3.2 ± 1.2 minutes in the TI group, respectively; P = .54).
DISCUSSION


The TI of CC approach increased the consistency of US-guided infraclavicular BPB in terms of the rate of blocking all 4 nerves without increasing the procedure time despite administering the same volume of the LA.",2020,"Thirty minutes after the block, the blockage rate of all 4 nerves was significantly higher in the TI group than in the SI group (52.9% in the SI group vs 85.3% in the TI group, P = .004).","['Sixty-eight patients who underwent upper extremity surgery randomly received either a', 'infraclavicular brachial plexus block during forearm and hand surgery']","['costoclavicular approach', 'lidocaine, 10\u200amL of 0.75% ropivacaine, and 5\u200amL of normal saline', 'single injection (SI group, n\u200a=\u200a34) or a triple injection (TI group, n\u200a=\u200a34) using the CC approach']","['performance time', 'anesthesia grade', 'local anesthetic (LA) volume', 'Sensory-motor blockade of the ipsilateral median, radial, ulnar, and musculocutaneous nerves', 'blockage rate of all 4 nerves']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0026855', 'cui_str': 'Structure of musculocutaneous nerve'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]",68.0,0.0500867,"Thirty minutes after the block, the blockage rate of all 4 nerves was significantly higher in the TI group than in the SI group (52.9% in the SI group vs 85.3% in the TI group, P = .004).","[{'ForeName': 'Mi Geum', 'Initials': 'MG', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University College of Medicine, Gil Medical Center, Incheon.'}, {'ForeName': 'Doo Yeon', 'Initials': 'DY', 'LastName': 'Go', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}, {'ForeName': 'Sung Uk', 'Initials': 'SU', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}, {'ForeName': 'Yun Suk', 'Initials': 'YS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, JeJu National University College of Medicine, Jeju Hospital, Jeju, Republic of Korea.'}, {'ForeName': 'Hyeon Ju', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University College of Medicine, Anam Hospital, Seoul.'}]",Medicine,['10.1097/MD.0000000000022739']
1522,33121984,Bleaching toothpaste with two different concentrations of hydrogen peroxide: A randomized double-blinded clinical trial.,"OBJECTIVES


This randomized double-blinded clinical trial evaluated the bleaching efficacy and incidence of contact hypersensitivity of three kinds of bleaching toothpaste.
METHODS


Forty-nine participants above A2 shade on the maxillary central incisor (#11) and canine (#13) were randomized into three groups: TW group (n = 15), 0.75 % HP-containing toothpaste (Toothwhole white); VL group (n = 15), 0.75 % HP-containing toothpaste (Vussen 7); and VH group (n = 17), 2.8 % of HP-containing toothpaste (Vussen 28). Participants were instructed to manually brush their teeth for 3 min, 3 times per day for 12 weeks. They were followed-up after 4 and 12 weeks. Shade measurements were performed using a spectrophotometer (SP), and data were calculated with CIELab (ΔE ab * ) and CIEDE2000 (ΔE 00 ) formula. Additionally, visual inspection (VI) using the Vitapan classical shade guide was also performed, and the correlation between the two measurements was analyzed by comparing the CIELab (ΔE ab * ) values. The incidence of contact hypersensitivity at each follow-up was recorded. A mixed-effect model was performed to assess shade changes and chi-square tests for the incidence of contact hypersensitivity, respectively.
RESULTS


At 12 week follow-up, all groups showed ΔE ab *   above 3.46, and ΔE 00  above 2.25 for tooth #11. For tooth #13, the ΔE ab *  and ΔE 00  of VH and TW groups only were above those thresholds. Shade change varied according to toothpaste and follow-up points. SP and VI showed a moderate positive correlation for L*, a*, and b*, respectively (P < 0.05). Contact hypersensitivity was not significantly different among the groups (P > 0.05).
CONCLUSIONS


Bleaching toothpaste with higher HP yields a better shade change than other toothpaste after 12 weeks.
CLINICAL SIGNIFICANCE


The use of bleaching toothpaste with a higher HP concentration results in a better shade improvement.",2020,"Contact hypersensitivity was not significantly different among the groups (P > 0.05).
",['Forty-nine participants above A2 shade on the maxillary central incisor (#11) and canine (#13'],"['Bleaching toothpaste', 'HP-containing toothpaste (Toothwhole white); VL group (n\u2009=\u200915), 0.75% HP-containing toothpaste', 'HP-containing toothpaste', 'hydrogen peroxide', 'bleaching toothpaste']","['Contact hypersensitivity', 'incidence of contact hypersensitivity']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0162351', 'cui_str': 'Contact hypersensitivity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",49.0,0.12685,"Contact hypersensitivity was not significantly different among the groups (P > 0.05).
","[{'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Kyung Hee University Dental Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Dongseok', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea; Division of Biostatistics, Oregon Health and Science University, Portland State University of Public Health, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Jei', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Shim', 'Affiliation': 'Department of Conservative Dentistry, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Duck-Su', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': 'Department of Conservative Dentistry, School of Dentistry, Kyung Hee University, Seoul, Republic of Korea. Electronic address: dentist96@khu.ac.kr.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103508']
1523,33127531,"Association between levosimendan, postoperative AKI, and mortality in cardiac surgery: Insights from the LEVO-CTS trial.","OBJECTIVES


We aimed to evaluate the association between levosimendan treatment and acute kidney injury (AKI) as well as assess the clinical sequelae of AKI in cardiac surgery patients with depressed left ventricular function (ejection fraction <35%).
METHODS


Patients in the LEVO-CTS trial undergoing on-pump coronary artery bypass grafting (CABG), valve, or CABG/valve surgery were stratified by occurrence and severity of postoperative AKI using the AKIN classification. The association between levosimendan infusion and AKI was modeled using multivariable regression.
RESULTS


Among 854 LEVO-CTS patients, 231 (27.0%) experienced postoperative AKI, including 182 (21.3%) with stage 1, 35 (4.1%) with stage 2, and 14 (1.6%) with stage 3 AKI. The rate of AKI was similar between patients receiving levosimendan or placebo. The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% confidence interval [CI] 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4). No association was observed between levosimendan, AKI stage, and odds of 30-day mortality (interaction P = .69). Factors independently associated with AKI included increasing age, body mass index, diabetes, and increasing baseline systolic blood pressure. Increasing baseline eGFR and aldosterone antagonist use were associated with a lower risk of AKI.
CONCLUSIONS


Postoperative AKI is common among high-risk patients undergoing cardiac surgery and associated with significantly increased risk of 30-day death or dialysis. Levosimendan was not associated with the risk of AKI.",2020,"The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% CI 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4).","['cardiac surgery', 'cardiac surgery patients with depressed LV function (ejection fraction < 35', 'Patients in the LEVO-CTS trial undergoing on-pump coronary artery bypass grafting (CABG), valve, or CABG/valve surgery']","['levosimendan or placebo', 'levosimendan', 'Levosimendan']","['baseline systolic blood pressure', 'risk of AKI', 'rate of AKI', 'risk of 30-day death or dialysis', '30-day mortality', 'levosimendan, AKI stage, and odds of 30-day mortality', 'postoperative AKI']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.202536,"The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% CI 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4).","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Stebbins', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Raman', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'van Diepen', 'Affiliation': 'Department of Critical Care and Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'Department of Anesthesia, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fremes', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whitlock', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Meyer', 'Affiliation': 'Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Rajendra H', 'Initials': 'RH', 'LastName': 'Mehta', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stafford-Smith', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2020.10.066']
1524,33128347,"Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis.","OBJECTIVE


This study aimed to evaluate the safety of avacopan, an orally administered C5a receptor inhibitor, for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis in addition to standard-of-care (SOC) treatment with glucocorticoids with cyclophosphamide or rituximab.
METHODS


In this randomized 12-week study, twice daily avacopan (10 mg or 30 mg) plus SOC was assessed versus SOC only in patients with newly diagnosed/relapsing ANCA-associated vasculitis. Efficacy measurements included 50% or greater reduction in Birmingham Vasculitis Activity Score (BVAS) at day 85, rapid reduction (day 29) of BVAS to a score of 0 that was sustained through day 85, change in Vasculitis Damage Index (VDI), renal response (improvement in estimated glomerular filtration rate [eGFR], hematuria, and albuminuria), and health-related quality of life (HRQoL).
RESULTS


Forty-two patients were randomized (n = 13 SOC, n = 13 avacopan 10 mg, and n = 16 avacopan 30 mg). Serious adverse events occurred in 15% and 17% of patients receiving SOC only and patients receiving avacopan with SOC, respectively. In the intent-to-treat population, BVAS response was high across arms (11 of 13 SOC, 11 of 12 avacopan 10 mg, and 12 of 15 avacopan 30 mg); increases in mean VDI were greater with SOC only than with avacopan plus SOC (0.3 versus 0.1). Avacopan 30 mg was numerically superior to placebo and avacopan 10 mg in early remission (15%, 8%, and 20% for SOC only, avacopan 10 mg, and avacopan 30 mg, respectively), improved eGFR (+2.0 ml/min/1.73m 2  , +1.3 ml/min/1.73m 2  , and +6.2 ml/min/1.73m 2  , respectively), renal response (17%, 40%, and 63%, respectively), and measures of HRQoL.
CONCLUSION


Avacopan in addition to SOC for ANCA-associated vasculitis was well tolerated, and at the higher study dose, it appeared to improve time to remission (ClinicalTrials.gov identifier NCT02222155).",2020,"Serious adverse events occurred in 15% and 17% of patients receiving SOC only and patients receiving avacopan with SOC, respectively.","['patients with newly diagnosed/relapsing ANCA-associated vasculitis', 'Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis']","['glucocorticoids with cyclophosphamide or rituximab', 'C5a receptor inhibitor', 'Avacopan, an Oral C5a Receptor Inhibitor', 'avacopan', 'Avacopan', 'placebo and avacopan', 'avacopan plus SOC']","['renal response', 'BVAS response', 'Serious adverse events', 'eGFR', 'time to remission', 'mean VDI', 'Birmingham Vasculitis Activity Score (BVAS', 'vasculitis', 'Vasculitis Damage Index (VDI), renal response (improvement in estimated glomerular filtration rate [eGFR], hematuria, and albuminuria), and health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0103647', 'cui_str': 'Anti neutrophilic cytoplasm antibody'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0056196', 'cui_str': 'Lymphocyte antigen CD88'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4507514', 'cui_str': 'avacopan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",42.0,0.0814434,"Serious adverse events occurred in 15% and 17% of patients receiving SOC only and patients receiving avacopan with SOC, respectively.","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Niles', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jimenez', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, New York, United States.'}, {'ForeName': 'Brad H', 'Initials': 'BH', 'LastName': 'Rovin', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bomback', 'Affiliation': 'Columbia University, New York, New York, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Potarca', 'Affiliation': 'ChemoCentryx, Inc., Mountain View, California, United States.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schall', 'Affiliation': 'ChemoCentryx, Inc., Mountain View, California, United States.'}, {'ForeName': 'Pirow', 'Initials': 'P', 'LastName': 'Bekker', 'Affiliation': 'ChemoCentryx, Inc., Mountain View, California, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",ACR open rheumatology,['10.1002/acr2.11185']
1525,33128912,"Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial.","BACKGROUND


Despite intracerebral haemorrhage causing 5% of deaths worldwide, few evidence-based therapeutic strategies other than stroke unit care exist. Tranexamic acid decreases haemorrhage in conditions such as acute trauma and menorrhoea. We aimed to assess whether tranexamic acid reduces intracerebral haemorrhage growth in patients with acute intracerebral haemorrhage.
METHODS


We did a prospective, double-blind, randomised, placebo-controlled, investigator-led, phase 2 trial at 13 stroke centres in Australia, Finland, and Taiwan. Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography. Patients were randomly assigned (1:1) to receive either 1 g of intravenous tranexamic acid over 10 min followed by 1 g over 8 h or matching placebo, started within 4·5 h of symptom onset. Randomisation was done using a centralised web-based procedure with randomly permuted blocks of varying size. All patients, investigators, and staff involved in patient management were masked to treatment. The primary outcome was intracerebral haemorrhage growth (>33% relative or >6 mL absolute) at 24 h. The primary and safety analyses were done in the intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT01702636).
FINDINGS


Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the tranexamic acid group (n=50) or the placebo group (n=50). Median age was 71 years (IQR 57-79) and median intracerebral haemorrhage volume was 14·6 mL (7·9-32·7) at baseline. The primary outcome was not different between the two groups: 26 (52%) patients in the placebo group and 22 (44%) in the tranexamic acid group had intracerebral haemorrhage growth (odds ratio [OR] 0·72 [95% CI 0·32-1·59], p=0·41). There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications. None of the deaths was considered related to study medication.
INTERPRETATION


Our study does not provide evidence that tranexamic acid prevents intracerebral haemorrhage growth, although the treatment was safe with no increase in thromboembolic complications. Larger trials of tranexamic acid, with simpler recruitment methods and an earlier treatment window, are justified.
FUNDING


National Health and Medical Research Council, Royal Melbourne Hospital Foundation.",2020,There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications.,"['Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography', 'patients with acute intracerebral haemorrhage', 'Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the', '13 stroke centres in Australia, Finland, and Taiwan', 'patients with intracerebral haemorrhage (STOP-AUST']","['intravenous tranexamic acid', 'placebo', 'tranexamic acid', 'Tranexamic acid']","['median intracerebral haemorrhage volume', 'thromboembolic complications', 'intracerebral haemorrhage growth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449867', 'cui_str': 'Use of anticoagulation'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",100.0,0.776123,There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications.,"[{'ForeName': 'Atte', 'Initials': 'A', 'LastName': 'Meretoja', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Neurology, Helsinki University Hospital, Helsinki, Finland. Electronic address: atte.meretoja@hus.fi.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; New Zealand Brain Research Institute, Christchurch, New Zealand.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Mathematics and Statistics, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Gerli', 'Initials': 'G', 'LastName': 'Sibolt', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jiann-Shing', 'Initials': 'JS', 'LastName': 'Jeng', 'Affiliation': 'Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Spratt', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Department of Neurology, Austin Hospital, Heidelberg, VIC, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Department of Neurology, Western Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Der-Yang', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Department of Neurosurgery, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Monash University, Melbourne, VIC, Australia; Department of Clinical Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Thanh', 'Initials': 'T', 'LastName': 'Phan', 'Affiliation': 'Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Department of Neurosciences, Eastern Health Medical School, Monash University, Melbourne, VIC, Australia; Ambulance Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moey', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Aviv', 'Affiliation': 'Department of Radiology, Neuroradiology Section, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Christen D', 'Initials': 'CD', 'LastName': 'Barras', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; South Australian Health and Medical Research Institute, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Curtze', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Strbian', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sung-Chun', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia; Sydney Partnership for Health, Education, Research and Enterprise (SPHERE), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30369-0']
1526,33128939,Rare Functional Variants Associated with Antidepressant Remission in Mexican-Americans: Short title: Antidepressant remission and pharmacogenetics in Mexican-Americans.,"INTRODUCTION


Rare genetic functional variants can contribute to 30-40% of functional variability in genes relevant to drug action. Therefore, we investigated the role of rare functional variants in antidepressant response.
METHOD


Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD) participated in a prospective randomized, double-blind study with desipramine or fluoxetine. The rare variant analysis was performed using whole-exome genotyping data. Network and pathway analyses were carried out with the list of significant genes.
RESULTS


The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01). Pathway analysis of these genes supports the involvement of the following gene ontology processes: olfactory/sensory transduction, regulation of response to cytokine stimulus, and meiotic cell cycleprocess.
LIMITATIONS


Our study did not have a placebo arm. We were not able to use antidepressant blood level as a covariate. Our study is based on a small sample size of only 65 Mexican-American individuals. Further studies using larger cohorts are warranted.
CONCLUSION


Our data identified several rare functional variants in antidepressant drug response in MDD patients. These have the potential to serve as genetic markers for predicting drug response.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00265291.",2020,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","['Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD', '65 Mexican-American individuals', 'MDD patients', 'Mexican-Americans']",['desipramine or fluoxetine'],['Antidepressant remission and pharmacogenetics'],"[{'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]",,0.0426557,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","[{'ForeName': 'Ma-Li', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: wongma@upstate.edu.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arcos-Burgos', 'Affiliation': 'Grupo de Investigación en Psiquiatría, Departamento de Psiquiatría, Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellin, Antioquia, Colombia.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Alice W', 'Initials': 'AW', 'LastName': 'Licinio', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Eunice W M', 'Initials': 'EWM', 'LastName': 'Chin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Yao', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Xin-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Department of Neuroscience & Regenerative Medicine, Medical College of Georgia at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Bornstein', 'Affiliation': 'Medical Clinic III, Carl Gustav Carus University Hospital, Dresden University of Technology, Dresden, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Licinio', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: licinioJ@upstate.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.027']
1527,33129156,Worry impairs the problem-solving process: Results from an experimental study.,"INTRODUCTION


Many individuals believe that worry helps solve real-life problems. Some researchers also purport that nonpathological worry can aid problem solving. However, this is in contrast to evidence that worry impairs cognitive functioning.
OBJECTIVE


This was the first study to empirically test the effects of a laboratory-based worry induction on problem-solving abilities.
PROCEDURE


Both high (n = 96) and low (n = 89) trait worriers described a current problem in their lives. They were then randomly assigned to contemplate their problem in a worrisome (n = 60) or objective (n = 63) manner or to engage in a diaphragmatic breathing task (n = 62). All participants subsequently generated solutions and then selected their most effective solution. Next, they rated their confidence in the solution's effectiveness, their likelihood to implement the solution, and their current anxiety/worry. Experimenters uninformed of condition also rated solution effectiveness.
RESULTS


The worry induction led to lower reported confidence in solutions for high trait worry participants, and lower experimenter-rated effectiveness of solutions for all participants, relative to objective thinking. Further, state worry predicted less reported intention to implement solutions, while controlling for trait worry. Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
CONCLUSIONS


Overall, the worry induction impaired problem solving on multiple levels, and this was true for both high and low trait worriers.",2020,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
",[],"['worrisome (n\xa0=\xa060) or objective (n\xa0=\xa063) manner or to engage in a diaphragmatic breathing task', 'laboratory-based worry induction']",['elevated worry and anxiety'],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",96.0,0.0612885,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Llera', 'Affiliation': 'Department of Psychology, Towson University, 8000 York Road, Towson, MD, 21252, USA. Electronic address: sllera@towson.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, 140 Moore Building, University Park, PA, 16801, USA. Electronic address: mgn1@psu.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103759']
1528,33143512,"Expression of concern: Comparison of myo-inositol and metformin on mental health parameters and biomarkers of oxidative stress in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial  and  The effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of patients with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.",,2020,,"['patients with polycystic ovary syndrome', 'women with polycystic ovary syndrome']","['fish oil omega-3 fatty acid supplementation', 'placebo', 'myo-inositol and metformin']","['mental health parameters and metabolic status', 'oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.761239,,[],Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2020.1842508']
1529,33143987,Pediatric Primary Care Provider Perspectives on a Computer-Facilitated Screening and Brief Intervention System for Adolescent Substance Use.,"PURPOSE


This study aimed to elicit pediatric primary care providers' (PCPs) feedback on the acceptability and feasibility of implementing a tablet computer-facilitated Screening and Brief Intervention (cSBI) system for adolescent substance use in their practices.
METHODS


We trained PCPs at five Boston area practices and enrolled their 12- to 18-year-old patients in a pilot randomized trial of cSBI versus usual care. PCPs completed an 18-item poststudy questionnaire. We computed frequencies and thematically coded open-ended responses.
RESULTS


The analysis sample included 49 of 54 participating PCPs (90.7%). Overall, 89.8% of participants agreed the cSBI system was useful, and 81.6% reported increased confidence in providing brief counseling. Most useful were the immediate availability of screen results, talking points on substance use risks, and counseling prompts. Challenges included time and unfamiliarity with tablet computers. Many suggested electronic health record integration of cSBI to improve efficiency.
CONCLUSIONS


cSBI showed high acceptability and increased confidence among pediatric PCPs. Feasibility could be enhanced by electronic health record integration.",2020,"Overall, 89.8% of participants agreed the cSBI system was useful, and 81.6% reported increased confidence in providing brief counseling.","['We trained PCPs at five Boston area practices and enrolled their 12- to 18-year-old patients', 'adolescent substance use in their practices']","['cSBI versus usual care', 'implementing a tablet computer-facilitated Screening and Brief Intervention (cSBI) system', 'Computer-Facilitated Screening and Brief Intervention System']",['confidence in providing brief counseling'],"[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0576502,"Overall, 89.8% of participants agreed the cSBI system was useful, and 81.6% reported increased confidence in providing brief counseling.","[{'ForeName': 'Erin B', 'Initials': 'EB', 'LastName': 'Gibson', 'Affiliation': 'Division of General Internal Medicine, Boston Medical Center, Charlestown, Massachusetts. Electronic address: erin.gibson@bmc.org.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Knight', 'Affiliation': ""The Center for Adolescent Substance Use and Addiction Research (CeASAR), Boston Children's Hospital, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, California.'}, {'ForeName': 'Lon', 'Initials': 'L', 'LastName': 'Sherritt', 'Affiliation': ""The Center for Adolescent Substance Use and Addiction Research (CeASAR), Boston Children's Hospital, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Harris', 'Affiliation': ""The Center for Adolescent Substance Use and Addiction Research (CeASAR), Boston Children's Hospital, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.""}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.09.037']
1530,33120137,Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial.,"BACKGROUND


Intimate partner violence constitutes a serious health problem worldwide. To date the evidence is sparse on whether intimate partner violence group interventions could improve mental health outcomes among perpetrators and their partners.
OBJECTIVES


To compare the effectiveness of nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy in improving reported mental health outcomes and emotion regulation at 12 months' follow-up amongst perpetrators who voluntarily seek help for violence in intimate partnerships.
DESIGN


A randomised controlled trial.
PARTICIPANTS


A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study.
METHODS


The participants were randomly assigned to cognitive-behavioural group therapy (intervention group, N = 67) or mindfulness-based stress reduction group therapy (comparator group, N = 58). The pre-defined outcomes were symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale at 12 months' follow-up.
RESULTS


A reduction of symptoms of anxiety and depression was reported, with no between-group differences (intervention group: coefficient: - 0.17, P = 0.009; comparator group: coefficient: - 0.13, P = 0.036). Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0. 34, P = <0.001).
CONCLUSION


Even though there was reduction in symptoms in both groups at 12 months' follow-up with no between-group differences, the total symptom scores remained high in both groups.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01653860.",2020,"Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0.","['A total of 125 persons at an outpatient service run by a University Hospital in Norway for men who perpetrate intimate partner violence were enroled in the study', 'men who perpetrate intimate partner violence']","['nurse-led cognitive-behavioural group therapy vs. mindfulness-based stress reduction group therapy', 'cognitive behavioural therapy or mindfulness-based therapy', 'cognitive-behavioural group therapy (intervention group, N\xa0=\xa067) or mindfulness-based stress reduction group therapy (comparator group, N\xa0=\xa058']","['symptoms of anxiety and depression', 'mental health outcomes', 'symptoms of anxiety and depression as reported by the Hopkins Symptom Checklist 25 and general emotion regulation as reported by Difficulties in Emotion Regulation Scale', 'mental health and emotion regulation', 'reduction in symptoms', 'Difficulties in Emotion Regulation Scale scores', 'total symptom scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086751', 'cui_str': 'Outpatient service'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",125.0,0.0825749,"Both groups had a small but statistically significant reduction in the Difficulties in Emotion Regulation Scale scores at 12 months' follow-up (intervention group: coefficient: - 0.47, P = <0.001; comparator group: coefficient: - 0.","[{'ForeName': 'Merete Berg', 'Initials': 'MB', 'LastName': 'Nesset', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: merete.b.nesset@ntnu.no.""}, {'ForeName': 'Johan Håkon', 'Initials': 'JH', 'LastName': 'Bjørngaard', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Social Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Johan.H.Bjorngaard@ntnu.no.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whittington', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Richard.Whittington@ntnu.no.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Palmstierna', 'Affiliation': ""Forensic Department and Research Centre Brøset, St. Olav's Hospital, Trondheim University Hospital, PO 1803 Lade, N-7440 Trondheim, Norway; Faculty of Medicine and Health Sciences, Department of Mental Health, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: Tom.Palmstierna@ki.se.""}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103795']
1531,33120195,"Effect of an educational intervention delivered by pharmacists on adherence to treatment, disease control and lung function in patients with asthma.","BACKGROUND


Lack of therapeutic adherence is a relevant problem in clinical practice and it can be assessed via validated tools such as the Test of Adherence to Inhalers (TAI). Education on the correct use of inhaler devices has been associated with improvement in adherence. Many studies highlighted the pivotal role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases.
OBJECTIVE


To evaluate the effectiveness on adherence and clinical parameters of an educational intervention administered by clinical pharmacists (CPs) to patients with asthma on long-term inhalation therapy.
METHODS


A prospective comparative study involving 34 community pharmacies in Italy (23 intervention, 11 control). Enrolled subjects were evaluated for adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function at baseline and after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists.
RESULTS


A total of 242 consecutive subjects (167 intervention, 75 control) were enrolled. There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit. Patients with baseline ACT≥20 maintained disease control more frequently in the intervention group compared to the control arm (95% vs 79.5%, p = 0.004). Conclusions through administration of TAI-driven educational interventions addressing both technical and psychological issues, trained CPs can help improve adherence to treatment and asthma control.",2020,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","['242 consecutive subjects (167 intervention, 75 control) were enrolled', '34 community pharmacies in Italy (23 intervention, 11 control', 'patients with asthma on long-term inhalation therapy', 'patients with asthma']","['educational intervention administered by clinical pharmacists (CPs', 'educational intervention']","['disease control', 'TAI score, ACT and lung function parameters', 'adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]",34.0,0.0251079,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Paoletti', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Keber', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Heffler', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy. Electronic address: enrico.heffler@hunimed.eu.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Malipiero', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baiardini', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Giua', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine,['10.1016/j.rmed.2020.106199']
1532,33120482,"[A multicenter, randomized, open and positive parallel controlled clinical study of clotrimazole vaginal expansion suppository and vaginal tablet in the treatment of mild and moderate vulvovaginal candidiasis].","Objective:  Using clotrimazole vaginal tablet as a positive control, to evaluate the results of clotrimazole vaginal expansion suppository in the treatment of mild and moderate vulvovaginal candidiasis in terms of efficacy, patient satisfaction, side effects, and recurrence rate.  Methods:  This study was jointly conducted by 5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected. They were randomized to experimental group and control group as 1∶1 ratio. In the experimental group ( n =105), the subjects applied clotrimazole vaginal expansion suppository (150 mg) daily at night for 7 days. In the control group ( n =106), the subjects used a single dose of clotrimazole vaginal tablet (500 mg). Follow-ups were performed at (8±3) and (30±5) days after the discontinuation of the drugs, respectively. The difference in clinical symptoms and signs scores was used to evaluate the improvement of clinical symptoms, and the patient's satisfaction and side effects were recorded.  Results:  At the first follow-up, the experimental group and control group were followed up by fungal culture on the cure rate [66.7% (70/105) versus 63.2% (67/106),  P >0.05] and total effective rate [98.1% (103/105) versus 99.1% (105/106),  P >0.05], the differences were not statistically significant. At the second follow-up, the recurrence rates of the experimental group and the control group were 5.7% (4/70) and 14.9% (10/67), respectively, with no significant difference ( P >0.05). In the evaluation of patient satisfaction, the leakage of the drug in the experimental group was significantly better than that in the control group ( P <0.01). The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070,  P =0.586).  Conclusions:  In the treatment of mild and moderate vulvovaginal candidiasis, clotrimazole vaginal expansion suppository is no less effective than clotrimazole vaginal tablet, and there is no significant difference in the recurrence rate between the two. In terms of patient satisfaction, clotrimazole vaginal expansion suppository is superior to clotrimazole vaginal tablet.",2020,"The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070,  P =0.586).  ","['5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected', 'mild and moderate vulvovaginal candidiasis']","['clotrimazole vaginal expansion suppository and vaginal tablet', 'clotrimazole vaginal expansion suppository', 'clotrimazole vaginal tablet', 'clotrimazole']","['vaginal stimulation, itching and burning sensation', 'total effective rate', 'recurrence rates', 'cure rate', 'clinical symptoms and signs scores', 'efficacy, patient satisfaction, side effects, and recurrence rate', 'mild and moderate vulvovaginal candidiasis', 'recurrence rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}]",,0.0386629,"The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups ( χ 2 = 1.070,  P =0.586).  ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'Q P', 'Initials': 'QP', 'LastName': 'Liao', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking University First hospital, Beijing 100034, China.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'An', 'Affiliation': ""Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Zheng', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'Q Q', 'Initials': 'QQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing 102218, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200403-00293']
1533,33121997,Oxaliplatin-based adjuvant chemotherapy duration (3 versus 6 months) for high-risk stage II colon cancer: the randomized phase III ACHIEVE-2 trial.,"BACKGROUND


Oxaliplatin-based adjuvant chemotherapy may be associated with debilitating peripheral sensory neuropathy (PSN) in patients with high-risk stage II colon cancer. This open-label, multicenter, randomized phase III trial was conducted as a prospective pooled analysis to investigate the non-inferiority of 3 versus 6 months of adjuvant oxaliplatin-based chemotherapy.
PATIENTS AND METHODS


From 12 February 2014 to 31 January 2017, 525 Asian patients with high-risk stage II colon cancer were randomly assigned to 3- and 6-month treatment arms. The treatment consisted of either modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine combined with oxaliplatin (CAPOX). The primary end point was disease-free survival (DFS). The secondary end points were treatment compliance and safety.
RESULTS


Of the 525 randomized patients, 11 were not treated. Among the 514 participating patients (255 in the 3-month arm; 259 in the 6-month arm), 432 (84%) received CAPOX, and 184 (36%) presented with T4 as a high-risk factor for recurrence. The 3-year DFS rate was 88.2% in the 3-month arm and 87.9% in the 6-month arm [hazard ratio (HR), 1.12; 95% confidence interval (CI), 0.67-1.87]. With CAPOX, the 3-year DFS rate was 88.2% in the 3-month arm and 88.4% in the 6-month arm (HR, 1.13; 95% CI, 0.65-1.96). The discontinuation rate in the 3- and 6-month arms was 10% and 31% for mFOLFOX6 (P = 0.0193), and 15% and 35% for CAPOX (P < 0.0001), respectively. The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001).
CONCLUSIONS


Three months of combination therapy presented significantly less grade ≥2 PSN than the respective 6-month regimen. The shortened therapy duration did not affect the 3-year DFS rate, suggesting that a 3-month course of CAPOX can be an effective treatment option.
CLINICAL TRIAL INFORMATION


UMIN Clinical Trials Registry, UMIN000013036 and Japan Registry of Clinical Trials, jRCTs031180128.",2020,"The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001).
","['patients with high-risk colon cancer', '514 participating patients (255 in the 3-month arm; 259 in the 6-month arm), 432 (84%) received', 'High-Risk Stage II Colon Cancer', 'stage II disease', 'From February 12, 2014 to January 31, 2017, 525 Asian patients with high-risk stage II colon cancer']","['modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine combined with oxaliplatin (CAPOX', 'CAPOX', 'Oxaliplatin-Based Adjuvant Chemotherapy Duration', 'adjuvant oxaliplatin-based chemotherapy', 'Oxaliplatin-based adjuvantchemotherapy']","['disease-free survival (DFS', '3-year DFS rate', 'discontinuation rate', 'grade ≥2 PSN', 'treatment compliance and safety', 'incidence of grade ≥2 PSN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",525.0,0.106532,"The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Gastrointestinal Center, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Department of Gastrointestinal Cancer Center, Sano Hospital, Hyogo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gamoh', 'Affiliation': 'Department of Medical Oncology, Osaki Citizen Hospital, Miyagi, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shiomi', 'Affiliation': 'Division of Colon and Rectal Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Munemoto', 'Affiliation': 'Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rikiyama', 'Affiliation': 'Department of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ueki', 'Affiliation': 'Department of Surgery, Hamanomachi Hospital, Fukuoka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shinkai', 'Affiliation': 'Department of Surgery, Chigasaki Municipal Hospital, Kanagawa, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tanida', 'Affiliation': 'Department of Surgery, Japanese Red Cross Kochi Hospital, Kochi, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sunami', 'Affiliation': 'Department of Tumor Surgery, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. Electronic address: tyoshino@east.ncc.go.jp.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.480']
1534,33123653,Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial.,"Context


The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon's glucose-lowering properties can be leveraged in individuals with prediabetes.
Objective


The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes.
Design Setting Participants and Intervention


This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks.
Main Outcome Measures


Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT.
Results


From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL ( P  < .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG ( P  < .001) and of the 2-hour PG of the OGTT ( P  < .05). There were no serious adverse events in either study group.
Conclusions


In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon's effects on the rate of progression from prediabetes to T2D.",2020,"When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG ( P  < .001) and of the 2-hour PG of the OGTT ( P  < .05).","['adult individuals meeting any criteria for prediabetes to receive', 'individuals with prediabetes', 'prediabetes', 'Participants were enrolled and followed at 2 academic centers for 12 weeks', 'Individuals With Prediabetes']","['cinnamon supplementation', 'Cinnamon', 'placebo', 'cinnamon 500 mg or placebo']","['FPG and glucose tolerance', 'fasting plasma glucose (FPG', 'change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC', 'AUC PG', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0008802', 'cui_str': 'Cinnamomum verum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.503134,"When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG ( P  < .001) and of the 2-hour PG of the OGTT ( P  < .05).","[{'ForeName': 'Giulio R', 'Initials': 'GR', 'LastName': 'Romeo', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Junhee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, Dongdaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Mulla', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Noh', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Holden', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, US.'}, {'ForeName': 'Byung-Cheol', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, Dongdaemun-gu, Seoul, Republic of Korea.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa094']
1535,33126095,Can counter-advertising protect spectators of elite sport against the influence of unhealthy food and beverage sponsorship? A naturalistic trial.,"RATIONALE AND OBJECTIVE


Unhealthy, energy-dense nutrient-poor foods and beverages are heavily promoted through sport sponsorship. This naturalistic trial assessed whether exposing young adult spectators to various types of counter-advertising (CA) before watching an unhealthy food sponsored elite sporting event could diminish sponsorship effects and increase support for restrictions on sponsorship.
METHOD


Young adults (ages 18-29 years) who planned to watch the Australian Football League (AFL) Grand Final were recruited through an online panel and randomly assigned to one of four conditions: (A) control (neutral advertisement); (B) anti-industry CA (critiquing unhealthy food industry sponsorship of sport); (C) anti-product CA (critiquing the association of sports stars with unhealthy food); or (D) negative health effects CA (highlighting negative health consequences of unhealthy food consumption). Participants (N = 1316) completed a pre-test questionnaire and viewed their assigned CA online 1-3 days before watching the 2017 AFL Grand Final, which featured unhealthy food sponsorship.
RESULTS


Participants who reported watching the AFL Grand Final (n = 802) answered post-test measures within five days of the event. Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA. The anti-industry CA promoted less favourable attitudes to sponsor brands, the anti-product CA promoted reduced intentions to purchase the fast-food sponsor brand, and the negative health effects CA reduced preferences for fast food in general compared to the control condition.
CONCLUSIONS


Anti-industry CA may detract from favourable attitudes to unhealthy food sponsor brands and negative health effects CA may detract from intentions to consume fast food in the face of unhealthy food sponsorship exposure. Such interventions may require higher dosage levels than applied in the present study to bolster spectators' resistance to the surfeit of unhealthy food sport sponsorship.",2020,"Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA.","['Young adults (ages 18-29 years) who planned to watch the Australian Football League (AFL) Grand Final were recruited through an online panel and randomly assigned to one of four conditions: (A) control (neutral advertisement', 'Participants (N\xa0=\xa01316) completed a']","['pre-test questionnaire and viewed their assigned CA online 1-3 days before watching the 2017 AFL Grand Final, which featured unhealthy food sponsorship', 'counter-advertising (CA']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],,0.017522,"Results indicated that participants found the anti-industry CA more believable, attention-grabbing, reassuring and encouraging than the anti-product CA.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia; School of Psychology, Curtin University, Bentley, Western Australia, Australia. Electronic address: Helen.Dixon@cancervic.org.au.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Victoria, Australia; Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': 'Early Start, School of Health and Society, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'The George Institute for Global Health, Newtown, New South Wales, Australia; School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Chapman', 'Affiliation': 'School of Life and Environment Sciences, Faculty of Science, University of Sydney, Sydney, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia; Heart Foundation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Niederdeppe', 'Affiliation': 'Department of Communication, Cornell University, Ithaca, NY, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113415']
1536,33126096,Reducing HIV- and TB-Stigma among healthcare co-workers in South Africa: Results of a cluster randomised trial.,"RATIONALE


The HIV and TB co-epidemic has a severe impact on the South African healthcare workforce and health system. HIV- and TB- stigma directed from healthcare workers (HCWs) towards colleagues not only has a negative impact on the mental health and well-being of the HCWs, but has been identified as a barrier to their own health-seeking behaviour. It also increases the strain on the health system due to absenteeism.
OBJECTIVE


This cluster-randomised trial tested an intervention to reduce HIV- and TB-stigma among HCWs. The intervention, based on the theory of Diffusion of Innovations consisted of training healthcare workers as change agents in a Social and Behavioural Change Communication workshop to help them change stigmatising attitudes in the workplace. This was supported by a social marketing campaign.
METHODS


Eight hospitals in the Free State province were randomised into intervention and control group in a stratified study design. 652 respondents randomly drawn from the hospitals were surveyed on aspects of HIV and TB stigma once in 2016 and again in 2018. Since the study only used four hospitals per intervention arm, cluster-based summaries were compared when analysing the intervention effect, using the nonparametric Mann-Whitney test. To explore how the intervention worked, 24 qualitative focus groups were conducted following the intervention.
RESULTS


The quantitative test did not show a significant intervention effect on stigma between intervention and control groups. Qualitative evidence reported new awareness and changed behaviour related to HIV- and TB-stigma among individual HCWs, but a combination of factors including strong social hierarchies in the workplace and the down-scaling of the original version of the intervention seemed to reduce the impact. Conclusion The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.",2020,"The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.","['652 respondents randomly drawn from the hospitals were surveyed on aspects of HIV and TB stigma once in 2016 and again in 2018', 'healthcare co-workers in South Africa', 'Eight hospitals in the Free State province']",[],"['HIV and TB stigma', 'Reducing HIV- and TB-Stigma', 'HIV- and TB-stigma among HCWs']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",652.0,0.0411659,"The findings did not indicate a significant intervention effect, but show the potential of using HCWs as change agents to reduce HIV and TB stigma in their local communities.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sommerland', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium. Electronic address: nina.sommerland@gmail.com.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Masquillier', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Asta', 'Initials': 'A', 'LastName': 'Rau', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Engelbrecht', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Centre for Health Systems Research and Development, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'Centre for Evaluation, Department Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Janse van Rensburg', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Wouters', 'Affiliation': 'Centre for Population, Family and Health, Department of Sociology, University of Antwerp, Antwerp, Belgium.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113450']
1537,33127291,Respiratory muscle training in late-onset Pompe disease: Results of a sham-controlled clinical trial.,"To address progressive respiratory muscle weakness in late-onset Pompe disease (LOPD), we developed a 12-week respiratory muscle training (RMT) program. In this exploratory, double-blind, randomized control trial, 22 adults with LOPD were randomized to RMT or sham-RMT. The primary outcome was maximum inspiratory pressure (MIP). Secondary and exploratory outcomes included maximum expiratory pressure (MEP), peak cough flow, diaphragm ultrasound, polysomnography, patient-reported outcomes, and measures of gross motor function. MIP increased 7.6 cmH 2 O (15.9) in the treatment group and 2.7 cmH 2 O (7.6) in the control group (P = 0.4670). MEP increased 14.0 cmH 2 O (25.9) in the treatment group and 0.0 cmH 2 O (12.0) in the control group (P = 0.1854). The only statistically significant differences in secondary/exploratory outcomes were improvements in time to climb 4 steps (P = 0.0346) and daytime sleepiness (P = 0.0160). The magnitude of changes in MIP and MEP in the treatment group were consistent with our pilot findings but did not achieve statistical significance in comparison to controls. Explanations for this include inadequate power and baseline differences in subject characteristics between groups. Additionally, control group subjects appeared to exhibit an active response to sham-RMT and therefore sham-RMT may not be an optimal control condition for RMT in LOPD.",2020,The only statistically significant differences in secondary/exploratory outcomes were improvements in time to climb 4 steps (P = 0.0346) and daytime sleepiness (P = 0.0160).,"['late-onset Pompe disease (LOPD', 'late-onset Pompe disease', '22 adults with LOPD']","['Respiratory muscle training', 'respiratory muscle training (RMT) program', 'RMT or sham-RMT']","['daytime sleepiness', 'time to climb 4 steps', 'maximum inspiratory pressure (MIP', 'MEP', 'MIP and MEP', 'MIP', 'maximum expiratory pressure (MEP), peak cough flow, diaphragm ultrasound, polysomnography, patient-reported outcomes, and measures of gross motor function']","[{'cui': 'C0342753', 'cui_str': 'Glycogen storage disease due to acid maltase deficiency, late-onset'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}]",22.0,0.13199,The only statistically significant differences in secondary/exploratory outcomes were improvements in time to climb 4 steps (P = 0.0346) and daytime sleepiness (P = 0.0160).,"[{'ForeName': 'Harrison N', 'Initials': 'HN', 'LastName': 'Jones', 'Affiliation': 'Department of Head and Neck Surgery & Communication Sciences, Duke University School of Medicine, 155 Baker House, Trent Dr., DUMC 3887, Durham, NC 27710, USA; Division of Speech Pathology and Audiology, Duke University Medical Center, Durham, NC, USA. Electronic address: harrison.jones@duke.edu.'}, {'ForeName': 'Maragatha', 'Initials': 'M', 'LastName': 'Kuchibhatla', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Crisp', 'Affiliation': 'Department of Head and Neck Surgery & Communication Sciences, Duke University School of Medicine, 155 Baker House, Trent Dr., DUMC 3887, Durham, NC 27710, USA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Hobson-Webb', 'Affiliation': 'Department of Neurology, Neuromuscular Division, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Case', 'Affiliation': 'Division of Physical Therapy, Duke University School Of Medicine, Durham, NC, USA.'}, {'ForeName': 'Milisa T', 'Initials': 'MT', 'LastName': 'Batten', 'Affiliation': 'Division of Speech Pathology and Audiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marcus', 'Affiliation': 'Division of Speech Pathology and Audiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Kravitz', 'Affiliation': 'Division of Pediatric Pulmonary and Sleep Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Priya S', 'Initials': 'PS', 'LastName': 'Kishnani', 'Affiliation': 'Department of Pediatrics, Division of Medical Genetics, Duke University School of Medicine, Durham, NC, USA.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.09.023']
1538,33127414,"Reewarm™ PTX drug-coated balloon in the treatment of femoropopliteal artery disease: A multi-center, randomized controlled trial in China.","BACKGROUND


Drug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases.
OBJECTIVE


To evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon.
METHODS


This was a multi-center, parallel-group, randomized controlled trial in patients with femoropopliteal artery lesions in China,. The participants were randomized 1:1 to percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA group) after pre-dilatation with a residual stenosis less than 70%. The primary endpoint was late lumen loss (LLL) at 6 months in the intent-to-treat set. The secondary endpoints included the target lesion revascularization (TLR) and major advance events(MAE)rate at 12 months.
RESULTS


Between July 2014 and April 2017, a total of 200 patients were enrolled. The mean age of the subjects was 67.8 ± 9.2 years in the DCB group (n = 100) and 69.4 ± 10.3 years in the PTA group (n = 100). The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001). The TLR rate in the DCB group was lower than in the PTA group at 12 months (15.0% vs. 29.0%, P < 0.05). The occurrence of MAE 4  in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05).
CONCLUSION


Reewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion.",2020,"The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001).","['patients with femoropopliteal artery lesions in China', 'The mean age of the subjects was 67.8\u202f±\u202f9.2\u202fyears in the DCB group (n\u202f=\u202f100) and 69.4\u202f±\u202f10.3\u202fyears in the PTA group (n\u202f=\u202f100', 'Between July 2014 and April 2017, a total of 200 patients were enrolled']","['plain balloon', 'Reewarm™ PTX drug-coated balloon', 'percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA', 'Drug-coated balloons (DCB', 'Reewarm™ PTX DCB']","['efficacy and safety', 'target lesion revascularization (TLR) and major advance events(MAE)rate at 12\u202fmonths', 'late lumen loss (LLL', 'TLR rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",200.0,0.0611449,"The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ye', 'Affiliation': 'Department of Vascular Surgery, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular Surgery, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiangchen', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'Department of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of vascular surgery, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhaoyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': ""Mi'er"", 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': ""Department of Vascular Surgery, Shanghai the Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Changwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Chinese Academy of Medical Science, Peking Union Medical College Hospital, Beijing, China. Electronic address: liucw@vip.sina.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.10.060']
1539,33128801,"Dexmedetomidine versus clonidine adjuvants to levobupivacaine for ultrasound-guided transversus abdominis plane block in paediatric laparoscopic orchiopexy: Randomized, double-blind study.","BACKGROUND


Laparoscopic surgeries are associated with less postoperative pain and adverse events compared to open procedures. But, it still reduces the quality of life in children. Transversus abdominis plane (TAP) block is used to reduce pain. We hypothesized that dexmedetomidine or clonidine could improve the analgesic profile of levobupivacaine to the same extent during TAP block in children.
METHODS


Ninety children were randomly allocated in a randomized double-blind trial to receive bilateral TAP block with levobupivacaine plus normal saline (group B, n = 30), or dexmedetomidine (group D, n = 30) or clonidine (group C, n = 30). Primary outcome was the modified Children's Hospital of Eastern Ontario Pain Scale score. Secondary outcomes included time to initial analgesic request, number of analgesic claims, total analgesic consumption, parents' satisfaction, sedation score and complications.
RESULTS


Children of group D showed reduced pain scores compared to other groups. They represented the longest period of analgesia (565.00 ± 71.5 min) with p < 0.001, and fewer patients required two doses of analgesia during the first postoperative day. The cumulative amount of backup analgesia was significantly different between these groups (p = 0.026). Higher parents' satisfaction scores were recorded in groups D and C compared to group B. Sedation among the study groups revealed significant differences (p = 0.035), but no severe complications were recorded.
CONCLUSIONS


Adding dexmedetomidine to levobupivacaine can extend the time of analgesia and reduce the use of postoperative backup analgesics with minimal sedation effects when used in TAP block in paediatrics undergoing laparoscopic orchiopexy. Clonidine can be used as an alternative adjuvant to local anaesthetics with good postoperative analgesic profiles.
SIGNIFICANCE


Clonidine can alternate dexmedetomidine during TAP block with local anesthetics for pediatrics laparoscopies. Both can lead to better postoperative analgesic profiles. Clonidine may be preferred, especially in our developing regions, because of its easy availability and lower cost than that of dexmedetomidine.",2020,"Higher parents' satisfaction scores were recorded in groups D and C compared to group-B. Sedation among the study groups revealed significant differences (p-value = 0.035), but no severe complications were recorded.
","['Pediatric Laparoscopic Orchiopexy', 'Ninety children', 'children', 'pediatrics undergoing laparoscopic orchiopexy']","['Levobupivacaine', 'Clonidine', 'bilateral TAP block with levobupivacaine plus normal saline', 'Dexmedetomidine', 'levobupivacaine', 'dexmedetomidine', 'Transversus abdominis plane (TAP) block', 'clonidine']","['modified CHEOPS score', 'analgesic profile', 'cumulative amount of backup analgesia', 'postoperative pain and adverse events', ""Higher parents' satisfaction scores"", 'reduced pain scores', 'severe complications', ""time to initial analgesic request, number of analgesic claims, total analgesic consumption, parents' satisfaction, sedation score, and complications"", 'quality of life']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2717780', 'cui_str': 'Laparoscopic Orchiopexy'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.498786,"Higher parents' satisfaction scores were recorded in groups D and C compared to group-B. Sedation among the study groups revealed significant differences (p-value = 0.035), but no severe complications were recorded.
","[{'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Esam', 'Initials': 'E', 'LastName': 'Hamed', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed H', 'Initials': 'AH', 'LastName': 'Amin', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1689']
1540,33129442,"Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial.","BACKGROUND


The safety and efficacy of ocrelizumab in primary progressive multiple sclerosis were shown in the phase 3 ORATORIO trial. In this study, we assessed the effects of maintaining or switching to ocrelizumab therapy on measures of disease progression and safety in the open-label extension phase of ORATORIO.
METHODS


ORATORIO was an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done at 182 study locations including academic centres, hospitals, and community speciality centres within 29 countries across the Americas, Australia, Europe, Israel, New Zealand, and Russia. Patients with primary progressive multiple sclerosis aged 18-55 years who had an Expanded Disability Status Scale (EDSS) score of 3·0-6·5 were eligible for enrolment. Those who had previous treatment with B-cell-targeted therapies or other immunosuppressive medications were excluded. Eligible participants were randomly assigned (2:1) to receive either intravenous infusion of 600 mg of ocrelizumab (two 300 mg infusions 14 days apart) or placebo every 24 weeks for at least 120 weeks until a prespecified number (n=253) of disability events occurred. After the double-blind phase, patients entered an extended controlled period of variable duration, during which they and investigators became aware of treatment allocation. Following this period, patients could enter an optional open-label extension, during which they continued ocrelizumab or switched from placebo to ocrelizumab. Time to onset of disability progression was confirmed at 24 weeks with four measures (ie, increase in EDSS score, ≥20% increase in time to complete the 9-Hole Peg Test [9HPT], ≥20% increase in time to perform the Timed 25-Foot Walk [T25FW], and composite progression defined as the first confirmed occurrence of any of these three individual measures), as was time to requiring a wheelchair (EDSS ≥7). Conventional MRI measures were also analysed. The intention-to-treat population was used for the safety and efficacy analyses; all analyses, and their timings, were done post hoc. ORATORIO is registered with ClinicalTrials.gov, NCT01194570, and is ongoing.
FINDINGS


From March 3, 2011, to Dec 27, 2012, 488 patients were randomly assigned to the ocrelizumab group and 244 to the placebo group. The extended controlled period started on July 24, 2015, and ended on April 27, 2016, when the last patient entered the open-label extension. Overall, 544 (74%) of 732 participants completed the double-blind period to week 144; 527 (97%) of 544 entered the open-label extension phase, of whom 451 (86%) are ongoing in the open-label extension. After at least 6·5 study years (48 weeks per study year) of follow-up, the proportion of patients with progression on disability measures was lower in those who initiated ocrelizumab early than in those initially receiving placebo for most of the measures of 24-week confirmed disability progression: EDSS, 51·7% vs 64·8% (difference 13·1% [95% CI 4·9-21·3]; p=0·0018); 9HPT, 30·6% vs 43·1% (12·5% [4·1-20·9]); p=0·0035); T25FW, 63·2% vs 70·7% (7·5% [-0·3 to 15·2]; p=0·058); composite progression, 73·2% vs 83·3% (10·1% [3·6-16·6]; p=0·0023); and confirmed time to requiring a wheelchair, 11·5% vs 18·9% (7·4% [0·8-13·9]; p=0·0274). At study end, the percentage change from baseline was lower in those who initiated ocrelizumab early than in those initially receiving placebo for T2 lesion volume (0·45% vs 13·00%, p<0·0001) and T1 hypointense lesion volume (36·68% vs 60·93%, p<0·0001). Over the entire period, in the ORATORIO all ocrelizumab exposure population, the rate of adverse events was 238·09 (95% CI 232·71-243·57) per 100 patient-years and serious adverse events was 12·63 (95% CI 11·41-13·94) per 100 patient-years; the most common serious adverse events were infections at 4·13 (95% CI 3·45-4·91) per 100 patient-years. No new safety signals emerged compared with the double-blind phase of ORATORIO.
INTERPRETATION


Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up. Although this study shows the benefit of earlier intervention with ocrelizumab in primary progressive disease, progression remains an important unmet need in multiple sclerosis. Further research should focus on how the potential benefits described in this study might be improved upon, particularly over longer time periods.
FUNDING


F Hoffmann-La Roche.",2020,"Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up.","['732 participants completed the double-blind period to week 144; 527 (97%) of 544 entered the open-label extension phase, of whom 451 (86%) are ongoing in the open-label extension', '182 study locations including academic centres, hospitals, and community speciality centres within 29 countries across the Americas, Australia, Europe, Israel, New Zealand, and Russia', 'From March 3, 2011, to Dec 27, 2012, 488 patients', 'primary progressive multiple sclerosis', 'Eligible participants', 'Patients with primary progressive multiple sclerosis aged 18-55 years who had an Expanded Disability Status Scale (EDSS) score of 3·0-6·5 were eligible for enrolment', 'Those who had previous treatment with B-cell-targeted therapies or other immunosuppressive medications were excluded']","['intravenous infusion of 600 mg of ocrelizumab', 'ocrelizumab', 'maintaining or switching to ocrelizumab therapy', 'ocrelizumab or switched from placebo to ocrelizumab', 'placebo']","['proportion of patients with progression on disability measures', 'EDSS score', 'time to requiring a wheelchair (EDSS ≥7', 'disease progression', 'disease progression and safety', 'T1 hypointense lesion volume', 'time to perform the Timed 25-Foot Walk', 'rate of adverse events', 'Time to onset of disability progression', 'Conventional MRI measures', 'time to complete the 9-Hole Peg Test [9HPT', 'serious adverse events']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",488.0,0.35322,"Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up.","[{'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: jerry.s.wolinsky@uth.tmc.edu.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Department of Neurology and Neurosurgery, Faculty of Medicine, McGill University, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Department of Neurology, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Universitätsklinikum Düsseldorf, Center of Neurology and Neuropsychiatry, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Neurology-Neuroimmunology Department and Neurorehabilitation Unit, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Overell', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Sauter', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Bennett', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Hubeaux', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30342-2']
1541,33132112,Effect of health-promoting messages in television food commercials on adolescents' attitudes and consumption: A randomized intervention study.,"INTRODUCTION


The HAVISA plan is a Spanish government's policy for the promotion of healthy lifestyles via health messages in television food advertisements. This study evaluated the positive or negative impact (health halo effect) of health messages on food choices and predisposition towards healthy habits of Spanish adolescents.
METHODS


Randomized controlled study in 11-14 years old adolescents. The intervention group watched television advertisements for unhealthy foods with HAVISA health messages, while the control group watched the same advertisements without them. A self-administered questionnaire measured participants' attitudes towards the products advertised, to diet and physical activity, and recognition of messages. Afterwards they chose between fruit and unhealthy snacks. The differences between the two groups were then compared.
RESULTS


A total of 27.2% of the control group versus 29.6% of the intervention group chose fruit (p = 0.54). Both groups displayed high desire for (7.24 vs. 7.40, p = 0.29) and intention to consume (6.67 vs. 6.73, p = 0.63) the unhealthy products advertised. There were no differences in perceived healthiness of these foods (4.11 vs. 4.19, p = 0.74), or perceived importance of a healthy diet (3.17 vs. 3.12, p = 0.55) or physical activity (4.53 vs. 4.51, p = 0.73). Desire for vegetables (2.49 vs. 2.66, p = 0.08) and fruit (3.15 vs. 3.30, p = 0.09) were higher in the intervention group, but the differences were not significant. Only 47.6% of participants noticed the presence of health messages; of these, 31% correctly recalled their content.
CONCLUSION


HAVISA health messages changed neither the attitudes nor immediate eating behaviors of adolescents. There was no immediate healthy-lifestyle promoter or adverse health halo effect, probably due to the messages' low prominence. Further research should evaluate the long-term effect of repeated exposure to health messages.",2020,"Desire for vegetables (2.49 vs. 2.66, p = 0.08) and fruit (3.15 vs. 3.30, p = 0.09) were higher in the intervention group, but the differences were not significant.","['11-14 years old adolescents', ""adolescents' attitudes and consumption"", 'healthy habits of Spanish adolescents']","['health messages', 'intervention group watched television advertisements for unhealthy foods with HAVISA health messages, while the control group watched the same advertisements without them', 'health-promoting messages']","['Desire for vegetables', 'presence of health messages', 'physical activity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0628519,"Desire for vegetables (2.49 vs. 2.66, p = 0.08) and fruit (3.15 vs. 3.30, p = 0.09) were higher in the intervention group, but the differences were not significant.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández-Escobar', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: carlos.fe.es@gmail.com.'}, {'ForeName': 'Doris Xiomara', 'Initials': 'DX', 'LastName': 'Monroy-Parada', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: doxiomonpa1@gmail.com.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ordaz Castillo', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: eordaz@isciii.es.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lois', 'Affiliation': 'Social Psychology Department, Universidad Nacional de Educación a Distancia, Calle de Juan Del Rosal, 10, 28040, Madrid, Spain. Electronic address: davidlois@psi.uned.es.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Royo-Bordonada', 'Affiliation': 'Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Calle Sinesio Delgado 10, 28029, Madrid, Spain. Electronic address: mroyo@isciii.es.'}]",Appetite,['10.1016/j.appet.2020.105014']
1542,33132156,Characterization of retinal microvasculature and its relations to cognitive function in older people after circuit resistance training.,"PURPOSE


To characterize the changes of retinal microvascular density and their relations to cognitive function in the healthy older people without known cognitive impairment after an 8-week high-speed circuit resistance training program (HSCT).
METHODS


Twenty cognitively normal older people were recruited and randomly assigned to either the HSCT group or control group (CON). Twelve subjects (age 70.8 ± 5.8 yrs) in the HSCT group trained three times per week for 8 weeks. Eight subjects in the CON group (age 71.8 ± 4.8 yrs) did not perform formal training. Both eyes of each subject were imaged using optical coherence tomography angiography (OCTA) at baseline and at 8-week follow-up. The densities of the retinal vascular network (RVN), superficial vascular plexus (SVP), and deep vascular plexus (DVP) were measured. In addition, their cognitive functions were tested using the NIH toolbox.
RESULTS


There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group. Although the vessel densities did not differ between visits in either group, the variation (i.e., change) in retinal vessel density of SVP was negatively related to the changes of FCS (r = -0.54, P = 0.007) and the List Sorting Working Memory test (r = -0.43, P = 0.039) in the HSCT group.
CONCLUSIONS


This is the first study to reveal that the individual response of the SVD was related to the improvement in the cognition in cognitively normal older people after HSCT.",2020,"There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group.","['Eight subjects in the CON group (age 71.8\xa0±\xa04.8\xa0yrs) did not perform formal training', 'healthy older people without known cognitive impairment after an 8-week high', 'cognitively normal older people after HSCT', 'Twenty cognitively normal older people', 'Twelve subjects (age 70.8\xa0±\xa05.8\xa0yrs) in the', 'older people after circuit resistance training']","['optical coherence tomography angiography (OCTA', 'HSCT group or control group (CON', 'speed circuit resistance training program (HSCT', 'HSCT']","['List Sorting Working Memory test', 'vessel densities', 'pattern comparison processing speed (PAT, P\xa0=\xa00.02) and fluid composite score', 'retinal vessel density of SVP', 'densities of the retinal vascular network (RVN), superficial vascular plexus (SVP), and deep vascular plexus (DVP']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517796', 'cui_str': '5.8'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035330', 'cui_str': 'Structure of blood vessel of retina'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",20.0,0.0222647,"There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Shenzhen Key Laboratory of Ophthalmology, Shenzhen Eye Hospital, Jinan University, Shenzhen, China; Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Totillo', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: hjiang@med.miami.edu.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Experimental gerontology,['10.1016/j.exger.2020.111114']
1543,33146457,"No effects of dapagliflozin, metformin or exercise on plasma glucagon concentrations in individuals with prediabetes: A post hoc analysis from the randomized controlled PRE-D trial.","AIM


To assess the effects of dapagliflozin, metformin and exercise treatment on changes in plasma glucagon concentrations in individuals with overweight and HbA1c-defined prediabetes.
MATERIALS AND METHODS


One-hundred and twenty individuals with overweight (body mass index ≥ 25 kg/m 2  ) and prediabetes (HbA1c of 39-47 mmol/mol) were randomized to a 13-week intervention with dapagliflozin (10 mg once daily), metformin (850 mg twice daily), exercise (30 minutes of interval training 5 days per week) or control (habitual living). A 75-g oral glucose tolerance test (OGTT) (0, 30, 60 and 120 minutes) was administered at baseline, at 13 weeks (end of intervention) and at 26 weeks (end of follow-up). Linear mixed effects models with participant-specific random intercepts were used to investigate associations of the interventions with fasting plasma glucagon concentration, insulin/glucagon ratio and glucagon suppression during the OGTT.
RESULTS


At baseline, the median (Q1; Q3) age was 62 (54; 68) years, median fasting plasma glucagon concentration was 11 (7; 15) pmol/L, mean (SD) HbA1c was 40.9 (2.3) mmol/mol and 56% were women. Compared with the control group, fasting glucagon did not change in any of the groups from baseline to the end of the intervention (dapagliflozin group: -5% [95% CI: -29; 26]; exercise group: -8% [95% CI: -31; 24]; metformin group: -2% [95% CI: -27; 30]). Likewise, there were no differences in insulin/glucagon ratio and glucagon suppression during the OGTT between the groups.
CONCLUSIONS


In individuals with prediabetes, 13 weeks of treatment with dapagliflozin, metformin or exercise was not associated with changes in fasting or post-OGTT glucagon concentrations.",2020,Compared with the control group fasting glucagon did not change in any of the groups from baseline to end of intervention (dapagliflozin group: -5% (95%CI:-29;26); exercise group: -8% (95%CI:-31;24); metformin group: -2% (95%CI:-27;30)).,"['individuals with prediabetes', '120 individuals with overweight', 'individuals with overweight and HbA 1c  -defined prediabetes']","['metformin', 'dapagliflozin, metformin and exercise treatment', 'exercise (interval training 30 min, 5\u2009days/week) or control (habitual living', 'dapagliflozin, metformin or exercise', 'dapagliflozin']","['fasting plasma glucagon concentration, insulin/glucagon ratio and glucagon suppression', 'insulin/glucagon ratio and glucagon suppression', 'changes in fasting or post-OGTT glucagon concentrations', 'fasting glucagon', 'plasma glucagon concentrations', 'median fasting plasma glucagon concentration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",120.0,0.0508403,Compared with the control group fasting glucagon did not change in any of the groups from baseline to end of intervention (dapagliflozin group: -5% (95%CI:-29;26); exercise group: -8% (95%CI:-31;24); metformin group: -2% (95%CI:-27;30)).,"[{'ForeName': 'Kim K B', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Amadid', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Bruhn', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'NNF Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe S', 'Initials': 'SS', 'LastName': 'Torekov', 'Affiliation': 'NNF Center for Basic Metabolic Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas S', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Faerch', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14246']
1544,31745223,Tensor decomposition of TMS-induced EEG oscillations reveals data-driven profiles of antiepileptic drug effects.,"Transcranial magnetic stimulation combined with electroencephalography is a powerful tool to probe human cortical excitability. The EEG response to TMS stimulation is altered by drugs active in the brain, with characteristic ""fingerprints"" obtained for drugs of known mechanisms of action. However, the extraction of specific features related to drug effects is not always straightforward as the complex TMS-EEG induced response profile is multi-dimensional. Analytical approaches can rely on a-priori assumptions within each dimension or on the implementation of cluster-based permutations which do not require preselection of specific limits but may be problematic when several experimental conditions are tested. We here propose an alternative data-driven approach based on PARAFAC tensor decomposition, which provides a parsimonious description of the main profiles underlying the multidimensional data. We validated reliability of PARAFAC on TMS-induced oscillations before extracting the features of two common anti-epileptic drugs (levetiracetam and lamotrigine) in an integrated manner. PARAFAC revealed an effect of both drugs, significantly suppressing oscillations in the alpha range in the occipital region. Further, this effect was stronger under the intake of levetiracetam. This study demonstrates, for the first time, that PARAFAC can easily disentangle the effects of subject, drug condition, frequency, time and space in TMS-induced oscillations.",2019,"The EEG response to TMS stimulation is altered by drugs active in the brain, with characteristic ""fingerprints"" obtained for drugs of known mechanisms of action.",[],"['Transcranial magnetic stimulation combined with electroencephalography', 'levetiracetam', 'levetiracetam and lamotrigine', 'PARAFAC']",[],[],"[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.02392,"The EEG response to TMS stimulation is altered by drugs active in the brain, with characteristic ""fingerprints"" obtained for drugs of known mechanisms of action.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tangwiriyasakul', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK. chayanin.tangwiriyasakul@kcl.ac.uk.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Premoli', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spyrou', 'Affiliation': 'School of Engineering, Institute for Digital Communications, The University of Edinburgh, Thomas Bayes Rd, Edinburgh, EH9 3FG, UK.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Chin', 'Affiliation': 'Muir Maxwell Epilepsy Centre, Centre for Clinical Brain Sciences and MRC Centre for Reproductive Health, The University of Edinburgh, 20 Sylvan Place, Edinburgh, EH9 1UW, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Escudero', 'Affiliation': 'School of Engineering, Institute for Digital Communications, The University of Edinburgh, Thomas Bayes Rd, Edinburgh, EH9 3FG, UK.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Richardson', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, London, UK.""}]",Scientific reports,['10.1038/s41598-019-53565-9']
1545,33151374,Acute rewarding and disinhibiting effects of alcohol as indicators of drinking habits.,"RATIONALE


Laboratory studies have reliably shown that heightened sensitivity to the rewarding effects of alcohol is associated with heavier drinking patterns. More recently, there has been research to suggest that heightened sensitivity to the disinhibiting effects of alcohol might also contribute to drinking habits. Most research on the acute effects of alcohol has focused on drinking magnitudes averaged across participants with little attention paid to how individual differences influence alcohol abuse potential. In large part, this is due to limited sample sizes in previous laboratory studies.
OBJECTIVES


This study overcomes previous limitations by testing the degree to which individual differences in acute sensitivity and tolerance to the rewarding and disinhibiting effects of alcohol relate to drinking behavior in a large sample size.
METHODS


Data from six laboratory studies were aggregated to comprise a sample of 181 adults. Participants' level of ""liking"" (the effects of alcohol) and disinhibition were assessed following 0.65 g/kg alcohol once during the ascending limb of the blood alcohol concentration (BAC) curve and again at the same BAC during the descending limb of the curve. The measures were also assessed following placebo.
RESULTS


Alcohol increased ratings of liking and behavioral disinhibition. Heavier drinking was associated with heightened sensitivity to liking on the ascending limb. Additionally, those who showed reduced acute tolerance to both disinhibition and liking were also heavier drinkers.
CONCLUSIONS


These data suggest that individual variability in liking the effects of alcohol and persistent disinhibition are key indicators of drinking habits.",2020,"RESULTS


Alcohol increased ratings of liking and behavioral disinhibition.",['Data from six laboratory studies were aggregated to comprise a sample of 181 adults'],[],"['ratings of liking and behavioral disinhibition', 'liking', 'blood alcohol concentration (BAC) curve', 'acute tolerance']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",181.0,0.0201374,"RESULTS


Alcohol increased ratings of liking and behavioral disinhibition.","[{'ForeName': 'Holley C', 'Initials': 'HC', 'LastName': 'Allen', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Wesley', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fillmore', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, 40506-0044, USA. fillmore@uky.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05667-w']
1546,33147353,Combined short- and long-axis method for internal jugular vein catheterization in premature newborns: A randomized controlled trial.,"BACKGROUND


Rapid central venous catheterization is critical for the rescue and perioperative management of premature infants requiring surgery. Ultrasound-guided dynamic needle tip positioning (DNTP) has been widely used as a very effective technique, especially in paediatric vascular puncture and catheterization. However, for low-weight premature newborns, central vein catheterization still poses greater difficulties for paediatricians and paediatric anaesthesiologists. This prospective randomized control study aimed to evaluate the efficacy of combined short- and long-axis (CSLA) internal jugular vein catheterization for premature newborns in comparison with the DNTP technique.
METHODS


A total of 90 premature newborns (gestational age < 37 weeks and < 28 days after birth) who were scheduled for surgery were included in this study. All enrolled premature newborns were randomly divided into two groups (n = 45): the CSLA group and the DNTP group. We compared the first-puncture success rate, total success rate, procedure time, number of needle passes, occurrence of complications and other outcome measures between the two groups.
RESULTS


The two groups (n = 45 per group) were similar in sex, gestational age, weight, mean arterial blood pressure, and vein-related measurements of the internal jugular vein. Total success was achieved in 43 (95.6%) and 36 (80.0%) patients in the CSLA and DNTP groups respectively. Compared with the DNTP group, the CSLA group showed a significantly higher first-attempt success rate (71.1% vs 46.7%, χ 2   = 5.5533, P = .0184) and significantly fewer needle passes (1.0[1.0-2.0] vs 2.0[1.0-3.0], χ 2   = -2.6094, P = .0091). There was no significant difference between the groups in the procedure time (368[304-573] vs 478[324-79]s, Z = -1.7690, P = .0769). Complications occurred in both groups, but the incidence was significantly lower in the CSLA group than in the DNTP group (6.7% vs 22.2%, χ 2   = 4.4056, P = .0358).
CONCLUSIONS


Ultrasound-guided internal jugular vein catheterization by the CSLA method is effective and safe. The CSLA method may be superior to the DNTP technique in premature newborns.",2020,"Complications occurred in both groups, but the incidence was significantly lower in the CSLA group than in the DNTP group (6.7% vs. 22.2%, χ2 =4.4056, P=0.0358).
","['90 premature newborns (gestational age <37 weeks and <28 d after birth) who were scheduled for surgery were included in this study', 'premature newborns in comparison with the DNTP technique', 'All enrolled premature newborns', 'premature infants requiring surgery', 'premature newborns']","['combined short- and long-axis (CSLA) internal jugular vein catheterization', 'Combined short- and long-axis method for internal jugular vein catheterization', 'CSLA', 'DNTP', 'Ultrasound-guided dynamic needle tip positioning (DNTP', 'CSLA group and the DNTP']","['procedure time', 'higher first-attempt success rate', 'Complications', 'puncture success rate, total success rate, procedure time, number of needle passes, occurrence of complications', 'Total success', 'needle passes']","[{'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0522487', 'cui_str': 'Long axis'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",90.0,0.0343837,"Complications occurred in both groups, but the incidence was significantly lower in the CSLA group than in the DNTP group (6.7% vs. 22.2%, χ2 =4.4056, P=0.0358).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Tu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Lifei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Yanzhe', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': ""Department of Anesthesiology, Children's Hospital of Chongqing Medical University, Chongqing, China.""}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13728']
1547,33147492,Outcome of Laparoscopic Adhesiolysis in Infertile Patients with Pelvic Adhesions Following Cesarean Delivery: A Randomized Clinical Trial.,"OBJECTIVES


To evaluate results of laparoscopic adhesiolysis in patients with post cesarean infertility regards restoration of the fertility and achievement of pregnancy. To identify a group of patients who should primarily be offered laparoscopic adhesiolysis and those who should be treated by IVF.
DESIGN


Randomized prospective clinical trial MATERIALS AND METHODS: 184 patients with secondary infertility diagnosed to have periadnexal and pelvic adhesions, were randomly allocated into two groups: group I (92 cases) treated by laparoscopic adhesiolysis and group II (92 cases) who treated for a year by controlled ovarian stimulation and IUI up to 3 trials. Diagnostic work-up of infertility was carried out denoting normal semen, patent both tubes at HSG, and ovulatory at ovulation testing with normal hormonal profile. The outcomes, cumulative pregnancy rates calculated for each group after one year.
RESULTS


According to the adhesions, the patients classified into 4 groups: 8 cases inoperable, 43 cases with mild type adhesions, 26 cases with moderate type adhesions, and 5 cases with severe type adhesions. The patients followed up postoperatively for year. Overall pregnancy rate 54.35 %. For patients with mild adhesions 76.7%, for patients with moderate adhesions 61.5%, and for patients with severe adhesions 20%. Complications present in (1.57%), cost is (125.7-180.9 $). Over all pregnancy rate was 11.96% in group (II) CONCLUSIONS: laparoscopic adhesiolysis is the method of choice for dealing with mild to moderate periadnexal adhesions after C.S. The pregnancy outcome after lysis of severe periadnexal adhesions is poor. So, such patients are best treated by IVF.",2020,Over all pregnancy rate was 11.96% in group (II) CONCLUSIONS: laparoscopic adhesiolysis is the method of choice for dealing with mild to moderate periadnexal adhesions after C.S.,"['patients with post cesarean infertility regards restoration of the fertility and achievement of pregnancy', '43 cases with mild type adhesions, 26 cases with moderate type adhesions, and 5 cases with severe type adhesions', '184 patients with secondary infertility diagnosed to have periadnexal and pelvic adhesions', 'patients who should primarily be offered laparoscopic adhesiolysis and those who should be treated by IVF', 'Infertile Patients with Pelvic Adhesions Following Cesarean Delivery']","['Laparoscopic Adhesiolysis', 'laparoscopic adhesiolysis']","['pregnancy rate', 'cumulative pregnancy rates', 'Overall pregnancy rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0269230', 'cui_str': 'Secondary female infertility'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262591', 'cui_str': 'Pelvic adhesions'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0198539', 'cui_str': 'Laparoscopic lysis of adhesions'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0198539', 'cui_str': 'Laparoscopic lysis of adhesions'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",184.0,0.0753657,Over all pregnancy rate was 11.96% in group (II) CONCLUSIONS: laparoscopic adhesiolysis is the method of choice for dealing with mild to moderate periadnexal adhesions after C.S.,"[{'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'E Elgergawy', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt. Electronic address: dradelali775@gmai.com.'}, {'ForeName': 'Ahmed E', 'Initials': 'AE', 'LastName': 'Elhalwagy', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'A Salem', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Ayman S', 'Initials': 'AS', 'LastName': 'Dawood', 'Affiliation': 'Faculty of Medicine, Tanta University, Egypt.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101969']
1548,33147541,The effects of nano-curcumin supplementation on Th1/Th17 balance in migraine patients: A randomized controlled clinical trial.,"BACKGROUND


The present study was aimed to evaluate the nano-curcumin supplementation on Th1/Th17 balance by assessment of gene expression and serum level of interferon gamma (IFN-γ) and interleukin-17 (IL-17) in migraine patients.
METHODS


Forty participants with episodic migraine were randomly allocated to receive 80 mg nano-curcumin (n = 20) or placebo (n = 20) in a randomized double-blind clinical trial for two months. The expression of IFN-γ and IL-17 from peripheral blood mononuclear cells and IFN-γ and IL-17 serum levels were measured, using a real-time PCR and ELISA methods, respectively.
RESULTS


Compared to placebo group, two month nano-curcumin supplementation led to a significant reduction in serum levels and expression of IL-17 mRNA (P = 0.006 & 0.04, respectively), while there was no statistical difference regarding serum levels and expression of IFN-γ mRNA.
CONCLUSION


Nano-curcumin supplementation in migraine patients led to a significant reduction in gene expression and plasma levels of IL-17 compared to control group.",2020,"Compared to placebo group, two month nano-curcumin supplementation led to a significant reduction in serum levels and expression of IL-17 mRNA (P = 0.006 & 0.04, respectively), while there was no statistical difference regarding serum levels and expression of IFN-γ mRNA.
","['Forty participants with episodic migraine', 'migraine patients']","['80\xa0mg nano-curcumin', 'nano-curcumin supplementation', 'placebo']","['gene expression and serum level of interferon gamma (IFN-γ) and interleukin-17 (IL-17', 'expression of IFN-γ and IL-17 from peripheral blood mononuclear cells and IFN-γ and IL-17 serum levels', 'gene expression and plasma levels of IL-17', 'Th1/Th17 balance', 'serum levels and expression of IFN-γ mRNA', 'serum levels and expression of IL-17 mRNA']","[{'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",40.0,0.297115,"Compared to placebo group, two month nano-curcumin supplementation led to a significant reduction in serum levels and expression of IL-17 mRNA (P = 0.006 & 0.04, respectively), while there was no statistical difference regarding serum levels and expression of IFN-γ mRNA.
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Abdolahi', 'Affiliation': 'Amir Alam Hospital Complexes, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hosseini', 'Affiliation': 'Department of Immunology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Miraghajani', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; The Early Life Research Unit, Academic Division of Child Health, Obstetrics and Gynaecology, And Nottingham Digestive Disease Centre and Biomedical Research Centre, The School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mjalali87@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101256']
1549,33128790,Improvement of oral hypofunction by a comprehensive oral and physical exercise programme including textured lunch gatherings.,"The deterioration of oral function to a state of oral hypofunction (OHF) is reportedly associated with malnutrition and frailty. Thus, we Investigated the association of OHF with physical characteristics and function and test the effects of a programme including comprehensive oral and physical exercises and textured lunch gatherings (COPE-TeL programme) on oral and physical function in older adults with OHF. Eighty-six community-dwelling older adults were randomly assigned into control (n = 43) or intervention (n = 43) groups. The participants were further divided into OHF and normal oral function (NOF) sub-groups based on initial oral examinations. The intervention group participated in the 12-week COPE-TeL programme, while the control group performed the physical exercise regimen only. The differences in measured variables for physical and oral function between the OHF and NOF groups were statistically tested, and changes in the proportion of participants with OHF were examined. Physical function, such as hand grip strength and walking speed, was significantly lower in the OHF group at the initial assessment. The proportion of participants with OHF was 56% in the intervention group and 67% in the control group before the trial, which became significantly reduced after completing the COPE-TeL programme in the intervention group (26%, P = .002), but not in the controls (61%, P = .549). Older adults with OHF may have diminished physical function. The COPE-TeL programme of oral and physical exercises along with textured lunch gatherings may be effective for older adults with OHF.",2020,"RESULTS


Physical function, such as hand grip strength and walking speed, was significantly lower in the OHF group at the initial assessment.","['older adults with OHF', 'Eighty-six community-dwelling older adults', 'textured lunch gatherings', 'Older adults with OHF']","['comprehensive oral and physical exercises and textured lunch gatherings (COPE-TeL program', 'comprehensive oral and physical exercise program', 'OHF and normal oral function (NOF) sub-groups based on initial oral examinations', 'oral hypofunction (OHF', 'COPE-TeL program, while the control group performed the physical exercise regimen only']","['proportion of participants with OHF', 'physical and oral function', 'hand grip strength and walking speed']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0039466', 'cui_str': 'Telugu language'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204128', 'cui_str': 'Initial oral examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",86.0,0.0164072,"RESULTS


Physical function, such as hand grip strength and walking speed, was significantly lower in the OHF group at the initial assessment.","[{'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Department of Dentistry and Oral-Maxillofacial Surgery, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Norie', 'Initials': 'N', 'LastName': 'Kito', 'Affiliation': 'Department of Dentistry and Oral-Maxillofacial Surgery, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Food Care Co., Ltd., Sagamihara, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Izumi', 'Affiliation': 'Food Care Co., Ltd., Sagamihara, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Kishima', 'Affiliation': 'Department of Dentistry, Wakakusa Tatsuma Rehabilitation Hospital, Daito, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Itoda', 'Affiliation': 'Department of Oral Health Sciences, Osaka Dental University Faculty of Health Sciences, Osaka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': 'Division of Oral and Maxillofacial Biology, Institute for Oral Science, Matsumoto Dental University, Shiojiri, Japan.'}]",Journal of oral rehabilitation,['10.1111/joor.13122']
1550,33129157,Long-term outcomes of Prompt Mental Health Care: A randomized controlled trial.,"Prompt Mental Health Care (PMHC, Norwegian adaptation of Improving Access to Psychological Therapies) is found successful in alleviating symptoms of anxiety and depression. Here, we investigate whether improvement is maintained over time. A randomized controlled trial was conducted in two PMHC sites from November 2015 to August 2017, randomly assigning 681 adults with anxiety and/or mild to moderate depression (70:30 ratio: PMHC n = 463, TAU n = 218). Main outcomes were recovery rates and changes in symptoms of depression and anxiety from baseline to 12 months. Secondary outcomes were functional status, health-related quality of life, mental wellbeing and work participation. At 12 months after baseline the reliable recovery rate was 59.4% in PMHC and 36.6% in TAU, giving a between-group effect size of 0.51 (95%CI: 0.26, 0.77, p < 0.001). Differences in symptom change gave between-group effect sizes of -0.67 (95%CI: -0.99, -0.36, p < 0.001) for depression and -0.58 (95%CI: -0.91, -0.26, p < 0.001) for anxiety. PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation. In sum, substantial treatment effects of PMHC remain at 12 months follow-up, although results should be interpreted with caution due to risk of attrition bias.",2020,"PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation.","['two PMHC sites from November 2015 to August 2017, randomly assigning 681 adults with anxiety and/or mild to moderate depression (70:30 ratio: PMHC n\xa0=\xa0463, TAU n\xa0=\xa0218']","['PMHC', '95%CI', 'Prompt Mental Health Care']","['functional status, health-related quality of life, mental wellbeing and work participation', 'functional status, health-related quality of life and mental wellbeing', 'reliable recovery rate', 'anxiety', 'recovery rates and changes in symptoms of depression and anxiety']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",681.0,0.216902,"PMHC was also at 12 months found more effective in improving functional status, health-related quality of life and mental wellbeing, but not work participation.","[{'ForeName': 'Solbjørg Makalani', 'Initials': 'SM', 'LastName': 'Myrtveit Sæther', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway. Electronic address: makalani@myrtveit.com.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Knapstad', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway; Department of Clinical Psychology, University of Bergen, Bergen, Norway. Electronic address: marit.knapstad@fhi.no.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grey', 'Affiliation': 'Sussex Partnership NHS Foundation Trust, United Kingdom; School of Psychology, University of Sussex, United Kingdom. Electronic address: n.Grey@sussex.ac.uk.'}, {'ForeName': 'Marit Aase', 'Initials': 'MA', 'LastName': 'Rognerud', 'Affiliation': 'Health Section, Oslo Municipality, Oslo, Norway. Electronic address: marogner@outlook.com.'}, {'ForeName': 'Otto R F', 'Initials': 'ORF', 'LastName': 'Smith', 'Affiliation': 'Department of Health Promotion, Norwegian Institute of Public Health, Zander Kaaes Gate 7, 5015, Bergen, Norway. Electronic address: robert.smith@fhi.no.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103758']
1551,33129501,Three-year outcomes of the postapproval study of the AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation Trial.,"OBJECTIVES


The Cox Maze IV operation is commonly performed concomitant with other cardiac operations and effectively reduces the burden of atrial fibrillation. Prospective randomized trials have reported outcomes early and at 12 months, but only single-center late durability results are available. As part of the postapproval process for a bipolar radiofrequency ablation system, we sought to determine early and midterm outcomes of patients undergoing the Cox Maze IV operation.
METHODS


A prospective, multicenter, single-arm study of 363 patients (mean age, 70 years, 82% valve surgery) with nonparoxysmal atrial fibrillation (mean duration, 60 months, 94% Congestive heart failure, Hypertension, Age ≥ 75, Diabetes, Stroke, VAScular disease, Age 65-74, Sex category ≥2) undergoing concomitant Maze IV atrial fibrillation ablation at 40 sites with 70 surgeons was performed between June 2010 and October 2014. Compliance with the study lesion set was 94.5%, and 99% had left atrial appendage closure. Freedom from atrial fibrillation was determined by extended monitoring, with a 48-hour Holter monitor minimum.
RESULTS


There were no device-related complications. Freedom from atrial fibrillation off antiarrhythmic medications at 1, 2, and 3 years was 66%, 65%, and 64%, respectively, and including those using antiarrhythmics was 80%, 78%, and 76%, respectively. Warfarin was used in 49%, 44%, and 40%, respectively.
CONCLUSIONS


In patients with nonparoxysmal atrial fibrillation, compliance with the protocol was high, and freedom from atrial fibrillation off antiarrhythmics was high and sustained to 3 years. The safety and effectiveness of the system and Cox Maze IV procedure support the Class I guideline recommendation for concomitant atrial fibrillation ablation in patients undergoing cardiac surgery.",2020,There were no device-related complications.,"['patients undergoing cardiac surgery', '363 patients (mean age, 70\xa0years, 82% valve surgery) with nonparoxysmal atrial fibrillation (mean duration, 60\xa0months, 94% Congestive heart failure, Hypertension, Age', '≥\xa075, Diabetes, Stroke, VAScular disease, Age 65-74, Sex category ≥2) undergoing concomitant Maze IV atrial fibrillation ablation at 40 sites with 70 surgeons was performed between June 2010 and October 2014', 'patients with nonparoxysmal atrial fibrillation, compliance with the protocol was high, and freedom from atrial fibrillation off antiarrhythmics was high and sustained to 3\xa0years', 'patients undergoing the Cox Maze IV operation']","['AtriCure Bipolar Radiofrequency Ablation', 'Warfarin']","['left atrial appendage closure', 'burden of atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0083355', 'cui_str': 'MAZE protocol'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}]","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",363.0,0.0391548,There were no device-related complications.,"[{'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'McCarthy', 'Affiliation': 'Division of Cardiac Surgery, Northwestern University Feinberg School of Medicine, Bluhm Cardiovascular Institute, Chicago, Ill. Electronic address: pmccart@nm.org.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gerdisch', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Franciscan St Francis Heart Center, Indianapolis, Ind.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Philpott', 'Affiliation': 'Sentara Heart Hospital, Norfolk, Va.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Barnhart', 'Affiliation': 'Swedish Heart and Vascular Institute, Swedish Medical Center, Seattle, Wash.'}, {'ForeName': 'Albert L', 'Initials': 'AL', 'LastName': 'Waldo', 'Affiliation': 'Division of Cardiovascular Medicine, Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shemin', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, School of Medicine at UCLA, Los Angeles, Calif.'}, {'ForeName': 'Adin-Cristian', 'Initials': 'AC', 'LastName': 'Andrei', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Gaynor', 'Affiliation': 'AtriCure, Inc, Mason, Ohio.'}, {'ForeName': 'Nfii', 'Initials': 'N', 'LastName': 'Ndikintum', 'Affiliation': 'AtriCure, Inc, Mason, Ohio.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Division of Cardiology, Johns Hopkins Hospital, Baltimore, Md.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.09.099']
1552,33130107,Effects of clinic-level implementation of One Key Question® on reproductive health counseling and patient satisfaction.,"OBJECTIVE


We evaluated the effect of clinic level implementation of the One Key Question (OKQ) intervention, including physician and staff training and workflow adjustments, on reproductive counseling and patient satisfaction in primary care and ob/gyn.
STUDY DESIGN


We implemented the OKQ intervention in one primary care and one ob/gyn practice, while observing another primary care and ob/gyn practice that each provided usual care (control practices). We surveyed separate patient cohorts at two time points: 26 before and 33 after the primary care practice implemented OKQ, 38 before and 36 after the ob/gyn practice implemented OKQ, 26 and 37 at the primary care control practice, and 31 and 37 at the ob/gyn control practice. We used chi square tests to assess OKQ's effects on counseling rates and patient satisfaction, comparing intervention to control practices across time points.
RESULTS


In primary care, from before to after implementation, the intervention practice did not significantly increase reproductive counseling (69-76%, p = 0.58), but increased patient satisfaction (81-97%, p = 0.04) while the control practice demonstrated a decrease in patient satisfaction over the same time periods. In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction.
CONCLUSIONS


Implementing OKQ appears to increase patient satisfaction. Larger studies are needed to assess whether this clinic-level intervention may increase reproductive counseling.
IMPLICATIONS


Further studies of the impact of clinic-level implementation of OKQ are needed.",2020,"In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction.
","['surveyed separate patient cohorts at two time points: 26 before and 33 after the primary care practice implemented OKQ, 38 before and 36 after the ob/gyn practice implemented OKQ, 26 and 37 at the primary care control practice, and 31 and 37 at the ob/gyn control practice']","['OKQ intervention in one primary care and one ob/gyn practice, while observing another primary care and ob/gyn practice that each provided usual care (control practices']","['reproductive counseling or patient satisfaction', 'Reproductive Health Counseling and Patient Satisfaction', 'reproductive counseling', 'patient satisfaction']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0474170', 'cui_str': 'Reproductive education'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",,0.0306413,"In the ob/gyn clinics, no significant change in reproductive counseling or patient satisfaction was seen in the intervention practice, while the control practice demonstrated a decrease in patient satisfaction.
","[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104, Chicago, IL 60637, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'White VanGompel', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104, Chicago, IL 60637, USA; Department of Family Medicine, University of Chicago, 5841 S Maryland Ave., MC 7110, Chicago, IL 60637, USA; NorthShore University HealthSystem (NSUHS) Research Institute, 1001 University Pl, Evanston, IL, 60201, USA.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NorthShore University HealthSystem (NSUHS) Research Institute, 1001 University Pl, Evanston, IL, 60201, USA.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Guzman', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104, Chicago, IL 60637, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Carlock', 'Affiliation': 'NorthShore University HealthSystem (NSUHS) Research Institute, 1001 University Pl, Evanston, IL, 60201, USA.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Schueler', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104, Chicago, IL 60637, USA.'}, {'ForeName': 'Debra B', 'Initials': 'DB', 'LastName': 'Stulberg', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, 924 E 57th St, Ste #104, Chicago, IL 60637, USA; Department of Family Medicine, University of Chicago, 5841 S Maryland Ave., MC 7110, Chicago, IL 60637, USA. Electronic address: stulberg@uchicago.edu.'}]",Contraception,['10.1016/j.contraception.2020.10.018']
1553,33130139,Single versus Double Burr Hole for Drainage of Chronic Subdural Hematoma: Randomized Controlled Study.,"BACKGROUND


Chronic subdural hematoma (CSDH) is one of the most common neurosurgical emergencies. Most neurosurgeons currently drained CSDH through single or double burr holes; however, few studies have compared the 2 approaches to drainage. The aim of this study is to compare the recurrent rate following double and single burr hole for CSDH in our practice.
METHODS


This is a randomized controlled study from January 2015 to December 2019 in a neurosurgical unit in Kaduna, Nigeria. All patients with imaging diagnosis of subacute or chronic subdural hematoma who enrolled in the study had either a single or double burr hole. Patients were followed up for 6 months after surgery to assess for recurrence. Data were analyzed using SPSS version 25 for Windows. The Fisher exact test was performed to compare the 2 treatment groups. A 2-sided P value < 0.05 was considered statistically significant.
RESULTS


A total of 192 patients were enrolled in the study with 99 in the single-burr hole group and 93 in the double burr-hole group. The overall recurrence rate in this study was 2.6%. The recurrence rate in the single arm was 3%, and in the double arm it was 2.2%. There was no statistically significant difference in recurrence between the 2 groups (P = 1.000).
CONCLUSIONS


A single burr hole is as efficacious as a double burr hole in terms of relief of symptoms and recurrence, and it has a shorter duration of surgery.",2020,,['chronic subdural haematoma'],[],[],"[{'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}]",[],[],,0.20227,,"[{'ForeName': 'Danjuma', 'Initials': 'D', 'LastName': 'Sale', 'Affiliation': 'Department of Surgery, College of Medicine, Kaduna State University, Kaduna, Nigeria. Electronic address: doplass@yahoo.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.10.140']
1554,33131932,The respiratory syncytial virus fusion protein-specific B cell receptor repertoire reshaped by post-fusion subunit vaccination.,"Respiratory syncytial virus (RSV) is the major cause of acute lower respiratory illness in children of less than 5 years of age which usually results in hospitalization or even in death. Vaccine development is hampered in consequence of a failed vaccine trial with fatalities in the 1960s. Even though research has been more focused on the RSV fusion protein in its pre-fusion conformation, maternal vaccination with post-fusion protein (post F) was considered as a promising vaccine strategy for passive immunization of babies, because post F preserves very potent neutralizing epitopes. We extensively analyzed post F-binding B cell receptor (BCR) repertoires of three vaccinees who received a post F-subunit vaccine in the context of a first-in-human, Phase 1, randomized, observer-blind, placebo-controlled clinical trial (ClinicalTrials.gov Identifier: NCT02298179). In order to compare the vaccine-induced BCR repertoires with BCR repertoires induced by natural infection, we also analyzed pre F- and post F-binding BCRs isolated from a healthy blood donor with relatively high F-binding memory B cell (MBC) frequencies. Analysis of the vaccine-induced repertoires revealed that preferentially V H 4-encoded BCRs were expanded in response to vaccination. Estimation of antigen-driven selection further demonstrated that expanded BCRs accumulated positively selected replacement mutations which substantiated the hypothesis that post F-vaccination induces diversification of V H 4-encoded BCRs in germinal centers. Comparison of the vaccine-induced BCR repertoires with clonally related pre and post F-binding BCRs of the healthy blood donor suggested that the vaccine expanded pre/post F cross-reactive MBCs. Interestingly, several vaccine-induced BCRs shared stereotypic VDJ gene junctions with known neutralizing Abs. Once expressed for functional characterization, the selected monoclonal Abs demonstrated the predicted neutralization activities in plaque reduction neutralization assays indicating that the post F-vaccine induced expansion of neutralizing BCRs.",2020,"Once expressed for functional characterization, the selected monoclonal Abs demonstrated the predicted neutralization activities in plaque reduction neutralization assays indicating that the post F-vaccine induced expansion of neutralizing BCRs.",['children of less than 5 years of age which usually results in hospitalization or even in death'],['placebo'],['BCR repertoires'],"[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034789', 'cui_str': 'B-cell antigen receptor'}]",,0.110245,"Once expressed for functional characterization, the selected monoclonal Abs demonstrated the predicted neutralization activities in plaque reduction neutralization assays indicating that the post F-vaccine induced expansion of neutralizing BCRs.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Schneikart', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy; Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Tavarini', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: simona.x.tavarini@gsk.com.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Sammicheli', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: chiara.x.sammicheli@gsk.com.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Torricelli', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: giulia.x.torricelli@gsk.com.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Guidotti', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: silvia.x.guidotti@gsk.com.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Andreano', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy; Department of Life Sciences, University of Siena, Via Aldo Moro 2, 53100 Siena, Italy. Electronic address: e.andreano@toscanalifesciences.org.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Buricchi', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: francesca.x.buricchi@gsk.com.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': ""D'Oro"", 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: ugo.x.doro@gsk.com.'}, {'ForeName': 'Oretta', 'Initials': 'O', 'LastName': 'Finco', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: oretta.x.finco@gsk.com.'}, {'ForeName': 'Monia', 'Initials': 'M', 'LastName': 'Bardelli', 'Affiliation': 'GSK, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: monia.x.bardelli@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2020.10.062']
1555,33131933,Immunogenicity and safety of a modified three-dose priming and booster schedule for the Hantaan virus vaccine (Hantavax): A multi-center phase III clinical trial in healthy adults.,"BACKGROUND


Hemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries. This study aimed to evaluate the immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax®) with a 3 + 1 vaccination schedule.
METHODS


A phase III, multi-center clinical trial was conducted to evaluate the immunogenicity and safety of Hantavax® (three primary doses and a booster dose schedule at 0, 1, 2 and 13 months) among healthy adults. Immune responses were assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Systemic and local adverse events were assessed.
RESULTS


A total of 320 healthy subjects aged ≥19 years were enrolled. Following three primary doses of Hantavax®, the seroconversion rate was 80.97% and 92.81% by PRNT and IFA, respectively. With booster administration, seropositive rates were 67.47% and 95.68% at one-month post-vaccination according to PRNT and IFA, respectively. Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses. Both local and systemic adverse events did not increase with repeated vaccinations.
CONCLUSION


Hantavax® showed a high seroconversion rate after the three-dose priming, and additional dose administration with 11-month interval induced good booster effects. (ClinicalTrials.gov Identifier: NCT02553837).",2020,"Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses.","['320 healthy subjects aged ≥19\xa0years were enrolled', 'healthy adults', 'Hantaan virus vaccine (Hantavax']","['Hantavax®', 'formalin-inactivated Hantaan virus vaccine (Hantavax®']","['seroconversion rate', 'Immunogenicity and safety', 'immunogenicity and safety', 'Systemic and local adverse events', 'plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA', 'seropositive rates', 'Solicited local and systemic adverse events']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086384', 'cui_str': 'Hantaan virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0086384', 'cui_str': 'Hantaan virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183489', 'cui_str': 'Immunofluorescent stain'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}]",320.0,0.109589,"Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses.","[{'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Won', 'Initials': 'HW', 'LastName': 'Jeong', 'Affiliation': 'Division of Infectious Diseases, Chungbuk National University College of Medicine, Cheongju, Chungcheongbuk-do, Republic of Korea.'}, {'ForeName': 'Jong Woo', 'Initials': 'JW', 'LastName': 'Yun', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Gangwon-do, Republic of Korea.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heung Jeong', 'Initials': 'HJ', 'LastName': 'Woo', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Dongtan Sacred Heart Hospital , Hallym University College of Medicine, Hwasung, Republic of Korea.'}, {'ForeName': 'Joon-Yong', 'Initials': 'JY', 'LastName': 'Bae', 'Affiliation': 'Department of Microbiology, Institute for Viral Diseases, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Man-Seong', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Microbiology, Institute for Viral Diseases, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Suk', 'Initials': 'WS', 'LastName': 'Choi', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dae Won', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yun', 'Initials': 'JY', 'LastName': 'Noh', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Cheong', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Woo Joo', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: wjkim@korea.ac.kr.'}]",Vaccine,['10.1016/j.vaccine.2020.10.035']
1556,33130414,Effects of the school environment on early sexual risk behavior: A longitudinal analysis of students in English secondary schools.,"INTRODUCTION


The theory of human functioning and school organization proposes that schools promote health by strengthening students' educational engagement. Previous studies have relied on proxy measures of engagement and not examined sexual health. This paper addresses these gaps.
METHODS


Longitudinal data came from the control arm of a randomized trial involving female and male students ages 12-14 in English secondary-schools (n = 3337 students). Exposures measured at baseline included a proxy measure of school-level engagement (value-added education, VAE: the difference between observed absence and attainment rates and those predicted based on student characteristics) and direct measures of school- and student-level engagement (commitment, belonging, relationships and participation). Sexual behavior was measured at 24- and 36-months, including sexual debut and contraception use at first sex.
RESULTS


Higher school-level VAE was associated with an increased risk of early sexual debut at 24-months. Students attending schools with higher overall levels of commitment and belonging were less likely to report sexual debut at 36 months. Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points. Associations involving participation and contraception use were largely nonsignificant.
CONCLUSIONS


Direct measures of the school environment are more strongly associated with reduced sexual risk behavior in early adolescence than the proxy measure, VAE. Results provide some support for the theory and suggest that personal disposition towards school as well as attending a school with high levels of student commitment and belonging are important for subsequent sexual decision making.",2020,Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points.,"['students in English secondary schools', 'Students attending schools with higher overall levels of commitment and belonging were less likely to report sexual debut at 36 months', 'Longitudinal data came from the control arm of a randomized trial involving female and male students ages 12-14 in English secondary-schools (n\xa0=\xa03337 students']",['school environment'],"['proxy measure of school-level engagement (value-added education, VAE: the difference between observed absence and attainment rates and those predicted based on student characteristics) and direct measures of school- and student-level engagement (commitment, belonging, relationships and participation', 'Sexual behavior', 'sexual risk behavior', 'early sexual risk behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",3337.0,0.0245885,Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points.,"[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: amy.peterson@etr.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1H 9SH, UK. Electronic address: elizabeth.allen@lshtm.ac.uk.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'UCL Great Ormand Street Institute of Child Health, 30 Guilford Street, London WC1N 1EH, UK. Electronic address: r.viner@ucl.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: chris.bonell@lshtm.ac.uk.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.10.004']
1557,33130477,"A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation powder (CVT-301, Inbrija) in patients with Parkinson's disease.","INTRODUCTION


CVT-301 (Inbrija™) is a levodopa inhalation powder for on-demand treatment of OFF episodes in Parkinson's disease patients treated with carbidopa/levodopa. Safety and efficacy results of a 12-month, dose-level blinded extension study of a phase 3 trial (SPAN-PD) of CVT-301 are presented.
METHODS


Patients were receiving oral carbidopa/levodopa and adjunctive CVT-301 treatment, blinded to dose (60 mg or 84 mg, N = 325). Study visits occurred every 3 months. Pulmonary function was assessed by spirometry. Other safety assessments included dyskinesia and adverse events (AEs). Secondary objectives of the study included maintenance of improvement assessments for occurrence of an ON state during the 60-min post-dose period, change in total daily OFF time, and Patient Global Impression of Change (PGIC).
RESULTS


Most frequent AEs (≥5%) were cough (15.4%), fall (13.1%), upper respiratory tract infection (7.1%), and dyskinesia (5.1%). Severe AEs (>1 event) were cough (1.9%) and dyskinesia (0.6%). Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO  were -0.092 L, -0.097 L, and -0.922 mL/min/mmHg, respectively. At 12 months, 73.0% of patients on 84 mg achieved an ON state within 60 min. Total daily OFF time was reduced by 0.55 h (month 1) and 0.88 h (month 12) for the 84 mg dose. Percentage of patients self-reported as improved by PGIC was 65.5-91.9% over 12 months.
CONCLUSION


CVT-301 was generally well-tolerated. Twelve-month decline in pulmonary function was consistent with a prior PD control group. Exploratory efficacy results showed CVT-301 maintained improvement at achieving ON states in patients experiencing OFF episodes, decreasing daily OFF time, and maintaining improvement in PGIC.",2020,"Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO  were -0.092 ","[""Parkinson's disease patients treated with"", 'Patients were receiving', ""patients with Parkinson's disease""]","['levodopa inhalation powder (CVT-301, Inbrija', 'carbidopa/levodopa', 'oral carbidopa/levodopa and adjunctive CVT-301 treatment', 'CVT-301 (Inbrija™']","['dyskinesia and adverse events (AEs', 'upper respiratory tract infection', 'daily OFF time, and maintaining improvement in PGIC', 'cough', 'PGIC', 'Safety and efficacy', 'pulmonary function', 'FEV 1 , FVC, and DL CO', 'Total daily OFF time', 'tolerated', 'total daily OFF time, and Patient Global Impression of Change (PGIC', 'Pulmonary function', 'dyskinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4745728', 'cui_str': 'Levodopa Inhalation Powder'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C4745523', 'cui_str': 'Inbrija'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0315546,"Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO  were -0.092 ","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Farbman', 'Affiliation': 'Roseman University of Health Sciences, 5380 South Rainbow Boulevard, Suite 120, Las Vegas, NV, USA. Electronic address: efarbman@roseman.edu.'}, {'ForeName': 'Cheryl H', 'Initials': 'CH', 'LastName': 'Waters', 'Affiliation': 'Columbia University Medical Center, 710 West 168th Street; New York, NY, 10032, USA. Electronic address: cw345@columbia.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'LeWitt', 'Affiliation': 'Department of Neurology, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, 48322, USA. Electronic address: plewitt1@hfhs.org.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rudzińska', 'Affiliation': 'Department of Neurology, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland. Electronic address: mrudzinska@sum.edu.pl.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klingler', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: miklingler@gmail.com.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: angela.lee.ny.10023@gmail.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: Jennyqian01@gmail.com.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Inc., 420 Saw Mill River Road, Ardsley, NY, 10502, USA. Electronic address: opus99@hotmail.com.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center, University of South Florida, 4001 East Fletcher Ave, 6th Floor, Tampa, FL, 33613, USA. Electronic address: rhauser@usf.edu.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.029']
1558,33130482,"A randomized study investigating the safety, tolerability, and pharmacokinetics of evinacumab, an ANGPTL3 inhibitor, in healthy Japanese and Caucasian subjects.","BACKGROUND AND AIMS


Evinacumab, an angiopoietin-like protein 3 monoclonal antibody, reduced low-density lipoprotein cholesterol (LDL-C) significantly in a Phase 2 study of patients with homozygous familial hypercholesterolemia. In this double-blind, placebo-controlled Phase 1 study, we compared safety, tolerability, pharmacokinetics, and pharmacodynamics of evinacumab between healthy Japanese and Caucasian adults.
METHODS


Subjects with LDL-C ≥2.6 and <4.1 mmol/L were enrolled to one of four dose cohorts: evinacumab subcutaneous (SC) 300 mg single dose, SC 300 mg once weekly for eight doses, intravenous (IV) 5 mg/kg, or IV 15 mg/kg once every 4 weeks for two doses. Each cohort comprised 24 subjects (12 Japanese; 12 Caucasian), randomized (3:1) to receive evinacumab or placebo within each ethnic group with a 24-week follow-up.
RESULTS


The safety profile of evinacumab (IV and SC) in both ethnicities was comparable with placebo, with no serious or severe treatment-emergent adverse events. Pharmacokinetic profiles were comparable between Japanese and Caucasian subjects across IV and SC groups. Mean calculated LDL-C decreased from baseline with both IV doses, beginning on day 3 up to week 8. Triglyceride changes observed with evinacumab IV were rapid (seen by day 2) and sustained up to week 8. Evinacumab SC doses also reduced LDL-C and triglyceride levels, although lower doses induced smaller changes. Evinacumab (IV and SC) reduced other lipids, including apolipoprotein B, versus placebo.
CONCLUSIONS


In both ethnicities, evinacumab (IV and SC) was generally well tolerated, exhibiting comparable pharmacokinetic profiles. Dose-related reductions in LDL-C and triglycerides were observed with evinacumab in both ethnic groups.",2020,"The safety profile of evinacumab (IV and SC) in both ethnicities was comparable with placebo, with no serious or severe treatment-emergent adverse events.","['healthy Japanese and Caucasian adults', '24 subjects (12 Japanese; 12 Caucasian', 'Subjects with LDL-C ≥2.6 and <4.1\xa0mmol/L were enrolled to one of four dose cohorts', 'healthy Japanese and Caucasian subjects', 'patients with homozygous familial hypercholesterolemia']","['evinacumab subcutaneous (SC) 300\xa0mg single dose, SC', 'evinacumab or placebo', 'Evinacumab (IV and SC', 'Evinacumab SC', 'placebo', 'evinacumab', 'evinacumab (IV and SC']","['safety, tolerability, and pharmacokinetics', 'Mean calculated LDL-C', 'LDL-C and triglyceride levels', 'Pharmacokinetic profiles', 'LDL-C and triglycerides', 'Triglyceride changes', 'safety, tolerability, pharmacokinetics, and pharmacodynamics of evinacumab']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342881', 'cui_str': 'Familial hypercholesterolemia - homozygous'}]","[{'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C4508522', 'cui_str': 'evinacumab'}]",,0.106665,"The safety profile of evinacumab (IV and SC) in both ethnicities was comparable with placebo, with no serious or severe treatment-emergent adverse events.","[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Harada-Shiba', 'Affiliation': 'Department of Molecular Innovation in Lipidology, National Cerebral and Cardiovascular Center Research Institute, Suita, Osaka, Japan. Electronic address: mshiba@ncvc.go.jp.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gipe', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Gasparino', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Son', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences University of Milan and IRCCS Multimedica, Milan, Italy.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.10.013']
1559,33136053,Integrating a Mobile Health Device Into a Community Youth Mental Health Team to Manage Severe Mental Illness: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Symptoms of mental illness are often triggered by stress, and individuals with mental illness are sensitive to these effects. The development of mobile health (mHealth) devices allows continuous recording of biometrics associated with activity, sleep, and arousal. Deviations in these measures could indicate a stressed state requiring early intervention. This paper describes a protocol for integrating an mHealth device into a community mental health team to enhance management of severe mental illness in young adults.
OBJECTIVE


The aim of this study is to examine (1) whether an mHealth device integrated into a community mental health team can improve outcomes for young adults with severe mental illness and (2) whether the device detects periods of mental health versus deterioration.
METHODS


This study examines whether physiological information from an mHealth device prevents mental deterioration when shared with the participant and clinical team versus with the participant alone. A randomized controlled trial (RCT) will allocate 126 young adults from community mental health services for 6 months to standard case management combined with an integrated mHealth device (ie, physiological information is viewed by both participant and case manager: unWIRED intervention) or an unintegrated mHealth device (ie, participant alone self-monitors: control). Participants will wear the Empatica Embrace2 device, which continuously records electrodermal activity and actigraphy (ie, rest and activity). The study also examines whether the Embrace2 can detect periods of mental health versus deterioration. A variety of measurements will be taken, including physiological data from the Embrace2; participant and case manager self-report regarding symptoms, functioning, and quality of life; chart reviews; and ecological momentary assessments of stress in real time. Changes in each participant's Clinical Global Impression Scale scores will be assessed by blinded raters as the primary outcome. In addition, participants and case managers will provide qualitative data regarding their experience with the integrated mHealth device, which will be thematically analyzed.
RESULTS


The study has received ethical approval from the Western Sydney Local Health District Human Research Ethics Committee. It is due to start in October 2020 and conclude in October 2022.
CONCLUSIONS


The RCT will provide insight as to whether an integrated mHealth device enables case managers and participants to pre-emptively manage early warning signs and prevent relapse. We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000642987; https://www.anzctr.org.au/ACTRN12620000642987.aspx.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19510.",2020,"We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
","['young adults', 'young adults with severe mental illness and (2', '126 young adults from community mental health services for 6 months to']","['standard case management combined with an integrated mHealth device (ie, physiological information is viewed by both participant and case manager: unWIRED intervention) or an unintegrated mHealth device (ie, participant alone self-monitors: control', 'mHealth device integrated into a community mental health team', 'ANZCTR']","['Clinical Global Impression Scale scores', 'electrodermal activity and actigraphy (ie, rest and activity', 'mental deterioration']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0687694', 'cui_str': 'Case manager'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",126.0,0.384448,"We anticipate that unWIRED will enhance early intervention by improving detection of stress and allowing case managers and patients to better engage and respond to symptoms.
","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Western Sydney Local Health District Mental Health Service, Sydney, NSW, Australia.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Kotze', 'Affiliation': 'Rivendell Child Adolescent and Family Unit, Sydney, Australia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ramos', 'Affiliation': 'School of Computer Science, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Casties', 'Affiliation': 'Westmead Institute for Medical Research, Sydney, Australia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Starling', 'Affiliation': 'Concord Centre for Mental Health, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Harris', 'Affiliation': 'Western Sydney Local Health District Mental Health Service, Sydney, NSW, Australia.'}]",JMIR research protocols,['10.2196/19510']
1560,33137293,"Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials.","BACKGROUND


The melanocortin 4 receptor (MC4R), a component of the leptin-melanocortin pathway, plays a part in bodyweight regulation. Severe early-onset obesity can be caused by biallelic variants in genes that affect the MC4R pathway. We report the results from trials of the MC4R agonist setmelanotide in individuals with severe obesity due to either pro-opiomelanocortin (POMC) deficiency obesity or leptin receptor (LEPR) deficiency obesity.
METHODS


These single-arm, open-label, multicentre, phase 3 trials were done in ten hospitals across Canada, the USA, Belgium, France, Germany, the Netherlands, and the UK. Participants aged 6 years or older with POMC or LEPR deficiency obesity received open-label setmelanotide for 12 weeks. Participants with at least 5 kg weight loss (or ≥5% if weighing <100 kg at baseline) entered an 8-week placebo-controlled withdrawal sequence (including 4 weeks each of blinded setmelanotide and placebo treatment) followed by 32 additional weeks of open-label treatment. The primary endpoint, which was assessed in participants who received at least one dose of study medication and had a baseline assessment (full analysis set), was the proportion of participants with at least 10% weight loss compared with baseline at approximately 1 year. A key secondary endpoint was mean percentage change in the most hunger score of the 11-point Likert-type scale at approximately 1 year on the therapeutic dose, which was assessed in a subset of participants aged 12 years or older in the full analysis set who demonstrated at least 5 kg weight loss (or ≥5% in paediatric participants if baseline bodyweight was <100 kg) over the 12-week open-label treatment phase and subsequently proceeded into the placebo-controlled withdrawal sequence, regardless of later disposition. These studies are registered with ClinicalTrials.gov, NCT02896192 and NCT03287960.
FINDINGS


Between Feb 14, 2017, and Sept 7, 2018, ten participants were enrolled in the POMC trial and 11 participants were enrolled in the LEPR trial, and included in the full analysis and safety sets. Eight (80%) participants in the POMC trial and five (45%) participants in the LEPR trial achieved at least 10% weight loss at approximately 1 year. The mean percentage change in the most hunger score was -27·1% (n=7; 90% CI -40·6 to -15·0; p=0·0005) in the POMC trial and -43·7% (n=7; -54·8 to -29·1; p<0·0001) in the LEPR trial. The most common adverse events were injection site reaction and hyperpigmentation, which were reported in all ten participants in the POMC trial; nausea was reported in five participants and vomiting in three participants. In the LEPR trial, the most commonly reported treatment-related adverse events were injection site reaction in all 11 participants, skin disorders in five participants, and nausea in four participants. No serious treatment-related adverse events occurred in both trials.
INTERPRETATION


Our results support setmelanotide for the treatment of obesity and hyperphagia caused by POMC or LEPR deficiency.
FUNDING


Rhythm Pharmaceuticals.",2020,n=7; 90% CI -40·6 to -15·0; p=0·0005) in the POMC trial and -43·7% (,"['Between Feb 14, 2017, and Sept 7, 2018', 'individuals with severe obesity due to LEPR or POMC deficiency', ' ten participants were enrolled in the POMC trial and 11 participants were enrolled in the LEPR trial, and included in the full analysis and safety sets', 'individuals with severe obesity due to either pro-opiomelanocortin (POMC) deficiency obesity or leptin receptor (LEPR) deficiency obesity', 'Participants aged 6 years or older with POMC or LEPR deficiency obesity received', 'Participants with at least 5 kg weight loss (or ≥5% if weighing <100 kg at baseline) entered an 8-week']","['setmelanotide', 'open-label setmelanotide', 'placebo-controlled withdrawal sequence', 'MC4R agonist setmelanotide']","['weight loss', 'Severe early-onset obesity', 'adverse events', 'nausea', 'vomiting', 'hunger score of the 11-point Likert-type scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0385463', 'cui_str': 'Receptor, Leptin'}, {'cui': 'C0033195', 'cui_str': 'Pro-opiomelanocortin'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0527721', 'cui_str': 'MC4R protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",10.0,0.273751,n=7; 90% CI -40·6 to -15·0; p=0·0005) in the POMC trial and -43·7% (,"[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clément', 'Affiliation': 'Assistance Publique Hôpitaux de Paris, Nutrition Department, Pitié-Salpêtrière Hospital, Paris, France; Sorbonne Université, INSERM, NutriOmics Research Unit, Paris, France.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'van den Akker', 'Affiliation': ""Division of Pediatric Endocrinology, Department of Pediatrics, Sophia Children's Hospital and Obesity Center CGG, Erasmus University Medical Center, Rotterdam, Netherlands.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Argente', 'Affiliation': 'Department of Pediatrics and Pediatric Endocrinology, Universidad Autónoma de Madrid, University Hospital Niño Jesús, CIBER ""Fisiopatología de la obesidad y nutrición"" (CIBEROBN), Instituto de Salud Carlos III, IMDEA Institute, Madrid, Spain.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Bahm', 'Affiliation': 'Peel Memorial Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Chung', 'Affiliation': 'Department of Pediatrics and Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hillori', 'Initials': 'H', 'LastName': 'Connors', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'De Waele', 'Affiliation': 'Department of Pediatric and Adolescent Endocrinology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'I Sadaf', 'Initials': 'IS', 'LastName': 'Farooqi', 'Affiliation': 'Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Gonneau-Lejeune', 'Affiliation': 'Université de la Réunion, Unité Transversale de Nutrition Clinique, CHU de la Réunion, Réunion, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Gordon', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kohlsdorf', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Center for Rare Endocrine Diseases, Department of Pediatrics and Adolescent Medicine, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Poitou', 'Affiliation': 'Assistance Publique Hôpitaux de Paris, Nutrition Department, Pitié-Salpêtrière Hospital, Paris, France; Sorbonne Université, INSERM, NutriOmics Research Unit, Paris, France.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Puder', 'Affiliation': 'Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Department for Pediatric Endocrinology and Diabetology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Swain', 'Affiliation': 'HonorHealth Bariatric Center, Scottsdale, AZ, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Yuan', 'Affiliation': 'Rhythm Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wabitsch', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Center for Rare Endocrine Diseases, Department of Pediatrics and Adolescent Medicine, University of Ulm, Ulm, Germany. Electronic address: martin.wabitsch@uniklinik-ulm.de.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kühnen', 'Affiliation': 'Institute for Experimental Pediatric Endocrinology, Charité Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany. Electronic address: peter.kuehnen@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30364-8']
1561,33137352,The relationship between exercise intensity and neurophysiological responses to food stimuli in women: A randomized crossover event-related potential (ERP) study.,"We tested the effect of different intensities of acute exercise on hunger, and post-exercise energy intake, and neurophysiological measures of attention towards food- and non-food stimuli in women. In a within-subjects crossover design, forty-two women completed no exercise, moderate-intensity exercise, and vigorous-intensity exercise sessions separated by one week, in a counterbalanced fashion. At each session, participants completed a passive viewing task of food (high- and low-calorie) and non-food pictures while electroencephalogram (EEG) data were recorded. The early posterior negativity (EPN), P3, and late positive potential (LPP) components of the event-related potential (ERP) measured neurophysiological responses. Subjective ratings of hunger were measured before and immediately after each condition using a visual analog scale (VAS) and food intake was measured using an ad libitum snack buffet offered at the end of each condition. Results indicated that hunger levels increased as time passed for all sessions. EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food stimuli. LPP amplitude did not differ by high-calorie, low-calorie, or non-food images. Notably, there were no significant main effects or interactions of any ERP component amplitude as a function of exercise intensity. Food intake also did not differ by rest or moderate or vigorous exercise, although subjective arousal ratings to the images were higher after moderate and vigorous exercise compared to rest. Food images also had higher arousal and valence ratings than non-food images overall. Findings indicate that, in this sample, acute moderate and vigorous exercise compared to rest did not disproportionately affect neurophysiological measures of attention to food or non-food stimuli, caloric intake, or hunger.",2020,EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food items.,['women'],['passive viewing task of food (high- and low-calorie) and non-food pictures while electroencephalogram (EEG'],"['neurophysiological measures of attention to food or non-food stimuli, caloric intake, or hunger', 'higher arousal and valence ratings', 'early posterior negativity (EPN), P3, and late positive potential (LPP) components of the event-related potential (ERP) measured neurophysiological responses', 'LPP amplitude', 'subjective arousal ratings', 'visual analog scale (VAS) and food intake', 'Subjective ratings of hunger', 'EPN amplitude', 'hunger levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.0752239,EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food items.,"[{'ForeName': 'Kaylie A', 'Initials': 'KA', 'LastName': 'Carbine', 'Affiliation': 'Department of Psychology, California State University Dominguez Hills, United States of America.'}, {'ForeName': 'Jillesa', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, Brigham Young University, United States of America; Neuroscience Center, Brigham Young University, United States of America.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'LeCheminant', 'Affiliation': 'Department of Nutrition, Dietetics, and Food Science, Brigham Young University, United States of America.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bailey', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, United States of America. Electronic address: bruce_bailey@byu.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.011']
1562,33137591,How to improve social communication in aging: Pragmatic and cognitive interventions.,"Among all aspects of the linguistic and communicative competence, pragmatics seems especially vulnerable in aging, due also to cognitive decline. However, pragmatics has never been considered as an intervention target in healthy aging. Here we tested the effects of a novel training program to improve pragmatics (PragmaCom) in older adults, compared with an active cognitive control group in a randomized-controlled-trial design. Both the PragmaCom group and the control group improved in pragmatic skills such as understanding metaphors and avoiding off-topic speech, indicating that it is possible to improve pragmatics in aging both with a specific training and with a cognitive training. Individual cognitive factors predicted pragmatic improvement in the control group, while in the PragmaCom group benefits were less dependent on individual characteristics. We discuss the results in terms of pragmatic plasticity, highlighting the importance of these findings for promoting older adults' social communication and well-being.",2020,"Both the PragmaCom group and the control group improved in pragmatic skills such as understanding metaphors and avoiding off-topic speech, indicating that it is possible to improve pragmatics in aging both with a specific training and with a cognitive training.",['older adults'],['novel training program to improve pragmatics (PragmaCom'],['pragmatic skills such as understanding metaphors and avoiding off-topic speech'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0302829', 'cui_str': 'Metaphor'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0229649,"Both the PragmaCom group and the control group improved in pragmatic skills such as understanding metaphors and avoiding off-topic speech, indicating that it is possible to improve pragmatics in aging both with a specific training and with a cognitive training.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Bambini', 'Affiliation': 'Center for Neurocognition, Epistemology and Theoretical Syntax (NEtS), University School for Advanced Studies IUSS Pavia, Piazza della Vittoria 15, 27100 Pavia, Italy. Electronic address: valentina.bambini@iusspavia.it.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tonini', 'Affiliation': 'Center for Neurocognition, Epistemology and Theoretical Syntax (NEtS), University School for Advanced Studies IUSS Pavia, Piazza della Vittoria 15, 27100 Pavia, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ceccato', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, University G. d'Annunzio of Chieti-Pescara, Via Luigi Polacchi 11, 66100 Chieti, Italy.""}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Lecce', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Piazza Botta 11, 27100 Pavia, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Marocchini', 'Affiliation': 'Laboratory of Language and Cognition, University of Genoa, Via Balbi 30, 16128 Genoa, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavallini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Piazza Botta 11, 27100 Pavia, Italy.'}]",Brain and language,['10.1016/j.bandl.2020.104864']
1563,33137599,"Effects of curcumin supplementation on blood glucose, insulin resistance and androgens in patients with polycystic ovary syndrome: A randomized double-blind placebo-controlled clinical trial.","BACKGROUND


Curcumin is a biologically active phytochemical ingredient found in turmeric. It has several pharmacologic effects that might benefit patients with polycystic ovary syndrome (PCOS).
OBJECTIVE


We hypothesized curcumin to be effective in improving blood sugar levels, insulin resistance and hyperandrogenism in individuals with PCOS.
METHODS


In a randomized double-blind placebo-controlled trial, individuals with PCOS were treated with curcumin (500 mg three times daily) or placebo for 12 weeks. Primary outcome measures were fasting plasma glucose (FPG), fasting insulin (FI), sex hormone levels, and hirsutism (Ferriman-Gallwey [mFG] score). Secondary outcomes included anthropometric measurements.
RESULTS


Of 72 randomized individuals, 67 completed the trial. The two groups were comparable at baseline. At the end of the study, FPG and Dehydroepiandrosterone levels had decreased significantly in the intervention group compared to control (difference of change (post-pre) between intervention and placebo groups: -4.11 mg/dL; 95% CI: -8.35, -0.35 mg/dL; p = 0.033 and -26.53 microg/dL; 95% CI: -47.99, -4.34 µg/dL; p = 0.035, respectively). We also observed a statistically non-significant increase (p = 0.082) in Estradiol levels in the intervention group compared to control. No serious adverse events were reported throughout the trial.
CONCLUSIONS


Curcumin might be a safe and useful supplement to ameliorate PCOS-associated hyperandrogenemia and hyperglycemia. However, longer trials investigating different dosages in longer durations are needed to underpin these findings.",2020,"At the end of the study, FPG and Dehydroepiandrosterone levels had decreased significantly in the intervention group compared to control (difference of change (post-pre) between intervention and placebo groups: -4.11 mg/dL; 95% CI: -8.35, -0.35 mg/dL; p = 0.033 and -26.53 microg/dL; 95% CI: -47.99, -4.34 µg/dL; p = 0.035, respectively).","['patients with polycystic ovary syndrome', '72 randomized individuals', 'individuals with PCOS', 'patients with polycystic ovary syndrome (PCOS']","['placebo', 'curcumin supplementation', 'curcumin']","['Estradiol levels', 'fasting plasma glucose (FPG), fasting insulin (FI), sex hormone levels, and hirsutism (Ferriman-Gallwey [mFG] score', 'blood glucose, insulin resistance and androgens', 'blood sugar levels, insulin resistance and hyperandrogenism', 'anthropometric measurements', 'FPG and Dehydroepiandrosterone levels', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0206081', 'cui_str': 'Hyperandrogenization syndrome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.755846,"At the end of the study, FPG and Dehydroepiandrosterone levels had decreased significantly in the intervention group compared to control (difference of change (post-pre) between intervention and placebo groups: -4.11 mg/dL; 95% CI: -8.35, -0.35 mg/dL; p = 0.033 and -26.53 microg/dL; 95% CI: -47.99, -4.34 µg/dL; p = 0.035, respectively).","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Heshmati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Breast Disease Research Center(BDRC), Tehran University Of Medical Sciences, Tehran, Iran; Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran; Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.""}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Sepidarkish', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Morvaridzadeh', 'Affiliation': 'Department of Nutritional Science, School of Nutritional Science and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Andriko', 'Initials': 'A', 'LastName': 'Palmowski', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maryam Farid', 'Initials': 'MF', 'LastName': 'Mojtahedi', 'Affiliation': ""Department of Obstetrics and Gynecology, Endocrinology and Female Infertility Unit, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: m_fmojtahedi@tums.ac.ir.""}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shidfar.f@iums.ac.ir.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153395']
1564,33137600,Comorbid posttraumatic stress disorder and major depressive disorder: The usefulness of a sequential treatment approach within a randomised design.,"Cognitive Processing Therapy (CPT) and Behavioural Activation Therapy (BA) were used to treat individuals with comorbid posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Fifty-two individuals (48 women, 4 men) were randomized to CPT alone (n = 18), CPT then BA for MDD (n = 17), or BA then CPT (n = 17). Presenting trauma was primarily interpersonal (87 %). Participants were assessed at pre-, posttreatment, and 6-month follow-up. PTSD and MDD symptoms were the main outcome of interest; trauma cognitions, rumination, and emotional numbing were secondary outcomes. All groups showed sizeable reductions in PTSD and depression (effect sizes at follow-up ranging between 1.02-2.54). A pattern of findings indicated CPT/BA showed better outcomes in terms of larger effect sizes and loss of diagnoses relative to CPT alone and BA/CPT. At follow-up greater numbers of the CPT/BA group were estimated to have achieved good end-state for remission of both PTSD and depression (49 %, CI 95  [.26, .73]) relative to CPT alone (18 %, CI 95  [.03, .38]) and BA/CPT (11 %, CI 95  [.01, .29]). Although tempered by the modest sample size, the findings suggest that individuals with comorbid PTSD and MDD may benefit from having PTSD targeted first before remaining MDD symptoms are addressed.",2020,All groups showed sizeable reductions in PTSD and depression (effect sizes at follow-up ranging between 1.02-2.54).,"['Fifty-two individuals (48 women, 4 men', 'individuals with comorbid posttraumatic stress disorder (PTSD) and major depressive disorder (MDD', 'Comorbid posttraumatic stress disorder and major depressive disorder']","['CPT alone', 'CPT', 'Cognitive Processing Therapy (CPT) and Behavioural Activation Therapy (BA']","['PTSD and depression (effect sizes', 'interest; trauma cognitions, rumination, and emotional numbing', 'PTSD and MDD symptoms']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0666769,All groups showed sizeable reductions in PTSD and depression (effect sizes at follow-up ranging between 1.02-2.54).,"[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Angelakis', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: samantha.angelakis@flinders.edu.au.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Weber', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: nathan.weber@flinders.edu.au.'}, {'ForeName': 'Reginald D V', 'Initials': 'RDV', 'LastName': 'Nixon', 'Affiliation': 'School of Psychology, Flinders University, GPO Box 2100, Adelaide, SA 5001, Australia. Electronic address: reg.nixon@flinders.edu.au.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102324']
1565,33137602,"But first, coffee: The roles of arousal and inhibition in the resistance of compulsive cleansing in individuals with high contamination fears.","Inhibition plays a crucial role in reducing intrusive thoughts and compulsive behaviors, such as handwashing, in response to the feeling of disgust. The current study examines whether manipulating arousal can facilitate inhibition and the resistance of compulsive cleansing. Forty-seven participants with high contamination fears were recruited for this study. Participants were divided into a caffeine group or a no-caffeine group. Participants touched a potentially contaminated and disgusting stimulus (""dirty"" diapers) and were asked to wait as long as they could before washing their hands. Only the caffeine group exhibited greater pre-post stop-signal reaction time improvement in the stop-signal task, indicating improved inhibition. Participants in the caffeine group exhibited significantly lower subjective distress and urges-to-wash their hands both after touching the stimulus and while waiting to engage in the cleansing behavior. Similarly, the caffeine group resisted the urge to compulsively cleanse for about twice as long as those in the no-caffeine group. Time spent washing, subjective distress levels, and urge-to-wash levels after participants washed their hands were similar between groups. The current findings support the notion that increased arousal improves inhibition, which may play a role in improving our ability to resist intrusive disgust and compulsive cleansing behaviors.",2020,Participants in the caffeine group exhibited significantly lower subjective distress and urges-to-wash their hands both after touching the stimulus and while waiting to engage in the cleansing behavior.,"['individuals with high contamination fears', 'Forty-seven participants with high contamination fears']","['caffeine', 'caffeine group or a no-caffeine']","['subjective distress', 'urge to compulsively cleanse', 'Time spent washing, subjective distress levels, and urge-to-wash levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1547959', 'cui_str': 'Wash'}]",47.0,0.0193422,Participants in the caffeine group exhibited significantly lower subjective distress and urges-to-wash their hands both after touching the stimulus and while waiting to engage in the cleansing behavior.,"[{'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Naftalovich', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel, Jerusalem, Israel. Electronic address: Hadar.naftalovich@mail.huji.ac.il.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Tauber', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel, Jerusalem, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel, Jerusalem, Israel.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102316']
1566,33137674,Application of carbon nanoparticles combined with intraoperative neuromonitoring in papillary thyroid microcarcinoma surgery.,"PURPOSES


To improve the lymph node dissection as well as protect parathyroid gland and recurrent laryngeal nerve, the carbon nanoparticles and intraoperative neuromonitoring were applied in papillary thyroid microcarcinoma surgery.
METHODS


Carbon nanoparticles and intraoperative neuromonitoring were used in the experimental group, whereas the control group were not. Routine pathological examination was performed.
RESULTS


The lymph nodes dissected was significantly higher in the experimental group, but the metastatic lymph nodes were not. The number of mistakenly dissected parathyroid gland and postoperative hypoparathyroidism were 3 and 13 in the experimental group respectively, significantly less than 10 and 25 in the control group. The incidences of overall, transient and persistent recurrent laryngeal nerve palsy in the experimental group were 5.5%, 5.5% and 0% respectively, whereas in the control group were 8.6%, 6.9% and 1.7%.
CONCLUSIONS


Carbon nanoparticles can improve lymph node dissection in papillary thyroid microcarcinoma surgery, and the combination of carbon nanoparticles with intraoperative neuromonitoring can reduce surgical complications and improve patient quality of life.",2020,"The incidences of overall, transient and persistent recurrent laryngeal nerve palsy in the experimental group were 5.5%, 5.5% and 0% respectively, whereas in the control group were 8.6%, 6.9% and 1.7%.
",['papillary thyroid microcarcinoma surgery'],"['carbon nanoparticles combined with intraoperative neuromonitoring', 'carbon nanoparticles and intraoperative neuromonitoring', 'Carbon nanoparticles']","['number of mistakenly dissected parathyroid gland and postoperative hypoparathyroidism', 'patient quality of life', 'incidences of overall, transient and persistent recurrent laryngeal nerve palsy']","[{'cui': 'C1709457', 'cui_str': 'Papillary Thyroid Microcarcinoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure'}, {'cui': 'C0342341', 'cui_str': 'Post-surgical hypoparathyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}]",,0.0272958,"The incidences of overall, transient and persistent recurrent laryngeal nerve palsy in the experimental group were 5.5%, 5.5% and 0% respectively, whereas in the control group were 8.6%, 6.9% and 1.7%.
","[{'ForeName': 'Taolang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: 0078029@sina.com.'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Renmin', 'Initials': 'R', 'LastName': 'Mu', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Junyuan', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Thyroid and Breast Surgery Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: cxm1688@sina.com.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Gastroenterology Department, Affiliated Hospital of Zunyi Medical University, Zunyi, China. Electronic address: onlyoneliuxuemei@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102790']
1567,33152288,Results from the PROPHYLOCHIP-PRODIGE 15 trial.,,2020,,[],[],[],[],[],[],,0.0490051,,"[{'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Tanis', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, 1100 DD Amsterdam, Netherlands. Electronic address: p.j.tanis@amsterdamumc.nl.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Cancer Centre Amsterdam, 1100 DD Amsterdam, Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Cancer Institute, Eindhoven, Netherlands; School for Oncology and Developmental Biology, Maastricht University, Maastricht, Netherlands.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30497-6']
1568,33152289,Results from the PROPHYLOCHIP-PRODIGE 15 trial.,,2020,,[],[],[],[],[],[],,0.0490051,,"[{'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Colorectal Division, Department of Gastrointestinal and Hepatobiliary Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India 400012.'}, {'ForeName': 'Diwakar', 'Initials': 'D', 'LastName': 'Pandey', 'Affiliation': 'Colorectal Division, Department of Gastrointestinal and Hepatobiliary Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India 400012.'}, {'ForeName': 'Avanish', 'Initials': 'A', 'LastName': 'Saklani', 'Affiliation': 'Colorectal Division, Department of Gastrointestinal and Hepatobiliary Surgery, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India 400012. Electronic address: asaklani@hotmail.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30624-0']
1569,33152575,"Letter to the Editor regarding ""Dexamethasone eardrop with grommet placement vs intratympanic steroid injection for sudden sensorineural hearing loss: A randomized prospective clinical trial"".",,2020,,['sudden sensorineural hearing loss'],['Dexamethasone eardrop with grommet placement vs intratympanic steroid injection'],[],"[{'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]",[],,0.0413105,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India. Electronic address: anoop.aiims1@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sagar', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102785']
1570,33152609,Effects of a 10-week running-retraining programme on the foot strike pattern of adolescents: A longitudinal intervention study.,"BACKGROUND


The purpose of this study was to analyse the effects of ten weeks of different running-retraining programmes on rearfoot strike (RFS) prevalence in adolescents.
RESEARCH QUESTION


it is possible to change foot strike pattern in adolescents?
METHODS


A total of 180 children (45.3% girls), aged 13-16 years, participated in this intervention study. The children were randomly assigned to one of three experimental groups (EGs) that each carried out a different retraining programme, based on running technique (n = 39), a 15% increased step frequency (SF) (n = 37) and barefoot training (n = 30), performed for three days each week. A control group (CG) (n = 43) did not perform any retraining. A 2D video-based analysis (240 Hz) was used to determine the RFS.
RESULTS


At baseline, no significant differences in RFS prevalence were found between the EGs and the CG in either the left (χ 2  = 2.048; p = 0.559) or the right foot (χ 2  = 0.898; p = 0.825). In the post-test, no significant differences were found for the left foot (χ 2  = 7.102; p = 0.069), but there were significant differences for the right foot (χ 2  = 9.239; p = 0.025) were observed. In the re-test, no significant differences were found for either the left foot (χ 2  = 2.665; p = 0.273) or the right foot (χ 2  = 2.182; p = 0.325). In addition, no group displayed significant changes in RFS prevalence from the pre-test to the re-test. There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
MEANING


The main finding of this study was that certain running-retraining programmes performed three times per week for ten weeks are not enough to modify the adolescent foot strike pattern (FSP).",2020,"There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
","['adolescents', '180 children (45.3% girls), aged 13-16 years']","['running-retraining programmes', '10-week running-retraining programme', 'barefoot training']","['RFS prevalence', 'rearfoot strike (RFS) prevalence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",180.0,0.0205722,"There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
","[{'ForeName': 'Pedro José', 'Initials': 'PJ', 'LastName': 'Consuegra González', 'Affiliation': 'University of Jaen, Spain. C/Sacramento, 7 Úbeda (Jaén), Spain. Electronic address: consuegragonzalezpj@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Spain; Department of Physical Education, Sports and Recreation. Universidad de La Frontera, Temuco, Chile. Electronic address: fegarpi@gmail.com.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mora López', 'Affiliation': 'I.E.S. Cañada de las Fuentes, Spain.'}, {'ForeName': 'Antonio José', 'Initials': 'AJ', 'LastName': 'Cardona Linares', 'Affiliation': 'University Pablo De Olavide of Seville, Spain. Electronic address: ajcarlin@upo.es.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Párraga Montilla', 'Affiliation': 'University of Jaen, Spain. Electronic address: jparraga@ujaen.es.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'University of Jaen, Spain. Electronic address: platorre@ujaen.es.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.024']
1571,33152672,"Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study.","BACKGROUND


The HEALing Communities Study (HCS) is designed to implement and evaluate the Communities That HEAL (CTH) intervention, a conceptually driven framework to assist communities in selecting and adopting evidence-based practices to reduce opioid overdose deaths. The goal of the HCS is to produce generalizable information for policy makers and community stakeholders seeking to implement CTH or a similar community intervention. To support this objective, one aim of the HCS is a health economics study (HES), the results of which will inform decisions around fiscal feasibility and sustainability relevant to other community settings.
METHODS


The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio. The objectives of the HES are to estimate the economic costs to communities of implementing and sustaining CTH; estimate broader societal costs associated with CTH; estimate the cost-effectiveness of CTH for overdose deaths avoided; and use simulation modeling to evaluate the short- and long-term health and economic impact of CTH, including future overdose deaths avoided and quality-adjusted life years saved, and to develop a simulation policy tool for communities that seek to implement CTH or a similar community intervention.
DISCUSSION


The HCS offers an unprecedented opportunity to conduct health economics research on solutions to the opioid crisis and to increase understanding of the impact and value of complex, community-level interventions.",2020,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","['67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio']","['CTH intervention', 'HCS', 'HEAL (CTH) intervention', 'CTH']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],,0.0271047,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","[{'ForeName': 'Arnie P', 'Initials': 'AP', 'LastName': 'Aldridge', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States. Electronic address: aaldridge@rti.org.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barbosa', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Barocas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, College of Public Health, 111 Washington Ave., Lexington, KY, 40536, United States.'}, {'ForeName': 'Jagpreet', 'Initials': 'J', 'LastName': 'Chhatwal', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Boston, MA, 02114, United States.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Harlow', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Ayaz', 'Initials': 'A', 'LastName': 'Hyder', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'University of Miami Miller School of Medicine, 1120 NW 14(th)Street, Suite 1019, Miami, FL, 33136, United States.'}, {'ForeName': 'Jake R', 'Initials': 'JR', 'LastName': 'Morgan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA, 02118, United States.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Savitzky', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Seiber', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'E Starbird', 'Affiliation': 'Columbia University, New York, NY, 10027, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institute on Drug Abuse, 3WFN RM08A45, MSC 6025, 301 North Stonestreet Ave, Rockville, MD, 20852, United States.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108336']
1572,33153517,"Effects of primary care C-reactive protein point-of-care testing on antibiotic prescribing by general practice staff: pragmatic randomised controlled trial, England, 2016 and 2017.","BackgroundC-reactive protein (CRP) testing can be used as a point-of-care test (POCT) to guide antibiotic use for acute cough.AimWe wanted to determine feasibility and effect of introducing CRP POCT in general practices in an area with high antibiotic prescribing for patients with acute cough and to evaluate patients' views of the test.MethodsWe used a McNulty-Zelen cluster pragmatic randomised controlled trial design in general practices in Northern England. Eight intervention practices accepted CRP testing and eight control practices maintained usual practice. Data collection included process evaluation, patient questionnaires, practice audit and antibiotic prescribing data.ResultsEight practices with over 47,000 patient population undertook 268 CRP tests over 6 months: 78% of patients had a CRP < 20 mg/L, 20% CRP 20-100 mg/L and 2% CRP > 100 mg/L, where 90%, 22% and 100%, respectively, followed National Institute for Health and Care Excellence (NICE) antibiotic prescribing guidance. Patients reported that CRP testing was comfortable (88%), convenient (84%), useful (92%) and explained well (85%). Patients believed CRP POCT aided clinical diagnosis, provided quick results and reduced unnecessary antibiotic use. Intervention practices had an estimated 21% reduction (95% confidence interval: 0.46-1.35) in the odds of prescribing for cough compared with the controls, a non-significant but clinically relevant reduction.ConclusionsIn routine general practice, CRP POCT use was variable. Non-significant reductions in antibiotic prescribing may reflect small sample size due to non-use of tests. While CRP POCT may be useful, primary care staff need clearer CRP guidance and action planning according to NICE guidance.",2020,"Intervention practices had an estimated 21% reduction (95% confidence interval: 0.46-1.35) in the odds of prescribing for cough compared with the controls, a non-significant but clinically relevant reduction.","['general practices in Northern England', 'patients with acute cough']","['primary care C-reactive protein point-of-care testing', 'CRP POCT', 'C-reactive protein (CRP']","['CRP testing', 'odds of prescribing for cough']","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742857', 'cui_str': 'Acute cough'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",,0.0504935,"Intervention practices had an estimated 21% reduction (95% confidence interval: 0.46-1.35) in the odds of prescribing for cough compared with the controls, a non-significant but clinically relevant reduction.","[{'ForeName': 'Charlotte Victoria', 'Initials': 'CV', 'LastName': 'Eley', 'Affiliation': 'Primary Care Unit, Public Health England, Gloucester, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'An NHS Clinical Commissioning Group, Greater Manchester, United Kingdom.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'An NHS Clinical Commissioning Group, Greater Manchester, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Charlett', 'Affiliation': 'Statistics Unit, Public Health England, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Owens', 'Affiliation': 'Primary Care Unit, Public Health England, Gloucester, United Kingdom.'}, {'ForeName': 'Cliodna Ann Miriam', 'Initials': 'CAM', 'LastName': 'McNulty', 'Affiliation': 'Primary Care Unit, Public Health England, Gloucester, United Kingdom.'}]",Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin,['10.2807/1560-7917.ES.2020.25.44.1900408']
1573,33154429,Electronic health record alerts enhance mass screening for chronic hepatitis B.,"To measure the effect of an electronic health record (EHR) alert on chronic hepatitis B (CHB) screening among at-risk Asian and Pacific Islanders (API). API patients who had not yet completed hepatitis B surface antigen (HBsAg) testing were identified by a novel EHR-based population health tool. At-risk API patients in Cohort 1 (primarily privately insured) and Cohort 2 (includes Medicare and/or Medicaid) were randomized to alert activation in their electronic medical charts or not. In total, 8299 API were found to be deficient in HBsAg completion at baseline within our health system. In Cohort 1, 1542 patients and 1568 patients were randomized to the alert and control respectively. In Cohort 2, 2599 patients and 2590 patients were randomized to the alert and control respectively. For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09). Our results demonstrate that personalized, automated electronic alerts increase screening for CHB, but more comprehensive measures are needed to detect HBsAg positive patients.NIH Trial Registry Number: NCT04240678.",2020,"For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09).","['At-risk API patients in Cohort 1 (primarily privately insured) and Cohort 2 (includes Medicare and/or Medicaid', '2599 patients and 2590 patients', 'chronic hepatitis B', 'chronic hepatitis B (CHB) screening among at-risk Asian and Pacific Islanders (API', 'API patients who had not yet completed hepatitis B surface antigen ', '1542 patients and 1568 patients']","['electronic health record (EHR) alert', 'Electronic health record alerts enhance mass screening']","['detection of HBsAg positivity', 'HBsAg completion']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242191', 'cui_str': 'Pacific Island Americans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0024870', 'cui_str': 'Mass Screening'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",8299.0,0.0903795,"For both cohorts combined, 389 HBsAg tests were completed in the alert group compared to 177 HBsAg tests in the control group (p < 0.0001; OR = 2.3; 95% CI 1.94-2.80), but there was no increased detection of HBsAg positivity from the alert (15 versus 13 respectively, p = 0.09; OR = 0.5; 95% CI 0.24-1.09).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chak', 'Affiliation': 'Division of Gastroenterology and Hepatology, UC Davis School of Medicine, 4150 V Street, PSSB 3500, Sacramento, CA, USA. echak@ucdavis.edu.'}, {'ForeName': 'Chin-Shang', 'Initials': 'CS', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The State University of New York, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Moon S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology and Oncology, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'MacDonald', 'Affiliation': 'Division of Clinical Informatics, UC Davis Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bowlus', 'Affiliation': 'Division of Gastroenterology and Hepatology, UC Davis School of Medicine, 4150 V Street, PSSB 3500, Sacramento, CA, USA.'}]",Scientific reports,['10.1038/s41598-020-75842-8']
1574,33155562,"""Can patients learn how to reduce their shoulder dislocation?"" A one-year follow-up of the randomized clinical trial between the Boss-Holzach-Matter self-assisted technique and the Spaso method.","OBJECTIVE


The aim of this study was to assess the effectiveness and reproducibility of self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp) method for shoulder dislocation.
METHODS


We conducted a follow-up at 1 year from the randomization of 60 patients with shoulder dislocation enrolled in the study ""Teaching patients to reduce a shoulder dislocation."" Half of these patients had been taught the self-assisted technique, whereas the other half had been treated by a physician's manipulative maneuver for reduction. We surveyed all the enrolled patients to describe recurrence rates and reproducibility for both the techniques without supervision as well as the number of emergency visits.
RESULTS


In total, 52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study. The total rate of recurrence was 38.5% (20 patients). For the Sp group, 4 of the 30 patients were lost. There were 9 recurrent patients (30%), and 7 were treated in the emergency department (ED). For the BHM group, 4 of the 30 patients were lost. There were 11 recurrent patients (37%), and 2 were treated in the ED. The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025).
CONCLUSION


Teaching the BHM technique to the patients is effective and reproducible without direct supervision. It can decrease the number of visits to the ED and is a valid option to teach the patients at risk of recurrence when not being able to get immediate help.
LEVEL OF EVIDENCE


Level I, Therapeutic study.",2020,"The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025).
","['60 patients with shoulder dislocation enrolled in the study ""Teaching patients to reduce a shoulder dislocation', '52 patients (age range: 18-44 years) answered the survey from the 60 patients enrolled in the study']","['self-assisted Boss-Holzach-Matter (BHM) technique compared with the Spaso (Sp', 'Holzach-Matter self-assisted technique and the Spaso method']","['self-reduction rates and ED visits', 'total rate of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037005', 'cui_str': 'Dislocation of shoulder joint'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",60.0,0.0330681,"The difference in self-reduction rates and ED visits for both the groups was statistically significant (p=0.025).
","[{'ForeName': 'Francesc A', 'Initials': 'FA', 'LastName': 'Marcano-Fernández', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Fillat-Gomà', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Balaguer-Castro', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Ona', 'Initials': 'O', 'LastName': 'Ràfols-Perramon', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Serrano-Sanz', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Torner', 'Affiliation': ""Department of Orthopedics, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3Pti, Universitat Autònoma de Barcelona. Sabadell, Spain.""}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19017']
1575,33155565,Assessing the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease.,"OBJECTIVE


The aim of this study was to determine the role of hip arthrography in the treatment decision making for children with Legg-Calvé-Perthes disease (LCPD).
METHODS


A total of 47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study. The patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data were retrospectively collected. The arthrographies were performed immediately before the surgery under general anesthesia. The patients were staged according to the Catterall and Herring classifications and examined in terms of head-at-risk signs before the study. Four sets of patient files were established based on the aforementioned data, with each child in a randomized and blinded order. Ten consultant pediatric orthopedic surgeons randomly assessed the patient files on 4 separate occasions (Set 1 vs Set 2 and Set 3 vs Set 4), with a minimum time interval of 4 weeks. In the first and second sets, the demographic and clinical information, including the age, gender, hip ROM, and hip radiographs, were presented. In the third and fourth sets, hip arthrography was presented in addition to the data from Set 1 and Set 2. The observers were instructed to choose the best treatment options. The percent agreement (PA) and Gwet's AC1 statistics were used to establish a relative level of agreement among the observers.
RESULTS


The mean intra-observer reliabilities ranged from fair to moderate after adding the hip arthrography data (Gwet's AC1 = 0.36 for Set 1 vs Set 2 and 0.42 for Set 3 vs Set 4). The mean PA was 56.6% (range = 29.8% to 78.7%) with a Gwet's AC1 value of 0.51 (range: 0.21 to 0.77) between Set 1 and Set 3 (moderate intra-observer reliability). The decision for the treatment strategy was changed in 43.4% of the patients. For inter-observer reliability, Gwet's AC1 was computed as 0.48 (moderate reliability). The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups. Thus, there is a negative correlation with the disease progression.
CONCLUSION


Hip arthrography seems to have a significant role in the treatment decision making for children with LCPD, especially in the advanced stages of the disease.
LEVEL OF EVIDENCE


Level IV, Therapeutic study.",2020,The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups.,"['47 consecutive children with LCPD (42 boys, 5 girls; mean age=7.5 years; range=6-10 years) who underwent operative treatment were included in the study', 'children with Legg-Calvé-Perthes disease', 'children with Legg-Calvé-Perthes disease (LCPD', 'children with LCPD']",['hip arthrography'],"['patient demographics, physical examination findings (pain and hip range of motion [ROM]), standard anteroposterior and Löwenstein lateral hip radiographs, and hip arthrography data', 'intra-observer reliability and stage progression', 'mean intra-observer reliabilities', 'mean PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",47.0,0.0265941,The correlation between the intra-observer reliability and stage progression was not significant (p>0.05) for any of the subgroups.,"[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Erkuş', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Önder', 'Initials': 'Ö', 'LastName': 'Kalenderer', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Turgut', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tepecik Training and Research Hospital İzmir, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Bacaksız', 'Affiliation': 'Department of Orthopaedics and Traumatology, Akçakale State Hospital Şanlıurfa, Turkey.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Köse', 'Affiliation': 'Department of Orthopaedics and Traumatology, Antalya Training and Research Hospital Antalya, Turkey.'}, {'ForeName': 'Kıvanç', 'Initials': 'K', 'LastName': 'Yüksel', 'Affiliation': 'Department of Data Management and Biostatistics, Ege University, School of Medicine ARGEFAR, İzmir, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19075']
1576,33156201,Alternate Dosing Protocol for Magnesium Sulfate in Obese Women With Preeclampsia: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether obese women need greater doses of magnesium sulfate to obtain therapeutic serum concentrations for eclamptic seizure prevention.
METHODS


Women with preeclampsia and a body mass index (BMI) of 35 or higher were randomly allocated to either the Zuspan regimen of magnesium sulfate (4-g intravenous [IV] loading dose, then a 1-g/h infusion) or to alternate dosing (6-g IV loading dose, then a 2-g/h infusion). Women had serum magnesium concentrations obtained at baseline, as well as after administration of magnesium sulfate at 1 hour, 4 hours, and delivery. The primary outcome was the proportion of women who had subtherapeutic serum magnesium concentrations (less than 4.8 mg/dL) 4 hours after administration. A sample size of 18 women per group was planned to compare the proportion of women with subtherapeutic serum magnesium concentrations in each group.
RESULTS


From July 12, 2016, to March 14, 2019, 89 women with preeclampsia were screened and 37 were enrolled: 18 to the Zuspan regimen and 19 to the alternate regimen. A significantly greater proportion of women administered the Zuspan regimen had subtherapeutic serum magnesium concentrations at 4 hours (100% [95% CI 59-100] vs 63% [95% CI 41-81]; P=.01) compared with women administered the alternate higher dose regimen. At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/dL±0.3 [Zuspan regimen] vs 4.41±0.5 [alternate regimen]; P<.01).
CONCLUSION


The alternate dosing regimen of a 6-g IV loading dose followed by a 2-g/h IV maintenance dose more reliably achieves therapeutic serum magnesium concentrations (as defined by a concentration of at least 4.8 mg/dL) in obese women with preeclampsia.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02835339.",2020,"At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/","['obese women', 'Obese Women With Preeclampsia', 'Women with preeclampsia and a body mass index (BMI) of 35 or higher', 'From July 12, 2016, to March 14, 2019, 89 women with preeclampsia were screened and 37 were enrolled', 'obese women with preeclampsia']","['Zuspan regimen of magnesium sulfate', 'Magnesium Sulfate', 'magnesium sulfate']","['mean concentrations', 'proportion of women who had subtherapeutic serum magnesium concentrations', 'serum magnesium concentrations', 'subtherapeutic serum magnesium concentrations', 'proportion of women with subtherapeutic serum magnesium concentrations', 'therapeutic serum magnesium concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",89.0,0.455186,"At 4 hours, mean concentrations were significantly higher in the alternate regimen group (3.53 mg/","[{'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Brookfield', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon; and the Department of Anesthesia, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Kierstyn', 'Initials': 'K', 'LastName': 'Tuel', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rincon', 'Affiliation': ''}, {'ForeName': 'Abbie', 'Initials': 'A', 'LastName': 'Vinson', 'Affiliation': ''}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': ''}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004137']
1577,33157152,Intranasal oxytocin attenuates insula activity in response to dynamic angry faces.,"The effects of intranasal oxytocin on amygdala activity during emotional perception are often mixed. Given that the brain is organized into networks of interconnected areas, functional connectivity might provide an effective way to further understand the oxytocin effect. The aim of the present study was to investigate whether oxytocin administration affects amygdala activity and its functional connectivity during dynamic facial expression perception. Using a between-group, double-blind, placebo-controlled design, 55 participants were randomly assigned to groups receiving a single dose of 24 IU oxytocin or a placebo via intranasal administration. An implicit emotional task was employed to investigate the effect of oxytocin on neural responses to dynamic angry, neutral, and happy facial expressions with fMRI. Participants were instructed to respond only when the inverted dynamic faces were presented. The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces. However, functional connectivity between the regions involved in the perception of dynamic angry faces was not changed following oxytocin administration. The present findings may contribute to our understanding of the anxiolytic effects of oxytocin and eventually facilitate human clinical applications.",2020,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.",['55 participants'],"['placebo', 'intranasal oxytocin', 'oxytocin', 'Intranasal oxytocin']","['neural responses to dynamic angry, neutral, and happy facial expressions with fMRI', 'activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG', 'amygdala activity']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",55.0,0.160768,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.","[{'ForeName': 'Yuanxiao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China; School of Psychology, Nanjing Normal University, Nanjing, 210024, China.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Ran', 'Affiliation': 'Institute of Education, China West Normal University, Nanchong, 637002, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, 200062, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Wenshuang', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China. Electronic address: chenxu@swu.edu.cn.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107976']
1578,33157498,A double blind randomized controlled trial using copper impregnated maternity sanitary towels to reduce perineal wound infection.,"OBJECTIVE


To investigate the effect of copper impregnated sanitary towels on the infection rate following vaginal delivery (VD).
DESIGN


Single center double blind randomized controlled trial.
PARTICIPANTS


Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD.
INTERVENTIONS


All women were randomized to receive either a copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group).
MAIN OUTCOME MEASURES


The primary study outcome was the incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire. Secondary outcomes were length of hospital stay and risk factors of infection.
RESULTS


450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group. Follow-up rate was 98.2%. A total of 102 women (23.1%) developed an infection within 30 days following VD, 19 in the study group (8.6%) and 83 (37.4%) in the control group (P = <0.001, absolute risk reduction (ARR) of 28.8%). The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = <0.001 and 4.6% vs. 31.5%, P = <0.001 respectively) with an ARR of 22.5% and 27.0% respectively. Multivariable analysis reported Asian ethnicity and prolonged rupture of membranes as significant risk factors; for the development of infection (OR 1.91, P = 0.03 and OR = 1.97, P = 0.04 respectively).
CONCLUSIONS


This is the first study to demonstrate a significant reduction in infection rate following VD with the use of copper impregnated sanitary towels.",2020,"The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = ","['Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD', '450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group']","['copper impregnated maternity sanitary towels', 'copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group']","['incidence of superficial/deep and organ/space infections', 'length of hospital stay and risk factors of infection', 'infection rate', 'perineal wound infection', 'incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0443298', 'cui_str': 'Second degree'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0056598', 'cui_str': 'Cupric oxide'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",450.0,0.323081,"The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = ","[{'ForeName': 'Linda Petra', 'Initials': 'LP', 'LastName': 'Arendsen', 'Affiliation': 'Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, CR7 7YE, United Kingdom.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, CR7 7YE, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, 40 Longwood Lane, Amersham, Bucks, HP7 9EN, United Kingdom.'}, {'ForeName': 'Abdul Hameed', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': ""Obstetrics and Gynaecology Department, Croydon University Hospital, 530 London Road, CR7 7YE, United Kingdom; Honorary Reader, St George's University of London, Cranmer Terrace, SW17 0RE, United Kingdom. Electronic address: abdulsultan@nhs.net.""}]",Midwifery,['10.1016/j.midw.2020.102858']
1579,33157937,Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol.,"INTRODUCTION


Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions.
OBJECTIVE


The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD.
METHODS


This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
DISCUSSION


Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures.
CLINICALTRIALS REGISTRATION NUMBER


NCT04428099.",2020,"The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
","['patients with TRD', '180 patients with TRD', 'treatment-resistant major depression during COVID 19 pandemic']","['Internet-based adjuvant lifestyle-based intervention', 'mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group', 'healthy lifestyle promotion program']","['score on the Beck Depression Inventory-II', 'Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",180.0,0.073809,"The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire.
","[{'ForeName': 'Capilla', 'Initials': 'C', 'LastName': 'Navarro', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Aina M', 'Initials': 'AM', 'LastName': 'Yáñez', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Seguí', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gazquez', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Marino', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ibarra', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Serrano-Ripoll', 'Affiliation': 'Primary Care Research Unit of Majorca, Balearic Islands Health Services and Department of Psychology, University of the Balearic Islands, Palma.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Gomez-Juanes', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Bennasar-Veny', 'Affiliation': 'Department of Nursing and Physiotherapy and Research Group on Global Health and Human Development.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Salva', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Oliván', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza and Preventive Activities and Health Promotion Network, REDIAPP (G06/170), Zaragoza, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Garcia-Toro', 'Affiliation': 'Research Institute of Health Sciences (IUNICS-IDISBA).'}]",Medicine,['10.1097/MD.0000000000022958']
1580,33158419,Feasibility and success rates of response enhancing strategies in a stepwise prevention program for cardiometabolic diseases in primary care.,"BACKGROUND


Prevention programs for cardiometabolic diseases (CMD), including cardiovascular disease, diabetes mellitus and chronic kidney disease are feasible, but evidence for the cost-effectiveness of selective CMD prevention programs is lacking. Response rates have an important role in effectiveness, but methods to increase response rates have received insufficient attention. The aim of the current study is to determine the feasibility and the success rate of a variety of response enhancing strategies to increase the participation in a selective prevention program for CMD.
METHODS


The INTEGRATE study is a Dutch randomised controlled trial to assess the effectiveness and cost-effectiveness of a stepwise program for CMD prevention. During the INTEGRATE study we developed ten different response enhancing strategies targeted at different stages of non-response and different patient populations and evaluated these in 29 general practices.
RESULTS


A face-to-face reminder by the GP increased the response significantly. Digital reminders targeted at patients with an increased CMD risk showed a positive trend towards participation. Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination. Translated materials, information gatherings at the practice, self-management toolkits, reminders by telephone, information letters, local media attention and SMS text reminders did not increase the response to our program.
CONCLUSIONS


Inviting or reminding patients by e-mail or during GPs consultation may enhance response rates in a selective prevention program for CMD. Different response-enhancing strategies have different patient target populations and implementation issues, therefore practice characteristics need to be taken into account when implementing such strategies.
TRIAL REGISTRATION


Dutch trial Register number NTR4277 . Registered 26 November 2013.",2020,"Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination.",['cardiometabolic diseases in primary care'],[],['effectiveness and cost-effectiveness'],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0344832,"Sending invitations and reminders by e-mail generated similar response rates, but at lower costs and time investment than the standard way of dissemination.","[{'ForeName': 'Ilse F', 'Initials': 'IF', 'LastName': 'Badenbroek', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands. I.F.Badenbroek@umcutrecht.nl.'}, {'ForeName': 'Marcus M J', 'Initials': 'MMJ', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hollander', 'Affiliation': 'JULIUS CENTER FOR HEALTH SCIENCES AND PRIMARY CARE, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Daphne M', 'Initials': 'DM', 'LastName': 'Stol', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands.'}, {'ForeName': 'Roderik A', 'Initials': 'RA', 'LastName': 'Kraaijenhagen', 'Affiliation': 'NDDO Institute for Prevention and Early Diagnostics (NIPED), Naritaweg 70, 1043, BZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Niek J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'JULIUS CENTER FOR HEALTH SCIENCES AND PRIMARY CARE, University Medical Center Utrecht, P.O. Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'François G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Netherlands Institute for Health Services Research (NIVEL), P.O. Box 1568, 3500, BN, Utrecht, the Netherlands.'}]",BMC family practice,['10.1186/s12875-020-01293-9']
1581,33158422,"Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial.","BACKGROUND


Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions.
METHODS/DESIGN


This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish ""Prescribe Vida Saludable"") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time.
DISCUSSION


The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system.
TRIAL REGISTRATION


NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.",2020,There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions.,"['370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia', 'patients with chronic conditions', 'people with chronic diseases', 'across people with different chronic conditions']","['standard healthy life prescription (PVS', 'physical exercise', 'physical exercise programme', 'EfiKroniK group will be prescribed a physical exercise programme']","['cardiorespiratory functional capacity and quality of life', 'signs and symptoms, psychological and social factors and specific laboratory parameters', 'cardiorespiratory capacity and quality of life']","[{'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0337460', 'cui_str': 'Social factor'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0676886,There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions.,"[{'ForeName': 'María Soledad', 'Initials': 'MS', 'LastName': 'Arietaleanizbeaskoa', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain. MARIASOLEDAD.ARIETALEANIZBEASKOASARABIA@osakidetza.eus.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'Sancho', 'Affiliation': 'Medical Oncology Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Olazabal', 'Affiliation': 'Medical Hematology Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Concepcion', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Medical Mental Health Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Erreka', 'Initials': 'E', 'LastName': 'Gil', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Garcia-Alvarez', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Nere', 'Initials': 'N', 'LastName': 'Mendizabal', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Ibon', 'Initials': 'I', 'LastName': 'de la Fuente', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Dominguez', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Pablo', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Grandes', 'Affiliation': 'Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01298-4']
1582,33158424,Correction to: Integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['patients with persistent physical symptoms'],['Integrated GP care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],,0.0446675,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'UK South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, Maple House, UCL Institute of Mental Health, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': 'Institute for Lifecourse Development, University of Greenwich, Old Royal Naval College, Park Row, Greenwich, London, SE10 9LS, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01302-x']
1583,33159348,Comment on 'Preoperative intravenous iron therapy and survival after colorectal cancer surgery: long-term results from the IVICA randomized controlled trial'.,,2020,The original randomised controlled trial in 116 patients found no significant difference in postoperative blood transfusion requirement between the two methods of iron replacement in anaemic patients undergoing surgery for stage I-III disease [2].,"['patients undergoing surgery for colorectal cancer (CRC) [1', 'Colorectal Cancer Surgery', '116 patients', 'anaemic patients undergoing surgery for stage I-III disease [2']",['parenteral iron to oral iron'],['postoperative blood transfusion requirement'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0444624', 'cui_str': 'Iron-containing product in parenteral dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",116.0,0.246042,The original randomised controlled trial in 116 patients found no significant difference in postoperative blood transfusion requirement between the two methods of iron replacement in anaemic patients undergoing surgery for stage I-III disease [2].,"[{'ForeName': 'Stephen Thomas', 'Initials': 'ST', 'LastName': 'McSorley', 'Affiliation': 'Academic Unit of Surgery, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Colin W', 'Initials': 'CW', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Surgery, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Anderson', 'Affiliation': 'Department of Coloproctology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'McKinlay', 'Affiliation': 'Department of Anaesthetics and Perioperative Care, Glasgow Royal Infirmary, Glasgow, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15428']
1584,33136058,Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin in the Treatment of Severe Pneumonia in Children Aged 2 to 59 Months: Protocol for an Open-Label Randomized Controlled Trial.,"BACKGROUND


Pneumonia causes about 0.9 million deaths worldwide each year. The World Health Organization (WHO) guidelines for the standard management of severe pneumonia requires parenteral ampicillin every 6 hours and once-daily parenteral gentamicin for 5 to 7 days. Although this treatment has contributed to the reduction of mortality, it requires nursing interventions every 6 hours for 7 days. Further intervention trials should be conducted to search for alternate antibiotics with better adherence, reduced cost, and reduced hospital stay. Parenteral amoxicillin is an effective alternative to ampicillin, as it has a longer half-life and broader coverage.
OBJECTIVE


The aim of this clinical trial is to compare the efficacy of a dose of injectable amoxicillin every 12 hours plus a once-daily dose of injectable gentamicin with a dose of injectable ampicillin every 6 hours plus a once-daily dose of injectable gentamicin in children hospitalized for severe pneumonia.
METHODS


This randomized, controlled, open-label, noninferiority trial is being conducted in Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh. A sample size of 308 children with severe pneumonia will give adequate power to this study. Children aged 2 to 59 months are randomized to either intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin in both study arms. The monitoring of the patients is carried out according to the WHO protocol for the treatment of severe pneumonia. The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy. The secondary objectives are (1) improvement in or the resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections.
RESULTS


Enrollment in the study started on January 1, 2018, and ended on October 31, 2019. Data entry and analysis are in progress. Findings from the study are expected to be disseminated in October 2020.
CONCLUSIONS


Our study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17735.",2020,"The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy.","['308 children with severe pneumonia', 'children hospitalized for severe pneumonia', 'Severe Pneumonia in Children', 'Children aged 2 to 59 months', 'Enrollment in the study started on January 1, 2018, and ended on October 31, 2019']","['Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin', 'intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin', 'injectable gentamicin', 'Parenteral amoxicillin', 'injectable amoxicillin', 'gentamicin']","['resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections', 'rate of treatment failure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}]",308.0,0.16116,"The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy.","[{'ForeName': 'Lubaba', 'Initials': 'L', 'LastName': 'Shahrin', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammod Jobayer', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Abu Sadat Mohammad Sayeem Bin', 'Initials': 'ASMSB', 'LastName': 'Shahid', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Abu Sayem Mirza Mohammad Hasibur', 'Initials': 'ASMMH', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Md Zahidul', 'Initials': 'MZ', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Afroze', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Sayeeda', 'Initials': 'S', 'LastName': 'Huq', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}]",JMIR research protocols,['10.2196/17735']
1585,33136059,Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.,"BACKGROUND


Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals.
OBJECTIVE


This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care.
METHODS


The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both. In the intervention for patients, participants received an educational group program and were monitored and supported by logs, a web-based platform, and automated SMS. Those in the intervention for professionals also received an educational program, a decision support tool embedded in the electronic clinical record, and periodic feedback about patients' results. A total of 2334 people with T2DM, regardless of glycated hemoglobin (HbA 1c ) levels and without diabetes-related complications, were included. The primary end point was change in HbA 1c  level. The main analysis was performed using multilevel mixed models.
RESULTS


For the overall sample, the intervention for patients attained a significant mean reduction in HbA 1c  levels of ‒0.27 (95% CI ‒0.45 to ‒0.10) at month 3 and ‒0.26 (95% CI ‒0.44 to ‒0.08) at month 6 compared with usual care, which remained marginally significant at month 12. A clinically relevant reduction in HbA 1c  level was observed in 35.6% (191/537) of patients in the intervention for patients and 26.0% (152/586) of those in usual care at month 12 (P=.006). In the combined intervention, HbA 1c  reduction was significant until month 18 (181/557, 32.6% vs 140/586, 23.9%; P=.009). Considering the subgroup of patients uncontrolled at baseline, all interventions produced significant reductions in HbA 1c  levels across the entire study period: ‒0.49 (95% CI ‒0.70 to ‒0.27) for the intervention for patients, ‒0.35 (95% CI ‒0.59 to ‒0.14) for the intervention for professionals, and ‒0.35 (95% CI ‒0.57 to ‒0.13) for the combined intervention. Differences in HbA 1c  for the area under the curve considering the entire period were significant for the intervention for patients and the combined intervention compared with usual care (P=.03 for both). Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.
CONCLUSIONS


In uncontrolled patients, the intervention for patients at baseline provided clinically relevant and significant longer-term reductions of HbA 1c  levels. The intervention for professionals and combined intervention also improved the cardiovascular risk profile of patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227.",2020,"Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.
","['patients with T2DM in primary care', 'Type 2 Diabetes', '2334 people with T2DM, regardless of glycated hemoglobin (HbA 1c ) levels and without diabetes-related complications, were included', 'Patients and Health Care Professionals']","['Internet-Based Multicomponent Interventions', 'internet-based multicomponent interventions']","['systolic and diastolic blood pressure', 'cardiovascular risk profile', 'change in HbA 1c  level', 'HbA 1c  level', 'HbA 1c  levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",2334.0,0.112916,"Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.
","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ramallo-Fariña', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Bello', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'García-Pérez', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Boronat', 'Affiliation': 'Department of Endocrinology and Nutrition, Insular University Hospital, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Wägner', 'Affiliation': 'Department of Endocrinology and Nutrition, Insular University Hospital, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de Pablos-Velasco', 'Affiliation': 'University Institute for Biomedical and Health Research (IUIBS), University of Las Palmas de Gran Canaria (ULPG), Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Llorente Gómez de Segura', 'Affiliation': 'Department of Endocrinology and Nutrition, Nuestra Señora de la Candelaria University Hospital, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Himar', 'Initials': 'H', 'LastName': 'González-Pacheco', 'Affiliation': 'Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Carmona Rodríguez', 'Affiliation': 'Research Network on Health Services in Chronic Diseases (REDISSEC), Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Serrano-Aguilar', 'Affiliation': 'Research Network on Health Services in Chronic Diseases (REDISSEC), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'See Author´s Contributions Section, Santa Cruz de Tenerife, Spain.'}]",JMIR mHealth and uHealth,['10.2196/18922']
1586,33137100,"Baseline patterns of infection in regions of Benin, Malawi and India seeking to interrupt transmission of soil transmitted helminths (STH) in the DeWorm3 trial.","Global efforts to control morbidity associated with soil-transmitted helminth infections (STH) have focused largely on the targeted treatment of high-risk groups, including children and pregnant women. However, it is not clear when such programs can be discontinued and there are concerns about the sustainability of current STH control programs. The DeWorm3 project is a large multi-country community cluster randomized trial in Benin, India and Malawi designed to determine the feasibility of interrupting the transmission of STH using community-wide delivery of mass drug administration (MDA) with anthelmintics over multiple rounds. Here, we present baseline data and estimate key epidemiological parameters important in determining the likelihood of transmission interruption in the DeWorm3 trial. A baseline census was conducted in October-December 2017 in India, November-December 2017 in Malawi and in January-February 2018 in Benin. The baseline census enumerated all members of each household and collected demographic data and information on occupation, assets, and access to water, sanitation and hygiene (WASH). Each study site was divided into 40 clusters of at least 1,650 individuals per cluster. Clusters were randomized to receive twice yearly community-wide MDA with albendazole (GSK) targeting eligible individuals of all ages (20 clusters), or to receive the standard-of-care deworming program targeting children provided in each country. In each site, a randomly selected group of 150 individuals per cluster (6,000 total per site) was selected from the baseline census using stratified random sampling, and each individual provided a single stool sample for analysis of STH infection using the Kato-Katz technique. Study site, household and individual characteristics were summarized as appropriate. We estimated key epidemiological parameters including the force of infection and the degree of parasite aggregation within the population. The DeWorm3 sites range in population from 94,969 to 140,932. The population age distribution varied significantly by site, with the highest proportion of infants and young children in Malawi and the highest proportion of adults in India. The baseline age- and cluster-weighted prevalence, as measured by Kato-Katz, varied across sites and by species, Baseline hookworm prevalence in India was 21.4% (95% CI: 20.4-22.4%), while prevalence of Ascaris and Trichuris by Kato-Katz was low (0.1% and 0.3% overall). In Malawi, the overall age- and cluster-weighted STH prevalence was 7.7% (95% CI: 7.1-8.4%) predominantly driven by hookworm infections (7.4%) while Ascaris (0.1%) and Trichuris (0.3%) infections were rare. In Benin, the overall age- and cluster-weighted prevalence was significantly lower (5.6%, 95% CI: 5.1-6.2%) and Ascaris (2.0%, 95% CI: 1.6-2.3%) was more common than in other sites. Ascaris infections were more likely to be moderate- or heavy-intensity (43.7%, unweighted) compared to hookworm (5.0%). The force of infection for hookworm was highest in adults in India and Malawi but appeared relatively stable across age groups in Benin. These data demonstrate the significant variability between the sites in terms of demography, socio-economic status and environmental characteristics. In addition, the baseline prevalence and intensity data from DeWorm3 suggest that each site has unique epidemiologic characteristics that will be critical in determining correlates of achieving STH transmission interruption in the DeWorm3 trial. Trial registration: The trial was registered at ClinicalTrials.gov (NCT03014167).",2020,The force of infection for hookworm was highest in adults in India and Malawi but appeared relatively stable across age groups in Benin.,"['October-December 2017 in India, November-December 2017 in Malawi and in January-February 2018 in Benin', 'Each study site was divided into 40 clusters of at least 1,650 individuals per cluster', 'children and pregnant women']","['albendazole (GSK', 'standard-of-care deworming program targeting children provided in each country']","['Ascaris infections', 'prevalence of Ascaris and Trichuris by Kato-Katz', 'demographic data and information on occupation, assets, and access to water, sanitation and hygiene (WASH', 'hookworm infections', 'overall age- and cluster-weighted STH prevalence', 'overall age- and cluster-weighted prevalence', 'force of infection for hookworm', 'Ascaris']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199859', 'cui_str': 'Deworming'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0003950', 'cui_str': 'Ascariasis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0003954', 'cui_str': 'Ascaris'}, {'cui': 'C0040955', 'cui_str': 'Trichuris'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0019911', 'cui_str': 'Disease due to superfamily Ancylostomatoidea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002830', 'cui_str': 'Superfamily ancylostomatoidea'}]",,0.128256,The force of infection for hookworm was highest in adults in India and Malawi but appeared relatively stable across age groups in Benin.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008771']
1587,33137378,Pioglitazone corrects dysregulation of skeletal muscle mitochondrial proteins involved in ATP synthesis in type 2 diabetes.,"CONTEXT


In this study, we aimed to identify the determinants of mitochondrial dysfunction in skeletal muscle (SKLM) of subjects with type 2 diabetes (T2DM), and to evaluate the effect of pioglitazone (PIO) on SKLM mitochondrial proteome.
METHODS


Two different groups of adults were studied. Group I consisted of 8 individuals with normal glucose tolerance (NGT) and 8 with T2DM, subjected to SKLM mitochondrial proteome analysis by 2D-gel electrophoresis followed by mass spectrometry-based protein identification. Group II included 24 individuals with NGT and 24 with T2DM, whose SKLM biopsies were subjected to immunoblot analysis. Of the 24 subjects with T2DM, 20 were randomized to receive placebo or PIO (15 mg daily) for 6 months. After 6 months of treatment, SKLM biopsy was repeated.
RESULTS


Mitochondrial proteomic analysis on Group I revealed that several mitochondrial proteins involved in oxidative metabolism were differentially expressed between T2DM and NGT groups, with a downregulation of ATP synthase alpha chain (ATP5A), electron transfer flavoprotein alpha-subunit (ETFA), cytochrome c oxidase subunit VIb isoform 1 (CX6B1), pyruvate dehydrogenase protein X component (ODPX), dihydrolipoamide dehydrogenase (DLDH), dihydrolipoamide-S-succinyltransferase (DLST), and mitofilin, and an up-regulation of hydroxyacyl-CoA-dehydrogenase (HCDH), 3,2-trans-enoyl-CoA-isomerase (D3D2) and delta3,5-delta2,4-dienoyl-CoA-isomerase (ECH1) in T2DM as compared to NGT subjects. By immunoblot analysis on SKLM lysates obtained from Group II we confirmed that, in comparison to NGT subjects, those with T2DM exhibited lower protein levels of ATP5A (-30%, P = 0.006), ETFA (-50%, P = 0.02), CX6B1 (-30%, P = 0.03), key factors for ATP biosynthesis, and of the structural protein mitofilin (-30%, P = 0.01). T2DM was associated with a reduced abundance of the enzymes involved in the Krebs cycle DLST and ODPX (-20%, P ≤ 0.05) and increased levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism (+30%, P ≤ 0.05). In subjects with type 2 diabetes treated with PIO for 6 months we found a restored SKLM protein abundance of ATP5A, ETFA, CX6B1, and mitofilin. Moreover, protein levels of HCDH and ECH1 were reduced by -10% and - 15% respectively (P ≤ 0.05 for both) after PIO treatment.
CONCLUSION


Type 2 diabetes is associated with reduced levels of mitochondrial proteins involved in oxidative phosphorylation and an increased abundance of enzymes implicated in fatty acid catabolism in SKLM. PIO treatment is able to improve SKLM mitochondrial proteomic profile in subjects with T2DM.",2020,"T2DM was associated with a reduced abundance of the enzymes involved in the Krebs cycle DLST and ODPX (-20%, P≤0.05) and increased levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism (+30%, P≤0.05).","['subjects with type 2 diabetes (T2DM', 'Group II included 24 individuals with NGT and 24 with T2DM, whose SKLM biopsies', '24 subjects with T2DM, 20', 'subjects with T2DM']","['pioglitazone (PIO', 'Pioglitazone', 'normal glucose tolerance (NGT) and 8 with T2DM, subjected to SKLM mitochondrial proteome analysis by 2D-gel electrophoresis followed by mass spectrometry-based protein identification', 'placebo or PIO']","['restored SKLM protein abundance of ATP5A, ETFA, CX6B1, and mitofilin', 'oxidative metabolism', 'ATP synthase alpha chain (ATP5A), electron transfer flavoprotein alpha-subunit (ETFA), cytochrome c oxidase subunit VIb isoform 1 (CX6B1), pyruvate dehydrogenase protein X component (ODPX), dihydrolipoamide dehydrogenase (DLDH), dihydrolipoamide-S-succinyltransferase (DLST), and mitofilin', 'protein levels of ATP5A', 'ETFA', 'levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism', 'CX6B1', 'protein levels of HCDH and ECH1']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C2315740', 'cui_str': 'Biopsy of skeletal muscle'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0860800', 'cui_str': 'Glucose normal'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0751973', 'cui_str': 'Proteomes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013860', 'cui_str': 'Electrophoresis, Gel, Two Dimensional'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1568849', 'cui_str': 'ETFA protein, human'}, {'cui': 'C0282636', 'cui_str': 'Respiration, Cell'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0072792', 'cui_str': 'Pyruvate dehydrogenase (lipoamide)'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023783', 'cui_str': 'Dihydrolipoamide dehydrogenase'}, {'cui': 'C0058086', 'cui_str': 'dihydrolipoamide'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}]",8.0,0.039439,"T2DM was associated with a reduced abundance of the enzymes involved in the Krebs cycle DLST and ODPX (-20%, P≤0.05) and increased levels of HCDH and ECH1, enzymes implicated in the fatty acid catabolism (+30%, P≤0.05).","[{'ForeName': 'Teresa Vanessa', 'Initials': 'TV', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy; Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Monroy', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America; Oncology, General Hospital of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Subash', 'Initials': 'S', 'LastName': 'Kamath', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Sotero', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Michele Dei', 'Initials': 'MD', 'LastName': 'Cas', 'Affiliation': 'Clinical Biochemistry and Mass Spectrometry Laboratory, Department of Health Science, University of Milan, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America.'}, {'ForeName': 'Alberto O', 'Initials': 'AO', 'LastName': 'Chavez', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America.'}, {'ForeName': 'Marta Letizia', 'Initials': 'ML', 'LastName': 'Hribal', 'Affiliation': 'Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Clinical and Molecular Medicine, University of Rome-Sapienza, Rome, Italy.'}, {'ForeName': 'Devjit', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Folli', 'Affiliation': 'Division of Diabetes, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States of America; Endocrinology and Metabolism, Department of Health Science, University of Milan, Diabetologia e Malattie Metaboliche, Aziende Socio Sanitarie Territoriali Santi Paolo e Carlo, Milan, Italy. Electronic address: franco.folli@unimi.it.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154416']
1588,33137489,"Exercise mitigates sleep loss-induced changes in glucose tolerance, mitochondrial function, sarcoplasmic protein synthesis, and diurnal rhythms.","OBJECTIVE


Sleep loss has emerged as a risk factor for the development of impaired glucose tolerance. The mechanisms underpinning this observation are unknown; however, both mitochondrial dysfunction and circadian misalignment have been proposed. Because exercise improves glucose tolerance and mitochondrial function, and alters circadian rhythms, we investigated whether exercise may counteract the effects induced by inadequate sleep.
METHODS


To minimize between-group differences of baseline characteristics, 24 healthy young males were allocated into one of the three experimental groups: a Normal Sleep (NS) group (8 h time in bed (TIB) per night, for five nights), a Sleep Restriction (SR) group (4 h TIB per night, for five nights), and a Sleep Restriction and Exercise group (SR+EX) (4 h TIB per night, for five nights and three high-intensity interval exercise (HIIE) sessions). Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature were assessed pre- and post-intervention.
RESULTS


We report that the SR group had reduced glucose tolerance post-intervention (mean change ± SD, P value, SR glucose AUC: 149 ± 115 A.U., P = 0.002), which was also associated with reduction in mitochondrial respiratory function (SR: -15.9 ± 12.4 pmol O 2 .s -1 .mg -1 , P = 0.001), a lower rate of SarcPS (FSR%/day SR: 1.11 ± 0.25%, P < 0.001), and reduced amplitude of diurnal rhythms. These effects were not observed when incorporating three sessions of HIIE during this period (SR+EX: glucose AUC 67 ± 57, P = 0.239, mitochondrial respiratory function: 0.6 ± 11.8 pmol O 2 .s -1 .mg -1 , P = 0.997, and SarcPS (FSR%/day): 1.77 ± 0.22%, P = 0.971).
CONCLUSIONS


A five-night period of sleep restriction leads to reduction in mitochondrial respiratory function, SarcPS, and amplitude of skin temperature diurnal rhythms, with concurrent reduction in glucose tolerance. We provide novel data demonstrating that these same detrimental effects are not observed when HIIE is performed during the period of sleep restriction. These data therefore provide evidence in support of the use of HIIE as an intervention to mitigate the detrimental physiological effects of sleep loss.",2020,"Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature were assessed pre- and post-intervention.
",['24 healthy young males'],"['SarcPS', 'Normal Sleep (NS) group (8 h time in bed (TIB) per night, for five nights), a Sleep Restriction (SR) group (4 h TIB per night, for five nights), and a Sleep Restriction and Exercise group (SR+EX) (4 h TIB per night, for five nights and three high-intensity interval exercise (HIIE) sessions']","['lower rate of SarcPS', 'Exercise mitigates sleep-loss-induced changes in glucose tolerance, mitochondrial function, sarcoplasmic protein synthesis, and diurnal rhythms', 'reduced glucose tolerance', 'Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature', 'amplitude of diurnal rhythms', 'glucose tolerance, mitochondrial function, and alters circadian rhythms', 'mitochondrial respiratory function, SarcPS, and amplitude of skin temperature diurnal rhythms', 'glucose tolerance', 'mitochondrial respiratory function']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0235161', 'cui_str': 'Sleep loss'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",24.0,0.0375417,"Glucose tolerance, mitochondrial respiratory function, sarcoplasmic protein synthesis (SarcPS), and diurnal measures of peripheral skin temperature were assessed pre- and post-intervention.
","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Saner', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia; Sports Cardiology, Baker Heart and Diabetes Institute, Melbourne, Australia. Electronic address: nicholas.saner@live.vu.edu.au.'}, {'ForeName': 'Matthew J-C', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Jujiao', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Nathan W', 'Initials': 'NW', 'LastName': 'Pitchford', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia; Sport Performance Optimization Research Team, School of Human Life Sciences, University of Tasmania, Launceston, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Roach', 'Affiliation': 'Appleton Institute for Behavioral Science, Central Queensland University, Adelaide, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Garnham', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Genders', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Tanner', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Schroder', 'Affiliation': 'Department of Physiology, College of Medicine, University of Kentucky, Lexington, United States.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Karyn A', 'Initials': 'KA', 'LastName': 'Esser', 'Affiliation': 'Department of Physiology and Functional Genomics, University of Florida, Gainesville, United States.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia. Electronic address: david.bishop@vu.edu.au.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Bartlett', 'Affiliation': 'Institute for Health and Sport, Victoria University, Melbourne, Australia.'}]",Molecular metabolism,['10.1016/j.molmet.2020.101110']
1589,33138628,Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.,"Background:  The VOYAGER PAD trial demonstrated superiority of rivaroxaban plus aspirin versus aspirin to reduce major cardiac and ischemic limb events following lower extremity revascularization (LER). Clopidogrel is commonly used as a short-term adjunct to aspirin after endovascular revascularization, whether clopidogrel modifies the efficacy and safety of rivaroxaban has not been described.  Methods:  VOYAGER PAD was a phase 3, international, double-blind, placebo-controlled trial in symptomatic PAD patients undergoing LER randomized to rivaroxaban 2.5 mg twice daily plus 100 mg aspirin daily or rivaroxaban placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke or cardiovascular death. The principal safety endpoint was TIMI major bleeding with ISTH major bleeding a secondary safety outcome. Clopidogrel use was allowed at the discretion of the investigator for up to six months following the qualifying revascularization.  Results:  3313 (50.6%) of the randomized patients received clopidogrel, median duration of 29.0 days. Over 3-years the hazard ratio (HR) for the primary outcome of rivaroxaban versus placebo was 0.85 (95% CI 0.71-1.01) with clopidogrel and 0.86 (95% CI 0.73-1.01) without, without statistical heterogeneity (p-interaction =0.92). Rivaroxaban resulted in an early apparent reduction in acute limb ischemia (ALI) within 30 days, HR 0.45 (95%CI 0.14-1.46) with and HR 0.48 (95% CI 0.22-1.01) without clopidogrel (p-interaction = 0.93). Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (p-interaction 0.71). With clopidogrel use >30 days, rivaroxaban was associated with more ISTH major bleeding within 365 days (HR 3.20, 95% CI 1.44-7.13) compared with shorter durations of clopidogrel (p-trend 0.06).  Conclusions:  In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for ALI regardless of clopidogrel use. The safety of rivaroxaban was consistent regardless of clopidogrel use, but with a trend for more ISTH major bleeding with clopidogrel use > 30 days than a shorter duration. These data support the addition of rivaroxaban to aspirin after LER regardless of concomitant clopidogrel with a short (course ≤ 30 days) associated with less bleeding.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT02504216.",2020,"Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (p-interaction 0.71).","['lower extremity revascularization (LER', 'Peripheral Artery Disease Lower Extremity Revascularization', 'symptomatic PAD patients undergoing LER randomized to']","['rivaroxaban', 'rivaroxaban plus aspirin versus aspirin', 'Clopidogrel', 'Rivaroxaban', 'rivaroxaban plus aspirin', 'Rivaroxaban and Aspirin', 'placebo', 'clopidogrel', 'aspirin, rivaroxaban', 'aspirin daily or rivaroxaban placebo plus aspirin']","['TIMI major bleeding with ISTH major bleeding a secondary safety outcome', 'risk of adverse cardiovascular and limb events', 'major cardiac and ischemic limb events', 'composite of acute limb ischemia, major amputation of a vascular cause, myocardial infarction, ischemic stroke or cardiovascular death', 'Efficacy and Safety', 'ISTH major bleeding', 'TIMI major bleeding', 'hazard ratio (HR', 'acute limb ischemia (ALI', 'bleeding']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242488', 'cui_str': 'Acute lung injury'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.550696,"Compared with aspirin, rivaroxaban increased TIMI major bleeding similarly regardless of clopidogrel use (p-interaction 0.71).","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Department of Surgery, Aurora, CO.'}, {'ForeName': 'Eike Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'Department of Vascular Medicine, Vascular Surgery - Angiology - Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Population Health Research Institute, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'CPC Clinical Research, Aurora, CO; Department of Medicine, Division of Endocrinology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Brackin', 'Affiliation': 'CPC Clinical Research, Aurora, CO.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jaeger', 'Affiliation': 'CPC Clinical Research, Aurora, CO.'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'CPC Clinical Research, Aurora, CO; University of Colorado School of Medicine, Division of Cardiology, Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'Bayer AG, Research & Development, Wuppertal, Germany.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer US LLC, Whippany, NJ.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'Bayer AG, Research & Development, Wuppertal, Germany.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Haskell', 'Affiliation': 'Janssen Research and Development, Raritan, NJ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brasil', 'Affiliation': 'FELUMA - Faculdade de Ciencias Medicas de Minas Gerais School of Medicine, Belo Horizonte, Brasil.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Madaric', 'Affiliation': 'Department of Angiology, Comenius University and National Cardiovascular Institute, Bratislava, Slovakia.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Sillesen', 'Affiliation': 'Dept. of Vascular Surgery, Rigshospitalet, Institute of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Szalay', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050465']
1590,33138740,Right To Play's intervention to reduce peer violence among children in public schools in Pakistan: a cluster-randomized controlled trial.,"BACKGROUND


Peer violence is common globally, but a little researched topic in low-and middle-income countries. This study presents the evaluation of a two-year randomized controlled trial of a structured play-based life-skills intervention implemented in schools in Hyderabad, Pakistan.
OBJECTIVE


To determine the impact of the intervention on school-based peer violence (victimization and perpetration) and depression among school children.
METHODS


40 single-sex public schools were randomized into two study arms (20 per arm 10 of each sex). A total of 1752 grade 6 students (929 from intervention and 823 from control schools) were enrolled in the trial. The two-year intervention was a biweekly structured game led by a coach followed by critical reflection and discussion for 30 minutes. Primary outcomes (exposure to peer violence exhibited through victimization and perpetration and depression) were evaluated using generalized linear-mixed models.
RESULTS


Of the enrolled children (N = 1752) 91% provided data for analysis. There were significant decreases in self-reported peer violence victimization, perpetration and depression. For peer violence victimization, the reductions in the intervention and control arms were: 33.3% versus 27.8% for boys and 58.5% versus 21.3% for girls. For peer violence perpetration, the reductions were: 25.3% versus 11.1% for boys and 55.6% versus 27.6% for girls in the intervention and control arms, respectively. There were significant drops in mean depression scores (boys 7.2% versus 4.8% intervention and control and girls 9.5% versus 5.6% intervention and control).
CONCLUSION


A well-designed and implemented play-based life-skills intervention delivered in public schools in Pakistan is able to effect a significant reduction in peer violence.",2020,"For peer violence perpetration, the reductions were: 25.3% versus 11.1% for boys and 55.6% versus 27.6% for girls in the intervention and control arms, respectively.","['40 single-sex public schools', 'children in public schools in Pakistan', 'Of the enrolled children (N\xa0', 'schools in Hyderabad, Pakistan', 'school children', 'A total of 1752 grade 6 students (929 from intervention and 823 from control schools']","['structured play-based life-skills intervention', 'biweekly structured game led by a coach followed by critical reflection and discussion for 30\xa0minutes']","['peer violence exhibited through victimization and perpetration and depression', 'mean depression scores', 'school-based peer violence (victimization and perpetration) and depression', 'self-reported peer violence victimization, perpetration and depression', 'peer violence']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.076969,"For peer violence perpetration, the reductions were: 25.3% versus 11.1% for boys and 55.6% versus 27.6% for girls in the intervention and control arms, respectively.","[{'ForeName': 'Rozina', 'Initials': 'R', 'LastName': 'Karmaliani', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'McFarlane', 'Affiliation': ""College of Nursing, Texas Woman's University , Denton, TX, USA.""}, {'ForeName': 'Hussain Maqbool Ahmed', 'Initials': 'HMA', 'LastName': 'Khuwaja', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Somani', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Shireen', 'Initials': 'S', 'LastName': 'Shehzad', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Tazeen', 'Initials': 'T', 'LastName': 'Saeed Ali', 'Affiliation': 'School of Nursing and Midwifery, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Nargis', 'Initials': 'N', 'LastName': 'Asad', 'Affiliation': 'Department of Psychiatry, Aga Khan University , Karachi City, Pakistan.'}, {'ForeName': 'Esnat D', 'Initials': 'ED', 'LastName': 'Chirwa', 'Affiliation': 'Gender & Health Research Unit, South Africa Medical Research Council , Pretoria, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender & Health Research Unit, South Africa Medical Research Council , Pretoria, South Africa.'}]",Global health action,['10.1080/16549716.2020.1836604']
1591,33139537,Antibody-mediated activation of the FGFR1/Klothoβ complex corrects metabolic dysfunction and alters food preference in obese humans.,"Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ (FGFR1/KLB) complexes expressed in adipocytes, pancreatic acinar cells, and the nervous system in mice. Chronic administration of recombinant FGF21 or engineered variants improves metabolic health in rodents, nonhuman primates, and humans; however, the rapid turnover of these molecules limits therapeutic utility. Here we show that the bispecific anti-FGFR1/KLB agonist antibody BFKB8488A induced marked weight loss in obese cynomolgus monkeys while elevating serum adiponectin and the adipose expression of FGFR1 target genes, demonstrating its action as an FGF21 mimetic. In a randomized, placebo-controlled, single ascending-dose study in overweight/obese human participants, subcutaneous BFKB8488A injection caused transient body weight reduction, sustained improvement in cardiometabolic parameters, and a trend toward reduction in preference for sweet taste and carbohydrate intake. These data suggest that specific activation of the FGFR1/KLB complex in humans can be used as therapy for obesity-related metabolic defects.",2020,Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ,"['obese humans', 'overweight/obese human participants']","['subcutaneous BFKB8488A injection', 'placebo', 'FGFR1/Klothoβ complex', 'recombinant FGF21', 'bispecific anti-FGFR1/KLB agonist antibody BFKB8488A']","['metabolic health', 'marked weight loss', 'Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}]",,0.0201048,Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ,"[{'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Baruch', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Leslie W', 'Initials': 'LW', 'LastName': 'Chinn', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Vaze', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Sonoda', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gelzleichter', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lewin-Koh', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA 91911.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Dheerendra', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Boismenu', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Gutierrez', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wakshull', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Puneet S', 'Initials': 'PS', 'LastName': 'Arora', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080; puneetarora.md@gmail.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2012073117']
1592,33140542,"Effect of the glucagon-like peptide-1 analogue liraglutide versus placebo treatment on circulating proglucagon-derived peptides that mediate improvements in body weight, insulin secretion and action: A randomized controlled trial.","AIM


To examine how circulating glucagon-like peptide-1 (GLP-1) concentrations during liraglutide treatment relate to its therapeutic actions on glucose and weight, and to study the effects of liraglutide on other proglucagon-derived peptides (PGDPs), including endogenous GLP-1, glucagon-like peptide-2, glucagon, oxyntomodulin, glicentin and major proglucagon fragment, which also regulate metabolic and weight control.
MATERIALS AND METHODS


Adults who were overweight/obese (body mass index 27-40 kg/m 2  ) with prediabetes were randomized to liraglutide (1.8 mg/day) versus placebo for 14 weeks. We used specific assays to measure exogenous (liraglutide, GLP-1 agonist [GLP-1A]) and endogenous (GLP-1E) GLP-1, alongside five other PGDP concentrations during a mixed meal tolerance test (MMTT) completed at baseline and at week 14 (liraglutide, n = 16; placebo, n = 19). Glucose during MMTT, steady-state plasma glucose (SSPG) concentration for insulin resistance and insulin secretion rate (ISR) were previously measured. MMTT area-under-the-curve (AUC) was calculated for ISR, glucose and levels of PGDPs.
RESULTS


Participants on liraglutide versus placebo had significantly (P ≤ .004) decreased weight (mean -3.6%, 95% CI [-5.2% to -2.1%]), SSPG (-32% [-43% to -22%]) and glucose AUC (-7.0% [-11.5% to -2.5%]) and increased ISR AUC (30% [16% to 44%]). GLP-1A AUC at study end was significantly (P ≤ .04) linearly associated with % decrease in weight (r = -0.54) and SSPG (r = -0.59) and increase in ISR AUC (r = 0.51) in the liraglutide group. Treatment with liraglutide significantly (P ≤ .005) increased exogenous GLP-1A AUC (median 310 vs. 262 pg/mL × 8 hours at baseline but decreased endogenous GLP-1E AUC [13.1 vs. 24.2 pmol/L × 8 hours at baseline]), as well as the five other PGDPs. Decreases in the PGDPs processed in the intestines are independent of weight loss, indicating a probable direct effect of GLP-1 receptor agonists to decrease their endogenous production in contrast to weight loss-dependent changes in glucagon and major proglucagon fragment that are processed in pancreatic alpha cells.
CONCLUSIONS


Circulating GLP-1A concentrations, reflecting liraglutide levels, predict improvement in weight, insulin action and secretion in a linear manner. Importantly, liraglutide also downregulates other PGDPs, normalization of the levels of which may provide additional metabolic and weight loss benefits in the future.",2020,Only glucagon AUC decreased in the placebo group (471 vs 594 pg/mL,['Adults who were overweight/obese (BMI 27-40 kg/m 2  ) with prediabetes'],"['liraglutide', 'liraglutide vs placebo', 'liraglutide vs. placebo', 'placebo', 'SSPG', 'exogenous (liraglutide, GLP-1 agonist (GLP-1A)) and endogenous (GLP-1E) GLP-1']","['endogenous GLP-1E AUC', 'weight (r=-0.54) and SSPG', 'weight', 'glucose AUC', 'ISR, glucose, and levels of PGDPs', 'glucagon AUC', 'ISR AUC', 'GLP-1A AUC', 'exogenous GLP-1A AUC', 'weight, insulin action, and secretion', 'Glucose during MMTT, steady-state plasma glucose (SSPG) concentration for insulin resistance, and insulin secretion rate (ISR', 'body weight, insulin secretion and action']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061359', 'cui_str': 'glucagon-like peptide 1 (7-36)amide'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072092', 'cui_str': 'Proglucagon'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061359', 'cui_str': 'glucagon-like peptide 1 (7-36)amide'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",,0.0995764,Only glucagon AUC decreased in the placebo group (471 vs 594 pg/mL,"[{'ForeName': 'Sun H', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Abbasi', 'Affiliation': 'Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Nachmanoff', 'Affiliation': 'Division of Endocrinology, Gerontology and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stefanakis', 'Affiliation': 'Department of Medicine, Boston VA Healthcare System and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Ansh Labs, Webster, Texas, USA.'}, {'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Kalra', 'Affiliation': 'Ansh Labs, Webster, Texas, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Savjani', 'Affiliation': 'Ansh Labs, Webster, Texas, USA.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Department of Medicine, Boston VA Healthcare System and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14242']
1593,33141065,Airflow dynamics and exhaled-breath temperature following cold-water ingestion.,"INTRODUCTION


Drinking cold water evokes decreases in spirometric indices of lung function. We studied whether this could be explained by changes in exhaled-breath temperature (EBT), airflow dynamics, and spirometer measurement sensitivity.
METHODS


In a randomized/crossover design, 10 healthy adults consumed 1000 mL refrigerated water (2.1 ± 0.64 °C) or water at room temperature (19.4 ± 0.5 °C), with EBT assessed at baseline and at 5, 10, 15 and 30-min post-ingestion. The influence of EBT on pneumotachograph measurement characteristics was modelled using computational fluid dynamics (CFD).
RESULTS


At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion. At a flow of 8 L s -1 , a decrease in EBT of 2.1 °C (as observed following cold-water ingestion) was modelled to underpredict lung volume by 0.7%.
CONCLUSIONS


Cold water reduces EBT below baseline but effects pneumotachograph measurements only negligibly. Therefore, decreased lung function following cold-water ingestion likely has a physiological explanation which warrants further study.",2020,"At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion.","['10 healthy adults consumed 1000 mL refrigerated water (2.1 ± 0.64 °C) or water at room temperature (19.4 ± 0.5 °C), with EBT assessed at baseline and at 5, 10, 15 and 30-min post-ingestion']",['EBT'],"['exhaled-breath temperature (EBT), airflow dynamics, and spirometer measurement sensitivity', 'EBT', 'spirometric indices of lung function', 'lung function', 'Airflow dynamics and exhaled-breath temperature']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517470', 'cui_str': '0.64'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0183441', 'cui_str': 'Spirometer'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",10.0,0.0478814,"At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion.","[{'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Tiller', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States. Electronic address: nicholas.tiller@lundquist.org.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Turner', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'Centre for Sports Engineering Research, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103564']
1594,33141078,"Aquatic exercise improves functional capacity, perceptual aspects, and quality of life in older adults with musculoskeletal disorders and risk of falling: A randomized controlled trial.","BACKGROUND


This study aimed to determine the effects of an aquatic training program on functional capacity, perceptual aspects, and quality of life (QoL) performed by older adults with musculoskeletal disorders (MSDs) and moderate/high risk of falls.
METHODS


This randomized controlled trial included 120 older adults assigned to aquatic exercises (AG; n = 60; 70.62 ± 6.04 years) and a control group (CG; n = 60; 71.86 ± 6.95 years). The risk of falls, perceptual aspects (fall risk awareness and pain), functional capacity (lower and upper body strength, lower and upper body flexibility, functional mobility, and balance) and QoL were assessed at baseline and after the experimental protocol. The AG performed 16 weeks of aquatic exercises (twice per week, 45 min.session -1 ) with lower and upper body strength, stretching, and balance exercises. Exercise intensity was controlled using the rate of perceived exertion (12-16 on the Borg scale [6-20 points]) and heart rate (progressing from 40% to 60% of the heart-rate reserve).
RESULTS


The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
CONCLUSIONS


The water-based program may be used as a preventive approach for the older adults with MSDs and at risk of falling to improve physical and usual perceptual aspects (QoL and pain) and fall risk awareness.",2020,"The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
","['120 older adults assigned to', 'older adults with musculoskeletal disorders (MSDs) and moderate/high risk of falls', 'older adults with musculoskeletal disorders and risk of falling', 'older adults with MSDs']","['aquatic training program', 'aquatic exercises', 'Aquatic exercise']","['risk of falls, perceptual aspects (fall risk awareness and pain), functional capacity (lower and upper body strength, lower and upper body flexibility, functional mobility, and balance) and QoL', 'Exercise intensity', 'fall risk awareness', 'functional capacity, perceptual aspects, and quality of life (QoL', 'functional capacity, perceptual aspects, and quality of life', 'pain perception', 'heart rate', 'QoL perception', 'upper body flexibility', 'functional mobility', 'upper body strength', 'rate of perceived exertion']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",120.0,0.0368855,"The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
","[{'ForeName': 'Natália Boneti', 'Initials': 'NB', 'LastName': 'Moreira', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: nataliamoreira@ufpr.br.'}, {'ForeName': 'Letícia Pophal', 'Initials': 'LP', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: leticiapophal@ufpr.br.'}, {'ForeName': 'André Luiz Felix', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Department of Physical Education, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: rodacki@ufpr.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111135']
1595,33141092,A Mobile-Based Intervention for Dietary Behavior and Physical Activity Change in Individuals at High Risk for Type 2 Diabetes Mellitus: Randomized Controlled Trial.,"BACKGROUND


Intensive lifestyle modifications have proved effective in preventing type 2 diabetes mellitus (T2DM), yet the efficiency and effectiveness of these modifications need to be improved. Emerging social media interventions are considered useful in promoting these lifestyles; nevertheless, few studies have investigated the effectiveness of combining them with behavior theory.
OBJECTIVE


This study aims to examine the effectiveness of a 6-month mobile-based intervention (DHealthBar, a WeChat applet) combined with behavioral theory compared with a printed intervention in improving dietary behaviors, physical activity, and intention to change these behaviors among populations at high risk for T2DM.
METHODS


Participants aged 23 to 67 years were recruited offline in Beijing, China, and were randomized into the intervention group or the control group, which received educational content via DHealthBar or a printed handbook, respectively. Educational materials were culturally tailored recommendations on improving dietary behaviors, physical activity, and intention to change based on the transtheoretical model. Participants in the intervention arm received push notifications twice per week on WeChat and had access to the educational content for the 6-month study period. Participants in the control arm received the same intervention content through printed materials. The outcomes of participants' behavior change, intention to change behavior, and anthropometric characteristics were collected via online measuring tools at baseline, 3 months, and 6 months.
RESULTS


In this study, 79 enrolled individuals completed baseline information collection (control: n=38 vs intervention: n=41), and 96% (76/79) completed the 6-month follow-up visit. Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61). Baseline equivalence was found. Participants in both groups reported a statistically significant decrease in energy intake at the 2 follow-up assessments compared with baseline (3 months, control: exp[β]=0.83, 95% CI 0.74-0.92 vs intervention: exp[β]=0.76, 95% CI 0.68-0.85; 6 months, control: exp[β]=0.87, 95% CI 0.78-0.96 vs intervention: exp[β]=0.57, 95% CI 0.51-0.64). At 6 months, a significantly larger decrease was observed in the intervention group in energy, fat, and carbohydrate intake, accompanied with a significantly larger increase in moderate-intensity physical activity compared with the control group (energy: exp[β]=0.66, 95% CI 0.56-0.77; fat: exp[β]=0.71, 95% CI 0.54-0.95; carbohydrates: exp[β]=0.83, 95% CI 0.66-1.03; moderate-intensity physical activity: exp[β]=2.05, 95% CI 1.23-3.44). After 6 months of the intervention, participants in the intervention group were more likely to be at higher stages of dietary behaviors (exp[β]=26.80, 95% CI 3.51-204.91) and physical activity (exp[β]=15.60, 95% CI 2.67-91.04) than the control group.
CONCLUSIONS


DHealthBar was initially effective in improving dietary behavior, physical activity, and intention to change these behaviors among populations who were at high risk of developing T2DM, with significant differences in the changes of outcomes over the 6-month intervention period.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR2000032323; https://tinyurl.com/y4h8q4uf.",2020,"Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61).","['populations at high risk for T2DM', 'Individuals at High Risk for Type 2 Diabetes Mellitus', '79 enrolled individuals completed baseline information collection (control: n=38 vs intervention: n=41), and 96% (76/79) completed the 6-month follow-up visit', 'Participants aged 23 to 67 years were recruited offline in Beijing, China']","['educational content via DHealthBar or a printed handbook, respectively', '6-month mobile-based intervention (DHealthBar, a WeChat applet) combined with behavioral theory compared with a printed intervention', 'push notifications twice per week on WeChat', 'Mobile-Based Intervention for Dietary Behavior and Physical Activity Change']","['dietary behavior, physical activity, and intention', ""participants' behavior change, intention to change behavior, and anthropometric characteristics"", 'dietary behaviors, physical activity, and intention to change based on the transtheoretical model', 'physical activity', 'moderate-intensity physical activity', 'energy intake', 'dietary behaviors', 'Attrition rates', 'energy, fat, and carbohydrate intake']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",79.0,0.149961,"Attrition rates did not differ significantly between the 2 groups (χ 2 1 =0.0, P=.61).","[{'ForeName': 'Zidu', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Geng', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Nursing Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Institute of Medical Information and Library, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",JMIR mHealth and uHealth,['10.2196/19869']
1596,33141101,Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Systemic lupus erythematosus is a systemic autoimmune disease, which is associated with high cardiovascular risk, a predisposition to metabolic disorders, muscle wasting, and fatigue. Exercise therapy has become an important part of the long-term treatment of comorbidities in systemic lupus erythematosus. Exercise can lead to various benefits in patients with systemic lupus erythematosus such as increased aerobic capacity and exercise tolerance, resulting in an increased quality of life, decreased depression, and decreased fatigue. At the moment, no evidence-based treatment guidelines that recommend exercise for patients with systemic lupus erythematosus exist. Also, the efficacy of different training programs requires further investigation.
OBJECTIVE


This study focuses on the feasibility, efficacy, and safety of an internet-based exercise program in patients with systemic lupus erythematosus. Furthermore, we investigate the feasibility and efficiency of anaerobic training compared to aerobic training.
METHODS


Overall, patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status are included and randomized in an aerobic exercise group (n=10), anaerobic exercise group (n=10), or treatment as usual group (n=10). After completing initial clinical testing and physical fitness tests, patients undergo supervised 12-week online exercise programs, receiving weekly individualized training plans adapted to their physical performance. The primary outcome is change in physical fitness (VO2 peak) after 12 weeks compared to baseline. Secondary outcomes are disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles.
RESULTS


The study was registered in May 2019. Enrollment began in May 2019. Of 40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program. Among the 25 patients who completed the study, no serious adverse events have been reported; 3 participants withdrew during the program (due to frequent colds, n=1; Crohn relapse, n=1; physical strain, n=1), and 1 participant has not yet completed the program. Data analysis is ongoing, and results are expected to be submitted for publication in January 2021.
CONCLUSIONS


We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03942718; http://clinicaltrials.gov/ct2/show/NCT03942718.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18291.",2020,"We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.
","['40 patients who were initially screened, 30 patients fulfilled the inclusion criteria and were included in the study; 1 participant withdrew prior to the start of the exercise program', 'Adults With Systemic Lupus Erythematosus', 'patients with systemic lupus erythematosus', 'patients with systemic lupus erythematosus from the Division of Nephrology, Rheumatology, and Immunology outpatient clinic of the University Medical Center Mainz who are clinically stable status', 'patients with systemic lupus erythematosus exist', '25 patients']","['Twelve-Week Internet-Based Individualized Exercise Program', 'online exercise intervention', 'anaerobic training', 'anaerobic exercise', 'aerobic exercise', 'internet-based exercise program', 'Exercise therapy']","['feasibility, efficacy, and safety', 'aerobic capacity and exercise tolerance', 'disease activity measured via laboratory results (complement, autoantibodies) and questionnaires, as well as changes in muscle mass (anaerobic exercise group), results of the Chair-Stand test, and measurements of circulating cell-free DNA and extracellular vesicles', 'change in physical fitness (VO2 peak']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4289789', 'cui_str': 'Cell free DNA'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.0821693,"We expect the online exercise intervention to be a feasible and efficient tool to provide regular individualized exercise for patients with systemic lupus erythematosus.
","[{'ForeName': 'Simone Cosima', 'Initials': 'SC', 'LastName': 'Boedecker', 'Affiliation': 'Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Keito Finn Akanby', 'Initials': 'KFA', 'LastName': 'Philippi', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Elmo', 'Initials': 'E', 'LastName': 'Neuberger', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pfirrmann', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schwarting', 'Affiliation': 'Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Perikles', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': 'Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Weinmann-Menke', 'Affiliation': 'Department of Rheumatology and Nephrology, University Medical Center Mainz, Mainz, Germany.'}]",JMIR research protocols,['10.2196/18291']
1597,33141103,Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND


Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery.
OBJECTIVE


This manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity.
METHODS


This pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start.
RESULTS


Recruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing.
CONCLUSIONS


The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18891.",2020,"The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.
","['adult primary care patients (aged 21-70 years) reporting inadequate activity levels', 'Recruitment took place between October 2018 and May 2019 (79 participants were randomized', '1:1 ratio within age strata 21-54 and 55-70 years']","['wait-listed control RCT', 'Online Physical Activity Intervention', '13-week online intervention']","['physical activity changes', 'average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers', 'physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}]",79.0,0.0816296,"The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician.
","[{'ForeName': 'Bonny', 'Initials': 'B', 'LastName': 'Rockette-Wagner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Kriska', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'Division of General Internal Medicine, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Roumpz', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}]",JMIR research protocols,['10.2196/18891']
1598,33160147,Tamoxifen related side effects and their impact on breast cancer incidence: A retrospective analysis of the randomised IBIS-I trial.,"BACKGROUND


Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial.
METHODS


Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation.
RESULTS


Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed.
CONCLUSIONS


Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.",2020,"A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01).","['Women randomised to', 'postmenopausal women']","['tamoxifen', 'Tamoxifen']","['breast cancer incidence', 'breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer', 'gynaecological side effects and breast cancer occurrence', 'breast cancer occurrence', 'hot flushes, vaginal discharge, and vaginal dryness', 'breast cancer', 'breast cancer risk', 'hot flushes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0825288,"A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hale', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Wilmslow Road, Manchester, M20 4BX, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, London, SW3 6JJ, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK. Electronic address: i.sestak@qmul.ac.uk.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.10.015']
1599,33160161,Nitrogen dioxide exposures from LPG stoves in a cleaner-cooking intervention trial.,"BACKGROUND


Liquefied petroleum gas (LPG) stoves have been promoted in low- and middle-income countries (LMICs) as a clean energy alternative to biomass burning cookstoves.
OBJECTIVE


We sought to characterize kitchen area concentrations and personal exposures to nitrogen dioxide (NO 2 ) within a randomized controlled trial in the Peruvian Andes. The intervention included the provision of an LPG stove and continuous fuel distribution with behavioral messaging to maximize compliance.
METHODS


We measured 48-hour kitchen area NO 2  concentrations at high temporal resolution in homes of 50 intervention participants and 50 control participants longitudinally within a biomass-to-LPG intervention trial. We also collected 48-hour mean personal exposures to NO 2  among a subsample of 16 intervention and 9 control participants. We monitored LPG and biomass stove use continuously throughout the trial.
RESULTS


In 367 post-intervention 24-hour kitchen area samples of 96 participants' homes, geometric mean (GM) highest hourly NO 2  concentration was 138 ppb (geometric standard deviation [GSD] 2.1) in the LPG intervention group and 450 ppb (GSD 3.1) in the biomass control group. Post-intervention 24-hour mean NO 2  concentrations were a GM of 43 ppb (GSD 1.7) in the intervention group and 77 ppb (GSD 2.0) in the control group. Kitchen area NO 2  concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants. GM 48-hour personal exposure to NO 2  was 5 ppb (GSD 2.4) among 35 48-hour samples of 16 participants in the intervention group and 16 ppb (GSD 2.3) among 21 samples of 9 participants in the control group.
DISCUSSION


In a biomass-to-LPG intervention trial in Peru, kitchen area NO 2  concentrations were substantially lower within the LPG intervention group compared to the biomass-using control group. However, within the LPG intervention group, 69% of 24-hour kitchen area samples exceeded WHO indoor annual guidelines and 47% of samples exceeded WHO indoor hourly guidelines. Forty-eight-hour NO 2  personal exposure was below WHO indoor annual guidelines for most participants in the LPG intervention group, and we did not measure personal exposure at high temporal resolution to assess exposure to cooking-related indoor concentration peaks. Further research is warranted to understand the potential health risks of LPG-related NO 2  emissions and inform current campaigns which promote LPG as a clean-cooking option.",2020,NO 2  concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants.,"[""96 participants' homes, geometric mean (GM) highest hourly""]","['LPG stove and continuous fuel distribution with behavioral messaging to maximize compliance', 'LPG intervention', 'Post-intervention', 'Liquefied petroleum gas (LPG) stoves', 'Nitrogen dioxide exposures from LPG stoves', 'nitrogen dioxide (NO 2 ']","['24-hour mean', 'NO 2  concentrations']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028160', 'cui_str': 'Nitrogen dioxide'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0467508,NO 2  concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants.,"[{'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Malpartida', 'Affiliation': 'Molecular Biology and Immunology Laboratory, Research Laboratory of Infectious Diseases, Department of Cell and Molecular Sciences, Faculty of Sciences and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru; Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Howard University, Washington, DC, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Naeher', 'Affiliation': 'Department of Environmental Health Science, College of Public Health, The University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Gonzales', 'Affiliation': 'Laboratories of Investigation and Development, Department of Biological and Physiological Sciences, Faculty of Sciences and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru; High Altitude Research Institute, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Marilu', 'Initials': 'M', 'LastName': 'Chiang', 'Affiliation': 'Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Program in Global Disease Epidemiology and Control, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: wcheckl1@jhmi.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.106196']
1600,33160256,'Everybody's Different: The Appearance Game'. A randomised controlled trial evaluating an appearance-related board game intervention with children aged 9-11 years.,"This study evaluated the effectiveness of an educational board game aimed at increasing knowledge of appearance-related issues, positive body image, media literacy, and acceptance of appearance diversity with British school children. Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial. Outcome measures were collected pre-, post- and at two-week follow-up. Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up. There were no significant differences between groups for body appreciation, media literacy or acceptance of visible difference. Of the intervention arm, 78 % (n=117) they would like to play again and 85.3 % (n=128) thought other children would like to play. Qualitative data suggests participants learned the key messages of the game. The findings suggest 'Everybody's Different: The Appearance Game' is an enjoyable way to increase knowledge of appearance-related issues. In future, researchers should consider how to increase body appreciation, media literacy and acceptance of appearance diversity, for example by increasing the dosage of the game or using it in conjunction with discussions and lessons surrounding appearance diversity and appearance-altering conditions.",2020,"Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up.","['children aged 9-11 years', 'Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial', 'British school children']","['appearance-related board game intervention', 'educational board game']","['body appreciation, media literacy or acceptance of visible difference']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205379', 'cui_str': 'Visible'}]",259.0,0.051015,"Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guest', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: ella.guest@uwe.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia. Electronic address: H.Jarman@latrobe.edu.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sharratt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Nick.Sharratt@uwe.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Williamson', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Heidi3.Williamson@uwe.ac.uk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Paul.White@uwe.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Harcourt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Diana2.Harcourt@uwe.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Amy.Slater@uwe.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}]",Body image,['10.1016/j.bodyim.2020.09.010']
1601,33164850,"Acute exercise, memory, and neural activation in young adults.","Acute exercise benefits memory, and the temporal placement of exercise relative to exposure can affect the magnitude of benefits observed. Although the temporal placement appears to be important, there is a limited understanding as to how cognitive benefits in response to acute exercise are achieved. Hence, we conducted a two-part study including a behavioral study and a follow-up functional magnetic resonance imaging (fMRI) study to advance our understanding of the potential role of the effects of exercise on memory and neural activation. For Study One, we assessed the effect of acute exercise on memory in young adults. Participants were randomized to exercise before exposure for 20 min (before only, BO), after exposure for 20 min (After Only, AO), before and after exposure for 10 min at each time (before and after, BA), or to receive no exercise (No-exercise Control, NC). Similar to previous findings, any exercise prior to exposure (BO, BA) benefited some aspects of memory performance. Interestingly, the more consistent and larger benefits were seen with a shorter duration of exercise both before and after exposure (BA). Study Two replicated the methods of Study One comparing the BA condition (which had the most robust benefits) to the NC condition while collecting fMRI data during the memory task. Analyses assessed condition differences of activation during encoding and recall. There were no condition differences during memory encoding, however there was a condition effect on activation in occipito-temporal regions during the memory recall trials. Consistent with previous research, exercise appears to benefit memory with some exercise prior to exposure being important for the benefits achieved. Further, exercise affects neural activation and the results appear complementary to the behavior findings. Future research should use a within-subjects design to control for heterogeneity in behavior and neural activation.",2020,"There were no condition differences during memory encoding, however there was a condition effect on activation in occipito-temporal regions during the memory recall trials.",['young adults'],"['no exercise (No-exercise Control, NC', 'acute exercise']","['Acute exercise, memory, and neural activation', 'memory and neural activation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0370187,"There were no condition differences during memory encoding, however there was a condition effect on activation in occipito-temporal regions during the memory recall trials.","[{'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Slutsky-Ganesh', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC, United States of America. Electronic address: abslutsk@uncg.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC, United States of America.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.09.018']
1602,33165586,Effectiveness of a nutrition education and counselling training package on antenatal care: a cluster randomized controlled trial in Addis Ababa.,"The World Health Organization (WHO) recommends the need for a strong nutrition training package for practitioners, including antenatal care (ANC) providers. Without such a training package, ANC visits remain a missed opportunity to address nutritional problems among pregnant women. This study evaluated the effectiveness of an in-service nutrition education and counselling package on the providers' counselling skills during ANC visits. A cluster randomized controlled trial was conducted in Addis Ababa, Ethiopia. All health-care providers working in ANC units across 20 health centres participated in this study. Health centres were allocated to intervention and control arms using a matched-pair randomization technique. An in-service nutrition education and counselling package, including training for ANC providers, supportive supervision and provision of modules, pamphlets and job aids, was provided for health centres assigned to the intervention arm. Observation checklists were used to assess the counselling skills of health-care providers. We used mixed-effect linear regression to evaluate the impact of the intervention. Significantly more health-care providers in the intervention arm informed pregnant women about the need to have one additional meal (Difference in proportion [DP] 49.17% vs -0.84%; DID 50.0%), about minimum required dietary diversity (DP 72.5% vs -2.5%; DID 75.0%) and about gestational weight gain (DP 68.33% vs -8.33%; DID 76.6%). Furthermore, providers improved in identifying key difficulties that pregnant women face (DP 28.34% vs -2.5%; DID 30.8%), and in recommending simple achievable actions on nutrition during pregnancy (DP 20.8% vs -10.9%; DID 31.6%). The intervention did not have statistically significant effects on how providers informed women about early initiation of breastfeeding (DP 6.67% vs 9.17%; DID -2.5%). The comprehensive in-service nutrition education and counselling package improved how ANC providers engaged with pregnant women and delivered nutrition messages during ANC consultations. This trial was registered in the Pan African Clinical Trial (PACTR registry, PACTR20170900 2477373; Date issued 21 September 2017).",2020,The intervention did not have statistically significant effects on how providers informed women about early initiation of breastfeeding (DP 6.67% vs 9.17%; DID -2.5%).,"['Addis Ababa, Ethiopia', 'pregnant women', ""providers' counselling skills during ANC visits"", 'All health-care providers working in ANC units across 20 health centres', 'Health centres']","['service nutrition education and counselling package', 'nutrition education and counselling training package']","['gestational weight gain', 'health-care providers', 'dietary diversity', 'early initiation of breastfeeding']","[{'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",,0.0843312,The intervention did not have statistically significant effects on how providers informed women about early initiation of breastfeeding (DP 6.67% vs 9.17%; DID -2.5%).,"[{'ForeName': 'Afrah Mohammedsanni', 'Initials': 'AM', 'LastName': 'Omer', 'Affiliation': 'Department of Nutrition and Dietetics, School of Public Health, College of Health Sciences, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Demewoz', 'Initials': 'D', 'LastName': 'Haile', 'Affiliation': 'Department of Nutrition and Dietetics, School of Public Health, College of Health Sciences, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Shikur', 'Affiliation': 'Department of Nutrition and Dietetics, School of Public Health, College of Health Sciences, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Erlyn Rachelle', 'Initials': 'ER', 'LastName': 'Macarayan', 'Affiliation': 'Harvard Global Health Institute, Cambridge, MA 02138, USA.'}, {'ForeName': 'Seifu', 'Initials': 'S', 'LastName': 'Hagos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Public Health, College of Health Sciences, Addis Ababa University, Ethiopia.'}]",Health policy and planning,['10.1093/heapol/czaa101']
1603,33142129,"Comparing stigmatizing attitudes toward anorexia nervosa, binge-eating disorder, avoidant-restrictive food intake disorder, and subthreshold eating behaviors in college students.","OBJECTIVE


The relative stigmatization of various eating disorders (ED) remains understudied, and there is no research examining stigma toward avoidant-restrictive food intake disorder (ARFID) or adult picky eating. The present study examined the relative stigmatization of various EDs and the subthreshold eating behaviors that are risk factors for their development, and the relation of gender differences to stigma.
METHOD


A sample of 1147 college students was recruited and completed the study online. Participants were randomized and presented with a vignette representing a clinical ED [anorexia nervosa (AN), binge-eating disorder (BED), ARFID] or a subthreshold eating presentation (restrained eating, emotional eating, picky eating). Participants completed measures of stigma and perceived psychopathology. A 6 (target eating behavior) × 2 (target gender) × 2 (participant gender) MANOVA and subsequent ANOVAs were employed.
RESULTS


Measures of stigma revealed significant main effects for eating presentation and participant gender. There were also significant interactions between eating presentation and participant gender. Men reported more stigmatizing views toward BED and AN compared to women. Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma. Participants rated BED and AN as more pathological than all other targets, emotional eating and ARFID as more pathological than picky eating and restrained eating, and restrained eating as less pathological than all other targets.
CONCLUSIONS


Future research should explore how the severity of eating behavior influences perceptions and at what level behaviors such as restriction are recognized as disordered.",2020,"Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma.","['college students', 'Participants were randomized and presented with a vignette representing a clinical ED [anorexia nervosa (AN), binge-eating disorder (BED), ARFID] or a subthreshold eating presentation (restrained eating, emotional eating, picky eating', '1147 college students']",[],['stigma and perceived psychopathology'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",1147.0,0.0365584,"Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma.","[{'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America; Wilford Hall Ambulatory Medical Center, Joint Base San Antonio - Lackland, United States of America. Electronic address: jordanellisphd@gmail.com.'}, {'ForeName': 'Jamal H', 'Initials': 'JH', 'LastName': 'Essayli', 'Affiliation': 'Department of Pediatrics and Psychiatry & Behavioral Health, Penn State College of Medicine, United States of America.'}, {'ForeName': 'Hana F', 'Initials': 'HF', 'LastName': 'Zickgraf', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rossi', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Hlavka', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Carels', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Matt C', 'Initials': 'MC', 'LastName': 'Whited', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101443']
1604,33142248,"Visualization of aggregate perioperative data improves anesthesia case planning: A randomized, cross-over trial.","STUDY OBJECTIVE


A challenge in reducing unwanted care variation is effectively managing the wide variety of performed surgical procedures. While an organization may perform thousands of types of cases, privacy and logistical constraints prevent review of previous cases to learn about prior practices. To bridge this gap, we developed a system for extracting key data from anesthesia records. Our objective was to determine whether usage of the system would improve case planning performance for anesthesia residents.
DESIGN


Randomized, cross-over trial.
SETTING


Vanderbilt University Medical Center.
MEASUREMENTS


We developed a web-based, data visualization tool for reviewing de-identified anesthesia records. First year anesthesia residents were recruited and performed simulated case planning tasks (e.g., selecting an anesthetic type) across six case scenarios using a randomized, cross-over design after a baseline assessment. An algorithm scored case planning performance based on care components selected by residents occurring frequently among prior anesthetics, which was scored on a 0-4 point scale. Linear mixed effects regression quantified the tool effect on the average performance score, adjusting for potential confounders.
MAIN RESULTS


We analyzed 516 survey questionnaires from 19 residents. The mean performance score was 2.55 ± SD 0.32. Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001). Additionally, a 0.055 point improvement due to the ""learning effect"" was observed from each assessment to the next (95% CI 0.034 to 0.077; p < 0.001). Assessment score was also significantly associated with specific case scenarios (p < 0.001).
CONCLUSIONS


This study demonstrated the feasibility of developing of a clinical data visualization system that aggregated key anesthetic information and found that the usage of tools modestly improved residents' performance in simulated case planning.",2020,Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001).,"['Vanderbilt University Medical Center', '516 survey questionnaires from 19 residents', 'First year anesthesia residents']",[],"['mean performance score', 'learning effect', 'Assessment score']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0730956,Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001).,"[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Wanderer', 'Affiliation': 'Department of Anesthesiology, Department of Biomedical Informatics, Vanderbilt University Medical Center, United States. Electronic address: jon.wanderer@vumc.org.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Lasko', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Coco', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Fowler', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'McEvoy', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Shotwell', 'Affiliation': 'Department of Biostatistics, Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gelfand', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Novak', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Owens', 'Affiliation': 'Owen Graduate School of Management, Vanderbilt University, United States.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Fabbri', 'Affiliation': 'Department of Biomedical Informatics, Department of Computer Science, Vanderbilt University Medical Center, United States.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110114']
1605,33142249,Dose dependent reduction in median effective concentration (EC 50 ) of ropivacaine with adjuvant dexmedetomidine in labor epidural analgesia: An up-down sequential allocation study.,"STUDY OBJECTIVE


Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia. However, the potency of dexmedetomidine has not been fully studied. The purpose of this study was to determine the median effective concentration (EC 50 ) of ropivacaine with adjuvant dexmedetomidine.
DESIGN


Prospective, double-blind, up-down sequential allocation study.
SETTING


Academic medical center specializing in the care of women and children.
PATIENTS


One hundred and fifty healthy, term parturients requesting labor epidural analgesia were randomly assigned to 1 of 5 different concentrations of dexmedetomidine: 0 μg/ml, 0.3 μg/ml, 0.4 μg/ml, 0.5 μg/ml, or 0.6 μg/ml.
INTERVENTIONS


The study solution for the first patient in each group included the randomly assigned concentration of dexmedetomidine in 0.1% ropivacaine. Subsequent patients in each randomization group received the assigned concentration of dexmedetomidine in a new concentration of ropivacaine as determined by the up-down allocation methodology. Effective analgesia was defined as pain on the visual analogue scale of<3 at30 min after administration of local anesthetic. The up-down sequential allocation method and probit regression were used to calculate the EC 50  of epidural ropivacaine.
MEASUREMENTS


The primary outcome was pain 30 min after administration of local anesthetic via epidural catheter. Exploratory outcomes included side effects, neonatal outcomes, and obstetric outcomes.
MAIN RESULTS


The EC 50  values for ropivacaine in dexmedetomidine 0.4 μg/ml, 0.5 μg/ml, and 0.6 μg/ml (0.044% [95% CI 0.036% to 0.045%], 0.035% [95% CI 0.031% to 0.041%], and 0.039% [95% CI 0.034% to 0.045%], respectively) were lower compared to ropivacaine in dexmedetomidine 0 μg/ml and 0.3 μg/ml (0.086% [95% CI 0.081% to 0.092%], and, 0.069% [95% CI 0.056% to 0.076%], respectively). Differences between EC 50  values for ropivacaine in dexmedetomidine 0.4 μg/ml, 0.5 μg/ml, and 0.6 μg/ml were not statistically significant. Results of our exploratory analyses did not reveal differences in side effects, neonatal outcomes, or obstetric outcomes.
CONCLUSIONS


In this study, the lowest concentration of dexmedetomidine in ropivacaine with the greatest clinical effect was 0.4 μg/ml, which is important because there may be no additional analgesic benefit of dexmedetomidine greater than 0.4 μg/ml.",2020,Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia.,"['Academic medical center specializing in the care of women and children', 'One hundred and fifty healthy, term parturients requesting labor epidural analgesia', 'labor epidural analgesia']","['dexmedetomidine: 0\xa0μg/ml, 0.3\xa0μg/ml', 'ropivacaine', 'dexmedetomidine']","['side effects, neonatal outcomes, or obstetric outcomes', 'median effective concentration', 'pain 30\xa0min after administration of local anesthetic via epidural catheter', 'side effects, neonatal outcomes, and obstetric outcomes']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}]",150.0,0.494868,Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Drzymalski', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Wangping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Lizhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China. Electronic address: 13706597501@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110115']
1606,33143327,Comparative Study of the Restorative Effects of Forest and Urban Videos during COVID-19 Lockdown: Intrinsic and Benchmark Values.,"The prolonged lockdown imposed to contain the COrona VIrus Disease 19 COVID-19 pandemic prevented many people from direct contact with nature and greenspaces, raising alarms for a possible worsening of mental health. This study investigated the effectiveness of a simple and affordable remedy for improving psychological well-being, based on audio-visual stimuli brought by a short computer video showing forest environments, with an urban video as a control. Randomly selected participants were assigned the forest or urban video, to look at and listen to early in the morning, and questionnaires to fill out. In particular, the State-Trait Anxiety Inventory (STAI) Form Y collected in baseline condition and at the end of the study and the Part II of the Sheehan Patient Rated Anxiety Scale (SPRAS) collected every day immediately before and after watching the video. The virtual exposure to forest environments showed effective to reduce perceived anxiety levels in people forced by lockdown in limited spaces and environmental deprivation. Although significant, the effects were observed only in the short term, highlighting the limitation of the virtual experiences. The reported effects might also represent a benchmark to disentangle the determinants of health effects due to real forest experiences, for example, the inhalation of biogenic volatile organic compounds (BVOC).",2020,The virtual exposure to forest environments showed effective to reduce perceived anxiety levels in people forced by lockdown in limited spaces and environmental deprivation.,[],['Forest and Urban Videos during COVID-19 Lockdown'],"['anxiety levels', 'State-Trait Anxiety Inventory (STAI']",[],"[{'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0240742,The virtual exposure to forest environments showed effective to reduce perceived anxiety levels in people forced by lockdown in limited spaces and environmental deprivation.,"[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Zabini', 'Affiliation': 'Institute for Bioeconomy, National Research Council, 10 Via Madonna del Piano, I-50019 Sesto Fiorentino (FI), Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Albanese', 'Affiliation': 'Institute for Bioeconomy, National Research Council, 10 Via Madonna del Piano, I-50019 Sesto Fiorentino (FI), Italy.'}, {'ForeName': 'Francesco Riccardo', 'Initials': 'FR', 'LastName': 'Becheri', 'Affiliation': 'Pian dei Termini Forest Therapy Station, 2311 Via Pratorsi, I-51028 San Marcello Piteglio, Italy.'}, {'ForeName': 'Gioele', 'Initials': 'G', 'LastName': 'Gavazzi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Fiorenza', 'Initials': 'F', 'LastName': 'Giganti', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Giovanelli', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gronchi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guazzini', 'Affiliation': 'Department of Education, Languages, Intercultural Studies, Literatures, and Psychology (FORLILPSI), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Laurino', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, 1 Via Giuseppe Moruzzi, I-56124 Pisa, Italy.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation and Physical Medicine, Graduate School of Medicine-Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Marzi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mastorci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, 1 Via Giuseppe Moruzzi, I-56124 Pisa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Meneguzzo', 'Affiliation': 'Institute for Bioeconomy, National Research Council, 10 Via Madonna del Piano, I-50019 Sesto Fiorentino (FI), Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Righi', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Viggiano', 'Affiliation': ""Section of Psychology-Department of Neuroscience, Psychology, Drug Research and Child's Health (NEUROFARBA), University of Florence, 12 Via di San Salvi, I-50135 Firenze, Italy.""}]",International journal of environmental research and public health,['10.3390/ijerph17218011']
1607,33143906,Effects of an educational intervention on health-related quality of life among family caregivers of people with dementia with a Turkish or Moroccan immigrant background: Insights from a cluster randomised controlled trial.,"OBJECTIVE


Gaining understanding of the health-related quality of life (HRQL) of family caregivers of people with dementia with Turkish or Moroccan immigrant backgrounds and to examine whether an educational peer group intervention can improve HRQL.
METHODS


Understanding of HRQL and associated variables was obtained by multiple linear regression analyses. The effects of the intervention on HRQL were assessed in multilevel analyses using data collected before the start (baseline), directly after the intervention (one to two weeks after baseline) and three months after the start of the intervention. The intervention (two interactive group sessions) entailed providing information about dementia and care/support options.
RESULTS


At baseline (n = 319), HRQL was moderately and significantly associated with migration background, gender, self-perceived pressure from informal care and the formal and informal support received (p < .05). The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).
CONCLUSION


Culturally sensitive peer group education on dementia and care/support options can to some extent enhance HRQL among family caregivers in the short term.
PRACTICE IMPLICATIONS


The intervention as described in this study is recommended for supporting family caregivers of people with dementia with Turkish or Moroccan backgrounds.",2020,"The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).
","['family caregivers of people with dementia with a Turkish or Moroccan immigrant background', 'family caregivers of people with dementia with Turkish or Moroccan immigrant backgrounds', 'family caregivers of people with dementia with Turkish or Moroccan backgrounds']","['educational intervention', 'educational peer group intervention', 'intervention (two interactive group sessions) entailed providing information about dementia and care/support options']","['migration background, gender, self-perceived pressure from informal care', 'health-related quality of life', 'HRQL', 'emotional wellbeing']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",,0.0665988,"The intervention had a small effect on emotional wellbeing directly after the intervention (p < .05) and on perceived general health status three months after (p < .05).
","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van der Heide', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands. Electronic address: i.vanderheide@nivel.nl.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Wezel', 'Affiliation': 'Alzheimer Nederland, Amersfoort, Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Blom', 'Affiliation': 'Alzheimer Nederland, Amersfoort, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Spreeuwenberg', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands.'}, {'ForeName': 'Walter L J M', 'Initials': 'WLJM', 'LastName': 'Devillé', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands; Faculty of Social and Behavioral Sciences, University of Amsterdam, Amsterdam, Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht, Netherlands.'}, {'ForeName': 'Anneke L', 'Initials': 'AL', 'LastName': 'Francke', 'Affiliation': 'Nivel, Netherlands Institute of Health Services Research, P.O. Box 1568, 3500 BN Utrecht, Netherlands; Department of Public and Occupational Health, Amsterdam Public Health Research Institute, VU University, Amsterdam, Netherlands.'}]",Patient education and counseling,['10.1016/j.pec.2020.10.029']
1608,33147205,Percutaneous Reduction and Hollow Screw Fixation Versus Open Reduction and Internal Fixation for Treating Displaced Intra-Articular Calcaneal Fractures.,"BACKGROUND We investigated the outcomes of displaced intra-articular calcaneal fractures (DIACFs) treated by percutaneous reduction and hollow screw fixation (PRHCF) versus open reduction and internal fixation (ORIF). MATERIAL AND METHODS Seventy-one patients were randomly allocated to group A (by PRHCF) and group B (by ORIF). Operative time, visual analogue scale (VAS) score, time from injury to operation, postoperative hospital stay, preoperative and postoperative radiographic measurements, and complications were recorded. Functional outcomes were assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) scores. RESULTS Finally, 59 patients were followed up for at least 12 months (range, 12-24 months). Group A showed significantly more advantages than group B in term of operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief during the first 3 days (P<0.001). However, more intraoperative fluoroscopy was required in group A than in group B (P<0.001). The calcaneal width, height, length, Böhler angle, and Gissane angle in each group were significantly improved postoperatively (all P<0.001), although not significantly different in the postoperative comparisons between both groups. The AOFAS scores were slightly superior in group A than in group B (88.3 vs. 86.4, P=0.08). The rate of incidence of postoperative complications was lower in group A than in group B (3.2% vs. 10.8%, respectively; OR, 0.28, 95% CI, 0.03 to 2.84), although there was no significant difference (P=0.337). CONCLUSIONS PRHCF showed comparable clinical and radiological outcomes as ORIF, demonstrating it is a safe and effective alternative in treating DIACFs.",2020,"Group A showed significantly more advantages than group B in term of operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief during the first 3 days (P<0.001).",['Seventy-one patients'],"['displaced intra-articular calcaneal fractures (DIACFs) treated by percutaneous reduction and hollow screw fixation (PRHCF) versus open reduction and internal fixation (ORIF', 'PRHCF', 'Percutaneous Reduction and Hollow Screw Fixation', 'Internal Fixation']","['rate of incidence of postoperative complications', 'AOFAS scores', 'calcaneal width, height, length, Böhler angle, and Gissane angle', 'intraoperative fluoroscopy', 'Operative time, visual analogue scale (VAS) score, time from injury to operation, postoperative hospital stay, preoperative and postoperative radiographic measurements, and complications', 'operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief', 'American Orthopaedic Foot and Ankle Society (AOFAS) scores']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332484', 'cui_str': 'Hollow shape'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",71.0,0.0487851,"Group A showed significantly more advantages than group B in term of operative time, intraoperative blood loss, time to operation, postoperative hospital stay, and postoperative pain relief during the first 3 days (P<0.001).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Lian', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Zhenqin', 'Initials': 'Z', 'LastName': 'Jiao', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926833']
1609,33147257,The avoidance of G-CSF and the addition of prophylactic corticosteroids after autologous stem cell transplantation for multiple myeloma patients appeal for the at-home setting to reduce readmission for neutropenic fever.,"BACKGROUND


Autologous stem cell transplantation (ASCT) remains the standard of care for young multiple myeloma (MM) patients; indeed, at-home ASCT has been positioned as an appropriate therapeutic strategy. However, despite the use of prophylactic antibiotics, neutropenic fever (NF) and hospital readmissions continue to pose as the most important limitations in the outpatient setting. It is possible that the febrile episodes may have a non-infectious etiology, and engraftment syndrome could play a more significant role. The aim of this study was to analyze the impact of both G-CSF withdrawal and the addition of primary prophylaxis with corticosteroids after ASCT.
METHODS


Between January 2002 and August 2018, 111 MM patients conditioned with melphalan were managed at-home beginning +1 day after ASCT. Three groups were established: Group A (n = 33) received standard G-CSF post-ASCT; group B (n = 32) avoided G-CSF post-ASCT; group C (n = 46) avoided G-CSF yet added corticosteroid prophylaxis post-ASCT.
RESULTS


The incidence of NF among the groups was reduced (64%, 44%, and 24%; P<0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07). The most important variables identified for NF were: HCT-CI >2 (OR 6.1; P = 0.002) and G-CSF avoidance plus corticosteroids (OR 0.1; P<0.001); and for hospital readmission: age ≥60 years (OR 14.6; P = 0.04) and G-CSF avoidance plus corticosteroids (OR 0.07; P = 0.05).
CONCLUSIONS


G-CSF avoidance and corticosteroid prophylaxis post ASCT minimize the incidence of NF in MM patients undergoing at-home ASCT. This approach should be explored in a prospective randomized clinical trial.",2020,"The incidence of NF among the groups was reduced (64%, 44%, and 24%; P<0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07).","['young multiple myeloma (MM) patients', 'MM patients undergoing at-home ASCT', 'Between January 2002 and August 2018, 111 MM patients conditioned with']","['prophylactic corticosteroids', 'Autologous stem cell transplantation (ASCT', 'standard G-CSF post-ASCT; group B (n = 32) avoided G-CSF post-ASCT; group C (n = 46) avoided G-CSF yet added corticosteroid prophylaxis post-ASCT', 'melphalan']","['hospital readmissions', 'incidence of NF']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}]",,0.0509138,"The incidence of NF among the groups was reduced (64%, 44%, and 24%; P<0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07).","[{'ForeName': 'Luis-Gerardo', 'Initials': 'LG', 'LastName': 'Rodríguez-Lobato', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Martínez-Roca', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Castaño-Díez', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Palomino-Mosquera', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Gutiérrez-García', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Pedraza', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Suárez-Lledó', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Rovira', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández de Larrea', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'María-Teresa', 'Initials': 'MT', 'LastName': 'Cibeira', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rosiñol', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Lozano', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Marín', 'Affiliation': 'Department of Hemotherapy and Hemostasis, Apheresis and Cellular Therapy Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Cid', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Lozano', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Moreno-Castaño', 'Affiliation': 'Department of Hematopathology, Laboratory of Hemostasis and Eritropathology, Biomedical Diagnosis Center (CDB), Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Palomo', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Díaz-Ricart', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gallego', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Hernando', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Segura', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Carreras', 'Affiliation': 'Barcelona Endothelium Team (BET), Josep Carreras Leukemia Research Institute, Barcelona, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Urbano-Ispizua', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bladé', 'Affiliation': 'Department of Hematology, Amyloidosis and Multiple Myeloma Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Department of Hematology, Home Care and Bone Marrow Transplantation Unit, Hospital Clínic of Barcelona, Barcelona, Spain.'}]",PloS one,['10.1371/journal.pone.0241778']
1610,33148066,A randomized controlled trial of a community health worker delivered home-based asthma intervention to improve pediatric asthma outcomes.,"OBJECTIVE


The objective of this study was to evaluate the effects of using Community Health Workers (CHWs) to deliver the home-based  Wee Wheezers  asthma education program on asthma symptoms among children with persistent asthma.
METHODS


In this randomized controlled trial of 151 children aged 2-9 years with persistent asthma, we assigned 75 to the intervention and 76 to the control. The primary outcome was caregiver-reported asthma symptom days. Secondary outcomes included asthma-related healthcare utilization, caregivers' asthma knowledge, illness perception and management behaviors, MDI-spacer administration technique, and home environmental triggers. Outcomes were collected at baseline, 3, 6, 9 and 12 months. A repeated measurements analytic approach with generalized estimating equations was used. To account for missing data, multiple imputation methods were employed.
RESULTS


At 3 and 6 months, improvement in symptom days was not significantly different between groups. However, at 9 and 12 months, the reduction in asthma symptom days was 2.15 and 2.31 days more respectively for those in the intervention group compared to the control. Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up. Improvement in habits regarding MDI use was significant at 3 and 6 months, and asthma routines were improved at 3 months. However, there was no change in asthma-related healthcare utilization or home environmental triggers.
CONCLUSION


Using CHWs to deliver a home-based asthma education program to caregivers of children with persistent asthma led to improvements in symptom days and several secondary outcomes. Expanding the use of CHWs to provide home-based interventions can help reduce disparities in children's health outcomes.",2020,"Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up.","['151 children aged 2-9 years with persistent asthma, we assigned 75 to the intervention and 76 to the control', 'children with persistent asthma', 'caregivers of children with persistent asthma']","['CHWs to deliver a home-based asthma education program', 'Community Health Worker Delivered Home-Based Asthma Intervention', 'Community Health Workers (CHWs', 'home-based  Wee Wheezers  asthma education program']","['caregiver-reported asthma symptom days', ""asthma-related healthcare utilization, caregivers' asthma knowledge, illness perception and management behaviors, MDI-spacer administration technique, and home environmental triggers"", 'MDI-spacer technique, knowledge and attitudes', 'asthma routines', 'symptom days', 'reduction in asthma symptom days']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0153064', 'cui_str': 'Western equine encephalitis'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",151.0,0.0818468,"Improvements in MDI-spacer technique, knowledge and attitudes were significant throughout follow-up.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Jonas', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Reznik', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1846746']
1611,33150590,Airway immune mediator levels during asthma-like symptoms in young children and their possible role in response to azithromycin.,"BACKGROUND


Asthma-like symptoms in young children are orchestrated by the local airway immune response, but current knowledge largely relies on in vitro airway models. Azithromycin has been shown to reduce the duration of episodes with asthma-like symptoms, but efficacy may depend on the individual child's immune response.
OBJECTIVES


To investigate in vivo upper airway immune mediator levels during episodes with asthma-like symptoms in young children and their ability to predict the clinical response to azithromycin treatment.
METHODS


A total of 535 children aged 0-3 years from the Copenhagen Prospective Studies of Asthma in Childhood-2010 mother-child cohort were examined for immune mediator levels in samples of nasal epithelial lining fluid during episodes with asthma-like symptoms as well as in the asymptomatic state. In a sub-study, children with recurrent asthma-like symptoms were randomized to either a 3-day course of oral azithromycin (10 mg/kg; n = 32) or placebo (n = 38). In the current study, we compared the pretreatment immune mediator levels with the clinical response to treatment with azithromycin in an exploratory post hoc analysis.
RESULTS


The immune mediator concentrations during vs outside episodes were significantly upregulated for IFN-ɣ (ratio 1.73), TNF-α (ratio 2.05), IL-1β (ratio 1.45), IL-10 (ratio 1.97), while CCL22 (ratio 0.65) was downregulated. Low levels of TNF-α and IL-10 and high levels of CCL22 predicted better treatment response to azithromycin (P-values < .05).
CONCLUSION


Upper airway immune mediator levels were altered during episodes of asthma-like symptoms, and levels of TNF-α, CCL22, and IL-10 may predict the response to azithromycin treatment.",2020,"Low levels of TNF-α and IL-10 and high levels of CCL22 predicted better treatment response to azithromycin (p-values < 0.05).
","['young children', 'episodes with asthma-like symptoms in young children', '535 children aged 0-3 years from the Copenhagen Prospective Studies of Asthma in Childhood-2010 mother-child cohort', 'children with recurrent asthma-like symptoms']","['Azithromycin', 'azithromycin', 'placebo', 'oral azithromycin']","['immune mediator concentrations', 'Low levels of TNF-α and IL-10 and high levels of CCL22', 'Upper airway immune mediator levels']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0674299', 'cui_str': 'CCL22 protein, human'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}]",535.0,0.0693218,"Low levels of TNF-α and IL-10 and high levels of CCL22 predicted better treatment response to azithromycin (p-values < 0.05).
","[{'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Carlsson', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Rasmussen', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Biotechnology and Biomedicine, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stokholm', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo L', 'Initials': 'BL', 'LastName': 'Chawes', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Bønnelykke', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Bisgaard', 'Affiliation': 'COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",Allergy,['10.1111/all.14651']
1612,33151971,"Maternal dysglycaemia, changes in the infant's epigenome modified with a diet and physical activity intervention in pregnancy: Secondary analysis of a randomised control trial.","BACKGROUND


Higher maternal plasma glucose (PG) concentrations, even below gestational diabetes mellitus (GDM) thresholds, are associated with adverse offspring outcomes, with DNA methylation proposed as a mediating mechanism. Here, we examined the relationships between maternal dysglycaemia at 24 to 28 weeks' gestation and DNA methylation in neonates and whether a dietary and physical activity intervention in pregnant women with obesity modified the methylation signatures associated with maternal dysglycaemia.
METHODS AND FINDINGS


We investigated 557 women, recruited between 2009 and 2014 from the UK Pregnancies Better Eating and Activity Trial (UPBEAT), a randomised controlled trial (RCT), of a lifestyle intervention (low glycaemic index (GI) diet plus physical activity) in pregnant women with obesity (294 contol, 263 intervention). Between 27 and 28 weeks of pregnancy, participants had an oral glucose (75 g) tolerance test (OGTT), and GDM diagnosis was based on diagnostic criteria recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), with 159 women having a diagnosis of GDM. Cord blood DNA samples from the infants were interrogated for genome-wide DNA methylation levels using the Infinium Human MethylationEPIC BeadChip array. Robust regression was carried out, adjusting for maternal age, smoking, parity, ethnicity, neonate sex, and predicted cell-type composition. Maternal GDM, fasting glucose, 1-h, and 2-h glucose concentrations following an OGTT were associated with 242, 1, 592, and 17 differentially methylated cytosine-phosphate-guanine (dmCpG) sites (false discovery rate (FDR) ≤ 0.05), respectively, in the infant's cord blood DNA. The most significantly GDM-associated CpG was cg03566881 located within the leucine-rich repeat-containing G-protein coupled receptor 6 (LGR6) (FDR = 0.0002). Moreover, we show that the GDM and 1-h glucose-associated methylation signatures in the cord blood of the infant appeared to be attenuated by the dietary and physical activity intervention during pregnancy; in the intervention arm, there were no GDM and two 1-h glucose-associated dmCpGs, whereas in the standard care arm, there were 41 GDM and 160 1-h glucose-associated dmCpGs. A total of 87% of the GDM and 77% of the 1-h glucose-associated dmCpGs had smaller effect sizes in the intervention compared to the standard care arm; the adjusted r2 for the association of LGR6 cg03566881 with GDM was 0.317 (95% confidence interval (CI) 0.012, 0.022) in the standard care and 0.240 (95% CI 0.001, 0.015) in the intervention arm. Limitations included measurement of DNA methylation in cord blood, where the functional significance of such changes are unclear, and because of the strong collinearity between treatment modality and severity of hyperglycaemia, we cannot exclude that treatment-related differences are potential confounders.
CONCLUSIONS


Maternal dysglycaemia was associated with significant changes in the epigenome of the infants. Moreover, we found that the epigenetic impact of a dysglycaemic prenatal maternal environment appeared to be modified by a lifestyle intervention in pregnancy. Further research will be needed to investigate possible medical implications of the findings.
TRIAL REGISTRATION


ISRCTN89971375.",2020,Cord blood DNA samples from the infants were interrogated for genome-wide DNA methylation levels using the Infinium Human MethylationEPIC BeadChip array.,"['Between 27 and 28 weeks of pregnancy, participants had an oral glucose (75 g) tolerance test (OGTT), and GDM diagnosis was based on diagnostic criteria recommended by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), with 159 women having a diagnosis of GDM', 'pregnant women with obesity modified the methylation signatures associated with maternal dysglycaemia', '557 women, recruited between 2009 and 2014 from the UK Pregnancies Better Eating and Activity Trial (UPBEAT', 'pregnant women with obesity (294 contol, 263 intervention']","['diet and physical activity intervention', 'dietary and physical activity intervention', 'lifestyle intervention (low glycaemic index (GI) diet plus physical activity']","['maternal plasma glucose (PG) concentrations', 'Maternal GDM, fasting glucose, 1-h, and 2-h glucose concentrations']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",557.0,0.0673385,Cord blood DNA samples from the infants were interrogated for genome-wide DNA methylation levels using the Infinium Human MethylationEPIC BeadChip array.,"[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Antoun', 'Affiliation': 'Biological Sciences, Institute of Developmental Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Negusse T', 'Initials': 'NT', 'LastName': 'Kitaba', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Titcombe', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Garratt', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sheila J', 'Initials': 'SJ', 'LastName': 'Barton', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Murray', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Joanna D', 'Initials': 'JD', 'LastName': 'Holbrook', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kobor', 'Affiliation': 'BC Childrens Hospital Research Institute, Centre for Molecular Medicine and Therapeutics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David Ts', 'Initials': 'DT', 'LastName': 'Lin', 'Affiliation': 'BC Childrens Hospital Research Institute, Centre for Molecular Medicine and Therapeutics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'MacIsaac', 'Affiliation': 'BC Childrens Hospital Research Institute, Centre for Molecular Medicine and Therapeutics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Graham C', 'Initials': 'GC', 'LastName': 'Burdge', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lillycrop', 'Affiliation': 'Biological Sciences, Institute of Developmental Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003229']
1613,33151986,A model mimicking catabolic inflammatory disease; a controlled randomized study in humans.,"OBJECTIVE


Inflammatory disease is catabolic and associated with insulin resistance, increased energy expenditure, lipolysis and muscle protein loss. The main contributors to these metabolic adaptations are inflammation, malnutrition and immobilisation. Controlled experimental models incorporating these central elements of hospitalisation are lacking. The aim of this study was to validate such a human experimental model.
METHODS


In a randomized crossover design, six healthy young men underwent; (i) overnight fast (CTR), or (ii) exposure to systemic lipopolysaccharide (1 ng/kg) combined with 36-hour fast and bed rest (CAT). The difference in insulin sensitivity between CAT and CTR was the main outcome, determined by a hyperinsulinemic euglycemic glucose clamp. Palmitate, glucose, urea, phenylalanine and tyrosine tracers were infused to estimate metabolic shifts during interventions. Indirect calorimetry was used to estimate energy expenditure and substrate oxidation.
RESULTS


Insulin sensitivity was 41% lower in CAT than in CTR (M-value, mg/kg/min): 4.3 ± 0.2 vs 7.3 ± 1.3, p<0.05. The median (min max) palmitate flux (μmol/min) was higher during CAT than in CTR (257.0 (161.7 365.4) vs 131.6 (92.3 189.4), p = 0.004), and protein kinetics did not differ between interventions. C-reactive peptide (mg/L) was elevated in CAT compared with CTR (30.57 ± 4.08 vs 1.03 ± 0.19, p<0.001). Energy expenditure increased by 6% during CAT compared with CTR (1869 ± 94 vs 1756 ± 58, p = 0.04), CAT having higher lipid oxidation rates (p = 0.01) and lower glucose oxidation rates (p = 0.03). Lipopolysaccharide caused varying abdominal discomfort 2 hours post-injection, which had disappeared the following day.
CONCLUSION


We found that combined systemic inflammation, fasting and bed rest induced marked insulin resistance and increased energy expenditure and lipolysis, rendering this controlled experimental model suitable for anti-catabolic intervention studies, mimicking clinical conditions.",2020,"RESULTS


Insulin sensitivity was 41% lower in CAT than in CTR (M-value, mg/kg/min): 4.3 ± 0.2 vs 7.3 ± 1.3, p<0.05.","['six healthy young men underwent', 'humans']","['Lipopolysaccharide', 'i) overnight fast (CTR), or (ii) exposure to systemic lipopolysaccharide (1 ng/kg) combined with 36-hour fast and bed rest (CAT']","['protein kinetics', 'insulin sensitivity', 'lipid oxidation rates', 'Insulin sensitivity', 'Energy expenditure', 'median (min max) palmitate flux', 'glucose oxidation rates', 'hyperinsulinemic euglycemic glucose clamp', 'Palmitate, glucose, urea, phenylalanine and tyrosine tracers']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1638318', 'cui_str': 'ng/kg'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015159', 'cui_str': 'Euglycemic Clamping'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}]",6.0,0.109541,"RESULTS


Insulin sensitivity was 41% lower in CAT than in CTR (M-value, mg/kg/min): 4.3 ± 0.2 vs 7.3 ± 1.3, p<0.05.","[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Mose', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ulla Ramer', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Nutrition & Health, R&D, Arla Foods Ingredients Group P/S, Viby, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'STENO Diabetes Center, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mads Bisgaard', 'Initials': 'MB', 'LastName': 'Bengtsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Arla Foods amba, Aarhus, Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0241274']
1614,33151988,Efficacy and safety of short-term therapy with indigo naturalis for ulcerative colitis: An investigator-initiated multicenter double-blind clinical trial.,"INTRODUCTION


Indigo naturalis (IN) is a blue pigment extracted from Assam indigo and other plants and has been confirmed to be highly effective for ulcerative colitis (UC) treatment in several clinical studies.
OBJECTIVE


We conducted a multicenter double-blind study to confirm the efficacy and safety of short-term IN administration.
METHODS


A multicenter, randomized controlled trial was conducted between December 2015 and October 2018 in our facilities. Forty-six patients with mild to moderate active UC (Lichtiger index: 5-10) were randomly assigned to the IN group or the placebo group and received 5 capsules (500 mg) twice a day for 2 weeks. We investigated the efficacy according to blood tests and the Lichtiger index before and after administration, and we also examined adverse events.
RESULTS


The analysis included 42 patients (20 males, 22 females) with an average age of 45 years. Nineteen patients were assigned to the placebo group, and 23 were assigned to the IN group. After treatment administration, in the placebo group, no change in the Lichtiger index was observed (7.47 to 6.95, p = 0.359), and hemoglobin was significantly reduced (12.7 to 12.4, p = 0.031), while in the IN group, the Lichtiger index (9.04 to 4.48, p = 0.001) and albumin (4.0 to 4.12, p = 0.022) improved significantly. Mild headaches were observed in 5 patients and 1 patient in the IN and placebo groups, respectively.
CONCLUSIONS


Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.",2020,"CONCLUSIONS


Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.","['ulcerative colitis', 'Forty-six patients with mild to moderate active UC', 'Nineteen patients', 'December 2015 and October 2018 in our facilities', '42 patients (20 males, 22 females) with an average age of 45 years']","['placebo', 'short-term therapy with indigo naturalis']","['efficacy and safety', 'Lichtiger index', 'Efficacy and safety', 'hemoglobin', 'Mild headaches']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021218', 'cui_str': 'Indigo'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",46.0,0.22389,"CONCLUSIONS


Short-term administration of IN is highly effective without serious adverse events such as pulmonary hypertension or intussusception and may prevent the occurrence of serious adverse events.","[{'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Takami', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Umeki', 'Affiliation': 'Department of Gastroenterology, Chiba-Nishi General Hospital, Matsudo, Chiba, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mochizuki', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Tokatsu Tsujinaka Hospital, Abiko, Chiba, Japan.'}, {'ForeName': 'Nobushige', 'Initials': 'N', 'LastName': 'Kakinoki', 'Affiliation': 'Department of Gastroenterology, Hitachi General Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Tokyo Medical University Ibaraki Medical Center, Inashiki-gun, Ibaraki, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Hoshino', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Yatsu Hoken Hospital, Narashino, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Omori', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Fujimori', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Yanaka', 'Affiliation': 'Department of Gastroenterology, Hitachi Medical Education and Research Center, University of Tsukuba Hospital, Hitachi, Ibaraki, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Mizokami', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Ohkusa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Kashiwa, Chiba, Japan.'}]",PloS one,['10.1371/journal.pone.0241337']
1615,33152029,Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial.,"Anesthesia with desflurane and remifentanil can be maintained with either fixed or titrated desflurane concentration. We hypothesized that the fixed-gas concentration (FG) method would reduce the number of anesthetic titrations without hypnotic and hemodynamic instability compared to the bispectral index (BIS)-guided (BG) method. Forty-eight patients were randomly allocated to the FG or BG groups. In the FG group, desflurane vaporizer setting was fixed at 1 age-corrected minimum alveolar concentration (MAC). In the BG group, desflurane was titrated to target a BIS level at 50. Remifentanil was titrated to maintain a systolic arterial pressure (SAP) of 120 mmHg in both groups. Our primary endpoint was the hypnotic stability measured by the wobble of BIS in performance analysis, and the secondary endpoints included the wobble of SAP, mean BIS value during surgery, and the number of anesthetic titrations. The BIS in the FG group showed significantly less wobble (3.9 ± 1.1% vs 5.5 ± 1.5%, P <0.001) but lower value (33 ± 6 vs 46 ± 7, P <0.001) than BG group. The wobble of SAP showed no difference between groups [median (inter-quartile range), 5.0 (4.1-7.5)% vs 5.2 (4.2-8.3)%, P = 0.557]. The numbers of anesthetic titrations in the FG group were significantly lower than the BG group (0 ± 0 vs 8 ± 5, P<0.001 for desflurane, 13 ± 13 vs 22 ± 17, P = 0.047 for remifentanil). Less wobble in BIS and reduced anesthetic titration without hemodynamic instability during the FG technique may be practical in balanced anesthesia using desflurane and remifentanil anesthesia. Clinical trial: This study was registered at ClinicalTrials.gov (NCT02283866).",2020,"The numbers of anesthetic titrations in the FG group were significantly lower than the BG group (0 ± 0 vs 8 ± 5, P<0.001 for desflurane, 13 ± 13 vs 22 ± 17, P = 0.047 for remifentanil).",['Forty-eight patients'],"['desflurane and remifentanil', 'desflurane and remifentanil anesthesia', 'Remifentanil', 'bispectral index-guided and fixed-gas concentration techniques', 'desflurane']","['wobble of SAP, mean BIS value during surgery, and the number of anesthetic titrations', 'hypnotic stability', 'systolic arterial pressure (SAP', 'numbers of anesthetic titrations']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",48.0,0.0469589,"The numbers of anesthetic titrations in the FG group were significantly lower than the BG group (0 ± 0 vs 8 ± 5, P<0.001 for desflurane, 13 ± 13 vs 22 ± 17, P = 0.047 for remifentanil).","[{'ForeName': 'Seong Mi', 'Initials': 'SM', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yoo Sun', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chul-Woo', 'Initials': 'CW', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Bin', 'Initials': 'SB', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0241828']
1616,33166179,"Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial.","RATIONALE


The COVID-19 pandemic struck an immunologically naïve, globally interconnected population. In the face of a new infectious agent causing acute respiratory failure for which there were no known effective therapies, rapid, often pragmatic trials were necessary to evaluate potential treatments, frequently starting with medications that are already marketed for other indications. Early in the pandemic, hydroxychloroquine and azithromycin were two such candidates.
OBJECTIVE


Assess the relative efficacy of hydroxychloroquine and azithromycin among hospitalized patients with COVID-19.
METHODS


We performed a randomized clinical trial of hydroxychloroquine vs. azithromycin among hospitalized patients with COVID-19. Treatment was 5 days of study medication. The primary endpoint was the COVID Ordinal Outcomes scale at day 14. Secondary endpoints included hospital-, ICU-, and ventilator-free days at day 28. The trial was stopped early after enrollment of 85 patients when a separate clinical trial concluded that a clinically important effect of hydroxychloroquine over placebo was definitively excluded. Comparisons were made a priori using a proportional odds model from a Bayesian perspective.
RESULTS


We enrolled 85 patients at 13 hospitals over 11 weeks. Adherence to study medication was high. The estimated odds ratio for less favorable status on the ordinal scale for hydroxychloroquine vs. azithromycin from the primary analysis was 1.07, with a 95% credible interval from 0.63 to 1.83 with a posterior probability of 60% that hydroxychloroquine was worse than azithryomycin. Secondary outcomes displayed a similar, slight preference for azithromycin over hydroxychloroquine. QTc prolongation was rare and did not differ between groups. The twenty safety outcomes were similar between arms with the possible exception of post-randomization onset acute kidney injury, which was more common with hydroxychloroquine (15% vs. 0%). Patients in the hydroxychloroquine arm received remdesivir more often than in the azithromycin arm (19% vs. 2%). There was no apparent association between remdesivir use and acute kidney injury.
CONCLUSIONS


While early termination limits the precision of our results, we found no suggestion of substantial efficacy for hydroxychloroquine over azithromycin. Acute kidney injury may be more common with hydroxychloroquine than azithromycin, although this may be due to the play of chance. Differential use of remdesivir may have biased our results in favor of hydroxychloroquine. Our results are consistent with conclusions from other trials that hydroxychloroquine cannot be recommended for inpatients with COVID-19; azithromycin may merit additional investigation.
CLINICAL TRIAL REGISTRATION


This trial was prospectively registered (NCT04329832) before enrollment of the first patient.",2020,"The estimated odds ratio for less favorable status on the ordinal scale for hydroxychloroquine vs. azithromycin from the primary analysis was 1.07, with a 95% credible interval from 0.63 to 1.83 with a posterior probability of 60% that hydroxychloroquine was worse than azithryomycin.","['hospitalized patients with COVID-19', '85 patients at 13 hospitals over 11 weeks', 'Hospitalized Patients with COVID-19 (HAHPS']","['hydroxychloroquine', 'hydroxychloroquine vs. azithromycin', 'Hydroxychloroquine vs. Azithromycin', 'azithryomycin', 'azithromycin', 'hydroxychloroquine and azithromycin', 'hydroxychloroquine over placebo']","['QTc prolongation', 'COVID Ordinal Outcomes scale', 'hospital-, ICU-, and ventilator-free days at day 28']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",85.0,0.458901,"The estimated odds ratio for less favorable status on the ordinal scale for hydroxychloroquine vs. azithromycin from the primary analysis was 1.07, with a 95% credible interval from 0.63 to 1.83 with a posterior probability of 60% that hydroxychloroquine was worse than azithryomycin.","[{'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States; samuel.brown@imail.org.'}, {'ForeName': 'Ithan', 'Initials': 'I', 'LastName': 'Peltan', 'Affiliation': 'Intermountain Medical Center, 98078, Division of Pulmonary & Critical Care Medicine, Murray, Utah, United States.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Intermountain Medical Center, Office of Research, Murray, Utah, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Leither', 'Affiliation': 'Intermountain Medical Center, 98078, Murray, Utah, United States.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Webb', 'Affiliation': 'Intermountain Medical Center, Division of Clinical Epidemiology and Infectious Diseases, Murray, Utah, United States.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Starr', 'Affiliation': 'Intermountain Medical Center, Internal Medicine, Murray, Utah, United States.'}, {'ForeName': 'Colin K', 'Initials': 'CK', 'LastName': 'Grissom', 'Affiliation': 'Intermountain Medical Center, Critical Care Medicine, Murray, Utah, United States.'}, {'ForeName': 'Whitney R', 'Initials': 'WR', 'LastName': 'Buckel', 'Affiliation': 'Intermountain Medical Center, Pharmacy, Murray, Utah, United States.'}, {'ForeName': 'Rajendu', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Intermountain Medical Center, 98078, Office of Research, Murray, Utah, United States.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Butler', 'Affiliation': 'Intermountain Healthcare, Statistical Data Center, Salt Lake City, Utah, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Groat', 'Affiliation': 'Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Haaland', 'Affiliation': 'University of Utah, Biostatistics, Salt Lake City, Utah, United States.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'University of Utah, Biostatistics, Salt Lake City, Utah, United States.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Harris', 'Affiliation': 'University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'University of Utah School of Medicine, 12348, Internal Medicine, Salt Lake City, Utah, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paine', 'Affiliation': 'University of Utah, Salt Lake City, Utah, United States.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'University of Utah School of Medicine, 12348, Study Design and Biostatistics Center and Division of Epidemiology, Salt Lake City, Utah, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202008-940OC']
1617,33166307,"Intranasal GSK2245035, a Toll-like receptor 7 agonist, does not attenuate the allergen-induced asthmatic response in a randomized, double-blind, placebo-controlled experimental medicine study.","BACKGROUND


Allergic asthma is a heterogenous disorder predominantly driven by a type 2 inflammatory response to aeroallergens. Therapeutic modulation to rebalance these type 2 responses may offer clinical benefit for allergic respiratory inflammatory diseases, with the potential for disease modification. GSK2245035, a selective toll-like receptor-7 agonist, preferentially stimulates the induction of type 1 interferon alpha, reducing type 2 responses.
OBJECTIVE


This study investigated whether intranasal GSK2245035 reduced allergen-induced bronchial reactivity in mild allergic asthma.
METHODS


This double-blind, placebo-controlled, parallel-group Phase IIa trial randomized (1:1) participants with mild allergic asthma to intranasal GSK2245035 20 ng or placebo once weekly for 8 weeks; follow-up was conducted 1, 4, and 12 weeks after treatment. Allergen-induced late asthmatic response 1 week after treatment was measured as minimum and weighted mean forced expiratory volume in 1 second (FEV1) 4-10 hours following bronchial allergen challenge (primary endpoint). Pharmacodynamic and allergic biomarkers, and adverse events, were assessed. A Bayesian analysis framework was used; a posterior probability >0.7 denoted primary endpoint success.
RESULTS


Thirty-six participants were randomized (GSK2245035, n = 22; placebo, n = 14). The percentage attenuation in late asthmatic response was -4.6% (posterior probability: 0.385) and -10.5% (posterior probability: 0.303) for minimum and weighted mean FEV1, respectively. Type 2 responses were confirmed by changes in lung function, eosinophils (blood and sputum), interleukin-5 (sputum) and fractional exhaled nitric oxide biomarkers pre- and post-bronchial allergen challenge. However, no treatment effect was observed. Adverse events were reported by 10/14 (71%) and 21/22 (95%) participants in the placebo and GSK2245035 groups, respectively; headache was the most common.
CONCLUSIONS AND CLINICAL RELEVANCE


Although target engagement was observed, weekly intranasal GSK2245035 20 ng for 8 weeks did not substantially attenuate the late asthmatic response in participants with mild allergic asthma. Overall, treatment was well tolerated.",2020,"GSK2245035, a selective toll-like receptor-7 agonist, preferentially stimulates the induction of type 1 interferon alpha, reducing type 2 responses.
","['participants with mild allergic asthma to', 'Thirty-six participants', 'mild allergic asthma', 'participants with mild allergic asthma']","['intranasal GSK2245035', 'placebo', 'Intranasal GSK2245035', 'GSK2245035']","['late asthmatic response', 'headache', 'Pharmacodynamic and allergic biomarkers, and adverse events', 'Adverse events', 'percentage attenuation in late asthmatic response', 'lung function, eosinophils (blood and sputum), interleukin-5 (sputum) and fractional exhaled nitric oxide biomarkers pre- and post-bronchial allergen challenge', 'tolerated']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C4079591', 'cui_str': 'GSK2245035'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006265', 'cui_str': 'Bronchial provocation test'}]",36.0,0.634977,"GSK2245035, a selective toll-like receptor-7 agonist, preferentially stimulates the induction of type 1 interferon alpha, reducing type 2 responses.
","[{'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Siddall', 'Affiliation': 'Research and development, GSK, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Quint', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Hitesh', 'Initials': 'H', 'LastName': 'Pandya', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Powley', 'Affiliation': 'Biostatistics, GSK, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Shabbir', 'Affiliation': 'Immuno-Inflammation Global Clinical Sciences & Delivery, GSK, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Respiratory, Medicines Evaluation Unit, Manchester, United Kingdom.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Clinical development, GSK, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0240964']
1618,33167759,Comparison between video-lighted stylet (Intular Scope™) and direct laryngoscope for endotracheal intubation in patients with normal airway.,"OBJECTIVE


The Intular Scope™ (Medical Park, South Korea) (IS) is a video-lighted stylet that can be used for endotracheal intubation with excellent visualization by adding a camera to its end. We compared the efficacy of a direct laryngoscope (DL) with that of the IS based on hemodynamic changes, ease of intubation, and postoperative airway morbidities.
METHODS


Seventy patients with expected normal airways were randomized for intubation using an IS (n = 35) or DL (n = 35). The primary outcome was the mean arterial pressure during intubation. The secondary outcomes were the time to intubation (TTI), percentage of glottic opening (POGO) score, and number of intubation attempts. The incidence and severity of bleeding, hoarseness, and sore throat after intubation were also recorded.
RESULTS


Hemodynamic changes during intubation were not significantly different between the groups. The TTI was longer in the IS than DL group. The POGO score was higher in the IS than DL group. Hoarseness and sore throat were significantly less severe in the IS than DL group.
CONCLUSIONS


Using the IS did not significantly improve hemodynamics and resulted in a longer TTI. However, the IS was associated with less severe postoperative airway morbidities compared with the DL.",2020,"Hoarseness and sore throat were significantly less severe in the IS than DL group.
","['patients with normal airway', 'Seventy patients with expected normal airways']","['DL', 'video-lighted stylet (Intular Scope™) and direct laryngoscope', 'direct laryngoscope (DL']","['severe postoperative airway morbidities', 'mean arterial pressure during intubation', 'POGO score', 'hemodynamic changes, ease of intubation, and postoperative airway morbidities', 'Hoarseness and sore throat', 'time to intubation (TTI), percentage of glottic opening (POGO) score, and number of intubation attempts', 'incidence and severity of bleeding, hoarseness, and sore throat after intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1301933', 'cui_str': 'Airway morbidity'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",70.0,0.132779,"Hoarseness and sore throat were significantly less severe in the IS than DL group.
","[{'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Hur', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Wol Seon', 'Initials': 'WS', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.'}]",The Journal of international medical research,['10.1177/0300060520969532']
1619,33167780,Impact of baseline COPD symptom severity on the benefit from dual  versus  mono-bronchodilators: an analysis of the EMAX randomised controlled trial.,"RATIONALE


Symptom relief is a key treatment goal in patients with chronic obstructive pulmonary disease (COPD). However, there are limited data available on the response to bronchodilator therapy in patients at low risk of exacerbations with different levels of symptom severity. This study compared treatment responses in patients with a range of symptom severities as indicated by baseline COPD assessment test (CAT) scores.
METHODS


The 24-week EMAX trial evaluated the benefits of umeclidinium/vilanterol  versus  umeclidinium or salmeterol in symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids. This analysis assessed lung function, symptoms, health status, and short-term deterioration outcomes in subgroups defined by a baseline CAT score [<20 ( post hoc ) and ⩾20 (pre-specified)]. Outcomes were also assessed using  post hoc  fractional polynomial modelling with continuous transformations of baseline CAT score covariates.
RESULTS


Of the intent-to-treat population ( n  = 2425), 56% and 44% had baseline CAT scores of <20 and ⩾20, respectively. Umeclidinium/vilanterol demonstrated favourable improvements compared with umeclidinium and salmeterol for the majority of outcomes irrespective of the baseline CAT score, with the greatest improvements generally observed in patients with CAT scores <20. Fractional polynomial analyses revealed consistent improvements in lung function, symptoms and reduction in rescue medication use with umeclidinium/vilanterol  versus  umeclidinium and salmeterol across a range of CAT scores, with the largest benefits seen in patients with CAT scores of approximately 10-21.
CONCLUSIONS


Patients with symptomatic COPD benefit similarly from dual bronchodilator treatment with umeclidinium/vilanterol. Fractional polynomial analyses demonstrated the greatest treatment differences favouring dual therapy in patients with a CAT score <20, although benefits were seen up to scores of 30. This suggests that dual bronchodilation may be considered as initial therapy for patients across a broad range of symptom severities, not only those with severe symptoms (CAT ⩾20). Trial registration:  NCT03034915, 2016-002513-22 (EudraCT number). The reviews of this paper are available via the supplemental material section.",2020,"Fractional polynomial analyses revealed consistent improvements in lung function, symptoms and reduction in rescue medication use with umeclidinium/vilanterol  versus  umeclidinium and salmeterol across a range of CAT scores, with the largest benefits seen in patients with CAT scores of approximately 10-21.
","['2016-002513-22 (EudraCT number', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with a range of symptom severities', 'symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids']","['umeclidinium/vilanterol  versus  umeclidinium or salmeterol', 'dual  versus  mono-bronchodilators']","['baseline CAT score', 'baseline CAT scores', 'lung function, symptoms and reduction in rescue medication', 'baseline COPD assessment test (CAT) scores', 'lung function, symptoms, health status, and short-term deterioration outcomes']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.275092,"Fractional polynomial analyses revealed consistent improvements in lung function, symptoms and reduction in rescue medication use with umeclidinium/vilanterol  versus  umeclidinium and salmeterol across a range of CAT scores, with the largest benefits seen in patients with CAT scores of approximately 10-21.
","[{'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-Universität Marburg, Germany.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, OR, USA.'}, {'ForeName': 'Leif H', 'Initials': 'LH', 'LastName': 'Bjermer', 'Affiliation': 'Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Tombs', 'Affiliation': 'Precise Approach Ltd, Contingent Worker on Assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Jones', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Isabelle H', 'Initials': 'IH', 'LastName': 'Boucot', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Ian P', 'Initials': 'IP', 'LastName': 'Naya', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Respiratory Clinical Sciences, GSK, Collegeville, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'GSK, Brentford, Middlesex, UK.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Pneumologie, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Québec, Québec, Canada.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620968500']
1620,33168045,Developing and validating an integrated gross tumor volume (GTV)-TNM stratification system for supplementing unresectable locally advanced non-small cell lung cancer treated with concurrent chemoradiotherapy.,"PURPOSE


The gross tumor volume (GTV) could be an independent prognostic factor for unresectable locally advanced non-small cell lung cancer (LANSCLC). We aimed to develop and validate a novel integrated GTV-TNM stratification system to supplement LANSCLC sub-staging in patients treated with concurrent chemoradiotherapy (CCRT).
METHODS


We performed a retrospective review of 340 patients with unresectable LANSCLC receiving definitive CCRT. All included patients were divided into two randomized cohorts. Then the Kaplan-Meier method and Cox regression were calculated to access the prognostic value of the integrated GTV-TNM stratification system, which was further validated by the area under the receiver operating characteristic curve (AUC) score and F1-score.
RESULTS


The optimal outcome-based GTV cut-off values (70 and 180 cm 3 ) of the modeling cohort were used to determine each patient's integrated GTV-TNM stratum in the whole cohort. Our results indicated that a lower integrated GTV-TNM stratum could had better overall survival and progression-free survival (all P < 0.001), which was recognized as an independent prognostic factor. Also, its prognostic value was robust in both the modeling and validation cohorts. Furthermore, the prognostic validity of the integrated GTV-TNM stratification system was validated by significantly improved AUC score (0.636 vs. 0.570, P = 0.027) and F1-score (0.655 vs. 0.615, P < 0.001), compared with TNM stage.
CONCLUSIONS


We proposed a novel integrated GTV-TNM stratification system to supplement unresectable LANSCLC sub-staging due to its prognostic value independent of TNM stage and other clinical characteristics, suggesting that it could be considered in individual treatment decision-making process.",2020,"Our results indicated that a lower integrated GTV-TNM stratum could had better overall survival and progression-free survival (all P < 0.001), which was recognized as an independent prognostic factor.","['patients treated with concurrent chemoradiotherapy (CCRT', '340 patients with unresectable LANSCLC receiving definitive CCRT', 'unresectable locally advanced non-small cell lung cancer (LANSCLC']","['concurrent chemoradiotherapy', 'integrated gross tumor volume (GTV)-TNM stratification system']","['overall survival and progression-free survival', 'AUC score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",340.0,0.0612311,"Our results indicated that a lower integrated GTV-TNM stratum could had better overall survival and progression-free survival (all P < 0.001), which was recognized as an independent prognostic factor.","[{'ForeName': 'Nai-Bin', 'Initials': 'NB', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Qi-Wen', 'Initials': 'QW', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Zheng-Fei', 'Initials': 'ZF', 'LastName': 'Zhu', 'Affiliation': ""Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.""}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, The First Affiliated Hospital of Jinan University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhangkai J', 'Initials': 'ZJ', 'LastName': 'Cheng', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Zhou-Guang', 'Initials': 'ZG', 'LastName': 'Hui', 'Affiliation': ""Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Su-Ping', 'Initials': 'SP', 'LastName': 'Guo', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Hao-Qiang', 'Initials': 'HQ', 'LastName': 'He', 'Affiliation': ""Medical Imaging, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': ""Clinical Research, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jin-Yu', 'Initials': 'JY', 'LastName': 'Guo', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Xin-Lei', 'Initials': 'XL', 'LastName': 'Ai', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Evidance Medical Technologies Inc., Ningbo, People's Republic of China.""}, {'ForeName': 'Da-Quan', 'Initials': 'DQ', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Fang-Jie', 'Initials': 'FJ', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China.""}, {'ForeName': 'Chuan-Miao', 'Initials': 'CM', 'LastName': 'Xie', 'Affiliation': ""Medical Imaging, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qiu', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China. qiubo@sysucc.org.cn.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, Guangdong, 510060, People's Republic of China. liuhuisysucc@sina.com.""}]","Radiation oncology (London, England)",['10.1186/s13014-020-01704-2']
1621,33168097,Impact of an e-learning module on personal protective equipment knowledge in student paramedics: a randomized controlled trial.,"BACKGROUND


Prehospital professionals such as emergency physicians or paramedics must be able to choose and adequately don and doff personal protective equipment (PPE) in order to avoid COVID-19 infection. Our aim was to evaluate the impact of a gamified e-learning module on adequacy of PPE in student paramedics.
METHODS


This was a web-based, randomized 1:1, parallel-group, triple-blind controlled trial. Student paramedics from three Swiss schools were invited to participate. They were informed they would be presented with both an e-learning module and an abridged version of the current regional prehospital COVID-19 guidelines, albeit not in which order. After a set of 22 questions designed to assess baseline knowledge, the control group was shown the guidelines before answering a set of 14 post-intervention questions. The e-learning group was shown the gamified e-learning module right after the guidelines, and before answering post-intervention questions. The primary outcome was the difference in the percentage of adequate choices of PPE before and after the intervention.
RESULTS


The participation rate was of 71% (98/138). A total of 90 answer sets was analyzed. Adequate choice of PPE increased significantly both in the control (50% [33;83] vs 25% [25;50], P = .013) and in the e-learning group (67% [50;83] vs 25% [25;50], P = .001) following the intervention. Though the median of the difference was higher in the e-learning group, there was no statistically significant superiority over the control (33% [0;58] vs 17% [- 17;42], P = .087). The e-learning module was of greatest benefit in the subgroup of student paramedics who were actively working in an ambulance company (42% [8;58] vs 25% [- 17;42], P = 0.021). There was no significant effect in student paramedics who were not actively working in an ambulance service (0% [- 25;33] vs 17% [- 8;50], P = .584).
CONCLUSIONS


The use of a gamified e-learning module increases the rate of adequate choice of PPE only among student paramedics actively working in an ambulance service. In this subgroup, combining this teaching modality with other interventions might help spare PPE and efficiently protect against COVID-19 infection.",2020,The use of a gamified e-learning module increases the rate of adequate choice of PPE only among student paramedics actively working in an ambulance service.,"['Student paramedics from three Swiss schools were invited to participate', 'student paramedics', 'student paramedics actively working in an ambulance service']","['gamified e-learning module', 'e-learning module']","['rate of adequate choice of PPE', 'percentage of adequate choices of PPE', 'Adequate choice of PPE', 'ambulance service', 'participation rate', 'personal protective equipment knowledge']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",90.0,0.123574,The use of a gamified e-learning module increases the rate of adequate choice of PPE only among student paramedics actively working in an ambulance service.,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva 14, Switzerland. laurent.suppan@hcuge.ch.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, Switzerland.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Gartner', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva 14, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larribau', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Rue Gabrielle-Perret-Gentil 4, 1211, Geneva 14, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Iten', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abbas', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00849-9']
1622,33168602,Comparison of the Efficacy and Safety of Tacrolimus and Low-Dose Corticosteroid with High-Dose Corticosteroid for Minimal Change Nephrotic Syndrome in Adults.,"BACKGROUND


Tacrolimus is used as a steroid-sparing immunosuppressant in adults with minimal change nephrotic syndrome. However, combined treatment with tacrolimus and low-dose steroid has not been compared with high-dose steroid for induction of clinical remission in a large-scale randomized study.
METHODS


In this 24-week open-label noninferiority study, we randomized 144 adults with minimal change nephrotic syndrome to receive 0.05 mg/kg twice-daily tacrolimus plus once-daily 0.5 mg/kg prednisolone, or once-daily 1 mg/kg prednisolone alone, for up to 8 weeks or until achieving complete remission. Two weeks after complete remission, we tapered the steroid to a maintenance dose of 5-7.5 mg/d in both groups until 24 weeks after study drug initiation. The primary end point was complete remission within 8 weeks (urine protein: creatinine ratio <0.2 g/g). Secondary end points included time until remission and relapse rates (proteinuria and urine protein: creatinine ratio >3.0 g/g) after complete remission to within 24 weeks of study drug initiation.
RESULTS


Complete remission within 8 weeks occurred in 53 of 67 patients (79.1%) receiving tacrolimus and low-dose steroid and 53 of 69 patients (76.8%) receiving high-dose steroid; this difference demonstrated noninferiority, with an upper confidence limit below the predefined threshold (20%) in both intent-to-treat (11.6%) and per-protocol (17.0%) analyses. Groups did not significantly differ in time until remission. Significantly fewer patients relapsed on maintenance tacrolimus (3-8 ng/ml) plus tapered steroid versus tapered steroid alone (5.7% versus 22.6%, respectively;  P =0.01). There were no clinically relevant safety differences.
CONCLUSIONS


Combined tacrolimus and low-dose steroid was noninferior to high-dose steroid for complete remission induction in adults with minimal change nephrotic syndrome. Relapse rates were significantly lower with maintenance tacrolimus and steroid compared with steroid alone. No clinically-relevant differences in safety findings were observed.",2020,The primary end point was complete remission within 8 weeks (urine protein: creatinine ratio <0.2 g/g).,"['Minimal Change Nephrotic Syndrome in Adults', 'adults with minimal change nephrotic syndrome', '144 adults with minimal change nephrotic syndrome to receive 0.05 mg']","['Tacrolimus and Low-Dose Corticosteroid with High-Dose Corticosteroid', 'tacrolimus', 'Tacrolimus', 'kg twice-daily tacrolimus plus once-daily 0.5 mg/kg prednisolone, or once-daily 1 mg/kg prednisolone']","['time until remission', 'time until remission and relapse rates (proteinuria and urine protein: creatinine ratio', 'Relapse rates', 'Complete remission', 'complete remission']","[{'cui': 'C1704321', 'cui_str': 'Minimal Change Nephrotic Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",144.0,0.281961,The primary end point was complete remission within 8 weeks (urine protein: creatinine ratio <0.2 g/g).,"[{'ForeName': 'Ho Jun', 'Initials': 'HJ', 'LastName': 'Chin', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Chae', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Yong Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Won Suk', 'Initials': 'WS', 'LastName': 'An', 'Affiliation': 'Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.'}, {'ForeName': 'ChunGyoo', 'Initials': 'C', 'LastName': 'Ihm', 'Affiliation': 'Department of Nephrology, Kyunghee University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Dong-Chan', 'Initials': 'DC', 'LastName': 'Jin', 'Affiliation': 'Department of Internal Medicine, St Vincent Hospital, Suwon, South Korea.'}, {'ForeName': 'Sung Gyun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Yong-Soo', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': ""Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Yoon-Goo', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ho Seok', 'Initials': 'HS', 'LastName': 'Koo', 'Affiliation': 'Department of Internal Medicine, Inje University Seoul Paik Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kang Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Nephrology, Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Kangdong Sacred Heart Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung Hwan', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Konkuk University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hongsi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Medical Affairs Asia Oceania, Astellas Pharma Singapore Pte. Ltd., Singapore.'}, {'ForeName': 'Hyuncheol', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Clinical Research, Astellas Pharma Korea Inc., Seoul, South Korea.'}, {'ForeName': 'Sang Koo', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea sklee2@amc.seoul.kr.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019050546']
1623,33168796,Renal Function in Patients with or without a Left Ventricular Assist Device Implant During Listing for a Heart Transplant.,"BACKGROUND Left ventricular assist device (LVAD) implantation may improve kidney function, but in patients awaiting heart transplantation, the long-term effects of LVAD implantation on renal function and subsequent clinical outcome are unclear. MATERIAL AND METHODS We analyzed data in patients with LVAD implants (n=139) and without LVAD implants (n=1038) who were listed for a heart transplant at our institution between 2000 and 2019. The primary endpoint was an impairment in renal function (decrease of creatinine-based estimated glomerular filtration rate [eGFR] by ≥30%) up to a maximum of 2 years after listing. Secondary endpoints were chronic kidney disease stage 4 or 5, heart transplantation, survival during listing, and 1-year survival after transplantation. RESULTS Values for eGFR increased after LVAD implantation (P=0.001) and were higher at the time of waitlisting in the LVAD group than in the non-LVAD group (P=0.002), but were similar between groups at the end of waitlisting (P=0.75). Two-year freedom from renal impairment was 50.6% and 66.7% in the LVAD and non-LVAD groups, respectively, with a multivariable-adjusted hazard ratio for the LVAD versus the non-LVAD group of 1.78 (95% confidence interval 1.19-2.68; P=0.005). Two-year freedom from chronic kidney disease stages 4-5 was similar between study groups (LVAD group: 83.5%; non-LVAD group: 80.1%; =0.50). The 2-year probability of transplantation was slightly lower in the LVAD group than in the non-LVAD group (50.0% and 55.8%, respectively, P=0.017). However, 2-year survival on the waiting list and 1-year survival after transplantation did not differ significantly between study groups (P-values >0.20). CONCLUSIONS Our data indicate a transient improvement in creatinine-based eGFR values by LVAD implantation without influencing survival.",2020,"The 2-year probability of transplantation was slightly lower in the LVAD group than in the non-LVAD group (50.0% and 55.8%, respectively, P=0.017).","['Patients with or without a Left Ventricular Assist Device Implant', 'patients with LVAD implants (n=139) and without LVAD implants (n=1038) who were listed for a heart transplant at our institution between 2000 and 2019', 'patients awaiting heart transplantation']","['Left ventricular assist device (LVAD) implantation', 'LVAD', 'LVAD implantation']","['Renal Function', 'creatinine-based eGFR values', 'impairment in renal function (decrease of creatinine-based estimated glomerular filtration rate [eGFR', '2-year survival on the waiting list and 1-year survival', 'chronic kidney disease stage 4 or 5, heart transplantation, survival during listing, and 1-year survival', '2-year probability of transplantation', 'renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",,0.0988718,"The 2-year probability of transplantation was slightly lower in the LVAD group than in the non-LVAD group (50.0% and 55.8%, respectively, P=0.017).","[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Zittermann', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Schramm', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'von Rössing', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Hinse', 'Affiliation': 'Institute of Laboratory and Transfusion Medicine, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wlost', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Morshuis', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Gummert', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Fuchs', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia (NRW), Ruhr University Bochum, Bad Oeynhausen, Germany.'}]",Annals of transplantation,['10.12659/AOT.925653']
1624,33168910,"An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2).","New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1-72%; 1/5) and in the standard treatment arm was 100% (95% CI 54-100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.",2020,"Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1-72%; 1/5) and in the standard treatment arm was 100% (95% CI 54-100%; 6/6).","['oropharyngeal gonorrhoea', 'Twelve men', 'men with untreated oropharyngeal gonorrhoea that was conducted between September 2018\xa0and February 2020\xa0at Melbourne Sexual Health Centre in Australia']","['standard treatment (antibiotic', 'mouthwash (n\u2009=\u20096) or standard treatment', 'intervention (rinsing, gargling and spraying mouthwash twice daily for 14\xa0days) or control (standard treatment', 'antiseptic mouthwash versus\xa0antibiotics']","['detection of oropharyngeal N. gonorrhoeae by NAAT', 'cure rate for oropharyngeal gonorrhoea']","[{'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0027573', 'cui_str': 'Neisseria gonorrhoeae'}, {'cui': 'C0200932', 'cui_str': 'Nucleic acid amplification'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}]",,0.197725,"Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1-72%; 1/5) and in the standard treatment arm was 100% (95% CI 54-100%; 6/6).","[{'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia. eric.chow@monash.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maddaford', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Hocking', 'Affiliation': 'Melbourne School of Population and Global Health, The University of Melbourne, Carlton, VIC, Australia.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Bradshaw', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wigan', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Marcus Y', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Howden', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia.'}]",Scientific reports,['10.1038/s41598-020-76184-1']
1625,33144141,Control of cardiovascular risk factors with tailored recommendations: A randomized controlled trial.,"This study analyzed the efficacy of tailored recommendations to control cardiovascular risk factors at 1-year follow-up in a population-based randomized controlled trial in individuals aged 35-74 years with no history of cardiovascular disease at baseline. Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP) were measured at baseline and at 1-year follow-up. The primary outcome was the quantitative change in total cholesterol. To estimate the differences within and between groups, McNemar and Student t-tests were applied according to an intention-to-treat strategy. We enrolled 955 individuals [52.3% women; mean age, 50 years (standard deviation 10)]. Finally, 1 participant in each group presented a cardiovascular event and 768 were reexamined at 1-year follow-up. Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively]. Men in the intervention group showed significant decreases in systolic and diastolic BP [117.2 (14.6) to 115.6 mmHg (14.1) and 77.9 (9.7) to 76.5 mmHg (9.7), respectively]; no changes were found in the rates of total cholesterol <5.2 mmol/L and LDL cholesterol <3.0 mmol/L. In the control group, both values were significantly decreased (43.5 to 36.4% and 26.4 to 20.8%, respectively) in men. In the stratified analysis, women showed no differences in any of the outcomes. In conclusion, an intervention with tailored recommendations increased mean total cholesterol values. The intervention effect was higher in men who maintained blood lipids at optimal levels and had decreased BP values.",2020,"Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively].","['We enrolled 955 individuals [52.3% women; mean age, 50\u202fyears (standard deviation 10', 'individuals aged 35-74\u202fyears with no history of cardiovascular disease at baseline']",[],"['systolic and diastolic BP', 'total cholesterol', 'rates of total cholesterol', 'Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP', 'cardiovascular event', 'BP values', 'quantitative change in total cholesterol', 'mean total cholesterol values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",955.0,0.122144,"Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively].","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Barroso', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Department of Pediatrics, Obstetrics, Gynecology and Preventive Medicine, School of Medicine, Autonomous University of Barcelona, Spain; Eastfield Health, Ashburton, New Zealand.'}, {'ForeName': 'M Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; School of Health Sciences, Blanquerna-Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Díaz', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Docent Unit Preventive Medicine and Public Health Parc de Salut Mar, Barcelona Public Health Agency, Pompeu-Fabra University, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Fernández', 'Affiliation': 'Regicor Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Cardiovascular Disease (CIBERCV), Barcelona, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Martí-Lluch', 'Affiliation': 'ISV Girona, IDIAP Jordi Gol, Girona, Catalunya, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cordón', 'Affiliation': 'Primary Care Services, Catalan Institute of Health, Girona, Catalunya, Spain; Department of Medical Sciences, School of Medicine, University of Girona, Spain.'}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Ramos', 'Affiliation': 'ISV Girona, IDIAP Jordi Gol, Girona, Catalunya, Spain; Department of Medical Sciences, School of Medicine, University of Girona, Spain; Girona Biomedical Research Institute, Girona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cabezas', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Salvador', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Conxa', 'Initials': 'C', 'LastName': 'Castell', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Grau', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Barcelona, Spain; Serra Húnter Fellow, Department of Medicine, University of Barcelona, Barcelona, Spain. Electronic address: mgrau@imim.es.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106302']
1626,33146620,Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM.
OBJECTIVE


We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM.
METHODS


Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet.
RESULTS


A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02).
CONCLUSIONS


Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women's diet.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729.",2020,The control group reported a higher weekly frequency of choosing fish meals (P=.05).,"['A total of 238 women participated: 115', '238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36', 'Women With Gestational Diabetes Mellitus', 'Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017', 'Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L', 'gestational diabetes mellitus (GDM']","['smartphone app with targeted dietary information and blood glucose monitoring', 'intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only', 'Pregnant+ Smartphone App']","['Dietary Behavior', 'non-Norwegian language as their first language']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0557073', 'cui_str': 'First language'}]",238.0,0.102724,The control group reported a higher weekly frequency of choosing fish meals (P=.05).,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Garnweidner-Holme', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Henriksen', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}, {'ForeName': 'Liv Elin', 'Initials': 'LE', 'LastName': 'Torheim', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Lukasse', 'Affiliation': 'OsloMet - Oslo Metropolitan University of Applied Sciences, Oslo, Norway.'}]",JMIR mHealth and uHealth,['10.2196/18614']
1627,33146624,"Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence for Elderly, Post-Myocardial Infarction Patients: Protocol for an Interrupted Time Series Study.","BACKGROUND


Based on high-quality evidence, guidelines recommend the long-term use of secondary prevention medications post-myocardial infarction (MI) to avoid recurrent cardiovascular events and death. Unfortunately, discontinuation of recommended medications post-MI is common. Observational evidence suggests that prescriptions covering a longer duration at discharge from hospital are associated with greater long-term medication adherence. The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
OBJECTIVE


The overarching goal of this study is to reduce morbidity and mortality among post-MI patients through improved long-term cardiac medication adherence. The specific objectives include the following. First, we will assess whether long-term cardiac medication adherence improves among elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in combination with education and (2) education alone compared to (3) usual care. Second, we will assess the cost implications of prolonged initial discharge prescriptions compared with usual care. Third, we will compare clinical outcomes between longer (>60 days) versus shorter prescription durations. Fourth, we will collect baseline information to inform a multicenter interventional study.
METHODS


We will conduct a quasiexperimental, interrupted time series design to evaluate the impact of a multifaceted intervention to implement longer duration prescriptions versus usual care on long-term cardiac medication adherence among post-MI patients. Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days' worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care). Administrative databases will be used to measure all outcomes. Adherence to 4 classes of cardiac medications - statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor) - will be assessed.
RESULTS


Enrollment began in September 2017, and results are expected to be analyzed in late 2020.
CONCLUSIONS


The results have the potential to redefine best practices regarding discharge prescribing policies for patients post-MI. A policy of standardized maximum-duration prescriptions at the time of discharge post-MI is a simple intervention that has the potential to significantly improve long-term medication adherence, thus decreasing cardiac morbidity and mortality. If effective, this low-cost intervention to implement longer duration prescriptions post-MI could be easily scaled.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03257579; https://clinicaltrials.gov/ct2/show/NCT03257579.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18981.",2020,"The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
","['Elderly, Post-Myocardial Infarction Patients', 'post-MI patients', 'elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in']","['combination with education and (2) education alone compared to (3) usual care', ""Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days' worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care"", 'cardiac medications - statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor']","['morbidity and mortality', 'Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence', 'cardiac morbidity and mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",,0.110536,"The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
","[{'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Ivers', 'Affiliation': ""Family Practice Health Centre, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Madhu K', 'Initials': 'MK', 'LastName': 'Natarajan', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'ICES, Toronto, ON, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McCready', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': ""O'Brien"", 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.'}]",JMIR research protocols,['10.2196/18981']
1628,33147543,The influence of age on spinal and lower limb muscle activity during repetitive lifting.,"This study investigated the effects of age on upper erector spinae (UES), lower erector spinae (LES) and lower body (gluteus maximus; biceps femoris; and vastus lateralis) muscle activity during a repetitive lifting task. Twenty-four participants were assigned to two age groups: 'younger' (n = 12; mean age ± SD = 24.6 ± 3.6 yrs) and 'older' (n = 12; mean age = 46.5 ± 3.0 yrs). Participants lifted and lowered a box (13 kg) repetitively at a frequency of 10 lifts per minute for a maximum of 20 min. EMG signals were collected every minute and normalised to a maximum voluntary isometric contraction. A submaximal endurance test of UES and LES was used to assess fatigue. Older participants showed higher levels of UES and LES muscle activity (approximately 12-13%) throughout the task, but less fatigue compared to the younger group post-task completion. When lifting, lower-limb muscle activity was generally higher in older adults, although temporal changes were similar. While increased paraspinal muscle activity may increase the risk of back injury in older workers when repetitive lifting, younger workers may be more susceptible to fatigue-related effects. Education and training in manual materials handling should consider age-related differences when developing training programmes.",2020,"Older participants showed higher levels of UES and LES muscle activity (approximately 12-13%) throughout the task, but less fatigue compared to the younger group post-task completion.","[""Twenty-four participants were assigned to two age groups: 'younger' (n\xa0=\xa012; mean age\xa0±\xa0SD\xa0=\xa024.6\xa0±\xa03.6 yrs) and 'older' (n\xa0=\xa012; mean age\xa0=\xa046.5\xa0±\xa03.0 yrs"", 'Older participants']",['UES and LES'],"['paraspinal muscle activity', 'levels of UES and LES muscle activity', 'lower-limb muscle activity', 'upper erector spinae (UES), lower erector spinae (LES) and lower body (gluteus maximus; biceps femoris; and vastus lateralis) muscle activity', 'fatigue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0448353', 'cui_str': 'Deep muscle of back'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0224449', 'cui_str': 'Biceps femoris muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",24.0,0.0286904,"Older participants showed higher levels of UES and LES muscle activity (approximately 12-13%) throughout the task, but less fatigue compared to the younger group post-task completion.","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Boocock', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, New Zealand. Electronic address: mark.boocock@aut.ac.nz.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, New Zealand.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Mawston', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, New Zealand.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102482']
1629,33148013,Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial.,"Background The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) demonstrated noninferiority of once-daily 60 mg (30 mg dose-reduced) edoxaban compared with warfarin for prevention of stroke/systemic embolism in patients with atrial fibrillation. No previous analysis has explored the impact of treatment with edoxaban versus warfarin on rates of hospitalizations. Methods Detailed healthcare resource utilization data from ENGAGE AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug were used to compare the rates of bleeding- and cardiovascular-related hospitalizations for edoxaban versus warfarin. Hospitalization rates were calculated for each treatment group, and relative rates were estimated using Poisson regression. The influence of patient characteristics on the impact of edoxaban versus warfarin was evaluated through the inclusion of interaction terms. Results The overall rate of cardiovascular- or bleeding-related hospitalization was significantly lower for edoxaban than warfarin (relative rate [RR], 0.91 [95% CI, 0.85-0.97],  P =0.003). Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97],  P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88],  P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99],  P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68],  P <0.0001) were also lower for edoxaban. Notably, significantly greater reductions with edoxaban versus warfarin were seen for ischemic stroke-related hospitalizations in vitamin K antagonist naive patients and patients with CHADS 2  scores 4 to 6, previous stroke or transient ischemic attack, age ≥75, and no previous coronary artery disease. For nonstroke bleeding-related hospitalizations, greater reductions with edoxaban were seen in vitamin K antagonist naive patients, patients with CHADS 2  scores 4 to 6, and patients with moderate renal dysfunction. Conclusions Edoxaban 60 mg (30 mg dose-reduced) was associated with a significantly lower overall rate of cardiovascular- or bleeding-related hospitalization and significant reductions in the subcategories of cardiovascular-related, stroke-related, bleed-related, and nonstroke cardiovascular-related hospitalizations, when compared with warfarin. These results suggest the potential for cost offsets with edoxaban, with even greater reductions in higher-risk patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781391.",2020,"Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97],  P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88],  P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99],  P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68],  P <0.0001) were also lower for edoxaban.","['patients with atrial fibrillation', 'AF-TIMI 48 for the 14 024 randomized patients who received at least one dose of study drug', 'Patients With Atrial Fibrillation']","['Conclusions Edoxaban', 'edoxaban', 'edoxaban versus warfarin', 'warfarin', 'Edoxaban Versus Warfarin']","['Cardiovascular- and Bleeding-Related Hospitalization Rates', 'ischemic stroke-related hospitalizations', 'Hospitalization rates', 'rates of hospitalizations', 'rates of bleeding- and cardiovascular-related hospitalizations', 'stroke', 'overall rate of cardiovascular- or bleeding-related hospitalization', 'Rates of hospitalizations for cardiovascular reasons']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",14024.0,0.325494,"Rates of hospitalizations for cardiovascular reasons (RR, 0.91 [95% CI, 0.85-0.97],  P =0.004), stroke (RR, 0.80 [95% CI, 0.72-0.88],  P <0.0001), and for each stroke subtype (ischemic: RR, 0.89 [95% CI, 0.81-0.99],  P =0.03; hemorrhagic: RR, 0.60 [95% CI, 0.54-0.68],  P <0.0001) were also lower for edoxaban.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Vilain', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Wingham J', 'Initials': 'WJ', 'LastName': 'Kwong', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ (W.J.K.).'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO (K.V., H.L., E.A.M.).""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine (D.J.C., E.A.M.).'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Boston, MA (E.M.A., C.T.R., E.B., R.P.G.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': 'University of Missouri-Kansas City School of Medicine (D.J.C., E.A.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006511']
1630,33148502,Respiratory sinus arrhythmia biofeedback alters heart rate variability and default mode network connectivity in major depressive disorder: A preliminary study.,"Traditional major depressive disorder (MDD) interventions do not improve heart rate variability (HRV), despite symptom reduction. We investigated whether respiratory sinus arrhythmia (RSA)-biofeedback (BFB) effectively changed HRV, psychological symptoms, and functional connectivity of the default mode network (DMN), which is known to increase in MDD. Thirty MDD patients were randomly assigned to two groups (RSA-BFB with treatment as usual [TAU] with medication [BFB + TAU; n = 16] and TAU [n = 14]). Six RSA-BFB sessions were performed over 4 weeks. We assessed psychological symptoms (including depression, anxiety, and hopelessness), high frequency (HF; an index of HRV during rest and stress), and DMN functional connectivity, as measured by source-level coherence of 19-channel electroencephalography using standardized weighted low-resolution brain electromagnetic tomography. Large-scale DMN was represented by small-worldness based on graph theory. The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group. Significant group by session interactions were found in resting HF-HRV, stress-reactive HF-HRV, and beta DMN small-worldness. During the post-intervention session, the BFB + TAU group showed higher resting HF-HRV and stress-reactive HF-HRV (d = 1.41 for the resting stage and d = 1.99 for the Stroop test, P < .005). Compared to baseline, the BFB + TAU group showed increased HF-HRV reactivity and decreased DMN small-worldness in the beta band, implying decreased global DMN functional connectivity. Conversely, the TAU group showed decreased HF-HRV during stress and no DMN alterations. This study was limited by small sample size and open-label design. These preliminary findings suggest that brief RSA-BFB may improve autonomic nervous system and DMN functions in MDD.",2020,The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group.,"['Thirty MDD patients', 'major depressive disorder']","['RSA-BFB', 'RSA-BFB with treatment as usual [TAU] with medication [BFB\xa0+\xa0TAU; n\xa0=\xa016] and TAU', 'TAU', 'respiratory sinus arrhythmia (RSA)-biofeedback (BFB']","['HF-HRV reactivity', 'resting HF-HRV, stress-reactive HF-HRV, and beta DMN small-worldness', 'heart rate variability (HRV', 'psychological symptoms (including depression, anxiety, and hopelessness), high frequency (HF; an index of HRV during rest and stress), and DMN functional connectivity, as measured by source-level coherence of 19-channel electroencephalography', 'global DMN functional connectivity', 'HF-HRV', 'resting HF-HRV and stress-reactive HF-HRV', 'depression (especially psychic anxiety and vegetative symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.0595873,The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group.,"[{'ForeName': 'Su Mi', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; Department of Clinical Medical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; Department of Clinical Medical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry and Behavioral Science and Institute of Human Behavioral Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hyjung@snu.ac.kr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.008']
1631,33151775,Ascorbate attenuates cycling exercise-induced neuromuscular fatigue but fails to improve exertional dyspnea and exercise tolerance in COPD.,"We examined the effect of intravenous ascorbate administration (VitC) on exercise-induced redox balance, inflammation, exertional dyspnea, neuromuscular fatigue, and exercise tolerance in patients with chronic obstructive pulmonary disease (COPD). Eight COPD patients completed constant-load cycling (~80% of peak power output, 83±10W) to task-failure following intravenous VitC (2g) or saline (placebo, PL) infusion. All participants repeated the shorter of the two exercise trials (isotime), with the other infusate. Quadriceps fatigue was determined by pre- to post-exercise changes in quadriceps twitch-torque (∆Q tw , electrical femoral nerve stimulation). Corticospinal excitability before, during, and after exercise was assessed by changes in motor-evoked potentials triggered by transcranial magnetic stimulation. VitC increased superoxide dismutase (marker for endogenous antioxidant capacity) by 129% and mitigated C-reactive protein (marker for inflammation) in the plasma during exercise, but failed to alter the exercise-induced increase in lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy). While VitC did, indeed, decrease neuromuscular fatigue (∆Q tw  PL: -29±5%, VitC: -23±6%, P<0.05), there was no impact on corticospinal excitability and time to task-failure (~8min, P=0.8). Interestingly, in terms of pulmonary limitations to exercise, VitC had no effect on perceived exertional dyspnea (~8.5/10) and its determinants, including S p O 2  (~92%) and respiratory muscle work (~650cmH 2 OŸsŸmin -1 ) (P>0.3). Thus, although VitC facilitated indicators for antioxidant capacity, diminished inflammatory markers, and improved neuromuscular fatigue resistance, it failed to improve exertional dyspnea and cycling exercise tolerance in patients with COPD. As dyspnea is recognized to limit exercise tolerance in COPD, the otherwise beneficial effects of VitC may have been impacted by this unaltered sensation.",2020,"VitC increased superoxide dismutase (marker for endogenous antioxidant capacity) by 129% and mitigated C-reactive protein (marker for inflammation) in the plasma during exercise, but failed to alter the exercise-induced increase in lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy).","['Eight COPD patients completed', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD']","['intravenous VitC (2g) or saline (placebo, PL) infusion', 'intravenous ascorbate administration (VitC']","['superoxide dismutase', 'exertional dyspnea and exercise tolerance', 'lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy', 'exertional dyspnea and cycling exercise tolerance', 'Quadriceps fatigue', 'exertional dyspnea', 'neuromuscular fatigue ', 'quadriceps twitch-torque (∆Q tw , electrical femoral nerve stimulation', 'neuromuscular fatigue resistance', 'corticospinal excitability and time to task-failure', 'constant-load cycling', 'exercise-induced redox balance, inflammation, exertional dyspnea, neuromuscular fatigue, and exercise tolerance', 'Corticospinal excitability']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0201898', 'cui_str': 'Ascorbic acid measurement'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0015808', 'cui_str': 'Structure of femoral nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",8.0,0.0886949,"VitC increased superoxide dismutase (marker for endogenous antioxidant capacity) by 129% and mitigated C-reactive protein (marker for inflammation) in the plasma during exercise, but failed to alter the exercise-induced increase in lipid peroxidation (malondialdehyde) and free radicals (EPR-spectroscopy).","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'Department of Medicine, University of Strasbourg, France.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Weavil', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, University of Utah, United States.'}, {'ForeName': 'Simranjit K', 'Initials': 'SK', 'LastName': 'Sidhu', 'Affiliation': 'School of Medicine, University of Adelaide, Australia.'}, {'ForeName': 'Taylor S', 'Initials': 'TS', 'LastName': 'Thurston', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, United States.'}, {'ForeName': 'Van R', 'Initials': 'VR', 'LastName': 'Reese', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Nelson', 'Affiliation': 'Pulmonary and Critical Care, University of Utah, United States.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Birgenheier', 'Affiliation': 'Department of Anesthesiology, University of Utah, United States.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Amann', 'Affiliation': 'Department of Internal Medicine, University of Utah, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00611.2020']
1632,33152354,Preclinical neurorehabilitation with environmental enrichment confers cognitive and histological benefits in a model of pediatric asphyxial cardiac arrest.,"Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities that affect overall quality of life, yet rehabilitation is neither routinely nor systematically provided. Environmental enrichment (EE) is considered a preclinical model of neurorehabilitation and thus we sought to investigate its efficacy in our established model of pediatric ACA. Male Sprague-Dawley rat pups (post-natal day 16-18) were randomly assigned to ACA (9.5 min) or Sham injury. After resuscitation, the rats were assigned to 21 days of EE or standard (STD) housing during which time motor, cognitive, and anxiety-like (i.e., affective) outcomes were assessed. Hippocampal CA 1  cells were quantified on post-operative day-22. Both ACA + STD and ACA + EE performed worse on beam-balance vs. Sham controls (p < 0.05) and did not differ from one another overall (p > 0.05); however, a single day analysis on the last day of testing revealed that the ACA + EE group performed better than the ACA + STD group (p < 0.05) and did not differ from the Sham controls (p > 0.05). Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test. Spatial learning and declarative memory were improved and CA 1  neuronal loss was attenuated in the ACA + EE vs. ACA + STD group (p < 0.05). Collectively, the data suggest that providing rehabilitation after pediatric ACA can reduce histopathology and improve motor and cognitive ability.",2020,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"['Male Sprague-Dawley rat pups (post-natal day 16-18', 'Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities']","['Environmental enrichment (EE', 'ACA']","['motor and cognitive ability', 'CA 1  neuronal loss', 'Spatial learning and declarative memory']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0463264,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"[{'ForeName': 'Mioara D', 'Initials': 'MD', 'LastName': 'Manole', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: manomd@upmc.edu.'}, {'ForeName': 'Marcus J A', 'Initials': 'MJA', 'LastName': 'Hook', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; University of Bath, Claverton Down, Bath BA2 7AY, UK.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Nicholas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Brittany P', 'Initials': 'BP', 'LastName': 'Nelson', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Adanna C', 'Initials': 'AC', 'LastName': 'Liu', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Quinn C', 'Initials': 'QC', 'LastName': 'Stezoski', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Rowley', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Cheng', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Alexander', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Eleni H', 'Initials': 'EH', 'LastName': 'Moschonas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Corina O', 'Initials': 'CO', 'LastName': 'Bondi', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Neurobiology, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Kline', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for the Neural Basis of Cognition, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: klineae@upmc.edu.'}]",Experimental neurology,['10.1016/j.expneurol.2020.113522']
1633,33157308,"Esophageal balloon calibration during Sigh: A physiologic, randomized, cross-over study.","PURPOSE


Optimal esophageal balloon filling volume (V best ) depends on the intrathoracic pressure. During Sigh breath delivered by the ventilator machine, esophageal balloon is surrounded by elevated intrathoracic pressure that might require higher filling volume for accurate measure of tidal changes in esophageal pressure (Pes). The primary aim of our investigation was to evaluate and compare V best  during volume controlled and pressure support breaths vs. Sigh breath.
MATERIALS AND METHODS


Twenty adult patients requiring invasive volume-controlled ventilation (VCV) for hypoxemic acute respiratory failure were enrolled. After the insertion of a naso-gastric catheter equipped with 10 ml esophageal balloon, each patient underwent three 30-min trials as follows: VCV, pressure support ventilation (PSV), and PSV + Sigh. Sigh was added to PSV as 35 cmH 2 O pressure-controlled breath over 4 s, once per minute. PSV and PSV + Sigh were randomly applied and, at the end of each step, esophageal balloon calibration was performed.
RESULTS


V best  was higher for Sigh breath (4.5 [3.0-6.8] ml) compared to VCV (1.5 [1.0-2.9] ml, P = 0.0004) and PSV tidal breath (1.0 [0.5-2.4] ml, P < 0.0001).
CONCLUSIONS


During Sigh breath, applying a calibrated approach for Pes assessment, a higher V best  was required compared to VCV and PSV tidal breath.",2020,"RESULTS


V best  was higher for Sigh breath (4.5 [3.0-6.8] ml) compared to VCV","['hypoxemic acute respiratory failure were enrolled', 'Twenty adult patients requiring']","['VCV, pressure support ventilation (PSV), and PSV\xa0+\xa0Sigh', 'VCV', 'invasive volume-controlled ventilation (VCV']","['PSV tidal breath', 'Sigh breath']","[{'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0425481', 'cui_str': 'Sighing respiration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0425481', 'cui_str': 'Sighing respiration'}]",20.0,0.099474,"RESULTS


V best  was higher for Sigh breath (4.5 [3.0-6.8] ml) compared to VCV","[{'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Anesthesia and General Intensive Care, ""Maggiore della Carità"" University Hospital, Novara, Italy. Electronic address: gmcamma@gmail.com.'}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Santangelo', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Lauro', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Verdina', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Boniolo', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Nello', 'Initials': 'N', 'LastName': 'De Vita', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Tarquini', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Medical and Surgical Science, Università Magna Greacia, Catanzaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Department of Medical and Surgical Science, Università Magna Greacia, Catanzaro, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zanoni', 'Affiliation': 'Anesthesia and General Intensive Care, ""Maggiore della Carità"" University Hospital, Novara, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Messina', 'Affiliation': 'Humanitas Clinical and Research Center - IRCCS - Rozzano, Milano, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Francesco Della', 'Initials': 'FD', 'LastName': 'Corte', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Department of Medicine, University of Padua, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Vaschetto', 'Affiliation': 'Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Journal of critical care,['10.1016/j.jcrc.2020.10.021']
1634,33157963,Clinical observation of the combined use of propofol and etomidate in painless gastroscopy.,"OBJECTIVE


This study is aims to compare the anesthetic safety of propofol combined with etomidate for painless gastroscopy.
METHODS


Three hundred patients undergoing painless gastroscopy were randomly assigned to P, PE1, and PE2 groups. Patients were anesthetized with propofol (P group) or propofol combined with etomidate (volume ratio 1: 1, PE1 group; volume ratio 2: 1, PE2 group). The hemodynamics and adverse reactions were observed. The sleep quality satisfaction and nature of dreams were recorded.
RESULTS


Compared with pre-anesthesia, the mean arterial pressure and heart rate of the 3 groups were significantly slower during the examination and at the end of the examination. PE1 group had a higher incidence of muscle spasm, body moving, choking, and deglutition. The incidence of hypoxemia and injection pain was higher in P group. P and PE2 group had higher sleep quality satisfaction and dream incidence after awaking. However, there was no difference in the nature of dreams among 3 groups.
CONCLUSION


Our data indicate that the combination of 10 ml 1.0% propofol and 5 ml 0.2% etomidate for painless gastroscopy reduces adverse reactions while not affecting the patients respiratory function. Moreover, it is safe and effective, which is worthy of clinical application and promotion.",2020,"Compared with pre-anesthesia, the mean arterial pressure and heart rate of the 3 groups were significantly slower during the examination and at the end of the examination.","['Three hundred patients undergoing painless gastroscopy', 'painless gastroscopy']","['propofol and etomidate', 'propofol', 'PE1', 'propofol combined with etomidate']","['muscle spasm, body moving, choking, and deglutition', 'incidence of hypoxemia and injection pain', 'sleep quality satisfaction', 'adverse reactions', 'hemodynamics and adverse reactions', 'anesthetic safety', 'sleep quality satisfaction and nature of dreams', 'nature of dreams', 'mean arterial pressure and heart rate']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015131', 'cui_str': 'Etomidate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",300.0,0.0328939,"Compared with pre-anesthesia, the mean arterial pressure and heart rate of the 3 groups were significantly slower during the examination and at the end of the examination.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, 1st Swan lake road, Shushan District, Hefei, Anhui Province, China.'}, {'ForeName': 'Xibei', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Bingqing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Wanhong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Kang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023061']
1635,33158369,Exacerbations of asthma following step-up and step-down inhaled corticosteroid and long acting beta agonist therapy in the managing asthma in pregnancy study.,"OBJECTIVE


Guidelines for asthma management contain a consensus recommendation that inhaled corticosteroid (ICS) dose should not be stepped down in pregnancy. However, this is not consistent with consumer preferences and pharmacological principles to minimize medication exposure during pregnancy. We investigated exacerbations after changes to ICS and long acting beta agonist (LABA) therapy in pregnant women with asthma.
METHODS


Pregnant women ( n  = 220) were recruited to a randomized controlled trial (RCT) where maintenance treatment was adjusted monthly based on either symptoms (control group), or fractional exhaled nitric oxide (FeNO, to alter ICS) and symptoms (to alter LABA, FeNO group). Exacerbations were monitored prospectively.
RESULTS


ICS were used by 137 (62.3%) women at some time during pregnancy. ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7-18%), increased in 37 women (27%, 95%CI 20-35%), decreased in 34 women (24.8%, 95%CI 18%-33%), or both increased and decreased in 50 women (36.5%, 95%CI 29-45%). Exacerbations occurred within 14 days of ICS step-down in 11 women (13%, 95%CI 7.5%-22%). This was not significantly different from exacerbations occurring within 14 days of step-up, in 7 women (8.1%, 95%CI 4%-16%,  P  = 0.294). There were no differences between management groups. Exacerbations occurred within 14 days of step-down in 14.7% (95%CI 7%-30%) of women in the control group, and in 12% (95%CI 6%-24%) of women in the FENO group.
CONCLUSIONS


ICS step-down could be considered when eosinophilic inflammation or symptoms are low, and may be a useful management approach for women, doctors, and midwives wishing to minimize ICS exposure during pregnancy.",2020,"ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7-18%), increased in 37 women (27%, 95%CI 20-35%), decreased in 34 women (24.8%, 95%CI 18%-33%), or both increased and decreased in 50 women (36.5%, 95%CI 29-45%).","['pregnant women with asthma', 'Pregnant women (n\u2009=\u2009220']","['step-up and step-down inhaled corticosteroid and long acting beta agonist therapy', 'inhaled corticosteroid (ICS', 'ICS and long acting beta agonist (LABA) therapy']","['ICS', 'Exacerbations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",220.0,0.535785,"ICS dose remained unchanged in 16 women (11.7%, 95% confidence interval [CI] 7-18%), increased in 37 women (27%, 95%CI 20-35%), decreased in 34 women (24.8%, 95%CI 18%-33%), or both increased and decreased in 50 women (36.5%, 95%CI 29-45%).","[{'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Murphy', 'Affiliation': 'Priority Research Centre GrowUpWellTM, University of Newcastle and Hunter Medical Research Institute, Callaghan, NSW, Australia.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Jensen', 'Affiliation': 'Priority Research Centre GrowUpWellTM, University of Newcastle and Hunter Medical Research Institute, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'Priority Research Centre for Healthy Lungs, University of Newcastle and Hunter Medical Research Institute, New Lambton, NSW, Australia.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1847934']
1636,33158819,Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY.,"INTRODUCTION


Smoking prior to major thoracic surgery is the biggest risk factor for development of postoperative pulmonary complications, with one in five patients continuing to smoke before surgery. Current guidance is that all patients should stop smoking before elective surgery yet very few are offered specialist smoking cessation support. Patients would prefer support within the thoracic surgical pathway. No study has addressed the effectiveness of such an intervention in this setting on cessation. The overall aim is to determine in patients who undergo major elective thoracic surgery whether an intervention integrated (INT) into the surgical pathway improves smoking cessation rates compared with usual care (UC) of standard community/hospital based NHS smoking support. This pilot study will evaluate feasibility of a substantive trial.
METHODS AND ANALYSIS


Project MURRAY is a trial comparing the effectiveness of INT and UC on smoking cessation. INT is pharmacotherapy and a hybrid of behavioural support delivered by the trained healthcare practitioners (HCPs) in the thoracic surgical pathway and a complimentary web-based application. This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust. The primary objective is to establish the proportion of those eligible who agree to participate. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.
ETHICS AND DISSEMINATION


The study has obtained ethical approval from NHS Research Ethics Committee (REC number 19/WM/0097). Dissemination plan includes informing patients and HCPs; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full application dependent on the success of the study.
TRIAL REGISTRATION NUMBER


NCT04190966.",2020,This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust.,"['patients who undergo major elective thoracic surgery whether an', 'five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust']","['intervention integrated (INT', 'INT and UC', 'usual care (UC) of standard community/hospital based NHS smoking support', 'smoking cessation', 'Smoking prior to major thoracic surgery']",['smoking cessation rates'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0523317,This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust.,"[{'ForeName': 'Sebastian T', 'Initials': 'ST', 'LastName': 'Lugg', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kerr', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Kadiri', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Alina-Maria', 'Initials': 'AM', 'LastName': 'Budacan', 'Affiliation': 'Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Insitute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Perski', 'Affiliation': 'Institute of Epidemiology & Health, University College London, London, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Institute of Epidemiology & Health, University College London, London, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Institute of Epidemiology & Health, University College London, London, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thickett', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Babu', 'Initials': 'B', 'LastName': 'Naidu', 'Affiliation': 'Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK b.naidu@bham.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036568']
1637,33159526,Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial.,"Importance


Reduction of subsequent disabling stroke is the main goal of preventive treatment in the acute setting after transient ischemic attack (TIA) or minor ischemic stroke.
Objective


To evaluate the superiority of ticagrelor added to aspirin in preventing disabling stroke and to understand the factors associated with recurrent disabling stroke.
Design, Setting, and Participants


The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) was a randomized clinical trial conducted between January 22, 2018, and December 13, 2019, with a 30-day follow-up, at 414 hospitals in 28 countries. The trial included 11 016 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk TIA, including 10 803 with modified Rankin Scale score (mRS) recorded at 30 days.
Interventions


Ticagrelor (180-mg loading dose on day 1 followed by 90 mg twice daily for days 2-30) or placebo within 24 hours of symptom onset. All patients received aspirin, 300 to 325 mg on day 1 followed by 75 to 100 mg daily for days 2 to 30.
Main Outcomes and Measures


Time to the occurrence of disabling stroke (progression of index event or new stroke) or death within 30 days, as measured by mRS at day 30. Disabling stroke was defined by mRS greater than 1.
Results


Among participants with 30-day mRS greater than 1, mean age was 68.1 years, 1098 were female (42.6%), and 2670 had an ischemic stroke (95.8%) as a qualifying event. Among 11 016 patients, a primary end point with mRS greater than 1 at 30 days occurred in 221 of 5511 patients (4.0%) randomized to ticagrelor and in 260 of 5478 patients (4.7%) randomized to placebo (hazard ratio [HR], 0.83; 95% CI, 0.69-0.99, P = .04). A primary end point with mRS 0 or 1 at 30 days occurred in 70 of 5511 patients (1.3%) and 87 of 5478 patients (1.6%) (HR, 0.79; 95% CI, 0.57-1.08; P = .14). The ordinal analysis of mRS in patients with recurrent stroke showed a shift of the disability burden following a recurrent ischemic stroke in favor of ticagrelor (odds ratio, 0.77; 95% CI, 0.65-0.91; P = .002). Factors associated with disability were baseline National Institutes of Health Stroke Scale score 4 to 5, ipsilateral stenosis of at least 30%, Asian race/ethnicity, older age, and higher systolic blood pressure, while treatment with ticagrelor was associated with less disability.
Conclusions and Relevance


In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.
Trial Registration


ClinicalTrials.gov Identifier: NCT03354429.",2020,"In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.
","['Disabling Stroke', ' mean age was 68.1 years, 1098 were female (42.6%), and 2670 had an ischemic stroke (95.8%) as a qualifying event', 'January 22, 2018, and December 13, 2019, with a 30-day follow-up, at 414 hospitals in 28 countries', '016 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk TIA, including 10\u202f803 with modified Rankin Scale score (mRS) recorded at 30 days', 'participants with 30-day mRS greater than 1']","['Ticagrelor', 'Ticagrelor and Aspirin', 'Aspirin', 'placebo', 'ticagrelor', 'aspirin']","['Acute Stroke or Transient Ischemic Attack', 'total burden of disability', 'disabling stroke', 'systolic blood pressure', 'disabling stroke or death', 'Disabling stroke', 'Measures\n\n\nTime to the occurrence of disabling stroke (progression of index event or new stroke) or death within 30 days, as measured by mRS']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",11016.0,0.293284,"In patients with TIA and minor ischemic stroke, ticagrelor added to aspirin was superior to aspirin alone in preventing disabling stroke or death at 30 days and reduced the total burden of disability owing to ischemic stroke recurrence.
","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Center, Bichat University Hospital, University of Paris, Paris, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': 'Biostatistics Center, The George Washington University, Washington, DC.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tiantan Hospital, Beijing, China.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, The University of Texas at Austin.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.4396']
1638,33156869,The association of primary aldosteronism with glaucoma-related fundus abnormalities.,"PURPOSE


To elucidate glaucoma-related fundus abnormalities in patients with primary aldosteronism (PA).
METHODS


The study compared 272 eyes from 137 PA patients and 352 eyes from 177 control subjects selected randomly from 1173 participants of a public glaucoma screening. The presence of glaucomatous optic disc appearance (rim thinning and cup enlargement) and retinal nerve fiber layer defects (RNFLDs) was determined independently from fundus photographs. The results were compared between the PA and control groups.
RESULTS


There were 9 patients (6.6%) with glaucomatous optic disc abnormalities in the PA group and 10 cases (5.6%) identified in the control group (p = 0.92). RNFLDs were detected more frequently in the PA group (55 eyes, 20.2%) than in the control group (26 eyes, 7.4%; p<0.001). The two types of RNFLDs were classified as either having their central ends at the disc margin (D) or away from the disc margin and around the retinal vessels (V). Type D and V RNFLDs were detected in 35 (12.9%) and 26 (9.6%) eyes in the PA group and in 25 (7.1%) and 4 (1.1%) eyes in the control group, respectively. Both types of RNFLDs were more frequent in the PA group than in the control group (Type D and V, p = 0.03, <0.001, respectively).
CONCLUSION


Although the prevalence of glaucomatous optic disc appearance did not differ between the two groups, RNFLDs were more frequent in PA patients than in the control group. Moreover, RNFLDs with their central ends located around retinal vessels were characteristic of PA patients.",2020,"Both types of RNFLDs were more frequent in the PA group than in the control group (Type D and V, p = 0.03, <0.001, respectively).
","['272 eyes from 137 PA patients and 352 eyes from 177 control subjects selected randomly from 1173 participants of a public glaucoma screening', 'patients with primary aldosteronism (PA']",[],"['glaucomatous optic disc appearance (rim thinning and cup enlargement) and retinal nerve fiber layer defects (RNFLDs', 'glaucomatous optic disc appearance', 'Type D and V RNFLDs', 'glaucomatous optic disc abnormalities']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C1384514', 'cui_str': 'Primary aldosteronism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0702254', 'cui_str': 'Glaucoma screening'}]",[],"[{'cui': 'C0029127', 'cui_str': 'Optic disc structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",1173.0,0.018529,"Both types of RNFLDs were more frequent in the PA group than in the control group (Type D and V, p = 0.03, <0.001, respectively).
","[{'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Ohshima', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Higashide', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Kimikazu', 'Initials': 'K', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Udagawa', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Department of Cardiovascular and Internal Medicine, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.'}]",PloS one,['10.1371/journal.pone.0242090']
1639,33170506,What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.,"BACKGROUND


Women of lower socioeconomic status (SES) with early-stage breast cancer are more likely to report poorer physician-patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices.
METHODS


We conducted a 3-arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon-level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence-based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre-consultation) to T5 (1-year after surgery.
RESULTS


Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self-reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety.
CONCLUSIONS


Paper-based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients.
LAY SUMMARY


The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices. Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text-only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education. Conversation aids with pictures and text helped women make better breast cancer surgery choices.",2020,"Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm.","['Women of lower socioeconomic status (SES) with early-stage breast cancer', 'women with lower incomes or less formal education to make breast cancer surgery choices', 'disadvantaged patients', 'breast cancer surgery conversation aids across socioeconomic strata', 'Sixteen surgeons saw 571 of 622 consented patients']","['Option Grid (text only) and Picture Option Grid (pictures plus text', 'Conversation aids with pictures and text']","['higher decision process scores (T2 and T3), better coordination of care', 'higher knowledge', 'concordance, treatment choice, or anxiety', 'observed SDM', 'Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care', 'improved decision process (T2 and T3), lower decision regret (T3), and more SDM']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",622.0,0.0857979,"Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm.","[{'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Renata W', 'Initials': 'RW', 'LastName': 'Yen', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schubbe', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Saunders', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Shubhada', 'Initials': 'S', 'LastName': 'Dhage', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Rosenkranz', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Margenthaler', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Anna N A', 'Initials': 'ANA', 'LastName': 'Tosteson', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Crayton', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Sherrill', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bradley', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Walling', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Marx', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Volk', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sepucha', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Ozanne', 'Affiliation': 'Department of Population Health Sciences, School of Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Percac-Lima', 'Affiliation': 'Massachusetts General Hospital Chelsea HealthCare Center, Chelsea, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bergin', 'Affiliation': 'Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Caity', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barth', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Aft', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Feldman', 'Affiliation': 'Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Cyr', 'Affiliation': 'Department of Surgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Christina V', 'Initials': 'CV', 'LastName': 'Angeles', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, New Hampshire.'}]",Cancer,['10.1002/cncr.33248']
1640,33172546,[Effectiveness of Saccharomyces boulardii combined with phototherapy in the treatment of hyperbilirubinemia in neonates: a prospective randomized controlled trial].,"OBJECTIVE


To study the effectiveness of Saccharomyces boulardii combined with phototherapy in the treatment of hyperbilirubinemia in neonates.
METHODS


The neonates with hyperbilirubinemia who were hospitalized from January to December 2018 were enrolled and randomly divided into an observation group (n=61) and a control group (n=63). The neonates in the observation group were treated with phototherapy combined with Saccharomyces boulardii, and those in the control group were treated with phototherapy combined with placebo. Treatment outcomes were compared between the two groups. Fecal samples were collected 72 hours after treatment and 16s rRNA high-throughput sequencing was used to compare the features of gut microbiota between the two groups.
RESULTS


There was no significant difference in the total serum bilirubin level between the two groups before treatment (P>0.05). At 24, 48, and 72 hours after treatment, the observation group had a significantly lower level of total serum bilirubin than the control group (P<0.05). Compared with the control group, the observation group had a significantly lower proportion of neonates requiring phototherapy again [20% (12/61) vs 75% (47/63), P<0.05]. Compared with the control group, the observation group had a significantly higher abundance of Bacteroides (P<0.05) and a significantly lower abundance of Escherichia coli and Staphylococcus in the intestine at 72 hours after treatment (P<0.05).
CONCLUSIONS


In neonates with hyperbilirubinemia, phototherapy combined with Saccharomyces boulardii can effectively reduce bilirubin level and prevent the recurrence of jaundice. Saccharomyces boulardii can favour the treatment outcome by regulating the gut microbiota of neonates.",2020,"Compared with the control group, the observation group had a significantly higher abundance of Bacteroides (P<0.05) and a significantly lower abundance of Escherichia coli and Staphylococcus in the intestine at 72 hours after treatment (P<0.05).
","['neonates with hyperbilirubinemia, phototherapy combined with', 'hyperbilirubinemia in neonates', 'neonates with hyperbilirubinemia who were hospitalized from January to December 2018']","['phototherapy combined with placebo', 'phototherapy combined with Saccharomyces boulardii', 'Saccharomyces boulardii combined with phototherapy', 'Saccharomyces boulardii']","['recurrence of jaundice', 'level of total serum bilirubin', 'total serum bilirubin level', 'proportion of neonates requiring phototherapy', 'abundance of Bacteroides', 'bilirubin level', 'abundance of Escherichia coli and Staphylococcus']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}]",,0.0397521,"Compared with the control group, the observation group had a significantly higher abundance of Bacteroides (P<0.05) and a significantly lower abundance of Escherichia coli and Staphylococcus in the intestine at 72 hours after treatment (P<0.05).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu 212000, China. zjtangwei@163.com.'}, {'ForeName': 'Hong-Yan', 'Initials': 'HY', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Xu', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
1641,33172627,People considering exercise to prevent low back pain recurrence prefer exercise programs that differ from programs known to be effective: a discrete choice experiment.,"QUESTION


Do program and participant characteristics influence people's willingness to undertake exercise programs to prevent recurrence of low back pain?
DESIGN


Discrete choice experiment.
PARTICIPANTS


Six hundred and forty-seven people with a recent history of low back pain.
DATA COLLECTION


Recruitment and participation occurred online. Participants were randomised to a block of 10 choice tasks, where the characteristics of the exercise program varied systematically. The characteristics that were presented for each exercise program were mode of exercise delivery, mode of supervision, setting, duration, weekly frequency, travel time, risk of recurrence, and costs. For each choice task, participants chose between no program or an exercise program with the characteristics as presented.
DATA ANALYSIS


Choices were analysed using mixed logit models. Latent class models examined preference heterogeneity and identified participant-level characteristics predictive of preferences.
RESULTS


There appeared to be an underlying preference for exercise compared with no exercise, all else being equal. Preferences for programs were significantly influenced by the characteristics of the programs. Participants were less likely to choose exercise when programs were of a longer duration (OR 0.92, 95% CI 0.89 to 0.96 per extra month), but more likely to prefer programs offering greater reduction in the risk of recurrence of low back pain (OR 3.91, 95% CI 3.20 to 4.79 per 10% reduction in risk of recurrence). Preferences for engaging in exercise programs to prevent recurrent of low back pain were influenced by the characteristics of the programs themselves. However, there was mismatch between the preferred characteristics of exercise programs and the characteristics of known effective programs.
CONCLUSION


People who have had low back pain should be advised explicitly about which exercise programs reduce recurrence. Understanding low back pain patients' preferences can help inform the implementation of existing prevention programs and guide the design of new prevention programs.",2020,"Participants were less likely to choose exercise when programs were of a longer duration (OR 0.92, 95% CI 0.89 to 0.96 per extra month), but more likely to prefer programs offering greater reduction in the risk of recurrence of low back pain (OR 3.91, 95% CI 3.20 to 4.79 per 10% reduction in risk of recurrence).","['Six hundred and forty-seven people with a recent history of low back pain', 'People who have had low back pain']",[],"['risk of recurrence of low back pain', 'recurrent of low back pain']","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",647.0,0.0839833,"Participants were less likely to choose exercise when programs were of a longer duration (OR 0.92, 95% CI 0.89 to 0.96 per extra month), but more likely to prefer programs offering greater reduction in the risk of recurrence of low back pain (OR 3.91, 95% CI 3.20 to 4.79 per 10% reduction in risk of recurrence).","[{'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia; School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Electronic address: giovanni.ferreira@sydney.edu.au.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia; School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Zadro', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia; School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Electronic address: https://twitter.com/zadro_josh.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia; School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Electronic address: https://twitter.com/MaryOKeefe007.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia; School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Electronic address: https://twitter.com/DrChristineLin.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, Australia; School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Electronic address: https://twitter.com/CGMMaher.'}]",Journal of physiotherapy,['10.1016/j.jphys.2020.09.011']
1642,33172881,"Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial.","BACKGROUND


Immune checkpoint inhibitors monotherapy has been studied in patients with advanced biliary tract cancer (BTC). The aim of this study was to assess the efficacy and safety of camrelizumab, plus gemcitabine and oxaliplatin (GEMOX) as first-line treatment in advanced BTC and explored the potential biomarkers associated with response.
METHODS


In this single-arm, open-label, phase II study, we enrolled stage IV BTC patients. Participants received camrelizumab (3 mg/kg) plus gemcitabine (800 mg/m 2 ) and oxaliplatin (85 mg/m 2 ). Primary endpoints were 6-month progression-free survival (PFS) rate and safety. Secondary endpoints were objective response rate (ORR), PFS and overall survival (OS). Exploratory endpoints included association between response and tumor mutational burden (TMB), blood TMB, dynamic change of ctDNA and immune microenvironment.
RESULTS


54 patients with advanced BTC were screened, of whom 38 eligible patients were enrolled. One patient withdrew informed consent before first dose treatment. Median follow-up was 11.8 months. The 6-month PFS rate was 50% (95% CI 33 to 65). Twenty (54%) out of 37 patients had an objective response. The median PFS was 6.1 months and median OS was 11.8 months. The most common treatment-related adverse events (TRAEs) were fatigue (27 (73%)) and fever (27 (73%)). The most frequent grade 3 or worse TRAEs were hypokalemia (7 (19%)) and fatigue (6 (16%)). The ORR was 80% in patients with programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) ≥1% versus 53.8% in PD-L1 TPS <1%. There was no association between response and TMB, blood TMB, immune proportion score or immune cells (p>0.05), except that PFS was associated with blood TMB. Patients with positive post-treatment ctDNA had shorter PFS (p=0.007; HR, 2.83; 95% CI 1.27 to 6.28).
CONCLUSION


Camrelizumab plus GEMOX showed a promising antitumor activity and acceptable safety profile as first-line treatment in advanced BTC patients. Potential biomarkers are needed to identify patients who might respond to camrelizumab plus GEMOX.
TRIAL REGISTRATION NUMBER


NCT03486678.",2020,"Patients with positive post-treatment ctDNA had shorter PFS (p=0.007; HR, 2.83; 95% CI 1.27 to 6.28).
","['patients with advanced biliary tract cancer (BTC', '54 patients with advanced BTC were screened, of whom 38 eligible patients were enrolled', 'patients who might respond to camrelizumab plus GEMOX', 'patients with advanced biliary tract cancer', 'advanced BTC patients']","['camrelizumab', 'oxaliplatin', 'gemcitabine', 'Camrelizumab plus gemcitabine and oxaliplatin (GEMOX', 'camrelizumab, plus gemcitabine and oxaliplatin (GEMOX', 'Camrelizumab plus GEMOX']","['6-month PFS rate', 'proportion score (TPS', 'antitumor activity and acceptable safety profile', 'shorter PFS', 'efficacy and safety', 'ORR', '6-month progression-free survival (PFS) rate and safety', 'response and tumor mutational burden (TMB), blood TMB, dynamic change of ctDNA and immune microenvironment', 'objective response', 'hypokalemia', 'fatigue', 'fever', 'response and TMB, blood TMB, immune proportion score or immune cells', 'objective response rate (ORR), PFS and overall survival (OS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",54.0,0.0949016,"Patients with positive post-treatment ctDNA had shorter PFS (p=0.007; HR, 2.83; 95% CI 1.27 to 6.28).
","[{'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Medical Department, Nanjing Geneseeq Technology Inc, Nanjing, China.'}, {'ForeName': 'Qianwen', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feipeng', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Nanjing Red Cross Hospital, Nanjing, China.'}, {'ForeName': 'Fengjiao', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Department of Oncology, Jiangyin People's Hospital, Jiangyin, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Gaohua', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': ""Department of Oncology, Taizhou People's Hospital Affiliated to Nantong University, Taizhou, China.""}, {'ForeName': 'Changxian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Poshita Kumari', 'Initials': 'PK', 'LastName': 'Seesaha', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dongqin', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Medical Department, Nanjing Geneseeq Technology Inc, Nanjing, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Medical Department, Jiangsu Hengrui Medicine Co Ltd, Lianyungang, China.'}, {'ForeName': 'Junling', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Medical Department, 3D Medicines Inc, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Medical Department, Burning Rock Biotech, Guangzhou, China.'}, {'ForeName': 'Xuehao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangcheng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hepatobiliary Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China shuyongqian@csco.org.cn.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-001240']
1643,33151888,The Impact of Nonminimum-Phase Zeros on Human-in-the-Loop Control Systems.,"We present results from an experiment in which 33 human subjects interact with a dynamic system 40 times over a one-week period. The subjects are divided into three groups. For each interaction, a subject performs a command-following task, where the reference command is the same for all trials and all subjects. However, each group interacts with a different dynamic system, which is represented by a transfer function. The transfer functions have the same poles but different zeros. One has a minimum-phase zero zₘ < 0, another has a nonminimum-phase zero zₙ = - zₘ > 0, and the last has a slower (i.e., closer to the imaginary axis) nonminimum-phase zero zsn ∈ (0,zₙ). The experimental results show that nonminimum-phase zeros tend to make dynamic systems more difficult for humans to learn to control. We use a subsystem identification algorithm to identify the control strategy that each subject uses on each trial. The identification results show that the identified feedforward controllers approximate the inverse dynamics of the system with which the subjects interact better on the last trial than on the first trial. However, the subjects interacting with the minimum-phase system are able to approximate the inverse dynamics in feedforward more accurately than the subjects interacting with the nonminimum-phase system. This observation suggests that nonminimum-phase zeros are an impediment to approximating inverse dynamics in feedforward. Finally, we provide evidence that humans rely on feedforward-step-like-control strategies with systems (e.g., nonminimum-phase systems) for which it is difficult to approximate the inverse dynamics in feedforward.",2020,The identification results show that the identified feedforward controllers approximate the inverse dynamics of the system with which the subjects interact better on the last trial than on the first trial.,['33 human subjects interact with a dynamic system 40 times over a one-week period'],[],[],"[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1442452', 'cui_str': 'One week'}]",[],[],33.0,0.0103914,The identification results show that the identified feedforward controllers approximate the inverse dynamics of the system with which the subjects interact better on the last trial than on the first trial.,"[{'ForeName': 'Xingye', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': 'Seigler', 'Affiliation': ''}, {'ForeName': 'Jesse B', 'Initials': 'JB', 'LastName': 'Hoagg', 'Affiliation': ''}]",IEEE transactions on cybernetics,['10.1109/TCYB.2020.3027502']
1644,33151934,Evaluation of an intervention to provide brief support and personalized feedback on food shopping to reduce saturated fat intake (PC-SHOP): A randomized controlled trial.,"BACKGROUND


Guidelines recommend reducing saturated fat (SFA) intake to decrease cardiovascular disease (CVD) risk, but there is limited evidence on scalable and effective approaches to change dietary intake, given the large proportion of the population exceeding SFA recommendations. We aimed to develop a system to provide monthly personalized feedback and healthier swaps based on nutritional analysis of loyalty card data from the largest United Kingdom grocery store together with brief advice and support from a healthcare professional (HCP) in the primary care practice. Following a hybrid effectiveness-feasibility design, we tested the effects of the intervention on SFA intake and low-density lipoprotein (LDL) cholesterol as well as the feasibility and acceptability of providing nutritional advice using loyalty card data.
METHODS AND FINDINGS


The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study is a parallel randomized controlled trial with a 3 month follow-up conducted between 21 March 2018 to 16 January2019. Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to ""Brief Support"" (BS, n = 48), ""Brief Support + Shopping Feedback"" (SF, n = 48) or ""Control"" (n = 17). BS consisted of a 10-minute consultation with an HCP to motivate participants to reduce their SFA intake. Shopping feedback comprised a personalized report on the SFA content of grocery purchases and suggestions for lower SFA swaps. The primary outcome was the between-group difference in change in SFA intake (% total energy intake) at 3 months adjusted for baseline SFA and GP practice using intention-to-treat analysis. Secondary outcomes included %SFA in purchases, LDL cholesterol, and feasibility outcomes. The trial was powered to detect an absolute reduction in SFA of 3% (SD3). Neither participants nor the study team were blinded to group allocation. A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index (BMI) 27.1 kg/m2 (SD 4.7). There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901). There were similar trends in %SFA based on supermarket purchases: control = -0.5% (95% CI -2.3 to 1.2), BS = -1.3% (95% CI -2.3 to -0.3), SF = -1.5% (95% CI -2.5 to -0.5) from baseline to follow-up, but these were not significantly different: BS versus control p = 0.379; SF versus control p = 0.411. There were small reductions in LDL from baseline to follow-up (control = -0.14 mmol/L [95% CI -0.48, 0.19), BS: -0.39 mmol/L [95% CI -0.59, -0.19], SF: -0.14 mmol/L [95% CI -0.34, 0.07]), but these were not significantly different: BS versus control p = 0.338; SF versus control p = 0.790. Limitations of this study include the small sample of participants recruited, which limits the power to detect smaller differences, and the low response rate (3%), which may limit the generalisability of these findings.
CONCLUSIONS


In this study, we have shown it is feasible to deliver brief advice in primary care to encourage reductions in SFA intake and to provide personalized advice to encourage healthier choices using supermarket loyalty card data. There was no evidence of large reductions in SFA, but we are unable to exclude more modest benefits. The feasibility, acceptability, and scalability of these interventions suggest they have potential to encourage small changes in diet, which could be beneficial at the population level.
TRIAL REGISTRATION


ISRCTN14279335.",2020,"There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901).","['Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to', 'A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index']","['Brief Support"" (BS, n = 48), ""Brief Support + Shopping Feedback"" (SF, n = 48) or ""Control']","['SFA intake', 'saturated fat intake (PC-SHOP', 'LDL', 'SFA in purchases, LDL cholesterol, and feasibility outcomes', 'SFA intake and low-density lipoprotein (LDL) cholesterol', 'change in SFA intake']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0454871', 'cui_str': 'Oxfordshire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0556120', 'cui_str': 'Saturated fat intake'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",113.0,0.386053,"There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Tsiountsioura', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Noreik', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Oke', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Madigan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",PLoS medicine,['10.1371/journal.pmed.1003385']
1645,33151955,Comprehensive treatment of microvascular angina in overweight women - a randomized controlled pilot trial.,"AIMS


Coronary microvascular dysfunction (CMD) carries a poor cardiovascular prognosis and may explain angina in women without obstructive coronary artery disease (CAD). Currently, no evidence-based treatment for CMD exists. We investigated whether reducing cardiovascular risk factors improves symptoms and microvascular function in women with non-endothelial dependent CMD and no obstructive CAD.
METHODS


We randomized 62 women aged 40-75, with body mass index (BMI) >25 kg/m2, angina ≥monthly, and coronary flow velocity reserve (CFVR) ≤2.5 to a 24-week intervention comprising low energy diet, exercise training, and optimized treatment of hypertension, dyslipidemia and diabetes or to control. Patients were assessed before randomization and after 24 weeks. Primary outcomes were CFVR assessed by transthoracic Doppler stress-echocardiography and angina burden by Seattle Angina Questionnaire (SAQ). Secondary outcomes were exercise capacity, body composition, glycemic control, myocardial function, and anxiety and depression symptoms.
RESULTS


Fifty-six participants (90%) completed the study. Median (IQR) age was 65.2 (57.1;70.7) years, BMI was 30.1 (28.4;32.7) kg/m2. The intervention resulted in relevant improvement in angina symptoms (9-21-point increase on SAQ-scales (all p<0.01)) but had no effect on CFVR (p = 0.468). Mean (CI) weight loss was 9.6 (7.80;11.48) kg, (p<0.0001). There was a significant mean (CI) decrease in depression symptoms = 1.16 (0.22;2.12), triglycerides = 0.52 (0.25;0.78) mmol/L, total cholesterol = 0.55 (0.12;0.98) mmol/L, and HbA1c in diabetics = 27.1 (1.60;52.6) mmol/mol but no effect on other secondary outcomes.
CONCLUSION


A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.",2020,A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.,"['women with non-endothelial dependent CMD and no obstructive CAD', 'Fifty-six participants (90%) completed the study', 'women with microvascular angina', 'women without obstructive coronary artery disease (CAD', '62 women aged 40-75, with body mass index (BMI) >25 kg/m2, angina ≥monthly, and coronary flow velocity reserve (CFVR) ≤2.5 to a 24-week intervention comprising', 'microvascular angina in overweight women ']","['low energy diet, exercise training']","['mean (CI) decrease in depression symptoms', 'angina symptoms', 'Median (IQR) age', 'CFVR assessed by transthoracic Doppler stress-echocardiography and angina burden by Seattle Angina Questionnaire (SAQ', 'exercise capacity, body composition, glycemic control, myocardial function, and anxiety and depression symptoms', 'CFVR', 'coronary microvascular function', 'SAQ-scales', 'angina burden', 'Mean (CI) weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C3696962', 'cui_str': 'Coronary microvascular dysfunction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",62.0,0.196239,A major weight loss and intensified risk factor control resulted in significantly improved angina burden but no improvement of coronary microvascular function among women with microvascular angina.,"[{'ForeName': 'Kira Bang', 'Initials': 'KB', 'LastName': 'Bove', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Endocrinology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene Rørholm', 'Initials': 'LR', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mikkelsen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hannah Elena', 'Initials': 'HE', 'LastName': 'Suhrs', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prescott', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0240722']
1646,33153145,Wearing of Cloth or Disposable Surgical Face Masks has no Effect on Vigorous Exercise Performance in Healthy Individuals.,"Wearing face masks is recommended for the prevention of contracting or exposing others to cardiorespiratory infections, such as COVID-19. Controversy exists on whether wearing face masks during vigorous exercise affects performance. We used a randomized, counterbalanced cross-over design to evaluate the effects of wearing a surgical mask, a cloth mask, or no mask in 14 participants (7 men and 7 women; 28.2 ± 8.7 y) during a cycle ergometry test to exhaustion. Arterial oxygen saturation (pulse oximetry) and tissue oxygenation index (indicator of hemoglobin saturation/desaturation) at vastus lateralis (near-infrared spectroscopy) were assessed throughout the exercise tests. Wearing face masks had no effect on performance (time to exhaustion (mean ± SD): no mask 622 ± 141 s, surgical mask 657 ± 158 s, cloth mask 637 ± 153 s ( p  = 0.20); peak power: no mask 234 ± 56 W, surgical mask 241 ± 57 W, cloth mask 241 ± 51 W ( p  = 0.49)). When expressed relative to peak exercise performance, no differences were evident between wearing or not wearing a mask for arterial oxygen saturation, tissue oxygenation index, rating of perceived exertion, or heart rate at any time during the exercise tests. Wearing a face mask during vigorous exercise had no discernable detrimental effect on blood or muscle oxygenation, and exercise performance in young, healthy participants (ClinicalTrials.gov, NCT04557605).",2020,"Wearing a face mask during vigorous exercise had no discernable detrimental effect on blood or muscle oxygenation, and exercise performance in young, healthy participants (ClinicalTrials.gov, NCT04557605).","['14 participants (7 men and 7 women; 28.2 ± 8.7 y) during a cycle ergometry test to exhaustion', 'young, healthy participants (ClinicalTrials.gov, NCT04557605', 'Healthy Individuals']","['wearing a surgical mask, a cloth mask, or no mask']","['blood or muscle oxygenation, and exercise performance', 'wearing or not wearing a mask for arterial oxygen saturation, tissue oxygenation index, rating of perceived exertion, or heart rate', 'Vigorous Exercise Performance', 'peak exercise performance', 'Arterial oxygen saturation (pulse oximetry) and tissue oxygenation index (indicator of hemoglobin saturation/desaturation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}]",,0.0295021,"Wearing a face mask during vigorous exercise had no discernable detrimental effect on blood or muscle oxygenation, and exercise performance in young, healthy participants (ClinicalTrials.gov, NCT04557605).","[{'ForeName': 'Keely', 'Initials': 'K', 'LastName': 'Shaw', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Scotty', 'Initials': 'S', 'LastName': 'Butcher', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Saskatoon, SK S7N 2Z4, Canada.'}, {'ForeName': 'Jongbum', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, SK S7N 5B2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17218110']
1647,33153295,"Response by Zhao et al to Letter Regarding Article, ""Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial"".",,2020,,['Atrial Septal Defect Closure'],[],[],"[{'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}]",[],[],,0.0408773,,"[{'ForeName': 'Guangzhi', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Pengxu', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiangbin', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.010130']
1648,33153296,"Letter by Ovaert et al Regarding Article, ""Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial"".",,2020,,['Atrial Septal Defect Closure'],[],[],"[{'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}]",[],[],,0.0582011,,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ovaert', 'Affiliation': 'Paediatric and Congenital Cardiology, Timone, AP-HM, Aix-Marseille University, Marseille, France (C.O.).'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bonnet', 'Affiliation': 'Paediatric and Congenital Cardiology, Hopital Necker-Enfants malades, AP-HP, Université de Paris, France (D.B., S.M.-M.).'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Malekzadeh-Milani', 'Affiliation': 'Paediatric and Congenital Cardiology, Hopital Necker-Enfants malades, AP-HP, Université de Paris, France (D.B., S.M.-M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.010121']
1649,33154508,"Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial.","In addition to smoking cessation, for those who would otherwise continue to smoke, replacing cigarettes with less harmful alternatives can reduce the harms of smoking. Heating instead of burning tobacco reduces, or eliminates, the formation of harmful and potentially harmful constituents (HPHC) that are found in cigarette smoke. The Carbon-Heated Tobacco Product (CHTP), a heat-not-burn tobacco product, mimics the cigarette smoking ritual. This randomized, open-label, two-arm, parallel-group, short-term confinement study tested the hypothesis that the geometric means of the BoExp levels for subjects switching to CHTP 1.0 for 5 days are lower relative to those continuing to smoke cigarettes. Biomarkers of exposure (BoExp), including nicotine, urinary excretion of mutagenic constituents (Ames test), and cytochrome P450 (CYP) 1A2 activity, were measured in blood and/or 24-h urine samples during ad libitum product use. Nicotine exposure remained at similar levels in individuals using CHTP as in those continuing to smoke cigarettes. Switching to CHTP resulted in marked decreases in all other urinary BoExp (56-97%), carboxyhemoglobin (59%), urinary mutagenic constituents, and CYP1A2 activity compared with continued cigarette smoking. Our results provide evidence of decreased exposure to 15 selected HPHCs in smokers switching from cigarettes to exclusive CHTP use.Trial registration ClinicalTrials.gov: NCT02503254; Date of first registration: 20/07/2015 https://www.clinicaltrials.gov/ct2/show/NCT02503254 .Study protocol Study protocol published at: https://www.clinicaltrials.gov/ProvidedDocs/54/NCT02503254/Prot_000.pdf .",2020,"Switching to CHTP resulted in marked decreases in all other urinary BoExp (56-97%), carboxyhemoglobin (59%), urinary mutagenic constituents, and CYP1A2 activity compared with continued cigarette smoking.",[],"['CHTP', 'Carbon-Heated Tobacco Product (CHTP', 'Nicotine']","['nicotine, urinary excretion of mutagenic constituents (Ames test), and cytochrome P450 (CYP) 1A2 activity', 'formation of harmful and potentially harmful constituents (HPHC', 'urinary BoExp', 'urinary mutagenic constituents, and CYP1A2 activity']",[],"[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}]",,0.0309428,"Switching to CHTP resulted in marked decreases in all other urinary BoExp (56-97%), carboxyhemoglobin (59%), urinary mutagenic constituents, and CYP1A2 activity compared with continued cigarette smoking.","[{'ForeName': 'Cam Tuan', 'Initials': 'CT', 'LastName': 'Tran', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland. CamTuan.Tran@pmi.com.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'de La Bourdonnaye', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Blanc', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'PMI Science & Innovation, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000, Neuchâtel, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-76222-y']
1650,33155295,Impact of exercise training and supplemental oxygen on submaximal exercise performance in patients with COPD.,"Functional impairment caused by chronic obstructive pulmonary disease (COPD) impacts on activities of daily living and quality of life. Indeed, patients' submaximal exercise capacity is of crucial importance. It was the aim of this study to investigate the effects of an exercise training intervention with and without supplemental oxygen on submaximal exercise performance. This is a secondary analysis of a randomized, controlled, double-blind, crossover trial. 29 COPD patients (63.5 ± 5.9 years; FEV 1  46.4 ± 8.6%) completed two consecutive 6-week periods of high-intensity interval cycling and strength training, which was performed three times/week with either supplemental oxygen or medical air (10 L/min). Submaximal exercise capacity as well as the cardiocirculatory, ventilatory, and metabolic response were evaluated at isotime (point of termination in the shortest cardiopulmonary exercise test), at physical work capacity at 110 bpm of heart rate (PWC 110), at the anaerobic threshold (AT), and at the lactate-2 mmol/L threshold. After 12 weeks of exercise training, patients improved in exercise tolerance, shown by decreased cardiocirculatory (heart rate, blood pressure) and metabolic (respiratory exchange ratio, lactate) effort at isotime; ventilatory response was not affected. Submaximal exercise capacity was improved at PWC 110, AT and the lactate-2 mmol/L threshold, respectively. Although supplemental oxygen seems to affect patients' work rate at AT and the lactate-2 mmol/L threshold, no other significant effects were found. The improved submaximal exercise capacity and tolerance might counteract patients' functional impairment. Although cardiovascular and metabolic training adaptations were shown, ventilatory efficiency remained essentially unchanged. The impact of supplemental oxygen seems less important on submaximal training effects.",2020,"Submaximal exercise capacity was improved at PWC 110, AT and the lactate-2 mmol/L threshold, respectively.","['chronic obstructive pulmonary disease (COPD', 'patients with COPD', '29 COPD patients (63.5±5.9 years; FEV 1  46.4±8.6%) completed two consecutive 6-week periods of']","['supplemental oxygen or medical air', 'exercise training', 'exercise training intervention', 'exercise training and supplemental oxygen', 'high intensity interval cycling and strength training']","['cardiocirculatory (heart rate, blood pressure) and metabolic (respiratory exchange ratio, lactate) effort at isotime; ventilatory response', 'activities of daily living and quality of life', 'cardiocirculatory, ventilatory and metabolic response', 'submaximal exercise performance', 'submaximal exercise capacity and tolerance', 'Submaximal exercise capacity', 'ventilatory efficiency']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",29.0,0.0565953,"Submaximal exercise capacity was improved at PWC 110, AT and the lactate-2 mmol/L threshold, respectively.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Neunhäuserer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mayr', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kaiser', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lamprecht', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ermolao', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Studnicka', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University Salzburg, Salzburg, Austria.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13870']
1651,33155849,The burden of musculoskeletal pain and the role of topical non-steroidal anti-inflammatory drugs (NSAIDs) in its treatment. Ten underpinning statements from a global pain faculty.,"This document presents the conclusions of a detailed discussion on the role of topical NSAIDs during a round table Global Pain Faculty meeting held in Amsterdam in 2019 and subsequent discussions online. The aim of this evidence-based document is to describe the impact of musculoskeletal pain both in terms of the large numbers of sufferers and its economic impact. The document considers the place of topical therapies alongside other pharmacological and non-pharmacological treatments and presents the evidence for the benefits and harms of topical NSAIDS including indicators of efficacy for three main topical NSAIDs- diclofenac, ibuprofen and ketoprofen - based on almost 15,000 participants in randomized controlled trials for acute and chronic musculoskeletal pain. These topical NSAIDs have the largest body of evidence. For acute pain, numbers needed to treat to achieve at least 50% reduction in pain are as follows with 95% confidence intervals in brackets: Diclofenac emulgel 1.8(1.5-2.1) (5170 participants), Ibuprofen gel 2.7 (1.7-4.2) (436 participants), Ketoprofen gel 2.2 (1.7-2.8) (683 participants). For chronic pain, the NNTs are Diclofenac any formulation 9.5(7-14) (5995 participants). Ketoprofen 6.9(5.5-9.3) (2573 participants). Randomized controlled trial evidence suggests that adverse events for active topical NSAIDs are similar to placebo. Finally the gaps in knowledge are considered with suggestions on how further research might help. The global pain faculty was brought together by GSK under an unrestricted educational grant.",2020,"For chronic pain, the NNTs are Diclofenac any formulation 9.5(7-14) (5995 participants).","['15,000 participants in randomised controlled trials for acute and chronic musculoskeletal pain']","['diclofenac, ibuprofen and ketoprofen', 'Ibuprofen gel', 'placebo', 'Ketoprofen', 'Ketoprofen gel']","['burden of musculoskeletal pain', 'pain']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.361133,"For chronic pain, the NNTs are Diclofenac any formulation 9.5(7-14) (5995 participants).","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'McMahon', 'Affiliation': ""Wellcome Trust Pain Consortium, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dargan', 'Affiliation': ""Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK.""}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lanas', 'Affiliation': 'University Clinic Hospital, University of Zaragoza, CIBERehd, IIS Aragón, Zaragoza, Spain.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wiffen', 'Affiliation': 'Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.'}]",Current medical research and opinion,['10.1080/03007995.2020.1847718']
1652,32778491,Editor's Choice - Relationship Between Global Limb Anatomic Staging System (GLASS) and Clinical Outcomes Following Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial.,"OBJECTIVE


The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied.
METHODS


Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004).
RESULTS


There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p = .049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01-1.85; p = .042), LS (HR 1.96; 95 % CI 1.12-3.43; p = .018), and FF-MALE (HR 1.49; 95% CI 1.04-1.87; p = .028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p < .001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts.
CONCLUSION


In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials.",2020,FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001).,"['377 patients undergoing endovascular therapy (EVT, n\xa0=\xa0213) or bypass surgery (BS, n\xa0=\xa0164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999-2004', 'chronic limb threatening ischaemia (CLTI', 'Chronic Limb Threatening Ischaemia in the Bypass Versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 Trial']","['Global Limb Anatomic Staging System (GLASS', 'GLASS']","['ITF and GLASS in EVT', 'GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE', 'FF-MALE', 'GLASS FP grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449394', 'cui_str': 'Staging system'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0949591', 'cui_str': 'Limb Salvage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",377.0,0.223117,FF-MALE was significantly worse after EVT than BS in GLASS II (p = .038) and III (p = .001).,"[{'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Kodama', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, Japan. Electronic address: akodama@med.nagoya-u.ac.jp.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Meecham', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Popplewell', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Bate', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, University of California at San Francisco, CA, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Bradbury', 'Affiliation': 'Department of Vascular Surgery, University of Birmingham, UK.'}]",European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery,['10.1016/j.ejvs.2020.06.042']
1653,33157357,Effects of modified version of the Hospital Elder Life Program on post-discharge cognitive function and activities of daily living among older adults undergoing total knee arthroplasty.,"OBJECTIVES


This study aimed to investigate the effects of a modified Hospital Elder Life Program (mHELP) on post-discharge cognition and physical function among older adults undergoing total knee arthroplasty (TKA), and to evaluate the incidence of postoperative delirium.
DESIGN


Non-randomized intervention trial.
SETTING AND PARTICIPANTS


A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included.
METHODS


Ward-level stratification was used with one surgical ward receiving mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group). All participants were assigned to two surgical wards. Outcome measures were collected using MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments at 1, 6, and 12 months after discharge. Multiple linear regression analysis was used to measure effects of mHELP intervention on mean differences in tMMSE, ADL and IADL scores from baseline to 1-, 6- and 12-months.
RESULTS


Effects of mHELP intervention significantly preserved cognitive function at 1 and 12 months, but not at 6 months, compared with controls, regardless of adjustments for confounders. However, no intervention effects were noted in ADL and IADL scores. Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
CONCLUSIONS


mHELP intervention preserves post-discharge cognitive function, but has no notable effect on ADL and IADL function in older adults undergoing elective TKA surgery.",2020,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","['older adults undergoing total knee arthroplasty', 'older adults undergoing elective TKA surgery', 'A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included', 'older adults undergoing total knee arthroplasty (TKA']","['modified version of the Hospital Elder Life Program', 'mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group', 'mHELP intervention', 'modified Hospital Elder Life Program (mHELP']","['MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments', 'tMMSE, ADL and IADL scores', 'ADL and IADL scores', 'cognitive function', 'Postoperative delirium']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",140.0,0.0811517,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","[{'ForeName': 'Chih-Kuang', 'Initials': 'CK', 'LastName': 'Liang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Che-Sheng', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Ying-Hsin', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Chou', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Yu-Te', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jenn-Huei', 'Initials': 'JH', 'LastName': 'Renn', 'Affiliation': 'Department of Orthopaedics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Medical Affair Administration, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yun', 'Initials': 'TY', 'LastName': 'Liu', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Chang', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Division of Clinical Toxicology & Occupational Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. Electronic address: ccyang@vghtpe.gov.tw.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104284']
1654,33157378,The effects of the Australian bushfires on physical activity in children.,"OBJECTIVES


To determine the impact of bushfires on children's physical activity.
DESIGN


Natural experiment comparing device-measured physical activity and air quality index data for schools exposed and not exposed to the Australian bushfires.
METHODS


Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a school-based physical activity intervention that coincided with the 2019 Australian bushfires. Students in Years 3 and 4 (8-10 years old) provided data. We used propensity score matching to match 245 exposed and 344 control participants.
MAIN OUTCOME MEASURES


Minutes of moderate and vigorous physical activity.
RESULTS


The bushfires had minimal effect on children's average weekly physical activity. Analysis of acute effects showed children maintained their levels of physical activity up to an estimated turning point of air quality index of 737.08 (95% CI = 638.63, 835.53), beyond which daily physical activity levels dropped sharply. Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
CONCLUSIONS


Children's physical activity was not strongly influenced by the presence of smoke and targeted public health advice during the bushfires might not have had the intended effect of reducing children's outdoor physical activity. Only when air quality deteriorated to approximately 3.5 times the Air Quality index threshold (>200) deemed 'hazardous' by the Australian Department of Health did children's physical activity decline. Public health agencies should re-evaluate the effectiveness of health messages during bushfires and develop strategies to mitigate risks to children's health.",2020,"Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
","['344 control participants', 'schools exposed and not exposed to the Australian bushfires', 'Students in Years 3 and 4 (8-10\xa0years old) provided data', 'children', 'Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a']",['school-based physical activity intervention'],"['Minutes of moderate and vigorous physical activity', 'daily physical activity levels', 'physical activity and air quality index data', 'physical activity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0469317,"Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Del Pozo Cruz', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia. Electronic address: Borja.delPozoCruz@acu.edu.au.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hartwig', 'Affiliation': 'Faculty of Health Sciences, School of Behavioural and Health Sciences, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Taren', 'Initials': 'T', 'LastName': 'Sanders', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noetel', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia; School of Behavioural and Health Sciences, Australian Catholic University, Queensland, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Parker', 'Affiliation': 'Positive Psychology Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Antczak', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, Faculty of Education and Arts, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'Behaviour, Environment and Cognition Research Program, Mary Mackillop Institute for Health Research, Faculty of Health Sciences, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}]",Environment international,['10.1016/j.envint.2020.106214']
1655,33157398,Muscles and bare chests on Instagram: The effect of Influencers' fashion and fitspiration images on men's body image.,"Despite men using social media in increasing numbers, as yet there has been little research addressing effects on men's body image. The aim of the present study was to investigate the effect of exposure to idealized male Instagram images on men's body satisfaction. Participants were 300 men aged 18-30 years who were randomly assigned to view clothed (fashion) images, bare-chested (fitspiration) images, or control images of scenery, posted by the same male Instagram Influencers. It was found that exposure to bare-chested and muscular images resulted in significantly lower body satisfaction relative to viewing clothed fashion images or scenery images, which did not differ from each other. The clothed and bare-chested conditions did not differ in amount of appearance-based social comparison, nor in reported inspiration to exercise or eat healthily. Nor was there any moderation of effects by muscular-ideal internalization. It was concluded that although they are vulnerable to some types of social media imagery, results typically obtained for women cannot simply be generalized to men.",2020,"It was found that exposure to bare-chested and muscular images resulted in significantly lower body satisfaction relative to viewing clothed fashion images or scenery images, which did not differ from each other.","[""men's body image"", ""men's body satisfaction"", 'Participants were 300 men aged 18-30 years']","['view clothed (fashion) images, bare-chested (fitspiration) images, or control images of scenery, posted by the same male Instagram Influencers']",['Muscles and bare chests on Instagram'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",300.0,0.0183932,"It was found that exposure to bare-chested and muscular images resulted in significantly lower body satisfaction relative to viewing clothed fashion images or scenery images, which did not differ from each other.","[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, Australia. Electronic address: Marika.Tiggemann@flinders.edu.au.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Anderberg', 'Affiliation': 'School of Psychology, Flinders University, Australia.'}]",Body image,['10.1016/j.bodyim.2020.10.001']
1656,33157425,"Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial.","BACKGROUND


The aim of this study was to determine the efficacy of exogenous melatonin supplementation for sleep disturbances in patients with middle-aged primary insomnia.
METHODS


This is a randomized double-blind, placebo-controlled parallel study. Participants were recruited from Tianlin community, Xuhui district, Shanghai. Ninety-seven consecutive middle-aged patients with primary insomnia were randomized to receive 3 mg fast-release melatonin (n = 51) or placebo (n = 46) for four-weeks. Objective sleep parameters tested by overnight polysomnography, subjective sleep performance and daytime somnolence obtained from the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS) were obtained at baseline and after treatment. Treatment was taken daily 1 h before bedtime. Serious adverse events and side-effects were monitored.
RESULTS


Melatonin supplementation significantly decreased early wake time [-30.63min (95% CI, -53.92 to -7.34); P = 0.001] and percentage of N2 sleep [-7.07% (95% CI, -13.47% to -0.68%); P = 0.031]. However, melatonin had no significant effect on other objective sleep parameters including sleep latency, sleep efficiency, wake during the sleep and percent of N1, N3 and REM sleep. Melatonin had no effect on insomnia symptoms and severity on the PSQI [1.53(95% CI, -0.55 to 3.61); p = 0.504]; ISI [0.81 (95% CI, -2.27 to 3.88); p = 0.165] and ESS [-0.83 (95% CI, -3.53 to 1.88); p = 0.147]. No serious adverse events were reported.
CONCLUSIONS


Melatonin supplementation over a four-week period is effective and safe in improving some aspects of objective sleep quality such as total sleep time, percentage of rapid eye movement and early morning wake time in middle-aged patients with insomnia.
TRIAL REGISTRATION


Identifier: ChiCTR-TRC-13003997; Prospectively registered on 2 December 2013.",2020,"RESULTS


Melatonin supplementation significantly decreased early wake time [-30.63min (95% CI, -53.92 to -7.34); P = 0.001] and percentage of N2 sleep [-7.07% (95% CI, -13.47% to -0.68%);","['Ninety-seven consecutive middle-aged patients with primary insomnia', 'patients with middle-aged primary insomnia', 'middle-aged patients with insomnia', 'middle-aged primary insomnia', 'Participants were recruited from Tianlin community, Xuhui district, Shanghai']","['melatonin', 'exogenous melatonin supplementation', 'Melatonin supplementation', 'placebo', 'Melatonin', '3\xa0mg fast-release melatonin']","['insomnia symptoms and severity on the PSQI', 'Serious adverse events and side-effects', 'objective sleep parameters including sleep latency, sleep efficiency, wake during the sleep and percent of N1, N3 and REM sleep', 'sleep disturbances', 'early wake time', 'sleep disturbance', 'overnight polysomnography, subjective sleep performance and daytime somnolence obtained from the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS', 'percentage of N2 sleep', 'serious adverse events']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0541798', 'cui_str': 'Terminal insomnia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2219848', 'cui_str': 'Daytime somnolence'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C4704917', 'cui_str': 'NREM Stage 2'}]",97.0,0.518584,"RESULTS


Melatonin supplementation significantly decreased early wake time [-30.63min (95% CI, -53.92 to -7.34); P = 0.001] and percentage of N2 sleep [-7.07% (95% CI, -13.47% to -0.68%);","[{'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Chujun', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jianyin', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yupu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: zhmtiger@126.com.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Suru', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Weitian', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: drzhangwt@163.com.""}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Yi', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China. Electronic address: guanjian0606@sina.com.""}, {'ForeName': 'Zhengnong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Shankai', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery & Center of Sleep Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, 200233, Shanghai, China; Shanghai Key Laboratory of Sleep Disordered Breathing, Shanghai, China; Otolaryngological Institute of Shanghai Jiao Tong University, Shanghai, China.""}]",Sleep medicine,['10.1016/j.sleep.2020.10.018']
1657,33158822,"Association between vitamin D and uterine fibroids: a study protocol of an open-label, randomised controlled trial.","INTRODUCTION


Uterine fibroids are the most common pelvic benign tumour with no satisfactory long-term medical treatment. Recent studies have demonstrated that vitamin D significantly inhibited the growth of fibroids in vitro, vivo and a small-sample clinical trial. Therefore, the aim of this randomised clinical trial (RCT) is to evaluate whether supplementation with vitamin D could reduce the risk and inhibit the growth of uterine fibroids in reproductive stage women.
METHODS AND ANALYSIS


The open-label, RCT comprises two parts, including parts I and II. In part I, 2230 vitamin D deficiency or vitamin D insufficiency patients without uterine fibroids will be randomly assigned to two groups: intervention group (according to the level of serum 25-hydroxyvitamin D 3 , receive 1600 or 800 IU/day of vitamin D 3  for 2 years) and control group (followed up at the same time points). By using gynaecological ultrasound examinations, the incidence of uterine fibroids will be employed to measure the outcome in different groups. In part II, 360 uterine fibroids patients with vitamin D deficiency or vitamin D insufficiency will be randomly assigned to intervention group or control group. According to the level of serum 25-hydroxyvitamin D 3 , 180 patients will receive 1600 or 800 IU/day of vitamin D 3  for 2 years. Control group will receive regular follow-up. The outcome measure will be conducted using gynaecological ultrasound examinations to detect the growth of uterine fibroids in each group.
ETHICS AND DISSEMINATION


This study has been approved by the institutional review board of the Second Affiliated Hospital of Wenzhou Medical University (No. LCKY2018-35).
TRIAL REGISTRATION NUMBERS


NCT03586947 and NCT03584529.",2020,"By using gynaecological ultrasound examinations, the incidence of uterine fibroids will be employed to measure the outcome in different groups.","['360 uterine fibroids patients with vitamin D deficiency or vitamin D insufficiency', 'reproductive stage women', 'insufficiency patients without uterine fibroids']","['2230 vitamin D deficiency or vitamin D', 'intervention group (according to the level of serum 25-hydroxyvitamin D 3 , receive 1600 or 800\u2009IU/day of vitamin D 3  for 2 years) and control group', 'vitamin D', 'vitamin D and uterine fibroids']",['growth of uterine fibroids'],"[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}]",180.0,0.163327,"By using gynaecological ultrasound examinations, the incidence of uterine fibroids will be employed to measure the outcome in different groups.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sheng', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Yizuo', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Clinical Research Center, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China.'}, {'ForeName': 'Xueqiong', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Obstetrics and Gynecology, Wenzhou Medical University Second Affiliated Hospital, Wenzhou, China zjwzzxq@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-038709']
1658,33158826,"Using discrete choice experiments to design interventions for heterogeneous preferences: protocol for a pragmatic randomised controlled trial of a preference-informed, heterogeneity-focused, HIV testing offer for high-risk populations.","INTRODUCTION


Approximately one million undiagnosed persons living with HIV in Southern and Eastern Africa need to test for HIV. Novel approaches are necessary to identify HIV testing options that match the heterogeneous testing preferences of high-risk populations. This pragmatic randomised controlled trial (PRCT) will evaluate the efficacy of a preference-informed, heterogeneity-focused HIV counselling and testing (HCT) offer, for improving rates of HIV testing in two high-risk populations.
METHODS AND ANALYSIS


The study will be conducted in Moshi, Tanzania. The PRCT will randomise 600 female barworkers and 600 male Kilimanjaro mountain porters across three study arms. All participants will receive an HIV testing offer comprised of four preference-informed testing options, including one 'common' option-comprising features that are commonly available in the area and, on average, most preferred among study participants-and three options that are specific to the study arm. Options will be identified using mixed logit and latent class analyses of data from a discrete choice experiment (DCE). Participants in Arm 1 will be offered the common option and three 'targeted' options that are predicted to be more preferred than the common option and combine features widely available in the study area. Participants in Arm 2 will be offered the common option and three 'enhanced' options, which also include HCT features that are not yet widely available in the study area. Participants in Arm 3, an active control arm, will be offered the common option and three predicted 'less preferred' options. The primary outcome will be uptake of HIV testing.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Duke University Health System IRB, the University of South Carolina IRB, the Ethics Review Committee at Kilimanjaro Christian Medical University College, Tanzania's National Institute for Medical Research, and the Tanzania Food & Drugs Authority (now Tanzania Medicines & Medical Devices Authority). Findings will be published in peer-reviewed journals. The use of rigorous DCE methods for the preference-based design and tailoring of interventions could lead to novel policy options and implementation science approaches.
TRIAL REGISTRATION NUMBER


NCT02714140.",2020,"All participants will receive an HIV testing offer comprised of four preference-informed testing options, including one 'common' option-comprising features that are commonly available in the area and, on average, most preferred among study participants-and three options that are specific to the study arm.","['600 female barworkers and 600 male Kilimanjaro mountain porters across three study arms', 'undiagnosed persons living with HIV in Southern and Eastern Africa need to test for HIV', 'two high-risk populations', 'high-risk populations']",['HIV counselling and testing (HCT'],['uptake of HIV testing'],"[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0402671', 'cui_str': 'Porter'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001741', 'cui_str': 'Eastern Africa'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.223333,"All participants will receive an HIV testing offer comprised of four preference-informed testing options, including one 'common' option-comprising features that are commonly available in the area and, on average, most preferred among study participants-and three options that are specific to the study arm.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ostermann', 'Affiliation': 'Department of Health Services Policy & Management, University of South Carolina, Columbia, South Carolina, USA jano@mailbox.sc.edu.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hobbie', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Mtuy', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Masaki', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Aisa', 'Initials': 'A', 'LastName': 'Shayo', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'van Zwetselaar', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, Tanzania.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Masnick', 'Affiliation': 'Selway Labs, LLC, Barrington, Rhode Island, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flaherty', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Derek S', 'Initials': 'DS', 'LastName': 'Brown', 'Affiliation': 'Brown School, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Axel C', 'Initials': 'AC', 'LastName': 'Mühlbacher', 'Affiliation': 'Center for Health Policy & Inequalities Research, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Thielman', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, North Carolina, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039313']
1659,33158841,Correction: (Rad 8)Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled dosage trial (Latte Dosage Trial).,,2020,,['infants born late preterm'],['Correction: (Rad 8)Caffeine prophylaxis'],['intermittent hypoxaemia'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0406775', 'cui_str': 'Symmetrical dyschromatosis of extremities'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",,0.0637444,,[],BMJ open,['10.1136/bmjopen-2020-038271corr1']
1660,33171431,Expressive writing to combat distress associated with the COVID-19 pandemic in people with inflammatory bowel disease (WriteForIBD): A trial protocol.,"OBJECTIVE


A large proportion of patients with inflammatory bowel disease (IBD) receive immunosuppressive medication, may be at higher risk of complications if they contract SARS-CoV-2 virus, and therefore report high levels of COVID-19-related distress. This trial will evaluate a brief, evidence-based, online, group-based expressive writing intervention to reduce COVID-19-related distress in people living with IBD at the time of pandemic.
METHODS


A parallel double-blind randomised controlled trial will be conducted. Overall, up to 154 adult participants with IBD and mild-moderate distress will be recruited via patient organisations. Participants will be allocated to the expressive writing intervention or an active control group. All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention. The expressive writing group will participate in the evidenced-based 4-day writing program adapted from Pennebaker and Beall, 1986. The active control group will write about untherapeutic topics provided by researchers. Statistical analysis will be carried out on an intention-to-treat basis and will involve linear mixed effects models.
CONCLUSIONS


If successful, this simple intervention may bring personal and societal benefits, particularly because it is low cost, can be easily implemented online, ensuring social distancing, and be made widely available, during future disasters and to help with trauma-related distress in IBD.
TRIAL REGISTRATION


The trial has been prospectively registered in the Australian New Zealand Trial Registry - ACTRN12620000448943p.",2020,"All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention.","['patients with inflammatory bowel disease (IBD', '154 adult participants with IBD and mild-moderate distress', 'people living with IBD at the time of pandemic', 'people with inflammatory bowel disease (WriteForIBD']","['expressive writing intervention', 'Expressive writing', 'expressive writing intervention or an active control group']","['distress, quality of life, resilience, self-efficacy, social support and disease activity', 'COVID-19-related distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",154.0,0.343985,"All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention.","[{'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Mikocka-Walus', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia. Electronic address: mikocka@deakin.edu.au.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Olive', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia; IMPACT, School of Medicine, Deakin University, Geelong, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skvarc', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Beswick', 'Affiliation': 'Department of Gastroenterology, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Massuger', 'Affiliation': ""Crohn's & Colitis Australia, Melbourne, Australia.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Raven', 'Affiliation': ""Crohn's & Colitis Australia, Melbourne, Australia.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Emerson', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Subhadra', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110286']
1661,33180097,Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial.,"Importance


Coronavirus disease 2019 (COVID-19) may lead to serious illness as a result of an excessive immune response. Fluvoxamine may prevent clinical deterioration by stimulating the σ-1 receptor, which regulates cytokine production.
Objective


To determine whether fluvoxamine, given during mild COVID-19 illness, prevents clinical deterioration and decreases the severity of disease.
Design, Setting, and Participants


Double-blind, randomized, fully remote (contactless) clinical trial of fluvoxamine vs placebo. Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater. One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020. The final date of follow-up was September 19, 2020.
Interventions


Participants were randomly assigned to receive 100 mg of fluvoxamine (n = 80) or placebo (n = 72) 3 times daily for 15 days.
Main Outcomes and Measures


The primary outcome was clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.
Results


Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events.
Conclusions and Relevance


In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.
Trial Registration


ClinicalTrials.gov Identifier: NCT04342663.",2020,"Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009).","['adult outpatients with symptomatic COVID-19, patients treated with', 'One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020', 'Outpatients With Symptomatic COVID-19', 'Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater', '152 patients who were randomized (mean [SD] age, 46 [13] years', ' 109 [72%] women), 115 (76%) completed the trial']","['Fluvoxamine', 'fluvoxamine vs placebo', 'placebo', 'fluvoxamine', 'Placebo']","['oxygen saturation', 'clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less', 'serious adverse event', '6 serious adverse events', 'Clinical deterioration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0557143', 'cui_str': 'Lives in a community'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0085228', 'cui_str': 'Fluvoxamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",152.0,0.649931,"Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009).","[{'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Caline', 'Initials': 'C', 'LastName': 'Mattar', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Zorumski', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Schweiger', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Informatics Institute, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yingling', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Reiersen', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St Louis, St Louis, Missouri.'}]",JAMA,['10.1001/jama.2020.22760']
1662,33180098,"Effect of Vitamin B12 Injection on the Vocal Performance of Professional Singers: A Randomized, Double-blind, Placebo-Controlled, Crossover Trial.","Importance


One-third of singers and vocal professionals report experiencing a benefit from empirical vitamin B12 injections for improvement of mild singing-related symptoms (eg, reduced stamina, vocal fatigue, and effort). However, there is no objective evidence to support or refute these claims.
Objective


To assess the presence and magnitude of the effect of empirical vitamin B12 injection on the vocal performance of singers.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled, crossover trial was conducted from November 7, 2017, to November 30, 2018, at an academic voice center among 20 active adult singers without dysphonia but with mild vocal symptoms. Individuals with known or suspected vitamin B12 deficiency or active or recent vitamin B12 treatment were excluded. Analysis was on a per-protocol basis.
Interventions


Participants were randomized to receive an intramuscular (deltoid) injection of either vitamin B12 (1000 μg of cyanocobalmin) or placebo (0.9% sodium chloride). After a washout period of at least 4 weeks, participants were crossed over to receive the opposite injection. Both the investigators and participants were blinded to the order of injections.
Main Outcomes and Measures


The participants completed the Singing Voice Handicap Index-10 (SVHI-10), the Voice Fatigue Index (VFI), and the Evaluation of the Ability to Sing Easily (EASE) before each injection and at intervals of 1 hour, 3 hours, 24 hours, 72 hours, and 1 week after the injection. The primary time point assessment was 72 hours after injection, and the SVHI-10 score was the primary outcome measure.
Results


Twenty singers (10 men; median age, 22 years [range, 19-42 years]) were enrolled. The improvements after either placebo or vitamin B12 injections were comparable to each other. At 72 hours after the vitamin B12 injection, the median difference in the SVHI-10 score was 1 (95% CI, -1 to 2) compared with 3 (95% CI, 0-4) after placebo. The median difference between differences at 72 hours between placebo and vitamin B12 injections were 1.5 (95% CI, -2 to 5) for the SVHI-10, 1 (95% CI, -9 to 9) for the VFI, and -1 (95% CI, -3 to 2) for the EASE. The improvements after both injections failed to reach the estimated minimal clinically important difference. Of the 20 participants, 4 (20%) reached the estimated minimal clinically important difference in their SVHI-10 score after 72 hours for both vitamin B12 and placebo injections.
Conclusions and Relevance


This randomized, double-blind, placebo-controlled, crossover trial found that after empirical vitamin B12 injection to improve mild voice-related symptoms, the improvement in self-reported voice measures in singers shows no meaningful difference compared with placebo.
Trial Registration


ClinicalTrials.gov Identifier: NCT03437824.",2020,The improvements after either placebo or vitamin B12 injections were comparable to each other.,"['November 7, 2017, to November 30, 2018, at an academic voice center among 20 active adult singers without dysphonia but with mild vocal symptoms', 'Professional Singers', 'Results\n\n\nTwenty singers (10 men; median age, 22 years [range, 19-42 years]) were enrolled', 'Individuals with known or suspected vitamin B12 deficiency or active or recent vitamin B12 treatment were excluded']","['empirical vitamin B12 injection', 'vitamin B12 injection', 'Vitamin B12 Injection', 'placebo', 'intramuscular (deltoid) injection of either vitamin B12 (1000 μg of cyanocobalmin) or placebo (0.9% sodium chloride', 'placebo or vitamin B12 injections', 'Placebo', 'vitamin B12 injections']","['Singing Voice Handicap Index-10 (SVHI-10), the Voice Fatigue Index (VFI), and the Evaluation of the Ability to Sing Easily (EASE', 'vocal performance of singers', 'mild voice-related symptoms', 'SVHI-10 score', 'Vocal Performance']","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0335076', 'cui_str': 'Singer'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0042847', 'cui_str': 'Cobalamin deficiency'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0184615', 'cui_str': 'Injection of vitamin B12'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0241700', 'cui_str': 'Vocal fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0335076', 'cui_str': 'Singer'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.759751,The improvements after either placebo or vitamin B12 injections were comparable to each other.,"[{'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Shoffel-Havakuk', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Christian X', 'Initials': 'CX', 'LastName': 'Lava', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Reuven', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Rabin Medical Center, Petach Tikva, Israel.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Moog', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Odell', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Reder', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}, {'ForeName': 'Edie R', 'Initials': 'ER', 'LastName': 'Hapner', 'Affiliation': 'UAB Voice Center, Otolaryngology, University of Alabama, Birmingham.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Johns', 'Affiliation': 'USC Voice Center, Department of Otolaryngology-Head and Neck Surgery, University of Southern California, Los Angeles.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.4026']
1663,33176272,Partially randomized patient preference trial: Comparative evaluation of fibromyalgia between acupuncture and cupping therapy (PRPP-FACT).,"BACKGROUND


and purpose The aim of this study was to investigate the feasibility of applying a partially randomized patients' preference (PRPP) trial in the clinical evaluation of acupuncture versus cupping therapy for fibromyalgia.
MATERIALS AND METHODS


The final study included 126 participants. Participants without a treatment modality preference were randomly assigned to either the cupping therapy group or the acupuncture group. Patients with strong preferences were assigned to their treatment modality of choice. Ashi points were used for treatment. Outcome measures were both qualitative (patient expectation and satisfaction) and quantitative (drop-out rate, pain intensity, quality of life, depression assessment).
RESULTS


The recruitment of the non-randomized participants was completed 8 months before the randomized participants were recruited. There was no statistical difference related to the grouping method in the adjusted drop-out rate, patient expectation, and satisfaction.
CONCLUSION


The PRPP model is suitable for use in the clinical evaluation of non-pharmaceutical therapies.",2020,"There was no statistical difference related to the grouping method in the adjusted drop-out rate, patient expectation, and satisfaction.
","['Patients with strong preferences', 'Participants without a treatment modality preference', '126 participants']","['cupping therapy', 'acupuncture versus cupping therapy', 'acupuncture', 'acupuncture and cupping therapy (PRPP-FACT']","['qualitative (patient expectation and satisfaction) and quantitative (drop-out rate, pain intensity, quality of life, depression assessment', 'adjusted drop-out rate, patient expectation, and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",126.0,0.147234,"There was no statistical difference related to the grouping method in the adjusted drop-out rate, patient expectation, and satisfaction.
","[{'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Cao', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. Electronic address: huijuancao327@hotmail.com.'}, {'ForeName': 'Ya-Jing', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Institute of information and Literature, Jiangxi Insititute of Traditional Chinese Medicine, Jiangxi province, 330077, China. Electronic address: yajing_z@hotmail.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'The Department of Acupuncture and Metabolic Diseases, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China. Electronic address: zhouli02118@126.com.'}, {'ForeName': 'Zhan-Guo', 'Initials': 'ZG', 'LastName': 'Xie', 'Affiliation': ""The Department of Acupuncture and Moxibustion, First People's Hospital of Dongcheng District, Beijing, 100075, China. Electronic address: wodezhenjiu@163.com.""}, {'ForeName': 'Ru-Wen', 'Initials': 'RW', 'LastName': 'Zheng', 'Affiliation': 'The Department of Acupuncture and Metabolic Diseases, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China. Electronic address: zrw123@sina.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Department of Acupuncture and Metabolic Diseases, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China. Electronic address: huhui65@163.com.'}, {'ForeName': 'Xin-Lin', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'China Press of Traditional Chinese Medicine, Beijing, 100176, China. Electronic address: Lixinlinli2011@163.com.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Liu', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. Electronic address: jianping_l@hotmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101255']
1664,33176335,Performance of deep learning to detect mastoiditis using multiple conventional radiographs of mastoid.,"OBJECTIVES


This study aimed to compare the diagnostic performance of deep learning algorithm trained by single view (anterior-posterior (AP) or lateral view) with that trained by multiple views (both views together) in diagnosis of mastoiditis on mastoid series and compare the diagnostic performance between the algorithm and radiologists.
METHODS


Total 9,988 mastoid series (AP and lateral views) were classified as normal or abnormal (mastoiditis) based on radiographic findings. Among them 792 image sets with temporal bone CT were classified as the gold standard test set and remaining sets were randomly divided into training (n = 8,276) and validation (n = 920) sets by 9:1 for developing a deep learning algorithm. Temporal (n = 294) and geographic (n = 308) external test sets were also collected. Diagnostic performance of deep learning algorithm trained by single view was compared with that trained by multiple views. Diagnostic performance of the algorithm and two radiologists was assessed. Inter-observer agreement between the algorithm and radiologists and between two radiologists was calculated.
RESULTS


Area under the receiver operating characteristic curves of algorithm using multiple views (0.971, 0.978, and 0.965 for gold standard, temporal, and geographic external test sets, respectively) showed higher values than those using single view (0.964/0.953, 0.952/0.961, and 0.961/0.942 for AP view/lateral view of gold standard, temporal external, and geographic external test sets, respectively) in all test sets. The algorithm showed statistically significant higher specificity compared with radiologists (p = 0.018 and 0.012). There was substantial agreement between the algorithm and two radiologists and between two radiologists (κ = 0.79, 0.8, and 0.76).
CONCLUSION


The deep learning algorithm trained by multiple views showed better performance than that trained by single view. The diagnostic performance of the algorithm for detecting mastoiditis on mastoid series was similar to or higher than that of radiologists.",2020,The algorithm showed statistically significant higher specificity compared with radiologists (p = 0.018 and 0.012).,"['Among them 792 image sets with temporal bone CT were classified as the gold standard test set and remaining sets', 'Total 9,988 mastoid series (AP and lateral views) were classified as normal or abnormal (mastoiditis) based on radiographic findings']",['deep learning algorithm trained by single view (anterior-posterior (AP) or lateral view'],"['Diagnostic performance', 'diagnostic performance']","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039484', 'cui_str': 'Temporal bone structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0446908', 'cui_str': 'Mastoid structure'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",9988.0,0.0199454,The algorithm showed statistically significant higher specificity compared with radiologists (p = 0.018 and 0.012).,"[{'ForeName': 'Kyong Joon', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Inseon', 'Initials': 'I', 'LastName': 'Ryoo', 'Affiliation': 'Department of Radiology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dongjun', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Sung-Hye', 'Initials': 'SH', 'LastName': 'You', 'Affiliation': 'Department of Radiology, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Hye Na', 'Initials': 'HN', 'LastName': 'Jung', 'Affiliation': 'Department of Radiology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0241796']
1665,33159976,Multiple-dose clinical pharmacology of the selective orexin-1 receptor antagonist ACT-539313.,"AIMS


Compounds that selectively target orexin-1 receptors may be beneficial for the treatment of various disorders. The role of selective orexin-1 receptor antagonists (1-SORAs) in addictive behavior and stress/anxiety-related disturbances has been demonstrated in animals. ACT-539313, an orally active, potent 1-SORA, has been assessed in a clinical single-ascending dose study and exhibited good safety and tolerability. In the two reported studies on ACT-539313, multiple-dose pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability were investigated and in a proof-of-mechanism study a CO 2  challenge was applied as pharmacological model for induction of anxiety and panic symptoms (sequential inhalation of air, 7.5% CO 2 , and 35% CO 2 ).
METHODS


Two double-blind, placebo-controlled, randomized, multiple-dose studies included 58 healthy male and female subjects. In Study 1, multiple-ascending oral doses of 30, 100, and 200 mg twice daily (b.i.d.) ACT-539313 were investigated in 3 dose groups of 8 or 12 subjects (of whom 2 received placebo per dose group). Study 2 was conducted as a randomized two-way crossover design, enrolling 21 male and 9 female subjects who received 200 mg ACT-539313 or matching placebo b.i.d. for 2.5 days followed by a CO 2  challenge, with a washout period in between. PK, PD (objective and subjective measures of sedation, alertness, effects on central nervous system (CNS), and anxiety/panic symptoms), safety, and tolerability were assessed.
RESULTS


At steady state, ACT-539313 was rapidly absorbed with a median time to maximum plasma concentration of 1.8-2.3 h and eliminated with a mean half-life of 3.8-6.5 h. Overall exposure increased dose-proportionally. In Study 1, PD effects confirmed activity of ACT-539313 on the CNS, without consistent or marked effects of sedation, reduced alertness or visuo-motor impairment. In the CO 2  challenge, cortisol concentrations were lower during initial air inhalation after treatment with ACT-539313 compared to placebo, while no difference was detected after CO 2  inhalation. Trends for lower scores in subjective anxiety assessments were observed for ACT-539313. Besides reports of stress related to the challenge, the most frequently reported adverse events were somnolence and headache. No clinically relevant effects in other safety assessments were observed.
CONCLUSIONS


Multiple-dose administration of ACT-539313 was safe and well tolerated up to multiple doses of 200 mg b.i.d. The drug's PK properties as well as the pattern of a decrease in stress-related symptoms after the CO 2  challenge support further investigations of ACT-539313.",2020,"In the CO 2  challenge, cortisol concentrations were lower during initial air inhalation after treatment with ACT-539313 compared to placebo, while no difference was detected after CO 2  inhalation.","['enrolling 21 male and 9 female subjects who received 200\u202fmg', '58 healthy male and female subjects']","['ACT-539313', 'placebo', 'ACT-539313 or matching placebo b.i.d', 'selective orexin-1 receptor antagonists (1-SORAs']","['PK, PD (objective and subjective measures of sedation, alertness, effects on central nervous system (CNS), and anxiety/panic symptoms), safety, and tolerability', 'ACT-539313, multiple-dose pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability', 'safe and well tolerated', 'subjective anxiety assessments', 'cortisol concentrations', 'alertness or visuo-motor impairment']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1113688', 'cui_str': 'Orexin'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1275624', 'cui_str': 'Porzana carolina'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",21.0,0.0816893,"In the CO 2  challenge, cortisol concentrations were lower during initial air inhalation after treatment with ACT-539313 compared to placebo, while no difference was detected after CO 2  inhalation.","[{'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland. Electronic address: priska.kaufmann@idorsia.com.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ort', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmbH, Spandauer Damm 130, 14050, Berlin, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Spandauer Damm 130, 14050, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110166']
1666,33160091,Feasibility and preliminary efficacy of a positive psychology-based intervention to promote health behaviors in heart failure: The REACH for Health study.,"OBJECTIVE


Most patients with heart failure (HF) struggle to adhere to health behaviors, and existing health behavior interventions have significant limitations. We developed a 12-week, phone-delivered, combined positive psychology (PP) and motivational interviewing (MI) intervention to promote well-being and adherence to physical activity, diet, and medications. In this three-arm, randomized trial, we assessed the feasibility, acceptability, and preliminary efficacy of the intervention compared to treatment as usual and MI-alone conditions in 45 patients with HF and suboptimal health behavior adherence.
METHODS


Participants in the PP-MI or MI-alone conditions completed weekly phone sessions for 12 weeks. Those in PP-MI completed weekly PP exercises and set health behavior goals, while those in the MI-alone condition learned about HF-specific health behaviors and identified potential behavior changes. Primary study outcomes were feasibility (sessions completed) and acceptability (0-10 ratings of PP exercise ease and utility). The intervention's impact on psychological and behavioral outcomes was assessed using mixed effects regression analyses.
RESULTS


Participants in the PP-MI condition completed 73% of sessions and rated PP exercises as easy to complete (mean = 7.5 [SD 1.7] out of 10) and subjectively useful (mean = 7.5 [SD 1.6] out of 10). Compared to the control conditions, PP-MI led to medium effect-size improvements in positive affect (Cohen's d = 0.32-0.77), moderate to vigorous physical activity (d = 0.41-0.74), and medication adherence (d = 0.48-0.78).
CONCLUSION


This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes. Larger trials are needed to examine this intervention's impact on health behavior adherence and other important outcomes (NCT03220204).",2020,"This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes.","['patients with heart failure (HF', 'Participants in the PP-MI or MI-alone conditions completed weekly phone sessions for 12\xa0weeks', '45 patients with HF and suboptimal health behavior adherence', 'heart failure']","['positive psychology-based intervention', 'combined positive psychology (PP) and motivational interviewing (MI) intervention to promote well-being and adherence to physical activity, diet, and medications']","['health behavior adherence', 'feasibility (sessions completed) and acceptability (0-10 ratings of PP exercise ease and utility', 'psychological and behavioral outcomes', 'moderate to vigorous physical activity', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",45.0,0.039932,"This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. Electronic address: ccelano@mgh.harvard.edu.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Freedman', 'Affiliation': 'Department of Psychology, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Harnedy', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Baim Institute for Clinical Research, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA; Departments of Neurology and Biostatistics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110285']
1667,33160115,Safety and efficacy of apixaban thromboprophylaxis in cancer patients with metastatic disease: A post-hoc analysis of the AVERT trial.,"BACKGROUND


The risk of venous thromboembolism (VTE) is increased in patients with active cancer and the risk is highest in those with metastatic disease. The risks and benefits of thromboprophylaxis among cancer patients with metastatic disease initiating chemotherapy treatment are unknown. To address this important knowledge gap, we evaluated the efficacy and safety of apixaban thromboprophylaxis in patients with and without metastatic disease.
METHODS


Post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The hazards ratios (HRs) for VTE and major bleeding episodes in patients with and without metastatic disease were calculated using a Cox regression model controlling for age, gender, and center.
RESULTS


A total of 574 patients underwent randomization and 365 patients could be stratified according to the presence (n = 138) or absence (n = 227) of metastatic disease. In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo. In patients without metastatic disease, the use of apixaban was also associated with a significantly lower risk of VTE (HR 0.34 95% CI 0.19 to 0.60) without a significant increase in major bleeding complications (HR 1.14 95% CI 0.08 to 15.91).
CONCLUSIONS


In patients with and without metastatic disease, apixaban thromboprophylaxis was associated with a significantly lower rate of VTE compared to placebo.",2020,"In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo.","['patients with active cancer', 'cancer patients with metastatic disease initiating', 'patients with and without metastatic disease', 'cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy', '574 patients underwent randomization and 365 patients could be stratified according to the presence (n\xa0=\xa0138) or absence (n\xa0=\xa0227) of metastatic disease', 'cancer patients with metastatic disease']","['apixaban therapy to placebo', 'placebo', 'apixaban thromboprophylaxis', 'chemotherapy']","['hazards ratios (HRs) for VTE and major bleeding episodes', 'Safety and efficacy', 'efficacy and safety', 'rate of VTE', 'risk of VTE', 'major bleeding complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",574.0,0.339079,"In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Knoll', 'Affiliation': ""Faculty of Medicine, Queen's University, Kingston, Canada; Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada.""}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mcarrier@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.10.026']
1668,33162246,Treating Women with Recurrent Stress Urinary Incontinence: A Hornet's Nest Still Needing Proper Clinical Evidence.,Evidence is lacking on the best treatment for women presenting with recurrent stress urinary incontinence. PURSUIT is a randomised trial of urethral bulking agent injection versus surgical intervention. It will provide high-quality evidence to aid counselling and inform choice.,2020,PURSUIT is a randomised trial of urethral bulking agent injection versus surgical intervention.,"['Treating Women with Recurrent Stress Urinary Incontinence', 'women presenting with recurrent stress urinary incontinence']",['urethral bulking agent injection versus surgical intervention'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],,0.0567789,PURSUIT is a randomised trial of urethral bulking agent injection versus surgical intervention.,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Agur', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK; University Hospital Crosshouse, NHS Ayrshire and Arran, Kilmarnock, UK. Electronic address: wael.agur@glasgow.ac.uk.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Pope', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tamsin', 'Initials': 'T', 'LastName': 'Greenwell', 'Affiliation': 'Department of Urology, University College London Hospital, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Athene Lane', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'White', 'Affiliation': 'Patient and Public Involvement (PPI) Representative, University of Bristol, Bristol, UK.'}]",European urology,['10.1016/j.eururo.2020.10.030']
1669,33164349,Subcutaneous Sarilumab in Patients With Rheumatoid Arthritis who Previously Received Subcutaneous Sarilumab or Intravenous Tocilizumab: An Open-Label Extension of a Randomized Clinical Trial.,"OBJECTIVE


This post hoc analysis evaluated the safety and efficacy of open-label sarilumab in patients with rheumatoid arthritis (RA) who completed the phase III double-blind ASCERTAIN study (NCT01768572) and switched from intravenous (IV) tocilizumab to subcutaneous (SC) sarilumab, or who continued SC sarilumab in the open-label extension (OLE) study EXTEND (NCT01146652).
METHODS


Patients who completed ASCERTAIN were eligible to enroll in EXTEND to receive sarilumab 200 mg SC every 2 weeks (Q2W). Safety and efficacy were reported through 96 weeks in the OLE in patients who switched from tocilizumab IV to sarilumab 200 mg SC Q2W, who switched from sarilumab 150 mg SC Q2W to sarilumab 200 mg SC Q2W, or who continued sarilumab 200 mg SC Q2W.
RESULTS


Of 175 patients who completed ASCERTAIN, 168 (96%) enrolled in EXTEND, and 38 of these patients (23%) discontinued the OLE. Cumulative sarilumab exposure during follow-up was 273.7 patient-years. No new safety signals were identified, infections occurred at a rate of 59.9/100 patient-years, and there were no cases of grade 4 neutropenia. Efficacy-as assessed by Disease Activity Score (28 joints) based on C-reactive protein, Clinical Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores-was sustained over 96 weeks of follow-up when switching to, or continuing, sarilumab 200 mg SC Q2W.
CONCLUSION


Switching from IV to SC interleukin-6 receptor inhibitor therapy produced no new safety concerns, and clinical efficacy was sustained over 96 weeks of follow-up. These findings alleviate potential concerns over switching route of administration with interleukin-6 receptor inhibitor therapy for RA.",2020,"Efficacy-as assessed by Disease Activity Score (28 joints) based on C-reactive protein, Clinical Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores-was sustained over 96 weeks of follow-up when switching to, or continuing, sarilumab 200 mg SC Q2W.
CONCLUSION


","['patients with rheumatoid arthritis (RA', 'Patients With Rheumatoid Arthritis who Previously Received', '175 patients who completed ASCERTAIN, 168 (96%) enrolled in EXTEND, and 38 of these patients (23%) discontinued the OLE', 'Patients who completed']","['sarilumab 200\xa0mg SC Q2W, or who continued sarilumab 200\xa0mg SC Q2W', 'open-label sarilumab', 'interleukin-6 receptor inhibitor therapy', 'Subcutaneous Sarilumab or Intravenous Tocilizumab', 'tocilizumab to subcutaneous (SC) sarilumab, or who continued SC sarilumab', 'sarilumab 200\xa0mg SC', 'tocilizumab', 'Subcutaneous Sarilumab']","['Safety and efficacy', 'grade 4 neutropenia', 'safety and efficacy', 'Disease Activity Score (28 joints) based on C-reactive protein, Clinical Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0357103,"Efficacy-as assessed by Disease Activity Score (28 joints) based on C-reactive protein, Clinical Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores-was sustained over 96 weeks of follow-up when switching to, or continuing, sarilumab 200 mg SC Q2W.
CONCLUSION


","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'van Hoogstraten', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Karthinathan', 'Initials': 'K', 'LastName': 'Thangavelu', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mangan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'St John', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, New York.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Verschueren', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium and Skeletal Biology and Engineering Research Centre KU Leuven, Leuven, Belgium.'}]",ACR open rheumatology,['10.1002/acr2.11188']
1670,33164941,Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study.,"BACKGROUND


No pharmacological treatment has been demonstrated to provide a functional benefit for persons with Huntington's disease (HD). Pridopidine is a sigma-1-receptor agonist shown to have beneficial effects in preclinical models of HD.
OBJECTIVE


To further explore the effect of pridopidine on Total Functional Capacity (TFC) in the recent double-blind, placebo-controlled PRIDE-HD study.
METHODS


We performed post-hoc analyses to evaluate the effect of pridopidine on TFC at 26 and 52 weeks. Participants were stratified according to baseline TFC score and analyzed using repeated measures (MMRM) and multiple imputation assuming missing not-at-random (MNAR) and worst-case scenarios.
RESULTS


The pridopidine 45 mg bid dosage demonstrated a beneficial effect on TFC for the entire population at week 52 of 0.87 (nominal p = 0.0032). The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003). This effect remained nominally significant using multiple imputation with missing not at random assumption as a sensitivity analysis. Responder analyses showed pridopidine 45 mg bid reduced the probability of TFC decline in early HD patients at Week 52 (nominal p = 0.02).
CONCLUSION


Pridopidine 45 mg bid results in a nominally significant reduction in TFC decline at 52 weeks compared to placebo, particularly in patients with early-stage HD.",2020,"The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003).","[""persons with Huntington's disease (HD"", 'Early-Stage Participants from the PRIDE-HD Study']","['Pridopidine', 'pridopidine', 'placebo']","['Total Functional Capacity (TFC', 'probability of TFC decline', 'Functional Capacity', 'TFC decline']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1741584', 'cui_str': 'pridopidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.125887,"The effect was more pronounced for early HD participants (HD1/HD2, TFC = 7-13), with a change from placebo of 1.16 (nominal p = 0.0003).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Cooper University Healthcare at Rowan University, Camden, NJ, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clintrex Research Corporation, Sarasota, FL, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kieburtz', 'Affiliation': 'Clintrex Research Corporation, Sarasota, FL, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Geva', 'Affiliation': 'Prilenia Therapeutics, Herzliya, Israel.'}, {'ForeName': 'C Warren', 'Initials': 'CW', 'LastName': 'Olanow', 'Affiliation': 'Mount Sinai School of Medicine, New York City, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayden', 'Affiliation': 'Prilenia Therapeutics, Herzliya, Israel.'}]",Journal of Huntington's disease,['10.3233/JHD-200440']
1671,33160908,Opioid prescription for pain after osmotic dilator placement in abortion care: A randomized controlled trial.,"OBJECTIVE


To compare the overnight maximum pain scores after osmotic dilator placement prior to a dilation and evacuation (D&E) procedure in participants assigned to a prescription for ibuprofen alone or to ibuprofen plus oxycodone.
STUDY DESIGN


We conducted a nonblinded pragmatic, randomized controlled trial to evaluate pain management among women undergoing osmotic dilator placement prior to D&E. We randomly assigned 70 participants at 12 weeks 6 days to 23 weeks 6 days gestation to receive a prescription for ibuprofen alone, or ibuprofen plus oxycodone. We assessed pain using a numeric rating scale (NRS; scale 0-10) at the following time points: Baseline, dilator placement, 2 and 6 hours, and preoperatively, where we also asked participants their maximum pain score. The primary outcome was mean individual NRS pain score change from baseline to maximum pain score.
RESULTS


Maximum mean pain score (change from baseline) was 4.7 ± 2.9 in the ibuprofen group, and 6.5 ± 2.5 in the ibuprofen plus oxycodone group (p < 0.01). Participants in both groups reported highest NRS pain scores 2 hours after dilator placement, 3.9 ± 2.5 and 5.3 ± 2.6 respectively (p = 0.02). Average ibuprofen use in both arms was similar, and 81% of participants used at least 1 dose of ibuprofen after dilator placement. Of those randomized to prescription to ibuprofen plus oxycodone, only 51% used a dose of oxycodone.
CONCLUSIONS


Compared to participants randomized to receive a prescription for ibuprofen, those randomized to receive a prescription for ibuprofen plus oxycodone reported higher maximum overnight pain scores.
IMPLICATIONS


Participants receiving a prescription for ibuprofen alone had lower maximum overnight pain scores following osmotic dilator placement. Given that opioid prescriptions did not appear to reduce overnight pain, minimizing these prescriptions would avoid opioid exposure for patients undergoing D&E.",2020,"RESULTS


Maximum mean pain score (change from baseline) was 4.7± 2.9 in the ibuprofen group, and 6.5± 2.5 in the ibuprofen plus oxycodone group (p<0.01).","['participants assigned to a prescription for', 'pain after osmotic dilator placement in abortion care', 'women undergoing osmotic dilator placement prior to D&E']","['ibuprofen plus oxycodone', 'Opioid prescription', 'osmotic dilator placement prior to a dilation and evacuation (D&E) procedure', 'oxycodone', 'ibuprofen alone or to ibuprofen plus oxycodone', 'ibuprofen', 'ibuprofen alone, or ibuprofen plus oxycodone']","['maximum overnight pain scores', 'Maximum mean pain score', 'overnight maximum pain scores', 'highest NRS pain scores', 'maximum pain score', 'mean individual NRS pain score change from baseline to maximum pain score', 'pain using a numeric rating scale']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029391', 'cui_str': 'Osmosis'}, {'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0029391', 'cui_str': 'Osmosis'}, {'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",70.0,0.400701,"RESULTS


Maximum mean pain score (change from baseline) was 4.7± 2.9 in the ibuprofen group, and 6.5± 2.5 in the ibuprofen plus oxycodone group (p<0.01).","[{'ForeName': 'Divyah', 'Initials': 'D', 'LastName': 'Nagendra', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schurr', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States. Electronic address: arden.mcallister@pennmedicine.upenn.edu.'}, {'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Roe', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Shorter', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}]",Contraception,['10.1016/j.contraception.2020.10.019']
1672,33161162,"Deconstructing depression and negative symptoms of schizophrenia; differential and longitudinal immune correlates, and response to minocycline treatment.","BACKGROUND


Immune dysfunction has been implicated in negative symptoms of schizophrenia and also in depression. These disorders are frequently co-morbid, with some symptoms such as anhedonia and apathy common to both. The anti-inflammatory agent minocycline may be ineffective in schizophrenia, but more positive effects have been seen in depression. Our aim was to investigate the role of immune dysfunction in depression and sub-domains of negative symptoms in schizophrenia by investigating their intercorrelation and the influence of treatment with minocycline.
METHODS


We analysed longitudinal data from 207 patients within 5 years of onset of schizophrenia, from the randomised double-blind, placebo-controlled trial of minocycline (BeneMin). Symptom ratings and circulating IL-6, C-reactive protein (CRP) and TNF-α concentrations were collected at baseline and repeated over twelve months. The sample was not stratified by CRP prior to randomisation. Positive and Negative Syndrome Scale composite ratings of avolition-apathy and diminished expression, Calgary Depression Scale total scores, and immune markers were examined cross-sectionally using Spearman's rank, and longitudinally by linear mixed effect models that included body mass index and minocycline. Additionally, post hoc analysis of the sample stratified by elevated CRP (>1 mg/l and <10 mg/l at baseline) was carried out to assess whether minocycline had any effect on specific symptoms in an immune active sub-group of patients.
RESULTS


Depression and avolition-apathy were significantly positively related, and depression correlated weakly with IL-6 at baseline. Diminished expression was associated with increased TNF-α both cross-sectionally and longitudinally. CRP was unrelated to any symptom domain. Minocycline did not affect any individual symptom or sub-domain in the full sample or in the immune active sub-group.
DISCUSSION


IL-6 may have some specificity to depression in early schizophrenia. TNF-α may be an indicator of immune dysfunction relevant to negative symptoms, and our longitudinal findings add to this evidence. However, minocycline continues to show very little promise as a treatment for any symptom dimension of early schizophrenia.",2020,"Minocycline did not affect any individual symptom or sub-domain in the full sample or in the immune active sub-group.
",['207 patients within 5 years of onset of schizophrenia'],"['minocycline (BeneMin', 'placebo', 'Minocycline', 'TNF-α', 'minocycline']","['Positive and Negative Syndrome Scale composite ratings of avolition-apathy and diminished expression, Calgary Depression Scale total scores, and immune markers', 'Symptom ratings and circulating IL-6, C-reactive protein (CRP) and TNF-α concentrations', 'CRP', 'specific symptoms', 'Depression and avolition-apathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3495892', 'cui_str': 'Avolition'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}, {'cui': 'C0429688', 'cui_str': 'Symptom ratings'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",207.0,0.13509,"Minocycline did not affect any individual symptom or sub-domain in the full sample or in the immune active sub-group.
","[{'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': 'Krynicki', 'Affiliation': 'Institute for Mental Health, University of Birmingham, UK. Electronic address: c.krynicki@bham.ac.uk.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Dazzan', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ""Stress, Psychiatry and Immunology Lab & Perinatal Psychiatry, The Maurice Wohl Clinical Neuroscience Institute, King's College London, London, UK.""}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Barnes', 'Affiliation': 'Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Vincent', 'Affiliation': 'Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Institute of Clinical Sciences, College of Medical and Dental Sciences, University of Birmingham, UK.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'The Department of Clinical and Motor Neuroscience, UCL Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Suckling', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, Herchel Smith Building for Brain and Mind Sciences, University of Cambridge, UK; Cambridgeshire & Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Thomas R E', 'Initials': 'TRE', 'LastName': 'Barnes', 'Affiliation': 'Centre for Psychiatry, Imperial College London, London, UK.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK; MAHSC, The University of Manchester, Manchester, UK; Lancashire & South Cumbria NHS Foundation Trust, Accrington, UK.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Jones', 'Affiliation': 'Brain Mapping Unit, Department of Psychiatry, Herchel Smith Building for Brain and Mind Sciences, University of Cambridge, UK; Cambridgeshire & Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Joyce', 'Affiliation': 'The Department of Clinical and Motor Neuroscience, UCL Queen Square Institute of Neurology, London, UK.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Lawrie', 'Affiliation': 'Division of Psychiatry, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Shôn', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK; MAHSC, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Upthegrove', 'Affiliation': ""Institute for Mental Health, University of Birmingham, UK; Forward Thinking Birmingham, Birmingham Women's and Children's Hospital NHS Foundation Trust, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.10.026']
1673,33161276,A novel multi-study intervention investigating the short and long term effects of a posture bra on whole body and breast kinematics.,"BACKGROUND


Poor standing posture has been reported in women with larger breasts, increasing the risk of back pain. Whilst breast reduction surgery can improve posture, conservative measures such as special bras may offer short or long-term relief of symptoms without surgical intervention.
RESEARCH QUESTION


This study aimed to utilise a multi-study intervention to investigate the short and long-term kinematic effects of wearing a posture bra.
METHODS


Study one utilised biomechanics and physiotherapy expertise to modify the design of a prototype bra to improve posture and breast kinematics; resulting in a second-generation posture bra. To test this bra, 24 females were randomly assigned to control and intervention groups. The control group wore their everyday bra; the intervention group wore the generation 2 posture bra in place of their everyday bra for three months. Pre and post intervention, posture (spine curvature, scapula position, whole body alignment) and breast kinematics were assessed during sitting, standing and walking. Short-term effects of the posture bra were compared to an everyday bra and no bra (study two), whilst the long-term effects were compared using the no bra condition (study three).
RESULTS


Biomechanical intervention improved posture and breast kinematics in a prototype posture bra resulting in a second-generation prototype. Pre-intervention, the generation 2 posture bra significantly improved scapula retraction by 6° during both sitting and standing, but also increased deviation of whole body alignment compared to everyday bra and no bra conditions. During walking the posture bra reduced breast motion by 17 % compared to the everyday bra. Following the three-month wearer intervention, scapula depression significantly improved in the intervention group.
SIGNIFICANCE


A biomechanically informed posture bra was able to effectively support the breasts and improve scapula position without compromising spinal curvature, reducing the risk of musculoskeletal pain associated with poor posture.",2020,"Pre-intervention, the generation 2 posture bra significantly improved scapula retraction by 6° during both sitting and standing, but also increased deviation of whole body alignment compared to everyday bra and no bra conditions.","['24 females', 'women with larger breasts']","['wearing a posture bra', 'Biomechanical intervention', 'control group wore their everyday bra; the intervention group wore the generation 2 posture bra in place of their everyday bra for three months']","['Pre and post intervention, posture (spine curvature, scapula position, whole body alignment) and breast kinematics', 'breast motion', 'scapula depression', 'scapula retraction', 'posture and breast kinematics']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0235648', 'cui_str': 'Breast enlargement female'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]",24.0,0.0262088,"Pre-intervention, the generation 2 posture bra significantly improved scapula retraction by 6° during both sitting and standing, but also increased deviation of whole body alignment compared to everyday bra and no bra conditions.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom. Electronic address: chris.mills@port.ac.uk.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Exell', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wakefield-Scurr', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom.'}]",Gait & posture,['10.1016/j.gaitpost.2020.10.031']
1674,33166580,The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathy.,"A cyclical corticosteroid-cyclophosphamide regimen is recommended for patients with primary membranous nephropathy at high risk of progression. We hypothesized that sequential therapy with tacrolimus and rituximab is superior to cyclical alternating treatment with corticosteroids and cyclophosphamide in inducing persistent remission in these patients. This was tested in a randomized, open-label controlled trial of 86 patients with primary membranous nephropathy and persistent nephrotic syndrome after six-months observation and assigned 43 each to receive six-month cyclical treatment with corticosteroid and cyclophosphamide or sequential treatment with tacrolimus (full-dose for six months and tapering for another three months) and rituximab (one gram at month six). The primary outcome was complete or partial remission of nephrotic syndrome at 24 months. This composite outcome occurred in 36 patients (83.7%) in the corticosteroid-cyclophosphamide group and in 25 patients (58.1%) in the tacrolimus-rituximab group (relative risk 1.44; 95% confidence interval 1.08 to 1.92). Complete remission at 24 months occurred in 26 patients (60%) in the corticosteroid-cyclophosphamide group and in 11 patients (26%) in the tacrolimus-rituximab group (2.36; 1.34 to 4.16). Anti-PLA2R titers showed a significant decrease in both groups but the proportion of anti-PLA2R-positive patients who achieved immunological response (depletion of anti-PLA2R antibodies) was significantly higher at three and six months in the corticosteroid-cyclophosphamide group (77% and 92%, respectively), as compared to the tacrolimus-rituximab group (45% and 70%, respectively). Relapses occurred in one patient in the corticosteroid-cyclophosphamide group, and three patients in the tacrolimus-rituximab group. Serious adverse events were similar in both groups. Thus, treatment with corticosteroid-cyclophosphamide induced remission in a significantly greater number of patients with primary membranous nephropathy than tacrolimus-rituximab.",2020,"Anti-PLA2R titers showed a significant decrease in both groups but the proportion of anti-PLA2R-positive patients who achieved immunological response (depletion of anti-PLA2R antibodies) was significantly higher at three and six months in the corticosteroid-cyclophosphamide group (77% and 92%, respectively), as compared to the tacrolimus-rituximab group (45% and 70%, respectively).","['primary membranous nephropathy', '86 patients with primary membranous nephropathy and persistent nephrotic syndrome after six-months observation and assigned 43 each to receive six-month cyclical treatment with', 'patients with primary membranous nephropathy at high risk of progression']","['corticosteroids and cyclophosphamide', 'cyclical corticosteroid-cyclophosphamide regimen', 'tacrolimus and rituximab', 'tacrolimus-rituximab', 'corticosteroid-cyclophosphamide', 'corticosteroid and cyclophosphamide or sequential treatment with tacrolimus (full-dose for six months and tapering for another three months) and rituximab']","['complete or partial remission of nephrotic syndrome', 'immunological response (depletion of anti-PLA2R antibodies', 'Serious adverse events', 'Relapses', 'Complete remission']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C1670125', 'cui_str': 'PLA2R1 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",86.0,0.0910007,"Anti-PLA2R titers showed a significant decrease in both groups but the proportion of anti-PLA2R-positive patients who achieved immunological response (depletion of anti-PLA2R antibodies) was significantly higher at three and six months in the corticosteroid-cyclophosphamide group (77% and 92%, respectively), as compared to the tacrolimus-rituximab group (45% and 70%, respectively).","[{'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Fernández-Juárez', 'Affiliation': 'Hospital Universitario Fundación Alcorcón, Madrid.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rojas-Rivera', 'Affiliation': 'Hospital Universitario Fundación Jiménez Díaz, Madrid.'}, {'ForeName': 'Anne-Els van de', 'Initials': 'AV', 'LastName': 'Logt', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Justino', 'Affiliation': ""Université Côte d'Azur, CNRS, Institut de Pharmacologie Moléculaire et Cellulaire (IPMC), Valbonne Sophia Antipolis, France.""}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Sevillano', 'Affiliation': 'Instituto de Investigación Hospital Universitario 12 Octubre, Madrid.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Caravaca-Fontán', 'Affiliation': 'Instituto de Investigación Hospital Universitario 12 Octubre, Madrid.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ávila', 'Affiliation': 'Hospital Dr. Peset, Valencia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rabasco', 'Affiliation': 'Hospital Reina Sofía, Córdoba.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Cabello', 'Affiliation': 'Hospital Virgen del Rocío, Sevilla.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Varela', 'Affiliation': 'Hospital Virgen de la Victoria de Málaga.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Díez', 'Affiliation': 'Fundació Puigvert, Autonomous University of Barcelona, Institut Investigació Biosanitaria Sant Pau, (UAB).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Martín-Reyes', 'Affiliation': 'Hospital Regional Universitario de Málaga, Málaga.'}, {'ForeName': 'Marian Goicoechea', 'Initials': 'MG', 'LastName': 'Diezhandino', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid.'}, {'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Quintana', 'Affiliation': 'Centro de Referencia en Enfermedad Glomerular Compleja del Sistema Nacional de Salud (CSUR) Hospital Clínic de Barcelona, Universitat de Barcelona.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Agraz', 'Affiliation': 'Hospital Universitari Vall d´Hebron, Barcelona.'}, {'ForeName': 'Juan Ramón', 'Initials': 'JR', 'LastName': 'Gómez-Martino', 'Affiliation': 'Hospital San Pedro de Alcántara, Cáceres.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': 'Hospital Universitario de A Coruña, A Coruña.'}, {'ForeName': 'Antolina', 'Initials': 'A', 'LastName': 'Rodríguez-Moreno', 'Affiliation': 'Hospital Clínico San Carlos, Madrid.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Rivas', 'Affiliation': 'Hospital Universitario La Paz, Madrid.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Galeano', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Bonet', 'Affiliation': 'Hospital Germans Trias i Pujol, Barcelona.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Romera', 'Affiliation': 'Hospital de Ciudad Real, Ciudad Real.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Shabaka', 'Affiliation': 'Hospital Universitario Fundación Alcorcón, Madrid.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Plaisier', 'Affiliation': 'Sorbonne Université, Université Pierre et Marie Curie Paris 06, and Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche S1155, Paris, France; Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique- Hôpital de Jour Néphrologie - Hôpital TENON-APHP-Sorbonne Université.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Espinosa', 'Affiliation': 'Hospital Reina Sofía, Córdoba.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Egido', 'Affiliation': 'Hospital Universitario Fundación Jiménez Díaz, Madrid.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Segarra', 'Affiliation': 'Hospital Universitari Vall d´Hebron, Barcelona.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lambeau', 'Affiliation': ""Université Côte d'Azur, CNRS, Institut de Pharmacologie Moléculaire et Cellulaire (IPMC), Valbonne Sophia Antipolis, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Ronco', 'Affiliation': 'Sorbonne Université, Université Pierre et Marie Curie Paris 06, and Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche S1155, Paris, France; Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique- Hôpital de Jour Néphrologie - Hôpital TENON-APHP-Sorbonne Université.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wetzels', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Praga', 'Affiliation': 'Instituto de Investigación Hospital Universitario 12 Octubre, Madrid; Department of Medicine, Complutense University, Madrid. Electronic address: mpragat@senefro.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2020.10.014']
1675,33166726,Short-interval intracortical inhibition as a function of inter-stimulus interval: Three methods compared.,"BACKGROUND


Short-interval intracortical inhibition (SICI), as measured by threshold-tracking as a function of inter-stimulus interval (ISI), has been proposed as a useful biomarker for amyotrophic lateral sclerosis (ALS), but its relationship to conventional amplitude measurements has not been established.
METHODS


Serial tracking of SICI at increasing ISIs from 1 to 7 ms (T-SICIs) was compared in 50 healthy control subjects with the same ISIs tracked in parallel (T-SICIp), and with conventional amplitude measurements (A-SICI). For T-SICIp and A-SICI, pairs of conditioning and test stimuli with different ISIs were pseudo-randomised and interspersed with test-alone stimuli given at regular intervals. Thresholds were estimated by regression of log peak-to-peak amplitude on stimulus.
RESULTS


T-SICIp and A-SICI were closely related: a ten-fold reduction in amplitude corresponding to an approximately 18% increase in threshold. Threshold increases were greater for T-SICIs than for T-SICIp at 3.5-5 ms (P < 0.001). This divergence depended on the initial settings and whether ISIs were progressively increased or decreased, and was attributed to the limitations of the serial tracking protocol. SICI variability between subjects was greatest for T-SICIs estimates and least for A-SICI, and only A-SICI estimates revealed a significant decline in inhibition with age.
CONCLUSIONS


The serial tracking protocol did not accurately show the dependence of inhibition on ISI. Randomising ISIs gives corresponding SICI measures, whether tracking thresholds or measuring amplitude measurements. SICI variability suggested that A-SICI measurements may be the most sensitive to loss of inhibition.",2020,"SICI variability between subjects was greatest for T-SICIs estimates and least for A-SICI, and only A-SICI estimates revealed a significant decline in inhibition with age.
","['50 healthy control subjects with the same ISIs tracked in parallel (T-SICIp), and with conventional amplitude measurements (A-SICI']",[],['SICI variability'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",50.0,0.0606434,"SICI variability between subjects was greatest for T-SICIs estimates and least for A-SICI, and only A-SICI estimates revealed a significant decline in inhibition with age.
","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Tankisi', 'Affiliation': 'Department of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Cengiz', 'Affiliation': 'Department of Neurology, Gazi University Faculty of Medicine, Beşevler, 06500, Ankara, Turkey.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Howells', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gintaute', 'Initials': 'G', 'LastName': 'Samusyte', 'Affiliation': 'Department of Neurology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Koltzenburg', 'Affiliation': 'Department of Clinical and Movement Neuroscience, UCL Queen Square Institute of Neurology, Queen Square, WC1N 3BG, London, United Kingdom; Department of Clinical Neurophysiology, National Hospital for Neurology and Neurosurgery, Queen Square, WC1N 3BG, London, United Kingdom.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Bostock', 'Affiliation': 'Department of Neuromuscular Diseases, UCL Queen Square Institute of Neurology, Queen Square, WC1N 3BG, London, United Kingdom. Electronic address: H.Bostock@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.11.002']
1676,33166769,The Effect of Hyperglycemia on Infarct Growth after Reperfusion: An Analysis of the DEFUSE 3 trial.,"BACKGROUND AND PURPOSE


Brain infarct growth, despite successful reperfusion, decreases the likelihood of good functional outcome after ischemic stroke. In patients undergoing reperfusion, admission glucose is associated with poor outcome but the effect of glucose level on infarct growth is not well studied.
MATERIALS AND METHODS


This is a secondary analysis of the DEFUSE 3 trial. The primary predictor was baseline glucose level and the primary outcome is the change of the ischemic core volume from the baseline to 24-hour follow-up imaging (∆core), transformed as a cube root to reduce right skew. We included DEFUSE 3 patients who were randomized to endovascular therapy, had perfusion imaging data at baseline, an MRI at 24 hours, and who achieved TICI 2b or 3. Linear regression models, both unadjusted and adjusted, were fit to the primary outcome and all models included the baseline core volume as a covariate to normalize ∆core.
RESULTS


We identified 62 patients who met our inclusion criteria. The mean age was 68.1±13.1 (years), 48.4% (30/62) were men, and the median (IQR) cube root of ∆core was 2.8 (2.0-3.8) mL. There was an association between baseline glucose level and normalized ∆core in unadjusted analysis (beta coefficient 0.010, p = 0.01) and after adjusting for potential confounders (beta coefficient 0.008, p = 0.03).
CONCLUSION


In acute ischemic stroke patients with large vessel occlusion undergoing successful endovascular reperfusion, baseline hyperglycemia is associated with infarction growth. Further study is needed to establish potential neuroprotective benefits of aggressive glycemic control prior to and after reperfusion.",2020,"There was an association between baseline glucose level and normalized ∆core in unadjusted analysis (beta coefficient 0.010, p = 0.01) and after adjusting for potential confounders (beta coefficient 0.008, p = 0.03).
","['62 patients who met our inclusion criteria', 'Infarct Growth after Reperfusion', 'acute ischemic stroke patients with large vessel occlusion undergoing successful endovascular reperfusion, baseline hyperglycemia', 'The mean age was 68.1±13.1 (years), 48.4% (30/62) were men, and the median (IQR) cube root of ∆core was 2.8 (2.0-3.8) mL']","['Hyperglycemia', 'endovascular therapy']","['change of the ischemic core volume from the baseline to 24-hour follow-up imaging (∆core), transformed as a cube root to reduce right skew', 'baseline glucose level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",62.0,0.177349,"There was an association between baseline glucose level and normalized ∆core in unadjusted analysis (beta coefficient 0.010, p = 0.01) and after adjusting for potential confounders (beta coefficient 0.008, p = 0.03).
","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'Department of Neurology, NYU Langone Health, 150 55th St Suite 3667, Brooklyn, NY 11220, USA. Electronic address: Shadi.yaghi@nyulangone.org.'}, {'ForeName': 'Seena', 'Initials': 'S', 'LastName': 'Dehkharghani', 'Affiliation': 'Department of Radiology, NYU Langone Health, New York, NY, United States. Electronic address: Seena.Dehkharghani@nyulangone.org.'}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Raz', 'Affiliation': 'Department of Radiology, NYU Langone Health, New York, NY, United States. Electronic address: Eytan.raz@nyulangone.org.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaraman', 'Affiliation': 'Department of Neurology, Brown University, Providence, RI, United States; Department of Radiology, Brown University, Providence, RI, United States; Department of Neuorosurgery, Brown University, Providence, RI, United States. Electronic address: Mahesh.jayaraman@gmail.com.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Tanweer', 'Affiliation': 'Department of Neurosurgery, NYU Langone Health, New York, NY, United States. Electronic address: Omar.tanweer@nyulangone.org.'}, {'ForeName': 'Brian Mac', 'Initials': 'BM', 'LastName': 'Grory', 'Affiliation': 'Department of Neurology, Duke University, Durham, NC, United States. Electronic address: brian.macgrory@duke.edu.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Henninger', 'Affiliation': 'Department of Neurology, University of Massachusetts, Worcester, MA, United States; Department of Psychiatry, University of Massachusetts, Worcester, MA, United States. Electronic address: nils.henninger@umassmed.edu.'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Department of Neurology, Stanford University, San Francisco, CA, United States. Electronic address: Lansberg@stanford.edu.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Department of Neurology, Stanford University, San Francisco, CA, United States. Electronic address: albers@stanford.edu.'}, {'ForeName': 'Adam de', 'Initials': 'A', 'LastName': 'Havenon', 'Affiliation': 'Department of Neurology, University of Utah Medical Center, Salt Lake City, UT, United States. Electronic address: adam.dehavenon@hsc.utah.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105380']
1677,33167687,CORRIGENDUM: The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial.,,2020,,['heart failure with reduced ejection fraction'],['home-based rehabilitation'],[],"[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",[],,0.166517,,[],European journal of preventive cardiology,['10.1177/2047487320974256']
1678,33167705,One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.,"BACKGROUND


Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.
METHODS


Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.
RESULTS


Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% ( P <0.001).
CONCLUSIONS


Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.",2020,"One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.
","['high bleeding risk (HBR) patients after drug-eluting stents', 'HBR patients', 'Onyx', 'High-Bleeding-Risk Patients', 'patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria', 'HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents']","['Zotarolimus-Eluting Stents', 'guidance endorsing shortened dual antiplatelet therapy (DAPT', 'DAPT', 'zotarolimus-eluting stents']","['cardiac death or myocardial infarction', 'DAPT adherence and without major adverse events', 'Mean HBR characteristics', 'safety and effectiveness of 1-month DAPT duration', 'safety and effectiveness']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",1506.0,0.045226,"One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.
","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA (D.E.K.).'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Department of Interventional Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital (A.J.K., T.N.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiovascular Diseases, University Hospital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Department of Interventional Cardiology, Montefiore Medical Center, New York, NY (A.L.).'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Department of Cardiology, Isala Zwolle, the Netherlands (E.K.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Department of Cardiology, School of Medicine at Mount Sinai, New York, NY (R.M., G.W.S.).'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Price', 'Affiliation': 'Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P.).'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': 'Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (A.A.).'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Simon', 'Affiliation': 'Department of Interventional Cardiology, University Hospitals Cleveland Medical Center, OH (D.I.S.).'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Worthley', 'Affiliation': 'Department of Cardiology, GenesisCare, Alexandria, Australia (S.G.W.).'}, {'ForeName': 'Azfar', 'Initials': 'A', 'LastName': 'Zaman', 'Affiliation': 'Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.).'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Interventional Cardiology, Baylor Scott and White Heart and Vascular Hospital, Dallas, TX (J.W.C.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Caputo', 'Affiliation': ""Department of Interventional Cardiology, St. Joseph's Hospital, Syracuse, NY (R.C.).""}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kanitkar', 'Affiliation': 'Department of Interventional Cardiology, Huntsville Hospital, AL (M.K.).'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'McLaurin', 'Affiliation': 'Department of Interventional Cardiology, Anmed Health Medical Center, Anderson, SC (B.M.).'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Potluri', 'Affiliation': 'Department of Interventional Cardiology, The Heart Hospital Baylor Plano, TX (S.P.).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Department of Interventional Cardiology, The Christ Hospital, Cincinnati, OH (T.S.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Spriggs', 'Affiliation': 'Department of Interventional Cardiology, Morton Plant Hospital, Clearwater, FL (D.S.).'}, {'ForeName': 'Thaddeus', 'Initials': 'T', 'LastName': 'Tolleson', 'Affiliation': 'Department of Cardiology, UT Health East Texas, Tyler (T.T.).'}, {'ForeName': 'Tamim', 'Initials': 'T', 'LastName': 'Nazif', 'Affiliation': 'Department of Interventional Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital (A.J.K., T.N.).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Parke', 'Affiliation': 'Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.).'}, {'ForeName': 'Lilian C', 'Initials': 'LC', 'LastName': 'Lee', 'Affiliation': 'Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.).'}, {'ForeName': 'Te-Hsin', 'Initials': 'TH', 'LastName': 'Lung', 'Affiliation': 'Coronary and Structural Heart Division, Medtronic, Santa Rosa, CA (M.P., L.C.L., T.-H.L.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY (A.J.K., G.W.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009565']
1679,33177131,Effectiveness of deep electroacupuncture with strong deqi and shallow electroacupuncture with no deqi for lumbar disk herniation: study protocol for a randomised controlled trial.,"INTRODUCTION


Lumbar disk herniation (LDH) is a common cause of low back pain and dysfunction. Studies have shown that electroacupuncture (EA) can achieve pain relief in patients with LDH. However, there is a lack of evidence regarding the effectiveness of deep EA with strong deqi and shallow EA with no deqi in patients with LDH. This study aims to evaluate the effectiveness of deep EA with strong deqi and shallow EA with no deqi in the treatment of LDH.
METHODS AND ANALYSIS


In this randomised controlled trial, patients with LDH who have low back pain with or without radiculopathy for at least 12 weeks will be enrolled. In total, 44 patients will be recruited from the Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China. Patients will be randomised into the deep EA group and the shallow EA group in a ratio of 1:1 and will be administered 12 sessions of EA treatment (three times a week for 4 weeks, 20 min for each session). The follow-up duration will be 4 weeks. Low back pain intensity and leg pain intensity (in patients with radicular pain) measured using the Visual Analogue Scale (VAS) will be assessed as the primary outcomes. Function (measured using the Roland-Morris Disability Questionnaire), quality of life (measured using the EuroQol Five-Dimensional Five-Level Questionnaire) and patient-evaluated therapeutic effect will be assessed as the secondary outcomes. Patients' expectations of EA, the success of the blinding method and safety will also be evaluated. Statistical analyses will be followed by the intention-to-treat analysis.
ETHICS AND DISSEMINATION


This study was approved by the Ethics Committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine (approval number: 2019-XS-ZB06). Study results will be disseminated through publication in an open access journal.
TRIAL REGISTRATION NUMBER


ChiCTR-1900026518.",2020,Low back pain intensity and leg pain intensity (in patients with radicular pain) measured using the Visual Analogue Scale (VAS) will be assessed as the primary outcomes.,"['patients with LDH', '44 patients will be recruited from the Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China', 'patients with radicular pain', 'lumbar disk herniation', 'patients with LDH who have low back pain with or without radiculopathy for at least 12 weeks will be enrolled', 'Ethics Committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine (approval number: 2019-XS-ZB06']","['deep electroacupuncture with strong deqi and shallow electroacupuncture with no deqi', 'shallow EA', 'electroacupuncture (EA', 'deep EA with strong deqi and shallow EA']","['Visual Analogue Scale (VAS', 'Function (measured using the Roland-Morris Disability Questionnaire), quality of life', 'Low back pain intensity and leg pain intensity', 'pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",44.0,0.17298,Low back pain intensity and leg pain intensity (in patients with radicular pain) measured using the Visual Analogue Scale (VAS) will be assessed as the primary outcomes.,"[{'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China beijingzhaojianxin@163.com.'}, {'ForeName': 'Xinghong', 'Initials': 'X', 'LastName': 'Pei', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Bobo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture, The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-036528']
1680,33177133,"Effects of Creative Expressive Arts-based Storytelling (CrEAS) programme on older adults with mild cognitive impairment: protocol for a randomised, controlled three-arm trial.","INTRODUCTION


Early non-pharmacological interventions can prevent cognitive decline in older adults with mild cognitive impairment (MCI). Creative expression (CrExp) can potentially mitigate cognitive decline and enhance the physical and mental health of older people. However, it is unclear whether activities involving CrExp can improve cognitive function and other health-related outcomes in older adults with MCI. The aim of the present study is to develop a Creative Expressive Arts-based Storytelling (CrEAS) programme that integrates verbal and non-verbal expressive activities and evaluate its effectiveness in improving cognitive function and other outcome indicators so as to explore its possible mechanism from the perspective of neuroimaging.
METHODS AND ANALYSIS


This parallel randomised controlled trial with three arms (one intervention and two control arms) will be conducted over a 24-week period. A total of 111 participants will be enrolled and randomised to the CrEAS, recreation and usual activity groups. The CrEAS programme combines visual arts therapy and storytelling (TimeSlips) under the Expressive Therapy Continuum theoretical framework and provides an opportunity for people with MCI to actively engage in activities to improve cognitive function through verbal and nonverbal CrExp. Global cognitive function, specific domains of cognition (memory, executive function, language and attention) and other health-related outcomes (anxiety, depression and quality of life) will be measured at baseline, at the end of the intervention, and at the 24-week follow-up. Structural/functional brain MRI data will be collected at baseline and immediately after the intervention.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of Fujian Provincial Hospital (K2018-03-061). The study results will be disseminated through peer-reviewed journals and at academic conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900021526.",2020,"However, it is unclear whether activities involving CrExp can improve cognitive function and other health-related outcomes in older adults with MCI.","['older adults with mild cognitive impairment (MCI', 'Fujian Provincial Hospital', 'older adults with MCI', '111 participants will be enrolled and randomised to the CrEAS, recreation and usual activity groups', 'older adults with mild cognitive impairment']","['Creative expression (CrExp', 'CrEAS programme combines visual arts therapy and storytelling (TimeSlips', 'Creative Expressive Arts-based Storytelling (CrEAS) programme']","['Global cognitive function, specific domains of cognition (memory, executive function, language and attention) and other health-related outcomes (anxiety, depression and quality of life', 'cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0003827', 'cui_str': 'Art therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",111.0,0.134465,"However, it is unclear whether activities involving CrExp can improve cognitive function and other health-related outcomes in older adults with MCI.","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yuan-Jiao', 'Initials': 'YJ', 'LastName': 'Yan', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Luo', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Cai', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Kai-Yan', 'Initials': 'KY', 'LastName': 'Zhu', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The School of Nursing, Fujian Medical University, Fuzhou, Fujian, China leehong99@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-036915']
1681,33177134,"Investigating a new tablet-based telerehabilitation app in patients with aphasia: a randomised, controlled, evaluator-blinded, multicentre trial protocol.","INTRODUCTION


Aphasia is a common language disorder acquired after stroke that reduces the quality of life of affected patients. The impairment is frequently accompanied by a deficit in cognitive functions. The state-of-the-art therapy is speech and language therapy but recent findings highlight positive effects of high-frequency therapy. Telerehabilitation has the potential to enable high-frequency therapy for patients at home. This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training. We hypothesise that patients training with high-frequency teleSLT will show higher improvement in language functions and quality of life compared with patients with high-frequency tele-rehabilitative cognitive training (teleCT).
METHODS AND ANALYSIS


This study is a randomised controlled, evaluator-blinded multicentre superiority trial comparing the outcomes following either high-frequency teleSLT or teleCT. A total of 100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups. Both groups will train over a period of 4 weeks for 2 hours per day. Patients in the experimental condition will devote 80% of their training time to teleSLT and the remaining 20% (24 min/day) to teleCT, vice versa for patients in the control condition. The primary outcome measure is the understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming. Other outcomes measures are quality of life and acceptance (usability and subjective experience) of the teleSLT system.
ETHICS AND DISSEMINATION


This study is approved by the Ethics Committee Bern (ID 2016-01577). Results will be submitted to a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03228264.",2020,This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training.,"['outpatients with aphasia compared with telerehabilitative cognitive training', '100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups', 'patients with aphasia']","['high-frequency telerehabilitation speech and language therapy (teleSLT', 'high-frequency teleSLT or teleCT']","['language functions', 'understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming', 'language functions and quality of life', 'quality of life and acceptance (usability and subjective experience) of the teleSLT system', 'quality of life']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0450991', 'cui_str': 'ANELT'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1444674', 'cui_str': 'Confrontation visual field test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0037831', 'cui_str': 'Speech therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",100.0,0.236305,This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training.,"[{'ForeName': 'Arif Sinan', 'Initials': 'AS', 'LastName': 'Uslu', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Gerber', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Schmidt', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Röthlisberger', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patric', 'Initials': 'P', 'LastName': 'Wyss', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Vanbellingen', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schaller', 'Affiliation': 'Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Wyss', 'Affiliation': 'Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Koenig-Bruhin', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nyffeler', 'Affiliation': 'Neurocenter, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Müri', 'Affiliation': 'Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nef', 'Affiliation': 'ARTORG Center for Biomedical Engineering, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Prabitha', 'Initials': 'P', 'LastName': 'Urwyler', 'Affiliation': 'Gerontechnology and Rehabilitation Group, University of Bern, Bern, Switzerland prabitha.urwyler@artorg.unibe.ch.'}]",BMJ open,['10.1136/bmjopen-2020-037702']
1682,33177138,"Discontinuing antidepressant medication after mindfulness-based cognitive therapy: a mixed-methods study exploring predictors and outcomes of different discontinuation trajectories, and its facilitators and barriers.","OBJECTIVES


This study aimed to explore predictors and outcomes associated with different trajectories of discontinuing antidepressant medication (ADM), in recurrently depressed individuals after participation in mindfulness-based cognitive therapy (MBCT). Facilitators and barriers of discontinuation were explored qualitatively.
DESIGN


Mixed-methods study combining quantitative and qualitative data, drawn from a randomised controlled trial.
SETTING


Twelve secondary and tertiary psychiatric outpatient clinics in the Netherlands.
PARTICIPANTS


Recurrently depressed individuals (N=226) who had been using ADM for at least 6 months and in partial or full remission. Regardless of trial condition, we made  post-hoc  classifications of patients' actual discontinuation trajectories: full discontinuation (n=82), partial discontinuation (n=34) and no discontinuation (n=110) of ADM within 6 months after baseline. A subset of patients (n=15) and physicians (n=7) were interviewed to examine facilitators and barriers of discontinuation.
INTERVENTIONS


All participants were offered MBCT, which consisted of eight weekly sessions in a group.
PRIMARY AND SECONDARY OUTCOME MEASURES


Demographic and clinical predictors of successful discontinuation within 6 months, relapse risk within 15 months associated with different discontinuation trajectories, and barriers and facilitators of discontinuation.
RESULTS


Of the 128 patients assigned to MBCT with discontinuation, only 68 (53%) fully discontinued ADM within 6 months, and 17 (13%) discontinued partially. Predictors of full discontinuation were female sex, being employed and lower levels of depression. Relapse risk was lower after no discontinuation (45%) or partial discontinuation (38%), compared with full discontinuation (66%) (p=0.02). Facilitators and barriers of discontinuation were clustered within five themes: (1) pre-existing beliefs about depression, medication and tapering; (2) current experience with ADM; (3) life circumstances; (4) clinical support and (5) mindfulness.
CONCLUSIONS


Discontinuing antidepressants appears to be difficult, stressing the need to support patients and physicians in this process. MBCT may offer one of these forms of support.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT00928980); post-results.",2020,"Relapse risk was lower after no discontinuation (45%) or partial discontinuation (38%), compared with full discontinuation (66%) (p=0.02).","['Twelve secondary and tertiary psychiatric outpatient clinics in the Netherlands', 'Recurrently depressed individuals (N=226) who had been using ADM for at least 6\u2009months and in partial or full remission', ""patients' actual discontinuation trajectories: full discontinuation (n=82), partial discontinuation (n=34) and no discontinuation (n=110) of ADM within 6\u2009months after baseline"", '128 patients assigned to', 'A subset of patients (n=15) and physicians (n=7']","['mindfulness-based cognitive therapy (MBCT', 'Discontinuing antidepressant medication after mindfulness-based cognitive therapy', 'MBCT', 'discontinuing antidepressant medication (ADM']","['Relapse risk', 'successful discontinuation within 6 months, relapse risk within 15 months associated with different discontinuation trajectories, and barriers and facilitators of discontinuation']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",7.0,0.0417688,"Relapse risk was lower after no discontinuation (45%) or partial discontinuation (38%), compared with full discontinuation (66%) (p=0.02).","[{'ForeName': 'Marloes J', 'Initials': 'MJ', 'LastName': 'Huijbers', 'Affiliation': 'Psychiatry, Radboudumc, Nijmegen, Gelderland, The Netherlands marloes.huijbers@radboudumc.nl.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Wentink', 'Affiliation': 'Psychiatry, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Simons', 'Affiliation': 'Primary and Community Care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Spijker', 'Affiliation': 'Expertise Centre for Depression, Pro Persona Locatie Tarweweg, Nijmegen, Gelderland, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Speckens', 'Affiliation': 'Psychiatry, Radboudumc, Nijmegen, Gelderland, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-039053']
1683,33181415,Severe or critical hypotension during post cardiac arrest care is associated with factors available on admission - a post hoc analysis of the TTH48 trial.,"PURPOSE


We explored whether severe or critical hypotension can be predicted, based on patient and resuscitation characteristics in out-of-hospital cardiac arrest (OHCA) patients. We also explored the association of hypotension with mortality and neurological outcome.
MATERIALS AND METHODS


We conducted a post hoc analysis of the TTH48 study (NCT01689077), where 355 out-of-hospital cardiac arrest (OHCA) patients were randomized to targeted temperature management (TTM) treatment at 33 °C for either 24 or 48 h. We recorded hypotension, according to four severity categories, within four days from admission. We used multivariable logistic regression analysis to test association of admission data with severe or critical hypotension.
RESULTS


Diabetes mellitus (OR 3.715, 95% CI 1.180-11.692), longer ROSC delay (OR 1.064, 95% CI 1.022-1.108), admission MAP (OR 0.960, 95% CI 0.929-0.991) and non-shockable rhythm (OR 5.307, 95% CI 1.604-17.557) were associated with severe or critical hypotension. Severe or critical hypotension was associated with increased mortality and poor neurological outcome at 6 months.
CONCLUSIONS


Diabetes, non-shockable rhythm, longer delay to ROSC and lower admission MAP were predictors of severe or critical hypotension. Severe or critical hypotension was associated with poor outcome.",2020,"Severe or critical hypotension was associated with increased mortality and poor neurological outcome at 6 months.
","['Diabetes mellitus (OR', 'We conducted a post hoc analysis of the TTH48 study (NCT01689077), where 355 out-of-hospital cardiac arrest (OHCA) patients', 'out-of-hospital cardiac arrest (OHCA) patients']",['targeted temperature management (TTM'],"['Severe or critical hypotension', 'admission MAP', 'mortality and poor neurological outcome', 'severe or critical hypotension', 'longer ROSC delay (OR']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.054264,"Severe or critical hypotension was associated with increased mortality and poor neurological outcome at 6 months.
","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland. Electronic address: johanna.hastbacka@hus.fi.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kirkegaard', 'Affiliation': 'Research Center for Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eldar', 'Initials': 'E', 'LastName': 'Søreide', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Stavanger University Hospital, Stavanger, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Aalborg University Hospital, and Clinical Institute, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Storm', 'Affiliation': 'Department of Internal Medicine, Nephrology and Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Laitio', 'Affiliation': 'Division of Perioperative Services, Intensive Care Medicine and Pain Management, Turku University Hospital and University of Turku, Finland.'}, {'ForeName': 'Christophe Henri Valdemar', 'Initials': 'CHV', 'LastName': 'Duez', 'Affiliation': 'Research Center for Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anni N', 'Initials': 'AN', 'LastName': 'Jeppesen', 'Affiliation': 'Research Center for Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anders M', 'Initials': 'AM', 'LastName': 'Grejs', 'Affiliation': 'Research Center for Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital and Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Skrifvars', 'Affiliation': 'Department of Emergency Care and Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",Journal of critical care,['10.1016/j.jcrc.2020.10.026']
1684,33181456,Smartwatches are more distracting than mobile phones while driving: Results from an experimental study.,"The use of smartwatches raises a number of questions about their potential for distraction in situations where sustained attention is paramount, like driving a motor vehicle. Our research examines distraction caused by smartwatch use in comparison to mobile phone use while driving. It also studies the difference in distractions caused by inbound text messages versus inbound voice messages, and outbound replies through text messages versus outbound voice replies. A within-subject experiment was conducted in a driving simulator where 31 participants received and answered text messages under four conditions: they received notifications (1) on a mobile phone, (2) on a smartwatch, and (3) on a speaker, and then responded orally to these messages. They also (4) received messages in a ""texting"" condition where they had to reply through text to the notifications. Eye tracking gaze distribution results show that participants were more distracted in the smartwatch condition than in the mobile phone condition, they were less distracted in the speaker condition than in the phone condition, and they were more distracted in the texting condition than in any of the others. The participants' driving performance remained the same in all conditions except in the texting condition, wherein it became worse. Eye tracking and pupillometry results suggest that participants' mental workload might be lower in the texting condition than in the other three conditions, although this result might be caused by a higher number of glances at the device in that condition. This study contributes to a better understanding of the distraction potential of smartwatches as well as identifying vocal assistants as the least distracting way of communicating while driving a vehicle. Industry leaders could become a key factor in informing the public of the smartwatch's potential for distraction.",2020,"Eye tracking gaze distribution results show that participants were more distracted in the smartwatch condition than in the mobile phone condition, they were less distracted in the speaker condition than in the phone condition, and they were more distracted in the texting condition than in any of the others.",[],[],[],[],[],[],31.0,0.0253588,"Eye tracking gaze distribution results show that participants were more distracted in the smartwatch condition than in the mobile phone condition, they were less distracted in the speaker condition than in the phone condition, and they were more distracted in the texting condition than in any of the others.","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Brodeur', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: mathieu.2.brodeur@hec.ca.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Ruer', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: perrine.ruer@hec.ca.'}, {'ForeName': 'Pierre-Majorique', 'Initials': 'PM', 'LastName': 'Léger', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: pierre-majorique.leger@hec.ca.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Sénécal', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: sylvain.senecal@hec.ca.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105846']
1685,33161045,High intensity interval training does not result in short- or long-term dietary compensation in cardiac rehabilitation: Results from the FITR heart study.,"The aim of this study was to investigate short- and long-term compensatory effects on dietary intake following high intensity interval training (HIIT) compared with usual care moderate intensity continuous training (MICT) during and following a cardiac rehabilitation program. This study investigates secondary outcomes of a clinical trial. Ninety-three participants with coronary artery disease enrolled in a 4-week cardiac rehabilitation program, were randomised to 1) 4x4-minute HIIT; or 2) 40-min of MICT (usual care). Patients were instructed to complete 3 weekly sessions (2 supervised, 1 home-based) for 4-weeks, and 3 weekly home-based sessions thereafter for another 48-weeks. Dietary intake was measured by telephone-based 24-h recall over 2 day at baseline, 4-weeks, 3-months, 6-months, and 12-months. Three-Factor Eating Questionnaire was used to measure dietary behaviour and Leeds Food Preference Questionnaire used to measure food preferences. Appetite was assessed by a visual analogue scale and appetite-regulating hormones. There was no change over the study period or differences between groups for daily energy intake at 4-weeks or 12-months. There were also no group differences for any other measures of dietary intake, fasting hunger or appetite-related hormones, dietary behaviour, or food preferences. These findings suggest that compared to moderate intensity exercise, HIIT does not result in compensatory increases of energy intake or indicators of poor diet quality. This finding appears to be the same for patients with normal weight and obesity. HIIT can therefore be included in cardiac rehabilitation programs as an adjunct or alterative to MICT, without concern for any undesirable dietary compensation.",2020,"There were also no group differences for any other measures of dietary intake, fasting hunger or appetite-related hormones, dietary behaviour, or food preferences.","['Ninety-three participants with coronary artery disease enrolled in a 4-week cardiac rehabilitation program, were randomised to 1) 4x4-minute', 'cardiac rehabilitation', 'patients with normal weight and obesity']","['MICT (usual care', 'usual care moderate intensity continuous training (MICT', 'High intensity interval training', 'high intensity interval training (HIIT']","['Appetite', 'visual analogue scale and appetite-regulating hormones', 'dietary intake, fasting hunger or appetite-related hormones, dietary behaviour, or food preferences', 'Dietary intake', 'daily energy intake']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",93.0,0.039733,"There were also no group differences for any other measures of dietary intake, fasting hunger or appetite-related hormones, dietary behaviour, or food preferences.","[{'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia; Cardiac Rehabilitation Department, The Wesley Hospital, Brisbane, Australia. Electronic address: jenna.taylor@uqconnect.edu.au.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia. Electronic address: s.keating@uq.edu.au.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Holland', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia; Department of Cardiology, Sunshine Coast University Hospital, Birtinya, Australia. Electronic address: d.holland@uq.edu.au.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, United Kingdom. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'King', 'Affiliation': 'Queensland University of Technology Institute of Health and Biomedical Innovation, Brisbane, Australia. Electronic address: n.king@qut.edu.au.'}, {'ForeName': 'Sjaan R', 'Initials': 'SR', 'LastName': 'Gomersall', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia; School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia. Electronic address: s.gomersall1@uq.edu.au.'}, {'ForeName': 'Alex V', 'Initials': 'AV', 'LastName': 'Rowlands', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, United Kingdom; NIHR Leicester Biomedical Research Centre, United Kingdom. Electronic address: alex.rowlands@leicester.ac.uk.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia. Electronic address: jcoombes@uq.edu.au.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Leveritt', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia. Electronic address: michael.leveritt@uq.edu.au.'}]",Appetite,['10.1016/j.appet.2020.105021']
1686,33161367,The influence of oral language environment on auditory development.,"OBJECTIVE


The purpose of this study was to compare the auditory processing of hearing children who were immersed in an oral language environment during early childhood with that of children who were poorly exposed to oral language during the same period.
METHODS


Sixty children aged between 5 and 10 years participated in this study. They were divided in two groups. Group 1 comprised of 30 children who had deaf signer parents, and Group 2 comprised of 30 children who had hearing parents. These children underwent the following auditory processing tests: Pediatric Speech Intelligibility, Dichotic Digits, Pitch Pattern Sequence, Gaps-in-Noise, and Memory Tests for Instrumental and Verbal sounds.
RESULTS


Group 1 had significantly poorer performance than that of Group 2 in all tests. In addition, an analysis by age range revealed that the differences between groups were more pronounced in younger children (5-6 years).
CONCLUSION


The results indicate that the development of auditory skills is strongly influenced by access to oral linguistic sounds. Thus, a child's exposure to an oral language environment from birth is important to the adequate development of the auditory system functions.",2020,"RESULTS


Group 1 had significantly poorer performance than that of Group 2 in all tests.","['Sixty children aged between 5 and 10 years participated in this study', 'hearing children who were immersed in an oral language environment during early childhood with that of children who were poorly exposed to oral language during the same period', '30 children who had deaf signer parents, and Group 2 comprised of 30 children who had hearing parents']",['oral language environment'],"['auditory processing', 'auditory development', 'Speech Intelligibility, Dichotic Digits, Pitch Pattern Sequence, Gaps-in-Noise, and Memory Tests for Instrumental and Verbal sounds']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]",60.0,0.0281878,"RESULTS


Group 1 had significantly poorer performance than that of Group 2 in all tests.","[{'ForeName': 'Thaís Regina', 'Initials': 'TR', 'LastName': 'Monteiro', 'Affiliation': 'Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil. Electronic address: thais.remonteiro@usp.br.'}, {'ForeName': 'Caroline Nunes', 'Initials': 'CN', 'LastName': 'Rocha-Muniz', 'Affiliation': 'Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil. Electronic address: carolrocha@usp.br.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Filippini', 'Affiliation': 'Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil. Electronic address: refilippini.rf@gmail.com.'}, {'ForeName': 'Aline Albuquerque', 'Initials': 'AA', 'LastName': 'Morais', 'Affiliation': 'Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil. Electronic address: aline.fonoaudio@gmail.com.'}, {'ForeName': 'Eliane', 'Initials': 'E', 'LastName': 'Schochat', 'Affiliation': 'Faculdade de Medicina, Universidade de São Paulo (USP), São Paulo, SP, Brazil. Electronic address: eschocha@usp.br.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110426']
1687,33166622,Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) - Study protocol for a randomized controlled trial.,"BACKGROUND


There is strong evidence that disparities in the burden of diabetes exist by both race and poverty. Food insecurity, or an inability to or limitation in accessing nutritionally adequate food, is an important modifiable social determinant of health, particularly in adults with chronic disease. African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure.
METHODS


We describe a 4-year ongoing randomized controlled trial, which will test the separate and combined efficacy of monthly food vouchers and monthly food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, African Americans with type 2 diabetes mellitus using a 2 × 2 factorial design. Three hundred African American adults with clinical diagnosis of diabetes and HbA1c ≥ 8% will be randomized into one of four groups: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus stock boxes; and 4) diabetes education plus combined food vouchers and stock boxes. Our primary hypothesis is: among low-income, food insecure, African Americans with type 2 diabetes, those receiving diabetes education enhanced with food supplementation (food vouchers alone, stock boxes alone, or combination) will have significantly greater reduction in HbA1c at 12 months compared to those receiving diabetes education only.
DISCUSSION


Results from this study will yield valuable insight currently lacking on how best to design and deliver diabetes interventions to low-income, food insecure, African Americans with diabetes that takes into account both clinical and social determinants of health.
TRIAL REGISTRATION


This study was registered on November 29, 2019 with the United States National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT04181424).",2020,"African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure.
","['low income, food insecure, African Americans with type 2 diabetes mellitus', 'African Americans with type 2 diabetes', 'adults with chronic disease', 'Three hundred African American adults with clinical diagnosis of diabetes and HbA1c\u202f≥\u202f8', 'African American adults with type 2 diabetes mellitus (LIFT-DM', 'November 29, 2019 with the United States National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT04181424', 'African Americans']","['monthly food vouchers and monthly mailed food stock boxes layered upon diabetes education', 'diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus stock boxes; and 4) diabetes education plus combined food vouchers and stock boxes']",[],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",[],300.0,0.113214,"African Americans are more likely to be diagnosed with diabetes and more likely than whites to be food insecure.
","[{'ForeName': 'Rebekah J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States of America; Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, United States of America. Electronic address: rebwalker@mcw.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Knapp', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States of America. Electronic address: knappr@musc.edu.'}, {'ForeName': 'Clara E', 'Initials': 'CE', 'LastName': 'Dismuke-Greer', 'Affiliation': 'Health Economics Resource Center (HERC), VA Palo Alto Health Care System, Palo Alto, CA, United States of America. Electronic address: clara.dismuke@va.gov.'}, {'ForeName': 'Renee E', 'Initials': 'RE', 'LastName': 'Walker', 'Affiliation': 'Zilber School of Public Health, University of Wisconsin at Milwaukee, Milwaukee, WI, United States of America. Electronic address: walker36@uwm.edu.'}, {'ForeName': 'Mukoso N', 'Initials': 'MN', 'LastName': 'Ozieh', 'Affiliation': 'Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, United States of America; Division of Nephrology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States of America; Division of Nephrology, Clement J. Zablocki VA Medical Center, Milwaukee, WI, United States of America. Electronic address: mozieh@mcw.edu.'}, {'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Egede', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States of America; Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, United States of America. Electronic address: legede@mcw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106206']
1688,33166694,"Post-exposure prophylaxis with hydroxychloroquine for the prevention of COVID-19, a myth or a reality? The PEP-CQ Study.","Many drugs have been tried for the treatment/prevention of COVID-19 with limited success. Direct household contacts of COVID-19 patients are at highest risk for SARS-CoV-2 infection. Hydroxychloroquine (HCQ) has been tried against COVID-19 owing to its in vitro virucidal action against SARS-CoV-2, but the role of HCQ as post-exposure prophylaxis (PEP) remains inconclusive. In this open-label, controlled clinical trial, asymptomatic individuals who had direct contact with laboratory-confirmed COVID-19 cases or had undertaken international travel in the last 2 weeks were offered HCQ prophylaxis and assigned to PEP (n = 132) or control (n = 185) group. The PEP group received HCQ 800 mg on Day 1 followed by 400 mg once weekly for 3 weeks. Both groups undertook home quarantine for 2 weeks along with social distancing and personal hygiene. Over 4-week follow-up, 50/317 participants (15.8%) had new-onset COVID-19. The incidence of COVID-19 was significantly (P = 0.033) lower in the PEP (14/132; 10.6%) compared to the control (36/185; 19.5%) group (total absolute risk reduction, -8.9% points). The NNT to prevent the occurrence of 1 COVID-19 case was 12. Overall relative risk was 0.59 (95% CI 0.33-1.05). Compliance was good. The most common adverse event was epigastric discomfort with burning sensation (three participants), with no serious adverse events. PEP with HCQ has the potential for the prevention of COVID-19 in at-risk individuals. Until definitive therapy is available, continuing PEP with HCQ may be considered in suitable at-risk individuals. Further randomised clinical trials with larger samples are required for better evaluation of HCQ as PEP for COVID-19 prevention.",2020,"The incidence of COVID-19 was significantly (p=0.033) lower in PEP group [N=14 out of 132, (10.6%)] as compared to the control group [N=36 out of 185, (19.4%)].",['Total 50 out of 317 participants (15.8%) had new onset COVID-19'],"['Hydroxychloroquine (HCQ', 'tablet HCQ', 'PEP with HCQ']","['incidence of COVID-19', 'Total absolute risk reduction', 'overall relative risk', 'epigastric discomfort with burning sensation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}]",317.0,0.0487297,"The incidence of COVID-19 was significantly (p=0.033) lower in PEP group [N=14 out of 132, (10.6%)] as compared to the control group [N=36 out of 185, (19.4%)].","[{'ForeName': 'Deba Prasad', 'Initials': 'DP', 'LastName': 'Dhibar', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India. Electronic address: drdeba_prasad@yahoo.co.in.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Arpit', 'Initials': 'A', 'LastName': 'Kakkar', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ritin', 'Initials': 'R', 'LastName': 'Mohindra', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Suri', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bhalla', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mini P', 'Initials': 'MP', 'LastName': 'Singh', 'Affiliation': 'Department of Virology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Prakash', 'Affiliation': 'Department of Pharmacology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Pvm', 'Affiliation': 'Community Medicine and School of Public Health, PGIMER, Chandigarh, India.'}, {'ForeName': 'Bikash', 'Initials': 'B', 'LastName': 'Medhi', 'Affiliation': 'Department of Pharmacology, PGIMER, Chandigarh, India.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106224']
1689,33166858,Effect of middle ear gelfoam on hearing and healing process after tympanoplasty: A prospective randomized case-control study.,"PURPOSE


This prospective randomized case-control study was performed to compare the surgical outcomes of our swing-door overlay tympanoplasty with or without absorbable gelatine sponge (AGS, gelfoam) packing in the middle ear cavity, according to the surgical procedure.
METHODS


Fifty-seven patients who underwent swing-door overlay tympanoplasty by a single surgeon were enrolled in the study. The data of 30 patients of the gelfoam-packing group (GPG) and 27 patients of the non-gelfoam-packing group (NGPG) were prospectively collected and compared.
RESULTS


Closure of the tympanic membrane was found to be successful in all patients at postoperative 3 months evaluation. NGPG showed a statistically better healing process compared to GPG; earlier epithelialization and less fascia edema in NGPG than in GPG (P < 0.05). The air-bone gap (ABG) measured at postoperative 1 and 2 months was smaller in NGPG than GPG, although there were no statistical differences.
CONCLUSION


This study revealed earlier healing process and faster recovery of ABG in NGPG, thereby indicating that the gelfoam in the middle ear may interfere with both hearing recovery and the healing process of neodrum.",2020,NGPG showed a statistically better healing process compared to GPG; earlier epithelialization and less fascia edema in NGPG than in GPG (P ,"['30 patients of the gelfoam-packing group (GPG) and 27 patients of the non-gelfoam-packing group (NGPG', 'Fifty-seven patients who underwent swing-door overlay tympanoplasty by a single surgeon were enrolled in the study']","['swing-door overlay tympanoplasty with or without absorbable gelatine sponge (AGS, gelfoam) packing', 'NGPG', 'middle ear gelfoam', 'GPG (P']","['fascia edema', 'hearing and healing process', 'air-bone gap (ABG']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0444456', 'cui_str': 'Overlay'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0444456', 'cui_str': 'Overlay'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0393591', 'cui_str': 'Aicardi Goutieres syndrome'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}]",57.0,0.0155667,NGPG showed a statistically better healing process compared to GPG; earlier epithelialization and less fascia edema in NGPG than in GPG (P ,"[{'ForeName': 'Jae Sang', 'Initials': 'JS', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Ju', 'Initials': 'JJ', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yahya Dhafer', 'Initials': 'YD', 'LastName': 'AlAhmari', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Mee', 'Initials': 'JM', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Gangneung Asan Hospital, College of Medicine University of Ulsan, Gangneung, Republic of Korea.'}, {'ForeName': 'Jae-Hyun', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Shi Nae', 'Initials': 'SN', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: snparkmd@catholic.ac.kr.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102767']
1690,33166870,Testing a gamified Spider App to reduce spider fear and avoidance.,"Mobile applications are increasingly part of mental health programs and various apps have been developed for treating anxiety disorders. Typically, they aim to improve anxiety symptoms via established CBT techniques, such as exposure principles, which are considered extremely unpleasant for fearful individuals. We combined in a mobile application exposure principles with gamification elements (e.g. narrative background, level progression, points, and feedback). These elements should increase the motivation for confronting spider images and decrease the experienced distress. To evaluate the application, two groups of spider-fearful individuals played either the Spider App (experimental group) or a non-spider associated app (control group) twice a day for approximately 12 min for 7 days. After this week, participants of the experimental group showed less avoidance behavior of spiders (BAT), as well as lower anxiety of spiders (SPQ, FAS). Groups were not different in measures of depression or psychological distress. Interestingly, participants playing the Spider App reported higher anxiety, disgust and arousal ratings shortly after playing the app. However, anxiety, disgust, and arousal ratings decreased from day to day. We discuss our findings with respect to implications for the clinical practice.",2020,Groups were not different in measures of depression or psychological distress.,[],['Spider App (experimental group) or a non-spider associated app (control group) twice a day for approximately 12\u202fmin for 7 days'],"['spider fear and avoidance', 'anxiety, disgust, and arousal ratings', 'lower anxiety of spiders (SPQ, FAS', 'higher anxiety, disgust and arousal ratings', 'depression or psychological distress', 'avoidance behavior of spiders (BAT']",[],"[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}]",,0.0157851,Groups were not different in measures of depression or psychological distress.,"[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Haberkamp', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: anke.haberkamp@staff.uni-maburg.de.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Walter', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: Walterha@students.uni-marburg.de.'}, {'ForeName': 'Phillipp', 'Initials': 'P', 'LastName': 'Althaus', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: Althausp@students.uni-marburg.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schmuck', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: Schmuckm@students.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: rief@staff.uni-marburg.de.'}, {'ForeName': 'Filipp', 'Initials': 'F', 'LastName': 'Schmidt', 'Affiliation': 'Justus-Liebig-University, Giessen, Germany. Electronic address: Filipp.Schmidt@psychol.uni-giessen.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102331']
1691,33167882,"Financial incentives versus standard of care to improve patient compliance with live kidney donor follow-up: protocol for a multi-center, parallel-group randomized controlled trial.","BACKGROUND


Live kidney donors (LKDs) account for nearly a third of kidney transplants in the United States. While donor nephrectomy poses minimal post-surgical risk, LKDs face an elevated adjusted risk of developing chronic diseases such as hypertension, diabetes, and end-stage renal disease. Routine screening presents an opportunity for the early detection and management of chronic conditions. Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Strategies to increase patient engagement in follow-up efforts while minimizing administrative burden are needed. We seek to evaluate the effectiveness of using small financial incentives to promote patient compliance with LKD follow-up.
METHODS/DESIGN


We are conducting a two-arm randomized controlled trial (RCT) of patients who undergo live donor nephrectomy at The Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) and the University of Maryland Medical Center Transplant Center (MDUM). Eligible donors will be recruited in-person at their first post-surgical clinic visit or over the phone. We will use block randomization to assign LKDs to the intervention ($25 gift card at each follow-up visit) or control arm (current standard of care). Follow-up compliance will be tracked over time. The primary outcome will be complete (all components addressed) and timely (60 days before or after expected visit date), submission of LKD follow-up data at required 6-month, 1-year, and 2-year time points. The secondary outcome will be transplant hospital-level compliance with federal reporting requirements at each visit. Rates will be compared between the two arms following the intention-to-treat principle.
DISCUSSION


Small financial incentivization might increase patient compliance in the context of LKD follow-up, without placing undue administrative burden on transplant providers. The findings of this RCT will inform potential center- and national-level initiatives to provide all LKDs with small financial incentives to promote engagement with post-donation monitoring efforts.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT03090646 Date of registration: March 2, 2017 Sponsors: Johns Hopkins University, University of Maryland Medical Center Funding: The Living Legacy Foundation of Maryland.",2020,"While donor nephrectomy poses minimal post-surgical risk, LKDs face an elevated adjusted risk of developing chronic diseases such as hypertension, diabetes, and end-stage renal disease.","['Sponsors', 'patients who undergo live donor nephrectomy at The Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) and the University of Maryland Medical Center Transplant Center (MDUM', 'Johns Hopkins University, University of Maryland Medical Center Funding', 'Eligible donors will be recruited in-person at their first post-surgical clinic visit or over the phone']",[],"['complete (all components addressed) and timely (60\u2009days before or after expected visit date), submission of LKD follow-up data at required 6-month, 1-year, and 2-year time points', 'transplant hospital-level compliance with federal reporting requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401187', 'cui_str': 'Live donor nephrectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0376244', 'cui_str': 'funding'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320303', 'cui_str': 'Date of visit'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.171615,"While donor nephrectomy poses minimal post-surgical risk, LKDs face an elevated adjusted risk of developing chronic diseases such as hypertension, diabetes, and end-stage renal disease.","[{'ForeName': 'Macey L', 'Initials': 'ML', 'LastName': 'Levan', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA. macey@jhmi.edu.'}, {'ForeName': 'Madeleine M', 'Initials': 'MM', 'LastName': 'Waldram', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Sandra R', 'Initials': 'SR', 'LastName': 'DiBrito', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Alvin G', 'Initials': 'AG', 'LastName': 'Thomas', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Al Ammary', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Ottman', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Bannon', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Brennan', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Massie', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Scalea', 'Affiliation': 'Division of Transplantation, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rolf N', 'Initials': 'RN', 'LastName': 'Barth', 'Affiliation': 'Division of Transplantation, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dorry L', 'Initials': 'DL', 'LastName': 'Segev', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Garonzik-Wang', 'Affiliation': 'Department of Surgery, Division of Transplantation, Johns Hopkins University School of Medicine, 2000 E. Monument Street, Baltimore, MD, 21205, USA.'}]",BMC nephrology,['10.1186/s12882-020-02117-9']
1692,33167921,"Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial.","BACKGROUND


Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema.
METHODS


Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II).
RESULTS


Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat.
DISCUSSION


It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations.
LIMITATIONS


The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation.
TRIAL REGISTRATION


This trial was registered in ClinicalTrials.gov ( NCT03762044 ). Date of registration: 23 November 2018. Prospectively Registered.",2020,"The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II).
","['individuals with lymphedema in everyday situations', '64 women with breast cancer-related arm lymphedema will take part in the study', 'breast cancer-related arm lymphedema in women', 'patients affected by breast cancer-related arm lymphedema']","['DLT or Complex Physical Therapy (CPT', 'skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II', 'activity-oriented proprioceptive antiedema therapy (TAPA', 'neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging', 'decongestive lymphedema therapy (DLT']","['occupational performance', 'Efficacy and efficiency']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",64.0,0.0364269,"The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II).
","[{'ForeName': 'María Nieves', 'Initials': 'MN', 'LastName': 'Muñoz-Alcaraz', 'Affiliation': 'Córdoba and Guadalquivir health district, Andalusia Health Service, Córdoba, Spain.'}, {'ForeName': 'Luis Ángel', 'Initials': 'LÁ', 'LastName': 'Pérula-de-Torres', 'Affiliation': 'Córdoba and Guadalquivir health district, Andalusia Health Service, Córdoba, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Serrano-Merino', 'Affiliation': 'Córdoba and Guadalquivir health district, Andalusia Health Service, Córdoba, Spain.'}, {'ForeName': 'Antonio José', 'Initials': 'AJ', 'LastName': 'Jiménez-Vílchez', 'Affiliation': 'Valle de los Pedroches Hospital, Pozoblanco, Spain.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Olmo-Carmona', 'Affiliation': 'Reina Sofia Hospital, Córdoba, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Muñoz-García', 'Affiliation': 'Reina Sofia Hospital, Córdoba, Spain.'}, {'ForeName': 'Cruz', 'Initials': 'C', 'LastName': 'Bartolomé-Moreno', 'Affiliation': 'Institute for Health Research Aragon (IIS Aragon), Zaragoza, Spain.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Oliván-Blázquez', 'Affiliation': 'Institute for Health Research Aragon (IIS Aragon), Zaragoza, Spain. bolivan@unizar.es.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Magallón-Botaya', 'Affiliation': 'Institute for Health Research Aragon (IIS Aragon), Zaragoza, Spain.'}]",BMC cancer,['10.1186/s12885-020-07558-x']
1693,33168549,Bathing adaptations in the homes of older adults and their carers (BATH-OUT): a qualitative extended follow-up study with concurrent nested outcome assessments.,"OBJECTIVE


We previously completed a nested qualitative interview study, as part of a feasibility randomised controlled trial with 21 older adults and five carers who had an accessible shower installed in their home. The objective of this study was to follow-up the participants approximately 24 months on.
DESIGN


This was an extended follow-up study comprising semi-structured interviews to explore the longer-term experiences of the older adults. To elaborate and add breadth to the findings these were supplemented with concurrent nested outcome assessment measures.
SETTING


The study was conducted within one local authority City Council housing adaptations service.
PARTICIPANTS


Thirteen older adults (mean age: 76; SD: 6.87) and three carers from the original study completed the extended follow-up study.
INTERVENTIONS


The intervention in the original study was the provision of an accessible showering facility either by immediate provision or routine 4-month wait.
RESULTS


Findings were presented thematically with three themes identified:  environment, autonomy with personal care  and  wider occupation . Improvements in the physical and social environment combined with greater autonomy in personal care were reported to impact more widely on older adults' occupations including other self-care activities and leisure. These are consistent with domains underpinning social care related quality of life particularly personal safety, cleanliness and occupation. The results of the outcome assessments support the qualitative themes demonstrating sustained improvements in quality of life, independence in daily living and reduced fear of falling.
CONCLUSION


This research suggests the positive lived experiences reported immediately after the installation of the accessible shower are still evident up to 28 months later in this cohort of older adults. Future research should investigate medium to longer-term outcomes with a more diverse sample.
TRIAL REGISTRATION


ISRCTN14876332; Post-results.",2020,Improvements in the physical and social environment combined with greater autonomy in personal care were reported to impact more widely on older adults' occupations including other self-care activities and leisure.,"['older adults', 'Thirteen older adults (mean age: 76; SD: 6.87) and three carers from the original study completed the extended follow-up study', '21 older adults and five carers who had an accessible shower installed in their home', 'participants approximately 24 months on']",[],"['quality of life, independence in daily living and reduced fear of falling']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",21.0,0.0392858,Improvements in the physical and social environment combined with greater autonomy in personal care were reported to impact more widely on older adults' occupations including other self-care activities and leisure.,"[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Golding-Day', 'Affiliation': 'Division of Rehabilitation, Ageing & Wellbeing, University of Nottingham, Nottingham, UK miriam.golding-day@nottingham.ac.uk.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Whitehead', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035701']
1694,33168558,Effect of particulate matter exposure on patients with COPD and risk reduction through behavioural interventions: the protocol of a prospective panel study.,"INTRODUCTION


Patients with chronic obstructive pulmonary disease (COPD) are vulnerable to particulate matter (PM) exposure which can increase acute exacerbations and hospitalisation. Interventions to avoid PM exposure are important but evidence-based guidance is lacking. This study aims to assess the impact of PM on lung function, quality of life and exacerbations in patients with COPD using a panel design study; it will also provide evidence for interventional measures to reduce harm from PM exposure.
METHODS AND ANALYSIS


A prospective panel study of patients with COPD aged ≥40 years will be conducted. Patients will be required to have a forced expiratory volume in one second <80% of the predicted value at enrolment. A total of 120 patients from three different regions will be enrolled, 60 from the metropolitan area, 30 from an industrialised area and 30 from a clean rural area. Clinical outcomes will be assessed through COPD assessment test scores, the St. George's Respiratory Questionnaire for patients with COPD and pulmonary function testing. Indoor and outdoor PM in the patients' environments will be measured using gravimetric and light scattering platforms. To estimate the individual dose of PM exposure, a time-activity diary, Geographic Information System and land use regression model will be combined in every season for 1 year. The correlation between PM exposure and the health status of patients with COPD will be evaluated. In addition, 40 patients with the lowest score of life behaviour score to reduce environmental PM exposure will be randomised to a control or intervention group, who will receive in-depth education on risk-reducing behaviours.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Review Board of each site. The participants received comprehensive information and provided informed consent. The result of this study will be discussed in the form of conference presentations and peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT04020237.",2020,"Clinical outcomes will be assessed through COPD assessment test scores, the St. George's Respiratory Questionnaire for patients with COPD and pulmonary function testing.","['40 patients with the lowest score of life behaviour score', 'patients with COPD and risk reduction through behavioural interventions', 'patients with COPD', 'patients with COPD aged ≥40 years', 'Patients with chronic obstructive pulmonary disease (COPD', '120 patients from three different regions will be enrolled, 60 from the metropolitan area, 30 from an industrialised area and 30 from a clean rural area', 'patients with COPD and pulmonary function testing']","['comprehensive information and provided informed consent', 'particulate matter exposure']","[""COPD assessment test scores, the St. George's Respiratory Questionnaire"", 'lung function, quality of life and exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]","[{'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C2960692', 'cui_str': 'Chronic obstructive pulmonary disease assessment test score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",120.0,0.077951,"Clinical outcomes will be assessed through COPD assessment test scores, the St. George's Respiratory Questionnaire for patients with COPD and pulmonary function testing.","[{'ForeName': 'Shinhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Pulmonary, Allergy and Critical Care medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Seung Won', 'Initials': 'SW', 'LastName': 'Ra', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Sung Yoon', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Hwan-Cheol', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational and Environmental Medicine, Inha University College of Medicine, Incheon, Republic of Korea seiwon@amc.seoul.kr carpediem@inha.ac.kr.'}, {'ForeName': 'Sei Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonology and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea seiwon@amc.seoul.kr carpediem@inha.ac.kr.'}]",BMJ open,['10.1136/bmjopen-2020-039394']
1695,33168569,Improving population health in resident clinics: increasing pneumonia vaccination rates in adults 65 years and older.,"Streptococcus pneumoniae  is a significant bacterial pathogen, especially in the elderly. There are two types of pneumococcal vaccines, one with polysaccharides from the capsule of 23 serotypes (PPSV23) and one with polysaccharides from 13 serotypes that have been conjugated to a protein (PCV13). Both vaccines decrease the incidence of invasive pneumococcal disease and are recommended for all people ≥65 years of age. We found the vaccination rate against  S. pneumoniae  in patients ≥65 years of age in our resident physician continuity clinics was 59.85%, which is considerably lower than the vaccination rate of 69.16% in our attending physician clinics. The aim of our study was to double the number of vaccinations given in the resident physician clinics over a 1-month period without compromising workflow or unduly burdening the rooming nurse or resident physicians. For our primary intervention, we assigned a designated nurse with expertise in vaccinations the task of reviewing charts ahead of clinic visits then pending the order for the appropriate pneumococcal vaccine. Our secondary intervention was the education of physicians through pocket cards, verbal encouragement and email reminders. χ² test was conducted to compare the proportion of patients 65 years or older who were vaccinated between the intervention and control groups. The results indicated that the intervention group patients were 2.61 times (95% CI 1.18 to 6.10) more likely to be vaccinated compared with the control group patients (20% vs 8.7%, χ 2  (1)=5.16, p=0.02, Cramer's V=0.16). The intervention resulted in more than doubling the number of vaccinations in the intervention group compared with the control group. Moreover, poststudy interviews and surveys indicated our workflow is sustainable and amendable to wider use within the resident physician clinics.",2020,χ² test was conducted to compare the proportion of patients 65 years or older who were vaccinated between the intervention and control groups.,"['patients 65 years or older who were vaccinated between the intervention and control groups', 'adults 65 years and older', 'patients ≥65 years of age in our resident physician continuity clinics', 'resident physician clinics over a 1-month period without compromising workflow or unduly burdening the rooming nurse or resident physicians']",[],"['incidence of invasive pneumococcal disease', 'number of vaccinations', 'pneumonia vaccination rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.0250651,χ² test was conducted to compare the proportion of patients 65 years or older who were vaccinated between the intervention and control groups.,"[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'McGreevy', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA smcgreevy@kumc.edu.'}, {'ForeName': 'Caylin', 'Initials': 'C', 'LastName': 'McGowan', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Gillenwater', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Opole', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Veluri', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Stehle', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Ramm', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Gibson', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas, USA.'}]",BMJ open quality,['10.1136/bmjoq-2019-000830']
1696,33169699,Immediate effects of a single session of physical exercise on cognition and cerebral blood flow: A randomized controlled study of older adults.,"BACKGROUND


Regular physical activity is beneficial for cognitive performance in older age. A single bout of aerobic physical exercise can transiently improve cognitive performance. Researchers have advanced improvements in cerebral circulation as a mediator of long-term effects of aerobic physical exercise on cognition, but the immediate effects of exercise on cognition and cerebral perfusion are not well characterized and the effects in older adults are largely unknown.
METHODS


Forty-nine older adults were randomized to a 30-min aerobic exercise at moderate intensity or relaxation. Groups were matched on age and cardiovascular fitness (VO2 max). Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads were assessed before and 7 min after exercising/resting.
RESULTS


Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity. GMBF decreased after exercise, relative to the control (resting) group. In the exercise group, higher n-back performance after exercise was associated with lower GMBF in the right hippocampus, left medial frontal cortex and right orbitofrontal cortex, and higher cardiovascular fitness was associated with lower GMBF.
CONCLUSION


The decrease of GMBF reported in younger adults shortly after exercise also occurs in older adults and relates to cardiovascular fitness, potentially supporting the link between cardiovascular fitness and cerebrovascular reactivity in older age.",2020,"RESULTS


Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity.","['older adults', 'Forty-nine older adults', 'older age']","['aerobic physical exercise', 'physical exercise', '30-min aerobic exercise at moderate intensity or relaxation']","['cognitive performance', 'GMBF', 'Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads', 'higher n-back performance', 'cardiovascular fitness', 'cognition and cerebral blood flow']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",49.0,0.0349679,"RESULTS


Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity.","[{'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Olivo', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden. Electronic address: gaia.olivo@ki.se.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Garzón', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wåhlin', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden; Umeå Center for Functional Brain Imaging (UFBI), Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, Stockholm, Sweden; Department of Neuroscience, Karolinska Institute, Stockhom, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117500']
1697,33169704,"Effect of carbon dioxide versus room air insufflation on post-colonoscopic pain: A prospective, randomized, controlled study.","BACKGROUND/AIMS


Room air (RA) and carbon dioxide (CO2) are widely used to insufflate the colon to examine the mucosa in colonoscopy. Pain, discomfort, and bloating can be seen during and after colonoscopy secondary to bowel distention. This study aimed to investigate the effect of CO2 on post-procedure pain sensation (PPPS) in comparison with RA.
MATERIALS AND METHODS


Patients were randomly assigned to the RA and CO2 insufflation groups in a 1:1 ratio. The visual analog scale (VAS) was used to measure the pain before and after the colonoscopy. VAS score of 0 was accepted as the absence of pain and above 0 was accepted as the presence of pain. The primary outcome was to investigate the effect of CO2 insufflation on PPPS. Secondary outcomes were to investigate the other contributing factors affecting PPPS and the effect of CO2 on PPPS in patients with inflammatory bowel disease (IBD).
RESULTS


A total of 204 patients were enrolled in the study. No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy. Furthermore, there was no significant difference in pain sensation between the CO2 and RA groups in patients with IBD. When we investigated the other contributing factors to pain sensation, body-mass index (BMI) was found to be significant at 30 minutes and BMI and colonoscopy time were found to be significant at 6 hours afterwards.
CONCLUSION


We found no favorable effect of CO2 insufflation on PPPS in colonoscopy, including in patients with IBD.",2020,No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy.,"['Patients', '204 patients were enrolled in the study', 'patients with inflammatory bowel disease (IBD', 'post-colonoscopic pain', 'patients with IBD']","['CO2 insufflation', 'CO2', 'carbon dioxide versus room air insufflation', 'RA and CO2 insufflation', 'Room air (RA) and carbon dioxide (CO2']","['pain sensation', 'BMI and colonoscopy time', 'Pain, discomfort, and bloating', 'visual analog scale (VAS', 'VAS score', 'PPPS', 'effect of CO2 insufflation on PPPS', 'pain sensation, body-mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]",204.0,0.0274209,No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy.,"[{'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Gündüz', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey;Marmara University, Institute of Gastroenterology, İstanbul, Turkey.'}, {'ForeName': 'Haluk Tarık', 'Initials': 'HT', 'LastName': 'Kani', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology, Inflammatory Bowel Disease Center, New York University Langone Health, New York, New York.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Akdeniz', 'Affiliation': 'Department of Medical Education, Marmara University, School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Eren', 'Affiliation': 'Marmara University Institute of Gastroenterology, İstanbul, Turkey; Department of Medical Biology, Marmara University School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey;Marmara University, Institute of Gastroenterology, İstanbul, Turkey.'}, {'ForeName': 'Yeşim Özen', 'Initials': 'YÖ', 'LastName': 'Alahdab', 'Affiliation': 'Department of Gastroenterology, Marmara University School of Medicine, İstanbul, Turkey;Marmara University, Institute of Gastroenterology, İstanbul, Turkey.'}]",The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology,['10.5152/tjg.2020.20596']
1698,31754133,Genome Wide Analysis Approach Suggests Chromosome 2 Locus to be Associated with Thiazide and Thiazide Like-Diuretics Blood Pressure Response.,"Chlorthalidone (CTD) is more potent than hydrochlorothiazide (HCTZ) in reducing blood pressure (BP) in hypertensive patients, though both are plagued with BP response variability. However, there is a void in the literature regarding the genetic determinants contributing to the variability observed in BP response to CTD. We performed a discovery genome wide association analysis of BP response post CTD treatment in African Americans (AA) and European Americans (EA) from the Pharmacogenomic Evaluation of Antihypertensive Responses-2 (PEAR-2) study and replication in an independent cohort of AA and EA treated with HCTZ from the PEAR study, followed by a race specific meta-analysis of the two studies. Successfully replicated SNPs were further validated in beta-blocker treated participants from PEAR-2 and PEAR for opposite direction of association. The replicated and validated signals were further evaluated by protein-protein interaction network analysis. An intronic SNP rs79237970 in the WDR92 (eQTL for PPP3R1) was significantly associated with better DBP response to CTD (p = 5.76 × 10 -6 , β = -15.75) in the AA cohort. This SNP further replicated in PEAR (p = 0.00046, β = -9.815) with a genome wide significant meta-analysis p-value of 8.49 × 10 -9 . This variant was further validated for opposite association in two β-blockers treated cohorts from PEAR-2 metoprolol (p = 9.9 × 10 -3 , β = 7.47) and PEAR atenolol (p = 0.04, β = 4.36) for association with DBP. Studies have implicated WDR92 in coronary artery damage. PPP3R1 is the regulatory subunit of the calcineurin complex. Use of calcineurin inhibitors is associated with HTN. Studies have also shown polymorphisms in PPP3R1 to be associated with ventricular hypertrophy in AA hypertensive patients. Protein-protein interaction analysis further identified important hypertension related pathways such as inositol phosphate-mediated signaling and calcineurin-NFAT signaling cascade as important biological process associated with PPP3R1 which further strengthen the potential importance of this signal. These data collectively suggest that WDR92 and PPP3R1 are novel candidates that may help explain the genetic underpinnings of BP response of thiazide and thiazide-like diuretics and help identify the patients better suited for thiazide and thiazide-like diuretics compared to β-blockers for improved BP management. This may further help advance personalized approaches to antihypertensive therapy.",2019,"Chlorthalidone (CTD) is more potent than hydrochlorothiazide (HCTZ) in reducing blood pressure (BP) in hypertensive patients, though both are plagued with BP response variability.","['AA hypertensive patients', 'African Americans (AA) and European Americans (EA', 'hypertensive patients']","['Chlorthalidone (CTD', 'Thiazide and Thiazide', 'PEAR-2 metoprolol', 'PEAR atenolol', 'calcineurin inhibitors', 'HCTZ', 'hydrochlorothiazide (HCTZ']","['blood pressure (BP', 'DBP response to CTD']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0239307', 'cui_str': 'European'}]","[{'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0330664', 'cui_str': 'Pyrus communis'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}]",,0.0197267,"Chlorthalidone (CTD) is more potent than hydrochlorothiazide (HCTZ) in reducing blood pressure (BP) in hypertensive patients, though both are plagued with BP response variability.","[{'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Caitrin W', 'Initials': 'CW', 'LastName': 'McDonough', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Kent R', 'Initials': 'KR', 'LastName': 'Bailey', 'Affiliation': 'Division of Biostatistics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boerwinkle', 'Affiliation': 'Human Genetics and Institute of Molecular Medicine, University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'Division of Nephrology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gums', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Turner', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA. julie.johnson@ufl.edu.'}]",Scientific reports,['10.1038/s41598-019-53345-5']
1699,33185339,[The efficiency of combination therapy of non-gonococcal urethritis in men].,"AIM


To carry out a comparative assessment of the efficiency of combination therapy for non-gonococcal urethritis (NGU) in men.
MATERIALS AND METHODS


a total of 124 patients with NGU and laboratory-confirmed urogenital infection were included in the study. The diagnostic methods included microscopy of urethral smear, real-time polymerase chain reaction (PCR) for the detection of uropathogens and laser Doppler flowmetry for evaluating the urethral microcirculation. All patients were randomized into three groups matched for age, clinical manifestations, and disease duration. Patients of the group 1 received targeted antibiotic therapy. In the group 2, local peloid therapy was added, while patients in group 3 additionally received vibromagnetotherapy. The control group consisted of 22 patients aged 18 to 55 years. The study included 2 visits, at the baseline and 4 weeks after the end of treatment.
RESULTS


After the treatment, the frequency of microbiological cure was 89%. In the group 3, more pronounced improvement in main symptoms of NGU was observed. The analysis of microcirculation after treatment in the groups 2 and 3 showed a significant increase in perfusion and modulation of urethral blood flow and a decrease in venous congestion after combined therapy.
CONCLUSION


The combined treatment, including antibiotic, peloid therapy, and vibromagnetotherapy, promotes more pronounced clinical improvement, restoration of urethral microcirculation and relief of inflammatory process in patients with NGU and can be recommended for routine clinical practice.",2020,"The analysis of microcirculation after treatment in the groups 2 and 3 showed a significant increase in perfusion and modulation of urethral blood flow and a decrease in venous congestion after combined therapy.
","['non-gonococcal urethritis in men', '22 patients aged 18 to 55 years', 'non-gonococcal urethritis (NGU) in men', 'patients with NGU and can be recommended for routine clinical practice', 'a total of 124 patients with NGU and laboratory-confirmed urogenital infection were included in the study']","['vibromagnetotherapy', 'targeted antibiotic therapy', 'local peloid therapy']","['main symptoms of NGU', 'microscopy of urethral smear, real-time polymerase chain reaction (PCR', 'frequency of microbiological cure', 'urethral microcirculation and relief of inflammatory process', 'perfusion and modulation of urethral blood flow', 'venous congestion']","[{'cui': 'C1112709', 'cui_str': 'Nongonococcal urethritis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0026729', 'cui_str': 'Therapy, Mud'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1112709', 'cui_str': 'Nongonococcal urethritis'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0042484', 'cui_str': 'Passive congestion'}]",124.0,0.036866,"The analysis of microcirculation after treatment in the groups 2 and 3 showed a significant increase in perfusion and modulation of urethral blood flow and a decrease in venous congestion after combined therapy.
","[{'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Kovalyeva', 'Affiliation': 'Department of Dermatology and Venerology, Cosmetology and Immunology of Altai State Medical University of the Ministry of Health of Russia, Barnaul, Russia.'}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Neymark', 'Affiliation': 'Department of Dermatology and Venerology, Cosmetology and Immunology of Altai State Medical University of the Ministry of Health of Russia, Barnaul, Russia.'}, {'ForeName': 'Ya D', 'Initials': 'YD', 'LastName': 'Zheltikova', 'Affiliation': 'Department of Dermatology and Venerology, Cosmetology and Immunology of Altai State Medical University of the Ministry of Health of Russia, Barnaul, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Subbotin', 'Affiliation': 'Department of Dermatology and Venerology, Cosmetology and Immunology of Altai State Medical University of the Ministry of Health of Russia, Barnaul, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1700,33185345,[Pharmacokinetic features of sildenafil spray in healthy men depending on food intake].,"AIM


In order to evaluate the bioequivalence and benefits of a new dosage form of the type 5 phosphodiesterase inhibitor, sildenafil, two open-label studies in healthy male volunteers were carried out.
MATERIALS AND METHODS


An open, randomized, crossover study to compare the pharmacokinetics after a single dose of sildenafil at a dosage of 50 mg on an empty stomach in a new spray form (test drug) and in a traditional tablet form (comparison drug) on 44 volunteers (18 to 43 years old) was done. To assess the effect of food intake on pharmacokinetics, an open, non-randomized study was conducted on 6 healthy male volunteers (from 23 to 35 years old) who received sildenafil (50 mg) after a meal in timely fashion: 1) spray, under the tongue, without drinking, 2) spray , in the mouth, drinking water and 3) the tablet form, drinking water. For pharmacokinetic analysis, blood was analyzed for 24 hours. Plasma concentration of sildenafil was determined by high performance liquid chromatography with tandem mass spectrometric detection (HPLC/TM/SD). The main parameters were the rate (maximum concentration; Cmax) and the degree of absorption (area under the pharmacokinetic curve ""concentration-time"" during the observation period; AUC0-t) after a single dose of drugs. In addition, the pharmacokinetic profiles of the bioavailability of sildenafil and its active metabolite, N-desmethyl sildenafil, as well as the safety of the different dosage forms, were evaluated.
RESULTS


When comparing taking drugs on an empty stomach, the 90% confidence intervals (CI) of the ratios of the mean Cmax and AUC0-t values of sildenafil were 82-106% and 82-101%, respectively. An earlier achievement of the maximum concentration of sildenafil was detected when taking the test drug compared with the standard form (51 and 62 minutes, respectively, Z-value=-2.25, p-value=0.0244). In addition, it was shown that when taking Viagra after a meal, the determination of sildenafil in plasma was delayed (after 30 minutes) compared to the tested drugs (after 10 minutes), however, significant differences in Tmax between the dosage forms were not seen. In two studies, most adverse events were mild to moderate and resolved uneventfully.
DISCUSSION


The bioavailability of the new dosage form, the sildenafil spray, is equivalent to the traditional form, however, it has an advantage in terms of onset of action. For example, when taking a spray, an earlier achievement of the maximum concentration of sildenafil and an earlier detection of sildenafil in plasma are shown compared to the traditional tablet form.
CONCLUSIONS


Our results suggest that the new dosage form of sildenafil is a reliable alternative therapeutic option for the treatment of erectile dysfunction.",2020,"An earlier achievement of the maximum concentration of sildenafil was detected when taking the test drug compared with the standard form (51 and 62 minutes, respectively, Z-value=-2.25, p-value=0.0244).","['healthy male volunteers', '6 healthy male volunteers (from 23 to 35 years old) who received', 'healthy men depending on food intake', '44 volunteers (18 to 43 years old']","['phosphodiesterase inhibitor, sildenafil', 'sildenafil spray', 'sildenafil', 'sildenafil (50 mg) after a meal in timely fashion: 1) spray, under the tongue, without drinking, 2) spray , in the mouth, drinking water and 3) the tablet form, drinking water']","['rate (maximum concentration; Cmax) and the degree of absorption (area under the pharmacokinetic curve ""concentration-time', 'maximum concentration of sildenafil', 'Plasma concentration of sildenafil', 'Tmax', 'mean Cmax and AUC0-t values of sildenafil']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]","[{'cui': 'C0031638', 'cui_str': 'Phosphodiesterase inhibitor'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",6.0,0.0437994,"An earlier achievement of the maximum concentration of sildenafil was detected when taking the test drug compared with the standard form (51 and 62 minutes, respectively, Z-value=-2.25, p-value=0.0244).","[{'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Krivoborodov', 'Affiliation': 'Department of Urology and Andrology of N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow, Russia.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Zakharov', 'Affiliation': 'Department of Urology and Andrology of N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow, Russia.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Vasilyuk', 'Affiliation': 'Department of Urology and Andrology of N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow, Russia.'}, {'ForeName': 'G G', 'Initials': 'GG', 'LastName': 'Rodionov', 'Affiliation': 'Department of Urology and Andrology of N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Vetrova', 'Affiliation': 'Department of Urology and Andrology of N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1701,33185618,Escitalopram improves neural functional prognosis and endothelial dysfunction in patients with acute cerebral infarction.,"BACKGROUND


Escitalopram is one of the most commonly used SSRIs at present, which has the characteristics of quick onset, less interactions with other drugs, and relative safety.
OBJECTIVE


This study aims to investigate the effects of escitalopram on neural functional prognoses and endothelial dysfunction after acute ischemic stroke.
METHODS


One hundred eligible patients afflicted with acute ischemic stroke were randomized into two groups: control and treatment groups. Patients in the treatment group received escitalopram in addition to the basic therapies in the control group over a period of 90 days. Neurological deficits were quantified using the National Institutes of Health Stroke Scale (NIHSS) score and Barthel index (BI) score, cognitive impairment was determined using the Mini-Mental State Examination (MMSE) score, depressive symptoms were measured using the 17-item Hamilton Depression Rating Scale (HAMD). Furthermore, post-stroke depression (PSD) was defined based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), with a HAMD score ≥17. Flow-mediated vascular dilatation (FMD) of the brachial artery was use as a surrogate indicator for endothelial dysfunction assessment with ultrasound.
RESULTS


The mean NIHSS and HAMD scores on day 90 after treatment were significantly lower in the treatment group than in the control group (2.17±0.36 vs. 4.24±0.85; 5.81±1.35 vs. 10.43±4.91; P < 0.01), while the mean BI score and FMD were significantly higher in the treatment group (93.08±6.23 vs. 79.64±7.56, P < 0.01; 8.71±2.35 vs. 5.83±1.21, P < 0.05) than in the control group. The improvement in MMSE score was not significantly different between the two groups.
CONCLUSIONS


Treatment with escitalopram early after ischemic stroke can improve neural functional prognoses and endothelial dysfunction. Escitalopram had less side effects, which is worthy of clinical prophylactic application.",2020,"The mean NIHSS and HAMD scores on day 90 after treatment were significantly lower in the treatment group than in the control group (2.17±0.36 vs. 4.24±0.85; 5.81±1.35 vs. 10.43±4.91; P < 0.01), while the mean BI score and FMD were significantly higher in the treatment group (","['patients with acute cerebral infarction', 'One hundred eligible patients afflicted with acute ischemic stroke']","['escitalopram', 'Escitalopram']","['mean BI score and FMD', 'Mini-Mental State Examination (MMSE) score, depressive symptoms', '17-item Hamilton Depression Rating Scale (HAMD', 'National Institutes of Health Stroke Scale (NIHSS) score and Barthel index (BI) score, cognitive impairment', 'neural functional prognoses and endothelial dysfunction', 'MMSE score', 'side effects', 'neural functional prognosis and endothelial dysfunction', 'mean NIHSS and HAMD scores', 'Flow-mediated vascular dilatation (FMD', 'Neurological deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}]",100.0,0.0458939,"The mean NIHSS and HAMD scores on day 90 after treatment were significantly lower in the treatment group than in the control group (2.17±0.36 vs. 4.24±0.85; 5.81±1.35 vs. 10.43±4.91; P < 0.01), while the mean BI score and FMD were significantly higher in the treatment group (","[{'ForeName': 'Jin-Xia', 'Initials': 'JX', 'LastName': 'Cao', 'Affiliation': ""Department of Neuropsychiatry, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neuropsychiatry, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Yun-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Neuropsychiatry, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Qing-Hong', 'Initials': 'QH', 'LastName': 'Zeng', 'Affiliation': ""Department of Neurology, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasonography, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Jie-Chun', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, The Lianyungang Second People's Hospital, Jiangsu, China.""}]",Restorative neurology and neuroscience,['10.3233/RNN-201041']
1702,33170239,"Effect of Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program on Clinical Outcomes in Older Adults: The DO-HEALTH Randomized Clinical Trial.","Importance


The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear.
Objective


To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults.
Design, Setting, and Participants


Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017.
Interventions


Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270).
Main Outcomes and Measures


The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance.
Results


Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups.
Conclusions and Relevance


Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01745263.",2020,"Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years.","['older adults', 'adults without major comorbidities aged 70 years or older, treatment with', 'Older Adults', 'Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017', '2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status', '2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study']","['vitamin D, omega-3s, and a strength-training exercise program, alone or in combination', 'vitamin D3 and omega-3s (n\u2009=\u2009265); vitamin D3 and exercise (n\u2009=\u2009275); vitamin D3 alone (n\u2009=\u2009272); omega-3s and exercise (n\u2009=\u2009275); omega-3s alone (n\u2009=\u2009269); exercise alone', 'vitamin D3', 'placebo', 'vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program', 'vitamin D, omega-3 fatty acids, and exercise', 'Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program']","['mean change in diastolic BP', 'change in systolic and diastolic blood pressure (BP', 'mean change in IR of infections', 'SPPB, MoCA, and incidence of nonvertebral fractures', 'Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years', 'systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",2157.0,0.171665,"Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years.","[{'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rizzoli', 'Affiliation': 'Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Reto W', 'Initials': 'RW', 'LastName': 'Kressig', 'Affiliation': 'University Department of Geriatric Medicine Felix Platter and University of Basel, Basel, Switzerland.'}, {'ForeName': 'José A P', 'Initials': 'JAP', 'LastName': 'da Silva', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blauth', 'Affiliation': 'Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'NIHR Manchester Biomedical Research Center, Manchester University NHS Foundation Trust, Manchester Academic Health Science Center, Manchester, England.'}, {'ForeName': 'Eugene V', 'Initials': 'EV', 'LastName': 'McCloskey', 'Affiliation': 'MRC Arthritis Research UK Center for Integrated Research Into Musculoskeletal Ageing, University of Sheffield, Sheffield, England.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Watzl', 'Affiliation': 'Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany.'}, {'ForeName': 'Lorenz C', 'Initials': 'LC', 'LastName': 'Hofbauer', 'Affiliation': 'Center for Healthy Aging, Department of Medicine III Dresden University Medical Center, Dresden, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Siebert', 'Affiliation': 'Department of Public Health, Health Services Research, and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics, and Technology, Hall in Tirol, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hannes B', 'Initials': 'HB', 'LastName': 'Staehelin', 'Affiliation': 'Department of Geriatrics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patricia O', 'Initials': 'PO', 'LastName': 'Chocano-Bedoya', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Abderhalden', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Center for Metabolic Diseases, University of Sheffield Medical School, Sheffield, England.'}, {'ForeName': 'Endel J', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16909']
1703,33170240,Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial.,"Importance


Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial.
Objective


To evaluate e-cigarettes with individual counseling for smoking cessation.
Design, Setting, and Participants


A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported.
Interventions


Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling.
Main Outcomes and Measures


The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence.
Results


Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).
Conclusions and Relevance


Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT02417467.",2020,"Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]).","['adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined', 'Smoking Cessation', '376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively']","['nicotine e-cigarettes (n\u2009=\u2009128), nonnicotine e-cigarettes (n\u2009=\u2009127), or no e-cigarettes', 'e-Cigarettes Plus Counseling vs Counseling Alone', 'individual counseling', 'nonnicotine e-cigarette with counseling']","['point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide', 'Adverse events', 'Point prevalence abstinence', 'point prevalence abstinence', 'prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}]",376.0,0.135469,"Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]).","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Eisenberg', 'Affiliation': 'Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.'}, {'ForeName': 'Andréa', 'Initials': 'A', 'LastName': 'Hébert-Losier', 'Affiliation': 'Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Windle', 'Affiliation': 'Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Greenspoon', 'Affiliation': 'Hamilton Community Health Centre, Family Health Organization, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brandys', 'Affiliation': 'Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tamàs', 'Initials': 'T', 'LastName': 'Fülöp', 'Affiliation': 'Centre de recherche sur le vieillissement, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Thang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'St Boniface Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Elkouri', 'Affiliation': ""Division of Vascular Surgery, Centre hospitalier de l'Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Montigny', 'Affiliation': 'Centre intégré de santé et de services sociaux de Laval, Hôpital Cité-de-la-Santé, Laval, Québec, Canada.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Wilderman', 'Affiliation': 'Wilderman Medical Clinic/Canadian Centre for Clinical Trials, Thornhill, Ontario, Canada.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Institut de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec City, Québec, Canada.'}, {'ForeName': 'Joanna Alexis', 'Initials': 'JA', 'LastName': 'Bostwick', 'Affiliation': 'Hôpital Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Abrahamson', 'Affiliation': 'Michael Garron Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lacasse', 'Affiliation': 'Institut de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec City, Québec, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Pakhale', 'Affiliation': 'The Ottawa Hospital Research Institute/The Bridge Engagement Centre, Ottawa, Ontario, Canada.'}, {'ForeName': 'Josselin', 'Initials': 'J', 'LastName': 'Cabaussel', 'Affiliation': 'Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.'}, {'ForeName': 'Kristian B', 'Initials': 'KB', 'LastName': 'Filion', 'Affiliation': 'Lady Davis Institute, Jewish General Hospital, Montréal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.18889']
1704,33172456,Effects of Er:YAG laser pre-treatment on dentin structure and bonding strength of primary teeth: an in vitro study.,"BACKGROUND


To investigate the effects of Er:YAG laser pre-treatment on the dentin structure and shear bond strength of primary teeth.
METHODS


Dentin specimens were prepared using freshly extracted intact primary molars and divided randomly into four groups based on the surface treatment applied. The control and etchant groups received no treatment and conventional acid etching treatment, respectively, while the energy and frequency groups received laser surface treatment with variable energy (50-300 mJ) and frequency (5-30 Hz) parameters. The morphology was observed using scanning electron microscopy. The surface-treated dentin slices were bonded to resin tablets, followed by thermocycle treatment. The shear strength was determined using a universal testing machine and de-bonded surfaces were observed using a stereomicroscope.
RESULTS


SEM observation showed that the surface morphology of the dentin slices changed after etching as well as after Er:YAG laser pre-treatment with different energy and frequency values. The dentin tubules opened within a specific energy (50-200 mJ) and frequency (5-20 Hz) range. Beyond this range, the intertubular dentin showed cracks and structural disintegration. Shear strength tests showed no significant changes after acid etching. The shear strength increased significantly (P < 0.05) after Er:YAG laser pre-treatment compared with that of the control group. The shear strength increased within the same energy (50-200 mJ) and frequency (5-20 Hz) range as the tubule opening, but not significantly (P > 0.05). The most common mode of interface failure was adhesive (interface) failure, followed by mixed and resin cohesive failure.
CONCLUSIONS


Pre-treatment using Er:YAG laser opens the dentinal tubules without the formation of a smear layer and improves the bonding strength between the primary teeth dentin and the resin composites.",2020,The shear strength increased significantly (P < 0.05) after Er:YAG laser pre-treatment compared with that of the control group.,"['Dentin specimens were prepared using freshly extracted intact primary molars', 'primary teeth']","['no treatment and conventional acid etching treatment, respectively, while the energy and frequency groups received laser surface treatment with variable energy', 'Er:YAG laser pre-treatment', 'Er:YAG laser']","['dentin structure and bonding strength', 'bonding strength', 'surface morphology of the dentin slices', 'Shear strength tests', 'shear strength']","[{'cui': 'C1292488', 'cui_str': 'Dentin specimen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C1135950', 'cui_str': 'Shear Strength'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0185311,The shear strength increased significantly (P < 0.05) after Er:YAG laser pre-treatment compared with that of the control group.,"[{'ForeName': 'Jun Hui', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Military Stomatology and National Clinical Research Center for Oral Disease and Shaanxi Clinical Research Center for Oral Diseases, Stomatology Department of Children, School of Stomatology, The Fourth Military Medical University, No. 145, Changle West Road, Xincheng District, Xi'an, Shaanxi, China.""}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': ""Department of Orthodontics, College of Stomatology, Xi'an Jiaotong University, No. 98, Xiwu Road, Xincheng District, Xi'an, Shaanxi, China.""}, {'ForeName': 'Bai Ze', 'Initials': 'BZ', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Military Stomatology and National Clinical Research Center for Oral Disease and Shaanxi Clinical Research Center for Oral Diseases, Stomatology Department of Children, School of Stomatology, The Fourth Military Medical University, No. 145, Changle West Road, Xincheng District, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhi Fei', 'Initials': 'ZF', 'LastName': 'Zhou', 'Affiliation': ""Department of Stomatology, General Hospital of Tibet Military Region, Chinese People's Liberation Army, Lhasa, Tibet, China.""}, {'ForeName': 'Zi Rui', 'Initials': 'ZR', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Military Stomatology and National Clinical Research Center for Oral Disease and Shaanxi Clinical Research Center for Oral Diseases, Stomatology Department of Children, School of Stomatology, The Fourth Military Medical University, No. 145, Changle West Road, Xincheng District, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ge', 'Affiliation': ""State Key Laboratory of Military Stomatology and National Clinical Research Center for Oral Disease and Shaanxi Clinical Research Center for Oral Diseases, Stomatology Department of Children, School of Stomatology, The Fourth Military Medical University, No. 145, Changle West Road, Xincheng District, Xi'an, Shaanxi, China.""}, {'ForeName': 'Lu Lu', 'Initials': 'LL', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yu Jiang', 'Initials': 'YJ', 'LastName': 'Chen', 'Affiliation': ""State Key Laboratory of Military Stomatology and National Clinical Research Center for Oral Disease and Shaanxi Clinical Research Center for Oral Diseases, Stomatology Department of Children, School of Stomatology, The Fourth Military Medical University, No. 145, Changle West Road, Xincheng District, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiao Jing', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Military Stomatology and National Clinical Research Center for Oral Disease and Shaanxi Clinical Research Center for Oral Diseases, Stomatology Department of Children, School of Stomatology, The Fourth Military Medical University, No. 145, Changle West Road, Xincheng District, Xi'an, Shaanxi, China. wxjing@fmmu.edu.cn.""}]",BMC oral health,['10.1186/s12903-020-01315-z']
1705,33172547,[Risk factors for hypoglycemia in preterm infants with a gestational age of ≤32 weeks].,"OBJECTIVE


To investigate the risk factors for hypoglycemia after birth in preterm infants with a gestational age of ≤32 weeks.
METHODS


A retrospective analysis was performed for 86 neonates with hypoglycemia and a gestational age of ≤32 weeks who were admitted to the neonatal intensive care unit from January 2017 to June 2020 (hypoglycemia group). A total of 172 preterm infants with normal blood glucose who were hospitalized during the same period were randomly enrolled as the control group. Univariate analysis and multivariate logistic regression analysis were used to screen out the risk factors for hypoglycemia in preterm infants.
RESULTS


There were 515 preterm infants during the study, among whom 86 (16.7%) had hypoglycemia. Compared with the control group, the hypoglycemia group had significantly higher percentages of small for gestational age (SGA), cesarean section, maternal hypertension, and antenatal steroid administration (P<0.05), but significantly lower birth weight and rate of intravenous glucose use before blood glucose test (P<0.05). SGA (OR=4.311, 95%CI: 1.285-14.462, P<0.05), maternal hypertension (OR=2.469, 95%CI: 1.310-4.652, P<0.05), and antenatal steroid administration (OR=6.337, 95%CI: 1.430-28.095, P<0.05) were risk factors for hypoglycemia in preterm infants, while intravenous glucose use (OR=0.318, 95%CI: 0.171-0.591, P<0.05) was a protective factor against hypoglycemia in preterm infants.
CONCLUSIONS


SGA, maternal hypertension, and antenatal steroid administration may increase the risk of early hypoglycemia in preterm infants with a gestational age of ≤32 weeks, and intravenous glucose use is recommended as soon as possible after birth for preterm infants with a gestational age of ≤32 weeks to reduce the incidence rate of hypoglycemia.",2020,"SGA (OR=4.311, 95%CI: 1.285-14.462, P<0.05), maternal hypertension (OR=2.469, 95%CI: 1.310-4.652, P<0.05), and antenatal steroid administration (OR=6.337, 95%CI: 1.430-28.095, P<0.05) were risk factors for hypoglycemia in preterm infants, while intravenous glucose use (OR=0.318, 95%CI: 0.171-0.591, P<0.05) was a protective factor against hypoglycemia in preterm infants.
","['preterm infants', '86 neonates with hypoglycemia and a gestational age of ≤32 weeks who were admitted to the neonatal intensive care unit from January 2017 to June 2020 (hypoglycemia group', 'preterm infants with a gestational age of ≤32 weeks', '515 preterm infants during the study, among whom 86 (16.7%) had hypoglycemia', '172 preterm infants with normal blood glucose who were hospitalized during the same period were randomly enrolled as the control group']",[],"['risk factors for hypoglycemia', 'birth weight and rate of intravenous glucose use before blood glucose test', 'maternal hypertension', 'protective factor against hypoglycemia', 'risk of early hypoglycemia', 'SGA', 'small for gestational age (SGA), cesarean section, maternal hypertension, and antenatal steroid administration']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",172.0,0.0331462,"SGA (OR=4.311, 95%CI: 1.285-14.462, P<0.05), maternal hypertension (OR=2.469, 95%CI: 1.310-4.652, P<0.05), and antenatal steroid administration (OR=6.337, 95%CI: 1.430-28.095, P<0.05) were risk factors for hypoglycemia in preterm infants, while intravenous glucose use (OR=0.318, 95%CI: 0.171-0.591, P<0.05) was a protective factor against hypoglycemia in preterm infants.
","[{'ForeName': 'Zhi-Xuan', 'Initials': 'ZX', 'LastName': 'Yuan', 'Affiliation': 'Department of Neonatology, First Affiliated Hospital of Anhui Medical University, Hefei 230000, China. 972946475@qq.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Can-Can', 'Initials': 'CC', 'LastName': 'Duan', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Wang', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
1706,33172550,[Pharmacokinetics and pharmacodynamics of pegylated recombinant human granulocyte colony-stimulating factor in children with acute lymphoblastic leukemia: a prospective control trial].,"OBJECTIVE


To study the pharmacokinetic characteristics, clinical effect, and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in children with acute lymphoblastic leukemia (ALL).
METHODS


A prospective study was performed on children with ALL who cyclophosphamide, cytarabine, and 6-mercaptopurine were used for consolidation therapy. PEG-rhG-CSF (PEG-rhG-CSF group) or rhG-CSF (rhG-CSF group) was injected after chemotherapy. The plasma concentration of PEG-rhG-CSF was measured, and clinical outcome and safety were observed for both groups.
RESULTS


A total of 17 children with ALL were enrolled, with 9 children in the PEG-rhG-CSF group and 8 children in the rhG-CSF group. In the PEG-rhG-CSF group, the peak concentration of PEG-rhG-CSF was 348.2 ng/mL (range 114.7-552.0 ng/mL), the time to peak was 48 hours (range 12-72 hours), and the half life was 14.1 hours (range 11.1-18.1 hours). The plasma concentration curve of PEG-rhG-CSF was consistent with the mechanism of neutrophil-mediated clearance. Compared with the rhG-CSF group, the PEG-rhG-CSF group had a significantly shorter median time to absolute neutrophil count (ANC) recovery (P<0.05). There were no significant differences between the two groups in ANC nadir, incidence rate of febrile neutropenia, duration of grade IV neutropenia, incidence rate of infection, and length of hospital stay. No bone pain or muscle soreness was observed in either group (P>0.05).
CONCLUSIONS


The pharmacokinetic characteristics of PEG-rhG-CSF in children with ALL receiving consolidation chemotherapy are consistent with the mechanism of neutrophil-mediated clearance, with a short half life and fast recovery of ANC, and there are no significant differences in safety between PEG-rhG-CSF and rhG-CSF.",2020,"There were no significant differences between the two groups in ANC nadir, incidence rate of febrile neutropenia, duration of grade IV neutropenia, incidence rate of infection, and length of hospital stay.","['children with acute lymphoblastic leukemia (ALL', '17 children with ALL were enrolled, with 9 children in the PEG-rhG-CSF group and 8 children in the rhG-CSF group', 'children with ALL receiving consolidation chemotherapy', 'children with acute lymphoblastic leukemia', 'children with ALL who']","['pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF', 'cyclophosphamide, cytarabine, and 6-mercaptopurine', 'pegylated recombinant human granulocyte colony-stimulating factor', 'PEG-rhG-CSF (PEG-rhG-CSF group) or rhG-CSF']","['ANC nadir, incidence rate of febrile neutropenia, duration of grade IV neutropenia, incidence rate of infection, and length of hospital stay', 'plasma concentration of PEG-rhG-CSF', 'peak concentration of PEG-rhG-CSF', 'median time to absolute neutrophil count (ANC) recovery', 'plasma concentration curve of PEG-rhG-CSF', 'bone pain or muscle soreness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}]","[{'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3852764', 'cui_str': 'PEG-rhG-CSF'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",17.0,0.0185871,"There were no significant differences between the two groups in ANC nadir, incidence rate of febrile neutropenia, duration of grade IV neutropenia, incidence rate of infection, and length of hospital stay.","[{'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China. xfzhu1981@126.com.'}, {'ForeName': 'Tian-Feng', 'Initials': 'TF', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiao-Juan', 'Initials': 'XJ', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ben-Quan', 'Initials': 'BQ', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Li-Xian', 'Initials': 'LX', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ruan', 'Affiliation': ''}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Xiao-Fan', 'Initials': 'XF', 'LastName': 'Zhu', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
1707,33172557,[Nutritional support in children with pneumonia on mechanical ventilation by short-peptide enteral nutrition formula].,"OBJECTIVE


To observe the incidence of malnutrition and nutritional risk in children with pneumonia on mechanical ventilation in the pediatric intensive care unit (PICU), and to explore the nutritional support effect of short-peptide enteral nutrition formula.
METHODS


A total of 68 children with severe pneumonia who were hospitalized in the PICU from October 2017 to October 2018 and required mechanical ventilation were enrolled for a prospective randomized controlled study. The children were randomly divided into a control group and an experimental group. Through the nasogastric feeding tube, the experimental group received the short-peptide enteral nutrition formula, and the control group received the intact-protein enteral nutrition formula. The weight-for-age Z score, STRONGkids nutritional risk score, and pediatric critical illness score of the two groups were evaluated. The serum levels of total protein, albumin, and prealbumin (PA) on admission and before discharge were measured. The gastrointestinal tolerance and clinical outcome indicators of the two groups were observed.
RESULTS


Among the 68 mechanically ventilated children, 26 (38%) had malnutrition, including moderate malnutrition (10 cases, 15%) and severe malnutrition (16 cases, 24%); 10 cases (15%) had malnutrition at discharge. Sixty-three children (93%) had nutritional risk, including moderate nutritional risk in 21 cases and high nutritional risk in 42 cases. The moderate and high nutritional risk rates of the critical and extreme critical groups were significantly higher than those of the non-critical group (P<0.05). Compared with the control group, the experimental group had significantly shorter duration of mechanical ventilation and total length of hospital stay, significantly higher serum PA level and weight growth rate, and significantly better gastrointestinal tolerance (P<0.05). There were no significant differences in the incidence of ventilator-associated pneumonia and disease outcome between the two groups (P>0.05).
CONCLUSIONS


The detection rates of malnutrition and nutritional risk in children with pneumonia on mechanical ventilation are relatively high. Short-peptide enteral nutrition formula can help improve their treatment outcome and are more suitable for nutritional support in critically ill children on mechanical ventilation.",2020,"Compared with the control group, the experimental group had significantly shorter duration of mechanical ventilation and total length of hospital stay, significantly higher serum PA level and weight growth rate, and significantly better gastrointestinal tolerance (P<0.05).","['children with pneumonia on mechanical ventilation by short-peptide enteral nutrition formula', '68 mechanically ventilated children', 'children with pneumonia on mechanical ventilation in the pediatric intensive care unit (PICU', 'children with pneumonia on mechanical ventilation', 'critically ill children on mechanical ventilation', 'Sixty-three children (93%) had nutritional risk, including moderate nutritional risk in 21 cases and high nutritional risk in 42 cases', '68 children with severe pneumonia who were hospitalized in the PICU from October 2017 to October 2018 and required mechanical ventilation']",['intact-protein enteral nutrition formula'],"['moderate and high nutritional risk rates', 'gastrointestinal tolerance', 'serum levels of total protein, albumin, and prealbumin (PA) on admission and before discharge', 'malnutrition, including moderate malnutrition', 'weight-for-age Z score, STRONGkids nutritional risk score, and pediatric critical illness score', 'incidence of ventilator-associated pneumonia and disease outcome', 'serum PA level and weight growth rate, and significantly better gastrointestinal tolerance', 'shorter duration of mechanical ventilation and total length of hospital stay', 'severe malnutrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1273508', 'cui_str': 'Serum prealbumin level'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0311276', 'cui_str': 'Severe malnutrition'}]",68.0,0.0210033,"Compared with the control group, the experimental group had significantly shorter duration of mechanical ventilation and total length of hospital stay, significantly higher serum PA level and weight growth rate, and significantly better gastrointestinal tolerance (P<0.05).","[{'ForeName': 'Xian-Jie', 'Initials': 'XJ', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatric Intensive Care Unit, Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China. junying.qiao@163.com.'}, {'ForeName': 'Fei-Fei', 'Initials': 'FF', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jian-Chuang', 'Initials': 'JC', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Ya-Zhen', 'Initials': 'YZ', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jun-Ying', 'Initials': 'JY', 'LastName': 'Qiao', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
1708,33172941,Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double-blind randomised controlled feasibility trial.,"INTRODUCTION


Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not using antithrombotic drugs. We aim to assess the feasibility of conducting a randomised controlled testing the safety and efficacy of desmopressin for patients with antiplatelet-associated ICH.
METHODS AND ANALYSIS


We aim to include 50 patients within 24 hours of spontaneous ICH onset, associated with oral antiplatelet drug(s) use in at least the preceding 7 days. Patients will be randomised (1:1) to receive intravenous desmopressin 20 µg in 50 mL sodium chloride 0.9% infused over 20 min or matching placebo. We will mask participants, relatives and outcome assessors to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, number of patients receiving allocated treatment, rate of recruitment and adherence to treatment and follow-up. Secondary outcomes include change in ICH volume at 24 hours; hyponatraemia at 24 hours, length of hospital stay, discharge destination, early death less than 28 days, death or dependency at day 90, death up to day 90, serious adverse events (including thromboembolic events) up to day 90; disability (Barthel index, day 90), quality of life (EuroQol 5D (EQ-5D), day 90), cognition (telephone mini-mental state examination day 90) and health economic assessment (EQ-5D).
ETHICS AND DISSEMINATION


The Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH) trial received ethical approval from the East Midlands-Nottingham 2 research ethics committee (18/EM/0184). The DASH trial is funded by National Institute for Health and Care Research RfPB grant: PB-PG-0816-20011. Trial results will be published in a peer reviewed academic journal and disseminated through academic conferences and through patient stroke support groups. Reporting will be in compliance with Consolidated Standards of Reporting Trials recommendations.
TRIAL REGISTRATION NUMBERS


NCT03696121; ISRCTN67038373; EudraCT 2018-001904-12.",2020,Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not using antithrombotic drugs.,"['Stroke due to Haemorrhage (DASH', 'patients with antiplatelet-associated ICH', '50 patients within 24\u2009hours of spontaneous ICH onset, associated with oral antiplatelet drug(s) use in at least the preceding 7\u2009days']","['Desmopressin', 'desmopressin', 'intravenous desmopressin 20\u2009µg in 50 mL sodium chloride 0.9% infused over 20\u2009min or matching placebo']","['rate of recruitment and adherence', 'safety and efficacy', 'change in ICH volume at 24\u2009hours; hyponatraemia at 24\u2009hours, length of hospital stay, discharge destination, early death less than 28 days, death or dependency at day 90, death up to day 90, serious adverse events (including thromboembolic events) up to day 90; disability (Barthel index, day 90), quality of life (EuroQol 5D (EQ-5D), day 90), cognition (telephone mini-mental state examination day 90) and health economic assessment (EQ-5D']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.450166,Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not using antithrombotic drugs.,"[{'ForeName': 'Michael J R', 'Initials': 'MJR', 'LastName': 'Desborough', 'Affiliation': ""Haemostasis and Thrombosis Centre, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Al-Shahi Salman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Stanworth', 'Affiliation': 'Transfusion Medicine, NHS Blood and Transplant, Oxford, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havard', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Brennan', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Dineen', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Coats', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Hepburn', 'Affiliation': 'Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK nikola.sprigg@nottingham.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-037555']
1709,33172953,Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell).,"BACKGROUND


Effective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.
METHODS AND ANALYSIS


A randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants' views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.
ETHICS AND DISSEMINATION


The trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.
TRIAL REGISTRATION NUMBER


ISRCTN85601537.",2020,"Post-intervention, there were improvements in sleep, depression and psychotic experiences.","['young people', '12 young people at ultra-high-risk of psychosis', 'Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services', 'young people at ultra-high-risk of psychosis']",['youth-focussed sleep intervention in addition to usual care or usual care alone'],"['sleep, depression and psychotic experiences', 'feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",40.0,0.24317,"Post-intervention, there were improvements in sleep, depression and psychotic experiences.","[{'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Waite', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK felicity.waite@psych.ox.ac.uk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kabir', 'Affiliation': 'The McPin Foundation, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Mollison', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Tsiachristas', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Petit', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Černis', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maughan', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2020-045235']
1710,33173114,The influence of induction speed on the frontal (processed) EEG.,"The intravenous injection of the anaesthetic propofol is clinical routine to induce loss of responsiveness (LOR). However, there are only a few studies investigating the influence of the injection rate on the frontal electroencephalogram (EEG) during LOR. Therefore, we focused on changes of the frontal EEG especially during this period. We included 18 patients which were randomly assigned to a slow or fast induction group and recorded the frontal EEG. Based on this data, we calculated the power spectral density, the band powers and band ratios. To analyse the behaviour of processed EEG parameters we calculated the beta ratio, the spectral entropy, and the spectral edge frequency. Due to the prolonged induction period in the slow injection group we were able to distinguish loss of responsiveness to verbal command (LOvR) from loss of responsiveness to painful stimulus (LOpR) whereas in the fast induction group we could not. At LOpR, we observed a higher relative alpha and beta power in the slow induction group while the relative power in the delta range was lower than in the fast induction group. When concentrating on the slow induction group the increase in relative alpha power pre-LOpR and even before LOvR indicated that frontal EEG patterns, which have been suggested as an indicator of unconsciousness, can develop before LOR. Further, LOvR was best reflected by an increase of the alpha to delta ratio, and LOpR was indicated by a decrease of the beta to alpha ratio. These findings highlight the different spectral properties of the EEG at various levels of responsiveness and underline the influence of the propofol injection rate on the frontal EEG during induction of general anesthesia.",2020,"At LOpR, we observed a higher relative alpha and beta power in the slow induction group while the relative power in the delta range was lower than in the fast induction group.",['18 patients'],"['slow or fast induction group and recorded the frontal EEG', 'anaesthetic propofol']","['relative alpha power pre-LOpR', 'relative alpha and beta power', 'loss of responsiveness (LOR', 'alpha to delta ratio, and LOpR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",18.0,0.0210335,"At LOpR, we observed a higher relative alpha and beta power in the slow induction group while the relative power in the delta range was lower than in the fast induction group.","[{'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Obert', 'Affiliation': 'Technical University of Munich, School of Medicine, Department of Anesthesiology and Intensive Care, Munich, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sepúlveda', 'Affiliation': 'Department of Anesthesiology, Hospital Base San José, Osorno/Universidad Austral, Valdivia, Chile.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kratzer', 'Affiliation': 'Technical University of Munich, School of Medicine, Department of Anesthesiology and Intensive Care, Munich, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schneider', 'Affiliation': 'Technical University of Munich, School of Medicine, Department of Anesthesiology and Intensive Care, Munich, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kreuzer', 'Affiliation': 'Technical University of Munich, School of Medicine, Department of Anesthesiology and Intensive Care, Munich, Germany. m.kreuzer@tum.de.'}]",Scientific reports,['10.1038/s41598-020-76323-8']
1711,33173165,Body mass index and body weight change during adjuvant chemotherapy in colon cancer patients: results from the AVANT trial.,"While obesity increases colorectal cancer incidence, there are inconsistent results in the prognostic role of obesity or body weight change on survival. This study investigated the prognostic impact of body weight and weight change in stage III or high risk stage II colon cancer patients. We used data from patients enrolled in the phase III AVANT trial. The AVANT trial investigated the efficacy of adding bevacizumab to standard adjuvant chemotherapy (FOFOX or XELOX). Weight change during the first 6 months of adjuvant chemotherapy was measured. Cox proportional hazard model was used to assess the prognostic influence of body weight and weight change. Among 3451 intention-to-treat population, body weight and weight change was measured in 3449 (99.9%) and 2455 (71.1%) patients, respectively. Among 2455 patients, 651 (26.5%) had weight gain over 5 kg and 179 (7.3%) had weight loss over 5 kg. Weight gain was more frequently observed in Asian and male. Neither baseline BMI nor weight change affected recurrence or survival in the Cox proportional hazard model.",2020,Neither baseline BMI nor weight change affected recurrence or survival in the Cox proportional hazard model.,"['colon cancer patients', 'patients enrolled in the phase III AVANT trial', 'stage III or high risk stage II colon cancer patients']",['bevacizumab to standard adjuvant chemotherapy (FOFOX or XELOX'],"['Body mass index and body weight change', 'weight loss', 'body weight and weight change', 'weight gain', 'Weight gain', 'baseline BMI nor weight change affected recurrence or survival', 'Weight change']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.10693,Neither baseline BMI nor weight change affected recurrence or survival in the Cox proportional hazard model.,"[{'ForeName': 'Dae-Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, 101 Daehang-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Sooyoung', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, 103 Daehang-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Aesun', 'Initials': 'A', 'LastName': 'Shin', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, 103 Daehang-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea. shinaesun@snu.ac.kr.'}, {'ForeName': 'Sae-Won', 'Initials': 'SW', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, 101 Daehang-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea. saewon1@snu.ac.kr.'}, {'ForeName': 'Tae-You', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, 101 Daehang-Ro, Jongno-Gu, Seoul, 03080, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-020-76643-9']
1712,33173886,Engineering a Mobile Platform to Promote Sleep in the Pediatric Primary Care Setting.,"BACKGROUND


Pediatricians lack tools to support families at home for the promotion of childhood sleep. We are using the Multiphase Optimization Strategy (MOST) framework to guide the development of a mobile health platform for childhood sleep promotion.
PURPOSE


Under the preparation phase of the MOST framework, to demonstrate feasibility of a mobile health platform towards treating children with insufficient sleep.
METHODS


Children aged 10-12y were enrolled (Study #1: N=30; Study #2: N=43). Participants wore a sleep tracker to measure sleep duration. Data were retrieved by a mobile health platform, programmed to send introductory messages during run-in (2 weeks) and goal achievement messages during intervention (7 weeks) periods. In study #1, participants were randomized to control, gain-framed incentive or loss-framed incentive arms. In study #2, participants were randomized to control, loss-framed incentive, normative feedback or loss-framed incentive plus normative feedback arms.
RESULTS


In study #1, 1,514 nights of data were captured (69%) and sleep duration during the intervention was higher by an average of 21 (95% CI: -8, 51) and 34 (95% CI: 7, 61) minutes per night for the gain-framed and loss-framed arms, respectively, compared to controls. In study #2, 2,689 nights of data were captured (81%), with no major differences in average sleep duration between the control and the loss-framed or normative feedback arms.
CONCLUSION


We have developed and deployed a mobile health platform that can capture sleep data and remotely communicate with families. Promising candidate intervention components will be further investigated under the optimization phase of the MOST framework.",2020,"We are using the Multiphase Optimization Strategy (MOST) framework to guide the development of a mobile health platform for childhood sleep promotion.
","['children with insufficient sleep', 'Children aged 10-12y were enrolled (Study #1: N=30; Study #2: N=43']","['control, gain-framed incentive or loss-framed incentive arms', 'control, loss-framed incentive, normative feedback or loss-framed incentive plus normative feedback arms']","['sleep duration', 'average sleep duration', 'loss-framed or normative feedback arms', 'sleep tracker to measure sleep duration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.151207,"We are using the Multiphase Optimization Strategy (MOST) framework to guide the development of a mobile health platform for childhood sleep promotion.
","[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': ''}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Williamson', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Huffnagle', 'Affiliation': ''}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Eck', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Jawahar', 'Affiliation': ''}, {'ForeName': 'Lionola', 'Initials': 'L', 'LastName': 'Juste', 'Affiliation': ''}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ''}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2020.11.06.20223719']
1713,33174068,Correction to: Effects of Dating Matters® on Sexual Violence and Sexual Harassment Outcomes among Middle School Youth: a Cluster-Randomized Controlled Trial.,A Correction to this paper has been published: https://doi.org/10.1007/s11121-020-01183-7.,2020,A Correction to this paper has been published: https://doi.org/10.1007/s11121-020-01183-7.,['Middle School Youth'],['Dating Matters®'],['Sexual Violence and Sexual Harassment Outcomes'],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0162790', 'cui_str': 'Sexual harassment'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0412578,A Correction to this paper has been published: https://doi.org/10.1007/s11121-020-01183-7.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA. sdegue@cdc.gov.'}, {'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Lianne Fuino', 'Initials': 'LF', 'LastName': 'Estefan', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Tracy', 'Affiliation': '2M Research, LLC, Arlington, TX, USA.'}, {'ForeName': 'Vi D', 'Initials': 'VD', 'LastName': 'Le', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Vivolo-Kantor', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Latzman', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Tharp', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Lang', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'NORC at the University of Chicago, Chicago, IL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01183-7']
1714,33171390,"Randomized controlled trial of community-based, post-rehabilitation exercise in COPD.","PURPOSE


Although pulmonary rehabilitation (PR) improves function in people with chronic obstructive pulmonary disease (COPD), a community-based exercise program may be necessary to maintain functional capacity. We aimed to determine the effectiveness of a post-rehabilitation, community-based maintenance program on exercise tolerance, functional capacity and quality of life.
METHODS


Patients with COPD who completed PR were randomized to receive a community-based maintenance program (intervention) or usual care (control). The primary outcome was 6-min walk distance (6MWD), measured immediately post-PR, 6 months and 12 months later. Secondary outcomes included self-reported functional capacity, health-related quality of life, self-efficacy, program cost, and lower extremity muscle strength.
RESULTS


Ninety-seven patients (69 ± 9 years) were enrolled. There was a non-significant trend of an intervention effect on 6MWD over time (β = 42, 95% CI: 0.06 to 83.93, p = 0.053). There was no significant impact of group on any of the secondary outcomes. Restricting the analysis to those who attended ≥50% of the exercise sessions showed a significant intervention effect for 6MWD (β = 69.19, 95% CI = 10.16 to 128.22, p = 0.03). The cost of participating in the community maintenance program for the intervention group was $374.77 (SD 142.12) and membership renewal was highest at community centres offering twice weekly, supervised exercise classes.
CONCLUSIONS


A post rehabilitation, community-based exercise program, will maintain exercise capacity in people with COPD who attend at least 50% of available sessions over one year. An increased focus on factors that determine adherence would help inform improvements in maintenance program design.",2020,"Restricting the analysis to those who attended ≥50% of the exercise sessions showed a significant intervention effect for 6MWD (β = 69.19, 95% CI = 10.16 to 128.22, p = 0.03).","['people with chronic obstructive pulmonary disease (COPD', 'Patients with COPD who completed PR', 'Ninety-seven patients (69\xa0±\xa09 years) were enrolled', 'people with COPD who attend at least 50% of available sessions over one year']","['community-based exercise program', 'post-rehabilitation, community-based maintenance program', 'community-based, post-rehabilitation exercise', 'pulmonary rehabilitation (PR', 'community-based maintenance program (intervention) or usual care (control']","['self-reported functional capacity, health-related quality of life, self-efficacy, program cost, and lower extremity muscle strength', '6-min walk distance (6MWD', 'exercise tolerance, functional capacity and quality of life', '6MWD over time (β\xa0']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.104461,"Restricting the analysis to those who attended ≥50% of the exercise sessions showed a significant intervention effect for 6MWD (β = 69.19, 95% CI = 10.16 to 128.22, p = 0.03).","[{'ForeName': 'Stacey J', 'Initials': 'SJ', 'LastName': 'Butler', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: stacey.butler@utoronto.ca.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Annemarie L', 'Initials': 'AL', 'LastName': 'Lee', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Physiotherapy, Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Marla K', 'Initials': 'MK', 'LastName': 'Beauchamp', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Brusco', 'Affiliation': 'Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Cabrini Health, Malvern, Victoria, Australia; School of Public Health and Preventive Medicine, Monash University, Australia.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'Goldstein', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada; School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106195']
1715,33171419,"A multi-centre, randomized, non-inferiority trial to compare ulipristal with standard surgical treatment in women with symptomatic uterine fibroids: Protocol of the MYOMEX-2 trial.","OBJECTIVES


Fibroids are the most common benign tumours found in the uterus and can cause various symptoms. In 20-50 % of the women, an intervention is required. When conservative options fail, invasive options such as hysterectomy, uterine artery embolization or myomectomy are eligible options. Ulipristal acetate (UPA) was launched as the sole available long term pharmaceutical treatment, with the potential to avoid surgery. It is suggested that UPA improves quality of life, reduces symptoms and fibroid volumes. However, UPA is an expensive medicine, is possibly associated with liver injury and has never been directly compared to surgical treatment. The aim of this trial is to compare UPA to surgical treatment on both effectiveness and cost-effectiveness. Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline. Secondary outcomes include quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference. Outcomes will be analysed according to intention-to-treat principle.
STUDY DESIGN


The MYOMEX-2 trial is an open-label, multicentre, non-inferiority randomized controlled trial. Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE). Fibroid symptoms may comprise (but are not limited to) heavy menstrual bleeding, bulk symptoms or pain. Patients are randomised 2:1 in a parallel group design between two treatment arms: 119 patients in the UPA group and 60 patients in the surgery group. Follow up comprises of online questionnaires, outpatient visits and phone appointments on several follow up moments, up to 24 months after surgery or start UPA.
REGISTRATION DETAILS


MYOMEX-2 trial; protocol version 4, date 22-02-2019; NTR6860; NL62638.029.18. All items from the World Health Organization Trial Registration Data Set are provided in the online supplementary file (Appendix-B).",2020,Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline.,"['Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE', 'women with symptomatic uterine fibroids', '119 patients in the UPA group and 60 patients in the surgery group']","['UPA', 'Ulipristal acetate (UPA', 'ulipristal with standard surgical treatment']","['quality of life, reduces symptoms and fibroid volumes', 'effectiveness and cost-effectiveness', 'reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire', 'quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0300205', 'cui_str': 'ulipristal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",,0.274217,Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline.,"[{'ForeName': 'Mei-An', 'Initials': 'MA', 'LastName': 'Middelkoop', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands; Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands. Electronic address: m.middelkoop@vumc.nl.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands; Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Marijke C Jansen', 'Initials': 'MCJ', 'LastName': 'van der Weide', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter J K', 'Initials': 'WJK', 'LastName': 'Hehenkamp', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands; Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.058']
1716,33181832,"Ibrutinib, Obinutuzumab And Venetoclax In Relapsed and Untreated Patients with Mantle-Cell Lymphoma, a phase I/II trial.","Ibrutinib, obinutuzumab plus venetoclax demonstrate synergy in pre-clinical models of mantle-cell lymphoma (MCL). OAsIs (NCT02558816), a single-arm multi-center prospective phase I/II trial, aimed to determine the maximum tolerated dose (MTD) of venetoclax in combination with fixed doses of ibrutinib and obinutuzumab, in relapsed MCL patients. At the venetoclax MTD, extension cohorts were opened for relapsed and untreated patients. Safety and efficacy were secondary objectives. Minimal residual disease (MRD) was assessed by allele-specific oligonucleotide-quantitative polymerase chain reaction (ASO-qPCR). Between Oct 14, 2015 to May 29, 2018, forty-eight patients were enrolled. No dose limiting toxicity (DLT) was reported, and venetoclax at 400mg per day was chosen for extension. Eighteen (75%) relapsed and 8 (53%) untreated patients experienced grade 3/4 adverse events (AEs). The complete response rate assessed by positron-emission tomography at the end of cycle 6 was 67% in relapsed and 86.6% in untreated patients. MRD clearance for evaluable patients was seen in 71.5% of relapsed (10 out of 14) and 100% of untreated MRD-evaluable patients (n=12), at the end of three cycles. The median follow-up (mFU) for relapsed patients was 17 months (range, 10 to 35). The 2-years PFS was 69.5% (95% CI, 52.9- 91.4%) and 68.6% (95% CI, 49.5- 95.1%) for OS. The mFU was 14 months (range, 5 to 19) for untreated patients, the 1-year PFS was 93.3% (95% CI, 81.5- 100%). Obinutuzimab, ibrutinib and venetoclax combination is well tolerated and provides high response rates including at the molecular level in relapsed and untreated MCL patients.",2020,The complete response rate assessed by positron-emission tomography at the end of cycle 6 was 67% in relapsed and 86.6% in untreated patients.,"['mantle-cell lymphoma (MCL', 'relapsed MCL patients', 'Between Oct 14, 2015 to May 29, 2018, forty-eight patients were enrolled']","['Ibrutinib, Obinutuzumab And Venetoclax', 'Ibrutinib, obinutuzumab plus venetoclax', 'Obinutuzimab, ibrutinib and venetoclax combination']","['Safety and efficacy', '2-years PFS', 'Minimal residual disease (MRD', 'MRD clearance', 'complete response rate assessed by positron-emission tomography', 'grade 3/4 adverse events (AEs', '1-year PFS']","[{'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",48.0,0.0504535,The complete response rate assessed by positron-emission tomography at the end of cycle 6 was 67% in relapsed and 86.6% in untreated patients.,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'CHU nantes, Nantes, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'CHU Lille, ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chiron', 'Affiliation': 'CRCNA, INSERM, CNRS, Université de Nantes, Nantes, France., Nantes, France.'}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': ""Service d'Hématologie clinique et Thérapie cellulaire, PESSAC, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'CHU Montpellier UMR5535, Montpellier, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'C.H.U Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bodet-Milin', 'Affiliation': 'CHU Nantes.'}, {'ForeName': 'Sylviane', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'chu dijon, dijon, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Bossard', 'Affiliation': 'CHU Nantes, Nantes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Nadal', 'Affiliation': 'University hospital of Dijon, DIJON, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Herbaux', 'Affiliation': 'Lille University Hospital.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Tessoulin', 'Affiliation': 'Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Tchernonog', 'Affiliation': 'CHU Montpellier, Hopital Saint Eloi, MONTPELLIER, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'inserm, France.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'McCulloch', 'Affiliation': 'University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gastinne', 'Affiliation': 'Nantes University hospital, Nantes, France.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Callanan', 'Affiliation': 'Universite Bourgogne-Franche Comte-INSERM1231, CHU Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rule', 'Affiliation': 'Plymouth University Medical School, Plymouth, United Kingdom.'}]",Blood,['10.1182/blood.2020008727']
1717,33181843,Effect of Whitening Toothpastes and Brushing on Microhardness of Esthetic Restorative Materials.,"OBJECTIVE


Whitening toothpastes are widely used. Hence, it is important to understand their effect on the surface properties of restorative materials. To evaluate the effect of three over-the-counter whitening toothpastes and toothbrushing simulation on microhardness of three restorative materials.
STUDY DESIGN


Forty cylindrical (10×2mm) specimens were prepared from each restorative material and randomly assigned into four groups/10 each according to the whitening toothpastes used and distilled water (control). All specimens were measured for microhardness (Baseline-T1). The specimens were brushed with a soft brush using an in vitro tooth-brushing simulator with the assigned whitening toothpaste using the same setting for brushing cycles/load for all groups. Specimens were then measured for microhardness (T2) similar to baseline.
RESULTS


The highest (mean±SD) microhardness after application of the whitening toothpastes and brushing was recorded for Intense White and Filtek Z250 XT (127.6±1.8), followed by Optic White and Fuji ll LC (73.9±0.9) and Optic White and Photac Fill (72.7±1.3). There was statistically significant difference for microhardness between pre- and post-application of the whitening toothpastes and brushing for all tested restorative materials (P=0.0001). The microhardness of Filtek Z250XT with 3D White post-application of the whitening toothpastes and brushing was lowest compared to other toothpastes and control (P=0.0001).
CONCLUSION


Microhardness increased after application of the whitening toothpastes and toothbrushing simulation for all combination of tested restorative materials and whitening toothpastes. The microhardness of FIiltek Z250XT with 3D White post-application of the whitening toothpastes and brushing was lowest compared to other toothpastes and control.",2020,There was statistically significant difference for microhardness between pre- and post-application of the whitening toothpastes and brushing for all tested restorative materials (P=0.0001).,"['Forty cylindrical (10×2mm) specimens were prepared from each restorative material', 'Microhardness of Esthetic Restorative Materials']","['whitening toothpastes used and distilled water (control', 'Whitening Toothpastes']",[],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0207144,There was statistically significant difference for microhardness between pre- and post-application of the whitening toothpastes and brushing for all tested restorative materials (P=0.0001).,"[{'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Salama', 'Affiliation': ''}, {'ForeName': 'Faika', 'Initials': 'F', 'LastName': 'Abdelmegid', 'Affiliation': ''}, {'ForeName': 'Lamya', 'Initials': 'L', 'LastName': 'Alhomaidhi', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Alswayyed', 'Affiliation': ''}, {'ForeName': 'Shatha', 'Initials': 'S', 'LastName': 'Alfarraj', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-44.5.2']
1718,33181849,Antimicrobial Effect of Propolis Administered through Two Different Vehicles in High Caries Risk Children: A Randomized Clinical Trial.,"OBJECTIVE


To investigate the effect of two methods of propolis administration on plaque accumulation and microbial count as well as patient acceptance of each vehicle.
STUDY DESIGN


A randomized clinical trial with two parallel arms was used with a sample of 60 high caries risk children 6-8 years old. Children were divided randomly into two groups. Group I: Children who received propolis chewing gum and instructed to chew it twice daily for at least twenty minutes, for two weeks. Group II: children who received propolis mouthwash and instructed to rinse twice daily for one minute. A plaque index was recorded and a plaque sample was collected from all participants at base line and after two weeks of treatment. All participants were asked to rate the preparation they received during treatment period on a Visual Analogue Scale chart.
RESULTS


Data showed that propolis had a significant effect on reducing plaque scores and colony counts in both vehicles. There was no significant difference between both vehicles neither on plaque reduction nor on microbial count. However children preferred the gum formula.
CONCLUSION


Propolis in both vehicles reduced plaque accumulation and microbial count which recommends its use as an antimicrobial agent in different vehicles.",2020,There was no significant difference between both vehicles neither on plaque reduction nor on microbial count.,"['60 high caries risk children 6-8 years old', 'High Caries Risk Children']","['propolis mouthwash', 'propolis chewing gum', 'propolis administration', 'Propolis Administered through Two Different Vehicles']","['plaque accumulation and microbial count', 'plaque scores and colony counts', 'plaque reduction nor on microbial count']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",60.0,0.0443784,There was no significant difference between both vehicles neither on plaque reduction nor on microbial count.,"[{'ForeName': 'Hend S', 'Initials': 'HS', 'LastName': 'El-Allaky', 'Affiliation': ''}, {'ForeName': 'Nadia A', 'Initials': 'NA', 'LastName': 'Wahba', 'Affiliation': ''}, {'ForeName': 'Dalia M', 'Initials': 'DM', 'LastName': 'Talaat', 'Affiliation': ''}, {'ForeName': 'Azza S', 'Initials': 'AS', 'LastName': 'Zakaria', 'Affiliation': ''}]",The Journal of clinical pediatric dentistry,['10.17796/1053-4625-44.5.1']
1719,33183325,Effect of thoracic paravertebral nerve block on the early postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery.,"OBJECTIVE


To evaluate the effect of thoracic paravertebral nerve block on early postoperative rehabilitation in patients undergoing radical thoracoscopic surgery for lung cancer.
METHODS


Ninety patients scheduled for elective video-assisted thoracoscopic lobectomy of lung cancer were divided into 2 groups: the general anesthesia group (GA group, n = 45) and the TPVB group (TP group, n = 45). The primary outcome was the decline rate of the 6-min walking test (6MWT); the second outcomes were as follows: absolute value and the completion rate of 6MWT, postoperative analgesia deficiency and pain scores, oxycodone consumption, sleep quality, the incidence of postoperative pulmonary complications, and the hospital stay.
RESULTS


Compared with the GA group, the TP group had a lower decline rate of the 6MWT on POD1 and POD2. The walking distance on POD1 and POD2 in the TP group was significantly longer than that in the GA group; the completion rate at POD1 in the TP group was higher than that in the GA group. The pain scores and oxycodone consumption at POD1 in the TP group were lower than the GA group. The sleep quality in the TP group was higher than the GA group.
CONCLUSIONS


TPVB can significantly improve postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery, which is helpful for promoting the early recovery of patients.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900026213. Registered 26 Sept. 2019, http://www.chictr.org.cn/showproj.aspx?proj=43733 .",2020,"Compared with the GA group, the TP group had a lower decline rate of the 6MWT on POD1 and POD2.","['patients undergoing thoracoscopic radical lung cancer surgery', 'Ninety patients scheduled for', 'patients undergoing radical thoracoscopic surgery for lung cancer']","['GA', 'TPVB', 'general anesthesia group (GA group, n = 45) and the TPVB group (TP', 'thoracic paravertebral nerve block', 'elective video-assisted thoracoscopic lobectomy of lung cancer']","['decline rate of the 6-min walking test (6MWT); the second outcomes were as follows: absolute value and the completion rate of 6MWT, postoperative analgesia deficiency and pain scores, oxycodone consumption, sleep quality, the incidence of postoperative pulmonary complications, and the hospital stay', 'walking distance on POD1 and POD2', 'POD1 and POD2', 'completion rate at POD1', 'pain scores and oxycodone consumption at POD1', 'sleep quality', 'postoperative rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0521223', 'cui_str': 'Thoracoscopic lobectomy of lung'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]",90.0,0.0485528,"Compared with the GA group, the TP group had a lower decline rate of the 6MWT on POD1 and POD2.","[{'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Kang', 'Affiliation': ""Department of Perioperative Medicine and Anesthesiology, Henan University People's Hospital; Henan Provincial People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': ""Department of Perioperative Medicine and Anesthesiology, Henan University People's Hospital; Henan Provincial People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""Department of Perioperative Medicine and Anesthesiology, Henan University People's Hospital; Henan Provincial People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China.""}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""Department of Perioperative Medicine and Anesthesiology, Henan University People's Hospital; Henan Provincial People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China.""}, {'ForeName': 'Erhu', 'Initials': 'E', 'LastName': 'Tian', 'Affiliation': ""Department of Cardiology, Henan University People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China.""}, {'ForeName': 'Jiaqiang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Perioperative Medicine and Anesthesiology, Henan University People's Hospital; Henan Provincial People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Perioperative Medicine and Anesthesiology, Henan University People's Hospital; Henan Provincial People's Hospital, No. 7, Weiwu Road, Zhengzhou City, Henan Province, China. 457106786@qq.com.""}]",World journal of surgical oncology,['10.1186/s12957-020-02071-8']
1720,33183345,Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide: study protocol for a randomized controlled trial in veterans.,"BACKGROUND


At least 17 veterans die every day from suicide. Although existing treatments such as brief cognitive behavioral therapy (BCBT) have been found to reduce suicide attempts in military personnel, a number of patients go on to attempt suicide after completing therapy. Thus, finding ways to enhance treatment efficacy to reduce suicide is critical. Repetitive transcranial magnetic stimulation (TMS) is a noninvasive technique that can be used to stimulate brain regions that are impaired in suicidal patients, that has been successfully used to augment treatments for psychiatric disorders implicated in suicide. The goal of this study is to test whether augmenting BCBT with TMS in suicidal veterans reduces rates of suicidal ideation, attempts, and other deleterious treatment outcomes.
METHODS


One hundred thirty veterans with a suicide plan or suicidal behavior in the prior 2 weeks will be recruited from inpatient and outpatient settings at the Providence VA Medical Center in the USA. Veterans will be randomly assigned to receive 30 daily sessions of active or sham TMS in concert with a 12-week BCBT protocol in a parallel group design. Veterans will complete interviews and questionnaires related to psychiatric symptoms, suicidal ideation and behavior, treatment utilization, and functioning during a baseline assessment prior to treatment, at treatment endpoint, and 6- and 12-month follow-ups. Primary analyses will use mixed effect regressions to examine effects of treatment condition on suicidal behaviors, improvements in psychosocial functioning, and psychiatric hospitalization. Similar models as well as exploratory latent growth curve analyses will examine mediators and moderators of treatment effects.
DISCUSSION


This protocol provides a framework for designing multilayered treatment studies for suicide. When completed, this study will be the first clinical trial evaluating the efficacy of augmenting BCBT for suicide with TMS. The results of this trial will have implications for treatment of suicide ideation and behaviors and implementation of augmented treatment designs. If positive, results from this study can be rapidly implemented across the VA system and will have a direct and meaningful impact on veteran suicide.
TRIAL REGISTRATION


This study was registered prior to participant enrollment with ClinicalTrials.gov NCT03952468 . Registered on May 16, 2019.
TRIAL SPONSOR CONTACT


Robert O'Brien (VA Health Services R&D), robert.obrien7@va.gov.",2020,"Although existing treatments such as brief cognitive behavioral therapy (BCBT) have been found to reduce suicide attempts in military personnel, a number of patients go on to attempt suicide after completing therapy.","['One hundred thirty veterans with a suicide plan or suicidal behavior in the prior 2\xa0weeks will be recruited from inpatient and outpatient settings at the Providence VA Medical Center in the USA', 'suicidal patients', 'suicidal veterans', 'veterans', 'suicide', 'At least 17 veterans die every day from suicide']","['Repetitive transcranial magnetic stimulation (TMS', 'BCBT', 'Combined transcranial magnetic stimulation and brief cognitive behavioral therapy', '30 daily sessions of active or sham TMS', 'cognitive behavioral therapy (BCBT', 'BCBT with TMS']","['suicidal behaviors, improvements in psychosocial functioning, and psychiatric hospitalization']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.126792,"Although existing treatments such as brief cognitive behavioral therapy (BCBT) have been found to reduce suicide attempts in military personnel, a number of patients go on to attempt suicide after completing therapy.","[{'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Bozzay', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Box G-BH, Providence, RI, 02912, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Primack', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Box G-BH, Providence, RI, 02912, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, 830 Chalkstone Boulevard, Providence, RI, 02908, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Box G-BH, Providence, RI, 02912, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Box G-BH, Providence, RI, 02912, USA. Noah_Philip@brown.edu.'}]",Trials,['10.1186/s13063-020-04870-6']
1721,33183553,Intensive nutrition counseling as part of a multi-component weight loss intervention improves diet quality and anthropometrics in older adults with obesity.,"BACKGROUND AND AIMS


Obesity significantly impacts older adults. Intensive nutrition counseling can aid in weight reduction and improve diet quality, but data are sparse in this population. The objective of this intervention is to determine how intensive nutrition counseling affects diet quality and anthropometric measures during a multi-component weight loss intervention in rural older adults with obesity.
METHODS


A series of 12-week, single-arm feasibility pilots were conducted in fall 2017 and winter/spring 2018 in a community aging center in rural Northern New England. Adults were eligible if ≥ 65 years old with a Body Mass Index (BMI) ≥30 kg/m 2 . Exclusion criteria included dementia/cognitive impairment, uncontrolled psychiatric illness, weight-loss surgery, weight loss >5% in previous 6-months, life-threatening illness, palliative/hospice services, current participation in another weight-loss study/program, obesogenic medications, or presence of major chronic conditions. Participants received once-weekly nutrition counseling by a registered dietitian nutritionist (RDN), and twice-weekly exercise sessions by a physical therapist (PT). Primary outcomes were diet quality changes measured by total Rapid Eating and Activity Assessment for Patients-Short Version (REAP-S) and Automated Self-Administered 24-h dietary recall (ASA-24). Secondary outcome measures were changes in weight (kilograms) and waist circumference (centimeters). McNemar test was conducted for all paired categorical data while paired t-tests were conducted for all paired continuous data. All analyses were conducted in R; p-value<0.05 was significant.
RESULTS


Total n = 23. Mean age was 72.2 (5.8) years (73.9% female); mean BMI was 35.9 ± 5.0 kg/m 2 . At 12 weeks, diet quality significantly improved. REAP-S scores increased by 3.53 ± 3.13 points (p < 0.001). Kilocalories, grams fat, grams saturated fat, milligrams sodium, grams added sugar, and grams alcohol via ASA-24 significantly decreased (all p < 0.05). Significant reductions in weight (-5.22 ± 3.13 kg) and waist circumference (-6.88 ± 5.67 cm) were observed (both p < 0.001).
CONCLUSION


Intensive nutrition counseling significantly enhances diet quality and reduces weight and waist circumference in rural older adults with obesity.",2020,REAP-S scores increased by 3.53 ± 3.13 points (p < 0.001).,"['older adults', 'rural older adults with obesity', 'Adults were eligible if\xa0≥\xa065 years old with a Body Mass Index (BMI) ≥30\xa0kg/m 2 ', 'Total n\xa0', 'Mean age was 72.2 (5.8) years (73.9% female); mean BMI was 35.9 ± 5.0 kg/m 2 ', 'Exclusion criteria included dementia/cognitive impairment, uncontrolled psychiatric illness, weight-loss surgery, weight loss >5% in previous 6-months, life-threatening illness, palliative/hospice services, current participation in another weight-loss study/program, obesogenic medications, or presence of major chronic conditions', 'older adults with obesity', 'A series of 12-week, single-arm feasibility pilots were conducted in fall 2017 and winter/spring 2018 in a community aging center in rural Northern New England']","['multi-component weight loss intervention', 'Intensive nutrition counseling', 'intensive nutrition counseling', 'once-weekly nutrition counseling by a registered dietitian nutritionist (RDN), and twice-weekly exercise sessions by a physical therapist (PT']","['weight', 'changes in weight (kilograms) and waist circumference (centimeters', 'diet quality changes measured by total Rapid Eating and Activity Assessment for Patients-Short Version (REAP-S) and Automated Self-Administered 24-h dietary recall (ASA-24', 'waist circumference', 'diet quality', 'REAP-S scores', 'diet quality and anthropometric measures', 'diet quality and anthropometrics', 'weight reduction and improve diet quality', 'Kilocalories, grams fat, grams saturated fat, milligrams sodium, grams added sugar, and grams alcohol via ASA-24', 'weight and waist circumference']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027965', 'cui_str': 'Northeastern United States'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",,0.0337581,REAP-S scores increased by 3.53 ± 3.13 points (p < 0.001).,"[{'ForeName': 'Rima Itani', 'Initials': 'RI', 'LastName': 'Al-Nimr', 'Affiliation': 'The Geisel School of Medicine at Dartmouth, 1 Rope Ferry Road Hanover, NH, 03755, USA; Department of Internal Medicine, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive Lebanon, NH, 03766, USA. Electronic address: rima.al-nimr@dartmouth.edu.'}, {'ForeName': 'K C S', 'Initials': 'KCS', 'LastName': 'Wright', 'Affiliation': 'Department of Internal Medicine, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive Lebanon, NH, 03766, USA; Wildberrycommunications.com, 1106 Lakeshore Drive, New London, NH, 03257, USA. Electronic address: kc@wildberrycommunications.com.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Aquila', 'Affiliation': 'Department of Internal Medicine, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive Lebanon, NH, 03766, USA. Electronic address: christina.l.aquila@hitchcock.org.'}, {'ForeName': 'Curtis L', 'Initials': 'CL', 'LastName': 'Petersen', 'Affiliation': 'The Geisel School of Medicine at Dartmouth, 1 Rope Ferry Road Hanover, NH, 03755, USA; The Dartmouth Institute for Health Policy,1 Medical Center Drive, Lebanon, NH, 03766, USA. Electronic address: curtis.l.petersen.gr@dartmouth.edu.'}, {'ForeName': 'Tyler L', 'Initials': 'TL', 'LastName': 'Gooding', 'Affiliation': 'Department of Internal Medicine, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive Lebanon, NH, 03766, USA. Electronic address: tyler.l.gooding@dartmouth.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Batsis', 'Affiliation': 'The Geisel School of Medicine at Dartmouth, 1 Rope Ferry Road Hanover, NH, 03755, USA; Department of Internal Medicine, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive Lebanon, NH, 03766, USA; The Dartmouth Institute for Health Policy,1 Medical Center Drive, Lebanon, NH, 03766, USA; Division of Geriatric Medicine, Center for Aging and Health, Department of Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, HC, 27517, USA. Electronic address: John.Batsis@gmail.com.'}]",Clinical nutrition ESPEN,['10.1016/j.clnesp.2020.09.002']
1722,33184084,"NTNU intranasal naloxone trial (NINA-1) study protocol for a double-blind, double-dummy, non-inferiority randomised controlled trial comparing intranasal 1.4 mg to intramuscular 0.8 mg naloxone for prehospital use.","INTRODUCTION


Intranasal (IN) naloxone is widely used to treat opioid overdoses. The advantage of nasal administration compared with injection lies in its suitability for administration by lay people as it is needless. Approved formulations of nasal naloxone with bioavailability of approximately 50% have only undergone trials in healthy volunteers, while off-label nasal sprays with low bioavailability have been studied in patients. Randomised clinical trials are needed to investigate efficacy and safety of approved IN naloxone in patients suffering overdose. This study investigates whether the administration of 1.4 mg naloxone in 0.1 mL per dose is non-inferior to 0.8 mg intramuscular injection in patients treated for opioid overdose.
METHODS AND ANALYSIS


Sponsor is the Norwegian University of Science and Technology. The study has been developed in collaboration with user representatives. The primary endpoint is the restoration of spontaneous respiration≥10 breaths/min based on a sample of 200 opioid overdose cases. Double-dummy design ensures blinding, which will be maintained until the database is locked.
ETHICS AND DISSEMINATION


The study was approved by the Norwegian Medicines Agency and Regional Ethics Committees (REC: 2016/2000). It adheres to the Good Clinical Practice guidelines as set out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.Informed consent will be sought through a differentiated model. This allows for deferred consent after inclusion for patients who have regained the ability to consent. Patients who are unable to consent prior to discharge by emergency services are given written information and can withdraw at a later date in line with user recommendations. Metadata will be published in the Norwegian University of Science and Technology Open repository. Deidentified individual participant data will be made available to recipients conditional of data processor agreement being entered.
TRIAL REGISTRATION NUMBERS


EudraCT Registry (2016-004072-22) and Clinicaltrials.gov Registry (NCT03518021).",2020,"This study investigates whether the administration of 1.4 mg naloxone in 0.1 mL per dose is non-inferior to 0.8 mg intramuscular injection in patients treated for opioid overdose.
","['healthy volunteers', 'patients suffering overdose', 'Sponsor is the Norwegian University of Science and Technology', 'patients treated for opioid overdose', 'Patients who are unable to consent prior to discharge by emergency services']","['intranasal 1.4 mg to intramuscular 0.8 mg naloxone', 'nasal naloxone', 'naloxone']",['restoration of spontaneous respiration≥10 breaths/min based on a sample of 200 opioid overdose cases'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",200.0,0.345397,"This study investigates whether the administration of 1.4 mg naloxone in 0.1 mL per dose is non-inferior to 0.8 mg intramuscular injection in patients treated for opioid overdose.
","[{'ForeName': 'Arne Kristian', 'Initials': 'AK', 'LastName': 'Skulberg', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway arne.skulberg@ntnu.no.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Tylleskär', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Anne-Cathrine', 'Initials': 'AC', 'LastName': 'Braarud', 'Affiliation': 'Division of Prehospital Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Dale', 'Affiliation': 'Clinic of Emergency Medicine and Prehospital Care, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Fridtjof', 'Initials': 'F', 'LastName': 'Heyerdahl', 'Affiliation': 'Division of Prehospital Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sindre', 'Initials': 'S', 'LastName': 'Mellesmo', 'Affiliation': 'Division of Prehospital Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Valberg', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Dale', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}]",BMJ open,['10.1136/bmjopen-2020-041556']
1723,33184089,Thromboelastography-guided blood transfusion during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy: study protocol for a prospective randomised controlled trial.,"INTRODUCTION


Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is a well-established treatment for peritoneal cancer (PC). However, this kind of combination therapy is associated with a high incidence of complications. Moreover, relative studies have indicated that traditional laboratory testing is insufficient to demonstrate the overall haemostatic physiology of CRS/HIPEC. Thromboelastography (TEG), administered by monitoring dynamic changes in haemostasis, has been shown to contribute to reducing transfusion requirements and improving survival. However, there is no evidence to verify whether TEG can be applied to guide transfusion strategies during CRS/HIPEC. Therefore, we aim to investigate whether TEG-guided blood product transfusion (TEG-BT) therapy is superior to traditional blood product transfusion (T-BT) therapy for guiding perioperative blood transfusion treatment and improving the prognosis of patients undergoing CRS/HIPEC.
METHODS AND ANALYSIS


The TEG-BT versus T-BT study is a single-centre, randomised, blinded outcome assessment clinical trial of 162 patients with PC, aged 18-64 years and undergoing CRS/HIPEC. Participants will be randomly allocated to receive TEG-BT or T-BT. The primary outcome will be the evaluation of perioperative blood transfusion, which refers to the total amount of blood transfusion given from the time patients enter the operating room up to 72 hours postoperatively. The secondary outcomes will include the transfusion volume during surgery, total amount of intraoperative infusion, amount of blood lost during the operation, total blood transfusion between 0 and 72 hours after surgery, lowest haemoglobin level within 72 hours after surgery, intensive care unit duration, overall length of stay, total cost of hospitalisation and adverse events. Data will be analysed according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Scientific Research Ethics Committee of Beijing Shijitan Hospital Affiliated with Capital Medical University (Approval Number: sjtkyll-lx-2020-3). The results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR2000028835).",2020,"The TEG-BT versus T-BT study is a single-centre, randomised, blinded outcome assessment clinical trial of 162 patients with PC, aged 18-64 years and undergoing CRS/HIPEC.","['162 patients with PC, aged 18-64 years and undergoing CRS/HIPEC', 'peritoneal cancer (PC', 'patients undergoing CRS/HIPEC', 'Beijing Shijitan Hospital Affiliated with Capital Medical University']","['TEG-guided blood product transfusion (TEG-BT) therapy', 'Thromboelastography (TEG', 'TEG', 'traditional blood product transfusion (T-BT) therapy', 'TEG-BT or T-BT', 'Thromboelastography-guided blood transfusion during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy', 'Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC']","['evaluation of perioperative blood transfusion, which refers to the total amount of blood transfusion given from the time patients enter the operating room up to 72\u2009hours postoperatively', 'transfusion volume during surgery, total amount of intraoperative infusion, amount of blood lost during the operation, total blood transfusion between 0 and 72 hours after surgery, lowest haemoglobin level within 72 hours after surgery, intensive care unit duration, overall length of stay, total cost of hospitalisation and adverse events']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",162.0,0.164499,"The TEG-BT versus T-BT study is a single-centre, randomised, blinded outcome assessment clinical trial of 162 patients with PC, aged 18-64 years and undergoing CRS/HIPEC.","[{'ForeName': 'Shaoheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Linfeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Blood Transfusion, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Peritoneal Cancer Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Peng Fei', 'Initials': 'PF', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China sfflpf@126.com.'}]",BMJ open,['10.1136/bmjopen-2020-042741']
1724,33184097,Impact of clinical versus radiographic progression on clinical outcomes in metastatic castration-resistant prostate cancer.,"OBJECTIVES


Unequivocal clinical progression (UCP)-a worsening of clinical status with or without radiographic progression (RAD)-represents a distinct mode of disease progression in metastatic prostate cancer. We evaluated the prevalence, risk factors and the impact of UCP on survival outcomes.
METHODS


A post-hoc analysis of the COU-AA-302, a randomised phase 3 study of abiraterone plus prednisone (AAP) versus prednisone was performed. Baseline characteristics were summarised. Cox proportional-hazards model and Kaplan-Meier method were used for survival and time to event analyses, respectively. Iterative multiple imputation method was used for correlation between clinicoradiographic progression-free survival (crPFS) and overall survival (OS).
RESULTS


Of 736 patients with disease progression, 280 (38%) had UCP-only and 124 (17%) had UCP plus RAD. Prognostic index model high-risk group was associated with increased likelihood of UCP (p<0.0001). Median OS was 25.7 months in UCP-only and 33.0 months for RAD-only (HR 1.39; 95% CI 1.16 to 1.66; p=0.0003). UCP adversely impacted OS in both treatment groups. Lowest OS was seen in patients with prostate specific antigen (PSA)-non-response plus UCP-only progression (median OS 22.6 months (95% CI 20.7 to 24.4)). Including UCP events lowered estimates of treatment benefit-median crPFS was 13.3 months (95% CI 11.1 to 13.8) versus median rPFS of 16.5 months (95% CI 13.8 to 16.8) in AAP group. Finally, crPFS showed high correlation with OS (r=0.67; 95% CI 0.63 to 0.71).
CONCLUSIONS


UCP is a common and clinically relevant phenomenon in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with AAP or prednisone. UCP is prognostic and associated with inferior OS and post-progression survival. A combination of PSA-non-response and UCP identifies patients with poorest survival. When included in PFS analysis, UCP diminishes estimates of treatment benefit. Continued study of UCP in mCRPC is warranted.",2020,Prognostic index model high-risk group was associated with increased likelihood of UCP (p<0.0001).,"['metastatic castration-resistant prostate cancer', 'metastatic prostate cancer', 'patients with metastatic castration-resistant prostate cancer (mCRPC) treated with', '736 patients with disease progression, 280 (38%) had UCP-only and 124 (17%) had UCP plus RAD']","['UCP', 'radiographic progression', 'AAP or prednisone', 'abiraterone plus prednisone (AAP) versus prednisone']","['Median OS', 'clinicoradiographic progression-free survival (crPFS) and overall survival (OS', 'median rPFS']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",736.0,0.0616315,Prognostic index model high-risk group was associated with increased likelihood of UCP (p<0.0001).,"[{'ForeName': 'Arpit', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota, USA raoa@umn.edu.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Oncology Development, Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Yu', 'Affiliation': 'Janssen Research & Development, Los Angeles, California, USA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Londhe', 'Affiliation': 'Oncology Development, Janssen Research & Development, Titusville, New Jersey, USA.'}, {'ForeName': 'Keqin', 'Initials': 'K', 'LastName': 'Qi', 'Affiliation': 'Oncology Development, Janssen Research & Development, Titusville, New Jersey, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota, USA.'}]",ESMO open,['10.1136/esmoopen-2020-000943']
1725,33184151,"A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, Maternal, and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study.","OBJECTIVE


SMART-GDM examined whether Habits-GDM, a smartphone application (app) coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control and maternal and neonatal outcomes in gestational diabetes mellitus (GDM).
RESEARCH DESIGN AND METHODS


In this randomized controlled trial, women diagnosed with GDM between 12 and 30 weeks were randomly assigned to usual care (control) or to additional support from Habits-GDM that integrated dietary, physical activity, weight, and glucose monitoring (intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute GWG, glycemic control, and maternal, delivery, and neonatal outcomes.
RESULTS


In total, 340 women were randomized (170 intervention, 170 control; mean ± SD age 32.0 ± 4.2 years; mean BMI 25.6 ± 5.6 kg/m 2 ). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in the intervention group (mean difference -0.15 mmol/L [95% CI -0.26; -0.03],  P  = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68 [95% CI 0.53; 0.87],  P  = 0.003; 2-h postmeal: 19.9% vs. 50%, 0.54 [0.42; 0.70],  P  < 0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, and perinatal death) were significantly lower in the intervention group (38.1% vs. 53.7%, 0.53 [0.34; 0.84],  P  = 0.006).
CONCLUSIONS


When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (nonprespecified) but did not reduce EGWG among women with GDM.",2020,"Average glucose readings were lower in the intervention group (mean difference -0.15 mmol/L [95% CI -0.26; -0.03],  P  = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68","['women with GDM', 'women diagnosed with GDM between 12 and 30 weeks', '340 women were randomized (170 intervention, 170 control; mean ± SD age 32.0 ± 4.2 years', 'With Gestational Diabetes Mellitus', 'Women', 'gestational diabetes mellitus (GDM']","['smartphone application (app) coaching program', 'usual care (control) or to additional support from Habits-GDM that integrated dietary, physical activity, weight, and glucose monitoring (intervention', 'Smartphone Application-Based Lifestyle Coaching Program']","['proportion of participants with EGWG', 'proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes', 'absolute GWG, glycemic control, and maternal, delivery, and neonatal outcomes', 'excessive gestational weight gain (EGWG', 'Gestational Weight Gain, Glycemic Control, Maternal, and Neonatal Outcomes', 'overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, and perinatal death', 'Average glucose readings', 'maternal glycemic control and composite neonatal outcomes (nonprespecified', 'proportions of glucose above targets']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",340.0,0.169647,"Average glucose readings were lower in the intervention group (mean difference -0.15 mmol/L [95% CI -0.26; -0.03],  P  = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68","[{'ForeName': 'Tong Wei', 'Initials': 'TW', 'LastName': 'Yew', 'Affiliation': 'Department of Medicine, National University Hospital, Singapore tong_wei_yew@nuhs.edu.sg.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Chi', 'Affiliation': 'Department of Obstetrics and Gynecology, National University Hospital, Singapore.'}, {'ForeName': 'Shiao-Yng', 'Initials': 'SY', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynecology, National University Hospital, Singapore.'}, {'ForeName': 'Rob M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Whitton', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Chang Siang', 'Initials': 'CS', 'LastName': 'Lim', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Pin Sym', 'Initials': 'PS', 'LastName': 'Foong', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Winni', 'Initials': 'W', 'LastName': 'Fransisca', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Chieu Leng', 'Initials': 'CL', 'LastName': 'Teoh', 'Affiliation': 'Department of Nursing, National University Hospital, Singapore.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, National University Hospital, Singapore.'}, {'ForeName': 'Su Tin', 'Initials': 'ST', 'LastName': 'Ho-Lim', 'Affiliation': 'Department of Nursing, National University Hospital, Singapore.'}, {'ForeName': 'Su Lin', 'Initials': 'SL', 'LastName': 'Lim', 'Affiliation': 'Department of Dietetics, National University Hospital, Singapore.'}, {'ForeName': 'Kai Wen', 'Initials': 'KW', 'LastName': 'Ong', 'Affiliation': 'Department of Dietetics, National University Hospital, Singapore.'}, {'ForeName': 'Peck-Hoon', 'Initials': 'PH', 'LastName': 'Ong', 'Affiliation': 'Singapore Institute of Technology, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'E Shyong', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Department of Medicine, National University Hospital, Singapore.'}]",Diabetes care,['10.2337/dc20-1216']
1726,33187485,Design and impact evaluation of a digital reproductive health program in Rwanda using a cluster randomized design: study protocol.,"BACKGROUND


Rwandan adolescents have limited access to high-quality family planning and reproductive health (FP/RH) information and care to prevent unplanned pregnancy and HIV/STIs. In addition to the immediate implications for health and well-being, teenage pregnancy is a significant cause of school drop-out, limiting girls' future potential and employment opportunities. This study introduces a direct-to-consumer digital education program that uses storytelling to deliver age-appropriate FP/RH information and economic empowerment training to adolescents. It also facilitates access to high-quality, youth-friendly FP/RH care and products. We evaluate two different school-based models of its implementation to understand how to optimize the uptake of contraception and HIV testing among adolescents.
METHODS


The study consists of two distinct phases. The first formative intervention design phase, conducted from 2016 to 2019, used a human-centered design methodology to develop the intervention alongside over 600 Rwandan adolescents, their parents, teachers, and healthcare providers. Through this methodology, we sought to maximize the fit between evidence-based practices (uptake of modern contraception and HIV testing) and the implementation context of adolescents in Rwanda. The second phase is an impact evaluation, in which we will use a Hybrid Trial Type 2 Effectiveness-Implementation study design to determine the overall effectiveness of this digital intervention as well as the relative effectiveness of the two different school-based implementation models. This takes the form of a 3-arm cluster-randomized non-inferiority trial, with a sample of 6000 youth aged 12-19 in 60 schools across 8 districts in Rwanda. Primary outcome measures include use of modern contraception, delayed initiation of childbearing, and uptake of HIV testing.
DISCUSSION


This study will yield insights into not only whether this digital intervention is successful in achieving the intended sexual and reproductive health outcomes, but also which mechanisms are likely to drive this effectiveness. The methodologies used are broadly applicable to the design, implementation, and evaluation of other behavior-based health programs in low and middle-income countries.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04198272 . Prospectively registered 13 December 2019.",2020,"This study will yield insights into not only whether this digital intervention is successful in achieving the intended sexual and reproductive health outcomes, but also which mechanisms are likely to drive this effectiveness.","['6000 youth aged 12-19 in 60 schools across 8 districts in Rwanda', 'Prospectively registered 13 December 2019', 'adolescents in Rwanda', '600 Rwandan adolescents, their parents, teachers, and healthcare providers', 'Rwandan adolescents', 'adolescents']",['digital reproductive health program'],"['use of modern contraception, delayed initiation of childbearing, and uptake of HIV testing']","[{'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}]",6000.0,0.0932099,"This study will yield insights into not only whether this digital intervention is successful in achieving the intended sexual and reproductive health outcomes, but also which mechanisms are likely to drive this effectiveness.","[{'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Nolan', 'Affiliation': 'School of Public Health, University of California, Berkeley, 2121 Berkeley Way West, MC 7360, Berkeley, CA, 94720, USA. cara_nolan@berkeley.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Packel', 'Affiliation': 'School of Public Health, University of California, Berkeley, 2121 Berkeley Way West, MC 7360, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hope', 'Affiliation': 'YLabs, 2nd Floor, Golden Plaza, KG 546 St. Kacyiru, Kigali, Rwanda.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Levine', 'Affiliation': 'YLabs, 2nd Floor, Golden Plaza, KG 546 St. Kacyiru, Kigali, Rwanda.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baringer', 'Affiliation': 'YLabs, 2nd Floor, Golden Plaza, KG 546 St. Kacyiru, Kigali, Rwanda.'}, {'ForeName': 'Emmyson', 'Initials': 'E', 'LastName': 'Gatare', 'Affiliation': 'YLabs, 2nd Floor, Golden Plaza, KG 546 St. Kacyiru, Kigali, Rwanda.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Umubyeyi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, College of Medicine and Health Sciences, University of Rwanda, P.O. Box: 5229, Kigali, Rwanda.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sayinzoga', 'Affiliation': 'Rwanda Biomedical Center, KG 17 Ave, towards Amahoro Stadium, Remera, Rukiri II, Remera, Gasabo, Kigali, Rwanda.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mugisha', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, College of Medicine and Health Sciences, University of Rwanda, P.O. Box: 5229, Kigali, Rwanda.'}, {'ForeName': 'Janepher', 'Initials': 'J', 'LastName': 'Turatsinze', 'Affiliation': 'Society for Family Health, Rwanda, Plot 99 KG543 St. Kacyiru, PO Box: 3040, Kigali, Rwanda.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Naganza', 'Affiliation': 'Society for Family Health, Rwanda, Plot 99 KG543 St. Kacyiru, PO Box: 3040, Kigali, Rwanda.'}, {'ForeName': 'Laiah', 'Initials': 'L', 'LastName': 'Idelson', 'Affiliation': 'YTH Initiative, ETR, 1630 San Pablo Avenue, Suite 500, Oakland, CA, 94612, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bertozzi', 'Affiliation': 'School of Public Health, University of California, Berkeley, 2121 Berkeley Way West, MC 7360, Berkeley, CA, 94720, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'McCoy', 'Affiliation': 'School of Public Health, University of California, Berkeley, 2121 Berkeley Way West, MC 7360, Berkeley, CA, 94720, USA.'}]",BMC public health,['10.1186/s12889-020-09746-7']
1727,33187502,Peer-led pediatric resuscitation training: effects on self-efficacy and skill performance.,"BACKGROUND


Peer-led basic life support training in medical school may be an effective and valued way of teaching medical students, yet no research has been conducted to evaluate the effect on the self-efficacy of medical students. High self-efficacy stimulates healthcare professionals to initiate and continue basic life support despite challenges.
METHODS


A randomized controlled trial, in which medical students received pediatric basic life support (PBLS) training, provided by either near-peer instructors or expert instructors. The students were randomly assigned to the near-peer instructor group (n = 105) or expert instructor group (n = 108). All students received two hours of PBLS training in groups of approximately 15 students. Directly after this training, self-efficacy was assessed with a newly developed questionnaire, based on a validated scoring tool. A week after each training session, students performed a practical PBLS exam and completed another questionnaire to evaluate skill performance and self-efficacy, respectively.
RESULTS


Students trained by near-peers scored significantly higher on self-efficacy regarding all aspects of PBLS. Theoretical education and instructor feedback were equally valued in both groups. The scores for the practical PBLS exam and the percentage of students passing the exam were similar in both groups.
CONCLUSIONS


Our findings point towards the fact that near-peer-trained medical students can develop a higher level of PBLS-related self-efficacy than expert-trained students, with comparable PBLS skills in both training groups. The exact relationship between peer teaching and self-efficacy and between self-efficacy and the quality of real-life pediatric resuscitation should be further explored.
TRIAL REGISTRATION


ISRCTN, ISRCTN69038759 . Registered December 12th, 2019 - Retrospectively registered.",2020,"The scores for the practical PBLS exam and the percentage of students passing the exam were similar in both groups.
",[],"['Peer-led pediatric resuscitation training', 'pediatric basic life support (PBLS) training, provided by either near-peer instructors or expert instructors', 'near-peer instructor group (n\u2009=\u2009105) or expert instructor group', 'PBLS training']","['self-efficacy', 'self-efficacy and skill performance']",[],"[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0204928', 'cui_str': 'CPR education'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0302911,"The scores for the practical PBLS exam and the percentage of students passing the exam were similar in both groups.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Binkhorst', 'Affiliation': ""Radboud Institute for Health Sciences (RIHS), Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. mathijs.binkhorst@radboudumc.nl.""}, {'ForeName': 'J M Th', 'Initials': 'JMT', 'LastName': 'Draaisma', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Benthem', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'E M R', 'Initials': 'EMR', 'LastName': 'van de Pol', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hogeveen', 'Affiliation': ""Radboud Institute for Health Sciences (RIHS), Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.""}, {'ForeName': 'E C T H', 'Initials': 'ECTH', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",BMC medical education,['10.1186/s12909-020-02359-z']
1728,33187503,Group hypnosis for stress reduction and improved stress coping: a multicenter randomized controlled trial.,"BACKGROUND


The aim of the trial was to investigate the effect of a hypnotherapeutic group program in healthy persons with increased levels of perceived stress.
METHODS


In a randomized controlled multicenter trial participants with a self-assessed subjective stress level ≥ 40 mm on a visual analogue scale (0-100 mm; VAS) for the previous week and a stable state of health were randomized to either 5 weekly sessions of 120-min duration of a hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group). The primary outcome parameter was the VAS stress level for the previous week after 5 weeks. Secondary outcome parameters included the VAS stress level after 12 weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36) after 5 weeks and 12 weeks. Analysis of covariance with a significance level of 5% using the full analysis set was used for analysis; the model included treatment (fixed effect), VAS baseline value (fixed covariate), and center (random effect).
RESULTS


A total of 95 participants were randomized; 47 (40 female, 45 ± 13.4 years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9 ± 14.3 years) were allocated to the control group. Regarding VAS stress level after 5 weeks, the adjusted VAS mean in the hypnosis group was 41.8 mm [95% confidence interval (CI): 35.2; 48.4] compared to 62.9 mm [56.2; 69.7] in the control group, and the group difference was - 21.2 mm [- 30.1; - 12.2] (P < 0.001). After 12 weeks, the stress intensity on the VAS showed a between-group difference of - 14.7 mm [- 25.1; - 4.4] (P = 0.006), and the adjusted means were 41.1 mm [33.4; 48.8] in the hypnosis group and 55.9 mm [48.4; 63.5] in the control group. Improvements were also reported for CPSS, SF-36, SWE and ADS-K after 5 and 12 weeks.
CONCLUSION


Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03525093 ; date of registration: May 15, 2018.",2020,"Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks.
","['participants with a self-assessed subjective stress level\u2009≥\u200940\u2009mm on a visual analogue scale (0-100\u2009mm; VAS) for the previous week and a stable state of health', '95 participants were randomized; 47 (40 female, 45\u2009±\u200913.4\u2009years of age) were allocated to the hypnosis group, and 48 (41 female, 46.9\u2009±\u200914.3\u2009years', 'healthy persons with increased levels of perceived stress']","['hypnotherapeutic group program', 'hypnotherapeutic group program for stress reduction and improved stress coping plus 5 hypnosis audiorecords for individual practice at home plus an educational booklet for stress coping (hypnosis group) versus an educational booklet only (control group']","['VAS stress level', 'CPSS, SF-36, SWE and ADS-K', 'stress intensity on the VAS', 'VAS stress level after 12\u2009weeks, perceived stress (CPSS), depression (ADS-K), self efficacy (SWE) and quality of life (SF 36', 'stress reduction and improved stress coping', 'adjusted VAS mean']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",95.0,0.122995,"Compared to the control group, the hypnosis group showed reduced perceived stress after 5 and 12 weeks.
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Fisch', 'Affiliation': 'Psychotherapeutische Praxis, Daruper Str. 14, 48653, Coesfeld, Germany.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Trivaković-Thiel', 'Affiliation': 'Psychotherapeutische Praxis, Daruper Str. 14, 48653, Coesfeld, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Roll', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité -Universitätsmedizin Berlin, Luisenstr. 57, 10117, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Binting', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité -Universitätsmedizin Berlin, Luisenstr. 57, 10117, Berlin, Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Cree', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité -Universitätsmedizin Berlin, Luisenstr. 57, 10117, Berlin, Germany.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Brinkhaus', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité -Universitätsmedizin Berlin, Luisenstr. 57, 10117, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teut', 'Affiliation': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité -Universitätsmedizin Berlin, Luisenstr. 57, 10117, Berlin, Germany. michael.teut@charite.de.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03129-6']
1729,33187506,Nurse-led advance care planning with older people who have end-stage kidney disease: feasibility of a deferred entry randomised controlled trial incorporating an economic evaluation and mixed methods process evaluation (ACReDiT).,"BACKGROUND


Advance Care Planning is recommended for people with end-stage kidney disease but evidence is limited. Robust clinical trials are needed to investigate the impact of advance care planning in this population. There is little available data on cost-effectiveness to guide decision makers in allocating resources for advance care planning. Therefore we sought to determine the feasibility of a randomised controlled trial and to test methods for assessing cost-effectiveness.
METHODS


A deferred entry, randomised controlled feasibility trial, incorporating economic and process evaluations, with people with end-stage kidney disease, aged 65 years or older, receiving haemodialysis, in two renal haemodialysis units in Northern Ireland, UK. A nurse facilitator helped the patient make an advance care plan identifying: a surrogate decision-maker; what the participant would like to happen in the future; any advance decision to refuse treatment; preferred place of care at end-of-life.
RESULTS


Recruitment lasted 189 days; intervention and data collection 443 days. Of the 67 patients invited to participate 30 (45%) declined and 36 were randomised to immediate or deferred advance care plan groups. Twenty-two (61%) made an advance care plan and completed data collection at 12 weeks; 17 (47.2%) were able to identify a surrogate willing to be named in the advance care plan document. The intervention was well-received and encouraged end-of-life conversations, but did not succeed in helping patients to fully clarify their values or consider specific treatment choices. There was no significant difference in health system costs between the immediate and deferred groups.
CONCLUSIONS


A trial of advance care planning with participants receiving haemodialysis is feasible and acceptable to patients, but challenging. A full trial would require a pool of potential participants five times larger than the number required to complete data collection at 3 months. Widening eligibility criteria to include younger (under 65 years of age) and less frail patients, together with special efforts to engage and retain surrogates may improve recruitment and retention. Traditional advance care planning outcomes may need to be supplemented with those that are defined by patients, helping them to participate with clinicians in making medical decisions.
TRIAL REGISTRATION


Registered December 16, 2015. ClinicalTrials.gov Identifier: NCT02631200 .",2020,"There was no significant difference in health system costs between the immediate and deferred groups.
","['people with end-stage kidney disease', 'Widening eligibility criteria to include younger (under 65\u2009years of age) and less frail patients', 'older people who have end-stage kidney disease', 'people with end-stage kidney disease, aged 65\u2009years or older, receiving haemodialysis, in two renal haemodialysis units in Northern Ireland, UK', '67 patients invited to participate 30 (45%) declined and 36 were randomised to immediate or deferred advance care plan groups']","['Nurse-led advance care planning', 'economic evaluation and mixed methods process evaluation (ACReDiT', 'advance care planning']","['cost-effectiveness', 'health system costs']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C4544311', 'cui_str': 'Advance care plan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",5.0,0.121857,"There was no significant difference in health system costs between the immediate and deferred groups.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK. p.ohalloran@qub.ac.uk.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Noble', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Norwood', 'Affiliation': 'School of Psychology, Ulster University, Cromore Road, Coleraine, Co. Londonderry, BT52 1SA, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Maxwell', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Whitla Medical Building, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Fliss', 'Initials': 'F', 'LastName': 'Murtagh', 'Affiliation': 'Hull York Medical School, University of Hull, Allam Medical Building, Hull, HU6 7RX, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Shields', 'Affiliation': 'Regional Nephrology Unit, Belfast City Hospital, 51 Lisburn Road, Belfast, BT9 7AB, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mullan', 'Affiliation': 'Renal Unit, Antrim Area Hospital, Bush Road, Antrim, BT41 2RL, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cardwell', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, Royal Victoria Hospital, Belfast, BT12 6BA, UK.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, Royal Victoria Hospital, Belfast, BT12 6BA, UK.""}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Morton', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 92-94 Parramatta Rd, Camperdown, NSW, 2050, Australia.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Forbes', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Brazil', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK.""}]",BMC nephrology,['10.1186/s12882-020-02129-5']
1730,33187543,A study protocol for HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine: the HERBAL trial.,"BACKGROUND


Cancer-related fatigue (CRF) is a debilitating condition which commonly affects cancer survivors. The management of CRF remains a challenge due to the lack of effective pharmacological interventions. Traditional Chinese medicine (TCM) could be a potential therapeutic option for CRF. The modified Xiang Bei Yang Rong Tang (XBYRT) is a TCM herbal decoction, formulated to improve fatigue symptoms in cancer survivors. This clinical trial aims to evaluate the efficacy and safety of XBYRT in improving CRF and quality of life (QOL) of cancer survivors.
METHODS


This is a single centre, randomized, double-blind, placebo-controlled, parallel trial. Eighty cancer survivors will be recruited and randomized to receive the XBYRT or placebo decoction, in a ratio of 1:1. Participants will consume the XBYRT/placebo decoction daily for 8 weeks and undergo assessments at baseline and 4, 8 and 10 weeks after baseline. The participants will be assessed for patient-reported outcomes (PRO), blood biomarkers and adverse events at each time point. The primary outcome is the overall health and QOL status, at 8 weeks follow-up. The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO. The incidence of adverse events and the effects of the XBYRT decoction on blood biomarkers associated with CRF will also be evaluated.
DISCUSSION


Efficacy and safety outcomes from this trial will provide important clinical data to guide future large-scale randomized controlled trials, and the evaluation of the objective blood biomarkers can help to delineate the biological mechanisms of CRF.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT04104113 . Registered on 26 September 2019.",2020,"The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO.","['Eighty cancer survivors', 'survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine', 'cancer survivors']","['XBYRT/placebo decoction', 'Traditional Chinese medicine (TCM', 'XBYRT decoction', 'XBYRT or placebo decoction', 'placebo', 'XBYRT', 'modified Xiang Bei Yang Rong Tang (XBYRT']","['overall health and QOL status', 'outcomes (PRO), blood biomarkers and adverse events', 'CRF and quality of life (QOL', 'effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",80.0,0.593183,"The secondary outcomes are the effects of XBYRT on fatigue levels, cancer-related cognitive impairment and QOL, as assessed by PRO.","[{'ForeName': 'Ning Yi', 'Initials': 'NY', 'LastName': 'Yap', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wei Sheng', 'Initials': 'WS', 'LastName': 'Loo', 'Affiliation': 'Department of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Huang Fang', 'Initials': 'HF', 'LastName': 'Zheng', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore, Singapore.'}, {'ForeName': 'Quan Ming', 'Initials': 'QM', 'LastName': 'Tan', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore, Singapore.'}, {'ForeName': 'Tze Kiat', 'Initials': 'TK', 'LastName': 'Tan', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore, Singapore.'}, {'ForeName': 'Leona Yan Peng', 'Initials': 'LYP', 'LastName': 'Quek', 'Affiliation': 'Singapore Thong Chai Medical Institution, Singapore, Singapore.'}, {'ForeName': 'Chia Jie', 'Initials': 'CJ', 'LastName': 'Tan', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Yi Long', 'Initials': 'YL', 'LastName': 'Toh', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Chiu Chin', 'Initials': 'CC', 'LastName': 'Ng', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Seng Kok', 'Initials': 'SK', 'LastName': 'Ang', 'Affiliation': 'Department of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Veronique Kiak Mien', 'Initials': 'VKM', 'LastName': 'Tan', 'Affiliation': 'Division of Surgery & Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Han Kiat', 'Initials': 'HK', 'LastName': 'Ho', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Lita', 'Initials': 'L', 'LastName': 'Chew', 'Affiliation': 'Department of Pharmacy, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Kiley Wei-Jen', 'Initials': 'KW', 'LastName': 'Loh', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Tira Jing Ying', 'Initials': 'TJY', 'LastName': 'Tan', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Department of Pharmacy, National Cancer Centre Singapore, Singapore, Singapore. a.chan@uci.edu.'}]",Trials,['10.1186/s13063-020-04810-4']
1731,33187556,Effect of manual reduction and indirect decompression on thoracolumbar burst fracture: a comparison study.,"OBJECTIVE


To evaluate the effect of manual reduction and indirect decompression on thoracolumbar burst fracture.
METHODS


Sixty patients with thoracolumbar burst fracture who were hospitalized from January 2018 to October 2019 were selected and divided into an experimental group (33 cases) and control group (27 cases) according to different treatment methods. The experimental group was treated with manual reduction and indirect decompression, while the control group was not treated with manual reduction. The operation time and intraoperative blood loss were recorded. VAS score was used to evaluate the improvement of pain. The anterior height of the injured vertebra, wedge angle of the injured vertebral body, and encroachment ratio of the injured vertebral canal were used to evaluate the spinal canal decompression and fracture reduction. JOA score was used to evaluate the improvement of spinal function.
RESULTS


There was no significant difference in operation time and intraoperative blood loss between the two groups. Compared with the control group, the VAS score and the wedge angle of the injured vertebral body of the experimental group 3 days after the operation and the last follow-up were significantly lower than that of the control group, and the difference was statistically significant. The ratio of the anterior height of the injured vertebra of the experimental group 3 days after the operation and the last follow-up was significantly higher than that of the control group, and the difference was statistically significant. The difference of the encroachment ratio of the injured vertebral canal between preoperation and 3 days after operation was significantly higher than that of the control group, and the difference was statistically significant. The bladder function of JOA 3 days after the operation of the experimental group was significantly higher than that of the control group, and the difference was statistically significant. And the rest aspect of JOA on 3 days after the operation and last follow-up of the experimental group has no significant difference compared with the control group.
CONCLUSION


Manipulative reduction and indirect decompression can obtain a better clinical effect in the treatment of thoracolumbar burst fractures.",2020,"The bladder function of JOA 3 days after the operation of the experimental group was significantly higher than that of the control group, and the difference was statistically significant.","['Sixty patients with thoracolumbar burst fracture who were hospitalized from January 2018 to October 2019', 'thoracolumbar burst fractures', 'thoracolumbar burst fracture']","['Manipulative reduction and indirect decompression', 'manual reduction and indirect decompression, while the control group was not treated with manual reduction', 'manual reduction and indirect decompression']","['VAS score and the wedge angle of the injured vertebral body', 'bladder function', 'ratio of the anterior height of the injured vertebra', 'VAS score', 'JOA score', 'operation time and intraoperative blood loss', 'encroachment ratio of the injured vertebral canal', 'spinal canal decompression and fracture reduction', 'improvement of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0185114', 'cui_str': 'Manual reduction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0454239', 'cui_str': 'Wedge angle'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0232840', 'cui_str': 'Bladder function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0157888,"The bladder function of JOA 3 days after the operation of the experimental group was significantly higher than that of the control group, and the difference was statistically significant.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopaedic, Haikou Hospital of Traditional Chinese Medicine, 2 Poxiang Road, Longhua District, Haikou, Hainan Province, People's Republic of China. 67866987@qq.com.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopaedic, Haikou Hospital of Traditional Chinese Medicine, 2 Poxiang Road, Longhua District, Haikou, Hainan Province, People's Republic of China.""}, {'ForeName': 'Zhaodong', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopaedic, Haikou Hospital of Traditional Chinese Medicine, 2 Poxiang Road, Longhua District, Haikou, Hainan Province, People's Republic of China.""}, {'ForeName': 'Zongbo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopaedic, Haikou Hospital of Traditional Chinese Medicine, 2 Poxiang Road, Longhua District, Haikou, Hainan Province, People's Republic of China.""}, {'ForeName': 'Xuejian', 'Initials': 'X', 'LastName': 'Gou', 'Affiliation': ""Department of Orthopaedic, Haikou Hospital of Traditional Chinese Medicine, 2 Poxiang Road, Longhua District, Haikou, Hainan Province, People's Republic of China.""}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-02075-w']
1732,33187563,Endurance and Resistance Respiratory Muscle Training and Aerobic Exercise Performance in Hypobaric Hypoxia.,"INTRODUCTION:  Hypoxia-induced hyperventilation is an effect of acute altitude exposure, which may lead to respiratory muscle fatigue and secondary locomotor muscle fatigue. The purpose of this study was to determine if resistive and/or endurance respiratory muscle training (RRMT and ERMT, respectively) vs. placebo respiratory muscle training (PRMT) improve cycling performance at altitude. METHODS:  There were 24 subjects who were assigned to PRMT ( N  8), RRMT ( N  8), or ERMT ( N  8). Subjects cycled to exhaustion in a hypobaric chamber decompressed to 3657 m (12,000 ft) at an intensity of 55% sea level maximal oxygen consumption (Vo 2max ) before and after respiratory muscle training (RMT). Additionally, subjects completed a Vo 2max , pulmonary function, and respiratory endurance test (RET) before and after RMT. All RMT protocols consisted of three 30-min training sessions per week for 4 wk. RESULTS:  The RRMT group increased maximum inspiratory (P Imax ) and expiratory (P Emax ) mouth pressure after RMT (P Imax : 117.7 11.6 vs. 162.6 20.0; P Emax : 164.0 33.2 vs. 216.5 44.1 cmH₂O). The ERMT group increased RET after RMT (5.2 5.2 vs.18.6 16.9 min). RMT did not improve Vo 2max  in any group. Both RRMT and ERMT groups increased cycling time to exhaustion (RRMT: 35.9 17.2 vs. 45.6 22.2 min and ERMT: 33.8 9.6 vs. 42.9 27.0 min). CONCLUSION:  Despite different improvements in pulmonary function, 4 wk of RRMT and ERMT both improved cycle time to exhaustion at altitude. Wheelock CE, Hess HW, Johnson BD, Schlader ZJ, Clemency BM, St. James E, Hostler D.  Endurance and resistance respiratory muscle training and aerobic exercise performance in hypobaric hypoxia . Aerosp Med Hum Perform. 2020; 91(10):776784.",2020,The RRMT group increased maximum inspiratory (P Imax ) and expiratory (P Emax ) mouth pressure after RMT (P Imax : 117.7 11.6 vs. 162.6 20.0; P Emax : 164.0 33.2 vs. 216.5 44.1 cmH₂O).,"['24 subjects who were assigned to PRMT ( N  8), RRMT ( N  8), or ERMT ( N  8', '2020', 'Hypobaric Hypoxia']","['Hypoxia-induced hyperventilation', 'ERMT', 'resistive and/or endurance respiratory muscle training (RRMT and ERMT, respectively) vs. placebo respiratory muscle training (PRMT', 'RMT', 'intensity of 55% sea level maximal oxygen consumption (Vo 2max ) before and after respiratory muscle training (RMT', 'Endurance and Resistance Respiratory Muscle Training and Aerobic Exercise Performance', 'RRMT and ERMT']","['Vo 2max , pulmonary function, and respiratory endurance test (RET', 'cycling time to exhaustion', 'maximum inspiratory (P Imax ) and expiratory (P Emax ) mouth pressure']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0415731,The RRMT group increased maximum inspiratory (P Imax ) and expiratory (P Emax ) mouth pressure after RMT (P Imax : 117.7 11.6 vs. 162.6 20.0; P Emax : 164.0 33.2 vs. 216.5 44.1 cmH₂O).,"[{'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': ''}, {'ForeName': 'Hayden W', 'Initials': 'HW', 'LastName': 'Hess', 'Affiliation': ''}, {'ForeName': 'Blair D', 'Initials': 'BD', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Zachary J', 'Initials': 'ZJ', 'LastName': 'Schlader', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Clemency', 'Affiliation': ''}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'St James', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hostler', 'Affiliation': ''}]",Aerospace medicine and human performance,['10.3357/AMHP.5624.2020']
1733,33187565,Self-Kinematic Training for Flight-Associated Neck Pain: a Randomized Controlled Trial.,"BACKGROUND:  Flight-associated neck pain (FANP) is a serious problem in fighter pilots. Despite the high impact of FANP there is little evidence for effective management. However, self-kinematic training showed a positive effect in the general population. The purpose of this study was to investigate the effectiveness of a self-kinematic training program using virtual reality in improving neck pain in fighter pilots. METHODS:  There were 45 pilots with FANP who were randomized to a control group ( N  23) or a training group ( N  22). Training participants were instructed to exercise using a personalized self-training program, for 20 min/wk, for 4 wk. Primary outcome measures were neck disability (NDI%) and mean velocity ( s 1 ), and secondary were pain, health status, accuracy, and isometric strength. Assessments were conducted by a blinded assessor and intention-to-treat analysis by a blinded statistician. RESULTS:  There were 40 pilots who completed the postintervention assessments, and 35 completed the 6-mo follow-up. Baseline measurements showed mild pain and disability (mean VAS 43 22.73, NDI 17.76 9.59%) and high kinematic performance. Compliance with self-training was poor. No differences were observed in self-reported measures and strength. Exercise duration was correlated with NDI% improvement. DISCUSSION:  This self-kinematic training promoted kinematic performance, but was ineffective in engaging the pilots to exercise, and consequently did not improve pain and disability. Poor compliance was previously reported in self-training for FANP, suggesting further studies should prioritize supervised training. Considering the high baseline kinematic performance, kinematics does not seem to be a key factor in FANP, and future exercise research should aim for intense strengthening to increase endurance to the high G z  pilots experience. Sarig Bahat H, German D, Palomo G, Gold H, Frankel Nir Y.  Self-kinematic training for flight-associated neck pain: a randomized controlled trial . Aerosp Med Hum Perform. 2020; 91(10):790797.",2020,"Baseline measurements showed mild pain and disability (mean VAS 43 22.73, NDI 17.76 9.59%) and high kinematic performance.","['fighter pilots', 'Flight-Associated Neck Pain', '45 pilots with FANP']","['Sarig Bahat H, German D, Palomo G, Gold H, Frankel Nir Y.  Self-kinematic training', 'Self-Kinematic Training', 'FANP', 'self-kinematic training program']","['high kinematic performance', 'mild pain and disability', 'neck disability (NDI%) and mean velocity ( s 1 ), and secondary were pain, health status, accuracy, and isometric strength', 'pain and disability', 'Exercise duration', 'self-reported measures and strength', 'neck pain']","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",,0.0700144,"Baseline measurements showed mild pain and disability (mean VAS 43 22.73, NDI 17.76 9.59%) and high kinematic performance.","[{'ForeName': 'Hilla Sarig', 'Initials': 'HS', 'LastName': 'Bahat', 'Affiliation': ''}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'German', 'Affiliation': ''}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Palomo', 'Affiliation': ''}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Yael Frankel', 'Initials': 'YF', 'LastName': 'Nir', 'Affiliation': ''}]",Aerospace medicine and human performance,['10.3357/AMHP.5546.2020']
1734,33188050,European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma.,"On the 15 November 2018, the Committee for Medicinal Products for Human Use adopted an extension to an existing indication for the use of nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). The approval was based on results from the Pivotal CA209214 study, a randomised, open-label, phase III study, comparing nivolumab +ipilimumab with sunitinib in subjects≥18 years of age with previously untreated advanced RCC (not amenable for surgery or radiotherapy) or metastatic RCC, with a clear-cell component. A total of 1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either nivolumab (n=425) in combination with ipilimumab administered every 3 weeks for 4 doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks or sunitinib (n=422) administered orally for 4 weeks followed by 2 weeks off, every cycle. A statistically significant difference in overall survival (OS) was observed in the nivolumab + ipilimumab group compared with the sunitinib group in intermediate/poor-risk subjects (HR 0.63 (99.8% CI 0.44 to 0.89); stratified log-rank 2-sided p-value<0.0001). The median OS was not reached for the nivolumab + ipilimumab group and was 25.95 months for the sunitinib group. The OS rates were 89.5% and 86.2% at 6 months, and 80.1% and 72.1% at 12 months in the nivolumab +ipilimumab and the sunitinib groups, respectively. K-M curves separated after approximately 3 months, favouring nivolumab + ipilimumab. This was not mirrored in the favourable-risk patients where no statistically significant difference was observed between nivolumab + ipilimumab and sunitinib in favourable-risk patients (HR 1.45 (descriptive 99.8% CI 0.51 to 4.12), p =0.2715).",2020,The median OS was not reached for the nivolumab + ipilimumab group and was 25.95 months for the sunitinib group.,"['adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC', 'adults with intermediate/poor-risk advanced renal cell carcinoma', '1096 patients were randomised in the trial, of which 847 patients had intermediate/poor-risk RCC and received either', 'in subjects≥18 years of age with previously untreated advanced RCC (not amenable for surgery or radiotherapy) or metastatic RCC, with a clear-cell component']","['nivolumab (n=425) in combination with ipilimumab', 'nivolumab + ipilimumab', 'nivolumab monotherapy 3\u2009mg/kg every 2 weeks or sunitinib', 'nivolumab +ipilimumab with sunitinib', 'nivolumab (Opdivo) and ipilimumab (Yervoy', 'nivolumab (Opdivo) in combination with ipilimumab (Yervoy']","['median OS', 'overall survival (OS', 'OS rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3154308', 'cui_str': 'Yervoy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",1096.0,0.0550273,The median OS was not reached for the nivolumab + ipilimumab group and was 25.95 months for the sunitinib group.,"[{'ForeName': 'Sahra', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'European Medicines Agency, Amsterdam, Netherlands.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Camarero', 'Affiliation': 'Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.'}, {'ForeName': 'Paula van', 'Initials': 'PV', 'LastName': 'Hennik', 'Affiliation': 'Medicines Evaluation Board, Utrecht, Netherlands.'}, {'ForeName': 'Bjorg', 'Initials': 'B', 'LastName': 'Bolstad', 'Affiliation': 'Norwegian Medicines Agency, Oslo, Norway.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Sommerfelt Grønvold', 'Affiliation': 'Norwegian Medicines Agency, Oslo, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Syvertsen', 'Affiliation': 'Norwegian Medicines Agency, Oslo, Norway.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Oddvar Strøm', 'Affiliation': 'Norwegian Medicines Agency, Oslo, Norway.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ökvist', 'Affiliation': 'Norwegian Medicines Agency, Oslo, Norway.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Josephson', 'Affiliation': 'Medical Products Agency, Uppsala, Sweden.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Keller-Stanislawski', 'Affiliation': 'Paul-Ehrlich-Institute, Langen, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Zafiropoulos', 'Affiliation': 'European Medicines Agency, Amsterdam, Netherlands.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Pean', 'Affiliation': 'European Medicines Agency, Amsterdam, Netherlands.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Radiumhemmet Microbiology and Tumorbiology Center, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'da Rocha Dias', 'Affiliation': 'European Medicines Agency, Amsterdam, Netherlands silvy.darochadias@ema.europa.eu.'}, {'ForeName': 'Franscesco', 'Initials': 'F', 'LastName': 'Pignatti', 'Affiliation': 'European Medicines Agency, Amsterdam, Netherlands.'}]",ESMO open,['10.1136/esmoopen-2020-000798']
1735,33188204,Self-perceived cognitive impairments in psychosis ultra-high risk individuals: associations with objective cognitive deficits and functioning.,"There is a scarcity of evidence on subjectively reported cognitive difficulties in individuals at ultra-high risk (UHR) for psychosis and whether these self-perceived cognitive difficulties may relate to objective cognitive deficits, psychopathology, functioning, and adherence to cognitive remediation (CR). Secondary, exploratory analyses to a randomized, clinical trial were conducted with 52 UHR individuals receiving a CR intervention. Participants completed the Measure of Insight into Cognition-Self Report (MIC-SR), a measure of daily life cognitive difficulties within the domains of attention, memory, and executive functions along with measures of neuropsychological test performance, psychopathology, functioning, and quality of life. Our study found participants with and without objectively defined cognitive deficits reported self-perceived cognitive deficits of the same magnitude. No significant relationship was revealed between self-perceived and objectively measured neurocognitive deficits. Self-perceived cognitive deficits associated with attenuated psychotic symptoms, overall functioning, and quality of life, but not with adherence to, or neurocognitive benefits from, a CR intervention. Our findings indicate that UHR individuals may overestimate their cognitive difficulties, and higher levels of self-perceived cognitive deficits may relate to poor functioning. If replicated, this warrants a need for both subjective and objective cognitive assessment in at-risk populations as this may guide psychoeducational approaches and pro-functional interventions. Self-perceived cognitive impairments do not seem to directly influence CR adherence and outcome in UHR states. Further studies are needed on potential mediator between self-perceived cognitive deficits and functioning and quality of life.",2020,"Self-perceived cognitive deficits associated with attenuated psychotic symptoms, overall functioning, and quality of life, but not with adherence to, or neurocognitive benefits from, a CR intervention.","['psychosis ultra-high risk individuals', '52 UHR individuals receiving a CR intervention']",[],"['Measure of Insight into Cognition-Self Report (MIC-SR), a measure of daily life cognitive difficulties within the domains of attention, memory, and executive functions along with measures of neuropsychological test performance, psychopathology, functioning, and quality of life', 'psychotic symptoms, overall functioning, and quality of life', 'self-perceived and objectively measured neurocognitive deficits']","[{'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4552512', 'cui_str': 'Neurocognitive deficit'}]",,0.0470296,"Self-perceived cognitive deficits associated with attenuated psychotic symptoms, overall functioning, and quality of life, but not with adherence to, or neurocognitive benefits from, a CR intervention.","[{'ForeName': 'Louise Birkedal', 'Initials': 'LB', 'LastName': 'Glenthøj', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900, Hellerup, Denmark. louise.birkedal.glenthoej@regionh.dk.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Mariegaard', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Tina Dam', 'Initials': 'TD', 'LastName': 'Kristensen', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wenneberg', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900, Hellerup, Denmark.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Medalia', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, 10032, USA.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Copenhagen Research Centre for Mental Health (CORE), Copenhagen University Hospital, DK-2900, Hellerup, Denmark.'}]",NPJ schizophrenia,['10.1038/s41537-020-00124-1']
1736,33188208,The effect of toxic pyridine-alkaloid secondary metabolites on the sunbird gut microbiome.,"Sunbirds feed on tobacco tree nectar which contains toxic nicotine and anabasine secondary metabolites. Our aim was to understand the effect of nicotine and anabasine on the gut microbiota composition of sunbirds. Sixteen captive sunbirds were randomly assigned to two diets: artificial nectar either with (treatment) or without (control) added nicotine and anabasine. Excreta were collected at 0, 2, 4 and 7 weeks of treatment and samples were processed for bacterial culture and high-throughput amplicon sequencing of the 16S rRNA gene. The gut microbiome diversity of the treated and control birds changed differently along the seven-week experiment. While the diversity decreased in the control group along the first three samplings (0, 2 and 4 weeks), it increased in the treatment group. The microbiota composition analyses demonstrated that a diet with nicotine and anabasine, significantly changed the birds' gut microbiota composition compared to the control birds. The abundance of nicotine- and anabasine- degrading bacteria in the excreta of the treated birds, was significantly higher after four and seven weeks compared to the control group. Furthermore, analysis of culturable isolates, including Lactococcus, showed that sunbirds' gut-associated bacteria were capable of degrading nicotine and anabasine, consistent with their hypothesised role as detoxifying and nutritional symbionts.",2020,"The microbiota composition analyses demonstrated that a diet with nicotine and anabasine, significantly changed the birds' gut microbiota composition compared to the control birds.",['Sixteen captive sunbirds'],"['nicotine and anabasine', 'toxic pyridine-alkaloid secondary metabolites', 'diets: artificial nectar either with (treatment) or without (control) added nicotine and anabasine']","[""birds' gut microbiota composition"", 'abundance of nicotine- and anabasine- degrading bacteria']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0326737', 'cui_str': 'Sunbird'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0002743', 'cui_str': 'Anabasine'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034251', 'cui_str': 'Pyridine'}, {'cui': 'C0002062', 'cui_str': 'Alkaloid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C2717960', 'cui_str': 'Nectar'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0002743', 'cui_str': 'Anabasine'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",,0.0163042,"The microbiota composition analyses demonstrated that a diet with nicotine and anabasine, significantly changed the birds' gut microbiota composition compared to the control birds.","[{'ForeName': 'Mohanraj', 'Initials': 'M', 'LastName': 'Gunasekaran', 'Affiliation': 'Department of Evolutionary and Environmental Biology, Faculty of Natural Sciences, University of Haifa, Mount Carmel, Haifa, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Lalzar', 'Affiliation': 'Bioinformatics Service Unit, University of Haifa, Mount Carmel, Haifa, Israel.'}, {'ForeName': 'Yehonatan', 'Initials': 'Y', 'LastName': 'Sharaby', 'Affiliation': 'Department of Evolutionary and Environmental Biology, Faculty of Natural Sciences, University of Haifa, Mount Carmel, Haifa, Israel.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Izhaki', 'Affiliation': 'Department of Evolutionary and Environmental Biology, Faculty of Natural Sciences, University of Haifa, Mount Carmel, Haifa, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Halpern', 'Affiliation': 'Department of Evolutionary and Environmental Biology, Faculty of Natural Sciences, University of Haifa, Mount Carmel, Haifa, Israel. mhalpern@research.haifa.ac.il.'}]",NPJ biofilms and microbiomes,['10.1038/s41522-020-00161-9']
1737,33188240,Cessation of Bezafibrate in patients with chronic kidney disease improves renal function.,"Bezafibrate (BzF) is eliminated by renal excretion and dosage must be reduced in patients with chronic kidney disease (CKD). There is a concern that BzF causes a further deterioration in renal function in patients with CKD. This study assessed whether BzF discontinuation or dose reduction in CKD patients improves renal function. 117 CKD patients treated with BzF between 2009 and 2014 were studied for demographics, comorbid conditions and laboratory variables. Data compared 2 groups: an intervention group of 64 patients where recommendations regarding BzF administration was implemented and a control group of 37 patients. Follow-up was maintained for 12 months. In the intervention group, estimated glomerular filtration rate (eGFR) increased from 38 to 42 mL/min/1.73 m 2  (p = 0.01); blood urea levels decreased from 81 to 77 mg/dL (p = 0.04). Serum creatinine decreased by more than 0.2 mg/dL in 45% of the intervention group, as compared to 19% of the control group (p < 0.01). Improvement in eGFR was seen exclusively in patients who stopped BzF completely (eGFR increased from 38 to 44 mL/min/1.73 m 2 ). In the intervention group, TG level increased from 183 to 220 mg/dL (p < 0.001). BzF cessation in approximately 50% of patients with CKD was associated with an increase in eGFR.",2020,"In the intervention group, TG level increased from 183 to 220 mg/dL (p < 0.001).","['patients with CKD', 'patients with chronic kidney disease', 'patients with chronic kidney disease (CKD', '117 CKD patients treated with BzF between 2009 and 2014 were studied for demographics, comorbid conditions and laboratory variables']","['Bezafibrate (BzF', 'Bezafibrate']","['renal function', 'eGFR', 'Serum creatinine', 'TG level', 'BzF cessation', 'glomerular filtration rate (eGFR', ' blood urea levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0005330', 'cui_str': 'Bezafibrate'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",117.0,0.0247882,"In the intervention group, TG level increased from 183 to 220 mg/dL (p < 0.001).","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Zingerman', 'Affiliation': 'Community Nephrology Clinic, Clalit Health Services, Kiryat Ono, Israel. borisz@clalit.org.il.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Ziv', 'Affiliation': 'Division of Clinical Pharmacy, Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Netta', 'Initials': 'N', 'LastName': 'Feder Krengel', 'Affiliation': 'Community Nephrology Clinic, Clalit Health Services, Kiryat Ono, Israel.'}, {'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Korzets', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Matok', 'Affiliation': 'Division of Clinical Pharmacy, Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel.'}]",Scientific reports,['10.1038/s41598-020-76861-1']
1738,33175338,The feasibility of mindfulness-based cognitive therapy for people with bipolar disorder: a qualitative study.,"BACKGROUND


Mindfulness- Based Cognitive Therapy (MBCT) could be a promising psychosocial intervention for people with bipolar disorder (BD). However, little is known about the feasibility of MBCT for people with BD. In this study we explore the facilitators and barriers people with BD experience of an adapted MBCT program.
METHOD


This qualitative study is part of a large, multicenter randomized controlled trial on MBCT for BD (trial registration number: NCT03507647). The present study included 16 participants with BD who participated in an 8-week adapted MBCT program. Semi- structured interviews exploring the feasibility, with a particular focus on the bipolar symptoms, were recorded verbatim, transcribed and analyzed. For reasons of triangulation, teachers were interviewed as well.
RESULTS


Participants reported different barriers and facilitators of MBCT, both generally as well as with regard to their bipolar disorder. Four key themes arose: the training itself, psychosocial factors, personal characteristics and the bipolar disorder. Themes were further divided in subthemes.
CONCLUSION


The adapted MBCT program seemed to be feasible for people with BD. Depressive symptoms often acted as a barrier for participating in MBCT, suggesting that participants might need additional support when depressed. Manic symptoms could act both as a barrier and facilitator, suggesting that the occurrence of (hypo)mania does not necessarily have to be an exclusion criterion for participation. Further clinical and research implications are suggested.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03507647. Registered 25th of April 2018, https://clinicaltrials.gov/ct2/show/NCT03507647 .",2020,"RESULTS


Participants reported different barriers and facilitators of MBCT, both generally as well as with regard to their bipolar disorder.","['barriers people with BD experience of an adapted MBCT program', '16 participants with BD who participated in an 8-week adapted MBCT program', 'people with bipolar disorder (BD', 'people with bipolar disorder']","['mindfulness-based cognitive therapy', 'MBCT', 'Cognitive Therapy (MBCT']",['Depressive symptoms'],"[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",16.0,0.0873397,"RESULTS


Participants reported different barriers and facilitators of MBCT, both generally as well as with regard to their bipolar disorder.","[{'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Hanssen', 'Affiliation': 'Radboud University Medical Centre, Department of Psychiatry, Centre for Mindfulness, Postbus 9101, 6500 HB, Nijmegen, The Netherlands. imke.hanssen@radboudumc.nl.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'van der Horst', 'Affiliation': 'Radboud University Medical Centre, Department of Psychiatry, Centre for Mindfulness, Postbus 9101, 6500 HB, Nijmegen, The Netherlands. n.van.der.horst@propersona.nl.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Boele', 'Affiliation': 'Radboud University Medical Centre, Department of Psychiatry, Centre for Mindfulness, Postbus 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lochmann van Bennekom', 'Affiliation': 'Pro Persona Institute for Mental Health Care, Outpatient Clinic for Bipolar Disorders, Tarweweg 2, 6534 AM, Nijmegen, The Netherlands.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Regeer', 'Affiliation': 'Altecht Institute for Mental Health Care, Outpatient Clinic for Bipolar Disorder, Lange Nieuwstraat 119, 3512 PG, Utrecht, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Speckens', 'Affiliation': 'Radboud University Medical Centre, Department of Psychiatry, Centre for Mindfulness, Postbus 9101, 6500 HB, Nijmegen, The Netherlands.'}]",International journal of bipolar disorders,['10.1186/s40345-020-00197-y']
1739,33170863,"Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial.","BACKGROUND


Dolutegravir (DTG)-based dual therapy is becoming a new paradigm for both the initiation and maintenance of HIV treatment. The SIMPL'HIV study investigated the outcomes of virologically suppressed patients on standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC). We present the 48-week efficacy and safety data on DTG + FTC versus cART.
METHODS AND FINDINGS


SIMPL'HIV was a multicenter, open-label, non-inferiority randomized trial with a factorial design among treatment-experienced people with HIV in Switzerland. Participants were enrolled between 12 May 2017 and 30 May 2018. Patients virologically suppressed for at least 24 weeks on standard cART were randomized 1:1 to switching to DTG + FTC or to continuing cART, and 1:1 to simplified patient-centered monitoring versus standard monitoring. The primary endpoint was the proportion of patients virologically suppressed with <100 copies/ml through 48 weeks. The secondary endpoints included virological suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis. Non-inferiority of DTG + FTC versus cART for viral suppression was assessed using a stratified Mantel-Haenszel risk difference, with non-inferiority declared if the lower bound of the 95% confidence interval was greater than -12%. Adverse events were monitored to assess safety. Quality of life was evaluated using the PROQOL-HIV questionnaire. Ninety-three participants were randomized to DTG + FTC, and 94 individuals to cART. Median nadir CD4 count was 246 cells/mm3; median age was 48 years; 17% of participants were female. DTG + FTC was non-inferior to cART. The proportion of patients with viral suppression (<100 copies/ml) through 48 weeks was 93.5% in the DTG + FTC arm and 94.7% in the cART arm in the intention-to-treat population (risk difference -1.2%; 95% CI -7.8% to 5.6%). Per-protocol analysis showed similar results, with viral suppression in 96.5% of patients in both arms (risk difference 0.0%; 95% CI -5.6% to 5.5%). There was no relevant interaction between the type of treatment and monitoring (interaction ratio 0.98; 95% CI 0.85 to 1.13; p = 0.81). Using the FDA snapshot algorithm, 84/93 (90.3%) participants in the DTG + FTC arm had an HIV-1 RNA viral load of <50 copies/ml compared to 86/94 (91.5%) participants on standard cART (risk difference -1.1%; 95% CI -9.3% to 7.1%; p = 0.791). The overall proportion of patients with adverse events and discontinuations did not differ by randomization arm. The proportion of patients with serious adverse events was higher in the cART arm (16%) compared to the DTG + FTC arm (6.5%) (p = 0.041), but none was considered to be related to the study medication. Quality of life improved more between baseline and week 48 in the DTG + FTC compared to the cART arm (adjusted difference +2.6; 95% CI +0.4 to +4.7). The study's main limitations included a rather small proportion of women included, the open label design, and its short duration.
CONCLUSIONS


In this study, DTG + FTC as maintenance therapy was non-inferior to cART in terms of efficacy, with a similar safety profile and a greater improvement in quality of life, thus expanding the offer of 2-drug simplification options among virologically suppressed individuals.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03160105.",2020,Quality of life improved more between baseline and week 48 in the DTG + FTC compared to the cART arm (adjusted difference +2.6; 95% CI +0.4 to +4.7).,"['Patients virologically suppressed for at least 24 weeks on standard cART', 'Ninety-three participants were randomized to', 'treatment-experienced people with HIV in Switzerland', 'Participants were enrolled between 12 May 2017 and 30 May 2018']","['dolutegravir plus emtricitabine', 'cART', 'DTG + FTC', 'standard combination antiretroviral therapy (cART) switching to DTG + emtricitabine (FTC', 'Dolutegravir (DTG)-based dual therapy']","['proportion of patients with viral suppression', 'overall proportion of patients with adverse events and discontinuations', 'proportion of patients with serious adverse events', 'Adverse events', 'viral suppression', 'Median nadir CD4 count', 'HIV-1 RNA viral load', 'Efficacy and safety', 'proportion of patients virologically suppressed', 'Quality of life', 'quality of life', 'virological suppression at 48 weeks according to the US Food and Drug Administration (FDA) snapshot analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",93.0,0.255481,Quality of life improved more between baseline and week 48 in the DTG + FTC compared to the cART arm (adjusted difference +2.6; 95% CI +0.4 to +4.7).,"[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Sculier', 'Affiliation': 'HIV/AIDS Unit, Department of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Wandeler', 'Affiliation': 'Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Yerly', 'Affiliation': 'Laboratory of Virology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Marinosci', 'Affiliation': 'HIV/AIDS Unit, Department of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Stoeckle', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel, University of Basel, Switzerland.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Service of Infectious Diseases, Lugano Regional Hospital, Lugano, Switzerland.'}, {'ForeName': 'Dominique L', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Vernazza', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Cavassini', 'Affiliation': 'Department of Infectious Diseases, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Buzzi', 'Affiliation': 'HIV/AIDS Unit, Department of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Metzner', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Laurent A', 'Initials': 'LA', 'LastName': 'Decosterd', 'Affiliation': 'Pharmacology Laboratory, Clinical Pharmacology Department, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Huldrych F', 'Initials': 'HF', 'LastName': 'Günthard', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Egger', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'HIV/AIDS Unit, Department of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003421']
1740,33170877,Effectiveness of a decision aid for colorectal cancer screening on components of informed choice according to educational attainment: A randomised controlled trial.,"BACKGROUND


The decision to take up colorectal cancer screening has to be made on informed grounds balancing benefits and harms. Self-administered decision aids can support citizens in making an informed choice. A self-administered web-based decision aid targeting citizens with lower educational attainment has been evaluated within the target population. However, the effectiveness in the general screening population remains unexplored. The aim of this study was to evaluate the effectiveness of a web-based decision aid for colorectal cancer screening on components of informed choice among previous non-participants in colorectal cancer screening.
METHODS AND FINDINGS


The study was designed as a parallel randomised controlled trial among non-participants in colorectal cancer screening in Central Denmark Region (men and women aged 53-74 years). Respondents to baseline and follow-up questionnaires comprised the study population (n = 1,723). The intervention group received the decision aid electronically along with the second reminder. The control group received only the second reminder. The main outcomes (knowledge, attitudes, uptake and decisional conflict) were obtained through questionnaires data and from the Danish Colorectal Cancer Screening Database. The decision aid increased the uptake rate by 8 percentage points (95% CI: 3.4;12.6) but had no effect on either knowledge (scale score differences: 0.09; 95% CI: -0.05;0.24) or attitudes (0.45; 95% CI: -0.00;0.91). Decisional conflict decreased by 1.69 scale points (95% CI: -3.18;-0.20). The effect was similar across educational attainment levels.
CONCLUSIONS


The web-based decision aid offers a feasible way to provide individualised screening information in a ""one size fits all"" approach that may hold the potential to increase informed CRC screening uptake.
TRIAL REGISTRATION


ClinicalTrials.gov registration number: NCT03253888.",2020,The decision aid increased the uptake rate by 8 percentage points (95% CI: 3.4;12.6) but had no effect on either knowledge (scale score differences: 0.09; 95% CI: -0.05;0.24) or attitudes (0.45; 95% CI: -0.00;0.91).,"['previous non-participants in colorectal cancer screening', 'non-participants in colorectal cancer screening in Central Denmark Region (men and women aged 53-74 years']","['decision aid for colorectal cancer screening', 'web-based decision aid for colorectal cancer screening', 'decision aid electronically along with the second reminder']","['uptake rate', 'Decisional conflict', 'main outcomes (knowledge, attitudes, uptake and decisional conflict']","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",1723.0,0.286779,The decision aid increased the uptake rate by 8 percentage points (95% CI: 3.4;12.6) but had no effect on either knowledge (scale score differences: 0.09; 95% CI: -0.05;0.24) or attitudes (0.45; 95% CI: -0.00;0.91).,"[{'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Gabel', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Mette Bach', 'Initials': 'MB', 'LastName': 'Larsen', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kirkegaard', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Andersen', 'Affiliation': 'Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark.'}]",PloS one,['10.1371/journal.pone.0241703']
1741,33170908,Identification of a 6-gene signature for the survival prediction of breast cancer patients based on integrated multi-omics data analysis.,"PURPOSE


To identify a gene signature for the prognosis of breast cancer using high-throughput analysis.
METHODS


RNASeq, single nucleotide polymorphism (SNP), copy number variation (CNV) data and clinical follow-up information were downloaded from The Cancer Genome Atlas (TCGA), and randomly divided into training set or verification set. Genes related to breast cancer prognosis and differentially expressed genes (DEGs) with CNV or SNP were screened from training set, then integrated together for feature selection of identify robust biomarkers using RandomForest. Finally, a gene-related prognostic model was established and its performance was verified in TCGA test set, Gene Expression Omnibus (GEO) validation set and breast cancer subtypes.
RESULTS


A total of 2287 prognosis-related genes, 131 genes with amplified copy numbers, 724 gens with copy number deletions, and 280 genes with significant mutations screened from Genomic Variants were closely correlated with the development of breast cancer. A total of 120 candidate genes were obtained by integrating genes from Genomic Variants and those related to prognosis, then 6 characteristic genes (CD24, PRRG1, IQSEC3, MRGPRX, RCC2, and CASP8) were top-ranked by RandomForest for feature selection, noticeably, several of these have been previously reported to be associated with the progression of breast cancer. Cox regression analysis was performed to establish a 6-gene signature, which can stratify the risk of samples from training set, test set and external validation set, moreover, the five-year survival AUC of the model in the training set and validation set was both higher than 0.65. Thus, the 6-gene signature developed in the current study could serve as an independent prognostic factor for breast cancer patients.
CONCLUSION


This study constructed a 6-gene signature as a novel prognostic marker for predicting the survival of breast cancer patients, providing new diagnostic/prognostic biomarkers and therapeutic targets for breast cancer patients.",2020,"Cox regression analysis was performed to establish a 6-gene signature, which can stratify the risk of samples from training set, test set and external validation set, moreover, the five-year survival AUC of the model in the training set and validation set was both higher than 0.65.","['A total of 2287 prognosis-related genes, 131 genes with amplified copy numbers, 724 gens with copy number deletions, and 280 genes with significant mutations screened from Genomic Variants', 'breast cancer patients']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],2287.0,0.0187389,"Cox regression analysis was performed to establish a 6-gene signature, which can stratify the risk of samples from training set, test set and external validation set, moreover, the five-year survival AUC of the model in the training set and validation set was both higher than 0.65.","[{'ForeName': 'Wenju', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': 'The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Zou', 'Affiliation': 'The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences, Beijing, China.'}]",PloS one,['10.1371/journal.pone.0241924']
1742,33176129,A Nasal High-Flow System Prevents Upper Airway Obstruction and Hypoxia in Pediatric Dental Patients Under Intravenous Sedation.,"PURPOSE


Upper airway obstruction (UAO) and oxygen desaturation are risk factors for major complications of intravenous sedation (IVS) in pediatric dental patients. This study aimed to investigate the use of a nasal high-flow (NHF) system for the prevention of UAO and oxygen desaturation in pediatric dental patients under IVS.
METHODS


The authors implemented a prospective randomized design. Thirty pediatric patients (aged 3 to 12), scheduled for dental treatment under IVS, were enrolled in this study. The subjects were randomly assigned to 1 of 2 groups: patients who received oxygen at 5 L/minute through a nasal cannula (NC group) and patients who received oxygen at 2 kg/L/minute, up to a maximum of 30 L/minute, through the NHF system (NHF group). The predictor variable was flow rate. The primary outcome variable was the need for intervention during treatment, and the secondary outcome variable was the lowest peripheral capillary oxygen saturation values during the procedure. Additional study variables measured included patient age, gender, weight, height, and surgical duration. The Mann-Whitney U test and Fisher exact test were used for statistical analysis, with P < .05 considered as significant.
RESULTS


Both the NC (n = 15; mean age, 6.2 ± 2.3) and NHF (n = 15; mean age, 5.9 ± 2.5) groups had a male:female ratio of 2:1. The use of the NHF system significantly improved the lowest peripheral capillary oxygen saturation values during treatment (P < .05). Jaw lifting, to relieve UAO and facilitate spontaneous breathing, was required in both the NC (n = 10) and NHF (n = 3) groups (P < .05). The need for interventions during treatment was significantly lower in the NHF group (P < .05).
CONCLUSIONS


The results of this study suggest that the use of the NHF system can prevent UAO and improve the respiratory condition of pediatric dental patients under IVS.",2020,The use of the NHF system significantly improved the lowest peripheral capillary oxygen saturation values during treatment (P < .05).,"['n\xa0=\xa015; mean age, 6.2\xa0±\xa02.3) and NHF (n\xa0=\xa015; mean age, 5.9\xa0±\xa02.5) groups had a male:female ratio of 2:1', 'pediatric dental patients under IVS', 'Thirty pediatric patients (aged 3 to 12), scheduled for dental treatment under IVS', 'Pediatric Dental Patients Under Intravenous Sedation', 'pediatric dental patients']","['Nasal High-Flow System', 'intravenous sedation (IVS', 'oxygen at 5\xa0L/minute through a nasal cannula (NC group) and patients who received oxygen at 2\xa0kg/L/minute, up to a maximum of 30\xa0L/minute, through the NHF system (NHF group', 'nasal high-flow (NHF) system', 'NC']","['UAO and oxygen desaturation', 'lowest peripheral capillary oxygen saturation values']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1300565', 'cui_str': 'g/cm3'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",30.0,0.0677934,The use of the NHF system significantly improved the lowest peripheral capillary oxygen saturation values during treatment (P < .05).,"[{'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Sago', 'Affiliation': 'Assistant Professor, Division of Dental Anesthesiology, Department of Science of Physical Functions, Kyushu Dental University, Fukuoka, Japan. Electronic address: r07sagou@fa.kyu-dent.ac.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Lecturer, Division of Developmental Stomatognathic Function Science, Department of Health Promotion, Kyushu Dental University, Fukuoka, Japan.'}, {'ForeName': 'Kazune', 'Initials': 'K', 'LastName': 'Kawabata', 'Affiliation': 'Graduate Student, Division of Dental Anesthesiology, Department of Science of Physical Functions, Kyushu Dental University, Fukuoka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Shiiba', 'Affiliation': 'Associate Professor, Division of Dental Anesthesiology, Department of Science of Physical Functions, Kyushu Dental University, Fukuoka, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Maki', 'Affiliation': 'Professor, Division of Developmental Stomatognathic Function Science, Department of Health Promotion, Kyushu Dental University, Fukuoka, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Professor, Division of Dental Anesthesiology, Department of Science of Physical Functions, Kyushu Dental University, Fukuoka, Japan.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.10.018']
1743,33176460,Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy: The COAPT Trial.,"BACKGROUND


In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT.
METHODS


Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use.
RESULTS


Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%,  P =0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42-0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39-0.69]; adjusted  P interaction =0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted  P interaction =0.14) and HF hospitalization (adjusted  P interaction =0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity.
CONCLUSIONS


In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.",2020,"Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%,  P =0.32).","['patients enrolled in COAPT', 'Patients With and', 'Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the', 'patients with previously', '614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively', 'Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT']","['CRT', 'TMVr', 'implanted cardiac resynchronization therapy (CRT', 'MitraClip Percutaneous Therapy', 'MitraClip', 'MitraClip (TMVr arm) versus GDMT', 'Transcatheter Mitral Valve Repair', 'MitraClip plus guideline-directed medical therapy (GDMT', 'Cardiac Resynchronization Therapy']","['2-year rates of the composite of death or HF hospitalization', '2-year rates of all-cause death', 'Death or HF hospitalization', 'quality-of-life and exercise capacity', 'HF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C2921039', 'cui_str': 'Transcatheter mitral valve repair'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",614.0,0.134835,"Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%,  P =0.32).","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, TN (J.L.).'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus (W.T.A., K.D.B.).'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.).'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, University of Virginia, Charlottesville (D.S.L.).'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Mishell', 'Affiliation': 'Kaiser Permanente-San Francisco Hospital, CA (J.M.M.).'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Whisenant', 'Affiliation': 'Intermountain Heart Center, Salt Lake City, UT (B.K.W.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kipperman', 'Affiliation': 'Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (R.M.K.).'}, {'ForeName': 'Konstantinos D', 'Initials': 'KD', 'LastName': 'Boudoulas', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus (W.T.A., K.D.B.).'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott and White Health, Plano, TX (M.J.M.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (I.K., B.R., B.S., Z.Z., G.W.S.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.007293']
1744,33176462,Cause of Death Among Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.,"BACKGROUND


Peripheral artery disease is common and associated with high mortality. There are limited data detailing causes of death among patients with peripheral artery disease.
METHODS


EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) was a randomized clinical trial that assigned patients with peripheral artery disease to clopidogrel or ticagrelor. We describe the causes of death in EUCLID using mortality end points adjudicated through a clinical events classification process. The association between baseline factors and cardiovascular death was evaluated by Cox proportional hazards modeling. The competing risk of noncardiovascular death was assessed by the cumulative incidence function for cardiovascular death and the Fine and Gray method to ascertain the association between baseline characteristics and cardiovascular mortality.
RESULTS


A total of 1263 out of 13 885 (9.1%) patients died (median follow-up: 30 months). There were 706 patients (55.9%) with a cardiovascular cause of death and 522 (41.3%) with a noncardiovascular cause of death. The most common cause of cardiovascular death was sudden cardiac death (20.1%); while myocardial infarction (5.2%) and ischemic stroke (3.2%) were uncommon. The most common causes of noncardiovascular death were malignancies (17.9%) and infections (11.9%). The factor most associated with a higher risk of cardiovascular death was age per 5 year increase (HR, 1.26 [95% CI, 1.20-1.32]). Female sex was associated with a lower risk of cardiovascular death (HR, 0.68 [95% CI, 0.56-0.82]). To evaluate the effect of noncardiovascular death as a competing risk, we superimposed the cumulative incidence function curve with the Kaplan-Meier curve. These curves closely approximated each other. After accounting for the competing risk of noncardiovascular death, the magnitude and direction of the factors associated with cardiovascular death were minimally changed.
CONCLUSIONS


Among patients with symptomatic peripheral artery disease, noncardiovascular causes of death reflected a high proportion (40%) of deaths. Accounting for noncardiovascular deaths as a competing risk, there was not a significant change in the risk estimation for cardiovascular death. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.",2020,"Female sex was associated with a lower risk of cardiovascular death (HR, 0.68","['Patients With Peripheral Artery Disease', 'patients with peripheral artery disease', 'EUCLID', 'Peripheral Artery Disease', '706 patients (55.9%) with a cardiovascular cause of death and 522 (41.3%) with a noncardiovascular cause of death', 'patients with peripheral artery disease to', 'patients with symptomatic peripheral artery disease, noncardiovascular causes of death reflected a high proportion (40%) of deaths']","['Ticagrelor', 'clopidogrel or ticagrelor']","['cardiovascular death was sudden cardiac death', 'noncardiovascular deaths', 'myocardial infarction', 'Cause of Death', 'ischemic stroke', 'noncardiovascular death', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",13885.0,0.242571,"Female sex was associated with a lower risk of cardiovascular death (HR, 0.68","[{'ForeName': 'Ajar', 'Initials': 'A', 'LastName': 'Kochar', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (A.K.).""}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute (H.M., F.W.R., R.D.L., H.R.A.-K., M.R.P.), Duke University, Durham, NC.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute (H.M., F.W.R., R.D.L., H.R.A.-K., M.R.P.), Duke University, Durham, NC.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Departments of Medicine and Surgery, New York University School of Medicine (J.S.B.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Heart Centre, Turku University Hospital, Finland (J.I.B.).'}, {'ForeName': 'F Gerry R', 'Initials': 'FGR', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.R.F.).'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Gaithersburg, MD (B.G.K.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Heart Center, Division of Cardiology, School of Medicine (R.D.L., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute (H.M., F.W.R., R.D.L., H.R.A.-K., M.R.P.), Duke University, Durham, NC.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, Örebro University, Sweden (L.N.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke Heart Center, Division of Cardiology, School of Medicine (R.D.L., M.R.P., W.S.J.), Duke University, Durham, NC.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Heart Center, Division of Cardiology, School of Medicine (R.D.L., M.R.P., W.S.J.), Duke University, Durham, NC.'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006550']
1745,33177129,"Modification of diet, exercise and lifestyle (MODEL) study: a randomised controlled trial protocol.","INTRODUCTION


Most cardiovascular disease (CVD)-related events could be prevented or substantially delayed with improved diet and lifestyle. Providing information on structural vascular disease may improve CVD risk factor management, but its impact on lifestyle change remains unclear. This study aims to determine whether providing visualisation and pictorial representation of structural vascular disease (abdominal aortic calcification (AAC)) can result in healthful diet and lifestyle change.
METHODS AND ANALYSIS


This study, including men and women aged 60-80 years, is a 12-week, two-arm, multisite randomised controlled trial. At baseline, all participants will have AAC assessed from a lateral spine image captured using a bone densitometer. Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks. All participants will receive information about routinely assessed CVD risk factors and standardised (video) diet and lifestyle advice with three simple goals: (1) increase fruit and vegetable (FV) intake by at least one serve per day, (2) improve other aspects of the diet and (3) reduce sitting time and increase physical activity. Clinical assessments will be performed at baseline and 12 weeks.
OUTCOMES


The primary outcome is a change in serum carotenoid concentrations as an objective measure of FV intake. The study design, procedures and treatment of data will adhere to Standard Protocol Items for Randomized Trials guidelines.
ETHICS AND DISSEMINATION


Ethics approval for this study has been granted by the Edith Cowan University and the Deakin University Human Research Ethics Committees (Project Numbers: 20513 HODGSON and 2019-220, respectively). Results of this study will be published in peer-reviewed academic journals and presented in scientific meetings and conferences. Information regarding consent, confidentiality, access to data, ancillary and post-trial care and dissemination policy has been disclosed in the participant information form.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trial Registry (ACTRN12618001087246).",2020,Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks.,"['men and women aged 60-80 years', 'Edith Cowan University and the Deakin University Human Research Ethics Committees (Project Numbers']","['usual care control', 'visualisation and pictorial representation of structural vascular disease (abdominal aortic calcification (AAC', 'information about routinely assessed CVD risk factors and standardised (video) diet and lifestyle advice with three simple goals: (1) increase fruit and vegetable (FV) intake']","['sitting time and increase physical activity', 'change in serum carotenoid concentrations as an objective measure of FV intake']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",,0.223844,Participants will then be randomised to receive their AAC results at baseline (intervention group) or a usual care control group that will receive their results at 12 weeks.,"[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Radavelli-Bagatini', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia simoneradavelli@hotmail.com.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Blekkenhorst', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Reindolf', 'Initials': 'R', 'LastName': 'Anokye', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Connolly', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schousboe', 'Affiliation': 'Park Nicollet Osteoporosis Center and Health Partners Institute, and Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Szulc', 'Affiliation': 'INSERM UMR 1033, University of Lyon, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'Faculty of Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dimmock', 'Affiliation': 'Department of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Markus P', 'Initials': 'MP', 'LastName': 'Schlaich', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Kiel', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Stanley', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Thompson', 'Affiliation': 'Department of Cardiology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Melbourne, VIC, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'De Ross', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Melbourne, VIC, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Melbourne, VIC, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036366']
1746,33177130,"Implementation, mechanisms of impact and key contextual factors involved in outcomes of the Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation.","INTRODUCTION


The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on 'healthful' improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.
METHODS AND ANALYSIS


The overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing 'healthful' behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.
ETHICS AND DISSEMINATION


The MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.
TRIAL REGISTRATION NUMBER


ACTRN12618001087246.",2020,"The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on 'healthful' improvements to diet and lifestyle.","['200 participants enrolled in the trial', 'Australian adults']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],200.0,0.0814313,"The Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on 'healthful' improvements to diet and lifestyle.","[{'ForeName': 'Reindolf', 'Initials': 'R', 'LastName': 'Anokye', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia ranokye@our.ecu.edu.au.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Radavelli-Bagatini', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sim', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Blekkenhorst', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Connolly', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Nicola P', 'Initials': 'NP', 'LastName': 'Bondonno', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schousboe', 'Affiliation': 'Park Nicollet Osteoporosis Center and Health Partners Institute and Division of Health Policy and Management, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Woodman', 'Affiliation': 'Flinders Centre for Epidemiology and Biostatistics, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Szulc', 'Affiliation': 'INSERM UMR1033, University of Lyon, Lyon, France.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dimmock', 'Affiliation': 'Department of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Markus P', 'Initials': 'MP', 'LastName': 'Schlaich', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Douglas P', 'Initials': 'DP', 'LastName': 'Kiel', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Medical School, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Thompson', 'Affiliation': 'Department of Cardiology, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'De Ross', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Science, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Stanley', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-036395']
1747,33181634,Effects of milrinone on cerebral perfusion and postoperative cognitive function in spine surgery: Secondary analysis of a CONSORT-compliant randomized controlled trial.,"OBJECTIVE


To compare the effects of milrinone, sodium nitroprusside (SNP), and nitroglycerin (NTG) on induced hypotension, cerebral perfusion, and postoperative cognitive function in elderly patients undergoing spine surgery.
METHODS


Sixty patients >60 years scheduled for lumbar fusion surgery were assigned to receive milrinone (group M), SNP (group S), or NTG (group N). The administration of the study drug was initiated immediately after perivertebral muscle retraction and was stopped after completion of interbody fusion. Target blood pressure was a decrease of 30% in systolic blood pressure from baseline or mean blood pressure of 60 to 65 mm Hg. The regional cerebral venous oxygen saturation (rSVO2), as a measure of cerebral perfusion, and the change in perioperative Mini-Mental State Examination (MMSE) score, as a measure of postoperative cognitive function, were assessed.
RESULTS


During the administration of the study drug, the overall and lowest intraoperative rSVO2 values were significantly higher (P = .01 and P = .01, respectively), and the duration of rSVO2 <60% was shorter in group M than in the other groups (P = .03). In group M, intraoperative rSVO2 was not different from the basal value, whereas in groups S and N, rSVO2 was significantly lower than the basal value during the administration of the study drug, but then returned to the basal value after terminating the study drug. Basal MMSE scores were comparable among the 3 groups. The MMSE score on postoperative day 5 was higher in group M than the other groups.
CONCLUSIONS


Milrinone used to induce hypotension resulted in better intraoperative cerebral perfusion and postoperative cognitive function compared to SNP and nitroglycerin.",2020,"The MMSE score on postoperative day 5 was higher in group M than the other groups.
","['elderly patients undergoing spine surgery', 'Sixty patients >60 years scheduled for lumbar fusion surgery', 'spine surgery']","['SNP (group S), or NTG', 'nitroglycerin', 'Milrinone', 'milrinone, sodium nitroprusside (SNP), and nitroglycerin (NTG', 'milrinone']","['overall and lowest intraoperative rSVO2 values', 'perioperative Mini-Mental State Examination (MMSE) score', 'regional cerebral venous oxygen saturation (rSVO2', 'Target blood pressure', 'induced hypotension, cerebral perfusion, and postoperative cognitive function', 'cerebral perfusion and postoperative cognitive function', 'Basal MMSE scores', 'duration of rSVO2', 'systolic blood pressure', 'intraoperative rSVO2', 'intraoperative cerebral perfusion and postoperative cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0428176', 'cui_str': 'Venous oxygen saturation measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0991606,"The MMSE score on postoperative day 5 was higher in group M than the other groups.
","[{'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Department of Anesthesia and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Huh', 'Affiliation': ''}, {'ForeName': 'Jungmin', 'Initials': 'J', 'LastName': 'Koo', 'Affiliation': ''}, {'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Wonjung', 'Initials': 'W', 'LastName': 'Hwang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021717']
1748,33181641,Cognitive-behavioural reflective training for improving critical thinking disposition of nursing students.,"BACKGROUND/OBJECTIVE


The importance of critical thinking in improving treatment practices in, for instance, the nursing profession, cannot be overemphasized. Despite this importance, empirical studies have shown that helping strategies to train learners on critical thinking disposition are needed. Given this knowledge gap, this study investigated the impacts of cognitive-behavioral reflective training for improving the critical thinking disposition of nursing students.
METHOD


Of all the students screened, a total of 167 participants were assigned to the treatment group and waitlisted control group. A researchers-developed training program aimed at improving critical thinking disposition was delivered in English language by therapists.
RESULTS


Repeated-measures ANOVA showed that there was no significant difference between the critical thinking disposition of nursing students in the treatment and control groups as measured by CTDI-M at the posttest. At the posttreatment and follow-up measures, there were consistently improved impacts of CBRT on the critical thinking disposition of nursing students in Nigeria as measured by CTDI-M.
CONCLUSION


Following the results, we concluded that cognitive-behavioral reflective training was beneficial and had sustained improvement in enhancing the critical thinking disposition of nursing students.",2020,"At the posttreatment and follow-up measures, there were consistently improved impacts of CBRT on the critical thinking disposition of nursing students in Nigeria as measured by CTDI-M.
CONCLUSION


Following the results, we concluded that cognitive-behavioral reflective training was beneficial and had sustained improvement in enhancing the critical thinking disposition of nursing students.","['Of all the students screened, a total of 167 participants were assigned to the treatment group and waitlisted control group', 'nursing students']","['Cognitive-behavioural reflective training', 'CBRT', 'cognitive-behavioral reflective training']",['critical thinking disposition of nursing students'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]",167.0,0.0170281,"At the posttreatment and follow-up measures, there were consistently improved impacts of CBRT on the critical thinking disposition of nursing students in Nigeria as measured by CTDI-M.
CONCLUSION


Following the results, we concluded that cognitive-behavioral reflective training was beneficial and had sustained improvement in enhancing the critical thinking disposition of nursing students.","[{'ForeName': 'Godwin C', 'Initials': 'GC', 'LastName': 'Abiogu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Agah', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Felix O', 'Initials': 'FO', 'LastName': 'Ugwuozor', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Maduka', 'Initials': 'M', 'LastName': 'Nweke', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Nneka', 'Initials': 'N', 'LastName': 'Nwosu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Ogechi', 'Initials': 'O', 'LastName': 'Nnamani', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Nkiru E', 'Initials': 'NE', 'LastName': 'Obande-Ogbuinya', 'Affiliation': 'Department of Physiology, Faculty of Basic Medical Sciences, College of Medicine, University of Nigeria, Ituku Ozalla Enugu Campus.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Ogheneakoke', 'Affiliation': 'Department of Science Education (Physical and Health Educations Unit), Faculty of Education, Alex Ekwueme Federal University, Ndufu-Alike Ebonyi State.'}, {'ForeName': 'Uchenna C', 'Initials': 'UC', 'LastName': 'Ugwu', 'Affiliation': 'Department of Social Science Education, Delta State University, Abraka, Delta State.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ujah', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Francis O', 'Initials': 'FO', 'LastName': 'Ekwueme', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Phil', 'Affiliation': 'Department of Human Kinetics and Health Educations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Emmanuel I', 'Initials': 'EI', 'LastName': 'Obeagu', 'Affiliation': 'Department of Philosophy, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'Department of Medical Laboratory Science, Imo State University, Owerri, Imo State, Nigeria.'}, {'ForeName': 'Damian C', 'Initials': 'DC', 'LastName': 'Ncheke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}]",Medicine,['10.1097/MD.0000000000022429']
1749,33181643,Efficacy and safety of different doses of ropivacaine for laparoscopy-assisted infiltration analgesia in patients undergoing laparoscopic cholecystectomy: A prospective randomized control trial.,"BACKGROUND


Wound infiltration analgesia provides effective postoperative pain control in patients undergoing laparoscopic cholecystectomy (LC). However, the efficacy and safety of wound infiltration with different doses of ropivacaine is not well defined. This study investigated the analgesic effects and pharmacokinetic profile of varying concentrations of ropivacaine at port sites under laparoscopy assistance.
METHODS


In this randomized, double-blinded study, 132 patients were assigned to 4 groups: Group H: in which patients were infiltrated with 0.75% ropivacaine; Group M: 0.5% ropivacaine; Group L: 0.2% ropivacaine; and Group C: 0.9% normal saline only. The primary outcome was pain intensity estimated using numeric rating scale (NRS) at discharging from PACU and at 4 hours, 6 hours, 8 hours, and 24 hours after infiltration. Secondary outcomes included plasma concentrations of ropivacaine at 30 minutes after wound infiltration, rescue analgesia requirements after surgery, perioperative vital signs changes, and side effects.
RESULTS


The NRS in Group C was significantly higher at rest, and when coughing upon leaving PACU and at 4 hours, 6 hours, 8 hours, and 24 hours after infiltration (P < .05) and rescue analgesic consumption was significantly higher. Notably, these parameters were not significantly different between Groups H, Group M and Group L (P > .05). Intra-operative consumption of sevoflurane and remifentanil, HR at skin incision and MAP at skin incision, as well as 5 minutes after skin incision were significantly higher in Group C than in the other 3 groups (P < .01). In contrast, these parameters were not significantly different between Groups H, Group M and Group L (P > .05). The concentration of ropivacaine at 30 minutes after infiltration in Group H was significantly higher than that of Group L and Group M (P < .05). No significant differences were observed in the occurrence of side effects among the 4 groups (P > .05).
CONCLUSIONS


Laparoscopy-assisted wound infiltration with ropivacaine successfully decreases pain intensity in patients undergoing LC regardless of the doses used. Infiltration with higher doses results in higher plasma concentrations, but below the systematic toxicity threshold.",2020,"Notably, these parameters were not significantly different between Groups H, Group M and Group L","['patients undergoing laparoscopic cholecystectomy', '132 patients', 'patients undergoing laparoscopic cholecystectomy (LC']","['laparoscopy-assisted infiltration analgesia', 'ropivacaine', 'sevoflurane and remifentanil, HR at skin incision and MAP at skin incision']","['pain intensity estimated using numeric rating scale (NRS', 'concentration of ropivacaine', 'plasma concentrations of ropivacaine at 30\u200aminutes after wound infiltration, rescue analgesia requirements after surgery, perioperative vital signs changes, and side effects', 'pain intensity', 'Efficacy and safety', 'efficacy and safety of wound infiltration', 'occurrence of side effects', 'rescue analgesic consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",132.0,0.115279,"Notably, these parameters were not significantly different between Groups H, Group M and Group L","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesia, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Yijiao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesia, Liaocheng People's Hospital, Liaocheng, PR China.""}, {'ForeName': 'Dachun', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesia, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou.'}]",Medicine,['10.1097/MD.0000000000022540']
1750,33181655,"The effect of comprehensive assessment and multi-disciplinary management for the geriatric and frail patient: A multi-center, randomized, parallel controlled trial.","BACKGROUND


A comprehensive geriatric assessment (CGA) of elderly patients is useful for detecting the patients vulnerabilities. Exercise and early rehabilitation, nutritional intervention, traditional Chinese medicine (TCM), standardized medication guidance, and patient education can, separately, improve and even reverse the physical frailty status. However, the effect of combining a CGA and multi-disciplinary management on frailty in elderly patients remains unclear. The present study assessed the effects of a CGA and multi-disciplinary management on elderly patients with frailty in China.
METHODS


In this study, 320 in patients with frailty ≥70 years old will be randomly divided into an intervention group and a control group. The intervention group will be given routine management, a CGA and multi-disciplinary management involving rehabilitation exercise, diet adjustment, multi-drug evaluation, acupoint massage in TCM and patient education for 12 months, and the control group will be followed up with routine management for basic diseases. The primary outcomes are the Fried phenotype and short physical performance battery (SPPB). The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL), 5-level European quality of life 5 dimensions index (EQ-5D), nutrition risk screening-2002 (NRS-2002), medical insurance expenses, fall events, and all-cause mortality. In addition, a cost-effectiveness study will be carried out.
DISCUSSION


This paper outlines the protocol for a randomized, single-blind, parallel multi-center clinical study. This protocol, if beneficial, will demonstrate the interaction of various intervention strategies, will help improve elderly frailty patients, and will be useful for clinicians, nurses, policymakers, public health authorities, and the general population.
TRIAL REGISTRATION


Chinese Clinical Trials Register, ChiCTR1900022623. Registered on April 19, 2019, http://www.chictr.org.cn/showproj.aspx?proj=38141.",2020,"The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL),","['geriatric and frail patient', 'elderly patients', '320 in patients with frailty ≥70 years old', 'elderly patients with frailty in China', 'elderly frailty patients']","['routine management, a CGA and multi-disciplinary management involving rehabilitation exercise, diet adjustment, multi-drug evaluation, acupoint massage in TCM and patient education for 12 months, and the control group will be followed up with routine management for basic diseases', 'comprehensive assessment and multi-disciplinary management', 'CGA and multi-disciplinary management', 'Exercise and early rehabilitation, nutritional intervention, traditional Chinese medicine (TCM), standardized medication guidance, and patient education']","['Fried phenotype and short physical performance battery (SPPB', 'clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL', '5-level European quality of life 5 dimensions index (EQ-5D), nutrition risk screening-2002 (NRS-2002), medical insurance expenses, fall events, and all-cause mortality']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",320.0,0.0516481,"The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL),","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Pharmacy.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutriology.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of TCM, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, PR China.'}, {'ForeName': 'Yuhao', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Jiefu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}]",Medicine,['10.1097/MD.0000000000022873']
1751,33186393,Repeated Wingate sprints is a feasible high-quality training strategy in moderate hypoxia.,"Sprint-interval training (SIT) is efficient at improving maximal aerobic capacity and anaerobic fitness at sea-level and may be a feasible training strategy at altitude. Here, it was evaluated if SIT intensity can be maintained in mild to moderate hypoxia. It was hypothesized that 6 x 30 s Wingate sprint performance with 2 min active rest between sprints can be performed in hypoxic conditions corresponding to ~3,000 m of altitude without reducing mean power output (MPO). In a single-blinded, randomized crossover design, ten highly-trained male endurance athletes with a maximal oxygen uptake ([Formula: see text]O2max) of 68 ± 5 mL O2 × min-1 × kg-1 completed 6 x 30 s all-out Wingate cycling sprints separated by two-minute active recovery on four separate days in a hypobaric chamber. The ambient pressure within the chamber on each experimental day was 772 mmHg (~0 m), 679 mmHg (~915 m), 585 mmHg (~ 2,150 m), and 522 mmHg (~3,050 m), respectively. MPO was not different at sea-level and up to ~2,150 m (~1% and ~3% non-significant decrements at ~915 and ~2,150 m, respectively), whereas MPO was ~5% lower (P<0.05) at ~3,050 m. Temporal differences between altitudes was not different for peak power output (PPO), despite a main effect of altitude. In conclusion, repeated Wingate exercise can be completed by highly-trained athletes at altitudes up to ~2,150 m without compromising MPO or PPO. In contrast, MPO was compromised in hypobaric hypoxia corresponding to ~3,050 m. Thus, SIT may be an efficient strategy for athletes sojourning to moderate altitude and aiming to maintain training quality.",2020,"Temporal differences between altitudes was not different for peak power output (PPO), despite a main effect of altitude.","['ten highly-trained male endurance athletes with a maximal oxygen uptake ([Formula: see text]O2max) of 68 ±', 'moderate hypoxia']","['Sprint-interval training (SIT', '5 mL O2 × min-1 × kg-1 completed 6 x 30 s all-out']","['mean power output (MPO', 'hypobaric hypoxia', 'peak power output (PPO', 'ambient pressure', 'MPO']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0205204,"Temporal differences between altitudes was not different for peak power output (PPO), despite a main effect of altitude.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Breenfeldt Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bonne', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels Vidiendal', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': 'Department of Neuroscience and Pharmacology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0242439']
1752,33186396,"Moderate aerobic exercise, but not anticipation of exercise, improves cognitive control.","BACKGROUND


Evidence suggests a single bout of exercise can improve cognitive control. However, many studies only include assessments after exercise. It is unclear whether exercise changes as a result, or in anticipation, of exercise.
OBJECTIVE


To examine changes in cognitive control due to moderate aerobic exercise, and anticipation of such exercise.
METHODS


Thirty-one young healthy adults (mean age 22 years; 55% women) completed three conditions (randomized order): 1) exercise (participants anticipated and completed exercise); 2) anticipation (participants anticipated exercise but completed rest); and 3) rest (participants anticipated and completed rest). Cognitive control was assessed with a modified Flanker task at three timepoints: (1) early (20 min pre-intervention, pre-reveal in anticipation session); (2) pre-intervention (after reveal); and (3) post-intervention. An accuracy-weighted response time (RTLISAS) was the primary outcome, analyzed with a linear mixed effects modeling approach.
RESULTS


There was an interaction between condition and time (p = 0.003) and between session and time (p = 0.015). RTLISAS was better post-exercise than post-rest and post-deception, but was similar across conditions at other timepoints. RTLISAS improved across time in session 1 and session 2, but did not improve over time in session 3. There were also main effects of condition (p = 0.024), session (p = 0.005), time (p<0.001), and congruency (p<0.001).
CONCLUSIONS


Cognitive control improved after moderate aerobic exercise, but not in anticipation of exercise. Improvements on a Flanker task were also observed across sessions and time, indicative of a learning effect that should be considered in study design and analyses.",2020,"RTLISAS was better post-exercise than post-rest and post-deception, but was similar across conditions at other timepoints.","['mean age 22 years; 55% women) completed three conditions (randomized order', 'Thirty-one young healthy adults ']","['Moderate aerobic exercise', '1) exercise (participants anticipated and completed exercise); 2) anticipation (participants anticipated exercise but completed rest); and 3) rest (participants anticipated and completed rest']","['accuracy-weighted response time (RTLISAS', 'cognitive control', 'Cognitive control']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",31.0,0.0966498,"RTLISAS was better post-exercise than post-rest and post-deception, but was similar across conditions at other timepoints.","[{'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Bergelt', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Fung Yuan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Middleton', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Wellington', 'Initials': 'W', 'LastName': 'Martins Dos Santos', 'Affiliation': 'Department of Physical Education, University of Campinas, Campinas, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0242270']
1753,33186411,Acute effect of tendon vibration applied during isometric contraction at two knee angles on maximal knee extension force production.,"The aim of the current study was to investigate the effect of a single session of prolonged tendon vibration combined with low submaximal isometric contraction on maximal motor performance. Thirty-two young sedentary adults were assigned into two groups that differed based on the knee angle tested: 90° or 150° (180° = full knee extension). Participants performed two fatigue-inducing exercise protocols: one with three 10 min submaximal (10% of maximal voluntary contraction) knee extensor contractions and patellar tendon vibration (80 Hz) another with submaximal knee extensor contractions only. Before and after each fatigue protocol, maximal voluntary isometric contractions (MVC), voluntary activation level (assessed by the twitch interpolation technique), peak-to-peak amplitude of maximum compound action potentials of vastus medialis and vastus lateralis (assessed by electromyography with the use of electrical nerve stimulation), peak twitch amplitude and peak doublet force were measured. The knee extensor fatigue was significantly (P<0.05) greater in the 90° knee angle group (-20.6% MVC force, P<0.05) than the 150° knee angle group (-8.3% MVC force, P = 0.062). Both peripheral and central alterations could explain the reduction in MVC force at 90° knee angle. However, tendon vibration added to isometric contraction did not exacerbate the reduction in MVC force. These results clearly demonstrate that acute infrapatellar tendon vibration using a commercial apparatus operating at optimal conditions (i.e. contracted and stretched muscle) does not appear to induce knee extensor neuromuscular fatigue in young sedentary subjects.",2020,"The knee extensor fatigue was significantly (P<0.05) greater in the 90° knee angle group (-20.6% MVC force, P<0.05) than the 150° knee angle group (-8.3% MVC force, P = 0.062).","['Thirty-two young sedentary adults', 'young sedentary subjects']","['three 10 min submaximal (10% of maximal voluntary contraction) knee extensor contractions and patellar tendon vibration (80 Hz) another with submaximal knee extensor contractions only', 'prolonged tendon vibration combined with low submaximal isometric contraction', 'tendon vibration']","['maximal voluntary isometric contractions (MVC), voluntary activation level (assessed by the twitch interpolation technique), peak-to-peak amplitude of maximum compound action potentials of vastus medialis and vastus lateralis (assessed by electromyography with the use of electrical nerve stimulation), peak twitch amplitude and peak doublet force', 'knee extensor neuromuscular fatigue', 'knee extensor fatigue', 'maximal motor performance', 'MVC force']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",32.0,0.0234023,"The knee extensor fatigue was significantly (P<0.05) greater in the 90° knee angle group (-20.6% MVC force, P<0.05) than the 150° knee angle group (-8.3% MVC force, P = 0.062).","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Harnie', 'Affiliation': 'Laboratoire Motricité, Interactions, Performance EA 4334, Faculty of Sport Sciences, University of Nantes, Nantes, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cattagni', 'Affiliation': 'Laboratoire Motricité, Interactions, Performance EA 4334, Faculty of Sport Sciences, University of Nantes, Nantes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Cornu', 'Affiliation': 'Laboratoire Motricité, Interactions, Performance EA 4334, Faculty of Sport Sciences, University of Nantes, Nantes, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McNair', 'Affiliation': 'Health and Rehabilitation Research Institute, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Jubeau', 'Affiliation': 'Laboratoire Motricité, Interactions, Performance EA 4334, Faculty of Sport Sciences, University of Nantes, Nantes, France.'}]",PloS one,['10.1371/journal.pone.0242324']
1754,33186858,Quality of life with adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected stage II-IIIA (N1-N2) EGFR-mutant non-small-cell lung cancer: Results from the ADJUVANT (CTONG1104) study.,"OBJECTIVES


Health-related quality of life (HRQoL) data complement conventional clinical endpoints when comparing adjuvant gefitinib with chemotherapy in patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations. This study aimed to assess changes in HRQoL with adjuvant gefitinib vs chemotherapy in this patient group.
MATERIALS AND METHODS


In the phase III ADJUVANT trial, patients with completely resected, stage II-IIIA (N1-N2), EGFR-mutant NSCLC were randomized (1:1) to receive either gefitinib for 24 months or vinorelbine plus cisplatin (VP) every 3 weeks for four cycles. HRQoL was assessed as a secondary endpoint using the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS) questionnaires, and Trial Outcome Index (TOI) composite score. HRQoL dynamics, improvements, and time to deterioration were compared between groups.
RESULTS


At baseline, 104 of 106, and 80 of 87 patients receiving gefitinib and VP, respectively, completed two questionnaires (FACT-L and LCSS). Baseline scores were balanced between groups. Although HRQoL fluctuated and gradually improved in both groups, longitudinally higher scores were reported with gefitinib than VP (FACT-L, odds ratio 418.16, 95 % confidence interval [CI] 2.75-63509.05, p =  0.019; LCSS, 1.13, 1.04-1.22, p =  0.003; TOI, 88.39, 4.40-1775.05, p =  0.003). Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p =  0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p =  0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p =  0.001).
CONCLUSION


Adjuvant gefitinib is associated with improved HRQoL over VP, supporting its use in patients with stage II-IIIA (N1-N2), EGFR-mutant NSCLC.",2020,"Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p =  0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p =  0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p =  0.001).
","['patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations', 'patients with completely resected, stage II-IIIA (N1-N2), EGFR-mutant', 'patients with completely resected stage II-IIIA (N1-N2) EGFR-mutant non-small-cell lung cancer', 'patients with stage II-IIIA (N1-N2), EGFR-mutant NSCLC']","['gefitinib vs chemotherapy', 'adjuvant gefitinib versus vinorelbine plus cisplatin', 'gefitinib with chemotherapy', 'Adjuvant gefitinib', 'gefitinib', 'vinorelbine plus cisplatin (VP']","['HRQoL', 'Quality of life', 'Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS) questionnaires, and Trial Outcome Index (TOI) composite score', 'HRQoL dynamics, improvements, and time to deterioration', 'Time to deterioration in HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.335678,"Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p =  0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p =  0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p =  0.001).
","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China. Electronic address: maowm@zjcc.org.cn.'}, {'ForeName': 'Qi-Xun', 'Initials': 'QX', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Tao-Bo', 'Initials': 'TB', 'LastName': 'Luo', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Department of Pulmonary Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary Medicine, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Yong-Yu', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, Jilin Provincial Tumor Hospital, Changchun, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, The People's Hospital of Peking University, Beijing, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, Tangdu Hospital, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Pulmonary Oncology, Fujian Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Dong', 'Initials': 'ZD', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Shi-Dong', 'Initials': 'SD', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lun-Xu', 'Initials': 'LX', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Bu-Hai', 'Initials': 'BH', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, The Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Ma', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Suzhou University, Suzhou, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.027']
1755,33186890,Prediction of cancer-specific survival and overall survival in middle-aged and older patients with rectal adenocarcinoma using a nomogram model.,"OBJECTIVE


To develop a new nomogram tool for predicting survival in middle-aged and elderly patients with rectal adenocarcinoma.
METHODS


A total of 6,116 patients were randomly assigned in a 7:3 ratio to training and validation cohorts. Univariate and multivariate Cox proportional hazards regression analyses were used to identify independent prognostic factors associated with overall survival (OS) and cancer-specific survival (CSS) in the training set, and two nomogram prognostic models were constructed. The validity, accuracy, discrimination, predictive ability, and clinical utility of the models were assessed based on the concordance index (C-index), area under the receiver operating characteristics (ROC) curve, time-dependent area under the ROC curve (AUC), Kaplan-Meier survival curve, and decision curve analyses.
RESULTS


Predictors of OS and CSS were identified, and nomograms were successfully constructed. The calibration discrimination for both the OS and CSS nomogram prediction models was good (C-index: 0.763 and 0.787, respectively). The AUC showed excellent predictive performance, and the calibration curve exhibited significant predictive power for both nomograms. The time-dependent AUC showed that the predictive ability of the predictor-based nomogram was better than that of the TNM stage. The nomograms successfully discriminated high-, medium-, and low-risk patients for all-cause and cancer-specific mortality. The decision curve demonstrated that the nomograms are useful with respect to good decision power.
CONCLUSION


Our nomogram survival prediction models may aid in evaluating the prognosis of middle-aged and older patients with rectal adenocarcinoma and guiding the selection of the clinical treatment measures.",2020,"The calibration discrimination for both the OS and CSS nomogram prediction models was good (C-index: 0.763 and 0.787, respectively).","['6,116 patients', 'middle-aged and older patients with rectal adenocarcinoma', 'middle-aged and older patients with rectal adenocarcinoma using a nomogram model', 'middle-aged and elderly patients with rectal adenocarcinoma']",[],"['validity, accuracy, discrimination, predictive ability, and clinical utility', 'overall survival (OS) and cancer-specific survival (CSS', 'concordance index (C-index), area under the receiver operating characteristics (ROC) curve, time-dependent area under the ROC curve (AUC), Kaplan-Meier survival curve, and decision curve analyses', 'cancer-specific survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",6116.0,0.053162,"The calibration discrimination for both the OS and CSS nomogram prediction models was good (C-index: 0.763 and 0.787, respectively).","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Yidan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Rheumatology and Immunology Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ziweng', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Junjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Dasen', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'General Surgery Department, Zaozhuang Municipal Hospital, Qingdao, Shandong, China.'}, {'ForeName': 'Hexiang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Radiology Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. Electronic address: 18661808669@126.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. Electronic address: drjianzhang@126.com.'}]",Translational oncology,['10.1016/j.tranon.2020.100938']
1756,33187116,Long-Term Effects of a Cognitive Behavioral Conference Call Intervention on Depression in Non-Professional Caregivers.,"Recent evidence supports the efficacy of conference call cognitive-behavioral interventions in preventing depression in caregivers at post-intervention, but we do not know whether the results are sustained long term. The main objective of this study was to evaluate the long-term efficacy of a cognitive-behavioral intervention administered by telephone conference call in preventing depression in caregivers with elevated depressive symptoms, comparing all components of the intervention versus only the behavioral ones. A randomized controlled trial was conducted using a dismantling strategy. At total of 219 caregivers were randomly assigned to a cognitive-behavioral conference call intervention (CBCC;  n  = 69), a behavioral-activation conference call intervention (BACC;  n  = 70), or a usual care control group (CG,  n  = 80). Information was collected on depressive symptoms and depression at pre-intervention and at 1, 3, 6, 12, and 36 months post-intervention. At 36 months, there was a reduction in depressive symptoms ( p  < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively). The results show that a conference call intervention was effective in the long term to prevent depression in caregivers and that the behavioral-activation component was comparable to the complete cognitive-behavioral protocol.",2020,"At 36 months, there was a reduction in depressive symptoms ( p  < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively).","['Non-Professional Caregivers', 'caregivers with elevated depressive symptoms', 'At total of 219 caregivers']","['cognitive-behavioral conference call intervention (CBCC;  n  = 69), a behavioral-activation conference call intervention (BACC;  n  = 70), or a usual care control', 'cognitive-behavioral intervention administered by telephone conference call', 'conference call cognitive-behavioral interventions', 'Cognitive Behavioral Conference Call Intervention']","['major depressive episodes', 'depressive symptoms']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",219.0,0.0452861,"At 36 months, there was a reduction in depressive symptoms ( p  < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Lopez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela J', 'Initials': 'ÁJ', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, 15008 A Coruña, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': 'Department of Evolutionary and Educational Psychology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Díaz', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Páramo', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228329']
1757,33187167,Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial.,"Introduction : Neck pain is a condition with a high incidence in primary care. Patients with chronic neck pain often experience reduction in neck mobility. However, no study to date has investigated the effects of manual mobilization of the upper cervical spine in patients with chronic mechanical neck pain and restricted upper cervical rotation.  Objective : To evaluate the effect of adding an upper cervical translatoric mobilization or an inhibitory suboccipital technique to a conventional physical therapy protocol in patients with chronic neck pain test on disability and cervical range of motion.  Design : Randomized controlled trial.  Methods : Seventy-eight patients with chronic neck pain and restricted upper cervical rotation were randomized in three groups: Upper cervical translatoric mobilization group, inhibitory suboccipital technique group, or control group. The neck disability index, active cervical mobility, and the flexion-rotation test were assessed at baseline (T0), after the treatment (T1), and at three-month follow-up (T2).  Results : There were no statistically significant differences between groups in neck disability index. The upper cervical translatoric mobilization group showed a significant increase in the flexion-rotation test to the more restricted side at T1 (F = 5.992;  p  < 0.004) and T2 (F = 5.212;  p  < 0.007) compared to the control group. The inhibitory suboccipital technique group showed a significant increase in the flexion-rotation test to the less restricted side at T1 (F = 3.590;  p  < 0.027). All groups presented high percentages of negative flexion-rotation tests. (T1: 69.2% upper neck translator mobilization group; 38.5% suboccipital inhibition technique group, 19.2% control group; at T2: 80.8%; 46.2% and 26.9% respectively). No significant differences in the active cervical mobility were found between groups. Conclusion: Adding manual therapy to a conventional physical therapy protocol for the upper cervical spine increased the flexion-rotation test in the short- and mid-term in patients with chronic neck pain. No changes were found in the neck disability index and the global active cervical range of motion.",2020,The upper cervical translatoric mobilization group showed a significant increase in the flexion-rotation test to the more restricted side at T1 (F = 5.992;  p  < 0.004) and T2 (F = 5.212;  ,"['Methods : Seventy-eight patients with chronic neck pain and restricted upper cervical rotation', 'patients with chronic mechanical neck pain and restricted upper cervical rotation', 'patients with chronic neck pain test on disability and cervical range of motion', 'Patients with chronic neck pain often experience reduction in neck mobility', 'patients with chronic neck pain']","['conventional physical therapy protocol', 'Upper cervical translatoric mobilization group, inhibitory suboccipital technique group, or control group', 'upper cervical translatoric mobilization or an inhibitory suboccipital technique to a conventional physical therapy protocol']","['Neck pain', 'neck disability index and the global active cervical range of motion', 'neck disability index, active cervical mobility, and the flexion-rotation test', 'active cervical mobility', 'negative flexion-rotation tests', 'neck disability index', 'flexion-rotation test']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",78.0,0.0387853,The upper cervical translatoric mobilization group showed a significant increase in the flexion-rotation test to the more restricted side at T1 (F = 5.992;  p  < 0.004) and T2 (F = 5.212;  ,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'González-Rueda', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo-García', 'Affiliation': 'Facultad de Ciencias de la Salud, Unidad de Investigación en Fisioterapia, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bueno-Gracia', 'Affiliation': 'Facultad de Ciencias de la Salud, Unidad de Investigación en Fisioterapia, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pérez-Bellmunt', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'Pere Ramón', 'Initials': 'PR', 'LastName': 'Rodríguez-Rubio', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228334']
1758,33187261,Efficacy and Safety of Combined Extracts of  Cornus officinalis  and  Ribes fasciculatum  for Body Fat Reduction in Overweight Women.,"Obesity is a medical condition that presents excessive fat accumulation with high risk of serious chronic diseases. The aim of this clinical trial is to investigate the anti-obesity effects of  Cornus officinalis  (CO) and  Ribes fasciculatum  (RF) on body fat reduction in Korean overweight women. A total of 147 overweight female participants enrolled in double-blinded clinical trial for 12 weeks and 76 participants completed the clinical study. Participants were treated with four CO and RF mixture (COEC; 400 mg per tablet) or four placebo tablets once a day. Obesity associated parameters (body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, body fat percentage and body fat mass) and safety assessment were analyzed. After 12 weeks of COEC treatment, primary outcomes such as body fat percentage (0.76% vs. 0.01%;  p  = 0.022) and mass (1.1 kg vs. 0.5 kg;  p  = 0.049) were significantly decreased. In addition, the results were statistically significant between the COEC and placebo groups, strongly indicated that COEC had anti-obesity effects on overweight women. Secondary outcomes-including body weight, waist and hip circumference, waist-to-hip ratio, body mass index and computed tomography measurement of visceral fat area, subcutaneous fat area, total abdominal fat area and visceral-to-subcutaneous fat ratio-were reduced in COEC-treated group, but no statistical differences were found between the COEC and placebo groups. The safety assessment did not differ between the two groups. These results suggest that treatment of COEC extract reduces body fat percentage and mass in Korean overweight women, indicating it as a protective functional agent for obesity.",2020,The safety assessment did not differ between the two groups.,"['Korean overweight women', 'Overweight Women', '147 overweight female participants enrolled in double-blinded clinical trial for 12 weeks and 76 participants completed the clinical study']","['COEC', 'COEC extract', 'placebo tablets', 'CO and RF mixture (COEC', 'Combined Extracts of  Cornus officinalis  and  Ribes fasciculatum', 'Cornus officinalis  (CO) and  Ribes fasciculatum  (RF']","['body fat percentage', 'Obesity associated parameters (body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, body fat percentage and body fat mass) and safety assessment', 'body weight, waist and hip circumference, waist-to-hip ratio, body mass index and computed tomography measurement of visceral fat area, subcutaneous fat area, total abdominal fat area and visceral-to-subcutaneous fat ratio']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0950010', 'cui_str': 'Cornus'}, {'cui': 'C1080864', 'cui_str': 'Currants'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",147.0,0.0458033,The safety assessment did not differ between the two groups.,"[{'ForeName': 'Eunkuk', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Chang Gun', 'Initials': 'CG', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jeonghyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jae-Heon', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, Korea.'}, {'ForeName': 'Young Gyu', 'Initials': 'YG', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul 04551, Korea.'}, {'ForeName': 'Seon-Yong', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9113629']
1759,33187361,"Effect of an Olive Vegetation Water Phenolic Extract on the Physico-Chemical, Microbiological and Sensory Traits of Shrimp ( Parapenaeus longirostris ) during the Shelf-Life.","The aim of this study was to evaluate the effects of phenolic extract derived from olive vegetation water (PEOVW) in deep-water rose shrimps ( Parapenaeus longirostris ) at the day of packaging (D0) and after three (D3), six (D6) and eight (D8) days of refrigerated storage. Freshly caught shrimps were randomly divided into four groups: the phenolic extract (PE) group (2 g/L of phenols); the sulfites (S) group (0.5% sodium metabisulfite solution); the phenolic extract + sulfites (PE + S) group (0.25% sodium metabisulfite solution with 1 g/L of phenols), and the control (CTRL) group (tap water). Concerning color coordinates, there were no variations either between groups or over time, while it is important to highlight that phenolic extract (PE group) led to a significant reduction in total volatile basic nitrogen (TVB-N;  p  < 0.001) and thiobarbituric reactive substances (TBARS;  p  < 0.001) values. Furthermore, PE also had a relevant effect in reducing bacterial counts and decreasing the microbial development. Finally, as concerns melanosis, the effect of phenolic extract alone was marginal, but when combined with half a dose of sodium metabisulfite, it was as effective as the shrimps treated with only sodium metabisulfite in delaying black spots ( p  < 0.05). These results are very promising with a view to commercializing additive-free shrimps.",2020,"Concerning color coordinates, there were no variations either between groups or over time, while it is important to highlight that phenolic extract (PE group) led to a significant reduction in total volatile basic nitrogen (TVB-N;  p  < 0.001) and thiobarbituric reactive substances (TBARS;  p  < 0.001) values.",['Freshly caught shrimps'],"['Olive Vegetation Water Phenolic Extract', 'phenolic extract (PE) group (2 g/L of phenols); the sulfites (S) group (0.5% sodium metabisulfite solution); the phenolic extract + sulfites (PE + S) group (0.25% sodium metabisulfite solution with 1 g/L of phenols), and the control (CTRL', 'phenolic extract derived from olive vegetation water (PEOVW', 'phenolic extract']","['Physico-Chemical, Microbiological and Sensory Traits of Shrimp ( Parapenaeus longirostris ', 'thiobarbituric reactive substances', 'total volatile basic nitrogen', 'bacterial counts']","[{'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0457931', 'cui_str': 'Shrimp'}]","[{'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C1285498', 'cui_str': 'Vegetation'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0038750', 'cui_str': 'Sulfite salt'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0457931', 'cui_str': 'Shrimp'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",,0.0223254,"Concerning color coordinates, there were no variations either between groups or over time, while it is important to highlight that phenolic extract (PE group) led to a significant reduction in total volatile basic nitrogen (TVB-N;  p  < 0.001) and thiobarbituric reactive substances (TBARS;  p  < 0.001) values.","[{'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Miraglia', 'Affiliation': 'Department of Veterinary Medicine, University of Perugia, Via San Costanzo 4, 06126 Perugia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Castrica', 'Affiliation': 'Department of Health, Animal Science and Food Safety ""Carlo Cantoni"", Università degli Studi di Milano, Via Celoria 10, 20133 Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Menchetti', 'Affiliation': 'Department of Agricultural and Agri-Food Sciences and Technologies, University of Bologna, Viale Fanin 46, 40138 Bologna, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Esposto', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Branciari', 'Affiliation': 'Department of Veterinary Medicine, University of Perugia, Via San Costanzo 4, 06126 Perugia, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ranucci', 'Affiliation': 'Department of Veterinary Medicine, University of Perugia, Via San Costanzo 4, 06126 Perugia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Urbani', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Sordini', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Veneziani', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Servili', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}]","Foods (Basel, Switzerland)",['10.3390/foods9111647']
1760,33192057,Long-Term Effects of Pedometer-Based Physical Activity Coaching in Severe COPD: A Randomized Controlled Trial.,"Background and Objective


Limited evidence on long-term effects of physical activity programs in COPD is available. The aim of the study was to investigate the effects of a three-month program combining physical activity counselling and pedometer-based feedback in addition to usual care, followed by a nine-month unsupervised observation period as compared to usual care in participants with severe to very severe COPD.
Methods


Participants were randomized to either a control group receiving usual care or an intervention group receiving motivational support, an activity diary with an individual step count goal (ie, an increase of ≥15% from baseline) and a pedometer in addition to usual care. The intervention ended after three months and an unsupervised observational period followed until twelve months. Primary outcome was daily step count after one year.
Results


Seventy-four participants were included, 61 (82%) completed the study. Linear regression modelling, adjusted for baseline step count, showed no significant difference in change in step count after 12 months between the groups (Β = 547.33, 95% CI = -243.55/1338.20).
Conclusion


A three-month program combining physical activity counselling and pedometer-based feedback in addition to usual care does not attenuate the declining course of physical activity in participants with severe and very severe COPD during a long term follow-up of one year as compared to usual care. This result was primarily determined by the low intervention response rates to the combined program.
Clinical Trial Registration


www.ClinicalTrials.gov, NCT03114241.",2020,"Linear regression modelling, adjusted for baseline step count, showed no significant difference in change in step count after 12 months between the groups (Β = 547.33, 95% CI = -243.55/1338.20).
","['Severe COPD', 'Seventy-four participants were included, 61 (82%) completed the study', 'participants with severe to very severe COPD', 'participants with severe and very severe COPD during a long term follow-up of one year as compared to usual care']","['Pedometer-Based Physical Activity Coaching', 'physical activity programs', 'physical activity counselling and pedometer-based feedback', 'control group receiving usual care or an intervention group receiving motivational support, an activity diary with an individual step count goal (ie, an increase of ≥15% from baseline) and a pedometer in addition to usual care']","['step count', 'daily step count after one year']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",74.0,0.13788,"Linear regression modelling, adjusted for baseline step count, showed no significant difference in change in step count after 12 months between the groups (Β = 547.33, 95% CI = -243.55/1338.20).
","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Kohlbrenner', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Noriane A', 'Initials': 'NA', 'LastName': 'Sievi', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Senn', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Clarenbach', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S279293']
1761,33192116,Minithoracoscope versus Conventional Medical Thoracoscope in Patients with Exudative Pleural Effusion.,"Background


Thoracoscopy allows visualization of the pleural cavity including diaphragm, visceral pleura, and lungs. It provides the physician with information about the disease extent and it has the ability to get a biopsy from these lesions to differentiate between tumors and fibrotic reactions. This study aims to compare minithoracoscopy and medical thoracoscope in patients with exudative pleural effusion as regards the diagnostic yield, safety, complications, and duration of hospital stay.
Patients and methods


Sixty patients were diagnosed with exudative pleural effusion and were randomly divided into 2 equal groups: Group (1): included 30 patients who underwent minithoracoscopy and Group (2): included the remaining 30 cases who underwent the standard thoracoscope.
Results


Pathological examination of the sample revealed that biopsy size was 2.02 and 1.25 in group 1 and group 2 was respectively with highly statistically significant between both groups ( P  < .001). Group 1 revealed TB, malignant, chronic nonspecific pleurisy, Staph aureus, Klebsiella, and Pseudomonas in 30% (9), 30% (9), 33.3% (10), 69% (9), 15% (2), and 15% (2) of cases respectively. While group 2 reveled TB, malignancy, chronic nonspecific pleurisy, Staph aureus, Klebsiella, Pseudomonas, and other causes in 40% (12), 23.3% (7), 23.3% (7), 67% (8), 8% (1), 8% (1), and 16% (2) respectively with no statistically significant differences between both groups ( P  > .05).
Conclusion


Minithoracoscopy is well tolerated by patients as minimal pain and early hospital discharge could be achieved by that approach.",2020,"Conclusion


Minithoracoscopy is well tolerated by patients as minimal pain and early hospital discharge could be achieved by that approach.","['30 patients who underwent minithoracoscopy and Group (2): included the remaining 30 cases who underwent the standard thoracoscope', 'patients with exudative pleural effusion', 'Patients with Exudative Pleural Effusion', 'Patients and methods\n\n\nSixty patients were diagnosed with exudative pleural effusion']","['minithoracoscopy and medical thoracoscope', 'Minithoracoscope versus Conventional Medical Thoracoscope']","['reveled TB, malignancy, chronic nonspecific pleurisy, Staph aureus, Klebsiella, Pseudomonas', 'TB, malignant, chronic nonspecific pleurisy, Staph aureus, Klebsiella, and Pseudomonas', 'biopsy size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0183932', 'cui_str': 'Thoracoscope'}, {'cui': 'C0264551', 'cui_str': 'Pleurisy with effusion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0183932', 'cui_str': 'Thoracoscope'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032231', 'cui_str': 'Pleurisy'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",60.0,0.0343894,"Conclusion


Minithoracoscopy is well tolerated by patients as minimal pain and early hospital discharge could be achieved by that approach.","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Okasha Hamoda', 'Affiliation': 'Chest Medicine Department, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Sayed Ahmed Mohamed', 'Initials': 'SAM', 'LastName': 'Abdel Hafez', 'Affiliation': 'Chest Medicine Department, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Abouelkhier Abdalla', 'Affiliation': 'Chest Medicine Department, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abd Alhady Mohamed', 'Initials': 'AAM', 'LastName': 'Shebl', 'Affiliation': 'Pathology Department, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elnahas', 'Affiliation': 'Clinical Pathology Department, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Nasef Abd-Elsalam', 'Initials': 'NA', 'LastName': 'Rezk', 'Affiliation': 'Chest Medicine Department, Mansoura University, Mansoura, Egypt.'}]","Clinical medicine insights. Circulatory, respiratory and pulmonary medicine",['10.1177/1179548420966243']
1762,33192170,Online cognitive behavioral group therapy (iCBT-I) for insomnia for school children and their parents: Adaptation of an established treatment (KiSS training).,"Background


Due to the SARS-CoV‑2 crisis, online adaptation of sleep trainings is necessary. As sleep disturbances in school children are common, prevention of chronification is essential. The aim of this study was to adapt an established age-oriented cognitive behavioral therapy for insomnia (CBT-I) group training for 5-10-year-old children with insomnia and their parents to an online version (group iCBT-I).
Methods


The adaptation procedure and structure of the iCBT‑I are described. To assess acceptance the Online Sleep Treatment Acceptance questionnaire (OSTA) and the Online Sleep Treatment Feedback questionnaire (OSTF) were implemented. In addition, trainers filled in the Adherence and Feasibility Questionnaire for Online Sleep Treatment (AFOST). Sleep problems were assessed using a structured interview for sleep disorders in children and clinical interview, and the Children's Sleep Habit Questionnaire (CSHQ-DE). Emotional problems were evaluated with the Child Behavior Checklist (CBCL 4-18).
Results


This pilot study included 12 parents and 6 children fulfilling insomnia criteria prior to online training. The adapted online version consisted of three parental sessions, whereas child-oriented sessions were transferred into videoclips. The new group iCBT‑I was well accepted by parents. Parents scored the online version as helpful and time saving based on the OSTA and trainers estimated the adapted version to be feasible and effective. According to AFOST, adherence was given. After training, 67% of children showed reduced sleep problems according to parental rating.
Conclusion


Parental acceptance of a group iCBT‑I for school children and their parents was very good and parents scored the videos for their children as very helpful. Trainers declared the adapted version to be feasible. A further study with a larger sample is necessary.",2020,"Conclusion


Parental acceptance of a group iCBT‑I for school children and their parents was very good and parents scored the videos for their children as very helpful.","['5-10-year-old children with insomnia and their parents to an online version (group iCBT-I', '12\xa0parents and 6\xa0children fulfilling insomnia criteria prior to online training', 'school children', 'school children and their parents']","['cognitive behavioral therapy for insomnia (CBT-I) group training', 'Online cognitive behavioral group\xa0therapy (iCBT-I']","['Emotional problems', 'acceptance the Online Sleep Treatment Acceptance questionnaire (OSTA) and the Online Sleep Treatment Feedback questionnaire (OSTF', 'Sleep problems', 'Child Behavior Checklist', 'reduced sleep problems', ""Children's Sleep Habit Questionnaire (CSHQ-DE""]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2133558', 'cui_str': 'Sleep Habits'}]",,0.0172256,"Conclusion


Parental acceptance of a group iCBT‑I for school children and their parents was very good and parents scored the videos for their children as very helpful.","[{'ForeName': 'Angelika A', 'Initials': 'AA', 'LastName': 'Schlarb', 'Affiliation': 'Department of Psychology and Sports Science, Bielefeld University, Universitätsstraße\xa025, 33615 Bielefeld, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Schulte', 'Affiliation': 'HaKiJu Hochschulambulanz für Kinder und Jugendliche und ihre Familien, Bielefeld University, Morgenbreede\xa012, 33615 Bielefeld, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Selbmann', 'Affiliation': 'HaKiJu Hochschulambulanz für Kinder und Jugendliche und ihre Familien, Bielefeld University, Morgenbreede\xa012, 33615 Bielefeld, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Och', 'Affiliation': 'HaKiJu Hochschulambulanz für Kinder und Jugendliche und ihre Familien, Bielefeld University, Morgenbreede\xa012, 33615 Bielefeld, Germany.'}]",Somnologie : Schlafforschung und Schlafmedizin = Somnology : sleep research and sleep medicine,['10.1007/s11818-020-00280-7']
1763,33192186,Influences of Dual-Task Training on Walking and Cognitive Performance of People With Relapsing Remitting Multiple Sclerosis: Randomized Controlled Trial.,"Objective


We sought to investigate whether there is any additional effect of coupled cognitive and physical rehabilitation compared to exercise training alone on walking and cognitive performance in individuals with relapsing remitting multiple sclerosis (RRMS).
Methods


A randomized controlled trial was conducted from March to November 2015 with 30 individuals with RRMS (aged 20 to 50 years; 21 women, 9 men), who underwent detailed medical and neurologic examination. They were randomly allocated using sealed envelopes to either the study group, who received physical and cognitive rehabilitation (dual-task training), or the control group, who received physical rehabilitation alone. Participants (in both groups) were assessed twice (8 weeks apart), before and after rehabilitation. Assessment tools were the Mini-Mental State Examination (MMSE), the Expanded Disability Status Scale (EDSS), neuropsychological evaluation (using RehaCom), and walking tests.
Results


After training, the control group significantly improved regarding MMSE, attention/concentration test, and 10-meter walking test, whereas the scores of the study group significantly improved in all studied parameters (Expanded Disability Status Scale, MMSE, logical reasoning, and attention/concentration and walking tests). The differential (delta) scores from before to after rehabilitation were significantly higher in the study group for logical reasoning, attention/concentration, and 2-minute walking distance scores.
Conclusions


Coupled physical and cognitive (dual-task) training showed concurrent improvement in cognitive and walking abilities in individuals with RRMS which exceeded that achieved by physical training alone.",2020,"The differential (delta) scores from before to after rehabilitation were significantly higher in the study group for logical reasoning, attention/concentration, and 2-minute walking distance scores.
","['March to November 2015 with 30 individuals with RRMS (aged 20 to 50 years; 21 women, 9 men), who underwent detailed medical and neurologic examination', 'individuals with RRMS', 'People With Relapsing Remitting Multiple Sclerosis', 'individuals with relapsing remitting multiple sclerosis (RRMS']","['physical and cognitive rehabilitation (dual-task training), or the control group, who received physical rehabilitation alone', 'Dual-Task Training', 'coupled cognitive and physical rehabilitation', 'exercise training alone']","['differential (delta) scores', 'cognitive and walking abilities', 'regarding MMSE, attention/concentration test, and 10-meter walking test', 'Mini-Mental State Examination (MMSE), the Expanded Disability Status Scale (EDSS), neuropsychological evaluation (using RehaCom), and walking tests', 'studied parameters (Expanded Disability Status Scale, MMSE, logical reasoning, and attention/concentration and walking tests', 'logical reasoning, attention/concentration, and 2-minute walking distance scores', 'walking and cognitive performance', 'Walking and Cognitive Performance']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0257199,"The differential (delta) scores from before to after rehabilitation were significantly higher in the study group for logical reasoning, attention/concentration, and 2-minute walking distance scores.
","[{'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Elwishy', 'Affiliation': 'Department of Neuromuscular Disorders and Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Asmaa M', 'Initials': 'AM', 'LastName': 'Ebraheim', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amal S', 'Initials': 'AS', 'LastName': 'Ashour', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abeer A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Neuromuscular Disorders and Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abd El Hamied E El', 'Initials': 'AEHEE', 'LastName': 'Sherbini', 'Affiliation': 'National Institute of Longevity Elderly Sciences, Department of Occupational Therapy, Beni Suef University, Beni Suef, Egypt.'}]",Journal of chiropractic medicine,['10.1016/j.jcm.2019.08.002']
1764,33192380,The Effects of Anodal Transcranial Direct Current Stimulation on Sleep Time and Efficiency.,"A single session of anodal transcranial direct current stimulation (tDCS) has been shown to increase arousal in healthy participants for up to 24 h post-stimulation. However, little is known about the effects of tDCS on subsequent sleep in this population. Based on previous clinical studies, we hypothesized that anodal stimulation to the left dorsolateral prefrontal cortex (lDLPFC) would produce higher arousal with decreased sleep time and stimulation to the primary motor cortex (M1) would have the converse effect. Thirty-six active duty military were randomized into one of three groups ( n  = 12/group); active anodal tDCS over the lDLPFC, active anodal tDCS over left M1, or sham tDCS. Participants answered questionnaires 3 times a day and wore a wrist activity monitor (WAM) to measure sleep time and efficiency for 3 weeks. On weeks 2 and 3 (order counterbalance), participants received stimulation at 1800 h before 26 h of sustained wakefulness testing (sleep deprived) and at 1800 h without sleep deprivation (non-sleep deprived). There were no significant effects for the non-sleep deprived portion of testing. For the sleep deprived portion of testing, there were main effects of group and night on sleep time. The DLPFC group slept less than the other groups on the second and third night following stimulation. There is no negative effect on mood or sleep quality from a single dose of tDCS when participants have normal sleep patterns (i.e., non-sleep deprived portion of testing). The results suggest that stimulation may result in faster recovery from fatigue caused by acute periods of sleep deprivation, as their recovery sleep periods were less.",2020,"There is no negative effect on mood or sleep quality from a single dose of tDCS when participants have normal sleep patterns (i.e., non-sleep deprived portion of testing).","['Thirty-six active duty military', 'healthy participants for up to 24 h post-stimulation']","['active anodal tDCS over the lDLPFC, active anodal tDCS over left M1, or sham tDCS', 'stimulation at 1800 h before 26 h of sustained wakefulness testing (sleep deprived) and at 1800 h without sleep deprivation', 'Anodal Transcranial Direct Current Stimulation', 'anodal transcranial direct current stimulation (tDCS', 'tDCS']","['mood or sleep quality', 'sleep time', 'wrist activity monitor (WAM) to measure sleep time and efficiency', 'Sleep Time and Efficiency']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0192661,"There is no negative effect on mood or sleep quality from a single dose of tDCS when participants have normal sleep patterns (i.e., non-sleep deprived portion of testing).","[{'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'McIntire', 'Affiliation': 'Infoscitex, Inc., Wright-Patterson Air Force Base, Dayton, OH, United States.'}, {'ForeName': 'R Andy', 'Initials': 'RA', 'LastName': 'McKinley', 'Affiliation': 'Air Force Research Laboratory/Applied Neuroscience Branch, Wright-Patterson Air Force Base, Dayton, OH, United States.'}, {'ForeName': 'Chuck', 'Initials': 'C', 'LastName': 'Goodyear', 'Affiliation': 'Infoscitex, Inc., Wright-Patterson Air Force Base, Dayton, OH, United States.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'McIntire', 'Affiliation': 'Air Force Research Laboratory/Security and Intelligence Branch, Wright-Patterson Air Force Base, Dayton, OH, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00357']
1765,33192404,Competition Enhances the Effectiveness and Motivation of Attention Rehabilitation After Stroke. A Randomized Controlled Trial.,"Attention deficits are among the most common cognitive impairments observed after experiencing stroke. However, a very limited number of studies have investigated the effectiveness of interventions that specifically focus on the rehabilitation of attention deficits among subjects with impaired attention. Although several interventions have included the use of computerized programs to provide dynamic stimuli, real-time performance feedback, and motivating tasks, existing studies have not exploited the potential benefits of multi-user interactions. Group-based and competitive interventions have been reported to be more enjoyable and motivating, depending on individual traits, and may potentially be more demanding, which may increase their effectiveness. This study investigated the effectiveness and motivating abilities of an intervention specifically designed to address attention deficits. This intervention combined paper-and-pencil tasks and interactive, computerized, multi-touch exercises, which were administered, either non-competitively or competitively, to a group of 43 individuals with chronic stroke. The mediating effects of competitiveness were evaluated for both intervention effectiveness and motivation. Participants were randomly sorted into two groups and underwent 20 one-hour group-based sessions, during which they either worked individually or competed with peers, according to their group allocation. Participants were assessed before and after the intervention, using the Conners' Continuous Performance Test, the d2 Test of Attention, the Color Trail Test, the Digit Span Test, and the Spatial Span Test. The competitiveness and subjective experiences of the participants after the intervention were investigated with the Revised Competitiveness Index and the Intrinsic Motivation Inventory, respectively. The results showed that participants who competed demonstrated significantly greater improvements in all cognitive abilities, except for divided attention, and reported greater enjoyment than their non-competitive peers. Both groups reported comparable levels of perceived competence, pressure, and usefulness. Interestingly, the competitiveness of the participants did not alter either the effectiveness or the subjective experience of the intervention. These findings suggest that competition might enhance the effectiveness and enjoyment of rehabilitation interventions designed to address attention deficits in individuals post-stroke, regardless of their level of competitiveness and without having a negative effect on their perceived pressure and competence.",2020,"The competitiveness and subjective experiences of the participants after the intervention were investigated with the Revised Competitiveness Index and the Intrinsic Motivation Inventory, respectively.","['subjects with impaired attention', '43 individuals with chronic stroke']",[],"['levels of perceived competence, pressure, and usefulness', 'cognitive abilities']","[{'cui': 'C0238707', 'cui_str': 'Impairment of attention'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",43.0,0.0359905,"The competitiveness and subjective experiences of the participants after the intervention were investigated with the Revised Competitiveness Index and the Intrinsic Motivation Inventory, respectively.","[{'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Navarro', 'Affiliation': 'NEURORHB, Servicio de Neurorrehabilitación de Hospitales Vithas, Fundación Vithas, València, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Llorens', 'Affiliation': 'NEURORHB, Servicio de Neurorrehabilitación de Hospitales Vithas, Fundación Vithas, València, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Borrego', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de Investigación e Innovación en Bioingeniería, Universitat Politècnica de València, València, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Alcañiz', 'Affiliation': 'Neurorehabilitation and Brain Research Group, Instituto de Investigación e Innovación en Bioingeniería, Universitat Politècnica de València, València, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Noé', 'Affiliation': 'NEURORHB, Servicio de Neurorrehabilitación de Hospitales Vithas, Fundación Vithas, València, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Ferri', 'Affiliation': 'NEURORHB, Servicio de Neurorrehabilitación de Hospitales Vithas, Fundación Vithas, València, Spain.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.575403']
1766,33192406,Inter- and Intra-individual Variability in Brain Oscillations During Sports Motor Imagery.,"The aim of this work was to re-evaluate electrophysiological data from a previous study on motor imagery (MI) with a special focus on observed inter- and intra-individual differences. More concretely, we investigated event-related desynchronization/synchronization patterns during sports MI (playing tennis) compared with simple MI (squeezing a ball) and discovered high variability across participants. Thirty healthy volunteers were divided in two groups; the experimental group (EG) performed a physical exercise between two imagery sessions, and the control group (CG) watched a landscape movie without physical activity. We computed inter-individual differences by assessing the dissimilarities among subjects for each group, condition, time period, and frequency band. In the alpha band, we observe some clustering in the ranking of the subjects, therefore showing smaller distances than others. Moreover, in our statistical evaluation, we observed a consistency in ranking across time periods both for the EG and for the CG. For the latter, we also observed similar rankings across conditions. On the contrary, in the beta band, the ranking of the subjects was more similar for the EG across conditions and time periods than for the subjects of the CG. With this study, we would like to draw attention to variability measures instead of primarily focusing on the identification of common patterns across participants, which often do not reflect the whole neurophysiological reality.",2020,"On the contrary, in the beta band, the ranking of the subjects was more similar for the EG across conditions and time periods than for the subjects of the CG.",['Thirty healthy volunteers'],"['physical exercise between two imagery sessions, and the control group (CG) watched a landscape movie without physical activity']",['Inter- and Intra-individual Variability in Brain Oscillations'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0681495', 'cui_str': 'Movies'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",30.0,0.0136059,"On the contrary, in the beta band, the ranking of the subjects was more similar for the EG across conditions and time periods than for the subjects of the CG.","[{'ForeName': 'Selina C', 'Initials': 'SC', 'LastName': 'Wriessnegger', 'Affiliation': 'Institute of Neural Engineering, Graz University of Technology, Graz, Austria.'}, {'ForeName': 'Gernot R', 'Initials': 'GR', 'LastName': 'Müller-Putz', 'Affiliation': 'Institute of Neural Engineering, Graz University of Technology, Graz, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Brunner', 'Affiliation': 'Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Andreea I', 'Initials': 'AI', 'LastName': 'Sburlea', 'Affiliation': 'Institute of Neural Engineering, Graz University of Technology, Graz, Austria.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.576241']
1767,33192415,Effects of Different Stimulation Conditions on the Stimulation Effect of Noisy Galvanic Vestibular Stimulation.,"Balance disorders are a risk factor for falls in the elderly population. Balance control involving the complex interaction among nervous, muscular, and sensory systems should be maintained to keep an upright posture and prevent falls. Vestibular sensation is one of the main senses essential for postural control. Noisy galvanic vestibular stimulation (nGVS) is a noninvasive stimulation method for vestibular organs. Recently, it has received increasing attention for the treatment of balance disorders. However, the effect of balance disorders on stimulus effect during the implementation of nGVS remains unknown. Therefore, this study aimed to determine the effects of different floor surface and visual conditions on the stimulus effects of the nGVS intervention. In this study, two experiments were conducted with 24 participants (12 each for Experiments 1 and 2). In Experiment 1, nGVS (0.4 mA; 0.1-640 Hz) was performed in the open-eyes standing position on a solid surface (nGVS condition) and in the closed-eye standing position on a foam rubber (nGVS + foam rubber condition). In Experiment 2, sham stimulation was performed under the same conditions as in Experiment 1, except for nGVS. Center of pressure (COP) sway was measured in all participants with them standing with open eyes at Pre and Post-1 (immediately after the intervention) and Post-2 (10 min after the measurement of post-1). In Experiment 1, under the nGVS condition, COP sway was significantly reduced in Post-1 and Post-2 compared with Pre. However, no significant difference was observed among Pre, Post-1, and Post-2 under the nGVS + foam rubber condition. Furthermore, the intervention effect was significantly greater in the nGVS condition than in the nGVS + foam rubber condition. In contrast, in Experiment 2, the COP sway did not significantly differ among Pre, Post-1, and Post-2 under either condition. Based on the results of this study, nGVS was found to be effective with open-eyes standing on a solid surface.",2020,"Furthermore, the intervention effect was significantly greater in the nGVS condition than in the nGVS + foam rubber condition.",['24 participants (12 each for Experiments 1 and 2'],"['Noisy galvanic vestibular stimulation (nGVS', 'nGVS intervention']","['COP sway', 'Center of pressure (COP) sway']",[],"[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",2.0,0.0201869,"Furthermore, the intervention effect was significantly greater in the nGVS condition than in the nGVS + foam rubber condition.","[{'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Miyaguchi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Department of Rehabilitation, Kaetsu Hospital, Niigata, Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Otsuru', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.581405']
1768,33192438,Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation.,"Stroke is the leading cause of severe disability in adults resulting in mobility, balance, and coordination deficits. Robotic exoskeletons (REs) for stroke rehabilitation can provide the user with consistent, high dose repetition of movement, as well as balance and stability. The goal of this intervention study is to evaluate the ability of a RE to provide high dose gait therapy and the resulting effect on functional recovery for individuals with acute stroke. The investigation included a total of 44 participants. Twenty-two participants received RE gait training during inpatient rehabilitation (RE+SOC Group), and a matched sample of 22 individuals admitted to the same inpatient rehabilitation facility-receiving conventional standard of care treatment (SOC group). The effect of RE training was quantified using total distance walked during inpatient rehabilitation and functional independence measure (FIM). The total distance walked during inpatient rehabilitation showed a significant difference between the SOC and RE+SOC groups. RE+SOC walked twice the distance as SOC during the same duration (time spent in inpatient rehabilitation) of training. In addition, the average change in motor FIM showed a significant difference between the SOC and RE+SOC groups, where the average difference in motor FIM was higher in RE+SOC compared to the SOC group. The results suggest that RE provided increased dosing of gait training without increasing the duration of training during acute stroke rehabilitation. The RE+SOC group increased their motor FIM score (change from admission to discharge) compared to SOC group, both groups were matched for admission motor FIM scores suggesting that increased dosing may have improved motor function.",2020,"The RE+SOC group increased their motor FIM score (change from admission to discharge) compared to SOC group, both groups were matched for admission motor FIM scores suggesting that increased dosing may have improved motor function.","['44 participants', 'individuals with acute stroke', '22 individuals admitted to the same inpatient rehabilitation facility-receiving conventional standard of care treatment (SOC group']","['RE gait training', 'Robotic Exoskeleton Gait Training', 'Robotic exoskeletons (REs', 'RE', 'gait training', 'RE training']","['total distance walked', 'average change in motor FIM', 'motor function', 'motor FIM', 'motor FIM score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C4046099', 'cui_str': 'Robotic Exoskeleton'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C4274266', 'cui_str': 'Functional Independence Measure score'}]",44.0,0.0247201,"The RE+SOC group increased their motor FIM score (change from admission to discharge) compared to SOC group, both groups were matched for admission motor FIM scores suggesting that increased dosing may have improved motor function.","[{'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Nolan', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, United States.'}, {'ForeName': 'Kiran K', 'Initials': 'KK', 'LastName': 'Karunakaran', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Chervin', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Monfett', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers - New Jersey Medical School (NJMS), Newark, NJ, United States.'}, {'ForeName': 'Radhika K', 'Initials': 'RK', 'LastName': 'Bapineedu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers - New Jersey Medical School (NJMS), Newark, NJ, United States.'}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Jasey', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rutgers - New Jersey Medical School (NJMS), Newark, NJ, United States.'}, {'ForeName': 'Mooyeon', 'Initials': 'M', 'LastName': 'Oh-Park', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, United States.'}]",Frontiers in neurorobotics,['10.3389/fnbot.2020.581815']
1769,33192485,"Effects of Aerobic Exercise, Cognitive and Combined Training on Cognition in Physically Inactive Healthy Late-Middle-Aged Adults: The Projecte Moviment Randomized Controlled Trial.","Background


Lifestyle interventions are promising strategies to promote cognitive health in aging. Projecte Moviment examines if aerobic exercise (AE), computerized cognitive training (CCT), and their combination (COMB) improves cognition, psychological health, and physical status compared to a control group. We assessed the moderating role of age and sex and the mediating effects of cardiorespiratory fitness (CRF), physical activity (PA), and psychological health on intervention-related cognitive benefits.
Methods


This was a 12-week multi-domain, single-blind, proof-of-concept randomized controlled trial (RCT). 96 healthy adults aged 50-70 years were assigned to AE, CCT, COMB, and a wait-list control group. The per protocol sample, which completed the intervention with a level of adherence > 80%, consisted of 82 participants (62% female; age = 58.38 ± 5.47). We assessed cognition, psychological health, CRF, and energy expenditure in PA at baseline and after the intervention. We regressed change in each outcome on the treatment variables, baseline score, sex, age, and education. We used PROCESS Macro to perform the mediation and moderation analyses.
Results


AE benefited Working Memory (SMD = 0.29,  p  = 0.037) and Attention (SMD = 0.33,  p  = 0.028) including the Attention-Speed (SMD = 0.31,  p  = 0.042) domain, compared to Control. COMB improved Attention (SMD = 0.30,  p  = 0.043), Speed (SMD = 0.30,  p  = 0.044), and the Attention-Speed (SMD = 0.30,  p  = 0.041) domain. CTT group did not show any cognitive change compared to Control. Sportive PA (S-PA) and CRF increased in AE and COMB. Age and sex did not moderate intervention-related cognitive benefits. Change in S-PA, but not in CRF, significantly mediated improvements on Attention-Speed in AE.
Conclusion


A 12-week AE program improved Executive Function and Attention-Speed in healthy late-middle-aged adults. Combining it with CCT did not provide further benefits. Our results add support to the clinical relevance of even short-term AE as an intervention to enhance cognition and highlight the mediating role of change in S-PA in these benefits.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier NCT03123900.",2020,"COMB improved Attention (SMD = 0.30,  p  = 0.043), Speed (SMD = 0.30,  p  = 0.044), and the Attention-Speed (SMD = 0.30,  p  = 0.041) domain.","['Physically Inactive Healthy Late-Middle-Aged Adults', 'healthy late-middle-aged adults', '96 healthy adults aged 50-70 years']","['CCT', 'CTT', 'aerobic exercise (AE), computerized cognitive training (CCT), and their combination (COMB', 'Aerobic Exercise, Cognitive and Combined Training']","['Sportive PA (S-PA) and CRF', 'COMB improved Attention', 'cardiorespiratory fitness (CRF), physical activity (PA), and psychological health', 'Executive Function and Attention-Speed', 'Attention-Speed in AE', 'Attention-Speed', 'cognition, psychological health, CRF, and energy expenditure in PA', 'cognition, psychological health, and physical status']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",96.0,0.101095,"COMB improved Attention (SMD = 0.30,  p  = 0.043), Speed (SMD = 0.30,  p  = 0.044), and the Attention-Speed (SMD = 0.30,  p  = 0.041) domain.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Roig-Coll', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Castells-Sánchez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Lamonja-Vicente', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Torán-Monserrat', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Mataró, Spain.""}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Pera', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Mataró, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'García-Molina', 'Affiliation': 'Institut Guttmann, Institut Universitari de Neurorehabilitació, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Maria', 'Initials': 'JM', 'LastName': 'Tormos', 'Affiliation': 'Institut Guttmann, Institut Universitari de Neurorehabilitació, Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Montero-Alía', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Mataró, Spain.""}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Alzamora', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Mataró, Spain.""}, {'ForeName': 'Rosalía', 'Initials': 'R', 'LastName': 'Dacosta-Aguayo', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Soriano-Raya', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Cáceres', 'Affiliation': 'Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'Kirk I', 'Initials': 'KI', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mataró', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Barcelona, Barcelona, Spain.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.590168']
1770,33192494,Corrigendum: A Multi-Ingredient Nutritional Supplement in Combination With Resistance Exercise and High-Intensity Interval Training Improves Cognitive Function and Increases  N -3 Index in Healthy Older Men: A Randomized Controlled Trial.,[This corrects the article DOI: 10.3389/fnagi.2019.00107.].,2020,[This corrects the article DOI: 10.3389/fnagi.2019.00107.].,['Healthy Older Men'],['High-Intensity Interval Training'],['Cognitive Function and Increases  N -3 Index'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0656437,[This corrects the article DOI: 10.3389/fnagi.2019.00107.].,"[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Bell', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Snijders', 'Affiliation': 'NUTRIM, Department of Human Biology, Maastricht University Medical Centre, Maastricht, Netherlands.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Allison', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Zulyniak', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chabowski', 'Affiliation': 'Department of Physiology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Parise', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Heisz', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.611387']
1771,33192496,"Expression of Concern: Effect of Probiotic Supplementation on Cognitive Function and Metabolic Status in Alzheimer's Disease: A Randomized, Double-Blind and Controlled Trial.",,2020,,"[""Alzheimer's Disease""]",['Probiotic Supplementation'],['Cognitive Function and Metabolic Status'],"[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.628631,,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.602204']
1772,33176394,Multicentre randomised controlled trial about the effect of individual reminiscence therapy in older adults with neurocognitive disorders.,"OBJECTIVES


To evaluate the effectiveness of a 13-week individual reminiscence therapy (RT) intervention to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorders.
METHODS


A single-blind, multicentre, randomised parallel two-arm controlled trial recruited 251 people with neurocognitive disorders attending 24 institutions providing care and support services for older adults in Portugal. The primary outcome measure was cognitive function (Mini-Mental State Examination [MMSE]). Secondary outcomes were memory (Memory Alteration Test [MAT]), executive function (Frontal Assessment Battery [FAB]), mood (Geriatric Depression Scale-15 [GDS-15]) and self-reported QoL-Alzheimer's disease AD). Participants in the intervention group (n = 131) received 26 individual RT sessions, twice a week, over the course of 13 weeks. Participants in the control group (n = 120) maintained their treatment as usual.
RESULTS


Intention-to-treat analysis showed that, at endpoint assessment, the intervention group had significantly improved in relation to the control group in MMSE (mean difference 1.84, 95% CI [0.80, 2.89], p = .001, d = .44), MAT (mean difference 2.82, 95% CI [0.72, 4.91], p = .009, d = .34) and QoL-AD (mean difference 1.78, 95% CI [0.17, 3.39], p = .031, d = .28). Non-significant improvements were found on FAB (mean difference 0.74, 95% CI [-0.04, 1.52], p = .062, d = .24) and GDS-15 (mean difference -0.63, 95% CI [-1.45, 0.19], p = .130, d = .19).
CONCLUSIONS


For people with neurocognitive disorders attending social care and support services, the individual RT designed for this trial should be considered an intervention with the potential to improve cognition, memory and QoL.",2020,"Non-significant improvements were found on FAB (mean difference 0.74, 95% CI [-0.04, 1.52], p = .062, d = .24) and GDS-15 (mean difference -0.63, 95% CI [-1.45, 0.19], p =.130, d = .19).
","['251 people with neurocognitive disorders attending 24 institutions providing care and support services for older adults in Portugal', 'people with neurocognitive disorders attending social care and support services', 'people with neurocognitive disorders', 'Older Adults with Neurocognitive Disorders']","['Individual Reminiscence Therapy', 'individual Reminiscence Therapy intervention', '26 individual Reminiscence therapy sessions']","['cognition, memory, and quality of life', 'memory (MAT), executive function (FAB), mood (GDS-15), and self-reported quality of life (QoL-AD', 'QoL-AD', 'FAB', 'GDS-15', 'overall cognitive function, memory, executive function, mood, and quality of life', 'cognitive function (MMSE']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0419189', 'cui_str': 'Social care'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021031', 'cui_str': 'Immunoglobulin, F(ab) fragment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]",251.0,0.164452,"Non-significant improvements were found on FAB (mean difference 0.74, 95% CI [-0.04, 1.52], p = .062, d = .24) and GDS-15 (mean difference -0.63, 95% CI [-1.45, 0.19], p =.130, d = .19).
","[{'ForeName': 'Susana I', 'Initials': 'SI', 'LastName': 'Justo-Henriques', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Pérez-Sáez', 'Affiliation': ""National Reference Centre for Alzheimer's and Dementia Care, Imserso, Salamanca, Spain.""}, {'ForeName': 'João L', 'Initials': 'JL', 'LastName': 'Alves Apóstolo', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA:E), Nursing School of Coimbra, Coimbra, Portugal.'}]",International journal of geriatric psychiatry,['10.1002/gps.5469']
1773,33176700,Comparison of practicability and effectiveness between unassisted HIV self-testing and directly assisted HIV self-testing in the Democratic Republic of the Congo: a randomized feasibility trial.,"BACKGROUND


HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability and effectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC).
METHODS


A randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression.
RESULTS


The rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of - 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P < 0.001).
CONCLUSION


The results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach.
TRIAL REGISTRATION


PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032.",2020,"After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019).","['Registered 03 April 2019 ', 'individuals at high risk for HIV infection in Kisangani, the DRC']","['unassisted HIV self-testing and directly assisted HIV self-testing', 'UH', 'HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH', 'blood-based and facility-based HIVST method']","['practicability and effectiveness', 'positivity rate, requests for assistance, and linkage to care', 'Practicability', 'adjusted risk ratios (aRRs', 'Willingness to buy an HIV self-test', 'positivity rate', 'practicability of the HIV self-test']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0043444', 'cui_str': 'Zaire'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0772476,"After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019).","[{'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Tonen-Wolyec', 'Affiliation': ""Ecole Doctorale Régionale D'Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon. wolyec@gmail.com.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kayembe Tshilumba', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Batina-Agasa', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': ""Marini Djang'eing'a"", 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Hayette', 'Affiliation': 'Department of Clinical Microbiology, University Hospital of Liège, Liege, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Belec', 'Affiliation': 'Laboratory of virology, Hôpital Européen Georges Pompidou, and University of Paris Descartes, Paris Sorbonne Cité, Paris, France.'}]",BMC infectious diseases,['10.1186/s12879-020-05554-x']
1774,33176727,Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence.,"BACKGROUND


Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care.
METHODS


StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4-10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4-10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks.
DISCUSSION


Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence.
TRIAL REGISTRATION


The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111-1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true ).",2020,"Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID).","['Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS)\u2009=\u20094-10) and with a regular male partner', 'women diagnosed with BV and their male partner', 'Treating male partners of women with bacterial vaginosis (StepUp', '12 February 2019 on the Australian and New Zealand Clinical Trial Registry']","['topical vaginal 2% clindamycin', 'current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7\u2009days of combined antibiotics - oral metronidazole tablets 400\u2009mg BID and 2% clindamycin cream', 'metronidazole']","['risk of BV recurrence', 'BV recurrence', 'adherence, tolerability and acceptability of male partner treatment', 'BV recurrence rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0326863', 'cui_str': 'Blackbird'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0360345', 'cui_str': 'Metronidazole-containing product in oral dose form'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.390261,"Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID).","[{'ForeName': 'Lenka A', 'Initials': 'LA', 'LastName': 'Vodstrcil', 'Affiliation': 'Central Clinical School, Monash University, Carlton, VIC, 3053, Australia. lenka.vodstrcil@monash.edu.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Plummer', 'Affiliation': 'Central Clinical School, Monash University, Carlton, VIC, 3053, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Doyle', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC, 3053, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Central Clinical School, Monash University, Carlton, VIC, 3053, Australia.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'McGuiness', 'Affiliation': 'Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC, 3053, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bateson', 'Affiliation': 'Family Planning New South Wales, Ashfield, 2131, Australia.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Hocking', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population & Global Health, University of Melbourne, Parkville, 3010, Australia.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Law', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, 2052, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Petoumenos', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, 2052, Australia.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Donovan', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, 2052, Australia.'}, {'ForeName': 'Eric P F', 'Initials': 'EPF', 'LastName': 'Chow', 'Affiliation': 'Central Clinical School, Monash University, Carlton, VIC, 3053, Australia.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Bradshaw', 'Affiliation': 'Central Clinical School, Monash University, Carlton, VIC, 3053, Australia. catriona.bradshaw@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC infectious diseases,['10.1186/s12879-020-05563-w']
1775,33177145,Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial.,"INTRODUCTION


Prone positioning (PP) is an effective first-line intervention to treat patients with moderate to severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation, as it improves gas exchanges and reduces mortality. The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size. High-level evidence of awake PP for hypoxaemic patients with COVID-19 patients is still lacking.
METHODS AND ANALYSIS


The protocol of this meta-trial is a prospective collaborative individual participant data meta-analysis of randomised controlled open label superiority trials. This design is particularly adapted to a rapid scientific response in the pandemic setting. It will take place in multiple sites, among others in USA, Canada, Ireland, France and Spain. Patients will be followed up for 28 days. Patients will be randomised to receive whether awake PP and nasal high flow therapy or standard medical treatment and nasal high flow therapy. Primary outcome is defined as the occurrence rate of tracheal intubation or death up to day 28. An interim analysis plan has been set up on aggregated data from the participating research groups.
ETHICS AND DISSEMINATION


Ethics approvals were obtained in all participating countries. Results of the meta-trial will be submitted for publication in a peer-reviewed journal. Each randomised controlled trial was registered individually, as follows: NCT04325906, NCT04347941, NCT04358939, NCT04395144 and NCT04391140.",2020,The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size.,"['patients with moderate to severe acute respiratory distress syndrome (ARDS) receiving', 'awake spontaneous breathing patients with ARDS secondary to COVID-19', 'hypoxaemic patients with COVID-19', 'hypoxaemic patients with COVID-19 patients']","['invasive mechanical ventilation', 'Prone positioning (PP', 'awake PP and nasal high flow therapy or standard medical treatment and nasal high flow therapy']",['occurrence rate of tracheal intubation or death up to day 28'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.248505,The use of PP in awake spontaneous breathing patients with ARDS secondary to COVID-19 was reported to improve oxygenation in few retrospective trials with small sample size.,"[{'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Tavernier', 'Affiliation': 'Clinical Investigation Center, INSERM 1415, CHRU Tours, Tours, Centre, France elsa.tavernier@univ-tours.fr.'}, {'ForeName': 'Bairbre', 'Initials': 'B', 'LastName': 'McNicholas', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, School of Medicine, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Pavlov', 'Affiliation': 'Department of Emergency Medicine, Hopital de Verdun, Montreal, Quebec, Canada.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Roca', 'Affiliation': ""Critical Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Barcelona, Catalunya, Spain.""}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Perez', 'Affiliation': ""Médecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, CHU Tours, Tours, Centre, France.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Laffey', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, School of Medicine, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mirza', 'Affiliation': 'Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cosgrave', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, School of Medicine, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vines', 'Affiliation': 'Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'Réanimation Médicale, CHU Poitiers, Poitiers, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Médecin Intensive Réanimation, CIC 1415, CRICS-TriggerSEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, CHU Tours, Tours, Centre, France.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA.'}]",BMJ open,['10.1136/bmjopen-2020-041520']
1776,33177265,Dramatic Performance by a Professional Actor for the Treatment of Patients with Behavioral and Psychological Symptoms of Dementia.,"Behavioral and psychological symptoms of dementia (BPSD) challenge caregivers, leading to caregiver burden and subsequent nursing home or inpatient placement in a psychiatric hospital for dementia. Favorable positive emotions should be an important goal for the treatment of negative emotions of BPSD. Arts are one of the most profound areas to stimulate favorable emotions. We have asked a professional actor, who was not involved in the daily care and regular rehabilitations, to give a dramatic performance by reading selected stories as if the patients with BPSD felt to be in the audiences of a theater. We wondered whether a dramatic performance by the actor might be a way to respond to the complex needs of inpatients with BPSD, especially focused on favorable emotions. New inpatients (Alzheimer's disease, vascular dementia, or dementia with Lewy bodies) were randomly assigned to a control group (n = 20) and a dramatic performance group (n = 14) in Sendai Tomizawa Hospital, a psychiatric hospital for dementia, in Japan. Dramatic performances were performed for one and half hours once per week for 3 months. Neuropsychiatric Inventory for BPSD decreased in both groups and delightful emotional index (DEI) for favorable emotions increased in the intervention group but not in the control group after 3 months. At 3 months, there was an increase of DEI in intervention group compared with control group. We conclude that dramatic performance may be one of the appropriate interventions in patients with BPSD, as it appears to help in their favorable emotional state.",2020,Neuropsychiatric Inventory for BPSD decreased in both groups and delightful emotional index (DEI) for favorable emotions increased in the intervention group but not in the control group after 3 months.,"['patients with BPSD', 'group (n = 14) in Sendai Tomizawa Hospital, a psychiatric hospital for dementia, in Japan', 'dementia (BPSD) challenge caregivers, leading to caregiver burden and subsequent nursing home or inpatient placement in a psychiatric hospital for dementia', 'Patients with Behavioral and Psychological Symptoms of Dementia', ""New inpatients (Alzheimer's disease, vascular dementia, or dementia with Lewy bodies""]",['dramatic performance'],"['delightful emotional index (DEI) for favorable emotions', 'Neuropsychiatric Inventory for BPSD', 'DEI', 'Dramatic Performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}]",20.0,0.0339438,Neuropsychiatric Inventory for BPSD decreased in both groups and delightful emotional index (DEI) for favorable emotions increased in the intervention group but not in the control group after 3 months.,"[{'ForeName': 'Yusaku', 'Initials': 'Y', 'LastName': 'Maeda', 'Affiliation': 'Sendai Tomizawa Hospital.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Fukushima', 'Affiliation': 'Sendai Tomizawa Hospital.'}, {'ForeName': 'Satomi', 'Initials': 'S', 'LastName': 'Kyoutani', 'Affiliation': 'Sendai Tomizawa Hospital.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Butler', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Fujii', 'Affiliation': 'Sendai Tomizawa Hospital.'}, {'ForeName': 'Hidetada', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Sendai Tomizawa Hospital.'}]",The Tohoku journal of experimental medicine,['10.1620/tjem.252.263']
1777,33179398,Co-transplantation of bone marrow-derived mesenchymal stem cells with hematopoietic stem cells does not improve transplantation outcome in class III beta-thalassemia major: A prospective cohort study with long-term follow-up.,"Bone marrow transplantation is the only curative treatment for beta-thalassemia major. Data on the co-transplantation of MSCs with HSCs in beta-thalassemia major patients are scarce. We aimed to investigate the outcomes of thalassemia major patients who underwent bone marrow-derived MSC co-transplantation with HSCs compared with those who only received HSCs. This prospective randomized study included patients with class III thalassemia major undergoing HSCT divided randomly into two groups: Thirty-three patients underwent co-transplantation of bone marrow-derived MSCs with HSCs, and 26 patients only received HSCs. Five-year OS, TFS, TRM, graft rejection rate, and GVHD were estimated. The 5-year OS was 66.54% (95% CI, 47.8% to 79.9%) in patients who underwent co-transplantation of MSCs with HSCs vs 76.92% (95% CI, 55.7% to 88.9%) in patients who only received HSCs (P = .54). No significant difference was observed in the 5-year TFS between the two groups (59.1% vs 69.2%; P = .49). The 5-year cumulative incidence of TRM was not statistically significant among patients who underwent co-transplantation of MSCs with HSCs (27.27%) vs those who only received HSCs (19.23%; P = .61). There was no statistically significant difference in graft rejection, acute GvHD, and chronic GvHD between the two groups. Based on our findings, the co-transplantation of MSCs and HSCs to class III thalassemia major patients does not alter their transplantation outcomes including OS, TFS, rejection rate, transplant-related mortality, and GvHD.",2020,"There was no statistically significant difference in graft rejection, acute GvHD, and chronic GvHD between the two groups.","['class III beta-thalassemia major', 'thalassemia major patients who underwent bone marrow-derived MSC co-transplantation with HSCs compared with those who only received HSCs', 'patients with class III thalassemia major undergoing HSCT divided randomly into two groups: Thirty-three patients underwent']","['Bone marrow transplantation', 'Co-transplantation of bone marrow-derived mesenchymal stem cells with hematopoietic stem cells', 'co-transplantation of bone marrow-derived MSCs with HSCs, and 26 patients only received HSCs']","['5-year OS', 'graft rejection, acute GvHD, and chronic GvHD', '5-year cumulative incidence of TRM', '5-year TFS', 'TFS, TRM, graft rejection rate, and GVHD', 'OS, TFS, rejection rate, transplant-related mortality, and GvHD']","[{'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018133', 'cui_str': 'Graft versus host disease'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0178501,"There was no statistically significant difference in graft rejection, acute GvHD, and chronic GvHD between the two groups.","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Rostami', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasrollah', 'Initials': 'N', 'LastName': 'Maleki', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Kasaeian', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nikbakht', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Kiumarsi', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Asadollah Mousavi', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ardeshir', 'Initials': 'A', 'LastName': 'Ghavamzadeh', 'Affiliation': 'Hematology, Oncology and Stem Cell Transplantation Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Pediatric transplantation,['10.1111/petr.13905']
1778,33181658,Comparison of locking plates and intramedullary nails in treatment of three-part or four-part proximal humeral neck fractures in elderly population: A randomized trial protocol.,"BACKGROUND


Locking plate and intramedullary nail are two commonly applied methods to fix proximal humeral fractures. There are limited randomized studies that specifically evaluate the results of proximal humeral neck fractures with three-part or four-part treated by locking plates or intramedullary nails. Our goal was to compare functional outcomes, complications, and imaging features between the two groups.
METHODS


This single-center, prospective, randomized controlled test will be conducted in Tengzhou Central People's Hospital. Patients with these conditions will be included: age between 55 and 80 years; are able to communicate normally and agree to participate in our study; with the radiological evidence of proximal humeral fractures with three-part or four-part; surgical treatment was performed within twenty-one days after the acute fracture. Consecutive patients with proximal humeral fractures will be stochastic to be dealt with a locking plate or a bone nail. The informed consent will be acquired in each patients. Two groups will use the same postoperative rehabilitation protocol. Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications. The significance level was defaulted as P < .05.
RESULTS


This study will provide a solid theoretical basis for exploring which technique is better in treatment of 3-part or 4-part proximal humeral neck fractures in elderly population.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (number: researchregistry6047).",2020,"Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications.","['three-part or four-part proximal humeral neck fractures in elderly population', 'Consecutive patients with proximal humeral fractures', 'Patients with these conditions will be included: age between 55 and 80 years', ""Tengzhou Central People's Hospital"", '3-part or 4-part proximal humeral neck fractures in elderly population']","['locking plates or intramedullary nails', 'Locking plate and intramedullary nail', 'locking plate or a bone nail', 'locking plates and intramedullary nails']","['Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications', 'functional outcomes, complications, and imaging features', 'proximal humeral neck fractures']","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0262414', 'cui_str': 'Fracture of cervical spine'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0175718', 'cui_str': 'Bone pin'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0262414', 'cui_str': 'Fracture of cervical spine'}]",,0.0615174,"Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'School of Medicine, Shandong University.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Tengzhou Central People's Hospital.""}, {'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Orthopaedics, Tengzhou Central People's Hospital.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Orthopaedics, Shandong Provincial Hospital Affiliated to Shandong University, Shandong, China.'}]",Medicine,['10.1097/MD.0000000000022914']
1779,33181659,"Efficacy and safety of Hominis placenta pharmacopuncture on mild cognitive impairment: Randomized, double blind, placebo-controlled, multi-center trial.","INTRODUCTION


Mild cognitive impairment (MCI) is cognitive decline which can be observed in a wide range of cognitive domains. It is considered as a prodromal stage of dementia; therefore, strategies for treatment are necessary, but current evidence is limited. Combining the memory enhancing effect of Hominis placenta (H placenta) and acupuncture elucidated separately in previous studies, efficacy of H placenta pharmacopuncture for treating MCI is anticipated.
METHODS


Thirty participants will be recruited. Male and female adults aged 50 to 80 who voluntarily participate in the trial, are diagnosed with MCI according to diagnostic and statistical manual of mental disorders-5 criteria, and have a Clinical Dementia Rating score 0.5 will be enrolled. Participants who meet the criteria will be randomly allocated to either pharmacopuncture group or control group. Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment. Primary outcome will be difference in mean change of Korean version of Montreal Cognitive Assessment scores between intervention group and control group. Cognition, mood, sleep quality and quality of life will be also assessed using other neuropsychological tests and questionnaires regarding depression, anxiety, sleep and quality of life.
DISCUSSION


Evaluating the efficacy and safety data obtained by assessing diverse aspects of patients with MCI will broaden the scope of MCI management and prevention of dementia progression.
TRIAL REGISTRATION


Clinical Research Information Service (KCT0005368), Registered 02 Sep 2020, https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16425.",2020,"Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment.","['Thirty participants will be recruited', 'Male and female adults aged 50 to 80 who voluntarily participate in the trial, are diagnosed with MCI according to diagnostic and statistical manual of mental disorders-5 criteria, and have a Clinical Dementia Rating score 0.5 will be enrolled', 'mild cognitive impairment', 'patients with MCI']","['pharmacopuncture group or control group', 'placebo', 'Hominis placenta (H placenta', 'Hominis placenta pharmacopuncture']","['mean change of Korean version of Montreal Cognitive Assessment scores', 'neuropsychological tests and questionnaires regarding depression, anxiety, sleep and quality of life', 'Efficacy and safety', 'Cognition, mood, sleep quality and quality of life']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4304227', 'cui_str': 'CDR (Clinical Dementia Rating) score'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4279921', 'cui_str': 'Pharmacopuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458975', 'cui_str': 'Hominy'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.230275,"Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment.","[{'ForeName': 'Yunna', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'College of Korean Medicine.'}, {'ForeName': 'Jae Hyok', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Semyung University.'}, {'ForeName': 'In Chul', 'Initials': 'IC', 'LastName': 'Jung', 'Affiliation': 'Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Yoon Ji', 'Initials': 'YJ', 'LastName': 'Eom', 'Affiliation': 'College of Korean Medicine.'}, {'ForeName': 'Seung-Hun', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'College of Korean Medicine.'}]",Medicine,['10.1097/MD.0000000000022956']
1780,33181664,Acupoint injection versus sacral canal injection in lumbar disc herniation: A protocol of randomized controlled trial.,"BACKGROUND


Both acupoint injection and sacral canal injection are widely adopted in the treatment of lumbar disc herniation (LDH), but there are still doubts about the effectiveness and safety of the 2 methods. Therefore, the objective of the randomized controlled trial is to evaluate the effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH.
METHOD


This is a prospective randomized controlled trial to study the effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH. With the approval by the clinical research ethics committee of our hospital, patients were randomly included into 1 of 2 treatment protocols:Patients, doctors, nurses, and research assistants responsible for collecting data were blinded to group allocation. Main outcome observation indicator: visual analogue scale; secondary outcome observation indicator: Oswestry disability index scores; paresthesia score; adverse reactions. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).
DISCUSSION


The effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH were evaluated in this study, and the results of this trial would establish clinical evidence for the adoption of acupoint injection or sacral canal injection to treat LDH.
TRIAL REGISTRATION NUMBER


DOI 10.17605 / OSF.IO / VTFUD.",2020,"The effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH were evaluated in this study, and the results of this trial would establish clinical evidence for the adoption of acupoint injection or sacral canal injection to treat LDH.
","['lumbar disc herniation (LDH', 'lumbar disc herniation']","['Acupoint injection versus sacral canal injection', 'acupoint injection and sacral canal injection']","['disability index scores; paresthesia score; adverse reactions', 'effectiveness and safety']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0223605', 'cui_str': 'Sacral canal'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.176183,"The effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH were evaluated in this study, and the results of this trial would establish clinical evidence for the adoption of acupoint injection or sacral canal injection to treat LDH.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""The People's Hospital of Dazu District, Dazu, Chongqing, China.""}, {'ForeName': 'Huaying', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Yaokai', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023000']
1781,33181669,"Establishing a novel prognostic tool for Ewing sarcoma patients: Surveillance, Epidemiology, and End Results database analysis.","Patients diagnosed with Ewing sarcoma (ES) usually experience poor outcomes. Accurate prediction of ES patients' prognosis is essential to improve their survival. Given that ES is a relatively rare tumor with a low incidence, we aim at developing a prognostic nomogram of ES patients based on a large sample analysis.We used the Surveillance, Epidemiology, and End Results (SEER) database to screen eligible patients diagnosed ES of bone. This retrospective study presented the clinicopathological characteristics and prognosis of ES. We randomly assigned all ES patients to 2 sets (training set and validation set) with an equal number of patients. In order to identify independent factors of survival, we performed univariate and multivariate Cox analysis in the training set. Then, we constructed novel nomograms to predict survival of ES patients by integrating significant independent variables from the training set. The prognostic performance of constructed nomograms was examined using concordance index (C-index) and calibration curves in both training and validation set.We included a total of 988 eligible cases diagnosed ES of bone between 2000 and 2015. Age >18 years, distant metastasis, tumor size >10 cm, and no surgery were independent risk factors for poorer survival. Our survival prediction nomograms were established based on those 4 independent risk factors. Good calibration plots were achieved in internal and external validation. The internal validation C-indexes of the nomogram for overall survival (OS) and cancer-specific survival (CSS) were 0.733 and 0.737, respectively. Similar good results were also achieved in external validation setting.The established nomograms show good performance and allow for better evaluating the prognosis of ES patients and recommending appropriate instructions.",2020,"The internal validation C-indexes of the nomogram for overall survival (OS) and cancer-specific survival (CSS) were 0.733 and 0.737, respectively.","['screen eligible patients diagnosed ES of bone', 'Patients diagnosed with Ewing sarcoma (ES', 'Ewing sarcoma patients', '988 eligible cases diagnosed ES of bone between 2000 and 2015']",['ES'],"['overall survival (OS) and cancer-specific survival (CSS', 'concordance index (C-index) and calibration curves']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1704327', 'cui_str': 'Sarcoma of bone'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C1261473', 'cui_str': 'Sarcoma'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",988.0,0.0479951,"The internal validation C-indexes of the nomogram for overall survival (OS) and cancer-specific survival (CSS) were 0.733 and 0.737, respectively.","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""Department of Orthopaedics, The Affiliated Yangming Hospital of Ningbo University, Yuyao People's Hospital of Zhejiang Province, Yuyao.""}, {'ForeName': 'Yuanxi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopaedics, Health Community Group of Yuhuan Second People's Hospital, Yuhuan.""}, {'ForeName': 'Renbo', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopaedics, Taizhou Tumor Hospital, Wenling, Zhejiang, China.'}, {'ForeName': 'Yingqing', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': ""Department of Orthopaedics, The Affiliated Yangming Hospital of Ningbo University, Yuyao People's Hospital of Zhejiang Province, Yuyao.""}]",Medicine,['10.1097/MD.0000000000023050']
1782,33181672,Intelligent rehabilitation assistant system to promote the early functional recovery of the elderly patients with femoral neck fracture after hemiarthroplasty (HA): A protocol for a randomized controlled trial.,"BACKGROUND


Femoral neck fracture is a common type of hip fracture, which has a high morbidity and mortality. Surgical treatment is the first choice. However, the functional rehabilitation after operation has not been paid enough attention. In addition, the quality of exercise is difficult to quantify, and the rehabilitation is lack of standards. Therefore, the intelligent rehabilitation assistant system which could record exercise details, might be used to evaluate the quality and adherence to the prescribed exercise to this fragile group of patients has great relevance, so as to provide new ideas for postoperative rehabilitation of hip fracture.
METHODS


This is an opening, prospective, double-dummy RCT. Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study. The sample will be divided into monitoring group and control group randomly at a 1:1 ratio. The prescribed exercises need to be done continuously for 2 weeks. The monitoring group needs additional use intelligent rehabilitation assistant system. Each subject will receive a total of 4 follow-up visits at the designated time (2 weeks, 4 weeks, 12 weeks, and 24 weeks). The following factors will be talked as dependent variables:Each subject will receive a total of 4 follow-up visits at the designated time, and the findings will be analyzed statistically considering a 5% significance level (P < .05).
DISCUSSION


Exercise under monitor may improve patients compliance and exercise quality, and accelerate the rehabilitation process. This protocol reported in accordance with the CONSORT 2010 checklist and SPIRIT 2013 Checklist.
TRIAL REGISTRATION


The trial is registered at Chinese Clinical Trials Registry (ChiCTR2000033213, May 24, 2020).",2020,"Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study.","['elderly patients with femoral neck fracture after hemiarthroplasty (HA', 'Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA']",['Intelligent rehabilitation assistant system'],['patients compliance and exercise quality'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3874886', 'cui_str': 'Is about'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",50.0,0.070336,"Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study.","[{'ForeName': 'Zige', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Haixiong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Minling', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}]",Medicine,['10.1097/MD.0000000000023078']
1783,33185376,"The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics: A Randomized, Controlled Trial.","BACKGROUND


Changes in local anesthetics temperature may influence the characters of the peripheral nerve block. The effect of warmed bupivacaine on supraclavicular brachial plexus block has not yet been evaluated.
OBJECTIVES


This study was designed to evaluate the influence of warming bupivacaine 0.5% on the characteristics of supraclavicular plexus block in adult patients undergoing orthopedic surgery below the mid-arm. The primary objective was the time to onset of sensory block. The secondary objectives were the time to onset of motor block, the duration of sensory and motor blocks, and the time to the first analgesic requirement.
STUDY DESIGN


Randomized, double-blind, controlled trial.
SETTING


University hospital setting.
METHODS


Ninety patients who underwent elective or emergency orthopedic surgery below the mid-arm were included in this study. Patients were randomly allocated into 2 groups and received ultrasound-guided supraclavicular brachial plexus block. Group I received 30 mL 0.5% bupivacaine at 23°C. Group II received 30 mL bupivacaine 0.5% warmed to 37°C. The onset of sensory and motor blocks, postoperative pain severity, the duration of sensory and motor blocks, and the time to the first analgesic requirement were evaluated in all patients.
RESULTS


The warm bupivacaine group had a significantly accelerated onset time of sensory and motor block. The duration of sensory and motor block and the time to first requirement for analgesia were significantly longer in the warm bupivacaine group. Moreover, it significantly reduced the postoperative analgesics consumption.
LIMITATIONS


Postoperative assessment of the offset of the sensory and motor blocks of the individualized nerves was inaccessible, in addition to a small sample size.
CONCLUSIONS


Warming bupivacaine 0.5% to 37°C improves the characteristics of supraclavicular plexus block. It promotes rapid onset of sensory-motor block and provided better quality of postoperative analgesia.",2020,The duration of sensory and motor block and the time to first requirement for analgesia were significantly longer in the warm bupivacaine group.,"['University hospital setting', 'adult patients undergoing orthopedic surgery below the mid-arm', 'Ninety patients who underwent elective or emergency orthopedic surgery below the mid-arm were included in this study', 'Supraclavicular Plexus Block Characteristics']","['bupivacaine', '30 mL bupivacaine', 'Bupivacaine Temperature', 'ultrasound-guided supraclavicular brachial plexus block', 'warmed bupivacaine', '30 mL 0.5% bupivacaine']","['onset of sensory and motor blocks, postoperative pain severity, the duration of sensory and motor blocks, and the time to the first analgesic requirement', 'postoperative analgesics consumption', 'characteristics of supraclavicular plexus block', 'duration of sensory and motor block and the time to first requirement for analgesia', 'time to onset of motor block, the duration of sensory and motor blocks, and the time to the first analgesic requirement', 'onset time of sensory and motor block', 'time to onset of sensory block']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0584885', 'cui_str': 'Local anesthetic block of nerve plexus'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0584885', 'cui_str': 'Local anesthetic block of nerve plexus'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}]",90.0,0.189828,The duration of sensory and motor block and the time to first requirement for analgesia were significantly longer in the warm bupivacaine group.,"[{'ForeName': 'Mohamed Younis', 'Initials': 'MY', 'LastName': 'Makharita', 'Affiliation': 'Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Shimaa Abd El-Satar', 'Initials': 'SAE', 'LastName': 'Shalaby', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hosam I El Said', 'Initials': 'HIES', 'LastName': 'Saber', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hanaa M', 'Initials': 'HM', 'LastName': 'El Bendary', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Pain physician,[]
1784,33185393,"RE: ""A Prospective, Randomized Cross-Over Trial of T2 Paravertebral Block as a Sympathetic Block in Complex Regional Pain Syndrome (CRPS)"".",,2020,,[],['T2 Paravertebral Block'],[],[],"[{'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",[],,0.0214571,,"[{'ForeName': 'Rajput Abhishek', 'Initials': 'RA', 'LastName': 'Kumar', 'Affiliation': 'Pain and Palliative Care Medicine, Department of Anaesthesiology, Sanjay Gandhi Post Graduate In¬stitute of Medical Sciences Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Pain Clinic, Department of Anaesthesia, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, India.'}, {'ForeName': 'Sujeet Kumar Singh', 'Initials': 'SKS', 'LastName': 'Gautam', 'Affiliation': 'Pain Clinic, Department of Anaesthesia, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Uttar Pradesh, India.'}]",Pain physician,[]
1785,33185468,"A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder.","Objectives:  In a previous pivotal study of children and adolescents (aged 6-17 years) with attention-deficit/hyperactivity disorder (ADHD), dose-optimized SHP465 mixed amphetamine salts (MAS) extended-release (12.5-25 mg once daily) was superior to placebo in reducing ADHD symptoms. This study evaluated the efficacy, tolerability, and safety of 6.25 mg SHP465 MAS once daily (one-half the lowest approved dose for adolescents and adults) versus placebo in children aged 6-12 years with ADHD.  Methods:  Children (aged 6-12 years) with Diagnostic and Statistical Manual of Mental Disorders, Fifth edition-defined ADHD; baseline ADHD-Rating Scale, Fifth Edition, Child, Home Version total scores (ADHD-RS-5-HV-TS) ≥28; and baseline Clinical Global Impressions-Severity scores ≥4 were eligible. Participants received 6.25 mg SHP465 MAS once daily or placebo for 4 weeks. The primary (ADHD-RS-5-HV-TS change from baseline at week 4) and key secondary (Clinical Global Impressions-Improvement [CGI-I] score at week 4) efficacy end points were assessed using linear mixed-effects models for repeated measures. Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and vital sign changes.  Results:  Of 89 randomized participants, 83 completed the study (placebo,  n  = 41; SHP465 MAS,  n  = 42). At week 4, the least squares mean (95% confidence interval) treatment differences (SHP465 MAS-placebo) were not statistically significant for ADHD-RS-5-HV-TS change (-1.9 [-6.8 to 3.1],  p  = 0.451; effect size [ES] = 0.17) or CGI-I score (-0.1 [-0.5 to 0.3], nominal  p  = 0.597; ES = 0.12). The percentage of participants reporting TEAEs was 16.3% with placebo and 24.4% with SHP465 MAS. The most frequently reported TEAEs (placebo; SHP465 MAS) were headache (7.0%; 4.4%) and decreased appetite (4.7%; 2.2%). Minimal increases in blood pressure were observed with SHP465 MAS at the final on-treatment assessment.  Conclusions:  SHP465 MAS 6.25 mg once daily (one-half the lowest dose approved for adolescents and adults) was well tolerated in children aged 6-12 years but was not superior to placebo in reducing ADHD symptoms, suggesting that this dose of SHP465 MAS was subtherapeutic in this age group. The Clinical Trial Registration number: NCT03325881.",2020,Minimal increases in blood pressure were observed with SHP465 MAS at the final on-treatment assessment.  ,"['adolescents and adults', '89 randomized participants, 83 completed the study (placebo,  n \u2009=\u200941; SHP465 MAS,  n \u2009=\u200942', 'children aged 6-12 years with ADHD', 'Methods:  Children (aged 6-12 years) with Diagnostic and Statistical Manual of Mental Disorders, Fifth edition-defined ADHD; baseline ADHD-Rating Scale, Fifth Edition, Child, Home Version total scores (ADHD-RS-5-HV-TS) ≥28; and baseline Clinical Global Impressions-Severity scores ≥4 were eligible', 'children and adolescents (aged 6-17 years) with attention-deficit/hyperactivity disorder (ADHD), dose-optimized', 'Children with Attention-Deficit/Hyperactivity Disorder']","['SHP465 MAS', 'SHP465 MAS once daily or placebo', 'SHP465 mixed amphetamine salts (MAS', 'placebo', 'Low-Dose SHP465 Mixed Amphetamine Salts']","['headache', 'blood pressure', 'ADHD-RS-5-HV-TS change', 'efficacy, tolerability, and safety', 'appetite', 'Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and vital sign changes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",89.0,0.43614,Minimal increases in blood pressure were observed with SHP465 MAS at the final on-treatment assessment.  ,"[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Mattingly', 'Affiliation': 'Midwest Research Group, St. Charles, Missouri, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arnold', 'Affiliation': 'CNS Healthcare, Memphis, Tennessee, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Biostatistics, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Global Clinical Development, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Global Clinical Development, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0005']
1786,33185527,"The effect of 0.5% topical timolol cream on regression of superficial infantile haemangioma in the involuting phase: a prospective, randomized, self-controlled study.","BACKGROUND


Infantile haemangiomas are the most common benign tumours affecting infants. Over time, the tumours may involute to some extent. However, sequelae, such as telangiectasia or fibrofatty tissue, often occur following this condition, which may cause disfigurement and influence patients' psychosocial development.
OBJECTIVE


This prospective, randomized, self-controlled study aimed to assess the effects of topical timolol (0.5%) on involuting infantile haemangiomas.
MATERIALS & METHODS


Each involuting superficial infantile haemangioma (n = 29) was randomly divided into two regions; one region was treated with topical timolol (0.5%) cream, three times daily, and the other region was untreated. The comparative treatments continued for three months. Five independent assessors, blinded to the treatment regimen, judged the treated and untreated regions by comparing photographs before and after treatment.
RESULTS


The topical timolol-treated tumour sections showed no difference compared with the untreated sites (p = 0.355) after three months of treatment, and by the end of the treatment, the untreated lesions showed significant differences relative to pre-treatment (p<0.001).
CONCLUSION


Topical timolol was not observed to have any effect on the regression of infantile haemangiomas in the involuting phase.",2020,"The topical timolol-treated tumour sections showed no difference compared with the untreated sites (p = 0.355) after three months of treatment, and by the end of the treatment, the untreated lesions showed significant differences relative to pre-treatment (p<0.001).
",['Each involuting superficial infantile haemangioma (n = 29'],"['topical timolol cream', 'Topical timolol', 'topical timolol']",['superficial infantile haemangioma'],"[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}]",29.0,0.0273909,"The topical timolol-treated tumour sections showed no difference compared with the untreated sites (p = 0.355) after three months of treatment, and by the end of the treatment, the untreated lesions showed significant differences relative to pre-treatment (p<0.001).
","[{'ForeName': 'Hanru', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Zongan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shihjen', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}]",European journal of dermatology : EJD,['10.1684/ejd.2020.3708']
1787,33185560,Once Daily Versus Overnight and Symptom Versus Physiological Monitoring to Detect Exacerbations of Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.,"BACKGROUND


Earlier detection of chronic obstructive pulmonary disease (COPD) exacerbations may facilitate more rapid treatment with reduced risk of hospitalization. Changes in pulse oximetry may permit early detection of exacerbations. We hypothesized that overnight pulse oximetry would be superior to once-daily monitoring for the early detection of exacerbations.
OBJECTIVE


This study aims to evaluate whether measuring changes in heart rate and oxygen saturation overnight is superior to once-daily monitoring of both parameters and to assess symptom changes in facilitating earlier detection of COPD exacerbations.
METHODS


A total of 83 patients with COPD were randomized to once-daily or overnight pulse oximetry. Both groups completed the COPD assessment test questionnaire daily. The baseline mean and SD for each pulse oximetry variable were calculated from 14 days of stable monitoring. Changes in exacerbation were expressed as Z scores from this baseline.
RESULTS


The mean age of the patients was 70.6 (SD 8.1) years, 52% (43/83) were female, and the mean FEV1 was 53.0% (SD 18.5%) predicted. Of the 83 patients, 27 experienced an exacerbation. Symptoms were significantly elevated above baseline from 5 days before to 12 days after treatment initiation. Day-to-day variation in pulse oximetry during the stable state was significantly less in the overnight group than in the once-daily group. There were greater relative changes at exacerbation in heart rate than oxygen saturation. An overnight composite score of change in heart rate and oxygen saturation changed significantly from 7 days before initiation of treatment for exacerbation and had a positive predictive value for exacerbation of 91.2%. However, this was not statistically better than examining changes in symptoms alone.
CONCLUSIONS


Overnight pulse oximetry permits earlier detection of COPD exacerbations compared with once-daily monitoring. Monitoring physiological variables was not superior to monitoring symptoms, and the latter would be a simpler approach, except where there is a need for objective verification of exacerbations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03003702; https://clinicaltrials.gov/ct2/show/NCT03003702.",2020,An overnight composite score of change in heart rate and oxygen saturation changed significantly from 7 days before initiation of treatment for exacerbation and had a positive predictive value for exacerbation of 91.2%.,"['83 patients with COPD', 'Chronic Obstructive Pulmonary Disease', '83 patients, 27 experienced an exacerbation', 'chronic obstructive pulmonary disease (COPD) exacerbations']","['Once Daily Versus Overnight and Symptom Versus Physiological Monitoring', 'Overnight pulse oximetry', 'overnight pulse oximetry']","['mean FEV1', 'COPD exacerbations', 'heart rate and oxygen saturation', 'COPD assessment test questionnaire daily', 'pulse oximetry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026429', 'cui_str': 'Physiologic Monitoring'}, {'cui': 'C0430630', 'cui_str': 'Overnight pulse oximetry'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}]",83.0,0.690075,An overnight composite score of change in heart rate and oxygen saturation changed significantly from 7 days before initiation of treatment for exacerbation and had a positive predictive value for exacerbation of 91.2%.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Al Rajeh', 'Affiliation': 'Department of respiratory care, King Faisal University, Al-Ahsa, Saudi Arabia.'}, {'ForeName': 'Yousef Saad', 'Initials': 'YS', 'LastName': 'Aldabayan', 'Affiliation': 'Department of respiratory care, King Faisal University, Al-Ahsa, Saudi Arabia.'}, {'ForeName': 'Abdulelah', 'Initials': 'A', 'LastName': 'Aldhahir', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Pickett', 'Affiliation': 'Department of respiratory medicine, Royal Free London NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Shumonta', 'Initials': 'S', 'LastName': 'Quaderi', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Jaber S', 'Initials': 'JS', 'LastName': 'Alqahtani', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Mandal', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Marc Ci', 'Initials': 'MC', 'LastName': 'Lipman', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hurst', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/17597']
1788,33192570,Slow-Paced Breathing and Autonomic Function in People Post-stroke.,"Purpose : To determine if acute slow breathing at 6 breaths/min would improve baroreflex sensitivity (BRS) and heart rate variability (HRV), and lower blood pressure (BP) in adults after stroke.  Methods : Twelve individuals completed two randomized study visits where they performed a 15-min bout of breathing exercises at 6 breaths/min (slow) and at 12 breaths/min (control). Continuous BP and heart rate (HR) were measured throughout, and BRS, BRS response to elevations in blood pressure (BRSup), BRS response to depressions in blood pressure (BRSdown), and HRV were calculated and analyzed before (pre), during, and after (post) breathing exercises.  Results : BRS increased from pre to post slow breathing by 10% ( p  = 0.012), whereas BRSup increased from pre to during slow breathing by 30% ( p  = 0.04). BRSdown increased from pre to post breathing for both breathing conditions ( p  < 0.05). HR (control:  Δ  - 4 ± 4; slow:  Δ  - 3 ± 4 beats/min, time,  p  < 0.01) and systolic BP (control:  Δ  - 0.5 ± 5; slow:  Δ  - 6.3 ± 8 mmHg, time,  p  < 0.01) decreased after both breathing conditions. Total power, low frequency power, and standard deviation of normal inter-beat intervals (SDNN) increased during the 6-breaths/min condition (condition × time,  p  < 0.001), whereas high frequency increased during both breathing conditions (time effect,  p  = 0.009).  Conclusions : This study demonstrated that in people post-stroke, slow breathing may increase BRS, particularly BRSup, more than a typical breathing space; however, paced breathing at either a slow or typical breathing rate appears to be beneficial for acutely decreasing systolic BP and HR and increasing HRV.",2020,"Results : BRS increased from pre to post slow breathing by 10% ( p  = 0.012), whereas BRSup increased from pre to during slow breathing by 30% ( p  = 0.04).","['People Post-stroke', 'adults after stroke']","['breathing exercises at 6 breaths/min (slow) and at 12 breaths/min (control', 'HR (control']","['BRS', 'baroreflex sensitivity (BRS) and heart rate variability (HRV), and lower blood pressure (BP', 'Slow-Paced Breathing and Autonomic Function', 'BRSup', 'systolic BP (control', 'BRS, BRS response to elevations in blood pressure (BRSup), BRS response to depressions in blood pressure (BRSdown), and HRV', 'systolic BP and HR and increasing HRV', 'Continuous BP and heart rate (HR', 'Total power, low frequency power, and standard deviation of normal inter-beat intervals (SDNN', 'BRSdown']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0326567,"Results : BRS increased from pre to post slow breathing by 10% ( p  = 0.012), whereas BRSup increased from pre to during slow breathing by 30% ( p  = 0.04).","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Larson', 'Affiliation': 'Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Chantigian', 'Affiliation': 'Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Ninitha', 'Initials': 'N', 'LastName': 'Asirvatham-Jeyaraj', 'Affiliation': 'Indian Institute of Science, Bangalore, India.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van de Winckel', 'Affiliation': 'Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, University of Minnesota, Minneapolis, MN, United States.'}, {'ForeName': 'Manda L', 'Initials': 'ML', 'LastName': 'Keller-Ross', 'Affiliation': 'Division of Rehabilitation Science, Department of Rehabilitation Medicine, Medical School, University of Minnesota, Minneapolis, MN, United States.'}]",Frontiers in physiology,['10.3389/fphys.2020.573325']
1789,33192574,Fetuin-A as a Potential Biomarker of Metabolic Variability Following 60 Days of Bed Rest.,"Background : Fetuin-A is a hepatokine linked to the development of insulin resistance. The purpose of this study was to determine if 60 days head-down-tilt (HDT) bed rest increased circulating fetuin-A and if it was linked to whole body insulin sensitivity (IS). Additionally, we examined whether reactive jump training (RJT) could alleviate the metabolic changes associated with bed rest.  Methods : 23 young men (29 ± 6 years, 181 ± 6 cm, 77 ± 7 kg) were randomized to a control (CTRL,  n  = 11) or RJT group (JUMP,  n  = 12) and exposed to 60 days of bed rest. Before and after bed rest, body composition and    V   .   O     2   ⁢   p   ⁢   e   ⁢   a   ⁢   k        were measured and an oral glucose tolerance test was performed to estimate IS. Circulating lipids and fetuin-A were measured in fasting serum.  Results : Body weight, lean mass, and    V   .   O     2   ⁢   p   ⁢   e   ⁢   a   ⁢   k        decreased in both groups following bed rest, with greater reductions in CTRL ( p  < 0.05). There was a main effect of time, but not the RJT intervention, for the increase in fetuin-A, triglycerides (TG), area under the curve for glucose (AUCG) and insulin (AUCI), and the decrease in Matsuda and tissue-specific IS ( p  < 0.05). Fetuin-A increased in participants who became less insulin sensitive ( p  = 0.019). In this subgroup, liver IS and adipose IS decreased ( p  < 0.05), while muscle IS was unchanged. In a subgroup, where IS did not decrease, fetuin-A did not change. Liver IS increased ( p  = 0.012), while muscle and adipose tissue IS remained unchanged.  Conclusions : In this study, we report an increase in circulating fetuin-A following 60 days of bed rest, concomitant with reduced IS, which could not be mitigated by RJT. The amount of fetuin-A released from the liver may be an important determinant of changes in whole body IS. In this regard, it may also be a useful biomarker of individual variation due to inactivity or lifestyle interventions.",2020,"In this subgroup, liver IS and adipose IS decreased ( p  < 0.05), while muscle IS was unchanged.","['Methods : 23 young men (29 ± 6 years, 181 ± 6 cm, 77 ± 7 kg']","['control (CTRL,  n  = 11) or RJT group (JUMP,  n  = 12) and exposed to 60 days of bed rest', 'e   \u2062   a   \u2062', 'reactive jump training (RJT', 'O     2   \u2062', '60 days head-down-tilt (HDT', ' ']","['fetuin-A, triglycerides (TG), area under the curve for glucose (AUCG) and insulin (AUCI', 'Matsuda and tissue-specific IS', 'liver IS and adipose IS', 'Results : Body weight, lean mass, and    V   ', 'Circulating lipids and fetuin-A', 'CTRL', 'k']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}]","[{'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",23.0,0.0458743,"In this subgroup, liver IS and adipose IS decreased ( p  < 0.05), while muscle IS was unchanged.","[{'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'Faculty of Science and Health, Athlone Institute of Technology, Athlone, Ireland.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Mulder', 'Affiliation': 'Department of Muscle and Bone Metabolism, Institute of Aerospace Medicine, German Aerospace Center (Deutsches Zentrum für Luft- und Raumfahrt, DLR), Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Frings-Meuthen', 'Affiliation': 'Department of Muscle and Bone Metabolism, Institute of Aerospace Medicine, German Aerospace Center (Deutsches Zentrum für Luft- und Raumfahrt, DLR), Cologne, Germany.'}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': ""O'Gorman"", 'Affiliation': '3U Diabetes Partnership, School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Faculty of Science and Health, Athlone Institute of Technology, Athlone, Ireland.'}]",Frontiers in physiology,['10.3389/fphys.2020.573581']
1790,33192634,"Melatonin Is a Feasible, Safe, and Acceptable Intervention in Doctors and Nurses Working Nightshifts: The MIDNIGHT Trial.","Nightshift working is associated with sleep deprivation, fatigue and attention/concentration deficits which, in healthcare workers, may impact on patient safety. Clinical staff in the UK routinely work several 12 h nightshifts in a row at about 1-3 month intervals. We investigated the feasibility and acceptability of a crossover trial of melatonin administration in clinical staff working nightshifts with an exploration of effects on sleep measures and attention/concentration tasks. This was a pilot, double-blinded, randomized, placebo-controlled crossover feasibility trial in doctors and nurses working 3 consecutive nightshifts at a tertiary referral hospital in the UK. Twenty five male and female subjects were randomized to receive either 6mg Circadin™ slow release melatonin or placebo before sleep after each consecutive nightshift, followed by a washout period, before crossing over to the other experimental arm. We used actigraphy for objective assessment of sleep parameters. The trial design was feasible and acceptable to participants with negligible side effects, but elevated melatonin levels were prolonged during the active arm (P=0.016). Double digit addition testing, a concentration/attention task, improved with melatonin treatment (P<0.0001). Lapses of vigilance or judgement while doctors or nurses are working nightshifts could impact on patient safety and melatonin may be a useful intervention. This study supports the conclusion that a larger definitive trial of this design is both feasible and safe.  Clinical Trial Registration:  identifier ISRCTN15529655. https://www.isrctn.com/.",2020,"Double digit addition testing, a concentration/attention task, improved with melatonin treatment (P<0.0001).","['doctors and nurses working 3 consecutive nightshifts at a tertiary referral hospital in the UK', 'Twenty five male and female subjects']","['melatonin', '6mg Circadin™ slow release melatonin or placebo', 'placebo', 'Melatonin']","['sleep measures and attention/concentration tasks', 'elevated melatonin levels']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.654297,"Double digit addition testing, a concentration/attention task, improved with melatonin treatment (P<0.0001).","[{'ForeName': 'Bensita M V J', 'Initials': 'BMVJ', 'LastName': 'Thottakam', 'Affiliation': 'Institute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Nigel R', 'Initials': 'NR', 'LastName': 'Webster', 'Affiliation': 'Institute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': 'Intensive Care Unit, Aberdeen Royal Infirmary, Aberdeen, United Kingdom.'}, {'ForeName': 'Malachy O', 'Initials': 'MO', 'LastName': 'Columb', 'Affiliation': 'Anaesthesia and Intensive Care Medicine, Manchester University Hospitals NHS Foundation Trust, Wythenshawe, United Kingdom.'}, {'ForeName': 'Helen F', 'Initials': 'HF', 'LastName': 'Galley', 'Affiliation': 'Institute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00872']
1791,33192637,Antenatal Depressive Symptoms and Neurodevelopment Outcomes in Children at 30 Months. A Study From South India.,"Background


Prevalence of antenatal depression in low and middle income countries is high. However studies examining the association between maternal antenatal depression and early childhood development from these countries are scarce. The objective of the study was to examine the association between antenatal depressive symptoms assessed serially during pregnancy and child neurodevelopment outcomes in mother-child dyads part of a randomized control trial of maternal B12 supplementation during pregnancy.
Method


Subjects were 203 women who had participated in the placebo-controlled, randomized trial of vitamin B12 supplementation during pregnancy and 6 weeks post-partum on whom serial assessments of depressive symptoms in each of the trimesters were available. Cognitive, receptive language, expressive language, fine motor skills and gross motor skills were assessed at 30 months using the Bayley's Scale of Infant Development-3rd edition (BSID-III). Antenatal depressive symptoms were assessed at three trimesters using the Kessler's 10 Psychological Distress Scale (K10). Women were classified into three categories: not depressed (K10 <6 in all trimesters), with intermittent depressive symptoms (K10 ≥6 in at least one trimester) and with persistent depressive symptoms (K10 score ≥6 in at least 2 trimesters).
Results


112 (55.2%) of the women did not have depressive symptoms, 58 (28.6%) had intermittent depressive symptoms and 33 (16.2%) had persistent depressive symptoms. The children of women with intermittent antenatal depressive symptoms scored lower on the receptive language domain on BSID-III compared to children of women who were not depressed on univariate analysis, but not on bivariate regression analysis. Women with persistent depressive symptoms had lower educational attainment (p = 0.004), lower social support (p = 0.006) and used more emotional coping strategies (p = 0.005) compared to the not depressed group.
Conclusions


A significant number of women in south India had antenatal depressive symptoms. Findings from this study suggest a possible association between antenatal depressive symptoms and receptive language in children. Larger studies including women with clinical depression are needed to confirm these findings.",2020,"Women with persistent depressive symptoms had lower educational attainment (p = 0.004), lower social support (p = 0.006) and used more emotional coping strategies (p = 0.005) compared to the not depressed group.
","['Children at 30 Months', 'women in south India had antenatal depressive symptoms', 'mother-child dyads', 'Method\n\n\nSubjects were 203 women who had participated in the', 'Women were classified into three categories: not depressed (K10 <6 in all trimesters), with intermittent depressive symptoms (K10 ≥6 in at least one trimester) and with persistent depressive symptoms (K10 score ≥6 in at least 2 trimesters', 'women with clinical depression', 'children']","['maternal B12 supplementation', 'vitamin B12 supplementation', 'placebo']","['persistent depressive symptoms', 'lower social support', 'Antenatal Depressive Symptoms and Neurodevelopment Outcomes', 'emotional coping strategies', 'intermittent depressive symptoms', 'depressive symptoms', 'Cognitive, receptive language, expressive language, fine motor skills and gross motor skills', 'receptive language domain on BSID-III', 'educational attainment', 'Antenatal depressive symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",203.0,0.0829491,"Women with persistent depressive symptoms had lower educational attainment (p = 0.004), lower social support (p = 0.006) and used more emotional coping strategies (p = 0.005) compared to the not depressed group.
","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Emelia', 'Initials': 'E', 'LastName': 'Vigil', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Division of Epidemiology, Biostatistics and Population Health, St John's Research Institute, Bengaluru, India.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bellinger', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Ramthal', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""Division of Nutrition, St John's Research Institute, Bengaluru, India.""}, {'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health & Neurosciences, St John's Research Institute, Bengaluru, India.""}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.486175']
1792,33192794,Effect of 1 Year of Qigong Exercise on Cognitive Function Among Older Chinese Adults at Risk of Cognitive Decline: A Cluster Randomized Controlled Trial.,"Background:  The rapidly aging Chinese population is showing an increase in age-related illnesses, including mild cognitive impairment and Alzheimer disease. The best types of physical activity for the improvement of cognition remain unknown. This study aimed to compare the effectiveness of a tailored qigong exercise with that of stretching exercise in the maintenance of cognitive abilities in Chinese elders at risk of cognitive decline.  Methods:  Seventy-four community-dwelling adults aged ≥60 years were screened for eligibility. Using a randomized control group design, participants with scores ≥19 on the Chinese version of the Montreal Cognitive Assessment-Basic (MoCA) were allocated to a 1-year qigong intervention ( n  = 33) and a stretching control exercise group ( n  = 33). The primary outcome was the MoCA score, as a measure of global cognitive function, and secondary outcomes were globe cognition and five domain scores on the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The MoCA and RBANS were administered at baseline and 1 year after intervention to assess the effect of the exercises on cognitive decline.  Results:  Twenty-five of 33 (75.8%) participants in the qigong group and 26 of 33 (78.8%) participants in the control group completed the 1-year exercise programs. A bivariate test revealed strong correlation between MoCA and RBANS total scores after the intervention ( r  = 0.517,  p  < 0.01). Generalized estimating equations revealed a lower risk of progression of cognitive decline at 1 year in the qigong group than in the control group (odds ratio, 0.314; 95% confidence interval, 0.103-0.961;  p  = 0.04). Two-way repeated-measures ANOVA followed by  post hoc t  tests with Bonferroni corrections indicated that MoCA and RBANS scores were significantly higher in the qigong group than in the control group (MoCA and RBANS global cognition, memory, visuospatial/constructional ability, and language, all  p  < 0.01), with the exception of RBANS attention score ( p  > 0.05).  Conclusions:  One year of qigong practice was significantly superior to stretching exercise not only for the prevention of cognitive decline progression, but also for the improvement of several cognitive functions, among older Chinese adults at risk of cognitive decline.",2020,"One year of qigong practice was significantly superior to stretching exercise not only for the prevention of cognitive decline progression, but also for the improvement of several cognitive functions, among older Chinese adults at risk of cognitive decline.","['Chinese elders at risk of cognitive decline', 'Older Chinese Adults at Risk of Cognitive Decline', 'Methods:  Seventy-four community-dwelling adults aged ≥60 years were screened for eligibility', 'older Chinese adults at risk of cognitive decline', 'participants with scores ≥19 on the Chinese version of the Montreal Cognitive Assessment-Basic (MoCA']","['1-year qigong intervention', 'Qigong Exercise', 'tailored qigong exercise', '1-year exercise programs', 'stretching exercise', 'stretching control exercise']","['Cognitive Function', 'MoCA and RBANS total scores', 'MoCA and RBANS scores', 'several cognitive functions', 'risk of progression of cognitive decline', 'RBANS attention score', 'RBANS global cognition, memory, visuospatial/constructional ability, and language', 'MoCA score, as a measure of global cognitive function, and secondary outcomes were globe cognition and five domain scores on the Chinese version of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]",,0.0833373,"One year of qigong practice was significantly superior to stretching exercise not only for the prevention of cognitive decline progression, but also for the improvement of several cognitive functions, among older Chinese adults at risk of cognitive decline.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Martial Arts, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Suhui', 'Initials': 'S', 'LastName': 'Jin', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Kinesiology, Boise State University, Boise, ID, United States.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Martial Arts, Shanghai University of Sport, Shanghai, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.546834']
1793,33192801,Play Mode Effect of Exergames on Subthreshold Depression Older Adults: A Randomized Pilot Trial.,"Background


Subthreshold depression is a common mental disorder in late life. Increasing studies have supported the positive effects of exergames to subthreshold depression. The current study aims to investigate how play mode potentially affects exergames' effects on subthreshold depression among older adults.
Method


A between-group experiment was carried out to compare the effect of exergames with different play modes. Fifty-two Singaporean older adults with subthreshold depression were randomly assigned into two conditions, and performed either single-player or multiple-player Nintendo Wii Tennis exergames for 6 weeks, while the key variables of depression, social support and loneliness were measured at both pre- and post-study period.
Results


Findings from path analysis suggested that older adults in multiple-player exergames experienced lower levels of loneliness, and further more reduction on subthreshold depression, when compared to those in single-player exergames. Although social support was not affected by play mode, the significant relationship among social support, loneliness, and depression was found in the context of exergaming.
Conclusion


This study not only provides additional insight into a possible causal association lining play mode and health outcomes of exergames, but also opens the discussion of how to optimize antidepressive effect of exergames for older adults.",2020,"Results


Findings from path analysis suggested that older adults in multiple-player exergames experienced lower levels of loneliness, and further more reduction on subthreshold depression, when compared to those in single-player exergames.","['older adults', 'Fifty-two Singaporean older adults with subthreshold depression', 'Subthreshold Depression Older Adults']",['single-player or multiple-player Nintendo Wii Tennis exergames'],"['subthreshold depression', 'social support, loneliness, and depression']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}]",52.0,0.0300616,"Results


Findings from path analysis suggested that older adults in multiple-player exergames experienced lower levels of loneliness, and further more reduction on subthreshold depression, when compared to those in single-player exergames.","[{'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Journalism and Communication, Jinan University, Guangzhou, China.'}, {'ForeName': 'Yin-Leng', 'Initials': 'YL', 'LastName': 'Theng', 'Affiliation': 'Wee Kim Wee School of Communication and Information, College of Humanities, Arts, and Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Schubert', 'Initials': 'S', 'LastName': 'Foo', 'Affiliation': 'Wee Kim Wee School of Communication and Information, College of Humanities, Arts, and Social Sciences, Nanyang Technological University, Singapore, Singapore.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.552416']
1794,33192816,Short-Term Meditation Training Fosters Mindfulness and Emotion Regulation: A Pilot Study.,"The practice of meditation has been historically linked to beneficial effects, not only in terms of spirituality but also in terms of well-being, general improvement of psychophysiological conditions and quality of life. The present study aims to assess the beneficial effects of a short-term intervention (a combination of 12 practical 1-h sessions of meditation, called  Integral Meditation , and lectures on neuroscience of meditation) on psychological indicators of well-being in subjects from the general population. We used a one-group pretest-posttest quasi-experimental design, in which all participants ( n  = 41, 17 men and 24 women, with a mean age of 41.1 years) underwent the same intervention. Out of these, 24 had already experienced meditation practice, but only 12 in a continuative way. Effects were assessed by the standardized Italian version of three self-report questionnaires: Core Outcome in Routine Evaluation-Outcome Measure (CORE-OM), Five-Facet Mindfulness Questionnaire (FFMQ), and Emotion Regulation Questionnaire (ERQ). The questionnaires were filled in at baseline and immediately after the last meditation session. Linear mixed effect models were used to evaluate pre-post treatment changes on each outcome. Participants showed a general, close to a statistically significant threshold, improvement in the total score of CORE-OM and its different domains. The total score of FFMQ (β = 0.154,  p  = 0.012) indicates a statistically significant increase in the level of mindfulness as well as in the domains  acting with awareness  (β = 0.212,  p  = 0.024), and  non-judging of inner experiences  (β = 0.384,  p  < 0.0001). Lastly, we observed a statistically significant improvement in the  cognitive reappraisal  ERQ domain (β = 0.541,  p  = 0.0003). Despite some limitations (i.e., small sample size, lack of a randomised control group and sole use of ""soft"" measurements, such as self-report questionnaires), this study offers promising results regarding the within-subject effectiveness of our intervention that includes a meditation practice on psychological indicators, thus providing interesting preliminary results.",2020,"Participants showed a general, close to a statistically significant threshold, improvement in the total score of CORE-OM and its different domains.","['all participants ( n  = 41, 17 men and 24 women, with a mean age of 41.1 years', 'subjects from the general population']","['Short-Term Meditation Training Fosters Mindfulness and Emotion Regulation', 'short-term intervention (a combination of 12 practical 1-h sessions of meditation, called  Integral Meditation , and lectures on neuroscience of meditation']","['total score of CORE-OM', 'total score of FFMQ', 'level of mindfulness', 'standardized Italian version of three self-report questionnaires: Core Outcome in Routine Evaluation-Outcome Measure (CORE-OM), Five-Facet Mindfulness Questionnaire (FFMQ), and Emotion Regulation Questionnaire (ERQ', 'cognitive reappraisal  ERQ domain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",17.0,0.022133,"Participants showed a general, close to a statistically significant threshold, improvement in the total score of CORE-OM and its different domains.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bubbico', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Iliakis', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Salvato', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Berzuini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Bruno', 'Affiliation': 'Istituto di Psicosintesi, Milan, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.558803']
1795,33192870,Randomized Control Study of the Implementation and Effects of a New Mental Health Promotion Program to Improve Coping Skills in 9 to 11 Year Old Children:  Passport: Skills for Life .,"Passport: Skills for Life  is a universal, primary school mental health promotion program to increase children's coping skills. A stratified randomized control study with pretest, post-test and 1-year follow-up included 1,492 3  rd  to 6  th  grade children, from higher and lower socio-economic levels, randomly assigned by school to receive the program or a control group. Implementation and effects were evaluated by questionnaires and focus groups with children, parents and teachers as well as classroom observations. Program activities were well implemented and greatly appreciated, with perceived improvements in resolving conflicts, communicating feelings and coping. Compared to the controls, participants had increased emotional awareness, sustained 1 year later; conceived of more ways to cope in fictitious situations and reported using more, and more useful strategies, sustained 1 year later. Positive Academic Behaviors increased, but were not sustained the following year. This is a promising program to improve coping and emotional awareness that merits further research on its effects.",2020,"Compared to the controls, participants had increased emotional awareness, sustained 1 year later; conceived of more ways to cope in fictitious situations and reported using more, and more useful strategies, sustained 1 year later.","['1,492 3  rd  to 6  th  grade children, from higher and lower socio-economic levels, randomly assigned by school to receive the program or a control group', 'Passport', '9 to 11 Year Old Children']",['New Mental Health Promotion Program'],"['Positive Academic Behaviors', 'emotional awareness', 'Coping Skills']","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]",,0.0267226,"Compared to the controls, participants had increased emotional awareness, sustained 1 year later; conceived of more ways to cope in fictitious situations and reported using more, and more useful strategies, sustained 1 year later.","[{'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Mishara', 'Affiliation': 'Psychology Department, Université du Québec à Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dufour', 'Affiliation': 'School of Psychoeducation, Université de Montréal, Montreal, QC, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.573342']
1796,33192886,Optimizing Sleep in Older Adults: Where Does High-Intensity Interval Training Fit?,"The present community-based study evaluated the effect of three different exercise interventions on sleep quality. Older adults were enrolled in one of three exercise intervention groups: high-intensity interval training (HIIT;  n  = 20), moderate-intensity continuous training (MICT;  n  = 19) or stretching (STRETCH;  n  = 22). Prior to and following the intervention, sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI was used to classify participants as poor (global PSQI score ≥5) or good (global PSQI score >5) sleepers and the effect of the intervention was examined on poor sleepers only. Around 70% of our sample was classified as poor sleepers. Poor sleepers were significantly impaired across all PSQI components, except for the use of sleeping medication, such that neither group was heavily prescribed. Exercise improved sleep quality for poor sleepers, but the intensity mattered. Specifically, MICT and STRETCH improved sleep efficiency for poor sleepers, whereas HIIT did not ( p  < 0.05). The results suggest that both MICT and STRETCH may be more effective than HIIT for optimizing sleep in poor sleepers. These findings help to inform exercise guidelines for enhancing sleep in the aging population.",2020,"Specifically, MICT and STRETCH improved sleep efficiency for poor sleepers, whereas HIIT did not ( p  < 0.05).","['Older adults', 'Older Adults']","['exercise interventions', 'MICT', 'exercise intervention groups: high-intensity interval training (HIIT;  n  = 20), moderate-intensity continuous training (MICT;  n  = 19) or stretching']","['sleep efficiency', 'Pittsburgh Sleep Quality Index (PSQI', 'sleep quality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0129187,"Specifically, MICT and STRETCH improved sleep efficiency for poor sleepers, whereas HIIT did not ( p  < 0.05).","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Kovacevic', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Kuhn', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Heisz', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.576316']
1797,33192893,"Credible Threat: Perceptions of Pandemic Coronavirus, Climate Change and the Morality and Management of Global Risks.","Prior research suggests that the pandemic coronavirus pushes all the ""hot spots"" for risk perceptions, yet both governments and populations have varied in their responses. As the economic impacts of the pandemic have become salient, governments have begun to slash their budgets for mitigating other global risks, including climate change, likely imposing increased future costs from those risks. Risk analysts have long argued that global environmental and health risks are inseparable at some level, and must ultimately be managed systemically, to effectively increase safety and welfare. In contrast, it has been suggested that we have worry budgets, in which one risk crowds out another. ""In the wild,"" our problem-solving strategies are often lexicographic; we seek and assess potential solutions one at a time, even one attribute at a time, rather than conducting integrated risk assessments. In a U.S. national survey experiment in which participants were randomly assigned to coronavirus or climate change surveys ( N  = 3203) we assess risk perceptions, and whether risk perception ""hot spots"" are driving policy preferences, within and across these global risks. Striking parallels emerge between the two. Both risks are perceived as highly threatening, inequitably distributed, and not particularly controllable. People see themselves as somewhat informed about both risks and have moral concerns about both. In contrast, climate change is seen as better understood by science than is pandemic coronavirus. Further, individuals think they can contribute more to slowing or stopping pandemic coronavirus than climate change, and have a greater moral responsibility to do so. Survey assignment influences policy preferences, with higher support for policies to control pandemic coronavirus in pandemic coronavirus surveys, and higher support for policies to control climate change risks in climate change surveys. Across all surveys, age groups, and policies to control either climate change or pandemic coronavirus risks, support is highest for funding research on vaccines against pandemic diseases, which is the only policy that achieves majority support in both surveys. Findings bolster both the finite worry budget hypothesis and the hypothesis that supporters of policies to confront one threat are disproportionately likely also to support policies to confront the other threat.",2020,"Across all surveys, age groups, and policies to control either climate change or pandemic coronavirus risks, support is highest for funding research on vaccines against pandemic diseases, which is the only policy that achieves majority support in both surveys.",[],['coronavirus or climate change surveys'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2718051', 'cui_str': 'Climate Change'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],,0.0190824,"Across all surveys, age groups, and policies to control either climate change or pandemic coronavirus risks, support is highest for funding research on vaccines against pandemic diseases, which is the only policy that achieves majority support in both surveys.","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bostrom', 'Affiliation': 'Daniel J. Evans School of Public Policy & Governance, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Böhm', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Hayes', 'Affiliation': 'School of Marine and Environmental Affairs, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': ""O'Connor"", 'Affiliation': 'Division of Social and Economic Sciences, National Science Foundation, Arlington, VA, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.578562']
1798,33193046,Brain Age Prediction of Children Using Routine Brain MR Images via Deep Learning.,"Predicting brain age of children accurately and quantitatively can give help in brain development analysis and brain disease diagnosis. Traditional methods to estimate brain age based on 3D magnetic resonance (MR), T1 weighted imaging (T1WI), and diffusion tensor imaging (DTI) need complex preprocessing and extra scanning time, decreasing clinical practice, especially in children. This research aims at proposing an end-to-end AI system based on deep learning to predict the brain age based on routine brain MR imaging. We spent over 5 years enrolling 220 stacked 2D routine clinical brain MR T1-weighted images of healthy children aged 0 to 5 years old and randomly divided those images into training data including 176 subjects and test data including 44 subjects. Data augmentation technology, which includes scaling, image rotation, translation, and gamma correction, was employed to extend the training data. A 10-layer 3D convolutional neural network (CNN) was designed for predicting the brain age of children and it achieved reliable and accurate results on test data with a mean absolute deviation (MAE) of 67.6 days, a root mean squared error (RMSE) of 96.1 days, a mean relative error (MRE) of 8.2%, a correlation coefficient ( R ) of 0.985, and a coefficient of determination ( R   2 ) of 0.971. Specially, the performance on predicting the age of children under 2 years old with a MAE of 28.9 days, a RMSE of 37.0 days, a MRE of 7.8%, a  R  of 0.983, and a  R   2  of 0.967 is much better than that over 2 with a MAE of 110.0 days, a RMSE of 133.5 days, a MRE of 8.2%, a  R  of 0.883, and a  R   2  of 0.780.",2020,"Specially, the performance on predicting the age of children under 2 years old with a MAE of 28.9 days, a RMSE of 37.0 days, a MRE of 7.8%, a  R  of 0.983, and a  R   2  of 0.967 is much better than that over 2 with a MAE of 110.0 days, a RMSE of 133.5 days, a MRE of 8.2%, a  R  of 0.883, and a  R   2  of 0.780.","['children', 'healthy children aged 0 to 5 years old and randomly divided those images into training data including 176 subjects and test data including 44 subjects']",['10-layer 3D convolutional neural network (CNN'],"['3D magnetic resonance (MR), T1 weighted imaging (T1WI), and diffusion tensor imaging (DTI) need complex preprocessing and extra scanning time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",220.0,0.0279218,"Specially, the performance on predicting the age of children under 2 years old with a MAE of 28.9 days, a RMSE of 37.0 days, a MRE of 7.8%, a  R  of 0.983, and a  R   2  of 0.967 is much better than that over 2 with a MAE of 110.0 days, a RMSE of 133.5 days, a MRE of 8.2%, a  R  of 0.883, and a  R   2  of 0.780.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'School of Informatics, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Zhangzhi', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': ""Department of Radiology, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Shui-Hua', 'Initials': 'SH', 'LastName': 'Wang', 'Affiliation': 'School of Architecture Building and Civil Engineering, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Peet', 'Affiliation': 'Institute of Cancer & Genomic Science, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Yu-Dong', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'School of Informatics, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Institute of Cancer & Genomic Science, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, Children's Hospital of Nanjing Medical University, Nanjing, China.""}]",Frontiers in neurology,['10.3389/fneur.2020.584682']
1799,33193052,Robotic Rehabilitation and Multimodal Instrumented Assessment of Post-stroke Elbow Motor Functions-A Randomized Controlled Trial Protocol.,"Background:  The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients.  Methods:  To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment. The primary outcome measures will be a set of standard clinical scales for upper limb spasticity and motor function assessment, including the Modified Ashworth Scale and Fugl-Meyer Index, to confirm the safety and evaluate the efficacy of robotic rehabilitation in reducing elbow stiffness and improving function. Secondary outcomes will include biomechanical, muscular activity, and motor performance parameters extracted from instrumented assessments using the NEEM along with synchronous EMG recordings.  Conclusions:  This randomized controlled trial aims to validate an innovative instrumented methodology for clinical spasticity assessment and functional rehabilitation, relying on the precision and accuracy of an elbow exoskeleton combined with EMG recordings and the expertise of a physiotherapist, thus complementing and maximizing the benefits of both practices.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier NCT04484571.",2020,"The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery.",['60 sub-acute and chronic stroke patients with motor impairments '],"['4-week functional rehabilitation program', 'elbow exoskeleton combined with EMG recordings', 'NEUROExos Elbow Module', 'passive mobilization and active training of elbow flexion and extension', 'Robotic Rehabilitation']","['set of standard clinical scales for upper limb spasticity and motor function assessment, including the Modified Ashworth Scale and Fugl-Meyer Index, to confirm the safety and evaluate the efficacy of robotic rehabilitation in reducing elbow stiffness and improving function', 'biomechanical, muscular activity, and motor performance parameters extracted from instrumented assessments using the NEEM along with synchronous EMG recordings', 'hemiparesis and/or spasticity']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0239272', 'cui_str': 'Elbow stiff'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1095052', 'cui_str': 'Melia azadirachta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",,0.102503,"The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pilla', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Italy.""}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Trigili', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Italy.""}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'McKinney', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fanciullacci', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Firenze, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Malasoma', 'Affiliation': 'Rehabilitation Department, Versilia Hospital, USL Nord Ovest Toscana (AUSLTNO), Lido di Camaiore (LU), Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Posteraro', 'Affiliation': 'Rehabilitation Department, Versilia Hospital, USL Nord Ovest Toscana (AUSLTNO), Lido di Camaiore (LU), Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Crea', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Italy.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vitiello', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pontedera, Italy.""}]",Frontiers in neurology,['10.3389/fneur.2020.587293']
1800,33193094,Early Intervention in Psychosis: Effectiveness and Implementation of a Combined Exercise and Health Behavior Intervention Within Routine Care.,"Aim


Young people with psychosis have higher rates of obesity, premature cardiovascular disease, and death compared to non-psychotic peers in the general population due to changes in metabolic regulation linked to antipsychotic medication and adverse health risk behaviors. The aim of this paper is to outline the development, implementation, and evaluation of a combined 12-week exercise and health behavior intervention delivered as part of an Early Intervention in Psychosis (EIP) routine service, within the UK.
Methods


Participants (n = 27) completed a 12-week combined intervention program, engaging in weekly, 90-min sessions comprising a healthy behavior education session (45 min), followed by a facilitated exercise session (45 min). Anthropometric data from participants (n = 26) were collected at baseline, 12 weeks, and 12 months post-intervention. Health behaviors and clinical measurements were assessed at baseline and 12 months.
Results


Mean baseline data suggests participants were at an increased health risk on entry to the program, with elevated values in mean body mass index (BMI; 70% overweight/obese), waist circumference, resting heart rate, and triglycerides. Fifty percent reported smoking daily, 64% ate < 5 fruits/vegetables per day, and 52% of participants were prescribed highly obesogenic antipsychotic medications (i.e., Olanzapine). At 12 weeks and 12 months, no changes were observed in mean BMI, waist circumference or any other clinical variable (p > 0.05). At 12 months, participants reported a positive impact on health behaviors including improved diet, increased physical activity levels, and cessation of substance use (n = 2), alcohol use (n = 2), and smoking (n = 4). Focus groups captured participant experiences, engagement with and satisfaction with the program, including challenges/barriers to program adherence.
Conclusions


The 12-week exercise and health behaviors program supported participants to attenuate their physical health risk which was sustained at 12-month follow-up. Self-reported positive health behavior changes are likely to have contributed to the prevention of excessive weight gain in this high-risk period. The evaluation was designed to have validity for a ""real world EIP setting"" and reflect the complexity of delivery to this participant group. Evaluation findings influenced subsequent commissioning of the physical health intervention as an ongoing element of routine EIP care within the participant site.",2020,"At 12 weeks and 12 months, no changes were observed in mean BMI, waist circumference or any other clinical variable (p > 0.05).","['Young people with psychosis', 'Psychosis', 'Methods\n\n\nParticipants (n = 27) completed a 12-week']","['combined intervention program, engaging in weekly, 90-min sessions comprising a healthy behavior education session (45\xa0min), followed by a facilitated exercise session', 'exercise and health behaviors program', 'Olanzapine', 'Combined Exercise and Health Behavior Intervention']","['mean BMI, waist circumference', 'health behaviors including improved diet, increased physical activity levels, and cessation of substance use (n = 2), alcohol use', 'Health behaviors and clinical measurements', 'highly obesogenic antipsychotic medications', 'waist circumference, resting heart rate, and triglycerides']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0851792', 'cui_str': 'Increased physical activity levels'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",26.0,0.0302223,"At 12 weeks and 12 months, no changes were observed in mean BMI, waist circumference or any other clinical variable (p > 0.05).","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Griffiths', 'Affiliation': 'Department of Nutrition, Food and Exercise Science, Florida State University, Tallahassee, FL, United States.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Band', 'Affiliation': 'Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hird-Smith', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Bold', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Bradley', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dilworth', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Horne', 'Affiliation': 'School of Allied Health and Community, University of Worcester, Worcester, United Kingdom.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.577691']
1801,33193668,Construction of a Nomogram Based on a Hypoxia-Related lncRNA Signature to Improve the Prediction of Gastric Cancer Prognosis.,"Background


Gastric cancer is one of the most common malignant tumors and has a poor prognosis. Hypoxia is related to the poor prognosis of cancer patients. We searched for hypoxia-related long non-coding RNAs (lncRNAs) to predict both overall survival (OS) and disease-free survival (DFS) of gastric cancer patients.
Methods


We obtained hypoxia-related lncRNA expression profiles and clinical follow-up data of patients with gastric cancer from The Cancer Genome Atlas and the Molecular Signatures Database. The patients were randomly divided into a training group, test group and combined group. The hypoxia-related prognostic signature was constructed by Lasso regression and Cox regression models, the prognoses in different groups were compared by Kaplan-Meier (K-M) analysis, and the accuracy of the prognostic model was assessed by receiver operating characteristic (ROC) analysis.
Results


A hypoxia-related prognostic signature comprising 10 lncRNAs was constructed to predict both OS and DFS in gastric cancer. In the training, test and combined groups, patients were divided into high- and low-risk groups according to the formula. Kaplan-Meier analysis showed that patients in the high-risk group have poor prognoses, and the difference was significant in the subgroup analyses. Receiver operating characteristic analysis revealed that the predictive power of the model prediction is more accurate than that of standard benchmarks. The signature differed across  Helicobacter pylori  (Hp) status and T stages. Multivariate Cox analysis showed that the signature is an independent risk factor for both OS and DFS. A clinically predictive nomogram combining the lncRNA signature and clinical features was constructed; the nomogram accurately predicted both OS and DFS and had high clinical application value. Weighted correlation network analysis combined with enrichment analysis showed that the primary pathways were the PI3K-Akt, JAK-STAT, and IL-17 signaling pathways. The target genes NOX4, COL8A1, and CHST1 were associated with poor prognosis in the Gene Expression Profiling Interactive Analysis, Gene Expression Omnibus, and K-M Plotter databases.
Conclusions


Our 10-lncRNA prognostic signature and nomogram are accurate, reliable tools for predicting both OS and DFS in gastric cancer.",2020,"The target genes NOX4, COL8A1, and CHST1 were associated with poor prognosis in the Gene Expression Profiling Interactive Analysis, Gene Expression Omnibus, and K-M Plotter databases.
","['cancer patients', 'gastric cancer patients', 'patients with gastric cancer from The Cancer Genome Atlas and the Molecular Signatures Database']",[],"['overall survival (OS) and disease-free survival (DFS', 'Helicobacter pylori  (Hp) status and T stages']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}]",10.0,0.0291099,"The target genes NOX4, COL8A1, and CHST1 were associated with poor prognosis in the Gene Expression Profiling Interactive Analysis, Gene Expression Omnibus, and K-M Plotter databases.
","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Research, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Lang', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Research, Guangxi Medical University Cancer Hospital, Nanning, China.'}, {'ForeName': 'Kaihua', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, China.'}]",Frontiers in genetics,['10.3389/fgene.2020.570325']
1802,33193768,The Effect of Brief Crisis Intervention Package on Improving Quality of Life and Mental Health in Patients with COVID-19.,"Objective:  COVID 19 is having a devastating effect on mankind's life. Individuals with COVID-19 will experience high levels of stress, depression, anxiety, and low quality of life. The goals the of present study were to investigate the effect of brief crisis intervention package on stress, depression, anxiety, and quality of life in patient with COVID-19.  Method   :  In this randomized controlled clinical trial, 30 patients were randomly selected and divided into control and experimental groups. The experimental group was examined in four 60-minute sessions for one month. During this period, the control group received only routine treatment and therapy. Before and after the intervention, DASS21, the Symptom Checklist (SCL-25), and WHO-QOL were used to measure and record patient mental health and quality of life. Finally, data were analyzed using SPSS 24 software.  Results:  The average mental health score was assessed with WHO-QOL, DASS21, and SCL-25 before intervention and was not statistically significant (P = > 0.05), and the mean score of stress, anxiety, depression, WHO-QOL, SCL-25 after intervention was statistically significant (P < 0.001). Therefore, results showed the brief crisis intervention package was effective in improving the quality of life (P < 0.05) and mental illnesses (P < 0.05) in patients with COVID-19.  Conclusion:  The brief crisis intervention package can reduce the negative effect of patients with COVID-19. Therefore, this intervention can be used as a beneficial treatment to improve mental disorder symptoms and to improve the condition of people who suffer from COVID-19.",2020,"Therefore, results showed the brief crisis intervention package was effective in improving the quality of life (P < 0.05) and mental illnesses (P < 0.05) in patients with COVID-19.  ","['patients with COVID-19', 'patient with COVID-19', '30 patients', 'Patients with COVID-19']","['crisis intervention package', 'Brief Crisis Intervention Package']","['mental illnesses', 'average mental health score', 'mean score of stress, anxiety, depression, WHO-QOL, SCL-25', 'Quality of Life and Mental Health', 'stress, depression, anxiety, and quality of life', 'DASS21, the Symptom Checklist (SCL-25), and WHO-QOL were used to measure and record patient mental health and quality of life', 'quality of life', 'mental disorder symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0010332', 'cui_str': 'Crisis intervention'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.0243308,"Therefore, results showed the brief crisis intervention package was effective in improving the quality of life (P < 0.05) and mental illnesses (P < 0.05) in patients with COVID-19.  ","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Gharaati Sotoudeh', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Salman', 'Initials': 'SS', 'LastName': 'Alavi', 'Affiliation': 'Psychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zari', 'Initials': 'Z', 'LastName': 'Akbari', 'Affiliation': 'Psychology Department, Roudehen Branch, Islamic Azad University, Roudehen, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Jannatifard', 'Affiliation': 'Ministry of Education, Tehran, Iran.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Artounian', 'Affiliation': 'Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of psychiatry,['10.18502/ijps.v15i3.3812']
1803,33193782,The Effect of the combination of active vestibular interventions and occupational therapy on Balance in Children with Bilateral Spastic Cerebral Palsy: A pilot randomized Controlled trial.,"Objective


The current study aimed to examine the effect of the combined administration of active vestibular interventions and occupational therapy on balance and the relationship between balance changes and Activity of Daily Living in school-aged children with cerebral palsy (CP).
Materials & Methods


Twenty-four children with Spastic CP, at the level I and II (according to the ""Gross Motor Function Classification System) aged 7-12 years were enrolled and randomly assigned into control and intervention groups. Pediatric Balance Scales and Bruininks-Oseretsky Test of Motor Proficiency II were employed to assess the functional balance changes as well as Force Plate (eyes closed and open) to assess changes in the parameters of balance (e.g. center of pressure excursion). The activity of Daily Living was assessed by ""Activity Scales for Kids (performance version)"". Participants in the intervention group received active vestibular intervention for 20 min and a regular occupational therapy program for 25 min. The control group received a regular occupational therapy program for 45 min. Interventions were provided 3 d/week for 6 weeks in each group. The participants were assessed in three stages: baseline, immediately after, and eight weeks after the intervention. Data were analyzed by ANOVA and linear regression.
Results


The results demonstrated that only functional balance, according to Pediatric Balance Scales scores, was significantly increased in the active vestibular interventions group (p=0.02). There was no significant association between functional balance and Activity of Daily Living (P>0.05).
Conclusion


The combined administration of active vestibular interventions and occupational therapy could improve the functional balance in children with spastic CP. It may be related to the reorganization of the vestibular system with a controlled and precise application of stimuli.",2020,"The results demonstrated that only functional balance, according to Pediatric Balance Scales scores, was significantly increased in the active vestibular interventions group (p=0.02).","['Children with Bilateral Spastic Cerebral Palsy', 'children with spastic CP', 'school-aged children with cerebral palsy (CP', 'Materials & Methods\n\n\nTwenty-four children with Spastic CP, at the level I and II (according to the ""Gross Motor Function Classification System) aged 7-12 years']","['regular occupational therapy program', 'active vestibular intervention for 20 min and a regular occupational therapy program', 'active vestibular interventions and occupational therapy']","['functional balance', 'functional balance and Activity of Daily Living (P>0.05', 'Activity Scales for Kids (performance version', 'activity of Daily Living', 'Pediatric Balance Scales scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0313004,"The results demonstrated that only functional balance, according to Pediatric Balance Scales scores, was significantly increased in the active vestibular interventions group (p=0.02).","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rassafiani', 'Affiliation': 'Occupational Therapy Department, Faculty of Allied Health Sciences, Kuwait University, Kuwait. Pediatric Neurorehabilitation Research Center, Tehran, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Akbarfaimi', 'Affiliation': 'Department of Occupational\xa0Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ali', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Occupational\xa0Therapy, Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Shahshahani', 'Affiliation': 'Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Karimlou', 'Affiliation': 'Biostatist (ics), Social Determinants of Health Research Center University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Tabatabai Ghomsheh', 'Affiliation': 'Associate Professor, Department of Ergonomics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Iranian journal of child neurology,[]
1804,33193783,Evaluation of the Efficacy of LevetiracetamPlus Iron in Comparison With Iron Alone in Controlling and Reducing the Frequency of Breath-Holding Spells in Children Aged 6 Months to 5 Years.,"Objective


A breath-holdingspell (BHS) is defined as an apnea attack following an initial stressful event like anger, sadness, and fear, a painful event like falling or head trauma or any stressful psychology event. This study was designed to assessthe comparative efficacy of levetiracetam plus iron and iron alone in reducingthe BHS frequency in children aged 6 months to 5 years.
Materials &Method


This study was designed asa double-blinded randomized clinical trial. Sixty patients aged 6 months to 5 years were assigned into two groups, withthe first group (A) receiving onlyiron and the second group (B)receiving levetiracetam plus iron. At the end of the study, the efficacy of therapywas analyzed comparatively in these groups.
Results


In this study, the mean number of attacks was 3.94 ± 2.69 before treatment and 1.71 ± 1.99after treatmentin the group A,while it was 6.39 ± 5.7 before treatment and 0.37 ± 1.03after treatment in the group B.The mean number of attacksafter treatment was lower in group B than in group A. In fact, there was a significant difference between the two groups in terms of the number of attacks after treatment (P = 0.003).
Conclusion


Levetiracetam plus iron is more effective than iron alone in reducing BHSs in children aged 6 months to 5 years.",2020,"Conclusion


Levetiracetam plus iron is more effective than iron alone in reducing BHSs in children aged 6 months to 5 years.","['Children Aged 6 Months to 5 Years', 'Sixty patients aged 6 months to 5 years', 'children aged 6 months to 5 years']","['levetiracetam plus iron and iron alone', 'breath-holdingspell (BHS', 'onlyiron and the second group (B)receiving levetiracetam plus iron']","['mean number of attacks', 'BHSs', 'mean number of attacksafter treatment', 'Frequency of Breath-Holding Spells', 'number of attacks']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0476287', 'cui_str': 'Breath holding spell'}]",60.0,0.0866329,"Conclusion


Levetiracetam plus iron is more effective than iron alone in reducing BHSs in children aged 6 months to 5 years.","[{'ForeName': 'Ezatolah', 'Initials': 'E', 'LastName': 'Abbasi', 'Affiliation': 'Pediatric Neurology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Ghazavi', 'Affiliation': 'Pediatric Neurology, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Hassanvand Amouzadeh', 'Affiliation': 'Neuroscience Research Center, Qom University of Medical Sciences,Qom,Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Valizadeh', 'Affiliation': 'Pediatrician, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Matinkhah', 'Affiliation': 'Pediatrician, Urmia University of Medical Sciences, Urmia, Iran.'}]",Iranian journal of child neurology,[]
1805,33193786,Efficacy of Topiramate Alone and Topiramate Plus Vitamin D3 in the Prophylaxis of Pediatric Migraine: A Randomized Clinical Trial.,"Objective


Topiramate is effective in the prevention of pediatric migraine, and studies show that vitamin D 3  supplementation might also be useful in the treatment of adult migraineurs with a normal vitamin D 3  level. The present study aimed at comparing the efficacy and safety of topiramate plus vitamin D 3  and topiramate alone in the prophylaxis of pediatric migraine.
Materials & Methods


In a single-blinded, randomized, clinical trial, 5-15-year-old children with migraine headaches, referred to the Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January 2016 to January 2017, were randomly allocated to receive 2 mg/kg/day of topiramate or 2 mg/kg/day of topiramate plus one 500,000 IU vitamin D 3  pearl weekly for two consecutive months.Primary outcomes were the reduction of monthly frequency, severity, duration, and the disability score of migraine, and the secondary outcomes included a good response to treatment (more than 50% reduction in monthly headache frequency) and a lack of clinical adverse events.
Results


Totally, 31 female and 26 male children with the mean age of 10.02±2.11 years were evaluated. Both drugs were effective in the reduction of monthly frequency, severity, duration, and disability for headaches. Nevertheless, the combination of topiramate and vitamin D 3  was more effective than topiramate alone in reducing the monthly headaches frequency (6.12±1.26 vs. 9.87±2.44 times, P=0.01) and disability score (19.24±6.32 vs. 22.11±7.91, P=0.02). Good response to treatment was observed in 60.7% and 75.9% of the subjects in the topiramate alone and topiramate plus vitamin D 3  groups, respectively, and topiramate plus vitaminD3 was more effective (P= 0.01). Transient mild side effects were observed in 14.3% and 17.2% of the subjects in the topiramate alone and topiramate plus vitamin D 3  groups, respectively (P=0.8).
Conclusion


A combination of topiramate and vitamin D 3  might be considered safe and more effective than topiramate alone in the prophylaxis of pediatric migraine.",2020,"Both drugs were effective in the reduction of monthly frequency, severity, duration, and disability for headaches.","['adult migraineurs with a normal vitamin D 3  level', '5-15-year-old children with migraine headaches,\xa0referred to the Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from January 2016 to January 2017', 'Pediatric Migraine', '31 female and 26 male children with the mean age of 10.02±2.11 years were evaluated']","['Topiramate', 'topiramate', 'topiramate or 2 mg/kg/day of topiramate plus one 500,000 IU vitamin D', 'topiramate plus vitamin D 3  and topiramate alone', 'topiramate and vitamin D', 'Topiramate Alone and Topiramate Plus Vitamin D3']","['monthly headaches frequency', 'Transient mild side effects', 'efficacy and safety', 'reduction of monthly frequency, severity, duration, and the disability score of migraine', 'monthly headache frequency) and a lack of clinical adverse events', 'monthly frequency, severity, duration, and disability for headaches', 'disability score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3715202', 'cui_str': 'Child and adolescent neurology clinic'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0544678,"Both drugs were effective in the reduction of monthly frequency, severity, duration, and disability for headaches.","[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Fallah', 'Affiliation': 'Department of Pediatrics, Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Saeedreza', 'Initials': 'S', 'LastName': 'Sarraf Yazd', 'Affiliation': 'Department of Clinical Pharmacology, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seid Mojtaba', 'Initials': 'SM', 'LastName': 'Sohrevardi', 'Affiliation': 'Department of Clinical Pharmacology, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Iranian journal of child neurology,[]
1806,33193830,Hypothesis generative head-to-head study comparing efficacy of afatinib and osimertinib based on immunological biomarkers in Japanese NSCLC patients with EGFR mutations (Heat on Beat study).,"Background


In the FLAURA trial, superiority of osimertinib over the standard of care (SOC) was not demonstrated in Asian patients; SOC seemed favorable among Japanese patients (hazard ratio 1.39, 95% confidence interval 0.82-2.33). Three reasons are suggested: since rechallenge with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is covered by health insurance in Japan, EGFR-TKI rechallenge rate was higher in SOC than in the osimertinib group, which resulted in a long-term sequential administration of EGFR-TKIs; treatment discontinuation rate was high in the osimertinib group due to adverse events such as interstitial pneumonia among Japanese patients. EGFR-TKIs enhance tumor antigen-specific cytotoxicity of T cells, especially first- and second-generation EGFR-TKIs, which are more active against various cells with wild-type EGFR, including regulatory T cells. Consequently, subsequent immune checkpoint inhibitor therapy seemed more promising in the SOC group. Therefore, optimal first-line EGFR-TKI for EGFR-mutant advanced lung cancer may not have been identified in Japanese patients.
Methods


The Heat on Beat study is a randomized, open-label, multicenter, phase II study to compare OS between initial treatment with afatinib and osimertinib in treatment-naïve patients with advanced or recurrent EGFR-mutant NSCLC. Exploration of immunomonitoring through peripheral blood mononuclear cells will also be performed, before, during, and after treatment. Treatment-naïve EGFR mutation-positive non-small cell lung cancer (NSCLC) patients ( N  = 100) will be randomized to two groups in a 1:1 ratio. The co-primary endpoints are 3-year survival rate and characterization of immune environment associated with response to afatinib, osimertinib, or immune checkpoint inhibitors. Enrollment will start in May 2020 at 28 sites in Japan and continue for 1 year, with 3-year follow-up.
Discussion


Because there is no clinical trial comparing second- with third-generation EGFR-TKI for advanced EGFR-mutant NSCLC, our study would provide a major impact on clinical practice.  Trial registration  Japan Registry of Clinical Trials, jRCTs031190221, registered date: 25 February 2020, https://jrct.niph.go.jp/en-latest-detail/jRCTs031190221.",2020,", superiority of osimertinib over the standard of care (SOC) was not demonstrated in Asian patients; SOC seemed favorable among Japanese patients (hazard ratio 1.39, 95% confidence interval 0.82-2.33).","['advanced EGFR-mutant NSCLC', 'Treatment-naïve EGFR mutation-positive non-small cell lung cancer (NSCLC) patients ( N \u2009=\u2009100', 'Japanese NSCLC patients with EGFR mutations (Heat on Beat study', 'treatment-naïve patients with advanced or recurrent EGFR-mutant NSCLC', 'Japanese patients']",['afatinib and osimertinib'],"['EGFR-TKIs enhance tumor antigen-specific cytotoxicity of T cells', '3-year survival rate and characterization of immune environment associated with response to afatinib, osimertinib, or immune checkpoint inhibitors']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0041361', 'cui_str': 'Tumor-associated antigen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",,0.0695175,", superiority of osimertinib over the standard of care (SOC) was not demonstrated in Asian patients; SOC seemed favorable among Japanese patients (hazard ratio 1.39, 95% confidence interval 0.82-2.33).","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Morikawa', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Aomori, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Itani', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Ise Hospital, Mie, Japan.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Takata', 'Affiliation': 'Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Soejima', 'Affiliation': 'Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Kaira', 'Affiliation': 'Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kagamu', 'Affiliation': 'Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Matsutani', 'Affiliation': 'Department of Surgery, Teikyo University Hospital, Mizonokuchi, Kanagawa, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo 173-8606, Japan.'}]",Therapeutic advances in medical oncology,['10.1177/1758835920967254']
1807,33193835,Efficacy and safety of interferon on neonates with respiratory syncytial virus pneumonia.,"Respiratory syncytial virus (RSV) pneumonia is a leading cause of hospitalization and mortality among neonates worldwide, and there are currently no specific clinical treatments for RSV infection. Interferons (IFNs) possess broad-spectrum antiviral properties, and the present study aimed to evaluate the efficacy and safety of IFN-α1b for the treatment of neonatal RSV pneumonia. Neonates with RSV pneumonia were divided into the treatment (126 neonates) and control (160 neonates) groups, the former of which were treated with IFN. Aside from IFN administration, both groups received the same routine treatments. There were no significant differences in patient characteristics between the two groups. All neonates in the two groups displayed symptoms such as a cough (93.0%), tachypnea (90.1%), perilabial cyanosis (67.8%), choking on milk (62.9%) and moist rales (58.4%), and no significant differences in the occurrence of these symptoms were observed between the groups (P>0.05). The percentage of cases with bacterial co-infection was 66.8% (191/286), and the bacterial species in the spectrum primarily included  Escherichia coli  (21.5%),  Klebsiella pneumonia  (20.4%),  Staphylococcus aureus  (17.2%),  Acihetobacter baumanii  (13.1%) and  Pseudomonas aeruginosa  (9.9%). There were no significant differences in the co-infection rate or bacterial spectrum between the two groups. The remission time of cough, tachypnea, choking on milk, perilabial cyanosis, moist rales and oxygen inhalation in the treatment group was significantly lower compared with the control group (P<0.05). Although the hospitalization time in the treatment group was shorter compared with the control group, the difference was not significant. There were two patients in the treatment group that developed fever within 2-6 h after receiving IFN-α1b, though no other adverse effects were observed. In conclusion, IFN-α1b treatment improved the symptoms associated with neonatal RSV pneumonia with minimal adverse effects.",2020,"There were two patients in the treatment group that developed fever within 2-6 h after receiving IFN-α1b, though no other adverse effects were observed.","['neonatal RSV pneumonia', 'Neonates with RSV pneumonia', 'neonates with respiratory syncytial virus pneumonia']","['interferon', 'IFN', 'Interferons (IFNs', 'IFN-α1b']","['tachypnea', 'moist rales', 'perilabial cyanosis', 'adverse effects', 'Klebsiella pneumonia', 'Efficacy and safety', 'remission time of cough, tachypnea, choking on milk, perilabial cyanosis, moist rales and oxygen inhalation', 'fever', 'hospitalization time', 'co-infection rate or bacterial spectrum', 'choking on milk', 'percentage of cases with bacterial co-infection']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0152413', 'cui_str': 'Pneumonia due to respiratory syncytial virus'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0858640', 'cui_str': 'Moist rales'}, {'cui': 'C0010520', 'cui_str': 'Cyanosis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0519030', 'cui_str': 'Pneumonia due to Klebsiella pneumoniae'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",,0.0287544,"There were two patients in the treatment group that developed fever within 2-6 h after receiving IFN-α1b, though no other adverse effects were observed.","[{'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Scientific Research and Education Section, Chongqing Health Center for Women and Children, Chongqing 401120, P.R. China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Breast and Thyriod Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, P.R. China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Scientific Research and Education Section, Chongqing Health Center for Women and Children, Chongqing 401120, P.R. China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Scientific Research and Education Section, Chongqing Health Center for Women and Children, Chongqing 401120, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9350']
1808,33194060,Reduction of depression symptoms in laryngeal cancer patients receiving psychology services.,"Depression is prevalence in patients with laryngeal cancer. In this study, we aim to investigate whether psychological intervention could reduce the depression of patients receiving cancer treatment. In this study, 258 patients with laryngeal cancer were assigned into two groups with or without psychological intervention. The depression symptoms of all patients were assessed using Hamilton depression rating scale (HAMD) and Hamilton anxiety rating scale (HAMA). Europe Organization for research and Treatment of cancer Quality of life Questionnaire (EORTC QLQ-C30) was used to measure the life quality of the participants. Other measurements including general attitudes towards psychology services, hospitalization duration and expenses were analyzed. We found that patients with intervention showed more positive attitudes towards psychology services compared to those in control group. Hospitalization duration and expenses were significantly less in intervention group compared to control group. In addition, the intervention group showed a significantly lower HAMD and HAMA scores and improved life quality than control group. Patients aged lower than 40 years showed more obvious reductions in HAMD and HAMA scores and better life quality compared to older patients. In conclusion, our study demonstrated that psychological intervention was necessary and effective in patients with laryngeal cancer during treatment.",2020,Patients aged lower than 40 years showed more obvious reductions in HAMD and HAMA scores and better life quality compared to older patients.,"['patients with laryngeal cancer during treatment', '258 patients with laryngeal cancer', 'patients receiving cancer treatment', 'patients with laryngeal cancer', 'Patients aged lower than 40 years', 'laryngeal cancer patients receiving psychology services']",['psychological intervention'],"['Hospitalization duration and expenses', 'depression symptoms', 'positive attitudes towards psychology services', 'Hamilton depression rating scale (HAMD) and Hamilton anxiety rating scale (HAMA', 'general attitudes towards psychology services, hospitalization duration and expenses', 'cancer Quality of life Questionnaire (EORTC QLQ-C30', 'HAMD and HAMA scores and better life quality', 'HAMD and HAMA scores and improved life quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007107', 'cui_str': 'Malignant tumor of larynx'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0587654', 'cui_str': 'Psychology service'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0587654', 'cui_str': 'Psychology service'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",258.0,0.0208265,Patients aged lower than 40 years showed more obvious reductions in HAMD and HAMA scores and better life quality compared to older patients.,"[{'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology, Weifang People's Hospital No. 151 Guangwen Street, Kuiwen District, Weifang 261041, Shandong, China.""}, {'ForeName': 'Haina', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Otorhinolaryngology, Weifang People's Hospital No. 151 Guangwen Street, Kuiwen District, Weifang 261041, Shandong, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology, Weifang People's Hospital No. 151 Guangwen Street, Kuiwen District, Weifang 261041, Shandong, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Otorhinolaryngology, Weifang People's Hospital No. 151 Guangwen Street, Kuiwen District, Weifang 261041, Shandong, China.""}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, Weifang People's Hospital No. 151 Guangwen Street, Kuiwen District, Weifang 261041, Shandong, China.""}]",American journal of translational research,[]
1809,33194102,Administration of Tranexamic Acid in Proximal Humeral Fractures.,"Introduction


This study aimed to analyze the efficacy of intravenous administration of tranexamic acid in complex proximal humeral fractures.
Materials and methods


Sixty-seven patients with displaced 3 and 4 part proximal humerus fractures were randomized into the control ( n  = 33) and TXA ( n  = 34) groups. Fifteen minutes before the skin incision, 15 mg/kg body weight of 0.9% sodium chloride solution or TXA was injected intravenously. Open reduction and internal fixation was conducted through a deltoid-pectoral approach with fixed angle locked plating (PHILOS) for all the patients. The patients were followed up 2 months after surgery. Total blood loss, blood test results, blood transfusion rate, and wound complications were analyzed between the two groups.
Results


Significant differences were observed in intraoperative blood loss and postoperative blood loss during the first 24 h between the two groups. There were no significant differences in postoperative blood loss during the second 24 h, wound complication rates, blood transfusion rate and adverse side effects. And thromboembolic events related with the application of TXA were not noted in the TXA group.
Conclusion


Preoperative administration of tranexamic acid could reduce intraoperative and postoperative blood loss in patients with complex proximal humeral fractures.
Level of evidence


II, prospective comparative study.",2020,"There were no significant differences in postoperative blood loss during the second 24 h, wound complication rates, blood transfusion rate and adverse side effects.","['Materials and methods\n\n\nSixty-seven patients with displaced 3 and 4 part proximal humerus fractures', 'Proximal Humeral Fractures', 'patients with complex proximal humeral fractures']","['sodium chloride solution or TXA', 'Tranexamic Acid', 'tranexamic acid', 'deltoid-pectoral approach with fixed angle locked plating (PHILOS', 'TXA']","['postoperative blood loss', 'wound complication rates, blood transfusion rate and adverse side effects', 'intraoperative and postoperative blood loss', 'Total blood loss, blood test results, blood transfusion rate, and wound complications', 'intraoperative blood loss and postoperative blood loss']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}]","[{'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",67.0,0.0260246,"There were no significant differences in postoperative blood loss during the second 24 h, wound complication rates, blood transfusion rate and adverse side effects.","[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Wannan Medical College, No. 2 Zheshan West Road, Jinghu District, Wuhu, 241000 Anhui People's Republic of China.""}, {'ForeName': 'Hongjiu', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Wannan Medical College, No. 2 Zheshan West Road, Jinghu District, Wuhu, 241000 Anhui People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Wannan Medical College, No. 2 Zheshan West Road, Jinghu District, Wuhu, 241000 Anhui People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Wannan Medical College, No. 2 Zheshan West Road, Jinghu District, Wuhu, 241000 Anhui People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Wannan Medical College, No. 2 Zheshan West Road, Jinghu District, Wuhu, 241000 Anhui People's Republic of China.""}]",Indian journal of orthopaedics,['10.1007/s43465-020-00128-0']
1810,33194143,Turning unprofessional behaviors around using Holmes' reflection approach: a randomized controlled study.,"Many medical schools around the world have included professionalism training in their formal curriculum. However, these efforts may not be adequate; given the exposure of students to unprofessional behaviors in the clinical settings. In the present study, we aimed to design, implement, and evaluate a longitudinal program to improve professionalism among medical students upon their transition to clinical settings. A total of 75 medical students were enrolled in the study and randomly assigned to two groups. The control group did not receive any training, while for the intervention group; a 10-hour program through 16 weeks was organized based on the Holmes' reflection approach. The effectiveness of the program was evaluated by measuring three outcomes in both groups. Data analysis was performed using paired t-test and Multiple Linear Regression. Scores of judgment of professionalism increased in the intervention group (from 7.56 to 10.17;  P < 0.001), while there was no significant improvement in the control group's scores. Students' attitudes towards professionalism and their professional behaviors did not change significantly. Based on our findings, the Holmes reflection approach helps students improve their cognitive base of professionalism. Long-term follow-up and further qualitative studies will help us better understand the effects of this approach on other desirable outcomes.",2020,"Scores of judgment of professionalism increased in the intervention group (from 7.56 to 10.17;  P < 0.001), while there was no significant improvement in the control group's scores.","['A total of 75 medical students', 'medical students upon their transition to clinical settings']",[],"['Scores of judgment of professionalism', ""Students' attitudes towards professionalism and their professional behaviors""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0815219', 'cui_str': 'Professionalism'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",75.0,0.0245687,"Scores of judgment of professionalism increased in the intervention group (from 7.56 to 10.17;  P < 0.001), while there was no significant improvement in the control group's scores.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Naeimi', 'Affiliation': 'Researcher, Department of Medical Education, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran; Medical Education Development Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Asghari', 'Affiliation': 'Associate Professor, Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saharnaz', 'Initials': 'S', 'LastName': 'Nedjat', 'Affiliation': 'Professor, Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Mirzazadeh', 'Affiliation': 'Associate Professor, Department of Medical Education, Health Professions Education Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abbaszadeh', 'Affiliation': 'Assistant Professor, Department of Internal Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Sima', 'Affiliation': 'Assistant Professor, Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mortaz Hejri', 'Affiliation': 'Assistant Professor, Department of Medical Education, Educational Development Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of medical ethics and history of medicine,['10.18502/jmehm.v13i12.4388']
1811,33194183,Evaluation of ultrasonic axillary dissection in preservation of intercostobrachial nerve and lymphatic sealing in breast cancer patients: Randomized controlled trial.,"Background


Electrocautery has been shown to be associated with excessive serous drainage which may lead to many complications in patients with breast cancer needing dissection of the axillary lymph nodes. The Harmonic Focus could outperform electrocautery in dissection of axillary lymph nodes, resulting in shortening of the operative times and minimize postoperative complications .  This study aims to compare the mean axillary drain production and the axillary numbness frequency in axillary lymph node dissection (ANLD) during Modified Radical Mastectomy (MRM) and breast conservative surgery (BCS) between the use of harmonics scalpel and electrocautery.
Methods


This study includes 40 patients presented with early breast cancer (T1 and T2) underwent BCS or MRM in general surgery department, Faculty of Medicine, Benha University Hospital during the period from January 2017 to September 2019. The patients randomly assigned into 2 groups; group A: subjected to ANLD using Harmonic Focus tool and group B: subjected to ANLD using electrocautery. Operative time, total drainage volume, blood loss, duration of the drain and frequency of axillary numbness were recorded.
Results


This study shows that using Harmonic in axillary dissection considerably reduced operating time, total drainage volume, blood loss, days of hospital stays and reduced axillary numbness level in comparison to conventional electrocautery.
Conclusion


Compared to the normal electrocautery, the harmonic focus dissection has major advantages in lowering postoperative drainage, blood loss intra-operative and lower incidence of axillary numbness in breast cancer axillary dissection, without affecting operating time.",2020,"The Harmonic Focus could outperform electrocautery in dissection of axillary lymph nodes, resulting in shortening of the operative times and minimize postoperative complications .  ","['40 patients presented with early breast cancer (T1 and T2) underwent BCS or MRM in general surgery department, Faculty of Medicine, Benha University Hospital during the period from January 2017 to September 2019', 'breast cancer patients', 'patients with breast cancer needing dissection of the axillary lymph nodes']","['harmonics scalpel and electrocautery', 'ANLD using Harmonic Focus tool and group B: subjected to ANLD using electrocautery', 'axillary lymph node dissection (ANLD', 'Modified Radical Mastectomy (MRM) and breast conservative surgery (BCS', 'ultrasonic axillary dissection']","['Operative time, total drainage volume, blood loss, duration of the drain and frequency of axillary numbness', 'mean axillary drain production', 'operating time, total drainage volume, blood loss, days of hospital stays and reduced axillary numbness level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}]","[{'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0724229,"The Harmonic Focus could outperform electrocautery in dissection of axillary lymph nodes, resulting in shortening of the operative times and minimize postoperative complications .  ","[{'ForeName': 'Ahmed M F', 'Initials': 'AMF', 'LastName': 'Salama', 'Affiliation': 'Department of General Surgery, Benha University Hospital, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Nawar', 'Affiliation': 'Department of General Surgery, Benha University Hospital, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed E', 'Initials': 'ME', 'LastName': 'Zayed', 'Affiliation': 'Department of General Surgery, Benha University Hospital, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Essa', 'Affiliation': 'Department of General Surgery, Benha University Hospital, Faculty of Medicine, Benha University, Benha, Egypt.'}]",Annals of medicine and surgery (2012),['10.1016/j.amsu.2020.10.059']
1812,33194196,Phase I trial of nedaplatin and S-1 in patients with advanced squamous cell lung cancer.,"The platinum doublet is considered to be the standard cytotoxic chemotherapy for advanced lung cancer. It has been previously reported that nedaplatin and S-1 have clinical efficacy against squamous cell lung cancer. As the combination of nedaplatin and S-1 has never been studied for advanced squamous cell lung cancer, a phase I trial of this combination in the first-line setting was conducted. Patients who had not received chemotherapy previously, aged ≤75 years and with advanced squamous cell lung cancer were recruited. Nedaplatin was administered intravenously (day 1), and S-1 was orally administered (days 1-14) at a fixed dose based on the body surface area (BSA) <1.25 m 2 , 80 mg/day; BSA=1.25-1.5 m 2 , 100 mg/day; and BSA ≥1.5 m 2 , 120 mg/day. A total of 9 patients were enrolled. The maximum tolerated dose was 80 mg/m 2  for nedaplatin. At this dosage, dose-limiting toxicity was observed in 2 of the 6 patients. A total of one patient experienced grade 3 thrombocytopenia, and the other patient experienced grade 3 anorexia and grade 3 nausea. The recommended dose for phase II studies was determined as being 70 mg/m 2  for nedaplatin (clinical trial registration no. UMIN-CTR UMIN000036387).",2020,"At this dosage, dose-limiting toxicity was observed in 2 of the 6 patients.","['advanced squamous cell lung cancer', 'A total of 9 patients were enrolled', 'patients with advanced squamous cell lung cancer', 'Patients who had not received chemotherapy previously, aged ≤75 years and with advanced squamous cell lung cancer', 'advanced lung cancer']","['cytotoxic chemotherapy', 'Nedaplatin', 'nedaplatin and S-1']","['grade 3 thrombocytopenia', 'toxicity', 'grade 3 anorexia and grade 3 nausea']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0149782', 'cui_str': 'Squamous cell carcinoma of lung'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0093999', 'cui_str': 'nedaplatin'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",9.0,0.032708,"At this dosage, dose-limiting toxicity was observed in 2 of the 6 patients.","[{'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kanaji', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 761-0793, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 761-0793, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Ueda', 'Affiliation': 'Department of Respiratory Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa 760-8557, Japan.'}, {'ForeName': 'Hirohisa', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Internal Medicine, Federation of National Public Service Personnel Mutual Aid Associations Takamatsu Hospital, Takamatsu, Kagawa 760-0018, Japan.'}, {'ForeName': 'Nobuhito', 'Initials': 'N', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Pulmonary Medicine, Takamatsu Municipal Hospital, Takamatsu, Kagawa 761-8538, Japan.'}, {'ForeName': 'Norimitsu', 'Initials': 'N', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa 761-0793, Japan.'}]",Molecular and clinical oncology,['10.3892/mco.2020.2159']
1813,33194212,Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders.,"Background


Pragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is a lack of empirical research that addresses ethical issues generated by pragmatic CRTs in hemodialysis.
Objective


To identify stakeholder perceptions of ethical issues in pragmatic CRTs conducted in hemodialysis.
Design


Qualitative study using semi-structured interviews.
Setting


In-person or telephone interviews with an international group of stakeholders.
Participants


Stakeholders (clinical investigators, methodologists, ethicists and research ethics committee members, and other knowledge users) who had been involved in the design or conduct of a pragmatic individual patient or cluster randomized trial in hemodialysis, or their role would require them to review and evaluate pragmatic CRTs in hemodialysis.
Methods


Interviews were conducted in-person or over the telephone and were audio-recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts and field notes were analyzed using a thematic analysis approach.
Results


Sixteen interviews were conducted with 19 individuals. Interviewees were largely drawn from North America (84%) and were predominantly clinical investigators (42%). Six themes were identified in which pragmatic CRTs in hemodialysis raise ethical issues: (1) patients treated with hemodialysis as a vulnerable population, (2) appropriate approaches to informed consent, (3) research burdens, (4) roles and responsibilities of gatekeepers, (5) inequities in access to research, and (6) advocacy for patient-centered research and outcomes.
Limitations


Participants were largely from North America and did not include research staff, who may have differing perspectives.
Conclusions


The six themes reflect concerns relating to individual rights, but also the need to consider population-level issues. To date, concerns regarding inequity of access to research and the need for patient-centered research have received less coverage than other, well-known, issues such as consent. Pragmatic CRTs offer a potential approach to address equity concerns and we suggest future ethical analyses and guidance for pragmatic CRTs in hemodialysis embed equity considerations within them. We further note the potential for the co-creation of health data infrastructure with patients which would aid care but also facilitate patient-centered research. These present results will inform planned future guidance in relation to the ethical design and conduct of pragmatic CRTs in hemodialysis.
Trial Registration


Registration is not applicable as this is a qualitative study.",2020,Pragmatic CRTs offer a potential approach to address equity concerns and we suggest future ethical analyses and guidance for pragmatic CRTs in hemodialysis embed equity considerations within them.,"['Participants\n\n\nStakeholders (clinical investigators, methodologists, ethicists and research ethics committee members, and other knowledge users) who had been involved in the design or conduct of a pragmatic individual patient or cluster randomized trial in hemodialysis, or their role would require them to review and evaluate pragmatic CRTs in hemodialysis', 'Limitations\n\n\nParticipants were largely from North America and did not include research staff, who may have differing perspectives', 'pragmatic CRTs conducted in hemodialysis', 'Hemodialysis Care', 'Results\n\n\nSixteen interviews were conducted with 19 individuals']",[],[],"[{'cui': 'C0008961', 'cui_str': 'Clinical Investigator'}, {'cui': 'C0086267', 'cui_str': 'Ethics Consultants'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C4273579', 'cui_str': 'Hemodialysis care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",[],[],16.0,0.0593497,Pragmatic CRTs offer a potential approach to address equity concerns and we suggest future ethical analyses and guidance for pragmatic CRTs in hemodialysis embed equity considerations within them.,"[{'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Nicholls', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Carroll', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Weijer', 'Affiliation': 'Department of Philosophy, Western University, London, Canada.'}, {'ForeName': 'Cory E', 'Initials': 'CE', 'LastName': 'Goldstein', 'Affiliation': 'Department of Philosophy, Western University, London, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Brehaut', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Manish M', 'Initials': 'MM', 'LastName': 'Sood', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Jaishi', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Basile', 'Affiliation': 'Research Ethics and Compliance, Western University, London, Canada.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Grimshaw', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Department of Epidemiology and Biostatistics, Western University, London, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Canadian journal of kidney health and disease,['10.1177/2054358120964119']
1814,33194354,"A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care.","Objectives


To examine the feasibility and preliminary effectiveness of (1) combining cognitive training, mind-body physical exercise, and nurse-led risk factor modification (CPR), (2) nurse-led risk factor modification (RFM), and (3) health advice (HA) on reducing cognitive decline among older adults with mild cognitive impairment (MCI).
Methods


It was a 3-arm open-labeled pilot randomized controlled trial in the primary care setting in Hong Kong. Nineteen older adults with MCI were randomized to either CPR ( n  = 6), RFM ( n  = 7), or HA ( n  = 6) for 6 months. The primary outcome was the feasibility of the study. Secondary outcomes included the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), the Montreal Cognitive Assessment Hong Kong version (HK-MoCA), the Clinical Dementia Rating (CDR), the Disability Assessment for Dementia (DAD), quality of life, depression, anxiety, physical activity, health service utilization, and diet.
Results


Nineteen out the 98 potential patients were recruited, with a recruitment rate of 19% (95% CI [12-29]%,  P  = 0.243). The adherence rate of risk factor modification was 89% (95% CI [65-98]%,  P  = 0.139) for CPR group and 86% (95% CI [63-96]%,  P  = 0.182) for RFM group. In the CPR group, 53% (95% CI [36-70]%,  P  = 0.038) of the Tai Chi exercise sessions and 54% (95% CI [37-71]%,  P  = 0.051) of cognitive sessions were completed. The overall dropout rate was 11% (95% CI [2-34]%,  P  = 0.456). Significant within group changes were observed in HK-MoCA in RFM (4.50 ± 2.59,  P  = 0.008), cost of health service utilization in CPR (-4000, quartiles: -6800 to -200,  P  = 0.043), fish and seafood in HA (-1.10 ± 1.02,  P  = 0.047), and sugar in HA (2.69 ± 1.80,  P  = 0.015). Group × time interactions were noted on HK-MoCA favoring the RFM group ( P  = 0.000), DAD score favoring CPR group ( P  = 0.027), GAS-20 favoring CPR group ( P  = 0.026), number of servings of fish and seafood ( P  = 0.004), and sugar ( P  < 0.001) ate per day.
Conclusions


In this pilot study, RFM and the multi-domain approach CPR were feasible and had preliminary beneficial effects in older adults with MCI in primary care setting in Hong Kong.
Trial registration


Chinese Clinical Trial Registry (ChiCTR1800015324).",2020,"Group × time interactions were noted on HK-MoCA favoring the RFM group ( P  = 0.000), DAD score favoring CPR group ( P  = 0.027), GAS-20 favoring CPR group ( P  = 0.026), number of servings of fish and seafood ( P  = 0.004), and sugar ( P  < 0.001) ate per day.
","['older adults with mild cognitive impairment (MCI', 'primary care setting in Hong Kong', 'older adults with MCI in primary care setting in Hong Kong', 'Nineteen older adults with MCI', 'older adults with mild cognitive impairment in primary care']","['RFM', 'cognitive training, mind-body physical exercise, and nurse-led risk factor modification (CPR), (2) nurse-led risk factor modification (RFM), and (3) health advice (HA', 'CPR', 'combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification']","['HK-MoCA in RFM', 'DAD score', 'overall dropout rate', 'HK-MoCA', 'number of servings of fish and seafood', 'adherence rate of risk factor modification', ""Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), the Montreal Cognitive Assessment Hong Kong version (HK-MoCA), the Clinical Dementia Rating (CDR), the Disability Assessment for Dementia (DAD), quality of life, depression, anxiety, physical activity, health service utilization, and diet"", 'cost of health service utilization']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0206208', 'cui_str': 'Seafood'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",98.0,0.172314,"Group × time interactions were noted on HK-MoCA favoring the RFM group ( P  = 0.000), DAD score favoring CPR group ( P  = 0.027), GAS-20 favoring CPR group ( P  = 0.026), number of servings of fish and seafood ( P  = 0.004), and sugar ( P  < 0.001) ate per day.
","[{'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Allen T C', 'Initials': 'ATC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Regina W S', 'Initials': 'RWS', 'LastName': 'Sit', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Eric K P', 'Initials': 'EKP', 'LastName': 'Lee', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jennifer Y S', 'Initials': 'JYS', 'LastName': 'Tiu', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Linda C W', 'Initials': 'LCW', 'LastName': 'Lam', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Samuel Y S', 'Initials': 'SYS', 'LastName': 'Wong', 'Affiliation': 'Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, Chinese University of Hong Kong, Hong Kong, China.'}]",PeerJ,['10.7717/peerj.9845']
1815,33194402,A 14 immune-related gene signature predicts clinical outcomes of kidney renal clear cell carcinoma.,"Kidney renal clear cell carcinoma (KIRC) is the leading cause of kidney cancer-related deaths. Currently, there are no studies in tumor immunology investigating the use of signatures as a predictor of overall survival in KIRC patients. Our study attempts to establish an immune-related gene risk signature to predict clinical outcomes in KIRC. A total of 528 patients from The Cancer Genome Atlas (TCGA) database were included in our analysis and randomly divided into training ( n  = 315) and testing sets ( n  = 213). We collected 1,534 immune-related genes from the Immunology Database and Analysis Portal as candidates to construct our signature. LASSO-COX was used to find gene models with the highest predictive ability. We used survival and Cox analysis to test the model's independent prognostic ability. Univariate analysis identified 650 immune-related genes with prognostic abilities. After 1,000 iterations, we choose 14 of the most frequent and stable immune-related genes as our signature. We found that the signature was associated with M stage, T stage, and pathological staging. More importantly, the signature can independently predict clinical prognosis in KIRC patients. Gene Set Enrichment Analysis (GSEA) showed an association between our signature and critical metabolism pathways. Our research established a model based upon 14 immune-related genes that predicted the prognosis of KIRC patients based on tumor immune microenvironments.",2020,"Currently, there are no studies in tumor immunology investigating the use of signatures as a predictor of overall survival in KIRC patients.","['kidney renal clear cell carcinoma', '528 patients from The Cancer Genome Atlas (TCGA) database', 'Kidney renal clear cell carcinoma (KIRC', 'KIRC patients']",[],[],"[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],[],528.0,0.0489196,"Currently, there are no studies in tumor immunology investigating the use of signatures as a predictor of overall survival in KIRC patients.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Department of Oncology, The People's Hosipital of Hanchuan City, Hanchuan, Hubei, China.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Department of Oncology, The People's Hosipital of Hanchuan City, Hanchuan, Hubei, China.""}]",PeerJ,['10.7717/peerj.10183']
1816,33194447,Deep-learning convolutional neural networks with transfer learning accurately classify COVID-19 lung infection on portable chest radiographs.,"Portable chest X-ray (pCXR) has become an indispensable tool in the management of Coronavirus Disease 2019 (COVID-19) lung infection. This study employed deep-learning convolutional neural networks to classify COVID-19 lung infections on pCXR from normal and related lung infections to potentially enable more timely and accurate diagnosis. This retrospect study employed deep-learning convolutional neural network (CNN) with transfer learning to classify based on pCXRs COVID-19 pneumonia ( N  = 455) on pCXR from normal ( N  = 532), bacterial pneumonia ( N  = 492), and non-COVID viral pneumonia ( N  = 552). The data was randomly split into 75% training and 25% testing, randomly. A five-fold cross-validation was used for the testing set separately. Performance was evaluated using receiver-operating curve analysis. Comparison was made with CNN operated on the whole pCXR and segmented lungs. CNN accurately classified COVID-19 pCXR from those of normal, bacterial pneumonia, and non-COVID-19 viral pneumonia patients in a multiclass model. The overall sensitivity, specificity, accuracy, and AUC were 0.79, 0.93, and 0.79, 0.85 respectively (whole pCXR), and were 0.91, 0.93, 0.88, and 0.89 (CXR of segmented lung). The performance was generally better using segmented lungs. Heatmaps showed that CNN accurately localized areas of hazy appearance, ground glass opacity and/or consolidation on the pCXR. Deep-learning convolutional neural network with transfer learning accurately classifies COVID-19 on portable chest X-ray against normal, bacterial pneumonia or non-COVID viral pneumonia. This approach has the potential to help radiologists and frontline physicians by providing more timely and accurate diagnosis.",2020,Portable chest X-ray (pCXR) has become an indispensable tool in the management of Coronavirus Disease 2019 (COVID-19) lung infection.,"[' N  = 455) on pCXR from normal ( N  = 532), bacterial pneumonia ( N  = 492), and non-COVID viral pneumonia ( N  = 552']","['deep-learning convolutional neural network (CNN) with transfer learning to classify based on pCXRs COVID-19 pneumonia', 'Portable chest X-ray (pCXR']","['overall sensitivity, specificity, accuracy, and AUC']","[{'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032310', 'cui_str': 'Viral pneumonia'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0161258,Portable chest X-ray (pCXR) has become an indispensable tool in the management of Coronavirus Disease 2019 (COVID-19) lung infection.,"[{'ForeName': 'Shreeja', 'Initials': 'S', 'LastName': 'Kikkisetti', 'Affiliation': 'Radiology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Radiology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Beiyi', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Radiology, State University of New York at Stony Brook, Stony Brook, NY, USA.'}, {'ForeName': 'Haifang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Radiology, State University of New York at Stony Brook, Stony Brook, NY, USA.'}, {'ForeName': 'Tim Q', 'Initials': 'TQ', 'LastName': 'Duong', 'Affiliation': 'Radiology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}]",PeerJ,['10.7717/peerj.10309']
1817,33194485,Comparison of Efficacy of Dexamethasone and Methylprednisolone in Improving PaO2/FiO2 Ratio Among COVID-19 Patients.,"Introduction Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the reason for the global pandemic that started from Wuhan, China, in December 2019, known as coronavirus diseases 2019 (COVID-19). Acute respiratory distress syndrome happened in COVID-19 not just because of uncontrolled viral replication but also because of an uncontrolled immune reaction from the host. That's why antiviral and anti-inflammatory treatments have become an increasing concern for clinicians. Methods A retrospective quasi-experimental study design was used to assess the effectiveness of methylprednisolone and dexamethasone in the improvement of PaO 2 /FiO 2  (P/F) ratio in COVID-19 patients. We included 60 participants for this study by using a convenient sampling technique and divided them into two groups with 30 patients in each group. Group 1 was given dexamethasone 8 mg twice daily, and group 1 given methylprednisolone 40 mg twice daily for eight days. We recorded C-reactive protein (CRP), serum ferritin level, and P/F ratio before administration of both drugs and after administration of drugs for eight days. We used the paired t-test to assess the effect of both drugs on the P/F ratio of participants. Results The initial mean CRP in group 1 was 110.34, which reduced to 19.45 after administration of dexamethasone; similarly, the CRP in group 2 was 108.65, which reduced to 43.82 after administering methylprednisolone for eight days. In P/F ratio improvement, the calculated significance value for dexamethasone (p=0.000) was less than the table value at 0.05 in all sections, p-value for methylprednisolone (p=0.009) was also less than the table value at 0.05, which shows that both dexamethasone and methylprednisolone were effective in improving P/F ratio. Calculated p-value for dexamethasone (p=0.000) was lower than the calculated p-value for methylprednisolone (p=0.009), which shows that dexamethasone is more effective as compare to methylprednisolone. Conclusions Steroid therapy is effective in controlling inflammation markers, and especially dexamethasone is significantly effective in improving the P/F ratio in COVID-19 patients.",2020,"In P/F ratio improvement, the calculated significance value for dexamethasone (p=0.000) was less than the table value at 0.05 in all sections, p-value for methylprednisolone (p=0.009) was also less than the table value at 0.05, which shows that both dexamethasone and methylprednisolone were effective in improving P/F ratio.","['COVID-19 Patients', 'COVID-19 patients', '60 participants for this study by using a convenient sampling technique and divided them into two groups with 30 patients in each group']","['dexamethasone', 'methylprednisolone', 'methylprednisolone and dexamethasone', 'Dexamethasone and Methylprednisolone']","['PaO2/FiO2 Ratio', 'C-reactive protein (CRP), serum ferritin level, and P/F ratio', 'initial mean CRP']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.0302511,"In P/F ratio improvement, the calculated significance value for dexamethasone (p=0.000) was less than the table value at 0.05 in all sections, p-value for methylprednisolone (p=0.009) was also less than the table value at 0.05, which shows that both dexamethasone and methylprednisolone were effective in improving P/F ratio.","[{'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Rana', 'Affiliation': 'Internal Medicine, Bahria International Hospital, Lahore, PAK.'}, {'ForeName': 'Mubashar', 'Initials': 'M', 'LastName': 'Hashmi', 'Affiliation': 'Internal Medicine, Bahria International Hospital, Lahore, PAK.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Qayyum', 'Affiliation': 'Internal Medicine, Bahria International Hospital, Lahore, PAK.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Pervaiz', 'Affiliation': 'Internal Medicine, Bahria International Hospital, Lahore, PAK.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Internal Medicine, Bahria International Hospital, Lahore, PAK.'}, {'ForeName': 'Muhammad Faisal', 'Initials': 'MF', 'LastName': 'Munir', 'Affiliation': 'Medical Education and Simulation, Bahria International Hospital, Lahore, PAK.'}, {'ForeName': 'Muhammad Muneeb', 'Initials': 'MM', 'LastName': 'Ullah Saif', 'Affiliation': 'Medical Education and Simulation, Bahria International Hospital, Lahore, PAK.'}]",Cureus,['10.7759/cureus.10918']
1818,33194505,An Erythritol-Sweetened Beverage Induces Satiety and Suppresses Ghrelin Compared to Aspartame in Healthy Non-Obese Subjects: A Pilot Study.,"Despite the reduced caloric content of artificially sweetened beverages (ASBs) relative to those sweetened with sucrose, consumption of ASBs fail to consistently decrease the risk of obesity and associated diseases. This failure may be due to the inability of ASBs to effectively reduce appetite and hence overall caloric intake. A variety of non-nutritive sweeteners (NNS), however, remain to be screened for effectiveness in promoting satiety and reducing calorie consumption. Erythritol is well-tolerated, low-calorie sugar alcohol widely used as a sugar substitute. It is unique among NNS due to its low sweetness index relative to glucose, meaning that it is typically served at much higher concentrations than other common NNS. Animal and human studies have noted correlations between osmolarity, satiety, and levels of satiety hormones, independent of the effects of sweetness or nutritive value. We hypothesized that consumption of a beverage sweetened with erythritol to the sweetness and osmolarity of a common soft drink will improve self-reported satiety and more strongly affect the magnitude of changes in the hormone ghrelin than would an iso sweet beverage sweetened only with aspartame, a sweetener with a high sweetness index relative to glucose. Using a randomized double-blind crossover trial, we found that serum ghrelin was significantly decreased after consumption of an erythritol-sweetened beverage compared to aspartame. Likewise, consumption of the erythritol-sweetened beverage increased various measures of satiety in volunteers. Knowledge gained from this project demonstrates that high-osmolarity NNS may be useful in formulating ASBs that are satiating and low in calories.",2020,"Likewise, consumption of the erythritol-sweetened beverage increased various measures of satiety in volunteers.","['volunteers', 'Healthy Non-Obese Subjects']","['Erythritol-Sweetened Beverage Induces Satiety and Suppresses Ghrelin', 'Aspartame']",['risk of obesity and associated diseases'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0014757', 'cui_str': 'Erythritol'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0459832,"Likewise, consumption of the erythritol-sweetened beverage increased various measures of satiety in volunteers.","[{'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Sorrentino', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Palm', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Motwani', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Butterfield', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Archer', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Coy', 'Initials': 'C', 'LastName': 'Heldermon', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Medicine, University of Florida College of Medicine, Jacksonville, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Brantly', 'Affiliation': 'Medicine, University of Florida College of Medicine, Gainesville, USA.'}]",Cureus,['10.7759/cureus.11409']
1819,33194565,Randomized clinical trial comparing skin closure with tissue adhesives  vs  subcuticular suture after robotic urogynecologic procedures.,"BACKGROUND


Skin closure techniques during minimally-invasive gynecologic surgery is largely based on surgeon preference. The optimum technique would theoretically be safe, rapid, inexpensive, and result in good cosmetic appearance. Cyanoacrylate tissue adhesive (Dermabond )  may be a comparable and safe option for port site closure as compared with subcuticular suture. In this randomized clinical trial, we hypothesized that operative time for skin closure would be less than subcuticular suture during robotic urogynecologic procedures.
AIM


To compare skin closure during robotic urogynecologic surgeries for tissue adhesives and subcuticular suture.
METHODS


Fifty female subjects > 18 years of age undergoing robotic urogynecologic procedures were randomized to have port site closure with either cyanoacrylate tissue adhesive ( n  = 25) or subcuticular suture ( n  = 25). All procedures and postoperative evaluations were performed by the same board certified Female Pelvic Medicine and Reconstructive Surgeon. Incisional closure time was recorded. Each subject was followed for 12-wk postoperatively. Incision cosmesis was evaluated using the Stony Brook Scar Evaluation Scale.
RESULTS


A total of 47 subjects (cyanoacrylate group,  n  = 23; suture group,  n  = 24) completed the 12-wk postoperative evaluation. Closure time was significantly less ( P  < 0.0005) using cyanoacrylate tissue adhesive (5.4 ± 2.0 min) than subcuticular suture (24.9 ± 5.6 min). Cosmesis scores were significantly higher in the cyanoacrylate tissue adhesive group than subcuticular suture ( P  = 0.025). No differences were found between bleeding, infection, or dehiscence ( P  = 1.00,  P  = 0.609,  P  = 0.234, respectively). No statistical demographical differences existed between the two study arms.
CONCLUSION


Our study supported our original hypothesis that cyanoacrylate tissue adhesive for port site closure during robotic urogynecolgic procedures uses less time than with subcuticular suture. Our study also supports that tissue adhesive is comparable to cosmetic outcome while not jeopardizing rates of bleeding, infection, or dehiscence.",2020,"No differences were found between bleeding, infection, or dehiscence ( P  = 1.00,  P  = 0.609,  P  = 0.234, respectively).","['Fifty female subjects > 18 years of age undergoing robotic urogynecologic procedures', '47 subjects (cyanoacrylate group,  n  = 23; suture group,  n  = 24) completed the 12-wk postoperative evaluation']","['skin closure with tissue adhesives  vs  subcuticular suture', 'port site closure with either cyanoacrylate tissue adhesive ( n  = 25) or subcuticular suture', 'Cyanoacrylate tissue adhesive (Dermabond ', 'robotic urogynecologic surgeries', 'subcuticular suture']","['bleeding, infection, or dehiscence', 'Cosmesis scores', 'Incision cosmesis', 'Stony Brook Scar Evaluation Scale', 'Closure time', 'Incisional closure time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040277', 'cui_str': 'Tissue adhesives'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",50.0,0.0180436,"No differences were found between bleeding, infection, or dehiscence ( P  = 1.00,  P  = 0.609,  P  = 0.234, respectively).","[{'ForeName': 'Sunetris', 'Initials': 'S', 'LastName': 'Fluellen', 'Affiliation': 'Department of Obstetrics and Gynecology, Ascension St John Hospital and Medical Center, Detroit, MI 48236, United States.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Mackey', 'Affiliation': 'Department of Obstetrics and Gynecology, Ascension St John Hospital and Medical Center, Detroit, MI 48236, United States. kyle.mackey@ascension.org.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hagglund', 'Affiliation': 'Medical Research, Ascension St John Hospital and Medical Center, Detroit, MI 48236, United States.'}, {'ForeName': 'Muhammad Faisal', 'Initials': 'MF', 'LastName': 'Aslam', 'Affiliation': 'Department of Obstetrics and Gynecology, Ascension St John Hospital and Medical Center, Detroit, MI 48236, United States.'}]",World journal of methodology,['10.5662/wjm.v10.i1.1']
1820,33194589,Application of MRI Radiomics-Based Machine Learning Model to Improve Contralateral BI-RADS 4 Lesion Assessment.,"Objective


This study aimed to explore the potential of magnetic resonance imaging (MRI) radiomics-based machine learning to improve assessment and diagnosis of contralateral Breast Imaging Reporting and Data System (BI-RADS) category 4 lesions in women with primary breast cancer.
Materials and Methods


A total of 178 contralateral BI-RADS 4 lesions (97 malignant and 81 benign) collected from 178 breast cancer patients were involved in our retrospective dataset. T1 + C and T2 weighted images were used for radiomics analysis. These lesions were randomly assigned to the training (n = 124) dataset and an independent testing dataset (n = 54). A three-dimensional semi-automatic segmentation method was performed to segment lesions depicted on T2 and T1 + C images, 1,046 radiomic features were extracted from each segmented region, and a least absolute shrinkage and operator feature selection method reduced feature dimensionality. Three support vector machine (SVM) classifiers were trained to build classification models based on the T2, T1 + C, and fusion image features, respectively. The diagnostic performance of each model was evaluated and tested using the independent testing dataset. The area under the receiver operating characteristic curve (AUC) was used as a performance metric.
Results


The T1+C image feature-based model and T2 image feature-based model yielded AUCs of 0.71 ± 0.07 and 0.69 ± 0.07 respectively, and the difference between them was not significant (P > 0.05). After fusing T1 + C and T2 imaging features, the proposed model's AUC significantly improved to 0.77 ± 0.06 (P < 0.001). The fusion model yielded an accuracy of 74.1%, which was higher than that of the T1 + C (66.7%) and T2 (59.3%) image feature-based models.
Conclusion


The MRI radiomics-based machine learning model is a feasible method to assess contralateral BI-RADS 4 lesions. T2 and T1 + C image features provide complementary information in discriminating benign and malignant contralateral BI-RADS 4 lesions.",2020,"The fusion model yielded an accuracy of 74.1%, which was higher than that of the T1 + C (66.7%) and T2 (59.3%) image feature-based models.
","['women with primary breast cancer', '178 contralateral BI-RADS 4 lesions (97 malignant and 81 benign) collected from 178 breast cancer patients']","['MRI Radiomics-Based Machine Learning Model', 'magnetic resonance imaging (MRI) radiomics-based machine learning']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1622900', 'cui_str': 'Data Systems'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],178.0,0.02998,"The fusion model yielded an accuracy of 74.1%, which was higher than that of the T1 + C (66.7%) and T2 (59.3%) image feature-based models.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'Department of Radiology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Radiology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Shengping', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Shandong Medical Imaging Research Institute, Shandong University, Jinan, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.531476']
1821,33194634,A Short-Term Effect of Wearable Technology-Based Lifestyle Intervention on Body Composition in Stage I-III Postoperative Breast Cancer Survivors.,"Background and Aim


A healthy body composition can improve the prognosis of breast cancer survivors. The study aimed to describe the body composition profile of breast cancer survivors and find out whether a short-term (3 months) wearable device-based lifestyle intervention had an effect on patients' body weight and body composition.
Methods


A before-and-after study was conducted on patients with stage I-III postoperative breast cancer, aged 18-70 years. Body composition was analyzed at baseline, and then patients went for a health education program. A wearable activity tracker and a goal of calorie consumption based on each individual's weight were provided to each participant, and they were required to be equipped for 90 days. After 3 months, body composition was analyzed again.
Results


Of 113 patients who completed the study, 65.49% showed a normal body mass index (BMI) at baseline assessment, 71.68% had a body fat percentage of more than 30%, and 41.59% had less skeleton muscle mass. During the intervention, the daily step count was 8,851.28 ± 2,399.31, and 59.21% reached the set goal calorie consumption. After a 3-month intervention, the patients had a significant reduction in body weight, fat mass, BMI, body fat percentage, and visceral fat area, but not in protein mass and skeleton muscle mass. Patients of different age, molecular classification, and therapy benefited from the intervention.
Conclusion


Wearable technology with body composition analysis and health education for breast cancer survivors may help reduce weight and improve body composition even in a short time.
Clinical Trial Registration


http://www.chictr.org.cn/showproj.aspx?proj=40672, identifier ChiCTR1900024258.",2020,"After a 3-month intervention, the patients had a significant reduction in body weight, fat mass, BMI, body fat percentage, and visceral fat area, but not in protein mass and skeleton muscle mass.","['breast cancer survivors', 'Stage I-III Postoperative Breast Cancer Survivors', 'patients with stage I-III postoperative breast cancer, aged 18-70 years']","['short-term (3 months) wearable device-based lifestyle intervention', 'Wearable Technology-Based Lifestyle Intervention']","['Body Composition', 'Body composition', 'normal body mass index (BMI', 'body composition', 'body weight, fat mass, BMI, body fat percentage, and visceral fat area']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",113.0,0.0251883,"After a 3-month intervention, the patients had a significant reduction in body weight, fat mass, BMI, body fat percentage, and visceral fat area, but not in protein mass and skeleton muscle mass.","[{'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zezhou', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jiajian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Ruochu Information Technology Co., Ltd., Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Huami Information Technology Co., Ltd., Beijing, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Cancer Prevention, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.563566']
1822,33194636,The Prognostic Prediction Value of Systemic Inflammation Score and the Development of a Nomogram for Patients With Surgically Treated Breast Cancer.,"Background:  Systemic inflammation score (SIS) has been verified as a novel prognostic indicator in several cancer types. However, its prognostic value in breast cancer remains unknown. Furthermore, a nomogram based on SIS is yet to be constructed for breast cancer. We conducted this study to explore the association between SIS and prognosis of breast cancer, and to construct a good prognostic nomogram model.  Methods:  A total of 1,180 breast cancer patients who underwent curative surgery between December 2010 and January 2013 were recruited. They were randomly assigned to the training set ( n  = 944) or the validation set ( n  = 236). All patient blood samples were collected within 1 week prior to operation. According to previous reports, SIS was calculated for all patients, who were then classified into two groups: high-SIS and low-SIS. The Kaplan-Meier method was employed for survival analyses, and univariate and multivariate analyses (Cox proportional hazards regression model) were used for prognostic assessment. A nomogram was constructed based on the results of multivariate analysis. Calibration curves and concordance index (C-index) were compiled to determine predictive and discriminatory capacity.  Results:  In the training set, the median follow-up time was 6.07 years. Patients in the high-SIS group had an average OS time of 68.05 months, which is shorter than that of the low-SIS group (72.87 months;  P  = 0.033). Patients in the high-SIS group had average RFS and DMFS times of 56.04 and 54.46 months, respectively, which are shorter than those of the low-SIS group (60.85 and 59.47 months, respectively;  P  = 0.247 and  P  = 0.032). Univariate and multivariate analyses revealed SIS to be an independent prognostic factor for OS and DMFS time. The nomogram for the training set indicated OS and DMFS C-indexes of 0.794 (95% CI, 0.772-0.816) and 0.712 (95% CI, 0.684-0.740), respectively. In the validation set, the OS and DMFS C-indexes were 0.889 (95% CI, 0.845-0.933) and 0.696 (95%. CI, 0.611-0.781), respectively.  Conclusions:  SIS was confirmed as an independent prognostic predictor among patients with breast cancer who had undergone surgery with curative intent. Higher preoperative SIS may indicate higher risk of metastasis and shorter overall survival time. The prognostic nomogram based on SIS was dependable for breast cancer patients who underwent curative surgery.",2020,"Patients in the high-SIS group had average RFS and DMFS times of 56.04 and 54.46 months, respectively, which are shorter than those of the low-SIS group (60.85 and 59.47 months, respectively;  P  = 0.247 and  P  = 0.032).","['Patients With Surgically Treated Breast Cancer', '1,180 breast cancer patients who underwent curative surgery between December 2010 and January 2013 were recruited', 'patients with breast cancer who had undergone surgery with curative intent', 'breast cancer patients who underwent curative surgery']",[],"['overall survival time', 'average RFS and DMFS times', 'average OS time', 'Calibration curves and concordance index (C-index', 'OS and DMFS C-indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1180.0,0.0278694,"Patients in the high-SIS group had average RFS and DMFS times of 56.04 and 54.46 months, respectively, which are shorter than those of the low-SIS group (60.85 and 59.47 months, respectively;  P  = 0.247 and  P  = 0.032).","[{'ForeName': 'Zhang-Zan', 'Initials': 'ZZ', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chen-Ge', 'Initials': 'CG', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xi-Wen', 'Initials': 'XW', 'LastName': 'Bi', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhong-Yu', 'Initials': 'ZY', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zhen-Yu', 'Initials': 'ZY', 'LastName': 'He', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jia-Jia', 'Initials': 'JJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.563731']
1823,33194699,Percutaneous Radiofrequency Ablation Combined With Transarterial Chemoembolization Plus Sorafenib for Large Hepatocellular Carcinoma Invading the Portal Venous System: A Prospective Randomized Study.,"Background


Hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) portends a worse prognosis. The objective of this study was to compare the efficacy of percutaneous radiofrequency ablation (RFA) combined with transarterial chemoembolization (TACE) plus sorafenib to that of the most commonly utilized regimen of TACE plus sorafenib in large HCCs with type I/II PVTT.
Methods


An open-label, single-center, prospective, randomized trial of participants with tumors ≥5 cm and type I/II PVTT was performed. Participants with previously untreated HCCs were divided into two groups: RFA + cTACE + sorafenib (study group, n = 40) and cTACE + sorafenib (control group, n = 40). The primary endpoint was the objective response rate (ORR), the secondary endpoints included the overall survival (OS); time to progression (TTP); and toxicity. Prognostic factors were analyzed using cox-regression analysis.
Results


80 patients were enrolled into this study with integrated clinical data. Under a median follow-up of 506 days, the median age was 57.5 years (range: 28-80 years). The ORR of study group was higher than control group (70% vs 22.5%,  p <0.001). Furthermore, the median OS of study group was superior to that of control group (468 days vs 219 days, HR: 0.44 [95% CI: 0.25-0.78], P = 0.005). Adverse events occurred with 100% probability in both groups (p>0.99), but no treatment-related deaths were recorded. Tumor encapsulation and attaining treatment response predict favorable OS in a multivariate Cox model. The rates of adverse events in both groups were 100% (p>0.99). There were no treatment-related deaths.
Conclusions


RFA combined with TACE plus sorafenib is a safe, well-tolerated three-modality treatment for large HCCs with types I/II PVTT, and it demonstrated better efficacy than TACE plus sorafenib alone.",2020,"Adverse events occurred with 100% probability in both groups (p>0.99), but no treatment-related deaths were recorded.","['80 patients were enrolled into this study with integrated clinical data', 'Participants with previously untreated HCCs', 'participants with tumors', 'Large Hepatocellular Carcinoma Invading the Portal Venous System']","['cTACE + sorafenib', 'TACE plus sorafenib', 'Percutaneous Radiofrequency Ablation Combined With Transarterial Chemoembolization Plus Sorafenib', 'percutaneous radiofrequency ablation (RFA) combined with transarterial chemoembolization (TACE) plus sorafenib', 'RFA + cTACE + sorafenib']","['rates of adverse events', 'overall survival (OS); time to progression (TTP); and toxicity', 'Adverse events', 'objective response rate (ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0226727', 'cui_str': 'Portal venous system structure'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",80.0,0.0554464,"Adverse events occurred with 100% probability in both groups (p>0.99), but no treatment-related deaths were recorded.","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jinglong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaodi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wendong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, Beijing, China.'}, {'ForeName': 'Bozhi', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Cancer Center, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.578633']
1824,33194700,A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable  KRAS  Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER.,"Introduction


JUNIPER compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, with erlotinib in patients with non-small cell lung cancer (NSCLC) harboring a Kirsten rat sarcoma ( KRAS ) mutation.
Methods


JUNIPER was a Phase III, multicenter, randomized, open-label trial of abemaciclib versus erlotinib in patients with stage IV NSCLC and a detectable mutation in codons 12 or 13 of the  KRAS  oncogene, who progressed after platinum-based chemotherapy and 1 additional therapy (could include immune checkpoint inhibitor therapy). Randomized patients (3:2) received either 200 mg abemaciclib twice daily or 150 mg erlotinib once daily with best supportive care until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS); secondary endpoints included overall response rate (ORR), progression-free survival (PFS), and safety.
Results


Between December 2014 and April 2017, 453 patients were randomly assigned to receive abemaciclib (N = 270) or erlotinib (N = 183). Median OS was 7.4 months (95% confidence interval [CI]: 6.5, 8.8) with abemaciclib and 7.8 months (95% CI: 6.4, 9.5) with erlotinib (hazard ratio [HR] = 0.968 [95% CI: 0.768, 1.219]; p = .77). Median PFS was 3.6 months (95% CI: 2.8, 3.8) with abemaciclib and 1.9 months (95% CI: 1.9, 2.0) with erlotinib (HR = 0.583 [95% CI: 0.470, 0.723]; p <.000001). ORR was 8.9% and 2.7% (p = .010), and the disease control rate was 54.4% and 31.7% (p <.001) with abemaciclib and erlotinib, respectively. Safety results reflected the known safety profiles of abemaciclib and erlotinib.
Conclusions


In this study, the primary endpoint of OS was not met; PFS and ORR were improved with manageable toxicity in the abemaciclib arm. The increases in response rates and PFS support further investigation of abemaciclib in other NSCLC subpopulations or in combination with other agents.
Clinical Trial Registration


www.ClinicalTrials.gov, identifier: NCT02152631.",2020,"ORR was 8.9% and 2.7% (p = .010), and the disease control rate was 54.4% and 31.7% (p <.001) with abemaciclib and erlotinib, respectively.","['Results\n\n\nBetween December 2014 and April 2017', '453 patients', 'Patients with Stage IV Non-small Cell Lung Cancer With a Detectable  KRAS', 'patients with non-small cell lung cancer (NSCLC) harboring a Kirsten rat sarcoma ( KRAS ) mutation', 'patients with stage IV NSCLC and a detectable mutation in codons 12 or 13 of the  KRAS  oncogene, who progressed after platinum-based chemotherapy and 1 additional therapy (could include immune checkpoint inhibitor therapy']","['Abemaciclib Versus Erlotinib', '200 mg abemaciclib twice daily or 150 mg erlotinib', 'abemaciclib versus erlotinib', 'erlotinib', 'abemaciclib']","['overall response rate (ORR), progression-free survival (PFS), and safety', 'disease control rate', 'overall survival (OS', 'Median PFS', 'ORR', 'Mutation', 'Median OS', 'manageable toxicity']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0009221', 'cui_str': 'Codon'}, {'cui': 'C0029016', 'cui_str': 'Oncogene'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",453.0,0.189224,"ORR was 8.9% and 2.7% (p = .010), and the disease control rate was 54.4% and 31.7% (p <.001) with abemaciclib and erlotinib, respectively.","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Thoracic Oncology Department, Toulouse University Hospital, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Multidisciplinary Oncology and Innovative Therapies Department, Aix-Marseille University, INSERM, CNRS, CRCM, Assistance Publque Hôspitaux de Marseille (AP-HM), Marseille, France.'}, {'ForeName': 'Konstantin H', 'Initials': 'KH', 'LastName': 'Dragnev', 'Affiliation': 'Department of Medicine, Norris Cotton Cancer Center, Dartmouth-Hitchcock, Lebanon, NH, United States.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Koczywas', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope, Duarte, CA, United States.'}, {'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Göskel', 'Affiliation': 'Department of Internal Medical Sciences, Ege University, (Bornova), Izmir, Turkey.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Cortot', 'Affiliation': 'Thoracic Oncology Department, University of Lille, CHU Lille, Lille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Respiratory Medicine Department, Hospices Civils de Lyon, University of Lyon, Lyon, France.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Wesseler', 'Affiliation': 'Department of Thoracic Oncology, Asklepios Klinikum Harburg, Hamburg, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Bischoff', 'Affiliation': 'Department of Thoracic Oncology, Thoraxklinik-Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Department of Medical Oncology, Catalan Institute of Oncology, (L'Hospitalet), Barcelona, Spain.""}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Hematology-Oncology, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Lung Tumor Medical (Cancer) Center, Shanghai Chest Hospital, Shanghai (Jiao Tong University), Shanghai, China.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Taus', 'Affiliation': 'Department of Medical Oncology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Medical Oncology Department, Hospital Regional Universitario Málaga, IBIMA, Málaga, Spain.'}, {'ForeName': 'Shawn T', 'Initials': 'ST', 'LastName': 'Estrem', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Sameera R', 'Initials': 'SR', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Turner', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Gerard Joseph', 'Initials': 'GJ', 'LastName': 'Oakley', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Karla C', 'Initials': 'KC', 'LastName': 'Hurt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Alan Y', 'Initials': 'AY', 'LastName': 'Chiang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Anwar M', 'Initials': 'AM', 'LastName': 'Hossain', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'John', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medicine, Hospital Universitario 12 de Octubre, CNIO and Universidad Complutense, Madrid, Spain.'}]",Frontiers in oncology,['10.3389/fonc.2020.578756']
1825,33194760,Prognostic Nomograms for Predicting Overall Survival and Cancer-Specific Survival of Patients With Early Onset Colon Adenocarcinoma.,"Background


The incidence of colon cancer in young patients is on the rise, of which adenocarcinoma is the most common pathological type. However, a reliable nomogram for early onset colon adenocarcinoma (EOCA) to predict prognosis is currently lacking. This study aims to develop nomograms for predicting the overall survival (OS) and cancer-specific survival (CSS) of patients with EOCA.
Methods


Patients diagnosed with EOCA from 2010 to 2015 were included and randomly assigned to training set and validation set. Cox regression models were used to evaluate prognosis and identify independent predictive factors, which were then utilized to establish the nomograms for predicting 3- and 5-year OS and CSS. The discrimination and calibration of nomograms were validated using the calibration plots, concordance index, receiver operating characteristics curve, and the decision curve analysis.
Results


A total of 2,348 patients were screened out, with 1,644 categorized into the training set and 704 into the validation set. Multivariate analysis demonstrated that gender, age, tumor size, T stage, M stage, regional node, tumor deposits, lung metastasis and perineural invasion were significantly correlated with OS and CSS. The calibration plots indicated that there was good consistency between the nomogram prediction and actual observation. The C-indices for training set of OS and CSS prediction nomograms were 0.735 (95% CI: 0.708-0.762) and 0.765 (95% CI: 0.739-0.791), respectively, whereas those for validation set were 0.736 (95% CI: 0.696-0.776) and 0.76 (95% CI: 0.722-0.798), respectively. The results of ROC analysis revealed the nomograms showed a good discriminate power. The 3- and 5-year DCA curves displayed superiority over TNM staging system with higher net benefit gains.
Conclusions


The nomograms established could effectively predict 3- and 5-year OS and CSS in EOCA patients, which assisted clinicians to evaluate prognosis more accurately and optimize treatment strategies.",2020,"The 3- and 5-year DCA curves displayed superiority over TNM staging system with higher net benefit gains.
","['Patients With Early Onset Colon Adenocarcinoma', 'Methods\n\n\nPatients diagnosed with EOCA from 2010 to 2015', 'patients with EOCA', 'young patients', '2,348 patients were screened out, with 1,644 categorized into the training set and 704 into the validation set']",[],"['tumor size, T stage, M stage, regional node, tumor deposits, lung metastasis and perineural invasion', 'Overall Survival and Cancer-Specific Survival', 'overall survival (OS) and cancer-specific survival (CSS', 'incidence of colon cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0338106', 'cui_str': 'Adenocarcinoma of colon'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",[],"[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0007591', 'cui_str': 'Cell division phase'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C5197703', 'cui_str': 'Tumor Deposit'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C1317608', 'cui_str': 'Perineural spread'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",2348.0,0.125091,"The 3- and 5-year DCA curves displayed superiority over TNM staging system with higher net benefit gains.
","[{'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'First Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'First Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Kaibo', 'Initials': 'K', 'LastName': 'Guo', 'Affiliation': 'First Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Shanming', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.595354']
1826,33194876,Use of Adjunctive Therapy in Acute Kawasaki Disease in Latin America.,"Objective:  To characterize the use of adjunctive therapy in Kawasaki disease (KD) in Latin America.  Methods:  The study included 1,418 patients from the Latin American KD Network (REKAMLATINA) treated for KD between January 1, 2009, and May 31, 2017.  Results:  Of these patients, 1,152 received only a single dose of IVIG, and 266 received additional treatment. Age at onset was similar in both groups (median 2 vs. 2.2 years, respectively). The majority of patients were male (58 vs. 63.9%) and were hospitalized with the first 10 days of fever (85.1 vs. 84.2%). The most common adjunctive therapy administered was steroids for IVIG-resistance, followed by additional doses of IVIG. The use of biologics such as infliximab was limited. KD patients who received adjunctive therapy were more likely to have a lower platelet count and albumin level as well as a higher Z score of the coronary arteries.  Conclusion:  This is the first report of adjunctive therapies for KD across Latin America. IVIG continues to be the initial and resistance treatment, however, steroids are also used and to a lesser extent, biological therapy such as infliximab. Future studies should address the barriers to therapy in children with acute KD throughout Latin America.",2020,KD patients who received adjunctive therapy were more likely to have a lower platelet count and albumin level as well as a higher Z score of the coronary arteries.  ,"['1,418 patients from the Latin American KD Network (REKAMLATINA) treated for KD between January 1, 2009, and May 31, 2017', 'children with acute KD throughout Latin America', 'Kawasaki disease (KD) in Latin America', 'Acute Kawasaki Disease in Latin America']","['Adjunctive Therapy', 'adjunctive therapy']",['platelet count and albumin level'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}]",1418.0,0.0346385,KD patients who received adjunctive therapy were more likely to have a lower platelet count and albumin level as well as a higher Z score of the coronary arteries.  ,"[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Fortuna-Reyna', 'Affiliation': 'Universidad Autónoma de Nuevo León, Hospital Universitario ""Dr. José Eleuterio González"", Monterrey, Mexico.'}, {'ForeName': 'Emelia V', 'Initials': 'EV', 'LastName': 'Bainto', 'Affiliation': 'University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Ulloa-Gutierrez', 'Affiliation': 'Servicio de Infectología, Hospital Nacional de Niños ""Dr. Carlos Sáenz Herrera"", San José, Costa Rica.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Garrido-García', 'Affiliation': 'Servicio de Cardiología, Instituto Nacional de Pediatría, Ciudad de México, Mexico.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Estripeaut', 'Affiliation': 'Servicio de Infectología, Hospital del Niño Dr. José Renán Esquivel, Ciudad Panamá, Panama.'}, {'ForeName': 'Olguita', 'Initials': 'O', 'LastName': 'Del Águila', 'Affiliation': 'Unidad de Infectología Pediátrica, Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru.'}, {'ForeName': 'Virgen', 'Initials': 'V', 'LastName': 'Gómez', 'Affiliation': 'Servicio de Infectología, Centro Médico Universidad Central del Este Hospital y Hospital Infantil ""Dr. Robert Reid Cabral"", Santo Domingo, Dominican Republic.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Faugier-Fuentes', 'Affiliation': 'Servicio de Reumatología, Hospital Infantil de México Federico Gómez, Ciudad de México, Mexico.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Miño-León', 'Affiliation': 'Servicio de Infectología, Hospital del Niño ""Francisco de Icaza Bustamante"", Guayaquil, Ecuador.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Beltrán', 'Affiliation': 'Servicio de Infectología, Clínica Colsanitas, Bogotá, Colombia.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Cofré', 'Affiliation': 'Servicio de Infectología, Hospital Roberto del Río, Santiago, Chile.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Chacón-Cruz', 'Affiliation': 'Servicio de Infectología, Hospital General de Tijuana, Tijuana, Mexico.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Saltigeral-Simental', 'Affiliation': 'Servicio de Infectología, Instituto Nacional de Pediatría y Hospital Infantil Privado, Ciudad de México, Mexico.'}, {'ForeName': 'Lucila', 'Initials': 'L', 'LastName': 'Martínez-Medina', 'Affiliation': 'Servicio de Infectología, Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Dueñas', 'Affiliation': 'Servicio de Infectología, Hospital de Niños Benjamín Bloom, San Salvador, El Salvador.'}, {'ForeName': 'Kathia', 'Initials': 'K', 'LastName': 'Luciani', 'Affiliation': 'Servicio de Infectología, Hospital de Especialidades Pediátricas Omar Torrijos Herrera, Caja de Seguro Social, Ciudad de Panamá, Panama.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Rodríguez-Quiroz', 'Affiliation': 'Servicio de Reumatología, Instituto Hondureño de Seguridad Social, Tegucigalpa, Honduras.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Camacho-Moreno', 'Affiliation': 'Servicio de Infectología, Fundación HOMI Hospital Pediátrico de la Misericordia & Universidad Nacional de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Viviani', 'Affiliation': 'Servicio de Infectología, Hospital Sotero del Río, Santiago, Chile.'}, {'ForeName': 'Martha I', 'Initials': 'MI', 'LastName': 'Alvarez-Olmos', 'Affiliation': 'Servicio de Infectología, Fundación Cardioinfantil & Universidad El Bosque, Bogotá, Colombia.'}, {'ForeName': 'Heloisa Helena de Sousa', 'Initials': 'HHS', 'LastName': 'Marques', 'Affiliation': 'Servicio de Infectología, Hospital Das Clinicas da Faculdade Medicina de la USP, São Paolo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Departamento de Pediatría, Universidad del Valle y Centro Médico Imbanaco, Cali, Colombia.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Pirez', 'Affiliation': 'Servicio de Infectología, Hospital Pediátrico Centro Hospitalario Pereira Rossell, Montevideo, Uruguay.'}, {'ForeName': 'Adriana H', 'Initials': 'AH', 'LastName': 'Tremoulet', 'Affiliation': 'University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Frontiers in pediatrics,['10.3389/fped.2020.00442']
1827,33194877,A Pilot Study of Two Different Constraint-Induced Movement Therapy Interventions in Children With Hemiplegic Cerebral Palsy After Botulinum Toxin Injection During Preschool Education.,"Introduction:  To establish a pilot study on applying two low dose (40 h) constraint-induced movement therapy (CIMT) interventions in children with hemiplegic cerebral palsy (CP) after botulinum toxin (BoNT-A) injection during preschool education.  Methods:  Five children with spastic CP (mean age: 5.31 years; Gross Motor Function Classification System level I and II) undergoing regular BoNT-A injections and rehabilitation programs were included. Participants were randomly allocated to one of two CIMT programs (40 h): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection. The outcomes were measured by changes in Goal Attainment Scaling (GAS), the grasp and Visual-Motor Integration (VMI) test in Peabody-Developmental Motor Scales (PDMS), the self-care scale on the Functional Skill Scale, and the Caregiver Assistance in Chinese Version of Pediatric Evaluation of Disability Inventory (PEDI-C), Anxiety and Oppositional Defiance Problems of Achenbach System of Empirically-Based Assessment before and after the CIMT interventions, and at every 2 months' follow-up thereafter.  Results:  The mean age of the participants was 5.31 years, BMI was 16.7 (kg/m 2 ), VIQ was 86.4 ± 8.5, and dose of BoNT-A injection in the upper limb was 42 ± 26.6 units. Grasp, VMI, and self-care on the Functional Skill Scale were significantly better in the 4-week 2-hours/day CIMT program ( p  < 0.001,  p  = 0.001,  p  < 0.001). GAS, grasp, VMI, two 2 self-care scales of PEDI were significantly improved after the CIMT programs, and improvement continued for up to 4 months after the programs. There was no clinical evidence showing changes in the scores for anxiety and oppositional defiance problems during the study period.  Conclusions:  The preliminary findings, although limited, suggest a potential therapeutic role for the school-based CIMT program after BoNT-A injection. The 4-week 2-hours/day CIMT program might be better than a 2-week 4-hours/day program in terms of self-care and hand function when performed in kindergarten in this pilot study. Furthermore, this pilot study provides valuable information; therefore, it is crucial to include more CP children and blinded assessors for hand function and ADL in the future study.",2020,"GAS, grasp, VMI, two 2 self-care scales of PEDI were significantly improved after the CIMT programs, and improvement continued for up to 4 months after the programs.","['children with hemiplegic cerebral palsy (CP) after', 'Children With Hemiplegic Cerebral Palsy', 'The mean age of the participants was 5.31 years, BMI was 16.7 (kg/m 2 ), VIQ was 86.4 ± 8.5, and dose of BoNT', 'Five children with spastic CP (mean age: 5.31 years; Gross Motor Function Classification System level I and II) undergoing regular BoNT-A injections and rehabilitation programs were included']","['low dose (40 h) constraint-induced movement therapy (CIMT) interventions', 'Two Different Constraint-Induced Movement Therapy Interventions', 'Botulinum Toxin Injection', 'botulinum toxin (BoNT-A) injection', 'CIMT program and a 4-week 2-hours/day CIMT program']","['GAS, grasp, VMI, two 2 self-care scales of PEDI', 'Grasp, VMI, and self-care on the Functional Skill Scale', 'Goal Attainment Scaling (GAS), the grasp and Visual-Motor Integration (VMI) test in Peabody-Developmental Motor Scales (PDMS), the self-care scale on the Functional Skill Scale, and the Caregiver Assistance in Chinese Version of Pediatric Evaluation of Disability Inventory (PEDI-C), Anxiety and Oppositional Defiance Problems of Achenbach System of Empirically-Based Assessment', 'anxiety and oppositional defiance problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",5.0,0.015956,"GAS, grasp, VMI, two 2 self-care scales of PEDI were significantly improved after the CIMT programs, and improvement continued for up to 4 months after the programs.","[{'ForeName': 'Chin-Lung', 'Initials': 'CL', 'LastName': 'Wu', 'Affiliation': 'Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, Changhua Christian Hospital, Changhua City, Taiwan.'}, {'ForeName': 'Su-Fen', 'Initials': 'SF', 'LastName': 'Liao', 'Affiliation': ""Division of Pediatric Rehabilitation, Changhua Christian Children's Hospital, Changhua City, Taiwan.""}, {'ForeName': 'Chi-Hsin', 'Initials': 'CH', 'LastName': 'Liu', 'Affiliation': 'Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, Changhua Christian Hospital, Changhua City, Taiwan.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Hsieh', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Lukang Christian Hospital, Changhua City, Taiwan.'}, {'ForeName': 'Yi-Ru', 'Initials': 'YR', 'LastName': 'Lin', 'Affiliation': 'Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, Changhua Christian Hospital, Changhua City, Taiwan.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00557']
1828,33194963,Cost-Effectiveness of Gliclazide-Based Intensive Glucose Control vs. Standard Glucose Control in Type 2 Diabetes Mellitus. An Economic Analysis of the ADVANCE Trial in Vietnam.,"Introduction:  ADVANCE was a large, multinational clinical study conducted over 5 years in type 2 diabetes mellitus (T2DM). In all, 11,140 patients were randomly assigned to receive gliclazide-based intensive glucose control (IGC) or standard glucose control (SGC). IGC was shown to significantly reduce the incidence of major macrovascular and microvascular events (composite endpoint) or major microvascular events compared with SGC, primarily by enhancing renal protection. We assessed the cost-effectiveness of IGC vs. SGC, based on the ADVANCE results, from a Vietnamese healthcare payer perspective.  Materials and Methods:  A partitioned survival times model across five health states (no complications, myocardial infarction, stroke, end-stage renal disease [ESRD], and diabetes-related eye-disease) was designed. Time-to-event curves were informed by the cumulative incidence of events and corresponding hazard ratios from the ADVANCE study. Health outcomes were expressed in terms of ESRD avoided and quality-adjusted life years (QALYs). Costs (in US $) comprised treatment costs and health state costs. Utility weights and costs were documented from literature reporting Vietnamese estimates. For sensitivity analyses, all parameters were individually varied within their 95% confidence interval bounds (when available) or within a ±30% range.  Results:  Over a 5-year horizon, IGC avoided 6.5 additional ESRD events per 1,000 patients treated compared with SGC (IGC, 3.5 events vs. SGC, 10.0 events) and provided 0.016 additional QALYs (IGC, 3.570 QALYs vs. SGC, 3.555 QALYs). Total costs were similar for the two strategies (IGC, $3,786 vs. SGC, $3,757). Although the total drug costs were markedly higher for IGC compared with SGC ($1,703 vs. $873), this was largely offset by the savings from better renal protection with IGC (IGC, $577 vs. SGC, $1,508). The incremental cost-effectiveness ratio (ICER) of IGC vs. SGC was $1,878/QALY gained, far below the threshold recommended by the World Health Organization (i.e., 1-3 × gross domestic product per inhabitant ≈$7,500 in Vietnam). The ICER of IGC vs. SGC per ESRD event avoided was $4,559/event. The findings were robust to sensitivity analysis.  Conclusion:  In Vietnam, gliclazide-based IGC was shown to be cost-effective compared with SGC from a healthcare payer perspective, as defined in the ADVANCE study.",2020,"IGC was shown to significantly reduce the incidence of major macrovascular and microvascular events (composite endpoint) or major microvascular events compared with SGC, primarily by enhancing renal protection.","['Type 2 Diabetes Mellitus', '11,140 patients', '5 years in type 2 diabetes mellitus (T2DM']","['IGC vs. SGC', 'SGC', 'Gliclazide-Based Intensive Glucose Control vs. Standard Glucose Control', 'IGC', 'gliclazide-based intensive glucose control (IGC) or standard glucose control (SGC', 'gliclazide-based IGC']","['total drug costs', 'incremental cost-effectiveness ratio (ICER', 'complications, myocardial infarction, stroke, end-stage renal disease [ESRD], and diabetes-related eye-disease', '5-year horizon', 'Cost-Effectiveness', 'ESRD avoided and quality-adjusted life years (QALYs', 'Utility weights and costs', 'Total costs', 'incidence of major macrovascular and microvascular events', 'treatment costs and health state costs']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}]",11140.0,0.0319247,"IGC was shown to significantly reduce the incidence of major macrovascular and microvascular events (composite endpoint) or major microvascular events compared with SGC, primarily by enhancing renal protection.","[{'ForeName': 'Hai-Yen', 'Initials': 'HY', 'LastName': 'Nguyen-Thi', 'Affiliation': 'Department of Pharmaceutical Administration, Faculty of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nga Tq', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pharmaceutical Administration, Faculty of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Dang Tu', 'Initials': 'NDT', 'LastName': 'Le', 'Affiliation': 'Department of Pharmaceutical Administration, Faculty of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Beillat', 'Affiliation': 'Servier Global Market Access & Health Economics and Outcomes Research, Suresnes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ethgen', 'Affiliation': 'SERFAN Innovation, Namur, Belgium.'}]",Frontiers in public health,['10.3389/fpubh.2020.562023']
1829,33194976,"Midwives' Experiences of Providing the ""Inspirational Lecture"" as a Care Intervention for Expectant Parents-A Qualitative Study.","Background:  In most Western countries, ordinary parental classes exist and have become a well-established form of professional support within midwifery care, even though some of these classes lack evidence of benefits for the parents. A Swedish randomized controlled trial including an intervention as a pilot study, revealed that a type of parental preparatory professional support provided for expectant parents, the ""inspirational lecture,"" showed a tendency to be beneficial for parents' birth experience, and their perceived quality of parental couple relationship. However, there is no previous research on the midwives' experiences from providing the inspirational lecture. Carrying out research on midwives' experiences from providing the lecture, could bring future opportunities to provide a work-integrated learning (WIL) related to professionals' skills, and the pedagogic used.  Aim:  To elucidate midwives' experiences about providing the inspirational lecture as a care intervention for expectant parents.  Methods:  Midwives were interviewed and data were analyzed using qualitative content analysis.  Results:  The midwives strived to put childbirth into a comprehensive and manageable context for the expectant parents, during the inspirational lecture. For this, different approaches were used to make expectant parents understand how the parents themselves can be engaged participants in their own birth.  Conclusion and Clinical Implications:  The midwives used the inspirational lecture to provide the expectant parents with knowledge about how they, as a parental couple, could cooperate and feel safe in relation to the upcoming birth. This could be understood as if the midwives were striving to facilitate the integrative power of the parental couple, which is the couples' ability to gather their joint power. These results can assist midwives and serve as a reference for providing parental classes for expectant parents with a focus on promoting both the parents' individual as well as mutual skills.",2020,"The midwives strived to put childbirth into a comprehensive and manageable context for the expectant parents, during the inspirational lecture.",[],[],[],[],[],[],,0.0254005,"The midwives strived to put childbirth into a comprehensive and manageable context for the expectant parents, during the inspirational lecture.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bäckström', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Söderlund', 'Affiliation': 'Skaraborg Hospital Skövde, ""Woman, Child"" (K3), Skövde, Sweden.'}, {'ForeName': 'Stina', 'Initials': 'S', 'LastName': 'Thorstensson', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Lena B', 'Initials': 'LB', 'LastName': 'Mårtensson', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Golsäter', 'Affiliation': 'Futurum, Academy for Health and Care, Jönköping, Sweden.'}]",Frontiers in public health,['10.3389/fpubh.2020.575062']
1830,33195176,Effect of Novel Remodeled Bicycle Pedal Training on Balance Performance in Athletes With Functional Ankle Instability.,"Context


Appropriate training without risk of injury is a critical concern for athletes. Remodeled bicycle pedal training with multi-directional challenges may be effective in improving the balance performance of athletes with functional ankle instability (FAI).
Objective


To evaluate the effects of 6-week modified bicycle pedal training on the balance ability and proprioception of athletes with FAI.
Design


Randomized controlled trial.
Setting


University motion analysis laboratory.
Participants


Fourteen healthy athletes (healthy group) and twenty-six athletes with FAI and an age of 18 to 30 years old. The participants with FAI were randomly distributed to two groups, designated as the training group (AI-T group) and non-training group (AI-NT group), respectively. The athletes in the AI-T group received 6-week remodeled bicycle pedal training, while those in the AI-NT group received no intervention at all.
Intervention


A 6-week training using modified bicycle pedal capable of moving freely during loading cycle vs no intervention.
Main Outcome Measures


The passive ankle joint position sense (JPS) in four angles and the center of pressure (COP) parameters were analyzed during single-leg standing with and without vision, respectively.
Results


A 6-week remodeled pedal training: (1) significantly improved the passive JPS of ankle in all directions ( P  < 0.05); (2) reduced the excursion of the COP in the medial-lateral (ML) direction ( p  < 0.05), the velocity of the COP in the ML direction ( p  < 0.05), and the RMS of the COP in the ML direction ( P  < 0.05) during single-leg standing both with and without vision.
Conclusion


The remodeled bicycle pedal training improved the passive JPS and reduced the postural sway in single-leg standing both with and without vision. Therefore, remodeled bicycle pedal training can be considered for inclusion in rehabilitation programs for athletes with FAI to restore the proprioception and balance ability.",2020,"(1) significantly improved the passive JPS of ankle in all directions ( P  < 0.05); (2) reduced the excursion of the COP in the medial-lateral (ML) direction ( p  < 0.05), the velocity of the COP in the ML direction ( p  < 0.05), and the RMS of the COP in the ML direction ( P  < 0.05) during single-leg standing both with and without vision.
","['athletes with FAI', 'Participants\n\n\nFourteen healthy athletes (healthy group) and twenty-six athletes with FAI and an age of 18 to 30 years old', 'athletes with functional ankle instability (FAI', 'participants with FAI', 'Athletes With Functional Ankle Instability']","['remodeled bicycle pedal training improved the passive JPS and reduced the postural sway in single-leg standing both with and without vision', '6-week remodeled bicycle pedal training, while those in the AI-NT group received no intervention at all', 'Novel Remodeled Bicycle Pedal Training', 'training group (AI-T group) and non-training', 'passive ankle joint position sense (JPS', 'remodeled pedal training', 'modified bicycle pedal training']","['RMS of the COP', 'velocity of the COP', 'Balance Performance', 'excursion of the COP in the medial-lateral (ML) direction', 'passive JPS of ankle']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0277851', 'cui_str': 'Ankle instability'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]",14.0,0.0212083,"(1) significantly improved the passive JPS of ankle in all directions ( P  < 0.05); (2) reduced the excursion of the COP in the medial-lateral (ML) direction ( p  < 0.05), the velocity of the COP in the ML direction ( p  < 0.05), and the RMS of the COP in the ML direction ( P  < 0.05) during single-leg standing both with and without vision.
","[{'ForeName': 'Yi-Shuo', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Md Samsul', 'Initials': 'MS', 'LastName': 'Arefin', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'You', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Li-Chieh', 'Initials': 'LC', 'LastName': 'Kuo', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Fong-Chin', 'Initials': 'FC', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hong-Wen', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Education, National Taiwan University of Sport, Taichung, Taiwan.'}, {'ForeName': 'Cheng-Feng', 'Initials': 'CF', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Frontiers in bioengineering and biotechnology,['10.3389/fbioe.2020.600187']
1831,33195188,Integrative Models of Histopathological Image Features and Omics Data Predict Survival in Head and Neck Squamous Cell Carcinoma.,"Background


Both histopathological image features and genomics data were associated with survival outcome of cancer patients. However, integrating features of histopathological images, genomics and other omics for improving prognosis prediction has not been reported in head and neck squamous cell carcinoma (HNSCC).
Methods


A dataset of 216 HNSCC patients was derived from the Cancer Genome Atlas (TCGA) with information of clinical characteristics, genetic mutation, RNA sequencing, protein expression and histopathological images. Patients were randomly assigned into training ( n  = 108) or validation ( n  = 108) sets. We extracted 593 quantitative image features, and used random forest algorithm with 10-fold cross-validation to build prognostic models for overall survival (OS) in training set, then compared the area under the time-dependent receiver operating characteristic curve (AUC) in validation set.
Results


In validation set, histopathological image features had significant predictive value for OS (5-year AUC = 0.784). The histopathology + omics models showed better predictive performance than genomics, transcriptomics or proteomics alone. Moreover, the multi-omics model incorporating image features, genomics, transcriptomics and proteomics reached the maximal 1-, 3-, and 5-year AUC of 0.871, 0.908, and 0.929, with most significant survival difference ( HR  = 10.66, 95%CI: 5.06-26.8,  p  < 0.001). Decision curve analysis also revealed a better net benefit of multi-omics model.
Conclusion


The histopathological images could provide complementary features to improve prognostic performance for HNSCC patients. The integrative model of histopathological image features and omics data might serve as an effective tool for survival prediction and risk stratification in clinical practice.",2020,"In validation set, histopathological image features had significant predictive value for OS (5-year AUC = 0.784).","['216 HNSCC patients was derived from the Cancer Genome Atlas (TCGA) with information of clinical characteristics, genetic mutation, RNA sequencing, protein expression and histopathological images', 'cancer patients', 'head and neck squamous cell carcinoma (HNSCC', 'Head and Neck Squamous Cell Carcinoma']",[],[],"[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],[],593.0,0.105236,"In validation set, histopathological image features had significant predictive value for OS (5-year AUC = 0.784).","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'State Key Laboratory of Biotherapy, Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University Collaborative Innovation Center, Chengdu, China.'}, {'ForeName': 'Linyan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Biotherapy, Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University Collaborative Innovation Center, Chengdu, China.'}, {'ForeName': 'Yeqian', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'State Key Laboratory of Biotherapy, Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University Collaborative Innovation Center, Chengdu, China.'}]",Frontiers in cell and developmental biology,['10.3389/fcell.2020.553099']
1832,33181674,Flipped classroom combined with human anatomy web-based learning system shows promising effects in anatomy education.,"Flipped classroom has received much attention in medical education. The aim of this study was to evaluate the efficacy of flipped classroom combing with human anatomy web-based learning system in anatomy education.A total of 89 freshmen in medical specialty were enrolled and randomly allocated into either the experimental group (receiving the flipped classroom with human anatomy web-based learning system, n = 45) or control group (receiving the traditional classroom teaching, n = 44). A pre-quiz and a post-quiz were conducted before and after the classes, respectively. The improvement in scores between groups was compared. A 5-point Likert scale questionnaire was used to evaluate perceptions and experience.The mean pre-quiz scores of the 2 groups were comparable (all P > .05). However, the mean post-quiz score in the experimental group was significantly higher than that in the control group (91.44 ± 6.25 vs 86.13 ± 11.67, P < .05). The results of questionnaires showed that 44 (97.8%) students agreed with flipped classroom combined with human anatomy web-based learning system, 43 (95.6%) students obtained improved study interest in anatomy learning, and 42 (93.3%) students felt that the interactive, applied in-class activities during the class greatly enhanced their learning.Flipped classroom combined with human anatomy web-based learning system can be used as an effective learning tool for anatomy education.",2020,The mean pre-quiz scores of the 2 groups were comparable (all P > .05).,['A total of 89 freshmen in medical specialty'],"['experimental group (receiving the flipped classroom with human anatomy web-based learning system, n\u200a=\u200a45) or control group (receiving the traditional classroom teaching, n\u200a=\u200a44', 'flipped classroom combing with human anatomy web-based learning system', 'Flipped classroom combined with human anatomy web-based learning system']","['mean post-quiz score', 'mean pre-quiz scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376161', 'cui_str': 'Comb'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",89.0,0.0179,The mean pre-quiz scores of the 2 groups were comparable (all P > .05).,"[{'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Health and Nursing School.'}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Health and Nursing School.'}, {'ForeName': 'Hanqi', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Nursing Class 1905, Wuxi Taihu University, Wuxi, Jiangsu.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.""}]",Medicine,['10.1097/MD.0000000000023096']
1833,33181675,"Smartphone education improves embarrassment, bowel preparation, and satisfaction with care in patients receiving colonoscopy: A randomized controlled trail.","BACKGROUND


Colonoscopy is considered a safe and effective tool for detecting colorectal cancer. Nevertheless, the proportion of patients are hesitating to receive colonoscopy. Smartphone education may decrease the barrier of colonoscopy. The aim of this study is to examine the effectiveness of smartphone education in colonoscopy.
METHODS


We conducted a prospective, double-blinded, randomized, controlled study to examine the effectiveness of smartphone education on embarrassment, bowel preparation, and satisfaction in colonoscopy. The patients' embarrassment was measured by the colonoscopy embarrassment scale. The quality of the bowel preparation was evaluated by gastroenterologists according to the Aronchik Scale. The satisfaction of colonoscopy care was assessed by a satisfaction scale developed by the authors.
RESULTS


A total of 150 patients were analyzed in the smartphone education and control groups (n = 75 in each group). The smartphone education group reported fewer embarrassment (B = -2.78, P = .02) than those of the control group, the patients who were older (B = .15, P = .001) and who were male (B = 2.91, P = .003) showed higher embarrassment. Additionally, smartphone education group were likely to have better colon preparation (odds ratio = 2.46, 95% confidence interval: 1.20-5.02) than that of the control group. Smartphone education also improved the satisfaction with care (β = 4.60, P < .001), and above normal body mass index decreased the satisfaction with care (β = -0.19, P < .05).
CONCLUSION


Smartphone education improves embarrassment, bowel preparation, and satisfaction with care in patients receiving colonoscopy.",2020,"Smartphone education also improved the satisfaction with care (β = 4.60, P < .001), and above normal body mass index decreased the satisfaction with care (β = -0.19, P < .05).
","['patients who were older', 'patients receiving colonoscopy', 'A total of 150 patients were analyzed in the smartphone education and control groups (n\u200a=\u200a75 in each group']","['Smartphone education', 'smartphone education']","['embarrassment (B\u200a', 'barrier of colonoscopy', 'embarrassment, bowel preparation, and satisfaction with care', 'satisfaction of colonoscopy care', 'better colon preparation', 'colonoscopy embarrassment scale', 'quality of the bowel preparation', 'higher embarrassment', 'embarrassment, bowel preparation, and satisfaction in colonoscopy', 'satisfaction with care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205250', 'cui_str': 'High'}]",150.0,0.0777539,"Smartphone education also improved the satisfaction with care (β = 4.60, P < .001), and above normal body mass index decreased the satisfaction with care (β = -0.19, P < .05).
","[{'ForeName': 'Ming-Chu', 'Initials': 'MC', 'LastName': 'Wen', 'Affiliation': 'Diagnostic and therapeutic center of endoscopy and ultrasonography, China Medical University Hospital, Taichung.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kau', 'Affiliation': 'Academic Writing Education Center, National Taiwan University, Taipei.'}, {'ForeName': 'Sheng-Shiung', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'College of Nursing and Health Sciences, Da-Yeh University, Changhua.'}, {'ForeName': 'Wen-Hsin', 'Initials': 'WH', 'LastName': 'Huang', 'Affiliation': 'Department of gastroenterology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Li-Yun', 'Initials': 'LY', 'LastName': 'Tsai', 'Affiliation': 'College of Nursing and Health Sciences, Da-Yeh University, Changhua.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of gastroenterology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Shiow-Luan', 'Initials': 'SL', 'LastName': 'Tsay', 'Affiliation': 'College of Nursing and Health Sciences, Da-Yeh University, Changhua.'}]",Medicine,['10.1097/MD.0000000000023102']
1834,33184328,"Efficacy of single-dose cholecalciferol in the blood pressure of patients with type 2 diabetes, hypertension and hypovitaminoses D.","Observational and experimental data reinforce the concept that vitamin D is associated with the pathogenesis of arterial hypertension. We investigated the effect of a single dose of 100,000 IU of cholecalciferol, in office blood pressure (BP), and 24-h ambulatory blood pressure monitoring (ABPM) in patients with type 2 diabetes mellitus (DM), hypertension, and hypovitaminosis D. Forty-three patients were randomized to a placebo or cholecalciferol group. BP was assessed by office measurements and 24-h ABPM, before and after intervention. At week 8, a greater decrease in median ABPM values was observed in cholecalciferol supplementation than in the placebo group for systolic 24-h (- 7.5 vs. - 1; P = 0.02), systolic daytime (- 7 vs. - 1; P = 0.007), systolic nighttime (- 7.0 vs. 3; P = 0.009), diastolic 24-h (- 3.5 vs. - 1; P = 0.037), and daytime DBP (- 5 vs. 0; P = 0.01). Office DBP was also reduced after vitamin D supplementation. A single dose of vitamin D 3  improves BP in patients with type 2 diabetes, hypertension, and vitamin D insufficiency, regardless of vitamin D normalization. Vitamin D supplementation could be a valuable tool to treat patients with type 2 DM, hypertension, and hypovitaminosis D.Trial registration: Clinicaltrials.gov NCT02204527.",2020,"At week 8, a greater decrease in median ABPM values was observed in cholecalciferol supplementation than in the placebo group for systolic 24-h (- 7.5 vs. - 1; P = 0.02), systolic daytime (- 7 vs. - 1; P = 0.007), systolic nighttime (- 7.0 vs. 3; P = 0.009), diastolic 24-h (- 3.5 vs. - 1; P = 0.037), and daytime DBP (","['patients with type 2 diabetes, hypertension, and vitamin D insufficiency, regardless of vitamin D normalization', 'patients with type 2 diabetes mellitus (DM), hypertension, and hypovitaminosis D. Forty-three patients', 'patients with type 2 diabetes, hypertension and hypovitaminoses D']","['single-dose cholecalciferol', '24-h ambulatory blood pressure monitoring (ABPM', 'vitamin D', 'placebo or cholecalciferol', 'cholecalciferol', 'placebo', 'Vitamin D supplementation']","['systolic nighttime', 'Office DBP', 'median ABPM values', 'blood pressure', 'systolic daytime', 'daytime DBP ', 'diastolic 24-h', 'BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376286', 'cui_str': 'Avitaminosis'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",43.0,0.380935,"At week 8, a greater decrease in median ABPM values was observed in cholecalciferol supplementation than in the placebo group for systolic 24-h (- 7.5 vs. - 1; P = 0.02), systolic daytime (- 7 vs. - 1; P = 0.007), systolic nighttime (- 7.0 vs. 3; P = 0.009), diastolic 24-h (- 3.5 vs. - 1; P = 0.037), and daytime DBP (","[{'ForeName': 'Tatiana P', 'Initials': 'TP', 'LastName': 'de Paula', 'Affiliation': 'Endocrine Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, Prédio 12, 4º andar, Porto Alegre, RS, 90035-003, Brazil. tatiana.ppaula@gmail.com.'}, {'ForeName': 'Juliano S R', 'Initials': 'JSR', 'LastName': 'Moreira', 'Affiliation': 'Endocrine Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, Prédio 12, 4º andar, Porto Alegre, RS, 90035-003, Brazil.'}, {'ForeName': 'Luiza F', 'Initials': 'LF', 'LastName': 'Sperb', 'Affiliation': 'Endocrine Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, Prédio 12, 4º andar, Porto Alegre, RS, 90035-003, Brazil.'}, {'ForeName': 'Maria Elisa P', 'Initials': 'MEP', 'LastName': 'Muller', 'Affiliation': 'Endocrine Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, Prédio 12, 4º andar, Porto Alegre, RS, 90035-003, Brazil.'}, {'ForeName': 'Thais', 'Initials': 'T', 'LastName': 'Steemburgo', 'Affiliation': 'Postgraduate Program in Food, Nutrition, and Health, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luciana V', 'Initials': 'LV', 'LastName': 'Viana', 'Affiliation': 'Endocrine Division, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Rua Ramiro Barcelos, 2350, Prédio 12, 4º andar, Porto Alegre, RS, 90035-003, Brazil.'}]",Scientific reports,['10.1038/s41598-020-76646-6']
1835,33184437,Oral probiotics to reduce vaginal group B streptococcal colonization in late pregnancy.,"This study aimed to evaluate the potential of oral probiotics to eradicate vaginal GBS colonization during the third trimester of pregnancy. We screened 1058 women for GBS colonization at 33-37 gestational weeks using a combination of vaginal-to-rectal swab and culture-based methods. Women who tested GBS positive were randomized to either the verum group, receiving a dietary probiotic supplement of four viable strains of Lactobacillus twice-daily for 14 days, or to the placebo group. Women underwent follow-up smears, whereat GBS colonization upon follow-up was considered the primary endpoint. We found that 215 women (20.3%) were positive for GBS upon screening, of which 82 (38.1%) were eligible for study inclusion; 41 (50%) of these were randomized to the verum and placebo groups each. After treatment, 21/33 (63.6%) members of the verum group, and 21/27 (77.8%) of the placebo group were still GBS positive (p = 0.24). Four (9.8%) women in the verum group and one (2.4%) in the placebo group experienced preterm birth (p = 0.20); smokers showed significantly higher rates of preterm birth (p = 0.03). Hence, the findings did not support the hypothesis that oral probiotics can eradicate GBS during pregnancy, although we observed a trend toward reduced GBS persistence after probiotic intake.",2020,"After treatment, 21/33 (63.6%) members of the verum group, and 21/27 (77.8%) of the placebo group were still GBS positive (p = 0.24).","['late pregnancy', 'Women who tested GBS positive', '215 women (20.3%) were positive for GBS upon screening, of which 82 (38.1%) were eligible for study inclusion; 41 (50', '1058 women for GBS colonization at 33-37 gestational weeks using a combination of vaginal-to-rectal swab and culture-based methods']","['dietary probiotic supplement', 'Oral probiotics', 'oral probiotics', 'placebo']","['still GBS positive', 'rates of preterm birth', 'preterm birth', 'GBS persistence']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0444215', 'cui_str': 'Rectal swab'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018378', 'cui_str': 'Guillain-Barré syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]",1058.0,0.273066,"After treatment, 21/33 (63.6%) members of the verum group, and 21/27 (77.8%) of the placebo group were still GBS positive (p = 0.24).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Farr', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. alex.farr@meduniwien.ac.at.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Sustr', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Kiss', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Rosicky', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Graf', 'Affiliation': 'Center for Medical Statistics, Informatics and Intelligent Systems (IMS), Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Makristathis', 'Affiliation': 'Department of Laboratory Medicine, Division of Clinical Microbiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Foessleitner', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Ljubomir', 'Initials': 'L', 'LastName': 'Petricevic', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}]",Scientific reports,['10.1038/s41598-020-76896-4']
1836,33185372,The Effect of Percutaneous Nucleoplasty vs Anterior Discectomy in Patients with Cervical Radicular Pain due to a Single-Level Contained Soft-Disc Herniation: A Randomized Controlled Trial.,"BACKGROUND


Cervical radicular pain (CRP) is a common problem in the adult population. When conservative treatment fails and the severe pain persist, surgical treatment is considered. However, surgery is associated with some serious risks. To reduce these risks, new minimally invasive techniques have been developed, such as percutaneous nucleoplasty. Several studies have shown that percutaneous nucleoplasty is a safe and effective technique for the treatment of CRP, but until now no randomized controlled trials have been conducted that compare percutaneous cervical nucleoplasty (PCN) to anterior cervical discectomy (ACD) in patients with a single-level contained soft-disc herniation.
OBJECTIVES


To compare the effects of PCN and ACD in a group of patients with CRP caused by a single-level contained soft-disc herniation.
STUDY DESIGN


A randomized, controlled, multi-center trial.
SETTING


Medical University Center and local hospitals.
METHODS


Forty-eight patients with CRP as a result of a single-level contained soft-disc herniation were randomized to one of the following 2 treatments: PCN or ACD. The primary outcome measure was arm pain intensity, measured with a Visual Analog Scale (VAS). Secondary outcomes were arm pain intensity during heavy effort, neck pain, global perceived effect, Neck Disability Index (NDI), and the patients' general health (Short Form Generated Health Survey [SF-36]). All parameters were measured at baseline (T0), 3 months after intervention (T2), and one year after intervention (T3). One week after the intervention (T1), an intermediate assessment of arm pain, arm pain during heavy effort, neck pain, satisfaction, and improvement were performed.
RESULTS


At 3 months, the intention to treat analyses revealed a statistical significant interaction between the groups on the primary outcome, arm pain intensity, and on the secondary outcome of the SF-36 item pain, in favor of the ACD group. On the other secondary outcomes, no statistical significant differences were found between the groups over time. At 12 months, there was a trend for more improvement of arm pain in favor of the ACD group and no statistical interactions were found on the secondary outcomes.
LIMITATIONS


Firstly, the inclusion by the participating hospitals was limited. Secondly, the trial was ended before reaching the required sample size. Thirdly, at baseline, after the inclusion by the neurosurgeon, 13 patients scored less than 50.0 mm on the VAS. Fourthly, the withdrawal of the physiotherapy (PT) group and finally, the patients and interventionists could not be blinded for the treatment.
CONCLUSIONS


At 3 months, the ACD group performed significantly better on arm pain reduction than the PCN group in patients with CRP as a result of a single-level contained soft-disc hernia. However, the clinical relevancy of this treatment effect can be debated. For all parameters, after one year, no significant differences between the groups were found. When it comes to the longer-term effectiveness, we conclude that PCN can be a good alternative for ACD.",2020,"At 12 months, there was a trend for more improvement of arm pain in favor of the ACD group and no statistical interactions were found on the secondary outcomes.
","['patients with CRP caused by a single-level contained soft-disc herniation', 'patients with a single-level contained soft-disc herniation', 'Forty-eight patients with CRP as a result of a single-level contained soft-disc herniation', 'Medical University Center and local hospitals', 'Patients with Cervical Radicular Pain due to a Single-Level Contained Soft-Disc Herniation']","['PCN', 'Percutaneous Nucleoplasty vs Anterior Discectomy', 'percutaneous cervical nucleoplasty (PCN) to anterior cervical discectomy (ACD', 'PCN and ACD', 'PCN or ACD']","[""pain intensity during heavy effort, neck pain, global perceived effect, Neck Disability Index (NDI), and the patients' general health (Short Form Generated Health Survey [SF-36"", 'pain intensity', 'arm pain', 'arm pain intensity, measured with a Visual Analog Scale (VAS', 'pain reduction', 'SF-36 item pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",48.0,0.136914,"At 12 months, there was a trend for more improvement of arm pain in favor of the ACD group and no statistical interactions were found on the secondary outcomes.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'de Rooij', 'Affiliation': 'Department of Anaesthesiology, Center for Pain Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands; Department of Orthopaedics, Physiotherapy Unit, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Biswadjiet', 'Initials': 'B', 'LastName': 'Harhangi', 'Affiliation': 'Department of Neurosurgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Aukes', 'Affiliation': 'Department of Anaesthesiology, Unit of Pain Medicine, Albert Schweitzer Hospital, Sliedrecht, The Netherlands.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Groeneweg', 'Affiliation': 'Department of Anaesthesiology, Center for Pain Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Stronks', 'Affiliation': 'Department of Anaesthesiology, Center for Pain Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Huygen', 'Affiliation': 'Department of Anaesthesiology, Center for Pain Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}]",Pain physician,[]
1837,33185373,Effect of Repeated Paravertebral Injections with Local Anesthetics and Steroids on Prevention of Post-herpetic Neuralgia.,"BACKGROUND


The usefulness of early sympathetic blockade in the prevention of postherpetic neuralgia (PHN) has been reported. However, the optimal duration and frequency of paravertebral blocks that prevent or maximally reduce the incidence of PHN need to be clarified.
OBJECTIVES


To assess the impact of weekly separated 2 versus 3 paravertebral injections using local anesthetic and steroids, early in the course of acute thoracic herpes zoster, on the incidence of postherpetic neuralgia.
STUDY DESIGN


Randomized single-blind study.
SETTING


University hospitals.
METHODS


Eighty patients suffering from acute thoracic herpes zoster eruption were randomly allocated into 2 groups. Group I received paravertebral block using 25 mg bupivacaine plus 8 mg dexamethasone in a total volume of 10 mL twice one week apart. Group II received paravertebral block using 25 mg bupivacaine plus 8 mg dexamethasone in a total volume of 10 mL 3 times one week apart. All patients received daily 300 mg pregabalin in divided doses (150 mg/12 hours). Pain scores were evaluated during each visit. Once the patient reported mild pain, the trial for reducing the pregabalin dose was done. Acetaminophen was available as a rescue analgesia. At each assessment visit, the total analgesic consumption was recorded. The times of the complete resolution of the pain and the skin eruption were recorded. The incidence of PHN after 3, 6, and 12 months was also reported.
RESULTS


Pre-eruptive pain severity and duration were comparable between both groups. There was no statistically significant difference between both groups with respect to the day of the block, the total duration of pain until the first block, and eruptive and herpetic pain duration parameters. The severity of skin lesions was comparable among both groups. Four patients (10.5%) had PHN in group I versus 3 patients (8.1%) in group II after 3 months of follow-up. Meanwhile, these numbers were 3 patients (7.9%) and 2 patients (5.4%) at 6 and 12 months in both groups, respectively. Compared with basal parameters, effective pain control was noticed in both groups with no significant difference between groups.
LIMITATIONS


Small size, lack of complete blindness, and the use of fluoroscopy in block performance in the era of performing this block under ultrasound.
CONCLUSIONS


Repeated paravertebral blocks using local anesthetic and steroids weekly over 2 or 3 weeks in the management of acute thoracic herpes zoster can provide safe and effective pain relief and minimize the incidence of PHN. However, no added benefit was detected from repeated blocks more than twice.",2020,"There was no statistically significant difference between both groups with respect to the day of the block, the total duration of pain until the first block, and eruptive and herpetic pain duration parameters.","['Eighty patients suffering from acute thoracic herpes zoster eruption', 'postherpetic neuralgia (PHN', 'University hospitals']","['Acetaminophen', 'Repeated Paravertebral Injections with Local Anesthetics and Steroids', 'bupivacaine plus 8 mg dexamethasone', 'pregabalin', 'paravertebral block']","['mild pain', 'severity of skin lesions', 'Pain scores', 'Prevention of Post-herpetic Neuralgia', 'total duration of pain until the first block, and eruptive and herpetic pain duration parameters', 'effective pain control', 'total analgesic consumption', 'times of the complete resolution of the pain and the skin eruption', 'incidence of PHN']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",80.0,0.0598153,"There was no statistically significant difference between both groups with respect to the day of the block, the total duration of pain until the first block, and eruptive and herpetic pain duration parameters.","[{'ForeName': 'Mohamed Younis', 'Initials': 'MY', 'LastName': 'Makharita', 'Affiliation': 'Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Amr', 'Affiliation': 'Departments of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University, Egypt.'}]",Pain physician,[]
1838,33185374,The Effect of Different Posture on Normal Saline Injection in Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia.,"BACKGROUND


Thoracolumbar or caudal epidural anesthesia affects intracranial pressure (ICP) in both animals and humans. Epidural injection increases ICP at least transiently. Measurement of the optic nerve sheath diameter (ONSD) using ultrasonography is one of the noninvasive methods for ICP assessment.
OBJECTIVES


The purpose of this study was to investigate the effect of the different posture during epidural saline injection to the ONSD under awake conditions.
STUDY DESIGN


Prospective, randomized trial.
SETTING


An interventional pain management practice in South Korea.
METHODS


This study included 44 patients receiving thoracic epidural catheterization for pain management after upper abdominal or thoracic surgery. Following successful epidural space confirmation, patients were randomized to receive epidural saline while supine (A group) or in sitting position (B group), respectively. Transorbital sonography was performed for the measurement of the ONSD, and the ONSD was measured at 3 mm posterior to the optic nerve head.
RESULTS


Both A and B groups showed significant increases of ONSD according to time. Mean ONSD values measured at T10, T20, and T40 significantly increased from the baseline value (T0) (*P < 0.05 vs. T0, †P < 0.001 vs. T0, ‡P < 0.005 vs. T0). The mean ONSD values measured at any of the time points and degrees of changes (T10-T0, T20-T0, and T40-T0) between groups A and B did not show any significant changes.
LIMITATIONS


Epidural pressure and ONSD measurement can make this study more reliable. Further study showing changes of epidural pressure with ONSD measurement is required.
CONCLUSIONS


Thoracic epidural injection of 10 mL of normal saline resulted in a significant increase of ONSD compared with the baseline. However, the different posture did not affect the increase of ONSD.",2020,"Mean ONSD values measured at T10, T20, and T40 significantly increased from the baseline value (T0) (*P < 0.05 vs. T0, †P < 0.001 vs. T0, ‡P < 0.005 vs. T0).","['An interventional pain management practice in South Korea', '44 patients receiving', 'for pain management after upper abdominal or thoracic surgery', 'Optic Nerve Sheath Diameter in Thoracic Epidural Anesthesia']","['Epidural injection', 'Thoracolumbar or caudal epidural anesthesia', 'Different Posture on Normal Saline Injection', 'thoracic epidural catheterization', 'epidural saline while supine (A group) or in sitting position', 'Thoracic epidural injection of 10 mL of normal saline']","['ICP', 'intracranial pressure (ICP', 'ONSD', 'Epidural pressure and ONSD measurement', 'mean ONSD values', 'Mean ONSD values']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2236549', 'cui_str': 'Implantation of thoracic epidural catheter'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",44.0,0.13828,"Mean ONSD values measured at T10, T20, and T40 significantly increased from the baseline value (T0) (*P < 0.05 vs. T0, †P < 0.001 vs. T0, ‡P < 0.005 vs. T0).","[{'ForeName': 'JiHoon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Keimyung University DongSan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'JiHee', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University School of Medicine, Republic of Korea.'}, {'ForeName': 'Jiseob', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University School of Medicine, Republic of Korea.'}, {'ForeName': 'SeungWon', 'Initials': 'S', 'LastName': 'Yi', 'Affiliation': 'Keimyung University DongSan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}]",Pain physician,[]
1839,33185375,A Comparison of the Effectiveness of Ultrasound-Guided Versus Landmark-Guided Suprascapular Nerve Block in Chronic Shoulder Pain: A Prospective Randomized Study.,"BACKGROUND


Suprascapular nerve block (SSNB) is an effective therapeutic approach for shoulder pain and has been increasingly used by professionals in clinical practice. In the landmark-guided nerve block technique, it could be difficult to determine the exact localization of the suprascapular nerve.
OBJECTIVES


To evaluate and compare the clinical and functional outcomes of ultrasound (US)-guided versus landmark-guided SSNB for the treatment of chronic shoulder pain.
STUDY DESIGN


Randomized, prospective analysis.
SETTING


Outpatient physical therapy and rehabilitation clinic.
METHODS


Seventy-two patients with chronic shoulder pain were enrolled into this study. The patients were randomly allocated to 2 groups. Thirty-six patients received US-guided SSNB and 36 underwent landmark-guided SSNB. Initial examinations before injection and for the first week and first and third months postinjection were recorded. Visual Analog Scale (VAS) pain intensity levels, shoulder functions based on the Shoulder Pain and Disability Index (SPADI), and quality of life levels based on the Health Assessment Questionnaire (HAQ) were evaluated at each control.
RESULTS


Statistically significant recovery was observed in terms of VAS pain levels, SPADI, and HAQ from the first week after injection in both groups, but no significant difference was observed between the groups.
LIMITATIONS


The absence of a control group.
CONCLUSIONS


Our results indicate that US-guided SSNB does not potentially offer a significantly greater clinical improvement over landmark-guided SSNB in patients with chronic shoulder pain. Further research is required to establish whether this hypothesis is consistently supported in practice.",2020,"Statistically significant recovery was observed in terms of VAS pain levels, SPADI, and HAQ from the first week after injection in both groups, but no significant difference was observed between the groups.
","['Seventy-two patients with chronic shoulder pain', 'Outpatient physical therapy and rehabilitation clinic', 'chronic shoulder pain', 'Chronic Shoulder Pain', 'patients with chronic shoulder pain']","['ultrasound (US)-guided versus landmark-guided SSNB', 'Suprascapular nerve block (SSNB', 'US-guided SSNB and 36 underwent landmark-guided SSNB', 'Ultrasound-Guided Versus Landmark-Guided Suprascapular Nerve Block']","['VAS pain levels, SPADI, and HAQ', 'Visual Analog Scale (VAS) pain intensity levels, shoulder functions based on the Shoulder Pain and Disability Index (SPADI), and quality of life levels based on the Health Assessment Questionnaire (HAQ']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",72.0,0.0372259,"Statistically significant recovery was observed in terms of VAS pain levels, SPADI, and HAQ from the first week after injection in both groups, but no significant difference was observed between the groups.
","[{'ForeName': 'Gonca', 'Initials': 'G', 'LastName': 'Saglam', 'Affiliation': 'Erzurum Regional Training and Research Hospital, Turkey.'}, {'ForeName': 'Dilek Çetinkaya', 'Initials': 'DÇ', 'LastName': 'Alisar', 'Affiliation': 'Erzurum Regional Training and Research Hospital, Turkey.'}]",Pain physician,[]
1840,33185650,Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial.,"Importance


The period following heart failure hospitalization (HFH) is a vulnerable time with high rates of death or recurrent HFH.
Objective


To evaluate clinical characteristics, outcomes, and treatment response to vericiguat according to prespecified index event subgroups and time from index HFH in the Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial.
Design, Setting, and Participants


Analysis of an international, randomized, placebo-controlled trial. All VICTORIA patients had recent (<6 months) worsening HF (ejection fraction <45%). Index event subgroups were less than 3 months after HFH (n = 3378), 3 to 6 months after HFH (n = 871), and those requiring outpatient intravenous diuretic therapy only for worsening HF (without HFH) in the previous 3 months (n = 801). Data were analyzed between May 2, 2020, and May 9, 2020.
Intervention


Vericiguat titrated to 10 mg daily vs placebo.
Main Outcomes and Measures


The primary outcome was time to a composite of HFH or cardiovascular death; secondary outcomes were time to HFH, cardiovascular death, a composite of all-cause mortality or HFH, all-cause death, and total HFH.
Results


Among 5050 patients in the VICTORIA trial, mean age was 67 years, 24% were women, 64% were White, 22% were Asian, and 5% were Black. Baseline characteristics were balanced between treatment arms within each subgroup. Over a median follow-up of 10.8 months, the primary event rates were 40.9, 29.6, and 23.4 events per 100 patient-years in the HFH at less than 3 months, HFH 3 to 6 months, and outpatient worsening subgroups, respectively. Compared with the outpatient worsening subgroup, the multivariable-adjusted relative risk of the primary outcome was higher in HFH less than 3 months (adjusted hazard ratio, 1.48; 95% CI, 1.27-1.73), with a time-dependent gradient of risk demonstrating that patients closest to their index HFH had the highest risk. Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity. Similar results were evident for all-cause death and HFH. Addtionally, a continuous association between time from HFH and vericiguat treatment showed a trend toward greater benefit with longer duration since HFH. Safety events (symptomatic hypotension and syncope) were infrequent in all subgroups, with no difference between treatment arms.
Conclusions and Relevance


Among patients with worsening chronic HF, those in closest proximity to their index HFH had the highest risk of cardiovascular death or HFH, irrespective of age or clinical risk factors. The benefit of vericiguat did not differ significantly across the spectrum of risk in worsening HF.
Trial Registration


ClinicalTrials.gov Identifier: NCT02861534.",2020,"Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity.","['Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) trial', '5050 patients in the VICTORIA trial, mean age was 67 years, 24% were women, 64% were White, 22% were Asian, and 5% were Black', 'patients with worsening chronic HF']","['placebo', 'HFH']","['time to a composite of HFH or cardiovascular death; secondary outcomes were time to HFH, cardiovascular death, a composite of all-cause mortality or HFH, all-cause death, and total HFH', 'Safety events (symptomatic hypotension and syncope']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}]",5050.0,0.243489,"Vericiguat was associated with reduced risk of the primary outcome overall and in all subgroups, without evidence of treatment heterogeneity.","[{'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giczewska', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Refsgaard', 'Affiliation': 'Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Edimar', 'Initials': 'E', 'LastName': 'Bocchi', 'Affiliation': 'Heart Institute (InCor), São Paulo University Medical School, São Paulo, Brazil.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'Merck and Co Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Charité University Medicine, German Heart Center, Berlin, Germany.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.6455']
1841,33185670,"Association of Baseline Low-Density Lipoprotein Cholesterol and Percentage Low-Density Lipoprotein Cholesterol Reduction With Statins, Ezetimibe, and PCSK9 Inhibition.","Importance


Low-density lipoprotein cholesterol (LDL-C) is an important modifiable risk factor for atherosclerotic cardiovascular disease. It is unclear whether the percentage LDL-C lowering with pharmacotherapies differs on the basis of baseline LDL-C levels.
Objective


To evaluate the association between baseline LDL-C levels and the percentage LDL-C reduction with a statin, ezetimibe, and a PCSK9 inhibitor.
Design, Setting, and Participants


This secondary exploratory study analyzed data from 3 randomized placebo-controlled clinical trials (Aggrastat to Zocor-Thrombolysis in Myocardial Infarction 21 [A to Z-TIMI 21], Improved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT], and Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk [FOURIER]) of lipid-lowering therapies (statin, ezetimibe, and a PCSK9 inhibitor) and included participants with atherosclerotic cardiovascular disease. Analyses took place form April to October 2020.
Interventions


In A to Z-TIMI 21, 1:1 randomization to simvastatin, 40 mg, daily for 30 days followed by 80 mg daily thereafter vs placebo for 4 months followed by simvastatin, 20 mg, daily thereafter. In IMPROVE-IT, 1:1 randomization to ezetimibe, 10 mg, daily plus simvastatin, 40 mg, daily vs placebo plus simvastatin, 40 mg, daily. In FOURIER, 1:1 randomization to evolocumab, 140 mg, every 2 weeks or 420 mg monthly vs matching placebo.
Main Outcomes and Measures


The percentage LDL-C reduction at either 1 month (A to Z-TIMI 21, IMPROVE-IT) or 3 months (FOURIER) as a function of baseline LDL-C level. Data were modeled using a generalized linear regression model.
Results


A total of 3187 patients from A to Z-TIMI 21, 10 680 patients from IMPROVE-IT, and 25 847 patients from FOURIER were analyzed. There was a higher percentage reduction in LDL-C levels with evolocumab in patients with lower baseline LDL-C levels, ranging from 59.4% (95% CI, 59.1%-59.8%) in patients with a baseline LDL-C level of 130 mg/dL to 66.1% (95% CI, 65.6%-66.6%) in patients with a baseline LDL-C level of 70 mg/dL (P < .001). In contrast, across the same range of baseline LDL-C level, there was a more modest difference for simvastatin (44.6% [95% CI, 43.9%-45.2%] vs 47.8% [95% CI, 46.4%-49.2%]; P < .001) and minimal difference with ezetimibe (25.0% [95% CI, 23.3%-26.6%] vs 26.2% [95% CI, 24.2%-28.1%]; P = .007).
Conclusions and Relevance


The percentage LDL-C reduction with statins, ezetimibe, and PCSK9 inhibition is not attenuated in patients starting with lower baseline LDL-C levels and is 6.6% greater for PCSK9 inhibition. These data are encouraging for the use of intensive LDL-C-lowering therapy even for patients with lower LDL-C levels.",2020,"There was a higher percentage reduction in LDL-C levels with evolocumab in patients with lower baseline LDL-C levels, ranging from 59.4% (95% CI, 59.1%-59.8%) in patients with a baseline LDL-C level of 130 mg/dL to 66.1% (95% CI, 65.6%-66.6%) in patients with a baseline LDL-C level of 70 mg/dL (P < .001).","['participants with atherosclerotic cardiovascular disease', 'Subjects With Elevated Risk', 'in Myocardial Infarction 21', '3187 patients from A to Z-TIMI 21, 10\u202f680 patients from IMPROVE-IT, and 25\u202f847 patients from FOURIER were analyzed']","['lipid-lowering therapies (statin, ezetimibe, and a PCSK9 inhibitor', 'Importance\n\n\nLow-density lipoprotein cholesterol (LDL-C', 'statin, ezetimibe, and a PCSK9 inhibitor', 'ezetimibe', 'placebo', 'placebo-controlled clinical trials (Aggrastat to Zocor-Thrombolysis', 'simvastatin', 'placebo\u2009plus\u2009simvastatin']","['LDL-C levels', 'Baseline Low-Density Lipoprotein Cholesterol and Percentage Low-Density Lipoprotein Cholesterol Reduction With Statins, Ezetimibe, and PCSK9 Inhibition', 'percentage LDL-C reduction', 'percentage LDL-C reduction with statins, ezetimibe, and PCSK9 inhibition']","[{'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C4521460', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0656369', 'cui_str': 'Aggrastat'}, {'cui': 'C0678181', 'cui_str': 'Zocor'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",3187.0,0.394483,"There was a higher percentage reduction in LDL-C levels with evolocumab in patients with lower baseline LDL-C levels, ranging from 59.4% (95% CI, 59.1%-59.8%) in patients with a baseline LDL-C level of 130 mg/dL to 66.1% (95% CI, 65.6%-66.6%) in patients with a baseline LDL-C level of 70 mg/dL (P < .001).","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Marcusa', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'de Lemos', 'Affiliation': 'Cardiology Division, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.6184']
1842,33180798,Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial.,"BACKGROUND


Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders' wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers.
METHODS


We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind's group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions.
RESULTS


A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure.
CONCLUSIONS


The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health.
TRIAL REGISTRATION


ISRCTN registry, ISRCTN79407277.",2020,"Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure.
","['emergency workers', 'emergency responders in England', '430 participants (resilience intervention N = 317; psychoeducation N = 113']","['tertiary service resilience intervention', 'group-based resilience intervention versus psychoeducation', 'online psychoeducation']","['psychological outcomes', 'self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C1510639', 'cui_str': 'Social Capital'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0559457', 'cui_str': 'Number of days off work'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",430.0,0.185348,"Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wild', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'El-Salahi', 'Affiliation': 'The Oxford Institute of Clinical Psychology Training and Research, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Degli Esposti', 'Affiliation': 'Department of Social Policy and Intervention, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Thew', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0241704']
1843,33180816,"High-dose naloxone: Effects by late administration on pain and hyperalgesia following a human heat injury model. A randomized, double-blind, placebo-controlled, crossover trial with an enriched enrollment design.","Severe chronic postsurgical pain has a prevalence of 4-10% in the surgical population. The underlying nociceptive mechanisms have not been well characterized. Following the late resolution phase of an inflammatory injury, high-dose μ-opioid-receptor inverse agonists reinstate hypersensitivity to nociceptive stimuli. This unmasking of latent pain sensitization has been a consistent finding in rodents while only observed in a limited number of human volunteers. Latent sensitization could be a potential triggering venue in chronic postsurgical pain. The objective of the present trial was in detail to examine the association between injury-induced secondary hyperalgesia and naloxone-induced unmasking of latent sensitization. Healthy volunteers (n = 80) received a cutaneous heat injury (47°C, 420 s, 12.5 cm2). Baseline secondary hyperalgesia areas were assessed 1 h post-injury. Utilizing an enriched enrollment design, subjects with a magnitude of secondary hyperalgesia areas in the upper quartile ('high-sensitizers' [n = 20]) and the lower quartile ('low-sensitizers' [n = 20]) were selected for further study. In four consecutive experimental sessions (Sessions 1 to 4), the subjects at two sessions (Sessions 1 and 3) received a cutaneous heat injury followed 168 h later (Sessions 2 and 4) by a three-step target-controlled intravenous infusion of naloxone (3.25 mg/kg), or normal saline. Assessments of secondary hyperalgesia areas were made immediately before and stepwise during the infusions. Simple univariate statistics revealed no significant differences in secondary hyperalgesia areas between naloxone and placebo treatments (P = 0.215), or between 'high-sensitizers' and 'low-sensitizers' (P = 0.757). In a mixed-effects model, secondary hyperalgesia areas were significantly larger following naloxone as compared to placebo for 'high-sensitizers' (P < 0.001), but not 'low-sensitizers' (P = 0.651). Although we could not unequivocally demonstrate naloxone-induced reinstatement of heat injury-induced hyperalgesia, further studies in clinical postsurgical pain models are warranted.",2020,"Simple univariate statistics revealed no significant differences in secondary hyperalgesia areas between naloxone and placebo treatments (P = 0.215), or between 'high-sensitizers' and 'low-sensitizers' (P = 0.757).","['Healthy volunteers (n = 80', ""subjects with a magnitude of secondary hyperalgesia areas in the upper quartile ('high-sensitizers' [n = 20]) and the lower quartile ('low-sensitizers' [n = 20]) were selected for further study""]","['naloxone', 'cutaneous heat injury followed 168 h later (Sessions 2 and 4) by a three-step target-controlled intravenous infusion of naloxone', 'cutaneous heat injury', 'placebo', 'normal saline']","['Baseline secondary hyperalgesia areas', 'Severe chronic postsurgical pain', 'secondary hyperalgesia areas', 'pain and hyperalgesia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0751212', 'cui_str': 'Hyperalgesia, Secondary'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0332685', 'cui_str': 'Thermal injury'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751212', 'cui_str': 'Hyperalgesia, Secondary'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}]",,0.203884,"Simple univariate statistics revealed no significant differences in secondary hyperalgesia areas between naloxone and placebo treatments (P = 0.215), or between 'high-sensitizers' and 'low-sensitizers' (P = 0.757).","[{'ForeName': 'Anders Deichmann', 'Initials': 'AD', 'LastName': 'Springborg', 'Affiliation': 'Neuroscience Center, Copenhagen University Hospitals, Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth Kjær', 'Initials': 'EK', 'LastName': 'Jensen', 'Affiliation': 'Neuroscience Center, Copenhagen University Hospitals, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Kreilgaard', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten Aagaard', 'Initials': 'MA', 'LastName': 'Petersen', 'Affiliation': 'The Research Unit, Department of Palliative Medicine, Copenhagen University Hospitals, Copenhagen, Denmark.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Papathanasiou', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Trine Meldgaard', 'Initials': 'TM', 'LastName': 'Lund', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bradley Kenneth', 'Initials': 'BK', 'LastName': 'Taylor', 'Affiliation': 'Department of Anesthesiology, Pittsburgh Center for Pain Research, and the Pittsburgh Project to End Opioid Misuse, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.'}, {'ForeName': 'Mads Utke', 'Initials': 'MU', 'LastName': 'Werner', 'Affiliation': 'Neuroscience Center, Copenhagen University Hospitals, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0242169']
1844,33180856,Effect of a decision aid on the choice of pregnant women whether to have epidural anesthesia or not during labor.,"OBJECTIVE


Decision aids (DAs) are useful in providing information for decision-making on using epidural anesthesia during birth. To date, there has been little development of DAs for Japanese pregnant women. Herein, we investigated the effect of a DA on the decision of pregnant women whether to have epidural anesthesia or not for labor during vaginal delivery. The primary outcome was changes in mean decision conflict score.
METHODS


In this non-randomized controlled trial, 300 low-risk pregnant women in an urban hospital were recruited by purposive sampling and assigned to 2 groups: DA (intervention) and pamphlet (control) groups. Control enrollment was started first (until 150 women), followed by intervention enrollment (150 women). Pre-test and post-test scores were evaluated using the Decision Conflict Scale (DCS) for primary outcome, knowledge of epidural anesthesia and satisfaction with decision making for secondary outcomes, and decision of anesthesia usage (i.e., with epidural anesthesia, without epidural anesthesia, or undecided).
RESULTS


Women in the DA group (n = 149: 1 excluded because she did not return post-test questionnaire) had significantly lower DCS score than those in the pamphlet group (n = 150) (DA: -8.41 [SD 8.79] vs. pamphlet: -1.69 [SD 5.91], p < .001). Knowledge of epidural anesthesia and satisfaction with decision-making scores of women who used the DA were significantly higher than those of women who used the pamphlet (p < .001). Women in the DA group showed a significantly lower undecided rate than those in the pamphlet group. The number of undecided women in the DA group significantly decreased from 30.2% to 6.1% (p < .001), whereas that in the pamphlet group remained largely unchanged from 40.7% to 38.9%.
CONCLUSION


This study indicates that a DA can be useful in helping women make a decision whether to have epidural anesthesia or not for labor during vaginal delivery.",2020,Knowledge of epidural anesthesia and satisfaction with decision-making scores of women who used the DA were significantly higher than those of women who used the pamphlet (p < .001).,"['DA', 'Japanese pregnant women', 'pregnant women whether to have epidural anesthesia or not for labor during vaginal delivery', 'pregnant women whether to have epidural anesthesia or not during labor', 'Women in the DA group (n = 149', '300 low-risk pregnant women in an urban hospital were recruited by purposive sampling and assigned to 2 groups: DA (intervention) and pamphlet (control) groups']",['DA'],"['mean decision conflict score', 'Knowledge of epidural anesthesia and satisfaction with decision-making scores', 'Decision Conflict Scale (DCS) for primary outcome, knowledge of epidural anesthesia and satisfaction with decision making for secondary outcomes, and decision of anesthesia usage (i.e., with epidural anesthesia, without epidural anesthesia, or undecided', 'undecided rate', 'DCS score']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",300.0,0.0628988,Knowledge of epidural anesthesia and satisfaction with decision-making scores of women who used the DA were significantly higher than those of women who used the pamphlet (p < .001).,"[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Shishido', 'Affiliation': ""St. Luke's International University, Tokyo, Japan.""}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Osaka', 'Affiliation': 'Keio University, Tokyo, Japan.'}, {'ForeName': 'Ayame', 'Initials': 'A', 'LastName': 'Henna', 'Affiliation': ""St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Motomura', 'Affiliation': 'Tokyo-Kita Medical Center, Tokyo, Japan.'}, {'ForeName': 'Shigeko', 'Initials': 'S', 'LastName': 'Horiuchi', 'Affiliation': ""St. Luke's International University, Tokyo, Japan.""}]",PloS one,['10.1371/journal.pone.0242351']
1845,33180863,Health education improves referral compliance of persons with probable Diabetic Retinopathy: A randomized controlled trial.,"OBJECTIVE


Lack of awareness about Diabetic Retinopathy (DR) is the most commonly cited reason why many persons with type 2 diabetes are non-compliant with referral instruction to undergo retinal screening. The purpose of this study was to evaluate the efficacy of a culturally, geographically and socially appropriate, locally adapted five-month-long health education on referral compliance of participants.
METHOD


A prospective randomized, open-label parallel group study was conducted on persons with type 2 diabetes who underwent basic eye screening at a diabetes hospital between September 2017 and August 2018. Participants who were noncompliant with referral instruction to visit a hospital for advanced DR management were randomly divided into health education intervention group (n = 143) and control group (n = 156). Both groups received information regarding DR and referral instruction at the diabetes hospital. The intervention group was provided personalized education followed by telephonic reminders. The primary endpoint was 'increase in referral compliance' and the secondary endpoint was 'increase in knowledge of DR'. Multivariate logistic regression model was used to identify significant predictors of compliance to referral.
RESULTS


A total of nine participants dropped and 290 completed the post intervention survey. The compliance rate in intervention group was found to be significantly higher than the control group (64.3% vs 28.2%; OR 4.73; 95% CI 2.87-7.79; p<0.001). Participants in the intervention group acquired better knowledge on DR (p<0.05). Apart from intervention, referral compliance rate was also found to be significantly associated with participants' self-perception of vision problem (OR 2.02; 95% CI 1.02-4.01; p = 0.045) and participants' income (OR 1.24; 95% CI 1.06-1.44; p = 0.008).
DISCUSSION


Our results suggest that intensive health education on DR should be integrated with diabetes education as it may result in significantly improved referral compliance. Outcomes may be sustainable if interventions are institutionalized at referral point.
TRIAL REGISTRATION


Clinical Trials.gov (Registration # NCT03658980); https://clinicaltrials.gov/ct2/show/NCT03658980.",2020,Participants in the intervention group acquired better knowledge on DR (p<0.05).,"['A total of nine participants dropped and 290 completed the post intervention survey', 'Participants who were noncompliant with referral instruction to visit a hospital for advanced DR management', 'persons with probable Diabetic Retinopathy', 'persons with type 2 diabetes who underwent basic eye screening at a diabetes hospital between September 2017 and August 2018', 'participants']","['Health education', 'personalized education followed by telephonic reminders', 'health education intervention', 'information regarding DR and referral instruction']","['referral compliance', 'knowledge of DR', 'referral compliance rate', 'compliance rate', ""participants' self-perception of vision problem""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589354', 'cui_str': 'Advanced retinal disease with diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}]",9.0,0.0459428,Participants in the intervention group acquired better knowledge on DR (p<0.05).,"[{'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Khair', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Md Moshiur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Kazawa', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Jahan', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Abu S G', 'Initials': 'ASG', 'LastName': 'Faruque', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammod Jobayer', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b), Dhaka, Bangladesh.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Moriyama', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",PloS one,['10.1371/journal.pone.0242047']
1846,33181169,Transcutaneous application of the gaseous CO 2  for improvement of the microvascular function in patients with diabetic foot ulcers.,"INTRODUCTION


Microvascular function is impaired in patients with diabetes mellitus (DM) and is involved in numerous DM complications. Several microvascular-supporting interventions have been proposed of which the transcutaneous application of gaseous CO 2  (hereinafter CO 2  therapy) is one of the most promising. The aim of present study was to determine the effect of repeated CO 2  therapies on the cutaneous microvascular function in DM patients with diabetic foot ulcers.
METHODOLOGY


A total of 42 subjects with at least one chronic diabetic foot ulcer were enrolled in the study. They were divided into the experimental group (21 subjects aged 64.6 ± 11.6 years) that underwent 4-week-long treatment with transcutaneous application of gaseous CO 2  (hereinafter CO 2  therapies), and the placebo group (21 subjects aged 65.0 ± 10.7 years) that underwent 4-week-long placebo treatment with transcutaneous application of air. Before the first and after the last treatment in both groups, laser Doppler (LD) flux in foot cutaneous microcirculation, heart rate, and arterial blood pressure measurements were carried out during rest and local thermal hyperaemia (LTH) provocation test.
RESULTS


In the experimental group the following statistically significant changes were observed after the completed treatment 1) increased mean relative powers of LD flux signals during rest in the frequency bands related to NO-independent endothelial (0.07 ± 0.055 vs. 0.048 ± 0.059, p = 0.0058), NO-mediated endothelial (0.154 ± 0.101 vs. 0.113 ± 0.108, p = 0.015), and neurogenic (0.17 ± 0.107 vs. 0.136 ± 0.098, p = 0.018) activity; 2) decreased resting LD flux (35 ± 29 PU vs. 52 ± 56 PU; p = 0.038); and 3) increased peak LD flux as a function of baseline during LTH (482 ± 474%BL vs. 287 ± 262%BL, p = 0.036); there were no statistically significant changes observed in the placebo group. No systemic effects were observed in none of the two groups by means of mean values of heart rate and arterial blood pressure.
CONCLUSIONS


Repeated CO 2  therapies improves the microvasular function in DM patients without any systemic side effects.",2020,"No systemic effects were observed in none of the two groups by means of mean values of heart rate and arterial blood pressure.
","['group (21 subjects aged 65.0±10.7\u202fyears) that underwent', 'patients with diabetes mellitus (DM', 'patients with diabetic foot ulcers', 'DM patients with diabetic foot ulcers', '42 subjects with at least one chronic diabetic foot ulcer', '21 subjects aged 64.6±11.6\u202fyears) that underwent']","['4-week-long treatment with transcutaneous application of gaseous CO 2  (hereinafter CO 2  therapies), and the placebo', 'placebo', 'CO 2  therapies', '4-week-long placebo treatment with transcutaneous application of air']","['laser Doppler (LD) flux in foot cutaneous microcirculation, heart rate, and arterial blood pressure measurements', 'systemic effects', 'neurogenic', 'mean relative powers of LD flux signals', 'NO-mediated endothelial', 'mean values of heart rate and arterial blood pressure', 'cutaneous microvascular function', 'resting LD flux', 'peak LD flux', 'microvasular function', 'microvascular function']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",42.0,0.0947368,"No systemic effects were observed in none of the two groups by means of mean values of heart rate and arterial blood pressure.
","[{'ForeName': 'Miha', 'Initials': 'M', 'LastName': 'Finžgar', 'Affiliation': 'Faculty of Mechanical Engineering, University of Ljubljana, Aškerčeva c. 6, Ljubljana, Slovenia.'}, {'ForeName': 'Helena Ban', 'Initials': 'HB', 'LastName': 'Frangež', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Ljubljana, Šlajmerjeva ul. 3, 1000 Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Cankar', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, University of Ljubljana, Zaloška c. 4, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Frangež', 'Affiliation': 'Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; Department of Surgical Infections, University Medical Centre Ljubljana, Zaloška c. 2, 1000 Ljubljana, Slovenia. Electronic address: ifrangez@gmail.com.'}]",Microvascular research,['10.1016/j.mvr.2020.104100']
1847,33195361,Improvement of Aspects of Subjective Sleep Quality of Healthy Volunteers by Ingestion of Porcine Placental Extract: A Randomized Cross-Over Pilot Study.,"Objectives:  This study assessed the effects of oral porcine placental extract (PPE) on sleep quality of healthy volunteers not satisfied with their sleep.  Design:  This study used a randomized, placebo-controlled, double-blind, cross-over clinical pilot study.  Setting:  This study was conducted under an outpatient multicenter setting in Japan.  Interventions:  A total of 20 healthy Japanese volunteers aged between 28 and 73, whose Pittsburgh Sleep Quality Index global scores were between 6 and 10, successfully completed the study. At first, PPE at 300 mg/kg or placebo was ingested for 2 weeks. Then, after a 2-week washout period, each group ingested under a cross-over setting the opposite sample (placebo or PPE) for another 2 weeks.  Main Outcome Measures:  Objective measurement of the sleep made with an activity tracker and subjective measurements of sleep quality by use of St. Mary's Hospital Sleep Questionnaire were done just before and after the administration time slots.  Results:  No effect of PPE on the sleep length was observed. Several measures in the subjective St. Mary's Hospital Sleep Questionnaire, i.e., changes in Q5 (sleep depth) and Q9 (sleep wellness) between pre- and post-ingestions, were significantly different between groups in the direction of improvement of subjective sleep quality in the PPE group.  Conclusions:  Although oral PPE at 300 mg/day for 2 weeks did not affect the length of sleep itself, it significantly improved several measures of subjective sleep quality. These results suggest that PPE might be a way to improve sleep quality without hypnotic drugs.  Clinical Trial Registration:  www.umin.ac.jp/ctr/, identifier: UMIN000026468.",2020,"Although oral PPE at 300 mg/day for 2 weeks did not affect the length of sleep itself, it significantly improved several measures of subjective sleep quality.","['outpatient multicenter setting in Japan', 'Healthy Volunteers', '20 healthy Japanese volunteers aged between 28 and 73, whose Pittsburgh Sleep Quality Index global scores were between 6 and 10, successfully completed the study', 'healthy volunteers not satisfied with their sleep']","['PPE', 'Porcine Placental Extract', 'placebo', 'cross-over setting the opposite sample (placebo or PPE', 'oral PPE', 'oral porcine placental extract (PPE']","['subjective sleep quality', 'length of sleep itself', ""subjective St. Mary's Hospital Sleep Questionnaire, i.e., changes in Q5 (sleep depth) and Q9 (sleep wellness"", ""Objective measurement of the sleep made with an activity tracker and subjective measurements of sleep quality by use of St. Mary's Hospital Sleep Questionnaire"", 'Subjective Sleep Quality', 'sleep length', 'sleep quality']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",20.0,0.0503117,"Although oral PPE at 300 mg/day for 2 weeks did not affect the length of sleep itself, it significantly improved several measures of subjective sleep quality.","[{'ForeName': 'Mahiko', 'Initials': 'M', 'LastName': 'Nagase', 'Affiliation': 'Kichijoji Traditional Chinese Medicine Clinic, Tokyo, Japan.'}, {'ForeName': 'Chiharu', 'Initials': 'C', 'LastName': 'Watanabe', 'Affiliation': 'Chiharu Dermatology Clinic, Saitama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kitanohara', 'Affiliation': ""Kitanohara Women's Clinic, Miyagi, Japan.""}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Nishiya', 'Affiliation': 'Hibikinomori Clinic, Hokkaido, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Medical Education, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Ohishi', 'Affiliation': 'Snowden Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Komatsu', 'Affiliation': 'Snowden Co., Ltd., Tokyo, Japan.'}]",Frontiers in nutrition,['10.3389/fnut.2020.550287']
1848,33195362,Design and Characterisation of a Randomized Food Intervention That Mimics Exposure to a Typical UK Diet to Provide Urine Samples for Identification and Validation of Metabolite Biomarkers of Food Intake.,"Poor dietary choices are major risk factors for obesity and non-communicable diseases, which places an increasing burden on healthcare systems worldwide. To monitor the effectiveness of healthy eating guidelines and strategies, there is a need for objective measures of dietary intake in community settings. Metabolites derived from specific foods present in urine samples can provide objective biomarkers of food intake (BFIs). Whilst the majority of biomarker discovery/validation studies have investigated potential biomarkers for single foods only, this study considered the whole diet by using menus that delivered a wide range of foods in meals that emulated conventional UK eating patterns. Fifty-one healthy participants (range 19-77 years; 57% female) followed a uniquely designed, randomized controlled dietary intervention, and provided spot urine samples suitable for discovery of BFIs within a real-world context. Free-living participants prepared and consumed all foods and drinks in their own homes and were asked to follow the protocols for meal consumption and home urine sample collection. This study also assessed the robustness, and impact on data quality, of a minimally invasive urine collection protocol. Overall the study design was well-accepted by participants and concluded successfully without any drop outs. Compliance for urine collection, adherence to menu plans, and observance of recommended meal timings, was shown to be very high. Metabolome analysis using mass spectrometry coupled with data mining demonstrated that the study protocol was well-suited for BFI discovery and validation. Novel, putative biomarkers for an extended range of foods were identified including legumes, curry, strongly-heated products, and artificially sweetened, low calorie beverages. In conclusion, aspects of this study design would help to overcome several current challenges in the development of BFI technology. One specific attribute was the examination of BFI generalizability across related food groups and across different preparations and cooking methods of foods. Furthermore, the collection of urine samples at multiple time points helped to determine which spot sample was optimal for identification and validation of BFIs in free-living individuals. A further valuable design feature centered on the comprehensiveness of the menu design which allowed the testing of biomarker specificity within a biobank of urine samples.",2020,"Novel, putative biomarkers for an extended range of foods were identified including legumes, curry, strongly-heated products, and artificially sweetened, low calorie beverages.",['Fifty-one healthy participants (range 19-77 years; 57% female'],['Food Intervention'],['BFI generalizability'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],51.0,0.04636,"Novel, putative biomarkers for an extended range of foods were identified including legumes, curry, strongly-heated products, and artificially sweetened, low calorie beverages.","[{'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, United Kingdom.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Lloyd', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, United Kingdom.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, United Kingdom.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Stiegler', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, United Kingdom.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Tailliart', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, United Kingdom.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garcia-Perez', 'Affiliation': 'Nutrition and Dietetic Research Group, Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Chambers', 'Affiliation': 'Nutrition and Dietetic Research Group, Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Beckmann', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Draper', 'Affiliation': 'Institute of Biological, Environmental and Rural Sciences, Aberystwyth University, Aberystwyth, United Kingdom.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, United Kingdom.'}]",Frontiers in nutrition,['10.3389/fnut.2020.561010']
1849,33195785,Effects of initiating physician-performed germline testing in safety net clinic patients with epithelial overian cancer.,"Germline genetic mutations occur in approximately 25% of women with epithelial ovarian cancers (EOC). We sought to determine whether newly initiated in-office oncologist-led germline testing improved time to testing and dissemination of results compared with historical controls. Patients with epithelial ovarian cancer seen between 4/1/2018 and 12/31/2019 were identified. Patients treated before genetic testing kits were made available in the gynecologic oncology clinics were compared to those treated after. Categorical variables were compared using Chi Squared and Fisher's Exact test. Cox proportional hazards model was used to compare elapsed time from testing to results. 73 patients were identified, and 502 clinic visits were analyzed. 56 (76.7%) patients were White Hispanic, 15 (20.5%) were Black, and 2 (2.7%) were White non-Hispanic. 55 (75.7%) underwent germline testing. Median time to genetic testing in the intervention group was shorter than in the control group (5, vs 24.3 weeks, 95% CI = 0-10.8 vs 14.9-33.7, p < 0.001). Among the 51 patients with genetic tests completed; results were recorded in a clinic note at 14 weeks (95% CI = 0-28.1) from first visit in the intervention group compared with 47 weeks (95% CI = 30.7-63.3) in the control group (p < 0.001). The majority of patients tested had county charity care insurance or were uninsured. Genetic testing in a safety net gynecologic oncology clinic is feasible. By initiating in-office testing, time to testing and receipt of results were meaningfully shortened. This allowed for timely identification of patients who would most benefit from PARP inhibitor maintenance therapy.",2020,"Median time to genetic testing in the intervention group was shorter than in the control group (5, vs 24.3 weeks, 95% CI = 0-10.8 vs 14.9-33.7, p < 0.001).","['73 patients were identified, and 502 clinic visits were analyzed', 'women with epithelial ovarian cancers (EOC', '56 (76.7%) patients were White Hispanic, 15 (20.5%) were Black, and 2 (2.7%) were White non-Hispanic. 55 (75.7', 'Patients with epithelial ovarian cancer seen between 4/1/2018 and 12/31/2019 were identified', 'clinic patients with epithelial overian cancer', 'patients who would most benefit from PARP inhibitor maintenance therapy', 'patients tested had county charity care insurance or were uninsured']",['initiating physician-performed germline testing'],['Median time to genetic testing'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C1533020', 'cui_str': 'Hispanic, white'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]",73.0,0.0736164,"Median time to genetic testing in the intervention group was shorter than in the control group (5, vs 24.3 weeks, 95% CI = 0-10.8 vs 14.9-33.7, p < 0.001).","[{'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Jordan', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Spring', 'Affiliation': 'University of Miami Miller School of Medicine, United States.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Kamath', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Schlumbrecht', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Matthew Pearson', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}, {'ForeName': 'Abdulrahman K', 'Initials': 'AK', 'LastName': 'Sinno', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}, {'ForeName': 'Sophia H L', 'Initials': 'SHL', 'LastName': 'George', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'University of Miami Sylvester Comprehensive Cancer Center Division of Gynecologic Oncology, United States.'}]",Gynecologic oncology reports,['10.1016/j.gore.2020.100662']
1850,33195809,Effectiveness of dexamethasone injection in the pterygomandibular space before and after lower third molar surgery.,"Background


Previous studies have investigated the effects of dexamethasone injections into the pterygomandibular space and compared them to those of controls; however, the effects of dexamethasone injections before and after lower third molar surgery on postoperative complications have not been studied. This research investigated the postoperative sequelae of dexamethasone injections before and after surgery into the pterygomandibular space. The aim of this study was to evaluate the effects of preoperative and postoperative injections of 4 mg of dexamethasone into the pterygomandibular space on postoperative pain, facial swelling, and the restriction of mouth opening following lower third molar surgical removal.
Methods


Twenty-seven participants with bilateral symmetrical lower impacted third molars were included in this study. Each participant was randomly allocated to one of two groups. Group A received injections of 1 ml dexamethasone (4 mg/mL) and 1 mL placebo into the pterygomandibular space before and after surgery, respectively. Group B received the same doses of placebo before surgery and dexamethasone after surgery.
Results


A significant restriction of mouth opening on the second postoperative day was observed in both groups. Nonetheless, the postoperative restriction of mouth opening, facial swelling, postoperative pain, and analgesic consumption after lower third molar surgical removal were not significantly different in the two groups.
Conclusions


Regardless of the time of administration, dexamethasone injections into the pterygomandibular space resulted in satisfactory control of the postoperative sequelae of the mandibular third molar surgical removal.",2020,A significant restriction of mouth opening on the second postoperative day was observed in both groups.,['Methods\n\n\nTwenty-seven participants with bilateral symmetrical lower impacted third molars'],"['dexamethasone injections', 'dexamethasone', 'placebo', 'injections of 1 ml dexamethasone', 'dexamethasone injection']","['postoperative restriction of mouth opening, facial swelling, postoperative pain, and analgesic consumption', 'postoperative pain, facial swelling, and the restriction of mouth opening']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C4283889', 'cui_str': 'Dexamethasone Injection'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",27.0,0.230535,A significant restriction of mouth opening on the second postoperative day was observed in both groups.,"[{'ForeName': 'Kalaya', 'Initials': 'K', 'LastName': 'Sitthisongkhram', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nattisa', 'Initials': 'N', 'LastName': 'Niyomtham', 'Affiliation': 'International College of Dentistry, Walailak University, Bangkok, Thailand.'}, {'ForeName': 'Teeranut', 'Initials': 'T', 'LastName': 'Chaiyasamut', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Verasak', 'Initials': 'V', 'LastName': 'Pairuchvej', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Kc', 'Affiliation': 'Department of Oral Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthamet', 'Initials': 'N', 'LastName': 'Wongsirichat', 'Affiliation': 'International College of Dentistry, Walailak University, Bangkok, Thailand.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.5.313']
1851,33195874,Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids).,"Background


As many as 40% of the 1 million children living with HIV (CLHIV) receiving antiretroviral treatment (ART) in resource limited settings have not achieved viral suppression (VS). Kenya has a large burden of pediatric HIV with nearly 140,000 CLHIV. Feasible, scalable, and cost-effective approaches to ensure VS in CLHIV are urgently needed. The goal of this study is to determine the feasibility and impact of point-of-care (POC) viral load (VL) and targeted drug resistance mutation (DRM) testing to improve VS in children on ART in Kenya.
Methods


We are conducting a randomized controlled study to evaluate the use of POC VL and targeted DRM testing among 704 children aged 1-14 years on ART at health facilities in western Kenya. Children are randomized 1:1 to intervention (higher frequency POC VL and targeted DRM testing) vs. control (standard-of-care) arms and followed for 12 months. Our primary outcome is VS (VL < 1000 copies/mL) 12 months after enrollment by study arm. Secondary outcomes include time to VS and the impact of targeted DRM testing on VS. In addition, key informant interviews with patients and providers will generate an understanding of how the POC VL intervention functions. Finally, we will model the cost-effectiveness of POC VL combined with targeted DRM testing.
Discussion


This study will provide critical information on the impact of POC VL and DRM testing on VS among CLHIV on ART in a resource-limited setting and directly address the need to find approaches that maximize VS among children on ART.
Trials registration


NCT03820323.",2020,We are conducting a randomized controlled study to evaluate the use of POC VL and targeted DRM testing among 704 children aged 1-14 years on ART at health facilities in western Kenya.,"['children on ART in Kenya', '704 children aged 1-14 years on ART at health facilities in western Kenya', '1 million children living with HIV (CLHIV) receiving antiretroviral treatment (ART', 'Kenyan children on antiretroviral therapy (Opt4Kids']","['POC VL and targeted DRM', 'POC VL combined with targeted DRM testing', 'point-of-care (POC) viral load (VL) and targeted drug resistance mutation (DRM) testing']",['time to VS and the impact of targeted DRM testing on VS'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",704.0,0.128497,We are conducting a randomized controlled study to evaluate the use of POC VL and targeted DRM testing among 704 children aged 1-14 years on ART at health facilities in western Kenya.,"[{'ForeName': 'Rena C', 'Initials': 'RC', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Oyaro', 'Affiliation': 'Health Innovations Kenya (HIK), Kenya.'}, {'ForeName': 'Beryne', 'Initials': 'B', 'LastName': 'Odeny', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Mukui', 'Affiliation': 'Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wagude', 'Affiliation': 'Department of Health, Kisumu County, Kenya.'}, {'ForeName': 'Eunice', 'Initials': 'E', 'LastName': 'Kinywa', 'Affiliation': 'Department of Health, Kisumu County, Kenya.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Oluoch', 'Affiliation': 'Department of Health, Kisumu County, Kenya.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Odhiambo', 'Affiliation': 'Family AIDS Care and Education Services, Kenya Medical Research Institute, Kisumu, Kenya.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Oyaro', 'Affiliation': 'Kenya Medical Research Institute-CDC, Kisian, Kenya.'}, {'ForeName': 'Grace C', 'Initials': 'GC', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Abuogi', 'Affiliation': 'Department of Pediatrics, University of Colorado, Denver, CO, United States.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100673']
1852,33195869,Effects of pelvic floor muscle training in pregnant women.,"Objective


The aim is to verify the effectiveness of the pelvic floor muscle training (PFMT) program in pregnant women, by analyzing the amount of urine leakage.
Design


Experimental study.
Location


Care units in the Vila Real district, Portugal.
Participants


Forty-three pregnant women divided into an experimental group (EG) (n = 22) and a control group (CG) (n = 21).
Interventions


Both groups were evaluated in a predelivery stage (initial) and 6 months after delivery (final). The EG was given a PFMT exercise protocol with a duration of 6 weeks, applicable in classes and at home, another PFMT protocol for 9 weeks.
Main measurements


The strength of the pelvic floor muscle was measured by the  Oxford Grading Scale  and the amount of urine was assessed with a Pad test. Quality of life was measured by the King's Health Questionnaire and self-efficacy by the Broome Pelvic Muscle Self-Efficacy Scale.
Results


The loss of urine, significantly reduced from 0.86 ± 0.83 to 0.50 ± 0.67 in the EG ( P  = .021), whereas in the CG no significant change was observed. The degree of muscle contraction increased by 4.82 ± 0.39 in EG and 3.95 ± 0.67 in CG. The quality of life observed significant improvements in both groups ( P  < .05). As for self-efficacy, for the EG it improved significantly - initial ( P  = .001), final ( P  = .031), and for the CG the values remained the same.
Conclusions


This PFMT protocol reduced urinary incontinence in pregnant women. The program allowed significant improvement in the quantity of urinary leakage and an increase in the strength of the pelvic floor muscle.",2020,"As for self-efficacy, for the EG it improved significantly - initial ( P  = .001), final ( P  = .031), and for the CG the values remained the same.
","['pregnant women', 'Participants\n\n\nForty-three pregnant women']","['pelvic floor muscle training (PFMT) program', 'pelvic floor muscle training', 'control group (CG', 'PFMT exercise protocol']","['quantity of urinary leakage', 'degree of muscle contraction', 'urinary incontinence', ""King's Health Questionnaire and self-efficacy by the Broome Pelvic Muscle Self-Efficacy Scale"", 'strength of the pelvic floor muscle', 'Quality of life', 'quality of life', 'loss of urine']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0448421', 'cui_str': 'Skeletal muscle structure of pelvis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042036', 'cui_str': 'Urine'}]",43.0,0.0175175,"As for self-efficacy, for the EG it improved significantly - initial ( P  = .001), final ( P  = .031), and for the CG the values remained the same.
","[{'ForeName': 'Telma F', 'Initials': 'TF', 'LastName': 'Pires', 'Affiliation': 'University of Trás-os-Montes e Alto Douro, Vila Real.'}, {'ForeName': 'Patrícia M', 'Initials': 'PM', 'LastName': 'Pires', 'Affiliation': 'University of Trás-os-Montes e Alto Douro, Vila Real.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Costa', 'Affiliation': 'University of Aveiro, Aveiro.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Viana', 'Affiliation': 'Hospital de S. João - Porto/University of Fernando Pessoa, Porto, Portugal.'}]",Porto biomedical journal,['10.1097/j.pbj.0000000000000077']
1853,33196110,Magnetic needle-tracking device for ultrasound guidance of radial artery puncture: A randomized study on a simulation model.,"INTRODUCTION


Ultrasound-guidance of radial artery catheter insertion improves the first attempt success and reduces the occurrence of hematomas. Needle-tracking devices optimize needle-ultrasound beam alignment by displaying in real-time the needle tip position. We compared the median time need by experienced physicians to achieve radial artery puncture using either a conventional ultrasonography device (CUD) or a magnetic needle-tracking ultrasound device (MUD) in a simulation training arm model.
METHODS


Fifty experienced residents and physicians performed two punctures in randomized order with the CUD and the MUD. The primary outcome was puncture duration; the secondary outcomes were puncture success, rate of accidental vein puncture, and practitioner's comfort (subjective scale 0-10).
RESULTS


The median [lower-upper quartile] puncture time was 10 [6-14] seconds when using CUD and 4 [3-7] seconds when using MUD (P < .01). In the multivariate analysis, MUD use was associated with decreased puncture duration whatever the puncture order (OR 1.13 [1.07-1.20], P < .01). The participants performed 99 (99%) successful punctures: 50 with the MUD (100%) and 49 with the CUD (98%). There was no accidental venous puncture. The practitioner's comfort level was 6.5 [6, 7] with the CUD and 8 [7-9] with the MUD (P < .01).
CONCLUSION


MUD reduced radial artery puncture time and improved physician comfort in a simulation training arm model.",2020,"In the multivariate analysis, MUD use was associated with decreased puncture duration whatever the puncture order (OR 1.13 [1.07-1.20], P < .01).","['Fifty experienced residents and physicians performed two punctures in randomized order with the CUD and the MUD', 'radial artery puncture']","['Magnetic needle-tracking device', 'radial artery catheter insertion', 'conventional ultrasonography device (CUD) or a magnetic needle-tracking ultrasound device (MUD']","['radial artery puncture time and improved physician comfort', 'median [lower-upper quartile] puncture time', 'accidental venous puncture', ""puncture duration; the secondary outcomes were puncture success, rate of accidental vein puncture, and practitioner's comfort (subjective scale 0-10"", 'puncture duration']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0522560', 'cui_str': 'Needle track'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0522560', 'cui_str': 'Needle track'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0340778', 'cui_str': 'Venous puncture'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0530628,"In the multivariate analysis, MUD use was associated with decreased puncture duration whatever the puncture order (OR 1.13 [1.07-1.20], P < .01).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grau-Mercier', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Chetioui', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Muller', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Roger', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Genre Grandpierre', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Jean Emmanuel', 'Initials': 'JE', 'LastName': 'de La Coussaye', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cuvillon', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Pierre-Géraud', 'Initials': 'PG', 'LastName': 'Claret', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bobbia', 'Affiliation': 'Montpellier University, Department of Anesthesiology, Emergency and Critical Care Medicine, Intensive Care Unit, Nîmes University Hospital, Nîmes, France.'}]",Journal of clinical ultrasound : JCU,['10.1002/jcu.22945']
1854,33196146,Treatment effect with 2 photorefractive intrastromal cross-linking protocols in low-grade myopia through 24-month follow-up.,"PURPOSE


To assess the effect of two high-oxygen epi-on PiXL treatments for low-grade myopia.
METHODS


This prospective, randomized, intra-individually comparing, single-masked study included 23 healthy volunteers (46 eyes) aged 18-35 years with mild myopia, -0.75 to -2.50 D manifest refractive spherical equivalent (MRSE). One eye was randomized to a 4.0-mm homogenous treatment zone and the fellow eye to a 4.0-mm annular zone (16:40 min at 30 mW/cm 2  , fluence 15 J/cm 2  ). Uncorrected distance visual acuity (UDVA), MRSE, best spectacle-corrected visual acuity (BSCVA), Scheimpflug light scattering depths, mean keratometry (K mean  ) and endothelial cell count (ECC) were assessed through 24 months.
RESULTS


Similar improvements in UDVA were seen for the homogeneous and annular protocols at 1 month: -0.52 (-0.59, -0.39) and -0.49 (-0.59, -0.39) logMAR, respectively (medians and interquartile ranges, IQR), p = 0.91, and MRSE: +1.0 D (0.94, 1.31) and +1.0 D (0.69, 1.25), p = 0.17. Light scattering depths were 496 (465, 527) and 349 (247, 378) µm, respectively, and the reduction in mean keratometry was -0.8 D (-1.1, -0.7) and 0 D (-0.1, 0.1), p < 0.001. The treatment effect remained stable throughout 24 months. At 1 week, the participants reported less ocular discomfort with the annular protocol. No reductions were seen in BSCVA or ECC. No adverse events were reported.
CONCLUSION


PiXL can reduce low-grade myopia and improve uncorrected vision in healthy eyes. The initial ocular discomfort may be reduced with an annular treatment zone. Further studies are needed to optimize PiXL treatment parameters.",2020,"RESULTS


Similar improvements in UDVA were seen for the homogeneous and annular protocols at 1 month: -0.52","['healthy eyes', '23 healthy volunteers (46 eyes) aged 18-35\xa0years with mild myopia, -0.75 to -2.50 D manifest refractive spherical equivalent (MRSE', 'low-grade myopia']","['high-oxygen epi-on PiXL', '2 photorefractive intrastromal cross-linking protocols', 'PiXL']","['uncorrected vision', 'ocular discomfort', 'BSCVA or ECC', 'mean keratometry', 'adverse events', 'low-grade myopia', 'Light scattering depths', 'Uncorrected distance visual acuity (UDVA), MRSE, best spectacle-corrected visual acuity (BSCVA), Scheimpflug light scattering depths, mean keratometry (K mean  ) and endothelial cell count (ECC', 'UDVA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}, {'cui': 'C4077283', 'cui_str': '67Ga-ethylenecysteamine cysteine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}]",23.0,0.103218,"RESULTS


Similar improvements in UDVA were seen for the homogeneous and annular protocols at 1 month: -0.52","[{'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Näslund', 'Affiliation': 'Department of Clinical Science/Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Fredriksson', 'Affiliation': 'Department of Clinical Science/Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Alm', 'Affiliation': 'Department of Clinical Science/Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Jeannette Beckman', 'Initials': 'JB', 'LastName': 'Rehnman', 'Affiliation': 'Department of Clinical Science/Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Behndig', 'Affiliation': 'Department of Clinical Science/Ophthalmology, Umeå University, Umeå, Sweden.'}]",Acta ophthalmologica,['10.1111/aos.14669']
1855,33196153,Evinacumab in Patients with Refractory Hypercholesterolemia.,"BACKGROUND


Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels despite treatment with lipid-lowering therapies at maximum tolerated doses, have an increased risk of atherosclerosis. In such patients, the efficacy and safety of subcutaneous and intravenous evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, are not known.
METHODS


In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis. Patients were randomly assigned to receive subcutaneous or intravenous evinacumab or placebo. The primary end point was the percent change from baseline in the LDL cholesterol level at week 16 with evinacumab as compared with placebo.
RESULTS


In total, 272 patients were randomly assigned to the following groups: subcutaneous evinacumab at a dose of 450 mg weekly (40 patients), 300 mg weekly (43 patients), or 300 mg every 2 weeks (39 patients) or placebo (41 patients); or intravenous evinacumab at a dose of 15 mg per kilogram of body weight every 4 weeks (39 patients) or 5 mg per kilogram every 4 weeks (36 patients) or placebo (34 patients). At week 16, the differences in the least-squares mean change from baseline in the LDL cholesterol level between the groups assigned to receive subcutaneous evinacumab at a dose of 450 mg weekly, 300 mg weekly, and 300 mg every 2 weeks and the placebo group were -56.0, -52.9, and -38.5 percentage points, respectively (P<0.001 for all comparisons). The differences between the groups assigned to receive intravenous evinacumab at a dose of 15 mg per kilogram and 5 mg per kilogram and the placebo group were -50.5 percentage points (P<0.001) and -24.2 percentage points, respectively. The incidence of serious adverse events during the treatment period ranged from 3 to 16% across trial groups.
CONCLUSIONS


In patients with refractory hypercholesterolemia, the use of evinacumab significantly reduced the LDL cholesterol level, by more than 50% at the maximum dose. (Funded by Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT03175367.).",2020,"In patients with refractory hypercholesterolemia, the use of evinacumab significantly reduced the LDL cholesterol level, by more than 50% at the maximum dose.","['patients with refractory hypercholesterolemia', 'Patients with Refractory Hypercholesterolemia', '272 patients', 'Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels', 'enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis']","['subcutaneous or intravenous evinacumab or placebo', 'subcutaneous and intravenous evinacumab', 'Evinacumab', 'subcutaneous evinacumab', 'placebo', 'intravenous evinacumab']","['efficacy and safety', 'incidence of serious adverse events', 'LDL cholesterol level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}]",272.0,0.588401,"In patients with refractory hypercholesterolemia, the use of evinacumab significantly reduced the LDL cholesterol level, by more than 50% at the maximum dose.","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Lesley J', 'Initials': 'LJ', 'LastName': 'Burgess', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Christoph F', 'Initials': 'CF', 'LastName': 'Ebenbichler', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Nagwa', 'Initials': 'N', 'LastName': 'Khilla', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hamlin', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Son', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) - both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton (S.J.B.); the Department of Vascular Medicine, Academic Medical Center, Amsterdam (E.S.G.S.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Montreal, and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC - both in Canada (D.G.).'}]",The New England journal of medicine,['10.1056/NEJMoa2031049']
1856,33196154,"N-of-1 Trial of a Statin, Placebo, or No Treatment to Assess Side Effects.",,2020,,[],"['Statin, Placebo']",[],[],"[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.187591,,"[{'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Wood', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Howard', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Finegold', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Nowbar', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Ahran D', 'Initials': 'AD', 'LastName': 'Arnold', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Rajkumar', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Jaimini', 'Initials': 'J', 'LastName': 'Cegla', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'Sheffield University Management School, Sheffield, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sever', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': ""King's College London, London, United Kingdom.""}, {'ForeName': 'Simon A M', 'Initials': 'SAM', 'LastName': 'Thom', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Shun-Shin', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'Imperial College London, London, United Kingdom.'}]",The New England journal of medicine,['10.1056/NEJMc2031173']
1857,33196155,Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.,"BACKGROUND


The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain.
METHODS


In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months.
RESULTS


A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups.
CONCLUSIONS


In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).",2020,"In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months.","['patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain', 'Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve', 'patients with atrial fibrillation and a bioprosthetic mitral valve', '1005 patients were enrolled at 49 sites in Brazil']","['dose-adjusted warfarin', 'rivaroxaban', 'Rivaroxaban', 'warfarin']","['Death from cardiovascular causes or thromboembolic events', 'frequency of other serious adverse events', 'mean survival time', 'Major bleeding', 'death, major cardiovascular events, or major bleeding', 'incidence of stroke', 'composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",1005.0,0.25033,"In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months.","[{'ForeName': 'Helio P', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Idelzuita L', 'Initials': 'IL', 'LastName': 'Liporace', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Roney O', 'Initials': 'RO', 'LastName': 'Sampaio', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Tarasoutchi', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann-Filho', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'de Lemos Soares Patriota', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Tiago L L', 'Initials': 'TLL', 'LastName': 'Leiria', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lamprea', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Dalton B', 'Initials': 'DB', 'LastName': 'Precoma', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Atik', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Silveira', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fabio R', 'Initials': 'FR', 'LastName': 'Farias', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Diogo O', 'Initials': 'DO', 'LastName': 'Barreto', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Adail P', 'Initials': 'AP', 'LastName': 'Almeida', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Zilli', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'de Souza Neto', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Cavalcante', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fernando A M S', 'Initials': 'FAMS', 'LastName': 'Figueira', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Flávia C S', 'Initials': 'FCS', 'LastName': 'Kojima', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Damiani', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Renato H N', 'Initials': 'RHN', 'LastName': 'Santos', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Nanci', 'Initials': 'N', 'LastName': 'Valeis', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Viviane B', 'Initials': 'VB', 'LastName': 'Campos', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Jose F K', 'Initials': 'JFK', 'LastName': 'Saraiva', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Francisco H', 'Initials': 'FH', 'LastName': 'Fonseca', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Ibraim M', 'Initials': 'IM', 'LastName': 'Pinto', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Magalhães', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Joao F M', 'Initials': 'JFM', 'LastName': 'Ferreira', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pavanello', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029603']
1858,33189178,"Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial.","BACKGROUND


Selinexor combined with dexamethasone has shown activity in patients with heavily pre-treated multiple myeloma. In a phase 1b/2 study, the combination of oral selinexor with bortezomib (a proteasome inhibitor) and dexamethasone induced high response rates with low rates of peripheral neuropathy, the main dose-limiting toxicity of bortezomib. We aimed to evaluate the clinical benefit of weekly selinexor, bortezomib, and dexamethasone versus standard bortezomib and dexamethasone in patients with previously treated multiple myeloma.
METHODS


This phase 3, randomised, open-label trial was done at 123 sites in 21 countries. Patients aged 18 years or older, who had multiple myeloma, and who had previously been treated with one to three lines of therapy, including proteasome inhibitors, were randomly allocated (1:1) to receive selinexor (100 mg once per week), bortezomib (1·3 mg/m 2  once per week), and dexamethasone (20 mg twice per week), or bortezomib (1·3 mg/m 2  twice per week for the first 24 weeks and once per week thereafter) and dexamethasone (20 mg four times per week for the first 24 weeks and twice per week thereafter). Randomisation was done using interactive response technology and stratified by previous proteasome inhibitor therapy, lines of treatment, and multiple myeloma stage. The primary endpoint was progression-free survival in the intention-to-treat population. Patients who received at least one dose of study treatment were included in the safety population. This trial is registered at ClinicalTrials.gov, NCT03110562. The trial is ongoing, with 55 patients remaining on randomised therapy as of Feb 20, 2020.
FINDINGS


Of 457 patients screened for eligibility, 402 were randomly allocated-195 (49%) to the selinexor, bortezomib, and dexamethasone group and 207 (51%) to the bortezomib and dexamethasone group-and the first dose of study medication was given between June 6, 2017, and Feb 5, 2019. Median follow-up durations were 13·2 months [IQR 6·2-19·8] for the selinexor, bortezomib, and dexamethasone group and 16·5 months [9·4-19·8] for the bortezomib and dexamethasone group. Median progression-free survival was 13·93 months (95% CI 11·73-not evaluable) with selinexor, bortezomib, and dexamethasone and 9·46 months (8·11-10·78) with bortezomib and dexamethasone (hazard ratio 0·70 [95% CI 0·53-0·93], p=0·0075). The most frequent grade 3-4 adverse events were thrombocytopenia (77 [39%] of 195 patients in the selinexor, bortezomib, and dexamethasone group vs 35 [17%] of 204 in the bortezomib and dexamethasone group), fatigue (26 [13%] vs two [1%]), anaemia (31 [16%] vs 20 [10%]), and pneumonia (22 [11%] vs 22 [11%]). Peripheral neuropathy of grade 2 or above was less frequent with selinexor, bortezomib, and dexamethasone (41 [21%] patients) than with bortezomib and dexamethasone (70 [34%] patients; odds ratio 0·50 [95% CI 0·32-0·79], p=0·0013). 47 (24%) patients in the selinexor, bortezomib, and dexamethasone group and 62 (30%) in the bortezomib and dexamethasone group died.
INTERPRETATION


A once-per-week regimen of selinexor, bortezomib, and dexamethasone is a novel, effective, and convenient treatment option for patients with multiple myeloma who have received one to three previous lines of therapy.
FUNDING


Karyopharm Therapeutics.",2020,"Peripheral neuropathy of grade 2 or above was less frequent with selinexor, bortezomib, and dexamethasone (41 [21%] patients) than with bortezomib and dexamethasone (70 [34%] patients; odds ratio 0·50","['123 sites in 21 countries', 'patients with multiple myeloma who have received one to three previous lines of therapy', 'Patients aged 18 years or older, who had multiple myeloma, and who had previously been treated with one to three lines of therapy, including proteasome inhibitors', '457 patients screened for eligibility, 402 were randomly allocated-195 (49%) to the', 'patients with multiple myeloma (BOSTON', '55 patients remaining on randomised therapy as of Feb 20, 2020', 'patients with previously treated multiple myeloma', 'Patients who received at least one dose of study treatment were included in the safety population', 'patients with heavily pre-treated multiple myeloma']","['selinexor, bortezomib', 'selinexor, bortezomib, and dexamethasone', 'bortezomib', 'bortezomib and dexamethasone', 'selinexor', 'selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone', 'dexamethasone', 'selinexor, bortezomib, and dexamethasone versus standard bortezomib and dexamethasone', 'oral selinexor with bortezomib']","['thrombocytopenia', 'fatigue', 'anaemia', 'progression-free survival', 'Median progression-free survival']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1443643', 'cui_str': 'Proteasome inhibitor'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.130375,"Peripheral neuropathy of grade 2 or above was less frequent with selinexor, bortezomib, and dexamethasone (41 [21%] patients) than with bortezomib and dexamethasone (70 [34%] patients; odds ratio 0·50","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Medical University of Silesia, Katowice, Poland. Electronic address: sgrosicki@wp.pl.'}, {'ForeName': 'Maryana', 'Initials': 'M', 'LastName': 'Simonova', 'Affiliation': 'Institute of Blood Pathology and Transfusion Medicine, National Academy of Medical Sciences of Ukraine, Lviv, Ukraine.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': 'Charles University and General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'Clinic of Internal Medicine-Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Iryrna', 'Initials': 'I', 'LastName': 'Kriachok', 'Affiliation': 'National Cancer Institute Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gavriatopoulou', 'Affiliation': 'Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Halyna', 'Initials': 'H', 'LastName': 'Pylypenko', 'Affiliation': 'Department of Hematology, Cherkassy Regional Oncological Center, Cherkassy, Ukraine.'}, {'ForeName': 'Holger W', 'Initials': 'HW', 'LastName': 'Auner', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Department of Hematology, CHU la Miletrie and Inserm CIC 1402, Poitiers, France.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Doronin', 'Affiliation': 'City Clinical Hospital No. 40, Moscow, Russia.'}, {'ForeName': 'Ganna', 'Initials': 'G', 'LastName': 'Usenko', 'Affiliation': 'City Clinical Hospital 4 of Dnipro City Council, City Hematology Center, Dnipro, Ukraine.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Charbonneau Cancer Research Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hemato-oncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Benjamin', 'Affiliation': 'Kings College NHS Foundation Trust, Kings College London, London, UK.'}, {'ForeName': 'Tuphan K', 'Initials': 'TK', 'LastName': 'Dolai', 'Affiliation': 'Nil Ratan Sircar Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Dinesh K', 'Initials': 'DK', 'LastName': 'Sinha', 'Affiliation': 'State Cancer Institute, Indira Gandhi Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Venner', 'Affiliation': 'Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Garg', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Gironella', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Jurczyszyn', 'Affiliation': 'Department of Hematology, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Robak', 'Affiliation': 'Department of Hematology, Copernicus Memorial Hospital, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Wallington-Beddoe', 'Affiliation': 'Flinders Medical Centre and Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Atanas', 'Initials': 'A', 'LastName': 'Radinoff', 'Affiliation': 'University Hospital ""St Ivan Rilski"" EAD, Sofia, Bulgaria.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Salogub', 'Affiliation': 'Chemotherapy of Oncology Diseases-Bone Marrow Transplantation Department 1, Almazov National Medical Research Centre, Ministry of Health of Russia, St Petersburg, Russia.'}, {'ForeName': 'Don A', 'Initials': 'DA', 'LastName': 'Stevens', 'Affiliation': 'Norton Cancer Institute, St Matthews Campus, Louisville, KY, USA.'}, {'ForeName': 'Supratik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'New Cross Hospital, Royal Wolverhampton NHS Trust and University of Wolverhampton, Wolverhampton, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Oncohematology Hospital S Maria Terni, University of Perugia, Terni, Italy.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Vesselina S', 'Initials': 'VS', 'LastName': 'Goranova-Marinova', 'Affiliation': 'University Hospital ""Sv Georgi"" EAD, Clinic of Clinical Hematology, Medical University of Plovdiv, Plovdiv, Bulgaria.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Bila', 'Affiliation': 'Clinic for Hematology, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Katodritou', 'Affiliation': 'Hematology Department, Theagenion Cancer Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Oliynyk', 'Affiliation': 'Department of Hematology, Vinnytsia M I Pyrohov Regional Clinical Hospital, Vinnytsia, Ukraine.'}, {'ForeName': 'Sybiryna', 'Initials': 'S', 'LastName': 'Korenkova', 'Affiliation': 'Bone Marrow Transplantation Department, Kyiv Bone Marrow Transplantation Center, Kyiv, Ukraine.'}, {'ForeName': 'Jeevan', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Tata Medical Center, Kolkata, India.'}, {'ForeName': 'Sundar', 'Initials': 'S', 'LastName': 'Jagannath', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital, Hotel-Dieu, Nantes, France.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'Baylor University Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Moshe E', 'Initials': 'ME', 'LastName': 'Gatt', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'CHU Lille Service des Maladies du Sang F-59000, Lille, France.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università degli Studi, Bologna, Italy.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reece', 'Affiliation': 'University Health Network-Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jean-Richard', 'Initials': 'JR', 'LastName': 'Saint-Martin', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jeha', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Anita A', 'Initials': 'AA', 'LastName': 'Joshi', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Vishnuvardhan', 'Initials': 'V', 'LastName': 'Peddagali', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Arazy', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Shacham', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Sosana', 'Initials': 'S', 'LastName': 'Delimpasi', 'Affiliation': 'General Hospital Evangelismos, Athens, Greece.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32292-3']
1859,33189208,A comparative assessment of Dorsal radial artery access versus classical radial artery access for percutaneous coronary angiography-a randomized control trial (DORA trial).,"OBJECTIVES


This is an open-label randomized control trial with a parallel assignment with single masking comparing patients undergoing coronary angiography via dorsal radial and classical radial access.
METHODS


Study done at three tertiary cardiac care centers for two years. A total of 970 patients were finally recruited for the study. Patients were randomly selected for dorsal radial artery access Group A (485 patients) and classical radial artery access Group B (485 patients) without any bias for age & sex.
RESULTS


On comparative assessment both techniques are found to be equal in terms of procedural success rate. While dorsal access was superior in terms of fewer incidences of forearm radial artery occlusion, radial artery spasm, less post-procedure persistence of pain, and hand clumsiness. In comparison to this, the number of puncture attempts and time to achieve post-procedure hemostasis is less in classical radial access.
CONCLUSION


So both techniques have pros and coins and it is the discretion of interventionists to adopt which technique.",2020,"While dorsal access was superior in terms of fewer incidences of forearm radial artery occlusion, radial artery spasm, less post-procedure persistence of pain, and hand clumsiness.","['A total of 970 patients were finally recruited for the study', 'patients undergoing coronary angiography via dorsal radial and classical radial access', 'Study done at three tertiary cardiac care centers for two years']","['Dorsal radial artery access versus classical radial artery access', 'percutaneous coronary angiography', 'dorsal radial artery access Group A (485 patients) and classical radial artery access Group B (485 patients) without any bias for age & sex']","['forearm radial artery occlusion, radial artery spasm, less post-procedure persistence of pain, and hand clumsiness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0233844', 'cui_str': 'Clumsiness'}]",970.0,0.0969067,"While dorsal access was superior in terms of fewer incidences of forearm radial artery occlusion, radial artery spasm, less post-procedure persistence of pain, and hand clumsiness.","[{'ForeName': 'Awadhesh Kumar', 'Initials': 'AK', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India. Electronic address: awakush@gmail.com.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Razi', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Prakash', 'Affiliation': 'Department of Cardiothoracic Surgury, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}, {'ForeName': 'Akhil', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiology, King George Medical University, Lucknow, UP, 226003, India.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Sarraf', 'Affiliation': 'Department of Cardiology, UP Institute of Medical Sciences, Saifai, Etawah, 206130, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}, {'ForeName': 'Umeshwar', 'Initials': 'U', 'LastName': 'Pandey', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Thakur', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Verma', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Krishna', 'Affiliation': 'Department of Cardiology, LPS Institute of Cardiology, Kanpur, UP, 208002, India.'}]",Indian heart journal,['10.1016/j.ihj.2020.06.002']
1860,33189370,[Perineural dexamethasone in ultrasound-guided interscalene brachial plexus block with levobupivacaine for shoulder arthroscopic surgery in the outpatient setting: randomized controlled trial].,"BACKGROUND AND OBJECTIVES


In shoulder arthroscopy, on an outpatient basis, the patient needs a good control of the postoperative pain that can be achieved through regional blocks. Perineural dexamethasone may prolong the effect of these blocks. The aim of this study was to evaluate the effect of perineural dexamethasone on the prolongation of the sensory block in the postoperative period for arthroscopic shoulder surgery in outpatient setting.
METHODS


After approval by the Research Ethics Committee and informed consent, patients undergoing arthroscopic shoulder surgery under general anesthesia and ultrasound-guided interscalene brachial plexus block were randomized into Group D - blockade performed with 30 mL of 0.5% levobupivacaine with vasoconstrictor and 6 mg (1.5 mL) of dexamethasone and Group C - 30 mL of 0.5% levobupivacaine with vasoconstrictor and 1.5 mL of 0.9% saline. The duration of the sensory block was evaluated in 4 postoperative moments (0, 4, 12 and 24 hours) as well as the need for rescue analgesia, nausea and vomiting incidence, and Visual Analog Pain Scale (VAS).
RESULTS


Seventy-four patients were recruited and 71 completed the study (Group C, n=37; Group D, n=34). Our findings showed a prolongation of the mean time of the sensitive blockade in Group D (1440±0 min vs. 1267±164 min, p<0.001). It was observed that Group C had a higher mean pain score according to VAS (2.08±1.72 vs. 0.02±0.17, p <0.001) and a greater number of patients (68.4% vs. 0%, p <0.001) required rescue analgesia in the first 24 hours. The incidence of postoperative nausea and vomiting was not statistically significant.
CONCLUSION


Perineural dexamethasone significantly prolonged the sensory blockade promoted by levobupivacaine in interscalene brachial plexus block, reduced pain intensity and rescue analgesia needs in the postoperative period.",2020,"It was observed that Group C had a higher mean pain score according to VAS (2.08±1.72 vs. 0.02±0.17, p <0.001) and a greater number of patients (68.4% vs. 0%, p <0.001) required rescue analgesia in the first 24 hours.","['Seventy-four patients were recruited and 71\xa0completed the study (Group\xa0C, n=37; Group\xa0D, n=34', 'patients undergoing arthroscopic shoulder surgery under general anesthesia and ultrasound-guided interscalene brachial plexus block', 'arthroscopic shoulder surgery in outpatient setting']","['levobupivacaine with vasoconstrictor', 'perineural dexamethasone', 'dexamethasone and Group C - 30\xa0mL of 0.5%\xa0levobupivacaine with vasoconstrictor and 1.5\xa0mL of\xa00.9% saline', 'dexamethasone', 'levobupivacaine', 'Perineural dexamethasone']","['mean pain score', 'mean time of the sensitive blockade', 'postoperative nausea and vomiting', 'pain intensity and rescue analgesia needs', 'rescue analgesia, nausea and vomiting incidence, and Visual Analog Pain Scale (VAS', 'rescue analgesia', 'duration of the sensory block']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",74.0,0.159529,"It was observed that Group C had a higher mean pain score according to VAS (2.08±1.72 vs. 0.02±0.17, p <0.001) and a greater number of patients (68.4% vs. 0%, p <0.001) required rescue analgesia in the first 24 hours.","[{'ForeName': 'Mateus Meira', 'Initials': 'MM', 'LastName': 'Vasconcelos', 'Affiliation': 'Hospital Santa Genoveva, Uberlândia, MG, Brasil.'}, {'ForeName': 'João Paulo Jordão', 'Initials': 'JPJ', 'LastName': 'Pontes', 'Affiliation': 'Hospital Santa Genoveva, Uberlândia, MG, Brasil; Sociedade Brasileira de Anestesiologia (TSA-SBA), Rio de Janeiro, RJ, Brasil; European Diploma in Anaesthesiology and Intensive Care (EDAIC), European Society of Anaesthesiology, Brussels, Belgium. Electronic address: pontes_ufu@yahoo.com.br.'}, {'ForeName': 'Alexandre de Menezes', 'Initials': 'AM', 'LastName': 'Rodrigues', 'Affiliation': 'Hospital Santa Genoveva, Uberlândia, MG, Brasil.'}, {'ForeName': 'Demócrito Ribeiro de Brito', 'Initials': 'DRB', 'LastName': 'Neto', 'Affiliation': 'Hospital Santa Genoveva, Uberlândia, MG, Brasil; Sociedade Brasileira de Anestesiologia (TSA-SBA), Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Rodrigo Rodrigues', 'Initials': 'RR', 'LastName': 'Alves', 'Affiliation': 'Hospital Santa Genoveva, Uberlândia, MG, Brasil; Sociedade Brasileira de Anestesiologia (TSA-SBA), Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Fernando Cássio do Prado', 'Initials': 'FCDP', 'LastName': 'Silva', 'Affiliation': 'Hospital Santa Genoveva, Uberlândia, MG, Brasil; Sociedade Brasileira de Anestesiologia (TSA-SBA), Rio de Janeiro, RJ, Brasil; Hospital Santa Genoveva, CET, Uberlândia, MG, Brasil.'}, {'ForeName': 'Denis Fabiano de', 'Initials': 'DF', 'LastName': 'Souza', 'Affiliation': 'Instituto do Coração do Triângulo (ICT), Uberlândia, MG, Brasil; Universidade Federal de Uberlândia (UFU), Ciências da Saúde, MG, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.07.003']
1861,33189414,"Effectiveness of the PROMUFRA program in pre-frail, community-dwelling older people: a randomized controlled trial.","This study evaluated the effect of PROMUFRA program on physical frailty, kinanthropometric, muscle function and functional performance variables in pre-frail, community-dwelling older people. Participants (n = 50, 75 ± 7 years) were randomly assigned to two groups: intervention group (IG), and control group (CG). The IG performed multi-component exercise program, focused on high-intensity resistance training (HIRT) combined with self-massage for myofascial release (SMMR) for 12 weeks (2 d.wk -1 ). Two measurements were performed, at baseline and post-3 months. Participants (n = 43) were analyzed and significant differences were found in group-time interaction for muscle mass (p = 0.017), fat mass (p = 0.003), skeletal muscle mass index (p = 0.011), maximum isometric knee extension (p = 0.042), maximum dynamic knee extension (p = 0.001), maximum leg press (p < 0.001), Barthel Index (p = 0.039) and EuroQol 5-dimensions-3-levels (p = 0.012). We conclude that PROMUFRA program is an effective training method to achieve healthy improvements for the pre-frail community.",2020,"Participants (n = 43) were analyzed and significant differences were found in group-time interaction for muscle mass (p = 0.017), fat mass (p = 0.003), skeletal muscle mass index (p = 0.011), maximum isometric knee extension (p = 0.042), maximum dynamic knee extension (p = 0.001), maximum leg press (p < 0.001), Barthel Index (p = 0.039) and EuroQol 5-dimensions-3-levels (p = 0.012).","['50, 75\xa0±\xa07 years', 'Participants (n\xa0', 'pre-frail, community-dwelling older people']","['PROMUFRA program', 'intervention group (IG), and control group (CG', 'high-intensity resistance training (HIRT) combined with self-massage']","['maximum isometric knee extension', 'maximum dynamic knee extension', 'maximum leg press', 'skeletal muscle mass index', 'Barthel Index', 'EuroQol 5-dimensions-3-levels', 'physical frailty, kinanthropometric, muscle function and functional performance variables']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",43.0,0.0435037,"Participants (n = 43) were analyzed and significant differences were found in group-time interaction for muscle mass (p = 0.017), fat mass (p = 0.003), skeletal muscle mass index (p = 0.011), maximum isometric knee extension (p = 0.042), maximum dynamic knee extension (p = 0.001), maximum leg press (p < 0.001), Barthel Index (p = 0.039) and EuroQol 5-dimensions-3-levels (p = 0.012).","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Barrachina-Igual', 'Affiliation': 'Doctoral School, Universidad Católica de Valencia San Vicente Mártir, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Martínez-Arnau', 'Affiliation': 'Department of Physiotherapy, Universitat de Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Ros', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Podiatry, Universitat de Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain; Nursing Department, Universidad Católica de Valencia San Vicente Mártir, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Flor-Rufino', 'Affiliation': 'Department of Physiotherapy, Universitat de Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanz-Requena', 'Affiliation': 'Radiology Department, Hospital Quironsalud Valencia, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Pablos', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Universidad Católica de Valencia San Vicente Mártir, C/ Ramiro de Maeztu, 14, 46900, Torrente, Valencia, Spain. Electronic address: ana.pablos@ucv.es.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.10.014']
1862,33189426,Cluster randomized controlled trial of volitional and motivational interventions to improve bowel cancer screening uptake: A population-level study.,"OBJECTIVES


Colorectal cancer (CRC) is a leading cause of cancer death worldwide, although effective uptake of bowel cancer screening is below 60% in England. This trial investigated the influence of volitional and motivational interventions and their combination on increasing guaiac fecal occult blood testing (gFOBT) screening uptake.
METHOD


In total, 34,633 participants were recruited (via North-East of England bowel cancer screening hub) into a 2×2 factorial cluster randomized controlled trial. Social norm-based motivational intervention (SNA); Implementation intention-based Volitional Help Sheet (VHS); Combined intervention (SNA+VHS); Treatment as usual control. Screening rate (gFOBT kit return rate within 8 weeks of invitation) was the primary outcome.
RESULTS


Screening kits were returned by 60% of participants (N=20,847/34,633). A substantial imbalance was observed in participant characteristics, participants in the combined intervention group were younger and more likely to be first time invitees. Adjusted analyses found insufficient evidence that any of the interventions were different to control (Combined: OR = 1.18, 95% CI 0.97-1.44; SNA alone: OR=0.93; 95% CI: 0.76-1.15; VHS alone OR= 0.88; 95% CI: 0.75-1.03). Subgroup analyses demonstrated a significant beneficial effect of the combined intervention in the youngest age group compared to control (OR = 1.27; 95% CI: 1.05-1.54).
CONCLUSIONS


The study did not support any benefit of either VHS or SNA interventions alone on bowel cancer screening uptake. The combined SNA+VHS intervention was significantly different from control only in the youngest age group in adjusted analyses. However, the magnitude of effect in the youngest age group suggests that further testing of VHS plus SNA interventions in carefully targeted populations may be warranted.",2020,"RESULTS


Screening kits were returned by 60% of participants (N=20,847/34,633).","['34,633 participants were recruited (via North-East of England bowel cancer screening hub) into a 2×2 factorial cluster randomized controlled trial', 'Colorectal cancer (CRC']","['volitional and motivational interventions', 'Social norm-based motivational intervention (SNA); Implementation intention-based Volitional Help Sheet (VHS); Combined intervention (SNA+VHS', 'VHS or SNA interventions alone']","['Screening rate (gFOBT kit return rate', 'bowel cancer screening uptake']","[{'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0346627', 'cui_str': 'Malignant tumor of intestine'}]",34633.0,0.156181,"RESULTS


Screening kits were returned by 60% of participants (N=20,847/34,633).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wilding', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK. Electronic address: S.E.Wilding@leeds.ac.uk.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Tsipa', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Branley-Bell', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK; Department of Psychology, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Darren C', 'Initials': 'DC', 'LastName': 'Greenwood', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, UK; Leeds Institute of Data Analytics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK; Centro de Investigación en Ciencias de la Salud, FCS, Universidad Anáhuac México Campus Norte, Mexico.'}, {'ForeName': 'Nahel', 'Initials': 'N', 'LastName': 'Yaziji', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Addison', 'Affiliation': 'The Bowel Cancer Screening Programme North East Hub, Gateshead Health NHS Foundation Trust, Gateshead, UK.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Kelly', 'Affiliation': 'The Bowel Cancer Screening Programme North East Hub, Gateshead Health NHS Foundation Trust, Gateshead, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Day', 'Affiliation': 'Leeds City Council, Leeds, UK; Leeds West Clinical Commissioning Group, Leeds, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Horsfall', 'Affiliation': 'NHS England and NHS Improvement (North East & Yorkshire), UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK. Electronic address: m.t.conner@leeds.ac.uk.'}, {'ForeName': 'Daryl B', 'Initials': 'DB', 'LastName': ""O'Connor"", 'Affiliation': 'School of Psychology, University of Leeds, Leeds, UK. Electronic address: d.b.oconnor@leeds.ac.uk.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113496']
1863,33189483,Perioperative nutritional prehabilitation in malnourished children with congenital heart disease: A randomized controlled trial.,"OBJECTIVE


The poor preoperative nutritional state of children with congenital heart disease (CHD) is often exacerbated postoperatively. The aim of this study was to evaluate the effect of perioperative 1- versus 2-wk nutritional prehabilitation programs on growth and surgical outcomes in malnourished children with CHD.
METHODS


Forty malnourished infants scheduled for elective CHD surgery were randomized to receive either 1 or 2 wk of a nutritional prehabilitation program. Pre- and postoperative anthropometric parameters and feeding characteristics, feeding tolerance, duration of mechanical ventilation, intensive care unit (ICU) length of stay (LOS) and total hospital LOS were documented.
RESULTS


The 2-wk prehabilitation group showed higher weight-for-age z-score and body mass index than the 1-wk group both preoperatively postnutritional, and postoperatively with significantly higher weight gain postoperatively. The 2-wk prehabilitation group had a shorter duration of postoperative mechanical ventilation, ICU LOS, and total hospital LOS.
CONCLUSION


The 2-wk prehabilitation program was associated with better anthropometric measurements, shorter ICU LOS postoperatively, and shorter duration of hospitalization and mechanical ventilation. The preoperative nutritional status of children with CHD had a negative effect on ICU LOS and duration of mechanical ventilation.",2020,"The 2-wk prehabilitation group showed higher weight-for-age z-score and body mass index than the 1-wk group both preoperatively postnutritional, and postoperatively with significantly higher weight gain postoperatively.","['children with CHD', 'malnourished children with congenital heart disease', 'Forty malnourished infants scheduled for elective CHD surgery', 'malnourished children with CHD', 'children with congenital heart disease (CHD']","['nutritional prehabilitation programs', 'Perioperative nutritional prehabilitation', 'nutritional prehabilitation program']","['shorter duration of postoperative mechanical ventilation, ICU LOS, and total hospital LOS', 'Pre- and postoperative anthropometric parameters and feeding characteristics, feeding tolerance, duration of mechanical ventilation, intensive care unit', 'anthropometric measurements, shorter ICU LOS postoperatively, and shorter duration of hospitalization and mechanical ventilation', 'higher weight-for-age z-score and body mass index', 'ICU LOS and duration of mechanical ventilation', 'growth and surgical outcomes', 'ICU) length of stay (LOS) and total hospital LOS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",40.0,0.0584061,"The 2-wk prehabilitation group showed higher weight-for-age z-score and body mass index than the 1-wk group both preoperatively postnutritional, and postoperatively with significantly higher weight gain postoperatively.","[{'ForeName': 'Mona Moustafa', 'Initials': 'MM', 'LastName': 'El-Ganzoury', 'Affiliation': 'Pediatrics Departments, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Rania A', 'Initials': 'RA', 'LastName': 'El-Farrash', 'Affiliation': 'Pediatrics Departments, Faculty of Medicine, Ain Shams University, Cairo, Egypt. Electronic address: rania.elfarrash@med.asu.edu.eg.'}, {'ForeName': 'Gihan Fouad', 'Initials': 'GF', 'LastName': 'Ahmed', 'Affiliation': 'National Nutrition Institute, Cairo, Egypt.'}, {'ForeName': 'Samah Ibrahim', 'Initials': 'SI', 'LastName': 'Hassan', 'Affiliation': 'Ministry of Health, Cairo, Egypt.'}, {'ForeName': 'Noha M', 'Initials': 'NM', 'LastName': 'Barakat', 'Affiliation': 'Pediatrics Departments, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.111027']
1864,33189606,"Corrigendum to ""Which of the branched-chain amino acids increases cerebral blood flow in hepatic encephalopathy? A double-blind randomized trial"" [Neuroimage: Clin. 19 (2008) 302-310/YNICL_1350].",,2020,,['19 (2008'],['branched-chain amino acids'],['cerebral blood flow'],[],"[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}]","[{'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",,0.531462,,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gomes Romeiro', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: fernando.romeiro@unesp.br.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'do Val Ietsugu', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'de Campos Franzoni', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Augusti', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Alvarez', 'Affiliation': 'Department of Physics and Biophysics, Botucatu Biosciences Institute, UNESP - Univ Estadual Paulista, Rua Prof. Dr. Antonio Celso Wagner Zanin, s/n, Botucatu, São Paulo 18618-689, Brazil.'}, {'ForeName': 'Lívia', 'Initials': 'L', 'LastName': 'Alves Amaral Santos', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Talles', 'Initials': 'T', 'LastName': 'Bazeia Lima', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Kátia', 'Initials': 'K', 'LastName': 'Hiromoto Koga', 'Affiliation': 'Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n, Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Sônia', 'Initials': 'S', 'LastName': 'Marta Moriguchi', 'Affiliation': 'Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n, Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Antonio Caramori', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Faria Silva', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Eduardo Gomes Garcia Betting', 'Affiliation': 'Department of Neurology, Psychology and Psychiatry, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n, Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102497']
1865,33189627,Worsening Kidney Function Is the Major Mechanism of Heart Failure in Hypertension: The ALLHAT Study.,"OBJECTIVES


The authors aimed to quantify the extent to which the effect of antihypertensive drugs on incident heart failure (HF) is mediated by their effect on kidney function.
BACKGROUND


The authors hypothesized that the dynamic change in kidney function is the mechanism behind differences in the rate of incident HF in ALLHAT trial (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) participants randomized to lisinopril and chlorthalidone, in comparison with those randomized to amlodipine and doxazosin.
METHODS


Causal mediation analysis of ALLHAT data (1994 to 2002) included participants with available baseline and 24- to 48-month estimated glomerular filtration rate (eGFR) (N = 27,918; mean age 66 ± 7.4 years; 32.4% black, 56.3% men). Change in eGFR was the mediator. Incident symptomatic HF was the primary outcome. Hospitalized/fatal HF was the secondary outcome. Linear regression (for mediator) and logistic regression (for outcome) analyses were adjusted for demographics, cardiovascular disease, and risk factors.
RESULTS


There were 1,769 incident HF events, including 1,359 hospitalized/fatal HF events. In fully adjusted causal mediation analysis, the relative change in eGFR mediated 18% of the effect of chlorthalidone, and 33% of lisinopril on incident symptomatic HF, and 25% of the effect of chlorthalidone, and 41% of lisinopril on hospitalized/fatal HF. In participants with diabetes, the relative change in eGFR mediated nearly 50% of the effect of lisinopril on incident symptomatic HF, whereas in diabetes-free participants, only 17%.
CONCLUSIONS


On the risk difference scale, change in eGFR accounts for up to 50% of the mechanism by which antihypertensive medications affect HF. (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial [ALLHAT]; NCT00000542).",2020,"In fully adjusted causal mediation analysis, the relative change in eGFR mediated 18% of the effect of chlorthalidone, and 33% of lisinopril on incident symptomatic HF, and 25% of the effect of chlorthalidone, and 41% of lisinopril on hospitalized/fatal HF.","['Causal mediation analysis of ALLHAT data (1994 to 2002) included participants with available baseline and 24- to 48-month estimated glomerular filtration rate (eGFR) (N\xa0=\xa027,918; mean age 66 ± 7.4 years; 32.4% black, 56.3% men', 'Hypertension', 'participants with diabetes']","['antihypertensive drugs', 'lisinopril', 'lisinopril and chlorthalidone', 'chlorthalidone', 'Antihypertensive and Lipid-Lowering Treatment', 'amlodipine and doxazosin']",['hospitalized/fatal HF'],"[{'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}]","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",27918.0,0.263156,"In fully adjusted causal mediation analysis, the relative change in eGFR mediated 18% of the effect of chlorthalidone, and 33% of lisinopril on incident symptomatic HF, and 25% of the effect of chlorthalidone, and 41% of lisinopril on hospitalized/fatal HF.","[{'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Khayyat-Kholghi', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'University of Texas School of Public Health, Houston, Texas.'}, {'ForeName': 'Larisa G', 'Initials': 'LG', 'LastName': 'Tereshchenko', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon. Electronic address: tereshch@ohsu.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.09.006']
1866,33189630,Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


Treatment of heart failure with reduced ejection fraction (EF) may improve patient-reported health outcomes.
OBJECTIVES


The purpose of this study was to determine timing and magnitude of change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores following initiation of sacubitril/valsartan and interaction with change in amino-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations.
METHODS


From a single-arm, open-label study of patients initiated on sacubitril/valsartan, KCCQ-23 scores and NT-proBNP were obtained at baseline and follow-up through 12 months. Cross-sectional and longitudinal analyses evaluated magnitude and rate of change in KCCQ-23 scores and associations with NT-proBNP. Patient-level data from the randomized EVALUATE-HF study were used as historic controls.
RESULTS


The analysis cohort (n = 678, age 64.7 years, 71.5% men, EF 28.9%) had a baseline KCCQ-23 overall score (OS) of 65.6. Following sacubitril/valsartan initiation, the majority (n = 412; 60.8%) of participants experienced a rise in KCCQ-23 OS ≥10 points; 26.0% increased by ≥20 points. Comparable improvement in KCCQ-23 scores was seen in various subgroups. Change in KCCQ-23 OS was inversely associated with change in circulating NT-proBNP concentrations. Among a control group of patients in EVALUATE-HF, linear rate of change in KCCQ-12 OS/14-day interval in the enalapril arm was 0.37 points (p = 0.06), whereas in the sacubitril/valsartan arm, scores increased at a rate of 1.19 points (p < 0.001), nearly identical to this dataset (1.08 points; p < 0.001).
CONCLUSIONS


Treatment of heart failure with reduced EF with sacubitril/valsartan is associated with rapid and significant improvement in KCCQ-23 scores which was significantly related to change in NT-proBNP. (Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes [PROVE-HF]; NCT02887183).",2020,Comparable improvement in KCCQ-23 scores was seen in various subgroups.,"['678, age 64.7 years, 71.5% men, EF 28.9%) had a baseline KCCQ-23 overall score (OS) of 65.6', 'From a single-arm, open-label study of patients initiated on']","['sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan, KCCQ-23 scores and NT-proBNP', 'Sacubitril/Valsartan Therapy', 'enalapril']","['KCCQ-23 scores', 'KCCQ-12 OS/14-day interval', 'circulating NT-proBNP concentrations', 'Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.141244,Comparable improvement in KCCQ-23 scores was seen in various subgroups.,"[{'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Camacho', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Nasrien E', 'Initials': 'NE', 'LastName': 'Ibrahim', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Cardiology Division, Duke University, Durham, North Carolina.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Maisel', 'Affiliation': 'Cardiology Division, University of California San Diego, San Diego, California.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Williamson', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: jjanuzzi@partners.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.09.012']
1867,33189633,Cardiovascular and Renal Outcomes of Mineralocorticoid Receptor Antagonist Use in PARAGON-HF.,"OBJECTIVES


This study sought to evaluate the efficacy and safety of sacubitril/valsartan in patients with heart failure with preserved ejection fraction (HFpEF) according to background mineralocorticoid receptor antagonist (MRA) therapy.
BACKGROUND


Current guidelines recommend consideration of MRAs in selected patients with HFpEF. This study assessed cardiovascular outcomes, renal outcomes, and safety of sacubitril/valsartan compared with valsartan in patients with HFpEF according to background MRA treatment.
METHODS


PARAGON-HF (Prospective Comparison of ARNI [angiotensin receptor -neprilysin inhibitor] with ARB [angiotensin-receptor blockers] Global Outcomes in HF with Preserved Ejection Fraction) randomized 4,796 patients with HFpEF to sacubitril/valsartan or valsartan. In a pre-specified subgroup analysis, the effect of sacubitril/valsartan versus valsartan was evaluated according to baseline MRA use on the primary study composite of total heart failure hospitalizations and cardiovascular death using semiparametric proportional rates methods, as well as the renal composite of ≥50% decrease in estimated glomerular filtration rate, development of end-stage renal disease, or death from renal causes using Cox proportional hazards regression models. Annual decline in estimated glomerular filtration rate was analyzed with repeated-measures mixed-effect models. Key safety outcomes included incidence of hypotension, hyperkalemia, and elevations in serum creatinine above predefined thresholds.
RESULTS


Patients treated with MRAs at baseline (n = 1,239, 26%), compared with MRA nonusers (n = 3,557, 74%), were younger (72 vs. 73 years), more often male (52% vs. 47%), had lower left ventricular ejection fraction (57% vs. 58%), and a higher proportion of prior HF hospitalization (59% vs. 44%) (all p < 0.001). Efficacy of sacubitril/valsartan compared with valsartan with regard to the primary cardiovascular (for MRA users: rate ratio: 0.73; 95% confidence interval [CI]: 0.56 to 0.95; vs. for MRA nonusers: rate ratio: 0.94; 95% CI: 0.79 to 1.11; p interaction  = 0.11) and renal endpoints (for MRA users: hazard ratio: 0.31; 95% CI: 0.13 to 0.76; vs. for MRA non-users: HR: 0.59; 95% CI: 0.36 to 0.95; p interaction  = 0.21) did not significantly vary by baseline MRA use. The incidence of key safety outcomes including hypotension and severe hyperkalemia (K > 6.0 mmol/l) did not vary by baseline MRA use. However, annual decline in estimated glomerular filtration rate was less with the combination of MRA and sacubitril/valsartan (for MRA users: absolute difference favoring sacubitril/valsartan: +1.2 ml/min/1.73 m 2  per year; 95% CI: 0.6 to 1.7; vs. for MRA nonusers: +0.4; 95% CI: 0.1 to 0.7; p interaction  = 0.01).
CONCLUSIONS


Clinical efficacy of sacubitril/valsartan compared with valsartan with regard to predefined cardiorenal composite outcomes in PARAGON-HF was consistent in patients treated and not treated with MRA at baseline. Addition of sacubitril/valsartan rather than valsartan alone to MRA appears to be associated with a lesser decline in renal function and no increase in severe hyperkalemia. These data support possible added value of combination treatment with sacubitril/valsartan and MRA in patients with HFpEF. (Prospective Comparison of ARNI [angiotensin receptor -neprilysin inhibitor] with ARB [angiotensin-receptor blockers] Global Outcomes in HF with Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).",2020,The incidence of key safety outcomes including hypotension and severe hyperkalemia (K > 6.0 mmol/l) did not vary by baseline MRA use.,"['4,796 patients with HFpEF to sacubitril', 'patients with HFpEF according to background MRA treatment', 'patients with heart failure with preserved ejection fraction (HFpEF) according to background mineralocorticoid receptor antagonist (MRA) therapy', 'patients with HFpEF', 'selected patients with HFpEF']","['sacubitril/valsartan', 'ARNI [angiotensin receptor -neprilysin inhibitor', 'ARB [angiotensin-receptor blockers', 'sacubitril/valsartan versus valsartan', 'valsartan', 'valsartan or valsartan', 'sacubitril/valsartan and MRA']","['lower left ventricular ejection fraction', 'renal function', 'hypotension and severe hyperkalemia', 'efficacy and safety', 'glomerular filtration rate', 'incidence of hypotension, hyperkalemia, and elevations in serum creatinine above predefined thresholds', 'severe hyperkalemia', 'renal endpoints', 'cardiovascular outcomes, renal outcomes, and safety', 'proportion of prior HF hospitalization', 'estimated glomerular filtration rate, development of end-stage renal disease, or death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4796.0,0.182514,The incidence of key safety outcomes including hypotension and severe hyperkalemia (K > 6.0 mmol/l) did not vary by baseline MRA use.,"[{'ForeName': 'Karola S', 'Initials': 'KS', 'LastName': 'Jering', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigation Clinique-Plurithématique Institut National de la Santé et de la Recherche Médicale 1433, Université de Lorraine, Nancy, France; Cardiovascular and Renal Clinical Trialists, Institut National de la Santé et de la Recherche Médicale U1116, Centre Hospitalier Régional Universitaire Nancy Brabois, Nancy, France.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Finnian R', 'Initials': 'FR', 'LastName': 'Mc Causland', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Centre d'Investigation Clinique-Plurithématique Institut National de la Santé et de la Recherche Médicale 1433, Université de Lorraine, Nancy, France; Cardiovascular and Renal Clinical Trialists, Institut National de la Santé et de la Recherche Médicale U1116, Centre Hospitalier Régional Universitaire Nancy Brabois, Nancy, France.""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Barkoudah', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'New British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: ssolomon@bwh.harvard.edu.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.014']
1868,33189635,Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2.,"OBJECTIVES


This study sought to better understand the discrepant results of 2 trials of serelaxin on acute heart failure (AHF) and short-term mortality after AHF by analyzing causes of death of patients in the RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF-2) trial.
BACKGROUND


Patients with AHF continue to suffer significant short-term mortality, but limited systematic analyses of causes of death in this patient population are available.
METHODS


Adjudicated cause of death of patients in RELAX-AHF-2, a randomized, double-blind, placebo-controlled trial of serelaxin in patients with AHF across the spectrum of ejection fraction (EF), was analyzed.
RESULTS


By 180 days of follow-up, 11.5% of patients in RELAX-AHF-2 died, primarily due to heart failure (HF) (38% of all deaths). Unlike RELAX-AHF, there was no apparent effect of treatment with serelaxin on any category of cause of death. Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients. Patients with preserved EF (≥50%) had lower rates of HF-related mortality (30% vs. 40%) but higher non-CV mortality (36% vs. 20%) compared to patients with reduced EF.
CONCLUSIONS


Despite previous data suggesting benefit of serelaxin in AHF, treatment with serelaxin was not found to improve overall mortality or have an effect on any category of cause of death in RELAX-AHF-2. Careful adjudication of events in the serelaxin trials showed that older patients and those with preserved EF had fewer deaths from HF or sudden death and more deaths from other CV causes and from noncardiac causes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778).",2020,Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients.,"['patients with AHF across the spectrum of ejection fraction (EF), was analyzed', 'Patients With Acute Heart', 'Adjudicated cause of death of patients in RELAX-AHF-2', 'Patients with AHF', 'Older patients (≥75 years']","['serelaxin', 'placebo', 'Serelaxin']","['heart failure (HF', 'acute heart failure (AHF', 'Efficacy, Safety and Tolerability', 'non-cardiovascular (CV) death', 'CV mortality', 'Cause of Death', 'rates of HF-related mortality', 'rates of mortality', 'overall mortality', 'deaths from HF or sudden death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}]",,0.323088,Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients.,"[{'ForeName': 'Rahul S', 'Initials': 'RS', 'LastName': 'Loungani', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, California.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, ASST Civil Hospitals, and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Department of Cardiology, Washington VA Medical Center, Washington, DC.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Durham, North Carolina.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Durham, North Carolina.'}, {'ForeName': 'Zubin J', 'Initials': 'ZJ', 'LastName': 'Eapen', 'Affiliation': 'Anthem Incorporated, Indianapolis, Indiana.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, University of Cyprus, Nicosia, Cyprus, and Attikon University Hospital, School of Medicine, and National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gimpelewicz', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'University of California San Diego Health, Cardiovascular Institute, La Jolla, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holbro', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Harvard Medical School, and Cardiometabolic Trials, Baim Institute for Clinical Research, Boston, Massachusetts.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Division of Cardiology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Cardiology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiology, University of Florida, Jacksonville, Florida.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address: Michael.felker@duke.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.09.010']
1869,33189747,Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic-Ischemic Encephalopathy in the Late Hypothermia Trial.,"OBJECTIVE


To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours.
STUDY DESIGN


Sub-group analysis of infants ≥ 36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by two central readers using the NICHD injury score (six levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age.
RESULTS


Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n=119) or died (n=9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted Kappa 0.56, 95% confidence interval 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively.
CONCLUSION


MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia-ischemia.",2020,The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score.,"['Sub-group analysis of infants ≥ 36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia', 'death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours', '168 enrollees']","['Conventional Magnetic Resonance Imaging', 'magnetic resonance imaging (MRI']","['death or severe disability', 'adjusted odds of death or severe disability', 'Neurodevelopmental outcomes', 'MRI injury scores', 'moderate disability', 'Death or Disability']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.330788,The adjusted odds of death or severe disability increased 3.7-fold (95% confidence interval 1.8-7.9) for each increment of injury score.,"[{'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI. Electronic address: alaptook@wihri.org.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Barnes', 'Affiliation': 'Department of Radiology and Pediatrics, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Rollins', 'Affiliation': 'Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Barbara T', 'Initials': 'BT', 'LastName': 'Do', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Nehal A', 'Initials': 'NA', 'LastName': 'Parikh', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hamrick', 'Affiliation': ""Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Ronald N', 'Initials': 'RN', 'LastName': 'Goldberg', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC.'}, {'ForeName': 'Athina', 'Initials': 'A', 'LastName': 'Pappas', 'Affiliation': 'Department of Pediatrics, Wayne State University, Detroit, MI.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Huitema', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Aasma S', 'Initials': 'AS', 'LastName': 'Chaudhary', 'Affiliation': 'Department of Pediatrics, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Angelita M', 'Initials': 'AM', 'LastName': 'Hensman', 'Affiliation': 'Department of Pediatrics, Women and Infants Hospital, Brown University, Providence, RI.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Wyckoff', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ""Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faix', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Truog', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Guillet', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Sokol', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ""Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN; Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Pregnancy and Perinatology Branch; George Mason University, Fairfax, VA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.015']
1870,33189801,Rechargeable adhesive with calcium phosphate nanoparticles inhibited long-term dentin demineralization in a biofilm-challenged environment.,"OBJECTIVES


This study aims to investigate the long-term demineralization-inhibition capability of a rechargeable adhesive with nanoparticles of amorphous calcium phosphate (NACP) on dentin in a biofilm-challenged environment.
METHODS


The NACP adhesive was immersed in a pH 4 solution to exhaust calcium (Ca) and phosphate (P) ions and then recharged with Ca and P ions. Dentin samples were demineralized underStreptococcus mutans biofilms for 24 h and randomly divided into two groups: (1) dentin control, (2) dentin with recharged NACP adhesives. Each day, all the samples were immersed in brain heart infusion broth with 1% sucrose (BHIS) for 4 h, and then in artificial saliva (AS) for 20 h. This cycle was repeated for 10 days. The pH of BHIS, the Ca and P ions content of the BHIS and AS were measured daily. After 10 days, the lactic acid production and colony-forming units of the biofilms were tested. The changes of remineralization/demineralization were also analyzed.
RESULTS


Dentin in the control group showed further demineralization. The recharged NACP adhesive neutralized acids, increasing the pH to above 5, and released large amounts of Ca and P ions each day. The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
CONCLUSIONS


The NACP adhesive could continuously inhibit dentin demineralization in a biofilm-challenged environment by recharging with Ca and P ions.
SIGNIFICANCE


The rechargeable NACP adhesive could provide long-term dentin bond protection.",2020,"The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
",[],"['amorphous calcium phosphate (NACP', 'dentin control, (2) dentin with recharged NACP adhesives', 'pH 4 solution to exhaust calcium (Ca) and phosphate (P) ions and then recharged with Ca and P ions']","['lactic acid production and colony-forming units of the biofilms', 'changes of remineralization/demineralization', 'pH of BHIS, the Ca and P ions content of the BHIS and AS', 'demineralization', 'dentin hardness', 'production of lactic acid']",[],"[{'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0022023', 'cui_str': 'Ions'}]","[{'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0188217,"The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
","[{'ForeName': 'Zhaohan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Tao', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hockin H K', 'Initials': 'HHK', 'LastName': 'Xu', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Weir', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA.'}, {'ForeName': 'Menglin', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Kunneng', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China; Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA. Electronic address: kunnengliang@163.com.'}, {'ForeName': 'Jiyao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China. Electronic address: jiyaoliscu@163.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103529']
1871,33189805,The Effect of Airway Management on CPR Quality in the Paramedic2 Randomised Controlled Trial.,"INTRODUCTION


Good quality basic life support (BLS) is associated with improved outcome from cardiac arrest. Chest compression fraction (CCF) is a BLS quality indicator, which may be influenced by the type of airway used. We aimed to assess CCF according to the airway strategy in the PARAMEDIC2 study: no advanced airway, supraglottic airway (SGA), tracheal intubation, or a combination of the two. Our hypothesis was that tracheal intubation was associated with a decrease in the CCF compared with alternative airway management strategies.
METHODS


PARAMEDIC2 was a multicentre double-blinded placebo-controlled trial of adrenaline vs placebo in out-of-hospital cardiac arrest. Data showing compression rate and ratio from patients recruited by London Ambulance Service (LAS) as part of this study was collated and analysed according to the advanced airway used during the resuscitation attempt.
RESULTS


CPR process data were available from 286/ 2058 (13.9%) of the total patients recruited by LAS. The mean compression rate for the first 5 min of data recording was the same in all groups (P = 0.272) and ranged from 104.2 (95%CI of mean: 100.5, 107.8) min -1  to 108.0 (95%CI of mean: 105.1, 108.3) min -1 . The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%. There was no difference in the compression rates and fractions across the airway management groups, regardless of the duration of CPR.
CONCLUSION


There was no significant difference in the compression fraction associated with the airway management strategy.",2020,The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%.,['out-of-hospital cardiac arrest'],"['Chest compression fraction (CCF', 'placebo', 'adrenaline vs placebo']","['mean compression rate', 'CPR Quality', 'compression fraction', 'mean compression fraction', 'compression rates and fractions']","[{'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.0676586,The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%.,"[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK; NIHR Southampton Respiratory Biomedical Research Unit, Southampton, SO16 6YD, UK. Electronic address: charlesdeakin@doctors.org.uk.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK; Royal United Hospital, Bath, BA1 3NG, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Rachael T', 'Initials': 'RT', 'LastName': 'Fothergill', 'Affiliation': ""Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK; London Ambulance Service NHS Trust, 8-20 Pocock Street, London, SE1 0BW, UK; Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK; Heartlands Hospital, University Hospitals Birmingham, Birmingham, B9 5SS, UK.'}]",Resuscitation,['10.1016/j.resuscitation.2020.11.005']
1872,33189807,Sex differences in patients with out-of-hospital cardiac arrest without ST-segment elevation: A COACT trial substudy.,"BACKGROUND


Whether sex is associated with outcomes of out-of-hospital cardiac arrest (OHCA) is unclear.
OBJECTIVES


This study examined sex differences in survival in patients with OHCA without ST-segment elevation myocardial infarction (STEMI).
METHODS


Using data from the randomized controlled Coronary Angiography after Cardiac Arrest (COACT) trial, the primary point of interest was sex differences in OHCA-related one-year survival. Secondary points of interest included the benefit of immediate coronary angiography compared to delayed angiography until after neurologic recovery, angiographic and clinical outcomes.
RESULTS


In total, 522 patients (79.1% men) were included. Overall one-year survival was 59.6% in women and 63.4% in men (HR 1.18; 95% CI: 0.76-1.81;p = 0.47). No cardiovascular risk factors were found that modified survival. Women less often had significant coronary artery disease (CAD) (37.0% vs. 71.3%;p < 0.001), but when present, they had a worse prognosis than women without CAD (HR 3.06; 95% CI 1.31-7.19;p = 0.01). This was not the case for men (HR 1.05; 95% CI 0.67-1.65;p = 0.83). In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93).
CONCLUSION


In OHCA patients without STEMI, we found no sex differences in overall one-year survival. Women less often had significant CAD, but when CAD was present they had worse survival than women without CAD. This was not the case for men. Both sexes did not benefit from a strategy of immediate coronary angiography as compared to delayed strategy with respect to one-year survival.
CLINICAL TRIAL REGISTRATION NUMBER


Netherlands trial register (NTR) 4973.",2020,"In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93).
","['patients with out-of-hospital cardiac arrest without ST-segment elevation', '522 patients (79.1% men) were included', 'patients with OHCA without ST-segment elevation myocardial infarction (STEMI']",[],"['cardiovascular risk factors', 'coronary artery disease (CAD', 'Overall one-year survival', 'delayed angiography until after neurologic recovery, angiographic and clinical outcomes', 'overall one-year survival', 'year survival', 'worse survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",522.0,0.547869,"In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93).
","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Spoormans', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands. Electronic address: j.lemkes@amsterdamumc.nl.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Lucia S D', 'Initials': 'LSD', 'LastName': 'Jewbali', 'Affiliation': 'Thorax Centre, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dubois', 'Affiliation': 'Thorax Centre, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Rijpstra', 'Affiliation': 'Department of Intensive care medicine, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Bosker', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Blans', 'Affiliation': 'Department of Intensive care medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Gabe B', 'Initials': 'GB', 'LastName': 'Bleeker', 'Affiliation': 'Department of Cardiology, HAGA Hospital, Den Haag, the Netherlands.'}, {'ForeName': 'Remon', 'Initials': 'R', 'LastName': 'Baak', 'Affiliation': 'Department of Intensive care medicine, HAGA Hospital, Den Haag, the Netherlands.'}, {'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands; Department of Cardiology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Bob J W', 'Initials': 'BJW', 'LastName': 'Eikemans', 'Affiliation': 'Department of Intensive care medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Pim van', 'Initials': 'PV', 'LastName': 'der Harst', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Cardiology, Groningen, the Netherlands; Department of Cardiology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Intensive care medicine, Groningen, the Netherlands; Department of Intensive care medicine, Maastricht University Medical Centre, University Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Intensive care medicine, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Albertus', 'Initials': 'A', 'LastName': 'Beishuizen', 'Affiliation': 'Department of Intensive care medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive care medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive care medicine, Amsterdam University Medical Centre, location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Department of Cardiology, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van den Bogaard', 'Affiliation': 'Department of Intensive care medicine, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton A C M', 'Initials': 'TACM', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord West Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'de Ruijter', 'Affiliation': 'Department of Intensive care medicine, Noord West Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'Thijs S R', 'Initials': 'TSR', 'LastName': 'Delnoij', 'Affiliation': 'Department of Intensive care medicine, Maastricht University Medical Centre, University Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Pranobe V', 'Initials': 'PV', 'LastName': 'Oemrawsingh', 'Affiliation': 'Department of Cardiology, Haaglanden Medical Centre, Den Haag, the Netherlands.'}, {'ForeName': 'Marcel T M', 'Initials': 'MTM', 'LastName': 'Gosselink', 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Magro', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive care medicine, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Resuscitation,['10.1016/j.resuscitation.2020.10.026']
1873,33189857,Combined effects of tDCS over the left DLPFC and gaze-contingent training on attention mechanisms of emotion regulation in low-resilient individuals.,"Low resilience is characterized by impairments in attention and emotion regulation mechanisms that depend on prefrontal cortical activity. The aim of this study was to test whether transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) can augment the effectiveness of a new computerized mouse-based (gaze)contingent training (MCAT) to improve attention and emotion regulation processes (improved reappraisal, reduced rumination) in individuals reporting low resilience levels. The study used a full-factorial between-subject design combining active and sham MCAT and tDCS interventions. One hundred participants reporting low resilience levels were randomly assigned to receive either a single session of: tDCS with sham MCAT treatment (tDCS group), MCAT with sham tDCS (MCAT group), a combination of tDCS and MCAT (combined group), or sham tDCS and sham MCAT (control group). Transfer to attention regulation, reappraisal success, and state rumination was evaluated using an eye-tracking disengagement task and an emotion regulation paradigm, respectively. MCAT, either alone or combined with tDCS, resulted in improved attention regulation. Furthermore, the group receiving combined MCAT and tDCS also showed some evidence of increased reappraisal ability and reduced rumination. MCAT in combination with left DLPFC neuromodulation has potential to maximize transfer to emotion regulation capacities and to promote resilience.",2020,"One hundred participants reporting low resilience levels were randomly assigned to receive either a single session of: tDCS with sham MCAT treatment (tDCS group), MCAT with sham tDCS (MCAT group), a combination of tDCS and MCAT (combined group), or sham tDCS and sham MCAT (control group).","['low-resilient individuals', 'One hundred participants reporting low resilience levels', 'individuals reporting low resilience levels']","['gaze-contingent training', 'MCAT and tDCS', 'tDCS with sham MCAT treatment (tDCS group), MCAT with sham tDCS (MCAT group), a combination of tDCS and MCAT (combined group), or sham tDCS and sham MCAT (control group', 'tDCS', 'new computerized mouse-based (gaze)contingent training (MCAT', 'MCAT', 'transcranial direct current stimulation (tDCS']","['reappraisal ability and reduced rumination', 'Transfer to attention regulation, reappraisal success, and state rumination', 'emotion regulation', 'improved attention regulation']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",100.0,0.0328545,"One hundred participants reporting low resilience levels were randomly assigned to receive either a single session of: tDCS with sham MCAT treatment (tDCS group), MCAT with sham tDCS (MCAT group), a combination of tDCS and MCAT (combined group), or sham tDCS and sham MCAT (control group).","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Sanchez-Lopez', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Personality, Evaluation and Psychological Treatment, Complutense University of Madrid, Spain. Electronic address: alvsanch@ucm.es.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Puttevils', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium.'}, {'ForeName': 'Ernst H W', 'Initials': 'EHW', 'LastName': 'Koster', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Department of Psychiatry University Hospital (UZBrussel), Brussels, Belgium; Department of Electrical Engineering, University of Technology, Eindhoven, the Netherlands.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110177']
1874,33189876,Personalized Depression Prevention: A Randomized Controlled Trial to Optimize Effects Through Risk-Informed Personalization.,"OBJECTIVE


To evaluate whether evidence-based depression prevention programs can be optimized by matching youth to interventions that address their psychosocial vulnerabilities.
METHOD


This randomized controlled trial included 204 adolescents (M = 14.26 years, SD = 1.65; 56.4% female). Youth were categorized as high or low on cognitive and interpersonal risks for depression and randomized to Coping with Stress (CWS), a cognitive-behavioral program, or Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST), an interpersonal program. Some participants received a match between risk and prevention (high cognitive-low interpersonal risk teen in CWS, low cognitive-high interpersonal risk teen in IPT-AST), others received a mismatch (e.g., low cognitive-high interpersonal risk teen in CWS). Outcomes were depression diagnoses and symptoms through 18 months post-intervention (21 months total).
RESULTS


Matched adolescents showed significantly greater decreases in depressive symptoms than mismatched adolescents from post-intervention through 18-month follow-up and across the entire 21-month study period (effect size [d] = 0.45, 95% confidence interval [CI] = .02, .87). Rates of depressive disorders among matched adolescents were lower than mismatched adolescents, but this difference fell short of statistical significance (10.1% vs. 25.2%, t(193) = -1.58, p = .12).
CONCLUSION


This study illustrates one approach to personalizing depression prevention as a form of precision mental health. Findings suggest that risk-informed personalization may enhance effects beyond a ""one size fits all"" approach.",2020,"RESULTS


Matched adolescents showed significantly greater decreases in depressive symptoms than mismatched adolescents from post-intervention through 18-month follow-up and across the entire 21-month study period (effect size [d] = 0.45, 95% confidence interval [CI] = .02, .87).","['204 adolescents (M = 14.26 years, SD = 1.65; 56.4% female']","['Personalized Depression Prevention', 'Coping with Stress (CWS), a cognitive-behavioral program, or Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST), an interpersonal program']","['Rates of depressive disorders', 'depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]","[{'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",204.0,0.140667,"RESULTS


Matched adolescents showed significantly greater decreases in depressive symptoms than mismatched adolescents from post-intervention through 18-month follow-up and across the entire 21-month study period (effect size [d] = 0.45, 95% confidence interval [CI] = .02, .87).","[{'ForeName': 'Jami F', 'Initials': 'JF', 'LastName': 'Young', 'Affiliation': ""Children's Hospital of Philadelphia, and University of Pennsylvania Perelman School of Medicine, Philadelphia. Electronic address: youngjf@email.chop.edu.""}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': ""Children's Hospital of Philadelphia, and University of Pennsylvania Perelman School of Medicine, Philadelphia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'West Chester University, Chester County, Pennsylvania.'}, {'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Benas', 'Affiliation': 'Rutgers University, New Brunswick, New Jersey.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Schueler', 'Affiliation': 'Didi Hirsch Mental Health Services, Inglewood, California.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Garber', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Hankin', 'Affiliation': 'University of Illinois, Urbana-Champaign.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.11.004']
1875,33189894,Effects of purposeful soccer heading on circulating small extracellular vesicle concentration and cargo.,"BACKGROUND


Considering the potential cumulative effects of repetitive head impact (HI) exposure, we need sensitive biomarkers to track short- and long-term effects. Circulating small extracellular vesicles (sEVs) (<200 nm) traffic biological molecules throughout the body and may have diagnostic value as biomarkers for disease. The purpose of this study was to identify the microRNA (miRNA) profile in circulating sEVs derived from human plasma following repetitive HI exposure.
METHODS


Healthy adult (ages 18-35 years) soccer players were randomly assigned to 1 of 3 groups: the HI group performed 10 standing headers, the leg impact group performed 10 soccer ball trapping maneuvers over 10 min, and the control group did not participate in any soccer drills. Plasma was collected before testing and 24 h afterward, and sEVs were isolated and characterized via nanoparticle tracking analysis. Next-generation sequencing was utilized to identify candidate microRNAs isolated from sEVs, and candidate microRNAs were analyzed via quantitative polymerase chain reaction. In silico target prediction was performed using TargetScan and miRWalk programs, and target validation was performed using luciferase reporter vectors with a miR-7844-5p mimic in HEK293 cells.
RESULTS


Plasma sEV concentration and size were not affected across time and group following repetitive HI exposure. After 24 h, the HI read count from next-generation sequencing showed a 4-fold or greater increase in miR-92b-5p, miR-423-5p, and miR-24-3p and a 3-fold or greater decrease in miR-7844-5p, miR-144-5p, miR-221-5p, and miR-22-3p. Analysis of quantitative polymerase chain reaction revealed that leg impact did not alter the candidate miRNA levels. To our knowledge, miR-7844-5p is a previously unknown miRNA. We identified 8 miR-7844-5p mRNA targets: PPP1R1B, LIMS1, ATG12, MAP1LC3B, ITGA1, MAPK1, GSK3B, and MAPK8.
CONCLUSION


Collectively, these data indicate repetitive HI exposure alters plasma sEV miRNA content, but not sEV size or number. Furthermore, for the first time we demonstrate that previously unknown miR-7844-5p targets mRNAs known to be involved in mitochondrial apoptosis, autophagy regulation, mood disorders, and neurodegenerative disease.",2020,"We identified 8 miR-7844-5p mRNA targets: PPP1R1B, LIMS1, ATG12, MAP1LC3B, ITGA1, MAPK1, GSK3B, and MAPK8.
CONCLUSION


","['Healthy adult (age 18-35 years', 'soccer players']","['head impact (HI) group performed 10 standing headers, the leg impact (LI) group performed 10 soccer ball trapping maneuvers over 10 min, and the control (CON) group did not participate in any soccer drills', 'purposeful soccer heading']",['Plasma sEV concentration and size'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0336986', 'cui_str': 'Soccer ball'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0801417,"We identified 8 miR-7844-5p mRNA targets: PPP1R1B, LIMS1, ATG12, MAP1LC3B, ITGA1, MAPK1, GSK3B, and MAPK8.
CONCLUSION


","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Muñoz', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 540 South College Avenue, Newark, DE 19713, USA.'}, {'ForeName': 'Jaclyn B', 'Initials': 'JB', 'LastName': 'Caccese', 'Affiliation': 'The Ohio State University College of Medicine, School of Health and Rehabilitation Sciences, 453 W, 10th Avenue, Columbus, OH 43210, USA.'}, {'ForeName': 'Brittany E', 'Initials': 'BE', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 540 South College Avenue, Newark, DE 19713, USA.'}, {'ForeName': 'Kyle T', 'Initials': 'KT', 'LastName': 'Shuler', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 540 South College Avenue, Newark, DE 19713, USA.'}, {'ForeName': 'Fernando V', 'Initials': 'FV', 'LastName': 'Santos', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 540 South College Avenue, Newark, DE 19713, USA.'}, {'ForeName': 'Carolina T', 'Initials': 'CT', 'LastName': 'Cabán', 'Affiliation': 'Department of Neuroscience, Lewis Katz School of Medicine, Temple University, 3500 North Broad Street, Philadelphia, PA 19140, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jeka', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 540 South College Avenue, Newark, DE 19713, USA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Langford', 'Affiliation': 'Department of Neuroscience, Lewis Katz School of Medicine, Temple University, 3500 North Broad Street, Philadelphia, PA 19140, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Hudson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, 540 South College Avenue, Newark, DE 19713, USA. Electronic address: mbhudson@udel.edu.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.11.006']
1876,33189900,Investigating the effect of TRPV4 inhibition on pulmonary-vascular barrier permeability following segmental endotoxin challenge.,"BACKGROUND


Acute Respiratory Distress Syndrome (ARDS) is associated with increased pulmonary-vascular permeability. In the lung, transient receptor potential vanilloid 4 (TRPV4), a Ca 2+ -permeable cation channel, is a regulator of endothelial permeability and pulmonary edema. We performed a Phase I, placebo-controlled, double-blind, randomized, parallel group, proof-of-mechanism study to investigate the effects of TRPV4 channel blocker, GSK2798745, on pulmonary-vascular barrier permeability using a model of lipopolysaccharide (LPS)-induced lung inflammation.
METHODS


Healthy participants were randomized 1:1 to receive 2 single doses of GSK2798745 or placebo, 12 hours apart. Two hours after the first dose, participants underwent bronchoscopy and segmental LPS instillation. Total protein concentration and neutrophil counts were measured in bronchoalveolar lavage (BAL) samples collected before and 24 hours after LPS challenge, as markers of barrier permeability and inflammation, respectively. The primary endpoint was baseline adjusted total protein concentration in BAL at 24 hours after LPS challenge. A Bayesian framework was used to estimate the posterior probability of any percentage reduction (GSK2798745 relative to placebo). Safety endpoints included the incidence of adverse events (AEs), vital signs, 12-lead electrocardiogram, clinical laboratory and haematological evaluations, and spirometry.
RESULTS


Forty-seven participants were dosed and 45 completed the study (22 on GSK2798745 and 23 on placebo). Overall, GSK2798745 was well tolerated. Small reductions in mean baseline adjusted BAL total protein (∼9%) and neutrophils (∼7%) in the LPS-challenged segment were observed in the GSK2798745 group compared with the placebo group; however, the reductions did not meet pre-specified success criteria of at least a 95% posterior probability that the percentage reduction in the mean 24-hours post LPS BAL total protein level (GSK2798745 relative to placebo) exceeded zero. Median plasma concentrations of GSK2798745 were predicted to inhibit TRPV4 on lung vascular endothelial cells by ∼70-85% during the 24 hours after LPS challenge; median urea-corrected BAL concentrations of GSK2798745 were 3.0- to 8.7-fold higher than those in plasma.
CONCLUSIONS


GSK2798745 did not affect segmental LPS-induced elevation of BAL total protein or neutrophils, despite blood and lung exposures that were predicted to be efficacious. CLINICALTRIALS.
GOV IDENTIFIER


NCT03511105.",2020,"Small reductions in mean baseline adjusted BAL total protein (∼9%) and neutrophils (∼7%) in the LPS-challenged segment were observed in the GSK2798745 group compared with the placebo group; however, the reductions did not meet pre-specified success criteria of at least a 95% posterior probability that the percentage reduction in the mean 24-hours post LPS BAL total protein level (GSK2798745 relative to placebo) exceeded zero.","['Forty-seven participants were dosed and 45 completed the study (22 on GSK2798745 and 23 on', 'Healthy participants', 'Acute Respiratory Distress Syndrome (ARDS']","['bronchoscopy and segmental LPS instillation', 'placebo', 'TRPV4 channel blocker, GSK2798745', 'TRPV4 inhibition', 'GSK2798745 or placebo']","['Total protein concentration and neutrophil counts', 'segmental LPS-induced elevation of BAL total protein or neutrophils, despite blood and lung exposures', 'mean 24-hours post LPS BAL total protein level', 'tolerated', 'Median plasma concentrations', 'baseline adjusted total protein concentration in BAL', 'lung vascular endothelial cells', 'mean baseline adjusted BAL total protein (∼9%) and neutrophils', 'incidence of adverse events (AEs), vital signs, 12-lead electrocardiogram, clinical laboratory and haematological evaluations, and spirometry']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}]","[{'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1257792', 'cui_str': 'Vascular Endothelial Cells'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",47.0,0.377141,"Small reductions in mean baseline adjusted BAL total protein (∼9%) and neutrophils (∼7%) in the LPS-challenged segment were observed in the GSK2798745 group compared with the placebo group; however, the reductions did not meet pre-specified success criteria of at least a 95% posterior probability that the percentage reduction in the mean 24-hours post LPS BAL total protein level (GSK2798745 relative to placebo) exceeded zero.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mole', 'Affiliation': 'GlaxoSmithKline, Gunnells Wood Road, Stevenage, UK. Electronic address: sarah.x.mole@GSK.com.'}, {'ForeName': 'Anya', 'Initials': 'A', 'LastName': 'Harry', 'Affiliation': 'GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': 'GlaxoSmithKline, Stockley Park, West Uxbridge, Middlesex, UB11 1BT, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hotee', 'Affiliation': 'GlaxoSmithKline, Gunnells Wood Road, Stevenage, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Warburton', 'Affiliation': 'GlaxoSmithKline, Gunnells Wood Road, Stevenage, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Waite', 'Affiliation': 'GlaxoSmithKline, Stockley Park, West Uxbridge, Middlesex, UB11 1BT, UK.'}, {'ForeName': 'Misba', 'Initials': 'M', 'LastName': 'Beerahee', 'Affiliation': 'GlaxoSmithKline, Gunnells Wood Road, Stevenage, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Behm', 'Affiliation': 'GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Badorrek', 'Affiliation': 'Fraunhofer-Institut Fuer Toxikologie und Experimentelle Medizin [ITEM], Nikolai-Fuchs-Straße 1, 30625, Hannover, Germany.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Fraunhofer-Institut Fuer Toxikologie und Experimentelle Medizin [ITEM], Nikolai-Fuchs-Straße 1, 30625, Hannover, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Faulenbach', 'Affiliation': 'Fraunhofer-Institut Fuer Toxikologie und Experimentelle Medizin [ITEM], Nikolai-Fuchs-Straße 1, 30625, Hannover, Germany.'}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': 'GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA, 19426, USA.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Fraunhofer-Institut Fuer Toxikologie und Experimentelle Medizin [ITEM], Nikolai-Fuchs-Straße 1, 30625, Hannover, Germany; Hannover Medical School and German Centre for Lung Research, Medizinische Hochschule Hannover OE6876, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101977']
1877,33189909,Does prophylactic use of topical gelatin-thrombin matrix sealant affect postoperative drainage volume and hematoma formation following microendoscopic spine surgery?: a randomized controlled trial.,"BACKGROUND CONTEXT


Microendoscopic spinal surgery has demonstrated efficacy and is increasingly utilized as a minimally invasive approach to neural decompression, but there is a theoretical concern that bleeding and postoperative epidural hematoma (PEH) may occur with increased frequency in a contained small surgical field. Hemostatic agents, such as topical gelatin-thrombin matrix sealant (TGTMS), are routinely used in spine surgery procedures, yet there has been no data on whether PEH is suppressed by these agents when administered in microendoscopic spine surgery.
PURPOSE


The purpose of this study was to investigate the effect of TGTMS on bleeding and PEH formation in lumbar micoroendoscopic surgery.
STUDY DESIGN


This is a randomized controlled trial (RCT) with additional prospective observational cohort.
PATIENT SAMPLE


Patients were registered from July 2017 to September 2018 and a hundred and three patients undergoing microendoscopic laminectomy for lumbar spinal stenosis at a single institution were enrolled in this study.
OUTCOME MEASURES


The primary outcome was the drainage volume within 48 hours after surgery. Secondary outcomes were the numerical rating scale (NRS) of leg pain on the second (NRS2) and seventh day (NRS7) after surgery and the hematoma area ratio (HAR) in horizontal images on magnetic resonance image (MRI).
METHODS


In the RCT, 41 cases that received TGTMS (F group) were compared with 41 control group cases (C group) that did not receive TGTMS at the end of the procedure. Drainage volume, NRS2, NRS7, and HAR on MRI were evaluated. Nineteen cases were excluded from the RCT (I group) due to difficulty of hemostasis during surgery and the intentional use of TGTMS for hemostasis. I group was compared with C group in the drainage volume and NRS of leg pain as a prospective observational study.
RESULTS


The RCT demonstrated no statistically significant difference in drainage volume between those receiving TGTMS (117.0±71.7; mean±standard deviation) and controls (125.0±127.0) (p=0.345). The NRS2 and NRS7 was 3.5±2.6 and 2.8±2.5 in the F group, respectively, and 3.1±2.6 and 2.1±2.3 in the C group, respectively. The HAR on MRI was 0.19±0.19 in the F group and 0.17±0.13 in the C group. There was no significant difference in postoperative leg pain and HAR (p=0.644 for NRS2, p=0.129 for NRS7, and p=0.705 for HAR). In the secondary observational cohort, the drainage volume in the I group was 118.3±151.4, and NRS2 and NRS7 was 3.5±2.0 and 2.6±2.6, respectively. There were no statistically significant differences in drainage volume (p=0.386) or postoperative NRS of leg pain between these two groups (p=0.981 and 0.477 for NRS2 and NRS7, respectively).
CONCLUSIONS


The prophylactic use of TGTMS in patients undergoing microendoscopic laminotomy for lumbar spinal stenosis did not demonstrate any difference in postoperative bleeding or PEH. Nonetheless, for patients that had active bleeding that required the use of TGTMS, there was no evidence of difference in postoperative clinical outcomes relative to controls.",2020,"There were no statistically significant differences in drainage volume (p=0.386) or postoperative NRS of leg pain between these two groups (p=0.981 and 0.477 for NRS2 and NRS7, respectively).
","['patients undergoing microendoscopic laminotomy for lumbar spinal stenosis', 'Nineteen cases were excluded from the RCT (I group) due to difficulty of hemostasis during surgery and the intentional use of TGTMS for hemostasis', 'SAMPLE\n\n\nPatients were registered from July 2017 to September 2018 and a hundred and three patients undergoing', 'for lumbar spinal stenosis at a single institution were enrolled in this study', 'lumbar micoroendoscopic surgery']","['topical gelatin-thrombin matrix sealant', 'microendoscopic laminectomy', 'TGTMS', 'topical gelatin-thrombin matrix sealant (TGTMS']","['postoperative NRS of leg pain', 'numerical rating scale (NRS) of leg pain on the second (NRS2) and seventh day (NRS7) after surgery and the hematoma area ratio (HAR) in horizontal images on magnetic resonance image (MRI', 'NRS2 and NRS7', 'Drainage volume, NRS2, NRS7, and HAR on MRI', 'drainage volume', 'postoperative bleeding or PEH', 'HAR on MRI', 'bleeding and PEH formation', 'postoperative drainage volume and hematoma formation', 'postoperative leg pain and HAR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0238154', 'cui_str': 'Epidural hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",19.0,0.104434,"There were no statistically significant differences in drainage volume (p=0.386) or postoperative NRS of leg pain between these two groups (p=0.981 and 0.477 for NRS2 and NRS7, respectively).
","[{'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Takami', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008. Electronic address: takami@wakayama-med.ac.jp.'}, {'ForeName': 'Munehito', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Minamide', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hashizume', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Yasutsugu', 'Initials': 'Y', 'LastName': 'Yukawa', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Spine Care Center, Wakayama Medical University Kihoku Hospital, 219 Myoji, Katsuragi-cho, Wakayama, Japan, postal code: 649-7113, tel: +81 (0)736 22 0066, fax: +81 (0)736 22 2579.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Taiji', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Nishi', 'Affiliation': 'Department of Orthopaedic Surgery, Hidaka Hospital, 116-2 Sono, Gobo-city, Wakayama, Japan, postal code: 644-0002, tel: +81 (0)738 22 1111, fax: +81 (0)738 22 7140.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Schoenfeld', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Simpson', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Department of Orthopaedic Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama, Japan, postal code: 641-8510, tel: +81 (0)73 441 0645, fax: +81 (0)73 448 3008.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.11.004']
1878,33189951,Memory improvement in aging as a function of exposure to mood-matching music.,"This study examined the effect of matching musical emotion and the mood of the listener on working memory and free recall in normal aging. Memory measures were taken at baseline in healthy young and older participants, and, following a happy or sad mood induction, again after exposure to both mood-matching and -mismatching music in a counterbalanced repeated measures design. Compared to baseline, [i] recall was greater following mood-matching than mood-mismatching music in both groups, and was reduced following mood-mismatching music in older adults, [ii] working memory was greater in the mood-matching condition, but did not differ from baseline in the mismatching condition. The results have significant implications for the increasingly popular forms of intervention involving music used with older populations experiencing cognitive decline.",2020,"Compared to baseline, [i] recall was greater following mood-matching than mood-mismatching music in both groups, and was reduced following mood-mismatching music in older adults, [ii] working memory was greater in the mood-matching condition, but did not differ from baseline in the mismatching condition.","['healthy young and older participants', 'normal aging']",['matching musical emotion'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",[],,0.0577816,"Compared to baseline, [i] recall was greater following mood-matching than mood-mismatching music in both groups, and was reduced following mood-mismatching music in older adults, [ii] working memory was greater in the mood-matching condition, but did not differ from baseline in the mismatching condition.","[{'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Ward', 'Affiliation': 'Middlesex University, London, UK. Electronic address: E.ward@mdx.ac.uk.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Isac', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Van Puyvelde', 'Affiliation': 'Royal Military Academy, Brussels, Belgium; Vrije Universitei Brussel, Brussels, Belgium.'}, {'ForeName': 'Fabia', 'Initials': 'F', 'LastName': 'Franco', 'Affiliation': 'Middlesex University, London, UK.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103206']
1879,33190008,The effects of sumac (Rhus coriaria L.) powder supplementation in patients with non-alcoholic fatty liver disease: A randomized controlled trial.,"BACKGROUND


In recent years, great attention has been paid to the role of herbal medicine in the management of non-alcoholic fatty liver disease (NAFLD). Sumac (Rhus coriaria L.) is a popular herb which contains major bioactive compounds known for a variety of health benefits. This study aimed to assess the effects of sumac powder supplementation on hepatic fibrosis and some metabolic markers in patients with NAFLD.
METHODS


Eighty-four patients diagnosed with NAFLD were included in this randomized double-blind placebo-controlled clinical trial. They were randomly assigned to receive 2000 mg per day sumac powder (n = 42) or placebo (n = 42) for 12 weeks. Also, both groups received a 500-calories deficit diet plan. Hepatic fibrosis and liver enzymes (ALT and AST) as well as fasting blood sugar (FBS), serum insulin, HbA1c, HOMA-IR (insulin resistance index), QUICKI (insulin sensitivity index), malondialdehyde (MDA), and high sensitivity C-reactive protein (hs-CRP) were measured at baseline and the end of trial.
RESULTS


Eighty patients completed the trial. After 12-weeks of intervention, subjects in the sumac group showed a greater decrease in hepatic fibrosis and liver enzymes as well as FBS, serum insulin, HbA1c, HOMA-IR, MDA, and hs-CRP, compared to the placebo (P-value < 0.05); while the QUICKI was significantly higher in the sumac group at the end of intervention.
CONCLUSION


Daily intake of 2000 mg sumac powder along with a low-calorie diet for 12 weeks was beneficial for the management of NAFLD.",2020,"After 12-weeks of intervention, subjects in the sumac group showed a greater decrease in hepatic fibrosis and liver enzymes as well as FBS, serum insulin, HbA1c, HOMA-IR, MDA, and hs-CRP, compared to the placebo (P-value < 0.05); while the QUICKI was significantly higher in the sumac group at the end of intervention.
","['patients with NAFLD', 'Eighty-four patients diagnosed with NAFLD', 'Eighty patients completed the trial', 'patients with non-alcoholic fatty liver disease']","['500-calories deficit diet plan', 'placebo', 'sumac (Rhus coriaria L.) powder supplementation', 'sumac powder supplementation']","['hepatic fibrosis and liver enzymes', 'fasting blood sugar (FBS), serum insulin, HbA1c, HOMA-IR (insulin resistance index), QUICKI (insulin sensitivity index), malondialdehyde (MDA), and high sensitivity C-reactive protein (hs-CRP', 'QUICKI', 'FBS, serum insulin, HbA1c, HOMA-IR, MDA, and hs-CRP', 'Hepatic fibrosis and liver enzymes (ALT and AST', 'hepatic fibrosis and some metabolic markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0330866', 'cui_str': 'Coriaria'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}]",84.0,0.374658,"After 12-weeks of intervention, subjects in the sumac group showed a greater decrease in hepatic fibrosis and liver enzymes as well as FBS, serum insulin, HbA1c, HOMA-IR, MDA, and hs-CRP, compared to the placebo (P-value < 0.05); while the QUICKI was significantly higher in the sumac group at the end of intervention.
","[{'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Kazemi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shidfar.f@iums.ac.ir.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Ehsani', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Adibi', 'Affiliation': 'Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Eslami', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101259']
1880,33190009,Electromoxibustion for knee osteoarthritis in older adults: A pilot randomized controlled trial.,"BACKGROUND


Electromoxibustion devices are commercially available and can be self-administered by patients. Nevertheless, little is known about the effectiveness and potential burn injury of these devices as this topic is under-investigated.
OBJECTIVE


To assess the preliminary effects and safety of an electromoxibustion (EM) device for improving knee pain and joint functions in older adults with knee osteoarthritis (KOA).
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION


This was a pilot two-armed assessor-blinded randomized controlled trial to assess the effects of electromoxibustion (EM) on older adults with KOA. A total of 38 subjects aged 60 or above, with KOA for 3 months or above were recruited. Participants were randomized to the EM group or the knee health education group. The intervention group (n = 21) received 12 sessions of EM spanning across four weeks, while the control group (n = 17) received two sessions of knee health education.
MAIN OUTCOME MEASURES


Primary outcome included the pain severity Numerical Rating Scale (NRS) at baseline and week 4. Secondary outcomes included the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Short-Form Six-Dimension (SF6D), Timed Up & Go Test (TUG) and Fast Speed Gait (FSG).
RESULTS


Both groups showed a decreasing trend in knee pain intensity by NRS at post-intervention. There were also trends of improvement in the WOMAC score, TUG score, FGS test score and SF-6D score at week 4. Only a small between-group effect size (d = 0.13) was found, but medium between-group effects sizes were found in the WOMAC total score (d = 0.40) and WOMAC functional sub-score (d = 0.51). However, the differences were not statistically significant.
CONCLUSION


This study suggested that EM may be beneficial for KOA in older adults, particularly in terms of improving knee function. Replication of similar studies in larger RCTs is warranted to confirm the effectiveness of EM on reducing pain and knee function of older adults with KOA.
TRAIL REGISTRATION NUMBER


NCT04034394.",2020,"There were also trends of improvement in the WOMAC score, TUG score, FGS test score and SF-6D score at week 4.","['older adults', '38 subjects aged 60 or above, with KOA for 3 months or above were recruited', 'older adults with KOA', 'older adults with knee osteoarthritis (KOA']","['electromoxibustion (EM', 'Electromoxibustion', 'electromoxibustion (EM) device', 'knee health education', 'knee health education group', 'EM']","['pain severity Numerical Rating Scale (NRS', 'WOMAC functional sub-score', 'pain and knee function', 'knee pain intensity', 'WOMAC total score', 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Short-Form Six-Dimension (SF6D), Timed Up & Go Test (TUG) and Fast Speed Gait (FSG', 'knee pain and joint functions', 'WOMAC score, TUG score, FGS test score and SF-6D score']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0220769', 'cui_str': 'FG syndrome'}]",38.0,0.172914,"There were also trends of improvement in the WOMAC score, TUG score, FGS test score and SF-6D score at week 4.","[{'ForeName': 'Teris', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: teris.cheung@polyu.edu.hk.'}, {'ForeName': 'Yuen Shan', 'Initials': 'YS', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: Janice.ys.ho@polyu.edu.hk.'}, {'ForeName': 'Chun-Sum', 'Initials': 'CS', 'LastName': 'Yuen', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. Electronic address: 19481969@life.hkbu.edu.hk.'}, {'ForeName': 'Chun-Sing', 'Initials': 'CS', 'LastName': 'Lam', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: chun-sing-jason.lam@polyu.edu.hk.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Chun-Lung So', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: billy.so@polyu.edu.hk.'}, {'ForeName': 'Shu-Cheng', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: shuncheng.chen@connect.polyu.hk.'}, {'ForeName': 'Doris Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: doris.yp.leung@polyu.edu.hk.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Kwai-Ping Suen', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: lorna.suen@polyu.edu.hk.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Tin-Yau So', 'Affiliation': 'Yan Chai Hospital Social Services Department, Yan Chai Hospital, Hong Kong SAR, China. Electronic address: larryso@hq.ychss.org.hk.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chun-Hei Ho', 'Affiliation': 'Yan Chai Hospital Social Services Department, Yan Chai Hospital, Hong Kong SAR, China. Electronic address: alexho@hq.ychss.org.gk.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China. Electronic address: jerry-wf.yeung@polyu.edu.hk.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101254']
1881,33190032,"Investigation of the effect of the dual orexin receptor antagonist almorexant on ophthalmological, spermatogenic, and hormonal variables in healthy male subjects.","BACKGROUND/AIMS


The aim of this single-center, double-blind study was to investigate the effect of a 4-week once daily administration of 200 mg almorexant on tear film break-up time, spermatogenesis, hormone levels, and pancreatic elastase in stool in healthy male subjects.
METHODS


Almorexant 200 mg or matching placebo was administered in the evening for 4 weeks once daily to 56 healthy male subjects. Changes in ophthalmological variables, sperm composition, hormone levels, and pancreatic elastase levels in stool were evaluated periodically up to 8 weeks after discontinuation of drug administration. Blood samples for pharmacokinetic measurements were taken after 4 weeks to confirm compliance to study drug intake.
RESULTS


The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study. Furthermore, spermatogenesis, hormones of the hypothalamic-pituitary-adrenal and -gonadal axes, and endocrine pancreatic secretion were shown to be not affected by a 4-week once daily administration of almorexant.
CONCLUSION


Almorexant was well tolerated and had no effect on the spectrum of pharmacodynamic variables assessed. Ophthalmology and testicular findings detected in preclinical studies were not observed in this clinical study. Therefore, these preclinical findings appear not to be relevant for humans and do not prevent from conducting larger clinical trials with either healthy subjects or patients.",2020,"The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study.","['56 healthy male subjects', 'healthy male subjects', 'healthy subjects or patients']","['dual orexin receptor antagonist almorexant', '200 mg almorexant', 'Almorexant 200 mg or matching placebo']","['ophthalmological variables, sperm composition, hormone levels, and pancreatic elastase levels', 'Furthermore, spermatogenesis, hormones of the hypothalamic-pituitary-adrenal and -gonadal axes, and endocrine pancreatic secretion', 'ophthalmological, spermatogenic, and hormonal variables', 'tear film break-up time, spermatogenesis, hormone levels, and pancreatic elastase']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}, {'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037864', 'cui_str': 'Spermatogenesis'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0018067', 'cui_str': 'Gonadal structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0030296', 'cui_str': 'Pancreatic fluid'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}]",56.0,0.129217,"The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study.","[{'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Clinical Pharmacology, Allschwil Switzerland. Electronic address: jasper.dingemanse@idorsia.com.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Charef', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Clinical Science, Allschwil, Switzerland.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Stanford Center for Sleep Science and Medicine, Palo Alto, California, United States; Neuropharma, Inc., Park City, Utah, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gouws', 'Affiliation': 'Pasteur Medical Centre, Bloemfontein, South Africa.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110955']
1882,33190085,Patient experiences of as-needed budesonide-formoterol by Turbuhaler® for treatment of mild asthma; a qualitative study.,"BACKGROUND


Combination low-dose budesonide-formoterol, taken as-needed for symptom relief reduces exacerbation risk and is recommended for treatment of mild asthma. The NovelQ qualitative study explored patients' attitudes toward using this novel therapy.
METHODS


Adults with mild asthma using reliever-only treatment were randomised to as-needed budesonide-formoterol Turbuhaler® in a multinational, 52-week open-label randomised controlled trial (NovelSTART-ACTRN12615000999538). A subgroup were interviewed to explore their attitudes to use of as-needed budesonide-formoterol after receiving it for ≥10 months. Semi-structured interviews were conducted until saturation, audio-recorded, and thematically analysed.
RESULTS


Analysis of 35 participants (66% female; mean age 43.5 [range 18-74]; mean Asthma Control Questionnaire score 1.09 ± SD0.55) interviews identified 5 themes, each including both barriers and facilitators to therapy use. Themes were: 'Treatment effectiveness' i.e. how well symptoms were relieved and/or prevented; 'Lifestyle fit of the regimen' e.g. the extent to which the treatment regimen integrated into the patient's daily life; 'Attitudes toward medication use and safety' e.g. openness for new reliever treatments, beliefs about treatment necessity or side effects; 'Device attributes' e.g. perceived ease of use; and 'Doctor-patient relationship' e.g. impact of health professional support on new treatment acceptance.
CONCLUSIONS


A wide range of factors seem to drive the opinions of mild asthma patients on as-needed budesonide-formoterol therapy. Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study. Supportive patient-physician interactions appear key to addressing patient barriers. Recommendations for patient-centred discussions, developed from this research, are provided.",2020,"Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study.","['mild asthma', '35 participants (66% female; mean age 43.5 [range 18-74', 'Adults with mild asthma using reliever-only treatment']","['budesonide-formoterol', 'budesonide-formoterol Turbuhaler®', 'budesonide-formoterol by Turbuhaler®']",['mean Asthma Control Questionnaire score'],"[{'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706265', 'cui_str': 'Asthma Control Questionnaire score'}]",,0.0311362,"Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Foster', 'Affiliation': 'Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. Electronic address: j.m.foster@woolcock.org.au.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: richard.beasley@mrinz.ac.nz.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: Irene.Braithwaite@mrinz.ac.nz.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham Respiratory Medicine Unit and NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK. Electronic address: tim.harrison@nottingham.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: Mark.Holliday@mrinz.ac.nz.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit, Oxford Respiratory NIHR Biomedical Research Centre, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. Electronic address: helen.reddel@sydney.edu.au.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106154']
1883,33180963,Botulinum toxin type A therapy for cervical dystonia.,"BACKGROUND


This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia, and is a highly disabling movement disorder, characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition.
OBJECTIVES


To compare the efficacy, safety, and tolerability of BtA versus placebo, in people with cervical dystonia.
SEARCH METHODS


We searched Cochrane Movement Disorders' Trials Register, CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. All elements of the search, with no language restrictions, were last run in July 2020.
SELECTION CRITERIA


Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with cervical dystonia.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third review author. We performed meta-analyses using a random-effects model, for the comparison of BtA versus placebo, to estimate pooled effects and corresponding 95% confidence intervals (95% CI). We performed preplanned subgroup analyses according to BtA dose used, the BtA formulation used, and the use (or not) of guidance for BtA injections. The primary efficacy outcome was improvement in cervical dystonia-specific impairment. The primary safety outcome was the proportion of participants with any adverse event.
MAIN RESULTS


We included nine RCTs, with moderate, overall risk of bias, that included 1144 participants with cervical dystonia. Seven studies excluded participants with poorer responses to BtA treatment, therefore, including an enriched population with a higher probability of benefiting from this therapy. Only one trial was independently funded. All RCTs evaluated the effect of a single BtA treatment session, using doses from 150 U to 500 U of onabotulinumtoxinA (Botox), 120 U to 240 U of incobotulinumtoxinA (Xeomin), and 250 U to 1000 U of abobotulinumtoxinA (Dysport). BtA resulted in a moderate to large improvement from the participant's baseline clinical status, assessed by the investigators, with a mean reduction of 8.09 points in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS total score) at week four after injection (95% CI 6.22 to 9.96; I² = 0%) compared to placebo. This corresponded, on average, to a 18.4% improvement from baseline. The mean difference (MD) in TWSTRS pain subscore at week four was 2.11 (95% CI 1.38 to 2.83; I² = 0%) compared to placebo. Overall, both participants and clinicians reported an improvement of subjective clinical status. It was unclear if dropouts due to adverse events differed (risk ratio (RR) 2.51; 95% CI 0.42 to 14.94; I² = 0%) However, BtA treatment increased the risk of experiencing an adverse event (R) 1.23; 95% CI 1.05 to 1.43; I² = 28%). Neck weakness (14%; RR 3.40; 95% CI 1.19 to 9.71; I² = 15%), dysphagia (11%; RR 3.19; 95% CI 1.79 to 5.70; I² = 0%), and diffuse weakness or tiredness (8%; RR 1.80; 95% CI 1.10 to 2.95; I² = 0%) were the most common treatment-related adverse events. Treatment with BtA resulted in a decreased risk of dropouts. We have moderate certainty in the evidence across all of the aforementioned outcomes, with the exception of subjective assessment and tolerability, in which we have high confidence in the evidence. We found no evidence supporting the existence of a clear dose-response relationship between BtA and improvement in cervical dystonia-specific impairment, a destinction between BtA formulations, or a variation with use of EMG-guided injection for efficacy outcomes. Due to clinical heterogeneity, we did not pool health-related quality of life data, duration of clinical effect, or the development of secondary non-responsiveness.
AUTHORS' CONCLUSIONS


We are moderately certain in the evidence that a single BtA treatment session resulted in a clinically relevant reduction of cervical dystonia-specific impairment, and pain, and highly certain that it is well tolerated, compared with placebo. There is moderate-certainty evidence that people treated with BtA are at an increased risk of developing adverse events, most notably, dysphagia, neckweakness and diffuse weakness or tiredness. There are no data from RCTs evaluating the effectiveness and safety of repeated BtA injection cycles. There is no evidence from RCTs to allow us to draw definitive conclusions on the optimal treatment intervals and doses, the usefulness of guidance techniques for injection, the impact on quality of life, or the duration of treatment effect.",2020,"We found no evidence supporting the existence of a clear dose-response relationship between BtA and improvement in cervical dystonia-specific impairment, a destinction between BtA formulations, or a variation with use of EMG-guided injection for efficacy outcomes.","['adults with cervical dystonia', 'cervical dystonia', 'people with cervical dystonia', '1144 participants with cervical dystonia']","['abobotulinumtoxinA', 'incobotulinumtoxinA', 'placebo', 'botulinum toxin type A (BtA', 'Botulinum toxin type A therapy']","['efficacy, safety, and tolerability', 'Neck weakness', 'cervical dystonia-specific impairment', 'proportion of participants with any adverse event', 'risk of experiencing an adverse event', 'diffuse weakness or tiredness', 'risk of dropouts', 'cervical dystonia-specific impairment, and pain', 'subjective clinical status', 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS total score', 'mean difference (MD) in TWSTRS pain subscore', 'dysphagia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0427054', 'cui_str': 'Weakness of neck'}, {'cui': 'C0949445', 'cui_str': 'Cervical Dystonia'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",1144.0,0.523,"We found no evidence supporting the existence of a clear dose-response relationship between BtA and improvement in cervical dystonia-specific impairment, a destinction between BtA formulations, or a variation with use of EMG-guided injection for efficacy outcomes.","[{'ForeName': 'Filipe B', 'Initials': 'FB', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Gonçalo S', 'Initials': 'GS', 'LastName': 'Duarte', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Raquel E', 'Initials': 'RE', 'LastName': 'Marques', 'Affiliation': 'Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Castelão', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sampaio', 'Affiliation': 'CHDI Foundation, Princeton, NJ, USA.'}, {'ForeName': 'Austen P', 'Initials': 'AP', 'LastName': 'Moore', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Costa', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD003633.pub4']
1884,33181374,Exercise adherence in Hispanic adolescents with obesity or type 2 diabetes.,"PURPOSE


Hispanic adolescents experience high rates of obesity and type 2 diabetes. The purpose of this study was to examine adherence to a 16-week personalized exercise intervention and the perception of family support for exercise, benefits and barriers to exercise and overall health in Hispanic adolescents diagnosed with obesity or type 2 diabetes.
DESIGN AND METHODS


Using a secondary analysis of a larger feasibility trial, data from 21 Hispanic adolescents, 13 with T2D and 8 who were obese and 14 that completed the entire 16-week study (7 T2D; 7 obese) were analyzed. Adolescents wore an Actigraph™ accelerometer for tracking exercise throughout the 16-week intervention.
RESULTS


The adherence rate for the intervention was 59% for those with T2D and was 88% for those with obesity. Overall perceptions of health improved for those completing the 16-week intervention. Barriers to exercise were negatively associated with moderate-to-vigorous physical activity and were higher in those with T2D.
CONCLUSIONS


Adolescents with T2D were less adherent to their personalized exercise program than those who were obese.
PRACTICE IMPLICATIONS


Strategies that address cultural preferences and family engagement are needed to address barriers to exercise for Hispanic youth, particularly those already diagnosed with T2D that have high risks for early onset of disease complications.",2020,"Barriers to exercise were negatively associated with moderate-to-vigorous physical activity and were higher in those with T2D.
","['Adolescents with T2D', '21 Hispanic adolescents, 13 with T2D and 8 who were obese and 14 that completed the entire 16-week study (7 T2D; 7 obese', 'Hispanic adolescents with obesity or type 2 diabetes', 'Hispanic adolescents experience high rates of obesity and type 2 diabetes', 'Hispanic adolescents diagnosed with obesity or type 2 diabetes']","['Actigraph™ accelerometer for tracking exercise', 'personalized exercise program', 'personalized exercise intervention and the perception of family support for exercise, benefits and barriers to exercise and overall health']","['moderate-to-vigorous physical activity', 'Overall perceptions of health', 'adherence rate', 'Exercise adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0273721,"Barriers to exercise were negatively associated with moderate-to-vigorous physical activity and were higher in those with T2D.
","[{'ForeName': 'Melissa Spezia', 'Initials': 'MS', 'LastName': 'Faulkner', 'Affiliation': 'Professor and Lewis Distinguished Chair in Nursing, Byrdine F. Lewis College of Nursing and Health Professions, Georgia State University, P.O. Box 4019, Atlanta, GA 30302-4019, United States of America. Electronic address: mfaulkner@gsu.edu.'}, {'ForeName': 'Sara Fleet', 'Initials': 'SF', 'LastName': 'Michaliszyn', 'Affiliation': 'Associate Professor and Department Chair, Department of Kinesiology and Sport Science, Youngstown State University, Youngstown, OH, United States of America.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.09.012']
1885,33182295,Effects of Pre-Workout Multi-Ingredient Supplement on Anaerobic Performance: Randomized Double-Blind Crossover Study.,"BACKGROUND


The purpose of this research was to investigate the acute effects of a pre-workout supplement on anaerobic performance in resistance-trained men.
METHODS


Twenty-three men underwent three randomized, double-blind testing sessions separated by a seven-day break. The participants performed three tests: isokinetic strength, three repetition maximum (3-RM) strength and Wingate. Statistical analysis was conducted in R environment. Linear mixed models were estimated via R package lme4.
RESULTS


Mean T@0.2 s was significantly greater in supplemented condition for right and left knee flexors (PL: 103.2 ± 37.6 Nm; supplemented condition: 131.8 ± 29.3 Nm ( p  = 0.001)), and PL: 103.7 ± 39.3; supplemented condition: 129.4 ± 28.4 ( p  = 0.001)). T@0.2 s for right and left knee extensors (PL: 202.6 ± 58.6 Nm; supplemented condition: 237.2 ± 54.7 Nm ( p  = 0.001); PL: 203.3 ± 63.2 Nm, supplemented condition: 229.8 ± 50.8 Nm ( p  = 0.002)). Significant difference was in mean anaerobic power between supplemented and PL condition for right and left knee flexors ( p  = 0.002,  p  = 0.005) and for right and left knee extensors ( p  = 0.001 and  p  = 0.002). TTP was significantly shorter in supplemented condition for both sides knee flexors ( p  = 0.002). There was a significant difference for mean power in the Wingate test (placebo: 8.5 ± 0.6 W/kg; supplemented condition: 8.7 ± 0.5 W/kg ( p  = 0.038)). Mean 3-RM was significantly greater in supplemented condition ( p  = 0.001).
CONCLUSIONS


The supplement significantly improves upper and lower body strength and power output in resistance-trained men.",2020,"Significant difference was in mean anaerobic power between supplemented and PL condition for right and left knee flexors ( p  = 0.002,  p  = 0.005) and for right and left knee extensors ( p  = 0.001 and  p  = 0.002).","['Twenty-three men', 'resistance-trained men']","['Pre-Workout Multi-Ingredient Supplement', 'pre-workout supplement']","['upper and lower body strength and power output', 'right and left knee extensors', 'anaerobic performance', 'mean anaerobic power between supplemented and PL condition for right and left knee flexors', 'mean power', 'TTP', 'Anaerobic Performance', 'isokinetic strength, three repetition maximum (3-RM) strength and Wingate', 'Mean 3-RM']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",23.0,0.34504,"Significant difference was in mean anaerobic power between supplemented and PL condition for right and left knee flexors ( p  = 0.002,  p  = 0.005) and for right and left knee extensors ( p  = 0.001 and  p  = 0.002).","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kaczka', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, ul. Mikołowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Batra', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, ul. Mikołowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kubicka', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, ul. Mikołowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Maciejczyk', 'Affiliation': 'Department of Physiology and Biochemistry, University of Physical Education in Krakow, al. Jana Pawła II 78, 31-571 Kraków, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Rzeszutko-Bełzowska', 'Affiliation': 'Faculty of Physical Education, University of Rzeszow, ul. Towarnickiego 3, 35-010 Rzeszów, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Pezdan-Śliż', 'Affiliation': 'Faculty of Physical Education, University of Rzeszow, ul. Towarnickiego 3, 35-010 Rzeszów, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Michałowska-Sawczyn', 'Affiliation': 'Department of Molecular Biology, Gdansk University of Physical Education and Sport, ul. Kazimierza Górskiego, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Przydział', 'Affiliation': 'Faculty of Physical Education, University of Rzeszow, ul. Towarnickiego 3, 35-010 Rzeszów, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Płonka', 'Affiliation': 'Faculty of Physical Education, University of Rzeszow, ul. Towarnickiego 3, 35-010 Rzeszów, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Cięszczyk', 'Affiliation': 'Department of Molecular Biology, Gdansk University of Physical Education and Sport, ul. Kazimierza Górskiego, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Humińska-Lisowska', 'Affiliation': 'Department of Molecular Biology, Gdansk University of Physical Education and Sport, ul. Kazimierza Górskiego, 80-336 Gdańsk, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zając', 'Affiliation': 'Department of Sport Nutrition, Academy of Physical Education in Katowice, ul. Mikołowska 72a, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17218262']
1886,33183258,Comparison of the effectiveness and safety of intravenous and topical regimens of tranexamic acid in complex tibial plateau fracture: a retrospective study.,"BACKGROUND


Previous studies have demonstrated the effectiveness and safety of tranexamic acid (TXA) in orthopedic surgery. However, no study has investigated TXA in complex tibial plateau fracture surgery. Therefore, the purpose of this study was to confirm the safety and effectiveness of i.v. (intravenous) TXA and topical TXA.
MATERIAL AND METHODS


This was a retrospective analysis of prospectively collected data. The control group received an equal amount of placebo (physiological saline solution); the i.v. group received 1.0 g TXA by intravenous injection before the tourniquet was inflated and before the surgical incision was closed, and the topical group received 3.0 g TXA in 75 mL of physiological saline solution 5 min prior to the final tourniquet release. Perioperative blood loss, vascular events, wound complications, and adverse reactions were compared among the three groups. The pain, knee function, and quality of life (QoL) assessments were based on their corresponding scoring systems.
RESULTS


Baseline data were comparable for all groups. The i.v. group showed the best results for total blood loss (TBL) and hidden blood loss (HBL) (424.5 ± 49.4 mL and 219.3 ± 33.4 mL, respectively, all P values < 0.001). Patients in the i.v. group had lesser real Hb decrease than those in the control group (0.9 vs 1.5, P<0.001) and topical group (0.9 vs 1.2, P = 0.026). The blood coagulation level as measured using fibrinolysis (D-dimer) was lower in the i.v. group than in the control and topical groups on POD1 and POD3; however, this difference was not significant; the fibrin-degradation products also showed a similar trend. Patients in the topical group experienced less pain than those in the control group on POD2, POD4, and PO6W. The VAS pain score was 3.6 vs. 4.4 (POD2, P<0.05), 2.8 vs 3.3 (POD4, P<0.05), and 2.1 vs. 2.6 (PO6W, P<0.001) in the topical group vs control group, respectively. No significant differences were identified in vascular events, wound complications, adverse reactions, knee function, and QoL among the three groups.
CONCLUSION


To our knowledge, this is the first study that showed both i.v. TXA and topical TXA are safe and effective for complex tibial plateau fractures. The i.v. regimen effectively reduced blood loss during the perioperative period, whereas patients under the topical regimen had less vascular events, wound complications, and a lower incidence of adverse reactions compared to those in the i.v. group.
TRIAL REGISTRATION


The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR-TRC-1800017754 , retrospectively registered from 2018 to 01-01).",2020,"No significant differences were identified in vascular events, wound complications, adverse reactions, knee function, and QoL among the three groups.
","['orthopedic surgery', 'complex tibial plateau fracture']","['TXA in 75\u2009mL of physiological saline solution', 'TXA and topical TXA', 'tranexamic acid (TXA', 'tranexamic acid', 'placebo (physiological saline solution', 'TXA']","['total blood loss (TBL) and hidden blood loss (HBL', 'POD2, POD4, and PO6W. The VAS pain score', 'vascular events, wound complications, adverse reactions, knee function, and QoL', 'blood coagulation level', 'adverse reactions', 'real Hb decrease', 'fibrin-degradation products', 'vascular events, wound complications', 'safety and effectiveness', 'Perioperative blood loss, vascular events, wound complications, and adverse reactions', 'POD1 and POD3', 'blood loss', 'pain, knee function, and quality of life (QoL) assessments', 'pain']","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0163275', 'cui_str': 'Fibrin degradation product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0757594,"No significant differences were identified in vascular events, wound complications, adverse reactions, knee function, and QoL among the three groups.
","[{'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Qinghai University, Xi'ning, 810000, Qinghai, China.""}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics and Trauma, Hong Hui Hospital, Xi'an Jiaotong University College of Medicine, No. 555, East Youyi Road, Xi'an, 710000, Shaanxi, China. hhzhangkun@163.com.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics and Trauma, The Second Affiliated Hospital of Xi'an Medical College, No. 167, East Textile Road, Xi'an, 710000, Shaanxi, China. 1109302522@foxmail.com.""}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03772-7']
1887,33183274,"The inclusion of mobilisation with movement to a standard exercise programme for patients with rotator cuff related pain: a randomised, placebo-controlled protocol trial.","BACKGROUND


Rotator cuff related pain (RCRP) is one of the most common sources of musculoskeletal shoulder pain affecting the general population. Conservative treatment, in the form of exercise, is considered the first line approach, nonetheless, improvements seem to be modest. One therapeutic modality that might be an adjunct to the treatment of this condition is mobilisation with movement (MWM). MWM is a pain-free manual procedure that targets restricted and painful movements, commonly seen in patients with RCRP. The purpose of clinical trial is to determine whether MWM with exercise has benefits over sham MWM with exercise in RCRP.
METHODS


A randomised, sham-controlled trial of 70 adults complaining of RCRP will compare the effects of MWM combined with exercise over sham MWM with exercise. Participants will be allocated to one of two groups: exercise and MWM (EG) or exercise and sham MWM (CG). Two weekly individual treatment sessions will be conducted over five weeks. All assessments will be performed by a blinded assessor. Primary outcome measures will be the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS), assessed at baseline, discharge and one-month follow-up. Secondary outcome measures will be active range of motion, self-efficacy and the global rating of change scale. The analyses will be conducted considering a statistically significant p-value ≤0.05. Normality will be assessed with the Kolmogorov-Smirnov test and homogeneity with the Levene's test. For the primary outcome measures (SPADI and NPRS) and self-efficacy, a 2 × 3 ANOVA with treatment group (EG versus CG) and time (baseline, end of the treatment and follow-up) factors will be performed. Separate 2 × 2 ANOVA will be used for range of motion (baseline and end of the treatment). Global rating scale of change analysis will be conducted using descriptive statistics. Intention-to-treat analysis will be adopted.
DISCUSSION


As there is a paucity of longitudinal studies investigating the use of MWM in patients with RCRP, this study will help to better understand its role together with a structured exercise programme.
TRIAL REGISTRATION


Clinical Trials Registry number NCT04175184 . November, 2019.",2020,Participants will be allocated to one of two groups: exercise and MWM (EG) or exercise and sham MWM (CG).,"['patients with rotator cuff related pain', '70 adults complaining of RCRP', 'patients with RCRP', 'Rotator cuff related pain (RCRP']","['MWM with exercise', 'exercise and MWM (EG) or exercise and sham MWM (CG', 'placebo', 'MWM combined with exercise over sham MWM with exercise', 'standard exercise programme', 'MWM']","['Global rating scale', 'SPADI and NPRS) and self-efficacy', 'shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS), assessed at baseline, discharge and one-month follow-up', 'active range of motion, self-efficacy and the global rating of change scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",70.0,0.294004,Participants will be allocated to one of two groups: exercise and MWM (EG) or exercise and sham MWM (CG).,"[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Baeske', 'Affiliation': 'Science of Rehabilitation programme at Universidade Federal de Ciências da Saúde de Porto Alegre, Rua Sarmento Leite, 245, Porto Alegre, Rio Grande do Sul, CEP 90050-170, Brazil. rbaeske@yahoo.com.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy & Exercise Science, Curtin University, Kent Street, Bentley, Western Australia, 6102.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre, Rua Sarmento Leite, 245, Porto Alegre, Rio Grande do Sul, CEP 90050-170, Brazil.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03765-6']
1888,33183320,"Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia.","BACKGROUND


Reduction in elevated serum cholesterol concentrations is important in the management of individuals at risk of atherosclerotic cardiovascular disease (ASCVD), such as myocardial infarction and thrombotic stroke. Although HMGCoA reductase inhibitors (""statins"") are frequently used for this purpose, a significant proportion of patients remain at increased residual risk of ASCVD as they do not adequately address some of the associated co-morbidities such as diabetes and fatty liver disease.
METHODS


A double-blind, randomized, placebo-controlled, dose ranging study was carried out that compared three doses of berberine ursodeoxycholate (BUDCA) to placebo in a cohort of subjects with a history of hypercholesterolemia and serum LDL cholesterol levels above 2.59 mmol/L (> 99.9 mg/dL). BUDCA was administered in two divided doses each day for 28 days. The primary endpoints of the study were safety and tolerability of this new compound, as well as its effect in lowering serum lipid and lipoprotein concentrations.
RESULTS


A total of 50 subjects were enrolled into three dose cohorts in this study. BUDCA was generally well tolerated, even at doses of 2000 mg per day (the highest dose group); there were no significant adverse effects reported and this highest dose was associated with significant reductions in LDL cholesterol. By day 28 and with the highest dose of BUDCA, there were significant reductions in the serum concentrations of total cholesterol by 8.2% (P = 0.0004) and LDL cholesterol by 10.4% (P = 0.0006), but no significant changes in triglyceride and HDL cholesterol concentrations.
CONCLUSIONS


BUDCA is a new single molecular entity that has a significant but modest effect in safely lowering serum LDL-cholesterol concentrations in individuals with a history of hypercholesterolemia. It has a potential use for treating hypercholesterolemia in individuals who cannot take statins, and possibly as adjunctive to other agents, such as ezetimibe or bempedoic acid.
TRIAL REGISTRATION


The study was registered on Clinicaltrials.gov ( NCT03381287 ).",2020,"By day 28 and with the highest dose of BUDCA, there were significant reductions in the serum concentrations of total cholesterol by 8.2% (P = 0.0004) and LDL cholesterol by 10.4% (P = 0.0006), but no significant changes in triglyceride and HDL cholesterol concentrations.
","['individuals at risk of atherosclerotic cardiovascular disease (ASCVD', 'patients with hyperlipidemia', 'A total of 50 subjects', 'subjects with a history of hypercholesterolemia and serum LDL cholesterol levels above 2.59\u2009mmol/L ', 'individuals with a history of hypercholesterolemia']","['HMGCoA reductase inhibitors (""statins', 'berberine ursodeoxycholate (BUDCA) to placebo', 'BUDCA', 'placebo-controlled', 'HTD1801 (berberine ursodeoxycholate, BUDCA']","['safety and tolerability', 'lowering serum lipid and lipoprotein concentrations', 'LDL cholesterol', 'serum concentrations of total cholesterol', 'tolerated', 'triglyceride and HDL cholesterol concentrations']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533076', 'cui_str': 'History of hypercholesterolemia'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0178882', 'cui_str': 'Ursodeoxycholate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",50.0,0.144586,"By day 28 and with the highest dose of BUDCA, there were significant reductions in the serum concentrations of total cholesterol by 8.2% (P = 0.0004) and LDL cholesterol by 10.4% (P = 0.0006), but no significant changes in triglyceride and HDL cholesterol concentrations.
","[{'ForeName': 'Adrian M', 'Initials': 'AM', 'LastName': 'Di Bisceglie', 'Affiliation': 'Department of Internal Medicine, Saint Louis University, St. Louis, USA. adibisceglie@hightidetx.com.'}, {'ForeName': 'Gerald F', 'Initials': 'GF', 'LastName': 'Watts', 'Affiliation': 'Department of Cardiology, Royal Perth Hospital, School of Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lavin', 'Affiliation': 'Boston Biostatistics Research Foundation, Framingham, MA, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'HighTide Therapeutics, Rockville, MD, USA.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Bai', 'Affiliation': 'HighTide Therapeutics, Rockville, MD, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'HighTide Therapeutics, Rockville, MD, USA.'}]",Lipids in health and disease,['10.1186/s12944-020-01406-4']
1889,33184024,"A Randomized, Noninferiority Trial Comparing ICS + LABA with ICS + LABA + LAMA in Asthma-COPD Overlap (ACO) Treatment: The ACO Treatment with Optimal Medications (ATOMIC) Study.","BACKGROUND


Current guidelines for the treatment of asthma and chronic obstructive pulmonary disease overlap (ACO) recommend initial treatment using inhaled corticosteroids (ICSs) plus 1 or more bronchodilators.
OBJECTIVE


To clarify which therapeutic effect is better between the ICS + long-acting β 2  agonist (LABA) and ICS + LABA + long-acting muscarinic antagonist (LAMA) treatment in patients with ACO.
METHODS


We conducted a multicenter, 48-week, randomized, noninferiority trial. Patients with ACO were enrolled if they were treated with a moderate to high dose of ICS + LABA. In total, 303 patients were involved in the present trial, with 149 receiving ICS + LABA + LAMA. The primary end point was the time to first exacerbation. Secondary outcomes included changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
RESULTS


In the ICS + LABA treatment group, 29 of 154 patients (18.83%) experienced exacerbation, whereas 28 of 149 patients (18.79%) experienced exacerbation in the ICS + LABA + LAMA treatment group. The results of this noninferiority study were ultimately inconclusive (hazard ratio, 1.1; 95% CI, 0.66-1.84). However, the patients treated with the addition of LAMA showed significant improvements in FEV 1  and forced vital capacity (P < .001). Asthma control did not improve in either group.
CONCLUSIONS


Although this study was unable to conclude that ICS + LABA treatment is not inferior to ICS + LABA + LAMA in terms of exacerbation, it is obvious that the ICS + LABA + LAMA treatment group had improved lung function in ACO.",2020,"Secondary outcomes included changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
","['asthma and chronic obstructive pulmonary disease overlap (ACO', 'patients with ACO', '303 patients were involved in the present trial, with 149 receiving ICS\xa0+ LABA\xa0+ LAMA', 'Asthma-COPD Overlap (ACO', 'Patients with ACO']","['inhaled corticosteroids (ICSs', 'ICS\xa0+ LABA', 'LAMA', 'ICS\xa0+ LABA with ICS\xa0+ LABA\xa0+ LAMA']","['FEV 1  and forced vital capacity', 'changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide', 'time to first exacerbation', 'lung function']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",303.0,0.155535,"Secondary outcomes included changes in FEV 1 , forced vital capacity, FEV 1 /forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
","[{'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea. Electronic address: tbkim@amc.seoul.kr.'}, {'ForeName': 'Solmi', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Clinical Immunology, Armed Forces Capital Hospital, Seongnam, Korea.'}, {'ForeName': 'Sae-Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Division of Allergy and Clinical Immunology, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Chungnam National University Hospital, Chungnam University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Min-Hye', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji-Yong', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min-Suk', 'Initials': 'MS', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.'}, {'ForeName': 'Jeong-Hee', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea; Allergy and Clinical Immunology Research Center, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Chan Sun', 'Initials': 'CS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.'}, {'ForeName': 'Sujeong', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Jaechun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Jeju National University School of Medicine, Jeju, Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Kwon', 'Affiliation': 'Department of Allergy and Clinical Immunology, Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Gyu Young', 'Initials': 'GY', 'LastName': 'Hur', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Ha', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Hee-Kyoo', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Yoo Seob', 'Initials': 'YS', 'LastName': 'Shin', 'Affiliation': 'Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sang-Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'An-Soo', 'Initials': 'AS', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University School of Medicine, Bucheon, Korea.'}, {'ForeName': 'Seo Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae-Bum', 'Initials': 'TB', 'LastName': 'Kim', 'Affiliation': 'Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.09.066']
1890,33184076,Treatment with the anti-IgE monoclonal antibody omalizumab in women with asthma undergoing fertility treatment: a proof-of-concept study-The PRO-ART study protocol.,"INTRODUCTION


Asthma is associated with prolonged time to pregnancy and a higher need for fertility treatment. However, the mechanism underlying this association remains incompletely understood. Previous research points to asthma-driven systemic inflammation also affecting the reproductive organs and thereby fertility. The aim of this study was to determine if treatment with omalizumab prior to fertility treatment will increase pregnancy rate among women with asthma by decreasing the systemic asthma-related inflammation and, by that, to provide insight into the underlying mechanisms.
METHODS AND ANALYSIS


This is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark. The patients are randomised 1:1 to either omalizumab or placebo. The primary endpoint is the difference in pregnancy rate confirmed with ultrasound at gestational week 7 of pregnancy. The secondary endpoints are change in sputum and blood eosinophil cell count, change in biomarkers, change in microbiota, together with rate of pregnancy loss, frequency of malformations, pre-eclampsia, preterm birth, birth weight, small for gestational age and perinatal death between groups.
ETHICS AND DISSEMINATION


The methods used in this study are of low risk, but if successful, our findings will have a large impact on a large group of patients as infertility and asthma are the most common chronic diseases among the young population. The study has been approved by the Ethics Committee-Danish national research ethics committee (H-18016605) and the Danish Medicines Agency (EudraCT no: 2018-001137-41) and the Danish Data Protection Agency (journal number: VD-2018486 and I-Suite number 6745). The test results will be published regardless of whether they are positive, negative or inconclusive. Publication in international peer-reviewed scientific journals is planned.
TRIAL REGISTRATION NUMBER


NCT03727971.",2020,This is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark.,"['women with asthma undergoing fertility treatment', '180 women with asthma recruited from fertility clinics in Denmark', 'women with asthma by decreasing the systemic asthma-related inflammation']","['omalizumab or placebo', 'omalizumab', 'anti-IgE monoclonal antibody omalizumab']","['pregnancy rate confirmed with ultrasound at gestational week 7 of pregnancy', 'change in sputum and blood eosinophil cell count, change in biomarkers, change in microbiota, together with rate of pregnancy loss, frequency of malformations, pre-eclampsia, preterm birth, birth weight, small for gestational age and perinatal death', 'pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0051978', 'cui_str': 'Anti-Immunoglobulin E antibody'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}]",180.0,0.32934,This is an ongoing prospective multicentre randomised controlled trial planned to enrol 180 women with asthma recruited from fertility clinics in Denmark.,"[{'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Tidemandsen', 'Affiliation': 'Department of Respiratory Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark casper.tidemandsen.02@regionh.dk.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Juul Gade', 'Affiliation': 'Department of Obstetrics and Gynecology, Roskilde Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henriette Svarre', 'Initials': 'HS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Birgitte Sophie', 'Initials': 'BS', 'LastName': 'Oxlund-Mariegaard', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Kristiansen', 'Affiliation': 'Laboratory of Genomics and Molecular Biomedicine, Department of Biology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nina La Cour', 'Initials': 'NC', 'LastName': 'Freiesleben', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bugge', 'Initials': 'B', 'LastName': 'Nøhr', 'Affiliation': 'Fertility Clinic, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Udengaard', 'Affiliation': 'Fertility Clinic, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Backer', 'Affiliation': 'Centre for Physical Activity Research, Rigshospitalet, Kobenhavn, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-037041']
1891,33184083,Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial.,"INTRODUCTION


Lopinavir/ritonavir (LPV/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.
METHODS AND ANALYSIS


COPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV/r (400 mg/100 mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Commission Cantonale d'Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov Registry (NCT04364022); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).
REGISTERED REPORT IDENTIFIER


CCER 2020-0864.",2020,"The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline.","['Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19', 'adults exposed to SARS-CoV-2', 'adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP', '200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total']","['Lopinavir/ritonavir (LPV/r', 'pragmatic same-day ring prophylaxis']","['21-day incidence of COVID-19 as well as SARS-CoV-2 infection', 'positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology', '21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.414348,"The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline.","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Smit', 'Affiliation': 'HIV Unit, Geneva University Hospitals, Geneva, Switzerland mikaela.smit@hcuge.ch.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Marinosci', 'Affiliation': 'HIV Unit, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Giovanni Jacopo', 'Initials': 'GJ', 'LastName': 'Nicoletti', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Perneger', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Ragozzino', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Diego O', 'Initials': 'DO', 'LastName': 'Andrey', 'Affiliation': 'HIV Unit, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Stoeckle', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frederique', 'Initials': 'F', 'LastName': 'Jacquerioz', 'Affiliation': 'Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lebowitz', 'Affiliation': 'Infection Control Programme, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Agoritsas', 'Affiliation': 'Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Centre for Vaccinology, Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Spechbach', 'Affiliation': 'Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Salamun', 'Affiliation': 'Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Back', 'Affiliation': 'Gesundheitsdepartement, Canton of Basel City, Basel, Switzerland.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Schaubhut', 'Affiliation': 'Gesundheitsdepartement, Canton of Basel City, Basel, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fuchs', 'Affiliation': 'Gesundheitsdepartement, Canton of Basel City, Basel, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Decosterd', 'Affiliation': 'Laboratory of Clinical Pharmacology, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Guessous', 'Affiliation': 'Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Chappuis', 'Affiliation': 'Department of Primary Care, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Niklaus D', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'HIV Unit, Geneva University Hospitals, Geneva, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2020-040110']
1892,33187518,"Understanding the effects of beetroot juice intake on CrossFit performance by assessing hormonal, metabolic and mechanical response: a randomized, double-blind, crossover design.","BACKGROUND


Acute beetroot juice (BJ) intake has shown to enhance aerobic and anaerobic performance. However, no studies have evaluated the effects of BJ intake on CrossFit (CF) performance by linking hormonal, metabolic, and mechanical responses. The purpose of this study was to determine the causal physiological association between hormonal, metabolic and mechanical responses, and CF workouts performance after acute BJ intake.
METHODS


Twelve well-trained male practitioners undertook a CF workout after drinking 140 mL of BJ (~ 12.8 mmol NO 3 - ) or placebo. The two experimental conditions (BJ or placebo) were administered using a randomized, double-blind, crossover design. The CF workout consisted of repeating the same exercise routine twice: Wall ball (WB) shots plus full back squat (FBS) with 3-min rest (1st routine) or without rest (2nd routine) between the two exercises. A 3-min rest was established between the two exercise routines.
RESULTS


An interaction effect was observed in the number of repetitions performed (p = 0.04). The Bonferroni test determined a higher number of repetitions after BJ than placebo intake when a 3-min rest between WB and FBS (1st routine) was established (p = 0.007). An interaction effect was detected in cortisol response (p = 0.04). Cortisol showed a higher increase after BJ compared to placebo intake (76% vs. 36%, respectively). No interaction effect was observed in the testosterone and testosterone/cortisol ratio (p > 0.05). A significant interaction effect was found in oxygen saturation (p = 0.01). A greater oxygen saturation drop was observed in BJ compared to placebo (p <  0.05). An interaction effect was verified in muscular fatigue (p = 0.03) with a higher muscular fatigue being observed with BJ than placebo (p = 0.02).
CONCLUSIONS


BJ intake improved anaerobic performance only after the recovery time between exercises. This increase in performance in the first routine probably generated greater hypoxia in the muscle mass involved, possibly conditioning post-exercise performance. This was observed with a fall in oxygen saturation and in muscle fatigue measured at the end of the CF workout. The greatest perceived changes in cortisol levels after BJ intake could be attributed to the nitrate-nitrite-nitric oxide pathway.",2020,"An interaction effect was verified in muscular fatigue (p = 0.03) with a higher muscular fatigue being observed with BJ than placebo (p = 0.02).
",['Twelve well-trained male practitioners undertook a'],"['CF workout consisted of repeating the same exercise routine twice: Wall ball (WB) shots plus full back squat (FBS) with 3-min rest (1st routine) or without rest', 'CF workout \ufeffafter drinking 140\u2009mL of BJ (~\u200912.8\u2009mmol NO 3 - ) or placebo', 'placebo', 'beetroot juice intake']","['oxygen saturation', 'testosterone and testosterone/cortisol ratio', 'muscular fatigue', 'BJ intake on CrossFit (CF) performance by linking hormonal, metabolic, and mechanical responses', 'anaerobic performance', 'oxygen saturation and in muscle fatigue', 'cortisol levels', 'cortisol response', 'CrossFit performance by assessing hormonal, metabolic and mechanical response']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",,0.337014,"An interaction effect was verified in muscular fatigue (p = 0.03) with a higher muscular fatigue being observed with BJ than placebo (p = 0.02).
","[{'ForeName': 'Manuel Vicente', 'Initials': 'MV', 'LastName': 'Garnacho-Castaño', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain. mgarnacho@escs.tecnocampus.cat.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Palau-Salvà', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Serra-Payá', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ruiz-Hermosel', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Berbell', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Viñals', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Manuel Gomis', 'Initials': 'MG', 'LastName': 'Bataller', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Carbonell', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, University of Barcelona, Avda Diagonal 643, 08028, Barcelona, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vilches-Saez', 'Affiliation': 'GRI-AFIRS. School of Health Sciences, TecnoCampus-Pompeu Fabra University, Ernest Lluch, 32 (Porta Laietana), Mataró, 08302, Barcelona, Spain.'}, {'ForeName': 'Eulogio Pleguezuelos', 'Initials': 'EP', 'LastName': 'Cobo', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Hospital de Mataró, Mataró, Barcelona, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Molina-Raya', 'Affiliation': 'Campus Docent Sant Joan de Déu. Fundación Privada, Barcelona, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00388-z']
1893,33187532,Effects of virtual reality training on occupational performance and self-efficacy of patients with stroke: a randomized controlled trial.,"BACKGROUND


Virtual reality (VR) has been broadly applied in post-stroke rehabilitation. However, studies on occupational performance and self-efficacy as primary outcomes of stroke rehabilitation using VR are lacking. Thus, this study aims to investigate the effects of VR training on occupational performance and self-efficacy in patients with stroke.
METHODS


This was an assessor-blinded, randomized controlled trial. Sixty participants with first-ever stroke (< 1-year onset) underwent rehabilitation in a single acute hospital. Participants were randomly assigned to either the VR group (n = 30) or control group (n = 30). Both groups received dose-matched conventional rehabilitation (i.e., 45 min, five times per week over 3 weeks). The VR group received additional 45-min VR training for five weekdays over 3 weeks. The primary outcome measures were the Canadian Occupational Performance Measure and Stroke Self-Efficacy Questionnaire. Secondary outcome measures included Modified Barthel Index, Fugl-Meyer Assessment-Upper Extremity, and Functional Test for the Hemiplegic Upper Extremity. The assessment was conducted at baseline and after the 3-week intervention.
RESULTS


A total of 52 participants (86.7%) completed the trial. Significant between-group differences in Stroke Self-Efficacy Questionnaire (Median Difference = 8, P = 0.043) and Modified Barthel Index (Median Difference = 10, P = 0.030) were found; however, no significant between-group differences in Canadian Occupational Performance Measure, Fugl-Meyer Assessment-Upper Extremity, and Functional Test for the Hemiplegic Upper Extremity were noted. No serious adverse reactions related to the program were reported.
CONCLUSIONS


Additional VR training could help improve the self-efficacy and activities of daily living of patients with stroke; however, it was not superior to conventional training in the improvement of upper limb functions, occupational performance, and satisfaction. Nevertheless, VR could be integrated into conventional rehabilitation programs to enhance self-efficacy of patients after stroke.
TRIAL REGISTRATION


This study was successfully registered under the title ""Effects of virtual reality training on occupational performance and self-efficacy of patients with stroke"" on October 13 2019 and could be located in https://www.chictr.org with the study identifier ChiCTR1900026550.",2020,"Significant between-group differences in Stroke Self-Efficacy Questionnaire (Median Difference = 8, P = 0.043) and Modified Barthel Index (Median Difference = 10, P = 0.030) were found; however, no significant between-group differences in Canadian Occupational Performance Measure, Fugl-Meyer Assessment-Upper Extremity, and Functional Test for the Hemiplegic Upper Extremity were noted.","['A total of 52 participants (86.7%) completed the trial', 'Sixty participants with first-ever stroke (<\u20091-year onset) underwent rehabilitation in a single acute hospital', 'patients with stroke', 'patients with stroke"" on October 13 2019']","['virtual reality training', 'VR group (n\u2009=\u200930) or control group', 'dose-matched conventional rehabilitation', 'Virtual reality (VR', 'additional 45-min VR training', 'VR training']","['Canadian Occupational Performance Measure, Fugl-Meyer Assessment-Upper Extremity, and\xa0Functional Test for the Hemiplegic Upper Extremity', 'occupational performance and self-efficacy', 'Modified Barthel Index, Fugl-Meyer Assessment-Upper Extremity, and\xa0Functional Test for the Hemiplegic Upper Extremity', 'upper limb functions, occupational performance, and satisfaction', 'Canadian Occupational Performance Measure and Stroke Self-Efficacy Questionnaire', 'Stroke Self-Efficacy Questionnaire', 'self-efficacy and activities of daily living', 'serious adverse reactions', 'Modified Barthel Index']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",60.0,0.0742407,"Significant between-group differences in Stroke Self-Efficacy Questionnaire (Median Difference = 8, P = 0.043) and Modified Barthel Index (Median Difference = 10, P = 0.030) were found; however, no significant between-group differences in Canadian Occupational Performance Measure, Fugl-Meyer Assessment-Upper Extremity, and Functional Test for the Hemiplegic Upper Extremity were noted.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Rehabilitation, Xiangya Hospital Central South University, No. 87 Xiangya Road, Changsha, 410008, Hunan, China.'}, {'ForeName': 'Rang-Ge', 'Initials': 'RG', 'LastName': 'Ouyang', 'Affiliation': 'Department of Rehabilitation, Xiangya Hospital Central South University, No. 87 Xiangya Road, Changsha, 410008, Hunan, China. rangge.ouyang@connect.polyu.hk.'}, {'ForeName': 'Jia-Qi', 'Initials': 'JQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong SAR, China.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00783-2']
1894,33187535,"Weight loss before total joint arthroplasty using a remote dietitian and mobile app: study protocol for a multicenter randomized, controlled trial.","BACKGROUND


The months prior to elective surgery may present an opportunity for patients to initiate behavior changes that will simultaneously ready them for surgery and improve their overall health status. An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m 2 ) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m 2  as a cut-off for offering surgery in an effort to optimize outcomes.
METHODS


The purpose of this multicenter randomized, controlled trial is to assess the feasibility and efficacy of a 12-week remote dietitian (RD) supervised dietary and physical activity weight loss intervention and mobile app for 60 patients with severe obesity prior to undergoing TJA. Intervention participants will receive access to a smartphone app and connect with an RD who will contact these participants weekly or bi-weekly via video calls for up to nine video calls. Together, participants and RDs will set goals for lifestyle modifications, and RDs will check on progress towards achieving these goals using in-app tools such as food logs and text messages between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI < 40 kg/m 2  after 12 weeks. Individuals randomized to the control group will receive clinical standard of care, such as nutritionist and/or physical therapy referrals. Outcome and demographic data will be collected from blood serology, chart review, mobile app user data, pre- and postintervention surveys, and phone interviews. The primary outcome measure will be weight change from baseline. Secondary outcome measures will include percentage of patients eligible to undergo TJA, number of sessions completed with dietitians, self-reported global health status (PROMIS Global Health scale), self-reported joint-specific pain and function (Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)), and serologies such as hemoglobin A1c, total lymphocyte count, albumin, and transferrin. Qualitative responses transcribed from phone interviews about the intervention will also be analyzed.
DISCUSSION


This will be the first study to assess pre-operative weight loss in patients with severe obesity anticipating orthopaedic surgery using an RD and mobile app intervention aimed at helping patients become eligible for TJA.
TRIAL REGISTRATION


Registered on 1 April 2020 at Clincialtrials.gov. Trial number is NCT04330391 .",2020,"An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m 2 ) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m 2  as a cut-off for offering surgery in an effort to optimize outcomes.
","['60 patients with severe obesity prior to undergoing TJA', 'patients with severe obesity (body mass index [BMI]> 40 kg/m 2 ', 'patients with severe obesity anticipating orthopaedic surgery using an RD and mobile app intervention aimed at helping patients become eligible for TJA']","['smartphone app and connect with an RD who will contact these participants weekly or bi-weekly via video calls', 'elective total joint arthroplasty (TJA', 'remote dietitian (RD) supervised dietary and physical activity weight loss intervention and mobile app', 'control group will receive clinical standard of care, such as nutritionist and/or physical therapy referrals']","['weight change from baseline', 'feasibility and efficacy', 'Weight loss', 'percentage of patients eligible to undergo TJA, number of sessions completed with dietitians, self-reported global health status (PROMIS Global Health scale), self-reported joint-specific pain and function (Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)), and serologies such as hemoglobin A1c, total lymphocyte count, albumin, and transferrin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0237083', 'cui_str': 'Nutritionist'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}]",60.0,0.121654,"An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m 2 ) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m 2  as a cut-off for offering surgery in an effort to optimize outcomes.
","[{'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Seward', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA. mseward@post.harvard.edu.""}, {'ForeName': 'Brielle J', 'Initials': 'BJ', 'LastName': 'Antonelli', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Giunta', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Iorio', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Fitz', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'Jeffrey K', 'Initials': 'JK', 'LastName': 'Lange', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'Vivek M', 'Initials': 'VM', 'LastName': 'Shah', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}, {'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.""}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-02059-w']
1895,33187542,The BEACON study: protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario.,"BACKGROUND


Patients who present to emergency departments after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by suicide in Ontario. One way of potentially addressing this gap is to offer a course of blended problem-solving therapy, comprised of a brief course of evidence-based psychotherapy for individuals at risk for suicide, facilitated by the use of a patient-facing smartphone application and a clinician-facing ""dashboard."" This approach has the potential to combine the benefits of face-to-face therapy and technology to create a novel intervention.
METHODS


This is a cohort study nested within a larger pragmatic multicentre pre- and post-design cluster randomised trial. Suicidal ideation assessed by the Beck Scale for Suicide Ideation is the primary outcome variable. Secondary outcome measures include depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory-Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data. A process evaluation will also be conducted following study completion.
DISCUSSION


The cohort study will test whether better adherence to the intervention results in better outcomes. The value of the cohort study design is that we can examine in more detail certain subgroups or other variables that are not available in the larger cluster randomised trial. This trial will aim to improve standards by informing best practice in management of men who self-harm and present to hospitals in Ontario.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03473535 . Registered on March 22, 2018.",2020,"Secondary outcome measures include depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory-Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data.","['men, who represent nearly two-thirds of those who die by suicide in Ontario', 'men who self-harm and present to hospitals in Ontario', 'men who present with intentional self-harm to emergency departments in Ontario']",['smartphone-assisted problem-solving therapy'],"['depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory-Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data', 'Suicidal ideation assessed by the Beck Scale for Suicide Ideation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0480203', 'cui_str': 'Self inflicted injury'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation'}]",,0.104071,"Secondary outcome measures include depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory-Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hatcher', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada. shatcher@toh.ca.'}, {'ForeName': 'Marnin', 'Initials': 'M', 'LastName': 'Heisel', 'Affiliation': 'Lawson Health Research Institute, London, Canada.'}, {'ForeName': 'Oyedeji', 'Initials': 'O', 'LastName': 'Ayonrinde', 'Affiliation': ""Queen's University, Kingston, Canada.""}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Campbell', 'Affiliation': 'Canadian Association for Suicide Prevention, Winnipeg, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Colman', 'Affiliation': 'University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Corsi', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Edgar', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Gillett', 'Affiliation': 'Sioux Lookout Meno Ya Win Health Centre, Sioux Lookout, Canada.'}, {'ForeName': 'Sidney H', 'Initials': 'SH', 'LastName': 'Kennedy', 'Affiliation': ""St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Sophia Lakatoo', 'Initials': 'SL', 'LastName': 'Hunt', 'Affiliation': 'William Osler Health System, Toronto, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Links', 'Affiliation': 'McMaster University, Hamilton, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacLean', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Mehta', 'Affiliation': 'Western University, London, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mushquash', 'Affiliation': 'Lakehead University, Thunder Bay, Canada.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Raimundo', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Sakina J', 'Initials': 'SJ', 'LastName': 'Rizvi', 'Affiliation': ""St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Saskin', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Canada.'}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Schaffer', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Alaaddin', 'Initials': 'A', 'LastName': 'Sidahmed', 'Affiliation': 'Wayne State University, Detroit, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sinyor', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Soares', 'Affiliation': ""Queen's University, Kingston, Canada.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Testa', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Thiruganasambandamoorthy', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vaillancourt', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}]",Trials,['10.1186/s13063-020-04424-w']
1896,33190274,"Storms, Fires, and Bombs: Analyzing the Impact of Warning Message and Receiver Characteristics on Risk Perception in Different Hazards.","In crisis communication, warning messages are key to prevent or mitigate damage by informing the public about impending risks and hazards. The present study explored the influence of hazard type, trait anxiety, and warning message on different components of risk perception. A survey examined 614 German participants (18-96 years, M = 31.64, 63.0% female) using a pre-post comparison. Participants were randomly allocated to one of five hazards (severe weather, act of violence, breakdown of emergency number, discovery of a World War II bomb, or major fire) for which they received a warning message. Four components of risk perception (perceived severity, anticipatory worry, anticipated emotions, and perceived likelihood) were measured before and after the receipt. Also, trait anxiety was assessed. Analyses of covariance of risk perception were calculated, examining the effect of warning message, trait anxiety, and hazard type while controlling for age, gender, and previous hazard experience. Results showed main effects of hazard type and trait anxiety on every component of risk perception, except for perceived likelihood. The receipt of a warning message led to a significant decrease in anticipated negative emotions. However, changes across components of risk perception, as well as hazards, were inconsistent, as perceived severity decreased while perceived likelihood and anticipatory worry increased. In addition, three interactional effects were found (perceived severity × hazard type, perceived severity × trait anxiety, and anticipated emotions × hazard type). The findings point toward differences in the processing of warning messages yet underline the importance of hazard type, as well as characteristics of the recipient.",2020,The receipt of a warning message led to a significant decrease in anticipated negative emotions.,"['614 German participants (18-96 years, M = 31.64, 63.0% female) using a pre-post comparison']",[],"['negative emotions', 'trait anxiety', 'Storms, Fires, and Bombs', 'hazard type and trait anxiety', 'risk perception (perceived severity, anticipatory worry, anticipated emotions, and perceived likelihood']","[{'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0441726', 'cui_str': 'Bomb'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",614.0,0.0325456,The receipt of a warning message led to a significant decrease in anticipated negative emotions.,"[{'ForeName': 'Maxi', 'Initials': 'M', 'LastName': 'Rahn', 'Affiliation': 'Department Health and Prevention, Institute of Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tomczyk', 'Affiliation': 'Department Health and Prevention, Institute of Psychology, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department Health and Prevention, Institute of Psychology, University of Greifswald, Greifswald, Germany.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13636']
1897,33190355,A higher protein intake at breakfast and lunch is associated with a higher total daily protein intake in older adults: a post-hoc cross-sectional analysis of four randomised controlled trials.,"BACKGROUND


A protein intake of 30-40 g per meal is suggested to maximally stimulate muscle protein synthesis in older adults and could therefore contribute to the prevention of sarcopenia. Protein intake at breakfast and lunch is often low and offers a great opportunity to improve daily protein intake. Protein, however, is known for its satiating effects. Therefore, we explored the association between the amount of protein intake at breakfast and lunch and total daily protein intake in older adults.
METHODS


Protein intake was assessed by a 3-day food record in 498 community dwelling older adults (≥55 years) participating different lifestyle interventions. Linear mixed model analysis was used to examine the association between protein intake at breakfast or lunch and total daily protein intake, adjusted for sex, age, body mass index, smoking status, study and total energy intake.
RESULTS


After adjustment for potential confounders, a 10 g higher protein intake at breakfast was associated with a 3.2 g higher total daily protein intake (P = 0.008) for males and a 4.9 g (P < 0.001) higher total daily protein intake for females. A 10 g higher protein intake at lunch was associated with a 3.7 g higher total daily protein intake (P < 0.001) for males, and a 5.8 g higher total daily protein intake (P < 0.001) for females.
CONCLUSIONS


A higher protein intake at breakfast and lunch is associated with a higher total daily protein intake in community dwelling older adults. Stimulating a higher protein intake at breakfast and lunch might represent a promising nutritional strategy to optimise the amount of protein per meal without compromising total daily protein intake.",2020,A higher protein intake at breakfast and lunch is associated with a higher total daily protein intake in community dwelling older adults.,"['older adults', '498 community dwelling older adults (≥55\xa0years) participating different lifestyle interventions', 'community dwelling older adults']",[],['total daily protein intake'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",498.0,0.0258311,A higher protein intake at breakfast and lunch is associated with a higher total daily protein intake in community dwelling older adults.,"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Verreijen', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van den Helder', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Streppel', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Rotteveel', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Heman', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'van Dronkelaar', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Memelink', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Engberink', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tieland', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'P J M', 'Initials': 'PJM', 'LastName': 'Weijs', 'Affiliation': 'Faculty of Sports and Nutrition, Center of Expertise Urban Vitality, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12838']
1898,33190372,Evaluation of the potential interference of camouflage on the treatment of vitiligo: an observer-blinded self-controlled study.,"BACKGROUND


Camouflage improves the quality of life in vitiligo patients. However, whether the use of camouflage interferes the efficacy of the treatment of vitiligo remains controversial.
OBJECTIVE


To evaluate the impact and safety of dihydroxyacetone (DHA)-containing camouflage on the treatment of vitiligo.
METHODS


30 patients were enrolled. Comparable vitiliginous patches in each patient were randomly divided into camouflage group or blank group. The therapeutic modalities including topical corticosteroids with or without NB-UVB phototherapy were applied to both groups of lesions. The outcomes were assessed at baseline and then every 4 weeks for up to 12 weeks, including types of repigmentation patterns, percentage of repigmentation, TEWL, and adverse events.
RESULTS


28 patients completed the study. There were no differences in repigmentation types and percentage of repigmentation at the endpoint of study between 2 groups. No difference in TEWL was found at the end of the study between the two groups. Temporary skin irritation (itching and tingling) occurred in one patient in camouflage group after phototherapy between 8-12 weeks' treatment.
CONCLUSIONS


DHA-containing camouflage is a safe make-up for vitiligo. It has little impact on the efficacy of the treatment of vitiligo or on the function of skin barrier. This article is protected by copyright. All rights reserved.",2020,There were no differences in repigmentation types and percentage of repigmentation at the endpoint of study between 2 groups.,"['30 patients were enrolled', '28 patients completed the study', 'vitiligo', 'vitiligo patients']","['topical corticosteroids with or without NB-UVB phototherapy', 'dihydroxyacetone (DHA)-containing camouflage']","['TEWL', 'types of repigmentation patterns, percentage of repigmentation, TEWL, and adverse events', 'repigmentation types and percentage of repigmentation', 'Temporary skin irritation (itching and tingling', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0012322', 'cui_str': 'Dihydroxyacetone'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",30.0,0.0252202,There were no differences in repigmentation types and percentage of repigmentation at the endpoint of study between 2 groups.,"[{'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qianxi', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}]",Dermatologic therapy,['10.1111/dth.14545']
1899,33190420,The effects of foot reflexology on blood pressure and heart rate: A randomized clinical trial in stage-2 hypertensive patients.,"Hypertension (HT) is a prominent cardiovascular risk factor. Although there are various pharmacological treatment choices for this condition, many patients fail to adhere to them, making non-pharmacological options attractive alternatives. Foot reflexology has been proven to decrease blood pressure (BP), but data are limited in patients with stage-2 HT. We conducted a randomized clinical trial to examine the effectiveness of foot reflexology in reducing BP and heart rate (HR). Stage-2 HT patients were enrolled and randomized into the intervention and the control groups (n = 47, each), the former of which underwent foot reflexology during a follow-up visit. Office BP and HR were measured before and at 15 and 30 min after the procedure in the intervention group and after resting in the control group. In the intervention group, systolic BP (SBP), diastolic BP (DBP), and HR at 15 min were significantly lower than at baseline: -3.29 mm Hg (95%CI; -5.64 to -0.93), -1.71 mm Hg (95%CI; -3.11 to -0.32), and -1.71 beats per min (bpm; 95%CI; -2.88 to -0.54), respectively. Similar trends were also observed at 30 min. However, when compared with the control group, only the reduction in HR was significant (-4.96 bpm; 95%CI, -9.63 to -0.28). We conclude that foot reflexology was effective in reducing HR in stage-2 HT patients and partially effective in reducing BP.",2020,"However, when compared with the control group, only the reduction in HR was significant (-4.96 bpm; 95%CI, -9.63 to -0.28).","['HT patients', 'patients with stage-2 HT', 'stage-2 HT patients', 'stage-2 hypertensive patients']",['foot reflexology'],"['Office BP and HR', 'blood pressure and heart rate', 'blood pressure (BP', 'reduction in HR', 'BP and heart rate (HR', 'systolic BP (SBP), diastolic BP (DBP), and HR at 15\xa0min', 'BP']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0676557,"However, when compared with the control group, only the reduction in HR was significant (-4.96 bpm; 95%CI, -9.63 to -0.28).","[{'ForeName': 'Praew', 'Initials': 'P', 'LastName': 'Kotruchin', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Supap', 'Initials': 'S', 'LastName': 'Imoun', 'Affiliation': 'Accident and Emergency Nursing Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thapanawong', 'Initials': 'T', 'LastName': 'Mitsungnern', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Patcharin', 'Initials': 'P', 'LastName': 'Aountrai', 'Affiliation': 'Accident and Emergency Nursing Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Maneenuch', 'Initials': 'M', 'LastName': 'Domthaisong', 'Affiliation': 'Accident and Emergency Nursing Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14103']
1900,33190513,Fast Foes: the physiological and behavioral consequences of interacting in an immersive negative social context.,"BACKGROUND AND OBJECTIVES


Social interactions involving personal disclosures are ubiquitous in social life and have important relational implications. A large body of research has documented positive outcomes from fruitful social interactions with amicable individuals, but less is known about how self-disclosing interactions with inimical interaction partners impacts individuals.
DESIGN AND METHODS


Participants engaged in an immersive social interaction task with a confederate (thought to be another participant) trained to behave amicably (Fast Friends) or inimically (Fast Foes). Cardiovascular responses were measured during the interaction and behavioral displays coded. Participants also reported on their subjective experiences of the interaction.
RESULTS


Participants assigned to interact in the Fast Foes condition reported more negative affect and threat appraisals, displayed more negative behaviors (i.e., agitation and anxiety), and exhibited physiological threat responses (and lower cardiac output in particular) compared to participants assigned to the Fast Friends condition.
CONCLUSIONS


The novel paradigm demonstrates differential stress and affective outcomes between positive and negative self-disclosure situations across multiple channels, providing a more nuanced understanding of the processes associated with disclosing information about the self in social contexts.",2020,"RESULTS


Participants assigned to interact in the Fast Foes condition reported more negative affect and threat appraisals, displayed more negative behaviors (i.e., agitation and anxiety), and exhibited physiological threat responses (and lower cardiac output in particular) compared to participants assigned to the Fast Friends condition.
",['Participants engaged in an immersive social interaction task with a confederate (thought to be another participant) trained to behave amicably (Fast Friends) or inimically (Fast Foes'],[],"['negative behaviors (i.e., agitation and anxiety), and exhibited physiological threat responses', 'Cardiovascular responses']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0154218,"RESULTS


Participants assigned to interact in the Fast Foes condition reported more negative affect and threat appraisals, displayed more negative behaviors (i.e., agitation and anxiety), and exhibited physiological threat responses (and lower cardiac output in particular) compared to participants assigned to the Fast Friends condition.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gordils', 'Affiliation': 'Department of Psychology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Jamieson', 'Affiliation': 'Department of Psychology, University of Rochester, Rochester, NY, USA.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1847275']
1901,33190659,Effects of repetitive paired associative stimulation on brain plasticity and working memory in Alzheimer's disease: a pilot randomized double-blind-controlled trial.,"DESIGN


Pilot randomized double-blind-controlled trial of repetitive paired associative stimulation (rPAS), a paradigm that combines transcranial magnetic stimulation (TMS) of the dorsolateral prefrontal cortex (DLPFC) with peripheral median nerve stimulation.
OBJECTIVES


To study the impact of rPAS on DLPFC plasticity and working memory performance in Alzheimer's disease (AD).
METHODS


Thirty-two patients with AD (females = 16), mean (SD) age = 76.4 (6.3) years were randomized 1:1 to receive a 2-week (5 days/week) course of active or control rPAS. DLPFC plasticity was assessed using single session PAS combined with electroencephalography (EEG) at baseline and on days 1, 7, and 14 post-rPAS. Working memory and theta-gamma coupling were assessed at the same time points using the N-back task and EEG.
RESULTS


There were no significant differences between the active and control rPAS groups on DLPFC plasticity or working memory performance after the rPAS intervention. There were significant main effects of time on DLPFC plasticity, working memory, and theta-gamma coupling, only for the active rPAS group. Further, on post hoc within-group analyses done to generate hypotheses for future research, as compared to baseline, only the rPAS group improved on post-rPAS day 1 on all three indices. Finally, there was a positive correlation between working memory performance and theta-gamma coupling.
CONCLUSIONS


This study did not show a beneficial effect of rPAS for DLPFC plasticity or working memory in AD. However, post hoc analyses showed promising results favoring rPAS and supporting further research on this topic. (Clinicaltrials.gov-NCT01847586).",2020,There were no significant differences between the active and control rPAS groups on DLPFC plasticity or working memory performance after the rPAS intervention.,"['Thirty-two patients with AD (females = 16), mean (SD) age = 76.4 (6.3) years', ""Alzheimer's disease (AD"", ""Alzheimer's disease""]","['rPAS', 'repetitive paired associative stimulation (rPAS', 'repetitive paired associative stimulation', 'transcranial magnetic stimulation (TMS', 'active or control rPAS']","['DLPFC plasticity or working memory performance', 'DLPFC plasticity, working memory, and theta-gamma coupling', 'brain plasticity and working memory', 'DLPFC plasticity']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C5200806', 'cui_str': 'Brain Plasticity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",32.0,0.409223,There were no significant differences between the active and control rPAS groups on DLPFC plasticity or working memory performance after the rPAS intervention.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Ghazala', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Goodman', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Corinne E', 'Initials': 'CE', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Pollock', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}]",International psychogeriatrics,['10.1017/S1041610220003518']
1902,33190679,Levetiracetam as an alternative to phenytoin for second-line emergency treatment of children with convulsive status epilepticus: the EcLiPSE RCT.,"BACKGROUND


Convulsive status epilepticus is the most common neurological emergency in children. Its management is important to avoid or minimise neurological morbidity and death. The current first-choice second-line drug is phenytoin (Epanutin, Pfizer Inc., New York, NY, USA), for which there is no robust scientific evidence.
OBJECTIVE


To determine whether phenytoin or levetiracetam (Keppra, UCB Pharma, Brussels, Belgium) is the more clinically effective intravenous second-line treatment of paediatric convulsive status epilepticus and to help better inform its management.
DESIGN


A multicentre parallel-group randomised open-label superiority trial with a nested mixed-method study to assess recruitment and research without prior consent.
SETTING


Participants were recruited from 30 paediatric emergency departments in the UK.
PARTICIPANTS


Participants aged 6 months to 17 years 11 months, who were presenting with convulsive status epilepticus and were failing to respond to first-line treatment.
INTERVENTIONS


Intravenous levetiracetam (40 mg/kg) or intravenous phenytoin (20 mg/kg).
MAIN OUTCOME MEASURES


Primary outcome - time from randomisation to cessation of all visible signs of convulsive status epilepticus. Secondary outcomes - further anticonvulsants to manage the convulsive status epilepticus after the initial agent, the need for rapid sequence induction owing to ongoing convulsive status epilepticus, admission to critical care and serious adverse reactions.
RESULTS


Between 17 July 2015 and 7 April 2018, 286 participants were randomised, treated and consented. A total of 152 participants were allocated to receive levetiracetam and 134 participants to receive phenytoin. Convulsive status epilepticus was terminated in 106 (70%) participants who were allocated to levetiracetam and 86 (64%) participants who were allocated to phenytoin. Median time from randomisation to convulsive status epilepticus cessation was 35 (interquartile range 20-not assessable) minutes in the levetiracetam group and 45 (interquartile range 24-not assessable) minutes in the phenytoin group (hazard ratio 1.20, 95% confidence interval 0.91 to 1.60;  p  = 0.2). Results were robust to prespecified sensitivity analyses, including time from treatment commencement to convulsive status epilepticus termination and competing risks. One phenytoin-treated participant experienced serious adverse reactions.
LIMITATIONS


First, this was an open-label trial. A blinded design was considered too complex, in part because of the markedly different infusion rates of the two drugs. Second, there was subjectivity in the assessment of 'cessation of all signs of continuous, rhythmic clonic activity' as the primary outcome, rather than fixed time points to assess convulsive status epilepticus termination. However, site training included simulated demonstration of seizure cessation. Third, the time point of randomisation resulted in convulsive status epilepticus termination prior to administration of trial treatment in some cases. This affected both treatment arms equally and had been prespecified at the design stage. Last, safety measures were a secondary outcome, but the trial was not powered to demonstrate difference in serious adverse reactions between treatment groups.
CONCLUSIONS


Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions. The results suggest that it may be an alternative to phenytoin in the second-line management of paediatric convulsive status epilepticus. Simple trial design, bespoke site training and effective leadership were found to facilitate practitioner commitment to the trial and its success. We provide a framework to optimise recruitment discussions in paediatric emergency medicine trials.
FUTURE WORK


Future work should include a meta-analysis of published studies and the possible sequential use of levetiracetam and phenytoin or sodium valproate in the second-line treatment of paediatric convulsive status epilepticus.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN22567894 and European Clinical Trials Database EudraCT number 2014-002188-13.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 58. See the NIHR Journals Library website for further project information.",2020,"CONCLUSIONS


Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions.","['Participants were recruited from 30 paediatric emergency departments in the UK', 'and 134 participants to receive', 'Between 17 July 2015 and 7 April 2018, 286 participants were randomised, treated and consented', 'Convulsive status epilepticus was terminated in 106 (70%) participants who were allocated to levetiracetam and 86 (64%) participants who were allocated to', 'Participants aged 6 months to 17 years 11 months, who were presenting with convulsive status epilepticus and were failing to respond to first-line treatment', 'A total of 152 participants', 'children', 'children with convulsive status epilepticus']","['intravenous phenytoin', 'Levetiracetam', 'Intravenous levetiracetam', 'levetiracetam and phenytoin or sodium valproate', 'levetiracetam', 'phenytoin or levetiracetam (Keppra, UCB Pharma, Brussels, Belgium', 'phenytoin']","[' time from randomisation to cessation of all visible signs of convulsive status epilepticus', 'convulsive status epilepticus, admission to critical care and serious adverse reactions', 'convulsive status epilepticus termination', 'convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions', 'serious adverse reactions', 'Median time from randomisation to convulsive status epilepticus cessation']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0876060', 'cui_str': 'Keppra'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",152.0,0.189183,"CONCLUSIONS


Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions.","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Appleton', 'Affiliation': ""The Roald Dahl Neurophysiology Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Naomi Ea', 'Initials': 'NE', 'LastName': 'Rainford', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shrouk', 'Initials': 'S', 'LastName': 'Messahel', 'Affiliation': ""Emergency Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Humphreys', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Woolfall', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roper', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Noblet', 'Affiliation': ""Emergency Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': ""Emergency Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tate', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Al Najjar', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Iyer', 'Affiliation': ""The Roald Dahl Neurophysiology Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Evans', 'Affiliation': 'Patient and public involvement representative, Wrexham, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Lyttle', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24580']
1903,33190843,Intranasal oxytocin versus placebo for hyperphagia and repetitive behaviors in children with Prader-Willi Syndrome: A randomized controlled pilot trial.,"OBJECTIVE


The effects of intranasal oxytocin and placebo on hyperphagia and repetitive behaviors were compared in children and adolescents with Prader Willi Syndrome (PWS).
METHODS


Children and adolescents with PWS were enrolled in an 8-week double-blind placebo-controlled intranasal oxytocin randomized trial. Twenty-three (23) subjects were assigned to oxytocin (N = 11) or placebo (N = 12). Hyperphagia was measured with the Hyperphagia Questionnaire (HQ), and repetitive behavior was measured with Repetitive Behavior Scale- Revised (RBS-R).
RESULTS


There were modest significant treatment by-time interactions indicating reduction in hyperphagia and repetitive behaviors across time for placebo but no reduction for oxytocin. Total HQ score showed a greater average reduction of 1.81 points/week for the placebo group vs. oxytocin, with maximum reduction at week 4. There were also greater reductions on HQ-Drive and HQ-Behavior subscales on placebo vs. oxytocin. RBS-R subscales followed similar patterns to the HQ, with a significantly greater reduction in sameness subscale behaviors (average 0.825 points/week) in the placebo group compared to the oxytocin group. Oxytocin was well tolerated, and the only adverse event that was both more common and possibly related to oxytocin vs. placebo was nocturia (n = 1 vs 0).
CONCLUSION


Placebo was associated with modest improvement in hyperphagia and repetitive behaviors in childhood PWS whereas intranasal oxytocin was not associated with improvement in these domains. More work is needed to understand the meaning and mechanism of these findings on hyperphagia and repetitive behaviors in PWS.",2020,Placebo was associated with modest improvement in hyperphagia and repetitive behaviors in childhood PWS whereas intranasal oxytocin was not associated with improvement in these domains.,"['children with Prader-Willi Syndrome', 'children and adolescents with Prader Willi Syndrome (PWS', 'Children and adolescents with PWS', 'Twenty-three (23) subjects']","['placebo-controlled intranasal oxytocin', 'oxytocin vs. placebo', 'intranasal oxytocin', 'oxytocin', 'intranasal oxytocin and placebo', 'placebo', 'Oxytocin', 'placebo vs. oxytocin', 'Placebo', 'Intranasal oxytocin']","['Repetitive Behavior', 'HQ-Drive and HQ-Behavior subscales', 'hyperphagia and repetitive behaviors', 'sameness subscale behaviors', 'Total HQ score', 'Hyperphagia', 'RBS-R subscales', 'Hyperphagia Questionnaire (HQ), and repetitive behavior']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032897', 'cui_str': 'Prader-Willi syndrome'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450348', 'cui_str': '23'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C1827547', 'cui_str': 'Repetitious behavior'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",23.0,0.462181,Placebo was associated with modest improvement in hyperphagia and repetitive behaviors in childhood PWS whereas intranasal oxytocin was not associated with improvement in these domains.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hollander', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA. Electronic address: eholland@montefiore.org.'}, {'ForeName': 'Kayla G', 'Initials': 'KG', 'LastName': 'Levine', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA.'}, {'ForeName': 'Casara J', 'Initials': 'CJ', 'LastName': 'Ferretti', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Freeman', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA; Biostatistics and Biomedical Sciences, Charles E. Schmidt College Medicine, Florida Atlantic University, and Extrapolate, Florida, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Doernberg', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA; Department of Psychology, Case Western University, Ohio, USA.'}, {'ForeName': 'Nilifa', 'Initials': 'N', 'LastName': 'Desilva', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA.'}, {'ForeName': 'Bonnie P', 'Initials': 'BP', 'LastName': 'Taylor', 'Affiliation': 'Autism and Obsessive Compulsive Spectrum Disorders Program, Psychiatric Research Institute of Montefiore Einstein (PRIME), Albert Einstein College of Medicine, New York, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.11.006']
1904,33190991,Development and validation of a multifrequency bioimpedance spectroscopy equation to predict appendicular skeletal muscle mass in hemodialysis patients.,"BACKGROUND & AIMS


The Body Composition Monitor (BCM), a multifrequency bioimpedance spectroscopy device, has been widely used to assess body composition in hemodialysis patients because its measurement is not affected by overhydration commonly seen in chronic kidney disease. We aimed to develop and validate an equation for obtaining appendicular skeletal muscle mass (ASM) from BCM taking dual-energy X-ray absorptiometry (DXA) as the reference among hemodialysis patients.
METHODS


A total of 322 consecutive body composition measurements with BCM and DXA in 263 hemodialysis patients were randomly divided at a ratio of 2:1 into development and validation groups. Stepwise multiple regression modeling was applied to develop the ASM prediction equation. We evaluated the model as a diagnostic tool for sarcopenia using cutoffs of ASM defined by the Asian Working Group for Sarcopenia (AWGS). We further explored the association between ASM predicted by the BCM equation and all-cause mortality in two independent cohorts: one with 326 stage 3-5 CKD patients and one with 629 hemodialysis patients.
RESULTS


BCM yielded the following equation: ASM (kg) = -1.838 + 0.395 × total body water (L) + 0.105 × body weight (kg) + 1.231 × male sex - 0.026 × age (years) (R 2  = 0.914, standard error of estimate = 1.35 kg). In the validation group, Bland-Altman reliability analysis showed no significant bias of 0.098 kg and limits of agreement ±2.440 kg. Using the AWGS criteria, the model was found to have a sensitivity of 94.1%, a specificity of 98.8%, a positive predictive value of 84.2%, and a negative predictive value of 99.6% for the diagnosis of sarcopenia. Low ASM predicted by the BCM equation was associated with significantly worse overall survival among CKD patients but not hemodialysis patients.
CONCLUSIONS


The new BCM equation provides a feasible and valid option for assessing ASM in hemodialysis patients.",2020,"In the validation group, Bland-Altman reliability analysis showed no significant bias of 0.098 kg and limits of agreement ±2.440 kg.","['629 hemodialysis patients', 'hemodialysis patients', '322 consecutive body composition measurements with BCM and DXA in 263 hemodialysis patients']","['multifrequency bioimpedance spectroscopy equation', 'BCM taking dual-energy X-ray absorptiometry (DXA']",['overall survival'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",263.0,0.0132507,"In the validation group, Bland-Altman reliability analysis showed no significant bias of 0.098 kg and limits of agreement ±2.440 kg.","[{'ForeName': 'Ting-Yun', 'Initials': 'TY', 'LastName': 'Lin', 'Affiliation': 'Division of Nephrology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, and School of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Ming-Ying', 'Initials': 'MY', 'LastName': 'Wu', 'Affiliation': ""Division of Renal Medicine, Department of Internal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan.""}, {'ForeName': 'Huan-Sheng', 'Initials': 'HS', 'LastName': 'Chen', 'Affiliation': 'Dialysis Center, An Hsin QingShui Clinic, Taichung, Taiwan.'}, {'ForeName': 'Szu-Chun', 'Initials': 'SC', 'LastName': 'Hung', 'Affiliation': 'Division of Nephrology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, and School of Medicine, Tzu Chi University, Hualien, Taiwan. Electronic address: szuchun.hung@gmail.com.'}, {'ForeName': 'Paik-Seong', 'Initials': 'PS', 'LastName': 'Lim', 'Affiliation': ""Division of Renal Medicine, Department of Internal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan; Department of Rehabilitation, Jenteh Junior College of Medicine, Nursing and Management, Miaoli, Taiwan. Electronic address: jamespslim@gmail.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.056']
1905,33191209,Building a Healthy Temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial.,"Diabetes self-management is key to preventing diabetes complications disproportionately affecting Hispanics. Church appears a promising setting for delivering a diabetes self-management education support (DSMES) program. ""Faith-placed"" (FP) programing refers to health interventions implemented in the church setting; while ""faith-based"" (FB) signifies integrating spirituality with health interventions. The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outcomes. This cluster-randomized trial tests the effectiveness of BHT DSMES by adapting an existing DSMES program into faith-based context. A total of 360 participants will be recruited from 18 churches (~20 participants/church). Churches will be randomly assigned to either the FB or FP intervention arm. Intervention activities will be implemented over 14 consecutive weeks. Participants in the FB arm will participate in BHT DSMES including a Health Sermon, the Self-Management Resource Center (SMRC) Diabetes Self-Management Program (DSMP), and a 7-session Healthy Bible Study, delivered by two trained church lay health leaders. Participants in the FP arm will attend the same SMRC DSMP facilitated by outside health professional, followed by a 7-session community health and safety curriculum as a partial attention control intervention. The primary outcome will be a change in Hemoglobin A1c (HbA1c) level. Secondary outcomes include: changes in body mass index, waist circumference, diabetes distress score, diabetes self-care behaviors, eating behavior, and physical activity level. Data will be collected at baseline, 6, 9, and 12 months during the study period. The proposed study will lead to innovative DSMES program delivery through faith settings for Hispanic persons with diabetes.",2020,The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outcomes.,"['Hispanic faith community settings', 'Participants in the FB arm will participate in BHT DSMES including a Health Sermon, the Self-Management Resource Center', '360 participants will be recruited from 18 churches (~20 participants/church', 'Hispanic persons with diabetes']","['FB or FP intervention', 'Healthy Temple diabetes self-management education support program', 'Faith-placed"" (FP', 'BHT DSMES']","[' changes in body mass index, waist circumference, diabetes distress score, diabetes self-care behaviors, eating behavior, and physical activity level', 'diabetic outcomes', 'change in Hemoglobin A1c (HbA1c) level']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376679', 'cui_str': 'Sermons'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",360.0,0.0399365,The Building a Health Temple (BHT) DSMES program integrates spirituality with DSMES to improve diabetic outcomes.,"[{'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Wilmoth', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Carrillo', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Correa', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States.'}, {'ForeName': 'Meixia', 'Initials': 'M', 'LastName': 'Pan', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Parra-Medina', 'Affiliation': 'The University of Texas at Austin, Department of Mexican American and Latina/o Studies, Austin, TX, United States.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sosa', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Reyes', 'Affiliation': 'Bandera Family Medical Group, San Antonio, TX, United States.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sass', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States.'}, {'ForeName': 'Meizi', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'The University of Texas at San Antonio, Department of Public Health, San Antonio, TX, United States. Electronic address: meizi.he@utsa.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106192']
1906,33191252,Embryo incubation by time-lapse systems versus conventional incubators in Chinese women with diminished ovarian reserve undergoing IVF/ICSI: a study protocol for a randomised controlled trial.,"INTRODUCTION


The time-lapse imaging system (TLS) is a newly developed non-invasive embryo assessment system. Compared with conventional incubators, a TLS provides stable culture conditions and consistent observations of embryo development, thereby potentially improving embryo quality and selection of the best quality embryo. Although TLSs have been routinely used in many in vitro fertilisation (IVF) centres globally, there is insufficient evidence to indicate that TLSs result in higher cumulative live birth rates over conventional incubators. The purpose of this study is to compare the cumulative live birth rates and safety including miscarriage in infertile patients with diminished ovarian reserve (DOR) from both TLSs and conventional incubators.
METHODS AND ANALYSIS


This study is a double-blind randomised controlled clinical trial (1:1 treatment ratio of TLSs vs conventional incubator). A total of 730 patients with DOR undergoing the first or second cycle of IVF or intracytoplasmic sperm injection (ICSI) will be enrolled and randomised into two parallel groups. Participants will undergo embryo culture in the TLSs (group A) or the conventional incubators (group B), respectively. Embryos are selected for transfer in both groups by the morphological characteristics. The embryo selection algorithm software is not used in the TLSs. The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation. This study is powered to detect an absolute difference of 10% (35% vs 25%) at the significance level of 0.05% and 80% statistical power based on a two-sided test.
ETHICS AND DISSEMINATION


This trial has been approved by the Institutional Ethical Committee of Shanghai First Maternity and Infant Hospital (KS1958). All participants in the trial will provide written informed consent. The study will be conducted according to the principles outlined in the Declaration of Helsinki and its amendments. Results of this study will be disseminated in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900027746).",2020,The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation.,"['Chinese women with diminished ovarian reserve undergoing', 'infertile patients with diminished ovarian reserve (DOR) from both TLSs and conventional incubators', '730 patients with DOR undergoing the first or second cycle of IVF or intracytoplasmic sperm injection (ICSI']","['IVF/ICSI', 'Embryo incubation by time-lapse systems versus conventional incubators', 'TLSs vs conventional incubator', 'conventional incubators']","['cumulative live birth rate of the trial IVF/ICSI cycle', 'cumulative live birth rates and safety including miscarriage', 'time-lapse imaging system (TLS']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1452561', 'cui_str': 'Democratic Republic of Timor-Leste'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C1452561', 'cui_str': 'Democratic Republic of Timor-Leste'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C2936618', 'cui_str': 'Time-Lapsed Imaging'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",730.0,0.448096,The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation.,"[{'ForeName': 'Miaoxin', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash Medical Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Ai', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chuanling', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kunming', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yonglun', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhiqin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Kong', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash Medical Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Teng', 'Affiliation': 'Centre for Reproductive Medicine, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China tengxiaoming@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038657']
1907,33191251,Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial.,"INTRODUCTION


Vasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60-65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years.
METHODS AND ANALYSIS


OVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation.
ETHICS AND DISSEMINATION


This protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums.
TRIAL REGISTRATION NUMBER


NCT03431181.",2020,"Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months).","['Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise', 'patients 65 years and older (OVATION-65) trial', '7 Canadian hospitals', 'Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12\u2009hours to maintain MAP ≥65\u2009mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours', 'hypotensive patients aged ≥65 years', 'patients 65 years and older']","['permissive hypotension (vasopressor titration to achieve MAP 60-65 mm Hg) versus usual care', 'permissive hypotension versus usual care']","['high-sensitivity troponin T, a biomarker of cardiac injury, on day 3', 'biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function', 'mean arterial pressure (MAP) targets']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0849925', 'cui_str': 'Ventricular failure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C2717957', 'cui_str': 'Vasoplegia'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",7.0,0.292856,"Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months).","[{'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Masse', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Battista', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Mary Elizabeth', 'Initials': 'ME', 'LastName': 'Wilcox', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruxandra', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marinoff', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Frédérick', 'Initials': 'F', 'LastName': ""D'Aragon"", 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'St-Arnaud', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mayette', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Leclair', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Quiroz Martinez', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Grondin-Beaudoin', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Department of Medicine, Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Élaine', 'Initials': 'É', 'LastName': 'Carbonneau', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Andrew J E', 'Initials': 'AJE', 'LastName': 'Seely', 'Affiliation': 'Departments of Surgery and Critical Care Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Watpool', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Porteous', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Chassé', 'Affiliation': 'Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Lebrasseur', 'Affiliation': ""Centre de recherche, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit, Centre de recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit, Centre de recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bellemare', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit, Centre de recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Charbonney', 'Affiliation': 'Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Émilie', 'Initials': 'É', 'LastName': 'Belley-Côté', 'Affiliation': 'Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Édouard', 'Initials': 'É', 'LastName': 'Botton', 'Affiliation': 'Patient partners, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Patient partners, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Centre de recherche, Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': 'Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada neill.adhikari@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-037947']
1908,33191260,ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis.,"INTRODUCTION


The many benefits of exercise for persons with multiple sclerosis (MS) are well established, yet patients often refrain from exercise due to overheating and exhaustion. The present randomised controlled trial tests aspirin (acetylsalicylic acid (ASA)) as a convenient method to prevent overheating and improve exercise performance in persons with MS. The effects of ASA are compared with those of acetaminophen (APAP) and placebo.
METHODS AND ANALYSIS


Participants are seen for a laboratory maximal exercise test on 3 separate days separated by at least 1 week. At each session, body temperature is measured before oral administration of a standard adult dose (650 mg) of ASA, APAP or placebo. One hour after drug administration, participants perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change. Crossover analyses will include tests for effects of treatment, period, treatment-period interaction (carryover effect) and sequence.
ETHICS AND DISSEMINATION


Ethical approval was granted by the institutional review board at Columbia University Irving Medical Center (reference: AAAS2529). Results of the trial will be published in peer-reviewed scientific journals and presented at national and international conferences. Neurologists, physiatrists, primary care physicians and physiotherapists are important stakeholders and will be targeted during dissemination. Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.
TRIAL REGISTRATION NUMBER


NCT03824938.",2020,"Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.
","['persons with MS', 'multiple sclerosis', 'persons with multiple sclerosis (MS']","['acetaminophen (APAP) and placebo', 'ASA', 'aspirin', 'ASA, APAP or placebo', 'aspirin (acetylsalicylic acid (ASA']","['a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change', 'exercise performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0005904', 'cui_str': 'Body Temperature Changes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.489021,"Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.
","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kever', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Nelson', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ines M', 'Initials': 'IM', 'LastName': 'Aguerre', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Riley', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Boehme', 'Affiliation': 'Department of Neurology and Epidemiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation and Regenerative Medicine, Columbia University Vangelos College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Strauss Farber', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Seth N', 'Initials': 'SN', 'LastName': 'Levin', 'Affiliation': 'Multiple Sclerosis Center, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Department of Rehabilitation and Regenerative Medicine, Columbia University Vangelos College of Physicians and Surgeons, New York, NY, USA.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Leavitt', 'Affiliation': 'Translational Cognitive Neuroscience Laboratory, Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA VL2337@cumc.columbia.edu.'}]",BMJ open,['10.1136/bmjopen-2020-039691']
1909,33191263,"Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial.","INTRODUCTION


About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).
METHODS AND ANALYSIS


Phase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm).
ETHICS AND DISSEMINATION


The clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.
TRIAL REGISTRATION NUMBER


NCT04357860.",2020,"If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.
","['hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level', 'adult patients with COVID-19 presenting cytokine release syndrome', 'patients with COVID-19 develop acute respiratory distress syndrome (ARDS', 'hospitalised adults with COVID-19 presenting cytokine release syndrome', '120 patients will be recruited (40 patients in each arm']","['sarilumab', 'sarilumab (an IL-6 receptor inhibitor', 'sarilumab (200 and 400\u2009mg) plus best available therapy (BAT']","['efficacy and safety', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948245', 'cui_str': 'Cytokine release syndrome'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.183448,"If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'León López', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Sheila Cárcel', 'Initials': 'SC', 'LastName': 'Fernández', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Limia Pérez', 'Affiliation': 'IMIBIC, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Romero Palacios', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario de Puerto Real, Puerto Real, Andalucía, Spain.'}, {'ForeName': 'María Concepción', 'Initials': 'MC', 'LastName': 'Fernández-Roldán', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario Virgen de las Nieves, Granada, Andalucía, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Aguilar Alonso', 'Affiliation': 'Intensive Care Unit, Hospital Infanta Margarita, Cabra, Andalucía, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Pérez Camacho', 'Affiliation': 'Infectious Diseases Unit, Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rodriguez-Baño', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario Virgen Macarena, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Merchante', 'Affiliation': 'Infectious Diseases and Microbiology Unit, Hospital Universitario Virgen de Valme, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Olalla', 'Affiliation': 'Internal Medicine Service, Hospital Costa del Sol, Marbella, Andalucía, Spain.'}, {'ForeName': 'M Ángeles', 'Initials': 'MÁ', 'LastName': 'Esteban-Moreno', 'Affiliation': 'Infectious Diseases Unit, Complejo Hospitalario Torrecardenas, Almeria, Andalucía, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Santos', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, Andalucía, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Luque-Pineda', 'Affiliation': 'Clinical Trials Unit, IMIBIC, Cordoba, Spain antonio.luque@imibic.org.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Torre-Cisneros', 'Affiliation': 'IMIBIC, Cordoba, Andalucía, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-039951']
1910,33191380,"[EFFICACY, SAFETY AND IMMUNOLOGICAL RESPONSE WITH SQ HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY-TABLET BY BODY WEIGHT IN CHILDREN].","BACKGROUND


Sublingual immunotherapy-tablet (SLIT-tablet) treatment includes the same dose regardless of the patients' age or body weight. We investigated the efficacy, safety and immunological response of SQ house dust mite (HDM) SLIT-tablet treatment in relation to body weight in children.
METHODS


Total combined rhinitis score (TCRS), adverse events (AEs), adverse drug reactions (ADRs) and immunological response (IgE, IgG4) were evaluated post hoc in three subgroups (body weight < 30kg, 30-44kg, ≥ 45kg) of patients from a clinical trial for Japanese children with HDM allergic rhinitis (JapicCTI-152953).
RESULTS


No apparent differences in TCRS were observed between the three subgroups. No differences in the frequency or nature of AEs were detected between the subgroups but the incidence of ADRs was decreased in the lower body weight subgroup. The most common ADRs occurred locally in the oral cavity and were categorized as mild. The levels of HDM specific IgE and IgG4 were increased compared to baseline in all subgroups.
CONCLUSION


There were no influences of body weight for efficacy, safety, and immunological response in treatment with SQ HDM SLIT-tablet. These results indicated that SLIT dosage in children is same as adults without any concern in safety.",2020,No differences in the frequency or nature of AEs were detected between the subgroups but the incidence of ADRs was decreased in the lower body weight subgroup.,"['children', ""patients' age or body weight"", 'Japanese children with HDM allergic rhinitis (JapicCTI-152953']","['Sublingual immunotherapy-tablet (SLIT-tablet', 'SLIT', 'SQ house dust mite (HDM) SLIT-tablet treatment']","['levels of HDM specific IgE and IgG4', 'rhinitis score (TCRS), adverse events (AEs), adverse drug reactions (ADRs) and immunological response (IgE, IgG4', 'incidence of ADRs', 'TCRS', 'efficacy, safety and immunological response', 'body weight for efficacy, safety, and immunological response', 'frequency or nature of AEs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1270515', 'cui_str': 'House dust mite (Bt) specific immunoglobulin E'}, {'cui': 'C0020860', 'cui_str': 'Immunoglobulin IgG4'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0349590', 'cui_str': 'Nature'}]",,0.030769,No differences in the frequency or nature of AEs were detected between the subgroups but the incidence of ADRs was decreased in the lower body weight subgroup.,"[{'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Torii Pharmaceutical Co., Ltd.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Torii Pharmaceutical Co., Ltd.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Asaumi', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Yanagida', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Azuma', 'Affiliation': 'Torii Pharmaceutical Co., Ltd.'}, {'ForeName': 'Katsuyo', 'Initials': 'K', 'LastName': 'Ohashi-Doi', 'Affiliation': 'Torii Pharmaceutical Co., Ltd.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital.'}]",Arerugi = [Allergy],['10.15036/arerugi.69.918']
1911,33191392,1-Year Safety of 3-Month Dual Antiplatelet Therapy Followed by Aspirin or P2Y 12  Receptor Inhibitor Monotherapy Using a Bioabsorbable Polymer Sirolimus-Eluting Stent.,"BACKGROUND


This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2Y 12 inhibitor with aspirin monotherapy 3 months after DAPT.Methods and Results:Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year. Patients with a history of stent thrombosis were excluded. The primary endpoint was a composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding at 12 months. The BP-SES arm of the CENTURY II trial was used as a conventional DAPT group for comparison. After DAPT, patients were maintained on either aspirin (n=846) or a P2Y 12 inhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers. The primary endpoint occurred in 4.3% of patients at 1 year. After propensity score adjustment, the incidence of the primary endpoint was not inferior in those receiving DAPT for 3 months compared with conventional DAPT (5.5%; P non-inferiority <0.0001). The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Y 12 inhibitor monotherapy groups.
CONCLUSIONS


After adjustment, 3-month DAPT was not inferior to longer DAPT after BP-SES implantation in terms of net adverse clinical events. There was no difference in bleeding and thrombotic events between P2Y 12 inhibitor and aspirin monotherapy after 3 months DAPT.",2020,"The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Y 12 inhibitor monotherapy groups.
","['n=846) or a P2Y 12 inhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers', 'Patients with a history of stent thrombosis were excluded', 'Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year']","['sirolimus-eluting stent (BP-SES', 'conventional DAPT', 'dual antiplatelet therapy (DAPT', 'Aspirin or P2Y 12  Receptor Inhibitor Monotherapy', 'aspirin', 'Bioabsorbable Polymer Sirolimus-Eluting Stent']","['severe bleeding', 'bleeding and thrombotic events', 'composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding']","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",1695.0,0.0726799,"The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Y 12 inhibitor monotherapy groups.
","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Cardiology, Toyohashi Heart Center.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Hioki', 'Affiliation': 'Department of Cardiology, Teikyo University.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Nanasato', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiology, Saiseikai Yokohamashi Tobu Hospital.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University.""}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Shiode', 'Affiliation': 'Department of Cardiology, Hiroshima City Hiroshima Citizens Hospital.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiology, Kitazato University Hospital.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Department of Cardiology, Iwate Medical University.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirohata', 'Affiliation': 'Department of Cardiology, The Sakakibara Heart Institute of Okayama.'}, {'ForeName': 'Shinjo', 'Initials': 'S', 'LastName': 'Sonoda', 'Affiliation': 'Department of Cardiology, Hospital of the University of Occupational and Environmental Health.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiology, Shiga University of Medical Science Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University Hospital.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0644']
1912,33191408,A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer.,"BACKGROUND


This study compared the efficacy/safety of the camptothecin analogues belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC).
METHODS


One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m 2 ) or belotecan (0.5 mg/m 2 ), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint.
RESULTS


In the belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% (p = 0.09) and DCR was 85% vs. 70% (p = 0.030). PFS was not different between groups. Median OS was significantly longer with belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48-0.99), particularly in patients aged <65 years, with more advanced disease (i.e., extensive-stage disease, time to relapse: 3-6 months), or Eastern Cooperative Oncology Group performance status 1 or 2. More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022).
CONCLUSIONS


The efficacy/safety of belotecan warrants further evaluation in Phase 3 trials. Belotecan potentially offers an alternative to topotecan for sensitive-relapsed SCLC, particularly in patients aged <65 years, with more advanced disease, or poor performance.",2020,"More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022).
","['sensitive-relapsed small-cell lung cancer', 'patients aged <65 years, with more advanced disease, or poor performance', 'One-hundred-and-sixty-four patients']","['topotecan', 'belotecan vs. topotecan', 'camptothecin analogues belotecan and topotecan', 'belotecan']","['efficacy/safety', 'DCR', 'efficacy and safety', 'ORR', 'objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity', 'PFS', 'Median OS']","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0762737', 'cui_str': 'belotecan'}, {'cui': 'C0006812', 'cui_str': 'Camptothecin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",164.0,0.129079,"More belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022).
","[{'ForeName': 'Jin-Hyoung', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ""The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Ki-Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Cheongju, South Korea.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Division of Medical Oncology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joo-Hang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'CHA University Bundang Medical Center, Seongnam, South Korea.'}, {'ForeName': 'Jin-Hyuk', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'Ho Jung', 'Initials': 'HJ', 'LastName': 'An', 'Affiliation': ""The Catholic University of Korea St. Vincent's Hospital, Seoul, South Korea.""}, {'ForeName': 'Jin-Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Joung-Soon', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bong-Seog', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Veterans Health Service Medical Center, Seoul, South Korea.'}, {'ForeName': 'Heung Tae', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'National Cancer Center, Goyang, South Korea. htkim@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-020-01055-5']
1913,33191450,Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study.,"PURPOSE


To investigate the efficacy and safety of nab-paclitaxel plus S-1 (nab-P/S) versus nab-paclitaxel plus gemcitabine (nab-P/G) as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
METHODS


Treatment-naïve patients with advanced PDAC were equally randomized to receive nab-P/S or nab-P/G. The primary endpoint was the objective response rate (ORR). The secondary endpoints were ORR of the primary lesion, disease control rate, progression-free survival (PFS), overall survival (OS) and safety. The trial was registered at https://clinicaltrials.gov as NCT03636308.
RESULTS


A total of 110 patients were planned for enrollment, but the trial was prematurely closed because no better ORR was observed with nab-P/S among the first 40 patients assigned between 08/2018 and 06/2019. The ORR was numerically higher with nab-P/S versus nab-P/G (35.0% vs 25.0%, P = 0.49). The ORRs of the primary lesion for both arms were similar (30.0% and 25.0%, P = 0.72). Disease control rate was 70.0% in each arm. There was no significant difference in PFS and OS between the two arms (median PFS, 6.3 vs 5.7 months, P = 0.34; median OS, 10.2 vs 10.2 months, P = 0.92). Risks of hematological toxicity, liver injury and rash were significantly decreased in the nab-P/S arm.
CONCLUSIONS


A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile. It may be a promising and convenient alternative as first-line and neoadjuvant settings for advanced PDAC.",2020,A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile.,"['Treatment-naïve patients with advanced PDAC', '110 patients', 'patients with advanced pancreatic ductal adenocarcinoma', 'patients with advanced pancreatic ductal adenocarcinoma (PDAC']","['nab-P/S or nab-P/G', 'nab-paclitaxel plus S-1 (nab-P/S) versus nab-paclitaxel plus gemcitabine (nab-P/G', 'Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine']","['objective response rate (ORR', 'ORR of the primary lesion, disease control rate, progression-free survival (PFS), overall survival (OS) and safety', 'efficacy and safety', 'ORR', 'Disease control rate', 'safety profile', 'PFS and OS', 'ORRs of the primary lesion', 'Risks of hematological toxicity, liver injury and rash']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",110.0,0.166564,A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile.,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zong', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Xicheng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China. 13366152815@126.com.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03442-0']
1914,33191484,A Novel Nomogram and Risk Classification System Predicting the Cancer-Specific Mortality of Patients with Initially Diagnosed Metastatic Cutaneous Melanoma.,"BACKGROUND


Cutaneous melanoma and distant organ metastasis has varying outcomes. Considering all prognostic indicators in a prediction model might assist in selecting cases who could benefit from a personalized therapy strategy.
OBJECTIVE


This study aimed to develop and validate a prognostic model for patients with metastatic melanoma.
METHODS


A total of 1535 cases diagnosed with metastatic cutaneous melanoma (stage IV) were identified from the Surveillance, Epidemiology, and End Results database. Patients were randomly divided into the training (n = 1023) and validation (n = 512) cohorts. A prognostic nomogram was established based predominantly on results from the competing-risk regression model for predicting cancer-specific death (CSD). The area under the time-dependent receiver operating characteristic curve (AUC), calibration curves, and decision curve analyses (DCAs) were used to evaluate the nomogram.
RESULTS


No significant differences were observed in the clinical characteristics between the training and validation cohorts. In the training cohort, patient-, tumor-, and treatment-related predictors of CSD for metastatic melanoma included age, sex, race, marital status, insurance, American Joint Committee on Cancer T and N stage, number of metastatic organs, surgical treatment, and chemotherapy. All these factors were used for nomogram construction. The time-dependent AUC values of the training and validation cohorts suggested a favorable performance and discrimination of the nomogram. The 6-, 12-, and 18-month AUC values were 0.706, 0.700, and 0.706 in the training cohort, and 0.702, 0.670, and 0.656 in the validation cohort, respectively. The calibration curves for the probability of death at 6, 12, and 18 months showed acceptable agreement between the values predicted by the nomogram and the observed outcomes in both cohorts. DCA curves showed good positive net benefits in the prognostic model among most of the threshold probabilities at different time points (death at 6, 12, and 18 months). Based on the total nomogram scores of each case, all patients were divided into the low-risk (n = 511), intermediate-risk (n = 512), and high-risk (n = 512) groups, and the risk classification could identify cases with a high risk of death in both cohorts.
CONCLUSIONS


A predictive nomogram and a corresponding risk classification system for CSD in patients with metastatic melanoma were developed in this study, which may assist in patient counseling and in guiding clinical decision making for cases with metastatic melanoma.",2020,"The calibration curves for the probability of death at 6, 12, and 18 months showed acceptable agreement between the values predicted by the nomogram and the observed outcomes in both cohorts.","['patients with metastatic melanoma', '1535 cases diagnosed with metastatic cutaneous melanoma (stage IV', 'cases with metastatic melanoma', 'Patients with Initially Diagnosed Metastatic Cutaneous Melanoma']",['DCA'],"['area under the time-dependent receiver operating characteristic curve (AUC), calibration curves, and decision curve analyses (DCAs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0037501', 'cui_str': 'Sodium Dichloroacetate'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}]",1535.0,0.0449753,"The calibration curves for the probability of death at 6, 12, and 18 months showed acceptable agreement between the values predicted by the nomogram and the observed outcomes in both cohorts.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Plastic and Burns Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Plastic and Burns Surgery, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Plastic and Burns Surgery, West China Hospital, Sichuan University, Chengdu, China. xxw_0826@163.com.'}, {'ForeName': 'Yange', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Plastic and Burns Surgery, West China Hospital, Sichuan University, Chengdu, China. zhangyange7801@163.com.'}]",Annals of surgical oncology,['10.1245/s10434-020-09341-5']
1915,33191522,Prospective randomized comparison between upgraded '2C3L' vs. PVI approach for catheter ablation of persistent atrial fibrillation: PROMPT-AF trial design.,"BACKGROUND


In randomized studies, the strategy of pulmonary vein (PV) antral isolation (PVI) plus linear ablation has failed to increase success rates for persistent atrial fibrillation (PeAF) ablation when compared with PVI alone. Peri-mitral reentry related atrial tachycardia due to incomplete linear block is an important cause of clinical failures of a first ablation procedure. Ethanol infusion (EI) into the vein of Marshall (EI-VOM) has been demonstrated to facilitate a durable mitral isthmus linear lesion.
OBJECTIVE


This trial is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
STUDY DESIGN


The PROMPT-AF study is a prospective, multicenter, randomized trial involving blinded assessment of outcomes. Patients (n = 276) undergoing their first catheter ablation of PeAF will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavo-tricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).
CONCLUSIONS


The PROMPT-AF study will evaluate the efficacy of the fixed '2C3L' approach in conjunction with EI-VOM, compared with PVI alone, in patients with PeAF undergoing de novo ablation. This article is protected by copyright. All rights reserved.",2020,Peri-mitral reentry related atrial tachycardia due to incomplete linear block is an important cause of clinical failures of a first ablation procedure.,"['Patients (n = 276) undergoing their first catheter ablation of PeAF', 'patients with PeAF undergoing de novo ablation', 'catheter ablation of persistent atrial fibrillation']","['pulmonary vein (PV) antral isolation (PVI) plus linear ablation', ""upgraded '2C3L' vs. PVI approach"", ""upgraded '2C3L' arm or PVI"", 'Ethanol infusion (EI) into the vein of Marshall (EI-VOM']","['rate of documented atrial tachycardia arrhythmias of >30 seconds, without any antiarrhythmic drugs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]","[{'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}]",276.0,0.0534986,Peri-mitral reentry related atrial tachycardia due to incomplete linear block is an important cause of clinical failures of a first ablation procedure.,"[{'ForeName': 'Xiao-Xia', 'Initials': 'XX', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Cai-Hua', 'Initials': 'CH', 'LastName': 'Sang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'De-Yong', 'Initials': 'DY', 'LastName': 'Long', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bai', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chen-Xi', 'Initials': 'CX', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ri-Bo', 'Initials': 'RB', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xue-Yuan', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Song-Nan', 'Initials': 'SN', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hai-Long', 'Initials': 'HL', 'LastName': 'Tao', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Ying-Wei', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Chen-Yang', 'Initials': 'CY', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jin-Lin', 'Initials': 'JL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Wuhan Asian Heart Hospital, Wuhan, China.'}, {'ForeName': 'Yu-Mei', 'Initials': 'YM', 'LastName': 'Xue', 'Affiliation': ""Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yi-Qiang', 'Initials': 'YQ', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, Henan Provincial Chest Hospital, Zhengzhou, China.'}, {'ForeName': 'Shao-Long', 'Initials': 'SL', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Yun-Nan St. John Cardiology Hospital, Kunming, China.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Mao', 'Affiliation': 'Department of Cardiology, Union Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shang-Ming', 'Initials': 'SM', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital, Jinan, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Taizhou Hospital of Zhejiang Province, Taizhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Department of Cardiology, Xinqiao Hospital, The Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Zhi-Bing', 'Initials': 'ZB', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Dong-Xian', 'Initials': 'DX', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Cheng-Long', 'Initials': 'CL', 'LastName': 'Miao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Hebei University, Shijiazhuang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Zeng', 'Initials': 'JZ', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chang-Sheng', 'Initials': 'CS', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14118']
1916,33191527,Prior exercise enhances skeletal muscle microvascular blood flow and mitigates microvascular flow impairments induced by a high-glucose mixed meal in healthy young men.,"KEY POINTS


Exercise, insulin-infusion and low-glucose mixed-nutrient meal ingestion increases muscle microvascular blood flow which in part facilitates glucose delivery and disposal. In contrast, high-glucose ingestion impairs muscle microvascular blood flow which may contribute to impaired postprandial metabolism. We investigated the effects of prior cycling exercise on postprandial muscle microvascular blood flow responses to a high-glucose mixed-nutrient meal ingested 3 and 24 h post-exercise. Prior exercise enhanced muscle microvascular blood flow and mitigated microvascular impairments induced by a high-glucose mixed meal ingested 3 h post-exercise, and to a lesser extent 24 h post-exercise. High-glucose ingestion 3 h post-exercise leads to greater postprandial blood glucose, non-esterified fatty acids, and fat oxidation, and a delay in the insulin response to the meal compared to control. Effects of acute exercise on muscle microvascular blood flow persist well after the cessation of exercise which may be beneficial for conditions characterized by microvascular and glycaemic dysfunction.
ABSTRACT


Exercise, insulin-infusion and low-glucose mixed-nutrient meal ingestion lead to increased muscle microvascular blood flow (MBF), whereas high-glucose ingestion impairs MBF. We investigated whether prior cycling exercise could enhance postprandial muscle MBF and prevent MBF impairments induced by high-glucose mixed-nutrient meal ingestion. In a randomized cross-over design, eight healthy young men ingested a high-glucose mixed-nutrient meal (1.1 g glucose/kg body weight; 45% carbohydrate, 20% protein and 35% fat) after an overnight fast (no-exercise control) and 3 h and 24 h after moderate-intensity cycling exercise (1 h at 70-75%    V   ̇   O   2   peak      ). Skeletal muscle MBF, measured directly by contrast-enhanced ultrasound, was lower at 60 min and 120 min postprandially compared to baseline in all conditions (P < 0.05), with a greater decrease occurring from 60 min to 120 min in the control (no-exercise) condition only (P < 0.001). Despite this meal-induced decrease, MBF was still markedly higher compared to control in the 3 h post-exercise condition at 0 min (pre-meal; 74%, P = 0.004), 60 min (112%, P = 0.002) and 120 min (223%, P < 0.001), and in the 24 h post-exercise condition at 120 min postprandially (132%, P < 0.001). We also report that in the 3 h post-exercise condition postprandial blood glucose, non-esterified fatty acids (NEFAs), and fat oxidation were substantially elevated, and the insulin response to the meal delayed compared to control. This probably reflects a combination of increased post-exercise exogenous glucose appearance, substrate competition, and NEFA-induced insulin resistance. We conclude that prior cycling exercise elicits long-lasting effects on muscle MBF and partially mitigates MBF impairments induced by high-glucose mixed-nutrient meal ingestion.",2020,"Skeletal muscle MBF, measured directly by contrast-enhanced ultrasound, was lower at 60 min and 120 min postprandially compared to baseline in all conditions (P ","['eight healthy young men ingested a high-glucose mixed-nutrient meal (1.1\xa0g glucose/kg body weight; 45% carbohydrate, 20% protein and 35% fat) after an', 'healthy young men']","['prior cycling exercise', 'overnight fast (no-exercise control) and 3\xa0h and 24\xa0h after moderate-intensity cycling exercise (1\xa0h at 70-75%    V   ̇', 'High-glucose ingestion 3\xa0h post-exercise', 'acute exercise']","['postprandial blood glucose, non-esterified fatty acids, and fat oxidation', 'postprandial muscle MBF and prevent MBF impairments', 'muscle microvascular blood flow and mitigated microvascular impairments', 'postprandial muscle microvascular blood flow responses', 'muscle microvascular blood flow', 'muscle microvascular blood flow (MBF', 'exercise condition postprandial blood glucose, non-esterified fatty acids (NEFAs), and fat oxidation', 'Skeletal muscle MBF', 'MBF']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",8.0,0.0190199,"Skeletal muscle MBF, measured directly by contrast-enhanced ultrasound, was lower at 60 min and 120 min postprandially compared to baseline in all conditions (P ","[{'ForeName': 'Lewan', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Morrison', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Wadley', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Shaw', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Betik', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Roberts-Thomson', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Gunveen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Keske', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}]",The Journal of physiology,['10.1113/JP280651']
1917,33191588,Extended RAS Analysis of the Phase 3 EPIC Trial: Irinotecan + Cetuximab vs Irinotecan as Second-Line Treatment for Patients with Metastatic Colorectal Cancer.,"BACKGROUND


The multicenter, open-label, randomized, phase 3 EPIC study (EMR 062202-025) investigated cetuximab plus irinotecan vs irinotecan in patients with epidermal growth factor receptor-detectable metastatic colorectal cancer (mCRC) that progressed on first-line fluoropyrimidine- and oxaliplatin-based chemotherapy; we report the outcomes of patients with RAS-wild-type (wt) disease.
MATERIALS AND METHODS


Available DNA samples from RAS-unselected patients (n = 1164 of 1298 [89.7%]) were reanalyzed for RAS mutations using BEAMing. Baseline characteristics, efficacy, safety, and post-study therapy were assessed. RAS-wt status was defined as a mutated RAS allele frequency of ≤5%, with all relevant alleles being analyzable.
RESULTS


Baseline characteristics were comparable between the groups (N = 452 patients with RAS-wt mCRC; cetuximab plus irinotecan n = 231, irinotecan n = 221) and between the RAS-wt and RAS-unselected populations. In the cetuximab plus irinotecan vs irinotecan arms, median overall survival was 12.3 vs 12.0 months, median progression-free survival (PFS) was 5.4 vs 2.6 months, and objective response rate (ORR) was 29.4% vs 5.0%, respectively. Quality of life (QoL) was improved in the cetuximab plus irinotecan arm. Serious adverse events occurred in 45.4% (cetuximab plus irinotecan) and 42.4% (irinotecan) of patients. In total, 47.1% of patients in the irinotecan arm received subsequent cetuximab therapy.
CONCLUSION


PFS, ORR, and QoL were improved with cetuximab plus irinotecan as a second-line treatment in patients with RAS-wt mCRC, confirming that cetuximab-based therapy is suitable in this population. Almost half of patients in the irinotecan arm received post-study cetuximab, masking a potential OS benefit of cetuximab addition.
IMPLICATIONS FOR PRACTICE


Cetuximab is approved for the treatment of RAS-wild-type metastatic colorectal cancer (mCRC). In this retrospective analysis of the phase 3 EPIC study (cetuximab plus irinotecan versus irinotecan alone as second-line treatment in patients with RAS-unselected mCRC), the subgroup of patients with RAS-wild-type mCRC who received cetuximab plus irinotecan had improved progression-free survival, objective response rate, and quality of life compared with the RAS-unselected population. These findings suggest that cetuximab-based therapy is a suitable second-line treatment for patients with RAS-wild-type mCRC.",2020,Serious adverse events occurred in 45.4% (cetuximab plus irinotecan) and 42.4% (irinotecan) of patients.,"['RAS-wild-type metastatic colorectal cancer (mCRC', 'patients with RAS-wild-type (wt) disease', 'Patients with Metastatic Colorectal Cancer', 'Available DNA samples from RAS-unselected patients (n =\u20091164 of 1298 [89.7%]) were reanalyzed for RAS mutations using BEAMing', 'patients with RAS-wild-type mCRC', 'patients with RAS-unselected mCRC), the subgroup of patients with RAS-wild-type mCRC who received', 'patients with epidermal growth factor receptor-detectable metastatic colorectal cancer (mCRC']","['fluoropyrimidine- and oxaliplatin-based chemotherapy', 'cetuximab-based therapy', 'subsequent cetuximab therapy', 'Irinotecan + Cetuximab vs Irinotecan', 'cetuximab plus irinotecan versus irinotecan', 'cetuximab plus irinotecan vs irinotecan', 'cetuximab plus irinotecan', 'irinotecan']","['objective response rate (ORR', 'median progression-free survival (PFS', 'Quality of life (QoL', 'Serious adverse events', 'Baseline characteristics, efficacy, safety, and post-study therapy', 'median overall survival', 'progression-free survival, objective response rate, and quality of life']","[{'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",452.0,0.0455743,Serious adverse events occurred in 45.4% (cetuximab plus irinotecan) and 42.4% (irinotecan) of patients.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'IRCCS San Martino Policlínico, Genoa, Italy.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Eng', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Merck Serono China, Beijing, China.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Esser', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Nippgen', 'Affiliation': 'Merck Serono China, Beijing, China.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Burris', 'Affiliation': 'Tennessee Oncology Sarah Cannon Research Institute, Nashville, USA.'}]",The oncologist,['10.1002/onco.13591']
1918,33191598,The antidepressant hoax: Conspiracy theories decrease health-seeking intentions.,"Health-related conspiracy theories can undermine the trustworthiness of actors and institutions and may impact an individual's intention to seek help. Across three experimental studies, we investigated the consequences of exposure to an antidepressant conspiracy theory on general intentions to seek medical and psychological help. Study 1 participants (N = 299) were randomly allocated to read one of three articles (pro-conspiracy, anti-conspiracy, control) after which they completed measures of conspiracy endorsement, trust, powerlessness, and health-seeking intentions. Results suggested that exposure to antidepressant conspiracy theories significantly reduced individual's intention to seek help indirectly through decreased trust in health authorities, but not health-industry-related powerlessness. In two additional pre-registered studies, we found some support for these findings. While Study 2 (N = 244) found no support for a direct or indirect relationship between conspiracy exposure and health-seeking intentions, an exploratory analysis highlighted the importance of gender differences when investigating conspiracy exposure on intentions. Study 3 (N = 247) replicated Study 1 findings, highlighting that antidepressant conspiracy theories decrease health-seeking intentions indirectly through decreased trust and increased powerlessness. Mere exposure to antidepressant conspiracy theories had significant indirect consequences on general health-seeking intentions.",2020,Mere exposure to antidepressant conspiracy theories had significant indirect consequences on general health-seeking intentions.,['Study 1 participants (N\xa0=\xa0299'],[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],[],299.0,0.015111,Mere exposure to antidepressant conspiracy theories had significant indirect consequences on general health-seeking intentions.,"[{'ForeName': 'Eleanor E', 'Initials': 'EE', 'LastName': 'Natoli', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Marques', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}]",The British journal of social psychology,['10.1111/bjso.12426']
1919,33191629,Cardiac adaptations to 60 day head-down-tilt bed rest deconditioning. Findings from the AGBRESA study.,"AIMS


Reduced physical activity increases the risk of heart failure; however, non-invasive methodologies detecting subclinical changes in myocardial function are not available. We hypothesized that myocardial, left ventricular, systolic strain measurements could capture subtle abnormalities in myocardial function secondary to physical inactivity.
METHODS AND RESULTS


In the AGBRESA study, which assessed artificial gravity through centrifugation as potential countermeasure for space travel, 24 healthy persons (eight women) were submitted to 60 day strict -6° head-down-tilt bed rest. Participants were assigned to three groups of eight subjects: a control group, continuous artificial gravity training on a short-arm centrifuge (30 min/day), or intermittent centrifugation (6 × 5 min/day). We assessed cardiac morphology, function, strain, and haemodynamics by cardiac magnetic resonance imaging (MRI) and echocardiography. We observed no differences between groups and, therefore, conducted a pooled analysis. Consistent with deconditioning, resting heart rate (∆8.3 ± 6.3 b.p.m., P < 0.0001), orthostatic heart rate responses (∆22.8 ± 19.7 b.p.m., P < 0.0001), and diastolic blood pressure (∆8.8 ± 6.6 mmHg, P < 0.0001) increased, whereas cardiac output (∆-0.56 ± 0.94 L/min, P = 0.0096) decreased during bed rest. Left ventricular mass index obtained by MRI did not change. Echocardiographic left ventricular, systolic, global longitudinal strain (∆1.8 ± 1.83%, P < 0.0001) decreased, whereas left ventricular, systolic, global MRI circumferential strain increased not significantly (∆-0.68 ± 1.85%, P = 0.0843). MRI values rapidly returned to baseline during recovery.
CONCLUSION


Prolonged head-down-tilt bed rest provokes changes in cardiac function, particularly strain measurements, that appear functional rather than mediated through cardiac remodelling. Thus, strain measurements are of limited utility in assessing influences of physical deconditioning or exercise interventions on cardiac function.",2020,"Echocardiographic left ventricular, systolic, global longitudinal strain (∆1.8 ± 1.83%, P < 0.0001) decreased, whereas left ventricular, systolic, global MRI circumferential strain increased not significantly (∆-0.68 ± 1.85%, P = 0.0843).",['24 healthy persons (eight women'],"['control group, continuous artificial gravity training on a short-arm centrifuge (30\xa0min/day), or intermittent centrifugation']","['left ventricular, systolic, global MRI circumferential strain', 'orthostatic heart rate responses', 'cardiac output', 'Echocardiographic left ventricular, systolic, global longitudinal strain', 'MRI values', 'resting heart rate (∆8.3\xa0±', 'cardiac morphology, function, strain, and haemodynamics by cardiac magnetic resonance imaging (MRI) and echocardiography', 'diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0179834', 'cui_str': 'Centrifuge'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",24.0,0.105413,"Echocardiographic left ventricular, systolic, global longitudinal strain (∆1.8 ± 1.83%, P < 0.0001) decreased, whereas left ventricular, systolic, global MRI circumferential strain increased not significantly (∆-0.68 ± 1.85%, P = 0.0843).","[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Hoffmann', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Rabineau', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Mehrkens', 'Affiliation': 'Department of Internal Medicine III, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Darius A', 'Initials': 'DA', 'LastName': 'Gerlach', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Moestl', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Bernd W', 'Initials': 'BW', 'LastName': 'Johannes', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Enrico G', 'Initials': 'EG', 'LastName': 'Caiani', 'Affiliation': 'Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Pierre Francois', 'Initials': 'PF', 'LastName': 'Migeotte', 'Affiliation': 'LPHYS, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Head of the Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}]",ESC heart failure,['10.1002/ehf2.13103']
1920,33191656,The relationship of sleep duration and quality to energy expenditure and physical activity in children.,"BACKGROUND


Shorter sleep duration has been linked to the risk for obesity in children. The pathways linking sleep duration and quality to the risk of obesity are unclear, particularly the effect of sleep on energetics.
OBJECTIVE


We investigated the relationship between sleep duration, quality and timing in children, to the basal metabolic rate (BMR), total energy expenditure (TEE) and physical activity (PA).
METHODS


Fifty nine children in two age-groups (5-11 and 12-18 years) underwent evaluation of body composition (DXA), BMR in a room calorimeter, free-living TEE by doubly labelled water method, sleep and PA (7-day Actiheart monitor) during school break.
RESULTS


Sleep duration contributed to the variance in BMR (β = 0.11, P = .009) after adjusting for age-group, sex, lean and fat mass, but not to the variance in TEE. Late sleep timing was related to lower PA. In the younger age-group, children who met recommended sleep duration on ≥50% of the 7 days had higher light PA (P = .03) and lower sedentary time (P = .009).
CONCLUSION


Suboptimal sleep is associated with lower BMR, lower PA, and higher sedentary behaviours in young children. Prospective studies are needed to confirm if insufficient sleep duration or late sleep timing contribute to obesity risk by increasing sedentary behaviours and decreasing BMR.",2020,"RESULTS


Sleep duration contributed to the variance in BMR (β = 0.11, P = .009) after adjusting for age-group, sex, lean and fat mass, but not to the variance in TEE.","['children', 'Fifty nine children in two age-groups (5-11 and 12-18\u2009years) underwent', 'young children']","['evaluation of body composition (DXA), BMR in a room calorimeter, free-living TEE by doubly labelled water method, sleep and PA (7-day Actiheart monitor) during school break']","['sedentary time', 'Late sleep timing', 'sleep duration and quality to energy expenditure and physical activity', 'sleep duration', 'higher light PA', 'basal metabolic rate (BMR), total energy expenditure (TEE) and physical activity (PA', 'sedentary behaviours']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",59.0,0.0259032,"RESULTS


Sleep duration contributed to the variance in BMR (β = 0.11, P = .009) after adjusting for age-group, sex, lean and fat mass, but not to the variance in TEE.","[{'ForeName': 'Ishita', 'Initials': 'I', 'LastName': 'Jindal', 'Affiliation': ""Energy Metabolism Unit, USDA/ARS Children's Nutrition Research Center, Houston, TX.""}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Puyau', 'Affiliation': ""Energy Metabolism Unit, USDA/ARS Children's Nutrition Research Center, Houston, TX.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Adolph', 'Affiliation': ""Energy Metabolism Unit, USDA/ARS Children's Nutrition Research Center, Houston, TX.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Butte', 'Affiliation': ""Energy Metabolism Unit, USDA/ARS Children's Nutrition Research Center, Houston, TX.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Musaad', 'Affiliation': ""Energy Metabolism Unit, USDA/ARS Children's Nutrition Research Center, Houston, TX.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Energy Metabolism Unit, USDA/ARS Children's Nutrition Research Center, Houston, TX.""}]",Pediatric obesity,['10.1111/ijpo.12751']
1921,33191772,Effects of n-3 Fatty Acid Supplements in Elderly Patients after Myocardial Infarction: A Randomized Controlled Trial.,"Background:  High intake of marine n-3 polyunsaturated fatty acids (PUFA) has been associated with reduced risk of cardiovascular events; however, this has not been confirmed in patients with a recent acute myocardial infarction (AMI). Elderly patients are at particularly increased cardiovascular risk after MI, but few trials address this group specifically. Omega-3 fatty acids hold the potential to reduce cardiovascular events with limited adverse effects in this vulnerable group. The hypothesis was that daily addition of 1.8g n-3 PUFA to standard of care secondary prophylaxis in elderly patients who have survived an AMI would reduce the risk of subsequent cardiovascular events during 2 years follow-up.  Methods:  The OMega-3 fatty acids in Elderly with Myocardial Infarction (OMEMI) trial is an investigator-initiated, multi-center, randomized clinical trial adding 1.8 g n-3 PUFA (930 mg EPA and 660 mg DHA) versus placebo (corn oil) daily to standard of care in 70-82 years old patients with recent (2-8 weeks) AMI. The primary endpoint was a composite of non-fatal AMI, unscheduled revascularization, stroke, all-cause death, heart failure hospitalization after two years. The secondary outcome was new atrial fibrillation. The safety outcome was major bleeding. Serum fatty acids were measured as biomarkers of adherence.  Results:  In total, 1,027 patients were randomized. Follow-up data were available for 1,014 patients who were included in the intention-to-treat analysis. Mean ± SD age was 75±3.6 years, 294 (29%) were female and mean triglycerides were 111.4±61.9 mg/dL. The primary endpoint occurred in 108 (21.4%) patients on n-3 PUFA vs 102 (20.0%) on placebo (HR 1.08 [95%CI 0.82-1.41], p=0.60). The secondary endpoint occurred in 28 (7.2%) patients on n-3 PUFA vs 15 (4.0%) on placebo (1.84 [0.98 -3.45], p=0.06). Median changes in EPA and DHA were +87% and +16% for n-3 PUFA vs -13% and -8% for placebo. Major bleeding occurred in 54 (10.7%) and 56 (11.0%) in the n-3 PUFA and placebo groups, respectively (p=0.87). Similar results were found in per-protocol analysis (n=893).  Conclusions:  We could not detect reduction in clinical events in our elderly patients with a recent AMI, treated with 1.8 g n-3 PUFAs daily for 2 years.  Clinical Trial Registration:  OMEMI Study; URL: https://clinicaltrials.gov Unique Identifier: NCT01841944.",2020,Median changes in EPA and DHA were +87% and +16% for n-3 PUFA vs -13% and -8% for placebo.,"['elderly patients with a recent AMI, treated with 1.8 g n-3 PUFAs daily for 2 years', '1,027 patients were randomized', 'Elderly Patients after Myocardial Infarction', 'in 70-82 years old patients with recent (2-8 weeks', '1,014 patients who were included in the intention-to-treat analysis', 'Mean ± SD age was 75±3.6 years, 294 (29%) were female and mean triglycerides were 111.4±61.9 mg/dL', 'elderly patients who have survived an AMI', 'patients with a recent acute myocardial infarction (AMI', 'Elderly patients', 'Elderly with Myocardial Infarction (OMEMI']","['n-3 Fatty Acid Supplements', 'placebo (corn oil) daily to standard of care', 'OMega-3 fatty acids', 'URL', 'placebo', 'n-3 PUFA', 'Omega-3 fatty acids', 'marine n-3 polyunsaturated fatty acids (PUFA']","['Median changes in EPA and DHA', 'n-3 PUFA', 'new atrial fibrillation', 'Serum fatty acids', 'Major bleeding', 'composite of non-fatal AMI, unscheduled revascularization, stroke, all-cause death, heart failure hospitalization', 'cardiovascular risk', 'risk of subsequent cardiovascular events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1027.0,0.42532,Median changes in EPA and DHA were +87% and +16% for n-3 PUFA vs -13% and -8% for placebo.,"[{'ForeName': 'Are Annesønn', 'Initials': 'AA', 'LastName': 'Kalstad', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Peder Langeland', 'Initials': 'PL', 'LastName': 'Myhre', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Laake', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Sjur Hansen', 'Initials': 'SH', 'LastName': 'Tveit', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Erik Berg', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Pal', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway; Department of Cardiology, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dennis Winston Trygve', 'Initials': 'DWT', 'LastName': 'Nilsen', 'Affiliation': 'Department of Cardiology, Stavanger University Hospital, Stavanger, Norway; Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Arnljot', 'Initials': 'A', 'LastName': 'Tveit', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway; Department of Medical Research, Vestre Viken Hospital Trust, Bærum Hospital, Gjettum, Norway.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Ingebjørg', 'Initials': 'I', 'LastName': 'Seljeflot', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Arnesen', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.052209']
1922,33191846,Cardiotoxicity and Cardiovascular Biomarkers in Patients With Breast Cancer: Data From the GeparOcto-GBG 84 Trial.,"Background Patients with breast cancer can be affected by cardiotoxic reactions through cancer therapies. Cardiac biomarkers, like NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity cardiac troponin T, might have predictive value. Methods and Results Echocardiography, ECG, hemodynamic parameters, NT-proBNP and high-sensitivity cardiac troponin T were assessed in 853 patients with early-stage breast cancer randomized in the German Breast Group GeparOcto-GBG 84 phase III trial. Patients received neo-adjuvant dose-dense, dose-intensified epirubicin, paclitaxel, and cyclophosphamide (iddEPC group, n=424) or paclitaxel, non-pegylated doxorubicin, and in triple negative breast cancer, (paclitaxel, non-pegylated doxorubicin, carboplatin group, n=429) treatment for 18 weeks. Patients positive for human epidermal growth receptor 2 (n=354, 41.5%) received monoclonal antibodies on top of allocated therapy; 119 (12.9%) of all patients showed a cardiotoxic reaction during therapy (15 [1.8%] using a more strict definition). Presence of cardiotoxic reactions was irrespective of treatment allocation ( P =0.31). Small but significant increases in NT-proBNP developed early in patients with a cardiotoxic reaction as compared with those without in whom NT-proBNP rose only towards the end of therapy ( P =0.04). High-sensitivity cardiac troponin T rose early in both groups. Logistic regression showed that NT-proBNP (odds ratio [OR], 1.03; 95% CI, 1.008-1.055;  P =0.01) and hemoglobin (OR, 1.31; 95% CI, 1.05-1.63;  P =0.02) measured at 6 weeks after treatment initiation were significantly associated with cardiotoxic reactions. Conclusions NT-proBNP and hemoglobin are significantly associated with cardiotoxic reactions in patients with early-stage breast cancer undergoing dose-dense and dose-intensified chemotherapy, but high-sensitivity cardiac troponin T is not. Registration URL: http://www.clinicaltrials.gov; Unique identifier: NCT02125344.",2020,Small but significant increases in NT-proBNP developed early in patients with a cardiotoxic reaction as compared with those without in whom NT-proBNP rose only towards the end of therapy ( P =0.04).,"['patients with early-stage breast cancer', ' Patients with breast cancer', 'Patients With Breast Cancer', '853 patients with early-stage breast cancer randomized in the German Breast Group GeparOcto-GBG 84 phase III trial']","['neo-adjuvant dose-dense, dose-intensified epirubicin, paclitaxel, and cyclophosphamide (iddEPC group, n=424) or paclitaxel, non-pegylated doxorubicin, and in triple negative breast cancer, (paclitaxel, non-pegylated doxorubicin, carboplatin']","['Echocardiography, ECG, hemodynamic parameters, NT-proBNP and high-sensitivity cardiac troponin T', 'cardiotoxic reaction', 'monoclonal antibodies', 'NT-proBNP', 'cardiotoxic reactions', 'hemoglobin ', 'Cardiotoxicity and Cardiovascular Biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",853.0,0.136134,Small but significant increases in NT-proBNP developed early in patients with a cardiotoxic reaction as compared with those without in whom NT-proBNP rose only towards the end of therapy ( P =0.04).,"[{'ForeName': 'Alexandra Maria', 'Initials': 'AM', 'LastName': 'Rüger', 'Affiliation': 'Department of Cardiology Charité - Universitätsmedizin BerlinBerlin, Campus Virchow-Klinikum Berlin Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases University Hospital and German Cancer Research Center Heidelberg Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast GroupNeu-Isenburg and Center for Hematology and Oncology Bethanien Frankfurt Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Praxis Bethanien Frankfurt Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital Schleswig-Holstein Kiel Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Department of Gynecologic Oncology Medical Faculty Mannheim Heidelberg UniversityUniversity Hospital Mannheim Mannheim Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lübbe', 'Affiliation': 'Diakovere Henriettenstift Hannover Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Sinn', 'Affiliation': 'Charité Universitätsmedizin Berlin Berlin Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University Hospital Frankfurt Frankfurt Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital RWTH Aachen Aachen Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology University Medical Center Hamburg Eppendorf Hamburg Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum Hamburg Hamburg Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital Marburg Marburg Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen Nuremberg Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast GroupNeu-Isenburg and Center for Hematology and Oncology Bethanien Frankfurt Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Garfias-Macedo', 'Affiliation': 'Department of Cardiology and Pneumology University of Göttingen Medical Center Göttingen Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Hasenfuß', 'Affiliation': 'Department of Cardiology and Pneumology University of Göttingen Medical Center Göttingen Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Cardiology Charité - Universitätsmedizin BerlinBerlin, Campus Virchow-Klinikum Berlin Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast GroupNeu-Isenburg and Center for Hematology and Oncology Bethanien Frankfurt Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology University of Göttingen Medical Center Göttingen Germany.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.018143']
1923,33191871,Resilient youth with neurofibromatosis: Less perceived stress and greater life satisfaction after an 8-week virtual mind-body intervention.,"OBJECTIVES


The neurofibromatoses (NF) are rare, incurable genetic disorders. Adolescents with NF report greater stress and lower life satisfaction compared to same-age peers. We report on changes in life satisfaction and perceived stress following an 8-week single-blind, virtual randomized controlled trial of a mind-body intervention versus an educational control.
METHODS


Adolescents ( N  = 51) completed measures at baseline, post-treatment ( N  = 45), and 6 months later ( N  = 39).
RESULTS


Adolescents were geographically diverse, 41% female, and 76% White. Adolescents randomized to the intervention had greater improvements from baseline to post-test in stress compared to those in control; these were maintained through 6 months. Those randomized to intervention also reported greater improvement in life satisfaction from baseline to 6 months.
CONCLUSIONS


The NF tailored mind-body program resulted in sustained reduction in stress and improved life satisfaction. A virtual model of mind-body care may help adolescents who face other chronic medical illness.",2020,Adolescents randomized to the intervention had greater improvements from baseline to post-test in stress compared to those in control; these were maintained through 6 months.,"['Resilient youth with neurofibromatosis', 'Adolescents with NF report greater', 'Adolescents were geographically diverse, 41% female, and 76% White', 'Adolescents ( N \u2009=\u200951', 'adolescents who face other chronic medical illness']",['mind-body intervention versus an educational control'],"['life satisfaction', 'stress and lower life satisfaction', 'stress and improved life satisfaction']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.05862,Adolescents randomized to the intervention had greater improvements from baseline to post-test in stress compared to those in control; these were maintained through 6 months.,"[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Lester', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2020.1830331']
1924,31813538,Effect of red blood cell storage duration on major postoperative complications in cardiac surgery: A randomized trial.,"BACKGROUND


Although observational studies suggest an association between transfusion of older red blood cell (RBC) units and increased postoperative risk, randomized trials have not supported this. The objective of this randomized trial was to test the effect of RBC storage age on outcomes after cardiac surgery.
METHODS


From July 2007 to May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination, were randomized to transfusion of RBCs stored for ≤14 days (younger units) or for ≥20 days (older units) intraoperatively and throughout the postoperative hospitalization. According to protocol, 2448 patients were excluded because they did not receive RBC transfusions. Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11 days) and the remaining 686 to receive older units (median age, 25 days). The primary endpoint was composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model. The trial was discontinued midway owing to enrollment constraints.
RESULTS


A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The GEE average relative-effect odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083) for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation, although all CIs crossed 1.0.
CONCLUSIONS


This clinical trial, which was stopped at its midpoint owing to enrollment constraints, supports neither the efficacy nor the futility of transfusing either younger or older RBC units. The effects of transfusing RBCs after even more prolonged storage (35-42 days) remains untested.",2020,In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15],"['cardiac surgery', '3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination', '5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group', 'Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11\xa0days) and the remaining 686 to receive older units (median age, 25\xa0days', '2448 patients were excluded because they did not receive RBC transfusions']","['red blood cell storage duration', 'transfusing RBCs']","['hospital mortality', 'composite morbidity and mortality endpoint', 'composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0003956', 'cui_str': 'Ascending aorta structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",3835.0,0.228617,In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15],"[{'ForeName': 'Colleen G', 'Initials': 'CG', 'LastName': 'Koch', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, Md. Electronic address: ckoch11@jhmi.edu.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Researc, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andra E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'Department of Outcomes Researc, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Division of Science, Department of Biostatistics, MD Anderson Cancer Center, Houston, Tex.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Outcomes Researc, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Figueroa', 'Affiliation': 'Department of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Mihaljevic', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Svensson', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Eugene H', 'Initials': 'EH', 'LastName': 'Blackstone', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.165']
1925,33199226,Effect of intravenous lidocaine on ischemia-reperfusion injury in DIEP microsurgical breast reconstruction. A prospective double-blind randomized controlled clinical trial.,"BACKGROUND


Ischemia-reperfusion injury in free flaps is associated with tissue damage and is one of the main factors causing flap failure in reconstructive microsurgery. The aim of this study is to assess whether any ischemia-reperfusion injury takes place during a microsurgical flap reconstruction as seen through the levels of malondialdehyde (MDA) and superoxide dismutase, biomarkers of oxidative stress, and to analyze the effect of lidocaine in this process.
METHODS


Twenty-four patients operated for immediate breast reconstruction using the Deep Inferior Epigastric Perforator free flap technique were divided into two groups: one group was treated with a lidocaine intravenous perfusion and the other group with a saline perfusion. MDA and superoxide dismutase (SOD) levels were measured at several points before, during, and after surgery.
RESULTS


There was an increase in MDA levels in both groups, but the lidocaine group experienced a decrease during reperfusion. On the other hand, we observed a rise in SOD levels in both groups, but a decrease during reperfusion in the placebo group. However, these differences between groups were not statistically significant.
CONCLUSIONS


The decreased SOD activity and increased MDA content in our research prove a redox imbalance and high reactive oxygen species levels in flaps, indicating that tissues experience ischemia-reperfusion injury during microsurgical reconstruction. Lidocaine may have a protective effect in free flap surgery, but our results were not statistically significant, so further studies will be required.",2020,"There was an increase in MDA levels in both groups, but the lidocaine group experienced a decrease during reperfusion.","['Twenty-four patients operated for', 'DIEP microsurgical breast reconstruction']","['lidocaine intravenous perfusion and the other group with a saline perfusion', 'immediate breast reconstruction using the Deep Inferior Epigastric Perforator free flap technique', 'Lidocaine', 'lidocaine']","['SOD levels', 'malondialdehyde (MDA) and superoxide dismutase, biomarkers of oxidative stress', 'MDA levels', 'MDA and superoxide dismutase (SOD) levels', 'SOD activity and increased MDA content']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0441031', 'cui_str': 'Free flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",24.0,0.127296,"There was an increase in MDA levels in both groups, but the lidocaine group experienced a decrease during reperfusion.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Del Rio', 'Affiliation': 'Department of Plastic Surgery, University Hospital Germans Trias i Pujol, Carretera de Canyet s/n, Barcelona 08916, Spain. Electronic address: mariadelriomd@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lopez-Cabrera', 'Affiliation': 'Paloma Lopez-Cabrera, MD, Department of Plastic Surgery, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Malagón-López', 'Affiliation': 'Department of Plastic Surgery, University Hospital Germans Trias i Pujol, Carretera de Canyet s/n, Barcelona 08916, Spain.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Del Caño-Aldonza', 'Affiliation': 'Department of Anesthesiology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Castello', 'Affiliation': 'Paloma Lopez-Cabrera, MD, Department of Plastic Surgery, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Provencio', 'Affiliation': 'Department of Oncology, Autonomous University of Madrid, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.10.018']
1926,33199228,A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801).,"BACKGROUND


Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is now a standard treatment of previously untreated EGFR-mutated advanced non-small-cell lung cancer (NSCLC). However, disease progression occurs within 19 months of treatment. In the NEJ009 study, gefitinib plus carboplatin plus pemetrexed demonstrated significantly better progression-free and overall survival compared with gefitinib monotherapy. Furthermore, the Lung Oncology Group in Kyushu and North East Japan Study Group, major clinical trial groups in Japan, conducted a randomized phase II study to evaluate the efficacy and safety of second-line osimertinib plus carboplatin plus pemetrexed versus osimertinib monotherapy for patients with disease progression during first-line EGFR tyrosine kinase inhibitor therapy and the EGFR T790M resistance mutation (TAKUMI trial; trial registration no., jRCTs071180062). In the first treatment course for the initial 24 patients, no safety issues were reported in the combination arm. Thus, we have planned this phase II study to evaluate the safety and preliminary efficacy of osimertinib plus cisplatin/carboplatin plus pemetrexed therapy for patients with previously untreated EGFR-mutated NSCLC.
PATIENTS AND METHODS


A total of 66 patients will be enrolled, because this sample size will be adequate for assessing treatment safety and efficacy. The co-primary endpoints include safety and the objective response rate, and the secondary endpoints include the complete response rate, disease control rate, and progression-free survival.
CONCLUSIONS


This is the first study to explore the efficacy and safety of osimertinib combined with platinum-based chemotherapy in previously untreated NSCLC patients with EGFR-sensitizing mutations. Our findings could provide valuable information for phase III studies such as FLAURA2 and for developing treatment strategies for EGFR-mutated NSCLC.",2020,"In the first treatment course for the initial 24 patients, no safety issues were reported in the combination arm.","['66 patients', 'previously untreated NSCLC patients with EGFR-sensitizing mutations', 'previously untreated EGFR-mutated advanced non-small-cell lung cancer (NSCLC', 'Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer', 'patients with previously untreated EGFR-mutated NSCLC', 'patients with disease progression during first-line EGFR tyrosine kinase inhibitor therapy and the EGFR T790M resistance mutation']","['osimertinib combined with platinum-based chemotherapy', 'osimertinib plus cisplatin/carboplatin plus pemetrexed therapy', 'Osimertinib Combined With Platinum Plus Pemetrexed', 'second-line osimertinib plus carboplatin plus pemetrexed versus osimertinib monotherapy', 'gefitinib plus carboplatin plus pemetrexed']","['complete response rate, disease control rate, and progression-free survival', 'progression-free and overall survival', 'disease progression', 'efficacy and safety', 'safety and the objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",66.0,0.0631096,"In the first treatment course for the initial 24 patients, no safety issues were reported in the combination arm.","[{'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Asahina', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Division of Pulmonary Medicine, Allergy and Rheumatology, Department of Internal Medicine, Iwate Medical University School of Medicine, Iwate, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seike', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Oizumi', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kagamu', 'Affiliation': 'Division of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Isobe', 'Affiliation': 'Division of Medical Oncology and Respiratory Medicine, Department of Internal Medicine, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan. Electronic address: kobakuni@saitamamed.ac.jp.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.09.023']
1927,33199274,Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial.,"OBJECTIVES


To study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).
METHODS


In this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.
RESULTS


Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.
CONCLUSIONS


Fasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit-risk.",2020,"RESULTS


Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39).","['patients with CLBP with and without pOA', 'patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids', 'patients with chronic low back pain', 'moderate-to-severe, chronic low back pain (CLBP']","['placebo', 'fasinumab']","['efficacy', 'CLBP pain and function', 'average daily low back pain intensity (LBPI) numeric rating score', 'RMDQ and PGA improvements', 'efficacy and safety', 'Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA', 'LBPI reductions', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1135862', 'cui_str': 'Genus Poa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708484', 'cui_str': 'Inadequate pain relief'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4519593', 'cui_str': 'fasinumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.198965,"RESULTS


Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Dakin', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Department of Rheumatology, Altoona Center for Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, Arizona, USA.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Skrepnik', 'Affiliation': 'Research Center, Tucson Orthopedic Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'DiMartino', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Chetachi A', 'Initials': 'CA', 'LastName': 'Emeremni', 'Affiliation': 'R&D, Regeneron Pharmaceuticals Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'R&D, Regeneron Pharmaceuticals Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Geba', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA gregory.geba@regeneron.com.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217259']
1928,33199312,GP decisions to participate in emergencies: a randomised vignette study.,"Background Little is known about how General Practitioners (GPs) decide whether to participate in emergencies. Aim To test whether GPs participation is associated with cause of symptoms, distance to the patient, other patients waiting and out of hours (OOH) clinic characteristics. Design and Setting Online survey to all Norwegian GPs (n = 4701). Method GPs were randomised to vignettes describing a patient with acute shortness of breath and asked if they would participate in a call-out. The vignettes varied with respect to cause of symptoms (trauma versus illness), distance to the patient (15 versus 45 minutes) and other patients waiting at the OOH clinic (crowding versus no crowding). The survey included questions about OOH clinic characteristics. Results Of the 1013 GPs (22%) that responded, 76% reported that they would participate. The proportion was higher in trauma (83% versus 69%, chi square 24.8, p < 0.001), short distances (80% versus 71%, chi square 9.5, p = 0.002) and no crowding (81% versus 70% chi square 14.6, p < 0.001). Participation was associated with availability of a manned response vehicle (adjusted odds ratio [OR] 2.06, 95% confidence interval [CI] 1.25-3.41), and team training at the OOH clinic once a year (OR 1.78, 95% CI 1.12-2.82) or more than once a year (OR 3.78, 95% CI 1.64-8.68). Conclusion GPs were less likely to participate when the incident was not due to trauma, was far away and when other patients were waiting. A manned response vehicle and regular team training were associated with increased participation.",2020,"The proportion was higher in trauma (83% versus 69%, chi square 24.8, p < 0.001), short distances (80% versus 71%, chi square 9.5, p = 0.002) and no crowding (81% versus 70% chi square 14.6, p < 0.001).",[],[],['short distances'],[],[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.136465,"The proportion was higher in trauma (83% versus 69%, chi square 24.8, p < 0.001), short distances (80% versus 71%, chi square 9.5, p = 0.002) and no crowding (81% versus 70% chi square 14.6, p < 0.001).","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Hjortdahl', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway Faculty of Health Sciences, Tromso, Norway magnus.hjortdahl@gmail.com.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Gyrd-Hansen', 'Affiliation': 'Syddansk Universitet, Odense, Denmark.'}, {'ForeName': 'Peder A', 'Initials': 'PA', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway Faculty of Health Sciences, Tromso, Norway.'}]",BJGP open,['10.3399/bjgpopen20X101153']
1929,33199379,"Addition of dexamethasone to local infiltration analgesia in elective total knee arthroplasty: double-blind, randomized control trial.","BACKGROUND AND OBJECTIVES


Total knee arthroplasty is associated with significant pain, and effective analgesia is beneficial to patient satisfaction and functional outcomes. Studies have demonstrated that dexamethasone may have a facilitatory role on the action of local anesthesia, but this effect, when added to a local infiltration analgesia (LIA) mixture for patients having knee arthroplasty, is underexplored. Our hypothesis was that the addition of dexamethasone to local anesthetic infiltration would improve analgesic outcomes following total knee arthroplasty.
METHODS


We performed a double-blind, randomized controlled trial of 140 patients undergoing elective, unilateral, total knee arthroplasty. Patients were randomly allocated to receive either 2 mL of saline 0.9% or 2 mL of dexamethasone 4 mg/mL added to a LIA mixture. Our primary outcome was 24 hours of oral morphine equivalent consumption. Our secondary outcomes included short-term and long-term analgesic and functional outcomes and adverse events.
RESULTS


A total of 72 patients were included in the saline group and 68 were included in the dexamethasone group. We found comparable 24 hours of morphine consumption between saline and dexamethasone groups, with a median of 60 (IQR 40-105 (range 16-230)) mg and 56 (IQR 41-75 (range 0-300)) mg, respectively (p=0.096). Dexamethasone was associated with a statistically significant reduction in total inpatient opioid consumption, incidence of requiring rescue patient-controlled analgesia, length of hospital stay, and postoperative nausea, compared with saline. Patients in the dexamethasone group had a greater range of joint movement and distance walked on postoperative day 1 than the saline group. There were no differences in rest or active pain scores, timed up and go or 3-month outcomes.
CONCLUSIONS


Dexamethasone 8 mg was associated with no improvements in 24 hours of morphine consumption but was associated with modest improvements in short-term analgesia, short-term function, length of stay and postoperative nausea. There were no long-term benefits in the use of dexamethasone in LIA for patients undergoing total knee arthroplasty.
TRIAL REGISTRATION NUMBER


NCT02760043.",2020,Patients in the dexamethasone group had a greater range of joint movement and distance walked on postoperative day 1 than the saline group.,"['140 patients undergoing elective, unilateral, total knee arthroplasty', 'total knee arthroplasty', 'patients having knee arthroplasty', 'patients undergoing total knee arthroplasty', 'A total of 72 patients were included in the saline group and 68 were included in the dexamethasone group', 'elective total knee arthroplasty']","['dexamethasone', 'Dexamethasone', '2 mL of saline 0.9% or 2 mL of dexamethasone 4 mg/mL added to a LIA mixture']","['analgesic outcomes', 'total inpatient opioid consumption, incidence of requiring rescue patient-controlled analgesia, length of hospital stay, and postoperative nausea', 'rest or active pain scores, timed up and go or 3-month outcomes', 'short-term and long-term analgesic and functional outcomes and adverse events', 'range of joint movement and distance walked', 'short-term analgesia, short-term function, length of stay and postoperative nausea']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0985346', 'cui_str': 'Dexamethasone 4 MG'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",140.0,0.690024,Patients in the dexamethasone group had a greater range of joint movement and distance walked on postoperative day 1 than the saline group.,"[{'ForeName': 'Kariem', 'Initials': 'K', 'LastName': 'El-Boghdadly', 'Affiliation': ""Department of Theatres, Anaesthesia and Perioperative Medicine, Guy's and St Thomas' NHS Foundation Trust, London, UK elboghdadly@gmail.com.""}, {'ForeName': 'Anthony James', 'Initials': 'AJ', 'LastName': 'Short', 'Affiliation': 'Department of Anaesthetics, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Gandhi', 'Affiliation': 'Division of Orthopedic Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Department of Anesthesia and Pain Medicine, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-102079']
1930,33199417,Impact of patient characteristics on efficacy and safety of once-weekly semaglutide versus dulaglutide: SUSTAIN 7  post hoc  analyses.,"OBJECTIVE


In SUSTAIN 7, once-weekly semaglutide demonstrated superior glycated haemoglobin (HbA 1c ) and body weight (BW) reductions versus once-weekly dulaglutide in subjects with type 2 diabetes (T2D). This  post hoc  analysis investigated the impact of clinically relevant subject characteristics on treatment effects of semaglutide versus dulaglutide.
DESIGN


Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5-10, >10 years), HbA 1c  (≤7.5, >7.5-8.5, >8.5% (≤58, >58-69, >69 mmol/mol)) and body mass index (BMI) (<30, 30-<35, ≥35 kg/m 2 ).
SETTING


194 sites; 16 countries.
PARTICIPANTS


Subjects with T2D (n=1199) exposed to treatment.
INTERVENTIONS


Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly.
PRIMARY AND SECONDARY OUTCOME MEASURES


Change in HbA 1c  (primary endpoint) and BW (confirmatory secondary endpoint) from baseline to week 40; proportion of subjects achieving HbA 1c  targets (<7%, ≤6.5% (<53, ≤48 mmol/mol)) and weight-loss responses (≥5%, ≥10%) at week 40; and safety.
RESULTS


HbA 1c  and BW reductions (estimated treatment difference ranges: -0.22 to -0.70%-point; -1.76 to -3.84 kg) and proportion of subjects achieving HbA 1c  targets and weight-loss responses were statistically significantly greater for the majority of comparisons of semaglutide versus dulaglutide within each subgroup category and, excepting glycaemic control within the low-dose comparison in HbA 1c  subgroups, this was irrespective of subgroup or dose comparison. Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.
CONCLUSIONS


Consistently greater improvements in HbA 1c  and BW with semaglutide versus dulaglutide, regardless of age, sex, diabetes duration, glycaemic control and BMI, support the efficacy of semaglutide across the continuum of care in a heterogeneous population with T2D.
TRIAL REGISTRATION NUMBER


NCT02648204.",2020,"Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.
","['194 sites; 16 countries.\nPARTICIPANTS\n\n\nSubjects with T2D', 'subjects with type 2 diabetes (T2D', 'Analyses by baseline age (<65, ≥65 years), sex (male, female), diabetes duration (≤5, >5-10, >10 years), HbA 1c  (≤7.5, >7.5-8.5, >8.5% (≤58, >58-69, >69 mmol/mol)) and body mass index (BMI) (<30, 30-<35, ≥35 kg/m 2 ']","['once-weekly semaglutide versus dulaglutide', 'Semaglutide 0.5 mg versus dulaglutide 0.75 mg (low-dose comparison); semaglutide 1.0 mg versus dulaglutide 1.5 mg (high-dose comparison), all subcutaneously once weekly']","['Gastrointestinal adverse events', 'weight-loss responses', 'efficacy and safety', 'superior glycated haemoglobin (HbA 1c ) and body weight (BW) reductions', 'Change in HbA 1c  (primary endpoint) and BW', 'HbA 1c  and BW reductions', 'proportion of subjects achieving HbA 1c  targets and weight-loss responses']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.0328079,"Gastrointestinal adverse events, the most common with both treatments, were reported by more women than men and, with semaglutide, decreased with increasing BMI.
","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'Translational Research Institute, AdventHealth, Orlando, Florida, USA Richard.Pratley.MD@AdventHealth.com.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Division of Endocrinology, Diabetes & Hypertension, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Andrei-Mircea', 'Initials': 'AM', 'LastName': 'Catarig', 'Affiliation': 'Medical and Science, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Lüdemann', 'Affiliation': 'Diabetes-Falkensee, Diabetes Centre and Centre for Clinical Studies, Falkensee, Germany.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Yildirim', 'Affiliation': 'Global Medical Affairs, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Adie', 'Initials': 'A', 'LastName': 'Viljoen', 'Affiliation': 'Borthwick Diabetes Research Centre, Lister Hospital, Stevenage, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037883']
1931,33199418,Randomised controlled trial to assess the effectiveness of apnoeic oxygenation in adults using low-flow or high-flow nasal cannula with head side elevation versus usual care to prevent desaturation during endotracheal intubation in the emergency department (ApOxED): study protocol.,"INTRODUCTION


Apnoeic oxygenation is a process of delivering continuous oxygen through nasal cannula during direct laryngoscopy. The oxygen that is delivered through these nasal cannulas is either low flow or high flow. Although the effectiveness of apnoeic oxygenation has been shown through systematic reviews and randomised controlled trials, a comparison of high-flow versus low-flow oxygen delivery has not been tested through a superiority study design. In this study we propose to assess the effectiveness of giving low-flow oxygen with head side elevation versus high-flow oxygen with head side elevation against the usual practice of care in which no oxygen is provided during direct laryngoscopy.
METHODS AND ANALYSIS


This will be a three-arm study instituting a block randomisation technique with a sample size of 46 in each arm (see table 1). Due to the nature of the intervention, no blinding will be introduced. The primary outcomes will be lowest non-invasive oxygen saturation measurement during direct laryngoscopy and during the 2 min after the placement of the tube and the first pass success rate. The intervention constitutes head side elevation up to 30° for improving glottis visualisation together with low-flow or high-flow oxygen delivery through nasal cannula to increase safe apnoea time for participants undergoing endotracheal intubation. Primary analysis will be intention to treat.
ETHICS AND DISSEMINATION


The study is approved by the Ethical Review Committee of Aga Khan University Hospital (2019-0726-2463). The project is an institution University Research Committee grant recipient 192 002ER-PK. The results of the study will be disseminated among participants, patient communities and healthcare professionals in the institution through seminars, presentations and emails. Further, the findings will be published in a highly accessed peer-reviewed medical journal and will be presented at both national and international conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04242537).",2020,"The results of the study will be disseminated among participants, patient communities and healthcare professionals in the institution through seminars, presentations and emails.","['adults using', 'participants undergoing endotracheal intubation', 'Aga Khan University Hospital (2019-0726-2463']","['apnoeic oxygenation', 'intervention constitutes head side elevation up to 30° for improving glottis visualisation together with low-flow or high-flow oxygen delivery through nasal cannula', 'low-flow or high-flow nasal cannula with head side elevation versus usual care to prevent desaturation during endotracheal intubation', 'giving low-flow oxygen with head side elevation versus high-flow oxygen with head side elevation']",['lowest non-invasive oxygen saturation measurement during direct laryngoscopy and during the 2\u2009min after the placement of the tube and the first pass success rate'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0475745', 'cui_str': 'Apneic oxygenation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0229998', 'cui_str': 'Structure of side of head'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0444693', 'cui_str': 'First pass'}]",,0.194581,"The results of the study will be disseminated among participants, patient communities and healthcare professionals in the institution through seminars, presentations and emails.","[{'ForeName': 'Shahan', 'Initials': 'S', 'LastName': 'Waheed', 'Affiliation': 'Emergency Medicine, Aga Khan University Hospital, Karachi, Sindh, Pakistan docshahan83@hotmail.com.'}, {'ForeName': 'Nazir Najeeb', 'Initials': 'NN', 'LastName': 'Kapadia', 'Affiliation': 'Emergency Medicine, Aga Khan University Hospital, Karachi, Sindh, Pakistan.'}, {'ForeName': 'Muhammad Faisal', 'Initials': 'MF', 'LastName': 'Khan', 'Affiliation': 'Department of Anaesthesiology, Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Salima Mansoor', 'Initials': 'SM', 'LastName': 'Kerai', 'Affiliation': 'Emergency Medicine, Aga Khan University Hospital, Karachi, Sindh, Pakistan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Raheem', 'Affiliation': 'Emergency Medicine, Aga Khan University Hospital, Karachi, Sindh, Pakistan.'}, {'ForeName': 'Rubaba', 'Initials': 'R', 'LastName': 'Naeem', 'Affiliation': 'Emergency Medicine, Aga Khan University Hospital, Karachi, Sindh, Pakistan.'}]",BMJ open,['10.1136/bmjopen-2020-037964']
1932,33199419,Randomised sham-controlled double-blind trial evaluating remote ischaemic preconditioning in solid organ transplantation: a study protocol for the RIPTRANS trial.,"INTRODUCTION


Remote ischaemic preconditioning (RIPC) using a non-invasive pneumatic tourniquet is a potential method for reducing ischaemia-reperfusion injury. RIPC has been extensively studied in animal models and cardiac surgery, but scarcely in solid organ transplantation. RIPC could be an inexpensive and simple method to improve function of transplanted organs. Accordingly, we aim to study whether RIPC performed in brain-dead organ donors improves function and longevity of transplanted organs.
METHODS AND ANALYSES


RIPTRANS is a multicentre, sham-controlled, parallel group, randomised superiority trial comparing RIPC intervention versus sham-intervention in brain-dead organ donors scheduled to donate at least one kidney. Recipients of the organs (kidney, liver, pancreas, heart, lungs) from a randomised donor will be included provided that they give written informed consent. The RIPC intervention is performed by inflating a thigh tourniquet to 300 mm Hg 4 times for 5 min. The intervention is done two times: first right after the declaration of brain death and second immediately before transferring the donor to the operating theatre. The sham group receives the tourniquet, but it is not inflated. The primary endpoint is delayed graft function (DGF) in kidney allografts. Secondary endpoints include short-term functional outcomes of transplanted organs, rejections and graft survival in various time points up to 20 years. We aim to show that RIPC reduces the incidence of DGF from 25% to 15%. According to this, the sample size is set to 500 kidney transplant recipients.
ETHICS AND DISSEMINATION


This study has been approved by Helsinki University Hospital Ethics Committee and Helsinki University Hospital's Institutional Review Board. The study protocol was be presented at the European Society of Organ Transplantation congress in Copenhagen 14-15 September 2019. The study results will be submitted to an international peer-reviewed scientific journal for publication.
TRIAL REGISTRATION NUMBER


NCT03855722.",2020,"Secondary endpoints include short-term functional outcomes of transplanted organs, rejections and graft survival in various time points up to 20 years.","['solid organ transplantation', 'brain-dead organ donors scheduled to donate at least one kidney', '500 kidney transplant recipients', 'European Society of Organ Transplantation congress in Copenhagen 14-15 September 2019', 'Recipients of the organs (kidney, liver, pancreas, heart, lungs']","['RIPC intervention versus sham-intervention', 'Remote ischaemic preconditioning (RIPC', 'remote ischaemic preconditioning', 'RIPC']","['short-term functional outcomes of transplanted organs, rejections and graft survival', 'delayed graft function (DGF) in kidney allografts', 'function and longevity of transplanted organs']","[{'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0006110', 'cui_str': 'Brain death'}, {'cui': 'C0029206', 'cui_str': 'Organ donor'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0282415', 'cui_str': 'Congresses'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332835', 'cui_str': 'Transplant'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}]",,0.294252,"Secondary endpoints include short-term functional outcomes of transplanted organs, rejections and graft survival in various time points up to 20 years.","[{'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Uutela', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Helanterä', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lemström', 'Affiliation': 'Department of Cardiothoracic Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Passov', 'Affiliation': 'Department of Perioperative, Intensive Care and Pain Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Syrjälä', 'Affiliation': 'Department of Cardiothoracic Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Åberg', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Nordin', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Lempinen', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Transplantation and Liver Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland ville.sallinen@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038340']
1933,33199421,"Laparoscopic bowel resection combined with infliximab treatment (LaRIC) versus infliximab for terminal ileitis in Crohn's disease: a randomised, controlled, open-label trial.","INTRODUCTION


Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract with an increasing incidence and prevalence worldwide. The early use of anti--tumour necrosis factor agents, such as infliximab, in patients with an aggressive form of Crohn's disease has become part of routine practice. However, infliximab has limitations, and early surgery might benefit patients more. The objective of this study was to compare laparoscopic bowel resection with infliximab treatment in patients with moderately or severely active Crohn's disease with respect to endoscopic remission. The laparoscopic bowel resection combined with infliximab treatment trial is the first randomised controlled trial to demonstrate if early surgery can improve the outcome of patients with Crohn's disease with limited non-stricturing disease treated with infliximab.
METHODS AND ANALYSIS


This is a randomised, open-label, controlled trial at Renji Hospital. In this study, a total of 106 adult patients aged 18-80 years with moderately or severely active and steroid-dependent or steroid-resistant Crohn's disease of the distal ileum will be randomly assigned in a 1:1 ratio to the control and surgery groups. The primary outcome is 12-month endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease in the control group and the Rutgeerts score in the surgery group. The secondary outcomes are clinical remission, surgery rate, quality of life, Crohn's disease-related medical costs and Crohn's disease-related morbidity. The patients will be followed up every 6 months after randomisation through intestinal magnetic resonance enterography and colonoscopy for either 3 years or until clinical remission.
ETHICS AND DISSEMINATION


All participants will provide informed consent. The protocol has been approved by the Medical Ethical Committee of the Academic Medical Center in Shanghai (No KY2019-180). Results will be disseminated through peer-reviewed journals and scientific conference presentations.
TRIAL REGISTRATION NUMBER


ChiCTR2000029323.",2020,The primary outcome is 12-month endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease in the control group and the Rutgeerts score in the surgery group.,"[""106 adult patients aged 18-80 years with moderately or severely active and steroid-dependent or steroid-resistant Crohn's disease of the distal ileum"", ""patients with an aggressive form of Crohn's disease"", ""patients with moderately or severely active Crohn's disease with respect to endoscopic remission"", ""Crohn's disease"", ""patients with Crohn's disease with limited non-stricturing disease treated with infliximab""]","['Laparoscopic bowel resection combined with infliximab treatment (LaRIC) versus infliximab', 'infliximab', 'laparoscopic bowel resection combined with infliximab', 'intestinal magnetic resonance enterography and colonoscopy']","[""Simple Endoscopic Score for Crohn's Disease"", 'laparoscopic bowel resection', ""clinical remission, surgery rate, quality of life, Crohn's disease-related medical costs and Crohn's disease-related morbidity"", '12-month endoscopic remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C4274338', 'cui_str': 'Magnetic resonance enterography'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",106.0,0.206334,The primary outcome is 12-month endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease in the control group and the Rutgeerts score in the surgery group.,"[{'ForeName': 'Xiuxiu', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China.'}, {'ForeName': 'Tienan', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Jing', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China.'}, {'ForeName': 'Sailiang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Inflammatory Bowel Disease Research Center, Shanghai Institute of Digestive Disease, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China fishmeangood@163.com zhongming011271@renji.com qiaoyuqi@renji.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China fishmeangood@163.com zhongming011271@renji.com qiaoyuqi@renji.com.'}, {'ForeName': 'Minhao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Gastrointestinal Surgery, Shanghai Jiao Tong University School of Medicine Affiliated to Renji Hospital, Shanghai, China fishmeangood@163.com zhongming011271@renji.com qiaoyuqi@renji.com.'}]",BMJ open,['10.1136/bmjopen-2020-038429']
1934,33199422,"A study protocol for a phase II randomised, double-blind, placebo-controlled trial of sodium selenate as a disease-modifying treatment for behavioural variant frontotemporal dementia.","INTRODUCTION


Behavioural variant frontotemporal dementia (bvFTD) is a neurodegenerative disorder often neuropathologically associated with the accumulation of abnormally hyperphosphorylated tau, for which there is currently no disease-modifying treatment. Previous work by our group has shown sodium selenate upregulates the activity of protein phosphatase 2 in the brain, increasing the rate of tau dephosphorylation. The objective of this study is to evaluate the efficacy and safety of sodium selenate as a disease-modifying treatment for bvFTD.
METHODS AND ANALYSIS


This will be a multisite, phase IIb, double-blind placebo-controlled trial of sodium selenate. One hundred and twenty participants will be enrolled across 4 Australian academic hospitals. Following screening eligible participants will be randomised (1:1) to sodium selenate (15 mg three times a day) or placebo for 52 weeks. Participants will have regular safety and efficacy visits throughout the study period. The primary study outcome will be percentage brain volume change (PBVC) as measured on MRI over 52 weeks of treatment. This will be analysed with a general linear model (analysis of covariance (ANCOVA)) with the PBVC as an output, the treatment as an input and the baseline brain volume as covariate for adjustment purposes. Secondary outcomes include safety and tolerability measures, and efficacy measures; change in cerebrospinal fluid total-tau, Addenbrooke's Cognitive Examination-III and Cambridge Behavioural Inventory-Revised scores over the 52 weeks of treatment. These will also be analysed with ANCOVA where the corresponding baseline measure will be incorporated in the model. Additional exploratory outcomes will include other imaging, cognitive and biospecimen analyses.
ETHICS AND DISSEMINATION


The study was approved by the Human Research and Ethics Committee of the lead site as part of the Australian Multisite Ethics approval system. The results of the study will be presented at national and international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ACTRN12620000236998 .",2020,The primary study outcome will be percentage brain volume change (PBVC) as measured on MRI over 52 weeks of treatment.,"['One hundred and twenty participants will be enrolled across 4 Australian academic hospitals', 'behavioural variant frontotemporal dementia']","['sodium selenate', 'placebo']","['efficacy and safety', ""safety and tolerability measures, and efficacy measures; change in cerebrospinal fluid total-tau, Addenbrooke's Cognitive Examination-III and Cambridge Behavioural Inventory-Revised scores"", 'regular safety and efficacy visits', 'percentage brain volume change (PBVC']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0236642', 'cui_str': ""Pick's disease""}]","[{'cui': 'C0074765', 'cui_str': 'sodium selenate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",120.0,0.33845,The primary study outcome will be percentage brain volume change (PBVC) as measured on MRI over 52 weeks of treatment.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Vivash', 'Affiliation': 'Department of Neuroscience, Monash University, Melbourne, Victoria, Australia lucy.vivash@monash.edu.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Malpas', 'Affiliation': 'Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Departments of Medicine and Radiology, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Walterfang', 'Affiliation': 'Department of Neuropsychiatry, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Brodtmann', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Piguet', 'Affiliation': 'School of Psychology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rebekah M', 'Initials': 'RM', 'LastName': 'Ahmed', 'Affiliation': 'Brain and Mind Centre, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Bush', 'Affiliation': 'Florey Institute for Neuroscience and Mental Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hovens', 'Affiliation': 'Department of Surgery, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kalincik', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Darby', 'Affiliation': 'Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Velakoulis', 'Affiliation': 'Department of Neuropsychiatry, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040100']
1935,33199423,Study protocol for a randomised controlled trial evaluating the effect of folic acid supplementation beyond the first trimester on maternal plasma unmetabolised folic acid in late gestation.,"INTRODUCTION


Taking folic acid containing supplements prior to and during early pregnancy reduces the risk of neural tube defects. Neural tube defects occur prior to 28 days postconception, after which, there is no proven benefit of continuing to take folic acid. However, many women continue to take folic acid containing supplements throughout the pregnancy. At higher intakes, folic acid is not converted to its active form and accumulates in circulation as unmetabolised folic acid (UMFA). Recently, concerns have been raised about possible links between late gestation folic acid supplementation and childhood allergy, metabolic disease and autism spectrum disorders. We aim to determine if removing folic acid from prenatal micronutrient supplements after 12 weeks gestation reduces circulating levels of maternal UMFA at 36 weeks gestation.
METHODS AND ANALYSIS


This is a parallel-design, double-blinded randomised controlled trial. Women ≥12 and <16 weeks' gestation with a singleton pregnancy and able to give informed consent are eligible to participate. Women (n=100; 50 per group) will be randomised to receive either a micronutrient supplement containing 0.8 mg of folic acid or a micronutrient supplement without folic acid daily from enrolment until delivery. The primary outcome is plasma UMFA concentration at 36 weeks gestation. Secondary outcomes include red blood cell folate and total plasma folate concentration. We will assess whether there is a difference in mean UMFA levels at 36 weeks gestation between groups using linear regression with adjustment for baseline UMFA levels and gestational age at trial entry. The treatment effect will be described as a mean difference with 95% CI.
ETHICS AND DISSEMINATION


Ethical approval has been granted from the Women's and Children's Health Network Research Ethics Committee (HREC/19/WCHN/018). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ACTRN12619001511123.",2020,Women ≥12 and <16 weeks' gestation with a singleton pregnancy and able to give informed consent are eligible to participate.,"[""Women ≥12\u2009and <16 weeks' gestation with a singleton pregnancy and able to give informed consent are eligible to participate"", 'late gestation', 'Women (n=100; 50 per group']","['micronutrient supplement containing 0.8 mg of folic acid or a micronutrient supplement without folic acid', 'folic acid', 'folic acid supplementation']","['red blood cell folate and total plasma folate concentration', 'plasma UMFA concentration', 'mean UMFA levels', 'maternal plasma unmetabolised folic acid', 'risk of neural tube defects', 'circulating levels of maternal UMFA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}]","[{'cui': 'C0427418', 'cui_str': 'Folic acid measurement, RBC'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427412', 'cui_str': 'Folic acid level - finding'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027794', 'cui_str': 'Neural tube defect'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.599069,Women ≥12 and <16 weeks' gestation with a singleton pregnancy and able to give informed consent are eligible to participate.,"[{'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Sulistyoningrum', 'Affiliation': 'SAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Green', 'Affiliation': 'SAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Telethon Kids Institute, University of Western Australia, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Faculty of Science and Engineering, Curtin University, Perth, West Australia, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Skubisz', 'Affiliation': 'SAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'SAHMRI Women and Kids Theme, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia karen.best@sahmri.com.'}]",BMJ open,['10.1136/bmjopen-2020-040416']
1936,33186125,The Role of Yoga in the Management of Bladder Pain Syndrome: A Single-Arm Pilot Study.,"Background


Bladder pain syndrome (BPS) is a devastating urologic condition characterized by irritative bladder symptoms, pelvic pain, and dyspareunia. First-line treatment includes dietary, self-care and behavioral modifications. The ancient practice of yoga is well suited to treat BPS, but evidence is lacking on its use.
Aims


To investigate the feasibility and efficacy of an integrated yoga module on BPS outcomes as measured by self-reported questionnaires from baseline to 3 months after therapy.
Methods and Materials


This was a prospective single-arm study of 8 patients who underwent 3 months of integrated yoga therapy. The treatment module was performed 3 to 4 times weekly at home with 1 session performed weekly in-office during the first month to ensure proper performance of postures. Patients completed questionnaires (Pelvic Pain and Urgency/Frequency Patient Symptom Scale [PUF], Pelvic Floor Impact Questionnaire - short form 7 [PFIQ-7], Short Form 36 questionnaire [SF-36], Pittsburgh Sleep Quality Index [PSQI]) at baseline and 3 months, including Patient Global Impression of Improvement (PGI-I) at the 3-month follow-up visit. Voiding diaries were also requested at baseline and at the 3-month assessment.
Results


There was a trend toward improvement regarding patients' responses to all questionnaires 3 months after yoga therapy, with the only statistically significant improvements noted in social function and pain components of the SF-36. There were no significant changes noted on the voiding diaries except a non-statistically significant trend toward increased voided volumes. Patients rated their experiences with yoga therapy positively.
Conclusions


Yoga therapy for BPS showed evidence of benefit for improving bothersome bladder symptoms, pain and voiding. A randomized controlled trial will follow to investigate the efficacy of this yoga module against a control group.",2020,There were no significant changes noted on the voiding diaries except a non-statistically significant trend toward increased voided volumes.,"['8 patients who underwent 3 months of', 'Bladder Pain Syndrome']","['integrated yoga therapy', 'integrated yoga module']","['feasibility and efficacy', 'bothersome bladder symptoms, pain and voiding', 'Voiding diaries', 'voiding diaries', 'questionnaires (Pelvic Pain and Urgency/Frequency Patient Symptom Scale [PUF], Pelvic Floor Impact Questionnaire - short form 7 [PFIQ-7], Short Form 36 questionnaire [SF-36], Pittsburgh Sleep Quality Index [PSQI]) at baseline and 3 months, including Patient Global Impression of Improvement (PGI-I', 'voided volumes', 'social function and pain components of the SF-36']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",8.0,0.0420992,There were no significant changes noted on the voiding diaries except a non-statistically significant trend toward increased voided volumes.,"[{'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Khandwala', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cruff', 'Affiliation': ''}]",Advances in mind-body medicine,[]
1937,33186337,Acceptability of a Tenofovir Disoproxil Fumarate Intravaginal Ring for HIV Pre-Exposure Prophylaxis Among Sexually Active Women.,"INTRODUCTION


Vaginal ring delivery of antiretroviral drugs may provide protection against acquisition of HIV-1 when used as Pre-Exposure prophylaxis. As part of a randomized placebo-controlled safety trial of a tenofovir disoproxil fumarate (TDF) intravaginal ring (IVR), we assessed product acceptability through surveys of women after continuous ring use.
METHODS


Sexually active, HIV-negative women were enrolled to investigate the safety and pharmacokinetics of 3 months of continuous TDF IVR use. The study was designed to include 40 US participants randomly assigned (3:1) to a TDF or placebo IVR. Twelve were randomized to TDF and 5 to the placebo group before the study was electively discontinued because of the development of vaginal ulcerations in 8 women in the TDF group. Acceptability data were gathered via self-administered, computer-based questionnaires.
RESULTS


The average age of the 17 participants was 31 years (range, 18-42 years). Sixteen participants (94%) completed all questions at 2 study visits. When asked about ring likeability after 1 month of ring use, 12 (75%) of 16 reported overall liking the ring, including 6 (75%) of 8 who developed ulcerations. In addition, 10 (83%) of 12 who had their menses during the first month of ring use were not bothered by the ring, and 11 (69%) of 16 stated that the ring was not bothersome with use during sex.
CONCLUSIONS


Despite unanticipated ulcers, TDF and placebo IVRs were acceptable to some women, even when used with menses and during sex, which is promising for continued development of IVRs for HIV prevention.",2020,"Despite unanticipated ulcers, TDF and placebo IVRs were acceptable to some women, even when used with menses and during sex, which is promising for continued development of IVRs for HIV prevention.","['17 participants was 31 years (range, 18-42 years', 'Sexually active, HIV-negative women', '8 women in the TDF group', '40 US participants randomly assigned (3:1) to a', 'surveys of women after continuous ring use', 'Sexually Active Women', 'Sixteen participants (94%) completed all questions at 2 study visits']","['Tenofovir Disoproxil Fumarate Intravaginal Ring for HIV Pre-Exposure Prophylaxis', 'TDF', 'placebo', 'TDF or placebo IVR', 'tenofovir disoproxil fumarate (TDF) intravaginal ring (IVR']",['vaginal ulcerations'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0566951', 'cui_str': 'Vaginal ulcer'}]",12.0,0.120894,"Despite unanticipated ulcers, TDF and placebo IVRs were acceptable to some women, even when used with menses and during sex, which is promising for continued development of IVRs for HIV prevention.","[{'ForeName': 'April', 'Initials': 'A', 'LastName': 'Dobkin', 'Affiliation': 'From the Departments of Medicine.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McWalters', 'Affiliation': 'From the Departments of Medicine.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Barnett', 'Affiliation': 'From the Departments of Medicine.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Ray', 'Affiliation': 'From the Departments of Medicine.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Espinoza', 'Affiliation': 'From the Departments of Medicine.'}, {'ForeName': 'Aileen P', 'Initials': 'AP', 'LastName': 'McGinn', 'Affiliation': 'From the Departments of Medicine.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': ""Obstetrics and Gynecology and Women's Health Albert Einstein College of Medicine, Bronx, NY.""}, {'ForeName': 'Marla J', 'Initials': 'MJ', 'LastName': 'Keller', 'Affiliation': 'From the Departments of Medicine.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001254']
1938,33186338,"Sexual Behavior and Sexually Transmitted Infection Outcomes Among Men Who Have Sex With Men and Transgender Women Participating in a Study of the Timing of Antiretroviral Therapy in Lima, Peru.","BACKGROUND


We assessed sexual behavior and incidence of sexually transmitted infections (STIs) among men who have sex with men and transgender women participating in Sabes, a study of an expanded treatment as prevention strategy focused on early diagnosis and treatment of HIV infection in Lima, Peru (2013-2017).
METHODS


Sabes participants were tested monthly for HIV to identify acute or early infections, and HIV-positive participants were randomized to receive antiretroviral therapy immediately (immediate arm) or after 24 weeks (deferred arm) during a 48-week follow-up period. Sexual behavior was assessed at randomization (baseline) and every 12 weeks thereafter. Participants were tested for urethral and rectal chlamydia and gonorrhea and for syphilis at baseline, 12, 24, and 48 weeks. We describe patterns of sexual behavior during the 48-week follow-up period and compare sexual behavior and STI incidence between study arms.
RESULTS


After randomization, 207 HIV-positive participants completed questionnaires and STI testing at 2 or more visits. After HIV diagnosis, participants in both arms reported increases in condom use with main and casual partners and decreased drug and alcohol use before or during anal sex. We observed no between-arm differences in sexual behavior. Deferred arm participants had higher incidence of chlamydia (incidence rate ratio, 2.33; 95% confidence interval, 1.14-4.77) but not gonorrhea or syphilis.
CONCLUSIONS


Despite reported increases in condom use, the overall high incidence of STIs reflects some ongoing condomless sex among HIV-positive men who have sex with men and transgender women, highlighting the importance of regular STI screening and counseling to support consistent condom use among HIV-positive individuals at risk for STIs.",2020,"Deferred arm participants had higher incidence of chlamydia (incidence rate ratio, 2.33; 95% confidence interval, 1.14-4.77) but not gonorrhea or syphilis.
","['Participants were tested for urethral and rectal chlamydia and gonorrhea and for syphilis at baseline, 12, 24, and 48 weeks', 'HIV-positive men who have sex with men and transgender women', 'Who Have Sex With Men and Transgender Women Participating in a Study of the Timing of Antiretroviral Therapy in Lima, Peru', 'Sabes participants were tested monthly for HIV to identify acute or early infections, and HIV-positive participants', 'Men', 'men who have sex with men and transgender women participating in Sabes']",['antiretroviral therapy'],"['sexual behavior', 'condom use with main and casual partners and decreased drug and alcohol use', 'Sexual Behavior and Sexually Transmitted Infection Outcomes', 'incidence of chlamydia', 'Sexual behavior', 'sexual behavior and STI incidence']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}]",,0.226954,"Deferred arm participants had higher incidence of chlamydia (incidence rate ratio, 2.33; 95% confidence interval, 1.14-4.77) but not gonorrhea or syphilis.
","[{'ForeName': 'Michalina A', 'Initials': 'MA', 'LastName': 'Montaño', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Alfaro', 'Affiliation': 'Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Lima, Perú.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Ness', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Ganoza', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Perú.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Perú.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sanchez', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Perú.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'Asociación Civil Impacta Salud y Educación, Lima, Perú.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Duerr', 'Affiliation': 'From the Department of Epidemiology, University of Washington, Seattle, WA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001310']
1939,33186365,"Advance care planning in patients with advanced cancer: A 6-country, cluster-randomised clinical trial.","BACKGROUND


Advance care planning (ACP) supports individuals to define, discuss, and record goals and preferences for future medical treatment and care. Despite being internationally recommended, randomised clinical trials of ACP in patients with advanced cancer are scarce.
METHODS AND FINDINGS


To test the implementation of ACP in patients with advanced cancer, we conducted a cluster-randomised trial in 23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015-2018. Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0-3, and at least 3 months life expectancy were eligible. The ACTION Respecting Choices ACP intervention as offered to patients in the intervention arm included scripted ACP conversations between patients, family members, and certified facilitators; standardised leaflets; and standardised advance directives. Control patients received care as usual. Main outcome measures were quality of life (operationalised as European Organisation for Research and Treatment of Cancer [EORTC] emotional functioning) and symptoms. Secondary outcomes were coping, patient satisfaction, shared decision-making, patient involvement in decision-making, inclusion of advance directives (ADs) in hospital files, and use of hospital care. In all, 1,117 patients were included (442 intervention; 675 control), and 809 (72%) completed the 12-week questionnaire. Patients' age ranged from 18 to 91 years, with a mean of 66; 39% were female. The mean number of ACP conversations per patient was 1.3. Fidelity was 86%. Sixteen percent of patients found ACP conversations distressing. Mean change in patients' quality of life did not differ between intervention and control groups (T-score -1.8 versus -0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making. Specialist palliative care (37% versus 27%, p = 0.002) and AD inclusion in hospital files (10% versus 3%, p < 0.001) were more likely in the intervention group. A key limitation of the study is that recruitment rates were lower in intervention than in control hospitals.
CONCLUSIONS


Our results show that quality of life effects were not different between patients who had ACP conversations and those who received usual care. The increased use of specialist palliative care and AD inclusion in hospital files of intervention patients is meaningful and requires further study. Our findings suggest that alternative approaches to support patient-centred end-of-life care in this population are needed.
TRIAL REGISTRATION


ISRCTN registry ISRCTN63110516.",2020,"Mean change in patients' quality of life did not differ between intervention and control groups (T-score -1.8 versus -0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making.","['1,117 patients were included (442 intervention; 675 control), and 809 (72%) completed the 12-week questionnaire', ""Patients' age ranged from 18 to 91 years, with a mean of 66; 39% were female"", 'patients with advanced cancer', 'Patients with advanced lung (stage III/IV) or colorectal (stage IV) cancer, WHO performance status 0-3, and at least 3 months life expectancy were eligible', '23 hospitals across Belgium, Denmark, Italy, Netherlands, Slovenia, and United Kingdom in 2015-2018']","['ACP', 'Advance care planning']","['coping, patient satisfaction, shared decision-making, patient involvement in decision-making, inclusion of advance directives (ADs) in hospital files, and use of hospital care', 'quality of life (operationalised as European Organisation for Research and Treatment of Cancer [EORTC] emotional functioning) and symptoms', 'AD inclusion in hospital files', 'mean number of ACP conversations', 'symptoms, coping, patient satisfaction, and shared decision-making', 'quality of life effects', 'quality of life', 'Specialist palliative care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0030699', 'cui_str': 'Client participation'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}]",1117.0,0.126665,"Mean change in patients' quality of life did not differ between intervention and control groups (T-score -1.8 versus -0.8, p = 0.59), nor did changes in symptoms, coping, patient satisfaction, and shared decision-making.","[{'ForeName': 'Ida J', 'Initials': 'IJ', 'LastName': 'Korfage', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Carreras', 'Affiliation': 'Clinical Epidemiology, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Arnfeldt Christensen', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pascalle', 'Initials': 'P', 'LastName': 'Billekens', 'Affiliation': 'Laurens, Rotterdam, Netherlands.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bramley', 'Affiliation': 'Institute of Nursing and Midwifery Care Excellence, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Briggs', 'Affiliation': 'Respecting Choices, C-TAC Innovations, Oregon, Wisconsin, United States of America.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bulli', 'Affiliation': 'Clinical Epidemiology, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Glenys', 'Initials': 'G', 'LastName': 'Caswell', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Červ', 'Affiliation': 'University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.'}, {'ForeName': 'Johannes J M', 'Initials': 'JJM', 'LastName': 'van Delden', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Dunleavy', 'Affiliation': 'International Observatory on End of Life Care, Division of Health Research, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Eecloo', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gorini', 'Affiliation': 'Clinical Epidemiology, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Mogens', 'Initials': 'M', 'LastName': 'Groenvold', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bud', 'Initials': 'B', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, C-TAC Innovations, Oregon, Wisconsin, United States of America.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ingravallo', 'Affiliation': 'Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy.'}, {'ForeName': 'Lea J', 'Initials': 'LJ', 'LastName': 'Jabbarian', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Marijke C', 'Initials': 'MC', 'LastName': 'Kars', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kodba-Čeh', 'Affiliation': 'University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.'}, {'ForeName': 'Urska', 'Initials': 'U', 'LastName': 'Lunder', 'Affiliation': 'University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Miccinesi', 'Affiliation': 'Clinical Epidemiology, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Alenka', 'Initials': 'A', 'LastName': 'Mimić', 'Affiliation': 'University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.'}, {'ForeName': 'Polona', 'Initials': 'P', 'LastName': 'Ozbič', 'Affiliation': 'University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.'}, {'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Payne', 'Affiliation': 'International Observatory on End of Life Care, Division of Health Research, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Polinder', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Pollock', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Preston', 'Affiliation': 'International Observatory on End of Life Care, Division of Health Research, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Seymour', 'Affiliation': 'Health Sciences School, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Simonič', 'Affiliation': 'University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Thit Johnsen', 'Affiliation': 'Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Toccafondi', 'Affiliation': 'Clinical Epidemiology, Oncological Network, Prevention and Research Institute (ISPRO), Florence, Italy.'}, {'ForeName': 'Mariëtte N', 'Initials': 'MN', 'LastName': 'Verkissen', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilcock', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Zwakman', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'van der Heide', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Judith A C', 'Initials': 'JAC', 'LastName': 'Rietjens', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Netherlands.'}]",PLoS medicine,['10.1371/journal.pmed.1003422']
1940,33186740,"Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial.","BACKGROUND


The phase III SANDPIPER study assessed taselisib (GDC-0032), a potent, selective PI3K inhibitor, plus fulvestrant in estrogen receptor-positive, HER2-negative, PIK3CA-mutant locally advanced or metastatic breast cancer.
PATIENTS AND METHODS


Postmenopausal women with disease recurrence/progression during/after an aromatase inhibitor were randomized 2:1 to receive taselisib (4 mg; taselisib arm) or placebo (placebo arm) plus fulvestrant (500 mg). Stratification factors were visceral disease, endocrine sensitivity, and geographic region. Patients with PIK3CA-mutant tumors (central cobas® PIK3CA Mutation Test), were randomized separately from those without detectable mutations. The primary endpoint was investigator-assessed progression-free survival (INV-PFS) in patients with PIK3CA-mutant tumors. Secondary endpoints included objective response rate, overall survival, clinical benefit rate, duration of objective response, PFS by blinded independent central review (BICR-PFS), safety, and time to deterioration in health-related quality of life.
RESULTS


The PIK3CA-mutant intention-to-treat population comprised 516 patients (placebo arm: n = 176; taselisib arm: n = 340). INV-PFS was significantly improved in the taselisib (7.4 months [95% CI, 7.26-9.07]) vs placebo arm (5.4 months [95% CI, 3.68-7.29]) (stratified HR 0.70; 95% CI, 0.56-0.89; P = 0.0037) and confirmed by BICR-PFS (HR 0.66). Secondary endpoints, including objective response rate, clinical benefit rate, and duration of objective response, showed consistent improvements in the taselisib arm. Safety was assessed in all randomized patients who received at least one dose of taselisib/placebo or fulvestrant regardless of PIK3CA-mutation status (n = 629). Serious adverse events were lower in the placebo vs taselisib arm (8.9% vs 32.0%). There were more discontinuations (placebo arm: 2.3%; taselisib arm: 16.8%) and dose reductions (placebo arm: 2.3%; taselisib arm: 36.5%) in the taselisib arm.
CONCLUSION


SANDPIPER met its primary endpoint; however, the combination of taselisib plus fulvestrant has no clinical utility given its safety profile and modest clinical benefit.",2020,"INV-PFS was significantly improved in the taselisib (7.4 months [95% CI, 7.26-9.07]) vs placebo arm (5.4 months [95% CI, 3.68-7.29]) (stratified HR 0.70; 95% CI, 0.56-0.89; P = 0.0037) and confirmed by BICR-PFS (HR 0.66).","['Postmenopausal women with disease recurrence/progression during/after an aromatase inhibitor', 'estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer', 'patients with PIK3CA-mutant tumors', '516 patients (placebo arm: n = 176; taselisib arm: n = 340', 'Patients with PIK3CA-mutant tumors (central cobas® PIK3CA Mutation Test', 'regardless of PIK3CA-mutation status (n = 629']","['taselisib', 'placebo (placebo arm) plus fulvestrant', 'taselisib/placebo or fulvestrant', 'placebo', 'taselisib or placebo with fulvestrant']","['Safety', 'visceral disease, endocrine sensitivity, and geographic region', 'objective response rate, overall survival, clinical benefit rate, duration of objective response, PFS by blinded independent central review (BICR-PFS), safety, and time to deterioration in health-related quality of life', 'Serious adverse events', 'INV-PFS', 'objective response rate, clinical benefit rate, and duration of objective response', 'investigator-assessed progression-free survival (INV-PFS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",629.0,0.802757,"INV-PFS was significantly improved in the taselisib (7.4 months [95% CI, 7.26-9.07]) vs placebo arm (5.4 months [95% CI, 3.68-7.29]) (stratified HR 0.70; 95% CI, 0.56-0.89; P = 0.0037) and confirmed by BICR-PFS (HR 0.66).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dent', 'Affiliation': 'The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quiron Group, Madrid & Barcelona, Spain; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Institut Curie, Paris, France; Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department Gynecology and Obstetrics and CCCMunich, LMU University Hospital, Munich, Germany.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Wilson', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Schimmoller', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Hsu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'IRCCS Istituto Nazionale Tumori ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sousa', 'Affiliation': 'Instituto Português de Oncologia do Porto FG, Porto, Portugal.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Drullinsky', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Memorial Hospital, New York, NY.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Jacot', 'Affiliation': ""Institut du Cancer de Montpellier (ICM) Val d'Aurelle, Montpellier University, Montpellier, France. Electronic address: william.jacot@icm.unicancer.fr.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.596']
1941,33187076,Effectiveness of a Group-Based Progressive Strength Training in Primary Care to Improve the Recurrence of Low Back Pain Exacerbations and Function: A Randomised Trial.,"Low back pain (LBP) is the leading cause of disability and one of the most common reasons for physician visits in primary care, with a 33% rate of recurrence during the first year. However, the most optimal exercise program in this context remains unknown. The objective was to evaluate the effectiveness of a group-based progressive strength training program in non-specific chronic LBP (CLBP) patients in primary care on pain recurrence and physical function. Eighty-five patients with non-specific CLBP were separated into two groups (Intervention group: completed a progressive strength training program 3 days per week for 8 weeks; Control group: received the usual care). The intervention group showed a recurrence rate of 8.3%, while the control group had a recurrence rate of 33.3% and a shorter time until the first recurrent episode. The intervention group showed increased lumbar extensor strength, left-hand handgrip strength, and reduced the number of pain sites compared with the control group. Results also showed greater odds for reducing LBP intensity and disability in the intervention group. In conclusion, a group-based progressive strength training program is a more effective and efficient alternative than Back-School programs and can easily be carried out in the primary health care context.",2020,"The intervention group showed a recurrence rate of 8.3%, while the control group had a recurrence rate of 33.3% and a shorter time until the first recurrent episode.","['Eighty-five patients with non-specific CLBP', 'non-specific chronic LBP (CLBP) patients in primary care on pain recurrence and physical function']","['Group-Based Progressive Strength Training', 'progressive strength training program', 'group-based progressive strength training program']","['LBP intensity and disability', 'Recurrence of Low Back Pain Exacerbations and Function', 'lumbar extensor strength, left-hand handgrip strength', 'recurrence rate', 'number of pain sites']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",85.0,0.0246677,"The intervention group showed a recurrence rate of 8.3%, while the control group had a recurrence rate of 33.3% and a shorter time until the first recurrent episode.","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Guzmán-González', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago 8380419, Chile.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cruz-Montecinos', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago 8380419, Chile.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Morell', 'Affiliation': 'Primary Care Health Department Valencia Arnau-Llíria, 46015 Valencia, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Roldán', 'Affiliation': 'Primary Care Health Department Valencia Arnau-Llíria, 46015 Valencia, Spain.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228326']
1942,33187084,Effects of a Community-Based Pilot Intervention on Home Food Availability among U.S. Households.,"The purpose of this study was to assess the effects of a pilot community-based behavioral intervention on the home food environment in U.S. households. Parents (21 females, 2 males; age = 36 ± 5.5 years; 78% Hispanic) of elementary school-aged children attended a 10-week dietary improvement behavioral intervention targeting an increase in fruit and vegetable consumption and a reduction in sugar intake. Home food availability of fruit, vegetables, and sugar-laden foods and beverages were assessed before and after the intervention using a modified version of the Home Food Inventory. Relative to baseline, the intervention resulted in significant increases in fruit availability (7.7 ± 3.2 items vs. 9.4 ± 3.1 items;  p  = 0.004) and low sugar cereal (2.3 ± 1.4 types vs. 2.7 ± 1.4 types;  p  = 0.033). There was a significant reduction in sugar-sweetened beverage availability (3.2 ± 1.9 types vs. 1.7 ± 1.3 types;  p  = 0.004). There was a significant increase in the number of households with accessible ready-to-eat vegetables and fruit, and a significant reduction in available prepared desserts, and candy ( p  < 0.01). There were no significant changes in the availability of vegetables and sugar-laden cereals. The current intervention resulted in positive changes in the home food environment. Further research to confirm these results in a randomized controlled trial is warranted.",2020,"There was a significant increase in the number of households with accessible ready-to-eat vegetables and fruit, and a significant reduction in available prepared desserts, and candy ( p  < 0.01).","['Parents (21 females, 2 males; age = 36 ± 5.5 years; 78% Hispanic) of elementary school-aged children attended a', 'Home Food Availability among U.S. Households', 'U.S. households']","['Community-Based Pilot Intervention', '10-week dietary improvement behavioral intervention targeting an increase in fruit and vegetable consumption and a reduction in sugar intake', 'pilot community-based behavioral intervention']","['availability of vegetables and sugar-laden cereals', 'sugar-sweetened beverage availability', 'Home food availability of fruit, vegetables, and sugar-laden foods and beverages', 'fruit availability', 'number of households with accessible ready-to-eat vegetables and fruit']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",,0.0324245,"There was a significant increase in the number of households with accessible ready-to-eat vegetables and fruit, and a significant reduction in available prepared desserts, and candy ( p  < 0.01).","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Cassinat', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bruening', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'School of Public Health, San Diego State University, 9245 Sky Park Ct. Suite 224, San Diego, CA 92123, USA.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Gutiérrez', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix, Parks and Recreation Department, 212 E. Alta Vista Rd., Phoenix, AZ 85402, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17228327']
1943,33187089,Resveratrol Improves Heart Function by Moderating Inflammatory Processes in Patients with Systolic Heart Failure.,"The effects of resveratrol (RES) in heart failure have already been evaluated in animal models; however, in human clinical trials, they have not been confirmed yet. The aim of this study was to assess the effects of resveratrol treatment in systolic heart failure patients (heart failure with reduced ejection fraction or HFrEF). In this human clinical trial, 60 outpatients with NYHA (New York Heart Association) class II-III HFrEF were enrolled and randomized into two groups: receiving either 100-mg resveratrol daily or placebo for three months. At the beginning and at the end of the study echocardiography, a six-minute walk test, spirometry, quality of life questionnaire, lab test and RNA profile analysis were performed. The systolic and diastolic left ventricular function, as well as the global longitudinal strain, were improved significantly in the resveratrol-treated group (RES). Exercise capacity, ventilation parameters and quality of life also improved significantly in the RES group. In parallel, the cardiac biomarker levels (N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and galectin-3) decreased in the treated group. The level of inflammatory cytokines decreased significantly after RES supplementation, as a consequence of the decreased expression level of leucocyte electron transport chain proteins. The main findings of our trial are that RES treatment added to the standard heart failure therapy improved heart function and the clinical condition by moderating the inflammatory processes in patients with HFrEF.",2020,"The systolic and diastolic left ventricular function, as well as the global longitudinal strain, were improved significantly in the resveratrol-treated group (RES).","['Patients with Systolic Heart Failure', 'systolic heart failure patients (heart failure with reduced ejection fraction or HFrEF', 'patients with HFrEF', '60 outpatients with NYHA (New York Heart Association', 'class II-III HFrEF']","['resveratrol treatment', '100-mg resveratrol daily or placebo', 'resveratrol (RES']","['heart function', 'Exercise capacity, ventilation parameters and quality of life', 'cardiac biomarker levels (N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and galectin-3', 'systolic and diastolic left ventricular function', 'spirometry, quality of life questionnaire, lab test and RNA profile analysis', 'level of inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0301817', 'cui_str': 'Prohormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",60.0,0.0463392,"The systolic and diastolic left ventricular function, as well as the global longitudinal strain, were improved significantly in the resveratrol-treated group (RES).","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Deres', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Orsolya', 'Initials': 'O', 'LastName': 'Horvath', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Eros', 'Affiliation': 'Szentágothai Research Centre, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sandor', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Szentágothai Research Centre, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Szilvia', 'Initials': 'S', 'LastName': 'Soos', 'Affiliation': 'Division of Pulmonology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Marton', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Sumegi', 'Affiliation': 'Szentágothai Research Centre, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Habon', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Halmosi', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9111108']
1944,33188886,Dual Vasopressin Receptor Antagonism to Improve Congestion in Patients With Acute Heart Failure: Design of the AVANTI Trial.,"BACKGROUND


Loop diuretics are the main treatment for patients with acute heart failure, but are associated with neurohormonal stimulation and worsening renal function and do not improve long-term outcomes. Antagonists to arginine vasopressin may provide an alternative strategy to avoid these effects. The AVANTI study will investigate the efficacy and safety of pecavaptan, a novel, balanced dual-acting V1a/V2 vasopressin antagonist, both as adjunctive therapy to loop diuretics after admission for acute heart failure, and later as monotherapy.
METHODS AND RESULTS


AVANTI is a double-blind, randomized phase II study in 571 patients hospitalized with acute heart failure and signs of persistent congestion before discharge. In part A, patients will receive either pecavaptan 30 mg/d or placebo with standard of care for 30 days. In part B, eligible patients will continue treatment or receive pecavaptan or diuretics as monotherapy for another 30 days. The primary end points for part A are changes in body weight and serum creatinine; for part B, changes in body weight and blood urea nitrogen/creatinine ratio.
CONCLUSIONS


This study will provide the first evidence that a balanced V1a/V2 antagonist may safely enhance decongestion, both as an adjunct to loop diuretics and as an alternative strategy.
TRIAL REGISTRATION NUMBER


NCT03901729.",2020,"The primary endpoints for Part A are changes in body weight and serum creatinine; for Part B, changes in body weight and blood urea nitrogen/creatinine ratio.
","['With Acute Heart Failure', '571 patients hospitalized with acute HF and signs of persistent congestion prior to discharge', 'Patients', 'patients with acute heart failure (HF']","['pecavaptan', 'Dual Vasopressin Receptor Antagonism', 'pecavaptan or diuretics', 'pecavaptan 30\xa0mg daily or placebo', 'arginine vasopressin']","['changes in body weight and serum creatinine; for Part B, changes in body weight and blood urea nitrogen/creatinine ratio']","[{'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0078077', 'cui_str': 'Vasopressin Receptor'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0201922', 'cui_str': 'BUN/Creatinine ratio'}]",571.0,0.187494,"The primary endpoints for Part A are changes in body weight and serum creatinine; for Part B, changes in body weight and blood urea nitrogen/creatinine ratio.
","[{'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Goldsmith', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burkhoff', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York, USA.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Voors', 'Affiliation': 'Department of Cardiology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'University of Lorraine, Inserm CIC-P 1433, CHRU de Nancy, Inserm U1116, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'Bayer AG, Research and Development, Preclinical Research, Heart and Vascular Disease, Wuppertal, Germany.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Staedtler', 'Affiliation': 'Bayer AG, Research and Development, Pharmaceuticals, TA Statistics 1 CNTH, Berlin, Germany.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Colorado', 'Affiliation': 'Bayer US LLC Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Dinh', 'Affiliation': 'Bayer AG, Research and Development, Pharmaceuticals, Translational Sciences, Translational Medicine, Experimental Medicine CV, Wuppertal, Germany; Centre for Clinical Medicine, University Faculty of Health, University of Witten Herdecke, Witten, Germany.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Udelson', 'Affiliation': 'Division of Cardiology and the CardioVascular Centre, Tufts Medical Center, Boston, Massachusetts, USA. Electronic address: JUdelson@tuftsmedicalcenter.org.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.10.007']
1945,33188930,Causal inference methods for small non-randomized studies: Methods and an application in COVID-19.,"The usual development cycles are too slow for the development of vaccines, diagnostics and treatments in pandemics such as the ongoing SARS-CoV-2 pandemic. Given the pressure in such a situation, there is a risk that findings of early clinical trials are overinterpreted despite their limitations in terms of size and design. Motivated by a non-randomized open-label study investigating the efficacy of hydroxychloroquine in patients with COVID-19, we describe in a unified fashion various alternative approaches to the analysis of non-randomized studies. A widely used tool to reduce the impact of treatment-selection bias are so-called propensity score (PS) methods. Conditioning on the propensity score allows one to replicate the design of a randomized controlled trial, conditional on observed covariates. Extensions include the g-computation approach, which is less frequently applied, in particular in clinical studies. Moreover, doubly robust estimators provide additional advantages. Here, we investigate the properties of propensity score based methods including three variations of doubly robust estimators in small sample settings, typical for early trials, in a simulation study. R code for the simulations is provided.",2020,"The usual development cycles are too slow for the development of vaccines, diagnostics and treatments in pandemics such as the ongoing SARS-CoV-2 pandemic.",['patients with COVID-19'],['hydroxychloroquine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.10542,"The usual development cycles are too slow for the development of vaccines, diagnostics and treatments in pandemics such as the ongoing SARS-CoV-2 pandemic.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Humboldtallee 32, 37073 Göttingen, Germany. Electronic address: sarah.friedrich@med.uni-goettingen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Humboldtallee 32, 37073 Göttingen, Germany. Electronic address: tim.friede@med.uni-goettingen.de.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106213']
1946,33188988,Efficacy of inhaled budesonide on serum inflammatory factors and quality of life among children with acute infectious laryngitis.,"OBJECTIVE


Acute infectious laryngitis is commonly occurred among children. Our study sought to investigate the effect of inhaled budesonide on among children with acute infectious laryngitis.
METHODS


A total of 92 children with acute infectious laryngitis were randomly allocated to either the study (46 cases, treated with inhaled budesonide) and control group (46 cases, treated with dexamethasone). The disappearance time of symptoms, therapeutic effect and adverse reactions were observed in the two groups.
RESULTS


The therapeutic effect was significantly better in the study group than in the control group (97.83% vs 82.61%). After 3 days of treatment, the disappearance time of symptoms, such as hoarseness/barking cough, singing sound in the throat, three-concave sign and dyspnea in the study group was significantly less than that in the control group (P < 0.05). The levels of IL-4, IL-17, MMP-9, IL-33, IFN-γ and IgE in the two groups decreased, and evidently lower levels were found in the study group as compared to the control group (P < 0.05).
CONCLUSION


Inhaled budesonide exerted obvious better effect in terms of reducing serum inflammatory factors and improving the quality of life with safety profile.",2020,"The levels of IL-4, IL-17, MMP-9, IL-33, IFN-γ and IgE in the two groups decreased, and evidently lower levels were found in the study group as compared to the control group (P < 0.05).
","['children with acute infectious laryngitis', 'children', '92 children with acute infectious laryngitis']","['dexamethasone', 'budesonide', 'inhaled budesonide']","['therapeutic effect', 'disappearance time of symptoms, such as hoarseness/barking cough, singing sound in the throat, three-concave sign and dyspnea', 'serum inflammatory factors and quality of life', 'serum inflammatory factors', 'quality of life with safety profile', 'disappearance time of symptoms, therapeutic effect and adverse reactions', 'levels of IL-4, IL-17, MMP-9, IL-33, IFN-γ and IgE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001327', 'cui_str': 'Acute laryngitis'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0234866', 'cui_str': 'Barking cough'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C1667752', 'cui_str': 'IL33 protein, human'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}]",92.0,0.0334823,"The levels of IL-4, IL-17, MMP-9, IL-33, IFN-γ and IgE in the two groups decreased, and evidently lower levels were found in the study group as compared to the control group (P < 0.05).
","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': ""Department of ENT, Wuhan Children's Hospital (Wuhan Maternal and Child Health Care Hospital), Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.""}, {'ForeName': 'Zhong-Fang', 'Initials': 'ZF', 'LastName': 'Xia', 'Affiliation': ""Department of ENT, Wuhan Children's Hospital (Wuhan Maternal and Child Health Care Hospital), Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.""}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory Medicine, Wuhan Children's Hospital (Wuhan Maternal and Child Health Care Hospital), Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China. Electronic address: 41466110@qq.com.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102820']
1947,33189049,Dose distribution correction for the influence of magnetic field using a deep convolutional neural network for online MR-guided adaptive radiotherapy.,"PURPOSE


This study aimed to develop a deep convolutional neural network (CNN)-based dose distribution conversion approach for the correction of the influence of a magnetic field for online MR-guided adaptive radiotherapy.
METHODS


Our model is based on DenseNet and consists of two 2D input channels and one 2D output channel. These three types of data comprise dose distributions without a magnetic field (uncorrected), electron density (ED) maps, and dose distributions with a magnetic field. These data were generated as follows: both types of dose distributions were created using 15-field IMRT in the same conditions except for the presence or absence of a magnetic field with the GPU Monte Carlo dose in Monaco version 5.4; ED maps were acquired with planning CT images using a clinical CT-to-ED table at our institution. Data for 50 prostate cancer patients were used; 30 patients were allocated for training, 10 for validation, and 10 for testing using 4-fold cross-validation based on rectum gas volume. The accuracy of the model was evaluated by comparing 2D gamma-indexes against the dose distributions in each irradiation field with a magnetic field (true).
RESULTS


The gamma indexes in the body for CNN-corrected uncorrected dose against the true dose were 94.95% ± 4.69% and 63.19% ± 3.63%, respectively. The gamma indexes with 2%/2-mm criteria were improved by 10% in most test cases (99.36%).
CONCLUSIONS


Our results suggest that the CNN-based approach can be used to correct the dose-distribution influences with a magnetic field in prostate cancer treatment.",2020,Our results suggest that the CNN-based approach can be used to correct the dose-distribution influences with a magnetic field in prostate cancer treatment.,['50 prostate cancer patients were used; 30 patients'],[],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],50.0,0.0301308,Our results suggest that the CNN-based approach can be used to correct the dose-distribution influences with a magnetic field in prostate cancer treatment.,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kajikawa', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kadoya', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: kadoya.n@rad.med.tohoku.ac.jp.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Nemoto', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Radiotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriyoshi', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Department of Medical Physics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Katsuta', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Dobashi', 'Affiliation': 'Department of Radiological Technology, School of Health Sciences, Faculty of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Department of Radiological Technology, School of Health Sciences, Faculty of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Jingu', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB),['10.1016/j.ejmp.2020.11.002']
1948,33192191,The Effect of Massage With and Without Aromatic Oil on Delirium After Open-Heart Surgery: A Randomized Controlled Trial.,"Objective


The current study aimed to determine the effect of massage with and without aromatic oil on the delirium of patients hospitalized in the cardiac intensive care unit.
Methods


This study was a single-blind, randomized, controlled trial. Using a convenience method, 150 patients were selected and assigned into 3 groups: control, massage with aroma, and massage without aroma using the minimization method. Only routine care was provided for the control group. Brown massage with 4% rose oil in the base of sweet almond oil was given to the massage group with aroma 1 day after the surgery. The same steps and massage techniques with sweet almond oil were performed for the massage group without aroma. The incidence and severity of delirium were evaluated at the end of each day using the Neelon and Champagne Confusion Scale.
Results


Delirium scores were not significantly different among the 3 groups on the first, second, and third days ( P  > .05). Also, the incidence of delirium significantly decreased in all 3 groups from day 1 to day 3.
Conclusion


The results of this study could not prove the beneficial effects of massage with and without aroma on delirium incidence. Further studies are suggested to determine the best intervention to reduce delirium in patients undergoing coronary artery surgery.",2020,"Results


Delirium scores were not significantly different among the 3 groups on the first, second, and third days ( P  > .05).","['150 patients were selected and assigned into 3 groups', 'patients undergoing coronary artery surgery', 'patients hospitalized in the cardiac intensive care unit']","['Open-Heart Surgery', 'massage with and without aromatic oil', 'Massage With and Without Aromatic Oil', 'control, massage with aroma, and massage without aroma using the minimization method']","['Delirium scores', 'incidence of delirium', 'incidence and severity of delirium', 'Delirium']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0190188', 'cui_str': 'Operative procedure on coronary artery'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}]","[{'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",150.0,0.0645918,"Results


Delirium scores were not significantly different among the 3 groups on the first, second, and third days ( P  > .05).","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Askarkafi', 'Affiliation': 'Critical Care ward, Afshar Hospital, Yazd University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rayyani', 'Affiliation': 'Nursing Research Center, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Kerman, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Kerman, Iran.'}]",Journal of chiropractic medicine,['10.1016/j.jcm.2019.08.001']
1949,33192244,"The Effect and Optimal Dosage of Dexmedetomidine Plus Sufentanil for Postoperative Analgesia in Elderly Patients With Postoperative Delirium and Early Postoperative Cognitive Dysfunction: A Single-Center, Prospective, Randomized, Double-Blind, Controlled Trial.","Background


Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are common complications after major surgery among elderly patients. Dexmedetomidine (DEX) is less frequently explored for its effects in patients with postoperative neurocognitive disorders. This study investigated the effect and optimal dosage of DEX for patient-controlled analgesia (PCA) on POD and early POCD after major surgery among elderly patients.
Methods


Patients in four groups received continuous infusion of DEX 0, 100, 200, and 400 μg with sufentanil 150 μg for PCA immediately after surgery. POD and POCD were assessed on postoperative days 1, 2, 3, and 7 by using the Confusion Assessment Method (CAM) and Mini-Mental State Examination (MMSE) scales. Furthermore, the incidence of POD and POCD of all the four groups in postoperative 7 days classified by high risk factors (age, education, surgical site, and surgical category), sedation level, postoperative pain intensity, and side effects were assessed.
Results


The overall incidence rates of POD and early POCD 7 days after surgery were lower in the DEX 200 μg 400 μg groups than in the DEX 0 μg and 100 μg groups ( P  < 0.05). Compared with DEX 200 μg, DEX 400 μg reduced early POCD in patients who underwent open surgery ( P  < 0.05). There were no intergroup differences in the postoperative sedation level, pain intensity, and side effects.
Conclusion


The continuous infusion of DEX 200 μg or DEX 400 μg in PCA significantly decreased the incidence of POD and early POCD after major surgery without increasing any side effects. Compared with DEX 200 μg, DEX 400 μg was preferred for reducing early POCD in patients who underwent open surgery.",2020,"Compared with DEX 200 μg, DEX 400 μg reduced early POCD in patients who underwent open surgery ( P  < 0.05).","['Elderly Patients With Postoperative Delirium and Early Postoperative Cognitive Dysfunction', 'patient-controlled analgesia (PCA) on POD and early POCD after major surgery among elderly patients', 'elderly patients', 'patients with postoperative neurocognitive disorders', 'patients who underwent open surgery']","['sufentanil', 'continuous infusion of DEX', 'DEX', 'Dexmedetomidine Plus Sufentanil', 'DEX 200 μg or DEX', 'Dexmedetomidine (DEX']","['postoperative sedation level, pain intensity, and side effects', 'POD and POCD', 'overall incidence rates of POD and early POCD', 'high risk factors (age, education, surgical site, and surgical category), sedation level, postoperative pain intensity, and side effects', 'incidence of POD and early POCD', 'early POCD', 'incidence of POD and POCD', 'Confusion Assessment Method (CAM) and Mini-Mental State Examination (MMSE) scales', '\n\n\nPostoperative delirium (POD) and postoperative cognitive dysfunction (POCD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.382476,"Compared with DEX 200 μg, DEX 400 μg reduced early POCD in patients who underwent open surgery ( P  < 0.05).","[{'ForeName': 'Wenshuai', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Heilongjiang Provincial Corps Hospital, Chinese People's Armed Police Forces, Harbin, China.""}, {'ForeName': 'Xifan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital, Harbin Medical University, Harbin, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.549516']
1950,33192365,Quantifying Human Avoidance Behavior in Immersive Virtual Reality.,"Avoidance behavior is a key symptom of most anxiety disorders and a central readout in animal research. However, the quantification of real-life avoidance behavior in humans is typically restricted to clinical populations, who show actual avoidance of phobic objects. In experimental approaches for healthy participants, many avoidance tasks utilize button responses or a joystick navigation on the screen as indicators of avoidance behavior. To allow the ecologically valid assessment of avoidance behavior in healthy participants, we developed a new automated immersive Virtual Reality paradigm, where participants could freely navigate in virtual 3-dimensional, 360-degrees scenes by real naturalistic body movements. A differential fear conditioning procedure was followed by three newly developed behavioral tasks to assess participants' avoidance behavior of the conditioned stimuli: an approach, a forced-choice, and a search task. They varied in instructions, degrees of freedom, and high or low task-related relevance of the stimuli. We initially examined the tasks in a quasi-experiment ( N  = 55), with four consecutive runs and various experimental adaptations. Here, although we observed avoidance behavior in all three tasks after additional reinforcement, we only detected fear-conditioned avoidance behavior in the behavioral forced-choice and search tasks. These findings were largely replicated in a confirmatory experiment ( N  = 72) with randomized group allocation, except that fear-conditioned avoidance behavior was only manifest in the behavioral search task. This supports the notion that the behavioral search task is sensitive to detect avoidance behavior after fear conditioning only, whereas the behavioral approach and forced-choice tasks are still able to detect ""strong"" avoidance behavior after fear conditioning and additional reinforcement.",2020,"A differential fear conditioning procedure was followed by three newly developed behavioral tasks to assess participants' avoidance behavior of the conditioned stimuli: an approach, a forced-choice, and a search task.",['healthy participants'],[],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],[],72.0,0.0279876,"A differential fear conditioning procedure was followed by three newly developed behavioral tasks to assess participants' avoidance behavior of the conditioned stimuli: an approach, a forced-choice, and a search task.","[{'ForeName': 'Florian P', 'Initials': 'FP', 'LastName': 'Binder', 'Affiliation': 'Department of Translational Research in Psychiatry, Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Victor I', 'Initials': 'VI', 'LastName': 'Spoormaker', 'Affiliation': 'Department of Translational Research in Psychiatry, Max Planck Institute of Psychiatry, Munich, Germany.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2020.569899']
1951,33192377,Immediate Effects of Anodal Transcranial Direct Current Stimulation on Postural Stability Using Computerized Dynamic Posturography in People With Chronic Post-stroke Hemiparesis.,"Postural stability is commonly decreased in individuals with chronic post-stroke hemiparesis due to multisystemic deficits. Transcranial direct current stimulation (tDCS) is a non-invasive method to modulate cortical excitability, inducing neuroplastic changes to the targeted cortical areas and has been suggested to potentially improve motor functions in individuals with neurological impairments. The purpose of this double-blinded, sham-controlled study was to examine the acute effects of anodal tDCS over the lesioned motor cortex leg area with concurrent limits of stability training on postural control in individuals with chronic post-stroke hemiparesis. Ten individuals with chronic post-stroke hemiparesis received either anodal or sham tDCS stimulation over the lesioned leg region of the motor cortex while undergoing 20 min of postural training. The type of stimulation to receive during the first session was pseudorandomized, and the two sessions were separated by 14 days. Before and immediately after 20 min of tDCS, the 10 m walk test, the Berg Balance Scale, and dynamic posturography assessments were performed. After a single session of anodal tDCS with concurrent postural training, we observed no changes in clinical measures of balance and walking, assessed using the Berg Balance Scale and 10 m walk test. For dynamic posturography assessments, participants demonstrated improvements in adaptation responses to toes-up and toes-down perturbations, regardless of the type of tDCS received. Additionally, improved performance in the shifting center of gravity was observed during anodal tDCS. Taken together, these preliminary findings suggest that tDCS can potentially be used as a feasible approach be incorporated into the rehabilitation of chronic post-stroke individuals with issues related to postural control and fear of falling, and that multiple sessions of tDCS stimulation may be needed to improve functional measures of postural control and walking.",2020,"For dynamic posturography assessments, participants demonstrated improvements in adaptation responses to toes-up and toes-down perturbations, regardless of the type of tDCS received.","['individuals with neurological impairments', 'People With Chronic Post-stroke Hemiparesis', 'Ten individuals with chronic post-stroke hemiparesis', 'individuals with chronic post-stroke hemiparesis due to multisystemic deficits', 'individuals with chronic post-stroke hemiparesis']","['Transcranial direct current stimulation (tDCS', 'anodal or sham tDCS stimulation over the lesioned leg region of the motor cortex while undergoing 20 min of postural training', 'anodal tDCS with concurrent postural training', 'Anodal Transcranial Direct Current Stimulation', 'anodal tDCS', 'Computerized Dynamic Posturography', 'tDCS', 'stability training']","['Postural Stability', 'Berg Balance Scale, and dynamic posturography assessments', 'adaptation responses', 'Postural stability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3665421', 'cui_str': 'Structure of subregion of lower limb'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",10.0,0.0295503,"For dynamic posturography assessments, participants demonstrated improvements in adaptation responses to toes-up and toes-down perturbations, regardless of the type of tDCS received.","[{'ForeName': 'Jing Nong', 'Initials': 'JN', 'LastName': 'Liang', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, Las Vegas, NV, United States.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Ubalde', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, Las Vegas, NV, United States.'}, {'ForeName': 'Jordon', 'Initials': 'J', 'LastName': 'Jacklin', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, Las Vegas, NV, United States.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Hobson', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, Las Vegas, NV, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wright-Avila', 'Affiliation': 'Department of Physical Therapy, University of Nevada, Las Vegas, Las Vegas, NV, United States.'}, {'ForeName': 'Yun-Ju', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Industrial Engineering and Engineering Management, National Tsing Hua University, Hsinchu, Taiwan.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00341']
1952,33192379,The Association Between Amygdala Subfield-Related Functional Connectivity and Stigma Reduction 12 Months After Social Contacts: A Functional Neuroimaging Study in a Subgroup of a Randomized Controlled Trial.,"Social contact is one of the best methods for reducing stigma, and the effect may be associated with emotional response and social cognition. The amygdala is a key region of these functions and can be divided into three subregions, each of which has a different function and connectivity. We investigated whether the amygdala subregion-related functional connectivity is associated with the effect of anti-stigma interventions on reducing mental health-related stigma in a randomized controlled trial (RCT) over 12 months. Healthy young adults [ n  = 77, age, mean ( SD ) = 21.23 (0.94) years; male,  n  = 48], who were subsampled from an RCT ( n  = 259) investigating the effect of anti-stigma interventions, using filmed social contacts (FSC) or internet self-learning (INS), on reducing stigma, underwent 10 min resting-state functional magnetic resonance imaging between the trial registration and 12 months follow-up. The extent of stigma was assessed at the baseline, post-intervention and 12 month follow-up surveys, using the Japanese-language version of the Social Distance Scale (SDSJ), to assess negative emotional attitude toward people with schizophrenia. We compared associations between amygdala subregion-related functional connectivity and changes in the SDSJ scores for 12 months across the control, INS, and FSC groups. Associations between the change in stigma for 12 months and the superficial (SF) subregion of the amygdala-related connectivity in the intracalcarine cortex [(x, y, z) = (-8, -66, 12), z = 4.21,  P   FWE-corrected  = 0.0003, cluster size = 192] differed across groups. The  post hoc  analysis showed that the SF-intracalcarine cortex connectivity was negatively correlated with the change in stigma only in the FSC group. The current results indicate that greater SF-intracalcarine cortex connectivity is associated with a better response to the FSC interventions, suggesting that biological variability could underlie the long-term effect of anti-stigma interventions on stigma in the real world.",2020,The  post hoc  analysis showed that the SF-intracalcarine cortex connectivity was negatively correlated with the change in stigma only in the FSC group.,"['After Social Contacts', 'Healthy young adults [ n  = 77, age, mean ( SD ) = 21.23 (0.94', ' years; male,  n  = 48], who were subsampled from an RCT ( n  = 259']","['Japanese-language version of the Social Distance Scale (SDSJ', 'anti-stigma interventions, using filmed social contacts (FSC) or internet self-learning (INS), on reducing stigma, underwent 10 min resting-state functional magnetic resonance imaging', 'anti-stigma interventions']","['SF-intracalcarine cortex connectivity', 'change in stigma', 'SDSJ scores', 'mental health-related stigma']","[{'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517487', 'cui_str': '0.94'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0037412', 'cui_str': 'Social Distance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0237101', 'cui_str': 'Social interaction finding'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0751586,The  post hoc  analysis showed that the SF-intracalcarine cortex connectivity was negatively correlated with the change in stigma only in the FSC group.,"[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'University of Tokyo Center for Integrative Science of Human Behavior (CiSHuB), Tokyo, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Okada', 'Affiliation': 'The International Research Center for Neurointelligence (WPI-IRCN), Institutes for Advanced Study (UTIAS), University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Neuropsychiatry, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazusa', 'Initials': 'K', 'LastName': 'Ohta', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Art and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Department of Psychiatric Rehabilitation, National Center of Neurology and Psychiatry, National Institute of Mental Health, Kodaira, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Abe', 'Affiliation': 'Department of Radiology, Graduate School of Medicine, University of Tokyo, Bunkyo City, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kunimatsu', 'Affiliation': 'Department of Radiology, IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Minato City, Japan.'}, {'ForeName': 'Sosei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Psychiatric Rehabilitation, National Center of Neurology and Psychiatry, National Institute of Mental Health, Kodaira, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Kasai', 'Affiliation': 'University of Tokyo Center for Integrative Science of Human Behavior (CiSHuB), Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koike', 'Affiliation': 'University of Tokyo Center for Integrative Science of Human Behavior (CiSHuB), Tokyo, Japan.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00356']
1953,33199796,Resistance training decreases plasma levels of adipokines in postmenopausal women.,"Physical inactivity and the onset of menopause increase the risk of cardiovascular disease amongst postmenopausal women. We aim to investigate the effect of resistance training (RT) on plasma levels of selected cytokines, adipokines, myokines, and sex hormones in postmenopausal women with vasomotor symptoms. This was a sub-study of a randomised controlled trial investigating the effects of RT on vasomotor symptoms in postmenopausal women. Women were randomised to join a 15-week RT program (n = 26) or remain sedentary as control (n = 29). Venous blood samples were taken at week-0 and week-15 for all participants. Enzyme-linked immunosorbent assays and multiple bead assays were used to measure cytokines, adipokines, myokines, and sex hormones in plasma. Plasma measurements of 16 of 33 analytes were within detectable limits. After adjusting for good compliance in the RT group (58% of RT participants), after 15 weeks, significantly lower plasma levels of adiponectin (p < 0.001), lipocalin-2 (p < 0.01) and resistin (p = 0.04) were found. Comparing control and RT women, using change-over-time values, significant increases in median testosterone and sex hormone binding globulin levels were seen in RT women. RT intervention lowers the levels of adipokines, particularly adiponectin, in postmenopausal women with vasomotor symptoms. These results were secondary outcomes of a clinical trial, and further investigations in a larger cohort are essential with the additional control of diet control and body composition analyses. Nevertheless, our study shows RT may be a beneficial intervention in reducing inflammation amongst postmenopausal women.",2020,This was a sub-study of a randomised controlled trial investigating the effects of RT on vasomotor symptoms in postmenopausal women.,"['postmenopausal women with vasomotor symptoms', 'postmenopausal women']","['RT intervention', 'resistance training (RT', '15-week RT program (n\u2009=\u200926) or remain sedentary as control', 'RT', 'Resistance training']","['median testosterone and sex hormone binding globulin levels', 'levels of adipokines, particularly adiponectin', 'plasma levels of adiponectin', 'Venous blood samples', 'Plasma measurements', 'plasma levels of selected cytokines, adipokines, myokines, and sex hormones', 'lipocalin-2', 'vasomotor symptoms', 'Physical inactivity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]",,0.0436589,This was a sub-study of a randomised controlled trial investigating the effects of RT on vasomotor symptoms in postmenopausal women.,"[{'ForeName': 'Liam J', 'Initials': 'LJ', 'LastName': 'Ward', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. liam.ward@ki.se.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hammar', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Lindh-Åstrand', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Berin', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lindblom', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anna-Clara', 'Initials': 'AC', 'LastName': 'Spetz Holm', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. wei.li@liu.se.'}]",Scientific reports,['10.1038/s41598-020-76901-w']
1954,33200002,Efficacy and prognosis of surgical treatment in ARMM and its effects on immune and inflammatory profiles.,"The aim of the present study was to investigate the efficacy and prognosis of surgical treatment in anorectal malignant melanoma (ARMM) as well as its effects on immune and inflammatory profiles. A total of 64 patients with ARMM were enrolled and divided into control group (n=32) and observation group (n=32) based on different therapeutic methods. Patients in the observation group underwent wide local excision, while those in the control group were given non-surgical treatment. The immune function was compared between the two groups after treatment. The expression levels of serum IL-17, IL-23 and vascular endothelial growth factor (VEGF) were compared between the groups before and after treatment. Patients were followed up for 5 years to observe the recurrence and survival rates in the two groups. Compared with those in the control group, the levels of cluster of differentiation (CD)3 + , CD4 +  and CD4 + /CD8 +  were increased, while the level of CD8 +  was reduced in the observation group (P<0.05). The levels of serum IL-17, IL-23 and VEGF were significantly lower in both groups at 4, 6 and 8 weeks after treatment than those before treatment, and the decrease was more obvious in the observation group (P<0.05). The observation group exhibited a notably elevated 5-year survival rate and a remarkably decreased recurrence rate in comparison with the control group (P<0.05). For ARMM, surgical treatment is more effective than non-surgical treatment, which has less effect on immune function, is able to reduce serum IL-17, IL-23 and VEGF levels, lower recurrence rate, improve patient survival rate, and plays a certain positive role in prolonging the survival time of ARMM patients.",2020,"The levels of serum IL-17, IL-23 and VEGF were significantly lower in both groups at 4, 6 and 8 weeks after treatment than those before treatment, and the decrease was more obvious in the observation group (P<0.05).","['64 patients with ARMM were enrolled and divided into control group (n=32) and observation group (n=32) based on different therapeutic methods', 'anorectal malignant melanoma (ARMM']","['control group were given non-surgical treatment', 'wide local excision']","['recurrence and survival rates', 'patient survival rate', 'serum IL-17, IL-23 and VEGF levels, lower recurrence rate', 'level of CD8 ', 'levels of cluster of differentiation (CD)3 + , CD4 +  and CD4 + /CD8 ', 'levels of serum IL-17, IL-23 and VEGF', 'expression levels of serum IL-17, IL-23 and vascular endothelial growth factor (VEGF', 'immune function', 'recurrence rate', '5-year survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0278259', 'cui_str': 'Local excision'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0439234', 'cui_str': 'year'}]",64.0,0.0287415,"The levels of serum IL-17, IL-23 and VEGF were significantly lower in both groups at 4, 6 and 8 weeks after treatment than those before treatment, and the decrease was more obvious in the observation group (P<0.05).","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Huan', 'Affiliation': 'Operating Room, Linyi Cancer Hospital, Linyi, Shandong 276000, P.R. China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': 'Outpatient Department, Linyi Cancer Hospital, Linyi, Shandong 276000, P.R. China.'}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Breast Surgery, Linyi Cancer Hospital, Linyi, Shandong 276000, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9407']
1955,33200031,Comparison of efficacy of dexamethasone and methylprednisolone in moderate to severe covid 19 disease.,"Background


The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Various treatment options were being tried all over the world. Some studies showed beneficial effects of corticosteroids in covid 19. Hence, we designed this study to compare the effect of two steroids in moderate to severe covid 19 disease.
Objectives


To compare the efficacy and safety of dexamethasone and methylprednisolone in moderate to severe covid 19 disease.
Study Settings


Fatima Memorial Hospital, Lahore and Ganga Ram hospital, Lahore.
Study Design


Quasi experimental, interventional study.
Duration of Study


From 1st June 2020 to 30th June 2020.
Methodology


Sample size and technique : there were total 100 patients; 35 patients received dexamethasone and 65 were kept in methylprednisolone receiving group.
Results


The mean age of patients was 57.91 years in dexamethasone group and 54.86 years in methylprednisolone group. In dexamethasone group, there were 15 (42.8%) critically ill patients who were shifted to Intensive care unit (ICU) and seven (20%) of them needed ventilatory support, whereas in methylprednisolone group 22 (33.8%) had to be admitted in ICU with eight (12.3%) patient needing ventilator. As outcome measure, patients in both the groups showed marked improvement in temperature, oxygen requirement and C-reactive protein (CRP) on day 5. Only six (17.1%) patient died who received dexamethasone while 10 (15.3%) patients died among those receiving methylprednisolone.
Conclusion


Dexamethasone and methylprednisolone both are equally effective in treating moderate to severe covid 19 disease.",2020,"Only six (17.1%) patient died who received dexamethasone while 10 (15.3%) patients died among those receiving methylprednisolone.
","['moderate to severe covid 19 disease', 'total 100 patients; 35 patients received', 'Duration of Study\n\n\nFrom 1st June 2020 to 30th June 2020', 'severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019']","['dexamethasone and methylprednisolone', 'dexamethasone', 'methylprednisolone', 'Dexamethasone and methylprednisolone']","['efficacy and safety', 'temperature, oxygen requirement and C-reactive protein (CRP', 'Fatima Memorial Hospital, Lahore and Ganga Ram hospital, Lahore']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}]",,0.0269134,"Only six (17.1%) patient died who received dexamethasone while 10 (15.3%) patients died among those receiving methylprednisolone.
","[{'ForeName': 'Syeda Arzinda', 'Initials': 'SA', 'LastName': 'Fatima', 'Affiliation': 'Department of Medicine, Fatima Memorial Hospital, Lahore, Pakistan.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Asif', 'Affiliation': 'Resident Internal Medicine, Fatima Memorial Hospital, Lahore, Pakistan.'}, {'ForeName': 'Khurshid A', 'Initials': 'KA', 'LastName': 'Khan', 'Affiliation': 'Fellow American Board of Medicine and Endocrinology, Fatima Memorial Hospital, Lahore, Pakistan.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Siddique', 'Affiliation': 'Department of Medicine, Sir Ganga Ram Hospital, Lahore, Pakistan.'}, {'ForeName': 'Aijaz Zeeshan', 'Initials': 'AZ', 'LastName': 'Khan', 'Affiliation': 'Fatima Memorial Hospital, Lahore, Pakistan.'}]",Annals of medicine and surgery (2012),['10.1016/j.amsu.2020.11.027']
1956,33200213,Pulmonary vein isolation alone vs. more extensive ablation with defragmentation and linear ablation of persistent atrial fibrillation: the EARNEST-PVI trial.,"AIMS


Previous studies could not demonstrate any benefit of more intensive ablation in addition to pulmonary vein isolation (PVI) including complex fractionated atrial electrogram (CFAE) and linear ablation for recurrence in the initial catheter ablation of persistent atrial fibrillation (AF). This study aimed to establish the non-inferiority of PVI alone to PVI plus these additional ablation strategies.
METHODS AND RESULTS


Patients with persistent AF who underwent an initial catheter ablation (n = 512, long-standing persistent AF; 128 cases) were randomly assigned in a 1:1 ratio to either PVI alone (PVI-alone group) or PVI plus CFAE and/or linear ablation (PVI-plus group). After excluding 15 cases who did not receive procedures, we analysed 249 and 248 patients, respectively. The primary endpoint was recurrence of AF, atrial flutter, and/or atrial tachycardia, and the non-inferior margin was set at a hazard ratio of 1.43. In the PVI-plus group, 85.1% of patients had linear ablation and 15.3% CFAE ablation. After 12 months, freedom from the primary endpoint occurred in 71.3% of patients in the PVI-alone group and in 78.3% in the PVI-plus group [hazard ratio = 1.56 (95% confidence interval: 1.10-2.24), non-inferior P = 0.3062]. The procedure-related complication rates were 2.0% in the PVI-alone group and 3.6% in the PVI-plus group (P = 0.199).
CONCLUSION


This randomized trial did not establish the non-inferiority of PVI alone to PVI plus linear ablation or CFAE ablation in patients with persistent AF, but implied that the PVI plus strategy was promising to improve the clinical efficacy (NCT03514693).",2020,"This randomized trial did not establish the non-inferiority of PVI alone to PVI plus linear ablation or CFAE ablation in patients with persistent AF, but implied that the PVI plus strategy was promising to improve the clinical efficacy (NCT03514693).","['patients with persistent AF', 'persistent atrial fibrillation', 'Patients with persistent AF who underwent an initial catheter ablation (n\u2009=\u2009512, long-standing persistent AF; 128 cases']","['Pulmonary vein isolation alone vs. more extensive ablation with defragmentation and linear ablation', 'complex fractionated atrial electrogram (CFAE) and linear ablation', 'PVI alone to PVI plus linear ablation or CFAE ablation', 'PVI alone (PVI-alone group) or PVI plus CFAE and/or linear ablation (PVI-plus group']","['procedure-related complication rates', 'recurrence of AF, atrial flutter, and/or atrial tachycardia, and the non-inferior margin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C2350882', 'cui_str': 'Atrial Electrogram'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",,0.0893291,"This randomized trial did not establish the non-inferiority of PVI alone to PVI plus linear ablation or CFAE ablation in patients with persistent AF, but implied that the PVI plus strategy was promising to improve the clinical efficacy (NCT03514693).","[{'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Shungo', 'Initials': 'S', 'LastName': 'Hikoso', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Masaharu', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Division of Cardiology, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Egami', 'Affiliation': 'Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Division of Cardiology, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Minamiguchi', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Cardiovascular Medicine, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Oka', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawasaki', 'Affiliation': 'Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Department of Cardiology, Osaka Hospital, Japan Community Healthcare Organization, Osaka, Japan.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Division of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Dohi', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Sunaga', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Mizuno', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Nakatani', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Cardiovascular Center, Sakurabashi-Watanabe Hospital, 2-4-32 Umeda, Kita-ku, Osaka 530-0001, Japan.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa293']
1957,33200233,Time-dependent discrepancies between physician-assessed and patient-reported oxaliplatin-induced peripheral neuropathy in patients with metastatic colorectal cancer who received mFOLFOX6 plus bevacizumab: a post hoc analysis (WJOG4407GSS2).,"PURPOSE


Cumulative sensory neurotoxicity induced by oxaliplatin impairs patients' quality of life and treatment continuation. This study investigated the relationship between physician-assessed and patient-reported oxaliplatin-induced peripheral neuropathy (OIPN) during treatment of metastatic colorectal cancer (mCRC) over time.
METHODS


A post hoc analysis was conducted for 191 patients with mCRC who received mFOLFOX6 plus bevacizumab in the WJOG4407G trial. Physician-assessed OIPN was graded by CTCAE every 2 weeks. Patient-reported OIPN was assessed with the FACT/GOG-Ntx (11 items, best score 44) at baseline and at 3, 6, and 9 months. Physician underestimation was defined as when the highest scores of the NTX1-4 sensory subscale/CTCAE grade were 2/0, 3/0-1, or 4/0-1, and overestimation as 0/2-3, 1/2-3, or 2/3.
RESULTS


The median total dose (range) of oxaliplatin was 762 (85-5950) mg/m 2 . Overall, the least squares mean of FACT/GOG-Ntx scores (standard error), estimated by a linear mixed model, were 36 (0.8), 34 (0.9), 29 (1.0), and 27 (1.1) for CTCAE grades 0, 1, 2, and 3, respectively. FACT/GOG-Ntx scores were weakly-to-moderately correlated with CTCAE grade (Spearman's r = - 0.24 [p = 0.0026], - 0.46 [p < 0.0001], and - 0.56 [p < 0.0001] at 3, 6, and 9 months, respectively). OIPN was underestimated in 85/159 (54%), 43/109 (39%), and 18/69 (26%) patients at 3, 6, and 9 months, respectively. In contrast, OIPN was overestimated in less than 5% of the patients at any time.
CONCLUSION


During early treatment, physician underestimation of OIPN in patients with mCRC is likely.",2020,"FACT/GOG-Ntx scores were weakly-to-moderately correlated with CTCAE grade (Spearman's r = - 0.24 [p = 0.0026], - 0.46 [p < 0.0001], and - 0.56 [p < 0.0001] at 3, 6, and 9 months, respectively).","['patients with metastatic colorectal cancer', '191 patients with mCRC who received']","['oxaliplatin-induced peripheral neuropathy (OIPN', 'mFOLFOX6 plus bevacizumab', 'oxaliplatin']","['OIPN', 'FACT/GOG-Ntx scores', 'FACT/GOG-Ntx scores (standard error']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",191.0,0.0961219,"FACT/GOG-Ntx scores were weakly-to-moderately correlated with CTCAE grade (Spearman's r = - 0.24 [p = 0.0026], - 0.46 [p < 0.0001], and - 0.56 [p < 0.0001] at 3, 6, and 9 months, respectively).","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miura', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan. yujmiura@mac.com.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05891-2']
1958,33200245,"Ultrasound-guided adductor canal block combined with lateral femoral cutaneous nerve block for post-operative analgesia following total knee arthroplasty: a prospective, double-blind, randomized controlled study.","PURPOSE


The purpose of this study was to investigate whether adductor canal block (ACB) combined with lateral femoral cutaneous nerve block (LFCNB) could improve the efficacy of post-operative analgesia in a comparison with a standard peri-articular infiltration analgesia (PIA) after a total knee arthroplasty (TKA).
METHODS


One hundred and sixty patients of scheduled unilateral primary TKA were randomly allocated into two groups for post-operative analgesia. Eighty cases were treated with ACB combined with LFCNB and the other eighty treated with PIA. The primary outcomes were pain visual analogue scale (VAS) and rescue pain killer consumption, and the secondary outcomes were knee active range of motion (ROM), quadriceps strength, patients' ambulation ability, Knee Society Score (KSS), length of hospital stay, and adverse events.
RESULTS


We found that ACB combined with LFCNB was better on decreasing the post-operative pain score within 12 hours at rest and 8 h with activity (p < 0.05) and provided longer duration of analgesia (19.91 ± 5.09 VS 12.06 ± 3.67 h, p < 0.01) and less rescue morphine consumption (13.63 ± 9.84 vs 18.00 ± 11.52 mg, p = 0.011) than the PIA. There was no significant difference between the two groups (p > 0.05) in terms of knee ROM, quadriceps strength, daily mobilization distance, KSS, and complication occurrence.
CONCLUSIONS


ACB combined with LFCNB provides a significantly better pain control, less opioid consumption, and longer duration of analgesia than peri-articular infiltration while preserving muscle function without affecting knee functional recovery nor the length of stay or side effects occurrence.",2020,"There was no significant difference between the two groups (p > 0.05) in terms of knee ROM, quadriceps strength, daily mobilization distance, KSS, and complication occurrence.
","['One hundred and sixty patients of scheduled unilateral primary TKA', 'a comparison with a standard peri-articular infiltration analgesia (PIA) after a total knee arthroplasty (TKA', 'total knee arthroplasty']","['PIA', 'Ultrasound-guided adductor canal block combined with lateral femoral cutaneous nerve block for post-operative analgesia', 'ACB combined with LFCNB', 'adductor canal block (ACB) combined with lateral femoral cutaneous nerve block (LFCNB', 'LFCNB', 'ACB']","['knee ROM, quadriceps strength, daily mobilization distance, KSS, and complication occurrence', 'post-operative pain score', 'rescue morphine consumption', 'pain control, less opioid consumption, and longer duration of analgesia', 'longer duration of analgesia', ""pain visual analogue scale (VAS) and rescue pain killer consumption, and the secondary outcomes were knee active range of motion (ROM), quadriceps strength, patients' ambulation ability, Knee Society Score (KSS), length of hospital stay, and adverse events""]","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394740', 'cui_str': 'Local anesthetic lateral femoral cutaneous nerve block'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",80.0,0.192959,"There was no significant difference between the two groups (p > 0.05) in terms of knee ROM, quadriceps strength, daily mobilization distance, KSS, and complication occurrence.
","[{'ForeName': 'Donghai', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alqwbani', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Zhouyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, Sichuan Province, China.'}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Guoxue Road, Chengdu, 610041, People's Republic of China. kangpd@163.com.""}]",International orthopaedics,['10.1007/s00264-020-04549-2']
1959,33200257,"Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis.","Odanacatib (ODN) was investigated as an osteoporosis treatment in 292 men. Compared with placebo, odanacatib improved bone mineral density and led to sustained bone resorption decreases while producing relatively little bone formation reduction that leveled off with time. However, increased risk of stroke in another study stopped further odanacatib development.
INTRODUCTION


ODN, a selective oral cathepsin K inhibitor, was in development for osteoporosis treatment. This phase 3, double-blind, randomized, placebo-controlled, 24-month study investigated ODN safety and efficacy in men with osteoporosis.
METHODS


Men with idiopathic osteoporosis or osteoporosis due to hypogonadism and a lumbar spine or hip (total hip [TH], femoral neck [FN], or trochanter) bone mineral density (BMD) T-score of ≤ - 2.5 to ≥ - 4.0 without prior vertebral fracture or ≤ - 1.5 to ≥ - 4.0 with one prior vertebral fracture were randomized (1:1) to once-weekly ODN 50 mg or placebo. All received 5600 IU vitamin D 3  weekly and calcium supplementation as needed (≥ 1200 mg daily). The primary efficacy outcome was changed from baseline in lumbar spine BMD versus placebo.
RESULTS


Overall, 292 men, mean age 68.8 years, were randomly assigned to ODN or placebo. Versus placebo, ODN increased BMD from baseline at the lumbar spine, TH, FN, and trochanter by 5.6%, 2.0%, 1.7%, and 2.1%, respectively (all p < 0.01), and decreased uNTx/Cr (68%, p < 0.001), sCTx (77%, p < 0.001), sP1NP (16%, p = 0.001), and sBSAP (8%, p = 0.019). The between-group bone formation marker decrease peaked at 3 months, then returned toward baseline. The safety profile, including cardiovascular events, was similar between groups.
CONCLUSION


Though a promising osteoporosis therapy for men, ODN development was discontinued due to increased risk of stroke in the LOFT phase 3 trial.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01120600 (registered May 11, 2010).",2020,"Versus placebo, ODN increased BMD from baseline at the lumbar spine, TH, FN, and trochanter by 5.6%, 2.0%, 1.7%, and 2.1%, respectively (all p < 0.01), and decreased uNTx/Cr (68%, p < 0.001), sCTx (77%, p < 0.001), sP1NP (16%, p = 0.001), and sBSAP (8%, p = 0.019).","['292 men', 'Men with idiopathic osteoporosis or osteoporosis due to hypogonadism and a lumbar spine or hip (total hip [TH], femoral neck [FN], or trochanter) bone mineral density', '292 men, mean age 68.8\xa0years', 'men with osteoporosis']","['odanacatib', 'ODN 50\xa0mg or placebo', '5600\xa0IU vitamin D 3  weekly and calcium supplementation', 'placebo', 'ODN or placebo']","['bone mineral density', 'uNTx/Cr', 'Odanacatib (ODN', 'lumbar spine BMD', 'sBSAP', 'safety and efficacy', 'sCTx', 'BMD', 'cardiovascular events', 'risk of stroke', 'ODN safety and efficacy', 'sP1NP']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0158447', 'cui_str': 'Idiopathic osteoporosis'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2351970', 'cui_str': 'odanacatib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517812', 'cui_str': '5600'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C2351970', 'cui_str': 'odanacatib'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.548947,"Versus placebo, ODN increased BMD from baseline at the lumbar spine, TH, FN, and trochanter by 5.6%, 2.0%, 1.7%, and 2.1%, respectively (all p < 0.01), and decreased uNTx/Cr (68%, p < 0.001), sCTx (77%, p < 0.001), sP1NP (16%, p = 0.001), and sBSAP (8%, p = 0.019).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Binkley', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. nbinkley@wisc.edu.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Orwoll', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chapurlat', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Hôpital Édouard Herriot, Lyon, France.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Scott', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Giezek', 'Affiliation': 'MSD Europe Inc., Brussels, Belgium.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Santora', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05701-9']
1960,33200303,"Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial.","BACKGROUND


Specific treatment strategies are sorely needed for scirrhous-type gastric cancer still, which has poor prognosis. Based on the promising results of our previous phase II study (JCOG0210), we initiated a phase III study to confirm the efficacy of neoadjuvant chemotherapy (NAC) in type 4 or large type 3 gastric cancer.
METHODS


Patients aged 20-75 years without a macroscopic unresectable factor as confirmed via staging laparoscopy were randomly assigned to surgery followed by adjuvant chemotherapy with S-1 (Arm A) or NAC (S-1plus cisplatin) followed by D2 gastrectomy plus adjuvant chemotherapy with S-1 (Arm B). The primary endpoint was overall survival (OS).
RESULTS


Between October 2005 and July 2013, 316 patients were enrolled, allocating 158 patients to each arm. In Arm B, in which NAC was completed in 88% of patients. Significant downstaging based on tumor depth, lymph node metastasis, and peritoneal cytology was observed using NAC. Excluding the initial 16 patients randomized before the first revision of the protocol, 149 and 151 patients in arms A and B, respectively, were included in the primary analysis. The 3-year OS rates were 62.4% [95% confidence interval (CI)  54.1-69.6] in Arm A and 60.9% (95% CI  52.7-68.2) in Arm B. The hazard ratio of Arm B against Arm A was 0.916 (95% CI  0.679-1.236).
CONCLUSIONS


For type 4 or large type 3 gastric cancer, NAC with S-1 plus cisplatin failed to demonstrate a survival benefit. D2 surgery followed by adjuvant chemotherapy remains the standard treatment.",2020,The 3-year OS rates were 62.4% [95% confidence interval (CI)  54.1-69.6] in Arm A and 60.9% (95% CI  52.7-68.2) in Arm B.,"['Patients aged 20-75\xa0years without a macroscopic unresectable factor as confirmed via staging laparoscopy', 'Between October 2005 and July 2013, 316 patients were enrolled, allocating 158 patients to each arm', 'type 4 or large type 3 gastric cancer']","['adjuvant chemotherapy with S-1', 'cisplatin', 'NAC (S-1plus cisplatin', 'neoadjuvant chemotherapy (NAC', 'D2 gastrectomy plus adjuvant chemotherapy with S-1 (Arm B', 'D2 surgery followed by adjuvant chemotherapy', 'Gastrectomy with or without neoadjuvant S-1 plus cisplatin']","['survival benefit', '3-year OS rates', 'overall survival (OS', 'tumor depth, lymph node metastasis, and peritoneal cytology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}]",316.0,0.153814,The 3-year OS rates were 62.4% [95% confidence interval (CI)  54.1-69.6] in Arm A and 60.9% (95% CI  52.7-68.2) in Arm B.,"[{'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Surgery, IMS Tokyo Katsushika General Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Shuzioka, 411-8777, Japan. m.terashima@scchr.jp.'}, {'ForeName': 'Junki', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Katai', 'Affiliation': 'Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Kaji', 'Affiliation': 'Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Department of Surgery, Gifu Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kurita', 'Affiliation': 'Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Takagi', 'Affiliation': 'Department of Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Sang-Woong', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of General and Gastroenterological Surgery, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': 'Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hihara', 'Affiliation': 'Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sano', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Sasako', 'Affiliation': 'Department of Surgery, Yodogawa Christian Hospital, Osaka, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01136-7']
1961,33200413,Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.,"OBJECTIVE


Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting.
METHODS


This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days.
RESULTS


Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
CONCLUSION


Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.",2020,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
","['Eligible participants spoke English and owned a smartphone', 'adults with migraine and 4+ headache days/month', '139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7\xa0±\xa012.8 years', 'Migraine in Primary Care']","['RELAXaHEAD', 'Smartphone-Delivered Progressive Muscle Relaxation', 'PMR and the other without PMR', 'progressive muscle relaxation (PMR) delivered by a smartphone application (app']","['disability scores', 'moderate-severe disability', 'feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels', 'mean MIDAS scores', 'Migraine Disability Assessment Scale (MIDAS) scores']","[{'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}]",139.0,0.0933415,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Padikkala', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sumaiya', 'Initials': 'S', 'LastName': 'Tasneem', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine Faculty Group Practices, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Powers', 'Affiliation': ""Behavioral Medicine, Headache Medicine, Clinical Psychology, Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center, Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA.'}]",Headache,['10.1111/head.14010']
1962,33200428,Effects of lacosamide and carbamazepine on lipids in a randomized trial.,"OBJECTIVE


The effects of anticonvulsants on lipids are the subject of considerable concern and investigation, but there are almost no data on this issue from randomized trials. We evaluated serum lipid profiles in adults with newly diagnosed epilepsy, following randomization to lacosamide (LCM) or carbamazepine (CBZ) monotherapy.
METHODS


We analyzed data from a Phase 3, international, randomized, double-blind trial of LCM vs CBZ for the initial treatment of focal epilepsy. Serum lipid profiles in patients not taking lipid-lowering agents and providing blood samples under fasting conditions before treatment, and following 3 or 12 months of treatment with LCM or CBZ at various doses were analyzed.
RESULTS


At 12 months, 271 patients satisfied the inclusion criteria for the analysis. No change was observed in LCM-treated patients for total cholesterol, cholesterol fractions, or triglycerides. CBZ-treated patients showed an increase of 21.1 mg/dL in total cholesterol, 12.6 mg/dL in low-density lipoprotein (LDL) cholesterol, 12.5 mg/dL in non-high density lipoprotein (non-HDL) cholesterol, and 8.5 mg/dL in HDL cholesterol; triglycerides remained unchanged. The proportion of patients with elevated total cholesterol levels (above the upper limit of the reference range) did not change in the LCM treatment group (37.0% at Baseline; 34.8% at 12 months), but increased from 30.8% (at Baseline) to 49.6% (at 12 months) in the CBZ treatment group.
SIGNIFICANCE


This study provides Class II evidence that CBZ elevates serum lipids, whereas LCM has no effect on lipids. It supports LCM as an appropriate choice for new-onset focal epilepsy.",2020,"The proportion of patients with elevated total cholesterol levels (above the upper limit of the reference range) did not change in the LCM treatment group (37.0% at Baseline; 34.8% at 12 months), but increased from 30.8% (at Baseline) to 49.6% (at 12 months) in the CBZ treatment group.
","['271 patients satisfied the inclusion criteria for the analysis', 'adults with newly diagnosed epilepsy, following randomization to lacosamide (LCM) or']","['LCM or CBZ', 'LCM', 'carbamazepine (CBZ) monotherapy', 'lacosamide and carbamazepine', 'LCM vs CBZ', 'CBZ']","['low-density lipoprotein (LDL) cholesterol', 'total cholesterol', 'elevated total cholesterol levels', 'serum lipid profiles', 'HDL cholesterol; triglycerides', 'total cholesterol, cholesterol fractions, or triglycerides', 'Serum lipid profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}]","[{'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",271.0,0.430032,"The proportion of patients with elevated total cholesterol levels (above the upper limit of the reference range) did not change in the LCM treatment group (37.0% at Baseline; 34.8% at 12 months), but increased from 30.8% (at Baseline) to 49.6% (at 12 months) in the CBZ treatment group.
","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mintzer', 'Affiliation': 'Department of Neurology, Jefferson Comprehensive Epilepsy Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steiniger-Brach', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Backer', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Daya', 'Initials': 'D', 'LastName': 'Chellun', 'Affiliation': ""UCB Pharma, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Roebling', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}]",Epilepsia,['10.1111/epi.16745']
1963,33200456,The effect of interpersonal relational role analysis on nursing students' anxiety levels and interpersonal problem-solving orientation.,"PURPOSE


This study has been performed to investigate the effects of the interpersonal relational role analysis (IRRA) on the nursing students' anxiety levels and their interpersonal problem-solving orientation.
DESIGN AND METHODS


This study was conducted with randomized controlled, pre-test-post-test control group design and follow-up test patterns (n = 8).
FINDING


Following the practice of IRRA sessions, the findings showed that IRRA has a positive effect on the anxiety levels and interpersonal problem-solving orientations of nursing students.
PRACTICE IMPLICATIONS


Implementation of this practice, which can also be employed by psychiatric nurses in the clinic, in other samples with repeated measurements, such as in 6-monthly or 12-monthly periods, could contribute to the literature.",2020,"Following the practice of IRRA sessions, the findings showed that IRRA has a positive effect on the anxiety levels and interpersonal problem-solving orientations of nursing students.
","[""nursing students' anxiety levels and interpersonal problem-solving orientation""]","['interpersonal relational role analysis', 'interpersonal relational role analysis (IRRA', 'IRRA']",[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]","[{'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],,0.029957,"Following the practice of IRRA sessions, the findings showed that IRRA has a positive effect on the anxiety levels and interpersonal problem-solving orientations of nursing students.
","[{'ForeName': 'Veysel', 'Initials': 'V', 'LastName': 'Kaplan', 'Affiliation': 'Faculty of Health Sciences, Harran University, Şanlıurfa, Turkey.'}, {'ForeName': 'Gülsüm', 'Initials': 'G', 'LastName': 'Ançel', 'Affiliation': 'Faculty of Nursing, Ankara University, Ankara, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12672']
1964,33200487,Majority of people with type 1 diabetes and multiple daily insulin injection benefit by using Continuous Glucose Monitoring: An analysis based on the GOLD randomised trial (GOLD-5).,"AIMS


The aim of this study was to identify responders to continuous glucose monitoring (CGM) in relation to reductions in HbA1c and percentage of time in hypoglycaemia after initiation of CGM for persons with Type 1 Diabetes treated with multiple daily insulin injections.
MATERIALS AND METHODS


We analysed data from 142 persons from the GOLD randomised clinical trial. We evaluated how many improved HbA1c >0.4% (4.7mmol/mol) or decreased their time in Hypoglycaemia/24hrs >20 and >30 minutes, and which baseline variables were associated with these improvements.
RESULTS


Lower reduction of HbA1c was associated with greater reduction of hypoglycaemia r=-0.52 (p< 0.0001). 47% of participants had >0.4% (4.7 mmol/mol) lower HbA1c-values during CGM than with self-measurement of blood-glucose (SMBG) and 47% decreased their time in hypoglycaemia >20 minutes/24 hours. Overall 78% either reduced their HbA1c >0.4% (4.7mmol/mol) or their time in hypoglycaemia >20 minutes/24 hours but only few improved both (14%). Higher HbA1c, lower percentage of time <3.0mmol/l and <3.9mmol/l, lower CV and higher percentage of time >13.9mmol/l (p=0.016), were associated with greater HbA1c reduction during CGM. Variables associated with greater reduction of time in hypoglycaemia were female sex, greater time with glucose levels <3.0mmol/l, higher CV and higher confidence evaluated by hypoglycaemic confidence questionnaire.
CONCLUSION


The majority of people with type 1 diabetes managed by MDI benefit from CGM, some experience a reduced HbA1c whilst others reduced time in hypoglycaemia. These factors need to be considered by health professionals, decision-makers for reimbursement and diabetes guidelines. This article is protected by copyright. All rights reserved.",2020,"RESULTS


Lower reduction of HbA1c was associated with greater reduction of hypoglycaemia r=-0.52 (p< 0.0001).","['persons with Type 1 Diabetes treated with multiple daily insulin injections', 'We analysed data from 142 persons from the GOLD randomised clinical trial']","['continuous glucose monitoring (CGM', 'Continuous Glucose Monitoring']","['blood-glucose (SMBG', 'time in hypoglycaemia', 'hypoglycaemic confidence questionnaire', 'time in Hypoglycaemia/24hrs', 'hypoglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0662611,"RESULTS


Lower reduction of HbA1c was associated with greater reduction of hypoglycaemia r=-0.52 (p< 0.0001).","[{'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Ólafsdóttir', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Uddevalla, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bolinder', 'Affiliation': 'Department of Medicine, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, San Diego, Californa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Department of Clinical Sciences, Lund University, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wijkman', 'Affiliation': 'Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Statistiska Konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ahlén', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Uddevalla, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Schwarcz', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nyström', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hellman', 'Affiliation': 'Department of Medical Sciences, Clinical Diabetes and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'School of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Uddevalla, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14257']
1965,33200488,"The effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.","This study was conducted to determine the effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). The current randomized, double-blind, placebo-controlled trial was conducted among 60 patients with grade 3 DFU. Participants were randomly allocated into two groups (30 participants each group), received either 80 mg nanocurcumin daily for 12 weeks or placebo. Primary endpoints in this study were serum insulin levels and insulin resistance. Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo. Moreover, curcumin intake led to a significant reduction in total- (p < .001), LDL-cholesterol (p < .001), and a significant increase in total antioxidant capacity (TAC) (p < .001) and total glutathione (GSH) (p = .01) compared with the placebo. However, there was no significant improvement in wound healing parameters. Overall, our study demonstrated that nanocurcumin intake in patients with DFU resulted in a significant improvement of glycemic control, total- and LDL-cholesterol, TAC, and GSH but did not affect the indicators of ulcer size.",2020,"Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo.","['60 patients with grade 3 DFU', 'patients with DFU', 'patients with diabetic foot ulcer (DFU', 'patients with diabetic foot ulcer']","['80\u2009mg nanocurcumin daily for 12\u2009weeks or placebo', 'placebo', 'curcumin intake']","['wound healing parameters', 'serum insulin levels and insulin resistance', 'total antioxidant capacity (TAC', 'wound healing and metabolic status', 'total glutathione (GSH', 'LDL-cholesterol', 'insulin resistance', 'fasting plasma glucose', 'glycemic control, total- and LDL-cholesterol, TAC, and GSH', 'insulin sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",60.0,0.355009,"Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razzaghi', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Momen-Heravi', 'Affiliation': 'Department of Infectious Diseases, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6957']
1966,33200489,Fosmetpantotenate Randomized Controlled Trial in Pantothenate Kinase-Associated Neurodegeneration.,"BACKGROUND


Pantothenate kinase-associated neurodegeneration (PKAN) currently has no approved treatments.
OBJECTIVES


The Fosmetpantotenate Replacement Therapy pivotal trial examined whether treatment with fosmetpantotenate improves PKAN symptoms and stabilizes disease progression.
METHODS


This randomized, double-blind, placebo-controlled, multicenter study evaluated fosmetpantotenate, 300 mg oral dose three times daily, versus placebo over a 24-week double-blind period. Patients with pathogenic variants of PANK2, aged 6 to 65 years, with a score ≥6 on the PKAN-Activities of Daily Living (PKAN-ADL) scale were enrolled. Patients were randomized to active (fosmetpantotenate) or placebo treatment, stratified by weight and age. The primary efficacy endpoint was change from baseline at week 24 in PKAN-ADL.
RESULTS


Between July 23, 2017, and December 18, 2018, 84 patients were randomized (fosmetpantotenate: n = 41; placebo: n = 43); all 84 patients were included in the analyses. Six patients in the placebo group discontinued treatment; two had worsening dystonia, two had poor compliance, and two died of PKAN-related complications (aspiration during feeding and disease progression with respiratory failure, respectively). Fosmetpantotenate and placebo group PKAN-ADL mean (standard deviation) scores were 28.2 (11.4) and 27.4 (11.5) at baseline, respectively, and were 26.9 (12.5) and 24.5 (11.8) at week 24, respectively. The difference in least square mean (95% confidence interval) at week 24 between fosmetpantotenate and placebo was -0.09 (-1.69 to 1.51; P = 0.9115). The overall incidence of treatment-emergent serious adverse events was similar in the fosmetpantotenate (8/41; 19.5%) and placebo (6/43; 14.0%) groups.
CONCLUSIONS


Treatment with fosmetpantotenate was safe but did not improve function assessed by the PKAN-ADL in patients with PKAN. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.",2020,"CONCLUSIONS


Treatment with fosmetpantotenate was safe but did not improve function assessed by the PKAN-ADL in patients with PKAN.","['n = 43); all 84 patients were included in the analyses', 'Patients with pathogenic variants of PANK2, aged 6 to 65\u2009years, with a score ≥6 on the PKAN-Activities of Daily Living (PKAN-ADL) scale were enrolled', '2020', 'patients with PKAN', 'Between July 23, 2017, and December 18, 2018, 84 patients were randomized (fosmetpantotenate: n = 41']","['placebo', 'active (fosmetpantotenate) or placebo', 'Fosmetpantotenate and placebo']","['PKAN-ADL mean (standard deviation) scores', 'least square mean', 'PKAN symptoms and stabilizes disease progression', 'worsening dystonia', 'PKAN-ADL', 'overall incidence of treatment-emergent serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018523', 'cui_str': 'Pigmentary pallidal degeneration'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4706037', 'cui_str': 'fosmetpantotenate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4706037', 'cui_str': 'fosmetpantotenate'}]","[{'cui': 'C0018523', 'cui_str': 'Pigmentary pallidal degeneration'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",84.0,0.623879,"CONCLUSIONS


Treatment with fosmetpantotenate was safe but did not improve function assessed by the PKAN-ADL in patients with PKAN.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klopstock', 'Affiliation': 'Friedrich Baur Institute at the Department of Neurology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Videnovic', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Almut Turid', 'Initials': 'AT', 'LastName': 'Bischoff', 'Affiliation': 'Friedrich Baur Institute at the Department of Neurology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bonnet', 'Affiliation': 'Department of Neurology, Sorbonne University, AP-HP Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cif', 'Affiliation': 'Department of Neurosurgery, CHRU de Montpellier, Gui de Chauliac Hospital, Montpellier, France.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Comella', 'Affiliation': 'Department of Neurosurgery and Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Correa-Vela', 'Affiliation': ""Department of Child Neurology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Escolar', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Fraser', 'Affiliation': ""Rare Disease Institute, Division of Genetics and Metabolism, Children's National Medical Center, Washington, District of Columbia, USA.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Neurosurgery, University Hospital of Montpellier, Gui de Chauliac Hospital, Montpellier, France.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Hermanowicz', 'Affiliation': 'Department of Neurology, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jech', 'Affiliation': 'Department of Neurology, First Faculty of Medicine, Charles University and General Faculty Hospital, Prague, Czech Republic.'}, {'ForeName': 'Hyder A', 'Initials': 'HA', 'LastName': 'Jinnah', 'Affiliation': 'Departments of Neurology and Human Genetics, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kmiec', 'Affiliation': ""Child Neurology Department, Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lang', 'Affiliation': ""Edmond J. Safra Program in Parkinson's Disease and the Department of Medicine (Neurology), Toronto Western Hospital and the University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Martí', 'Affiliation': 'Movement Disorders Unit, Hospital Clinic of Barcelona, European Reference Network for Rare Neurological Diseases (ERN-RND), Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED. CB06/05/0018-ISCIII), Barcelona, Spain.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Mercimek-Andrews', 'Affiliation': 'Division of Clinical and Metabolic Genetics, Department of Pediatrics, University of Toronto, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Migvis', 'Initials': 'M', 'LastName': 'Monduy', 'Affiliation': ""Neurology, Nicklaus Children's Hospital, Miami, Florida, USA.""}, {'ForeName': 'Graeme A M', 'Initials': 'GAM', 'LastName': 'Nimmo', 'Affiliation': 'Division of Clinical and Metabolic Genetics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Perez-Dueñas', 'Affiliation': ""Department of Child Neurology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Helle Cecilie Viekilde', 'Initials': 'HCV', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Child Neurology, Oslo University Hospital-Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Planellas', 'Affiliation': 'Department of Neurology, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Roze', 'Affiliation': 'Department of Neurology, Sorbonne University, AP-HP Salpêtrière Hospital, Brain and Spine Institute, Paris, France.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Thakur', 'Affiliation': 'Department of Pediatrics, Division of Child and Adolescent Neurology, University of Texas at Houston Medical School, Houston, Texas, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tochen', 'Affiliation': ""Department of Neurology, Children's National Medical Center, Washington, District of Columbia, USA.""}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Vanegas-Arroyave', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Zorzi', 'Affiliation': 'Department of Child Neurology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Burns', 'Affiliation': 'Biostatistics, Retrophin, Inc., San Diego, California, USA.'}, {'ForeName': 'Feriandas', 'Initials': 'F', 'LastName': 'Greblikas', 'Affiliation': 'Research and Development, Retrophin, Inc., San Diego, California, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28392']
1967,33200512,Factors Affecting the Doses of Roxadustat Versus Darbepoetin Alfa for Anemia Treatment in Hemodialysis Patients.,"Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in chronic kidney disease (CKD). Emerging evidence suggests that roxadustat may be beneficial for patients who inadequately respond to erythropoiesis stimulating agents (ESAs). This post-hoc analysis of a Japanese, double-blind, randomized, phase 3 study in hemodialysis-dependent CKD patients treated with traditional ESAs assessed the impact of factors associated with ESA hyporesponsiveness on roxadustat and darbepoetin alfa (DA) doses required to maintain target hemoglobin. Endpoints included mean of average doses of roxadustat and DA per administration in the last 6 weeks (AAD/6W) by prior ESA resistance index (ERI), iron repletion (transferrin saturation; ferritin), and high-sensitivity C-reactive protein (hs-CRP). Of 415 enrolled patients, 303 were randomized (roxadustat, n=151; DA, n=152). Weight-adjusted AAD/6W increased with increasing ERI for roxadustat (ERI <3.3, 0.89 mg/kg; ERI ≥8.4, 1.51 mg/kg) and DA (ERI <3.3, 0.26 μg/kg; ERI ≥8.4, 0.91 μg/kg); the weight-adjusted AAD/6W relative to within-arm mean AAD/6W showed a trend toward increased DA doses for the ERI ≥8.4 category (P=0.089). AAD/6W remained stable for roxadustat but increased for DA with decreasing baseline iron repletion markers. The relationship between roxadustat doses and end of treatment (EoT) hs-CRP was not significant (estimated slope, -0.494; P=0.814); a trend toward increased DA doses was observed with increasing EoT hs-CRP (estimated slope, 2.973; P=0.075). Roxadustat doses required to maintain target hemoglobin appear to be less affected by factors that underlie ESA hyporesponsiveness, relative to DA; roxadustat may be beneficial for patients hyporesponsive to ESAs. This article is protected by copyright. All rights reserved.",2020,AAD/6W remained stable for roxadustat but increased for DA with decreasing baseline iron repletion markers.,"['415 enrolled patients, 303 were randomized (roxadustat, n=151; DA, n=152', 'hemodialysis-dependent CKD patients treated with', 'Anemia Treatment in Hemodialysis Patients', 'anemia in chronic kidney disease (CKD', 'patients who inadequately respond to erythropoiesis stimulating agents (ESAs']","['traditional ESAs', 'Roxadustat Versus Darbepoetin Alfa']","['mean of average doses of roxadustat and DA per administration in the last 6\u2009weeks (AAD/6W) by prior ESA resistance index (ERI), iron repletion (transferrin saturation; ferritin), and high-sensitivity C-reactive protein (hs-CRP', 'DA doses']","[{'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1561828', 'cui_str': 'Anemia in chronic kidney disease'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",415.0,0.0350868,AAD/6W remained stable for roxadustat but increased for DA with decreasing baseline iron repletion markers.,"[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Showa University School of Medicine Namics 301, 4-24-51 Takanawa, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Data Science, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Majikawa', 'Affiliation': 'Japan-Asia Clinical Development 2, Development, Astellas Pharma, Inc, Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Development Medical Science, Astellas Pharma Europe B.V.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13609']
1968,33200551,Shooting shots: Estimating alcoholic drink sizes in real life using event-level reports and annotations of close-up pictures.,"INTRODUCTION AND AIMS


Drinks consumed in real life are diverse, in terms of beverage type, container size and alcohol by volume. To date, most ecological momentary assessment studies have assessed drinking amounts with 'standard' drinks, although their event-level design allows for more advanced assessment schemes. The purpose of this empirical study is to compare participants' estimates of alcoholic drink characteristics, assessed using drink-specific questions, with estimates generated by annotators based on pictures of the same drinks.
DESIGN AND METHODS


On weekend nights, 186 young adults took 1484 close-up pictures of their drinks using a custom-built smartphone application. Participants reported the beverage type, drink size and alcohol by volume. Annotators described the beverage type, container size and filling level. Correspondence between participants' and annotators' estimates was explored using descriptive statistics, difference tests and correlations.
RESULTS


Annotators were unable to precisely identify the beverage types in most pictures of liqueurs, spirits and mixed drinks. Participants' drink size estimates converged with annotators' estimates of the container size for beer (41 cl corresponding to 16 g of pure alcohol) and mixed drinks (28 cl/35 g), and of the content size for wine (10 cl/9 g). However, annotators estimated larger sizes for liqueur/fortified wine (12 cl/14 g vs. 7 cl/9 g) and spirits (8 cl/26 g vs. 4 cl/10 g) than participants.
DISCUSSION AND CONCLUSIONS


Annotations of pictures should be considered as a complement to participants' reports rather than a substitute. Except for wine, real-life drinks vary largely and often exceed 10 g 'standard' drinks.",2020,"Participants' drink size estimates converged with annotators' estimates of the container size for beer (41 cl corresponding to 16 g of pure alcohol) and mixed drinks (28 cl/35 g), and of the content size for wine (10 cl/9 g).",['186 young adults took 1484 close-up pictures of their drinks using a custom-built smartphone application'],[],"['beverage type, drink size and alcohol by volume']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],"[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",186.0,0.0568818,"Participants' drink size estimates converged with annotators' estimates of the container size for beer (41 cl corresponding to 16 g of pure alcohol) and mixed drinks (28 cl/35 g), and of the content size for wine (10 cl/9 g).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Labhart', 'Affiliation': 'Idiap Research Institute, Social Computing Group, Martigny, Switzerland.'}, {'ForeName': 'Thanh-Trung', 'Initials': 'TT', 'LastName': 'Phan', 'Affiliation': 'Idiap Research Institute, Social Computing Group, Martigny, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gatica-Perez', 'Affiliation': 'Idiap Research Institute, Social Computing Group, Martigny, Switzerland.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kuntsche', 'Affiliation': 'Centre for Alcohol Policy Research, La Trobe University, Melbourne, Australia.'}]",Drug and alcohol review,['10.1111/dar.13212']
1969,33200626,The Effect of Calcium Supplementation on Body Weight Before and During Pregnancy in Women Enrolled in the WHO Calcium and Preeclampsia Trial.,"INTRODUCTION


Obesity is a major and challenging public health problem. The aim of this substudy is to evaluate the effect of calcium supplementation on body weight in women recruited in the Calcium and Preeclampsia trial.
METHODS


Women were recruited before pregnancy and randomized to receive a calcium supplement containing 500 mg of elemental calcium or placebo until 20 weeks' gestation; all women received 1.5 g from 20 weeks until delivery.
RESULTS


A total of 630 women conceived during the study, 322 allocated to calcium and 308 to placebo. Among these, 230 allocated to calcium and 227 allocated to placebo had information on body weight at baseline and at 8 weeks' gestation. During the study period, women allocated to calcium had a mean weight increase of 1.1 (SD ±5.5) kg, whereas those allocated to placebo had a mean increase of 1.5 (SD ±6.1) kg, a mean difference of 0.4 kg (95% -0.4 (-1.4 to 0.6);  P  = .408). Women classified as obese at the start of the trial had a lower body weight gain at 8 weeks' gestation (1.0 kg; 95% CI: -3.2 to 1.2;  P  = .330) and at 32 weeks' gestation (2.1 kg; 95% CI: 5.6-1.3;  P  = .225) if they received calcium as compared to placebo. However, none of these differences were statistically significant.
CONCLUSION


The smaller increase in body weight found in women supplemented with 500 mg elemental calcium daily is quantitatively consistent with previous studies. However, in this study, the difference was not statistically significant.",2020,"However, none of these differences were statistically significant.
","['630 women conceived during the study, 322 allocated to calcium and 308 to', 'women recruited in the Calcium and Preeclampsia trial', 'Women were recruited before pregnancy', 'Women Enrolled in the WHO Calcium and Preeclampsia Trial']","['calcium supplementation', 'Calcium Supplementation', 'placebo', 'calcium supplement containing 500 mg of elemental calcium or placebo', 'calcium']","['Body Weight', 'mean weight increase', 'body weight', 'body weight gain']","[{'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",630.0,0.610781,"However, none of these differences were statistically significant.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Cormick', 'Affiliation': 'Department of Mother and Child Health Research, 172472Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Ana Pilar', 'Initials': 'AP', 'LastName': 'Betrán', 'Affiliation': 'HRP-UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, 3489World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Janetta', 'Initials': 'J', 'LastName': 'Harbron', 'Affiliation': 'Department of Human Biology, Faculty of Health Sciences, 37716University of Cape Town, South Africa.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': '217256Instituto Nacional de Higiene, Epidemiología y Microbiología, La Habana, Cuba.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'White', 'Affiliation': 'Departamento de Salud, 28224Universidad Nacional de La Matanza, San Justo, Argentina.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Roberts', 'Affiliation': 'Magee-Womens Research Institute, Department of Obstetrics and Gynecology, Epidemiology and Clinical and Translational Research 6614University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Belizán', 'Affiliation': 'Department of Mother and Child Health Research, 172472Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'G Justus', 'Initials': 'GJ', 'LastName': 'Hofmeyr', 'Affiliation': 'Effective Care Research Unit, 37707Universities of the Witwatersrand, Walter Sisulu and Fort Hare, South Africa.'}]",Food and nutrition bulletin,['10.1177/0379572120944671']
1970,33200660,Effects of scanning parameters reduction in dental radiographs on image quality and diagnostic performance: A randomised controlled trial.,"OBJECTIVES


To investigate the effect of reducing scanning parameters of digital dental panoramic tomogram (DPT) and lateral cephalometric (LC) radiographs on quality and diagnostic performance of the images.
DESIGN


Single-centre prospective two-arm parallel randomised controlled trial.
SETTING


Orthodontic Clinic, Faculty of Dentistry, Universiti Teknologi MARA, Selangor, Malaysia.
PARTICIPANTS


Adult orthodontic patients aged 18-35 years, indicated for DPT and LC, who were fit and healthy with a body mass index of 18.5-25.0, not contraindicated to radiographic examination, not pregnant, and did not have a history of facial or skeletal abnormalities or bone diseases were included.
METHODS


Thirty-eight adult orthodontic patients were randomised into control and intervention groups. DPT and LC radiographs in the control group were obtained using standard scanning parameters as prescribed by the manufacturer using Orthopantomograph® OP300 by Instrumentarium. Scanning parameters in the intervention group were reduced by 60% for DPT (60 kV, 3.2 mA) and 30% for LC (85 kV, 8 mA). A five-point rating scale was used for the assessment of image quality. Images were evaluated for diagnostic performance by detection of anatomical landmarks. Mann-Whitney test was performed to compare the quality and diagnostic performance of the images and the observer agreement was assessed using the intraclass correlation coefficient (ICC).
RESULTS


For image quality, the control group produced slightly lower median scores (DPT 2.0, LC 2.0) compared to the intervention group (DPT 2.0, LC 3.0). For diagnostic performance, both groups showed similar median scores (DPT 21.0, LC 32.0). The differences between control and intervention groups for both modalities were not statistically significant. The average scores for intra-observer agreement were excellent (ICC 0.917) and inter-observer agreement was good (ICC 0.822).
CONCLUSION


Minimising radiation exposure by reducing scanning parameters on digital DPT by 60% and LC by 30% on Intsrumentarium 300 OP did not affect the quality and diagnostic performance of the images. Thus, scanning parameters on digital DPT and LC should be reduced when taking radiographs.",2020,"RESULTS


For image quality, the control group produced slightly lower median scores (DPT 2.0, LC 2.0) compared to the intervention group (DPT 2.0, LC 3.0).","['Orthodontic Clinic, Faculty of Dentistry, Universiti Teknologi MARA, Selangor, Malaysia', 'Adult orthodontic patients aged 18-35 years, indicated for DPT and LC, who were fit and healthy with a body mass index of 18.5-25.0, not contraindicated to radiographic examination, not pregnant, and did not have a history of facial or skeletal abnormalities or bone diseases were included', 'Thirty-eight adult orthodontic patients']",['digital dental panoramic tomogram (DPT) and lateral cephalometric (LC) radiographs'],"['intraclass correlation coefficient (ICC', 'median scores', 'image quality and diagnostic performance', 'DPT and LC radiographs', 'quality and diagnostic performance']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0324975', 'cui_str': 'Dolichotis patagonum'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0442258', 'cui_str': 'Dental panoramic'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450361', 'cui_str': '38'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442258', 'cui_str': 'Dental panoramic'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442258', 'cui_str': 'Dental panoramic'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",38.0,0.0632392,"RESULTS


For image quality, the control group produced slightly lower median scores (DPT 2.0, LC 2.0) compared to the intervention group (DPT 2.0, LC 3.0).","[{'ForeName': 'Liyana', 'Initials': 'L', 'LastName': 'Ghazali', 'Affiliation': 'Centre for Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Mohd Yusmiaidil Putera', 'Initials': 'MYP', 'LastName': 'Mohd Yusof', 'Affiliation': 'Centre for Oral and Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Noraina Hafizan', 'Initials': 'NH', 'LastName': 'Norman', 'Affiliation': 'Centre for Paediatric Dentistry and Orthodontic Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh, Selangor, Malaysia.'}]",Journal of orthodontics,['10.1177/1465312520971641']
1971,33200722,"Multidrug Therapy for Leprosy Can Cure Patients with Lobomycosis in Acre State, Brazil: A Proof of Therapy Study.","Lobomycosis, also referred to as lacaziosis, is an endemic cutaneous and subcutaneous fungal disease that mainly affects Amazonian forest dwellers in Brazil. There is no disease control program in place in Brazil, and antifungal therapy failures are common, and the therapy is inaccessible to most patients. We performed a randomized, unblinded clinical trial testing the cure rate of multiple drug therapy (MDT) for leprosy with surgical excision, with or without itraconazole. A control arm consisted of patients who did not adhere to either therapeutic regimens but continued to be followed up. Multiple drug therapy consisted of monthly supervised doses of 600 mg rifampicin, 300 mg clofazimine, and 100 mg dapsone, in addition to daily doses of 50 mg clofazimine and 100 mg dapsone. The patients in the MDT plus itraconazole arm also received itraconazole 100 mg twice daily. We followed up 54 patients from the MDT group and 26 patients from the MDT plus itraconazole group for an average of 4 years and 9 months. The 23 controls were followed up for 6 months on average. The following endpoints were observed: 1) unchanged (no apparent improvement), 2) improved (reduction in lesion size and/or pruritus), and 3) cured (complete remission of the lesions, no viable fungi, and no relapse for 2 years after the end of the drug treatment). The results indicated a significantly greater likelihood of cure associated with the use of multidrug therapy for leprosy with or without itraconazole when compared with the control group. The addition of itraconazole to MDT was not associated with improved outcomes, suggesting that MDT alone is effective.",2020,"The addition of itraconazole to MDT was not associated with improved outcomes, suggesting that MDT alone is effective.",['54 patients from the MDT group and 26 patients from the'],"['itraconazole', 'clofazimine and 100 mg dapsone', 'Multidrug Therapy', 'MDT', 'multiple drug therapy (MDT', 'rifampicin, 300 mg clofazimine, and 100 mg dapsone', 'MDT plus itraconazole']","['likelihood of cure', 'lesion size and/or pruritus), and 3) cured (complete remission of the lesions, no viable fungi, and no relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0008996', 'cui_str': 'Clofazimine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3854359', 'cui_str': 'Multiple drug therapy'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.03203,"The addition of itraconazole to MDT was not associated with improved outcomes, suggesting that MDT alone is effective.","[{'ForeName': 'Franciely Gomes', 'Initials': 'FG', 'LastName': 'Gonçalves', 'Affiliation': 'Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil.'}, {'ForeName': 'Patrícia Sammarco', 'Initials': 'PS', 'LastName': 'Rosa', 'Affiliation': 'Divisão de Pesquisa e Ensino, Instituto Lauro de Souza Lima, Bauru, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'de Farias Fernandes Belone', 'Affiliation': 'Divisão de Pesquisa e Ensino, Instituto Lauro de Souza Lima, Bauru, Brazil.'}, {'ForeName': 'Léia Borges', 'Initials': 'LB', 'LastName': 'Carneiro', 'Affiliation': 'Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil.'}, {'ForeName': 'Vânia Lúcia', 'Initials': 'VL', 'LastName': 'Queiroz de Barros', 'Affiliation': 'Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil.'}, {'ForeName': 'Rosineide Ferreira', 'Initials': 'RF', 'LastName': 'Bispo', 'Affiliation': 'Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil.'}, {'ForeName': 'Yally', 'Initials': 'Y', 'LastName': 'Alves da Silva Sbardellott', 'Affiliation': 'Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil.'}, {'ForeName': 'Sebastião Afonso', 'Initials': 'SA', 'LastName': 'Viana Macedo Neves', 'Affiliation': 'Universidade Federal do Acre, Rio Branco, Brazil.'}, {'ForeName': 'Amy Y', 'Initials': 'AY', 'LastName': 'Vittor', 'Affiliation': 'Division of Infectious Diseases and Global Medicine, Department of Medicine, College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'William John', 'Initials': 'WJ', 'LastName': 'Woods', 'Affiliation': 'Serviço Estadual de Dermatologia do Acre, Programa Estadual de Dermatologia do Acre, Programa Estadual de Controle da Hanseníase (SESACRE), Rio Branco, Brazil.'}, {'ForeName': 'Gabriel Zorello', 'Initials': 'GZ', 'LastName': 'Laporta', 'Affiliation': 'Setor de Pós-graduação, Pesquisa e Inovação, Centro Universitário Saúde ABC, Fundação ABC, Santo André, Brazil.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0090']
1972,33200772,Comparative effects of telephone versus in-office behavioral counseling to improve HIV treatment outcomes among people living with HIV in a rural setting.,"With the expansion of telehealth services, there is a need for evidence-based treatment adherence interventions that can be delivered remotely to people living with HIV. Evidence-based behavioral health counseling can be delivered via telephone, as well as in-office services. However, there is limited research on counseling delivery formats and their differential outcomes. The purpose of this study was to conduct a head-to-head comparison of behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling delivered by in-office sessions to improve HIV treatment outcomes. Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider. The trial implemented a Wennberg Randomized Preferential Design to rigorously test: (a) patient preference and (b) comparative effects on patient retention in care and treatment adherence. There was a clear patient preference for telephone-delivered counseling (69%) over in-office-delivered counseling (31%) and participants who received telephone counseling completed a greater number of sessions. There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load. Overall improvements in health outcomes were not observed across delivery formats. Telephone-delivered counseling did show somewhat greater benefit for improving depression symptoms, whereas in-office services demonstrated greater benefits for reducing alcohol use. These results encourage offering most patients the choice of telephone and in-office behavioral health counseling and suggest that more intensive interventions may be needed to improve clinical outcomes for people living with HIV who may be at risk for discontinuing care or experiencing HIV treatment failure.",2020,"There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load.","['people living with HIV in a rural setting', 'Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider', 'people living with HIV who may be at risk for discontinuing care or experiencing HIV treatment failure']","['Telephone-delivered counseling', 'telephone versus in-office behavioral counseling', 'telephone counseling', 'behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling']","['health outcomes', 'depression symptoms', 'clinical appointment attendance, antiretroviral adherence, and HIV viral load', 'HIV treatment outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",251.0,0.0756517,"There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load.","[{'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Katner', 'Affiliation': 'Department of Medicine, Mercer University Medical School, Macon, GA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Eaton', 'Affiliation': 'Institute for Collaboration on Health Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Banas', 'Affiliation': 'Department of Medicine, Mercer University Medical School, Macon, GA, USA.'}, {'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Medicine, Mercer University Medical School, Macon, GA, USA.'}, {'ForeName': 'Moira O', 'Initials': 'MO', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}]",Translational behavioral medicine,['10.1093/tbm/ibaa109']
1973,33200782,Optimizing a Dual-Choice Cube Olfactometer Design for Measuring Adult Secondary Screwworm (Diptera: Calliphoridae) Attraction to a Resource.,"Detecting and locating a carrion resource is critical for the reproduction of necrophagous insects and initiating forensically important timelines. Blow flies (Diptera: Calliphoridae) primarily use olfactory cues in the form of volatile organic compounds to locate a suitable resource. Factors governing detecting and locating a resource have been studied using various behavior assays with modifications to suit the experiment design, such as the dual-choice cube olfactometer, which was examined in the current study. Systems optimization ensures biologically relevant and consistent results across replicates. In this study, two responses were measured: 1) leaving cube for either control or treatment and 2) choice between control and treatment. Phenotype (e.g., male, non-gravid, gravid) and total blow fly, Cochliomyia macellaria (Fabricius) (Diptera: Calliphoridae), number to respond were measured. Four parameters were assessed for their impact on response: 1) adjustment time in cube before trial, 2) trial length, 3) sugar/water presence, and 4) screening type in arms. Approximately, 70% of all phenotypes responded to liver with the 30-min adjustment period where only 50% responded with other adjustment periods. Trial length had a significant impact on response (35% increase in the 8 h trial compared to shorter durations); however, significant response to treatment was lost by increasing trial length. The presence of sugar/water decreased gravid and non-gravid response by 35% but did not impact males. Screening had no influence on overall or treatment response. Data indicate experiment design impacts fly response. Future studies should optimize parameters for their given fly population prior to initiating experiments.",2020,The presence of sugar/water decreased gravid and non-gravid response by 35% but did not impact males.,[],['Blow flies (Diptera: Calliphoridae'],"['response: 1) adjustment time in cube before trial, 2) trial length, 3) sugar/water presence, and 4) screening type', 'presence of sugar/water decreased gravid and non-gravid response', 'response', 'overall or treatment response']",[],"[{'cui': 'C0322495', 'cui_str': 'Blow fly'}, {'cui': 'C0012578', 'cui_str': 'Order Diptera'}]","[{'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",2.0,0.023998,The presence of sugar/water decreased gravid and non-gravid response by 35% but did not impact males.,"[{'ForeName': 'Casey A', 'Initials': 'CA', 'LastName': 'Flint', 'Affiliation': 'Department of Entomology, Texas A&M University, College Station, TX.'}, {'ForeName': 'Jeffery K', 'Initials': 'JK', 'LastName': 'Tomberlin', 'Affiliation': 'Department of Entomology, Texas A&M University, College Station, TX.'}]",Journal of medical entomology,['10.1093/jme/tjaa254']
1974,33200808,Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: A randomized controlled trial.,"BACKGROUND AND AIMS


Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early PEB, especially in patients with high risk of PEB.
METHODS


This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for PEB were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be >40 mm and those who were regularly taking antithrombotic agents were defined as high-risk patients. Patients were randomly assigned to the PHP or control group.
RESULTS


Between May 2017 and September 2018, 143 patients were enrolled (PHP group: 73, control group: 70). The total PEB rate was 6.3% (PHP group: 5% vs. control group: 7.1%, P=0.742). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor of PEB. In subgroup analysis excluding patients who continued to take antithrombotics (n=129) during ESD, the rate of PEB was tended to be lower in the PHP group than in the control group (0% vs. 6.3%, P=0.058).
CONCLUSION


PHP did not demonstrate a significant effect on the prevention of PEB in this study. Further larger-scale, randomized controlled trials are needed to confirm this.(ClinicalTrials.gov 03169569).",2020,"The total PEB rate was 6.3% (PHP group: 5% vs. control group: 7.1%, P=0.742).","['Patients with a high risk for PEB were enrolled', 'Patients with gastric neoplasms in whom the resected specimen size was expected to be >40 mm and those who were regularly taking antithrombotic agents were defined as high-risk patients', 'Between May 2017 and September 2018, 143 patients were enrolled (PHP group: 73, control group: 70', 'high risk patients', 'patients with high risk of PEB']","['Polysaccharide hemostatic powder', 'PHP or control group', 'polysaccharide hemostatic powder (PHP', 'endoscopic submucosal dissection (ESD']","['rate of PEB', 'total PEB rate', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0016018', 'cui_str': 'Thrombolytic agent'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",143.0,0.157457,"The total PEB rate was 6.3% (PHP group: 5% vs. control group: 7.1%, P=0.742).","[{'ForeName': 'Da Hyun', 'Initials': 'DH', 'LastName': 'Jung', 'Affiliation': 'Yonsei University College of Medicine, Internal Medicine, Seodaemun-gu, Korea (the Republic of).'}, {'ForeName': 'Chan Hyuk', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Hanyang University College of Medicine, Department of Internal Medicine, Guri, Korea (the Republic of).'}, {'ForeName': 'Hee Seok', 'Initials': 'HS', 'LastName': 'Moon', 'Affiliation': 'Chung Nam National University Hospital, Internal medicine, Dae Jeon, Korea (the Republic of).'}, {'ForeName': 'Jun Chul', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Yonsei University College of Medicine, Division of Gastroenterology, Department of Internal Medicine, Institute of Gastroenterology, Seoul, Korea (the Republic of).'}]",Endoscopy,['10.1055/a-1312-9420']
1975,33200812,"Low dose of ROSuvastatin in combination with EZEtimibe effectively and permanently reduce low density lipoprotein cholesterol concentration independently of timing of administration (ROSEZE): A randomized, crossover study - preliminary results.","BACKGROUND


In an attempt to improve low density lipoprotein-cholesterol (LDL-C) level control in patients ineffectively treated with statins, we evaluated the effectiveness of a fixed-dose combination (FDC) of 10 mg rosuvastatin and ezetimibe and its relation to the timing of drug administration.
METHODS


A randomized, open label, single center, crossover study involving 83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥ 70 mg/dL. In arm I the FDC drug was administered in the morning for 6 weeks, then in the evening for the following 6 weeks and vice versa in arm II. The primary endpoint was the change in LDL-C after 6 and 12 weeks.
RESULTS


The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL (Q1;Q3: 85.10;116.80), 63.14 mg/dL (50.70;77.10) and 59.40 mg/dL (49.00;73.30); p < 0.001. LDL-C levels were similar regardless of the timing of drug administration (morning 62.50 mg/dL [50.70;76.00] vs. evening 59.70 mg/dL [48.20;73.80]; p = 0.259], in both time points: 6 week: 63.15 mg/dL (50.75;80.65) vs. 63.40 mg/dL (50.60;74.00), p = 0.775; and 12 week: 62.00 mg/dL (50.20;74.40) vs. 59.05 mg/dL (47.65;66.05), p = 0.362. The absolute change in LDL-C concentration for the morning vs. evening drug administration was - 6 week: -34.6 mg/dL (-56.55; -19.85) (-34.87%) vs. -31.10 mg/dL (-44.20; -16.00) (-35.87%) (p not significant); 12. week: -34.20 mg/dL (-47.8; -19.0) (-37.12%) vs. -37.20 mg/dL (-65.55; -23.85) (-40.06%) (p not significant). The therapy was safe and well tolerated.
CONCLUSIONS


Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.",2020,"The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL","['patients ineffectively treated with statins', '83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥']","['dL', 'ROSuvastatin', 'rosuvastatin and ezetimibe']","['low density lipoprotein-cholesterol (LDL-C) level control', 'safe and well tolerated', 'LDL-C levels', 'low density lipoprotein cholesterol concentration', 'LDL-C concentration', 'median LDL-C concentration', 'change in LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",83.0,0.0791776,"The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Obońska', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland. k.obonska@cm.umk.pl.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kasprzak', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Tymosiak', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Fabiszak', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Krintus', 'Affiliation': 'Department of Laboratory Medicine, Nicolaus Copernicus University, Collegium Medicum, 9 Sklodowskiej-Curie Street, 85-094 Bydgoszcz, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Poland.'}]",Cardiology journal,['10.5603/CJ.a2020.0166']
1976,33200813,"Effects of trimetazidine in patients with severe chronic heart failure with reduced left ventricular ejection fraction: A prospective, randomized, open-label, cross-over study.","BACKGROUND


Trimetazidine (TMZ) modulates cardiac metabolism, but its use in heart failure remains controversial. The aim of the study was to evaluate the effects of TMZ on exercise capacity, left ventricular ejection fraction (LVEF), mortality, and quality of life in stable patients with heart failure with reduced left ventricular ejection fraction (HFrEF).
METHODS


Forty-five patients with stable advanced HFrEF treated with optimal medical therapy were randomized in a prospective, single-center, open-label, cross-over study of trimetazidine (35 mg b.i.d.) on top of standard medical therapy or standard pharmacotherapy for two periods of 30 days and one period of 6 months. Initially and at the end of each period all patients underwent the following: exercise testing, six-minute walk test (6MWT), two-dimensional-echocardiography, and quality of life assessment.
RESULTS


The mean age of patients was 58.2 ± 10.6 years. Etiology of HFrEF was ischemic in 66.6% of patients. After 6 months no significant changes were observed in either group with regards to peak VO₂ uptake, 6MWT, LVEF, or quality of life. TMZ had no effect on mortality or cardiovascular events.
CONCLUSIONS


The additional use of TMZ on top of standard medical therapy in stable advanced HFrEF patients was not associated with significant changes in mortality, exercise capacity, LVEF, or quality of life.",2020,"After 6 months no significant changes were observed in either group with regards to peak VO₂ uptake, 6MWT, LVEF, or quality of life.","['Forty-five patients with stable advanced HFrEF treated with optimal medical therapy', 'stable advanced HFrEF patients', 'The mean age of patients was 58.2 ± 10.6 years', 'patients with severe chronic heart failure with reduced left ventricular ejection fraction', 'stable patients with heart failure with reduced left ventricular ejection fraction (HFrEF']","['exercise testing, six-minute walk test (6MWT), two-dimensional-echocardiography, and quality of life assessment', 'TMZ', 'standard medical therapy or standard pharmacotherapy', 'Trimetazidine (TMZ', 'trimetazidine']","['mortality or cardiovascular events', 'peak VO₂ uptake, 6MWT, LVEF, or quality of life', 'mortality, exercise capacity, LVEF, or quality of life', 'exercise capacity, left ventricular ejection fraction (LVEF), mortality, and quality of life']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0013524', 'cui_str': 'Echocardiography, 2D'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",45.0,0.0274032,"After 6 months no significant changes were observed in either group with regards to peak VO₂ uptake, 6MWT, LVEF, or quality of life.","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Bohdan', 'Affiliation': 'First Department of Cardiology, Medical University of Gdansk, Poland. michal.bohdan@gumed.edu.pl.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Stopczyńska', 'Affiliation': 'First Department of Cardiology, Medical University of Gdansk, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Wiśniewski', 'Affiliation': 'Department of Endocrinology and Internal Diseases, Medical University of Gdansk, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moryś', 'Affiliation': 'Department of Clinical Psychology, Medical University of Gdansk, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Niedoszytko', 'Affiliation': 'Department of Rehabilitation Medicine, Medical University of Gdansk, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': 'First Department of Cardiology, Medical University of Gdansk, Poland.'}]",Cardiology journal,['10.5603/CJ.a2020.0165']
1977,33200844,"Bacillus Calmette-Guerin Polysaccharide Nucleic Acid versus Bacillus Calmette-Guerin vaccine in the Treatment of Warts: A comparative, double-blind, controlled study.","BACKGROUND


Bacillus Calmette-Guerin polysaccharide nucleic acid (BCG-PSN) is a relatively new generation, bacteria lipopolysaccharide fraction extracted from BCG vaccine. It has a strong immunomodulatory effect with higher efficacy and fewer side effects.
OBJECTIVE


To assess the clinical efficacy and safety of BCG-PSN versus the viable BCG vaccine in treatment of multiple warts.
PATIENTS AND METHODS


One hundred twenty patients with warts were allocated into 3groups each containing 40 patients. Each group received intralesionally 0.1ml of BCG-PSN, BCG vaccine, saline in group A, B and C respectively for a maximum of five sessions, 3 weeks apart.
RESULTS


Complete response occurred in 77.5% of group A versus 63.8% in group B. Partial response detected in 7.9% of control group(P<0.0001).The distant warts showed 72.5% complete clearance in group A compared to 58.3% in group B (P=0.19). Group A showed fewer number of sessions (P=0.03) and earlier response than group B (P=0.0003). A significant increase in the frequency of adverse effects was found among group B than group A (P<0.0001). No recurrence was seen in both groups.
CONCLUSION


BCG-PSN immunotherapy has a higher therapeutic efficacy with almost no serious side effects compared to the BCG vaccine in warts therapy. This article is protected by copyright. All rights reserved.",2020,A significant increase in the frequency of adverse effects was found among group B than group A (P<0.0001).,"['One hundred twenty patients with warts were allocated into 3groups each containing 40 patients', 'Warts']","['Bacillus Calmette-Guerin Polysaccharide Nucleic Acid versus Bacillus Calmette-Guerin vaccine', 'Bacillus Calmette-Guerin polysaccharide nucleic acid (BCG-PSN', 'BCG-PSN, BCG vaccine, saline', 'BCG vaccine', 'BCG-PSN', 'BCG-PSN immunotherapy']","['number of sessions', 'complete clearance', 'Partial response', 'frequency of adverse effects', 'Complete response']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",120.0,0.0852325,A significant increase in the frequency of adverse effects was found among group B than group A (P<0.0001).,"[{'ForeName': 'Howyda Mohamed', 'Initials': 'HM', 'LastName': 'Ebrahim', 'Affiliation': 'Faculty of Medicine, Zagazig University., Egypt.'}, {'ForeName': 'Ahmed Morad', 'Initials': 'AM', 'LastName': 'Asaad', 'Affiliation': 'Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University., Egypt.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Eldesoky', 'Affiliation': 'Dermatology, Faculty of Medicine, Zagazig University., Egypt.'}, {'ForeName': 'Hala Mohamed', 'Initials': 'HM', 'LastName': 'Morsi', 'Affiliation': 'Dermatology Department, Faculty of Medicine, Zagazig University, Egypt. Zagazig.'}]",Dermatologic therapy,['10.1111/dth.14549']
1978,33200887,"Phase I evaluation of the safety, tolerability, and pharmacokinetics of GSK3640254, a next-generation HIV-1 maturation inhibitor.","Despite advances in HIV-1 management with antiretroviral therapy, drug resistance and toxicities with multidrug regimens can result in treatment failure. Hence, there is a continuing demand for antiretroviral agents (ARVs) with novel mechanisms of action. Maturation inhibitors inhibit HIV-1 replication via a unique mechanism of action and can be combined with other ARVs. Two phase I randomized clinical trials were conducted for a maturation inhibitor, GSK3640254, to determine safety, pharmacokinetics (NCT03231943), and relative bioavailability (NCT03575962) in healthy adults. The first trial was conducted in two parts. Part 1 was conducted in a two-cohort, interlocking, eight-period fashion in 20 participants with single ascending doses of GSK3640254 (1-700 mg) or placebo. In Part 2, 58 participants were randomized to receive GSK3640254 (n = 44) or placebo (n = 14). Four participants reported adverse events (AEs) leading to study discontinuation, with one adverse drug reaction (maculopapular rash). There was no relationship between frequency or severity of AEs and dose. Pharmacokinetic assessments showed that GSK3640254 was slowly absorbed, with time to maximum concentration (tmax) occurring between 3.5 and 4 hours and half-life of ~24 hours. In the relative bioavailability study of GSK3640254 mesylate salt vs bis-hydrochloride salt capsules in 14 healthy adults, the mesylate salt performed slightly better than the bis-hydrochloride formulation (12%-16% increase in area under the concentration-time curve and maximum concentration); tmax (5 hours) was similar between the formulations. Initial pharmacokinetic and safety data from these healthy-participant studies informed further development of GSK3640254 for once-daily dosing for the treatment of HIV-1 infection.",2020,There was no relationship between frequency or severity of AEs and dose.,"['20 participants with single ascending doses of', '58 participants', 'healthy adults', '14 healthy adults']","['placebo', 'GSK3640254', 'GSK3640254 mesylate salt vs bis-hydrochloride salt capsules']","['adverse events (AEs) leading to study discontinuation, with one adverse drug reaction (maculopapular rash', 'area under the concentration-time curve and maximum concentration); tmax', 'safety, tolerability, and pharmacokinetics']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025619', 'cui_str': 'Mesilates'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0423791', 'cui_str': 'Maculopapular rash'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",20.0,0.113388,There was no relationship between frequency or severity of AEs and dose.,"[{'ForeName': 'Samit R', 'Initials': 'SR', 'LastName': 'Joshi', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Disala', 'Initials': 'D', 'LastName': 'Fernando', 'Affiliation': 'GlaxoSmithKline Clinical Unit Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Igwe', 'Affiliation': 'GlaxoSmithKline Clinical Unit Cambridge, Cambridge, UK.'}, {'ForeName': 'Litza', 'Initials': 'L', 'LastName': 'McKenzie', 'Affiliation': 'Quotient Sciences, Nottingham, UK.'}, {'ForeName': 'Anu S', 'Initials': 'AS', 'LastName': 'Krishnatry', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Halliday', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Zhan', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Greene', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Ferron-Brady', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lataillade', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",Pharmacology research & perspectives,['10.1002/prp2.671']
1979,33200890,Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis.,"BACKGROUND


Interleukin-1 has been implicated as a mediator of recurrent pericarditis. The efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β cytokine trap, were studied previously in a phase 2 trial involving patients with recurrent pericarditis.
METHODS


We conducted a phase 3, multicenter, double-blind, event-driven, randomized-withdrawal trial of rilonacept in patients with acute symptoms of recurrent pericarditis (as assessed on a patient-reported scale) and systemic inflammation (as shown by an elevated C-reactive protein [CRP] level). Patients presenting with pericarditis recurrence while receiving standard therapy were enrolled in a 12-week run-in period, during which rilonacept was initiated and background medications were discontinued. Patients who had a clinical response (i.e., met prespecified response criteria) were randomly assigned in a 1:1 ratio to receive continued rilonacept monotherapy or placebo, administered subcutaneously once weekly. The primary efficacy end point, assessed with a Cox proportional-hazards model, was the time to the first pericarditis recurrence. Safety was also assessed.
RESULTS


A total of 86 patients with pericarditis pain and an elevated CRP level were enrolled in the run-in period. During the run-in period, the median time to resolution or near-resolution of pain was 5 days, and the median time to normalization of the CRP level was 7 days. A total of 61 patients underwent randomization. During the randomized-withdrawal period, there were too few recurrence events in the rilonacept group to allow for the median time to the first adjudicated recurrence to be calculated; the median time to the first adjudicated recurrence in the placebo group was 8.6 weeks (95% confidence interval [CI], 4.0 to 11.7; hazard ratio in a Cox proportional-hazards model, 0.04; 95% CI, 0.01 to 0.18; P<0.001 by the log-rank test). During this period, 2 of 30 patients (7%) in the rilonacept group had a pericarditis recurrence, as compared with 23 of 31 patients (74%) in the placebo group. In the run-in period, 4 patients had adverse events leading to the discontinuation of rilonacept therapy. The most common adverse events with rilonacept were injection-site reactions and upper respiratory tract infections.
CONCLUSIONS


Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo. (Funded by Kiniksa Pharmaceuticals; RHAPSODY ClinicalTrials.gov number, NCT03737110.).",2020,"Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo.","['86 patients with pericarditis pain and an elevated CRP level were enrolled in the run-in period', 'patients with acute symptoms of recurrent pericarditis (as assessed on a patient-reported scale) and systemic inflammation (as shown by an elevated C-reactive protein [CRP] level', 'patients with recurrent pericarditis', 'Recurrent Pericarditis', '61 patients underwent randomization', 'Patients presenting with pericarditis recurrence while receiving', 'Patients who had a clinical response (i.e., met prespecified response criteria']","['rilonacept monotherapy or placebo', 'placebo', 'standard therapy', 'rilonacept', 'Interleukin-1 Trap Rilonacept']","['Safety', 'median time to resolution or near-resolution of pain', 'pericarditis recurrence', 'median time to normalization of the CRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C2343589', 'cui_str': 'rilonacept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",86.0,0.325434,"Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo.","[{'ForeName': 'Allan L', 'Initials': 'AL', 'LastName': 'Klein', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Imazio', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cremer', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Brucato', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Insalaco', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'LeWinter', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Sushil A', 'Initials': 'SA', 'LastName': 'Luis', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Pano', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Paolini', 'Affiliation': 'From the Center for the Diagnosis and Treatment of Pericardial Diseases, Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland (A.L.K., P.C.); University Cardiology, Cardiovascular, and Thoracic Department, Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino and University of Turin, Turin (M.I.), the Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan (A.B.), and the Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome (A.I.) - all in Italy; Pauley Heart Center, Virginia Commonwealth University, Richmond (A.A.); Kiniksa Pharmaceuticals, Lexington, MA (F.F., A.P., J.F.P); the Cardiology Unit, University of Vermont Medical Center, Burlington (M.L.); the Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel (B.S.L.); the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis (D.L.), and the Division of Cardiovascular Ultrasound, Department of Cardiovascular Medicine, Mayo Clinic, Rochester (S.A.L.) - both in Minnesota; the Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Clayton, VIC, Australia (S.J.N.); and Kiniksa Pharmaceuticals, Hamilton, Bermuda (A.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2027892']
1980,33192554,"Effect of High-Intensity Interval Training on Body Composition, Cardiorespiratory Fitness, Blood Pressure, and Substrate Utilization During Exercise Among Prehypertensive and Hypertensive Patients With Excessive Adiposity.","Regular exercise training is a recognized lifestyle strategy to lower resting blood pressure (BP), but little is known about substrate metabolism in population with high BP. Thus, the purpose of this study was to investigate the effects of 16-weeks of HIIT on body composition, BP, cardiorespiratory fitness by  V   .    O 2   max  , and substrate utilization during exercise among prehypertensive and hypertensive patients with excessive adiposity. We also aimed to test the potential association between changes in cardiorespiratory fitness, substrate utilization during exercise and BP. Forty-two physically inactive overweight/obese participants participated in 16-weeks of HIIT intervention. The HIIT frequency was three times a week (work ratio 1:2:10, for interval cycling: rest period: repeated times; 80-100% of the maximum heart rate). Groups were distributed based on their baseline BP: HIIT-hypertensive (H-HTN: age 47.7 ± 12.0 years; body mass index [BMI] 30.3 ± 5.5 kg/m 2 ; systolic [SBP]/diastolic BP [DBP] 151.6 ± 10/81.9 ± 4.2 mmHg), HIIT-pre-hypertensive (H-PreHTN: age 37.6 ± 12.0 years; BMI 31.9 ± 5.3 kg/m 2 ; SBP/DBP 134.4 ± 3.2/74.9 ± 7.0 mmHg), and a normotensive control group (H-CG: age 40.7 ± 11.0 years; BMI 29.5 ± 4.2 kg/m 2 ; SBP/DBP 117.0 ± 6.2/72.4 ± 4.1 mmHg). Anthropometry/body composition, BP, and metabolic substrate utilization during exercise (fat [FATox], carbohydrate [CHOox] oxidation, respiratory exchange ratio [RER], and  V   .    O 2   max ), were measured before and after the 16-week HIIT intervention. Adjusted mixed linear models revealed a significant improved in  V   .    O 2   max  were + 3.34 in the H-CG, + 3.63 in the H-PreHTN, and + 5.92 mL⋅kg -1 ⋅min -1 , in the H-HTN group, however, the Time × Group interaction were not significant ( p  = 0.083). All the exercise types induced similar decreases on SBP (-8.70) in the H-HTN, (-7.14) in the H-CG, and (-5.11) mmHg in the H-PreHTN, as well as DBP levels (-5.43) mmHg in H-CG group ( p  = 0.032 vs. H-HTN group). At 16-week, no significant correlations were noted for the changes of blood pressure, cardiorespiratory fitness or exercise metabolism substrates outcomes. In conclusion, our results suggest that a 16-week HIIT-intervention improved  V   .    O 2   max  and blood pressure BP, but these changes are independent of substrate utilization during exercise in normotensive and hypertensive participants with excessive adiposity.",2020,"At 16-week, no significant correlations were noted for the changes of blood pressure, cardiorespiratory fitness or exercise metabolism substrates outcomes.","['population with high BP', 'Prehypertensive and Hypertensive Patients With Excessive Adiposity', 'prehypertensive and hypertensive patients with excessive adiposity', 'Groups were distributed based on their baseline BP: HIIT-hypertensive (H-HTN: age 47.7 ± 12.0 years; body mass index [BMI] 30.3 ± 5.5 kg/m 2 ; systolic [SBP]/diastolic BP [DBP] 151.6 ± 10/81.9 ± 4.2 mmHg), HIIT-pre-hypertensive (H-PreHTN: age 37.6 ± 12.0 years; BMI 31.9 ± 5.3 kg/m 2 ; SBP/DBP 134.4 ± 3.2/74.9 ± 7.0 mmHg), and a normotensive control group (H-CG: age 40.7 ± 11.0 years; BMI 29.5 ± 4.2 kg/m 2 ; SBP/DBP 117.0 ± 6.2/72.4 ± 4.1 mmHg', 'normotensive and hypertensive participants with excessive adiposity', 'Forty-two physically inactive overweight/obese participants participated in 16-weeks of HIIT intervention']","['High-Intensity Interval Training', 'Exercise', 'Regular exercise training']","['Anthropometry/body composition, BP, and metabolic substrate utilization during exercise (fat [FATox], carbohydrate [CHOox] oxidation, respiratory exchange ratio [RER], and  V   ', 'SBP', 'Body Composition, Cardiorespiratory Fitness, Blood Pressure, and Substrate Utilization', 'DBP levels', 'O 2   max  , and substrate utilization', 'blood pressure, cardiorespiratory fitness or exercise metabolism substrates outcomes', 'body composition, BP, cardiorespiratory fitness by  V   ', 'O 2   max  and blood pressure BP', 'V   ', 'HIIT frequency']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",42.0,0.0142534,"At 16-week, no significant correlations were noted for the changes of blood pressure, cardiorespiratory fitness or exercise metabolism substrates outcomes.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Delgado-Floody', 'Affiliation': 'Department of Physical Education, Sport and Recreation, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Caamaño-Navarrete', 'Affiliation': 'Faculty of Education, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moris', 'Affiliation': 'Department of Physical Education, Sport and Recreation, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerez-Mayorga', 'Affiliation': 'Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago, Chile.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Andrade', 'Affiliation': 'Centro de Investigación en Fisiología del Ejercicio, Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Álvarez', 'Affiliation': 'Quality of Life and Wellness Research Group, Department of Physical Activity Sciences, Universidad de Los Lagos, Osorno, Chile.'}]",Frontiers in physiology,['10.3389/fphys.2020.558910']
1981,33192562,Wand Stretching Exercise Decreases Abdominal Obesity Among Adults With High Body Mass Index Without Altering Fat Oxidation.,"Rationale


We designed a wand-based muscle stretching (WE) exercise program, which has become increasingly popular in physical therapy and has been used for elderly patients with adhesive capsulitis. However, studies regarding the effects of WE training on abdominal obesity and measures of cardiovascular risk factors among overweight/obese adults aged ≥55 years are rare.
Purpose


The objective of this study is to evaluate the effects of a 15-week wand stretching exercise program on waist circumference and cardiovascular risk factors in sedentary adults aged 55-70 years.
Methods


A total of 124 participants were randomly assigned to either participate in wand stretching exercise (WE) over a 15-week period or a control group ( n  = 62 each). Sixty participants in the WE group (26 overweight and 34 obese) and 51 in the control group (29 overweight and 22 obese) completed the study. The WE program included wand-assisted muscle stretching exercise on both the upper body and lower body for 40 min per day, 5 days per week, whereas the control group maintained their sedentary lifestyle.
Results


No significant improvements were observed in plasma glucose, insulin, and the homeostatic model assessment of insulin resistance (HOMA-IR) after exercise training. Compared with the control group, the WE group had more significant reductions in waist circumference among participants with a body mass index (BMI) < 25 kg/m 2  (-2.6 cm, 95% CI: -4.19 to -0.97 cm,  d  = 0.48) and BMI > 25 kg/m 2  (-2.5 cm, 95% CI: -4.1 to -0.9 cm,  d  = 0.59) (both  P  < 0.01). Furthermore, within groups, a significant increase in % fat free mass was observed after WE training. The basal metabolic rate was slightly increased, but the fat oxidation rate remained unaltered in the WE group. Improvements in low-density lipoprotein cholesterol to high-density lipoprotein cholesterol were minimal after WE. Significant reductions in high-sensitivity C-reactive protein were observed after WE only for participants with a BMI <25 kg/m 2 .
Conclusion


The results suggest redistribution of a carbon source from the abdominal region to challenged skeletal muscle, following prolonged WE training. This abdominal fat reducing outcome of the WE is unlikely to be associated with fatty acid oxidation.",2020,"Significant reductions in high-sensitivity C-reactive protein were observed after WE only for participants with a BMI <25 kg/m 2 .
","['elderly patients with adhesive capsulitis', 'sedentary adults aged 55-70 years', 'Sixty participants in the WE group (26 overweight and 34 obese) and 51 in the control group (29 overweight and 22 obese) completed the study', 'Adults With High Body Mass Index', 'overweight/obese adults aged ≥55 years', '124 participants']","['wand-assisted muscle stretching exercise', 'control group maintained their sedentary lifestyle', 'Wand Stretching Exercise', '15-week wand stretching exercise program', 'wand-based muscle stretching (WE) exercise program', 'participate in wand stretching exercise (WE']","['plasma glucose, insulin, and the homeostatic model assessment of insulin resistance (HOMA-IR', 'waist circumference and cardiovascular risk factors', 'abdominal obesity and measures of cardiovascular risk factors', 'fat oxidation rate', 'waist circumference', 'basal metabolic rate', 'high-sensitivity C-reactive protein', 'low-density lipoprotein cholesterol to high-density lipoprotein cholesterol', ' fat free mass']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C1720868', 'cui_str': 'Muscle Stretching Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",124.0,0.0313138,"Significant reductions in high-sensitivity C-reactive protein were observed after WE only for participants with a BMI <25 kg/m 2 .
","[{'ForeName': 'Punnee', 'Initials': 'P', 'LastName': 'Puengsuwan', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Kuo', 'Affiliation': 'Laboratory of Exercise Biochemistry, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Rungchai', 'Initials': 'R', 'LastName': 'Chaunchaiyakul', 'Affiliation': 'College of Sports Science and Technology, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Ratanavadee', 'Initials': 'R', 'LastName': 'Nanagara', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Naruemon', 'Initials': 'N', 'LastName': 'Leelayuwat', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen, Thailand.'}]",Frontiers in physiology,['10.3389/fphys.2020.565573']
1982,33192669,Computer-Assisted Cognitive Remediation in Schizophrenia: Efficacy of an Individualized  vs . Generic Exercise Plan.,"Computer-assisted cognitive remediation (CACR) is an economical, adjustable, and effective treatment for individuals with schizophrenia. The current randomized controlled study examined whether an individualized or generic exercise plan in CACR is superior in patients with multiple cognitive deficits compared to treatment-as-usual (TAU). Fifty-nine inpatients diagnosed with schizophrenia were randomly assigned to 1) TAU, 2) TAU plus an individualized exercise plan in CACR, or 3) TAU plus a generic exercise plan in CACR. Neuropsychological performance, psychopathology, and functional outcome were assessed at baseline and post-treatment. The results show a medium to large training effect for all neuropsychological performance measures. Contrary to our expectations the neuropsychological improvement over time did not differ between groups. Self-reported depression, global level of functioning, and activity and participation functioning showed a significant improvement from baseline to post-treatment. However no further group, time, or interaction effects for other psychopathology and functional outcome could be demonstrated. Possible implications for clinical use of CACR and future studies are discussed.",2020,"Computer-assisted cognitive remediation (CACR) is an economical, adjustable, and effective treatment for individuals with schizophrenia.","['patients with multiple cognitive deficits compared to treatment-as-usual (TAU', 'Fifty-nine inpatients diagnosed with schizophrenia', 'individuals with schizophrenia']","['individualized or generic exercise plan', 'TAU', 'Computer-assisted cognitive remediation (CACR', 'Computer-Assisted Cognitive Remediation']","['Self-reported depression, global level of functioning, and activity and participation functioning', 'Neuropsychological performance, psychopathology, and functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",59.0,0.0274912,"Computer-assisted cognitive remediation (CACR) is an economical, adjustable, and effective treatment for individuals with schizophrenia.","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Bossert', 'Affiliation': 'Department of Clinical Psychology and Neuropsychology, SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Westermann', 'Affiliation': 'Department of Clinical Psychology and Neuropsychology, SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Schilling', 'Affiliation': 'Department of Clinical Psychology and Neuropsychology, SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weisbrod', 'Affiliation': 'Department of Psychiatry und Psychotherapy, SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Roesch-Ely', 'Affiliation': 'Centre for Psychosocial Medicine, Department of General Adult Psychiatry, Division Neurocognition, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Aschenbrenner', 'Affiliation': 'Department of Clinical Psychology and Neuropsychology, SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.555052']
1983,33192688,Types of Utilization and Types of Treatment Response in a Collaborative Care Approach for Depressive Disorders in Old Age in Primary Care.,"Background:  Treatment of depressive disorders in old age is hindered by several barriers. Most common are time pressure in primary care and latency for specialized therapeutic care. To improve treatment, the collaborative care approach GermanIMPACT was evaluated in a cluster-randomized controlled trial. Care managers offered a complex stepped-care intervention of monitoring, psychoeducation, and behavioral activation techniques. Twenty-six percent of the intervention group responds with a remission of depressive symptoms compared with 11% who received treatment as usual (TAU). The low-threshold intervention was more successful than TAU. Nevertheless, three-quarters did not respond with a remission. The aim of this study is to identify and describe the different types of utilization and of treatment response to understand what constitutes an effective intervention.  Methods:  Of 64 patients from the intervention group, we carried out problem-centered interviews with 26 patients from the intervention group. We analyzed the interviews using a qualitative type-building content analysis. For type construction, we performed a contrasting case comparison, regarding inductive and deductive categories of the intervention utilization and the symptom development.  Results:  The 26 participants' ages ranged from 62 to 87 years (mean = 72 years). Three participants were male. We identified five types of utilization, which differ primarily in the realization of pleasant activations, depending on own activity at the beginning and during the therapy: ""activatable relief seekers,"" ""active relief seekers,"" ""active relaxation seekers,"" ""passive problem-solving seekers,"" and ""passive relief seekers."" In the second typology, we analyzed four deductively determined types of treatment response  responders, slight improvers, constant moderates , and  non-responders . Patient-specific characteristics are a recent history of depression, an affinity for activities, supportive contacts, and limited comorbidity. In contrast, non-responders report contrary characteristics.  Conclusion:  Our two typologies emphasize that an effective intervention requires a match between intervention components and patient characteristics. We saw no intersections between utilization and treatment response. GermanIMPACT is an effective low-threshold intervention for moderately burdened patients, who are still capable of self-activation. An expansion of the intervention, especially for depression with a long history and comorbidities impairing mobility, could increase the effectiveness and improve the care situation of older people suffering from depression.",2020,"GermanIMPACT is an effective low-threshold intervention for moderately burdened patients, who are still capable of self-activation.","['Three participants were male', 'older people suffering from depression', 'Depressive Disorders in Old Age in Primary Care', '26 patients from the intervention group', ""26 participants' ages ranged from 62 to 87 years (mean = 72 years"", '64 patients from the intervention group', 'depressive disorders in old age']","['Collaborative Care Approach', 'GermanIMPACT']",['remission of depressive symptoms'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",3.0,0.0310519,"GermanIMPACT is an effective low-threshold intervention for moderately burdened patients, who are still capable of self-activation.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kloppe', 'Affiliation': 'Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Nadine Janis', 'Initials': 'NJ', 'LastName': 'Pohontsch', 'Affiliation': 'Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.565929']
1984,33192695,The Influence of the COVID-19 Outbreak on the Lifestyle of Older Patients With Dementia or Mild Cognitive Impairment Who Live Alone.,"Background:  Under the COVID-19 outbreak, the Japanese government has strongly encouraged individuals to stay at home. The aim of the current study was to clarify the effects of the COVID-19 outbreak on the lifestyle of older adults with dementia or mild cognitive impairment (MCI) who live alone.  Methods:  Seventy-four patients with dementia or MCI aged ≥65 years, who regularly visited the dementia clinic of the Department of Psychiatry, Osaka University Hospital, were recruited in this study. The patients were divided into two groups according to their living situation: living alone group ( n  = 12) and living together group ( n  = 62). Additionally, the spouses of patients aged ≥65 years were assigned to the healthy control group ( n  = 37). Subjects' lifestyle changes were evaluated between April 8 and 28, 2020.  Results:  No subjects with acquaintances or relatives were infected with COVID-19 within the study period. The proportion of subjects who reduced going out in the living alone group, living together group and healthy control group was 18.2, 52.5, and 78.4%, respectively. The proportion of subjects who went out less frequently was significantly lower in both the living alone ( p  < 0.01) and living together ( p  < 0.05) groups than in the healthy control group.  Conclusion:  Most patients with dementia or MCI who live alone did not limit their outings or activities during the COVID-19 outbreak. Regular monitoring for potential COVID-19 infection in people living alone with dementia is vital for their safety and well-being.",2020,The proportion of subjects who went out less frequently was significantly lower in both the living alone ( p  < 0.01) and living together ( p  < 0.05) groups than in the healthy control group.  ,"['people living alone with dementia', 'Older Patients With Dementia or Mild Cognitive Impairment', 'spouses of patients aged ≥65 years', ""Subjects' lifestyle changes were evaluated between April 8 and 28, 2020"", 'Methods:  Seventy-four patients with dementia or MCI aged ≥65 years, who regularly visited the dementia clinic of the Department of Psychiatry, Osaka University Hospital, were recruited in this study', 'older adults with dementia or mild cognitive impairment (MCI) who live alone']","['COVID-19 Outbreak', 'COVID-19 outbreak']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}]",[],74.0,0.0154888,The proportion of subjects who went out less frequently was significantly lower in both the living alone ( p  < 0.01) and living together ( p  < 0.05) groups than in the healthy control group.  ,"[{'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Behavioral Neurology and Neuropsychiatry, Osaka University United Graduate School of Child Development, Osaka, Japan.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Hotta', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Nagase', 'Affiliation': 'Department of Behavioral Neurology and Neuropsychiatry, Osaka University United Graduate School of Child Development, Osaka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Natsuho', 'Initials': 'N', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yuma', 'Initials': 'Y', 'LastName': 'Nagata', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Satake', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Suehiro', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kanemoto', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yoshiyama', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Mori', 'Affiliation': 'Department of Behavioral Neurology and Neuropsychiatry, Osaka University United Graduate School of Child Development, Osaka, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Psychiatry, Course of Integrated Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.570580']
1985,33192705,Tapering Antidepressants While Receiving Digital Preventive Cognitive Therapy During Pregnancy: An Experience Sampling Methodology Trial.,"Background:  Previous studies indicated that affect fluctuations, the use of antidepressant medication (ADM), as well as depression during pregnancy might have adverse effects on offspring outcomes. The aim of the current proof-of-principle study is to explore the effect of tapering ADM while receiving online preventive cognitive therapy (PCT) on pregnant women and the offspring as compared to pregnant women continuing ADM.  Objectives:  We sought to compare positive and negative affect fluctuations in pregnant women receiving online PCT while tapering ADM vs. pregnant women continuing ADM, and to investigate if affect fluctuations in early pregnancy were related to offspring birth weight.  Method:  An experience sampling methodology (ESM)-trial ran alongside a Dutch randomized controlled trial (RCT) and prospective observational cohort of women using ADM at the start of pregnancy. In the ESM-trial fluctuations of positive and negative affect were assessed in the first 8 weeks after inclusion. Recurrences of depression were assessed up to 12 weeks post-partum, and birth records were used to assess offspring birth weight. The RCT has been registered at the Netherlands Trial Register (NTR4694, https://www.trialregister.nl/trial/4551).  Results:  In total, 19 pregnant women using ADM at start of their pregnancy participated in the ESM-trial. There were no significant differences in positive and negative affect fluctuations, nor recurrence rates between women receiving PCT while tapering ADM vs. women continuing ADM. We found no association between affect fluctuations, pre-natal depressive symptoms, and birth weight (all  p  > 0.05).  Conclusion:  This explorative study showed that tapering ADM while receiving online PCT may protect pregnant women against recurrences of depression and affect fluctuations, without affecting birth weight. There is a high need for more controlled studies focusing on tapering ADM with (online) psychological interventions during pregnancy.",2020,"There were no significant differences in positive and negative affect fluctuations, nor recurrence rates between women receiving PCT while tapering ADM vs. women continuing ADM.","['women using ADM at the start of pregnancy', 'pregnant women receiving online PCT while tapering ADM vs. pregnant women continuing ADM', '19 pregnant women using ADM at start of their pregnancy participated in the ESM-trial', 'pregnant women and the offspring as compared to pregnant women continuing ADM']","['tapering ADM while receiving online PCT', 'tapering ADM while receiving online preventive cognitive therapy (PCT', 'Digital Preventive Cognitive Therapy', 'Tapering Antidepressants']","['positive and negative affect fluctuations, nor recurrence rates', 'Recurrences of depression', 'affect fluctuations, pre-natal depressive symptoms, and birth weight']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",19.0,0.131112,"There were no significant differences in positive and negative affect fluctuations, nor recurrence rates between women receiving PCT while tapering ADM vs. women continuing ADM.","[{'ForeName': 'Marlies E', 'Initials': 'ME', 'LastName': 'Brouwer', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Molenaar', 'Affiliation': 'Departments of Psychiatry and Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Centre Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Huibert', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centres, Location AMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Alishia D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': 'Faculty of Science, School of Psychology, The University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Casper J', 'Initials': 'CJ', 'LastName': 'Albers', 'Affiliation': 'Heymans Institute for Psychological Research, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Mijke P', 'Initials': 'MP', 'LastName': 'Lambregtse-van den Berg', 'Affiliation': 'Departments of Psychiatry and Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Centre Rotterdam, Rotterdam, Netherlands.'}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Centres, Location AMC, University of Amsterdam, Amsterdam, Netherlands.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.574357']
1986,33192706,Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients With Negative Symptoms.,"Background


We aimed to develop a Human Activity Recognition (HAR) model using a wrist-worn device to assess patient activity in relation to negative symptoms of schizophrenia.
Methods


Data were analyzed in a randomized, three-way cross-over, proof-of-mechanism study (ClinicalTrials.gov: NCT02824055) comparing two doses of RG7203 with placebo, given as adjunct to stable antipsychotic treatment in patients with chronic schizophrenia and moderate levels of negative symptoms. Baseline negative symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) and Brief Negative Symptom Scale (BNSS). Patients were given a GeneActiv ™  wrist-worn actigraphy device to wear over a 15-week period. For this analysis, actigraphy data and behavioral and clinical assessments obtained during placebo treatment were used. Motivated behavior was evaluated with a computerized effort-choice task. A trained HAR model was used to classify activity and an activity-time ratio was derived. Gesture events and features were inferred from the HAR-detected activities and the acceleration signal.
Results


Thirty-three patients were enrolled: mean (±SD) age 36.6 ± 7 years; mean (±SD) baseline PANSS negative symptom factor score 23.0 ± 3.5; and mean (±SD) baseline BNSS total score 36.0 ± 11.5. Activity data were collected for 31 patients with a median monitoring time of 1,859 h per patient, equating to ~11 weeks or 74% monitoring ratio. The trained HAR model demonstrated >95% accuracy in separating ambulatory and stationary activities. A positive correlation was seen between the activity-time ratio and the percent of high-effort choices (Spearman r = 0.58;  P  = 0.002) in the effort-choice task. Median daily gesture counts correlated negatively with the BNSS total score (Spearman r = -0.44;  P  = 0.03), specifically with the diminished expression sub-score (Spearman r = -0.42;  P  = 0.03). Gesture features also correlated negatively with the BNSS total score and diminished expression sub-scores. Activity measures showed similar correlations with PANSS negative symptom factor but did not reach significance.
Conclusion


Our findings support the use of wrist-worn devices to derive activity and gesture-based digital outcome measures for patients with schizophrenia with negative symptoms in a clinical trial setting.",2020,"Median daily gesture counts correlated negatively with the BNSS total score (Spearman r = -0.44;  P  = 0.03), specifically with the diminished expression sub-score (Spearman r = -0.42;  P  = 0.03).","['Thirty-three patients were enrolled: mean (±SD) age 36.6 ± 7 years; mean (±SD) baseline PANSS negative symptom factor score 23.0 ± 3.5; and mean (±SD) baseline BNSS total score 36.0 ± 11.5', '31 patients with a median monitoring time of 1,859 h per patient, equating to ~11 weeks or 74% monitoring ratio', 'patients with chronic schizophrenia and moderate levels of negative symptoms', 'Schizophrenia Patients With Negative Symptoms', 'patients with schizophrenia with negative symptoms in a clinical trial setting']","['GeneActiv ™  wrist-worn actigraphy device to wear over a 15-week period', 'RG7203 with placebo', 'Deep Learning-Based Human Activity Recognition']","['Motivated behavior', 'BNSS total score and diminished expression sub-scores', 'classify activity and an activity-time ratio', 'Median daily gesture counts', 'activity-time ratio', 'expression sub-score', 'Positive and Negative Syndrome Scale (PANSS) and Brief Negative Symptom Scale (BNSS', 'BNSS total score', 'Activity data']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020115', 'cui_str': 'Human Activities'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}]",31.0,0.0599133,"Median daily gesture counts correlated negatively with the BNSS total score (Spearman r = -0.44;  P  = 0.03), specifically with the diminished expression sub-score (Spearman r = -0.42;  P  = 0.03).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Umbricht', 'Affiliation': 'Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Wei-Yi', 'Initials': 'WY', 'LastName': 'Cheng', 'Affiliation': 'Roche Innovation Center New York, Roche TCRC Inc, NY, United States.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lipsmeier', 'Affiliation': 'Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Bamdadian', 'Affiliation': 'Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lindemann', 'Affiliation': 'Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.574375']
1987,33192710,"MindHike, a Digital Coaching Application to Promote Self-Control: Rationale, Content, and Study Protocol.","This protocol describes a study that will test the effectiveness of a 7-week non-clinical digital coaching intervention to promote self-control. The goal of the coaching is to support and guide people who are willing and motivated to improve their self-control with the help of the smartphone application MindHike. The coaching is based on a process model of self-control and aims to target five groups of self-control strategies. The goal of the study is to examine the effectiveness of the digital coaching intervention. A single-arm study design with pre-test, post-test and 2-month follow-up assessments and process assessments will be used to evaluate the 7-week digital coaching intervention. The digital coaching includes 49 daily lessons that are organized along 7 weekly core themes. Study participants will be at least 150 adults aged 18 years and older who are willing and motivated to improve their self-control using the MindHike application. This is the first study testing the effectiveness of a digital coaching intervention to promote self-control. Given that this approach proves effective, it could be easily implemented in various non-clinical settings such as education, health, relationship, and work, and in clinical settings. Due to its digital low-threshold character, it could also reach large numbers of people.",2020,The coaching is based on a process model of self-control and aims to target five groups of self-control strategies.,['Study participants will be at least 150 adults aged 18 years and older who are willing and motivated to improve their self-control using the MindHike application'],"['digital coaching intervention', '7-week non-clinical digital coaching intervention']",[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",[],150.0,0.0151279,The coaching is based on a process model of self-control and aims to target five groups of self-control strategies.,"[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Allemand', 'Affiliation': 'Department of Psychology and University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Keller', 'Affiliation': 'Department of Psychology and University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gmür', 'Affiliation': 'Department of Psychology and University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Gehriger', 'Affiliation': 'Department of Psychology and University Research Priority Program Dynamics of Healthy Aging, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Timon', 'Initials': 'T', 'LastName': 'Oberholzer', 'Affiliation': 'Wia Ventures GmbH, Gränichen, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'Department of Psychology, Brandeis University, Waltham, MA, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.575101']
1988,33192712,Associations Between Difficulties in Emotion Regulation and Post-Traumatic Stress Disorder in Deployed Service Members of the German Armed Forces.,"Background


Experiencing a traumatic event can lead to post-traumatic stress disorder (PTSD), but not every traumatized person develops PTSD. Several protective and risk factors have been identified in civilians and veterans to explain why some individuals develop PTSD and others do not. However, no research has confirmed the relationship between emotion regulation and PTSD in deployed German Armed Forces service members after a foreign assignment. Previous studies have identified some protective factors, such as social support, social acknowledgment, specific personal values, and posttraumatic growth, as well as risk factors, like moral injury and emotion regulation. Thus, the aim of the present study is to confirm the relationship between emotion regulation and PTSD and to test for factors that are associated with higher severity of PTSD symptoms in such a sample.
Methods


A  post-hoc  secondary analysis was conducted on data collected in a randomized controlled trial. Participants ( N  = 72) were male active and former military service members that have returned from deployment and were recruited from the German Armed Forces. These participants were separated into two groups according to PTSD diagnosis based on the results of a structured diagnostic interview. Data from evaluation questionnaires administered upon entry into the study were subjected to a cross-sectional analysis. The measures included the severity of PTSD symptoms, clusters of PTSD symptoms, clinical measures, and several measures assessing PTSD-related constructs. Analyses included the Spearman rank correlation coefficient, X 2  tests for nominal data, Mann-Whitney U-tests for non-parametric data, and a mediation analysis.
Results


The results of the mediation analysis revealed that difficulties in emotion regulation were significantly associated with the severity of PTSD symptoms, which was mediated by social acknowledgment and experimental avoidance but not by moral injury. The analyses showed that the severity of PTSD symptoms and all clusters of PTSD symptoms were significantly associated with most of the measured constructs in expectable directions. Participants in the PTSD group showed significantly higher mean scores on questionnaires measuring constructs that have been associated with PTSD, like emotion regulation and moral injury. They also showed lower mean scores in questionnaires for social support and social acknowledgment as a victim or survivor than participants in the non-PTSD group.
Conclusion


The present results show that difficulties in emotion regulation are directly associated with the severity of PTSD symptoms in service members of the German Armed Forces. This association is mediated by social acknowledgment and experimental avoidance, but not by moral injury. Thus, future studies should investigate these potentially crucial factors for better understanding of the development and maintenance of PTSD in service members of the German Armed Forces after deployment to create possible treatment adaptions.
Clinical Trial Registration


Australian Clinical Trials Registry, identifier ACTRN 12616000956404 http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370924.",2020,"Participants in the PTSD group showed significantly higher mean scores on questionnaires measuring constructs that have been associated with PTSD, like emotion regulation and moral injury.",['Participants ( N  = 72) were male active and former military service members that have returned from deployment and were recruited from the German Armed Forces'],[],"['Spearman rank correlation coefficient, X 2  tests for nominal data, Mann-Whitney U-tests', 'difficulties in emotion regulation', 'severity of PTSD symptoms and all clusters of PTSD symptoms', 'severity of PTSD symptoms, clusters of PTSD symptoms, clinical measures, and several measures assessing PTSD-related constructs', 'PTSD, like emotion regulation and moral injury']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]",[],"[{'cui': 'C0242929', 'cui_str': 'Spearman Rank Correlation Coefficient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C4505439', 'cui_str': 'Moral Injury'}]",72.0,0.0163551,"Participants in the PTSD group showed significantly higher mean scores on questionnaires measuring constructs that have been associated with PTSD, like emotion regulation and moral injury.","[{'ForeName': 'Jan Peter', 'Initials': 'JP', 'LastName': 'Spies', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Human Sciences, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jan Christopher', 'Initials': 'JC', 'LastName': 'Cwik', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Faculty of Human Sciences, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Gert Dieter', 'Initials': 'GD', 'LastName': 'Willmund', 'Affiliation': 'Department for Military Mental Health, German Armed Forces Military Hospital Berlin, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Knaevelsrud', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Niemeyer', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Sinha', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Küster', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Muschalla', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Technische Universität Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Köhler', 'Affiliation': 'Department for Military Mental Health, German Armed Forces Military Hospital Berlin, Berlin, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Division of Clinical Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Rau', 'Affiliation': 'Department for Military Mental Health, German Armed Forces Military Hospital Berlin, Berlin, Germany.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.576553']
1989,33192723,"The Effect of Cognitive Behavioral Therapy on Depression, Anxiety, and Stress in Patients With COVID-19: A Randomized Controlled Trial.","Background:  As a public health emergency of international concern, the COVID-19 outbreak has had a tremendous impact on patients' psychological health. However, studies on psychological interventions in patients with COVID-19 are relatively rare.  Objectives:  This study examined the effectiveness of Cognitive Behavioral Therapy (CBT) in relieving patients' psychological distress during the COVID-19 epidemic.  Methods:  Ninety-three eligible participants selected by cluster sampling were randomized to an intervention group ( N  = 47) and a control group ( N  = 46). Participants in the control group received routine treatment according to the Chinese Management Guidelines for COVID-19, while participants in the intervention group received routine treatment with additional CBT. The Chinese Version of Depression Anxiety and Stress Scale-21 (DASS-21) was used to evaluate depression, anxiety, and stress for all participants at baseline and post-intervention. Two-sided  t- test, and proportion tests were used to examine the differences between the intervention and control group for each DASS-21 indicator. Univariate linear regression was used to examine the association between chronic disease status and change in each DASS-21 indicator after intervention. Two-way scatter plots were generated to show the association of the length of hospital stay and the changes of each DASS-21 indicator by intervention and control groups.  Results:  Significant decreases in means were found for scales of depression, anxiety, stress and total DASS-21 in both intervention ( p  < 0.001) and control group ( p  = 0.001), with participants in the intervention group having a bigger reduction in means. After the intervention, more participants in the intervention group had no depression or anxiety symptoms than in the control group, but no statistical differences were found ( p  > 0.05). Compared with participants with chronic disease, participants with no chronic disease had a significantly larger reduction of total DASS-21 scale (coefficient = -4.74, 95% CI: -9.31; -0.17).The length of hospital stay was significantly associated with a greater increase in anxiety scale in the intervention group ( p  = 0.005), whilst no significant association was found in the control group ( p  = 0.29).  Conclusions:  The patients with COVID-19 experienced high levels of anxiety, depression and stress. Our study result highlights the effectiveness of CBT in improving the psychological health among patients with COVID-19, also suggests that CBT should be focused on patients with chronic disease and those who have longer hospital stays. These results have important implications in clinical practice in improving psychological health in the context of COVID-19 pandemic.  Trial Registration:  ISRCTN68675756. Available at: http://www.isrctn.com/ISRCTN68675756.",2020,"Significant decreases in means were found for scales of depression, anxiety, stress and total DASS-21 in both intervention ( p  < 0.001) and control group ( p  = 0.001), with participants in the intervention group having a bigger reduction in means.","['patients with COVID-19', 'Methods:  Ninety-three eligible participants selected by cluster sampling', 'patients with COVID-19 are relatively rare', ""patients' psychological distress during the COVID-19 epidemic"", 'Patients With COVID-19', 'patients with chronic disease and those who have longer hospital stays']","['Cognitive Behavioral Therapy (CBT', 'Cognitive Behavioral Therapy', 'routine treatment according to the Chinese Management Guidelines for COVID-19, while participants in the intervention group received routine treatment with additional CBT', 'CBT']","['depression, anxiety, and stress', 'hospital stay', 'anxiety scale', 'scales of depression, anxiety, stress and total DASS-21', 'levels of anxiety, depression and stress', 'Depression, Anxiety, and Stress', 'total DASS-21 scale', 'no depression or anxiety symptoms', 'length of hospital stay', 'Chinese Version of Depression Anxiety and Stress Scale-21 (DASS-21']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}]",93.0,0.0407745,"Significant decreases in means were found for scales of depression, anxiety, stress and total DASS-21 in both intervention ( p  < 0.001) and control group ( p  = 0.001), with participants in the intervention group having a bigger reduction in means.","[{'ForeName': 'Jinzhi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Xiuchuan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Stomatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Xuexue', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Stomatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Respiratory, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Intensive Care Unit, The Third People's Hospital of Bengbu, Bengbu, China.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': 'School of Population Health, University of New South Wales, Kensington, NSW, Australia.'}, {'ForeName': 'Huashan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Stomatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'School of Population Health, University of New South Wales, Kensington, NSW, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.580827']
1990,33192906,How Interpersonal Justice Shapes Legitimacy Perceptions: The Role of Interpersonal Justice Trajectories and Current Experience.,"Despite a growing body of research on the relationship between justice and perceptions of an authority's legitimacy, few studies have addressed the effects of changes in justice on perceived legitimacy. In the present study, we tested a dynamic model emphasizing the interactive influences of both interpersonal justice trajectories and current experience predicting perceived legitimacy. We tested the trajectory of interpersonal justice over time as a predictor of perceived legitimacy (Study 1) and the current experience of justice as a moderator of this link (Study 2). In Study 1 participants were randomly assigned to receive either improving or declining feedback from an anonymous tutor over the course of four days. Results showed that participants with an improving trajectory perceived the authority to have higher legitimacy. In Study 2 participants rated the tutor's fairness on 3 consecutive weeks, which were used to identify naturally interpersonal trajectories; we then manipulated the current interpersonal justice experience in the fourth week. Results showed that the trajectory effect was significant when the current experience was just, but not when it was unjust.",2020,"In Study 2 participants rated the tutor's fairness on 3 consecutive weeks, which were used to identify naturally interpersonal trajectories; we then manipulated the current interpersonal justice experience in the fourth week.",[],[],[],[],[],[],1.0,0.0216027,"In Study 2 participants rated the tutor's fairness on 3 consecutive weeks, which were used to identify naturally interpersonal trajectories; we then manipulated the current interpersonal justice experience in the fourth week.","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Psychology, Hubei University, Wuhan, China.'}, {'ForeName': 'Bibo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Psychology, Hubei University, Wuhan, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.582327']
1991,33192915,Promotion of Street-Dance Training on the Executive Function in Preschool Children.,"Executive function is the center of cognitive function, emotional function, and social function, and plays an important role in children's cognitive development. Previous studies used music, sports, and other training methods to promote the development of children's executive function. but researchers are still exploring more comprehensive and effective training methods. Street-dance, as a comprehensive dance form integrating the characteristics of movement, music, rhythm, and so on, needs the coordination of individual sensory systems and a sense of musical rhythm and action. These are the same activity elements found in previous studies that can improve the individual executive function of children. In order to investigate the promoting effect of street-dance training on children's executive function, this study designed a street-dance training program integrating the characteristics of each component of executive function. Sixty preschool children around the age of four ( M  = 52.4,  SD  = 3.95) participated using the pretest-posttest experimental design. The dancing group conducted street-dance training 3 times a week, 40-50 min each time for a total of 24 times; the control group did not train. We discovered that 8 weeks of street-dance training can promote the development of executive function in preschool children, and we discussed about the potential mechanism of the street dance training effects and the implications of intervention programs.",2020,"We discovered that 8 weeks of street-dance training can promote the development of executive function in preschool children, and we discussed about the potential mechanism of the street dance training effects and the implications of intervention programs.","[""children's executive function"", 'Sixty preschool children around the age of four ( M  = 52.4,  SD  = 3.95) participated using the pretest-posttest experimental design', 'Preschool Children', 'preschool children', ""children's cognitive development""]","['control group did not train', 'street-dance training', 'Street-Dance Training']",['Executive Function'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}]",60.0,0.0150137,"We discovered that 8 weeks of street-dance training can promote the development of executive function in preschool children, and we discussed about the potential mechanism of the street dance training effects and the implications of intervention programs.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'The Forth Kindergarten of Shahekou, Dalian, China.'}, {'ForeName': 'Lele', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Liaoning Normal University, Dalian, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.585598']
1992,33192928,Effects of Coloring Food Images on the Propensity to Eat: A Placebo Approach With Color Suggestions.,"Background


Research findings on the appetite-enhancing effect of the color red and the appetite-reducing effect of blue have been inconsistent. The present study used a placebo approach and investigated whether verbal suggestions can enhance color-appetite effects.
Method


A total of 448 women participated in two experiments. They viewed images with differently colored sweet foods (original color, blue, red, colorless (black-and-white); experiment 1;  n  = 217) or sweet foods on blue, red, white, and gray backgrounds; experiment 2;  n  = 231). Before viewing the images, half of the participants received information about the effects of red and blue food color on appetite (color suggestion). The other half received no suggestion. For each of the experiments, the reported propensity to eat (food wanting) was compared between the conditions.
Results


All colored food items were associated with a lower propensity to eat compared to the food items in the original color. The color suggestion (compared to no suggestion) additionally decreased the propensity to eat blue and black-and-white food items. Colored backgrounds did not influence food wanting.
Conclusion


This study demonstrated that red and blue coloring of visual food cues did not have the predicted effects on food wanting. However, the combination of specific food colors with specific color suggestions might be useful to change the willingness to eat sweet products.",2020,The color suggestion (compared to no suggestion) additionally decreased the propensity to eat blue and black-and-white food items.,['448 women participated in two experiments'],['Coloring Food Images'],['propensity to eat blue and black-and-white food items'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0016461', 'cui_str': 'Food coloring'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",448.0,0.0218383,The color suggestion (compared to no suggestion) additionally decreased the propensity to eat blue and black-and-white food items.,"[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Schlintl', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schienle', 'Affiliation': 'Department of Clinical Psychology, University of Graz, Graz, Austria.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.589826']
1993,33192940,"Promoting Middle School Students' Science Text Comprehension via Two Self-Generated ""Linking"" Questioning Methods.","This quasi-experimental study examined training in two types of reading strategies: self-generated questions either connecting to prior knowledge (Extra-Text) or connecting between the text's parts (Within-Text). Immediate and long-term effects were assessed on ninth graders' science text comprehension, versus an untrained control group. The three student groups ( N  = 193) received the same study unit of scientific texts and accompanying tasks, either with/without training in self-generated questioning. PISA-based science literacy assessments (phenomenon identification, scientific explanation, and evidence utilization) were collected at baseline, immediately after intervention, and at 4-month follow-up. Results from both short- and long-term assessments indicated that those learners trained to generate questions about within-text connections reached significantly higher science text comprehension achievements than the other two groups - students trained to generate questions connecting to their prior knowledge and control students who received no support for generating questions. Findings may contribute to the design of support methods and teaching strategies for promoting literacy in general and scientific literacy in particular.",2020,This quasi-experimental study examined training in two types of reading strategies: self-generated questions either connecting to prior knowledge (Extra-Text) or connecting between the text's parts (Within-Text).,[],"['scientific texts and accompanying tasks, either with/without training in self-generated questioning']",['science text comprehension achievements'],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",,0.013095,This quasi-experimental study examined training in two types of reading strategies: self-generated questions either connecting to prior knowledge (Extra-Text) or connecting between the text's parts (Within-Text).,"[{'ForeName': 'Hava', 'Initials': 'H', 'LastName': 'Sason', 'Affiliation': 'Herzog College, Alon Shvut, Israel.'}, {'ForeName': 'Tova', 'Initials': 'T', 'LastName': 'Michalsky', 'Affiliation': 'Bar-Ilan University, Ramat Gan, Israel.'}, {'ForeName': 'Zemira', 'Initials': 'Z', 'LastName': 'Mevarech', 'Affiliation': 'Bar-Ilan University, Ramat Gan, Israel.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.595745']
1994,33192959,Evaluation of an Immunomodulatory Probiotic Intervention for Veterans With Co-occurring Mild Traumatic Brain Injury and Posttraumatic Stress Disorder: A Pilot Study.,"Background:  US military Veterans returned from Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) with symptoms associated with mild traumatic brain injury [mTBI; i.e., persistent post-concussive (PPC) symptoms] and posttraumatic stress disorder (PTSD). Interventions aimed at addressing symptoms associated with both physical and psychological stressors (e.g., PPC and PTSD symptoms) are needed. This study was conducted to assess the feasibility, acceptability, and safety of a probiotic intervention, as well as to begin the process of evaluating potential biological outcomes.  Methods:  A pilot randomized controlled trial was implemented among US military Veterans from recent conflicts in Iraq and Afghanistan. Those enrolled had clinically significant PPC and PTSD symptoms. Participants were randomized to intervention ( Lactobacillus reuteri  DSM 17938) or placebo supplementation (daily for 8 weeks +/- 2 weeks) at a 1:1 ratio, stratified by irritable bowel syndrome status. Thirty-one Veterans were enrolled and randomized (15 to the placebo condition and 16 to the probiotic condition).  Results:  Thresholds for feasibility, acceptability, and safety were met. Probiotic supplementation resulted in a decrease in plasma C-reactive protein (CRP) concentrations relative to the placebo group that approached statistical significance ( p  = 0.056). Although during the Trier Social Stress Test (TSST; administered post-supplementation) no between-group differences were found on a subjective measure of stress responsivity (Visual Analog Scale), there was a significantly larger increase in mean heart beats per minute between baseline and the math task for the placebo group as compared with the probiotic group (estimated mean change, probiotic 5.3 [95% Confidence Interval: -0.55, 11.0], placebo 16.9 [11.0, 22.7],  p  = 0.006).  Conclusions:  Findings from this trial support the feasibility, acceptability, and safety of supplementation with an anti-inflammatory/immunoregulatory probiotic,  L. reuteri  DSM 17938, among Veterans with PPC and PTSD symptoms. Moreover, results suggest that CRP may be a viable inflammatory marker of interest. A larger randomized controlled trial aimed at measuring both biological and clinical outcomes is indicated.  Clinical Trial Registration:  ClinicalTrials.gov, Identifier NCT02723344.",2020,Probiotic supplementation resulted in a decrease in plasma C-reactive protein (CRP) concentrations relative to the placebo group that approached statistical significance ( p  = 0.056).,"['military Veterans returned from Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) with symptoms associated with mild traumatic brain injury [mTBI; i.e., persistent post-concussive (PPC) symptoms] and posttraumatic stress disorder (PTSD', 'Veterans With Co-occurring Mild Traumatic Brain Injury and Posttraumatic Stress Disorder', 'US military Veterans from recent conflicts in Iraq and Afghanistan', 'Thirty-one Veterans were enrolled and randomized (15 to the placebo condition and 16 to the probiotic condition', 'Veterans with PPC and PTSD symptoms']","['CRP', 'probiotic intervention', 'Probiotic supplementation', 'placebo', 'Immunomodulatory Probiotic Intervention', 'intervention ( Lactobacillus reuteri  DSM 17938) or placebo supplementation']","['plasma C-reactive protein (CRP) concentrations', 'subjective measure of stress responsivity (Visual Analog Scale', 'feasibility, acceptability, and safety', 'mean heart beats per minute']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C2350585', 'cui_str': 'Operation Enduring Freedom'}, {'cui': 'C4045979', 'cui_str': 'Operation Iraqi Freedom'}, {'cui': 'C4045978', 'cui_str': 'Operation New Dawn'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}]",31.0,0.114325,Probiotic supplementation resulted in a decrease in plasma C-reactive protein (CRP) concentrations relative to the placebo group that approached statistical significance ( p  = 0.056).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Brenner', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Jeri E', 'Initials': 'JE', 'LastName': 'Forster', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Stearns-Yoder', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Stamper', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Hoisington', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Brostow', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Mealer', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Hal S', 'Initials': 'HS', 'LastName': 'Wortzel', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Teodor T', 'Initials': 'TT', 'LastName': 'Postolache', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Lowry', 'Affiliation': 'VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC), Rocky Mountain Regional Veterans Affairs (VA) Medical Center (RMRVAMC), Aurora, CO, United States.'}]",Frontiers in neurology,['10.3389/fneur.2020.01015']
1995,33192984,Thin-Slice Magnetic Resonance Imaging-Based Radiomics Signature Predicts Chromosomal 1p/19q Co-deletion Status in Grade II and III Gliomas.,"Objective:  Chromosomal 1p/19q co-deletion is recognized as a diagnostic, prognostic, and predictive biomarker in lower grade glioma (LGG). This study aims to construct a radiomics signature to non-invasively predict the 1p/19q co-deletion status in LGG.  Methods:  Ninety-six patients with pathology-confirmed LGG were retrospectively included and randomly assigned into training ( n  = 78) and validation ( n  = 18) dataset. Three-dimensional contrast-enhanced T1 (3D-CE-T1)-weighted magnetic resonance (MR) images and T2-weighted MR images were acquired, and simulated-conventional contrast-enhanced T1 (SC-CE-T1)-weighted images were generated. One hundred and seven shape, first-order, and texture radiomics features were extracted from each imaging modality and selected using the least absolute shrinkage and selection operator on the training dataset. A 3D-radiomics signature based on 3D-CE-T1 and T2-weighted features and a simulated-conventional (SC) radiomics signature based on SC-CE-T1 and T2-weighted features were established using random forest. The radiomics signatures were validated independently and evaluated using receiver operating characteristic (ROC) curves. Tumors with IDH mutations were also separately assessed.  Results:  Four radiomics features were selected to construct the 3D-radiomics signature and displayed accuracies of 0.897 and 0.833, areas under the ROC curves (AUCs) of 0.940 and 0.889 in the training and validation datasets, respectively. The SC-radiomics signature was constructed with 4 features, but the AUC values were lower than that of the 3D signature. In the IDH-mutated subgroup, the 3D-radiomics signature presented AUCs of 0.950-1.000.  Conclusions:  The MRI-based radiomics signature can differentiate 1p/19q co-deletion status in LGG with or without predetermined IDH status. 3D-CE-T1-weighted radiomics features are more favorable than SC-CE-T1-weighted features in the establishment of radiomics signatures.",2020,"In the IDH-mutated subgroup, the 3D-radiomics signature presented AUCs of 0.950-1.000.  ","['Methods:  Ninety-six patients with pathology-confirmed LGG', 'Tumors with IDH mutations']",['Thin-Slice Magnetic Resonance Imaging-Based Radiomics Signature'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4287932', 'cui_str': 'IDH gene mutation'}]","[{'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",[],96.0,0.029611,"In the IDH-mutated subgroup, the 3D-radiomics signature presented AUCs of 0.950-1.000.  ","[{'ForeName': 'Ziren', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chendan', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Sirui', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Delin', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenlin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Penghao', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tianrui', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuelei', 'Initials': 'Y', 'LastName': 'Lyu', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Dachun', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",Frontiers in neurology,['10.3389/fneur.2020.551771']
1996,33200899,Holmium laser enucleation of prostate versus minimally invasive simple prostatectomy for large volume (≥ 120 ml) prostate glands: a prospective multicenter randomized study.,"BACKGROUND


The aim of this study was to compare the perioperative and functional results between laparoscopic and robot-assisted simple prostatectomy (LSP and RASP) and Holmium laser enucleation of prostate (HoLEP) in prostate volumes ≥ 120 ml. The primary endpoint was to investigate and compare minimally invasive techniques in the management of large prostate gland volume, and the secondary endpoint was to evaluate the frequency and type of postoperative complications according to Clavien Dindo classification.
METHODS


This multicentre study was conducted on male patients with LUTS associated with BPO candidates for surgical treatment. The surgery approach choice in relation to the prostatic volume ≥ 120 ml was HoLEP or minimally invasive simple prostatectomy (LSP or RASP). All patients were prospectively randomized into three groups, according to a simple computed randomization: HoLEP, LSP and RASP groups. During the follow-up, all patients underwent post-operative control at 1, 3, 6, 12 and 24 months from the surgical procedure.
RESULTS


110 male patients were randomized in three homogeneous groups: 36 in LSP, 32 in RASP and 42 in HoLEP group. During the follow-up (mean 26.15 months), despite the significant improvement compared to baseline results, no significant differences were shown, between the groups in terms of functional and perioperative outcomes. The only statistically significant data was reported for catheterization time, that resulted longer in the LSP group than RASP and HoLEP groups (p value: 0.002). Furthermore, MISP resulted in longer hospitalization, and lower rate of patients with new-onset irritative symptoms.
CONCLUSIONS


This prospective randomized study is the first to compare extraperitoneal LSP, RASP and HoLEP in the treatment of LUTS secondary to benign prostatic hyperplasia for prostate volumes ≥ 120 ml. Our findings confirm the safety and efficacy of MISP, demonstrating its equivalence in functional outcomes and perioperative morbidity in comparison to HoLEP.",2020,"The only statistically significant data was reported for catheterization time, that resulted longer in the LSP group than RASP and HoLEP groups (p value: 0.002).","['LUTS secondary to benign prostatic hyperplasia for prostate volumes ≥ 120 ml', '110 male patients were randomized in three homogeneous groups: 36 in LSP, 32 in RASP and 42 in HoLEP group', 'male patients with LUTS associated with BPO candidates for surgical treatment', 'large volume (≥ 120 ml) prostate glands']","['extraperitoneal LSP, RASP and HoLEP', 'Holmium laser enucleation of prostate versus minimally invasive simple prostatectomy', 'laparoscopic and robot-assisted simple prostatectomy (LSP and RASP', 'MISP', 'HoLEP or minimally invasive simple prostatectomy (LSP or RASP', 'Holmium laser enucleation of prostate (HoLEP']","['frequency and type of postoperative complications according to Clavien Dindo classification', 'large prostate gland volume', 'catheterization time', 'longer hospitalization']","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0995147', 'cui_str': 'Rasp'}, {'cui': 'C3698057', 'cui_str': 'Holmium laser enucleation of prostate'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0995147', 'cui_str': 'Rasp'}, {'cui': 'C3698057', 'cui_str': 'Holmium laser enucleation of prostate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C1285092', 'cui_str': 'Gland structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",110.0,0.0331764,"The only statistically significant data was reported for catheterization time, that resulted longer in the LSP group than RASP and HoLEP groups (p value: 0.002).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fuschi', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Al Salhi', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Velotti', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Capone', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Martoccia', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Paolo P', 'Initials': 'PP', 'LastName': 'Suraci', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Scalzo', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Annino', 'Affiliation': 'Urology Unit, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Khorrami', 'Affiliation': 'Urology Unit, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Asimakopoulos', 'Affiliation': 'Urology Unit, Tor Vergata Hospital, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bozzini', 'Affiliation': 'Urology Unit, Urology Department, ASST Valle Olona, Busto Arsizio, Varese, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Falsaperla', 'Affiliation': 'Urology Unit, ARNAS Garibaldi Hospital, Catania, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Carbone', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.'}, {'ForeName': 'Antonio L', 'Initials': 'AL', 'LastName': 'Pastore', 'Affiliation': 'Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy - antopast@hotmail.com.'}]",Minerva urologica e nefrologica = The Italian journal of urology and nephrology,['10.23736/S0393-2249.20.04043-6']
1997,33200905,Outcomes of combination therapy with daily Tadalafil 5mg plus Tamsulosin 0.4mg to treat lower urinary tract symptoms and erectile dysfunction in men with or without metabolic syndrome.,"BACKGROUND


To assess the impact of Tadalafil 5mg/die plus Tamsulosin 0.4mg/die combination therapy on LUTS and ED, according to presence vs. absence of Mets.
METHODS


75 consecutive men presenting with ED and LUTS were enrolled. Patients were divided into two groups according to MetS presence. All subjects were treated with combination therapy for 12 weeks. Patients were re-evaluated after treatment with Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5.
RESULTS


After enrollment, 50 patients were included: 31(62.0%) with MetS and 19(38.0%) without MetS. At baseline, patients without MetS showed a significantly better IPSS, IIEF and OAB-q, as compared to those with MetS. After 12 weeks of combination therapy LUTS, ED and flowmetry significantly improved in both groups(p<0.001). The improvement after 12 weeks was similar between groups in all parameters(p>0.05), except for ΔOAB-q that was significantly better for patients with MetS(p=0.028). Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS(p<0.05). Despite IIEF-5 was significantly different at baseline, after 12 weeks of combination therapy, erectile function was similar in men with or without METS:16.3±3.8 vs 7.7±4.7(p=0.238). No serious AE was reported and complications were comparable between groups(p>0.05).
CONCLUSIONS


Patients with MetS have worse LUTS and ED profiles. However, tadalafil plus tamsulosin combination treatment provided them a similar ED profile and a greater relief of OAB symptoms at the end of the trial. Combination therapy had the same safety profile in men besides MetS. Further randomized controlled trials are needed.",2020,"Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS(p<0.05).","['50 patients were included: 31(62.0%) with MetS and 19(38.0%) without MetS', '75 consecutive men presenting with ED and LUTS were enrolled', 'men with or without metabolic syndrome']","['tadalafil plus tamsulosin', 'Tadalafil 5mg plus Tamsulosin', 'Tadalafil 5mg/die plus Tamsulosin']","['relief of OAB symptoms', 'IPSS, IIEF and OAB-q', 'erectile function', 'Despite IIEF-5', 'total IPSS, all IPSS subscores and OAB-q', 'urinary tract symptoms and erectile dysfunction', 'Uroflowmetry and PVR, IPSS, IPSS QoL, OAB-q and IIEF-5']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1331168', 'cui_str': 'tadalafil 5 MG'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1508753', 'cui_str': 'Urinary system structure'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",75.0,0.0343944,"Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS(p<0.05).","[{'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Sebastianelli', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Morselli', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy - simone.morselli.89@gmail.com.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Spatafora', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Liaci', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gemma', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zaccaro', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vignozzi', 'Affiliation': 'Department of Clinical Physiopathology, University of Florence, Florence, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maggi', 'Affiliation': 'Department of Clinical Physiopathology, University of Florence, Florence, Italy.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'McVary', 'Affiliation': 'Center for Male Health, Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Department of Urology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Gravas', 'Affiliation': 'Department of Urology, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Serni', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Gacci', 'Affiliation': 'Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Careggi Hospital, Florence, Italy.'}]",Minerva urologica e nefrologica = The Italian journal of urology and nephrology,['10.23736/S0393-2249.20.04099-0']
1998,33200954,Shorter work boot shaft height improves ankle range of motion and decreases the oxygen cost of work.,"Work boots featuring design elements implemented to protect the foot and lower limb are common in many industries. However, boot design can have negative unintended consequences such as increases in work related fatigue and injury risk. This study compared joint kinematics and the physiological cost of two commercially available steel-toed work boots with different shaft designs worn throughout a simulated work task. A boot with a lower-cut and scalloped shaft allowed greater sagittal plane range of motion at the ankle joint compared to a boot with a higher-cut straight shaft, particularly in the late stance phase of the gait cycle. This was coupled with a decreased physiological cost of treadmill walking (2.6 and 3.1% improvement in oxygen consumption and walking economy, respectively), likely caused by a more efficient gait pattern. A lower-cut and scalloped shaft could lead to decreases in work-related fatigue and the subsequent risk of injuries in workers.  Practitioner summary:  Gait kinematics and the physiological cost of work boots with different shaft heights has not previously been investigated. A randomised cross-over study design found that a boot with a lower shaft height and scalloped collar improved ankle range of motion and reduced the physiological cost experienced by the wearers.  Abbreviations:  ROM: range of motion; FS: full shaft; SS: scalloped shaft; COM: centre of mass; HR: heart rate; RPE: rating of perceived exertion; ES: effect size.",2020,"A boot with a lower-cut and scalloped shaft allowed greater sagittal plane range of motion at the ankle joint compared to a boot with a higher-cut straight shaft, particularly in the late stance phase of the gait cycle.",[],[],"['physiological cost of treadmill walking', 'oxygen cost of work']",[],[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",,0.0226218,"A boot with a lower-cut and scalloped shaft allowed greater sagittal plane range of motion at the ankle joint compared to a boot with a higher-cut straight shaft, particularly in the late stance phase of the gait cycle.","[{'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lindsay', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Clark', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, Australia.'}, {'ForeName': 'Kahlee', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Spratford', 'Affiliation': 'University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Bruce, Australia.'}]",Ergonomics,['10.1080/00140139.2020.1838624']
1999,33200963,"""Profoundly Saddened"" Lysogene Discloses Child's Death in Phase II/III Trial.",,2020,,[],[],[],[],[],[],,0.0109059,,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Philippidis', 'Affiliation': 'Mary Ann Liebert, Inc., Publishers, New Rochelle, New York, USA.'}]",Human gene therapy,['10.1089/hum.2020.29139.bfs']
2000,33200990,A web-based relaxation interventions to face stress during social isolation: a randomized controlled trial.,"BACKGROUND


Relaxation practices might represent helpful exercises to cope with anxiety and stressful sensations and they might be of particular utility when used in web-based interventions during periods of social isolation.
OBJECTIVE


This randomized study aimed to test whether web-based relaxation practices like natural sounds, deep respiration, and body scan may promote relaxation and a positive emotional state and reduce psychomotor activation and the preoccupation related to the COVID-19 pandemics.
METHODS


Participants were randomly assigned to one of three experimental conditions. Each condition was characterized by a single on-line session of guided Square Breathing exercise, guided Body Scan exercise, or Natural Sounds. The participants listened to one of the fully automated audio clips for 7 minutes and pre-post completed self-assessed scales on perceived relaxation, psychomotor activation, level of preoccupation associated with COVID-19, and emotional state. At the end of the session, qualitative reports on subjective experience were also collected.
RESULTS


Overall, 294 participants completed 75% of the survey and 240 completed the entire survey as well as one of three randomly assigned interventions. Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19 showed a positive improvement after the audio clips. The same pattern was observed for the valence and the perceived dominance of the emotional state. Square Breathing and Body Scan yielded enhanced results compared to Natural Sound in lowering perceived stress.
CONCLUSIONS


This study provides a novel insight that can guide orient the development of future low-cost web-based interventions to reduce preoccupation and stress in the general population.
CLINICALTRIAL



INTERNATIONAL REGISTERED REPORT


RR2-10.2196/19236.",2020,"Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19 showed a positive improvement after the audio clips.","['Participants', '294 participants completed 75% of the survey and 240 completed the entire survey as well as one of three randomly assigned interventions']","['A web-based relaxation interventions', 'guided Square Breathing exercise, guided Body Scan exercise, or Natural Sounds', 'web-based relaxation practices like natural sounds, deep respiration, and body scan']","['Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19', 'relaxation, psychomotor activation, level of preoccupation associated with COVID-19, and emotional state']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",294.0,0.055817,"Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19 showed a positive improvement after the audio clips.","[{'ForeName': 'Silvia Francesca', 'Initials': 'SF', 'LastName': 'Pizzoli', 'Affiliation': 'University of Milan, Department of Oncology and Hemato Oncology, Via Festa del Perdono 7, Milan, IT.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Marzorati', 'Affiliation': 'European Institute of Oncology, Applied Research Division for Cognitive and Psychological Science, Milan, IT.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Mazzoni', 'Affiliation': 'University of Milan, Department of Oncology and Hemato Oncology, Via Festa del Perdono 7, Milan, IT.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'University of Milan, Department of Oncology and Hemato Oncology, Via Festa del Perdono 7, Milan, IT.'}]",JMIR mental health,['10.2196/22757']
2001,33201025,"Effects of high protein, low-glycemic index diet on lean body mass, strength, and physical performance in late postmenopausal women: a randomized controlled trial.","OBJECTIVE


To investigate whether increasing protein consumption to twice the recommended daily allowance (RDA) by The Institute of Medicine affects lean body mass (LBM), muscle strength, and physical performance in late postmenopausal women.
METHODS


Parallel-group randomized trial with 26 apparently healthy women aged ≥ 65 years. Participants were randomly assigned to low-glycemic index diets with protein consumption at current RDA (0.8 g/kg body weight) or twice the RDA (2RDA, 1.6 g/kg body weight). Protein intake was assessed by 24-hours urinary nitrogen excretion. Change in LBM was measured by dual-energy X-ray absorptiometry at 3 and 6 months. Secondary outcomes were appendicular lean mass, handgrip strength by dynamometry, and physical performance by gait speed.
RESULTS


Mean age was 70.8 ± 3.6 years, and mean BMI was 26.1 ± 3.5 kg/m in the overall sample. The RDA and 2RDA groups did not differ regarding baseline dietary intake. Changes from baseline in LBM (0.07 kg; 95% CI, -0.39; 0.52 kg; P = 0.100) and appendicular lean mass (0.07 kg; 95% CI, -0.34; 0.47 kg; P = 0.100) did not differ between the groups. Total body fat (-1.41 kg; 95% CI, -2.62; 0.20 kg; P = 0.019) and trunk fat mass (-0.90 kg; 95% CI, -1.55; -0.24 kg; P = 0.005) decreased similarly in both groups at the end of intervention. Adjusting for baseline BMI did not alter these findings. Handgrip strength and 4-m gait speed increased after the intervention, with no significant difference between the groups.
CONCLUSIONS


Protein intake exceeding the RDA did not increase LBM, strength, and physical performance in a sample of late postmenopausal woman consuming a low-glycemic index diet for 6 months.",2020,"Total body fat (-1.41 kg; 95% CI, -2.62; 0.20 kg; P = 0.019) and trunk fat mass (-0.90 kg; 95% CI, -1.55;","['26 apparently healthy women aged\u200a≥\u200a65 years', 'late postmenopausal women', 'Mean age was 70.8\u200a±\u200a3.6 years, and mean BMI was 26.1\u200a±\u200a3.5\u200akg/m in the overall sample']","['low-glycemic index diets with protein consumption at current RDA', 'high protein, low-glycemic index diet']","['lean body mass (LBM), muscle strength, and physical performance', 'lean body mass, strength, and physical performance', 'Handgrip strength and 4-m gait speed', 'appendicular lean mass', 'trunk fat mass', 'Total body fat', '24-hours urinary nitrogen excretion', 'Change in LBM', 'Protein intake', 'appendicular lean mass, handgrip strength by dynamometry, and physical performance by gait speed', 'LBM, strength, and physical performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowance'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",26.0,0.13807,"Total body fat (-1.41 kg; 95% CI, -2.62; 0.20 kg; P = 0.019) and trunk fat mass (-0.90 kg; 95% CI, -1.55;","[{'ForeName': 'Thaís R', 'Initials': 'TR', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Suzana C', 'Initials': 'SC', 'LastName': 'Lago', 'Affiliation': 'Gynecological Endocrinology Unit, Division of Endocrinology, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Yavorivski', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Laís L', 'Initials': 'LL', 'LastName': 'Ferreira', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Tayane M', 'Initials': 'TM', 'LastName': 'Fighera', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Poli Mara', 'Initials': 'PM', 'LastName': 'Spritzer', 'Affiliation': 'Postgraduate Program in Endocrinology and Metabolism, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001692']
2002,33201029,Comparative validity and reliability of the WeChat-based electronic and paper-and-pencil versions of the PISQ-12 for collecting participant-reported data in Chinese.,"OBJECTIVE


The objective of this study is to assess the consistency between the WeChat-based Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) in Chinese and the paper version and to determine the test-retest reliability of the WeChat questionnaire.
METHODS


A total of 120 women aged between 24 and 69 years were recruited from the outpatient clinic at Peking Union Medical College Hospital and randomly assigned to two groups. All participants completed the WeChat and paper questionnaires twice. Group A completed the paper questionnaire before the WeChat version; Group B completed the WeChat questionnaire before the paper version. Two weeks later, all participants completed the questionnaires in the opposite order. Then, the reliability and validity of the two versions were assessed using Pearson correlation coefficients, intraclass correlation coefficients, and Bland-Altman graphs.
RESULTS


No significant difference in completion time was found between the two versions of the Chinese PISQ-12 (P = 0.67). Half of the participants (60/120) preferred the WeChat questionnaire, 15% (18/120) preferred the paper form (P < 0.01), and 35% had no preference (42/120). The response time was positively correlated with age (P < 0.01) and negatively correlated with the degree of education (P < 0.01). A Pearson correlation coefficient of 0.92 and an intraclass correlation coefficient of 0.94 indicated strong consistency between the two versions. The WeChat form exhibited strong test-retest reliability (Pearson correlation coefficient, 0.86; intraclass correlation coefficient, 0.86). The Bland-Altman plots supported these results.
CONCLUSIONS


The WeChat questionnaire was preferred over the paper version in a Chinese sample and had excellent consistency with the paper version and high test-retest reliability for collecting data on private topics.",2020,No significant difference in completion time was found between the two versions of the Chinese PISQ-12 (P = 0.67).,"['Chinese', '120 women aged between 24 and 69 years were recruited from the outpatient clinic at Peking Union Medical College Hospital and randomly assigned to two groups']","['WeChat-based electronic and paper-and-pencil versions of the PISQ-12', 'WeChat-based Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12']","['completion time', 'response time', 'WeChat questionnaire']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",120.0,0.0212777,No significant difference in completion time was found between the two versions of the Chinese PISQ-12 (P = 0.67).,"[{'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhijing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jinghe', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001691']
2003,33201041,Perceptual Cognitive Training Does Not Improve Clinical Outcomes at 4 and 12 Weeks Following Concussion in Children and Adolescents: A Randomized Controlled Trial.,"OBJECTIVE


To determine whether a perceptual-cognitive training program using 3D-multiple object tracking (3D-MOT) can improve symptoms following acute pediatric concussion.
SETTING


Research laboratory within a pediatric trauma center.
PARTICIPANTS


Children and adolescents (n = 62, age= 13.27 ± 2.50) with diagnosed concussion.
DESIGN


Randomized controlled trial. Children were randomized into either 3D-MOT, 2048 game, or standard care-only groups. Participants and parents completed the Post-Concussion Symptom Inventory (PCSI) at baseline, 4, 8, and 12 weeks postinjury. Intervention participants completed either the 3D-MOT protocol or the 2048 game at 6 sessions between the baseline and 4-week assessment.
MAIN MEASURES


A 3 (group) × 10 (time) mixed-model analysis of variance evaluated PCSI total scores. The rate of persistent postconcussive symptom (PPCS) was evaluated at 4 weeks using χ analysis.
RESULTS


Symptoms decreased throughout the study using both child-reported (F(9,374) = 22.03, P < .001) and parent-reported scores (F(9,370) = 28.06, P < .001). Twenty-four (44.4%) children met the study definition for PPCS using the child-reported PCSI, while 20 (37.7%) children had PPCS using parent reports. The intervention did not significantly affect symptom resolution or PPCS rates.
CONCLUSION


There is no benefit to prescribing 3D-MOT training for acute rehabilitation in pediatric patients with concussion and clinicians should instead focus on more effective programs.",2020,"RESULTS


Symptoms decreased throughout the study using both child-reported (F(9,374) = 22.03, P < .001) and parent-reported scores (F(9,370) = 28.06, P < .001).","['Research laboratory within a pediatric trauma center', 'Children and adolescents (n = 62, age= 13.27 ± 2.50) with diagnosed concussion', 'pediatric patients with concussion and clinicians', 'Children and Adolescents']","['perceptual-cognitive training program using 3D-multiple object tracking (3D-MOT', 'Perceptual Cognitive Training', '3D-MOT protocol', 'MOT training']","['Post-Concussion Symptom Inventory (PCSI', 'rate of persistent postconcussive symptom (PPCS', 'symptom resolution or PPCS rates']","[{'cui': 'C0022886', 'cui_str': 'Laboratory Research'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0546983', 'cui_str': 'Postconcussion syndrome'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.131708,"RESULTS


Symptoms decreased throughout the study using both child-reported (F(9,374) = 22.03, P < .001) and parent-reported scores (F(9,370) = 28.06, P < .001).","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Teel', 'Affiliation': ""School of Physical and Occupational Therapy, McGill University, Montreal, Quebec, Canada (Drs Teel, Marie Brossard-Racine, and Gagnon); Division of Neonatology (Dr Marie Brossard-Racine) and Division of Pediatric Emergency Medicine (Dr Gagnon), Department of Pediatrics, Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, Canada; Department of Neurology and Neurosurgery, Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, Canada (Dr Marie Brossard-Racine); and Département des sciences de l'activité physique, Université du Québec à Trois-Rivières, Trois-Rivières, Quebec, Canada (Dr Corbin-Berrigan).""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Brossard-Racine', 'Affiliation': ''}, {'ForeName': 'Laurie-Ann', 'Initials': 'LA', 'LastName': 'Corbin-Berrigan', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gagnon', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000633']
2004,33201059,Corticosteroids Versus Cyclosporine for Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis: A Prospective Randomized Double-Blind Study.,"PURPOSE


To compare efficiency and tolerance between topical 0.5% cyclosporine A (CSA) and fluorometholone (FML) for subepithelial infiltrates (SEI) complicating epidemic keratoconjunctivitis.
METHODS


We conducted a prospective double-blind randomized study involving 72 eyes with SEI. Thirty-eight eyes were treated with topical FML (FML group) and 34 eyes with CSA 0.5% eye drops (CSA group). Treatment was considered successful in case of SEI reduction and visual acuity improvement. Tolerance was evaluated by Schirmer test value, burning on eye drops instillation, and conjunctival injection.
RESULTS


Baseline characteristics of both groups were similar (P > 0.05). After 3 months of the regimen, resolution of SEI was 3 times more observed in the FML group than that in the CSA group (P = 0.026). After 6 months, resolution of SEI was observed in 70% of the FML group and in 47% of the CSA group (P = 0.068). The recurrence of SEI was almost twice higher in the FML group than that in the CSA group (16% vs. 9%). FML was better tolerated during the first 3 months: a higher Schirmer test value (P = 0.0003), less burning on instillation (P = 0.242), and less conjunctival injection (P = 0.003). For the rest of the follow-up period, the 2 groups were comparable in tolerance. No ocular hypertension was noted.
CONCLUSIONS


Epidemic keratoconjunctivitis can evolve favorably under both FML and CSA. The effect of FML is faster and CSA is more durable with fewer recurrences. Both are safe therapeutic options for long-term control of SEI.",2020,"FML was better tolerated during the first 3 months: a higher Schirmer test value (P = 0.0003), less burning on instillation (P = 0.242), and less conjunctival injection (P = 0.003).","['Thirty-eight eyes', 'subepithelial infiltrates (SEI) complicating epidemic keratoconjunctivitis', 'Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis', '72 eyes with SEI']","['topical 0.5% cyclosporine A (CSA) and fluorometholone (FML', 'topical FML (FML', 'CSA', 'CSA 0.5% eye drops (CSA', 'Corticosteroids Versus Cyclosporine', 'FML']","['Tolerance', 'ocular hypertension', 'efficiency and tolerance', 'recurrence of SEI', 'SEI reduction and visual acuity improvement', 'tolerated', 'conjunctival injection', 'resolution of SEI']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0014493', 'cui_str': 'Epidemic keratoconjunctivitis'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0016351', 'cui_str': 'Fluorometholone'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}]",72.0,0.0991067,"FML was better tolerated during the first 3 months: a higher Schirmer test value (P = 0.0003), less burning on instillation (P = 0.242), and less conjunctival injection (P = 0.003).","[{'ForeName': 'Dhouha', 'Initials': 'D', 'LastName': 'Gouider', 'Affiliation': 'Department of Ophthalmology, Military University Hospital of Tunis, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khallouli', 'Affiliation': 'Department of Ophthalmology, Military University Hospital of Tunis, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Afef', 'Initials': 'A', 'LastName': 'Maalej', 'Affiliation': 'Department of Ophthalmology, Military University Hospital of Tunis, Faculty of Medicine of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Mohamed Ali', 'Initials': 'MA', 'LastName': 'Yousfi', 'Affiliation': 'Reseach Unit of Autoimmune Disease UR17DN02, Military University Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Ksiaa', 'Affiliation': 'Department of Ophthalmology, Fattouma Bourguiba University Hospital, Faculty of Medicine, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Chaker', 'Initials': 'C', 'LastName': 'Bouguerra', 'Affiliation': 'Reseach Unit of Autoimmune Disease UR17DN02, Military University Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Faida', 'Initials': 'F', 'LastName': 'Ajili', 'Affiliation': 'Reseach Unit of Autoimmune Disease UR17DN02, Military University Hospital of Tunis, Tunis, Tunisia.'}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Khairallah', 'Affiliation': 'Department of Ophthalmology, Fattouma Bourguiba University Hospital, Faculty of Medicine, University of Monastir, Monastir, Tunisia.'}]",Cornea,['10.1097/ICO.0000000000002589']
2005,33201089,"End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial.","OBJECTIVE


To evaluate whether systematic mesh implantation upon primary colostomy creation was effective to prevent PSH.
SUMMARY OF BACKGROUND DATA


Previous randomized trials on prevention of PSH by mesh placement have shown contradictory results.
METHODS


This was a prospective, randomized controlled trial in 18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection. Participants were randomized by blocks of random size, stratified by center in a 1:1 ratio to colostomy with or without a synthetic, lightweight monofilament mesh. Patients and outcome assessors were blinded to patient group. The primary endpoint was clinically diagnosed PSH rate at 24 months of the intention-to-treat population. This trial was registered at ClinicalTrials.gov, number NCT01380860.
RESULTS


From November 2012 to October 2016, 200 patients were enrolled. Finally, 65 patients remained in the no mesh group (Group A) and 70 in the mesh group (Group B) at 24 months with the most common reason for drop-out being death (n = 41). At 24 months, PSH was clinically detected in 28 patients (28%) in Group A and 30 (31%) in Group B [P = 0.77, odds ratio = 1.15 95% confidence interval = (0.62;2.13)]. Stoma-related complications were reported in 32 Group A patients and 37 Group B patients, but no mesh infections. There were no deaths related to mesh insertion.
CONCLUSION


We failed to show efficiency of a prophylactic mesh on PSH rate. Placement of a mesh in a retro-muscular position with a central incision to allow colon passage cannot be recommended to prevent PSH. Optimization of mesh location and reinforcement material should be performed.",2020,"There were no deaths related to mesh insertion.
","['From November 2012 to October 2016, 200 patients were enrolled', '18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection']","['End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7', 'colostomy with or without a synthetic, lightweight monofilament mesh']","['Stoma-related complications', 'clinically diagnosed PSH rate', 'PSH', 'PSH rate']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0400074', 'cui_str': 'Construction of end colostomy'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}]","[{'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",200.0,0.490255,"There were no deaths related to mesh insertion.
","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Prudhomme', 'Affiliation': 'Department of Digestive Surgery, CHU Nimes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rullier', 'Affiliation': 'Department of Digestive Surgery, GH Sud Haut-Lévêque - CHU de Bordeaux, Pessac, France.'}, {'ForeName': 'Lakkis', 'Initials': 'L', 'LastName': 'Zaher', 'Affiliation': ""Department of Digestive Surgery, L'Hôpital Jean Minjoz, CHRU de Besançon, Besançon, France.""}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Cotte', 'Affiliation': 'Department of Digestive Surgery, Center Hospitalier Lyon-Sud, Lyon, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Panis', 'Affiliation': 'Department of Colorectal Surgery, AP-HP Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Meunier', 'Affiliation': 'Department of Digestive Surgery, Hôpital Pontchaillou, Rennes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouanet', 'Affiliation': ""Department of Oncologic Surgery, Center Régional de Lutte Contre le Cancer CRLC Val d'Aurelle - Paul Lamarque, Montpellier, France.""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Digestive Surgery, Hôpital Charles-Nicolle, CHU de Rouen, Rouen, France.'}, {'ForeName': 'Jafari', 'Initials': 'J', 'LastName': 'Mehrdad', 'Affiliation': 'Department of Oncologic Surgery, Center Oscar Lambret, Lille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Portier', 'Affiliation': 'Department of Digestive Surgery, Hôpital Rangueil - CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dubois', 'Affiliation': 'Department of Digestive Surgery, CHRU Clermont- Ferrand Hôtel - Dieu, Clermont-Ferrand, France and Department of Digestive Surgery, CH de Vichy, Vichy, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Sielezneff', 'Affiliation': 'Department of Digestive Surgery, AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Parc', 'Affiliation': 'Department of Digestive Surgery, AP-HP Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Faucheron', 'Affiliation': 'Department of Digestive Surgery, Hôpital Albert Michallon, CHU de Grenoble, Grenoble, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Meurette', 'Affiliation': 'Department of Digestive Surgery, Center Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes, Nantes, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Lelong', 'Affiliation': 'Department of Oncologic Surgery, Center Régional de Lutte contre le Cancer Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'Department of Digestive Surgery, Hôpital Claude Huriez, Center Hospitalier Régional Universitaire, (CHRU) de Lille, Lille, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Karoui', 'Affiliation': 'Department of Digestive Surgery, Hôpital La Pitié Salpetrière, (AP-HP), Paris, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fabbro-Peray', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology, CHU Nimes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Demattei', 'Affiliation': 'Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology, CHU Nimes, Univ Montpellier, Nimes, France.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Bertrand', 'Affiliation': 'Department of Digestive Surgery, CHU Nimes, Univ Montpellier, Nimes, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004371']
2006,33201098,"Comment on ""Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial"".",,2020,,[],['Laparoscopic Appendicectomy'],[],[],"[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]",[],,0.699173,,"[{'ForeName': 'Wouter Jaap', 'Initials': 'WJ', 'LastName': 'Bom', 'Affiliation': 'Physician Researcher, Meibergdreef 9, Amsterdam, Netherlands Department of Surgery, Amsterdam UMC, Location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wolfhagen', 'Affiliation': ''}, {'ForeName': 'Marja A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004384']
2007,33201105,"Response to the Comment on ""Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial"".",,2020,,[],['Laparoscopic Appendicectomy'],[],[],"[{'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}]",[],,0.640735,,"[{'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery and Surgical Simulation, Monash Children's Hospital, Melbourne, Australia Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia Department of Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia Department of Pediatric Surgery and Surgical Simulation, Monash Children's Hospital, Melbourne, Australia Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia Department of Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004382']
2008,33201116,"Prophylactic Single-use Negative Pressure Dressing in Closed Surgical Wounds After Incisional Hernia Repair: A Randomized, Controlled Trial.","OBJECTIVE


A randomized controlled trial (RCT) was undertaken to evaluate whether the prophylactic application of a specific single-use negative pressure (sNPWT) dressing on closed surgical incisions after incisional hernia (IH) repair decreases the risk of surgical site occurrences (SSOs) and the length of stay.
BACKGROUND


The sNPWT dressings have been associated to several advantages like cost savings and prevention of SSOs like seroma, hematoma, dehiscence, or wound infection (SSI) in closed surgical incisions. But this beneficious effect has not been previously studied in cases of close wounds after abdominal wall hernia repairs.
METHODS


An RCT was undertaken between May 2017 and January 2020 (ClinicalTrials.gov registration number NCT03576222). Participating patients, with IH type W2 or W3 according to European Hernia Society classification, were randomly assigned to receive intraoperatively either the sNPWT (PICO)(72 patients) or a conventional dressing at the end of the hernia repair (74 patients). The primary endpoint was the development of SSOs during the first 30 days after hernia repair. The secondary endpoint included length of hospital stay. Statistical analysis was performed using IBM SPSS Statistics Version 23.0.
RESULTS


At 30 days postoperatively, there was significatively higher incidence of SSOs in the control group compared to the treatment group (29.8% vs 16.6%, P < 0.042). There was no SSI in the treatment group and 6 cases in the control group (0% vs 8%, P < 0.002). No significant differences regarding seroma, hematoma, wound dehiscence, and length of stay were observed between the groups.
CONCLUSION


The use of prophylactic sNPWT PICO dressing for closed surgical incisions following IH repair reduces significatively the overall incidence of SSOs and the SSI at 30 days postoperatively.",2020,"No significant differences regarding seroma, hematoma, wound dehiscence, and length of stay were observed between the groups.
","['Participating patients, with IH type W2 or W3 according to European Hernia Society classification', 'After Incisional Hernia Repair', 'Closed Surgical Wounds']","['Prophylactic Single-use Negative Pressure Dressing', 'sNPWT (PICO)(72 patients) or a conventional dressing at the end of the hernia repair', 'specific single-use negative pressure (sNPWT) dressing', 'prophylactic sNPWT PICO dressing']","['development of SSOs', 'length of hospital stay', 'seroma, hematoma, wound dehiscence, and length of stay', 'incidence of SSOs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1956079', 'cui_str': 'Negative-Pressure Dressings'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.157012,"No significant differences regarding seroma, hematoma, wound dehiscence, and length of stay were observed between the groups.
","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bueno-Lledó', 'Affiliation': 'Surgical Unit of Abdominal Wall. Department of Digestive Surgery, ""La Fe"" Hospital, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Ascensión', 'Initials': 'A', 'LastName': 'Franco-Bernal', 'Affiliation': ''}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Garcia-Voz-Mediano', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Torregrosa-Gallud', 'Affiliation': ''}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bonafé', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004310']
2009,33195311,Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial.,"Background:  Anti-tumor necrosis factor biological agents had been proved to have a dramatic effect in ankylosing spondylitis (AS). We aimed to determine the efficacy and safety of crossover effects of adalimumab vs. etanercept in AS patients.  Methods:  A randomized, open-label crossover study was done in patients with active AS. Patients were randomized into two sequence groups, etanercept first (treatment arm) vs. adalimumab first (control arm) 8 weeks and then switched over for another 8 weeks. The primary endpoints were the difference of the Bath AS activity index and AS disease activity score (ASDAS)crp at week 16. Secondary endpoints were ASDASesr, ASAS20, and ASAS40 response rates and the proportion of patients achieving ASDAS inactive disease and low disease activity at weeks 8 and 16. Patient global assessment and preference was grading on a numerical scale.  Results:  A total of 21 patients were screened, and 19 of them were randomly allocated into the treatment arm ( n  = 9) and control arm ( n  = 9). At baseline, age, sex, Bath AS activity index, and ASDAS of both arms were comparable ( p  > 0.05). Both arms showed dramatic improvement, whereas no significance was observed between the changes of ASDAScrp (0.90 ± 1.39 vs. 1.24 ± 1.40 at week 8,  p  = 0.612; 1.02 ± 1.22 vs. 1.26 ± 1.44 at week 16,  p  = 0.707, respectively). ASAS20 and ASAS40 response rates were also comparable at week 8 (33 vs. 44%,  p  = 1.000; 22 vs. 22%,  p  = 1.000) and week 16 (22 vs. 22%,  p  = 1.000; 22 vs. 22%, p = 1.000), respectively. Both arms were well-tolerated without a serious adverse event. Adalimumab was relatively more favorable by patients in both arms, with a total mean grading score of 0.4 (-5-5,  p  = 0.218).  Conclusion:  Etanercept and adalimumab can both dramatically improve disease activity in 16 weeks. Crossover administration of etanercept and adalimumab revealed comparable efficacy and safety.  Trial Registration:  The protocol was approved by the Institutional Review Board with the register CS08019 from Chung Shan Medical University Hospital (CSMUH), Taichung, Taiwan and registered at ClinicalTrials.gov Protocol Registration and Results System: NCT02489760.",2020,"Adalimumab was relatively more favorable by patients in both arms, with a total mean grading score of 0.4 (-5-5,  ","['patients with active AS', 'Ankylosing Spondylitis', 'AS patients', 'A total of 21 patients were screened, and 19 of them']","['Etanercept vs. Adalimumab', 'etanercept', ':  Anti-tumor necrosis factor', 'Adalimumab', 'etanercept and adalimumab', 'adalimumab vs. etanercept', 'Etanercept and adalimumab', 'adalimumab', 'ASAS20']","['disease activity', 'and ASAS40 response rates', 'ASDASesr, ASAS20, and ASAS40 response rates and the proportion of patients achieving ASDAS inactive disease and low disease activity', 'efficacy and safety', 'Bath AS activity index and AS disease activity score', 'AS activity index, and ASDAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",21.0,0.123994,"Adalimumab was relatively more favorable by patients in both arms, with a total mean grading score of 0.4 (-5-5,  ","[{'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'Department of Rheumatology & Immunology, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hsi-Kai', 'Initials': 'HK', 'LastName': 'Tsou', 'Affiliation': 'Functional Neurosurgery Division, Neurological Institute, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Pui-Ying', 'Initials': 'PY', 'LastName': 'Leong', 'Affiliation': 'Department of Rheumatology & Immunology, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chia-Yin', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Rheumatology & Immunology, Chung Shan Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Jin-Xian', 'Initials': 'JX', 'LastName': 'Huang', 'Affiliation': 'Division of Rheumatology, Department of Medicine, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}]",Frontiers in medicine,['10.3389/fmed.2020.566160']
2010,33195316,Cardiovascular and Quality of Life Outcomes of a 3-Month Physical Exercise Program in Two Brazilian Communities.,"Background:  A reduction in physical activity levels in older people is associated with declining quality of life and lower cardiorespiratory fitness levels associated with cardiovascular disease outcomes and mortality from all causes. Evidence supports the positive effect of community-based exercise (CEXE) programs on cardiovascular health and quality of life. This research aimed to examine the effects of a 3-month CEXE on health-related quality of life and cardiovascular risk factors in two Brazilian populations.  Methods:  Adults with an average age of 70.2 ± 5.4 years were recruited to engage in an individually designed group based CEXE program two to three times/week (aerobic exercise, circuit resistance training, and stretching exercises for 1 h each time). Once a week, competitions were held to improve socialization and collaboration capacity among group members. The CEXE group was compared with a sedentary group. Cardiovascular outcomes were blood pressure, triglycerides, body mass index, waist circumference, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, total cholesterol, and glycemia. Health-related quality of life was evaluated using the Short Form-36.  Results:  Of the cardiovascular outcomes studied, the CEXE program significantly reduced systolic blood pressure [5.7 (95% CI 0.2 to 11.3),  p  < 0.05] and the triglyceride-HDL-C ratio [0.8 (95% CI 0.05 to 1.5),  p  < 0.05], whereas HDL-C was significantly increased [4.4 (95% CI 0.02 to 8.8),  p  < 0.05]. A significant improvement in the Short Form-36 subscales occurred in CEXE but not in the control group: physical functioning score [increase of 24.2 (95% CI 11.8 to 36.5) vs. -9.2 (95% CI -21.5 to 3.2),  p  < 0.001], physical role functioning score [increase of 35.4 (95% CI 12.8 to 58.0) vs. 16.7 (95% CI -6.0 to 39.3),  p  < 0.01], and general health score [increase of 23.7 (95% CI: 36.9. to 10.4) vs. 2.4 (95% CI -10.9 to 15.7),  p  < 0.001].  Conclusion:  This study shows that in older adults, a 12-week physical activity program can significantly decrease cardiovascular risk and improve health-related quality of life measures. An important transferable sociocultural strategy of our exercise program was to establish social interactions during and outside the CEXE program.",2020,"A significant improvement in the Short Form-36 subscales occurred in CEXE but not in the control group: physical functioning score [increase of 24.2 (95% CI 11.8 to 36.5) vs. -9.2 (95% CI -21.5 to 3.2),  p  < 0.001], physical role functioning score [increase of 35.4 (95% CI 12.8 to 58.0) vs. 16.7 (95% CI -6.0 to 39.3),  p  < 0.01], and general health score [increase of 23.7 (95% CI: 36.9. to 10.4) vs. 2.4 (95% CI -10.9 to 15.7),  p  < 0.001].  ","['older adults', 'two Brazilian populations', 'older people', 'Methods:  Adults with an average age of 70.2 ± 5.4 years', 'Two Brazilian Communities']","['CEXE', 'community-based exercise (CEXE) programs', '3-Month Physical Exercise Program', 'CEXE program two to three times/week (aerobic exercise, circuit resistance training, and stretching exercises', 'physical activity program']","['cardiovascular health and quality of life', 'health-related quality of life and cardiovascular risk factors', 'triglyceride-HDL-C ratio', 'physical functioning score', 'Cardiovascular and Quality of Life Outcomes', 'Health-related quality of life', 'general health score', 'blood pressure, triglycerides, body mass index, waist circumference, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, total cholesterol, and glycemia', 'physical role functioning score', 'cardiovascular risk and improve health-related quality of life measures', 'systolic blood pressure', 'HDL-C', 'Short Form-36 subscales', 'physical activity levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0062152', 'cui_str': 'High density lipoprotein triglyceride'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0876724,"A significant improvement in the Short Form-36 subscales occurred in CEXE but not in the control group: physical functioning score [increase of 24.2 (95% CI 11.8 to 36.5) vs. -9.2 (95% CI -21.5 to 3.2),  p  < 0.001], physical role functioning score [increase of 35.4 (95% CI 12.8 to 58.0) vs. 16.7 (95% CI -6.0 to 39.3),  p  < 0.01], and general health score [increase of 23.7 (95% CI: 36.9. to 10.4) vs. 2.4 (95% CI -10.9 to 15.7),  p  < 0.001].  ","[{'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Pereira de Lima', 'Affiliation': 'Center of Innovation, Technology and Education (CITE), Sao Jose dos Campos Technology Park, Sao Jose dos Campos, Brazil.'}, {'ForeName': 'Severo', 'Initials': 'S', 'LastName': 'Conopca', 'Affiliation': 'Center of Innovation, Technology and Education (CITE), Sao Jose dos Campos Technology Park, Sao Jose dos Campos, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Miyabara', 'Affiliation': 'Center of Innovation, Technology and Education (CITE), Sao Jose dos Campos Technology Park, Sao Jose dos Campos, Brazil.'}, {'ForeName': 'Geovanna', 'Initials': 'G', 'LastName': 'Romeiro', 'Affiliation': 'Institute of Biomedical Engineering, Anhembi Morumbi University - Laureate International Universities, Sao Jose dos Campos, Brazil.'}, {'ForeName': 'Luciana A', 'Initials': 'LA', 'LastName': 'Campos', 'Affiliation': 'Center of Innovation, Technology and Education (CITE), Sao Jose dos Campos Technology Park, Sao Jose dos Campos, Brazil.'}, {'ForeName': 'Ovidiu C', 'Initials': 'OC', 'LastName': 'Baltatu', 'Affiliation': 'Center of Innovation, Technology and Education (CITE), Sao Jose dos Campos Technology Park, Sao Jose dos Campos, Brazil.'}]",Frontiers in medicine,['10.3389/fmed.2020.568796']
2011,33195332,Dexmedetomidine Combined With Butorphanol or Sufentanil for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Microvascular Decompression: A Randomized Controlled Trial.,"Background:  Patients undergoing microvascular decompression are often accompanied with high risk of post-operative nausea and vomiting (PONV). In this study, we compare the antiemetic efficacy of butorphanol or sufentanil combined with dexmedetomidine in patients undergoing microvascular decompression.  Methods:  Patients undergoing microvascular decompression were randomized into two groups. The primary outcome was the occurrence and severity of PONV during the 72 h after surgery. Secondary outcomes included levels of pain intensity and sedation and consumption of opioids at 1, 2, 6, 12, 24, 48, and 72 h after surgery. We also recorded the intraoperative hemodynamics, consumption of narcotic drugs, operation and anesthesia time, estimated blood loss, infusion volume and urine output, requirements of rescue antiemetics or analgesics, the satisfaction scores of patients and surgeons, complications, and length of stay.  Results:  The overall incidence rates of nausea and vomiting during the 72 h after surgery were significantly reduced in group DB (76.00 and 44.00% in group DS vs. 54.17% and 22.92% in group DB,  P  < 0.05). Patients in group DB had a lower incidence of nausea than those in group DS at intervals of 1-6 and 6-24 h ( P  < 0.05). However, patients in group DB had a lower incidence of vomiting than those in group DS only at intervals of 1-6 h ( P  < 0.05). Similarly, the number of patients requiring rescue antiemetics was also significantly reduced in group DB compared with that in group DS at intervals of 1-6 h ( P  < 0.05). The number of patients experiencing moderate to severe PONV was comparable between the two groups during 72 h after surgery ( P  > 0.05). The consumption of opioid morphine equivalent was significantly reduced in group DB ( P  < 0.05). Compared with those in group DS, the satisfaction scores of both patients and surgeons were significantly increased in group DB ( P  < 0.05).  Conclusion:  Butorphanol combined with dexmedetomidine could reduce early PONV and the number of patients requiring rescue antiemetics, especially at intervals of 1-6 h, while the satisfaction scores of both patients and surgeons were significantly increased.",2020,Patients in group DB had a lower incidence of nausea than those in group DS at intervals of 1-6 and 6-24 h ( P  < 0.05).,"['Patients Undergoing Microvascular Decompression', 'Patients undergoing microvascular decompression', 'Patients undergoing', 'patients undergoing microvascular decompression']","['sufentanil', 'Butorphanol', 'butorphanol', 'microvascular decompression', 'Dexmedetomidine', 'dexmedetomidine', 'Butorphanol or Sufentanil']","['consumption of opioid morphine equivalent', 'overall incidence rates of nausea and vomiting', 'Post-operative Nausea and Vomiting', 'intraoperative hemodynamics, consumption of narcotic drugs, operation and anesthesia time, estimated blood loss, infusion volume and urine output, requirements of rescue antiemetics or analgesics, the satisfaction scores of patients and surgeons, complications, and length of stay', 'antiemetic efficacy', 'number of patients requiring rescue antiemetics', 'nausea', 'high risk of post-operative nausea and vomiting (PONV', 'occurrence and severity of PONV', 'levels of pain intensity and sedation and consumption of opioids', 'satisfaction scores', 'vomiting', 'early PONV and the number of patients requiring rescue antiemetics', 'number of patients experiencing moderate to severe PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",,0.086711,Patients in group DB had a lower incidence of nausea than those in group DS at intervals of 1-6 and 6-24 h ( P  < 0.05).,"[{'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Zunyuan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Liaocheng People's Hospital, Liaocheng, China.""}]",Frontiers in medicine,['10.3389/fmed.2020.583031']
2012,33195349,Global Glomerulosclerosis and Segmental Glomerulosclerosis Could Serve as Effective Markers for Prognosis and Treatment of IgA Vasculitis With Nephritis.,"Background:  This study was aimed at investigating the clinical significance and curative effect of global glomerulosclerosis (GS) and segmental glomerulosclerosis (S) in adult-onset IgA vasculitis with nephritis (IgAV-N) patients since there was no consensus pathological grading method for adult IgAV-N.  Methods:  A total of 188 biopsy-proven IgAV-N patients were prospectively identified. Patients were separately assigned to GS0/GS1/GS2 group and S0/S1/S2 based on the scores of global glomerulosclerosis and segmental glomerulosclerosis (0% /0-15% />15%, respectively).  Results:  GS0, GS1, and GS2 occurred in 56.4, 29.2, and 14.4% of the adult-onset IgAV-N, respectively. Patients in GS2 group tended to have the most serious renal deterioration and the highest levels of blood pressure. IgAV-N patients were also divided into S0 group (64.4%), S1 group (20.7%), and S2 group (14.9%), where no obvious differences in baseline data were noted. K-M curves indicated that GS2 group had the worst renal outcome ( P  = 0.05) while there seemed to be no significant differences between GS0 group and GS1 group. In addition, no remarkable differences in primary outcome were found among S0 group, S1 group, and S2 group though the prognosis of S2 group tended to be the worst. However, the prognosis of S0/S1 group was markedly better than that of S2 ( P  = 0.04). The discrimination of poor prognosis could be improved by adding the pathological indicators of global glomerulosclerosis and segmental glomerulosclerosis. Most importantly, immunosuppressive treatment might be a superior alternative in IgAV-N patients without sclerosis scores or with lower level of sclerosis scores. But addition of immunosuppression was not recommended in patients with higher sclerosis scores.  Conclusions:  Global glomerulosclerosis and segmental sclerosis might be used for management and treatment of adult-onset IgAV-N.",2020,K-M curves indicated that GS2 group had the worst renal outcome ( P  = 0.05) while there seemed to be no significant differences between GS0 group and GS1 group.,"['adult-onset IgA vasculitis with nephritis (IgAV-N) patients', 'A total of 188 biopsy-proven IgAV-N patients']","['GS0/GS1/GS2', 'immunosuppression', 'global glomerulosclerosis (GS) and segmental glomerulosclerosis (S', 'GS2']","['global glomerulosclerosis and segmental glomerulosclerosis', 'blood pressure', 'serious renal deterioration', 'IgAV', 'Results:  GS0, GS1, and GS2', 'worst renal outcome']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0027697', 'cui_str': 'Nephritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0178664', 'cui_str': 'Glomerulosclerosis'}, {'cui': 'C0333497', 'cui_str': 'Segmental glomerulosclerosis'}, {'cui': 'C1868679', 'cui_str': 'Griscelli syndrome type 2'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0178664', 'cui_str': 'Glomerulosclerosis'}, {'cui': 'C0333497', 'cui_str': 'Segmental glomerulosclerosis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1859194', 'cui_str': 'Griscelli syndrome type 1'}, {'cui': 'C1868679', 'cui_str': 'Griscelli syndrome type 2'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.029051,K-M curves indicated that GS2 group had the worst renal outcome ( P  = 0.05) while there seemed to be no significant differences between GS0 group and GS1 group.,"[{'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yicong', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Gaiqin', 'Initials': 'G', 'LastName': 'Pei', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhengxia', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Padamata', 'Initials': 'P', 'LastName': 'Tarun', 'Affiliation': 'West China School of Medicine, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, Department of Medicine, West China Hospital, Sichuan University, Chengdu, China.'}]",Frontiers in medicine,['10.3389/fmed.2020.588031']
2013,33195639,Observation of the effects of three methods for reducing perineal swelling in children with developmental hip dislocation.,"BACKGROUND


Developmental dysplasia of the hip is a developmental abnormality of the hip joint that results from hypoplasia during birth and continues to deteriorate after birth.
AIM


To observe the effects of magnesium sulfate wet compress, iodophor wet compress, and ice compress on reducing postoperative perineal swelling in children with developmental hip dislocation to provide effective nursing interventions in the clinic.
METHODS


A total of 120 children with hip dislocation after surgery in a third-class A hospital from January 2018 to January 2020 were randomly divided into four groups, the magnesium sulfate wet compress group, iodophor wet compress group, ice compress group and the control group. Data such as height, weight, age, duration of surgery, intraoperative blood loss, postoperative body temperature, swelling duration, pain score, and incidence of blisters were collected and analyzed.
RESULTS


There were no significant differences in height, weight, age, duration of surgery, intraoperative blood loss, and postoperative body temperature among the four groups of children. Statistical differences were observed between the intervention groups and the control group ( P  < 0.05).
CONCLUSION


All three methods significantly reduced postoperative perineal swelling in children with developmental hip dislocation, reduced the duration of postoperative perineal swelling, reduced pain, and improved the quality of care.",2020,"CONCLUSION


All three methods significantly reduced postoperative perineal swelling in children with developmental hip dislocation, reduced the duration of postoperative perineal swelling, reduced pain, and improved the quality of care.","['120 children with hip dislocation after surgery in a third-class A hospital from January 2018 to January 2020', 'children with developmental hip dislocation']","['magnesium sulfate wet compress group, iodophor wet compress group, ice compress group and the control group', 'magnesium sulfate']","['height, weight, age, duration of surgery, intraoperative blood loss, postoperative body temperature, swelling duration, pain score, and incidence of blisters', 'duration of postoperative perineal swelling, reduced pain', 'perineal swelling', 'quality of care', 'postoperative perineal swelling', 'height, weight, age, duration of surgery, intraoperative blood loss, and postoperative body temperature']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019554', 'cui_str': 'Dislocation of hip joint'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0332260', 'cui_str': 'Compressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",120.0,0.0251328,"CONCLUSION


All three methods significantly reduced postoperative perineal swelling in children with developmental hip dislocation, reduced the duration of postoperative perineal swelling, reduced pain, and improved the quality of care.","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatric Surgery, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatric Surgery, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Mei-Ying', 'Initials': 'MY', 'LastName': 'He', 'Affiliation': 'Department of Pediatric Surgery, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Hai-Lun', 'Initials': 'HL', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatric Surgery, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Xian-Qiang', 'Initials': 'XQ', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatric Surgery, Chinese PLA General Hospital, Beijing 100853, China. wxq301@gmail.com.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i20.4719']
2014,33195707,Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial.,"Background


It is unknown whether the treatment effects of partial meniscectomy and physical therapy differ when focusing on activities most valued by patients with degenerative meniscal tears.
Purpose


To compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients' most important functional limitations as the outcome.
Study Design


Randomized controlled trial; Level of evidence, 1.
Methods


This study is part of the Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE) trial, a multicenter noninferiority randomized controlled trial conducted in 9 orthopaedic hospital departments in the Netherlands. The ESCAPE trial included 321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging-confirmed meniscal tear. Exclusion criteria were severe osteoarthritis, body mass index >35 kg/m 2 , locking of the knee, and prior knee surgery or knee instability due to an anterior or posterior cruciate ligament rupture. This study compared partial meniscectomy with physical therapy consisting of a supervised incremental exercise protocol of 16 sessions over 8 weeks. The main outcome measure was the Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS), a secondary outcome measure of the ESCAPE trial. We used crude and adjusted linear mixed-model analyses to reveal the between-group differences over 24 months. We calculated the minimal important change for the PSFS using an anchor-based method.
Results


After 24 months, 286 patients completed the follow-up. The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5). The crude overall between-group difference showed a -0.6-point difference (95% CI, -1.0 to -0.2;  P  = .004) in favor of the partial meniscectomy group. This improvement was statistically significant but not clinically meaningful, as the calculated minimal important change was 2.5 points on an 11-point scale.
Conclusion


Both interventions were associated with a clinically meaningful improvement regarding patients' most important functional limitations. Although partial meniscectomy was associated with a statistically larger improvement at some follow-up time points, the difference compared with physical therapy was small and clinically not meaningful at any follow-up time point.
Registration


NCT01850719 (ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).",2020,"The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5).","['Patients over 45 years with non-obstructive meniscal tears (ESCAPE', '286 patients completed the follow-up', 'Degenerative Meniscal Tears Using a Patient-Specific Score', 'patients with degenerative meniscal tears', 'patients with a degenerative meniscal tear, focusing on patients', 'anterior or posterior cruciate ligament rupture', '9 orthopaedic hospital departments in the Netherlands', '321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging-confirmed meniscal tear']","['partial meniscectomy with physical therapy', 'Arthroscopic Partial Meniscectomy Versus Physical Therapy', 'Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy']","['Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS', 'severe osteoarthritis, body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019961', 'cui_str': 'Hospital department'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0376241', 'cui_str': 'Dutch language'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",321.0,0.119196,"The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5).","[{'ForeName': 'Julia C A', 'Initials': 'JCA', 'LastName': 'Noorduyn', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Glastra van Loon', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke W', 'Initials': 'NW', 'LastName': 'Willigenburg', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ise K', 'Initials': 'IK', 'LastName': 'Butter', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Gwendolyne G M', 'Initials': 'GGM', 'LastName': 'Scholten-Peeters', 'Affiliation': 'Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michel W', 'Initials': 'MW', 'LastName': 'Coppieters', 'Affiliation': 'Amsterdam Movement Sciences, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Vanessa A B', 'Initials': 'VAB', 'LastName': 'Scholtes', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Eduard L A R', 'Initials': 'ELAR', 'LastName': 'Mutsaerts', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Matthijs R', 'Initials': 'MR', 'LastName': 'Krijnen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Dirk Jan F', 'Initials': 'DJF', 'LastName': 'Moojen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Derek F P', 'Initials': 'DFP', 'LastName': 'van Deurzen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Coen H', 'Initials': 'CH', 'LastName': 'Bloembergen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Wolkenfelt', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'de Gast', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Thom', 'Initials': 'T', 'LastName': 'Snijders', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniel B F', 'Initials': 'DBF', 'LastName': 'Saris', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Wolterbeek', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Neeter', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Rolf W', 'Initials': 'RW', 'LastName': 'Peters', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Igor C J B', 'Initials': 'ICJB', 'LastName': 'van den Brand', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Vos-Jakobs', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Andy B', 'Initials': 'AB', 'LastName': 'Spoor', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Taco', 'Initials': 'T', 'LastName': 'Gosens', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Rezaie', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Dirk Jan', 'Initials': 'DJ', 'LastName': 'Hofstee', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Burger', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Anton M J S', 'Initials': 'AMJS', 'LastName': 'Vervest', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Thijs A', 'Initials': 'TA', 'LastName': 'van Rheenen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Wijsbek', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ewoud R A', 'Initials': 'ERA', 'LastName': 'van Arkel', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Bregje J W', 'Initials': 'BJW', 'LastName': 'Thomassen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Schavemaker', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'van Dijk', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Kraan', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, the Netherlands.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120954392']
2015,33195750,Theory-guided interventions for Chinese patients to adapt to heart failure: A quasi-experimental study.,"Objectives


To examine the effects of the Roy Adaptation Model-based interventions on adaptation in persons with heart failure.
Methods


A quasi-experimental study was conducted in Hangzhou, China, from March 2018 to November 2019. A convenience sample of 112 participants with heart failure from a multi-campus hospital was enrolled. Participants were allocated into an intervention group ( n  = 55) and a control group ( n  = 57) according to their hospitalized campus. A culturally-tailored care plan intervention based on the Roy Adaptation Model was performed in the intervention group. The control group received bedside patient education and a regular booklet for HF home care before discharge. Heart ultrasound, Minnesota Living with Heart Failure Questionnaire (MLHFQ), a knowledge survey, Self-care Heart failure Index (SCHFI), and Coping and Adaptation Processing Scale-Short Form (CAPS-SF) were used to measure patients' levels of adaptation of physical function, self-concept, role function, and interdependence at baseline and six months after discharge.
Results


Ninety-one participants with complete data, 43 in the intervention group and 48 in the control group, were included in the analysis for the primary endpoints and showed adaptive improvement trends. Most patients in the intervention group completed 60% or more of the given interventions. At the sixth month after discharge, compared with the control group, the intervention group had improved adaptive behaviors showing higher scores of the MLHFQ (70.90 ± 22.45 vs. 54.78 ± 18.04), heart failure-related knowledge (13.79 ± 2.45 vs. 10.73 ± 4.28), SCHFI maintenance (57.67 ± 13.22 vs. 50.35 ± 10.88), and CAPS-SF (40.23 ± 4.36 vs. 38.27 ± 2.60) at the six-month follow-up ( P  ＜ 0.05). There were no significant differences between the two groups in the scores of left ventricular ejection fraction, scores of SCHFI management and SCHFI confidence subscales ( P  > 0.05).
Conclusions


The findings reported evidence of positive adaptation in patients with heart failure, indicating that the Roy Adaptation Model is an effective guide for developing an implemented framework for the nursing practice of the patients. The culturally-tailored care plan intervention is helpful to improve adaptation of patients with heart failure.",2020,"There were no significant differences between the two groups in the scores of left ventricular ejection fraction, scores of SCHFI management and SCHFI confidence subscales ( P  > 0.05).
","['Chinese patients to adapt to heart failure', 'Methods\n\n\nA quasi-experimental study was conducted in Hangzhou, China, from March 2018 to November 2019', 'persons with heart failure', 'patients with heart failure', '112 participants with heart failure from a multi-campus hospital was enrolled']","['bedside patient education and a regular booklet for HF home care before discharge', 'Roy Adaptation Model-based interventions']","['Heart ultrasound, Minnesota Living with Heart Failure Questionnaire (MLHFQ), a knowledge survey, Self-care Heart failure Index (SCHFI), and Coping and Adaptation Processing Scale-Short Form (CAPS-SF', 'adaptive behaviors', 'heart failure-related knowledge', 'scores of left ventricular ejection fraction, scores of SCHFI management and SCHFI confidence subscales', 'SCHFI maintenance']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0085880', 'cui_str': 'Adaptation behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",112.0,0.0288174,"There were no significant differences between the two groups in the scores of left ventricular ejection fraction, scores of SCHFI management and SCHFI confidence subscales ( P  > 0.05).
","[{'ForeName': 'Xiyi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Leiwen', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Nursing, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Howell', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Ruolin', 'Initials': 'R', 'LastName': 'Qiu', 'Affiliation': 'Department of Nursing, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Department of Nursing, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.'}]",International journal of nursing sciences,['10.1016/j.ijnss.2020.09.004']
2016,33195751,Use of mobile-stroke risk scale and lifestyle guidance promote healthy lifestyles and decrease stroke risk factors.,"Objective


The purpose of this study was to determine the effectiveness of Mobile-Stroke Risk Scale and Life Style Guidance (M-SRSguide) in promoting a healthy lifestyle and reducing stroke risk factors in at-risk persons.
Methods


This research was an clinical trial with a pre-test and post-test control group design. The accessible population is persons at risk of stroke in the community (West and East Kalimantan Province, Indonesia). Thirty-two participants in the intervention group and 32 participants in the control group participated in this study. The sampling method was systematic random sampling. We allocate the sample into the intervention and control groups using a randomized block design. The intervention group used the M-SRSguide. The control group used manual book for a self-assessment of stroke risk. The measurement of a healthy lifestyle and the stroke risk factors was performed before and six months after the intervention.
Results


There are no significant differences in healthy lifestyle and stroke risk factors between the two groups after the intervention ( P  > 0.05). Analysis of healthy lifestyle behavior assessment items in the intervention group showed an increase in healthy diets, activity patterns, and stress control after the use of the M-SRSguide ( P  < 0.01).
Conclusion


The use of M-SRSguide is effective in promoting a healthy lifestyle.",2020,"Analysis of healthy lifestyle behavior assessment items in the intervention group showed an increase in healthy diets, activity patterns, and stress control after the use of the M-SRSguide ( P  < 0.01).
","['Thirty-two participants in the intervention group and 32 participants in the control group participated in this study', 'at-risk persons']","['M-SRSguide', 'Mobile-Stroke Risk Scale and Life Style Guidance (M-SRSguide', 'mobile-stroke risk scale and lifestyle guidance']","['healthy lifestyle and stroke risk factors', 'healthy diets, activity patterns, and stress control', 'stroke risk factors']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",32.0,0.0292011,"Analysis of healthy lifestyle behavior assessment items in the intervention group showed an increase in healthy diets, activity patterns, and stress control after the use of the M-SRSguide ( P  < 0.01).
","[{'ForeName': 'Kelana Kusuma', 'Initials': 'KK', 'LastName': 'Dharma', 'Affiliation': 'School of Nursing, Politeknik Kesehatan Kementerian Kesehatan Pontianak, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Parellangi', 'Affiliation': 'School of Nursing, Politeknik Kesehatan Kementerian Kesehatan Kalimantan Timur, Indonesia.'}]",International journal of nursing sciences,['10.1016/j.ijnss.2020.08.001']
2017,33195868,Inspiratory muscle training on lung function of male roller hockey players: a randomized controlled trial pilot study.,"Background


There is evidence that inspiratory muscle training (IMT) increases the athlete's performance by decreasing the work of the respiratory muscles during exercise. IMT has shown positive results in the pulmonary function of athletes, and it was hypothesized that 4 weeks of intervention could increase lung function at rest. Investigate the influence of IMT on lung function of male roller hockey players.
Methods


Eleven male roller hockey players were randomized and allocated in the experimental group (EG) or control group (CG). Forced expiratory volume in first second, forced vital capacity, and peak expiratory flow (PEF) were assessed with spirometry, in the beginning of the study and 4 weeks later. The EG (n = 6) was submitted to an IMT using a threshold during 4 weeks, 3 times a week, 30 repetitions with 50% of maximal inspiratory pressure. The CG (n = 5) was not submitted to any intervention.
Results


Baseline pulmonary variables, forced expiratory volume in first second, forced vital capacity, and PEF, sociodemographic, and anthropometric characteristics were not significantly different among EG and CG. Significant increase on PEF ( P  = .033) was found in the EG after IMT.
Conclusion


IMT with threshold seems to have a positive impact on PEF in roller hockey players. These findings may be corroborated by further controlled randomized studies.",2020,"Significant increase on PEF ( P  = .033) was found in the EG after IMT.
","['Eleven male roller hockey players', 'male roller hockey players']","['inspiratory muscle training (IMT', 'IMT', 'control group (CG', 'Inspiratory muscle training']","['forced expiratory volume in first second, forced vital capacity, and PEF, sociodemographic, and anthropometric characteristics', 'Forced expiratory volume in first second, forced vital capacity, and peak expiratory flow (PEF', 'lung function', 'PEF']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0016074', 'cui_str': 'Field hockey'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",11.0,0.0267594,"Significant increase on PEF ( P  = .033) was found in the EG after IMT.
","[{'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Ramos', 'Affiliation': 'Faculty of Health Sciences, Fernando Pessoa University.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Barreira', 'Affiliation': 'FP-ENAS (UFP Energy, Environment and Health Research Unit), Faculty of Health Sciences, Fernando Pessoa University.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Viana', 'Affiliation': 'Faculty of Health Sciences, Fernando Pessoa University.'}]",Porto biomedical journal,['10.1097/j.pbj.0000000000000075']
2018,33195885,Precave: Immediate neoadjuvant instillation of chemotherapy for the prevention of non-muscle invasive bladder carcinoma recurrence: A prospective randomized clinical trial protocol.,"Introduction and objectives


Recurrence rates for patients presenting with non-muscle invasive bladder carcinoma (NMIBC) can be as high as 60% during the first year after a transurethral resection of bladder tumor (TURBT). Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease. Although in real clinical practice this specific instillation of chemotherapy has many difficulties to be standardized, including its contraindications (suspected or confirmed bladder perforation, wide or extensive resection and, continuous bladder irrigation requirement), which will only make it feasible for around 30% of patients.We propose in this controlled study, to administer an immediate neoadjuvant instillation of chemotherapy (INAIC), which can be applied technically to all patients, no matter the surgical outcomes and compare it with a control group. We expect to find a reduction in the recurrence rate in the experimental group of at least 15%.
Methods


We designed a phase IV, randomized, controlled, open label clinical trial. Main inclusion criteria are: patients with a clinical diagnosis of localized, papillary-type bladder cancer (suspected low to intermediate risk) with a disease-free interval of at least 6 months. Eligible patients will be allocated into group A (INAIC plus TURBT) or group B (TURBT) using a computer-generated block randomization sequence/ratio 1:1. Time to recurrence of both groups will be analyzed and compared using Kaplan-Meier estimates, log-rank tests and, Cox-regression. Univariate and multivariate analyzes will be performed to determine factors which influence recurrence. The study has received the approval of the Ethics Committee for Drug Research (CEIm) of La Paz University Hospital and the Spanish Agency for Medicines and Health Products.",2020,"Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease.","['Main inclusion criteria are: patients with a clinical diagnosis of localized, papillary-type bladder cancer (suspected low to intermediate risk) with a disease-free interval of at least 6\xa0months', 'patients with low to intermediate risk disease', 'non-muscle invasive bladder carcinoma recurrence', 'patients presenting with non-muscle invasive bladder carcinoma (NMIBC']","['chemotherapy (IPOIC', 'INAIC plus TURBT', 'chemotherapy (INAIC', 'chemotherapy']",['recurrence rate'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0699885', 'cui_str': 'Carcinoma of bladder'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0870982,"Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease.","[{'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Carrion', 'Affiliation': 'Department of Urology, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gómez Rivas', 'Affiliation': 'Department of Urology, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ballesteros Ruiz', 'Affiliation': 'Department of Urology, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Maestro', 'Affiliation': 'Department of Urology, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Aguilera Bazán', 'Affiliation': 'Department of Urology, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martínez-Piñeiro', 'Affiliation': 'Department of Urology, La Paz University Hospital, Madrid, Spain.'}]",International journal of surgery protocols,['10.1016/j.isjp.2020.10.001']
2019,33196038,Buffered lidocaine for paracervical blocks in first-trimester abortions: a randomized controlled trial.,"Objective


The objective was to evaluate if buffered lidocaine decreases injection pain as compared to plain lidocaine for paracervical blocks during first-trimester outpatient surgical abortions.
Study design


We conducted a randomized, double-blind, placebo-controlled trial among women undergoing outpatient uterine aspiration of a first-trimester pregnancy or an early pregnancy loss. Subjects received a paracervical block with either lidocaine 1% 20 mL or lidocaine 1% 18 mL plus sodium bicarbonate 8.4% 2 mL. The primary outcome was pain from injection of the paracervical block measured on a 100-mm visual analog scale (VAS). Secondary outcomes included pain after cervical dilation, uterine aspiration and overall satisfaction with pain control. Scores were compared using the Mann-Whitney  U  test. We aimed to detect a 15-mm difference in pain from injection of the paracervical block.
Results


From May 2017 to October 2018, 48 women received plain lidocaine and 50 women received buffered lidocaine. Groups were similar in demographics. We found no clinically or statistically meaningful difference in pain when evaluating median VAS scores for paracervical block injection between the buffered and plain lidocaine [30.0 (interquartile range (IQR) 15.3-64.5); 44.5 (IQR 18.3-65), respectively, p = .32]. We found no difference in secondary outcomes between buffered and plain lidocaine.
Conclusion


Buffered lidocaine for paracervical blocks in first-trimester outpatient surgical abortions does not decrease injection pain as compared to plain lidocaine.
Implications statement


Buffering the paracervical block in first-trimester outpatient surgical abortions does not decrease injection pain as compared to plain lidocaine, nor does it increase patient satisfaction. Eliminating sodium bicarbonate allows for a more cost-effective and readily available solution for paracervical blocks.",2020,"Buffered lidocaine for paracervical blocks in first-trimester outpatient surgical abortions does not decrease injection pain as compared to plain lidocaine.
","['From May 2017 to October 2018, 48 women received', 'women undergoing outpatient uterine aspiration of a first-trimester pregnancy or an early pregnancy loss', 'first-trimester outpatient surgical abortions', 'first-trimester abortions']","['placebo', 'plain lidocaine', 'paracervical block with either lidocaine 1% 20\u202fmL or lidocaine 1% 18\u202fmL plus sodium bicarbonate 8.4% 2\u202fmL', 'lidocaine', 'sodium bicarbonate']","['pain from injection of the paracervical block measured on a 100-mm visual analog scale (VAS', 'injection pain', 'median VAS scores', 'pain after cervical dilation, uterine aspiration and overall satisfaction with pain control', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C4517876', 'cui_str': '8.4'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.619028,"Buffered lidocaine for paracervical blocks in first-trimester outpatient surgical abortions does not decrease injection pain as compared to plain lidocaine.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chin', 'Affiliation': ""University of Hawaii, Department of Obstetrics, Gynecology, and Women's Health, 1319 Punahou St., Suite 824, Honolulu, HI 96826, USA.""}, {'ForeName': 'Bliss', 'Initials': 'B', 'LastName': 'Kaneshiro', 'Affiliation': ""University of Hawaii, Department of Obstetrics, Gynecology, and Women's Health, 1319 Punahou St., Suite 824, Honolulu, HI 96826, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Elia', 'Affiliation': ""University of Hawaii, Department of Obstetrics, Gynecology, and Women's Health, 1319 Punahou St., Suite 824, Honolulu, HI 96826, USA.""}, {'ForeName': 'Shandhini', 'Initials': 'S', 'LastName': 'Raidoo', 'Affiliation': ""University of Hawaii, Department of Obstetrics, Gynecology, and Women's Health, 1319 Punahou St., Suite 824, Honolulu, HI 96826, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Savala', 'Affiliation': ""University of Hawaii, Department of Obstetrics, Gynecology, and Women's Health, 1319 Punahou St., Suite 824, Honolulu, HI 96826, USA.""}, {'ForeName': 'Reni', 'Initials': 'R', 'LastName': 'Soon', 'Affiliation': ""University of Hawaii, Department of Obstetrics, Gynecology, and Women's Health, 1319 Punahou St., Suite 824, Honolulu, HI 96826, USA.""}]",Contraception: X,['10.1016/j.conx.2020.100044']
2020,33196083,Can Visual Cues to Portion Size Reduce the Number of Portions of Consumed? Two Randomized Controlled Trials.,"BACKGROUND


Since 1950, the portion size of many snack foods has more than doubled and obesity rates have tripled. Portion size determines energy intake, often unwittingly.
PURPOSE


This paper tests whether salient visual cues to portion size on the packaging of high fat, sugar, or salty (HFSS) snacks can reduce consumption.
METHODS


Two preregistered randomized controlled trials (N = 253 and N = 674) measured consumption in a lab and the home environment. Cues were salient, labeled stripes that demarcated single portions. Participants were randomized to cue condition or control. Consumption was measured without awareness.
RESULTS


The main preregistered effect of the visual cue was not statistically significant. There was some variation by subgroup. In Study 1, men were more likely to eat the whole can of potato chips than women but significantly reduced consumption when visual cues were on the pack. The effect size was large: the number of men eating more than the recommended portion fell by 33%. Study 2 monitored household consumption of chocolate biscuits (cookies) sent to family homes in gift packs. Again, the main effect was nonsignificant but there was significant subgroup variation. When the person receiving the biscuits was female, households were more likely to eat more than the recommended portion per person per day, but less likely when the visual cues were displayed. The gender of the eaters was not known. The effect size was again large: the number of households eating more than the recommended portion fell by 26%. Households with children were also less likely to open packs with visual cues compared to control packs. Both studies recorded significant increases in the likelihood of observing serving size information, together with confusion about what it means.
CONCLUSIONS


The studies offer some evidence that salient visual cues could play a role in tackling the high consumption of unhealthy snacks, but the effects are confined to specific subgroups and warrant further investigation.",2020,"Again, the main effect was nonsignificant","['Study 2 monitored household consumption of chocolate biscuits (cookies) sent to family homes in gift packs', 'Households with children', 'Two preregistered randomized controlled trials (N = 253 and N = 674) measured consumption in a lab and the home environment']",['cue condition or control'],['visual cue'],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0020047', 'cui_str': 'Household Consumption'}, {'cui': 'C0452502', 'cui_str': 'Chocolate biscuit'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",,0.056998,"Again, the main effect was nonsignificant","[{'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Robertson', 'Affiliation': 'Behavioural Research Unit, Economic and Social Reserach Institute, Dublin, Ireland.'}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Lavin', 'Affiliation': 'Behavioural Research Unit, Economic and Social Reserach Institute, Dublin, Ireland.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Lunn', 'Affiliation': 'Behavioural Research Unit, Economic and Social Reserach Institute, Dublin, Ireland.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa098']
2021,33189111,A Randomized Control Trial Comparing Local Autografts and Allografts in Single Level Anterior Cervical Discectomy and Fusion Using a StandAlone Cage.,"Study Design


Randomized controlled trial.
Purpose


To compare the functional and radiological outcomes of anterior cervical discectomy and fusion (ACDF) using local graft and allograft.
Overview of Literature


The choice of bone grafts for ACDF varies among different types: iliac crest, allograft, and substitutes. Availability, cost, and donor site morbidity are potential disadvantages. Local osteophyte grafts are then advantageous and shows to have good fusion.
Methods


We randomly sampled participants requiring a single level ACDF for degenerative conditions (n=27) between allograft (n=13) and local graft (n=14) groups. Follow-up of patients occurred at 6 weeks, 3 months, 6 months, and 1 year using Numerical Pain Rating Scale (NPRS) scores for arm and neck pain, Neck Disability Index (NDI), 2-item Short Form Health Survey (SF-12), and lateral disk height. We then assessed radiological fusion using computed tomography (CT) scan at 12 months, and graded as F- (no fusion), F (fusion seen through the cage), F+ (fusion seen through the cage, with bridging bone at one lateral edge), and F++ (fusion seen through cage with bridging bone bilaterally).
Results


There were no significant differences in the age, sex, duration of intervention, blood loss, and hospital stay between the two groups (p>0.05). Both groups showed significant improvements in all functional outcome scores including NPRS for arm and neck pain, NDI, and SF-12 at each visit (p<0.01). We observed a marked improvement in disk height in both groups (p<0.05), but at 1 year of follow-up, there was a significant though slight subsidence (p=0.47). CT at 1 year showed no non-unions. We recorded F, F+, and F++ grades of fusion in 23.2%, 38.4%, and 38.4% in allograft group and 28.6%, 42.8%, and 28.6% in local graft group, respectively, though no significant differences observed (p=0.73).
Conclusions


Marginal osteophytes are effective as graft inside cages for ACDF, since they provide similar radiological outcomes, and equivalent improvements in functional outcomes, as compared to allografts.",2020,"Both groups showed significant improvements in all functional outcome scores including NPRS for arm and neck pain, NDI, and SF-12 at each visit (p<0.01).",['randomly sampled participants requiring a single level ACDF for degenerative conditions (n=27) between allograft (n=13) and local graft (n=14) groups'],"['Local Autografts and Allografts', 'anterior cervical discectomy and fusion (ACDF) using local graft and allograft', 'CT']","['disk height', 'Availability, cost, and donor site morbidity', 'Numerical Pain Rating Scale (NPRS) scores for arm and neck pain, Neck Disability Index (NDI), 2-item Short Form Health Survey (SF-12), and lateral disk height', 'functional outcome scores including NPRS for arm and neck pain, NDI, and SF-12 at each visit (p<0.01', 'age, sex, duration of intervention, blood loss, and hospital stay']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",27.0,0.0660503,"Both groups showed significant improvements in all functional outcome scores including NPRS for arm and neck pain, NDI, and SF-12 at each visit (p<0.01).","[{'ForeName': 'Rishi Mugesh', 'Initials': 'RM', 'LastName': 'Kanna', 'Affiliation': 'Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, India.'}, {'ForeName': 'Ashok Sri', 'Initials': 'AS', 'LastName': 'Perambuduri', 'Affiliation': 'Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, India.'}, {'ForeName': 'Ajoy Prasad', 'Initials': 'AP', 'LastName': 'Shetty', 'Affiliation': 'Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, India.'}, {'ForeName': 'Shanmuganathan', 'Initials': 'S', 'LastName': 'Rajasekaran', 'Affiliation': 'Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, India.'}]",Asian spine journal,['10.31616/asj.2020.0182']
2022,33189113,Lateral Mass Screw Fixation in the Cervical Spine: Introducing a New Technique.,"Study Design


This was designed as a randomized double blind study to compare the classical Magerl technique of insertion of lateral mass screws with the authors' technique. The observations regarding length, outcome, and radiology was done by a group blinded to the technique used.
Purpose


The present study was designed with the objective of identifying the optimal technique for introducing the lateral mass screws that uses the maximum possible dimension of the lateral mass.
Overview of Literature


Lateral mass screw fixation is a common surgery that is performed in the cervical spine. Various modifications for the procedure have been described, such as changes in the entry point, angulation of the screws, and modifications in the exit point. These do not allow the insertion of longer screws that can give more purchase on the bone.
Methods


From January 1, 2009 to December 31, 2018, 176 patients who were scheduled to undergo lateral mass screw fixation were enrolled. They were randomized into two groups; we inserted lateral mass screws using our new technique for one group and by using the classical Magerl technique for the other group. Intraoperative measurements were used to assess the bone-screw interface length. Postoperative radiography and postoperative computed tomography were performed to assess the trajectory of the screws.
Results


Total 88 patients were included in the study group, including 68 men. The control group included 65 men. The most common indication for surgery was cervical spondylotic myelopathy. The average bi-cortical length that was measured intraoperatively was 19.9 mm in the study group and 16.3 mm in the control group. This was significantly different from the average lengths of screws in the control group.
Conclusions


The trajectory that involves an entry point as close as possible to the posterior inferior medial angle of the lateral mass cuboid and traverses a distance of about 20 mm to obtain a bi-cortical purchase in the diagonally opposite angle may provide a much better and firmer bony purchase in the lateral mass than conventional points of entry and trajectories.",2020,"This was significantly different from the average lengths of screws in the control group.
","['Methods\n\n\nFrom January 1, 2009 to December 31, 2018, 176 patients who were scheduled to undergo lateral mass screw fixation were enrolled', 'Cervical Spine', 'Total 88 patients were included in the study group, including 68 men', '65 men']","['Lateral Mass Screw Fixation', 'inserted lateral mass screws using our new technique for one group and by using the classical Magerl technique for the other group', 'Postoperative radiography and postoperative computed tomography']","['average lengths of screws', 'average bi-cortical length']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}]",88.0,0.0996614,"This was significantly different from the average lengths of screws in the control group.
","[{'ForeName': 'Sreeramalingam', 'Initials': 'S', 'LastName': 'Rathinavelu', 'Affiliation': 'Department of Neurosurgery, Park Clinic, Kolkata, India.'}, {'ForeName': 'Ariful', 'Initials': 'A', 'LastName': 'Islam', 'Affiliation': 'Department of Neurosurgery, Park Clinic, Kolkata, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Shivhare', 'Affiliation': 'Department of Neurosurgery, Park Clinic, Kolkata, India.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Neurosurgery, Park Clinic, Kolkata, India.'}]",Asian spine journal,['10.31616/asj.2020.0143']
2023,33189161,"Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection carries a substantial risk of severe and prolonged illness; treatment options are currently limited. We assessed the efficacy and safety of inhaled nebulised interferon beta-1a (SNG001) for the treatment of patients admitted to hospital with COVID-19.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 2 pilot trial at nine UK sites. Adults aged 18 years or older and admitted to hospital with COVID-19 symptoms, with a positive RT-PCR or point-of-care test, or both, were randomly assigned (1:1) to receive SNG001 (6 MIU) or placebo by inhalation via a mouthpiece daily for 14 days. The primary outcome was the change in clinical condition on the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period in the intention-to-treat population (all randomised patients who received at least one dose of the study drug). The OSCI is a 9-point scale, where 0 corresponds to no infection and 8 corresponds to death. Multiple analyses were done to identify the most suitable statistical method for future clinical trials. Safety was assessed by monitoring adverse events for 28 days. This trial is registered with Clinicaltrialsregister.eu (2020-001023-14) and ClinicalTrials.gov (NCT04385095); the pilot trial of inpatients with COVID-19 is now completed.
FINDINGS


Between March 30 and May 30, 2020, 101 patients were randomly assigned to SNG001 (n=50) or placebo (n=51). 48 received SNG001 and 50 received placebo and were included in the intention-to-treat population. 66 (67%) patients required oxygen supplementation at baseline: 29 in the placebo group and 37 in the SNG001 group. Patients receiving SNG001 had greater odds of improvement on the OSCI scale (odds ratio 2·32 [95% CI 1·07-5·04]; p=0·033) on day 15 or 16 and were more likely than those receiving placebo to recover to an OSCI score of 1 (no limitation of activities) during treatment (hazard ratio 2·19 [95% CI 1·03-4·69]; p=0·043). SNG001 was well tolerated. The most frequently reported treatment-emergent adverse event was headache (seven [15%] patients in the SNG001 group and five [10%] in the placebo group). There were three deaths in the placebo group and none in the SNG001 group.
INTERPRETATION


Patients who received SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection than patients who received placebo, providing a strong rationale for further trials.
FUNDING


Synairgen Research.",2020,Patients receiving SNG001 had greater odds of improvement on the OSCI scale (odds ratio 2·32 [95% CI 1·07-5·04]; p=0·033) on day 15 or 16 and were more likely than those receiving placebo to recover to an OSCI score of 1 (no limitation of activities) during treatment (hazard ratio 2·19,"['Adults aged 18 years or older and admitted to hospital with COVID-19 symptoms, with a positive RT-PCR or point-of-care test, or both', 'Between March 30 and May 30, 2020', 'inpatients with COVID-19 is now completed', '101 patients', 'SARS-CoV-2 infection', 'patients admitted to hospital with COVID-19']","['inhaled nebulised interferon beta-1a (SNG001', 'placebo', 'SNG001 ', 'SNG001', 'SNG001 (6 MIU) or placebo']","['headache', 'Safety', 'Safety and efficacy', 'efficacy and safety', 'OSCI scale', 'OSCI score of 1 (no limitation of activities', 'tolerated', 'change in clinical condition on the WHO Ordinal Scale for Clinical Improvement (OSCI', 'oxygen supplementation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439455', 'cui_str': 'mIU'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}]",101.0,0.754636,Patients receiving SNG001 had greater odds of improvement on the OSCI scale (odds ratio 2·32 [95% CI 1·07-5·04]; p=0·033) on day 15 or 16 and were more likely than those receiving placebo to recover to an OSCI score of 1 (no limitation of activities) during treatment (hazard ratio 2·19,"[{'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Monk', 'Affiliation': 'Synairgen Research, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Marsden', 'Affiliation': 'Synairgen Research, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Tear', 'Affiliation': 'Synairgen Research, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Brookes', 'Affiliation': 'Synairgen Research, Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Toby N', 'Initials': 'TN', 'LastName': 'Batten', 'Affiliation': 'Veramed, Regal House, Twickenham, UK.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Mankowski', 'Affiliation': 'TranScrip Partners, Wokingham, UK.'}, {'ForeName': 'Felicity J', 'Initials': 'FJ', 'LastName': 'Gabbay', 'Affiliation': 'TranScrip Partners, Wokingham, UK.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Davies', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Sir Henry Wellcome Laboratories, Southampton, UK.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Holgate', 'Affiliation': 'Synairgen Research, Southampton General Hospital, Southampton, UK; NIHR Southampton Biomedical Research Centre, University Hospital Southampton, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Sir Henry Wellcome Laboratories, Southampton, UK.'}, {'ForeName': 'Ling-Pei', 'Initials': 'LP', 'LastName': 'Ho', 'Affiliation': 'MRC Human Immunology Unit, MRC Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Headington, UK.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Clark', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Sir Henry Wellcome Laboratories, Southampton, UK.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Djukanovic', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Sir Henry Wellcome Laboratories, Southampton, UK.'}, {'ForeName': 'Tom M A', 'Initials': 'TMA', 'LastName': 'Wilkinson', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Sir Henry Wellcome Laboratories, Southampton, UK. Electronic address: t.wilkinson@soton.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30511-7']
2024,33189179,Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.,"BACKGROUND


Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception.
METHODS


We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete).
FINDINGS


Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred.
INTERPRETATION


Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception.
FUNDING


National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).",2020,"No serious adverse events occurred.
","['29 UK pharmacies among women receiving levonorgestrel emergency contraception', 'Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate', 'women presenting to community pharmacies for emergency contraception (Bridge-It', 'Most women in the UK obtain emergency contraception from community pharmacies', 'Between Dec 19, 2017, and June 26, 2019', '636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1']","['progestogen-only pill with emergency contraception', '3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic', 'progestogen-only pill']","['use of effective contraception (hormonal or intrauterine', 'proportion of women using effective contraception']","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",636.0,0.116296,"No serious adverse events occurred.
","[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK; Chalmers Sexual and Reproductive Health, NHS Lothian, Edinburgh, UK. Electronic address: sharon.cameron@ed.ac.uk.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDaid', 'Affiliation': 'Institute for Social Science Research, The University of Queensland, Brisbane, QLD, Australia; MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Directorate of Public Health, NHS Tayside, Dundee, UK; Division of Cardiovascular Medicines and Diabetes, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Stephenson', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Battison', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Cowle', 'Affiliation': 'Boots UK, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Patterson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Thenmalar', 'Initials': 'T', 'LastName': 'Vadiveloo', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31785-2']
2025,33201227,Impact of Exercise on Older Adults' Mood is Moderated by Sleep and Mediated by Altered Brain Connectivity.,"Older adults comprise the fastest growing global demographic and are at increased risk of poor mental health outcomes. Although aerobic exercise and sleep are critical to the preservation of emotional well-being, few studies have examined their combined mood-enhancing effects, or the potential neural mechanisms underlying these effects. Here, we used a randomized cross-over design to test the impact of acute exercise on mood and the intrinsic functional connectivity (iFC) of the cingulo-opercular network in physically healthy older adults. Wrist actigraphy provided objective indices of sleep. Results revealed that 30-minutes of moderate-intensity aerobic exercise acutely enhanced positive affect (PA) and reduced iFC between the cingulo-opercular network and the hippocampus. Both effects were magnified among older adults with greater sleep disturbance. Exercise-induced changes in hippocampal iFC mediated relations between sleep disturbance and exercise-induced increases in PA. These findings provide evidence that aerobic exercise enhances mood, that it does so by altering connectivity between the anterior insula-a key hub in the cingulo-opercular network-and the hippocampus, and that lower sleep quality is a stronger predictor of these effects among older adults. These observations underscore the benefits of moderate-intensity exercise-a safe and scalable behavioral intervention-and provide new clues about the neural circuitry underlying the interactive effects of sleep and exercise on mood.",2020,Results revealed that 30-minutes of moderate-intensity aerobic exercise acutely enhanced positive affect (PA) and reduced iFC between the cingulo-opercular network and the hippocampus.,"['older adults', 'Older adults', 'older adults with greater sleep disturbance', 'Older Adults', 'physically healthy older adults']","['aerobic exercise', 'Exercise', 'acute exercise']",['moderate-intensity aerobic exercise acutely enhanced positive affect (PA) and reduced iFC'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0531436,Results revealed that 30-minutes of moderate-intensity aerobic exercise acutely enhanced positive affect (PA) and reduced iFC between the cingulo-opercular network and the hippocampus.,"[{'ForeName': 'Alfonso J', 'Initials': 'AJ', 'LastName': 'Alfini', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Junyeon', 'Initials': 'J', 'LastName': 'Won', 'Affiliation': 'Department of Kinesiology, University of Maryland School of Public Health, College Park, MD, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Weiss', 'Affiliation': 'Department of Kinesiology, University of Maryland School of Public Health, College Park, MD, USA.'}, {'ForeName': 'Casandra C', 'Initials': 'CC', 'LastName': 'Nyhuis', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Shackman', 'Affiliation': 'Neuroscience and Cognitive Science Program, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'J Carson', 'Initials': 'JC', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology, University of Maryland School of Public Health, College Park, MD, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa149']
2026,33201232,Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes: A Randomized Clinical Trial.,"Importance


Effective strategies for preventing type 2 diabetes are needed. Many people turn to complementary medicines, but there is little well-conducted scientific evidence to support their use.
Objective


To assess the efficacy of α-cyclodextrin for cholesterol control and that of hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity.
Design, Setting, and Participants


This 6-month double-blind, placebo-controlled, randomized clinical trial, with a 2 × 2 factorial design, was conducted between July 2015 and October 2018 at 2 locations in Sydney, Australia. Eligible participants were aged 18 years or older, had a body mass index (weight in kilograms divided by height in meters squared) of 25 or higher, and had prediabetes within 6 months of study entry according to the American Diabetes Association guidelines. Data analysis was performed from May to August 2019.
Interventions


Participants were randomized to 1 of 4 groups to take active or placebo versions of each supplement (α-cyclodextrin plus hydrolyzed ginseng, α-cyclodextrin plus placebo, placebo plus hydrolyzed ginseng, or placebo plus placebo) for 6 months. All participants received dietetic advice for weight loss.
Main Outcomes and Measures


The primary outcomes were the differences in total cholesterol and fasting plasma glucose between groups after 6 months. The primary analysis used the intention-to-treat principle. Multiple predetermined subsample analyses were conducted.
Results


A total of 401 participants were eligible for the study (248 women [62%]; mean [SD] age, 53.5 [10.2] years; mean [SD] body mass index, 34.6 [6.2]). One hundred one patients were randomized to receive α-cyclodextrin plus hydrolyzed ginseng, 99 were randomized to receive α-cyclodextrin plus placebo, 101 were randomized to receive placebo plus hydrolyzed ginseng, and 100 were randomized to receive placebo plus placebo. For 200 participants taking α-cyclodextrin compared with 201 participants taking placebo, there was no difference in total cholesterol after 6 months (-1.5 mg/dL; 95% CI, -6.6 to 3.5 mg/dL; P = .51). For 202 participants taking hydrolyzed ginseng compared with 199 participants taking placebo, there was no difference in fasting plasma glucose after 6 months (0.0 mg/dL; 95% CI, -1.6 to 1.8 mg/dL; P = .95). Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants; P = .006) and cough (8 participants vs 1 participant; P = .02). Use of hydrolyzed ginseng was associated with rash and pruritus (13 participants vs 2 participants; P = .006). Only 37 of 401 participants (9.2%) experienced these adverse events.
Conclusions and Relevance


Although they are safe for use, there was no benefit found for either α-cyclodextrin for cholesterol control or hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001302640.",2020,Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants; P = .006) and cough (8 participants vs 1 participant; P = .02).,"['A total of 401 participants were eligible for the study (248 women [62%]; mean [SD] age, 53.5 [10.2] years; mean [SD] body mass index, 34.6 [6.2', 'One hundred one patients', 'people with prediabetes and overweight or obesity', '202 participants taking', 'Eligible participants were aged 18 years or older, had a body mass index (weight in kilograms divided by height in meters squared) of 25 or higher, and had prediabetes within 6 months of study entry according to the American Diabetes Association guidelines', 'People With Prediabetes', 'July 2015 and October 2018 at 2 locations in Sydney, Australia']","['α-Cyclodextrin', 'hydrolyzed ginseng', 'placebo\u2009plus\u2009placebo', 'α-cyclodextrin\u2009plus\u2009hydrolyzed ginseng', 'placebo', 'α-cyclodextrin\u2009plus\u2009placebo', 'placebo\u2009plus\u2009hydrolyzed ginseng', 'Hydrolyzed Ginseng Extract', 'dietetic advice', 'α-cyclodextrin', 'placebo versions of each supplement (α-cyclodextrin\u2009plus\u2009hydrolyzed ginseng, α-cyclodextrin\u2009plus\u2009placebo, placebo\u2009plus\u2009hydrolyzed ginseng, or placebo\u2009plus\u2009placebo']","['total cholesterol', 'cough', 'adverse events', 'fasting plasma glucose', 'rash and pruritus', 'total cholesterol and fasting plasma glucose', 'constipation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0010558', 'cui_str': 'Cyclodextrins'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",401.0,0.681302,Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants; P = .006) and cough (8 participants vs 1 participant; P = .02).,"[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Bessell', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Fuller', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Namson S', 'Initials': 'NS', 'LastName': 'Lau', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Burk', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Hendy', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Tegan', 'Initials': 'T', 'LastName': 'Picone', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration, Charles Perkins Centre, The University of Sydney, Sydney, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.23491']
2027,33201245,"Inclusion of a Military-specific, Virtual Reality-based Rehabilitation Intervention Improved Measured Function, but Not Perceived Function, in Individuals with Lower Limb Trauma.","INTRODUCTION


Lower extremity injury is common in the military and can lead to instability, pain, and decreased function. Military service also places high physical demands on service members (SMs). Standard treatment interventions often fail to align with these unique demands. Thus, the goal of the study was to evaluate the effectiveness of a military-specific virtual reality-based rehabilitation (VR) intervention supplemental to standard care (SC) in improving military performance in SMs with lower extremity injuries.
MATERIALS AND METHODS


As part of an institutional review board-approved randomized control trial, SMs receiving care at an advanced rehabilitation center were randomized to receive either SC or VR in addition to SC (VR+SC). Participants were evaluated before treatment and ∼3 weeks later using a previously developed and validated military-specific assessment. Perceived improvement in physical function was measured using a Global Rating of Change (GROC) questionnaire. A repeated measures ANOVA was used to evaluate the effects of adding VR on the military-specific assessment measures. Linear regression was used to determine the relationship between perceived improvement, measured improvement, and VR volume.
RESULTS


The VR+SC group was able to traverse a greater distance in the assessment following the VR intervention. There was no significant difference in GROC between groups. For the VR+SC group, change in distance completed was not correlated with GROC, but GROC was correlated with VR volume.
CONCLUSION


VR improved the distance that participants were able to traverse in the assessment. However, the VR+SC group demonstrated a disconnect between their perceived functional improvement as measured by the GROC and functional improvement as measured by the change in the distance completed. Rather, the perceived improvement appears to be more correlated with the volume of VR received. The way in which the treatment progression is structured and communicated may influence how patients perceive their change in physical function.",2020,"For the VR+SC group, change in distance completed was not correlated with GROC, but GROC was correlated with VR volume.
","['Individuals with Lower Limb Trauma', 'SMs receiving care at an advanced rehabilitation center']","['VR+SC', 'Military-specific, Virtual Reality-based Rehabilitation Intervention', 'military-specific virtual reality-based rehabilitation (VR) intervention supplemental to standard care (SC', 'SC or VR']","['GROC and functional improvement', 'GROC', 'physical function', 'Global Rating of Change (GROC) questionnaire']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0218734,"For the VR+SC group, change in distance completed was not correlated with GROC, but GROC was correlated with VR volume.
","[{'ForeName': 'Riley C', 'Initials': 'RC', 'LastName': 'Sheehan', 'Affiliation': 'Department of Rehabilitation Medicine, Center for the Intrepid, Brooke Army Medical Center, Sam Houston, TX 78234, USA.'}, {'ForeName': 'AuraLea C', 'Initials': 'AC', 'LastName': 'Fain', 'Affiliation': 'Department of Rehabilitation Medicine, Center for the Intrepid, Brooke Army Medical Center, Sam Houston, TX 78234, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Wilson', 'Affiliation': 'Department of Rehabilitation Medicine, Center for the Intrepid, Brooke Army Medical Center, Sam Houston, TX 78234, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wilken', 'Affiliation': 'Department of Rehabilitation Medicine, Center for the Intrepid, Brooke Army Medical Center, Sam Houston, TX 78234, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Rábago', 'Affiliation': 'Department of Rehabilitation Medicine, Center for the Intrepid, Brooke Army Medical Center, Sam Houston, TX 78234, USA.'}]",Military medicine,['10.1093/milmed/usaa483']
2028,33201262,"Cognitive enhancement effects of stimulants: a randomized controlled trial testing methylphenidate, modafinil, and caffeine.","RATIONAL


At all times humans have made attempts to improve their cognitive abilities by different means, among others, with the use of stimulants. Widely available stimulants such as caffeine, but also prescription substances such as methylphenidate and modafinil, are being used by healthy individuals to enhance cognitive performance.
OBJECTIVES


There is a lack of knowledge on the effects of prescription stimulants when taken by healthy individuals (as compared with patients) and especially on the effects of different substances across different cognitive domains.
METHODS


We conducted a pilot study with three arms in which male participants received placebo and one of three stimulants (caffeine, methylphenidate, modafinil) and assessed cognitive performance with a test battery that captures various cognitive domains.
RESULTS


Our study showed some moderate effects of the three stimulants tested. Methylphenidate had positive effects on self-reported fatigue as well as on declarative memory 24 hours after learning; caffeine had a positive effect on sustained attention; there was no significant effect of modafinil in any of the instruments of our test battery. All stimulants were well tolerated, and no trade-off negative effects on other cognitive domains were found.
CONCLUSIONS


The few observed significant positive effects of the tested stimulants were domain-specific and of rather low magnitude. The results can inform the use of stimulants for cognitive enhancement purposes as well as direct further research to investigate the effects of stimulants on specific cognitive domains that seem most promising, possibly by using tasks that are more demanding.",2020,Methylphenidate had positive effects on self-reported fatigue as well as on declarative memory 24 hours after learning; caffeine had a positive effect on sustained attention; there was no significant effect of modafinil in any of the instruments of our test battery.,"['male participants received', 'healthy individuals']","['stimulants (caffeine, methylphenidate, modafinil', 'stimulants', 'methylphenidate and modafinil', 'Methylphenidate', 'placebo', 'methylphenidate, modafinil, and caffeine', 'modafinil']",['sustained attention'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}]",,0.0962187,Methylphenidate had positive effects on self-reported fatigue as well as on declarative memory 24 hours after learning; caffeine had a positive effect on sustained attention; there was no significant effect of modafinil in any of the instruments of our test battery.,"[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Repantis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany. dimitris.repantis@charite.de.'}, {'ForeName': 'Leonore', 'Initials': 'L', 'LastName': 'Bovy', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Ohla', 'Affiliation': 'Institute of Neuroscience and Medicine (INM-3), Jülich Research Centre, Jülich, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Lise Meitner Group for Environmental Neuroscience, Max Planck Institute for Human Development, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dresler', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05691-w']
2029,33201281,Teaching brain imaging through a drawing method may improve learning in medical students.,"OBJECTIVES


Brain imaging is particularly difficult to learn and to teach. This study aimed to evaluate the performance of teaching brain imaging through drawing method in medical faculty students.
METHODS


We conducted a prospective, interventional, randomized, single-blind study in third-year voluntary medical students between December 2016 and June 2019. Eighty medical students received a theoretical training on brain imaging interpretation and were subsequently randomized into two groups (""teaching through drawing"" and ""standard teaching""). An initial evaluation was carried out to assess the students' basic level. Three teaching and training sessions were spread over 2 months in each group. One month after the third teaching session, students were evaluated by an examiner who was blind to the student's group. The same comprehensive evaluation grid has been used for the initial and final students' evaluations to give an objective score out of 20 points. Students' scores were compared between groups using the t test and effect sizes were measured using Cohen's d.
RESULTS


Students' mean age was 21.1 years old. In total, 61.3% were female. Regarding initial evaluation, scores did not differ significantly between both groups (10.1 ± 2.0 versus 9.9 ± 1.9, p = 0.65), thus confirming the homogeneity of the students' basic level. The scores obtained from the final evaluation were significantly higher for the ""teaching through drawing"" students than for the ""standard teaching"" students (14.7 ± 2.7 vs 13.2 ± 2.0, p = 0.009, Cohen's d = 0.62).
CONCLUSIONS


This study provides class II evidence that the method of drawing alone can improve brain imaging comprehension and analysis in medical faculty students.
KEY POINTS


• The method of drawing can improve brain imaging analysis in medical faculty students. • A large majority of students were satisfied by the method of brain imaging teaching through drawing.",2020,"This study provides class II evidence that the method of drawing alone can improve brain imaging comprehension and analysis in medical faculty students.
","['third-year voluntary medical students between December 2016 and June 2019', 'medical faculty students', 'Eighty medical students', 'medical students']",['theoretical training on brain imaging interpretation'],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0015537', 'cui_str': 'Faculties, Medical'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}]",[],,0.0223138,"This study provides class II evidence that the method of drawing alone can improve brain imaging comprehension and analysis in medical faculty students.
","[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Mathon', 'Affiliation': 'Department of Neurosurgery, AP-HP, La Pitié-Salpêtrière - Charles Foix University Hospital, F-75013, Paris, France. bertrand.mathon@aphp.fr.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Chougar', 'Affiliation': 'Sorbonne University, F-75005, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Carpentier', 'Affiliation': 'Department of Neurosurgery, AP-HP, La Pitié-Salpêtrière - Charles Foix University Hospital, F-75013, Paris, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Amelot', 'Affiliation': 'Department of Neurosurgery, AP-HP, La Pitié-Salpêtrière - Charles Foix University Hospital, F-75013, Paris, France.'}]",European radiology,['10.1007/s00330-020-07484-3']
2030,33201346,"Correction to: Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus ® ) and Lantus ®  in healthy subjects: a double-blind, randomized clamp study.",Authors would like to correct the error in table 2 of the online published article.,2020,Authors would like to correct the error in table 2 of the online published article.,['healthy subjects'],['insulin glargine (Glaritus ® '],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]",[],,0.192641,Authors would like to correct the error in table 2 of the online published article.,"[{'ForeName': 'Ashima', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Tawade', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Mushtaque', 'Initials': 'M', 'LastName': 'Mastim', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Eliford Ngaimisi', 'Initials': 'EN', 'LastName': 'Kitabi', 'Affiliation': 'School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Mathangi', 'Initials': 'M', 'LastName': 'Gopalakrishnan', 'Affiliation': 'School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA. mgopalakrishnan@rx.umaryland.edu.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Yeshamaina', 'Affiliation': 'Wockhardt, Global Clinical Development, BKC, Mumbai, India.'}, {'ForeName': 'Joga', 'Initials': 'J', 'LastName': 'Gobburu', 'Affiliation': 'School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Maharaj', 'Initials': 'M', 'LastName': 'Sahib', 'Affiliation': 'Wockhardt, Research Center, Aurangabad, India.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Thakur', 'Affiliation': 'Wockhardt, Research Center, Aurangabad, India.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Prasanna Kumar', 'Affiliation': 'Centre for Diabetes and Endocrine Care, Bengaluru, India.'}]",Acta diabetologica,['10.1007/s00592-020-01617-2']
2031,33201577,Subjective Effects of Alcohol Predict Alcohol Choice in Social Drinkers.,"INTRODUCTION


Alcohol is among the most commonly used psychoactive drugs, yet it can produce markedly different subjective effects in different people. Certain effects, including both heightened stimulatory effects and lesser sedative effects, are thought to predict repeated or excessive use. However, we do not fully understand the nature of these individual differences or their relationships to alcohol consumption. This controlled laboratory study examined subjective and physiologic responses to a moderate dose of alcohol in social drinkers in relation to the subjects' decision to consume alcohol.
METHODS


Healthy adult volunteers (N = 95) participated in a 5-session double-blind alcohol choice study. On the first 4 sessions, they received alcohol (0.8 g/kg) and placebo in alternating order, and on the fifth session, they chose and consumed whichever of the 2 they preferred. During each session, participants completed the Profile of Mood States (POMS) and Biphasic Alcohol Effects Scale (BAES) questionnaires and had their vitals recorded every 30 minutes. We compared subjective and physiologic response to alcohol during the sampling sessions in participants who chose alcohol or placebo on session 5.
RESULTS


Of the 95 participants, 55 chose alcohol (choosers) and 40 chose placebo (nonchoosers). In the full sample, alcohol produced its expected effects (e.g., increased friendliness, elation, and vigor (POMS), and stimulation and sedation (BAES)). The chooser and nonchooser groups did not differ in demographic characteristics, blood alcohol levels, or cardiovascular measures. However, the choosers experienced greater alcohol-induced increases in positive mood (POMS) and liked the drug more, whereas the nonchoosers experienced greater anger, anxiety (POMS), and sedation (BAES) after alcohol.
CONCLUSION


Both greater positive mood effects and lesser sedative effects after alcohol predicted preference under controlled conditions, suggesting that both factors can predict future consumption of alcohol.",2020,"However, the choosers experienced greater alcohol-induced increases in positive mood (POMS) and liked the drug more, whereas the nonchoosers experienced greater anger, anxiety (POMS), and sedation (BAES) after alcohol.
","[""social drinkers in relation to the subjects' decision to consume alcohol"", 'Healthy adult volunteers', 'participants who chose alcohol or placebo on session 5', 'Social Drinkers', '95 participants']","['alcohol', 'placebo', 'Alcohol Predict Alcohol Choice']","['Profile of Mood States (POMS) and Biphasic Alcohol Effects Scale (BAES) questionnaires', 'positive mood (POMS', 'demographic characteristics, blood alcohol levels, or cardiovascular measures', 'friendliness, elation, and vigor (POMS), and stimulation and sedation (BAES', 'sedative effects', 'anger, anxiety (POMS), and sedation (BAES']","[{'cui': 'C0337676', 'cui_str': 'Social drinker'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0542492', 'cui_str': 'Blood ethanol measurement'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0233492', 'cui_str': 'Elation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",95.0,0.0328258,"However, the choosers experienced greater alcohol-induced increases in positive mood (POMS) and liked the drug more, whereas the nonchoosers experienced greater anger, anxiety (POMS), and sedation (BAES) after alcohol.
","[{'ForeName': 'Jingfei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'From the, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, Illinois, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14476']
2032,33190133,Eccentric Cycling Training Improves Health-Related Quality of Life in Adolescents with Obesity.,"INTRODUCTION


While eccentric (ECC) training appears to be more efficient than concentric (CON) training at improving body composition in adolescent with obesity, its impact on health-related quality of life (HRQOL) has never been studied.
OBJECTIVE


The aim of this study is to compare the effects of 2 cycling training modalities, i.e., ECC vs. CON, in adolescents with obesity on HRQOL and health perception (HP).
METHODS


A total of 24 adolescents with obesity, aged 12-16 years, were randomized to either a 12-week ECC or a CON cycling training program performed at the same oxygen consumption (VO2). Anthropometric measurements, body composition, maximal incremental tests, HRQOL (Vécu et Santé Percue de l'Adolescent [VSP-A], Medical Outcome Study Short Form [SF-36]), and HP were assessed at before and after training.
RESULTS AND CONCLUSION


Both CON and ECC cycling trainings promoted significant improvements in BMI, VO2peak, total fat mass, and fat-free mass, with better improvements in body composition parameters in the ECC group (p < 0.05). The VSP-A total score increased after CON (p < 0.01) and ECC (p < 0.001) training, with better enhancement for the ECC group (p < 0.05). The SF-36 physical score increased after both CON (p < 0.01) and ECC (p < 0.001) trainings. The global HP score increased only after ECC training (p < 0.001). Except for the energy-vitality item, no significant correlation was found between changes in HRQOL and its subdomains and anthropometric, body composition, and functional parameters. Both ECC and CON cycling trainings are associated with positive changes in HRQOL and HP. However, ECC seems to induce greater improvements in HRQL and HP than CON cycling training, which is probably not due to the anthropometric, body composition, and functional changes.",2020,The SF-36 physical score increased after both CON (p < 0.01) and ECC (p < 0.001) trainings.,"['adolescents with obesity on HRQOL and health perception (HP', 'Adolescents with Obesity', '24 adolescents with obesity, aged 12-16 years']","['Eccentric Cycling Training', 'ECC or a CON cycling training program performed at the same oxygen consumption (VO2', 'ECC', 'concentric (CON) training', 'ECC vs. CON', 'While eccentric (ECC) training']","['body composition parameters', 'Anthropometric measurements, body composition, maximal incremental tests, HRQOL ', 'HRQOL and its subdomains and anthropometric, body composition, and functional parameters', 'energy-vitality item', 'SF-36 physical score', 'global HP score', 'BMI, VO2peak, total fat mass, and fat-free mass', 'Health-Related Quality of Life', 'VSP', 'HRQL and HP']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",24.0,0.0219115,The SF-36 physical score increased after both CON (p < 0.01) and ECC (p < 0.001) trainings.,"[{'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Julian', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University Teaching Hospital of Clermont-Ferrand, CRNH, INRA, University of Clermont Auvergne, Clermont-Ferrand, France, vjulian@chu-clermontferrand.fr.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Laboratory AME2P, University of Clermont Auvergne, Aubière, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Laboratory AME2P, University of Clermont Auvergne, Aubière, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Department of Biostatistics, University Teaching Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Department of Biostatistics, University Teaching Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Costes', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University Teaching Hospital of Clermont-Ferrand, CRNH, INRA, University of Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University Teaching Hospital of Clermont-Ferrand, CRNH, INRA, University of Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University Teaching Hospital of Clermont-Ferrand, CRNH, INRA, University of Clermont Auvergne, Clermont-Ferrand, France.'}]",Obesity facts,['10.1159/000509961']
2033,33190147,Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.,"Importance


It remains uncertain whether the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) reduce cardiovascular risk.
Objective


To determine the effects on cardiovascular outcomes of a carboxylic acid formulation of EPA and DHA (omega-3 CA) with documented favorable effects on lipid and inflammatory markers in patients with atherogenic dyslipidemia and high cardiovascular risk.
Design, Setting, and Participants


A double-blind, randomized, multicenter trial (enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing omega-3 CA with corn oil in statin-treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C). A total of 13 078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa.
Interventions


Participants were randomized to receive 4 g/d of omega-3 CA (n = 6539) or corn oil, which was intended to serve as an inert comparator (n = 6539), in addition to usual background therapies, including statins.
Main Outcomes and Measures


The primary efficacy measure was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.
Results


When 1384 patients had experienced a primary end point event (of a planned 1600 events), the trial was prematurely halted based on an interim analysis that indicated a low probability of clinical benefit of omega-3 CA vs the corn oil comparator. Among the 13 078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12 633 (96.6%) completed the trial with ascertainment of primary end point status. The primary end point occurred in 785 patients (12.0%) treated with omega-3 CA vs 795 (12.2%) treated with corn oil (hazard ratio, 0.99 [95% CI, 0.90-1.09]; P = .84). A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
Conclusions and Relevance


Among statin-treated patients at high cardiovascular risk, the addition of omega-3 CA, compared with corn oil, to usual background therapies resulted in no significant difference in a composite outcome of major adverse cardiovascular events. These findings do not support use of this omega-3 fatty acid formulation to reduce major adverse cardiovascular events in high-risk patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02104817.",2020,"A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
","['Patients at High Cardiovascular Risk', 'treated participants with high cardiovascular risk, hypertriglyceridemia, and low levels of high-density lipoprotein cholesterol (HDL-C', 'patients with atherogenic dyslipidemia and high cardiovascular risk', 'Among the 13\u202f078 treated patients (mean [SD] age, 62.5 [9.0] years; 35% women; 70% with diabetes; median low-density lipoprotein [LDL] cholesterol level, 75.0 mg/dL; median triglycerides level, 240 mg/dL; median HDL-C level, 36 mg/dL; and median high-sensitivity C-reactive protein level, 2.1 mg/L), 12\u202f633 (96.6%) completed the trial with ascertainment of primary end point status', 'high-risk patients', 'A total of 13\u202f078 patients were randomized at 675 academic and community hospitals in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa', '1384 patients had experienced a primary end point event (of a planned 1600 events', 'enrollment October 30, 2014, to June 14, 2017; study termination January 8, 2020; last patient visit May 14, 2020) comparing']","['omega-3 CA (n\u2009=\u20096539) or corn oil, which was intended to serve as an inert comparator (n\u2009=\u20096539), in addition to usual background therapies, including statins', 'omega-3 fatty acid formulation', 'carboxylic acid formulation of EPA and DHA (omega-3 CA', 'High-Dose Omega-3 Fatty Acids vs Corn Oil', 'omega-3 CA vs the corn oil comparator', 'omega-3 CA', 'omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'omega-3 CA with corn oil in statin']","['composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization', 'composite outcome of major adverse cardiovascular events', 'rate of gastrointestinal adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C4524040', 'cui_str': 'Atherogenic dyslipidaemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0007066', 'cui_str': 'Carboxylic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",13078.0,0.263921,"A greater rate of gastrointestinal adverse events was observed in the omega-3 CA group (24.7%) compared with corn oil-treated patients (14.7%).
","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Victorian Heart Institute, Monash University, Melbourne, Australia.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Garcia', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Bash', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Barter', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Davidson', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Mozaffarian', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': 'Center for Cardiovascular Disease Prevention, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial College of London, London, United Kingdom.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, Maryland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Larrye E', 'Initials': 'LE', 'LastName': 'Loss', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, Maryland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rensfeldt', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Lundström', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Agrawal', 'Affiliation': 'AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA,['10.1001/jama.2020.22258']
2034,33190160,"The impact of a meal, snack, or not eating during the night shift on simulated driving performance post-shift.","Objective The commute home following a night shift is associated with an increased risk for accidents. This study investigated the relationship between food intake during the night shift and simulated driving performance post-shift. Methods Healthy non-shift working males (N=23) and females (N=16), aged 18-39 years (mean 24.5, standard deviation 5.0, years) participated in a seven-day laboratory study and underwent four simulated night shifts. Participants were randomly allocated to one of three conditions: meal at night (N=12; 7 males), snack at night (N=13; 7 males) or no eating at night (N=14; 9 males). During the night shift at 00:30 hours, participants either ate a large meal (meal at night condition), a snack (snack at night condition), or did not eat during the night shift (no eating at night condition). During the second simulated night shift, participants performed a 40-minute York driving simulation at 20:00, 22:30, 01:30, 04:00, and 07:30 hours (similar time to a commute from work). Results The effects of eating condition, drive time, and time-on-task, on driving performance were examined using mixed model analyses. Significant condition×time interactions were found, where at 07:30 hours, those in the meal at night condition displayed significant increases in time spent outside of the safe zone (percentage of time spent outside 10 km/hour of the speed limit and 0.8 meters of the lane center; P<0.05), and greater lane and speed variability (both P<0.01) compared to the snack and no eating conditions. There were no differences between the snack and no eating conditions. Conclusion Driver safety during the simulated commute home is greater following the night shift if a snack, rather than a meal, is consumed during the shift.",2020,There were no differences between the snack and no eating conditions.,"['Methods Healthy non-shift working males (N=23) and females (N=16), aged 18-39 years (mean 24.5, standard deviation 5.0, years) participated in a seven-day laboratory study and underwent four simulated night shifts']",['snack at night (N=13; 7 males) or no eating at night'],"['time spent outside of the safe zone', 'eating condition, drive time, and time-on-task, on driving performance', 'lane and speed variability']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.011342,There were no differences between the snack and no eating conditions.,"[{'ForeName': 'Charlotte C', 'Initials': 'CC', 'LastName': 'Gupta', 'Affiliation': 'Appleton Institute, Central Queensland University, 44 Greenhill Road, Wayville 5034, Adelaide, Australia. c.gupta@cqu.edu.au.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Centofanti', 'Affiliation': ''}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Dorrian', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Coates', 'Affiliation': ''}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Stepien', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kennaway', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': ''}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Heilbronn', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Catcheside', 'Affiliation': ''}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Tuckwell', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Coro', 'Affiliation': ''}, {'ForeName': 'Dilushi', 'Initials': 'D', 'LastName': 'Chandrakumar', 'Affiliation': ''}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3934']
2035,33190178,TRUST: Assessing the Efficacy of an Intervention to Increase HIV Self-Testing Among Young Black Men Who have Sex with Men (MSM) and Transwomen.,"HIV testing among young Black MSM and transwomen (YBMSM/TW) is the gateway to biomedical HIV prevention or treatment. HIV self-testing (HST) is a method that may increase consistent HIV testing. TRUST, a brief, peer-based behavioral intervention, was designed to increase uptake of consistent (every three months) HST among YBMSM/TW in New York City. To test the efficacy of the intervention, we randomized 200 friend pairs into either the intervention condition (TRUST) or a time and attention control condition. A modified intent-to-treat analysis found that self-reported HST at 3-month follow-up was statistically significantly higher (uOR 2.29; 95% CI 1.15, 4.58) and at 6-month follow-up was marginally statistically significantly higher (uOR 1.94; 95% CI 1.00, 3.75) in the intervention arm as compared with the control arm. There were no statistically significant differences by arm at 9- or 12-month follow-up. TRUST, a culturally-congruent intervention to increase HST among YBMSM/TW, had short-term impact on past-three month HST.Clinical Trials Registration ClinicalTrial.gov NCT04210271.",2020,"TRUST, a culturally-congruent intervention to increase HST among YBMSM/TW, had short-term impact on past-three month HST.Clinical Trials Registration ClinicalTrial.gov NCT04210271.","['Who have Sex with Men (MSM) and Transwomen', 'Young Black Men']","['HST', 'TRUST', 'intervention condition (TRUST) or a time and attention control condition', 'HIV self-testing (HST']",[],"[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],200.0,0.0215457,"TRUST, a culturally-congruent intervention to increase HST among YBMSM/TW, had short-term impact on past-three month HST.Clinical Trials Registration ClinicalTrial.gov NCT04210271.","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Frye', 'Affiliation': 'Community Health and Social Medicine, Sophie Davis School of Biomedical Education/CUNY School of Medicine, City College of New York, City University of New York, New York, NY, USA.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Nandi', 'Affiliation': 'Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY, USA.'}, {'ForeName': 'Mark Q', 'Initials': 'MQ', 'LastName': 'Paige', 'Affiliation': 'Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY, USA.'}, {'ForeName': 'Jermaine', 'Initials': 'J', 'LastName': 'McCrossin', 'Affiliation': 'Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lucy', 'Affiliation': 'Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY, USA.'}, {'ForeName': 'Marya', 'Initials': 'M', 'LastName': 'Gwadz', 'Affiliation': 'Silver School of Social Work, New York University, New York, NY, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Donald R', 'Initials': 'DR', 'LastName': 'Hoover', 'Affiliation': 'Department of Statistics and Biostatistics, Rutgers University, The State University of New Jersey, Piscataway, NJ, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Wilton', 'Affiliation': 'Department of Human Development, College of Community and Public Affairs (CCPA), State University of New York At Binghamton, 4400 Vestal Parkway East, Binghamton, NY, 13902, USA. lwilton@binghamton.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-020-03091-x']
2036,33190242,Secondary Aanalysis of a Randomized Clinical Trial of Naltrexone among Women Living with HIV: Correlations between Reductions in Self-Reported Alcohol Use and Changes in Phosphatidylethanol (PEth).,"BACKGROUND


Direct biomarkers such as phosphatidylethanol (PEth) have the capability to detect heavy alcohol use, but it is unclear how strongly self-reported reduction in alcohol use correlates with reduction in PEth. We sought to explore the strength of correlation between reductions in self-reported alcohol use and change in PEth among a sample of women living with HIV (WLWH) who participated in a clinical trial to reduce heavy alcohol use. We also sought to determine whether this correlation was stronger in women with lower body mass index (BMI) and women without an alcohol use disorder (AUD).
METHODS


81 WLWH (mean age=48.7, 80% Black) engaging in a randomized trial of naltrexone versus placebo with a positive baseline PEth (≥8 ng/ml) and alcohol use data at baseline, two and seven months were included in this analysis. Spearman correlation coefficients were compared to measure the correlation between baseline PEth and number of drinks per week by demographic, biological, and alcohol use factors. Mini-International Neuropsychiatric Interview was used to screen for AUD. Further analyses were stratified by BMI and AUD. Spearman correlation coefficients were calculated for the change in PEth and the change in number of drinks per week over seven months, including three time-points: baseline, 2-months, and 7-months.
RESULTS


At baseline, the correlation between baseline PEth and the number of drinks per week was significantly stronger for those with a body mass index (BMI) ≤25 compared to those with a BMI>25 (r=0.66; r=0.26, respectively). Similarly, the correlation between baseline PEth and number of drinks was stronger for those who did not screen positive for AUD compared to those who did (r=0.66; r=0.25, respectively). When stratifying by BMI, a low-to-moderate correlation (r=0.32, p=0.02) was present for persons with a BMI>25; when stratifying by AUD, a moderate correlation (r=0.50, p<.01) was present for persons without an AUD between 0-2 months only.
CONCLUSIONS


In this sample of WLWH, BMI and AUD affected the strength of correlation between PEth and drinks per week. Future work examining changes in PEth over time in broader populations is needed, particularly to understand the differences in PEth due to sex differences.",2020,"Spearman correlation coefficients were calculated for the change in PEth and the change in number of drinks per week over seven months, including three time-points: baseline, 2-months, and 7-months.
RESULTS


At baseline, the correlation between baseline PEth and the number of drinks per week was significantly stronger for those with a body mass index (BMI) ≤25 compared to those with a BMI>25 (r=0.66; r=0.26, respectively).","['women living with HIV (WLWH) who participated in a clinical trial to reduce heavy alcohol use', 'Women Living with HIV', '81 WLWH (mean age=48.7, 80% Black) engaging in a randomized trial of', 'women with lower body mass index (BMI) and women without an alcohol use disorder (AUD']","['Naltrexone', 'naltrexone versus placebo with a positive baseline PEth']",['baseline PEth and number of drinks'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0070787', 'cui_str': 'Phosphatidylethanol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0070787', 'cui_str': 'Phosphatidylethanol'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",,0.0571138,"Spearman correlation coefficients were calculated for the change in PEth and the change in number of drinks per week over seven months, including three time-points: baseline, 2-months, and 7-months.
RESULTS


At baseline, the correlation between baseline PEth and the number of drinks per week was significantly stronger for those with a body mass index (BMI) ≤25 compared to those with a BMI>25 (r=0.66; r=0.26, respectively).","[{'ForeName': 'Veronica L', 'Initials': 'VL', 'LastName': 'Richards', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ruba', 'Initials': 'R', 'LastName': 'Sajdeya', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Villalba', 'Affiliation': 'Robert Stempel College of Public Health & Social Work, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Vaughn', 'Initials': 'V', 'LastName': 'Bryant', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Brumback', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Hahn', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Cook', 'Affiliation': 'Department of Epidemiology, University of Florida, Gainesville, FL, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14515']
2037,33190521,An efficient acute stress response in Chinese individuals with high interdependent self-construal.,"BACKGROUND AND OBJECTIVE


An efficient stress response comprises both quick reactivity and rapid recovery. Studies have found an enhanced stress response in Chinese people with high interdependent self-construal (ISC). ISC is a personality trait that is well-matched with Chinese collectivistic culture, and whether they exhibit an efficient stress response has not been exclusively examined.
DESIGN


We conducted a novel experiment to examine the stress response change rate in Chinese participants with varying levels of ISC，then performed a validation analysis against previous data to examine the reliability of current results.
METHODS


In our experiment, 84 healthy (42 high-ISC and 42 low-ISC), young, native Chinese were randomly assigned to either the Trier Social Stress Test (TSST), or the control condition. In the published study, 46 native Chinese participants (23 high-ISC and 23 low-ISC) had undergone the TSST. Data were collected throughout the two experiments.
RESULTS


Compared to low-ISC participants, cortisol and subjective stress levels in high-ISC participants peaked sooner and declined rapidly, suggesting quick stress reactivity and rapid recovery. This finding was supported by the previous study.
CONCLUSIONS


High-ISC individuals display an efficient stress response pattern, manifested by fast reactivity and rapid recovery, which may be adaptive in Chinese collectivistic culture.",2020,"Compared to low-ISC participants, cortisol and subjective stress levels in high-ISC participants peaked sooner and declined rapidly, suggesting quick stress reactivity and rapid recovery.","['Chinese people with high interdependent self-construal (ISC', 'Chinese individuals with high interdependent self-construal', '46 native Chinese participants (23 high-ISC and 23 low-ISC) had undergone the TSST', '84 healthy (42 high-ISC and 42 low-ISC), young, native Chinese', 'Chinese participants with varying levels of ISC，then']","['ISC', 'Trier Social Stress Test (TSST']",['cortisol and subjective stress levels'],"[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",46.0,0.0446129,"Compared to low-ISC participants, cortisol and subjective stress levels in high-ISC participants peaked sooner and declined rapidly, suggesting quick stress reactivity and rapid recovery.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Faculty of Psychology, Southwest University, Chongqing, People's Republic of China.""}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1846724']
2038,33190559,Dietary Approaches to Stop Hypertension Dietary Intervention Improves Blood Pressure and Vascular Health in Youth With Elevated Blood Pressure.,"This randomized control trial assessed the post-intervention and 18-month follow-up effects of a 6-month dietary approaches to stop hypertension (DASH)-focused behavioral nutrition intervention, initiated in clinic with subsequent telephone and mail contact, on blood pressure (BP) and endothelial function in adolescents with elevated BP. Adolescents (n=159) 11 to 18 years of age with newly diagnosed elevated BP or stage 1 hypertension treated at a hospital-based clinic were randomized. DASH participants received a take-home manual plus 2 face-to-face counseling sessions at baseline and 3 months with a dietitian regarding the DASH diet, 6 monthly mailings, and 8 weekly and then 7 biweekly telephone calls focused on behavioral strategies to promote DASH adherence. Routine care participants received nutrition counseling with a dietitian consistent with pediatric guidelines established by the National High Blood Pressure Education Program. Outcomes, measured pre- and post-intervention and at 18-months follow-up, included change in BP, change in brachial artery flow-mediated dilation, and change in DASH score based on 3-day diet recalls. Adolescents in DASH versus routine care had a greater improvement in systolic BP (-2.7 mm Hg,  P = 0.03, -0.3 z-score,  P =0.03), flow-mediated dilation (2.5%,  P =0.05), and DASH score (13.3 points,  P <0.0001) from baseline to post-treatment and a greater improvement in flow-mediated dilation (3.1%,  P =0.03) and DASH score (7.4 points,  P =0.01) to 18 months. The DASH intervention proved more effective than routine care in initial systolic BP improvement and longer term improvement in endothelial function and diet quality in adolescents with elevated BP and hypertension. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00585832.",2020,The DASH intervention proved more effective than routine care in initial systolic BP improvement and longer term improvement in endothelial function and diet quality in adolescents with elevated BP and hypertension.,"['adolescents with elevated BP and hypertension', 'Adolescents (n=159) 11 to 18 years of age with newly diagnosed elevated BP or stage 1 hypertension treated at a hospital-based clinic were randomized', 'adolescents with elevated BP', 'Youth With Elevated Blood Pressure']","['6-month dietary approaches to stop hypertension (DASH)-focused behavioral nutrition intervention', 'Stop Hypertension Dietary Intervention', 'DASH intervention', 'take-home manual plus 2 face-to-face counseling sessions at baseline and 3 months with a dietitian regarding the DASH diet', 'nutrition counseling with a dietitian consistent with pediatric guidelines established by the National High Blood Pressure Education Program']","['systolic BP', 'flow-mediated dilation', 'initial systolic BP improvement', 'endothelial function and diet quality', 'Blood Pressure and Vascular Health', 'blood pressure (BP) and endothelial function', 'DASH score', 'change in BP, change in brachial artery flow-mediated dilation, and change in DASH score based on 3-day diet recalls']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0621583,The DASH intervention proved more effective than routine care in initial systolic BP improvement and longer term improvement in endothelial function and diet quality in adolescents with elevated BP and hypertension.,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Couch', 'Affiliation': 'From the Department of Rehabilitation, Exercise and Nutrition Sciences, University of Cincinnati (S.C.C.).'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Saelens', 'Affiliation': ""Department of Pediatrics, University of Washington Seattle Children's Research Institute (B.E.S.).""}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Khoury', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center (P.R.K., M. M. M., E.M.U.).""}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dart', 'Affiliation': 'Department of Nutrition, Northside Hospital, Atlanta, GA (K.B.D.).'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Hinn', 'Affiliation': 'Department of Nutrition, VA Medical Center, Richmond (K.H.).'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Mitsnefes', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center (P.R.K., M. M. M., E.M.U.).""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Daniels', 'Affiliation': 'Department of Pediatrics, University of Colorado School of Medicine, Denver (S.R.D.).'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center (P.R.K., M. M. M., E.M.U.).""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.16156']
2039,33190575,Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial.,"OBJECTIVES


The aim of this research was to evaluate the effects of adding 10 g of cocoa-rich chocolate (99%) to the habitual diet on cognitive performance in postmenopausal women.
METHODS


Following a randomised controlled parallel clinical trial, a total of 140 postmenopausal women aged 50-64 were recruited. The intervention group ( n  = 73) consumed daily 10 g of chocolate (99% cocoa) in addition to their usual food intake for 6 months, whereas the control group ( n  = 67) did not receive any intervention. Attention and executive functions, verbal memory, working memory, phonological fluency, category fluency and clinical variables were assessed at baseline and 6 months.
RESULTS


Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18;  p  = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's  d  = -0.343). Attention, immediate or delayed verbal memory, phonological or category fluency, and working memory remained unchanged.
CONCLUSIONS


The consumption of cocoa-rich (99%) chocolate in addition to the habitual diet could be related to a slight improvement in cognitive performance regarding cognitive flexibility and processing speed in postmenopausal women, with no changes in the rest of the cognitive performance variables evaluated. Trial registration:  This clinical trial has been registered at clinicaltrials.gov as NCT03492983.",2020,"RESULTS


Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18;  p  = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's  d  = -0.343).","['140 postmenopausal women aged 50-64 were recruited', 'postmenopausal women']","['cocoa-rich chocolate', 'habitual diet', 'intervention group ( n \u2009=\u200973) consumed daily 10\u2005g of chocolate (99% cocoa) in addition to their usual food intake for 6 months, whereas the control group ( n \u2009=\u200967) did not receive any intervention']","['Attention, immediate or delayed verbal memory, phonological or category fluency, and working memory remained unchanged', 'cognitive performance', 'Trail Making Test B execution time', 'Attention and executive functions, verbal memory, working memory, phonological fluency, category fluency and clinical variables']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0589137', 'cui_str': 'Delayed verbal memory'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0442739', 'cui_str': 'No status change'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",140.0,0.234078,"RESULTS


Trail Making Test B execution time showed a decreased of -12.08 s (95% CI: -23.99, -0.18;  p  = 0.047) in the intervention group compared to the control group, after adjusting for age, educational level, time elapsed from the beginning of menopause and daily energy consumption (Cohen's  d  = -0.343).","[{'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Garcia-Yu', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gomez-Marcos', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mora-Simon', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maderuelo-Fernandez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Recio-Rodriguez', 'Affiliation': 'Instituto de Investigación Biomédica de Salamanca (IBSAL), Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Servicio de Salud de Castilla y León (SACyL), Salamanca, Spain.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1840119']
2040,33190607,The immediate effect of the abdominal drawing-in maneuver technique on stature change in seated sedentary workers with chronic low back pain.,"Many studies have measured stature change arising from loads imposed on the spine during sitting. To improve stature recovery, it is important to stabilise the lumbar spine and compensate forces from the upper body. The abdominal drawing-in maneuver (ADIM) technique has been found to mainly activate deep trunk muscles. The purpose of this study was to determine whether activation of deep trunk muscles by the ADIM technique could immediately improve stature recovery during prolonged sitting. Twenty-four patients with chronic low back pain (CLBP) were randomly allocated into different orders of experimental conditions: control (sitting without ADIM technique) and intervention conditions (sitting with ADIM technique). The latter condition required participants to complete ADIM technique for 1 min and repeat it three times throughout 41 min prolonged sitting time. Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition ( p -value = 0.001). Our finding demonstrated that ADIM technique improved stature recovery.  Practitioner Summary:  Prolonged sitting seemingly harms sedentary workers' health, particularly affecting the lower back. Activation of deep trunk muscles using abdominal drawing-in maneuver technique can promote spinal recovery. Clinicians can teach abdominal drawing-in maneuver technique to activate deep trunk muscles in chronic low back pain, thereby promoting self-management of seated stature recovery.  Abbrevations:  ADIM: abdominal drawing-in maneuver; RA: rectus abdominis; ICLT: iliocostalis lumborum pars thoracis; LM: lumbar multifidus; TrA: transversus abdominis; IO: internal oblique; CLBP: chronic low back pain; LBP: low back pain; RMDQ: Roland Morris disability questionnaire; NRS: numerical rating scale.",2020,Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition ( p -value = 0.001).,"['seated sedentary workers with chronic low back pain', 'Twenty-four patients with chronic low back pain (CLBP']","['experimental conditions: control (sitting without ADIM technique) and intervention conditions (sitting with ADIM technique', 'abdominal drawing-in maneuver\xa0technique']","['stature recovery', 'Stature recovery']","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}]",24.0,0.0134712,Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition ( p -value = 0.001).,"[{'ForeName': 'Pongsatorn', 'Initials': 'P', 'LastName': 'Saiklang', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Rungthip', 'Initials': 'R', 'LastName': 'Puntumetakul', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Manida', 'Initials': 'M', 'LastName': 'Swangnetr Neubert', 'Affiliation': 'Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Boucaut', 'Affiliation': 'International Centre for Allied Health Evidence, University of South Australia, Adelaide, Australia.'}]",Ergonomics,['10.1080/00140139.2020.1810326_1']
2041,33190615,Telerehabilitation After Stroke Using Readily Available Technology: A Randomized Controlled Trial.,"BACKGROUND


The number of people living with stroke has increased demand for rehabilitation. A potential solution is telerehabilitation for health care delivery to promote self-management. One such approach is the Augmented Community Telerehabilitation Intervention (ACTIV). This structured 6-month program uses limited face-to-face sessions, telephone contact, and text messages to augment stroke rehabilitation.
OBJECTIVE


To investigate whether ACTIV improved physical function compared with usual care.
METHODS


This 2-arm, parallel randomized controlled trial was conducted in 4 New Zealand centers. Inclusion criteria were patients with first-ever stroke, age >20 years, and discharged home. A blinded assessor completed outcome measurement in participants' homes at baseline, postintervention, and 6 months postintervention. Stratified block randomization occurred after baseline assessment, with participants allocated to ACTIV or usual care control.
RESULTS


A total of 95 people were recruited (ACTIV: n = 47; control: n = 48). Postintervention intention-to-treat analysis found a nonsignificant difference between the groups in scores (4·51;  P  = .07) for physical function (measured by the physical subcomponent of the Stroke Impact Scale). The planned per-protocol analysis (ACTIV: n = 43; control: n = 48) found a significant difference in physical function between the groups (5·28;  P  = .04). Improvements in physical function were not maintained at the 12-month follow-up.
CONCLUSIONS


ACTIV was not effective in improving physical function in the ACTIV group compared with the usual care group. The per-protocol analysis raises the possibility that for those who receive more than 50% of the intervention, ACTIV may be effective in preventing deterioration or even improving physical function in people with stroke, in the period immediately following discharge from hospital.",2020,"Improvements in physical function were not maintained at the 12-month follow-up.
","['A total of 95 people were recruited (ACTIV: n = 47; control: n = 48', '4 New Zealand centers', 'Inclusion criteria were patients with first-ever stroke, age >20 years, and discharged home']",['Telerehabilitation'],['physical function'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",95.0,0.108384,"Improvements in physical function were not maintained at the 12-month follow-up.
","[{'ForeName': 'Nicola L', 'Initials': 'NL', 'LastName': 'Saywell', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain C', 'Initials': 'AC', 'LastName': 'Vandal', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Mudge', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Hale', 'Affiliation': 'University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'University of California, Merced, CA, USA.'}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Feigin', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Hanger', 'Affiliation': 'Canterbury District Health Board, Christchurch, Canterbury, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320971765']
2042,33191060,A decision aid to facilitate informed choices among cataract patients: A randomized controlled trial.,"OBJECTIVE


To assess the effect of a patient decision aid on the quality of decision-making for patients with age-related cataracts.
METHODS


773 patients with cataracts aged 50-80 years were randomly assigned to receive either the intervention decision aid (including standard information, quantitative information on the possible outcomes of cataract surgery and a value clarification exercise) or the control booklet (including standard information). The primary outcome was informed choice (defined as adequate knowledge and congruency between attitudes and surgical intentions), which was assessed at 2 weeks after intervention via a telephone interview.
RESULTS


The decision aid increased the proportion of participants making an informed choice, from 5.68 % in the control group to 27.7 % in the intervention group (P < 0.001). Compared with controls, more participants in the intervention group had adequate overall knowledge about cataract surgery (36.8 % vs. 8.79 % in controls; P < 0.001), and fewer participants intended to undergo surgery (22.5 % vs. 34.1 % in controls; P < 0.001).
CONCLUSION


Use of the patient decision aid may increase the proportion of patients making informed choices. Importantly, it might also reduce the acceptance of operations.
PRACTICE IMPLICATIONS


Patient decision aids represent a simple and low-cost tool to facilitate informed choice among patients with cataracts.",2020,"The decision aid increased the proportion of participants making an informed choice, from 5.68 % in the control group to 27.7 % in the intervention group (P < 0.001).","['cataract patients', 'patients with cataracts', 'patients with age-related cataracts', '773 patients with cataracts aged 50-80 years']","['intervention decision aid (including standard information, quantitative information on the possible outcomes of cataract surgery and a value clarification exercise) or the control booklet (including standard information']","['adequate overall knowledge about cataract surgery', 'adequate knowledge and congruency between attitudes and surgical intentions']","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0150401', 'cui_str': 'Values clarification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",773.0,0.136738,"The decision aid increased the proportion of participants making an informed choice, from 5.68 % in the control group to 27.7 % in the intervention group (P < 0.001).","[{'ForeName': 'Guofang', 'Initials': 'G', 'LastName': 'Ye', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yih-Chung', 'Initials': 'YC', 'LastName': 'Tham', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ecosse', 'Initials': 'E', 'LastName': 'Lamoureux', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China; Singapore Eye Research Institute, Singapore National Eye Centre, Singapore, Singapore.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Congdon', 'Affiliation': ""State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China; Centre for Public Health, Queen's University Belfast, Belfast, Ireland. Electronic address: ncongdon1@gmail.com.""}, {'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. Electronic address: zhyfeng@mail.sysu.edu.cn.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. Electronic address: liuyizh@mail.sysu.edu.cn.'}]",Patient education and counseling,['10.1016/j.pec.2020.10.036']
2043,33191061,"Comparison of Effectiveness of Density and Number of Sessions of Extracorporeal Shock Wave Therapy in Plantar Fasciitis Patients: A Double-Blind, Randomized-Controlled Study.","This study aims to investigate the effect of density and number of sessions extracorporeal shock wave therapy (ESWT) on pain, fatigue, disability, physical function, and quality of life in patients with plantar fasciitis (PF). Between September 2019 and December 2019, a total of 94 patients with the diagnosis of PF were included in the study. All patients were randomly divided into 3 groups. Group 1 (n = 33) received a total of 7 sessions of high-energy flux density (H-ESWT) (0.26 mJ/mm 2  ) , group 2 (n = 31) received a total of 3 sessions of H-ESWT (0.26 mJ/mm 2 ), group 3 (n = 30) received total of 7 sessions of low-energy flux density (<0.08 mJ/mm 2 ) with 3 days interval. At baseline and 1 month after the treatment, the Visual Analog Scale (VAS), Short Form-36, Foot Function Index (FFI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, and Six-Minute Walking Test (6MWT) scores were compared among the groups. Of the patients, 69 were females and 25 were males with a mean age of 45.0 ± 8.43 (range, 25-67) years. There were no statistically significant differences in the age, sex, demographic characteristics, and baseline VAS, FFI, 6MWT, and FACIT scores between the groups (p > .05). However, there was a statistically significant decrease in the VAS, FACIT, and FFI scores in all groups after treatment compared to baseline, although only the 6MWT, and Short Form-36 subscale scores were statistically significantly higher (p < .05). There was also a statistically significant difference in the scale scores in Group 1 versus Group 2 and in Group 2 versus Group 3. Our study results suggest that H-ESWT for high number of sessions is more effective than LESWT for low number of sessions on pain, quality of life, physical function, fatigue, and disability in patients with PF.",2020,"However, there was a statistically significant decrease in the VAS, FACIT, and FFI scores in all groups after treatment compared to baseline, although only the 6MWT, and Short Form-36 subscale scores were statistically significantly higher (p < .05).","['patients with PF', 'Plantar Fasciitis Patients', 'Of the patients, 69 were females and 25 were males with a mean age of 45.0 ± 8.43 (range, 25-67) years', 'Between September 2019 and December 2019, a total of 94 patients with the diagnosis of PF were included in the study', 'patients with plantar fasciitis (PF']","['Density and Number of Sessions of Extracorporeal Shock Wave Therapy', 'H-ESWT', 'sessions extracorporeal shock wave therapy (ESWT', 'LESWT']","['pain, fatigue, disability, physical function, and quality of life', '6MWT, and Short Form-36 subscale scores', 'pain, quality of life, physical function, fatigue, and disability', '6MWT) scores', 'VAS, FACIT, and FFI scores', 'age, sex, demographic characteristics, and baseline VAS, FFI, 6MWT, and FACIT scores', 'Visual Analog Scale (VAS), Short Form-36, Foot Function Index (FFI), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale, and Six-Minute Walking Test', 'scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0206042', 'cui_str': 'Fatal familial insomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",94.0,0.0389034,"However, there was a statistically significant decrease in the VAS, FACIT, and FFI scores in all groups after treatment compared to baseline, although only the 6MWT, and Short Form-36 subscale scores were statistically significantly higher (p < .05).","[{'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Gezginaslan', 'Affiliation': 'Medical Doctor, Physical Therapy and Rehabilitation Clinic, University of Health Sciences, Umraniye Training and Research Hospital, Istanbul, Turkey. Electronic address: omergezginaslan@hotmail.com.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Başar', 'Affiliation': 'Medical Doctor, Physical Therapy and Rehabilitation Clinic, University of Health Sciences, Umraniye Training and Research Hospital, Istanbul, Turkey.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2020.08.001']
2044,33191117,The role of multiparametric MRI in active surveillance for low-risk prostate cancer: The ROMAS randomized controlled trial.,"BACKGROUND


We aim to evaluate the impact of multiparametric magnetic resonance imaging and fusion-target biopsy for early reclassification of patients with low-risk Prostate Cancer in a randomized trial.
MATERIALS AND METHODS


Between 2015 and 2018, patients diagnosed with Prostate Cancer after random biopsy fulfilling PRIAS criteria were enrolled and centrally randomized (1:1 ratio) to study group or control group. Patients randomized to study group underwent multiparametric magnetic resonance imaging at 3 months from enrollment: patients with positive findings (PIRADS-v2>2) underwent fusion-target biopsy; patients with negative multiparametric magnetic resonance imaging or confirmed ISUP - Grade Group 1 at fusion-target biopsy were managed according to PRIAS schedule and 12-core random biopsy was performed at 12 months. Patients in control group underwent PRIAS protocol, including a confirmatory 12-core random biopsy at 12 months. Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls. Reclassification was defined as biopsy ISUP Grade Group 1 in >2 biopsy cores or disease upgrading.
RESULTS


A total of 124 patients were randomized to study group (n = 62) or control group (n = 62). Around 21 of 62 patients (34%) in study group had a positive multiparametric magnetic resonance imaging, and underwent fusion-target biopsy, with 11 (17.7%) reclassifications. Considering the intention-to-treat population, reclassification rate at 12-month random biopsy was 6.5% for study group and 29% for control group, respectively (P < 0.001).
CONCLUSIONS


The early employment of multiparametric magnetic resonance imaging for active surveillance patients enrolled after random biopsy consents to significantly reduce reclassifications at 12-month random biopsy.",2020,Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls.,"['Between 2015 and 2018, patients diagnosed with Prostate Cancer after random biopsy fulfilling PRIAS criteria', 'patients with positive findings (PIRADS-v2>2) underwent fusion-target biopsy; patients with', 'low-risk prostate cancer', '124 patients', 'patients with low-risk Prostate Cancer']","['multiparametric MRI', 'negative multiparametric magnetic resonance imaging or confirmed ISUP - Grade Group 1 at fusion-target biopsy were managed according to PRIAS schedule and 12-core random biopsy', 'multiparametric magnetic resonance imaging', 'multiparametric magnetic resonance imaging and fusion-target biopsy']","['reduction of reclassification rate', 'positive multiparametric magnetic resonance imaging']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332326', 'cui_str': 'Gleason grading system for prostatic cancer'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}]",124.0,0.169567,Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls.,"[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Schiavina', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Droghetti', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy. Electronic address: droghet@gmail.com.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Novara', 'Affiliation': 'Department of Surgery, Oncology, and Gastroenterology - Urology Clinic University of Padua, Padua, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Gaudiano', 'Affiliation': 'Department of Radiology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Panebianco', 'Affiliation': 'Department of Radiology, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Borghesi', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Piazza', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mineo Bianchi', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guerra', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Beniamino', 'Initials': 'B', 'LastName': 'Corcioni', 'Affiliation': 'Department of Radiology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Michelangelo', 'Initials': 'M', 'LastName': 'Fiorentino', 'Affiliation': 'Department of Pathology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Giunchi', 'Affiliation': 'Department of Pathology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Verze', 'Affiliation': 'Department of Medicine, Surgery, Dentistry ""Scuola Medica Salernitana"", University of Salerno, Salerno, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Pultrone', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Golfieri', 'Affiliation': 'Department of Radiology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Porreca', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mirone', 'Affiliation': 'Department of Urology, University of Naples, Federico II, Naples, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Brunocilla', 'Affiliation': 'Department of Urology, S.Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.'}]",Urologic oncology,['10.1016/j.urolonc.2020.10.018']
2045,33191157,Effect of medication reconciliation on patient reported potential adverse events after hospital discharge.,"BACKGROUND


Although medication reconciliation (MedRec) is effective in decreasing medication discrepancies, the effectiveness on Adverse Events (AEs) is very scarce. The objective of this study was to assess the effect of MedRec by a pharmacy team on patient-reported, potential AEs post-discharge.
METHODS


This was a multicenter prospective intervention study with before-after design at two Dutch hospitals. Participants were patients aged ≥18 years admitted for more than 48 h using three or more prescription medications upon discharge. Patients in the control group received usual care. In the intervention period, a trained team of pharmacy staff executed medication reconciliation consisting of patient education upon admission and discharge, review of prescribed medication to identify errors, and information transfer to primary care. To address the primary outcome, the difference in proportion of patients with one or more potential AEs was measured by a structured telephone interview, two weeks after discharge between usual care and intervention group. To address the second outcome, the difference in median number of potential AEs per patient was calculated. Other outcomes assessed included the association between the intervention and patient characteristics.
RESULTS


In total, 221 (138 usual care and 83 intervention) patients were included. The proportion of control and intervention patients with AEs was 88.4% and 86.7% respectively (p > 0.05). The median number of potential AEs per patient was lower in the intervention group compared with usual care (1.1 vs. 2.1, p < 0.0001). Being in the intervention arm was associated with less potential AEs (RR 0.5, 95% CI [0.4-0.6]), whereas being previously admitted was associated with a higher number of potential AEs (RR 1.3, 95% CI [1.1-1.5]). The effect of the intervention on the number of potential AE was stronger among women compared with men (p = 0.04).
CONCLUSION


Although the intervention did not decrease the proportion of patients with AEs, a significant reduction in the median number of potential AEs after hospital discharge between the intervention and usual care group was observed.",2020,"Although the intervention did not decrease the proportion of patients with AEs, a significant reduction in the median number of potential AEs after hospital discharge between the intervention and usual care group was observed.","['Participants were patients aged ≥18 years admitted for more than 48\xa0h using three or more prescription medications upon discharge', 'patient reported potential adverse events after hospital discharge', 'In total, 221 (138 usual care and 83 intervention) patients were included']",['usual care'],"['median number of potential AEs', 'potential AEs', 'median number of potential AEs per patient', 'number of potential AEs', 'median number of potential AEs after hospital discharge', 'number of potential AE', 'proportion of patients with one or more potential AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",221.0,0.0938469,"Although the intervention did not decrease the proportion of patients with AEs, a significant reduction in the median number of potential AEs after hospital discharge between the intervention and usual care group was observed.","[{'ForeName': 'C C M', 'Initials': 'CCM', 'LastName': 'Stuijt', 'Affiliation': 'ApoMed Amsterdam, the Netherlands. Electronic address: stuijt@apomed.nl.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Bekker', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Pharmacy, Nijmegen, the Netherlands.'}, {'ForeName': 'B J F', 'Initials': 'BJF', 'LastName': 'van den Bemt', 'Affiliation': 'Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Pharmacy, Nijmegen, the Netherlands; Department of Pharmacy, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Karapinar', 'Affiliation': 'Department of Clinical Pharmacy, OLVG Hospital, Amsterdam, the Netherlands. Electronic address: f.karapinar@olvg.nl.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.10.012']
2046,33196302,Using contact-based education to destigmatize opioid use disorder among medical students.,"CONTEXT


All first- and second-year (i.e., pre-clinical) medical students at a large, Midwestern medical school with three campuses were invited to participate in a two-arm, parallel educational study comparing the efficacy of two types of curricular interventions. Students at the main campus attended the modified contact-based education panel or the didactic lecture in person, while students at the two distance campuses attended the modified contact-based education or lecture remotely using the University's videoconferencing system.  Impact:  A total of 109 students participated in the study (average age 24.2 years ( SD  = 2.6), 64.2% female, 79.8% white, 56.0% second-year students, 67.9% attended on main campus, lecture = 52 participants, modified contact-based = 57 participants). Baseline responses were similar across groups. Following the session, participants in both interventions rated drug abuse (percent increase = 21.2%,  p  < .001) and prescription drug diversion (percent increase = 7.6%,  p  = .004) as more serious problems. Participants from both interventions expressed increased confidence in caring for patients with OUD (percent increase = 45.5%,  p  < .001) and increased interest in pursuing MAT training (percent increase = 21.5%,  p  = .04). Both curricular interventions were equally effective at reducing OUD stigma with a significant 8.2% decrease in total stigma scores and a large effect size ( p  < .001, η p   2  = .34). Lastly, participants with lower post-assessment OUD stigma scores were more likely to indicate that they would pursue additional training to provide MAT ( p  = .02).  Lessons learned:  Exposure to opioid-specific education with a focus on MAT and recovery, regardless of education type, positively affected opioid-related postgraduate intentions and reduced OUD stigma. Notably, these findings suggest that there are multiple efficacious techniques to reduce OUD stigma during preclinical training.",2020,"Following the session, participants in both interventions rated drug abuse (percent increase = 21.2%,  p  < .001) and prescription drug diversion (percent increase = 7.6%,  ","['i.e., pre-clinical) medical students at a large, Midwestern medical school with three campuses', ""Students at the main campus attended the modified contact-based education panel or the didactic lecture in person, while students at the two distance campuses attended the modified contact-based education or lecture remotely using the University's videoconferencing system"", '109 students participated in the study (average age 24.2\u2009years ( SD \u2009=\u20092.6), 64.2% female, 79.8% white, 56.0% second-year students, 67.9% attended on main campus, lecture = 52 participants, modified contact-based = 57 participants', 'medical students']",[],"['serious problems', 'prescription drug diversion', 'OUD stigma', 'confidence in caring', 'total stigma scores', 'OUD stigma scores', 'interest in pursuing MAT training']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",[],"[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3658253', 'cui_str': 'Controlled Substance Diversion'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",109.0,0.0379617,"Following the session, participants in both interventions rated drug abuse (percent increase = 21.2%,  p  < .001) and prescription drug diversion (percent increase = 7.6%,  ","[{'ForeName': 'Sophia C', 'Initials': 'SC', 'LastName': 'Mort', 'Affiliation': 'Department of Medicine, Ohio University Heritage College of Osteopathic Medicine, Athens, Ohio, USA.'}, {'ForeName': 'Sebastián R', 'Initials': 'SR', 'LastName': 'Díaz', 'Affiliation': ""Dean's Office of Medical Education, Northeast Ohio Medical University College of Medicine, Rootstown, Ohio, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Beverly', 'Affiliation': 'Department of Primary Care, Ohio University Heritage College of Osteopathic Medicine, Athens, Ohio, USA.'}]",Teaching and learning in medicine,['10.1080/10401334.2020.1820869']
2047,33196306,"Response by Schwartz et al to Letter Regarding Article, ""Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial"".",,2020,,[],['Alirocumab'],['Peripheral Artery Disease and Venous Thromboembolic Events'],[],"[{'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.0795364,,"[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'University of Colorado School of Medicine, Aurora (G.S.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'CPC Clinical Research and University of Colorado School of Medicine, Aurora, CO (M.S.).'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'University of Alabama at Birmingham (V.B.).'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Hôpital Bichat, and Institut National de la Santé et de la Recherche Médicale, Unit 1148, France (P.G.S.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050609']
2048,33196313,"Letter by Packard Regarding Article, ""Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial"".",,2020,,[],['Alirocumab'],['Peripheral Artery Disease and Venous Thromboembolic Events'],[],"[{'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",,0.108739,,"[{'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Packard', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050070']
2049,33196410,An intervention to improve the quality of life in children of parents with serious mental illness: the Young SMILES feasibility RCT.,"BACKGROUND


Quality of life for children and adolescents living with serious parental mental illness can be impaired, but evidence-based interventions to improve it are scarce.
OBJECTIVE


Co-production of a child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES)] to improve the health-related quality of life of children and adolescents living with serious parental mental illness, and evaluating its acceptability and feasibility for delivery in NHS and community settings.
DESIGN


Qualitative and co-production methods informed the development of the intervention (Phase I). A feasibility randomised controlled trial was designed to compare Young SMILES with treatment as usual (Phase II). Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents. A mixture of semistructured qualitative interviews and focus group research was used to examine feasibility among Young SMILES facilitators and referrers/non-referrers.
SETTING


Randomisation was conducted after baseline measures were collected by the study co-ordinator, ensuring that the blinding of the statistician and research team was maintained to reduce detection bias.
PARTICIPANTS


Phase I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors. Phase II: 40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators.
INTERVENTION


Young SMILES was delivered at two sites: (1) Warrington, supported by the National Society for the Prevention of Cruelty to Children (NSPCC), and (2) Newcastle, supported by the NHS and Barnardo's. An eight-session weekly group programme was delivered, with four to six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years). At week 4, a five-session parallel weekly programme was offered to the parents/carers. Sessions lasted 2 hours each and focused on improving mental health literacy, child-parent communication and children's problem-solving skills.
MAIN OUTCOME MEASURES


Phase ll children and parents completed questionnaires at randomisation and then again at 4 and 6 months post randomisation. Quality of life was self-reported by children and proxy-reported by parents using the Paediatric Quality of Life questionnaire and KIDSCREEN. Semistructured interviews with parents ( n  = 14) and children ( n  = 17) who participated in the Young SMILES groups gathered information about their motivation to sign up to the study, their experiences of participating in the group sessions, and their perceived changes in themselves and their family members following intervention. Further interviews with individual referrers ( n  = 5) gathered information about challenges to recruitment and randomisation. Two focus groups ( n  = 16) with practitioners who facilitated the intervention explored their views of the format and content of the Young SMILES manual and their suggestions for changes.
RESULTS


A total of 35 families were recruited: 20 were randomly allocated to Young SMILES group and 15 to treatment as usual. Of those, 28 families [15/20 (75%) in the intervention group and 13/15 (87%) in the control group] gave follow-up data at the primary end point (4 months post baseline). Participating children had high adherence to the intervention and high completion rates of the questionnaires. Children and adolescents living with their parents, who had serious mental illness, and their parents were mainly very positive and enthusiastic about Young SMILES, both of whom invoked the benefits of peer support and insight into parental difficulties. Although facilitators regarded Young SMILES as a meaningful and distinctive intervention having great potential, referrers identified several barriers to referring families to the study. One harm was reported by a parent, which was dealt with by the research team and the NSPCC in accordance with the standard operating procedures.
LIMITATIONS


The findings from our feasibility study are not sufficient to recommend a fully powered trial of Young SMILES in the near future. Although it was feasible to randomise children and adolescents living with serious parental mental illness of different ages to standardised, time-limited groups in both NHS and non-NHS settings, an intervention like Young SMILES is unlikely to address underlying core components of the vulnerability that children and adolescents living with serious parental mental illness express as a population over time.
CONCLUSIONS


Young SMILES was widely valued as unique in filling a recognised gap in need. Outcome measures in future studies of interventions for children and adolescents living with serious parental mental illness are more likely to capture change in individual risk factors for reduced quality of life by considering their unmet need, rather than on an aggregate construct of health-related quality of life overall, which may not reflect these young people's needs.
FUTURE WORK


A public health approach to intervention might be best. Most children and adolescents living with serious parental mental illness remain well most of the time, so, although their absolute risks are low across outcomes (and most will remain resilient most of the time), consistent population estimates find their relative risk to be high compared with unexposed children. A public health approach to intervention needs to be both tailored to the particular needs of children and adolescents living with serious parental mental illness and agile to these needs so that it can respond to fluctuations over time.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN36865046.
FUNDING


This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 59. See the NIHR Journals Library website for further project information.",2020,"Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents.","['Children and adolescents living with their parents, who had serious mental illness', 'six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years', 'children and adolescents living with their parents, who had serious mental illness, and their parents', 'children and adolescents living with serious parental mental illness', 'children of parents with serious mental illness', 'A total of 35 families were recruited: 20', 'I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors', '40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators', 'Semistructured interviews with parents ( n \u2009=\u200914) and children ( n \u2009=\u200917) who participated']",['child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES'],"['quality of life', 'Quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557133', 'cui_str': 'Lives with parents'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",35.0,0.0615208,"Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents.","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Abel', 'Affiliation': ""Centre for Women's Mental Health, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Bee', 'Affiliation': 'Division of Nursing, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Gega', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gellatly', 'Affiliation': ""Centre for Women's Mental Health, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Adekeye', 'Initials': 'A', 'LastName': 'Kolade', 'Affiliation': ""Centre for Women's Mental Health, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'National Society for the Prevention of Cruelty to Children, London, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Callender', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lesley-Anne', 'Initials': 'LA', 'LastName': 'Carter', 'Affiliation': 'Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Meacock', 'Affiliation': 'Manchester Centre for Health Economics, University of Manchester, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'National Primary Care Research and Development Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Stanley', 'Affiliation': 'School of Social Work, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Calam', 'Affiliation': 'Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Wolpert', 'Affiliation': 'Evidence Based Practice Unit, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stewart', 'Affiliation': 'National Society for the Prevention of Cruelty to Children, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department for Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Linklater', 'Affiliation': 'Department of Education and Inclusive Pedagogy, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Douglas', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Stokes-Crossley', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24590']
2050,33198867,[Study on the effect of sedation strategy guided by driving pressure on prognosis of patients with mechanical ventilation].,"OBJECTIVE


To evaluate the effect of airway driving pressure (ΔP) guided sedation strategy on the prognosis of patients with mechanical ventilation.
METHODS


Patients who needed invasive mechanical ventilation and admitted to the department of intensive care unit (ICU) of Jiangxi Provincial People's Hospital from January 2017 to December 2018 were enrolled. The patients were divided into study group and control group according to the random number table. After informed consent of patients or their families, both groups received routine treatment in ICU. The control group was treated with light sedation strategy, the Richmond agitation sedation score (RASS) was performed every 4 hours, and the target was RASS > -3. ΔP in the study group was measured once a day, and the sedative target of patients with low driving pressure (ΔP ≤ 14 cmH 2 O, 1 cmH 2 O = 0.098 kPa) was RASS > -3, while the patients with high driving pressure (ΔP > 14 cmH 2 O) was RASS ≤ -3. The evaluation was conducted at 28 days after admission to ICU, and the patients were followed up to 60 days. The main outcome was days without mechanical ventilation in 28 days. The secondary outcomes were the rate of extubation, discharge outcome, incidence of ventilator associated pneumonia (VAP) and delirium, and 60-day survival rate.
RESULTS


A total of 60 patients with respiratory failure due to various reasons were recruited, 30 in each group. There was no significant difference in gender, age, primary disease, severity of disease or ΔP between the two groups. The days without mechanical ventilation within 28 days in the study group were significantly more than that in the control group [days: 20 (0, 23) vs. 12 (0, 16), P = 0.018], and the incidences of VAP (3.3% vs. 16.7%, P = 0.045) and delirium (0% vs. 10.0%, P = 0.038) were significantly lower than that in the control group. There were no significant differences in the rate of extubation (73.3% vs. 66.7%, P = 0.273), discharge outcome [improvement (cases): 24 vs. 21, unhealed (cases): 2 vs. 5, deaths (cases): 4 vs. 4, P = 0.506] and 60-day survival rate (83.3% vs. 76.7%, P = 0.519) between the study group and control group.
CONCLUSIONS


Compared with light sedation strategy, ΔP directed sedation strategy can effectively shorten the duration of mechanical ventilation and reduce the incidence of VAP and delirium in the ICU patients.",2020,"There was no significant difference in gender, age, primary disease, severity of disease or ΔP between the two groups.","['60 patients with respiratory failure due to various reasons were recruited, 30 in each group', 'patients with mechanical ventilation', ""Patients who needed invasive mechanical ventilation and admitted to the department of intensive care unit (ICU) of Jiangxi Provincial People's Hospital from January 2017 to December 2018 were enrolled""]","['sedation strategy guided by driving pressure', 'airway driving pressure (ΔP) guided sedation strategy']","['rate of extubation, discharge outcome, incidence of ventilator associated pneumonia (VAP) and delirium, and 60-day survival rate', 'delirium', 'rate of extubation', 'duration of mechanical ventilation', 'incidence of VAP and delirium', 'discharge outcome', 'incidences of VAP', '60-day survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}]",60.0,0.0597014,"There was no significant difference in gender, age, primary disease, severity of disease or ΔP between the two groups.","[{'ForeName': 'Huiwei', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Department of Critical Care Medicine, Jiangxi Provincial People's Hospital, Nanchang 330006, Jiangxi, China. Corresponding author: Yang Chunli, Email: ycl121@163.com.""}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Liqion', 'Initials': 'L', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Wenhan', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200514-00385']
2051,33199051,Effect of mindfulness intervention versus health education program on salivary Aβ-42 levels in community-dwelling older adults with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Few randomized controlled trials have investigated the effects of mindfulness intervention on older adults diagnosed with mild cognitive impairment (MCI). Specifically, scarce literature exists on the potential benefits of mindfulness intervention on biomarkers representing AD hallmarks. Our previous studies showed the potential of Mindful Awareness Practice (MAP) in improving multiple biomarkers of gut microbiota, systemic inflammation, and synaptic functions. Extending these findings, in this study, we conducted analysis on bio-banked saliva samples, examining whether MAP improved salivary amyloid beta-42 (Aβ-42) levels in community-dwelling older adults diagnosed with MCI. We also explored the moderating role of education level, an indicator of cognitive reserve, on intervention effect.
METHODS


A total of 55 community-dwelling older adults diagnosed with MCI were randomized into either the treatment arm, MAP, or the active control arm, the health education program (HEP). Interventions were performed for a total of nine months. Field and laboratory investigators who were blinded to the treatment allocations collected saliva samples at baseline, 3-month, and 9-month follow-ups. Salivary Aβ-42 levels were quantified using a commercial assay. Linear-mixed models were used to examine the effect of MAP on salivary Aβ-42 levels.
RESULTS


Compared to the HEP arm, MAP participants had no significantly modified Aβ-42 levels throughout the 9-month intervention period, regardless of subgroup analyses stratified by either sex or MCI-subtypes (amnestic and non-amnestic). Exploring the moderating effect of education, participants in the HEP arm with higher education levels had significantly lower salivary Aβ-42 at 3-month time-point.
DISCUSSION


Taken together with our previous findings and other mindfulness interventional studies failing to find a significant effect on peripheral Aβ-42, we conclude the non-significant effects of mindfulness intervention on ameliorating peripheral Aβ-42 levels. Conversely, participants in the HEP arm with higher cognitive reserve had significantly improved salivary Aβ-42, highlighting the role of cognitive reserve in moderating treatment response in MCI.",2020,"Compared to the HEP arm, MAP participants had no significantly modified Aβ-42 levels throughout the 9-month intervention period, regardless of subgroup analyses stratified by either sex or MCI-subtypes (amnestic and non-amnestic).","['older adults diagnosed with mild cognitive impairment (MCI', 'community-dwelling older adults diagnosed with MCI', 'community-dwelling older adults with mild cognitive impairment', '55 community-dwelling older adults diagnosed with MCI']","['mindfulness intervention', 'mindfulness intervention versus health education program', 'MAP, or the active control arm, the health education program (HEP']","['ameliorating peripheral Aβ-42 levels', 'salivary amyloid beta-42 (Aβ-42) levels', 'salivary Aβ-42 levels', 'salivary Aβ-42', 'modified Aβ-42 levels', 'Salivary Aβ-42 levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",55.0,0.033167,"Compared to the HEP arm, MAP participants had no significantly modified Aβ-42 levels throughout the 9-month intervention period, regardless of subgroup analyses stratified by either sex or MCI-subtypes (amnestic and non-amnestic).","[{'ForeName': 'Ted Kheng Siang', 'Initials': 'TKS', 'LastName': 'Ng', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore. Electronic address: a0047115@u.nus.edu.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Slowey', 'Affiliation': 'Oasis Diagnostics® Corporation, Vancouver, WA, USA; Central South University, Changsha, China.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beltran', 'Affiliation': 'Oasis Diagnostics® Corporation, Vancouver, WA, USA.'}, {'ForeName': 'Roger C M', 'Initials': 'RCM', 'LastName': 'Ho', 'Affiliation': 'Department of Psychological Medicine, National University Hospital, Singapore; Biomedical Global Institute of Healthcare Research & Technology (BIGHEART), National University of Singapore, Singapore; Center of Excellence in Behavioral Medicine, Nguyen Tat Thanh University, Faculty of Education, Huaibei Normal University, Vietnam, China.'}, {'ForeName': 'Ee Heok', 'Initials': 'EH', 'LastName': 'Kua', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore; Department of Psychological Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Rathi', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Psychological Medicine, National University of Singapore, Singapore; Department of Psychological Medicine, National University Hospital, Singapore; Academic Development Department, Duke-NUS Medical School, 8 College Road, Singapore.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.10.038']
2052,33199052,Effects of mindfulness-based stress reduction on psychological distress in health workers: A three-arm parallel randomized controlled trial.,"Mindfulness-based Stress Reduction (MBSR) has shown good efficacy for improving wellbeing in employees experiencing occupational stress. However, comparisons with other interventions, longer-term follow-up, and data from varying sociocultural contexts are lacking. This three-arm, parallel randomised controlled trial (RCT) examined the effects of MBSR on psychological distress in non-physician health workers in direct contact with patients. 105 participants were randomly allocated to either: (1) MBSR (N = 35), (2) Stress Management Course (SMC; N = 34) or (3) wait-list (N = 36). Participants and those assessing outcomes were blinded to group assignment. Participants completed questionnaires pre- and post-intervention and four months after the intervention. Psychological distress was measured using the General Health Questionnaire (GHQ-12) and Outcome Questionnaire (OQ-45). Secondary outcomes included perceived stress, job satisfaction, mindfulness skills and changes in salivary cortisol. 77 participants completed measures post-intervention and 52 at 4-month follow-up. MBSR showed a post-intervention effect in reducing GHQ-12 (ß = -0.80 [SE = 1.58] p < 0.01) and OQ-45 (ß = -0.72, [SE = 5.87] p < 0.05) psychological distress, compared to SMC and in reducing GHQ-12 (ß = -1.30 [SE = 1.38] p < 0.001) and OQ-45 (ß = -0.71, [SE = 5.58] p < 0.01) psychological distress compared to wait-list condition. In our secondary outcome, only MBSR was associated with a decrease in the cortisol awaking response by 23% (p < 0.05). At follow-up, only effects of MBSR on the psychological distress 'social role' subscale (ß = -0.76 [SE = 1.31] p < 0.05) remained significant, compared to SMC. In conclusion, MBSR appears useful in reducing short-term psychological distress in healthcare workers, but these effects were not maintained at follow-up. Trial registration: ISRCTN12039804.",2020,MBSR showed a post-intervention effect in reducing GHQ-12,"['employees experiencing occupational stress', 'healthcare workers', 'health workers', 'non-physician health workers in direct contact with patients', '77 participants completed measures post-intervention and 52\xa0at 4-month follow-up', '105 participants']","['mindfulness-based stress reduction', 'MBSR', 'Mindfulness-based Stress Reduction (MBSR', 'GHQ-12', 'MBSR (N\xa0=\xa035), (2) Stress Management Course (SMC; N\xa0=\xa034) or (3) wait-list']","['psychological distress', 'MBSR', 'Psychological distress', 'GHQ-12', 'short-term psychological distress', 'General Health Questionnaire (GHQ-12) and Outcome Questionnaire (OQ-45', 'OQ-45', 'cortisol awaking response', 'perceived stress, job satisfaction, mindfulness skills and changes in salivary cortisol', ""psychological distress 'social role' subscale""]","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",105.0,0.0532204,MBSR showed a post-intervention effect in reducing GHQ-12,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Errazuriz', 'Affiliation': 'Department of Psychiatry, School of Medicine, Pontificia Universidad Catolica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile; Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP, Vicuña Mackenna 4860, Santiago, 7820436, Chile. Electronic address: anerrazuriz@uc.cl.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychiatry, School of Medicine, Pontificia Universidad Catolica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile. Electronic address: kristin.schmidt.01@gmail.com.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Undurraga', 'Affiliation': 'School of Government, Pontificia Universidad Catolica de Chile, Vicuña Mackenna 4860, Santiago, 7820436, Chile; Millennium Nucleus for the Study of the Life Course and Vulnerability, Vicuña Mackenna 4860, Santiago, 7820436, Chile; Millennium Initiative for Collaborative Research in Bacterial Resistance (MICROB-R), Avenida Las Condes 12.461, Torre 3, oficina 205, Las Condes, Santiago, 7820436, Chile. Electronic address: eundurra@uc.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Medeiros', 'Affiliation': 'Department of Psychiatry, School of Medicine, Pontificia Universidad Catolica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile; Millennium Science Initiative /Millennium Institute for Research on Depression and Personality-MIDAP, Vicuña Mackenna 4860, Santiago, 7820436, Chile. Electronic address: smedeiro@uc.cl.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Baudrand', 'Affiliation': 'Endocrinology Department, School of Medicine, Pontificia Universidad Catolica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile; Program for Adrenal Disorders, CETREN UC, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile. Electronic address: rbaudran@uc.cl.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Cussen', 'Affiliation': 'Institute of Economics, Pontificia Universidad Catolica de Chile, Vicuña Mackenna 4860, Santiago, 7820436, Chile. Electronic address: dcussen1@uc.cl.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Henriquez', 'Affiliation': 'Department of Clinical Laboratory Medicine, Pontificia Universidad Catolica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile. Electronic address: mphenriq@uc.cl.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Celhay', 'Affiliation': 'School of Government, Pontificia Universidad Catolica de Chile, Vicuña Mackenna 4860, Santiago, 7820436, Chile; Millennium Nucleus for the Study of the Life Course and Vulnerability, Vicuña Mackenna 4860, Santiago, 7820436, Chile. Electronic address: pacelhay@uc.cl.'}, {'ForeName': 'Rodrigo A', 'Initials': 'RA', 'LastName': 'Figueroa', 'Affiliation': 'Department of Psychiatry, School of Medicine, Pontificia Universidad Catolica de Chile, Diagonal Paraguay 362, Santiago, 8330077, Chile. Electronic address: rfiguerc@uc.cl.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.11.011']
2053,30414228,Development of sleep patterns in children with obese and normal-weight parents.,"AIM


To study the sleep development and sleep characteristics in children at different obesity risks, based on parental weight, and also to explore their weekday-weekend sleep variations and associated family factors.
METHODS


A total of 145 children participating in a longitudinal obesity prevention project were included, of which 37 had normal-weight parents (low obesity risk), and 108 had overweight/obese parents (high obesity risk). Sleep diaries at ages 1 and 2 years were used to study sleep development in children at different obesity risks. Objectively assessed sleep using an accelerometer at 2 years of age was used to analyse weekday-weekend sleep variations.
RESULTS


There was no difference in sleep development from age 1 to age 2 among children at different obesity risks, but more children in the high-risk group had prolonged sleep onset latency and low sleep efficiency. At 2 years of age, children in the high-risk group had more weekday-weekend variation in sleep offset (mean difference 18 min, 95% confidence interval (CI) 4-33 min), midpoint of sleep (mean difference 14 min, 95% CI 3-25 min) and nap onset (mean difference 42 min, 95% CI 10-74 min) than children in the low-risk group, after adjusting for other family factors. However, no difference could be detected between groups in weekday-weekend variation in sleep duration.
CONCLUSIONS


Unfavourable sleep characteristics, as well as more variation in sleep schedules, have been observed in children at high obesity risk. While the differences were relatively small, they may reflect the unfavourable sleep hygiene in families at high obesity risk.",2019,"There was no difference in sleep development from age 1 to age 2 among children at different obesity risks, but more children in the high-risk group had prolonged sleep onset latency and low sleep efficiency.","['children with obese and normal-weight parents', '145 children participating in a longitudinal obesity prevention project were included, of which 37 had normal-weight parents (low obesity risk), and 108 had overweight/obese parents (high obesity risk', 'children at different obesity risks', 'children at high obesity risk']",[],"['Sleep diaries', 'weekday-weekend variation in sleep offset', 'midpoint of sleep', 'prolonged sleep onset latency and low sleep efficiency', 'sleep development']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0234452', 'cui_str': 'Prolonged sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",145.0,0.0803222,"There was no difference in sleep development from age 1 to age 2 among children at different obesity risks, but more children in the high-risk group had prolonged sleep onset latency and low sleep efficiency.","[{'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Xiu', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hagströmer', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Bergqvist-Norén', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Johansson', 'Affiliation': 'Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ekbom', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Svensson', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Marcus', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Ekstedt', 'Affiliation': 'Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institutet, Stockholm, Sweden.'}]",Journal of paediatrics and child health,['10.1111/jpc.14294']
2054,30785358,"Immune thrombocytopenia in alemtuzumab-treated MS patients: Incidence, detection, and management.","BACKGROUND


Alemtuzumab is a highly effective therapy for relapsing-remitting multiple sclerosis (RRMS), and immune thrombocytopenia (ITP) has been identified as a risk.
OBJECTIVE


To examine ITP incidence, treatment, and outcomes during the clinical development of alemtuzumab for RRMS and discuss postmarketing experience outside clinical trials.
METHODS


CAMMS223 and Comparison of Alemtuzumab and Rebif ®  Efficacy in Multiple Sclerosis (CARE-MS) I and II investigated two annual courses of alemtuzumab 12 mg (or 24 mg in CAMMS223/CARE-MS II) versus subcutaneous interferon beta-1a three times per week. Patients completing core studies could enroll in an extension. Monthly monitoring for ITP continued until 48 months after the last alemtuzumab infusion.
RESULTS


Of 1485 alemtuzumab-treated MS patients in the clinical development program, 33 (2.2%) developed ITP (alemtuzumab 12 mg, 24 [2.0%]; alemtuzumab 24 mg, 9 [3.3%]) over median 6.1 years of follow-up after the first infusion; most had a sustained response to first-line ITP therapy with corticosteroids, platelets, and/or intravenous immunoglobulin. All cases occurred within 48 months of the last alemtuzumab infusion. Postmarketing surveillance data suggest that the ITP incidence is not higher in clinical practice than in clinical trials.
CONCLUSION


Alemtuzumab-associated ITP occurs in approximately 2% of patients and is responsive to therapy. Careful monitoring is key for detection and favorable outcomes.",2020,"RESULTS


Of 1485 alemtuzumab-treated MS patients in the clinical development program, 33 (2.2%) developed ITP (alemtuzumab 12 mg, 24 [2.0%];",['Multiple Sclerosis (CARE-MS'],"['alemtuzumab 12\u2009mg (or 24\u2009mg in CAMMS223/CARE-MS II) versus subcutaneous interferon', 'Alemtuzumab and Rebif ®', 'alemtuzumab', 'Alemtuzumab']","['ITP', 'Immune thrombocytopenia']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0752980', 'cui_str': 'Rebif'}]","[{'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}]",,0.0272215,"RESULTS


Of 1485 alemtuzumab-treated MS patients in the clinical development program, 33 (2.2%) developed ITP (alemtuzumab 12 mg, 24 [2.0%];","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cuker', 'Affiliation': 'Departments of Medicine and Pathology & Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Bass', 'Affiliation': 'Neurology Center of San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Congor', 'Initials': 'C', 'LastName': 'Nadj', 'Affiliation': 'Institute of Neurology, Novi Sad, Serbia.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Agius', 'Affiliation': 'Woodland Clinic, Dignity Health, Woodland, CA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Steingo', 'Affiliation': 'Fort Lauderdale MS Center, Pompano Beach, FL, USA.'}, {'ForeName': 'Krzysztof W', 'Initials': 'KW', 'LastName': 'Selmaj', 'Affiliation': 'University of Warmia and Mazury in Olsztyn, Olsztyn, Poland.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Thoits', 'Affiliation': 'College of Human Medicine, MSU Spectrum Health, Grand Rapids, MI, USA.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Guerreiro', 'Affiliation': 'Instituto de Doenças Neurológicas do Hospital Mãe de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Van Wijmeersch', 'Affiliation': 'Rehabilitation and MS Centre Overpelt, BIOMED, University of Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Tjalf', 'Initials': 'T', 'LastName': 'Ziemssen', 'Affiliation': 'Center of Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Sven G', 'Initials': 'SG', 'LastName': 'Meuth', 'Affiliation': 'Department of Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'LaGanke', 'Affiliation': 'North Central Neurology Associates, Cullman, AL, USA.'}, {'ForeName': 'Karthinathan', 'Initials': 'K', 'LastName': 'Thangavelu', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Rodriguez', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Baker', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Margolin', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Jannsens', 'Affiliation': 'Department of Haematology, University Hospitals Leuven, Leuven, Belgium.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518816612']
2055,33196565,A Phase IV clinical study to evaluate the effects of an intracameral combined mydriatic and anesthetic agent and standard topical mydriatics and anesthetics on the ocular surface after cataract surgery.,"PURPOSE


To compare intracameral and topical mydriatics and anesthetics in cataract surgery. The primary endpoint was the change from baseline in corneal/conjunctival surface staining. Secondary endpoints included assessments of epithelial alterations, point spread function, ocular surface disease index, conjunctival hyperemia, vision break-up time, ocular symptoms/signs, adverse events, best-corrected visual acuity, intraocular pressure, patient/investigator satisfaction, and procedure time.
SETTING


Ocular microsurgery institute.
DESIGN


Phase IV, open-label, randomized, single-center study in 50 patients undergoing sequential cataract surgery in both eyes.
METHODS


Patients were randomized in a 1:1 ratio to receive intracameral mydriatic-anesthetic (Mydrane/Fydrane, Laboratoires Théa) and anesthetic eye drops or control (topical eye drops only). The other treatment was administered for the second cataract surgery. Assessments were pre- and post-surgery, 12-36 hours (Day 1) and 7 days post-surgery.
RESULTS


Baseline assessments were similar in each group. The difference between Fydrane and control for the change from baseline at Day 1 in corneal and conjunctival surface staining was not statistically significant. For Fydrane, post-operative epithelial alterations were fewer at Day 1 (p<0.005), folliculo-papillary reaction was less frequent (p<0.05), some ocular symptoms were less frequent and milder (p<0.05), length of procedure was shorter (p<0.001), and patient and investigator satisfaction were better (p<0.05). There were few adverse events in both groups.
CONCLUSIONS


Fydrane reduced ocular surface damage by decreasing corneal epithelial and conjunctival toxicity with faster recovery of surface integrity compared to topical eye drops, improved patient and investigator satisfaction, and procedure time.",2020,"For Fydrane, post-operative epithelial alterations were fewer at Day 1 (p<0.005), folliculo-papillary reaction was less frequent (p<0.05), some ocular symptoms were less frequent and milder (p<0.05), length of procedure was shorter (p<0.001), and patient and investigator satisfaction were better (p<0.05).","['Patients', 'Ocular microsurgery institute', 'after cataract surgery', '50 patients undergoing sequential cataract surgery in both eyes', 'cataract surgery']","['intracameral and topical mydriatics and anesthetics', 'intracameral mydriatic-anesthetic (Mydrane/Fydrane, Laboratoires Théa) and anesthetic eye drops or control (topical eye drops only', 'intracameral combined mydriatic and anesthetic agent and standard topical mydriatics and anesthetics']","['length of procedure was shorter (p<0.001), and patient and investigator satisfaction', 'epithelial alterations, point spread function, ocular surface disease index, conjunctival hyperemia, vision break-up time, ocular symptoms/signs, adverse events, best-corrected visual acuity, intraocular pressure, patient/investigator satisfaction, and procedure time', 'corneal and conjunctival surface staining', 'change from baseline in corneal/conjunctival surface staining', 'patient and investigator satisfaction, and procedure time', 'ocular surface', 'corneal epithelial and conjunctival toxicity', 'folliculo-papillary reaction', 'ocular symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1299418', 'cui_str': 'Length of procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",50.0,0.080998,"For Fydrane, post-operative epithelial alterations were fewer at Day 1 (p<0.005), folliculo-papillary reaction was less frequent (p<0.05), some ocular symptoms were less frequent and milder (p<0.05), length of procedure was shorter (p<0.001), and patient and investigator satisfaction were better (p<0.05).","[{'ForeName': 'Spyridoula', 'Initials': 'S', 'LastName': 'Souki', 'Affiliation': 'Institute of Ocular Microsurgery, Barcelona, Spain.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Cochener', 'Affiliation': 'CHU Morvan, Brest, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Labetoulle', 'Affiliation': 'Hôpital Bicêtre, Université Paris Sud, Paris, France.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Güell', 'Affiliation': 'Institute of Ocular Microsurgery, Barcelona, Spain.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000491']
2056,33196566,Prospective comparison of apex-centered versus standard pupil- centered femtosecond-laser assisted capsulotomy in cataract surgery.,"PURPOSE


Since recently the Victus femtosecond-laser platform is able to center the capsulotomy on the lens apex in femtosecond-laser assisted cataract surgery (FLACS). Aim of the study was to compare the lens tilt after apex-centered capsulotomy with standard pupil-centered capsulotomy.
SETTING


Clinical practice.
DESIGN


Prospective, randomized, investigator-masked trial.
METHODS


This prospective, randomized, investigator masked study included 40 patients with age-related cataract scheduled for FLACS in both eyes. The main outcome was the tilt of the intraocular lens, measured with the IOL Master 700 (Zeiss).
RESULTS


The study enrolled 80 eyes of 40 patients. Mean distance from the center of the apex-centered capsulotomy to the pupil-centered capsulotomy was 175.8 ± 97.2 µm. The amount of IOL tilt was not significantly reduced with the novel technique (p>0.05). Tilt orientation was more stable in eyes treated with apex-centered capsulotomy.
CONCLUSION


Centration of the capsulotomy on the lens apex in FLACS does not influence the amount of IOL tilt but the orientation stability. The clinical importance of this finding has to be further elucidated.",2020,The amount of IOL tilt was not significantly reduced with the novel technique (p>0.05).,"['cataract surgery', '40 patients with age-related cataract scheduled for FLACS in both eyes', 'study enrolled 80 eyes of 40 patients']","['lens tilt after apex-centered capsulotomy with standard pupil-centered capsulotomy', 'apex-centered versus standard pupil- centered femtosecond-laser assisted capsulotomy', 'femtosecond-laser assisted cataract surgery (FLACS']","['Tilt orientation', 'tilt of the intraocular lens, measured with the IOL Master 700 (Zeiss', 'Mean distance', 'amount of IOL tilt']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1689968', 'cui_str': 'Tilted intraocular lens'}]",40.0,0.0285822,The amount of IOL tilt was not significantly reduced with the novel technique (p>0.05).,"[{'ForeName': 'Anna Sophie', 'Initials': 'AS', 'LastName': 'Mursch-Edlmayr', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'Leon Julian', 'Initials': 'LJ', 'LastName': 'Pomberger', 'Affiliation': 'Medical University Vienna, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hermann', 'Affiliation': 'Johannes Kepler University, Center for Clinical Studies (CCS Linz), Linz, Austria.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Johannes Kepler University, Center for Clinical Studies (CCS Linz), Linz, Austria.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Beka', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Waser', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'Jascha', 'Initials': 'J', 'LastName': 'Wendelstein', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Podkowinski', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Laubichler', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Siska', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bolz', 'Affiliation': 'Johannes Kepler University Linz, Kepler University Hospital GmbH, Department for Ophthalmology, Linz, Austria.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000496']
2057,33196567,Descemet Stripping Automated Endothelial Keratoplasty with Intrascleral Haptic Fixated Intraocular Lens in a Sequential versus Simultaneous approach.,"PURPOSE


To compare the outcomes of Descemet stripping automated endothelial keratoplasty (DSAEK) with intrascleral haptic fixated IOL in a sequential and simultaneous approach.
SETTING


Tertiary Eye Care Centre DESIGN:: Prospective Randomized Comparative Study METHOD:: Patients with aphakic or complicated pseudophakic bullous keratopathy visiting a tertiary eye care Centre were included in the study. A total of 40 patients were randomized into two groups of 20 each. Group-1 had subjects who underwent scleral fixated intraocular lens implantation (SFIOL) by intrascleral haptic fixation technique followed by DSAEK (sequential procedure) with an interval of at least 3 months. Group-2 (simultaneous) had subjects who underwent DSAEK with SFIOL as combined procedure. Graft survival, endothelial cell loss (ECL), corrected distance visual acuity (CDVA) and need for any intervention like rebubbling were evaluated for both the groups at the end of 6 months.
RESULTS


At 6 months the sequential group had significantly better CDVA of 0.62±0.17 logarithm of the minimum angle of resolution (logMAR) compared with 0.87±0.19 logMAR in simultaneous group (P=0.002). Group-1 had significantly better overall cumulative graft survival (100% versus 60%, P = 0.002), significantly lower ECL (P=0.006), lesser mean central corneal thickness (P=0.03), and significantly thinner donor lenticule (P=0.009). Rebubbling rate was significantly higher in Group-2 (P=0.025). The mean hyperopic shift was significantly more in Group-2 (P=0.02).
CONCLUSION


The sequential procedure of SFIOL followed by DSAEK has better visual outcomes and graft survival as compared to simultaneous procedure in cases of aphakic or complicated pseudophakic bullous keratopathy.",2020,"Group-1 had significantly better overall cumulative graft survival (100% versus 60%, P = 0.002), significantly lower ECL (P=0.006), lesser mean central corneal thickness (P=0.03), and significantly thinner donor lenticule (P=0.009).","[' Patients with aphakic or complicated pseudophakic bullous keratopathy visiting a tertiary eye care Centre were included in the study', 'Tertiary Eye Care Centre DESIGN', '40 patients']","['Descemet stripping automated endothelial keratoplasty (DSAEK) with intrascleral haptic fixated IOL', 'Descemet Stripping Automated Endothelial Keratoplasty with Intrascleral Haptic Fixated Intraocular Lens', 'scleral fixated intraocular lens implantation (SFIOL) by intrascleral haptic fixation technique followed by DSAEK (sequential procedure']","['Rebubbling rate', 'minimum angle of resolution (logMAR', 'mean hyperopic shift', 'visual outcomes and graft survival', 'overall cumulative graft survival', 'Graft survival, endothelial cell loss (ECL), corrected distance visual acuity (CDVA) and need for any intervention like rebubbling', 'mean central corneal thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0339263', 'cui_str': 'Pseudophakic corneal edema'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}]",40.0,0.0306174,"Group-1 had significantly better overall cumulative graft survival (100% versus 60%, P = 0.002), significantly lower ECL (P=0.006), lesser mean central corneal thickness (P=0.03), and significantly thinner donor lenticule (P=0.009).","[{'ForeName': 'Dr Rajesh', 'Initials': 'DR', 'LastName': 'Sinha', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Dr Hannah', 'Initials': 'DH', 'LastName': 'Shiny', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Dr Sridevi', 'Initials': 'DS', 'LastName': 'Nair', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Dr Namrata', 'Initials': 'DN', 'LastName': 'Sharma', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Dr Tushar', 'Initials': 'DT', 'LastName': 'Agarwal', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}, {'ForeName': 'Dr Jeewan', 'Initials': 'DJ', 'LastName': 'Singh Titiyal', 'Affiliation': 'Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, 110029, India.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000503']
2058,33196570,Choroidal thickness after phacoemulsification; a non-randomized comparison of postoperative topical ketorolac versus dexamethasone versus a combination of ketorolac-dexamethasone eye drops.,"PURPOSE


To compare the effect of topical dexamethasone versus ketorolac versus combined dexamethasone-ketorolac after phacoemulsification on choroidal thickness (CT).
SETTING


A tertiary university-based hospital Design: Prospective non-randomized comparative case series METHODS:: Ninety-two eyes of 92 patients were assigned to the three groups after uneventful phacoemulsification. Group 1, dexamethasone; group 2, ketorolac; group 3, combined dexamethasone-ketorolac that applied topically. Choroidal thickness (CT) at subfoveal (SFCT), nasal and temporal as primary and central retinal thickness (CRT) as secondary outcomes were measured preoperatively, and 1, 3, and 6 months postoperatively using enhanced depth imaging optical coherence tomography.
RESULTS


Preoperative CT were similar between the groups (all P>0.05). The groups differed in pattern of changes in nasal and temporal CT (both P<0.001) although their changes of CRT (P=0.13) and SFCT (P=0.55) over time were similar. The mean of SFCT at months 1, 3 and 6 was significantly higher than baseline in dexamethasone (P<0.001 for all follow-ups) and combined (P<0.001 for both month 1 and 3 and P=0.03 for month 6) groups while it was not significant in the ketorolac group (P=0.07). There was an increase in the nasal and temporal CT in three groups, persisted at month 6 in dexamethasone (both P<0.001) and ketorolac (both P<0.001) groups while the change was not statistically significant at month 6 in combined group.
CONCLUSION


Dexamethasone and combined groups had statistically significant changes of SFCT after phacoemulsification however, the ketorolac group did not. The pattern of SFCT changes was similar between three groups.",2020,"There was an increase in the nasal and temporal CT in three groups, persisted at month 6 in dexamethasone (both P<0.001) and ketorolac (both P<0.001) groups while the change was not statistically significant at month 6 in combined group.
","[' Ninety-two eyes of 92 patients', 'A tertiary university-based hospital Design']","['ketorolac', 'topical dexamethasone', 'dexamethasone-ketorolac', 'dexamethasone', 'Dexamethasone', 'postoperative topical ketorolac', 'ketorolac-dexamethasone']","['changes in nasal and temporal CT', 'SFCT', 'Choroidal thickness (CT) at subfoveal (SFCT), nasal and temporal as primary and central retinal thickness (CRT', 'nasal and temporal CT', 'Choroidal thickness', 'mean of SFCT', 'choroidal thickness (CT', 'SFCT changes']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019962', 'cui_str': 'Hospital Design'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",92.0,0.0257525,"There was an increase in the nasal and temporal CT in three groups, persisted at month 6 in dexamethasone (both P<0.001) and ketorolac (both P<0.001) groups while the change was not statistically significant at month 6 in combined group.
","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghiasian', 'Affiliation': 'Eye Research Center, The Five Senses Institute, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kaveh Abri', 'Initials': 'KA', 'LastName': 'Aghdam', 'Affiliation': 'Eye Research Center, The Five Senses Institute, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Azizi', 'Affiliation': 'Eye Research Center, The Five Senses Institute, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Abdolalizadeh', 'Affiliation': 'Eye Research Center, The Five Senses Institute, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Grzybowski', 'Affiliation': 'Department of Ophthalmology, University of Warmia and Mazury, Olsztyn, Poland. 4- Institute for Research in Ophthalmology, Poznan, Poland.'}, {'ForeName': 'Khalil Ghasemi', 'Initials': 'KG', 'LastName': 'Falavarjani', 'Affiliation': 'Eye Research Center, The Five Senses Institute, Rassoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000477']
2059,33196574,Preoperative and perioperative music to reduce anxiety during first-time phacoemulsification cataract surgery in the high-volume setting: randomized controlled trial.,"PURPOSE


To determine if preoperative and perioperative music exposure reduced patient self-rated anxiety and physiologic indicators of stress during first-time phacoemulsification cataract surgery in the high-volume setting.
SETTING


Aravind Eye Care System, Pondicherry, India.
DESIGN


Prospective single-masked randomized controlled trial.
METHODS


Patients were provided music before and during first-time phacoemulsification in one group and patients underwent surgery without music in another group. Measurements of blood pressure, heart rate, respiration rate, and a Likert-scale anxiety rating were collected at preoperative, perioperative, and postoperative time points.
RESULTS


165 patients (aged 53-65) were provided music via a portable MP3 player before and during first-time phacoemulsification, and 165 patients underwent surgery without music. Systolic and diastolic blood pressures were significantly lower in the music intervention group at the postoperative time point, with similar physiologic measures between groups during the perioperative time points. In the preoperative period before music exposure, 62 patients (38%) in the music group reported being very or extremely anxious. After 10 minutes of music exposure, only 7 patients (4%) reported this anxiety level. In the perioperative period, 80 patients (48%) in the intervention group reported feeling not at all or a little anxious, compared to 50 patients (30%) of the control group. In the postoperative period, 139 (84%) music group patients felt not at all or a little anxious after surgery compared with 92 patients (56%) in the control group.
CONCLUSION


Marked reductions in self-reported anxiety before, during, and after surgery when exposed to music and a significant decrease in postoperative blood pressure showed music can be an inexpensive and effective solution to improve the patient experience of cataract surgery in the high-volume setting.",2020,"Systolic and diastolic blood pressures were significantly lower in the music intervention group at the postoperative time point, with similar physiologic measures between groups during the perioperative time points.",['165 patients (aged 53-65'],"['surgery without music in another group', 'surgery without music', 'Preoperative and perioperative music to reduce anxiety during first-time phacoemulsification cataract surgery']","['postoperative blood pressure', 'anxiety level', 'blood pressure, heart rate, respiration rate, and a Likert-scale anxiety rating', 'Systolic and diastolic blood pressures']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",165.0,0.0927149,"Systolic and diastolic blood pressures were significantly lower in the music intervention group at the postoperative time point, with similar physiologic measures between groups during the perioperative time points.","[{'ForeName': 'Satish Kumar', 'Initials': 'SK', 'LastName': 'Muddana', 'Affiliation': 'From Aravind Eye Hospital, Pondicherry, India (Muddana, Venkatesh); Stanford University School of Medicine, Stanford, California, (Hess); Mahatma Gandhi Medical College and Research Institute, Pondicherry, India (Sundar).'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Hess', 'Affiliation': ''}, {'ForeName': 'Sumathy', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': ''}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000485']
2060,33196584,"Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study.","BACKGROUND


Forty percent of long bone fractures involve the tibia. These fractures are associated with prolonged recovery and may adversely affect patients' long-term physical functioning; however, there is limited evidence to inform what factors influence functional recovery in this patient population.
QUESTION/PURPOSE


In a secondary analysis of a previous randomized trial, we asked: What fracture-related, demographic, social, or rehabilitative factors were associated with physical function 1 year after reamed intramedullary nailing of open or closed tibial shaft fractures?
METHODS


This is a secondary (retrospective) analysis of a prior randomized trial (Trial to Re-evaluate Ultrasound in the Treatment of Tibial Fractures; TRUST trial). In the TRUST trial, 501 patients with unilateral open or closed tibial shaft fractures were randomized to self-administer daily low-intensity pulsed ultrasound or use a sham device, of which 15% (73 of 501) were not followed for 1 year due to early study termination as a result of futility (no difference between active and sham interventions). Of the remaining patients, 70% (299 of 428) provided full data. All fractures were fixed using reamed (298 of 299) or unreamed (1 of 299) intramedullary nailing. Thus, we excluded the sole fracture fixed using unreamed intramedullary nailing. The co-primary study outcomes of the TRUST trial were time to radiographic healing and SF-36 physical component summary (SF-36 PCS) scores at 1-year. SF-36 PCS scores range from 0 to 100, with higher scores being better, and the minimum clinically important difference (MCID) is 5 points. In this secondary analysis, based on clinical and biological rationale, we selected factors that may be associated with physical functioning as measured by SF-36 PCS scores. All selected factors were inserted simultaneously into a multivariate linear regression analysis.
RESULTS


After adjusting for potentially confounding factors, such as age, gender, and injury severity, we found that no factor showed an association that exceeded the MCID for physical functioning 1 year after intramedullary nailing for tibial shaft fractures. The independent variables associated with lower physical functioning were current smoking status (mean difference -3.0 [95% confidence interval -5 to -0.5]; p = 0.02), BMI > 30 kg/m (mean difference -3.0 [95% CI -5.0 to -0.3]; p = 0.03), and receipt of disability benefits or involvement in litigation, or plans to be (mean difference -3.0 [95% CI -5.0 to -1]; p = 0.007). Patients who were employed (mean difference 4.6 [95% CI 2.0 to 7]; p < 0.001) and those who were advised by their surgeon to partially or fully bear weight postoperatively (mean difference 2.0 [95% CI 0.1 to 4.0]; p = 0.04) were associated with higher physical functioning. Age, gender, fracture severity, and receipt of early physical therapy were not associated with physical functioning at 1-year following surgical fixation.
CONCLUSION


Among patients with tibial fractures, none of the factors we analyzed, including smoking status, receipt of disability benefits or involvement in litigation, or BMI, showed an association with physical functioning that exceeded the MCID.
LEVEL OF EVIDENCE


Level III, therapeutic study.",2020,"Age, gender, fracture severity, and receipt of early physical therapy were not associated with physical functioning at 1-year following surgical fixation.
","['501 patients with unilateral open or closed tibial shaft fractures', 'Tibial Shaft Fractures', 'patients with tibial fractures']","['reamed intramedullary nailing of open or closed tibial shaft fractures', 'unreamed intramedullary nailing', 'Intramedullary Nailing', 'unreamed (1 of 299) intramedullary nailing', 'self-administer daily low-intensity pulsed ultrasound or use a sham device']","['SF-36 PCS scores', 'smoking status, receipt of disability benefits or involvement in litigation, or BMI', 'time to radiographic healing and SF-36 physical component summary (SF-36 PCS) scores at 1-year. SF-36 PCS scores range', 'Smoking, Obesity, and Disability Benefits or Litigation', 'Physical Functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}]","[{'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588199', 'cui_str': 'Bone structure of shaft of tibia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4042796', 'cui_str': 'LIPUS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0079706', 'cui_str': 'Litigation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",501.0,0.0926991,"Age, gender, fracture severity, and receipt of early physical therapy were not associated with physical functioning at 1-year following surgical fixation.
","[{'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Findakli', 'Affiliation': 'F. Findakli, J. W. Busse, F. Farrokhyar, M. Bhandari, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada J. W. Busse, Department of Anesthesia, McMaster University, Hamilton, ON, Canada J. W. Busse, Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada J. W. Busse, The Canadian Veterans Chronic Pain Centre of Excellence, Hamilton, ON, Canada E. H. Schemitsch, Department of Surgery, University of Western Ontario, London, ON, Canada E. Lonn, Population Health Research Institute, McMaster University, Hamilton, ON, Canada M. Bhandari, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Busse', 'Affiliation': ''}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lonn', 'Affiliation': ''}, {'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Farrokhyar', 'Affiliation': ''}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001573']
2061,33196605,Exogenous Ketosis Impairs 30-min Time-Trial Performance Independent of Bicarbonate Supplementation.,"PURPOSE


We recently demonstrated that co-ingestion of NaHCO3 to counteract ketoacidosis resulting from oral ketone ester (KE) intake improves mean power output during a 15-min TT at the end of a 3h cycling race by ~5%. This ergogenic effect occurred at a time when blood ketone levels were low as ketosis was only induced during the initial ~2h of the race. Therefore, in the current study we investigated whether performance also increases if blood ketone levels are increased in the absence of ketoacidosis during high-intensity exercise.
METHODS


In a double-blind crossover design, fourteen well-trained male cyclists completed a 30-min time-trial (TT30') followed by an all-out sprint at 175% of lactate threshold (SPRINT). Subjects were randomized to receive either i) 50g ketone ester (KE), ii) 180 mg⋅kg body weight NaHCO3 (BIC), iii) KE+BIC or iv) a control drink (CON).
RESULTS


KE ingestion increased blood D-ß-hydroxybutyrate to ~3-4 mM during TT30' and SPRINT (p<0.001 vs. CON). In KE, blood pH and bicarbonate concomitantly dropped causing 0.05 units lower pH and 2.6 mM lower bicarbonate in KE compared to CON during TT30' and SPRINT (p<0.001 vs. CON). BIC co-ingestion resulted in 0.9 mM higher blood D-ß-hydroxybutyrate (p<0.001 vs. KE) and completely counteracted ketoacidosis during exercise (p>0.05 vs. CON). Mean power output during TT30' was similar between CON and BIC at 281W, but was 1.5% lower in the KE conditions (main effect of KE: p=0.03). Time-to-exhaustion in SPRINT was ~64s in CON and KE, and increased by ~8% in the BIC conditions (main effect of BIC: p<0.01).
DISCUSSION


Neutralization of acid-base disturbance by BIC co-ingestion is insufficient to counteract the slightly negative effect of KE intake during high-intensity exercise.",2020,BIC co-ingestion resulted in 0.9 mM higher blood D-ß-hydroxybutyrate (p<0.001 vs. KE) and completely counteracted ketoacidosis during exercise (p>0.05 vs. CON).,"['fourteen well-trained male cyclists', '50']","['oral ketone ester (KE) intake', 'g ketone ester (KE), ii) 180 mg⋅kg body weight NaHCO3 (BIC), iii', 'Bicarbonate Supplementation', 'control drink (CON']","['Mean power output during TT30', 'Time-to-exhaustion in SPRINT', 'blood ketone levels', 'blood pH and bicarbonate', 'blood D-ß-hydroxybutyrate']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C1271768', 'cui_str': 'Blood ketone level'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",,0.161,BIC co-ingestion resulted in 0.9 mM higher blood D-ß-hydroxybutyrate (p<0.001 vs. KE) and completely counteracted ketoacidosis during exercise (p>0.05 vs. CON).,"[{'ForeName': 'Chiel', 'Initials': 'C', 'LastName': 'Poffé', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Wyns', 'Affiliation': 'Bakala Academy-Athletic Performance Center, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ramaekers', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002552']
2062,33196667,Rate of decline in residual kidney function pre and post peritoneal dialysis initiation: A post hoc analysis of the IDEAL study.,"BACKGROUND


Residual kidney function (RKF) is associated with improved survival and quality of life in dialysis patients. Previous studies have suggested that initiation of peritoneal dialysis (PD) may slow RKF decline compared to the pre-dialysis period. We sought to evaluate the association between PD initiation and RKF decline in the Initiating Dialysis Early And Late (IDEAL) trial.
METHODS


In this post hoc analysis of the IDEAL randomized controlled trial, PD participants were included if results from 24-hour urine collections had been recorded within 30 days of dialysis initiation, and at least one value pre- and one value post-dialysis commencement were available. The primary outcome was slope of RKF decline, calculated as mean of urinary creatinine and urea clearances. Secondary outcomes included slope of urine volume decline and time from PD initiation to anuria.
RESULTS


The study included 151 participants (79 early start, 72 late start). The slope of RKF decline was slower after PD initiation (-2.69±0.18mL/min/1.73m2/yr) compared to before PD (-4.09±0.33mL/min/1.73m2/yr; change in slope +1.19 mL/min/1.73m2/yr, 95%CI 0.48-1.90, p<0.001). In contrast, urine volume decline was faster after PD commencement (-0.74±0.05 L/yr) compared to beforehand (-0.57±0.06L/yr; change in slope -0.18L/yr, 95%CI -0.34--0.01, p = 0.04). No differences were observed between the early- and late-start groups with respect to RKF decline, urine volume decline or time to anuria.
CONCLUSIONS


Initiation of PD was associated with a slower decline of RKF compared to the pre-dialysis period.",2020,"No differences were observed between the early- and late-start groups with respect to RKF decline, urine volume decline or time to anuria.
","['dialysis patients', '151 participants (79 early start, 72 late start']",[],"['RKF decline, urine volume decline or time to anuria', 'slope of RKF decline', 'urine volume decline', 'slope of urine volume decline and time from PD initiation to anuria', 'survival and quality of life', 'slope of RKF decline, calculated as mean of urinary creatinine and urea clearances']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",[],"[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003460', 'cui_str': 'Anuria'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}]",151.0,0.303324,"No differences were observed between the early- and late-start groups with respect to RKF decline, urine volume decline or time to anuria.
","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ethier', 'Affiliation': ""Division of Nephrology, Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Yeoungjee', 'Initials': 'Y', 'LastName': 'Cho', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Hawley', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Viecelli', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Campbell', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'van Eps', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Isbel', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Cooper', 'Affiliation': 'Department of Renal Medicine, Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Harris', 'Affiliation': 'Centre for Transplantation and Renal Research, Westmead Institute for Medical Research, Sydney, Australia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Pollock', 'Affiliation': 'Department of Renal Medicine, Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'Muh Geot', 'Initials': 'MG', 'LastName': 'Wong', 'Affiliation': 'Department of Renal Medicine, Royal North Shore Hospital, St Leonards, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.'}]",PloS one,['10.1371/journal.pone.0242254']
2063,33196737,Red Deer Umbilical Cord-Derived Stem Cell Conditioned Media Combined With Ablative Resurfacing of the Face.,"BACKGROUND


Laser resurfacing is the gold standard procedure for photodamage, but is not without downtime and risk. Use of periprocedural products containing stem cell conditioned media may improve results and optimize healing.
STUDY DESIGN


This was a prospective, randomized controlled, double-blind study, evaluating the efficacy and tolerability of red deer umbilical cord-derived stem cell conditioned media (USCCM) cream and serum pre- and post- ablative facial resurfacing.
METHODS AND MATERIALS


Twenty patients with moderate to severe photodamage were randomized to receive vehicle or USCCM cream and serum pre- and post- ablative resurfacing of the face. Blinded investigators rated healing, tolerability, and efficacy, while subjects rated post-procedure symptoms, tolerability, and satisfaction.
RESULTS


Both the active and vehicle pre-procedure cream were soothing, calming and easy to use by all patients. There was a trend towards decreased facial erythema and crusting in the active versus vehicle group. A greater improvement in wrinkling occurred in the active group. The majority of subjects were very satisfied with the active products. There were no serious adverse events.
CONCLUSION


Red deer umbilical cord-derived stem cell conditioned media (USCCM) is well tolerated, safe and efficacious for use pre- and post- facial laser resurfacing.J Drugs Dermatol. 2020;19(11): 1044-1048 doi:10.36849/JDD.2020.5246.",2020,"There were no serious adverse events.
",['Twenty patients with moderate to severe photodamage'],"['Laser resurfacing', 'Red deer umbilical cord-derived stem cell conditioned media (USCCM', 'Red Deer Umbilical Cord-Derived Stem Cell Conditioned Media Combined With Ablative Resurfacing of the Face', 'red deer umbilical cord-derived stem cell conditioned media (USCCM) cream and serum pre- and post- ablative facial resurfacing', 'vehicle or USCCM cream and serum pre- and post- ablative resurfacing of the face']","['tolerated, safe and efficacious', 'efficacy and tolerability', 'healing, tolerability, and efficacy, while subjects rated post-procedure symptoms, tolerability, and satisfaction', 'facial erythema and crusting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0325228', 'cui_str': 'Cervus elaphus'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0162518', 'cui_str': 'Conditioned Culture Medium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",20.0,0.15821,"There were no serious adverse events.
","[{'ForeName': 'Elika', 'Initials': 'E', 'LastName': 'Hoss', 'Affiliation': ''}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Kollipara', 'Affiliation': ''}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Alhaddad', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Boen', 'Affiliation': ''}, {'ForeName': 'Mitchel P', 'Initials': 'MP', 'LastName': 'Goldman', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5246']
2064,33196744,The Influence of Different Treatment Combinations on Skin Laxity and Dimpling.,"OBJECTIVE


The aim of the study was to identify the effectiveness of the combination of tissue stabilized guided subcision, microfocused ultrasound, and minimally invasive calcium hydroxylapatite injections in various sequences for treating skin surface irregularities of the buttocks and thighs.
MATERIAL AND METHODS


61 females (body mass index: 22.6 &plusmn; 2.4 kg/m&sup2;, age: 37.2 &plusmn; 6.8 years) were enrolled in this randomized interventional prospective study. Treatment arms included a variable combination and sequence of three treatment modalities: (1) Tissue-stabilized guided subcision, (2) microfocused ultrasound, and (3) calcium hydroxylapatite injections. Six months after the final intervention skin laxity and skin dimpling severity scores were assessed by the study participants, the treating physicians and by eleven blinded independent board-certified experts.
RESULTS


No adverse events were observed during the study that required intervention outside the standard of care treatment protocol. The combination of three treatment modalities was shown to provide greater improvement in skin laxity 1.88 (95% CI, 0.66&ndash;5.37) and skin dimpling 1.31 (95% CI, 0.61&ndash;2.81) scores as compared to any combination of two modalities. The combination of concomitant microfocused ultrasound and calcium hydroxylapatite injections followed three months later by tissue stabilized guided subcision yielded the greatest improvement in skin laxity 2.23 (95% CI, 0.51&ndash;9.82) and skin dimpling 1.79 (95% CI, 0.67&ndash;4.78) at 9-month follow-up.
CONCLUSION


This study provides evidence for the effectiveness of combination therapies for the improvement of skin surface irregularities on the buttocks and thighs. J Drugs Dermatol. 2020;19(11): 1030-1038. doi:10.36849/JDD.2020.5117.",2020,"The combination of three treatment modalities was shown to provide greater improvement in skin laxity 1.88 (95% CI, 0.66&ndash;5.37) and skin dimpling 1.31 (95% CI, 0.61&ndash;2.81) scores as compared to any combination of two modalities.","['61 females (body mass index: 22.6 &plusmn; 2.4 kg/m&sup2;, age: 37.2 &plusmn; 6.8 years']","['tissue stabilized guided subcision, microfocused ultrasound, and minimally invasive calcium hydroxylapatite injections', 'variable combination and sequence of three treatment modalities: (1) Tissue-stabilized guided subcision, (2) microfocused ultrasound, and (3) calcium hydroxylapatite injections']","['skin laxity', 'Skin Laxity and Dimpling', 'adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4761112', 'cui_str': 'Subcision'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010495', 'cui_str': 'Cutis laxa'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0325497,"The combination of three treatment modalities was shown to provide greater improvement in skin laxity 1.88 (95% CI, 0.66&ndash;5.37) and skin dimpling 1.31 (95% CI, 0.61&ndash;2.81) scores as compared to any combination of two modalities.","[{'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bartsch', 'Affiliation': ''}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Casabona', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sitzwohl', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': ''}, {'ForeName': 'Jeremy B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Stanger', 'Affiliation': ''}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Frank', 'Affiliation': ''}, {'ForeName': 'Emy C', 'Initials': 'EC', 'LastName': 'Onishi', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cotofana', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5117']
2065,33196752,Clinical Trial Evaluating the Long-Term Efficacy of Microfocused Ultrasound With Visualization for Décolleté Rejuvenation.,"Previous studies have demonstrated the beneficial effects of microfocused ultrasound with visualization (MFU-V) for treating chest wrinkles; however, those studies followed subjects for only 180 days. The objective of the following study was to assess the long-term effects of MFU-V for the treating chest wrinkles. Each subject was treated with 4-4.5 mm, 7-3.0 mm, and 10-1.5 mm transducers. Subjects were subsequently evaluated on post-treatment days 6, 12, 180, and 360. Digital images were obtained of the d&eacute;collet&eacute; area of each subject prior to treatment and at each follow-up evaluation. Wrinkle severity was assessed using the validated Merz D&eacute;colletage Wrinkle Scales at each follow-up visit and Subject Satisfaction Questionnaires were completed on post-treatment days 180 and 360. Enrolled subjects (N=20) were female with a mean (SD) age of 54.9 (7.5) years (range, 44 to 71 years). The study was completed by 15 subjects. Subjects achieved a significant decrease in dynamic wrinkle scores over time (P&lt;0.01). Baseline scores were significantly decreased at day 90 (P&le;0.01) which remained significant at days 180 and 360 (for each, P&lt;0.01). Subjects also showed significantly decreased at-rest wrinkle scores over time (P&le;0.01). Baseline scores were significantly decreased at day 90 (P&le;0.01), which remained significant at days 180 and 360 (for each, P=0.01). Mean (SD) subject satisfaction scores increased from 2.9 (1.8) on day 180 to 3.9 (1.8) on day 360.J Drugs Dermatol. 2020;19(11):1026-1029. doi:10.36849/JDD.2020.5265.",2020,Subjects also showed significantly decreased at-rest wrinkle scores over time (P&le;0.01).,"['15 subjects', 'Enrolled subjects (N=20) were female with a mean (SD) age of 54.9 (7.5) years (range, 44 to 71 years']","['Microfocused Ultrasound With Visualization for Décolleté Rejuvenation', 'MFU-V']","['Wrinkle severity', 'dynamic wrinkle scores', 'Mean (SD) subject satisfaction scores', 'Baseline scores', 'validated Merz D&eacute;colletage Wrinkle Scales', 'rest wrinkle scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",20.0,0.0297071,Subjects also showed significantly decreased at-rest wrinkle scores over time (P&le;0.01).,"[{'ForeName': 'Sabrina G', 'Initials': 'SG', 'LastName': 'Fabi', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Boen', 'Affiliation': ''}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Alhaddad', 'Affiliation': ''}, {'ForeName': 'Mitchel P', 'Initials': 'MP', 'LastName': 'Goldman', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5265']
2066,33196757,At-Home Transvaginal Device Following Fractional Carbon Dioxide Laser Treatment for Genitourinary Syndrome of Menopause.,"BACKGROUND


Device-based therapeutic approaches have been developed to treat women&rsquo;s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment.
OBJECTIVE


This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM).
STUDY DESIGN


Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser).
METHODS


10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms.
RESULTS


Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P&lt;0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P&lt;0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P&lt;0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P&lt;0.05).
CONCLUSIONS


At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012.",2020,SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P&lt;0.05).,"['Genitourinary Syndrome of Menopause', 'Subjects completing 12-month follow-up after three', 'genitourinary syndrome of menopause (GSM', '10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM']","['FxCO2 laser treatment', 'Fractional Carbon Dioxide Laser Treatment', 'fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser', 'home transvaginal red and infrared light device', 'Fractional carbon dioxide laser resurfacing (FxCO2']","['Mean subject satisfaction', 'Vulvovaginal symptoms measured by VAS', 'VAS symptoms', 'vulvovaginal and SUI symptoms', 'vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms', 'SUI symptoms']","[{'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]",,0.0667094,SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P&lt;0.05).,"[{'ForeName': 'Macrene', 'Initials': 'M', 'LastName': 'Alexiades', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.1012']
2067,33196739,Prevention of Scarring With Intraoperative Erbium: YAG Laser Treatment.,"BACKGROUND


Scars can develop as a result of surgical incisions and pose psychological, cosmetic, and physical stress to the patients affected. Lasers have been used for scar revision, but little information exists regarding intraoperative use and efficacy.
OBJECTIVE


To evaluate a 2,940-nm fractional erbium:YAG laser to improve scar appearance when used immediately after skin closure.
METHODS AND MATERIALS


Patients undergoing complex closures of at least 1.5 cm in length were recruited. Half of the wound received treatment with 2,940 erbium:YAG laser immediately after skin closure. Follow up occurred at 1 week and 12 weeks, postoperatively. Patient self-assessment was performed at the final visit. Photographs were evaluated by three blinded dermatologic surgeons.
RESULTS


18 patients completed the treatment protocol and follow-up. 61.1% of patients reported that the treated side was cosmetically superior to the control side. A majority of patients said the treated side was superior in elevation, erythema, and similarity to normal skin. Physician evaluation showed that the treated half was cosmetically superior in 12 of 18 patients (66.7%).
CONCLUSIONS


This study demonstrates that a 2,940-nm erbium:YAG laser treatment, performed immediately after surgery, can improve the appearance of a surgical scar. J Drugs Dermatol. 2020;19(11): 1040-1043. doi:10.36849/JDD.2020.5244.",2020,"Physician evaluation showed that the treated half was cosmetically superior in 12 of 18 patients (66.7%).
",['Patients undergoing complex closures of at least 1.5 cm in length were recruited'],"['2,940-nm fractional erbium:YAG laser', '2,940-nm erbium:YAG laser treatment', '2,940 erbium:YAG laser']",['scar appearance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",,0.013417,"Physician evaluation showed that the treated half was cosmetically superior in 12 of 18 patients (66.7%).
","[{'ForeName': 'Hiren', 'Initials': 'H', 'LastName': 'Kolli', 'Affiliation': ''}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Moy', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849/JDD.2020.5244']
2068,33196773,Effect of Antibiotic Use Within First 48 Hours of Life on the Preterm Infant Microbiome: A Randomized Clinical Trial.,,2020,,[],['Antibiotic Use'],[],[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",[],,0.176522,,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Grady', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Derrick', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Yueyue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Oliphant', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Erika C', 'Initials': 'EC', 'LastName': 'Claud', 'Affiliation': 'Neonatology, Department of Pediatrics, University of Chicago, Chicago, Illinois.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.4916']
2069,33196779,Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis.,"BACKGROUND


Depression, fatigue, and pain commonly co-occur in multiple sclerosis (MS) and are positively associated with one another. However, it is unclear whether treatment-related improvement in one of these symptoms is associated with improvements in the other two symptoms.
PURPOSE


This study examined whether early improvements in depressive symptoms, fatigue impact, and pain interference during a multisymptom intervention in persons with MS were associated with overall improvements in the other two symptoms.
METHODS


Secondary analysis of a randomized controlled trial in which both treatments improved depressive symptoms, fatigue, and pain interference. Adults with MS experiencing chronic pain, chronic fatigue, and/or moderate depressive symptoms (N = 154, 86% women) participated in an 8-week, telephone-delivered intervention: self-management (n = 69) or education (n = 85); intervention groups were combined for the current study. Outcome measures were depressive symptoms (PHQ-9), fatigue impact (Modified Fatigue Impact Scale), and pain interference (Brief Pain Inventory). Path analysis examined associations between pre-to-mid intervention improvement in one symptom (i.e., depression, fatigue, pain interference) and pre-to-post (overall) improvement in the other two symptoms.
RESULTS


Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p's < .01). Early reduction in fatigue impact was associated with an overall reduction in depressive symptom severity (p = .04) but not pain interference. Early reduction in pain interference was not associated with reductions in fatigue impact or depressive symptoms.
CONCLUSIONS


These findings suggest the potential importance of reducing depressive symptoms to overall improvement in fatigue and pain interference in persons with MS.
CLINICAL TRIAL REGISTRATIONS


NCT00944190.",2020,Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p's < .01).,"['persons with MS', 'Adults with MS experiencing chronic pain, chronic fatigue, and/or moderate depressive symptoms (N = 154, 86% women) participated in an 8-week', 'Adults With Multiple Sclerosis']",['telephone-delivered intervention: self-management (n = 69) or education'],"['depressive symptom severity', 'depressive symptoms (PHQ-9), fatigue impact (Modified Fatigue Impact Scale), and pain interference (Brief Pain Inventory', 'fatigue impact or depressive symptoms', 'depressive symptoms, fatigue, and pain interference', 'Fatigue Impact and Pain Interference', 'fatigue impact', 'fatigue and pain interference', 'depressive symptoms, fatigue impact, and pain interference', 'pain interference and fatigue impact', 'depressive symptoms', 'pain interference', 'one symptom (i.e., depression, fatigue, pain interference) and pre-to-post (overall) improvement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",154.0,0.0861724,Early reduction in depressive symptoms was associated with an overall reduction in pain interference and fatigue impact (p's < .01).,"[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Knowles', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Arewasikporn', 'Affiliation': 'Department of Epidemiology, University of Washington School of Public Health, Seattle, WA, USA.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Kratz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Turner', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa102']
2070,33196797,Effect of School-Based Body Mass Index Reporting in California Public Schools: A Randomized Clinical Trial.,"Importance


Annually, US schools screen millions of students' body mass index (BMI) and report the results to parents, with little experimental evidence on potential benefits and harms.
Objective


To determine the impact of school-based BMI reporting on weight status and adverse outcomes (weight stigmatization and weight-related perceptions and behaviors) among a diverse student population.
Design, Setting, and Participants


Cluster randomized clinical trial. The Fit Study (2014-2017) randomized 79 California schools to BMI screening and reporting (group 1), BMI screening only (group 2), or control (no BMI screening or reporting [group 3]) in grades 3 to 8. The setting was California elementary and middle schools. Students in grades 3 to 7 at baseline participated for up to 3 years. A modified intent-to-treat protocol was used. Data analysis was conducted from April 13, 2017, to March 26, 2020.
Interventions


School staff assessed BMI each spring among students in groups 1 and 2. Parents of students in group 1 were sent a BMI report each fall for up to 2 years.
Main Outcomes and Measures


Changes in BMI z score and in adverse outcomes (based on surveys conducted each fall among students in grades 4 to 8) from baseline to 1 and 2 years of follow-up.
Results


A total of 28 641 students (14 645 [51.1%] male) in grades 3 to 7 at baseline participated in the study for up to 3 years. Among 6534 of 16 622 students with a baseline BMI in the 85th percentile or higher (39.3%), BMI reporting had no effect on BMI z score change (-0.003; 95% CI, -0.02 to 0.01 at 1 year and 0.01; 95% CI, -0.02 to 0.03 at 2 years). Weight dissatisfaction increased more among students having BMI screened at school (8694 students in groups 1 and 2) than among control participants (5674 students in group 3). Results of the effect of BMI reporting on other adverse outcomes were mixed: compared with the control (group 3), among students weighed at school (groups 1 and 2), weight satisfaction declined more after 2 years (-0.11; 95% CI, -0.18 to -0.05), and peer weight talk increased more after 1 year (0.05; 95% CI, 0.01-0.09); however, concerning weight control behaviors declined more after 1 year (-0.06; 95% CI, -0.10 to -0.02).
Conclusions and Relevance


Body mass index reports alone do not improve children's weight status and may decrease weight satisfaction. To improve student health, schools should consider investing resources in evidence-based interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT02088086.",2020,Weight dissatisfaction increased more among students having BMI screened at school (8694 students in groups 1 and 2) than among control participants (5674 students in group 3).,"['6534 of 16 622 students with a', 'Data analysis was conducted from April 13, 2017, to March 26, 2020', 'Students in grades 3 to 7 at baseline participated for up to 3 years', 'students having BMI screened at school (8694 students in groups 1 and 2) than among control participants (5674 students in group 3', 'A total of 28 641 students (14 645 [51.1%] male) in grades 3 to 7 at baseline participated in the study for up to 3 years', 'diverse student population', 'California Public Schools']","['School-Based Body Mass Index Reporting', 'California schools to BMI screening and reporting (group 1), BMI screening only (group 2), or control (no BMI screening or reporting [group 3]) in grades 3 to 8']","['peer weight talk', 'BMI z score change', 'BMI z score and in adverse outcomes', 'baseline BMI', 'weight satisfaction', 'weight status and adverse outcomes (weight stigmatization and weight-related perceptions and behaviors', 'weight control behaviors', 'Weight dissatisfaction']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0557800', 'cui_str': 'Public school'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038330', 'cui_str': 'Stigmatization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}]",79.0,0.0964542,Weight dissatisfaction increased more among students having BMI screened at school (8694 students in groups 1 and 2) than among control participants (5674 students in group 3).,"[{'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Madsen', 'Affiliation': 'Berkeley Food Institute, University of California, Berkeley, Berkeley.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Thompson', 'Affiliation': 'Community Health Sciences, School of Public Health, University of California, Berkeley, Berkeley.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Linchey', 'Affiliation': 'Community Health Sciences, School of Public Health, University of California, Berkeley, Berkeley.'}, {'ForeName': 'Lorrene D', 'Initials': 'LD', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, Division of Agriculture and Natural Resources, University of California, Oakland.'}, {'ForeName': 'Shalika', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Community Health Sciences, School of Public Health, University of California, Berkeley, Berkeley.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Neumark-Sztainer', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'Patricia B', 'Initials': 'PB', 'LastName': 'Crawford', 'Affiliation': 'Nutrition Policy Institute, Division of Agriculture and Natural Resources, University of California, Oakland.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'McCulloch', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ibarra-Castro', 'Affiliation': 'Community Health Sciences, School of Public Health, University of California, Berkeley, Berkeley.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.4768']
2071,33196806,Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of Cluster Randomized Clinical Trials.,"Importance


Saline (0.9% sodium chloride), the fluid most commonly used to treat diabetic ketoacidosis (DKA), can cause hyperchloremic metabolic acidosis. Balanced crystalloids, an alternative class of fluids for volume expansion, do not cause acidosis and, therefore, may lead to faster resolution of DKA than saline.
Objective


To compare the clinical effects of balanced crystalloids with the clinical effects of saline for the acute treatment of adults with DKA.
Design, Setting, and Participants


This study was a subgroup analysis of adults with DKA in 2 previously reported companion trials-Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department (SALT-ED) and the Isotonic Solutions and Major Adverse Renal Events Trial (SMART). These trials, conducted between January 2016 and March 2017 in an academic medical center in the US, were pragmatic, multiple-crossover, cluster, randomized clinical trials comparing balanced crystalloids vs saline in emergency department (ED) and intensive care unit (ICU) patients. This study included adults who presented to the ED with DKA, defined as a clinical diagnosis of DKA, plasma glucose greater than 250 mg/dL, plasma bicarbonate less than or equal to 18 mmol/L, and anion gap greater than 10 mmol/L. Data analysis was performed from January to April 2020.
Interventions


Balanced crystalloids (clinician's choice of Ringer lactate solution or Plasma-Lyte A solution) vs saline for fluid administration in the ED and ICU according to the same cluster-randomized multiple-crossover schedule.
Main Outcomes and Measures


The primary outcome was time between ED presentation and DKA resolution, as defined by American Diabetes Association criteria. The secondary outcome was time between initiation and discontinuation of continuous insulin infusion.
Results


Among 172 adults included in this secondary analysis of cluster trials, 94 were assigned to balanced crystalloids and 78 to saline. The median (interquartile range [IQR]) age was 29 (24-45) years, and 90 (52.3%) were women. The median (IQR) volume of isotonic fluid administered in the ED and ICU was 4478 (3000-6372) mL. Cumulative incidence analysis revealed shorter time to DKA resolution in the balanced crystalloids group (median time to resolution: 13.0 hours; IQR: 9.5-18.8 hours) than the saline group (median: 16.9 hours; IQR: 11.9-34.5 hours) (adjusted hazard ratio [aHR] = 1.68; 95% CI, 1.18-2.38; P = .004). Cumulative incidence analysis also revealed shorter time to insulin infusion discontinuation in the balanced crystalloids group (median: 9.8 hours; IQR: 5.1-17.0 hours) than the saline group (median: 13.4 hours; IQR: 11.0-17.9 hours) (aHR = 1.45; 95% CI, 1.03-2.03; P = .03).
Conclusions and Relevance


In this secondary analysis of 2 cluster randomized clinical trials, compared with saline, treatment with balanced crystalloids resulted in more rapid resolution of DKA, suggesting that balanced crystalloids may be preferred over saline for acute management of adults with DKA.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02614040; NCT02444988.",2020,"Cumulative incidence analysis also revealed shorter time to insulin infusion discontinuation in the balanced crystalloids group (median: 9.8 hours; IQR: 5.1-17.0 hours) than the saline group (median: 13.4 hours; IQR: 11.0-17.9 hours) (aHR = 1.45; 95% CI, 1.03-2.03; P = .03).
","['Adults With Diabetic Ketoacidosis', 'January 2016 and March 2017 in an academic medical center in the US', 'adults with DKA in 2 previously reported companion trials', 'adults with DKA', 'in emergency department (ED) and intensive care unit (ICU) patients', 'adults who presented to the ED with DKA, defined as a clinical diagnosis of DKA, plasma glucose greater than 250 mg/dL, plasma bicarbonate less than or equal to 18 mmol/L, and anion gap greater than 10 mmol/L. Data analysis was performed from January to April 2020', '172 adults included in this secondary analysis of cluster trials, 94 were assigned to']","['balanced crystalloids', 'Ringer lactate solution or Plasma-Lyte A solution) vs saline', 'balanced crystalloids and 78 to saline', 'balanced crystalloids vs saline', ""Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department (SALT-ED"", 'saline', 'Importance\n\n\nSaline (0.9% sodium chloride', 'Balanced Crystalloids vs Saline']","['rapid resolution of DKA', 'median (IQR) volume of isotonic fluid', 'time to DKA resolution', 'time between ED presentation and DKA resolution, as defined by American Diabetes Association criteria', 'time between initiation and discontinuation of continuous insulin infusion', 'shorter time to insulin infusion discontinuation']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0858075', 'cui_str': 'Plasma bicarbonate'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0003074', 'cui_str': 'Anion gap'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0071213', 'cui_str': 'Plasmalyte A'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0990166', 'cui_str': 'Sodium Chloride 0.154 MEQ/ML'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",2.0,0.44977,"Cumulative incidence analysis also revealed shorter time to insulin infusion discontinuation in the balanced crystalloids group (median: 9.8 hours; IQR: 5.1-17.0 hours) than the saline group (median: 13.4 hours; IQR: 11.0-17.9 hours) (aHR = 1.45; 95% CI, 1.03-2.03; P = .03).
","[{'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Evans', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Jenkins', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Brown', 'Affiliation': 'Asheville Pulmonary and Critical Care Associates, Asheville, North Carolina.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Taylor D', 'Initials': 'TD', 'LastName': 'Coston', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Felbinger', 'Affiliation': 'Department of Pharmacy Services, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Lisa N', 'Initials': 'LN', 'LastName': 'Flemmons', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Hellervik', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'McCoin', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Niswender', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Corey M', 'Initials': 'CM', 'LastName': 'Slovis', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'Department of Pharmacy Services, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.24596']
2072,33196927,"Effectiveness of a brief psychoeducational intervention on postnatal depression in the slums, Nairobi: a longitudinal study.","Research has shown that postnatal depression (PND) is higher in low- and middle-income countries as compared to higher-income countries. Despite this, little is known about practical interventions in these poorly resourced countries. This research investigated the effectiveness of a brief, prophylactic and therapeutic psychoeducational intervention in a low-resourced community in Nairobi. Two closely similar Maternal and Child Health (MCH) clinics in urban slums in Nairobi were identified and randomly selected. A total of 567 mothers formed the study population. The experimental group (284) mothers received the intervention, which included psychoeducation on PND, coping skills, healthy way of mother/child interaction and infant stimulation in addition to routine treatment, while the control group (283) mothers received treatment as usual. Data was collected using a social-demographic questionnaire and the English version of Becks Depression Inventory (BDI) at baseline. At 6 months, we reassessed both groups using BDI only. Within group comparison, the percentage reduction of depression was 35.6% among the experimental as compared to 2.3% in the control group. Between group comparison, the mean BDI depression score was significantly low in the experimental arm compared to the control arm at endline (p = 0.025). When all variables were adjusted, using a generalized linear model, BDI depression score reduction among the participants was significantly associated with the intervention (p = 0.040). A brief, psychoeducational intervention that targets the mother and her infant may reduce PND even in poorly resourced environments. Therefore, it can be integrated into existing MCH services.",2020,"Between group comparison, the mean BDI depression score was significantly low in the experimental arm compared to the control arm at endline (p = 0.025).","['567 mothers formed the study population', 'Two closely similar Maternal and Child Health (MCH) clinics in urban slums in Nairobi', 'a low-resourced community in Nairobi']","['prophylactic and therapeutic psychoeducational intervention', 'intervention, which included psychoeducation on PND, coping skills, healthy way of mother/child interaction and infant stimulation in addition to routine treatment, while the control group (283) mothers received treatment as usual', 'psychoeducational intervention']","['mean BDI depression score', 'social-demographic questionnaire and the English version of Becks Depression Inventory (BDI', 'generalized linear model, BDI depression score reduction', 'percentage reduction of depression', 'postnatal depression']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0023732', 'cui_str': 'Models, Linear'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",567.0,0.0313474,"Between group comparison, the mean BDI depression score was significantly low in the experimental arm compared to the control arm at endline (p = 0.025).","[{'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'Kariuki', 'Affiliation': 'Department of Psychiatry, School of Medicine, The University of Nairobi, P.O. Box 30197, Nairobi, 00100, Kenya. kariukiesther@yahoo.com.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Kuria', 'Affiliation': 'Department of Psychiatry, School of Medicine, The University of Nairobi, P.O. Box 30197, Nairobi, 00100, Kenya.'}, {'ForeName': 'Fredrick N', 'Initials': 'FN', 'LastName': 'Were', 'Affiliation': 'Department of Psychiatry, School of Medicine, The University of Nairobi, P.O. Box 30197, Nairobi, 00100, Kenya.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Ndetei', 'Affiliation': 'Department of Psychiatry, School of Medicine, The University of Nairobi, P.O. Box 30197, Nairobi, 00100, Kenya.'}]",Archives of women's mental health,['10.1007/s00737-020-01085-1']
2073,33196931,Wielding a gun increases judgments of others as holding guns: a randomized controlled trial.,"The gun embodiment effect is the consequence caused by wielding a gun on judgments of whether others are also holding a gun. This effect could be responsible for real-world instances when police officers shoot an unarmed person because of the misperception that the person had a gun. The gun embodiment effect is an instance of embodied cognition for which a person's tool-augmented body affects their judgments. The replication crisis in psychology has raised concern about embodied cognition effects in particular, and the issue of low statistical power applies to the original research on the gun embodiment effect. Thus, the first step was to conduct a high-powered replication. We found a significant gun embodiment effect in participants' reaction times and in their proportion of correct responses, but not in signal detection measures of bias, as had been originally reported. To help prevent the gun embodiment effect from leading to fatal encounters, it would be useful to know whether individuals with certain traits are less prone to the effect and whether certain kinds of experiences help alleviate the effect. With the new and reliable measure of the gun embodiment effect, we tested for moderation by individual differences related to prior gun experience, attitudes, personality, and factors related to emotion regulation and impulsivity. Despite the variety of these measures, there was little evidence for moderation. The results were more consistent with the idea of the gun embodiment effect being a universal, fixed effect, than being a flexible, malleable effect.",2020,"We found a significant gun embodiment effect in participants' reaction times and in their proportion of correct responses, but not in signal detection measures of bias, as had been originally reported.",[],[],[],[],[],[],,0.0260932,"We found a significant gun embodiment effect in participants' reaction times and in their proportion of correct responses, but not in signal detection measures of bias, as had been originally reported.","[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Witt', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, 80523, USA. Jessica.Witt@colostate.edu.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Parnes', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Nathan L', 'Initials': 'NL', 'LastName': 'Tenhundfeld', 'Affiliation': 'University of Alabama in Huntsville, Huntsville, AL, USA.'}]",Cognitive research: principles and implications,['10.1186/s41235-020-00260-3']
2074,33196937,HIV-Risk Behavior Among Adults with Opioid Use Disorder During 12 Months Following Pre-trial Detention: Results from a Randomized Trial of Methadone Treatment.,"This was a three group randomized clinical trial of interim methadone and patient navigation involving 225 pre-trial detainees with opioid use disorder in Baltimore. The HIV Risk Assessment Battery (RAB) was administered at baseline (in jail), and at 6 and 12 months post-release. Generalized linear mixed model analyses indicated the condition × time interaction effect failed to reach significance (ps > .05) for both the drug risk and sex risk subscale scores. Therefore, findings suggest that there were no intervention effects on drug or sex risk behaviors. However, increased use of cocaine at baseline was associated with increases in drug- (b = .04, SE = .02) and sex-risk (b = .01, SE = .003) behaviors. These results suggest that interventions targeting cocaine use among pre-trial detainees may serve as a means of reducing HIV risk associated with drug- and sex-risk behaviors.Clinical Trials Registration: Clinicaltrials.gov NCT02334215.",2020,Generalized linear mixed model analyses indicated the condition × time interaction effect failed to reach significance (ps > .05) for both the drug risk and sex risk subscale scores.,"['Adults with Opioid Use Disorder', 'involving 225 pre-trial detainees with opioid use disorder in Baltimore']","['Methadone', 'methadone and patient navigation']","['HIV Risk Assessment Battery (RAB', 'drug or sex risk behaviors', 'drug risk and sex risk subscale scores', 'sex-risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",225.0,0.101528,Generalized linear mixed model analyses indicated the condition × time interaction effect failed to reach significance (ps > .05) for both the drug risk and sex risk subscale scores.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201, USA. mmitchell@friendsresearch.org.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Jaffe', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201, USA.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03090-y']
2075,33197076,Impacts of the COVID2019 pandemic on functional dyspepsia and irritable bowel syndrome: A population-based survey.,"BACKGROUND


Functional gastrointestinal disorders (FGIDs) are a group of stress-sensitive gut-brain disorders. The COVID-19 outbreak has caused immense stress and anxiety among the general public. Strict measures to counter COVID-19 emergency, including physical distancing have also taken a toll on physical and mental health. We investigated the impact of the COVID-19 pandemic on the gastrointestinal and psychological symptoms of functional dyspepsia (FD) and irritable bowel syndrome (IBS).
METHODS


An online survey was conducted in Japan for a group of randomly assigned panelists from May 26 to 27, 2020. Each respondent answered a questionnaire on stress, physical distancing, and worries about COVID-19. Gastrointestinal symptoms were assessed to diagnose FD and IBS (Rome III), and psychological symptoms were assessed using the Hospital Anxiety and Depression Scale.
RESULTS


A total of 5157 subjects were finally enrolled, with FD in 8.5%, IBS in 16.6%, and FD-IBS overlap in 4.0%. For both gastrointestinal and psychological symptoms, respondents with FD-IBS overlap showed the worst scores, followed by IBS-alone, then FD-alone respondents. During the COVID-19 pandemic, 11.9% of respondents reported deterioration and 2.8% reported improvement of gastrointestinal symptoms. FD-IBS overlap, psychological disease comorbidity, and stress at work/school were significantly associated with symptom deterioration. Younger age, commuting by public transport, and work/study from home were associated with symptom improvement.
CONCLUSIONS


The COVID-19 pandemic negatively affected FD/IBS subjects, with respondents showing FD-IBS overlap syndrome as the most important independent factor associated with deterioration in gastrointestinal symptoms. Physicians need to take extra care of FD/IBS patients in the post-COVID period.",2020,"During the COVID-19 pandemic, 11.9% of respondents reported deterioration and 2.8% reported improvement of gastrointestinal symptoms.","['functional dyspepsia and irritable bowel syndrome', 'A total of 5157 subjects were finally enrolled, with FD in 8.5%, IBS in 16.6%, and FD-IBS overlap in 4.0', 'An online survey was conducted in Japan for a group of randomly assigned panelists from May 26 to 27, 2020']",['COVID2019 pandemic'],"['Hospital Anxiety and Depression Scale', 'gastrointestinal symptoms', 'FD-IBS overlap, psychological disease comorbidity, and stress at work/school', 'functional dyspepsia (FD) and irritable bowel syndrome (IBS', 'Gastrointestinal symptoms', 'diagnose FD and IBS (Rome III), and psychological symptoms']","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0558919', 'cui_str': 'Stress at work'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",5157.0,0.0258602,"During the COVID-19 pandemic, 11.9% of respondents reported deterioration and 2.8% reported improvement of gastrointestinal symptoms.","[{'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kewin Tien Ho', 'Initials': 'KTH', 'LastName': 'Siah', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, The National University of Singapore, Singapore.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Yoshimoto', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Fukui', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15346']
2076,33197078,"Safety, Pharmacokinetics and Pharmacodynamics of SBT-020 in Patients with Early Stage Huntington's Disease, a two-part study.","INTRODUCTION


Huntington's disease (HD) is a neurodegenerative disease with cognitive, motor and psychiatric symptoms. Toxic accumulation of misfolded mutant huntingtin protein induces mitochondrial dysfunction, leading to a bioenergetic insufficiency in neuronal and muscle cells. We evaluated the safety, pharmacokinetics and pharmacodynamics of SBT-020, a novel compound to improve mitochondrial function, in a two-part study in early stage HD patients.
METHODS


Part 1 consisted of 7-day multiple ascending dose study to select the highest tolerable dose for Part 2, a 28-day multiple dose study. Mitochondrial function was measured in the visual cortex and calf muscle, using phosphorous magnetic resonance spectroscopy, and in circulating peripheral blood mononuclear cells (PBMCs).
RESULTS


Treatment-emergent adverse events were mild and more present in the SBT-020 group. Injection site reactions occurred in 91% in Part 1 and 97% in Part 2. Mitochondrial function in calf muscle, PBMCs or visual cortex was not changed overall due to treatment with SBT-020. In a post hoc analysis, patients with a higher degree of mitochondrial dysfunction (below the median (∆Ψ m  < 3412 and τPCr > 42.5 s)) showed more improvement than patients with a relatively lower level of mitochondrial dysfunction.
DISCUSSION


SBT-020 was safe at all doses, but no significant differences in any of the pharmacodynamic measurements between the treatment groups and placebo group could be demonstrated. The data suggest that the better than expected mitochondrial function in our patient population at baseline might explain the lack of effect of SBT-020.",2020,"Mitochondrial function in calf muscle, PBMCs or visual cortex was not changed overall due to treatment with SBT-020.","[""Patients with Early Stage Huntington's Disease, a two-part study"", 'early stage HD patients']","['placebo', 'SBT-020']","['Mitochondrial function', 'pharmacodynamic measurements', 'circulating peripheral blood mononuclear cells (PBMCs', 'mitochondrial dysfunction', 'Safety, Pharmacokinetics and Pharmacodynamics', 'Mitochondrial function in calf muscle, PBMCs or visual cortex', 'Injection site reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036782', 'cui_str': 'Serum bactericidal titer test'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",,0.023988,"Mitochondrial function in calf muscle, PBMCs or visual cortex was not changed overall due to treatment with SBT-020.","[{'ForeName': 'Marcus P J', 'Initials': 'MPJ', 'LastName': 'van Diemen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Ellen P', 'Initials': 'EP', 'LastName': 'Hart', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Abbruscato', 'Affiliation': 'Stealth BioTherapeutics Inc., Newton, Massachusetts.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Mead', 'Affiliation': 'Stealth BioTherapeutics Inc., Newton, Massachusetts.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'van Beelen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Sandrin C', 'Initials': 'SC', 'LastName': 'Bergheanu', 'Affiliation': 'Stealth BioTherapeutics Inc., Newton, Massachusetts.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Hameeteman', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Coppen', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jessica Y', 'Initials': 'JY', 'LastName': 'Winder', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Hermien', 'Initials': 'H', 'LastName': 'Kan', 'Affiliation': 'Gorter Centre for high-field MRI, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van der Grond', 'Affiliation': 'Radiology Research Center, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Gorter Centre for high-field MRI, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Raymund A C', 'Initials': 'RAC', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Geert Jan', 'Initials': 'GJ', 'LastName': 'Groeneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14656']
2077,33197158,Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation.,"BACKGROUND


In patients with symptomatic paroxysmal atrial fibrillation that has not responded to medication, catheter ablation is more effective than antiarrhythmic drug therapy for maintaining sinus rhythm. However, the safety and efficacy of cryoballoon ablation as initial first-line therapy have not been established.
METHODS


We performed a multicenter trial in which patients 18 to 80 years of age who had paroxysmal atrial fibrillation for which they had not previously received rhythm-control therapy were randomly assigned (1:1) to receive treatment with antiarrhythmic drugs (class I or III agents) or pulmonary vein isolation with a cryoballoon. Arrhythmia monitoring included 12-lead electrocardiography conducted at baseline and at 1, 3, 6, and 12 months; patient-activated telephone monitoring conducted weekly and when symptoms were present during months 3 through 12; and 24-hour ambulatory monitoring conducted at 6 and 12 months. The primary efficacy end point was treatment success (defined as freedom from initial failure of the procedure or atrial arrhythmia recurrence after a 90-day blanking period to allow recovery from the procedure or drug dose adjustment, evaluated in a Kaplan-Meier analysis). The primary safety end point was assessed in the ablation group only and was a composite of several procedure-related and cryoballoon system-related serious adverse events.
RESULTS


Of the 203 participants who underwent randomization and received treatment, 104 underwent ablation, and 99 initially received drug therapy. In the ablation group, initial success of the procedure was achieved in 97% of patients. The Kaplan-Meier estimate of the percentage of patients with treatment success at 12 months was 74.6% (95% confidence interval [CI], 65.0 to 82.0) in the ablation group and 45.0% (95% CI, 34.6 to 54.7) in the drug-therapy group (P<0.001 by log-rank test). Two primary safety end-point events occurred in the ablation group (Kaplan-Meier estimate of the percentage of patients with an event within 12 months, 1.9%; 95% CI, 0.5 to 7.5).
CONCLUSIONS


Cryoballoon ablation as initial therapy was superior to drug therapy for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation. Serious procedure-related adverse events were uncommon. (Supported by Medtronic; STOP AF First ClinicalTrials.gov number, NCT03118518.).",2020,Serious procedure-related adverse events were uncommon.,"['patients with symptomatic paroxysmal atrial fibrillation', 'patients with paroxysmal atrial fibrillation', '203 participants who underwent randomization and received treatment, 104 underwent ablation, and 99 initially received drug therapy', 'patients 18 to 80 years of age who had paroxysmal atrial fibrillation for which they had not previously received rhythm-control therapy']","['Cryoballoon Ablation', 'antiarrhythmic drugs (class I or III agents) or pulmonary vein isolation with a cryoballoon', 'Cryoballoon ablation']","['treatment success (defined as freedom from initial failure of the procedure or atrial arrhythmia recurrence', 'ablation group (Kaplan-Meier estimate of the percentage of patients with an event', 'atrial arrhythmia recurrence', 'safety and efficacy', 'composite of several procedure-related and cryoballoon system-related serious adverse events', 'initial success of the procedure', 'safety end-point events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444930', 'cui_str': 'End'}]",203.0,0.0490064,Serious procedure-related adverse events were uncommon.,"[{'ForeName': 'Oussama M', 'Initials': 'OM', 'LastName': 'Wazni', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Gopi', 'Initials': 'G', 'LastName': 'Dandamudi', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Nitesh', 'Initials': 'N', 'LastName': 'Sood', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hoyt', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Jaret', 'Initials': 'J', 'LastName': 'Tyler', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Sarfraz', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Niebauer', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Makati', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Halperin', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Gauri', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Morales', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Mingyuan', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Cerkvenik', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Rachelle E', 'Initials': 'RE', 'LastName': 'Kaplon', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'From Cleveland Clinic, Cleveland (O.M.W., M.N., M.S., S.E.N.), and Ohio State University Medical Center, Columbus (J.T.); CHI Franciscan, Tacoma, WA (G.D.); Southcoast Health System, Fall River, MA (N.S.); Iowa Heart Center, West Des Moines (R.H.); MedStar Heart and Vascular Institute, Washington, DC (S.D.); BayCare Medical Group, Tampa, FL (K.M.); Providence Saint Vincent, Portland, OR (B.H.); Spectrum Health Heart and Vascular, Grand Rapids, MI (A.G.); Grandview Medical Center, Birmingham, AL (G.M.); and Medtronic, Mounds View, MN (J.C., R.E.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029554']
2078,33199437,Nucleus basalis of meynert stimulation for lewy body dementia: A phase I randomized clinical trial.,"OBJECTIVES


Nucleus basalis of Meynert deep brain stimulation (NBM-DBS) has been proposed for patients with dementia. Here, we aim to assess the safety and effects of NBM-DBS in patients with Lewy-body dementia (LBD), in a randomized, double-blind and crossover clinical trial.
METHODS


Six patients with mild to moderate LBD (mean [SD] age, 62.2 [7.8] years) were included and operated for bilateral NBM-DBS, and assigned to receive either active or sham NBM-DBS, followed by the opposite condition for 3 months. The primary outcome was the difference in the total free recalls of the Free and Cued Selective Reminding Test (FCSRT) between active  versus  sham NBM-DBS. Secondary outcomes were assessments of the safety and effects of NBM-DBS on cognition, motor disability, sleep and PET imaging.
RESULTS


There was no significant difference in the FCSRT with active  versus  sham NBM-DBS. The surgical procedures were well tolerated in all patients, but we observed significant decreases in Stroop and Benton scores after electrode implantation. We observed no significant difference in other scales between active  versus  sham NBM-DBS. With active NBM-DBS relative to baseline, phonemic fluency and motor disability significantly decreased. Lastly, the superior lingual gyrus metabolic activity significantly increased with active NBM-DBS.
CONCLUSIONS


NBM-DBS does not appear to be totally safe for LBD patients with no evidence of cognitive benefit.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with LBD operated for bilateral NBM-DBS, active NBM-DBS stimulation compared to sham stimulation did not significantly change selective recall scores.",2020,"The surgical procedures were well tolerated in all patients, but we observed significant decreases in Stroop and Benton scores after electrode implantation.","['patients with dementia', 'patients with Lewy-body dementia (LBD', 'LBD patients with no evidence of cognitive benefit', 'patients with LBD', 'lewy body dementia', 'Six patients with mild to moderate LBD (mean [SD] age, 62.2 [7.8] years) were included and operated for bilateral NBM-DBS']","['NBM-DBS', 'active or sham NBM-DBS', 'Meynert deep brain stimulation (NBM-DBS']","['phonemic fluency and motor disability', 'total free recalls of the Free and Cued Selective Reminding Test (FCSRT', 'Stroop and Benton scores', 'safety and effects of NBM-DBS on cognition, motor disability, sleep and PET imaging', 'superior lingual gyrus metabolic activity', 'selective recall scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",6.0,0.517424,"The surgical procedures were well tolerated in all patients, but we observed significant decreases in Stroop and Benton scores after electrode implantation.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maltête', 'Affiliation': 'Department of Neurology, Rouen University Hospital and University of Rouen, France david.maltete@chu-rouen.fr.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wallon', 'Affiliation': 'Department of Neurology, Rouen University Hospital and University of Rouen, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bourilhon', 'Affiliation': 'Department of Neurophysiology, Rouen University Hospital and University of Rouen, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lefaucheur', 'Affiliation': 'Department of Neurology, Rouen University Hospital and University of Rouen, France.'}, {'ForeName': 'Teodor', 'Initials': 'T', 'LastName': 'Danaila', 'Affiliation': 'Department of Neurology C, Hopital Neurologique Pierre Wertheimer, Univ Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux, Lyon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Thobois', 'Affiliation': 'Department of Neurology C, Hopital Neurologique Pierre Wertheimer, Univ Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux, Lyon, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defebvre', 'Affiliation': 'Department of Neurology, Lille University Hospital, INSERM 1171, Lille, France.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Dujardin', 'Affiliation': 'Department of Neurology, Lille University Hospital, INSERM 1171, Lille, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Houeto', 'Affiliation': 'Departement of Neurology, CIC-INSERM 1402, CHU de Poitiers; Université de Poitiers, Poitiers France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Godefroy', 'Affiliation': 'Department of Neurology, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Krystkowiak', 'Affiliation': 'Department of Neurology, Amiens University Hospital, Amiens, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Martinaud', 'Affiliation': 'Department of Neurology, Caen University Hospital, Caen, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Gillibert', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Chastan', 'Affiliation': ""Department of Nuclear Medicine, Henri Becquerel Cancer Center and Rouen University Hospital, & QuantIF - LITIS [EA (Equipe d'Accueil) 4108 - FR CNRS 3638], Faculty of Medicine, University of Rouen, Rouen, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vera', 'Affiliation': ""Department of Nuclear Medicine, Henri Becquerel Cancer Center and Rouen University Hospital, & QuantIF - LITIS [EA (Equipe d'Accueil) 4108 - FR CNRS 3638], Faculty of Medicine, University of Rouen, Rouen, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Hannequin', 'Affiliation': 'Department of Neurology, Rouen University Hospital and University of Rouen, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Welter', 'Affiliation': 'Department of Neurophysiology, Rouen University Hospital and University of Rouen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Derrey', 'Affiliation': 'Department of Neurosurgery, Rouen University Hospital and University of Rouen, France.'}]",Neurology,['10.1212/WNL.0000000000011227']
2079,33199443,EGFR amplification and outcome in a randomised phase III trial of chemotherapy alone or chemotherapy plus panitumumab for advanced gastro-oesophageal cancers.,"OBJECTIVE


Epidermal growth factor receptor (EGFR) inhibition may be effective in biomarker-selected populations of advanced gastro-oesophageal adenocarcinoma (aGEA) patients. Here, we tested the association between outcome and  EGFR  copy number (CN) in pretreatment tissue and plasma cell-free DNA (cfDNA) of patients enrolled in a randomised first-line phase III clinical trial of chemotherapy or chemotherapy plus the anti-EGFR monoclonal antibody panitumumab in aGEA (NCT00824785).
DESIGN


EGFR  CN by either fluorescence in situ hybridisation (n=114) or digital-droplet PCR in tissues (n=250) and plasma cfDNAs (n=354) was available for 474 (86%) patients in the intention-to-treat (ITT) population. Tissue and plasma low-pass whole-genome sequencing was used to screen for coamplifications in receptor tyrosine kinases. Interaction between chemotherapy and EGFR inhibitors was modelled in patient-derived organoids (PDOs) from aGEA patients.
RESULTS


EGFR  amplification in cfDNA correlated with poor survival in the ITT population and similar trends were observed when the analysis was conducted in tissue and plasma by treatment arm. EGFR inhibition in combination with chemotherapy did not correlate with improved survival, even in patients with significant  EGFR  CN gains. Addition of anti-EGFR inhibitors to the chemotherapy agent epirubicin in PDOs, resulted in a paradoxical increase in viability and accelerated progression through the cell cycle, associated with p21 and cyclin B1 downregulation and cyclin E1 upregulation, selectively in organoids from  EGFR -amplified aGEA.
CONCLUSION


EGFR  CN can be accurately measured in tissue and liquid biopsies and may be used for the selection of aGEA patients. EGFR inhibitors may antagonise the antitumour effect of anthracyclines with important implications for the design of future combinatorial trials.",2020,"EGFR inhibition in combination with chemotherapy did not correlate with improved survival, even in patients with significant  EGFR  CN gains.","['advanced gastro-oesophageal cancers', 'advanced gastro-oesophageal adenocarcinoma (aGEA) patients', 'patients enrolled in a randomised first-line phase III clinical trial of', 'patient-derived organoids (PDOs) from aGEA patients']","['chemotherapy alone or chemotherapy plus panitumumab', 'chemotherapy or chemotherapy plus the anti-EGFR monoclonal antibody panitumumab']","['survival', 'EGFR inhibition']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0279628', 'cui_str': 'Adenocarcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0029250', 'cui_str': 'Organoids'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0508792,"EGFR inhibition in combination with chemotherapy did not correlate with improved survival, even in patients with significant  EGFR  CN gains.","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Smyth', 'Affiliation': 'Department of Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Vlachogiannis', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Somaieh', 'Initials': 'S', 'LastName': 'Hedayat', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Harbery', 'Affiliation': 'Cancer Therapeutics, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Hulkki-Wilson', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Salati', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Kouvelakis', 'Affiliation': 'Clinical Research & Development, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernandez-Mateos', 'Affiliation': 'Centre for Evolution and Cancer, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Cresswell', 'Affiliation': 'Centre for Evolution and Cancer, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Fontana', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Seidlitz', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Peckitt', 'Affiliation': 'Clinical Research & Development, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Hahne', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampis', 'Affiliation': 'Molecular Pathology, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Ruwaida', 'Initials': 'R', 'LastName': 'Begum', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Watkins', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Waddell', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Okines', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Department of Clinical Oncology, Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Was', 'Initials': 'W', 'LastName': 'Mansoor', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Cancer Clinical Trials Centre, Weston Park Cancer Centre, Sheffield, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fassan', 'Affiliation': 'Department of Medicine (DIMED), University of Padua, Padova, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': 'Histopathology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Braconi', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Vivanco', 'Affiliation': 'Cancer Therapeutics, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sottoriva', 'Affiliation': 'Centre for Evolution and Cancer, The Institute of Cancer Research, Sutton, UK.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Stange', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Valeri', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital NHS Trust, London, UK nicola.valeri@icr.ac.uk.'}]",Gut,['10.1136/gutjnl-2020-322658']
2080,33199470,Sustained Intensive Treatment and Long-term Effects on HbA 1c  Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI.,"OBJECTIVE


Continuous glucose monitoring (CGM) reduces HbA 1c  and time spent in hypoglycemia in people with type 1 diabetes (T1D) treated with multiple daily insulin injections (MDI) when evaluated over shorter time periods. It is unclear to what extent CGM improves and helps to maintain glucose control, treatment satisfaction, diabetes distress, hypoglycemic concerns, and overall well-being over longer periods of time.
RESEARCH DESIGN AND METHODS


The GOLD trial was a randomized crossover trial performed over 16 months of CGM treatment in people with T1D treated with MDI. People completing the trial ( n  = 141) were invited to participate in the current SILVER extension study in which 107 patients continued CGM treatment over 1 year along with the support of a diabetes nurse every 3 months.
RESULTS


The primary end point of the change in HbA 1c  over 1.0-1.5 years CGM use compared with previous self-monitoring of blood glucose during GOLD showed a decrease in HbA 1c  of 0.35% (95% CI 0.19-0.50%,  P  < 0.001). Time spent in hypoglycemia <3.0 mmol/L (54 mg/dL) and <4.0 mmol/L (72 mg/dL) decreased from 2.1 to 0.6% ( P  < 0.001) and from 5.4 to 2.9% ( P  < 0.001), respectively. Overall well-being (World Health Organization 5-item well-being index,  P  = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire,  P  < 0.001), and hypoglycemic confidence ( P  < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry,  P  = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale,  P  = 0.06). From randomization and screening in GOLD, HbA 1c  was lowered by 0.45% ( P  < 0.001) and 0.68% ( P  < 0.001) after 2.3 and 2.5 years, respectively.
CONCLUSIONS


The SILVER study supports beneficial long-term effects from CGM on HbA 1c , hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence in people with T1D managed with MDI.",2020,"Overall well-being (World Health Organization 5-item well-being index,  P  = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire,  P  < 0.001), and hypoglycemic confidence ( P  < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry,  P  = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale,  P  = 0.06).","['People With Type 1 Diabetes Treated With MDI', 'People completing the trial ( n  = 141) were invited to participate in the current SILVER extension study in which 107 patients continued', 'people with T1D managed with MDI', 'people with T1D treated with MDI', 'people with type 1 diabetes (T1D) treated with']","['Continuous glucose monitoring (CGM', 'multiple daily insulin injections (MDI', 'CGM', 'CGM treatment', 'HbA 1c  Reduction (SILVER Study) by CGM']","['HbA 1c , hypoglycemia, treatment satisfaction, well-being, and hypoglycemic confidence', 'Overall well-being (World Health Organization 5-item well-being index', 'blood glucose', 'change in HbA 1c', 'Time spent in hypoglycemia', 'treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire', 'hypoglycemic confidence', 'hypoglycemic fear (Hypoglycemia Fear Survey-Worry,  P  = 0.016) decreased and diabetes distress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",141.0,0.0305119,"Overall well-being (World Health Organization 5-item well-being index,  P  = 0.009), treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire,  P  < 0.001), and hypoglycemic confidence ( P  < 0.001) increased, while hypoglycemic fear (Hypoglycemia Fear Survey-Worry,  P  = 0.016) decreased and diabetes distress tended to decrease (Problem Areas in Diabetes Scale,  P  = 0.06).","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden marcus.lind@gu.se.'}, {'ForeName': 'Arndís F', 'Initials': 'AF', 'LastName': 'Ólafsdóttir', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bolinder', 'Affiliation': 'Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Dahlqvist', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Statistiska Konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'Jarl', 'Initials': 'J', 'LastName': 'Hellman', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Wijkman', 'Affiliation': 'Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Schwarcz', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Albrektsson', 'Affiliation': 'Statistiska Konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA.'}]",Diabetes care,['10.2337/dc20-1468']
2081,33199490,Randomized phase II and biomarker study of pembrolizumab plus bevacizumab versus pembrolizumab alone for recurrent glioblastoma patients.,"PURPOSE


Vascular endothelial growth factor (VEGF) is upregulated in glioblastoma and may contribute to immunosuppression. We performed a phase 2 study of pembrolizumab alone or with bevacizumab in recurrent glioblastoma.
EXPERIMENTAL DESIGN


Eighty bevacizumab-naive, recurrent glioblastoma patients randomized to pembrolizumab with bevacizumab (cohort A, n=50) or pembrolizumab monotherapy (cohort B, n=30). The primary endpoint was six-month progression-free survival (PFS-6). Assessed biomarkers included evaluation of tumor PD-L1 expression, TIL density, immune activation gene expression signature and plasma cytokines. The Neurologic Assessment in Neuro-Oncology (NANO) scale was used to prospectively assess neurologic function.
RESULTS


Pembrolizumab alone or with bevacizumab was well tolerated but of limited benefit. For cohort A, PFS-6 was 26.0% (95% CI: 16.3, 41.5), median OS was 8.8 months (95% CI: 7.7, 14.2), ORR was 20% and median duration of response was 48 weeks. For cohort B, PFS-6 was 6.7% (95% CI: 1.7, 25.4), median OS was 10.3 months (95% CI: 8.5, 12.5) and ORR was 0%. Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethasone use and increased post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels (cohort B). The NANO scale contributed to overall outcome assessment.
CONCLUSIONS


Pembrolizumab was ineffective as monotherapy and with bevacizumab for recurrent glioblastoma. The infrequent radiographic responses to combinatorial therapy were durable. Tumor immune biomarkers did not predict outcome. Baseline dexamethasone use and tumor MGMT warrant further study as potential biomarkers in GBM immunotherapy trials.",2020,"Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethasone use and increased post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels (cohort B).","['Eighty bevacizumab-naive, recurrent glioblastoma patients randomized to', 'recurrent glioblastoma patients']","['pembrolizumab', 'pembrolizumab alone or with bevacizumab', 'pembrolizumab plus bevacizumab', 'pembrolizumab with bevacizumab', 'bevacizumab', 'pembrolizumab monotherapy', 'Pembrolizumab']","['Tumor immune markers', 'ORR', 'six-month progression-free survival (PFS-6', 'evaluation of tumor PD-L1 expression, TIL density, immune activation gene expression signature and plasma cytokines', 'median OS', 'post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels', 'Neurologic Assessment in Neuro-Oncology (NANO) scale']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0069197', 'cui_str': 'Methylated-DNA-protein-cysteine methyltransferase'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.100615,"Tumor immune markers were not associated with OS, but worsened OS correlated with baseline dexamethasone use and increased post-therapy plasma VEGF (cohort A) and mutant IDH1, unmethylated MGMT and increased baseline PlGF and sVEGFR1 levels (cohort B).","[{'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Nayak', 'Affiliation': ""Neuro-Oncology, Center of Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center.""}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Molinaro', 'Affiliation': 'Department of Neurological Surgery, University of California, San Francisco.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Peters', 'Affiliation': 'The Preston Robert Tisch Brain Tumor Center at Duke, Duke Medical Center.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Clarke', 'Affiliation': 'Neurological Surgery, University of California, San Francisco.'}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Jordan', 'Affiliation': 'Department of Neuro-Oncology, Massachusetts General Hospital.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'de Groot', 'Affiliation': 'Neuro-Oncology, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Phioanh Leia', 'Initials': 'PL', 'LastName': 'Nghiemphu', 'Affiliation': 'Neurology, University of California Los Angeles.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kaley', 'Affiliation': 'Neurology, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Department of Neurosurgery, Huntsman Cancer Institute, University of Utah.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCluskey', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gaffey', 'Affiliation': 'Dana-Farber Cancer Institute.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': ""Department of Neurosurgery, Brigham and Women's Hospital.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cote', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital.""}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Severgnini', 'Affiliation': 'Center for Immuno-oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Yearley', 'Affiliation': 'Pharmacology, Merck & Co., Inc.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Merck&Co., Inc.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Blumenschein', 'Affiliation': 'GpGx, Merck Research Laboratories.'}, {'ForeName': 'Dan G', 'Initials': 'DG', 'LastName': 'Duda', 'Affiliation': 'Radiation Oncology, Steele Lab for Tumor Biology, Massachusetts General Hospital and Harvard Medical School.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Cancer Center, Massachusetts General Hospital.'}, {'ForeName': 'Rakesh K', 'Initials': 'RK', 'LastName': 'Jain', 'Affiliation': 'Edwin L. Steele Laboratories, Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center For Neuro-Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Center for Neuro-Oncology, Dana-Farber Cancer Institute David_Reardon@DFCI.harvard.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2500']
2082,33199550,A Follow-Up Study on the Effects of Football Scrimmages on Blink Reflex Parameters in Division I Athletes.,"OBJECTIVE


The objective was to conduct a follow-up study to access the effects of football scrimmages on blink reflex parameters using the Eyestat.
BACKGROUND


Eyestat is a noninvasive diagnostic tool measuring changes in blink reflex parameters. Prior research cited significant differences in various blink reflex parameters between active play, concussion, and baseline; however, the number of subjects for the active play population was small and within a football practice versus a football scrimmage.
DESIGN/METHODS


Fifty-eight division I male football players, between the ages of 18 and 22 years, participated in multiple sessions during a 3 week period of football scrimmages and a spring game. In addition, a subgroup of these subjects (N = 20) provided a minimal of 3 or more scans throughout the study. During various points of play, subjects completed the blink test and had heart rates assessed. For the blink test, subjects placed their face against the apparatus, which directed a puff of air to the corner of the subject's eye to stimulate the blink. Five puffs were administered in a random fashion over a 20-second period while videography captured and recorded the blink.
RESULTS


The results of the study cited significant differences in heart rates above 55% of predicted heart rate maximum in excursions only ( p  = 0.00), while significant differences were found in under the threshold ( p  = 0.05) and excursions ( p  = 0.00) in heart rates less than 55% of maximum heart rate. In those athletes (N = 20) where 3 scans were taken, there were no significant differences within subjects in any of the blink reflex parameters.
CONCLUSIONS


Future studies should continue to evaluate the timing of post exercise visual tracking assessments within healthy populations to determine the effects on ocular changes as eye-tracking devices are becoming increasingly popular to assess neurological health.",2020,"In those athletes (N = 20) where 3 scans were taken, there were no significant differences within subjects in any of the blink reflex parameters.
","['Division I Athletes', 'I male football players, between the ages of 18 and 22 years, participated in multiple sessions during a 3 week period of football scrimmages and a spring game', 'Fifty-eight division']",['Football Scrimmages'],"['Blink Reflex Parameters', 'blink reflex parameters', 'heart rates']","[{'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}]","[{'cui': 'C0596003', 'cui_str': 'Blink reflex'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",5.0,0.0196054,"In those athletes (N = 20) where 3 scans were taken, there were no significant differences within subjects in any of the blink reflex parameters.
","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Garner', 'Affiliation': ''}]",Neurology,['10.1212/01.wnl.0000719888.52369.bc']
2083,33199596,Thymus-derived B cell clones persist in the circulation after thymectomy in myasthenia gravis.,"Myasthenia gravis (MG) is a neuromuscular, autoimmune disease caused by autoantibodies that target postsynaptic proteins, primarily the acetylcholine receptor (AChR) and inhibit signaling at the neuromuscular junction. The majority of patients under 50 y with AChR autoantibody MG have thymic lymphofollicular hyperplasia. The MG thymus is a reservoir of plasma cells that secrete disease-causing AChR autoantibodies and although thymectomy improves clinical scores, many patients fail to achieve complete stable remission without additional immunosuppressive treatments. We speculate that thymus-associated B cells and plasma cells persist in the circulation after thymectomy and that their persistence could explain incomplete responses to resection. We studied patients enrolled in a randomized clinical trial and used complementary modalities of B cell repertoire sequencing to characterize the thymus B cell repertoire and identify B cell clones that resided in the thymus and circulation before and 12 mo after thymectomy. Thymus-associated B cell clones were detected in the circulation by both mRNA-based and genomic DNA-based sequencing. These antigen-experienced B cells persisted in the circulation after thymectomy. Many circulating thymus-associated B cell clones were inferred to have originated and initially matured in the thymus before emigration from the thymus to the circulation. The persistence of thymus-associated B cells correlated with less favorable changes in clinical symptom measures, steroid dose required to manage symptoms, and marginal changes in AChR autoantibody titer. This investigation indicates that the diminished clinical response to thymectomy is related to persistent circulating thymus-associated B cell clones.",2020,"The persistence of thymus-associated B cells correlated with less favorable changes in clinical symptom measures, steroid dose required to manage symptoms, and marginal changes in AChR autoantibody titer.",['myasthenia gravis'],[],['Thymus-associated B cell clones'],"[{'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]",[],"[{'cui': 'C0040112', 'cui_str': 'Thymus Extracts'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0009013', 'cui_str': 'Clone'}]",,0.0236695,"The persistence of thymus-associated B cells correlated with less favorable changes in clinical symptom measures, steroid dose required to manage symptoms, and marginal changes in AChR autoantibody titer.","[{'ForeName': 'Ruoyi', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Hoehn', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Casey S', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Minh C', 'Initials': 'MC', 'LastName': 'Pham', 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Homer', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Detterbeck', 'Affiliation': 'Department of Surgery, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama, Birmingham, AL 35294.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Jacobson', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, OX1 2JD Oxford, United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, OX1 2JD Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'Department of Neurology, The George Washington University, Washington, DC 20052.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Kleinstein', 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511; steven.kleinstein@yale.edu kevin.oconnor@yale.edu.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511; steven.kleinstein@yale.edu kevin.oconnor@yale.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2007206117']
2084,33199752,"Effect of desalted Salicornia europaea L. ethanol extract (PM-EE) on the subjects complaining memory dysfunction without dementia: a 12 week, randomized, double-blind, placebo-controlled clinical trial.","Desalted Salicornia europaea L. (SE) inhibits acetylcholine esterase, attenuates oxidative stress and inflammatory cytokines, and activates neurotrophic pathway. We performed 12-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy of PhytoMeal(a desalted SE)-ethanol extract (PM-EE), in improving the cognitive performance in patients with subjective memory impairment. 63 participants complaining memory dysfunction without dementia (Korean Mini-Mental State Examination [K-MMSE] score ≥ 23) were assigned to PM-EE 600 mg/day or placebo. The cognitive domain of the Alzheimer's disease assessment scale-Korean version (ADAS-K) was set as the primary outcome. After 12 weeks, there was no differences in the changes in the primary outcome or the frequency of adverse events between the groups. In the subgroup analysis for the 30 subjects with mild cognitive impairment (MCI, baseline K-MMSE scores ≤ 28), PM-EE significantly improved the color-reading score of the Korean color-word stroop test (8.2 ± 25.0 vs. - 4.7 ± 13.2, P = 0.018). Our findings suggest that PM-EE is safe but might not be effective in this setting of this study. However, PM-EE may improve the frontal executive function in the patients with MCI. Further large-sized studies with longer follow-up period is warranted (trial registration number KCT0003418).",2020,"After 12 weeks, there was no differences in the changes in the primary outcome or the frequency of adverse events between the groups.","['patients with subjective memory impairment', '63 participants complaining memory dysfunction without dementia (Korean Mini-Mental State Examination [K-MMSE] score\u2009≥\u200923', 'subjects complaining memory dysfunction without dementia']","['PM-EE 600\xa0mg/day or placebo', 'placebo', 'desalted Salicornia europaea L. ethanol extract (PM-EE', 'PhytoMeal(a desalted SE)-ethanol extract (PM-EE']","['color-reading score of the Korean color-word stroop test', 'mild cognitive impairment (MCI, baseline K-MMSE scores', 'frequency of adverse events', ""cognitive domain of the Alzheimer's disease assessment scale-Korean version (ADAS-K"", 'frontal executive function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0233794', 'cui_str': 'Memory impairment'}, {'cui': 'C3887551', 'cui_str': 'Memory dysfunction'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3256274', 'cui_str': 'Salicornia europaea extract'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",63.0,0.465385,"After 12 weeks, there was no differences in the changes in the primary outcome or the frequency of adverse events between the groups.","[{'ForeName': 'Woo-Jin', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Yong-Won', 'Initials': 'YW', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Da-Eun', 'Initials': 'DE', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea.'}, {'ForeName': 'Mee-Hyang', 'Initials': 'MH', 'LastName': 'Kweon', 'Affiliation': 'Research Center, Phyto Corporation, Seoul, 08826, Republic of Korea.'}, {'ForeName': 'Manho', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea. kimmanho@snu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-76938-x']
2085,33200214,ACTsmart: Guided Smartphone-Delivered Acceptance and Commitment Therapy for Chronic Pain-A Pilot Trial.,"BACKGROUND


Acceptance and commitment therapy (ACT) is a behavioral health intervention with strong empirical support for chronic pain but, to date, widespread dissemination is limited. Digital solutions improve access to care and can be integrated into patients' everyday lives.
OBJECTIVE


ACTsmart, a guided smartphone-delivered ACT intervention, was developed to improve the accessibility of an evidence-based behavioral treatment for chronic pain. In the present study, we evaluated the preliminary efficacy of ACTsmart in adults with chronic pain.
METHODS


The study was an open-label pilot trial. The treatment lasted for 8 weeks, and participants completed all outcome measures at pretreatment and posttreatment and at 3-, 6-, and 12-month follow-ups, with weekly assessments of selected measures during treatment. The primary outcome was pain interference. The secondary outcomes were psychological flexibility, values, insomnia, anxiety, depressive symptoms, health-related quality of life, and pain intensity. All outcomes were analyzed using linear mixed-effects models.
RESULTS


The sample consisted of 34 adults (88% women) with long-standing chronic pain (M=20.4 years, SD=11.7). Compliance to treatment was high, and at the end of treatment, we observed a significant improvement in the primary outcome of pain interference (d = -1.01). All secondary outcomes significantly improved from pretreatment to posttreatment with small to large effect sizes. Improvements were maintained throughout 12 months of follow-up.
CONCLUSION


The results of this pilot study provide preliminary support for ACTsmart as an accessible and effective behavioral health treatment for adults with chronic pain and warrant a randomized controlled trial to further evaluate the efficacy of the intervention.",2020,All secondary outcomes significantly improved from pretreatment to posttreatment with small to large effect sizes.,"['adults with chronic pain', '34 adults (88% women) with long-standing chronic pain (M=20.4\xa0years, SD=11.7']","['ACTsmart', 'commitment therapy (ACT', 'Guided Smartphone-Delivered Acceptance and Commitment Therapy']","['psychological flexibility, values, insomnia, anxiety, depressive symptoms, health-related quality of life, and pain intensity', 'pain interference']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",88.0,0.179796,All secondary outcomes significantly improved from pretreatment to posttreatment with small to large effect sizes.,"[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gentili', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vendela', 'Initials': 'V', 'LastName': 'Zetterqvist', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Rickardsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Holmström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Simons', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Rikard K', 'Initials': 'RK', 'LastName': 'Wicksell', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa360']
2086,33200217,"Sirolimus for patients with connective tissue disease-related refractory thrombocytopenia: a single-arm, open-label clinical trial.","OBJECTIVES


Connective tissue disease-related thrombocytopenia (CTD-TP) is a problematic disorder in clinical practice. Because the first-line therapy of glucocorticoid and/or immunosuppressants is not effective for refractory cases, alternative treatment approaches are urgently needed. The present study investigated the efficacy and safety of sirolimus in refractory CTD-TP patients.
METHODS


This single-centre, single-arm, phase II study enrolled 20 refractory CTD-TP patients between September 2017 and September 2018 (registered on ClinicalTrials.gov: NCT03688191). Oral sirolimus administration was dose-adjusted to maintain a therapeutic range of 6-15 ng/ml for 6 months. The primary endpoints were partial and complete remission rates at 6 months.
RESULTS


Twelve (60%) patients achieved the primary end point with a 50% complete remission rate after 6 months. Among the 14 SLE patients, the overall response rate was 71.4%, with a complete remission rate of 64.3%. None of the primary Sjögren's syndrome cases responded to sirolimus. There was no significant difference in baseline clinical characteristics or lymphocyte subpopulations between responders and non-responders. No severe side effect was detected during the study.
CONCLUSION


Sirolimus is an effective and safe treatment option for refractory CTD-TP patients.
TRIAL REGISTRATION


https://clinicaltrials.gov, NCT03688191.",2020,"Among the 14 SLE patients, the overall response rate was 71.4%, with a complete remission rate of 64.3%.","['refractory CTD-TP patients', 'patients with connective tissue disease-related refractory thrombocytopenia']","['sirolimus', 'Oral sirolimus', 'Sirolimus']","['partial and complete remission rates', 'complete remission rate', 'severe side effect', 'efficacy and safety', 'overall response rate', 'baseline clinical characteristics or lymphocyte subpopulations']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009782', 'cui_str': 'Disorder of connective tissue'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2826321', 'cui_str': 'Refractory thrombocytopenia'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}]",20.0,0.0661919,"Among the 14 SLE patients, the overall response rate was 71.4%, with a complete remission rate of 64.3%.","[{'ForeName': 'Chanyuan', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Disease (NCRC-DID), Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Disease (NCRC-DID), Beijing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Disease (NCRC-DID), Beijing, China.'}, {'ForeName': 'Mengtao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Disease (NCRC-DID), Beijing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Rheumatology, Peking Union Medical College Hospital, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Peking Union Medical College and Chinese Academy of Medical Sciences, National Clinical Research Center for Dermatologic and Immunologic Disease (NCRC-DID), Beijing, China.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa645']
2087,33200220,Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study.,"OBJECTIVE


To evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active RA who were either naïve to DMARDs or who had inadequate response (IR) to MTX.
METHODS


Analyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naïve patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4 mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4 mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4 mg (+MTX) at week 24. Low disease activity (LDA) [Simple Disease Activity Index (SDAI) ≤11], clinical remission (SDAI ≤ 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5] were assessed. Data were assessed using a non-responder imputation.
RESULTS


At week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib. Over 148 weeks, 3.6% and 10.7% of MTX-IR patients discontinued across treatment groups due to lack of efficacy or due to adverse events, respectively; discontinuation rates were similar in the DMARD-naïve population.
CONCLUSION


Treatment with baricitinib 4 mg demonstrated efficacy for up to 3 years and was well tolerated.",2020,"At week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib.","['patients with active RA who were either naïve to DMARDs or who had inadequate response (IR) to MTX', 'patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment']","['MTX monotherapy', 'MTX', 'open-label baricitinib 4\u2009mg monotherapy; MTX-IR patients treated with adalimumab (+MTX', 'baricitinib', 'open-label baricitinib 4\u2009mg (+MTX', 'placebo (+MTX', 'baricitinib 4\u2009mg (+MTX']","['SDAI remission', 'tolerated', 'Low disease activity (LDA', 'SDAI LDA', 'Simple\xa0Disease Activity\xa0Index (SDAI) ≤11], clinical remission (SDAI ≤ 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI', 'discontinuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.0180227,"At week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bochao', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Taylor', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Charité - University of Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Elias', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Cardoso', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ortmann', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Walls', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Cochin Hospital, Paris, France.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa576']
2088,33200227,A randomized phase III trial of personalized peptide vaccination for castration‑resistant prostate cancer progressing after docetaxel.,"First‑line chemotherapy for men with metastatic castration‑resistant prostate cancer (mCRPC) has been employed to improve overall survival (OS) and progression‑free survival (PFS). However, several new agents for CRPC after first‑line chemotherapy prolonged survival by only a few months. To develop a new treatment modality, we conducted a phase III randomized trial of personalized peptide vaccination (PPV) for human leukocyte antigen (HLA)‑A24‑positive patients with castration‑resistant prostate cancer (CRPC) for whom docetaxel chemotherapy failed. This randomized, double‑blind, placebo‑controlled, phase III trial was carried out at 68 medical centers in Japan. Patients were randomly assigned at a 2:1 ratio to receive PPV or placebo. Four of 12 warehouse peptides selected based on pre‑existing peptide‑specific immunoglobulin G levels or the corresponding placebo were subcutaneously injected in 6 doses weekly and then bi‑weekly following the maximum of 30 doses until disease progression. The primary end‑point was overall survival (OS). Efficacy analyses were performed by the full analysis set. Between August 2013 and April 2016, 310 patients were randomly assigned, and 306 patients were analyzed. Baseline characteristics were balanced between groups. The estimated median OS was 16.1 months [95% confidence interval (CI), 13‑18.2] with PPV and 16.9 months (95% CI, 13.1‑20.4) with placebo [hazard ratio (HR), 1.04, 95% CI, 0.80‑1.37; P=0.77]. Grade ≥3 adverse events were observed in 41% of both groups. The analysis of treatment arm effects among subgroups revealed lower HRs for OS in favor of the PPV arm in patients with <64% neutrophils (HR, 0.55, 95% CI, 0.33‑0.93; P=0.03) or ≥26% lymphocytes (HR, 0.70, 95% CI, 0.52‑0.92; P=0.02) at baseline. PPV did not prolong OS in HLA‑A24‑positive patients with CRPC progressing after docetaxel chemotherapy. Subgroup analysis suggested that the patients with a lower proportion of neutrophils or a higher proportion of lymphocytes at baseline can receive survival benefits from PPV treatment.",2020,Grade ≥3 adverse events were observed in 41% of both groups.,"['Between August\xa02013 and April\xa02016, 310\xa0patients were randomly assigned, and 306\xa0patients were analyzed', 'HLA)‑A24‑positive patients with castration‑resistant prostate cancer\xa0(CRPC) for whom docetaxel chemotherapy failed', 'men with metastatic castration‑resistant prostate cancer\xa0(mCRPC', '68\xa0medical centers in Japan', 'human leukocyte antigen\xa0', 'HLA‑A24‑positive patients with CRPC progressing after docetaxel chemotherapy', 'castration‑resistant prostate cancer progressing after docetaxel']","['PPV', 'personalized peptide vaccination', 'placebo‑controlled', 'PPV or placebo', 'placebo', 'personalized peptide vaccination\xa0(PPV', 'First‑line chemotherapy']","['estimated median OS', 'Grade\xa0≥3 adverse events', 'survival benefits', 'overall survival\xa0(OS', 'overall survival\xa0(OS) and progression‑free survival\xa0(PFS', 'survival']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.503744,Grade ≥3 adverse events were observed in 41% of both groups.,"[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Noguchi', 'Affiliation': 'Cancer Vaccine Center and Department of Urology, Kurume University, Kurume, Fukuoka 839‑0863, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, Nara Medical University Hospital, Kashihara, Nara 634‑8522, Japan.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Arai', 'Affiliation': 'Department of Urology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Saitama 343‑8555, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Yokohama City University Medical Center, Yokohama, Kanagawa 232‑0024, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'Department of Urology, Shikoku Cancer Center, Matsuyama, Ehime 791‑0280, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Urology, Yamaguchi University Hospital, Ube, Yamaguchi 755‑8505, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fukasawa', 'Affiliation': 'Department of Urology, Chiba Cancer Center, Chiba, Chiba 260‑8717, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Kohjimoto', 'Affiliation': 'Department of Urology, Wakayama Medical University Hospital, Wakayama, Wakayama 641‑8510, Japan.'}, {'ForeName': 'Hideomi', 'Initials': 'H', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Urology, Asahi General Hospital, Asahi, Chiba 289‑2511, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takenaka', 'Affiliation': 'Department of Urology, Tottori University Hospital, Yonago, Tottori 683‑8504, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Urology, Kobe University Hospital, Kobe, Hyogo 650‑0017, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology, Kindai University Hospital, Sayama, Osaka 589‑8511, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Sanshinkai Hara Hospital, Fukuoka, Fukuoka 812‑0033, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Egawa', 'Affiliation': 'Department of Urology, The Jikei University Hospital, Minatoku, Tokyo 105‑8471, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, Chyuoku, Tokyo 104‑0045, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Hinotsu', 'Affiliation': 'Department of Urology, Sapporo Medical University, Sapporo, Hokkaido 060‑8543, Japan.'}, {'ForeName': 'Kyogo', 'Initials': 'K', 'LastName': 'Itoh', 'Affiliation': 'Cancer Vaccine Center and Department of Urology, Kurume University, Kurume, Fukuoka 839‑0863, Japan.'}]",Oncology reports,['10.3892/or.2020.7847']
2089,33200309,LSG vs MGB-OAGB: 5-Year Follow-up Data and Comparative Outcome of the Two Procedures over Long Term-Results of a Randomised Control Trial.,"BACKGROUND


Bariatric surgery is a durable and effective way for the management of obesity and resolution of related comorbidities. The aim of this study is to evaluate the outcome of laparoscopic sleeve gastrectomy (LSG) and one-anastomosis gastric bypass (OAGB) over long term in a South Asian population.
MATERIALS AND METHODS


This is a prospective randomised trial comparing the outcome of 100 and 101 LSG and OAGB patients respectively after 5-year follow-up. This study is in continuity with previous published papers with 1- and 3-year follow-up. 71 LSG and 73 OAGB patients followed at 5 years. The results of these patients were analysed and compared in terms of %EWL, comorbidity resolution and quality of life (QoL) at 5 years. Bariatric analysis reporting and outcome system (BAROS) was used to assess the outcome of patients.
RESULTS


At 5-year follow-up, both LSG and OAGB patients performed well and patients had significant improvement in BMI (kg/m 2) . The mean preoperative BMI of LSG and OAGB patients was 44.89 ± 7.94 and 45.32 ± 8.24, and their mean BMI at 5 years was 33.41 ± 6.02, 30.80 ± 3.40 respectively. At 5 years, %EWL was 55.95 ± 27.01 and 65.28 ± 13.98 for LSG and OAGB patients respectively. The QoL score of LSG and OAGB patients was 1.86 ± 0.56 and 2.35 ± 0.41 while comorbidity score was 1.84 ± 0.68 and 2.24 ± 0.62 respectively at 5 years.
CONCLUSIONS


Both LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.",2020,"Both LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.","['a South Asian population', '100 and 101 LSG and OAGB patients respectively after 5-year follow-up']",['laparoscopic sleeve gastrectomy (LSG) and one-anastomosis gastric bypass (OAGB'],"['BMI', 'weight loss, comorbidity resolution and improvement in QoL. OAGB', 'QoL score', 'mean preoperative BMI', 'comorbidity resolution and quality of life (QoL', 'Bariatric analysis reporting and outcome system (BAROS']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.0360337,"Both LSG and OAGB are effective bariatric procedures over long term with respect to weight loss, comorbidity resolution and improvement in QoL. OAGB is significantly better than LSG in all the three parameters at 5 years.","[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery, Synergy Plus Hospital, NH2, Near Guru Ka Taal, Agra, Uttar Pradesh, 282007, India.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Tantia', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India. omtantia@gmail.com.'}, {'ForeName': 'Ghanshyam', 'Initials': 'G', 'LastName': 'Goyal', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Tamonas', 'Initials': 'T', 'LastName': 'Chaudhuri', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Anshuman', 'Initials': 'A', 'LastName': 'Poddar', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Kajari', 'Initials': 'K', 'LastName': 'Majumdar', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}, {'ForeName': 'Sonam', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Minimal Access & Bariatric Surgery ILS Hospitals, DD-6, Sector 1, Salt Lake City, Kolkata, West Bengal, 700064, India.'}]",Obesity surgery,['10.1007/s11695-020-05119-6']
2090,33200382,Promoting Strength Training Among Baby Boomers: Message Framing Effects on Motivation and Behavior.,"BACKGROUND


Regular participation in strength training significantly enhances older adults' physical and functional health, yet only 14% of adults over age 50 report engaging in strength training at least twice per week. Exercise messages about why and how older adults should engage in strength training could influence their perceptions of and participation in the behavior. This study was designed to promote strength training among adults aged 50-70 and to determine whether the message frame accompanying a brief workout would have an impact on participants' motivation, self-efficacy, and/or physical activity behavior.
METHODS


Participants (N = 308) were randomly assigned to one of four message conditions: Easy Intrinsic, Hard Intrinsic, Easy Extrinsic, or Hard Extrinsic. Immediately after completing baseline measures of motivation and physical activity, participants received the recommended strength training workout and corresponding motivational message. They completed follow-up measures of motivation and physical activity 2 weeks later.
RESULTS


Controlled regulation was higher at follow-up among participants exposed to an extrinsic message relative to an intrinsic message (F(3,208) = 3.08, p = .03). Strength training (Z = - 5.95, p < .001) and moderate physical activity (Z = - 3.23, p = .001) increased among participants not engaging in regular strength training at baseline.
CONCLUSIONS


These results suggest message framing may have a short-term impact on Baby Boomers' physical activity motivation, such that emphasizing extrinsic goals (i.e., weight loss and appearance) may contribute to controlled motivation. However, repeated measurements are needed to determine the longer-term maintenance and influence of these effects.",2020,"RESULTS


Controlled regulation was higher at follow-up among participants exposed to an extrinsic message relative to an intrinsic message (F(3,208) = 3.08, p = .03).","['adults aged 50-70', 'Baby Boomers', 'Participants (N\xa0=\xa0308']","['strength training workout and corresponding motivational message', 'strength training']","['Strength training', 'moderate physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",308.0,0.0190702,"RESULTS


Controlled regulation was higher at follow-up among participants exposed to an extrinsic message relative to an intrinsic message (F(3,208) = 3.08, p = .03).","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Mailey', 'Affiliation': 'Department of Kinesiology, Kansas State University, KS, Manhattan, USA. emailey@ksu.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gasper', 'Affiliation': 'Department of Kinesiology, Kansas State University, KS, Manhattan, USA.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Dlugonski', 'Affiliation': 'Department of Athletic Training and Clinical Nutrition, University of Kentucky, KY, Lexington, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Besenyi', 'Affiliation': 'Department of Kinesiology, Kansas State University, KS, Manhattan, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09939-9']
2091,33200390,The effects of tropicamide and cyclopentolate hydrochloride on laser flare meter measurements in uveitis patients: a comparative study.,"PURPOSE


To investigate the effects of 1% cyclopentolate hydrochloride and 1% tropicamide eye drops on aqueous flare measurements by using the laser flare meter.
METHODS


One hundred forty eight eyes of 83 patients with inactive uveitis were enrolled. The patients were randomly assigned to receive either 1% tropicamide (Group 1) or 1% cyclopentolate hydrochloride (Group 2) as the mydriatic agent. Best corrected visual acuity (BCVA), intraocular pressure (IOP), aqueous flare reaction levels measured by laser flare meter device (FM 600, Kowa, Kowa Company Ltd, Nagoya, Japan) before and post dilatation agents were evaluated.
RESULTS


Group 1 consisted of 75 eyes and Group 2 consisted of 77 eyes. The mean age of Group 1 patients was 34.85 ± 12.60 (range, 12-64) years; the mean age of Group 2 was 36.92 ± 13.30 (range, 12-70) years (p > 0.05). The mean BCVAs of two groups were 0.16 ± 0.43 (range, 0.00-3.10) logMAR and 0.17 ± 0.42 (range, 0.00-3.10) logMAR, respectively. There were no statistically significant differences between Groups 1 and 2 regarding gender or clinical characteristics (p > 0.05). No significant differences were detected in pre- or post-dilatation values between two groups (p = 0.470, p = 0.998).
CONCLUSIONS


As a result, anterior chamber flare values in uveitis patients do not differ significantly between 1% tropicamide and 1% cyclopentolate hydrochloride, and both agents can be safely used for dilatation during examination of patients with uveitis.",2020,There were no statistically significant differences between Groups 1 and 2 regarding gender or clinical characteristics (p > 0.05).,"['uveitis patients', 'One hundred forty eight eyes of 83 patients with inactive uveitis were enrolled']","['tropicamide and cyclopentolate hydrochloride', 'cyclopentolate hydrochloride', 'mydriatic agent', 'tropicamide', 'cyclopentolate hydrochloride and 1% tropicamide eye drops']","['anterior chamber flare values', 'pre- or post-dilatation values', 'Best corrected visual acuity (BCVA), intraocular pressure (IOP), aqueous flare reaction levels measured by laser flare meter device (FM 600, Kowa, Kowa Company Ltd, Nagoya, Japan', 'mean BCVAs', 'laser flare meter measurements']","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0357664', 'cui_str': 'Cyclopentolate hydrochloride'}, {'cui': 'C0026964', 'cui_str': 'Mydriatic agent'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}]","[{'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",83.0,0.0214928,There were no statistically significant differences between Groups 1 and 2 regarding gender or clinical characteristics (p > 0.05).,"[{'ForeName': 'Medine', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Manisa Merkezefendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Guven Yilmaz', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey. drsuzan2003@yahoo.com.'}, {'ForeName': 'Melis', 'Initials': 'M', 'LastName': 'Palamar', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Ates', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Yagci', 'Affiliation': 'Department of Ophthalmology, Ege University School of Medicine, 35100, Bornova, Izmir, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01639-3']
2092,33200394,Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study.,"INTRODUCTION


In the SPIRIT-H2H (ClinicalTrials.gov: NCT03151551) trial in biologic-naïve patients with active psoriatic arthritis (PsA), ixekizumab (IXE) was superior to adalimumab (ADA) at week 24 in terms of achieving a combined endpoint of ≥ 50% improved response in the American College of Rheumatology scale score (ACR50) and 100% improvement in the Psoriasis Areas and Severity Index (PASI100), and was non-inferior in terms of achieving ACR50. IXE resulted in similar improvements of PsA manifestations irrespective of the use of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), while ADA response was higher with concomitant csDMARD use. The aim of this study was to determine the efficacy and safety of treatment with IXE and ADA with or without methotrexate (MTX), the most commonly use csDMARD, through week 52 in patients with PsA.
METHODS


In the open-label, rater-blinded, head-to-head SPIRIT-H2H trial, randomization of patients was stratified by concomitant use of csDMARD and moderate-to-severe plaque psoriasis involvement. In the post-hoc subgroup analysis presented here, subgroups were defined as with/without concomitant MTX use at baseline. Treatment group effects within subgroups were tested using Fisher's exact test. Missing data were imputed using non-responder imputation.
RESULTS


By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use. When used without concomitant MTX, IXE resulted in significantly higher response versus ADA in terms of the combined ACR50 and PASI100 (p = 0.002) endpoint, minimal disease activity (p = 0.016), and very low disease activity (p = 0.037). The safety of both agents was consistent with their known safety profiles regardless of concomitant MTX use.
CONCLUSION


In PsA patients with inadequate control of the disease, IXE delivers consistent efficacy in several clinical domains of the disease regardless of concomitant MTX use. The efficacy of ADA is increased by the concomitant use of MTX. These findings can inform treatment decisions when considering the need for concomitant MTX use with IXE or ADA at initiation or for long-term maintenance.",2020,"By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use.","['Biologic-Naïve Patients with Psoriatic Arthritis', 'biologic-naïve patients with active psoriatic arthritis (PsA', 'patients with PsA.\nMETHODS\n\n\nIn the open-label, rater-blinded, head-to-head SPIRIT-H2H trial, randomization of patients was stratified by concomitant use of csDMARD and moderate-to-severe plaque psoriasis involvement']","['IXE', 'MTX, IXE', 'IXE and ADA with or without methotrexate (MTX', 'Ixekizumab with or Without Methotrexate']","['ADA response', 'efficacy and safety', 'efficacy of ADA', 'Efficacy and Safety', 'low disease activity', 'ADA efficacy', 'Rheumatology scale score (ACR50', 'minimal disease activity']","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",,0.0507742,"By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sebba', 'Affiliation': 'Arthritis Associates, Palm Harbor, FL, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Ruderman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians University of Munich, Munich, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sapin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Gellett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey Trevelin', 'Initials': 'AT', 'LastName': 'Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lingnan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Soyi', 'Initials': 'S', 'LastName': 'Liu-Leage', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Reis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'School of Medicine, Griffith University, Brisbane, QLD, Australia. drpnash@tpg.com.au.'}]",Rheumatology and therapy,['10.1007/s40744-020-00250-3']
2093,33197395,"Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial.","BACKGROUND


Intravenous ferric carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of ferric carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure.
METHODS


AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100-299 μg/L with transferrin saturation <20%), and had a left ventricular ejection fraction of less than 50%. Before hospital discharge, participants were randomly assigned (1:1) to receive intravenous ferric carboxymaltose or placebo for up to 24 weeks, dosed according to the extent of iron deficiency. To maintain masking of patients and study personnel, treatments were administered in black syringes by personnel not involved in any study assessments. The primary outcome was a composite of total hospitalisations for heart failure and cardiovascular death up to 52 weeks after randomisation, analysed in all patients who received at least one dose of study treatment and had at least one post-randomisation data point. Secondary outcomes were the composite of total cardiovascular hospitalisations and cardiovascular death; cardiovascular death; total heart failure hospitalisations; time to first heart failure hospitalisation or cardiovascular death; and days lost due to heart failure hospitalisations or cardiovascular death, all evaluated up to 52 weeks after randomisation. Safety was assessed in all patients for whom study treatment was started. A pre-COVID-19 sensitivity analysis on the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT02937454, and has now been completed.
FINDINGS


Between March 21, 2017, and July 30, 2019, 1525 patients were screened, of whom 1132 patients were randomly assigned to study groups. Study treatment was started in 1110 patients, and 1108 (558 in the carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value. 293 primary events (57·2 per 100 patient-years) occurred in the ferric carboxymaltose group and 372 (72·5 per 100 patient-years) occurred in the placebo group (rate ratio [RR] 0·79, 95% CI 0·62-1·01, p=0·059). 370 total cardiovascular hospitalisations and cardiovascular deaths occurred in the ferric carboxymaltose group and 451 occurred in the placebo group (RR 0·80, 95% CI 0·64-1·00, p=0·050). There was no difference in cardiovascular death between the two groups (77 [14%] of 558 in the ferric carboxymaltose group vs 78 [14%] in the placebo group; hazard ratio [HR] 0·96, 95% CI 0·70-1·32, p=0·81). 217 total heart failure hospitalisations occurred in the ferric carboxymaltose group and 294 occurred in the placebo group (RR 0·74; 95% CI 0·58-0·94, p=0·013). The composite of first heart failure hospitalisation or cardiovascular death occurred in 181 (32%) patients in the ferric carboxymaltose group and 209 (38%) in the placebo group (HR 0·80, 95% CI 0·66-0·98, p=0·030). Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to ferric carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47-0·97, p=0·035). Serious adverse events occurred in 250 (45%) of 559 patients in the ferric carboxymaltose group and 282 (51%) of 551 patients in the placebo group.
INTERPRETATION


In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with ferric carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effect on the risk of cardiovascular death.
FUNDING


Vifor Pharma.",2020,"Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to ferric carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47-0·97, p=0·035).","['Between March 21, 2017, and July 30, 2019', '121 sites in Europe, South America, and Singapore', 'iron deficiency at discharge after acute heart failure', 'patients who were stabilised after an episode of acute heart failure', 'Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100-299 μg/L with transferrin saturation <20%), and had a left ventricular ejection fraction of less than 50', '1525 patients were screened, of whom 1132 patients', 'patients with chronic heart failure and iron deficiency', 'patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with', '1110 patients, and 1108 (558 in the carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value']","['intravenous ferric carboxymaltose or placebo', 'placebo', 'Ferric carboxymaltose', 'ferric carboxymaltose']","['Safety', 'composite of first heart failure hospitalisation or cardiovascular death', '370 total cardiovascular hospitalisations and cardiovascular deaths', 'cardiovascular death', 'risk of cardiovascular death', 'risk of heart failure hospitalisations', 'Serious adverse events', '217 total heart failure hospitalisations', 'symptoms and quality of life', 'composite of total hospitalisations for heart failure and cardiovascular death', 'composite of total cardiovascular hospitalisations and cardiovascular death; cardiovascular death; total heart failure hospitalisations; time to first heart failure hospitalisation or cardiovascular death; and days lost due to heart failure hospitalisations or cardiovascular death', 'heart failure hospitalisations and cardiovascular death']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",1525.0,0.702036,"Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to ferric carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47-0·97, p=0·035).","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Wroclaw, Poland; Center for Heart Diseases, University Hospital in Wrocław, Wroclaw, Poland. Electronic address: piotr.ponikowski@umed.wroc.pl.'}, {'ForeName': 'Bridget-Anne', 'Initials': 'BA', 'LastName': 'Kirwan', 'Affiliation': 'Department of Clinical Research, SOCAR Research, Nyon, Switzerland; London School of Hygiene & Tropical Medicine, University College London, London, UK.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Charité, Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'McDonagh', 'Affiliation': ""King's College Hospital, London, UK; School of Cardiovascular Medicine & Sciences, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dorobantu', 'Affiliation': 'Cardiology Department, Emergency Hospital of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Klinika Kardiologii, Uniwersytet Medyczny w Łodzi, Lodz, Poland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fabien', 'Affiliation': 'Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Heart Failure Unit, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Udo Michael', 'Initials': 'UM', 'LastName': 'Göhring', 'Affiliation': 'Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Keren', 'Affiliation': 'Hadassah Medical Center, Department of Cardiology, Jerusalem, Israel.'}, {'ForeName': 'Irakli', 'Initials': 'I', 'LastName': 'Khintibidze', 'Affiliation': 'Aleksandre Aladashvili Clinic, Tbilisi, Georgia.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Kragten', 'Affiliation': 'Maastricht University Medical Center, Heerlen, Netherlands.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, International Society of Cardiovascular Pharmacotherapy, Córdoba, Argentina.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Department of Cardiology, University and Civil Hospital, Brescia, Italy.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Milicic', 'Affiliation': 'University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ohlsson', 'Affiliation': 'Department of Internal Medicine, Malmö University Hospital, Malmö, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'M D Strazhesko Institute of Cardiology, Kyiv, Ukraine.'}, {'ForeName': 'Domingo A', 'Initials': 'DA', 'LastName': 'Pascual-Figal', 'Affiliation': 'Cardiology Department, Hospital Virgen de la Arrixaca, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'UniversitätsSpietal Zürich, Klinik für Kardiologie, Zürich, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Center, Clinical Translational and Research Office, Singapore.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Skouri', 'Affiliation': 'American University of Beirut, Medical Center Beirut, Beirut, Lebanon.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'University Medical Center Groningen, Department of Cardiology, Groningen, Netherlands.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center, Clinical Cardiovascular Research Institute, Haifa, Israel.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comin-Colet', 'Affiliation': 'Hospital Universitari Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cohen-Solal', 'Affiliation': 'Hospital Lariboisière, INSERM, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Danchin', 'Affiliation': 'European Hospital Georges Pompidou, Paris, France.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Doehner', 'Affiliation': 'Charité, Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Dargie', 'Affiliation': 'Robertson Center for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Motro', 'Affiliation': 'Sheba Medical Center, Tel Aviv University, Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'University Medical Center Göttingen, Göttingen, Germany; DZHK (German Center for Cardiovascular Research), Göttingen partner site, Göttingen, Germany.'}, {'ForeName': 'Klaus H', 'Initials': 'KH', 'LastName': 'Jensen', 'Affiliation': 'Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Clinical Research, SOCAR Research, Nyon, Switzerland.'}, {'ForeName': 'Ewa A', 'Initials': 'EA', 'LastName': 'Jankowska', 'Affiliation': 'Department of Heart Diseases, Wrocław Medical University, Wroclaw, Poland; Center for Heart Diseases, University Hospital in Wrocław, Wroclaw, Poland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32339-4']
2094,33197403,Sigh in patients with acute hypoxemic respiratory failure and acute respiratory distress syndrome: the PROTECTION pilot randomized clinical trial.,"BACKGROUND


Sigh is a cyclic brief recruitment manoeuvre: previous physiological studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity and increase release of surfactant.
RESEARCH QUESTION


Is the clinical application of sigh during pressure support ventilation (PSV) feasible?
STUDY DESIGN AND METHODS


We conducted a multi-center non-inferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or acute respiratory distress syndrome undergoing PSV. Patients were randomized to the No Sigh group and treated by PSV alone, or to the Sigh group, treated by PSV plus sigh (increase of airway pressure to 30 cmH 2 Ofor 3 seconds once per minute) until day 28 or death or successful spontaneous breathing trial. The primary endpoint of the study was feasibility, assessed as non-inferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiological parameters in the first week from randomization, 28-day mortality and ventilator-free days.
RESULTS


Two-hundred fifty-eight patients (31% women; median age 65 [54-75] years) were enrolled. In the Sigh group, 23% of patients failed to remain on assisted ventilation vs. 30% in the No Sigh group (absolute difference -7%, 95%CI -18% to 4%; p=0.015 for non-inferiority). Adverse events occurred in 12% vs. 13% in Sigh vs. No Sigh (p=0.852). Oxygenation was improved while tidal volume, respiratory rate and corrected minute ventilation were lower over the first 7 days from randomization in Sigh vs. No Sigh. There was no significant difference in terms of mortality (16% vs. 21%, p=0.342) and ventilator-free days (22 [7-26] vs. 22 [3-25] days, p=0.300) for Sigh vs. No Sigh.
INTERPRETATION


Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.",2020,"There was no significant difference in terms of mortality (16% vs. 21%, p=0.342) and ventilator-free days (22 [7-26] vs. 22 [3-25] days, p=0.300) for Sigh vs. No Sigh.
INTERPRETATION


Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.","['Two-hundred fifty-eight patients (31% women; median age 65 [54-75] years) were enrolled', 'patients with acute hypoxemic respiratory failure and acute respiratory distress syndrome', 'adult intubated patients with acute hypoxemic respiratory failure or acute respiratory distress syndrome undergoing PSV']","['PSV alone, or to the Sigh group, treated by PSV plus sigh (increase of airway pressure to 30 cmH 2']","['tidal volume, respiratory rate and corrected minute ventilation', 'Adverse events', 'mortality', 'safety, physiological parameters in the first week from randomization, 28-day mortality and ventilator-free days']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0425481', 'cui_str': 'Sighing respiration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",258.0,0.220752,"There was no significant difference in terms of mortality (16% vs. 21%, p=0.342) and ventilator-free days (22 [7-26] vs. 22 [3-25] days, p=0.300) for Sigh vs. No Sigh.
INTERPRETATION


Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Pathophysiology and Transplantation, University of Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Ca' Granda Maggiore PoliclinicoHospital, Milan, Italy. Electronic address: tommaso.mauri@unimi.it.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Foti', 'Affiliation': 'Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy; University of Milan-Bicocca, School of Medicine and Surgery, Monza, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Fornari', 'Affiliation': 'University of Milan-Bicocca, School of Medicine and Surgery, Monza, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Pathophysiology and Transplantation, University of Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Ca' Granda Maggiore PoliclinicoHospital, Milan, Italy.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pinciroli', 'Affiliation': 'University of Milan-Bicocca, School of Medicine and Surgery, Monza, Italy; Anesthesia and Critical Care Service 1, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Lovisari', 'Affiliation': 'Anesthesia and Critical Care Service 1, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Ca' Granda Maggiore PoliclinicoHospital, Milan, Italy.""}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Volta', 'Affiliation': 'Morphology, surgery and experimental medicine, Anesthesia and Intensive Care Unit, University of Ferrara, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': 'Morphology, surgery and experimental medicine, Anesthesia and Intensive Care Unit, University of Ferrara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rona', 'Affiliation': 'Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy.'}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Rondelli', 'Affiliation': 'Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Department of Medicine - DIMED, University of Padua, Italy; Institute of Anesthesia and Intensive Care, Padua Hospital, Padua, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Anesthesia and Intensive Care, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Rihard', 'Initials': 'R', 'LastName': 'Knafelj', 'Affiliation': 'University Medical Center Ljubljana, Center for Internal Intensive medicine (MICU), Ljubljana, Slovenia.'}, {'ForeName': 'Vojka', 'Initials': 'V', 'LastName': 'Gorjup', 'Affiliation': 'University Medical Center Ljubljana, Center for Internal Intensive medicine (MICU), Ljubljana, Slovenia.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Colombo', 'Affiliation': 'Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cortegiani', 'Affiliation': 'Department of Surgical, Oncological and Oral Science (Di.Chir.On.S.), Section of Anesthesia, Analgesia, Intensive Care and Emergency, Policlinico Paolo Giaccone, University of Palermo, Italy.'}, {'ForeName': 'Jian-Xin', 'Initials': 'JX', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': ""D'Andrea"", 'Affiliation': 'Department of Anesthesiology, Intensive Care and Transplants, University Hospital St. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Calamai', 'Affiliation': 'AUSL Toscana Centro, Unit of Anesthesia and Resuscitation, San Giuseppe Hospital, Empoli, Italy.'}, {'ForeName': 'Ánxela Vidal', 'Initials': 'ÁV', 'LastName': 'González', 'Affiliation': 'Hospital Universitario Fundación Jiménez Díaz de Madrid, Madrid, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Roca', 'Affiliation': ""Critical Care Department, Valld'Hebron University Hospital, Valld'Hebron Research Institute, UniversitatAutònoma de Barcelona, Barcelona, Spain; CiberEnfermedadesRespiratorias (CibeRes), Instituto de Salud Carlos III, Madrid, Spain.""}, {'ForeName': 'Domenico Luca', 'Initials': 'DL', 'LastName': 'Grieco', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Catholic University of The Sacred Heart, IRCCS Fondazione Policlinico A. Gemelli, Rome, Italy.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jovaisa', 'Affiliation': 'Critical Care Service, Anaesthetics Division, Barking Havering and Redbridge University Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Bampalis', 'Affiliation': 'Intensive Care Unit, Larissa General Hospital, Larissa, Greece.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Becher', 'Affiliation': 'Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Battaglini', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy; Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.'}, {'ForeName': 'Huiqing', 'Initials': 'H', 'LastName': 'Ge', 'Affiliation': 'Sir Run Run Shaw Hospital,Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Luz', 'Affiliation': 'Intensive Care Department, Hospital da Mulher, Salvador, Bahia, Brazil; Intensive Care Department, Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': 'Sorbonne University, GRC 29, AP-HP, DMU DREAM, Department of Anesthesiology and critical care, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ranieri', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Transplants, University Hospital St. Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Guerin', 'Affiliation': 'Médecine Intensive-RéanimationGroupement Hospitalier Edouard Herriot, Université de Lyon Faculté de Médecine Lyon-Est, Lyon, France.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mancebo', 'Affiliation': 'Servei de Medicina Intensiva, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': 'Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy; Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Fumagalli', 'Affiliation': 'University of Milan-Bicocca, School of Medicine and Surgery, Monza, Italy; Anesthesia and Critical Care Service 1, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Brochard', 'Affiliation': 'Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Pathophysiology and Transplantation, University of Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Ca' Granda Maggiore PoliclinicoHospital, Milan, Italy.""}]",Chest,['10.1016/j.chest.2020.10.079']
2095,33197414,Using Intravenous Ibuprofen for Preventive Analgesia in Orthognathic Surgery.,"PURPOSE


Preventive analgesia aims to manage postoperative pain caused by nociceptive and central stimulation. The purpose of this study was to research the effect of a single-dose intravenous (IV) ibuprofen administration for preventive analgesia on postoperative pain management in orthognathic surgery.
MATERIALS AND METHODS


This prospective, double blind, and randomized study was performed on a total of 40 adult patients who planned to undergo bimaxillary osteotom, between 2018 and 2019. Thirty minutes before the surgery, 800 mg of IV ibuprofen and 100 mL of saline were applied to group 1 (ibuprofen; n = 20) and group 2 (placebo; n = 20), respectively. Postoperative analgesia was maintained with tramadol infusion via a patient-controlled analgesia pump. Postoperative visual analog scale (VAS) scores at 1, 3, 6, 9, 12, and 24 hours after surgery, rescue analgesic requirement, total tramadol dose, and adverse effects were recorded.
RESULTS


VAS scores between the groups at 1, 6, 9, and 24 hours and also the average of 24-hour VAS scores were similar (P > .05). However, VAS scores at 3 hours were significantly higher in group 2 (P = 0.06). Also, rescue analgesic intake of paracetamol was significantly higher in group 2 in the third hour (P = 0.08). Rescue analgesic intake of paracetamol and tramadol consumption during the postoperative 24 hours were similar (P > .05).
CONCLUSIONS


Using single-dose IV ibuprofen administration just before the orthognathic surgery for preventive analgesia reduced VAS scores and postoperative opioid consumption in patients. However, further studies in a large population are needed to estimate the preventive analgesia effect of ibuprofen in orthognathic surgery.",2020,Using single-dose IV ibuprofen administration just before the orthognathic surgery for preventive analgesia reduced VAS scores and postoperative opioid consumption in patients.,"['Orthognathic Surgery', 'patients', '40 adult patients who planned to undergo bimaxillary osteotom, between 2018 and 2019']","['Ibuprofen', 'single-dose intravenous (IV) ibuprofen', 'tramadol', 'IV ibuprofen and 100\xa0mL of saline were applied to group 1 (ibuprofen; n\xa0=\xa020) and group 2 (placebo', 'ibuprofen']","['Postoperative analgesia', 'postoperative pain management', 'VAS scores', 'VAS scores and postoperative opioid consumption', 'Postoperative visual analog scale (VAS) scores', 'rescue analgesic requirement, total tramadol dose, and adverse effects', 'Rescue analgesic intake of paracetamol and tramadol consumption', 'rescue analgesic intake of paracetamol', 'average of 24-hour VAS scores']","[{'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",40.0,0.111842,Using single-dose IV ibuprofen administration just before the orthognathic surgery for preventive analgesia reduced VAS scores and postoperative opioid consumption in patients.,"[{'ForeName': 'Dilek Günay', 'Initials': 'DG', 'LastName': 'Canpolat', 'Affiliation': 'Erciyes University, Department of Oral and Maxiloofacial Surgery, Associate Professor in Anesthesiology, Kayseri, Turkey. Electronic address: dgcanpolat@gmail.com.'}, {'ForeName': 'Yusuf Nuri', 'Initials': 'YN', 'LastName': 'Kaba', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Erciyes University Faculty of Dentistry, Kayseri, Turkey.'}, {'ForeName': 'Seher Orbay', 'Initials': 'SO', 'LastName': 'Yasl', 'Affiliation': 'Erciyes University, Department of Oral and Maxiloofacial Surgery, Associate Professor in Anesthesiology, Kayseri, Turkey.'}, {'ForeName': 'Ahmet Emin', 'Initials': 'AE', 'LastName': 'Demirbaş', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Erciyes University Faculty of Dentistry, Kayseri, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.10.029']
2096,33197451,Optical transmittance and ultrastructure of SMILE-derived lenticules subjected to three different preservative methods.,"PURPOSE


To investigate the optical transmittance and ultrastructure of small incision lenticule extraction (SMILE)-derived lenticules preserved via three different methods.
METHODS


A total of 90 lenticules obtained from myopic patients undergoing SMILE surgery were divided into control and experimental groups. Fresh lenticules served as the control. The preserved lenticules of the experimental group were randomly divided into three subgroups according to different storage conditions: anhydrous glycerol, silicone oil and allochroic silica gel groups. Optical transmittance was evaluated, histological changes were analysed by haematoxylin eosin (HE) staining, and collagen fibril densities and necrotic response were assessed via transmission electron microscopy (TEM) at 48 h, 14 days and 4 weeks.
RESULTS


After storage for 4 weeks, the mean percentage transmittance values in glycerol and silicone oil groups significantly decreased (P = 0.034 and P = 0.042, respectively), but the lenticules preserved in silica gel remained unchanged when compared with the control lenticules. In all the groups, HE staining results showed a regular arrangement of collagen fibers with a few keratocytes and several cavitation bubbles. TEM revealed that the fibril densities in the glycerol group (273.70 ± 31.42/μm 2 ) after 4 weeks were significant less than those in the other two groups (silicone oil, 335.20 ± 33.09/μm 2 ; silica gel, 371.80 ± 37.60/μm 2 ) and control group (340 ± 33.61/μm 2 ) (all P < 0.001). In each group, a few necrotic and apoptotic keratocytes were observed.
CONCLUSIONS


All the three agents, namely glycerol, silicone oil and silica gel, could be used for lenticule preservation. Silica gel facilitates better maintenance of optical transmittance than the other two agents.",2020,"After storage for 4 weeks, the mean percentage transmittance values in glycerol and silicone oil groups significantly decreased (P = 0.034 and P = 0.042, respectively), but the lenticules preserved in silica gel remained unchanged when compared with the control lenticules.",['90 lenticules obtained from myopic patients undergoing SMILE surgery'],"['Silica gel', 'namely glycerol, silicone oil and silica gel', 'storage conditions: anhydrous glycerol, silicone oil and allochroic silica gel groups', 'TEM']","['mean percentage transmittance values', 'fibril densities', 'haematoxylin eosin (HE) staining, and collagen fibril densities and necrotic response', 'Optical transmittance', 'lenticules preserved in silica gel', 'necrotic and apoptotic keratocytes']","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C2936385', 'cui_str': 'Silica Gel'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678118', 'cui_str': 'Transmission Electron Microscopy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0225328', 'cui_str': 'Fibril'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0018964', 'cui_str': 'Hematoxylin stain'}, {'cui': 'C0014448', 'cui_str': 'Eosine Yellowish'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C2936385', 'cui_str': 'Silica Gel'}, {'cui': 'C0229130', 'cui_str': 'Structure of corneal corpuscle'}]",,0.031964,"After storage for 4 weeks, the mean percentage transmittance values in glycerol and silicone oil groups significantly decreased (P = 0.034 and P = 0.042, respectively), but the lenticules preserved in silica gel remained unchanged when compared with the control lenticules.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Fu', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Meiyan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Aruma', 'Initials': 'A', 'LastName': 'Aruma', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China.'}, {'ForeName': 'Xingtao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Eye Institute and Department of Ophthalmology, Eye & ENT Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Myopia (Fudan University), Key Laboratory of Myopia, Chinese Academy of Medical Sciences, Shanghai, China; Shanghai Research Center of Ophthalmology and Optometry, Shanghai, China. Electronic address: doctzhouxingtao@163.com.'}]",Experimental eye research,['10.1016/j.exer.2020.108357']
2097,33197539,Carotid endarterectomy with modified eversion technique: results of a Single Center.,"BACKGROUND


Carotid endarterectomy (CEA) has a wide range of approaches, based on personal expertise and preference. We evaluated our outcome with CEA with modified eversion technique (meCEA) under local anaesthesia and whether surgeon' experience could influence it.
METHODS


at our Institution, 837 patients underwent CEA across 8 years. Although surgical technique was standardized, two groups were considered further: meCEA performed by a single Senior Operator (Group A) and meCEA performed by four young Consultants (Group B).
RESULTS


A selective shunting policy was needed in 5.1%, together with general anaesthesia. Overall operative time was 63.9 ± 15.1 minutes (61.4 ± 12.5 and 66 ± 16.9 minutes in Group A and Group B respectively; p < .001) and cross-clamp time 19.3±2.9 minutes (19.0±3.2 vs. 19.5±2.8, p=.009). At 30 days, 0.7% TIA and 0.8% strokes were recorded. No differences (p=N.S.) between the two study groups in terms of post-operative neurological complications, with postoperative ipsilateral strokes always < 1%. At a median imaging follow-up of 22.5 months, the overall percentage of restenosis was 3.7%, with no difference between the two groups (p= .954). Twenty-two patients (2.6%) underwent reintervention for significant restenosis, none of these had ipsilateral stroke or TIA. Freedom from reintervention for restenosis at 24 months was 97.9% in Group A and 95.9% in Group B, with no between-groups difference (p= .14). At the median survival follow-up of 37 months the overall survival rate at 24 months was 97.9%in Group A, and 97.9% in Group B, with no between-groups difference (p = .070).
CONCLUSIONS


In our experience, CEA with modified technique, is safe and achieves comparable outcomes to those of other established techniques. The reported short cross-clamp time, also in less experienced hands, is an additional strength.",2020,"No differences (p=N.S.) between the two study groups in terms of post-operative neurological complications, with postoperative ipsilateral strokes always < 1%.","['at our Institution, 837 patients underwent CEA across 8 years']","['Carotid endarterectomy (CEA', 'CEA with modified eversion technique (meCEA', 'Carotid endarterectomy with modified eversion technique']","['overall percentage of restenosis', 'ipsilateral stroke or TIA', 'Overall operative time', 'overall survival rate', 'post-operative neurological complications', 'median survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",837.0,0.0387999,"No differences (p=N.S.) between the two study groups in terms of post-operative neurological complications, with postoperative ipsilateral strokes always < 1%.","[{'ForeName': 'Gian Franco', 'Initials': 'GF', 'LastName': 'Veraldi', 'Affiliation': 'Department of Vascular Surgery.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Scorsone', 'Affiliation': 'Department of Vascular Surgery. Electronic address: lorenzo.scorsone@aovr.veneto.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Mastrorilli', 'Affiliation': 'Department of Vascular Surgery.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Bruno', 'Affiliation': 'Department of Vascular Surgery.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Macrì', 'Affiliation': 'Department of Vascular Surgery.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Criscenti', 'Affiliation': 'Department of Vascular Surgery.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Onorati', 'Affiliation': 'Department of Cardiac Surgery.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Faggian', 'Affiliation': 'Department of Cardiac Surgery.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bovo', 'Affiliation': 'University Hospital and Trust of Verona, University of Verona - School of Medicine, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mezzetto', 'Affiliation': 'Department of Vascular Surgery.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.09.047']
2098,33197559,Randomized Trial of Empagliflozin in Non-Diabetic Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND


Large clinical trials established the benefits of SGLT2 inhibitors in patients with diabetes and with heart failure with reduced ejection fraction (HFrEF). The early and significant improvement in clinical outcomes is likely explained by effects beyond a reduction in hyperglycemia OBJECTIVES: To assess the effect of empagliflozin on LV function and volumes, functional capacity and quality of life (QoL) in non-diabetic HFrEF patients.
METHODS


In this double-blind, placebo-controlled trial, non-diabetic HFrEF patients (n=84) were randomized to empagliflozin or placebo for six months. The primary endpoint was change in left ventricle end-diastolic volume (LVEDV) and left ventricle end-systolic volume (LVESV) assessed by cardiac magnetic resonance. Secondary endpoints included changes in LV mass, LVEF, peak oxygen consumption in the cardiopulmonary exercise test, 6-minute walk test, and quality of life RESULTS: Empagliflozin was associated with a significant reduction of LVEDV (-25.1±26.0 vs -1.5±25.4mL for empagliflozin vs placebo, respectively, p<0.001) and LVESV (-26.6±20.5 vs -0.5±21.9 mL for empagliflozin vs placebo, p<0.001). Empagliflozin was associated with reductions in LV mass (-17.8±31.9 vs 4.1±13.4 g, for empagliflozin vs placebo, respectively, p<0.001) and improvements in LVEF (6±4.2 vs -0.1±3.9 p<0.001). Patients who received empagliflozin had significant improvements in peak O2 consumption (1.1±2.6 vs -0.5±1.9mL/min/kg for empagliflozin vs placebo, respectively, p=0.017), oxygen uptake efficiency slope (111±267 vs -146±318, p<0.001), as well as in 6-minute walk test (81±64 vs -35±68 meters, p<0.001) and quality of life (KCCQ-12: 21±18 vs 2±15, p<0.001).
CONCLUSIONS


Empagliflozin administration to non-diabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for SGLT2 inhibitors in the treatment of HFrEF patients independently of their glycemic status.
CONDENSED ABSTRACT


In this double-blind, placebo-controlled, randomized EMPATROPISM clinical trial, empagliflozin administration to non-diabetic HFrEF patients on top of optimal medical treatment ameliorated cardiac remodeling, reduced LV volumes, decreased LV mass, increased LV systolic function, enhanced functional capacity (both peak oxygen consumption and 6-minute walk test), and improved quality of life when compared with placebo. The results of the EMPATROPISM trial support the use of SGLT2 inhibitors in the treatment of HFrEF patients independently of their diabetic status.",2020,"Patients who received empagliflozin had significant improvements in peak O2 consumption (1.1±2.6 vs -0.5±1.9mL/min/kg for empagliflozin vs placebo, respectively, p=0.017), oxygen uptake efficiency slope (111±267 vs -146±318, p<0.001), as well as in 6-minute walk test (81±64 vs -35±68 meters, p<0.001) and quality of life (KCCQ-12: 21±18 vs 2±15, p<0.001).
","['HFrEF patients independently of their diabetic status', 'Non-Diabetic Patients with Heart Failure and Reduced Ejection Fraction', 'non-diabetic HFrEF patients (n=84', 'patients with diabetes and with heart failure with reduced ejection fraction (HFrEF', 'non-diabetic HFrEF patients']","['empagliflozin', 'SGLT2 inhibitors', 'Empagliflozin', 'placebo', 'empagliflozin or placebo', 'empagliflozin vs placebo']","['changes in LV mass, LVEF, peak oxygen consumption in the cardiopulmonary exercise test, 6-minute walk test, and quality of life RESULTS', 'oxygen uptake efficiency slope', '6-minute walk test', 'LVEF', 'LV volumes, LV mass, LV systolic function, functional capacity, and quality of life', 'cardiac remodeling, reduced LV volumes, decreased LV mass, increased LV systolic function, enhanced functional capacity (both peak oxygen consumption and 6-minute walk test), and improved quality of life', 'LVESV', 'peak O2 consumption', 'change in left ventricle end-diastolic volume (LVEDV) and left ventricle end-systolic volume (LVESV) assessed by cardiac magnetic resonance', 'LVEDV', 'quality of life', 'LV function and volumes, functional capacity and quality of life (QoL', 'LV mass ']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007799', 'cui_str': 'Brain ventricle structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}]",84.0,0.535117,"Patients who received empagliflozin had significant improvements in peak O2 consumption (1.1±2.6 vs -0.5±1.9mL/min/kg for empagliflozin vs placebo, respectively, p=0.017), oxygen uptake efficiency slope (111±267 vs -146±318, p<0.001), as well as in 6-minute walk test (81±64 vs -35±68 meters, p<0.001) and quality of life (KCCQ-12: 21±18 vs 2±15, p<0.001).
","[{'ForeName': 'Carlos G', 'Initials': 'CG', 'LastName': 'Santos-Gallego', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'Ariana P', 'Initials': 'AP', 'LastName': 'Vargas-Delgado', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Requena', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Garcia-Ropero', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mancini', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pinney', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Macaluso', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Roque', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Sabatel-Perez', 'Affiliation': 'Atherothrombosis Research Unit.'}, {'ForeName': 'Anderly Rodriguez', 'Initials': 'AR', 'LastName': 'Cordero', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'M Urooj', 'Initials': 'MU', 'LastName': 'Zafar', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit.'}, {'ForeName': 'Icilma', 'Initials': 'I', 'LastName': 'Fergus', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Atallah-Lajam', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Johanna P', 'Initials': 'JP', 'LastName': 'Contreras', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Varley', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Pedro R', 'Initials': 'PR', 'LastName': 'Moreno', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Vivian M', 'Initials': 'VM', 'LastName': 'Abascal', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tamler', 'Affiliation': 'Division of EndocrinologyIcahn School of Medicine at Mount Sinai New York City, NY.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanz', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Mount Sinai Heart.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Badimon', 'Affiliation': 'Mount Sinai Heart; Atherothrombosis Research Unit. Electronic address: juan.badimon@mssm.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.11.008']
2099,33197560,Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization.,"BACKGROUND


Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors induce plaque regression and reduce the risk of coronary revascularization overall.
OBJECTIVES


To evaluate the ability of PCSK9 inhibitors to reduce the risk of complex coronary atherosclerosis requiring revascularization.
METHODS


FOURIER was a randomized trial of the PCSK9 inhibitor evolocumab vs. placebo in 27,564 patients with stable atherosclerosis on statin therapy followed for a median of 2.2 years. Clinical documentation of revascularization events was blindly reviewed to assess coronary anatomy and procedural characteristics. Complex revascularization was the composite of complex percutaneous coronary intervention (PCI) (as per previous analyses, >1 of: multivessel PCI, ≥3 stents, ≥3 lesions treated, bifurcation PCI, or total stent length >60 mm) or coronary artery bypass grafting surgery (CABG).
RESULTS


1,724 patients underwent coronary revascularization, including 1482 who underwent PCI, 296 who underwent CABG, and 54 both. Complex revascularization was performed in 632 (37%) patients. Evolocumab reduced the risk of any coronary revascularization by 22% (HR 0.78 [0.71-0.86]; P<0.001), simple PCI by 22% (HR 0.78, [0.70-0.88]; P<0.001), complex PCI by 33% (HR 0.67 [0.54-0.84]; P<0.001), CABG by 24% (HR 0.76 [0.60-0.96]; P=0.019), and complex revascularization by 29% (HR 0.71 [0.61-0.84]; P<0.001). The magnitude of the risk reduction with evolocumab in complex revascularization tended to increase over time (20%, 36%, and 41% risk reductions in 1 st , 2 nd  and beyond 2 nd  year).
CONCLUSIONS


Adding evolocumab to statin therapy significantly reduced the risk of developing complex coronary disease requiring revascularization, including complex PCI and CABG individually.",2020,"Evolocumab reduced the risk of any coronary revascularization by 22% (HR 0.78 [0.71-0.86]; P<0.001), simple PCI by 22% (HR 0.78, [0.70-0.88]; P<0.001), complex PCI by 33% (HR 0.67 [0.54-0.84]; P<0.001), CABG by 24% (HR 0.76 [0.60-0.96]; P=0.019), and complex revascularization by 29% (HR 0.71 [0.61-0.84]; P<0.001).","['27,564 patients with stable atherosclerosis on statin therapy followed for a median of 2.2 years', '1,724 patients underwent coronary revascularization, including 1482 who underwent PCI, 296 who underwent CABG, and 54 both']","['Evolocumab', 'coronary artery bypass grafting surgery (CABG', 'PCSK9 inhibitor evolocumab vs. placebo', 'PCSK9 inhibitors', 'complex percutaneous coronary intervention (PCI']","['Complex Coronary Disease Requiring Revascularization', 'simple PCI', 'Complex revascularization', 'risk of any coronary revascularization', 'risk of developing complex coronary disease requiring revascularization', 'complex PCI', 'complex revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4522007', 'cui_str': 'PCSK9 inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",27564.0,0.0465221,"Evolocumab reduced the risk of any coronary revascularization by 22% (HR 0.78 [0.71-0.86]; P<0.001), simple PCI by 22% (HR 0.78, [0.70-0.88]; P<0.001), complex PCI by 33% (HR 0.67 [0.54-0.84]; P<0.001), CABG by 24% (HR 0.76 [0.60-0.96]; P=0.019), and complex revascularization by 29% (HR 0.71 [0.61-0.84]; P<0.001).","[{'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Oyama', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.""}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Hospital Israelita Albert Einsteinand Instituto do Coraçao da Faculdade de Medicina da USP, Sao Paulo, Brazil.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Fagundes', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Division of Cardiology, Vienna General Hospital and Medical University of Vienna, Austria.""}, {'ForeName': 'Minao', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hamer', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: bbergmark@bwh.harvard.edu.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.11.011']
2100,33200891,Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.,"BACKGROUND


The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied.
METHODS


We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m 2  of body-surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. The trial ended early owing to loss of funding.
RESULTS


Of 19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the placebo group, and followed for a median of 16 months. The rate of primary end-point events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001). The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35). For the original coprimary end point of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio was 0.84 (95% CI, 0.72 to 0.99); for the original coprimary end point of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, the hazard ratio was 0.77 (95% CI, 0.66 to 0.91). Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagliflozin than with placebo.
CONCLUSIONS


In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but was associated with adverse events. (Funded by Sanofi and Lexicon Pharmaceuticals; SCORED ClinicalTrials.gov number, NCT03315143.).",2020,"The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35).","['19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the', 'patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m 2  of body-surface area), and risks for cardiovascular disease', 'patients with diabetes and chronic kidney disease', 'Patients with Diabetes and Chronic Kidney Disease', 'patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied']","['sotagliflozin or placebo', 'sodium-glucose cotransporter 2 inhibitors such as sotagliflozin', 'placebo', 'sotagliflozin', 'Sotagliflozin']","['composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure', 'rate of primary end-point events', 'death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio', 'Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis', 'total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure', 'rate of deaths from cardiovascular causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0026946', 'cui_str': 'Mycosis'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",10584.0,0.420389,"The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Julia B', 'Initials': 'JB', 'LastName': 'Lewis', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Clifford J', 'Initials': 'CJ', 'LastName': 'Bailey', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Díaz', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C., B.M.S.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); the State University of New York Downstate School of Public Health, Brooklyn (M.S.); the University of Michigan, Ann Arbor (B.P.); Li Ka Shing Knowledge Institute and the Division of Endocrinology and Metabolism, St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences, University of Toronto (L.A.L.), and the Division of Nephrology (D.Z.I.C.) and the Cardiovascular Division, Department of Medicine, Women's College Hospital and Peter Munk Cardiac Centre (J.A.U.), University Health Network, University of Toronto - all in Toronto; the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University Medical Center, Nashville (J.B.L., J.P.D.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); the Section of Endocrinology, Yale School of Medicine, New Haven, CT (S.E.I.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (M.N.K.); the School of Life and Health Sciences, Aston University, Birmingham (C.J.B.), and the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.) - both in the United Kingdom; the Department of Medicine, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris (P.G.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2030186']
2101,33200892,Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure.,"BACKGROUND


Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure or death from cardiovascular causes among patients with stable heart failure. However, the safety and efficacy of SGLT2 inhibitors when initiated soon after an episode of decompensated heart failure are unknown.
METHODS


We performed a multicenter, double-blind trial in which patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure were randomly assigned to receive sotagliflozin or placebo. The primary end point was the total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events). The trial ended early because of loss of funding from the sponsor.
RESULTS


A total of 1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the placebo group) and were followed for a median of 9.0 months; the first dose of sotagliflozin or placebo was administered before discharge in 48.8% and a median of 2 days after discharge in 51.2%. Among these patients, 600 primary end-point events occurred (245 in the sotagliflozin group and 355 in the placebo group). The rate (the number of events per 100 patient-years) of primary end-point events was lower in the sotagliflozin group than in the placebo group (51.0 vs. 76.3; hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.85; P<0.001). The rate of death from cardiovascular causes was 10.6 in the sotagliflozin group and 12.5 in the placebo group (hazard ratio, 0.84; 95% CI, 0.58 to 1.22); the rate of death from any cause was 13.5 in the sotagliflozin group and 16.3 in the placebo group (hazard ratio, 0.82; 95% CI, 0.59 to 1.14). Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%). The percentage of patients with hypotension was similar in the sotagliflozin group and the placebo group (6.0% and 4.6%, respectively), as was the percentage with acute kidney injury (4.1% and 4.4%, respectively). The benefits of sotagliflozin were consistent in the prespecified subgroups of patients stratified according to the timing of the first dose.
CONCLUSIONS


In patients with diabetes and recent worsening heart failure, sotagliflozin therapy, initiated before or shortly after discharge, resulted in a significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo. (Funded by Sanofi and Lexicon Pharmaceuticals; SOLOIST-WHF ClinicalTrials.gov number, NCT03521934.).",2020,"Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%).","['1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the', 'patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure', 'patients with stable heart failure', 'Patients with Diabetes and Recent Worsening Heart Failure']","['sotagliflozin or placebo', 'SGLT2 inhibitors', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors', 'placebo', 'sotagliflozin', 'Sotagliflozin']","['total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events', 'Diarrhea', 'percentage with acute kidney injury', 'percentage of patients with hypotension', 'safety and efficacy', 'severe hypoglycemia', 'total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure', 'rate of death from cardiovascular causes', 'rate of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",1222.0,0.570115,"Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%).","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Julia B', 'Initials': 'JB', 'LastName': 'Lewis', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Komajda', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Wilcox', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': ""From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G.S.), and Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph (M.K.), Paris; Li Ka Shing Knowledge Institute (L.A.L., S.V.) and the Divisions of Endocrinology and Metabolism (L.A.L.) and Cardiac Surgery (S.V.), St. Michael's Hospital, and the Departments of Medicine and Nutritional Sciences (L.A.L) and Surgery and Pharmacology and Toxicology (S.V.), University of Toronto, Toronto; University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.), and Lexicon Pharmaceuticals, The Woodlands (P.L.) - both in Texas; Vanderbilt University, Nashville (J.B.L.); the Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (M.C.R.); University of Groningen-University Medical Center Groningen, Groningen, the Netherlands (A.A.V); Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.); Karolinska Institutet, Stockholm (L.H.L.); Yale University, New Haven, CT (J.M.T.); Georgetown University, Washington, DC (C.S.W.); Wroclaw Medical University, Wroclaw, Poland (P.P.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L.); and the University of Michigan, Ann Arbor (B.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2030183']
2102,33197659,The Buteyko breathing technique in children with asthma: a randomized controlled pilot study.,"BACKGROUND


Evidence supports the Buteyko breathing technique (BBT) as reducing medication and improving control and quality of life in adults with asthma, but having minimal impact on spirometry. For children with asthma, evidence addressing the utility of BBT is sparse. We evaluated the effectiveness of BBT in managing various aspects of asthma in children.
METHODS


Thirty-two children with partly controlled asthma (age 6-15 years, 66% male) were randomized to either Treatment as Usual (TAU) or TAU combined with Buteyko training (Buteyko group, BG). Children in the BG received an intensive five-day training followed by three months of home practice. Primary outcome was bronchodilator reduction. Secondary outcomes were changes in physiological parameters FEV1_AR (at rest), FEV1_ER (after ergometry), FEV1_BR (after bronchospasmolysis), corticosteroid use, FeNO, SpO2, breath-hold test and questionnaire data [Asthma Control Questionnaire and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)]. All measures were collected at Baseline and a three-month follow-up.
RESULTS


For the primary outcome, no significant between-group difference was found. Regarding the secondary outcomes, children receiving treatment augmented with BBT revealed significantly greater improvement at the follow-up than those receiving TAU for FEV1_AR (p = .04, d=-0.50), FEV1_ER (p = .02, d=-0.52), and the emotional function subscale of the PACQLQ (p < .01, d = 1.03). No between-group differences were found for the remaining secondary measures of outcome.
CONCLUSIONS


Our preliminary findings suggest that the addition of BBT to treatment as usual for children with asthma enhances outcomes with respect to spirometry and parental emotional function but does not lead to reductions in medication, at least over the short term.",2020,"No between-group differences were found for the remaining secondary measures of outcome.
","['asthma in children', 'children with asthma', 'Thirty-two children with partly controlled asthma (age 6-15 years, 66% male', 'adults with asthma']","['Buteyko breathing technique (BBT', 'Usual (TAU) or TAU combined with Buteyko training (Buteyko group, BG', 'Buteyko breathing technique', 'BBT']","['emotional function subscale of the PACQLQ', ""changes in physiological parameters FEV1_AR (at rest), FEV1_ER (after ergometry), FEV1_BR (after bronchospasmolysis), corticosteroid use, FeNO, SpO2, breath-hold test and questionnaire data [Asthma Control Questionnaire and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ"", 'bronchodilator reduction']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",32.0,0.0982378,"No between-group differences were found for the remaining secondary measures of outcome.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vagedes', 'Affiliation': ""ARCIM Institute, Filderstadt, Germany; Department of Pediatrics, Filderklinik, Filderstadt, Germany; Department of Neonatology, Children's Hospital, University of Tübingen, Tübingen, Germany. Electronic address: j.vagedes@arcim-institute.de.""}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Helmert', 'Affiliation': 'ARCIM Institute, Filderstadt, Germany.'}, {'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Kuderer', 'Affiliation': 'ARCIM Institute, Filderstadt, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Vagedes', 'Affiliation': 'ARCIM Institute, Filderstadt, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Wildhaber', 'Affiliation': 'Department of Pediatrics, Fribourg Hospital HFR, Fribourg, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Andrasik', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN, USA.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102582']
2103,33197662,"The Effects of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy: An Open Label Quasi-Randomized Controlled Pilot Study.","OBJECTIVES


The current study evaluated the effects of peppermint oil on the frequency of nausea, vomiting, retching, and the severity of nausea in cancer patients undergoing chemotherapy.
DESIGN


A quasi-randomized controlled study.
SETTING


Patients were recruited from the ambulatory chemotherapy unit of a public hospital located (Batman, Turkey) between September 2017 and September 2018.
INTERVENTIONS


The participants in the intervention group applied one drop the aromatic mixture on the spot between their upper lip and their nose, three times a day for the five days following chemotherapy administration, in addition to the routine antiemetic treatment. Participants in the control group underwent only the routine antiemetic treatment. Main outcome measures VAS-the severity of nausea and the Index of Nausea, Vomiting, and Retching.
RESULTS


The VAS nausea score was significantly lower after peppermint oil applying in the patients receiving Folfirinox (treatment effect (mean dif.): 4.00±2.28; P<0.001), Paclitaxel-Trastuzumab (treatment effect (mean dif.): 1.70±0.90; P=0.014), Carboplatin-Paclitaxel (treatment effect (mean dif.): 3.71±1.41; P<0.001), and Cyclophosphamide-Adriamycin (treatment effect (mean dif.): 1.41±0.73; P=0.005) excluding cisplatin scedule (treatment effect (mean dif.): 0.56±2,18; P=0.642). We detected a statistical significant difference in the change in frequency of nausea, vomiting, retching in the other all schedules excluding cisplatin schedule (P<0.05).
CONCLUSIONS


The peppermint oil was significantly reduced the frequency of nausea, vomiting, retching and the severity of nausea in cancer patients undergoing chemotherapy. Therefore, usage of peppermint oil together with antiemetics after chemotherapy with moderate and low emetic risk may be recommended to cope with CINV.",2020,"The peppermint oil was significantly reduced the frequency of nausea, vomiting, retching and the severity of nausea in cancer patients undergoing chemotherapy.","['Cancer Patients', 'cancer patients undergoing chemotherapy', 'Patients were recruited from the ambulatory chemotherapy unit of a public hospital located (Batman, Turkey) between September 2017 and September 2018']","['Undergoing Chemotherapy', 'Carboplatin-Paclitaxel', 'Peppermint Oil', 'Cyclophosphamide-Adriamycin', 'Paclitaxel-Trastuzumab', 'peppermint oil']","['frequency of nausea, vomiting, retching, and the severity of nausea', 'Nausea, Vomiting and Retching', 'frequency of nausea, vomiting, retching', 'VAS-the severity of nausea and the Index of Nausea, Vomiting, and Retching', 'frequency of nausea, vomiting, retching and the severity of nausea', 'VAS nausea score']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1276154', 'cui_str': 'Ambulatory chemotherapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0402655', 'cui_str': 'Batman'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0070325', 'cui_str': 'Peppermint oil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0297702,"The peppermint oil was significantly reduced the frequency of nausea, vomiting, retching and the severity of nausea in cancer patients undergoing chemotherapy.","[{'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Efe Ertürk', 'Affiliation': 'Department of Nursing, Batman University Health College, Batman, Turkey. Electronic address: nuriye_efe@hotmail.com.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Taşcı', 'Affiliation': 'Department of Internal Medicine Nursing, Erciyes University Faculty of Health Science, Kayseri, Turkey.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102587']
2104,33197676,Wet-cupping induces anti-inflammatory action in response to vigorous exercise among martial arts athletes: A pilot study.,"PURPOSE


The aim of the present study was to investigate potential anti-inflammatory effects of wet-cupping prior to a moderate-to-vigorous exercise test among martial arts athletes.
METHODS


Twenty-one male karate athletes voluntarily participated in this study and were randomly divided into 3 groups: vigorous exercise (VE, n = 7), cupping (CT, n = 7) and cupping plus vigorous exercise (VECT, n = 7). Participants in exercise groups performed an exercise test while participants in CT received cupping therapy, and participants in VECT received cupping therapy plus exercise. Inflammatory markers (i.e., interlukin-6, IL-6, and tumor necrosis factor-α, TNF-α) were assessed prior to, immediately, 30 min, and 24 h after cupping therapy, vigorous exercise test, and their combination.
RESULTS


IL-6 values were significantly lower immediately after cupping intervention in CT as compared to baseline (P < 0.025). IL-6 significantly increased immediately and 30 min post-exercise in VE in comparison with baseline (P < 0.025). IL-6 was also significantly higher at 24 h post-exercise in CTVE as compared to baseline (P < 0.025). TNF-α values were significantly lower in CT as compared to VE and CTVE at immediately and 30 min post-exercise (P < 0.01). TNF-α significantly decreased immediately and 30 min after cupping intervention in CT as compared to baseline (P < 0.01). Conversely, TNF-α significantly increased immediately after exercise in VE as compared to baseline (P < 0.025). TNF-α also significantly increased at 30 min and 24 h post-exercise in CTVE in comparison with baseline (P < 0.025).
CONCLUSION


Our findings showed that exercise-induced augmentation in inflammatory markers were lower in athletes who received cupping therapy, suggesting such therapy may be an avenue to mitigate the inflammatory response to vigorous exercise among martial arts athletes. A large-scale clinical study is needed to confirm the findings of the present study.",2020,TNF-α values were significantly lower in CT as compared to VE and CTVE at immediately and 30 min post-exercise (P < 0.01).,"['Twenty-one male karate athletes voluntarily participated', 'martial arts athletes']","['cupping therapy', 'wet-cupping prior to a moderate-to-vigorous exercise test', 'vigorous exercise (VE, n = 7), cupping (CT, n = 7) and cupping plus vigorous exercise (VECT', 'Wet-cupping', 'TNF-α', 'exercise test while participants in CT received cupping therapy, and participants in VECT received cupping therapy plus exercise']","['Inflammatory markers (i.e., interlukin-6, IL-6, and tumor necrosis factor-α, TNF-α', 'IL-6 values', 'IL-6', 'TNF-α values', 'TNF-α']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0079654', 'cui_str': 'Karate'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0079801', 'cui_str': 'Martial arts'}]","[{'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",21.0,0.0327562,TNF-α values were significantly lower in CT as compared to VE and CTVE at immediately and 30 min post-exercise (P < 0.01).,"[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Ekrami', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, University of Shahid Beheshti, Tehran, Iran. Electronic address: narges.ekrami@gmail.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadian', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nourshahi', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, University of Shahid Beheshti, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Shakouri G', 'Affiliation': 'School of Industrial and Systems Engineering, University of Tehran, Tehran, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102611']
2105,33197677,Effects of a mind-body program on symptoms of depression and perceived stress among adults with neurofibromatosis type 2 who are deaf: A live-video randomized controlled trial.,"INTRODUCTION


Neurofibromatosis type 2 (NF2) is a rare, progressive and incurable genetic disorder associated with progressive hearing loss and eventual deafness. As a group, patients with NF report high levels of stress and depressive symptoms. However, no studies have explored improvement in these symptoms after psychosocial interventions. We have previously shown that a mind-body program tailored to adults with NF2 who are deaf (the Relaxation Response and Resiliency Program for Deaf NF2, d3RP-NF2) improves quality of life and resiliency over and above a Health Enhancement program when both are delivered via live-video and assisted by Communication Access Realtime Translation (CART). Here we tested the effects of the programs on depression and perceived stress.
METHODS


Forty-five patients with NF2 and significant hearing loss were randomized to the d3RP-NF2 or Health-Enhancement program and completed measures of depression (PHQ-9) and perceived stress (PSS-10) at baseline, post-intervention, and six-month follow-up.
RESULTS


Patients randomized to the d3RP-NF2 program, but not to the control condition, experienced significant decreases on both measures from baseline to post-test, which were maintained at follow-up (within group tests). However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests).
CONCLUSION


Results provide the first evidence of improvement in symptoms of depression and perceived stress among deaf patients living with NF2 who participate in a virtual mind-body program.",2020,"However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests).
","['Forty-five patients with NF2 and significant hearing loss', 'adults with neurofibromatosis type 2 who are deaf']","['mind-body program', 'd3RP-NF2 or Health-Enhancement program and completed measures of depression (PHQ-9) and perceived stress (PSS-10) at baseline, post-intervention, and six-month follow-up']","['depression and perceived stress', 'stress and depressive symptoms', 'symptoms of depression and perceived stress']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",45.0,0.0320809,"However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, USA; Harvard Medical School, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, USA; Harvard Medical School, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Funes', 'Affiliation': 'Division of Neuropsychiatry, Department of Psychiatry & Athinoula A Martinos Center for Biomedical Imaging, Massachusetts General Hospital, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, USA; Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, USA; Harvard Medical School, USA. Electronic address: avranceanu@mgh.harvard.edu.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102581']
2106,33197997,Comparison of del Nido and histidine-tryptophan-ketoglutarate cardioplegia solutions in pediatric patients undergoing open heart surgery: A prospective randomized clinical trial.,"OBJECTIVES


We conducted a prospective randomized controlled trial to compare del Nido (DN) and histidine-tryptophan-ketoglutarate (HTK) cardioplegia solution in pediatric patients undergoing intracardiac tetralogy of Fallot repair.
METHODS


One hundred consecutive patients 12 years of age or younger, undergoing intracardiac repair of tetralogy of Fallot were randomized into DN (n = 50) and HTK (n = 50) groups. Cardioplegia strategy consisted of a single dose of DN (20 mL/kg) or HTK (6 mL/kg/min for 6 minutes). Primary outcome was cardiac index (CI). Secondary outcomes were ventricular arrhythmias post cross-clamp release, time to peripheral rewarming, duration of mechanical ventilation, inotropic score, intensive care unit and hospital stay, and serum levels of troponin-I, interleukin-6, and tumor necrosis factor-α. Ultrastructural changes in the myocardium were assessed.
RESULTS


CI was significantly higher in the DN group compared with the HTK group at 6 (P = .005) and 24 hours (P < .001) after surgery. It was on an average 0.44 L/min/m 2  higher in the DN group at any time point (P = .004). Time for complete cessation of electrical activity was longer in the HTK group (P = .01) and more patients in the HTK group had ventricular arrhythmias post cross-clamp release (P = .03). Duration of mechanical ventilation (P = .006), intensive care unit stay (P = .05), and hospital stay (P < .001) were lower in the DN group. Patients in the DN group had lower troponin I levels 24 hours after cardiopulmonary bypass (P < .001). Electron microscopic studies showed more myocardial edema (P = .02) and myofibrillar disarray (P = .04) in the HTK group along with lower glycogen stores (P = .04). DN cardioplegia was more cost-effective than HTK cardioplegia (P < .001).
CONCLUSIONS


DN cardioplegia was associated with better preservation of CI, less duration of mechanical ventilation, shorter intensive care unit and hospital stays, lower inotropic scores, and less release of troponin-I. Electron microscopy showed less myocardial edema and better preservation of the myofibrillar architecture and glycogen stores in the DN group.",2019,Patients in the DN group had lower troponin,"['pediatric patients undergoing intracardiac tetralogy of Fallot repair', 'One hundred consecutive patients 12\xa0years of age or younger, undergoing intracardiac repair of tetralogy of Fallot', 'pediatric patients undergoing open heart surgery']","['DN cardioplegia', 'del Nido and histidine-tryptophan-ketoglutarate cardioplegia solutions', 'del Nido (DN) and histidine-tryptophan-ketoglutarate (HTK) cardioplegia solution', 'HTK', 'HTK cardioplegia']","['myofibrillar disarray', 'cardiac index (CI', 'hospital stay', 'lower troponin', 'myocardial edema', 'intensive care unit stay', 'preservation of CI, less duration of mechanical ventilation, shorter intensive care unit and hospital stays, lower inotropic scores', 'myocardial edema and better preservation of the myofibrillar architecture and glycogen stores', 'Duration of mechanical ventilation', 'ventricular arrhythmias post cross-clamp release, time to peripheral rewarming, duration of mechanical ventilation, inotropic score, intensive care unit and hospital stay, and serum levels of troponin-I, interleukin-6, and tumor necrosis factor-α. Ultrastructural changes in the myocardium', 'electrical activity', 'ventricular arrhythmias post cross-clamp release']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729936', 'cui_str': 'Cardiac chamber structure'}, {'cui': 'C0397326', 'cui_str': 'Repair of tetralogy of Fallot'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0018791', 'cui_str': 'Induced cardioplegia'}, {'cui': 'C0019602', 'cui_str': 'Histidine'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0007200', 'cui_str': 'cardioplegia solutions'}]","[{'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C1610068', 'cui_str': 'Myocardial oedema'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0077401', 'cui_str': 'Troponin I'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}]",100.0,0.170732,Patients in the DN group had lower troponin,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, New Delhi, India. Electronic address: sachintalwar@hotmail.com.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Makhija', 'Affiliation': 'Department of Cardiac Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Poonam Malhotra', 'Initials': 'PM', 'LastName': 'Kapoor', 'Affiliation': 'Department of Cardiac Anesthesiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Airan', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2018.09.140']
2107,33198003,Esophageal squamous cell carcinoma patients with positive lymph nodes benefit from extended radical lymphadenectomy.,"BACKGROUND


The usefulness of lymphadenectomy for advanced esophageal cancer is unclear. A post-hoc subgroup analysis involving a randomized controlled trial was performed to compare the long-term survival of patients with esophageal cancer and lymph nodes metastasis (LNM) after extended lymphadenectomy via the right thoracic approach with that of those undergoing limited lymphadenectomy via the left thoracic approach.
METHODS


Between May 2010 and July 2012, 300 patients with thoracic esophageal cancer were randomized to undergo esophagectomy through either the right or left thoracic approach. Of these patients, 129 with esophageal squamous cell carcinoma and LNM by postoperative pathology were included in this analysis. Disease-free survival and overall survival (OS) were compared between the extended (n = 64) and limited (n = 65) lymphadenectomy groups after 5 years' follow-up. Cox regression analysis was used to identify the factors associated with OS.
RESULTS


The 5-year disease-free survival rates were 40% and 26% in the extended and limited lymphadenectomy groups, respectively (hazard ratio [HR], 1.542; 95% confidence interval [CI], 1.018-2.335; P = .037), and the 5-year OS rates were 51% and 31%, respectively (HR, 1.719; 95% CI, 1.111-2.660; P = .013). The extended lymphadenectomy group had less locoregional recurrence (HR, 0.583; 95% CI, 0.375-0.908; P = .015) and delayed distant metastasis (HR, 1.407; 95% CI, 0.914-2.167; P = .115). Reduced OS was associated with limited lymphadenectomy, R1/2 resection margins, TNM stage IV, and lack of postoperative adjuvant therapy, as per the Cox regression analysis.
CONCLUSIONS


Improved long-term survival was observed in patients with esophageal squamous cell carcinoma and LNM after extended lymphadenectomy via the right thoracic approach.",2019,"The 5-year disease-free survival rates were 40% and 26% in the extended and limited lymphadenectomy groups, respectively (hazard ratio [HR], 1.542; 95% confidence interval [CI], 1.018-2.335; P = .037), and the 5-year OS rates were 51% and 31%, respectively (HR, 1.719; 95% CI, 1.111-2.660; P = .013).","['129 with esophageal squamous cell carcinoma and LNM by postoperative pathology', 'patients with esophageal squamous cell carcinoma and LNM after extended lymphadenectomy via the right thoracic approach', 'Between May 2010 and July 2012, 300 patients with thoracic esophageal cancer', 'advanced esophageal cancer', 'patients with esophageal cancer and lymph nodes metastasis (LNM) after extended lymphadenectomy via the right thoracic approach with that of those undergoing limited lymphadenectomy via the left thoracic approach', 'Esophageal squamous cell carcinoma patients with positive lymph nodes benefit from extended']","['lymphadenectomy', 'radical lymphadenectomy', 'esophagectomy through either the right or left thoracic approach']","['locoregional recurrence', 'delayed distant metastasis', 'Reduced OS', '5-year OS rates', '5-year disease-free survival rates', 'Disease-free survival and overall survival (OS', 'Improved long-term survival']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]","[{'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0193854', 'cui_str': 'Radical excision of lymph nodes'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",300.0,0.392778,"The 5-year disease-free survival rates were 40% and 26% in the extended and limited lymphadenectomy groups, respectively (hazard ratio [HR], 1.542; 95% confidence interval [CI], 1.018-2.335; P = .037), and the 5-year OS rates were 51% and 31%, respectively (HR, 1.719; 95% CI, 1.111-2.660; P = .013).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.'}, {'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China. Electronic address: hqchen1@yahoo.com.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2018.11.094']
2108,33198147,Brief Relaxation Practice Induces Significantly More Prefrontal Cortex Activation during Arithmetic Tasks Comparing to Viewing Greenery Images as Revealed by Functional Near-Infrared Spectroscopy (fNIRS).,"BACKGROUND


There is little understanding on how brief relaxation practice and viewing greenery images would affect brain responses during cognitive tasks. In the present study, we examined the variation in brain activation of the prefrontal cortex during arithmetic tasks before and after viewing greenery images, brief relaxation practice, and control task using functional near-infrared spectroscopy (fNIRS).
METHOD


This randomized controlled study examined the activation patterns of the prefrontal cortex (PFC) in three groups of research participants who were exposed to viewing greenery images ( n  = 10), brief relaxation practice ( n  = 10), and control task ( n  = 11). The activation pattern of the PFC was measured pre- and post-intervention using a portable fNIRS device and reported as mean total oxygenated hemoglobin (HbO μm). Primary outcome of the study is the difference in HbO μm between post- and pre-intervention readings during a cognitive task that required the research participants to perform arithmetic calculation.
RESULTS


In terms of intervention-related differences, there was significant difference in average HbO μm when performing arithmetic tasks before and after brief relaxation practice ( p  < 0.05). There were significant increases in average HbO μm in the right frontopolar cortex ( p  = 0.029), the left frontopolar cortex ( p  = 0.01), and the left orbitofrontal cortex ( p  = 0.033) during arithmetic tasks after brief relaxation practice. In contrast, there were no significant differences in average HbO μm when performing arithmetic tasks before and after viewing greenery images ( p  > 0.05) and the control task ( p  > 0.05).
CONCLUSION


Our preliminary findings show that brief relaxation practice but not viewing greenery images led to significant frontal lobe activation during arithmetic tasks. The present study demonstrated, for the first time, that there was an increase in activation in neuroanatomical areas including the combined effort of allocation of attentional resources, exploration, and memory performance after the brief relaxation practice. Our findings suggest the possibility that the right frontopolar cortex, the left frontopolar cortex, and the left orbitofrontal cortex may be specifically associated with the benefits of brief relaxation on the brain.",2020,"There were significant increases in average HbO μm in the right frontopolar cortex ( p  = 0.029), the left frontopolar cortex ( p  = 0.01), and the left orbitofrontal cortex ( p  = 0.033) during arithmetic tasks after brief relaxation practice.","['three groups of research participants who were exposed to viewing greenery images ( n  = 10), brief relaxation practice ( n  = 10), and control task ( n  = 11']",['prefrontal cortex (PFC'],"['left frontopolar cortex', 'left orbitofrontal cortex', 'Prefrontal Cortex Activation during Arithmetic Tasks', 'mean total oxygenated hemoglobin (HbO μm', 'HbO μm between post- and pre-intervention readings during a cognitive task that required the research participants to perform arithmetic calculation', 'frontal lobe activation', 'average HbO μm']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}]",,0.0150558,"There were significant increases in average HbO μm in the right frontopolar cortex ( p  = 0.029), the left frontopolar cortex ( p  = 0.01), and the left orbitofrontal cortex ( p  = 0.033) during arithmetic tasks after brief relaxation practice.","[{'ForeName': 'Zhisong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Olszewska-Guizzo', 'Affiliation': 'Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore 117599, Singapore.'}, {'ForeName': 'Syeda Fabeha', 'Initials': 'SF', 'LastName': 'Husain', 'Affiliation': 'Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore 117599, Singapore.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bose', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Jongkwan', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'OBELAB, Inc., Seoul 06212, Korea.'}, {'ForeName': 'Wanqiu', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National University of Singapore (Chongqing) Research Institute, Chongqing 401123, China.'}, {'ForeName': 'Jiayun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Bach', 'Initials': 'B', 'LastName': 'Xuan Tran', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi 100000, Vietnam.'}, {'ForeName': 'Bokun', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Science and Technology Promotion Bureau, Chongqing Liangjiang New Area Administration Committee, Chongqing 201205, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xuan', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Pinjia', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Maomao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Cyrus S H', 'Initials': 'CSH', 'LastName': 'Ho', 'Affiliation': 'Department of Psychological Medicine, National University Hospital, Singapore 119074, Singapore.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ho', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17228366']
2109,33198148,Prospective Trial of CPAP in Community-Dwelling Adults with Down Syndrome and Obstructive Sleep Apnea Syndrome.,"Adults with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA), but the effectiveness and acceptability of continuous positive airway pressure treatment (CPAP) in this group has rarely been formally assessed. This study was designed as a pilot randomised, parallel controlled trial for one month, continuing as an uncontrolled cohort study whereby the control group also received the intervention. Symptomatic, community-dwelling DS individuals exhibiting ≥10 apnoeas/hypopneas per hour in bed on a Type 3 home sleep study were invited to participate in this study, with follow-up at 1, 3, 6, and 12 months from baseline. Measurements of sleepiness, behaviour, cognitive function and general health were undertaken; the primary outcome was a change in the pictorial Epworth Sleepiness Scale (pESS) score. Twenty-eight participants (19 male) were enrolled: age 28 ± 9 year; body mass index 31.5 ± 7.9 kg/m 2 ; 39.6 ± 32.2 apnoeas/hypopneas per hour in bed; pESS 11 ± 6/24. The pilot randomised controlled trial at one month demonstrated no change between the groups. At 12 months, participant ( p  = 0.001) pESS and Disruptive ( p  < 0.0001), Anxiety/Antisocial ( p  = 0.024), and Depressive ( p  = 0.008) behaviour scores were reduced compared to baseline. Improvement was noted in verbal ( p  = 0.001) and nonverbal intelligence scores ( p  = 0.011). General health scores also improved ( p  = 0.02). At the end of the trial, 19 participants continued on treatment. Use of CPAP in adults with DS and OSA led to a number of significant, sustained improvements in sleepiness and behavioural/emotional outcomes at 12 months.",2020,Improvement was noted in verbal ( p  = 0.001) and nonverbal intelligence scores ( p  = 0.011).,"['adults with DS and OSA', 'Community-Dwelling Adults with Down Syndrome and Obstructive Sleep Apnea Syndrome', 'Adults with Down syndrome (DS', 'Twenty-eight participants (19 male) were enrolled: age 28 ± 9 year; body mass index 31.5 ± 7.9 kg/m 2 ; 39.6 ± 32.2 apnoeas/hypopneas per hour in bed; pESS 11 ± 6/24', 'Symptomatic, community-dwelling DS individuals exhibiting ≥10 apnoeas/hypopneas per hour in bed on a Type 3 home sleep study']","['CPAP', 'continuous positive airway pressure treatment (CPAP']","['Measurements of sleepiness, behaviour, cognitive function and general health', 'pictorial Epworth Sleepiness Scale (pESS) score', 'General health scores', 'Anxiety/Antisocial', 'verbal', 'nonverbal intelligence scores', 'behaviour scores', 'sleepiness and behavioural/emotional outcomes', 'Depressive']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0442754', 'cui_str': 'Distance vision 6/24'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",19.0,0.111053,Improvement was noted in verbal ( p  = 0.001) and nonverbal intelligence scores ( p  = 0.011).,"[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hill', 'Affiliation': 'Sleep Research Unit, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Fairley', 'Affiliation': 'Sleep Research Unit, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Williams', 'Affiliation': 'Centre for Population Health Sciences, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}, {'ForeName': 'Goffredina', 'Initials': 'G', 'LastName': 'Spanò', 'Affiliation': 'Down Syndrome Research Group, Department of Psychology, University of Arizona, Tucson, AZ 85721, USA.'}, {'ForeName': 'Sally-Ann', 'Initials': 'SA', 'LastName': 'Cooper', 'Affiliation': 'Mental Health and Wellbeing Research Group, Institute of Health and Wellbeing, University of Glasgow, Glasgow G12 0XH, UK.'}, {'ForeName': 'Renata L', 'Initials': 'RL', 'LastName': 'Riha', 'Affiliation': 'Sleep Research Unit, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}]",Brain sciences,['10.3390/brainsci10110844']
2110,33198538,National inter-rater agreement of standardised simulated-patient-based assessments.,"PURPOSE


The forthcoming UK Medical Licensing Assessment will require all medical schools in the UK to ensure that their students pass an appropriately designed Clinical and Professional Skills Assessment (CPSA) prior to graduation and registration with a licence to practice medicine. The requirements for the CPSA will be set by the General Medical Council, but individual medical schools will be responsible for implementing their own assessments. It is therefore important that assessors from different medical schools across the UK agree on what standard of performance constitutes a fail, pass or good grade.
METHODS


We used an experimental video-based, single-blinded, randomised, internet-based design. We created videos of simulated student performances of a clinical examination at four scripted standards: clear fail (CF), borderline (BD), clear pass (CPX) and good (GD). Assessors from ten regions across the UK were randomly assigned to watch five videos in 12 different combinations and asked to give competence domain scores and an overall global grade for each simulated candidate. The inter-rater agreement as measured by the intraclass correlation coefficient (ICC) based on a two-way random-effects model for absolute agreement was calculated for the total domain scores.
RESULTS


120 assessors enrolled in the study, with 98 eligible for analysis. The ICC was 0.93 (95% CI 0.81-0.99). The mean percentage agreement with the scripted global grade was 74.4% (range 40.8-96.9%).
CONCLUSIONS


The inter-rater agreement amongst assessors across the UK when rating simulated candidates performing at scripted levels is excellent. The level of agreement for the overall global performance level for simulated candidates is also high. These findings suggest that assessors from across the UK viewing the same simulated performances show high levels of agreement of the standards expected of students at a 'clear fail,' 'borderline,' 'clear pass' and 'good' level.",2020,The inter-rater agreement amongst assessors across the UK when rating simulated candidates performing at scripted levels is excellent.,"['Assessors from ten regions across the UK', '120 assessors enrolled in the study, with 98 eligible for analysis']",[],[],"[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],[],120.0,0.0278514,The inter-rater agreement amongst assessors across the UK when rating simulated candidates performing at scripted levels is excellent.,"[{'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Sam', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Reid', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Viral', 'Initials': 'V', 'LastName': 'Thakerar', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gurnell', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Westacott', 'Affiliation': 'Birmingham Medical School, University of Birmingham, Birmingham, Edgbaston, UK.'}, {'ForeName': 'Malcolm W R', 'Initials': 'MWR', 'LastName': 'Reed', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Celia A', 'Initials': 'CA', 'LastName': 'Brown', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}]",Medical teacher,['10.1080/0142159X.2020.1845909']
2111,33198568,"Gait Disturbance Improvement and Cerebral Cortex Rearrangement by Acupuncture in Parkinson's Disease: A Pilot Assessor-Blinded, Randomized, Controlled, Parallel-Group Trial.","BACKGROUND


Parkinson's disease (PD) leads to impaired mobility and limited independence.
OBJECTIVE


We investigated the effects of acupuncture on gait disturbance and analyzed hemodynamic changes caused by acupuncture in the cerebral cortex of patients with PD.
METHODS


Participants (n = 26) with gait disturbance due to PD were randomly assigned to the intervention (acupuncture twice a week for 4 weeks + conventional therapy) or control (conventional therapy) groups. We analyzed gait parameters using the GAITRite system and hemodynamic responses in the cerebral cortices using functional near-infrared spectroscopy, Unified Parkinson's Disease Rating Scale (UPDRS) scores, neurotransmitter levels, as well as the immediate effects of acupuncture in patients with PD.
RESULTS


The participants tended to walk with hypometric gait (high cadence, short steps) overground. After acupuncture treatment, those in the intervention group showed a significant reduction in cadence and the UPDRS scores involving ""walking and balance"" compared with those in the control group ( P  = .004 and  P  = .020, respectively); the stride, swing, and single support times were significantly increased ( P  = .006,  P  = .001, and  P  = .001, respectively). Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas. The oxyhemoglobin levels in the prefrontal cortex and swing time revealed significant positive correlations.
CONCLUSIONS


Our findings indicated that acupuncture tended to improve hypometric gait and rearranged activation of the cerebral cortex. Thus, acupuncture may be a useful complementary treatment for gait disturbance, including hypometric gait, in patients with PD.  Trial Registration Number . Clinical Research Information Service (KCT0002603), https://cris.nih.go.kr/cris/index.jsp.",2020,Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas.,"[""Parkinson's Disease"", 'patients with PD.\nMETHODS\n\n\nParticipants (n = 26) with gait disturbance due to PD', 'patients with PD']","['Acupuncture', 'intervention (acupuncture twice a week for 4 weeks + conventional therapy) or control (conventional therapy', 'acupuncture']","['gait disturbance and analyzed hemodynamic changes', 'stride, swing, and single support times', 'Gait Disturbance Improvement and Cerebral Cortex Rearrangement', ""Parkinson's Disease Rating Scale (UPDRS) scores, neurotransmitter levels"", 'oxyhemoglobin levels', 'cadence and the UPDRS scores involving ""walking and balance', 'hypometric gait and rearranged activation of the cerebral cortex', 'Oxyhemoglobin levels']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",26.0,0.0498053,Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas.,"[{'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Sangsoo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Jinung', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Convergence Research Center for Wellness, Digist R4-814, Dalseong-Gun, Daegu, Republic of Korea.'}, {'ForeName': 'Jong-Duk', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'College of Health & Medical Science, Graduate School, Daejeon City, Republic of Korea.'}, {'ForeName': 'In Chan', 'Initials': 'IC', 'LastName': 'Seol', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Gunhyuk', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Korea Institute of Oriental Medicine, Naju-si, Jeollanam-do, Republic of Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Korea University, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'College of Health & Medical Science, Graduate School, Daejeon City, Republic of Korea.'}, {'ForeName': 'Weechang', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Daejeon University, Dong-gu, Daejeon City, Republic of Korea.'}, {'ForeName': 'Eun-Sun', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji-Yun', 'Initials': 'JY', 'LastName': 'Cha', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Chan-Young', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Siyeon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'In Chul', 'Initials': 'IC', 'LastName': 'Jung', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Horyong', 'Initials': 'H', 'LastName': 'Yoo', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320969942']
2112,33198595,Developing Cognitive Bias Modification Scenarios for Women with Sexual Interest Arousal Disorder and Comparing Effectiveness with Mindfulness Therapy.,"The aim of the present study was to develop and validate the scenarios of cognitive bias modification of interpretation (CBM-I) in women with sexual interest arousal disorder (SIAD) and comparing its effectiveness with mindfulness therapy in Iran. This study was performed by mixed method in two phases. In the first phase of the study, CBM treatment scenarios were developed. In the second phase, 45 women with SIAD were selected and randomly divided into three groups (two experimental groups and one control group). In the qualitative phase of the research on the evaluation of the designed scenarios, 80 scenarios remained among the 100 scenarios by meeting the content validity criteria, fidelity, acceptance, and satisfaction with the treatment. Both experimental treatments exceeded the no treatment control but that mindfulness was more effective than CBM-I as measured by the Female Sexual Function Index Questionnaire ( p  < 0.001). According to the findings, the use of CBM-I to replace positive interpretations with negative interpretations of cognitive bias in SIAD has a clinical application. Therefore, CBM-I can be used as practical treatment along with other treatments to reduce the symptoms of sexual dysfunction.",2020,Both experimental treatments exceeded the no treatment control but that mindfulness was more effective than CBM-I as measured by the Female Sexual Function Index Questionnaire ( p  < 0.001).,"['women with sexual interest arousal disorder (SIAD', 'Iran', 'Women with Sexual Interest Arousal Disorder', '45 women with SIAD']",['interpretation (CBM-I'],"['Female Sexual Function Index Questionnaire', 'content validity criteria, fidelity, acceptance, and satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",45.0,0.0147829,Both experimental treatments exceeded the no treatment control but that mindfulness was more effective than CBM-I as measured by the Female Sexual Function Index Questionnaire ( p  < 0.001).,"[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Halvaiepour', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Yazdkhasti', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Oreyzi', 'Affiliation': 'Department of Psychology, Faculty of Education and Psychology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Nosratabadi', 'Affiliation': 'Social Determinants of Health Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of sex & marital therapy,['10.1080/0092623X.2020.1842572']
2113,33198608,Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin.,"BACKGROUND AND PURPOSE


Among patients with a transient ischemic attack or minor ischemic strokes, those with ipsilateral atherosclerotic stenosis of cervicocranial vasculature have the highest risk of recurrent vascular events.
METHODS


In the double-blind THALES (The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death) trial, we randomized patients with a noncardioembolic, nonsevere ischemic stroke, or high-risk transient ischemic attack to ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2-30) or placebo added to aspirin (300-325 mg on day 1 followed by 75-100 mg daily for days 2-30) within 24 hours of symptom onset. The present paper reports a prespecified analysis in patients with and without ipsilateral, potentially causal atherosclerotic stenosis ≥30% of cervicocranial vasculature. The primary end point was time to the occurrence of stroke or death within 30 days.
RESULTS


Of 11 016 randomized patients, 2351 (21.3%) patients had an ipsilateral atherosclerotic stenosis. After 30 days, a primary end point occurred in 92/1136 (8.1%) patients with ipsilateral stenosis randomized to ticagrelor and in 132/1215 (10.9%) randomized to placebo (hazard ratio 0.73 [95% CI, 0.56-0.96],  P =0.023) resulting in a number needed to treat of 34 (95% CI, 19-171). In patients without ipsilateral stenosis, the corresponding event rate was 211/4387 (4.8%) and 230/4278 (5.4%), respectively (hazard ratio, 0.89 [95% CI, 0.74-1.08];  P =0.23,  P interaction =0.245). Severe bleeding occurred in 4 (0.4%) and 3 (0.2%) patients with ipsilateral atherosclerotic stenosis on ticagrelor and on placebo, respectively ( P =NS), and in 24 (0.5%) and 4 (0.1%), respectively, in 8665 patients without ipsilateral stenosis (hazard ratio=5.87 [95% CI, 2.04-16.9],  P =0.001).
CONCLUSIONS


In this exploratory analysis comparing ticagrelor added to aspirin to aspirin alone, we found no treatment by ipsilateral atherosclerosis stenosis subgroup interaction but did identify a higher absolute risk and a greater absolute risk reduction of stroke or death at 30 days in patients with ipsilateral atherosclerosis stenosis than in those without. In this easily identified population, ticagrelor added to aspirin provided a clinically meaningful benefit with a number needed to treat of 34 (95% CI, 19-171).
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT03354429.",2020,"Severe bleeding occurred in 4 (0.4%) and 3 (0.2%) patients with ipsilateral atherosclerotic stenosis on ticagrelor and on placebo, respectively ( P =NS), and in 24 (0.5%) and 4 (0.1%), respectively, in 8665 patients without ipsilateral stenosis (hazard ratio=5.87 [95% CI, 2.04-16.9],  P =0.001).
","['patients with and without ipsilateral, potentially causal atherosclerotic stenosis ≥30% of cervicocranial vasculature', 'Of 11 016 randomized patients, 2351 (21.3%) patients had an ipsilateral atherosclerotic stenosis', 'patients with a transient ischemic attack or minor ischemic strokes', 'patients with a noncardioembolic, nonsevere ischemic stroke, or high-risk transient ischemic attack to']","['Ticagrelor', 'Ticagrelor and ASA', 'Aspirin', 'placebo', 'ticagrelor', 'aspirin', 'placebo added to aspirin']","['corresponding event rate', 'time to the occurrence of stroke or death', 'ipsilateral atherosclerotic stenosis', 'Severe bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",11016.0,0.435234,"Severe bleeding occurred in 4 (0.4%) and 3 (0.2%) patients with ipsilateral atherosclerotic stenosis on ticagrelor and on placebo, respectively ( P =NS), and in 24 (0.5%) and 4 (0.1%), respectively, in 8665 patients without ipsilateral stenosis (hazard ratio=5.87 [95% CI, 2.04-16.9],  P =0.001).
","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Center, Bichat University Hospital, University of Paris, France (P.A.).'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Denison', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden (H.D., A.H., M.K., P.L.).'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Evans', 'Affiliation': 'Biostatistics Center, George Washington University, Washington (S.R.E.).'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden (H.D., A.H., M.K., P.L.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden (S.J.).'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knutsson', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden (H.D., A.H., M.K., P.L.).'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ladenvall', 'Affiliation': 'AstraZeneca, Biopharmaceuticals R&D, Gothenburg, Sweden (H.D., A.H., M.K., P.L.).'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain (C.A.M.).""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tiantan Hospital, Beijing, China (Y.W.).'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas, Austin (S.C.J.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.032239']
2114,33201119,Two Year Outcomes of Prehabilitation Among Obese Patients with Ventral Hernias: A Randomized Controlled Trial (NCT02365194).,"OBJECTIVE


To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)?
SUMMARY BACKGROUND DATA


Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR.
METHODS


This is the 2-year follow-up of a blinded randomized controlled trial from 2015-2017 at a safety-net academic institution. Obese patients(BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2-years. Complications included recurrence, re-operation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years.
RESULTS


Of the 118 randomized patients, 108(91.5%) completed a median(range) follow-up of 27.3(6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ± 2.6 vs 37.0 ± 2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, p = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, p = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% versus 66.1%, p = 0.424, 1.14, 0.88-1.47).
CONCLUSION


There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR.
CLINICAL TRIAL REGISTRATION


This trial was registered with clinicaltrials.gov (NCT02365194)Conflict of Interest and Source of Funding: This work was supported by grants awarded to Dr. Liang from the Center for Clinical and Translational Sciences [grant number UL1 TR000370] and the National Center for Advancing Translational Sciences [grant number KL2 TR000370]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research or the National Institute of Health. The remaining authors have nothing to disclose.
FUNDING


Grants from the Center for Clinical and Translational Sciences [UL1 TR000370] and the National Center for Advancing Translational Sciences [KL2 TR000370].",2020,There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care.,"['obese patients undergoing elective VHR', 'obese patients seeking ventral hernia repair (VHR', 'obese patients with VHR', 'obese patients seeking VHR', 'Obese patients(BMI 30-40) seeking VHR', '2015-2017 at a safety-net academic institution', 'Obese Patients with Ventral Hernias']","['preoperative nutritional counseling and exercise (prehabilitation', 'Prehabilitation', 'prehabilitation versus standard counseling', 'Elective VHR']","['emergency surgery', 'percentage of hernia-free and complication-free patients at 2-years', 'recurrence, re-operation, and mesh complications', 'Baseline BMI (mean±SD', 'major complications', 'percentage of hernia-free and complication']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",118.0,0.215257,There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care.,"[{'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Naila H', 'Initials': 'NH', 'LastName': 'Dhanani', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lyons', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Holihan', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Deepa V', 'Initials': 'DV', 'LastName': 'Cherla', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Berger', 'Affiliation': 'Surgery Department, Baylor Medical School (Houston, TX).'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Surgery Department, McGovern Medical School at the University of Texas Health Science Center Houston, (Houston, TX).'}]",Annals of surgery,['10.1097/SLA.0000000000004486']
2115,33201120,Surgical Complications in a Multicenter Randomized Trial Comparing Preoperative Chemoradiotherapy and Immediate Surgery in Patients With Resectable and Borderline Resectable Pancreatic Cancer (PREOPANC Trial).,"OBJECTIVES


To investigate the effect of preoperative chemoradiotherapy on surgical complications in patients after pancreatic resection for (borderline-)resectable pancreatic cancer.
SUMMARY OF BACKGROUND DATA


Preoperative chemoradiotherapy is increasingly used in patients with (borderline-)resectable pancreatic cancer. Concerns have been raised about the potential harmful effect of any preoperative therapy on the surgical complication rate after pancreatic resection.
METHODS


An observational analysis was performed within the multicenter randomized controlled PREOPANC trial (April 2013-July 2017). The trial randomly assigned (1:1) patients to preoperative chemoradiotherapy followed by surgery and the remaining adjuvant chemotherapy or to immediate surgery, followed by adjuvant chemotherapy. The main analysis consisted of a per-protocol approach. The endpoints of the present analyses were the rate of postoperative complications.
RESULTS


This study included 246 patients from 16 centers, of whom 66 patients underwent resection after preoperative therapy and 98 patients after immediate surgery. No differences were found regarding major complications (37.9% vs 30.6%, P = 0.400), postpancreatectomy hemorrhage (9.1% vs 5.1%, P = 0.352), delayed gastric emptying (21.2% vs 22.4%, P = 0.930), bile leakage (4.5% vs 3.1%, P = 0.686), intra-abdominal infections (12.1% vs 10.2%, P = 0.800), and mortality (3.0% vs 4.1%, P = 1.000). There was a significant lower incidence of postoperative pancreatic fistula in patients who received preoperative chemoradiotherapy (0% vs 9.2%, P = 0.011).
CONCLUSIONS


Preoperative chemoradiotherapy did not increase the incidence of surgical complications or mortality and reduced the rate of postoperative pancreatic fistula after resection in patients with (borderline-)resectable pancreatic cancer.",2020,"No differences were found regarding major complications (37.9% vs 30.6%, P = 0.400), postpancreatectomy hemorrhage (9.1% vs 5.1%, P = 0.352), delayed gastric emptying (21.2% vs 22.4%, P = 0.930), bile leakage (4.5% vs 3.1%, P = 0.686), intra-abdominal infections (12.1% vs 10.2%, P = 0.800), and mortality (3.0% vs 4.1%, P = 1.000).","['patients with (borderline-)resectable pancreatic cancer', 'patients after pancreatic resection for (borderline-)resectable pancreatic cancer', '246 patients from 16 centers, of whom 66 patients underwent resection after preoperative therapy and 98 patients after immediate surgery', 'Patients With Resectable and Borderline Resectable Pancreatic Cancer (PREOPANC Trial']","['preoperative chemoradiotherapy', 'Preoperative Chemoradiotherapy and Immediate Surgery', 'Preoperative chemoradiotherapy', 'preoperative chemoradiotherapy followed by surgery and the remaining adjuvant chemotherapy or to immediate surgery, followed by adjuvant chemotherapy']","['intra-abdominal infections', 'rate of postoperative complications', 'incidence of surgical complications or mortality', 'rate of postoperative pancreatic fistula', 'postpancreatectomy hemorrhage', 'postoperative pancreatic fistula', 'surgical complication rate', 'major complications', 'delayed gastric emptying', 'bile leakage', 'mortality', 'surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854778', 'cui_str': 'Pancreatic carcinoma resectable'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C1112209', 'cui_str': 'Infectious disease of abdomen'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}]",246.0,0.0852009,"No differences were found regarding major complications (37.9% vs 30.6%, P = 0.400), postpancreatectomy hemorrhage (9.1% vs 5.1%, P = 0.352), delayed gastric emptying (21.2% vs 22.4%, P = 0.930), bile leakage (4.5% vs 3.1%, P = 0.686), intra-abdominal infections (12.1% vs 10.2%, P = 0.800), and mortality (3.0% vs 4.1%, P = 1.000).","[{'ForeName': 'Jelle C', 'Initials': 'JC', 'LastName': 'van Dongen', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Suker', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Versteijne', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bert A', 'Initials': 'BA', 'LastName': 'Bonsing', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Sven D', 'Initials': 'JSD', 'LastName': 'Mieog', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'de Vos-Geelen', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, GROW School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'van der Harst', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Gijs A', 'Initials': 'GA', 'LastName': 'Patijn', 'Affiliation': 'Department of Surgery, Isala Oncology Center, Zwolle, the Netherlands.'}, {'ForeName': 'Ignace H', 'Initials': 'IH', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Festen', 'Affiliation': 'Department of Surgery, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Ten Tije', 'Affiliation': 'Department of Medical Oncology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'van Tienhoven', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Groot Koerkamp', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Casper H J', 'Initials': 'CHJ', 'LastName': 'van Eijck', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004313']
2116,33201130,Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial.,"OBJECTIVE


To assess the efficacy of adjunctive IPC to standard prophylaxis of postoperative VTE in patients at extremely high-risk.
SUMMARY OF BACKGROUND DATA


The standard prophylaxis for postoperative VTE is insufficient in extremely high-risk patients. It is unclear whether an adjunctive use of IPC would result in a lower incidence of postoperative venous thrombosis.
METHODS


We randomly assigned patients who underwent major surgery and had a Caprini score of ≥11 to receive either IPC in addition to standard prophylaxis with anti-embolic stockings (pressure of 18-21 mm Hg at the ankle) and low-molecular-weight heparin (IPC group) or standard prophylaxis alone (control group). The primary outcome was an asymptomatic venous thrombosis of the lower limbs, as detected by duplex ultrasound scan performed before inclusion and every 3-5 days after surgery.
RESULTS


A total of 407 patients underwent randomization, of which 204 were assigned to the IPC group and 203 to the control group. The primary outcome occurred in 1 (0.5%) patient in the IPC group and 34 (16.7%) patients in the control group [relative risk, 0.03, 95% confidential interval (CI): 0.01-0.21]. Pulmonary embolism occurred in none of the 204 patients in the IPC group and in 5 (2.5%) patients in the control group (relative risk, 0.09; 95% CI, 0.01-1.63), and postoperative death occurred in 6 (2.9%) patients in the IPC group and 10 (4.9%) in the control group (relative risk, 0.50; 95% CI, 0.50-1.60).
CONCLUSIONS


Among patients with a Caprini score of ≥11 who received standard prophylaxis for VTE, adjunctive IPC resulted in a significantly lower incidence of asymptomatic venous thrombosis.",2020,"Pulmonary embolism occurred in none of the 204 patients in the IPC group and in 5 (2.5%) patients in the control group (relative risk, 0.09; 95% CI, 0.01-1.63), and postoperative death occurred in 6 (2.9%) patients in the IPC group and 10 (4.9%) in the control group (relative risk, 0.50; 95% CI, 0.50-1.60).
","['patients at extremely high-risk', 'A total of 407 patients underwent randomization, of which 204 were assigned to the IPC group and 203 to the control group', 'Extremely High-risk Patients (IPC SUPER', 'We randomly assigned patients who underwent major surgery and had a Caprini score of ≥11 to receive either', 'patients with a Caprini score of ≥11 who received']","['Intermittent Pneumatic Compression', 'adjunctive IPC', 'standard prophylaxis for VTE, adjunctive IPC', 'IPC', 'IPC in addition to standard prophylaxis with anti-embolic stockings (pressure of 18-21\u200amm Hg at the ankle) and low-molecular-weight heparin (IPC group) or standard prophylaxis alone (control group']","['Pulmonary embolism', 'asymptomatic venous thrombosis', 'asymptomatic venous thrombosis of the lower limbs', 'postoperative death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0277599', 'cui_str': 'Postoperative death'}]",407.0,0.212382,"Pulmonary embolism occurred in none of the 204 patients in the IPC group and in 5 (2.5%) patients in the control group (relative risk, 0.09; 95% CI, 0.01-1.63), and postoperative death occurred in 6 (2.9%) patients in the IPC group and 10 (4.9%) in the control group (relative risk, 0.50; 95% CI, 0.50-1.60).
","[{'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Lobastov', 'Affiliation': 'Department of General Surgery and Radiology, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Sautina', 'Affiliation': 'Department of General Surgery and Radiology, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Eleanora', 'Initials': 'E', 'LastName': 'Alencheva', 'Affiliation': 'Department of Surgery and Endoscopy, Central State Medical Academy of the Presidents Administration of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Astanda', 'Initials': 'A', 'LastName': 'Bargandzhiya', 'Affiliation': 'Department of General Surgery and Radiology, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Schastlivtsev', 'Affiliation': 'Department of General Surgery and Radiology, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Barinov', 'Affiliation': 'Department of Surgery and Endoscopy, Central State Medical Academy of the Presidents Administration of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Laberko', 'Affiliation': 'Department of General Surgery and Radiology, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Grigoriy', 'Initials': 'G', 'LastName': 'Rodoman', 'Affiliation': 'Department of General Surgery and Radiology, Pirogov Russian National Research Medical University, Moscow, Russian Federation.'}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Boyarintsev', 'Affiliation': 'Department of Surgery and Endoscopy, Central State Medical Academy of the Presidents Administration of the Russian Federation, Moscow, Russian Federation.'}]",Annals of surgery,['10.1097/SLA.0000000000004556']
2117,33201154,"Neoprene Knee Sleeves of Varying Tightness Augment Barbell Squat One Repetition Maximum Performance Without Improving Other Indices of Muscular Strength, Power, or Endurance.","Machek, SB, Cardaci, TD, Wilburn, DT, Cholewinski, MC, Latt, SL, Harris, DR, and Willoughby, DS. Neoprene knee sleeves of varying tightness augment barbell squat one repetition maximum performance without improving other indices of muscular strength, power, or endurance. J Strength Cond Res XX(X): 000-000, 2020-Neoprene knee sleeves are commonly used by powerlifters and recreational users but are heavily under-researched. Furthermore, no data exist on whether knee sleeves of varying compressive tightness impact muscular performance similar to commonly used knee wraps, which are both generally effective and more so when increasingly constrictive. Fifteen resistance trained, knee sleeve naive, recreational weightlifting men (22.1 ± 4.1 years; 177.5 ± 5.9 cm; 87.8 ± 7.8 kg) visited the laboratory on 3 separate occasions one week apart, assigned in a randomized, crossover, and counterbalanced fashion to either a minimally supportive control sleeve (CS) condition, a manufacturer-recommended sizing neoprene knee sleeve (""normal"" sleeve; NS), or a one size smaller (than NS) neoprene knee sleeve (tighter sleeve [TS]). On each visit, subjects sequentially completed vertical jump (countermovement and squat jumps for both peak and mean power), one repetition maximum (1RM) barbell squat, and GymAware assessments (peak power, peak velocity, and dip) at 90% (reported) and 100% (tested) 1RM as well as one-leg extension (1RM, repetitions to failure, and total volume load at 75% 1RM) tests. All data were analyzed using one-way repeated measures analysis of variance at p < 0.05. Analysis revealed a significant condition effect on barbell squat 1RM (p = 0.003; η = 0.339), whereby both NS (p = 0.044; 166 ± 24 kg) and TS (p = 0.019; 166 ± 21 kg) outperformed CS (161 ± 22 kg), with no difference between neoprene sleeves. Conversely, no other tested parameters differed between knee sleeve conditions (p ≥ 0.05). The present results demonstrate that neoprene knee sleeves may function independent of tightness, relative to recommended sizing and ultimately unlike knee wraps. Furthermore, the singular benefits observed on barbell squat maximal strength potentially suggests an exercise-specific benefit yet to be fully elucidated.",2020,"Analysis revealed a significant condition effect on barbell squat 1RM (p = 0.003; η = 0.339), whereby both NS (p = 0.044; 166 ± 24 kg) and TS (p = 0.019; 166 ± 21 kg) outperformed CS (161 ± 22 kg), with no difference between neoprene sleeves.","['Fifteen resistance trained, knee sleeve naive, recreational weightlifting men (22.1 ± 4.1 years; 177.5 ± 5.9 cm; 87.8 ± 7.8 kg) visited the laboratory on 3 separate occasions one week apart']","['J Strength Cond Res XX(X', 'Varying Tightness Augment Barbell Squat One Repetition Maximum Performance', 'minimally supportive control sleeve (CS) condition, a manufacturer-recommended sizing neoprene knee sleeve (""normal"" sleeve; NS), or a one size smaller (than NS) neoprene knee sleeve (tighter sleeve [TS']","['Machek, SB, Cardaci, TD, Wilburn, DT, Cholewinski, MC, Latt, SL, Harris, DR, and Willoughby, DS', 'Muscular Strength, Power, or Endurance', 'repetition maximum (1RM) barbell squat, and GymAware assessments (peak power, peak velocity, and dip', 'barbell squat 1RM', 'muscular strength, power, or endurance']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027673', 'cui_str': 'Neoprene'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}]",15.0,0.0488826,"Analysis revealed a significant condition effect on barbell squat 1RM (p = 0.003; η = 0.339), whereby both NS (p = 0.044; 166 ± 24 kg) and TS (p = 0.019; 166 ± 21 kg) outperformed CS (161 ± 22 kg), with no difference between neoprene sleeves.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Mitchell C', 'Initials': 'MC', 'LastName': 'Cholewinski', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Baylor University, Waco, Texas.'}, {'ForeName': 'Scarlett Lin', 'Initials': 'SL', 'LastName': 'Latt', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Dillon R', 'Initials': 'DR', 'LastName': 'Harris', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003869']
2118,33201144,Effectiveness of Multilayered Polyurethane Foam Dressings to Prevent Hospital-Acquired Sacral Pressure Injuries in Patients With Hip Fracture: A Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to determine the effectiveness of a multilayered polyurethane foam dressing applied within 24 hours of hospital admission compared with standard preventive pressure injury (PI) care in reducing sacral PI occurrence in older patients with hip fractures.
DESIGN


Open-label, parallel-group, 2-arm, superiority trial.
SUBJECTS AND SETTING


The sample comprised older patients aged 69 to 97 years admitted to a 1500-bed university hospital in Bologna, Italy, for hip fracture surgery.
METHODS


Patients were randomly allocated to an intervention or control group. Both groups received standard evidence-based PI preventive care in accordance with National Pressure Ulcer Advisory Panel guidelines. In addition, patients in the intervention group received a single 12.9 × 12.9-cm multilayered polyurethane foam dressing shaped for the sacrum area applied within 24 hours of hospital admission. Bivariate analysis on primary and secondary outcomes and baseline characteristics was performed to compare group differences, and a survival analysis was used to determine the difference in PI incidence rates per group.
RESULTS


Sixty-eight patients completed the trial; 34 patients were allocated to the intervention group and 34 patients to the control group. A trend toward significance was observed for sacral PI occurrence in the intervention group (intervention: 20.6%; control: 2.9%; P = .054). The foam dressing allowed significantly longer time (days) to PI occurrence (intervention: 5.9 ± 1.60; control: 2.7 ± 0.96; P = .003).
CONCLUSIONS


These findings suggest that multilayered polyurethane foam dressings are not superior to the standard preventive PI care alone and should be used with caution, especially when multiple dressing changes may occur. Further exploration of the role of multilayered polyurethane foam dressings in preventing PI development is warranted.",2020,"The foam dressing allowed significantly longer time (days) to PI occurrence (intervention: 5.9 ± 1.60; control: 2.7 ± 0.96; P = .003).
","['older patients aged 69 to 97 years admitted to a 1500-bed university hospital in Bologna, Italy, for hip fracture surgery', 'Patients', 'older patients with hip fractures', 'With Hip Fracture', 'Sixty-eight patients completed the trial; 34 patients']","['Multilayered Polyurethane Foam Dressings', 'standard evidence-based PI preventive care', 'multilayered polyurethane foam dressing', 'standard preventive pressure injury (PI) care']","['PI incidence rates', 'sacral PI occurrence', 'longer time (days) to PI occurrence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0460852', 'cui_str': 'Polyurethane foam dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",34.0,0.0574927,"The foam dressing allowed significantly longer time (days) to PI occurrence (intervention: 5.9 ± 1.60; control: 2.7 ± 0.96; P = .003).
","[{'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Gazineo', 'Affiliation': 'Domenica Gazineo, MSN, Evidence-Based Nursing Centre, Azienda Ospedaliero-Universitaria, Bologna, Italy. Matteo Chiarabelli, MSN, Cardio-Thoracic Vascular Department, Azienda Ospedaliero-Universitaria, Bologna, Italy. Rosanna Cirone, RN, Azienda Ospedaliero-Universitaria, Bologna, Italy. Paolo Chiari, MSN, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. Elisa Ambrosi, PhD, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Chiarabelli', 'Affiliation': ''}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Cirone', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Chiari', 'Affiliation': ''}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ambrosi', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000715']
2119,33201202,Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial.,"Importance


Clinical guidelines for the early management of acute heart failure in the emergency department (ED) setting are based on only moderate levels of evidence, with subsequent low adherence to these guidelines.
Objective


To test the effect of an early guideline-recommended care bundle on short-term prognosis in older patients with acute heart failure in the ED.
Design, Setting, and Participants


Stepped-wedge cluster randomized trial in 15 EDs in France of 503 patients 75 years and older with a diagnosis of acute heart failure in the ED from December 2018 to September 2019 and followed up for 30 days until October 2019.
Interventions


A care bundle that included early intravenous nitrate boluses; management of precipitating factors, such as acute coronary syndrome, infection, or atrial fibrillation; and moderate dose of intravenous diuretics (n = 200). In the control group, patient care was left to the discretion of the treating emergency physician (n = 303). Each center was randomized to the order in which they switched to the ""intervention period."" After the initial 4-week control period for all centers, 1 center entered in the intervention period every 2 weeks.
Main Outcomes and Measures


The primary end point was the number of days alive and out of hospital at 30 days. Secondary outcomes included 30-day all-cause mortality, 30-day cardiovascular mortality, unscheduled readmission, length of hospital stay, and kidney impairment.
Results


Among 503 patients who were randomized (median age, 87 years; 298 [59%] women), 502 were analyzed. In the intervention group, patients received a median (interquartile range) of 27.0 (9-54) mg of intravenous nitrates in the first 4 hours vs 4.0 (2.0-6.0) mg in the control group (adjusted difference, 23.8 [95% CI, 13.5-34.1]). There was a significantly higher percentage of patients in the intervention group treated for their precipitating factors than in the control group (58.8% vs 31.9%; adjusted difference, 31.1% [95% CI, 14.3%-47.9%]). There was no statistically significant difference in the primary end point of the number of days alive and out of hospital at 30 days (median [interquartile range], 19 [0- 24] d in both groups; adjusted difference, -1.9 [95% CI, -6.6 to 2.8]; adjusted ratio, 0.88 [95% CI, 0.64-1.21]). At 30 days, there was no significant difference between the intervention and control groups in mortality (8.0% vs 9.7%; adjusted difference, 4.1% [95% CI, -17.2% to 25.3%]), cardiovascular mortality (5.0% vs 7.4%; adjusted difference, 2.1% [95% CI, -15.5% to 19.8%]), unscheduled readmission (14.3% vs 15.7%; adjusted difference, -1.3% [95% CI, -26.3% to 23.7%]), median length of hospital stay (8 d in both groups; adjusted difference, 2.5 [95% CI, -0.9 to 5.8]), and kidney impairment (1% in both groups).
Conclusions and Relevance


Among older patients with acute heart failure, use of a guideline-based comprehensive care bundle in the ED compared with usual care did not result in a statistically significant difference in the number of days alive and out of the hospital at 30 days. Further research is needed to identify effective treatments for acute heart failure in older patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT03683212.",2020,"There was a significantly higher percentage of patients in the intervention group treated for their precipitating factors than in the control group (58.8% vs 31.9%; adjusted difference, 31.1% [95% CI, 14.3%-47.9%]).","['Elderly Patients With Acute Heart Failure', '503 patients who were randomized (median age, 87 years; 298 [59%] women), 502 were analyzed', 'older patients', 'older patients with acute heart failure', 'Participants\n\n\nStepped-wedge cluster randomized trial in 15 EDs in France of 503 patients 75 years and older with a diagnosis of acute heart failure in the ED from December 2018 to September 2019 and followed up for 30 days until October 2019', 'older patients with acute heart failure in the ED']","['Emergency Department Care Bundle', 'early guideline-recommended care bundle', 'intravenous diuretics']","['kidney impairment', '30-day all-cause mortality, 30-day cardiovascular mortality, unscheduled readmission, length of hospital stay, and kidney impairment', 'cardiovascular mortality', 'median length of hospital stay', 'number of days alive and out of hospital at 30 days', 'unscheduled readmission', 'number of days alive and out of hospital', '30-Day Hospital Discharge and Survival', 'mortality']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}]","[{'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",15.0,0.18787,"There was a significantly higher percentage of patients in the intervention group treated for their precipitating factors than in the control group (58.8% vs 31.9%; adjusted difference, 31.1% [95% CI, 14.3%-47.9%]).","[{'ForeName': 'Yonathan', 'Initials': 'Y', 'LastName': 'Freund', 'Affiliation': 'Sorbonne Université, Improving Emergency Care FHU, Paris, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Cachanado', 'Affiliation': 'Clinical Research Platform (URC-CRC-CRB), Hôpital Saint-Antoine, APHP, Paris, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Delannoy', 'Affiliation': 'Emergency Department, Hôpital Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris (APHP), Paris, France.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Laribi', 'Affiliation': 'Emergency Department, Hôpital Bretonneau, Tours, France.'}, {'ForeName': 'Youri', 'Initials': 'Y', 'LastName': 'Yordanov', 'Affiliation': 'Sorbonne Université, Improving Emergency Care FHU, Paris, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gorlicki', 'Affiliation': 'Emergency Department, Hôpital Avicenne, APHP, Bobigny, France.'}, {'ForeName': 'Tahar', 'Initials': 'T', 'LastName': 'Chouihed', 'Affiliation': 'Emergency Department, Hôpital CHRU Nancy, INSERM U1116, Université de Lorraine, Vandoeuvre les Nancy, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Féral-Pierssens', 'Affiliation': 'Emergency Department, Hôpital Européen Georges Pompidou, APHP, Paris, France.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Truchot', 'Affiliation': 'Emergency Department, Hôpital Lariboisière, APHP, Paris, France.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Desmettre', 'Affiliation': 'Emergency Department, CHRU Besançon, Besançon, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Occelli', 'Affiliation': 'Emergency Department, CHU Nice, Nice, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bobbia', 'Affiliation': 'Emergency Department, CHU Nîmes, Nîmes, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Khellaf', 'Affiliation': 'Emergency Department, Hôpital Henri Mondor, APHP, Université Paris Est - INSERM U955, Créteil, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ganansia', 'Affiliation': 'Emergency Department, Hôpital Paris Saint Joseph, Groupe Hospitalier Paris Saint Joseph.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Bokobza', 'Affiliation': 'Emergency Department, Hôpital Cochin, APHP, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Balen', 'Affiliation': 'Emergency Department, Centre hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Beaune', 'Affiliation': 'Emergency Department, Hôpital Ambroise-Paré, APHP, Boulogne, Inserm U1144, Université de Paris, France.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Bloom', 'Affiliation': 'Emergency Department, Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Sorbonne Université, Improving Emergency Care FHU, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'Department of Anesthesia, Burn and Critical Care, Hôpitaux Universitaires Saint Louis Lariboisière, FHU PROMICE INI-CRCT, AP-HP, France.'}]",JAMA,['10.1001/jama.2020.19378']
2120,33201347,Serum 4β-hydroxycholesterol increases during fluconazole treatment.,"PURPOSE


The antifungal drugs ketoconazole and itraconazole reduce serum concentrations of 4β-hydroxycholesterol, which is a validated marker for hepatic cytochrome P450 (CYP) 3A4 activity. We tested the effect of another antifungal triazole agent, fluconazole, on serum concentrations of different sterols and oxysterols within the cholesterol metabolism to see if this inhibitory reaction is a general side effect of azole antifungal agents.
METHODS


In a prospective, double-blind, placebo-controlled, two-way crossover design, we studied 17 healthy subjects (nine men, eight women) who received 400 mg fluconazole or placebo daily for 8 days. On day 1 before treatment and on day 8 after the last dose, fasting blood samples were collected. Serum cholesterol precursors and oxysterols were measured by gas chromatography-mass spectrometry-selected ion monitoring and expressed as the ratio to cholesterol (R_sterol).
RESULTS


Under fluconazole treatment, serum R_lanosterol and R_24,25-dihydrolanosterol increased significantly without affecting serum cholesterol or metabolic downstream markers of hepatic cholesterol synthesis. Serum R_4β-, R_24S-, and R_27-hydroxycholesterol increased significantly.
CONCLUSION


Fluconazole inhibits the 14α-demethylation of lanosterol and 24,25-dihydrolanosterol, regulated by CYP51A1, without reduction of total cholesterol synthesis. The increased serum level of R_4β-hydroxycholesterol under fluconazole treatment is in contrast to the reductions observed under ketoconazole and itraconazole treatments. The question, whether this increase is caused by induction of CYP3A4 or by inhibition of the catabolism of 4β-hydroxycholesterol, must be answered by mechanistic in vitro and in vivo studies comparing effects of various azole antifungal agents on hepatic CYP3A4 activity.",2020,"Fluconazole inhibits the 14α-demethylation of lanosterol and 24,25-dihydrolanosterol, regulated by CYP51A1, without reduction of total cholesterol synthesis.","['17 healthy subjects (nine men, eight women) who received 400\xa0mg', 'daily for 8\xa0days']","['itraconazole', 'ketoconazole and itraconazole', 'ketoconazole', 'fluconazole treatment', 'Fluconazole', 'fluconazole or placebo', 'placebo', 'fluconazole']","['Serum cholesterol precursors and oxysterols', 'total cholesterol synthesis', 'serum cholesterol or metabolic downstream markers of hepatic cholesterol synthesis', 'serum level of R_4β-hydroxycholesterol', 'serum R_lanosterol and R_24,25-dihydrolanosterol', 'Serum R_4β-, R_24S-, and R_27-hydroxycholesterol increased significantly', 'Serum 4β-hydroxycholesterol']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C4277571', 'cui_str': 'Oxysterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",17.0,0.0428714,"Fluconazole inhibits the 14α-demethylation of lanosterol and 24,25-dihydrolanosterol, regulated by CYP51A1, without reduction of total cholesterol synthesis.","[{'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Lütjohann', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. dieter.luetjohann@ukbonn.de.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Stellaard', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Kerksiek', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Lötsch', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe-University Frankfurt, Theodor Stern Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Oertel', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe-University Frankfurt, Theodor Stern Kai 7, 60590, Frankfurt, Germany.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-03041-5']
2121,33201438,Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial.,"INTRODUCTION


In the IMPACT trial, single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduced moderate/severe exacerbation rates versus FF/VI or UMEC/VI dual therapy in patients with chronic obstructive pulmonary disease (COPD); however, pneumonia incidence was higher in FF-containing arms. As COPD is a growing problem in Asia, we compared the efficacy and safety of FF/UMEC/VI in Asia versus non-Asia regions.
METHODS


IMPACT was a double-blind, 52-week trial in symptomatic COPD patients with ≥ 1 moderate/severe exacerbation in the prior year. This pre-specified analysis evaluated the annual rate of moderate/severe exacerbations, change from baseline in trough forced expiratory volume in 1 s, and St George's Respiratory Questionnaire total score, mortality, and safety (including pneumonia) in Asia versus non-Asia regions.
RESULTS


The intent-to-treat population comprised 10,355 patients (Asia n = 1644 [16%]). Rate ratios (95% confidence intervals) for moderate/severe exacerbations with FF/UMEC/VI were 0.89 (0.76-1.05) versus FF/VI and 0.86 (0.71-1.04) versus UMEC/VI in Asia, and 0.84 (0.79-0.90) and 0.74 (0.68-0.80) in non-Asia. Efficacy of FF/UMEC/VI on other endpoints was similar in both regions. There was an increased incidence of investigator-reported pneumonia in patients in Asia (FF/UMEC/VI: 13%; FF/VI: 14%; UMEC/VI: 6%) compared with non-Asia (FF/UMEC/VI: 6%; FF/VI: 5%; UMEC/VI: 4%). The increased risk of pneumonia in patients in Asia was most marked in patients with lower body mass index, lower lung function, and taking inhaled corticosteroids. In post hoc analysis of adjudicated on-treatment all-cause mortality, probabilities of death were numerically lower in both regions with FF/UMEC/VI (Asia: 1.16%; non-Asia: 1.35%) and FF/VI (Asia: 1.77%; non-Asia: 1.21%) versus UMEC/VI (Asia: 1.91%; non-Asia: 2.23%).
CONCLUSIONS


FF/UMEC/VI provides similar benefits in COPD patients in Asia and non-Asia regions. Clinical benefits of treatment, including reduction in mortality risk, should be weighed against risk of pneumonia, taking account of all known risk factors.
TRIAL REGISTRATION


ClinicalTrials.gov identification, NCT02164513.",2020,"The increased risk of pneumonia in patients in Asia was most marked in patients with lower body mass index, lower lung function, and taking inhaled corticosteroids.","['Chronic Obstructive Pulmonary Disease in Asian Countries', 'COPD patients in Asia and non-Asia regions', 'patients with chronic obstructive pulmonary disease (COPD', 'symptomatic COPD patients with\u2009≥\u20091 moderate/severe exacerbation in the prior year']","['FF/UMEC', 'Triple Versus Dual Combination Therapy']","['incidence of investigator-reported pneumonia', 'moderate/severe exacerbation rates', 'risk of pneumonia', ""trough forced expiratory volume in 1\xa0s, and St George's Respiratory Questionnaire total score, mortality, and safety (including pneumonia"", 'mortality, probabilities of death', 'pneumonia incidence', 'Rate ratios']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.676965,"The increased risk of pneumonia in patients in Asia was most marked in patients with lower body mass index, lower lung function, and taking inhaled corticosteroids.","[{'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK. d.halpin@nhs.net.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Pulmonary and Critical Care, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hartley', 'Affiliation': 'Veramed Ltd, Twickenham, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Motokazu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Respiratory Institute, Kamei Hospital, Kishiwada, Osaka, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Manchester University NHS Foundation Trust, University of Manchester, Manchester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]",Pulmonary therapy,['10.1007/s41030-020-00136-3']
2122,33201520,"Proof of Pharmacology of Org 48775-0, a p38 MAP kinase inhibitor, in Healthy Volunteers.","AIM


To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of the highly selective oral p38alpha/beta MAP kinase inhibitor Org 48775-0 in a first-in-human study.
METHODS


In the SAD study, an oral dose of Org 48775-0 (0.3 mg to 600 mg) was evaluated in healthy males. In the MAD study, dose levels of 30, 70 and 150 mg were dosed for six consecutive days, twice daily. Both studies were performed in a double-blind, randomized, placebo-controlled, cross-over fashion and evaluated pharmacokinetics, pharmacodynamics (ex vivo inhibition of LPS-induced TNFalpha release) and routine clinical and laboratory data. Pharmacokinetic and pharmacodynamic parameters of Org 48775-0 were compared between healthy males and postmenopausal females, and the effect of a standardized fat meal was evaluated.
RESULTS


All adverse events observed in the SAD (16; dizziness and headache, diarrhoea, and catheter-related phlebitis) and MAD (43; mainly somnolence, dizziness, headache and nasopharyngitis) cohorts were mild, transient and completely reversible. Pharmacokinetics were linear up to single doses of 400 mg. Median Tmax ranged from 0.5 to 1.8 hours, geometric mean for T1/2 from 7.0 to 14.4 hours. Org 48775-0 doses equal to and greater than 30 mg significantly inhibited LPS-induced TNFalpha release (42.3%; 95%CI=-65.2; -4.3) compared to placebo. In the MAD study, Org 48775-0 treatment inhibited LPS-induced TNFalpha release during the entire steady state period. Levels of inhibition amounted 30-75% for 30 mg, 53-80% for 70 mg, and 77-92% for 150 mg Org 48775-0.
CONCLUSION


Org 48775-0 has the capacity to significantly inhibit MAP kinase activity in humans, without safety concerns.",2020,"All adverse events observed in the SAD (16; dizziness and headache, diarrhoea, and catheter-related phlebitis) and MAD (43; mainly somnolence, dizziness, headache and nasopharyngitis) cohorts were mild, transient and completely reversible.","['healthy males', 'Healthy Volunteers', 'healthy males and postmenopausal females']",['placebo'],"['LPS-induced TNFalpha release', 'Levels of inhibition', 'Median Tmax', 'dizziness and headache, diarrhoea, and catheter-related phlebitis) and MAD (43; mainly somnolence, dizziness, headache and nasopharyngitis', 'safety, tolerability, pharmacokinetics and pharmacodynamics']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",,0.0976526,"All adverse events observed in the SAD (16; dizziness and headache, diarrhoea, and catheter-related phlebitis) and MAD (43; mainly somnolence, dizziness, headache and nasopharyngitis) cohorts were mild, transient and completely reversible.","[{'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Moerland', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Kales', 'Affiliation': 'Former affiliation Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Broekhuizen', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Nässander', 'Affiliation': 'Former affiliation Organon/Schering Plough, Oss, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Nelissen', 'Affiliation': 'Former affiliation Organon/Schering Plough, Oss, The Netherlands.'}, {'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'de Kam', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'Pierre A M', 'Initials': 'PAM', 'LastName': 'Peeters', 'Affiliation': 'Former affiliation Organon/Schering Plough, Oss, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, the Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14655']
2123,33201535,"A pilot randomized, controlled, double-blind trial of bumetanide to treat neonatal seizures Controlled bumetanide trial for neonatal seizures.","OBJECTIVE


In the absence of controlled trials, treatment of neonatal seizures has changed minimally despite poor drug efficacy. We tested bumetanide added to phenobarbital to treat neonatal seizures in the first trial to include a standard-therapy control group.
METHODS


A randomized, double-blind, dose-escalation design was employed. Neonates with postmenstrual age 33-44weeks at risk of or with seizures were eligible. Subjects with EEG-confirmed seizures after ≥20 and <40mg/kg phenobarbital were randomized to receive additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide (treatment). Continuous EEG monitoring data from ≥2 hours before to ≥48 hours after study drug administration (SDA) were analyzed for seizures.
RESULTS


Subjects were randomized to treatment (n=27) and control (n=16) groups. Pharmacokinetics were highly variable among subjects and altered by hypothermia. The only statistically significant adverse event was diuresis in treated subjects (48% vs. 13%, P=0.02). One treated (4%) and three control subjects died (19%, P=0.14). Among survivors, 2/26 treated subjects (8%) and 0/13 control subjects had hearing impairment, as did one non-randomized subject. Total seizure burden varied widely, with much higher seizure burden in treatment vs. control groups (median 3.1 vs. 1.2 minutes/hour, P=0.006). There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
INTERPRETATION


While definitive proof of efficacy awaits an appropriately powered phase III trial, this randomized, controlled, multicenter trial demonstrated an additional reduction in seizure burden attributable to bumetanide over phenobarbital without increased serious adverse effects. Future trials of bumetanide and other drugs should include a control group and balance seizure severity. This article is protected by copyright. All rights reserved.",2020,"There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
","['Subjects with EEG-confirmed seizures after ≥20 and <40mg/kg phenobarbital', 'neonatal seizures', 'Subjects were randomized to treatment (n=27) and control (n=16) groups', 'Neonates with postmenstrual age 33-44weeks at risk of or with seizures were eligible']","['phenobarbital', 'additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide', 'bumetanide']","['Total seizure burden', 'adverse event was diuresis', 'seizure burden', 'hearing impairment']","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0006376', 'cui_str': 'Bumetanide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.392446,"There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
","[{'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Soul', 'Affiliation': ""Departments of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Bergin', 'Affiliation': ""Departments of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stopp', 'Affiliation': ""Departments of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Breda', 'Initials': 'B', 'LastName': 'Hayes', 'Affiliation': ""Departments of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ""Departments of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Carmen Rosa', 'Initials': 'CR', 'LastName': 'Fortuno', 'Affiliation': ""Departments of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': ""Departments of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Kalpathy', 'Initials': 'K', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Jensen', 'Affiliation': ""Departments of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Rofeberg', 'Affiliation': ""Departments of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vinks', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Departments of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Staley', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25959']
2124,33196446,One-step anatomic and function testing by cardiac CT versus second-line functional testing in symptomatic patients with coronary artery stenosis: head-to-head comparison of CT-derived fractional flow reserve and myocardial perfusion imaging.,"AIMS


CT-QFR is a novel coronary computed tomography angiography (CTA) based method for on-site evaluation of patients with suspected obstructive coronary artery disease (CAD). We compared the diagnostic performance of CT-QFR with myocardial perfusion scintigraphy (MPS) and cardiovascular magnetic resonance (CMR) as second-line tests in patients with suspected obstructive CAD after coronary CTA.
METHODS AND RESULTS


Paired analysis of CT-QFR and MPS or CMR, with an invasive FFR-based classification as reference standard. Symptomatic patients with &gt;50% diameter stenosis on coronary CTA were randomized to MPS or CMR and referred for invasive coronary angiography. The rate of coronary CTA not feasible for CT-QFR analysis was 17%. Paired patient-level data were available for 118 patients in the MPS group and 113 in the CMR group, respectively. Patient-level diagnostic accuracy was better for CT-QFR than for both MPS ((82.2% (95%CI 75.2-89.2) vs. 70.3% (95%CI 62.0-78.7), p=0.029) and CMR ((77.0% (95%CI 69.1-84.9) vs. 65.5% (95%CI 56.6-74.4), p=0.047). Following a positive coronary CTA and with the intention-to diagnose, CT-QFR, CMR and MPS were equally suitable as rule-in and rule-out modalities.
CONCLUSIONS


The diagnostic performance of CT-QFR as second-line test was at least similar to MPS and CMR for the evaluation of obstructive coronary artery disease in symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA.",2020,The diagnostic performance of CT-QFR as second-line test was at least similar to MPS and CMR for the evaluation of obstructive coronary artery disease in symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA.,"['Symptomatic patients with &gt;50% diameter stenosis on coronary CTA', 'patients with suspected obstructive coronary artery disease (CAD', 'patients with suspected obstructive CAD after coronary CTA', 'symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA', 'symptomatic patients with coronary artery stenosis']","['coronary computed tomography angiography (CTA', 'CT-QFR with myocardial perfusion scintigraphy (MPS) and cardiovascular magnetic resonance (CMR', 'CT-QFR', 'MPS or CMR', 'cardiac CT versus second-line functional testing', 'MPS and CMR']","['rate of coronary CTA not feasible for CT-QFR analysis', 'Patient-level diagnostic accuracy', 'CMR']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}]",,0.0943377,The diagnostic performance of CT-QFR as second-line test was at least similar to MPS and CMR for the evaluation of obstructive coronary artery disease in symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA.,"[{'ForeName': 'Jelmer', 'Initials': 'J', 'LastName': 'Westra', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Zehang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Laust Dupont', 'Initials': 'LD', 'LastName': 'Rasmussen', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Winther', 'Affiliation': ''}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Nissen', 'Affiliation': ''}, {'ForeName': 'Steffen E', 'Initials': 'SE', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'June Anita', 'Initials': 'JA', 'LastName': 'Ejlersen', 'Affiliation': ''}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Isaksen', 'Affiliation': ''}, {'ForeName': 'Lars Christian', 'Initials': 'LC', 'LastName': 'Gormsen', 'Affiliation': ''}, {'ForeName': 'Grazina', 'Initials': 'G', 'LastName': 'Urbonaviciene', 'Affiliation': ''}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Eftekhari', 'Affiliation': ''}, {'ForeName': 'Tingwen', 'Initials': 'T', 'LastName': 'Weng', 'Affiliation': ''}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': ''}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': ''}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': ''}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bøttcher', 'Affiliation': ''}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00905']
2125,33196448,Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial).,"BACKGROUND


Despite the large impact that dietary habits have in the management of diabetes, few tools for supporting healthy eating habits are available for persons with diabetes.
OBJECTIVE


The aim of this randomized clinical trial is to evaluate the effect of a 12-week, mobile health (mHealth), app-based intervention promoting healthy eating habits among patients with type 2 diabetes.
METHODS


The HAPPY (Healthy eating using APP technologY) trial is a randomized clinical trial with two arms aiming to include 200 patients, 18 years of age or older, with type 2 diabetes. Both women and men are eligible for inclusion. Study participants are randomized 1:1 to an intervention group, where they are instructed to use a smartphone app promoting healthy eating, or to a control group, where they receive standard primary care only, for a period of 12 weeks. Each week a new topic (eg, vegetable intake) is introduced via the app. After an introduction text, the user is given a topic-related activity to perform (eg, eat one additional serving of vegetables per day during that week). The app records daily progress and sends automatic reminders or feedback to the user. Dietary intake, body composition, clinical variables, and biomarkers are measured at baseline and at 3- and 6-month follow-ups. An extensive web-based questionnaire comprising several validated questionnaires assessing a number of lifestyle factors is distributed via email at baseline and at 3-, 6-, and 12-month follow-ups; lifestyle factors include, for example, sleep, physical activity, eating behavior, and health-related quality of life. The effect of the intervention on dietary intake (primary outcome) and on glycated hemoglobin and blood lipid levels, body composition, blood pressure, other lifestyle factors, and overall health (secondary outcomes) will be assessed.
RESULTS


Data collection is ongoing. Recruitment of participants started in January 2019. Findings from the study are expected to be published by the end of 2021.
CONCLUSIONS


Technology development provides new ways to promote and support long-term adherence to healthier eating habits. mHealth-based approaches allow for real-time interaction and the delivery of an intervention at any time. Further, focusing on overall diet allows the user to apply new knowledge to current eating patterns, creating an individualized approach. In this study, we evaluate the effect of using a new smartphone app promoting healthy eating habits on dietary intake, clinical markers, and lifestyle factors among patients with type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03784612; https://clinicaltrials.gov/ct2/show/NCT03784612.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/24422.",2020,"The effect of the intervention on dietary intake (primary outcome) and on glycated hemoglobin and blood lipid levels, body composition, blood pressure, other lifestyle factors, and overall health (secondary outcomes) will be assessed.
","['participants started in January 2019', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes', 'persons with diabetes', 'healthy eating habits among patients with type 2 diabetes', '200 patients, 18 years of age or older, with type 2 diabetes', 'Healthier Eating Habits']","['mobile health (mHealth), app-based intervention', 'smartphone app promoting healthy eating, or to a control group, where they receive standard primary care', 'new smartphone app promoting healthy eating habits', 'HAPPY ']","['Dietary intake, body composition, clinical variables, and biomarkers', 'glycated hemoglobin and blood lipid levels, body composition, blood pressure, other lifestyle factors, and overall health (secondary outcomes', 'example, sleep, physical activity, eating behavior, and health-related quality of life']","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.124242,"The effect of the intervention on dietary intake (primary outcome) and on glycated hemoglobin and blood lipid levels, body composition, blood pressure, other lifestyle factors, and overall health (secondary outcomes) will be assessed.
","[{'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Dahlgren', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Sjöblom', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Solna, Sweden.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Bonn', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Solna, Sweden.'}]",JMIR research protocols,['10.2196/24422']
2126,33196449,A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping.
OBJECTIVE


This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system.
METHODS


A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group).
RESULTS


The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen d index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic.
CONCLUSIONS


The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/23117.",2020,Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat.,['166 participants (83 per group'],"['self-administered web-based intervention (Mental Health COVID-19', 'cognitive behavioral therapy and behavioral activation therapy', 'Multicomponent Web-Based Mental Health Intervention', 'self-administered intervention with assistance via chat or self-administered intervention without assistance via chat']",['symptoms of anxiety and depression and increase positive emotions and sleep quality'],"[{'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",166.0,0.269266,Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat.,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Dominguez-Rodriguez', 'Affiliation': 'Valencian International University, Valencia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'De La Rosa-Gómez', 'Affiliation': 'Coordinación de Educación a Distancia, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'M Jesús', 'Initials': 'MJ', 'LastName': 'Hernández Jiménez', 'Affiliation': 'Valencian International University, Valencia, Spain.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Arenas-Landgrave', 'Affiliation': 'Facultad de Psicología, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'Sofía Cristina', 'Initials': 'SC', 'LastName': 'Martínez-Luna', 'Affiliation': 'Facultad de Psicología, Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'Joabian', 'Initials': 'J', 'LastName': 'Alvarez Silva', 'Affiliation': 'ITLAB Mexico, Juarez, Mexico.'}, {'ForeName': 'José Ernesto', 'Initials': 'JE', 'LastName': 'García Hernández', 'Affiliation': 'Plan Estratégico de Juárez A C, Juarez, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Arzola-Sánchez', 'Affiliation': 'Institute of Social Sciences, Autonomous University of Ciudad Juárez, Juarez, Mexico.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Acosta Guzmán', 'Affiliation': 'Institute of Social Sciences, Autonomous University of Ciudad Juárez, Juarez, Mexico.'}]",JMIR research protocols,['10.2196/23117']
2127,33196464,Kisspeptin receptor agonist has therapeutic potential for female reproductive disorders.,"BACKGROUNDKisspeptin is a key regulator of hypothalamic gonadotropin-releasing hormone (GnRH) neurons and is essential for reproductive health. A specific kisspeptin receptor (KISS1R) agonist could significantly expand the potential clinical utility of therapeutics targeting the kisspeptin pathway. Herein, we investigate the effects of a KISS1R agonist, MVT-602, in healthy women and in women with reproductive disorders.METHODSWe conducted in vivo and in vitro studies to characterize the action of MVT-602 in comparison with native kisspeptin-54 (KP54). We determined the pharmacokinetic and pharmacodynamic properties of MVT-602 (doses 0.01 and 0.03 nmol/kg) versus KP54 (9.6 nmol/kg) in the follicular phase of healthy women (n = 9), and in women with polycystic ovary syndrome (PCOS; n = 6) or hypothalamic amenorrhea (HA; n = 6). Further, we investigated their effects on KISS1R-mediated inositol monophosphate (IP1) and Ca2+ signaling in cell lines and on action potential firing of GnRH neurons in brain slices.RESULTSIn healthy women, the amplitude of luteinizing hormone (LH) rise was similar to that after KP54, but peaked later (21.4 vs. 4.7 hours; P = 0.0002), with correspondingly increased AUC of LH exposure (169.0 vs. 38.5 IU∙h/L; P = 0.0058). LH increases following MVT-602 were similar in PCOS and healthy women, but advanced in HA (P = 0.004). In keeping with the clinical data, MVT-602 induced more potent signaling of KISS1R-mediated IP1 accumulation and a longer duration of GnRH neuron firing than KP54 (115 vs. 55 minutes; P = 0.0012).CONCLUSIONTaken together, these clinical and mechanistic data identify MVT-602 as having considerable therapeutic potential for the treatment of female reproductive disorders.TRIAL REGISTRATIONInternational Standard Randomised Controlled Trial Number (ISRCTN) Registry, ISRCTN21681316.FUNDINGNational Institute for Health Research and NIH.",2020,"LH increases following MVT-602 were similar in PCOS and healthy women, but advanced in HA (P = 0.004).","['healthy women and in women with reproductive disorders', 'healthy women (n = 9), and in women with polycystic ovary syndrome (PCOS; n = 6) or hypothalamic amenorrhea (HA; n = 6', 'healthy women', 'female reproductive disorders']","['MVT-602', 'Kisspeptin receptor agonist', 'native kisspeptin-54 (KP54', 'KISS1R agonist, MVT-602', 'KP54']","['LH increases following MVT-602', 'AUC of LH exposure', 'amplitude of luteinizing hormone (LH) rise']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0236100', 'cui_str': 'Disorder of female reproductive system'}]","[{'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C3146273', 'cui_str': 'Metastins'}, {'cui': 'C4318433', 'cui_str': 'Kisspeptin-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0520970', 'cui_str': 'Hormone increase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0570407,"LH increases following MVT-602 were similar in PCOS and healthy women, but advanced in HA (P = 0.004).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Clarke', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Richardson', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Charlene M', 'Initials': 'CM', 'LastName': 'Sykes', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Chayarndorn', 'Initials': 'C', 'LastName': 'Phumsatitpong', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Purugganan', 'Affiliation': 'Hammersmith IVF unit, and.'}, {'ForeName': 'Channa N', 'Initials': 'CN', 'LastName': 'Jayasena', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': ""St Mary's Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom.""}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Salim', 'Affiliation': 'Hammersmith IVF unit, and.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Owen', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'McArdle', 'Affiliation': 'Department of Translational Medicine, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Margaritis', 'Initials': 'M', 'LastName': 'Voliotis', 'Affiliation': 'Department of Mathematics and Living Systems Institute, and.'}, {'ForeName': 'Krasimira', 'Initials': 'K', 'LastName': 'Tsaneva-Atanasova', 'Affiliation': 'Department of Mathematics and Living Systems Institute, and.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Moenter', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Hanyaloglu', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}]",The Journal of clinical investigation,['10.1172/JCI139681']
2128,33198663,CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth risk.,"BACKGROUND


Full dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown.
METHODS


There are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG).
CRAFT-OBS


Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth.
CRAFT-RCT


Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section.
CRAFT-IMG


Imaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche.
DISCUSSION


The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies.
TRIAL REGISTRATION


CRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ).",2020,"The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies.
","['preterm birth risk', 'preterm birth in women with a prior caesarean section in established labour', 'women with previous in-labour caesarean section', 'women with a previous fully dilated caesarean section, such as scar position and niche', '25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ', 'after full dilatation caesarean section', 'short cervix in women at high risk of preterm birth following a fully dilated caesarean section']","['CRAFT (Cerclage', 'CRAFT-RCT', 'transvaginal ultrasound and quantitative fetal fibronectin']",[],"[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0806123', 'cui_str': 'Fetal fibronectin'}]",[],,0.229838,"The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies.
","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Carlisle', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK. craftstudy@kcl.ac.uk.""}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Glazewska-Hallin', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK. craftstudy@kcl.ac.uk.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Story', 'Affiliation': ""Centre for the Developing Brain, King's College London, 1st Floor South Wing, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Suff', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Giblin', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hutter', 'Affiliation': ""Centre for the Developing Brain, King's College London, 1st Floor South Wing, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Napolitano', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, Room 244, Medical School Building, Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rutherford', 'Affiliation': ""Centre for the Developing Brain, King's College London, 1st Floor South Wing, St Thomas' Hospital, London, SE1 7EH, UK.""}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Alexander', 'Affiliation': 'Department of Computer Science, University College London, Gower Street, London, WC1E 6BT, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Simpson', 'Affiliation': 'Delivery Suite, C Floor, Clarendon Wing, The General Infirmary at Leeds, Belmont Grove, Leeds, LS2 9NS, UK.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, Room 244, Medical School Building, Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'David', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, Room 244, Medical School Building, Huntley Street, London, WC1E 6AU, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10th Floor, North Wing, St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.""}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03375-z']
2129,33198679,Safety and efficacy of manual vacuum suction compared with conventional dilatation and sharp curettage and electric vacuum aspiration in surgical treatment of miscarriage: a randomized controlled trial.,"BACKGROUND


The World Health Organization does not recommend dilatation and sharp curettage (D&C) for the surgical treatment of miscarriage during the first trimester because this may cause Asherman's syndrome due to endometrial damage; therefore, suction remains the primary treatment option. While manual vacuum aspiration (MVA) has been widely used since the 1990s outside Japan, the use of an MVA device (Women's MVA system) was approved in Japan in October 2015. Here, we examined the efficacy of the MVA kit in women surgically treated for miscarriage.
METHODS


This retrospective cohort study was conducted between 2014 and 2018 at the International University of Health and Welfare Hospital in Japan. Women who underwent surgical treatment for miscarriage within 12 weeks of pregnancy were identified and enrolled in the study. A total of 404 women were included who underwent the following procedures: 121 D&C, 123 electric vacuum aspiration (EVA), and 160 MVA. For each participant, the duration of surgery, amount of bleeding, amount of anesthetic used, incomplete abortion requiring repeat procedures, and intraoperative/postoperative complications were evaluated.
RESULTS


The duration of surgery was 13.7 ± 7.2, 11.2 ± 4.2, and 6.9 ± 4.3 min in the D&C, EVA, and MVA groups, respectively (p = 1.00). The amount of anesthetic used was not significantly different among all groups. Bleeding of ≥ 100 mL was confirmed in three (2.4%), one (0.8%), and one (0.6%) patient(s) in the D&C, EVA, and MVA groups, respectively (p = 0.50). Incomplete abortion was identified in three (2.4%), two (1.6%), and one (0.6%) patient(s) in the D&C, EVA, and MVA groups, respectively (p = 0.61). However, severe intraoperative/postoperative complications were not observed in any group.
CONCLUSIONS


Surgical treatment for miscarriage performed using the MVA kit has safety and efficacy similar to those of conventional methods, such as D&C and EVA.",2020,"CONCLUSIONS


Surgical treatment for miscarriage performed using the MVA kit has safety and efficacy similar to those of conventional methods, such as D&C and EVA.","['women surgically treated for miscarriage', 'surgical treatment of miscarriage', '2014 and 2018\xa0at the International University of Health and Welfare Hospital in Japan', 'Women who underwent surgical treatment for miscarriage within 12 weeks of pregnancy were identified and enrolled in the study', 'A total of 404 women were included who underwent the following procedures: 121 D&C, 123 electric vacuum aspiration (EVA), and 160 MVA']","['conventional dilatation and sharp curettage and electric vacuum aspiration', 'dilatation and sharp curettage (D&C', 'MVA kit', 'manual vacuum suction', 'manual vacuum aspiration (MVA']","['Safety and efficacy', 'severe intraoperative/postoperative complications', 'duration of surgery, amount of bleeding, amount of anesthetic used, incomplete abortion requiring repeat procedures, and intraoperative/postoperative complications', 'Incomplete abortion', 'Bleeding of ≥', 'duration of surgery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0000810', 'cui_str': 'Incomplete miscarriage'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",404.0,0.0475527,"CONCLUSIONS


Surgical treatment for miscarriage performed using the MVA kit has safety and efficacy similar to those of conventional methods, such as D&C and EVA.","[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kakinuma', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan. tokakinuma@gmail.com.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kakinuma', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Yuuka', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Kawarai', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Koyomi', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Motomasa', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Sato', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Ohwada', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Yanagida', 'Affiliation': 'Center for Human Reproduction, International University of Health and Welfare Hospital, 537-3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Obstetrics and Gynecology, International University of Health and Welfare Hospital, 537- 3 Iguchi, 329-2763, Nasushiobara City, Tochigi, Japan.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03362-4']
2130,33198694,Correction to: Cost-effectiveness of a tailored intervention designed to increase breast cancer screening among a non-adherent population: a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['a non-adherent population'],[],['breast cancer screening'],"[{'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0281182', 'cui_str': 'Screening for malignant neoplasm of breast'}]",,0.0217504,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Public Health, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': 'Center of the Study for Communication Design & Support Office for Large-scale Education and Research Projects, Osaka University, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Screening Assessment & Management Division, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. hrsaito@ncc.go.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fukuyoshi', 'Affiliation': 'Cancer Scan, Tokyo, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Yonekura', 'Affiliation': 'Cancer Scan, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Japan Society for the Promotion of Science, Tokyo, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Seki', 'Affiliation': 'Faculty of Human Sciences, Osaka University, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibuya', 'Affiliation': 'Cancer Detection Center, Miyagi Cancer Society, Miyagi, Japan.'}, {'ForeName': 'Yosikazu', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Public Health, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}]",BMC public health,['10.1186/s12889-020-09822-y']
2131,33198697,Correction to: Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['colorectal cancer screening among a non-adherent population'],['Correction to: Tailored message interventions versus typical messages'],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0421731,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': 'Graduate School of Human Sciences, and Graduate School of Medicine, Osaka University, 2-2, Yamadaoka, Suita-shi, Osaka, 565-0871, Japan. khirai@grappo.jp.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Health and Social Behavior, School of Public Health, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fukuyoshi', 'Affiliation': 'Cancer Scan, Tokyo, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Yonekura', 'Affiliation': 'Cancer Scan, Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Harada', 'Affiliation': 'Graduate School of Human Development and Environment, Kobe University, Kobe, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibuya', 'Affiliation': 'Cancer Detection Center, Miyagi Cancer Society, Miyagi, Japan.'}, {'ForeName': 'Seiichiro', 'Initials': 'S', 'LastName': 'Yamamoto', 'Affiliation': 'Public Health Policy Research Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Mizota', 'Affiliation': 'Public Health Policy Research Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Hamashima', 'Affiliation': 'Screening Assessment and Management Division, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Screening Assessment and Management Division, National Cancer Center, Tokyo, Japan.'}]",BMC public health,['10.1186/s12889-020-09823-x']
2132,33198700,"Effectiveness of an individual acceptance and commitment therapy for smoking cessation, delivered face-to-face and by telephone to adults recruited in primary health care settings: a randomized controlled trial.","BACKGROUND


The aim of this study was to examine the effectiveness of delivering an individual Acceptance and Commitment Therapy (ACT) for smoking cessation among a Chinese population.
METHODS


Participants were recruited from six primary health care centers. A total of 144 were eligible to take part in the study and agreed to be randomized to the intervention (ACT) group (n = 70) and control group (n = 74), respectively. Both groups received self-help materials on smoking cessation. The ACT group also underwent an initial face-to-face session and two telephone ACT sessions at 1 week and 1 month following the first session. They were re-contacted through telephone follow-ups at 3, 6, and 12 months by research assistants. The primary outcome was self-reported 7-day point-prevalence abstinence at the 12-month follow-up session. Other outcomes included biochemically validated quitting, quitting attempts, the intention to quit, the self-perception of quitting, and psychological flexibility.
RESULTS


There was no significant difference in the self-reported 7-day point prevalence quit rate at the 12-month follow-up between the intervention group (24.3%) and the control group (21.6%) (risk ratio = 1.12; 95%CI = (0.62, 2.05); p = 0.704). Greater improvements in secondary outcomes from baseline to the 12-month follow-up were observed in the ACT group than in the control group, including a forward progression in the participants' readiness to quit smoking (p = 0.014) and increased psychological flexibility (p = 0.022).
CONCLUSIONS


This study is the first evidence of a randomized-controlled trial on the adoption of an individual ACT for smoking cessation, delivered initially in primary health care settings and subsequently by telephone within a Chinese population. The present study found that the brief ACT intervention could not produce a significant quit rate but was promising in terms of bringing about cognitive changes, including greater psychological flexibility, and more confidence about quitting, when compared to the use of self-help materials only among the general population.
TRIAL REGISTRATION


This trial was registered prospectively with the U.S. National Library of Medicine: ( NCT01652508 ) on 26th July 2012.",2020,"There was no significant difference in the self-reported 7-day point prevalence quit rate at the 12-month follow-up between the intervention group (24.3%) and the control group (21.6%) (risk ratio = 1.12; 95%CI = (0.62, 2.05); p = 0.704).","['adults recruited in primary health care settings', 'primary health care settings and subsequently by telephone within a Chinese population', 'Participants were recruited from six primary health care centers', 'A total of 144 were eligible to take part in the study and agreed to be randomized to the']","['individual acceptance and commitment therapy', 'ACT intervention', 'intervention (ACT', 'individual Acceptance and Commitment Therapy (ACT']","['validated quitting, quitting attempts, the intention to quit, the self-perception of quitting, and psychological flexibility', 'self-reported 7-day point-prevalence abstinence', 'psychological flexibility', 'self-reported 7-day point prevalence quit rate', 'quit rate', 'readiness to quit smoking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",144.0,0.0856667,"There was no significant difference in the self-reported 7-day point prevalence quit rate at the 12-month follow-up between the intervention group (24.3%) and the control group (21.6%) (risk ratio = 1.12; 95%CI = (0.62, 2.05); p = 0.704).","[{'ForeName': 'Yim Wah', 'Initials': 'YW', 'LastName': 'Mak', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Yuk Choi Road, Hung Hom, Kowloon, Hong Kong, Special Administrative Region of China. yw.mak@polyu.edu.hk.'}, {'ForeName': 'Doris Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Yuk Choi Road, Hung Hom, Kowloon, Hong Kong, Special Administrative Region of China.'}, {'ForeName': 'Alice Yuen', 'Initials': 'AY', 'LastName': 'Loke', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Yuk Choi Road, Hung Hom, Kowloon, Hong Kong, Special Administrative Region of China.'}]",BMC public health,['10.1186/s12889-020-09820-0']
2133,33198735,Association of adipocytokines with lipid and glycemic profiles in women with normal weight obesity.,"BACKGROUND


Individuals with normal weight obesity (NWO) are predisposed to having cardiometabolic disorders. This study aims to investigate the circulating levels of vaspin, leptin and their association with glycemic and lipid profiles in women with NWO.
METHODS


Forty women with body mass index (BMI) = 18.5-24.9 kg/m 2  and fat mass (FM) ≥ 30% were assigned in the NWO group. Thirty age-matched women with identical BMI range, and FM < 30% (normal weight non-obese; NWNO) were considered as a control group. In addition to anthropometric measurements, glycemic and lipid profiles and circulating levels of leptin and vaspin were measured.
RESULTS


The mean ± standard deviation (SD) age of participants was 28.76 ± 4.76 years in the NWO group and 29.23 ± 4.50 years in the control group. The NWO group had the higher mean serum levels of insulin (9.02 ± 4.75 vs. 6.24 ± 2.51, P = 0.009), leptin (17.31 ± 8.10 vs. 9.94 ± 4.30, P < 0.001) and homeostatic model assessment of insulin resistance (HOMA-IR) (33.77 ± 20.71 vs. 23.48 ± 10.03, P = 0.009) compared to the NWNO group. The serum level of vaspin was higher in the NWO group compared to the control group (34.82 pg/ml vs. 27.72 pg/ml, respectively, P = 0.12). In NWO group, the serum levels of leptin had positive correlation with FBS (r = 0.45, P = 0.02), insulin (r = 0.51, P = 0.008), and HOMA-IR (r = 0.46, P = 0.02) and vaspin concentration was associated with insulin (r = 0.36, P = 0.02) and HOMA-IR (r = 0.30, P = 0.06), positively.
CONCLUSION


It is concluded that the concentration of insulin and HOMA-IR index were significantly higher in women with NWO compared to NWNO. Higher concentrations of leptin and vaspin in the NWO group were associated with glycemic profile.",2020,"The serum level of vaspin was higher in the NWO group compared to the control group (34.82 pg/ml vs. 27.72 pg/ml, respectively, P = 0.12).","['Forty women with body mass index (BMI)\u2009=\u200918.5-24.9\u2009kg/m 2  and fat mass (FM', 'Individuals with normal weight obesity (NWO', 'age of participants was 28.76\u2009±\u20094.76\u2009years in the NWO group and 29.23\u2009±\u20094.50\u2009years in the control group', 'Thirty age-matched women with identical BMI range, and FM\u2009<\u200930% (normal weight non-obese; NWNO', 'women with normal weight obesity', 'women with NWO']",[],"['mean serum levels of insulin', 'concentration of insulin and HOMA-IR index', 'homeostatic model assessment of insulin resistance (HOMA-IR', 'HOMA-IR', 'leptin', 'anthropometric measurements, glycemic and lipid profiles and circulating levels of leptin and vaspin', 'serum levels of leptin had positive correlation with FBS', 'mean\u2009±\u2009standard deviation (SD', 'serum level of vaspin', 'vaspin concentration', 'Higher concentrations of leptin and vaspin']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205250', 'cui_str': 'High'}]",40.0,0.0741714,"The serum level of vaspin was higher in the NWO group compared to the control group (34.82 pg/ml vs. 27.72 pg/ml, respectively, P = 0.12).","[{'ForeName': 'Ehsaneh', 'Initials': 'E', 'LastName': 'Taheri', 'Affiliation': 'Student Research Committee, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, 19839-63113, Iran. ehsaneh_taheri@yahoo.com.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Scientists and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mirmiran', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. parven.mirmirran@gmail.com.'}]",BMC endocrine disorders,['10.1186/s12902-020-00648-8']
2134,33198760,Low levels of fine particulate matter increase vascular damage and reduce pulmonary function in young healthy adults.,"BACKGROUND


Fine particulate matter (PM 2.5 ) related mild inflammation, altered autonomic control of cardiovascular function, and changes to cell function have been observed in controlled human exposure studies.
METHODS


To measure the systemic and cardiopulmonary impacts of low-level PM exposure, we exposed 20 healthy, young volunteers to PM 2.5 , in the form of concentrated ambient particles (mean: 37.8 μg/m 3 , SD 6.5), and filtered air (mean: 2.1 μg/m 3 , SD 2.6). In this double-blind, crossover study the exposure order was randomized. During the 4 h exposure, volunteers (7 females and 13 males) underwent light intensity exercise to regulate ventilation rate. We measured pulmonary, cardiac, and hematologic end points before exposure, 1 h after exposure, and again 20 h after exposure.
RESULTS


Low-level PM 2.5  resulted in both pulmonary and extra-pulmonary changes characterized by alterations in systematic inflammation markers, cardiac repolarization, and decreased pulmonary function. A mean increase in PM 2.5  concentration (37.8 μg/m 3 ) significantly increased serum amyloid A (SAA), C-reactive protein (CRP), soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1), 1 h after exposure by 8.7, 9.1, 10.7, and 6.6%, respectively, relative to the filtered air control. SAA remained significantly elevated (34.6%) 20 h after PM 2.5  exposure which was accompanied by a 5.7% decrease in percent neutrophils. Decreased pulmonary function was observed 1 h after exposure through a 0.8 and 1.2% decrease in forced expiratory volume in 1 s (FEV 1 ) and FEV 1 / forced vital capacity (FEV 1 /FVC) respectively. Additionally, sex specific changes were observed in repolarization outcomes following PM 2.5  exposure. In males, P-wave and QRS complex were increased by 15.4 and 5.4% 1 h after exposure.
CONCLUSIONS


This study is the first controlled human exposure study to demonstrate biological effects in response to exposure to concentrated ambient air PM 2.5  particles at levels near the PM 2.5  US NAAQS standard.
CLINICAL TRIAL REGISTRATION INFORMATION


clinicaltrials.gov ; Identifier: NCT03232086 . The study was registered retrospectively on July 25, 2017, prior to final data collection on October 25, 2017 and data analysis.",2020,"A mean increase in PM 2.5  concentration (37.8 μg/m 3 ) significantly increased serum amyloid A (SAA), C-reactive protein (CRP), soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1), 1 h after exposure by 8.7, 9.1, 10.7, and 6.6%, respectively, relative to the filtered air control.","['volunteers (7 females and 13 males', 'young healthy adults', '20 healthy, young volunteers to PM 2.5 , in the form of concentrated ambient particles (mean: 37.8\u2009μg/m 3 , SD 6.5), and filtered air (mean: 2.1\u2009μg/m 3 , SD 2.6', 'The study was registered retrospectively on July 25, 2017, prior to final data collection on October 25, 2017 and data analysis']",['light intensity exercise'],"['systematic inflammation markers, cardiac repolarization, and decreased pulmonary function', 'SAA', 'repolarization outcomes', 'serum amyloid A (SAA), C-reactive protein (CRP), soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1), 1\u2009h after exposure', 'pulmonary function', 'forced expiratory volume', 'QRS complex', 'PM 2.5  concentration', 'Decreased pulmonary function']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0429097', 'cui_str': 'QRS complex feature'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",20.0,0.0504497,"A mean increase in PM 2.5  concentration (37.8 μg/m 3 ) significantly increased serum amyloid A (SAA), C-reactive protein (CRP), soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular cell adhesion molecule-1 (sVCAM-1), 1 h after exposure by 8.7, 9.1, 10.7, and 6.6%, respectively, relative to the filtered air control.","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Wyatt', 'Affiliation': 'Public Health and Integrated Toxicology Division, Human Studies Facility, United States Environmental Protection Agency (USEPA), Research Triangle Park, 104 Mason Farm Rd, Chapel Hill, NC, 27514, USA. Wyatt.lauren@epa.gov.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Public Health and Integrated Toxicology Division, Human Studies Facility, United States Environmental Protection Agency (USEPA), Research Triangle Park, 104 Mason Farm Rd, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'Ana G', 'Initials': 'AG', 'LastName': 'Rappold', 'Affiliation': 'Public Health and Integrated Toxicology Division, Human Studies Facility, United States Environmental Protection Agency (USEPA), Research Triangle Park, 104 Mason Farm Rd, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'Martin W', 'Initials': 'MW', 'LastName': 'Case', 'Affiliation': 'Public Health and Integrated Toxicology Division, Human Studies Facility, United States Environmental Protection Agency (USEPA), Research Triangle Park, 104 Mason Farm Rd, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Diaz-Sanchez', 'Affiliation': 'Public Health and Integrated Toxicology Division, Human Studies Facility, United States Environmental Protection Agency (USEPA), Research Triangle Park, 104 Mason Farm Rd, Chapel Hill, NC, 27514, USA.'}]",Particle and fibre toxicology,['10.1186/s12989-020-00389-5']
2135,33198761,Phone-based audience response system as an adjunct in orthodontic teaching of undergraduate dental students: a cross-over randomised controlled trial.,"BACKGROUND


The advent of electronic teaching facilities improves tutor-student communication. This study aims to explore the effectiveness of Phone-Based Audience Response System (PB-ARS), as an adjunctive pedagogy tool to enhance the retention of orthodontic information by dental students; and to explore the students' perception of PB-ARS.
METHODS


This cross-over clustered randomised control trial included 34 males who were in the final year of their undergraduate dental training. Participants were allocated to one of two event groups (G1 and G2) using computer-generated randomisation. Both groups simultaneously attended two different traditional lectures (L 1 and L2) a week apart. During L1, PB-ARS was used as an adjunct to conventional presentation to teach G1 participants, (PB-ARS group) while G2's participants acted as a control group (CG), and were taught using a traditional presentation. In the second week (L2), the interventions were crossed-over. Participants from both groups completed pre- and post-lecture multiple-choice questionnaires (MCQ) to assess their short-term retention of information. Their performance in the final MCQ exam (10 weeks following L2) was tracked to assess the long-term retention of the information. Participants also completed post-lecture questionnaires to evaluate their perceptions.
RESULTS


Twenty-nine and 31 participants from the CG and PB-ARS group completed this trial, respectively. Although 87.5% of students in the PB-ARS group showed an improvement in their immediate post-lecture scores compared with 79.3% for the CG, it was statistically insignificant (p = 0.465). Similarly, the intervention showed an insignificant effect on the long-term retention of the knowledge (p = 0.560). There was a mildly but favourable attitude of students towards the use of PB-ARS. However, the difference in the overall level of satisfaction between both groups was statistically insignificant (p = 0.183).
CONCLUSION


PB-ARS has a minimal and insignificant effect on the short- and long-term retention of orthodontic knowledge by male undergraduate dental students. PB-ARS was the preferred adjunct tool to conventional classroom teaching. Due to the limitations of this trial, a long-term randomised controlled trial with a larger sample size is recommended.",2020,"However, the difference in the overall level of satisfaction between both groups was statistically insignificant (p = 0.183).
","['dental students', 'male undergraduate dental students', '34 males who were in the final year of their undergraduate dental training', 'orthodontic teaching of undergraduate dental students']","['Phone-Based Audience Response System (PB-ARS', 'pre- and post-lecture multiple-choice questionnaires (MCQ', 'Phone-based audience response system']","['long-term retention of the knowledge', 'overall level of satisfaction', 'immediate post-lecture scores']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0627229,"However, the difference in the overall level of satisfaction between both groups was statistically insignificant (p = 0.183).
","[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alharbi', 'Affiliation': 'Department of Preventive Dental Sciences / College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj, 11942, Saudi Arabia.'}, {'ForeName': 'Khulud F', 'Initials': 'KF', 'LastName': 'Alazmi', 'Affiliation': 'Ministry of Health, Kingdom of Saudi Arabia, Riyadh, Saudi Arabia.'}, {'ForeName': 'Bashar R', 'Initials': 'BR', 'LastName': 'El Momani', 'Affiliation': 'Queen Alia Military Hospital, Dental Corps-Orthodontics department, Royal Medical Services of Jordan Armed Forces, Amman, Jordan.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Al-Muzian', 'Affiliation': 'Glasgow Orthodontic Academy, Edinburgh, UK. drlibi@hotmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wertheimer', 'Affiliation': 'Private Orthodontic Practice, Johannesburg, South Africa.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Almukhtar', 'Affiliation': 'College of Dentistry, University of Mosul, Mosul, Iraq.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Almuzian', 'Affiliation': 'Orthodontist (Private clinic, UK) and Honorary Research Fellow, Edinburgh Dental Institute, University of Edinburgh, Edinburgh, UK.'}]",BMC medical education,['10.1186/s12909-020-02363-3']
2136,33198767,"Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial.","BACKGROUND


Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery.
METHODS


The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network's five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
DISCUSSION


The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04060303 . Registered on 07 August 2019.",2020,"BACKGROUND


Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking.","['children undergoing surgery', 'Eighteen (N\u2009=\u200918) participating sites', 'pediatric patients, between 10 and 18\u2009years old, who undergo elective gastrointestinal surgery']","['perioperative enhanced recovery protocol', 'CHildren Undergoing Surgery (ENRICH-US) intervention', 'pediatric-specific ENRICH-US intervention']","['opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes', 'hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0524722', 'cui_str': 'Gastrointestinal surgery'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}]",,0.137905,"BACKGROUND


Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking.","[{'ForeName': 'Mehul V', 'Initials': 'MV', 'LastName': 'Raval', 'Affiliation': 'Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA. mraval@luriechildrens.org.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Wymore', 'Affiliation': 'Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Martha-Conley E', 'Initials': 'ME', 'LastName': 'Ingram', 'Affiliation': 'Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Holl', 'Affiliation': 'Biological Science Division, University of Chicago, 5841 S. Maryland Avenue, Chicago, IL, 60637, USA.'}]",Trials,['10.1186/s13063-020-04851-9']
2137,31978983,The Effect of a Food Addiction Explanation Model for Weight Control and Obesity on Weight Stigma.,"There is increasing scientific and public support for the notion that some foods may be addictive, and that poor weight control and obesity may, for some people, stem from having a food addiction. However, it remains unclear how a food addiction model (FAM) explanation for obesity and weight control will affect weight stigma. In two experiments ( N  = 530 and  N  = 690), we tested the effect of a food addiction explanation for obesity and weight control on weight stigma. In Experiment 1, participants who received a FAM explanation for weight control and obesity reported lower weight stigma scores (e.g., less dislike of 'fat people', and lower personal willpower blame) than those receiving an explanation emphasizing diet and exercise ( F (4 , 525)  = 7.675,  p  = 0.006; and  F (4,525)  = 5.393,  p  = 0.021, respectively). In Experiment 2, there was a significant group difference for the dislike of 'fat people' stigma measure ( F ( 5 , 684)  = 5.157,  p  = 0.006), but not for personal willpower weight stigma ( F ( 5 , 684)  = 0.217,  p  = 0.81). Participants receiving the diet and exercise explanation had greater dislike of 'fat people' than those in the FAM explanation and control group ( p  values < 0.05), with no difference between the FAM and control groups ( p  >0.05). The FAM explanation for weight control and obesity did not increase weight stigma and resulted in lower stigma than the diet and exercise explanation that attributes obesity to personal control. The results highlight the importance of health messaging about the causes of obesity and the need for communications that do not exacerbate weight stigma.",2020,"Participants receiving the diet and exercise explanation had greater dislike of 'fat people' than those in the FAM explanation and control group ( p  values < 0.05), with no difference between the FAM and control groups ( p  >0.05).",[],['Food Addiction Explanation Model'],"[""dislike of 'fat people' stigma measure"", 'weight stigma', ""dislike of 'fat people"", 'personal willpower weight stigma', 'weight stigma scores', 'Weight Control and Obesity on Weight Stigma']",[],"[{'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0160045,"Participants receiving the diet and exercise explanation had greater dislike of 'fat people' than those in the FAM explanation and control group ( p  values < 0.05), with no difference between the FAM and control groups ( p  >0.05).","[{'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'School of Social Sciences, Faculty of Arts, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Puhl', 'Affiliation': 'Department of Human Development and Family Sciences, Rudd Center for Food Policy & Obesity, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Latner', 'Affiliation': 'Department of Psychology, College of Social Sciences, University of Hawaii, Manoa, HI 96822, USA.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Lynott', 'Affiliation': 'Department of Psychology, Faculty of Science and Technology University of Lancaster, Lancaster LA1 4YW, UK.'}, {'ForeName': 'Jessica D', 'Initials': 'JD', 'LastName': 'Reid', 'Affiliation': 'School of Social Sciences, Faculty of Arts, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'Zarina', 'Initials': 'Z', 'LastName': 'Vakhitova', 'Affiliation': 'School of Social Sciences, Faculty of Arts, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Hunter', 'Affiliation': 'Division of Sciences, Department of Psychology, University of Otago, Dunedin 9016, New Zealand.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Scarf', 'Affiliation': 'Division of Sciences, Department of Psychology, University of Otago, Dunedin 9016, New Zealand.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Jeanes', 'Affiliation': 'Curriculum & Pedagogy, Faculty of Education, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Bouguettaya', 'Affiliation': 'School of Social Sciences, Faculty of Arts, Monash University, Melbourne 3800, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Carter', 'Affiliation': 'School of Psychology, Faculty of Medicine, Nursing, and Health Sciences, Monash University, Melbourne 3800, Australia.'}]",Nutrients,['10.3390/nu12020294']
2138,32015415,"Stratifying cellular metabolism during weight loss: an interplay of metabolism, metabolic flexibility and inflammation.","Obesity is a global epidemic, contributing significantly to chronic non-communicable diseases, such as type 2 diabetes mellitus, cardiovascular diseases and metabolic syndrome. Metabolic flexibility, the ability of organisms to switch between metabolic substrates, is found to be impaired in obesity, possibly contributing to the development of chronic illnesses. Several studies have shown the improvement of metabolic flexibility after weight loss. In this study, we have mapped the cellular metabolism of the adipose tissue from a weight loss study to stratify the cellular metabolic processes and metabolic flexibility during weight loss. We have found that for a majority of the individuals, cellular metabolism was downregulated during weight loss, with gene expression of all major cellular metabolic processes (such as glycolysis, fatty acid β-oxidation etc.) being lowered during weight loss and weight maintenance. Parallel to this, the gene expression of immune system related processes involving interferons and interleukins increased. Previously, studies have indicated both negative and positive effects of post-weight loss inflammation in the adipose tissue with regards to weight loss or obesity and its co-morbidities; however, mechanistic links need to be constructed in order to determine the effects further. Our study contributes towards this goal by mapping the changes in gene expression across the weight loss study and indicates possible cross-talk between cellular metabolism and inflammation.",2020,"Parallel to this, the gene expression of immune system related processes involving interferons and interleukins increased.",[],[],"['metabolic flexibility', 'Metabolic flexibility']",[],[],"[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",,0.0213243,"Parallel to this, the gene expression of immune system related processes involving interferons and interleukins increased.","[{'ForeName': 'Samar H K', 'Initials': 'SHK', 'LastName': 'Tareen', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, The Netherlands. samar.tareen@gmail.com.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kutmon', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Theo M', 'Initials': 'TM', 'LastName': 'de Kok', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Edwin C M', 'Initials': 'ECM', 'LastName': 'Mariman', 'Affiliation': 'Department of Human Biology, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Marleen A', 'Initials': 'MA', 'LastName': 'van Baak', 'Affiliation': 'Department of Human Biology, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Chris T', 'Initials': 'CT', 'LastName': 'Evelo', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Michiel E', 'Initials': 'ME', 'LastName': 'Adriaens', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Ilja C W', 'Initials': 'ICW', 'LastName': 'Arts', 'Affiliation': 'Maastricht Centre for Systems Biology (MaCSBio), Maastricht University, Maastricht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-58358-z']
2139,32066784,Correlation of age-of-onset of Atopic Dermatitis with Filaggrin loss-of-function variant status.,"The genetic background of Atopic Dermatitis (AD) with chronic pruritus is complex. Filaggrin (FLG) is an essential gene in the epidermal barrier formation s. Loss-of-function (LOF) variants in FLG associated with skin barrier dysfunction constitute the most well-known genetic risk factor for AD. In this study, we focused on the frequency and effect of FLG loss-of-function variants in association with self-reported age-of-onset of AD. The dataset consisted of 386 whole-genome sequencing (WGS) samples. We observe a significant association between FLG LOF status and age-of-onset, with earlier age of onset of AD observed in the FLG LOF carrier group (p-value 0.0003, Wilcoxon two-sample test). We first tested this on the two most prevalent FLG variants. Interestingly, the effect is even stronger when considering all detected FLG LOF variants. Having two or more FLG LOF variants associates with the onset of AD at 2 years of age. In this study, we have shown enrichment of rare variants in the EDC region in cases compared with controls. Age-of-onset analysis shows not only the effect of the FLG and likely EDC variants in terms of the heightened risk of AD, but foremost enables to predict early-onset, lending further credence to the penetrance and causative effect of the identified variants. Understanding the genetic background and risk of early-onset is suggestive of skin barrier dysfunction etiology of AD with chronic pruritus.",2020,Filaggrin (FLG) is an essential gene in the epidermal barrier formation s.,['Atopic Dermatitis with Filaggrin loss-of-function variant status'],"['FLG', 'Filaggrin (FLG']",['FLG LOF status and age-of-onset'],"[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0117738', 'cui_str': 'filaggrin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0117738', 'cui_str': 'filaggrin'}]","[{'cui': 'C0117738', 'cui_str': 'filaggrin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",386.0,0.0296545,Filaggrin (FLG) is an essential gene in the epidermal barrier formation s.,"[{'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Smieszek', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA. Sandra.Smieszek@vandapharma.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Welsh', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Birznieks', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals Inc., Washington, DC, USA.'}]",Scientific reports,['10.1038/s41598-020-59627-7']
2140,33201596,Adverse Effects of Low-Dose Methotrexate in a Randomized Double-Blind Placebo-Controlled Trial: Adjudicated Hematologic and Skin Cancer Outcomes in the Cardiovascular Inflammation Reduction Trial.,"OBJECTIVE


Low-dose methotrexate (LD-MTX), a cornerstone in the treatment of rheumatoid arthritis, is associated with a moderately increased risk of anemia, leukopenia, and skin cancers, but the risks of myelosuppression and malignancy during LD-MTX use remain incompletely described. We examined the risks of cytopenias and skin cancers among patients taking LD-MTX versus placebo in a large randomized controlled trial (RCT).
METHODS


We prespecified secondary analyses of a double-blind, placebo-controlled RCT that included adults with known cardiovascular disease and diabetes or metabolic syndrome in the United States and Canada. Subjects were randomly allocated to LD-MTX (20 mg/week maximum) or placebo. All subjects received folic acid (1 mg daily for 6days/week). We assessed the frequency of blindly adjudicated hematologic and malignant adverse events (AEs).
RESULTS


A total of 2391 subjects were randomized to LD-MTX (mean dosage 14.9 mg/week), and 2395 were randomized to placebo. During follow-up, in the LD-MTX arm, simultaneous two-line cytopenias (n = 92 [3.9%]) or pancytopenia (n = 13 [0.54%]) were infrequent. Pancytopenia developed as soon as 4 months and as late as 3.5 years after beginning LD-MTX, though the latter subject had been recently diagnosed with multiple myeloma. Overall skin cancer risk was increased in users of LD-MTX compared with users of placebo, which driven largely by a statistically significant increased risk of squamous cell skin cancer (hazard ratio [HR] 3.31; 95% confidence interval [CI] 1.63-6.71). Melanoma was increased in LD-MTX, but this was not statistically significant (HR 2.33; 95% CI 0.60-9.01).
CONCLUSIONS


Among subjects using LD-MTX, simultaneous two-line cytopenias and pancytopenia were uncommon. We found more cases of skin cancer, particularly squamous cell carcinomas, in the LD-MTX arm than the placebo arm.",2020,"We found more cases of skin cancer, particularly squamous cell carcinomas, in the LD-MTX arm than the placebo arm.","['patients taking LD', 'A total of 2391 subjects', 'adults with known cardiovascular disease and diabetes or metabolic syndrome in the United States and Canada']","['methotrexate (LD-MTX', 'folic acid', 'MTX versus placebo', 'placebo', 'placebo-controlled RCT', 'Low-Dose Methotrexate', 'Placebo', 'LD-MTX']","['risks of cytopenias and skin cancers', 'risk of squamous cell skin cancer', 'Overall skin cancer risk', 'frequency of blindly adjudicated hematologic and malignant adverse events (AEs', 'Melanoma']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010828', 'cui_str': 'Cytopenia'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]",2391.0,0.687506,"We found more cases of skin cancer, particularly squamous cell carcinomas, in the LD-MTX arm than the placebo arm.","[{'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}]",ACR open rheumatology,['10.1002/acr2.11187']
2141,33201625,[Nabiximols as a substitute for cannabis].,"Cannabis addiction is worldwide one of the most prevalent addictions, without any effective pharmacotherapeutic options. Nabiximols spray, consisting of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), could serve as an effective substitution therapy for cannabis addiction. Researchers reported that patients who were treated for 12 weeks with nabiximols significantly reduced the number of days on which they used cannabis (18.6 days less compared to placebo users; 95% CI: 3.5-33.7). There was no difference between groups regarding general health, the use of other substances, cannabis craving, withdrawal symptoms or achieving abstinence.",2020,"There was no difference between groups regarding general health, the use of other substances, cannabis craving, withdrawal symptoms or achieving abstinence.",[],"['Nabiximols spray, consisting of 2.7 mg tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD']","['general health, the use of other substances, cannabis craving, withdrawal symptoms or achieving abstinence', 'number of days on which they used cannabis']",[],"[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.175284,"There was no difference between groups regarding general health, the use of other substances, cannabis craving, withdrawal symptoms or achieving abstinence.","[{'ForeName': 'G J H', 'Initials': 'GJH', 'LastName': 'Dumont', 'Affiliation': 'Amsterdam UMC, locatie AMC, ziekenhuisapotheek, Amsterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
2142,33196289,"Beneficial Effects of Paraffin Bath Therapy as Additional Treatment of Chronic Hand Eczema: A Randomized, Single-Blind, Active-Controlled, Parallel-Group Study.","Objective:  Chronic hand eczema (CHE) is a common inflammatory skin disease with a major psychological and socioeconomic impacts on patients' quality of life (QoL) and work ability. To the best of knowledge, this study is the first randomized-controlled trial conducted to evaluate the effect of paraffin bath therapy in management of hand eczema and its related symptoms.  Design:  This study was a parallel-group, active-control, randomized clinical trial with measures at pretreatment, 6th week, and 12th week of treatment.  Settings:  The study took place at the Outpatient Clinic of Faculty of Physical Therapy, Cairo University, and some licensed rehabilitation centers in Cairo for a 1-year period.  Subjects:  Sixty patients with moderate to severe CHE were randomly assigned into two groups of equal number; the paraffin bath therapy group and the control group.  Interventions:  The paraffin group received paraffin bath therapy for 5 days a week for 12 weeks, in addition to the routine skin care program, while the control group only received the routine skin care program.  Outcome measures:  SCORing Atopic Dermatitis (SCORAD) was used to assess the severity of atopic dermatitis and dermatology life quality index (DLQI) to assess the effect of CHE on quality of patients' life. All measurements were obtained before, at the 6th week, and at the 12th week of treatment.  Results:  Marked improvement in the severity of the disease symptoms was observed, reflected by a highly decrease in objective SCORAD score in the paraffin group over time more than the control group. The percentage of reduction was 28.6% in paraffin group versus 0.41% in control group. Subjective item score (itching and sleepiness) was reduced in the paraffin group more than the control group with a percentage of improvement (47% and 5.5%), respectively. Regarding QoL measure, there were highly positive changes in DLQI in paraffin group more than the control group. The percentage of improvement was 60% in paraffin group and 3.8% in control group.  Conclusions:  Paraffin bath therapy applied for a 12-week duration seems to be effective, both in reducing severity of eczema symptoms and improving QoL in patients with CHE.",2020,"Subjective item score (itching and sleepiness) was reduced in the paraffin group more than the control group with a percentage of improvement (47% and 5.5%), respectively.","['Subjects:  Sixty patients with moderate to severe CHE', 'Outpatient Clinic of Faculty of Physical Therapy, Cairo University, and some licensed rehabilitation centers in Cairo for a 1-year period', 'Chronic Hand Eczema', 'patients with CHE']","['Chronic hand eczema (CHE', 'paraffin bath therapy', 'paraffin bath therapy group and the control group', 'Paraffin bath therapy', 'routine skin care program', 'Paraffin Bath Therapy', 'paraffin', 'CHE']","['objective SCORAD score', 'Outcome measures:  SCORing Atopic Dermatitis (SCORAD', 'severity of atopic dermatitis and dermatology life quality index (DLQI', 'percentage of reduction', ""quality of patients' life"", 'severity of the disease symptoms', 'Subjective item score (itching and sleepiness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1276092', 'cui_str': 'Chronic hand eczema'}]","[{'cui': 'C1276092', 'cui_str': 'Chronic hand eczema'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C1504484', 'cui_str': 'Bath therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",60.0,0.033179,"Subjective item score (itching and sleepiness) was reduced in the paraffin group more than the control group with a percentage of improvement (47% and 5.5%), respectively.","[{'ForeName': 'Intsar S', 'Initials': 'IS', 'LastName': 'Waked', 'Affiliation': 'Professor at Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Zizi M', 'Initials': 'ZM', 'LastName': 'Ibrahim', 'Affiliation': 'Associate Professor at Rehabilitation Sciences Department, College of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Kingdom of Saudi Arabia.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0356']
2143,33196485,"Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial).","OBJECTIVE


To establish the optimal time to start oral refeeding in mild and moderate acute pancreatitis (AP) to reduce hospital length-of-stay (LOS) and complications.
SUMMARY BACKGROUND DATA


Oral diet is essential in mild and moderate AP. The greatest benefits are obtained if refeeding starts early; however, the definition of ""early"" remains controversial.
METHODS


This multicenter, randomized, controlled trial (NCT03829085) included patients with a diagnosis of mild or moderate AP admitted consecutively to 4 hospitals from 2017 to 2019. Patients were randomized into 2 treatment groups: immediate oral refeeding (IORF) and conventional oral refeeding (CORF). The IORF group (low-fat-solid diet initiated immediately after hospital admission) was compared to CORF group (progressive oral diet was restarted when clinical and laboratory parameters had improved) in terms of LOS (primary endpoint), pain relapse, diet intolerance, complications, and, hospital costs.
RESULTS


One hundred-thirty-three patients were included for randomization. The mean LOS for the IORF and CORF groups was 3.4 (SD ± 1.7) and 8.8 (SD ± 7.9) days, respectively (P < 0.001). In the CORF group alone, pain relapse rate was 16%. There were fewer complications (8% vs 26%) and health costs were twice as low, with a savings of 1325.7&OV0556;/patient in the IORF than CORF group.
CONCLUSIONS


IORF is safe and feasible in mild and moderate AP, resulting in significantly shorter LOS and cost savings, without causing adverse effects or complications.",2020,"There were fewer complications (8% vs 26%) and health costs were twice as low, with a savings of 1325.7&OV0556;/patient in the IORF than CORF group.
","['patients with a diagnosis of mild or moderate AP admitted consecutively to 4 hospitals from 2017 to 2019', 'Patients With Mild and Moderate Acute Pancreatitis', 'mild and moderate acute pancreatitis (AP', 'One hundred-thirty-three patients were included for randomization']","['IORF', 'immediate oral refeeding (IORF) and conventional oral refeeding (CORF', 'CORF']","['health costs', 'pain relapse rate', 'pain relapse, diet intolerance, complications, and, hospital costs', 'LOS and cost savings', 'mean LOS', 'complications', 'hospital length-of-stay (LOS) and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",133.0,0.112744,"There were fewer complications (8% vs 26%) and health costs were twice as low, with a savings of 1325.7&OV0556;/patient in the IORF than CORF group.
","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ramírez-Maldonado', 'Affiliation': 'General and Digestive Surgery Department, Consorci Sanitari Garraf, Sant Pere de Ribes, Barcelona, Spain.'}, {'ForeName': 'Sandra López', 'Initials': 'SL', 'LastName': 'Gordo', 'Affiliation': 'General and Digestive Surgery Department, Consorci Sanitari Garraf, Sant Pere de Ribes, Barcelona, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Pueyo', 'Affiliation': 'General and Digestive Surgery Department, Moisès Broggi Hospital, CSI, Barcelona, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Sánchez-García', 'Affiliation': 'Gastroenterology Department, Hospital Clinic, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Mayol', 'Affiliation': 'General and Digestive Surgery Department, Consorci Sanitari Garraf, Sant Pere de Ribes, Barcelona, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'González', 'Affiliation': 'General and Digestive Surgery Department, Moisès Broggi Hospital, CSI, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Elvira', 'Affiliation': 'General and Digestive Surgery Department, University Hospital of Tarragona Joan XXIII, Rovira i Virgili University, Tarragona, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Memba', 'Affiliation': 'General and Digestive Surgery Department, University Hospital of Tarragona Joan XXIII, Rovira i Virgili University, Tarragona, Spain.'}, {'ForeName': 'Constantino', 'Initials': 'C', 'LastName': 'Fondevila', 'Affiliation': 'General and Digestive Surgery Department, Hospital Clínic, IDIBAPS, CIBEREHD, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Jorba', 'Affiliation': 'General and Digestive Surgery Department, University Hospital of Tarragona Joan XXIII, Rovira i Virgili University, Tarragona, Spain.'}]",Annals of surgery,['10.1097/SLA.0000000000004596']
2144,33196511,A pilot randomized trial of atorvastatin as adjunct therapy in patients with acute venous thromboembolism.,": Venous thromboembolism (VTE) is the third most common cardiovascular disease and optimizing treatment is essential. In this single-center pilot study, we sought to investigate the effects of statins in addition to anticoagulation in patients with acute VTE. We enrolled patients over 18 with an acute proximal lower extremity deep vein thrombosis with or without pulmonary embolism. Patients were randomized to anticoagulation alone (with either warfarin or rivaroxaban) or anticoagulation and atorvastatin 40 mg daily and followed for 9 months. The primary objective was to determine if adjunct atorvastatin reduced thrombin generation, measured by endogenous thrombin potential and/or peak thrombin concentration. Secondary endpoints included recurrent VTE, arterial thrombosis, bleeding events, lipidomic profiles, and symptoms of post thrombotic syndrome. A total of 21 patients were enrolled (11 anticoagulation only and 10 anticoagulation and atorvastatin) over 3.5 years. Endogenous thrombin potential or peak thrombin was not significantly recued with the addition of atorvastatin. Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either D-dimer or high-sensitivity-C reactive protein. Given the low recruitment rate, continuation of the study was deemed futile and the study was terminated early. Barriers to enrollment and completion of study included the many ineligible patients by exclusion criteria (e.g., preexisting statin use, active malignancy, etc.) and high rate of lost follow-up. The pilot study was terminated early but could inform obstacles for future studies investigating the effects of statins in the management of patients with VTE.",2020,"Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either D-dimer or high-sensitivity-C reactive protein.","['patients with acute venous thromboembolism', 'enrolled patients over 18 with an acute proximal lower extremity deep vein thrombosis with or without pulmonary embolism', 'many ineligible patients by exclusion criteria (e.g., preexisting statin use, active malignancy, etc.) and high rate of lost follow-up', 'patients with acute VTE', 'patients with VTE', '21 patients were enrolled (11 anticoagulation only and 10 anticoagulation and atorvastatin) over 3.5 years']","['statins', 'anticoagulation alone (with either warfarin or rivaroxaban) or anticoagulation and atorvastatin', 'Atorvastatin', 'atorvastatin']","['endogenous thrombin potential and/or peak thrombin concentration', 'mean LDLs', 'Endogenous thrombin potential or peak thrombin', 'recurrent VTE, arterial thrombosis, bleeding events, lipidomic profiles, and symptoms of post thrombotic syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0277919', 'cui_str': 'Venous stasis syndrome'}]",21.0,0.046449,"Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either D-dimer or high-sensitivity-C reactive protein.","[{'ForeName': 'Tzu-Fei', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Amanda P', 'Initials': 'AP', 'LastName': 'Waller', 'Affiliation': ""Center for Clinical & Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital.""}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Lin', 'Affiliation': 'College of Food, Agriculture, and Environmental Sciences.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Center for Biostatistics, The Ohio State University.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Bartosic', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Riedl', 'Affiliation': 'College of Food, Agriculture, and Environmental Sciences.'}, {'ForeName': 'Bryce A', 'Initials': 'BA', 'LastName': 'Kerlin', 'Affiliation': ""Center for Clinical & Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital.""}]",Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis,['10.1097/MBC.0000000000000968']
2145,33196555,"COVID-19 Related Medical Mistrust, Health Impacts, and Potential Vaccine Hesitancy Among Black Americans Living with HIV.","BACKGROUND


Medical mistrust, a result of systemic racism, is prevalent among Black Americans and may play a role in COVID-19 inequities. In a convenience sample of HIV-positive Black Americans, we examined associations of COVID-19 related medical mistrust with COVID-19 vaccine and COVID-19 treatment hesitancy, and negative impacts of COVID-19 on antiretroviral therapy (ART) adherence.
METHODS


Participants were 101 HIV-positive Black Americans (age: M=50.3 years; SD=11.5; 86% cisgender male; 77% sexual minority) enrolled in a randomized controlled trial of a community-based ART adherence intervention in Los Angeles County, CA. From May to July 2020, participants completed telephone interviews on negative COVID-19 impacts, general COVID-19 mistrust (e.g., about the government withholding information), COVID-19 vaccine and treatment hesitancy, and trust in COVID-19 information sources. Adherence was monitored electronically with the Medication Events Monitoring System.
RESULTS


Nearly all participants (97%) endorsed at least one general COVID-19 mistrust belief, and over half endorsed at least one COVID-19 vaccine or treatment hesitancy belief. Social service and healthcare providers were the most trusted sources. Greater COVID-19 mistrust was related to greater vaccine and treatment hesitancy [b (SE)=0.85 (0.14), p<.0001 and b (SE)=0.88 (0.14), p<.0001, respectively]. Participants experiencing more negative COVID-19 impacts showed lower ART adherence, assessed among a subset of 49 participants [b (SE) = -5.19 (2.08), p = .02].
DISCUSSION


To prevent widening health inequities, healthcare providers should engage with communities to tailor strategies to overcome mistrust and deliver evidence-based information, in order to encourage COVID-19 vaccine and treatment uptake.",2020,"Greater COVID-19 mistrust was related to greater vaccine and treatment hesitancy [b (SE)=0.85 (0.14), p<.0001 and b (SE)=0.88 (0.14), p<.0001, respectively].","['convenience sample of HIV-positive Black Americans', 'Participants were 101 HIV-positive Black Americans (age: M=50.3 years; SD=11.5; 86% cisgender male; 77% sexual minority', 'Black Americans', 'Black Americans Living with HIV']",['community-based ART adherence intervention'],"['COVID-19 Related Medical Mistrust, Health Impacts, and Potential Vaccine Hesitancy', 'ART adherence']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C3886636', 'cui_str': 'AM-101'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.184576,"Greater COVID-19 mistrust was related to greater vaccine and treatment hesitancy [b (SE)=0.85 (0.14), p<.0001 and b (SE)=0.88 (0.14), p<.0001, respectively].","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bogart', 'Affiliation': 'RAND Corporation.'}, {'ForeName': 'Bisola O', 'Initials': 'BO', 'LastName': 'Ojikutu', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital.""}, {'ForeName': 'Keshav', 'Initials': 'K', 'LastName': 'Tyagi', 'Affiliation': 'Community-Based Research, APLA Health & Wellness.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation.'}, {'ForeName': 'Matt G', 'Initials': 'MG', 'LastName': 'Mutchler', 'Affiliation': 'Community-Based Research, APLA Health & Wellness.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'RAND Corporation.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Lawrence', 'Affiliation': 'Community-Based Research, APLA Health & Wellness.'}, {'ForeName': 'Damone', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Community-Based Research, APLA Health & Wellness.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kellman', 'Affiliation': 'Community-Based Research, APLA Health & Wellness.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002570']
2146,33196559,The Effect of Using Eye Masks and Earplugs on Intensive Care Patients Quality of Sleep and Vital Signs.,"BACKGROUND


Intensive care unit (ICU) patients with severe health problems experience a high rate of sleep deprivation that harms their psychological and physiological health. Environmental factors are considered to be the greatest cause of sleep deprivation in the ICU, and noise and light are leading among these factors. This study aimed to investigate the effect of eye masks and earplugs on the sleep quality and vital signs of conscious ICU patients.
METHODS


This study used a quasi-experimental, in similar groups, pretest-posttest design with a control group. The Richards-Campbell Sleep Questionnaire (RCSQ) was used to collect data, and vital signs were recorded every 2 hours. On day 1, standard care was provided to the experimental group (n = 32), and they were provided with eye masks and earplugs on day 2. The control group (n = 32) was provided with standard care on both days. Chi-square, t, and McNemar and McNemar-Bowker tests were used to analyze the data. Multiple regression analysis was used for predictive analysis.
RESULTS


The RCSQ mean (SD) pretest and posttest scores were 50.21 (16.02) and 68.50 (17.57), respectively, for the experimental group and 55.34 (16.62) and 49.03 (15.53), respectively, for the control group. In the experimental group, the posttest RCSQ score was significantly higher than the pretest RCSQ score (P < .01). No differences in vital signs were observed in the control group. All the vital signs were found to be similar in the experimental group, except for the mean daily pulse rate.
CONCLUSION


The use of earplugs and eye masks may help reduce sleep deprivation. Eye masks and earplugs can be used by nurses to improve the sleep quality of patients in ICUs.",2020,"In the experimental group, the posttest RCSQ score was significantly higher than the pretest RCSQ score (P < .01).","['ICU) patients with severe health problems experience', 'conscious ICU patients', 'Intensive care unit ']","['eye masks and earplugs', 'earplugs and eye masks', 'Eye Masks and Earplugs']","['mean daily pulse rate', 'sleep deprivation', 'RCSQ mean (SD) pretest and posttest scores', 'Richards-Campbell Sleep Questionnaire (RCSQ', 'sleep quality and vital signs', 'vital signs', 'Intensive Care Patients Quality of Sleep and Vital Signs', 'posttest RCSQ score', 'sleep quality']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0181752', 'cui_str': 'Eye mask'}, {'cui': 'C1135964', 'cui_str': 'Ear plug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",32.0,0.0227409,"In the experimental group, the posttest RCSQ score was significantly higher than the pretest RCSQ score (P < .01).","[{'ForeName': 'Ayyüce Tuba', 'Initials': 'AT', 'LastName': 'Koçak', 'Affiliation': 'Questions or comments about this article may be directed to Ayyüce Tuba Koçak, MSc, at ayyuce_akdeniz14@outlook.com. A.T.K. is a Research Assistant and a PhD Student, Nursing Faculty, Selcuk University, Konya, Turkey. Selda Arslan, PhD, is PhD Instructor, Nursing Faculty, Department of Internal Medicine Nursing, Necmettin Erbakan University, Konya, Turkey.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000562']
2147,33124686,Regulation of plasma volume in male lowlanders during 4 days of exposure to hypobaric hypoxia equivalent to 3500 m altitude.,"KEY POINTS


Acclimatization to hypoxia leads to a reduction in plasma volume (PV) that restores arterial O 2  content. Findings from studies investigating the mechanisms underlying this PV contraction have been controversial, possibly as experimental conditions were inadequately controlled. We examined the mechanisms underlying the PV contraction evoked by 4 days of exposure to hypobaric hypoxia (HH) in 11 healthy lowlanders, while strictly controlling water intake, diet, temperature and physical activity. Exposure to HH-induced an ∼10% PV contraction that was accompanied by a reduction in total circulating protein mass, whereas diuretic fluid loss and total body water remained unchanged. Our data support an oncotically driven fluid redistribution from the intra- to the extravascular space, rather than fluid loss, as the mechanism underlying HH-induced PV contraction.
ABSTRACT


Extended hypoxic exposure reduces plasma volume (PV). The mechanisms underlying this effect are controversial, possibly as previous studies have been confounded by inconsistent experimental conditions. Here, we investigated the effect of hypobaric hypoxia (HH) on PV in a cross-over study that strictly controlled for diet, water intake, physical activity and temperature. Eleven males completed two 4-day sojourns in a hypobaric chamber, one in normoxia (NX) and one in HH equivalent to 3500 m altitude. PV, urine output, volume-regulating hormones and plasma protein concentration were determined daily. Total body water (TBW) was determined at the end of both sojourns by deuterium dilution. Although PV was 8.1 ± 5.8% lower in HH than in NX after 24 h and remained ∼10% lower thereafter (all P < 0.002), no differences were detected in TBW (P = 0.17) or in 24 h urine volumes (all P > 0.23). Plasma renin activity and circulating aldosterone were suppressed in HH during the first half of the sojourn (all P < 0.05) but thereafter similar to NX, whereas no differences were detected for copeptin between sojourns (all P > 0.05). Markers for atrial natriuretic peptide were higher in HH than NX after 30 min (P = 0.001) but lower during the last 2 days (P < 0.001). While plasma protein concentration was similar between sojourns, total circulating protein mass (TCP) was reduced in HH at the same time points as PV (all P < 0.03). Despite transient hormonal changes favouring increased diuresis, HH did not enhance urine output. Instead, the maintained TBW and reduced TCP support an oncotically driven fluid redistribution into the extravascular compartment as the mechanism underlying PV contraction.",2020,Markers for atrial natriuretic peptide were higher in HH than NX after 30 min (P = 0.001) but lower during the last 2 days (P < 0.001).,"['male lowlanders during 4 days of exposure to hypobaric hypoxia equivalent to 3500\xa0m altitude', '11 healthy lowlanders', 'Eleven males completed two 4-day sojourns in a hypobaric chamber, one in normoxia (NX) and one in HH equivalent to 3500\xa0m altitude']","['hypobaric hypoxia (HH', 'PV contraction evoked by 4 days of exposure to hypobaric hypoxia (HH']","['Total body water (TBW', 'TBW', 'diuretic fluid loss and total body water', 'total circulating protein mass (TCP', 'total circulating protein mass', 'plasma volume (PV', 'Plasma renin activity and circulating aldosterone', 'PV, urine output, volume-regulating hormones and plasma protein concentration', 'atrial natriuretic peptide', 'plasma protein concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1964473', 'cui_str': 'Sojourn'}, {'cui': 'C0179879', 'cui_str': 'Hypobaric chamber'}]","[{'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0235395', 'cui_str': 'Fluid loss'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}]",,0.0178921,Markers for atrial natriuretic peptide were higher in HH than NX after 30 min (P = 0.001) but lower during the last 2 days (P < 0.001).,"[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Schlittler', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}, {'ForeName': 'Ivo B', 'Initials': 'IB', 'LastName': 'Regli', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Woyke', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Strapazzon', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rasmussen', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kob', 'Affiliation': 'Division of Clinical Nutrition, Bolzano Regional Hospital, Bolzano, Italy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Pathology, Hospital of Bolzano, Bolzano, Italy.'}, {'ForeName': 'Jens P', 'Initials': 'JP', 'LastName': 'Goetze', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Maillard', 'Affiliation': 'Service of Nephrology, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Feraille', 'Affiliation': 'National Center of Competence in Research Kidney Control of Homeostasis (Kidney.CH), Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Siebenmann', 'Affiliation': 'Institute of Mountain Emergency Medicine, EURAC Research, Bolzano, Italy.'}]",The Journal of physiology,['10.1113/JP280601']
2148,32096138,A novel scoliosis instrumentation using special superelastic nickel-titanium shape memory rods: a biomechanical analysis using a calibrated computer model and data from a clinical trial.,"STUDY DESIGN


Biomechanical analysis of scoliosis instrumentation using superelastic Nickel-titanium shape memory (SNT) rods.
OBJECTIVE


To compare SNT with conventional Titanium (Ti) and Cobalt-chrome (Co-Cr) rods. A clinical trial has documented comparable efficacy between two adolescent idiopathic scoliosis (AIS) cohorts instrumented using SNT versus conventional Ti rods. The shape memory and superelasticity of the SNT rod are thought to allow easy rod insertion, progressive curve correction, and correction from spinal tissue relaxation, but study is yet to be done to assess the effects of the shape memory and superelasticity.
METHODS


Instrumentations of AIS patients from the clinical trial were computationally simulated using SNT, Ti and Co-Cr rods (5.5 or 6 mm; 30°, 50° or 60° sagittal contouring angles; 0°, 25° or 50° coronal over-contouring angles). Curve correction, its improvement from stress relaxation in the spine, and loads in the instrumentation constructs were computed and compared.
RESULTS


The simulated main thoracic Cobb angles (MT) and thoracic kyphosis with the SNT rods were 4°-7° higher and 1°-2° lower than the Ti and Co-Cr rods, respectively. Bone-implant forces with Ti and Co-Cr rods were higher than the SNT rods by 84% and 130% at 18 °C and 35% and 65% at 37 °C, respectively (p < 0.001). Further corrections of the MT from the simulated stress relaxation in the spine were 4°-8° with the SNT rods versus 2°-5° with the Ti and Co-Cr rods (p < 0.001).
CONCLUSION


This study concurs with clinical observation that the SNT rods are easier to insert and can result in similar correction to the conventional rods. The SNT rods allow significantly lower bone-implant forces and have the ability to take advantage of post-instrumentation correction as the tissues relax.",2020,Bone-implant forces with Ti and Co-Cr rods were higher than the SNT rods by 84% and 130% at 18 °C and 35% and 65% at 37 ,"['Instrumentations of AIS patients from the clinical trial were computationally simulated using SNT, Ti and Co-Cr rods (5.5 or 6\xa0mm; 30°, 50° or 60° sagittal contouring angles; 0°, 25° or 50° coronal over-contouring angles']","['special superelastic nickel-titanium shape memory rods', 'SNT versus conventional Ti rods', 'SNT rods versus 2°-5', 'superelastic Nickel-titanium shape memory (SNT', 'SNT with conventional Titanium (Ti) and Cobalt-chrome (Co-Cr) rods']",[],"[{'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0008576', 'cui_str': 'Cobalt-chromium alloy'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0008576', 'cui_str': 'Cobalt-chromium alloy'}]",[],,0.0306989,Bone-implant forces with Ti and Co-Cr rods were higher than the SNT rods by 84% and 130% at 18 °C and 35% and 65% at 37 ,"[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Mechanical Engineering, Polytechnique Montreal, Downtown Station, P.O. Box 6079, Montreal, QC, H3C 3A7, Canada.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Yeung', 'Affiliation': 'Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jason Pui Yin', 'Initials': 'JPY', 'LastName': 'Cheung', 'Affiliation': 'Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Johnson Yiu-Nam', 'Initials': 'JY', 'LastName': 'Lau', 'Affiliation': 'Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Weichen', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kenneth Man-Chee', 'Initials': 'KM', 'LastName': 'Cheung', 'Affiliation': 'Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong SAR, China. cheungmc@hku.hk.'}, {'ForeName': 'Carl-Eric', 'Initials': 'CE', 'LastName': 'Aubin', 'Affiliation': 'Department of Mechanical Engineering, Polytechnique Montreal, Downtown Station, P.O. Box 6079, Montreal, QC, H3C 3A7, Canada. carl-eric.aubin@polymtl.ca.'}]",Spine deformity,['10.1007/s43390-020-00075-8']
2149,32164728,Evaluating implementation effectiveness and sustainability of a maternity waiting homes intervention to improve access to safe delivery in rural Zambia: a mixed-methods protocol.,"BACKGROUND


In low-income countries such as Zambia, where maternal mortality rates are persistently high, maternity waiting homes (MWHs) represent one potential strategy to improve access to safe delivery, especially for women living in remote areas. The Maternity Homes Access in Zambia project (MAHMAZ) is evaluating the impact of a MWH model on women's access to safe delivery in rural Zambia. There is a growing need to understand not only the effectiveness of interventions but also the effectiveness of their implementation in order to appropriately interpret outcomes. There is little evidence to guide effective implementation of MWH for both immediate uptake and to promote sustainability in this context. This protocol describes a study that aims to investigate the effectiveness of the implementation of MAHMAZ by not only documenting fidelity but also identifying factors that influence implementation success and affect longer-term sustainability.
METHODS


This study will use mixed methods to evaluate the implementation effectiveness and sustainability of the MAHMAZ intervention. In our study, ""implementation effectiveness"" means to expand beyond measuring fidelity to the MWH model and includes assessing both the adoption and uptake of the model and identifying those factors that facilitate or inhibit uptake. Sustainability is defined as the routine implementation of an intervention after external support has ended. Quantitative methods include extracting data from existing records at the MWHs and health facilities to analyze patterns of utilization, and conducting a routine health facility assessment to determine facility-level factors that may influence MWH implementation and woman-level outcomes. We will also conduct an experience survey with MWH users and apply a checklist to assess fidelity to the MWH model. Qualitative methods include in-depth interviews and focus group discussions with MWH users, community members and other stakeholders. Qualitative data will be analyzed using an integrated framework drawing constructs from the Consolidated Framework for Implementation Research and the Conceptual Framework for Sustainability.
DISCUSSION


The findings from this evaluation will be shared with policymakers formulating policy affecting the implementation of MWH and may be used as evidence for programmatic decisions by the government and supporting agencies in deciding to take this model to scale.
TRIAL REGISTRATION


NCT02620436, Registered 3 December 2015, Prospectively registered (clinicaltrials.gov; for the overarching quasi-experimental impact study).",2020,The Maternity Homes Access in Zambia project (MAHMAZ) is evaluating the impact of a MWH model on women's access to safe delivery in rural Zambia.,"['rural Zambia', 'women living in remote areas']","['Zambia project (MAHMAZ', 'MAHMAZ intervention', 'MAHMAZ', 'maternity waiting homes intervention']",[],"[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0684333,The Maternity Homes Access in Zambia project (MAHMAZ) is evaluating the impact of a MWH model on women's access to safe delivery in rural Zambia.,"[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Henry', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Thandiwe', 'Initials': 'T', 'LastName': 'Ngoma', 'Affiliation': 'Right to Care-Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jeanette L', 'Initials': 'JL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Vian', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, 2130 Fulton Street, San Francisco, CA, 94117, USA.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Rockers', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Biemba', 'Affiliation': 'National Health Research Authority, Pediatric Centre of Excellence, Lusaka, Zambia.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown 3rd Floor, Boston, MA, 02118, USA. nscott@bu.edu.'}]",BMC health services research,['10.1186/s12913-020-4989-x']
2150,29781941,Cardiopulmonary Demand of 16-kg Kettlebell Snatches in Simulated Girevoy Sport.,"Chan, M, MacInnis, MJ, Koch, S, MacLeod, KE, Lohse, KR, Gallo, ME, Sheel, AW, and Koehle, MS. Cardiopulmonary demand of 16-kg kettlebell snatches in simulated Girevoy Sport. J Strength Cond Res 34(6): 1625-1633, 2020-Kettlebell lifting has become popular both as a strength and conditioning training tool and as a sport in and of itself: Girevoy Sport (GS). Although several kettlebell multimovement protocols have been analyzed, little research has attempted to quantify the aerobic stimulus of the individual events in GS, which could better inform kettlebell-related exercise prescription. The purpose of this study was to quantify the cardiopulmonary demand, assessed primarily by oxygen consumption (V[Combining Dot Above]O2) and heart rate (HR), of continuous high-intensity kettlebell snatches-under conditions relevant to GS-and to compare this demand with a more traditional graded rowing ergometer maximal exercise test. Ten male participants (age = 28.4 ± 4.6 years, height = 185 ± 7 cm, body mass = 95.1 ± 14.9 kg) completed (a) a graded-exercise test on a rowing ergometer to determine maximal oxygen consumption (V[Combining Dot Above]O2max) and maximal heart rate (HRmax) and (b) a graded-exercise test consisting of continuous 16-kg kettlebell snatches to determine peak oxygen consumption (V[Combining Dot Above]O2peak) and peak heart rate (HRpeak) during a simulated GS snatch event. Subjects achieved a V[Combining Dot Above]O2max of 45.7 ± 6.7 ml·kg·min and HRmax of 177 ± 8.3 b·min on the rowing ergometer. The kettlebell snatch test produced a V[Combining Dot Above]O2peak of 37.6 ± 4.4 ml·kg·min (82.7 ± 6.5% V[Combining Dot Above]O2max) and a HRpeak of 174 ± 10 b·min (98.0 ± 3.4% HRmax). These findings suggest that GS kettlebell snatches with 16-kg can provide an adequate aerobic stimulus to improve cardiorespiratory fitness in those with a V[Combining Dot Above]O2max of ≤51 ml·kg·min, according to aerobic training recommendations from the American College of Sports Medicine.",2020,Subjects achieved a V[Combining Dot Above]O2max of 45.7 ± 6.7 ml·kg·min and HRmax of 177 ± 8.3 b·min on the rowing ergometer.,"['J Strength Cond Res 34(6', 'Ten male participants (age = 28.4 ± 4.6 years, height = 185 ± 7 cm, body mass = 95.1 ± 14.9 kg) completed (a) a']","['V[Combining', 'traditional graded rowing ergometer maximal exercise test', 'graded-exercise test on a rowing ergometer to determine maximal oxygen consumption ']","['Chan, M, MacInnis, MJ, Koch, S, MacLeod, KE, Lohse, KR, Gallo, ME, Sheel, AW, and Koehle, MS', 'cardiorespiratory fitness', 'peak heart rate (HRpeak', 'peak oxygen consumption (V[Combining', 'oxygen consumption (V[Combining Dot Above]O2) and heart rate (HR', 'Dot Above]O2max) and maximal heart rate (HRmax']","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0264395', 'cui_str': 'Unilateral emphysema'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",10.0,0.0244246,Subjects achieved a V[Combining Dot Above]O2max of 45.7 ± 6.7 ml·kg·min and HRmax of 177 ± 8.3 b·min on the rowing ergometer.,"[{'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Chan', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'MacInnis', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'MacLeod', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Lohse', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Gallo', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'A William', 'Initials': 'AW', 'LastName': 'Sheel', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002588']
2151,33196606,Acute Running and Coronary Heart Disease Risk Markers in Male Cigarette Smokers and Nonsmokers: A Randomized Crossover Trial.,"PURPOSE


Cigarette smoking is an independent risk factor for coronary heart disease (CHD) and is associated with impaired postprandial metabolism. Acute exercise reduces postprandial lipemia and improves other CHD risk markers in non-smokers. Less is known about responses in cigarette smokers.
METHODS


Twelve male cigarette smokers (mean(SD) age 23(4) years, BMI 24.9(3.0) kg/m) and 12 male non-smokers (24(4) years, 24.1(2.0) kg/m) completed two, 2-day conditions (control, exercise) in a randomised, crossover design. On day 1, participants rested for 9-hours (08:00-17:00) in both conditions except a 60-minute treadmill run (65(7)% peak oxygen uptake, 2.87(0.54) MJ) was completed between 6.5-7.5 h (14:30-15:30) in the exercise condition. On day 2 of both conditions, participants rested and consumed two high-fat meals over 8-hours (09:00-17:00) during which 13 venous blood samples and nine resting arterial blood pressure measurements were taken.
RESULTS


Smokers exhibited higher postprandial triacylglycerol and C-reactive protein than non-smokers (main effect group effect size (Cohen's d)≥0.94, P≤0.034). Previous day running reduced postprandial triacylglycerol, insulin and systolic and diastolic blood pressure (main effect condition d≥0.28, P≤0.044), and elevated postprandial non-esterified fatty acid and C-reactive protein (main effect condition d≥0.41, P≤0.044). Group-by-condition interactions were not apparent for any outcome across the total postprandial period (0-8 h; all P≥0.089), but the exercise-induced reduction in postprandial triacylglycerol in the early postprandial period (0-4 h) was greater in non-smokers than smokers (-21% (d=0.43) vs -5% (d=0.16), respectively; group-by-condition interaction P=0.061).
CONCLUSIONS


Acute moderate-intensity running reduced postprandial triacylglycerol, insulin and resting arterial blood pressure the day after exercise in male cigarette smokers and non-smokers. These findings highlight the ability of acute exercise to augment the postprandial metabolic health of cigarette smokers and non-smokers.",2020,"RESULTS


Smokers exhibited higher postprandial triacylglycerol and C-reactive protein than non-smokers (main effect group effect size (Cohen's d)≥0.94, P≤0.034).","['age 23(4) years, BMI 24.9(3.0) kg/m) and 12 male non-smokers (24(4) years, 24.1(2.0) kg/m) completed two, 2-day conditions (control, exercise', 'male cigarette smokers and non-smokers', 'Male Cigarette Smokers and Nonsmokers', 'non-smokers', 'Twelve male cigarette smokers (mean(SD']","['Acute exercise', 'Acute Running and Coronary Heart Disease Risk Markers']","['postprandial metabolic health', 'postprandial triacylglycerol, insulin and systolic and diastolic blood pressure', 'postprandial triacylglycerol, insulin and resting arterial blood pressure', 'elevated postprandial non-esterified fatty acid and C-reactive protein', 'postprandial triacylglycerol', 'postprandial triacylglycerol and C-reactive protein', 'total postprandial period', 'CHD risk markers']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",12.0,0.0232111,"RESULTS


Smokers exhibited higher postprandial triacylglycerol and C-reactive protein than non-smokers (main effect group effect size (Cohen's d)≥0.94, P≤0.034).","[{'ForeName': 'Tareq F', 'Initials': 'TF', 'LastName': 'Alotaibi', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Roberts', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Turki M', 'Initials': 'TM', 'LastName': 'Alanazi', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Nicolette C', 'Initials': 'NC', 'LastName': 'Bishop', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Alex J', 'Initials': 'AJ', 'LastName': 'Wadley', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': ""O'Donnell"", 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Steiner', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002560']
2152,33196610,Effect of Emotional Response on the Performance of a Simulated Laparoscopic Task.,"INTRODUCTION


An emotional state impacts task performance and cognition. However, evidence of the effect of an induced emotional state on laparoscopic performance has not yet been documented. We investigated whether surgical residents in whom a positive emotion had been induced would produce a better laparoscopic task performance than residents in whom a negative emotional state had been induced.
METHODS


This controlled laboratory study recruited a total of 53 junior surgical residents who were divided into 3 groups. Each group was required to watch 1 of 3 ten-minute videos designed to evoke a positive, neutral, or negative emotion before performing a laparoscopic cholecystectomy on a virtual simulation model. Task performances, as evaluated by a global assessment form and psychomotor metrics that included task time, errors, and path lengths, were compared between the 3 groups.
RESULTS


Video watching induced different emotions, as measured by a Visual Analog Scale on feelings. The task time was significantly shorter in the positive (13.7 ± 2.5 minutes) than in the neutrally (17.7 ± 3.9 minutes) and the negatively (18.5 ± 3.8 minutes) induced-emotion groups (P < 0.001).Participants in the positive emotion group completed a laparoscopic cholecystectomy with a significantly lower error rate (2 vs. 4 vs. 7, P = 0.036) and shorter right-handed path length (1089.6 ± 250.6 cm vs. 1287.2 ± 355.5 cm vs. 1410.3 ± 304.1 cm, P = 0.010) than the participants in the neutral and negative emotion groups.
CONCLUSIONS


A positive emotion can enhance a simulated laparoscopic task performance as assessed by task time and path length. The results indicate that we might improve surgical task performance by adjusting the surgeon's emotional state. We plan a future study that will continue to investigate whether positive emotions can facilitate skill learning.",2020,"The task time was significantly shorter in the positive (13.7 ± 2.5 minutes) than in the neutrally (17.7 ± 3.9 minutes) and the negatively (18.5 ± 3.8 minutes) induced-emotion groups (P < 0.001).Participants in the positive emotion group completed a laparoscopic cholecystectomy with a significantly lower error rate (2 vs. 4 vs. 7, P = 0.036) and shorter right-handed path length (1089.6 ± 250.6 cm vs. 1287.2 ± 355.5 cm vs. 1410.3 ± 304.1 cm, P = 0.010) than the participants in the neutral and negative emotion groups.
","['surgical residents in whom a positive emotion had been induced would produce a better laparoscopic task performance than residents in whom a negative emotional state had been induced', '53 junior surgical residents who were divided into 3 groups']","['laparoscopic cholecystectomy', 'minute videos designed to evoke a positive, neutral, or negative emotion before performing a laparoscopic cholecystectomy', 'Emotional Response']","['task time', 'shorter right-handed path length', 'Visual Analog Scale on feelings', 'error rate', 'global assessment form and psychomotor metrics that included task time, errors, and path lengths', 'surgical task performance', 'task time and path length']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",53.0,0.0536146,"The task time was significantly shorter in the positive (13.7 ± 2.5 minutes) than in the neutrally (17.7 ± 3.9 minutes) and the negatively (18.5 ± 3.8 minutes) induced-emotion groups (P < 0.001).Participants in the positive emotion group completed a laparoscopic cholecystectomy with a significantly lower error rate (2 vs. 4 vs. 7, P = 0.036) and shorter right-handed path length (1089.6 ± 250.6 cm vs. 1287.2 ± 355.5 cm vs. 1410.3 ± 304.1 cm, P = 0.010) than the participants in the neutral and negative emotion groups.
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""From the Department of General Surgery (J.Y., X.C., H.Y.), Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China; Department of Surgery, (B.Z.), University of Alberta, Edmonton, Alberta, Canada; Department of Hepatobiliary, Pancreatic and Minimally Invasive Surgery (Z.W., X.Y.), Zhejiang Provincial People's Hospital; and Department of Science and Education (Y.C.), Zhejiang Hospital, Hangzhou, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Xiujun', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Zhifei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000514']
2153,33196629,Pharmacologic Modulation of Brain Metabolism by Valproic Acid can Induce a Neuroprotective Environment.,"OBJECTIVE


Traumatic brain injury (TBI) is a leading cause of trauma-related morbidity and mortality. Valproic acid (VPA) has been shown to attenuate brain lesion size and swelling within the first few hours following TBI. As injured neurons are sensitive to metabolic changes, we hypothesized that VPA treatment would alter the metabolic profile in the perilesional brain tissues to create a neuroprotective environment.
METHODS


We subjected swine to combined TBI (12-mm cortical impact) and hemorrhagic shock (40% blood volume loss, and 2-hours of hypotension) and randomized them to two groups (n=5/group): (i) normal saline (NS; 3×hemorrhage volume); (ii) NS + VPA (NS; 3×hemorrhage volume, VPA; 150mg/kg). After six hours, brains were harvested and 100mg of the perilesional tissue was used for metabolite extraction. Samples were analyzed using Reversed-Phase Liquid Chromatography-Mass Spectrometry (RPLC-MS) in positive and negative ion modes and data analyzed using Metaboanalyst software.
RESULTS


In untargeted RPLC-MS analysis, we detected 3750 and 1955 metabolites in positive and negative ion modes, respectively. There were no significantly different metabolites in positive ion mode; however, 167 metabolite features were significantly different (p-values < 0.05) in the negative ion mode, which included VPA derivates. Pathway analysis showed that several pathways were affected in the treatment group, including the biosynthesis of unsaturated fatty acids (p = 0.001). Targeted amino acid analysis on Glycolysis/TCA cycle revealed that VPA treatment significantly decreased the levels of the excitotoxic amino acid serine (p=0.001).
CONCLUSION


VPA can be detected in perilesional tissues in its metabolized form. It also induces metabolic changes in the brains within the first few hours following TBI to create a neuroprotective environment.
LEVEL OF EVIDENCE


not applicable (pre-clinical study).",2020,"Pathway analysis showed that several pathways were affected in the treatment group, including the biosynthesis of unsaturated fatty acids (p = 0.001).",[],"['Valproic acid (VPA', 'normal saline (NS; 3×hemorrhage volume); (ii) NS + VPA', 'VPA']","['levels of the excitotoxic amino acid serine', 'biosynthesis of unsaturated fatty acids', 'metabolic changes']",[],"[{'cui': 'C0042291', 'cui_str': 'valproic acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0984155,"Pathway analysis showed that several pathways were affected in the treatment group, including the biosynthesis of unsaturated fatty acids (p = 0.001).","[{'ForeName': 'Umar F', 'Initials': 'UF', 'LastName': 'Bhatti', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Karnovsky', 'Affiliation': 'Department of Computational Medicine and Bioinformatics, University of Michigan Health System, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Isabel S', 'Initials': 'IS', 'LastName': 'Dennahy', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Kachman', 'Affiliation': 'Michigan Regional Comprehensive Metabolomics Resource Core, University of Michigan Health System, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Vahagn C', 'Initials': 'VC', 'LastName': 'Nikolian', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ben E', 'Initials': 'BE', 'LastName': 'Biesterveld', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Baoling', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000003026']
2154,33196634,A Mobile App for Diabetes Management: Impact on Self-Efficacy Among Patients with Type 2 Diabetes at a Community Hospital.,"BACKGROUND Patients with type 2 diabetes upload and review blood glucose data between clinic visits. Many mobile phone applications (apps) that receive data from a ""connected"" glucometer and that support pattern management are available and have the capacity to make data upload and review less burdensome. The objective of this study was to assess whether the diabetic management app could improve glycemic control and diabetes self-efficacy in a Chinese community hospital by a randomized controlled trial. MATERIAL AND METHODS One-hundred twenty patients with type 2 diabetes registered at the Community Health Service Center of Zhangjiawo Town, Xiqing District, Tianjin City, China were recruited and volunteered to participate in the project. They were randomly divided into the mobile app intervention group (n=60) and the control group (n=60) for a 6-month observation. The control group was given conventional diabetic treatment and the app group was given the mobile app and conventional care. Self-efficacy was measured by the Diabetes Self-Efficacy Scale questionnaire. The differences between the 2 groups in hemoglobin A1c (HbA1c) and diabetes self-efficacy were evaluated at the third and sixth months. RESULTS At the sixth month, patients in the app group showed better HbA1c control (6.71±1.06 vs. 7.22±1.02, P<0.05) and improved self-efficacy score (119.20±9.88 vs. 102.09±10.67, P<0.05). CONCLUSIONS The mobile app helped patients with type 2 diabetes in a community hospital improve therapeutic outcome and self-management behavior. It also provided experiences for prevention and management of other chronic diseases in community hospitals.",2020,"At the sixth month, patients in the app group showed better HbA1c control (6.71±1.06 vs. 7.22±1.02, P<0.05) and improved self-efficacy score (119.20±9.88 vs. 102.09±10.67, P<0.05).","['Patients with Type 2 Diabetes at a Community Hospital', 'One-hundred twenty patients with type 2 diabetes registered at the Community Health Service Center of Zhangjiawo Town, Xiqing District, Tianjin City, China were recruited and volunteered to participate in the project', 'Chinese community hospital', 'Patients with type 2 diabetes upload and review blood glucose data between clinic visits']",['conventional diabetic treatment and the app group was given the mobile app and conventional care'],"['Self-Efficacy', 'glycemic control and diabetes self-efficacy', 'Self-efficacy', 'better HbA1c control', 'self-efficacy score', 'hemoglobin A1c (HbA1c) and diabetes self-efficacy', 'Diabetes Self-Efficacy Scale questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009472', 'cui_str': 'Community health services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",120.0,0.0353108,"At the sixth month, patients in the app group showed better HbA1c control (6.71±1.06 vs. 7.22±1.02, P<0.05) and improved self-efficacy score (119.20±9.88 vs. 102.09±10.67, P<0.05).","[{'ForeName': 'Yangkui', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hisen-I Memorial Hospital and Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China (mainland).'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, Tianjin 1st Central Hospital, Tianjin, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.926719']
2155,31816038,Combination of empagliflozin and linagliptin improves blood pressure and vascular function in type 2 diabetes.,"AIMS


Preserved vascular function represents a key prognostic factor in type 2 diabetes mellitus (T2DM), but data on vascular parameters in this patient cohort are scarce. Patients with T2DM often need more than one drug to achieve optimal glucose control. The aim of this study was to analyse the efficacy of two combination therapies on vascular function in subjects with T2DM.
METHODS AND RESULTS


This prospective, randomized study included 97 subjects with T2DM. Subjects were randomized to either the combination therapy empagliflozin (E) 10 mg with linagliptin (L) 5 mg once daily or metformin (M) 850 or 1000 mg twice daily with insulin glargine (I) once daily. At baseline and after 12 weeks, subjects had peripheral office and 24-h ambulatory blood pressure (BP) measurement and underwent vascular assessment by pulse wave analysis under office and ambulatory conditions. Office, 24-h ambulatory and central BP as well as pulse pressure (PP) decreased after 12 weeks of treatment with E + L, whereas no change was observed in M + I. There were greater decreases in 24-h ambulatory peripheral systolic (between-group difference: -5.2 ± 1.5 mmHg, P = 0.004), diastolic BP (-1.9 ± 1.0 mmHg, P = 0.036), and PP (-3.3 ± 1.0 mmHg, P = 0.007) in E + L than M + I. Central office systolic BP (-5.56 ± 1.9 mmHg, P = 0.009), forward pressure height of the pulse wave (-2.0 ± 0.9 mmHg, P = 0.028), 24-h ambulatory central systolic (-3.6 ± 1.4 mmHg, P = 0.045), diastolic BP (-1.95 ± 1.1 mmHg, P = 0.041), and 24-h pulse wave velocity (-0.14 ± 0.05m/s, P = 0.043) were reduced to a greater extent with E + L.
CONCLUSION


Beyond the effects on glycaemic control, the combination therapy of E + L significantly improved central BP and vascular function compared with the classic combination of M + I.
CLINICALTRIALS.GOV


NCT02752113.",2020,"Office, 24-h ambulatory and central BP as well as pulse pressure (PP) decreased after 12 weeks of treatment with E + L, whereas no change was observed in M + I.","['subjects with T2DM', '97 subjects with T2DM', 'type 2 diabetes mellitus (T2DM', 'type 2 diabetes', 'Patients with T2DM often need more than one drug to achieve optimal glucose control']","['combination therapy empagliflozin (E) 10\u2009mg with linagliptin (L) 5\u2009mg once daily or metformin (M) 850 or 1000\u2009mg twice daily with insulin glargine', 'empagliflozin and linagliptin']","['24-h ambulatory peripheral systolic', 'Office, 24-h ambulatory and central BP as well as pulse pressure (PP', '24-h pulse wave velocity', 'central BP and vascular function', 'peripheral office and 24-h ambulatory blood pressure (BP) measurement', '24-h ambulatory central systolic', 'vascular function', 'blood pressure and vascular function', 'diastolic BP', 'forward pressure height of the pulse wave']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C3153993', 'cui_str': 'Linagliptin 5 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",97.0,0.0804866,"Office, 24-h ambulatory and central BP as well as pulse pressure (PP) decreased after 12 weeks of treatment with E + L, whereas no change was observed in M + I.","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Bosch', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Kannenkeril', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}, {'ForeName': 'Marina V', 'Initials': 'MV', 'LastName': 'Karg', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Striepe', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Bahnhofstraße 20, 49661 Cloppenburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, 91054 Erlangen-Nuremberg, Germany.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz078']
2156,33201741,"An Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction: The EPIC-HF Trial.","Background:  Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.  Methods:  The Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction (EPIC-HF) trial randomized patients with HFrEF from a diverse health system to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered electronically 1 week prior, 3 days prior and 24 hours prior to a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to ""make one positive change"" in HFrEF prescribing. The primary endpoint was the percent of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days, compared to usual care during the same period.  Results:  EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient-activation tools and 145 were controls. Median age was 65 years, 29% female, 11% black, 7% Hispanic, median ejection fraction 32%. Pre-clinic data revealed significant GDMT opportunities, with no patients on target doses of beta-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days later, 49.0% in the intervention and 29.7% in control experienced an initiation or intensification of their GDMT (p=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths, and no significant differences in hospitalization or emergency department visits at 30 days between groups.  Conclusions:  A patient-activation tool delivered electronically prior to a cardiology clinic visit improved clinician intensification of GDMT.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT03334188.",2020,"There were no deaths, and no significant differences in hospitalization or emergency department visits at 30 days between groups.  ","['patients with heart failure with reduced ejection fraction (HFrEF', 'Median age was 65 years, 29% female, 11% black, 7% Hispanic, median ejection fraction 32', 'enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient-activation tools and 145 were controls', 'Chronic Heart Failure with reduced ejection fraction (EPIC-HF) trial randomized patients with HFrEF from a diverse health system']","['guideline-directed medical therapies (GDMT', 'EPIC-HF']","['percent of patients with GDMT medication initiations and dose intensifications', 'hospitalization or emergency department visits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]",306.0,0.0444059,"There were no deaths, and no significant differences in hospitalization or emergency department visits at 30 days between groups.  ","[{'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Venechuk', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'McIlvennan', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Page Ii', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Prateeti', 'Initials': 'P', 'LastName': 'Khazanie', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver CO.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Harger', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Jocelyn S', 'Initials': 'JS', 'LastName': 'Thompson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Tristan J', 'Initials': 'TJ', 'LastName': 'Dow', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Strader', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'Katy E', 'Initials': 'KE', 'LastName': 'Trinkley', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Magid', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buttrick', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.051863']
2157,33197159,Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation.,"BACKGROUND


Guidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm.
METHODS


We randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.
RESULTS


At 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.
CONCLUSIONS


Among patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.).",2020,"Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.
","['303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo', 'patients with atrial fibrillation', 'patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation']","['Cryoablation or Drug Therapy', 'catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control', 'implantable cardiac monitoring device']","['recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia', 'Symptomatic atrial tachyarrhythmia', 'Serious adverse events', 'rate of atrial fibrillation recurrence', 'freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life', 'recurrence of atrial tachyarrhythmia', 'median percentage of time in atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0010408', 'cui_str': 'Cryosurgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0150496', 'cui_str': 'Cardiac monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",303.0,0.0763599,"Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.
","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Wells', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Vidal', 'Initials': 'V', 'LastName': 'Essebag', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Roux', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Yung', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Skanes', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Yaariv', 'Initials': 'Y', 'LastName': 'Khaykin', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Morillo', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Umjeet', 'Initials': 'U', 'LastName': 'Jolly', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Lockwood', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Amit', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Angaran', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Wardell', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lauck', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': ""From Vancouver General Hospital (J.G.A., M.B.), the University of British Columbia (J.G.A., M.W.D., M.B., S.L.), and the Centre for Cardiovascular Innovation (J.G.A., M.W.D.), Vancouver, Montreal Heart Institute, Université de Montréal (J.G.A., L.M.) and McGill University Health Centre (V.E.), Montreal, the University of Ottawa Heart Institute, Ottawa (G.A.W.), Université Laval, Quebec, QC (J.C.), Université de Sherbrooke, Sherbrooke, QC (J.-F.R.), Rouge Valley Centenary Hospital, Scarborough, ON (D.Y.), Western University, London, ON (A.S.), Southlake Regional Health Centre, University of Toronto, Newmarket, ON (Y.K., A.V.), Libin Cardiovascular Institute, University of Calgary, Calgary, AB (C.M.), St. Mary's General Hospital, Kitchener, ON (U.J.), Royal Jubilee Hospital, Victoria, BC (P.N.), Royal Alexandra Hospital, Edmonton, AB (E.L.), McMaster University, Hamilton, ON (G.A.), St. Michael's Hospital, University of Toronto, Toronto (P.A.), Dalhousie University, Halifax, NS (J.S.), and the University of Saskatchewan, Saskatoon, SK (S.W.) - all in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029980']
2158,33197213,Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial.,"BACKGROUND


Despite the recent worldwide dissemination of laparoscopic liver surgery, no high-level evidence supports the oncologic safety of this approach.
OBJECTIVE


To evaluate long-term oncologic outcomes after laparoscopic versus open liver resection in patients with colorectal metastases.
DESIGN


A single-center, assessor-blinded, randomized controlled trial (OSLO-COMET [Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Trial]). (ClinicalTrials.gov: NCT01516710).
SETTING


Oslo University Hospital, the only provider of liver surgery for the 3 million inhabitants of southeastern Norway.
PARTICIPANTS


Patients with resectable colorectal liver metastases were randomly assigned to have open or laparoscopic liver resection.
INTERVENTION


From February 2012 to January 2016, a total of 280 patients were included in the trial (laparoscopic surgery:  n  = 133; open surgery:  n  = 147).
MEASUREMENTS


The primary outcome was postoperative morbidity within 30 days. Five-year rates of overall and recurrence-free survival were predefined secondary end points.
RESULTS


At a median follow-up of 70 months, rates of 5-year overall survival were 54% in the laparoscopic group and 55% in the open group (between-group difference, 0.5 percentage point [95% CI, -11.3 to 12.3 percentage points]; hazard ratio, 0.93 [CI, 0.67 to 1.30];  P  = 0.67). Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49];  P  = 0.57).
LIMITATION


The trial was not powered to detect differences in secondary end points and was not designed to address a noninferiority hypothesis for survival outcomes.
CONCLUSION


In this randomized trial of laparoscopic and open liver surgery, no difference in survival outcomes was found between the treatment groups. However, differences in 5-year overall survival up to about 10 percentage points in either direction cannot be excluded. This trial should be followed by pragmatic multicenter trials and international registries.
PRIMARY FUNDING SOURCE


The South-Eastern Norway Regional Health Authority.",2020,"Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49];  P  = 0.57).
","['patients with colorectal metastases', 'Colorectal Liver Metastases ', 'Patients with resectable colorectal liver metastases', '280 patients were included in the trial ', 'Oslo University Hospital, the only provider of liver surgery for the 3 million inhabitants of southeastern Norway']","['laparoscopic surgery:  n \xa0= 133; open surgery:  n \xa0= 147', 'laparoscopic liver resection', 'laparoscopic and open liver surgery', 'Laparoscopic Versus Open Resection', 'OSLO-COMET [Oslo Randomized Laparoscopic Versus Open Liver Resection', 'laparoscopic versus open liver resection']","['5-year overall survival', 'Rates of 5-year recurrence-free survival', 'survival outcomes', 'rates of 5-year overall survival', 'postoperative morbidity', 'overall and recurrence-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0193373', 'cui_str': 'Operation on liver'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",280.0,0.503681,"Rates of 5-year recurrence-free survival were 30% in the laparoscopic group and 36% in the open group (between-group difference, 6.0 percentage points [CI, -6.7 to 18.7 percentage points]; hazard ratio, 1.09 [CI, 0.80 to 1.49];  P  = 0.57).
","[{'ForeName': 'Davit L', 'Initials': 'DL', 'LastName': 'Aghayan', 'Affiliation': 'The Intervention Centre at Oslo University Hospital and Institute of Clinical Medicine at University of Oslo, Oslo, Norway, and Yerevan State Medical University after Mkhitar Heratsi, Yerevan, Armenia (D.L.A.).'}, {'ForeName': 'Airazat M', 'Initials': 'AM', 'LastName': 'Kazaryan', 'Affiliation': 'The Intervention Centre at Oslo University Hospital, Oslo, and Østfold Hospital Trust, Grålum, Norway, Yerevan State Medical University after Mkhitar Heratsi, Yerevan, Armenia, and I.M. Sechenov First Moscow State Medical University, Moscow, Russia (A.M.K.).'}, {'ForeName': 'Vegar Johansen', 'Initials': 'VJ', 'LastName': 'Dagenborg', 'Affiliation': 'Institute of Clinical Medicine at University of Oslo and Oslo University Hospital, Oslo, Norway (V.J.D., K.F.).'}, {'ForeName': 'Bård I', 'Initials': 'BI', 'LastName': 'Røsok', 'Affiliation': 'Oslo University Hospital Rikshospitalet, Oslo, Norway (B.I.R.).'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway (M.W.F.).'}, {'ForeName': 'Gudrun Maria Waaler', 'Initials': 'GMW', 'LastName': 'Bjørnelv', 'Affiliation': 'Norwegian University of Science and Technology, Trondheim, Norway (G.M.B.).'}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Kristiansen', 'Affiliation': 'The Intervention Centre at Oslo University Hospital, Oslo, Norway (R.K., Å.A.F.).'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Flatmark', 'Affiliation': 'Institute of Clinical Medicine at University of Oslo and Oslo University Hospital, Oslo, Norway (V.J.D., K.F.).'}, {'ForeName': 'Åsmund Avdem', 'Initials': 'ÅA', 'LastName': 'Fretland', 'Affiliation': 'The Intervention Centre at Oslo University Hospital, Oslo, Norway (R.K., Å.A.F.).'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Edwin', 'Affiliation': 'The Intervention Centre at Oslo University Hospital and Institute of Clinical Medicine at University of Oslo, Oslo, Norway (B.E.).'}]",Annals of internal medicine,['10.7326/M20-4011']
2159,33197226,Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100.,"PURPOSE


The role of maintenance therapy for gastric (GC) or gastroesophageal junction cancer (GEJC) is unclear. We investigated avelumab (anti-programmed death ligand-1 [PD-L1]) maintenance after first-line induction chemotherapy for GC/GEJC.
PATIENTS AND METHODS


JAVELIN Gastric 100 was a global, open-label, phase III trial. Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2-negative, locally advanced or metastatic GC or GEJC. Patients without progressive disease after 12 weeks of first-line chemotherapy with oxaliplatin plus a fluoropyrimidine were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia  v  non-Asia). The primary end point was overall survival (OS) after induction chemotherapy in all randomly assigned patients or the PD-L1-positive randomly assigned population (≥ 1% of tumor cells; 73-10 assay).
RESULTS


A total of 805 patients received induction; 499 were randomly assigned to avelumab (n = 249) or continued chemotherapy (n = 250). Median OS was 10.4 months (95% CI, 9.1 to 12.0 months) versus 10.9 months (95% CI, 9.6 to 12.4 months) and 24-month OS rate was 22.1% versus 15.5% with avelumab versus chemotherapy, respectively (hazard ratio [HR], 0.91; 95% CI, 0.74 to 1.11;  P  = .1779). In the PD-L1-positive population (n = 54), the HR for OS was 1.13 (95% CI, 0.57 to 2.23;  P  = .6352). In an exploratory analysis of the PD-L1-positive population, defined as combined positive score ≥ 1 (22C3 assay; n = 137), median OS was 14.9 months (95% CI, 8.7 to 17.3 months) with avelumab versus 11.6 months (95% CI, 8.4 to 12.6 months) with chemotherapy (unstratified HR, 0.72; 95% CI, 0.49 to 1.05). With avelumab and chemotherapy, treatment-related adverse events (TRAEs) occurred in 149 (61.3%) and 184 (77.3%) patients, including grade ≥ 3 TRAEs in 31 (12.8%) and 78 (32.8%) patients, respectively.
CONCLUSION


JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population.",2020,did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population.,"['patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population', 'Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2-negative, locally advanced or metastatic GC or GEJC', 'JAVELIN Gastric 100 was a global, open-label, phase III trial', 'gastric (GC) or gastroesophageal junction cancer (GEJC', '805 patients received induction; 499', 'Gastric 100', 'Patients With Gastric Cancers', 'Patients without progressive disease after 12 weeks of first-line chemotherapy with']","['First-Line Induction Chemotherapy Versus Continuation of Chemotherapy', 'avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia  v  non-Asia', 'oxaliplatin plus a fluoropyrimidine', 'Avelumab Maintenance', 'continued chemotherapy', 'avelumab', 'induction chemotherapy']","['HR for OS', 'overall survival (OS', 'median OS', 'Median OS', 'adverse events (TRAEs', '24-month OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",805.0,0.13146,did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population.,"[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Internal Medicine, Johannes-Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'Department of Oncology, Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary, Omsk, Russian Federation.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Clinical Trial Unit, Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Alina S', 'Initials': 'AS', 'LastName': 'Muntean', 'Affiliation': 'Department of Research, Oncology Institute Prof Dr Ion Chiricuţă, Cluj Napoca, Romania.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Dipartimento di Oncologia Clinica e Sperimentale, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Nechaeva', 'Affiliation': 'Arkhangelsk Clinical Oncological Dispensary, State Budgetary Healthcare Institution of Arkhangelsk Region, Arkhangelsk, Russian Federation.'}, {'ForeName': 'Arinilda C', 'Initials': 'AC', 'LastName': 'Bragagnoli', 'Affiliation': 'Hospital de Câncer de Barretos-Fundação Pio XII, São Paulo, Brazil.'}, {'ForeName': 'Hasan S', 'Initials': 'HS', 'LastName': 'Coşkun', 'Affiliation': 'Department of Medical Oncology, Akdeniz University Medical Faculty, Antalya, Turkey.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cubillo Gracian', 'Affiliation': 'Hospital Universitario HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': 'Eastern Health, Box Hill Hospital, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Safran', 'Affiliation': 'Rhode Island Hospital, Brown University, Providence, RI.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Vaccaro', 'Affiliation': 'Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'Ronald Reagan University of California Los Angeles Medical Center, Santa Monica, CA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Silver', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA; an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA; an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, MA; an affiliate of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, Georges-Pompidou European Hospital, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France.'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00892']
2160,33197270,Individual responses to topical ibuprofen gel or capsaicin cream for painful knee osteoarthritis: a series of n-of-1 trials.,"OBJECTIVES


To determine individual responses to ibuprofen gel or capsaicin cream for painful, radiographic knee OA using a series of n-of-1 trials.
METHODS


Twenty-two participants were allocated 5% ibuprofen gel (A) and 0.025% capsaicin cream (B) in random sequence (AB or BA). Patients underwent up to 3 treatment cycles, each comprising one treatment for 4 weeks, an individualized washout period (maximum 4 weeks), then the other treatment for 4 weeks. Differential (ibuprofen or capsaicin) response was defined when change-from-baseline pain intensity scores (0-10 NRS) differed by ≥1 between treatments in ≥2 cycles within a participant.
RESULTS


A total of 104 treatment periods were aggregated. Mean pain reduction was 1.2 (95% CI: 0.5, 1.8) on ibuprofen and 1.6 (95% CI: 0.9, 2.4) on capsaicin (P = 0.221). Of 22 participants, 4 (18%) had a greater response to ibuprofen, 9 (41%) to capsaicin, 4 (18%) had similar responses, and 5 (23%) were undetermined.
CONCLUSION


Irrespective of equal efficacy overall, 59% of people displayed a greater response to one treatment over the other. Patients who do not benefit from one type of topical treatment should be offered to try another, which may be more effective. N-of-1 trials are useful to identify individual response to treatment.
CLINICAL TRIAL REGISTRATION


https://clinicaltrials.gov, NCT03146689.",2020,"Mean pain reduction was 1.2 (95% CI: 0.5, 1.8) on ibuprofen and 1.6 (95% CI: 0.9, 2.4) on capsaicin (P = 0.221).","['Twenty-two participants', 'painful knee osteoarthritis', 'painful, radiographic knee OA using a series of n-of-1 trials']","['Differential (ibuprofen or capsaicin', 'ibuprofen gel (A) and 0.025% capsaicin cream (B) in random sequence (AB or BA', 'capsaicin', 'topical ibuprofen gel or capsaicin cream', 'ibuprofen gel or capsaicin cream', 'ibuprofen']","['Mean pain reduction', 'change-from-baseline pain intensity scores']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4517400', 'cui_str': '0.025'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0360483', 'cui_str': 'Ibuprofen-containing product in cutaneous dose form'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.0796506,"Mean pain reduction was 1.2 (95% CI: 0.5, 1.8) on ibuprofen and 1.6 (95% CI: 0.9, 2.4) on capsaicin (P = 0.221).","[{'ForeName': 'Monica S M', 'Initials': 'MSM', 'LastName': 'Persson', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stocks', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Sarmanova', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Fernandes', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Walsh', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Weiya', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pain Centre Versus Arthritis, Academic Rheumatology, University of Nottingham, Nottingham, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa561']
2161,33197271,Similar cardiovascular outcomes in patients with diabetes and established or high risk for coronary vascular disease treated with dulaglutide with and without baseline metformin.,"OBJECTIVE 


Recent European Guidelines for Diabetes, Prediabetes and Cardiovascular Diseases introduced a shift in managing patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease by recommending GLP-1 receptor agonists and SGLT-2 inhibitors as initial glucose-lowering therapy. This is questioned since outcome trials of these drug classes had metformin as background therapy. In this post hoc analysis, the effect of dulaglutide on CV events was investigated according to the baseline metformin therapy by means of a subgroup analysis of the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.
RESEARCH DESIGN AND METHODS 


Patients in REWIND (n = 9901; women: 46.3%; mean age: 66.2 years) had type 2 diabetes and either a previous CV event (31%) or high CV risk (69%). They were randomized (1:1) to sc. dulaglutide (1.5 mg/weekly) or placebo in addition to standard of care. The primary outcome was the first of a composite of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular or unknown causes. Key secondary outcomes included a microvascular composite endpoint, all-cause death, and heart failure. The effect of dulaglutide in patients with and without baseline metformin was evaluated by a Cox regression hazard model with baseline metformin, dulaglutide assignment, and their interaction as independent variables. Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by a Cox regression model with adjustments for factors differing at baseline between people with vs. without metformin, identified using the backward selection.
RESULTS 


Compared to patients with metformin at baseline (n = 8037; 81%), those without metformin (n = 1864; 19%) were older and slightly less obese and had higher proportions of women, prior CV events, heart failure, and renal disease. The primary outcome occurred in 976 (12%) participants with baseline metformin and in 281 (15%) without. There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81-1.05) vs. 0.78 (CI 0.61-0.99); interaction P = 0.18]. Findings for key secondary outcomes were similar in patients with and without baseline metformin.
CONCLUSION 


This analysis suggests that the cardioprotective effect of dulaglutide is unaffected by the baseline use of metformin therapy.",2020,There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81-1.05) vs. 0.78 (CI 0.61-0.99); interaction P = 0.18].,"['patients with diabetes and established or high risk for coronary vascular disease treated with', 'Patients in REWIND (n\u2009=\u20099901; women: 46.3%; mean age: 66.2\u2009years) had type 2 diabetes and either a previous CV event (31%) or high CV risk (69', 'patients with and without baseline', 'patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease']","['placebo', 'dulaglutide with and without baseline metformin', 'dulaglutide', 'metformin']","['microvascular composite endpoint, all-cause death, and heart failure', 'Adjusted hazard ratios (HRs) and 95% confidence intervals (CIs', 'CV events', 'first of a composite of nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular or unknown causes', 'higher proportions of women, prior CV events, heart failure, and renal disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",9901.0,0.202898,There was no significant difference in the effect of dulaglutide on the primary outcome in patients with vs. without metformin at baseline [HR 0.92 (CI 0.81-1.05) vs. 0.78 (CI 0.61-0.99); interaction P = 0.18].,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Ferrannini', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Solnavägen 1, Stockholm SE171 77, Sweden.'}, {'ForeName': 'Hertzel', 'Initials': 'H', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Helen Martina', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'Institute of Genetics and Molecular Medicine, University of Edinburgh, Crewe Road, Edinburgh EH4 2XU, UK.'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Department of Medicine, Institut Universitaire de Cardiologie et Pneumologie, Université Laval, Québec City, QC, Canada.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'ECLA, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Paraguay 160, S2000 Rosario, Santa Fe, Argentina.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, 893 Delaware St, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mellbin', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Solnavägen 1, Stockholm SE171 77, Sweden.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, RR-512, Health Sciences Building, University of Washington, Box 356420, 1959 NE Pacific Street, Seattle, WA 98195-6420, \xa0USA.'}, {'ForeName': 'Matthew Casey', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA.'}, {'ForeName': 'Jonathan Edward', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne VIC 3004, Australia.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia and University Santo Amaro, Av. Dr. Dante Pazzanese, 500 - Vila Mariana, São Paulo - SP, 04012-909, Brazil.'}, {'ForeName': 'Jan Neil', 'Initials': 'JN', 'LastName': 'Basile', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, 171 Ashley Ave, Charleston, SC 29425, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Preventive Medicine Section, 1030 Jefferson Ave, Memphis, TN 38104, USA.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital Motol, V Úvalu 84 150 06 Praha 5, Czechia.'}, {'ForeName': 'Mátyás', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Department of Cardiology, Semmelweis University, Hungarian Institute of Cardiology, Üllői út 26, 1085 Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Department of Internal Medicine, Universidad de La Frontera, Francisco Salazar 1145, Temuco, Araucanía, Chile.'}, {'ForeName': 'Lawrence Alan', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Department of Medicine, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, 38 Shuter St, Toronto, ON M5B 1A6, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander UDES, Calle 70 No 55-210 Bucaramanga, Colombia.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""Division of Clinical Research and Training, St. John's Research Institute, 100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034, India.""}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pīrāgs', 'Affiliation': 'Department of Internal Medicine, Latvijas Universitate, Raiņa bulvāris 19, Centra rajons, Riga LV-1586, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Ulitsa Ostrovityanova, 1, Moscow 117997, Russian Federation.'}, {'ForeName': 'Peter Johann', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Observatory, Cape Town 7925, South Africa.'}, {'ForeName': 'Wayne Huey-Herng', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Department of Medicine, Taichung Veterans General Hospital, Rongguang Road, Puli Township, Nantou County, Taichung 54552, Taiwan.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Solnavägen 1, Stockholm SE171 77, Sweden.'}]",European heart journal,['10.1093/eurheartj/ehaa777']
2162,33197285,Long-term outcomes of pexidartinib in tenosynovial giant cell tumors.,"BACKGROUND


The objective of this study was to report on the long-term effects of pexidartinib on tenosynovial giant cell tumor (TGCT).
METHODS


This was a pooled analysis encompassing 3 pexidartinib-treated TGCT cohorts: 1) a phase 1 extension study (NCT01004861; 1000 mg/d; n = 39), 2) ENLIVEN patients randomized to pexidartinib (1000 mg/d for 2 weeks and then 800 mg/d; n = 61), and 3) ENLIVEN crossover patients (NCT02371369; 800 mg/d; n = 30). Eligible patients were 18 years old or older and had a histologically confirmed TGCT that was unresectable and symptomatic. Efficacy endpoints included the best overall response (complete or partial response) and the duration of response (DOR) by the Response Evaluation Criteria in Solid Tumors (RECIST) and the tumor volume score (TVS). The safety assessment included the frequency of treatment-emergent adverse events (TEAEs) and hepatic laboratory abnormalities (aminotransferase elevations and mixed/cholestatic hepatotoxicity). The data cutoff was May 31, 2019.
RESULTS


One hundred thirty patients with TGCT received pexidartinib (median treatment duration, 19 months; range, 1 to 76+ months); 54 (42%) remained on treatment at the end of the analysis (26 months after initial data cut of March 2017). The RECIST overall response rate (ORR) was 60%; the TVS ORR was 65%. The median times to response were 3.4 (RECIST) and 2.8 months (TVS), with 48 of the responding patients (62%) achieving a RECIST partial response by 6 months and with 72 (92%) doing so by 18 months. The median DOR was reached for TVS (46.8 months). Reported TEAEs were mostly low-grade, with hair color changes being most frequent (75%). Most liver abnormalities (92%) were aminotransferase elevations; 4 patients (3%) experienced mixed/cholestatic hepatotoxicity (all within the first 2 months of treatment), which was reversible in all cases (recovery spanned 1-7 months).
CONCLUSIONS


This study demonstrates the prolonged efficacy and tolerability of long-term pexidartinib treatment for TGCT.",2020,The safety assessment included the frequency of treatment-emergent adverse events (TEAEs) and hepatic laboratory abnormalities (aminotransferase elevations and mixed/cholestatic hepatotoxicity).,"['Eligible patients were 18 years old or older and had a histologically confirmed TGCT that was unresectable and symptomatic', 'tenosynovial giant cell tumors', 'One hundred thirty patients with']",['TGCT'],"['RECIST partial response', 'overall response (complete or partial response) and the duration of response (DOR) by the Response Evaluation Criteria in Solid Tumors (RECIST) and the tumor volume score (TVS', 'frequency of treatment-emergent adverse events (TEAEs) and hepatic laboratory abnormalities (aminotransferase elevations and mixed/cholestatic hepatotoxicity', 'aminotransferase elevations', 'RECIST overall response rate (ORR', 'efficacy and tolerability', 'cholestatic hepatotoxicity', 'Most liver abnormalities', 'median times to response', 'TVS ORR', 'median DOR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1318543', 'cui_str': 'Fibrous histiocytoma of tendon sheath'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1318543', 'cui_str': 'Fibrous histiocytoma of tendon sheath'}]","[{'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}]",130.0,0.079309,The safety assessment included the frequency of treatment-emergent adverse events (TEAEs) and hepatic laboratory abnormalities (aminotransferase elevations and mixed/cholestatic hepatotoxicity).,"[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wagner', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tap', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Palmerini', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Santa Monica, California.'}, {'ForeName': 'Jayesh', 'Initials': 'J', 'LastName': 'Desai', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Healey', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Michiel A J', 'Initials': 'MAJ', 'LastName': 'van de Sande', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Bernthal', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Santa Monica, California.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Staals', 'Affiliation': 'IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Peterfy', 'Affiliation': 'Spire Sciences, Inc, Boca Raton, Florida.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Frezza', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Henry H', 'Initials': 'HH', 'LastName': 'Hsu', 'Affiliation': 'Plexxikon, Berkeley, California.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Dale E', 'Initials': 'DE', 'LastName': 'Shuster', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Stacchiotti', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Cancer,['10.1002/cncr.33312']
2163,33197294,Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals.,"BACKGROUND/OBJECTIVES


Frail participants are often under-represented in randomized trials, raising questions about outcomes of interventions in real-world settings. Frailty is strongly associated with vulnerability to illness and adverse health outcomes. We studied the impact of frailty on recombinant zoster vaccine (RZV) clinical outcomes.
DESIGN/SETTING


Data from two previously conducted phase III randomized trials of RZV were pooled. These two parent trials were conducted concurrently at the same study sites using the same methods.
PARTICIPANTS/INTERVENTION


In the two parent studies, participants aged ≥50 years (ZOE-50 study) and ≥70 years (ZOE-70 study), respectively, were randomized 1:1 to receive two doses of RZV or placebo.
MEASUREMENTS


In the current ZOE-Frailty study (NCT03563183), a frailty index was created using previously validated methods. Clinical outcomes assessed by frailty status included vaccine efficacy, immunogenicity, reactogenicity, and safety.
RESULTS


Of 29,305 participants from the pooled ZOE-50 and ZOE-70 total vaccinated cohort, 92% were included in this study. Mean age was 68.8 years; 58.1% were women; 45.6% were pre-frail and 11.3% frail. The percentage of frail participants increased with age from 5.7% aged 50-59 years to 22.7% aged ≥80 years. RZV vaccine efficacy against herpes zoster was >90% for all frailty subgroups (non-frail: 95.8% (95% confidence interval = 91.6-98.2), pre-frail: 90.4% (84.4-94.4), frail: 90.2% (75.4-97.0)). The RZV group demonstrated robust anti-gE antibody and gE-specific CD42+ responses, with mean concentrations remaining above pre-vaccination levels at least 3 years post-dose two, in all frailty subgroups. In the RZV group, the percentage of participants reporting solicited adverse events tended to decrease with increasing frailty.
CONCLUSION


The relatively nonrestrictive inclusion/exclusion criteria in the parent ZOE studies resulted in a range of participants that included frail and pre-frail older adults. RZV significantly reduced the risk of herpes zoster across all frailty subgroups.",2020,"RZV vaccine efficacy against herpes zoster was >90% for all frailty subgroups (non-frail: 95.8% (95% confidence interval = 91.6-98.2), pre-frail: 90.4% (84.4-94.4), frail: 90.2% (75.4-97.0)).","['frail participants increased with age from 5.7% aged 50-59 years to 22.7% aged ≥80 years', 'participants that included frail and pre-frail older adults', 'Frail participants', '29,305 participants from the pooled ZOE-50 and ZOE-70 total vaccinated cohort', 'participants aged ≥50 years (ZOE-50 study) and ≥70 years (ZOE-70 study', 'Mean age was 68.8 years; 58.1% were women; 45.6% were pre-frail and 11.3% frail', 'Frail Individuals']","['Recombinant Zoster Vaccine', 'RZV or placebo', 'RZV', 'recombinant zoster vaccine (RZV']","['RZV vaccine efficacy against herpes zoster', 'robust anti-gE antibody and gE-specific CD42+ responses', 'vaccine efficacy, immunogenicity, reactogenicity, and safety', 'risk of herpes zoster']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",29305.0,0.363418,"RZV vaccine efficacy against herpes zoster was >90% for all frailty subgroups (non-frail: 95.8% (95% confidence interval = 91.6-98.2), pre-frail: 90.4% (84.4-94.4), frail: 90.2% (75.4-97.0)).","[{'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Joon H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Freelance c/o GSK, Wavre, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dessart', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Riley', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Schmader', 'Affiliation': 'Division of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Cunningham', 'Affiliation': 'The Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, Maryland, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Andrew', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Geriatrics Society,['10.1111/jgs.16917']
2164,33197347,"In older adults with type 1 diabetes, continuous glucose monitoring reduced hypoglycemia over 6 months.","SOURCE CITATION


Pratley RE, Kanapka LG, Rickels MR, et al.  Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial.  JAMA. 2020;323:2397-406. 32543682.",2020,"SOURCE CITATION


Pratley RE, Kanapka LG, Rickels MR, et al.  ",['older adults with type 1 diabetes'],['continuous glucose monitoring'],['hypoglycemia'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.0176603,"SOURCE CITATION


Pratley RE, Kanapka LG, Rickels MR, et al.  ","[{'ForeName': 'Darin E', 'Initials': 'DE', 'LastName': 'Olson', 'Affiliation': 'Emory University School of Medicine and the Atlanta VAHCS, Atlanta, Georgia, USA (D.E.O.).'}]",Annals of internal medicine,['10.7326/ACPJ202011170-054']
2165,33197348,"In chronic plaque psoriasis, roflumilast cream safely increased likelihood of clear or almost clear state at 6 weeks.","SOURCE CITATION


Lebwohl MG, Papp KA, Stein Gold L, et al.  Trial of roflumilast cream for chronic plaque psoriasis.  N Engl J Med. 2020;383:229-39. 32668113.",2020,Trial of roflumilast cream for chronic plaque psoriasis.  ,['chronic plaque psoriasis'],['roflumilast cream'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0965618', 'cui_str': 'Roflumilast'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]",[],,0.0156617,Trial of roflumilast cream for chronic plaque psoriasis.  ,"[{'ForeName': 'Satveer K', 'Initials': 'SK', 'LastName': 'Mahil', 'Affiliation': ""St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, and Kings College London, London, England, UK (S.K.M., C.H.S.).""}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': ""St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, and Kings College London, London, England, UK (S.K.M., C.H.S.).""}]",Annals of internal medicine,['10.7326/ACPJ202011170-055']
2166,33197356,Successful Implicit Vocabulary Intervention for Three Cantonese-Speaking Toddlers: A Replicated Single-Case Design.,"Purpose We report on a replicated single-case design study that measured the feasibility of an expressive vocabulary intervention for three Cantonese-speaking toddlers with small expressive lexicons relative to their age. The aim was to assess the cross-cultural and cross-linguistic feasibility of an intervention method developed for English-speaking children. Method A nonconcurrent multiple-baseline design was used with four baseline data points and 16 intervention sessions per participant. The intervention design incorporated implicit learning principles, high treatment dosage, and control of the phonological neighborhood density of the stimuli. The children (24-39 months) attended 7-9 weeks of twice weekly input-based treatment in which no explicit verbal production was required from the child. Each target word was provided as input a minimum of 64 times in at least two intervention sessions. Treatment feasibility was measured by comparison of how many of the target and control words the child produced across the intervention period, and parent-reported expressive vocabulary checklists were completed for comparison of pre- and postintervention child spoken vocabulary size. An omnibus effect size for the treatment effect of the number of target and control words produced across time was calculated using Kendall's Tau. Results There was a significant treatment effect for target words learned in intervention relative to baselines, and all children produced significantly more target than control words across the intervention period. The effect of phonological neighborhood density on expressive word production could not be evaluated because two of the three children learned all target words. Conclusion The results provide cross-cultural evidence of the feasibility of a model of intervention that incorporated a high-dosage, cross-situational statistical learning paradigm to teach spoken word production to children with small expressive lexicons.",2020,"There was a significant treatment effect for target words learned in intervention relative to baselines, and all children produced significantly more target than control words across the intervention period.","['English-speaking children', 'children with small expressive lexicons', 'three Cantonese-speaking toddlers with small expressive lexicons relative to their age', 'Three Cantonese-Speaking Toddlers']","['phonological neighborhood density', 'Successful Implicit Vocabulary Intervention', 'expressive vocabulary intervention']",[],"[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],3.0,0.0242192,"There was a significant treatment effect for target words learned in intervention relative to baselines, and all children produced significantly more target than control words across the intervention period.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'S-Y Ng', 'Affiliation': 'Human Communication, Development, and Information Sciences, Faculty of Education, University of Hong Kong.'}, {'ForeName': 'Stephanie F', 'Initials': 'SF', 'LastName': 'Stokes', 'Affiliation': 'Human Communication, Development, and Information Sciences, Faculty of Education, University of Hong Kong.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Alt', 'Affiliation': 'University of Arizona, Tucson.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00087']
2167,33197396,"Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.","BACKGROUND


Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation.
METHODS


For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18-75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565.
FINDINGS


Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36-73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6-30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3-67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7-59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed.
INTERPRETATION


Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment.
FUNDING


National Heart, Lung, and Blood Institute.",2020,"Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6-30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3-67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7-59·2; posterior probability of ECMO superiority 0·9861).","['adults aged 18-75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min', 'The mean age was 59 years (range 36-73), and 25 (83%) of 30 patients were men', 'Between Aug 8, 2019, and June 14, 2020', 'patients with OHCA and refractory ventricular fibrillation', 'patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST', 'patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment']","['ECMO-facilitated resuscitation or standard ACLS treatment', 'extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment', 'standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation']","['safety, survival, and functional assessment at hospital discharge', 'Cumulative 6-month survival', 'survival to hospital discharge', 'Survival to hospital discharge', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0887907', 'cui_str': 'Advanced cardiac life support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0887907', 'cui_str': 'Advanced cardiac life support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.129138,"Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6-30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3-67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7-59·2; posterior probability of ECMO superiority 0·9861).","[{'ForeName': 'Demetris', 'Initials': 'D', 'LastName': 'Yannopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA. Electronic address: yanno001@umn.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bartos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raveendran', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Walser', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Connett', 'Affiliation': 'Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': 'Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Collins', 'Affiliation': 'Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Kalra', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Kosmopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA; Division of Cardiology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'John', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shaffer', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Frascone', 'Affiliation': 'St Paul Fire and Emergency Medical Services, St Paul, MN, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wesley', 'Affiliation': 'M Health Fairview Emergency Medical Services, Minneapolis, MN, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Conterato', 'Affiliation': 'North Memorial Emergency Medical Services, Robbinsdale, MN, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Biros', 'Affiliation': 'Department of Emergency Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Tolar', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32338-2']
2168,33202719,Influence of Probiotics on the Salivary Microflora Oral Streptococci and Their Integration into Oral Biofilm.,"Probiotics' ability to integrate into dental biofilms is not yet clarified. The aim of this trial was to detect probiotic bacteria from probiotic products in dental biofilm and saliva during and after intake. In this parallel, randomized clinical trial, 39 subjects wore customized appliances to build up intra-oral biofilms (72-h periods). The trial was divided into screening (S) to determine baseline biofilm flora, intervention (I), and wash out (WO). During I (28 days), subjects consumed a product containing (a)  Enterococcus faecalis  (b)  Lactobacillus casei , or (c)  Lactobacillus rhamnosus  GG. Probiotic bacteria and Streptococci spp. were detected in the biofilms and saliva of the 35 subjects that were included in the analysis. During I and WO, the ratio of probiotics in the biofilm was very low compared to total bacterial load, while saliva had slightly but not significantly higher values. No significant changes of probiotic bacteria ( p  > 0.05) were found at any visit during I or WO. The proportion of streptococci was significantly reduced ( p  < 0.05) during I and even lower in WO, compared to S. Probiotic bacteria could neither integrate nor persist in dental biofilm and saliva but did influence the growth of streptococci in biofilm and saliva.",2020,"The proportion of streptococci was significantly reduced ( p  < 0.05) during I and even lower in WO, compared to S. Probiotic bacteria could neither integrate nor persist in dental biofilm and saliva but did influence the growth of streptococci in biofilm and saliva.","['39 subjects wore customized appliances to build up intra-oral biofilms (72-h periods', '35 subjects that were included in the analysis']","['subjects consumed a product containing (a)  Enterococcus faecalis  (b)  Lactobacillus casei , or (c)  Lactobacillus rhamnosus  GG']","['probiotic bacteria', 'proportion of streptococci']","[{'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",39.0,0.0542296,"The proportion of streptococci was significantly reduced ( p  < 0.05) during I and even lower in WO, compared to S. Probiotic bacteria could neither integrate nor persist in dental biofilm and saliva but did influence the growth of streptococci in biofilm and saliva.","[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Arweiler', 'Affiliation': 'Department of Periodontology and Peri-Implant Diseases, Philipps-University, 35039 Marburg, Germany.'}, {'ForeName': 'Thorsten M', 'Initials': 'TM', 'LastName': 'Auschill', 'Affiliation': 'Department of Periodontology and Peri-Implant Diseases, Philipps-University, 35039 Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heumann', 'Affiliation': 'Department of Statistics, Ludwig-Maximilians University, 80539 Munich, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry & Periodontology, Center for Dental Medicine, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry & Periodontology, Center for Dental Medicine, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9110803']
2169,33202825,Efficacy and Toxicity of Different Chemotherapy Protocols for Concurrent Chemoradiation in Non-Small Cell Lung Cancer-A Secondary Analysis of the PET Plan Trial.,"(1) Background: The optimal chemotherapy (CHT) regimen for concurrent chemoradiation (cCRT) is not well defined. In this secondary analysis of the international randomized PET-Plan trial, we evaluate the efficacy of different CHT. (2) Methods: Patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume definition and received isotoxically dose-escalated cCRT using cisplatin 80 mg/m 2  (day 1, 22) and vinorelbin 15 mg/m 2  (day 1, 8, 22, 29) (P1) or cisplatin 20 mg/m 2  (day 1-5, 29-33) and vinorelbin 12.5 mg/m 2  (day 1, 8, 15, 29, 36, 43) (P2) or carboplatin AUC1 (day 1-5, 29-33) and vinorelbin 12.5 mg/m 2  (day 1, 8, 15, 29, 36, 43) (P3) or other CHT at the treating physician's discretion. (3) Results: Between 05/2009 and 11/2016, 205 patients were randomized and 172 included in the per-protocol analysis. Patients treated in P1 or P2 had a better overall survival (OS) compared to P3 ( p  = 0.015,  p  = 0.01, respectively). Patients treated with carboplatin had a worse OS compared to cisplatin (HR 1.78,  p  = 0.03), but the difference did not remain significant after adjusting for age, ECOG, cardiac function creatinine and completeness of CHT. (4) Conclusions: Carboplatin doublets show no significant difference compared to cisplatin, after adjusting for possibly relevant factors, probably due to existing selection bias.",2020,"Patients treated with carboplatin had a worse OS compared to cisplatin (HR 1.78,  p  = 0.03), but the difference did not remain significant after adjusting for age, ECOG, cardiac function creatinine and completeness of CHT.","['205 patients were randomized and 172 included in the per-protocol analysis', 'Patients with inoperable NSCLC']","['cisplatin', 'vinorelbin', 'carboplatin', 'cCRT using cisplatin', 'carboplatin AUC1', 'chemotherapy (CHT) regimen for concurrent chemoradiation (cCRT']","['overall survival (OS', 'ECOG, cardiac function creatinine and completeness of CHT', 'Efficacy and Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",205.0,0.219451,"Patients treated with carboplatin had a worse OS compared to cisplatin (HR 1.78,  p  = 0.03), but the difference did not remain significant after adjusting for age, ECOG, cardiac function creatinine and completeness of CHT.","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkika', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lenz', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schimek-Jasch', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Cornelius F', 'Initials': 'CF', 'LastName': 'Waller', 'Affiliation': 'Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kremp', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaefer-Schuler', 'Affiliation': 'Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mix', 'Affiliation': 'Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Küsters', 'Affiliation': 'Department of Radiation Oncology, Kliniken Maria Hilf, 41063 Mönchengladbach, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tosch', 'Affiliation': 'Department of Nuclear Medicine, Helios University Hospital Wuppertal, 42283 Wuppertal, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hehr', 'Affiliation': 'Department of Radiation Oncology, Marienhospital, 70199 Stuttgart, Germany.'}, {'ForeName': 'Susanne Martina', 'Initials': 'SM', 'LastName': 'Eschmann', 'Affiliation': 'Department of Nuclear Medicine, Marienhospital, 70199 Stuttgart, Germany.'}, {'ForeName': 'Yves-Pierre', 'Initials': 'YP', 'LastName': 'Bultel', 'Affiliation': 'Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, 54290 Trier, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hass', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, 39120 Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Alexander Henry', 'Initials': 'AH', 'LastName': 'Thieme', 'Affiliation': 'Department of Radiation Oncology, Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stockinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dieckmann', 'Affiliation': 'Department of Radiotherapy, Vienna General Hospital, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Miederer', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Holl', 'Affiliation': 'Department of Nuclear Medicine, Kliniken Schwerin, 19055 Schwerin, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Rischke', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Adebahr', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Hospital of Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Binder', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}]",Cancers,['10.3390/cancers12113359']
2170,33202849,Boosting Psychological Well-Being through a Social Mindfulness-Based Intervention in the General Population.,"The benefits of mindfulness meditation among clinical and non-clinical populations have been largely reported in literature. Existing mindfulness-based programs are particularly useful in targeting specific populations while researchers have pointed out the possibility of developing programs adapted to the audience and the context. In this two-groups pre-post experimental design we developed a mindfulness-based social intervention program to target individuals from the general population. Here we present a two-groups pre-post experimental design to investigate its effectiveness on participants' psychological functioning assessed by eight self-reported questionnaires (CORE-OM, FFMQ, SWLS, PANAS, PSS, SCS, WEMWBS, SHS) which encompass different domains of well-being, mindfulness and emotional functioning. Participants, recruited on voluntary basis, were randomly allocated to treated or passive control groups and were aware of group allocation. The intervention comprises a 12-week meditation training in a big group that represents the social aspect of meditation. Data were analysed via a linear mixed effect model and intention to treat. Statistically significant results were obtained for global score of CORE-OM (β = -0.20 [-0.30; -0.10],  p  = 0.0002), FFMQ (β = 0.20 [0.12; -0.28],  p  < 0.0001), SWLS (β = 1.43 [0.42; 2.45],  p  = 0.006), positive PANAS (β = 1.99 [0.95; 3.04],  p  = 0.0002), negative PANAS (β = -1.67 [-2.92; -0.43],  p  = 0.009), PSS (β = -2.98 [-4.25; -1.71],  p  < 0.0001), WEMWBS (β = 4.38 [2.93; 5.83],  p  < 0.0001) and SHS (β = 1.43 [0.42; 2.45],  p  = 0.006). Our intervention is causally associated with an improvement of the psychological functioning and hence can be considered as a preventive measure that may potentially reduce the risk of developing psychological problems and improve the subject's general well-being. Given the voluntary recruitment, our inference only applies to those individuals who have decided to experience meditation as a way to well-being and not to a random person from the general population.",2020,"Statistically significant results were obtained for global score of CORE-OM (β = -0.20 [-0.30; -0.10],  p  = 0.0002), FFMQ (β = 0.20 [0.12; -0.28],  p  < 0.0001), SWLS (β = 1.43 [0.42; 2.45],  ","['Participants, recruited on voluntary basis']","['mindfulness-based social intervention program', 'mindfulness meditation', 'meditation training']","['global score of CORE-OM', 'FFMQ', ""participants' psychological functioning assessed by eight self-reported questionnaires (CORE-OM, FFMQ, SWLS, PANAS, PSS, SCS, WEMWBS, SHS""]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0796135', 'cui_str': 'Renpenning syndrome'}]",,0.0334232,"Statistically significant results were obtained for global score of CORE-OM (β = -0.20 [-0.30; -0.10],  p  = 0.0002), FFMQ (β = 0.20 [0.12; -0.28],  p  < 0.0001), SWLS (β = 1.43 [0.42; 2.45],  ","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bubbico', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Salvato', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Berzuini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Bruno', 'Affiliation': 'Istituto di Psicosintesi, 20124 Milano, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Bottini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17228404']
2171,33202893,Modification of Pronated Foot Posture after a Program of Therapeutic Exercises.,"Working on the intrinsic musculature of the foot has been shown to be effective in controlling pronation. However, the potential coadjuvant effect that involving other muscle groups might have on foot posture remains unknown. The aim was, therefore, to assess whether a 9-week intrinsic and extrinsic foot and core muscle strength program influenced foot posture in pronated subjects. The participants were 36 healthy adults with pronated feet that were randomly assigned to two groups. The experimental group ( n  = 18) performed a strengthening exercise protocol for 9 weeks (two sessions of 40 min per week), while the control group ( n  = 18) did not do these exercises. After 9 weeks, the foot posture index (FPI) scores of the two groups were analyzed to detect possible changes. The FPI at the baseline was 8.0 ± 1.5. After the 9 weeks, the experimental group showed significantly reduced FPI from 8.1 ± 1.7 to 6.4 ± 2.1 ( p  = 0.001), while the control group had the same score as pre-intervention (FPI 8 ± 1.2,  p  = 1.0). The FPI scores showed no significant differences by sex. Strengthening of the intrinsic and extrinsic foot and core muscles contributed to improving foot posture in adults, reducing their FPI by 1.66 points.",2020,"Strengthening of the intrinsic and extrinsic foot and core muscles contributed to improving foot posture in adults, reducing their FPI by 1.66 points.","['pronated subjects', '36 healthy adults with pronated feet']","['strengthening exercise protocol', '9-week intrinsic and extrinsic foot and core muscle strength program']","['foot posture index (FPI) scores', 'FPI scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",36.0,0.0179313,"Strengthening of the intrinsic and extrinsic foot and core muscles contributed to improving foot posture in adults, reducing their FPI by 1.66 points.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Valle-Estévez', 'Affiliation': 'Podiatric Clinic Las Lomas, Avda Salinera 6L-6K, 19005 Guadalajara, Spain.'}, {'ForeName': 'Peñas Albas', 'Initials': 'PA', 'LastName': 'Fraile-García', 'Affiliation': 'Physiotherapy Clinic PAFG, Tenerías 4, 10610 Cabezuela del Valle, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Martínez-Nova', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Gómez-Martín', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Escamilla-Martínez', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228406']
2172,33197570,Effect of Mind Sound Resonance Technique (MSRT - a Yoga-Based Relaxation Technique) on Psychological Variables and Cognition in School Children: A Randomized Controlled Trial.,"OBJECTIVE


School children undergo stress, which could impact their psychological functions and cognitive abilities. Yoga practices have been found useful in enhancing psychological functions and performance. The current study was planned to evaluate a yoga-based relaxation technique's efficacy as an extracurricular activity on psychological state and cognitive function.
DESIGN AND SETTING


This study was a parallel-group randomized controlled trial conducted at a government school in south India.
PARTICIPANTS


Sixty students with age ranging between 14-16 years (mean age ± SD; 15.3 ± 0.71 years) satisfying the inclusion and exclusion criteria were randomized to experimental and control groups with an allocation ratio of 1:1.
INTERVENTION


Experimental group received Mind Sound Resonance Technique (MSRT), whereas the control group performed supine rest (SR) for two-weeks.
OUTCOME MEASURES


Participants were assessed with State trait anxiety inventory - short form, Mind Wandering Questionnaire, State Mindfulness Attention Awareness Scale, and Trail making task at baseline and post-intervention.
RESULTS


Experimental group showed a reduction in state anxiety and mind wandering with improvement in state mindfulness and performance in the Trail-making task compared to the control group.
CONCLUSION


Results of the current trial indicate the beneficial role of MSRT in enhancing psychological and cognitive functions in children. Further, large-scale trials are warranted to ascertain the usefulness of the technique.",2020,"RESULTS


Experimental group showed a reduction in state anxiety and mind wandering with improvement in state mindfulness and performance in the Trail-making task compared to the control group.
","['School children undergo stress', 'government school in south India', 'School Children', 'children', 'Sixty students with age ranging between 14-16 years (mean age\u2009±\u2009SD; 15.3\u2009±\u20090.71 years) satisfying the inclusion and exclusion criteria']","['MSRT', 'Experimental group received Mind Sound Resonance Technique (MSRT', 'control group performed supine rest (SR', 'Mind Sound Resonance Technique (MSRT - a Yoga-Based Relaxation Technique']","['state anxiety', 'state mindfulness and performance', 'Psychological Variables and Cognition', 'State trait anxiety inventory - short form, Mind Wandering Questionnaire, State Mindfulness Attention Awareness Scale, and Trail making task']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}]",60.0,0.037303,"RESULTS


Experimental group showed a reduction in state anxiety and mind wandering with improvement in state mindfulness and performance in the Trail-making task compared to the control group.
","[{'ForeName': 'U S', 'Initials': 'US', 'LastName': 'Anusuya', 'Affiliation': 'Annai College of Naturopathy and Yoga Sciences, Anaikudi Road, Kovilachery, Kumbakonam, Tamil Nadu, India.'}, {'ForeName': 'Sriloy', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Center for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Apar Avinash', 'Initials': 'AA', 'LastName': 'Saoji', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India. Electronic address: aparsaoji@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102606']
2173,33197609,Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework.,"BACKGROUND


Behavioral lifestyle intervention (BLI) is recommended as a first-line treatment for obesity. While BLI has been adapted for online delivery to improve potential for dissemination while reducing costs and barriers to access, weight losses are typically inferior to gold standard treatment delivered in-person. It is therefore important to refine and optimize online BLI in order to improve the proportion of individuals who achieve a minimum clinically significant weight loss and mean weight loss.
STUDY DESIGN


Five experimental intervention components will be tested as adjuncts to an established 12-month online BLI: virtual reality for BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition. Following the Multiphase Optimization Strategy (MOST) framework, the components will first be refined and finalized during Preparation Phase pilot testing and then evaluated in a factorial experiment with 384 adults with overweight or obesity. A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components. Mediation analysis will be conducted to test hypothesized mechanisms of action and a moderator analysis will be conducted to understand for whom and under what circumstances the interventions are effective.
CONCLUSION


This study will provide important information about intervention strategies that are useful for improving outcomes of online BLI. The finalized treatment package will be suitable for testing in a future randomized trial in the MOST Evaluation Phase.",2020,A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components.,['384 adults with overweight or obesity'],"['BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition', 'behavioral obesity treatment delivered online', 'Behavioral lifestyle intervention (BLI']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]",[],384.0,0.0288169,A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components.,"[{'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA. Electronic address: john_g_thomas@brown.edu.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Hekler', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego (UCSD), Center for Wireless and Population Health Systems, Qualcomm Institute at UCSD, 9500 Gilman Ave., San Diego, CA 92093, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Hallie M', 'Initials': 'HM', 'LastName': 'Espel-Huynh', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 S Main St., Providence, RI 02903, USA.'}, {'ForeName': 'E Whitney', 'Initials': 'EW', 'LastName': 'Evans', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Computer Science, Brown University, 115 Waterman St., Providence, RI 02906, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106217']
2174,33197610,Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings.,"The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.",2020,"Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.",[],['MBRP-SA'],['risk of morbidity and mortality'],[],[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21.0,0.019142,"Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Hemenway', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'University of New Mexico, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Unrod', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'University of Utah, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA. Electronic address: christine.vinci@moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106218']
2175,33197648,Effect of individualized coaching at home on walking capacity in subacute stroke patients: a randomized controlled trial (Ticaa'dom).,"BACKGROUND


The gains in walking capacity achieved during rehabilitation often plateau, or are lost, when the patient returns home. Moreover, maintaining or increasing the patient's daily physical activity level after a stroke remains challenging. We aimed to evaluate the effectiveness of a six-month individualized coaching program at home on walking capacity, as evaluated by the six-minute walk test in subacute stroke patients.
METHODS


Stroke patients in the physical medicine and rehabilitation service participated in a monocentric observer blinded randomized controlled trial with two groups, intervention versus usual care control. The inclusion criteria were: age ≥18 years, first ischemic or hemorrhagic stroke, and stroke within <6 months. Participants were randomly assigned (blocks of variable size) to an intervention group(EG) receiving individualized coaching on physical activity, or to a control group(CG) receiving standard care. The six-month program was composed of monitored physical activity, home visits and a weekly phone call. Participants were evaluated after hospital discharge(T0), at the end of the six-month program(T1) and six months later(follow-up; T2). The primary outcome was the walking distance performance, as evaluated with the six-minute walk test at T1.
RESULTS


Eighty-three participants (age: 61y [IQR=22]; time post-stroke: 2.4 month [IQR=1.7]; Barthel index: 100[IQR=5]) were included in the study: (EG, n=41; CG, n=42). The difference between the two groups was not significant at T1(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; p=0.168) and at T2(425m [IQR=121] for the EG vs. 382m [IQR=219] for the CG; p=0.208).
CONCLUSION


Our study shows no difference in the six-minute walk test between the two groups of subacute stroke patients after 6 months of the individualized coaching program, combining home visits, feedback on daily performance and weekly telephone calls. http://ClinicalTrials.gov (NCT01822938) Source funding: Limousin Regional Council.",2020,The difference between the two groups was not significant at T1(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; p=0.168) and at T2(425m,"['subacute stroke patients', 'Stroke patients in the physical medicine and rehabilitation service participated', 'The inclusion criteria were: age ≥18 years, first ischemic or hemorrhagic stroke, and stroke within <6 months', 'Eighty-three participants (age: 61y [IQR=22]; time post-stroke: 2.4 month [IQR=1.7]; Barthel index: 100[IQR=5]) were included in the study: (EG, n=41; CG, n=42']","['individualized coaching', 'individualized coaching on physical activity, or to a control group(CG) receiving standard care', 'intervention versus usual care control', 'six-month individualized coaching program']","['walking capacity', ""patient's daily physical activity level"", 'walking distance performance, as evaluated with the six-minute walk test at T1']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4302556', 'cui_str': 'Physical medicine and rehabilitation service'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",,0.0863257,The difference between the two groups was not significant at T1(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; p=0.168) and at T2(425m,"[{'ForeName': 'Mandigout', 'Initials': 'M', 'LastName': 'Stéphane', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France. Electronic address: stephane.mandigout@unilim.fr.'}, {'ForeName': 'Chaparro', 'Initials': 'C', 'LastName': 'David', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France.'}, {'ForeName': 'Borel', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kamoun', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France.'}, {'ForeName': 'Salle', 'Initials': 'S', 'LastName': 'Jean-Yves', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France; Department of Medicine and physical rehabilitation service, Limoges University Hospital, F- 87000 Limoges, France.'}, {'ForeName': 'Compagnat', 'Initials': 'C', 'LastName': 'Maxence', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France; Department of Medicine and physical rehabilitation service, Limoges University Hospital, F- 87000 Limoges, France.'}, {'ForeName': 'Daviet', 'Initials': 'D', 'LastName': 'Jean-Christophe', 'Affiliation': 'Limoges University, HAVAE laboratory, EA 6310, 123, avenue Albert Thomas, 87060 Limoges, France; Department of Medicine and physical rehabilitation service, Limoges University Hospital, F- 87000 Limoges, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.11.001']
2176,33197654,No effect of anodal tDCS on motor cortical excitability and no evidence for responders in a large double-blind placebo-controlled trial.,"BACKGROUND


Transcranial direct current stimulation (tDCS) has emerged as a non-invasive brain stimulation technique. Most studies show that anodal tDCS increases cortical excitability. However, this effect has been found to be highly variable.
OBJECTIVE


To test the effect of anodal tDCS on cortical excitability and the interaction effect of two participant-specific factors that may explain individual differences in sensitivity to anodal tDCS: the Brain Derived Neurotrophic Factor Val66Met polymorphism (BDNF genotype) and the latency difference between anterior-posterior and lateromedial TMS pulses (APLM latency).
METHODS


In 62 healthy participants, cortical excitability over the left motor cortex was measured before and after anodal tDCS at 2mA for 20 minutes in a pre-registered, double-blind, randomized, placebo-controlled trial with repeated measures.
RESULTS


We did not find a main effect of anodal tDCS, nor an interaction effect of the participant-specific predictors. Moreover, further analyses did not provide evidence for the existence of responders and non-responders.
CONCLUSION


This study indicates that anodal tDCS at 2mA for 20 minutes may not reliably affect cortical excitability.",2020,"We did not find a main effect of anodal tDCS, nor an interaction effect of the participant-specific predictors.",['62 healthy participants'],"['Transcranial direct current stimulation (tDCS', 'placebo', 'anodal tDCS']","['motor cortical excitability', 'cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",62.0,0.431948,"We did not find a main effect of anodal tDCS, nor an interaction effect of the participant-specific predictors.","[{'ForeName': 'Zeb D', 'Initials': 'ZD', 'LastName': 'Jonker', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands; Department of Rehabilitation Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands; Rijndam Rehabilitation, Rotterdam, the Netherlands.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Gaiser', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Joke H M', 'Initials': 'JHM', 'LastName': 'Tulen', 'Affiliation': 'Department of Psychiatry, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Gerard M', 'Initials': 'GM', 'LastName': 'Ribbers', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands; Rijndam Rehabilitation, Rotterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Frens', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Ruud W', 'Initials': 'RW', 'LastName': 'Selles', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands; Department of Plastic and Reconstructive Surgery, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address: r.selles@erasmusmc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.11.005']
2177,33197657,The effect of selenium and vitamin E supplementation on anti-Mullerian hormone and antral follicle count in infertile women with occult premature ovarian insufficiency: A randomized controlled clinical trial.,"OBJECTIVE


Increased accumulation of reactive oxygen species (ROS) in the process of oogenesis is one of the most well known causes of ovarian insufficiency and decreased ovarian reserve. Selenium and vitamin E as cofactors of glutathione peroxidase plays an important role in the removal of ROS in the ovary. We evaluated the effects of selenium and vitamin E supplementation on anti-Mullerian hormone (AMH) index and antral follicle count (AFC) (primary outcomes) and mean ovarian volume (MOV) and side effects of these supplements (secondary outcome) in infertile women with occult premature ovarian insufficiency (OPOI).
METHODS


70 patients were allocated into the control and treatment groups through block randomization method. 35 women in the treatment group received 200 ng selenium and 400IU vitamin E and 35 women in the control group received placebo for a total of 90 days. AMH index, AFC and mean ovarian volume (MOV) were investigated in both groups after 12 months of study.
RESULT


There was no significant difference between groups before intervention in AMH (Mean difference: -0.08; 95% CI: -0.20 to.08; p=0.33), AFC (-0.71; 95%CI: -1.44 to -0.01; p=0.05) and MOV (-0.55; 95% CI: -0.85 to -0.24; p=0.001). There was a significant increase in AMH (mean difference: 0.59; 95% CI: 0.48 to 0.71; p<0.001), AFC (5.08; 95% CI: 4.36 to 5.08; p<0.001) and MOV (2.17; 95% CI: 1.87 to 2.47; p<0.001) in selenium + vitamin E group compared to placebo group 12 months after intervention. These supplements had no side effects.
CONCLUSION


Supplementation with selenium and vitamin E can increase AMH, AFC and MOV in women with OPOI.",2020,"There was a significant increase in AMH (mean difference: 0.59; 95% CI: 0.48 to 0.71; p<0.001), AFC (5.08; 95% CI: 4.36 to 5.08; p<0.001) and MOV (2.17; 95% CI: 1.87 to 2.47; p<0.001) in selenium + vitamin E group compared to placebo group 12 months after intervention.","['women with OPOI', 'infertile women with occult premature ovarian insufficiency (OPOI', '70 patients', 'infertile women with occult premature ovarian insufficiency', '35 women']","['200\u202fng selenium and 400IU vitamin E', 'selenium and vitamin E supplementation', 'placebo', 'Selenium and vitamin E', 'selenium and vitamin E']","['AMH, AFC and MOV', 'AFC', 'anti-Mullerian hormone and antral follicle count', 'MOV', 'AMH', 'anti-Mullerian hormone (AMH) index and antral follicle count (AFC) (primary outcomes) and mean ovarian volume (MOV) and side effects', 'AMH index, AFC and mean ovarian volume (MOV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0066928', 'cui_str': 'Mullerian regression factor'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",70.0,0.542002,"There was a significant increase in AMH (mean difference: 0.59; 95% CI: 0.48 to 0.71; p<0.001), AFC (5.08; 95% CI: 4.36 to 5.08; p<0.001) and MOV (2.17; 95% CI: 1.87 to 2.47; p<0.001) in selenium + vitamin E group compared to placebo group 12 months after intervention.","[{'ForeName': 'Farhadi Dizaji', 'Initials': 'FD', 'LastName': 'Safiyeh', 'Affiliation': 'Department of midwifery, nursing and midwifery Faculty, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Mirghafourvand', 'Initials': 'M', 'LastName': 'Mojgan', 'Affiliation': 'Social Determinants of Health Research Center, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahabi', 'Initials': 'S', 'LastName': 'Parviz', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Alizadeh', 'Initials': 'MA', 'LastName': 'Sakineh', 'Affiliation': 'Department of midwifery, nursing and midwifery Faculty, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Sadeghzadeh Oskouei', 'Initials': 'SO', 'LastName': 'Behnaz', 'Affiliation': 'Department of midwifery, nursing and midwifery Faculty, Tabriz University of Medical sciences, Tabriz, Iran. Electronic address: repbio.sbmu@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102533']
2178,33197681,Effects of situational simulation and online first-aid training programs for nurses in general medical wards: A prospective study.,"BACKGROUND


To maintain patient safety, effective first-aid skills are necessary during emergencies. It is important to develop in-service education programs to equip clinical nurses with first-aid skills.
OBJECTIVES


This study explored the effects of first-aid skills and knowledge between situational simulation training and online teaching. It also examined the different effects of two training programs associated with nurses' baseline first-aid ability.
DESIGN


This was a randomized, single-blind controlled study.
SETTING


The study was conducted from December 15, 2016 to May 28, 2018, in the nursing department of a medical center in Taiwan.
PARTICIPANTS


Participants were 92 general ward nurses.
METHODS


Participants were randomly assigned to either a situational simulation training or an online teaching group. We used a first-aid knowledge test (FAKT) and a first-aid skills test (FAST) to measure the participants' learning outcomes after intervention and we did cost comparisons between groups.
RESULTS


There were no significant differences in the changes in FAKT and FAST scores after intervention between situational simulation training and online teaching groups (p = 0.76, p = 0.45). All the participants in both training programs showed improvements via increased scores on FAST (M ± SD = 35.27 ± 12.08 for online teaching, M ± SD = 36.08 ± 10.78 for situational simulation training) and FAKT (M ± SD = 21.09 ± 18.59 for online teaching, M ± SD = 23.39 ± 15.36 for situational simulation training). However, for the subgroup of participants who scored <75% on the FAST pretest, better improvements only occurred in the situational simulation training, but the situational simulation training program had higher costs than the online teaching program.
CONCLUSIONS


The improvement was greater in the situational simulation training group among nurses who could not exceed scores of 75% for first-aid skills. First-aid skill scores below 75% are likely a sign of nurses who need more assistance, discussion, and debriefing from situational simulation training.",2020,"There were no significant differences in the changes in FAKT and FAST scores after intervention between situational simulation training and online teaching groups (p = 0.76, p = 0.45).","['December 15, 2016 to May 28, 2018, in the nursing department of a medical center in Taiwan', 'Participants were 92 general ward nurses', 'Participants', 'nurses in general medical wards']","['situational simulation training or an online teaching group', 'situational simulation training', 'situational simulation and online first-aid training programs', 'situational simulation training and online teaching']",['changes in FAKT and FAST scores'],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",92.0,0.0213921,"There were no significant differences in the changes in FAKT and FAST scores after intervention between situational simulation training and online teaching groups (p = 0.76, p = 0.45).","[{'ForeName': 'Pei-Yin', 'Initials': 'PY', 'LastName': 'Hsieh', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Hsin-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Chin-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Research, National Taiwan University Hospital and National Taiwan University College of Medicine, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Chun-Yeuh', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Min-Ling', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Huey-Jiuan', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Jin-Shing', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taiwan.'}, {'ForeName': 'Fei-Hsiu', 'Initials': 'FH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan. Electronic address: hsiaofei@ntu.edu.tw.'}]",Nurse education today,['10.1016/j.nedt.2020.104621']
2179,33197808,A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty.,"BACKGROUND


Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce pain after orthopedic surgery. Currently, selective COX-2 inhibitors can provide effective pain reduction with less platelet inhibition compared with conventional NSAIDs. We aimed to compare the analgesic effect and perioperative blood loss (PBL) after total knee arthroplasty (TKA) between ketorolac and parecoxib administration.
METHODS


We conducted a prospective randomized controlled study of 100 unilateral TKAs. The ketorolac group of 50 patients received an intraoperative periarticular injection (PAI) with 100 mg of bupivacaine and 30 mg of ketorolac. Afterwards, 30 mg of ketorolac was intravenously injected every 12 h until 48 h. In the parecoxib group of 50 patients, 20 mg of parecoxib was added to PAI, and the first intravenous dose was 20 mg followed by 40 mg every 12 h. The primary outcomes were visual analog scales (VASs) of postoperative pain, amount of morphine consumption, PBL, and blood transfusion rate.
RESULTS


The ketorolac group had a significantly lower VAS pain score than the parecoxib group at 6 h after TKA (2.38 ± 2.52 vs. 4.12 ± 2.86, P < 0.01). Thereafter, the VAS of both groups and total morphine consumption at 24 and 48 h were comparable. The PBLs of the ketorolac and parecoxib groups were 529.72 ± 263.02 and 402.40 ± 191.47 ml, respectively (P = 0.01). However, the blood transfusion rates between groups were not different.
CONCLUSION


Parecoxib provides comparable analgesic effects to ketorolac. Additionally, perioperative use of parecoxib is safe and is associated with significantly less blood loss after TKA.",2020,The ketorolac group had a significantly lower VAS pain score than the parecoxib group at 6 h after TKA (2.38 ± ,"['early pain management after total knee arthroplasty', 'total knee arthroplasty (TKA', '100 unilateral TKAs']","['ketorolac', 'Parecoxib', 'ketorolac and parecoxib', 'parecoxib', 'intraoperative periarticular injection (PAI) with 100\xa0mg of bupivacaine and 30\xa0mg of ketorolac']","['total morphine consumption', 'visual analog scales (VASs) of postoperative pain, amount of morphine consumption, PBL, and blood transfusion rate', 'blood transfusion rates', 'VAS pain score', 'analgesic effects', 'analgesic effect and perioperative blood loss (PBL', 'blood loss']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",100.0,0.140792,The ketorolac group had a significantly lower VAS pain score than the parecoxib group at 6 h after TKA (2.38 ± ,"[{'ForeName': 'Artit', 'Initials': 'A', 'LastName': 'Laoruengthana', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Piti', 'Initials': 'P', 'LastName': 'Rattanaprichavej', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand. Electronic address: pitir@nu.ac.th.'}, {'ForeName': 'Kongpob', 'Initials': 'K', 'LastName': 'Reosanguanwong', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Bhuwad', 'Initials': 'B', 'LastName': 'Chinwatanawongwan', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Pariphat', 'Initials': 'P', 'LastName': 'Chompoonutprapa', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Pongpirul', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The Knee,['10.1016/j.knee.2020.10.005']
2180,33197917,"Effects of Dietary Self-Monitoring, Physical Activity, Liraglutide 3.0 mg, and Placebo on Weight Loss in the SCALE IBT Trial.","INTRODUCTION


Individuals who enroll in intensive behavioral therapy (IBT) programs are asked to make several lifestyle changes simultaneously. However, few studies have examined the relative effects of adherence to different treatment components on weight loss.
OBJECTIVE


This secondary analysis of the SCALE IBT trial assessed adherence to the medication regimen, dietary self-monitoring, and physical activity recommendations and their relative contributions to weight change in individuals with obesity who were provided with IBT combined with either liraglutide 3.0 mg or placebo.
METHODS


SCALE IBT was a double-blinded, multicenter, randomized controlled trial comparing 56-week weight losses in individuals with obesity who received liraglutide 3.0 mg (n = 142) or placebo (n = 140), as an adjunct to IBT. Adherence to dietary self-monitoring, physical activity, and medication usage (liraglutide or placebo) were measured during the 56-week treatment period. A regression model was used to estimate the relative contribution of adherence to each treatment component to weight loss at week 56.
RESULTS


The proportion of individuals who adhered to each intervention component decreased over time. Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of -7.2% (95% CI -10.4 to -4.0; p < 0.0001) and -2.0% (95% CI -3.2 to -0.8; p = 0.0009), respectively. Complete adherence to liraglutide predicted an additional weight loss of -6.5% (95% CI -10.2 to -2.9; p = 0.0005) relative to individuals who did not adhere to the medication regimen, while adherence to placebo did not have a statistically significant effect on weight loss (p = 0.33).
CONCLUSIONS


High adherence to dietary self-monitoring and use of liraglutide 3.0 mg was associated with clinically relevant weight loss with IBT and adjunctive pharmacotherapy. The effect of adherence to physical activity was significant but smaller.",2020,"Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of -7.2% (95% CI -10.4 to -4.0; p < 0.0001) and -2.0% (95% CI -3.2 to -0.8; p = 0.0009), respectively.","['3.0 mg (n = 142) or', 'individuals with obesity who were provided with IBT combined with either', 'individuals with obesity who received']","['Dietary Self-Monitoring, Physical Activity, Liraglutide 3.0 mg, and Placebo', 'dietary self-monitoring, physical activity, and medication usage (liraglutide or placebo', 'liraglutide', 'intensive behavioral therapy', 'placebo', 'liraglutide 3.0 mg or placebo']","['Weight Loss', 'additional weight loss', 'weight loss', 'adherence to physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.110795,"Compared with non-adherence, complete adherence to dietary self-monitoring and physical activity recommendations were associated with estimated weight changes of -7.2% (95% CI -10.4 to -4.0; p < 0.0001) and -2.0% (95% CI -3.2 to -0.8; p = 0.0009), respectively.","[{'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'Fabricatore', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Auerbach', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Endahl', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, Illinois, USA.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]",Obesity facts,['10.1159/000511130']
2181,33197941,Fine-needle aspiration of pancreatic cystic lesions: A randomized study comparing standard and flexible needles with long-term follow-up.,"BACKGROUND AND STUDY AIMS


Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, and a majority have low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of 3 FNA needles on diagnostic accuracy, clinical management, and ability to accrue fluid for tumor markers.
PATIENTS AND METHODS


A multicenter prospective trial randomized 250 patients with PCLs≥13mm to 19G Flex(2):19G(1):22G(1) needles with cross-over as repeated FNA procedures. Diagnostic accuracy established at 2-year follow-up with final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review.
RESULTS


Patients enrolled (36% symptomatic) with PCLs in head (44%), body (28%), and tail (26%). Percentage of cyst volume aspiration is 78% [72%-84%] for 19G Flex, 74% [64%-84%] for 22G, and 73% [63%-83%] for19G (p=.84). Successful FNA was significantly higher for 19G Flex (89% [82%-94%]) and 22G (82% [70%-90%]) compared to 19G (75% [63%-85%]) (p=0.02). Repeated FNA was required more frequently in head/uncinate lesions than body and tail (p<.01). Diagnostic accuracy of cyst aspirate was 84% [73%-91%] against histopathology at 2-year follow-up (n=79), and 77% [70%-83%] against consensus diagnosis among non-resective cases (n=171). Related serious adverse events occurred in 1.2% [0.2%-3.5%] of patients.
CONCLUSIONS


Our study results demonstrate a statistically significant difference among the three needles in overall success rate of aspiration, but not in percentage of cyst volume aspirated. Flexible needles may be particularly valuable in sampling cystic PCLs in head/uncinate of pancreas.",2020,Repeated FNA was required more frequently in head/uncinate lesions than body and tail (p<.01).,"['pancreatic cystic lesions', '250 patients with PCLs≥13mm to 19G Flex(2):19G(1):22G(1) needles with cross-over as repeated FNA procedures']","['fine-needle aspiration (FNA', 'FNA needles', 'standard and flexible needles with long-term follow-up', 'Fine-needle aspiration']","['Successful FNA', 'Diagnostic accuracy of cyst aspirate', 'serious adverse events', 'Percentage of cyst volume aspiration']","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470539', 'cui_str': '19G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0370199', 'cui_str': 'Specimen obtained by aspiration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]",250.0,0.0704194,Repeated FNA was required more frequently in head/uncinate lesions than body and tail (p<.01).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Al-Haddad', 'Affiliation': 'Indiana University School of Medicine, Division of Gastroenterology, Indianapolis, United States.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Gastroenterology, Jacksonville, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brugge', 'Affiliation': 'Mount Auburn Hospital, Gastroenterology, Cambridge, United States.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Lakhtakia', 'Affiliation': 'Asian Institute of Gastroenterology, Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Shanghai Changhai Hospital, Gastroenterology, Shanghai, China.'}, {'ForeName': 'Amrita', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Division of Digestive and Liver Diseases, Columbia Presbyterian, New York, New York, USA, Division of Digestive and Liver Diseases, New York, United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Pleskow', 'Affiliation': 'Beth Israel Deaconess Medical Center, Gastroenterology, Boston, United States.'}, {'ForeName': 'Cuong', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Mayo Clinic Scottsdale, USA, Mayo Clinic Scottsdale, Scottsdale, United States.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Pannala', 'Affiliation': 'Mayo Clinic Scottsdale, Division of Gastroenterology and Hepatology, Scottsdale, United States.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'DeWitt', 'Affiliation': 'Indiana University Medical Center, Gastroenterology and Hepatology, Indianapolis, United States.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Raimondo', 'Affiliation': 'Mayo Clinic, Gastroenterology & Hepatology, Jacksonville, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Woodward', 'Affiliation': 'Mayo Clinic, Gastroenterology and Hepatology, Jacksonville, United States.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Ramchandani', 'Affiliation': 'Asian Institute of Gastroenterology, Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Shanghai Changhai Hospital, Gastroenterology, Shanghai, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Changhai Hospital, The Second Military Medical University, Department of Gastroenterology, Shanghai, China.'}, {'ForeName': 'Douglas O', 'Initials': 'DO', 'LastName': 'Faigel', 'Affiliation': 'Mayo Clinic Scottsdale, Division of Gastroenterology and Hepatology, Scottsdale, United States.'}]",Endoscopy,['10.1055/a-1311-9927']
2182,33198226,Are Individuals with Low Trait Anxiety Better Suited to On-Call Work?,"Research has indicated that individuals with certain traits may be better suited to shiftwork and non-standard working arrangements. However, no research has investigated how individual differences impact on-call outcomes. As such, this study investigated the impact of trait anxiety on sleep and performance outcomes on-call. Seventy male participants (20-35 years) completed an adaptation night, a control night, and two on-call nights in a laboratory. Trait anxiety was determined using the State Trait Anxiety Inventory (STAI) X-2, and participants completed the STAI X-1 prior to bed each night to assess state anxiety. Sleep was measured using polysomnography and quantitative electroencephalographic analysis. Performance was assessed using a 10-min psychomotor vigilance task (PVT) performed each day at 0930, 1200, 1430 and 1700 h. Data pooled from three separate but inter-related studies was used for these analyses. Results indicated that the effects of trait anxiety on state anxiety, sleep and performance outcomes on-call were generally limited. These findings suggest that on-call outcomes are not negatively affected by higher levels of trait anxiety.",2020,"Results indicated that the effects of trait anxiety on state anxiety, sleep and performance outcomes on-call were generally limited.","['Seventy male participants (20-35 years) completed an adaptation night, a control night, and two on-call nights in a laboratory']",[],"['Sleep', 'Trait anxiety', 'trait anxiety', 'state anxiety, sleep and performance outcomes', 'State Trait Anxiety Inventory (STAI) X-2']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",70.0,0.0309333,"Results indicated that the effects of trait anxiety on state anxiety, sleep and performance outcomes on-call were generally limited.","[{'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Sprajcer', 'Affiliation': 'Appleton Institute, School of Health Medical and Applied Sciences, Central Queensland University, Wayville 5034, SA, Australia.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jay', 'Affiliation': 'Appleton Institute, School of Health Medical and Applied Sciences, Central Queensland University, Wayville 5034, SA, Australia.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Vincent', 'Affiliation': 'Appleton Institute, School of Health Medical and Applied Sciences, Central Queensland University, Wayville 5034, SA, Australia.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Australian Centre for Precision Health, University of South Australia, Adelaide 5000, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vakulin', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide 5042, SA, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Lack', 'Affiliation': 'Adelaide Institute for Sleep Health, College of Education, Psychology, and Social Work, Flinders University, Adelaide 5042, SA, Australia.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Ferguson', 'Affiliation': 'Appleton Institute, School of Health Medical and Applied Sciences, Central Queensland University, Wayville 5034, SA, Australia.'}]",Clocks & sleep,['10.3390/clockssleep2040035']
2183,33198319,Non-Linear Pharmacokinetics of Oral Roscovitine (Seliciclib) in Cystic Fibrosis Patients Chronically Infected with  Pseudomonas aeruginosa : A Study on Population Pharmacokinetics with Monte Carlo Simulations.,"Roscovitine (Seliciclib), a new protein kinase inhibitor, was administered orally to adult patients with cystic fibrosis for the first time in the ROSCO-CF trial, a dose-escalation, phase IIa, randomized, controlled trial. Extensive pharmacokinetic sampling was performed up to 12 h after the first oral dose. Roscovitine and its main metabolite M3 were quantified by liquid chromatography coupled with tandem mass spectrometry. The pharmacokinetics analyses were performed by non-linear mixed effects modelling. Monte Carlo simulations were performed to assess the impact of dose on the pharmacokinetics of oral roscovitine. Twenty-three patients received oral doses ranging from 200 to 800 mg of roscovitine and 138 data points were available for both roscovitine and M3 concentrations. The pharmacokinetics was best described by a two-compartment parent-metabolite model, with a complex saturable absorption process modelled as the sum of Gaussian inverse density functions. The Monte Carlo simulations showed a dose-dependent and saturable first-pass effect leading to pre-systemic formation of M3. The treatment with proton-pump inhibitors reduced the rate of absorption of oral roscovitine. The pharmacokinetics of oral roscovitine in adult patients with cystic fibrosis was non-linear and showed significant inter-individual variability. A repeat-dose study will be required to assess the inter-occasional variability of its pharmacokinetics.",2020,The pharmacokinetics of oral roscovitine in adult patients with cystic fibrosis was non-linear and showed significant inter-individual variability.,"['Cystic Fibrosis Patients', 'adult patients with cystic fibrosis', 'Chronically Infected with  Pseudomonas aeruginosa ']","['Roscovitine (Seliciclib', 'roscovitine', 'proton-pump inhibitors', 'Oral Roscovitine (Seliciclib', 'oral roscovitine']",['rate of absorption of oral roscovitine'],"[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]","[{'cui': 'C0536217', 'cui_str': '(2R)-2-((6-Benzylamino-9-(propan-2-yl)-9H-purin-2-yl)amino)butan-1-ol'}, {'cui': 'C1609861', 'cui_str': 'Seliciclib'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0536217', 'cui_str': '(2R)-2-((6-Benzylamino-9-(propan-2-yl)-9H-purin-2-yl)amino)butan-1-ol'}]",,0.0295561,The pharmacokinetics of oral roscovitine in adult patients with cystic fibrosis was non-linear and showed significant inter-individual variability.,"[{'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Leven', 'Affiliation': 'EA 3878, GETBO, Université de Bretagne Occidentale, F-29200 Brest, France.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Schutz', 'Affiliation': 'Univ Brest, INSERM, EFS, UMR 1078, GGB, F-29200 Brest, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Audrezet', 'Affiliation': 'Univ Brest, INSERM, EFS, UMR 1078, GGB, F-29200 Brest, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nowak', 'Affiliation': ""Centre d'Investigation Clinique, INSERM CIC-1412, Hôpital de la Cavale Blanche, CHRU Brest, 29609 Brest CEDEX, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Meijer', 'Affiliation': ""ManRos Therapeutics, Presqu'île de Perharidy, 29680 Roscoff, France.""}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Montier', 'Affiliation': 'Univ Brest, INSERM, EFS, UMR 1078, GGB, F-29200 Brest, France.'}]",Pharmaceutics,['10.3390/pharmaceutics12111087']
2184,33198432,Intraoperative aerosol box use: does an educational visual aid reduce contamination?,"Background


The aerosol box was rapidly developed and disseminated to minimize viral exposure during aerosolising procedures during the COVID-19 pandemic, yet users may not understand how to use and clean the device. This could potentially lead to increased viral exposure to subsequent patients and practitioners. We evaluated intraoperative contamination and aerosol box decontamination and the impact of a preoperative educational visual aid.
Methods


Using a double-blinded randomized design, forty-four anesthesiology trainees and faculty completed a simulated anesthetic case using an aerosol box contaminated with a fluorescent marker; half of the subjects received a visual aid prior to the simulation. Intraoperative contamination was evaluated at 10 standardized locations using an ultraviolet light. Next, subjects were instructed to clean the aerosol box for use on the next patient. Following cleaning, the box was evaluated for decontamination using an ultraviolet light.
Results


Median total contamination score was significantly reduced in the experimental group (5.0 vs 10.0, p<0.001). The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (p = .009).
Conclusions


The use of a visual aid significantly decreased intraoperative contamination and improved box cleaning. Despite these findings, a potentially clinically significant amount of viral exposure may exist. Thorough evaluation of the risks and benefits of the aerosol box should be completed prior to use. If an aerosol box is used, a visual aid should be considered to remind practitioners how to best use and clean the box.",2020,"The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (p = .009).
",[],[],"['intraoperative contamination and improved box cleaning', 'Intraoperative contamination', 'Median total contamination score']",[],[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0355304,"The aerosol box was completely cleaned by 36.4% of subjects in the experimental group compared to 4.5% in the control group (p = .009).
","[{'ForeName': 'Garrett W', 'Initials': 'GW', 'LastName': 'Burnett', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, 1450 Madison Avenue, New York NY 10029 USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, 1450 Madison Avenue, New York NY 10029 USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Fried', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, 1450 Madison Avenue, New York NY 10029 USA.'}, {'ForeName': 'Ronak S', 'Initials': 'RS', 'LastName': 'Shah', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, 1450 Madison Avenue, New York NY 10029 USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, 1450 Madison Avenue, New York NY 10029 USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Katz', 'Affiliation': 'Department of Anesthesiology, Perioperative & Pain Medicine, Icahn School of Medicine at Mount Sinai, 1450 Madison Avenue, New York NY 10029 USA.'}]",Korean journal of anesthesiology,['10.4097/kja.20511']
2185,33198491,Finerenone and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes.,"Background:  The FIDELIO-DKD trial evaluated the effect of the nonsteroidal, selective mineralocorticoid receptor antagonist finerenone on kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) with optimized renin-angiotensin system blockade. Compared with placebo, finerenone reduced the composite kidney and CV outcomes. We report the effect of finerenone on individual CV outcomes and in patients with and without history of atherosclerotic CV disease (CVD).  Methods:  This randomized, double-blind, placebo-controlled trial included patients with T2D and urine albumin-to-creatinine ratio 30-5000 mg/g and an estimated glomerular filtration rate (eGFR) ≥25-<75 mL/min/1.73 m 2 , treated with optimized renin-angiotensin system blockade. Patients with a history of heart failure with reduced ejection fraction were excluded. Patients were randomized 1:1 to receive finerenone or placebo. The composite CV outcome included time to CV death, myocardial infarction, stroke, or hospitalization for heart failure. Prespecified CV analyses included analyses of the components of this composite and outcomes according to CVD history at baseline.  Results:  Between September 2015 and June 2018, 13,911 patients were screened and 5674 were randomized; 45.9% of patients had CVD at baseline. Over a median follow-up of 2.6 years (interquartile range, 2.0-3.4 years), finerenone reduced the risk of the composite CV outcome compared with placebo (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.75-0.99; P=0.034), with no significant interaction between patients with and without CVD (HR, 0.85; 95% CI, 0.71-1.01 in patients with a history of CVD; HR, 0.86; 95% CI, 0.68-1.08 in patients without a history of CVD; P-value for interaction, 0.85). The incidence of treatment-emergent adverse events was similar between treatment arms, with a low incidence of hyperkalemia-related permanent treatment discontinuation (2.3% with finerenone vs 0.8% with placebo in patients with CVD and 2.2% with finerenone vs 1.0% with placebo in patients without CVD).  Conclusions:  Among patients with CKD and T2D, finerenone reduced incidence of the composite CV outcome, with no evidence of differences in treatment effect based on pre-existing CVD status.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT02540993 (Funded by Bayer AG).",2020,"The incidence of treatment-emergent adverse events was similar between treatment arms, with a low incidence of hyperkalemia-related permanent treatment discontinuation (2.3% with finerenone vs 0.8% with placebo in patients with CVD and 2.2% with finerenone vs 1.0% with placebo in patients without CVD).  ","['Results:  Between September 2015 and June 2018, 13,911 patients were screened and 5674 were randomized; 45.9% of patients had CVD at baseline', 'patients with and without history of atherosclerotic CV disease (CVD', 'patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) with optimized renin-angiotensin system blockade', 'patients with T2D and urine albumin-to-creatinine ratio 30-5000 mg/g and an estimated glomerular filtration rate (eGFR) ≥25-<75', 'Patients with a history of heart failure with reduced ejection fraction were excluded', 'Patients with Chronic Kidney Disease and Type 2 Diabetes']","['finerenone or placebo', 'placebo, finerenone', 'nonsteroidal, selective mineralocorticoid receptor antagonist finerenone', 'mL', 'placebo', 'finerenone']","['incidence of treatment-emergent adverse events', 'time to CV death, myocardial infarction, stroke, or hospitalization for heart failure', 'composite CV outcome', 'kidney and cardiovascular (CV) outcomes', 'hyperkalemia-related permanent treatment discontinuation', 'composite kidney and CV outcomes', 'Finerenone and Cardiovascular Outcomes', 'individual CV outcomes']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",13911.0,0.550217,"The incidence of treatment-emergent adverse events was similar between treatment arms, with a low incidence of hyperkalemia-related permanent treatment discontinuation (2.3% with finerenone vs 0.8% with placebo in patients with CVD and 2.2% with finerenone vs 1.0% with placebo in patients without CVD).  ","[{'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain; CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain; Faculty of Sport Sciences, European University of Madrid, Madrid, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schloemer', 'Affiliation': 'Research and Development, Statistics and Data Insights, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Tornus', 'Affiliation': 'Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.051898']
2186,33198514,Acute effect of bodyweight-based strength training on blood pressure of hypertensive older adults: A randomized crossover clinical trial.,"Background : Strength Training (ST) reduces the cardiovascular risk of hypertensive elderly people; however, there is a need for efficient and low-cost ST programs that aim to reduce blood pressure (BP) in elderly people with adherence and affectivity in this population.  Objective : Evaluate the acute effect on BP and satisfaction with the practice of bodyweight-based strength training (BWST) in hypertensive older adults.  Methods : Participants performed a BWST session and a control session (CS). The BWST consisted of six exercises, with three sets of 30 seconds. In the CS, no activity was performed. BP was measured before and at 0, 10, 20, and 30 minutes post-session. Participants' satisfaction was assessed.  Results : Eleven older adults (65.8 ± 4.6 years; 7 men) participated in the study. There was an increase ( p  = .028) in systolic BP immediately after BWST, returning to baseline values in the intervals 10, 20, and 30 post-section. In the CS there was an increase ( p  = .009) 30 minutes post-session compared to 20 minutes. Between sessions, a lower systolic BP was found in BWST (-6.54 ± 3.31;  p  = .048) 30 minutes post-sessions. For satisfaction, 82% of participants were ""totally satisfied"" with BWST.  Conclusion : The SBP is lower 30 minutes after BWST session than control session, and BWST promoted a pleasant affective response in hypertensive older adults.",2020,In the CS there was an increase ( p  = .009),"['hypertensive older adults', 'hypertensive elderly people', 'Eleven older adults (65.8\xa0±\xa04.6\xa0years; 7 men) participated in the study', 'elderly people with adherence and affectivity in this population']","[' : Strength Training (ST', 'BWST session and a control session (CS', 'bodyweight-based strength training (BWST', 'BWST', 'bodyweight-based strength training']","['lower systolic BP', 'systolic BP', 'blood pressure', 'blood pressure (BP', 'BP and satisfaction', 'pleasant affective response', 'BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",11.0,0.0316738,In the CS there was an increase ( p  = .009),"[{'ForeName': 'Adriano L da', 'Initials': 'ALD', 'LastName': 'Silva', 'Affiliation': 'Centro de Desportos, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Silas N', 'Initials': 'SN', 'LastName': 'de Oliveira', 'Affiliation': 'Laboratório de Biomecânica, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Bruno A', 'Initials': 'BA', 'LastName': 'Vieira', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Chayana', 'Initials': 'C', 'LastName': 'Leite', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Doglas M', 'Initials': 'DM', 'LastName': 'Martins', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Antônio R P', 'Initials': 'ARP', 'LastName': 'Moro', 'Affiliation': 'Laboratório de Biomecânica, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Aline M', 'Initials': 'AM', 'LastName': 'Gerage', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}, {'ForeName': 'Rodrigo S', 'Initials': 'RS', 'LastName': 'Delevatti', 'Affiliation': 'Grupo de Estudo e Pesquisa em Exercício Físico e Doenças Crônicas Não Transmissíveis, Universidade Federal de Santa Catarina , Florianópolis, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1847130']
2187,33198533,The Effects of Agency Assignment and Reference Point on Responses to COVID-19 Messages.,"As the COVID-19 pandemic poses severe threats to human life around the globe, effective risk messages are needed to warn the public and encourage recommended actions for avoiding infection, especially as steps are taken to ease physical restrictions and restart economies. The present study examines the effects of agency assignment and reference point on perceptions of SARS-CoV-2 threat and assesses key message responses, including psychological reactance, source derogation, counterarguing, and behavioral intentions. Participants ( N  = 207) were randomly assigned to one of four conditions crossing agency assignment (SARS-CoV-2/human) and reference point (self/self-other). Results show, relative to human agency, SARS-CoV-2 agency assignment generated significantly more psychological reactance in the form of greater perceptions of freedom threat, anger, and negative cognitions, as well as more source derogation and counterarguing. No significant effects were found for reference point, and the interaction between agency assignment and reference point was not significant. The study findings, limitations, and implications are discussed.",2020,"No significant effects were found for reference point, and the interaction between agency assignment and reference point was not significant.",['Participants ( N  =\xa0207'],[],"['psychological reactance, source derogation, counterarguing, and behavioral intentions', 'freedom threat, anger, and negative cognitions', 'psychological reactance']",[],[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",207.0,0.0160465,"No significant effects were found for reference point, and the interaction between agency assignment and reference point was not significant.","[{'ForeName': 'Haijing', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Communication, University of Oklahoma.'}, {'ForeName': 'Claude H', 'Initials': 'CH', 'LastName': 'Miller', 'Affiliation': 'Department of Communication, University of Oklahoma.'}]",Health communication,['10.1080/10410236.2020.1848066']
2188,33203426,Early palliative radiation versus observation for high-risk asymptomatic or minimally symptomatic bone metastases: study protocol for a randomized controlled trial.,"BACKGROUND


In patients with metastatic cancer, the bone is the third-most common site of involvement. Radiation to painful bone metastases results in high rates of pain control and is an integral part of bone metastases management. Up to one-third of inpatient consults are requested for painful bone metastases, and up to 60% of these patients had evidence of these lesions visible on prior imaging. Meanwhile recent advances have reduced potential side effects of radiation. Therefore, there is an opportunity to further improve outcomes for patients using prophylactic palliative radiation to manage asymptomatic bone metastases.
METHODS/STUDY DESIGN


In this trial, 74 patients with metastatic solid tumors and high-risk asymptomatic or minimally symptomatic bone metastases will be enrolled and randomized to early palliative radiation or standard of care. This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint. This endpoint was selected to encompass patient-centered outcomes that impact quality of life including pathologic fracture, spinal cord compression, and intervention with surgery or radiation. Secondary endpoints include hospitalizations, Bone Pain Index, pain-free survival, pain-related quality of life, and side effects of radiation therapy.
DISCUSSION


In this study, we propose a novel definition of high-risk bone metastases most likely to benefit from preventive radiation and use validated questionnaires to assess pain and impact on quality of life and health resource utilization. Observations from early patient enrollment have demonstrated robustness of the primary endpoint and need for minor modifications to Bone Pain Index and data collection for opioid use and hospitalizations. With increasing indications for radiation in the oligometastatic setting, this trial aims to improve patient-centered outcomes in the polymetastatic setting.
TRIAL REGISTRATION


ISRCTN Number/Clinical trials.gov, ID: NCT03523351 . Registered on 14 May 2018.",2020,"This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint.","['high-risk asymptomatic or minimally symptomatic bone metastases', '74 patients with metastatic solid tumors and high-risk asymptomatic or minimally symptomatic bone metastases', 'patients with metastatic cancer']","['Early palliative radiation versus observation', 'prophylactic palliative radiation']","['impact quality of life including pathologic fracture, spinal cord compression, and intervention with surgery or radiation', 'quality of life and health resource utilization', 'hospitalizations, Bone Pain Index, pain-free survival, pain-related quality of life, and side effects of radiation therapy']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016663', 'cui_str': 'Pathological fracture'}, {'cui': 'C0037926', 'cui_str': 'Spinal cord compression'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",74.0,0.216809,"This will be the first trial to assess the efficacy of prophylactic palliative radiation in preventing skeletal related events (SREs), the primary endpoint.","[{'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.'}, {'ForeName': 'Cory D', 'Initials': 'CD', 'LastName': 'Benjamin', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Doyle', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Barker', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Vaynrub', 'Affiliation': 'Department of Surgery, Orthopaedic Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'T Jonathan', 'Initials': 'TJ', 'LastName': 'Yang', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA. yangt@mskcc.org.'}, {'ForeName': 'Erin F', 'Initials': 'EF', 'LastName': 'Gillespie', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, 1275 York Ave, Box 22, New York, NY, 10065, USA. efgillespie@ucsd.edu.'}]",BMC cancer,['10.1186/s12885-020-07591-w']
2189,33203433,The RESPECT study: a feasibility randomised controlled trial of a sexual health promotion intervention for people with serious mental illness in community mental health services in the UK.,"BACKGROUND


People with serious mental illness (SMI) have sexual health needs but there is little evidence to inform effective interventions to address them. In fact, there are few studies that have addressed this topic for people with SMI outside USA and Brazil. Therefore, the aim of the study was to establish the acceptability and feasibility of a trial of a sexual health promotion intervention for people with SMI in the UK.
METHOD


The RESPECT study was a two-armed randomised controlled, open feasibility trial (RCT) comparing Sexual health promotion intervention (3 individual sessions of 1 h) (I) or treatment as usual (TAU) for adults aged 18 or over, with SMI, within community mental health services in four UK cities. The main outcome of interest was the percentage who consented to participate, and retained in each arm of the trial, retention for the intervention, and completeness of data collection. A nested qualitative study obtained the views of participants regarding the acceptability of the study using individual telephone interviews conducted by lived experience researchers.
RESULTS


Of a target sample of 100, a total of 72 people were enrolled in the trial over 12 months. Recruitment in the initial months was low and so an extension was granted. However this extension meant that the later recruited participants would only be followed up to the 3 month point. There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it. At three months, 81.9% (30 I; 29 TAU) and at 6 months, 76.3% (13 I and 16 TAU) completed the follow-up data collection. No adverse events were reported. There was good completeness of the data. The sexual health outcomes for the intervention group changed in favour of the intervention. Based on analysis of the qualitative interviews, the methods of recruitment, the quality of the participant information, the data collection, and the intervention were deemed to be acceptable to the participants (n = 22).
CONCLUSIONS


The target of 100 participants was not achieved within the study's timescale. However, effective strategies were identified that improved recruitment in the final few months. Retention rates and completeness of data in both groups indicate that it is acceptable and feasible to undertake a study promoting sexual health for people with SMI. A fully powered RCT is required to establish effectiveness of the intervention in adoption of safer sex.
STUDY REGISTRATION


ISRCTN Registry ISRCTN15747739 prospectively registered 5th July 2016.",2020,There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it.,"['people with serious mental illness in community mental health services in the UK', 'adults aged 18 or over, with SMI, within community mental health services in four UK cities', 'people with SMI in the UK', ""100 participants was not achieved within the study's timescale"", 'Of a target sample of 100', 'People with serious mental illness (SMI', 'people with SMI', '72 people were enrolled in the trial over 12\u2009months']","['Sexual health promotion intervention (3 individual sessions of 1\u2009h) (I) or treatment as usual (TAU', 'sexual health promotion intervention']","['sexual health outcomes', 'adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",72.0,0.101828,There was good retention in the intervention and the study as a whole; 77.8% of those allocated to intervention (n = 28) received it.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'School of Healthcare, Faculty of Medicine and Health, University of Leeds, Leeds, UK. e.c.hughes@leeds.ac.uk.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gascoyne', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Thirimon', 'Initials': 'T', 'LastName': 'Moe-Byrne', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Edmondson', 'Affiliation': 'Centre for Applied Research in Health, School of Human and Health Sciences, University of Huddersfield, Huddersfield, England.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Lottie', 'Initials': 'L', 'LastName': 'Millett', 'Affiliation': 'Division of Psychiatry, University College London, London, England.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Cournos', 'Affiliation': 'New York State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Dare', 'Affiliation': ', Experts by experience, England.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, England.'}, {'ForeName': 'Harminder Dosanjh', 'Initials': 'HD', 'LastName': 'Kaur', 'Affiliation': ', Experts by experience, England.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKinnon', 'Affiliation': 'New York State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mercer', 'Affiliation': 'Institute for Global Health, University College London, London, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'School of Health and Social Care, University of Essex, Colchester, England.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': ', Experts by experience, England.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Wainberg', 'Affiliation': 'New York State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}]",BMC public health,['10.1186/s12889-020-09661-x']
2190,33203440,CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Primary Objective: To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult survivors of Covid-19 related critical illness. Secondary objectives: To investigate whether remotely delivered EMDR can improve psychological outcome following Covid-19 related critical illness, specifically Post-Traumatic Stress Disorder (PTSD), anxiety and depression.
TRIAL DESIGN


This is a single centre, randomised controlled cohort feasibility trial.
PARTICIPANTS


Participants will be recruited following discharge from the Intensive Care Unit at University Hospital Southampton, United Kingdom. Eligible patients will have received mechanical ventilation for a minimum of 24 hours, tested Covid-19 positive by polymerase chain reaction, will be over the age of 18 years and have the capacity to provide informed consent. Patients will be excluded if they have pre-existing cognitive impairment, pre-existing psychotic diagnosis or are not expected to survive post-hospital discharge.
INTERVENTION AND COMPARATOR


Group one: patients in the control arm will receive their standard package of prescribed care, following discharge home from hospital. If they experience any adverse physical or psychological health-conditions, they will access care through the usual available channels. Group two: patients randomly allocated to the intervention arm will receive their standard package of prescribed care, following discharge home from hospital. In addition, they will be referred to the Intensive Psychological Therapies Service in Poole, United Kingdom. They will receive an online appointment within 12-weeks of discharge home from hospital. They will receive a maximum of eight, weekly sessions of EMDR, delivered by a trained psychological therapist, following the Recent Traumatic Episode Protocol (R-TEP). Appendices 1 and 2 of the attached trial protocol contain a detailed description of the R-TEP intervention, written in accordance with the Template for Intervention Description and Replication (TIDieR) checklist and guide.
MAIN OUTCOMES


The primary outcome from this trial will be feasibility. Feasibility will be determined by recruitment rates, expressed as a percentage of eligible patients approached, completion of the EMDR intervention, completion of final assessment at 6-months, incidence of attributable adverse events and protocol adherence by the psychological therapists. Secondary, exploratory outcomes will be assessed by comparison between the control and intervention groups at 6-months post-hospital discharge. Psychometric evaluation will consist of the PTSD Checklist-Civilian Version and Hospital Anxiety and Depression Scale. In addition, we will assess health-related quality of life using the EQ5D-5L, physical activity using wrist worn activity monitors and nutritional state using the Council of Nutrition Appetite Questionnaire.
RANDOMISATION


Consenting participants will be randomly allocated to intervention or usual care using an internet-based system (ALEA TM ). Participants will be randomly assigned, on a 1:1 ratio, to receive either standard care (control) or the standard care plus online EMDR R-TEP (Intervention) BLINDING (MASKING): Due to the nature of the intervention, participants cannot be blinded to group allocation. 6-month patient reported outcome measures will be completed using an online, electronic case report form. Group allocation will be masked during data analysis.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This is a feasibility study, the results of which will be used to power a definitive study if appropriate. We anticipate a 25% mortality /loss to follow-up. A total of 26 patients will be recruited to this study, 13 patients in each arm.
TRIAL STATUS


CovEMERALD opened to recruitment on 23 rd  September 2020 with an anticipated recruitment period of 6-months. We are using protocol version number 1.2 (1 st  June 2020) TRIAL REGISTRATION: CovEMERALD was registered on clinicaltrials.gov NCT04455360 on 2 nd  July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult survivors of Covid-19 related critical illness.","['CovEMERALD opened to recruitment on 23 rd  September 2020 with an anticipated recruitment period of 6-months', 'Participants will be recruited following discharge from the Intensive Care Unit at University Hospital Southampton, United Kingdom', '26 patients will be recruited to this study, 13 patients in each arm', 'adult survivors of Covid-19 related critical illness']","['standard care (control) or the standard care plus online EMDR R-TEP (Intervention', 'mechanical ventilation', 'intervention or usual care using an internet-based system (ALEA TM ', 'remotely delivered EMDR', 'protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention', 'remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness']","['PTSD Checklist-Civilian Version and Hospital Anxiety and Depression Scale', 'psychological outcome following Covid-19 related critical illness, specifically Post-Traumatic Stress Disorder (PTSD), anxiety and depression', '6-months post-hospital discharge', 'mortality /loss']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",26.0,0.211096,"To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult survivors of Covid-19 related critical illness.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rushbrook', 'Affiliation': 'Dorset Healthcare University NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Elan', 'Initials': 'E', 'LastName': 'Shapiro', 'Affiliation': 'Independent Consultant, Haifa, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grocott', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK. mike.grocott@soton.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cusack', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}]",Trials,['10.1186/s13063-020-04805-1']
2191,33203449,Digital crowdsourced intervention to promote HIV testing among MSM in China: study protocol for a cluster randomized controlled trial.,"BACKGROUND


Men who have sex with men (MSM) are an important HIV key population in China. However, HIV testing rates among MSM remain suboptimal. Digital crowdsourced media interventions may be a useful tool to reach this marginalized population. We define digital crowdsourced media as using social media, mobile phone applications, Internet, or other digital approaches to disseminate messages developed from crowdsourcing contests. The proposed cluster randomized controlled trial (RCT) study aims to assess the effectiveness of a digital crowdsourced intervention to increase HIV testing uptake and decrease risky sexual behaviors among Chinese MSM.
METHODS


A two-arm, cluster-randomized controlled trial will be implemented in eleven cities (ten clusters) in Shandong Province, China. Targeted study participants will be 250 MSM per arm and 50 participants per cluster. MSM who are 18 years old or above, live in the study city, have not been tested for HIV in the past 3 months, are not living with HIV or have never been tested for HIV, and are willing to provide informed consent will be enrolled. Participants will be recruited through banner advertisements on Blued, the largest gay dating app in China, and in-person at community-based organizations (CBOs). The intervention includes a series of crowdsourced intervention materials (24 images and four short videos about HIV testing and safe sexual behaviors) and HIV self-test services provided by the study team. The intervention was developed through a series of participatory crowdsourcing contests before this study. The self-test kits will be sent to the participants in the intervention group at the 2nd and 3rd follow-ups. Participants will be followed up quarterly during the 12-month period. The primary outcome will be self-reported HIV testing uptake at 12 months. Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma.
DISCUSSION


Innovative approaches to HIV testing among marginalized population are urgently needed. Through this cluster randomized controlled trial, we will evaluate the effectiveness of a digital crowdsourced intervention, improving HIV testing uptake among MSM and providing a resource in related public health fields.
TRIAL REGISTRATION


ChiCTR1900024350 . Registered on 6 July 2019.",2020,"Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma.
","['Participants will be recruited through banner advertisements on Blued, the largest gay dating app in China, and in-person at community-based organizations (CBOs', 'MSM who are 18\u2009years old or above, live in the study city', 'Men who have sex with men (MSM', 'eleven cities (ten clusters) in Shandong Province, China']","['Digital crowdsourced intervention', 'Digital crowdsourced media interventions', 'digital crowdsourced intervention', 'crowdsourced intervention materials (24 images and four short videos about HIV testing and safe sexual behaviors) and HIV self-test services']","['HIV testing uptake and decrease risky sexual behaviors', 'self-reported HIV testing uptake', 'changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma']","[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",,0.241441,"Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma.
","[{'ForeName': 'Ci', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Chapel Hill Project-China, No. 2 Lujing Road, Guangzhou, 510095, China.'}, {'ForeName': 'Xiaorun', 'Initials': 'X', 'LastName': 'Tao', 'Affiliation': 'Institution for AIDS/STD Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, 250014, Shandong, China.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Institution for AIDS/STD Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, 250014, Shandong, China.'}, {'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Institution for AIDS/STD Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, 250014, Shandong, China.'}, {'ForeName': 'Kedi', 'Initials': 'K', 'LastName': 'Jiao', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Zece', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Chuanxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yijun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Dianmin', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Institution for AIDS/STD Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, 250014, Shandong, China. dianminkang66@163.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China. weima@sdu.edu.cn.'}]",Trials,['10.1186/s13063-020-04860-8']
2192,33203627,Methotrexate and prednisolone study in erythema nodosum leprosum (MaPs in ENL) protocol: a double-blind randomised clinical trial.,"INTRODUCTION


Erythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the 'MTX and prednisolone study in ENL' (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL.
METHODS AND ANALYSIS


MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients' reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events.
ETHICS AND DISSEMINATION


Results will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.",2020,"METHODS AND ANALYSIS


MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal.","['Patients diagnosed with ENL who consent to participate', 'leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal', 'Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL']","['Methotrexate and prednisolone', 'Methotrexate (MTX', 'Thalidomide', 'MTX', 'prednisolone and thalidomide', 'thalidomide', 'placebo', 'MTX and prednisolone', 'oral corticosteroids', 'prednisolone']","['efficacy of MTX', 'morbidity and mortality', 'morbidity and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0343466', 'cui_str': 'Type 2 lepra reaction'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1265576', 'cui_str': 'Acute erythema'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.414145,"METHODS AND ANALYSIS


MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'de Barros', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK barbara.de-barros@lshtm.ac.uk.'}, {'ForeName': 'Saba M', 'Initials': 'SM', 'LastName': 'Lambert', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Vivek V', 'Initials': 'VV', 'LastName': 'Pai', 'Affiliation': 'Bombay Leprosy Project, Mumbai, India.'}, {'ForeName': 'Joydeepa', 'Initials': 'J', 'LastName': 'Darlong', 'Affiliation': 'The Leprosy Mission Trust India, New Delhi, Indonesia.'}, {'ForeName': 'Benjamin Jewel', 'Initials': 'BJ', 'LastName': 'Rozario', 'Affiliation': 'DBLM Hospital, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh.'}, {'ForeName': 'Medhi Denisa', 'Initials': 'MD', 'LastName': 'Alinda', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Airlangga, Dr Soetomo General Hospital, Surabaya, Jawa Timur, Indonesia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Sales', 'Affiliation': 'Leprosy Laboratory, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Shimelis', 'Initials': 'S', 'LastName': 'Doni', 'Affiliation': 'Clinical Research Department, ALERT Center, Addis Ababa, London, Ethiopia.'}, {'ForeName': 'Deanna A', 'Initials': 'DA', 'LastName': 'Hagge', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Shrestha', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'M Yulianto', 'Initials': 'MY', 'LastName': 'Listiawan', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Airlangga, Dr Soetomo General Hospital, Surabaya, Jawa Timur, Indonesia.'}, {'ForeName': 'Abeba M', 'Initials': 'AM', 'LastName': 'Yitaye', 'Affiliation': 'Clinical Research Department, ALERT Center, Addis Ababa, London, Ethiopia.'}, {'ForeName': 'Jose A C', 'Initials': 'JAC', 'LastName': 'Nery', 'Affiliation': 'Leprosy Laboratory, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Kapil D', 'Initials': 'KD', 'LastName': 'Neupane', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Vivianne L A', 'Initials': 'VLA', 'LastName': 'Dias', 'Affiliation': 'Leprosy Laboratory, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'C Ruth', 'Initials': 'CR', 'LastName': 'Butlin', 'Affiliation': 'DBLM Hospital, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Nicholls', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lockwood', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Walker', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037700']
2193,33203685,Completion rate and impact on physician-patient relationship of video consultations in medical oncology: a randomised controlled open-label trial.,"BACKGROUND


Mobile phone video call applications generally did not undergo testing in randomised controlled clinical trials prior to their implementation in patient care regarding the rate of successful patient visits and impact on the physician-patient relationship.
METHODS


The National Center for Tumour Diseases (NCT) MOBILE trial was a monocentric open-label randomised controlled clinical trial of patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics. 66 patients were 1:1 randomised to receive either a standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application. The primary outcome was feasibility defined as the proportion of patients successfully completing the first follow-up visit. Secondary outcomes included success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician-patient relationship.
FINDINGS


Success rate of the first follow-up visit in the intention-to-treat cohort was 87.9% (29 of 33) for in-person visits and 78.8% (26 of 33) for video calls (relative risk: RR 0.90, 95% CI 0.70 to 1.13, p=0.51). The most common reasons for failure were software incompatibility in the video call and no-show in the in-person visit arm. The success rate for further video visits was 91.7% (11 of 12). Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86). Physician-patient relationship quality mean scores assessed by a validated standardised questionnaire were higher in the video call arm (1.13-fold, p=0.02).
INTERPRETATION


Follow-up visits with the tested mobile phone video call application were feasible but software compatibility should be critically evaluated.
TRIAL REGISTRATION NUMBER


DRKS00015788.",2020,"Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86).","['medical oncology', '66 patients', 'patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics', 'The National Center for Tumour Diseases (NCT']",['standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application'],"['success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician-patient relationship', 'feasibility defined as the proportion of patients successfully completing the first follow-up visit', 'success rate for further video visits', 'total time spent and less direct costs']","[{'cui': 'C0025098', 'cui_str': 'Medical oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",66.0,0.20894,"Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walle', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany t.walle@dkfz-heidelberg.de.'}, {'ForeName': 'Erkin', 'Initials': 'E', 'LastName': 'Erdal', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Mühlsteffen', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Hans Martin', 'Initials': 'HM', 'LastName': 'Singh', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Editha', 'Initials': 'E', 'LastName': 'Gnutzmann', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grün', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Hofmann', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Bruno Christian', 'Initials': 'BC', 'LastName': 'Köhler', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Korell', 'Affiliation': 'Department of Hematology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Mavratzas', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mock', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Pixberg', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schult', 'Affiliation': 'Department of Hematology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Starke', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Steinebrunner', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Woydack', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Jäger', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Jakob N', 'Initials': 'JN', 'LastName': 'Kather', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Eva C', 'Initials': 'EC', 'LastName': 'Winkler', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}]",ESMO open,['10.1136/esmoopen-2020-000912']
2194,33203692,Genetic predictors of severe skin toxicity in stage III colon cancer patients treated with cetuximab: NCCTG N0147 (Alliance).,"BACKGROUND


Cetuximab, an epidermal growth factor receptor inhibitor used to treat multiple cancer types including colon cancer, causes severe skin toxicity in 5-20% of patients, leading to decreased quality of life and treatment delays. Our understanding of which patients have an increased risk of severe toxicities is limited. We conducted a genome-wide association study to identify germline variants predictive of cetuximab-induced severe skin toxicity.
METHODS


Our study included 1,209 stage III colon cancer patients randomized to receive cetuximab plus 5-fluorouracil and oxaliplatin as part of the NCCTG N0147 (Alliance) clinical trial. Skin toxicity outcomes were collected using the Common Toxicity Criteria for Adverse Events version 3.0. We performed genotyping, evaluating ~10 million genetic variants. We used logistic regression to evaluate the association of each genetic variant and severe (grade >3) skin toxicity, adjusting for age, sex, and genetic ancestry. Genome-wide significance was defined as p<5x10-8.
RESULTS


Participants were predominantly middle-aged white men; 20% (n=243) experienced severe skin toxicity. Two genetic variants in the retinoic acid receptor alpha (RARA) gene were significantly associated with severe skin toxicity (OR = 3.93, 95% CI 2.47-6.25; p<7.8x10-9). Functional annotations indicate these variants are in the RARA promoter. Additional significantly associated variants were identified in chromosome 2 intergenic regions.
CONCLUSIONS


Identified variants could represent a potential target for risk stratification of colon cancer patients receiving cetuximab.
IMPACT


Retinoids have shown promise in the treatment of cetuximab-induced skin toxicity, so follow-up work could evaluate whether individuals with the RARA variant would benefit from retinoid therapy.",2020,"Two genetic variants in the retinoic acid receptor alpha (RARA) gene were significantly associated with severe skin toxicity (OR = 3.93, 95% CI 2.47-6.25; p<7.8x10-9).","['stage III colon cancer patients treated with', 'colon cancer patients receiving cetuximab', '10 million genetic variants', '1,209 stage III colon cancer patients', 'Participants were predominantly middle-aged white men']","['cetuximab plus 5-fluorouracil and oxaliplatin', 'cetuximab: NCCTG']","['severe toxicities', 'severe skin toxicity', 'Skin toxicity outcomes']","[{'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0390605,"Two genetic variants in the retinoic acid receptor alpha (RARA) gene were significantly associated with severe skin toxicity (OR = 3.93, 95% CI 2.47-6.25; p<7.8x10-9).","[{'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Labadie', 'Affiliation': 'Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Tabitha A', 'Initials': 'TA', 'LastName': 'Harrison', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Banbury', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Jeroen R', 'Initials': 'JR', 'LastName': 'Huyghe', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'SDMC, NRG Oncology.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Medicine and Division of Oncology, Mayo Clinic.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'Medicine, The West Virginia University Cancer Institute.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'Department of Medicine, University of Florida.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Penney', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School.""}, {'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Phipps', 'Affiliation': 'Department of Epidemiology, University of Washington.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Cohen', 'Affiliation': 'Oncology, University of Washington.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Polly A', 'Initials': 'PA', 'LastName': 'Newcomb', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center pnewcomb@fredhutch.org.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-1274']
2195,33203708,Comparison of active versus passive surveillance adverse event reporting in a paediatric ambulatory chiropractic care setting: a cluster randomised controlled trial.,"OBJECTIVES


This pragmatic, cluster, stratified randomised controlled trial (RCT) compared the quantity and quality of adverse event (AE) reports after chiropractic manual therapy in children less than 14 years of age, using active versus passive surveillance reporting systems.
METHOD


Data were collected between November 2014 and July 2017 from 60 consecutive paediatric patient visits to participating chiropractors. Those allocated to active surveillance collected AE information with three paper-based questionnaires (two from patients, one from chiropractors) to identify any new or worsening symptoms after treatment. Passive surveillance involved AE information reported by chiropractors on a web-based system. To assess quality of reporting, AE reports greater than mild were reviewed by content experts. The primary outcome was the cumulative incidence of AE reports in active versus passive surveillance.
RESULTS


Ninety-six chiropractors agreed to participate and enrolled in the study: 34 chiropractors in active surveillance with 1894 patient visits from 1179 unique patients and 35 chiropractors in passive surveillance with 1992 patient visits from 1363 unique patients. In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001). The quality of AE reports was not evaluated because the five AE reports reviewed by the content experts were determined to be of mild severity.
CONCLUSION


We found that active surveillance resulted in significantly more AE reports than passive surveillance. Further prospective active surveillance research studies should be conducted with children receiving chiropractic manual therapy to understand mechanisms and risk factors for moderate and severe AEs, and to further explore how and when to solicit patient safety information.",2020,"In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001).","['Data were collected between November 2014 and July 2017 from 60 consecutive paediatric patient visits to participating chiropractors', 'paediatric ambulatory chiropractic care setting', 'children less than 14 years of age, using active versus passive surveillance reporting systems', 'Ninety-six chiropractors agreed to participate and enrolled in the study: 34 chiropractors in active surveillance with 1894 patient visits from 1179 unique patients and 35 chiropractors in passive surveillance with 1992 patient visits from 1363 unique patients', 'children receiving']",['chiropractic manual therapy'],"['cumulative incidence of AE reports in active versus passive surveillance', 'quantity and quality of adverse event (AE']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334952', 'cui_str': 'Chiropractor'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0456592', 'cui_str': '1992'}]","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.15357,"In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001).","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Pohlman', 'Affiliation': 'Research Center, Parker University, Dallas, Texas, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Carroll', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ross T', 'Initials': 'RT', 'LastName': 'Tsuyuki', 'Affiliation': 'Department of Pharmacology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartling', 'Affiliation': 'Department of Paediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Vohra', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada svohra@ualberta.ca.'}]",BMJ open quality,['10.1136/bmjoq-2020-000972']
2196,33198629,Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study.,"BACKGROUND


Cost-effectiveness studies on pacemakers have increased in the last years. However the number of long-term cost-utility studies is limited. The objective of this study was to perform a cost-utility analysis comparing remote monitoring (RM) versus conventional monitoring (CM) in hospital of older patients with pacemakers, 5 years after implant.
METHODS


Under a controlled, not randomized, nor masked clinical trial, 83 patients with pacemakers were initially selected. After five years of follow-up, a total of 55 patients (CM = 34; RM = 21) completed the study. A cost-utility analysis of RM in terms of costs per gained quality-adjusted life years (QALYs) was conducted. The costs from the Public Health System (PHS) as well as patients and their relatives were taken into account for the study. The robustness of the results was verified by the probabilistic analyses through Monte-Carlo simulations.
RESULTS


After a five-year follow-up period, total costs were lower in the RM group by 23.02% than in the CM group (€274.52 versus €356.62; p = 0.033) because of a cost saving from patients' perspective (€59.05 versus €102.98; p = 0.002). However, the reduction of in-hospital visits derived from RM exhibited insignificant impact on the costs from the PHS perspective, with a cost saving of 15.04% (€215.48 vs. €253.64; p = 0.144). Costs/QALYs obtained by the RM group were higher as compared to the CM group, although there were no significant differences. The incremental cost-effectiveness ratio of CM in comparison to RM became positive (€301.16).
CONCLUSIONS


This study confirms RM of older patients with pacemakers appears still as a cost-utility alternative to CM in hospital after 5 years of follow-up.
TRIAL REGISTRATION


ClinicalTrials.gov: (Identifier: NCT02234245 ). Registered 09 September 2014 - Prospectively registered.",2020,"After a five-year follow-up period, total costs were lower in the RM group by 23.02% than in the CM group (€274.52 versus €356.62; p = 0.033) because of a cost saving from patients' perspective (€59.05 versus €102.98; p = 0.002).","['hospital of older patients with pacemakers, 5\u2009years after implant', '83 patients with pacemakers were initially selected', 'older patients with pacemakers', 'Registered 09 September 2014 - Prospectively registered']",['remote monitoring (RM) versus conventional monitoring (CM'],"['incremental cost-effectiveness ratio of CM', 'total costs', 'Costs/QALYs']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",83.0,0.0340922,"After a five-year follow-up period, total costs were lower in the RM group by 23.02% than in the CM group (€274.52 versus €356.62; p = 0.033) because of a cost saving from patients' perspective (€59.05 versus €102.98; p = 0.002).","[{'ForeName': 'Rafael Jesus', 'Initials': 'RJ', 'LastName': 'Bautista-Mesa', 'Affiliation': 'Management Unit, Hospital de Poniente, El Ejido, Almeria, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Villegas', 'Affiliation': 'Social Involvement of Critical and Emergency Medicine, CTS-609 Research Group, Hospital de Poniente, El Ejido, s/n, 04700, Almeria, Spain. antoniolopezvillegas@andaluciajunta.es.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Peiro', 'Affiliation': 'Health Services Research Unit, FISABIO-PUBLIC HEALTH, Valencia, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catalan-Matamoros', 'Affiliation': 'Department of Communication Studies, University Carlos III of Madrid, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Robles-Musso', 'Affiliation': 'Pacemaker Unit, Intensive Care Unit, Hospital de Poniente, El Ejido, Almería, Spain.'}, {'ForeName': 'Remedios', 'Initials': 'R', 'LastName': 'Lopez-Liria', 'Affiliation': 'Department of Nursing Science, Physiotherapy and Medicine, Hum-498 Research Team, Health Research Centre, University of Almería, Almería, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leal-Costa', 'Affiliation': 'Nursing Department, University of Murcia, Murcia, Spain.'}]",BMC geriatrics,['10.1186/s12877-020-01883-3']
2197,33198634,Effect of a patient-centred deprescribing procedure in older multimorbid patients in Swiss primary care - A cluster-randomised clinical trial.,"BACKGROUND


Management of patients with polypharmacy is challenging, and evidence for beneficial effects of deprescribing interventions is mixed. This study aimed to investigate whether a patient-centred deprescribing intervention of PCPs results in a reduction of polypharmacy, without increasing the number of adverse disease events and reducing the quality of life, among their older multimorbid patients.
METHODS


This is a cluster-randomised clinical study among 46 primary care physicians (PCPs) with a 12 months follow-up. We randomised PCPs into an intervention and a control group. They recruited 128 and 206 patients if ≥60 years and taking ≥five drugs for ≥6 months. The intervention consisted of a 2-h training of PCPs, encouraging the use of a validated deprescribing-algorithm including shared-decision-making, in comparison to usual care. The primary outcome was the mean difference in the number of drugs per patient (dpp) between baseline and after 12 months. Additional outcomes focused on patient safety and quality of life (QoL) measures.
RESULTS


Three hundred thirty-four patients, mean [SD] age of 76.2 [8.5] years participated. The mean difference in the number of dpp between baseline and after 12 months was 0.379 in the intervention group (8.02 and 7.64; p = 0.059) and 0.374 in the control group (8.05 and 7.68; p = 0.065). The between-group comparison showed no significant difference at all time points, except for immediately after the intervention (p = 0.002). There were no significant differences concerning patient safety nor QoL measures.
CONCLUSION


Our straight-forward and patient-centred deprescribing procedure is effective immediately after the intervention, but not after 6 and 12 months. Further research needs to determine the optimal interval of repeated deprescribing interventions for a sustainable effect on polypharmacy at mid- and long-term. Integrating SDM in the deprescribing process is a key factor for success.
TRIAL REGISTRATION


Current Controlled Trials, prospectively registered ISRCTN16560559 Date assigned 31/10/2014. The Prevention of Polypharmacy in Primary Care Patients Trial (4P-RCT).",2020,The mean difference in the number of dpp between baseline and after 12 months was 0.379 in the intervention group (8.02 and 7.64; p = 0.059) and 0.374 in the control group (8.05 and 7.68; p = 0.065).,"['Three hundred thirty-four patients, mean [SD] age of 76.2 [8.5] years participated', '46 primary care physicians (PCPs) with a 12\u2009months follow-up', 'patients with polypharmacy', 'older multimorbid patients in Swiss primary care - A cluster', 'Primary Care Patients Trial', 'They recruited 128 and 206 patients if ≥60\u2009years and taking ≥five drugs for ≥6 months']",['patient-centred deprescribing procedure'],"['quality of life', 'patient safety nor QoL measures', 'mean difference in the number of drugs per patient (dpp', 'patient safety and quality of life (QoL) measures']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",334.0,0.1329,The mean difference in the number of dpp between baseline and after 12 months was 0.379 in the intervention group (8.02 and 7.64; p = 0.059) and 0.374 in the control group (8.05 and 7.68; p = 0.065).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zechmann', 'Affiliation': 'Institute of Primary Care, University of Zurich, University Hospital Zurich, Pestalozzistrasse 24, 8091, Zurich, Switzerland. stefan.zechmann@usz.ch.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Senn', 'Affiliation': 'Institute of Primary Care, University of Zurich, University Hospital Zurich, Pestalozzistrasse 24, 8091, Zurich, Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Valeri', 'Affiliation': 'Institute of Primary Care, University of Zurich, University Hospital Zurich, Pestalozzistrasse 24, 8091, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Essig', 'Affiliation': 'Institute of Primary and Community Care, Lucerne, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Merlo', 'Affiliation': 'Institute of Primary and Community Care, Lucerne, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, University Hospital Zurich, Pestalozzistrasse 24, 8091, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Neuner-Jehle', 'Affiliation': 'Institute of Primary Care, University of Zurich, University Hospital Zurich, Pestalozzistrasse 24, 8091, Zurich, Switzerland.'}]",BMC geriatrics,['10.1186/s12877-020-01870-8']
2198,33198652,Retrospective cohort study of nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab as second-line treatment in patients with advanced gastric cancer.,"BACKGROUND


Nanoparticle albumin-bound paclitaxel (nab-PTX) has shown non-inferiority to paclitaxel (PTX) as second-line therapy for advanced gastric cancer (AGC) with fewer infusion-related reactions. The efficacy and safety of nab-PTX plus ramucirumab (RAM) was reported in a phase II trial; however, there is no randomized trial comparing this regimen with PTX plus RAM in patients with AGC. This retrospective study aimed to investigate the efficacy and safety of nab-PTX plus RAM versus PTX plus RAM in patients with AGC.
METHODS


This study included patients with AGC who received nab-PTX plus RAM from September 2017 to January 2019 or PTX plus RAM from June 2015 to August 2017 as second-line chemotherapy in our hospital.
RESULTS


A total of 113 and 138 patients who received nab-PTX plus RAM and PTX plus RAM, respectively, were analyzed. Median progression-free survival (PFS) was 3.9 months (95% confidence interval [CI]: 3.4-4.3) in the nab-PTX plus RAM group and 3.9 months (95% CI: 3.1-4.7) in the PTX plus RAM group (hazard ratio [HR]: 1.08; 95% CI: 0.83-1.40; P = 0.573). Median overall survival (OS) was 10.9 months (95% CI: 9.3-12.7) in the nab-PTX plus RAM group and 10.3 months (95% CI: 8.5-12.0) in the PTX plus RAM group (hazard ratio: 0.82; 95% CI: 0.61-1.10; P = 0.188). In patients with moderate/massive ascites, favorable outcomes for progression-free survival were observed in the nab-PTX plus RAM group compared with the PTX plus RAM group. Although anemia and fatigue (any grade) were more frequent in the nab-PTX plus RAM group, discontinuation of study treatment was not increased in the nab-PTX plus RAM group. There was no occurrence of hypersensitivity reaction in the nab-PTX plus RAM group, while two patients (1.4%) experienced grade 3 hypersensitivity reactions in the PTX plus RAM group.
CONCLUSIONS


The combination of nab-PTX plus RAM showed a similar efficacy and safety profile to PTX plus RAM as second-line treatment for patients with AGC.",2020,Median overall survival (OS) was 10.9 months (95% CI: 9.3-12.7) in the nab-PTX plus RAM group and 10.3 months (95% CI: 8.5-12.0) in the PTX plus RAM group (hazard ratio: 0.82; 95% CI: 0.61-1.10; P = 0.188).,"['patients with AGC', 'A total of 113 and 138 patients who received', 'advanced gastric cancer (AGC', 'patients with advanced gastric cancer', 'patients with AGC who received nab-PTX plus RAM from September 2017 to January 2019 or PTX plus RAM from June 2015 to August 2017 as second-line chemotherapy in our hospital']","['PTX plus RAM', 'nanoparticle albumin-bound paclitaxel plus ramucirumab versus paclitaxel plus ramucirumab', 'nab-PTX plus RAM', 'nab-PTX plus RAM and PTX plus RAM', 'nab-PTX plus RAM versus PTX plus RAM', 'Nanoparticle albumin-bound paclitaxel (nab-PTX', 'paclitaxel (PTX', 'nab-PTX plus ramucirumab (RAM']","['Median overall survival (OS', 'efficacy and safety', 'Median progression-free survival (PFS', 'anemia and fatigue', 'progression-free survival', 'hypersensitivity reaction', 'grade 3 hypersensitivity reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",,0.0849588,Median overall survival (OS) was 10.9 months (95% CI: 9.3-12.7) in the nab-PTX plus RAM group and 10.3 months (95% CI: 8.5-12.0) in the PTX plus RAM group (hazard ratio: 0.82; 95% CI: 0.61-1.10; P = 0.188).,"[{'ForeName': 'Mashiro', 'Initials': 'M', 'LastName': 'Okunaka', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kotani', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. dkotani@east.ncc.go.jp.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Demachi', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kawazoe', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Toshikatsu', 'Initials': 'T', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Pharmacy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.'}]",BMC cancer,['10.1186/s12885-020-07614-6']
2199,33198657,Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: post-hoc analysis from a randomized controlled trial.,"BACKGROUND


It is widely acknowledged that HPV prophylactic vaccine could prevent new infections and their associated lesions among women who are predominantly HPV-naive at vaccination. Yet there still remains uncertainty about whether HPV vaccination could benefit to individuals who have undergone surgery for cervical disease.
METHODS


This post-hoc analysis intends to focus on intent-to-treat participants who underwent excision treatment at baseline and the follow-up period in a phase II/III, double-blind, randomized trial ( ClinicalTrials.gov , number NCT00779766 ) conducted in Jiangsu province, China. We evaluate the impact of HPV vaccination on preventing women from subsequent infection and cervical lesions (LSIL+ and CIN2+) after excision treatment.
RESULTS


One hundred sixty-eight (vaccine, n = 87; placebo, n = 81) performed excisional treatment in this clinical trial. We observed a significant effect of vaccination on acquiring 14 high-risk HPV (HR-HPV) infection after treatment (vaccine efficacy: 27.0%; 95% CI 4.9, 44.0%). The vaccine efficacy against new infections after treatment for 14 HR-HPV infection was estimated as 32.0% (95%CI 1.8, 52.8%), and was 41.2% (95%CI -162.7, 86.8%) for HPV16/18 infection. The accumulative clearance rates of the vaccine group and placebo group were 88.9 and 81.6% for HPV16/18 infection (P = 0.345), 63.4, 48.7% for 14 HR-HPV infection (P = 0.062), respectively. No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups.
CONCLUSIONS


No significant evidence from this study showed that HPV-16/18 AS04-adjuvanted vaccine could lead to viral faster clearance or have any effect on the rates of persistent infection among women who had excision treatment. However, the vaccine may still benefit post-treatment women with ""primary prophylactic"" effect. Further research is required in clarifying the effect of using the prophylactic HPV vaccine as therapeutic agents.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00779766 . Date and status of trial registration: October 24, 2008. Completed; Has Results.",2020,"No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups.
","['women from subsequent infection and cervical lesions (LSIL+ and CIN2+) after excision treatment', 'women who had excision treatment', 'One hundred sixty-eight (vaccine, n\u2009=\u200987', 'women who are predominantly HPV-naive at vaccination', 'individuals who have undergone surgery for cervical disease']","['placebo', 'HPV vaccination', 'HPV-16/18 AS04-adjuvanted vaccine', 'excisional treatment']","['14 high-risk HPV (HR-HPV) infection', 'persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL', 'accumulative clearance rates', 'subsequent infection and disease']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0235656', 'cui_str': 'Lesion of cervix'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007867', 'cui_str': 'Disorder of uterine cervix'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1302773', 'cui_str': 'Squamous intraepithelial neoplasia, low grade'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.611803,"No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, PO Box 2258, Beijing, 100021, China.'}, {'ForeName': 'Shangying', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, PO Box 2258, Beijing, 100021, China. shangyinghu@cicams.ac.cn.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, PO Box 2258, Beijing, 100021, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Cytology and Pathology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qinjing', 'Initials': 'Q', 'LastName': 'Pan', 'Affiliation': 'Department of Cytology and Pathology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, PO Box 2258, Beijing, 100021, China.'}, {'ForeName': 'Fanghui', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Department of Epidemiology, National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Panjiayuan Lane, PO Box 2258, Beijing, 100021, China. zhaofangh@cicams.ac.cn.'}]",BMC infectious diseases,['10.1186/s12879-020-05560-z']
2200,33198702,Association of changes in cardiorespiratory fitness with health-related quality of life in young adults with mobility disability: secondary analysis of a randomized controlled trial of mobile app versus supervised training.,"BACKGROUND


Young adults with mobility disability report lower health-related quality of life (HRQoL) than their able-bodied peers. This study aims to examine potential differences between the effects of mobile app versus supervised training and the association of cardiorespiratory fitness change with HRQoL in young adults with mobility disability.
METHODS


This is a secondary analysis of a parallel randomized controlled trial of a mobile app (n = 55) and a supervised health program (n = 55) that was provided for 12 weeks to 110 adults (18-45 years) with self-perceived mobility disability. Recruitment took place at rehabilitation centers in Stockholm, Sweden. Cardiorespiratory fitness was estimated from the results of a submaximal cycle ergometer test and HRQoL was assessed with the SF-36 questionnaire. Follow up was at 6 weeks, 12 weeks, and 1-year and all examinations were performed by blinded investigators. Between group differences of changes in HRQoL at follow up were estimated in intention-to-treat analysis using linear regression models. Crude and adjusted mixed-effects models estimated the associations between cardiorespiratory fitness change and HRQoL. Stratified analysis by intervention group was also performed.
RESULTS


In total, 40/55 from the mobile app group and 49/55 from the supervised training group were included in the intention to treat analysis. No significant differences were observed between the effects of the two interventions on HRQoL. In both crude and adjusted models, cardiorespiratory fitness change was associated with the general health (adjusted β = 1.30, 95% CI: 0.48, 2.13) and emotional role functioning (adjusted β = 1.18, 95% CI: 0.11, 2.25) domains of SF-36. After stratification, the associations with general health (adjusted β = 1.88, 95% CI: 0.87, 2.90) and emotional role functioning (adjusted β = 1.37, 95% CI: 0.18, 2.57) were present only in the supervised group.
CONCLUSION


This study found positive associations between cardiorespiratory fitness change and HRQoL in young adults with mobility disability who received supervised training. The effects of mobile app versus supervised training on HRQoL remain unclear.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) registry ISRCTN22387524 ; Prospectively registered on February 4th, 2018.",2020,This study found positive associations between cardiorespiratory fitness change and HRQoL in young adults with mobility disability who received supervised training.,"['young adults with mobility disability who received', 'young adults with mobility disability', 'Young adults with mobility disability report lower health-related quality of life (HRQoL) than their able-bodied peers']","['mobile app versus supervised training', 'mobile app (n\xa0=\u200955) and a supervised health program', 'supervised training']","['emotional role functioning', 'mobility disability', 'general health', 'Cardiorespiratory fitness', 'HRQoL']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.227628,This study found positive associations between cardiorespiratory fitness change and HRQoL in young adults with mobility disability who received supervised training.,"[{'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Lampousi', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. annamaria.lampousi@ki.se.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Berglind', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Forsell', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]",BMC public health,['10.1186/s12889-020-09830-y']
2201,33198710,"Crossed versus conventional pseudophakic monovision for high myopic eyes: a prospective, randomized pilot study.","BACKGROUND


Aiming at spectacle independence, conventional pseudophakic monovision has been widely used in myopia patients with bilateral monofocal intraocular lens implantation. However, the crossed monovision, which is to correct the dominant eye for near vision and the non-dominant eye for distant vision, has been mentioned preferable for high myopic cataract patients by some studies. We have conducted this study to compare clinical results to assess the feasibility of conventional and crossed monovision for high myopic pseudophakic patients by comparing patient satisfaction, visual function and spectacle independence.
METHOD


Forty-sixth high myopia patients were divided into two groups: 22 in crossed monovision group with patients whose refraction targeted to - 2.00 diopters (D) in the dominant eye and - 0.50D in the non-dominant eye; 24 in conventional monovision group with patients whose refraction targeted to - 0.50D in the dominant eye and - 2.00D in the non-dominant eye. Binocular uncorrected distance visual acuity (BUDVA), binocular uncorrected near visual acuity (BUNVA), binocular corrected distant visual acuity (BCDVA), binocular corrected near visual acuity (BCNVA), contrast visual acuity and stereoacuity were examined at postoperative 2 weeks, 1 month and 3 months. Questionnaires were completed by patients 3 months after binocular surgery to evaluate patients' satisfaction and spectacle independence.
RESULTS


The conventional monovision and the crossed monovision group showed no significant differences of mean BUDVA, BUNVA, BCDVA, BCNVA 2 weeks, 1 month or 3 months postoperatively (P > 0.05). There was no difference in the bilateral contrast sensitivity or stereoscopic function between the convention conventional and crossed monovision groups (P > 0.05). Patient satisfaction with near and distant vision, as well as spectacle dependence did not differ significantly between the two groups (P > 0.05).
CONCLUSION


Crossed pseudophakic monovision exhibited similar visual function when compared with conventional monovision technique, which indicates that it is an effective option to improve the visual functionality and quality of life for high myopic patients who considering bilateral cataract surgery.
TRIAL REGISTRATION


The Institutional Review Board and Ethics committee of the First Affiliated Hospital of Chongqing Medical University, Chongqing, China. The trial registration was submitted in September 2018 and passed on March 18, 2020, and the registration number is: ChiCTR2000030935 .",2020,There was no difference in the bilateral contrast sensitivity or stereoscopic function between the convention conventional and crossed monovision groups (P > 0.05).,"['high myopic patients who considering bilateral cataract surgery', 'Forty-sixth high myopia patients', 'myopia patients with bilateral monofocal intraocular lens implantation']","['conventional and crossed monovision', 'conventional pseudophakic monovision', 'crossed monovision group with patients whose refraction targeted to -\u20092.00 diopters (D) in the dominant eye and\u2009-\u20090.50D in the non-dominant eye; 24 in conventional monovision group with patients whose refraction targeted to -\u20090.50D in the dominant eye and\u2009-\u20092.00D in the non-dominant eye']","['visual functionality and quality of life', 'bilateral contrast sensitivity or stereoscopic function', 'mean BUDVA, BUNVA, BCDVA, BCNVA', 'Binocular uncorrected distance visual acuity (BUDVA), binocular uncorrected near visual acuity (BUNVA), binocular corrected distant visual acuity (BCDVA), binocular corrected near visual acuity (BCNVA), contrast visual acuity and stereoacuity', 'Patient satisfaction with near and distant vision']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0271183', 'cui_str': 'Severe myopia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042797', 'cui_str': 'Monocular vision'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",,0.0820335,There was no difference in the bilateral contrast sensitivity or stereoscopic function between the convention conventional and crossed monovision groups (P > 0.05).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xun', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400000, P.R. China.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400000, P.R. China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400000, P.R. China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400000, P.R. China. 42222@qq.com.'}]",BMC ophthalmology,['10.1186/s12886-020-01694-5']
2202,33198711,A randomized controlled trial to improve psychological detachment from work and well-being among employees: a study protocol comparing online CBT-based and mindfulness interventions.,"BACKGROUND


The changing landscape of the work environment, which often encompasses expectations of employees being continuously available, makes it difficult to disengage from work and recover. This can have a negative impact on employees' well-being, resulting in burnout, depression and anxiety, among other difficulties. The current study will test the effectiveness of two different online interventions (i.e., cognitive behavioral therapy; CBT and mindfulness-based stress reduction; MBSR) on employees' psychological detachment, burnout and other variables related to general (e.g., life satisfaction) and work-specific (e.g., work engagement) well-being.
METHODS/DESIGN


The study is designed as a randomized control trial with two intervention groups (i.e., CBT, MBSR) and a waitlist control group. Participants will be full-time employees from a wide range of organizations from Slovenia, who report moderate difficulties with psychological detachment from work and burnout and are not receiving any other form of treatment. The online interventions will encompass 12 sessions over 6 weeks (2 sessions per week); each session will include 1) an active audio-guided session and 2) home assignments, accompanied by handouts and worksheets. The study outcomes (i.e., psychological detachment, burnout, general and work-specific well-being), potential mechanisms (i.e., work-related maladaptive thinking patterns, mindfulness) and moderators (e.g., supervisor support for recovery) will be assessed immediately before and after the interventions (pre and post measurement) and 3 months after intervention completion (follow-up). Additionally, participants will fill out questionnaires for the assessment of the central mechanisms and study outcomes each week.
DISCUSSION


We expect that the CBT-based intervention will lead to greater improvements in psychological detachment from work and burnout compared to the MBSR and the waitlist control group. Additionally, we expect that the CBT-based intervention will also lead to greater enhancement of both general and work-related well-being.
TRIAL REGISTRATION


https://doi.org/10.1186/ISRCTN98347361 [May 19, 2020].",2020,We expect that the CBT-based intervention will lead to greater improvements in psychological detachment from work and burnout compared to the MBSR and the waitlist control group.,"['Participants will be full-time employees from a wide range of organizations from Slovenia, who report moderate difficulties with psychological detachment from work and burnout and are not receiving any other form of treatment', 'employees']","['online interventions (i.e., cognitive behavioral therapy; CBT and mindfulness-based stress reduction; MBSR', 'online CBT-based and mindfulness interventions']","['psychological detachment, burnout, general and work-specific well-being), potential mechanisms (i.e., work-related maladaptive thinking patterns, mindfulness) and moderators (e.g., supervisor support for recovery']","[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.0282175,We expect that the CBT-based intervention will lead to greater improvements in psychological detachment from work and burnout compared to the MBSR and the waitlist control group.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tement', 'Affiliation': 'Department of Psychology, University of Maribor, Faculty of Arts, Koroska 160, SI-2000, Maribor, Slovenia. sara.tement@um.si.'}, {'ForeName': 'Saša', 'Initials': 'S', 'LastName': 'Zorjan', 'Affiliation': 'Department of Psychology, University of Maribor, Faculty of Arts, Koroska 160, SI-2000, Maribor, Slovenia.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Lavrič', 'Affiliation': 'Slovene Centre for Suicide Research, University of Primorska, Andrej Marušič Institute, Koper, Slovenia.'}, {'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Poštuvan', 'Affiliation': 'Slovene Centre for Suicide Research, University of Primorska, Andrej Marušič Institute, Koper, Slovenia.'}, {'ForeName': 'Nejc', 'Initials': 'N', 'LastName': 'Plohl', 'Affiliation': 'Department of Psychology, University of Maribor, Faculty of Arts, Koroska 160, SI-2000, Maribor, Slovenia.'}]",BMC public health,['10.1186/s12889-020-09691-5']
2203,33198715,Effect of nutrition education on iodine deficiency disorders and iodized salt intake in south west Ethiopian women: a cluster randomized controlled trial.,"BACKGROUND


Although iodine nutrition status is improving globally, the progress is not uniform throughout the world due to several factors. Among these, poor knowledge, negative attitude and improper practice of iodized salt are the main risk factors for poor iodine nutrition in Ethiopia. This study was aimed to assess the effect of nutrition education intervention on knowledge, attitude and practice (KAP) of iodine deficiency and iodized salt utilization.
METHODS


A cluster randomized controlled trial was carried out among 652 women of reproductive age group in southwest Ethiopia. A total of 24 clusters were selected and randomized in to an intervention and control villages. Women in the intervention village received iodine nutrition related education for 6 months; while those in the control village did not receive any education. Baseline and endline data were collected from both groups. Generalized Estimating Equations (GEE) was used to determine the effect of intervention.
RESULTS


A total of 647 (99.2%) participants were successfully involved in the study. In the intervention group the median attendance was 10 out of 12 sessions. Women in the intervention group had shown statistically significant change in knowledge, attitude and practice scores as compared to control one. In multivariable GEE linear model, after adjusting for other background characteristics, the mean difference (95% CI) scores were 8.81 (8.46, 9.16) for knowledge, 3.35 (3.17, 3.54) for attitude and 2.90 (2.74, 3.05) for practice in the intervention arm.
CONCLUSIONS


Well designed and community-based iodine nutrition education is an effective strategy to improve the KAP of iodine deficiency disorders and iodized salt utilization. Trial registration PACTR201809544276357 (Retrospectively registered on 14, Sept. 2018). https://www.pactr.org .",2020,Well designed and community-based iodine nutrition education is an effective strategy to improve the KAP of iodine deficiency disorders and iodized salt utilization.,"['south west Ethiopian women', '652 women of reproductive age group in southwest Ethiopia', 'A total of 24 clusters', 'A total of 647 (99.2%) participants were successfully involved in the study']","['nutrition education', 'nutrition education intervention', 'iodine nutrition related education for 6\xa0months; while those in the control village did not receive any education']","['median attendance', 'knowledge, attitude and practice scores', 'knowledge, attitude and practice (KAP', 'iodine deficiency disorders and iodized salt intake']","[{'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4759669', 'cui_str': 'Iodine deficiency'}, {'cui': 'C0063758', 'cui_str': 'Iodized salt'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",24.0,0.0664205,Well designed and community-based iodine nutrition education is an effective strategy to improve the KAP of iodine deficiency disorders and iodized salt utilization.,"[{'ForeName': 'Agize', 'Initials': 'A', 'LastName': 'Asfaw', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Wolkite University, P.O. Box 07, Gubre, Ethiopia. agisha238@gmail.com.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Department of Nutrition and Dietetics, Faculty of Public Health, Jimma University, P.O. Box 378, Jimma, Ethiopia.'}, {'ForeName': 'Taye', 'Initials': 'T', 'LastName': 'Gari', 'Affiliation': 'Department of Public Health and Environmental Sciences, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia.'}]",BMC women's health,['10.1186/s12905-020-01126-y']
2204,33198777,A prognostic model for elderly patients with squamous non-small cell lung cancer: a population-based study.,"BACKGROUND


Squamous cell carcinoma (SCC) is a main pathological type of non-small cell lung cancer. It is common among elderly patients with poor prognosis. We aimed to establish an accurate nomogram to predict survival for elderly patients (≥ 60 years old) with SCC based on the Surveillance, Epidemiology, and End Results (SEER) database.
METHODS


The gerontal patients diagnosed with SCC from 2010 to 2015 were collected from the Surveillance, Epidemiology, and End Results (SEER) database. The independent prognostic factors were identified using multivariate Cox proportional hazards regression analysis, which were utilized to conduct a nomogram for predicting survival. The novel nomogram was evaluated by Concordance index (C-index), calibration curves, net reclassification improvement (NRI), integrated discrimination improvement (IDI), and decision curve analysis (DCA).
RESULTS


32,474 elderly SCC patients were included in the analysis, who were randomly assigned to training cohort (n = 22,732) and validation cohort (n = 9742). The following factors were contained in the final prognostic model: age, sex, race, marital status, tumor site, AJCC stage, surgery, radiation and chemotherapy. Compared to AJCC stage, the novel nomogram exhibited better performance: C-index (training group: 0.789 vs. 0.730, validation group: 0.791 vs. 0.733), the areas under the receiver operating characteristic curve of the training set (1-year AUC: 0.846 vs. 0.791, 3-year AUC: 0.860 vs. 0.801, 5-year AUC: 0.859 vs. 0.794) and the validation set (1-year AUC: 0.846 vs. 0.793, 3-year AUC: 0.863 vs. 0.806, 5-year AUC: 0.866 vs. 0.801), and the 1-, 3- and 5-year calibration plots. Additionally, the NRI and IDI and 1-, 3- and 5-year DCA curves all confirmed that the nomogram was a great prognosis tool.
CONCLUSIONS


We constructed a novel nomogram that could be practical and helpful for precise evaluation of elderly SCC patient prognosis, thus helping clinicians in determining the appropriate therapy strategies for individual SCC patients.",2020,"Compared to AJCC stage, the novel nomogram exhibited better performance: C-index (training group: 0.789 vs. 0.730, validation group: 0.791 vs. 0.733), the areas under the receiver operating characteristic curve of the training set (1-year AUC: 0.846 vs. 0.791, 3-year AUC: 0.860 vs. 0.801, 5-year AUC: 0.859 vs. 0.794) and the validation set (1-year AUC: 0.846 vs. 0.793, 3-year AUC: 0.863 vs. 0.806, 5-year AUC: 0.866 vs. 0.801), and the 1-, 3- and 5-year calibration plots.","['elderly patients with poor prognosis', 'elderly patients (≥\u200960\xa0years old) with SCC based on the Surveillance, Epidemiology, and End Results (SEER) database', '32,474 elderly SCC patients', 'gerontal patients diagnosed with SCC from 2010 to 2015 were collected from the Surveillance, Epidemiology, and End Results (SEER) database', 'elderly patients with squamous non-small cell lung cancer', 'individual SCC patients', 'Squamous cell carcinoma (SCC']",[],"['Concordance index (C-index), calibration curves, net reclassification improvement (NRI), integrated discrimination improvement (IDI), and decision curve analysis (DCA', 'NRI and IDI and 1-, 3- and 5-year DCA curves']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}]",32474.0,0.0343165,"Compared to AJCC stage, the novel nomogram exhibited better performance: C-index (training group: 0.789 vs. 0.730, validation group: 0.791 vs. 0.733), the areas under the receiver operating characteristic curve of the training set (1-year AUC: 0.846 vs. 0.791, 3-year AUC: 0.860 vs. 0.801, 5-year AUC: 0.859 vs. 0.794) and the validation set (1-year AUC: 0.846 vs. 0.793, 3-year AUC: 0.863 vs. 0.806, 5-year AUC: 0.866 vs. 0.801), and the 1-, 3- and 5-year calibration plots.","[{'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 of Yanta West Road, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 of Yanta West Road, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 of Yanta West Road, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 of Yanta West Road, Xi'an, 710061, Shaanxi, China.""}, {'ForeName': 'Haisheng', 'Initials': 'H', 'LastName': 'You', 'Affiliation': ""Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 of Yanta West Road, Xi'an, 710061, Shaanxi, China. haishengyou77@163.com.""}, {'ForeName': 'Yalin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Pharmacy, The First Affiliated Hospital of Xi'an Jiaotong University, No. 277 of Yanta West Road, Xi'an, 710061, Shaanxi, China. dongyalin@mail.xjtu.edu.cn.""}]",Journal of translational medicine,['10.1186/s12967-020-02606-3']
2205,33198820,DNA methylation signature in blood mirrors successful weight-loss during lifestyle interventions: the CENTRAL trial.,"BACKGROUND


One of the major challenges in obesity treatment is to explain the high variability in the individual's response to specific dietary and physical activity interventions. With this study, we tested the hypothesis that specific DNA methylation changes reflect individual responsiveness to lifestyle intervention and may serve as epigenetic predictors for a successful weight-loss.
METHODS


We conducted an explorative genome-wide DNA methylation analysis in blood samples from 120 subjects (90% men, mean ± SD age = 49 ± 9 years, body mass-index (BMI) = 30.2 ± 3.3 kg/m 2 ) from the 18-month CENTRAL randomized controlled trial who underwent either Mediterranean/low-carbohydrate or low-fat diet with or without physical activity.
RESULTS


Analyses comparing male subjects with the most prominent body weight-loss (responders, mean weight change - 16%) vs. non-responders (+ 2.4%) (N = 10 each) revealed significant variation in DNA methylation of several genes including LRRC27, CRISP2, and SLFN12 (all adj. P < 1 × 10 -5 ). Gene ontology analysis indicated that biological processes such as cell adhesion and molecular functions such as calcium ion binding could have an important role in determining the success of interventional therapies in obesity. Epigenome-wide association for relative weight-loss (%) identified 15 CpGs being negatively correlated with weight change after intervention (all combined P < 1 × 10 - 4 ) including new and also known obesity candidates such as NUDT3 and NCOR2. A baseline DNA methylation score better predicted successful weight-loss [area under the curve (AUC) receiver operating characteristic (ROC) = 0.95-1.0] than predictors such as age and BMI (AUC ROC = 0.56).
CONCLUSIONS


Body weight-loss following 18-month lifestyle intervention is associated with specific methylation signatures. Moreover, methylation differences in the identified genes could serve as prognostic biomarkers to predict a successful weight-loss therapy and thus contribute to advances in patient-tailored obesity treatment.",2020,Epigenome-wide association for relative weight-loss (%) identified 15 CpGs being negatively correlated with weight change after intervention (all combined P < 1 × 10 - 4 ) including new and also known obesity candidates such as NUDT3 and NCOR2.,"['120 subjects (90% men, mean\u2009±\u2009SD age\u2009=\u200949\u2009±\u20099\u2009years, body mass-index (BMI)\u2009=\u200930.2\u2009±\u20093.3\u2009kg/m 2 ']",['Mediterranean/low-carbohydrate or low-fat diet with or without physical activity'],"['relative weight-loss', 'successful weight-loss [area under the curve (AUC) receiver operating characteristic (ROC', 'body weight-loss', 'weight change', 'DNA methylation of several genes including LRRC27, CRISP2, and SLFN12']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",120.0,0.0279368,Epigenome-wide association for relative weight-loss (%) identified 15 CpGs being negatively correlated with weight change after intervention (all combined P < 1 × 10 - 4 ) including new and also known obesity candidates such as NUDT3 and NCOR2.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Keller', 'Affiliation': 'Helmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG) of the Helmholtz Center Munich at the University of Leipzig and University Hospital Leipzig, 04103, Leipzig, Germany.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, P.O.Box 653, 84105, Beer Sheva, Israel.'}, {'ForeName': 'Stephan H', 'Initials': 'SH', 'LastName': 'Bernhart', 'Affiliation': 'Interdisciplinary Center for Bioinformatics, University of Leipzig, 04107, Leipzig, Germany.'}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, P.O.Box 653, 84105, Beer Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Soroka University Medical Center, 84101, Beer-Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Schwarzfuchs', 'Affiliation': 'Soroka University Medical Center, 84101, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, P.O.Box 653, 84105, Beer Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, P.O.Box 653, 84105, Beer Sheva, Israel.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Hopp', 'Affiliation': 'Interdisciplinary Center for Bioinformatics, University of Leipzig, 04107, Leipzig, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'Medical Department III - Endocrinology, Nephrology, Rheumatology, University of Leipzig Medical Center, 04103, Leipzig, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Rohde', 'Affiliation': 'Helmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG) of the Helmholtz Center Munich at the University of Leipzig and University Hospital Leipzig, 04103, Leipzig, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Böttcher', 'Affiliation': 'IFB Adiposity Diseases, University of Leipzig, Liebigstrasse 19-21, 04103, Leipzig, Germany.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Stadler', 'Affiliation': 'Bioinformatics Group, Department of Computer Science, University of Leipzig, 04107, Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Helmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG) of the Helmholtz Center Munich at the University of Leipzig and University Hospital Leipzig, 04103, Leipzig, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Helmholtz Institute for Metabolic, Obesity and Vascular Research (HI-MAG) of the Helmholtz Center Munich at the University of Leipzig and University Hospital Leipzig, 04103, Leipzig, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kovacs', 'Affiliation': 'Medical Department III - Endocrinology, Nephrology, Rheumatology, University of Leipzig Medical Center, 04103, Leipzig, Germany. peter.kovacs@medizin.uni-leipzig.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, P.O.Box 653, 84105, Beer Sheva, Israel. irish@bgu.ac.il.'}]",Genome medicine,['10.1186/s13073-020-00794-7']
2206,33198837,Randomized Controlled Trial of Point-of-Care Ultrasound Education for the Recognition of Tension Pneumothorax by Paramedics in Prehospital Simulation.,"OBJECTIVE


The primary goal of this study was to determine if ultrasound (US) use after brief point-of-care ultrasound (POCUS) training on cardiac and lung exams would result in more paramedics correctly identifying a tension pneumothorax (TPTX) during a simulation scenario.
METHODS


A randomized controlled, simulation-based trial of POCUS lung exam education investigating the ability of paramedics to correctly diagnose TPTX was performed. The US intervention group received a 30-minute cardiac and lung POCUS lecture followed by hands-on US training. The control group did not receive any POCUS training. Both groups participated in two scenarios: right unilateral TPTX and undifferentiated shock (no TPTX). In both scenarios, the patient continued to be hypoxemic after verified intubation with pulse oximetry of 86%-88% and hypotensive with a blood pressure of 70/50. Sirens were played at 65 decibels to mimic prehospital transport conditions. A simulation educator stated aloud the time diagnoses were made and procedures performed, which were recorded by the study investigator. Paramedics completed a pre-survey and post-survey.
RESULTS


Thirty paramedics were randomized to the control group; 30 paramedics were randomized to the US intervention group. Most paramedics had not received prior US training, had not previously performed a POCUS exam, and were uncomfortable with POCUS. Point-of-care US use was significantly higher in the US intervention group for both simulation cases (P <.001). A higher percentage of paramedics in the US intervention group arrived at the correct diagnosis (77%) for the TPTX case as compared to the control group (57%), although this difference was not significantly different (P = 0.1). There was no difference in the correct diagnosis between the control and US intervention groups for the undifferentiated shock case. On the post-survey, more paramedics in the US intervention group were comfortable with POCUS for evaluation of the lung and comfortable decompressing TPTX using POCUS (P <.001). Paramedics reported POCUS was within their scope of practice.
CONCLUSIONS


Despite being novice POCUS users, the paramedics were more likely to correctly diagnose TPTX during simulation after a brief POCUS educational intervention. However, this difference was not statistically significant. Paramedics were comfortable using POCUS and felt its use improved their TPTX diagnostic skills.",2020,There was no difference in the correct diagnosis between the control and US intervention groups for the undifferentiated shock case.,['Thirty paramedics were randomized to the control group; 30 paramedics'],"['control group did not receive any POCUS training', 'right unilateral TPTX and undifferentiated shock (no TPTX', '30-minute cardiac and lung POCUS lecture followed by hands-on US training', 'ultrasound (US) use after brief point-of-care ultrasound (POCUS) training', 'Care Ultrasound Education']","['TPTX diagnostic skills', 'correct diagnosis']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0264558', 'cui_str': 'Tension pneumothorax'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0264558', 'cui_str': 'Tension pneumothorax'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",30.0,0.0330613,There was no difference in the correct diagnosis between the control and US intervention groups for the undifferentiated shock case.,"[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Khalil', 'Affiliation': 'Denver Health/University of Colorado, Department of Emergency Medicine, Denver, ColoradoUSA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Merelman', 'Affiliation': 'Rocky Vista University College of Osteopathic Medicine, MS-3, Parker, ColoradoUSA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Riccio', 'Affiliation': 'South Metro Fire Rescue Authority, Centennial, ColoradoUSA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'South Metro Fire Rescue Authority, Centennial, ColoradoUSA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shelton', 'Affiliation': 'South Metro Fire Rescue Authority, Centennial, ColoradoUSA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Meyers', 'Affiliation': 'South Metro Fire Rescue Authority, Centennial, ColoradoUSA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ketchmark', 'Affiliation': 'South Metro Fire Rescue Authority, Centennial, ColoradoUSA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Garneau', 'Affiliation': 'SonoSim, Denver, ColoradoUSA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Khalil', 'Affiliation': 'Independent Researcher.'}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Roosevelt', 'Affiliation': 'Denver Health/University of Colorado, Department of Emergency Medicine, Denver, ColoradoUSA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Toney', 'Affiliation': 'Denver Health/University of Colorado, Department of Emergency Medicine, Denver, ColoradoUSA.'}]",Prehospital and disaster medicine,['10.1017/S1049023X20001399']
2207,31937341,Bayesian adaptive designs for multi-arm trials: an orthopaedic case study.,"BACKGROUND


Bayesian adaptive designs can be more efficient than traditional methods for multi-arm randomised controlled trials. The aim of this work was to demonstrate how Bayesian adaptive designs can be constructed for multi-arm phase III clinical trials and assess potential benefits that these designs offer.
METHODS


We constructed several alternative Bayesian adaptive designs for the Collaborative Ankle Support Trial (CAST), which was a randomised controlled trial that compared four treatments for severe ankle sprain. These designs incorporated response adaptive randomisation (RAR), arm dropping, and early stopping for efficacy or futility. We studied the operating characteristics of the Bayesian designs via simulation. We then virtually re-executed the trial by implementing the Bayesian adaptive designs using patient data sampled from the CAST study to demonstrate the practical applicability of the designs.
RESULTS


We constructed five Bayesian adaptive designs, each of which had high power and recruited fewer patients on average than the original designs target sample size. The virtual executions showed that most of the Bayesian designs would have led to trials that declared superiority of one of the interventions over the control. Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis. Similar estimates and conclusions were obtained from the Bayesian adaptive designs as from the original trial.
CONCLUSIONS


Using CAST as an example, this case study shows how Bayesian adaptive designs can be constructed for phase III multi-arm trials using clinically relevant decision criteria. These designs demonstrated that they can potentially generate earlier results and allocate more patients to better performing arms. We recommend the wider use of Bayesian adaptive approaches in phase III clinical trials.
TRIAL REGISTRATION


CAST study registration ISRCTN, ISRCTN37807450. Retrospectively registered on 25 April 2003.",2020,Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis.,['severe ankle sprain'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}]",[],[],5.0,0.209351,Bayesian adaptive designs with RAR or arm dropping were more likely to allocate patients to better performing arms at each interim analysis.,"[{'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Ryan', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK. E.G.Ryan@bham.ac.uk.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Centre for Rehabilitation Research, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), Botnar Research Centre, University of Oxford, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.'}]",Trials,['10.1186/s13063-019-4021-0']
2208,31963378,Endothelial Dysfunction and Advanced Glycation End Products in Patients with Newly Diagnosed Versus Established Diabetes: From the CORDIOPREV Study.,"Endothelial dysfunction and intima-media thickness of common carotid arteries (IMT-CC) are considered subclinical markers of atherosclerotic cardiovascular disease (ASCVD). Advanced glycation end products (AGEs) are increased in type 2 diabetes mellitus (T2DM) patients, compared with non-diabetics, being implicated in micro- and macrovascular complications. Our aim was to compare serum AGEs levels and subclinical atherosclerotic markers between patients with established and newly diagnosed T2DM. Among 540 patients with T2DM and coronary heart disease from the CORDIOPREV study, 350 patients had established T2DM and 190 patients had newly diagnosed T2DM. Serum levels of AGEs (methylglyoxal (MG) and N-carboxymethyl lysine (CML)) and subclinical atherosclerotic markers (brachial flow-mediated vasodilation (FMD) and IMT-CC) were measured. AGEs levels (all  p  < 0.001) and IMT-CC ( p  = 0.025) were higher in patients with established vs. newly diagnosed T2DM, whereas FMD did not differ between the two groups. Patients with established T2DM and severe endothelial dysfunction (i.e., FMD < 2%) had higher serum MG levels, IMT-CC, HOMA-IR and fasting insulin levels than those with newly diagnosed T2DM and non-severe endothelial dysfunction (i.e., FMD ≥ 2%) (all  p  < 0.05). Serum CML levels were greater in patients with established vs. newly diagnosed T2DM, regardless of endothelial dysfunction severity. Serum AGEs levels and IMT-CC were significantly higher in patients with established vs. newly diagnosed T2DM, highlighting the progressively increased risk of ASCVD in the course of T2DM. Establishing therapeutic strategies to reduce AGEs production and delay the onset of cardiovascular complications in newly diagnosed T2DM patients or minimize ASCVD risk in established T2DM patients is needed.",2020,"AGEs levels (all  p  < 0.001) and IMT-CC ( p  = 0.025) were higher in patients with established vs. newly diagnosed T2DM, whereas FMD did not differ between the two groups.","['newly diagnosed T2DM patients or minimize ASCVD risk in established T2DM patients', 'Patients with Newly Diagnosed Versus Established Diabetes', 'patients with established and newly diagnosed T2DM', '540 patients with T2DM and coronary heart disease from the CORDIOPREV study, 350 patients had established T2DM and 190 patients had newly diagnosed T2DM']",[],"['Endothelial dysfunction and intima-media thickness', 'Serum AGEs levels and IMT-CC', 'serum MG levels, IMT-CC, HOMA-IR and fasting insulin levels', 'severe endothelial dysfunction', 'AGEs levels', 'FMD', 'serum AGEs levels and subclinical atherosclerotic markers', 'Serum levels of AGEs (methylglyoxal (MG) and N-carboxymethyl lysine (CML)) and subclinical atherosclerotic markers (brachial flow-mediated vasodilation (FMD) and IMT-CC', 'Endothelial Dysfunction and Advanced Glycation End Products', 'IMT-CC', 'Serum CML levels']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4517622', 'cui_str': '190'}]",[],"[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}, {'cui': 'C4508788', 'cui_str': 'carboxymethyllysine'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}]",540.0,0.0259991,"AGEs levels (all  p  < 0.001) and IMT-CC ( p  = 0.025) were higher in patients with established vs. newly diagnosed T2DM, whereas FMD did not differ between the two groups.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'de la Cruz-Ares', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Magdalena P', 'Initials': 'MP', 'LastName': 'Cardelo', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Gutiérrez-Mariscal', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'José D', 'Initials': 'JD', 'LastName': 'Torres-Peña', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Rios', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Katsiki', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, University of Cordoba, 14004 Córdoba, Spain.'}, {'ForeName': 'María M', 'Initials': 'MM', 'LastName': 'Malagón', 'Affiliation': 'CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'López-Miranda', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Pérez-Martínez', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Lipids and Atherosclerosis Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofia University Hospital/University of Córdoba, 14004 Córdoba, Spain.'}]",Nutrients,['10.3390/nu12010238']
2209,33204147,Retrospective Assessment of Salvage to 10 kHz Spinal Cord Stimulation (SCS) in Patients Who Failed Traditional SCS Therapy: RESCUE Study.,"Background and Objectives


A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who had not maintained pain relief with LF-SCS therapy. Here, we report a large set of data from two clinical sites to assess if 10kHz-SCS is an effective salvage modality when LF-SCS fails.
Methods


We conducted a retrospective chart review of 120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS.
Results


Data were analyzed from 105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years. The mean duration of LF-SCS therapy was 4.66±3.9 years. The average Visual Analog Scale (VAS) decreased from 8.30±1.4 (median of 8) cm to 3.32±2.0 (median of 3) cm at 12 months and 3.36±2.0 (median of 3) cm at the most recent clinic visit (p<0.001) following salvage therapy. Pain relief of 50% or more was obtained in 85 out of 105 (81%) patients. Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.
Conclusion


Eighty-one percent of patient cases reviewed, where LF-SCS had failed, achieved >50% pain relief with 10kHz-SCS, and almost all exhibited some clinical improvement. Therefore, 10kHz-SCS should be considered an appropriate option to rescue failed LF-SCS.",2020,"Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.
","['105 patients between 28 and 90 years old (median 60) with chronic pain for 13.6 years', '120 patients across two clinical sites who had LF-SCS implants and were salvaged with 10kHz-SCS', 'patients who had not maintained pain relief with LF-SCS therapy', 'Patients']","['10 kHz SCS (10kHz-SCS) therapy', 'Salvage to 10 kHz Spinal Cord Stimulation (SCS']","['Opioid usage', 'pain relief', 'Pain relief', 'mean duration of LF-SCS therapy', 'average Visual Analog Scale (VAS']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",105.0,0.063245,"Opioid usage decreased from 60.3±77.1 mg to 32.1±44.0 mg MSO4 equivalents (p = 0.001) at 12 months after salvage therapy.
","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC 27103, USA.'}, {'ForeName': 'Dawood', 'Initials': 'D', 'LastName': 'Sayed', 'Affiliation': 'Department of Anesthesiology, University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology, University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Harstroem', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC 27103, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Deering', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC 27103, USA.'}]",Journal of pain research,['10.2147/JPR.S281749']
2210,33204166,Replicating Randomized Trial Results with Observational Data Using the Parametric g-Formula: An Application to Intravenous Iron Treatment in Hemodialysis Patients.,"Background


Reproducibility of clinical and epidemiologic research is important to generalize findings and has increasingly been scrutinized. A recently published randomized trial, PIVOTAL, evaluated high vs low intravenous iron dosing strategies to manage anemia in hemodialysis patients in the UK. Our objective was to assess the reproducibility of the PIVOTAL trial findings using data from a well-established cohort study, the Dialysis Outcomes and Practice Patterns Study (DOPPS).
Methods


To overcome the absence of randomization in the DOPPS, we applied the parametric g-formula, an extension of standardization to longitudinal data. We estimated the effect of a proactive high-dose vs reactive low-dose iron supplementation strategy on all-cause mortality (primary outcome), hemoglobin, two measures of iron concentration (ferritin and TSAT), and erythropoiesis-stimulating agent dose over 12 months of follow-up in 6325 DOPPS patients.
Results


Comparing high- vs low-iron dose strategies, the 1-year mortality risk difference was 0.020 (95% CI: 0.008, 0.031) and risk ratio was 1.20 (95% CI: 1.07, 1.33), compared with null 1-year findings in the PIVOTAL trial. Differences in secondary outcomes were directionally consistent but of lesser magnitude than in the PIVOTAL trial.
Conclusion


Our findings are somewhat consistent with the recent PIVOTAL trial, with discrepancies potentially attributable to model misspecification and differences between the two study populations. In addition to the importance of our results to nephrologists and hence hemodialysis patients, our analysis illustrates the utility of the parametric g-formula for generalizing results and comparing complex and dynamic treatment strategies using observational data.",2020,"the 1-year mortality risk difference was 0.020 (95% CI: 0.008, 0.031) and risk ratio was 1.20 (95% CI: 1.07, 1.33), compared with null 1-year findings in the PIVOTAL trial.","['6325 DOPPS patients', 'Hemodialysis Patients', 'hemodialysis patients in the UK']","['proactive high-dose vs reactive low-dose iron supplementation strategy', 'Parametric g-Formula']","['hemoglobin, two measures of iron concentration (ferritin and TSAT), and erythropoiesis-stimulating agent dose', '1-year mortality risk difference', 'risk ratio']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",6325.0,0.148941,"the 1-year mortality risk difference was 0.020 (95% CI: 0.008, 0.031) and risk ratio was 1.20 (95% CI: 1.07, 1.33), compared with null 1-year findings in the PIVOTAL trial.","[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Karaboyas', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Morgenstern', 'Affiliation': 'University of Michigan, Departments of Epidemiology and Environmental Health Sciences, School of Public Health, and Department of Urology, Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Fleischer', 'Affiliation': 'University of Michigan, Department of Epidemiology, Ann Arbor, MI, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Schaubel', 'Affiliation': 'University of Michigan, Department of Biostatistics, Ann Arbor, MI, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Robinson', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, MI, USA.'}]",Clinical epidemiology,['10.2147/CLEP.S283321']
2211,33204201,Healthy Sleepers Can Worsen Their Sleep by Wanting to Do so: The Effects of Intention on Objective and Subjective Sleep Parameters.,"Purpose


Sleep is regulated by homeostatic and circadian factors. In addition, psychological factors have a strong modulatory impact on our sleep, but the exact underlying mechanisms are still largely unknown. Here, we examined the role of intentions on subjective and objective sleep parameters. Young healthy sleepers were instructed to voluntarily either worsen or improve their sleep. We predicted that participants would be capable of worsening, but not improving, their sleep compared to a regular sleep condition. In addition, we predicted that the instruction to alter sleep would lead to a higher discrepancy between subjective and objective sleep variables.
Participants and Methods


Twenty-two healthy students participated in one adaptation and three experimental nights. Polysomnography and subjective sleep parameters were measured during all four nights. Participants were instructed to sleep regularly (""neutral""), better (""good"") or worse (""bad"") than normal, in a counterbalanced order.
Results


The instruction to sleep ""bad"" increased objective sleep onset latency and the number of awakings during the night. The effects were stronger on subjective sleep variables, resulting in a higher sleep misperception in the ""bad"" condition as compared to the other two conditions. The instruction to sleep ""good"" did not improve sleep nor did it affect sleep misperception.
Conclusion


We conclude that intention is sufficient to impair (but not improve) subjective and objective sleep quality and to increase sleep misperception in healthy young sleepers. Our results have important implications for the understanding of the impact of psychological factors on our sleep.",2020,"The effects were stronger on subjective sleep variables, resulting in a higher sleep misperception in the ""bad"" condition as compared to the other two conditions.","['healthy young sleepers', 'Young healthy sleepers', 'Participants and Methods\n\n\nTwenty-two healthy students participated in one adaptation and three experimental nights']","['sleep regularly (""neutral""), better (""good"") or worse (""bad']","['Objective and Subjective Sleep Parameters', 'subjective sleep variables', ' subjective and objective sleep quality', 'Polysomnography and subjective sleep parameters']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",22.0,0.0120014,"The effects were stronger on subjective sleep variables, resulting in a higher sleep misperception in the ""bad"" condition as compared to the other two conditions.","[{'ForeName': 'Selina Ladina', 'Initials': 'SL', 'LastName': 'Combertaldi', 'Affiliation': 'Division of Cognitive Biopsychology and Methods, Department of Psychology, University of Fribourg, Fribourg, FR, Switzerland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Rasch', 'Affiliation': 'Division of Cognitive Biopsychology and Methods, Department of Psychology, University of Fribourg, Fribourg, FR, Switzerland.'}]",Nature and science of sleep,['10.2147/NSS.S270376']
2212,33204249,Multishell Diffusion MRI Reflects Improved Physical Fitness Induced by Dance Intervention.,"Using multishell diffusion MRI and both tract-based spatial statistics (TBSS) and probabilistic tracking of specific tracts of interest, we evaluated the neural underpinnings of the impact of a six-month dance intervention (DI) on physical fitness and cognitive outcomes in nondemented seniors. The final cohort had 76 nondemented seniors, randomized into DI and control (life as usual) groups. Significant effects were observed between the DI and control groups in physical fitness measures and in attention. We detected associations between improved physical fitness and changes in diffusion tensor imagining (DTI) measures in the whole white matter (WM) skeleton and in the corticospinal tract and the superior longitudinal fascicle despite the fact that no significant differences in changes to the WM microstructure were found between the two groups.",2020,Significant effects were observed between the DI and control groups in physical fitness measures and in attention.,['nondemented seniors'],"['multishell diffusion MRI and both tract-based spatial statistics (TBSS', 'six-month dance intervention (DI']","['physical fitness and cognitive outcomes', 'physical fitness and changes in diffusion tensor imagining (DTI) measures']",[],"[{'cui': 'C1136216', 'cui_str': 'Magnetic Resonance Imaging, Diffusion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0154603,Significant effects were observed between the DI and control groups in physical fitness measures and in attention.,"[{'ForeName': 'Alzbeta', 'Initials': 'A', 'LastName': 'Sejnoha Minsterova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Klobusiakova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Kropacova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lubomira', 'Initials': 'L', 'LastName': 'Novakova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Brabenec', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Balazova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Grmela', 'Affiliation': 'Department of Health Promotion, Faculty of Sports Studies, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Skotakova', 'Affiliation': 'Department of Gymnastics and Combatives, Faculty of Sports Studies, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Svobodova', 'Affiliation': 'Department of Gymnastics and Combatives, Faculty of Sports Studies, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Rektorova', 'Affiliation': 'Applied Neuroscience Research Group, Central European Institute of Technology, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}]",Neural plasticity,['10.1155/2020/8836925']
2213,33204764,Safety of Hydroxychloroquine Among Outpatient Clinical Trial Participants for COVID-19.,"Background


Use of hydroxychloroquine in hospitalized patients with coronavirus disease 2019 (COVID-19), especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from 3 outpatient randomized clinical trials.
Methods


We conducted 3 randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, postexposure prophylaxis, and early treatment for COVID-19 using an internet-based design. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.
Results


We enrolled 2795 participants. The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2544 (91%) participants reported side effect data, and 748 (29%) reported at least 1 medication side effect. Side effects were reported in 40% with once-daily, 36% with twice-weekly, 31% with once-weekly hydroxychloroquine, compared with 19% with placebo. The most common side effects were upset stomach or nausea (25% with once-daily, 19% with twice-weekly, and 18% with once-weekly hydroxychloroquine, vs 11% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for once-daily, 17% twice-weekly, and 13% once-weekly hydroxychloroquine, vs 7% for placebo). Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly hydroxychloroquine. No sudden deaths occurred.
Conclusions


Data from 3 outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials, in cohorts of healthy outpatients, can safely investigate whether hydroxychloroquine is efficacious for COVID-19.
ClinicalTrialsgov Identifier


NCT04308668 for postexposure prophylaxis and early treatment trials; NCT04328467 for pre-exposure prophylaxis trial.",2020,No deaths occurred related to hydroxychloroquine.,"['cohorts of healthy outpatients', 'hospitalized patients with coronavirus disease 2019 (COVID-19', 'Two individuals were hospitalized for atrial arrhythmias, 1 on placebo and 1 on twice-weekly', 'The median age of research participants (interquartile range) was 40 (34-49) years, and 59% (1633/2767) reported no chronic medical conditions', 'We enrolled 2795 participants']","['hydroxychloroquine', 'azithromycin', 'Hydroxychloroquine', 'placebo', 'hydroxychloroquine, vs 7% for placebo']","['sudden deaths', 'Side effects', 'upset stomach or nausea', 'deaths', 'gastrointestinal side effects', 'diarrhea, vomiting, or abdominal pain']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235309', 'cui_str': 'Upset stomach'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",2795.0,0.612891,No deaths occurred related to hydroxychloroquine.,"[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': ""Lawson Research Institute, St. Joseph's Healthcare Center, London, Ontario.""}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Chagla', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa500']
2214,33204817,Mnemonic strategy training modulates functional connectivity at rest in mild cognitive impairment: Results from a randomized controlled trial.,"Introduction


Mnemonic strategy training (MST) has been shown to improve cognitive performance and increase brain activation in those with mild cognitive impairment (MCI). However, little is known regarding the effects of MST on functional connectivity (FC) at rest. The aim of the present study was to investigate the MST focused on face-name associations effect on resting-state FC in those with MCI.
Methods


Twenty-six amnestic MCI participants were randomized in MST (N = 14) and Education Program (active control; N = 12). Interventions occurred twice a week over two consecutive weeks (ie, four sessions). Resting-state functional magnetic resonance imaging was collected at pre- and post-intervention. Regions of interest (ROIs) were selected based on areas that previously showed task-related activation changes after MST. Changes were examined through ROI-to-ROI analysis and significant results were corrected for multiple comparisons.
Results


At post-intervention, only the MST group showed increased FC, whereas the control group showed decreased or no change in FC. After MST, there was an increased FC between the left middle temporal gyrus and right orbitofrontal cortex. In addition, a time-by-group interaction indicated that the MST group showed greater increased FC between the right inferior frontal gyrus and left brain regions, such as fusiform gyrus, temporal pole, and orbitofrontal cortex relative to controls.
Discussion


MST enhanced FC in regions that are functionally relevant for the training; however, not in all ROIs investigated. Our findings suggest that MST-induced changes are reflected in task-specific conditions, as previously reported, but also in general innate connectivity. Our results both enhance knowledge about the mechanisms underlying MST effects and may provide neurophysiological evidence of training transfer.",2020,"At post-intervention, only the MST group showed increased FC, whereas the control group showed decreased or no change in FC.","['mild cognitive impairment', 'Methods\n\n\nTwenty-six amnestic MCI participants']","['Education Program (active control; N\xa0=\xa012', 'Mnemonic strategy training', 'MST', 'Introduction\n\n\nMnemonic strategy training (MST']","['FC between the right inferior frontal gyrus and left brain regions, such as fusiform gyrus, temporal pole, and orbitofrontal cortex relative to controls', 'cognitive performance and increase brain activation', 'resting-state FC', 'FC between the left middle temporal gyrus and right orbitofrontal cortex', 'FC']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589105', 'cui_str': 'Strategy training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152298', 'cui_str': 'Structure of inferior frontal gyrus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0149552', 'cui_str': 'Structure of temporal pole'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}]",,0.0367676,"At post-intervention, only the MST group showed increased FC, whereas the control group showed decreased or no change in FC.","[{'ForeName': 'Sharon Sanz', 'Initials': 'SS', 'LastName': 'Simon', 'Affiliation': 'Old Age Research Group (PROTER) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Hampstead', 'Affiliation': 'Department of Psychiatry University of Michigan Ann Arbor Michigan USA.'}, {'ForeName': 'Mariana P', 'Initials': 'MP', 'LastName': 'Nucci', 'Affiliation': 'Neuroimagem Funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44) Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo São Paulo Brazil.'}, {'ForeName': 'Luiz Kobuti', 'Initials': 'LK', 'LastName': 'Ferreira', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Fábio L S', 'Initials': 'FLS', 'LastName': 'Duran', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Luciana M', 'Initials': 'LM', 'LastName': 'Fonseca', 'Affiliation': 'Old Age Research Group (PROTER) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Maria da Graça M', 'Initials': 'MDGM', 'LastName': 'Martin', 'Affiliation': 'Neuroimagem Funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44) Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo São Paulo Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ávila', 'Affiliation': 'Old Age Research Group (PROTER) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Fábio H G', 'Initials': 'FHG', 'LastName': 'Porto', 'Affiliation': 'Old Age Research Group (PROTER) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Sônia M D', 'Initials': 'SMD', 'LastName': 'Brucki', 'Affiliation': 'Department of Neurology Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Department of Preventive Medicine Paulista School of Medicine Federal University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Lyssandra S', 'Initials': 'LS', 'LastName': 'Tascone', 'Affiliation': 'Old Age Research Group (PROTER) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Edson Amaro', 'Initials': 'EA', 'LastName': 'Jr', 'Affiliation': 'Neuroimagem Funcional (NIF) - Laboratory of Medical Investigations on Magnetic Resonance Imaging (LIM-44) Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de São Paulo São Paulo Brazil.'}, {'ForeName': 'Geraldo F', 'Initials': 'GF', 'LastName': 'Busatto', 'Affiliation': 'Laboratory of Psychiatric Neuroimaging (LIM-21) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}, {'ForeName': 'Cássio M C', 'Initials': 'CMC', 'LastName': 'Bottino', 'Affiliation': 'Old Age Research Group (PROTER) Department and Institute of Psychiatry Faculty of Medicine University of São Paulo São Paulo Brazil.'}]","Alzheimer's & dementia (New York, N. Y.)",['10.1002/trc2.12075']
2215,33204834,Improving Resident Self-Efficacy in Tracheostomy Management Using a Novel Curriculum.,"Introduction


Patients receiving pediatric tracheostomy have significant risk for mortality due to compromised airway. Timely management of airway emergencies in children with tracheostomies is an important clinical skill for pediatricians. We developed this curriculum to improve residents' self-efficacy with tracheostomy management.
Methods


We collected baseline data on 67 residents from two hospitals while creating a blended curriculum with video-based instruction on routine tracheostomy change and team management of tracheostomy emergency. Forty residents enrolled in the curriculum. During an ICU rotation, they received face-to-face instruction on routine tracheostomy change in small groups, followed by assessment of managing a tracheostomy emergency during a simulation. A video completed prior to the simulation took 9 minutes, the routine tracheostomy change didactic session took 15 minutes, and the simulation instruction was completed in 10-15 minutes. We collected feedback on the effectiveness of the curriculum from the participants.
Results


All 107 residents from the baseline and intervention groups completed the self-efficacy survey. The intervention group had significantly higher changes in scores across all self-efficacy domains than the baseline group. On the curriculum feedback survey, residents rated the curriculum very highly, between 4.4 and 4.8 on a 5-point Likert scale.
Discussion


Our blended curriculum increased learners' self-efficacy and promoted learner competence in tracheostomy management. Residents scored more than 80% across all aspects of simulation assessment and reported higher self-efficacy scores following our curricular intervention.",2020,Residents scored more than 80% across all aspects of simulation assessment and reported higher self-efficacy scores following our curricular intervention.,"['67 residents from two hospitals while creating a', 'children with tracheostomies', 'Forty residents enrolled in the curriculum', 'All 107 residents from the baseline and intervention groups completed the self-efficacy survey']","['pediatric tracheostomy', 'blended curriculum with video-based instruction on routine tracheostomy change and team management of tracheostomy emergency']","['self-efficacy scores', 'learner competence', ""learners' self-efficacy""]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184635', 'cui_str': 'Tracheostomy care'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",40.0,0.0414925,Residents scored more than 80% across all aspects of simulation assessment and reported higher self-efficacy scores following our curricular intervention.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benjamin', 'Affiliation': ""Assistant Professor, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Roy', 'Affiliation': ""Medical Director-TICU, Baylor College of Medicine and Texas Children's Hospital; Assistant Professor of Pediatrics, Department of Pediatric ICU, Texas Children's Hospital and Baylor College of Medicine.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paul', 'Affiliation': ""Assistant Professor, Department of Pulmonology, Nationwide Children's Hospital and the Ohio State University College of Medicine.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Instructor, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Charles', 'Affiliation': ""Nurse Practitioner, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Nurse Practitioner, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Narsi-Prasla', 'Affiliation': ""Nurse Practitioner, Department of Otolaryngology, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Mahan', 'Affiliation': ""Associate Director, Center for Faculty Advancement, Mentoring and Engagement (FAME), the Ohio State University College of Medicine; Professor, Department of Pediatrics, Nationwide Children's Hospital and the Ohio State University College of Medicine; Program Director, Pediatric Nephrology Fellowship Programs, Nationwide Children's Hospital and the Ohio State University College of Medicine.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thammasitboon', 'Affiliation': ""Associate Professor and Director, Center for Research, Innovation and Scholarship (CRIS) in Medical Education, Baylor College of Medicine and Texas Children's Hospital.""}]",MedEdPORTAL : the journal of teaching and learning resources,['10.15766/mep_2374-8265.11010']
2216,33204865,"IVF, acupuncture and mental health: a qualitative study of perceptions and experiences of women participating in a randomized controlled trial of acupuncture during IVF treatment.","Infertility treatments such as in-vitro fertilization (IVF) are stressful and challenging to mental health and well-being. The use of alternative therapies adjunct to IVF treatment, such as acupuncture, is common and women hope to improve their chance of pregnancy and live birth. While many women engage in acupuncture adjunct to IVF in Australia, few qualitative studies of women's motivations and experiences have been conducted in this field. A qualitative study was nested within a randomized controlled trial of acupuncture during IVF treatment in order to explore women's perceptions of acupuncture, its effects in the context of IVF treatment, and how acupuncture is perceived in relation to the outcome of IVF. Fifty women randomized into both acupuncture and sham acupuncture groups were interviewed using a semi-structured format. In-depth interviews were transcribed, coded and categorized in a theoretical thematic analysis. Two primary themes emerged: 'psychological benefit' and 'perceived influence of acupuncture on fertility/medical outcome'. Regardless of randomization, women in both groups described similar psychological effects suggesting that a placebo effect was present. They were not convinced that acupuncture could enhance their treatment outcome through biomedical pathways. Rather, they perceived that acupuncture or sham acupuncture gave them a psychological advantage through increased relaxation, reduced psychological stress, and enhanced well-being and self-efficacy. In conclusion, there are significant features associated with a placebo effect in acupuncture that might be exploited to provide psychological benefit for women undertaking IVF.",2021,"Regardless of randomization, women in both groups described similar psychological effects suggesting that a placebo effect was present.","['Fifty women randomized into both', 'perceptions and experiences of women participating']","['acupuncture', 'IVF, acupuncture and mental health', 'acupuncture and sham acupuncture', 'acupuncture or sham acupuncture']","[""psychological benefit' and 'perceived influence of acupuncture on fertility/medical outcome"", 'relaxation, reduced psychological stress, and enhanced well-being and self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",50.0,0.391091,"Regardless of randomization, women in both groups described similar psychological effects suggesting that a placebo effect was present.","[{'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'de Lacey', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sanderman', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'National Institute of Complementary Medicine, Western Sydney University, Sydney, NSW, Australia.'}]",Reproductive biomedicine & society online,['10.1016/j.rbms.2020.08.004']
2217,33205372,Clinical efficacy of 0.01% atropine in retarding the progression of myopia in children.,"PURPOSE


To investigate the clinical efficacy of 0.01% atropine in slowing the progression of myopia in children and to evaluate the influence of 0.01% atropine on secretion of basal tear and stability of tear film.
METHODS


Eighty children aged 5-14 years with myopia, 40 were randomly divided into two groups consisting of those who received spectacles in addition to 0.01% atropine (SA group) and those who received only spectacles (S group). The remaining 40 children who were wearing orthokeratology (OK) lenses for 3 months were randomly divided into two groups comprising those who received OK lenses in addition to 0.01% atropine (OKA group) and those who received only OK lenses (OK group). Comprehensive ophthalmologic examinations, including slit-lamp examination, visual acuity testing, autorefraction, intraocular pressure, axial length (AL), corneal topography, Schirmer's test, and tear film break-up time (TBuT), were performed before treatment and after every 3 months treatment.
RESULTS


During the follow-up visits, evidently better spherical equivalent (SE) control over 3, 6 and 12 months was observed in the SA and OKA groups compared with the S and OK groups. The AL over 3, 6, and 12 months was evidently inhibited in the SA and OKA groups compared with the S and OK groups. No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups. However, statistically significant differences were found in TBuT results between before treatment and after 3 months treatment in the OK group (P < 0.05, paired t test) and the OKA group (P < 0.05, paired t test).
CONCLUSIONS


0.01% atropine can effectively control myopia progression and axial elongation regardless of combined treatment with spectacles or OK lenses. And 0.01% atropine has no evident effect on Schirmer's test and TBuT results; however, researchers also found that Schirmer's test and TBuT results showed a tendency to reduce after treatment with 0.01% atropine.",2020,No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups.,"['40 children who were wearing orthokeratology (OK) lenses for 3\xa0months', 'Eighty children aged 5-14\xa0years with myopia, 40', 'myopia in children']","['atropine (SA group) and those who received only spectacles', 'OK lenses in addition to 0.01% atropine (OKA group) and those who received only OK lenses', 'atropine']","[""Schirmer's test and TBuT results"", 'TBuT results', 'secretion of basal tear and stability of tear film', ""slit-lamp examination, visual acuity testing, autorefraction, intraocular pressure, axial length (AL), corneal topography, Schirmer's test, and tear film break-up time (TBuT""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0069389', 'cui_str': 'Okadaic acid'}]","[{'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}]",80.0,0.0182668,No statistically significant differences in Schirmer's test and TBuT results were observed between the S and SA groups and between the OK and OKA groups.,"[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Ophthalmology, The Second Hospital of Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian, People's Republic of China. zhaoqidyey@126.com.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hao', 'Affiliation': ""Department of Ophthalmology, The Second Hospital of Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian, People's Republic of China.""}]",International ophthalmology,['10.1007/s10792-020-01658-0']
2218,33205552,Development of a pre- and postoperative physical activity promotion program integrated in the electronic health system of patients with bladder cancer (The POPEYE study): An intervention mapping approach.,"INTRODUCTION


Uptake of sufficient physical activity before and after radical cystectomy is important to improve physical and psychosocial outcomes in bladder cancer (BC) patients.
METHODS


In this paper, we describe the development of an evidence-based and theory-informed intervention, guided by the steps of the Intervention Mapping approach, to promote physical activity before and after radical cystectomy in patients with BC.
RESULTS


The intervention is a home-based physical activity program. The preoperative timeframe of the intervention is 4 or 12 weeks, depending on administration of neoadjuvant chemotherapy. Postoperatively, the intervention will last for 12 weeks. The intervention consists of a digital oncological platform (DOP), several consultations with healthcare professionals, personal booklet and follow-up phone calls. DOP includes information, diaries, visual representation of progress, mailbox, videos of peers and treating physician explaining the benefits of physical activity, photo material of exercises and a walking program with an activity tracker. Individual goals will be set and will be self-monitored by the patient through DOP. Patients will receive alerts and regular feedback.
CONCLUSIONS


Intervention Mapping ensures transparency of all intervention components and offers a useful approach for the development of behaviour change interventions for cancer patients and for translation of theories into practice.",2020,"CONCLUSIONS


Intervention Mapping ensures transparency of all intervention components and offers a useful approach for the development of behaviour change interventions for cancer patients and for translation of theories into practice.","['cancer patients', 'patients with bladder cancer (The POPEYE study', 'bladder cancer (BC) patients', 'patients with BC']","['digital oncological platform (DOP), several consultations with healthcare professionals, personal booklet and follow-up phone calls', 'neoadjuvant chemotherapy', 'pre- and postoperative physical activity promotion program']","['DOP includes information, diaries, visual representation of progress, mailbox, videos of peers and treating physician']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0330004', 'cui_str': 'Pleuronichthys coenosus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0199374,"CONCLUSIONS


Intervention Mapping ensures transparency of all intervention components and offers a useful approach for the development of behaviour change interventions for cancer patients and for translation of theories into practice.","[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Rammant', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Deforche', 'Affiliation': 'Department of Public Health and Primary Care, Unit Health Promotion, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van Hecke', 'Affiliation': 'Department of Public Health and Primary Care, University Centre for Nursing and Midwifery, Ghent, Belgium.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Verhaeghe', 'Affiliation': 'Department of Public Health and Primary Care, University Centre for Nursing and Midwifery, Ghent, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Van Ruymbeke', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Bultijnck', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""School of Cancer and Pharmaceutical Studies, Translational Oncology & Urology Research (TOUR), King's College London, London, UK.""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fox', 'Affiliation': ""School of Cancer and Pharmaceutical Studies, Translational Oncology & Urology Research (TOUR), King's College London, London, UK.""}, {'ForeName': 'Ronny', 'Initials': 'R', 'LastName': 'Pieters', 'Affiliation': 'Department of Urology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Decaestecker', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Fonteyne', 'Affiliation': 'Department of Human Structure and Repair, Ghent University, Ghent, Belgium.'}]",European journal of cancer care,['10.1111/ecc.13363']
2219,33205573,Feasibility of high-intensity interval training in patients with left ventricular assist devices: a pilot study.,"AIMS


Patients with left ventricular assist device (LVAD) suffer from persistent exercise limitation despite improvement of their heart failure syndrome. Exercise training (ET) programmes to improve aerobic capacity have shown modest efficacy. High-intensity interval training (HIIT), as an alternative to moderate continuous training, has not been systematically tested in this population. We examine the feasibility of a short, personalized HIIT programme in patients with LVAD and describe its effects on aerobic capacity and left ventricular remodelling.
METHODS AND RESULTS


Patients on durable LVAD support were prospectively enrolled in a 15-session, 5 week HIIT programme. Turndown echocardiogram, Kansas City Cardiomyopathy Questionnaire, and cardiopulmonary exercise test were performed before and after HIIT. Training workloads for each subject were based on pretraining peak cardiopulmonary exercise test work rate (W). Percentage of prescribed training workload completed and adverse events were recorded for each subject. Fifteen subjects were enrolled [10 men, age = 51 (29-71) years, HeartMate II = 12, HeartMate 3 = 3, and time on LVAD = 18 (3-64) months]. Twelve completed post-training testing. HIIT was well tolerated, and 90% (inter-quartile range: 78, 99%) of the prescribed workload (W) was completed with no major adverse events. Improvements were seen in aV̇O 2  at ventilatory threshold [7.1 (6.5, 9.1) to 8.5 (7.7, 9.3) mL/kg/min, P = 0.04], work rate at ventilatory threshold [44 (14, 54) to 55 (21, 66) W, P = 0.05], and left ventricular end-diastolic volume [168 (144, 216) to 159 (124, 212) mL, n = 7, P = 0.02]. HIIT had no effect on maximal oxygen consumption (V̇O 2peak  ) or Kansas City Cardiomyopathy Questionnaire score.
CONCLUSIONS


Cardiopulmonary exercise test-guided HIIT is feasible and can improve submaximal aerobic capacity in stable patients with chronic LVAD support. Further studies are needed on its effects on the myocardium and its potential role in cardiac rehabilitation programmes.",2020,"HIIT had no effect on maximal oxygen consumption (V̇O 2peak  ) or Kansas City Cardiomyopathy Questionnaire score.
","['Fifteen subjects were enrolled [10 men, age\xa0=\xa051 (29-71) years, HeartMate II\xa0=\xa012, HeartMate 3\xa0=\xa03, and time on LVAD\xa0=\xa018 (3-64) months', 'patients with left ventricular assist devices', 'Patients with left ventricular assist device (LVAD', 'Patients on durable LVAD support were prospectively enrolled in a 15-session, 5\xa0week HIIT programme', 'stable patients with chronic LVAD support', 'patients with LVAD']","['personalized HIIT programme', 'high-intensity interval training', 'Exercise training (ET) programmes', 'High-intensity interval training (HIIT']","['adverse events', 'maximal oxygen consumption (V̇O 2peak  ) or Kansas City Cardiomyopathy Questionnaire score', 'tolerated', 'submaximal aerobic capacity', 'work rate at ventilatory threshold', 'left ventricular end-diastolic volume', 'Turndown echocardiogram, Kansas City Cardiomyopathy Questionnaire, and cardiopulmonary exercise test']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]",15.0,0.0151916,"HIIT had no effect on maximal oxygen consumption (V̇O 2peak  ) or Kansas City Cardiomyopathy Questionnaire score.
","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alvarez Villela', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Chinnadurai', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Kalil', 'Initials': 'K', 'LastName': 'Salkey', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Furlani', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Mounica', 'Initials': 'M', 'LastName': 'Yanamandala', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center, Department of Medicine, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Vukelic', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Jooyoung J', 'Initials': 'JJ', 'LastName': 'Shin', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Saeed', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Ulrich P', 'Initials': 'UP', 'LastName': 'Jorde', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}, {'ForeName': 'Snehal R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.'}]",ESC heart failure,['10.1002/ehf2.13106']
2220,33205662,Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial.,"Background:  Large scale randomized comparison of drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study sought to prove the non-inferiority of the DP-DES compared with the BP-DES in such patients.  Methods:  The HOST-REDUCE-POLYTECH-ACS trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, non-inferiority trial which compared the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary endpoint was patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization) at 12 months. The key secondary endpoint was device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.  Results:  A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, POCO occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (Absolute risk difference: -1.2%, P non-inferiority <0.001). The key secondary endpoint, DOCO, occurred less frequently in the DP-DES group (DP-DES vs. BP-DES: 2.6% vs. 3.9%, HR 0.67, 95% CI 0.46-0.98, p=0.038), mostly due to a reduction in target lesion revascularization. The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively).  Conclusions:  In ACS patients receiving percutaneous coronary intervention (PCI), DP-DES was non-inferior to BP-DES with regard to POCO at 12 months after index PCI.  Clinical Trial Registration:  URL: clinicaltrials.gov Unique identifier: NCT02193971.",2020,"The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively).  ","['patients with ACS', 'A total of 3413 patients', 'Patients with Acute Coronary Syndrome', 'patients with acute coronary syndrome (ACS']","['drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology', 'BP-DES', 'DP-DES', 'percutaneous coronary intervention (PCI), DP-DES', 'URL', 'Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents', 'Percutaneous Coronary Intervention']","['DOCO', 'POCO', 'patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization', 'device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization', 'rate of spontaneous non-fatal MI and stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}]","[{'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",3413.0,0.175284,"The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively).  ","[{'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jeehoon', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Hwang', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Kyu', 'Initials': 'JK', 'LastName': 'Han', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Mo', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun-Jae', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seok Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Seoul Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Keun-Ho', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Yong', 'Initials': 'WY', 'LastName': 'Shin', 'Affiliation': 'Soon Chun Hyang University Cheonan Hospital, Cheonan, Republic of Korea.'}, {'ForeName': 'Hong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Kyungil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Dong-A University Hospital, Busan, South Korea.'}, {'ForeName': 'Kyung Woo', 'Initials': 'KW', 'LastName': 'Park', 'Affiliation': 'Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.051700']
2221,33206043,Psychometric evaluation of the Nocturia Sleep Quality Scale based on data from a prospective observational study.,"STUDY OBJECTIVES


The Nocturia Sleep Quality Scale (NSQS), a novel patient-reported outcomes measure, was developed to assess the impact of sleep disturbance from nocturia. The objective of this study was to assess the psychometric properties of the NSQS, including its structure, reliability, and validity.
METHODS


Data were collected in the context of a web-based, prospective, longitudinal, observational study. Participants with nocturia were randomized 1:1 to either a group that received sleep hygiene instructions, including instructions to limit liquids at nighttime and empty bladder prior to bedtime, or one that did not receive sleep instructions. All participants were asked to provide responses to the web-based questionnaires from day 1 to day 10. Psychometric analyses, aligned with current regulatory guidance, were conducted to evaluate the daily scores and 3-day average scores of NSQS items and potential composites. Item-level analyses were conducted first, followed by composite-level analyses.
RESULTS


The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study. NSQS test-retest reliabilities were generally satisfactory. Correlations between NSQS items and related patient-reported measures tended to support the construct validity of the NSQS, and the known-groups analyses supplied evidence of its discriminating ability. NSQS responsiveness statistics were small.
CONCLUSIONS


The NSQS is a reliable and valid measure of the impact of nocturia on patients' sleep. The present analyses lay the psychometric groundwork for the use of the NSQS in future clinical trials to support product approval and labeling claims.",2020,The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study.,"['Participants with nocturia', 'Data were collected in the context of a web-based, prospective, longitudinal, observational study']","['NSQS', 'sleep hygiene instructions, including instructions to limit liquids at nighttime and empty bladder prior to bedtime, or one that did not receive sleep instructions']","['NSQS test-retest reliabilities', 'Nocturia Sleep Quality Scale (NSQS', 'NSQS responsiveness statistics', 'Nocturia Sleep Quality Scale']","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0429805', 'cui_str': 'Bladder emptying'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",,0.037563,The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study.,"[{'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, North Carolina.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, North Carolina.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'DeMuro Romano', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, North Carolina.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, North Carolina.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, North Carolina.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Yarr', 'Affiliation': 'RTI Health Solutions, Research Triangle Park, North Carolina.'}, {'ForeName': 'Kristian V', 'Initials': 'KV', 'LastName': 'Juul', 'Affiliation': 'Ferring Pharmaceuticals A/S, Copenhagen, Denmark.'}, {'ForeName': 'Fredrik L', 'Initials': 'FL', 'LastName': 'Andersson', 'Affiliation': 'Ferring Pharmaceuticals A/S, Copenhagen, Denmark.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.9010']
2222,31688157,Medication-Related Osteonecrosis of the Jaw-Comparison of Bone Imaging Using Ultrashort Echo-Time Magnetic Resonance Imaging and Cone-Beam Computed Tomography.,"OBJECTIVE


The aim of this study was to compare bone imaging between ultrashort echo-time (UTE) magnetic resonance (MR) imaging and cone-beam computed tomography (CBCT) as the reference standard in patients with medication-related osteonecrosis of the jaw (MRONJ).
MATERIALS AND METHODS


A 1-year retrospective, blinded, and randomized qualitative analysis of UTE MR images and CBCT from 19 patients with clinically diagnosed MRONJ was performed by 2 independent radiologists. Medication-related osteonecrosis of the jaw imaging hallmarks such as osteolysis, periosteal thickening, and medullary osteosclerosis were rated visually (0 and 1 to 3 for normal and mild to severe changes) for defined anatomic regions of the jaw. In addition, segmentation of these regions was performed on coregistered MR/CBCT images for the following quantitative comparison of signal intensity (SI) on MR and gray values (GVs) on CBCT images. Interreader/modality agreement (Cohen kappa), standard testing for significant differences of (non)parametric values, and Pearson correlation of signal intensity/GV were used for statistical analysis.
RESULTS


The anterior corpus of the mandible was most often affected by MRONJ (P < 0.001). Overall, interreader agreement of qualitative MRONJ hallmark scores was almost perfect (κ = 0.81) and without significant differences between modalities (κ = 0.81 vs 0.82, CBCT vs MR, respectively). Intermodality agreement for qualitative gradings was substantial for both readers (κ = 0.77 and 0.70). Signal intensity/GV in MRONJ-affected areas differed significantly from healthy bone (P < 0.001) as well as correlation significantly between modalities (r = -0.77; P < 0.001).
CONCLUSIONS


Qualitative assessment of MRONJ with radiation-free UTE MR imaging is comparable to reference standard CBCT. Quantitative measurements of both modalities significantly distinguish diseased from normal bone with strong correlations among the quantitative values in both modalities.",2020,"Signal intensity/GV in MRONJ-affected areas differed significantly from healthy bone (P < 0.001) as well as correlation significantly between modalities (r = -0.77; P < 0.001).
","['19 patients with clinically diagnosed MRONJ was performed by 2 independent radiologists', 'patients with medication-related osteonecrosis of the jaw (MRONJ']","['Bone Imaging Using Ultrashort Echo-Time Magnetic Resonance Imaging and Cone-Beam Computed Tomography', 'ultrashort echo-time (UTE) magnetic resonance (MR) imaging and cone-beam computed tomography (CBCT']","['qualitative MRONJ hallmark scores', 'Signal intensity/GV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",19.0,0.110581,"Signal intensity/GV in MRONJ-affected areas differed significantly from healthy bone (P < 0.001) as well as correlation significantly between modalities (r = -0.77; P < 0.001).
","[{'ForeName': 'Florian A', 'Initials': 'FA', 'LastName': 'Huber', 'Affiliation': 'From the Institute of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schumann', 'Affiliation': 'Department of Cranio-Maxillo-Facial and Oral Surgery, University Hospital Zurich.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'von Spiczak', 'Affiliation': 'From the Institute of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Moritz C', 'Initials': 'MC', 'LastName': 'Wurnig', 'Affiliation': 'From the Institute of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Klarhöfer', 'Affiliation': 'Siemens Healthcare AG, Zurich, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Finkenstaedt', 'Affiliation': 'From the Institute of Diagnostic and Interventional Radiology.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bedogni', 'Affiliation': 'Unit of Maxillofacial Surgery, Department of Neuroscience-DNS, University of Padua, Padua, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Guggenberger', 'Affiliation': 'From the Institute of Diagnostic and Interventional Radiology.'}]",Investigative radiology,['10.1097/RLI.0000000000000617']
2223,31771409,Assessment of lumbar disc herniaton using fractional anisotropy in diffusion tensor imaging along with conventional T2-weighted imaging.,"OBJECTIVE


To assess the usefulness of diffusion tensor imaging and its fractional anisotropy map along with conventional T2-weighted imaging in evaluating the anisotropic water diffusion variations of annulus fibres involved in herniation disc pathology.
MATERIALS AND METHODS


Seventy-five patients with previous medical ethics committee approval and informed consent experiencing low back pain were selected for this prospective randomised blinded trial. Lumbar disc fractional anisotropy maps were obtained acquiring diffusion tensor sequences on a 3T machine. The matrix of nucleus pulposus and structures of annulus fibres were analysed using fractional anisotropy textural features to highlight any presence of lumbar disc herniation. Observer variability and reliability between two neuroradiologists were evaluated. The χ 2  test, two-tailed  t  test and linear regression analysis were used to focus differences in patients' demographic data and magnetic resonance imaging findings.
RESULTS


Annular fissures with extrusions were identified using diffusion tensor imaging in 10 out of 17 discs (study group) previously assessed as bulging discs using conventional magnetic resonance imaging. Eighteen extrusions out of 39 (study group) disc levels were identified on diffusion tensor imaging compared to eight extrusions highlighted on T2-weighted imaging ( P  < 0.01). All eight (study group) disc extrusions evaluated on T2-weighted imaging showed annular fissures on diffusion tensor imaging. Seven out of 14 (study group) protrusions highlighted on T2-weighted imaging had no annular fissures on diffusion tensor imaging; thirty-six disc levels in the control group had no evidence of annular fissures on diffusion tensor imaging ( P  > 0.01).
CONCLUSIONS


The addition of diffusion tensor imaging sequences and fractional anisotropy mapping to a conventional magnetic resonance imaging protocol could be useful in detecting annular fissures and lumbar disc herniation.",2020,"RESULTS


Annular fissures with extrusions were identified using diffusion tensor imaging in 10 out of 17 discs (study group) previously assessed as bulging discs using conventional magnetic resonance imaging.",['Seventy-five patients with previous medical ethics committee approval and informed consent experiencing low back pain'],[],['annular fissures on diffusion tensor imaging'],"[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0015004', 'cui_str': 'Medical Ethics'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",[],"[{'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}]",75.0,0.0515079,"RESULTS


Annular fissures with extrusions were identified using diffusion tensor imaging in 10 out of 17 discs (study group) previously assessed as bulging discs using conventional magnetic resonance imaging.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Perri', 'Affiliation': ""Department of Clinical Sciences and Applied Biotechnology, San Salvatore Hospital, l'Aquila, Italy.""}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': ""D'Elia"", 'Affiliation': 'Department of Radiology, Policlinico di Bari, University of Bari Postgraduate Medical School, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Castorani', 'Affiliation': 'Department of Radiology, Riuniti Hospital of Foggia, University of Foggia Postgraduate Medical School, San Giovanni Rotondo (FG), Italy.'}, {'ForeName': 'Rosario Francesco', 'Initials': 'RF', 'LastName': 'Balzano', 'Affiliation': 'Department of Radiology, Riuniti Hospital of Foggia, University of Foggia Postgraduate Medical School, San Giovanni Rotondo (FG), Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Pennelli', 'Affiliation': 'Radiology Department, IRCCS Ospedale Casa Sollievo della Sofferenza, Italy.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Al-Badayneh', 'Affiliation': 'Radiology Department, The Hashemite University Faculty of Medicine, Jordan.'}, {'ForeName': 'Annunziata', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'Department of Radiology, Ospedale Monsignor Dimiccoli, Barletta, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Guglielmi', 'Affiliation': 'Department of Radiology, University of Foggia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Popolizio', 'Affiliation': 'Radiology Department, IRCCS Ospedale Casa Sollievo della Sofferenza, Italy.'}]",The neuroradiology journal,['10.1177/1971400919891288']
2224,31781100,IgA and IgG1 Specific to Vi Polysaccharide of  Salmonella  Typhi Correlate With Protection Status in a Typhoid Fever Controlled Human Infection Model.,"Vaccination against  Salmonella  Typhi using the Vi capsular polysaccharide, a T-cell independent antigen, can protect from the development of typhoid fever. This implies that antibodies to Vi alone can protect in the absence of a T cell-mediated immune response; however, protective Vi antibodies have not been well-characterized. We hypothesized that variability in the biophysical properties of vaccine-elicited antibodies, including subclass distribution and avidity, may impact protective outcomes. To interrogate the relationship between antibody properties and protection against typhoid fever, we analyzed humoral responses from participants in a vaccine efficacy (VE) trial using a controlled human infection model (CHIM) who received either a purified Vi polysaccharide (Vi-PS) or Vi tetanus toxoid conjugate (Vi-TT) vaccine followed by oral challenge with live  S . Typhi. We determined the avidity, overall magnitude, and vaccine-induced fold-change in magnitude from before immunization to day of challenge of Vi IgA and IgG subclass antibodies. Amongst those who received the Vi-PS vaccine, Vi IgA magnitude (FDR  p  = 0.01) and fold-change (FDR  p  = 0.02) were significantly higher in protected individuals compared with those individuals who developed disease (""diagnosed""). In the Vi-TT vaccine group, the responses of protected individuals had higher fold-change in Vi IgA (FDR  p  = 0.06) and higher Vi IgG1 avidity (FDR  p  = 0.058) than the diagnosed Vi-TT vaccinees, though these findings were not significant at  p  < 0.05. Overall, protective antibody signatures differed between the Vi-PS and Vi-TT vaccines, thus, we conclude that although the Vi-PS and Vi-TT vaccines were observed to have similar efficacies, these vaccines may protect through different mechanisms. These data will inform studies on mechanisms of protection against typhoid fever, including identification of antibody effector functions, as well as informing future vaccination strategies.",2019,"Amongst those who received the Vi-PS vaccine, Vi IgA magnitude (FDR  p  = 0.01) and fold-change (FDR  p  = 0.02) were significantly higher in protected individuals compared with those individuals who developed disease (""diagnosed"").",['participants in a vaccine efficacy (VE) trial using a controlled human infection model (CHIM) who received either a'],"['Typhi', 'Vi-TT vaccine', 'purified Vi polysaccharide (Vi-PS) or Vi tetanus toxoid conjugate (Vi-TT) vaccine']",['Vi IgG1 avidity'],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]","[{'cui': 'C0020855', 'cui_str': 'Immunoglobulin IgG1'}]",,0.329152,"Amongst those who received the Vi-PS vaccine, Vi IgA magnitude (FDR  p  = 0.01) and fold-change (FDR  p  = 0.02) were significantly higher in protected individuals compared with those individuals who developed disease (""diagnosed"").","[{'ForeName': 'Lindsay C', 'Initials': 'LC', 'LastName': 'Dahora', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, The NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Spreng', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Feely', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Mathura', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Seaton', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, The NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, The NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'S Munir', 'Initials': 'SM', 'LastName': 'Alam', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'S Moses', 'Initials': 'SM', 'LastName': 'Dennison', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, The NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University, Durham, NC, United States.'}]",Frontiers in immunology,['10.3389/fimmu.2019.02582']
2225,33202093,"YH12852, a Potent and Selective Receptor Agonist of 5-hydroxytryptamine, Increased Gastrointestinal Motility in Healthy Volunteers and Patients with Functional Constipation.","Gastrointestinal (GI) motility disorders are common, decreases quality of life and imposes a substantial economic burden. YH12852 is a novel agonist of 5-hydroxytryptamine for the treatment of GI motility disorders. This phase I/IIa study assessed the tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) profiles of YH12852. In the multiple dose (MD) cohort, healthy subjects and patients with functional constipation were randomized and received orally YH12852 at 0.3, 0.5, 1, 2, or 3 mg or prucalopride 2 mg or their matching placebo, once daily for 14 days after breakfast. In the multiple low-dose cohort (MLD), healthy subjects randomly received once-daily oral doses of YH12852 at 0.05 or 0.1 mg for 14 days after breakfast. Questionnaires, gastric emptying breath test (GEBT) for PD, and plasma samples for PK were collected. In the MD cohort, a total of 56 subjects (29 healthy volunteers and 27 patients with functional constipation) were randomized, of whom 48 completed the study. In MLD cohort, a total of 16 healthy subjects were randomized, and 15 subjects completed the study. YH12852 increased the average weekly frequency of spontaneous bowel movements and loosened the stool. In addition, YH12852 increased quality of life satisfaction, and decreased severity of constipation symptom and gastrointestinal symptoms. YH12852 was safe and well-tolerated up to 3 mg and showed nearly dose proportional PK. In conclusion, YH12852 was safe and enhanced gastrointestinal motility. YH12852 can be developed as an effective treatment option for GI motility disorders including functional constipation. Further studies are warranted to confirm this possibility.",2020,"In addition, YH12852 increased quality of life satisfaction, and decreased severity of constipation symptom and gastrointestinal symptoms.","['Healthy Volunteers and Patients with Functional Constipation', 'GI motility disorders', '16 healthy subjects were randomized, and 15 subjects completed the study', 'healthy subjects and patients with functional constipation', '56 subjects (29 healthy volunteers and 27 patients with functional constipation']","['5-hydroxytryptamine', 'prucalopride 2 mg or their matching placebo']","['quality of life satisfaction', 'severity of constipation symptom and gastrointestinal symptoms', 'Gastrointestinal Motility', 'tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) profiles of YH12852', 'average weekly frequency of spontaneous bowel movements and loosened the stool', 'safe and well-tolerated', 'Questionnaires, gastric emptying breath test (GEBT) for PD, and plasma samples for PK', 'safe and enhanced gastrointestinal motility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0854121', 'cui_str': 'Gastrointestinal motility disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4745453', 'cui_str': 'prucalopride 2 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4706161', 'cui_str': 'YH12852'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}]",16.0,0.031208,"In addition, YH12852 increased quality of life satisfaction, and decreased severity of constipation symptom and gastrointestinal symptoms.","[{'ForeName': 'Hyun A', 'Initials': 'HA', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology, Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Korea.'}, {'ForeName': 'Hyounggyoon', 'Initials': 'H', 'LastName': 'Yoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Yuhan Research & Development Institute, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Seong Bok', 'Initials': 'SB', 'LastName': 'Jang', 'Affiliation': 'Yuhan Research & Development Institute, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Seoungoh', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Yuhan Research & Development Institute, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Yuhan Research & Development Institute, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]",Clinical and translational science,['10.1111/cts.12924']
2226,33202098,Effects on the ocular surface from reading on different smartphone screens: A prospective randomized controlled study.,"To investigate the influence of smartphone reading on the ocular surface and to compare the various effects of different screens and light conditions on the ocular surface. 119 volunteers were randomly divided into: Light+Organic Light-Emitting Diode (OLED), Light+electronic ink (eINK), Dark+OLED and Dark+eINK. Ocular surface examinations, including noninvasive break-up time (NIBUT), noninvasive keratograph tear meniscus height (NIKTMH), ocular redness, fluorescein break-up time (FBUT), corneal fluorescein staining (CFS), meibomian gland (MG) assessment, Schirmer I Test and blinking frequency, were performed before and after a reading task. Symptoms were evaluated using the Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome Questionnaire (CVS-Q). NIBUT and FBUT were decreased statistically significantly after participants read on an OLED screen for 2 hours compared with the baseline in light and dark environments, while no statistically significant decrease was observed on an eINK screen. NIKTMH was statistically significantly decreased after reading on an OLED screen in light and dark settings, and the eINK screen had a lesser effect on NIKTMH. An obvious increase in the ocular redness, OSDI and CVS-Q scores was observed after reading on an OLED screen, while the eINK screen had a lesser effect on these indicators. Blink rate increased gradually in OLED subgroups during the reading task, while no statistically significant difference was observed in eINK subgroups. Our research suggested that reading on an OLED screen can cause ocular surface disorder and obvious subjective discomfort, while reading on an eINK screen can minimize ocular surface disorder in both dark and light environments.",2020,"NIBUT and FBUT were decreased statistically significantly after participants read on an OLED screen for 2 hours compared with the baseline in light and dark environments, while no statistically significant decrease was observed on an eINK screen.",['119 volunteers'],"['Light+Organic Light-Emitting Diode (OLED), Light+electronic ink (eINK), Dark+OLED and Dark+eINK']","['eINK screen', 'Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome Questionnaire (CVS-Q', 'Blink rate', 'noninvasive break-up time (NIBUT), noninvasive keratograph tear meniscus height (NIKTMH), ocular redness, fluorescein break-up time (FBUT), corneal fluorescein staining (CFS), meibomian gland (MG) assessment', 'NIBUT and FBUT', 'ocular redness, OSDI and CVS-Q scores']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0021510', 'cui_str': 'Ink'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0021510', 'cui_str': 'Ink'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2609092', 'cui_str': 'Computer vision syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",119.0,0.0131273,"NIBUT and FBUT were decreased statistically significantly after participants read on an OLED screen for 2 hours compared with the baseline in light and dark environments, while no statistically significant decrease was observed on an eINK screen.","[{'ForeName': 'Kelan', 'Initials': 'K', 'LastName': 'Yuan', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Mou', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Yaying', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Jingliang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}, {'ForeName': 'Xiuming', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Eye Center, Affiliated Second Hospital, School of Medicine, Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, China.'}]",Clinical and translational science,['10.1111/cts.12933']
2227,33202147,PAP Adherence and Nasal Resistance: A Randomized Control Trial of CPAP Flex  vs CPAP.,"RATIONALE


CPAP adherence is often poor in obstructive sleep apnea (OSA) and may be influenced by nasal resistance. CPAP with reduction of expiratory pressure (CPAP Flex ) may reduce discomfort in those with high nasal resistance and improve adherence in this subgroup.
OBJECTIVES


To evaluate the association of PAP adherence to nasal resistance and examine if CPAP Flex  improves adherence over CPAP in subjects with high nasal resistance.
METHODS


A randomized double-blind control cross-over trial of 4 weeks each of CPAP Flex  versus CPAP in World Trade Center dust-exposed subjects with OSA stratified by nasal resistance measured by 4-Phase Rhinomanometry.
RESULTS


317 subjects with OSA (mean AHI4%=17±14/hr) were randomized. Overall, PAP adherence was poor, but adherence to CPAP (n=239, mean hours per night (95% CI)) = 1.97h (1.68, 2.26) was greater than to CPAP Flex  (n=249, 1.65h (1.39, 1.91); difference 0.31h (0.03, 0.6 ); p<0.05). Contrary to our hypothesis there was no correlation between nasal resistance and adherence to CPAP (r=0.098, p=NS) or CPAP Flex (r=0.056, p=NS). There was no difference in adherence between CPAP and CPAP Flex  (mean Δ hours (95% CI)) in subjects with low resistance (0.33h (-0.10, 0.76)) or high nasal resistance (0.26h (-0.14, 0.66)). No significant differences were observed in any of the secondary outcomes between PAP modes.
CONCLUSIONS


Contrary to expectations, our data do not show better adherence to CPAP Flex  than to CPAP in subjects with high or low nasal resistance, and, show clinically insignificant better adherence overall with CPAP. Clinical Trial registered with Clinicaltrials.gov (NCT01753999).",2020,"There was no difference in adherence between CPAP and CPAP Flex  (mean Δ hours (95% CI)) in subjects with low resistance (0.33h (-0.10, 0.76)) or high nasal resistance (0.26h (-0.14, 0.66)).","['in World Trade Center dust-exposed subjects with OSA stratified by nasal resistance measured by 4-Phase Rhinomanometry', 'subjects with high nasal resistance', '317 subjects with OSA (mean AHI4%=17±14/hr', 'obstructive sleep apnea (OSA']","['CPAP Flex', 'CPAP with reduction of expiratory pressure (CPAP Flex ', 'CPAP Flex  versus CPAP', 'CPAP Flex  vs CPAP']","['nasal resistance and adherence to CPAP', 'adherence to CPAP', 'PAP Adherence and Nasal Resistance', 'adherence between CPAP and CPAP Flex', 'Overall, PAP adherence', 'high nasal resistance']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0430615', 'cui_str': 'Rhinomanometry'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}]",317.0,0.14355,"There was no difference in adherence between CPAP and CPAP Flex  (mean Δ hours (95% CI)) in subjects with low resistance (0.33h (-0.10, 0.76)) or high nasal resistance (0.26h (-0.14, 0.66)).","[{'ForeName': 'Jag', 'Initials': 'J', 'LastName': 'Sunderram', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School, 12287, Department of Medicine, Piscataway, New Jersey, United States; sunderja@rwjms.rutgers.edu.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Ayappa', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, Pulmonary, Critical Care and Sleep Medicine, New York, New York, United States.'}, {'ForeName': 'Shou-En', 'Initials': 'SE', 'LastName': 'Lu', 'Affiliation': 'Rutgers School of Public Health, 51893, Piscataway, New Jersey, United States.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Rutgers School of Public Health, 51893, Piscataway, New Jersey, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Black', 'Affiliation': 'Rutgers Biomedical and Health Sciences, 43337, EOHSI, Piscataway, New Jersey, United States.'}, {'ForeName': 'Akosua', 'Initials': 'A', 'LastName': 'Twumasi', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, Division of Pulmonary, Critical Care and Sleep Medicine, New York, New York, United States.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sanders', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, Division of Pulmonary, Critical Care and Sleep Medicine, New York, New York, United States.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Harrison', 'Affiliation': 'Bellevue Hospital Center, New York, Department of Medicine, New York University School of Medicine, New York, New York, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Udasin', 'Affiliation': 'Rutgers Biomedical and Health Sciences, 43337, Environmental Occupational Health Sciences Institute, Piscataway, New Jersey, United States.'}, {'ForeName': 'Nishay', 'Initials': 'N', 'LastName': 'Chitkara', 'Affiliation': 'New York University School of Medicine, 12296, New York, New York, United States.'}, {'ForeName': 'Rafael E', 'Initials': 'RE', 'LastName': 'de la Hoz', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, Environmental Medicine and Public Health, New York, New York, United States.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Carson', 'Affiliation': 'Rutgers Robert Wood Johnson Medical School Department of Medicine, 236455, New Brunswick, New Jersey, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Rapoport', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 5925, New York, New York, United States.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202009-1161OC']
2228,32468749,Comparison Of Effectiveness Of Antipsychotics In Schizophrenia: Second-Generation Versus The Irstgeneration.,"BACKGROUND


The choice of the antipsychotic medication is based upon the risks, benefits and the cost. There has been still a debate that which group of antipsychotics is overall better amongst the two so we planned this study with the objective to compare the efficacy of the 1st & 2nd generation antipsychotics for the treatment of schizophrenia.
METHODS


This RCT was conducted at in/out patient department of Psychiatry at a tertiary care hospital of Pakistan over the time period of six months. All the patients of schizophrenia between 18-50 years of age of either gender and all the socioeconomic groups were included in the study. Each patient was assessed with the Simpson-Angus Scale (SAS) for the EPS and the Positive and Negative Syndrome Scale (PANSS) for the schizophrenia at the baseline, 6 weeks and 12 weeks after starting the designated medication.
RESULTS


The mean age of the 350 patients included in the study was 34.25±16.74 years. One hundred and forty-eight (42.3%) patients were female and 202 (57.7%) were male. The overall response of 1st Generation & 2nd Generation antipsychotics was 51 (140) 36% and 135 (210) 64% respectively (p-value=0.00024). Sixty-three (45%) patients who were taking 1st Generation Antipsychotics had relapse of the disease as compared to the 29 (13.7%) patients who were taking the 2nd Generation antipsychotics. Dryness of mouth, sedation and EPS were the common side effects with the 1st generation antipsychotics while dryness of mouth, cardiac arrhythmias, and sexual dysfunction were the common side effects with the 2nd generation antipsychotics.
CONCLUSIONS


This study concluded that the 2nd generation antipsychotics were superior to the 1st generation antipsychotics among the patients of schizophrenia in terms of the success rate, relapse rate and the tolerability.",2020,"Dryness of mouth, sedation and EPS were the common side effects with the 1st generation antipsychotics while dryness of mouth, cardiac arrhythmias, and sexual dysfunction were the common side effects with the 2nd generation antipsychotics.
","['out patient department of Psychiatry at a tertiary care hospital of Pakistan over the time period of six months', 'One hundred and forty-eight (42.3', 'The mean age of the 350 patients included in the study was 34.25±16.74 years', 'patients of schizophrenia between 18-50 years of age of either gender and all the socioeconomic groups were included in the study', 'patients were female and 202 (57.7%) were male']",['Antipsychotics'],"['dryness of mouth, cardiac arrhythmias, and sexual dysfunction', 'overall response of 1st Generation & 2nd Generation antipsychotics', 'relapse of the disease', 'Dryness of mouth, sedation and EPS', 'success rate, relapse rate and the tolerability', 'Simpson-Angus Scale (SAS) for the EPS and the Positive and Negative Syndrome Scale (PANSS']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}]",350.0,0.0470796,"Dryness of mouth, sedation and EPS were the common side effects with the 1st generation antipsychotics while dryness of mouth, cardiac arrhythmias, and sexual dysfunction were the common side effects with the 2nd generation antipsychotics.
","[{'ForeName': 'Usama Bin', 'Initials': 'UB', 'LastName': 'Zubair', 'Affiliation': 'Mater Misericoiade University hospital Dublin, Ireland.'}, {'ForeName': 'Syed Azhar', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Poonch Medical College Rawalakot, Kashmir.'}, {'ForeName': 'Rizwan', 'Initials': 'R', 'LastName': 'Taj', 'Affiliation': 'Pakistan Institute of Medical Sciences, Islamabad, Pakistan.'}, {'ForeName': 'Syeda Misbah', 'Initials': 'SM', 'LastName': 'Batool', 'Affiliation': 'Al-Nafees Medical College, Islamabad, Pakistan.'}]","Journal of Ayub Medical College, Abbottabad : JAMC",[]
2229,33202447,Bleeding with Apixaban and Dalteparin in Patients with Cancer-Associated Venous Thromboembolism: Results from the Caravaggio Study.,"BACKGROUND


Direct oral anticoagulants are recommended for the treatment of cancer-associated thrombosis (CAT) as an alternative to low-molecular-weight heparin (LMWH), but an increased bleeding risk in patients with gastrointestinal cancer was reported. The Caravaggio study compared apixaban and dalteparin for the treatment of patients with CAT. Here we describe sites of bleeding, associated cancer sites, clinical presentation, and course of major bleeding in patients included in the Caravaggio study.
METHODS


The Caravaggio study was a multinational, randomized, open-label, noninferiority study. Bleeding events and the severity of major bleedings were adjudicated by a committee unaware of treatment allocation using predefined criteria; for the purpose of this analysis, data were analyzed in the safety population.
RESULTS


Major bleeding occurred in 22 of 576 patients on apixaban (3.8%) and in 23 of 579 patients on dalteparin (4.0%). The sites of major bleeding and their distribution according to the type of cancer were similar between the two treatment groups. Major bleeding occurred in nine patients with gastrointestinal cancer in each treatment group. The clinical presentation of major bleeding was severe or fatal in 6 patients on apixaban and in 5 patients on dalteparin, while the clinical course was severe in 5 patients on apixaban and in 7 patients on dalteparin.
CONCLUSION


Apixaban is a safe alternative to LMWH for the treatment in patients with CAT. No excess in gastrointestinal bleeding was observed in patients who received apixaban, including those with gastrointestinal cancer.",2020,The sites of major bleeding and their distribution according to the type of cancer were similar between the two treatment groups.,"['576 patients on apixaban (3.8%) and in 23 of 579 patients on', 'patients with gastrointestinal cancer', 'patients included in the Caravaggio study', 'patients with CAT', 'Patients with Cancer-Associated Venous Thromboembolism']","['Apixaban', 'Apixaban and Dalteparin', 'dalteparin', 'apixaban and dalteparin', 'apixaban']","['Bleeding events and the severity of major bleedings', 'Major bleeding', 'bleeding risk', 'gastrointestinal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",,0.0161809,The sites of major bleeding and their distribution according to the type of cancer were similar between the two treatment groups.,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Clinical Medicine, University of Insubria, Varese, Italy.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Vedovati', 'Affiliation': 'Internal, Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematology, St. Thomas' Hospital, King's College, London, United Kingdom.""}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': 'Klinikum Darmstadt GmbH, Darmstadt, Germany.'}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': 'Clinical Research Department, FADOI Foundation, Milan, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': 'Internal, Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': 'Internal, Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia, Italy.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1720975']
2230,33202559,Evaluation of the Combination of Muscle Energy Technique and Trigger Point Therapy in Asymptomatic Individuals with a Latent Trigger Point.,"(1) Background: The aim of the study was to determine the effect of the combination therapy of Muscle Energy Technique (MET) and Trigger Point Therapy (TPT) on the angular values of the range of movements of the cervical spine and on the pressure pain threshold (PPT) of the trapezius muscle in asymptomatic individuals. METHODS: The study involved 60 right-handed, asymptomatic students with a latent trigger point in the upper trapezius muscle. All qualified volunteers practiced amateur symmetrical sports. The study used a tensometric electrogoniometer (cervical spine movement values) and an algometer (pressure pain threshold (PPT) of upper trapezius). Randomly (sampling frame), volunteers were assigned to three different research groups (MET + TPT, MET and TPT). All participants received only one therapeutic intervention. Measurements were taken in three time-intervals (pre, post and follow-up the next day after therapy). (2) Results: One-time combined therapy (MET + TPT) significantly increases the range of motion occurring in all planes of the cervical spine. One-time treatments of single MET and single TPT therapy selectively affect the mobility of the cervical spine. The value of the PPT significantly increased immediately after all therapies, but only on the right trapezius muscle, while on the left side only after the therapy combining MET with TPT. (3) Conclusion: The MET + TPT method proved to be the most effective, as it caused changes in all examined goniometric and subjective parameters.",2020,"The value of the PPT significantly increased immediately after all therapies, but only on the right trapezius muscle, while on the left side only after the therapy combining MET with TPT.","['asymptomatic individuals', 'Asymptomatic Individuals with a Latent Trigger Point', '60 right-handed, asymptomatic students with a latent trigger point in the upper trapezius muscle']","['Muscle Energy Technique and Trigger Point Therapy', 'One-time combined therapy (MET + TPT', 'Muscle Energy Technique (MET) and Trigger Point Therapy (TPT', 'TPT therapy', 'tensometric electrogoniometer (cervical spine movement values) and an algometer (pressure pain threshold (PPT) of upper trapezius']",['mobility of the cervical spine'],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}]","[{'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]",60.0,0.0153653,"The value of the PPT significantly increased immediately after all therapies, but only on the right trapezius muscle, while on the left side only after the therapy combining MET with TPT.","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wendt', 'Affiliation': 'Department of Biology and Anatomy, Poznan University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Waszak', 'Affiliation': 'Department of Biology and Anatomy, Poznan University of Physical Education, 61-871 Poznań, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17228430']
2231,33202607,Effect of a Mediterranean Diet-Based Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus and Other Maternal-Fetal Adverse Events in Hispanic Women Residents in Spain.,"Gestational diabetes mellitus (GDM) is the most frequent morbidity found in pregnancy, and it increases the risk for several maternal-fetal complications. Hispanic women are considered at high risk. The St. Carlos GDM prevention study is a randomized controlled trial (RCT) conducted from 2016-2017. Normoglycemic women were randomized at 12-14 Gestation week (WG) to an intervention group (IG) receiving recommendations based on the MedDiet (supplemented with ExtraVirgin Olive Oil/pistachios), or to a control group (CG), recommended to limit fat intake. After RCT conclusion, IG recommendations were applied to a real-world group (RW) in routine clinical practice. The primary endpoint of the current study is an assessment of the GDM rate in Hispanic participants of the aforementioned studies: 132 RCT, 128 CT, 284 RW participants. The GDM rate was lower in IG: 19/128(14.8%),  p  = 0.021, and RW: 38/284(13.4%),  p  = 0.029) than in CG: 34/132(25.8%). Adjusted RR (95%CI) for GDM: 0.72 (0.50-0.97),  p  = 0.037 in IG and 0.77 (0.61-0.97),  p  = 0.008 in RW. Rates of urinary tract infections, emergency caesarean-sections and perineal trauma were also lower in IG and RW. Other adverse outcomes were lower in IG vs. CG. In conclusion, a MedDiet-based intervention reduces the rate of GDM and several adverse maternal-fetal outcomes in Hispanic women residing in Spain.",2020,"The GDM rate was lower in IG: 19/128(14.8%),  p  = 0.021, and RW: 38/284(13.4%),  p  = 0.029) than in CG: 34/132(25.8%).","['Normoglycemic women', 'Gestational diabetes mellitus (GDM', 'Hispanic Women Residents in Spain', 'Hispanic participants of the aforementioned studies: 132 RCT, 128 CT, 284 RW participants', 'Hispanic women residing in Spain', 'Hispanic women']","['Mediterranean Diet-Based Nutritional Intervention', 'intervention group (IG) receiving recommendations based on the MedDiet (supplemented with ExtraVirgin Olive Oil/pistachios), or to a control group (CG']","['Rates of urinary tract infections, emergency caesarean-sections and perineal trauma', 'Risk of Developing Gestational Diabetes Mellitus', 'GDM rate', 'rate of GDM and several adverse maternal-fetal outcomes']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0459819', 'cui_str': 'Pistachio nut'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0826849,"The GDM rate was lower in IG: 19/128(14.8%),  p  = 0.021, and RW: 38/284(13.4%),  p  = 0.029) than in CG: 34/132(25.8%).","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Melero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'García de la Torre', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Assaf-Balut', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Del Valle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Durán', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bordiú', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Johanna J', 'Initials': 'JJ', 'LastName': 'Valerio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Herraiz', 'Affiliation': 'Medicina 2 Department, Facultad de Medicina, Universidad Complutense de Madrid, E 28040 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Izquierdo', 'Affiliation': 'Medicina 2 Department, Facultad de Medicina, Universidad Complutense de Madrid, E 28040 Madrid, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Torrejón', 'Affiliation': 'Clinical Laboratory Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Runkle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barabash', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rubio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso L', 'Initials': 'AL', 'LastName': 'Calle-Pascual', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}]",Nutrients,['10.3390/nu12113505']
2232,33202691,Short Nighttime Sleep Duration and High Number of Nighttime Awakenings Explain Increases in Gestational Weight Gain and Decreases in Physical Activity but Not Energy Intake among Pregnant Women with Overweight/Obesity.,"Pregnant women are at a high risk for experiencing sleep disturbances, excess energy intake, low physical activity, and excessive gestational weight gain (GWG). Scant research has examined how sleep behaviors influence energy intake, physical activity, and GWG over the course of pregnancy. This study conducted secondary analyses from the Healthy Mom Zone Study to examine between- and within-person effects of weekly sleep behaviors on energy intake, physical activity, and GWG in pregnant women with overweight/obesity (PW-OW/OB) participating in an adaptive intervention to manage GWG. The overall sample of  N  = 24 ( M  age = 30.6 years,  SD  = 3.2) had an average nighttime sleep duration of 7.2 h/night. In the total sample, there was a significant between-person effect of nighttime awakenings on physical activity; women with >1 weekly nighttime awakening expended 167.56 less physical activity kcals than women with <1 nighttime awakening. A significant within-person effect was also found for GWG such that for every increase in one weekly nighttime awakening there was a 0.76 pound increase in GWG. There was also a significant within-person effect for study group assignment; study group appeared to moderate the effect of nighttime awakenings on GWG such that for every one increase in weekly nighttime awakening, the control group gained 0.20 pounds more than the intervention group. There were no significant between- or within-person effects of sleep behaviors on energy intake. These findings illustrate an important need to consider the influence of sleep behaviors on prenatal physical activity and GWG in PW-OW/OB. Future studies may consider intervention strategies to reduce prenatal nighttime awakenings.",2020,"There was also a significant within-person effect for study group assignment; study group appeared to moderate the effect of nighttime awakenings on GWG such that for every one increase in weekly nighttime awakening, the control group gained 0.20 pounds more than the intervention group.","['Pregnant Women with Overweight/Obesity', 'Pregnant women', 'pregnant women with overweight/obesity (PW-OW/OB', 'The overall sample of  N  = 24 ( M  age = 30.6 years,  SD  = 3.2) had an average nighttime sleep duration of 7.2 h/night']",[],"['Gestational Weight Gain', 'prenatal nighttime awakenings', 'nighttime awakenings', 'sleep behaviors on energy intake', 'Physical Activity', 'nighttime awakenings on physical activity', 'physical activity kcals', 'experiencing sleep disturbances, excess energy intake, low physical activity, and excessive gestational weight gain (GWG', 'weekly nighttime awakening', 'GWG']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",[],"[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.03375,"There was also a significant within-person effect for study group assignment; study group appeared to moderate the effect of nighttime awakenings on GWG such that for every one increase in weekly nighttime awakening, the control group gained 0.20 pounds more than the intervention group.","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Pauley', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, 201 Old Main, University Park, PA 16802, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Center for Childhood Obesity Research, The Pennsylvania State University, 129 Noll Laboratory, University Park, PA 16802, USA.'}, {'ForeName': 'Krista S', 'Initials': 'KS', 'LastName': 'Leonard', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, 201 Old Main, University Park, PA 16802, USA.'}, {'ForeName': 'Penghong', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'School of Engineering of Matter, Transport, Energy, Arizona State University, Tempe, AZ 85287, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'McNitt', 'Affiliation': 'Center for Childhood Obesity Research, Department of Nutritional Sciences, The Pennsylvania State University, 201 Old Main, University Park, PA 16802, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Rivera', 'Affiliation': 'School of Engineering of Matter, Transport, Energy, Arizona State University, Tempe, AZ 85287, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Department of Nutritional Sciences, The Pennsylvania State University, 201 Old Main, University Park, PA 16802, USA.'}, {'ForeName': 'Danielle Symons', 'Initials': 'DS', 'LastName': 'Downs', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, 201 Old Main, University Park, PA 16802, USA.'}]",Clocks & sleep,['10.3390/clockssleep2040036']
2233,33203027,Fruit and Vegetable Lesson Plan Pilot Intervention for Grade 5 Students from Southwestern Ontario.,"The purpose was to create and assess the impact of food literacy curriculum alongside a centrally procured school snack program among grade five students in Southwestern Ontario, Canada. Grade five students ( N  = 287) from five intervention and three controls schools participated in an 8-week food delivery program. In addition to the food delivery program, intervention schools received a resource kit and access to 42 multidisciplinary food literacy lesson plans using the produce delivered as part of the food delivery program. Participants completed matched pre- and post-test online surveys to assess fruit and vegetable intake, knowledge, preferences, and attitudes. Descriptive analyses and changes in scores between the intervention and control schools were assessed using one-way ANOVAs, paired samples  t -tests, and McNemar's tests. In total, there were 220 participants that completed both the pre- and post-test surveys. There was a significant improvement in fruit and vegetable intake ( p  = 0.038), yet no differences in knowledge of the recommended number of food group servings, knowledge of food groups, or fruit and vegetable preferences or attitudes were observed. Integrating nutrition lesson plans within core curricula classes (e.g., math, science, and literacy) can lead to modest increases in fruit and vegetable intake.",2020,"There was a significant improvement in fruit and vegetable intake ( p  = 0.038), yet no differences in knowledge of the recommended number of food group servings, knowledge of food groups, or fruit and vegetable preferences or attitudes were observed.","['220 participants that completed both the pre- and post-test surveys', 'grade five students in Southwestern Ontario, Canada', 'Grade five students ( N  = 287) from five intervention and three controls schools participated in an 8-week food delivery program', 'Grade 5 Students from Southwestern Ontario']","['food literacy curriculum alongside a centrally procured school snack program', 'Fruit and Vegetable Lesson Plan Pilot Intervention']","['fruit and vegetable intake', 'knowledge of food groups, or fruit and vegetable preferences or attitudes']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0163109,"There was a significant improvement in fruit and vegetable intake ( p  = 0.038), yet no differences in knowledge of the recommended number of food group servings, knowledge of food groups, or fruit and vegetable preferences or attitudes were observed.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Woodruff', 'Affiliation': 'Department of Kinesiology, University of Windsor, Windsor, ON N9B 3P4, Canada.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Beckford', 'Affiliation': 'Faculty of Education, University of Windsor, Windsor, ON N9B 3P4, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Segave', 'Affiliation': 'Ontario Student Nutrition Program-Southwestern, Windsor, ON N8W 5C2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17228422']
2234,33203047,Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models.,"Three-dimensional (3D) technologies are being used for patient education. For glioma, a personalized 3D model can show the patient specific tumor and eloquent areas. We aim to compare the amount of information that is understood and can be recalled after a pre-operative consult using a 3D model (physically printed or in Augmented Reality (AR)) versus two-dimensional (2D) MR images. In this explorative study, healthy individuals were eligible to participate. Sixty-one participants were enrolled and assigned to either the 2D (MRI/fMRI), 3D (physical 3D model) or AR groups. After undergoing a mock pre-operative consultation for low-grade glioma surgery, participants completed two assessments (one week apart) testing information recall using a standardized questionnaire. The 3D group obtained the highest recall scores on both assessments (Cohen's d = 1.76 and Cohen's d = 0.94, respectively, compared to 2D), followed by AR and 2D, respectively. Thus, real-size 3D models appear to improve information recall as compared to MR images in a pre-operative consultation for glioma cases. Future clinical studies should measure the efficacy of using real-size 3D models in actual neurosurgery patients.",2020,"The 3D group obtained the highest recall scores on both assessments (Cohen's d = 1.76 and Cohen's d = 0.94, respectively, compared to 2D), followed by AR and 2D, respectively.","['Sixty-one participants were enrolled and assigned to either the 2D (MRI/fMRI), 3D (physical 3D model) or AR groups', 'healthy individuals were eligible to participate', 'Glioma Surgery', 'actual neurosurgery patients']",[],['highest recall scores'],"[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0269568,"The 3D group obtained the highest recall scores on both assessments (Cohen's d = 1.76 and Cohen's d = 0.94, respectively, compared to 2D), followed by AR and 2D, respectively.","[{'ForeName': 'Sümeyye', 'Initials': 'S', 'LastName': 'Sezer', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Vitoria', 'Initials': 'V', 'LastName': 'Piai', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ter Laan', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9113660']
2235,33203167,Full Versus Trophic Feeds in Critically Ill Adults with High and Low Nutritional Risk Scores: A Randomized Controlled Trial.,"Although energy intake might be associated with clinical outcomes in critically ill patients, it remains unclear whether full or trophic feeding is suitable for critically ill patients with high or low nutrition risk. We conducted a prospective study to determine which feeding energy intakes were associated with clinical outcomes in critically ill patients with high or low nutrition risk. This was an investigator-initiated, single center, single blind, randomized controlled trial. Critically ill patients were allocated to either high or low nutrition risk based on their Nutrition Risk in the Critically Ill score, and then randomized to receive either the full or the trophic feeding. The feeding procedure was administered for six days. No significant differences were observed in in-hospital, 14-day and 28-day mortalities, the length of ventilator dependency, or ICU and hospital stay among the four groups. There were no associations between energy and protein intakes and in-hospital, 14-day and 28-day mortalities in any of the four groups. However, protein intake was positively associated with the length of hospital stay and ventilator dependency in patients with low nutrition risk receiving trophic feeding. Full or trophic feeding in critically ill patients showed no associations with clinical outcomes, regardless of nutrition risk.",2020,"There were no associations between energy and protein intakes and in-hospital, 14-day and 28-day mortalities in any of the four groups.","['critically ill patients with high or low nutrition risk', 'Critically ill patients', 'Critically Ill Adults with High and Low Nutritional Risk Scores', 'patients with low nutrition risk receiving trophic feeding', 'critically ill patients']","['Full Versus Trophic Feeds', 'high or low nutrition risk based on their Nutrition Risk']","['hospital, 14-day and 28-day mortalities, the length of ventilator dependency, or ICU and hospital stay', 'energy and protein intakes and in-hospital, 14-day and 28-day mortalities', 'length of hospital stay and ventilator dependency']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0548431,"There were no associations between energy and protein intakes and in-hospital, 14-day and 28-day mortalities in any of the four groups.","[{'ForeName': 'Chen-Yu', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Pin-Kuei', 'Initials': 'PK', 'LastName': 'Fu', 'Affiliation': 'Department of Critical Care Medicine, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Chao', 'Affiliation': 'Department of Critical Care Medicine, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Wei-Ning', 'Initials': 'WN', 'LastName': 'Wang', 'Affiliation': 'Department of Food and Nutrition, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Chao-Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Food and Nutrition, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 40201, Taiwan.'}]",Nutrients,['10.3390/nu12113518']
2236,33203309,Community-Based Participatory Research in Action: The Patient-Centered Medical Home and Neighborhood.,"BACKGROUND


The Morehouse School of Medicine Patient Centered Medical Home and Neighborhood Project was developed to implement a community-based participatory research driven, integrated patient-centered medical home and neighborhood (PCMH) pilot intervention. The purpose of the PCMHN was to develop a care coordination program for underserved, high-risk patients with multiple morbidities served by the Morehouse Healthcare Comprehensive Family Health Clinic.
MEASURES


A community needs assessment, patient surveys and provider interviews were administered.
RESULTS


Among a panel of 367 high-risk patients and potential participants, 93 participated in the intervention and 42 patients completed the intervention. The patients self-reported increased utilization of community support, increased satisfaction with health care options, and increased self-care management ability.
CONCLUSION


The results were largely attributable to the efforts of community health workers and targeted community engagement. Lessons learned from implementation and integration of a community-based participatory approach will be used to train clinicians and small practices on how to affect change using a care coordination model for underserved, high-risk patients emphasizing CBPR.",2020,"The patients self-reported increased utilization of community support, increased satisfaction with health care options, and increased self-care management ability.
","['underserved, high-risk patients with multiple morbidities served by the Morehouse Healthcare Comprehensive Family Health Clinic', '367 high-risk patients and potential participants, 93 participated in the intervention and 42 patients completed the intervention', 'Action']",['PCMHN'],[],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0600220', 'cui_str': 'Family health status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",[],[],,0.0158788,"The patients self-reported increased utilization of community support, increased satisfaction with health care options, and increased self-care management ability.
","[{'ForeName': 'Arletha', 'Initials': 'A', 'LastName': 'Williams-Livingston', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Tabia', 'Initials': 'T', 'LastName': 'Henry Akintobi', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Morehouse School of Medicine, Atlanta, GA, USA.'}]",Journal of primary care & community health,['10.1177/2150132720968456']
2237,33203317,Initiation and maintenance of behaviour change to support memory and brain health in older adults: A randomized controlled trial.,"TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02087137.",2020,ClinicalTrials.gov identifier: NCT02087137.,['older adults'],[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],[],,0.317336,ClinicalTrials.gov identifier: NCT02087137.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Vandermorris', 'Affiliation': 'Neuropsychology and Cognitive Health Program, Baycrest, Toronto, Canada.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Au', 'Affiliation': 'Department of Psychology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gardner', 'Affiliation': 'Kunin-Lunenfeld Centre for Applied Research and Evaluation, Baycrest, Toronto, Canada.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Troyer', 'Affiliation': 'Neuropsychology and Cognitive Health Program, Baycrest, Toronto, Canada.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1841656']
2238,33203365,Collaborative care for depression and anxiety disorders: results and lessons learned from the Danish cluster-randomized Collabri trials.,"BACKGROUND


Meta-analyses suggest that collaborative care (CC) improves symptoms of depression and anxiety. In CC, a care manager collaborates with a general practitioner (GP) to provide evidence-based care. Most CC research is from the US, focusing on depression. As research results may not transfer to other settings, we developed and tested a Danish CC-model (the Collabri-model) for depression, panic disorder, generalized anxiety disorder, and social anxiety disorder in general practice.
METHODS


Four cluster-randomized superiority trials evaluated the effects of CC. The overall aim was to explore if CC significantly improved depression and anxiety symptoms compared to treatment-as-usual at 6-months' follow-up. The Collabri-model was founded on a multi-professional collaboration between a team of mental-health specialists (psychiatrists and care managers) and GPs. In collaboration with GPs, care managers provided treatment according to a structured plan, including regular reassessments and follow-up. Treatment modalities (cognitive behavioral therapy, psychoeducation, and medication) were offered based on stepped care algorithms. Face-to-face meetings between GPs and care managers took place regularly, and a psychiatrist provided supervision. The control group received treatment-as-usual. Primary outcomes were symptoms of depression (BDI-II) and anxiety (BAI) at 6-months' follow-up. The incremental cost-effectiveness ratio (ICER) was estimated based on 6-months' follow-up.
RESULTS


Despite various attempts to improve inclusion rates, the necessary number of participants was not recruited. Seven hundred thirty-one participants were included: 325 in the depression trial and 406 in the anxiety trials. The Collabri-model was implemented, demonstrating good fidelity to core model elements. In favor of CC, we found a statistically significant difference between depression scores at 6-months' follow-up in the depression trial. The difference was not significant at 15-months' follow-up. The anxiety trials were pooled for data analysis due to inadequate sample sizes. At 6- and 15-months' follow-up, there was a difference in anxiety symptoms favoring CC. These differences were not statistically significant. The ICER was 58,280 Euro per QALY.
CONCLUSIONS


At 6 months, a significant difference between groups was found in the depression trial, but not in the pooled anxiety trial. However, these results should be cautiously interpreted as there is a risk of selection bias and lacking statistical power.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02678624 and NCT02678845 . Retrospectively registered on 7 February 2016.",2020,"At 6 months, a significant difference between groups was found in the depression trial, but not in the pooled anxiety trial.","['depression and anxiety disorders', 'Seven hundred thirty-one participants were included: 325 in the depression trial and 406 in the anxiety trials']","['Treatment modalities (cognitive behavioral therapy, psychoeducation, and medication', 'Collaborative care', 'collaborative care (CC', 'CC']","['incremental cost-effectiveness ratio (ICER', 'symptoms of depression (BDI-II) and anxiety (BAI', 'anxiety symptoms', 'depression scores', 'symptoms of depression and anxiety', 'depression and anxiety symptoms']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",731.0,0.0836438,"At 6 months, a significant difference between groups was found in the depression trial, but not in the pooled anxiety trial.","[{'ForeName': 'Nadja Kehler', 'Initials': 'NK', 'LastName': 'Curth', 'Affiliation': 'Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Mental Health Services, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark. nadja.kehler.curth.01@regionh.dk.'}, {'ForeName': 'Ursula Ødum', 'Initials': 'UØ', 'LastName': 'Brinck-Claussen', 'Affiliation': 'Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Mental Health Services, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Hjorthøj', 'Affiliation': 'Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Mental Health Services, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}, {'ForeName': 'Annette Sofie', 'Initials': 'AS', 'LastName': 'Davidsen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, University of Copenhagen, Øster Farimagsgade 5, Postbox 2099, 1014, Copenhagen K, Denmark.'}, {'ForeName': 'John Hagel', 'Initials': 'JH', 'LastName': 'Mikkelsen', 'Affiliation': 'Mental Health Center Frederiksberg, Mental Health Services, Nordre Fasanvej 57-59, 2000, Frederiksberg, Denmark.'}, {'ForeName': 'Marianne Engelbrecht', 'Initials': 'ME', 'LastName': 'Lau', 'Affiliation': 'Stolpegård Psychotherapy Center, Mental Health Services, Stolpegårdsvej 20, 2820, Gentofte, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Lundsteen', 'Affiliation': 'General Practitioner, Copenhagen, Denmark.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Csillag', 'Affiliation': 'Mental Health Center North Zealand, Mental Health Services, Dyrehavevej 48, 3400, Hillerød, Denmark.'}, {'ForeName': 'Kaj Sparle', 'Initials': 'KS', 'LastName': 'Christensen', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Jakobsen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, Copenhagen K, Denmark.'}, {'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, Copenhagen K, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Mental Health Services, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}, {'ForeName': 'Lene Falgaard', 'Initials': 'LF', 'LastName': 'Eplov', 'Affiliation': 'Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Mental Health Services, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.'}]",BMC family practice,['10.1186/s12875-020-01299-3']
2239,33206129,Association of Visit-to-Visit Variability in Kidney Function and Serum Electrolyte Indexes With Risk of Adverse Clinical Outcomes Among Patients With Heart Failure With Preserved Ejection Fraction.,"Importance


Although kidney dysfunction and abnormalities in serum electrolyte levels are associated with poor clinical outcomes in patients with heart failure with preserved ejection fraction (HFpEF), the association of visit-to-visit variability in such laboratory measures with long-term outcomes is unclear.
Objective


To evaluate the associations of visit-to-visit variability in indexes of kidney function (creatinine and blood urea nitrogen [BUN] levels) and serum electrolyte (sodium, chloride, and potassium) with the risk of adverse clinical outcomes among patients with chronic, stable HFpEF.
Design, Setting, and Participants


This cohort analysis used data from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial. All participants with 3 or more serial laboratory measurements who were event free within the first 4 months of enrollment were included. Data were analyzed from March 1, 2019, to January 31, 2020.
Main Outcomes and Measures


Adjusted associations between indexes of variability in serum laboratory measurements during the first 4 months of follow-up and risk of the primary composite outcome (a composite of aborted cardiac arrest, hospitalization for heart failure, or cardiovascular death) and all-cause mortality were assessed using Cox proportional hazards regression models.
Results


Of the 3445 patients enrolled in the TOPCAT trial (mean [SD] age, 68-69 [10] years; 49.7%-51.5% female), 2479 (BUN) to 3195 (potassium) were analyzed, depending on availability of serial measurements. Participants with higher laboratory variability in kidney function parameters were older, had more comorbidities, and had more severe symptoms of HFpEF. Higher visit-to-visit variability in BUN (hazard ratio [HR] per 1-SD higher average successive variability [ASV], 1.21; 95% CI, 1.10-1.33) and creatinine (HR per 1-SD higher ASV, 1.13; 95% CI, 1.04-1.22) were independently associated with a higher risk of the primary composite outcome as well as mortality independent of other baseline confounders, changes in kidney function, changes in medication dosages, and variability in other cardiometabolic parameters (systolic blood pressure and body mass index). The higher risk associated with greater variability in kidney function was consistent across subgroups of patients stratified by the presence of chronic kidney disease (CKD) at baseline (CKD: HR per 1-SD higher ASV, 1.39; 95% CI, 1.16-1.67 and no CKD: HR per 1-SD higher ASV, 1.13; 95% CI, 1.01-1.27), among placebo and spironolactone treatment arms separately (spironolactone arm: 1.30; 95% CI, 1.03-1.65 and placebo arm: HR per 1-SD higher ASV, 1.27; 95% CI, 1.04-1.56). Among serum electrolytes, variability in sodium and potassium measures were also significantly associated with a higher risk of primary composite events (sodium: HR per 1-SD higher ASV, 1.14; 95% CI, 1.01-1.30 and potassium: HR per 1-SD higher ASV, 1.21; 95% CI, 1.02-1.44).
Conclusions and Relevance


In HFpEF, visit-to-visit variability in laboratory indexes of kidney function and serum electrolytes is common and independently associated with worse long-term clinical outcomes.",2020,"Among serum electrolytes, variability in sodium and potassium measures were also significantly associated with a higher risk of primary composite events (sodium: HR per 1-SD higher ASV, 1.14; 95% CI, 1.01-1.30 and potassium: HR per 1-SD higher ASV, 1.21; 95% CI, 1.02-1.44).
","['Patients With Heart Failure With Preserved Ejection Fraction', 'patients with chronic, stable HFpEF', '3445 patients enrolled in the TOPCAT trial (mean [SD] age, 68-69', 'All participants with 3 or more serial laboratory measurements who were event free within the first 4 months of enrollment were included', 'patients with heart failure with preserved ejection fraction (HFpEF', '10] years; 49.7%-51.5% female), 2479 (BUN) to 3195 (potassium']","['placebo', 'Aldosterone Antagonist (TOPCAT', 'spironolactone']","['serum laboratory measurements during the first 4 months of follow-up and risk of the primary composite outcome (a composite of aborted cardiac arrest, hospitalization for heart failure, or cardiovascular death) and all-cause mortality', 'serum electrolytes, variability in sodium and potassium measures', 'kidney function (creatinine and blood urea nitrogen [BUN] levels) and serum electrolyte (sodium, chloride, and potassium', 'Kidney Function and Serum Electrolyte Indexes', 'kidney function and serum electrolytes', 'severe symptoms of HFpEF', 'kidney function, changes in medication dosages, and variability in other cardiometabolic parameters (systolic blood pressure and body mass index', 'kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",3445.0,0.180123,"Among serum electrolytes, variability in sodium and potassium measures were also significantly associated with a higher risk of primary composite events (sodium: HR per 1-SD higher ASV, 1.14; 95% CI, 1.01-1.30 and potassium: HR per 1-SD higher ASV, 1.21; 95% CI, 1.02-1.44).
","[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Segar', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Martens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'S Susan', 'Initials': 'SS', 'LastName': 'Hedayati', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Grodin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas.'}]",JAMA cardiology,['10.1001/jamacardio.2020.5592']
2240,33206182,Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis: The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial.,"Importance


Diverticulitis has a tendency to recur and affect quality of life.
Objective


To assess whether sigmoid resection is superior to conservative treatment in improving quality of life of patients with recurrent, complicated, or persistent painful diverticulitis.
Design, Setting, and Participants


This open-label randomized clinical trial assessed for eligibility 128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018. Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula. Outcomes were assessed using intention-to-treat analysis. A prespecified interim analysis was undertaken when 66 patients had been randomized and their 6-month follow-up was assessable. Data were analyzed from June 2018 to May 2020.
Interventions


Laparoscopic sigmoid resection or conservative treatment.
Main Outcomes and Measures


The primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between randomization and 6 months.
Results


Of 128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13 [7.6] years). A total of 72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group). The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76 [15.89] points vs -0.2 [19.07] points; difference, 11.96; 95% CI, 3.72-20.19; P = .005). Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dindo grade III or higher). There were 2 patients (5%) in the surgery group and 12 patients (31%) in the conservative treatment group who had new episodes of diverticulitis within 6 months.
Conclusions and Relevance


In this randomized clinical trial, elective laparoscopic sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications.
Trial Registration


ClinicalTrials.gov Identifier: NCT02174926.",2020,The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76,"['128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018', '128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13', 'patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications', 'patients with recurrent, complicated, or persistent painful diverticulitis', 'Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula', '72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group', '66 patients had been randomized and their 6-month follow-up was assessable']","['sigmoid resection', 'elective laparoscopic sigmoid resection', 'Laparoscopic Elective Sigmoid Resection With Conservative Treatment', 'Laparoscopic sigmoid resection or conservative treatment', 'Diverticulitis', 'Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER']","['GIQLI score', 'Quality of Life', 'Gastrointestinal Quality of Life Index (GIQLI) score', 'major complications', 'quality of life', 'new episodes of diverticulitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0037075', 'cui_str': 'Sigmoidoscopy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0227391', 'cui_str': 'Sigmoid colon structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}]",72.0,0.157415,The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Santos', 'Affiliation': 'Gastroenterological Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Mentula', 'Affiliation': 'Gastroenterological Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Pinta', 'Affiliation': 'Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Shamel', 'Initials': 'S', 'LastName': 'Ismail', 'Affiliation': 'Gastroenterological Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Juusela', 'Affiliation': 'Department of Surgery, Vaasa Central Hospital, Vaasa, Finland.'}, {'ForeName': 'Aleksi', 'Initials': 'A', 'LastName': 'Lähdesmäki', 'Affiliation': 'Department of Surgery, Hyvinkää Hospital, Hyvinkää, Finland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Scheinin', 'Affiliation': 'Gastroenterological Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Gastroenterological Surgery, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2020.5151']
2241,33206192,Effect of Vitamin D3 Supplements on Development of Advanced Cancer: A Secondary Analysis of the VITAL Randomized Clinical Trial.,"Importance


Epidemiologic and trial data suggest that vitamin D supplementation may reduce metastatic cancer and cancer mortality, reflecting shared biological pathways.
Objective


To follow up on the possible reduction in cancer death in the Vitamin D and Omega-3 Trial (VITAL) with an evaluation of whether vitamin D reduces the incidence of advanced (metastatic or fatal) cancer and an examination possible effect modification by body mass index.
Design, Setting, and Participants


VITAL is a randomized, double-blind, placebo-controlled, 2 × 2 factorial clinical trial of vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (1 g/d). This multicenter clinical trial was conducted in the United States; participants included men aged 50 years or older and women aged 55 years or older who were free of cancer and cardiovascular disease at baseline. Randomization took place from November 2011 through March 2014, and study medication ended on December 31, 2017. Data for this secondary analysis were analyzed from November 1, 2011, to December 31, 2017.
Interventions


Vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids (1 g/d) supplements.
Main Outcomes and Measures


For the present analysis, the primary outcome was a composite incidence of metastatic and fatal invasive total cancer, because the main VITAL study showed a possible reduction in fatal cancer with vitamin D supplementation and effect modification by body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) for total cancer incidence reduction for individuals with normal BMI, but not for individuals with overweight or obesity. Secondary analyses included examination of BMI (<25, 25 to < 30, and ≥30) as effect modifiers of the observed associations.
Results


Among 25 871 randomized VITAL participants (51% female; mean [SD] age, 67.1 [7.1] years), 1617 were diagnosed with invasive cancer over a median intervention period of 5.3 years (range, 3.8-6.1 years). As previously reported, no significant differences for cancer incidence by treatment arm were observed. However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83 [95% CI, 0.69-0.99]; P = .04). When stratified by BMI, there was a significant reduction for the vitamin D arm in incident metastatic or fatal cancer among those with normal BMI (BMI<25: HR, 0.62 [95% CI, 0.45-0.86]) but not among those with overweight or obesity (BMI 25-<30: HR, 0.89 [95% CI, 0.68-1.17]; BMI≥30: HR, 1.05 [95% CI, 0.74-1.49]) (P = .03 for interaction by BMI).
Conclusions and Relevance


In this randomized clinical trial, supplementation with vitamin D reduced the incidence of advanced (metastatic or fatal) cancer in the overall cohort, with the strongest risk reduction seen in individuals with normal weight.
Trial Registration


ClinicalTrials.gov Identifier: NCT01169259.",2020,"However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83","['Among 25\u202f871 randomized VITAL participants (51% female; mean [SD] age, 67.1 [7.1] years), 1617 were diagnosed with invasive cancer over a median intervention period of 5.3 years (range, 3.8-6.1 years', 'United States; participants included men aged 50 years or older and women aged 55 years or older who were free of cancer and cardiovascular disease at baseline', 'individuals with normal weight', 'Advanced Cancer']","['vitamin D supplementation', 'vitamin D', 'vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids', 'placebo', 'Vitamin D3 Supplements', 'Vitamin D3 (cholecalciferol, 2000 IU/d) and marine omega-3 fatty acids']","['cancer incidence', 'fatal cancer with vitamin D supplementation and effect modification by body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) for total cancer incidence reduction', 'examination of BMI', 'advanced cancers (metastatic or fatal', 'metastatic cancer and cancer mortality', 'incidence of advanced (metastatic or fatal) cancer', 'composite incidence of metastatic and fatal invasive total cancer']","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]",25871.0,0.654187,"However, a significant reduction in advanced cancers (metastatic or fatal) was found for those randomized to vitamin D compared with placebo (226 of 12 927 assigned to vitamin D [1.7%] and 274 of 12 944 assigned to placebo [2.1%]; HR, 0.83","[{'ForeName': 'Paulette D', 'Initials': 'PD', 'LastName': 'Chandler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Wendy Y', 'Initials': 'WY', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Oluremi N', 'Initials': 'ON', 'LastName': 'Ajala', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Giovannucci', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Willett', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.25850']
2242,33206193,Effect of Pod e-Cigarettes vs Cigarettes on Carcinogen Exposure Among African American and Latinx Smokers: A Randomized Clinical Trial.,"Importance


Fourth-generation nicotine salt pod system (NSPS) electronic cigarettes (e-cigarettes) are the leading class of e-cigarettes. They contain high nicotine concentrations, which may facilitate switching among smokers, but could also lead to increased exposure to nicotine and biomarkers of potential harm. African American and Latinx smokers experience significant tobacco-related health disparities. The potential of NSPS e-cigarettes to reduce smoking-related harm among these groups is unknown.
Objective


To compare the harm reduction potential of NSPS e-cigarette vs combustible cigarettes.
Design, Setting, and Participants


This unblinded randomized clinical trial compared 6 weeks of e-cigarette use vs cigarettes as usual from to 2018 to 2019 among smokers in the San Diego, California, and Kansas City, Missouri, areas. Participants included African American and Latinx adult combustible cigarette smokers who smoked at least 5 cigarettes/d on at least 25 of the past 30 days for at least 6 months and were interested in switching to e-cigarettes. Data were analyzed from September 18, 2019, to September 4, 2020.
Interventions


6 weeks of e-cigarette use in a choice of pod flavors (5% nicotine) along with brief education, training, and action planning to completely switch to e-cigarettes from combustible cigarettes. The control group smoked combustible cigarettes as usual.
Main Outcomes and Measures


The primary outcome was reduction in urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentration at week 6. Secondary outcomes were change in urinary cotinine, expired carbon monoxide (CO), respiratory symptoms, lung function, blood pressure, past 7-day consumption of combustible cigarettes, and switching rates (e-cigarette group only) at weeks 2 and 6.
Results


This study included 186 participants, including 92 African American participants and 94 Latinx participants. The mean (SD) age was 43.3 (12.5) years, and 75 (40.3%) were women. Participants smoked a mean (SD) of 12.1 (7.2) cigarettes/d on 6.8 (0.6) d/wk at baseline. A total of 125 participants were randomized to the e-cigarette group and 61 were randomized to the control group. At baseline, median (interquartile range) NNAL was 124 (45-197) pg/mL in the e-cigarette group and 88 (58-197) pg/mL in the control group. At week 6, the e-cigarette group had significantly greater reductions in NNAL (relative risk [RR], 0.36 [95% CI, 0.23-0.54]; P < .001), CO (RR, 0.53 [95% CI, 0.42-0.68]; P < .001), respiratory symptoms (RR, 0.63 [95% CI, 0.47-0.85]; P = .002), and number of cigarettes smoked in the past 7 days among those still smoking (RR, 0.30 [95% CI, 0.20-0.43]; P < .001) than the control group and maintained their cotinine levels (RR, 0.80 [95% CI, 0.58-1.10]; P = .17). Lung function and diastolic and systolic blood pressure remained unchanged and did not differ between groups. For participants randomized to receive e-cigarettes, 32 participants (28.1%) were exclusively using e-cigarettes at week 6, while 66 participants (57.9%) were dual using and 16 participants (14%) resumed exclusively using cigarettes.
Conclusions and Relevance


These findings suggest that e-cigarettes may be an inclusive harm reduction strategy for African American and Latinx smokers.
Trial Registration


ClinicalTrials.gov Identifier: NCT03511001.",2020,Lung function and diastolic and systolic blood pressure remained unchanged and did not differ between groups.,"['6 weeks of e-cigarette use vs cigarettes as usual from to 2018 to 2019 among smokers in the San Diego, California, and Kansas City, Missouri, areas', 'African American and Latinx smokers experience significant tobacco-related health disparities', 'Participants included African American and Latinx adult combustible cigarette smokers who smoked at least 5 cigarettes/d on at least 25 of the past 30 days for at least 6 months and were interested in switching to e-cigarettes', 'A total of 125 participants', '186 participants, including 92 African American participants and 94 Latinx participants', 'The mean (SD) age was 43.3 (12.5) years, and 75 (40.3%) were women', 'Participants smoked a mean (SD) of 12.1 (7.2) cigarettes/d on 6.8 (0.6) d/wk at baseline', 'African American and Latinx smokers', 'African American and Latinx Smokers']","['pod flavors (5% nicotine) along with brief education, training, and action planning to completely switch to e-cigarettes from combustible cigarettes', 'Importance\n\n\nFourth-generation nicotine salt pod system (NSPS) electronic cigarettes (e-cigarettes', 'NSPS e-cigarette vs combustible cigarettes', 'Pod e-Cigarettes vs Cigarettes', 'NNAL']","['cotinine levels', 'Lung function and diastolic and systolic blood pressure', 'change in urinary cotinine, expired carbon monoxide (CO), respiratory symptoms, lung function, blood pressure, past 7-day consumption of combustible cigarettes, and switching rates', 'number of cigarettes smoked', 'respiratory symptoms', 'reduction in urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentration', 'NNAL']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4083280', 'cui_str': 'Vape'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0026222', 'cui_str': 'Missouri'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}]","[{'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",125.0,0.0808842,Lung function and diastolic and systolic blood pressure remained unchanged and did not differ between groups.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, California State University, San Marcos.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Population Health, University of Kansas School of Medicine, Kansas City.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Rice', 'Affiliation': 'Department of Psychology, California State University, San Marcos.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Schmid', 'Affiliation': 'Department of Biostatistics, School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Qu', 'Affiliation': 'Department of Biostatistics, School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Program in Clinical Pharmacology, Division of Cardiology, Department of Medicine, University of California School of Medicine, San Francisco.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, School of Public Health, Department of Medicine, Alpert Medical School, Brown University, Providence, Rhode Island.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.26324']
2243,33206382,Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.,"AIM


To assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP).
METHOD


This was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4.
RESULTS


During cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively).
INTERPRETATION


Treatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles.",2020,abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose.,"['children with cerebral palsy (CP', 'children with CP (2-17y', '210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP', 'children with cerebral palsy']","['repeat abobotulinumtoxinA injections', 'abobotulinumtoxinA', '8U/kg or 16U/kg plus HETP', 'abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP', 'abobotulinumtoxinA plus HETP']","['Physician Global Assessment', 'muscular weakness', 'Therapeutic benefits', 'efficacy and safety', 'Modified Ashworth scale scores', 'Efficacy and safety', 'upper limb spasticity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0151786', 'cui_str': 'Muscle weakness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}]",210.0,0.0985347,abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose.,"[{'ForeName': 'Mauricio R', 'Initials': 'MR', 'LastName': 'Delgado', 'Affiliation': 'Department of Neurology, University of Texas Southwestern Medical Center, Scottish Rite Hospital for Children, Dallas, TX, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tilton', 'Affiliation': ""Department of Neurology, LSUHSC and Children's Hospital New Orleans, New Orleans, LA, USA.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carranza-Del Río', 'Affiliation': 'Hospital San José Celaya, Celaya, Guanajuato, Mexico.'}, {'ForeName': 'Nigar', 'Initials': 'N', 'LastName': 'Dursun', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Bonikowski', 'Affiliation': 'Mazovian Neuropsychiatry Center, Zagórze, nr Warsaw, Poland.'}, {'ForeName': 'Resa', 'Initials': 'R', 'LastName': 'Aydin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Maciag-Tymecka', 'Affiliation': 'Rehabilitation Center KROK PO KROKU, Gdansk, Poland.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Oleszek', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, University of Colorado and Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Dabrowski', 'Affiliation': 'Department of Pediatric Physical Medicine and Rehabilitation, Beaumont Health, Oakland University School of Medicine, Grosse Pointe, MI, USA.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Grandoulier', 'Affiliation': 'Atlanstat consultant for Ipsen Pharma, Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Ipsen Pharma, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Developmental medicine and child neurology,['10.1111/dmcn.14733']
2244,33206400,Oral health related quality of life in patients with disc displacement with reduction after counseling treatment versus counseling associated with jaw exercises.,"OBJECTIVE


The aim of this study was to compare the effectiveness of two types of treatment (counseling program versus counseling program plus jaw exercises) to improve the quality of life of patients with disc displacement with reduction (DDWR).
MATERIALS AND METHODS


Patients were divided into two groups. The test group received guidelines for temporomandibular disorders (TMD) plus jaw exercises for DDWR, and the control group received only guidelines for TMD. The total number of investigated patients was 70, thus 35 per group. The oral health related quality of life was assessed by the OHIP-14 questionnaire. Both groups were evaluated at the baseline and 30 days post treatment.
RESULTS


In the counseling group, there was statistically significant decrease in pain (p=0.015) and social disability (p=0.046) subscales. In the counseling plus jaw exercise group there was statistically significant decrease in all subscales (p<0.05). At 30 days follow-up, there was a statically significant difference between the two groups in pain (p=0.004), psychological discomfort (p<0.001), psychological disability (p<0.001), and social disability (p=0.029) subscales.
CONCLUSION


The counseling program plus jaw exercise protocol showed greater improvement in oral health related quality of life than the group performing only the counseling program in patients with DDWR.",2020,"In the counseling group, there was statistically significant decrease in pain (p=0.015) and social disability (p=0.046) subscales.","['patients with disc displacement with reduction after counseling treatment versus counseling associated with jaw exercises', 'patients with disc displacement with reduction (DDWR', 'Patients were divided into two groups']","['guidelines for temporomandibular disorders (TMD) plus jaw exercises for DDWR, and the control group received only guidelines for TMD', 'treatment (counseling program versus counseling program plus jaw exercises']","['social disability', 'psychological discomfort (p<0.001), psychological disability (p<0.001), and social disability', 'Oral health related quality of life', 'quality of life', 'oral health related quality of life', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0346358,"In the counseling group, there was statistically significant decrease in pain (p=0.015) and social disability (p=0.046) subscales.","[{'ForeName': 'Rafael Alvim', 'Initials': 'RA', 'LastName': 'Magesty', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}, {'ForeName': 'Mayara Aparecida Moreira', 'Initials': 'MAM', 'LastName': 'da Silva', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}, {'ForeName': 'Carolina Antunes Santa Cecília', 'Initials': 'CASC', 'LastName': 'Simões', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}, {'ForeName': 'Saulo Gabriel Moreira', 'Initials': 'SGM', 'LastName': 'Falci', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}, {'ForeName': 'Dhelfeson Willya', 'Initials': 'DW', 'LastName': 'Douglas-de-Oliveira', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}, {'ForeName': 'Patrícia Furtado', 'Initials': 'PF', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}, {'ForeName': 'Olga Dumont', 'Initials': 'OD', 'LastName': 'Flecha', 'Affiliation': 'Universidade Federal dos Vales do Jequitinhonha e Mucuri. Rua da Glória, 187 Centro, Diamantina, Minas Gerais, Brazil, 39100-000.'}]",Journal of oral rehabilitation,['10.1111/joor.13126']
2245,33206462,"Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial.","INTRODUCTION


A vaginal ring containing 25 mg of the antiretroviral dapivirine has demonstrated efficacy in reducing women's risk of sexually acquiring HIV-1; however, imperfect ring use likely diluted efficacy estimates in clinical trials. The amount of dapivirine remaining in returned rings may reflect the extent of product use, permitting estimation of HIV protection in the context of consistent use.
METHODS


We measured the amount of dapivirine in returned rings from a placebo-controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women. Phase I/II studies established that greater than 4 mg of dapivirine on average is released from the ring when used consistently over 28 days and ≤0.9 mg released suggested non-use. We assessed the relative risk reduction associated with levels of ring use using residual dapivirine in returned rings as a time-dependent covariate for HIV-1 infection in multivariable Cox models, including multiple exploratory analyses designed to estimate upper limits of efficacy given uncertainty in timing of HIV-1 acquisition. All models were adjusted for baseline covariates associated with HIV risk and adherence.
RESULTS


Residual dapivirine levels indicating at least some use (>0.9 mg released over a month) were associated with a 48% relative reduction in HIV-1 acquisition risk (95% confidence interval (CI): 21% to 66%; p = 0.002) compared to the placebo. Exploratory analyses accounting for potential misclassification in timing of HIV-1 acquisition estimated 75% to 91% HIV-1 risk reduction with> 4 mg released when compared to placebo. Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.
CONCLUSIONS


Residual dapivirine levels, an objective measure of adherence, were correlated with HIV-1 protection in a secondary analysis of a randomized trial. Periods of ring use were associated with approximately 50% protection, with exploratory analyses suggesting higher protection with more consistent use. The dapivirine vaginal ring is the first method to fulfil the promise of a fully reversible, long-acting, woman-initiated approach for discreet HIV-1 prevention.",2020,"Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.
",['controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women'],"['placebo', 'antiretroviral dapivirine', 'dapivirine']","['HIV risk and adherence', 'risk of HIV-1 acquisition', 'HIV-1 acquisition risk']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C1434916', 'cui_str': 'dapivirine'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",2629.0,0.25361,"Results limited to the subgroup of women <25 years of age, who tended to have lower adherence, were generally consistent to those overall.
","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA, USA.""}, {'ForeName': 'Flavia M', 'Initials': 'FM', 'LastName': 'Kiweewa', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Nyaradzo M', 'Initials': 'NM', 'LastName': 'Mgodi', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Philips', 'Affiliation': 'Wits Reproductive Health and HIV Research Institute, School of Clinical Medicine, University of the Witswatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Foundation Clinical Research Site, Cape Town, South Africa.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine and Magee-Womens Research Institute, Pittsburgh, PA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Departments of Medicine, Epidemiology, and Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25634']
2246,31900169,"Reliability, validity and discriminant ability of a robotic device for finger training in patients with subacute stroke.","BACKGROUND


The majority of stroke survivors experiences significant hand impairments, as weakness and spasticity, with a severe impact on the activity of daily living. To objectively evaluate hand deficits, quantitative measures are needed. The aim of this study is to assess the reliability, the validity and the discriminant ability of the instrumental measures provided by a robotic device for hand rehabilitation, in a sample of patients with subacute stroke.
MATERIAL AND METHODS


In this study, 120 patients with stroke and 40 controls were enrolled. Clinical evaluation included finger flexion and extension strength (using the Medical Research Council, MRC), finger spasticity (using the Modified Ashworth Scale, MAS) and motor control and dexterity during ADL performance (by means of the Frenchay Arm Test, FAT). Robotic evaluations included finger flexion and extension strength, muscle tone at rest, and instrumented MAS and Modified Tardieu Scale. Subjects were evaluated twice, one day apart, to assess the test-retest reliability of the robotic measures, using the Intraclass Correlation Coefficient (ICC). To estimate the response stability, the standard errors of measurement and the minimum detectable change (MDC) were also calculated. Validity was assessed by analyzing the correlations between the robotic metrics and the clinical scales, using the Spearman's Correlation Coefficient (r). Finally, we investigated the ability of the robotic measures to distinguish between patients with stroke and healthy subjects, by means of Mann-Whitney U tests.
RESULTS


All the investigated measures were able to discriminate patients with stroke from healthy subjects (p < 0.001). Test-retest reliability was found to be excellent for finger strength (in both flexion and extension) and muscle tone, with ICCs higher than 0.9. MDCs were equal to 10.6 N for finger flexion, 3.4 N for finger extension, and 14.3 N for muscle tone. Conversely, test-retest reliability of the spasticity measures was poor. Finally, finger strength (in both flexion and extension) was correlated with the clinical scales (r of about 0.7 with MRC, and about 0.5 with FAT).
DISCUSSION


Finger strength (in both flexion and extension) and muscle tone, as provided by a robotic device for hand rehabilitation, are reliable and sensitive measures. Moreover, finger strength is strongly correlated with clinical scales. Changes higher than the obtained MDC in these robotic measures could be considered as clinically relevant and used to assess the effect of a rehabilitation treatment in patients with subacute stroke.",2020,"Test-retest reliability was found to be excellent for finger strength (in both flexion and extension) and muscle tone, with ICCs higher than 0.9.","['patients with subacute stroke', '120 patients with stroke and 40 controls were enrolled', 'patients with stroke and healthy subjects, by means of Mann-Whitney U tests']",['robotic device for finger training'],"['finger flexion and extension strength, muscle tone at rest, and instrumented MAS and Modified Tardieu Scale', 'finger flexion and extension strength (using the Medical Research Council, MRC), finger spasticity (using the Modified Ashworth Scale, MAS) and motor control and dexterity during ADL performance', 'finger strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0858959', 'cui_str': 'Finger spasticity'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",120.0,0.0235698,"Test-retest reliability was found to be excellent for finger strength (in both flexion and extension) and muscle tone, with ICCs higher than 0.9.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Germanotta', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci, 269, 50143, Florence, Italy. mgermanotta@dongnocchi.it.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Gower', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Dionysia', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Cruciani', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Pecchioli', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mosca', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Speranza', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Catuscia', 'Initials': 'C', 'LastName': 'Falsini', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci, 269, 50143, Florence, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci, 269, 50143, Florence, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Vannetti', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Via di Scandicci, 269, 50143, Florence, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Montesano', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Galeri', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Gramatica', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aprile', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Piazzale Morandi 6, 20121, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0634-5']
2247,33201771,Efficacy and Tolerability of Eravacycline in Bacteremic Patients with Complicated Intra-Abdominal Infection: A Pooled Analysis from the IGNITE1 and IGNITE4 Studies.,"Background:  Eravacycline is a novel, fully synthetic fluorocycline antibiotic that was evaluated for the treatment of complicated intra-abdominal infections (cIAI) in two phase 3 clinical trials. The objective of this analysis was to evaluate the clinical cure and microbiologic response at the test-of-cure (TOC) visit and the safety of eravacycline in patients with cIAI and baseline bacteremia who received eravacycline versus comparators.  Patients and Methods:  Pooled data of patients with bacteremia from the Investigating Gram-Negative Infections Treated with Eravacycline (IGNITE) 1 and IGNITE4 studies were analyzed. All patients were randomly assigned in a one-to-one ratio to receive eravacycline 1 mg/kg intravenously every 12 hours, ertapenem 1 g intravensouly every 24 hours (IGNITE1), or meropenem 1 g intravenously every eight hours (IGNITE4) for four to 14 days. Blood and intra-abdominal samples were collected from all patients at baseline. Clinical outcome and microbiologic eradiation at the TOC visit (28 days after randomization) and safety in the microbiologic-intent-to-treat population (micro-ITT) were assessed.  Results:  Of 415 patients treated with eravacycline and 431 treated with carbapenem comparators, concurrent bacteremia was identified in 32 (7.7%) and 31 (7.2%) patients, respectively. Demographic and baseline characteristics were similar among treatment groups. In the micro-ITT population, the pooled clinical response at the TOC visit for eravacycline was 28 of 32 (87.5%) and was 24 of 31 (77.0%) for comparators among the subgroup with baseline bacteremia (treatment difference 5.9; 95% confidence interval [CI], -6.5 to 17.4). At TOC, microbiologic eradication of pathogens isolated from blood specimens occurred for 34 of 35 (97.1%) pathogens with eravacycline and 35 of 36 (97.2%) pathogens with comparators. The incidence of adverse events was comparable between treated groups and similar to that observed in the non-bacteremic population.  Conclusion:  Eravacycline demonstrated a similar clinical outcome and microbiologic eradication rate as comparator carbapenems in patients with cIAI and associated secondary bacteremia. Future clinical trials of cIAI should report outcomes of this important clinical cohort (cIAI with concurrent bacteremia) given their high risk for adverse outcomes.",2020,Eravacycline demonstrated a similar clinical outcome and microbiologic eradication rate as comparator carbapenems in patients with cIAI and associated secondary bacteremia.,"['415 patients treated with', 'patients with cIAI and baseline bacteremia who received eravacycline versus comparators', 'Bacteremic Patients with Complicated Intra-Abdominal Infection', 'patients with cIAI and associated secondary bacteremia']","['eravacycline 1\u2009mg/kg intravenously every 12 hours, ertapenem 1', 'eravacycline', 'meropenem 1', 'carbapenem', 'Eravacycline', 'Eravacycline (IGNITE']","['microbiologic eradication rate', 'Efficacy and Tolerability', 'microbiologic eradication of pathogens isolated from blood specimens', 'incidence of adverse events', 'clinical cure and microbiologic response', 'concurrent bacteremia', 'Blood and intra-abdominal samples']","[{'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C4045520', 'cui_str': 'eravacycline'}, {'cui': 'C4524048', 'cui_str': 'Complicated intra-abdominal infection'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C4045520', 'cui_str': 'eravacycline'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585327', 'cui_str': 'Every twelve hours'}, {'cui': 'C1120106', 'cui_str': 'ertapenem'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0006968', 'cui_str': 'Carbapenem'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}]",,0.138066,Eravacycline demonstrated a similar clinical outcome and microbiologic eradication rate as comparator carbapenems in patients with cIAI and associated secondary bacteremia.,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Grant-Di Felice', 'Affiliation': 'Tetraphase Pharmaceuticals, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Efimova', 'Affiliation': 'Tetraphase Pharmaceuticals, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Izmailyan', 'Affiliation': 'Tetraphase Pharmaceuticals, Inc., Watertown, Massachusetts, USA.'}, {'ForeName': 'Lena M', 'Initials': 'LM', 'LastName': 'Napolitano', 'Affiliation': 'University of Michigan Hospital, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Teena', 'Initials': 'T', 'LastName': 'Chopra', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Michigan, USA.'}]",Surgical infections,['10.1089/sur.2020.241']
2248,33201779,New Zealand blackcurrant extract enhances muscle oxygenation during repeated intermittent forearm muscle contractions in advanced and elite rock climbers.,"Anthocyanin-rich New Zealand blackcurrant (NZBC) may improve forearm muscle oxygenation and enhance performance in high-level rock climbers. As such, using a double-blind, randomised, cross-over design study, twelve participants performed an oxidative capacity assessment, and two successive exhaustive exercise trials (submaximal forearm muscle contractions at 60% of their maximal volitional contraction). Each visit was conducted following 7-days intake of 600 mg·day -1  NZBC extract or placebo. Oxidative capacity was estimated by calculating the oxygen half time recovery using near infrared spectroscopy. Time to exhaustion (s), impulse (kg·s), and minimum tissue saturation index (min-TSI %) were assessed during both the exercise trials. Muscle oxidative capacity was greater with NZBC (mean difference [MD] = 5.3 s, 95% confidence intervals [95% CI] = 0.4-10.2 s;  p  = 0.036; Cohen's  d  = 0.94). During the exercise trials, there was an interaction for min-TSI % (time x condition,  p  = 0.046;  η   p   2       = 0.372), which indicated a greater level of oxygen extraction during trial two with NZBC extract (MD = 9%, 95% CI = 2-15%) compared to the placebo (MD = 2%, 95% CI = 1-7%). There was a decrease in time to exhaustion ( p  <0.001,  η   p   2     = 0.693) and impulse ( p  = 0.001,  η   p   2     = 0.672) in exercise trial two, with no effect of NZBC extract. In high-level rock climbers 7-days NZBC extract improves forearm muscle oxygenation with no effect on isolated forearm muscle performance.  Highlights  Forearm muscle oxygenation has been shown to be an important determinant of rock-climbing performance. Finding ways in which athletes can improve forearm muscle oxygenation may enhance rock climbing performance. Previously, supplementation of New Zealand blackcurrant extract, which is rich in anthocyanins, has been shown to increase vasodilator function. However, it is not known whether New Zealand black currant extract supplementation can increase forearm muscle oxygenation and consequently performance in elite level climbers. Our study is the first to show that New Zealand blackcurrant extract significantly improves forearm muscle oxygenation in elite and advanced rock climbers with no change in forearm performance.",2020,"There was a decrease in time to exhaustion ( p  <0.001,  η   p   2     = 0.693) and impulse ( p  = 0.001,  η   p   2     = 0.672) in exercise trial two, with no effect of NZBC extract.",['advanced and elite rock climbers'],"['placebo', 'Anthocyanin-rich New Zealand blackcurrant (NZBC', 'NZBC extract', 'NZBC extract or placebo']","['isolated forearm muscle performance', 'Time to exhaustion (s), impulse (kg·s), and minimum tissue saturation index', 'Oxidative capacity', 'level of oxygen extraction', 'time to exhaustion', 'Muscle oxidative capacity', 'forearm muscle oxygenation']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005899', 'cui_str': 'Repetitive rocking movements'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",12.0,0.521467,"There was a decrease in time to exhaustion ( p  <0.001,  η   p   2     = 0.693) and impulse ( p  = 0.001,  η   p   2     = 0.672) in exercise trial two, with no effect of NZBC extract.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Giles', 'Affiliation': 'Lattice Training Ltd., Chesterfield, UK.'}, {'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Bird', 'Affiliation': 'Institute of Sport, University of Chichester, West Sussex, UK.'}, {'ForeName': 'Keeron', 'Initials': 'K', 'LastName': 'Stone', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Paterson', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucestershire, UK.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Baláš', 'Affiliation': 'Faculty of Physical Education and Sport, Prague, Czech Republic.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, West Sussex, UK.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Potter', 'Affiliation': 'Institute of Sport, University of Chichester, West Sussex, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Perkins', 'Affiliation': 'Institute of Sport, University of Chichester, West Sussex, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1827048']
2249,33201927,"Evaluation of an unconditional cash transfer program targeting children's first-1,000-days linear growth in rural Togo: A cluster-randomized controlled trial.","BACKGROUND


In 2014, the government of Togo implemented a pilot unconditional cash transfer (UCT) program in rural villages that aimed at improving children's nutrition, health, and protection. It combined monthly UCTs (approximately US$8.40 /month) with a package of community activities (including behavior change communication [BCC] sessions, home visits, and integrated community case management of childhood illnesses and acute malnutrition [ICCM-Nut]) delivered to mother-child pairs during the first ""1,000 days"" of life. We primarily investigated program impact at population level on children's height-for-age z-scores (HAZs) and secondarily on stunting (HAZ < -2) and intermediary outcomes including household's food insecurity, mother-child pairs' diet and health, delivery in a health facility and low birth weight (LBW), women's knowledge, and physical intimate partner violence (IPV).
METHODS AND FINDINGS


We implemented a parallel-cluster-randomized controlled trial, in which 162 villages were randomized into either an intervention arm (UCTs + package of community activities, n = 82) or a control arm (package of community activities only, n = 80). Two different representative samples of children aged 6-29 months and their mothers were surveyed in each arm, one before the intervention in 2014 (control: n = 1,301, intervention: n = 1,357), the other 2 years afterwards in 2016 (control: n = 996, intervention: n = 1,035). Difference-in-differences (DD) estimates of impact were calculated, adjusting for clustering. Children's average age was 17.4 (± 0.24 SE) months in the control arm and 17.6 (± 0.19 SE) months in the intervention arm at baseline. UCTs had a protective effect on HAZ (DD = +0.25 z-scores, 95% confidence interval [CI]: 0.01-0.50, p = 0.039), which deteriorated in the control arm while remaining stable in the intervention arm, but had no impact on stunting (DD = -6.2 percentage points [pp], relative odds ratio [ROR]: 0.74, 95% CI: 0.51-1.06, p = 0.097). UCTs positively impacted both mothers' and children's (18-23 months) consumption of animal source foods (ASFs) (respectively, DD = +4.5 pp, ROR: 2.24, 95% CI: 1.09-4.61, p = 0.029 and DD = +9.1 pp, ROR: 2.65, 95% CI: 1.01-6.98, p = 0.048) and household food insecurity (DD = -10.7 pp, ROR: 0.63, 95% CI: 0.43-0.91, p = 0.016). UCTs did not impact on reported child morbidity 2 week's prior to report (DD = -3.5 pp, ROR: 0.80, 95% CI: 0.56-1.14, p = 0.214) but reduced the financial barrier to seeking healthcare for sick children (DD = -26.4 pp, ROR: 0.23, 95% CI: 0.08-0.66, p = 0.006). Women who received cash had higher odds of delivering in a health facility (DD = +10.6 pp, ROR: 1.53, 95% CI: 1.10-2.13, p = 0.012) and lower odds of giving birth to babies with birth weights (BWs) <2,500 g (DD = -11.8, ROR: 0.29, 95% CI: 0.10-0.82, p = 0.020). Positive effects were also found on women's knowledge (DD = +14.8, ROR: 1.86, 95% CI: 1.32-2.62, p < 0.001) and physical IPV (DD = -7.9 pp, ROR: 0.60, 95% CI: 0.36-0.99, p = 0.048). Study limitations included the short evaluation period (24 months) and the low coverage of UCTs, which might have reduced the program's impact.
CONCLUSIONS


UCTs targeting the first ""1,000 days"" had a protective effect on child's linear growth in rural areas of Togo. Their simultaneous positive effects on various immediate, underlying, and basic causes of malnutrition certainly contributed to this ultimate impact. The positive impacts observed on pregnancy- and birth-related outcomes call for further attention to the conception period in nutrition-sensitive programs.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN83330970.",2020,"UCTs had a protective effect on HAZ (DD = +0.25 z-scores, 95% confidence interval [CI]: 0.01-0.50, p = 0.039), which deteriorated in the control arm while remaining stable in the intervention arm, but had no impact on stunting (DD = -6.2 percentage points [pp], relative odds ratio [ROR]: 0.74, 95% CI: 0.51-1.06, p = 0.097).","[""children's height-for-age z-scores (HAZs) and secondarily on stunting (HAZ < -2) and intermediary outcomes including household's food insecurity, mother-child pairs' diet and health, delivery in a health facility and low birth weight (LBW), women's knowledge, and physical intimate partner violence (IPV"", '162 villages', 'rural Togo', 'Women who received cash had higher odds of delivering in a health facility (DD = +10.6 pp, ROR', 'children aged 6-29 months and their mothers were surveyed in each arm, one before the intervention in 2014 (control: n = 1,301, intervention: n = 1,357), the other 2 years afterwards in 2016 (control: n = 996, intervention: n = 1,035']","['unconditional cash transfer (UCT) program', 'intervention arm (UCTs + package of community activities, n = 82) or a control arm (package of community activities only, n = 80', 'unconditional cash transfer program']","['child morbidity', 'lower odds of giving birth to babies with birth weights', 'protective effect on HAZ', 'physical IPV', 'financial barrier to seeking healthcare']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0040363', 'cui_str': 'Togo'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",162.0,0.176059,"UCTs had a protective effect on HAZ (DD = +0.25 z-scores, 95% confidence interval [CI]: 0.01-0.50, p = 0.039), which deteriorated in the control arm while remaining stable in the intervention arm, but had no impact on stunting (DD = -6.2 percentage points [pp], relative odds ratio [ROR]: 0.74, 95% CI: 0.51-1.06, p = 0.097).","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Briaux', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Martin-Prevel', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Carles', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fortin', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Kameli', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Adubra', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}, {'ForeName': 'Andréa', 'Initials': 'A', 'LastName': 'Renk', 'Affiliation': 'Paris School of Economics, UMR 8545, Paris, France.'}, {'ForeName': 'Yawavi', 'Initials': 'Y', 'LastName': 'Agboka', 'Affiliation': 'Projet de Développement Communautaire et Filets Sociaux, Ministère du Développement à la Base, Lomé, Togo.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Romedenne', 'Affiliation': 'UNICEF, Child Survival and Development, Lomé, Togo.'}, {'ForeName': 'Félicité', 'Initials': 'F', 'LastName': 'Mukantambara', 'Affiliation': 'UNICEF, Social protection, Lomé, Togo.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Van Dyck', 'Affiliation': 'The World Bank, Social Protection and Labor Global Practice, Washington, District of Columbia, United States of America.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Boko', 'Affiliation': 'The World Bank, Social Protection and Labor Global Practice, Country Office of Cotonou, Benin.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Becquet', 'Affiliation': 'University of Bordeaux, Inserm, Institut de Recherche pour le Développement, UMR 1219, Bordeaux Population Health Research Center, Team IDLIC, Bordeaux, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Savy', 'Affiliation': 'NUTRIPASS, French National Research Institute for Sustainable Development-University of Montpellier-Montpellier SupAgro, Montpellier, France.'}]",PLoS medicine,['10.1371/journal.pmed.1003388']
2250,33202169,"Effect of Domperidone on Breast Milk Production in Mothers of Sick Neonates: A Randomized, Double-Blinded, Placebo-Controlled Trial.","Objective:  Mothers of many preterm babies are unable to produce sufficient milk for their babies during the prolonged hospitalization. Domperidone stimulates the release of prolactin, thereby increasing breast milk production. The primary outcome was to study the efficacy of domperidone in augmenting breast milk production in mothers with lactation failure (LF). The secondary outcomes included the effect of domperidone on prolactin levels, adverse effects of domperidone, and outcome on breastfeeding rates at discharge.  Materials and Methods:  This was a randomized, double-blinded, placebo-controlled trial where mothers with LF were either allocated domperidone (10 mg) or placebo, 2 tablets three times a day for 14 days. Milk volumes were recorded daily for 14 days. Serum prolactin levels were measured at the start and at day 7 of study.  Results:  Out of 166 women eligible for the study, 119 (71.7%) mothers were able to increase their breast milk production without pharmacological treatment after being counseled on the advantages of human milk and proper breastfeeding management. Forty-seven mothers were finally enrolled in the study; 24 in the domperidone group (DG) and 23 in the placebo group (PG). Breast milk production increased from a baseline of 156 + 141.1 to 400.9 + 239.2 mL in the DG and increased from a baseline of 175.8 + 150.7 to 260.5 + 237.5 mL in the PG, after 14 days ( p  < 0.01). The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54) ng/mL, respectively, to 223.4 (49.79-280.2) ng/mL ( p  = 0.005) in the DG and 60.08 (14.31-132.14) ng/mL ( p  = 0.232) in the PG on the 7th day of treatment. No adverse effects were recorded. Ninety-five percent of babies in the DG were exclusively breastfeeding at hospital discharge, compared with 52.4% in the PG ( p  = 0.008).  Conclusion:  Domperidone treatment can result in an increase in breast milk production with no adverse effects. The study was registered with the Thai Clinical Trials Registry ID TCTR2020091008.",2020,The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54),"['Forty-seven mothers were finally enrolled in the study; 24 in the domperidone group (DG) and 23 in the placebo group (PG', '166 women eligible for the study, 119 (71.7', 'mothers with LF', 'Mothers of many preterm babies', 'mothers with lactation failure (LF', 'Mothers of Sick Neonates']","['placebo', 'Domperidone', 'domperidone', 'Placebo']","['Breast milk production', 'prolactin levels', 'adverse effects', 'breast milk production', 'Serum prolactin levels', 'prolactin levels, adverse effects of domperidone, and outcome on breastfeeding rates at discharge', 'Milk volumes', 'Breast Milk Production']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0152158', 'cui_str': 'Failure of lactation'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",166.0,0.509817,The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54),"[{'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Khorana', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Panrada', 'Initials': 'P', 'LastName': 'Wongsin', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Roongrawee', 'Initials': 'R', 'LastName': 'Torbunsupachai', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Wiboon', 'Initials': 'W', 'LastName': 'Kanjanapattanakul', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0234']
2251,33202219,"Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial.","BACKGROUND


Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.
METHODS


The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.
FINDINGS


Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).
INTERPRETATION


Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.
FUNDING


ACTION Study Group and AstraZeneca.",2020,"INTERPRETATION


Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days.","['1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group', 'stable coronary patients undergoing high-risk elective PCI', 'Eligible patients', '49 hospitals in France and Czech Republic', 'Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic', 'Between Jan 9, 2017, and May 28, 2020', '15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group', 'elective percutaneous coronary intervention (ALPHEUS']","['clopidogrel', 'Ticagrelor versus clopidogrel', 'ticagrelor']","['rate of minor bleeding', 'minor bleeding events', 'periprocedural myocardial necrosis', 'major bleeding', 'periprocedural ischaemic complications', 'composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",1910.0,0.14731,"INTERPRETATION


Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days.","[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'ACTION Study Group, Département de Cardiologie, CHU de Caen, Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Rangé', 'Affiliation': 'Département de Cardiologie, CH de Chartres, Chartres, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': 'Third Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Université de Paris, Department of Cardiology, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, INSERM U942, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'ACTION Study Group, Département de Cardiologie, CH de Bastia, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'Département de Cardiologie, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Département de Cardiologie, Clinique Sainte Clotilde, La Réunion, France.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Larrieu-Ardilouze', 'Affiliation': 'Service de Cardiologie, CHU de Poitiers, Poitiers, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Département de Cardiologie, Grand Hôpital de l'Est Francilien site Marne-La-Vallée, Marne-la-Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation Centre, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Université de Paris, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Blanchart', 'Affiliation': 'ACTION Study Group, Département de Cardiologie, CHU de Caen, Caen, France.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'University Hospital Brno, Medical Faculty of Masaryk University Brno, Brno, Czech Republic.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'ACTION Study Group, Unité de Recherche Clinique, Hôpital Fernand Widal (AP-HP), Paris, France; Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32236-4']
2252,33202263,"Attention bias modification in depression: A randomized trial using a novel, reward-based, eye-tracking approach.","BACKGROUND AND OBJECTIVES


Biased attention to negative information is a mechanism for risk and relapse in depression. Attentional bias modification (ABM) paradigms manipulate attention away from negative information to reduce this bias. ABM results have been mixed due to inconsistent methodologies and stimuli design. This randomized controlled trial used a novel approach to modifying attentional bias.
METHODS


An eye tracker manipulated stimuli in response to participants' fixations to preferentially reward attention to positive stimuli by obscuring or enhancing image quality of negative and positive stimuli, respectively. Participants with major depressive disorder completed three 35-min sessions of active (n = 20) or sham (n = 20) ABM training. Attentional bias, memory for emotional words, and mood were assessed pre- and post-training.
RESULTS


Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2  = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2  = 0.096). Active training participants remembered more happy than sad words in an emotional word learning task, indicating a distal transfer of training to emotional memory (p = .036, η p 2  = 0.11). Training did not significantly affect mood in the one-week trial.
LIMITATIONS


Future studies should build on this proof-of-principle study with larger sample sizes and more intensive treatment to explore which mechanisms of training may lead to improvements in mood.
CONCLUSIONS


Attention biases in depression are modifiable through reward-based, eye-tracking training. These data suggest generalizability of training to other cognitive faculties - recall for affective information.",2020,"RESULTS


Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2  = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2  = 0.096).",['Participants with major depressive disorder'],"['active (n\xa0=\xa020) or sham (n\xa0=\xa020) ABM training', 'Attentional bias modification (ABM']","['Attentional bias, memory for emotional words, and mood', 'negative attentional bias']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.153622,"RESULTS


Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2  = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2  = 0.096).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Woolridge', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada.""}, {'ForeName': 'Geoffrey W', 'Initials': 'GW', 'LastName': 'Harrison', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada.""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Best', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada; Department of Psychological Clinical Science, University of Toronto Scarborough Science Wing, Room SW427D 1265 Military Trail Toronto, Ontaro, M1C 1A4, Canada.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada. Electronic address: bowiec@queensu.ca.""}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101621']
2253,33202416,First-Phase Insulin and Amylin after Bariatric Surgery: A Prospective Randomized Trial on Patients with Insulin Resistance or Diabetes after Gastric Bypass or Sleeve Gastrectomy.,"BACKGROUND


Most patients with severe obesity show glucose intolerance. Early after sleeve gastrectomy (LSG) or gastric bypass (LRYGB), a marked amelioration in glycemic control occurs. The underlying mechanism is not yet clear.
OBJECTIVE


To determine whether the improvement in glycemic control on the level of endocrine pancreatic function is due to an increased first-phase insulin secretion comparing LRYGB to LSG.
SETTING


University of Basel Hospital and St. Clara Research Ltd., Basel, Switzerland.
METHODS


Sixteen morbidly obese patients with severe obesity and different degrees of insulin resistance were randomized to LSG or LRYGB, and islet cell functions were tested by intravenous glucose and intravenous arginine administration before and 4 weeks after surgery.
RESULTS


Fasting insulin and glucose levels and homeostasis model assessment insulin resistance were significantly lower in both groups after surgery compared to baseline, while no change was seen in fasting C-peptide, amylin, and glucagon. After intravenous glucose stimulation, no statistically significant pre- to postoperative change in area under the curve (AUC 0-60 min) was seen for insulin, glucagon, amylin, and C-peptide. No statistically significant pre- to postoperative change in incremental AUC for first-phase insulin release (AUC 0-10 min), second-phase insulin secretion (AUC 10-60 min), and insulin/glucose ratio could be shown in either group. Arginine-stimulated insulin and glucagon release showed no pre- to postoperative change.
CONCLUSION


Intravenous glucose and arginine administrations show no pre- to postoperative changes of insulin release, amylin, glucagon, or C-peptide concentrations, and no differences between LRYGB and LSG were found. The postoperative improvement in glycemic control is not caused by changes in endocrine pancreatic hormone secretion.",2020,"Fasting insulin and glucose levels and homeostasis model assessment insulin resistance were significantly lower in both groups after surgery compared to baseline, while no change was seen in fasting C-peptide, amylin, and glucagon.","['Patients with Insulin Resistance or Diabetes after Gastric Bypass or Sleeve Gastrectomy', 'patients with severe obesity show glucose intolerance', 'University of Basel Hospital and St. Clara Research Ltd., Basel, Switzerland', 'Sixteen morbidly obese patients with severe obesity and different degrees of insulin resistance']","['sleeve gastrectomy (LSG) or gastric bypass (LRYGB', 'First-Phase Insulin and Amylin after Bariatric Surgery']","['Fasting insulin and glucose levels and homeostasis model assessment insulin resistance', 'insulin/glucose ratio', 'insulin release, amylin, glucagon, or C-peptide concentrations', 'fasting C-peptide, amylin, and glucagon']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1136140', 'cui_str': 'Long-Term Depression, Neurophysiologic'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",16.0,0.0252244,"Fasting insulin and glucose levels and homeostasis model assessment insulin resistance were significantly lower in both groups after surgery compared to baseline, while no change was seen in fasting C-peptide, amylin, and glucagon.","[{'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Nussbaumer', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Anne Christin', 'Initials': 'AC', 'LastName': 'Meyer-Gerspach', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Peterli', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Department of Medicine, St. Claraspital, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Beglinger', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Chiappetta', 'Affiliation': 'Department of Obesity and Metabolic Surgery, Ospedale Evangelico Betania, Naples, Italy.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Drewe', 'Affiliation': 'Department of Pharmacology and Toxicology, University Hospital, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wölnerhanssen', 'Affiliation': 'University of Basel, Basel, Switzerland, bettina.woelnerhanssen@unibas.ch.'}]",Obesity facts,['10.1159/000511928']
2254,33203367,Cesarean delivery or induction of labor in pre-labor twin gestations: a secondary analysis of the twin birth study.,"BACKGROUND


In the Twin Birth Study, women at 32 0/7 -38 6/7  weeks of gestation, in whom the first twin was in cephalic presentation, were randomized to planned vaginal delivery or cesarean section. The study found no significant differences in neonatal or maternal outcomes in the two planned mode of delivery groups. We aimed to compare neonatal and maternal outcomes of twin gestations without spontaneous onset of labor, who underwent induction of labor or pre-labor cesarean section as the intervention of induction may affect outcomes.
METHODS


In this secondary analysis of the Twin Birth Study we compared those who had an induction of labor with those who had a pre-labor cesarean section. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity. Secondary outcome was a composite of maternal morbidity and mortality.
TRIAL REGISTRATION


NCT00187369.
RESULTS


Of the 2804 women included in the Twin Birth Study, a total of 1347 (48%) women required a delivery before a spontaneous onset of labor occurred: 568 (42%) in the planned vaginal delivery arm and 779 (58%) in the planned cesarean arm. Induction of labor was attempted in 409 (30%), and 938 (70%) had a pre-labor cesarean section. The rate of intrapartum cesarean section in the induction of labor group was 41.3%. The rate of the primary outcome was comparable between the pre-labor cesarean section group and induction of labor group (1.65% vs. 1.97%; p = 0.61; OR 0.83; 95% CI 0.43-1.62). The maternal composite outcome was found to be lower with pre-labor cesarean section compared to induction of labor (7.25% vs. 11.25%; p = 0.01; OR 0.61; 95% CI 0.41-0.91).
CONCLUSION


In women with twin gestation between 32 0/7 -38 6/7  weeks of gestation, induction of labor and pre-labor cesarean section have similar neonatal outcomes. Pre-labor cesarean section is associated with favorable maternal outcomes which differs from the overall Twin Birth Study results. These data may be used to better counsel women with twin gestation who are faced with the decision of interventional delivery.",2020,The rate of the primary outcome was comparable between the pre-labor cesarean section group and induction of labor group (1.65% vs. 1.97%; p = 0.61; OR 0.83; 95% CI 0.43-1.62).,"['twin gestations without spontaneous onset of labor, who underwent induction of labor or pre-labor cesarean section', 'pre-labor twin gestations', '2804 women included in the Twin Birth Study', 'Twin Birth Study we compared those who had an induction of labor with those who had a pre-labor cesarean section', 'Twin Birth Study, women at 32 0/7 -38 6/7  weeks of gestation, in whom the first twin was in cephalic presentation', 'counsel women with twin gestation', 'a total of 1347 (48%) women required a delivery before a spontaneous onset of labor occurred: 568 (42%) in the planned vaginal delivery arm and 779 (58%) in the planned cesarean arm']","['planned vaginal delivery or cesarean section', 'Cesarean delivery or induction of labor']","['pre-labor cesarean section', 'composite of fetal or neonatal death or serious neonatal morbidity', 'neonatal or maternal outcomes', 'composite of maternal morbidity and mortality', 'Induction of labor', 'rate of intrapartum cesarean section', 'rate of the primary outcome']","[{'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0233365', 'cui_str': 'Twin birth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",2804.0,0.19393,The rate of the primary outcome was comparable between the pre-labor cesarean section group and induction of labor group (1.65% vs. 1.97%; p = 0.61; OR 0.83; 95% CI 0.43-1.62).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dougan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gotha', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Melamed', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aviram', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Asztalos', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Anabusi', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jfr', 'Initials': 'J', 'LastName': 'Barrett', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mei-Dan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and the Department of Newborn & Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. eladmei@yahoo.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03369-x']
2255,33203385,Testing the effect of summer camp on excess summer weight gain in youth from low-income households: a randomized controlled trial.,"BACKGROUND


Children from racial and ethnic minority groups, low-income households, and those with overweight or obesity gain more weight during the summer than the school year. Summer day camps, which offer routine opportunities for physical activity and regular meal and snack times, have potential to mitigate excess weight gain. This randomized controlled trial was done to determine the feasibility and preliminary effectiveness of summer camp in preventing excess summer weight gain among youth from low-income households.
METHODS


Children, ages 6 to 12 years, were randomized to attend 8-weeks of summer day camp (CAMP) or to experience an unstructured summer as usual (SAU) in 2017-2018. Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes included changes in BMIz, engagement in moderate to vigorous physical activity (MVPA) and sedentary behavior, and diet quality and energy intake from the school year to summer. Multivariable linear mixed models were used to assess group differences.
RESULTS


Ninety-four participants were randomized to CAMP (n = 46) or SAU (n = 48), of whom 93.0 and 91.6% completed end of school and end of summer assessments, respectively. While CAMP participants attended only 50% of camp days offered, on average, they lost - 0.03 BMIz units while those in SAU gained 0.07 BMIz units over the summer (b = 0.10; p = .02). Group differences in change in energy intake from the school year to summer were borderline significant, as energy intake remained relatively unchanged in CAMP participants but increased among participants in SAU (p = 0.07).
CONCLUSIONS


Randomizing children to attend summer day camp or experience an unstructured summer as usual was effective in this low-income sample. Our findings support the potential for summer camps in mitigating excess summer weight gain. A larger randomized trial is needed explore efficacy, cost-effectiveness and longer-term effects of attending summer camp on weight and weight-related behaviors.
TRIAL REGISTRATION


ClinicalTrials.gov Registration: NCT04085965 (09/2019, retrospective registration).",2020,"Group differences in change in energy intake from the school year to summer were borderline significant, as energy intake remained relatively unchanged in CAMP participants but increased among participants in SAU (p = 0.07).
","['youth from low-income households', 'Children, ages 6 to 12\u2009years', 'Children from racial and ethnic minority groups, low-income households, and those with overweight or obesity gain more weight during the summer than the school year', 'Ninety-four participants were randomized to']","['summer camp', 'SAU', 'summer day camp (CAMP) or to experience an unstructured summer as usual (SAU', 'CAMP']","['weight and weight-related behaviors', 'retention, engagement and completion of midsummer measures', 'energy intake', 'changes in BMIz, engagement in moderate to vigorous physical activity (MVPA) and sedentary behavior, and diet quality and energy intake from the school year to summer']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}]",94.0,0.270374,"Group differences in change in energy intake from the school year to summer were borderline significant, as energy intake remained relatively unchanged in CAMP participants but increased among participants in SAU (p = 0.07).
","[{'ForeName': 'E Whitney', 'Initials': 'EW', 'LastName': 'Evans', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St, Providence, RI, 02903, USA. whitney_evans@brown.edu.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St, Providence, RI, 02903, USA.'}, {'ForeName': 'Denise F', 'Initials': 'DF', 'LastName': 'Pierre', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Hartford, CT, USA.'}, {'ForeName': 'Whitney C', 'Initials': 'WC', 'LastName': 'Howie', 'Affiliation': 'Department of Psychological & Brain Science, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Brinker', 'Affiliation': 'School of Public Health, Brown University, Providence, RI, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St, Providence, RI, 02903, USA.'}]",BMC public health,['10.1186/s12889-020-09806-y']
2256,33203399,"A randomized phase II trial evaluating the addition of low dose, short course sunitinib to docetaxel in advanced solid tumours.","BACKGROUND


We previously reported that low-dose, short-course sunitinib prior to neoadjuvant doxorubicin-cyclophosphamide (AC) normalised tumour vasculature and improved perfusion, but resulted in neutropenia and delayed subsequent cycles in breast cancer patients. This study combined sunitinib with docetaxel, which has an earlier neutrophil nadir than AC.
METHODS


Patients with advanced solid cancers were randomized 1:1 to 3-weekly docetaxel 75 mg/m 2 , with or without sunitinib 12.5 mg daily for 7 days prior to docetaxel, stratified by primary tumour site. Primary endpoints were objective-response (ORR:CR + PR) and clinical-benefit rate (CBR:CR + PR + SD); secondary endpoints were toxicity and progression-free-survival (PFS).
RESULTS


We enrolled 68 patients from 2 study sites; 33 received docetaxel-sunitinib and 35 docetaxel alone, with 33 breast, 25 lung and 10 patients with other cancers. There was no difference in ORR (30.3% vs 28.6%, p = 0.432, odds-ratio [OR] 1.10, 95% CI 0.38-3.18); CBR was lower in the docetaxel-sunitinib arm (48.5% vs 71.4%, p = 0.027 OR 0.37, 95% CI 0.14-1.01). Median PFS was shorter in the docetaxel-sunitinib arm (2.9 vs 4.9 months, hazard-ratio [HR] 2.00, 95% CI 1.15-3.48, p = 0.014) overall, as well as in breast (4.2 vs 5.6 months, p = 0.048) and other cancers (2.0 vs 5.3 months, p = 0.009), but not in lung cancers (2.9 vs 4.1 months, p = 0.597). Median OS was similar in both arms overall (9.9 vs 10.5 months, HR 0.92, 95% CI 0.51-1.67, p = 0.789), and in the breast (18.9 vs 25.8 months, p = 0.354), lung (7.0 vs 6.7 months, p = 0.970) and other cancers (4.5 vs 8.8 months, p = 0.449) subgroups. Grade 3/4 haematological toxicities were lower with docetaxel-sunitinib (18.2% vs 34.3%, p = 0.132), attributed to greater discretionary use of prophylactic G-CSF (90.9% vs 63.0%, p = 0.024). Grade 3/4 non-haematological toxicities were similar (12.1% vs 14.3%, p = 0.792).
CONCLUSIONS


The addition of sunitinib to docetaxel was well-tolerated but did not improve outcomes. The possible negative impact in metastatic breast cancer patients is contrary to results of adding sunitinib to neoadjuvant AC. These negative results suggest that the intermittent administration of sunitinib in the current dose and schedule with docetaxel in advanced solid tumours, particularly breast cancers, is not beneficial.
TRIAL REGISTRATION


The study was registered ( NCT01803503 ) prospectively on clinicaltrials.gov on 4th March 2013.",2020,"Grade 3/4 haematological toxicities were lower with docetaxel-sunitinib (18.2% vs 34.3%, p = 0.132), attributed to greater discretionary use of prophylactic G-CSF (90.9% vs 63.0%, p = 0.024).","[' with 33 breast, 25 lung and 10 patients with other cancers', '68 patients from 2 study sites; 33 received', 'metastatic breast cancer patients', 'advanced solid tumours', 'Patients with advanced solid cancers', 'breast cancer patients']","['doxorubicin-cyclophosphamide (AC', 'docetaxel 75\u2009mg/m 2 , with or without sunitinib 12.5\u2009mg daily for 7\u2009days prior to docetaxel', 'docetaxel-sunitinib and 35 docetaxel alone', 'docetaxel', 'docetaxel-sunitinib']","['Grade 3/4 haematological toxicities', 'lung cancers', 'Median PFS', 'ORR', 'Grade 3/4 non-haematological toxicities', 'objective-response (ORR:CR\u2009+\u2009PR) and clinical-benefit rate (CBR:CR\u2009+\u2009PR\u2009+\u2009SD); secondary endpoints were toxicity and progression-free-survival (PFS', 'CBR', 'Median OS']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1702438', 'cui_str': 'sunitinib 12.5 MG [Sutent]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",68.0,0.13155,"Grade 3/4 haematological toxicities were lower with docetaxel-sunitinib (18.2% vs 34.3%, p = 0.132), attributed to greater discretionary use of prophylactic G-CSF (90.9% vs 63.0%, p = 0.024).","[{'ForeName': 'Yvonne L E', 'Initials': 'YLE', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Gwo Fuang', 'Initials': 'GF', 'LastName': 'Ho', 'Affiliation': 'University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Sundar', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, Singapore, Singapore.'}, {'ForeName': 'Wei Peng', 'Initials': 'WP', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Samuel G W', 'Initials': 'SGW', 'LastName': 'Ow', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Joline S J', 'Initials': 'JSJ', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Phyu Pyar', 'Initials': 'PP', 'LastName': 'Soe', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Cancer Science Institute, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Boon Cher', 'Initials': 'BC', 'LastName': 'Goh', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore.'}, {'ForeName': 'Soo-Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Level 7, NUHS Tower Block, 1E Kent Ridge Road, Singapore, 119228, Singapore. csilsc@nus.edu.sg.'}]",BMC cancer,['10.1186/s12885-020-07616-4']
2257,33203405,"Screening and patient-tailored care for emotional and cognitive problems compared to care as usual in patients discharged home after ischemic stroke (ECO-stroke): a protocol for a multicenter, patient-blinded, cluster randomized controlled trial.","BACKGROUND


Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke.
METHODS / DESIGN


A multicenter, patient-blinded, cluster randomized controlled trial will be performed. Centers will be randomized (1:1) to the intervention group or the usual care group. Patients (> 18 years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included. In the intervention group, patients will receive a short, individualized, semi-structured consultation by specialized nurses in addition to usual care. This consultation includes 1) screening for cognitive and emotional problems, 2) screening for restrictions in participation, 3) promotion of self-management strategies and 4) a decision tool for referral to rehabilitation services. The intervention will be performed approximately 6 weeks after the stroke at the neurology outpatient clinics and will take approximately 60 min. The control group will receive care as usual. Both groups will be followed-up at 6 weeks, 3 months and 12 months after stroke. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months. A cost-effectiveness analysis and process evaluation will be performed alongside.
DISCUSSION


This trial is the first to evaluate clinical effectiveness, cost-effectiveness and implementation of screening and patient-tailored care for cognitive and emotional problems compared to care as usual in patients discharged home after ischemic stroke. Potentially, this will improve the outcomes for patients with frequently occurring cognitive and emotional problems after stroke.
TRIAL REGISTRATION


Netherlands Trial Register: NL7295 , registered 25 September 2018.",2020,The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months.,"['patients with frequently occurring cognitive and emotional problems after stroke', 'patients discharged home after ischemic stroke\xa0(ECO-stroke', 'patients discharged home after ischemic stroke', 'Patients (>\u200918\u2009years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included', 'Ischemic stroke patients']","['Screening and patient-tailored care', 'usual care group']",['level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C2675227', 'cui_str': 'Endocrine-Cerebroosteodysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",,0.123148,The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months.,"[{'ForeName': 'J P L', 'Initials': 'JPL', 'LastName': 'Slenders', 'Affiliation': 'Department of Neurology, Amsterdam UMC, Amsterdam, the Netherlands. j.p.l.slenders@olvg.nl.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Van den Berg-Vos', 'Affiliation': 'Department of Neurology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'van Heugten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience (FPN), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'J M A', 'Initials': 'JMA', 'LastName': 'Visser-Meily', 'Affiliation': 'Department of Rehabilitation, Physical Therapy Science & Sports, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'S M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'Department of Health Services Research, Maastricht University, Care and Public Health Research Institute (CAPHRI) of the Faculty of Health, Medicine and Life Sciences, Maastricht, the Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'de Man-van Ginkel', 'Affiliation': 'Department of Nursing Science, Julius Center for Health Science and Primary Care & UMC Utrecht Brain Center, University Medical Center Utrecht, University Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'V I H', 'Initials': 'VIH', 'LastName': 'Kwa', 'Affiliation': 'Department of Neurology, OLVG, Amsterdam, the Netherlands.'}]",BMC health services research,['10.1186/s12913-020-05902-2']
2258,33203477,Evaluating the impact of biannual school-based and community-wide treatment on urogenital schistosomiasis in Niger.,"BACKGROUND


The Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) coordinated a five-year study implemented in several countries, including Niger, to provide an evidence-base for programmatic decisions regarding cost-effective approaches to preventive chemotherapy for schistosomiasis control.
METHODS


This was a cluster-randomised trial investigating six possible combinations of annual or biannual community-wide treatment (CWT), school-based treatment (SBT), and holidays from mass treatment over four years. The most intense arm involved two years of annual CWT followed by 2 years of biannual CWT, while the least intensive arm involved one year of annual SBT followed by a year without treatment and two more years of annual SBT. The primary outcome of interest was prevalence and intensity of Schistosoma haematobium among 100 children aged 9-12 years sampled each year. In addition, 100 children aged 5-8 years in their first year of school and 50 adults (aged 20-55 years) were tested in the first and final fifth year of the study.
RESULTS


In total, data were collected from 167,500 individuals across 225 villages in nine districts within the Niger River valley, Western Niger. Overall, the prevalence of S. haematobium decreased from baseline to Year 5 across all study arms. The relative reduction of prevalence was greater in biannual compared with annual treatment across all arms; however, the only significant difference was seen in areas with a high starting prevalence. Although adults were not targeted for treatment in SBT arms, a statistically significant decrease in prevalence among adults was seen in moderate prevalence areas receiving biannual (10.7% to 4.8%) SBT (P < 0.001). Adults tested in the annual SBT group also showed a decrease in prevalence between Year 1 and Year 5 (12.2% to 11.0%), but this difference was not significant.
CONCLUSIONS


These findings are an important consideration for schistosomiasis control programmes that are considering elimination and support the idea that scaling up the frequency of treatment rounds, particularly in areas of low prevalence, will not eliminate schistosomiasis. Interestingly, the finding that prevalence decreased among adults in SBT arms suggests that transmission in the community can be reduced, even where only school children are being treated, which could have logistical and cost-saving implications for the national control programmes.",2020,"The relative reduction of prevalence was greater in biannual compared with annual treatment across all arms; however, the only significant difference was seen in areas with a high starting prevalence.","['167,500 individuals across 225 villages in nine districts within the Niger River valley, Western Niger', '100 children aged 9-12 years sampled each year', 'urogenital schistosomiasis in Niger', '100 children aged 5-8 years in their first year of school and 50 adults (aged 20-55 years']","['annual or biannual community-wide treatment (CWT), school-based treatment (SBT', 'biannual school-based and community-wide treatment']","['prevalence and intensity of Schistosoma haematobium', 'prevalence of S. haematobium', 'relative reduction of prevalence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0028074', 'cui_str': 'Niger'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1704430', 'cui_str': 'Urinary schistosomiasis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036316', 'cui_str': 'Schistosoma haematobium'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",100.0,0.0761165,"The relative reduction of prevalence was greater in biannual compared with annual treatment across all arms; however, the only significant difference was seen in areas with a high starting prevalence.","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Phillips', 'Affiliation': 'London Centre for Neglected Tropical Disease Research (LCNTDR), Department of Infectious Disease Epidemiology, Imperial College London, London, UK. a.phillips05@imperial.ac.uk.'}, {'ForeName': 'Zilahatou', 'Initials': 'Z', 'LastName': 'Tohon', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Neerav A', 'Initials': 'NA', 'LastName': 'Dhanani', 'Affiliation': 'Schistosomiasis control Initiative (SCI), Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Sofo', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Gnandou', 'Affiliation': 'Ministère de la Santé, Niamey, Niger.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Sidikou', 'Affiliation': 'Hôpital National de Niamey rond-point Hôpital, BP 238, Niamey, Niger.'}, {'ForeName': 'Adamou Garba', 'Initials': 'AG', 'LastName': 'Noma', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Bassirou', 'Initials': 'B', 'LastName': 'Madougou', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Oumarou', 'Initials': 'O', 'LastName': 'Alto', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Hannatou', 'Initials': 'H', 'LastName': 'Sebangou', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Kader M', 'Initials': 'KM', 'LastName': 'Halilou', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Roumanatou', 'Initials': 'R', 'LastName': 'Andia', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Garba', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fenwick', 'Affiliation': 'Schistosomiasis control Initiative (SCI), Department of Infectious Disease Epidemiology, Imperial College London, London, UK.'}, {'ForeName': 'Amina A', 'Initials': 'AA', 'LastName': 'Hamidou', 'Affiliation': ""Aménagement et Lutte (RISEAL NIGER), Réseau International Schistosomiases Environnement, Avenue de l'indépendance, BP. 13724, Niamey, Niger.""}]",Parasites & vectors,['10.1186/s13071-020-04411-9']
2259,33203525,The association between frequency of e-cigarette use and long-term smoking cessation outcomes among treatment-seeking smokers receiving a behavioral intervention.,"INTRODUCTION


A growing body of literature suggests daily, but not non-daily, e-cigarette use is associated with greater odds of quitting combustible cigarettes in the general adult population. However, it is unknown if these findings generalize to treatment-seeking smokers who are receiving a behavioral intervention. Our primary aim was to examine whether frequency of e-cigarette use was associated with subsequent cessation among treatment-seeking smokers who are receiving a behavioral smoking cessation intervention.
METHODS


Participants (N = 2637) enrolled in a RCT of web-based smoking treatments reported their use of e-cigarettes at baseline, 3-, and 6-months. Three groups were created based on e-cigarette use: (1) non-users, (2) intermittent users, and (3) daily users. The primary outcome was complete-case, self-reported 30-day point prevalence abstinence at 12 months.
RESULTS


Compared to non-users, daily e-cigarette users were significantly less likely to be abstinent (21.39 % vs. 29.68 %; p = .006). Quit rates for intermittent users (24.56 %) were not significantly different from non-users (p = .092). Nicotine dependence moderated the results such that among smokers with low nicotine dependence, those who used e-cigarettes (intermittently or daily) were less likely to quit than non-users; these differences were not significant among those with high nicotine dependence. Post hoc analyses indicated that initiating daily e-cigarette use after baseline, but not daily e-cigarette use at baseline, was associated with lower odds of cessation.
CONCLUSIONS


Daily e-cig use may be associated with lower odds of quitting smoking among treatment-seeking smokers, particularly among those with lower nicotine dependence and who initiate daily use after beginning an intervention.",2020,Quit rates for intermittent users (24.56 %) were not significantly different from non-users (p = .092).,"['Participants (N\u2009=\u20092637) enrolled in a RCT of web-based smoking treatments reported their use of e-cigarettes at baseline, 3-, and 6-months', 'treatment-seeking smokers who are receiving a behavioral smoking cessation intervention', 'treatment-seeking smokers receiving a']",['behavioral intervention'],"['quitting smoking', 'Quit rates', 'complete-case, self-reported 30-day point prevalence abstinence']","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",2637.0,0.015294,Quit rates for intermittent users (24.56 %) were not significantly different from non-users (p = .092).,"[{'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232, Seattle, WA 98109, USA. Electronic address: nlwatson@fredhutch.org.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232, Seattle, WA 98109, USA.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-B232, Seattle, WA 98109, USA; Department of Psychology, University of Washington, 119A Guthrie Hall, Seattle, WA, 98195, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108394']
2260,33203537,Effects of an elastic resistance band exercise program on kinetics and muscle activities during walking in young adults with genu valgus: A double-blinded randomized controlled trial.,"BACKGROUND


This double-blinded randomized-controlled-trial aimed to identify the effects of an elastic band resistance training on walking kinetics and muscle activities in young adults with genu valgus.
METHODS


Forty-two male young adults aged 22.5(2.7) years with genu valgus were randomly allocated to two experimental groups. The intervention group (n = 21) conducted a 14-weeks elastic band resistance training. The control group was passive during the intervention period and received the same treatment after the post-tests. Pre and post training, ground reaction forces and lower limb muscle activities were recorded during walking.
FINDINGS


Results revealed significant group-by-time interactions for peak medial ground reaction force and time-to-peak for posterior ground reaction force in favor of the intervention group (p < 0.012; d = 0.83-3.76). Resistance training with elastic bands resulted in significantly larger peak medial ground reaction force (p < 0.001; d = 1.45) and longer time-to-peak for posterior ground reaction force (p < 0.001; d = 1.85). Finding showed significant group-by-time interactions for peak positive free moment amplitudes in favor of the intervention group (p < 0.001; d = 1.18-2.02). Resistance training resulted in a lower peak positive free moment amplitude (p = 0.001; d = 1.46). With regards to muscle activities, the analysis revealed significant group-by-time interactions for rectus femoris and gluteus medius activities during the push-off phase in favor of the intervention group (p < 0.038; d = 0.68-0.89). Resistance training induced higher rectus femoris (p = 0.038; d = 0.84) and gluteus medius (p = 0.007; d = 0.54) activities.
INTERPRETATION


This study proved the effectiveness of resistance training using elastic bands on kinetics and muscle activities during walking in male adults with genu valgus disorder. Given that this training regime is low cost, effective, and easy-to-administer, we suggest that it should be implemented as a rehabilitative or preventive means for young adults with genu valgus.",2020,Resistance training with elastic bands resulted in significantly larger peak medial ground reaction force (p < 0.001; d = 1.45) and longer time-to-peak for posterior ground reaction force (p < 0.001; d = 1.85).,"['Forty-two male young adults aged 22.5(2.7', 'male adults with genu valgus disorder', 'years with genu valgus', 'young adults with genu valgus']","['resistance training', 'elastic resistance band exercise program', '14-weeks elastic band resistance training', 'Resistance training', 'elastic band resistance training']","['walking kinetics and muscle activities', 'kinetics and muscle activities', 'larger peak medial ground reaction force', 'Pre and post training, ground reaction forces and lower limb muscle activities', 'peak positive free moment amplitude', 'peak medial ground reaction force and time-to-peak for posterior ground reaction force', 'longer time-to-peak for posterior ground reaction force']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0576093', 'cui_str': 'Knee joint valgus deformity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442810', 'cui_str': 'Large peak'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",42.0,0.137398,Resistance training with elastic bands resulted in significantly larger peak medial ground reaction force (p < 0.001; d = 1.45) and longer time-to-peak for posterior ground reaction force (p < 0.001; d = 1.85).,"[{'ForeName': 'AmirAli', 'Initials': 'A', 'LastName': 'Jafarnezhadgero', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Ghorbanloo', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Fatollahi', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Valdeci Carlos', 'Initials': 'VC', 'LastName': 'Dionisio', 'Affiliation': 'Department of Physical Therapy Course, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany. Electronic address: urs.granacher@uni-potsdam.de.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105215']
2261,33203542,Cost effectiveness of SEEK: A primary care-based child maltreatment prevention model.,"BACKGROUND


Funding for prevention interventions is often quite limited. Cost-related assessments are important to best allocate prevention funds.
OBJECTIVES


To determine the (1) overall cost for implementing the Safe Environment for Every Kid (SEEK) model, (2) cost of implementation per child, and (3) cost per case of maltreatment averted.
DESIGN


Cost-effective analysis of a randomized controlled trial.
PARTICIPANTS AND SETTING


102 pediatric providers at 18 pediatric primary care practices. 924 families with children < 6 years receiving care by those providers.
METHODS


Practices and their providers were randomized to either SEEK training and implementation or usual care. Families in SEEK and control practices were recruited for evaluation. Rates of psychological and physical abuse were calculated by parent self-report 12 months following recruitment. Model costs were calculated including salaries for team members, provider time for training and booster sessions, and development and distribution of materials.
RESULTS


Implementing SEEK in all 18 practices would have cost approximately $265,892 over 2.5 years; $3.59 per child per year; or $305.58 ($229.18-$381.97) to prevent one incident. Based on a very conservative cost estimate of $2779 per maltreatment incident, SEEK would save an estimated $2,151,878 in health care costs for 29,610 children.
CONCLUSIONS


The SEEK model is cost saving. Cost per case of psychological and physical abuse averted were significantly lower than the short-term costs of medical and mental health care for maltreated children. SEEK model expansion has the potential to significantly decrease medical, mental health, and other related costs associated with maltreatment.",2020,"SEEK model expansion has the potential to significantly decrease medical, mental health, and other related costs associated with maltreatment.","['102 pediatric providers at 18 pediatric primary care practices', 'Practices and their providers', '924 families with children < 6 years receiving care by those providers', '29,610 children']","['SEEK', 'SEEK training and implementation or usual care']","['Model costs', 'provider time for training and booster sessions, and development and distribution of materials', 'Rates of psychological and physical abuse', 'Cost per case of psychological and physical abuse averted']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0557723', 'cui_str': 'Safe environment'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",924.0,0.0338686,"SEEK model expansion has the potential to significantly decrease medical, mental health, and other related costs associated with maltreatment.","[{'ForeName': 'Wendy G', 'Initials': 'WG', 'LastName': 'Lane', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, 660 W. Redwood St., Baltimore, MD, 21201, USA; Department of Pediatrics, University of Maryland School of Medicine, 520 W. Lombard St., Baltimore, MD, 21201, USA. Electronic address: wlane@som.umaryland.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Dubowitz', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 520 W. Lombard St., Baltimore, MD, 21201, USA. Electronic address: hdubowitz@som.umaryland.edu.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Frick', 'Affiliation': 'Johns Hopkins Carey Business School, 100 International Drive, Baltimore, MD, 21202, USA. Electronic address: kfrick@jhu.edu.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Semiatin', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, 520 W. Lombard St., Baltimore, MD, 21201, USA. Electronic address: semiatin@gmail.com.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, 660 W. Redwood St., Baltimore, MD, 21201, USA. Electronic address: lmagder@som.umaryland.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104809']
2262,33210382,A phase Ib study of NUC-1031 in combination with cisplatin for the first-line treatment of patients with advanced biliary tract cancer (ABC-08).,"BACKGROUND


Cisplatin/gemcitabine is standard 1st-line treatment for patients with advanced biliary tract cancer (ABC). NUC-1031 (phosphoramidate transformation of gemcitabine) is designed to enhance efficacy by maximising intra-tumoural active metabolites.
METHODS


Patients with untreated ABC, ECOG-PS 0-1 received NUC-1031 (625 or 725mg/m 2  ) and cisplatin (25mg/m 2  ) on days 1 and 8, every 21 days.
OBJECTIVES


safety and maximum tolerated dose (primary); and ORR, pharmacokinetics, PFS and OS (secondary).
RESULTS


Twenty-one patients (median age 61 years, n=13 male; 17 cholangiocarcinoma, 2 ampullary and 2 gallbladder cancer) received NUC-1031 625mg/m 2  (n=8 and expansion n=7; median 6 cycles) or 725mg/m 2  (n=6; median 7.5 cycles). Treatment was well tolerated; most common treatment-emergent grade 3-4 adverse-events occurring in >1 patient with 625mg/m 2  NUC-1031 were increased GGT: 40%, ALT: 20%, bilirubin: 13%, neutropenia: 27%, decreased WCC: 20%, thrombocytopenia: 13%, nausea: 13%, diarrhea: 13%, fatigue: 13%, and thrombus: 20% and with 725mg/m 2  , increased GGT: 67% and fatigue: 33%. NUC-1031 725mg/m 2  was selected as the recommended dose with cisplatin in ABC. ORR: 33% (1 CR, 6 PRs), DCR 76%, median PFS 7.2 months (95%-CI 4.3-10.1), median OS 9.6 months (95%-CI 6.7-13.1). The median plasma AUC 0-24  and C max  estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively).
CONCLUSIONS


This is the first study reporting on the combination of NUC-1031 with cisplatin in ABC and demonstrated a favourable safety profile; 725mg/m 2  NUC-1031 in combination with cisplatin is undergoing phase III trial evaluation in ABC. ClinicalTrials.gov reference: NCT02351765, EudraCT: 2015-000100-26 IMPLICATIONS FOR PRACTICE: The prognosis for patients with advanced biliary tract cancer (ABC) is approximately one year and new treatment options are required. The cisplatin/gemcitabine combination is standard first-line treatment for patients with ABC. NUC-1031 is a phosphoramidate transformation of gemcitabine and is designed to enhance efficacy by maximising intra-tumoural active metabolites. This phase Ib study (ABC-08) demonstrated a favourable safety profile of NUC-1031 in combination with cisplatin for the first-line treatment of patients with ABC, and 725mg/m2 NUC-1031 was recommended in combination with cisplatin for phase III trial evaluation; the NuTide:121 global randomised study is currently enrolling.",2020,"The median plasma AUC 0-24  and C max  estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively).
","['Twenty-one patients (median age 61\u2009years, n=13 male; 17 cholangiocarcinoma, 2 ampullary and 2 gallbladder cancer', 'patients with ABC', 'patients with ABC, and 725mg', 'patients with advanced biliary tract cancer (ABC', 'patients with advanced biliary tract cancer (ABC-08', 'Patients with untreated ABC, ECOG-PS 0-1 received']","['NUC-1031 with cisplatin', 'Cisplatin/gemcitabine', 'NUC-1031 (phosphoramidate transformation of gemcitabine', 'cisplatin/gemcitabine', 'cisplatin', 'ORR', 'NUC-1031', 'gemcitabine', 'NUC-1031 ', 'EudraCT']","['diarrhea', 'ORR, pharmacokinetics, PFS and OS (secondary', 'nausea', 'median plasma AUC 0-24  and C max  estimates', 'tolerated', 'neutropenia']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}]","[{'cui': 'C3640933', 'cui_str': 'NUC-1031'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0896246', 'cui_str': 'phosphoramidate'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",,0.0445132,"The median plasma AUC 0-24  and C max  estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively).
","[{'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Division of Cancer Sciences, University of Manchester Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre and Liverpool Experimental Cancer Medicine Centre, Liverpool, UK.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'Clatterbridge Cancer Centre and Liverpool Experimental Cancer Medicine Centre, Liverpool, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Ryder', 'Affiliation': 'Manchester Clinical Trials Unit, University of Manchester, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Manchester Clinical Trials Unit, University of Manchester, Manchester, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gnanaranjan', 'Affiliation': 'Barts Cancer Institute-Queen Mary University of London, London, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ghazaly', 'Affiliation': 'Barts Cancer Institute-Queen Mary University of London, London, UK.'}, {'ForeName': 'Trj', 'Initials': 'T', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, UK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester Manchester, UK.'}]",The oncologist,['10.1002/onco.13598']
2263,33210408,"Influence of a low-dose supplementation of curcumagalactomannoside complex (CurQfen) in knee osteoarthritis: A randomized, open-labeled, active-controlled clinical trial.","A 6-week, randomized, open-label, active-controlled clinical trial was conducted to evaluate the influence of a low-dose curcumagalactomannosides (CGM) (400 mg once daily) in OA subjects. The treatment was compared with a standard combination of 500 mg glucosamine hydrochloride (GLN) and 415 mg chondroitin sulphate (CHN), supplied as a single oral dose twice a day. Out of 84 subjects randomized, 72 subjects who have completed the study were evaluated for the safety and efficacy of the treatments at baseline and subsequent visits (day 28 and 42), by measuring walking performance, VAS, KPS, and WOMAC scores. CGM exhibited 47.02, 21.43, and 206% improvement in VAS, KPS, and walking performance, respectively, compared to the baseline. Similarly, there was 31.17, 32.93, 36.44, and 35% improvement in the pain, stiffness, physical function, and total WOMAC scores. CGM also caused a substantial reduction in the serum inflammatory marker levels. The results indicate that a short-term supplementation of a low dosage CGM exerted superior beneficial effects than a high-dosage CHN-GLN combination in alleviating the pain and symptoms of OA subjects. Further clinical trials of extended duration in a larger population is required to substantiate the efficacy of CGM in the long-term management of OA.",2020,"CGM exhibited 47.02, 21.43, and 206% improvement in VAS, KPS, and walking performance, respectively, compared to the baseline.","['OA subjects', 'knee osteoarthritis', '84 subjects randomized, 72 subjects who have completed the study']","['curcumagalactomannoside complex (CurQfen', 'CGM', 'low-dose curcumagalactomannosides (CGM', 'glucosamine hydrochloride (GLN) and 415\u2009mg chondroitin sulphate (CHN']","['pain, stiffness, physical function, and total WOMAC scores', 'safety and efficacy', 'VAS, KPS, and walking performance', 'walking performance, VAS, KPS, and WOMAC scores', 'serum inflammatory marker levels']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0771903', 'cui_str': 'Glucosamine hydrochloride'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",84.0,0.0363765,"CGM exhibited 47.02, 21.43, and 206% improvement in VAS, KPS, and walking performance, respectively, compared to the baseline.","[{'ForeName': 'Jestin V', 'Initials': 'JV', 'LastName': 'Thomas', 'Affiliation': 'Leads Clinical Research & Bio Services Pvt. Ltd., Bangalore, India.'}, {'ForeName': 'Thozhuthum Parambil', 'Initials': 'TP', 'LastName': 'Smina', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'Aman Hospital and Research Center, Vadodara, India.'}, {'ForeName': 'Ajaikumar B', 'Initials': 'AB', 'LastName': 'Kunnumakkara', 'Affiliation': 'Department of Biosciences and Bioengineering, Indian Institute of Technology Guwahati, Guwahati, India.'}, {'ForeName': 'Balu', 'Initials': 'B', 'LastName': 'Maliakel', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}, {'ForeName': 'Ratheesh', 'Initials': 'R', 'LastName': 'Mohanan', 'Affiliation': 'Department of Biochemistry, St. Thomas College, Pala, Kottayam, India.'}, {'ForeName': 'Illathu Madhavamenon', 'Initials': 'IM', 'LastName': 'Krishnakumar', 'Affiliation': 'R&D Centre, Akay Natural Ingredients Pvt. Ltd., Cochin, India.'}]",Phytotherapy research : PTR,['10.1002/ptr.6907']
2264,33210425,Target-controlled infusion of Propofol and Remifentanil in a child with recurrent rhabdomyolysis secondary to LPIN1 deficiency.,,2020,,['child with recurrent rhabdomyolysis secondary to LPIN1 deficiency'],['Propofol and Remifentanil'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0035410', 'cui_str': 'Rhabdomyolysis'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]",[],,0.0121093,,"[{'ForeName': 'Balvindar', 'Initials': 'B', 'LastName': 'Kaur', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital Melbourne, Parkville, Vic., Australia.""}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Rattalino', 'Affiliation': ""Department of Anaesthesia and Pain Management, The Royal Children's Hospital Melbourne, Parkville, Vic., Australia.""}]",Paediatric anaesthesia,['10.1111/pan.13887']
2265,33210434,Identification of novel step-up regimen of intralesional triamcinolone acetonide in scalp alopecia areata based on a double-blind randomized controlled trial.,"BACKGROUND


Although intralesional triamcinolone acetonide(TA) is the most commonly prescribed treatment for localized alopecia areata(AA), the literature regarding the optimal concentration for attaining better efficacy with the most acceptable side effects is scarce.
OBJECTIVES


To compare hair regrowth and local side effects of various concentrations of intralesional TA in scalp AA using clinical and dermoscopic parameters.
MATERIAL AND METHODS


A double-blind randomized control trial with four treatment groups [10-mg/ml, 5-mg/ml, 2.5-mg/ml TA and normal saline (NS)] was conducted between March-2018 and August-2019. After recruitment, each AA patch was divided into quadrants and randomized before first injection. Injections were given and outcome parameters were analyzed every 4-weekly till 12-weeks. Statistical analysis was done by R software employing Generalised Estimation Equation. p-value <0.05 was considered significant.
RESULTS


Out of 105-patients (168-AA patches), 75-patients (121-patches) completed the study. Hair regrowth scale (RGS) of all TA concentrations were better than NS group (p<0.001). Other parameters such as quadrants with poor clinical response and dermoscopic disease activity signs were also favorable in TA groups in comparison to NS. However the evidence of atrophy and telangiectasia was maximum in 10-mg/ml group.
CONCLUSION


10-mg/ml TA showed a comparatively better response at the cost of increased adverse effects. Based on the clinical benefit and adverse risk assessment from our study, it may be better to start with 2.5-mg/ml intralesional TA in limited scalp AA patients. It can be implied that the concentration of TA can be increased as a step-up regimen based on the serial clinical and dermoscopic response. This article is protected by copyright. All rights reserved.",2020,Hair regrowth scale (RGS) of all TA concentrations were better than NS group (p<0.001).,['scalp alopecia areata'],"['intralesional triamcinolone acetonide', 'intralesional triamcinolone acetonide(TA', '10-mg/ml, 5-mg/ml, 2.5-mg/ml TA and normal saline (NS', 'intralesional TA']","['atrophy and telangiectasia', 'clinical response and dermoscopic disease activity signs', 'Hair regrowth scale (RGS) of all TA concentrations', 'adverse effects']","[{'cui': 'C0574769', 'cui_str': 'Loss of scalp hair'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.332477,Hair regrowth scale (RGS) of all TA concentrations were better than NS group (p<0.001).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bandhala Rajan', 'Affiliation': 'Department of Dermatology, Venereology & Leprology, All India Institute of Medical Sciences, Jodhpur.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Dermatology, Venereology & Leprology, All India Institute of Medical Sciences, Jodhpur.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology, Venereology & Leprology, All India Institute of Medical Sciences, Jodhpur.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Budania', 'Affiliation': 'Department of Dermatology, Venereology & Leprology, All India Institute of Medical Sciences, Jodhpur.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Bains', 'Affiliation': 'Department of Dermatology, Venereology & Leprology, All India Institute of Medical Sciences, Jodhpur.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Thirunavukkarasu', 'Affiliation': 'Department of Community medicine and Family medicine, All India Institute of Medical Sciences, Jodhpur.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar-M', 'Affiliation': 'Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh.'}]",Dermatologic therapy,['10.1111/dth.14555']
2266,33210445,Use of the single-item Patient Global Impression-Severity scale as a self-reported assessment of insomnia severity.,"We evaluated a single-item Patient Global Impression-Severity (PGI-S) scale for assessing insomnia severity during the clinical development programme for suvorexant. The analyses used data from two randomised, double-blind, placebo-controlled, 3-month, Phase III clinical trials of suvorexant in patients with Diagnostic and Statistical Manual of Mental Disorders IV criteria insomnia. Patients assessed insomnia severity during the previous week using the PGI-S, a one-item questionnaire containing six response options ranging from 0 (none) to 5 (very severe), at baseline and at Week 2, and Months 1, 2, and 3 after randomisation. The seven-item Insomnia Severity Index (ISI) and other subjective and objective assessments were also completed by patients. PGI-S responses were compared primarily with the ISI using descriptive statistics and correlations. The PGI-S demonstrated favourable measurement characteristics (validity, reliability, responsiveness and sensitivity). PGI-S scores decreased from baseline to Month 3 in a similar pattern to the ISI total score, and the Spearman correlation coefficient between PGI-S and the ISI was .73. An improvement of ≥2 points on the PGI-S defined a treatment responder, based on comparison to the ISI definition of a responder (improvement of ≥6 points). Our present findings suggest that the PGI-S is a simple but valid, reliable, responsive, sensitive, and meaningful patient-reported assessment of insomnia severity. The PGI-S may be particularly useful as a companion outcome to sleep monitoring using wearable sleep devices or smartphones in at-home settings.",2020,"PGI-S scores decreased from baseline to Month 3 in a similar pattern to the ISI total score, and the Spearman correlation coefficient between PGI-S and the ISI was .73.",['patients with Diagnostic and Statistical Manual of Mental Disorders IV criteria insomnia'],['placebo'],"['PGI-S scores', 'measurement characteristics (validity, reliability, responsiveness and sensitivity', 'single-item Patient Global Impression-Severity (PGI-S) scale', 'insomnia severity', 'PGI-S responses', 'seven-item Insomnia Severity Index (ISI) and other subjective and objective assessments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0238851,"PGI-S scores decreased from baseline to Month 3 in a similar pattern to the ISI total score, and the Spearman correlation coefficient between PGI-S and the ISI was .73.","[{'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Snyder', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Peining', 'Initials': 'P', 'LastName': 'Tao', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Svetnik', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lines', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'W Joseph', 'Initials': 'WJ', 'LastName': 'Herring', 'Affiliation': 'Merck Research Laboratories, Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Journal of sleep research,['10.1111/jsr.13141']
2267,33210509,[Prevention of pancreatic fistula after pancreatoduodenectomy].,"OBJECTIVE


Prospective randomized investigation of the efficiency of somatostatin analogues and glucocorticoids in pancreatic fistula prevention after pancreatoduodenectomy by using.
MATERIAL AND METHODS


In period from December 2018 till March 2020 78 patients underwent pancreatoduodenectomy for pancreatobilliary tumors in department of abdominal surgery of National Medical Research Center of Surgery named after A.V. Vishnevsky. Intraoperative frozen section investigation of pancreatic functioning acinar structures (FAS) was held for all patients. 38 patients had more than 40% of FAC and were related with high risk of pancreatic fistula (PF), while 40 patients with less than 40% FAC were included in low risk of PF group. In both groups patients were randomized to main and control subgroups. In main subgroup of high risk group patients combination of somatostatin analogues and glucocorticoids was used, while in control subgroup patients received only somatostatin analogue. In low risk of PF group patients of main subgroup preventively got somatostatin analogue, while control group patients had no specific prophylaxis of PF. To assess the effect of drug prophylaxis on the development of pancreatic fistula we used logistic regression models with the inclusion of the drug use factor as an independent variable.
RESULTS


25 patients were included in main subgroup of high risk group. Clinically relevant pancreatic fistula (CRPF) developed in 14 (56%) cases. From 13 patients of control subgroup CRPF developed in 5 (38%) cases. In main subgroup of low risk group 18 patients were included and 3 (16%) of them had CRPF. In control subgroup were 22 patients and there were no cases of CRPF.
CONCLUSION


In our series combination of somatostatin analogue and glucocorticoid didn't show efficiency in prevention of CRPF in high risk patients, although difference between subgroups wasn't statistically significant ( p =0.34). In low risk group patients prophylactic use of somatostatin analogue also didn't show decline of CRPF incidence and the difference between subgroups also wasn't statistically significant ( p =0.46).",2020,In low risk group patients prophylactic use of somatostatin analogue also didn't show decline of CRPF incidence and the difference between subgroups also wasn't statistically significant ( p =0.46).,"['In period from December 2018 till March 2020 78 patients underwent pancreatoduodenectomy for pancreatobilliary tumors in department of abdominal surgery of National Medical Research Center of Surgery named after A.V. Vishnevsky', 'pancreatic fistula prevention after pancreatoduodenectomy by using', '25 patients were included in main subgroup of high risk group']","['somatostatin analogue', 'somatostatin analogue and glucocorticoid', 'pancreatoduodenectomy', 'somatostatin analogues and glucocorticoids']","['high risk of pancreatic fistula (PF', 'CRPF incidence', 'specific prophylaxis of PF', 'Clinically relevant pancreatic fistula (CRPF']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0732165', 'cui_str': 'Somatostatin analog'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]",25.0,0.088839,In low risk group patients prophylactic use of somatostatin analogue also didn't show decline of CRPF incidence and the difference between subgroups also wasn't statistically significant ( p =0.46).,"[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Kriger', 'Affiliation': 'National Medical Research Center of Surgery named after A.V. Vishnevsky of Ministry of health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Gorin', 'Affiliation': 'National Medical Research Center of Surgery named after A.V. Vishnevsky of Ministry of health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Kaldarov', 'Affiliation': 'National Medical Research Center of Surgery named after A.V. Vishnevsky of Ministry of health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Galkin', 'Affiliation': 'National Medical Research Center of Surgery named after A.V. Vishnevsky of Ministry of health of the Russian Federation, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202011161']
2268,33210524,Minimally invasive repair of ventral hernia with one third of tackers and fibrin glue: less pain and same recurrence rate.,"BACKGROUND


Aim of this study was to assess whether the reduction in the number of tackers maintains a similar recurrence rate and to subsequently evaluate whether this reduction associated with fibrin adhesive (FA) influences postsurgical pain after laparoscopic ventral hernia repair (LVHR) at 5 years follow-up.
METHODS


Fifty patients with ventral hernia (intervention group) underwent to LVHR with the double crown (DC) technique with a decrease in the number of tackers, each tacker being separated by about 3 cm associated with FA to seal the spaces between them. Data obtained from intervention group were compared to data obtained from a historical series of 50 patients (control group) undergoing LVHR using DC technique with tackers at 1 cm each other.
RESULTS


No statistically significant differences were found between groups about patients' characteristics. Mean hospital stay was 2 days. Statistically significant differences were observed about hospital stay between both groups U-Mann-Whitney ([UMW] =345, P=0) being higher in the control group. Statistically significant difference was observed in the postoperative pain evaluated by the visual analogical scale (VAS) score, having 95% of patients in the control group with VAS less than or equal to 7 compared to 4.55 in the intervention group. Recurrence rate was 4.1% for the control group versus 4.2% in the intervention group.
CONCLUSIONS


The reduction of metallic tackers associated with FA does not present statistically significant differences in the recurrence rate in comparison to conventional DC technique. In the intervention group a reduction in postoperative pain and hospital stay were observed.",2020,The reduction of metallic tackers associated with FA does not present statistically significant differences in the recurrence rate in comparison to conventional DC technique.,['Fifty patients with ventral hernia (intervention group) underwent to'],"['fibrin adhesive (FA', 'fibrin glue', 'laparoscopic ventral hernia repair (LVHR', 'LVHR with the double crown (DC) technique']","['hospital stay', 'postoperative pain and hospital stay', 'Mean hospital stay', 'Recurrence rate', 'reduction of metallic tackers', 'visual analogical scale (VAS) score', 'recurrence rate', 'pain and same recurrence rate', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.0602646,The reduction of metallic tackers associated with FA does not present statistically significant differences in the recurrence rate in comparison to conventional DC technique.,"[{'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Morales-Conde', 'Affiliation': 'Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, Virgen del Rocio University Hospital, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Balla', 'Affiliation': 'Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, Virgen del Rocio University Hospital, University of Sevilla, Sevilla, Spain - andrea.balla@gmail.com.'}, {'ForeName': 'Isaias', 'Initials': 'I', 'LastName': 'Alarcón', 'Affiliation': 'Unit of Innovation in Minimally Invasive Surgery, Department of General and Digestive Surgery, Virgen del Rocio University Hospital, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sánchez-Ramírez', 'Affiliation': 'Unit of General and Digestive Surgery, Quironsalud Sagrado Corazón Hospital, Sevilla, Spain.'}]",Minerva chirurgica,['10.23736/S0026-4733.20.08468-0']
2269,33210555,A field study investigating sensory manifestations in recreational female cyclists using a novel female-specific cycling pad.,"This randomized controlled field study aimed to design a female-specific cycling pad with reduced padding in the crotch area (half-pad) and test its effects on self-reported sensory manifestations in comparison with full-padded cycling bib shorts. Recreational female road cyclists (n = 183) participated (divided into two groups). Self-reported sensory manifestations were collected six times over 12 weeks. Sitting discomfort, wetness perception, thermal, texture sensation, and wear discomfort decreased over time for the crotch and sitting-bones areas in both groups. Irritation and tenderness in the crotch area also decreased over time in both groups. Irritation and tenderness in the sitting-bones area were only higher at week two in the half-pad compared with the full-pad group. Cycling with the half-padded shorts compared with the full-padded ones had no negative effects on sensory manifestations beside the observed transient change at week two. This suggests that foam thickness in the crotch area can be reduced in female-specific cycling pads.  Practitioner´s Summary:  Road cycling might result in discomfort and non-traumatic injuries in the female genital area. This field study compares two different cycling pads; a half-pad and a full-pad, over a 12-week period among female recreational road cyclists. Reducing the foam thickness in the crotch area of the pad does not change sensory manifestations, i.e., discomfort, wetness perception, texture-, and thermal-sensation as well as wear discomfort.",2020,Irritation and tenderness in the sitting-bones area were only higher at week two in the half-pad compared with the full-pad group.,"['female recreational road cyclists', 'Recreational female road cyclists (n\u2009=\u2009183) participated (divided into two groups', 'recreational female cyclists using a novel female-specific cycling pad']",[],"['Irritation and tenderness in the sitting-bones area', 'discomfort, wetness perception, texture-, and thermal-sensation as well as wear discomfort', 'Irritation and tenderness', 'Sitting discomfort, wetness perception, thermal, texture sensation, and wear discomfort decreased over time for the crotch and sitting-bones areas']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]",[],"[{'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",183.0,0.0210703,Irritation and tenderness in the sitting-bones area were only higher at week two in the half-pad compared with the full-pad group.,"[{'ForeName': 'Anna Sofie T', 'Initials': 'AST', 'LastName': 'Larsen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Kristoffer L', 'Initials': 'KL', 'LastName': 'Norheim', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ramtin Z', 'Initials': 'RZ', 'LastName': 'Marandi', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ernst A', 'Initials': 'EA', 'LastName': 'Hansen', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Madeleine', 'Affiliation': 'Sport Sciences - Performance and Technology, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}]",Ergonomics,['10.1080/00140139.2020.1853819']
2270,33202916,Point-of-Decision Prompts Increase Dietary Fiber Content of Consumers' Food Choices in an Online Grocery Shopping Simulation.,"Only 5% of Americans consume the recommended amount of dietary fiber. In an online simulated shopping experiment, we examined whether a fiber-focused point-of-decision prompt (PDP) would influence consumers to choose food products that were higher in this important nutrient. We hypothesized that participants exposed to the dietary fiber PDP would choose products with more dietary fiber/serving than those who were not exposed to the PDP. The experiment was completed by 753 participants. Participants were randomly assigned to a condition in which they were not exposed to a PDP (the no-PDP condition), a personalized PDP, or PDP without personalization. Choices in the two PDP conditions were not significantly different. Therefore, the PDP conditions were pooled together into one condition and compared with control participants that did not receive the fiber-focused PDP. Across the three product categories, participants in the PDP condition chose products that had a greater amount of dietary fiber/serving (cereal: 22% increase; bread: 22% increase; crackers: 26% increase;  p  < 0.01) and products that had a greater healthiness rating (cereals (odds ratio (OR): 1.45, 95% confidence interval (95% CI): (1.10, 1.92)), bread (OR: 1.44, 95% CI: (1.09, 1.91)), and crackers (OR: 1.66, 95% CI: (1.25, 2.21)). Overall, the fiber PDP influenced participants to choose healthier products that contained greater amounts of dietary fiber.",2020,Choices in the two PDP conditions were not significantly different.,['753 participants'],"['personalized PDP, or PDP without personalization', 'fiber-focused point-of-decision prompt (PDP']",[],[],"[{'cui': 'C0761024', 'cui_str': '5,10,15,20-tetrakis(2-N-methylpyridyl)porphyrinatopalladium(II)'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]",[],,0.0325048,Choices in the two PDP conditions were not significantly different.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Arslain', 'Affiliation': 'Department of Food Science and Technology, Institute of Agriculture and Natural Resources, University of Nebraska-Lincoln, Lincoln, NE 68588, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, Institute of Agriculture and Natural Resources, University of Nebraska-Lincoln, Lincoln, NE 68583, USA.'}, {'ForeName': 'Devin J', 'Initials': 'DJ', 'LastName': 'Rose', 'Affiliation': 'Department of Food Science and Technology, Institute of Agriculture and Natural Resources, University of Nebraska-Lincoln, Lincoln, NE 68588, USA.'}]",Nutrients,['10.3390/nu12113487']
2271,33202928,"A Randomized Controlled Trial Investigating the Effects of Equine Simulator Riding on Low Back Pain, Morphological Changes, and Trunk Musculature in Elderly Women.","Background and objectives:  Studies on the effects of an equine riding simulator (ERS) program on back pain, spinal alignment, and isokinetic moments in subjects with chronic low back pain (CLBP) remain limited. The purpose of this study was to analyze changes in elderly women with CLBP who participate in an ERS program.  Materials and Methods:  The 80 participants were all women aged 61-84 years who were randomly assigned to either the control group (CON) or ERS group (ERSG). ERS exercise was performed for a duration of 12 weeks (three times each week). The degree of pain was measured using the Oswestry Disability Index and the visual analog scale. Body composition and spinal alignment were measured using bioelectrical impedance and raster stereography. The isokinetic moments of trunk extensor and flexor were measured before and after the training period.  Results:  The ERSG showed a significant decrease in back pain compared to the CON. There was a significant decrease in levels of fat in the ERSG, although no differences were shown in terms of muscle mass. However, there was an increased basal metabolic rate (BMR) in the ERSG. Spinal alignment in the ERSG significantly improved. The peak torques of the trunk extensor in the ERSG were also significantly increased.  Conclusion:  It can be inferred that the ERS exercise can decrease fat and improve the trunk extensor strength through increased BMR, leading to better spinal alignment and reducing back pain in elderly women with CLBP.",2020,"There was a significant decrease in levels of fat in the ERSG, although no differences were shown in terms of muscle mass.","['subjects with chronic low back pain (CLBP', 'Elderly Women', 'elderly women with CLBP who participate in an ERS program', '80 participants were all women aged 61-84 years', 'elderly women with CLBP']","['Equine Simulator Riding', 'control group (CON) or ERS group (ERSG', 'ERS exercise', 'equine riding simulator (ERS) program']","['isokinetic moments of trunk extensor and flexor', 'Low Back Pain, Morphological Changes, and Trunk Musculature', 'levels of fat in the ERSG', 'Body composition and spinal alignment', 'Oswestry Disability Index and the visual analog scale', 'degree of pain', 'back pain', 'basal metabolic rate (BMR', 'peak torques of the trunk extensor in the ERSG', 'back pain, spinal alignment, and isokinetic moments']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",80.0,0.0316717,"There was a significant decrease in levels of fat in the ERSG, although no differences were shown in terms of muscle mass.","[{'ForeName': 'Sihwa', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Chang-Ju', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physiology, College of Medicine, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Yong-Seok', 'Initials': 'YS', 'LastName': 'Jee', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110610']
2272,33202996,Comparison of Learning Effects of Virtual Reality Simulation on Nursing Students Caring for Children with Asthma.,"With the global pandemic of the coronavirus disease, virtual reality simulation (vSim) has emerged as a simulation educational method. The purpose of this study is to examine the learning effects of vSim by comparing three different educational modalities of nursing care for children with asthma. A quasi-experimental design with three different teaching methods, vSim, high-fidelity simulation (HFS), and vSim with HFS, were used in the study. The group using vSim with HFS showed the highest scores in knowledge, confidence in practice, and performance compared to groups using vSim or HFS alone. Simulation practice using vSim combined with HFS could be an effective educational method for nursing students.",2020,"The group using vSim with HFS showed the highest scores in knowledge, confidence in practice, and performance compared to groups using vSim or HFS alone.","['nursing students', 'Nursing Students Caring for Children with Asthma', 'children with asthma']","['Virtual Reality Simulation', 'vSim combined with HFS', 'virtual reality simulation (vSim']","['highest scores in knowledge, confidence in practice, and performance']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.021205,"The group using vSim with HFS showed the highest scores in knowledge, confidence in practice, and performance compared to groups using vSim or HFS alone.","[{'ForeName': 'Kyung-Ah', 'Initials': 'KA', 'LastName': 'Kang', 'Affiliation': 'College of Nursing, Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'Shin-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'School of Nursing, Hallym University, Gangwon-do 25949, Korea.'}, {'ForeName': 'Myung-Nam', 'Initials': 'MN', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, College of Health Science, Kangwon National University Samcheok, Gangwon-do 25913, Korea.'}, {'ForeName': 'Mikang', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Laerdal Medical, Seoul 06725, Korea.'}, {'ForeName': 'Sunghee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul 06974, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17228417']
2273,33203003,Isoflavone Supplementation Does Not Potentiate the Effect of Combined Exercise Training on Resting and Ambulatory Blood Pressure in Non-Obese Postmenopausal Women: A Randomized Double-Blind Controlled Trial-A Pilot Study.,"Physical exercise and isoflavone supplementation are potential strategies to prevent and treat cardiovascular diseases in postmenopausal women. The aim of this study was to investigate whether there are additive effects of isoflavone supplementation when associated with combined aerobic and resistance exercise on resting and ambulatory blood pressure monitoring (ABPM) and in blood pressure variability (BPV). Thirty-one non-obese postmenopausal women were randomly allocated into two groups: placebo and exercise (Placebo  n  = 19); and isoflavone supplementation (100 mg/day) and exercise (isoflavone  n  = 19). ABPM and BPV were evaluated before and after 10 weeks of moderate combined (aerobic and resistance) exercise training. Generalized Estimating Equation (GEE) with Bonferroni correction and intention-to-treat analysis was used to compare the effects of interventions on resting BP, ABPM and BPV. Combined exercise training decreased resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time, with no additional effects of isoflavone supplementation. No changes were observed in sleep period, or in BPV indexes (Standard Deviation of 24 h (SD), daytime and nighttime interval (SDdn) and average real variability (ARV) in both groups. We conclude that isoflavone supplementation does not potentiate the effects of combined training on resting and ambulatorial systolic and diastolic blood pressure in non-obese postmenopausal women.",2020,"Combined exercise training decreased resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time, with no additional effects of isoflavone supplementation.","['non-obese postmenopausal women', 'Non-Obese Postmenopausal Women', 'Thirty-one non-obese postmenopausal women', 'postmenopausal women']","['isoflavone supplementation', 'Physical exercise and isoflavone supplementation', 'moderate combined (aerobic and resistance) exercise training', 'combined aerobic and resistance exercise', 'placebo and exercise (Placebo  n  = 19); and isoflavone supplementation (100 mg/day) and exercise (isoflavone  n  = 19', 'Combined exercise training', 'Isoflavone Supplementation', 'Combined Exercise Training']","['resting and ambulatory blood pressure monitoring (ABPM', 'sleep period, or in BPV indexes (Standard Deviation of 24 h (SD), daytime and nighttime interval (SDdn) and average real variability (ARV', 'blood pressure variability (BPV', 'resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time', 'resting and ambulatorial systolic and diastolic blood pressure', 'ABPM and BPV', 'Resting and Ambulatory Blood Pressure', 'resting BP, ABPM and BPV']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0006072', 'cui_str': 'Bovine papillomavirus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}]",,0.123019,"Combined exercise training decreased resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time, with no additional effects of isoflavone supplementation.","[{'ForeName': 'Juliene G C', 'Initials': 'JGC', 'LastName': 'Dechichi', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Igor M', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Jéssica S', 'Initials': 'JS', 'LastName': 'Giolo', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Jaqueline P', 'Initials': 'JP', 'LastName': 'Batista', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Paula A B', 'Initials': 'PAB', 'LastName': 'Ribeiro', 'Affiliation': 'Research Center of University of Montreal Hospital Centre, Montreal, QC H2X 0A9, Canada.'}, {'ForeName': 'Erick P', 'Initials': 'EP', 'LastName': 'de Oliveira', 'Affiliation': 'Laboratory of Nutrition, Exercise and Health (LaNES), School of Medicine, Federal University of Uberlandia (UFU), 38402-022 Uberlândia, MG, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}]",Nutrients,['10.3390/nu12113495']
2274,33203008,"Potato Fibers Have Positive Effects on Subjective Appetite Sensations in Healthy Men, but Not on Fecal Fat Excretion: A Randomized Controlled Single-Blind Crossover Trial.","Dietary fibers can affect appetite and gut metabolism, but the effect of the novel potato fibers FiberBind and rhamnogalacturonan I (RG-I) is unknown. We, therefore, aimed to investigate the effect of daily intake of FiberBind and RG-I on appetite sensations and fecal fat excretion. In a single-blinded, randomized, three-way crossover trial, wheat buns with FiberBind, RG-I, or low fiber (control) were consumed by 18 healthy men during a 21-day period. Appetite sensation and blood samples during a 3 h meal test, fecal fat content, and ad libitum energy intake were assessed after each period. Compared to RG-I and control, FiberBind caused a higher composite satiety score (6% ± 2% and 5% ± 2%), lower prospective food consumption (5% ± 2% and 6% ± 2%), and lower desire to eat (7% ± 3% and 6% ± 3%) (all  p  < 0.05). FiberBind also caused higher satiety (6% ± 2%) and fullness (9% ± 3%) compared to RG-I (all  p  < 0.01). No effects on fecal fat excretion or energy intake were found. The RG-I fiber caused higher postprandial glucose concentration compared to FiberBind ( p  < 0.05) and higher insulin concentration at 180 min compared to control ( p  < 0.05). Compared to the control, RG-I and FiberBind lowered peak insulin concentration (both  p  < 0.05) and delayed time to peak for glucose (both  p  < 0.05). In conclusion, FiberBind intake could be beneficial for appetite regulation, but neither FiberBind nor RG-I affected fecal fat excretion or energy intake.",2020,"Compared to the control, RG-I and FiberBind lowered peak insulin concentration (both  p  < 0.05) and delayed time to peak for glucose (both  p  < 0.05).","['Healthy Men', '18 healthy men during a 21-day period']","['FiberBind and RG-I', 'wheat buns with FiberBind, RG-I, or low fiber (control']","['lower prospective food consumption', 'higher satiety', 'Subjective Appetite Sensations', 'Fecal Fat Excretion', 'appetite sensations and fecal fat excretion', 'postprandial glucose concentration', 'delayed time to peak for glucose', 'Appetite sensation and blood samples', 'lower desire to eat', 'fullness', 'composite satiety score', 'higher insulin concentration', 'peak insulin concentration', 'fecal fat content, and ad libitum energy intake', 'fecal fat excretion or energy intake']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0073164', 'cui_str': 'rhamnogalacturonan I'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",18.0,0.0506501,"Compared to the control, RG-I and FiberBind lowered peak insulin concentration (both  p  < 0.05) and delayed time to peak for glucose (both  p  < 0.05).","[{'ForeName': 'Tanja Kongerslev', 'Initials': 'TK', 'LastName': 'Thorning', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Christel Johanneson', 'Initials': 'CJ', 'LastName': 'Bertolt', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Mette S', 'Initials': 'MS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}]",Nutrients,['10.3390/nu12113496']
2275,33203458,Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial.,"STUDY DESIGN


Pilot randomized controlled trial.
BACKGROUND


Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization.
METHODS


Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization.
RESULTS


Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants.
CONCLUSIONS


Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial.
TRIAL REGISTRATION


Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true.",2020,"METHODS


Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups.","['people with recent-onset neck pain at 48-h follow-up after randomization', 'Twenty adults with a new episode of mechanical neck pain', 'neck pain']","['cervical spine mobilization', 'single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist', 'https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true', 'pragmatic or prescriptive mobilization intervention']","['recruitment rates, randomization audit and completion of treatment and follow-up per protocol', 'disability level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.317113,"METHODS


Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lagoutaris', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Sullivan', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hancock', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Leaver', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia. andrew.leaver@sydney.edu.au.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00348-z']
2276,33203462,Case management after acquired brain injury compared to care as usual: study protocol for a 2-year pragmatic randomized controlled superiority trial with two parallel groups.,"BACKGROUND


People with acquired brain injury may suffer from cognitive, emotional and behavioural changes in the long term. Continuity of care is often lacking, leading to a variety of unmet needs and hindering psychosocial functioning from the occurrence of brain injury up to years thereafter. Case management aims to prevent (escalation of) problems and to facilitate timely access to appropriate services. In other populations, case management has shown to improve psychosocial well-being. In this study, we aim to evaluate the feasibility of case management after acquired brain injury and its effectiveness and cost-effectiveness, compared to care as usual.
METHODS


This is a pragmatic randomized controlled superiority trial with two parallel groups and repeated measures in adults with ABI and their family, taking place between November 2019 and December 2021 in three provinces in the Netherlands. Participants will be randomly allocated to either the case management group, receiving case management from hospital discharge up to 2 years thereafter, or the control group, receiving care as usual. Effectiveness will be evaluated every 6 months for 18-24 months by patient-reported psychosocial well-being (Hospital Anxiety and Depression Scale (HADS), Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) restriction subscale and the Life Satisfaction Questionnaire (LiSat)), self-management (Patient Activation Measure (PAM)) and care needs (Longer-term Unmet Needs after Stroke (LUNS)). Family outcomes include self-efficacy (Carer Self-Efficacy Scale (CSES)), caregiver burden (Caregiver Strain Index (CSI)), psychosocial well-being (LiSat, HADS), family needs (Family Needs Questionnaire (FNQ)). Feasibility will be evaluated using qualitative methods, assessing fidelity, dose delivered, dose received, reach, recruitment and context. Cost-effectiveness will be determined by the EQ-5D-3L and service use.
DISCUSSION


At the moment, there is no integrated health care service for people with acquired brain injury and their family members in the long term. If case management is shown to be feasible and (cost)-effective, it could bridge the gap between patients' and families' needs and the available services.
TRIAL REGISTRATION


Netherlands Trial Register NL8104 . Registered on 22 October 2019.",2020,"If case management is shown to be feasible and (cost)-effective, it could bridge the gap between patients' and families' needs and the available services.
","['adults with ABI and their family, taking place between November 2019 and December 2021 in three provinces in the Netherlands']","['case management group, receiving case management from hospital discharge up to 2\xa0years thereafter, or the control group, receiving care as usual']","['effectiveness and cost-effectiveness', 'psychosocial well-being (Hospital Anxiety and Depression Scale (HADS), Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) restriction subscale and the Life Satisfaction Questionnaire (LiSat)), self-management (Patient Activation Measure (PAM)) and care needs (Longer-term Unmet Needs after Stroke (LUNS', 'self-efficacy (Carer Self-Efficacy Scale (CSES)), caregiver burden (Caregiver Strain Index (CSI)), psychosocial well-being (LiSat, HADS), family needs (Family Needs Questionnaire (FNQ', 'Cost-effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0574453', 'cui_str': 'Lunda language'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",,0.123447,"If case management is shown to be feasible and (cost)-effective, it could bridge the gap between patients' and families' needs and the available services.
","[{'ForeName': 'Annemarie P M', 'Initials': 'APM', 'LastName': 'Stiekema', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School of Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Resch', 'Affiliation': 'Limburg Brain Injury Center, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Donkervoort', 'Affiliation': 'Health Care and Social Work Division, Windesheim University of Applied Sciences, Almere, The Netherlands.'}, {'ForeName': 'Natska', 'Initials': 'N', 'LastName': 'Jansen', 'Affiliation': 'Mevrouw Slimmer Werken Social Innovation in Health Care and Well-Being, Drogteropslagen, Netherlands.'}, {'ForeName': 'Kitty H M', 'Initials': 'KHM', 'LastName': 'Jurrius', 'Affiliation': 'Health Care and Social Work Division, Windesheim University of Applied Sciences, Almere, The Netherlands.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Zadoks', 'Affiliation': 'In-Tussen Foundation, Utrecht, the Netherlands.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'van Heugten', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School of Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands. c.vanheugten@maastrichtuniversity.nl.'}]",Trials,['10.1186/s13063-020-04804-2']
2277,33203471,Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial.,"BACKGROUND


Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for maternal mental health. As a consequence, mental illnesses are often overlooked and not treated adequately. If correctly diagnosed, cognitive behavioral therapy is currently the treatment of choice for mental illnesses. In addition, mindfulness-based interventions (MBIs) seem to represent a promising treatment option for anxiety and depression during the peripartum period. Considering the internet's increasing omnipresence, MBIs can also be offered electronically via a (tablet) computer or smartphone (electronically based MBI = eMBI).
OBJECTIVE


The current study aims to examine the clinical effectiveness and cost-effectiveness of an eMBI (the mindmom application) developed by an interdisciplinary team of gynecologists, psychologists, and midwives, teaching pregnant women how to deal with stress, pregnancy-related anxiety, and depressive symptoms. The study sample consists of pregnant women in their third trimester who screened positive for emotional distress. The mindmom study is a bicentric prospective randomized controlled trial (RCT), which is currently conducted at the University women's hospitals of Heidelberg and Tübingen, Germany.
METHODS


Within the scope of the routine prenatal care, pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany, are invited to participate in a screening for mental distress based on the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS screening result > 9 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony. After an initial psychological counseling, women are invited to participate in an eMBI in their last pregnancy trimester. The study will enroll N = 280 study participants (N = 140 per group), who are randomized 1:1 into the intervention (IG) or control group (treatment as usual = TAU). All participants are requested to complete a total of 7 digital assessments (5 visits pre- and 2 follow-up visits postpartum), involving self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles. The primary outcome will be depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire. Secondary outcomes include mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness.
DISCUSSION


This is the first German RCT to examine the (cost-)effectiveness of an eMBI on maternal mental health during pregnancy. If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome.
TRIAL REGISTRATION


Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00017210 . Registered on 13 January 2020. Retrospectively registered.",2020,"If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome.
","['pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany', ""University women's hospitals of Heidelberg and Tübingen, Germany"", 'enroll N\u2009=\u2009280 study participants (N\u2009=\u2009140 per group', 'maternal mental health during pregnancy', 'pregnant women in their third trimester who screened positive for emotional distress', 'Women with an EPDS screening result >\u20099 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony']","['intervention (IG) or control group (treatment as usual\u2009=\u2009TAU', 'electronic mindfulness-based intervention (eMBI', 'mindfulness-based interventions (MBIs', 'eMBI', 'cognitive behavioral therapy']","['Edinburgh Postnatal Depression Scale (EPDS', 'depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire', 'mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness', 'self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles', 'Effectiveness and cost-effectiveness', 'maternal mental health']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0430114', 'cui_str': 'Cortisol day curve'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",280.0,0.101383,"If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome.
","[{'ForeName': 'Mitho', 'Initials': 'M', 'LastName': 'Müller', 'Affiliation': 'Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Lina Maria', 'Initials': 'LM', 'LastName': 'Matthies', 'Affiliation': 'Universitätsklinikum Heidelberg Frauenklinik, Heidelberg, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Goetz', 'Affiliation': 'Universitätsklinikum Heidelberg Zentrum für Kinder und Jugendmedizin, Heidelberg, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Abele', 'Affiliation': 'Universitäts-Frauenklinik Tübingen, Tübingen, Germany.'}, {'ForeName': 'Sara Yvonne', 'Initials': 'SY', 'LastName': 'Brucker', 'Affiliation': 'Universitäts-Frauenklinik Tübingen, Tübingen, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Bauer', 'Affiliation': ""Institute for Women's Health Tübingen, Tübingen, Germany.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Graf', 'Affiliation': 'Universitätsklinikum Tübingen Medizinische Universitätsklinik, Tübingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Universitätsklinikum Tübingen Medizinische Universitätsklinik, Tübingen, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hasemann', 'Affiliation': 'Universität Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wallwiener', 'Affiliation': 'Universitätsklinikum Heidelberg Frauenklinik, Heidelberg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wallwiener', 'Affiliation': 'Universitätsklinikum Heidelberg Frauenklinik, Heidelberg, Germany. stephanie.wallwiener@googlemail.com.'}]",Trials,['10.1186/s13063-020-04873-3']
2278,33203476,Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['severely ill adults with COVID-19'],['human anti-SARS-CoV-2 convalescent plasma'],['efficacy and safety'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0823071,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod Jessica Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04877-z']
2279,33203618,Randomized evaluation of beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT): Rationale and design.,"Myocardial infarction with non-obstructive coronary arteries (MINOCA) is common and occurs in 6-8% of all patients fulfilling the diagnostic criteria for acute myocardial infarction (AMI). This paper describes the rationale behind the trial 'Randomized Evaluation of Beta Blocker and ACE-Inhibitor/Angiotensin Receptor Blocker Treatment (ACEI/ARB) of MINOCA patients' (MINOCA-BAT) and the need to improve the secondary preventive treatment of MINOCA patients. METHODS: MINOCA-BAT is a registry-based, randomized, parallel, open-label, multicenter trial with 2:2 factorial design. The primary aim is to determine whether oral beta blockade compared with no oral beta blockade, and ACEI/ARB compared with no ACEI/ARB, reduce the composite endpoint of death of any cause, readmission because of AMI, ischemic stroke or heart failure in patients discharged after MINOCA without clinical signs of heart failure and with left ventricular ejection fraction ≥40%. A total of 3500 patients will be randomized into four groups; e.g. ACEI/ARB and beta blocker, beta blocker only, ACEI/ARB only and neither ACEI/ARB nor beta blocker, and followed for a mean of 4 years. SUMMARY: While patients with MINOCA have an increased risk of serious cardiovascular events and death, whether conventional secondary preventive therapies are beneficial has not been assessed in randomized trials. There is a limited basis for guideline recommendations in MINOCA. Furthermore, studies of routine clinical practice suggest that use of secondary prevention therapies in MINOCA varies considerably. Thus results from this trial may influence future treatment strategies and guidelines specific to MINOCA patients.",2020,"While patients with MINOCA have an increased risk of serious cardiovascular events and death, whether conventional secondary preventive therapies are beneficial has not been assessed in randomized trials.","['3500 patients', 'patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT', 'patients discharged after MINOCA without clinical signs of heart failure and with left ventricular ejection fraction ≥40']","['ACEI/ARB and beta blocker, beta blocker only, ACEI/ARB only and neither ACEI/ARB nor beta blocker', 'Beta Blocker and ACE-Inhibitor/Angiotensin Receptor Blocker Treatment (ACEI/ARB', 'oral beta blockade', 'no oral beta blockade, and ACEI/ARB', 'beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment']","['Myocardial infarction', 'risk of serious cardiovascular events and death', 'composite endpoint of death of any cause, readmission because of AMI, ischemic stroke or heart failure']","[{'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205304', 'cui_str': 'Non-obstructive'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",3500.0,0.0904556,"While patients with MINOCA have an increased risk of serious cardiovascular events and death, whether conventional secondary preventive therapies are beneficial has not been assessed in randomized trials.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Nordenskjöld', 'Affiliation': 'Department of Cardiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. Electronic address: anna.nordenskjold@regionorebrolan.se.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Agewall', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Norway, and Institute of Clinical Sciences, University of Oslo, Norway.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Atar', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Norway, and Institute of Clinical Sciences, University of Oslo, Norway.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Baron', 'Affiliation': 'Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Beltrame', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Basil Hetzel Institute, Central Adelaide Local Health Network, Adelaide, Australia.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Bergström', 'Affiliation': 'Department of Medicine/Cardiology, County Hospital of Kronoberg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Chris P', 'Initials': 'CP', 'LastName': 'Gale', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'López-Pais', 'Affiliation': 'Department of Cardiology, University Hospital Complex of Santiago de Compostela, Spain.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jernberg', 'Affiliation': 'Department of clinical sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pelle', 'Initials': 'P', 'LastName': 'Johansson', 'Affiliation': 'Senior research manager, The Swedish Heart and Lung Association, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Ravn-Fisher', 'Affiliation': 'Department of Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""Sarah Ross Soter Center for Women's Cardiovascular Research, Leon H. Charney Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York.""}, {'ForeName': 'Jithendra B', 'Initials': 'JB', 'LastName': 'Somaratne', 'Affiliation': 'Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Tornvall', 'Affiliation': 'Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Lindahl', 'Affiliation': 'Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}]",American heart journal,['10.1016/j.ahj.2020.10.059']
2280,33203621,"Feasibility, Acceptability and Effectiveness of Enhanced Cognitive Behavioral Therapy (eCBT) for Children and Adolescents With Obsessive-Compulsive Disorder: Therapeutic Intervention and Trial Protocol.","BACKGROUND


Although the evidence-base of cognitive behavioral therapy (CBT) for pediatric obsessive-compulsive disorder (OCD) has been broadly established, the treatment is hampered by limited access, poor compliance and non-response. New technologies offer the opportunity to improve accessibility, user friendliness, and effectiveness of traditional office-based CBT. By employing an integrated and age appropriate technological enhanced treatment package, we aim to execute a more focused and attractive application of CBT principles to increase treatment effect for pediatric OCD.
OBJECTIVE


The aim of this open study is to explore acceptability, feasibility and effectiveness of a newly developed enhanced CBT (eCBT) package for pediatric OCD.
METHODS


The present study is an open trial using a historical control design, conducted at the outpatient clinic of the department of child and adolescent psychiatry at St Olav's University Hospital (Trondheim), or at BUP Klinikk (Aalesund). Participants are 30 children (7-17 years) with a primary DSM-5 diagnosis of OCD, and their parents. All participants receive eCBT. eCBT consists of the usual, evidence-based CBT for pediatric OCD in an 'enhanced' format. Enhancements include videoconferencing sessions (supervision and guided exposure exercises at home) in addition to face-to-face sessions; an app system of interconnected apps for the child, the parents and the therapist; psychoeducative videos; and frequent online self-assessments with direct feedback to patients and the therapist. Primary outcome measures are the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (effectiveness), the Client Satisfaction Questionnaire-8 (acceptability), and treatment drop-out (feasibility). Assessments are conducted pre-treatment, post-treatment and at 3- and 6-months follow-up. A 12-month follow-up assessment is envisioned. Treatment outcome (CY-BOCS) will be compared to traditional face-to-face CBT (data collected in the Nordic Long-term OCD Treatment Study).
RESULTS


Ethical approval has been obtained (reference ""2016/716/REK nord""). Inclusion has started on 04-09-2017. Data collection is ongoing.
CONCLUSIONS


The present study is a first step in testing the acceptability, feasibility, and preliminary effectiveness of eCBT. In case of positive results, future steps include improvement of the eCBT treatment package based on feedback from service users, to examine (cost-)effectiveness in a randomized controlled trial, and making the package available for clinicians and other service providers treating OCD in children and adolescents.
CLINICALTRIAL


ISRCTN, ISRCTN37530113. Registered 31 January 2020 (retrospectively registered), https://www.isrctn.com/ISRCTN37530113.",2020,Primary outcome measures are the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS),"['Registered 31 January 2020 (retrospectively registered), https://www.isrctn.com/ISRCTN37530113', 'Children and Adolescents With Obsessive-Compulsive Disorder', 'children and adolescents', 'pediatric obsessive-compulsive disorder (OCD', 'Participants are 30 children (7-17 years) with a primary DSM-5 diagnosis of OCD, and their parents', ""outpatient clinic of the department of child and adolescent psychiatry at St Olav's University Hospital (Trondheim), or at BUP Klinikk (Aalesund""]","['videoconferencing sessions (supervision and guided exposure exercises at home', 'cognitive behavioral therapy (CBT', 'enhanced CBT (eCBT) package', 'Enhanced Cognitive Behavioral Therapy (eCBT', 'eCBT']","['Feasibility, Acceptability and Effectiveness', ""Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS"", 'acceptability, feasibility and effectiveness', 'Client Satisfaction Questionnaire-8 (acceptability), and treatment drop-out (feasibility']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001583', 'cui_str': 'Adolescent Psychiatry'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]",,0.0305467,Primary outcome measures are the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS),"[{'ForeName': 'Lidewij H', 'Initials': 'LH', 'LastName': 'Wolters', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU Central Norway), Department of Mental Health, Norwegian University of Science and Technology (NTNU), Klostergata 46, Trondheim, NO.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weidle', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU Central Norway), Department of Mental Health, Norwegian University of Science and Technology (NTNU), Klostergata 46, Trondheim, NO.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Babiano-Espinosa', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU Central Norway), Department of Mental Health, Norwegian University of Science and Technology (NTNU), Klostergata 46, Trondheim, NO.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Skokauskas', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare (RKBU Central Norway), Department of Mental Health, Norwegian University of Science and Technology (NTNU), Klostergata 46, Trondheim, NO.'}]",JMIR research protocols,['10.2196/24057']
2281,33203625,"Efficacy of quadruple regimen with polaprezinc for gastric  Helicobacter pylori  infection eradication: protocol for a single-centre, single-blind, non-inferiority, randomised clinical trial.","INTRODUCTION


Helicobacter pylori (H. pylori)  is the most well-known risk factor for gastric cancer. At present,  H. pylori  shows varying levels of resistance to different treatments, leading to a lower rate of  H. pylori  eradication. The aim of this study is to evaluate the efficacy of polaprezinc-containing quadruple therapy (PQT) for the eradication of  H. pylori  infection and, thus, to provide more evidence to inform the clinical treatment of  H. pylori  infection in China.
METHODS AND ANALYSIS


This is a single-centre, single-blind, non-inferiority, randomised controlled trial, enrolling 158 patients with  H. pylori  infection. Patients are randomised (1:1) to the two groups for a 14-day therapy. Treatment group: PQT (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, polaprezinc 75 mg) two times per day; control group: bismuth-containing quadruple therapy (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bismuth potassium citrate 220 mg) two times per day. The primary outcome is the rate of  H. pylori  eradication. Secondary outcomes are the incidence of adverse events and the gastrointestinal microbiota distribution. The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.
ETHICS AND DISSEMINATION


This study was approved by the Ethics Committee of Sichuan Cancer Center & Hospital (No. SCCHEC-02-2019-015). Any amendment to the research protocol will be submitted for ethical approval. All participants must provide informed consent. On completion, the results of the study will be published in the appropriate peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ChiCTR1900025800; preresults.",2020,"The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.
","['Sichuan Cancer Center & Hospital', '158 patients with  H. pylori  infection']","['PQT (esomeprazole 20\u2009mg, amoxicillin 1\u2009g, clarithromycin 500\u2009mg, polaprezinc 75\u2009mg) two times per day; control group: bismuth-containing quadruple therapy (esomeprazole 20\u2009mg, amoxicillin 1\u2009g, clarithromycin 500\u2009mg, bismuth potassium citrate', 'polaprezinc-containing quadruple therapy (PQT', 'polaprezinc']","['incidence of adverse events and the gastrointestinal microbiota distribution', 'rate of  H. pylori  eradication']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0286382', 'cui_str': 'polaprezinc'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbiota'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",158.0,0.0947054,"The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.
","[{'ForeName': 'Dingkun', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, Jilin People's Hospital, Jilin, China.""}, {'ForeName': 'Tingyuan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Qinwen', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'West China School of Public Health/West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China gw_zhaoyuqian@126.com chenwen@cicams.ac.cn.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China gw_zhaoyuqian@126.com chenwen@cicams.ac.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037182']
2282,33203626,"Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study.","INTRODUCTION


The number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure.
METHODS AND ANALYSIS


The study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04127383).",2020,"The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care.","['patients with COPD, asthma, diabetes mellitus type 2 and heart failure', 'people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure']","['ABCC tool', 'ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care']","[""change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs"", 'Effectiveness and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0779535,"The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care.","[{'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Boudewijns', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands esther.boudewijns@maastrichtuniversity.nl.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Claessens', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Joore', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lotte C E M', 'Initials': 'LCEM', 'LastName': 'Keijsers', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Onno C P', 'Initials': 'OCP', 'LastName': 'van Schayck', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Annerika H M', 'Initials': 'AHM', 'LastName': 'Gidding-Slok', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-037693']
2283,33203854,Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07).,"In this multicenter, open-label, randomized phase II investigator-sponsored neoadjuvant trial with funding provided by Sanofi and GlaxoSmithKline (TRIO-US B07, Clinical Trials NCT00769470), participants with early-stage HER2-positive breast cancer (N = 128) were recruited from 13 United States oncology centers throughout the Translational Research in Oncology network. Participants were randomized to receive trastuzumab (T; N = 34), lapatinib (L; N = 36), or both (TL; N = 58) as HER2-targeted therapy, with each participant given one cycle of this designated anti-HER2 therapy alone followed by six cycles of standard combination chemotherapy with the same anti-HER2 therapy. The primary objective was to estimate the rate of pathologic complete response (pCR) at the time of surgery in each of the three arms. In the intent-to-treat population, we observed similar pCR rates between T (47%, 95% confidence interval [CI] 30-65%) and TL (52%, 95% CI 38-65%), and a lower pCR rate with L (25%, 95% CI 13-43%). In the T arm, 100% of participants completed all protocol-specified treatment prior to surgery, as compared to 69% in the L arm and 74% in the TL arm. Tumor or tumor bed tissue was collected whenever possible pre-treatment (N = 110), after one cycle of HER2-targeted therapy alone (N = 89), and at time of surgery (N = 59). Higher-level amplification of HER2 and hormone receptor (HR)-negative status were associated with a higher pCR rate. Large shifts in the tumor, immune, and stromal gene expression occurred after one cycle of HER2-targeted therapy. In contrast to pCR rates, the L-containing arms exhibited greater proliferation reduction than T at this timepoint. Immune expression signatures increased in all arms after one cycle of HER2-targeted therapy, decreasing again by the time of surgery. Our results inform approaches to early assessment of sensitivity to anti-HER2 therapy and shed light on the role of the immune microenvironment in response to HER2-targeted agents.",2020,Higher-level amplification of HER2 and hormone receptor (HR)-negative status were associated with a higher pCR rate.,['participants with early-stage HER2-positive breast cancer (N\u2009=\u2009128) were recruited from 13 United States oncology centers throughout the Translational Research in Oncology network'],"['trastuzumab', 'lapatinib (L; N\u2009=\u200936), or both (TL; N\u2009=\u200958) as HER2-targeted therapy, with each participant given one cycle of this designated anti-HER2 therapy alone followed by six cycles of standard combination chemotherapy with the same anti-HER2 therapy', 'Sanofi and GlaxoSmithKline', 'neoadjuvant trastuzumab and/or lapatinib']","['proliferation reduction', 'Tumor or tumor bed tissue', 'Immune expression signatures', 'pCR rates', 'rate of pathologic complete response (pCR', 'TL']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3494163', 'cui_str': 'Translational Research'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",128.0,0.0522356,Higher-level amplification of HER2 and hormone receptor (HR)-negative status were associated with a higher pCR rate.,"[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA. SHurvitz@mednet.ucla.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Caswell-Jin', 'Affiliation': 'Department of Medicine, Division of Oncology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'McNamara', 'Affiliation': 'Department of Medicine, Division of Oncology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Zoeller', 'Affiliation': 'Department of Cell Biology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Bean', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dichmann', 'Affiliation': 'Central Coast Medical Oncology, Santa Maria, CA, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ravindranath', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Comprehensive Blood & Cancer Center, Bakersfield, CA, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Zehngebot', 'Affiliation': 'Florida Cancer Specialists & Research Institute, Orlando, FL, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Allen', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bosserman', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'DiCarlo', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'FCPP Hematology/Oncology, San Luis Obispo, CA, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Giuliano', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Calfa', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Molthrop', 'Affiliation': 'Florida Cancer Specialists & Research Institute, Orlando, FL, USA.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Mani', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Hsiao-Wang', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Dering', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Adams', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Kotler', 'Affiliation': 'Department of Medicine, Division of Oncology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Press', 'Affiliation': 'Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Joan S', 'Initials': 'JS', 'LastName': 'Brugge', 'Affiliation': 'Department of Cell Biology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Curtis', 'Affiliation': 'Department of Medicine, Division of Oncology, Stanford University School of Medicine, Stanford, CA, USA. cncurtis@stanford.edu.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Slamon', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}]",Nature communications,['10.1038/s41467-020-19494-2']
2284,33203954,"Phase 1 randomized study on the safety, tolerability, and pharmacodynamic cognitive and electrophysiological effects of a dopamine D 1  receptor positive allosteric modulator in patients with schizophrenia.","ASP4345, a novel dopamine D 1  receptor positive allosteric modulator, is being evaluated for the treatment of cognitive impairment associated with schizophrenia (CIAS). This phase 1 multiple ascending-dose study (NCT02720263) assessed the safety, tolerability, and pharmacodynamics of ASP4345 in patients with schizophrenia/schizoaffective disorder. Pharmacodynamic assessments were Cogstate cognitive tests and electrophysiological biomarkers, including gamma-band power and phase synchronization in response to 40-Hz auditory steady-state stimulation, as well as mismatch negativity (MMN) and P3a event-related potentials. The sample size determination was based on standard practice in assessing safety and tolerability of a new chemical entity. Data were summarized by conversion of this data into effect sizes using descriptive and inferential statistics. A total of 36 randomized patients received ASP4345 (3, 15, 50, and 150 mg; n = 9 each dose) and 12 patients received placebo. Patients in the ASP4345 group experienced 73 treatment-emergent adverse events (TEAEs) and 34 TEAEs were reported for the placebo group. The most common TEAEs were headache and somnolence and nearly all TEAEs were mild in severity. No changes in mood or self-reports of suicidal ideation/behavior were observed. Improvements in performance on cognitive tests were noted, which suggests a potential improvement in psychomotor function and visual attention. Furthermore, positive changes in neurophysiological biomarkers (auditory steady-state response [ASSR] and MMN) suggest improvement in information processing. The findings need to be confirmed in studies with a larger patient population. Nonetheless, the trends in safety and pharmacodynamic data support further clinical development of ASP4345 for the treatment of CIAS.",2020,"Pharmacodynamic assessments were Cogstate cognitive tests and electrophysiological biomarkers, including gamma-band power and phase synchronization in response to 40-Hz auditory steady-state stimulation, as well as mismatch negativity (MMN) and P3a event-related potentials.","['patients with schizophrenia', 'patients with schizophrenia/schizoaffective disorder']","['placebo', 'dopamine D', 'ASP4345']","['mood or self-reports of suicidal ideation/behavior', 'psychomotor function and visual attention', 'safety, tolerability, and pharmacodynamic cognitive and electrophysiological effects', 'neurophysiological biomarkers (auditory steady-state response [ASSR] and MMN', '73 treatment-emergent adverse events (TEAEs', 'safety, tolerability, and pharmacodynamics', 'headache and somnolence', 'Cogstate cognitive tests and electrophysiological biomarkers, including gamma-band power and phase synchronization in response to 40-Hz auditory steady-state stimulation, as well as mismatch negativity (MMN) and P3a event-related potentials']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1720831', 'cui_str': 'P3a Event-Related Potentials'}]",36.0,0.0657006,"Pharmacodynamic assessments were Cogstate cognitive tests and electrophysiological biomarkers, including gamma-band power and phase synchronization in response to 40-Hz auditory steady-state stimulation, as well as mismatch negativity (MMN) and P3a event-related potentials.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA. amit.desai@astellas.com.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Benner', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Ruishan', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Gertsik', 'Affiliation': 'California Clinical Trials Medical Group, Inc., Glendale, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Maruff', 'Affiliation': 'Cogstate, Inc., Melbourne, VIC, Australia.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Uz', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Marek', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Astellas Pharma Global Development, Inc., Northbrook, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00908-0']
2285,33203966,Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey.,"OBJECTIVE


The aim of the study was to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving consent process in child for biospecimen donation.
METHODS


A multi-center randomized and controlled survey was performed at two pediatric hospitals in China from 2019 to 2020. Children aged from 7 to 18 years in the pediatric surgery wards were invited to investigate the participants' willingness and attitudes for donating biospecimens. A total of 264 children, including 119 in the AACQ group and 145 in the TQ group, and 67 parents of children were analyzed. A separate knowledge test was acquired in the questionnaires.
RESULTS


Our findings showed that the response rate of the AACQ group (89.85%) was significantly higher than that of the TQ group (68.44%; p < 0.001). AACQ can improve the child's understanding, increase children's engagement in biospecimen donation, reduced the differences in selected characteristics affecting children understanding, and enhanced their risk awareness of donating biospecimens. We also found that increasing pain and privacy disclosure were the most popular concern among children for the refusal to donate biospecimens.
CONCLUSIONS


AACQ is an effective and standardized tool of content delivery to children from the surgical wards. Children who fully understood of biospecimen donation are suggested to participate in the consent signing.
IMPACT


Using audio and animated cartoon questionnaire is a more effective and standardized tool of content delivery to children. This study expanded the use of an animated cartoon to a children's survey. Audio and animated cartoon questionnaire (AACQ) can improve the child's understanding, increase children's engagement in biospecimen donation compared to text questionnaire (TQ) group, and enhanced their risk awareness of donating biospecimens. More AACQ should be used with children in the future to effectively deliver content to children and improve children's participation in the survey.",2020,Our findings showed that the response rate of the AACQ group (89.85%) was significantly higher than that of the TQ group (68.44%; p < 0.001).,"['A multi-center randomized and controlled survey was performed at two pediatric hospitals in China from 2019 to 2020', '264 children, including 119 in the AACQ group and 145 in the TQ group, and 67 parents of children were analyzed', 'child for biospecimen donation', ""Children aged from 7 to 18 years in the pediatric surgery wards were invited to investigate the participants' willingness and attitudes for donating biospecimens"", 'children']","['text questionnaire (TQ', 'IMPACT\n\n\nUsing audio and animated cartoon questionnaire', 'AACQ', 'TQ', 'audio and animated cartoon questionnaire (AACQ', 'Audio and animated cartoon questionnaire (AACQ', 'cartoon questionnaire', 'animated cartoon']","['response rate', 'pain and privacy disclosure']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007306', 'cui_str': 'Cartoons'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0007306', 'cui_str': 'Cartoons'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]",264.0,0.0348282,Our findings showed that the response rate of the AACQ group (89.85%) was significantly higher than that of the TQ group (68.44%; p < 0.001).,"[{'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Qiu', 'Affiliation': ""Department of Pediatric Neurosurgery, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""Department of Pediatric Neurosurgery, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': ""Department of Pediatric Urinary Surgery, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Pediatric Urinary Surgery, Henan Children's Hospital Affiliated to Zhengzhou University, Henan, China.""}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ""Department of Clinical Laboratory, the Sixth People's Hospital Of Zhengzhou, Henan, China.""}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatric General Surgery, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Department of Data Science, School of Population Health, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Developmental and Behavioral Pediatrics, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bao', 'Affiliation': ""Department of Pediatric Neurosurgery, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shijian', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Pediatric Health Advocacy Institute, Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine, Shanghai, China. liushijian@scmc.com.cn.""}]",Pediatric research,['10.1038/s41390-020-01227-2']
2286,33204004,Post-hoc analysis of a randomized controlled trial on the impact of pre-transplant use of probiotics on outcomes after liver transplantation.,"Perioperative use of probiotics serves as efficient prophylaxis against postoperative infections after liver transplantation, yet data on long-term effects of pre-transplant probiotic intake is lacking. The aim of this study was to assess the effects of pre-transplant probiotic administration on long-term results of liver transplantation. This was secondary analysis of a randomized trial. Patients were randomized to receive either 4-strain probiotic or placebo before liver transplantation. Five year graft survival was set as the primary end-point. Secondary end-points comprised serum bilirubin and C-reactive protein (CRP) concentration, international normalized ratio (INR), serum transaminases and gamma-glutamyl transferase (GGT) activity. Study group comprised 44 patients, of whom 21 received probiotics and 23 received placebo with 5-year graft survival of 81.0% and 87.0%, respectively (p = 0.591). Patients in the probiotic arm exhibited lower INR (p = 0.001) and CRP (p = 0.030) over the first 6 post-transplant months. In the absence of hepatitis B or C virus infection, pre-transplant administration of probiotics also reduced aspartate transaminase activity (p = 0.032). In the intervention arm, patients receiving probiotics for under and over 30 days had 5-year graft survival rates of 100% and 66.7%, respectively (p = 0.061). Duration of probiotic intake > 30 days was additionally associated with increased INR (p = 0.031), GGT (p = 0.032) and a tendency towards increased bilirubin (p = 0.074) over first 6 post-transplant months. Pre-transplant administration of probiotics has mild positive influence on 6-month allograft function, yet should not exceed 30 days due to potential negative effects on long-term outcomes. (ClinicalTrials.gov Identifier: NCT01735591).",2020,Patients in the probiotic arm exhibited lower INR (p = 0.001) and CRP (p = 0.030) over the first 6 post-transplant months.,['liver transplantation'],"['placebo', '4-strain probiotic or placebo', 'probiotic intake\u2009', 'pre-transplant probiotic administration']","['aspartate transaminase activity', 'bilirubin', 'serum bilirubin and C-reactive protein (CRP) concentration, international normalized ratio (INR), serum transaminases and gamma-glutamyl transferase (GGT) activity', 'CRP', 'INR', '5-year graft survival rates', 'increased INR', 'Five year graft survival', '5-year graft survival']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0428441', 'cui_str': 'Serum bilirubin measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.211539,Patients in the probiotic arm exhibited lower INR (p = 0.001) and CRP (p = 0.030) over the first 6 post-transplant months.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Grąt', 'Affiliation': 'Second Department of Clinical Radiology, Medical University of Warsaw, Banacha 1A, 02-097, Warsaw, Poland. karolina.grat@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Krawczyk', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Lewandowski', 'Affiliation': 'Department of Epidemiology and Biostatistics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Krasnodębski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Ł', 'Initials': 'Ł', 'LastName': 'Masior', 'Affiliation': 'Second Department of General, Vascular and Oncological Surgery, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.'}]",Scientific reports,['10.1038/s41598-020-76994-3']
2287,33211022,Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial.,"BACKGROUND


With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission.
OBJECTIVE


The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions.
METHODS


The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans.
RESULTS


The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked.
CONCLUSIONS


This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/20904.",2020,"MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans.
",['Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention'],"['MDA with IVM plus DP', 'Malaria Control Interventions', 'Mass drug administration (MDA) of artemisinin-based combination therapy (ACT', 'IVM plus DP', 'Ivermectin and Dihydroartemisinin-Piperaquine', 'MDA with IVM plus dihydroartemisinin-piperaquine (DP', 'standard malaria interventions']",['vector survival'],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0016993', 'cui_str': 'The Gambia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.154446,"MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans.
","[{'ForeName': 'Edgard Diniba', 'Initials': 'ED', 'LastName': 'Dabira', 'Affiliation': 'Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, Banjul, Gambia.'}, {'ForeName': 'Harouna M', 'Initials': 'HM', 'LastName': 'Soumare', 'Affiliation': 'Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, Banjul, Gambia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lindsay', 'Affiliation': 'Department of Biosciences, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Bakary', 'Initials': 'B', 'LastName': 'Conteh', 'Affiliation': 'Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, Banjul, Gambia.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ceesay', 'Affiliation': 'Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, Banjul, Gambia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kositz', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Broekhuizen', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Balla', 'Initials': 'B', 'LastName': 'Kandeh', 'Affiliation': 'National Malaria Control Program, The Gambia, Banjul, Gambia.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Fehr', 'Affiliation': 'Medical Anthropology Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nieto-Sanchez', 'Affiliation': 'Medical Anthropology Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Joan Muela', 'Initials': 'JM', 'LastName': 'Ribera', 'Affiliation': 'Medial Anthropology Research Center, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Peeters Grietens', 'Affiliation': 'Medical Anthropology Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Menno Roderick', 'Initials': 'MR', 'LastName': 'Smit', 'Affiliation': ""Amsterdam Centre for Global Child Health, Emma Children's Hospital, Amsterdam University Medical Centres, Amsterdam, The Netherlands, Amsterdam, Netherlands.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Drakeley', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Achan', 'Affiliation': 'Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, Banjul, Gambia.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, Banjul, Gambia.'}]",JMIR research protocols,['10.2196/20904']
2288,33211076,Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.,"Importance


Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment.
Objective


To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab.
Design, Setting, and Participants


This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis.
Interventions


Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48.
Main Outcomes and Measures


Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of -3 letters to 3 letters for BCVA and -36 μm to 36 μm for CST.
Results


Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of -0.8 letter (90% CI, -1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were -108 (5) μm in the SB11 group vs -100 (5) μm in the ranibizumab group, with an adjusted treatment difference of -8 μm (95% CI, -19 to 3 μm). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group.
Conclusions and Relevance


These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration.
Trial Registration


ClinicalTrials.gov Identifier: NCT03150589.",2020,"Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups.","['patients with neovascular age-related macular degeneration', 'individuals 50 years or older', '705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years', '75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions', 'Patients With Neovascular Age-Related Macular Degeneration']","['SB11 or ranibizumab', 'Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product', 'ranibizumab', 'ranibizumab biosimilar product (SB11', 'SB11']","['serious treatment-emergent adverse events', 'Efficacy and Safety', 'Least-squares mean (SE) changes in BCVA', 'Immunogenicity', 'Incidences of treatment-emergent adverse events', 'best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST', 'cumulative incidence of antidrug antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",705.0,0.40346,"Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups.","[{'ForeName': 'Se Joon', 'Initials': 'SJ', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Veith', 'Affiliation': 'Department of Ophthalmology, Third Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hamouz', 'Affiliation': 'Department of Ophthalmology, Third Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ernest', 'Affiliation': 'Department of Ophthalmology, Central Military Hospital, Prague, Czech Republic.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Zalewski', 'Affiliation': 'Diagnostic and Microsurgery Center of the Eye LENS, Olsztyn, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Studnicka', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine in Hradec Kralove, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Vajas', 'Affiliation': 'Department of Ophthalmology, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Andras', 'Initials': 'A', 'LastName': 'Papp', 'Affiliation': 'Department of Ophthalmology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Vogt', 'Initials': 'V', 'LastName': 'Gabor', 'Affiliation': 'Department of Ophthalmology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Luu', 'Affiliation': 'Retina Consultants of Southern Colorado, Colorado Springs.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Matuskova', 'Affiliation': 'Department of Ophthalmology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Pregun', 'Affiliation': 'Department of Ophthalmology, Bajcsy-Zsilinszky Hospital, Budapest, Hungary.'}, {'ForeName': 'Taehyung', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Medical Team, Samsung Bioepis, Incheon, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Medical Team, Samsung Bioepis, Incheon, Korea.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.5053']
2289,33211153,Intermittent post-exercise sauna bathing improves markers of exercise capacity in hot and temperate conditions in trained middle-distance runners.,"PURPOSE


This study investigated whether intermittent post-exercise sauna bathing across three-weeks endurance training improves exercise heat tolerance and exercise performance markers in temperate conditions, compared to endurance training alone. The subsidiary aim was to determine whether exercise-heat tolerance would further improve following 7-Weeks post-exercise sauna bathing.
METHODS


Twenty middle-distance runners (13 female; mean ± SD, age 20 ± 2 years, [Formula: see text]O 2max  56.1 ± 8.7 ml kg -1  min -1 ) performed a running heat tolerance test (30-min, 9 km h -1 /2% gradient, 40 °C/40%RH; HTT) and temperate (18 °C) exercise tests (maximal aerobic capacity [[Formula: see text]O 2max ], speed at 4 mmol L -1  blood lactate concentration ([La - ]) before (Pre) and following three-weeks (3-Weeks) normal training (CON; n = 8) or normal training with 28 ± 2 min post-exercise sauna bathing (101-108 °C, 5-10%RH) 3 ± 1 times per week (SAUNA; n = 12). Changes from Pre to 3-Weeks were compared between-groups using an analysis of co-variance. Six SAUNA participants continued the intervention for 7 weeks, completing an additional HTT (7-Weeks; data compared using a one-way repeated-measures analysis of variance).
RESULTS


During the HTT, SAUNA reduced peak rectal temperature (T rec ; - 0.2 °C), skin temperature (- 0.8 °C), and heart rate (- 11 beats min -1 ) more than CON at 3-Weeks compared to Pre (all p < 0.05). SAUNA also improved [Formula: see text]O 2max  (+ 0.27 L -1  min -1 ; p = 0.02) and speed at 4 mmol L -1  [La - ] (+ 0.6 km h -1 ; p = 0.01) more than CON at 3-Weeks compared to Pre. Only peak T rec  (- 0.1 °C; p = 0.03 decreased further from 3-Weeks to 7-Weeks in SAUNA (other physiological variables p > 0.05).
CONCLUSIONS


Three-weeks post-exercise sauna bathing is an effective and pragmatic method of heat acclimation, and an effective ergogenic aid. Extending the intervention to seven weeks only marginally improved T rec .",2020,"Only peak T rec  (- 0.1 °C; p = 0.03 decreased further from 3-Weeks to 7-Weeks in SAUNA (other physiological variables p > 0.05).
","['trained middle-distance runners', 'Twenty middle-distance runners (13 female; mean\u2009±\u2009SD, age 20\u2009±\u20092\xa0years, [Formula: see text]O 2max']","['intermittent post-exercise sauna bathing across three-weeks endurance training', 'running heat tolerance test (30-min, 9\xa0km\xa0h -1 /2% gradient, 40\xa0°C/40%RH; HTT) and temperate (18\xa0°C) exercise tests (maximal aerobic capacity [[Formula: see text]O 2max ], speed at 4\xa0mmol\xa0L -1  blood lactate concentration ([La - ]) before (Pre) and following three-weeks (3-Weeks) normal training (CON; n\u2009=\u20098) or normal training with 28\u2009±\u20092\xa0min post-exercise sauna bathing']","['T rec ', 'skin temperature', 'peak rectal temperature', 'exercise heat tolerance and exercise performance markers', 'exercise capacity', 'heart rate']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0004836', 'cui_str': 'Sauna'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3544386', 'cui_str': 'Heat Tolerance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0439182', 'cui_str': '% gradient'}, {'cui': 'C5198254', 'cui_str': 'HTT(RX)'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}]","[{'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3544386', 'cui_str': 'Heat Tolerance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",6.0,0.0818179,"Only peak T rec  (- 0.1 °C; p = 0.03 decreased further from 3-Weeks to 7-Weeks in SAUNA (other physiological variables p > 0.05).
","[{'ForeName': 'Nathalie V', 'Initials': 'NV', 'LastName': 'Kirby', 'Affiliation': 'University of Birmingham, Birmingham, B15 2TT, UK. NXK650@bham.ac.uk.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Armstrong', 'Affiliation': 'Performance Centre, University of Birmingham Sport, Birmingham, UK.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Weaver', 'Affiliation': 'University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Rebekah A I', 'Initials': 'RAI', 'LastName': 'Lucas', 'Affiliation': 'University of Birmingham, Birmingham, B15 2TT, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04541-z']
2290,33211152,The positive effect of spermidine in older adults suffering from dementia : First results of a 3-month trial.,"The worldwide prevalence of dementia is estimated at 35.6 million and will rise to 115 million by 2050. There is therefore an urgent need for well-founded dementia diagnostics and well-researched therapeutic options. Previous studies have highlighted that spermidine has the ability to trigger the important process of dissolving amyloid-beta plaques by autophagy. They also confirmed that nutritional intervention with the natural polyamine spermidine can prevent memory loss in aging model organisms. This multicentric double-blind preliminary study focused on the effect of oral spermidine supplementation on older adults' cognitive performance. Memory tests were carried out on 85 subjects aged between 60 and 96 years in 6 nursing homes in Styria. Blood samples were taken for the determination of spermidine concentration and measurement of metabolic parameters. The results demonstrated a clear correlation between the intake of spermidine and the improvement in cognitive performance in subjects with mild and moderate dementia in the group treated with the higher spermidine dosage. The most substantial improvement in test performance was found in the group of subjects with mild dementia with an increase of 2.23 points (p = 0.026) in the mini mental state examination (MMSE) and 1.99 (p = 0.47) in phonematic fluidity. By comparison, the group which had a lower spermidine intake showed consistent or declining cognitive performance.",2020,The most substantial improvement in test performance was found in the group of subjects with mild dementia with an increase of 2.23 points (p = 0.026) in the mini mental state examination (MMSE) and 1.99 (p = 0.47) in phonematic fluidity.,"['older adults suffering from dementia ', '85\xa0subjects aged between\xa060 and 96\xa0years in 6 nursing homes in Styria', ""older adults' cognitive performance""]","['spermidine', 'oral spermidine supplementation']","['cognitive performance', 'memory loss']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0037871', 'cui_str': 'spermidine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0002622', 'cui_str': 'Amnesia'}]",,0.0464198,The most substantial improvement in test performance was found in the group of subjects with mild dementia with an increase of 2.23 points (p = 0.026) in the mini mental state examination (MMSE) and 1.99 (p = 0.47) in phonematic fluidity.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pekar', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria. pekar@fhwn.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bruckner', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Pauschenwein-Frantsich', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Gschaider', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Oppliger', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Willesberger', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Ungersbäck', 'Affiliation': 'Biomedical Science, University of Applied Sciences Wiener Neustadt, Johannes-Gutenberg-Str.\xa03, 2700, Wiener Neustadt, Austria.'}, {'ForeName': 'Aribert', 'Initials': 'A', 'LastName': 'Wendzel', 'Affiliation': 'Gepflegt Wohnen GmbH, 182, 8412, Allerheiligen bei Wildon, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kremer', 'Affiliation': 'Privatklinik Rudolfinerhaus GmbH, Billrothstr.\xa078, 1190, Vienna, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Flak', 'Affiliation': 'Federal Office for Viticulture, Gölbeszeile\xa01, 7000, Eisenstadt, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Wantke', 'Affiliation': 'FAZ Floridsdorfer Allergiezentrum, Pius-Parsch-Platz 1/3, 1210, Vienna, Austria.'}, {'ForeName': 'Reinhart', 'Initials': 'R', 'LastName': 'Jarisch', 'Affiliation': 'FAZ Floridsdorfer Allergiezentrum, Pius-Parsch-Platz 1/3, 1210, Vienna, Austria.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01758-y']
2291,33211314,Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib.,"BACKGROUND


Palbociclib is indicated for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC).
OBJECTIVE


Exposure-response analyses were conducted to evaluate efficacy in Asian versus non-Asian patients and in patients with versus without dose reduction in PALOMA-2.
PATIENTS AND METHODS


PALOMA-2 compared palbociclib plus letrozole versus placebo plus letrozole in patients with ABC. Population pharmacokinetic analysis provided apparent palbociclib clearance (CL/F) for each patient. The time-varying exposure metric, C avg,t , was calculated using average dose intensity and CL/F at the time of each progression-free survival (PFS) event. A Cox proportional model characterized PFS and palbociclib C avg,t  relationships. Significant prognostic factors for PFS were identified by univariate analysis, which were subsequently included in multivariate analyses, in addition to the C avg,t  effect on PFS. PFS profiles in Asian/non-Asian patients and patients with/without dose reduction were simulated and compared using observed palbociclib exposures and established exposure-response relationships.
RESULTS


Patients (n = 421) received palbociclib plus letrozole (Asian = 64, non-Asian = 357; no dose reduction = 272, dose reduction = 149). Based on univariate analyses, significant prognostic factors were Ki67 score, age, and baseline aspartate aminotransferase (BAST), tumor size, alkaline phosphatase, and albumin levels. In multivariate analysis, only Ki67 and BAST remained significant. Palbociclib exposure did not significantly affect PFS in either univariate (P = 0.12) or multivariate (P = 0.44) analyses.
CONCLUSIONS


This analysis suggests that palbociclib exposure has no impact on PFS when the dose reduction algorithm from palbociclib clinical trials is used. There is no difference in efficacy between Asians and non-Asians, despite the higher level of dose reductions in Asians.
PFIZER


NCT01740427.",2020,"Palbociclib exposure did not significantly affect PFS in either univariate (P = 0.12) or multivariate (P = 0.44) analyses.
","['Asian versus non-Asian patients and in patients with versus without dose reduction in PALOMA-2', 'Patients (n\u2009=\u2009421) received', 'patients with ABC']","['palbociclib plus letrozole', 'placebo plus letrozole']","['baseline aspartate aminotransferase (BAST), tumor size, alkaline phosphatase, and albumin levels', 'PFS', 'PFS profiles']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0729146,"Palbociclib exposure did not significantly affect PFS in either univariate (P = 0.12) or multivariate (P = 0.44) analyses.
","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Pharmacometrics, Global Product Development, Pfizer Inc, Col-D/006/D6400, 500 Arcola Rd., Collegeville, PA, 19426, USA. jenny.zheng@pfizer.com.'}, {'ForeName': 'Yanke', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Chandrasekar', 'Initials': 'C', 'LastName': 'Durairaj', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology Institut Curie, Paris and Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine at UCLA, Santa Monica, CA, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, San Diego, CA, USA.'}]",Targeted oncology,['10.1007/s11523-020-00771-5']
2292,33211326,Growth of Head Circumference and Body Length in Preterm Infants Receiving a Multicomponent vs a Soybean-Based Lipid Emulsion: A Randomized Controlled Trial.,"BACKGROUND


The growth of very low-birth-weight (VLBW) infants relies, to a large extent, on parenteral nutrition (PN) during the early weeks of life. Despite the parenteral nutrients supply, extrauterine growth restriction remains the main concern for these infants. A parenteral multicomponent lipid emulsion (MLE) might improve growth and neurological outcomes, delivering fats for brain growth that the traditional soybean-based lipid emulsion (SLE) fails to provide. We hypothesize that the use of an MLE in PN may reduce the loss of head circumference (HC) z-score from birth to 36 weeks' postmenstrual age (PMA) or at discharge compared with the use of an SLE in VLBW infants.
METHODS


Infants with BW ≤1250 g, without malformations or chromosomal abnormalities, were randomly assigned to receive an MLE or an SLE. The primary outcome was the change in HC z-score (HC Δ z-score) from birth to 36 weeks' PMA or at discharge. Secondary outcomes included the change in weight and length z-score (W Δ z-score and L Δ z-score) as well as incidence of late-onset sepsis and PN-associated cholestasis (PNAC).
RESULTS


Of the 128 infants randomized, 51 infants in the MLE group and 50 infants in the SLE group were analyzed. The MLE was significantly associated with a decreased loss in HC and length z-scores from birth to 36 weeks' PMA or at discharge.
CONCLUSIONS


This is the first randomized controlled trial providing the evidence that an MLE is associated with improved HC growth in comparison with a pure SLE.",2020,"The MLE was significantly associated with a decreased loss in HC and length z-scores from birth to 36 weeks' PMA or at discharge.
","['Infants with BW ≤1250 g, without malformations or chromosomal abnormalities', 'Preterm Infants Receiving a', '128 infants randomized, 51 infants in the MLE group and 50 infants in the SLE group were analyzed']","['MLE or an SLE', 'MLE', 'Multicomponent vs a Soybean-Based Lipid Emulsion', 'parenteral multicomponent lipid emulsion (MLE']","['Growth of Head Circumference and Body Length', 'loss in HC and length z-scores', 'change in weight and length z-score (W Δ z-score and L Δ z-score) as well as incidence of late-onset sepsis and PN-associated cholestasis (PNAC', 'loss of head circumference (HC) z-score', 'change in HC z-score (HC Δ z-score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0008370', 'cui_str': 'Cholestasis'}]",128.0,0.263066,"The MLE was significantly associated with a decreased loss in HC and length z-scores from birth to 36 weeks' PMA or at discharge.
","[{'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Costa', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cocca', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Barone', 'Affiliation': 'Neonatal Intensive Care Unit, Azienda Sanitaria Romagna, Infermi Hospital Rimini, Rimini, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Catenazzi', 'Affiliation': ""Neonatal Intensive Care Unit, Department of Women's and Children's Health, Maggiore Hospital, Bologna, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gallini', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Maggio', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Fusco', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vento', 'Affiliation': 'Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario, A, Gemelli IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1968']
2293,33211349,The Short-Term Effect of Occupational Levels of 50 Hz Electromagnetic Field on Human Heart Rate Variability.,"Previous studies have indicated that there is no consensus on the effects of extremely low-frequency electromagnetic (ELF-EMF) exposure on the cardiovascular system. This study aimed to explore the short-term effect of ELF-EMF exposure on heart rate (HR) and HR variability (HRV). The sample consisted of 34 healthy males aged 18-27 years. The participants were randomly assigned to the EMF (n = 17) or the Sham group (n = 17). We employed a double-blind repeated-measures design consisting of three 5 min experimental periods. The chest region of each individual in the EMF group was exposed to 50 Hz, 28 μT, linear polarized, continuous EMF during the EMF exposure period. HR and HRV data were recorded continuously by using a photoplethysmography sensor. Within-subject statistical analysis indicated a significant HR deceleration in both the EMF and Sham groups. However, the standard deviation of the NN intervals (SDNN), root mean square of successive differences (RMSSD), low-frequency (LF), and high-frequency (HF) powers increased only in the EMF group and remained stable in the Sham group. We also compared the same HRV indices measured during the EMF and Sham periods between the two experimental groups. The between-subject analysis results demonstrated significantly higher SDNN, RMSSD, LF, and HF values in the EMF group than in the Sham group. The LF/HF ratio did not change significantly within and between groups. On the basis of these results, we concluded that short-term exposure of the chest region to ELF-EMF could potentially enhance parasympathetic predominance during the resting condition. © 2020 Bioelectromagnetics Society.",2020,"The between-subject analysis results demonstrated significantly higher SDNN, RMSSD, LF, and HF values in the EMF group than in the Sham group.",['34 healthy males aged 18-27 years'],"['EMF', 'ELF-EMF']","['HR deceleration', 'Human Heart Rate Variability', 'LF/HF ratio', 'SDNN, RMSSD, LF, and HF values', 'HR and HRV data', 'heart rate (HR) and HR variability (HRV', 'parasympathetic predominance', 'standard deviation of the NN intervals (SDNN), root mean square of successive differences (RMSSD), low-frequency (LF), and high-frequency (HF) powers']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",34.0,0.0572011,"The between-subject analysis results demonstrated significantly higher SDNN, RMSSD, LF, and HF values in the EMF group than in the Sham group.","[{'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Binboğa', 'Affiliation': 'Department of Biophysics, Faculty of Medicine, Ege University, Izmir, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Tok', 'Affiliation': 'Faculty of Sport Sciences, Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Munzuroğlu', 'Affiliation': 'Department of Biophysics, Faculty of Medicine, Akdeniz University, Antalya, Turkey.'}]",Bioelectromagnetics,['10.1002/bem.22308']
2294,33211352,Topical 0.5% Timolol Maleate Significantly Enhances Skin-Barrier Restoration After Fractional Carbon Dioxide Laser Treatment for Acne Scars.,"BACKGROUND AND OBJECTIVES


Skin barrier is often compromised following ablative fractional carbon dioxide laser (AFCO 2  ) therapy for acne scarring. The resultant downtime, even of a few days' duration, can be of significant concern to patients. We evaluated the efficacy and safety of topical 0.5% timolol maleate (TM) for its role in short-term restoration of the skin's biophysical properties after laser treatments.
STUDY DESIGN/MATERIALS AND METHODS


This double-blind, placebo-controlled trial included participants aged 18-50 years with atrophic acne scars for at least 3 months. After undergoing laser therapy, they applied 0.5% TM to one cheek and normal saline to the contralateral cheek (control) for 7 days. Corneometry, transepidermal water loss (TEWL) measurement, colorimetry, and clinical outcome parameters (erythema, edema, crusting, pruritus, and tightness scores) were evaluated at baseline and 48, 96, and 168 hours after AFCO 2  treatment.
RESULTS


Twenty-five healthy participants completed the study. Most participants had Fitzpatrick skin phototype IV. The TM-treated side showed statistically higher corneometry values and lower TEWL than the control side at every follow-up visit (P < 0.001). The crusting score at 96 hours post-AFCO 2  treatment was also significantly better on the TM side. No adverse events occurred during the follow-up period.
CONCLUSIONS


Application of topical 0.5% TM twice daily improves the skin-barrier function and might promote re-epithelialization after laser procedures. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,The TM-treated side showed statistically higher corneometry values and lower TEWL than the control side at every follow-up visit (P < 0.001).,"['Twenty-five healthy participants completed the study', 'participants aged 18-50 years with atrophic acne scars for at least 3 months', 'acne scarring', 'Acne Scars']","['topical 0.5% timolol maleate (TM', 'Fractional Carbon Dioxide Laser Treatment', 'Topical 0.5% Timolol Maleate', 'placebo', 'ablative fractional carbon dioxide laser (AFCO 2  ) therapy']","['skin-barrier function', 'corneometry values and lower TEWL', 'crusting score', 'Skin-Barrier Restoration', 'efficacy and safety', 'adverse events', 'Fitzpatrick skin phototype IV', 'Corneometry, transepidermal water loss (TEWL) measurement, colorimetry, and clinical outcome parameters (erythema, edema, crusting, pruritus, and tightness scores']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0087093', 'cui_str': 'Timolol maleate'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009407', 'cui_str': 'Colorimetry'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}]",25.0,0.0667228,The TM-treated side showed statistically higher corneometry values and lower TEWL than the control side at every follow-up visit (P < 0.001).,"[{'ForeName': 'Kometh', 'Initials': 'K', 'LastName': 'Kimwattananukul', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nopadon', 'Initials': 'N', 'LastName': 'Noppakun', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chanat', 'Initials': 'C', 'LastName': 'Kumtornrut', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23354']
2295,33204076,Marked Reduction in 28-day Mortality Among Elderly Patients with Severe Community-acquired Pneumonia: Post Hoc Analysis of a Large Randomized Controlled Trial.,"Background


There were few studies on the case mortality of severe community-acquired pneumonia (CAP) in elderly people. Improved outcomes with XueBiJing (XBJ) injection vs placebo have been shown in overall trial populations. We investigated the efficacy and safety of XBJ vs placebo in subjects with severe CAP stratified by age (<65 and ≥65 years).
Methods


This post hoc analysis of a large randomized trial compared data from elderly and nonelderly patients with XBJ, 100 mL, q 12 h, or a visually indistinguishable placebo for five-to-seven days.
Results


Among subjects ≥65 years (n=291), 23 (16.0%) XBJ recipients and 41 (27.9%) placebo recipients ( P =0.014) died within 28 days. Among subjects <65 years (n=360), XBJ still had lower mortality (XBJ 15.6% vs placebo 22.8%;  P =0.082), without significantly statistical difference. Total duration of ICU stay and the time of mechanical ventilation were similar in both groups ( P >0.05). XBJ also had a favorable safety profile, with no clinically relevant differences between the two groups. The overall incidence of adverse events was similar in both groups.
Conclusion


XBJ was safe and effective for reduction in 28-day mortality among elderly patients with severe CAP. Additional confirmatory trials involving elderly patients are needed to further confirm the present results.
Trial Registration


http://www.chictr.org.cn/index.aspx. ChiCTR-TRC-13003534.",2020,Total duration of ICU stay and the time of mechanical ventilation were similar in both groups ( P >0.05).,"['elderly and nonelderly patients with XBJ, 100 mL, q 12 h, or a visually indistinguishable placebo for five-to-seven days', 'Elderly Patients with Severe Community-acquired Pneumonia', 'elderly people', 'elderly patients', 'elderly patients with severe CAP', 'subjects with severe CAP stratified by age (<65 and ≥65 years']","['XueBiJing (XBJ) injection vs placebo', 'XBJ vs placebo', 'placebo', 'XBJ']","['Total duration of ICU stay and the time of mechanical ventilation', 'lower mortality', 'efficacy and safety', '28-day mortality', '28-day Mortality', 'overall incidence of adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2933944', 'cui_str': 'Xuebijing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2933944', 'cui_str': 'Xuebijing'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.564319,Total duration of ICU stay and the time of mechanical ventilation were similar in both groups ( P >0.05).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.""}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Institute for Brain Disorders, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.""}, {'ForeName': 'Chengyu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.""}, {'ForeName': 'Chunxue', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': ""Department of Respiratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.""}, {'ForeName': 'Hongcai', 'Initials': 'H', 'LastName': 'Shang', 'Affiliation': ""Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.""}]",Clinical interventions in aging,['10.2147/CIA.S268140']
2296,33204077,Evaluation of the Effects of an Intervention Intended to Optimize the Sleep Environment Among the Elderly: An Exploratory Study.,"Purpose


The objective of this exploratory study was to evaluate the effects of a brief intervention intended to optimize the sleep environment in older people living in the community and to examine the way these effects change over time.
Methods


The sample was made up of 44 participants (19 men and 25 women) aged 65-85 years, with a mean age of 71.4. The intervention consisted in a group training session that covered the reasons for and ways to (""why"" and ""how"") optimize a sleep environment. It comprises six themes: air quality and odors, luminosity, noises and sounds, comfort of the mattress, comfort of the pillow, and temperature. Participants completed a set of questionnaires before the intervention, and one month and four months later.
Results


Four months after the intervention, the replies to the questionnaires showed that the participants experienced reduced severity of insomnia, sleep latency and anxiety. The subjective quality of the participants' sleep along with their sleep efficacy also increased significantly during the same period.
Conclusion


A brief intervention intended to optimize the sleep environment appears promising as an addition or alternative to the two other sleep improvement options generally offered to older people: medication and cognitive behavioral therapy.",2020,"Results


Four months after the intervention, the replies to the questionnaires showed that the participants experienced reduced severity of insomnia, sleep latency and anxiety.","['Elderly', 'older people living in the community', '44 participants (19 men and 25 women) aged 65-85 years, with a mean age of 71.4']",[],"[""subjective quality of the participants' sleep along with their sleep efficacy"", 'air quality and odors, luminosity, noises and sounds, comfort of the mattress, comfort of the pillow, and temperature', 'severity of insomnia, sleep latency and anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0182291', 'cui_str': 'Pillow'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0206564,"Results


Four months after the intervention, the replies to the questionnaires showed that the participants experienced reduced severity of insomnia, sleep latency and anxiety.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desjardins', 'Affiliation': 'Department of Psychology, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lapierre', 'Affiliation': 'Department of Psychology, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Helen-Maria', 'Initials': 'HM', 'LastName': 'Vasiliadis', 'Affiliation': 'Faculty of Medicine and Health Sciences, Université de Sherbrooke, Longueuil, Québec, Canada.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hudon', 'Affiliation': 'School of Psychology, Université Laval, Québec, Québec, Canada.'}]",Clinical interventions in aging,['10.2147/CIA.S277252']
2297,33204084,Effect of Inhaled Corticosteroid Withdrawal on Chronic Obstructive Pulmonary Disease Exacerbations in Patients Taking Triple Therapy at Baseline.,"Purpose


In the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial, inhaled corticosteroid (ICS) withdrawal in patients with chronic obstructive pulmonary disease receiving triple therapy (long-acting β 2 -agonist+long-acting muscarinic antagonist+ICS) did not change moderate/severe exacerbation risk. However, many patients were not taking triple therapy before study participation. This analysis was conducted to eliminate the impact of non-ICS users on WISDOM results by re-analyzing the data using only the subset of patients who were taking triple therapy at screening.
Patients and Methods


The effect of ICS withdrawal on moderate/severe exacerbation risk in the subgroup of WISDOM patients taking triple therapy before enrolling in the study was evaluated in this post hoc analysis. Additionally, the effect of ICS withdrawal in patients with a history of ≥2 exacerbations in the previous year and various blood eosinophil counts was assessed.
Results


Overall, 39.0% (n=970: ICS continuation, 479; ICS withdrawal, 491) of the WISDOM trial population were taking triple therapy at screening. Baseline characteristics were generally similar between groups. Moderate/severe exacerbation risk between the ICS withdrawal and continuation groups (hazard ratio [HR], 1.05; 95% confidence interval [CI]: 0.89-1.25) was not increased in patients taking triple therapy at screening versus the overall trial population (HR [95% CI]: 1.06 [0.94-1.19]). However, in patients with a history of ≥2 exacerbations, exacerbation risk (HR [95% CI]) increased nominally with blood eosinophil count from 1.07 [0.81-1.41] (≥100 cells/μL) to 1.45 [0.58-3.60] (≥400 cells/μL).
Conclusion


Consistent with results from the overall WISDOM trial population, ICS withdrawal did not increase exacerbation risk in patients taking triple therapy at screening. Patients with a history of frequent exacerbations and higher blood eosinophil counts could benefit from continuation of ICS-based therapy.",2020,"Overall, 39.0% (n=970: ICS continuation, 479; ICS withdrawal, 491) of the WISDOM trial population were taking triple therapy at screening.","['patients with chronic obstructive pulmonary disease receiving triple therapy (long-acting β 2 -agonist+long-acting muscarinic antagonist+ICS', 'Patients Taking Triple Therapy at Baseline']","['ICS withdrawal', 'Inhaled Corticosteroid Withdrawal', 'corticosteroid (ICS) withdrawal']","['Chronic Obstructive Pulmonary Disease Exacerbations', 'blood eosinophil counts', 'Moderate/severe exacerbation risk', 'blood eosinophil count', 'exacerbation risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0026815', 'cui_str': 'Muscarinics'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]","[{'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.500873,"Overall, 39.0% (n=970: ICS continuation, 479; ICS withdrawal, 491) of the WISDOM trial population were taking triple therapy at screening.","[{'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Shaikh', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tetzlaff', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Mueller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Helgo', 'Initials': 'H', 'LastName': 'Magnussen', 'Affiliation': 'Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S237408']
2298,33204086,Effects of TiO 2 -Coated Stainless Steel Orthodontic Wires on  Streptococcus mutans  Bacteria: A Clinical Study.,"Introduction


The aim of this study was to clinically evaluate  Streptococcus mutans  adhesion on titanium dioxide-coated stainless steel orthodontic wires to decrease white-spot formation.
Methods


In this study, four groups of 17 patients each (n=68) aged 12-25 years participated. A titanium dioxide coating layer was deposited on 0.4572 mm stainless steel orthodontic wires using physical vapor deposition. The coated wires were randomly assigned to one jaw, and the opposite jaw received an uncoated wire as control. Patients were divided into groups according to the duration that wires were in their mouths: A) 1 week, B) 2 weeks, C) 3 weeks, and D) 4 weeks. Block randomization was used to assign patients to each group. At the end of the experiment, 20 mm of each wire (canine-to-canine area) was cut and cultured in  S. mutans -specific medium. The culture plates were placed in an incubator containing 5% CO 2  for 72 hours at 37°C, and then colonies were counted. MTT was used to test the biocompatibility of the coated and uncoated wires. To evaluate the stability of the coated titanium dioxide layer on the wires, titanium concentration on the saliva was determined using inductively coupled plasma mass spectroscopy.
Results


The Kruskal-Wallis test showed that there was no significant difference in colony counts among the coated wires during 1-4 weeks ( p <0.48). In the uncoated-wire groups, colonys count at week 1 were higher than weeks 24 -( p <0.022). Wilcoxon's test showed that the number of colonies was significantly different in groups A and C, but there was no significant difference in groups B or D. MTT-assay results showed that there was not a significant difference between cell viability in the coated-wire group and the control. The Kruskal-Wallis test showed that there was no significant difference in titanium concentration in the studied groups ( p <0.834).
Conclusion


Application of titanium dioxide coating is effective in reducing bacterial adhesion at wire insertion.",2020,"Wilcoxon's test showed that the number of colonies was significantly different in groups A and C, but there was no significant difference in groups B or D. MTT-assay results showed that there was not a significant difference between cell viability in the coated-wire group and the control.",['four groups of 17 patients each (n=68) aged 12-25 years participated'],"['titanium dioxide coating', 'titanium dioxide-coated stainless steel orthodontic wires', 'opposite jaw received an uncoated wire as control', 'coated titanium dioxide layer', 'TiO 2 -Coated Stainless Steel Orthodontic Wires', 'titanium dioxide coating layer']","['number of colonies', 'colony counts', 'titanium concentration', 'bacterial adhesion', 'cell viability', 'colonys count']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0076733', 'cui_str': 'titanium dioxide'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0029334', 'cui_str': 'Orthodontic wire'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2355432', 'cui_str': 'oxo(5,10,15,20-tetra(4-pyridyl)porphyrinato)titanium(IV)'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004614', 'cui_str': 'Adhesions, Bacterial'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",,0.0389155,"Wilcoxon's test showed that the number of colonies was significantly different in groups A and C, but there was no significant difference in groups B or D. MTT-assay results showed that there was not a significant difference between cell viability in the coated-wire group and the control.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mollabashi', 'Affiliation': 'Orthodontic Department, Dental Faculty and Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Farmany', 'Affiliation': 'Dental Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad Yousef', 'Initials': 'MY', 'LastName': 'Alikhani', 'Affiliation': 'Department of Microbiology, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sattari', 'Affiliation': 'Division of Microstructure Physics, Department of Physics, Chalmers University of Technology, Gothenburg SE-412 96, Sweden.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Soltanian', 'Affiliation': 'Modeling of Noncommunicable Diseases Research Center, Department of Biostatistics and Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Parnian', 'Initials': 'P', 'LastName': 'Kahvand', 'Affiliation': 'Orthodontic Department, Dental Faculty, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Banisafar', 'Affiliation': 'Orthodontic Department, Dental Faculty, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",International journal of nanomedicine,['10.2147/IJN.S258440']
2299,33204262,Bupleuri Radix  Prevents the Recurrences of Resected Colonic Polyps by Affecting Angiogenin-2-Induced Protein Kinase B/Akt Signaling.,"Aim


We aimed to explore the effects of Bupleuri Radix (BR) on the recurrence of resected colonic polyp (CP) by measuring angiogenin-2-induced protein kinase B (Ang PKB)/Akt signaling.
Method


The main ingredients of BR were extracted by using ethanol and measured by HPLC. One hundred twenty patients with CP >10 mm who underwent resected surgery were randomly allocated to an aspirin (AG) or a BR medicine (BG) group. The allocation ratio was 1 : 1 and the intervention duration was one year. The recurrence rate of resected CP was investigated and the plasma levels of Ang PKB/Akt and inflammatory cytokines were measured using ELISA kits. After one-year surgery, side effects were recorded. The relationship between the serum levels of the main compounds of BR and plasma levels of Ang PKB/Akt was analyzed.
Results


The main ingredients of CP are paeoniflorin, baicalin, saikosaponin A, and bupleurum saponin B2. Recurrence of resected CP was found in 17 patients from the AG group and eight patients from the BG group after one-year follow-up ( p  < 0.05). The levels of angiogenin-2 II and PKB/Akt in the AG group were higher than those in the BG group ( p  < 0.05). Meanwhile, BR treatment reduced the plasma levels of TNF- α , IL-1 β,  and IL-6, and increased the level of IL-10( p  < 0.05). Inflammatory cytokines are important factors that affect the recurrence of resected CP. Serum paeoniflorin, baicalin, saikosaponin A, and bupleurum saponin B2 in BR had a strong negative relationship with the plasma levels of Ang PKB/Akt.
Conclusion


BR significantly reduces the recurrence risk of resected CP by affecting Ang PKB/Akt signaling.",2020,"Meanwhile, BR treatment reduced the plasma levels of TNF- α , IL-1 β,  and IL-6, and increased the level of IL-10( p  < 0.05).",['One hundred twenty patients with CP >10\u2009mm who underwent resected surgery'],"['Bupleuri Radix (BR', 'aspirin (AG) or a BR medicine (BG']","['Recurrence of resected CP', 'plasma levels of Ang PKB/Akt and inflammatory cytokines', 'recurrence rate of resected CP', 'side effects', 'Serum paeoniflorin, baicalin, saikosaponin A, and bupleurum saponin B2', 'plasma levels of TNF- α , IL-1 β,  and IL-6, and increased the level of IL-10', 'levels of angiogenin-2 II and PKB/Akt']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0242726', 'cui_str': 'Plant roots'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0009376', 'cui_str': 'Polyp of colon'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0051844', 'cui_str': 'Angiogenin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0070320', 'cui_str': 'peoniflorin'}, {'cui': 'C0052929', 'cui_str': 'baicalin'}, {'cui': 'C0377261', 'cui_str': 'saikosaponin A'}, {'cui': 'C0950082', 'cui_str': 'Bupleurum'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0668624', 'cui_str': 'AKT1 protein, human'}]",120.0,0.0512957,"Meanwhile, BR treatment reduced the plasma levels of TNF- α , IL-1 β,  and IL-6, and increased the level of IL-10( p  < 0.05).","[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Spleen and Stomach Disease, Yantai Hospital of Traditional Chinese Medicine, Yantai 264002, China.'}, {'ForeName': 'Guihong', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Department of Integrated TCM & Western Medicine, Yantai Qishan Hospital, Yantai 264000, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Laboratory, Yantai Wanhua Hospital, Yantai 260000, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Laboratory, Yantai Hospital of Traditional Chinese Medicine, Yantai 264002, China.'}]",Journal of oncology,['10.1155/2020/3531652']
2300,33204428,Use of convalescent plasma therapy in Eight mild COVID-19 patients.,"The coronavirus disease 2019 (COVID-19) is still global epidemic. Several studies of severe COVID-19 patients regard convalescent plasma (CP) transfusion as an effective therapy. However, there are no significant improvements in the randomized clinical trial of CP treatment. Until now, the data of mild COVID-19 patients transfused CP were lack. This study recruited 8 mild COVID-19 patients received at least one dose of CP transfusion. After CP therapy, all patients improved the clinical symptoms. The level of lymphocyte counts tended to increase, meanwhile LDH, CK and AST tended to decrease. However, CRP of 3 patients increased transiently. The median time that SARS-CoV-2 nucleic acid of the patients turned to negative was 2.5d after CP transfusion. The study shows the potential benefits of CP. Meanwhile, CP probably enhances the inflammatory response to SARS-CoV-2 temporarily in the patients with insufficient antiviral immunity. However, the effects of CP are not permanent.",2020,"The level of lymphocyte counts tended to increase, meanwhile LDH, CK and AST tended to decrease.",['Eight mild COVID-19 patients'],"['convalescent plasma therapy', 'CP', 'CP transfusion']","['median time that SARS-CoV-2 nucleic acid', 'meanwhile LDH, CK and AST', 'clinical symptoms', 'level of lymphocyte counts']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}]",8.0,0.0258169,"The level of lymphocyte counts tended to increase, meanwhile LDH, CK and AST tended to decrease.","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Department of Infectious Disease, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Disease, Fuyang Second Hospital, Fuyang, Anhui, China.'}, {'ForeName': 'Da-Ang', 'Initials': 'DA', 'LastName': 'Hao', 'Affiliation': 'Department of Infectious Disease, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ""Department of Infectious Disease, Yancheng Second People's Hospital, Yancheng, Jiangsu, China.""}, {'ForeName': 'Xue-Cheng', 'Initials': 'XC', 'LastName': 'Tong', 'Affiliation': ""Department of Infectious Disease, Changzhou Third People's Hospital, Jiangsu, China.""}, {'ForeName': 'Jun-Gui', 'Initials': 'JG', 'LastName': 'Hao', 'Affiliation': 'Department of Infectious Disease, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Chun-Yang', 'Initials': 'CY', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ming-Jia', 'Initials': 'MJ', 'LastName': 'Dai', 'Affiliation': 'Department of Infectious Disease, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xue-Bing', 'Initials': 'XB', 'LastName': 'Yan', 'Affiliation': 'Department of Infectious Disease, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}]",New microbes and new infections,['10.1016/j.nmni.2020.100814']
2301,33204529,Central Venous Catheter Insertion: A Scoring System for Evaluation of Both the Procedure and the Operator (CVCI Score/Gaber Score).,"Introduction


Currently, there is no method to assess the performance while inserting a central venous catheter. We suggest a new scoring system for evaluation of both the technique as well as the operator, and then we applied it for the comparison between the landmark and ultrasound techniques to assess its validity . Methods . Four hundred patients were divided into two equal groups: group (A): internal jugular vein (IJV) and group (B): subclavian vein (SV). The landmark technique and the ultrasound guidance were used equally (100 patients for each) in both groups.
Results


In group (A), 20% of patients in the landmark group achieved score 4, while 82% of patients in the ultrasound group achieved the same score. This suggests that the ultrasound technique for catheterization of IJV decreased overall complications and improved the success rate. In group (B), there were 70% of patients in the landmark group who achieved score 5, while 49% of patients in the ultrasound group achieved the same score which proposes that the landmark technique might be deceptively better than the ultrasound technique for catheterization of SV. This could be because the time required for catheterization of SV by the ultrasound technique was longer than that in the landmark technique. Overall complications of 15% with the landmark technique vs. 2% with ultrasound guidance in this group of patients are not only statistically significant but also increase morbidity and mortality with a highly invasive procedure. Complications and their incidences are by far more significant than seconds of time. Our results suggest that the ultrasound technique could decrease the incidence of overall complications, but it is time-consuming in group (B). These results support the validity of our new scoring system.
Conclusion


We suggest a new scoring system for CVC insertion that can be used for evaluation of both the technique and the operator. It can evaluate the performance of junior staff and follow their progress. It can be applied in the medical and critical care practice as well as the quality management privileges and protocols.",2020,We suggest a new scoring system for CVC insertion that can be used for evaluation of both the technique and the operator.,['Four hundred patients'],"['Central Venous Catheter Insertion', 'internal jugular vein (IJV) and group (B): subclavian vein (SV']","['incidence of overall complications', 'overall complications', 'Operator (CVCI Score/Gaber Score', 'morbidity and mortality', 'Overall complications']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",400.0,0.017061,We suggest a new scoring system for CVC insertion that can be used for evaluation of both the technique and the operator.,"[{'ForeName': 'Sayed', 'Initials': 'S', 'LastName': 'Gaber', 'Affiliation': 'Critical Care Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Yehia', 'Affiliation': 'Critical Care Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Beshoy', 'Initials': 'B', 'LastName': 'Nabil', 'Affiliation': 'Critical Care Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samir', 'Affiliation': 'Critical Care Medicine, Cairo University, Giza, Egypt.'}]",Critical care research and practice,['10.1155/2020/8156801']
2302,33205032,Long-term outcomes in patients with PET-predicted poor-responsive HER2-positive breast cancer treated with neoadjuvant bevacizumab added to trastuzumab and docetaxel: 5-year follow-up of the randomised Avataxher study.,"Background


The open-label, randomised Phase 2 AVATAXHER study (NCT01142778) demonstrated that early PET assessment identified HER2-positive breast cancer patients who responded poorly to neoadjuvant docetaxel plus trastuzumab. Adding neoadjuvant bevacizumab for PET-predicted poor-responders improved pathological complete response (pCR) rates (43.8% vs 24.0%). We investigated long-term study outcomes.
Methods


Patients were treated in three groups. All patients initially received two cycles of standard neoadjuvant therapy with [¹⁸F]-FDG PET conducted before each cycle. Those with ≥70% change in the maximum standardised uptake value (∆SUVmax) received four further cycles of standard neoadjuvant therapy (PET responders). PET-predicted poor-responders (∆SUVmax <70%) were randomised (2:1) to neoadjuvant therapy with (Group A) or without (Group B) bevacizumab for cycles 3-6. All patients received one further cycle of trastuzumab before surgery plus adjuvant trastuzumab (11 cycles).
Findings


142 patients were randomized and treated (PET responders,  n  = 69; Group A,  n  = 48; Group B,  n  = 25). 5-year disease-free survival rates were 90.5% (95% CI: 80.0-95.6%) in PET responders, 90.2% (95% CI: 75.9-96.2%) in Group A, and 76.0% (95% CI: 54.2-88.4%) in Group B. However, no difference was observed between randomised arms in a sensitivity analysis. During adjuvant therapy, the incidence of Grade ≥3 (Group A: 25.6%; Group B 12.5%) and serious adverse events (Group A: 18.6%; Group B 12.5%) was higher in Group A vs Group B, but with no apparent effect on cardiac events.
Interpretation


In patients with HER2-positive breast cancer, an intervention based on early PET assessment and improvement of pCR does not modify disease-free survival.
Funding


Roche France.",2020,"disease-free survival rates were 90.5% (95% CI: 80.0-95.6%) in PET responders, 90.2% (95% CI: 75.9-96.2%) in Group A, and 76.0% (95% CI: 54.2-88.4%) in Group B.","['HER2-positive breast cancer patients who responded poorly to', 'patients with HER2-positive breast cancer', '142 patients', 'patients with PET-predicted poor-responsive HER2-positive breast cancer treated with']","['bevacizumab', 'neoadjuvant bevacizumab', 'trastuzumab and docetaxel', 'standard neoadjuvant therapy with [¹⁸F]-FDG PET', 'trastuzumab before surgery plus adjuvant trastuzumab', 'neoadjuvant docetaxel plus trastuzumab']","['pathological complete response (pCR) rates', 'cardiac events', 'serious adverse events', 'disease-free survival rates']","[{'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",142.0,0.131535,"disease-free survival rates were 90.5% (95% CI: 80.0-95.6%) in PET responders, 90.2% (95% CI: 75.9-96.2%) in Group A, and 76.0% (95% CI: 54.2-88.4%) in Group B.","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Coudert', 'Affiliation': 'Centre Georges-Francois Leclerc, Dijon, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Institut Curie, Université de Paris, Paris, France.'}, {'ForeName': 'Marie-Ange', 'Initials': 'MA', 'LastName': 'Mouret-Reynier', 'Affiliation': 'Centre Jean Perrin, Clermont Ferrand, France.'}, {'ForeName': 'Kaldoun', 'Initials': 'K', 'LastName': 'Kerrou', 'Affiliation': 'Hopital Tenon, Paris, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Fanny Le', 'Initials': 'FL', 'LastName': 'Du', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Dupré', 'Affiliation': 'Centre Hospitalier Universitaire Augustin-Morvan, Brest, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Centre Léon Berard, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gabelle', 'Affiliation': 'Institut Daniel Hollard, Grenoble, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Chauvet', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coeffic', 'Affiliation': 'Polyclinique Courlancy, Institut du Cancer Courlancy Reims, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barbe', 'Affiliation': 'CHU Bretonneau, Tours, France.'}, {'ForeName': 'Jean-Briac', 'Initials': 'JB', 'LastName': 'Prevost', 'Affiliation': 'Centre Pierre Curie, Beuvry, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Paintaud', 'Affiliation': 'Université de Tours, CHRU de Tours, Tours, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Thibault', 'Affiliation': 'Université de Tours, CHRU de Tours, Tours, France.'}, {'ForeName': 'Abdennour', 'Initials': 'A', 'LastName': 'Ferhat', 'Affiliation': 'Roche France S.A.S., Boulogne Billancourt, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Dupin', 'Affiliation': 'Roche France S.A.S., Boulogne Billancourt, France.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Berriolo-Riedinger', 'Affiliation': 'Centre Georges-Francois Leclerc, Dijon, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Arnould', 'Affiliation': 'Centre Georges-Francois Leclerc, Dijon, France.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100566']
2303,33205201,Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study.,"AIMS 


Thermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (AF). Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent. We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury.
METHODS AND RESULTS 


A single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoETM device to protect the oesophagus from thermal injury. This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe. In the protected group, the device maintained the luminal temperature at 4°C during radiofrequency (RF) ablation for AF under general anaesthesia. Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored. The patient and the endoscopist were blinded to the randomization. We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27). There was no difference between groups in the duration of RF or in the force applied (P value range= 0.2-0.9). Procedure duration and fluoroscopy duration were similar (P = 0.97, P = 0.91, respectively).
CONCLUSION 


Thermal protection of the oesophagus significantly reduces ablation-related thermal injury compared with standard care. This method of oesophageal protection is safe and does not compromise the efficacy or efficiency of the ablation procedure.",2020,"Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27).","['188 patients, of whom 120 underwent endoscopy']",['oesophageal protection with a temperature control device'],"['gastroparesis', 'Procedure duration and fluoroscopy duration', 'duration of RF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",188.0,0.07525,"Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27).","[{'ForeName': 'Lisa W M', 'Initials': 'LWM', 'LastName': 'Leung', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Bajpai', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Zuberi', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Norman', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Riyaz A', 'Initials': 'RA', 'LastName': 'Kaba', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Zaki', 'Initials': 'Z', 'LastName': 'Akhtar', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Evranos', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Hanney', 'Initials': 'H', 'LastName': 'Gonna', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Harding', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Manav', 'Initials': 'M', 'LastName': 'Sohal', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Al-Subaie', 'Affiliation': 'Anesthetic Department, Anesthesia and Intensive Care Medicine, Kuwait Oil Company Ahmadi Hospital, Kuwait.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Louis-Auguste', 'Affiliation': ""Department of Gastroenterology, St. George's University Hospitals NHS Foundation Trust, St. George's, London, UK.""}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hayat', 'Affiliation': ""Department of Gastroenterology, St. George's University Hospitals NHS Foundation Trust, St. George's, London, UK.""}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Gallagher', 'Affiliation': ""Cardiology Department, Cardiology Clinical Academic Group, St. George's NHS Foundation Trust, London SW17 0QT, UK.""}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa276']
2304,33205343,Efficacy of platelet-rich plasma injections in patients with adhesive capsulitis of the shoulder.,"PURPOSE


The goal of this study is to investigate whether platelet-rich plasma (PRP) injections are effective in the management of adhesive capsulitis of the shoulder (AC). A triple-blind, randomized controlled trial was designed and conducted in a medical school hospital.
METHODS


32 adult patients with adhesive capsulitis (21 female, 11 male with a mean age of 57, ranging from 23 to 70) were included in this study. Patients had to have shoulder pain and restrictions in movements (at least 25% when compared to the other side, and at least in two directions) for three months minimum and nine months maximum. Patients were randomized to two groups, and one group took PRP injections for three times every two weeks, while the other group took saline injections in same frequency and volume. A standardized exercise program was also applied to all patients. Patients were evaluated with Shoulder Pain and Disability Index (SPADI), Visual Analogue Scales for pain and disability, ranges of movements, and use of analgesics in before, after, and third month after the initiation of the therapy.
RESULTS


Baseline comparisons between groups showed no differences. SPADI and ranges of motion in all directions showed significant improvements with therapy, and the group which took PRP injections showed better improvements when compared to the control group (p < 0.05). Visual Analogue Scale was found to be better for the PRP group after therapy and third month, and not for the control group (0.4 ± 1.06 and 0.17 ± 0.72 vs. 2.5 ± 2.6 and 2 ± 2.2, respectively, p < 0.05). Use of analgesics was not found to be significant for both groups (p > 0.05).
CONCLUSION


PRP injections were found to be effective in both pain and disability, and showed improvements in a restricted shoulder due to adhesive capsulitis. These findings might point out PRP as a therapeutic option in the management of adhesive capsulitis.",2020,"Visual Analogue Scale was found to be better for the PRP group after therapy and third month, and not for the control group (0.4 ± 1.06 and 0.17 ± 0.72 vs. 2.5 ± 2.6 and 2 ± 2.2, respectively, p < 0.05).","['patients with adhesive capsulitis of the shoulder', '32 adult patients with adhesive capsulitis (21 female, 11 male with a mean age of 57, ranging from 23 to 70', 'medical school hospital']","['PRP injections', 'standardized exercise program', 'platelet-rich plasma injections', 'platelet-rich plasma (PRP) injections']","['pain and disability', 'shoulder pain and restrictions in movements', 'Shoulder Pain and Disability Index (SPADI), Visual Analogue Scales for pain and disability, ranges of movements, and use of analgesics', 'Visual Analogue Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",32.0,0.0298473,"Visual Analogue Scale was found to be better for the PRP group after therapy and third month, and not for the control group (0.4 ± 1.06 and 0.17 ± 0.72 vs. 2.5 ± 2.6 and 2 ± 2.2, respectively, p < 0.05).","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Ünlü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey. brc---koc@hotmail.com.'}, {'ForeName': 'Funda Atamaz', 'Initials': 'FA', 'LastName': 'Çalış', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Karapolat', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}, {'ForeName': 'Asude', 'Initials': 'A', 'LastName': 'Üzdü', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}, {'ForeName': 'Göksel', 'Initials': 'G', 'LastName': 'Tanıgör', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey. gtanigor@windowslive.com.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kirazlı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Medical School, Bornova, 35100, İzmir, Turkey.'}]",International orthopaedics,['10.1007/s00264-020-04518-9']
2305,33205347,Introduction to a Special Section on the Effects of the Dating Matters Model on Secondary Outcomes: Results from a Comparative Effectiveness Cluster Randomized Controlled Trial.,"Teen dating violence (TDV) affects millions of young people in the USA each year (Basile et al. 2020) and is associated with a myriad of negative consequences across the lifespan, including placing individuals at greater risk for experiencing intimate partner violence (IPV) in their more permanent relationships in adulthood (Exner-Cortens et al. Pediatrics 131(1):71-78 Exner-Cortens et al. 2013; Exner-Cortens et al. Journal of Adolescent Health 60(2):176-183 Exner-Cortens et al. 2017). The CDC developed the Dating Matters®: Strategies to Promote Healthy Teen Relationships comprehensive prevention model to prevent TDV and its consequences among young people, and it was found to be effective at reducing TDV perpetration and victimization compared with another evidence-based program (Niolon et al. American Journal of Preventive Medicine 57(1):13-23 Niolon et al. 2019). Dating Matters addresses multiple risk and protective factors for TDV through its multiple components, many of which are shared risk and protective factors for other forms of violence and risk behaviors among adolescents. This article introduces this special section, which includes three papers examining these secondary outcomes of the Dating Matters comparative effectiveness, multi-site, longitudinal cluster randomized controlled trial and concludes with an invited commentary by Debman and Temple (in press). This introduction briefly discusses the Dating Matters comprehensive prevention model, the comparative effectiveness trial used to evaluate effectiveness, the outcomes examined by the three papers included in this special section and the commentary from external reviewers. This special section makes an important contribution to the field of violence prevention, highlighting a preventive intervention for TDV that addresses a constellation of risk and protective factors and demonstrating its effects on multiple adolescent risk and violence outcomes.",2020,Pediatrics 131(1):71-78,['57(1):13-23 Niolon'],['Preventive Medicine'],[],[],"[{'cui': 'C0033110', 'cui_str': 'Preventive medicine'}]",[],,0.0203373,Pediatrics 131(1):71-78,"[{'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Division of Violence Prevention, Centers for Disease Control and Prevention, 4770 Buford Highway, MS 106-10, Atlanta, GA, 30341, USA. pniolon@cdc.gov.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01187-3']
2306,33205362,"Pharmacological Interactions between the Dual Orexin Receptor Antagonist Daridorexant and Ethanol in a Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Four-Way Crossover Phase I Study in Healthy Subjects.","BACKGROUND


Daridorexant (ACT-541468) is a potent dual orexin receptor antagonist under development for the treatment of sleep disorders. Concomitant intake of ethanol and hypnotics has been shown to result in additive/supra-additive depression of the central nervous system, resulting in pronounced sedation.
OBJECTIVE


The aim of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) interactions between ethanol and daridorexant.
METHOD


This was a single-center, double-blind, placebo-controlled, randomized, four-way crossover study conducted in 19 healthy male/female subjects. Subjects received the following four treatments: ethanol with daridorexant, daridorexant alone, ethanol alone, and placebo. Daridorexant 50 mg and the matching placebo were administered as single oral tablets. Ethanol was infused intravenously and clamped at a level of 0.6 g/L for 5 h. The PK of ethanol and daridorexant were assessed and a battery of PD tests performed.
RESULTS


Concomitant administration of ethanol prolonged the time to reach maximum plasma concentrations (t max ) of daridorexant (median difference 1.25 h). No other relevant PK interactions were observed. Coadministration with ethanol produced a numerically greater impairment on saccadic peak velocity, body sway, visual analog scale (VAS) alertness, VAS alcohol intoxication, smooth pursuit, and adaptive tracking compared with daridorexant alone. All treatments were generally well tolerated without serious adverse events (AEs). The most commonly reported treatment-emergent AEs following coadministration of daridorexant and ethanol included somnolence, headache, fatigue, sudden onset of sleep, and dizziness.
CONCLUSIONS


Apart from a shift in t max , no relevant changes in PK parameters were observed following coadministration of daridorexant and ethanol. The coadministration led to reinforced drug actions that were, at most, indicative of infra-additive effects on certain PD markers. Patients will be advised not to consume ethanol with daridorexant.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03609775 (ClinicalTrials.gov Identifier).",2020,"Coadministration with ethanol produced a numerically greater impairment on saccadic peak velocity, body sway, visual analog scale (VAS) alertness, VAS alcohol intoxication, smooth pursuit, and adaptive tracking compared with daridorexant alone.","['19 healthy male/female subjects', 'Healthy Subjects']","['ethanol and daridorexant', 'Dual Orexin Receptor Antagonist Daridorexant and Ethanol', 'Ethanol', 'ethanol with daridorexant, daridorexant alone, ethanol alone, and placebo', 'ethanol', 'ethanol and hypnotics', 'placebo', 'Daridorexant 50\xa0mg and the matching placebo', 'Placebo']","['PK parameters', 'saccadic peak velocity, body sway, visual analog scale (VAS) alertness, VAS alcohol intoxication, smooth pursuit, and adaptive tracking', 'somnolence, headache, fatigue, sudden onset of sleep, and dizziness', 'tolerated without serious adverse events (AEs', 'time to reach maximum plasma concentrations', 'pharmacokinetic (PK) and pharmacodynamic (PD) interactions', 'relevant PK interactions']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0034158', 'cui_str': 'Smooth pursuit movement'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0919582', 'cui_str': 'Sudden onset of sleep'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1868979', 'cui_str': 'Pharmacodynamic interaction'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}]",19.0,0.457604,"Coadministration with ethanol produced a numerically greater impairment on saccadic peak velocity, body sway, visual analog scale (VAS) alertness, VAS alcohol intoxication, smooth pursuit, and adaptive tracking compared with daridorexant alone.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland. benjamin.berger@idorsia.com.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}]",CNS drugs,['10.1007/s40263-020-00768-8']
2307,33205673,TPMT  polymorphisms and minimal residual disease after 6-mercaptopurine post-remission consolidation therapy of childhood acute lymphoblastic leukaemia.,"Bone marrow minimal residual disease (MRD) is the strongest predictor of relapse in children with acute lymphoblastic leukemia (ALL). 6-mercaptopurine (6MP) in ALL therapy has wide inter-individual variation in disposition and is strongly influenced by polymorphisms in the thiopurine methyltransferase ( TPMT ) gene. In 952 patients treated according to the NOPHO ALL2008 protocol, we explored the association between thiopurine disposition,  TPMT  genotypes and MRD levels after consolidation therapy with 6MP, high-dose methotrexate (HD-MTX), asparaginase, and vincristine. The levels of the cytotoxic DNA-incorporated thioguanine were significantly higher on day 70-79 in G460A/A719G  TPMT  heterozygous ( TPMT   HZ ) compared to  TPMT  wild type ( TPMT   WT ) patients (mean: 230.7 vs. 149.7 fmol/µg DNA, p = 0.002). In contrast,  TPMT  genotype did not associate with the end of consolidation MRD levels irrespective of randomization of the patients to fixed dose (25 mg/m 2 /day) or 6MP escalation (up to 50 or 75 mg/m 2 /day) during consolidation therapy.",2020,"The levels of the cytotoxic DNA-incorporated thioguanine were significantly higher on day 70-79 in G460A/A719G  TPMT  heterozygous ( TPMT   HZ ) compared to  TPMT  wild type ( TPMT   WT ) patients (mean: 230.7 vs. 149.7 fmol/µg DNA, p = 0.002).","['childhood acute lymphoblastic leukaemia', '952 patients treated according to the NOPHO ALL2008 protocol', 'children with acute lymphoblastic leukemia (ALL']","['6-mercaptopurine', '6-mercaptopurine post-remission consolidation therapy', '6MP escalation', 'consolidation therapy with 6MP, high-dose methotrexate (HD-MTX), asparaginase, and vincristine']","['thiopurine disposition,  TPMT  genotypes and MRD levels', 'levels of the cytotoxic DNA-incorporated thioguanine']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}]","[{'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C1175200', 'cui_str': '2-(3-(2-thioxopyrrolidin-3-ylidene)methyl)tryptophan'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0039902', 'cui_str': 'Thioguanine'}]",952.0,0.0141797,"The levels of the cytotoxic DNA-incorporated thioguanine were significantly higher on day 70-79 in G460A/A719G  TPMT  heterozygous ( TPMT   HZ ) compared to  TPMT  wild type ( TPMT   WT ) patients (mean: 230.7 vs. 149.7 fmol/µg DNA, p = 0.002).","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dreisig', 'Affiliation': 'Pediatric Oncology research laboratory, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emilie Damgaard', 'Initials': 'ED', 'LastName': 'Brünner', 'Affiliation': 'Pediatric Oncology research laboratory, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Hanne V', 'Initials': 'HV', 'LastName': 'Marquart', 'Affiliation': 'The Tissue Typing Laboratory, Department of Clinical Immunology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Louise Rold', 'Initials': 'LR', 'LastName': 'Helt', 'Affiliation': 'Pediatric Oncology research laboratory, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Nersting', 'Affiliation': 'Pediatric Oncology research laboratory, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Leth', 'Initials': 'TL', 'LastName': 'Frandsen', 'Affiliation': 'Department of Pediatrics and adolescent medicine, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Olafur Gisli', 'Initials': 'OG', 'LastName': 'Jonsson', 'Affiliation': 'Department of Pediatrics, University of Iceland, Reykjavík, Iceland.'}, {'ForeName': 'Mervi', 'Initials': 'M', 'LastName': 'Taskinen', 'Affiliation': 'Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Children and Adolescents, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Goda', 'Initials': 'G', 'LastName': 'Vaitkeviciene', 'Affiliation': ""Children's Hospital, Vilnius University Hospital Santaros Klinikos and Vilnius University, Vilnius, Lithuania.""}, {'ForeName': 'Bendik', 'Initials': 'B', 'LastName': 'Lund', 'Affiliation': 'Department of Pediatrics, St. Olavs Hospital, Trondheim; Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Abrahamsson', 'Affiliation': 'Department of Pediatrics, Institution for Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Lepik', 'Affiliation': ""Tallinn Children's Hospital, Tallinn, Estonia.""}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Pediatric Oncology research laboratory, The University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",Pediatric hematology and oncology,['10.1080/08880018.2020.1842570']
2308,33205676,The effects of easy goals versus difficult goals on acquisition and retention of a sport skill in children with intellectual disability.,"The purpose of the present study was to examine the effects of easy goals versus difficult goals on acquisition and retention of basketball free throws in children with intellectual disability. Twenty-one children with intellectual disability were randomly assigned to an easy goals or difficult goals group. The participants were required to improve their basketball free throws according to their own scores in the previous exercise session. More difficult goals were set for the difficult goals group than for the easy goals group. The groups exercised the task for nine sessions. Both groups performed pretest, acquisition, and retention tests. Results showed that participants with easy goals improved their performance while the participants with difficult goals failed to improve their performance. These findings indicate that providing children with intellectual disability with easy goals facilitates the process of sport skill learning.",2020,Results showed that participants with easy goals improved their performance while the participants with difficult goals failed to improve their performance.,"['Twenty-one children with intellectual disability', 'children with intellectual disability']",['easy goals or difficult goals group'],[],"[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],21.0,0.0141443,Results showed that participants with easy goals improved their performance while the participants with difficult goals failed to improve their performance.,"[{'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': '48437University of Isfahan, Iran.'}, {'ForeName': 'Mehdi Rafei', 'Initials': 'MR', 'LastName': 'Borujeni', 'Affiliation': '48437University of Isfahan, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Movahedi', 'Affiliation': '48437University of Isfahan, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Salehi', 'Affiliation': '48437University of Isfahan, Iran.'}]",Journal of intellectual disabilities : JOID,['10.1177/1744629520970076']
2309,33205741,Immunogenicity and Protective Efficacy of Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines in Equatoguinean Adults.,"Plasmodium falciparum  sporozoite (PfSPZ) Vaccine (radiation-attenuated, aseptic, purified, cryopreserved PfSPZ) and PfSPZ-CVac (infectious, aseptic, purified, cryopreserved PfSPZ administered to subjects taking weekly chloroquine chemoprophylaxis) have shown vaccine efficacies (VEs) of 100% against homologous controlled human malaria infection (CHMI) in nonimmune adults.  Plasmodium falciparum  sporozoite-CVac has never been assessed against CHMI in African vaccinees. We assessed the safety, immunogenicity, and VE against homologous CHMI of three doses of 2.7 × 10 6  PfSPZ of PfSPZ Vaccine at 8-week intervals and three doses of 1.0 × 10 5  PfSPZ of PfSPZ-CVac at 4-week intervals with each arm randomized, double-blind, placebo-controlled, and conducted in parallel. There were no differences in solicited adverse events between vaccinees and normal saline controls, or between PfSPZ Vaccine and PfSPZ-CVac recipients during the 6 days after administration of investigational product. However, from days 7-13, PfSPZ-CVac recipients had significantly more AEs, probably because of Pf parasitemia. Antibody responses were 2.9 times higher in PfSPZ Vaccine recipients than PfSPZ-CVac recipients at time of CHMI. Vaccine efficacy at a median of 14 weeks after last PfSPZ-CVac dose was 55% (8 of 13,  P  = 0.051) and at a median of 15 weeks after last PfSPZ Vaccine dose was 27% (5 of 15,  P  = 0.32). The higher VE in PfSPZ-CVac recipients of 55% with a 27-fold lower dose was likely a result of later stage parasite maturation in the liver, leading to induction of cellular immunity against a greater quantity and broader array of antigens.",2020,"There were no differences in solicited adverse events between vaccinees and normal saline controls, or between PfSPZ Vaccine and PfSPZ-CVac recipients during the 6 days after administration of investigational product.","['African vaccinees', 'Equatoguinean Adults']","['Radiation-Attenuated and Chemo-Attenuated PfSPZ Vaccines', 'placebo', 'PfSPZ Vaccine', 'chloroquine chemoprophylaxis', 'Plasmodium falciparum  sporozoite (PfSPZ) Vaccine (radiation-attenuated, aseptic, purified, cryopreserved PfSPZ) and PfSPZ-CVac (infectious, aseptic, purified, cryopreserved PfSPZ']","['solicited adverse events', 'Immunogenicity and Protective Efficacy', 'Vaccine efficacy', 'Antibody responses', 'Pf parasitemia', 'safety, immunogenicity, and VE against homologous CHMI']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0054932', 'cui_str': 'CCV-AV protocol'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0630847', 'cui_str': '1-acetyl-1,2,3,3a,8,8a-hexahydro-8a-hydroxy-5-methoxypyrrolo(2,3-b)indole'}]",,0.13914,"There were no differences in solicited adverse events between vaccinees and normal saline controls, or between PfSPZ Vaccine and PfSPZ-CVac recipients during the 6 days after administration of investigational product.","[{'ForeName': 'Said A', 'Initials': 'SA', 'LastName': 'Jongo', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Urbano', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'L W Preston', 'Initials': 'LWP', 'LastName': 'Church', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Ally', 'Initials': 'A', 'LastName': 'Olotu', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Manock', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schindler', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mtoro', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kc', 'Affiliation': 'Protein Potential LLC, Rockville, Maryland.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hamad', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nyakarungu', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'Mpina', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Deal', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'José Raso', 'Initials': 'JR', 'LastName': 'Bijeri', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Martin Eka', 'Initials': 'ME', 'LastName': 'Ondo Mangue', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Beltrán Ekua', 'Initials': 'BE', 'LastName': 'Ntutumu Pasialo', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Genaro Nsue', 'Initials': 'GN', 'LastName': 'Nguema', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Salomon Nguema', 'Initials': 'SN', 'LastName': 'Owono', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Matilde Riloha', 'Initials': 'MR', 'LastName': 'Rivas', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Mwajuma', 'Initials': 'M', 'LastName': 'Chemba', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Kamaka R', 'Initials': 'KR', 'LastName': 'Kassim', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stabler', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Saverino', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sax', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Salome', 'Initials': 'S', 'LastName': 'Hosch', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Anneth-Mwasi', 'Initials': 'AM', 'LastName': 'Tumbo', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gondwe', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'J Luis', 'Initials': 'JL', 'LastName': 'Segura', 'Affiliation': 'Medical Care Development International, Silver Spring, Maryland.'}, {'ForeName': 'Carlos Cortes', 'Initials': 'CC', 'LastName': 'Falla', 'Affiliation': 'Medical Care Development International, Silver Spring, Maryland.'}, {'ForeName': 'Wonder Philip', 'Initials': 'WP', 'LastName': 'Phiri', 'Affiliation': 'Medical Care Development International, Silver Spring, Maryland.'}, {'ForeName': 'Dianna E B', 'Initials': 'DEB', 'LastName': 'Hergott', 'Affiliation': 'Medical Care Development International, Silver Spring, Maryland.'}, {'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Garcia', 'Affiliation': 'Medical Care Development International, Silver Spring, Maryland.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schwabe', 'Affiliation': 'Medical Care Development International, Silver Spring, Maryland.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Maas', 'Affiliation': 'Marathon EG Production, Ltd., Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Tanner', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': ""Mitoha Ondo'o"", 'Initials': 'MO', 'LastName': 'Ayekaba', 'Affiliation': 'Ministry of Health and Social Welfare, Government of Equatorial Guinea, Bioko Norte, Equatorial Guinea.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Protein Potential LLC, Rockville, Maryland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Daubenberger', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abdulla', 'Affiliation': 'Ifakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc., Rockville, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0435']
2310,33205810,SGLT2 inhibition versus sulfonylurea treatment effects on electrolyte and acid-base balance: secondary analysis of a clinical trial reaching glycemic equipoise.,"SGLT2 inhibitors increase plasma magnesium and plasma phosphate and may cause ketoacidosis, but the contribution of improved glycemic control to these observations as well as effects on other electrolytes and acid-base parameters, remain unknown. Therefore, our objective was to compare the effects of SGLT2 inhibitors dapagliflozin and sulfonylurea gliclazide on plasma electrolytes, urinary electrolyte excretion, and acid-base balance in people with type 2 diabetes (T2D). We assessed the effects of dapagliflozin and gliclazide treatment on plasma electrolytes and bicarbonate, 24-hour urinary pH and excretions of electrolytes, ammonium, citrate, and sulfate in 44 metformin-treated people with T2D and preserved kidney function. Compared to gliclazide, dapagliflozin increased plasma chloride by 1.4 mmol/l (95% CI 0.4 to 2.4), plasma magnesium by 0.03 mmol/l (95% CI 0.01 to 0.06), and plasma sulfate by 0.02 mmol/l (95% CI 0.01 to 0.04). Compared to baseline, dapagliflozin also significantly increased plasma phosphate, but the same trend was observed with gliclazide. From baseline to week 12, dapagliflozin increased the urinary excretion of citrate by 0.93 ± 1.72 mmol/day, acetoacetate by 48 µmol/day (IQR -17 to 138), and β-hydroxybutyrate by 59 µmol/day (IQR 0 to 336), without disturbing acid-base balance. Dapagliflozin increases plasma magnesium, chloride, and sulfate compared with gliclazide, while reaching similar glucose-lowering in people with T2D. Dapagliflozin increases urinary ketone excretion without changing acid-base balance. Therefore, the increase in urinary citrate excretion by dapagliflozin may reflect an effect on cellular metabolism including the tricarboxylic acid cycle. This potentially contributes to kidney protection.",2020,"From baseline to week 12, dapagliflozin increased the urinary excretion of citrate by 0.93 ± 1.72 mmol/day, acetoacetate by 48 µmol/day (IQR -17 to 138), and β-hydroxybutyrate by 59 µmol/day (IQR 0 to 336), without disturbing acid-base balance.","['people with type 2 diabetes (T2D', '44 metformin-treated people with T2D and preserved kidney function']","['gliclazide', 'SGLT2 inhibitors', 'sulfonylurea', 'gliclazide, dapagliflozin', 'Dapagliflozin', 'SGLT2 inhibitors dapagliflozin and sulfonylurea gliclazide', 'dapagliflozin and gliclazide', 'dapagliflozin']","['plasma sulfate', 'urinary citrate excretion', 'plasma chloride', 'plasma electrolytes and bicarbonate, 24-hour urinary pH and excretions of electrolytes, ammonium, citrate, and sulfate', 'urinary excretion of citrate', 'plasma magnesium', 'plasma electrolytes, urinary electrolyte excretion, and acid-base balance', 'plasma phosphate', 'urinary ketone excretion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0858097', 'cui_str': 'Plasma chloride'}, {'cui': 'C0858120', 'cui_str': 'Plasma electrolytes NOS'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0858137', 'cui_str': 'Plasma magnesium'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}]",,0.14678,"From baseline to week 12, dapagliflozin increased the urinary excretion of citrate by 0.93 ± 1.72 mmol/day, acetoacetate by 48 µmol/day (IQR -17 to 138), and β-hydroxybutyrate by 59 µmol/day (IQR 0 to 336), without disturbing acid-base balance.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Bommel', 'Affiliation': 'Amsterdam UMC, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Geurts', 'Affiliation': 'Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Muskiet', 'Affiliation': 'Amsterdam UMC, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Post', 'Affiliation': 'UMCG, Groningen, Alaska, Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bakker', 'Affiliation': 'University Medical Center Groningen / University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Touw', 'Affiliation': 'UMCG, Groningen, Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'van Berkel', 'Affiliation': 'Radboud UMC, Nijmegen, Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Amsterdam UMC, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Amsterdam UMC, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'Ele', 'Initials': 'E', 'LastName': 'Ferrannini', 'Affiliation': 'University of Pisa School of Medicine, Pisa, Italy.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Erasmus MC, Rotterdam, Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'van Raalte', 'Affiliation': 'Amsterdam UMC, location VUMC, Amsterdam, Netherlands.'}]","Clinical science (London, England : 1979)",['10.1042/CS20201274']
2311,33205847,"Evaluation of a new spinal surgical robotic system of Kirschner wire placement for lumbar fusion: A multi-center, randomized controlled clinical study.","BACKGROUND


To introduce a novel robotic system ""Orthbot"" that has been developed and tested as a surgical assistant for auto-placement of the K-wire in lumbar fusion.
METHODS


A This is a multi-center, RCT randomized controlled clinical study contain that includes 56 patients (Robot Group, RG: 27, Free-hand Group, FG: 29). Following the preoperative planning and intraoperative fluoroscopic images, the ""Orthbot"" automatically completed registration and K-wire placement under the supervision of the surgeon. Deviation Distance (DD) and Deviation Angle (DA) were used as important the primary parameters to evaluate the accuracy of the robotic system.
RESULTS


The average DD was 0.95±0.377 mm (RG) and 4.35±2.01 mm (FG), respectively in the RG and FG (P<0.001). The average DA of the K-wire in the coronal plane and the sagittal plane in X-Ray was respectively 6.80±7.79° (RG) and 1.27±2.32° (RG) in the RG (P<0.001), and 22.22±16.85°(FG) and 4.57±3.86° (FG) in the FG (P<0.001), which showed a higher accuracy of rate in the robotic-assisted cases compared to the free-hand cases.
CONCLUSIONS


The novel robotic system could achieve accurate radiological results in K-wires insertions as indicated by the radiological results. This article is protected by copyright. All rights reserved.",2020,"Following the preoperative planning and intraoperative fluoroscopic images, the ""Orthbot"" automatically completed registration and K-wire placement under the supervision of the surgeon.","['lumbar fusion', '56 patients (Robot Group, RG: 27, Free-hand Group, FG: 29']",['Kirschner wire placement'],"['average DD', 'Deviation Distance (DD) and Deviation Angle (DA']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0275572,"Following the preoperative planning and intraoperative fluoroscopic images, the ""Orthbot"" automatically completed registration and K-wire placement under the supervision of the surgeon.","[{'ForeName': 'Junyu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Sun Yat-sen Memorial Hospital, Guangzhou, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Zizhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zongze', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhongjun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Huiyong', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Sun Yat-sen Memorial Hospital, Guangzhou, China.'}, {'ForeName': 'Zhaopeng', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Sun Yat-sen Memorial Hospital, Guangzhou, China.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': ""Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xinjian', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Wanheng', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Science and Technology Studies, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jianting', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Southern Medical University Nanfang Hospital, Guangzhou, China.'}]",The international journal of medical robotics + computer assisted surgery : MRCAS,['10.1002/rcs.2207']
2312,33206794,"Effects of green tea extract combined with brisk walking on lipid profiles and the liver function in overweight and obese men: A randomized, double-blinded, placebo-control trial.","This study was aimed to investigate the effect of green tea extract (GTE) combined with brisk walking on lipid profiles and the liver function in overweight and obese men. Twenty-four participants were randomized to either the GTE group or the placebo group for 12 weeks with a 4-week follow-up. The walking program consisted of four 60-min-sessions/week and all participants were asked to consume two GTE (150mg) or placebo tablets daily. After 12-week intervention, GTE group resulted in a significant difference in the low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) levels when compared to placebo group (P < 0.01). There was also a significant reduction in the aspartate aminotransferase levels (P < 0.01) in the GTE group, but no change in the placebo group (P >0.05). There was no change in the triglyceride or high-density lipoprotein cholesterol (HDL-C) levels in the placebo group, but a significant reduction was noted in the HDL-C levels in the GTE group (P < 0.05). GTE combined with brisk walking resulted in a significant change in the LDL-C and TC levels, however, a significant reduce in HDL-C in the GTE group. The study has a more positive effect on the liver function than brisk walking alone.",2020,"There was no change in the triglyceride or high-density lipoprotein cholesterol (HDL-C) levels in the placebo group, but a significant reduction was noted in the HDL-C levels in the GTE group (P < 0.05).",['overweight and obese men'],"['GTE', 'GTE combined with brisk walking', 'placebo', 'green tea extract combined with brisk walking', 'placebo tablets daily', 'green tea extract (GTE) combined with brisk walking']","['liver function', 'lipid profiles', 'LDL-C and TC levels', 'triglyceride or high-density lipoprotein cholesterol (HDL-C) levels', 'HDL-C', 'HDL-C levels', 'aspartate aminotransferase levels', 'low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}]",,0.201635,"There was no change in the triglyceride or high-density lipoprotein cholesterol (HDL-C) levels in the placebo group, but a significant reduction was noted in the HDL-C levels in the GTE group (P < 0.05).","[{'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Kyushu University, Faculty of Human-Environment Studies, 744 Motooka, Nishi-ku, 8190395, Fukuoka City, Japan.'}, {'ForeName': 'Ningxia', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Luohe Central of Hospital, The center laboratory, 56 Renmin East road, Luohe City, 462000, Henan Province, China.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Chen', 'Affiliation': 'Kyushu University, Faculty of Human-Environment Studies, 744 Motooka, Nishi-ku, 8190395, Fukuoka City, Japan.'}, {'ForeName': 'Zhenqing', 'Initials': 'Z', 'LastName': 'Hou', 'Affiliation': 'Luohe Central of Hospital, Assistant in Post-Doctoral Research Center, 56 Renmin East road, Luohe City 462000, Henan Province, China.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Kyushu University, Faculty of Human-Environment Studies, 744 Motooka, Nishi-ku, 8190395, Fukuoka City, Japan.'}]",Anais da Academia Brasileira de Ciencias,['10.1590/0001-3765202020191594']
2313,33209088,Brain protective effect and hemodynamics of dexmedetomidine hydrochloride in patients with intracranial aneurysm.,"The purpose of the study was to investigate the effect of dexmedetomidine hydrochloride (Dex) on the recovery of cognitive function, hemodynamics, and postoperative analgesia in patients undergoing intracranial aneurysm craniotomy.
METHODS


general anesthesia was performed on patients undergoing intracranial aneurysm craniotomy in neurosurgery. Patients were randomly divided into three groups: Dex 1 group (Dex dose: 1 μg/kg), Dex 2 group (Dex dose: 0.5 μg/kg), and blank control group (normal saline). The changes of heart rate, arterial pressure, intraoperative brain function index, and postoperative pain score were recorded and compared.
RESULTS


in Dex 1 group and Dex 2 group, the heart rate of T1 and T2 phase was significantly lower than that of T3-T7 phases (P < 0.05); compared with the control group, the heart rate of Dex 1 group and Dex 2 group was significantly lower (P < 0.05). The average arterial pressure of the control group and Dex groups was significantly different (P < 0.05). Compared with the control group, there were significant differences between Dex 1 group and Dex 2 group: S100 β protein in T7-T10, NSE (neuron specific enolase) in T9 and T10, pain score in T8, T9 and T10 after operation.
CONCLUSION


the application of Dex in the resection of intracranial aneurysms can protect the brain of patients, minimize the influence of operation on hemodynamics, and relieve postoperative pain, which is worthy of clinical application.",2020,"Compared with the control group, there were significant differences between Dex 1 group and Dex 2 group: S100 β protein in T7-T10, NSE (neuron specific enolase) in T9 and T10, pain score in T8, T9 and T10 after operation.
","['patients undergoing intracranial aneurysm craniotomy in neurosurgery', 'patients with intracranial aneurysm', 'patients undergoing intracranial aneurysm craniotomy']","['Dex', 'dexmedetomidine hydrochloride', 'Dex 1 group (Dex dose: 1\xa0μg/kg), Dex 2 group (Dex dose: 0.5\xa0μg/kg), and blank control group (normal saline', 'dexmedetomidine hydrochloride (Dex']","['S100 β protein in T7-T10, NSE (neuron specific enolase) in T9 and T10, pain score', 'average arterial pressure', 'heart rate', 'cognitive function, hemodynamics, and postoperative analgesia', 'heart rate, arterial pressure, intraoperative brain function index, and postoperative pain score', 'heart rate of T1 and T2 phase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}]","[{'cui': 'C0752310', 'cui_str': 'Dexmedetomidine hydrochloride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",,0.0183899,"Compared with the control group, there were significant differences between Dex 1 group and Dex 2 group: S100 β protein in T7-T10, NSE (neuron specific enolase) in T9 and T10, pain score in T8, T9 and T10 after operation.
","[{'ForeName': 'Deli', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Clinical Laboratory, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China.'}]",Saudi journal of biological sciences,['10.1016/j.sjbs.2020.03.027']
2314,33209216,Effect of Educational Program based on the Theory of Planned Behavior on Prostate Cancer Screening: A Randomized Clinical Trial.,"Background and Aims


Prostate cancer screening applied for early diagnosis of prostate cancer. But it is not usually pursued by men. This study was conducted to determine the effect of educational program based on the Theory of Planned Behavior (TPB) on prostate cancer screening.
Methods


A randomized clinical trial was carried out on 68 middle-aged men referring to community houses in Iran. Samples were selected consecutively considering the inclusion criteria. Then block randomization was used to assign the participants into two groups. Data collection included demographic characteristics, knowledge and construct of TPB (Attitude towards the behavior, Subjective norms, Perceived behavioral control, behavioral intention) and behavior. The participants in the intervention group attended a theory based program 4 session twice per week. The participants were evaluated before and two month after the intervention.  P  <0.05 was considered statistically significant.
Results


After the 2 months intervention, the pretest-posttest changes in the intervention group compared to the control group were in the Knowledge 9.26 ± 3.5 vs. 0.03 ± 1.68, Attitude 11.46 ± 3.5 vs. -0.16 ± 1.39, Subjective norms 3.16 ± 2.6 vs. 0.29 ± 1.3, Behavioral control 6.76 ± 4 vs. 0.12 ± 1.60 and Behavioral intention 1.4 ± 1.54 vs. 0.00 ± 1.00 ( P  < 0.05). While none of the subjects in control group performed the prostate screening, 10 people (33.2%) performed it in the intervention group. ( P  < 0.001).
Conclusions


Educational program based on TPB has a positive effect on prostate cancer screening. It is recommended to set up regular training programs based on TPB to encourage middle-aged men for prostate cancer screening.",2020,"After the 2 months intervention, the pretest-posttest changes in the intervention group compared to the control group were in the Knowledge 9.26 ± 3.5 vs. 0.03 ± 1.68, Attitude 11.46 ± 3.5 vs. -0.16 ± 1.39, Subjective norms 3.16 ± 2.6 vs. 0.29 ± 1.3, Behavioral control 6.76 ± 4 vs. 0.12 ± 1.60 and Behavioral intention 1.4 ± 1.54 vs. 0.00 ± 1.00 ( P  < 0.05).","['Prostate Cancer Screening', '68 middle-aged men referring to community houses in Iran', 'early diagnosis of prostate cancer']","['Educational Program', 'educational program based on the Theory of Planned Behavior (TPB']","['demographic characteristics, knowledge and construct of TPB (Attitude towards the behavior, Subjective norms, Perceived behavioral control, behavioral intention) and behavior']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",68.0,0.0271699,"After the 2 months intervention, the pretest-posttest changes in the intervention group compared to the control group were in the Knowledge 9.26 ± 3.5 vs. 0.03 ± 1.68, Attitude 11.46 ± 3.5 vs. -0.16 ± 1.39, Subjective norms 3.16 ± 2.6 vs. 0.29 ± 1.3, Behavioral control 6.76 ± 4 vs. 0.12 ± 1.60 and Behavioral intention 1.4 ± 1.54 vs. 0.00 ± 1.00 ( P  < 0.05).","[{'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Rezaei', 'Affiliation': 'Department of Community Health and Geriatric Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Negarandeh', 'Affiliation': 'Department of Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Pasheypoor', 'Affiliation': 'Department of Community Health and Geriatric Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anoshirvan', 'Initials': 'A', 'LastName': 'Kazemnejad', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}]",International journal of preventive medicine,['10.4103/ijpvm.IJPVM_137_19']
2315,33209396,On-pump versus off-pump coronary artery bypass surgery for multi-vessel coronary revascularization.,"Background


This study aims to compare the operative and postoperative results of on-pump (ONCAB) and off-pump (OPCAB) coronary artery bypass surgery (CABG) for multi-vessel coronary revascularization (≥4 anastomoses).
Methods


From May 2018 to August 2019, a total of 120 patients (22.5% women, mean age 61.5±8.4 years) received either ONCAB (Group 1, n=60) or OPCAB (Group 2, n=60) for multi-vessel coronary artery disease (CAD). Preoperative left ventricular (LV) ejection fraction (EF) was 53.1%±8.4%. Median EuroSCORE II was 1.59 (interquartile range, 1.01-2.54). The median number of performed coronary anastomoses was 4 (interquartile range, 4-5), with equal distribution in both groups (P=0.4). All procedures were performed by highly experienced surgeons. The primary endpoints were overall survival at 30 days and freedom from severe adverse events (SAE), which included myocardial infarction (MI), coronary artery re-operation, and re-thoracotomy, caused by bleeding and stroke.
Results


The overall survival in both groups was 100% with no intraoperative OPCAB-to-on-pump conversion. The median procedure time was 169 min (interquartile range, 150-179 min) for Group 1 and 183 min (interquartile range, 169-205 min) for Group 2 (P<0.001). The overall freedom from SAE numbered 93.3% (98.3%  vs.  88.3%, P=0.030). Postoperative MI rate was 2.5% (n=3) with no significant difference for either group (0  vs.  5.0%, P=0.100). One MI patient underwent a re-operation, and two other patients received a conservative treatment. A total of 2.5% (n=3) of patients underwent a re-thoracotomy on account of bleeding (0  vs.  5.0%, P=0.100); no anastomosis-related bleeding was detected. Blood transfusion was applied in 31.7% of patients (38.3%  vs.  25.0%, P=0.090). A total of 1.7% of patients (1.7%  vs.  1.7%, P=0.800) developed a stroke. Ventilation time, intensive care unit stay, and hospital stay were similar in both groups.
Conclusions


ONCAB showed superior freedom from SAE and shorter procedure times when compared to OPCAB for multi-vessel coronary artery revascularization.",2020,"The primary endpoints were overall survival at 30 days and freedom from severe adverse events (SAE), which included myocardial infarction (MI), coronary artery re-operation, and re-thoracotomy, caused by bleeding and stroke.
","['Methods\n\n\nFrom May 2018 to August 2019, a total of 120 patients (22.5% women, mean age 61.5±8.4 years']","['ONCAB', 'conservative treatment', 'pump versus off-pump coronary artery bypass surgery', 'pump (ONCAB) and off-pump (OPCAB) coronary artery bypass surgery (CABG', 'OPCAB']","['median number of performed coronary anastomoses', 'Median EuroSCORE II', 'Postoperative MI rate', 'median procedure time', 'Preoperative left ventricular (LV) ejection fraction (EF', 'overall survival at 30 days and freedom from severe adverse events (SAE), which included myocardial infarction (MI), coronary artery re-operation, and re-thoracotomy, caused by bleeding and stroke', 'no anastomosis-related bleeding', 'Ventilation time, intensive care unit stay, and hospital stay', 'account of bleeding', 'Blood transfusion', 'overall survival']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0589368', 'cui_str': 'Postoperative myocardial infarction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",120.0,0.0976415,"The primary endpoints were overall survival at 30 days and freedom from severe adverse events (SAE), which included myocardial infarction (MI), coronary artery re-operation, and re-thoracotomy, caused by bleeding and stroke.
","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Zubarevich', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Bakytbek', 'Initials': 'B', 'LastName': 'Kadyraliev', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Vagram', 'Initials': 'V', 'LastName': 'Arutyunyan', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Vahe', 'Initials': 'V', 'LastName': 'Chragyan', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Magomedganipa', 'Initials': 'M', 'LastName': 'Askadinov', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Sozkov', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Danil', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Zyazeva', 'Affiliation': 'Department of Cardiovascular Surgery, S.G. Sukhanov Federal Center of Cardiovascular Surgery, E.A. Vagner Perm State Medical University, Perm, Russian Federation.'}, {'ForeName': 'Michel Pompeu Barros', 'Initials': 'MPB', 'LastName': 'Oliveira Sá', 'Affiliation': 'Division of Cardiovascular Surgery of Pronto Socorro Cardiológico de Pernambuco-PROCAPE, University of Pernambuco, Recife, Brazil.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Osswald', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsagakis', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendt', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Arjang', 'Initials': 'A', 'LastName': 'Ruhparwar', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weymann', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Zhigalov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany.'}]",Journal of thoracic disease,['10.21037/jtd-20-1284']
2316,33209701,"Comment on: Safety and efficacy of mirabegron: analysis of a large integrated clinical trial database of patients with overactive bladder receiving mirabegron, antimuscarinics, or placebo.",,2020,,"['patients with overactive bladder receiving mirabegron, antimuscarinics, or']","['mirabegron', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.140594,,"[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Scandura', 'Affiliation': 'Urology Section, University of Catania, Catania, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Morgia', 'Affiliation': 'Urology Section, University of Catania, Catania, Italy.'}, {'ForeName': 'Giorgio Ivan', 'Initials': 'GI', 'LastName': 'Russo', 'Affiliation': 'Urology Section, University of Catania, Catania, Italy.'}]",Translational andrology and urology,['10.21037/tau-20-876']
2317,33209727,Application of vocal organ correction combined with language training in the rehabilitation of children with cerebral palsy and language disorder.,"Background


To explore the effect of vocal organ correction combined with language training on the rehabilitation of children with cerebral palsy (CP) and language disorder.
Methods


A total of 98 children with CP and language disorder were divided into two groups (49 cases in each group) using a random number table: the control group and the test group. The control group was given language training alone, while the test group received vocal organ correction combined with language training. The changes in language function classification, efficacy, and family satisfaction before and after the treatments were compared.
Results


A significant difference was identified in language function classification between the two groups before and after treatment (P<0.05). The language function classification of the two groups was also significantly different after treatment (P<0.05), as was the distribution of clinical efficacy between the two groups (P<0.05). The total effective rate for the test group was 91.84%, which was higher than the 73.47% for the control group (P<0.05). Family satisfaction between the two groups differed significantly (P<0.05), and the total satisfaction rate of families in the test group was 87.76%, which was higher than the 69.39% in the control group (P<0.05).
Conclusions


Vocal organ correction combined with language training can improve the language function of children with CP and language disorder, has ideal efficacy, and can also enhance family satisfaction during rehabilitation.",2020,"Family satisfaction between the two groups differed significantly (P<0.05), and the total satisfaction rate of families in the test group was 87.76%, which was higher than the 69.39% in the control group (P<0.05).
","['children with cerebral palsy (CP) and language disorder', '98 children with CP and language disorder', 'children with cerebral palsy and language disorder', 'children with CP and language disorder']","['language training', 'language training alone, while the test group received vocal organ correction combined with language training', 'vocal organ correction combined with language training']","['language function classification', 'total effective rate', 'clinical efficacy', 'language function classification, efficacy, and family satisfaction', 'language function', 'total satisfaction rate of families', 'Family satisfaction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0023015', 'cui_str': 'Disorder of language'}]","[{'cui': 'C0023018', 'cui_str': 'Language Training'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",98.0,0.0185923,"Family satisfaction between the two groups differed significantly (P<0.05), and the total satisfaction rate of families in the test group was 87.76%, which was higher than the 69.39% in the control group (P<0.05).
","[{'ForeName': 'Jinjun', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': 'Department of Paediatrics, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Youfang', 'Initials': 'Y', 'LastName': 'Mo', 'Affiliation': 'Department of Rehabilitation, Tongde Hospital of Zhejiang Province, Hangzhou, China.'}]",Translational pediatrics,['10.21037/tp-20-223']
2318,33095526,Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.,"BACKGROUND


The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.
METHODS


We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.
RESULTS


A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P = 0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events.
CONCLUSIONS


Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).",2020,"Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03).","['pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth', 'women in low-resource countries who were at risk for early preterm birth', 'women in low-resource countries who are at risk for preterm birth', 'Early Preterm Birth in Low-Resource Countries', '2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization']","['Antenatal Dexamethasone', 'dexamethasone or identical placebo', 'dexamethasone', 'placebo', 'antenatal glucocorticoids']","['neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection', 'Neonatal death', 'risks of neonatal death alone and stillbirth or neonatal death', 'incidence of possible maternal bacterial infection', 'Stillbirth or neonatal death', 'incidence of adverse events']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2852.0,0.544249,"Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P = 0.03).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Olufemi T', 'Initials': 'OT', 'LastName': 'Oladapo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Joshua P', 'Initials': 'JP', 'LastName': 'Vogel', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Piaggio', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'My-Huong', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'A Metin', 'Initials': 'AM', 'LastName': 'Gülmezoglu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Suman P N', 'Initials': 'SPN', 'LastName': 'Rao', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'De Costa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shuchita', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Abdullah H', 'Initials': 'AH', 'LastName': 'Baqui', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rasheda', 'Initials': 'R', 'LastName': 'Khanam', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mohammod', 'Initials': 'M', 'LastName': 'Shahidullah', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saleha B', 'Initials': 'SB', 'LastName': 'Chowdhury', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Salahuddin', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nazma', 'Initials': 'N', 'LastName': 'Begum', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Arunangshu', 'Initials': 'A', 'LastName': 'D Roy', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Shahed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Iffat A', 'Initials': 'IA', 'LastName': 'Jaben', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Farida', 'Initials': 'F', 'LastName': 'Yasmin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M Mozibur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Anjuman', 'Initials': 'A', 'LastName': 'Ara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Soofia', 'Initials': 'S', 'LastName': 'Khatoon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Gulshan', 'Initials': 'G', 'LastName': 'Ara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Akter', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Akhter', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Probhat R', 'Initials': 'PR', 'LastName': 'Dey', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M Abdus', 'Initials': 'MA', 'LastName': 'Sabur', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mohammad T', 'Initials': 'MT', 'LastName': 'Azad', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shahana F', 'Initials': 'SF', 'LastName': 'Choudhury', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Matin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mrityunjay C', 'Initials': 'MC', 'LastName': 'Metgud', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Yeshita V', 'Initials': 'YV', 'LastName': 'Pujar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Manjunath S', 'Initials': 'MS', 'LastName': 'Somannavar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Vernekar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Veena R', 'Initials': 'VR', 'LastName': 'Herekar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shailaja R', 'Initials': 'SR', 'LastName': 'Bidri', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sangamesh S', 'Initials': 'SS', 'LastName': 'Mathapati', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Preeti G', 'Initials': 'PG', 'LastName': 'Patil', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Mallanagouda M', 'Initials': 'MM', 'LastName': 'Patil', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Muttappa R', 'Initials': 'MR', 'LastName': 'Gudadinni', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hidaytullah R', 'Initials': 'HR', 'LastName': 'Bijapure', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sumangala B', 'Initials': 'SB', 'LastName': 'Chikkamath', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bhuvaneshwari C', 'Initials': 'BC', 'LastName': 'Yelamali', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ramesh R', 'Initials': 'RR', 'LastName': 'Pol', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sujata S', 'Initials': 'SS', 'LastName': 'Misra', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Das', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Nanda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rashmita B', 'Initials': 'RB', 'LastName': 'Nayak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bipsa', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Zahida', 'Initials': 'Z', 'LastName': 'Qureshi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Fredrick', 'Initials': 'F', 'LastName': 'Were', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Osoti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Gwako', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Laving', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hafsa', 'Initials': 'H', 'LastName': 'Mohamed', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Nawal', 'Initials': 'N', 'LastName': 'Aliyan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adelaide', 'Initials': 'A', 'LastName': 'Barassa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kibaru', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Mbuga', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Thuranira', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Njoroge J', 'Initials': 'NJ', 'LastName': 'Githua', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bernadine', 'Initials': 'B', 'LastName': 'Lusweti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adejumoke I', 'Initials': 'AI', 'LastName': 'Ayede', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adegoke G', 'Initials': 'AG', 'LastName': 'Falade', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olubukola A', 'Initials': 'OA', 'LastName': 'Adesina', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Atinuke M', 'Initials': 'AM', 'LastName': 'Agunloye', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Oluwatosin O', 'Initials': 'OO', 'LastName': 'Iyiola', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Sanni', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ifeyinwa K', 'Initials': 'IK', 'LastName': 'Ejinkeonye', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hadiza A', 'Initials': 'HA', 'LastName': 'Idris', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Chinyere V', 'Initials': 'CV', 'LastName': 'Okoli', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Irinyenikan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Omolayo A', 'Initials': 'OA', 'LastName': 'Olubosede', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olaseinde', 'Initials': 'O', 'LastName': 'Bello', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olufemi M', 'Initials': 'OM', 'LastName': 'Omololu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olanike A', 'Initials': 'OA', 'LastName': 'Olutekunbi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adesina L', 'Initials': 'AL', 'LastName': 'Akintan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olorunfemi O', 'Initials': 'OO', 'LastName': 'Owa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Rosena O', 'Initials': 'RO', 'LastName': 'Oluwafemi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ireti P', 'Initials': 'IP', 'LastName': 'Eniowo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adetokunbo O', 'Initials': 'AO', 'LastName': 'Fabamwo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Disu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Joy O', 'Initials': 'JO', 'LastName': 'Agbara', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ebunoluwa A', 'Initials': 'EA', 'LastName': 'Adejuyigbe', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Oluwafemi', 'Initials': 'O', 'LastName': 'Kuti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Anyabolu', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ibraheem O', 'Initials': 'IO', 'LastName': 'Awowole', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Akintunde O', 'Initials': 'AO', 'LastName': 'Fehintola', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Bankole P', 'Initials': 'BP', 'LastName': 'Kuti', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Isah', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Eyinade K', 'Initials': 'EK', 'LastName': 'Olateju', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olusanya', 'Initials': 'O', 'LastName': 'Abiodun', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Olabisi F', 'Initials': 'OF', 'LastName': 'Dedeke', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Akinkunmi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lawal', 'Initials': 'L', 'LastName': 'Oyeneyin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Omotayo', 'Initials': 'O', 'LastName': 'Adesiyun', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hadijat O', 'Initials': 'HO', 'LastName': 'Raji', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Adedapo B A', 'Initials': 'ABA', 'LastName': 'Ande', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Ikechukwu', 'Initials': 'I', 'LastName': 'Okonkwo', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sajid B', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Lumaan', 'Initials': 'L', 'LastName': 'Sheikh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Zulfiqar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Omer', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Raheel', 'Initials': 'R', 'LastName': 'Sikandar', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Giordano', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gamerro', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Carroli', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neilson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Molyneux', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Yunis', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Kidza', 'Initials': 'K', 'LastName': 'Mugerwa', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}, {'ForeName': 'Harish K', 'Initials': 'HK', 'LastName': 'Chellani', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022398']
2319,33204666,"A Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Clinical Study to Evaluate the Efficacy and Safety of  Artemisia annua  L. Extract for Improvement of Liver Function.","Non-alcoholic fatty liver disease (NAFLD) has the potential to develop into hepatic steatosis and progress to terminal liver diseases such as cirrhosis and hepatocellular carcinoma. This human clinical study was aimed to demonstrate that SPB-201 (powdered-water extract of  Artemisia annua ) can improve liver function in subjects with non-alcoholic liver dysfunction at mild to moderate levels. A decrease of 271% in aspartate aminotransferase (AST) level and a significant decrease of 334% in alanine aminotransferase (ALT) level was observed in the test group as compared to the control group at the 4 weeks follow-up. In addition, after 8 weeks, decreases of 199% in AST level and 216% in ALT level were reported in the test group as compared to the control group. These results confirmed that SPB-201 intake significantly enhanced liver function and health. Moreover, the Multidimensional Fatigue Scale score of the test group decreased but that of the control group increased, implicating that SPB-201 also eliminated overall fatigue. No significant adverse events were observed among all subjects during the study. Taken together, our clinical study confirmed the excellent efficacy and safety of SPB-201 in liver function improvement, showing the possibility of SPB-201 as a functional food to restore liver dysfunction and treat liver diseases.",2020,A decrease of 271% in aspartate aminotransferase (AST) level and a significant decrease of 334% in alanine aminotransferase (ALT) level was observed in the test group as compared to the control group at the 4 weeks follow-up.,['subjects with non-alcoholic liver dysfunction at mild to moderate levels'],"['Placebo', 'SPB-201 (powdered-water extract of  Artemisia annua ']","['alanine aminotransferase (ALT) level', 'Multidimensional Fatigue Scale score', 'liver function', 'liver function and health', 'aspartate aminotransferase (AST) level', 'overall fatigue', 'Efficacy and Safety of', 'adverse events', 'Liver Function']","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597729', 'cui_str': 'Spindle Pole Body'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0686899', 'cui_str': 'Artemisia annua'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0277513,A decrease of 271% in aspartate aminotransferase (AST) level and a significant decrease of 334% in alanine aminotransferase (ALT) level was observed in the test group as compared to the control group at the 4 weeks follow-up.,"[{'ForeName': 'Byoungduck', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Family Medicine, Sahmyook Medical Center, Seoul 02500, Korea.'}, {'ForeName': 'Seon-Mee', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Family Medicine, Korea University Guro Hospital, Seoul 08308, Korea.'}, {'ForeName': 'Ga Eun', 'Initials': 'GE', 'LastName': 'Nam', 'Affiliation': 'Department of Family Medicine, Korea University Anam Hospital, Seoul 02841, Korea.'}, {'ForeName': 'Seon-Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Sungkyun Biotech, Co., Ltd., Suwon 16648, Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'G&P Bioscience Co. LTD., Goyang 10326, Korea.'}, {'ForeName': 'Young-Kyu', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Bundang Jesaeng Hospital, Seongnam 13590, Korea.'}, {'ForeName': 'Hyun Wook', 'Initials': 'HW', 'LastName': 'Baik', 'Affiliation': 'Division of Gastroenterology & Clinical Nutrition, Department of Internal Medicine, DMC Bundang Jesaeng Hospital, Seongnam 13590, Korea.'}]",Clinical nutrition research,['10.7762/cnr.2020.9.4.258']
2320,33204668,Effect of Selenium Supplementation on Expression of SIRT1 and PGC-1α Genes in Ulcerative Colitis Patients: a Double Blind Randomized Clinical Trial.,"Selenium (Se) supplementation may decrease the severity of ulcerative colitis (UC) through the activation of genes responsible for immune modulation. The present research was aimed to assess the effect of Se supplementation on the expression of silent information regulator 1 (SIRT1) and peroxisome proliferator-activated receptor γ coactivator-1α (PGC-1α) in UC patients. In a double-blind randomized parallel clinical trial, 100 patients with mild-to-moderate active UC met inclusion criteria and divided into 2 groups of treatment (50 patients received selenomethionine [200 µg daily]) and placebo (50 patients received placebo [1 capsule daily]) for 10 weeks. The expression rates of SIRT1 and PGC-1α were examined in the peripheral blood mononuclear cell (PBMC) using the real-time polymerase chain reaction. There was no considerable difference in the mean of baseline demographic and clinical characteristics between groups. Also, there were no significant differences in total energy intake, macronutrients, and micronutrients between groups. The SIRT1 gene expression in the Se group was significantly increased compared to the placebo (p < 0.001). An increase in the expression of the PGC-1α gene in the Se group was not statistically significant. It seems that Se supplementation caused a significant decrease in the inflammatory response of the colon by a significant increase in the expression of the SIRT1 gene.",2020,The SIRT1 gene expression in the Se group was significantly increased compared to the placebo (p < 0.001).,"['100 patients with mild-to-moderate active UC met inclusion criteria and divided into 2 groups of treatment (50 patients received', 'Ulcerative Colitis Patients', 'UC patients']","['Selenium (Se) supplementation', 'placebo', 'Selenium Supplementation', 'selenomethionine [200 µg daily]) and placebo']","['SIRT1 gene expression', 'inflammatory response', 'total energy intake, macronutrients, and micronutrients', 'severity of ulcerative colitis (UC', 'Expression of SIRT1 and PGC-1α Genes', 'expression rates of SIRT1 and PGC-1α', 'expression of the PGC-1α gene']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034616', 'cui_str': 'Selenomethionine Se 75'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",100.0,0.201229,The SIRT1 gene expression in the Se group was significantly increased compared to the placebo (p < 0.001).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khazdouz', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran 14665-354, Iran.'}, {'ForeName': 'Naser Ebrahimi', 'Initials': 'NE', 'LastName': 'Daryani', 'Affiliation': 'Division of Gastroenterology, Imam Khomeini Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran 14167-53955, Iran.'}, {'ForeName': 'Foroogh', 'Initials': 'F', 'LastName': 'Alborzi', 'Affiliation': 'Division of Gastroenterology, Imam Khomeini Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran 14167-53955, Iran.'}, {'ForeName': 'Mir Hadi', 'Initials': 'MH', 'LastName': 'Jazayeri', 'Affiliation': 'Department of Immunology, School of Medicine, Immunology Research Center, Iran University of Medical Sciences, Tehran 14665-354, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Farsi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran 14665-354, Iran.'}, {'ForeName': 'Motahareh', 'Initials': 'M', 'LastName': 'Hasani', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran 14665-354, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Heshmati', 'Affiliation': 'Department of Nutritional Science, School of Nutritional Science and Food Technology, Kermanshah University of Medical Sciences, Kermanshah 67155-1616, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran 14665-354, Iran.'}]",Clinical nutrition research,['10.7762/cnr.2020.9.4.284']
2321,33204679,"Proximate, Antinutritional, Microbial, and Sensory Acceptability of Bread Formulated from Wheat ( Triticum aestivum ) and Amaranth ( Amaranthus caudatus ).","Background


Breads are made throughout the world. Bread can be prepared from cereal like wheat, maize, and rice. Nowadays, gluten intolerance, requirement of healthy, and nutritious products have increased and interests towards underutilized crops have also been increasing with the aim of improving global food security and to ease an adverse effect of climate changes. Amaranth is one of nutritionally balanced and naturally grown underutilized crops, but it is mainly considered weed in Africa including Ethiopia.
Method


The aim of the study is to develop bread from wheat and Amaranthus and to evaluate proximate composition, antinutritional, microbial, and sensory acceptability of bread. The experiment contained 100% wheat as control and four blending proportions (90% wheat and 10% amaranth, 80% wheat and 20% amaranth, 70% wheat and 30% amaranth, and 60% wheat and 40% amaranth). A complete randomized design is used for proximate composition, antinutritional, and microbial data analysis whereas a randomized complete block design with three replications was applied for sensory acceptability. SAS for windows version 9 was used for data analysis.
Result


The study revealed that moisture, protein, fat, fiber, and antinutritional content were increased as Amaranthus concentration is increased from 10% to 40%. However, carbohydrate, microbial load, and sensory acceptability were decreased. But the gross energy is constant.
Conclusion


From the study, it can be concluded that beside the good nutritional profile of Amaranthus, it has antinutritional content which needs to limit the concentration of Amaranthus in blending with other grains during product development.",2020,"However, carbohydrate, microbial load, and sensory acceptability were decreased.",[],[],"['Proximate, Antinutritional, Microbial, and Sensory Acceptability', 'carbohydrate, microbial load, and sensory acceptability', 'Amaranthus concentration', 'moisture, protein, fat, fiber, and antinutritional content', 'proximate composition, antinutritional, microbial, and sensory acceptability of bread']",[],[],"[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0330370', 'cui_str': 'Amaranthus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0006138', 'cui_str': 'Bread'}]",,0.0279403,"However, carbohydrate, microbial load, and sensory acceptability were decreased.","[{'ForeName': 'Aemiro Tadesse', 'Initials': 'AT', 'LastName': 'Zula', 'Affiliation': 'School of Nutrition, Food Science and Technology, Center of Excelence in Human Nutrition, Hawassa University, Ethiopia.'}, {'ForeName': 'Dagim Alemayehu', 'Initials': 'DA', 'LastName': 'Ayele', 'Affiliation': 'School of Nutrition, Food Science and Technology, Center of Excelence in Human Nutrition, Hawassa University, Ethiopia.'}, {'ForeName': 'Woinshet Abera', 'Initials': 'WA', 'LastName': 'Egigayhu', 'Affiliation': 'Center of Food Science and Nutrition, Addis Ababa University, Ethiopia.'}]",International journal of food science,['10.1155/2020/9429584']
2322,33204721,A Nomogram Model Based on Noninvasive Bioindicators to Predict 3-Year Risk of Nonalcoholic Fatty Liver in Nonobese Mainland Chinese: A Prospective Cohort Study.,"The purpose of this study is to establish and validate an accurate and personalized nonalcoholic fatty liver disease (NAFLD) prediction model based on the nonobese population in China. This study is a secondary analysis of a prospective study. We included 6,155 nonobese adults without NAFLD at baseline, with a median follow-up of 2.3 years. Univariate and multivariate Cox regression analyses were used to determine independent predictors. The least absolute shrinkage and selection operator (LASSO) regression analysis was used to optimize the selection of variables. Based on the results of multivariate analysis, a prediction model was established. Harrell's consistency index (C-index) and area under the curve (AUC) were used to determine the discrimination of the proposed model. The goodness of fit of the calibration model was tested, and the clinical application value of the model was evaluated by decision curve analysis (DCA). The participants were randomly divided into a training cohort ( n  = 4,605) and a validation cohort ( n  = 1,550). Finally, seven of the variables (HDL-c, BMI, GGT, ALT, TB, DBIL, and TG) were included in the prediction model. In the training cohort, the C-index and AUC value of this prediction model were 0.832 (95% confidence interval (CI), 0.820-0.844) and 0.861 (95% CI, 0.849-0.873), respectively. In the validation cohort, the C-index and AUC values of this prediction model were 0.829 (95% CI, 0.806-0.852) and 0.859 (95% CI, 0.841-0.877), respectively. The calibration plots demonstrated good agreement between the estimated probability and the actual observation. DCA demonstrated a clinically effective predictive model. Our nomogram can be used as a simple, reasonable, economical, and widely used tool to predict the 3-year risk of NAFLD in nonobese populations in China, which is helpful for timely intervention and reducing the incidence of NAFLD.",2020,"In the validation cohort, the C-index and AUC values of this prediction model were 0.829 (95% CI, 0.806-0.852) and 0.859 (95% CI, 0.841-0.877), respectively.","['Nonobese Mainland Chinese', 'nonobese population in China', '6,155 nonobese adults without NAFLD at baseline, with a median follow-up of 2.3 years']",['DCA'],"['variables (HDL-c, BMI, GGT, ALT, TB, DBIL, and TG', ""Harrell's consistency index (C-index) and area under the curve (AUC""]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",6155.0,0.0261277,"In the validation cohort, the C-index and AUC values of this prediction model were 0.829 (95% CI, 0.806-0.852) and 0.859 (95% CI, 0.841-0.877), respectively.","[{'ForeName': 'Xintian', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}, {'ForeName': 'Xiayire', 'Initials': 'X', 'LastName': 'Aierken', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}, {'ForeName': 'Ayguzal', 'Initials': 'A', 'LastName': 'Ahmat', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}, {'ForeName': 'Nanfang', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ""Hypertension Center of People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hypertension Institute, National Health Committee Key Laboratory of Hypertension Clinical Research, Urumqi, China.""}]",BioMed research international,['10.1155/2020/8852198']
2323,33205852,Efficacy of transcutaneous posterior tibial nerve stimulation in children with functional voiding disorders.,"AIMS


To assess the efficacy of transcutaneous posterior tibial nerve stimulation (TPTNS) on functional voiding disorder (FVD) and investigate the utility of urine biomarkers (UBs: nerve growth factor, transforming growth factor-beta 1, and tissue inhibitor of metalloproteinases 2) in diagnosis and follow-up.
METHODS


A total of 44 children were included to this randomized controlled trial prospectively. After randomization, 20 of 30 children with storage phase dysfunction those were unresponsive or noncompliant to medical treatment received TPTNS treatment (test group) and 10 children underwent TPTNS with no current (sham group) for 12 weeks. Fourteen healthy children constituted the nonsymptomatic group. UB levels, dysfunctional voiding and incontinence scoring system (DVISS), voiding diary, and quality of life (QoL) scores were assessed before and after treatment in the treatment groups.
RESULTS


QoL scores, overall and day-time DVISS scores were significantly decreased in both sham and test groups (p < 0.05). In addition to these findings, the frequency of incontinence and urgency episodes were also significantly reduced (p < 0.05) in the TPTNS treatment group. This effect in the test group was still valid 2 years after intervention. There was no significant difference in UBs measurements between treatment and nonsymptomatic groups and between pretreatment and posttreatment measurements of test and sham groups.
CONCLUSIONS


TPTNS is an efficient minimally invasive treatment in children with FVD who do not respond to medical treatment. TPTNS provides a significant improvement on episodes of frequency, episodes of incontinence, overall and day-time DVISS scores, and QoL scores. The effectiveness of treatment continues even at the end of the second year of intervention. UBs were not found to be predictive in terms of diagnosis and evaluating the treatment response.",2020,"There was no significant difference in UBs measurements between treatment and nonsymptomatic groups and between pretreatment and posttreatment measurements of test and sham groups.
","['Fourteen healthy children constituted the nonsymptomatic group', '44 children', 'children with functional voiding disorders', '30 children with storage phase dysfunction those were unresponsive or noncompliant to medical treatment received', 'children with FVD who do not respond to medical treatment']","['transcutaneous posterior tibial nerve stimulation (TPTNS', 'transcutaneous posterior tibial nerve stimulation', 'TPTNS treatment', 'TPTNS with no current']","['QoL scores, overall\xa0and day-time DVISS scores', 'UB levels, dysfunctional voiding and incontinence scoring system (DVISS), voiding diary, and quality of life (QoL) scores', 'UBs measurements', 'functional voiding disorder (FVD', 'frequency of incontinence and urgency episodes', 'episodes of frequency, episodes of incontinence, overall and day-time DVISS scores, and QoL scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403641', 'cui_str': 'Functional disorder of bladder'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C0403659', 'cui_str': 'Dysfunctional voiding'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0403641', 'cui_str': 'Functional disorder of bladder'}, {'cui': 'C0426369', 'cui_str': 'Frequency of incontinence'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",44.0,0.04016,"There was no significant difference in UBs measurements between treatment and nonsymptomatic groups and between pretreatment and posttreatment measurements of test and sham groups.
","[{'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Jafarov', 'Affiliation': 'Department of Urology,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Erman', 'Initials': 'E', 'LastName': 'Ceyhan', 'Affiliation': 'Department of Urology,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Oguzhan', 'Initials': 'O', 'LastName': 'Kahraman', 'Affiliation': 'Department of Urology,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Taner', 'Initials': 'T', 'LastName': 'Ceylan', 'Affiliation': 'Department of Urology, Division of Pediatric Urology,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Zeliha G', 'Initials': 'ZG', 'LastName': 'Dikmen', 'Affiliation': 'Department of Medical Biochemistry,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Tekgul', 'Affiliation': 'Department of Urology, Division of Pediatric Urology,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hasan S', 'Initials': 'HS', 'LastName': 'Dogan', 'Affiliation': 'Department of Urology, Division of Pediatric Urology,\xa0Faculty of Medicine, Hacettepe University, Ankara, Turkey.'}]",Neurourology and urodynamics,['10.1002/nau.24575']
2324,33205898,Transcranial direct-current stimulation enhances implicit motor sequence learning in persons with Parkinson's disease with mild cognitive impairment.,"Implicit motor sequence learning (IMSL) is affected in Parkinson's disease (PD). Research in healthy young participants shows the potential for transcranial direct-current stimulation (tDCS) over the primary motor cortex (M1) to enhance IMSL. In PD, only null effects have been reported to date. We determined concurrent, short-term, and long-term effects of anodal tDCS over M1 on IMSL, as measured by the serial reaction time (SRT) task, in persons with PD with mild cognitive impairment (MCI). Concurrent (anodal/sham tDCS intervention during the SRT task), short-term (5 min post-intervention), and long-term (1 week post-intervention) effects on IMSL were evaluated in persons with idiopathic PD (Hoehn and Yahr stage II-III) with MCI. Results of 11 persons with PD (8 men and 3 women; mean age = 77.1 years; mean disease duration = 7.7 years) showed significant IMSL in the anodal (p = .016), but not in the sham tDCS condition (p = .937). Post-hoc analyses showed that IMSL reached statistical significance at 1 week post-intervention (p < .001). Anodal tDCS over M1 exerted beneficial effects on IMSL in persons with PD with MCI, in particular one week post-intervention. Our study is the first to report a positive effect of tDCS on IMSL in PD. Further research should include a larger, more cognitively diverse sample and additional follow-up periods.",2020,Post-hoc analyses showed that IMSL reached statistical significance at 1 week post-intervention (p < .001).,"[""Parkinson's disease (PD"", ""persons with Parkinson's disease with mild cognitive impairment"", 'persons with idiopathic PD (Hoehn and Yahr stage II-III) with MCI', '11 persons with PD (8 men and 3 women; mean age\xa0', 'persons with PD with mild cognitive impairment (MCI', 'healthy young participants']","['Concurrent (anodal/sham tDCS intervention', 'Transcranial direct-current stimulation enhances implicit motor sequence learning', 'Implicit motor sequence learning (IMSL', 'transcranial direct-current stimulation (tDCS', 'tDCS']","['serial reaction time (SRT) task', 'IMSL']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",11.0,0.0133385,Post-hoc analyses showed that IMSL reached statistical significance at 1 week post-intervention (p < .001).,"[{'ForeName': 'Mahyar', 'Initials': 'M', 'LastName': 'Firouzi', 'Affiliation': 'Brain, Body and Cognition, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Karlijn', 'Initials': 'K', 'LastName': 'Van Herk', 'Affiliation': 'Rehabilitation Research, Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kerckhofs', 'Affiliation': 'Brain, Body and Cognition, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Swinnen', 'Affiliation': 'Rehabilitation Research, Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Brain, Body and Cognition, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Van Overwalle', 'Affiliation': 'Brain, Body and Cognition, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Belgium.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Deroost', 'Affiliation': 'Brain, Body and Cognition, Department of Psychology and Educational Sciences, Vrije Universiteit Brussel, Belgium.'}]",Journal of neuropsychology,['10.1111/jnp.12231']
2325,33205906,"Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission on Combination Therapy: A Randomized, Double-Blind Trial.","OBJECTIVE


Patients with rheumatoid arthritis (RA) achieving remission on methotrexate plus etanercept therapy (Combo) face ongoing medication burden. Whether those in sustained remission on Combo can maintain remission with monotherapy (mono) after discontinuing either methotrexate or etanercept has not been adequately tested.
METHODS


Adult RA patients on Combo (N=371) maintaining Simplified Disease Activity Index (SDAI) remission through a 24-week open-label period (N=253) entered a 48-week, double-blind period and were randomized to: (1) methotrexate-mono (N=101); (2) etanercept-mono (N=101); or (3) Combo (N=51). Patients with disease-worsening received Combo rescue therapy at prior dosages. The primary endpoint was the proportion of patients in SDAI remission without disease-worsening at week 48 in the etanercept-mono vs methotrexate-mono arms. Secondary endpoints included time to disease-worsening and proportion of patients recapturing SDAI remission after rescue therapy.
RESULTS


Baseline characteristics were similar across treatment arms. At week 48, SDAI remission was maintained by significantly more patients on etanercept-mono vs methotrexate-mono (49.5% vs 28.7%; P=0.004) and by more patients on Combo vs methotrexate-mono (52.9% vs 28.7%; P=0.006; secondary endpoint). Time to disease-worsening was shorter with methotrexate-mono compared with etanercept-mono and Combo (P<0.001 for both comparisons). Among patients receiving rescue therapy, 70-80% in each arm recaptured SDAI remission. No new safety signals were reported.
CONCLUSIONS


Etanercept-mono was superior to methotrexate-mono and similar to Combo in maintaining remission during the double-blind phase. Most patients on rescue therapy recaptured remission. These data inform decision-making around withdrawing therapy to reduce treatment burden in well-controlled RA.",2020,Etanercept-mono was superior to methotrexate-mono and similar to Combo in maintaining remission during the double-blind phase.,"['Rheumatoid Arthritis Patients in Sustained Remission on Combination Therapy', 'Adult RA patients on Combo (N=371) maintaining Simplified Disease Activity Index (SDAI) remission through a 24-week open-label period (N=253', 'patients receiving rescue therapy, 70-80% in each arm recaptured SDAI remission', 'Patients with rheumatoid arthritis (RA', 'Patients with disease-worsening received']","['Combo rescue therapy', 'Etanercept or Methotrexate Withdrawal', 'Etanercept-mono was superior to methotrexate-mono and similar to Combo', 'methotrexate plus etanercept therapy (Combo', 'methotrexate or etanercept', 'methotrexate-mono (N=101); (2) etanercept-mono (N=101); or (3) Combo']","['SDAI remission', 'proportion of patients in SDAI remission without disease-worsening', 'time to disease-worsening and proportion of patients recapturing SDAI remission', 'Time to disease-worsening']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4075969', 'cui_str': 'Etanercept therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",371.0,0.195557,Etanercept-mono was superior to methotrexate-mono and similar to Combo in maintaining remission during the double-blind phase.,"[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds National Institute for Health Research, Biomedical Research Center at Leeds Teaching Hospitals Trust, LIRMM Leeds University, Leeds, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Karis', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Boulos', 'Initials': 'B', 'LastName': 'Haraoui', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Bykerk', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'Priscilla K', 'Initials': 'PK', 'LastName': 'Yen', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Kricorian', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Chung', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41589']
2326,33205991,Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers : A Randomized Controlled Trial.,"BACKGROUND


Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both.
OBJECTIVE


To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures.
DESIGN


Randomized controlled trial (DANMASK-19 [Danish Study to Assess Face Masks for the Protection Against COVID-19 Infection]). (ClinicalTrials.gov: NCT04337541).
SETTING


Denmark, April and May 2020.
PARTICIPANTS


Adults spending more than 3 hours per day outside the home without occupational mask use.
INTERVENTION


Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use.
MEASUREMENTS


The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses.
RESULTS


A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was -0.3 percentage point (95% CI, -1.2 to 0.4 percentage point;  P  = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23];  P  = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection.
LIMITATION


Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others.
CONCLUSION


The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection.
PRIMARY FUNDING SOURCE


The Salling Foundations.",2020,"The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use.","['3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study', 'Denmark, April and May 2020', 'Adults spending more than 3 hours per day outside the home without occupational mask use', 'Danish Mask Wearers ']","['Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use']","['SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis', 'PCR positivity', 'infection', 'SARS-CoV-2 infection rate']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580327', 'cui_str': 'Antibody studies'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",3030.0,0.130204,"The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use.","[{'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Johan Skov', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Daniel Emil Tadeusz', 'Initials': 'DET', 'LastName': 'Raaschou-Pedersen', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Buchwald', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (C.V., T.T., H.U.).'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Todsen', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (C.V., T.T., H.U.).'}, {'ForeName': 'Jakob Boesgaard', 'Initials': 'JB', 'LastName': 'Norsk', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Mia M', 'Initials': 'MM', 'LastName': 'Pries-Heje', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Christoffer Rasmus', 'Initials': 'CR', 'LastName': 'Vissing', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Pernille B', 'Initials': 'PB', 'LastName': 'Nielsen', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Ulrik C', 'Initials': 'UC', 'LastName': 'Winsløw', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Kamille', 'Initials': 'K', 'LastName': 'Fogh', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Hasselbalch', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Jonas H', 'Initials': 'JH', 'LastName': 'Kristensen', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ringgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (H.B., J.S.B., D.E.T., M.M.P., C.R.V., U.C.W., A.R.).'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Porsborg Andersen', 'Affiliation': 'Nordsjaellands Hospital, Hillerød, and Aalborg University Hospital, Aalborg, Denmark (M.P.A., C.T.).'}, {'ForeName': 'Nicole Bakkegård', 'Initials': 'NB', 'LastName': 'Goecke', 'Affiliation': 'Centre for Diagnostics, Technical University of Denmark, Kongens Lyngby, Denmark (N.B.G.).'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Trebbien', 'Affiliation': 'National Influenza Center, Statens Serum Institut, Copenhagen, Denmark (R.T.).'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Skovgaard', 'Affiliation': 'Technical University of Denmark, Kongens Lyngby, Denmark (K.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases, Amager and Hvidovre Hospital, Copenhagen University Hospital, Hvidovre, Denmark (T.B.).'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ullum', 'Affiliation': 'Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark (C.V., T.T., H.U.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Nordsjaellands Hospital, Hillerød, and Aalborg University Hospital, Aalborg, Denmark (M.P.A., C.T.).'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': 'Herlev & Gentofte Hospital, Copenhagen University Hospital, Herlev, Denmark (J.B.N., P.B.N., K.F., R.H., J.H.K., K.I.).'}]",Annals of internal medicine,['10.7326/M20-6817']
2327,33206194,Predictive Modeling for Perinatal Mortality in Resource-Limited Settings.,"Importance


The overwhelming majority of fetal and neonatal deaths occur in low- and middle-income countries. Fetal and neonatal risk assessment tools may be useful to predict the risk of death.
Objective


To develop risk prediction models for intrapartum stillbirth and neonatal death.
Design, Setting, and Participants


This cohort study used data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research population-based vital registry, including clinical sites in South Asia (India and Pakistan), Africa (Democratic Republic of Congo, Zambia, and Kenya), and Latin America (Guatemala). A total of 502 648 pregnancies were prospectively enrolled in the registry.
Exposures


Risk factors were added sequentially into the data set in 4 scenarios: (1) prenatal, (2) predelivery, (3) delivery and day 1, and (4) postdelivery through day 2.
Main Outcomes and Measures


Data sets were randomly divided into 10 groups of 3 analysis data sets including training (60%), test (20%), and validation (20%). Conventional and advanced machine learning modeling techniques were applied to assess predictive abilities using area under the curve (AUC) for intrapartum stillbirth and neonatal mortality.
Results


All prenatal and predelivery models had predictive accuracy for both intrapartum stillbirth and neonatal mortality with AUC values 0.71 or less. Five of 6 models for neonatal mortality based on delivery/day 1 and postdelivery/day 2 had increased predictive accuracy with AUC values greater than 0.80. Birth weight was the most important predictor for neonatal death in both postdelivery scenarios with independent predictive ability with AUC values of 0.78 and 0.76, respectively. The addition of 4 other top predictors increased AUC to 0.83 and 0.87 for the postdelivery scenarios, respectively.
Conclusions and Relevance


Models based on prenatal or predelivery data had predictive accuracy for intrapartum stillbirths and neonatal mortality of AUC values 0.71 or less. Models that incorporated delivery data had good predictive accuracy for risk of neonatal mortality. Birth weight was the most important predictor for neonatal mortality.",2020,All prenatal and predelivery models had predictive accuracy for both intrapartum stillbirth and neonatal mortality with AUC values 0.71 or less.,"['A total of 502\u202f648 pregnancies were prospectively enrolled in the registry', ""Participants\n\n\nThis cohort study used data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research population-based vital registry, including clinical sites in South Asia (India and Pakistan), Africa (Democratic Republic of Congo, Zambia, and Kenya), and Latin America (Guatemala""]",[],"['neonatal death', 'neonatal mortality', 'predictive accuracy with AUC values', 'Birth weight', 'predictive abilities using area under the curve (AUC) for intrapartum stillbirth and neonatal mortality', 'AUC']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}]",[],"[{'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}]",502648.0,0.0483834,All prenatal and predelivery models had predictive accuracy for both intrapartum stillbirth and neonatal mortality with AUC values 0.71 or less.,"[{'ForeName': 'Vivek V', 'Initials': 'VV', 'LastName': 'Shukla', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Eggleston', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Musaku', 'Initials': 'M', 'LastName': 'Mwenechanya', 'Affiliation': ""UTH-Children's Hospital, Lusaka, Zambia.""}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bauserman', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': 'KLE Academy of Higher Education and Research, J. N. Medical College, Belgaum, India.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garcés', 'Affiliation': 'INCAP, Guatemala City, Guatemala.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Lata Medical Research Foundation, Datta Meghe Institute of Medical Sciences, Nagpur, India.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Hibberd', 'Affiliation': 'Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Bucher', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.26750']
2328,33206228,Efficacy of intradialytic amino acids on nutritional status in children with stage 5 chronic kidney disease.,"BACKGROUND


Protein energy wasting (PEW) is a common cause of morbidity and mortality in patients with stage 5 chronic kidney disease (CKD 5). Intradialytic parenteral nutrition (IDPN) has been used as a therapy for preventing and treating PEW in children with CKD 5 when other conventional modalities fail. However, not enough data is available to define its effectiveness in treating malnutrition in children. This study aims to investigate potential benefits of IDPN in Egyptian children with CKD 5.
METHODS


In this prospective, placebo-controlled, parallel-group single blinded study, we enrolled 50 CKD 5 patients; 25 patients (intervention group) received intravenous amino acids (KIDIMN), while 25 patients (control group) received normal saline as placebo, each given during regular dialysis 3 times a week for 9 months. Patients were subjected to nutritional assessment at baseline and 3-, 6-, and 9-month follow-up using height Z-score, hand grip strength (HGS) for muscle power assessment, body composition monitor (BCM) for assessing lean tissue mass (LTM) and adipose tissue mass (ATM), and biochemical measures including serum albumin, serum triglyceride, and serum cholesterol.
RESULTS


When comparing baseline and 9-month follow-up values, significant improvement was recorded in height Z-score, LTM, and serum albumin in the intervention group unlike the control group where no significant changes were recorded.
CONCLUSION


IDPN is proposed to be an effective method for preventing and treating malnutrition in children with CKD 5. However, further multi-centric studies with larger sample size and longer duration of follow-up are still recommended.",2020,"When comparing baseline and 9-month follow-up values, significant improvement was recorded in height Z-score, LTM, and serum albumin in the intervention group unlike the control group where no significant changes were recorded.
","['enrolled 50 CKD 5 patients; 25 patients (intervention group) received', 'children with CKD 5', 'children with CKD', 'patients with stage 5 chronic kidney disease (CKD 5', 'Egyptian children with CKD 5', 'children with stage 5 chronic kidney disease', 'children']","['intradialytic amino acids', 'Intradialytic parenteral nutrition (IDPN', 'placebo', 'IDPN', 'intravenous amino acids (KIDIMN), while 25 patients (control group) received normal saline as placebo']","['height Z-score, LTM, and serum albumin', 'nutritional status', 'height Z-score, hand grip strength (HGS) for muscle power assessment, body composition monitor (BCM) for assessing lean tissue mass (LTM) and adipose tissue mass (ATM), and biochemical measures including serum albumin, serum triglyceride, and serum cholesterol']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2316810', 'cui_str': 'Chronic kidney disease stage 5'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}]","[{'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C3805091', 'cui_str': 'Intradialytic parenteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}]",50.0,0.0249889,"When comparing baseline and 9-month follow-up values, significant improvement was recorded in height Z-score, LTM, and serum albumin in the intervention group unlike the control group where no significant changes were recorded.
","[{'ForeName': 'Hagar El-Saied Saad', 'Initials': 'HES', 'LastName': 'El-Serw', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Dina Abdel Rasoul Helal', 'Initials': 'DARH', 'LastName': 'Bassiouni', 'Affiliation': 'Faculty of Medicine, Pediatric Department, Mansoura University, Elgomhoria Street, Mansoura, Egypt. d_A_h_b@yahoo.com.'}, {'ForeName': 'Angy Adel', 'Initials': 'AA', 'LastName': 'Al-Wakeil', 'Affiliation': 'Faculty of Medicine, Pediatric Department, Mansoura University, Elgomhoria Street, Mansoura, Egypt.'}, {'ForeName': 'Ragaa Shawky Aly Ibrahim', 'Initials': 'RSAI', 'LastName': 'El-Masry', 'Affiliation': 'Public Health & Preventive Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ashraf Mohamed Abd Ei Basset', 'Initials': 'AMAEB', 'LastName': 'Bakr', 'Affiliation': 'Faculty of Medicine, Pediatric Department, Mansoura University, Elgomhoria Street, Mansoura, Egypt.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04806-x']
2329,33206229,Adsorption therapy in critically ill with septic shock and acute kidney injury: a retrospective and prospective cohort study.,"BACKGROUND


Haemoadsorption has been described as an effective way to control increased pro- and anti-inflammatory mediators (""cytokine storm"") in septic shock patients. No prospective or randomised clinical study has yet confirmed these results. However, no study has yet prospectively specifically investigated patients in severe septic shock with sepsis-associated acute kidney injury (SA-AKI). Therefore, we aimed to examine whether haemoadsorption could influence intensive care unit (ICU) and hospital mortality in these patients. Furthermore, we examined the influence of haemoadsorption on length of stay in the ICU and therapeutic support.
METHODS


Retrospective control group and prospective intervention group design in a tertiary hospital in central Europe (Germany). Intervention was the implementation of haemoadsorption for patients in septic shock with SA-AKI. 76 patients were included in this analysis.
RESULTS


Severity of illness as depicted by APACHE II was higher in patients treated with haemoadsorption. Risk-adjusted ICU mortality rates (O/E ratios) did not differ significantly between the groups (0.80 vs. 0.83). We observed in patients treated with haemoadsorption a shorter LOS and shorter therapeutic support such as catecholamine dependency and duration of RRT. However, in multivariate analysis (logistic regression for mortality, competing risk for LOS), we found no significant differences between the two groups.
CONCLUSIONS


The implementation of haemoadsorption for patients in septic shock with acute renal failure did not lead to a reduction in ICU or hospital mortality rates. Despite univariate analysis delivering some evidence for a shorter duration of ICU-related treatments in the haemoadsorption group, these results did not remain significant in multivariate analysis. Trial registration CytoSorb ®  registry https://clinicaltrials.gov/ct2/show/NCT02312024 . December 9, 2014.
DATABASE


https://www.cytosorb-registry.org/ (registration for content acquisition is necessary).",2020,Risk-adjusted ICU mortality rates (O/E ratios) did not differ significantly between the groups (0.80 vs. 0.83).,"['76 patients were included in this analysis', 'septic shock patients', 'tertiary hospital in central Europe (Germany', 'critically ill with septic shock and acute kidney injury']",['Adsorption therapy'],"['intensive care unit (ICU) and hospital mortality', 'ICU or hospital mortality rates', 'Risk-adjusted ICU mortality rates (O/E ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0001674', 'cui_str': 'Adsorption'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",76.0,0.126252,Risk-adjusted ICU mortality rates (O/E ratios) did not differ significantly between the groups (0.80 vs. 0.83).,"[{'ForeName': 'Gregor A', 'Initials': 'GA', 'LastName': 'Schittek', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria. gregor.schittek@medunigraz.at.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zoidl', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eichinger', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Orlob', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Simonis', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rief', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Metnitz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Division of General Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Fellinger', 'Affiliation': 'Austrian Centre for Documentation and Quality Assurance in Intensive Care, Vienna, Austria.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Soukup', 'Affiliation': 'Department of Anaesthesiology, Intensive and Palliative Care, Carl-Thiem-Hospital Cottbus, Cottbus, Germany.'}]",Annals of intensive care,['10.1186/s13613-020-00772-7']
2330,33206251,The effects of two different intensities of aerobic training protocols on pain and serum neuro-biomarkers in women migraineurs: a randomized controlled trail.,"OBJECTIVES


We have a weak understanding of how aerobic training may influence migraine, and the optimal parameters for exercise regimens as migraine therapy are not clear. The objectives of this study were to assess, first, effects of two different intensities of aerobic exercise on migraine headache indices; second, serum neuro-biomarker in women migraineurs.
METHODS


A total of 45 non-athlete female migraine patients were selected by a neurologist and randomly divided into three groups: control (CON), moderate-intensity aerobic training (MOD T), and high-intensity aerobic training (HIGH T). Before and after the training protocol, body composition factors, migraine pain indices, VO 2 max, and serum Adenylate-Cyclase Activating Polypeptide (PACAP) and Substance P (SP) were measured. Exercise training protocol includes two different intensities of aerobic exercise: Moderate (13-15 Borg Scale, 60-80% HRmax) and High (15-17 Borg Scale, 65-95% HRmax).
RESULTS


Moderate-intensity aerobic training (MOD T) reduced headache intensity, frequency, and duration in women with migraine (p < 0.001, for all). Also, high-intensity aerobic training (HIGH T) reduced headache intensity, frequency, and duration (p < 0.001, for all). However, for headache intensity and duration, MOD T was effective rather than HIGH T (p < 0.001; p ≤ 0.05, respectively). In addition, neither MOD T nor HIGH T could not alter PACAP and SP contents (p = 0.712; p = 0.249, respectively).
CONCLUSIONS


Our results demonstrated that either MOD T or HIGH T could modify migraine pain indices but neither MOD T nor HIGH T could not alter the PACAP and SP contents in women with migraine.",2020,"However, for headache intensity and duration, MOD T was effective rather than HIGH T (p < 0.001; p ≤ 0.05, respectively).","['women migraineurs', 'women with migraine', '45 non-athlete female migraine patients']","['MOD T or HIGH T', 'aerobic training protocols', 'aerobic exercise', 'control (CON), moderate-intensity aerobic training (MOD T), and high-intensity aerobic training (HIGH T']","['migraine pain indices', 'migraine headache indices', 'pain and serum neuro-biomarkers', 'high-intensity aerobic training (HIGH T) reduced headache intensity, frequency, and duration', 'headache intensity, frequency, and duration in women with migraine', 'PACAP and SP contents', 'body composition factors, migraine pain indices, VO 2 max, and serum Adenylate-Cyclase Activating Polypeptide (PACAP) and Substance P (SP', 'headache intensity and duration, MOD T']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0001492', 'cui_str': 'Adenylate cyclase'}, {'cui': 'C1305923', 'cui_str': 'Polypeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",45.0,0.027684,"However, for headache intensity and duration, MOD T was effective rather than HIGH T (p < 0.001; p ≤ 0.05, respectively).","[{'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Eslami', 'Affiliation': ""Faculty of Sport Science, AllamehTabataba'i University, Tehran, Iran.""}, {'ForeName': 'Abdolhossein', 'Initials': 'A', 'LastName': 'Parnow', 'Affiliation': 'Exercise Physiology Department, Faculty of Sports Sciences, Razi University, Kermanshah, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pairo', 'Affiliation': 'Exercise Physiology Department, Faculty of Sports Sciences, Razi University, Kermanshah, Iran.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, Nikaia, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland. beat.knechtle@hispeed.ch.'}]",European journal of applied physiology,['10.1007/s00421-020-04551-x']
2331,33209928,Nursing empowerment by simulation in percutaneous endoscopic gastrostomy short-time complication control: Protocol study.,"BACKGROUND


Percutaneous endoscopic gastrostomy (PEG) is one of the most suitable methods for long-term nutritional support. In this study, the empowerment of intensive care nurses is examined by a simulation technique to control the short-term complications of PEG.
METHODS


A two-group clinical trial study will be conducted on eighty intensive care nurses in a teaching hospital in Tehran. The study participants will be randomly assigned to one of the two control and intervention groups based on the inclusion criteria. A pretest will be given to both groups using a researcher-made tool. Then, the empowerment package developed by the researcher will be provided to the intervention group in two stages. Next, a posttest will be administered. After this stage, patients' complications with PEG will be observed using a researcher-made checklist. Nurses' performances in both control and intervention groups will be evaluated in terms of preventing and controlling short-term complications up to 1 week after PEG insertion. All of the data collected in this research will be analyzed with statistic tests such as independent  t -test, standard deviation, T pair, ANOVA, and mean based on the SPSS 16 software.
RESULTS


At present, the research team is designing an empowerment package for nurses and tools needed to evaluate the nurses' empowerment.
CONCLUSION


This study will attempt to design and evaluate the empowerment package of graduate nurses with a cognitive empowerment approach and using a simulation technique to care for patients with PEG and to control their short-term complications.",2020,Nurses' performances in both control and intervention groups will be evaluated in terms of preventing and controlling short-term complications up to 1 week after PEG insertion.,"['patients with PEG and to control their short-term complications', 'eighty intensive care nurses in a teaching hospital in Tehran']",['Percutaneous endoscopic gastrostomy (PEG'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0586960', 'cui_str': 'Intensive therapy nurse'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy'}]",[],,0.0372118,Nurses' performances in both control and intervention groups will be evaluated in terms of preventing and controlling short-term complications up to 1 week after PEG insertion.,"[{'ForeName': 'Anahita Zarei', 'Initials': 'AZ', 'LastName': 'Mahmodabadi', 'Affiliation': 'The Department of Critical Care Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Zakerimoghadam', 'Affiliation': 'The Department of Medical Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samerand Ghazi', 'Initials': 'SG', 'LastName': 'Fatah', 'Affiliation': 'Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sohrabi', 'Affiliation': 'Cancer Control Research Center, Cancer Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra Abbasi', 'Initials': 'ZA', 'LastName': 'Dolatabadi', 'Affiliation': 'The Department of Critical Care Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_155_19']
2332,33209932,The potential beneficial effects of education and familiarity with cesarean section procedure and the operating room environment on promotion of anxiety and pain intensity: A randomized controlled clinical trial.,"BACKGROUND


Anxiety before and pain intensity after cesarean section is among the factors that should be taken into consideration among the candidates for cesarean section. The present study aimed to investigate the effect of familiarity with cesarean section and the operating room environment on anxiety and pain intensity among the mothers undergoing cesarean section.
METHODS


This clinical trial was conducted on 80 women referred to the hospitals affiliated to Shiraz University of Medical Sciences for cesarean section in 2018. The participants were randomly divided into a control ( n  = 40) and an intervention group ( n  = 40). The intervention group took part in four educational sessions, while the control group received the hospital's routine care. The Beck Anxiety Inventory was completed by the two groups before and after the intervention. The McGill Pain Questionnaire was also filled out by the two groups in the ward after the cesarean section. After all, the data were entered into the SPSS software, version 21, and were analyzed using independent  t -test and ANCOVA.
RESULTS


The results showed no significant difference between the two groups regarding the mean score of anxiety prior to the intervention. After the intervention, the mean score of anxiety was 7.98 ± 3.77 in the intervention group and 19.70 ± 6.45 in the control group, and the difference was statistically significant ( P  < 0.0001). Indeed, the mean intensity of pain was 43.98 ± 7.63 in the intervention group and 57.75 ± 10.69 in the control group after the intervention, and the difference was statistically significant ( P  < 0.017).
CONCLUSION


The patients' familiarity with cesarean section and the operating room environment caused a decline in the anxiety level prior to cesarean section as well as a decrease in the score of pain after the operation. Hence, midwives and nurses have to play effective roles in decreasing pregnant women's anxiety and pain through identification of strategies for empowering them and managing their worries.",2020,The patients' familiarity with cesarean section and the operating room environment caused a decline in the anxiety level prior to cesarean section as well as a decrease in the score of pain after the operation.,"['80 women referred to the hospitals affiliated to Shiraz University of Medical Sciences for cesarean section in 2018', 'mothers undergoing cesarean section']","['familiarity with cesarean section and the operating room environment', ""intervention group took part in four educational sessions, while the control group received the hospital's routine care"", 'cesarean section procedure and the operating room environment']","['Beck Anxiety Inventory', 'score of pain', 'McGill Pain Questionnaire', 'anxiety level prior to cesarean section', 'mean intensity of pain', 'anxiety and pain intensity', 'mean score of anxiety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",80.0,0.03237,The patients' familiarity with cesarean section and the operating room environment caused a decline in the anxiety level prior to cesarean section as well as a decrease in the score of pain after the operation.,"[{'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Eslami', 'Affiliation': 'Department of Anesthesia, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Hatami', 'Affiliation': 'Surgical Technologists, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Amiri', 'Affiliation': 'Surgical Technologists, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Akbarzadeh', 'Affiliation': 'Department of Midwifery, Maternal-Fetal Medicine Research Center, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_31_20']
2333,33209935,Efficacy of Lecture cum demonstration versus video-based teaching regarding active management of third stage of labor in terms of knowledge and skills of GNM students: An interventional study.,"INTRODUCTION


Educational interventions have been associated with improved performance and significant changes, especially in perinatal outcomes. Teaching is one of the main components in educational planning which is a key factor in conducting educational plans through various teaching strategies such as simulation, demonstration and video teaching.
AIM


The study aimed to assess lecture cum demonstration (LCD) versus video-based teaching (VBT) regarding active management of the third stage of labor (AMTSL) in terms of knowledge and skills of General Nursing Midwifery (GNM) students.
METHODS


This was a quasi-experimental study conducted on 100 GNM third-year students selected by purposive sampling and randomly assigned to LCD ( n  = 50) and VBT ( n  = 50) groups. Sample characteristics performa, Structured Knowledge Questionnaire, and observational checklist were used to collect data from GNM students through self-report and observational technique.
RESULTS


The study results showed that the mean posttest knowledge scores of LCD (17.32 ± 2.14) and VBT group (16.90 ± 2.41) were nearly equal and mean rank posttest skills score of LCD group (54.40) was slightly higher than VBT group (49.51), but computed ""  t  "" value of mean posttest knowledge and computed ""  Z  "" value of skill score of both LCD and VBT group (0.47, 0.54) were found to be statistically non-significant at 0.05 level of significance.
CONCLUSION


It can be concluded that both LCD and VBT were found to be effective in improving knowledge and skills of GNM students regarding AMTSL.",2020,It can be concluded that both LCD and VBT were found to be effective in improving knowledge and skills of GNM students regarding AMTSL.,"['100 GNM third-year students selected by purposive sampling and randomly assigned to', 'GNM students']","['VBT', 'LCD', 'lecture cum demonstration (LCD) versus video-based teaching (VBT', 'Lecture cum demonstration versus video-based teaching']",['mean posttest knowledge scores of LCD'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0332287', 'cui_str': 'With'}]",,0.0209616,It can be concluded that both LCD and VBT were found to be effective in improving knowledge and skills of GNM students regarding AMTSL.,"[{'ForeName': 'Deepshikha', 'Initials': 'D', 'LastName': 'David', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana, India.'}, {'ForeName': 'Simarjeet', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana, India.'}, {'ForeName': 'Adiba', 'Initials': 'A', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Sarin', 'Affiliation': 'Department of Obstetrics and Gynaecological Nursing, Faculty of Nursing, Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Ambala, Haryana, India.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_236_20']
2334,33209939,The effect of motivational interviewing-based training on the rate of using mental health services and intensity of suicidal ideation in individuals with suicide attempt admitted to the emergency department.,"BACKGROUND AND OBJECTIVE


Unless mental health care is provided to suicide attempters after discharge from the emergency department, suicide prevention opportunities may be lost. The purpose of this study was to determine the effect of motivational interviewing (MI)-based training on using mental health services and reducing the severity of suicidal thoughts.
METHODS


This quasi-experimental study was performed on seventy suicide attempters who had been admitted to the emergency department of three university hospitals in Southeast Iran in 2019. Eligible patients were chosen through convenience sampling, and they were randomly divided into the experimental ( n  = 35) and control ( n  = 35) groups. The intervention group received three MI sessions on the day of discharge and the 1 st  week after discharge. Twelve weeks after the intervention, the Beck Scale for Suicidal Ideation and the using mental health services were completed in both the groups. Data were analyzed using Chi-squared test, independent  t -test, and paired  t -test.
RESULTS


While there was no significant difference between the two groups in terms of the mean score of suicidal ideation on the pretest, the experimental group experienced a significant decrease in this respect at the end of the study; thus, this group scored 8.86 ± 5.30, which is considerably lower than that obtained in the control group (15.85 ± 6.65) ( P  = 0.0001). Furthermore, at the end of the study, the rate of using mental health services increased much more in the experimental group than in the control group ( P  = 0.01).
CONCLUSION


MI training had a significant positive impact on mitigating suicidal ideation and promoting mental health services use. To improve mental health and to better serve suicidal individuals, it is recommended that short-term interventions be developed in the form of post-discharge education for suicidal patients admitted to the emergency department.",2020,"While there was no significant difference between the two groups in terms of the mean score of suicidal ideation on the pretest, the experimental group experienced a significant decrease in this respect at the end of the study; thus, this group scored 8.86 ± 5.30, which is considerably lower than that obtained in the control group (15.85 ± 6.65) ( P  = 0.0001).","['seventy suicide attempters who had been admitted to the emergency department of three university hospitals in Southeast Iran in 2019', 'individuals with suicide attempt admitted to the emergency department', 'suicidal patients admitted to the emergency department']","['MI training', 'motivational interviewing-based training', 'MI sessions', 'motivational interviewing (MI)-based training']","['mental health', 'Beck Scale for Suicidal Ideation and the using mental health services', 'rate of using mental health services', 'mitigating suicidal ideation', 'mean score of suicidal ideation']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.026709,"While there was no significant difference between the two groups in terms of the mean score of suicidal ideation on the pretest, the experimental group experienced a significant decrease in this respect at the end of the study; thus, this group scored 8.86 ± 5.30, which is considerably lower than that obtained in the control group (15.85 ± 6.65) ( P  = 0.0001).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Sedghy', 'Affiliation': 'Department of Nursing, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Yoosefi', 'Affiliation': 'Department of Counseling and Psychology, University of Kurdistan, Kurdistan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Pregnancy Health Research Center, School of Nursing and Midwifery, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_344_20']
2335,33207083,"Screening to identify postoperative pain and cross-sectional associations between factors identified in this process with pain and function, three months after total knee replacement.","OBJECTIVES


Describe the screening and recruitment process of a randomised trial and evaluate associations with knee pain and function three months after total knee replacement (TKR).
METHODS


To screen for a multi-centre trial, 5036 patients were sent an Oxford Knee Score (OKS) questionnaire 10 weeks post-TKR. Patients who reported pain in their replaced knee (≤14 on OKS pain component), completed a second OKS 12 weeks post-TKR. Those still experiencing pain 12 weeks post-TKR completed a detailed questionnaire 13 weeks post-TKR. These data were used to characterise pain in a cross-sectional analysis. Multivariable regression was performed, identifying factors associated with pain and function at 13 weeks post-TKR.
RESULTS


We received OKS questionnaires from 3058/5063 (60%) TKR patients, 907/3058 (30%) reported pain in their replaced knee 10-weeks post-operatively. By 12-weeks, 179/553 (32%) patients reported improved pain (OKS>14). At 13-weeks, 192/363 (53%) who completed a detailed questionnaire reported neuropathic pain, 94/362 (26%) reported depression symptoms and 95/363 (26%) anxiety symptoms. More severe pain at 13-weeks post-operatively was associated with poorer general health, poorer physical health, more pain worry and lower satisfaction with surgery outcome. More severe functional limitation was associated with higher levels of depression, more pain worry, lower satisfaction with surgery outcome and higher pain acceptance.
CONCLUSIONS


Screening after TKR identified people with pain. We identified several potential targets (physical and mental health outcomes, acceptance of pain and quality of life) for tailored intervention to improve outcomes for patients. Trials of multidisciplinary interventions are now needed.",2020,"More severe pain at 13-weeks post-operatively was associated with poorer general health, poorer physical health, more pain worry and lower satisfaction with surgery outcome.","['5036 patients were sent an Oxford Knee Score (OKS) questionnaire 10 weeks post-TKR', 'patients', 'Patients who reported pain in their replaced knee (≤14 on OKS pain component']",['total knee replacement (TKR'],"['depression symptoms', 'anxiety symptoms', 'several potential targets (physical and mental health outcomes, acceptance of pain and quality of life', 'neuropathic pain', 'pain (OKS>14', 'levels of depression, more pain worry, lower satisfaction with surgery outcome and higher pain acceptance', 'poorer general health, poorer physical health, more pain worry and lower satisfaction', 'severe pain', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",5036.0,0.105965,"More severe pain at 13-weeks post-operatively was associated with poorer general health, poorer physical health, more pain worry and lower satisfaction with surgery outcome.","[{'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Wylde', 'Affiliation': 'Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'Bristol Trials Centre (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Trials Centre (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bertram', 'Affiliation': 'Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Howells', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Warwick, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Eccleston', 'Affiliation': 'Centre for Pain Research, The University of Bath, Bath, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",Arthritis care & research,['10.1002/acr.24516']
2336,33207093,Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes.,"BACKGROUND


Type 1 diabetes is an autoimmune disease characterized by progressive loss of pancreatic beta cells. Golimumab is a human monoclonal antibody specific for tumor necrosis factor  α  that has already been approved for the treatment of several autoimmune conditions in adults and children. Whether golimumab could preserve beta-cell function in youth with newly diagnosed overt (stage 3) type 1 diabetes is unknown.
METHODS


In this phase 2, multicenter, placebo-controlled, double-blind, parallel-group trial, we randomly assigned, in a 2:1 ratio, children and young adults (age range, 6 to 21 years) with newly diagnosed overt type 1 diabetes to receive subcutaneous golimumab or placebo for 52 weeks. The primary end point was endogenous insulin production, as assessed according to the area under the concentration-time curve for C-peptide level in response to a 4-hour mixed-meal tolerance test (4-hour C-peptide AUC) at week 52. Secondary and additional end points included insulin use, the glycated hemoglobin level, the number of hypoglycemic events, the ratio of fasting proinsulin to C-peptide over time, and response profile.
RESULTS


A total of 84 participants underwent randomization - 56 were assigned to the golimumab group and 28 to the placebo group. The mean (±SD) 4-hour C-peptide AUC at week 52 differed significantly between the golimumab group and the placebo group (0.64±0.42 pmol per milliliter vs. 0.43±0.39 pmol per milliliter, P<0.001). A treat-to-target approach led to good glycemic control in both groups, and there was no significant difference between the groups in glycated hemoglobin level. Insulin use was lower with golimumab than with placebo. A partial-remission response (defined as an insulin dose-adjusted glycated hemoglobin level score [calculated as the glycated hemoglobin level plus 4 times the insulin dose] of ≤9) was observed in 43% of participants in the golimumab group and in 7% of those in the placebo group (difference, 36 percentage points; 95% CI, 22 to 55). The mean number of hypoglycemic events did not differ between the trial groups. Hypoglycemic events that were recorded as adverse events at the discretion of investigators were reported in 13 participants (23%) in the golimumab group and in 2 (7%) of those in the placebo group. Antibodies to golimumab were detected in 30 participants who received the drug; 29 had antibody titers lower than 1:1000, of whom 12 had positive results for neutralizing antibodies.
CONCLUSIONS


Among children and young adults with newly diagnosed overt type 1 diabetes, golimumab resulted in better endogenous insulin production and less exogenous insulin use than placebo. (Funded by Janssen Research and Development; T1GER ClinicalTrials.gov number, NCT02846545.).",2020,"A treat-to-target approach led to good glycemic control in both groups, and there was no significant difference between the groups in glycated hemoglobin level.","['youth with newly diagnosed overt (stage 3) type 1 diabetes', 'for 52 weeks', '84 participants underwent randomization - 56 were assigned to the golimumab group and 28 to the', 'children and young adults (age range, 6 to 21 years) with newly diagnosed overt type 1 diabetes to receive', 'Youth with New-Onset Type 1 Diabetes', '30 participants who received the drug; 29 had', 'children and young adults with newly diagnosed overt type 1 diabetes', 'adults and children']","['subcutaneous golimumab or placebo', 'placebo', 'golimumab', 'Golimumab and Beta-Cell Function']","['mean number of hypoglycemic events', 'glycated hemoglobin level', 'endogenous insulin production', 'adverse events', 'Antibodies to golimumab', 'Hypoglycemic events', 'antibody titers', 'beta-cell function', 'partial-remission response', 'mean (±SD) 4-hour C-peptide AUC', 'insulin use, the glycated hemoglobin level, the number of hypoglycemic events, the ratio of fasting proinsulin to C-peptide over time, and response profile', 'endogenous insulin production, as assessed according to the area under the concentration-time curve for C-peptide level in response to a 4-hour mixed-meal tolerance test']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}]",84.0,0.52987,"A treat-to-target approach led to good glycemic control in both groups, and there was no significant difference between the groups in glycated hemoglobin level.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Quattrin', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Steck', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Eric I', 'Initials': 'EI', 'LastName': 'Felner', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Yinglei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Yichuan', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Ramineh', 'Initials': 'R', 'LastName': 'Zoka', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Hedrick', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Rigby', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vercruysse', 'Affiliation': ""From the Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, and Diabetes Center, John R. Oishei Children's Hospital, Buffalo, NY (T.Q.); the Department of Pediatrics, University of Florida, Gainesville (M.J.H.); the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora (A.K.S.); the Division of Pediatric Endocrinology, Emory University School of Medicine, Atlanta (E.I.F.); Janssen Research and Development, Spring House (Y.L., Y.X., J.H.L.) and Horsham (R.Z., J.A.H., M.R.R.) - both in Pennsylvania; and Janssen Research and Development, Beerse, Belgium (F.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2006136']
2337,33207094,First-Line Lorlatinib or Crizotinib in Advanced  ALK -Positive Lung Cancer.,"BACKGROUND


Lorlatinib, a third-generation inhibitor of anaplastic lymphoma kinase (ALK), has antitumor activity in previously treated patients with  ALK -positive non-small-cell lung cancer (NSCLC). The efficacy of lorlatinib, as compared with that of crizotinib, as first-line treatment for advanced  ALK -positive NSCLC is unclear.
METHODS


We conducted a global, randomized, phase 3 trial comparing lorlatinib with crizotinib in 296 patients with advanced  ALK -positive NSCLC who had received no previous systemic treatment for metastatic disease. The primary end point was progression-free survival as assessed by blinded independent central review. Secondary end points included independently assessed objective response and intracranial response. An interim analysis of efficacy was planned after approximately 133 of 177 (75%) expected events of disease progression or death had occurred.
RESULTS


The percentage of patients who were alive without disease progression at 12 months was 78% (95% confidence interval [CI], 70 to 84) in the lorlatinib group and 39% (95% CI, 30 to 48) in the crizotinib group (hazard ratio for disease progression or death, 0.28; 95% CI, 0.19 to 0.41; P<0.001). An objective response occurred in 76% (95% CI, 68 to 83) of the patients in the lorlatinib group and 58% (95% CI, 49 to 66) of those in the crizotinib group; among those with measurable brain metastases, 82% (95% CI, 57 to 96) and 23% (95% CI, 5 to 54), respectively, had an intracranial response, and 71% of the patients who received lorlatinib had an intracranial complete response. The most common adverse events with lorlatinib were hyperlipidemia, edema, increased weight, peripheral neuropathy, and cognitive effects. Lorlatinib was associated with more grade 3 or 4 adverse events (mainly altered lipid levels) than crizotinib (in 72% vs. 56%). Discontinuation of treatment because of adverse events occurred in 7% and 9% of the patients, respectively.
CONCLUSIONS


In an interim analysis of results among patients with previously untreated advanced  ALK -positive NSCLC, those who received lorlatinib had significantly longer progression-free survival and a higher frequency of intracranial response than those who received crizotinib. The incidence of grade 3 or 4 adverse events was higher with lorlatinib than with crizotinib because of the frequent occurrence of altered lipid levels. (Funded by Pfizer; CROWN ClinicalTrials.gov number, NCT03052608.).",2020,Lorlatinib was associated with more grade 3 or 4 adverse events (mainly altered lipid levels) than crizotinib (in 72% vs. 56%).,"['296 patients with advanced  ALK -positive NSCLC who had received no previous systemic treatment for metastatic disease', 'Advanced  ALK -Positive Lung Cancer', 'patients with previously untreated advanced  ALK -positive NSCLC', 'previously treated patients with  ALK -positive non-small-cell lung cancer (NSCLC']","['lorlatinib with crizotinib', 'First-Line Lorlatinib or Crizotinib']","['longer progression-free survival', 'alive without disease progression', 'events of disease progression or death', 'adverse events', 'objective response', 'hyperlipidemia, edema, increased weight, peripheral neuropathy, and cognitive effects', 'intracranial complete response', 'objective response and intracranial response', 'progression-free survival', 'intracranial response', 'incidence of grade 3 or 4 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0252409', 'cui_str': 'ALK Tyrosine Kinase Receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C4080091', 'cui_str': 'Lorlatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",296.0,0.445648,Lorlatinib was associated with more grade 3 or 4 adverse events (mainly altered lipid levels) than crizotinib (in 72% vs. 56%).,"[{'ForeName': 'Alice T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Bauer', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Polli', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thurm', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Calella', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Peltz', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Solomon', 'Affiliation': ""From the Massachusetts General Hospital Cancer Center (A.T.S.) and Pfizer (G.P.) - both in Boston; Sarah Cannon Research Institute-Tennessee Oncology, Nashville (T.M.B.); European Institute of Oncology, IRCCS (F.M.), and Pfizer (A.P., A.M.C.) - both in Milan; Vall d'Hebron University Hospital and Institute of Oncology, International Oncology Bureau-Quirón, Barcelona (E.F.); National Cancer Center Hospital, Tokyo (Y.G.); Princess Margaret Cancer Centre, Toronto (G.L.); Toulouse University Hospital, Toulouse, France (J.M.); Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea (D.-W.K.); State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Hong Kong (T.M.); Pfizer, La Jolla, CA (H.T.); and Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2027187']
2338,33207131,Reducing EEG (Electroencephalogram) Electrode-induced Skin Injury among Ambulatory EEG Monitored Patients: A Non-randomized Interventional Study of Two Commonly Used Cream-based Products for Electrode Application.,"Ambulatory electroencephalography (AEEG) seeks to capture inter-ictal epileptiform activity or paroxysmal events when patients are not in the clinic. Skin inflammation is a common complication of prolonged EEG monitoring. This non-randomized study aimed to investigate the performance of two commonly used cream-based methods of electrode application in reducing electrode-induced skin injury among patients undergoing AEEG monitoring. A non-randomized interventional study was conducted from July to December 2019 in the Neurosciences Ambulatory Care Unit at Royal Prince Alfred Hospital, Australia. Patients were enrolled into two groups: i) Group T, which received Ten20® Conductive Paste with Tensive® Conductive Adhesive Gel as the primary approach to electrode application; ii). Group E, which received EC2⁺® Conductive Cream as the primary approach to electrode application. Patients in Group T were enrolled in the 1st and 3rd week of the month, and patients in Group E were enrolled in the 2nd and 4th week for each month of the study. A total of 152 patients participated in this study. Two sub-groups were established: those who were monitored for two days (Group T; n = 36, Group E; n = 30) and those who were monitored for four days (Group T; n = 43, Group E; n = 43). Significant (p < 0.05) differences indicating greater inflammation in the Group E were noted for both Day 2 and Day 4 participants. Skin injury/inflammation was significantly less using the standard method (Group T: Ten20® with Tensive® gel) when compared to EC2⁺® (Group E) as the conductive material at the electrode site.",2020,Skin injury/inflammation was significantly less using the standard method (Group T: Ten20® with Tensive® gel) when compared to EC2⁺® (Group E) as the conductive material at the electrode site.,"['Ambulatory EEG Monitored Patients', '152 patients participated in this study', 'July to December 2019 in the Neurosciences Ambulatory Care Unit at Royal Prince Alfred Hospital, Australia', 'patients undergoing AEEG monitoring', 'Patients were enrolled into two groups: i']","['Ambulatory electroencephalography (AEEG', 'EC2⁺® Conductive Cream', 'EC2⁺®']","['Reducing EEG (Electroencephalogram', 'Skin injury/inflammation']","[{'cui': 'C0430799', 'cui_str': 'Ambulatory EEG'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0281980', 'cui_str': 'Injury of integument'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",152.0,0.0227521,Skin injury/inflammation was significantly less using the standard method (Group T: Ten20® with Tensive® gel) when compared to EC2⁺® (Group E) as the conductive material at the electrode site.,"[{'ForeName': 'Sumika', 'Initials': 'S', 'LastName': 'Ouchida', 'Affiliation': 'Comprehensive Epilepsy Service, Royal Prince Alfred Hospital , Camperdown, Sydney, Australia.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Nikpour', 'Affiliation': 'Comprehensive Epilepsy Service, Royal Prince Alfred Hospital , Camperdown, Sydney, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fairbrother', 'Affiliation': 'Faculty of Medicine & Health, University of Sydney , Sydney, Australia.'}]",The Neurodiagnostic journal,['10.1080/21646821.2020.1829894']
2339,33207233,"Validation of an enhanced recovery after surgery protocol in gynecological surgery: an Italian randomized study, a response.",,2020,,['gynecological surgery'],[],[],"[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]",[],[],,0.0609988,,"[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili Brescia, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.11.009']
2340,33207242,Spinal or Cortical direct current stimulation: Which is the best? Evidence from apraxia of speech in post-stroke aphasia.,"To date, new advances in technology have already shown the effectiveness of non-invasive brain stimulation and, in particular, of transcranial direct current stimulation (tDCS), in enhancing language recovery in post-stroke aphasia. More recently, it has been suggested that the stimulation over the spinal cord improves the production of words associated to sensorimotor schemata, such as action verbs. Here, for the first time, we present evidence that transpinal direct current stimulation (tsDCS) combined with a language training is efficacious for the recovery from speech apraxia, a motor speech disorder which might co-occur with aphasia. In a randomized-double blind experiment, ten aphasics underwent five days of tsDCS with concomitant treatment for their articulatory deficits in two different conditions: anodal and sham. In all patients, language measures were collected before (T0), at the end (T5) and one week after the end of treatment (F/U). Results showed that only after anodal tsDCS patients exhibited a better accuracy in repeating the treated items. Moreover, these effects persisted at F/U and generalized to other oral language tasks (i.e. picture description, noun and verb naming, word repetition and reading). A further analysis, which compared the tsDCS results with those collected in a matched group of patients who underwent the same language treatment but combined with tDCS, revealed no differences between the two groups. Given the persistency and severity of articulatory deficits in aphasia and the ease of use of tsDCS, we believe that spinal stimulation might result a new innovative approach for language rehabilitation.",2020,Results showed that only after anodal tsDCS patients exhibited a better accuracy in repeating the treated items.,[],"['Spinal or Cortical direct current stimulation', 'anodal tsDCS', 'transcranial direct current stimulation (tDCS', 'transpinal direct current stimulation (tsDCS) combined with a language training']",[],[],"[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023018', 'cui_str': 'Language Training'}]",[],10.0,0.117572,Results showed that only after anodal tsDCS patients exhibited a better accuracy in repeating the treated items.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pisano', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Incoccia', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Marangolo', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy; IRCCS Santa Lucia Foundation, Rome, Italy. Electronic address: paola.marangolo@gmail.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.113019']
2341,33207259,"Risk of inflammation, retinal vasculitis and retinal occlusion-related events with brolucizumab: post-hoc review of HAWK and HARRIER.","OBJECTIVE


An independent Safety Review Committee (SRC; supported by Novartis Pharma AG [Basel, Switzerland]) analyzed investigator-reported cases of intraocular inflammation (IOI), endophthalmitis and retinal arterial occlusion in the phase 3 HAWK and HARRIER trials of brolucizumab versus aflibercept in neovascular age-related macular degeneration (nAMD).
DESIGN


A post-hoc analysis of a subset of data from two 2-year, double-masked, multicenter, active-controlled randomized phase 3 trials (NCT02307682, NCT02434328).
PARTICIPANTS


Patients (N=1817) with untreated, active choroidal neovascularization due to AMD in the study eye were randomized and treated in HAWK/HARRIER. The SRC reviewed data from cases of investigator-reported IOI (60/1088 brolucizumab-treated eyes; 8/729 aflibercept-treated eyes).
METHODS


The SRC received details and images (color fundus photography, fluorescein angiography and optical coherence tomography) for all investigator-determined cases of IOI, retinal arterial occlusion and endophthalmitis. Cases were reviewed in detail by ≥2 readers, then adjudicated by the SRC as a group.
MAIN OUTCOME MEASURES


Within this subset of patients: incidence of IOI, signs and incidence of retinal vasculitis and/or retinal vascular occlusion, and visual acuity loss; time since first brolucizumab injection to IOI event onset; frequency of visual acuity loss following brolucizumab injection by time of first IOI event onset.
RESULTS


Fifty brolucizumab-treated eyes were considered to have definite/probable drug-related events within the spectrum of IOI, retinal vasculitis and/or vascular occlusion. Based on these cases, incidence of definite/probable IOI was 4.6% (IOI + vasculitis, 3.3%; IOI + vasculitis + occlusion, 2.1%). There were 8 cases (incidence 0.74%) of at least moderate visual acuity loss (≥15 ETDRS letters) in eyes with IOI; 7 were in eyes with IOI + vasculitis + occlusion. Of the 8 cases, 5 experienced their first IOI-related event within 3 months of the first brolucizumab injection (increasing to 7/8 within 6 months). Incidence of IOI in aflibercept-treated eyes was 1.1%, with at least moderate visual acuity loss in 0.14%.
CONCLUSIONS


This analysis of IOI cases following brolucizumab injection identified signs of retinal vasculitis with or without retinal vascular occlusion, and an associated risk of visual acuity loss. The findings will help physicians to evaluate the risks and benefits of brolucizumab treatment for nAMD.",2020,"This analysis of IOI cases following brolucizumab injection identified signs of retinal vasculitis with or without retinal vascular occlusion, and an associated risk of visual acuity loss.","['Patients (N=1817) with untreated, active choroidal neovascularization due to AMD in the study eye', 'neovascular age-related macular degeneration (nAMD']","['brolucizumab', 'brolucizumab injection', 'brolucizumab versus aflibercept']","['Incidence of IOI', 'visual acuity loss', 'Risk of inflammation, retinal vasculitis and retinal occlusion', 'incidence of definite/probable IOI', 'IOI, signs and incidence of retinal vasculitis and/or retinal vascular occlusion, and visual acuity loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0234632', 'cui_str': 'Reduced visual acuity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0152026', 'cui_str': 'Retinal vasculitis'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0035326', 'cui_str': 'Retinal vascular occlusion'}]",1817.0,0.203461,"This analysis of IOI cases following brolucizumab injection identified signs of retinal vasculitis with or without retinal vascular occlusion, and an associated risk of visual acuity loss.","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Monés', 'Affiliation': 'Institut de la Màcula, Barcelona, Spain; Barcelona Macula Foundation, Barcelona, Spain.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Departement Hospitalo-Universitaire Vision et Handicaps, Paris, France; Université de Paris, Ophthalmology Department, AP-HP, Hôpital Lariboisière, Rothschild Foundation Hospital, Paris, France.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Albini', 'Affiliation': 'Bascom Palmer Eye Institute, The University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Korobelnik', 'Affiliation': ""CHU Bordeaux, Service d'ophtalmologie, Bordeaux, France; Univ. Bordeaux, INSERM, BPH, U1219, F-33000 Bordeaux, France.""}, {'ForeName': 'Ivana K', 'Initials': 'IK', 'LastName': 'Kim', 'Affiliation': 'Dr. Kim participated in this study as a consultant to Novartis independent of her faculty appointment in the Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pruente', 'Affiliation': 'Department of Ophthalmology, University of Basel, Basel, Switzerland; Department of Ophthalmology, Kantonsspital Baselland, Liestal, Switzerland; Institute of Molecular and Clinical Ophthalmology Basel (IOB), Basel, Switzerland.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Murray', 'Affiliation': 'Murray Ocular Oncology and Retina, Miami, Florida, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts USA. Electronic address: jsheier@eyeboston.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.11.011']
2342,33206053,"The RACCO Trial to Assess the Efficacy and Safety of Inhaled Ciclesonide for Asymptomatic and Mild Patients with Covid-19: A Study Protocol for a Multi-center, Open- labeled, Randomized Controlled Trial.","BACKGROUND


Currently, there are no specific effective treatments for SARS-CoV-2; however, various COVID-19 treatment options are under investigation. It is vital to continue investigating the landscape of SARS-CoV-2-induced pneumonia and therapeutic interventions.
OBJECTIVE


This paper presents the protocol for a study that aims to compare the pneumonia exacerbation rate between ciclesonide (Alvesco R) administration and symptomatic treatment in COVID-19 patients and to determine the efficacy of ciclesonide (Alvesco R). The secondary objectives are to investigate the safety of ciclesonide (Alvesco R) administration, changes in clinical and laboratory findings, and the number of viral genome copies of SARS-CoV-2 over time between the two groups.
METHODS


In this investigator-initiated, exploratory, prospective, multi-center, parallel-group, open-label, randomized trial, a total of 90 patients diagnosed with COVID-19 with specific inclusion/exclusion criteria will be recruited from 21 hospitals in Japan. Participants will be randomized to either the ciclesonide group receiving ciclesonide (Alvesco R) 400 µg dose three times a day over a seven-day period or to the symptomatic treatment group. Both groups will antitussives and antipyretics as required. Data collection for various parameters will be conducted on days 1, 2, 4, 8, 22, and 29 to record baseline assessments and the findings over an extended period. Computed tomography (CT) image scans prior to drug administration and 1 week following treatment will be compared, and efficacy will be confirmed by checking for pneumonia exacerbation. Primary endpoint analysis will be performed using Fisher's exact test to determine statistically significant differences in the pneumonia exacerbation rate between the ciclesonide and symptomatic treatment groups.
RESULTS


The first trial participant was enrolled on April 3, 2020; recruitment is expected to be completed on September 30, 2020, while follow-up assessments of all participants are expected to be completed by October 31, 2020. The study results will be published in a peer-reviewed scientific journal.
CONCLUSIONS


The RACCO study will provide definitive comparative effectiveness data and important clinical outcomes data between the ciclesonide and symptomatic treatment groups. If the hypotheses that pneumonia exacerbation rate reduction is more significant in the ciclesonide treatment group than in the symptomatic treatment group and that ciclesonide is safe for use are valid, ciclesonide (Alvesco R) will serve as an important therapeutic option for COVID-19 patients.
CLINICALTRIAL


Japan Registry of Clinical Trials NCT No jRCTs031190269.
INTERNATIONAL REGISTERED REPORT


DERR1-10.2196/23830.",2020,"If the hypotheses that pneumonia exacerbation rate reduction is more significant in the ciclesonide treatment group than in the symptomatic treatment group and that ciclesonide is safe for use are valid, ciclesonide (Alvesco R) will serve as an important therapeutic option for COVID-19 patients.
","['Asymptomatic and Mild Patients with Covid-19', 'The first trial participant was enrolled on April 3, 2020; recruitment is expected to be completed on September 30, 2020, while follow-up assessments of all participants are expected to be completed by October 31, 2020', '90 patients diagnosed with COVID-19 with specific inclusion/exclusion criteria will be recruited from 21 hospitals in Japan', 'COVID-19 patients']","['Inhaled Ciclesonide', 'ciclesonide group receiving ciclesonide (Alvesco R', 'ciclesonide', 'ciclesonide (Alvesco R', 'NCT']","['pneumonia exacerbation rate reduction', 'Efficacy and Safety', 'pneumonia exacerbation rate']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1174745', 'cui_str': 'Alvesco'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.109477,"If the hypotheses that pneumonia exacerbation rate reduction is more significant in the ciclesonide treatment group than in the symptomatic treatment group and that ciclesonide is safe for use are valid, ciclesonide (Alvesco R) will serve as an important therapeutic option for COVID-19 patients.
","[{'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Terada-Hirashima', 'Affiliation': 'Department of Pulmonary Medicine, Center Hospital of the National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, JP.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pulmonary Medicine, Center Hospital of the National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, JP.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, JP.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Hojo', 'Affiliation': 'Department of Pulmonary Medicine, Center Hospital of the National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, JP.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Mikami', 'Affiliation': 'Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, JP.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sugiura', 'Affiliation': 'Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, JP.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'Disease Control and Prevention Center, Center Hospital of the National Center for Global Health and Medicine, Tokyo, JP.'}, {'ForeName': 'Haruhito', 'Initials': 'H', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Pulmonary Medicine, Center Hospital of the National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, JP.'}]",JMIR research protocols,['10.2196/23830']
2343,33206052,Impact of Patient-Clinical Team Secure Messaging on Communication Patterns and Patient Experience: Randomized Encouragement Design Trial.,"BACKGROUND


Although secure messaging (SM) between patients and clinical team members is a recommended component of continuous care, uptake by patients remains relatively low. We designed a multicomponent Supported Adoption Program (SAP) to increase SM adoption among patients using the Veterans Health Administration (VHA) for primary care.
OBJECTIVE


Our goals were to (1) conduct a multisite, randomized, encouragement design trial to test the effectiveness of an SAP designed to increase patient engagement with SM through VHA's online patient portal (My HealtheVet [MHV]) and (2) evaluate the impact of the SAP and patient-level SM adoption on perceived provider autonomy support and communication. Patient-reported barriers to SM adoption were also assessed.
METHODS


We randomized 1195 patients at 3 VHA facilities who had MHV portal accounts but had never used SM. Half were randomized to receive the SAP, and half served as controls receiving usual care. The SAP consisted of encouragement to adopt SM via mailed educational materials, proactive SM sent to patients, and telephone-based motivational interviews. We examined differences in SM adoption rates between SAP recipients and controls at 9 months and 21 months. Follow-up telephone surveys were conducted to assess perceived provider autonomy support and self-report of telephone communication with clinical teams.
RESULTS


Patients randomized to the SAP had significantly higher rates of SM adoption than the control group (101/595, 17.0% vs 40/600, 6.7%; P<.001). Most adopters in the SAP sent their first message without a motivational interview (71/101, 70.3%). The 10-percentage point difference in adoption persisted a full year after the encouragement ended (23.7%, 142/600 in the SAP group vs 13.5%, 80/595 in the control group, P<.001). We obtained follow-up survey data from 49.54% (592/1195) of the participants. SAP participants reported higher perceived provider autonomy support (5.7 vs 5.4, P=.007) and less telephone use to communicate with their provider (68.8% vs 76.0%, P=.05), compared to patients in the control group. Patient-reported barriers to SM adoption included self-efficacy (eg, not comfortable using a computer, 24%), no perceived need for SM (22%), and difficulties with portal password or login (17%).
CONCLUSIONS


The multicomponent SAP was successful in increasing use of SM 10 percentage points above standard care; new SM adopters reported improved perceptions of provider autonomy support and less use of the telephone to communicate with their providers. Still, despite the encouragement and technical assistance provided through the SAP, adoption rates were lower than anticipated, reaching only 24% at 21 months (10% above controls). Common barriers to adoption such as limited perceived need for SM may be more challenging to address and require different interventions than barriers related to patient self-efficacy or technical difficulties.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02665468; https://clinicaltrials.gov/ct2/show/NCT02665468.",2020,"SAP participants reported higher perceived provider autonomy support (5.7 vs 5.4, P=.007) and less telephone use to communicate with their provider (68.8% vs 76.0%, P=.05), compared to patients in the control group.","['patients using the Veterans Health Administration (VHA) for primary care', '1195 patients at 3 VHA facilities who had MHV portal accounts but had never used SM', 'Communication Patterns and Patient Experience']","['SAP and patient-level SM adoption', 'SAP', 'SAP, and half served as controls receiving usual care', 'multicomponent Supported Adoption Program (SAP']","['SM adoption rates', 'rates of SM adoption', 'provider autonomy support', 'SAP, adoption rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",1195.0,0.0586573,"SAP participants reported higher perceived provider autonomy support (5.7 vs 5.4, P=.007) and less telephone use to communicate with their provider (68.8% vs 76.0%, P=.05), compared to patients in the control group.","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shimada', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Zocchi', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Hogan', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Kertesz', 'Affiliation': 'Birmingham VA Medical Center, Department of Veterans Affairs, Birmingham, AL, United States.'}, {'ForeName': 'Armando J', 'Initials': 'AJ', 'LastName': 'Rotondi', 'Affiliation': 'Center for Health Equity Research and Promotion (CHERP), VA Pittsburgh Healthcare System, Department of Veterans Affairs, Pittsburgh, PA, United States.'}, {'ForeName': 'Jorie M', 'Initials': 'JM', 'LastName': 'Butler', 'Affiliation': 'Innovation, Decision Enhancement & Analytic Sciences (IDEAS) Center, George E. Wahlen Veterans Affairs Medical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Knight', 'Affiliation': 'Innovation, Decision Enhancement & Analytic Sciences (IDEAS) Center, George E. Wahlen Veterans Affairs Medical Center, Salt Lake City, UT, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'DeLaughter', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Kleinberg', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Nicklas', 'Affiliation': 'Center for Healthcare Organization and Implementation Research (CHOIR), VA Bedford Healthcare System, Department of Veterans Affairs, Bedford, MA, United States.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Nazi', 'Affiliation': 'KMN Consulting Services, LTD, Coxsackie, NY, United States.'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Houston', 'Affiliation': 'Section on General Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}]",Journal of medical Internet research,['10.2196/22307']
2344,33206054,Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial.,"BACKGROUND


Video and mobile games have been shown to have a positive impact on behavior change in children. However, the potential impact of game play patterns on outcomes of interest are yet to be understood, especially for games with implicit learning components.
OBJECTIVE


This study investigates the immediate impact of fooya!, a pediatric dietary mobile game with implicit learning components, on food choices. It also quantifies children's heterogeneous game play patterns using game telemetry and determines the effects of these patterns on players' food choices.
METHODS


We analyzed data from a randomized controlled trial (RCT) involving 104 children, aged 10 to 11 years, randomly assigned to the treatment group (played fooya!, a dietary mobile game developed by one of the authors) or the control group (played Uno, a board game without dietary education). Children played the game for 20 minutes each in two sessions. After playing the game in each session, the children were asked to choose 2 out of 6 food items (3 healthy and 3 unhealthy choices). The number of healthy choices in both sessions was used as the major outcome. We first compared the choice and identification of healthy foods between treatment and control groups using statistical tests. Next, using game telemetry, we determined the variability in game play patterns by quantifying game play measures and modeled the process of game playing at any level across all students as a Markov chain. Finally, correlation tests and regression models were used to establish the relationship between game play measures and actual food choices.
RESULTS


We saw a significant main effect of the mobile game on number of healthy foods actually chosen (treatment 2.48, control 1.10; P<.001; Cohen d=1.25) and identified (treatment 7.3, control 6.94; P=.048; Cohen d=.25). A large variation was observed in children's game play patterns. Children played an average of 15 game levels in 2 sessions, with a range of 2 to 23 levels. The greatest variation was noted in the proportion of scoring activities that were highly rewarded, with an average of 0.17, ranging from 0.003 to 0.98. Healthy food choice was negatively associated with the number of unhealthy food facts that children read in the game (Kendall τ=-.32, P=.04), even after controlling for baseline food preference.
CONCLUSIONS


A mobile video game embedded with implicit learning components showed a strong positive impact on children's food choices immediately following the game. Game telemetry captured children's different play patterns and was associated with behavioral outcomes. These results have implications for the design and use of mobile games as an intervention to improve health behaviors, such as the display of unhealthy food facts during game play. Longitudinal RCTs are needed to assess long-term impact.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04082195; https://clinicaltrials.gov/ct2/show/NCT04082195, registered retrospectively.",2020,"We saw a significant main effect of the mobile game on number of healthy foods actually chosen (treatment 2.48, control 1.10; P<.001; Cohen d=1.25) and identified (treatment 7.3, control 6.94; P=.048; Cohen d=.25).","['children', '104 children, aged 10 to 11 years', 'Healthy Eating Behavior']","['treatment group (played fooya!, a dietary mobile game developed by one of the authors) or the control group (played Uno, a board game without dietary education', 'fooya']","['proportion of scoring activities', 'number of healthy choices', 'number of healthy foods actually chosen']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",104.0,0.157051,"We saw a significant main effect of the mobile game on number of healthy foods actually chosen (treatment 2.48, control 1.10; P<.001; Cohen d=1.25) and identified (treatment 7.3, control 6.94; P=.048; Cohen d=.25).","[{'ForeName': 'Yi-Chin', 'Initials': 'YC', 'LastName': 'Kato-Lin', 'Affiliation': 'Hofstra University, Hempstead, NY, United States.'}, {'ForeName': 'Uttara Bharath', 'Initials': 'UB', 'LastName': 'Kumar', 'Affiliation': 'Center for Communication Programs, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Sri Prakash', 'Affiliation': 'FriendsLearn Inc, Palo Alto, CA, United States.'}, {'ForeName': 'Bhairavi', 'Initials': 'B', 'LastName': 'Prakash', 'Affiliation': 'The Mithra Trust, Chennai, India.'}, {'ForeName': 'Vasini', 'Initials': 'V', 'LastName': 'Varadan', 'Affiliation': 'Mind in Motion, Chennai, India.'}, {'ForeName': 'Sanjeeta', 'Initials': 'S', 'LastName': 'Agnihotri', 'Affiliation': 'Center for Communication and Change - India, New Delhi, India.'}, {'ForeName': 'Nrutya', 'Initials': 'N', 'LastName': 'Subramanyam', 'Affiliation': 'Seethapathy Clinic & Hospital, Chennai, India.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Krishnatray', 'Affiliation': 'Center for Communication and Change - India, New Delhi, India.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Padman', 'Affiliation': 'The Heinz College of Information Systems and Public Policy, Carnegie Mellon University, Pittsburgh, PA, United States.'}]",JMIR mHealth and uHealth,['10.2196/15717']
2345,33206055,Mobile Clinical Decision Support System for the Management of Diabetic Patients With Kidney Complications in UK Primary Care Settings: Mixed Methods Feasibility Study.,"BACKGROUND


Attempts to utilize eHealth in diabetes mellitus (DM) management have shown promising outcomes, mostly targeted at patients; however, few solutions have been designed for health care providers.
OBJECTIVE


The purpose of this study was to conduct a feasibility project developing and evaluating a mobile clinical decision support system (CDSS) tool exclusively for health care providers to manage chronic kidney disease (CKD) in patients with DM.
METHODS


The design process was based on the 3 key stages of the user-centered design framework. First, an exploratory qualitative study collected the experiences and views of DM specialist nurses regarding the use of mobile apps in clinical practice. Second, a CDSS tool was developed for the management of patients with DM and CKD. Finally, a randomized controlled trial examined the acceptability and impact of the tool.
RESULTS


We interviewed 15 DM specialist nurses. DM specialist nurses were not currently using eHealth solutions in their clinical practice, while most nurses were not even aware of existing medical apps. However, they appreciated the potential benefits that apps may bring to their clinical practice. Taking into consideration the needs and preferences of end users, a new mobile CDSS app, ""Diabetes & CKD,"" was developed based on guidelines. We recruited 39 junior foundation year 1 doctors (44% male) to evaluate the app. Of them, 44% (17/39) were allocated to the intervention group, and 56% (22/39) were allocated to the control group. There was no significant difference in scores (maximum score=13) assessing the management decisions between the app and paper-based version of the app's algorithm (intervention group: mean 7.24 points, SD 2.46 points; control group: mean 7.39, SD 2.56; t 37 =-0.19, P=.85). However, 82% (14/17) of the participants were satisfied with using the app.
CONCLUSIONS


The findings will guide the design of future CDSS apps for the management of DM, aiming to help health care providers with a personalized approach depending on patients' comorbidities, specifically CKD, in accordance with guidelines.",2020,"There was no significant difference in scores (maximum score=13) assessing the management decisions between the app and paper-based version of the app's algorithm (intervention group: mean 7.24 points, SD 2.46 points; control group: mean 7.39, SD 2.56; t 37 =-0.19, P=.85).","['39 junior foundation year 1 doctors (44% male) to evaluate the app', 'Diabetic Patients With Kidney Complications in UK Primary Care Settings', 'health care providers to manage chronic kidney disease (CKD) in patients with DM']","['Mobile Clinical Decision Support System', 'mobile clinical decision support system (CDSS']",[],"[{'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}]",[],,0.0790841,"There was no significant difference in scores (maximum score=13) assessing the management decisions between the app and paper-based version of the app's algorithm (intervention group: mean 7.24 points, SD 2.46 points; control group: mean 7.39, SD 2.56; t 37 =-0.19, P=.85).","[{'ForeName': 'Hala Ibrahim', 'Initials': 'HI', 'LastName': 'Alhodaib', 'Affiliation': 'Department of Community Health Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Antza', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Joht Singh', 'Initials': 'JS', 'LastName': 'Chandan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Hanif', 'Affiliation': 'Diabetes Centre, University Hospitals Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism Centre, University Hospitals Coventry and Warwickshire, Coventry, United Kingdom.'}, {'ForeName': 'Sunjay', 'Initials': 'S', 'LastName': 'Paul', 'Affiliation': 'The Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sutcliffe', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Krishnarajah', 'Initials': 'K', 'LastName': 'Nirantharakumar', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.'}]",JMIR diabetes,['10.2196/19650']
2346,33206059,Internet and Telerehabilitation-Delivered Management of Rotator Cuff-Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial.,"BACKGROUND


Rotator cuff-related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes.
OBJECTIVE


The primary aim of this pilot randomized controlled trial was to assess the feasibility of a 12-week internet-delivered intervention for RCRSP comparing advice only, recommended care, and recommended care with group-based telerehabilitation.
METHODS


Reporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy. Screening involved an online questionnaire followed by a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) to receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session). Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires. Secondary clinical and patient knowledge outcomes were collected (via email or text) at baseline, six weeks, and 12 weeks (for clinical and patient knowledge), and within-group change was reported descriptively.
RESULTS


We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period. Of the 36 participants, 12 participants were allocated to each of the three trial arms. The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female. Retention at the 12-week endpoint was 94% (34/36) and response to email questionnaires at other time points was 83% or greater. We found acceptable adherence (defined as greater than 70% of participants performing exercise 2 or 3 times/week) in the recommended care group with telerehabilitation but not in the recommended care group without telerehabilitation. There was a total of 24 adverse events over 108 person-months of observation. All adverse events were mild or moderate (mainly muscle and shoulder symptoms), with the exception of one instance of elective surgery (unrelated to the person's shoulder condition).
CONCLUSIONS


Our prespecified success criteria were met or exceeded, but there was a gender imbalance toward women. It is feasible to progress to a fully powered trial, but strategies to address the gender imbalance need to be implemented.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12620000248965); https://tinyurl.com/yy6eztf5.",2020,"Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes.
","['People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy', 'Reporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials', 'We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period', '36 participants, 12 participants', 'The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female', 'Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires']","['Rotator cuff-related shoulder pain (RCRSP', 'receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session', 'Internet and Telerehabilitation-Delivered Management of Rotator Cuff-Related Shoulder Pain (INTEL Trial']","['acceptable adherence', 'response to email questionnaires']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",12.0,0.20208,"Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cridland', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Hopmans', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ashton', 'Affiliation': 'Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'Barwon Orthopaedic Research and Education, Barwon Health and School of Medicine, Deakin University, Geelong, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Skouteris', 'Affiliation': 'Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Haines', 'Affiliation': 'School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, Australia.'}]",JMIR mHealth and uHealth,['10.2196/24311']
2347,33206061,Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration.,"BACKGROUND


Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Women are disproportionately affected by PTSD than men and are more at risk in the occurrence of sexual assault victimization. Estimates suggest that 50% of women develop PTSD following sexual assault and successful clinical management can be challenging. Growing evidence has implicated neural, immune, and endocrine alterations underpinning PTSD, but only few studies have assessed the evolution of acute PTSD in women.
OBJECTIVE


This study aims to measure whether the onset of PTSD is associated with accelerated aging in women following sexual assault. We hypothesize that the increase of allostatic load caused by PTSD leads to neuroprogression. We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline.
METHODS


We will include women between 18 and 45 years of age, who experienced sexual assault from 1 to 6 months before the initial evaluation, and present with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of PTSD. Baseline evaluation will comprise clinical and psychometric assessments, structural and functional magnetic resonance imaging, neuropsychological testing, polysomnography, evaluation of immune and endocrine parameters, and genetic analyses. Age-matched female healthy controls will be included and subjected to the same evaluation. Patients will be randomized for treatment in 1 of the 2 arms of the study for 14 weeks; follow-up will continue until 1 year after inclusion via treatment as usual. The researchers will collect clinical and laboratory data during periodic clinical assessments up to 1-year follow-up.
RESULTS


Data collection started in early 2016 and will be completed by the end of the first semester of 2020. Analyses will be performed soon afterward, followed by the elaboration of several articles. Articles will be submitted in early 2021. This research project has obtained a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP 2014/12559-5).
CONCLUSIONS


We expect to provide insight into the consequences of recent sexual assault exposure in women by investigating the degree of neuroprogression developing from an early stage of PTSD. We also expect to provide important evidence on the efficacy of a non-exposure psychotherapy (IPT-PTSD) to mitigate PTSD symptoms in recently sexually assaulted women. Further, we aim to obtain evidence on how treatment outcomes are associated with neuroprogression measures.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry RBR-3z474z; http://www.ensaiosclinicos.gov.br/rg/RBR-3z474z/.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19162.",2020,"We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline.
","['women between 18 and 45 years of age, who experienced sexual assault from 1 to 6 months before the initial evaluation, and present with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of PTSD', 'Age-matched female healthy controls', 'women following sexual assault']","['interpersonal psychotherapy adapted for PTSD (IPT-PTSD', 'non-exposure psychotherapy (IPT-PTSD']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",[],,0.0937258,"We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline.
","[{'ForeName': 'Bruno Messina', 'Initials': 'BM', 'LastName': 'Coimbra', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Teresa', 'Initials': 'AT', 'LastName': ""D'Elia"", 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mariana Rangel', 'Initials': 'MR', 'LastName': 'Maciel', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carolina Muniz', 'Initials': 'CM', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Milani', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Mozzambani', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Juruena', 'Affiliation': ""Centre for Affective Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, Biomedical Research Centre, South London and Maudsley NHS Foundation Trust and King's College, London, United Kingdom.""}, {'ForeName': 'Sintia Iole', 'Initials': 'SI', 'LastName': 'Belangero', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andrea Parolin', 'Initials': 'AP', 'LastName': 'Jackowski', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Dalva', 'Initials': 'D', 'LastName': 'Poyares', 'Affiliation': 'Department of Psychobiology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andrea Feijo', 'Initials': 'AF', 'LastName': 'Mello', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Feijo', 'Initials': 'MF', 'LastName': 'Mello', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",JMIR research protocols,['10.2196/19162']
2348,33206126,Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial.,"Importance


Up to 20% of patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization. Compared with rates in hospitalized patients, readmission and mortality are worse for ED patients.
Objective


To assess the impact of a self-care intervention on 90-day outcomes in patients with AHF who are discharged from the ED.
Design, Setting, and Participants


Get With the Guidelines in Emergency Department Patients With Heart Failure was an unblinded, parallel-group, multicenter randomized trial. Patients were randomized 1:1 to usual care vs a tailored self-care intervention. Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included. The trial was conducted from October 28, 2015, to September 5, 2019.
Interventions


Home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching for 3 months.
Main Outcomes and Measures


The primary outcome was a global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS) at 90 days. Key secondary outcomes included the global rank outcome at 30 days and changes in the KCCQ-12 SS score at 30 and 90 days. Intention-to-treat analysis was performed for the primary, secondary, and safety outcomes. Per-protocol analysis was conducted including patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm.
Results


Owing to slow enrollment, 479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm. The median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50%. There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28). At day 30, patients in the intervention arm had significantly better global rank (HR, 0.80; 95% CI, 0.64-0.99; P = .04) and a 5.5-point higher KCCQ-12 SS (95% CI, 1.3-9.7; P = .01), while at day 90, the KCCQ-12 SS was 2.7 points higher (95% CI, -1.9 to 7.2; P = .25).
Conclusions and Relevance


The self-care intervention did not improve the primary global rank outcome at 90 days in this trial. However, benefit was observed in the global rank and KCCQ-12 SS at 30 days, suggesting that an early benefit of a tailored self-care program initiated at an ED visit for AHF was not sustained through 90 days.
Trial Registration


ClinicalTrials.gov Identifier: NCT02519283.",2020,"There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28).","['patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm', 'median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50', 'patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization', '479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm', 'October 28, 2015, to September 5, 2019', 'Emergency Department Patients With Heart Failure', 'Discharged From the Emergency Department', 'Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included', 'Patients With Acute Heart Failure', 'patients with AHF who are discharged from the ED']","['self-care intervention', 'Self-care Intervention', 'discharge and twice-monthly telephone-based self-care coaching for 3 months', 'usual care vs a tailored self-care intervention']","['global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS', 'readmission and mortality', 'global rank', '90-Day Outcomes', 'global rank outcome at 30 days and changes in the KCCQ-12 SS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0585303', 'cui_str': 'Twice monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",700.0,0.169533,"There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28).","[{'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Jenkins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Storrow', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Detroit Medical Center, Detroit, Michigan.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University Medical Center, Indianapolis.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Char', 'Affiliation': 'Department of Emergency Medicine, Washington University Medical Center in St Louis, St Louis, Missouri.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Diercks', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Fermann', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio.'}, {'ForeName': 'Jin H', 'Initials': 'JH', 'LastName': 'Han', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hiestand', 'Affiliation': 'Department of Emergency Medicine, Wake Forest University Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hogan', 'Affiliation': 'Department of Emergency Medicine, Virginia Commonwealth University Medical Center, Richmond, Virginia.'}, {'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Kampe', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Khan', 'Affiliation': 'Department of Emergency Medicine, American Heart Association.'}, {'ForeName': 'Sangil', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, University of Iowa Medical Center, Iowa City.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Martindale', 'Affiliation': 'Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Candace D', 'Initials': 'CD', 'LastName': 'McNaughton', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Miller-Reilly', 'Affiliation': 'School of Nursing, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Moser', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Robichaux', 'Affiliation': 'School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Schrock', 'Affiliation': 'Department of Emergency Medicine, Metro Health Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Singer', 'Affiliation': 'Department of Emergency Medicine, Stony Brook University Medical Center, Stony Brook, New York.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Sterling', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ward', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Patient Representative, Stockbridge, Georgia.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson.'}]",JAMA cardiology,['10.1001/jamacardio.2020.5763']
2349,33206257,Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis as Treatment for Incomplete Primary Antibody Deficiency.,"BACKGROUND


Patients with an IgG subclass deficiency (IgSD) ± specific polysaccharide antibody deficiency (SPAD) often present with recurrent infections. Previous retrospective studies have shown that prophylactic antibiotics (PA) and immunoglobulin replacement therapy (IRT) can both be effective in preventing these infections; however, this has not been confirmed in a prospective study.
OBJECTIVE


To compare the efficacy of PA and IRT in a randomized crossover trial.
METHODS


A total of 64 patients (55 adults and 9 children) were randomized (2:2) between two treatment arms. Treatment arm A began with 12 months of PA, and treatment arm B began with 12 months of IRT. After a 3-month bridging period with cotrimoxazole, the treatment was switched to 12 months of IRT and PA, respectively. The efficacy (measured by the incidence of infections) and proportion of related adverse events in the two arms were compared.
RESULTS


The overall efficacy of the two regimens did not differ (p = 0.58, two-sided Wilcoxon signed-rank test). A smaller proportion of patients suffered a related adverse event while using PA (26.8% vs. 60.3%, p < 0.0003, chi-squared test). Patients with persistent infections while using PA suffered fewer infections per year after switching to IRT (2.63 vs. 0.64, p < 0.01).
CONCLUSION


We found comparable efficacy of IRT and PA in patients with IgSD ± SPAD. Patients with persistent infections during treatment with PA had less infections after switching to IRT.
CLINICAL IMPLICATION


Given the costs and associated side-effects of IRT, it should be reserved for patients with persistent infections despite treatment with PA.",2020,"The overall efficacy of the two regimens did not differ (p = 0.58, two-sided Wilcoxon signed-rank test).","['Patients with an IgG subclass deficiency (IgSD)\u2009±\u2009specific polysaccharide antibody deficiency (SPAD) often present with recurrent infections', '64 patients (55 adults and 9 children', 'patients with IgSD ± SPAD', 'patients with persistent infections despite treatment with PA']","['prophylactic antibiotics (PA) and immunoglobulin replacement therapy (IRT', 'cotrimoxazole', 'Immunoglobulin Replacement Therapy Versus Antibiotic Prophylaxis', 'PA', 'PA and IRT', 'IRT and PA']","['overall efficacy', 'incidence of infections) and proportion of related adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162539', 'cui_str': 'Selective immunoglobulin G deficiency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0239998', 'cui_str': 'Recurrent infectious disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",64.0,0.0427257,"The overall efficacy of the two regimens did not differ (p = 0.58, two-sided Wilcoxon signed-rank test).","[{'ForeName': 'Bas M', 'Initials': 'BM', 'LastName': 'Smits', 'Affiliation': 'Department of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Kleine Budde', 'Affiliation': 'Clinical Operations, Sanquin Plasma Products B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'de Vries', 'Affiliation': 'Department of Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Ineke J M', 'Initials': 'IJM', 'LastName': 'Ten Berge', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centers, Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Robbert G M', 'Initials': 'RGM', 'LastName': 'Bredius', 'Affiliation': 'Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van Deuren', 'Affiliation': 'Department of Internal Medicine, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Jaap T', 'Initials': 'JT', 'LastName': 'van Dissel', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, University of Leiden, Leiden, The Netherlands.'}, {'ForeName': 'Pauline M', 'Initials': 'PM', 'LastName': 'Ellerbroek', 'Affiliation': 'Division of Internal Medicine and Dermatology, Department of Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'van der Flier', 'Affiliation': 'Department of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands.'}, {'ForeName': 'P Martin', 'Initials': 'PM', 'LastName': 'van Hagen', 'Affiliation': 'Department of Internal Medicine/Immunology, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Nieuwhof', 'Affiliation': 'Department of Allergology and Clinical Immunology, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rutgers', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Lieke E A M', 'Initials': 'LEAM', 'LastName': 'Sanders', 'Affiliation': 'Department of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'Department of Internal Medicine, Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Taco W', 'Initials': 'TW', 'LastName': 'Kuijpers', 'Affiliation': ""Department of Paediatric Immunology and Infectious Diseases, Emma Children's Hospital, AUMC, University of Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Joris M', 'Initials': 'JM', 'LastName': 'van Montfrans', 'Affiliation': 'Department of Pediatric Immunology and Infectious Diseases, UMC Utrecht, Lundlaan 6, 3584 EA, Utrecht, The Netherlands. j.vanmontfrans@umcutrecht.nl.'}]",Journal of clinical immunology,['10.1007/s10875-020-00841-3']
2350,33206263,"Early ART Initiation Improves HIV Status Disclosure and Social Support in People Living with HIV, Linked to Care Within a Universal Test and Treat Program in Rural South Africa (ANRS 12249 TasP Trial).","We investigated the effect of early antiretroviral treatment (ART) initiation on HIV status disclosure and social support in a cluster-randomized, treatment-as-prevention (TasP) trial in rural South Africa. Individuals identified HIV-positive after home-based testing were referred to trial clinics where they were invited to initiate ART immediately irrespective of CD4 count (intervention arm) or following national guidelines (control arm). We used Poisson mixed effects models to assess the independent effects of (a) time since baseline clinical visit, (b) trial arm, and (c) ART initiation on HIV disclosure (n = 182) and social support (n = 152) among participants with a CD4 count > 500 cells/mm 3  at baseline. Disclosure and social support significantly improved over follow-up in both arms. Disclosure was higher (incidence rate ratio [95% confidence interval]: 1.24 [1.04; 1.48]), and social support increased faster (1.22 [1.02; 1.46]) in the intervention arm than in the control arm. ART initiation improved both disclosure and social support (1.50 [1.28; 1.75] and 1.34 [1.12; 1.61], respectively), a stronger effect being seen in the intervention arm for social support (1.50 [1.12; 2.01]). Besides clinical benefits, early ART initiation may also improve psychosocial outcomes. This should further encourage countries to implement universal test-and-treat strategies.",2020,"ART initiation improved both disclosure and social support (1.50 [1.28; 1.75] and 1.34 [1.12; 1.61], respectively), a stronger effect being seen in the intervention arm for social support (1.50 [1.12; 2.01]).","['People', 'Rural South Africa', 'Living with HIV, Linked to Care', 'rural South Africa', 'HIV disclosure (n\xa0=\xa0182) and social support (n\xa0=\xa0152) among participants with a CD4 count\xa0>\xa0500 cells/mm 3  at baseline', 'Individuals identified HIV-positive after home-based testing were referred to trial clinics']",['early antiretroviral treatment (ART) initiation'],"['ART initiation improved both disclosure and social support', 'Disclosure and social support', 'HIV Status Disclosure and Social Support']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",,0.212545,"ART initiation improved both disclosure and social support (1.50 [1.28; 1.75] and 1.34 [1.12; 1.61], respectively), a stronger effect being seen in the intervention arm for social support (1.50 [1.12; 2.01]).","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Fiorentino', 'Affiliation': ""Aix Marseille Univ, UMR912 - INSERM, IRD, SanteRCom, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Faculté de Médecine, 27 bd Jean Moulin, 13005, Marseille, France. marion.fiorentino@inserm.fr.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Nishimwe', 'Affiliation': ""Aix Marseille Univ, UMR912 - INSERM, IRD, SanteRCom, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Faculté de Médecine, 27 bd Jean Moulin, 13005, Marseille, France.""}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Protopopescu', 'Affiliation': ""Aix Marseille Univ, UMR912 - INSERM, IRD, SanteRCom, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Faculté de Médecine, 27 bd Jean Moulin, 13005, Marseille, France.""}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Nonhlanhla', 'Initials': 'N', 'LastName': 'Okesola', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Spire', 'Affiliation': ""Aix Marseille Univ, UMR912 - INSERM, IRD, SanteRCom, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Faculté de Médecine, 27 bd Jean Moulin, 13005, Marseille, France.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dabis', 'Affiliation': 'INSERM, UMR1219 Bordeaux Population Health Research Center, Université de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Ceped UMR 196, Université Paris Descartes Inserm, Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Boyer', 'Affiliation': ""Aix Marseille Univ, UMR912 - INSERM, IRD, SanteRCom, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Faculté de Médecine, 27 bd Jean Moulin, 13005, Marseille, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-020-03101-y']
2351,33206268,The Effects of Aquatic Versus Kata Techniques Training on Static and Dynamic Balance in Children with Autism Spectrum Disorder.,"The present study aimed to compare the effect of a land-based and a swimming-based exercise program on balance abilities in children with autism. Thirty children were voluntarily selected and randomly assigned to karate exercise, aquatic training and control groups. Participants practiced for 10 weeks, 2 sessions of 60 min per week. Before and after the 10-week intervention, static and dynamic balance tests were administered. The results showed that both interventions had a significant effect on balance abilities (p < 0.001); interestingly, we found the greater improvement in balance performance in kata techniques group. Due to the importance of balance performance on daily functions, communication and interaction skills, karate and swimming exercises can be the valuable interventions added to autism's daily programs. Iranian Registry of Clinical Trials number: IRCT20180626040242N1.",2020,"The results showed that both interventions had a significant effect on balance abilities (p < 0.001); interestingly, we found the greater improvement in balance performance in kata techniques group.","['Children with Autism Spectrum Disorder', 'children with autism', 'Thirty children']","['land-based and a swimming-based exercise program', 'Aquatic Versus Kata Techniques Training', 'karate exercise, aquatic training and control groups']","['balance performance', 'Static and Dynamic Balance', 'balance abilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C0079654', 'cui_str': 'Karate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}]",30.0,0.0267585,"The results showed that both interventions had a significant effect on balance abilities (p < 0.001); interestingly, we found the greater improvement in balance performance in kata techniques group.","[{'ForeName': 'Soleyman', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'PhD of Exercise Physiology, Department of Physical Education, Rasht Branch, Islamic Azad University, Rasht, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Hosseinkhanzadeh', 'Affiliation': 'Department of Psychology, Faculty of Literature and Humanities, University of Guilan, Rasht, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'AdibSaber', 'Affiliation': 'Department of Physical Education, Rasht Branch, Islamic Azad University, Rasht, Iran. adibsaber@iaurasht.ac.ir.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Shojaei', 'Affiliation': 'Department of Motor Behavior, Faculty of Physical Education and Sport Sciences, Alzahra University, Tehran, Iran.'}, {'ForeName': 'Afkham', 'Initials': 'A', 'LastName': 'Daneshfar', 'Affiliation': 'Department of Motor Behavior, Faculty of Physical Education and Sport Sciences, Alzahra University, Tehran, Iran.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04785-w']
2352,33206270,Efficacy of Pregabalin and Antioxidants Combination in Reducing Pain in Chronic Pancreatitis: A Double Blind Randomized Trial.,"BACKGROUND


In patients with chronic pancreatitis (CP), pain relief is a dilemma. Antioxidants with pregabalin therapy have been reported to be useful. Hence, this study was carried out to determine the efficacy of the combination of antioxidant and pregabalin therapy in reducing pain in patients with CP.
METHODS


This was a prospective, double blind, superiority, and randomized trial in patients with CP. The treatment group received pregabalin with antioxidants therapy for 8 weeks, and a similar placebo was administered to the controls. Primary outcome was to determine the change in maximum pain intensity assessed by visual analog scale (VAS) and Izbicki pain score. Secondary outcomes were the number of painful days, opioid and non-opioid requirements, improvement in quality of life, number of hospital admission, and overall patient satisfaction.
RESULTS


A total of 90 patients were randomized to 45 in each arm. Demographic profile and baseline pain score were comparable. Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively. Significant proportion of patients was satisfied in the treatment group compared to placebo group (18% vs. 11%; p = 0.03).
CONCLUSION


The combination of pregabalin and antioxidant significantly reduces the pain, requirement of non-opioid analgesics, and the number of hospital admissions in patients with CP. It also significantly improves the overall patient satisfaction.
CLINICAL TRIALS REGISTER NUMBER


CTRI/2017/05/008492.",2020,"Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively.","['Chronic Pancreatitis', 'patients with chronic pancreatitis (CP', 'A total of 90 patients', 'patients with CP']","['antioxidant and pregabalin therapy', 'Pregabalin and Antioxidants Combination', 'Antioxidants with pregabalin therapy', 'placebo', 'pregabalin with antioxidants therapy', 'pregabalin and antioxidant']","['non-opioid analgesic requirement', 'number of hospital admissions', 'pain intensity', 'overall patient satisfaction', 'pain, requirement of non-opioid analgesics', 'Demographic\xa0profile and baseline pain score', 'change in maximum pain intensity assessed by visual analog scale (VAS) and Izbicki pain score', 'number of painful days, opioid and non-opioid requirements, improvement in quality of life, number of hospital admission, and overall patient satisfaction']","[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1879713', 'cui_str': 'Antioxidant therapy'}]","[{'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",90.0,0.555588,"Patients in treatment group when compared to placebo group had a significant reduction in pain intensity (VAS score 2 ± 0.8 vs. 1.3 ± 0.9; p = 0.007), non-opioid analgesic requirement in days (54.4±2.9 vs. 55.7±1.5; p = 0.014), and number of hospital admissions (0.2 ± 0.5 vs. 0.6 ± 0.7; p = 0.002), respectively.","[{'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Agrawal', 'Initials': 'A', 'LastName': 'Omang', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Amaranathan', 'Initials': 'A', 'LastName': 'Anandhi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Rajesh', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Abdulbasith', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Chellappa', 'Initials': 'C', 'LastName': 'Vijayakumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Chinnakali', 'Initials': 'C', 'LastName': 'Palanivel', 'Affiliation': 'Department of PSM, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Pazhanivel', 'Affiliation': 'Department of Medical Gastroenterology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605006, India. drvikramkate@gmail.com.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06711-7']
2353,33210113,Staged management of cardiac disease and concomitant early lung cancer: a 20-year single-center experience.,"OBJECTIVES


The association of unstable heart disease and resectable lung cancer is rare. The impacts of staged management, cardiac surgery with cardiopulmonary bypass (CPB) versus angioplasty, on long-term survival and cancer recurrence remain debated. We report our experience using staged management.
METHODS


From 1997 to 2016, 107 patients were treated at the Quebec Heart and Lung Institute: 72 underwent cardiac surgery with CPB (group 1), 35 were treated with angioplasty (group 2), followed by oncological pulmonary resection.
RESULTS


Two postoperative deaths (3%) and 1 ischaemic heart complication (1%) were reported in group 1. One death (3%) was reported in group 2. Two-year overall survival was 82% (59/72) in group 1 and 80% (28/35) in group 2; 5-year overall survival was 62% (33/53) in group 1 and 63% (19/30) in group 2. Two-year disease-free survival in group 1 was 79% (57/72) and 77% (27/35) in group 2; 5-year disease-free survival was 58% (31/53) in group 1 and 60% (18/30) in group 2. The independent risk factors for death after thoracic surgery were transfusions (P = 0.004) and grade ≥3 complications (P = 0.034). Independent risk factors for recurrence included the cancer stage (P < 0.001) and, paradoxically, a shorter delay between cardiac and lung procedures (P = 0.031).
CONCLUSIONS


When a staged management remains feasible after cardiac procedure, oncological outcomes of patients with cardiopathy and lung cancer are satisfactory. CPB does not seem to be deleterious. The delay between procedures should intuitively be as small as possible but not at the expense of good recovery after the cardiac procedure.",2020,Two-year overall survival was 82% (59/72) in group 1 and 80% (28/35) in group 2; 5-year overall survival was 62% (33/53) in group 1 and 63% (19/30) in group 2.,"['From 1997 to 2016, 107 patients were treated at the Quebec Heart and Lung Institute: 72 underwent cardiac surgery with CPB (group 1', 'cardiac disease and concomitant early lung cancer', 'patients with cardiopathy and lung cancer']","['cardiac surgery with cardiopulmonary bypass (CPB) versus angioplasty', 'oncological pulmonary resection', 'angioplasty']","['postoperative deaths', '5-year overall survival', 'ischaemic heart complication', 'grade ≥3 complications', '5-year disease-free survival', 'overall survival']","[{'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0277599', 'cui_str': 'Postoperative death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",107.0,0.0677704,Two-year overall survival was 82% (59/72) in group 1 and 80% (28/35) in group 2; 5-year overall survival was 62% (33/53) in group 1 and 63% (19/30) in group 2.,"[{'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Tricard', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Milad', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Anaëlle', 'Initials': 'A', 'LastName': 'Chermat', 'Affiliation': 'Thoracic and Cardiovascular Surgery Department, Limoges University Hospital Center, Limoges, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Simard', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lacasse', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dagenais', 'Affiliation': 'Cardiac Surgery Department, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Conti', 'Affiliation': 'Division of Thoracic Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa360']
2354,33210186,Photobiomodulation promotes neural regeneration when compared to simvastatin treatment in a sciatic nerve crush model.,"To determine whether the effects of photobiomodulation (PBM) were associated with the use of Simvastatin in the functional recovery from sciatic nerve in mice submitted to crush injury. Fifty Swiss mice (approximately 3 months old; average weight 40 g) were randomly divided into six groups: naive, sham, control, PBM (660 nm, 10 J/cm 2 ; 30 mW; 0.6 J per day for 28 days; 0.06 cm 2 ; 16.8 J total and 20 s), Simvastatin (20 mg/kg), and PBM/Simv (association of the two protocols). The sciatic functional index (SFI), thermal heat hyperalgesia, mechanical hyperalgesia, and thermographic evaluation were used as analyses. The evaluations were performed preoperatively and 7, 14, 21, and 28 days after the initial injury analyzed by two-way analysis of variance (ANOVA) for mixed models followed by the Bonferroni post-test. All groups except sham and naive presented an SFI compatible with severe peripheral nerve injury on the 7th day of evaluation. The PBM group presented better results in the SFI analysis (p < 0.001) on the 21st postoperative day compared to the control group. This benefit was maintained when compared to the Simvastatin (p < 0.001) and PBM/Simv groups (p < 0.01). The results of the thermal and mechanical hyperalgesia and thermography analyses were not significant (p > 0.05). The obtained results showed that PBM alone was more effective compared to Simvastatin alone or PBM combined with Simvastatin for sciatic nerve injury in mice.",2020,The PBM group presented better results in the SFI analysis (p < 0.001) on the 21st postoperative day compared to the control group.,['Fifty Swiss mice (approximately 3\xa0months old; average weight 40\xa0g'],"['simvastatin', 'Simvastatin', 'photobiomodulation (PBM', 'PBM']","['thermal and mechanical hyperalgesia and thermography analyses', 'sciatic functional index (SFI), thermal heat hyperalgesia, mechanical hyperalgesia, and thermographic evaluation']","[{'cui': 'C0162416', 'cui_str': 'Swiss Mice'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C0039810', 'cui_str': 'Thermography'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.0313582,The PBM group presented better results in the SFI analysis (p < 0.001) on the 21st postoperative day compared to the control group.,"[{'ForeName': 'Luana Gabriel', 'Initials': 'LG', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Federal University of Santa Catarina/UFSC, Araranguá, Brazil.'}, {'ForeName': 'Ketlyn Germann', 'Initials': 'KG', 'LastName': 'Hendler', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Federal University of Santa Catarina/UFSC, Araranguá, Brazil.'}, {'ForeName': 'Alexandre Márcio', 'Initials': 'AM', 'LastName': 'Marcolino', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Federal University of Santa Catarina/UFSC, Araranguá, Brazil.'}, {'ForeName': 'Heloyse Uliam', 'Initials': 'HU', 'LastName': 'Kuriki', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Federal University of Santa Catarina/UFSC, Araranguá, Brazil.'}, {'ForeName': 'Ramon Bauer', 'Initials': 'RB', 'LastName': 'Cardoso', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Federal University of Santa Catarina/UFSC, Araranguá, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'de Cássia Registro Fonseca', 'Affiliation': 'Postgraduate Program in Functional Rehabilitation and Performance, University of São Paulo USP, Ribeirão Preto, Brazil.'}, {'ForeName': 'Rafael Inácio', 'Initials': 'RI', 'LastName': 'Barbosa', 'Affiliation': 'Postgraduate Program in Rehabilitation Sciences, Federal University of Santa Catarina/UFSC, Araranguá, Brazil. rafael.barbosa@ufsc.br.'}]",Lasers in medical science,['10.1007/s10103-020-03176-y']
2355,33210192,Impact of Metformin on Statin Persistence: a Post Hoc Analysis of a Large Randomized Controlled Trial.,,2020,,[],['Metformin'],['Statin Persistence'],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]",,0.194436,,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Cheon', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsalatsanis', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cowart', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Magness', 'Affiliation': 'Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Srinivas M', 'Initials': 'SM', 'LastName': 'Tipparaju', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA.'}, {'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Carris', 'Affiliation': 'Taneja College of Pharmacy, University of South Florida, 12901 Bruce B Downs Blvd., MDC 30, Tampa, FL, 33612, USA. carris@usf.edu.'}]",Journal of general internal medicine,['10.1007/s11606-020-06344-6']
2356,33210266,Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials.,"INTRODUCTION


Use of parenteral opioids is a major risk factor for postoperative nausea and vomiting. Conventional opioids bind to µ-opioid receptors (MOR), stimulate both the G-protein signaling (achieving analgesia); and the β-arrestin pathway (associated with opioid-related adverse effects). Oliceridine, a next-generation IV opioid, is a G-protein selective MOR agonist, with limited recruitment of β-arrestin. In two randomized, placebo- and morphine-controlled phase 3 studies of patients with moderate-to-severe acute pain following bunionectomy or abdominoplasty, oliceridine at demand doses of 0.1, 0.35, and 0.5 mg provided rapid and sustained analgesia vs. placebo with favorable gastrointestinal (GI) tolerability. In this exploratory analysis, we utilized a clinical endpoint assessing gastrointestinal tolerability, ""complete GI response"" defined as the proportion of patients with no vomiting and no use of rescue antiemetic to characterize the GI tolerability profile of oliceridine vs. morphine.
METHODS


A logistic regression model was utilized to compare oliceridine (pooled regimens) vs. morphine, after controlling for analgesia (using the sum of pain intensity difference [SPID]-48/24 [bunionectomy/abdominoplasty] with pre-rescue scores carried forward for 6 h). This analysis excluded patients receiving placebo and was performed for each study separately and for pooled data from both studies.
RESULTS


In the unadjusted analysis, a significantly greater proportion of patients in the placebo (76.4%), oliceridine 0.1 mg (68.0%), and 0.35 mg (46.2%) demand dose achieved complete GI response vs. morphine 1 mg (30.8%), p ≤ 0.005. In the adjusted analysis, after controlling for analgesia, the odds ratio of experiencing a complete GI response with oliceridine (pooled regimens) vs. morphine was 3.14 (95% CI: 1.78, 5.56; p < 0.0001) in bunionectomy study and 1.92 (95% CI: 1.09, 3.36; p = 0.024) in abdominoplasty study.
CONCLUSIONS


When controlled for the analgesic effects (constant SPID-48/24), the odds ratio for complete GI response was higher with oliceridine than morphine, suggesting better GI tolerability with oliceridine.",2020,"demand dose achieved complete GI response vs. morphine 1 mg (30.8%), p ≤ 0.005.",['patients with moderate-to-severe acute pain following'],"['bunionectomy or abdominoplasty, oliceridine', 'Oliceridine', 'oliceridine vs. morphine', 'rapid and sustained analgesia vs. placebo', 'placebo', 'Morphine', 'oliceridine', 'morphine', 'Placebo']","['odds ratio of experiencing a complete GI response', 'favorable gastrointestinal (GI) tolerability', 'odds ratio for complete GI response', 'GI tolerability', 'complete GI response', 'Risk of Vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]","[{'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.370915,"demand dose achieved complete GI response vs. morphine 1 mg (30.8%), p ≤ 0.005.","[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Beard', 'Affiliation': 'Department of Surgery and Clinical Research, Summit Medical Group, Bend Memorial Clinic, Bend, OR, USA. tbeard@bendbroadband.com.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Trevena, Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Candiotti', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine, and Pain Management, University of Miami, Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rider', 'Affiliation': 'Department of Surgery, University of South Alabama Medical Center, Mobile, AL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Trevena, Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Habib', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Trevena, Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Trevena, Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Viscusi', 'Affiliation': 'Department of Anesthesiology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Pain and therapy,['10.1007/s40122-020-00216-x']
2357,33210278,Effectiveness of a 4-week sophrology program for primary care patients with moderate to high anxiety levels: a randomised controlled trial.,he aim of this study is to determine the effectiveness of an intensive four-week structured group re- laxation-training program (sophrology&#8217;s dynamic relaxation) on anxiety and depression symptoms in primary care patients with moderate and high anxiety levels.,2020,he aim of this study is to determine the effectiveness of an intensive four-week structured group re- laxation-training program (sophrology&#8217;s dynamic relaxation) on anxiety and depression symptoms in primary care patients with moderate and high anxiety levels.,"['primary care patients with moderate and high anxiety levels', 'primary care patients with moderate to high anxiety levels']","['4-week sophrology program', 'intensive four-week structured group re- laxation-training program (sophrology&#8217;s dynamic relaxation']",['anxiety and depression symptoms'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0184033,he aim of this study is to determine the effectiveness of an intensive four-week structured group re- laxation-training program (sophrology&#8217;s dynamic relaxation) on anxiety and depression symptoms in primary care patients with moderate and high anxiety levels.,"[{'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'van Rangelrooij', 'Affiliation': 'Department of Psychiatry and Forensic Medicine, Autonomous University of Barcelona, Spain Sofrocay, Academy for Caycedian sophrology, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Solans-Buxeda', 'Affiliation': 'Sofrocay, Academy for Caycedian sophrology, Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fernández-García', 'Affiliation': 'Sofrocay, Academy for Caycedian sophrology, Barcelona, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Caycedo-Desprez', 'Affiliation': 'Sofrocay, Academy for Caycedian sophrology, Barcelona, Spain.'}, {'ForeName': 'Rejina', 'Initials': 'R', 'LastName': 'Selvam', 'Affiliation': 'Adaptive Behavior and Interaction Research Group, PSICOSAO, Department of Quantitative and Social Psychology, University of Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bulbena', 'Affiliation': 'INAD. Parc de Salud Mar. Department of Psychiatry and Forensic Medicine, Autonomous University of Barcelona, Spain.'}]",Actas espanolas de psiquiatria,[]
2358,33207656,Comparative Analysis of Root Canal Filling Debris and Smear Layer Removal Efficacy Using Various Root Canal Activation Systems during Endodontic Retreatment.,"The complete removal of obturation material can be a challenge in nonsurgical root canal retreatment. The insufficient removal of obturation material is a reason for root canal retreatment failure. The purpose of this study was to assess the efficacy of different final root canal irrigation activation methods in removing debris and smear layers in the apical and middle portions of root canals during retreatment. Sixty-six distal roots of freshly extracted molars were randomly divided into six groups: (1) primary root canal treatment with no obturation (negative control); (2) retreatment with only conventional instrumentation and irrigation (positive control); (3) retreatment with additional ultrasonic irrigation using the Piezon Master 700; (4) ultrasonic irrigation with the ENDOSONIC Blue; (5) sonic irrigation with the EDDY; and (6) multisonic irrigation with the GentleWave system. Roots were split and prepared for scanning electron microscopic (SEM) evaluation. Acquired images were assessed to quantify the amount of debris and smear remaining. Among the treatment groups, Group 6 had a significantly lower debris score than Group 2 (positive control) in both the middle and apical regions ( p  = 0.004,  p  = 0.012). All treatment groups showed significantly lower smear scores than Group 2 in the middle and apical regions ( p  < 0.05). The GentleWave multisonic System showed a more optimal cleaning efficacy of the root canal debris but did not differ significantly with the tested passive ultrasonic or sonic irrigation method.",2020,The GentleWave multisonic System showed a more optimal cleaning efficacy of the root canal debris but did not differ significantly with the tested passive ultrasonic or sonic irrigation method.,['Sixty-six distal roots of freshly extracted molars'],"['primary root canal treatment with no obturation (negative control); (2) retreatment with only conventional instrumentation and irrigation (positive control); (3) retreatment with additional ultrasonic irrigation using the Piezon Master 700; (4) ultrasonic irrigation with the ENDOSONIC Blue; (5) sonic irrigation with the EDDY; and (6) multisonic irrigation with the GentleWave system', 'Root Canal Filling Debris and Smear Layer Removal Efficacy Using Various Root Canal Activation Systems']","['debris score', 'smear scores']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0447373', 'cui_str': 'Distal tooth root'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]",,0.0198792,The GentleWave multisonic System showed a more optimal cleaning efficacy of the root canal debris but did not differ significantly with the tested passive ultrasonic or sonic irrigation method.,"[{'ForeName': 'Seong Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, College of Dentistry, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Mo Kwan', 'Initials': 'MK', 'LastName': 'Kang', 'Affiliation': 'Department of Endodontics, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Choi', 'Affiliation': 'Department of Dental Biomaterials Science, School of Dentistry, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Won-Jun', 'Initials': 'WJ', 'LastName': 'Shon', 'Affiliation': 'Department of Conservative Dentistry, College of Dentistry, Seoul National University, Seoul 08826, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110615']
2359,33207670,Effects of Virtual Reality on Cardiac Rehabilitation Programs for Ischemic Heart Disease: A Randomized Pilot Clinical Trial.,"(1) Background: The aim of the present study was to determine the effects of a virtual reality (VR) program, as a complementary tool to a conventional cardiac rehabilitation (CR) program in phase II of patients with ischemic heart disease compared to a conventional treatment group. (2) Methods: A single blinded randomized clinical trial was conducted. The patients were randomized to a control group (CG) or an experimental group (EG). The EG carried out a training based on VR of aerobic exercise using the XBOX ONE console and Kinect sensor. Ergometry, metabolic equivalents (METS), Functional Independence Measure, 6-min walk test (6MWT), the Short Form Health Survey-36 Questionnaire (SF-36), the Beck Depression Inventory-II, and the degree of satisfaction and adherence to treatment were used as outcome measures. (3) Results: Our results showed no statistically significant differences between the two groups. Statistical analysis within group for the EG showed statistically significant changes in the variables HR final ergometry, ergometry minutes, % ergometry, METS, final HR 6MWT, 6MWT distance, 6MWT number of laps, and for the SF-36 and Beck Depression Inventory-II. (4) Conclusion: A VR-based video game program, as an adjunct tool to a CR program, showed improvements in ergometry, METS, resistance to fatigue and health-related quality of life with excellent adherence and satisfaction perceived by patients with ischemic heart disease in phase II.",2020,Our results showed no statistically significant differences between the two groups.,"['patients with ischemic heart disease in phase II', 'Ischemic Heart Disease', 'patients with ischemic heart disease compared to a conventional treatment group']","['VR-based video game program', 'Virtual Reality', 'control group (CG', 'conventional cardiac rehabilitation (CR) program', 'virtual reality (VR) program']","['variables HR final ergometry, ergometry minutes, % ergometry, METS, final HR 6MWT, 6MWT distance, 6MWT number of laps, and for the SF-36 and Beck Depression Inventory-II', 'ergometry, METS, resistance to fatigue and health-related quality of life with excellent adherence and satisfaction', 'Ergometry, metabolic equivalents (METS), Functional Independence Measure, 6-min walk test (6MWT), the Short Form Health Survey-36 Questionnaire (SF-36), the Beck Depression Inventory-II, and the degree of satisfaction and adherence to treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0376413,Our results showed no statistically significant differences between the two groups.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'García-Bravo', 'Affiliation': 'International Doctorate School, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Domínguez-Paniagua', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Campuzano-Ruiz', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Barreñada-Copete', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'López-Navas', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Araujo-Narváez', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'García-Bravo', 'Affiliation': 'International Doctorate School, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Florez-Garcia', 'Affiliation': 'Rehabilitation Service, Hospital Universitario Fundación Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Botas-Rodríguez', 'Affiliation': 'Cardiology Service, Hospital Universitario Fundación Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Cuesta-Gómez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Rey Juan Carlos University, 28922 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228472']
2360,33207693,"How Volatile Compounds, Oxidative Profile and Sensory Evaluation Can Change with Vacuum Aging in Donkey Meat.","This study aims to improve knowledge on donkey meat and the vacuum aging effect on the Volatile Organic Compounds (VOCs), oxidative profile and status and the sensory characteristics. Ten 18-month old Martina Franca donkeys' male foals were involved in the trial.  Longissimus thoracis  (LT) muscle was extracted from each left half carcass, between the fourth and the ninth rib. Each muscle was divided into five sections, vacuum packaged, stored at 2 °C, and randomly assigned to one of the different aging time (1, 3, 6, 9, and 14 days of aging). Volatile compounds, oxidation parameters, and antioxidant enzymes were analysed, and a sensory test was performed. A nested one-way analysis of variance (ANOVA) was performed for aging time as an independent variable. Significance was set at  p  < 0.05. Aldehydes are the most produced VOCs, but no changes were observed during vacuum aging ( p  > 0.05). Nitrogen compounds increased during aging ( p  < 0.01). TBARs and hydroperoxides did not change during the storage, whereas the protein carbonyls increased ( p  < 0.05). Vacuum aging slowed down lipid oxidation and put in evidence the presence of protein oxidation and degradation, influencing the VOCs productions and sensory evaluation.",2020,"Aldehydes are the most produced VOCs, but no changes were observed during vacuum aging ( p  > 0.05).","[""Ten 18-month old Martina Franca donkeys' male foals were involved in the trial""]",[],"['Volatile compounds, oxidation parameters, and antioxidant enzymes', 'protein carbonyls', 'Volatile Organic Compounds (VOCs), oxidative profile and status and the sensory characteristics', 'TBARs and hydroperoxides']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0324145', 'cui_str': 'Equus asinus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]",,0.0287915,"Aldehydes are the most produced VOCs, but no changes were observed during vacuum aging ( p  > 0.05).","[{'ForeName': 'Aristide', 'Initials': 'A', 'LastName': 'Maggiolino', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Lorenzo', 'Affiliation': 'Centro Tecnológico de la Carne de Galicia, Parque Tecnológico de Galicia, 32900 Ourense, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Centoducati', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Domínguez', 'Affiliation': 'Centro Tecnológico de la Carne de Galicia, Parque Tecnológico de Galicia, 32900 Ourense, Spain.'}, {'ForeName': 'Francesca Rita', 'Initials': 'FR', 'LastName': 'Dinardo', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Marino', 'Affiliation': 'Department of Agricultural Food and Environmental Sciences, University of Foggia, 71121 Foggia, Italy.'}, {'ForeName': 'Antonella Della', 'Initials': 'AD', 'LastName': 'Malva', 'Affiliation': 'Department of Agricultural Food and Environmental Sciences, University of Foggia, 71121 Foggia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bragaglio', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'De Palo', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}]",Animals : an open access journal from MDPI,['10.3390/ani10112126']
2361,33207743,"Administration of an Intravenous Fat Emulsion Enriched with Medium-Chain Triglyceride/ω-3 Fatty Acids is Beneficial Towards Anti-Inflammatory Related Fatty Acid Profile in Preterm Neonates: A Randomized, Double-Blind Clinical Trial.","Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. We aimed to investigate the effects of a medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile and serum interleukin-6 (IL-6) in preterm neonates. In this double-blind randomized study, 92 preterm neonates (gestational age < 32 weeks, birth weight < 1500 g) were assigned to receive either MCT/ω-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry. Serum IL-6 was measured with sandwich ELISA in 59 neonates. Plasma FAs changed significantly over time; the MCT/ω-3 PUFA-IVFE group showed higher ω-3 PUFAs ( p  = 0.031), eicosapentaenoic acid ( p  = 0.000), and oleic acid ( p  = 0.003), and lower ω-6/ω-3 PUFAs ratio ( p  = 0.001) and ω-6 PUFAs ( p  = 0.023) compared to control group. Linoleic acid was higher in the soybean oil (SO)-based IVFE arm compared to the MCT/ω-3 PUFAs-IVFE arm ( p  = 0.006). Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups. Administration of MCT/ω-3 PUFA-enriched IVFE in preterm neonates is beneficial in changing the FA profile consistent with attenuated inflammatory response.",2020,"Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups.","['preterm neonates', 'Preterm Neonates', '92 preterm neonates (gestational age < 32 weeks, birth weight < 1500 g', '59 neonates']","['pure soybean oil emulsions', 'MCT/ω-3 PUFA-enriched IVFE', 'MCT/ω-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group', 'soybean oil (SO)-based IVFE', 'medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE', 'MCT/ω-3 PUFA-IVFE', 'Intravenous Fat Emulsion Enriched with Medium-Chain Triglyceride/ω-3 Fatty Acids']","['Linoleic acid', 'ω-3 PUFAs', 'Levels of FAs', 'eicosapentaenoic acid', 'IL-6', 'Plasma FAs', 'lower ω-6/ω-3 PUFAs ratio', 'plasma fatty acid (FA) profile and serum interleukin-6 (IL-6', 'Serum IL-6', 'oleic acid', 'ω-6 PUFAs']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]","[{'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}]",92.0,0.664658,"Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups.","[{'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Papandreou', 'Affiliation': 'First Department of Pediatrics, Medical School, National & Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Goudi, 11527 Athens, Greece.'}, {'ForeName': 'Aristea', 'Initials': 'A', 'LastName': 'Gioxari', 'Affiliation': 'Department of Nutritional Science and Dietetics, Harokopio University, Kallithea, 17671 Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Ntountaniotis', 'Affiliation': 'Department of Chemistry, National and Kapodistrian University of Athens, Zografou, 15771 Athens, Greece.'}, {'ForeName': 'Olga-Natalia', 'Initials': 'ON', 'LastName': 'Korda', 'Affiliation': 'Department of Nutritional Science and Dietetics, Harokopio University, Kallithea, 17671 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Skouroliakou', 'Affiliation': 'Department of Nutritional Science and Dietetics, Harokopio University, Kallithea, 17671 Athens, Greece.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Siahanidou', 'Affiliation': 'First Department of Pediatrics, Medical School, National & Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Goudi, 11527 Athens, Greece.'}]",Nutrients,['10.3390/nu12113526']
2362,33207972,An hypothetical external validation of the ARRIVE trial in a European academic hospital.,"BACKGROUND


Recent evidence supports elective induction of labor at 39 weeks in low-risk pregnancies to improve maternal and perinatal outcomes. This evidence includes the ARRIVE trial (A Randomized Trial of Induction Versus Expectant Management). However, concerns have been raised on the external validity of the ARRIVE trial, especially with regard to the demographic and clinical characteristics of the pregnant women recruited.
OBJECTIVE


This study compared the outcomes in a cohort of consecutive pregnant women, who fulfilled the criteria of the ARRIVE trial and were managed expectantly in an Italian referral academic hospital, with those reported in the expectant and induction arms of the ARRIVE trial.
STUDY DESIGN


This was a retrospective single-center study. Consecutive low-risk nulliparous women who fulfilled the ARRIVE trial criteria were evaluated for eligibility at 36-38 weeks of gestation. Those who neither developed complications nor delivered spontaneously before 39 weeks were eligible for this comparative analysis. Maternal and fetal growth and wellbeing were screened and monitored from 36 to 38 weeks of gestation.
RESULTS


A total of 1696 patients met the established criteria at recruitment. Of these, 343 spontaneously delivered in <39 weeks, 82 delivered because of maternal indication, and 37 for fetal indication. A total of 1234 pregnant women were eligible for comparison with the elective induction and the expectant management groups of the ARRIVE trial. The socioeconomic status was significantly better, maternal age was significantly higher, and body mass index was significantly lower in our cohort. Cesarean section rate in our cohort was lower than that of the expectant group of the ARRIVE trial (18.7 vs. 22.2%;  p  = 0.02) and similar to that of the elective induction group (18.7 vs. 18.6%). A new diagnosis of hypertensive disorders during expectant management was noted in 1.6% in our cohort vs. 14.1% in the ARRIVE arm. Among the different obstetric outcomes, only the prevalence of postpartum hemorrhage was not significantly lower in our cohort. The primary perinatal composite outcome was significantly better in our cohort than in both arms of the ARRIVE trial (2.1 vs. 5.4% in the expectant group and 4.3% in the induction group). We did not record cases with an Apgar score ≤ 3 or hypoxic-ischemic encephalopathy.
CONCLUSION


In our cohort, expectant management in low-risk pregnancies with late preterm screening of feto-maternal well-being seemed to achieve better maternal and perinatal outcomes than a universal policy of induction at 39 weeks. The results of the ARRIVE trial should be carefully evaluated in different demographic and clinical settings and cannot be extended to the general population.",2020,"The socioeconomic status was significantly better, maternal age was significantly higher, and body mass index was significantly lower in our cohort.","['1234 pregnant women were eligible for comparison with the elective induction and the expectant management groups of the ARRIVE trial', 'consecutive pregnant women, who fulfilled the criteria of the ARRIVE trial and were managed expectantly in an Italian referral academic hospital, with those reported in the expectant and induction arms of the ARRIVE trial', 'pregnant women recruited', '1696 patients met the established criteria at recruitment', 'Consecutive low-risk nulliparous women who fulfilled the ARRIVE trial criteria were evaluated for eligibility at 36-38\u2009weeks of gestation']",[],"['prevalence of postpartum hemorrhage', 'body mass index', 'hypertensive disorders', 'Cesarean section rate', 'Maternal and fetal growth and wellbeing']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}]",1234.0,0.0849345,"The socioeconomic status was significantly better, maternal age was significantly higher, and body mass index was significantly lower in our cohort.","[{'ForeName': 'Beatrice M G', 'Initials': 'BMG', 'LastName': 'Tassis', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruggiero', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ronchi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Ilaria G', 'Initials': 'IG', 'LastName': 'Ramezzana', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bischetti', 'Affiliation': 'Humanitas San Pio X Hospital, Milano, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Iurlaro', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Ambrosi"", 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Ciralli', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Ferrazzi', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università Degli Studi di Milano, Milano, Italy.""}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1849108']
2363,33207979,Combined hereditary thrombophilias are responsible for poor placental vascularization development and low molecular weight heparins (LMWH) prevent adverse pregnancy outcomes in these patients.,"BACKGROUND


Even though thrombophilias are associated with negative pregnancy outcomes (PO), there is not a consensus of when thrombophilias should be screened for, or how they affect placental vascularization during pregnancy. Therefore, the main aim of this study was to discover inherited thrombophilias (IHT) in the first trimester in women with otherwise no indications for thrombophilia screening, based on their vascularization parameters. LMWH treatment in improvement of placental vascularization and PO was also assessed. Finally, the classification of thrombophilias based on observed obstetric risks was proposed.
METHODS


Women were included in study based on their poor gestational sac and later utero-placental juncture vascularization signal and screening for inherited thrombophilias. LMWH were then initiated and Resistance index of Uterine artery (RIAU) was followed alongside PO (preterm birth, preeclampsia, placental abruption, intrauterine growth reduction). Study group consisted of women with combined inherited thrombophilias. Control group consisted of patients with inherited thrombophilias who have received LMWH therapy since pregnancy beginning.
FINDINGS


Out of 219 women, 93 had IHT, and 43 had combined IHT. All pregnancies both in both groups ended up with live births. Vaginal birth was more present in the control group ( p  < .001), and all women in study group delivered by CS. Premature birth was present in 8.4% of patients in control group, and in 32.55% of the patients in the study ( p  < .001). PE wasn't noted, and only 1 case of PA in control group. In the control group, 6.5% patients had IUGR, and 32.55% in the study group ( p  < .05). Based on RIAU and PO, thrombophilia categories were established: S (severe), MO (moderate), MI (mild) and L (low). Higher risk thrombophilias had higher RIAU later in the pregnancy, earlier pregnancy termination and Intrauterine Growth Reduction (IUGR).
CONCLUSIONS


Thrombophilias should be considered and screened when poor vascularization is noted early in the pregnancy with Doppler sonography. Intervention with LMWH prevents adverse PO in these patients.",2020,"Vaginal birth was more present in the control group ( p  < .001), and all women in study group delivered by CS.","['Out of 219 women, 93 had IHT, and 43 had combined IHT', 'women with combined inherited thrombophilias', 'women with otherwise no indications for thrombophilia screening, based on their vascularization parameters', 'patients with inherited thrombophilias who have received LMWH therapy since pregnancy beginning', 'Women were included in study based on their poor gestational sac and later utero-placental juncture vascularization signal and screening for inherited thrombophilias']",['LMWH'],"['Vaginal birth', 'IUGR', 'RIAU and PO, thrombophilia categories were established: S (severe), MO (moderate), MI (mild) and L (low', 'pregnancy termination and Intrauterine Growth Reduction (IUGR', 'Premature birth', 'placental vascularization and PO']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0521090', 'cui_str': 'No indication of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}]",219.0,0.0571772,"Vaginal birth was more present in the control group ( p  < .001), and all women in study group delivered by CS.","[{'ForeName': 'Miroslava G', 'Initials': 'MG', 'LastName': 'Gojnic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Dugalic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Aleksandar O', 'Initials': 'AO', 'LastName': 'Stefanovic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Katarina V', 'Initials': 'KV', 'LastName': 'Stefanovic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Milos A', 'Initials': 'MA', 'LastName': 'Petronijevic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Svetlana M', 'Initials': 'SM', 'LastName': 'Vrzic Petronijevic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Igor V', 'Initials': 'IV', 'LastName': 'Pantic', 'Affiliation': 'School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Milan D', 'Initials': 'MD', 'LastName': 'Perovic', 'Affiliation': 'School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Brankica I', 'Initials': 'BI', 'LastName': 'Vasiljevic', 'Affiliation': 'Department of Maternal and Child Services, NMC Royal Hospital DOP Dubai, Dubai, United Arab Emirates.'}, {'ForeName': 'Nemanja M', 'Initials': 'NM', 'LastName': 'Milincic', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Milica M', 'Initials': 'MM', 'LastName': 'Zaric', 'Affiliation': 'School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jovana S', 'Initials': 'JS', 'LastName': 'Todorovic', 'Affiliation': 'School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Macura', 'Affiliation': 'Clinic for Gynaecology and Obstetrics, Clinical Centre of Serbia, Belgrade, Serbia.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1849116']
2364,33208010,Re: Cryoanalgesic versus EMLA® cream to reduce pain during analgesic injection in upper eyelid surgery: a randomized trial.,,2020,,['upper eyelid surgery'],['EMLA® cream'],['pain'],"[{'cui': 'C0585636', 'cui_str': 'Upper eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0943688,,"[{'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}, {'ForeName': 'Sweety Girijashankar', 'Initials': 'SG', 'LastName': 'Tiple', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Kumari', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': ""Oculoplasty and Ocular Oncology Services, Dr. Shroff's Charity Eye Hospital , New Delhi, India.""}]","Orbit (Amsterdam, Netherlands)",['10.1080/01676830.2020.1846762']
2365,33208014,"Effect of external diaphragmatic pacing therapy on patients with chronic cor pulmonale: a randomized, controlled trial.","OBJECTIVES


This study aimed to evaluate the effects of external diaphragmatic pacing (EDP) on patients with chronic cor pulmonale (CCP).
METHODS


Fifty patients with CCP were enrolled in Kashgar Prefecture Second People's Hospital in Xinjiang Uygur Autonomous Region of China from 2016 to 2017. The patients were randomized into a group that received anti-CCP therapy (negative control group) or a group that received additional EDP treatment (EDP group). We recorded and compared maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), FEV1/FVC, and the 6-minute walking test between the two groups on the first and tenth days of treatment.
RESULTS


Ten days after treatment began, MIP, FVC, and the 6-minute walking test were significantly improved in both groups. Importantly, MIP and FVC were significantly higher in the EDP group compared with the control group on the tenth day.
CONCLUSION


In addition to treatment for CCP, these patients can obtain extra benefit by using EDP treatment.",2020,"Ten days after treatment began, MIP, FVC, and the 6-minute walking test were significantly improved in both groups.","['Fifty patients with CCP were enrolled in Kashgar Prefecture', 'patients with chronic cor pulmonale', 'patients with chronic cor pulmonale (CCP', ""Second People's Hospital in Xinjiang Uygur Autonomous Region of China from 2016 to 2017""]","['external diaphragmatic pacing therapy', 'anti-CCP therapy (negative control group) or a group that received additional EDP treatment (EDP group', 'external diaphragmatic pacing (EDP', 'EDP']","['MIP and FVC', '6-minute walking test', 'maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), forced expiratory volume in 1\u2009s (FEV1), forced vital capacity (FVC), FEV1/FVC, and the 6-minute walking test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238074', 'cui_str': 'Chronic pulmonary heart disease'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0238074', 'cui_str': 'Chronic pulmonary heart disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",50.0,0.0570659,"Ten days after treatment began, MIP, FVC, and the 6-minute walking test were significantly improved in both groups.","[{'ForeName': 'Yongchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.""}, {'ForeName': 'Nuer Maimaiti', 'Initials': 'NM', 'LastName': 'Abula', 'Affiliation': ""Emergency Department, Kashgar Prefecture Second People's Hospital, Kashgar, Xinjiang, China.""}, {'ForeName': 'Qixing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.""}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Tong', 'Affiliation': ""Emergency Department, Kashgar Prefecture Second People's Hospital, Kashgar, Xinjiang, China.""}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Critical Care Medicine, Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.""}, {'ForeName': 'Aisikaer', 'Initials': 'A', 'LastName': 'Aisha', 'Affiliation': ""Emergency Department, Kashgar Prefecture Second People's Hospital, Kashgar, Xinjiang, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, Shanghai Tenth People's Hospital, Tongji University, Shanghai, China.""}]",The Journal of international medical research,['10.1177/0300060520965839']
2366,33208019,Twenty-Four-Hour Cardiovascular Effects of Electronic Cigarettes Compared With Cigarette Smoking in Dual Users.,"Background Cardiovascular safety is an important consideration regarding the benefits versus risks of electronic cigarette use (EC) for public health. The single-use cardiovascular effects of EC have been well studied but may not reflect effects of ad libitum use throughout the day. We aimed to compare the circadian hemodynamic effects as well as 24-hour biomarkers of oxidative stress, and platelet aggregation and inflammation, with ad libitum cigarette smoking (CS) versus EC versus no tobacco product use. Methods and Results Thirty-six healthy dual CS and EC users participated in a crossover study in a confined research setting. Circadian heart rate, blood pressure and plasma nicotine levels, 24-hour urinary catecholamines, 8-isoprostane and 11-dehydro-thromboxane B2, and plasma interleukin-6 and interleukin-8 were compared in CS, EC, and no nicotine conditions. Over 24 hours, and during daytime, heart rate and blood pressure were higher in CS and EC compared with no tobacco product conditions ( P <0.01). Heart rate on average was higher with CS versus EC. Urinary catecholamines, 8-isoprostane, and 11-dehydro-thromboxane B2 were not significantly different, but plasma IL-6 and IL-8 were higher with both CS and EC compared with no tobacco product ( P <0.01). Conclusions CS and EC had similar 24-hour patterns of hemodynamic effects compared with no tobacco product, with a higher average heart rate with CS versus EC, and similar effects on biomarkers of inflammation. EC may pose some cardiovascular risk, particularly to smokers with underlying cardiovascular disease, but may also provide a harm reduction opportunity for smokers willing to switch entirely to EC. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02470754.",2020,"Over 24 hours, and during daytime, heart rate and blood pressure were higher in CS and EC compared with no tobacco product conditions ( P <0.01).","['smokers with underlying cardiovascular disease', 'Thirty-six healthy dual CS and EC users participated in a crossover study in a confined research setting']","['Electronic Cigarettes', 'ad libitum cigarette smoking (CS) versus EC', 'EC']","['circadian hemodynamic effects', 'plasma IL-6 and IL-8', 'daytime, heart rate and blood pressure', 'hemodynamic effects', 'Circadian heart rate, blood pressure and plasma nicotine levels, 24-hour urinary catecholamines, 8-isoprostane and 11-dehydro-thromboxane B2, and plasma interleukin-6 and interleukin-8', 'Heart rate', 'Urinary catecholamines, 8-isoprostane, and 11-dehydro-thromboxane B2']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4280017', 'cui_str': 'Electronic Cigarette Use'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4280017', 'cui_str': 'Electronic Cigarette Use'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0044728', 'cui_str': '11-dehydro-thromboxane B2'}]",36.0,0.0831907,"Over 24 hours, and during daytime, heart rate and blood pressure were higher in CS and EC compared with no tobacco product conditions ( P <0.01).","[{'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Junfeng Jim', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Global Health Institute & Nicholas School of the Environment Duke University Durham NC.'}, {'ForeName': 'Arit M', 'Initials': 'AM', 'LastName': 'Harvanko', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Calfee', 'Affiliation': 'Division of Pulmonary Critical Care Allergy and Sleep Medicine Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017317']
2367,33210285,A double-blind randomized trial on subendometrial injection of vasopressin to control bleeding in postpartum hysterectomy due to abnormally invasive placenta.,"OBJECTIVE


To investigate the effect of subendometrial vasopressin injection in patients with abnormally invasive placenta (AIP), who underwent cesarean section and hysterectomy.
METHODS


This randomized double-blinded clinical trial was conducted on pregnant women diagnosed with AIP grade 4 and 5 by ultrasonography during cesarean section. Women were randomly divided into two equal groups including group 1 (vasopressin) and group 2 (control) who underwent 20 units of vasopressin and 20 cc normal saline injection, respectively. Vasopressin and placebo were injected subendometrially 1 cm medial to the uterine vessels into the lower uterine segment. The exclusion criteria include presence of myocardial infarction, cardiomyopathy, congestive heart failure, uncontrolled hypertension, chronic obstructive pulmonary disease, pelvic malignancy. The outcome of the study was total quantitative blood loss during the cesarean section. We estimated blood loss by measuring the blood volume in one of the suction bottles with addition for weight changes of mops, pads, and soaked linen savers.
RESULTS


Sixty patients were recruited into the study, 30 as the vasopressin group and 30 as the controls; with no excluded case. The amount of bleeding in the vasopressin group was significantly lower compared with that in the control group (P<0.001). In the vasopressin group, 83.4% of patients had bleeding of less than 1.5 L, while only 3.3% of the control women had bleeding of less than 1.5 L (relative risk=5). In addition, the number of injected packed cells was lower in the vasopressin group (P<0.001).
CONCLUSION


It was shown that vasopressin injection can help prevent excess hemorrhage and the subsequent risks of anemia or blood transfusions during abdominal hysterectomy in women with AIP.",2020,"In addition, the number of injected packed cells was lower in the vasopressin group (P<0.001).
","['postpartum hysterectomy due to abnormally invasive placenta', 'women with AIP', 'Sixty patients were recruited into the study, 30 as the vasopressin group and 30 as the controls; with no excluded case', 'pregnant women diagnosed with AIP grade 4 and 5 by ultrasonography during cesarean section', 'patients with abnormally invasive placenta (AIP), who underwent cesarean section and hysterectomy']","['Vasopressin and placebo', 'subendometrial vasopressin injection', 'vasopressin', 'subendometrial injection of vasopressin', 'vasopressin injection', 'group 1 (vasopressin) and group 2 (control) who underwent 20 units of vasopressin and 20\xa0cc normal saline injection']","['number of injected packed cells', 'amount of bleeding', 'total quantitative blood loss', 'blood loss', 'bleeding']","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4735297', 'cui_str': 'Vasopressin (USP) Injection'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}]",60.0,0.168748,"In addition, the number of injected packed cells was lower in the vasopressin group (P<0.001).
","[{'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ghotbizadeh Vhdani', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Nasiri Khormoji', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Eftekhar', 'Affiliation': 'Anesthesia & Pain Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Deldar Pasikhani', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Hantoshzade', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Ghamari', 'Affiliation': 'Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Panahi', 'Affiliation': 'Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13440']
2368,33210287,Clinically Important Differences for Mobility Measures Derived from the Testosterone Trials.,"BACKGROUND/OBJECTIVES


Accurate estimates of clinically important difference (CID) are required for interpreting the clinical importance of treatments to improve physical function, but CID estimates vary in different disease populations. We determined the CID for two common measures of walking ability in mobility-limited older men.
DESIGN


Longitudinal, multisite placebo-controlled trial.
SETTING/PARTICIPANTS


Men enrolled in the Testosterone Trials who had self-reported mobility limitation and gait speed less than 1.2 m/second (n = 429). Testosterone- and placebo-allocated participants were combined for this study.
RESULTS


Mean changes from baseline, adjusting for time-in-intervention and site, were 29.6, 13.2, 12.5, -2.4, and -32.6 m for 6MWD, and 15.4, 7.2, 2.1, -3.4, and -7.2 for PF10 in men who reported their mobility was ""very/much better,"" ""little better,"" ""no change,"" ""little worse,"" or ""much worse,"" respectively. CID estimates using regression, ROC, and eCDF varied from 5.0-29.6 m for 6MWD, and 5.0-15.2 points for PF10.
CONCLUSION


CID estimates vary by the population studied and by the method and precision of measurement. Increases of 16 to 30 m for 6MWD and 5 to 15 points for PF10 over 12 months appear to be clinically meaningful in mobility-limited, older hypogonadal men. These CID estimates may be useful in the design of efficacy trials of therapies to improve physical function.",2020,"CID estimates using regression, ROC, and eCDF varied from 5.0-29.6 m for 6MWD, and 5.0-15.2 points for PF10.
","['Men enrolled in the Testosterone Trials who had self-reported mobility limitation and gait speed less than 1.2 m/second (n = 429', 'mobility-limited older men', 'older hypogonadal men']",['Testosterone- and placebo'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],429.0,0.103764,"CID estimates using regression, ROC, and eCDF varied from 5.0-29.6 m for 6MWD, and 5.0-15.2 points for PF10.
","[{'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Farrar', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Section of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Department of Aging & Geriatric Research, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': 'Section of Geriatric Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16942']
2369,33210299,Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease.,"BACKGROUND


Fatigue is a burdensome symptom for patients with inflammatory bowel disease (IBD). Few pharmacological interventions have documented effect on fatigue in patients with IBD. A pilot study indicated a 20-day effect  with high-dose thiamine.
AIMS


To investigate the effect and safety of high-dose oral thiamine (600-1800 mg/d) based on gender and weight on chronic fatigue in patients with quiescent IBD.
METHODS


This was a randomised, double-blinded, placebo-controlled crossover trial. Patients had quiescent IBD, severe chronic fatigue and no other explanation for fatigue. Patients were allocated 1:1 to either 1) high-dose oral thiamine for 4 weeks, 4 weeks of washout, 4 weeks of oral placebo or 2) oral placebo for 4 weeks, 4 weeks of washout, 4 weeks of high-dose oral thiamine. Fatigue was measured using the Inflammatory Bowel Disease-Fatigue Questionnaire. The primary outcome was improvement (≥3 points) of fatigue after 4 weeks on thiamine.
RESULTS


Forty patients were enrolled between November 2018 and October 2019. Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo. Furthermore, 55% of group 1 and 75% of group 2 showed an improvement ≥ 3 points while on thiamine compared with 25% of group 1 and 35% of group 2 while on placebo. Only mild side effects were detected.
CONCLUSION


We showed a significant beneficial effect of high-dose oral thiamine on chronic fatigue in IBD. The treatment was well tolerated.
TRIAL REGISTRATION


NCT03634735.",2020,Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo.,"['patients with quiescent inflammatory bowel disease', 'patients with quiescent IBD', 'patients with inflammatory bowel disease (IBD', 'Forty patients were enrolled between November 2018 and October 2019', 'patients with IBD']","['placebo or 2) oral placebo', 'high-dose thiamine', 'thiamine', '1) high-dose oral thiamine', 'high-dose oral thiamine', 'placebo', 'thiamine versus placebo']","['quiescent IBD, severe chronic fatigue', 'fatigue', 'Inflammatory Bowel Disease-Fatigue Questionnaire', 'mild side effects', 'tolerated', 'Fatigue', 'improvement (≥3 points) of fatigue', 'chronic fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}]","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0518656', 'cui_str': 'Chronic fatigue'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",40.0,0.652538,Crossover analysis showed a mean reduction of 4.5 points (95% CI 2.6-6.2) in fatigue after thiamine compared with a mean increase of 0.75 point (95% CI -1.3-2.8; P = 0.0003) after placebo.,"[{'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Bager', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Christian Lodberg', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Charlotte Lock', 'Initials': 'CL', 'LastName': 'Rud', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Jens Frederik', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus N, Denmark.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16166']
2370,33210302,COVIDOSE: A phase 2 clinical trial of low-dose tocilizumab in the treatment of non-critical COVID-19 pneumonia.,"Interleukin-6 (IL-6)-mediated hyperinflammation may contribute to the mortality of coronavirus disease 2019 (COVID-19). The IL-6 receptor blocking monoclonal antibody tocilizumab has been repurposed for COVID-19, but prospective trials and dose-finding studies in COVID-19 have not yet fully reported. We conducted a single-arm phase 2 trial of low-dose tocilizumab in non-intubated hospitalized adult patients with COVID-19, radiographic pulmonary infiltrate, fever, and C-reactive protein (CRP) ≥ 40 mg/L. We hypothesized that doses significantly lower than the emerging standards of 400 mg or 8 mg/kg would resolve clinical and laboratory indicators of hyperinflammation. A dose range from 40 to 200 mg was evaluated, with allowance for one repeat dose at 24 to 48 hours. The primary objective was to assess the relationship of dose to fever resolution and CRP response. Thirty-two patients received low-dose tocilizumab, with the majority experiencing fever resolution (75%) and CRP decline consistent with IL-6 pathway abrogation (86%) in the 24-48 hours following drug administration. There was no evidence of a relationship between dose and fever resolution or CRP decline over the dose range of 40-200 mg. Within the 28-day follow-up, 5 (16%) patients died. For patients who recovered, median time to clinical recovery was 3 days (IQR, 2-5). Clinically presumed and/or cultured bacterial superinfections were reported in 5 (16%) patients. Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with COVID-19. Results of this trial provide rationale for a randomized, controlled trial of low-dose tocilizumab in COVID-19.",2020,Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with COVID-19.,"['non-critical COVID-19 pneumonia', 'hospitalized patients with COVID-19', 'non-intubated hospitalized adult patients with COVID-19, radiographic pulmonary infiltrate, fever, and C-reactive protein (CRP) ≥ 40 mg/L']","['low-dose tocilizumab', 'tocilizumab']","['relationship of dose to fever resolution and CRP response', 'CRP decline consistent with IL-6 pathway abrogation', 'fever resolution or CRP decline', 'median time to clinical recovery']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.304254,Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with COVID-19.,"[{'ForeName': 'Garth W', 'Initials': 'GW', 'LastName': 'Strohbehn', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Heiss', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sherin J', 'Initials': 'SJ', 'LastName': 'Rouhani', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Trujillo', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jovian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alec J', 'Initials': 'AJ', 'LastName': 'Kacew', 'Affiliation': 'Pritzker School of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Higgs', 'Affiliation': 'Committee on Immunology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Bloodworth', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Cabanov', 'Affiliation': 'Committee on Immunology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Adriana K', 'Initials': 'AK', 'LastName': 'Koziol', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'Department of Medicine, Section of Pulmonary and Critical Care Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Danahey', 'Affiliation': 'Center for Personalized Therapeutics, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Karrison', 'Affiliation': 'Department of Public Health Policy, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Cuoghi C', 'Initials': 'CC', 'LastName': 'Edens', 'Affiliation': 'Department of Medicine, Section of Rheumatology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Iazsmin Bauer', 'Initials': 'IB', 'LastName': 'Ventura', 'Affiliation': 'Department of Medicine, Section of Rheumatology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Natasha N', 'Initials': 'NN', 'LastName': 'Pettit', 'Affiliation': 'Department of Pharmacy, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Bhakti K', 'Initials': 'BK', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Section of Pulmonary and Critical Care Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pisano', 'Affiliation': 'Department of Medicine, Section of Infectious Diseases and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Strek', 'Affiliation': 'Department of Medicine, Section of Pulmonary and Critical Care Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Pankti D', 'Initials': 'PD', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Section of Rheumatology, The University of Chicago, Chicago, IL, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2117']
2371,33210309,"The Haemostasis Traffic Light, a user-centred coagulation management tool for acute bleeding situations: a simulation-based randomised dual-centre trial.","The Haemostasis Traffic Light is a cognitive aid with a user-centred design to enhance and simplify situation awareness and decision-making during peri-operative bleeding. Its structure helps to prioritise therapeutic interventions according to the pathophysiology and the severity of the bleeding. This investigator-initiated, randomised, prospective, international, dual-centre study aimed to validate the Haemostasis Traffic Light by adapting it to the local coagulation protocols of two university hospitals. Between 9 January and 12 May 2020, we recruited 84 participants at the University Hospital Zurich, Switzerland, and the Italian Hospital of Buenos Aires, Argentina. Each centre included 21 resident and 21 staff anaesthetists. Participants were randomly allocated to either the text-based algorithm or the Haemostasis Traffic Light. All participants managed six bleeding scenarios using the same algorithm. In simulated bleeding scenarios, the design of the Haemostasis Traffic Light algorithm enabled more correctly solved cases, OR (95%CI) 7.23 (3.82-13.68), p < 0.001, and faster therapeutic decisions, HR (95%CI) 1.97 (1.18-3.29, p = 0.010). In addition, the tool improved therapeutic confidence, OR (95%CI) 4.31 (1.67-11.11, p = 0.003), and reduced perceived work-load coefficient (95%CI) -6.1 (-10.98 to -1.22), p = 0.020). This study provides empirical evidence for the importance of user-centred design in the development of haemostatic management protocols.",2020,"In addition, the tool improved therapeutic confidence, OR (95%CI) 4.31 (1.67-11.11, p = 0.003), and reduced perceived work-load coefficient (95%CI) -6.1 (-10.98 to -1.22), p = 0.020).","['Each centre included 21 resident and 21 staff anaesthetists', 'Between 9 January and 12 May 2020, we recruited 84 participants at the University Hospital Zurich, Switzerland, and the Italian Hospital of Buenos Aires, Argentina', 'acute bleeding situations', 'two university hospitals']",['text-based algorithm or the Haemostasis Traffic Light'],"['therapeutic confidence, OR (95%CI']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0333276', 'cui_str': 'Acute hemorrhage'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",84.0,0.0500505,"In addition, the tool improved therapeutic confidence, OR (95%CI) 4.31 (1.67-11.11, p = 0.003), and reduced perceived work-load coefficient (95%CI) -6.1 (-10.98 to -1.22), p = 0.020).","[{'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Kataife', 'Affiliation': 'Department of Anaesthesiology, Hospital Italiano de Buenos Aires, Argentina.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Said', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Departments of Epidemiology and Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Roche', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rössler', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kaserer', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Switzerland.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Spahn', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Switzerland.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Mileo', 'Affiliation': 'Department of Anaesthesiology, Hospital Italiano de Buenos Aires, Argentina.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Tscholl', 'Affiliation': 'Institute of Anaesthesiology, University of Zurich and University Hospital Zurich, Switzerland.'}]",Anaesthesia,['10.1111/anae.15314']
2372,33210328,"The effect of delaying first bathing on skin barrier function in late preterm infants: A study protocol for multi-centre, single-blind RCT.","AIMS


The study aims to examine the effect of delaying first bathing on skin barrier function, body temperature, and neonatal comfort of late preterm infants.
DESIGN


This study is a multi-centre, single-blind, prospective randomized controlled trial.
METHODS


We attempt to report this randomized controlled trial to comply with the SPIRIT. The study population will consist of 80 late preterm infants born at three centres (hospitals) in Turkey. The study, between September 2020-September 2021 will be held in the Neonatal Intensive Care Unit. The participants will be randomly divided into two groups, each with different bathing times. The first group (N = 40) will be bathed between 24-48 hr after birth and the second group (N = 40) will be bathed between 48-72 hr after birth. Each group's intervention will be performed by a blinded researcher. The infants' transepidermal water loss, body temperature, and comfort level will be measured before the bath and again at three times after the bath. The measurements will be taken by a blinded researcher and blinded nurse.
DISCUSSION


The benefits of infant bathing are known. However, the effect of delaying first bathing of late preterm infants on skin barrier function is unknown. At the same time, the effect of delaying bathing on maintaining body temperature and neonatal comfort is unknown.
IMPACT


This study is expected to provide a piece of credible evidence of the delay of first bathing and benefit of neonatal care in this population. It is thought that postponing bathing time of late preterm infants to 48-72 hr after birth will lead to a protective effect on skin barrier and temperature. It will be performed in clinical practice if it can effectively improve transepidermal water loss and heat loss.
TRIAL REGISTRATION


It was registered at ClinicalTrials.gov in January 2020 (NCT04231799).",2020,"The infants' transepidermal water loss, body temperature, and comfort level will be measured before the bath and again at three times after the bath.","['late preterm infants', '80 late preterm infants born at three centres (hospitals) in Turkey']",[],"['skin barrier function', 'transepidermal water loss and heat loss', 'transepidermal water loss, body temperature, and comfort level', 'skin barrier function, body temperature, and neonatal comfort']","[{'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0018840', 'cui_str': 'Heat Loss'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]",40.0,0.169328,"The infants' transepidermal water loss, body temperature, and comfort level will be measured before the bath and again at three times after the bath.","[{'ForeName': 'Halil İbrahim', 'Initials': 'Hİ', 'LastName': 'Taşdemir', 'Affiliation': 'Child Health Nursing Department, Nursing Faculty, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Efe', 'Affiliation': 'Child Health Nursing Department, Nursing Faculty, Akdeniz University, Antalya, Turkey.'}]",Journal of advanced nursing,['10.1111/jan.14657']
2373,33210335,A randomised clinical trial of multifocal contact lenses and contact lens discomfort.,"PURPOSE


To determine how multifocal contact lenses affect contact lens discomfort.
METHODS


This randomised, participant-masked, crossover clinical trial fitted 84 uncomfortable soft contact lens wearers (30-40 years old) with single vision and multifocal contact lenses. Contact lens discomfort was assessed using the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8).
RESULTS


There was no difference between multifocal and single vision survey scores (p = 0.08). There was an interaction between lens type and age group (p = 0.05). CLDEQ-8 scores with the single vision lens were less symptomatic than multifocal scores in participants <35 years old (p = 0.01). Single vision and multifocal scores for the older age group were not different. Subjectively, those in the <35 year-old age group preferred the single vision lens for intermediate (p = 0.02), distance (p = 0.003), and overall vision (p = 0.002). In the ≥35 year-old age group, no lens was significantly preferred for vision.
CONCLUSIONS


Participants in the younger age group had more favourable wearing experiences with the single vision lens compared to the multifocal lens. The older age group, however, had similar wearing experiences with both lens types. While younger contact lens wearers may prefer the wearing experience with single vision lenses, some uncomfortable contact lens wearers approaching 40 years old may benefit from wearing a multifocal contact lens sooner in life than is typically practised.",2020,CLDEQ-8 scores with the single vision lens were less symptomatic than multifocal scores in participants <35 years old (p = 0.01).,['84 uncomfortable soft contact lens wearers (30-40\xa0years old) with single vision and multifocal contact lenses'],['multifocal contact lenses and contact lens discomfort'],"['Single vision and multifocal scores', 'overall vision', 'multifocal and single vision survey scores', 'single vision lens', 'Contact lens discomfort', 'CLDEQ-8 scores']","[{'cui': 'C0009838', 'cui_str': 'Hydrophilic contact lens'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",84.0,0.035457,CLDEQ-8 scores with the single vision lens were less symptomatic than multifocal scores in participants <35 years old (p = 0.01).,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Rueff', 'Affiliation': 'Southern California College of Optometry, Marshall B. Ketchum University, Fullerton, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jones-Jordan', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Bailey', 'Affiliation': 'The Ohio State University College of Optometry, Columbus, USA.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12761']
2374,33210345,Patient Navigation to Improve Early Access to Supportive Care for Patients with Advanced Cancer in Resource-limited Settings: a Randomized Controlled Trial.,"BACKGROUND


The early integration of supportive care in oncology improves patient-centered outcomes. However, data is lacking regarding how to achieve this in resource-limited settings. We studied whether patient navigation increased access to multidisciplinary supportive care among Mexican patients with advanced cancer.
MATERIALS AND METHODS


This randomized controlled trial was conducted between 08/17 and 04/2018 at a public hospital in Mexico City. Patients aged ≥18 with metastatic tumors ≤six weeks from diagnosis were randomized (1:1) to a patient navigation intervention or usual care. Patients randomized to patient navigation received personalized supportive care from a navigator and a multidisciplinary team. Patients randomized to usual care obtained supportive care referrals from treating oncologists. The primary outcome was the implementation of supportive care interventions at 12 weeks. Secondary outcomes included advance directive completion, supportive care needs, and quality of life.
RESULTS


134 patients were randomized: 67 to patient navigation and 67 to usual care. Supportive care interventions were provided to 74% of patients in the patient navigation arm vs. 24% in usual care (difference 0.50, 95% CI 0.34-0.62; p<0.0001). In the patient navigation arm, 48% of eligible patients completed advance directives, compared to 0% in usual care (p<0.0001). At 12 weeks, patients randomized to patient navigation had less moderate/severe pain (10 vs. 33%; difference 0.23, 95% CI 0.07-0.38; p = 0.006), without differences in quality of life between arms.
CONCLUSIONS AND RELEVANCE


Patient navigation improves access to early supportive care, advance care planning, and pain for patients with advanced cancer in resource-limited settings.
IMPLICATIONS FOR PRACTICE


The early implementation of supportive care in oncology is recommended by international guidelines, but this might be difficult to achieve in resource limited settings. This randomized clinical trial including 134 Mexican patients with advanced cancer, demonstrates that a multidisciplinary patient navigation intervention can improve the early access to supportive and palliative care interventions, increase advance care planning, and reduce symptoms compared with usual oncologist-guided care alone. These results demonstrate that patient navigation represents a potentially useful solution to achieve the adequate implementation of supportive and palliative care in resource-limited settings globally.",2020,"In the patient navigation arm, 48% of eligible patients completed advance directives, compared to 0% in usual care (p<0.0001).","['Patients aged ≥18 with metastatic tumors ≤six weeks from diagnosis', '134 patients were randomized: 67 to patient navigation and 67 to usual care', '08/17 and 04/2018 at a public hospital in Mexico City', 'patients with advanced cancer in resource-limited settings', 'Mexican patients with advanced cancer', 'Patients with Advanced Cancer in Resource-limited Settings', '134 Mexican patients with advanced cancer']","['usual care obtained supportive care referrals from treating oncologists', 'patient navigation received personalized supportive care from a navigator and a multidisciplinary team', 'usual oncologist-guided care alone', 'usual care ', 'patient navigation intervention or usual care', 'Patient Navigation to Improve Early Access to Supportive Care', 'patient navigation increased access to multidisciplinary supportive care', 'multidisciplinary patient navigation intervention']","['moderate/severe pain', 'implementation of supportive care interventions', 'advance directives', 'advance directive completion, supportive care needs, and quality of life', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",134.0,0.236078,"In the patient navigation arm, 48% of eligible patients completed advance directives, compared to 0% in usual care (p<0.0001).","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Soto-Perez-de-Celis', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Yanin', 'Initials': 'Y', 'LastName': 'Chavarri-Guerra', 'Affiliation': 'Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Wendy Alicia', 'Initials': 'WA', 'LastName': 'Ramos-Lopez', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Alcalde-Castro', 'Affiliation': 'Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Covarrubias-Gomez', 'Affiliation': 'Department of Pain and Palliative Care Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'África', 'Initials': 'Á', 'LastName': 'Navarro-Lara', 'Affiliation': 'Physical Therapy Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Quiroz-Friedman', 'Affiliation': 'Department of Neurology and Psychiatry, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Sánchez-Román', 'Affiliation': 'Department of Neurology and Psychiatry, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Alcocer-Castillejos', 'Affiliation': 'Department of Neurology and Psychiatry, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Aguilar-Velazco', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bukowski', 'Affiliation': 'Global Cancer Institute, P.O. Box 8736., Boston, MA, 02114-9998, USA.'}, {'ForeName': 'Juan Alberto', 'Initials': 'JA', 'LastName': 'Chávarri-Maldonado', 'Affiliation': 'Universidad Autónoma de Ciudad Juárez. Manuel Díaz H. No. 518-B Zona Pronaf Condominio, 32315, Cd Juárez, Mexico.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Contreras-Garduño', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Krush', 'Affiliation': 'Global Cancer Institute, P.O. Box 8736., Boston, MA, 02114-9998, USA.'}, {'ForeName': 'Itoro', 'Initials': 'I', 'LastName': 'Inoyo', 'Affiliation': 'Global Cancer Institute, P.O. Box 8736., Boston, MA, 02114-9998, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Medina-Campos', 'Affiliation': 'Physical Therapy Service, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Moreno-García', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Perez-Montessoro', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Bourlon', 'Affiliation': 'Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de la Peña-Lopez', 'Affiliation': 'Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'de la Mora-Molina', 'Affiliation': 'Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Eucario', 'Initials': 'E', 'LastName': 'León-Rodriguez', 'Affiliation': 'Department of Hematology and Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Vasco de Quiroga 15, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Mohar', 'Affiliation': 'Unidad de Investigación Biomédica, Instituto Nacional de Cancerología UNAM. Avenida San Fernando 22, Sección XVI, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Goss', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street., Boston, MA, USA.'}]",The oncologist,['10.1002/onco.13599']
2375,33210468,Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine.,"Neisseria meningitidis is a major cause of meningitis and septicaemia. A MenB vaccine (4CMenB) was licensed by the European Medicines Agency in January 2013. Here we describe the blood transcriptome and proteome following infant immunisations with or without concomitant 4CMenB, to gain insight into the molecular mechanisms underlying post-vaccination reactogenicity and immunogenicity. Infants were randomised to receive control immunisations (PCV13 and DTaP-IPV-Hib) with or without 4CMenB at 2 and 4 months of age. Blood gene expression and plasma proteins were measured prior to, then 4 h, 24 h, 3 days or 7 days post-vaccination. 4CMenB vaccination was associated with increased expression of ENTPD7 and increased concentrations of 4 plasma proteins: CRP, G-CSF, IL-1RA and IL-6. Post-vaccination fever was associated with increased expression of SELL, involved in neutrophil recruitment. A murine model dissecting the vaccine components found the concomitant regimen to be associated with increased gene perturbation compared with 4CMenB vaccine alone with enhancement of pathways such as interleukin-3, -5 and GM-CSF signalling. Finally, we present transcriptomic profiles predictive of immunological and febrile responses following 4CMenB vaccine.",2020,"4CMenB vaccination was associated with increased expression of ENTPD7 and increased concentrations of 4 plasma proteins: CRP, G-CSF, IL-1RA and IL-6. Post-vaccination fever was associated with increased expression of SELL, involved in neutrophil recruitment.",[],"['MenB vaccine (4CMenB', '4CMenB vaccine', 'control immunisations (PCV13 and DTaP-IPV-Hib) with or without 4CMenB']","['expression of ENTPD7 and increased concentrations of 4 plasma proteins: CRP, G-CSF, IL-1RA and IL-6. Post-vaccination fever', 'Blood gene expression and plasma proteins']",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3490189', 'cui_str': '4CMenB vaccine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C2716396', 'cui_str': 'diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C2349672', 'cui_str': 'Post vaccination fever'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",,0.0581828,"4CMenB vaccination was associated with increased expression of ENTPD7 and increased concentrations of 4 plasma proteins: CRP, G-CSF, IL-1RA and IL-6. Post-vaccination fever was associated with increased expression of SELL, involved in neutrophil recruitment.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta Valente', 'Initials': 'MV', 'LastName': 'Pinto', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Sheerin', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Tomic', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Drury', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Channon-Wells', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Health Care, Clinical Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kerridge', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Plested', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Hughes', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Stockdale', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sadarangani', 'Affiliation': 'Department of Pediatrics, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Rollier', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}]",Molecular systems biology,['10.15252/msb.20209888']
2376,33210488,[Comparison of three medical goggle sterilizing approaches].,"OBJECTIVE


To compare three sterilizing methods for reusable medical goggles.
METHODS


A total of 180 medical goggles of the same brand and same model were randomly divided into three groups. In group A the goggles were first soaked with 2000 mg/L chlorine-containing disinfectant and then cleaned manually; goggles in other two groups were sterilized using pre-programmed automatic spray cleaning and disinfection machine, the disinfection program was set to 90 ℃ for 5 min in group B and 70 ℃ for 30 min in group C. The quality of the sterilization was monitored by visual inspection with luminous magnifying glass and residual protein detection assay. User satisfaction on cleanliness of medical goggles, clarity of mirror surface and suitability of elastic bands was investigated with questionnaire survey.
RESULTS


The qualification rates verified by visual inspection were 82.4%, 84.6%and 98.3%in group A, B and C, respectively, the qualification rate in group C was significantly higher than those in group B and group C (all  P <0.05). The qualification rates verified by residual protein detection assay were 96.7%, 100.0%and 100.0%in group A, B and C, respectively ( P >0.05). A total of 54 questionnaires were submitted for the survey. The satisfaction rates were 100.0%, 90.7%and 94.4% for cleanliness of medical goggles, clarity of mirror surface and suitability of elastic bands, respectively.
CONCLUSIONS


Machinery sterilization set 70 ℃ for 30 min has better cleaning and sterilizing effects for reusable medical goggles.",2020,"CONCLUSIONS


Machinery sterilization set 70 ℃ for 30 min has better cleaning and sterilizing effects for reusable medical goggles.",['A total of 180 medical goggles of the same brand and same model'],[],"['qualification rate', 'quality of the sterilization', 'User satisfaction on cleanliness of medical goggles, clarity of mirror surface and suitability of elastic bands', 'satisfaction rates', 'qualification rates verified by visual inspection']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0522513', 'cui_str': 'With cleanliness'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018020', 'cui_str': 'Goggles'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}]",54.0,0.0145263,"CONCLUSIONS


Machinery sterilization set 70 ℃ for 30 min has better cleaning and sterilizing effects for reusable medical goggles.","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Central Sterile Supply Department, the First Affiliated Hospital, Zhejiang University School of Medical, Hangzhou 310003, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Central Sterile Supply Department, the First Affiliated Hospital, Zhejiang University School of Medical, Hangzhou 310003, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Central Sterile Supply Department, the First Affiliated Hospital, Zhejiang University School of Medical, Hangzhou 310003, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Pu', 'Affiliation': 'Central Sterile Supply Department, the First Affiliated Hospital, Zhejiang University School of Medical, Hangzhou 310003, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Lyu', 'Affiliation': 'Central Sterile Supply Department, the First Affiliated Hospital, Zhejiang University School of Medical, Hangzhou 310003, China.'}]",Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences,['10.3785/j.issn.1008-9292.2020.10.10']
2377,33210508,[Surgical treatment of low anterior resection syndrome].,"OBJECTIVE


To compare functional outcomes of various rectal reconstruction after total mesorectal excision.
MATERIAL AND METHODS


A prospective randomized trial included 90 patients with mid-to-low rectal carcinoma who underwent total mesorectal excision.
RESULTS


There were 22 patients after J-pouch surgery, 30 patients with side-to-end anastomoses and 38 patients with end-to-end anastomoses. Eight patients (26.6%) required conversion of J-P to E-E (7 patients) and S-E (1) anastomosis for technical reasons. Postoperative morbidity was similar (13.6, 16.7 and 34.2% in J-P, S-E and E-E groups, respectively,  p =0.705). Sensory threshold, earliest and constant defecation urge and maximal tolerable volume were higher for J-P surgery within 3-6-12 months after surgery. Stool frequency was significantly lower after J-P surgery compared to S-E and E-E anastomoses within 3-6-12 months. Wexner scores were 3, 5, 6 after 6 months ( p <0.05) and 0, 1, 1 after 12 months for J-P, S-E and E-E, respectively ( p >0.05). Evacuation dysfunction was observed in 59.1% with J-P, 33.3% with S-E and 21.1% with E-E anastomoses in 6 months after stoma closure.
CONCLUSION


J-pouch reconstruction demonstrates higher neorectal volume that ensures reduced stool frequency up to 12 months after stoma closure. However, technical challenges of J-pouch surgery and evacuation dysfunction restrain application of this procedure in clinical practice.",2020,"Sensory threshold, earliest and constant defecation urge and maximal tolerable volume were higher for J-P surgery within 3-6-12 months after surgery.","['90 patients with mid-to-low rectal carcinoma who underwent total mesorectal excision', 'low anterior resection syndrome', '22 patients after J-pouch surgery, 30 patients with side-to-end anastomoses and 38 patients with end-to-end anastomoses']",['various rectal reconstruction after total mesorectal excision'],"['Stool frequency', 'Sensory threshold, earliest and constant defecation urge and maximal tolerable volume', 'Wexner scores', 'stool frequency', 'Evacuation dysfunction', 'Postoperative morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}, {'cui': 'C0086492', 'cui_str': 'J pouch'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0392773', 'cui_str': 'Anastomosis, side to end'}, {'cui': 'C0332855', 'cui_str': 'Anastomosis, end to end'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0036677', 'cui_str': 'Sensory threshold'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",90.0,0.0249293,"Sensory threshold, earliest and constant defecation urge and maximal tolerable volume were higher for J-P surgery within 3-6-12 months after surgery.","[{'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Rasulov', 'Affiliation': 'Lopatkin Research Institute of Urology and Interventional Radiology, Moscow, Russia.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Baichorov', 'Affiliation': 'Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Merzlykova', 'Affiliation': 'Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Ovchinnikova', 'Affiliation': 'Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Semyanikhina', 'Affiliation': 'Blokhin Russian Cancer Research Center, Moscow, Russia.'}]",Khirurgiia,['10.17116/hirurgia202011153']
2378,33210650,Comparison of Proton Pump Inhibitor and Triple Therapy Regimen for Laryngospharyngeal Reflux Disease.,"BACKGROUND


Laryngopharyngeal reflux is retrograde flow of contents of the stomach to the larynx and the pharynx. The study aims to compare two regimens (proton pump inhibitor monotherapy versus triple therapy) on the outcome of Helicobactor pylori positive laryngopharyngeal reflux disease.
METHODS


The presence of laryngopharyngeal reflux was determined by reflux symptom index and reflux finding score. The presence of Helicobactor pylori in the tissue was confirmed by rapid urease test. All urease test negative laryngopharyngeal reflux patients were given a course of proton pump inhibitors and results were evaluated. All urease test positive patients were divided into two groups. One group was given a course of proton pump inhibitors and another group was given a course of triple therapy and the results were compared.
RESULTS


A total number of 704 laryngopharyngeal reflux patients were screened for urease test. Among them 138 patients (19.6 %) were urease test negative and were given proton pump inhibitor therapy. Improvement in both reflux finding score (average score 11.75) and reflux symptom index (average score 5.25) score was observed after 3 months with p-value<0.05. In urease test positive patients, improvement in scores was observed in both proton pump inhibitors and triple therapy group, however marked improvement in the clinical features was observed in triple therapy group with p-value<0.05.
CONCLUSIONS


The study reveals association between laryngopharyngeal reflux and Helicobactor pylori. Proton pump inhibitor therapy is sufficient if no Helicobactor pylori is detected, however incase of presence of Helicobactor pylori, triple therapy gives better results.",2020,Improvement in both reflux finding score (average score 11.75) and reflux symptom index (average score 5.25) score was observed after 3 months with p-value<0.05.,"['704 laryngopharyngeal reflux patients', 'Laryngospharyngeal Reflux Disease']","['Proton Pump Inhibitor and Triple Therapy Regimen', 'proton pump inhibitors', 'proton pump inhibitor therapy', 'Proton pump inhibitor therapy', 'proton pump inhibitor monotherapy versus triple therapy']","['clinical features', 'laryngopharyngeal reflux and Helicobactor pylori', 'Helicobactor pylori positive laryngopharyngeal reflux disease', 'reflux symptom index', 'laryngopharyngeal reflux', 'improvement in scores', 'reflux symptom index and reflux finding score']","[{'cui': 'C1168250', 'cui_str': 'Laryngopharyngeal reflux'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1168250', 'cui_str': 'Laryngopharyngeal reflux'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",,0.0310794,Improvement in both reflux finding score (average score 11.75) and reflux symptom index (average score 5.25) score was observed after 3 months with p-value<0.05.,"[{'ForeName': 'Apar', 'Initials': 'A', 'LastName': 'Pokharel', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, College of Medical Sciences, Chitwan, Nepal.'}, {'ForeName': 'Jaya Prakash', 'Initials': 'JP', 'LastName': 'Mayya', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, College of Medical Sciences, Chitwan, Nepal.'}, {'ForeName': 'Hari Prasad', 'Initials': 'HP', 'LastName': 'Upadhyay', 'Affiliation': 'Department of Community Medicine and Biostatistics, College of Medical sciences, Chitwan, Nepal.'}]",Journal of Nepal Health Research Council,['10.33314/jnhrc.v18i3.2493']
2379,33210731,Salvage systemic therapy for advanced gastric and oesophago-gastric junction adenocarcinoma.,"BACKGROUND


Salvage systemic therapy has become the new standard of care in patients with advanced gastric and oesophago-gastric junction (OGJ) adenocarcinoma, following disease progression on first-line fluoropyrimidine and platinum-containing chemotherapy. Pharmacological agents proven to be effective in this setting include both chemotherapy and biological therapy, however, the consensus on the best salvage systemic therapy has not been reached.
OBJECTIVES


To assess the effects of systemic chemotherapy and biological therapy, either alone or in combination, on overall survival (OS) and progression-free survival (PFS) in patients with advanced gastric and OGJ adenocarcinoma, whose disease has progressed on, or relapsed after first-line fluoropyrimidine and platinum-containing chemotherapy. Adverse events (AEs), tumour response rate (TRR) and quality of life (QoL) associated with systemic chemotherapy and/or biological therapy were additionally assessed.
SEARCH METHODS


We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, trial registries and proceedings of the major oncology conferences up to October 2020. We additionally handsearched the reference lists of studies. No language restriction was applied.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) comparing salvage systemic therapy (chemotherapy and/or biological therapy) and either another type of salvage systemic therapy, placebo, best supportive care (BSC) or no treatment in patients with gastric and OGJ adenocarcinoma refractory to first-line fluoropyrimidine and platinum-containing chemotherapy.
DATA COLLECTION AND ANALYSIS


Two review authors independently performed selection of eligible studies and the primary author extracted study characteristics and outcome data from included studies. We assessed the quality and risk of bias of eligible studies according to the Cochrane Handbook for Systematic Reviews of Interventions. We expressed pooled estimates of effect using hazard ratio (HR) calculated using an inverse variance random-effects model for time-to-event data, and risk ratio (RR) calculated using Mantel-Haenszel random-effects model for binary data. The certainty of evidence was graded using GRADEpro.
MAIN RESULTS


We identified 17 RCTs with 5110 participants for inclusion in this review. Tweenty-nine studies are ongoing and twenty studies are awaiting classification. No studies examined the following comparisons: chemotherapy combined with biological therapy versus placebo, BSC or no treatment, chemotherapy combined with biological therapy versus biological therapy, biological therapy versus biological therapy and chemotherapy combined with biological therapy versus chemotherapy combined with biological therapy. Chemotherapy versus placebo, best supportive care or no treatment Chemotherapy probably improves OS (HR = 0.66, 95% CI 0.52 to 0.83, moderate-certainty evidence) based on two studies involving 547 participants and improves PFS (HR = 0.57, 95% CI 0.47 to 0.69, high-certainty evidence) based on one study involving 507 participants over placebo and BSC. Chemotherapy probably increases serious AEs (SAEs) (RR = 1.38, 95% CI 1.20 to 1.59, moderate-certainty evidence) based on one study involving 503 participants. Biological therapy versus placebo, best supportive care or no treatment Biological therapy improves OS (HR = 0.55, 95% CI 0.41 to 0.73, high-certainty evidence) and probably improves PFS (HR = 0.33, 95% CI 0.19 to 0.57, moderate-certainty evidence) over placebo based on three studies involving 781 participants. There is currently insufficient evidence for increased SAEs from biological therapy (RR = 1.14, 95% CI 0.95 to 1.37, low-certainty evidence) based on two studies involving 638 participants. Chemotherapy versus biological therapy This comparison only considered immunotherapy. There is probably no evidence of a difference for OS (HR = 0.82, 95% CI 0.66 to 1.02, moderate-certainty evidence) between chemotherapy and immunotherapy, and immunotherapy probably reduces PFS (HR = 1.27, 95% CI 1.03 to 1.57, moderate-certainty evidence) based on one study involving 395 participants. SAEs may be less frequent with immunotherapy compared to chemotherapy (RR = 0.41, 95% CI 0.30 to 0.57, low-certainty evidence). Chemotherapy combined with biological therapy versus chemotherapy Addition of biological therapy to chemotherapy probably does not improve OS (HR = 0.93, 95% CI 0.83 to 1.04, moderate-certainty evidence) and we are uncertain whether it improves PFS (HR = 0.87, 95% CI 0.74 to 1.02, very low-certainty evidence) based on seven studies involving 2743 participants. We are similarly uncertain whether combined chemotherapy and biological therapy increases SAEs (RR = 1.17, 95% CI 0.95 to 1.44, very low-certainty evidence) based on four studies involving 1618 participants. Chemotherapy versus chemotherapy There is no evidence of a difference for OS and PFS between irinotecan and paclitaxel (HR = 1.13, 95% CI 0.86 to 1.48, low-certainty evidence for OS; HR = 1.14, 95% CI 0.88 to 1.48, low-certainty evidence for PFS) based on one study involving 219 participants. Similarly, there is no evidence to indicate improved OS and PFS from addition of another chemotherapy to docetaxel (HR = 1.05, 95% CI 0.72 to 1.54, low-certainty evidence for OS; HR = 0.75, 95% CI 0.52 to 1.09, low-certainty evidence for PFS) based on two studies involving 121 participants. Grade ≥ 3 neutropenia occurred commonly with both mono- and poly-chemotherapy except for docetaxel-S1 and EOX chemotherapy.
AUTHORS' CONCLUSIONS


Survival outcome of patients with advanced gastric and OGJ adenocarcinoma whose disease progressed on first-line fluoropyrimidine and platinum-containing chemotherapy can be improved by chemotherapy and biological therapy. Biological therapy, in particular, achieves this without clear increase in SAEs or QoL impairment. Whether biological therapy is preferred over chemotherapy is still unclear and there is no evidence of a difference for OS outcome, although immunotherapy may be associated with less SAEs. Addition of biological therapy to chemotherapy and poly-chemotherapy are associated with frequent treatment-related toxicity without clear survival benefit.",2020,"Biological therapy versus placebo, best supportive care or no treatment Biological therapy improves OS (HR = 0.55, 95% CI 0.41 to 0.73, high-certainty evidence) and probably improves PFS (HR = 0.33, 95% CI 0.19 to 0.57, moderate-certainty evidence) over placebo based on three studies involving 781 participants.","['patients with advanced gastric and OGJ adenocarcinoma whose disease progressed on first-line', 'advanced gastric and oesophago-gastric junction adenocarcinoma', 'patients with gastric and OGJ adenocarcinoma refractory to first-line', '5110 participants for inclusion in this review', 'patients with advanced gastric and OGJ adenocarcinoma, whose disease has progressed on, or relapsed after first-line', 'patients with advanced gastric and oesophago-gastric junction (OGJ) adenocarcinoma, following disease progression on first-line']","['Chemotherapy versus placebo', 'salvage systemic therapy, placebo, best supportive care (BSC', 'Chemotherapy versus biological therapy', 'chemotherapy combined with biological therapy versus placebo, BSC or no treatment, chemotherapy combined with biological therapy versus biological therapy, biological therapy versus biological therapy and chemotherapy combined with biological therapy versus chemotherapy combined with biological therapy', 'Chemotherapy combined with biological therapy', 'docetaxel-S1 and EOX chemotherapy', 'biological therapy to chemotherapy and poly-chemotherapy', 'irinotecan and paclitaxel', 'salvage systemic therapy (chemotherapy and/or biological therapy', 'placebo', 'Salvage systemic therapy', 'Chemotherapy', 'Chemotherapy versus chemotherapy', 'fluoropyrimidine and platinum-containing chemotherapy', 'systemic chemotherapy and biological therapy']","['SAEs or QoL impairment', 'SAEs', 'overall survival (OS) and progression-free survival (PFS', 'OS and PFS', '3 neutropenia', 'Adverse events (AEs), tumour response rate (TRR) and quality of life (QoL', 'hazard ratio (HR', 'Grade ≥', 'PFS', 'time-to-event data, and risk ratio (RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",507.0,0.295808,"Biological therapy versus placebo, best supportive care or no treatment Biological therapy improves OS (HR = 0.55, 95% CI 0.41 to 0.73, high-certainty evidence) and probably improves PFS (HR = 0.33, 95% CI 0.19 to 0.57, moderate-certainty evidence) over placebo based on three studies involving 781 participants.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Medical Oncology, The Queen Elizabeth Hospital and University of Adelaide, Woodville, Adelaide, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Moldovan', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Chang Lee', 'Affiliation': 'Department of Medical Oncology, Adelaide Cancer Centre, Windsor Gardens, Australia.'}, {'ForeName': 'Amy Hc', 'Initials': 'AH', 'LastName': 'Hsieh', 'Affiliation': 'Medical Oncology, The Queen Elizabeth Hospital and University of Adelaide, Woodville, Adelaide, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Townsend', 'Affiliation': 'Medical Oncology, The Queen Elizabeth Hospital and University of Adelaide, Woodville, Adelaide, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Medical Oncology, The Queen Elizabeth Hospital and University of Adelaide, Woodville, Adelaide, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012078.pub2']
2380,33210751,Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus.,"BACKGROUND


The term prediabetes is used to describe a population with an elevated risk of developing type 2 diabetes mellitus (T2DM). With projections of an increase in the incidence of T2DM, prevention or delay of the disease and its complications is paramount. It is currently unknown whether pioglitazone is beneficial in the treatment of people with increased risk of developing T2DM.
OBJECTIVES


To assess the effects of pioglitazone for prevention or delay of T2DM and its associated complications in people at risk of developing T2DM.
SEARCH METHODS


We searched CENTRAL, MEDLINE, Chinese databases, ICTRP Search Portal and ClinicalTrials.gov. We did not apply any language restrictions. Further, we investigated the reference lists of all included studies and reviews. We tried to contact all study authors. The date of the last search of databases was November 2019 (March 2020 for Chinese databases).
SELECTION CRITERIA


We included randomised controlled trials (RCTs) with a minimum duration of 24 weeks, and participants diagnosed with intermediate hyperglycaemia with no concomitant diseases, comparing pioglitazone as monotherapy or part of dual therapy with other glucose-lowering drugs, behaviour-changing interventions, placebo or no intervention.
DATA COLLECTION AND ANALYSIS


Two review authors independently screened abstracts, read full-text articles and records, assessed risk of bias and extracted data. We performed meta-analyses with a random-effects model and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals (CIs) for effect estimates. We evaluated the certainty of the evidence with the GRADE.
MAIN RESULTS


We included 27 studies with a total of 4186 randomised participants. The size of individual studies ranged between 43 and 605 participants and the duration varied between 6 and 36 months. We judged none of the included studies as having low risk of bias across all 'Risk of bias' domains. Most studies identified people at increased risk of T2DM by impaired fasting glucose or impaired glucose tolerance (IGT), or both. Our main outcome measures were all-cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, nonfatal myocardial infarction or stroke (NMI/S), health-related quality of life (QoL) and socioeconomic effects. The following comparisons mostly reported only a fraction of our main outcome set. Three studies compared pioglitazone with metformin. They did not report all-cause and cardiovascular mortality, NMI/S, QoL or socioeconomic effects. Incidence of T2DM was 9/168 participants in the pioglitazone groups versus 9/163 participants in the metformin groups (RR 0.98, 95% CI 0.40 to 2.38; P = 0.96; 3 studies, 331 participants; low-certainty evidence). No SAEs were reported in two studies (201 participants; low-certainty evidence). One study compared pioglitazone with acarbose. Incidence of T2DM was 1/50 participants in the pioglitazone group versus 2/46 participants in the acarbose group (very low-certainty evidence). No participant experienced a SAE (very low-certainty evidence).One study compared pioglitazone with repaglinide. Incidence of T2DM was 2/48 participants in the pioglitazone group versus 1/48 participants in the repaglinide group (low-certainty evidence). No participant experienced a SAE (low-certainty evidence). One study compared pioglitazone with a personalised diet and exercise consultation. All-cause and cardiovascular mortality, NMI/S, QoL or socioeconomic effects were not reported. Incidence of T2DM was 2/48 participants in the pioglitazone group versus 5/48 participants in the diet and exercise consultation group (low-certainty evidence). No participant experienced a SAE (low-certainty evidence). Six studies compared pioglitazone with placebo. No study reported on QoL or socioeconomic effects. All-cause mortality was 5/577 participants the in the pioglitazone groups versus 2/579 participants in the placebo groups (Peto odds ratio 2.38, 95% CI 0.54 to 10.50; P = 0.25; 4 studies, 1156 participants; very low-certainty evidence). Incidence of T2DM was 80/700 participants in the pioglitazone groups versus 131/695 participants in the placebo groups (RR 0.40, 95% CI 0.17 to 0.95; P = 0.04; 6 studies, 1395 participants; low-certainty evidence). There were 3/93 participants with SAEs in the pioglitazone groups versus 1/94 participants in the placebo groups (RR 3.00, 95% CI 0.32 to 28.22; P = 0.34; 2 studies, 187 participants; very low-certainty evidence). However, the largest study for this comparison did not distinguish between serious and non-serious adverse events. This study reported that 121/303 (39.9%) participants in the pioglitazone group versus 151/299 (50.5%) participants in the placebo group experienced an adverse event (P = 0.03). One study observed cardiovascular mortality in 2/181 participants in the pioglitazone group versus 0/186 participants in the placebo group (RR 5.14, 95% CI 0.25 to 106.28; P = 0.29; very low-certainty evidence). One study observed NMI in 2/303 participants in the pioglitazone group versus 1/299 participants in the placebo group (RR 1.97: 95% CI 0.18 to 21.65; P = 0.58; very low-certainty evidence). Twenty-one studies compared pioglitazone with no intervention. No study reported on cardiovascular mortality, NMI/S, QoL or socioeconomic effects. All-cause mortality was 11/441 participants in the pioglitazone groups versus 12/425 participants in the no-intervention groups (RR 0.85, 95% CI 0.38 to 1.91; P = 0.70; 3 studies, 866 participants; very low-certainty evidence). Incidence of T2DM was 60/1034 participants in the pioglitazone groups versus 197/1019 participants in the no-intervention groups (RR 0.31, 95% CI 0.23 to 0.40; P < 0.001; 16 studies, 2053 participants; moderate-certainty evidence). Studies reported SAEs in 16/610 participants in the pioglitazone groups versus 21/601 participants in the no-intervention groups (RR 0.71, 95% CI 0.38 to 1.32; P = 0.28; 7 studies, 1211 participants; low-certainty evidence). We identified two ongoing studies, comparing pioglitazone with placebo and with other glucose-lowering drugs. These studies, with 2694 participants. may contribute evidence to future updates of this review.
AUTHORS' CONCLUSIONS


Pioglitazone reduced or delayed the development of T2DM in people at increased risk of T2DM compared with placebo (low-certainty evidence) and compared with no intervention (moderate-certainty evidence). It is unclear whether the effect of pioglitazone is sustained once discontinued. Pioglitazone compared with metformin neither showed advantage nor disadvantage regarding the development of T2DM in people at increased risk (low-certainty evidence). The data and reporting of all-cause mortality, SAEs, micro- and macrovascular complications were generally sparse. None of the included studies reported on QoL or socioeconomic effects.",2020,Pioglitazone compared with metformin neither showed advantage nor disadvantage regarding the development of T2DM in people at increased risk (low-certainty evidence).,"['participants diagnosed with intermediate hyperglycaemia with no concomitant diseases, comparing', '27 studies with a total of 4186 randomised participants', 'people at risk of developing T2DM']","['pioglitazone as monotherapy or part of dual therapy with other glucose-lowering drugs, behaviour-changing interventions, placebo or no intervention', 'pioglitazone with acarbose', 'pioglitazone with repaglinide', 'metformin', 'repaglinide', 'pioglitazone with placebo and with other glucose-lowering drugs', 'pioglitazone with placebo', 'placebo', 'pioglitazone', 'pioglitazone with metformin', 'acarbose', 'Pioglitazone']","['Incidence of T2DM', 'risk of T2DM by impaired fasting glucose or impaired glucose tolerance (IGT', 'cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, nonfatal myocardial infarction or stroke (NMI/S), health-related quality of life (QoL) and socioeconomic effects', 'cardiovascular mortality', 'QoL or socioeconomic effects', 'cardiovascular mortality, NMI/S, QoL or socioeconomic effects', 'advantage nor disadvantage regarding the development of T2DM', 'All-cause mortality', 'adverse event']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0243087', 'cui_str': 'concomitant disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",4186.0,0.370911,Pioglitazone compared with metformin neither showed advantage nor disadvantage regarding the development of T2DM in people at increased risk (low-certainty evidence).,"[{'ForeName': 'Emil Ørskov', 'Initials': 'EØ', 'LastName': 'Ipsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper S', 'Initials': 'KS', 'LastName': 'Madsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Pedersen-Bjergaard', 'Affiliation': 'Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Richter', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Maria-Inti', 'Initials': 'MI', 'LastName': 'Metzendorf', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013516.pub2']
2381,33208263,The effects of three cold plasma treatments on the osteogenic activity and antibacterial property of PEEK.,"OBJECTIVE


This study examines the differences in osteogenic activity and antibacterial property among polyetheretherketone (PEEK) treated by three types of cold plasma.
METHODS


Standard PEEK specimens were randomly assigned to four groups, which were named according to the treatment: PEEK-C (untreated), PEEK-A (Ar cold plasma treatment), PEEK-N (N 2  cold plasma treatment), and PEEK-AN (90% Ar and 10% N 2  mixed cold plasma treatment). Physical and chemical properties of the specimen surfaces were determined by scanning electron microscopy (SEM), atomic force microscopy (AFM), X-ray photoelectron spectroscopy (XPS) and drop shape analyzer (DSA). MC3T3 osteoblasts were used in vitro to determine the osteogenic activity by cell adhesion morphology observation, cell counting-kit 8 (CCK-8) assay, and alkaline phosphatase (ALP) activity assay. Streptococcus mutans and Staphylococcus aureus were used in vitro to determine the antibacterial property by a plate colony-counting method and bacterial adhesion morphology observation.
RESULTS


SEM and AFM analysis showed that the PEEK-C surface was smooth, whereas matrix-arranged nanoprotrusions appeared on the surface of the experimental groups: scaly nano-protrusions appeared on the PEEK-A and PEEK-AN surfaces, while dendritic nanoprotrusions appeared on the PEEK-N surface. Among the experimental groups, PEEK-AN had the finest surface nanoprotrusions. The roughness of the experimental groups increased compared with the PEEK-C group: the PEEK-N group was the roughest with a Ra of 192.60 ± 5.89 nm and PEEK-A was the smoothest with a Ra of 99.60 ± 5.43 nm. The hydrophilicity of the experimental groups was significantly enhanced compared with the PEEK-C group, among which, PEEK-N was the strongest and PEEK-A the weakest. The osteogenic activity and antibacterial property of the experimental groups displayed a remarkable increase compared with the PEEK-C group. Among the experimental groups, PEEK-N displayed the best osteogenic activity while PEEK-AN possessed the strongest antibacterial property. The osteogenic activity and antibacterial performance of PEEK-A were the weakest. Among these treatments, the N 2  cold plasma treatment was the most suitable modification method for PEEK application in dental implant.
SIGNIFICANCE


Cold plasma treatment is a promising method to improve PEEK osteogenic activity and antibacterial properties. This study provides a theoretical basis for future research on PEEK cold plasma treatment.",2020,The roughness of the experimental groups increased compared with the PEEK-C group: the PEEK-N group was the roughest with a Ra of 192.60 ± 5.89 nm and PEEK-A was the smoothest with a Ra of 99.60 ± 5.43 nm.,[],"['PEEK-A (Ar cold plasma treatment), PEEK-N (N 2  cold plasma treatment), and PEEK-AN', 'polyetheretherketone (PEEK']","['hydrophilicity', 'osteogenic activity by cell adhesion morphology observation, cell counting-kit 8 (CCK-8) assay, and alkaline phosphatase (ALP) activity assay', 'osteogenic activity and antibacterial property']",[],"[{'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C2936478', 'cui_str': 'Non-Thermal Atmospheric Pressure Plasma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0475370', 'cui_str': 'Hydrophilic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0172095,The roughness of the experimental groups increased compared with the PEEK-C group: the PEEK-N group was the roughest with a Ra of 192.60 ± 5.89 nm and PEEK-A was the smoothest with a Ra of 99.60 ± 5.43 nm.,"[{'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China; Department of Pediatric Dentistry, Yantai Stomatological Hospital, 142 North Street, Yantai 264008, PR China. Electronic address: 1377708594@qq.com.'}, {'ForeName': 'Jianfei', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China. Electronic address: 2560917249@qq.com.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China. Electronic address: 1165349590@qq.com.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China. Electronic address: 2062727219@qq.com.'}, {'ForeName': 'Defei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China. Electronic address: 806650230@qq.com.'}, {'ForeName': 'Shanling', 'Initials': 'S', 'LastName': 'Ni', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China. Electronic address: nishanling@163.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of General Dentistry, School and Hospital of Stomatology, Jilin University, 1500 Qing Hua Road, Changchun 130021, PR China. Electronic address: jdliuhong@163.com.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.10.007']
2382,33208301,"Live video adaptations to a mind-body activity program for chronic pain and cognitive decline: Protocol for the ""Virtual Active Brains"" study.","BACKGROUND


Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, highly prevalent among older adults, and worsen each other over time. We are iteratively developing Active-Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count aided by a Fitbit. AB-F has demonstrated feasibility, acceptability, and signals of improvement in emotional, physical, and cognitive function when delivered in-person to this population.
OBJECTIVE


We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (Health Enhancement Program; HEP) in older adults with CP and CD. Due to COVID-19 and qualitative feedback from former participants, both programs are delivered in an entirely virtual format via live video (Zoom). Here, we describe our virtual study protocol, manualized treatments, evaluation plan, and study design. We will evaluate feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive function.
METHODS


This is a single-blind pilot RCT. Participants are randomized to one of two programs: AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and IRB-approved flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate sealed envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via secure live video. Participants complete self-report and performance-based (6-minute walk test, Montreal Cognitive Assessment) outcome measures via live video at baseline and post-intervention. Primary outcomes are a-priori set feasibility (recruitment, quantitative measures, adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional function, as well as intervention targets (social function, pain intensity, pain-specific coping, mindfulness).
RESULTS


The trial is ongoing. We have recruited 21 participants (10 AB-F, 11 HEP) across two rounds. Only two participants have withdrawn (1 before baseline, 1 before first session). All 19 remaining participants have completed the baseline. In the first round, attendance is high (11/12 completed all 4 sessions so far) and AB-F participants are adherent to their Fitbit and step goals (5/6).
CONCLUSIONS


Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention but need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body and activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for the virtual assessments and intervention delivery will inform treatment development for older adults generally and those with CP-CD specifically, during the COVID-19 pandemic and beyond.
CLINICALTRIAL


ClinicalTrial.gov NCT04044183.",2020,"AB-F has demonstrated feasibility, acceptability, and signals of improvement in emotional, physical, and cognitive function when delivered in-person to this population.
","['older adults', 'older adults with comorbid CP and CD', '21 participants (10 AB-F, 11 HEP) across two rounds', 'older adults with CP and CD', 'Patients are recruited through pain clinic referrals, institutional registries, and IRB-approved flyers']","['completely virtual mind-body and activity program', 'Live video adaptations to a mind-body activity program', 'AB-F or HEP', 'AB-F versus a time- and dose-matched educational control (Health Enhancement Program; HEP']","['Participants complete self-report and performance-based (6-minute walk test, Montreal Cognitive Assessment) outcome measures via live video', 'priori set feasibility (recruitment, quantitative measures, adherence), acceptability, credibility, expectancy, and satisfaction benchmarks', 'physical, cognitive, and emotional function, as well as intervention targets (social function, pain intensity, pain-specific coping, mindfulness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205540', 'cui_str': 'Approved'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",21.0,0.0890067,"AB-F has demonstrated feasibility, acceptability, and signals of improvement in emotional, physical, and cognitive function when delivered in-person to this population.
","[{'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Mace', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Sq1st floor, Suite 100, Boston, US.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Doorley', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Sq1st floor, Suite 100, Boston, US.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Popok', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, US.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Sq1st floor, Suite 100, Boston, US.'}]",JMIR research protocols,['10.2196/25351']
2383,33208303,Development in PaCO 2  over 12 months in patients with COPD with persistent hypercapnic respiratory failure treated with high-flow nasal cannula-post-hoc analysis from a randomised controlled trial.,"INTRODUCTION


Persistent hypercapnic failure in chronic obstructive pulmonary disease (COPD) is associated with poor prognosis. Long-term home non-invasive ventilation is recommended for patients with PaCO 2  >7.0 kPa. Domiciliary high-flow nasal cannula (HFNC) reduces PaCO 2  in short-term studies. This post-hoc analysis examines the effect of HFNC on PaCO 2  levels, exacerbations and admissions in patients with COPD with persistent hypercapnic and hypoxic failures.
METHODS


The original trial included 74 long-term oxygen-treated patients (31 HFNC treated/43 controls) with persistent hypercapnic failure (PaCO 2  >6 kPa) who completed the 12-month study period. Baseline data included age, sex, blood gases, exacerbations and hospital admissions in the previous year. Data on blood gases were also recorded at 6 and 12 months for all patients. In addition, acute changes in blood gases after 30 min of HFNC use at site visits were examined, as were exacerbations and hospital admissions during study.
RESULTS


Patients were comparable at baseline. After 12 months there was a 1.3% decrease in PaCO 2  in patients using HFNC and a 7% increase in controls before HFNC use on site (p=0.003). After 30 min of HFNC at visits PaCO 2  changed significantly, with comparable reductions, at 0, 6 and 12 months, including for controls who tried HFNC at study end (p<0.001). The exacerbation rate increased, compared with 12 months prestudy, by 2.2/year for controls (p<0.001) and 0.15/year for HFNC-treated patients (p=0.661). Hospital admission rates increased in the control group,+0.3/year from prestudy (p=0.180), And decreased by 0.67/year (p=0.013)for HFNC-treated patients.
CONCLUSION


This post-hoc analysis indicates that HFNC stabilises patients with COPD with persistent hypoxic and hypercapnic failures, in terms of PaCO 2 , exacerbations and number of hospitalisations, whereas those not receiving HFNC worsened. This suggests that HFNC is a possible treatment for patients with persistent hypercapnic COPD.",2020,"Hospital admission rates increased in the control group,+0.3/year from prestudy (p=0.180), And decreased by 0.67/year (p=0.013)for HFNC-treated patients.
","['74 long-term oxygen-treated patients (31 HFNC treated/43 controls) with persistent hypercapnic failure (PaCO 2  >6\u2009kPa) who completed the 12-month study period', 'patients with persistent hypercapnic COPD', 'patients with PaCO 2  >7.0\u2009kPa', 'chronic obstructive pulmonary disease (COPD', 'patients with COPD with persistent hypercapnic respiratory failure', 'patients with COPD with persistent hypercapnic and hypoxic failures']","['HFNC', 'Domiciliary high-flow nasal cannula (HFNC']","['Hospital admission rates', 'blood gases', 'exacerbation rate', 'PaCO']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0338047', 'cui_str': 'Domiciliary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}]",74.0,0.183511,"Hospital admission rates increased in the control group,+0.3/year from prestudy (p=0.180), And decreased by 0.67/year (p=0.013)for HFNC-treated patients.
","[{'ForeName': 'Line Hust', 'Initials': 'LH', 'LastName': 'Storgaard', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Hockey', 'Affiliation': 'Biometric Matters Limited, Hamilton, New Zealand.'}, {'ForeName': 'Ulla Møller', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, North Denmark Region, Denmark ulw@rn.dk.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000712']
2384,33208325,"Biofortification of wheat with zinc for eliminating deficiency in Pakistan: study protocol for a cluster-randomised, double-blind, controlled effectiveness study (BIZIFED2).","INTRODUCTION


Micronutrient deficiencies, commonly referred to as 'hidden hunger', affect more than two billion people worldwide, with zinc and iron-deficiency frequently reported. The aim of this study is to examine the impact of consuming zinc biofortified flour (Zincol-2016) on biochemical and functional measures of status in adolescent girls and children living in a low-resource setting in Pakistan.
METHODS AND ANALYSIS


We are conducting a pragmatic, cluster-randomised, double-blind, controlled trial. A total of 482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar. Household inclusion criteria are the presence of both an adolescent girl, aged 10-16 years, and a child aged 1-5 years. The study duration is 12 months, divided into two 6-month phases. During phase 1, all households will be provided with locally procured flour from standard varieties of wheat. During phase 2, clusters will be paired, and randomised to either the control or intervention arm of the study. The intervention arm will be provided with zinc biofortified wheat flour, with a target zinc concentration of 40 mg/kg. The control arm will be provided with locally procured wheat flour from standard varieties with an expected zinc concentration of 20 mg/kg. The primary outcome measure is plasma zinc concentration. Secondary outcomes include anthropometric measurements, biomarkers of iron and zinc status, and the presence and duration of respiratory tract infections and diarrhoea.
ETHICS AND DISSEMINATION


Ethical approval was granted from the University of Central Lancashire STEMH Ethics Committee (reference number: STEMH 1014) and Khyber Medical University Ethics Committee (DIR/KMU-EB/BZ/000683). The final study methods will be published in peer-reviewed journals, alongside the study outcomes. In addition, findings will be disseminated to the scientific community via conference presentations and abstracts and communicated to the study participants through the village elders at an appropriate community forum.
TRIAL REGISTRATION NUMBER


ISRCTN17107812; Pre-results.",2020,A total of 482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar.,"['adolescent girls and children living in a low-resource setting in Pakistan', '482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar', 'participants through the village elders at an appropriate community forum', 'Household inclusion criteria are the presence of both an adolescent girl, aged 10-16 years, and a child aged 1-5 years']","['wheat with zinc', 'consuming zinc biofortified flour (Zincol-2016']","['anthropometric measurements, biomarkers of iron and zinc status, and the presence and duration of respiratory tract infections and diarrhoea', 'plasma zinc concentration']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",482.0,0.535024,A total of 482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar.,"[{'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Lowe', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK NMLowe@uclan.ac.uk.'}, {'ForeName': 'Mukhtiar', 'Initials': 'M', 'LastName': 'Zaman', 'Affiliation': 'Department of Pulmonology, Rehman Medical Institute, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Victoria Hall', 'Initials': 'VH', 'LastName': 'Moran', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ohly', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sinclair', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Fatima', 'Affiliation': 'Institute of Basic Medical sciences, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Broadley', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Edward J M', 'Initials': 'EJM', 'LastName': 'Joy', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Mahboob', 'Affiliation': 'Institute of Health Professions Education and Research, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'R Murray', 'Initials': 'RM', 'LastName': 'Lark', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Munir H', 'Initials': 'MH', 'LastName': 'Zia', 'Affiliation': 'Research and Development, Fauji Fertilizer Co Ltd, Rawalpindi, Punjab, Pakistan.'}, {'ForeName': 'E Louise', 'Initials': 'EL', 'LastName': 'Ander', 'Affiliation': 'Inorganic Chemistry, Centre for Environmental Geochemistry, British Geological Survey, Nottingham, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Sharp', 'Affiliation': 'Nutritional Sciences, Kings College London, London, UK.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Bailey', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Muhammad Jaffar', 'Initials': 'MJ', 'LastName': 'Khan', 'Affiliation': 'Institute of Basic Medical sciences, Khyber Medical University, Peshawar, Pakistan.'}]",BMJ open,['10.1136/bmjopen-2020-039231']
2385,33208583,A Prospective Randomized Study on the Preventive Effect of Japanese Herbal Kampo Medicine Goreisan for Recurrence of Chronic Subdural Hematoma.,"Although the recurrence of chronic subdural hematoma (CSDH) after surgical treatment significantly affects the patients' quality of life, the recurrence rate has not improved in decades. Goreisan, a Japanese herbal Kampo medicine, promotes the hydragogue effect and has been empirically used in the treatment of CSDH in Japan. We conducted a prospective randomized study to investigate whether Goreisan treatment decreases the recurrence rate of CSDH. Between March 2013 and December 2018, a total of 224 patients who underwent initial burr hole surgery for CSDH were randomly assigned to receive Goreisan for 3 months (Group G) or no medication (Group N). The primary endpoint was symptomatic recurrence within 3 months postoperatively, and the secondary endpoint was complications, including the adverse effects of Goreisan. Of 224 randomized patients, 208 were included in the final analysis (104 in Group G and 104 in Group N). The overall recurrence rate was 9.1% (19/208). The recurrence rate of Group G was lower than that of Group N (5.8% vs 12.5%, P = 0.09), but the difference was not statistically significant. However, a significant preventive effect of Goreisan was found in 145 patients with high-risk computed tomography (CT) features, namely, homogeneous and separated types (5.6% vs 17.6%, P = 0.04). Although the present study did not prove the beneficial effect of Goreisan treatment, it suggested the importance of selecting patients with an increased risk of recurrence. A subset of patients whose hematoma showed homogeneous and separated patterns on CT image might benefit from Goreisan treatment.",2020,"The recurrence rate of Group G was lower than that of Group N (5.8% vs 12.5%, P = 0.09), but the difference was not statistically significant.","['224 randomized patients, 208 were included in the final analysis (104 in Group G and 104 in Group N', 'Between March 2013 and December 2018, a total of 224 patients who underwent initial burr hole surgery for CSDH', '145 patients with high-risk computed tomography (CT']","['no medication', 'Japanese Herbal Kampo Medicine Goreisan']","['recurrence of chronic subdural hematoma (CSDH', 'recurrence rate of CSDH', 'overall recurrence rate', 'recurrence rate of Group G', 'symptomatic recurrence', 'adverse effects of Goreisan', 'quality of life, the recurrence rate']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0752221', 'cui_str': 'Kampo Medicine'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",145.0,0.0387963,"The recurrence rate of Group G was lower than that of Group N (5.8% vs 12.5%, P = 0.09), but the difference was not statistically significant.","[{'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Fujisawa', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Oya', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Indo', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': 'Department of Neurosurgery, Saitama Medical Center, Saitama Medical University.'}]",Neurologia medico-chirurgica,['10.2176/nmc.oa.2020-0287']
2386,33208640,"Prospective, Blinded, Randomized Controlled Trial of Stemless Versus Stemmed Humeral Components in Anatomic Total Shoulder Arthroplasty: Results at Short-Term Follow-up.","BACKGROUND


Stemless humeral components for anatomic total shoulder arthroplasty (aTSA) have several reported potential benefits compared with stemmed implants. However, we are aware of no Level-I, randomized controlled trials (RCTs) that have compared stemless implants with stemmed implants in patients managed with aTSA. We sought to directly compare the short-term clinical and radiographic outcomes of stemless and stemmed implants to determine if the stemless implant is noninferior to the stemmed implant.
METHODS


We performed a prospective, multicenter, single-blinded RCT comparing stemless and short-stemmed implants in patients managed with aTSA. Range-of-motion measurements and American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores were obtained at multiple time points. Device-related complications were recorded. Radiographic evaluation for evidence of loosening, fractures, dislocation, or other component complications was performed. Statistical analysis for noninferiority was performed at 2 years of follow-up for 3 primary end points: ASES score, absence of device-related complications, and radiographic signs of loosening. All other data were compared between cohorts at all time points as secondary measures.
RESULTS


Two hundred and sixty-five shoulders (including 176 shoulders in male patients and 89 shoulders in female patients) were randomized and received the allocated treatment. The mean age of the patients (and standard deviation) was 62.6 ± 9.3 years, and 99% of the shoulders had a primary diagnosis of osteoarthritis. At 2 years, the mean ASES score was 92.5 ± 14.9 for the stemless cohort and 92.2 ± 13.5 for the stemmed cohort (p value for noninferiority test, <0.0001), the proportion of shoulders without device-related complications was 92% (107 of 116) for the stemless cohort and 93% (114 of 123) for the stemmed cohort (p value for noninferiority test, 0.0063), and no shoulder in either cohort had radiographic signs of loosening. Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up.
CONCLUSIONS


At 2 years of follow-up, the safety and effectiveness of the stemless humeral implant were noninferior to those of the stemmed humeral implant in patients managed with aTSA for the treatment of osteoarthritis. These short-term results are promising given the potential benefits of stemless designs over traditional, stemmed humeral components.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up.
","['mean age of the patients (and standard deviation) was 62.6 ± 9.3 years, and 99% of the shoulders had a primary diagnosis of osteoarthritis', 'Anatomic Total Shoulder Arthroplasty', 'Two hundred and sixty-five shoulders (including 176 shoulders in male patients and 89 shoulders in female patients', 'patients managed with aTSA']","['aTSA', 'Stemless Versus Stemmed Humeral Components']","['proportion of shoulders without device-related complications', 'Range-of-motion measurements and American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores', 'radiographic signs of loosening', 'mean ASES score', 'ASES score, absence of device-related complications, and radiographic signs of loosening', 'safety and effectiveness', 'Range-of-motion measurements and ASES, SANE, and Constant scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.214757,"Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up.
","[{'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Wiater', 'Affiliation': 'Department of Orthopedic Surgery, William Beaumont Hospital, Beaumont Health, Royal Oak, Michigan.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Levy', 'Affiliation': 'Holy Cross Orthopedic Research Institute, Fort Lauderdale, Florida.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wright', 'Affiliation': 'Orthopaedics Northeast, Parkview Orthopaedic Hospital, Fort Wayne, Indiana.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Brockmeier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Duquin', 'Affiliation': 'Department of Orthopaedic Surgery, Jacobs School of Medicine, University at Buffalo, The State University of New York, Buffalo, New York.'}, {'ForeName': 'Jonathan O', 'Initials': 'JO', 'LastName': 'Wright', 'Affiliation': 'Department of Orthopedic Surgery, William Beaumont Hospital, Beaumont Health, Royal Oak, Michigan.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Codd', 'Affiliation': ""Department of Orthopaedic Surgery, University of Maryland Medical System and St Joseph's Hospital, Towson, Maryland.""}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01478']
2387,33208641,"Single-Shot Liposomal Bupivacaine Reduces Postoperative Narcotic Use Following Outpatient Rotator Cuff Repair: A Prospective, Double-Blinded, Randomized Controlled Trial.","BACKGROUND


Liposomal bupivacaine (LB) theoretically is longer-acting compared with conventional bupivacaine. The purpose of this study was to compare conventional bupivacaine combined with dexamethasone (control group), LB combined with conventional bupivacaine (LB group), and LB combined with dexamethasone and conventional bupivacaine (LBD group) in a perineural interscalene nerve block during ambulatory arthroscopic rotator cuff repair to determine if LB decreased postoperative narcotic consumption and pain. The effect of supplemental dexamethasone on prolonging the analgesic effect of LB was also assessed.
METHODS


This was a prospective, double-blinded, randomized controlled trial of 76 consecutive patients who underwent outpatient arthroscopic rotator cuff repair. Patients were randomized into the 3 interscalene-block treatment groups: control group (n = 26), LB group (n = 24), and LBD group (n = 26). Outcome measures included pain measured with a visual analog scale (VAS; 0 to 10) and narcotic consumption measured in oral morphine milligram equivalents (MME). Both were measured daily on postoperative day 0 through postoperative day 4.
RESULTS


Generalized estimating equation modeling revealed that narcotic consumption across all time points (postoperative days 0 to 4) was significantly lower in the LB group compared with the control group (mean difference, -8.5 MME; 95% confidence interval, -15.4 to -1.6; p = 0.015). Narcotic consumption was significantly higher in the control group on postoperative days 2 and 3 compared with the LB group (p = 0.004 and p = 0.02, respectively) and the LBD group (p = 0.01 and p = 0.003, respectively). There was no difference in narcotic consumption between the LBD and LB groups on any postoperative day. VAS pain scores in all groups were similar across all postoperative days.
CONCLUSIONS


Among patients undergoing outpatient arthroscopic rotator cuff repair, the addition of LB to conventional bupivacaine in interscalene nerve blocks appeared to be effective in controlling postoperative pain. Because LB with and without dexamethasone decreased postoperative narcotic use, LB should be considered for use in preoperative interscalene nerve blocks to reduce the reliance on narcotics for pain management.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Narcotic consumption was significantly higher in the control group on postoperative days 2 and 3 compared with the LB group (p = 0.004 and p = 0.02, respectively) and the LBD group (p = 0.01 and p = 0.003, respectively).","['patients undergoing outpatient arthroscopic rotator cuff repair', '76 consecutive patients who underwent outpatient arthroscopic rotator cuff repair', 'Outpatient Rotator Cuff Repair']","['bupivacaine', 'conventional bupivacaine', 'LBD', 'Single-Shot Liposomal Bupivacaine', 'dexamethasone', 'Liposomal bupivacaine (LB', 'dexamethasone (control group), LB combined with conventional bupivacaine (LB group), and LB combined with dexamethasone and conventional bupivacaine (LBD group', 'supplemental dexamethasone']","['Narcotic consumption', 'postoperative narcotic consumption and pain', 'Postoperative Narcotic Use', 'narcotic consumption', 'pain measured with a visual analog scale (VAS; 0 to 10) and narcotic consumption measured in oral morphine milligram equivalents (MME', 'analgesic effect of LB', 'VAS pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0751783', 'cui_str': 'Lafora disease'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",76.0,0.336994,"Narcotic consumption was significantly higher in the control group on postoperative days 2 and 3 compared with the LB group (p = 0.004 and p = 0.02, respectively) and the LBD group (p = 0.01 and p = 0.003, respectively).","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Baessler', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Moor', 'Affiliation': 'Department of Medical and Population Health Sciences Research, Herbert Wertheim College of Medicine, Florida International University, Miami, Florida.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Conrad', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Creighton', 'Affiliation': 'EmergeOrtho Triad Region, Greensboro, North Carolina.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Badman', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00225']
2388,33208642,Usefulness of an Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty: A Multicenter Prospective Randomized Controlled Trial.,"BACKGROUND


An accelerometer-based portable navigation system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter prospective randomized controlled trial (RCT) was to evaluate the effects of this accelerometer-based portable navigation system for achieving more accurate alignment during TKA in the clinical setting.
METHODS


One hundred patients with primary varus osteoarthritis of the knee were enrolled in this prospective RCT conducted in 5 hospitals. A navigation system was utilized in 50 patients (navigation group), and a conventional intramedullary femoral guide and an extramedullary tibial guide were utilized in 50 patients (conventional group). At 6 months postoperatively, weight-bearing radiographs were obtained of the whole operative leg. An experienced surgeon who was blinded to the treatment assignments then measured the alignment to 1 decimal place with use of computer software. Power analysis showed that 41 knees were required in each group.
RESULTS


There were no complications as a result of the use of the accelerometer-based portable navigation system. Postoperative radiographs were obtained in 45 patients from each group. There were no significant differences in sex, age, height, body weight, body mass index, preoperative femorotibial angle, and operative time between groups. The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group. Alignment outliers (>2° away from the neutral mechanical axis) of the tibial prosthesis and hip-knee-ankle angle were less in the navigation group (9% and 27%, respectively) compared with those in the conventional group (31% and 49%; p = 0.01 and p = 0.04, respectively).
CONCLUSIONS


To our knowledge, this is the first multicenter prospective RCT to evaluate an accelerometer-based portable navigation system. An accelerometer-based portable navigation system provides more accurate prosthetic and limb alignment in the coronal plane than conventional techniques, without extended operative time or an increased rate of complications. The results of this study may help orthopaedic surgeons decide whether or not to use an accelerometer-based portable navigation system.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group.","['total knee arthroplasty (TKA', 'One hundred patients with primary varus osteoarthritis of the knee were enrolled in this prospective RCT conducted in 5 hospitals', '50 patients (navigation group', 'Total Knee Arthroplasty']","['accelerometer-based portable navigation system', 'conventional intramedullary femoral guide and an extramedullary tibial guide', 'Accelerometer-Based Portable Navigation System']","['sex, age, height, body weight, body mass index, preoperative femorotibial angle, and operative time', 'Postoperative radiographs', 'hip-knee-ankle angle', 'neutral mechanical axis', 'tibial prosthesis', 'tibial prosthesis and hip-knee-ankle angle', 'rate of complications', 'femoral prosthesis']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1512957', 'cui_str': 'Intramedullary route'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",100.0,0.0579581,"The absolute differences of the femoral prosthesis (p = 0.01), tibial prosthesis (p < 0.01), and hip-knee-ankle angle (p < 0.01) from a neutral mechanical axis were less in the navigation group compared with those in the conventional group.","[{'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Minoda', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kazue', 'Initials': 'K', 'LastName': 'Hayakawa', 'Affiliation': 'Department of Orthopaedic Surgery, Fujita Health University, Toyoake, Aichi, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hagio', 'Affiliation': 'Department of Orthopaedic Surgery, Osaka Minami Medical Center, Kawachinagano, Osaka, Japan.'}, {'ForeName': 'Natsuo', 'Initials': 'N', 'LastName': 'Konishi', 'Affiliation': 'Department of Orthopaedic Surgery, Akita Kousei Medical Center, Akita, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Tamaki', 'Affiliation': 'Department of Orthopaedic Surgery, Funabashi Orthopaedic Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Orthopaedic Surgery, Shiraniwa Hospital, Ikoma, Nara, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00387']
2389,33208649,"Considering the Value of Imageless, Accelerometer-Based, Intraoperative Mini-Navigation Systems in Contemporary Primary Total Knee Arthroplasty: Commentary on an article by Yukihide Minoda, MD, PhD, et al.: ""Usefulness of an Accelerometer-Based Portable Navigation System for Total Knee Arthroplasty. A Multicenter Prospective Randomized Controlled Trial"".",,2020,,"['Total Knee Arthroplasty', 'Contemporary Primary Total Knee Arthroplasty']",['Accelerometer-Based Portable Navigation System'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}]",[],,0.0447297,,"[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Kurmis', 'Affiliation': 'Discipline of Medical Specialties, Division of Health Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01534']
2390,33208652,Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial.,"OBJECTIVE


Urodynamic testing of women is a common procedure to evaluate lower urinary tract symptoms but may cause discomfort. The objective of our study was to determine the effect of externally applied periurethral 2% lidocaine gel on pain scores after complex urodynamic testing in women.
METHODS


This prospective, double-blinded, placebo-controlled randomized trial compared 2% lidocaine gel to water-based lubricant applied to the periurethral area before urodynamic testing in women. Discomfort was measured using a visual analog pain scale (VAS) ranging from 0 to 100. The primary outcome was the difference in VAS from baseline to 4 to 6 hours after urodynamic testing. Secondary outcomes included: VAS difference from baseline to immediately postprocedure and 24 hours after urodynamic testing; VAS scores: at baseline, immediately postprocedure, after 4-6 hours, and after 24 hours; urodynamic testing results; and any adverse events. Sixty-four women per group were needed to provide a power of 80% to detect a 10-mm difference on a 100-point VAS.
RESULTS


From January 2018 to March 2019, 134 subjects were randomized, 6 subjects were excluded, which resulted in 64 subjects in both the water-based lubricant group and 2% lidocaine gel group. There was no difference in baseline demographics. There was no significant difference in the change in VAS from baseline to 4 to 6 hours after UDT (0, 0 P = 0.88). No difference in secondary outcomes was noted.
CONCLUSIONS


Topically applied 2% lidocaine gel does not decrease pain compared with water-based lubricant. For most women, complex urodynamic testing is not associated with any significant pain.
CLINICAL TRIAL REGISTRATION


www.ClinicalTrials.gov,-NCT03390790, ""Lidocaine for Pain After Urodynamic Testing"".",2020,"There was no significant difference in the change in VAS from baseline to 4 to 6 hours after UDT (0, 0 P = 0.88).","['Women', 'women', 'From January 2018 to March 2019, 134 subjects were randomized, 6 subjects were excluded, which resulted in 64 subjects in both the water-based lubricant group and 2']","['lidocaine gel', 'lidocaine gel to water-based lubricant', 'placebo', 'Periurethral Lidocaine', 'Lidocaine']","['VAS', 'VAS difference from baseline to immediately postprocedure and 24 hours after urodynamic testing; VAS scores', 'adverse events', 'Discomfort', 'visual analog pain scale (VAS', 'Pain', 'change in VAS', 'pain scores', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",134.0,0.563646,"There was no significant difference in the change in VAS from baseline to 4 to 6 hours after UDT (0, 0 P = 0.88).","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Avondstondt', 'Affiliation': ""From the Department of Obstetrics, Gynecology and Women's Health.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': 'Atlantic Center for Research, Atlantic Health System, Morristown, NJ.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Salamon', 'Affiliation': ""From the Department of Obstetrics, Gynecology and Women's Health.""}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000983']
2391,33208658,Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial.,"OBJECTIVE


The aim of the study was to assess whether home biofeedback is noninferior to supervised pelvic floor physical therapy (PFPT) for the treatment of stress urinary incontinence (SUI) in women.
METHODS


The study used a randomized controlled noninferiority trial to compare a home biofeedback device with PFPT. Women older than 18 years with SUI and no history of a prior incontinence surgery or PFPT were eligible. Forty-two participants were required to determine noninferiority for the primary outcome, improvement in quality of life as measured by the International Consultation on Incontinence Questionnaire Short Form. The noninferiority margin was 4 points. Secondary outcomes included sexual function, overactive bladder symptoms, and patient impression of improvement.
RESULTS


From June 2018 to October 2019, 54 women with SUI were recruited (27 biofeedback, 27 PFPT) and 43 (21 biofeedback, 22 PFPT) completed follow-up. The groups had comparable baseline characteristics. For the primary outcome of change in mean International Consultation on Incontinence Questionnaire-Short Form scores (where lower scores indicate less incontinence), home biofeedback was found to be noninferior to PFPT with a mean decrease from baseline of -3.95 (95% confidence interval [CI] = -2.21 to -5.70) in the home biofeedback group versus -4.73 (95% CI = -3.21 to -6.25) and -3.95 (95% CI = -2.21 to -5.70) in the PFPT group (P = 0.009). The PFPT group showed more improvement in overactive bladder symptoms, but not in incontinence severity without difference in sexual function.
CONCLUSIONS


Home biofeedback was noninferior to PFPT for the primary treatment of SUI in women at 3 months. These results support the use of personal biofeedback devices for the treatment of SUI.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT03443687.",2020,"The PFPT group showed more improvement in overactive bladder symptoms, but not in incontinence severity without difference in sexual function.
","['Stress Urinary Incontinence', 'From June 2018 to October 2019, 54 women with SUI were recruited (27 biofeedback, 27 PFPT) and 43 (21 biofeedback, 22 PFPT) completed follow-up', 'Women older than 18 years with SUI and no history of a prior incontinence surgery or PFPT were eligible', 'stress urinary incontinence (SUI) in women']","['supervised pelvic floor physical therapy (PFPT', 'PFPT', 'home biofeedback device with PFPT', 'Home Biofeedback Versus Physical Therapy']","['mean International Consultation on Incontinence Questionnaire-Short Form scores', 'overactive bladder symptoms', 'quality of life as measured by the International Consultation on Incontinence Questionnaire Short Form', 'sexual function, overactive bladder symptoms, and patient impression of improvement']","[{'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0179310', 'cui_str': 'Biofeedback system'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",54.0,0.227248,"The PFPT group showed more improvement in overactive bladder symptoms, but not in incontinence severity without difference in sexual function.
","[{'ForeName': 'Kara Lauren', 'Initials': 'KL', 'LastName': 'Barnes', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health Science Center, Albuquerque, NM.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cichowski', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Oregon Health & Science University School of Medicine, Portland, OR.'}, {'ForeName': 'Yuko M', 'Initials': 'YM', 'LastName': 'Komesu', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health Science Center, Albuquerque, NM.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Jeppson', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health Science Center, Albuquerque, NM.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'McGuire', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health Science Center, Albuquerque, NM.'}, {'ForeName': 'Cara S', 'Initials': 'CS', 'LastName': 'Ninivaggio', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health Science Center, Albuquerque, NM.'}, {'ForeName': 'Gena C', 'Initials': 'GC', 'LastName': 'Dunivan', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico Health Science Center, Albuquerque, NM.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000993']
2392,33208662,Evaluation of Longitudinal and Tubular Compression Treatment for Lower Limb Edema.,"BACKGROUND


Many patients with lower limb edema do not tolerate traditional higher-pressure compression devices and require alternative devices for edema control.
METHODS


Two systems were evaluated for control of bilateral or unilateral lower limb edema: an elasticized longitudinal stockinette (ELS; EdemaWear; Compression Dynamics, Omaha, Nebraska) and an elasticized tubular bandage (ETB; Tubigrip; Mölnlycke Health Care, Norcross, Georgia). Twenty-five patients were recruited; patients with bilateral edema (n = 12) wore the ELS on one limb, and the ETB on the other. Patients with unilateral edema (n = 13) were randomized to wear either the ELS or ETB. Edema measurements, leg pain, and patient preference were recorded.
RESULTS


There were 14 females (56%) and 11 males (44%); mean age was 66 years (range, 32-88 years); and mean body mass index was 40.4 kg/m (range, 26.1-66.9 kg/m). Patients with bilateral edema wearing ELS had a foot-to-leg circumference between 25.5 and 42.9 cm pre-ELS that remained essentially unchanged at 2 weeks. The five patients with unilateral edema using ELS had a 24.3- to 43.7-cm circumference pre-ELS and 24.2- to 42.6-cm range at 2 weeks. The patients with bilateral edema using ETBs had a foot-to-leg circumference of 25.5 to 43.7 cm before treatment, unchanged 2 weeks later. The eight patients with unilateral edema using ETB had a 25.4- to 45.3-cm circumference pre-ETB and 24.8- to 42.0-cm range post-ETB. Mean pain levels decreased from 1.0 at week 0 to 0.5 at week 2. More patients preferred ELS (17/23, 78.3%) over ETB (5/23, 21.7%).
CONCLUSIONS


Both systems were easy to apply and provided low compression without increased pain. The ELS was preferred by more patients (78.3%) than ETB (21.7%).",2020,The ELS was preferred by more patients (78.3%) than ETB (21.7%).,"['Twenty-five patients were recruited; patients with bilateral edema (n = 12) wore the ELS on one limb, and the ETB on the other', 'five patients with unilateral edema using ELS had a 24.3- to 43.7-cm circumference pre-ELS and 24.2- to', 'Patients with unilateral edema (n = 13', 'patients with lower limb edema', 'There were 14 females (56%) and 11 males (44%); mean age was 66 years (range, 32-88 years); and mean body mass index was 40.4 kg/m (range, 26.1-66.9 kg/m', 'Lower Limb Edema']","['ELS or ETB', 'Longitudinal and Tubular Compression Treatment', 'elasticized longitudinal stockinette (ELS; EdemaWear; Compression Dynamics, Omaha, Nebraska) and an elasticized tubular bandage']","['Edema measurements, leg pain, and patient preference', 'Mean pain levels', 'foot-to-leg circumference', 'pain']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0183614', 'cui_str': 'Stockinette'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0175728', 'cui_str': 'Tubular bandage'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0239340', 'cui_str': 'Edema of lower extremity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0183614', 'cui_str': 'Stockinette'}, {'cui': 'C0175728', 'cui_str': 'Tubular bandage'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0027523', 'cui_str': 'Nebraska'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",13.0,0.0172352,The ELS was preferred by more patients (78.3%) than ETB (21.7%).,"[{'ForeName': 'R Gary', 'Initials': 'RG', 'LastName': 'Sibbald', 'Affiliation': 'R. Gary Sibbald, MD, DSc (Hons), MEd, BSc, FRCPC (Med Derm), FAAD, MAPWCA, JM, is Professor, Medicine and Public Health, University of Toronto, Toronto, Ontario, Canada; Director, International Interprofessional Wound Care Course and Masters of Science in Community Health (Prevention and Wound Care), Dalla Lana School of Public Health, University of Toronto; Project Lead, ECHO Ontario Skin and Wound Care; Previous President, World Union of Wound Healing Societies; co-Editor-in-Chief, Advances in Skin and Wound Care, Philadelphia, Pennsylvania. At the Toronto Regional Wound Healing Clinic, Mississauga, Canada, James A. Elliott, MMSc, is Project Manager, ECHO Ontario Skin and Wound Care; Patricia Coutts, RN, IIWCC-CAN, is Clinical Trials Coordinator, WoundPedia; and Reneeka Persaud-Jaimangal, MD, MScCH, IIWCC-CAN, is Clinical Coordinator, ECHO Ontario Skin and Wound Care. Acknowledgment: This was an investigator-initiated trial funded by an unrestricted educational grant from Compression Dynamics LLC, Omaha, Nebraska. The authors have disclosed no other financial relationships related to this article. Submitted March 7, 2019; accepted in revised form May 19, 2020.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Elliott', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Coutts', 'Affiliation': ''}, {'ForeName': 'Reneeka', 'Initials': 'R', 'LastName': 'Persaud-Jaimangal', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000720264.41419.38']
2393,33208665,"Scarring at Donor Sites after Split-Thickness Skin Graft: A Prospective, Longitudinal, Randomized Trial.","OBJECTIVE


To investigate if previous findings on the association between dressing treatments and subjective opinion on final donor site scar outcome using the Patient and Observer Scar Assessment Scale (POSAS) can be confirmed objectively. The previous study showed that patients dressed with hydrofiber covered with film were more satisfied with their donor site scars than patients receiving porcine xenograft or polyurethane foam dressings.
METHODS


Scar outcome measurements were assessed by a blinded observer using POSAS and the Cutometer dual MPA 580 device to measure the viscoelasticity of skin.
RESULTS


A total of 17 participants were included in this study, five of whom were treated with hydrofiber, six with polyurethane foam, and another six with porcine xenograft. There were no significant differences among groups in any of the POSAS items or in the viscoelasticity measurements made with the Cutometer.
CONCLUSIONS


The investigators could not confirm previous associations between dressing treatment and long-term donor site scars. No associations between donor sites' healing times and final scarring were found. Hypopigmentation was reported in 15 of 17 donor sites evaluated.",2020,"There were no significant differences among groups in any of the POSAS items or in the viscoelasticity measurements made with the Cutometer.
","['Scarring at Donor Sites after Split-Thickness Skin Graft', 'A total of 17 participants were included in this study, five of whom were treated with hydrofiber, six with polyurethane foam, and another six with porcine xenograft']",[],"['viscoelasticity of skin', 'healing times and final scarring']","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0071696', 'cui_str': 'polyurethane foam'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}]",[],"[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",17.0,0.0272409,"There were no significant differences among groups in any of the POSAS items or in the viscoelasticity measurements made with the Cutometer.
","[{'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Karlsson', 'Affiliation': 'In the Departments of Hand Surgery, Plastic Surgery and Burns, Linköping University, Sweden, Matilda Karlsson, BSN, RN, is Registered Nurse; Moustafa Elmasry, MD, PhD, is Consultant Plastic Surgeon; Ingrid Steinvall, PhD, RN, is Research Nurse; Folke Sjöberg, MD, PhD, is Director; and Pia Olofsson, MD, PhD, is Head of Department and Consultant Plastic Surgeon. Acknowledgments: The authors thank statistician Mats Fredriksson, occupational therapist Caroline Andersson, and the rest of the staff in their department. The authors have disclosed no financial relationships related to this article. Submitted October 2, 2019; accepted in revised form December 10, 2019.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Elmasry', 'Affiliation': ''}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Steinvall', 'Affiliation': ''}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Sjöberg', 'Affiliation': ''}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Olofsson', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000720256.45983.28']
2394,33208831,Experimental sleep disruption attenuates morphine analgesia: findings from a randomized trial and implications for the opioid abuse epidemic.,"Preclinical studies demonstrate that sleep disruption diminishes morphine analgesia and modulates reward processing. We sought to translate these preclinical findings to humans by examining whether sleep disruption alters morphine's analgesic and hedonic properties. We randomized 100 healthy adults to receive morphine versus placebo after two nights of undisturbed sleep (US) and two nights of forced awakening (FA) sleep disruption. Sleep conditions were counterbalanced, separated by a two-week washout. The morning after both sleep conditions, we tested cold pressor pain tolerance before and 40-min after double-blind injection of .08 mg/kg morphine or placebo. The primary outcome was the analgesia index, calculated as the change in cold pressor hand withdrawal latency (HWL) before and after drug injection. Secondary outcomes were ratings of feeling ""high,"" drug ""liking,"" and negative drug effects. We found a significant sleep condition by drug interaction on the analgesia index (95% CI - 0.57, - 0.001). After US, subjects receiving morphine demonstrated significantly longer HWL compared to placebo (95% CI 0.23, 0.65), but not after FA (95% CI - 0.05, 0.38). Morphine analgesia was diminished threefold under FA, relative to US. After FA, females (95% CI - 0.88, - 0.05), but not males (95% CI - 0.23, 0.72), reported decreased subjective ""high"" effects compared to US. After FA, females (95% CI 0.05, 0.27), but not males (95% CI - 0.10, 0.11), administered morphine reported increased negative drug effects compared to US. These data demonstrate that sleep disruption attenuates morphine analgesia in humans and suggest that sleep disturbed males may be at greatest risk for problematic opioid use.",2020,"After US, subjects receiving morphine demonstrated significantly longer HWL compared to placebo (95% CI 0.23, 0.65), but not after FA (95% CI - 0.05, 0.38).",['100 healthy adults'],"['undisturbed sleep (US) and two nights of forced awakening (FA) sleep disruption', 'morphine analgesia', 'morphine versus placebo', 'morphine or placebo', 'placebo', 'morphine']","['cold pressor pain tolerance', 'Morphine analgesia', 'analgesia index, calculated as the change in cold pressor hand withdrawal latency (HWL', 'longer HWL', 'subjective ""high"" effects', 'negative drug effects', 'analgesia index', 'ratings of feeling ""high,"" drug ""liking,"" and negative drug effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",100.0,0.238683,"After US, subjects receiving morphine demonstrated significantly longer HWL compared to placebo (95% CI 0.23, 0.65), but not after FA (95% CI - 0.05, 0.38).","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Smith', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA. msmith62@jhmi.edu.'}, {'ForeName': 'Chung Jung', 'Initials': 'CJ', 'LastName': 'Mun', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Remeniuk', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Finan', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Campbell', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'Luis F', 'Initials': 'LF', 'LastName': 'Buenaver', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Virginia Tech Carilion School of Medicine, Roanoke, VA, 24016, USA.'}, {'ForeName': 'Brook', 'Initials': 'B', 'LastName': 'Fulton', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'David Andrew', 'Initials': 'DA', 'LastName': 'Tompkins', 'Affiliation': 'Department of Psychiatry, UCSF School of Medicine, San Francisco, CA, 94110, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Tremblay', 'Affiliation': 'Edgybees Inc., Gaithersburg, MD, 20878, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Strain', 'Affiliation': 'Division of Behavioral Medicine, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, 5510 Nathan Shock Drive, Suite 100, Baltimore, MD, 21225, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, 90024, USA.'}]",Scientific reports,['10.1038/s41598-020-76934-1']
2395,33208855,Open-label placebos for menopausal hot flushes: a randomized controlled trial.,"This study investigated the efficacy of an open-label placebo (OLP) treatment for menopausal hot flushes. Women with at least five moderate or severe hot flushes per day were allocated to receive four weeks of OLP for twice a day or no-treatment. Intention-to-treat analyses included n = 100 women. In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p < 0.001, Cohen's d = 0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p = 0.02, Cohen's d = 0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p = 0.02, Cohen's d = 0.49). Twelve (24%) (vs. three [6%]) patients had 50% lesser hot flushes. Problem rating of hot flushes and subdomains of quality of life did not improve. After four weeks, the OLP group was further divided via randomization to continue or discontinue the treatment. Benefits were maintained at week 8 (log-transformed score: - 0.04 [- 0.06; 0.14], p = 0.45). There was no difference between taking placebos for 8 or 4 weeks (log-transformed score: 0.04 [- 0.17; 0.25], p = 0.73). Results indicate that open-label placebos may be an effective, safe alternative for menopausal hot flushes.",2020,"In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p < 0.001, Cohen's d = 0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p = 0.02, Cohen's d = 0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p = 0.02, Cohen's d = 0.49).","['Intention-to-treat analyses included n\u2009=\u2009100 women', 'menopausal hot flushes', 'Women with at least five moderate or severe hot flushes per day']","['Open-label placebos', 'open-label placebo (OLP', 'OLP']","['overall menopause-related quality of life', 'quality of life', 'hot flushes', 'hot flush frequency']","[{'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",100.0,0.191289,"In comparison to no-treatment, OLP reduced the log-transformed hot flush composite score (frequency × intensity) (mean difference in change: - 0.32, 95% CI [- 0.43; - 0.21], p < 0.001, Cohen's d = 0.86), hot flush frequency (- 1.12 [- 1.81; - 0.43], p = 0.02, Cohen's d = 0.51), and improved overall menopause-related quality of life (- 2.53 [- 4.17; - 0.89], p = 0.02, Cohen's d = 0.49).","[{'ForeName': 'Yiqi', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces, Hamburg, Germany. y.pan@uke.de.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies and the Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Kai J', 'Initials': 'KJ', 'LastName': 'Buhling', 'Affiliation': 'Department of Gynecological Endocrinology, Clinic of Gynecology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Nestoriuc', 'Affiliation': 'Department of Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces, Hamburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-77255-z']
2396,33208878,The impacts of acid suppression on duodenal microbiota during the early phase of severe acute pancreatitis.,"Duodenal dysbiosis may be potential infection risks in patients with severe acute pancreatitis (SAP). Acid-suppression drugs (ACDs) are widely used in SAP patients in Asian countries. However, the impact of ACDs on duodenal microbiota during the early phase of SAP is still unknown. This randomized controlled clinical trial evaluated the impacts of esomeprazole (Eso), one of ACDs on duodenal microbiota during the first week of SAP with duodenal aspirates culture and 16sRNA Illumina sequencing analysis. 66 patients were randomized as 1:1 ratio into Eso group (Eso 40 mg/day) and Eso-N group (no Eso). The occurrence of duodenal bacterial overgrowth (DBO) was significantly higher in Eso group (about 85%) than that in Eso-N group (about 42%). The duodenal microbiota of the SAP patients shifted away from that of the normal control. There were differences between the Eso-N and Eso groups including enriched abundances of the class Negativicutes, order Selenomonadales and genus Veillonella. Acid suppression significantly increased incidence of Candida oesophagitis (CE) by 8-folds but did not increase other infectious events. In conclusion, acid suppression greatly increased the occurrence of DBO, duodenal dysbiosis and CE during the first week of SAP. Restrictive use of acid-suppressing medications might be helpful to reduce CE and potential risk of pancreatic infection in SAP patients.Trial registration: Chictr.org, ChiCTR-IPR-16008301, Registered April 18 2016, http://www.chictr.org.cn/showproj.aspx?proj=14089 .",2020,The occurrence of duodenal bacterial overgrowth (DBO) was significantly higher in Eso group (about 85%) than that in Eso-N group (about 42%).,"['severe acute pancreatitis', 'SAP patients in Asian countries', 'patients with severe acute pancreatitis (SAP', '66 patients', 'SAP patients']","['acid suppression', 'Acid-suppression drugs (ACDs', 'acid-suppressing medications', 'esomeprazole (Eso']","['infectious events', 'occurrence of DBO, duodenal dysbiosis and CE', 'occurrence of duodenal bacterial overgrowth (DBO', 'Candida oesophagitis (CE', 'enriched abundances of the class Negativicutes, order Selenomonadales and genus Veillonella', 'duodenal microbiota']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C3658208', 'cui_str': 'Dysbiosis'}, {'cui': 'C0239295', 'cui_str': 'Candidiasis of the esophagus'}, {'cui': 'C3084169', 'cui_str': 'Negativicutes'}, {'cui': 'C3084167', 'cui_str': 'Selenomonadales'}, {'cui': 'C0042446', 'cui_str': 'Veillonella'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",66.0,0.0249265,The occurrence of duodenal bacterial overgrowth (DBO) was significantly higher in Eso group (about 85%) than that in Eso-N group (about 42%).,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Gastroenterology, West China Hospital, Sichuan University, Guoxue Alley 37#, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Zhiyin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Gastroenterology, West China Hospital, Sichuan University, Guoxue Alley 37#, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jinsun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ""Department of Clinical Research Management Clerk, West China Hospital, Sichuan University, Guoxue Alley 37#, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Tong', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jinhang', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, West China Hospital, Sichuan University, Guoxue Alley 37#, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, West China Hospital, Sichuan University, Guoxue Alley 37#, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': ""Department of Gastroenterology, West China Hospital, Sichuan University, Guoxue Alley 37#, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China. lingzipurple@163.com.""}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': ""Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, People's Republic of China. shcqcdmed@163.com.""}]",Scientific reports,['10.1038/s41598-020-77245-1']
2397,33210604,"Impact of magnesium supplementation, in combination with vitamin B6, on stress and magnesium status: secondary data from a randomized controlled trial.","Primary findings from a recent study reported that magnesium supplementation significantly reduced stress in severely stressed subjects with low magnesemia, and additional vitamin B6 enhanced this effect. The mechanism by which combining magnesium and vitamin B6 leads to reduced stress in these subjects remains to be elucidated. This secondary analysis investigated the impact of magnesium and vitamin B6 supplementation and perceived stress on erythrocyte magnesium levels, as a marker of body magnesium status. This was a secondary analysis from an 8-week randomized controlled trial comparing oral magnesium (300 mg) and magnesium-vitamin B6 (300 mg + 30 mg) supplementation. Stress level and erythrocyte magnesium level at baseline, and change in erythrocyte magnesium and serum vitamin B6 levels at weeks 4 and 8, were analyzed. Overall, 264 subjects were randomized to treatment and had evaluable Depression Anxiety Stress Scale scores (132 in each treatment arm). At baseline, stress scores, and mean serum magnesium, erythrocyte magnesium, and serum vitamin B6 concentrations were similar between arms. Although not significant between groups, a significant increase over time in erythrocyte magnesium levels was observed in the subgroup of subjects with low baseline erythrocyte magnesium levels (<1.6 mmol/L) following treatment with magnesium and magnesium-vitamin B6 (week 4:0.21 mmol/L [95% confidence interval (CI), 0.10 to 0.31], p = 0.0003; and 0.13 mmol/L [95% CI, 0.02 to 0.23], p = 0.0233, respectively). Change from baseline in circulating vitamin B6 levels at weeks 4 and 8 in the magnesium-vitamin B6 supplemented group (314.96 nmol/L [95%CI, 294.61 to 335.31]) was significantly different (p < 0.0001) compared with the magnesium supplemented group (-0.39 nmol/L [95% CI, -20.73 to 19.94]). Magnesium alone and magnesium-vitamin B6 provided statistically significant increases in erythrocyte magnesium in subjects with low magnesium status (<1.6mmol/L). Vitamin B6 supplementation did not further increase magnesium levels.",2020,Magnesium alone and magnesium-vitamin B6 provided statistically significant increases in erythrocyte magnesium in subjects with low magnesium status (<1.6mmol/L).,"['subjects with low magnesium status (<1.6mmol/L', '264 subjects']","['Vitamin B6 supplementation', 'oral magnesium', 'magnesium', 'magnesium-vitamin B6', 'vitamin B6', 'magnesium and magnesium-vitamin B6', 'magnesium and vitamin B6', 'magnesium and vitamin B6 supplementation', 'magnesium supplementation', 'Magnesium alone and magnesium-vitamin B6']","['evaluable Depression Anxiety Stress Scale scores', 'erythrocyte magnesium levels', 'erythrocyte magnesium and serum vitamin B6 levels', 'circulating vitamin B6 levels', 'Stress level and erythrocyte magnesium level', 'stress scores, and mean serum magnesium, erythrocyte magnesium, and serum vitamin B6 concentrations', 'magnesium levels', 'erythrocyte magnesium', 'time in erythrocyte magnesium levels']","[{'cui': 'C0240291', 'cui_str': 'Mg reduced'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C4524021', 'cui_str': 'Vitamin B6 supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}]","[{'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0428584', 'cui_str': 'Serum pyridoxine measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",264.0,0.559892,Magnesium alone and magnesium-vitamin B6 provided statistically significant increases in erythrocyte magnesium in subjects with low magnesium status (<1.6mmol/L).,"[{'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Noah', 'Affiliation': 'Global Medical Nutritionals, Consumer Healthcare, Sanofi, Paris, France.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'Clinical Pharmacology Center, INSERM CIC 1405, University Hospital Clermont-Ferrand, France.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Université Clermont Auvergne, INRAE, UNH, Unité de Nutrition Humaine, Clermont-Ferrand, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Dubray', 'Affiliation': 'Clinical Pharmacology Center, INSERM CIC 1405, University Hospital Clermont-Ferrand, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hitier', 'Affiliation': 'Statistics, Consumer Healthcare, Sanofi, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dualé', 'Affiliation': 'Clinical Pharmacology Center, INSERM CIC 1405, University Hospital Clermont-Ferrand, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Pouteau', 'Affiliation': 'Global Medical Nutritionals, Consumer Healthcare, Sanofi, Paris, France.'}]",Magnesium research,['10.1684/mrh.2020.0468']
2398,33210771,Crestal bone changes around early vs. conventionally loaded implants with a multiphosphonate coated surface: a randomized pilot clinical trial.,"OBJECTIVES


To compare the marginal bone level around implants with a thin multi-phosphonate coated surface after either an early or conventional loading protocol.
MATERIAL AND METHODS


A randomized pilot clinical trial was conducted. Dental impressions were obtained after either 4 (test) or 8 weeks (control) and single crowns screwed-in 2 weeks later. Several variables were evaluated including radiographical marginal bone level (MBL), patient's level variables and those related to the restoration and surrounding tissues. These data were obtained at several time points up to a 1-year follow-up.
RESULTS


Thirty-four patients were included in the study, 18 assigned to the test group. No differences at implant placement were detected for tissue thickness, keratinized mucosa nor any other clinical or radiological variable. At the time of impressions, tissue was thinner in the test group (2.30 (0.46) vs. 2.78 (0.66) mm, test vs. control, respectively; p=0.012) so shorter abutments were used in this group. Regardless, no significant changes in marginal bone level were detected neither within group along time nor between groups. The average MBL at the 1-year follow-up was -0.15 (0.32) vs. -0.22 (0.37) (p=0.443) (test vs. control, respectively). None of the clinical or radiological variables evaluated had a determinant influence on the MBL at any visit nor group.
CONCLUSION


The use of implants with a multi-phosphonate coated surface for early loading offers successful radiographical outcomes 1 year after loading. MBL over time was not affected by taking the impressions 4 or 8 weeks after implant placement and loading them 2 weeks later.",2020,MBL over time was not affected by taking the impressions 4 or 8 weeks after implant placement and loading them 2 weeks later.,"['Thirty-four patients were included in the study, 18 assigned to the test group']",['multiphosphonate coated surface'],"['Crestal bone changes', 'average MBL', 'MBL over time', 'tissue thickness, keratinized mucosa nor any other clinical or radiological variable', 'marginal bone level', ""radiographical marginal bone level (MBL), patient's level variables and those related to the restoration and surrounding tissues""]","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}]",34.0,0.0518676,MBL over time was not affected by taking the impressions 4 or 8 weeks after implant placement and loading them 2 weeks later.,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Galindo-Moreno', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Gutierrez-Garrido', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Lopez-Chaichio', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Guerra-Lorenzo', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Roque', 'Initials': 'R', 'LastName': 'Rodriguez-Alvarez', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Padial-Molina', 'Affiliation': 'Department of Oral Surgery and Implant Dentistry, School of Dentistry, University of Granada, Granada, Spain.'}]",Clinical oral implants research,['10.1111/clr.13681']
2399,33210773,Effectiveness of physical activity prescription by primary care nurses using health assets: A randomized controlled trial.,"AIM


To evaluate the effectiveness of a 12-month multifactorial intervention by primary care nurses using health assets in increasing adherence to physical activity prescription (150 min/week) in patients with two or more cardiovascular risk factors.
BACKGROUND


Physical activity promotion is a priority and helps to decrease mortality risk due to cardiovascular diseases. However, adherence to the habitual physical activity prescription in primary healthcare settings is low.
DESIGN


Multicentre, single-blind, parallel randomized (in two different branches) clinical trial.
METHODS


In total, 263 participants from 20 primary healthcare centres in Mallorca completed the randomized controlled trial study (intervention group N = 128, control group N = 135). The intervention consisted in four visits and included a motivational interview and an individualized prescription of physical activity using health assets. Primary outcome measure was the number of participants performing at least 150 min of weekly physical activity. Secondary outcomes included physical activity level and physical fitness, Sense of Coherence, cardiovascular risk, sociodemographic data, trans-theoretical stage of change, sleep quality, and depression.
RESULTS


Adherence to the recommendation of at least 150 min of physical activity was higher in the intervention than in the control group (χ 2   = 3.951, p = .047). However, this higher adherence did not suppose higher physical activity levels because no differences between groups were found in the total physical activity performed after intervention (t=-0.915, p = .361). At the end of the intervention participants randomized to the intervention group spent more time walking than participants in the control group (t = 2.260, p = .025).
CONCLUSION


The multifactorial intervention performed by primary care nurses induced a higher adherence to the 150-min of weekly physical activity recommendation.
IMPACT


Adherence to the usual physical activity prescription in primary care is low. Physical activity prescription performed by primary care nurses and based on health assets and motivational interview can help to increase physical activity levels of patients. The main finding of the present study was that prescription using this approach was shown to be effective, leading to a higher adherence in the intervention group. This intervention is feasible in the nurse's primary healthcare setting, thus it could be implemented as the main tool when exercise is prescribed.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number: ISRCTN76069254.",2020,"The multifactorial intervention performed by primary care nurses induced a higher adherence to the 150-min of weekly physical activity recommendation.
","['263 participants from 20 primary healthcare centres in Mallorca', 'primary care nurses using health assets', 'patients with two or more cardiovascular risk factors']","['physical activity prescription', 'motivational interview and an individualized prescription of physical activity using health assets', 'multifactorial intervention', 'Physical activity promotion', 'usual physical activity prescription', 'habitual physical activity prescription']","['number of participants performing at least 150\xa0min of weekly physical activity', 'physical activity', 'physical activity level and physical fitness, Sense of Coherence, cardiovascular risk, sociodemographic data, trans-theoretical stage of change, sleep quality, and depression', 'total physical activity', 'time walking', 'physical activity levels']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454825', 'cui_str': 'Mallorca'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",263.0,0.0779457,"The multifactorial intervention performed by primary care nurses induced a higher adherence to the 150-min of weekly physical activity recommendation.
","[{'ForeName': 'Aina', 'Initials': 'A', 'LastName': 'Riera-Sampol', 'Affiliation': 'Research Group on Evidence, Lifestyles and Health, University of the Balearic Islands, Palma, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Bennasar-Veny', 'Affiliation': 'Research Group on Evidence, Lifestyles and Health, University of the Balearic Islands, Palma, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Tauler', 'Affiliation': 'Research Group on Evidence, Lifestyles and Health, University of the Balearic Islands, Palma, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Aguilo', 'Affiliation': 'Research Group on Evidence, Lifestyles and Health, University of the Balearic Islands, Palma, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14649']
2400,33210806,Massage enhances recovery following exercise-induced muscle damage in older adults.,"To examine efficacy of cold-water immersion (CWI) and massage as recovery techniques on joint position sense, balance, and fear of falling following exercise-induced muscle damage in older adults. Seventy-eight older men and women performed a single bout of strength training on the calf muscles (3 exercises with 4 sets of 10 reps with 75% of 1RM) to induce muscle damage. After the damaging exercise, participants received either a 15-min massage on calf muscles, or a CWI of the lower limb in cold water (15±1°C) for 15 min, or passive rest. Interventions were applied immediately after the exercise protocol and at 24, 48, and 72 hours post-exercise. Muscle pain, calf muscle strength, joint position sense, dynamic balance, postural sway and fear of falling were measured at each time point. Repeated application of massage after EIMD relieved muscle pain, attenuated the loss of muscle strength and joint position senses, reduce balance impairments and fear of falling in older adults (p≤0.05). However, repeated applications of CWI, despite relieving muscle pain (p≤0.05), did not attenuate the loss of muscle strength, joint position senses, balance impairments, and fear of falling. CWI had only some modest effects on muscle pain, but massage attenuated EIMD symptoms and the related impairments in muscle strength, joint position sense, balance, and postural sway in untrained older individuals. Therefore, older exercisers who plan to participate in strength training can benefit from massage for recovery from muscle damage indices and balance to decrease falling risk during the days following strength training.",2020,"However, repeated applications of CWI, despite relieving muscle pain (p≤0.05), did not attenuate the loss of muscle strength, joint position senses, balance impairments, and fear of falling.","['older adults', 'Seventy-eight older men and women performed a', 'older exercisers who plan to participate in', 'untrained older individuals']","['15-min massage on calf muscles, or a CWI of the lower limb in cold water (15±1°C) for 15 min, or passive rest', 'Massage', 'cold-water immersion (CWI) and massage', 'strength training', 'single bout of strength training on the calf muscles (3 exercises with 4 sets of 10 reps with 75% of 1RM']","['loss of muscle strength and joint position senses', 'Muscle pain, calf muscle strength, joint position sense, dynamic balance, postural sway and fear of falling', 'joint position sense, balance, and fear of falling', 'loss of muscle strength, joint position senses, balance impairments, and fear of falling', 'muscle pain', 'muscle strength, joint position sense, balance, and postural sway', 'balance impairments and fear of falling']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0241981', 'cui_str': 'Impairment of balance'}]",78.0,0.0135271,"However, repeated applications of CWI, despite relieving muscle pain (p≤0.05), did not attenuate the loss of muscle strength, joint position senses, balance impairments, and fear of falling.","[{'ForeName': 'Aynollah', 'Initials': 'A', 'LastName': 'Naderi', 'Affiliation': 'School of Sport Science, Shahrood University of Technology, Shahrood, Semnan, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Aminian-Far', 'Affiliation': 'Neuro-muscular Rehabilitation Research Center, Rehabilitation Faculty, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Gholami', 'Affiliation': 'School of Sport Science, Shahrood University of Technology, Shahrood, Semnan, Iran.'}, {'ForeName': 'Seyed Hamed', 'Initials': 'SH', 'LastName': 'Mousavi', 'Affiliation': 'University of Groningen, Medical Center Groningen, Department of Rehabilitation Medicine, Groningen, the Netherlands.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Saghari', 'Affiliation': 'University of Kharazmi, Faculty of Physical Education and Sport Sciences, Department of Sport Medicine, Tehran, Iran.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13883']
2401,33210831,"Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial.","Lack of donors hinders living donor kidney transplantation (LDKT) for African Americans. We studied the effectiveness of a transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance to activate African Americans' potential living kidney donors. African Americans (N=300) on the transplant waiting list were randomly assigned to usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance. We quantified differences in live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) after 12 months. Participants' mean age was 52 years, 56% were male, and 43% had annual household income less than $40,000. Most previously pursued LDKT. Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance. After 12 months, few (n=39, 13%) participants had a new donor activation event [35 (12%) new donor inquiries; 17 (6%) new donor evaluations; 4 (1%) LDKT]. There were no group differences in donor activation events [subdistribution hazard ratio (95% CI): 1.09 (0.51-2.30) for TALK SWI and 0.92 (0.42-2.02) for TALK SWI plus Financial Assistance compared to Usual Care, p=0.91)]. Alternative interventions to increase LDKT for African Americans on the waiting list may be needed.",2020,There were no group differences in donor activation events [subdistribution hazard ratio (95% CI): 1.09 (0.51-2.30) for TALK SWI and 0.92,"['African Americans (N=300) on the transplant waiting list', 'donors hinders living donor kidney transplantation (LDKT) for African Americans', 'African Americans', 'Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance', ""African Americans' potential living kidney donors"", ""Participants' mean age was 52 years, 56% were male, and 43% had annual household income less than $40,000""]","['usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance', 'transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance', 'Transplant social worker and donor financial assistance']","['new donor activation event', 'donor activation events', 'live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4305252', 'cui_str': 'Live donor of kidney'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",,0.0303003,There were no group differences in donor activation events [subdistribution hazard ratio (95% CI): 1.09 (0.51-2.30) for TALK SWI and 0.92,"[{'ForeName': 'L Ebony', 'Initials': 'LE', 'LastName': 'Boulware', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Sudan', 'Affiliation': 'Division of Abdominal Transplant, Duke Department of Surgery, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Strigo', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Patti L', 'Initials': 'PL', 'LastName': 'Ephraim', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Clemontina A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jane F', 'Initials': 'JF', 'LastName': 'Pendergast', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Pounds', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jennie A', 'Initials': 'JA', 'LastName': 'Riley', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Falkovic', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Aviel', 'Initials': 'A', 'LastName': 'Alkon', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, MD, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Cabacungan', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Barrett', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Dinushika', 'Initials': 'D', 'LastName': 'Mohottige', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McElroy', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Clarissa J', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16403']
2402,33210938,Four-Year Follow-Up of High versus Low Intensity Summer Treatment for Adolescents with ADHD.,"OBJECTIVE


Despite an emergence of psychosocial treatments for adolescent ADHD, their long-term effects are unknown.
METHOD


We examine four-year outcomes of a randomized controlled trial ( N =  218) comparing high-intensity (HI; 412 h, $4,373 per participant) versus low-intensity (LI; 24 h, $97 per participant) skills-based summer intervention delivered to adolescents with ADHD at two secondary school transitions (6th/9th grade). Quantitative and qualitative analyses evaluated group×time and group×grade×time effects on 4-year outcomes.
RESULTS


Relative to LI, a single dose of HI had modest but lasting effects on teen organization skills ( d = .40) and ADHD symptoms (9th grade only:  d = .27 to.31) at 4-year follow-up. There was no long-term incremental effect of HI (vs. LI) for parent-teen conflict, GPA, or parent use of contingency management. Treatment appeared most effective when delivered to older adolescents (i.e., 9th versus 6th grade), suggesting the long-term impact of ADHD treatment may increase with age. Qualitative data corroborated that the primary long-term benefit of HI (vs. LI) treatment was to organization skills; many of the remaining perceived benefits were to parent and teen psychological variables (i.e., increased self-esteem, self-awareness, parental optimism). HI offered no incremental benefit to long-term educational or clinical service utilization or costs.
CONCLUSIONS


Modest therapeutic benefits of adolescent ADHD treatment are maintained long term. However, HI treatment did not impact outcomes that could defray the intervention's high costs ($4,373) compared to LI treatment ($97).",2020,"Relative to LI, a single dose of HI had modest but lasting effects on teen organization skills ( d = .40) and ADHD symptoms (9th grade only:  ",['Adolescents with ADHD'],"['low-intensity (LI; 24\xa0h, $97 per participant) skills-based summer intervention delivered to adolescents with ADHD at two secondary school transitions']","['ADHD symptoms', 'self-esteem, self-awareness, parental optimism']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C3146223', 'cui_str': 'Awareness of self'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}]",,0.0807321,"Relative to LI, a single dose of HI had modest but lasting effects on teen organization skills ( d = .40) and ADHD symptoms (9th grade only:  ","[{'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Stefany J', 'Initials': 'SJ', 'LastName': 'Coxe', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Page', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Yeguez', 'Affiliation': 'Department of Psychology, Florida International University.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'LaCount', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Barney', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Research Institute.""}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1833734']
2403,33210944,"Correction to: Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial.",,2020,,['Patients With ST-Segment-Elevation Myocardial Infarction'],"['Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C1121991', 'cui_str': 'cangrelor'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],,0.0164508,,[],Circulation,['10.1161/CIR.0000000000000910']
2404,33210975,Corneal cross-linking versus conventional management for keratoconus: a lifetime economic model.,"AIMS


Assess the cost-effectiveness of corneal collagen cross-linking (CXL) versus no CXL for keratoconus in the United States (US).
METHODS


A discrete-event microsimulation was developed to assess the cost-effectiveness of corneal cross-linking (CXL, Photrexa + KXL combination product) versus no CXL for patients with keratoconus. The lifetime model was conducted from a US payor perspective. The source for CXL efficacy and safety data was a 12-month randomized, open-label, sham-controlled, multi-center, pivotal trial comparing CXL versus no CXL. Other inputs were sourced from the literature. The primary outcome was the incremental cost per quality-adjusted life year gained. Costs (2019 USD) and effects were discounted 3% annually. The impacts of underlying uncertainty were evaluated by scenario, univariate, and probabilistic analyses.
RESULTS


Starting at a mean baseline age of 31 years and considering a mixed population consisting of 80% slow-progressors and 20% fast-progressors, the CXL group was 25.9% less likely to undergo penetrating keratoplasty (PK) and spent 27.9 fewer years in advanced disease stages. CXL was dominant with lower total direct medical costs (-$8,677; $30,994 vs. $39,671) and more QALYs (1.88; 21.80 vs. 19.93) compared to no CXL. Considering the impact of reduced productivity loss in an exploratory scenario, CXL was associated with a lifetime cost-savings of $43,759 per patient. CXL was cost-effective within 2 years and cost-saving within 4.5 years.
LIMITATIONS


Limitations include those that are common to similar pharmacoeconomic models that rely on disparate sources for inputs and extrapolation on short-term outcomes to a long-term analytical horizon.
CONCLUSIONS


Keratoconus is a progressive and life-altering disease with substantial clinical, economic, and humanistic consequences. The economic value of cross-linking is maximized when applied earlier in the disease process and/or younger age, and extends to improved work productivity, out-of-pocket costs, and quality of life.",2020,"CXL was dominant with lower total direct medical costs (-$8,677; $30,994 vs. $39,671) and more QALYs (1.88; 21.80 vs. 19.93) compared to no CXL.",['patients with keratoconus'],"['CXL versus no CXL', 'corneal cross-linking (CXL, Photrexa\u2009+\u2009KXL combination product) versus no CXL', 'Corneal cross-linking versus conventional management', 'CXL', 'corneal collagen cross-linking (CXL) versus no CXL']","['incremental cost per quality-adjusted life year gained', 'total direct medical costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}]","[{'cui': 'C4728129', 'cui_str': 'Corneal cross linking'}, {'cui': 'C4325287', 'cui_str': 'Photrexa'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]",,0.0388652,"CXL was dominant with lower total direct medical costs (-$8,677; $30,994 vs. $39,671) and more QALYs (1.88; 21.80 vs. 19.93) compared to no CXL.","[{'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Lindstrom', 'Affiliation': 'Minnesota Eye Consultants, Bloomington, Minnesota, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Berdahl', 'Affiliation': 'Vance Thompson Vision Sioux Falls, SD, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnenfeld', 'Affiliation': 'Ophthalmic Consultants of Long Island, Long Island, NY, USA.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Thompson', 'Affiliation': 'Vance Thompson Vision Sioux Falls, SD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kratochvil', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda, MD, USA.'}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Glaukos, San Clemente, CA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Falvey', 'Affiliation': 'Glaukos, San Clemente, CA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lytle', 'Affiliation': 'Glaukos, San Clemente, CA, USA.'}, {'ForeName': 'Marc F', 'Initials': 'MF', 'LastName': 'Botteman', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda, MD, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Carter', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda, MD, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1851556']
2405,33210977,"Expression of Concern: 'The effects of probiotics on mental health and hypothalamic-pituitary-adrenal axis: A randomized, double-blind, placebo-controlled trial in petrochemical workers'.",,2020,,['petrochemical workers'],"['placebo', 'probiotics']",[],"[{'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]",[],,0.335887,,[],Nutritional neuroscience,['10.1080/1028415X.2020.1846880']
2406,33210993,Impact of green tea intake on the pharmacokinetics of celiprolol in healthy subjects.,"OBJECTIVE


To assess the effect of green tea intake on the pharmacokinetics of the β-blocker celiprolol.
MATERIALS AND METHOD


In an open-label crossover study, 3 healthy subjects were given water or a green tea beverage daily for 3 days. On day 4, each subject received a single oral dose of 200 mg celiprolol with water or green tea. Serum and urinary concentrations of celiprolol were measured for up to 24 hours.
RESULTS


Green tea intake decreased the area under the serum concentration-time curve and urinary excretion of celiprolol by 98.6 and 98.0%, respectively.
CONCLUSION


Green tea intake might have a negative impact on the clinical effectiveness of celiprolol.",2020,"RESULTS


Green tea intake decreased the area under the serum concentration-time curve and urinary excretion of celiprolol by 98.6 and 98.0%, respectively.
","['healthy\xa0subjects', '3 healthy subjects']","['green tea intake', 'celiprolol with water or green tea']","['area under the serum concentration-time curve and urinary excretion of celiprolol', 'Serum and urinary concentrations of celiprolol']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0055021', 'cui_str': 'Celiprolol'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0055021', 'cui_str': 'Celiprolol'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}]",3.0,0.0561195,"RESULTS


Green tea intake decreased the area under the serum concentration-time curve and urinary excretion of celiprolol by 98.6 and 98.0%, respectively.
","[{'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Sonoda', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ogata', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshikawa', 'Affiliation': ''}, {'ForeName': 'Keizo', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': ''}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Ikeda', 'Affiliation': ''}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Shimodozono', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203795']
2407,33210997,A UPLC-MS/MS method for simultaneous quantification of sildenafil and N-desmethyl sildenafil applied in pharmacokinetic and bioequivalence studies in a Chinese population.,"OBJECTIVE


To evaluate the pharmacokinetic parameters and bioequivalence of two sildenafil tablets (20 mg) in healthy Chinese subjects.
MATERIALS AND METHODS


A random, crossover, self-control design was used. 20 healthy subjects including males and females were randomized into two groups. A single oral dose of the trial or reference preparation was given to the two groups of subjects after an overnight fast of 10 hours. Blood samples were taken at scheduled time points. Plasma concentrations of sildenafil and N-desmethyl sildenafil were measured by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). ANOVA was used to check the difference of the mean values of the pharmacokinetic parameters between the two preparations. Bioequivalence was determined by two one-sided t-tests and 90% confidence intervals.
RESULTS


The quantitative range of sildenafil and N-desmethyl sildenafil was 2.000 - 200.0 ng/mL and 0.800 - 80.00 ng/mL, respectively. Plasma samples were stable, and there was no mutual interference between the analyte and internal standard. With the 90% confidence limit, the trial preparations AUC 0→t  and C max  fall within 80.00 - 125.00% of the reference preparation's AUC 0→t  and C max . The t max  of sildenafil and N-desmethyl sildenafil was ~ 0.9 hours and 1 hour, and the T 1/2  was 2.4 hours and 3.7 hours, respectively. The relative bioavailability of sildenafil and N-desmethyl sildenafil was 99.28 ± 3.30% and 99.20 ± 3.39%. No significant difference was found in every factor between the trial preparation and the reference preparation.
CONCLUSION


The UPLC-MS/MS method was successfully established to evaluate the pharmacokinetic parameters of sildenafil in healthy Chinese subjects. The trial preparation was bioequivalent to the reference preparation.",2020,The relative bioavailability of sildenafil and N-desmethyl sildenafil was 99.28 ± 3.30% and 99.20 ± 3.39%.,"['20 healthy subjects including males and females', 'a Chinese population', 'healthy Chinese subjects']","['sildenafil', 'sildenafil and N-desmethyl sildenafil', 'sildenafil tablets']","['relative bioavailability', 'Plasma concentrations', 'Bioequivalence']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C1665319', 'cui_str': 'Desmethylsildenafil'}, {'cui': 'C1247941', 'cui_str': 'sildenafil Oral Tablet'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",20.0,0.0698173,The relative bioavailability of sildenafil and N-desmethyl sildenafil was 99.28 ± 3.30% and 99.20 ± 3.39%.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Hualin', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Wenqun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Huiyu', 'Initials': 'H', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Bikui', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203838']
2408,33211154,Acute exercise impacts AhR and PD-1 levels of CD8 +  T-cells-Exploratory results from a randomized cross-over trial comparing endurance versus resistance exercise.,"PURPOSE


The programmed cell death protein 1 (PD-1) has become a promising target in cancer immunotherapy. PD-1 expression of CD8 +  T-cells may be increased via the exploitation of aryl hydrocarbon receptor (AhR) signaling with kynurenine (KYN) as a ligand. Since exercise affects KYN metabolism, we exploratory investigated the influence of acute exercise bouts on AhR and PD-1 levels of CD8 +  T-cells.
METHOD


In this study, 24 healthy males (age: 24.6 ± 3.9 years; weight 83.9 ± 10.5 kg; height: 182.4 ± 6.2 cm) completed a single bout of endurance (EE) and resistance exercise (RE) in a randomly assigned order on separate days. Blood samples were drawn before (t0), after (t1), and 1 h after (t2) both conditions. T-cell populations, the level of cytoplasmic AhR, and surface PD-1 were assessed by flow cytometry.
RESULTS


T-cell populations changed over time, indicated by an increase in the absolute numbers of CD3 +  lymphocytes after EE (p < .001) and RE (p = .036) and in PD-1 +  CD8 +  T-cells after EE (p = .021). Proportions of T-cell populations changed only after EE (t0-t2: p = .029; t1-t2: p = .006). The level of cytoplasmic AhR decreased immediately after exercise in both exercise conditions (EE: p = .009; RE: p = .036). The level of surface PD-1 decreased 1 h after EE (p = .005).
CONCLUSION


We analyzed the level of surface PD-1 and cytoplasmic AhR following acute physical exercise for the first time. Especially EE was observed to impact both AhR and PD-1 levels, undermining its role as the AhR-PD-1 axis modulator. These results provide new insights into the impact of exercise on AhR-signaling, which could potentially be relevant for various chronic diseases.",2020,The level of cytoplasmic AhR decreased immediately after exercise in both exercise conditions (EE: p = .009; RE: p = .036).,['24 healthy males (age: 24.6\u2009±\u20093.9\xa0years; weight 83.9\u2009±\u200910.5\xa0kg; height: 182.4\u2009±\u20096.2\xa0cm) completed a'],"['CD8 +  T-cells-Exploratory', 'single bout of endurance (EE) and resistance exercise (RE']","['level of cytoplasmic AhR, and surface PD-1', 'level of surface PD-1', 'absolute numbers of CD3 +  lymphocytes after EE', 'PD-1 expression of CD8 +  T-cells', 'level of cytoplasmic AhR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010834', 'cui_str': 'Cytoplasm'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1267816', 'cui_str': 'Lymphocyte positive for CD3 antigen'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}]",24.0,0.034554,The level of cytoplasmic AhR decreased immediately after exercise in both exercise conditions (EE: p = .009; RE: p = .036).,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schenk', 'Affiliation': 'Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walzik', 'Affiliation': 'Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Koliamitra', 'Affiliation': 'Institute for Cardiovascular Research and Sports Medicine, German Sports University Cologne, Cologne, Germany.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Schoser', 'Affiliation': 'Institute of Movement Therapy and Movement Oriented Prevention and Rehabilitation, German Sports University, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Institute for Cardiovascular Research and Sports Medicine, German Sports University Cologne, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Institute for Sport and Sport Science, TU Dortmund University, Dortmund, Germany. Philipp.zimmer@tu-dortmund.de.'}]",European journal of applied physiology,['10.1007/s00421-020-04552-w']
2409,33211204,Heat and fraud: evaluating how room temperature influences fraud likelihood.,"Despite the considerable amount of research devoted to understanding fraud, few studies have examined how the physical environment can influence the likelihood of committing fraud. One recent study found a link between room brightness and occurrence of human fraud behaviors. Therefore, the present study aims to investigate how temperature may affect fraud. Based on a power analysis using the effect size observed in a pilot study, we recruited 105 participants and randomly divided them into three temperature groups (warm, medium, and cool). We then counted fraud behaviors in each group and tested for potential significant differences with a Kruskal-Wallis test. Additionally, we used a correlation analysis to determine whether the perceived temperature affected fraud. As a result, regardless of participants' subjective sensory experience or their physical environment, we did not find that temperature-related factors influence the incidence of fraud. We discussed the potential reason for the results and suggested directions for future research.",2020,"As a result, regardless of participants' subjective sensory experience or their physical environment, we did not find that temperature-related factors influence the incidence of fraud.",['105 participants'],[],[],"[{'cui': 'C4319547', 'cui_str': '105'}]",[],[],105.0,0.0221084,"As a result, regardless of participants' subjective sensory experience or their physical environment, we did not find that temperature-related factors influence the incidence of fraud.","[{'ForeName': 'Huanxu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan. ryuukansyo@gmail.com.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Faculty of Arts and Science, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan. yamadayuk@gmail.com.'}]",Cognitive research: principles and implications,['10.1186/s41235-020-00261-2']
2410,33211212,Efficacy of once-weekly teriparatide in patients with glucocorticoid-induced osteoporosis: the TOWER-GO study.,"INTRODUCTION


Bisphosphonates are the standard treatment for glucocorticoid-induced osteoporosis (GIOP) with teriparatide being another option. While daily teriparatide has been shown to be effective in increasing bone mineral density (BMD), the efficacy of once-weekly teriparatide (56.5 µg) has not yet been evaluated. The TOWER-GO study, a 72-week, multicenter, open-label, randomized controlled trial, was conducted in patients with GIOP to compare the effects of once-weekly teriparatide and once-weekly alendronate 35 mg on BMD.
MATERIALS AND METHODS


Patients (N = 180) with GIOP for whom drug treatment was indicated according to the 2004 guidelines in Japan were randomized to receive once-weekly teriparatide (n = 89) or once-weekly alendronate (n = 91). The primary endpoint was the non-inferiority of percentage change in lumbar spine BMD at final follow-up. The secondary endpoints were the percentage change in BMD from baseline, incidence of bone fractures, and changes in bone turnover markers.
RESULTS


While the non-inferiority of teriparatide to alendronate was not confirmed, BMD increased significantly from baseline with teriparatide and alendronate by 5.09% and 4.04%, respectively (both p < 0.05), at 72 weeks. The incidence of vertebral and non-vertebral fractures was similar in both groups. Bone formation markers increased in the teriparatide group and decreased in the alendronate group.
CONCLUSIONS


The non-inferiority of once-weekly teriparatide versus once-weekly alendronate in BMD change at 72 weeks was not shown, but the increase in bone formation markers over time and the increase of BMD in GIOP patients treated with once-weekly teriparatide were confirmed.",2020,"RESULTS


While the non-inferiority of teriparatide to alendronate was not confirmed, BMD increased significantly from baseline with teriparatide and alendronate by 5.09% and 4.04%, respectively (both p < 0.05), at 72 weeks.","['patients with GIOP', 'Patients (N\u2009=\u2009180) with GIOP for whom drug treatment was indicated according to the 2004 guidelines in Japan', 'patients with glucocorticoid-induced osteoporosis']","['teriparatide (n\u2009=\u200989) or once-weekly alendronate', 'teriparatide and once-weekly alendronate 35\xa0mg on BMD', 'alendronate', 'teriparatide and alendronate', 'teriparatide']","['Bone formation markers', 'percentage change in BMD from baseline, incidence of bone fractures, and changes in bone turnover markers', 'bone mineral density (BMD', 'incidence of vertebral and non-vertebral fractures', 'non-inferiority of percentage change in lumbar spine BMD', 'BMD', 'bone formation markers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",,0.117418,"RESULTS


While the non-inferiority of teriparatide to alendronate was not confirmed, BMD increased significantly from baseline with teriparatide and alendronate by 5.09% and 4.04%, respectively (both p < 0.05), at 72 weeks.","[{'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Tanaka', 'Affiliation': 'Nagoya Rheumatology Clinic, Initiative for Rheumatology and Osteoporosis, Nagoya, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Soen Orthopedics, Osteoporosis, and Rheumatology Clinic, Kobe, Japan.'}, {'ForeName': 'Hisaji', 'Initials': 'H', 'LastName': 'Oshima', 'Affiliation': 'Graduate School of Nursing, Tokyo Healthcare University, 2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8558, Japan. h-oshima@thcu.ac.jp.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01171-5']
2411,33211251,Comparison of the Conox (qCON) and Sedline (PSI) depth of anaesthesia indices to predict the hypnotic effect during desflurane general anaesthesia with ketamine.,"Comparison of two depth of anesthesia indices, qCON (Conox) and PSI (Sedline), during desflurane sedation and their sensitivity to random ketamine boluses in patients undergoing routine surgery. The performance of desflurane and ketamine on both indices was analyzed for 11 patients, and the ketamine sensitivity was compared with another group of 11 patients under sevoflurane and propofol.The MOAA/S was used to determine sedation level and pain. Different boluses of ketamine ranging from 10 to 30 mg where randomly administered in both groups and the effect on the indexes were measured after 4 min.The indices were recorded during the whole surgery, and their correlations with the desflurane concentration and the discrimination between awake and anesthetized states were evaluated with the prediction probability statistic (Pk). The Pk values, mean (se), discriminating between awake and anesthetized states were 0.974(0.016) for the qCON and 0.962(0.0123) for the PSI, while the 1-Pk statistic for the qCON and the PSI with respect to the desflurane concentration were 0.927(0.016) and 0.918(0.018), respectively, with no statistically significant differences.The agreement between both depth of hypnosis parameters was assessed under the Bland-Altman plot and the Spearman correlation, r s  = 0.57(p < 0.001).During the sevoflurane-propofol anesthesia, which served as a control group, both indices experienced a similar behavior with a no significant change of their median values after ketamine. However, during desflurane anesthesia the qCON index did not change significantly after ketamine administration, qCON (before = 33 (4), after = 30 (17); Wilcoxon, p = 0.89), while the PSI experienced a significant increase, PSI (before = 31(6), after = 39(16) Wilcoxon, p = 0.013).This study shows that qCON and PSI have similar performance under desflurane with good discrimination between the awake and anesthetized states. While both indices exhibited similar behavior under ketamine boluses under a sevoflurane-propofol anesthesia, the qCON index had a better performance under ketamine during desflurane anesthesia.",2020,"Wilcoxon, p = 0.013).This study shows that qCON and PSI have similar performance under desflurane with good discrimination between the awake and anesthetized states.","['patients undergoing routine surgery', '11 patients, and the ketamine sensitivity was compared with another group of 11 patients under']","['qCON (Conox) and PSI (Sedline', 'ketamine', 'sevoflurane and propofol', 'Conox (qCON) and Sedline (PSI) depth', 'desflurane and ketamine', 'sevoflurane-propofol anesthesia']","['qCON index', 'desflurane concentration and the discrimination between awake and anesthetized states', 'sedation level and pain', 'prediction probability statistic (Pk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}]",,0.0354391,"Wilcoxon, p = 0.013).This study shows that qCON and PSI have similar performance under desflurane with good discrimination between the awake and anesthetized states.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Christenson', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Vazquez', 'Affiliation': 'Quantium Medical, Mataro, Barcelona, Spain. pmvazquez@dpz.eu.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Breidenstein', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Borzoo', 'Initials': 'B', 'LastName': 'Farhang', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Mathews', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Melia', 'Affiliation': 'Quantium Medical, Mataro, Barcelona, Spain.'}, {'ForeName': 'Erik Weber', 'Initials': 'EW', 'LastName': 'Jensen', 'Affiliation': 'Quantium Medical, Mataro, Barcelona, Spain.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Mathews', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00619-3']
2412,33211279,"Comments on ""Acupoint Catgut Embedding Alleviates Insomnia in Different Chinese Medicine Syndrome Types: A Randomized Controlled Trial"".",,2020,,['Different Chinese Medicine Syndrome Types'],['Acupoint Catgut Embedding Alleviates Insomnia'],[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0007420', 'cui_str': 'Catgut'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",[],,0.161671,,"[{'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. icyf1968@163.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3273-6']
2413,33211386,Performance of the Wingman catheter in peripheral artery chronic total occlusions: Short-term results from the international Wing-It trial.,"OBJECTIVES


To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.
BACKGROUND


CTO crossing remains a challenge during peripheral artery interventions.
METHODS


In this prospective, international, single-arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30-day follow-up period and compared to a performance goal of 13.0%.
RESULTS


A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow-up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle-brachial index increased from 1% to 51%.
CONCLUSIONS


Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.",2020,Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%).,"['Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14', 'patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a', '85 patients', 'peripheral artery chronic total occlusions']","['peripheral artery chronic total occlusion (CTO) crossing catheter', 'Wingman catheter', 'crossing catheter (Wingman, Reflow Medical']","['safety and effectiveness', 'CTO crossing success', 'met¾CTO crossing success', 'ankle-brachial index', 'safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0447106', 'cui_str': 'Superficial femoral artery'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0441807', 'cui_str': 'Grade C'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]",85.0,0.0788505,Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%).,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Laird', 'Affiliation': 'Adventist Heart and Vascular Institute, Adventist St. Helena Hospital, St. Helena, California.'}, {'ForeName': 'S Jay', 'Initials': 'SJ', 'LastName': 'Mathews', 'Affiliation': 'Bradenton Cardiology Center, Bradenton, Florida.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Soukas', 'Affiliation': 'Lifespan Cardiovascular Institute, The Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29366']
2414,33206567,Ride hailing app use and drunk/drugged driving among young adult nightclub patrons.,"OBJECTIVE


Nightclub patrons who consume alcohol and drugs in these venues would appear to be an important population to target with on-demand ride hailing app (RHA) services to reduce drunk/drugged driving (DUI). The present study is an exploratory examination of RHA use to avoid DUI behavior, as well as the perceived barriers and benefits of such RHA use, among young adult nightclub patrons in Miami who use drugs.
METHODS


Completers of a 2011-2015 randomized controlled trial of brief interventions to reduce health risk behaviors among young adult nightclub patrons were recruited to participate in a single self-administered computer-assisted interview about health risks, driving behaviors, and RHA perceptions and use. Recruitment (N = 123) began in June 2016 and ended in July 2017. Bivariable logistic regression and ANOVA models examined group differences between: (a) those who had used an RHA to avoid DUI vs. not; and (b) those who used RHAs as their primary mode of transportation to nightclubs vs. not.
RESULTS


About half were female (52.8%); median age was 29; 59.4% Hispanic, 31.7% Black, 8.1% white, 0.8% other race/ethnicity. Recent alcohol and marijuana use were almost universally endorsed, and more than half reported recent use/misuse of cocaine (72.4%), MDMA (63.4%), and prescription benzodiazepines (62.6%) and opioids (56.9%). More than 80% reported driving under the influence of alcohol and/or drugs in the past 12 months, and 17.1% experienced a DUI arrest in the prior two years. Almost two-thirds (65.9%) of participants had used an on-demand RHA to avoid DUI, but self-driving or riding in another's car were the most common (76.4%) primary modes of transportation to clubs. RHAs were the primary mode of travel to clubs for 21 (17.1%) respondents. Participants whose friends strongly disapproved of DUI were more than twice as likely to have used RHAs for this reason compared to those who had not done so. Those reporting RHA use to avoid DUI were less likely than others to have driven under the influence in the past 12 months and were somewhat more likely to endorse DUI-related risks. Those who used alternate modes of transportation were more likely than those who used RHAs as their primary mode of transportation to clubs to endorse the expense of RHAs and the lack of RHA drivers near their favorite clubs as barriers to RHA use to travel to nightclubs.
CONCLUSIONS


This novel study among a high-risk population points to the potential for on-demand RHAs to reduce DUI behaviors and arrests among young adult nightclub patrons who consume alcohol and/or drugs in the context of the club experience. Our findings point to key educational, peer support, and structural targets for intervention to increase the use of RHAs among this population, specifically, club-based incentives for increasing RHA availability and affordability. Research is needed to fully elucidate the findings of this exploratory study, including potential differences in intervention approaches depending on the location-specific public transportation options.",2020,Those reporting RHA use to avoid DUI were less likely than others to have driven under the influence in the past 12 months and were somewhat more likely to endorse DUI-related risks.,"['young adult nightclub patrons in Miami who use drugs', 'young adult nightclub patrons who consume alcohol and/or drugs in the context of the club experience', 'young adult nightclub patrons', 'Completers of a 2011-2015 randomized controlled trial of', 'About half were female (52.8%); median age was 29; 59.4% Hispanic, 31.7% Black, 8.1% white, 0.8% other race/ethnicity']","['brief interventions', 'cocaine']","['DUI arrest', 'health risk behaviors']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0442567', 'cui_str': 'Nightclub'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}]",,0.0211869,Those reporting RHA use to avoid DUI were less likely than others to have driven under the influence in the past 12 months and were somewhat more likely to endorse DUI-related risks.,"[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Kurtz', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, Miami, Florida.'}, {'ForeName': 'Mance E', 'Initials': 'ME', 'LastName': 'Buttram', 'Affiliation': 'Center for Applied Research on Substance Use and Health Disparities, Nova Southeastern University, Miami, Florida.'}]",Traffic injury prevention,['10.1080/15389588.2020.1839060']
2415,33206586,Efficacy of a Sexual Abuse Prevention Program with Children on an Indian Reservation.,"American Indian youth experience high rates of child sexual abuse (CSA). To date, however, we are aware of no programs that have assessed outcomes associated with an evidence-based CSA prevention program among American Indian children. The purpose of the proposed study was to assess the preliminary acceptability and efficacy of  IMpower , a 12-hour curriculum that teaches children how to identify their anatomy, recognize risk, say ""no,"" and tell others if they are being hurt. Using a non-randomized, single-arm pilot trial methodology (N = 48 4th and 5th graders), we found that some domains of children's knowledge of CSA as well as their efficacy to resist an attack increased from pre- to posttest. Moreover, 83% of children reported that they liked IMpower, and 96% of children reported that IMpower helped keep them safe. These data provide preliminary evidence that IMpower is an acceptable and effective CSA prevention initiative that requires further evaluation with American Indian children.",2020,These data provide preliminary evidence that IMpower is an acceptable and effective CSA prevention initiative that requires further evaluation with American Indian children.,"['American Indian children', 'American Indian youth experience high rates of child sexual abuse (CSA', 'Children on an Indian Reservation']",['Sexual Abuse Prevention Program'],[],"[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}]","[{'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0260695,These data provide preliminary evidence that IMpower is an acceptable and effective CSA prevention initiative that requires further evaluation with American Indian children.,"[{'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Nebraska Research on Children, Youth, Families, and Schools, University of Nebraska , Lincoln, NE, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Siller', 'Affiliation': 'Nebraska Research on Children, Youth, Families, and Schools, University of Nebraska , Lincoln, NE, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Leader Charge', 'Affiliation': 'Rosebud Sioux Tribe , USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Bordeaux', 'Affiliation': 'Rosebud Sioux Tribe , USA.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Leader Charge', 'Affiliation': 'Rosebud Sioux Tribe , USA.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Herrington', 'Affiliation': 'Oglala Sioux Tribe , USA.'}]",Journal of child sexual abuse,['10.1080/10538712.2020.1847229']
2416,33206624,"An Intervention to Enhance Social, Emotional and Identity Learning for Very Young Adolescents: Protocol of a Pragmatic Randomized Controlled Trial to Support Gender Equality.","BACKGROUND


The onset of puberty is a pivotal period of human development that is associated with significant changes in cognitive, social, emotional, psychological and behavioral processes that shape identity formation. Very early adolescence provides a critical opportunity to shape identity formation around gender norms, attitudes and beliefs before inequitable gender norms are amplified during and after puberty.
OBJECTIVE


The aim of the Discover Learning Project is to integrate strategic insights from developmental science to promote positive transformation in social, emotional and gender identity learning among 10-11-year-olds in Tanzania. Through a pragmatic randomized controlled trial (RCT), the intervention scaffolds the development of critical social emotional mindsets and skills (curiosity, generosity, persistence, purpose, growth mindset and teamwork) delivered by conducting 18 after-school, technology driven, experiential learning sessions in small, mixed gender groups.
METHODS


The Discover Learning Intervention is a three-arm RCT that will be delivered to 579 participants selected from four public primary schools in Temeke District, Dar es Salaam. Randomization will be done at the individual level into three treatment groups receiving incremental intervention components. The treatment components range from watching Discover Learning content curated into child-friendly videos, facilitated discussions and a parent-child workbook, to be implemented over two phases, each six-weeks long. A baseline survey will be administered to participants and their parents prior to the intervention. The process will be observed systematically, and data collected using surveys, in-depth interviews, observations and focus group discussions with adolescents, parents, teachers and facilitators conducted prior, during and after each implementation phase.
RESULTS


This study builds on formative and pilot studies conducted with the target population to inform the design of the intervention. The results will generate new evidence that will inform strategies for achieving scale in Tanzania and provide insights for replication of similar programs that are invested in gender transformative interventions in peri-urban, low-resource settings.
CONCLUSIONS


The Discover Learning Intervention makes an important contribution to the field of adolescent developmental science by designing an intervention for very young adolescents in a low-resource setting.
CLINICALTRIAL


This trial was retrospectively registered with ClinicalTrials.gov NCT0445807; https://clinicaltrials.gov/ct2/show/NCT04458077.",2020,"Through a pragmatic randomized controlled trial (RCT), the intervention scaffolds the development of critical social emotional mindsets and skills (curiosity, generosity, persistence, purpose, growth mindset and teamwork) delivered by conducting 18 after-school, technology driven, experiential learning sessions in small, mixed gender groups.
","['10-11-year-olds in Tanzania', '579 participants selected from four public primary schools in Temeke District, Dar es Salaam', 'Very Young Adolescents']",['Discover Learning Intervention'],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],579.0,0.108234,"Through a pragmatic randomized controlled trial (RCT), the intervention scaffolds the development of critical social emotional mindsets and skills (curiosity, generosity, persistence, purpose, growth mindset and teamwork) delivered by conducting 18 after-school, technology driven, experiential learning sessions in small, mixed gender groups.
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Cherewick', 'Affiliation': 'Department of Health Sciences, California State University East Bay, 25800 Carlos Bee Blvd, Hayward, US.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lebu', 'Affiliation': 'Institute of Human Development, University of California Berkeley, Berkeley, US.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Institute of Human Development, University of California Berkeley, Berkeley, US.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Dahl', 'Affiliation': 'Institute of Human Development, University of California Berkeley, Berkeley, US.'}]",JMIR research protocols,['10.2196/23071']
2417,33206626,Effect of Soft Silicone Foam Dressings on Intraoperatively Acquired Pressure Injuries: A Randomized Study in Patients Undergoing Spinal Surgery.,"The use of prophylactic dressings to help prevent intraoperatively acquired pressure injuries (IAPIs) merits further study.
PURPOSE


To examine how the use of a soft silicone foam dressing affects the development of IAPIs in patients undergoing spinal surgery to obtain baseline data supporting evidence-based nursing care.
METHODS


Using a self-controlled study design, 64 patients requiring thoracic or lumbar surgery on a Wilson frame at a hospital in Seoul, South Korea, were recruited between February 12 and September 1, 2018; 50 patients were eligible. Basic demographic, health, and surgical data were obtained. Before surgery, the left or right side chest and iliac crest areas were randomly assigned to be covered with a soft silicone foam dressing. The areas were assessed at 2 time points: immediately after and 30 minutes after surgery. If an IAPI was present at 30 minutes after surgery, all sites were reevaluated after 7 days.
RESULTS


The majority of participants were male (26 participants, 52%). Average patient age was 62.54 (± 13.83) years, with a body mass index of 24.32 (± 4.23) kg/m2. Average length of surgery was 218.4 (± 137) minutes. Immediately after surgery, 26 IAPIs were observed and there was a significant difference between dressed and non-dressed chest areas for the number of IAPIs (4% vs. 28%; P = .002). After 30 minutes, the total number of IAPIs was 20 and the difference between IAPIs in the iliac crest area was significant between dressed and non-dressed areas (0% vs. 14%; P = .012). After 1 week, there were no chest or iliac crest IAPIs in the areas that had been covered by a dressing; however, 8 chest (61.5%) and 4 iliac crest (30.8%) area IAPIs remained when no dressing had been applied. The majority of IAPIs were stage 1 at all assessment times. After 1 week, 1 IAPI had evolved into a stage 3 injury.
CONCLUSIONS


The results of this study show that many stage 1 IAPIs do resolve over time and that use of soft silicone foam dressings during spinal surgery can significantly reduce IAPI rates. Additional longitudinal studies are needed to help guide postoperative skin assessment intervals and increase the understanding about the evolution of stage 1 IAPIs.",2020,"Immediately after surgery, 26 IAPIs were observed and there was a significant difference between dressed and non-dressed chest areas for the number of IAPIs (4% vs. 28%; P = .002).","['Patients Undergoing Spinal Surgery', 'Before surgery, the left or right side chest and iliac crest areas', 'Intraoperatively Acquired Pressure Injuries', 'patients undergoing spinal surgery to obtain baseline data supporting evidence-based nursing care', 'Average patient age was 62.54 (± 13.83', '64 patients requiring thoracic or lumbar surgery on a Wilson frame at a hospital in Seoul, South Korea, were recruited between February 12 and September 1, 2018; 50 patients were eligible']","['prophylactic dressings', 'soft silicone foam dressing', 'Soft Silicone Foam Dressings']","['chest or iliac crest IAPIs', 'iliac crest area', 'total number of IAPIs', 'IAPI rates', '4 iliac crest']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2350328', 'cui_str': 'Nursing, Evidence-Based'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",50.0,0.0351592,"Immediately after surgery, 26 IAPIs were observed and there was a significant difference between dressed and non-dressed chest areas for the number of IAPIs (4% vs. 28%; P = .002).","[{'ForeName': 'Tae-Yeong', 'Initials': 'TY', 'LastName': 'Yang', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'College of Nursing Science, East-West Nursing Research Institute, Kyung Hee University, Seoul, Repulic of Korea.'}]",Wound management & prevention,[]
2418,33211592,Acute inorganic nitrate supplementation and the hypoxic ventilatory response in patients with obstructive sleep apnea.,"Patients with obstructive sleep apnea (OSA) have increased cardiovascular disease risk largely attributable to hypertension. Heightened peripheral chemoreflex sensitivity (i.e., exaggerated responsiveness to hypoxia) facilitates hypertension in these patients. Nitric oxide blunts the peripheral chemoreflex and patients with OSA have reduced nitric oxide bioavailability. We therefore investigated the dose-dependent effects of acute inorganic nitrate supplementation (beetroot juice), an exogenous nitric oxide source, on blood pressure and cardiopulmonary responses to hypoxia in patients with OSA using a randomized, double-blind, placebo-controlled crossover design. Fourteen patients with OSA (53±10years, 29.2±5.8kg/m 2 , apnea-hypopnea index=17.8±8.1, 43%F) completed three visits. Resting brachial blood pressure, as well as cardiopulmonary responses to inspiratory hypoxia, were measured before, and two hours after, acute inorganic nitrate supplementation (~0.10mmol [placebo], 4.03mmol [low-dose], and 8.06mmol [high-dose]). Placebo did not increase either plasma [nitrate] (30±52 to 52±23μM, P=0.26) or [nitrite] (266±153 to 277±164nM, P=0.21); however, both increased following low-(29±17 to 175±42μM, 220±137 to 514±352nM) and high-doses (26±11 to 292±90μM, 248±155 to 738±427nM, respectively, P<0.01 for all). Following placebo, systolic blood pressure increased (120±9 to128±10mmHg, P<0.05) whereas no changes were observed following low-(121±11 to 123±8mmHg, P=0.19) or high-dose (124±13 to 124±9mmHg, P=0.96). The peak ventilatory response to hypoxia increased following placebo (3.1±1.2 to 4.4±2.6L/min, P<0.01) but not low-(4.4±2.4 to 5.4±3.4L/min, P=0.11) or high-doses (4.3±2.3 to 4.8±2.7L/min, P=0.42). Inorganic nitrate did not change the heart rate responses to hypoxia (beverage-by-time P=0.64). Acute inorganic nitrate supplementation appears to blunt an early-morning rise in systolic blood pressure potentially through suppression of peripheral chemoreflex sensitivity in patients with OSA.",2020,"Following placebo, systolic blood pressure increased (120±9 to128±10mmHg, P<0.05) whereas no changes were observed following low-(121±11 to 123±8mmHg, P=0.19) or high-dose (124±13 to 124±9mmHg, P=0.96).","['Patients with obstructive sleep apnea (OSA', 'patients with OSA', 'Fourteen patients with OSA (53±10years, 29.2±5.8kg/m 2 , apnea-hypopnea index=17.8±8.1, 43%F) completed three visits', 'patients with obstructive sleep apnea']","['placebo', 'Nitric oxide', 'Acute inorganic nitrate supplementation', 'acute inorganic nitrate supplementation (~0.10mmol [placebo', 'Placebo', 'acute inorganic nitrate supplementation (beetroot juice', 'Inorganic nitrate']","['Resting brachial blood pressure', 'Heightened peripheral chemoreflex sensitivity', 'systolic blood pressure', 'peak ventilatory response to hypoxia', 'heart rate responses', 'blood pressure and cardiopulmonary responses to hypoxia', 'plasma [nitrate', 'hypoxic ventilatory response', 'nitric oxide bioavailability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",14.0,0.095579,"Following placebo, systolic blood pressure increased (120±9 to128±10mmHg, P<0.05) whereas no changes were observed following low-(121±11 to 123±8mmHg, P=0.19) or high-dose (124±13 to 124±9mmHg, P=0.96).","[{'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Bock', 'Affiliation': 'Department of Physiology Therapy & Rehabilitation Science, University of Iowa, United States.'}, {'ForeName': 'Brady E', 'Initials': 'BE', 'LastName': 'Hanson', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, United States.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Asama', 'Affiliation': 'Department of Physicals Therapy & Rehabilitation Science, University of Iowa, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Feider', 'Affiliation': 'Department of Anesthesia, University of Iowa, United States.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hanada', 'Affiliation': 'Department of Anesthesia, University of Iowa, United States.'}, {'ForeName': 'Aric W', 'Initials': 'AW', 'LastName': 'Aldrich', 'Affiliation': 'Department of Anesthesia, University of Iowa, United States.'}, {'ForeName': 'Mark Eric', 'Initials': 'ME', 'LastName': 'Dyken', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals, United States.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Casey', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Iowa, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00696.2020']
2419,33206670,"Effects of small-sided recreational team handball training on mechanical muscle function, body composition and bone mineralization in untrained young adults-A randomized controlled trial.","Prolonged physical inactivity in young adults may lead to deficiencies in musculoskeletal fitness, and thus a need exists to develop physical activity and exercise programmes that are effective of increasing musculoskeletal fitness. The aim of this study, therefore, was to investigate the effects of small-sided team handball training on lower limb muscle strength, postural balance and body composition in young adults. Twenty-six men and twenty-eight women were stratified for peak oxygen uptake (VO2peak) and body fat percentage and randomly allocated to either 12 wks of small-sided recreational team handball training (THG: 14 men and 14 women, age 24.1±2.6 yrs (mean±SD), VO2peak 39.8±5.9 ml/kg/min and body fat percentage 32.7±8.7%) or serving as non-exercising controls (CON: 12 men and 14 women, age 24.8±3.1 yrs, VO2peak 39.7±5.0 ml/kg/min, body fat percentage 31.7±9.7%). THG trained on average 1.8 times/week for 12 wks. At 0 and 12 wks, lower limb muscle strength, rate of force development (RFD), vertical jump height and power, postural balance, body composition and muscle biopsies were assessed. No training effects were observed for maximal isokinetic or isometric knee extensor strength, maximal vertical jump height or take-off power, fibre type distribution or capillarization. Late phase (RFD) increased (+7.4%, p<0.05) and postural sway excursion length was improved after training (-9%, p<0.05) in THG with no difference from CON (p>0.05). Further, THG demonstrated a decrease in body fat percentage (-3.7%) accompanied by increases in whole-body fat free mass (FFM) (+2.2%), leg FFM (+2.5%), total bone mineral content (BMC) (+1.1%), leg BMC (+1.2%), total hip bone mineral density (+1.6%) and hip T-score (+50%) which differed from CON (all p<0.05). In conclusion, recreational small-sided team handball training appears to effectively improve rapid force capacity, postural balance, lean and fat body mass and bone health in previously untrained young adults. The study was registered at ClinicalTrials.gov (NCT04247724). ClinicalTrials.gov ID number: NCT04247724.",2020,"No training effects were observed for maximal isokinetic or isometric knee extensor strength, maximal vertical jump height or take-off power, fibre type distribution or capillarization.","['untrained young adults', 'young adults', 'Twenty-six men and twenty-eight women were stratified for peak oxygen uptake (VO2peak) and body fat percentage and randomly allocated to either 12 wks of small-sided recreational team handball training (THG: 14 men and 14 women, age 24.1±2.6 yrs (mean±SD', 'previously untrained young adults']","['THG', 'VO2peak 39.8±5.9 ml/kg/min and body fat percentage 32.7±8.7%) or serving as non-exercising controls', 'small-sided recreational team handball training', 'small-sided team handball training']","['mechanical muscle function, body composition and bone mineralization', 'body fat percentage', 'leg FFM', 'lower limb muscle strength, postural balance and body composition', 'total bone mineral content (BMC', 'total hip bone mineral density', 'postural sway excursion length', 'rapid force capacity, postural balance, lean and fat body mass and bone health', 'whole-body fat free mass (FFM', 'hip T-score', 'leg BMC', 'maximal isokinetic or isometric knee extensor strength, maximal vertical jump height or take-off power, fibre type distribution or capillarization', 'Late phase (RFD', 'lower limb muscle strength, rate of force development (RFD), vertical jump height and power, postural balance, body composition and muscle biopsies']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039902', 'cui_str': 'Thioguanine'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039902', 'cui_str': 'Thioguanine'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0023217', 'cui_str': 'Bones of Leg'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}]",26.0,0.0332631,"No training effects were observed for maximal isokinetic or isometric knee extensor strength, maximal vertical jump height or take-off power, fibre type distribution or capillarization.","[{'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Fristrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jesper L', 'Initials': 'JL', 'LastName': 'Andersen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Hornstrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik T', 'Initials': 'FT', 'LastName': 'Løwenstein', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel A', 'Initials': 'MA', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørn W', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Susana C A', 'Initials': 'SCA', 'LastName': 'Póvoas', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Aagaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Muscle Physiology and Biomechanics, University of Southern Denmark, Odense, Denmark.'}]",PloS one,['10.1371/journal.pone.0241359']
2420,33206751,Analysis of the Clinical Effects of the Combination of Mycophenolate Mofetil with Either Tacrolimus or Cyclophosphamide.,"OBJECTIVES


Here, we aimed to compare the clinical effects of mycophenolate mofetil combined with either tacrolimus or with cyclophosphamide on lupus nephritis (LN) and to analyze their influence on the expression of cystatin C and on transforming growth factor-1 (TGF-β1).
METHODS


A total of 234 patients were randomly divided into two groups: group A, for mycophenolate mofetil combined with tacrolimus (n=117) and group B, for mycophenolate mofetil combined with cyclophosphamide (n=117). The enzyme-linked immunosorbent assay was adopted to detect the expression levels of serum TGF-β1 and cystatin C before and after treatment.
RESULTS


The total effectiveness rate in group A was much higher than that in group B. The times of effectiveness and effect validity in group A were much lower than those in group B. The expression levels of serum TGF-β1 and cystatin C decreased slightly after treatment in the two groups, and those of group A were much lower than those of group B.
CONCLUSIONS


The combination of mycophenolate mofetil and tacrolimus showed better clinical efficacy on LN and was safer than that of mycophenolate mofetil and cyclophosphamide. Moreover, the drug combination of mycophenolate mofetil and tacrolimus greatly reduced the expression levels of serum TGF-β1 and cystatin C.",2020,"The expression levels of serum TGF-β1 and cystatin C decreased slightly after treatment in the two groups, and those of group A were much lower than those of group B.
CONCLUSIONS


",['234 patients'],"['cyclophosphamide', 'mycophenolate mofetil combined with tacrolimus', 'mycophenolate mofetil combined with cyclophosphamide', 'mycophenolate mofetil and cyclophosphamide', 'Mycophenolate Mofetil with Either Tacrolimus or Cyclophosphamide', 'mycophenolate mofetil combined with either tacrolimus', 'mycophenolate mofetil and tacrolimus']","['total effectiveness rate', 'lupus nephritis (LN', 'times of effectiveness and effect validity', 'expression levels of serum TGF-β1 and cystatin C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}]",234.0,0.014243,"The expression levels of serum TGF-β1 and cystatin C decreased slightly after treatment in the two groups, and those of group A were much lower than those of group B.
CONCLUSIONS


","[{'ForeName': 'Xuebing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Lanling County People's Hospital, Linyi, Shandong, China.""}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Nephrology, Lanling County People's Hospital, Linyi, Shandong, China.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Nephrology, Lanling County People's Hospital, Linyi, Shandong, China.""}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1820']
2421,33206752,Evaluation of pH and residual gastric volume after colon preparation with mannitol: prospective randomized study comparing procedure performed after 3 hours versus 6 hours.,"OBJECTIVES


Our goal was to compare the hydrogen potential (pH) and residual gastric volume (RGV) of patients undergoing colonoscopy after 3 and 6 hours of colon preparation with mannitol.
METHODS


We described a prospective randomized trial with a 50:50 allocation rate of two distinct times of colonoscopy after colon preparation with 10% mannitol. We included outpatients aged over 18 years, with no history of gastric surgeries and an American Society of Anesthesiologists (ASA)-rated anesthetic risk below III. Colonoscopy was performed after upper digestive endoscopy at two different times: 3 versus 6-hour after mannitol ingestion. During upper gastrointestinal endoscopy, we measured RGV and evaluated pH with a digital pH meter. Clinical trials.gov: 71123317.9.3001.0065.
RESULTS


We randomized a total of 100 participants to the 3 and 6-hour groups, with the patients in the 6-hour group being younger and presenting a higher body mass index (BMI). The intervention did not result in any statistically significant differences between the two groups, neither for the RGV (p=0.98) or the pH (p=0.732). However, the subgroup of patients with diabetes mellitus showed statistically significant higher RGV values in the 3-hour group.
CONCLUSION


There was no difference between RGV and pH values at 3 versus 6-hour after bowel preparation with mannitol, except for RGV in diabetic patients at 3 hours. As prolonged fasting protocols may result in adverse events such as dehydration and electrolyte imbalance, we can infer that colonic preparation with mannitol in shorter fasting periods, such as 3 hours, can be adopted safely and routinely.",2020,"There was no difference between RGV and pH values at 3 versus 6-hour after bowel preparation with mannitol, except for RGV in diabetic patients at 3 hours.","['patients undergoing colonoscopy after 3 and 6 hours of colon preparation with mannitol', 'outpatients aged over 18 years, with no history of gastric surgeries and an American Society of Anesthesiologists (ASA)-rated anesthetic risk below III', '100 participants to the 3 and 6-hour groups, with the patients in the 6-hour group being younger and presenting a higher body mass index (BMI']","['mannitol', 'colonoscopy after colon preparation with 10% mannitol']","['hydrogen potential (pH) and residual gastric volume (RGV', 'RGV values', 'RGV and pH values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0192398', 'cui_str': 'Operation on stomach'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C4544425', 'cui_str': 'At risk of complication of anesthesia'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}]","[{'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",100.0,0.0961476,"There was no difference between RGV and pH values at 3 versus 6-hour after bowel preparation with mannitol, except for RGV in diabetic patients at 3 hours.","[{'ForeName': 'Renzo Feitosa', 'Initials': 'RF', 'LastName': 'Ruiz', 'Affiliation': 'Hospital Alemao Oswaldo Cruz, Sao Paulo, SP, BR.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Jukemura', 'Affiliation': 'Departamento de Gastroenterologia, Faculdade de Medicina (FMUSP), Universidade de Sao Paulo, SP, BR.'}, {'ForeName': 'Paulo Roberto Arruda', 'Initials': 'PRA', 'LastName': 'Alves', 'Affiliation': 'Hospital Alemao Oswaldo Cruz, Sao Paulo, SP, BR.'}, {'ForeName': 'Marcos Eduardo Lera Dos', 'Initials': 'MELD', 'LastName': 'Santos', 'Affiliation': 'Departamento de Gastroenterologia, Faculdade de Medicina (FMUSP), Universidade de Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1847']
2422,33206755,Clinical study on treatment of facial seborrheic dermatitis with intense pulsed light combined with 30% supramolecular salicylic acid.,"OBJECTIVES


In this study, we investigated the effects of intense pulsed light (IPL) combined with 30% supramolecular salicylic acid on facial seborrheic dermatitis.
METHODS


A total of 45 patients with mild or moderate facial seborrheic dermatitis were selected from our hospital between September 2018 and September 2019. The patients were divided into three groups consisting of 15 patients each. The first group was exposed to a combination of IPL and 30% supramolecular salicylic acid treatment, the second group was exposed to the IPL treatment alone, and the third group was exposed to the 30% supramolecular salicylic acid treatment alone. They were treated once every 4 weeks in three consecutive rounds.
RESULTS


Facial lesions and symptoms were observed 4 and 12 weeks after the first treatment, and adverse reactions were recorded. The combination group showed significant improvement in symptoms 4 weeks after the first treatment, while the individual treatment groups showed no significant improvement. After three rounds of treatments, seborrheic dermatitis had significantly decreased in the three groups; the efficacy of the combined treatment group was significantly higher than that of the IPL group and the 30% supramolecular salicylic acid group.
CONCLUSION


IPL combined with 30% supramolecular salicylic acid was effective in the treatment of facial seborrheic dermatitis and provided a quicker result with no adverse reactions.",2020,"The combination group showed significant improvement in symptoms 4 weeks after the first treatment, while the individual treatment groups showed no significant improvement.","['45 patients with mild or moderate facial seborrheic dermatitis were selected from our hospital between September 2018 and September 2019', 'facial seborrheic dermatitis']","['intense pulsed light (IPL) combined with 30% supramolecular salicylic acid', 'IPL and 30% supramolecular salicylic acid', 'IPL combined with 30% supramolecular salicylic acid', 'IPL', 'intense pulsed light combined with 30% supramolecular salicylic acid', 'IPL treatment alone, and the third group was exposed to the 30% supramolecular salicylic acid treatment alone']","['efficacy', 'adverse reactions', 'seborrheic dermatitis', 'facial seborrheic dermatitis', 'Facial lesions and symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1275433', 'cui_str': 'Facial seborrheic dermatitis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036079', 'cui_str': 'Salicylic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0036508', 'cui_str': 'Seborrheic dermatitis'}, {'cui': 'C1275433', 'cui_str': 'Facial seborrheic dermatitis'}, {'cui': 'C0743775', 'cui_str': 'Lesion of face'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",45.0,0.0169803,"The combination group showed significant improvement in symptoms 4 weeks after the first treatment, while the individual treatment groups showed no significant improvement.","[{'ForeName': 'Rui-Long', 'Initials': 'RL', 'LastName': 'Gu', 'Affiliation': 'Shanghai Huamei Medical Cosmetic Hospital, Shanghai, 200120, China.'}, {'ForeName': 'Shan-Qing', 'Initials': 'SQ', 'LastName': 'Wang', 'Affiliation': 'College of Aesthetic Medicine, Yichun University, Yichun, 336000, China.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1875']
2423,33206761,Continuous suprascapular nerve block compared with single-shot interscalene brachial plexus block for pain control after arthroscopic rotator cuff repair.,"OBJECTIVES


We compared the analgesic efficacy of a continuous suprascapular nerve block (C-SSNB) and a single-shot interscalene brachial plexus block (S-ISNB) for postoperative pain management in patients undergoing arthroscopic rotator cuff repair.
METHODS


A total of 118 patients undergoing arthroscopic rotator cuff repair were randomly allocated to the S-ISNB or C-SSNB groups. Postoperative pain was assessed using the visual analog scale (VAS) at 1, 2, 6, 12, and 24 h postoperatively. Supplemental analgesic use was recorded as total equianalgesic fentanyl consumption.
RESULTS


The C-SSNB group showed significantly higher VAS scores at 0-1 h and 1-2 h after the surgery than the S-ISNB group (4.9±2.2 versus 2.3±2.2; p<0.0001 and 4.8±2.1 versus 2.4±2.3; p<0.0001, respectively). The C-SSNB group showed significantly lower VAS scores at 6-12 h after the surgery than the S-ISNB group (4.1±1.8 versus. 5.0±2.5; p=0.031). The C-SSNB group required significantly higher doses of total equianalgesic fentanyl in the post-anesthesia care unit than the S-ISNB group (53.66±44.95 versus 5.93±18.25; p<0.0001). Total equianalgesic fentanyl in the ward and total equianalgesic fentanyl throughout the hospital period were similar between the groups (145.99±152.60 versus 206.13±178.79; p=0.052 and 199.72±165.50 versus 212.15±180.09; p=0.697, respectively).
CONCLUSION


C-SSNB was more effective than S-ISNB at 6-12 h after the surgery for postoperative analgesia after arthroscopic rotator cuff repair.",2020,"The C-SSNB group showed significantly higher VAS scores at 0-1 h and 1-2 h after the surgery than the S-ISNB group (4.9±2.2 versus 2.3±2.2; p<0.0001 and 4.8±2.1 versus 2.4±2.3; p<0.0001, respectively).","['pain control after arthroscopic rotator cuff repair', 'patients undergoing arthroscopic rotator cuff repair', '118 patients undergoing arthroscopic rotator cuff repair']","['continuous suprascapular nerve block (C-SSNB) and a single-shot interscalene brachial plexus block (S-ISNB', 'Continuous suprascapular nerve block compared with single-shot interscalene brachial plexus block']","['total equianalgesic fentanyl consumption', 'VAS scores', 'visual analog scale (VAS', 'total equianalgesic fentanyl', 'Postoperative pain', 'Total equianalgesic fentanyl', 'analgesic efficacy']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",118.0,0.0577596,"The C-SSNB group showed significantly higher VAS scores at 0-1 h and 1-2 h after the surgery than the S-ISNB group (4.9±2.2 versus 2.3±2.2; p<0.0001 and 4.8±2.1 versus 2.4±2.3; p<0.0001, respectively).","[{'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Korea.""}, {'ForeName': 'Kyungmoon', 'Initials': 'K', 'LastName': 'Roh', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Department of Anesthesiology and Pain Medicine, Eunpyeong St. Mary's Hospital, College of MedicineThe Catholic University of Korea, Korea.""}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Joo', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Korea.""}, {'ForeName': 'Sang Hyun', 'Initials': 'SH', 'LastName': 'Hong', 'Affiliation': ""Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Korea.""}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e2026']
2424,33206776,"Can kinematics, file diameter, and PUI influence the intracanal decontamination and apical bacterial extrusion?","The present study investigated the intracanal decontamination and apical extrusion of bacteria and debris from root canals instrumented with rotary and reciprocating systems (ProDesign Logic or ProDesign R), with different file diameters and using conventional syringe irrigation (CSI) or passive ultrasonic irrigation (PUI). Eighty extracted mandibular premolars were contaminated with Enterococcus faecalis and randomly assigned to eight experimental groups according to the root canal instrumentation and irrigation technique employed (n = 10): G1: Prodesign Logic 25.06; G2: Prodesign R 25.06; G3 and G4 were instrumented with the same single-file systems, respectively, using 35.05 diameters and CSI. G5, G6, G7, and G8 were instrumented like the previous groups, but with PUI. Apically extruded debris during instrumentation was collected into pre-weighed microtubes. The weight of the empty microtube was subtracted from the final weight to establish the amount of extruded debris. Bacteria from root canals and extruded debris were collected for a microbiological evaluation of colony forming units (CFU/mL). For statistical analyses, the Mann-Whitney and Kruskal-Wallis followed by the Dunn's tests were used (α = 0.05). All instruments caused extrusion of debris. For irrigation techniques, PUI promoted greater debris and bacterial extrusion (p < 0.05). The CFU/mL count indicated that the instrumentation of the experimental groups were equally effective in the decontamination of the root canal (p > 0.05). The systems tested (regarding file diameter and kinematics) were associated with similar amounts of apically extruded debris and root canal decontamination. PUI was associated with greater debris and bacterial extrusion.",2020,The CFU/mL count indicated that the instrumentation of the experimental groups were equally effective in the decontamination of the root canal (p > 0.05).,"['Eighty extracted mandibular premolars were contaminated with Enterococcus faecalis', 'n = 10']","['intracanal decontamination and apical extrusion of bacteria and debris from root canals instrumented with rotary and reciprocating systems (ProDesign Logic or ProDesign R), with different file diameters and using conventional syringe irrigation (CSI) or passive ultrasonic irrigation (PUI', 'root canal instrumentation and irrigation technique employed']","['weight of the empty microtube', 'debris and bacterial extrusion', 'extrusion of debris']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023963', 'cui_str': 'Logic'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C2959650', 'cui_str': 'Irrigation technique'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}]",80.0,0.0207826,The CFU/mL count indicated that the instrumentation of the experimental groups were equally effective in the decontamination of the root canal (p > 0.05).,"[{'ForeName': 'Maricel Rosario Cardenas', 'Initials': 'MRC', 'LastName': 'Cuellar', 'Affiliation': 'Universidade de São Paulo - USP, Bauru School of Dentistry, Department of Operative Dentistry, Endodontics and Dental Materials, Bauru, SP, Brazil.'}, {'ForeName': 'Evelyn Giuliana', 'Initials': 'EG', 'LastName': 'Velásquez-Espedilla', 'Affiliation': 'Universidade de São Paulo - USP, Bauru School of Dentistry, Department of Operative Dentistry, Endodontics and Dental Materials, Bauru, SP, Brazil.'}, {'ForeName': 'Victor Feliz', 'Initials': 'VF', 'LastName': 'Pedrinha', 'Affiliation': 'Universidade de São Paulo - USP, Bauru School of Dentistry, Department of Operative Dentistry, Endodontics and Dental Materials, Bauru, SP, Brazil.'}, {'ForeName': 'Rodrigo Ricci', 'Initials': 'RR', 'LastName': 'Vivan', 'Affiliation': 'Universidade de São Paulo - USP, Bauru School of Dentistry, Department of Operative Dentistry, Endodontics and Dental Materials, Bauru, SP, Brazil.'}, {'ForeName': 'Marco Antonio Hungaro', 'Initials': 'MAH', 'LastName': 'Duarte', 'Affiliation': 'Universidade de São Paulo - USP, Bauru School of Dentistry, Department of Operative Dentistry, Endodontics and Dental Materials, Bauru, SP, Brazil.'}, {'ForeName': 'Flaviana Bombarda de', 'Initials': 'FB', 'LastName': 'Andrade', 'Affiliation': 'Universidade de São Paulo - USP, Bauru School of Dentistry, Department of Operative Dentistry, Endodontics and Dental Materials, Bauru, SP, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2021.vol35.0003']
2425,33206786,Whole purple grape juice increases nitric oxide production after training session in high level beach handball athletes.,"Aims to evaluate the effect of whole purple grape juice intake in the recovery of oxidative stress, inflammation and muscle injury after an intense training session. Fifteen high level men athletes were randomly distributed in supplemented (GJG; n=8; 28.7 ± 3.5 years) or control group (CG; n=7; 24.8 ± 2.7 years). 400 ml of juice or water was ingested immediately before (200 ml) and after (200 ml) a training session. Blood samples was collect before and post-training session as well as 180 minutes after this session (recovery) to analysis of creatine kinase (CK), lactate dehydrogenase (LDH), C-reactive ultrasensitive protein (CRP), malondialdehyde (MDA) and nitrite. The nitrite values at the end of recovery moment of the GJG group were significantly higher than the same moment in the CG group (p<0.05), and the intra-group analysis showed a significant increase in nitrite values only in the GJG group in the end of recovery period moment when compared to the moments pre-training (p<0.001) and post-training (p<0.05). MDA, CRP, LDH and CK did not differ neither groups. Acute supplementation with 400 ml of grape juice increases the serum concentration of nitrite, a nitric oxide metabolite that has antioxidant activity.",2020,"Acute supplementation with 400 ml of grape juice increases the serum concentration of nitrite, a nitric oxide metabolite that has antioxidant activity.","['high level beach handball athletes', 'Fifteen high level men athletes']","['Acute supplementation with 400 ml of grape juice', 'whole purple grape juice intake', 'Whole purple grape juice', 'GJG']","['serum concentration of nitrite, a nitric oxide metabolite', 'nitrite values', 'MDA, CRP, LDH and CK', 'creatine kinase (CK), lactate dehydrogenase (LDH), C-reactive ultrasensitive protein (CRP), malondialdehyde (MDA) and nitrite', 'nitric oxide production', 'oxidative stress, inflammation and muscle injury']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0331781', 'cui_str': 'Beach'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0439542', 'cui_str': 'Purple'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410256', 'cui_str': 'Injury of muscle'}]",,0.0649791,"Acute supplementation with 400 ml of grape juice increases the serum concentration of nitrite, a nitric oxide metabolite that has antioxidant activity.","[{'ForeName': 'Manoel', 'Initials': 'M', 'LastName': 'Miranda Neto', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Nutrição, Universidade Federal da Paraíba, Departamento de Nutrição, Campus I, Loteamento, Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}, {'ForeName': 'Lydiane L T', 'Initials': 'LLT', 'LastName': 'Toscano', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Nutrição, Universidade Federal da Paraíba, Departamento de Nutrição, Campus I, Loteamento, Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}, {'ForeName': 'Renata L', 'Initials': 'RL', 'LastName': 'Tavares', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Nutrição, Universidade Federal da Paraíba, Departamento de Nutrição, Campus I, Loteamento, Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}, {'ForeName': 'Luciana T', 'Initials': 'LT', 'LastName': 'Toscano', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Nutrição, Universidade Federal da Paraíba, Departamento de Nutrição, Campus I, Loteamento, Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}, {'ForeName': 'Orranette P', 'Initials': 'OP', 'LastName': 'Padilhas', 'Affiliation': 'Programa Associado de Pós-Graduação em Educação Física, UFPE/UFPB, Departamento de Educação Física, Campus I, Loteamento Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}, {'ForeName': 'CÁssia S O DA', 'Initials': 'CSOD', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Nutrição, Universidade Federal da Paraíba, Departamento de Nutrição, Campus I, Loteamento, Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}, {'ForeName': 'Gilberto S', 'Initials': 'GS', 'LastName': 'Cerqueira', 'Affiliation': 'Programa de Pós-Graduação em Ciências Morfofuncionais, Universidade Federal do Ceará, Departamento de Morfologia, Campus Porangabussu, Rua Delmiro de Farias, s/n, Rodolfo Teófilo, 60430-170 Fortaleza, CE, Brazil.'}, {'ForeName': 'Alexandre S', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós-Graduação em Ciências da Nutrição, Universidade Federal da Paraíba, Departamento de Nutrição, Campus I, Loteamento, Cidade Universitária, 58051-900 João Pessoa, PB, Brazil.'}]",Anais da Academia Brasileira de Ciencias,['10.1590/0001-3765202020191371']
2426,33209401,Antitussive effect of a magnesium infusion during anesthetic emergence in patients with double-lumen endotracheal tube: a randomized controlled trial.,"Background


A double-lumen endotracheal tube (DLT) inserted into the bronchus can stimulate the respiratory tracts, causing coughing. Opioids have been introduced to prevent emergence cough. However, the administration of a significant opioid dose at the end of surgery may result in undesirable events. Magnesium, common intracellular ion, suppress bronchial smooth muscle contraction and have antitussive effect. We investigated the antitussive effects of a magnesium infusion during anesthetic emergence in patients who underwent thoracic surgery requiring one-lung ventilation (OLV) anesthesia with a DLT.
Methods


One-hundred forty patients undergoing OLV anesthesia with a DLT were enrolled in this prospective, randomized double-blinded trial. In combination with a low dose of remifentanil, patients were randomly allocated to receive either magnesium sulphate (infusion of 15 mg/kg/hour after a single bolus of 30 mg/kg) or normal saline during the operation and emergence. Primary outcomes were the severity and incidence of cough during emergence.
Results


The severity of cough was assessed by the cough severity grading score: 0, no cough; 1, single cough; 2, cough persistence <5 seconds; 3, cough persistence ≥5 seconds. There was a significant difference in the severity score of cough between the groups [median (IQR): 2 (0 to 3) in control group  vs.  0 (0 to 1) in magnesium group, P=0.003]. However, there was no significant difference in the overall incidence of cough between both groups [42 (64.6%) in control group  vs.  31 (47.7%) in magnesium group, P=0.077].
Conclusions


Magnesium attenuated the severity of cough during emergence after OLV anesthesia using a DLT without adverse events.",2020,"However, there was no significant difference in the overall incidence of cough between both groups [42 (64.6%) in control group  vs.  31 (47.7%) in magnesium group, P=0.077].
","['hundred forty patients undergoing OLV anesthesia with a DLT', 'patients with double-lumen endotracheal tube', 'patients who underwent thoracic surgery requiring one-lung ventilation (OLV) anesthesia with a DLT']","['magnesium infusion', 'remifentanil', 'Magnesium', 'magnesium sulphate', 'normal saline', '\n\n\nA double-lumen endotracheal tube (DLT']","['0, no cough; 1, single cough; 2, cough persistence <5 seconds; 3, cough persistence ≥5 seconds', 'overall incidence of cough', 'cough severity grading score', 'severity and incidence of cough during emergence', 'severity score of cough', 'severity of cough']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}]","[{'cui': 'C0425502', 'cui_str': 'No cough'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",140.0,0.513702,"However, there was no significant difference in the overall incidence of cough between both groups [42 (64.6%) in control group  vs.  31 (47.7%) in magnesium group, P=0.077].
","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Hur', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Dae Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Han-Bit', 'Initials': 'HB', 'LastName': 'Shin', 'Affiliation': 'Office of Biostatistics, Medical Research Collaboration Center, Ajou Research Institute for Innovative Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Bumhee', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Office of Biostatistics, Medical Research Collaboration Center, Ajou Research Institute for Innovative Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Myungseob', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Eunjeong', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, Suwon, Korea.'}]",Journal of thoracic disease,['10.21037/jtd-20-1977']
2427,33209620,GEMSTONE-301: a phase III clinical trial of CS1001 as consolidation therapy in patients with locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) who did not have disease progression after prior concurrent/sequential chemoradiotherapy.,"Background


In China, platinum-based doublet chemotherapy is the standard treatment for patients who have unresectable stage III non-small cell lung cancer (NSCLC), administered with radiotherapy on either a concurrent or sequential basis. However, NSCLC patients who undergo this treatment can expect poor median progression-free survival (PFS) of around 8-10 months and a dismal 5-year overall survival (OS) rate of about 15%. In the recent PACIFIC trial, durvalumab was demonstrated to hold significant clinical benefit for patients with locally advanced/unresectable NSCLC who experienced no disease progression after definitive concurrent chemoradiotherapy (cCRT). CS1001 is the first full-length, fully human immunoglobin G4 (IgG4) monoclonal antibody (mAb) that targets programmed death ligand-1 (PD-L1) created through the OMT transgenic rat platform. The phase Ia/Ib study indicated CS1001 was well tolerated and exhibited anti-tumor potential with a range of tumors. GEMSTONE-301 is a phase III randomized, double-blind, study to explore the efficacy and safety of CS1001 compared with a placebo as consolidation therapy for stage III unresectable NSCLC patients.
Methods


In this trial, eligible patients will be randomized to receive CS1001 1,200 mg or placebo, every 3 weeks (Q3W). The primary endpoint will be investigator-assessed PFS, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The secondary endpoints will include OS, PFS assessment based on Blinded Independent Center Review (BICR), objective response rate (ORR), other efficacy measurements, safety, and tolerability.
Discussion


This phase III trial will determine the efficacy and safety of CS1001 as consolidation therapy in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after prior concurrent/sequential chemoradiotherapy (cCRT or sCRT), and is the first phase III trial on an anti-PD-L1 mAb initiated in China for this indication.
Protocol version


Version 3.0/September 12, 2019.",2020,Ib study indicated CS1001 was well tolerated and exhibited anti-tumor potential with a range of tumors.,"['patients who have unresectable stage III non-small cell lung cancer (NSCLC', 'patients with locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) who did not have disease progression after prior concurrent/sequential chemoradiotherapy', 'patients with locally advanced/unresectable NSCLC who experienced no disease progression after definitive concurrent chemoradiotherapy (cCRT', 'patients with locally advanced/unresectable (stage III', 'stage III unresectable NSCLC patients']","['CS1001', 'CS1001 1,200 mg or placebo', 'sequential chemoradiotherapy (cCRT or sCRT', 'placebo', 'China, platinum-based doublet chemotherapy', 'radiotherapy']","['median progression-free survival (PFS', 'efficacy and safety', 'dismal 5-year overall survival (OS) rate', 'OS, PFS assessment based on Blinded Independent Center Review (BICR), objective response rate (ORR), other efficacy measurements, safety, and tolerability', 'investigator-assessed PFS, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]",,0.342923,Ib study indicated CS1001 was well tolerated and exhibited anti-tumor potential with a range of tumors.,"[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Jiang', 'Affiliation': ""The Second People's Hospital of Neijiang, Sichuan Medical University, Neijiang, China.""}, {'ForeName': 'Jiu-Wei', 'Initials': 'JW', 'LastName': 'Cui', 'Affiliation': 'The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Cancer Hospital, The First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Gong-Yan', 'Initials': 'GY', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.""}]",Translational lung cancer research,['10.21037/tlcr-20-608']
2428,33209681,"The clinical research of 1,470 nm laser in percutaneous nephrolithotomy.","Background


Percutaneous nephrolithotomy (PCNL) is the primary method for the treatment of renal calculi. The preservation of the nephrostomy tube after operation brings severe pain to the patients. We use a 1,470 nm semiconductor laser to stop bleeding after the operation, which cannot reserve the nephrostomy tube, fully reflect its safety and effectiveness, and provide a new method for clinical practice.
Methods


Forty-two patients with renal stones who came to our hospital from March 2016 to September 2019 were randomly divided into two groups: laser operation group (20 patients) and traditional operation group (22 patients). The stone removal rate, surgical effect, and postoperative complications were compared between the two groups.
Results


There was no significant difference in the stone clearance rate between the two groups at the 4th week after operation (P>0.05). However, the incidence of postoperative infection, incision pain, and massive bleeding in the laser surgery group were lower than those in the traditional surgery group (P<0.05). However, there was no significant difference in urine extravasation and postoperative hematuria between the two groups (P>0.05). The average postoperative hospital stay in the laser surgery group was shorter than that in the traditional surgery group, and the difference was statistically significant (P<0.05). Simultaneously, there was no significant difference in operation time, intraoperative blood loss, and medical expenses between the two groups (P>0.05).
Conclusions


The 1,470 nm laser is safe, effective, and feasible in PCNL operation, especially in hemostasis of the renal puncture channel, and it is worth popularizing.",2020,There was no significant difference in the stone clearance rate between the two groups at the 4th week after operation (P>0.05).,['Methods\n\n\nForty-two patients with renal stones who came to our hospital from March 2016 to September 2019'],"['1,470 nm semiconductor laser', '1,470 nm laser in percutaneous nephrolithotomy', '\n\n\nPercutaneous nephrolithotomy (PCNL', 'laser operation group (20 patients) and traditional operation group']","['operation time, intraoperative blood loss, and medical expenses', 'urine extravasation and postoperative hematuria', 'stone clearance rate', 'average postoperative hospital stay', 'postoperative infection, incision pain, and massive bleeding', 'stone removal rate, surgical effect, and postoperative complications']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333279', 'cui_str': 'Massive hemorrhage'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",42.0,0.0115764,There was no significant difference in the stone clearance rate between the two groups at the 4th week after operation (P>0.05).,"[{'ForeName': 'Yunwu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Basic Laboratory, the Second Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Hongye', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Urology, the Second Affiliated Hospital of Wannan Medical College, Wuhu, China.'}]",Translational andrology and urology,['10.21037/tau-20-1224']
2429,33209687,The use of a homemade rate adjustment card in patients with continuous bladder irrigation after transurethral resection of the prostate.,"Background


In China, the incidence of benign prostatic hyperplasia (BPH) is rising with the average lifespan of men. Transurethral resection of the prostate (TURP) is recognized as the gold standard for surgical treatment of BPH. Continuous bladder irrigation (CBI) is often required after operation. The irrigation rate is often manually adjusted based on the color of the drainage fluid, but it is difficult to know how much to adjust it based on color. To better adjust the irrigation rate and reduce related complications, we developed and evaluated a post-TURP CBI rate adjustment card.
Methods


A total of 103 BPH patients who underwent post-TURP CBI at our hospital between April and July 2020 were enrolled in this study and were assigned to the control group (n=49) or the experimental group (n=54) according to the different hospital areas. In the control group, the CBI rate was adjusted based on the clinical evaluation of the color of the drainage fluid; in the experimental group, the CBI rate was adjusted based on the color of drainage fluid evaluated with our homemade post-TURP CBI rate adjustment card.
Results


The incidence of bladder spasm, the incidence of clot-related catheter blockage, the volume of irrigation solution used, and the irrigation time were significantly lower or shorter in the experimental group than in the control group. The patient satisfaction score was significantly higher in the experimental group (P<0.05).
Conclusions


For BPH patients receiving post-TURP CBI, the homemade post-TURP CBI rate adjustment card can provide objective data for clinical care, reduce postoperative complications, and improve patient satisfaction. Therefore, it should be more widely used in clinical practice.",2020,"The patient satisfaction score was significantly higher in the experimental group (P<0.05).
","['patients with continuous bladder irrigation after transurethral resection of the prostate', '103 BPH patients who underwent post-TURP CBI at our hospital between April and July 2020 were enrolled in this study and were assigned to the control group (n=49) or the experimental group (n=54) according to the different hospital areas']","['Transurethral resection of the prostate (TURP', 'Continuous bladder irrigation (CBI']","['incidence of bladder spasm, the incidence of clot-related catheter blockage, the volume of irrigation solution used, and the irrigation time', 'CBI rate', 'patient satisfaction score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0194423', 'cui_str': 'Irrigation of urinary bladder'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0194423', 'cui_str': 'Irrigation of urinary bladder'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0426390', 'cui_str': 'Spasm of bladder'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0948808', 'cui_str': 'Catheter blockage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0194423', 'cui_str': 'Irrigation of urinary bladder'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",103.0,0.0208769,"The patient satisfaction score was significantly higher in the experimental group (P<0.05).
","[{'ForeName': 'Zheng-Zheng', 'Initials': 'ZZ', 'LastName': 'Ma', 'Affiliation': 'Department of Urology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yan-Xia', 'Initials': 'YX', 'LastName': 'Han', 'Affiliation': 'Department of Nursing, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Wei-Zhen', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Kan', 'Affiliation': ""Department of Nursing, Liyang Branch of Jiangsu Provincial People's Hospital, Changzhou, China.""}, {'ForeName': 'Mei-E', 'Initials': 'ME', 'LastName': 'Niu', 'Affiliation': 'Department of Nursing, First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Translational andrology and urology,['10.21037/tau-20-1288']
2430,33209809,Effect of nurse-led home-based biofeedback intervention on the blood pressure levels among patients with hypertension: Pretest-posttest study.,"Aim


To investigate the effect of nurse-led home-based biofeedback intervention on the blood pressure levels among patients with hypertension.
Background


Nurse-led interventions are emerging as cost-effective as well as clinically proven in chronic illness management. Hypertension, a leading long-term cardiovascular condition, has autonomic dysregulation and increased sympathetic tone as its pathophysiological background. Complementary interventions evidenced to interplay hypertension pathophysiology.
Design


A pretest-posttest design.
Materials and Methods


Uncomplicated primary hypertension outpatients were randomly assigned as study group ( n  = 173) and control group ( n  = 173) at a tertiary care hospital. Sociodemographic, clinical, and outcome variables [the baseline blood pressure and galvanic skin response (GSR)] were collected. Study group patients were given four teaching sessions of abdominal breathing-assisted relaxation facilitated by GSR biofeedback. Daily home practice was encouraged and monitored to measure the effects on blood pressure and GSR at the end of the 1 st , 2 nd , and 3 rd  month of intervention.
Results


The study group participants showed significant decrease in mean (SD) systolic [140.77 (8.31) to 136.93 (7.96),  F  = 469.08] and diastolic blood pressure [88.24 (5.42) to 85.77 (4.66),  F  = 208.21]. In contrast, control group participants had a mild increase in the mean systolic ( F  = 6.02) and diastolic blood pressure ( F  = 4.70) values from pretest to posttests. GSR showed a significant increase from 559.63 (226.33) to 615.03 (232.24), ( F  = 80.21) from pretest to posttest III.
Conclusions


Use of home-based biofeedback-centered behavioral interventions enabled BP reduction among hypertensive patients. Further studies should use biochemical markers of sympathetic nervous system activity to endorse this home-based chronic illness intervention.",2020,"In contrast, control group participants had a mild increase in the mean systolic ( F  = 6.02) and diastolic blood pressure ( F  = 4.70) values from pretest to posttests.","['hypertensive patients', 'Materials and Methods\n\n\nUncomplicated primary hypertension outpatients', 'patients with hypertension']","['home-based biofeedback-centered behavioral interventions', 'nurse-led home-based biofeedback intervention', 'teaching sessions of abdominal breathing-assisted relaxation facilitated by GSR biofeedback']","['blood pressure and GSR', 'GSR', 'mean (SD) systolic', 'baseline blood pressure and galvanic skin response (GSR', 'BP reduction', 'mean systolic', 'diastolic blood pressure', 'blood pressure levels']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0170479,"In contrast, control group participants had a mild increase in the mean systolic ( F  = 6.02) and diastolic blood pressure ( F  = 4.70) values from pretest to posttests.","[{'ForeName': 'Sujitha', 'Initials': 'S', 'LastName': 'Elavally', 'Affiliation': 'Department of Medical Surgical Nursing, Government College of Nursing, Thrissur, Kerala, India.'}, {'ForeName': 'Muralidharan Thoddi', 'Initials': 'MT', 'LastName': 'Ramamurthy', 'Affiliation': 'Department of Cardiology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Jeyagowri', 'Initials': 'J', 'LastName': 'Subash', 'Affiliation': 'Department of Paediatric Nursing, College of Nursing, East-Coast Institute of Medical Sciences, Puthucherry, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Meleveedu', 'Affiliation': 'Department of Accident and Emergency Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Munikumar Ramasamy', 'Initials': 'MR', 'LastName': 'Venkatasalu', 'Affiliation': 'Department of Nursing, Oxford School of Nursing and Midwifery, Faculty of Health and Life Sciences, Oxford Brookes University, MR1/02 | Marston Road Campus, Jack Straws Lane, Headington, Oxford, United Kingdom.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_210_20']
2431,33209822,Clinical efficacy of amino bisphosphonate on periodontal disease status in postmenopausal women: Randomized double-blind placebo-controlled trial.,"Objectives


Osteoporosis is a common skeletal disorder affecting postmenopausal women. Data suggest that postmenopausal women are at increased risk of periodontal diseases. Amino bisphosphonates are potent inhibitors of bone resorption and effectively used in the treatment of osteoporosis. Preliminary data indicate that there is a potential role for bisphosphonates in the management of periodontitis. Hence, this randomized placebo-controlled trial was designed to investigate the clinical efficacy of amino bisphosphonate on periodontal disease status among postmenopausal women.
Materials and Methods


Thirty patients were randomly allocated to two treatment groups: Group A, which received scaling and root debridement and 70 mg weekly single oral dose of alendronate drug, and Group B, which received scaling and root debridement and placebo drug for 6 months. Clinical periodontal measurements were carried out for all patients at the baseline and 6 months later. Mandibular bone mineral density (BMD) was measured using a dual energy X-ray absorptiometer at the beginning of the study and the end of 6 months.
Results


A weekly single oral dose of 70 mg alendronate was well-tolerated. The intragroup comparison showed significant improvement in periodontal parameters in both groups. The intergroup comparison showed a significant increase in BMD after 6 months in Group A when compared with Group B ( P  = 0.0179).
Conclusion


Single oral dose of 70 mg alendronate per week is well-tolerable, gastro-intestinally safe, and improves the clinical outcome of nonsurgical periodontal therapy.",2020,"The intergroup comparison showed a significant increase in BMD after 6 months in Group A when compared with Group B ( P  = 0.0179).
","['Materials and Methods\n\n\nThirty patients', 'postmenopausal women']","['scaling and root debridement and 70 mg weekly single oral dose of alendronate drug, and Group B, which received scaling and root debridement and placebo', 'amino bisphosphonate', 'alendronate', 'Amino bisphosphonates', 'placebo', 'bisphosphonates']","['risk of periodontal diseases', 'periodontal parameters', 'Mandibular bone mineral density (BMD', 'periodontal disease status', 'BMD']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",30.0,0.166438,"The intergroup comparison showed a significant increase in BMD after 6 months in Group A when compared with Group B ( P  = 0.0179).
","[{'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Periodontics, RUHS College of Dental Sciences, Jaipur, Rajasthan, India.'}, {'ForeName': 'Setu', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Department of Periodontics, RUHS College of Dental Sciences, Jaipur, Rajasthan, India.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Department of Periodontics, RUHS College of Dental Sciences, Jaipur, Rajasthan, India.'}, {'ForeName': 'Sharmistha', 'Initials': 'S', 'LastName': 'Vijay', 'Affiliation': 'Department of Periodontics, RUHS College of Dental Sciences, Jaipur, Rajasthan, India.'}, {'ForeName': 'Rohit K', 'Initials': 'RK', 'LastName': 'Khatri', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, RUHS College of Dental Sciences, Jaipur, Rajasthan, India.'}, {'ForeName': 'Rashi', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Department of Oral Pathology, Rajasthan Dental College, Jaipur, Rajasthan, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_724_20']
2432,33209881,Adjuvant apatinib treatment after resection of hepatocellular carcinoma with portal vein tumor thrombosis: a phase II trial.,"Background


Survival after resection of hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) still remains poor. Apatinib, a vascular endothelial cell growth factor receptor 2 inhibitor, has been shown to be safe and effective in patients with advanced HCC, so in the present study its efficacy and safety in the adjuvant setting was explored.
Methods


In this single-center, open-label phase II trial, the patients received apatinib (500 mg/day) until they experienced disease recurrence or intolerable toxicity. The primary endpoint was recurrence-free survival (RFS); the secondary endpoints included overall survival (OS) and safety.
Results


From a total of 49 patients who were screened between August 2017 and December 2018, 30 study participants received apatinib. According to the Liver Cancer Study Group of Japan classification of PVTT, there were 7, 11, and 12 participants with Vp1, Vp2, and Vp3, respectively. The median duration of treatment was 4.8 months [interquartile range (IQR): 2.0-8.8], and the median dose of apatinib was 339.7 mg/day (IQR: 267.7-500 mg/day). The median follow-up was 14.3 months (IQR: 12.3-19.3). The median RFS was 7.6 months [95% confidence interval (CI): 5.7-9.5 months]. The 1-year RFS rate and the 1-year OS rate were 36.1% and 93.3%, respectively. A total of 29 (96.7%) patients experienced adverse events, and 14 (46.7%) had grade 3 or 4 adverse events. No treatment-related deaths occurred.
Conclusions


Apatinib was well tolerated in patients after resection of HCC with PVTT. The median RFS in this group was improved compared with that previously reported.
Trial registration


No.: NCT03261791 (ClinicalTrials.gov).",2020,The median RFS was 7.6 months [95% confidence interval (CI): 5.7-9.5 months].,"['49 patients who were screened between August 2017 and December 2018, 30 study participants received apatinib', 'hepatocellular carcinoma with portal vein tumor thrombosis', 'patients with advanced HCC', 'patients after resection of HCC with PVTT']",['Adjuvant apatinib treatment'],"['disease recurrence or intolerable toxicity', 'recurrence-free survival (RFS', 'adverse events', 'median RFS', '1-year RFS rate and the 1-year OS rate', 'median duration of treatment', 'overall survival (OS) and safety', 'grade 3 or 4 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C2242635', 'cui_str': 'Tumour thrombosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",30.0,0.368852,The median RFS was 7.6 months [95% confidence interval (CI): 5.7-9.5 months].,"[{'ForeName': 'Hui-Chuan', 'Initials': 'HC', 'LastName': 'Sun', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhu', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying-Hong', 'Initials': 'YH', 'LastName': 'Shi', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zhen-Bing', 'Initials': 'ZB', 'LastName': 'Ding', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shuang-Jian', 'Initials': 'SJ', 'LastName': 'Qiu', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ren', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guo-Ming', 'Initials': 'GM', 'LastName': 'Shi', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qing-Hai', 'Initials': 'QH', 'LastName': 'Ye', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiao-Wu', 'Initials': 'XW', 'LastName': 'Huang', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xin-Rong', 'Initials': 'XR', 'LastName': 'Yang', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Annals of translational medicine,['10.21037/atm-20-6181']
2433,33209914,Enhancing polycystic ovarian syndrome awareness using private social network.,"Background


The purpose of the study is to evaluate the effectiveness of mobile health technology such as private social network (PCOS system) in creating awareness about the disease management among the women diagnosed with the polycystic ovarian syndrome.
Methods


A pilot study was conducted in Tabuk, Saudi Arabia. The study was carried out for a period of three months using a private social network as an intervention. The private social network is used as an interface to educate and create awareness among the participants in the study. Fifty women diagnosed with PCOS were randomly selected and were distributed in to control group (doesn't use PCOS system) and intervention group (use the private social network). The level of the polycystic ovarian syndrome awareness was measured using a structured questionnaire at the beginning and end of the follow-up period.
Results


More than 80 posts and 10 pictures contain data about PCOS were conveyed by medical staff. Also, about 120 private SMS messages between medical staff and the patients were refined. The after effects of this investigation demonstrated that the intervention had better awareness about polycystic ovary syndrome management compared to the control group (F =18.25; P<0.0001).
Conclusions


This study of the private social network among the PCOS patients demonstrated that mobile health technology such as the private social network can substantially enhance the PCOS disease awareness levels among Saudi women. The PCOS System can also help in reducing the costs as most of the disease management process is handled over the application through the messages and feedbacks is provided through the application, and in saving time by avoiding hospital visits. This study is first-of-its kind conducted in Saudi Arabia.",2020,"The after effects of this investigation demonstrated that the intervention had better awareness about polycystic ovary syndrome management compared to the control group (F =18.25; P<0.0001).
","['women diagnosed with the polycystic ovarian syndrome', 'Tabuk, Saudi Arabia', 'Saudi Arabia', 'Fifty women diagnosed with PCOS', 'Saudi women']",['mobile health technology such as private social network (PCOS system'],"['awareness about polycystic ovary syndrome management', 'level of the polycystic ovarian syndrome awareness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.0222061,"The after effects of this investigation demonstrated that the intervention had better awareness about polycystic ovary syndrome management compared to the control group (F =18.25; P<0.0001).
","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alotaibi', 'Affiliation': 'Faculty of Computers and Information Technology, University of Tabuk, Tabuk, Saudi Arabia.'}, {'ForeName': 'Amani Ali', 'Initials': 'AA', 'LastName': 'Shaman', 'Affiliation': 'Faculty of Medicine, University of Tabuk, Tabuk, Saudi Arabia.'}]",mHealth,['10.21037/mhealth.2019.12.02']
2434,33211928,Screening and Intervention to Prevent Falls and Fractures in Older People.,"BACKGROUND


Community screening and therapeutic prevention strategies may reduce the incidence of falls in older people. The effects of these measures on the incidence of fractures, the use of health resources, and health-related quality of life are unknown.
METHODS


In a pragmatic, three-group, cluster-randomized, controlled trial, we estimated the effect of advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise for people at increased risk for falls) as compared with advice by mail only. The primary outcome was the rate of fractures per 100 person-years over 18 months. Secondary outcomes were falls, health-related quality of life, frailty, and a parallel economic evaluation.
RESULTS


We randomly selected 9803 persons 70 years of age or older from 63 general practices across England: 3223 were assigned to advice by mail alone, 3279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail. A falls-risk screening questionnaire was sent to persons assigned to the exercise and multifactorial fall-prevention groups. Completed screening questionnaires were returned by 2925 of the 3279 participants (89%) in the exercise group and by 2854 of the 3301 participants (87%) in the multifactorial fall-prevention group. Of the 5779 participants from both these groups who returned questionnaires, 2153 (37%) were considered to be at increased risk for falls and were invited to receive the intervention. Fracture data were available for 9802 of the 9803 participants. Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71). The exercise strategy was associated with small gains in health-related quality of life and the lowest overall costs. There were three adverse events (one episode of angina, one fall during a multifactorial fall-prevention assessment, and one hip fracture) during the trial period.
CONCLUSIONS


Advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls did not result in fewer fractures than advice by mail alone. (Funded by the National Institute of Health Research; ISRCTN number, ISRCTN71002650.).",2020,"Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71).","['Older People', '9802 of the 9803 participants', 'older people', '9803 persons 70 years of age or older from 63 general practices across England: 3223 were assigned to', '5779 participants from both these groups who returned questionnaires, 2153 (37%) were considered to be at increased risk for falls and were invited to receive the intervention', '3279 participants (89%) in the exercise group and by 2854 of the 3301 participants (87%) in the multifactorial fall-prevention group']","['advice by mail alone, 3279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail', 'advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise']","['falls, health-related quality of life, frailty, and a parallel economic evaluation', 'rate ratio for fracture with exercise', 'rate of fractures per 100 person-years', 'small gains in health-related quality of life', 'rate ratio with multifactorial fall prevention']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}]",9803.0,0.0799818,"Screening and targeted intervention did not result in lower fracture rates; the rate ratio for fracture with exercise as compared with advice by mail was 1.20 (95% confidence interval [CI], 0.91 to 1.59), and the rate ratio with multifactorial fall prevention as compared with advice by mail was 1.30 (95% CI, 0.99 to 1.71).","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Anower', 'Initials': 'A', 'LastName': 'Hossain', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Longo', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bojke', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Withers', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Finnegan', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Sheridan', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Willett', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'From the Institute of Health Research, University of Exeter (S.E.L., C.H., R.S.), and Royal Devon and Exeter Hospital (R.S.), Exeter, the Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick (J.B., C.J., R. Lall, E.W., S.F., M.U.), and University Hospitals Coventry and Warwickshire (M.U.), Coventry, Leeds Institute of Health Sciences, University of Leeds, Leeds (R. Longo, C.B.), and the Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford (K.W.) - all in the United Kingdom, and the Institute of Statistical Research and Training, University of Dhaka, Dhaka, Bangladesh (A.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001500']
2435,33212067,"Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study.","BACKGROUND


Three doses of the licensed tetravalent dengue vaccine CYD-TDV (Dengvaxia, Sanofi Pasteur, Lyon France) are immunogenic and effective against symptomatic dengue in individuals aged 9 years and older who are dengue seropositive. Previous trials have provided some evidence that antibody responses elicited after just one dose or two doses of CYD-TDV might be similar to those elicited after three doses. We compared antibody responses following one-dose, two-dose, and three-dose vaccination regimens in individuals who were dengue seropositive at baseline up to 1 year after the last injection.
METHODS


In this randomised, controlled, phase 2, non-inferiority study (CYD65), healthy individuals aged 9-50 years were recruited from the community in three sites in Colombia and three sites in the Philippines. Participants were randomly assigned (1:1:1), using a permuted block method with stratification by site and age group, to receive, at 6-month intervals (on day 0, month 6, and month 12), three doses of CYD-TDV (three-dose group), one dose of placebo (on day 0) and two doses of CYD-TDV (at months 6 and 12; two-dose group), or two doses of placebo (on day 0 and month 6) and one dose of CYD-TDV (at month 12; one-dose group). Each dose of CYD-TDV was 0·5 mL, administered subcutaneously into the deltoid of the upper arm. Participants, study staff, investigators, and the funder were masked to group assignment. The co-primary endpoints were geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype at 28 days and 1 year after the last vaccine injection. After a protocol amendment during the conduct of the study, the original co-primary objectives of non-inferiority of the one-dose and two-dose groups to the three-dose group were altered to include non-inferiority of the two-dose group to the three-dose group only, to be assessed in individuals who were dengue seropositive at baseline. Non-inferiority was shown if the lower limit of the 95% CI for the ratio of GMTs (GMR) at 28 days and 1 year between groups was more than 0·5 for each serotype. The analysis of the coprimary objectives was done in the per-protocol analysis dataset, which included all participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection. Safety was assessed throughout in all participants who received at least one injection of study drug, regardless of serostatus. This trial is registered with ClinicalTrials.gov, NCT02628444, and is closed to accrual.
FINDINGS


Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group). 860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline. Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed: 272 [two-dose group], 265 [three-dose group] at 28 days; and 190 [two-dose group], 185 [three-dose group] at 1 year). At 28 days after the last injection, neutralising antibody GMTs were 899 (95% CI 752-1075) in the two-dose group versus 822 (700-964) in the three dose group against dengue serotype 1 (GMR 1·09 [95% CI 0·86-1·39]); 869 (754-1002) versus 875 (770-995) against serotype 2 (GMR 0·99 [0·82-1·20]); 599 (524-685) versus 610 (535-694) against serotype 3 (GMR 0·98 [0·82-1·18]); and 510 (453-575) versus 531 (470-601) against serotype 4 (GMR 0·96 [0·81-1·14]). At year 1, GMTs had decreased but remained above baseline for all serotypes: 504 (95% CI 403-630) in the two-dose group versus 490 (398-604) in the three-dose group against serotype 1 (GMR 1·03 [0·76-1·40]); 737 (611-888) versus 821 (704-957) against serotype 2 (GMR 0·90 [0·71-1·14]); 437 (368-519) versus 477 (405-561) against serotype 3 (GMR 0·92 [0·72-1·16]); and 238 (205-277) versus 270 (235-310) against serotype 4 (GMR 0·88 [0·72-1·09]). Reactogenicity profiles were similar across treatment groups. Most unsolicited adverse events after any injection were non-serious and systemic in nature. During the study, 60 serious adverse events were reported in 58 participants (14 in three-dose group, 26 in two-dose group, 18 in one-dose group), mostly infection and infestations or injury, poisoning, and procedural complications. No serious adverse events of special interest or admissions to hospital for dengue occurred. Two deaths occurred, unrelated to study treatment.
INTERPRETATION


A two-dose CYD-TDV regimen might be an alternative to the licensed three-dose regimen in individuals who are dengue seropositive at baseline and aged 9 years and older. Vaccination with a reduced number of doses could lead to improved vaccine compliance and coverage, especially in low-resource settings.
FUNDING


Sanofi Pasteur.",2020,Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed:,"['Between May 2, 2016, and Sept 16, 2016, we recruited and enrolled 1050 individuals, of whom 1048 received at least one injection and 993 had at least one blood sample taken (full-analysis dataset; 333 in three-dose group, 328 in two-dose group, and 332 in one-dose group', 'healthy individuals aged 9-50 years were recruited from the community in three sites in Colombia and three sites in the Philippines', 'individuals who are dengue seropositive at baseline and aged 9 years and older', 'participants who had been vaccinated, had no protocol deviations, and had a valid serology test result for at least one dengue serotype at 28 days after the third injection', 'individuals aged 9 years and older who are dengue seropositive', 'healthy individuals aged 9-50 years (CYD65', '860 (86·6%) of 993 participants in the full-analysis dataset were dengue seropositive at baseline']","['CYD-TDV', 'placebo']","['Immunogenicity and safety', 'geometric mean titres (GMTs) of neutralising antibodies against each dengue virus serotype', 'Safety', 'neutralising antibody GMTs', 'mostly infection and infestations or injury, poisoning, and procedural complications', 'Reactogenicity profiles']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0443225', 'cui_str': 'Full'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0011311', 'cui_str': 'Dengue'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.361198,Non-inferiority (two dose vs three dose) was shown for each serotype at both 28 days and 1 year among dengue-seropositive participants (number of participants assessed:,"[{'ForeName': 'Diana Leticia', 'Initials': 'DL', 'LastName': 'Coronel-MartÍnez', 'Affiliation': 'Sanofi Pasteur, Santa Catarina, Coyoacán, Mexico City, Mexico. Electronic address: dianaLeticia.coronel@sanofi.com.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Sanofi Pasteur, Singapore.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'López-Medina', 'Affiliation': 'Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Médico Imbanaco, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'María Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Filinvest Corporate City, Alabang, Muntinlupa, Metro Manila, Philippines.'}, {'ForeName': 'Andrés Angelo', 'Initials': 'AA', 'LastName': 'Cadena Bonfanti', 'Affiliation': 'Clinica de la Costa, Barranquilla, Atlántico, Colombia.'}, {'ForeName': 'María Cecilia', 'Initials': 'MC', 'LastName': 'Montalbán', 'Affiliation': 'Manila Doctors Hospital, Ermita, Metro Manila, Philippines.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ramírez', 'Affiliation': 'Infectious Diseases, Internal Medicine, Hospital Pablo Tobón Uribe, Universidad de Antioquia, Medellín, Antioquia, Colombia.'}, {'ForeName': 'María Liza Antoinette', 'Initials': 'MLA', 'LastName': 'Gonzales', 'Affiliation': 'University of the Philippines Manila-Philippine General Hospital, Ermita, Metro Manila, Philippines.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'DiazGranados', 'Affiliation': ""Sanofi Pasteur, Swiftwater, PA, USA; Sanofi Pasteur, Marcy L'Etoile, France.""}, {'ForeName': 'Betzana', 'Initials': 'B', 'LastName': 'Zambrano', 'Affiliation': 'Sanofi Pasteur, Montevideo, Uruguay.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Dayan', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Savarino', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Sanofi Pasteur, Chaoyang, Beijing, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bonaparte', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Rojas', 'Affiliation': 'Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Jenny Carolina', 'Initials': 'JC', 'LastName': 'Ramírez', 'Affiliation': 'Sanofi Pasteur, Bogotá, Colombia.'}, {'ForeName': 'Mae Ann', 'Initials': 'MA', 'LastName': 'Verdan', 'Affiliation': 'Sanofi Pasteur, Taguig, Metro Manila, Philippines.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Noriega', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30767-2']
2436,33209773,"Adiposity contributes to poor glycemic control in people with diabetes mellitus, a randomized case study, in South Kashmir, India.","Background


Diabetes mellitus (DM) is a significant health burden and recent reports suggest that the incidence of diabetes is increasing. Poor knowledge, fear of use of new drugs, and lack of awareness of the importance of the control of the disease are common among primary care physicians caring for diabetes patients. Many diabetes patients continue to be underdiagnosed, undertreated, increased use of expensive acute health-care services, and reduced quality of life.
Aims and Objectives


The aim was to study the poor control of DM and the associated risk factors associated with Type 2 DM, to spread awareness about DM, to assess the prevalence, treatment, and control of diabetes, to examine the relationship of obesity with raised blood glucose, and finally, to evaluate the effect of the educational level on glycemic control.
Study Material


This study was conducted to evaluate the control of diabetes in South Kashmir, India. It was done among patients in the Outpatient Department of Medicine, MMAB Memorial Hospital (GMC Associated Hospital) Anantnag, Kashmir. A random sampling procedure was adopted for the study, and a total of 300 patients were studied over a period of 5 months, which included 155 men and 145 women. During a period of study, within the age group of 36-50 years with adiposity were assessed for glycemic control.
Methodology


All patients underwent anthropometric assessment and blood pressure measurements. Fasting blood sample was obtained for plasma glucose and lipids. Patients were assessed for weight and body mass index.
Results


The prevalence of uncontrolled glycemia was more frequent in women as compared to men because of adiposity.",2020,"Poor knowledge, fear of use of new drugs, and lack of awareness of the importance of the control of the disease are common among primary care physicians caring for diabetes patients.","['people with diabetes mellitus', 'primary care physicians caring for diabetes patients', 'patients in the Outpatient Department of Medicine, MMAB Memorial Hospital (GMC Associated Hospital', 'diabetes in South Kashmir, India', '300 patients were studied over a period of 5 months, which included 155 men and 145 women', '\n\n\nDiabetes mellitus (DM']",[],"['Fasting blood sample', 'weight and body mass index', 'uncontrolled glycemia', 'blood pressure measurements']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",300.0,0.0255783,"Poor knowledge, fear of use of new drugs, and lack of awareness of the importance of the control of the disease are common among primary care physicians caring for diabetes patients.","[{'ForeName': 'Gowher Ahmad', 'Initials': 'GA', 'LastName': 'Wagai', 'Affiliation': 'Consulting Physician-Diabetologist, Department of Medicine, Associated Hospital GMC, Anantnag, Jammu and Kashmir, India.'}, {'ForeName': 'Ghulam Jeelani', 'Initials': 'GJ', 'LastName': 'Romshoo', 'Affiliation': 'Professor and HOD, Department of Medicine, GMC, Anantnag, Jammu and Kashmir, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_1148_19']
2437,33209783,A study on effectiveness of video assisted counselling in establishing and sustaining appropriate breast feeding practices.,"Background and Aims


Breast milk is the only food for the neonate with vast benefits. Although breastfeeding process is natural but extensive research has revealed that mother requires active support for establishing and sustaining appropriate breast feeding practices. Due to high patient load, effective counselling of all pregnant ladies becomes a huge task. Video-assisted counselling has been tried for establishing and sustaining breastfeeding practices as it helps mothers to understand the procedure and process better as the video image is animated with a narrative voice. The objective is to study the effectiveness of video assisted breast feeding counselling in establishing and sustaining breast feeding practices.
Materials and Methods


A Quasi experimental study was done in Obstetrics and Gynaecology department of BRD Medical College Gorakhpur from September 2019 to February 2020. Study subjects were pregnant ladies admitted in labour room for delivery. A total of 60 study subjects were allocated in Video-assisted breast feeding counselling group and same number in routine counselling group. Video-assisted counselling group breast feeding counselling was done with use of two videos (Video 1 is of 5 minute and 34 seconds duration and Video 2 is of 2 minutes and 50 seconds duration) demonstrations in labour room and post natal ward. Routine breast feeding counselling group received routine counselling as done by resident or consultants during their care. After the delivery the study participants were interviewed regarding their profile and breast feeding knowledge, motivation and behaviour and a scoring was done with Min. -0 to Max. 20 score.
Result


Higher proportion of early initiation of breast feeding was observed in the video assisted counselling group as compared with the routine counselling group. The mean knowledge score of the subjects' video-assisted counselling group the mean knowledge score was significantly higher. Motivation of mother for breast feeding and improvement in their behaviour and skill in video-assisted counselling group was higher in comparison to routine counselling group.
Conclusion


Video-assisted counselling was found effective in successful initiation and establishment of breast feeding.",2020,"Result


Higher proportion of early initiation of breast feeding was observed in the video assisted counselling group as compared with the routine counselling group.","['A total of 60 study subjects', 'Obstetrics and Gynaecology department of BRD Medical College Gorakhpur from September 2019 to February 2020', 'Study subjects were pregnant ladies admitted in labour room for delivery']","['Video-assisted breast feeding counselling group and same number in routine counselling group', 'Routine breast feeding counselling group received routine counselling', 'Video-assisted counselling group breast feeding counselling', 'Video-assisted counselling', 'video assisted breast feeding counselling', 'video assisted counselling']","['early initiation of breast feeding', 'mean knowledge score', 'successful initiation and establishment of breast feeding']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",60.0,0.0368854,"Result


Higher proportion of early initiation of breast feeding was observed in the video assisted counselling group as compared with the routine counselling group.","[{'ForeName': 'Vani', 'Initials': 'V', 'LastName': 'Aditya', 'Affiliation': 'Professor & Head, Department of Obstetrics & Gynecology, BRD Medical College, Gorakhpur, Uttar Pradesh, India.'}, {'ForeName': 'Harish Chandra', 'Initials': 'HC', 'LastName': 'Tiwari', 'Affiliation': 'Assistant Professor- Health Education, Department of Obstetrics & Gynecology,BRD Medical College, Gorakhpur, Uttar Pradesh, India.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Mishra', 'Affiliation': 'Assistant Professor- Epidemiology, Department of Community Medicine, MLN Medical College, Prayagraj, Uttar Pradesh, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_622_20']
2438,33209804,Flipped classroom versus traditional lecture in training undergraduates in pediatric epilepsy.,"Introduction


Pedagogical constructs such as flipped classroom are used to engage students in the learning process by their active participation. The aim of the present study was to compare the two models of flipped classroom and traditional lecture in training undergraduates in pediatric epilepsy.
Methods


The study was conducted among the 3 rd -year undergraduate medical students. They were divided to either of Group I or II. Pediatric epilepsy was taught in two parts (clinical diagnosis and management). Group I received Part A as traditional lecture and Part B as the flipped classroom and the reverse for Group II. The difference in posttest and pretest scores was compared between two groups for each part.
Results


There was a significant increase in posttest scores when compared to pretest scores in both the groups. Mean (standard deviation [SD]) difference in scores for epilepsy diagnosis was comparable in Group I (3.33 [2.3]) and Group II (2.46 [2.17]) ( P  = 0.16). Mean (SD) difference in scores for epilepsy management was significantly higher in Group I (3.41 [2.09]) when compared to Group II (1.30 [1.84]) ( P  < 0.01).
Conclusion


Flipped classroom model resulted in better scores than the traditional teaching method for training undergraduates in the management of epilepsy in children. This teaching-learning method could be adopted in training of primary care physicians.",2020,"Conclusion


Flipped classroom model resulted in better scores than the traditional teaching method for training undergraduates in the management of epilepsy in children.","['children', 'training undergraduates in pediatric epilepsy', '3 rd -year undergraduate medical students']","['Flipped classroom versus traditional lecture', 'flipped classroom and traditional lecture', 'Part A as traditional lecture and Part B as the flipped classroom and the reverse for Group II']","['Mean (SD) difference in scores for epilepsy management', 'posttest scores', 'Mean (standard deviation [SD]) difference in scores for epilepsy diagnosis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.0150171,"Conclusion


Flipped classroom model resulted in better scores than the traditional teaching method for training undergraduates in the management of epilepsy in children.","[{'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Arya', 'Affiliation': 'Department of Pediatrics, Pt. BD Sharma PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Virender Kumar', 'Initials': 'VK', 'LastName': 'Gehlawat', 'Affiliation': 'Department of Pediatrics, Pt. BD Sharma PGIMS, Rohtak, Haryana, India.'}, {'ForeName': 'Radhamohan', 'Initials': 'R', 'LastName': 'Rana', 'Affiliation': 'Department of Pediatrics, BPS Government Medical College for Women, Khanpur Kalan, Sonepat, Haryana, India.'}, {'ForeName': 'Jayashankar', 'Initials': 'J', 'LastName': 'Kaushik', 'Affiliation': 'Department of Pediatrics, Pt. BD Sharma PGIMS, Rohtak, Haryana, India.'}]",Journal of family medicine and primary care,['10.4103/jfmpc.jfmpc_816_20']
2439,33210016,"Baseline characteristics and age-related macular degeneration in participants of the ""ASPirin in Reducing Events in the Elderly"" (ASPREE)-AMD trial.","Purpose


To describe the baseline participant characteristics in the ASPREE-AMD study, investigating the effect of aspirin on AMD incidence and progression.
Methods


Australian participants from the ASPirin in Reducing Events in the Elderly (ASPREE) trial, randomized to 100 mg aspirin daily or placebo, had non-mydriatic, digital color fundus images graded according to the Beckman AMD classification. Associations with AMD were determined for baseline characteristics and genetic risk variants.
Results


ASPREE-AMD sub-study enrolled 4993 participants with gradable macular images. Median age was 73.4 years (IQR, 71.5, 76.6), 52% were female, 10% had diabetes mellitus, 73% had hypertension, and 44% were former/current smokers. Early, intermediate and late AMD (detected in 20.6%, 16.1%, 1.1%, respectively), significantly associated with age, were also associated with increasing HDL levels: OR = 1.52 (95%CI, 1.26, 1.84), OR = 1.43 (1.17, 1.77) and OR = 1.96 (1.02, 3.76), respectively. Female sex was associated with early [OR = 1.37 (1.16, 1.62)], and intermediate [OR = 1.35 (1.12, 1.63)] AMD, as was previous regular use of aspirin, with OR = 1.46 (1.11, 1.92) and OR = 1.37 (1.01, 1.85), respectively. Current smoking had increased odds for late AMD, OR = 4.02 (1.42, 11.36). Genetic risk variant rs3750846 ( ARMS2/HTRA1 ) was associated with each AMD stage ( p  < 0.001), risk variants rs570618 and rs10922109 ( CFH)  with intermediate and late AMD ( p  < 0.001), and rare variant rs147859257 ( C3 ) with late AMD ( p  < 0.001). The randomized groups were well balanced for all analyzed AMD risk factors.
Conclusions


Observed associations are typical of AMD. The ASPREE-AMD clinical trial provides a unique opportunity to determine the risks and benefits of low-dose aspirin for AMD incidence and progression in elderly population.
Trial registration


Australian New Zealand Clinical Trial Registry: ACTRN 12613000755730.",2020,"Current smoking had increased odds for late AMD, OR = ","['Female sex was associated with early [OR\xa0', '4993 participants with gradable macular images', 'Median age was 73.4 years (IQR, 71.5, 76.6), 52% were female, 10% had diabetes mellitus, 73% had hypertension, and 44% were former/current smokers']","['aspirin daily or placebo', 'ASPirin', 'aspirin']","['AMD incidence and progression', 'intermediate and late AMD']","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",4993.0,0.0965807,"Current smoking had increased odds for late AMD, OR = ","[{'ForeName': 'Liubov D', 'Initials': 'LD', 'LastName': 'Robman', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Le Thi', 'Initials': 'LT', 'LastName': 'Phuong Thao', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Lauren Ab', 'Initials': 'LA', 'LastName': 'Hodgson', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Phung', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Galina A', 'Initials': 'GA', 'LastName': 'Makeyeva', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Department of Surgery (Ophthalmology), University of Melbourne, 32 Gisborne Street, East Melbourne, VIC, 3002, Australia.'}, {'ForeName': 'Y-Anh', 'Initials': 'YA', 'LastName': 'Le-Pham', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Jewhara', 'Initials': 'J', 'LastName': 'Suleiman', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Maguire', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Trevaks', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Riaz', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lacaze', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Walter P', 'Initials': 'WP', 'LastName': 'Abhayaratna', 'Affiliation': 'College of Health and Medicine, The Australian National University, Canberra, ACT, 0200, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, 7000, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, Department of Family Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA, 52242, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre 99 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100667']
2440,32358566,"Clinical presentation and differential splicing of SRSF2, U2AF1 and SF3B1 mutations in patients with acute myeloid leukemia.","Previous studies demonstrated that splicing factor mutations are recurrent events in hematopoietic malignancies with both clinical and functional implications. However, their aberrant splicing patterns in acute myeloid leukemia remain largely unexplored. In this study, we characterized mutations in SRSF2, U2AF1, and SF3B1, the most commonly mutated splicing factors. In our clinical analysis of 2678 patients, splicing factor mutations showed inferior relapse-free and overall survival, however, these mutations did not represent independent prognostic markers. RNA-sequencing of 246 and independent validation in 177 patients revealed an isoform expression profile which is highly characteristic for each individual mutation, with several isoforms showing a strong dysregulation. By establishing a custom differential splice junction usage pipeline, we accurately detected aberrant splicing in splicing factor mutated samples. A large proportion of differentially used junctions were novel, including several junctions in leukemia-associated genes. In SRSF2(P95H) mutants, we further explored the possibility of a cascading effect through the dysregulation of the splicing pathway. Furthermore, we observed a validated impact on overall survival for two junctions overused in SRSF2(P95H) mutants. We conclude that splicing factor mutations do not represent independent prognostic markers. However, they do have genome-wide consequences on gene splicing leading to dysregulated isoform expression of several genes.",2020,"RNA-sequencing of 246 and independent validation in 177 patients revealed an isoform expression profile which is highly characteristic for each individual mutation, with several isoforms showing a strong dysregulation.","['177 patients', 'patients with acute myeloid leukemia']",[],"['inferior relapse-free and overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",2678.0,0.0380035,"RNA-sequencing of 246 and independent validation in 177 patients revealed an isoform expression profile which is highly characteristic for each individual mutation, with several isoforms showing a strong dysregulation.","[{'ForeName': 'Stefanos A', 'Initials': 'SA', 'LastName': 'Bamopoulos', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany. stefanos.bamopoulos@charite.de.'}, {'ForeName': 'Aarif M N', 'Initials': 'AMN', 'LastName': 'Batcha', 'Affiliation': 'Institute for Medical Information Processing Biometry and Epidemiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Vindi', 'Initials': 'V', 'LastName': 'Jurinovic', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Rothenberg-Thurley', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Janke', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Ksienzyk', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Philippou-Massier', 'Affiliation': 'Laboratory for Functional Genome Analysis (LAFUGA), Gene Center, LMU Munich, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Graf', 'Affiliation': 'Laboratory for Functional Genome Analysis (LAFUGA), Gene Center, LMU Munich, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krebs', 'Affiliation': 'Laboratory for Functional Genome Analysis (LAFUGA), Gene Center, LMU Munich, Munich, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Blum', 'Affiliation': 'Laboratory for Functional Genome Analysis (LAFUGA), Gene Center, LMU Munich, Munich, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Konstandin', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Sauerland', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Görlich', 'Affiliation': 'Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.'}, {'ForeName': 'Wolfgang E', 'Initials': 'WE', 'LastName': 'Berdel', 'Affiliation': 'Department of Medicine, Hematology and Oncology, University of Münster, Münster, Germany.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Woermann', 'Affiliation': 'German Society of Hematology and Oncology, Berlin, Germany.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'Bohlander', 'Affiliation': 'Leukemia and Blood Cancer Research Unit, Department of Molecular Medicine and Pathology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Canzar', 'Affiliation': 'Gene Center, LMU Munich, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Information Processing Biometry and Epidemiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Braess', 'Affiliation': 'Department of Oncology and Hematology, Hospital Barmherzige Brüder, Regensburg, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Spiekermann', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Klaus H', 'Initials': 'KH', 'LastName': 'Metzeler', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Herold', 'Affiliation': 'Laboratory for Leukemia Diagnostics, Department of Medicine III, University Hospital, LMU Munich, Munich, Germany. tobias.herold@med.uni-muenchen.de.'}]",Leukemia,['10.1038/s41375-020-0839-4']
2441,32574505,Novel Therapeutic Approaches for Pulmonary Manifestations of Systemic Sclerosis.,,2020,,[],[],[],[],[],[],,0.0294542,,"[{'ForeName': 'Justin K', 'Initials': 'JK', 'LastName': 'Lui', 'Affiliation': 'Section of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Bosch', 'Affiliation': 'Section of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Kari R', 'Initials': 'KR', 'LastName': 'Gillmeyer', 'Affiliation': 'Section of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Christine C', 'Initials': 'CC', 'LastName': 'Reardon', 'Affiliation': 'Section of Pulmonary, Allergy, Sleep and Critical Care Medicine, Boston University School of Medicine, Boston, Massachusetts.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202002-0307RR']
2442,28974127,A Signature of Attention-Elicited Electrocortical Activity Distinguishes Response From Non-Response to the Non-Stimulant Atomoxetine in Children and Adolescents With ADHD.,"OBJECTIVE


Atomoxetine has several characteristics that make it an attractive alternative to stimulants for treating ADHD, but there are currently no tests identifying individuals for whom the medication should be a first-line option.
METHOD


Within the ADHD Controlled Trial Investigation Of a Non-stimulant (ACTION) study, we examined neuro-cortical activity in 52 youth with ADHD. Baseline event-related potentials (ERP) were compared between those who subsequently responded to 6 weeks of atomoxetine versus those who did not.
RESULTS


Responders were distinguished by significantly lower auditory oddball N2 amplitudes than both non-responders and typically developing controls, particularly in the right frontocentral region ( p = .002, Cohen's d = 1.1). Leave-one-out cross validation determined that N2 amplitude in this region was able to accurately predict non-responders with a specificity of 80.8%. There were no P3 differences between responders and non-responders.
CONCLUSION


The N2 amplitude is a biomarker that may have utility in predicting response to atomoxetine for youth with ADHD.",2019,"RESULTS


Responders were distinguished by significantly lower auditory oddball N2 amplitudes than both non-responders and typically developing controls, particularly in the right frontocentral region ( p = .002, Cohen's d = 1.1).","['Children and Adolescents With ADHD', '52 youth with ADHD']","['atomoxetine', 'Atomoxetine']","['Baseline event-related potentials (ERP', 'auditory oddball N2 amplitudes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",52.0,0.0235197,"RESULTS


Responders were distinguished by significantly lower auditory oddball N2 amplitudes than both non-responders and typically developing controls, particularly in the right frontocentral region ( p = .002, Cohen's d = 1.1).","[{'ForeName': 'Kristi R', 'Initials': 'KR', 'LastName': 'Griffiths', 'Affiliation': '1 Brain Dynamics Centre, The Westmead Institue for Medical Research, The University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Barbora G', 'Initials': 'BG', 'LastName': 'Jurigova', 'Affiliation': '1 Brain Dynamics Centre, The Westmead Institue for Medical Research, The University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Leikauf', 'Affiliation': '2 Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': '3 Brain Resource, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Clarke', 'Affiliation': '1 Brain Dynamics Centre, The Westmead Institue for Medical Research, The University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Tracey W', 'Initials': 'TW', 'LastName': 'Tsang', 'Affiliation': '1 Brain Dynamics Centre, The Westmead Institue for Medical Research, The University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Erdahl T', 'Initials': 'ET', 'LastName': 'Teber', 'Affiliation': ""7 Children's Medical Research Institute, Westmead, New South Wales, Australia.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kohn', 'Affiliation': '1 Brain Dynamics Centre, The Westmead Institue for Medical Research, The University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': '2 Psychiatry and Behavioral Sciences, Stanford University, Palo Alto, CA, USA.'}]",Journal of attention disorders,['10.1177/1087054717733044']
2443,31141275,Influence of hyper-harmonized fullerene water complex on collagen quality and skin function.,"BACKGROUND


Fullerene water complex establishes the optimal order and function of biomolecules in natural, biophysical way by transducing the signal through water hydrogen bonds to biomolecules.
OBJECTIVES


This paper considers the effects of the patented hyper-harmonized-hydroxylated fullerene water complex (3HFWC) on biophysical properties of the skin collagen molecules.
METHOD


Optomagnetic imaging spectroscopy (OMIS) has been used for the analysis of the biophysical skin properties (diamagnetic/paramagnetic) after applying three groups of different cosmetic products. Tested cosmetic products were prepared by replacing the active ingredients with 3HFWC or with water in four commercial products. The original commercial creams and their vehiculums with water added served as control groups. Data were statistically analyzed using paired t test in R software.
RESULTS


t Test gave statistically significant results for all of the products with 3HFWC, while within the control group, only body lotion and hand cream did show statistically significant results (P < 0.05). Significant improvements in abundance and quality of collagen in the dermis were achieved with body lotion with 3HFWC (p +  /p -  ranged from 0.82 to 0.97). While body lotion vehiculum made collagen-water interaction more stable (p +  /p -  ranged from 0.3 to 0.55), hand cream with 3HFWC made it more dynamic (p +  /p -  ranged from 0.63 to 0.49). Body lotion vehiculum improved the compactness of the dermis (p +  /p -  ranged from 0.2 to 1.03), as well as commercial hand cream (p +  /p -  ranged from 0.28 to 0.85).
CONCLUSION


Compared to the control groups, cosmetic products with 3HFWC demonstrated positive effects on the biophysical properties of the skin. Increased paramagnetic properties are linked to more unpaired electrons, their faster movement, and, finally, better signal transduction. Thus, products with 3HFWC could enable faster regeneration of collagen and prompt skin reaction to the negative environmental influences.",2020,"Body lotion vehiculum improved the compactness of the dermis (p +  /p -  ranged from 0.2 to 1.03), as well as commercial hand cream (p +  /p -  ranged from 0.28 to 0.85).
",[],['patented hyper-harmonized-hydroxylated fullerene water complex (3HFWC'],"['abundance and quality of collagen', 'collagen quality and skin function', 'compactness of the dermis']",[],"[{'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0302934', 'cui_str': 'Fullerene'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0037289', 'cui_str': 'Skin function'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}]",,0.0171796,"Body lotion vehiculum improved the compactness of the dermis (p +  /p -  ranged from 0.2 to 1.03), as well as commercial hand cream (p +  /p -  ranged from 0.28 to 0.85).
","[{'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Miljkovic', 'Affiliation': 'TFT Nano Center, Belgrade, Serbia.'}, {'ForeName': 'Branislava', 'Initials': 'B', 'LastName': 'Jeftic', 'Affiliation': 'Faculty of Mechanical Engineering, Department of Biomedical Engineering, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Sarac', 'Affiliation': 'Faculty of Mechanical Engineering, Department of Biomedical Engineering, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Matovic', 'Affiliation': 'Faculty of Mechanical Engineering, Department of Biomedical Engineering, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Slavkovic', 'Affiliation': 'TFT Nano Center, Belgrade, Serbia.'}, {'ForeName': 'Djuro', 'Initials': 'D', 'LastName': 'Koruga', 'Affiliation': 'TFT Nano Center, Belgrade, Serbia.'}]",Journal of cosmetic dermatology,['10.1111/jocd.12999']
2444,31208259,Impact of an educational digital storytelling intervention on HIV risk perception among Nigerian adolescents.,,2020,,['Nigerian adolescents'],['educational digital storytelling intervention'],['HIV risk perception'],"[{'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0193698,,"[{'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'Department of Arts Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Mkpoikanke Sunday', 'Initials': 'MS', 'LastName': 'Otu', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Ibenegbu', 'Initials': 'I', 'LastName': 'Christopher', 'Affiliation': 'Department of Arts Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Asogwa', 'Initials': 'A', 'LastName': 'Uche', 'Affiliation': 'Department of Arts Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Linus Okechukwu', 'Initials': 'LO', 'LastName': 'Nwabuko', 'Affiliation': 'Department of Adult Education and Extra Moral Studies, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Ibe', 'Initials': 'I', 'LastName': 'Ebere', 'Affiliation': 'Department of Science Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Ibiwari Caroline', 'Initials': 'IC', 'LastName': 'Dike', 'Affiliation': 'Department of Educational Foundations (Childhood Education), University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Obiyo', 'Initials': 'O', 'LastName': 'Ngozi', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Uwakwe', 'Initials': 'U', 'LastName': 'Chinedozie', 'Affiliation': 'Department of Arts Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Abdullahi', 'Initials': 'A', 'LastName': 'Muhammed', 'Affiliation': 'Department of Arts Education, University of Nigeria, Nsukka, Nigeria.'}]",The Journal of international medical research,['10.1177/0300060519854635']
2445,31215156,Clinical evaluation of the safety and efficacy of a timosaponin A-III-based antiwrinkle agent against skin aging.,"BACKGROUND


Timosaponin A-III (TA-III) is known to exist in the medicinal herb of Anemarrhena asphodeloides as one of major chemical components.
AIMS


The photoprotective properties of TA-III on UVB-exposed HaCaT cells were evaluated on the antiwrinkle effects and skin safety in terms of clinical trial.
METHODS


The level of matrix metalloproteinase (MMP)-1, tissue inhibitor of metalloproteinases (TIMPs), and pro-inflammatory cytokines were measured in HaCaT cells following UVB irradiation. To evaluate the clinical safety of an agent containing 0.25% of TA-III for use on human skin. Female subjects (n = 21) between the ages of 43 and 55 who met the criteria for subject selection were selected. They were beginning to form or had already formed wrinkles.
RESULTS


UVB irradiation increased MMP-1 expression and pro-inflammatory cytokines. These increases were attenuated by TA-III pretreatment of UVB-exposed HaCaT cells. We found that the agent containing 0.25% of TA-III ameliorated skin wrinkling. A comparison between groups showed that wrinkle parameters were significantly reduced after 12 weeks of product use (P < 0.05). According to skin safety result, TA-III showed no dermatological toxicity was found in participants.
CONCLUSIONS


In conclusion, TA-III could provide protection against photoaging and daily application of TA-III for 12 weeks significantly reduced signs of facial aging by limiting wrinkle formation.",2020,A comparison between groups showed that wrinkle parameters were significantly reduced after 12 weeks of product use (P < 0.05).,"['Female subjects (n\xa0=\xa021) between the ages of 43 and 55 who met the criteria for subject selection were selected', 'human skin']",['timosaponin A-III-based antiwrinkle agent against skin aging'],"['MMP-1 expression and pro-inflammatory cytokines', 'level of matrix metalloproteinase (MMP)-1, tissue inhibitor of metalloproteinases (TIMPs), and pro-inflammatory cytokines', 'wrinkle parameters', 'dermatological toxicity', 'antiwrinkle effects and skin safety']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0949543', 'cui_str': 'Selection of Subjects'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0127082', 'cui_str': 'Interstitial Collagenase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0215071,A comparison between groups showed that wrinkle parameters were significantly reduced after 12 weeks of product use (P < 0.05).,"[{'ForeName': 'A-Rang', 'Initials': 'AR', 'LastName': 'Im', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.'}, {'ForeName': 'Young Kyoung', 'Initials': 'YK', 'LastName': 'Seo', 'Affiliation': 'Dermapro, Safety and Efficacy Evaluation of Cosmetics & Cosmeceuticals, Seoul, Korea.'}, {'ForeName': 'Se Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'H&A Pharmachem, Bucheon-si, Korea.'}, {'ForeName': 'Kyeong Hee', 'Initials': 'KH', 'LastName': 'O', 'Affiliation': 'HansolBio, Seongnam-si, Korea.'}, {'ForeName': 'Ki Mo', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.'}, {'ForeName': 'Sungwook', 'Initials': 'S', 'LastName': 'Chae', 'Affiliation': 'Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13035']
2446,31353988,Intervention for depression among chemistry education undergraduates in a Nigerian university.,,2020,,['chemistry education undergraduates in a Nigerian university'],[],[],"[{'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0041740', 'cui_str': 'University'}]",[],[],,0.0322496,,"[{'ForeName': 'Florence Obiageli', 'Initials': 'FO', 'LastName': 'Ezeudu', 'Affiliation': 'Department of Science Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Ngozi M', 'Initials': 'NM', 'LastName': 'Eya', 'Affiliation': 'Department of Science Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Stephen Chinedu', 'Initials': 'SC', 'LastName': 'Nwafor', 'Affiliation': 'Department of Science Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': 'Department of Arts Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}]",The Journal of international medical research,['10.1177/0300060519865064']
2447,31378111,Intervention for burnout among postgraduate chemistry education students.,,2020,,['postgraduate chemistry education students'],[],[],"[{'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.0154142,,"[{'ForeName': 'Florence Obiageli', 'Initials': 'FO', 'LastName': 'Ezeudu', 'Affiliation': 'Department of Science Education, University of Nigeria Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Florence Oboochi', 'Initials': 'FO', 'LastName': 'Attah', 'Affiliation': 'Department of Science Education, University of Nigeria Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Anthonia Ebere', 'Initials': 'AE', 'LastName': 'Onah', 'Affiliation': 'Department of Science Education, University of Nigeria Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Tochukwu Longinus', 'Initials': 'TL', 'LastName': 'Nwangwu', 'Affiliation': 'Department of Educational Foundations, University of Nigeria Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Ekwutosi Monica', 'Initials': 'EM', 'LastName': 'Nnadi', 'Affiliation': 'Department of Arts Education, University of Nigeria Nsukka, Enugu State, Nigeria.'}]",The Journal of international medical research,['10.1177/0300060519866279']
2448,31408237,Assessment of the accuracy of salivary cotinine readings from NicAlert strips against a liquid chromatography tandem mass spectrometry assay in self-reported non-smokers who passed carbon monoxide but failed NicAlert validation.,"BACKGROUND AND AIMS


NicAlert produces semi-quantitative assessments of cotinine levels in saliva or urine for verification of smoking abstinence. This study aimed to assess the accuracy of NicAlert readings against a liquid chromatography tandem mass spectrometry assay in smokers who had passed expired-air carbon monoxide (CO) verification but failed NicAlert verification.
DESIGN


Comparison of NicAlert readings against readings from a reference assay using liquid chromatography tandem mass spectrometry.
SETTING


Geneva, Switzerland.
PARTICIPANTS


Self-reported non-smokers (n = 92) who in previous testing had CO of 0-3 parts per million (indicating no recent smoking) and reported not using any nicotine product, but had NicAlert readings ≥ 1 (indicating smoking).
MEASUREMENTS


NicAlert produces readings of 0, 1 and 2+, which are reported by the manufacturer to correspond to saliva cotinine concentrations of 0-10 ng/ml (indicating not smoking), 10-30 ng/ml and 30+ ng/ml, respectively. Liquid chromatography tandem mass spectrometry was used as the reference.
FINDINGS


For 82 participants with a NicAlert reading of 1, only two of the liquid chromatography tandem mass spectrometry values were within the purported range of 10-30 ng/ml; 71 were below 4 ng/ml and half the values were below 0.5 ng/ml. Two of the eight participants with NicAlert readings of 2 had laboratory values within the designated range. Neither of the two participants with NicAlert readings of 3 had a cotinine value within the designated range.
CONCLUSIONS


In people who had passed carbon monoxide verification, NicAlert readings yielded a very high false-positive rate in detecting levels of cotinine indicative of smoking.",2019,"In people who had passed carbon monoxide verification, NicAlert readings yielded a very high false-positive rate in detecting levels of cotinine indicative of smoking.","['82 participants with a NicAlert reading of 1, only two of the liquid chromatography tandem mass spectrometry values were within the purported range of 10-30\xa0ng/ml; 71 were below 4', 'smokers who had passed expired-air carbon monoxide (CO) verification but failed NicAlert verification', 'Self-reported non-smokers (n\xa0=\xa092) who in previous testing had CO of 0-3 parts per million (indicating no recent smoking) and reported not using any nicotine product, but had NicAlert readings ≥\xa01 (indicating smoking', 'Geneva, Switzerland']",[],"['laboratory values', 'saliva cotinine concentrations']","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",8.0,0.0584819,"In people who had passed carbon monoxide verification, NicAlert readings yielded a very high false-positive rate in detecting levels of cotinine indicative of smoking.","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Etter', 'Affiliation': 'Institute of Global Health, Faculty of Medicine, University of Geneva, Switzerland.'}]","Addiction (Abingdon, England)",['10.1111/add.14775']
2449,31720836,Accommodation response and spherical aberration during orthokeratology.,"PURPOSE


To evaluate the changes in the accommodative response and in the corneal and internal spherical aberration during 3 months of wear of orthokeratology lenses from the baseline.
METHODS


Fifty children aged 8 to 17 were recruited for a prospective study and were fitted with orthokeratology lenses. Refraction without cycloplegia, high and low uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), accommodation lag, horizontal near phoria without correction, corneal topography, corneal, and total wavefront aberration were performed at baseline, 1 day, 1 week, 1 month, and 3 months. Data were analyzed by Student's t test for related samples, repeated measures ANOVA test, and Pearson correlation test.
RESULTS


The spherical equivalent (SE) before and after 3 months was - 3.33 ± 1.60 D and - 0.30 ± 0.46 D, respectively. Accommodation lag was 0.53 ± 0.38 D and 0.20 ± 0.33 D at baseline and at 3 months, respectively. A moderate correlation between lag at the baseline and its change between baseline and the 3-month visit was found (P < 0.05; R = 0.748). The spherical aberration (SA) increased for anterior corneal and total measurement, being statistically significant for all visits (P < 0.05). The internal SA decreased: - 0.105 ± 0.006 at baseline and - 0.196 ± 0.203 at 1 week (P < 0.05). No difference between baseline and the follow-up visits in posterior corneal SA was found (P > 0.05) CONCLUSION: The negative SA of the lens increases during OK treatment compensated for the increase of the anterior corneal surface positive SA, in addition to increasing the accommodative response.",2020,No difference between baseline and the follow-up visits in posterior corneal SA was found (P > 0.05) CONCLUSION:,['Fifty children aged 8 to 17 were recruited for a prospective study and were fitted with orthokeratology lenses'],[],"['posterior corneal SA', 'spherical aberration (SA) increased for anterior corneal and total measurement', 'Refraction without cycloplegia, high and low uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), accommodation lag, horizontal near phoria without correction, corneal topography, corneal, and total wavefront aberration', 'Accommodation response and spherical aberration', 'accommodative response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]",[],"[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1293928', 'cui_str': 'Total measurement'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0235238', 'cui_str': 'Cycloplegia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1637380', 'cui_str': 'Uncorrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1532952', 'cui_str': 'Wavefront aberration'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response'}]",50.0,0.0311078,No difference between baseline and the follow-up visits in posterior corneal SA was found (P > 0.05) CONCLUSION:,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Batres', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peruzzo', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Serramito', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Carracedo', 'Affiliation': 'Department of Optometry and Vision, Faculty of Optics and Optometry, Complutense University of Madrid, C/Arcos del Jalon 118, 28032, Madrid, Spain. jgcarrac@ucm.es.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-019-04504-x']
2450,32036718,Comparative study of the Ambu® AuraOnce™ laryngeal mask and endotracheal intubation in anesthesia airway management during neurosurgery.,,2020,,['anesthesia airway management during neurosurgery'],['Ambu® AuraOnce™ laryngeal mask and endotracheal intubation'],[],"[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]",[],,0.0120677,,"[{'ForeName': 'Qiaoyun', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Baoguo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shuangyan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Mu', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yunxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Intensive Care Unit, Sanbo Brain Hospital, Capital Medical University, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520902606']
2451,33206827,Improving shear bond strength of metallic brackets after whitening.,"OBJECTIVE


To evaluate a protocol for bonding metallic brackets after bleaching with hydrogen peroxide (HP).
METHODS


60 extracted maxillary premolar were randomly divided into an unbleached control group and two groups bleached with a solution of 35% hydrogen peroxide prior to bonding. The teeth in one of the treated groups were bonded immediately after bleaching; while the other group was treated with 10% sodium ascorbate immediately after bleaching and before bonding. The teeth in all groups were stored in an artificial saliva solution for 7 days after bonding. The shear bond strength data was measured in megapascals (MPa) and the fail attempts were verified. The significance level was established at p< 0.05.
RESULTS


The unbleached group, in which brackets were bonded to untreated enamel, had the highest bond strength values (11.0 ± 5.7MPa) in comparison to the bleached group (7.14 ± 40MPa), in which brackets were bonded to recently bleached enamel. Slightly improved bond strength was observed in the antioxidant group (8.13 ± 5.4MPa), in which the teeth were bleached and then the antioxidant was applied to the teeth before bonding. Unbleached and bleached groups showed statistically significant difference for shear bond strength (p=0.03) and load strength (p=0.03); no significant differences were noted between unbleached and antioxidant groups (p=0.52).
CONCLUSION


The antioxidant treatment applied immediately after bleaching was effective in reversing the reduction in shear bond strength of brackets after tooth bleaching.",2020,The antioxidant treatment applied immediately after bleaching was effective in reversing the reduction in shear bond strength of brackets after tooth bleaching.,['60 extracted maxillary premolar'],"['hydrogen peroxide (HP', '10% sodium ascorbate immediately after bleaching and before bonding', 'unbleached control group and two groups bleached with a solution of 35% hydrogen peroxide prior to bonding']","['shear bond strength data', 'load strength', 'shear bond strength', 'bond strength']","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0887557', 'cui_str': 'Sodium Ascorbate'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",60.0,0.0160647,The antioxidant treatment applied immediately after bleaching was effective in reversing the reduction in shear bond strength of brackets after tooth bleaching.,"[{'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Aristizábal', 'Affiliation': 'Universidad del Valle, Department of Orthodontics (Cali, Colombia).'}, {'ForeName': 'Angela Patricia Polanía', 'Initials': 'APP', 'LastName': 'González', 'Affiliation': 'Universidad del Valle, Department of Orthodontics (Cali, Colombia).'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McNamara', 'Affiliation': 'University of Michigan, Department of Orthodontics and Pediatric Dentistry, School of Dentistry (Ann Arbor/MI, USA).'}]",Dental press journal of orthodontics,['10.1590/2177-6709.25.5.038-043.oar']
2452,33206894,Educational intervention to improve the competence of Mexican physicians to provide nutritional management for diabetes mellitus type 2.,"OBJECTIVE


To evaluate the effect of a participative educational intervention on the clinical competence of Mexican family physicians regarding the nutritional management of patients with diabetes mellitus Type 2.
MATERIALS AND METHODS


Quasi-experimental study with a before-and-after control group. Convenience sample included 60 family physicians distributed in two social security primary health care units, randomly selected: 30 in the ""A"" unit and 30 in the ""B"" unit. Unit ""A"" was assigned randomly as control group, and ""B"" unit as intervention group. The intervention consisted of a theoretical-practical course-workshop that lasted six months where real cases were discussed and solved. Clinical competence was evaluated by means of an instrument designed ex professo, with a maximum theoretical value of 100 and 94% reliability according to the Kuder-Richardson test. Medians of clinical competence were compared among groups, before and after intervention, using the Mann-Whitney U test, while frequencies distribution of clinical competence level were analyzed with the Kolmogorov-Smirnov test (p≤0.05).
RESULTS


Overall medians and intervals for unit ""A"" were 28 (9-45) pre-intervention and 34 (11-51) pos-intervention, with before-after difference p>0.05; for unit ""B"", values were 32 (12-50) pre-intervention, 61 (36-82) pos-intervention, and before-after difference p≤0.05. No significant differences were found among groups pre-intervention (p>0.05), although they were observed pos-intervention (p≤0.05).
CONCLUSIONS


The educational intervention evaluated proved to improve, in a statistically significant way, the overall and by dimensions clinical competence level of Mexican family physicians for nutritional management of patients with diabetes mellitus type 2.",2020,"The educational intervention evaluated proved to improve, in a statistically significant way, the overall and by dimensions clinical competence level of Mexican family physicians for nutritional management of patients with diabetes mellitus type 2.","['patients with diabetes mellitus type 2', 'diabetes mellitus type 2', 'Quasi-experimental study with a before-and-after control group', 'Convenience sample included 60 family physicians distributed in two social security primary health care units, randomly selected: 30 in the ""A"" unit and 30 in the ""B"" unit', 'patients with diabetes mellitus']","['participative educational intervention', 'Educational intervention', 'Unit ']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",[],,0.015249,"The educational intervention evaluated proved to improve, in a statistically significant way, the overall and by dimensions clinical competence level of Mexican family physicians for nutritional management of patients with diabetes mellitus type 2.","[{'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Cabrera-Pivaral', 'Affiliation': ""CC: Bachelor's Degree in Medical-Surgical Sciences. Ph.D. Health Siences. Universidad de Guadalajara, University Center for Health Sciences, Discipline Division for Health Development, Promotion and Preservation, Department of Public Health. Guadalajara. Jalisco, México. carlos_cabrera@prodigy.net.mx.""}, {'ForeName': 'René C', 'Initials': 'RC', 'LastName': 'Crocker-Sagástume', 'Affiliation': 'RC: MD. Ph.D. Education. Universidad de Guadalajara, University Center for Health Sciences, Discipline Division of for Health Development, Promotion and Preservation, Department of Public Health. Guadalajara. Jalisco, Mexico. recricrosa_7@hotmail.com.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Zavala-González', 'Affiliation': 'MZ: MD. Ph.D. Public Health Sciences. Universidad de Guadalajara, Tonala University Center, Division of Health Sciences, Department of Population Health Sciences. Tonala. Jalisco, Mexico. zgma_5W83@yahoo.com.mx.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Muñiz-Mendoza', 'Affiliation': ""PM: Bachelor's Degree in Nutrition. Ph.D. Public Health Sciences. Universidad de Guadalajara, University Center for Health Sciences, Discipline Division for Health Development, Promotion and Preservation, Department of Public Health. Guadalajara. Jalisco, Mexico. prismuniz24@gmail.com.""}]","Revista de salud publica (Bogota, Colombia)",['10.15446/rsap.V20n6.65550']
2453,33206937,A validated pediatric disease risk index for allogeneic hematopoietic cell transplantation.,"A disease risk index (DRI) that was developed for adults with hematologic malignancy undergoing hematopoietic cell transplant is also being used to stratify children and adolescents by disease risk. Therefore, in this study, we analyzed 2569 patients aged <18 years with acute myeloid (AML; n=1224) or lymphoblastic (ALL; n=1345) leukemia undergoing hematopoietic cell transplant to develop and validate a DRI that may be used to stratify those with AML and ALL by their disease risk. Training and validation subsets for each disease were generated randomly with 1:1 assignment to the subsets and separate prognostic models were derived for each disease. For AML, four risk groups were identified based on age, cytogenetic risk, and disease status including minimal residual disease status at transplantation. The 5-year leukemia-free survival for low (0 points), intermediate (2, 3, 5), high (7, 8), and very high (>8) risk groups were 78%, 53%, 40%, and 25%, respectively, p<0.0001. For ALL, three risk groups were identified based on age and disease status including minimal residual disease status at transplantation. The 5-year leukemia-free survival for low (0 points), intermediate (2-4), and high (≥5) risk groups were 68%, 51%, and 33%, respectively, p<0.0001. We confirmed the risk groups can be applied for overall survival with 5-year survival ranged from 80% to 33% and 73% to 42% for AML and ALL, respectively (p<0.0001). This validated pediatric DRI that includes age and residual disease status can be used to facilitate prognostication and stratification of children with AML and ALL for allogeneic transplantation.",2020,"We confirmed the risk groups can be applied for overall survival with 5-year survival ranged from 80% to 33% and 73% to 42% for AML and ALL, respectively (p<0.0001).","['allogeneic hematopoietic cell transplantation', 'adults with hematologic malignancy undergoing hematopoietic cell transplant', '2569 patients aged <18 years with acute myeloid (AML; n=1224) or lymphoblastic (ALL; n=1345) leukemia undergoing hematopoietic cell transplant']",[],"['5-year leukemia-free survival', 'overall survival with 5-year survival']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0229613', 'cui_str': 'Lymphoblast'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2569.0,0.0163386,"We confirmed the risk groups can be applied for overall survival with 5-year survival ranged from 80% to 33% and 73% to 42% for AML and ALL, respectively (p<0.0001).","[{'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Qayed', 'Affiliation': 'Childrens Health Care of Atlanta, United States.'}, {'ForeName': 'Kwang Woo', 'Initials': 'KW', 'LastName': 'Ahn', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin, United States.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Kitko', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, United States.'}, {'ForeName': 'Mariam H', 'Initials': 'MH', 'LastName': 'Johnson', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin, United States.'}, {'ForeName': 'Nirali N', 'Initials': 'NN', 'LastName': 'Shah', 'Affiliation': 'Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health (NIH), Bethesda, Maryland, United States.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Dvorak', 'Affiliation': ""University of California San Francisco Children's Hospital, San Francisco, California, United States.""}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Mellgren', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Friend', 'Affiliation': 'Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, Texas, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Verneris', 'Affiliation': 'University of Colorado, Denver, Aurora, Colorado, United States.'}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Leung', 'Affiliation': 'SingHealth Duke-NUS, Singapore, Singapore.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Toporski', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Levine', 'Affiliation': 'Mount Sinai School of Medicine, New York, New York, United States.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Chewning', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, United States.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Wayne', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, California, United States.""}, {'ForeName': 'Urvi', 'Initials': 'U', 'LastName': 'Kapoor', 'Affiliation': 'SUNY Downstate Medical Center, New York, New York, United States.'}, {'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Triplett', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, Tennessee, United States.""}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Schultz', 'Affiliation': 'British Columbia Childrens Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Yanik', 'Affiliation': 'University of Michigan Medical Center, Ann Arbor, Michigan, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Eapen', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin, United States.'}]",Blood,['10.1182/blood.2020009342']
2454,33206991,FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma.,"The FDA approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. The approval was based on efficacy results from a pre-specified interim analysis from the open-label, multi-center, randomized phase 3 CHECKMATE 743 (NCT02899299) trial, designed to evaluate nivolumab plus ipilimumab compared with chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with histologically confirmed unresectable MPM and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy.",2020,The FDA approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.,"['adult patients with unresectable malignant pleural mesothelioma', 'patients with histologically confirmed unresectable MPM and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy']","['FDA Approves Nivolumab Plus Ipilimumab', 'ipilimumab (Yervoy', 'nivolumab plus ipilimumab', 'chemotherapy (pemetrexed and cisplatin or carboplatin']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0661318', 'cui_str': '1-methyl-1-piperidinomethane sulfonate'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C3154308', 'cui_str': 'Yervoy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]",[],,0.048739,The FDA approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wright', 'Affiliation': ''}]","Oncology (Williston Park, N.Y.)",['10.46883/ONC.2020.3411.0502']
2455,33207014,Efficacy of vitamin D supplementation in asthmatic children with vitamin D deficiency: a randomized controlled trial (ESDAC trial).,"BACKGROUND


Vitamin D supplementations for asthma control had shown inconsistent results. We aimed to study efficacy and safety of vitamin D supplementation in asthmatic children who were vitamin D deficient.
METHODS


This double-blind, randomized controlled trial enrolled asthmatic children of 4-12 years of age who had 25-hydroxyvitamin D [25(OH)D] levels < 20 ng/ml. The participants were randomized to receive either vitamin D orally 1000 IU/day for nine months or similar-looking placebo. The primary outcomes were the proportion of children having the Childhood Asthma Control Test (CACT) score of ≥ 20 at the end of the treatment and adverse effects.
RESULTS


The trial included 250 children (125 in each group) with a mean age of 8.1±2.3 years and 180 boys. The baseline parameters were similar between the groups, including CACT score (21.7±4.2 vs 21.9±3.6, vitamin D vs placebo). At the end of the study, the proportion of asthmatic children who had CACT score ≥ 20 was similar between vitamin D and placebo group (93.6% vs 92.0 %, p=0.625). The number of exacerbations of asthma and side effect profile was also identical between the groups. 25(OH)D levels increased significantly in the vitamin D group (18.06±7.11 vs 12.03±5.98 ng/ml, p<0.001). The results did not change when we did subgroup analysis for children with baseline CACT score < 20 and 25(OH)D levels at the end of the study ≥ 20 ng/ml.
CONCLUSION


Vitamin D supplementation in asthmatic children with vitamin D deficiency did not improve control of asthma.",2020,"25(OH)D levels increased significantly in the vitamin D group (18.06±7.11 vs 12.03±5.98 ng/ml, p<0.001).","['enrolled asthmatic children of 4-12 years of age who had 25-hydroxyvitamin D [25(OH)D] levels < 20 ng/ml', 'asthmatic children with vitamin D deficiency', 'asthmatic children who were vitamin D deficient', '250 children (125 in each group) with a mean age of 8.1±2.3 years and 180 boys']","['vitamin D supplementation', 'vitamin D', 'vitamin D and placebo', 'Vitamin D supplementation', 'vitamin D orally 1000 IU/day for nine months or similar-looking placebo']","['CACT score', 'proportion of children having the Childhood Asthma Control Test (CACT) score of ≥ 20 at the end of the treatment and adverse effects', '25(OH)D levels', 'control of asthma', 'number of exacerbations of asthma and side effect profile']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",250.0,0.719372,"25(OH)D levels increased significantly in the vitamin D group (18.06±7.11 vs 12.03±5.98 ng/ml, p<0.001).","[{'ForeName': 'Kana Ram', 'Initials': 'KR', 'LastName': 'Jat', 'Affiliation': 'Department of Pediatrics, New Delhi-10029, India.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Department of Pediatrics, New Delhi-10029, India.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Endocrinology, New Delhi-10029, India.'}, {'ForeName': 'Chandra Prakash', 'Initials': 'CP', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, New Delhi-10029, India.'}, {'ForeName': 'Sudip', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi-10029, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, New Delhi-10029, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, New Delhi-10029, India.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13415']
2456,33207015,Simplified AIT for allergy to several tree pollens - Arguments from the immune outcome analyses following treatment with SQ tree SLIT-tablet.,"BACKGROUND


The SQ tree SLIT-tablet (containing birch extract) proved clinically significant effects during the pollen season for birch as well as alder/hazel. Immune outcomes of this treatment for allergens from multiple birch homologous trees needs further investigation. We hypothesize that birch pollen extract AIT modulate a highly cross-reactive immune response and that this may be the basis for the observed clinical cross-protection.
METHODS


Blood samples were collected from 397 birch allergic patients during SQ tree SLIT-tablet or placebo treatment (1:1) for up to 40 weeks. Serum-IgE and IgG 4  specific to birch, and birch homologous tree pollens from alder, hazel, hornbeam, beech, and chestnut were measured by ImmunoCAP. IgE-Blocking Factor (IgE-BF) for alder, birch, and hazel during treatment were measured by Advia Centaur and blocking effects for birch and all these birch homologous tree pollens were further investigated by basophil activation (BAT). Antibody readouts were investigated in patient subsets. T-cell responses (proliferation) to allergen extracts and peptide pools (group 1 allergens) were investigated in T-cell lines from 29 untreated birch pollen allergic individuals.
RESULTS


Significant Pearson correlations between serum-IgE toward birch, alder, hazel, hornbeam, and beech were observed (r-values>0.86). T-cell reactivity was observed throughout the birch homologous group. Almost identical kinetics for changes in IgE towards birch, alder, and hazel were observed during treatment and similar species-specific changes were seen for serum-IgG 4  . IgG 4  reactivity toward birch and alder, hazel, hornbeam, and beech, correlated significantly at end-of-treatment (r-values>0.72). Treatment resulted in similar IgE-BF kinetics for alder, birch, and hazel and blocking of BAT for multiple trees in most actively treated patients investigated.
CONCLUSIONS


Systematic analyses of T-cell and antibody cross-reactivities before and during birch pollen extract AIT provides the immunological basis for the observed clinical effect of SQ tree SLIT-tablet treatment of tree pollen allergy induced by multiple trees in the birch homologous group.",2020,"Almost identical kinetics for changes in IgE towards birch, alder, and hazel were observed during treatment and similar species-specific changes were seen for serum-IgG 4  .","['treatment (1:1) for up to 40 weeks', 'Blood samples were collected from 397 birch allergic patients during', '29 untreated birch pollen allergic individuals']","['SQ tree SLIT-tablet (containing birch extract', 'IgE-Blocking Factor (IgE-BF', 'SQ tree SLIT-tablet or placebo']","['T-cell reactivity', 'similar IgE-BF kinetics for alder, birch, and hazel and blocking of BAT', 'serum-IgE toward birch, alder, hazel, hornbeam, and beech']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4047367', 'cui_str': 'Birch pollen'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040811', 'cui_str': 'Tree'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0259780', 'cui_str': 'Alder-Reilly body'}, {'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C0330325', 'cui_str': 'Corylus'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1176496', 'cui_str': 'Carpinus'}, {'cui': 'C0936038', 'cui_str': 'Beech'}]",,0.0302678,"Almost identical kinetics for changes in IgE towards birch, alder, and hazel were observed during treatment and similar species-specific changes were seen for serum-IgG 4  .","[{'ForeName': 'Peter Adler', 'Initials': 'PA', 'LastName': 'Würtzen', 'Affiliation': 'ALK, Hoersholm, Denmark.'}, {'ForeName': 'Pernille Milvang', 'Initials': 'PM', 'LastName': 'Grønager', 'Affiliation': 'ALK, Hoersholm, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Lund', 'Affiliation': 'ALK, Hoersholm, Denmark.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'ALK, Hoersholm, Denmark.'}, {'ForeName': 'Peter Sejer', 'Initials': 'PS', 'LastName': 'Andersen', 'Affiliation': 'ALK, Hoersholm, Denmark.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Biedermann', 'Affiliation': 'Department of Dermatology and Allergology, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ipsen', 'Affiliation': 'ALK, Hoersholm, Denmark.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13788']
2457,33212328,"The effectiveness of the Buzzy Ⓡ  device to reduce or prevent pain in children undergoing needle-related procedures: The results from a prospective, open-label, randomised, non-inferiority study.","BACKGROUND


Pain from needle-related procedures in children can alter pain perception, increase pain sensitivity, and generate inappropriate pain responses. Currently pain management includes the use of lidocaine-containing patches, which is complicated to manage in a busy medical setting such as a vaccination centre. We assessed the Buzzy Ⓡ  device, which combines vibration and cold, to manage pain in children undergoing a needle-related procedure, compared to the standard lidocaine patch.
DESIGN


Prospective, open-label, non-inferiority trial.
SETTING


The vaccination centres of three university hospitals in France.
PARTICIPANTS


French speaking children aged 4-15 requiring a needle-related procedure (vaccination or venepuncture) were eligible. Principal exclusion criteria were allergy or sensitivity to the lidocaine patch.
METHODS


Children were randomly allocated (1:1) to use either the Buzzy Ⓡ  device or the lidocaine patch during the needle-related procedure. The lidocaine patch was applied to the puncture site for the hour prior to the intervention. The Buzzy Ⓡ  device was applied to the puncture site for 30 s and then moved 5 cm along the limb during the procedure. The refrigerated wings were detached if they bothered the child. The child assessed their pain using the validated Revised Faces Pain Scale. The revised faces pain scale comprised six facial expressions from 0, normal ""no pain"" to 10, a screaming face ""severe pain"" (2 points/face). The primary endpoint was the average pain score recorded by the child. The study aimed to test the non-inferiority of Buzzy Ⓡ .
RESULTS


Overall 219 participants were randomised. The primary outcome was assessed in 215 children: 108 in the BUZZY group (43% asked for the refrigerated wings were de to be detatched before the end of the procedure) and 107 in the PATCH group. The baseline characteristics were similar between the study groups with an average age of 9 (range: 4.08-15.81). The average needle-related pain was 2.04 in the BUZZY group and 1.42 in the PATCH group. The average difference between the children's assessments in the groups was 0.62, thus faling to demonstrate non-inferiority.
CONCLUSIONS


Our study failed to show that the Buzzy Ⓡ  device was not inferior to the lidocaine patch in managing pain in children undergoing needle-related procedures. Tweetable abstract: Pain management in children undergoing a needle-related procedure vaccination: which efficacy for Buzzy Ⓡ  device as an alternative to lidocaine patch? A prospective, randomised study.",2020,The average needle-related pain was 2.04 in the BUZZY group and 1.42 in the PATCH group.,"['children undergoing needle-related procedures', 'French speaking children aged 4-15 requiring a needle-related procedure (vaccination or venepuncture) were eligible', 'Children', 'Overall 219 participants were randomised', '215 children: 108 in the BUZZY group (43% asked for the refrigerated wings were de to be detatched before the end of the procedure) and 107 in the PATCH group', 'children undergoing a needle-related procedure', 'The vaccination centres of three university hospitals in France', 'children undergoing a needle-related procedure vaccination']","['lidocaine', 'Buzzy Ⓡ  device or the lidocaine patch', 'Buzzy Ⓡ  device', 'lidocaine patch']","['pain using the validated Revised Faces Pain Scale', 'average pain score', 'pain perception, increase pain sensitivity', 'average needle-related pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",219.0,0.0451208,The average needle-related pain was 2.04 in the BUZZY group and 1.42 in the PATCH group.,"[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Lescop', 'Affiliation': ""CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: katia.lescop@chu-nantes.fr.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Joret', 'Affiliation': ""CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: Isabelle.joret@chu-nantes.fr.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Delbos', 'Affiliation': ""CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: paola.delbos@chu-nantes.fr.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Briend-Godet', 'Affiliation': ""CHU de Nantes, Centre fédératif prévention dépistage, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: valerie.briendgodet@chu-nantes.fr.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Blanchi', 'Affiliation': 'CH le Mans, Centre de Prévention Vaccination et Dépistage, Service des maladies infectieuses et tropicales, 194 Avenue Rubillard, 72037 Le Mans, France. Electronic address: sblanchi@ch-lemans.fr.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brechet', 'Affiliation': 'CHD Vendée, Centre fédératif de prévention et de dépistage, Les Oudairies, 85 925 La Roche sur Yon cedex 9, France. Electronic address: christian.brechet@chd-vendee.fr.'}, {'ForeName': 'Annastasia', 'Initials': 'A', 'LastName': 'Galivel-Voisine', 'Affiliation': ""CHU de Nantes, Direction de la recherche et de l'innovation, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: annastasia.galivelvoisine@chu-nantes.fr.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Coudol', 'Affiliation': ""CHU de Nantes, Clinique des données, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: sandrine.cioudol@chu-nantes.fr.""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Volteau', 'Affiliation': ""CHU de Nantes, Direction de la recherche et de l'innovation, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: christellevolteau@gmail.com.""}, {'ForeName': 'Valéry-Pierre', 'Initials': 'VP', 'LastName': 'Riche', 'Affiliation': ""Service Evaluation Economique et Développement des Produits de Santé, Department of Clinical Research, CHU de Nantes, 5 allée de l'île Gloriette, 44 093 Nantes cedex 1, France. Electronic address: valerypierre.riche@chu-nantes.fr.""}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Cartron', 'Affiliation': 'CHU de Nantes, Direction de la recherche et de l\'innovation, 5 allée de l\'île Gloriette, 44 093 Nantes cedex 1, France; INSERM, SPHERE U1246 ""Methods in Patients-centered Outcomes and Health Research"", Nantes University, Tours University, Nantes, France. Electronic address: emmanuelle.cartron@chu-nantes.fr.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103803']
2458,33212337,Does body appreciation or satisfaction buffer against idealised functionality-focused images of models?,"Research suggests that greater levels of body appreciation and body satisfaction may protect women from negative outcomes when viewing media images of the thin-ideal. In this study, we compared the effectiveness of body appreciation and body satisfaction in ameliorating negative effects from viewing images of the traditional thin-ideal and the newer functional-ideal (i.e., models presented in active stances with a focus on the function of their body). A sample of 122 women (M age  = 24.43 years) from a regional university and the general community was recruited to complete an online study. Participants were randomly allocated to view images of models presented in either an active or posed stance, or images of scenery. Participants completed pre- and post-test measures of appearance and functionality satisfaction, as well as trait measures of body appreciation and satisfaction. Results showed that women had poorer outcomes after viewing the active but not the posed or scenery images. Neither body appreciation nor body satisfaction moderated effects. Active, functional images may be particularly insidious and further research is needed to identify effective protective strategies.",2020,Neither body appreciation nor body satisfaction moderated effects.,['122 women (M age  = 24.43 years) from a regional university and the general community was recruited to complete an online study'],[],"['appearance and functionality satisfaction, as well as trait measures of body appreciation and satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",122.0,0.0320112,Neither body appreciation nor body satisfaction moderated effects.,"[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, Queensland 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Findlay', 'Affiliation': 'University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, Queensland 4558, Australia.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, Queensland 4558, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Halliwell', 'Affiliation': 'Centre for Appearance Research, University of the West of England, UK.'}]",Body image,['10.1016/j.bodyim.2020.09.007']
2459,33207285,Rumination in the Context of Anger and Sadness: Differential Effects on State Agitation.,"BACKGROUND


Agitation is an important transdiagnostic factor for several mental health disorders and a significant risk factor for dangerous or maladaptive coping behaviors. How an individual responds to experiences of agitation itself may also play a crucial role in conferring risk towards maladaptive behaviors. Specifically, ruminating on high arousal emotions, such as anger, will also be more likely to initiate and maintain agitation, thereby increasing risk for impulsive and maladaptive behaviors.
METHODS


Undergraduate students (N=117) were randomly assigned to an emotion induction condition (i.e., control, sadness only, anger only, sadness and anger) followed by either a control condition or a rumination induction. They completed measures on subjective emotional state and agitation at baseline, after emotion induction, after rumination induction, and at the end of session.
RESULTS


Agitation was influenced by negative affect broadly with each experimental condition leading to agitation. Anger influenced momentary change in agitation and sustained agitation when combined with rumination.
LIMITATIONS


The majority of participants in the current study were young, white females and the findings may not generalize to individuals of diverse genders and cultures who may have experience and cope with agitation differently.
CONCLUSIONS


Recognizing and mitigating rumination during moments of anger may help decrease a clients' use of problematic coping behaviors.",2020,"Anger influenced momentary change in agitation and sustained agitation when combined with rumination.
",['Undergraduate students (N=117'],"['emotion induction condition (i.e., control, sadness only, anger only, sadness and anger) followed by either a control condition or a rumination induction']",['subjective emotional state and agitation'],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}]",117.0,0.0661074,"Anger influenced momentary change in agitation and sustained agitation when combined with rumination.
","[{'ForeName': 'Keyne C', 'Initials': 'KC', 'LastName': 'Law', 'Affiliation': 'Seattle Pacific University. Electronic address: Lawk3@spu.edu.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Rogers', 'Affiliation': 'Florida State University; Alpert Medical School of Brown University.'}, {'ForeName': 'Raymond P', 'Initials': 'RP', 'LastName': 'Tucker', 'Affiliation': 'Louisiana State University.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Bauer', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Capron', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Anestis', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Joiner', 'Affiliation': 'Florida State University.'}]",Journal of affective disorders,['10.1016/j.jad.2020.11.071']
2460,33207359,Local Anesthesia Thoracoscopy with versus without Midazolam: A Randomized Controlled Trial.,"BACKGROUND


Medical thoracoscopy is the gold standard for the diagnosis of pleural diseases. To date, no consensus exists regarding the choice of sedative and analgesic agents in patients undergoing local anesthetic thoracoscopy (LAT), and questions are raised as to whether sedatives may add to respiratory side effects.
OBJECTIVE


The aim of the study was to test the hypothesis that administration of midazolam associated with lidocaine versus lidocaine alone in patients with LAT adds to respiratory side effects.
METHODS


We randomly assigned 80 patients to a 1:1 study to 2 groups: local anesthesia by lidocaine (n = 40) versus lidocaine and midazolam (n = 40), with the primary end point being the mean lowest oxygen saturation. The secondary end points were cardiovascular parameters, complications, days of drainage, hospital stay, and patients' quality of life (QoL) as assessed by a visual analog scale (VAS).
RESULTS


The mean age of all patients was 66.6 ± 13.1 years. The study comprised 50 males (62.5%). No difference was observed in the demographics between the 2 groups. No significant difference was observed between the 2 groups in oxygen saturation (primary end point). A significant difference was observed in favor of the midazolam group regarding the QoL assessed by VAS.
CONCLUSION


Midazolam does not add to respiratory side effects when it is used with lidocaine for LAT, while patients' QoL is actually improved in this group. Therefore, in our department, we changed our startegy in favor of the association of lidocaine and midazolam.",2020,No significant difference was observed between the 2 groups in oxygen saturation (primary end point).,"['patients undergoing local anesthetic thoracoscopy (LAT', 'patients with LAT adds to respiratory side effects', '50 males (62.5', 'The mean age of all patients was 66.6 ± 13.1 years']","['Local Anesthesia Thoracoscopy with versus without Midazolam', 'Midazolam', 'lidocaine and midazolam', 'local anesthesia by lidocaine', 'midazolam', 'lidocaine']","['oxygen saturation', ""cardiovascular parameters, complications, days of drainage, hospital stay, and patients' quality of life (QoL) as assessed by a visual analog scale (VAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.0730146,No significant difference was observed between the 2 groups in oxygen saturation (primary end point).,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koulelidis', 'Affiliation': 'Department of Respiratory Medicine, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Anevlavis', 'Affiliation': 'Department of Respiratory Medicine, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Nikitidis', 'Affiliation': 'Department of Anaesthesiology, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Pappas', 'Affiliation': 'Pharmacology, Faculty of Medicine, School of Health Sciences, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Paschalis', 'Initials': 'P', 'LastName': 'Ntolios', 'Affiliation': 'Department of Respiratory Medicine, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.'}, {'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Karkabounas', 'Affiliation': 'Chemistry, School of Sciences, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Boti', 'Affiliation': 'Chemistry, School of Sciences, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Paschalis', 'Initials': 'P', 'LastName': 'Steiropoulos', 'Affiliation': 'Department of Respiratory Medicine, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Karpathiou', 'Affiliation': 'Department of Pathology, North Hospital, University Hospital of Saint Etienne, Saint-Priest-en-Jarez, France.'}, {'ForeName': 'Savvas', 'Initials': 'S', 'LastName': 'Eleftheriadis', 'Affiliation': 'Department of Anaesthesiology, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece.'}, {'ForeName': 'Marios E', 'Initials': 'ME', 'LastName': 'Froudarakis', 'Affiliation': 'Department of Respiratory Medicine, Medical School of Alexandroupolis, Democritus University of Thrace, Alexandroupolis, Greece, mfroud@med.duth.gr.'}]",Respiration; international review of thoracic diseases,['10.1159/000509761']
2461,33207566,Influence of Health Related Fitness on the Morphofunctional Condition of Second Mature Aged Women.,"To analyze the influence of health-related fitness on the condition of second mature aged women. Participants: 65 women divided into two groups. Group 1-40 women, (43.33 ± 0.93) years old and group 2-25 women (44.40 ± 0.93) years old. The participants trained for 8 months, three times a week for 1 h. Group 1 trained dance aerobics (Monday), strength fitness (Wednesday) and stretching (Friday). Group 2 trained only stretching. The body length and mass, handgrip strength test, vital capacity, blood pressure, heart rate, Stange and Genchi tests, and motion amplitude in joints were evaluated before and after the program. The significance of the differences between the groups was evaluated by Student's criterion (t) and Rosenbaum (Q). The different intensity of the health-related effect was confirmed at the end of the program. Physiometric indicators significantly increased in group 1. The complex physical activity led to a decrease in heart rate. The results of the Stange and Genchi tests significantly increased. Goniometric indicators of group 2 increased. The comparative analysis of the participants indicators confirms the generalized and higher health-related effect of the complex fitness program. The effect of such a program showed an increase of the adaptive potential, a significant increase in the functional capabilities of women, and the optimization of the studied indicators. With the same time expenditure for health-related fitness, the complex program has a more multifaceted effect in comparison with stretching.",2020,Physiometric indicators significantly increased in group 1.,"['Participants', 'Second Mature Aged Women', 'second mature aged women', 'Group 1-40 women, (43.33 ± 0.93) years old and group 2-25 women (44.40 ± 0.93) years old', '65 women divided into two groups']","['trained dance aerobics (Monday), strength fitness (Wednesday) and stretching (Friday']","['Physiometric indicators', 'body length and mass, handgrip strength test, vital capacity, blood pressure, heart rate, Stange and Genchi tests, and motion amplitude in joints', 'heart rate']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517486', 'cui_str': '0.93'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0585029', 'cui_str': 'Friday'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0444497', 'cui_str': 'In joint'}]",65.0,0.0204412,Physiometric indicators significantly increased in group 1.,"[{'ForeName': 'Olha', 'Initials': 'O', 'LastName': 'Podrihalo', 'Affiliation': 'Department of Biological Science, Kharkiv State Academy of Physical Culture, 61022 Kharkiv, Ukraine.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Savina', 'Affiliation': 'Department of Dance Sports, Fitness and Gymnastics, Kharkiv State Academy of Physical, 61022 Kharkiv, Ukraine.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Podrigalo', 'Affiliation': 'Department of Medical Science, Kharkiv State Academy of Physical Culture, 61022 Kharkiv, Ukraine.'}, {'ForeName': 'Sergii', 'Initials': 'S', 'LastName': 'Iermakov', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sports, 80-336 Gdansk, Poland.'}, {'ForeName': 'Władysław', 'Initials': 'W', 'LastName': 'Jagiełło', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sports, 80-336 Gdansk, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Rydzik', 'Affiliation': 'Institute of Sport Sciences, University of Physical Education in Krakow, 31-541 Kraków, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Błach', 'Affiliation': 'Department of Sport, University School of Physical Education, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17228465']
2462,33207580,Feasibility of a Tai Chi with Thera-Band Training Program: A Pilot Study.,"Tai Chi, combined with Thera-band (TCTB) exercise may be associated with an improvement in health where it increases physical fitness, improves psychological well-being, and decreases pain. This paper aimed to determine the feasibility of TCTB exercise in older sedentary office workers. Forty office workers aged over 55 years participated in a pilot randomized controlled trial (i.e., 12-week TCTB exercise or Tai Chi exercise only). Feasibility of the TCTB exercise approach was ascertained through the recruitment and enrolment rate, acceptability of the study intervention by participants including retention and adherence rates, participants' learning process, the appropriateness of data collection as well as the participants' evaluation of the intervention. Recruitment took longer than planned, with a low recruitment rate of 2.0% (42/2020), but a high enrolment rate of 95.2% (40/42). Thirty-one participants (i.e., 77.5%) completed the intervention. Of those who completed the trial, the overall average attendance was reported as 85.2%; 84.7% in the TCTB group and 85.7% in the Tai Chi only group. A total of 58.3% of participants ( n  = 21) could independently practice the TCTB or Tai Chi exercise motions at the end of the learning stage. There were no missing data except for the nine participants who withdrew during the intervention. No adverse events or effects were reported, and all participants were satisfied with the 12-week exercise intervention. Results support the feasibility of a large-scale randomized controlled trial to explore the efficacy of a TCTB program for improving health in older sedentary office workers.",2020,A total of 58.3% of participants ( n  = 21) could independently practice the TCTB or Tai Chi exercise motions at the end of the learning stage.,"['older sedentary office workers', 'Forty office workers aged over 55 years']","['TCTB exercise or Tai Chi exercise only', 'Tai Chi with Thera-Band Training Program', 'TCTB program', 'TCTB exercise approach', 'TCTB exercise', 'Tai Chi, combined with Thera-band (TCTB) exercise', 'TCTB']","['TCTB or Tai Chi exercise motions', 'overall average attendance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0874433,A total of 58.3% of participants ( n  = 21) could independently practice the TCTB or Tai Chi exercise motions at the end of the learning stage.,"[{'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'School of Nursing, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'Nathan Campus, Menzies Health Institute Queensland, Griffith University, Brisbane, QLD 4111, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Nathan Campus, Menzies Health Institute Queensland, Griffith University, Brisbane, QLD 4111, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Weeks', 'Affiliation': 'Nathan Campus, Menzies Health Institute Queensland, Griffith University, Brisbane, QLD 4111, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17228462']
2463,33207585,Self-Instruction Video Versus Face-to-Face Instruction of Pharmacy Students' Skills in Blood Pressure Measurement.,"A modern approach to clinical skill education is the use of educational videos, yet there is a shortage of literature investigating the effect of self-instruction videos (SIVs) in pharmacy students. Therefore, our objective was to investigate whether an SIV is non-inferior compared to face-to-face instruction (FTFI) in acquiring blood pressure measurement skills. The participants in this randomized controlled study were pharmacy students. The control group was taught by FTFI, while the intervention group watched an SIV. Before and after the instruction, the participants' performance was assessed by an objective structured clinical examination (OSCE). The participants completed a self-assessment survey before each OSCE session. Moreover, the participants' perception and satisfaction were assessed using another survey. The OSCE score and self-assessment score increased significantly from pre- to post-instruction in both groups. The SIV was non-inferior compared to FTFI in terms of the OSCE score, considering a predefined non-inferiority margin of -10%. The participants' self-assessment yielded inconclusive results for non-inferiority. Both instructional approaches were well received. Considering our findings, SIVs might be a valuable option for teaching pharmacy students' blood pressure measurement skills. However, depending on the skill intended to be taught, a combination of an instructional video with instructor-led teaching may be necessary.",2020,The OSCE score and self-assessment score increased significantly from pre- to post-instruction in both groups.,['pharmacy students'],['Self-Instruction Video Versus Face-to-Face Instruction'],"['objective structured clinical examination (OSCE', 'OSCE score and self-assessment score', 'Blood Pressure Measurement']","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}]",,0.0514562,The OSCE score and self-assessment score increased significantly from pre- to post-instruction in both groups.,"[{'ForeName': 'Samieh', 'Initials': 'S', 'LastName': 'Farahani', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Imaneh', 'Initials': 'I', 'LastName': 'Farahani', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Bjoern B', 'Initials': 'BB', 'LastName': 'Burckhardt', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Schwender', 'Affiliation': 'Mathematical Institute, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Laeer', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8040217']
2464,33207604,Combined Exercise Training and l-Glutamine Supplementation Enhances Both Humoral and Cellular Immune Responses after Influenza Virus Vaccination in Elderly Subjects.,"BACKGROUND


Since aging affects the immune responses against vaccination, the present study evaluated the effects of L-glutamine (Gln) supplementation in the humoral and cellular immune responses in elderly subjects, practitioners or not, of physical exercise training.
METHODS


Eighty-four elderly people (aged 72.6 ± 6.1), non-practitioners (NP,  n  = 31), and practitioners of combined-exercise training (CET,  n  = 53) were submitted to Influenza virus vaccination and supplemented with Gln (0.3 g/kg of weight + 10 g of maltodextrin, groups: NP-Gln ( n  = 14), and CET-Gln ( n  = 26)), or placebo (10 g of maltodextrin, groups: NP-PL ( n  = 17), and CET-PL ( n  = 27)). Blood samples were collected pre (baseline) and 30 days post-vaccination and supplementation.
RESULTS


Comparing with the baseline values, whereas the NP-Gln and CET-PL groups showed higher specific-IgM levels, the CET-Gln group showed higher specific-IgM and IgA levels post-vaccination. The titer rate of hemagglutination inhibition was higher in the CET-Gln, NP-PL, and NP-Gln groups post-vaccination than baseline values. The absolute number of naive and effector CD4+ T cells was higher especially in the NP-Gln and CET-Gln groups, whilst activated CD4+ T cells were higher in CET subgroups post-vaccination.
CONCLUSION


Our results showed that both l-glutamine supplementation and combined-exercise training can improve the immune responses to the Influenza virus vaccine in elderly subjects.",2020,The absolute number of naive and effector CD4+ T cells was higher especially in the NP-Gln and CET-,"['Elderly Subjects', 'elderly subjects', 'elderly subjects, practitioners or not, of physical exercise training', 'Eighty-four elderly people (aged 72.6 ± 6.1), non-practitioners (NP,  n  = 31), and practitioners of combined-exercise training (CET,  n  = 53']","['Combined Exercise Training and l-Glutamine Supplementation Enhances', 'L-glutamine (Gln) supplementation', 'CET-Gln', 'CET-PL', 'l-glutamine supplementation and combined-exercise training', 'Influenza virus vaccination and supplemented with Gln (0.3 g/kg of weight + 10 g of maltodextrin, groups: NP-Gln', 'placebo (10 g of maltodextrin, groups: NP-PL']","['specific-IgM and IgA levels', 'specific-IgM levels', 'activated CD4+ T cells', 'absolute number of naive and effector CD4+ T cells', 'titer rate of hemagglutination inhibition', 'immune responses']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}]",84.0,0.063087,The absolute number of naive and effector CD4+ T cells was higher especially in the NP-Gln and CET-,"[{'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Monteiro', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Tamaris', 'Initials': 'T', 'LastName': 'Roseira', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Jonatas B', 'Initials': 'JB', 'LastName': 'Amaral', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'Paixão', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Ewin B', 'Initials': 'EB', 'LastName': 'Almeida', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Foster', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Sperandio', 'Affiliation': 'Method Faculty of Sao Paulo (FAMESP), Sao Paulo CEP 04046-200, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Gislene R', 'Initials': 'GR', 'LastName': 'Amirato', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Juliana S', 'Initials': 'JS', 'LastName': 'Apostólico', 'Affiliation': 'Department of Microbiology, Immunology and Parasitology, Federal University of Sao Paulo (UNIFESP/EPM), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Carlos A F', 'Initials': 'CAF', 'LastName': 'Santos', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}, {'ForeName': 'Eduardo S', 'Initials': 'ES', 'LastName': 'Felismino', 'Affiliation': 'Post-graduation Program in Health Science, Santo Amaro University (UNISA), Sao Paulo CEP 04829300, Brazil.'}, {'ForeName': 'Fabyano B', 'Initials': 'FB', 'LastName': 'Leal', 'Affiliation': 'Institute of Biomedical Science of University of Sao Paulo (USP), Sao Paulo CEP 05508-900, Brazil.'}, {'ForeName': 'Luciano M', 'Initials': 'LM', 'LastName': 'Thomazelli', 'Affiliation': 'Institute of Biomedical Science of University of Sao Paulo (USP), Sao Paulo CEP 05508-900, Brazil.'}, {'ForeName': 'Edison L', 'Initials': 'EL', 'LastName': 'Durigon', 'Affiliation': 'Institute of Biomedical Science of University of Sao Paulo (USP), Sao Paulo CEP 05508-900, Brazil.'}, {'ForeName': 'Danielle B L', 'Initials': 'DBL', 'LastName': 'Oliveira', 'Affiliation': 'Institute of Biomedical Science of University of Sao Paulo (USP), Sao Paulo CEP 05508-900, Brazil.'}, {'ForeName': 'Rodolfo P', 'Initials': 'RP', 'LastName': 'Vieira', 'Affiliation': 'Brazilian Institute of Teaching and Research in Pulmonary and Exercise Immunology (IBEPIPE), Sao Jose dos Campos CEP 12245-520, Brazil.'}, {'ForeName': 'Juliana M B', 'Initials': 'JMB', 'LastName': 'Santos', 'Affiliation': 'Post-graduation Program in Science of Human and Rehabilitation, Federal University of Sao Paulo (UNIFESP), Santos CEP 11060-001, Brazil.'}, {'ForeName': 'André L L', 'Initials': 'ALL', 'LastName': 'Bachi', 'Affiliation': 'Department of Otorhinolaryngology, ENT Lab, Federal University of Sao Paulo (UNIFESP), Sao Paulo CEP 04025-002, Brazil.'}]",Vaccines,['10.3390/vaccines8040685']
2465,33207606,Effects of Beetroot Powder with or without L-Arginine on Postprandial Vascular Endothelial Function: Results of a Randomized Controlled Trial with Abdominally Obese Men.,"BACKGROUND


Through effects on nitric oxide bioavailability, vascular endothelial function is improved after the intake of a high amount of nitrate or L-arginine, but decreased after the intake of a high-fat meal. Therefore, we compared the effects of beetroot powder with or without L-arginine on postprandial brachial artery flow-mediated vasodilation (FMD) after consumption of a high-fat mixed-meal.
METHODS


Eighteen abdominally obese men completed this randomized, double-blinded, cross-over trial. The study consisted of five test days, each separated by a wash-out period of at least one week. Participants received in random order, a blended meal with a control or nutritional supplement consisting of beetroot powder providing 200 mg nitrate, beetroot with 0.8 g of L-arginine, beetroot with 1.5 g of L-arginine, or 3.0 g of L-arginine. Participants then fasted and 2 h postprandial FMD measurements were performed.
RESULTS


No significant differences between meals were observed for postprandial FMD ( p  = 0.45) levels. However, there was a non-significant trend towards a more beneficial postprandial FMD response with the beetroot-containing meals as compared with meals without beetroot.
CONCLUSION


This trial could not provide evidence for beneficial additive effects of a single dose of beetroot powder combined with L-arginine on postprandial endothelial function in abdominally obese men.",2020,No significant differences between meals were observed for postprandial FMD ( p  = 0.45) levels.,"['Eighteen abdominally obese men', 'abdominally obese men', 'Abdominally Obese Men']","['Beetroot Powder with or without L-Arginine', 'beetroot powder combined with L-arginine', 'blended meal with a control or nutritional supplement consisting of beetroot powder providing 200 mg nitrate, beetroot with 0.8 g of L-arginine, beetroot with 1.5 g of L-arginine, or 3.0 g of L-arginine', 'beetroot powder with or without L-arginine']","['Postprandial Vascular Endothelial Function', 'beneficial postprandial FMD response', 'postprandial endothelial function', 'postprandial FMD', 'postprandial brachial artery flow-mediated vasodilation (FMD', 'nitric oxide bioavailability, vascular endothelial function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.307233,No significant differences between meals were observed for postprandial FMD ( p  = 0.45) levels.,"[{'ForeName': 'Ellen T H C', 'Initials': 'ETHC', 'LastName': 'Smeets', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Vogel-Van den Bosch', 'Affiliation': 'Danone Nutricia Research, 3584 Utrecht, The Netherlands.'}, {'ForeName': 'Robert J J', 'Initials': 'RJJ', 'LastName': 'Hageman', 'Affiliation': 'Danone Nutricia Research, 3584 Utrecht, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}]",Nutrients,['10.3390/nu12113520']
2466,33207811,The Effect of Smartphone-Based Cognitive Training on the Functional/Cognitive Markers of Schizophrenia: A One-Year Randomized Study.,"BACKGROUND


Cognitive impairment is associated with long-term disability that results in the deterioration of both the social and professional status of individuals with schizophrenia. The impact of antipsychotic therapy on cognitive function is insufficient. Cognitive training is therefore proposed as a tool for cognitive rehabilitation in schizophrenia. In this study we investigated the effect of self-administered cognitive training using a smartphone-based application on the cognitive function of paranoid schizophrenia patients focusing on response time, correct answer rate, incorrect answer rate, and fatigability to check, if these functions can be functional markers of successful cognitive-smartphone rehabilitation.
METHODS


1-year multicenter, open-label randomized study was conducted on 290 patients in a state of symptomatic remission. 191 patients were equipped with the full version of the application and conducted cognitive training twice a week. Reference group ( n  = 99) was provided with a version of the application having only limited functionality, testing the cognitive performance of patients every 6 months.
RESULTS


Statistically significant improvement was observed in both the rate of correct answers (by 4.8%,  p  = 0.0001), and cognitive fatigability (by 2.9%,  p  = 0.0001) in the study group, along with a slight improvement in the rate of incorrect answers (by 0.9%,  p  = 0.15). In contrast, the reference group, who performed cognitive training every 6 months, demonstrated no significant changes in any cognitive activities.
CONCLUSIONS


Cognitive trainings facilitated by a smartphone-based application, performed regularly for a longer period of time are feasible and may have the potential to improve the cognitive functioning of individuals with schizophrenia. Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.",2020,Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.,"['paranoid schizophrenia patients', 'schizophrenia patients', 'Schizophrenia', 'individuals with schizophrenia', '290 patients in a state of symptomatic remission', '191 patients']","['self-administered cognitive training', 'smartphone-based application', 'Cognitive training', 'antipsychotic therapy', 'Smartphone-Based Cognitive Training']","['rate of correct answers', 'rate of incorrect answers', 'cognitive activities', 'cognitive fatigability']","[{'cui': 'C0036349', 'cui_str': 'Paranoid schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}]",290.0,0.0268362,Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Krzystanek', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Krysta', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Borkowski', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Skałacka', 'Affiliation': 'Institute of Psychology, University of Opole, Kopernika 11A Street, 45-040 Opole, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Przybyło', 'Affiliation': 'Multispecialistic Voivodship Medical Clinic in Katowice, Lompy 16, 40-038 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Pałasz', 'Affiliation': 'Department of Histology, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Medyków 18, 40-752 Katowice, Poland.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Mucic', 'Affiliation': 'The Little Prince Treatment Centre, Havneholmen 82, 5th, V 1561 Copenhagen, Denmark.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Martyniak', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Napoleon', 'Initials': 'N', 'LastName': 'Waszkiewicz', 'Affiliation': 'Department of Psychiatry, Medical University of Białystok, Plac Brodowicza 1 Str., 16-070 Choroszcz, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9113681']
2467,33207828,"Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington's Disease Patients-A Randomized Phase 2 Clinical Trial.","SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington's disease (HD) patients with irritability. Our goal was to determine whether SRX246 was safe and well tolerated in these HD patients given its potential use for the treatment of problematic neuropsychiatric symptoms. Participants were randomized to receive placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246. Assessments included standard safety tests, the Unified Huntington's Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors. The groups had comparable demographics, features of HD and baseline irritability. Eighty-two out of 106 subjects randomized completed the trial on their assigned dose of drug. One-sided exact-method confidence interval tests were used to reject the null hypothesis of inferior tolerability or safety for each dose group vs. placebo. Apathy and suicidality were not affected by SRX246. Most adverse events in the active arms were considered unlikely to be related to SRX246. The compound was safe and well tolerated in HD patients and can be moved forward as a candidate to treat irritability and aggression.",2020,"It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials.","['Eighty-two out of 106 subjects', ""early symptomatic Huntington's disease (HD) patients with irritability"", ""Irritable Huntington's Disease Patients""]","['placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246', 'placebo', 'SRX246', 'SRX246, a Vasopressin 1a Antagonist']","[""standard safety tests, the Unified Huntington's Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors"", 'Apathy and suicidality', 'Safety and Tolerability', 'safe and well tolerated', 'HD and baseline irritability', 'impulsive aggression, fear, depression and anxiety']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3713502', 'cui_str': 'SRX246'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0858853', 'cui_str': 'Impulsive aggression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",106.0,0.171041,"It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Brownstein', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Neal G', 'Initials': 'NG', 'LastName': 'Simon', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Yankey', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Hilda T', 'Initials': 'HT', 'LastName': 'Maibach', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Coffey', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Conwit', 'Affiliation': 'National Institutes of Health, NINDS, Bethesda, MD 20852, USA.'}, {'ForeName': 'Codrin', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'National Institutes of Health, NINDS, Bethesda, MD 20852, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Medstar Georgetown University Hospital, Washington, DC 20007, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Hersch', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Dixie J', 'Initials': 'DJ', 'LastName': 'Ecklund', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Eve M', 'Initials': 'EM', 'LastName': 'Damiano', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Debra E', 'Initials': 'DE', 'LastName': 'Itzkowitz', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Shifang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Marianne K', 'Initials': 'MK', 'LastName': 'Chase', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ 85013, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Department of Neurology, Cooper University Hospital, Camden, NJ 08103, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Thornell', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gladden', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Costigan', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Suilleabhain"", 'Affiliation': 'Department of Neurology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Marshall', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Chesire', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Deritis', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Adams', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Vanderbilt University, Nashville, TN 37212, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lowen', 'Affiliation': 'Department of Neurology, Vanderbilt University, Nashville, TN 37212, USA.'}, {'ForeName': 'H Diana', 'Initials': 'HD', 'LastName': 'Rosas', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Amie L', 'Initials': 'AL', 'LastName': 'Hiller', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Keith', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gruenwald', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Molloy', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Factor', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Sperin', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Bega', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Zsazsa R', 'Initials': 'ZR', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Seeberger', 'Affiliation': 'Department of Neurology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Benge', 'Affiliation': 'Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Sandra K', 'Initials': 'SK', 'LastName': 'Kostyk', 'Affiliation': 'Department of Neurology, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Daley', 'Affiliation': 'Department of Neurology, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Department of Neurology, University of California Los Angeles, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Suski', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Conlon', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lowenhaupt', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Quigg', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Perlmutter', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, MO 63110, USA.'}, {'ForeName': 'Brenton A', 'Initials': 'BA', 'LastName': 'Wright', 'Affiliation': 'Department of Neurosciences, University of California San Diego, La Jolla, CA 92121, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Most', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, MO 63110, USA.'}, {'ForeName': 'Guy J', 'Initials': 'GJ', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurology, Stony Brook University Hospital, Stony Brook, NY 11794, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lamb', 'Affiliation': 'Department of Neurology, Stony Brook University Hospital, Stony Brook, NY 11794, USA.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Chuang', 'Affiliation': 'Department of Neurology, Swedish Medical Center, Seattle, WA 98122, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Singer', 'Affiliation': 'Department of Neurology, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Marder', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Moran', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Singleton', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Zorn', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Paola V', 'Initials': 'PV', 'LastName': 'Wall', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Dubinsky', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Drazinic', 'Affiliation': 'Department of Clinical Sciences, Florida State University, Tallahassee, FL 32306, USA.'}]",Journal of clinical medicine,['10.3390/jcm9113682']
2468,33207841,Effect of Using an 8-Figure Shoulder Brace on Posture and Muscle Activities during the Performance of Dental Hygiene Procedures.,"The incidence of work-related musculoskeletal disorders (MSDs) among dental workers has been increasing. Many ergonomic devices and accessories have been introduced. The aim of this study was to investigate the effects of an 8-figure shoulder brace on posture-related muscle activities in dental hygiene practitioners during scaling procedures. In this study, 33 participants (age: 21.9 ± 2.1 years, height: 162.0 ± 6.0 cm, weight: 55.8 ± 9.0 kg, body mass index: 21.2 ± 2.4 kg/m 2 ) performed the scaling procedure with and without the 8-figure shoulder brace in a randomized order. The normalized electromyography activity in the amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints) were simultaneously recorded during scaling. A paired  t  test was used to compare the differences in muscle kinematics, with the alpha level set at 0.05. The dental hygienists who wore the 8-figure shoulder brace during scaling showed thoracic and lumbar extension, improved sitting postures, and reduced shoulder joint abduction. However, we also observed an unintended increase in internal rotation. Use of the 8-figure shoulder brace could prevent work-related MSDs in lumbar and thoracic regions by reducing the effort exerted by the upper trapezius and deltoid muscles, despite the increased muscular effort of the cervical erector spinae.",2020,"The normalized electromyography activity in the amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints) were simultaneously recorded during scaling.","['dental hygiene practitioners during scaling procedures', '33 participants (age: 21.9 ± 2.1 years, height: 162.0 ± 6.0 cm, weight: 55.8 ± 9.0 kg, body mass index: 21.2 ± 2.4 kg/m 2 ) performed the']","['8-Figure Shoulder Brace', 'scaling procedure with and without the 8-figure shoulder brace', '8-figure shoulder brace']","['Posture and Muscle Activities', 'thoracic and lumbar extension, improved sitting postures, and reduced shoulder joint abduction', 'internal rotation', 'amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints', 'normalized electromyography activity']","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",33.0,0.0249432,"The normalized electromyography activity in the amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints) were simultaneously recorded during scaling.","[{'ForeName': 'Tae-Lim', 'Initials': 'TL', 'LastName': 'Yoon', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Sciences, Cheongju University, Cheongju 28503, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Dental Hygiene, College of Health and Medical Sciences, Cheongju University, Cheongju 28503, Korea.'}, {'ForeName': 'Han-Na', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, College of Health and Medical Sciences, Cheongju University, Cheongju 28503, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17228494']
2469,33207935,Moderation of Prazosin's Efficacy by Alcohol Withdrawal Symptoms.,"OBJECTIVE


Alcohol use disorder (AUD) is a leading cause of global disease burden. Chronic, heavy use increases the likelihood of alcohol withdrawal symptoms and associated secondary outcomes of alcohol craving and mood, anxiety, and sleep disturbances, which are predictive of poor treatment outcomes. The authors examined whether alcohol withdrawal symptoms moderate the efficacy of prazosin in reducing alcohol intake and associated secondary outcomes.
METHODS


A 12-week, double-blind, randomized, controlled proof-of-concept trial of prazosin (16 mg/day, with a 2-week titration) was conducted in community-recruited adults with current alcohol dependence (N=100) with varying levels of alcohol withdrawal symptoms assessed at treatment entry. Primary outcomes were daily self-reported drinking days and heavy drinking days, and secondary outcomes were average drinks/day and mood, anxiety, craving, and sleep quality ratings.
RESULTS


Modified intent-to-treat analyses indicated a significant interaction of alcohol withdrawal symptom score by treatment by full-dose treatment period (weeks 3-12) for drinking days, heavy drinking days, and average drinks/day. By week 12, participants with high alcohol withdrawal symptoms on prazosin reported 7.07% heavy drinking days and 27.46% drinking days, while those on placebo had 35.58% heavy drinking days and 58.47% drinking days (heavy drinking days: odds ratio=0.14, 95% CI=0.058, 0.333; drinking days: odds ratio=0.265, 95% CI=0.146, 0.481). No such benefit of prazosin was observed in those reporting low or no alcohol withdrawal symptoms. Individuals with high alcohol withdrawal symptoms on prazosin compared with placebo also showed significantly improved anxiety, depression, and alcohol craving over the course of the trial.
CONCLUSIONS


The findings indicate that alcohol withdrawal symptoms are a significant moderator of prazosin treatment response for alcohol use outcomes and for associated symptoms of alcohol craving, anxiety, and mood symptoms. These data support further evaluation of alcohol withdrawal symptoms as a prognostic indicator of prazosin's efficacy in the treatment of AUD.",2020,"RESULTS


Modified intent-to-treat analyses indicated a significant interaction of alcohol withdrawal symptom score by treatment by full-dose treatment period (weeks 3-12) for drinking days, heavy drinking days, and average drinks/day.","['Individuals with high alcohol withdrawal symptoms on', 'community-recruited adults with current alcohol dependence (N=100) with varying levels of alcohol withdrawal symptoms assessed at treatment entry']","['prazosin', 'placebo', 'Prazosin']","['likelihood of alcohol withdrawal symptoms', 'anxiety, depression, and alcohol craving', 'alcohol craving, anxiety, and mood symptoms', 'alcohol craving and mood, anxiety, and sleep disturbances', 'alcohol intake', 'alcohol withdrawal symptom score', 'daily self-reported drinking days and heavy drinking days, and secondary outcomes were average drinks/day and mood, anxiety, craving, and sleep quality ratings']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032912', 'cui_str': 'Prazosin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0236663', 'cui_str': 'Alcohol withdrawal syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",100.0,0.0388213,"RESULTS


Modified intent-to-treat analyses indicated a significant interaction of alcohol withdrawal symptom score by treatment by full-dose treatment period (weeks 3-12) for drinking days, heavy drinking days, and average drinks/day.","[{'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wemm', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Fogelman', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Verica', 'Initials': 'V', 'LastName': 'Milivojevic', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Morgan', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Angarita', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Fox', 'Affiliation': 'Yale Stress Center (Sinha, Wemm, Fogelman, Milivojevic, Hermes), Department of Psychiatry (Sinha, Wemm, Fogelman, Milivojevic, Morgan, Angarita, Hermes), and Department of Neuroscience (Sinha), Yale University School of Medicine, New Haven, Conn.; Department of Psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y. (Fox).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.20050609']
2470,33212557,[Effect of open-lung ventilation strategy on oxygenation-impairment during laparoscopic colorectal cancer resection].,"Objective:  After general anesthesia and mechanical ventilation for laparoscopic colorectal cancer resection, about 90% of patients would have different degrees of atelectasis. Authors speculated that an open-lung strategy (OLS) comprising moderate positive end-expiratory pressure (PEEP) and intermittent recruitment maneuvers (RM) can reduce atelectrauma and thus reduce the incidence of oxygenation-impairment during low-tidal-volume ventilation for laparoscopic colorectal cancer resection. The purpose of this study was to verify this hypothesis and provide a better intraoperative ventilation scheme for laparoscopic colorectal cancer resection.  Methods:  This was a prospectively randomized controlled clinical trial which was approved by the Ethics Committee of the Sixth Affiliated Hospital, Sun Yat-sen University (2017ZSLYEC-002), and registered at the ClinicalTrials.gov (NCT03160144). From January to July 2017, patients who underwent laparoscopic colorectal cancer resection, with age > 40 years, estimated pneumoperitoneum time ≥ 1.5 h, pulse oxygen saturation ≥ 92%, and risk grade for postoperative pulmonary complications ≥ 2 were prospectively enrolled. The patients with American Society of Anesthesiologists physical status ≥ IV, body mass index ≥ 30 kg/m(2), pneumonia, acute respiratory failure or sepsis within 1 month, severe chronic obstructive pulmonary disease, pulmonary bullae and progressive neuromuscular diseases, and those participating in other interventional clinical trials were excluded. The enrolled patients were randomly assigned (1:1) to the OLS group (with a PEEP of 6-8 cm H(2)O and intermittent RM), and the NOLS group (without using PEEP and RM). Partial pressure of arterial oxygen (PaO(2)) /fraction of inspired oxygen (FiO(2)) and shunt fraction (Q(S)/Q(T)) were calculated via arterial and central venous blood gas analysis performed at 0.5 h (T(1)), 1.5 h (T(2)) after pneumoperitoneum induction and at 20 min after admission to the recovery room. Driving pressure immediately before pneumoperitoneum induction (T(0)) and at T(2) were calculated via monitoring data. The primary outcome was oxygenation-impairment (PaO(2)/FiO(2) ≤ 300 mmHg) during mechanical ventilation.  Results:  In each group, 48 patients under general anesthesia and low-tidal-volume ventilation were included in the final analysis. During ventilation, the oxygenation-impairment occurred in 7 patients (14.6%) of OLS group and in 17 patients (35.4%) of NOLS group, whose difference was statistically significant between two groups (χ(2)=5.556, RR=0.31, 95%CI: 0.12 to 0.84,  P =0.033). During ventilation, the patients in the OLS group had higher PaO(2)/FiO(2) [T(1): (427±103) mmHg vs. (366±109) mmHg,  t =-2.826,  P =0.006; T(2): (453±103) mmHg vs. (388±122) mmHg,  t =-2.739,  P =0.007], lower Q(S)/Q(T) [ T(1): (9.2±6.5) % vs. (12.6±7.7) %,  t =2.322,  P =0.022; T(2): (7.0±5.8)% vs.(10.9±9.2)%,  t =2.408,  P =0.019], and lower driving pressure [T(0): (6±3) cm H(2)O vs. (10±2) cm H(2)O,  t =7.421,  P <0.001; T(2): (13±3) cm H(2)O vs. (17±4) cm H(2)O,  t =5.417,  P <0.001] than those in the NOLS group, with stratistical differences in all comparisons. In recovery room, though PaO(2)/FiO(2) [(70.3±9.4) mmHg vs. (66.8±9.4) mmHg,  P =0.082] was still higher and Q(S)/Q(T) [(18.6±8.3)% vs. (21.8±8.4)%,  P =0.070] was still lower in the OLS group as compared to the NOLS group, the differences were not statistically significant (both  P >0.05).  Conclusion:  The application of such an OLS during low-tidal-volume ventilation can greatly reduce the incidence of oxygenation-impairment in laparoscopic colorectal cancer resection, and such effect may last to the period of emergence from anesthesia.",2020,"During ventilation, the patients in the OLS group had higher PaO(2)/FiO(2)","['patients with American Society of Anesthesiologists physical status ≥ IV, body mass index ≥ 30 kg/m(2), pneumonia, acute respiratory failure or sepsis within 1 month, severe chronic obstructive pulmonary disease, pulmonary bullae and progressive neuromuscular diseases, and those participating in other interventional clinical trials were excluded', 'T(1', '48 patients under general anesthesia and low-tidal-volume ventilation', 'laparoscopic colorectal cancer resection', 'From January to July 2017, patients who underwent laparoscopic colorectal cancer resection, with age > 40 years, estimated pneumoperitoneum time ≥ 1.5 h, pulse oxygen saturation ≥ 92%, and risk grade for postoperative pulmonary complications ≥ 2 were prospectively enrolled']","['open-lung strategy (OLS) comprising moderate positive end-expiratory pressure (PEEP) and intermittent recruitment maneuvers (RM', 'Driving pressure immediately before pneumoperitoneum induction (T(0)) and at T(2', 'OLS', 'PaO(2)/FiO(2', 'general anesthesia and mechanical ventilation', 'NOLS group (without using PEEP and RM', 'OLS group (with a PEEP of 6-8 cm H(2)O and intermittent RM', 'open-lung ventilation strategy', 'intraoperative ventilation scheme', 'NOLS']","['higher PaO(2)/FiO(2', 'oxygenation-impairment (PaO(2)/FiO(2) ≤ 300 mmHg) during mechanical ventilation', 'oxygenation-impairment', 'lower Q(S)/Q(T', 'lower driving pressure [T(0', 'Partial pressure of arterial oxygen (PaO(2', 'fraction of inspired oxygen (FiO(2)) and shunt fraction (Q(S)/Q(T', 'still higher and Q(S)/Q(T']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.180453,"During ventilation, the patients in the OLS group had higher PaO(2)/FiO(2)","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.'}, {'ForeName': 'Z N', 'Initials': 'ZN', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.'}, {'ForeName': 'S Q', 'Initials': 'SQ', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510655, China.'}]",Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery,['10.3760/cma.j.issn.441530-20191209-00507']
2471,33212796,Linkage of Maternal Caregiver Smoking Behaviors on Environmental and Clinical Outcomes of Children with Asthma: A Post-Hoc Analysis of a Financial Incentive Trial Targeting Reduction in Pediatric Tobacco Smoke Exposures.,"(1)  Background : Monthly variability in smoking behaviors in caregivers of pediatric asthmatics yields questions of how much and when does smoking reduction result in improved environmental and clinical outcomes. (2)  Methods : Post hoc analysis of data from a 6 month pilot randomized-control trial occurring from May 2017 to May 2018 in Baltimore City (MD, USA). The initial trial's primary intervention explored the utility of financial incentives in modifying caregiver smoking behaviors. Post hoc analyses examined all dyads independent of the initial trial's randomization status. All caregivers received pediatric tobacco smoke harm reduction education, in addition to monthly encouragement to access the state tobacco quitline for individual phone-based counseling and nicotine replacement therapy. Maternal caregivers who were active cigarette smokers and their linked asthmatic child (aged 2-12 years) were grouped into two classifications (""high"" versus ""low"") based on the child and caregiver's cotinine levels. A ""low"" cotinine level was designated by at least a 25% reduction in cotinine levels during 3 months of the trial period; achieving ≤2 months of low cotinine levels defaulted to the ""high"" category. Twenty-seven dyads (caregivers and children) (total  n  = 54) were assigned to the ""high"" category, and eighteen dyads (caregivers and children) (total  n  = 36) were allocated to the ""low"" category. The primary outcome measure was the correlation of caregiver cotinine levels with pediatric cotinine values. Secondary outcomes included asthma control, in addition to caregiver anxiety and depression. (3)  Results : Caregivers with 3 months of ≥25% decrease in cotinine levels had a significantly greater mean change in child cotinine levels ( p  = 0.018). ""Low"" caregiver cotinine levels did not significantly improve pediatric asthma control (OR 2.12 (95% CI: 0.62-7.25)). Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization ( p  = 0.079); (4)  Conclusion : Reduced pediatric cotinine levels were seen in caregivers who reduced their smoking for at least 3 months, but clinical outcome measures remained unchanged.",2020,"Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization ( p  = 0.079);","['Maternal caregivers who were active cigarette smokers and their linked asthmatic child (aged 2-12 years', 'Twenty-seven dyads (caregivers and children) ', 'Pediatric Tobacco Smoke Exposures', 'from May 2017 to May 2018 in Baltimore City (MD, USA', 'Children with Asthma', 'total  n  = 54) were assigned to the ""high"" category, and eighteen dyads (caregivers and children) (total  n  = 36']","['pediatric tobacco smoke harm reduction education, in addition to monthly encouragement to access the state tobacco quitline for individual phone-based counseling and nicotine replacement therapy']","['child cotinine levels', 'Caregiver anxiety and depression outcomes', 'cotinine levels', 'correlation of caregiver cotinine levels with pediatric cotinine values', 'pediatric cotinine levels', 'pediatric asthma control', 'asthma control, in addition to caregiver anxiety and depression', 'Low"" caregiver cotinine levels', 'Patient Health Questionnaire (PHQ)-4 scores']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",54.0,0.0563195,"Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization ( p  = 0.079);","[{'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Jassal', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Cassia', 'Initials': 'C', 'LastName': 'Lewis-Land', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17228502']
2472,33212849,Nutritional Bar with Potato-Based Resistant Starch Attenuated Post-Prandial Glucose and Insulin Response in Healthy Adults.,"Resistant starch is a non-digestible starch fraction and is classified as fiber. Beyond naturally occurring fiber sources, starches can be modified to resist digestion, increase their fiber content and provide physiological benefits. The current study examined acute postprandial glycemic responses of VERSAFIBE™ 1490 resistant starch type-4, containing 90% total dietary fiber (TDF, AOAC (Association of Official Analytical Collaboration International) 991.43 method). In a double-blind, randomized, placebo-controlled, cross-over study, healthy adults ( n  = 38) consumed a nutritional bar containing either control (2 g), medium (21 g) or high (30 g) fiber. The test bars were matched with control for available carbohydrates, fat and protein. Venous glucose, insulin, and capillary glucose were measured. Mean ± SEM capillary glucose incremental area-under-curve (iAUC0)-120 min in min*mmol/L was lower ( p  < 0.005) for both fiber bars (136.2 ± 9.2 and 137.0 ± 10.4 for the medium and high fiber bars, respectively) compared to the control bar (174.9 ± 13.5). Mean venous insulin iAUC0-120 min in min*pmol/L was also lower for medium (8096.3 ± 894.5) and high fiber (7533.8 ± 932.9) bars, respectively, compared to the control bar (11871.6 ± 1123.9,  p  < 0.001). Peak capillary glucose and venous insulin concentrations were also significantly reduced ( p  < 0.001) after consumption of both fiber bars compared to the control bar. The results of this study suggest that nutritional bars containing potato based RS4 fiber reduced post-consumption glycemic and insulinemic responses when consumed by generally healthy adults.",2020,Peak capillary glucose and venous insulin concentrations were also significantly reduced ( p  < 0.001) after consumption of both fiber bars compared to the control bar.,"['healthy adults ( n  = 38', 'generally healthy adults', 'Healthy Adults']","['consumed a nutritional bar containing either control (2 g), medium (21 g) or high (30 g) fiber', 'placebo', 'Resistant starch', 'nutritional bars containing potato based RS4 fiber', 'Nutritional Bar with Potato-Based Resistant Starch Attenuated Post-Prandial Glucose']","['Mean venous insulin iAUC0', 'Peak capillary glucose and venous insulin concentrations', 'Venous glucose, insulin, and capillary glucose', 'Mean ± SEM capillary glucose incremental area-under-curve (iAUC0)-120 min in min*mmol']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1959943', 'cui_str': '21G'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0201879,Peak capillary glucose and venous insulin concentrations were also significantly reduced ( p  < 0.001) after consumption of both fiber bars compared to the control bar.,"[{'ForeName': 'Vishnupriya', 'Initials': 'V', 'LastName': 'Gourineni', 'Affiliation': 'Global R&D, Ingredion Incorporated, 10 Finderne Ave, Bridgewater, NJ 08807, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Stewart', 'Affiliation': 'Global R&D, Ingredion Incorporated, 10 Finderne Ave, Bridgewater, NJ 08807, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'Midwest Biomedical Research, Addison, IL 60101, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL 60101, USA.'}]","Foods (Basel, Switzerland)",['10.3390/foods9111679']
2473,33213125,"Effect of an oral preparation containing hyaluronic acid, chondroitin sulfate, hydrolyzed collagen type II and hydrolyzed keratin on synovial fluid features and clinical indices in knee osteoarthritis. A pilot study.","The aim of this study was to evaluate the effect of an oral preparation containing a naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate (CS), and hyaluronic acid (HA), and bioactive oligopeptides of natural hydrolyzed keratin (K) in patients affected by knee OA through the evaluation of synovial fluid (SF) and clinical changes before and after treatment. Thirty patients with knee OA and swollen joint were included in the study and submitted to arthrocentesis. Patients were randomized in two groups: 1) the treatment group (N.15) took a dietary supplement containing 120 mg HA, 240 mg CS and 300 mg K once a day for 4 weeks; 2) the control group (N.15) was only submitted to arthrocentesis. Patient symptoms were evaluated at the beginning and at the end of the study by the WOMAC self-assessment questionnaire, the Lequesne algofunctional index, and the VAS forms. SF changes were evaluated by measuring local inflammatory indices, cytokines IL-1β, IL-8, IL-6, IL-10 and GM-CSF. The group of patients treated with the oral supplement showed an improvement in the clinical indices WOMAC (p<0.01), Lequesne (p=0.014) and VAS pain (p<0.01). On the contrary, no significant changes were found in the control group. The SF collected from the treated group showed a reduction of IL-8 (p=0.015), IL-6 and IL-10 levels, while no changes in cytokines were observed in the control group. This pilot study suggests that an oral administration of a preparation containing a combination of HA, CS and K can improve some clinical parameters and affect cytokine concentrations in SF in patients with knee OA.",2020,"SF changes were evaluated by measuring local inflammatory indices, cytokines IL-1β, IL-8, IL-6, IL-10 and GM-CSF.","['patients with knee OA', 'knee osteoarthritis', 'Thirty patients with knee OA and swollen joint were included in the study and submitted to arthrocentesis', 'patients affected by knee OA']","['dietary supplement containing 120 mg HA, 240 mg CS', 'oral preparation containing hyaluronic acid, chondroitin sulfate, hydrolyzed collagen type II and hydrolyzed keratin', 'oral preparation containing a naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate (CS), and hyaluronic acid (HA), and bioactive oligopeptides of natural hydrolyzed keratin (K']","['reduction of IL-8', 'cytokine concentrations', 'IL-6 and IL-10 levels', 'VAS pain', 'clinical indices WOMAC', 'cytokines', 'local inflammatory indices, cytokines IL-1β, IL-8, IL-6, IL-10 and GM-CSF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0009331', 'cui_str': 'Collagen type II'}, {'cui': 'C0010803', 'cui_str': 'Cytokeratin'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0028954', 'cui_str': 'Oligopeptides'}, {'cui': 'C0205296', 'cui_str': 'Natural'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}]",30.0,0.0337805,"SF changes were evaluated by measuring local inflammatory indices, cytokines IL-1β, IL-8, IL-6, IL-10 and GM-CSF.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Oliviero', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. francesca.oliviero@unipd.it.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ramonda', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. roberta.ramonda@unipd.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hoxha', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. arielahoxha@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Scanu', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. anna.scanu@unipd.it.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Galozzi', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. paola.galozzi@unipd.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Favero', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. faveromarta@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Frallonardo', 'Affiliation': 'Rheumatology Unit, Department of Medicine - DIMED, University of Padova. paola.frallonardo65@gmail.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Punzi', 'Affiliation': 'High Specialty Rehabilitation Hospital, Motta di Livenza (TV), Italy; Centre for Gout and Metabolic Bone and Joint Diseases, Rheumatology, SS Giovanni and Paolo Hospital, Venice. punzileonardo@gmail.com.'}]",Reumatismo,['10.4081/reumatismo.2020.1272']
2474,33213185,Analgesic and opioid use for patients discharged from the Emergency Department with ureteral stones.,"OBJECTIVE


To describe and characterize the analgesic and opioid use for patients discharged from the emergency department with renal colic due to ureteral stone.
METHODS


This is a secondary analysis of a multi-center prospective trial of emergency department patients diagnosed by computed tomography (CT) scan with a symptomatic ureteral stone < 9 mm in diameter. Participants were contacted after randomization on days 2, 7, 15, 20 and 29 and reported opioid and non-opioid analgesic use and stone passage. CT scan was repeated on day 29-36 to confirm passage.
RESULTS


Out of 403 participants, 314 (77.9%) took any analgesic after discharge and 199 (49.4%) took opioids. Opioids were more commonly used in younger patients (p=0.04) and in those with a family history of stones (p=0.003). Stone size and tamsulosin use were not associated with analgesic utilization. Shorter time to passage and more distal stone location was associated with less analgesic and opioid use. For those that did not expel a stone, 55.0% took opioids at any time; and, for those that did expel a stone, 31.9% took opioids before the stone was expelled and 15.7% took opioids at any time after stone was expelled.
CONCLUSIONS


Factors associated with increased use of analgesics in patients discharged from the emergency department include a longer time to stone passage, no spontaneous passage and proximal position of the stone in the ureter. Some patients continue to use analgesics after stone has passed but most have stopped using by day 29. Study registered at https://clinicaltrials.gov (NCT00382265).",2020,Opioids were more commonly used in younger patients (p=0.04) and in those with a family history of stones (p=0.003).,"['Out of 403 participants, 314 (77.9%) took any analgesic after discharge and 199 (49.4%) took opioids', 'patients discharged from the Emergency Department with ureteral stones', 'patients discharged from the emergency department with renal colic due to ureteral stone', 'emergency department patients diagnosed by computed tomography (CT) scan with a symptomatic ureteral stone < 9 mm in diameter']",['opioid and non-opioid analgesic use and stone passage'],"['Shorter time to passage and more distal stone location', 'CT scan']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",403.0,0.0532764,Opioids were more commonly used in younger patients (p=0.04) and in those with a family history of stones (p=0.003).,"[{'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Meltzer', 'Affiliation': 'The George Washington University School of Medicine and Health Sciences, 43989, Emergency Medicine, Washington, District of Columbia, United States; ameltzer@mfa.gwu.edu.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Wolfson', 'Affiliation': 'University of Pittsburgh School of Medicine, 12317, Emergency Medicine, Pittsburgh, Pennsylvania, United States; wolfsonab@upmc.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mufarrij', 'Affiliation': 'The George Washington University School of Medicine and Health Sciences, 43989, Urology, Washington, District of Columbia, United States; pmufarrij@mfa.gwu.edu.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'MacPherson', 'Affiliation': 'The George Washington University Biostatistics Center, 98175, Rockville, Maryland, United States; coram@bsc.gwu.edu.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Montano', 'Affiliation': 'The George Washington University School of Medicine and Health Sciences, 43989, Emergency Medicine, Washington, District of Columbia, United States; nmontano@mfa.gwu.edu.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kirkali', 'Affiliation': 'NIDDK, 35043, 6707 Democracy Blvd., Bethesda, Maryland, United States, 20892-0001; ziya.kirkali@nih.gov.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Katzen Burrows', 'Affiliation': 'The George Washington University Biostatistics Center, 98175, Rockville, Maryland, United States; pam_b@bsc.gwu.edu.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Jackman', 'Affiliation': 'University of Pittsburgh Medical Center, Urology, 3471 Fifth Ave., Suite 700, Pittsburgh, Pennsylvania, United States, 15213; jackmansv@upmc.edu.'}]",Journal of endourology,['10.1089/end.2020.0835']
2475,33213194,"Individualized, Intraoperative Dosing of Fibrinogen Concentrate for the Prevention of Bleeding in Neonatal and Infant Cardiac Surgery Using Cardiopulmonary Bypass (FIBCON): A Phase 1b/2a Randomized Controlled Trial.","BACKGROUND


Mediastinal bleeding is common following pediatric cardiopulmonary bypass surgery for congenital heart disease. Fibrinogen concentrate (FC) represents a potential therapy for preventing bleeding.
METHODS


We performed a single-center, phase 1b/2a, randomized controlled trial on infants 2.5 to 12 kg undergoing cardiopulmonary bypass surgery, aimed at (1) demonstrating the feasibility of an intraoperative point-of-care test, rotational thromboelastometry, to screen out patients at low risk of postoperative bleeding and then guide individualized FC dosing in high-risk patients and (2) determining the dose, safety, and efficacy of intraoperative FC supplementation. Screening occurred intraoperatively 1-hour before bypass separation using the rotational thromboelastometry variable fibrinogen thromboelastometry maximum clot firmness (FibTEM-MCF; fibrinogen contribution to clot firmness). If FibTEM-MCF ≥7 mm, patients entered the monitoring cohort. If FibTEM-MCF ≤6 mm, patients were randomized to receive FC/placebo (2:1 ratio). Individualized FC dose calculation included weight, bypass circuit volume, hematocrit, and intraoperative measured and desired FibTEM-MCF. The coprimary outcomes, measured 5 minutes post-FC administration were FibTEM-MCF (desired range, 8-13 mm) and fibrinogen levels (desired range, 1.5-2.5 g/L). Secondary outcomes were thrombosis and thrombosis-related major complications and postoperative 24-hour mediastinal blood loss.
RESULTS


We enrolled 111 patients (cohort, n=21; FC, n=60; placebo, n=30); mean (SD) age, 6.4 months (5.8); weight, 5.9 kg (2.0). Intraoperative rotational thromboelastometry screening effectively excluded low-risk patients, in that none in the cohort arm (FibTEM-MCF, ≥7 mm) demonstrated clinically significant early postoperative bleeding (>10 mL/kg per 4 hours). Among randomized patients, the median (range) FC administered dose was 114 mg/kg (51-218). Fibrinogen levels increased from a mean (SD) of 0.91 (0.22) to 1.7 g/L (0.41). The postdose fibrinogen range was 1.2 to 3.3 g/L (72% within the desired range). The corresponding FibTEM-MCF values were as follows: pre-dose, 5.3 mm (1.9); post-dose, 13 mm (3.2). Ten patients (8 FC and 2 placebo) exhibited 12 possible thromboses; none were clearly related to FC. There was an overall difference in mean (SD) 24-hour mediastinal drain loss: cohort, 12.6 mL/kg (6.4); FC, 11.6 mL/kg (5.2); placebo, 17.1 mL/kg (14.3; ANOVA  P =0.02).
CONCLUSIONS


Intraoperative, individualized dosing of FC appears feasible. The need for individualized dosing is supported by the finding that a 4-fold variation in FC dose is required to achieve therapeutic fibrinogen levels. Registration: URL: https://eudract.ema.europa.eu/; Unique identifier: 2013-003532-68. URL: https://www.isrctn.com/; Unique identifier: 50553029.",2020,Fibrinogen levels increased from a mean (SD) of 0.91 (0.22) to 1.7 g/L (0.41).,"['pediatric cardiopulmonary bypass surgery for congenital heart disease', 'infants 2.5 to 12 kg undergoing', 'Bleeding in Neonatal and Infant Cardiac Surgery Using Cardiopulmonary Bypass (FIBCON', '111 patients (cohort, n=21; FC, n=60; placebo, n=30']","['FC', 'placebo', 'intraoperative FC supplementation', 'FC/placebo', 'Fibrinogen concentrate (FC', 'cardiopulmonary bypass surgery', 'Fibrinogen Concentrate']","['mean (SD) 24-hour mediastinal drain loss', '5 minutes post-FC administration were FibTEM-MCF (desired range, 8-13 mm) and fibrinogen levels', 'weight, bypass circuit volume, hematocrit, and intraoperative measured and desired FibTEM-MCF', 'postoperative bleeding', 'thrombosis and thrombosis-related major complications and postoperative 24-hour mediastinal blood loss', 'postdose fibrinogen range', 'corresponding FibTEM-MCF values', 'Fibrinogen levels']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C3879649', 'cui_str': 'Mediastinal drain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2587184', 'cui_str': 'fibrinogen concentrate (human)'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C3661505', 'cui_str': 'Thromboelastometry'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",111.0,0.450196,Fibrinogen levels increased from a mean (SD) of 0.91 (0.22) to 1.7 g/L (0.41).,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Siemens', 'Affiliation': ""Department of Paediatric Intensive Care, Evelina London Children's Hospital, United Kingdom (K.S., J.H., A.G.N., S.M.T.).""}, {'ForeName': 'Beverley J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Department of Haematology, St Thomas' Hospital, London, United Kingdom (B.J.H., K.P.).""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': ""Department of Paediatric Intensive Care, Evelina London Children's Hospital, United Kingdom (K.S., J.H., A.G.N., S.M.T.).""}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Nyman', 'Affiliation': ""Department of Paediatric Intensive Care, Evelina London Children's Hospital, United Kingdom (K.S., J.H., A.G.N., S.M.T.).""}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Parmar', 'Affiliation': ""Department of Haematology, St Thomas' Hospital, London, United Kingdom (B.J.H., K.P.).""}, {'ForeName': 'Shane M', 'Initials': 'SM', 'LastName': 'Tibby', 'Affiliation': ""Department of Paediatric Intensive Care, Evelina London Children's Hospital, United Kingdom (K.S., J.H., A.G.N., S.M.T.).""}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009465']
2476,33213193,Cardiovascular safety of Glimepiride: An indirect comparison from CAROLINA and CARMELINA.,"BACKGROUND


Despite having unquestionable glucose lowering efficacy, current guidelines no more favour the uses of sulphonylureas for CV safety concern, except when cost is an issue. However, formal cardiovascular outcome trial (CVOT) is not available.
MATERIALS AND METHODS


We performed an indirect treatment comparison to find the hazard ratio for 3-point MACE, all-cause death, CV death and non-CV death between glimepiride and placebo based on two large CVOTs which established the CV safety of linagliptin (CARMELINA and CAROLINA).
RESULTS


Glimepiride was shown to have a non-inferior risk compared to placebo for 3-point MACE (HR 1.04, 95% CI 0.850, 1.274), all-cause mortality (HR 1.08, 95% CI 0.880, 1.317), CV death (HR 0.96, 95% CI 0.732, 1.259), and non-CV death (HR 1.24, 95% CI 0.893, 1.733).
CONCLUSION


Cardiovascular safety of glimepiride is re-assuring and may help patients with type 2 diabetes world-over to avail the benefit of this affordable efficacious medication.",2020,"RESULTS


Glimepiride was shown to have a non-inferior risk compared to placebo for 3-point MACE (HR 1.04, 95% CI 0.850, 1.274), all-cause mortality (HR 1.08, 95% CI 0.880, 1.317), CV death (HR 0.96, 95% CI 0.732, 1.259), and non-CV death (HR 1.24, 95% CI 0.893, 1.733).
",[],"['linagliptin', 'placebo', 'glimepiride and placebo', 'glimepiride', 'Glimepiride']","['CV death', 'Cardiovascular safety', 'hazard ratio for 3-point MACE, all-cause death, CV death and non-CV death', 'non-CV death', 'cause mortality']",[],"[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.23718,"RESULTS


Glimepiride was shown to have a non-inferior risk compared to placebo for 3-point MACE (HR 1.04, 95% CI 0.850, 1.274), all-cause mortality (HR 1.08, 95% CI 0.880, 1.317), CV death (HR 0.96, 95% CI 0.732, 1.259), and non-CV death (HR 1.24, 95% CI 0.893, 1.733).
","[{'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Endocrinology, Institute of Post Graduate Medical Education & Research, Kolkata, India.'}, {'ForeName': 'Pradip', 'Initials': 'P', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Endocrinology, Institute of Post Graduate Medical Education & Research, Kolkata, India.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Pandey', 'Affiliation': 'Department of Pharmacy, RV Northland Institute, Greater Noida, UP, India.'}, {'ForeName': 'Purushottam', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Endocrinology, Apollo Gleaneagles Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Pandit', 'Affiliation': 'Department of Endocrinology, Institute of Post Graduate Medical Education & Research, Kolkata, India.'}]",Diabetes & vascular disease research,['10.1177/1479164120973653']
2477,33213207,Spine Treatment Appraisal Report (STAR): Bone Marrow-Derived Stem Cells Improve Neurological Recovery in Participants With Spinal Cord Injury.,"Srivastava RN, Agrahari AK, Singh A, Chandra T, Raj S. Effectiveness of bone marrow-derived mononuclear stem cells for neurological recovery in participants with spinal cord injury: a randomized controlled trial.  Asian J Transfus Sci . 2019;13(2):120-128.",2020,Asian J Transfus Sci .,"['participants with spinal cord injury', 'Participants With Spinal Cord Injury']","['bone marrow-derived mononuclear stem cells', 'Spine Treatment Appraisal Report (STAR): Bone Marrow-Derived Stem Cells']",[],"[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",[],,0.492325,Asian J Transfus Sci .,"[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Dettori', 'Affiliation': 'Spectrum Research, Inc, Steilacoom, WA, USA.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Skelly', 'Affiliation': 'Aggregate Analytics, Inc, Fircrest, WA, USA.'}, {'ForeName': 'Erika D', 'Initials': 'ED', 'LastName': 'Brodt', 'Affiliation': 'Aggregate Analytics, Inc, Fircrest, WA, USA.'}]",Global spine journal,['10.1177/2192568220972706']
2478,33208091,Is preoperative anxiety associated with postoperative delirium in older persons undergoing cardiac surgery? Secondary data analysis of a randomized controlled trial.,"BACKGROUND


Although many studies have reported numerous risk factors for postoperative delirium, data are scarce about preoperative anxiety as a risk factor. The study aimed to investigate the association between preoperative anxiety and postoperative delirium in older patients undergoing cardiac surgery.
METHODS


Secondary data analysis of a randomized, observer-blind, controlled trial. A total of 190 patients 65 years or older and admitted to the intensive care unit and cardiac surgery unit of a university hospital scheduled for elective on-pump cardiac surgery were included. State anxiety was measured preoperatively using the Amsterdam Preoperative Anxiety and Information Scale and the Visual Analogue Scale for anxiety. Incidence of delirium was measured during the first 5 postoperative days using the Confusion Assessment Method for Intensive Care Unit (when ventilated), or the 3 Minute Diagnostic Interview for Confusion Assessment Method (when extubated) and by daily chart review.
RESULTS


Preoperative state anxiety was reported by 31% of the patients and 41% had postoperative delirium. A multiple step logistic regression analyses revealed no association between preoperative anxiety and postoperative delirium. Significant risk factors for postoperative delirium were age (OR = 1.10, 95% CI (1.03-1.18)), activities of daily living (0.69, 95% CI (0.50-0.96)), diabetes mellitus (OR = 3.15, 95% CI (1.42-7.00)) and time on cardiopulmonary bypass (OR = 1.01, 95% CI (1.00 to 1.02)).
CONCLUSIONS


No relationship could be found between preoperative anxiety and postoperative delirium.",2020,"Significant risk factors for postoperative delirium were age (OR = 1.10, 95% CI (1.03-1.18)), activities of daily living (0.69, 95% CI (0.50-0.96)), diabetes mellitus (OR = 3.15, 95% CI (1.42-7.00)) and time on cardiopulmonary bypass (OR = 1.01, 95% CI (1.00 to 1.02)).
","['190 patients 65\u2009years or older and admitted to the intensive care unit and cardiac surgery unit of a university hospital scheduled for elective on-pump cardiac surgery were included', 'older patients undergoing cardiac surgery', 'older persons undergoing cardiac surgery']",[],"['State anxiety', 'Preoperative state anxiety', 'diabetes mellitus', 'postoperative delirium', 'preoperative anxiety and postoperative delirium', 'activities of daily living', 'time on cardiopulmonary bypass', 'Incidence of delirium', 'Amsterdam Preoperative Anxiety and Information Scale and the Visual Analogue Scale for anxiety']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0178808', 'cui_str': 'Preoperative state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",190.0,0.146745,"Significant risk factors for postoperative delirium were age (OR = 1.10, 95% CI (1.03-1.18)), activities of daily living (0.69, 95% CI (0.50-0.96)), diabetes mellitus (OR = 3.15, 95% CI (1.42-7.00)) and time on cardiopulmonary bypass (OR = 1.01, 95% CI (1.00 to 1.02)).
","[{'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Milisen', 'Affiliation': 'Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven - University of Leuven, Kapucijnenvoer 35/4, B-3000, Leuven, Belgium. koen.milisen@kuleuven.be.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Van Grootven', 'Affiliation': 'Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven - University of Leuven, Kapucijnenvoer 35/4, B-3000, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Hermans', 'Affiliation': 'Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven - University of Leuven, Kapucijnenvoer 35/4, B-3000, Leuven, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Mouton', 'Affiliation': 'Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven - University of Leuven, Kapucijnenvoer 35/4, B-3000, Leuven, Belgium.'}, {'ForeName': 'Layth', 'Initials': 'L', 'LastName': 'Al Tmimi', 'Affiliation': 'Department of Anesthesiology, KU Leuven - University of Leuven, University Hospitals of Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Anesthesiology, KU Leuven - University of Leuven, University Hospitals of Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Detroyer', 'Affiliation': 'Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven - University of Leuven, Kapucijnenvoer 35/4, B-3000, Leuven, Belgium.'}]",BMC geriatrics,['10.1186/s12877-020-01872-6']
2479,33208099,Effect of magnesium supplementation on emergence delirium and postoperative pain in children undergoing strabismus surgery: a prospective randomised controlled study.,"BACKGROUND


The benefits of intraoperative magnesium supplementation have been reported. In this prospective, randomized study, the effects of magnesium supplementation during general anaesthesia on emergence delirium and postoperative pain in children were evaluated.
METHODS


A total of 66 children aged 2 to 5 years who underwent strabismus surgery were assigned to the magnesium or to the control group. Preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale. After anaesthesia induction, the magnesium group received an initial loading dose of 30 mg/kg magnesium sulphate over 10 min and, then, continuous infusion of 10 mg/kg per h until 10 min before the end of the surgery. The control group received an equal volume of normal saline via the same regimen. The Paediatric Anaesthesia Emergence Delirium (PAED) score, pain score, and respiratory events were assessed at the postanaesthetic care unit.
RESULTS


Data obtained from 65 children were analyzed. The PAED and pain scores of the two groups did not differ significantly. There were 26 of 33 (78.8%) and 27 of 32 (84.4%) children with emergence delirium in the control and the magnesium groups, respectively (odds ratio 0.69, 95% CI 0.19-2.44; p = 0.561). The preoperative anxiety score was not significantly correlated with the PAED score. The incidence of respiratory events during the emergence period did not differ significantly between the two groups.
CONCLUSIONS


Magnesium supplementation during anaesthesia had no significant effects on the incidence of emergence delirium or postoperative pain in children undergoing strabismus surgery.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT03132701 ). Prospectively registered May 8, 2017.",2020,The PAED and pain scores of the two groups did not differ significantly.,"['children undergoing strabismus surgery', '66 children aged 2 to 5\u2009years who underwent strabismus surgery', '65 children', 'children were evaluated']","['magnesium', 'equal volume of normal saline', 'Magnesium supplementation', 'initial loading dose of 30\u2009mg/kg magnesium sulphate', 'intraoperative magnesium supplementation', 'magnesium supplementation']","['emergence delirium', 'Paediatric Anaesthesia Emergence Delirium (PAED) score, pain score, and respiratory events', 'Preoperative anxiety', 'preoperative anxiety score', 'PAED and pain scores', 'incidence of respiratory events', 'emergence delirium and postoperative pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",66.0,0.3471,The PAED and pain scores of the two groups did not differ significantly.,"[{'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Seungeun', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Minkyoo', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea. dami0605@snu.ac.kr.'}]",BMC anesthesiology,['10.1186/s12871-020-01192-7']
2480,33208164,"Effect of nocturnal EPAP titration to abolish tidal expiratory flow limitation in COPD patients with chronic hypercapnia: a randomized, cross-over pilot study.","BACKGROUND


Tidal expiratory flow limitation (EFL T ) promotes intrinsic PEEP (PEEPi) in patients with chronic obstructive pulmonary disease (COPD). Applying non-invasive ventilation (NIV) with an expiratory positive airway pressure (EPAP) matching PEEPi improves gas exchange, reduces work of breathing and ineffective efforts. We aimed to evaluate the effects of a novel NIV mode that continuously adjusts EPAP to the minimum level that abolishes EFL T .
METHODS


This prospective, cross-over, open-label study randomized patients to one night of fixed-EPAP and one night of EFL T -abolishing-EPAP. The primary outcome was transcutaneous carbon dioxide pressure (PtcCO 2 ). Secondary outcomes were: peripheral oxygen saturation (SpO 2 ), frequency of ineffective efforts, breathing patterns and oscillatory mechanics.
RESULTS


We screened 36 patients and included 12 in the analysis (age 72 ± 8 years, FEV1 38 ± 14%Pred). The median EPAP did not differ between the EFL T -abolishing-EPAP and the fixed-EPAP night (median (IQR) = 7.0 (6.0, 8.8) cmH 2 O during night vs 7.5 (6.5, 10.5) cmH 2 O, p = 0.365). We found no differences in mean PtcCO 2  (44.9 (41.6, 57.2) mmHg vs 54.5 (51.1, 59.0), p = 0.365), the percentage of night time with PtcCO 2  > 45 mm Hg was lower (62(8,100)% vs 98(94,100)%, p = 0.031) and ineffective efforts were fewer (126(93,205) vs 261(205,351) events/hour, p = 0.003) during the EFL T -abolishing-EPAP than during the fixed-EPAP night. We found no differences in oxygen saturation and lung mechanics between nights.
CONCLUSION


An adaptive ventilation mode targeted to abolish EFL T  has the potential to reduce hypercapnia and ineffective efforts in stable COPD patients receiving nocturnal NIV.
TRIAL REGISTRATION


ClicalTrials.gov, NCT04497090. Registered 29 July 2020-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04497090 .",2020,The median EPAP did not differ between the EFL T -abolishing-EPAP and the fixed-EPAP night (median (IQR) = 7.0,"['36 patients and included 12 in the analysis (age 72\u2009±\u20098\xa0years, FEV1 38\u2009±\u200914%Pred', 'COPD patients with chronic hypercapnia', 'patients with chronic obstructive pulmonary disease (COPD', 'stable COPD patients receiving nocturnal NIV']","['Applying non-invasive ventilation (NIV) with an expiratory positive airway pressure (EPAP) matching PEEPi', 'Tidal expiratory flow limitation (EFL T ) promotes intrinsic PEEP (PEEPi', 'nocturnal EPAP titration', 'cmH', 'fixed-EPAP and one night of EFL T -abolishing-EPAP']","['peripheral oxygen saturation (SpO 2 ), frequency of ineffective efforts, breathing patterns and oscillatory mechanics', 'transcutaneous carbon dioxide pressure (PtcCO 2 ', 'median EPAP', 'percentage of night time', 'oxygen saturation and lung mechanics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1997771', 'cui_str': 'Chronic hypercapnia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0242676', 'cui_str': 'Auto-PEEP'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",36.0,0.0579796,The median EPAP did not differ between the EFL T -abolishing-EPAP and the fixed-EPAP night (median (IQR) = 7.0,"[{'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Zannin', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy. emanuela.zannin@polimi.it.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Milesi', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Porta', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Cacciatore', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Barbano', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Trentin', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Respiratory Function and Sleep Medicine Unit of the Institute of Pavia, Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfulla', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Respiratory Function and Sleep Medicine Unit of the Institute of Pavia, Pavia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Vitacca', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Raffaele L', 'Initials': 'RL', 'LastName': 'Dellacà', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy.'}]",Respiratory research,['10.1186/s12931-020-01567-x']
2481,33208180,Prospective randomized trial comparing efficacy and safety of intravenous and intra-articular tranexamic acid in total knee arthroplasty.,"BACKGROUND


Total knee arthroplasty (TKA) is associated with significant perioperative blood loss and postoperative allogenic blood transfusion. Tranexamic acid (TXA) reversibly blocks lysine binding sites on plasminogen molecules and inhibits plasmin formation. Comparisons of the efficacy and safety of intra-articular and intravenous TXA in primary TKA have not previously been reported.
METHODS


A prospective randomized trial was conducted in 150 patients who underwent TKA, and these patients were randomized into three groups. Patients in Group A were injected by intra-articular TXA according to body weight (20 mg/kg). Patients in Group B received a standard dose of intra-articular TXA (2000 mg), and those in Group C were infused with TXA according to body weight (20 mg/kg) before tourniquet deflation and again 3 h later. Baseline characteristics and data collected at blood transfusion were compared. Differences among four time points (baseline, day 0, day 2, and day 5) were carried out using ANOVA.
RESULTS


The hemoglobin levels at postoperative day 5 were 10.6 g/dL for Group A, 10.6 g/dL for Group B, and 10.7 g/dL for Group C. The drain output was 399 ml for Group A, 314 ml for Group B, and 305 ml for Group C (p = 0.03). Group C had significantly less drain output than Group A after post hoc comparisons (p = 0.05), whereas no significant difference was observed between Group A and B (p = 0.09) or between Group B and C.
CONCLUSION


The weight-adjusted dose of TXA administered intravenously significantly reduced the drain output but not the total blood loss when compared with the weight-adjusted dose of TXA administered intra-articularly. No significant difference was observed in the other parameters among the three groups.
TRIAL REGISTRATION


The Joint CUHK-NTEC CREC, CRE-2013.644-T . Registered 1 March 2014.",2020,"Group C had significantly less drain output than Group A after post hoc comparisons (p = 0.05), whereas no significant difference was observed between Group A and B (p = 0.09) or between Group B and C.
CONCLUSION


","['150 patients who underwent TKA, and these patients', 'total knee arthroplasty']","['Total knee arthroplasty (TKA', 'intra-articular and intravenous TXA', 'Tranexamic acid (TXA', 'standard dose of intra-articular TXA', 'intravenous and intra-articular tranexamic acid', 'TXA']","['total blood loss', 'hemoglobin levels', 'drain output']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",150.0,0.103123,"Group C had significantly less drain output than Group A after post hoc comparisons (p = 0.05), whereas no significant difference was observed between Group A and B (p = 0.09) or between Group B and C.
CONCLUSION


","[{'ForeName': 'Moses Man-Lung', 'Initials': 'MM', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, Hong Kong, SAR, China.'}, {'ForeName': 'Jojo Yan-Yan', 'Initials': 'JY', 'LastName': 'Kwok', 'Affiliation': 'School of Nursing, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Kwong-Yin', 'Initials': 'KY', 'LastName': 'Chung', 'Affiliation': 'Private Practice, Hong Kong, SAR, China.'}, {'ForeName': 'Kin-Wing', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Private Practice, Hong Kong, SAR, China.'}, {'ForeName': 'Kwok-Hing', 'Initials': 'KH', 'LastName': 'Chiu', 'Affiliation': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, Hong Kong, SAR, China.'}, {'ForeName': 'Wai-Wang', 'Initials': 'WW', 'LastName': 'Chau', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, SAR, China.'}, {'ForeName': 'Kevin Ki-Wai', 'Initials': 'KK', 'LastName': 'Ho', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, SAR, China. kevinho@cuhk.edu.hk.'}]",Knee surgery & related research,['10.1186/s43019-020-00079-8']
2482,33208257,"Re: Guohua Zeng, Chao Cai, Xianzhong Duan, et al. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.09.026.",,2020,,['20-40mm Renal Calculi'],"['Percutaneous Nephrolithotomy', 'Mini Percutaneous Nephrolithotomy']",[],"[{'cui': 'C0450402', 'cui_str': '40mm'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]",[],,0.0850642,,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Funada', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan; Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan. Electronic address: sfunada@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoshioka', 'Affiliation': 'Center for Innovative Research for Communities and Clinical Excellence, Fukushima Medical University, Fukushima, Japan; Department of Healthcare Epidemiology, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan.'}]",European urology,['10.1016/j.eururo.2020.11.005']
2483,33208330,Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial.,"INTRODUCTION


Bilinguals with aphasia (BWA) present varying degrees of lexical access impairment and recovery across their two languages. Because both languages may benefit from therapy, identifying the optimal target language for treatment is a current challenge for research and clinical practice. Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia. Here, we aim to determine whether BiLex can predict treatment outcomes in BWA in the treated and the untreated language and compare these outcome predictions to determine the optimal language for rehabilitation.
METHODS AND ANALYSIS


The study involves a prospective parallel-group, double-blind, randomised controlled trial. Forty-eight Spanish-English BWA will receive 20 sessions of semantic treatment for lexical retrieval deficits in one of their languages and will complete assessments in both languages prior and after treatment. Participants will be randomly assigned to an experimental group receiving treatment in the optimal language determined by the model or a control group receiving treatment in the language opposite to the model's recommendation. Primary treatment outcomes include naming probes while secondary treatment outcomes include tests tapping additional language domains. Treatment outcomes will be compared across the two groups using 2×2 mixed effect models for repeated measures Analysis of variance (ANOVA) on metrics of treatment effects commonly employed in rehabilitation studies (ie, effect size and percentage change).
ETHICS AND DISSEMINATION


All procedures included in this protocol (protocol number 29, issue date: 19 March 2019) were approved by the Boston University Charles River Campus Institutional Review Board at Boston, Massachusetts (reference number: 4492E). The results of this study will be published in peer-reviewed scientific journals and will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT02916524.",2020,"Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia.","['All procedures included in this protocol (protocol number 29, issue date: 19 March 2019) were approved by the Boston University Charles River Campus Institutional Review Board at Boston, Massachusetts (reference number: 4492E']","['BiLex', ""experimental group receiving treatment in the optimal language determined by the model or a control group receiving treatment in the language opposite to the model's recommendation""]","['rehabilitation studies (ie, effect size and percentage change', 'naming probes while secondary treatment outcomes include tests tapping additional language domains']","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",48.0,0.214576,"Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Peñaloza', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA penaloza@bu.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dekhtyar', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scimeca', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Carpenter', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Nishaat', 'Initials': 'N', 'LastName': 'Mukadam', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Kiran', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2020-040495']
2484,33208340,Randomized phase II trial of anthracycline-free and anthracycline-containing neoadjuvant carboplatin chemotherapy regimens in stage I-III triple-negative breast cancer (NeoSTOP).,"PURPOSE


Addition of carboplatin (Cb) to anthracycline chemotherapy improves pathologic complete response(pCR), and carboplatin plus taxane regimens also yield encouraging pCR rates in TNBC. Aim of NeoSTOP multisite randomized phase II trial was to assess efficacy of anthracycline-free and anthracycline-containing neoadjuvant carboplatin regimens.
EXPERIMENTAL DESIGN


Patients aged ≥18 years with stage I-III TNBC were randomized(1:1) to receive either paclitaxel(P) weekly X12 plus Cb AUC6 Q21 days X4 followed by doxorubicin/cyclophosphamide(AC) Q14 days X4 (CbP->AC, Arm-A), or to Cb AUC6 + docetaxel(D) Q21 days X6 (CbD, Arm-B). Stromal tumor-infiltrating lymphocytes (sTILs) were assessed. Primary endpoint was pCR in breast and axilla. Other endpoints included RCB, toxicity, cost, and event-free and overall survival.
RESULTS


100 patients were randomized; Arm-A ( N =48) or Arm-B ( N =52). pCR was 54% (95% CI:40%-69%) in Arm-A and 54% (95% CI:40%-68%) in Arm-B. RCB 0+I rate was 67% in both arms. Median sTILs density was numerically higher in those with pCR compared with residual disease (20% vs 5%,  P =0.25). At median follow-up of 38 months, event-free and overall survival were similar in two arms. Grade 3/4 adverse events were more common in Arm-A compared to Arm-B, with the most notable differences in neutropenia (60% vs 8%,  P <0.001) and febrile neutropenia (19% vs 0%,  P <0.001). There was one treatment-related death (Arm-A) due to acute leukemia. Mean treatment cost was lower for Arm-B compared to Arm-A ( P =0.02).
CONCLUSIONS


Two-drug CbD regimen yields pCR, RCB 0+I, and survival rates similar to the four-drug regimen of CbP->AC, but with a more favorable toxicity profile and lower treatment-associated cost.",2020,"Mean treatment cost was lower for Arm-B compared to Arm-A ( P =0.02).
","['Patients aged ≥18 years with stage', 'stage I-III triple-negative breast cancer (NeoSTOP', '100 patients']","['Q14 days X4 (CbP->AC, Arm-A), or to Cb AUC6 + docetaxel(D) Q21 days X6 (CbD, Arm-B', 'carboplatin (Cb) to anthracycline chemotherapy', 'paclitaxel(P) weekly X12 plus Cb AUC6 Q21 days X4 followed by doxorubicin/cyclophosphamide(AC', 'anthracycline-free and anthracycline-containing neoadjuvant carboplatin', 'anthracycline-free and anthracycline-containing neoadjuvant carboplatin chemotherapy regimens', 'carboplatin plus taxane']","['febrile neutropenia', 'pCR, RCB 0+I, and survival rates', 'pCR', 'pCR in breast and axilla', 'Grade 3/4 adverse events', 'event-free and overall survival', 'favorable toxicity profile', 'RCB, toxicity, cost, and event-free and overall survival', 'neutropenia', 'Stromal tumor-infiltrating lymphocytes (sTILs', 'Median sTILs density', 'Mean treatment cost']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0301039', 'cui_str': '1-chloro-3-bromopropene-1'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0879615', 'cui_str': 'Stromal tumor'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",100.0,0.162061,"Mean treatment cost was lower for Arm-B compared to Arm-A ( P =0.02).
","[{'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center psharma2@kumc.edu.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Radiation Oncology, University of Kansas Medical Center.'}, {'ForeName': 'Anne P', 'Initials': 'AP', 'LastName': ""O'Dea"", 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Nye', 'Affiliation': 'Internal Medicine, University of Kansas.'}, {'ForeName': 'Yen Y', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yoder', 'Affiliation': 'University of Kansas Cancer Center.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Staley', 'Affiliation': 'Cancer Center, University of Kansas Medical Center.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Prochaska', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Surgery, University of Kansas Medical Center.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Amin', 'Affiliation': 'Surgery, University of Kansas Medical Center.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Larson', 'Affiliation': 'General Surgery, Division of Breast Surgical Oncology, University of Kansas Medical Center.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Balanoff', 'Affiliation': 'Surgery, University of Kansas Medical Center.'}, {'ForeName': 'Manana', 'Initials': 'M', 'LastName': 'Elia', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Crane', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Sheshadri', 'Initials': 'S', 'LastName': 'Madhusudhana', 'Affiliation': 'Internal Medicine, University of Missouri-Kansas City.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sheehan', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rodriguez', 'Affiliation': 'Hematology, Hays Medical Center.'}, {'ForeName': 'Karissa', 'Initials': 'K', 'LastName': 'Finke', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Rajvi H', 'Initials': 'RH', 'LastName': 'Shah', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Satelli', 'Affiliation': 'hematology/oncology, University of Kansas Medical Center.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'Medicine, Section of Hematology and Oncology, University of Missouri-Kansas City.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Beck', 'Affiliation': 'Tammy Walker Cancer Center, Salina Regional Health Center.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McKittrick', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pluenneke', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Raja', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Venkatadri', 'Initials': 'V', 'LastName': 'Beeki', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Corum', 'Affiliation': 'Olathe Cancer Care, Olathe Medical Center.'}, {'ForeName': 'Jaimie', 'Initials': 'J', 'LastName': 'Heldstab', 'Affiliation': 'Medical Oncology, University of Kansas Medical Center.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'LaFaver', 'Affiliation': 'University of Kansas Cancer Center.'}, {'ForeName': 'Micki', 'Initials': 'M', 'LastName': 'Prager', 'Affiliation': 'University of Kansas Cancer Center.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Phadnis', 'Affiliation': 'Biostatistics and Data Science, University of Kansas Medical Center.'}, {'ForeName': 'Dinesh Pal', 'Initials': 'DP', 'LastName': 'Mudaranthakam', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center.'}, {'ForeName': 'Roy A', 'Initials': 'RA', 'LastName': 'Jensen', 'Affiliation': 'Pathology and Laboratory Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salgado', 'Affiliation': 'Pathology, GZA-ZNA.'}, {'ForeName': 'Kathan', 'Initials': 'K', 'LastName': 'Mehta', 'Affiliation': 'Internal Medicine, University of Kansas Medical Center.'}, {'ForeName': 'Qamar J', 'Initials': 'QJ', 'LastName': 'Khan', 'Affiliation': 'Inernal Medicine, University of Kansas Medical Center.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3646']
2485,33208345,Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial.,"OBJECTIVES


No immunomodulatory drug has been approved for primary Sjögren's syndrome, a systemic autoimmune disease affecting 0.1% of the population. To demonstrate the efficacy of targeting interleukin 6 receptor in patients with Sjögren's syndrome-related systemic complications.
METHODS


Multicentre double-blind randomised placebo-controlled trial between 24 July 2013 and 16 July 2018, with a follow-up of 44 weeks, involving 17 referral centres. Inclusion criteria were primary Sjögren's syndrome according to American European Consensus Group criteria and score ≥5 for the EULAR Sjögren's Syndrome Disease activity Index (ESSDAI, score of systemic complications). Patients were randomised to receive either 6 monthly infusions of tocilizumab or placebo. The primary endpoint was response to treatment at week 24. Response to treatment was defined by the combination of (1) a decrease of at least 3 points in the ESSDAI, (2) no occurrence of moderate or severe activity in any new domain of the ESSDAI and (3) lack of worsening in physician's global assessment on a Visual Numeric Scale ≥1/10, all as compared with enrolment.
RESULTS


110 patients were randomised, 55 patients to tocilizumab (mean (SD) age: 50.9 (12.4) years; women: 98.2%) and 55 patients to placebo (54.8 (10.7) years; 90.9%). At 24 weeks, the proportion of patients meeting the primary endpoint was 52.7% (29/55) in the tocilizumab group and 63.6% (35/55) in the placebo group, for a difference of -11.4% (95% credible interval -30.6 to 9.0) (Pr[Toc >Pla]=0.14).
CONCLUSION


Among patients with primary Sjögren's syndrome, the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo.
TRIAL REGISTRATION NUMBER


NCT01782235.",2020,"the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo.
","['primary Sjögren syndrome', 'mean (SD) age: 50.9 (12.4) years; women: 98.2%) and 55 patients to', '110 patients were randomised, 55 patients to', ""patients with primary Sjögren's syndrome"", '24 July 2013 and 16 July 2018, with a follow-up of 44 weeks, involving 17 referral centres', ""patients with Sjögren's syndrome-related systemic complications""]","['Interleukin 6 receptor inhibition', 'placebo', 'tocilizumab or placebo', 'tocilizumab']","[""EULAR Sjögren's Syndrome Disease activity Index (ESSDAI, score of systemic complications"", 'systemic involvement and symptoms', 'Visual Numeric Scale']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",110.0,0.774417,"the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo.
","[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Felten', 'Affiliation': 'Rheumatology, CHU Strasbourg, Centre National de Référence des maladies auto-immunes et systémiques rares Est/Sud-Ouest (RESO), Strasbourg, Alsace, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Devauchelle-Pensec', 'Affiliation': 'Rheumatology, Hospital Cavale-Blanche, Brest, Bretagne, France.'}, {'ForeName': 'Raphaèle', 'Initials': 'R', 'LastName': 'Seror', 'Affiliation': 'Rheumatology, Université Paris-Sud BU Kremlin-Bicêtre, Le Kremlin-Bicetre, Île-de-France, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Duffau', 'Affiliation': 'Internal Medicine, CHU de Bordeaux, Bordeaux, Aquitaine, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saadoun', 'Affiliation': 'University Hospital Pitié Salpêtrière, Paris, Île-de-France, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Internal Medicine, Regional and University Hospital Centre Lille Internal Medicine Service, Lille, Hauts-de-France, France.'}, {'ForeName': 'Hatron', 'Initials': 'H', 'LastName': 'Pierre Yves', 'Affiliation': 'Internal Medicine, Regional and University Hospital Centre Lille Internal Medicine Service, Lille, Hauts-de-France, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Salliot', 'Affiliation': 'Rheumatology, Regional Hospital Centre Orleans La Source Hospital, Orleans, Centre, France.'}, {'ForeName': 'Aleth', 'Initials': 'A', 'LastName': 'Perdriger', 'Affiliation': 'Rheumatology, University Hospital Centre Rennes, Rennes, Bretagne, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Morel', 'Affiliation': 'CHU Lapeyronie, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Arsène', 'Initials': 'A', 'LastName': 'Mékinian', 'Affiliation': 'Internal Medicine, Hospital Saint-Antoine, Paris, Île-de-France, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Vittecoq', 'Affiliation': 'Rheumatology, University Hospital Centre Rouen, Rouen, Normandie, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Berthelot', 'Affiliation': 'Rheumatology, Hotel Dieu, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Emanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology, CH Le Mans, Le Mans, Pays de la Loire, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Le Guern', 'Affiliation': 'Internal Médicine, Hôpital Cochin, Paris, Île-de-France, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Dieudé', 'Affiliation': 'Rheumatology, Hôpital Bichat Claude-Bernard, Paris, Île-de-France, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Larroche', 'Affiliation': 'Internal Medicine, Hospital Avicenne, Bobigny, Île-de-France, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Richez', 'Affiliation': 'Rheumatology, CHU Bordeaux GH Pellegrin, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Martin', 'Affiliation': 'Internal Medicine, CHU Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Zarnitsky', 'Affiliation': 'Rheumatology, Hôpital Jacques Monod, Montivilliers, Normandy, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blaison', 'Affiliation': 'Internal Medicine, CH Colmar, Colmar, Alsace, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Kieffer', 'Affiliation': 'Internal Medicine, CH Mulhouse, Mulhouse, Grand Est, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Internal Medicine, Sainte Blandine Hospital, Metz, Lorraine, France.'}, {'ForeName': 'Azeddine', 'Initials': 'A', 'LastName': 'Dellal', 'Affiliation': 'Rheumatology, GHI Le Raincy-Montfermeil, Montfermeil, Île-de-France, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Rist', 'Affiliation': 'Rheumatology, Regional Hospital Centre Orleans La Source Hospital, Orleans, Centre, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Andres', 'Affiliation': 'Internal Medicine, CHU Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Contis', 'Affiliation': 'Internal Medicine, CHU de Bordeaux, Bordeaux, Aquitaine, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chatelus', 'Affiliation': 'Rheumatology, CHU Strasbourg, Centre National de Référence des maladies auto-immunes et systémiques rares Est/Sud-Ouest (RESO), Strasbourg, Alsace, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Sordet', 'Affiliation': 'Rheumatology, CHU Strasbourg, Centre National de Référence des maladies auto-immunes et systémiques rares Est/Sud-Ouest (RESO), Strasbourg, Alsace, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Rheumatology, CHU Strasbourg, Centre National de Référence des maladies auto-immunes et systémiques rares Est/Sud-Ouest (RESO), Strasbourg, Alsace, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Arnold', 'Affiliation': 'DRCI, CHU Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Mira Y', 'Initials': 'MY', 'LastName': 'Tawk', 'Affiliation': 'DRCI, CHU Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Ouafaa', 'Initials': 'O', 'LastName': 'Aberkane', 'Affiliation': 'DRCI, CHU Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Holterbach', 'Affiliation': 'Public Health, Methods in Clinical Research Team, Hopitaux universitaires de Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Cacoub', 'Affiliation': 'University Hospital Pitié Salpêtrière, Paris, Île-de-France, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology, Hospital Cavale-Blanche, Brest, Bretagne, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology, Université Paris-Sud BU Kremlin-Bicêtre, Le Kremlin-Bicetre, Île-de-France, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Public Health, Methods in Clinical Research Team, Hopitaux universitaires de Strasbourg, Strasbourg, Alsace, France.'}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Rheumatology, CHU Strasbourg, Centre National de Référence des maladies auto-immunes et systémiques rares Est/Sud-Ouest (RESO), Strasbourg, Alsace, France jacques-eric.gottenberg@chru-strasbourg.fr.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218467']
2486,33208512,"Sexually transmitted infections among women randomised to depot medroxyprogesterone acetate, a copper intrauterine device or a levonorgestrel implant.","OBJECTIVES


Reproductive aged women are at risk of pregnancy and sexually transmitted infections (STI). Understanding drivers of STI acquisition, including any association with widely used contraceptives, could help us to reduce STI prevalence and comorbidities. We compared the risk of STI among women randomised to three contraceptive methods.
METHODS


We conducted a secondary analysis to assess the risk of chlamydia and gonorrhoea in a clinical trial evaluating HIV risk among 7829 women aged 16-35 randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUD) or a levonorgestrel (LNG) implant. We estimated chlamydia and gonorrhoea prevalences by contraceptive group and prevalence ratios (PR) using log-binomial regression.
RESULTS


At baseline, chlamydia and gonorrhoea prevalences were 18% and 5%, respectively. Final visit chlamydia prevalence did not differ significantly between DMPA-IM and copper IUD groups or between copper IUD and LNG implant groups. The DMPA-IM group had significantly lower risk of chlamydia compared with the LNG implant group (PR 0.83, 95% CI 0.72 to 0.95). Final visit gonorrhoea prevalence differed significantly only between the DMPA-IM and the copper IUD groups (PR 0.67, 95% CI 0.52 to 0.87).
CONCLUSIONS


The findings suggest that chlamydia and gonorrhoea risk may vary with contraceptive method use. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use.",2020,Final visit chlamydia prevalence did not differ significantly between DMPA-IM and copper IUD groups or between copper IUD and LNG implant groups.,"['Reproductive aged women are at risk of pregnancy and sexually transmitted infections (STI', '7829 women aged 16-35 randomised to']","['depot medroxyprogesterone acetate', 'intramuscular depot medroxyprogesterone acetate (DMPA-IM), a copper intrauterine device (IUD) or a levonorgestrel (LNG) implant', 'levonorgestrel implant']","['risk of chlamydia and gonorrhoea', 'risk of chlamydia', 'Final visit gonorrhoea prevalence', 'chlamydia and gonorrhoea prevalences', 'Final visit chlamydia prevalence']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3839721', 'cui_str': 'At risk of unplanned pregnancy'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0067376', 'cui_str': 'N,N-dimethyl-4-anisidine'}, {'cui': 'C0021901', 'cui_str': 'Copper Intrauterine Devices'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",7829.0,0.3152,Final visit chlamydia prevalence did not differ significantly between DMPA-IM and copper IUD groups or between copper IUD and LNG implant groups.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Deese', 'Affiliation': 'Global Public Health Impact Center, RTI International, Research Triangle Park, North Carolina, USA (formerly with FHI 360) jdeese@rti.org.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Philip', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, New York, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Global Health, International Clinical Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Setshaba Research Centre, Pretoria, South Africa.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Batting', 'Affiliation': 'Effective Care Research Unit, University of the Witwatersrand, East London, South Africa.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Vinodh A', 'Initials': 'VA', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Cheryl E', 'Initials': 'CE', 'LastName': 'Louw', 'Affiliation': 'Madibeng Centre for Research, Brits, South Africa.'}, {'ForeName': 'Maricianah', 'Initials': 'M', 'LastName': 'Onono', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Faculty of Health Sciences, Wits Reproductive Health and HIV Institute, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Smit', 'Affiliation': 'MatCH Research Unit, Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Global Health, Medicine, and Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mastro', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Nelly R', 'Initials': 'NR', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nanda', 'Affiliation': 'Product Development and Introduction, FHI 360, Durham, NC, United States.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'Wits Reproductive Health & HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Morrison', 'Affiliation': 'Behavioral, Epidemiological and Clinical Sciences, FHI 360, Durham, NC, United States.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054590']
2487,33208696,The Effect of Different Dose Regimens of Tranexamic Acid in Reducing Blood Loss in Rhinoplasty: A Prospective Randomized Controlled Study.,"Rhinoplasty is a common surgical procedure. Bleeding prevention is a crucial part of the surgery. We aimed to evaluate the different dose regimens of tranexamic acid (TXA) in reducing intraoperative blood loss among patients undergoing rhinoplasty.This prospective randomized study was performed in patients scheduled for rhinoplasty surgery between March 2019 and March 2020. The patients were divided into 3 groups containing 30 patients in each group. The patients in Group 1 received the first dose of 1 g intravenous (IV) TXA 10 minutes before the surgery, and the second dose was administered at the end of the operation. The patients in Group 2 received only a single dose of 1 g of IV TXA 10 minutes before the surgery. The patients in Group 3 did not receive medication. Demographic data were obtained through a review of patient's medical records. Preoperative and postoperative hemoglobin levels, postoperative transfusion, and complications rate were compared between the study groups.No significant differences were observed between the study groups in terms of age, gender, body mass index, American Society of Anesthesiologists scores, and the level of preoperative Hb values (P > 0.05). The mean total blood loss was lower in Group 1 than the other groups, but the difference was not statistically significant (P = 0.464).The administration of single-dose IV TXA or intermittent IV doses of TXA could decrease total blood loss in rhinoplasty, but the statistical and clinical relevance was not significant.",2020,"The mean total blood loss was lower in Group 1 than the other groups, but the difference was not statistically significant (P = 0.464).The","['Rhinoplasty', 'patients scheduled for rhinoplasty surgery between March 2019 and March 2020', 'patients undergoing rhinoplasty']","['Tranexamic Acid', 'TXA', 'tranexamic acid (TXA']","['Preoperative and postoperative hemoglobin levels, postoperative transfusion, and complications rate', 'intraoperative blood loss', 'mean total blood loss', 'total blood loss', 'Blood Loss', 'age, gender, body mass index, American Society of Anesthesiologists scores, and the level of preoperative Hb values']","[{'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0328072,"The mean total blood loss was lower in Group 1 than the other groups, but the difference was not statistically significant (P = 0.464).The","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Avci', 'Affiliation': 'Department of Ear, Nose and Throat Diseases, University of Health Sciences, Istanbul Kartal Dr Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000007247']
2488,33208723,Suture Anchor Versus Allogenic Tendon Suture in Treatment of Haglund Syndrome.,"BACKGROUND Haglund's deformity is an abnormal bony enlargement on the back of the heel. It can cause the impact of the posterior calcaneal bursa and Achilles tendon insertion, and finally result in pain. This syndrome is called Haglund syndrome. The purpose of this study was to explore the effect of the suture anchor and allogeneic tendon suture in the treatment of Haglund syndrome. MATERIAL AND METHODS We retrospectively studied 20 patients with Haglund syndrome treated from January 2015 to December 2016. The patients were randomly divided into Group 1 (the suture anchor group) and Group 2 (the allogeneic tendon group), with 10 patients in each group and an average follow-up of 32 months after surgery. The AOFAS, VAS, and Arner-Lindholm scales were used to summarize the patient follow-up results and complications. RESULTS In the 2 groups of patients, the postoperative AOFAS, VAS scores, and the Arner-Lindholm scale showed good results. However, the postoperative AOFAS score and VAS of the suture anchor group were better than those of the allogeneic tendon group, with shorter operation times. No Achilles tendon rupture or wound infection occurred during the entire postoperative period in either group. These results show the superiority of suture anchors. CONCLUSIONS The higher AOFAS and VAS score and shorter operation time in the suture anchor group suggest it is the better alternative for treatment of Haglund syndrome.",2020,"In the 2 groups of patients, the postoperative AOFAS, VAS scores, and the Arner-Lindholm scale showed good results.","['20 patients with Haglund syndrome treated from January 2015 to December 2016', 'Haglund syndrome', 'Haglund Syndrome']","['Suture Anchor Versus Allogenic Tendon Suture', 'suture anchor and allogeneic tendon suture']","['postoperative AOFAS, VAS scores', 'Achilles tendon rupture or wound infection', 'postoperative AOFAS score and VAS', 'higher AOFAS and VAS score and shorter operation time', 'AOFAS, VAS, and Arner-Lindholm scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0158444', 'cui_str': 'Juvenile osteochondrosis of foot'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",20.0,0.0169695,"In the 2 groups of patients, the postoperative AOFAS, VAS scores, and the Arner-Lindholm scale showed good results.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Deyu', 'Initials': 'D', 'LastName': 'Duan', 'Affiliation': 'Department of Orthopedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Orthopedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Ouyang', 'Affiliation': 'Department of Orthopedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.927501']
2489,33208752,Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy study: a before-after study protocol.,"Despite existing interventions, tobacco smoking and alcohol consumption during pregnancy are common. The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy. To inform development of the SAFER pregnancy intervention, two focus groups with the target population were held beforehand, with results reported here alongside the final SAFER pregnancy study protocol. In a before-after study we aim to include 66 women who are pregnant or have a wish to become pregnant and who smoke and/or consume alcohol (i.e. target population of the SAFER pregnancy intervention). The primary outcome measure is cessation of smoking and/or alcohol use at 34-38 weeks of gestation, or after six group sessions if women did not become pregnant during the study period. Secondary outcomes focus on the barriers and facilitators for implementation of the SAFER pregnancy intervention.",2020,"The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy.",['66 women who are pregnant or have a wish to become pregnant and who smoke and/or consume alcohol (i.e. target population of the SAFER pregnancy intervention'],['Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention'],"['barriers and facilitators for implementation of the SAFER pregnancy intervention', 'cessation of smoking and/or alcohol use']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",66.0,0.0411091,"The Smoke and Alcohol Free with EHealth and Rewards (SAFER) pregnancy intervention combines monthly group sessions, access to a web-based platform and incentives upon biochemically validated cessation for a maximum duration of 6 months to promote cessation of smoking and alcohol use before and during pregnancy.","[{'ForeName': 'Leonieke J', 'Initials': 'LJ', 'LastName': 'Breunis', 'Affiliation': ""Department of Obstetrics and Gynaecology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Marlou L A', 'Initials': 'MLA', 'LastName': 'de Kroon', 'Affiliation': ""Department of Obstetrics and Gynaecology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Lyzette T', 'Initials': 'LT', 'LastName': 'Laureij', 'Affiliation': ""Department of Obstetrics and Gynaecology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'de Jong-Potjer', 'Affiliation': ""Department of Obstetrics and Gynaecology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Eric A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': ""Department of Obstetrics and Gynaecology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Jasper V', 'Initials': 'JV', 'LastName': 'Been', 'Affiliation': ""Department of Obstetrics and Gynaecology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands. j.been@erasmusmc.nl.""}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00209-5']
2490,33208826,High prevalence of undiagnosed comorbidities among adolescents with obesity.,"Metabolic diseases are increasing among adolescents with obesity. Although the reported prevalence of metabolic syndrome is approximately 30% worldwide, its prevalence is largely unknown among New Zealand adolescents. Therefore, we assessed the health of adolescents with obesity (BMI ≥ 30 kg/m 2 ) enrolled in a randomised clinical trial (Gut Bugs Trial), to identify the prevalence of undiagnosed comorbidities. Assessments included anthropometry, 24-h ambulatory blood pressure monitoring, and insulin sensitivity. We report on baseline data (pre-randomisation) on 87 participants (14-18 years; 59% females), with mean BMI 36.9 ± 5.3 kg/m 2  (BMI SDS 3.33 ± 0.79). Approximately 40% of participants had undiagnosed metabolic syndrome, which was twice as common among males. Half (53%) had pre-diabetes and 92% a reduction in insulin sensitivity. Moreover, 31% had pre-hypertension/hypertension, 69% dyslipidaemia, and 25% abnormal liver function. Participants with class III obesity had a greater risk of metabolic syndrome than those with classes I/II [relative risk 1.99 (95% CI 1.19, 3.34)]. Risks for pre-hypertension/hypertension and inflammation were also greater among those with class III obesity. We identified a high prevalence of undiagnosed comorbidities among adolescents with obesity in New Zealand. As adolescent obesity tracks into adulthood, early interventions are needed to prevent progression to overt cardiometabolic diseases.",2020,"I/II [relative risk 1.99 (95% CI 1.19, 3.34)].","['adolescents with obesity (BMI\u2009≥\u200930\xa0kg/m 2 ) enrolled', '87 participants (14-18\xa0years; 59% females), with mean BMI 36.9\u2009±\u20095.3\xa0kg/m 2  (BMI SDS 3.33\u2009±\u20090.79', 'adolescents with obesity in New Zealand', 'Participants with class III obesity', 'adolescents with obesity', 'New Zealand adolescents']",[],"['risk of metabolic syndrome', 'anthropometry, 24-h ambulatory blood pressure monitoring, and insulin sensitivity', 'undiagnosed metabolic syndrome', 'pre-hypertension/hypertension', 'insulin sensitivity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C4517690', 'cui_str': '3.33'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",87.0,0.0466216,"I/II [relative risk 1.99 (95% CI 1.19, 3.34)].","[{'ForeName': 'Karen S W', 'Initials': 'KSW', 'LastName': 'Leong', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Thilini N', 'Initials': 'TN', 'LastName': 'Jayasinghe', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Brooke C', 'Initials': 'BC', 'LastName': 'Wilson', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'José G B', 'Initials': 'JGB', 'LastName': 'Derraik', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Albert', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiavaroli', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Darren M', 'Initials': 'DM', 'LastName': 'Svirskis', 'Affiliation': 'School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Beck', 'Affiliation': 'School of Sport, Exercise and Nutrition, College of Health, Massey University, Auckland, New Zealand.'}, {'ForeName': 'Cathryn A', 'Initials': 'CA', 'LastName': 'Conlon', 'Affiliation': 'School of Sport, Exercise and Nutrition, College of Health, Massey University, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Schierding', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Vatanen', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Holland', 'Affiliation': 'Department of Infectious Diseases, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand. justin.osullivan@auckland.ac.nz.'}, {'ForeName': 'Wayne S', 'Initials': 'WS', 'LastName': 'Cutfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand. w.cutfield@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-76921-6']
2491,33213488,Effects of tibial and parasacral nerve electrostimulation techniques on women with poststroke overactive bladder: study protocol for a randomized controlled trial.,"BACKGROUND


Neurogenic bladder (NB) can affect people after stroke episodes. NB features changes in the normal voiding pattern at the bladder filling and emptying phases. Overactive NB is characterized by urgency symptoms, with or without urinary incontinence, caused by NB. This disorder affects many domains of life (physical, social, psychological, domestic, sexual) that limit personal autonomy and degrade the quality of life. Among the several treatments available, the conservative physical therapy intervention through tibial nerve electrostimulation (TNES) and parasacral electrostimulation (PSES) can help improve patient conditions with a smaller number of collateral effects than those of interventions based on medication. The aim of the present study is to compare the effects of TNES and PSES techniques in women with overactive NB after stroke episodes to assess the impact of urinary incontinence in these women, on their number of incontinence episodes, daytime and nocturnal urinary frequency, and quality of life.
METHODS


This is a prospective clinical study to compare two randomized groups based on parallel and blind conditions. Forty-four women who have had a stroke episode at least 30 days before the trial and who have developed overactive NB will be recruited for the trial. All patients will be subjected to initial evaluation and randomly divided into two groups, TNES and PSES. Subsequently, the two groups will be subjected to a 12-session intervention protocol, twice a week. A new evaluation will be performed after the intervention.
DISCUSSION


The results of this study will contribute to the physiotherapeutic treatment of women with NB after a stroke episode since such results will add information about the benefits of this treatment, urinary control, and the improvements in the quality of life of these women.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials (REBEC) RBR-2bn2z4 . Registered on December 11, 2018.",2020,Forty-four women who have had a stroke episode at least 30 days before the trial and who have developed overactive NB will be recruited for the trial.,"['women with poststroke overactive bladder', 'women with overactive NB after stroke episodes', 'Forty-four women who have had a stroke episode at least 30\u2009days before the trial and who have developed overactive NB will be recruited for the trial']","['tibial and parasacral nerve electrostimulation techniques', 'TNES and PSES techniques', 'TNES and PSES', 'conservative physical therapy intervention through tibial nerve electrostimulation (TNES) and parasacral electrostimulation (PSES']","['incontinence episodes, daytime and nocturnal urinary frequency, and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0443272', 'cui_str': 'Overactive'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C4324586', 'cui_str': 'Nocturnal urinary frequency'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",44.0,0.0813789,Forty-four women who have had a stroke episode at least 30 days before the trial and who have developed overactive NB will be recruited for the trial.,"[{'ForeName': 'Thais Alves', 'Initials': 'TA', 'LastName': 'Candido', 'Affiliation': 'Federal University of Uberlândia, R. Benjamin Constant, 1286 - Nossa Sra. Aparecida, Uberlândia, MG, 38400-678, Brazil.'}, {'ForeName': 'Bruna Miranda', 'Initials': 'BM', 'LastName': 'Ribeiro', 'Affiliation': 'Federal University of Uberlândia, R. Benjamin Constant, 1286 - Nossa Sra. Aparecida, Uberlândia, MG, 38400-678, Brazil.'}, {'ForeName': 'Cristiane Rodrigues Cardoso', 'Initials': 'CRC', 'LastName': 'de Araújo', 'Affiliation': 'Federal University of Uberlândia, R. Benjamin Constant, 1286 - Nossa Sra. Aparecida, Uberlândia, MG, 38400-678, Brazil.'}, {'ForeName': 'Rogério de Melo Costa', 'Initials': 'RMC', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Uberlândia, R. Benjamin Constant, 1286 - Nossa Sra. Aparecida, Uberlândia, MG, 38400-678, Brazil.'}, {'ForeName': 'Ana Paula Magalhães', 'Initials': 'APM', 'LastName': 'Resende', 'Affiliation': 'Federal University of Uberlândia, R. Benjamin Constant, 1286 - Nossa Sra. Aparecida, Uberlândia, MG, 38400-678, Brazil.'}, {'ForeName': 'Vanessa Santos', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': 'Federal University of Uberlândia, R. Benjamin Constant, 1286 - Nossa Sra. Aparecida, Uberlândia, MG, 38400-678, Brazil. vanessabaldon@ufu.br.'}]",Trials,['10.1186/s13063-020-04856-4']
2492,33213492,"Short-term effect of kinesiology taping on pain, functional disability and lumbar proprioception in individuals with nonspecific chronic low back pain: a double-blinded, randomized trial.","BACKGROUND


This study aimed to evaluate the effect of kinesiology taping (KT) on lumbar proprioception, pain, and functional disability in individuals with nonspecific chronic low back pain (CLBP).
METHODS


Thirty individuals with nonspecific CLBP participated in this double-blinded, randomized clinical trial from July 2017 to September 2018. The participants were randomized into two groups: KT (n = 15) and placebo group (n = 15). KT was applied with 15-25% tension for 72 h, and placebo taping was used without tension. Lumbar repositioning error was measured by a bubble inclinometer at three different angles (45° and 60° flexion, and 15° extension) in upright standing. Pain and disability were assessed by the Short-Form McGill Pain Questionnaire and Oswestry Disability Index, respectively. All measurements were recorded at baseline and 3 days after taping.
RESULTS


Pain and disability scores reduced 3 days after taping in the KT group with large effect sizes (p < 0.05). Only the total score of pain was significantly different between the groups 3 days after taping and improved more in the KT group with a large effect size (p < 0.05). However, lumbar repositioning errors were similar between the groups after 3 days (p > 0.05). Also, only constant error of 15° extension showed a moderate correlation with disability (r = 0.39, p = 0.02).
CONCLUSION


KT can decrease pain and disability scores after 3 days of application. Although placebo taping can reduce pain, the effect of KT is higher than placebo taping. The findings do not support the therapeutic effect of KT and placebo taping as a tool to enhance lumbar proprioception in patients with nonspecific CLBP.
TRIAL REGISTRATION


The study prospectively registered on 21.05.2018 at the Iranian Registry of Clinical Trials: IRCT20090301001722N20 .",2020,"RESULTS


Pain and disability scores reduced 3 days after taping in the KT group with large effect sizes (p < 0.05).","['individuals with nonspecific chronic low back pain', 'individuals with nonspecific chronic low back pain (CLBP', 'Thirty individuals with nonspecific CLBP participated in this double-blinded, randomized clinical trial from July 2017 to September 2018', 'patients with nonspecific CLBP']","['kinesiology taping', 'placebo', 'placebo taping', 'KT and placebo', 'kinesiology taping (KT', 'KT']","['lumbar repositioning errors', 'lumbar proprioception', 'total score of pain', 'Lumbar repositioning error', 'Pain and disability scores', 'pain and disability scores', 'lumbar proprioception, pain, and functional disability', 'Pain and disability', 'pain', 'pain, functional disability and lumbar proprioception', 'Short-Form McGill Pain Questionnaire and Oswestry Disability Index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",30.0,0.519787,"RESULTS


Pain and disability scores reduced 3 days after taping in the KT group with large effect sizes (p < 0.05).","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, (TUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Hadian Rasanani', 'Affiliation': 'Postgraduate Department, School of Rehabilitation, Tehran University of Medical Sciences, International, Brain and Spinal Injury Research Center (BASIR), Institute of Neuroscirnce, P.O. Box: 111551683, Tehran, Iran. hadianrs@sina.tums.ac.ir.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Ghotbi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, (TUMS), Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Olyaei', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, (TUMS), Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bozorgmehr', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rasouli', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00349-y']
2493,33213494,Does subcutaneous administration of recombinant human erythropoietin increase thrombotic events in total hip arthroplasty? A prospective thrombelastography analysis.,"BACKGROUND


Anemia is one of severe complications in the perioperative period of total hip arthroplasty (THA). Erythropoietin (EPO) has been considered to improve patients' anemia state, but its efficiency and safety remains controversial.
METHODS


A total of 152 patients who underwent total hip arthroplasty from January 2017 to March 2019 were randomized to 2 groups. Recombinant human erythropoietin (rHu-EPO) group was treated with rHu-EPO subcutaneous injection 10000 IU after operation and once daily in the next week, while control group was treated with none extra treatment. Routine hematologic examination and thrombelastography (TEG) performed at different time point respectively. Doppler ultrasound for bilateral lower limbs was performed 1 day before surgery and 7 days after surgery. Auxiliary examination outcomes, blood transfusions outcomes, and postoperative complications were recorded as assessment indicators.
RESULTS


The difference in the relevant indexes of traditional coagulation and TEG values between two groups were not significantly. No significant difference was observed in the incidence of thromboembolism events and other complications between two groups during postoperative period. The amount of intraoperative blood loss was similar between the two groups. However, the postoperative use and dosage of allogeneic blood in the rHu-EPO group were lower than those in the control group. The hemoglobin and hematocrit level in the rHu-EPO group were higher than that in the control group after surgery.
CONCLUSION


Postoperative subcutaneous injection of rHu-EPO can improve hematological anemia-related parameters, reduce the use and dosage of allogeneic blood transfusions (ABTs), and has no significant influence on the formation of thrombosis and other complications in patients undergoing total hip arthroplasty in short term.",2020,"The hemoglobin and hematocrit level in the rHu-EPO group were higher than that in the control group after surgery.
","['total hip arthroplasty (THA', '152 patients who underwent total hip arthroplasty from January 2017 to March 2019', 'total hip arthroplasty', 'patients undergoing total hip arthroplasty in short term']","['Recombinant human erythropoietin (rHu-EPO', 'recombinant human erythropoietin', 'rHu-EPO', 'Erythropoietin (EPO', 'rHu-EPO subcutaneous injection', 'Doppler ultrasound']","['Auxiliary examination outcomes, blood transfusions outcomes, and postoperative complications', 'thrombotic events', 'incidence of thromboembolism events and other complications', 'postoperative use and dosage of allogeneic blood', 'traditional coagulation and TEG values', 'hemoglobin and hematocrit level', 'intraoperative blood loss', 'Routine hematologic examination and thrombelastography (TEG']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}]",152.0,0.0167271,"The hemoglobin and hematocrit level in the rHu-EPO group were higher than that in the control group after surgery.
","[{'ForeName': 'Ru-Xin', 'Initials': 'RX', 'LastName': 'Ruan', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Chao-Wen', 'Initials': 'CW', 'LastName': 'Bai', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Chao-Ran', 'Initials': 'CR', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Xing-Chen', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Zheng-Ya', 'Initials': 'ZY', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China. thindy1980@163.com.'}, {'ForeName': 'Kai-Jin', 'Initials': 'KJ', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopaedics, The Affiliated Hospital of Xuzhou Medical University, No. 99, Huaihai West Road, Xuzhou, Jiangsu Province, 221000, China. kaijinguo@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-02083-w']
2494,33213506,Developing and testing the effectiveness of a novel online integrated treatment for problem gambling and tobacco smoking: a protocol for an open-label randomized controlled trial.,"BACKGROUND


Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e. targeting both gambling and tobacco smoking simultaneously), accessible, and evidence based.
METHODS


The aim of this two-arm open-label randomized controlled trial is to examine the effectiveness of an online, self-guided integrated treatment for problem gambling and tobacco smoking. A target sample of 214 participants will be recruited and be randomized into either an 8-week integrated or gambling only control condition. Both conditions will consist of seven online modules following cognitive behavioural therapy and motivational interviewing principles. Our three primary outcomes are (1) the number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities. Secondary outcomes include gambling disorder symptoms, cigarette use, and nicotine dependence symptoms. Assessments will be completed at baseline, at completion (i.e. 8 weeks from baseline), and at follow-up (i.e. 24 weeks from baseline). Generalized linear mixed modelling will be used to evaluate our primary and secondary outcomes. We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention. We further hypothesize that reductions in smoking will mediate these group differences.
DISCUSSION


The rates of problem gambling and tobacco smoking are high in North America; yet, the treatment options for both are limited, with no integrated treatments available. If supported, our pilot study will be a cost-effective and accessible way to improve treatments for co-occurring problem gambling and tobacco use.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03614884 . Registered on August 3, 2019.",2020,We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention.,"['problem gambling and tobacco smoking', '214 participants', 'North American adults']","['8-week integrated or gambling only control condition', 'novel online integrated treatment', 'online, self-guided integrated treatment']","['rates of problem gambling and tobacco smoking', 'number of days gambled, (2) money spent on gambling activities, and (3) time spent in gambling activities', 'gambling disorder symptoms, cigarette use, and nicotine dependence symptoms']","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}]",214.0,0.140027,We expect that participants receiving online integrated treatment will show larger reductions in gambling relative to those receiving a control gambling only intervention.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bilevicius', 'Affiliation': 'Department of Psychology, University of Manitoba, 190 Dysart Rd, Winnipeg, MB, R3T 2N2, Canada.'}, {'ForeName': 'Alanna', 'Initials': 'A', 'LastName': 'Single', 'Affiliation': 'Department of Psychology, University of Manitoba, 190 Dysart Rd, Winnipeg, MB, R3T 2N2, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baumgartner', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Konradstrasse 32, CH-8031, Zurich, Switzerland.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Bui', 'Affiliation': 'Department of Psychology, University of Manitoba, 190 Dysart Rd, Winnipeg, MB, R3T 2N2, Canada.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Kempe', 'Affiliation': 'Department of Psychology, University of Manitoba, 190 Dysart Rd, Winnipeg, MB, R3T 2N2, Canada.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Schaub', 'Affiliation': 'Swiss Research Institute for Public Health and Addiction, University of Zurich, Konradstrasse 32, CH-8031, Zurich, Switzerland.'}, {'ForeName': 'Sherry H', 'Initials': 'SH', 'LastName': 'Stewart', 'Affiliation': ""Departments of Psychiatry and Psychology & Neuroscience, Dalhousie University, Abbie J Lane Building, 8th floor, 5909 Veteran's Memorial Lane, Halifax, NS, B3H 3A7, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': ""Peter Boris Centre for Addictions Research McMaster University/St. Joseph's Healthcare Hamilton, 1280 Main St West, Hamilton, ON, L8S 4L8, Canada.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University D NW, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Wardell', 'Affiliation': 'Department of Psychiatry, University of Toronto, 250 College Street, Toronto, ON, M5T 1R8, Canada.'}, {'ForeName': 'Roisin', 'Initials': 'R', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychology, Concordia University, 7141 Sherbrooke W., Montreal, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Read', 'Affiliation': 'Department of Psychology, University of Buffalo, 231 Park Hall, Buffalo, NY, 14260-4110, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hadjistavropoulos', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sundstrom', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Keough', 'Affiliation': 'Department of Psychology, York University, 4700 Keele St, North York, ON, M3J 1P3, Canada. keoughmt@yorku.ca.'}]",Trials,['10.1186/s13063-020-04867-1']
2495,33214093,Evaluating the effects of Intravenous Immunoglobulin (IVIg) on the management of severe COVID-19 cases: A randomized controlled trial.,"BACKGROUND


The newly discovered coronavirus has turned into coronavirus disease 2019 (COVID-19) pandemic and it rages at an unprecedented rate. Considering the findings of previous studies on the use of Intravenous Immunoglobulin (IVIg) for treating severe H 1 N 1  infection and the satisfying results for reducing viral load and mortality, this study aimed to investigate the potential usefulness of IVIg for the management of severe cases.
METHODS


In this randomized controlled trial, 84 patients were included: 52 in the IVIg group and 32 in the control group. The intervention group received IVIg at a dose of 400 mg/kg, IV, daily for three days. Both groups received hydroxychloroquine, lopinavir/ritonavir and supportive care. The demographic data, mortality rate, the need for mechanical ventilation, length of stay in hospital and in Intensive Care Unit (ICU), and imaging findings were recorded and compared in terms of the mentioned factors.
RESULTS


The mean time from admission to IVIg initiation was 3.84 ± 3.35 days. There was no significant difference between the two groups in terms of mortality rate (P-value = 0.8) and the need for mechanical ventilation (P-value = 0.39). The length of hospital stay was significantly lower for the control group than that of the intervention group (P-value = 0.003). There was a significant positive relationship between the time from hospital admission to IVIg initiation and the length of stay in the hospital and ICU among the survivors (P-value < 0.001 and =0.01, respectively).
CONCLUSIONS


Our findings did not support the use of IVIg in combination with hydroxychloroquine and lopinavir/ritonavir in treatment of severe COVID-19 cases.",2020,There was no significant difference between the two groups in terms of mortality rate (P-value = 0.8) and the need for mechanical ventilation (P-value = 0.39).,"['84 patients were included: 52 in the IVIg group and 32 in the control group', 'severe COVID-19 cases']","['hydroxychloroquine and lopinavir/ritonavir', 'hydroxychloroquine, lopinavir/ritonavir and supportive care', 'Intravenous Immunoglobulin (IVIg']","['mortality rate', 'length of hospital stay', 'mean time from admission to IVIg initiation', 'time from hospital admission to IVIg initiation and the length of stay in the hospital and ICU', 'need for mechanical ventilation', 'demographic data, mortality rate, the need for mechanical ventilation, length of stay in hospital and in Intensive Care Unit (ICU), and imaging findings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",84.0,0.118499,There was no significant difference between the two groups in terms of mortality rate (P-value = 0.8) and the need for mechanical ventilation (P-value = 0.39).,"[{'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Tabarsi', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Centre, National Research Institute for Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Barati', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamaati', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Haseli', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Marjani', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Moniri', 'Affiliation': 'Virology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abtahian', 'Affiliation': 'Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Dastan', 'Affiliation': 'Ernest and Julio Gallo Management Program, School of Engineering University of California, Merced, United States.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Yousefian', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Raha', 'Initials': 'R', 'LastName': 'Eskandari', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Saffaei', 'Affiliation': 'Student Research Committee, Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Monjazebi', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolbaset', 'Initials': 'A', 'LastName': 'Vahedi', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), Masih Daneshvari Hospital, Shahid Beheshti Medical University, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: fzh.dastan@gmail.com.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107205']
2496,33214094,Gene and systemic inflammatory effects and neuroendocrine response in surgical patients anesthetized with desflurane-nitrous oxide or desflurane-nitrous oxide-free: A randomized trial.,"There is growing interest in assessing possible immunotoxicological effects in anesthetized patients. There are controversial findings concerning the effect of nitrous oxide (N 2 O) anesthetic gas effect on inflammatory response. We tested the hypothesis that N 2 O associated with desflurane (inhalational anesthetic) was likely to worsen neuro-immune-endocrine effects when compared with desflurane alone in this randomized trial. The primary endpoint of this study was to evaluate the systemic proinflammatory interleukin (IL)-6, and the secondary endpoints included other systemic (IL-1β, TNF-α, IL-8, IL-10, IL-17A and high-sensitivity C-reactive protein - hs-CRP) and genetic inflammatory markers (NF-kB, IL-6 and COX-2) as well as hormones (adrenocorticotropic hormone, cortisol and prolactin) comparing patients undergoing minor surgery with or without N 2 O-desflurane. As a second aim, we assessed whether there were changes in the neuro-immune-endocrine profiles within each group. Blood samples were collected before anesthesia, 90 min after anesthesia induction, and the day after surgery. We assessed serum cytokines using a cytometric bead array and hs-CRP by chemiluminescent immunoassay. Expression of three proinflammatory transcripts was assessed by real-time quantitative polymerase chain reaction, and neuroendocrine hormones were detected by chemiluminescent microparticle immunoenzymatic assay. There were no significant between-group differences for any analyzed biomarkers. However, there was a significant increase in: (a) systemic IL-6 and hs-CRP values one day after surgery in both groups and (b) prolactin levels in the intraoperative period compared to baseline and postoperative period levels for both groups. In conclusion, N 2 O does not impair the inflammatory profile and neuroendocrine response compared to patients who receive only desflurane anesthesia.",2020,"However, there was a significant increase in: (a) systemic IL-6 and hs-CRP values one day after surgery in both groups and (b) prolactin levels in the intraoperative period compared to baseline and postoperative period levels for both groups.","['surgical patients anesthetized with', 'anesthetized patients']","['desflurane', 'desflurane (inhalational anesthetic', 'nitrous oxide', 'desflurane anesthesia', 'desflurane-nitrous oxide or desflurane-nitrous oxide-free']","['prolactin levels', 'systemic proinflammatory interleukin (IL)-6, and the secondary endpoints included other systemic (IL-1β, TNF-α, IL-8, IL-10, IL-17A and high-sensitivity C-reactive protein - hs-CRP) and genetic inflammatory markers (NF-kB, IL-6 and COX-2) as well as hormones (adrenocorticotropic hormone, cortisol and prolactin', 'inflammatory response', ' (a) systemic IL-6 and hs-CRP values', 'inflammatory profile and neuroendocrine response']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C1565860', 'cui_str': 'PTGS2 protein, human'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027912', 'cui_str': 'Neuroendocrine System'}]",,0.181315,"However, there was a significant increase in: (a) systemic IL-6 and hs-CRP values one day after surgery in both groups and (b) prolactin levels in the intraoperative period compared to baseline and postoperative period levels for both groups.","[{'ForeName': 'Nayara M', 'Initials': 'NM', 'LastName': 'Arruda', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Leandro G', 'Initials': 'LG', 'LastName': 'Braz', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Nogueira', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Kátina M', 'Initials': 'KM', 'LastName': 'Souza', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Aline G', 'Initials': 'AG', 'LastName': 'Aun', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Lídia R', 'Initials': 'LR', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Biostatistics, Institute of Biosciences, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'José Reinaldo C', 'Initials': 'JRC', 'LastName': 'Braz', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil.'}, {'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Braz', 'Affiliation': 'GENOTOX Laboratory, Department of Anesthesiology, Botucatu Medical School, São Paulo State University - UNESP, Botucatu, Brazil. Electronic address: mariana.braz@unesp.br.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107163']
2497,33208995,Efficacy of Topical 5% 5-Fluorouracil with Needling versus 5% 5-Fluorouracil Alone in Stable Vitiligo: A Randomized Controlled Study.,"Background


Vitiligo is a chronic disease of great cosmetic concern presenting with depigmented macules and patches. It is often recalcitrant to medical treatment.
Aim


The aim of the study was to study the efficacy and safety of topical 5% 5-fluorouracil with needling versus topical 5% 5-fluorouracil alone in stable vitiligo.
Materials and Methods


This interventional prospective study was conducted from July 2018 to June 2019. Total of 60 patients, with stable vitiligo of age older than 10 years, were randomly assigned into two groups of 30 patients each. Group A was treated with needling followed by topical 5% 5-fluorouracil over vitiligo patches. The procedure was performed every 2 weeks for 3 months. Group B was treated with topical 5% 5-fluorouracil alone. Clinical improvement was assessed monthly till 6 months by serial clinical photographs and grading score.
Results


Initiation of repigmentation started at 1 month in 76 patches (65%) in Group A, whereas in group B, it was seen in 45 patches (38.7%), which was statistically significant ( P  = 0.0001). Excellent improvement (>75% repigmentation) was noted in 55 patches (47%) in Group A as compared to 5 patches (4.3%) in group B at the end of 6 months ( P  = 0.03).
Conclusion


Needling with 5% 5-fluorouracil appears to be simple, safe, and effective treatment in vitiligo. It can be used in poor responders to conventional therapy.",2020,"Excellent improvement (>75% repigmentation) was noted in 55 patches (47%) in Group A as compared to 5 patches (4.3%) in group B at the end of 6 months ( P  = 0.03).
","['July 2018 to June 2019', 'stable vitiligo', 'Total of 60 patients, with stable vitiligo of age older than 10 years', 'Stable Vitiligo']","['5-fluorouracil', 'Topical 5% 5-Fluorouracil with Needling versus 5% 5-Fluorouracil Alone', 'needling followed by topical 5% 5-fluorouracil', 'topical 5% 5-fluorouracil with needling versus topical 5% 5-fluorouracil', 'topical 5% 5-fluorouracil']",['efficacy and safety'],"[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0234923,"Excellent improvement (>75% repigmentation) was noted in 55 patches (47%) in Group A as compared to 5 patches (4.3%) in group B at the end of 6 months ( P  = 0.03).
","[{'ForeName': 'Fatima T', 'Initials': 'FT', 'LastName': 'Zahra', 'Affiliation': 'Department of Dermatology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU), Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Adil', 'Affiliation': 'Department of Dermatology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU), Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Syed S', 'Initials': 'SS', 'LastName': 'Amin', 'Affiliation': 'Department of Dermatology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU), Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Mohd', 'Initials': 'M', 'LastName': 'Mohtashim', 'Affiliation': 'Department of Dermatology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU), Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Roopal', 'Initials': 'R', 'LastName': 'Bansal', 'Affiliation': 'Department of Dermatology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU), Aligarh, Uttar Pradesh, India.'}, {'ForeName': 'Hania Q', 'Initials': 'HQ', 'LastName': 'Khan', 'Affiliation': 'Department of Dermatology, Jawaharlal Nehru Medical College (JNMC), Aligarh Muslim University (AMU), Aligarh, Uttar Pradesh, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_12_20']
2498,33209019,"Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study.","Purpose


Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limited. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine as adjuvant therapy for patients with AECOPD.
Methods


This was a randomized, double-blind, placebo-controlled study of 378 participants from eight centers in China. Participants were randomly assigned to receive 10 g of Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo, two times per day, for 14 days, in addition to conventional medicine. Participants were followed up for 84 days after the treatment. The primary end point was the COPD assessment test (CAT) score. Secondary end points included the Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO). We also assessed treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation.
Results


The between-group difference in the change from baseline for CAT on day 14 (end of treatment) was -2.11 (95% confidence interval [CI], -3.198 to -1.050; P<0.001), exceeding the minimal clinically important difference. The mMRC and COPD-PRO scores were lower in the intervention group compared to the control group (between-group difference in the change from baseline, -0.28; 95% CI, -0.48 to -0.08; P=0.007 and -2.51; 95% CI, -4.087 to -0.929; P=0.002, respectively) on day 14. The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, -1.21days; 95% CI, -2.041 to -0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015). Significant differences in the number of treatment failures or successes, deaths, and intubation were not observed. The difference in safety variables and adverse events between the two groups was not observed.
Conclusion


Chinese herbal medicine appears to be safe and beneficial for AECOPD and can be considered a complementary treatment for patients with AECOPD.",2020,"The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, -1.21days; 95% CI, -2.041 to -0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015).","['chronic obstructive pulmonary disease (AECOPD', 'patients with AECOPD', '378 participants from eight centers in China', 'Acute Exacerbations of COPD']","['Chinese Herbal Medicine', 'Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo', 'placebo', 'Placebo', 'Chinese herbal medicine']","['treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation', 'safety variables and adverse events', 'efficacy and safety', 'Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO', 'COPD assessment test (CAT) score', 'number of treatment failures or successes, deaths, and intubation', 'number of exacerbations', 'mMRC and COPD-PRO scores', 'shorter duration of hospital stay']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",378.0,0.531515,"The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, -1.21days; 95% CI, -2.041 to -0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015).","[{'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, People's Republic of China.""}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, People's Republic of China.""}, {'ForeName': 'Huanrong', 'Initials': 'H', 'LastName': 'Ruan', 'Affiliation': ""The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, People's Republic of China.""}, {'ForeName': 'Yimei', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': ""The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, People's Republic of China.""}, {'ForeName': 'Zikai', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People's Republic of China.""}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Haici Hospital of Qingdao, Qingdao, People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Zhengzhou People's Hospital, Zhengzhou, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': ""Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Nanyang City Center Hospital, Nanyang, People's Republic of China.""}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S276082']
2499,33209056,Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial.,"Purpose


Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. This study aimed to compare the efficacy of intravenous morphine versus serratus anterior plane block (SAPB) and erector spinae plane block (ESPB) in breast cancer surgeries.
Patients and Methods


Seventy-five breast cancer patients undergoing modified radical mastectomy from January 2020 to June 2020 were randomly allocated into 3 groups; the morphine group received morphine 0.1 mg/kg, the SAPB group received ultrasound-guided SAPB with 25 mL bupivacaine 0.25% and the ESPB group received ultrasound-guided ESPB with 25 mL bupivacaine 0.25%. A visual analogue scale (VAS) 0-10 was used to evaluate pain postoperatively, where 0 denotes no pain and 10 worst pain. If any patient in the 3 studied groups reported breakthrough pain with VAS ≥ 4 then a bolus of 3 mg morphine was given.
Results


There was no difference in VAS scores between the 3 groups postoperatively. Morphine consumption was higher in the morphine group (9.19 ± 2.32 mg) than the SAPB group (4.00 ± 1.55 mg) and the ESPB group (4.20 ± 1.64 mg), respectively. First time to receive postoperative morphine was significantly longer for the ESPB and SAPB groups than the morphine group (20.40 ± 4.98 hours), (19.00 ± 5.9 hours), (5.00 ± 4.62 hours), respectively. Intraoperative hemodynamics and fentanyl consumption showed no difference between groups, whereas postoperative mean arterial blood pressure values at 2 and 4 hours were higher in the morphine group. Ramsay sedation score and postoperative nausea and vomiting values in the post anesthesia care unit were higher for the morphine group compared to the SAPB and ESPB groups. No complications related to the blocks were reported.
Conclusion


SAPB and ESPB can be used as an effective and safe alternative to opioids with fewer side effects in breast cancer patients undergoing modified radical mastectomy.
Trial Registration


This trial was prospectively registered at Clinical Trials.gov on 22 January 2020 with registration number NCT04248608 (https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009JS5&selectaction=Edit&uid=U0004LIG&ts=7&cx=-81xkwa).",2020,Ramsay sedation score and postoperative nausea and vomiting values in the post anesthesia care unit were higher for the morphine group compared to the SAPB and ESPB groups.,"['Patients and Methods\n\n\nSeventy-five breast cancer patients undergoing modified radical mastectomy from January 2020 to June 2020', 'breast cancer patients undergoing modified radical mastectomy', 'breast cancer surgeries', '22 January 2020 with registration number NCT04248608 (https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009JS5&selectaction=Edit&uid=U0004LIG&ts=7&cx=-81xkwa', 'Breast Cancer Surgeries']","['morphine group received morphine 0.1 mg/kg, the SAPB group received ultrasound-guided SAPB with 25 mL bupivacaine', 'ESPB group received ultrasound-guided ESPB with 25 mL bupivacaine', 'postoperative morphine', 'morphine versus serratus anterior plane block (SAPB) and erector spinae plane block (ESPB', 'ESPB', 'morphine', 'SAPB']","['Ramsay sedation score and postoperative nausea and vomiting values', 'VAS scores', 'Intraoperative hemodynamics and fentanyl consumption', 'breakthrough pain', 'Morphine consumption', 'postoperative mean arterial blood pressure values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",75.0,0.0680166,Ramsay sedation score and postoperative nausea and vomiting values in the post anesthesia care unit were higher for the morphine group compared to the SAPB and ESPB groups.,"[{'ForeName': 'Walaa Y', 'Initials': 'WY', 'LastName': 'Elsabeeny', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nahla N', 'Initials': 'NN', 'LastName': 'Shehab', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Wadod', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mostafa A', 'Initials': 'MA', 'LastName': 'Elkady', 'Affiliation': 'Department of Anesthesia and Pain Management, National Cancer Institute, Cairo University, Cairo, Egypt.'}]",Journal of pain research,['10.2147/JPR.S274808']
2500,33209058,Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I-II Trial.,"Purpose


A concomitant boost (CB) in patients treated with postoperative radiotherapy after conservative surgery of invasive breast cancer (BC) has been suggested for treatment time reduction and therapy intensification. The aim of this analysis was to assess long-term tolerability of a CB in patients treated with postoperative intensity Modulated Accelerated RAdiotherapy (MARA).
Patients and Methods


In this phase I-II trial, 321 patients with intermediate-high risk BC (pT1-4 with at least one of the following characteristics: pre or perimenopausal status, pN2-3, positive or close margins) were enrolled. Patients were treated with forward-planned intensity modulated radiotherapy (IMRT) and CB. A total dose of 50 Gy (2 Gy/fraction) and 60 Gy (2.4 Gy/fraction) was prescribed to the whole breast and the tumor bed, respectively. The potential impact of hypertension, diabetes, smoking habit, alcohol consumption, chemotherapy, and hormone therapy on both skin and subcutaneous late toxicity-free survival (LTFS) was evaluated. Survival curves were calculated using the Kaplan-Meier method.
Results


Median follow-up was 52 months (range: 3-115). Regional node irradiation, adjuvant chemotherapy and hormonal therapy were prescribed to 29.3%, 65.4% and 81.0% of patients, respectively. Five-year G2 and G3 skin LTFS were 95.6% and 100.0%, respectively. Five-year G2 and G3 subcutaneous LTFS were 80.0% and 98.6%, respectively. Only diabetes showed a significant correlation with worse G3 subcutaneous LTFS (p: 0.024). Five-year loco-regional control, metastasis-free survival, disease-free survival, and overall survival were 98.0%, 91.8%, 89.7% and 96.3%, respectively.
Conclusion


IMRT combined with CB was associated with a low risk of > G2 late toxicities (0.0% and 1.4% for skin and subcutaneous tissue, respectively). The cumulative actuarial incidence of local recurrences was 2.0% despite the exclusion of low-risk patients. Our results suggest that CB is safe and effective in patients with intermediate-high risk BC.
Trial Registration


ClinicalTrials.gov: NCT03471741.",2020,"Five-year loco-regional control, metastasis-free survival, disease-free survival, and overall survival were 98.0%, 91.8%, 89.7% and 96.3%, respectively.
","['patients treated with postoperative intensity Modulated Accelerated RAdiotherapy (MARA', '321 patients with intermediate-high risk BC (pT1-4 with at least one of the following characteristics: pre or perimenopausal status, pN2-3, positive or close margins) were enrolled', 'patients treated with postoperative radiotherapy after conservative surgery of invasive breast cancer (BC', 'patients with intermediate-high risk BC']","['CB', 'concomitant boost (CB', 'forward-planned intensity modulated radiotherapy (IMRT) and CB', 'Intensity-Modulated Radiotherapy with Concomitant Boost', 'Regional node irradiation, adjuvant chemotherapy and hormonal therapy']","['Survival curves', 'metastasis-free survival, disease-free survival, and overall survival', 'hypertension, diabetes, smoking habit, alcohol consumption, chemotherapy, and hormone therapy on both skin and subcutaneous late toxicity-free survival (LTFS', 'low risk of > G2 late toxicities', 'cumulative actuarial incidence of local recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332398', 'cui_str': 'pN2 category'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1269795', 'cui_str': 'Margin closest to tumor'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",321.0,0.213965,"Five-year loco-regional control, metastasis-free survival, disease-free survival, and overall survival were 98.0%, 91.8%, 89.7% and 96.3%, respectively.
","[{'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Macchia', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Cilla', 'Affiliation': 'Medical Physics Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Milly', 'Initials': 'M', 'LastName': 'Buwenge', 'Affiliation': 'Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Zamagni', 'Affiliation': 'Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Ammendolia', 'Affiliation': 'Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Zamagni', 'Affiliation': 'Addarii Medical Oncology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Giovanni P', 'Initials': 'GP', 'LastName': 'Frezza', 'Affiliation': 'Radiation Oncology Unit, Bellaria Hospital, Bologna, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Valentini', 'Affiliation': 'Dipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Radioterapia, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Deodato', 'Affiliation': 'Radiotherapy Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy.'}, {'ForeName': 'Alessio G', 'Initials': 'AG', 'LastName': 'Morganti', 'Affiliation': 'Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.'}]",Breast cancer (Dove Medical Press),['10.2147/BCTT.S261587']
2501,32894251,"Feasibility, Reliability, and Value of Remote Video-Based Trial Visits in Parkinson's Disease.","BACKGROUND


There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic.
OBJECTIVE


To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease.
METHODS


We invited individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits.
RESULTS


We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81-0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43-0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely.
CONCLUSION


Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson's disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.",2020,"On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes).","[""Parkinson's Disease"", 'We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits', ""individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits"", ""individuals with Parkinson's disease"", ""individuals with early, untreated Parkinson's disease""]",[],"['Feasibility, Reliability, and Value of Remote Video-Based Trial Visits', 'feasibility, reliability, and value of remote visits']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",40.0,0.0393541,"On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes).","[{'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Tarolli', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Andrzejewski', 'Affiliation': 'Department of Neurology, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bull', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Goldenthal', 'Affiliation': 'Center for Health+Technology, University of Rochester, Rochester, NY.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health+Technology, University of Rochester, Rochester, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'AMC Health, New York, NY, USA.'}, {'ForeName': 'E Ray', 'Initials': 'ER', 'LastName': 'Dorsey', 'Affiliation': 'Department of Neurology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Biglan', 'Affiliation': 'Early Phase Clinical Development, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Simuni', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202163']
2502,32211800,Macro- and Micronutrients in Milk from Healthy Cambodian Mothers: Status and Interrelations.,"BACKGROUND


Except for low thiamin content, little is known about vitamins or macronutrients in milk from Cambodian mothers, and associations among milk nutrients.
OBJECTIVES


We measured fat-soluble vitamins (FSVs) and water-soluble vitamins (WSVs), and macronutrients, and explored internutrient associations in milk from Cambodian mothers.
METHODS


Milk from women (aged 18-45 y, 3-27 wk postpartum, n = 68) who participated in a thiamin-fortification trial were analyzed for vitamins B-2 (riboflavin, FAD), B-3 (nicotinamide), B-5, B-6 (pyridoxal, pyridoxine), B-7, B-12, A, E [α-tocopherol and γ-tocopherol (γ-TPH)], carotenoids, carbohydrate (CHO), fat, and protein. Milk vitamin B-1 [thiamin, thiamin monophosphate (TMP), thiamin pyrophosphate (TPP)] was previously assessed for fortification effects. Milk nutrient concentrations were compared with the Adequate Intake (AI) values for infants aged 0-6 mo. Pearson correlation was used to examine internutrient associations after excluding nutrients affected by fortification.
RESULTS


Fortification increased thiamin and B-1 and decreased γ-TPH. Less than 40% of milk samples met the AIs for all vitamins, and 10 samples did not reach any AI values for the analyzed nutrients. CHO, fat, and energy values were met in 1.5-11.8%, and protein in 48.5%, of the samples. Whereas fat, protein, and energy were related (all r < 0.5; P < 0.001) and associated with FSVs and WSVs, CHO correlated only with some WSVs. TPP was not correlated with B-1 vitamers, but with other WSVs (r = 0.28-0.58; P < 0.019). All FSVs, except α-carotene, were correlated with each other (r = 0.42-0.98; P < 0.002). TPP, FAD, B-2, and B-3 were associated with almost all FSVs (r = 0.24-0.63; P < 0.044).
CONCLUSIONS


Cambodian women might not provide sufficient nutrients to their exclusively breastfeeding infants. Besides thiamin, all other vitamins measured were much lower than the AI. There were many strong correlations among macronutrients and vitamins; the extent to which these are explained by maternal diet, milk volume, maternal physiology, or genetics requires additional exploration.",2020,"Whereas fat, protein, and energy were related (all r < 0.5; P < 0.001) and associated with FSVs and WSVs, CHO correlated only with some WSVs.","['in Milk from Healthy Cambodian Mothers', 'milk from Cambodian mothers', 'Milk from women (aged 18-45 y, 3-27 wk postpartum, n\xa0=\xa068) who participated in a thiamin-fortification trial were analyzed for']","['Milk vitamin B-1 [thiamin, thiamin monophosphate (TMP), thiamin pyrophosphate (TPP', 'vitamins B-2 (riboflavin, FAD), B-3 (nicotinamide), B-5, B-6 (pyridoxal, pyridoxine', 'Macro- and Micronutrients']","['CHO, fat, and energy values', 'fat, protein, and energy', 'FSVs and WSVs, CHO', 'thiamin and B-1 and decreased γ-TPH', 'fat-soluble vitamins (FSVs) and water-soluble vitamins (WSVs), and macronutrients', 'TPP, FAD, B-2, and B-3', 'Milk nutrient concentrations', 'B-7, B-12, A, E [α-tocopherol and γ-tocopherol (γ-TPH)], carotenoids, carbohydrate (CHO), fat, and protein', 'TPP']","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0039848', 'cui_str': 'Thiamine pyrophosphate'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0015540', 'cui_str': 'Flavin-Adenine Dinucleotide'}, {'cui': 'C0378071', 'cui_str': '((5,6-dichloro-2,3,9,9a-tetrahydro-3-oxo-9a-propyl-1H-fluoren-7-yl)oxy)acetic acid'}, {'cui': 'C0034263', 'cui_str': 'Pyridoxal'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259753', 'cui_str': 'Fat soluble vitamin product'}, {'cui': 'C0259754', 'cui_str': 'Water-soluble vitamin'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0039848', 'cui_str': 'Thiamine pyrophosphate'}, {'cui': 'C0015540', 'cui_str': 'Flavin-Adenine Dinucleotide'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0378071', 'cui_str': '((5,6-dichloro-2,3,9,9a-tetrahydro-3-oxo-9a-propyl-1H-fluoren-7-yl)oxy)acetic acid'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",68.0,0.0364026,"Whereas fat, protein, and energy were related (all r < 0.5; P < 0.001) and associated with FSVs and WSVs, CHO correlated only with some WSVs.","[{'ForeName': 'Kyly C', 'Initials': 'KC', 'LastName': 'Whitfield', 'Affiliation': 'Department of Applied Human Nutrition, Mount Saint Vincent University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'USDA/ARS Western Human Nutrition Research Center, University of California, Davis, CA, USA.'}, {'ForeName': 'Hou', 'Initials': 'H', 'LastName': 'Kroeun', 'Affiliation': 'Helen Keller International Cambodia, Phnom Penh, Cambodia.'}, {'ForeName': 'Prak', 'Initials': 'P', 'LastName': 'Sophonneary', 'Affiliation': 'National Nutrition Programme, Maternal and Child Health Centre, Ministry of Health, Phnom Penh, Cambodia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'USDA/ARS Western Human Nutrition Research Center, University of California, Davis, CA, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hampel', 'Affiliation': 'USDA/ARS Western Human Nutrition Research Center, University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa070']
2503,33198876,[Study on mechanical ventilation pressure under continuous cuff pressure monitoring in critical patients].,"OBJECTIVE


To explore the effective pressure range under continuous cuff pressure monitoring in critical patients with mechanical ventilation, so as to achieve the goal of ensuring ventilation quality and reducing mucosal injury without increasing the incidence of endotracheal catheter displacement and aspiration.
METHODS


Ninety critically ill patients with non-pulmonary diseases admitted to the department of intensive care unit (ICU) of Airport Hospital of Tianjin Medical University from June 2017 to June 2019 were enrolled, and divided into three groups according to the random number table, with 30 patients in each group. For all patients in the three groups , the head of the bed was raised by 30 degree angleand the balloon was measured continuously. Cuff pressure in the three groups were maintained at 20, 25 and 30 cmH 2 O (1 cmH 2 O = 0.098 kPa) respectively. The patient's air leakage, oxygen saturation, tracheal tube displacement of each group were recorded every hour when the patients were calm. Fiberbronchoscope was used to aspirate sputum during extubation to check for mucosal damage. Chest X-ray examination was used to evaluate pulmonary infection and sputum bacteria culture examination was conducted at the same time.
RESULTS


There was no significant difference in gender, age and critical condition among the three groups. The number of patients with airway mucosal injury in the 30 cmH 2 O group was significantly higher than that in the 20 cmH 2 O group (cases: 8 vs. 4, P < 0.05). There was no significant difference in airway mucosal injury between Group 20 cmH 2 O and Group 25, Group 25 cmH 2 O and Group 30 cmH 2 O. When the balloon pressure was 20, 25, and 30 cmH 2 O, there was no significant difference in air bag leakage (cases: 14, 10, 12), trachea catheter displacement (cases: 18, 11, 16), ventilator-associated pneumonia (cases: 3, 4, 3), all P > 0.05, and there was no significant difference in mechanical ventilation time and the hospitalization time [mechanical ventilation time (hours): 77.07±65.34, 80.80±70.20, 77.60±65.23; the length of ICU stay (days): 5.70±3.74, 5.30±4.57, 6.23±3.51, all P > 0.05].
CONCLUSIONS


The cuff pressure of 20 cmH 2 O will not increase the mechanical ventilation time and hospitalization time of patients, while 20 cmH 2 O is much safer in airway mucosal injury.",2020,"There was no significant difference in airway mucosal injury between Group 20 cmH 2 O and Group 25, Group 25 cmH 2","['Ninety critically ill patients with non-pulmonary diseases admitted to the department of intensive care unit (ICU) of Airport Hospital of Tianjin Medical University from June 2017 to June 2019 were enrolled', 'critical patients with mechanical ventilation', 'critical patients']","['mechanical ventilation pressure under continuous cuff pressure monitoring', 'Fiberbronchoscope']","['mechanical ventilation time and the hospitalization time [mechanical ventilation time', 'Cuff pressure', 'trachea catheter displacement', 'mechanical ventilation time and hospitalization time', 'length of ICU stay', ""patient's air leakage, oxygen saturation, tracheal tube displacement"", 'airway mucosal injury', 'air bag leakage', 'ventilator-associated pneumonia', 'number of patients with airway mucosal injury']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0442629', 'cui_str': 'Airport'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040578', 'cui_str': 'Tracheal structure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333257', 'cui_str': 'Air leakage'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1260970', 'cui_str': 'Tracheal tube'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0162697', 'cui_str': 'Motor vehicle airbag'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",90.0,0.0226222,"There was no significant difference in airway mucosal injury between Group 20 cmH 2 O and Group 25, Group 25 cmH 2","[{'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of ICU, Airport Hospital of Tianjin Medical University, Tianjin 300308, China.'}, {'ForeName': 'Minghui', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of ICU, Airport Hospital of Tianjin Medical University, Tianjin 300308, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of ICU, General Hospital of Tianjin Medical University, Tianjin 300052, China. Corresponding author: Wei Li, Email: KGHLB2015@163.com.'}, {'ForeName': 'Shuanglin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of ICU, General Hospital of Tianjin Medical University, Tianjin 300052, China. Corresponding author: Wei Li, Email: KGHLB2015@163.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of ICU, General Hospital of Tianjin Medical University, Tianjin 300052, China. Corresponding author: Wei Li, Email: KGHLB2015@163.com.'}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200714-00523']
2504,33211508,Building empathy through motivation-based interventions.,"Empathy is associated with adaptive social and emotional outcomes; as such, a crucial outstanding question is whether it can be bolstered in ways that make practical differences in people's lives. Most empathy-building efforts address one's ability to empathize, increasing empathy by training skills like perspective taking. However, empathy is more than the ability to share and understand others' feelings; it also reflects underlying motives that drive people to experience or avoid it. As such, another strategy for increasing empathy could focus on shifting relevant motives. Here we explored this idea, leveraging two intervention techniques (mindsets and social norms) to increase motivation to empathize. Two hundred ninety-two first-year college students were randomly assigned to one of three intervention conditions-malleable mindset, social norms, or a combination of the two-or a control condition. Eight weeks later, participants in the intervention conditions endorsed stronger beliefs about empathy's malleability and exhibited greater empathic accuracy when rating others' positive emotions as compared to the control condition. They also reported having made a greater number of friends since starting college. The interventions did not affect outcomes related to intergroup processes or empathic accuracy when rating others' negative emotions, indicating a boundary condition for these interventions. This experiment underscores the potential of motivation-based empathy interventions to generate positive, real-world impact. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The interventions did not affect outcomes related to intergroup processes or empathic accuracy when rating others' negative emotions, indicating a boundary condition for these interventions.",['Two hundred ninety-two first-year college students'],"['intervention conditions-malleable mindset, social norms, or a combination of the two-or a control condition']",['empathic accuracy'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.0342782,"The interventions did not affect outcomes related to intergroup processes or empathic accuracy when rating others' negative emotions, indicating a boundary condition for these interventions.","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Desmond C', 'Initials': 'DC', 'LastName': 'Ong', 'Affiliation': 'Department of Information Systems and Analytics, National University of Singapore.'}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Carlson', 'Affiliation': 'Department of Psychology, Yale University.'}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Zaki', 'Affiliation': 'Department of Psychology, Stanford University.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000929']
2505,33211517,The effects of web-prolonged exposure among military personnel and veterans with posttraumatic stress disorder.,"OBJECTIVE


Web-based treatments address many of the logistical and stigma-related barriers to in-person behavioral health care. Prior studies of web-based treatments for posttraumatic stress disorder (PTSD) did not employ gold-standard treatments and have not compared to in-person therapy.
METHOD


We compared a web version of Prolonged Exposure Therapy, ""Web-PE,"" to in-person Present-Centered Therapy (PCT) in a randomized controlled trial (RCT) with 40 military personnel with PTSD seeking treatment at Fort Hood, Texas. Due to recruitment challenges, we terminated the RCT and subsequently examined the effects of Web-PE in an uncontrolled open trial with 34 service members and veterans recruited nationwide. Both studies assessed PTSD, depressive symptoms, and health functioning at baseline and 1 and 3 months posttreatment; the RCT also included a 6-month assessment.
RESULTS


Results of the RCT showed no differential impact for Web-PE and PCT, although more PCT participants achieved clinically significant change at one of the follow-up assessments. Both treatment conditions significantly reduced self-reported and blind independent interviewer-assessed symptoms of PTSD. Results of the open trial showed that Web-PE was associated with significant reductions in self-reported PTSD symptoms, with a much larger effect size than in the RCT.
CONCLUSIONS


Web-PE significantly reduced PTSD symptoms in both studies, although the reductions in PTSD symptoms were greater among open trial participants, who were specifically seeking a web-based treatment. Future research should evaluate Web-PE relative to another web-based treatment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results of the open trial showed that Web-PE was associated with significant reductions in self-reported PTSD symptoms, with a much larger effect size than in the RCT.
","['military personnel and veterans with posttraumatic stress disorder', '34 service members and veterans recruited nationwide', '40 military personnel with PTSD seeking treatment at Fort Hood, Texas']","['Prolonged Exposure Therapy, ""Web-PE,"" to in-person Present-Centered Therapy (PCT', 'RCT']","['self-reported PTSD symptoms', 'PTSD symptoms', 'PTSD, depressive symptoms, and health functioning']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0689,"Results of the open trial showed that Web-PE was associated with significant reductions in self-reported PTSD symptoms, with a much larger effect size than in the RCT.
","[{'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'Dissemination and Training Division.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Haddock', 'Affiliation': 'NDRI-USA.'}, {'ForeName': 'Madeleine L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'Dissemination and Training Division.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Department of Behavioral Health.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Hall-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000978']
2506,33211519,"An open-label, randomized controlled trial of the reconsolidation of traumatic memories protocol (RTM) in military women.","Objective:  PTSD in female veterans and service members (SMs) is understudied, and new, effective treatments for PTSD are needed. Reconsolidation of Traumatic Memories (RTM) is a brief, manualized treatment for PTSD previously piloted in RCTs of male veterans and SMs. Here we examine RTM's effect on military women with PTSD.  Method:  We report a waitlist RCT using 30 military-connected females with DSM-IV-TR PTSD diagnoses, including current-month nightmares or flashbacks. Trauma types include military sexual trauma, other sexual traumas, combat, and other trauma types. Participants were randomized to treatment or waitlist. Of those enrolled, 97% completed treatment. Independent psychometricians, blinded to treatment condition, evaluated participants at intake, postwait, and two weeks post. The clinician took follow-up measures at six months and one year. The primary measure was the PTSD Symptom Scale-Interview (PSS-I). The secondary measure was the PTSD Checklist. Participants received up to three 120-min sessions of RTM.  Results:  RTM eliminated intrusive symptoms and significantly decreased symptom scale ratings in 90% ( n  = 27) of participants, versus 0% of controls ( p  < .001). Two-week treatment group PSS-I scores dropped 33.9 points versus 3.9 points for postwait controls ( g  = 3.7; 95% CI [2.5, 4.8];  p  < .001). Treatment results were stable to 1 year.  Conclusions:  RTM effectively treated PTSD, independent of trauma source in female SMs and veterans effectively replicating previous results in male populations. Further research is recommended. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RTM eliminated intrusive symptoms and significantly decreased symptom scale ratings in 90% ( n  = 27) of participants, versus 0% of controls ( p  < .001).","['female veterans and service members (SMs', 'military women', 'military women with PTSD', '30 military-connected females with DSM-IV-TR PTSD diagnoses, including current-month nightmares or flashbacks']","['waitlist RCT', 'traumatic memories protocol (RTM']","['RTM eliminated intrusive symptoms', 'symptom scale ratings', 'PTSD Symptom Scale-Interview (PSS-I']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",,0.032736,"RTM eliminated intrusive symptoms and significantly decreased symptom scale ratings in 90% ( n  = 27) of participants, versus 0% of controls ( p  < .001).","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Gray', 'Affiliation': 'The Research and Recognition Project.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Budden-Potts', 'Affiliation': 'The Research and Recognition Project.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Schwall', 'Affiliation': 'The Research and Recognition Project.'}, {'ForeName': 'Frank F', 'Initials': 'FF', 'LastName': 'Bourke', 'Affiliation': 'The Research and Recognition Project.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000986']
2507,33211697,Personality profiles and meteoropathy intensity: A comparative study between young and older adults.,"OBJECTIVES


This study's main aims were to investigate the Big Five personality trait heterogeneity of study participants in two age groups and to examine whether these traits' heterogeneity can explain possible individual differences in meteoropathy intensity.
METHOD


The sample was comprised of 758 participants divided into two age groups: 378 young adults (18-30 years old) and 380 older adults (60+ years old). The participants filled out online or paper versions of the METEO-Q questionnaire and the Ten Item Personality Inventory (TIPI).
RESULTS


A latent profile analysis of the completed inventories showed various personality profiles differ in meteoropathy intensity. However, personality's differentiating effect on meteoropathy was observed only among the young adult group.
CONCLUSIONS


Our study's results indicate that there is no one personality trait pattern that fits all individuals regarding sensitivity to weather changes. This issue is especially visible when considering age differences.",2020,Our study's results indicate that there is no one personality trait pattern that fits all individuals regarding sensitivity to weather changes.,"['758 participants divided into two age groups: 378 young adults (18-30 years old) and 380 older adults (60+ years old', 'young and older adults']",[],"['Personality profiles and meteoropathy intensity', 'meteoropathy']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C1735327', 'cui_str': 'Meteoropathy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",758.0,0.0132419,Our study's results indicate that there is no one personality trait pattern that fits all individuals regarding sensitivity to weather changes.,"[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Rzeszutek', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Włodzimierz', 'Initials': 'W', 'LastName': 'Oniszczenko', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Zalewska', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Pięta', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}]",PloS one,['10.1371/journal.pone.0241817']
2508,33211710,Evaluating the integration of tuberculosis screening and contact investigation in tuberculosis clinics in Ethiopia: A mixed method study.,"BACKGROUND


Aligned with global childhood tuberculosis (TB) road map, Ethiopia developed its own in 2015. The key strategies outlined in the Ethiopian roadmap are incorporating TB screening in Integrated Maternal, Neonatal and Child Illnesses (IMNCI) clinic for children under five years (U5) and intensifying contact investigations at TB clinic. However, these strategies have never been evaluated.
OBJECTIVE


To evaluate the integration of tuberculosis (TB) screening and contact investigation into Integrated Maternal, Neonatal and Child Illnesses (IMNCI) and TB clinics in Addis Ababa, Ethiopia.
METHODS


The study used mixed methods with stepped-wedge design where 30 randomly selected health care facilities were randomized into three groups of 10 during August 2016-November 2017. The integration of TB screening into IMNCI clinic and contact investigation in TB clinic were introduced by a three-day childhood TB training for health providers. An in-depth interview was used to explore the challenges of the interventions and supplemented data on TB screening and contact investigation.
RESULTS


Overall, 180896 children attended 30 IMNCI clinics and145444 (80.4%) were screened for TB. A total of 688 (0.4%) children had presumptive TB and 47(0.03%) had TB. During the pre-intervention period, 51873 of the 85278 children (60.8%) were screened for TB as compared to 93570 of the 95618 children (97.9%) in the intervention (p<0.001). This had resulted in 149 (0.30%) and 539 (0.6%) presumptive TB cases in pre-intervention and intervention periods (p<0.001), respectively. Also, nine TB cases (6.0%) in pre-intervention and 38 (7.1%) after intervention were identified (p = 0.72). In TB clinics, 559 under-five (U5) contacts were identified and 419 (80.1%) were screened. In all, 51(9.1%) presumed TB cases and 12 (2.1%) active TB cases were identified from the traced contacts. TB screening was done for 182 of the 275 traced contacts (66.2%) before intervention and for 237 of the 284 of the traced (83.5%) under intervention (p<0.001). Isoniazid prevention therapy (IPT) was initiated for 69 of 163 eligible contacts (42.3%) before intervention and for 159 of 194 eligible children (82.0%) under intervention (p<0.001). Over 95% of health providers indicated that the integration of TB screening into IMNCI and contact investigation in TB clinic is acceptable and practical. Gastric aspiration to collect sputum using nasogastric tube was reported to be difficult.
CONCLUSIONS


Integrating TB screening into IMNCI clinics and intensifying contact investigation in TB clinics is feasible improving TB screening, presumed TB cases, TB cases, contact screening and IPT coverage during the intervention period. Stool specimen could be non-invasive to address the challenge of sputum collection.",2020,TB screening was done for 182 of the 275 traced contacts (66.2%) before intervention and for 237 of the 284 of the traced (83.5%) under intervention (p<0.001).,"['69 of 163 eligible contacts (42.3%) before intervention and for 159 of 194 eligible children (82.0%) under intervention (p<0.001', '30 randomly selected health care facilities were randomized into three groups of 10 during August 2016-November 2017', '180896 children attended 30 IMNCI clinics and145444 (80.4%) were screened for TB', 'tuberculosis clinics in Ethiopia', 'A total of 688 (0.4%) children had presumptive TB and 47(0.03%) had TB']",['Isoniazid prevention therapy (IPT'],['TB screening'],"[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517457', 'cui_str': '0.4'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",180896.0,0.0552935,TB screening was done for 182 of the 275 traced contacts (66.2%) before intervention and for 237 of the 284 of the traced (83.5%) under intervention (p<0.001).,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ketema', 'Affiliation': 'KNVC Tuberculosis Foundation/Management Sciences for Health USAID/Challenge TB Project, Addis Ababa, Ethiopia.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Dememew', 'Affiliation': 'KNVC Tuberculosis Foundation/Management Sciences for Health USAID/Challenge TB Project, Addis Ababa, Ethiopia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Assefa', 'Affiliation': 'KNVC Tuberculosis Foundation/Management Sciences for Health USAID/Challenge TB Project, Addis Ababa, Ethiopia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gudina', 'Affiliation': 'Federal Ministry of Health of Ethiopia, National TB Program and Child Health Unit, Addis Ababa, Ethiopia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kassa', 'Affiliation': 'Federal Ministry of Health of Ethiopia, National TB Program and Child Health Unit, Addis Ababa, Ethiopia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Letta', 'Affiliation': 'Federal Ministry of Health of Ethiopia, National TB Program and Child Health Unit, Addis Ababa, Ethiopia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ayele', 'Affiliation': 'Federal Ministry of Health of Ethiopia, National TB Program and Child Health Unit, Addis Ababa, Ethiopia.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tadesse', 'Affiliation': 'Federal Ministry of Health of Ethiopia, National TB Program and Child Health Unit, Addis Ababa, Ethiopia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tegegn', 'Affiliation': 'Addis Ababa City Administration Health Bureau, Addis Ababa, Ethiopia.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Datiko', 'Affiliation': 'KNVC Tuberculosis Foundation/Management Sciences for Health USAID/Challenge TB Project, Addis Ababa, Ethiopia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Negeri', 'Affiliation': 'KNVC Tuberculosis Foundation/Management Sciences for Health USAID/Challenge TB Project, Addis Ababa, Ethiopia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bedru', 'Affiliation': 'KNVC Tuberculosis Foundation/Management Sciences for Health USAID/Challenge TB Project, Addis Ababa, Ethiopia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Klinkenberg', 'Affiliation': 'KNCV Tuberculosis Foundation, The Hague, Netherlands.'}]",PloS one,['10.1371/journal.pone.0241977']
2509,33211728,Learning curve and performance in simulated difficult airway for the novel C-MAC® video-stylet and C-MAC® Macintosh video laryngoscope: A prospective randomized manikin trial.,"Difficult airways can be managed with a range of devices, with video laryngoscopes (VLs) being the most common. The C-MAC® Video-Stylet (VS; Karl-Storz Germany), a hybrid between a flexible and a rigid intubation endoscope, has been recently introduced. The aim of this study is to investigate the performance of the VS compared to a VL (C-MAC Macintosh blade, Karl-Storz Germany) with regards to the learning curve for each device and its ability to manage a simulated difficult airway manikin. This is a single-center, prospective, randomized, crossover study involving twenty-one anesthesia residents performing intubations on a Bill 1™ (VBM, Germany) airway manikin model. After a standardized introduction, six randomized attempts with VL and VS were performed on the manikin. This was followed by intubation in a simulated difficult airway (cervical collar and inflated tongue) with both devices in a randomized fashion. The primary end-point of this study was the total time to intubation. All continuous variables were expressed as the median [interquartile range] and analyzed using the Mann-Whitney U test. A 2-way ANOVA with Bonferroni's post hoc test was used to compare both devices at each trial. All reported p values are two sided. The median total time to intubation on a simulated difficult airway was faster with the VS compared to VL (17 [13.5-25] sec vs 23 [18.5-26.5] sec, respectively; 95% CI; P = 0.031). Additionally, on a normal airway manikin, the VS has a comparable learning curve to the VL. In this manikin-based study, the novel VS was comparable to the VL in terms of learning curve in a normal airway. In a simulated difficult airway, the total time to intubation, though likely not clinically relevant, was faster with the VS to the VL. However, given the above findings, this study justifies further human clinical trials with the VS to see if similar benefits-faster time to intubation and similar learning curve to VL-are replicated clinically.",2020,"The median total time to intubation on a simulated difficult airway was faster with the VS compared to VL (17 [13.5-25] sec vs 23 [18.5-26.5] sec, respectively; 95% CI; P = 0.031).","['twenty-one anesthesia residents performing intubations on a Bill 1™ (VBM, Germany) airway manikin model']","['VL (C-MAC Macintosh blade, Karl-Storz Germany', 'MAC® video-stylet and C-MAC® Macintosh video laryngoscope']","['median total time to intubation', 'total time to intubation']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0004895', 'cui_str': 'Beak'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",21.0,0.0405739,"The median total time to intubation on a simulated difficult airway was faster with the VS compared to VL (17 [13.5-25] sec vs 23 [18.5-26.5] sec, respectively; 95% CI; P = 0.031).","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Pius', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, University of Western Ontario, LHSC- University Hospital, London, Ontario, Canada.'}, {'ForeName': 'Ruediger R', 'Initials': 'RR', 'LastName': 'Noppens', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, University of Western Ontario, LHSC- University Hospital, London, Ontario, Canada.'}]",PloS one,['10.1371/journal.pone.0242154']
2510,33211799,"Obinutuzumab versus Rituximab in young patients with advanced DLBCL, a PET-guided and randomized phase 3 study by LYSA.","Rituximab plus polychemotherapy is standard of care in diffuse large B-cell lymphoma (DLBCL). GAINED trial compares obinutuzumab to rituximab. GAINED (NCT01659099) is an open-label, randomized phase 3 trial. Transplant-eligible patients (18-60yrs) with untreated aged-adjusted international prognostic index (aaIPI) ≥1 DLBCL were randomized (1:1) between obinutuzumab or rituximab. Patients were stratified by aaIPI (1; 2-3) and chemotherapy regimen (ACVBP; CHOP). Consolidation treatment was determined according to response assessed by centrally reviewed interim semi-quantitative PET. Responders after cycle 2 and 4 (PET2-/PET4-) received planned immuno-chemotherapy consolidation. Responders only after cycle 4 (PET2+/4-) received high-dose methotrexate plus transplantation. The primary objective was an 8% improvement (HR=0.73; 80% power; alpha risk 2.5%; one-sided) in 2-year event-free survival (EFS) in the obinutuzumab arm. Events included death, progression, PET 2 or 4 positivity, modification of planned treatment. From September 20, 2012, 670 patients were enrolled (obinutuzumab n=336; rituximab n=334). 383 (57.2%) were aaIPI 2-3, 339 (50.6%) received CHOP and 324 (48.4%) received ACVBP. Median follow-up was 38.7 months. The 2-year EFS were similar in obinutuzumab and rituximab groups (59.8% vs 56.6%; p=0.123; HR=0.88). The 2-year PFS in the whole cohort was 83.1% (95%CI 80-85.8). PET2-/4- and PET2+/4- had similar 2-year PFS and OS (89.9% vs 83.9%) and 94.8% vs 92.8%). The 2-year PFS and OS for PET4+ patients were 62% and 83.1%. Grade 3-5 infections were more frequent in the obinutuzumab arm (21% vs 12%). Obinutuzumab is not superior to rituximab in untreated aaIPI≥1 DLBCL transplant-eligible patients.",2020,The 2-year PFS in the whole cohort was 83.1% (95%CI 80-85.8).,"['untreated aaIPI≥1 DLBCL transplant-eligible patients', 'Transplant-eligible patients (18-60yrs) with untreated aged-adjusted international prognostic index (aaIPI) ≥1', 'young patients with advanced DLBCL', 'From September 20, 2012, 670 patients were enrolled (obinutuzumab n=336; rituximab n=334']","['obinutuzumab or rituximab', 'Obinutuzumab versus Rituximab', 'Obinutuzumab', 'chemotherapy regimen (ACVBP; CHOP', 'CHOP', 'planned immuno-chemotherapy consolidation', 'ACVBP', 'Rituximab plus polychemotherapy', 'methotrexate plus transplantation', 'rituximab']","['2-year event-free survival (EFS', 'Grade 3-5 infections', 'death, progression, PET 2 or 4 positivity, modification of planned treatment', '2-year PFS and OS', '2-year EFS', '2-year PFS']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0278348', 'cui_str': 'Immunotherapy for cancer'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",670.0,0.128379,The 2-year PFS in the whole cohort was 83.1% (95%CI 80-85.8).,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'CHU nantes, Nantes, France.'}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Ghesquieres', 'Affiliation': 'Centre Hospitalier Lyon Sud, Pierre-Benite, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Obéric', 'Affiliation': 'Department of Hematology, Institut universitaire du cancer Toulouse- Oncopole, Toulouse, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morschhauser', 'Affiliation': 'CHU Lille, ULR 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.'}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Institut Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lamy', 'Affiliation': 'Rennes University Hospital, INSERM Research Unit 1236, Rennes, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Hôpital Saint-Louis, Service Hématologie Oncologie, Université de Paris, Paris, France ;, Paris, France.'}, {'ForeName': 'Herve Gerard', 'Initials': 'HG', 'LastName': 'Maisonneuve', 'Affiliation': 'chd les oudairies, La Roche sur Yon, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Gressin', 'Affiliation': 'chu michallon, GRENOBLE, France.'}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': ""Service d'Hématologie clinique et Thérapie cellulaire, PESSAC, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Haioun', 'Affiliation': 'CHU Henri Mondor, Créteil, France.'}, {'ForeName': 'Gandhi', 'Initials': 'G', 'LastName': 'Damaj', 'Affiliation': 'Normandy University, Hematology Institute, Caen, France.'}, {'ForeName': 'Luc-Matthieu', 'Initials': 'LM', 'LastName': 'Fornecker', 'Affiliation': 'Hôpitaux Universitaires de Strasbourg, STRASBOURG, France.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Centre Hospitalier Universitaire Nancy and INSERM 1256, Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sibon', 'Affiliation': 'Hôpital Universitaire Necker - Enfants Malades, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'CHU Montpellier UMR5535, Montpellier, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bonnet', 'Affiliation': 'CHU LIEGE, Liège, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'André', 'Affiliation': 'CHU UCL Namur, Yvoir, Belgium.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Chartier', 'Affiliation': 'LYSARC, PIERRE-BENITE, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ruminy', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kraeber-Bodere', 'Affiliation': 'CHU Nantes, Nantes Cedex 3, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bodet-Milin', 'Affiliation': 'CHU Nantes.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Berriolo-Riedinger', 'Affiliation': 'Centre G. F. LECLERC, Dijon, France.'}, {'ForeName': 'Josette', 'Initials': 'J', 'LastName': 'Briere', 'Affiliation': ""Institut universitaire d'hématologie Neckergie, St Louis, PARIS, France.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Jais', 'Affiliation': 'Université Paris-Descartes, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Molina', 'Affiliation': 'Necker-Enfants Malades University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Itti', 'Affiliation': 'CHU Henri Mondor, Creteil, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'C.H.U Dijon Bourgogne, Dijon, France.'}]",Blood,['10.1182/blood.2020008750']
2511,33211860,Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.,"BACKGROUND


It is imperative to identify new targets for improved vaccines and therapeutics against influenza and one such target is the relatively conserved stalk region of the influenza A hemagglutinin (HA) surface protein.
METHODS


We conducted a randomized, double-blind, Phase II placebo-controlled trial of a monoclonal antibody that targets the HA stalk (CR6261) in a H1N1pdm09 healthy volunteer human challenge model. A single 50mg/kg dose of CR6261 was infused 24 hours after challenge and the primary efficacy outcome was area under the curve of viral RNA detection over time.
RESULTS


Ninety-one healthy volunteers were randomized and underwent influenza challenge; 49 received CR6261 and 42 placebo. CR6261 had no statistically significant effect on AUC (AUC 48.56 log (copies/mL) x days, IQR 202 vs. AUC 25.53 log (copies/mL) x days, IQR 155), P=0.315), and no clinically significant effect on influenza disease measures including number of symptoms, duration of symptoms, or FLU-PRO scores. Preexisting anti-NA antibody titers were most predictive of reduced influenza disease. CR6261 reached a mean peak serum concentration of 1x10 6 ng/ml 15 minutes after infusion, and a mean peak of 5.97x10 2 ng/ml in the nasal mucosa 2-3 days after infusion.
CONCLUSIONS


The results of this study suggest that a monoclonal anti-stalk approach to prevent or treat influenza infection may be limited in efficacy. Future approaches should consider including and evaluating anti-stalk antibodies as part of a multi-faceted strategy rather than as a standalone therapeutic.",2020,CR6261 had no statistically significant effect on AUC (AUC 48.56 log (copies/mL),"['H1N1 Healthy Human Challenge Model', 'H1N1pdm09 healthy volunteer human challenge model', 'Ninety-one healthy volunteers']","['HA stalk (CR6261', 'CR6261 and 42 placebo', 'placebo', 'CR6261']","['mean peak serum concentration', 'influenza disease measures including number of symptoms, duration of symptoms, or FLU-PRO scores', 'AUC (AUC 48.56 log (copies/mL', 'area under the curve of viral RNA detection over time', 'Safety and Efficacy']","[{'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0935572', 'cui_str': 'Stalking'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",91.0,0.228102,CR6261 had no statistically significant effect on AUC (AUC 48.56 log (copies/mL),"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Czajkowski', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Luz Angela', 'Initials': 'LA', 'LastName': 'Rosas', 'Affiliation': 'Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cervantes-Medina', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gouzoulis', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Lumbard', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Research Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Reed', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Athota', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Holly Ann', 'Initials': 'HA', 'LastName': 'Baus', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lwin', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, Netherlands.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'Janssen Infectious Diseases and Vaccines, Leiden, Netherlands.'}, {'ForeName': 'Jeffery K', 'Initials': 'JK', 'LastName': 'Taubenberger', 'Affiliation': 'Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Memoli', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1725']
2512,33214537,Exploratory Analysis of Racial/Ethnic and Educational Differences in a Randomized Controlled Trial of a Mindfulness-based Weight Loss Intervention.,"OBJECTIVE


People of color and lower socioeconomic groups have higher obesity prevalence, lose less weight compared with Whites and higher socioeconomic groups, and are underrepresented in randomized controlled trials of mindfulness-based interventions. We examined whether mindfulness approaches reduce disparities in weight loss interventions.
METHODS


We analyzed data from a randomized controlled trial of 194 participants with obesity (41% participants of color, 36% without college degree) comparing a 5.5-month mindfulness-based weight loss intervention to an active-control with identical diet-exercise guidelines. We assessed attendance, 18-month attrition, and weight change at 6, 12, and 18 months by race/ethnicity and education level using linear mixed models, adjusting for baseline body mass index, age, and education or race/ethnicity, respectively.
RESULTS


Participants without versus with a college degree attended fewer sessions and had higher attrition across interventions. Participants of color attended fewer intervention sessions in the mindfulness compared with the control intervention. Overall, participants of color lost significantly less weight at 12 and 18 months compared with Whites. However, during the 6- to 18-month maintenance period, we found an interaction of intervention arm, race/ethnicity, and time (p = .035), indicating that participants of color compared with Whites regained more weight in the control (0.33 kg/mo; p = .005) but not mindfulness intervention (0.06 kg/mo; p = .62). Participants without a college degree had greater initial weight loss in the mindfulness compared to control intervention from 0 to 6 months (-0.46 kg/mo; p = .039).
CONCLUSIONS


Although disparities persist, mindfulness approaches may mitigate some racial/ethnic and socioeconomic differences in weight loss compared with conventional diet-exercise programs.
TRIAL REGISTRATION


Clinicaltrials.gov registration: NCT00960414.",2020,"Participants without a college degree had greater initial weight loss in the mindfulness compared to control intervention from 0 to 6 months (-0.46 kg/mo; p = .039).
","['194 participants with obesity (41% participants of color, 36% without college degree']","['5.5-month mindfulness-based weight loss intervention to an active-control with identical diet-exercise guidelines', 'Mindfulness-based Weight Loss Intervention']","['weight loss', 'initial weight loss', 'weight', 'attendance, 18-month attrition, and weight change']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",194.0,0.0884933,"Participants without a college degree had greater initial weight loss in the mindfulness compared to control intervention from 0 to 6 months (-0.46 kg/mo; p = .039).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': 'From the Institute of Holistic Health Studies (Daubenmier), San Francisco State University; Osher Center for Integrative Medicine (Chao, Hartogensis, Liu, Moran, Acree, Hecht), University of California, San Francisco, San Francisco, California; Department of Psychology (Kristeller), Indiana State University, Terre Haute, Indiana; and Department of Psychiatry (Epel), University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Chao', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hartogensis', 'Affiliation': ''}, {'ForeName': 'Rhianon', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Acree', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kristeller', 'Affiliation': ''}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': ''}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000859']
2513,33214579,A new fat-dissociation method to detect lymph nodes in colorectal cancer: a prospective randomized study.,"Histological examination of the lymph nodes (LNs) is crucial to determine the colorectal cancer (CRC) stage. We previously reported a new fat-dissociation method (FM) to detect LNs from surgically resected mesentery. This study aimed to examine the effectiveness of FM compared with that of conventional palpation method (PM) in CRC. This single-center, open-label, randomized controlled study was performed at Osaka International Cancer Institute in Japan in 2014. Randomization was performed using a computer-generated permuted-block sequence. Patients were stratified by surgical procedures and the LN dissection area. The primary endpoint was the time required for LN identification. The secondary endpoint was the number of LNs and 5-year cancer-specific survival. The 130 enrolled patients were randomly assigned in a 1:1 ratio to the FM and the PM groups. LN identification times were 45 (range 15-80) and 15 (range 7-30) minutes in the PM and the FM groups, respectively (P < 0.001). In the PM group, body mass index and identification time were correlated (P = 0.047). The number of LN which could be examined pathologically was 16 (range 2-48) and 18 (range 4-95) in the PM and FM groups, respectively (P = 0.546). In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031). Relapse-free survival rates and cancer-specific survival rates did not differ between the groups. In conclusion, FM reduced the time required for LN detection without reducing the number of detected LNs, making it is a useful method to detect LNs in surgical specimens.",2020,"In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031).","['colorectal cancer', 'Osaka International Cancer Institute in Japan in 2014', '130 enrolled patients']","['FM', 'conventional palpation method (PM']","['number of LNs and 5-year cancer-specific survival', 'LN identification times', 'Relapse-free survival rates and cancer-specific survival rates', 'number of LNs', 'body mass index and identification time', 'time required for LN identification']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",130.0,0.0656358,"In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031).","[{'ForeName': 'Shiki', 'Initials': 'S', 'LastName': 'Fujino', 'Affiliation': 'Innovative Oncology Research and Translational Medicine, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Norikatsu', 'Initials': 'N', 'LastName': 'Miyoshi', 'Affiliation': 'Innovative Oncology Research and Translational Medicine, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan. nmiyoshi@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Ito', 'Affiliation': 'Innovative Oncology Research and Translational Medicine, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Yasui', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Matsuda', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Nariaki', 'Initials': 'N', 'LastName': 'Matsuura', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}]",Scientific reports,['10.1038/s41598-020-77195-8']
2514,33214586,No effect of moderate alcohol intake on the detection of concealed identity information in the laboratory.,"The Concealed Information Test (CIT) enables the detection of certain (e.g., crime-relevant or personal) information, even if participants aim to conceal their knowledge. The current preregistered study investigated whether previously observed impairing effects of alcohol intoxication on participants' performance in a reaction time CIT (RT CIT) field study also translate to a laboratory environment. In contrast to the previous study of Suchotzki and Gamer (Sci Rep 8:7825, 2018) in which alcohol consumption was voluntary and self-administered, the current study used a randomized assignment of participants to either an alcohol group (n = 88; receiving a drink with 3 cl alcohol) or a sober control group (n = 89; receiving a drink with just some alcohol drops to hide group assignment). After drink administration, participants completed an RT CIT, in which they were instructed to hide knowledge of their own identity. Blood alcohol concentration (BAC) was estimated via breath alcohol ratio. In contrast to the previous field study, results revealed no differences in CIT-performance between intoxicated and sober participants. Aside from questioning the robustness of the result of the previous field study, our results also point to a number of interesting theoretical explanations for the discrepancy between both results, which are elaborated in the discussion.",2020,"In contrast to the previous field study, results revealed no differences in CIT-performance between intoxicated and sober participants.",[],"['alcohol group (n\u2009=\u200988; receiving a drink with 3\xa0cl alcohol) or a sober control group (n\u2009=\u200989; receiving a drink with just some alcohol drops to hide group assignment', 'alcohol intoxication']","['CIT-performance', 'Blood alcohol concentration (BAC']",[],"[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]","[{'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}]",,0.0239192,"In contrast to the previous field study, results revealed no differences in CIT-performance between intoxicated and sober participants.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Suchotzki', 'Affiliation': 'Social and Legal Psychology, Institute of Psychology, University of Mainz, Binger Str. 14-16, 55122, Mainz, Germany. kristina.suchotzki@uni-mainz.de.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'May', 'Affiliation': 'Department of Psychology, University of Würzburg, Marcusstr. 9-11, 97070, Würzburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gamer', 'Affiliation': 'Department of Psychology, University of Würzburg, Marcusstr. 9-11, 97070, Würzburg, Germany.'}]",Scientific reports,['10.1038/s41598-020-76811-x']
2515,33214593,Efficacy of P 11 -4 for the treatment of initial buccal caries: a randomized clinical trial.,"To investigate the safety and efficacy of Self-Assembling Peptide P 11 -4 (SAP P 11 -4) compared to placebo or fluoride varnish (FV), a randomized, controlled, blinded, split-mouth study with sequential design was conducted. Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were randomly assigned to test or control. Control received placebo at baseline (D0) and test SAP P 11 -4, all received FV at Day 90 (D90). Standardized photographs were taken at each visit, and WSL size changes were morphometrically assessed. Hierarchical Linear Modelling, considering paired and sequential design, was used to test four hypotheses. SAP P 11 -4 lesions (test, D90-D0) showed significant WSL size reduction compared to placebo (control, D90-D0; p = 0.008) or FV (control, D180-D90; p = 0.001). Combination of SAP P 11 -4 and delayed FV after 90 days (test, D180-D0), showed a significant difference compared to FV alone (control D270-D90; p = 0.003). No significant difference on FV efficacy was found when SAP P 11 -4 was applied 3 months before FV (test D270-D90; control D270-D90, p = 0.70). SAP P 11 -4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P 11 -4. SAP P 11 -4 was found to be a safe and effective WSL treatment.",2020,"SAP P 11 -4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P 11 -4.","['initial buccal caries', 'Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth']","['Self-Assembling Peptide P 11 -4 (SAP P 11 -4', 'placebo or fluoride varnish (FV', 'placebo']","['FV efficacy', 'WSL size reduction', 'SAP P 11 -4 and delayed FV']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0647980', 'cui_str': 'peptide P (properdin)'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0069877', 'cui_str': 'P 11'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0069877', 'cui_str': 'P 11'}]",2.0,0.0849517,"SAP P 11 -4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P 11 -4.","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Sedlakova Kondelova', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Mannaa', 'Affiliation': 'Division of Operative Dentistry, Department of Restorative Dentistry, Faculty of Dentistry, King Abdulaziz University, P.O. Box 80209, Jeddah, 21589, Kingdom of Saudi Arabia.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Bommer', 'Affiliation': 'Credentis AG, Dorfstrasse 69, 5210, Windisch, Switzerland.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdelaziz', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Daeniker', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'di Bella', 'Affiliation': 'Department of Political Sciences, University of Genova, P.le E. Brignole 3a, 16126, Genova, Italy.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krejci', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland. Ivo.Krejci@unige.ch.'}]",Scientific reports,['10.1038/s41598-020-77057-3']
2516,33215099,The rate of patient deferral and barriers to going forward with elective orthopaedic surgery during the COVID-19 pandemic.,"Aims


The primary aim was to assess the rate of patient deferral of elective orthopaedic surgery and whether this changed with time during the coronavirus disease 2019 (COVID-19) pandemic. The secondary aim was to explore the reasons why patients wanted to defer surgery and what measures/circumstances would enable them to go forward with surgery.
Methods


Patients were randomly selected from elective orthopaedic waiting lists at three centres in the UK in April, June, August, and September 2020 and were contacted by telephone. Patients were asked whether they wanted to proceed or defer surgery. Patients who wished to defer were asked seven questions relating to potential barriers to proceeding with surgery and were asked whether there were measures/circumstances that would allow them to go forward with surgery.
Results


There was a significant decline in the rate of deferral for surgery from April (n = 38/50, 76%), June (n = 68/233, 29%), to August (n = 6/50, 12%) and September (n = 5/100, 5%) (p < 0.001). Patients wishing to defer were older (68 years (SD 10.1) vs 65 (SD 11.9)), more likely to be female (65% (44/68) vs 53% (88/165)) and waiting for a knee arthroplasty (65% (44/68) vs 41% (67/165); p < 0.001). By September 2020, all patients that deferred in June at one centre had proceeded or wanted to proceed with surgery due to a perceived lower risk of acquiring COVID-19 perioperatively (68%, n = 15) or because their symptoms had progressed (32%, n = 7). The most common reason (n = 14/17, 82%) for patients deferring surgery in September was the perceived risk of acquiring COVID-19 while as an inpatient. When asked what measures or circumstances would enable them to proceed with surgery, the most common (n = 7, 41%) response was reassurance of a COVID-19 free hospital.
Conclusion


The rate of deferral fell to 5% by September, which was due to a lower perceived risk of contracting COVID-19 perioperatively or worsening of symptoms while waiting. The potential of a COVID-19-free hospital and communication of mortality risk may improve a patient's willingness to go forward with surgery.Cite this article:  Bone Joint Open  2020;1-10:663-668.",2020,"There was a significant decline in the rate of deferral for surgery from April (n = 38/50, 76%), June (n = 68/233, 29%), to August (n = 6/50, 12%) and September (n = 5/100, 5%) (p < 0.001).","['Methods\n\n\nPatients were randomly selected from elective orthopaedic waiting lists at three centres in the UK in April, June, August, and September 2020 and were contacted by telephone', 'Patients who wished to defer were asked seven questions relating to potential barriers to proceeding with surgery', 'By September 2020, all patients that deferred in June at one centre had proceeded or wanted to proceed with surgery due to a perceived lower risk of acquiring COVID-19 perioperatively (68%, n = 15) or because their symptoms had progressed (32%, n = 7']",['elective orthopaedic surgery'],"['rate of deferral fell', 'rate of patient deferral and barriers to going forward with elective orthopaedic surgery', 'waiting for a knee arthroplasty', 'rate of deferral for surgery']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",,0.0956658,"There was a significant decline in the rate of deferral for surgery from April (n = 38/50, 76%), June (n = 68/233, 29%), to August (n = 6/50, 12%) and September (n = 5/100, 5%) (p < 0.001).","[{'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Department of Orthopaedics, Freeman Hospital, Newcastle, United Kingdom.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Oussedik', 'Affiliation': 'Department of Orthopaedics, University College Hospital, London, United Kingdom.'}, {'ForeName': 'Kamran I', 'Initials': 'KI', 'LastName': 'Raza', 'Affiliation': 'Department of Orthopaedics, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Robyn F L', 'Initials': 'RFL', 'LastName': 'Patton', 'Affiliation': 'Medical School; Biomedical Sciences, Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedics, Freeman Hospital, Newcastle, United Kingdom.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Deehan', 'Affiliation': 'Department of Orthopaedics, Freeman Hospital, Newcastle, United Kingdom.'}]",Bone & joint open,['10.1302/2633-1462.110.BJO-2020-0135.R1']
2517,33215101,Robotic-assisted total knee arthroplasty demonstrates decreased postoperative pain and opioid usage compared to conventional total knee arthroplasty.,"Aims


Robotic-assisted total knee arthroplasty (RA-TKA) has been introduced to provide accurate bone cuts and help achieve the target knee alignment, along with symmetric gap balancing. The purpose of this study was to determine if any early clinical benefits could be realized following TKA using robotic-assisted technology.
Methods


In all, 140 consecutive patients undergoing RA-TKA and 127 consecutive patients undergoing conventional TKA with minimum six-week follow-up were reviewed. Differences in visual analogue scores (VAS) for pain at rest and with activity, postoperative opiate usage, and length of stay (LOS) between the RA-TKA and conventional TKA groups were compared.
Results


Patients undergoing RA-TKA had lower average VAS pain scores at rest (p = 0.001) and with activity (p = 0.03) at two weeks following the index procedure. At the six-week interval, the RA-TKA group had lower VAS pain scores with rest (p = 0.03) and with activity (p = 0.02), and required 3.2 mg less morphine equivalents per day relative to the conventional group (p < 0.001). At six weeks, a significantly greater number of patients in the RA-TKA group were free of opioid use compared to the conventional TKA group; 70.7% vs 57.0% (p = 0.02). Patients in the RA-TKA group had a shorter LOS; 1.9 days versus 2.3 days (p < 0.001), and also had a greater percentage of patient discharged on postoperative day one; 41.3% vs 20.5% (p < 0.001).
Conclusion


Patients undergoing RA-TKA had lower pain levels at both rest and with activity, required less opioid medication, and had a shorter LOS.",2020,"Results


Patients undergoing RA-TKA had lower average VAS pain scores at rest (p = 0.001) and with activity (p = 0.03) at two weeks following the index procedure.",['140 consecutive patients undergoing RA-TKA and 127 consecutive patients undergoing conventional TKA with minimum six-week follow-up were reviewed'],"['Robotic-assisted total knee arthroplasty', 'TKA', 'Robotic-assisted total knee arthroplasty (RA-TKA', 'conventional total knee arthroplasty']","['postoperative pain and opioid usage', 'VAS pain scores', 'visual analogue scores (VAS) for pain at rest and with activity, postoperative opiate usage, and length of stay (LOS', 'lower pain levels', 'average VAS pain scores', 'shorter LOS']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",140.0,0.119836,"Results


Patients undergoing RA-TKA had lower average VAS pain scores at rest (p = 0.001) and with activity (p = 0.03) at two weeks following the index procedure.","[{'ForeName': 'Samrath J', 'Initials': 'SJ', 'LastName': 'Bhimani', 'Affiliation': 'Department of Orthopaedic Surgery, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Rohat', 'Initials': 'R', 'LastName': 'Bhimani', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedic Surgery, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Eccles', 'Affiliation': 'Department of Orthopaedic Surgery, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Langan', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'U of L Health, UL Physicians - Orthopedic Group, Louisville, Kentucky, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Malkani', 'Affiliation': 'University of Louisville, Department of Orthopaedic Surgery, Louisville, Kentucky, USA.'}]",Bone & joint open,['10.1302/2633-1462.12.BJO-2019-0004.R1']
2518,33215102,Economic evaluation plan of a RCT of hydroxyapatite-coated uncemented hemiarthroplasty versus cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures: the WHiTE5 trial.,"Aim


This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial.
Methods


A within-trial cost-utility analysis (CUA) will be conducted at four months postinjury from a health system (National Health Service and personal social services) perspective. Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months. Sensitivity analysis will be conducted to assess the robustness of the results.
Conclusion


The planned analysis strategy described here records our intent to conduct a within-trial CUA alongside the WHiTE5 trial.",2020,"Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months.","['hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial', 'displaced intracapsular hip fractures']","['hydroxyapatite-coated uncemented hemiarthroplasty versus cemented hemiarthroplasty', 'cemented versus uncemented hemiarthroplasty']",['cost-effectiveness'],"[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.118657,"Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months.","[{'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK; Trauma & Orthopaedic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'McGibbon', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}]",Bone & joint open,['10.1302/2633-1462.13.BJO-2020-0003']
2519,33215140,The STAK tool: evaluation of a new device to treat arthrofibrosis and poor range of movement following total knee arthroplasty and major knee surgery.,"Aims


This study aims to evaluate a new home medical stretching device called the Self Treatment Assisted Knee (STAK) tool to treat knee arthrofibrosis.
Methods


35 patients post-major knee surgery with arthrofibrosis and mean range of movement (ROM) of 68° were recruited. Both the STAK intervention and control group received standard physiotherapy for eight weeks, with the intervention group additionally using the STAK at home. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Scores (OKS) were collected at all timepoints. An acceptability and home exercise questionnaire capturing adherence was recorded after each of the interventions.
Results


Compared to the control group, the STAK intervention group made significant gains in mean ROM (30° versus 8°, p < 0.0005), WOMAC (19 points versus 3, p < 0.0005), and OKS (8 points versus 3, p < 0.0005). The improvements in the STAK group were maintained at long-term follow-up. No patients suffered any complications relating to the STAK, and 96% of patients found the STAK tool 'perfectly acceptable'.
Conclusion


The STAK tool is effective in increasing ROM and reducing pain and stiffness. Patients find it acceptable and adherence to treatment was high. This study indicates that the STAK tool would be of benefit in clinical practice and may offer a new, cost-effective treatment for arthrofibrosis.Cite this article:  Bone Joint Open  2020;1-8:465-473.",2020,"Compared to the control group, the STAK intervention group made significant gains in mean ROM (30° versus 8°, p < 0.0005), WOMAC (19 points versus 3, p < 0.0005), and OKS (8 points versus 3, p < 0.0005).","['35 patients post-major knee surgery with arthrofibrosis and mean range of movement (ROM) of 68° were recruited', 'total knee arthroplasty and major knee surgery']","['Self Treatment Assisted Knee (STAK', 'STAK intervention', 'standard physiotherapy']","['OKS', 'mean ROM', 'WOMAC', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Scores (OKS', 'acceptability and home exercise questionnaire capturing adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C1142253', 'cui_str': 'Arthrofibrosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0264736,"Compared to the control group, the STAK intervention group made significant gains in mean ROM (30° versus 8°, p < 0.0005), WOMAC (19 points versus 3, p < 0.0005), and OKS (8 points versus 3, p < 0.0005).","[{'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Aspinall', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Sport and Exercise Medicine, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Godsiff', 'Affiliation': 'Department of Orthopaedic Surgery, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Hignett', 'Affiliation': 'Loughborough Design School, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Daniel T P', 'Initials': 'DTP', 'LastName': 'Fong', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",Bone & joint open,['10.1302/2633-1462.18.BJO-2020-0096']
2520,33211598,"Walking exercise alters protein digestion, amino acid absorption, and whole body protein kinetics in older adults with and without COPD.","PURPOSE


Gut symptoms and markers of gut dysfunction have been observed in patients with Chronic Obstructive Pulmonary disease (COPD). It remains unclear whether walking exercise induces disturbances in protein digestion and amino acid absorption and whole body protein kinetics in these subjects due to exercise induced hypoxia.
METHODS


Sixteen clinically stable patients with moderate to very severe COPD and 12 age matched control subjects completed the study. Protein digestion and amino acid absorption and whole body protein kinetics, in the postabsorptive state, were measured via a continuous infusion of stable tracers in combination with orally administered tracer sips during 20 minutes of walking exercise and up to 4 hours post-exercise. COPD patients completed one study day, walking at maximal speed, while healthy subjects completed two, one matched to the speed of a COPD patient and one walking at maximal speed.
RESULTS


The COPD patients tolerated 20 minutes of vigorous intensity walking despite elevated heart rate (P<0.001) and substantial desaturation (P<0.001). Relative to rest, protein digestion was increased during recovery from exercise (P<0.05) while amino acid absorption was reduced during (P<0.0001) and immediately after exercise (P<0.001). Whole body protein breakdown was reduced within 20 minutes after exercise (P<0.05) and stayed suppressed for four hours (P<0.0001). Whole body net protein breakdown was elevated for four hours post-exercise (P<0.001).
CONCLUSION


Our data showed that 20 minutes of walking exercise is sufficient to cause substantial perturbations in gut function in older adults and COPD patients with hypoxia as a potential underlying factor.",2020,"Relative to rest, protein digestion was increased during recovery from exercise (P<0.05) while amino acid absorption was reduced during (P<0.0001) and immediately after exercise (P<0.001).","['older adults with and without COPD', 'patients with Chronic Obstructive Pulmonary disease (COPD', 'Sixteen clinically stable patients with moderate to very severe COPD and 12 age matched control subjects completed the study', 'older adults and COPD patients with hypoxia', 'COPD patients']","['walking exercise', 'Walking exercise']","['Whole body net protein breakdown', 'Whole body protein breakdown', 'COPD patients tolerated 20 minutes of vigorous intensity walking despite elevated heart rate', 'amino acid absorption', 'Protein digestion and amino acid absorption and whole body protein kinetics', 'Relative to rest, protein digestion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",16.0,0.0328479,"Relative to rest, protein digestion was increased during recovery from exercise (P<0.05) while amino acid absorption was reduced during (P<0.0001) and immediately after exercise (P<0.001).","[{'ForeName': 'Clayton L', 'Initials': 'CL', 'LastName': 'Cruthirds', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, United States.'}, {'ForeName': 'Nicolaas E P', 'Initials': 'NEP', 'LastName': 'Deutz', 'Affiliation': 'Center for Translational Research in Aging & Longevity. Department of Health & Kinesiology, Texas A&M University, United States.'}, {'ForeName': 'Gerdien C', 'Initials': 'GC', 'LastName': 'Ligthart-Melis', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, United States.'}, {'ForeName': 'Sunday Y', 'Initials': 'SY', 'LastName': 'Simbo', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, United States.'}, {'ForeName': 'Marielle P K J', 'Initials': 'MPKJ', 'LastName': 'Engelen', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00783.2020']
2521,33211607,Trauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Follow-Up Findings from an Implementation Randomized Controlled Trial Study.,"Background:  Intimate partner violence (IPV) and reproductive coercion impact women seeking care at family planning (FP) clinics. Interventions to facilitate patient-provider conversations about healthy relationships are needed. We sought to determine the added effect of providing psychoeducational messages to patients compared with tailored provider scripts alone on sexual and reproductive health outcomes at 4-6 months.  Methods:  We randomized participants to Trauma-Informed Personalized Scripts (TIPS)-Plus (provider scripts +patient messages) or TIPS-Basic (provider scripts only) at four FP clinics. Eligible patients included English-speaking females aged 16-29 years. Data were collected at initial visits (T1) and 4-6 months (T2) on IPV, reproductive coercion, fear, condom and other contraceptive use, self-efficacy, harm reduction behaviors, and knowledge/use of IPV-related services. We compared frequencies and summary scores between baseline and follow-up with McNemar's test of paired proportions and Signed Rank-Sum, respectively. We compared the difference in differences over time by treatment arm using two-sample  t -tests, and used linear, logistic, and ordinal logistic regression to compare intervention effects at follow-up.  Results:  Two hundred forty patients participated (114 TIPS-Plus, 126 TIPS-Basic), 216 completed follow-up. We detected no differences in outcomes between treatment arms. Between T1 and T2, we observed overall reductions in mean summary scores for reproductive coercion (T1 = 0.08 ± 0.02, T2 = 0.02 ± 0.01,  p  = 0.028) and increases in contraceptive use (69.6%-87.9%,  p  < 0.001), long-acting reversible contraceptives (8.3%-20.8%,  p  < 0.001), and hidden methods (20%-38.5%,  p  < 0.001).  Conclusions:  We show no added benefit of patient-activation messages compared with provider scripts alone. Findings suggest potential utility of provider scripts in addressing reproductive coercion and contraceptive uptake (Trial Registration No. NCT02782728).",2020,"Between T1 and T2, we observed overall reductions in mean summary scores for reproductive coercion (T1 = 0.08 ± 0.02, T2 = 0.02 ± 0.01,  p  = 0.028) and increases in contraceptive use (69.6%-87.9%,  p  < 0.001), long-acting reversible contraceptives (8.3%-20.8%,  p  < 0.001), and hidden methods (20%-38.5%,  p  < 0.001).  ","[':  Intimate partner violence (IPV) and reproductive coercion impact women seeking care at family planning (FP) clinics', 'Two hundred forty patients participated (114 TIPS', 'Eligible patients included English-speaking females aged 16-29 years']","['tailored provider scripts alone', 'Trauma-Informed Personalized Scripts (TIPS)-Plus (provider scripts\u2009+patient messages) or TIPS-Basic (provider scripts only) at four FP clinics']","['contraceptive use', 'IPV, reproductive coercion, fear, condom and other contraceptive use, self-efficacy, harm reduction behaviors, and knowledge/use of IPV-related services', 'sexual and reproductive health outcomes', 'long-acting reversible contraceptives']","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}]",240.0,0.189434,"Between T1 and T2, we observed overall reductions in mean summary scores for reproductive coercion (T1 = 0.08 ± 0.02, T2 = 0.02 ± 0.01,  p  = 0.028) and increases in contraceptive use (69.6%-87.9%,  p  < 0.001), long-acting reversible contraceptives (8.3%-20.8%,  p  < 0.001), and hidden methods (20%-38.5%,  p  < 0.001).  ","[{'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Hill', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Hadas', 'Initials': 'H', 'LastName': 'Zachor', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Talis', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Zelazny', 'Affiliation': 'RAND Corporation, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, UPMC Children's Hospital of Pittsburgh, Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.""}]",Journal of women's health (2002),['10.1089/jwh.2020.8527']
2522,33211674,Comparison of Anterior and Posterior Decompressions in Treatment of Traumatic Thoracolumbar Spinal Fractures Complicated with Spinal Cord Injury.,"BACKGROUND For patients with thoracolumbar spinal fractures complicated with spinal cord injury, timely surgery is the first choice. We compared the effects of anterior and posterior decompressions in treatment of these patients. MATERIAL AND METHODS A total of 80 male patients with traumatic thoracolumbar spinal fractures and spinal cord injury were prospectively selected and divided into 2 groups. The control group underwent posterior decompression and internal fixation and the observation group underwent real-time anterior decompression. RESULTS The observation group had longer operative time and length of postoperative hospital stay, larger intraoperative blood loss, remarkably greater immediate postoperative anterior height and middle column height of the fractured vertebrae, and a notably smaller Cobb's angle than in the control group. The total ASIA score was significantly higher in the observation group than in the control group immediately after surgery and at 6 months and 1 year after surgery. The maximal urine flow, maximal detrusor pressure, and bladder compliance were also evidently higher in the observation group than in the control group during 1 year of follow-up. Compared with the control group, the International Index of Erectile Function-5 (IIEF-5) score in the observation group was significantly higher at 3 months, 6 months, and 1 year after surgery. CONCLUSIONS Compared with the posterior approach, anterior decompression in patients with thoracolumbar spinal fractures complicated with spinal cord injury can effectually enhance the surgical efficiency, and restore the physiological anatomy of the fractured vertebrae, thereby improving patient quality of life.",2020,The total ASIA score was significantly higher in the observation group than in the control group immediately after surgery and at 6 months and 1 year after surgery.,"['80 male patients with traumatic thoracolumbar spinal fractures and spinal cord injury', 'Traumatic Thoracolumbar Spinal Fractures Complicated with Spinal Cord Injury', 'patients with thoracolumbar spinal fractures complicated with spinal cord injury']","['posterior approach, anterior decompression', 'Anterior and Posterior Decompressions', 'posterior decompression and internal fixation and the observation group underwent real-time anterior decompression']","['total ASIA score', 'patient quality of life', 'maximal urine flow, maximal detrusor pressure, and bladder compliance', 'longer operative time and length of postoperative hospital stay, larger intraoperative blood loss', 'International Index of Erectile Function-5 (IIEF-5) score', 'immediate postoperative anterior height and middle column height of the fractured vertebrae']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0205512', 'cui_str': 'Posterior approach'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure'}, {'cui': 'C0429810', 'cui_str': 'Bladder compliance'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C1185738', 'cui_str': 'Column structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}]",80.0,0.0339085,The total ASIA score was significantly higher in the observation group than in the control group immediately after surgery and at 6 months and 1 year after surgery.,"[{'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Orthopedic Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.927284']
2523,33211870,Denosumab Safety and Efficacy Among Subjects in the FREEDOM Extension Study With Mild-to-Moderate Chronic Kidney Disease.,"CONTEXT


Effects of long-term exposure to denosumab in subjects with renal insufficiency are unknown.
OBJECTIVE


This post hoc analysis evaluates the long-term safety and efficacy of denosumab in subjects with mild-to-moderate CKD (stages 2 and 3) using data from the pivotal phase 3, double-blind, 3-year FREEDOM (NCT00089791) and open-label, 7-year extension (NCT00523341) studies.
SUBJECTS AND METHODS


Women aged 60-90 years with bone mineral density (BMD) T-score <-2.5 to >-4.0 at the total hip or lumbar spine were randomized 1:1 to denosumab 60 mg SC Q6M (long-term arm) or placebo (cross-over arm) in FREEDOM; eligible subjects could enroll in the extension to receive denosumab 60 mg SC Q6M. Change in estimated glomerular filtration rate (eGFR) from study baseline and annualized rates of fracture and adverse events (AEs) were the main outcome measures.
RESULTS


Most subjects (1259/1969 [64%] long-term arm; 1173/1781 [66%] crossover arm) with baseline CKD stage 2 or 3 remained within the same CKD subgroup at study completion; <3% progressed to CKD stage 4. Subjects in all eGFR subgroups showed similar, persistent BMD gains over time and a low incidence of fractures. The percentage of subjects reporting serious AEs was similar among renal subgroups (normal, CKD stage 2, CKD stage 3a, CKD stage 3b) for both the long-term (54% vs 52% vs 57% vs 58%) and crossover (43% vs 42% vs 43% vs 68%) arms, except CKD stage 3b subgroup, crossover arm.
CONCLUSION


The safety and efficacy of denosumab did not differ among subjects with mild-to- moderate CKD.",2020,"The percentage of subjects reporting serious AEs was similar among renal subgroups (normal, CKD stage 2, CKD stage 3a, CKD stage 3b) for both the long-term (54% vs 52% vs 57% vs 58%) and crossover (43% vs 42% vs 43% vs 68%) arms, except CKD stage 3b subgroup, crossover arm.
","['subjects with mild-to-moderate CKD (stages 2 and 3', 'subjects with mild-to- moderate CKD', 'Women aged 60-90 years with bone mineral density (BMD) T-score <-2.5 to >-4.0 at the total hip or lumbar spine', 'subjects with renal insufficiency are unknown']","['denosumab 60\xa0mg SC Q6M (long-term arm) or placebo', 'denosumab', 'denosumab 60\xa0mg SC Q6M. Change']","['glomerular filtration rate (eGFR', 'BMD gains', 'safety and efficacy', 'percentage of subjects reporting serious AEs', 'Denosumab Safety and Efficacy']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]",,0.124054,"The percentage of subjects reporting serious AEs was similar among renal subgroups (normal, CKD stage 2, CKD stage 3a, CKD stage 3b) for both the long-term (54% vs 52% vs 57% vs 58%) and crossover (43% vs 42% vs 43% vs 68%) arms, except CKD stage 3b subgroup, crossover arm.
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Broadwell', 'Affiliation': 'Rheumatology and Osteoporosis Specialists, Shreveport, LA, USA.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kendler', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Messina', 'Affiliation': 'University of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Miller', 'Affiliation': 'Colorado Center for Bone Research, Denver, CO, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa851']
2524,33211881,Maternal Capabilities Are Associated with Child Caregiving Behaviors Among Women in Rural Zimbabwe.,"BACKGROUND


Young children require high-quality care for healthy growth and development. We defined ""maternal capabilities"" as factors that influence mothers' caregiving ability (physical and mental health, social support, time, decision-making autonomy, gender norm attitudes, and mothering self-efficacy), and developed survey tools to assess them.
OBJECTIVES


We hypothesized that mothers with stronger capabilities during pregnancy would be more likely to practice improved care behaviors after their child was born.
METHODS


We assessed maternal capabilities among 4667 pregnant women newly enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial. Several improved child-care practices were promoted until 18 mo postpartum, the trial endpoint. Care practices were assessed by survey, direct observation, or transcription from health records during postpartum research visits. We used logistic regression to determine the predictive association between maternal capabilities during pregnancy and child-care practices.
RESULTS


Mothers with more egalitarian gender norm attitudes were more likely to have an institutional delivery [adjusted OR (AOR), 2.06; 95% CI, 1.57-2.69], initiate breastfeeding within 1 h of delivery (AOR, 1.38; 95% CI, 1.03-1.84), exclusively breastfeed (EBF) from birth to 3 mo (AOR, 2.55; 95% CI, 1.95-3.35) and 3-6 mo (AOR, 1.75; 95% CI, 1.36-2.25), and, among households randomized to receive extra modules on sanitation and hygiene, have soap and water at a handwashing station (AOR, 1.76; 95% CI, 1.29-2.39). Mothers experiencing time stress were less likely to EBF from birth to 3 mo (AOR, 0.79; 95% CI, 0.66-0.93). Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37). Depressed mothers were 37% and 33%, respectively, less likely to have an institutional delivery (AOR, 0.63; 95% CI, 0.44-0.88) and a fully immunized child (AOR, 0.67; 95% CI, 0.50-0.90).
CONCLUSIONS


Interventions to reduce maternal depression, time stress, inadequate social support, and inequitable gender norms may improve maternal child caregiving.",2020,"Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37).","['Women in Rural Zimbabwe', '4667 pregnant women newly enrolled in the Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial']",[],"['Mothers experiencing time stress', 'maternal depression, time stress, inadequate social support', 'care behaviors', 'Greater social support', 'initiate breastfeeding within 1 h of delivery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0021279', 'cui_str': 'Infant nutrition'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2364105', 'cui_str': 'Inadequate social support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",4667.0,0.142025,"Greater social support was associated with institutional delivery (AOR, 1.53; 95% CI, 1.37-1.98) and, among mothers randomized to receive extra complementary feeding modules, feeding children a minimally diverse diet (AOR, 1.18; 95% CI, 1.01-1.37).","[{'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Matare', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mduduzi N N', 'Initials': 'MNN', 'LastName': 'Mbuya', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Dickin', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Constas', 'Affiliation': 'Charles H. Dyson School of Applied Economics and Management, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Gretel', 'Initials': 'G', 'LastName': 'Pelto', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stoltzfus', 'Affiliation': 'Program in International Nutrition, Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa255']
2525,33211886,"The efficacy and safety of citrate mixture vs sodium bicarbonate on urine alkalization in Chinese primary gout patients with benzbromarone: a prospective, randomized controlled study.","OBJECTIVES


To compare the efficacy and safety of citrate mixture and sodium bicarbonate on urine alkalization in gout patients under benzbromarone treatment.
METHODS


A prospective, randomized, parallel controlled trial was conducted among 200 gout patients in the dedicated gout clinic of the Affiliated Hospital of Qingdao University. The participants were randomly divided into two groups (1:1), sodium bicarbonate group (3 g/day) and citrate mixture group (7 g/day). All patients were prescribed with 25 mg/day benzbromarone at initiation and maintained at a dose of 50 mg/day. Clinical and biochemical data were collected at each follow-up time point (baseline, weeks 2, 4, 8 and 12).
RESULTS


A total of 182 patients completed the 12-week urine alkalization study. The urine pH value of both groups increased significantly from the baseline to the final follow-up time point (sodium bicarbonate group, 5.50-6.00, P < 0.05; citrate mixture group, 5.53-5.93, P < 0.05). While the comparisons regarding urine pH between treatment groups showed no significant differences for each time point. The estimated glomerular filtration rate (eGFR) dropped significantly after 12 weeks' trial in the sodium bicarbonate group (P < 0.01), while it was comparable between baseline and the last follow-up (P > 0.05) in the citrate mixture group. Results of urine analysis showed that the incident rate of occult blood in the sodium bicarbonate group was higher than that in the citrate mixture group (38 vs 24%, P < 0.05), accompanied by a similar occurrence of kidney stones. After 12-week follow-up, the frequency of twice gout flare in the citrate mixture group was significantly lower than that in sodium bicarbonate group (4 vs 12%, P = 0.037). No treatment-emergent adverse events occurred.
CONCLUSION


The efficacy of citrate mixture on urine alkalization is comparable to sodium bicarbonate under benzbromarone treatment without significant adverse events. Citrate mixture is superior to sodium bicarbonate in lowering the incidence of urine occult blood and the frequency of gout attacks.
TRIAL REGISTRATION


Registered with ChiCTR (http://www.chictr.org.cn), No. ChiCTR1800018518.",2020,"Citrate mixture is superior to sodium bicarbonate in lowering the incidence of urine occult blood and the frequency of gout attacks.
","['gout patients under benzbromarone treatment', '182 patients completed the 12-week urine alkalization study', '200 gout patients in the dedicated gout clinic of the Affiliated Hospital of Qingdao University', 'Chinese primary gout patients with benzbromarone']","['citrate mixture vs sodium bicarbonate', 'Citrate mixture', 'sodium bicarbonate', 'citrate mixture and sodium bicarbonate', 'citrate mixture']","['glomerular filtration rate (eGFR', 'urine pH', 'frequency of twice gout flare', 'kidney stones', 'urine pH value', 'efficacy and safety', 'incident rate of occult blood']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005035', 'cui_str': 'Benzbromarone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}]","[{'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0149896', 'cui_str': 'Primary gout'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028792', 'cui_str': 'Occult blood screening'}]",200.0,0.03432,"Citrate mixture is superior to sodium bicarbonate in lowering the incidence of urine occult blood and the frequency of gout attacks.
","[{'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Xinde', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Zhaotong', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Aichang', 'Initials': 'A', 'LastName': 'Ji', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Tony R', 'Initials': 'TR', 'LastName': 'Merriman', 'Affiliation': 'Institute of Metabolic Diseases, Qingdao University, Qingdao, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa668']
2526,33211921,[The effect of administration of dietary supplement with calcium and vitamins D 3  and B 6  on calcium homeostasis and falls incidence in patients with high fracture risk undergoing medical rehabilitation].,"Elimination of vitamin D and calcium deficiencies is of particular importance in older patients undergoing medical rehabilitation after a serious illness, surgery or injury and having a high risk of fractures. Preventing falls and fractures, including during the course of rehabilitation, is an important challenge that can be addressed in these patients, in particular through improved nutrition and vitamin D and calcium supplementation.  The aim  of the study was to evaluate the effect of long-term intake of a complex dietary supplement with calcium and vitamins D 3  and B 6  on calcium homeostasis and the frequency of falls in patients with high fracture risk undergoing medical rehabilitation.  Material and methods . The study enrolled 109 women and 10 men (mean age 65.5±7.9 years) with high fracture risk who were undergoing medical rehabilitation. After baseline examination, 41 patients have been receiving antiresorptive therapy already comprised group 1, and patients who didn't receive osteoporotic therapy were randomized into groups 2 (n=39) and 3 (control, n=39). Patients in groups 1 and 2 for 12 months were prescribed a dietary supplement containing calcium in a daily dose of 200 mg (in the form of citrate 1000 mg), 600 IU of vitamin D 3  and 2 mg of vitamin B 6 . All patients underwent assessment of bone mineral density (BMD), calculation of absolute 10-year fracture risk according to FRAX, assessment of food calcium intake, etermination of biochemical parameters of calcium-phosphorus metabolism and bone remodeling (total calcium, inorganic phosphorus, alkaline phosphatase activity - by colorimetric method in blood serum; immunoreactive parathyroid hormone (PTH) and osteocalcin - by electrochemiluminescence immunoassay in blood serum; β-isomer of C-terminal telopeptide of type I collagen (CTx) and 25(OH)D in blood plasma - by immunochemiluminescence analysis), cases of falls and fractures were fixed.  Results . Average daily intake of calcium in the studied sample (n=119) was 782.9±243.4 mg, and 67.2% of patients consumed less than 800 mg of calcium daily. Vitamin D deficit was detected in 38.4% of the examined, its insufficiency - in 32.8%. An increase in 25(OH)D concentration was noted in groups 1 and 2 after 6 and 12 months (p<0.01), while in group 3 there was no dynamics of 25(OH)D (p>0.05). Patients in group 1 showed an increase in the level of osteocalcin and total calcium after 6 and 12 months, as well as alkaline phosphatase activity after 6 months (p<0.05). In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05). In group 1, there was an increase in BMD in the spine (+4.2%, p=0.024), femoral neck (+3.0%, p=0.041), and total femur (+2.7%, p=0.045), in patients of group 2 - an increase in BMD in the spine (+1.8%, p=0.048). In group 1, there was also a decrease in proportion of patients who fell after 6 months (χ 2 =4.97, p=0.026) and a decrease in the total number of falls after 12 months (χ 2 =4.89, p=0.027). Group 2 showed a decrease in the number of patients who fell after 6 and 12 months (χ 2 =48.58, p=0.0034 at both stages of the study) and the number of falls in general after 6 months (χ 2 =6.02, p=0.0142).  Conclusion . The obtained data allow us to recommend prescription of dietary supplements containing calcium and vitamin D 3  as a part of complex rehabilitation of patients with high fracture risk.",2020,"In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05).","['patients with high fracture risk undergoing medical rehabilitation', ""41 patients have been receiving antiresorptive therapy already comprised group 1, and patients who didn't receive osteoporotic therapy"", 'patients with high fracture risk', 'older patients undergoing medical rehabilitation after a serious illness, surgery or injury and having a high risk of fractures', '109 women and 10 men (mean age 65.5±7.9 years) with high fracture risk who were undergoing medical rehabilitation']","['vitamin D and calcium deficiencies', 'complex dietary supplement with calcium and vitamins D 3  and B 6', 'dietary supplement containing calcium', 'vitamin D 3  and 2 mg of vitamin B 6 ', 'dietary supplement with calcium and vitamins D 3  and B 6']","['bone mineral density (BMD), calculation of absolute 10-year fracture risk according to FRAX, assessment of food calcium intake, etermination of biochemical parameters of calcium-phosphorus metabolism and bone remodeling (total calcium, inorganic phosphorus, alkaline phosphatase activity - by colorimetric method in blood serum; immunoreactive parathyroid hormone (PTH) and osteocalcin - by electrochemiluminescence immunoassay in blood serum; β-isomer of C-terminal telopeptide of type I collagen (CTx) and 25(OH)D in blood plasma - by immunochemiluminescence analysis), cases of falls and fractures', '25(OH)D concentration', 'Average daily intake of calcium', 'alkaline phosphatase activity', 'BMD', 'total femur', 'CTx and alkaline phosphatase activity', 'femoral neck', 'calcium homeostasis and falls incidence', 'level of osteocalcin and total calcium', 'total number of falls', 'Vitamin D deficit', 'number of falls', 'PTH levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0392519', 'cui_str': 'Calcium deficiency'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay method'}, {'cui': 'C0022203', 'cui_str': 'Isomerism'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3653518', 'cui_str': 'CALCIUM HOMEOSTASIS'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",109.0,0.0433026,"In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05).","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Marchenkova', 'Affiliation': 'National Medical Research Center of Rehabilitation and Balneology of Ministry of Health of Russian Federation, 121099, Moscow, Russian Federation.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Fesyun', 'Affiliation': 'National Medical Research Center of Rehabilitation and Balneology of Ministry of Health of Russian Federation, 121099, Moscow, Russian Federation.'}, {'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Gerasimenko', 'Affiliation': 'Russian Medical Academy of Continuing Professional Education, 125993, Moscow, Russian Federation.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Makarova', 'Affiliation': 'National Medical Research Center of Rehabilitation and Balneology of Ministry of Health of Russian Federation, 121099, Moscow, Russian Federation.'}]",Voprosy pitaniia,['10.24411/0042-8833-2020-10069']
2527,33212138,Thirst perception exacerbates objective mental fatigue.,"Thirst is represented within the anterior cingulate and insular cortices, and may share some common neuroanatomical structures that are implicated with the regulation of mental fatigue. This novel study investigated whether thirst might modulate the subjective, behavioural, or neurophysiological representations of mental fatigue. In a crossover design, thirst was monitored in 15 males during 60 mins of cycling in normothermic conditions. Participants either consumed water to the dictates of their thirst (sated), or fluid was withheld and replaced with periodic salt water mouth rinses (thirst). Following either satiety or thirst, a 60 min modified Stroop task was completed to evoke mental fatigue. Prefrontal cortex (PFC) haemodynamics were monitored throughout the prolonged task, and subjective perceptions of fatigue were reported through a visual analogue scale. Behavioural performance was quantified as the total number of Stroop task iterations completed in the mentally fatiguing task, and by collating response time and accuracy into the inverse efficiency score (IES) for each 5 min interval throughout the task. During thirst, fewer iterations were completed and poorer IES performance was evident toward the latter portion of the mentally fatiguing task. Compensatory elevations in PFC oxyhaemoglobin were produced in each condition, however, differed temporally, and were premature during thirst. A diminished capacity to sustain cognitive performance is likely the product of an inability to preserve the distribution of resources within the prefrontal cortex, due to heightened activation about thirst regulatory centres. These data provide novel insight into the relationship between thirst and mental fatigue, and suggest that drinking to the dictates of thirst may be a pertinent strategy to sustain prolonged cognitive performance.",2020,"Compensatory elevations in PFC oxyhaemoglobin were produced in each condition, however, differed temporally, and were premature during thirst.",['15 males during 60 mins of cycling in normothermic conditions'],[],"['total number of Stroop task iterations', 'Behavioural performance', 'IES performance', 'Thirst perception exacerbates objective mental fatigue', 'subjective, behavioural, or neurophysiological representations of mental fatigue', 'Prefrontal cortex (PFC) haemodynamics']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.0288152,"Compensatory elevations in PFC oxyhaemoglobin were produced in each condition, however, differed temporally, and were premature during thirst.","[{'ForeName': 'Stephen P J', 'Initials': 'SPJ', 'LastName': 'Goodman', 'Affiliation': 'School of Exercise Science, Sport & Health, Charles Sturt University, Bathurst, Australia; School of Science and Technology, University of New England, Armidale, Australia. Electronic address: stephen.goodman@une.edu.au.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Marino', 'Affiliation': 'School of Exercise Science, Sport & Health, Charles Sturt University, Bathurst, Australia. Electronic address: fmarino@csu.edu.au.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107686']
2528,33212205,Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial.,"RATIONALE & OBJECTIVE


Although maintaining high fluid intake is an effective, low-risk intervention for the secondary prevention of urinary stone disease (USD), many stone patients do not increase their fluid intake.
STUDY DESIGN


We describe the rationale and design of the Prevention of Urinary Stones with Hydration (PUSH) study, a randomized trial of a multi-component behavioral intervention program to increase and maintain high fluid intake. Participants are randomized (1:1 ratio) to intervention or control arm. The target sample size is 1642 participants.
SETTING & PARTICIPANTS


Adults and adolescents ≥12 years of age with a symptomatic stone history and low urine volume are eligible. Exclusion criteria include infectious or monogenic causes of USD and comorbid conditions precluding increased fluid intake.
INTERVENTIONS


All participants receive usual care and a smart water bottle and smartphone application. Participants in the intervention arm receive a fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions. Control arm participants receive guideline-based fluid instructions.
OUTCOMES


The primary endpoint is recurrence of a symptomatic stone over 24-months of follow-up. Secondary endpoints include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.
LIMITATIONS


Periodic 24-hour urine volumes may not fully reflect daily behavior.
CONCLUSIONS


With its highly novel features, the PUSH study will address an important healthcare problem.",2020,"Secondary endpoints include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.
","['Adults and adolescents ≥12 years of age with a symptomatic stone history and low urine volume are eligible', '1642 participants']","['usual care and a smart water bottle and smartphone application', 'multi-component behavioral intervention program', 'guideline-based fluid instructions', 'fluid intake prescription and an adaptive program of behavioral interventions, including financial incentives, structured problem solving, and other automated adherence interventions', 'Urinary Stones with Hydration (PUSH', 'Urinary Stones With Hydration (PUSH']","['recurrence of a symptomatic stone over 24-months of follow-up', 'changes in radiographic stone burden, 24-hour urine output, and urinary symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}]","[{'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0429776', 'cui_str': '24 hour urine output'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",,0.147676,"Secondary endpoints include changes in radiographic stone burden, 24-hour urine output, and urinary symptoms.
","[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Scales', 'Affiliation': 'Urologic Surgery and Population Health Science, Duke Surgical Center for Outcomes Research, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: Chuck.scales@duke.edu.'}, {'ForeName': 'Alana C', 'Initials': 'AC', 'LastName': 'Desai', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Harper', 'Affiliation': 'Department of Urology, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Lai', 'Affiliation': 'Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Naim M', 'Initials': 'NM', 'LastName': 'Maalouf', 'Affiliation': 'Department of Internal Medicine and Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Reese', 'Affiliation': 'Renal-Electrolyte and Hypertension Division; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Department of Biostatistics, Epidemiology, and Informatics; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Tasian', 'Affiliation': ""Department of Biostatistics, Epidemiology, and Informatics; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Surgery, Division of Pediatric Urology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kirkali', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Wessells', 'Affiliation': 'Department of Urology, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.09.016']
2529,33212231,How effective is periarticular multimodal drug injection in open elbow arthrolysis? A prospective double-blind randomized controlled trial.,"BACKGROUND


Evidence on the efficacy and safety of periarticular multimodal drug injection (PMDI) in open elbow arthrolysis (OEA) is limited. This study aimed to investigate differences in postoperative pain, blood loss and range of motion (ROM) between PMDI versus no injection among patients undergoing OEA, and the presence of PMDI-related complications.
METHODS


This prospective, double-blind randomized controlled trial included 59 patients who underwent OEA. Patients randomly received PMDI (ropivacaine, epinephrine, ketoprofen) prior to wound closure or no injection. The primary outcomes were elbow pain over the first postoperative week at rest and during motion, measured using the visual analog scale (VAS). VAS scores were compared to attain the 20-mm threshold values for a minimum clinically important difference. Parecoxib consumption on OEA night and postoperative day (POD)1-3 and total consumption during the first postoperative week were recorded. Blood loss was recorded every 24 hours until POD3. ROM during rehabilitation was measured daily from day one to day seven post-surgery, as well as at 3-month follow-up. Medication-related side effects were recorded prospectively.
RESULTS


The mean VAS score showed clinically important differences between PMDI and control groups at rest on OEA night (mean difference (MD), 25 mm; p<0.001) and first three PODs with motion (POD1: MD 28 mm, p<0.001; POD2: MD 21 mm, p<0.001; POD3: MD 21 mm, p<0.001), but not in other postoperative assessments. Parecoxib consumption was lower in the PMDI group on OEA night and POD1-3. Total parecoxib consumption during the first postoperative week was lower in the PMDI group vs. control group (MD, 148 mg; p<0.001). Blood drainage was less in the PMDI group vs. control group on POD1 (MD, 38 mL; p=0.016), but not on POD2 (p=0.950), POD3 (p=0.259), or total (p=0.184). The PMDI group exhibited significantly better ROM during the first four PODs than the control group, while no difference at 3-month follow-up. No medication-related side effects were noted in the PMDI group.
CONCLUSION


PMDI effectively relieves pain and reduces analgesic consumption for OEA patients, without apparent increase in risks.",2020,"Total parecoxib consumption during the first postoperative week was lower in the PMDI group vs. control group (MD, 148 mg; p<0.001).","['patients undergoing OEA, and the presence of PMDI-related complications', '59 patients who underwent OEA']","['Parecoxib', 'PMDI (ropivacaine, epinephrine, ketoprofen) prior to wound closure or no injection', 'periarticular multimodal drug injection (PMDI']","['Blood loss', 'Parecoxib consumption', 'Blood drainage', 'elbow pain over the first postoperative week at rest and during motion, measured using the visual analog scale (VAS', 'ROM', 'postoperative pain, blood loss and range of motion (ROM', 'side effects', 'Total parecoxib consumption', 'pain and reduces analgesic consumption', 'VAS scores', 'mean VAS score', 'OEA night and postoperative day (POD)1-3 and total consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0239266', 'cui_str': 'Pain in elbow'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C1283023', 'cui_str': 'Arthrolysis'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",59.0,0.311479,"Total parecoxib consumption during the first postoperative week was lower in the PMDI group vs. control group (MD, 148 mg; p<0.001).","[{'ForeName': 'Ziyang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China.""}, {'ForeName': 'Juehong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China.""}, {'ForeName': 'Haomin', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China.""}, {'ForeName': 'Weixuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China.""}, {'ForeName': 'Cunyi', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': ""Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China. Electronic address: cyfan@sjtu.edu.cn.""}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.10.012']
2530,33212239,The impact of patient self-monitoring via electronic medication monitor and mobile app plus remote clinician feedback on adherence to inhaled corticosteroids: A randomized controlled trial.,"BACKGROUND


Poor adherence to inhaled corticosteroids (ICS) and overuse of short-acting beta 2 -agonists (SABA) are associated with increased asthma morbidity.
OBJECTIVE


To assess whether patient self-monitoring via electronic medication monitoring (EMM) and smartphone application plus remote clinician feedback influences ICS and SABA use.
METHODS


Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study. Inhalers were fitted with EMM to track real-time usage. After a 14-day baseline, participants were randomly assigned to the treatment group where they received reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback. Linear mixed models compared the baseline percent of SABA-free days and ICS adherence to the last 14 study days.
RESULTS


Participants (n=100) had a mean age of 48.5 years, 80% were female, 68% Caucasian and 80% privately insured. The percent of SABA-free days increased significantly in the treatment group (19%, 95% CI: 12, 26; P < 0.01) and non-significantly in the control group (6%, 95% CI: -3, 16; P = 0.18), representing a 13% (95% CI: 1, 26; P = 0.04) difference. ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference.
CONCLUSIONS


Patient self-monitoring via a digital platform plus remote clinician feedback, maintained high baseline ICS adherence and decreased SABA use. ClinicalTrials.gov (NCT03860519).",2020,"ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference.
","['Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study', 'Participants (n=100) had a mean age of 48.5 years, 80% were female, 68% Caucasian and 80% privately insured']","['corticosteroids', 'patient self-monitoring via electronic medication monitor and mobile app plus remote clinician feedback', 'reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback', 'patient self-monitoring via electronic medication monitoring (EMM) and smartphone application plus remote clinician feedback', 'inhaled corticosteroids (ICS']","['percent of SABA-free days', 'ICS adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.251684,"ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference.
","[{'ForeName': 'Giselle S', 'Initials': 'GS', 'LastName': 'Mosnaim', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois. Electronic address: Gmosnaim@northshore.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stempel', 'Affiliation': 'Propeller Health affiliate of ResMed, San Francisco, California.'}, {'ForeName': 'Candy', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Adams', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'BenIsrael-Olive', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Gondalia', 'Affiliation': 'ResMed, San Francisco, California.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Kaye', 'Affiliation': 'ResMed, San Francisco, California.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Shalowitz', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Section of Allergy and Immunology and Pulmonary and Sleep Medicine, University of Colorado School of Medicine and the Breathing Institute, Children's Hospital Colorado, Aurora, Colorado.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.064']
2531,32818966,Effect of Tribochemical Coating on Composite Repair Strength.,"CLINICAL RELEVANCE


Tribochemical treatment of existing composite surfaces is highly effective for composite repair. When repairing an old composite restoration, the clinician should try to use the same composite originally used for the restoration. If the information about the original restoration is not known, a composite with strong mechanical properties should be used for the repair restoration.
SUMMARY


This study evaluated the effect of tribochemical coating on composite-to-composite repair interfacial fracture toughness (iFT). Sixty beam-shaped specimens (21×4×3 ± 0.2 mm) were prepared with a nanofill composite (Filtek Supreme Ultra [FSU]) and a nanohybrid composite (Clearfil Majesty ES-2 [CME]) and aged for 50,000 thermocycles (5°C-55°C, 20-second dwell time) and then sectioned in half. The resulting 120 hemispecimens (60 for each composite) were randomly assigned to different repair methods (n=10): universal adhesive (Clearfil Universal Bond Quick [CUB]), sand-blasting followed by CUB, or tribochemical coating (CoJet, CoJet sand, Espe-Sil, and Visio-Bond). The repair surface was prepared with a diamond bur (Midwest #471271), rinsed, and dried. Each aged composite brand (FSU, CME) was repaired with either the same composite or the opposite composite. All adhesives and composites were light cured with a high-irradiance LED curing light (Elipar DeepCure-S). After postrepair storage in 100% humidity and at 37°C for 24 hours, iFT was measured as KIc (MPa m½). Data were analyzed for statistical significance using two-way analysis of variance (ANOVA) and the Tukey honest significant difference post hoc test (α=0.05). Regardless of the substrate composite, ANOVA showed significant differences for surface treatment (p<0.0001) and repair composite (p<0.0001). Mean iFT values (SD) ranged from 0.91 (0.10) MPa·m½ to 2.68 (0.12) MPa·m½. Repairs made with FSU after CoJet resulted in significantly higher iFT (FSU: 2.68 MPa·m½; CME: 2.21 MPa·m½) when compared to the other experimental groups. The repair iFT was higher with CoJet treatment and when the nanofill composite FSU was used as the repair composite.",2020,"Regardless of the substrate composite, ANOVA showed significant differences for surface treatment (p<0.0001) and repair composite (p<0.0001).",['120 hemispecimens (60 for each composite'],"['Tribochemical Coating', 'nanofill composite (Filtek Supreme Ultra [FSU]) and a nanohybrid composite (Clearfil Majesty ES-2 [CME', 'universal adhesive (Clearfil Universal Bond Quick [CUB]), sand-blasting followed by CUB, or tribochemical coating (CoJet, CoJet sand, Espe-Sil, and Visio-Bond', 'tribochemical coating']","['Mean iFT values', 'Composite Repair Strength', 'repair iFT']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3884244', 'cui_str': 'Filtek Supreme Ultra'}, {'cui': 'C2716631', 'cui_str': 'clearfil majesty'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010435', 'cui_str': 'Cuba'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0217222', 'cui_str': 'Visio-Bond'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.0286317,"Regardless of the substrate composite, ANOVA showed significant differences for surface treatment (p<0.0001) and repair composite (p<0.0001).","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Ritter', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sulaiman', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Altitinchi', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Baratto-Filho', 'Affiliation': ''}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Gonzaga', 'Affiliation': ''}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Correr', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-145-L']
2532,33212267,Photodynamic therapy and Acyclovir in the treatment of recurrent herpes labialis: a controlled randomized clinical trial.,"BACKGROUND


Herpes Simplex Virus Type 1 (HSV-1) is one of the most widespread infections that affect the orofacial region. Its recurrent infection is considered a life-long oral health problem, leading to frequent pain, discomfort, and social restriction due to esthetic features. Foremost, the development of new therapies is encouraged. This study aimed to compare photodynamic therapy (PDT), Topical Acyclovir (AC), and the association of both in the healing process and self-reported symptomologies of HSV-1 recurrences.
METHODS


Patients were randomly assigned into 3 groups (n = 25): PDT (low-power laser, 660 nm, 40 mW, 120 J/cm 2 , 4.8 J, 120 s per point) and methylene blue (0.005%) as photosensitizer; AC (5%); PDT + AC. Data concerning lesion size, healing time, and self-reported healing parameters, such as pain, tingling, and edema were taken every day up to complete healing for all studied groups.
RESULTS


There was no significant difference in healing time and pain between groups. AC group showed a significant minor reduction of the lesion compared to the AC-PDT group on day 1. Regarding edema and tingling, the comparison of treatments showed a statistical difference only on day 1, where PDT showed better results.
CONCLUSION


With all the limitations of this study, it can be concluded that only on day 1 that PDT showed positive effects in the treatment of herpes lesions in comparison to AC.",2020,"Regarding edema and tingling, the comparison of treatments showed a statistical difference only on day 1, where PDT showed better results.
","['recurrent herpes labialis', 'Patients']","['Photodynamic therapy and Acyclovir', 'photodynamic therapy (PDT), Topical Acyclovir (AC']","['lesion size, healing time, and self-reported healing parameters, such as pain, tingling, and edema', 'healing time and pain']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",,0.0311996,"Regarding edema and tingling, the comparison of treatments showed a statistical difference only on day 1, where PDT showed better results.
","[{'ForeName': 'Karen Müller', 'Initials': 'KM', 'LastName': 'Ramalho', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP, Brazil; Universidade de São Paulo, Faculdade de Odontologia, Av. Professor Lineu Prestes, 2227, São Paulo, SP, Brazil. Electronic address: karenramalho@hotmail.com.'}, {'ForeName': 'Sandra Ribeiro', 'Initials': 'SR', 'LastName': 'Cunha', 'Affiliation': 'University of Iowa, College of Dentistry, 801 Newton Rd, Iowa City, IA, United States.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP, Brazil.'}, {'ForeName': 'Gustavo Silva', 'Initials': 'GS', 'LastName': 'Escudeiro', 'Affiliation': 'Universidade Ibirapuera, Av. Interlagos, 1329, São Paulo, SP, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Steiner-Oliveria', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia, Av. Limeira, 901, Piracicaba, SP, Brazil.'}, {'ForeName': 'Anna Carolina Rato Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, University Nove de Julho (UNINOVE), São Paulo, Brazil.'}, {'ForeName': 'Carlos de Paula', 'Initials': 'CP', 'LastName': 'Eduardo', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia, Av. Professor Lineu Prestes, 2227, São Paulo, SP, Brazil.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102093']
2533,33212271,Relationship of Topographic Distribution of Geographic Atrophy to Visual Acuity in Nonexudative Age-Related Macular Degeneration.,"PURPOSE


To investigate the topographic distribution of geographic atrophy (GA) and to identify a continuous anatomic endpoint that correlates with visual acuity (VA) in eyes with GA.
DESIGN


Retrospective analysis of a multicenter, prospective, randomized controlled trial.
PARTICIPANTS


The Age-Related Eye Disease Study (AREDS) participants with GA secondary to nonexudative age-related macular degeneration.
METHODS


We manually delineated GA on 1654 fundus photographs of 365 eyes. We measured GA areas in 9 macular subfields in Early Treatment for Diabetic Retinopathy Study (ETDRS) grid and correlated them with VA via a mixed-effects model. We determined the optimal diameter for the central zone by varying the diameter from 0 to 10 mm until the highest r2 between GA area in the central zone and VA was achieved. We estimated the VA decline rate over 8 years using a linear mixed model.
MAIN OUTCOME MEASURES


GA area in macular subfields and VA.
RESULTS


The percentage of area affected by GA declined as a function of retinal eccentricity. GA area was higher in the temporal than nasal region (1.30 ± 1.75 vs. 1.10 ± 1.62 mm 2 ; P = 0.005), and in the superior than inferior region (1.26 ± 1.73 vs. 1.03 ± 1.53 mm 2 ; P < 0.001). Total GA area correlated poorly with VA (r 2  = 0.07). Among GA areas in 9 subfields, only GA area in the central zone was independently associated with VA (P < 0.001). We determined 1 mm as the optimal diameter for the central zone, in which GA area correlated best with VA (r 2  = 0.45). On average, full GA coverage of the central 1-mm-diameter zone corresponded to 34.8 ETDRS letters decline in VA. The VA decline rate was comparable between eyes with initial noncentral and central GA before GA covered the entire central 1-mm-diameter zone (2.7 vs. 2.8 ETDRS letters/year; P = 0.94).
CONCLUSIONS


The prevalence of GA varies significantly across different macular regions. Although total GA area was poorly associated with VA, GA area in the central 1-mm-diameter zone was significantly correlated with VA and may serve as a surrogate endpoint in clinical trials.",2020,"GA area was higher in the temporal than nasal region (1.30 ± 1.75 vs. 1.10 ± 1.62 mm 2 ; P = 0.005), and in the superior than inferior region (1.26 ± 1.73 vs. 1.03 ± 1.53 mm 2 ; P < 0.001).","['We manually delineated GA on 1654 fundus photographs of 365 eyes', 'The Age-Related Eye Disease Study (AREDS) participants with GA secondary to nonexudative age-related macular degeneration', 'eyes with GA', 'Nonexudative Age-Related Macular Degeneration']",[],"['VA decline rate', 'GA area', 'GA area in macular subfields and VA', 'Total GA']","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271083', 'cui_str': 'Nonexudative age-related macular degeneration'}]",[],"[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",1654.0,0.152891,"GA area was higher in the temporal than nasal region (1.30 ± 1.75 vs. 1.10 ± 1.62 mm 2 ; P = 0.005), and in the superior than inferior region (1.26 ± 1.73 vs. 1.03 ± 1.53 mm 2 ; P < 0.001).","[{'ForeName': 'Liangbo L', 'Initials': 'LL', 'LastName': 'Shen', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Molecular Biophysics and Biochemistry, Yale University, New Haven, CT.'}, {'ForeName': 'Aneesha', 'Initials': 'A', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Toth', 'Affiliation': 'Department of Ophthalmology, Duke University School of Medicine, Durham, NC; Department of Biomedical Engineering, Pratt School of Engineering, Duke University, Durham, NC.'}, {'ForeName': 'Eleonora M', 'Initials': 'EM', 'LastName': 'Lad', 'Affiliation': 'Department of Ophthalmology, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lucian V', 'Initials': 'LV', 'LastName': 'Del Priore', 'Affiliation': 'Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, CT. Electronic address: lucian.delpriore@yale.edu.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.11.003']
2534,33212313,Limb and component alignment after total knee arthroplasty comparing 28 consecutive iAssist and 28 conventional TKAs: A prospective study.,"BACKGROUND


The objective of this study was to assess limb and component alignment after total knee arthroplasty (TKA) on long leg X-rays and to compare the use of iAssist, an accelerometric based computer-assisted device (CAD), with conventional jigs.
METHODS


We prospectively recruited 56 consecutive patients undergoing primary unilateral TKA by a single surgeon into this study. In the first 28 patients iAssist navigation system was utilized and in the following 28 conventional jigs were used. The groups were comparable with regard to age, sex distribution, body mass index and preoperative hip-knee-ankle (HKA) angle. Our aim was to restore neutral coronal alignment and a five degree tibial slope.
RESULTS


The mean postoperative mechanical axis was 179.4° in the CAD group and 180.1° in the conventional group (P = 0.187). There were five TKAs deviating more than three degrees from neutral (18.5%) in the conventional group and none in the CAD group (P = 0.051). The mean femoral mechanical-condyles-angle was significantly closer (P < 0.001) to our target of 90° in the conventional group but contained more outliers (P = 0.67). The sagittal tibial slope was closer (P = 0.047) to our target of 85° in CAD-navigated TKAs with fewer outliers (P < 0.0001). The Oxford Knee Score showed comparable (P = 0.271) and good clinical outcome in both groups. The mean operation time was significantly longer in the CAD group (P < 0.001).
CONCLUSIONS


This study shows that the use of iAssist accelerometric CAD facilitates comparable good leg alignment after TKA in the frontal plane and more accurate tibial slope with fewer outliers in the sagittal plane compared with a conventional technique. Our operation time was longer with CAD.",2020,The mean femoral mechanical-condyles-angle was significantly closer (P < 0.001) to our target of 90° in the conventional group but contained more outliers (P = 0.67).,"['total knee arthroplasty comparing 28 consecutive iAssist and 28', '56 consecutive patients undergoing primary unilateral TKA by a single surgeon into this study']","['accelerometric based computer-assisted device (CAD), with conventional jigs', 'conventional TKAs', 'iAssist accelerometric CAD', 'total knee arthroplasty (TKA']","['Oxford Knee Score', 'mean postoperative mechanical axis', 'mean femoral mechanical-condyles-angle', 'sagittal tibial slope', 'mean operation time']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0524414', 'cui_str': 'Structure of condyle'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",56.0,0.0275162,The mean femoral mechanical-condyles-angle was significantly closer (P < 0.001) to our target of 90° in the conventional group but contained more outliers (P = 0.67).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ehrendorfer', 'Affiliation': 'Department of Orthopaedic Surgery, Spital Buelach, Switzerland. Electronic address: stefan.ehrendorfer@spitalbuelach.ch.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Erdmenger', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Leidy Martinez', 'Initials': 'LM', 'LastName': 'Bocanegra', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Canal', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Canal', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Hoch', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Baden (KSB), Baden, Switzerland.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'University Department Orthopaedics and Trauma Surgery, AKH, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Niehaus', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Baden (KSB), Baden, Switzerland.'}]",The Knee,['10.1016/j.knee.2020.07.101']
2535,33215493,Oral Colonisation after the Administration of Drops Containing Lactobacillus reuteri.,"PURPOSE


To investigate the oral colonisation potential after four weeks' administration of Lactobacillus reuteri and to examine the short-term effect of probiotics on salivary Streptococcus mutans and lactobacilli.
MATERIALS AND METHODS


The study group comprised 13 young adults who volunteered after receiving verbal and written information. The short-term prospective clinical trial lasted 9 weeks, consisting of a 4-week intervention period with administration twice daily and a 5-week post-administration follow-up period with no probiotic consumption. Saliva and dental biofilm samples were obtained immediately before probiotic administration, after 2 weeks and after 4 weeks of L. reuteri administration. Follow-up samples were collected once every week on a regular basis after administration was terminated. The numbers of salivary S. mutans and lactobacilli were assessed by regular plating, while the presence of the two L. reuteri strains in saliva and dental biofilm was evaluated using quantitative polymerase chain reaction (qPCR).
RESULTS


The occurrence of L. reuteri in the oral cavity increased gradually during the intervention period and reached the maximum level after four weeks of probiotic administration (p < 0.0001). The 4-week samples of stimulated whole saliva showed a statistically significant decrease in the number of S. mutans and a statistically significant increase in the salivary lactobacilli level in comparison to baseline. qPCR showed that the DSM 17938 strain has better colonisation for both saliva and dental biofilm than the ATCC PTA 5289 strain at the nine-week follow-up.
CONCLUSION


Probiotics have the ability to colonise the oral cavity during usage, but it gradually disappears after the completion of intake. It also has ability to decrease the number of salivary S. mutans.",2020,"qPCR showed that the DSM 17938 strain has better colonisation for both saliva and dental biofilm than the ATCC PTA 5289 strain at the nine-week follow-up.
",['13 young adults who volunteered after receiving verbal and written information'],['probiotics'],"['Oral Colonisation', 'salivary lactobacilli level', 'occurrence of L. reuteri in the oral cavity', 'number of S. mutans', 'maximum level', 'numbers of salivary S. mutans and lactobacilli', 'Saliva and dental biofilm samples']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0319071,"qPCR showed that the DSM 17938 strain has better colonisation for both saliva and dental biofilm than the ATCC PTA 5289 strain at the nine-week follow-up.
","[{'ForeName': 'Sahal', 'Initials': 'S', 'LastName': 'Alforaidi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bresin', 'Affiliation': ''}, {'ForeName': 'Naif', 'Initials': 'N', 'LastName': 'Almosa', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lehrkinder', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45523']
2536,33215533,Efficacy of Soy-Based Formulas in Alleviating Gastrointestinal Symptoms in Infants With Milk-Based Formula Intolerance: A Randomized Clinical Trial.,"A randomized, blinded pilot clinical study was conducted to assess gastrointestinal (GI) tolerance in healthy, full-term infants (2-9 weeks old), whose pediatricians recommended a formula change due to perceived cow's milk formula intolerance. Infants were randomized and exclusively fed either a commercial control soy formula (SF; n = 22), an experimental partially hydrolyzed SF (10% hydrolyzed, n = 23), or a 5% hydrolyzed SF (n = 26) for 2 weeks. Age-matched reference cohorts (n = 72) with no GI intolerance on milk-based formula were assessed in parallel. Results indicated that all SF-fed groups contributed to reduction ( P  < .05) in common GI tolerance symptoms to levels not different from the non-symptomatic reference cohort at study end. The control SF group had more reduced fussiness, gas, and crying and higher formed stools versus hydrolyzed SF groups. In conclusion, the study suggests that SFs reduced GI intolerance symptoms in otherwise healthy infants with poor tolerance on milk-based formulas.",2020,Results indicated that all SF-fed groups contributed to reduction ( P  < .05) in common GI tolerance symptoms to levels not different from the non-symptomatic reference cohort at study end.,"[""healthy, full-term infants (2-9 weeks old), whose pediatricians recommended a formula change due to perceived cow's milk formula intolerance"", 'Infants With Milk-Based Formula Intolerance', 'otherwise healthy infants with poor tolerance on milk-based formulas', 'Age-matched reference cohorts (n = 72) with no GI intolerance on milk-based formula were assessed in parallel']","['experimental partially hydrolyzed SF (10% hydrolyzed, n = 23), or a 5% hydrolyzed SF', 'commercial control soy formula', 'Soy-Based Formulas']","['GI intolerance symptoms', 'Gastrointestinal Symptoms', 'gastrointestinal (GI) tolerance', 'reduced fussiness, gas, and crying and higher formed stools']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0452742', 'cui_str': 'Formula milk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853245', 'cui_str': 'Soy-based formula'}]","[{'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",72.0,0.0955513,Results indicated that all SF-fed groups contributed to reduction ( P  < .05) in common GI tolerance symptoms to levels not different from the non-symptomatic reference cohort at study end.,"[{'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Lasekan', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Geraldine E', 'Initials': 'GE', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition, Columbus, OH, USA.'}]",Clinical pediatrics,['10.1177/0009922820973017']
2537,33215554,Rates and Predictors of Deterioration in a Trial of Internet-Delivered Cognitive Behavioral Therapy for Reducing Suicidal Thoughts.,"OBJECTIVE


It is necessary for suicide prevention interventions to demonstrate safety. One important aspect of safety is evidence that deterioration rates are low. No studies have examined deterioration of suicidal ideation in the context of an internet-based cognitive behavioral therapy (CBT) intervention to reduce suicidal ideation. A secondary analysis of the outcomes of an online trial was conducted to determine rates of deterioration in a CBT intervention called Living with Deadly Thoughts, relative to an attention control condition, and to identify factors associated with deterioration.
METHOD


The randomized controlled trial included 418 adults with suicidal ideation at baseline (77% females, mean age 40.6 years). Deterioration was defined in two ways: a reliable increase in Suicidal Ideation Attributes Scale (SIDAS score) of ≥6.0 units; or triggering the safety protocol during the trial as determined by high levels of suicidality. Analyses were repeated with multiply imputed data. Predictors of deterioration were identified using logistic regression analysis.
RESULTS


30 (14%) participants in the control group and 15 (7%) in the intervention group met criteria for reliable deterioration (Fisher's exact  p  = 0.027). In a fully adjusted logistic regression model, greater initial severity of suicidal thinking was associated with lower odds of deterioration, while intervention condition, demographics, psychological factors and mental health factors had no significant association with deterioration.
CONCLUSIONS


Participation in an online suicide prevention intervention was associated with lower prevalence of reliable deterioration than participation in an attention-control intervention, providing further evidence that internet-based CBT interventions do not cause harm. Highlights First study to assess deterioration in an internet suicide prevention intervention Rates of reliable deterioration were higher in control (14%) than intervention (7%) No psychological or demographic factors were robustly associated with deterioration Findings provide further evidence that internet based CBT programs are not harmful.",2020,No psychological or demographic factors were robustly associated with deterioration Findings provide further evidence that internet based CBT programs are not harmful.,"['418 adults with suicidal ideation at baseline (77% females, mean age 40.6\u2009years']","['internet-based cognitive behavioral therapy (CBT) intervention', 'Internet-Delivered Cognitive Behavioral Therapy']","['suicidal ideation', 'Deterioration', 'Suicidal Ideation Attributes Scale (SIDAS score', 'Suicidal Thoughts', 'initial severity of suicidal thinking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1050646', 'cui_str': 'Fanpetals'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}]",418.0,0.0345996,No psychological or demographic factors were robustly associated with deterioration Findings provide further evidence that internet based CBT programs are not harmful.,"[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': ''}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': ''}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Kazan', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1848671']
2538,33215652,Comparison between two screws for maxillary expansion: a multicenter randomized controlled trial on patient's reported outcome measures.,"OBJECTIVE


The objective of this study was to compare an expansion screw of the maxilla that generates moderate and continuous forces versus a conventional screw for rapid maxillary expansion (RME) on patient-reported outcome measure during the first 12 weeks of treatment.
TRIAL DESIGN


This is a superiority, multicenter, two-arm parallel balanced randomization trial.
METHODS


Patients in the mixed dentition were included with a transverse discrepancy between the two arches of at least 3 mm. An expansion screw using moderate continuous forces (Leaf group, treated with an expansion screw with Ni-Ti springs) was compared to a conventional RME screw that generates intermittent heavy forces (RME group). The primary response variable was the visual analogue scale (VAS) on pain calculated in the first 12 weeks of therapy. The VAS on difficulty on speaking and oral hygiene, patient satisfaction, and complications were also evaluated. A computer-generated block randomization was used with allocation concealed in sequentially numbered opaque-sealed envelopes. Blinding was not applicable. Linear models were used for statistical analysis.
RESULTS


Twenty-eight patients in the Leaf group and 28 patients in the RME group were randomized and included in the study. There were no dropouts. The mean of the VAS for pain was 0.3 ± 0.4 in the Leaf group and 0.6 ± 0.5 in the RME group. The difference was -0.3 (95 per cent CI from -0.5 to -0.0; P = 0.017) in favour of the Leaf group. The difference in pain was marked in the first week (Leaf group 2.2 ± 2.3; RME group 3.7 ± 2.6; difference -1.5; 95 per cent CI from -2.7 to -0.3; P = 0.019).
CONCLUSIONS


Patients in the Leaf group experienced a lower degree of pain, especially during the first week following the application of the expander. For the other variables, no significant differences were reported between the two treatments.
REGISTRATION


The study was registered in the ISRCTN register on 8 November 2016 with the number ISRCTN18263886.",2020,"The difference in pain was marked in the first week (Leaf group 2.2 ± 2.3; RME group 3.7 ± 2.6; difference -1.5; 95 per cent CI from -2.7 to -0.3; P = 0.019).
","['Twenty-eight patients in the Leaf group and 28 patients in the RME group', 'Patients in the mixed dentition were included with a transverse discrepancy between the two arches of at least 3 mm']","['VAS', 'expansion screw with Ni-Ti springs', 'conventional RME screw', 'conventional screw for rapid maxillary expansion (RME']","['degree of pain', 'speaking and oral hygiene, patient satisfaction, and complications', 'mean of the VAS for pain', 'visual analogue scale (VAS) on pain calculated', 'pain']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}, {'cui': 'C0011444', 'cui_str': 'Mixed dentition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0076736', 'cui_str': 'Nickel titanium'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.0896258,"The difference in pain was marked in the first week (Leaf group 2.2 ± 2.3; RME group 3.7 ± 2.6; difference -1.5; 95 per cent CI from -2.7 to -0.3; P = 0.019).
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, The University of Florence, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Paoloni', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Lione', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Barone', 'Affiliation': 'Private Practice, Florence, Italy.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Marino Merlo', 'Affiliation': 'Scuola di Specializzazione in Ortognatodonzia, The University of Florence, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Giuntini', 'Affiliation': 'Department of Orthodontics and Pediatric Dentistry, School of Dentistry, The University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cozza', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Franchi', 'Affiliation': 'Department of Experimental and Clinical Medicine, The University of Florence, Italy.'}]",European journal of orthodontics,['10.1093/ejo/cjaa063']
2539,33215768,Prophylactic dressings in the prevention of pressure ulcer related to the use of personal protective equipment by health professionals facing the Covid-19 pandemic: a randomized clinical trial.,"Device-Related Pressure Injury (DRPI) is a serious problem that is affecting professionals working on the front lines against COVID-19 due to the prolonged use of Personal Protective Equipment (PPE). In addition to the physical and psychological integrity of professionals, these injuries can compromise the quality of care. Therefore, using technologies to prevent this adverse effect is an urgent matter. This is a parallel two-arm randomized clinical trial without the use of a control group to compare the use of foam and extra-thin hydrocolloid in preventing DRPI associated with the use of PPE by health professionals working on the front lines against coronavirus. In total, 88 professionals were divided into two groups: foam and hydrocolloid. Data were collected using two instruments and related to demographic and professional characteristics and skin evaluation. Each volunteer received one of the dressings, both with the same dimensions and arranged over similar regions, and data were gathered at baseline and after 6 or 12 hours. Descriptive and inferential analytic statistical methods were used; the significance level adopted was 5%. No participant developed DRPI, but four areas with hyperemia were observed in the foam group (2 in the forehead, 1 in the cheeks, and 1 in the nose bridge), as well as four areas with hyperemia in the hydrocolloid group (2 in the nose bridge, 1 in the right ear, and 1 in the left ear). There was no difference between the groups regarding skin conditions and discomfort (p > .05). The average cost obtained was $ 5.8/person and $ 4.4/person in the foam group and the hydrocolloid group, respectively, considering the dressing measurements. The results show that foam and extra-thin hydrocolloid were effective in preventing DRPI associated with the use of PPE. This article is protected by copyright. All rights reserved.",2020,There was no difference between the groups regarding skin conditions and discomfort (p > .05).,['88 professionals'],"['Prophylactic dressings', 'Device-Related Pressure Injury (DRPI', 'foam and hydrocolloid', 'foam and extra-thin hydrocolloid']","['DRPI', 'skin conditions and discomfort', 'average cost obtained']",[],"[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0020266', 'cui_str': 'Hydrocolloid'}, {'cui': 'C0205168', 'cui_str': 'Thin'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]",88.0,0.026898,There was no difference between the groups regarding skin conditions and discomfort (p > .05).,"[{'ForeName': 'Renata Cristina', 'Initials': 'RC', 'LastName': 'Gasparino', 'Affiliation': 'University of Campinas, School of Nursing, Campinas, SP, Brazil.'}, {'ForeName': 'Maria Helena Melo', 'Initials': 'MHM', 'LastName': 'Lima', 'Affiliation': 'University of Campinas, School of Nursing, Campinas, SP, Brazil.'}, {'ForeName': 'Ana Railka de Souza', 'Initials': 'ARS', 'LastName': 'Oliveira-Kumakura', 'Affiliation': 'University of Campinas, School of Nursing, Campinas, SP, Brazil.'}, {'ForeName': 'Vanessa Abreu', 'Initials': 'VA', 'LastName': 'da Silva', 'Affiliation': 'Clinical Hospital, University of Campinas - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Mariana de Jesus', 'Initials': 'MJ', 'LastName': 'Meszaros', 'Affiliation': 'Clinical Hospital, University of Campinas - Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ivan Rogério', 'Initials': 'IR', 'LastName': 'Antunes', 'Affiliation': 'Clinical Hospital, University of Campinas - Campinas, São Paulo, Brazil.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12877']
2540,33215818,Authors' reply re: Caesarean section in the second delivery to prevent anal incontinence after asymptomatic obstetrical anal sphincter injury: the EPIC multicentre randomised trial.,,2020,,['asymptomatic obstetrical anal sphincter injury'],[],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}]",[],[],,0.110485,,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Abramowitz', 'Affiliation': 'Department of Gastroenterology, Hopital Bichat, Proctology Unit, APHP, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mandelbrot', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hopital Louis-Mourier, APHP, Colombes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tubach', 'Affiliation': ""Departement de Sante Publique, INSERM, Institut Pierre Louis d'Epidemiologie et de Sante Publique, AP-HP, Hopital Pitie-Salpetriere, Sorbonne Universite, Paris, France.""}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Roy', 'Affiliation': 'Unite de Recherche Clinique, Hopital Bichat, APHP, Paris, France.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16576']
2541,33215820,Re: Cesarean section in the second delivery to prevent anal incontinence after asymptomatic obstetrical anal sphincter injury: the EPIC multicentre randomised trial.,,2020,,['anal incontinence after asymptomatic obstetrical anal sphincter injury'],['Re: Cesarean section'],[],"[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",[],,0.127601,,"[{'ForeName': 'Nicola Adanna', 'Initials': 'NA', 'LastName': 'Okeahialam', 'Affiliation': 'Thornton Heath, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Ka Woon', 'Initials': 'KW', 'LastName': 'Wong', 'Affiliation': 'Thornton Heath, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Roper', 'Affiliation': 'Thornton Heath, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Thornton Heath, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Abdul H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': 'Thornton Heath, Croydon University Hospital, Croydon, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16578']
2542,33215879,Biomechanical Comparison of INTERTAN Nail and Gamma3 Nail for Intertrochanteric Fractures.,"OBJECTIVE


To compare the biomechanical stabilities of Gamma3 nail and INTERTAN nail (ITN) for stable (AO/OTA 31A1.1) and unstable (AO/OTA 31A2.2) femoral intertrochanteric fracture.
METHODS


Twenty-four synthetic femora were randomly divided into four groups. After internal fixation (Gamma3 nail or ITN) had been implanted, stable and unstable intertrochanteric fracture models were produced. A cyclic testing protocol with increasing loads was performed for both stable and unstable intertrochanteric fracture models, and then torsional test and axial compression failure test were conducted. Stiffness, failure load, torque, and fragment displacement were recorded.
RESULTS


For stable fracture model: fragment displacement in ITN group were smaller than Gamma3 nail group (Gamma3 nail: 1.66 ± 0.13 mm; ITN: 1.55 ± 0.1 mm); stiffness (Gamma3 nail: 1142.6 ± 161.1 N/mm, ITN: 1159.3 ± 203.5 N/mm, P = 0.872) and failure load (Gamma3 nail: 5715.42 ± 616.34 N, ITN: 5690.27 ± 625.59 N, P = 0. 951) of the two nails were similar after cyclic test; torque of the ITN group was larger than the Gamma3 nail group. For unstable fracture model: fragment displacement in ITN group was significantly smaller than in the Gamma3 nail group when the axial load was larger than 800 N (Gamma3 nail: 3.59 ± 0.19 mm; ITN: 2.93 ± 0.28 mm); ITN group showed a significantly higher failure load than Gamma3 nail group (Gamma3 nail: 2942.77 ± 573.4 N, ITN: 3672.3 ± 790.5 N, P = 0. 011); torque was significantly higher for the ITN group compared to the Gamma3 nail group for three different angles.
CONCLUSIONS


Both ITN and Gamma3 nail can maintain sufficient biomechanical stability for stable intertrochanteric fractures, but ITN was a better choice for unstable intertrochanteric fractures.",2020,"For unstable fracture model: fragment displacement in ITN group was significantly smaller than in the Gamma3 nail group when the axial load was larger than 800 N (Gamma3 nail: 3.59 ± 0.19 mm; ITN: 2.93 ± 0.28 mm); ITN group showed a significantly higher failure load than Gamma3 nail group (Gamma3 nail: 2942.77 ± 573.4 N, ITN: 3672.3 ± 790.5 N, P = 0. 011); torque was significantly higher for the ITN group compared to the Gamma3 nail group for three different angles.
","['Intertrochanteric Fractures', 'Twenty-four synthetic femora']","['internal fixation (Gamma3 nail or ITN', 'Gamma3 nail and INTERTAN nail (ITN', 'Nail and Gamma3 Nail', 'ITN and Gamma3 nail']","['failure load', 'Stiffness, failure load, torque, and fragment displacement']","[{'cui': 'C0162385', 'cui_str': 'Intertrochanteric fracture'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",,0.0143201,"For unstable fracture model: fragment displacement in ITN group was significantly smaller than in the Gamma3 nail group when the axial load was larger than 800 N (Gamma3 nail: 3.59 ± 0.19 mm; ITN: 2.93 ± 0.28 mm); ITN group showed a significantly higher failure load than Gamma3 nail group (Gamma3 nail: 2942.77 ± 573.4 N, ITN: 3672.3 ± 790.5 N, P = 0. 011); torque was significantly higher for the ITN group compared to the Gamma3 nail group for three different angles.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Orthopeadics Clinical College, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Orthopeadics Clinical College, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jian-Xiong', 'Initials': 'JX', 'LastName': 'Ma', 'Affiliation': 'Orthopeadics Institute, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'Jing-Min', 'Initials': 'JM', 'LastName': 'Huang', 'Affiliation': 'Department of Arthroscopy, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Arthroscopy, Tianjin Hospital, Tianjin, China.'}, {'ForeName': 'Xin-Long', 'Initials': 'XL', 'LastName': 'Ma', 'Affiliation': 'Orthopeadics Clinical College, Tianjin Medical University, Tianjin, China.'}]",Orthopaedic surgery,['10.1111/os.12853']
2543,33215889,Treating Posttraumatic Stress Disorder Symptoms With Low Amplitude Seizure Therapy (LAP-ST) Compared With Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial.,"OBJECTIVES


An important barrier to further studying electroconvulsive therapy (ECT) in posttraumatic stress disorder (PTSD) is the cognitive adverse effects. However, recent data suggest that low amplitude seizure therapy (LAP-ST) has no or minimal cognitive adverse effects. The aims of this report were to examine the efficacy of LAP-ST in PTSD and to compare LAP-ST with standard right unilateral (RUL) ECT using a pilot randomized clinical trial.
METHODS


Patients were randomized to LAP-ST or RUL ECT. Posttraumatic stress disorder was assessed using clinical interview based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and symptom severity with PTSD Checklist (PCL). The scores pertaining to PCL were analyzed using descriptive analysis for this pilot study.
RESULTS


Eleven patients consented to be enrolled. Seven were randomly allocated to LAP-ST or RUL ECT. Five completed the study and had completed PCL before and after the course. In both groups, PTSD symptoms showed fast improvement. The effect size of improvement seems promising. The mean baseline PCL score for patients in the LAP-ST group was 42.5 (SD = 16.26) and the mean end point PCL score after treatment was 31 (SD = 15.56). The mean baseline PCL score for patients in the standard RUL ECT group was 64.7 (SD = 1.15) and the mean end point was 41 (SD = 15.62).
CONCLUSIONS


Both LAP-ST and standard RUL ECT showed reduction in PTSD symptoms with fast improvement. This first PTSD LAP-ST study adds support to the prior LAP-ST proof-of-concept clinical trial that LAP-ST can produce effective therapeutic outcomes. Replication of this trial is warranted in larger clinical trials (ClinicalTrials.gov ID: NCT02583490).",2020,"The mean baseline PCL score for patients in the standard RUL ECT group was 64.7 (SD = 1.15) and the mean end point was 41 (SD = 15.62).
","['posttraumatic stress disorder (PTSD', 'Patients', 'Eleven patients consented to be enrolled']","['Standard Right Unilateral Electroconvulsive Therapy', 'LAP-ST with standard right unilateral (RUL) ECT', 'LAP-ST and standard RUL ECT', 'electroconvulsive therapy (ECT', 'standard RUL ECT', 'low amplitude seizure therapy (LAP-ST', 'Low Amplitude Seizure Therapy (LAP-ST', 'LAP-ST or RUL ECT', 'LAP-ST']","['mean baseline PCL score', 'PTSD symptoms', 'mean end point PCL score', 'Posttraumatic stress disorder', 'Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and symptom severity with PTSD Checklist (PCL']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",11.0,0.0705082,"The mean baseline PCL score for patients in the standard RUL ECT group was 64.7 (SD = 1.15) and the mean end point was 41 (SD = 15.62).
","[{'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'From the Department of *Psychiatry and Health Behavior †Office of Academic Affairs, Medical College of Georgia at Augusta University ‡Charlie Norwood VA Medical Center, Augusta, GA.'}, {'ForeName': 'Sadiya', 'Initials': 'S', 'LastName': 'Dhanani', 'Affiliation': ''}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': ''}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': ''}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000701']
2544,33215948,The Mirror Effect Plus Protocol for acute Bell's palsy: a randomised and longitudinal study on facial rehabilitation.,"BACKGROUND


Small but interesting evidences suggest that facial rehabilitation for acute Bell Palsy (BP) could improve facial outcomes in patients who benefited from optimal medication, but whose symptoms are still severe two weeks after BP's onset.
AIMS


This study aimed to provide preliminary evidence of the long-term effects of a new facial retraining based on motor imagery and mirror therapy, the Mirror Effect Plus Protocol (MEPP).
MATERIAL AND METHODS


Twenty BP patients received the standard medication for acute BP and were then randomly allocated to the treatment (MEPP) or control group, if their palsy was still at least moderate-to-severe at 14 days post onset. Three blind independent assessors graded the patients' evolution until 6 months after onset.
RESULTS


Significant differences between the groups were not found for any measured variable; however, a trend toward better recovery was found in the treatment group for every measured variable. This trend grew bigger for patients with severe or total BP.
CONCLUSIONS


This study suggests a promising effect of the MEPP on acute severe to total BP but requires further investigation with a larger number of participants.
SIGNIFICANCE


Facial rehabilitation should be considered as an adjunct to medication for acute and most severe degrees of BP.",2020,"RESULTS


Significant differences between the groups were not found for any measured variable; however, a trend toward better recovery was found in the treatment group for every measured variable.","[""acute Bell's palsy"", 'Twenty BP patients received the standard medication for acute BP', 'patients with severe or total BP', ""patients who benefited from optimal medication, but whose symptoms are still severe two weeks after BP's onset""]","['facial rehabilitation', 'MEPP', 'new facial retraining based on motor imagery and mirror therapy, the Mirror Effect Plus Protocol (MEPP']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015469', 'cui_str': 'Facial palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],20.0,0.169619,"RESULTS


Significant differences between the groups were not found for any measured variable; however, a trend toward better recovery was found in the treatment group for every measured variable.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Martineau', 'Affiliation': 'Hôpital Maisonneuve-Rosemont, Montréal, QC, Canada.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Rahal', 'Affiliation': 'Hôpital Maisonneuve-Rosemont, Montréal, QC, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Piette', 'Affiliation': ""Centre de recherche du Centre intégré universitaire de santé et services sociaux du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Chouinard', 'Affiliation': ""Centre de recherche du Centre intégré universitaire de santé et services sociaux du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Marcotte', 'Affiliation': ""Centre de recherche du Centre intégré universitaire de santé et services sociaux du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, Montréal, QC, Canada.""}]",Acta oto-laryngologica,['10.1080/00016489.2020.1842905']
2545,33215986,"Risk-based, 6-monthly and 24-monthly dental check-ups for adults: the INTERVAL three-arm RCT.","BACKGROUND


Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health.
OBJECTIVES


To test effectiveness and assess the cost-benefit of different dental recall intervals over a 4-year period.
DESIGN


Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost-benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval.
SETTING


UK primary care dental practices.
PARTICIPANTS


Adult, dentate, NHS patients who had visited their dentist in the previous 2 years.
INTERVENTIONS


Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall.
MAIN OUTCOMES


Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit.
RESULTS


A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month ( n  = 138) versus 6-month group ( n  = 135) had an adjusted mean difference of -0.91 (95% confidence interval -5.02 to 3.20); the risk-based ( n  = 143) versus 6-month group had an adjusted mean difference of -0.98 (95% confidence interval -5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval -3.99 to 4.12). For the overall sample, the risk-based ( n  = 749) versus 6-month ( n  = 737) adjusted mean difference was 0.78 (95% confidence interval -1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup.
LIMITATIONS


Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected.
CONCLUSIONS


Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider.
FUTURE WORK


Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN95933794.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full in  Health Technology Assessment ; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.",2020,There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison.,"['Participants ineligible for 24-month recall', 'Adult, dentate, NHS patients who had visited their dentist in the previous 2 years', '2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible', 'UK primary care dental practices']",[],"['oral health', 'oral health-related quality of life', 'Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit', 'mean percentage of sites with gingival bleeding']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376349', 'cui_str': 'Bleeding on probing of gingivae'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}]",2372.0,0.212193,There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison.,"[{'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Nigel B', 'Initials': 'NB', 'LastName': 'Pitts', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Dwayne', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Floate', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Hazel J', 'Initials': 'HJ', 'LastName': 'Braid', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Fee', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Ord', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Helen V', 'Initials': 'HV', 'LastName': 'Worthington', 'Affiliation': 'School of Dentistry, University of Manchester, Manchester, UK.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'van der Pol', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'Dental Directorate, NHS Education for Scotland, Edinburgh, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gouick', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Gerald M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Mitchell', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John Dt', 'Initials': 'JD', 'LastName': 'Norrie', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Sim', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Douglas', 'Affiliation': 'School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ricketts', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24600']
2546,33216002,Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study.,"BACKGROUND


Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT.
OBJECTIVE


Nested within a randomized controlled trial of telephone- and web-delivered CBT for refractory IBS, this qualitative study aims to identify barriers to and facilitators of engagement over time with the interventions, identify social and psychological processes of change, and provide insight into trial results.
METHODS


A longitudinal qualitative study was nested in a randomized controlled trial. Repeated semistructured interviews were conducted at 3 (n=34) and 12 months (n=25) post baseline. Participants received telephone-based CBT (TCBT; n=17 at 3 months and n=13 at 12 months) or web-based CBT (WCBT; n=17 at 3 months and n=12 at 12 months). Inductive thematic analysis was used to analyze the data.
RESULTS


Participants viewed CBT as credible for IBS, perceived their therapists as knowledgeable and supportive, and liked the flexibility of web-based and telephone-based delivery; these factors facilitated engagement. Potential barriers to engagement in both groups (mostly overcome by our participants) included initial skepticism and concerns about the biopsychosocial nature of CBT, initial concerns about telephone-delivered talking therapy, challenges of maintaining motivation and self-discipline given already busy lives, and finding nothing new in the WCBT (WCBT group only). Participants described helpful changes in their understanding of IBS, attitudes toward IBS, ability to recognize IBS patterns, and IBS-related behaviors. Consistent with the trial results, participants described lasting positive effects on their symptoms, work, and social lives. Reasons and remedies for some attenuation of effects were identified.
CONCLUSIONS


Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life. These forms of CBT may broaden access to CBT for IBS.",2020,"Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life.",['people with refractory irritable bowel syndrome (IBS'],"['telephone', 'Telephone-Based and Web-Based Cognitive Behavioral Therapy', 'web-based CBT (WCBT', 'Cognitive behavioral therapy (CBT', 'TCBT and WCBT', 'telephone-based CBT (TCBT']","['IBS, IBS-related behaviors, symptoms, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0531511,"Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Hazel A', 'Initials': 'HA', 'LastName': 'Everitt', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'J Matthew', 'Initials': 'JM', 'LastName': 'Harvey', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vas Falcao', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Gilly', 'Initials': 'G', 'LastName': ""O'Reilly"", 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sula', 'Initials': 'S', 'LastName': 'Windgassen', 'Affiliation': ""Academic Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Coleman', 'Affiliation': 'Department of Gastroenterology, Southampton University Hospital, Southampton, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Logan', 'Affiliation': 'Kings College Hospital, London, United Kingdom.'}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Bishop', 'Affiliation': 'Centre for Clinical and Community Applications of Health Psychology, Department of Psychology, University of Southampton, Southampton, United Kingdom.'}]",Journal of medical Internet research,['10.2196/18691']
2547,33216004,Implementing Mobile Health-Enabled Integrated Care for Complex Chronic Patients: Patients and Professionals' Acceptability Study.,"BACKGROUND


Integrated care (IC) can promote health and social care efficiency through prioritization of preventive patient-centered models and defragmentation of care and collaboration across health tiers, and mobile health (mHealth) can be the cornerstone allowing for the adoption of IC.
OBJECTIVE


This study aims to assess the acceptability, usability, and satisfaction of an mHealth-enabled IC model for complex chronic patients in both patients and health professionals.
METHODS


As part of the CONNECARE Horizon 2020 project, a prospective, pragmatic, 2-arm, parallel, hybrid effectiveness-implementation trial was conducted from July 2018 to August 2019 in a rural region of Catalonia, Spain. Home-dwelling patients 55 years and older with chronic conditions and a history of hospitalizations for chronic obstructive pulmonary disease or heart failure (use case [UC] 1), or a scheduled major elective hip or knee arthroplasty (UC2) were recruited. During the 3 months, patients experienced an mHealth-enabled IC model, including a self-management app for patients, a set of integrated sensors, and a web-based platform connecting professionals from different settings or usual care. The Person-Centered Coordinated Care Experience Questionnaire (P3CEQ) and the Nijmegen Continuity Questionnaire (NCQ) assessed person-centeredness and continuity of care. Acceptability was assessed for IC arm patients and staff with the Net Promoter Score (NPS) and the System Usability Scale (SUS).
RESULTS


The analyses included 77 IC patients, 58 controls who completed the follow-up, and 30 health care professionals. The mean age was 78 (SD 9) years in both study arms. Perception of patient-centeredness was similarly high in both arms (usual care: mean P3CEQ score 16.1, SD 3.3; IC: mean P3CEQ score 16.3, SD 2.4). IC patients reported better continuity of care than controls (usual care: mean NCQ score 3.7, SD 0.9; IC: mean NCQ score 4.0, SD 1; P=.04). The scores for patient acceptability (UC1: NPS +67%; UC2: NPS +45%) and usability (UC1: mean SUS score 79, SD 14; UC2: mean SUS score 68, SD 24) were outstanding. Professionals' acceptability was low (UC1: NPS -25%; UC2: NPS -35%), whereas usability was average (UC1: mean SUS score 63, SD 20; UC2: mean SUS score 62, SD 19). The actual use of technology was high; 77% (58/75) of patients reported physical activity for at least 60 days, and the ratio of times reported over times prescribed for other sensors ranged from 37% for oxygen saturation to 67% for weight.
CONCLUSIONS


The mHealth-enabled IC model showed outstanding results from the patients' perspective in 2 different UCs but lacked maturity and integration with legacy systems to be fully accepted by professionals. This paper provides useful lessons learned through the development and assessment process and may be of use to organizations willing to develop or implement mHealth-enabled IC for older adults.",2020,"IC patients reported better continuity of care than controls (usual care: mean NCQ score 3.7, SD 0.9; IC: mean NCQ score 4.0, SD 1; P=.04).","['The mean age was 78 (SD 9) years in both study arms', 'July 2018 to August 2019 in a rural region of Catalonia, Spain', 'complex chronic patients in both patients and health professionals', 'Home-dwelling patients 55 years and older with chronic conditions and a history of hospitalizations for chronic obstructive pulmonary disease or heart failure (use case [UC', '77 IC patients, 58 controls who completed the follow-up, and 30 health care professionals']","['scheduled major elective hip or knee arthroplasty (UC2', 'Implementing Mobile Health-Enabled Integrated Care']","['acceptability, usability, and satisfaction', 'Person-Centered Coordinated Care Experience Questionnaire (P3CEQ) and the Nijmegen Continuity Questionnaire (NCQ) assessed person-centeredness and continuity of care', 'Acceptability', ""Professionals' acceptability"", 'physical activity', 'continuity of care', 'Net Promoter Score (NPS) and the System Usability Scale (SUS']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",77.0,0.0457945,"IC patients reported better continuity of care than controls (usual care: mean NCQ score 3.7, SD 0.9; IC: mean NCQ score 4.0, SD 1; P=.04).","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'de Batlle', 'Affiliation': 'Group of Translational Research in Respiratory Medicine, Institut de Recerca Biomedica de Lleida, Lleida, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Massip', 'Affiliation': 'Group of Translational Research in Respiratory Medicine, Institut de Recerca Biomedica de Lleida, Lleida, Spain.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Vargiu', 'Affiliation': 'eHealth Unit, Eurecat, Centre Tecnòlogic de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Nadal', 'Affiliation': 'Gerència Territorial de Barcelona, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Fuentes', 'Affiliation': 'Atenció Primària Àmbit Lleida, Lleida, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ortega Bravo', 'Affiliation': ""Research Support Unit Lleida, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Lleida, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Colomina', 'Affiliation': 'Servei de Cirurgia Ortopèdica i Traumatologia, Hospital de Santa Maria de Lleida, Lleida, Spain.'}, {'ForeName': 'Reis', 'Initials': 'R', 'LastName': 'Drudis', 'Affiliation': 'Unitat de Dolor Agut, Hospital de Santa Maria de Lleida, Lleida, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Torra', 'Affiliation': 'Unitat de Dolor Agut, Hospital de Santa Maria de Lleida, Lleida, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Pallisó', 'Affiliation': 'Servei de Cirurgia Ortopèdica i Traumatologia, Hospital de Santa Maria de Lleida, Lleida, Spain.'}, {'ForeName': 'Felip', 'Initials': 'F', 'LastName': 'Miralles', 'Affiliation': 'eHealth Unit, Eurecat, Centre Tecnòlogic de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'Group of Translational Research in Respiratory Medicine, Institut de Recerca Biomedica de Lleida, Lleida, Spain.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Torres', 'Affiliation': 'Group of Translational Research in Respiratory Medicine, Institut de Recerca Biomedica de Lleida, Lleida, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Institut de Recerca Biomedica de Lleida, Lleida, Spain.'}]",JMIR mHealth and uHealth,['10.2196/22136']
2548,33216008,Engagement With a Web-Based Intervention to Reduce Harmful Drinking: Secondary Analysis of a Randomized Controlled Trial.,"BACKGROUND


Engagement with digital behavior change interventions (DBCIs) is considered a prerequisite for intervention efficacy. However, in many trials on DBCIs, participants use the intervention either only little or not at all.
OBJECTIVE


To analyze engagement with a web-based intervention to reduce harmful drinking, we explored (1) whether engagement with a web-based alcohol intervention is related to drinking outcomes, (2) which user characteristics are associated with measures of engagement, and (3) whether reported outcomes are associated with data captured by voluntary intervention questionnaires.
METHODS


We analyzed data of the intervention arm of a randomized controlled trial on a DBCI to reduce risky alcohol consumption. Data were collected at baseline (T0), after 90 days (T1), and at the end of the 180-day usage period (T2). Engagement with the intervention was measured via system usage data as well as self-reported usage. Drinking behavior was measured as average daily alcohol consumption as well as the number of binge drinking days. User characteristics included demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy. Following a bivariate approach, we performed two-tailed Welch's t tests and Wilcoxon signed rank/Mann-Whitney U tests or calculated correlation coefficients.
RESULTS


The data of 306 users were analyzed. Time spent engaging with the intervention as measured by system usage did not match self-reported usage. Higher self-reported usage was associated with higher reductions in average daily alcohol consumption (T1: ρ=0.39, P<.001; T2: ρ=0.29, P=.015) and in binge drinking days (T1: ρ=0.62, P<.001; T2: ρ=0.3, P=.006). Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1: P=.001; T2: P=.004). Relationships between self-reported usage and clinical or psychological baseline characteristics were complex. For system usage, the findings were mixed. Reductions in drinking captured by intervention questionnaires were associated with reported outcomes.
CONCLUSIONS


Though self-reported usage could be consistently linked to better outcomes and multiple user characteristics, our findings add to the overall inconclusive evidence that can be found throughout the literature. Our findings indicate potential benefits of self-reports as measures of engagement and intervention questionnaires as a basis for tailoring of intervention content. Future studies should adopt a theory-driven approach to engagement research utilizing psychometrically sound self-report questionnaires and include short ecological momentary assessments within the DBCIs.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00006104; https://tinyurl.com/y22oc5jo.",2020,"Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1:","['users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1', '306 users were analyzed']","['Web-Based Intervention', 'digital behavior change interventions (DBCIs', 'DBCI']","['Drinking behavior', 'risky alcohol consumption', 'average daily alcohol consumption', 'demographics, baseline drinking behavior, readiness to change, alcohol-related outcome expectancies, and alcohol abstinence self-efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013124', 'cui_str': 'Drinking Behavior'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",306.0,0.0818516,"Higher usage was reported from users who were single (T1: P<.001; T2: P<.001), users without children (T1: P<.001; T2: P<.001), users who did not start or finish secondary education (T1: P<.001; T2: P<.001), users without academic education (T1: P<.001; T2: P<.001), and those who worked (T1:","[{'ForeName': 'Paul U', 'Initials': 'PU', 'LastName': 'Nordholt', 'Affiliation': 'Department of Nursing and Management, Faculty of Business and Social Sciences, Hamburg University of Applied Sciences, Hamburg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Christalle', 'Affiliation': 'Institute and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jördis M', 'Initials': 'JM', 'LastName': 'Zill', 'Affiliation': 'Institute and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Institute and Outpatient Clinic of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of medical Internet research,['10.2196/18826']
2549,33216113,Safety and Anti-viral Effects of Nebulized PC786 in a Respiratory Syncytial Virus Challenge Study.,"BACKGROUND


PC786 is a nebulized non-nucleoside RSV polymerase inhibitor designed to treat RSV which replicates in the superficial layer of epithelial cells lining the airways.
METHODS


56 healthy volunteers inoculated with RSV-A (Memphis 37b) were randomly dosed with either nebulized PC786 (5mg) or placebo, twice daily for 5 days, from either 12 hours after confirmation of RSV infection or 6 days after virus inoculation. Viral load (VL), disease severity, pharmacokinetics and safety were assessed until discharge. RSV infection was confirmed by RT-qPCR with any positive value (ITT-I population) or RSV RNA ≥1 log10PFUe/mL (ITT-IS population) in nasal wash samples.
RESULTS


In the ITT-I population, the mean VL-AUC was lower in the PC786 group than the placebo group (274.1 vs. 406.6 log10PFUe/mL*h, p=0.0359). PC786 showed a trend towards reduction of symptom score and mucous weight. In ITT-IS (post-hoc analysis), the latter was statistically significant as well as VL-AUC (p=0.0126). PC786 showed an early Tmax, limited systemic exposure, long half-life and consequently a 2-fold accumulation over the 5-day dosing period. PC786 was well tolerated.
CONCLUSIONS


Nebulized PC786 demonstrated a significant anti-viral effect against RSV, warranting further clinical study.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: NCT03382431; EudraCT number: 2017-002563-18.",2020,"PC786 showed an early Tmax, limited systemic exposure, long half-life and consequently a 2-fold accumulation over the 5-day dosing period.",['56 healthy volunteers inoculated with RSV-A (Memphis 37b'],"['nebulized PC786', 'Nebulized PC786', 'PC786', 'placebo']","['mean VL-AUC', 'early Tmax, limited systemic exposure, long half-life', 'RSV infection', 'tolerated', 'Viral load (VL), disease severity, pharmacokinetics and safety', 'symptom score and mucous weight']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}]","[{'cui': 'C4705549', 'cui_str': 'PC786'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0035235', 'cui_str': 'Respiratory syncytial virus infection'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026727', 'cui_str': 'Mucus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",56.0,0.222028,"PC786 showed an early Tmax, limited systemic exposure, long half-life and consequently a 2-fold accumulation over the 5-day dosing period.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeVincenzo', 'Affiliation': 'Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, United States.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Cass', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Murray', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Woodward', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Meals', 'Affiliation': 'Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Coates', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Daly', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Wheeler', 'Affiliation': 'hVIVO Services Ltd., London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mori', 'Affiliation': 'hVIVO Services Ltd., London, United Kingdom.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Brindley', 'Affiliation': 'KinetAssist Ltd., Quothquan, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Meabh', 'Initials': 'M', 'LastName': 'McCurdy', 'Affiliation': 'Exploristics, Belfast, United Kingdom.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Murray', 'Affiliation': 'hVIVO Services Ltd., London, United Kingdom.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Strong', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Rapeport', 'Affiliation': 'Pulmocide Ltd, London, United Kingdom.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa716']
2550,33212063,Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study.,"BACKGROUND


Hereditary transthyretin-mediated amyloidosis is a rare, inherited, progressive disease caused by mutations in the transthyretin (TTR) gene. We assessed the safety and efficacy of long-term treatment with patisiran, an RNA interference therapeutic that inhibits TTR production, in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy.
METHODS


This multicentre, open-label extension (OLE) trial enrolled patients at 43 hospitals or clinical centres in 19 countries as of Sept 24, 2018. Patients were eligible if they had completed the phase 3 APOLLO or phase 2 OLE parent studies and tolerated the study drug. Eligible patients from APOLLO (patisiran and placebo groups) and the phase 2 OLE (patisiran group) studies enrolled in this global OLE trial and received patisiran 0·3 mg/kg by intravenous infusion every 3 weeks with plans to continue to do so for up to 5 years. Efficacy assessments included measures of polyneuropathy (modified Neuropathy Impairment Score +7 [mNIS+7]), quality of life, autonomic symptoms, nutritional status, disability, ambulation status, motor function, and cardiac stress, with analysis by study groups (APOLLO-placebo, APOLLO-patisiran, phase 2 OLE patisiran) based on allocation in the parent trial. The global OLE is ongoing with no new enrolment, and current findings are based on the interim analysis of the patients who had completed 12-month efficacy assessments as of the data cutoff. Safety analyses included all patients who received one or more dose of patisiran up to the data cutoff. This study is registered with ClinicalTrials.gov, NCT02510261.
FINDINGS


Between July 13, 2015, and Aug 21, 2017, of 212 eligible patients, 211 were enrolled: 137 patients from the APOLLO-patisiran group, 49 from the APOLLO-placebo group, and 25 from the phase 2 OLE patisiran group. At the data cutoff on Sept 24, 2018, 126 (92%) of 137 patients from the APOLLO-patisiran group, 38 (78%) of 49 from the APOLLO-placebo group, and 25 (100%) of 25 from the phase 2 OLE patisiran group had completed 12-month assessments. At 12 months, improvements in mNIS+7 with patisiran were sustained from parent study baseline with treatment in the global OLE (APOLLO-patisiran mean change -4·0, 95 % CI -7·7 to -0·3; phase 2 OLE patisiran -4·7, -11·9 to 2·4). Mean mNIS+7 score improved from global OLE enrolment in the APOLLO-placebo group (mean change from global OLE enrolment -1·4, 95% CI -6·2 to 3·5). Overall, 204 (97%) of 211 patients reported adverse events, 82 (39%) reported serious adverse events, and there were 23 (11%) deaths. Serious adverse events were more frequent in the APOLLO-placebo group (28 [57%] of 49) than in the APOLLO-patisiran (48 [35%] of 137) or phase 2 OLE patisiran (six [24%] of 25) groups. The most common treatment-related adverse event was mild or moderate infusion-related reactions. The frequency of deaths in the global OLE was higher in the APOLLO-placebo group (13 [27%] of 49), who had a higher disease burden than the APOLLO-patisiran (ten [7%] of 137) and phase 2 OLE patisiran (0 of 25) groups.
INTERPRETATION


In this interim 12-month analysis of the ongoing global OLE study, patisiran appeared to maintain efficacy with an acceptable safety profile in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Continued long-term follow-up will be important for the overall assessment of safety and efficacy with patisiran.
FUNDING


Alnylam Pharmaceuticals.",2020,Serious adverse events were more frequent in the APOLLO-placebo group (28 [57%] of 49) than in the APOLLO-patisiran (48 [35%] of 137) or phase 2 OLE patisiran (six [24%] of 25) groups.,"['hereditary transthyretin-mediated amyloidosis with polyneuropathy', 'patients who received one or more dose of patisiran up to the data cutoff', 'Between July 13, 2015, and Aug 21, 2017, of 212 eligible patients, 211 were enrolled: 137 patients from the APOLLO-patisiran group, 49 from the APOLLO-placebo group, and 25 from the phase 2 OLE patisiran group', 'patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy', 'Patients were eligible if they had completed the phase 3 APOLLO or phase 2 OLE parent studies and tolerated the study drug', 'Eligible patients from APOLLO (patisiran and placebo groups) and the phase 2 OLE (patisiran group) studies enrolled in this global OLE trial and received', 'trial enrolled patients at 43 hospitals or clinical centres in 19 countries as of Sept 24, 2018']","['patisiran 0·3 mg/kg by intravenous infusion', 'placebo', 'patisiran', 'open-label extension (OLE']","['serious adverse events', 'safety and efficacy', 'frequency of deaths in the global OLE', 'measures of polyneuropathy (modified Neuropathy Impairment Score +7 [mNIS+7]), quality of life, autonomic symptoms, nutritional status, disability, ambulation status, motor function, and cardiac stress', 'Mean mNIS+7 score', 'Serious adverse events', 'adverse events']","[{'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C3896714', 'cui_str': 'patisiran'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",212.0,0.088142,Serious adverse events were more frequent in the APOLLO-placebo group (28 [57%] of 49) than in the APOLLO-patisiran (48 [35%] of 137) or phase 2 OLE patisiran (six [24%] of 25) groups.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Adams', 'Affiliation': 'Université Paris-Saclay, U1195, INSERM, Le Kremlin Bicêtre, France; Neurology Department, AP-HP, Centre Hospitalier Universitaire Bicêtre, Le Kremlin Bicêtre, France. Electronic address: david.adams@aphp.fr.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'González-Duarte', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Wixner', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Department of Cardiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hartmut H', 'Initials': 'HH', 'LastName': 'Schmidt', 'Affiliation': 'University of Münster, Münster, Germany.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Inés Asunción', 'Initials': 'IA', 'LastName': 'Losada López', 'Affiliation': 'Balearic Islands Health Research Institute, Palma, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dispenzieri', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'Conceição', 'Affiliation': 'Centro Hospitalar Universitário Lisboa Norte, Hospital de Santa Maria and Faculdade de Medicina, Lisbon, Portugal.'}, {'ForeName': 'Michel S', 'Initials': 'MS', 'LastName': 'Slama', 'Affiliation': 'Cardiology Department, Centre de Compétence Amylose Cardiaque, Centre Hospitalier Universitaire Xavier Bichat Assistance Publique Hôpitaux de Paris, Université Paris-Saclay, Paris, France.'}, {'ForeName': 'Julian D', 'Initials': 'JD', 'LastName': 'Gillmore', 'Affiliation': 'National Amyloidosis Centre, University College London, Royal Free Hospital, London, UK.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Kyriakides', 'Affiliation': 'The Cyprus Institute of Neurology and Genetics, Nicosia, Cyprus; Medical School, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Senda', 'Initials': 'S', 'LastName': 'Ajroud-Driss', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Hospital Universitario Clementino Fraga Filho-Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Mezei', 'Affiliation': 'Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Planté-Bordeneuve', 'Affiliation': 'Centre Hospitalier Universitaire, Henri Mondor-Assistance Publique Hopitaux de Paris, Univ Paris Est Creteil, INSERM, IMRB, Creteil, France.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Attarian', 'Affiliation': 'Neuromuscular disorders and ALS Department, Centre Hospitalier Universitaire La Timone, Marseille, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mauricio', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University, College of Physicians and Surgeons, Neurology Department, New York, NY, USA.'}, {'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Ueda', 'Affiliation': 'Kumamoto University Hospital, Department of Neurology, Kumamoto, Japan.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Aldinc', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'White', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Berber', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA; Myokardia, Brisbane, CA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Centro Hospitalar Universitário do Porto, Porto, Portugal.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30368-9']
2551,33212111,Exercise training improves microvascular function in patients with Chagas heart disease: Data from the PEACH study.,"BACKGROUND


Chagas heart disease (CHD) impairs the systemic microvascular function. We investigated the effects of exercise training on cutaneous microvascular function among patients with CHD.
METHODS


Patients from the PEACH study were randomly assigned to a supervised exercise training 3 times/week for 6 months (Trained; n = 10) or a control group (Untrained; n = 8). Both groups underwent evaluation of microvascular function before, and at 3- and 6-months of follow-up. Cutaneous vascular conductance (CVC) was assessed in the skin of the forearm using laser speckle contrast imaging coupled with iontophoresis of acetylcholine (ACh), sodium nitroprusside (SNP) and during post-occlusive reactive hyperemia (PORH).
RESULTS


At 3-months of follow-up, no difference was detected between groups in CVC responses to ACh (p = 0.50), SNP (p = 0.26) and HRPO (p = 0.65). However, at 6-months of follow-up, trained vs. untrained patients improved CVC induced by SNP-iontophoresis (0.19 ± 0.10 vs. 0.14 ± 0.15 APU.mmHg -1 ; p = 0.05) and PORH (0.63 ± 0.15 vs. 0.48 ± 0.18 APU.mmHg -1 ; p = 0.05). CVC response to ACh-iontophoresis was similar between groups (0.19 ± 0.11 vs. 0.22 ± 0.17 APU.mmHg -1 ; p = 0.38).
CONCLUSION


Exercise training performed during 6 months improved the cutaneous microvascular function of CHD patients. Further studies evaluating the mechanism involved in this response are warranted.",2020,"At 3-months of follow-up, no difference was detected between groups in CVC responses to ACh (p = 0.50), SNP (p = 0.26) and HRPO (p = 0.65).","['patients with Chagas heart disease', 'Patients from the PEACH study', 'patients with CHD']","['exercise training', 'acetylcholine (ACh), sodium nitroprusside (SNP', 'supervised exercise training 3 times/week for 6\u202fmonths (Trained; n\u202f=\u202f10) or a control group (Untrained; n\u202f=\u202f8', 'Exercise training']","['cutaneous microvascular function', 'CVC responses to ACh', 'PORH', 'CVC response to ACh-iontophoresis', 'HRPO', 'Cutaneous vascular conductance (CVC', 'CVC', 'microvascular function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041234', 'cui_str': 'Infection by Trypanosoma cruzi'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0330659', 'cui_str': 'Prunus persica'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",,0.0358511,"At 3-months of follow-up, no difference was detected between groups in CVC responses to ACh (p = 0.50), SNP (p = 0.26) and HRPO (p = 0.65).","[{'ForeName': 'Juliana Pereira', 'Initials': 'JP', 'LastName': 'Borges', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil. Electronic address: julipborges@gmail.com.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'de Souza Nogueira Sardinha Mendes', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Marcus Vinícius', 'Initials': 'MV', 'LastName': 'Dos Santos Rangel', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'de Oliveira Lopes', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Department of Research and Education, National Institute of Cardiology, Ministry of Health, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gilberto Marcelo Sperandio', 'Initials': 'GMS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Paula Simplício', 'Initials': 'PS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Mazzoli-Rocha', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Roberto Magalhães', 'Initials': 'RM', 'LastName': 'Saraiva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Sousa', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Tibirica', 'Affiliation': 'Department of Research and Education, National Institute of Cardiology, Ministry of Health, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Mauro Felippe Felix', 'Initials': 'MFF', 'LastName': 'Mediano', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil; Department of Research and Education, National Institute of Cardiology, Ministry of Health, Rio de Janeiro, RJ, Brazil.'}]",Microvascular research,['10.1016/j.mvr.2020.104106']
2552,33212256,"Efficacy and Safety of Favipiravir, an Oral RNA-Dependent RNA Polymerase Inhibitor, in Mild-to-Moderate COVID-19: A Randomized, Comparative, Open-Label, Multicenter, Phase 3 Clinical Trial.","OBJECTIVE


To assess efficacy and safety of favipiravir in adults with mild-to-moderate COVID-19.
METHODS


In this randomized, open-label, parallel-arm, multicenter, Phase 3 trial, adults (18-75 years) with RT-PCR-confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) were randomized 1:1 to oral favipiravir (Day 1: 1800 mg BID; Days 2-14: 800 mg BID) plus standard supportive care versus supportive care alone. The primary endpoint was time to cessation of viral shedding; time to clinical cure also was measured.
RESULTS


From May 14-July 3, 2020, 150 patients were randomized to favipiravir (n = 75) or control (n = 75). Median time to cessation of viral shedding was 5 days (95% CI: 4 days, 7 days) versus 7 days (95% CI: 5 days, 8 days),P = 0.129, and median time to clinical cure was 3 days (95% CI: 3 days, 4 days) versus 5 days (95% CI: 4 days, 6 days), P = 0.030, for favipiravir and control, respectively. Adverse events were observed in 36% of favipiravir and 8% of control patients. One control patient died due to worsening disease.
CONCLUSION


Lack of statistical significance on the primary endpoint was confounded by limitations of the RT-PCR assay. Significant improvement in time to clinical cure suggests favipiravir may be beneficial in mild-to-moderate COVID-19.",2020,"Median time to cessation of viral shedding was 5 days (95% CI: 4 days, 7 days) versus 7 days (95% CI: 5 days, 8 days),P = 0.129, and median time to clinical cure was 3 days (95% CI: 3 days, 4 days) versus 5 days (95% CI: 4 days, 6 days), P = 0.030, for favipiravir and control, respectively.","['adults with mild-to-moderate COVID-19', 'Mild-to-Moderate COVID-19', '150 patients were randomized to', 'adults (18-75 years) with RT-PCR-confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic']","['oral favipiravir (Day 1: 1800\u2009mg BID; Days 2-14: 800\u2009mg BID) plus standard supportive care versus supportive care alone', 'Favipiravir, an Oral RNA-Dependent RNA Polymerase Inhibitor', 'favipiravir']","['median time to clinical cure', 'Median time to cessation of viral shedding', 'Adverse events', 'time to cessation of viral shedding; time to clinical cure', 'efficacy and safety of favipiravir']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0035685', 'cui_str': 'RNA-directed RNA polymerase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]",150.0,0.257107,"Median time to cessation of viral shedding was 5 days (95% CI: 4 days, 7 days) versus 7 days (95% CI: 5 days, 8 days),P = 0.129, and median time to clinical cure was 3 days (95% CI: 3 days, 4 days) versus 5 days (95% CI: 4 days, 6 days), P = 0.030, for favipiravir and control, respectively.","[{'ForeName': 'Zarir F', 'Initials': 'ZF', 'LastName': 'Udwadia', 'Affiliation': 'Breach Candy Hospital, Mumbai, India.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Hanmant', 'Initials': 'H', 'LastName': 'Barkate', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Saiprasad', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Shabbir', 'Initials': 'S', 'LastName': 'Rangwala', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Amol', 'Initials': 'A', 'LastName': 'Pendse', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Kadam', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Glenmark Pharmaceuticals Ltd, Waterford, UK.'}, {'ForeName': 'Cynthia F', 'Initials': 'CF', 'LastName': 'Caracta', 'Affiliation': 'Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Mumbai, India. Electronic address: Monika.Tandon@glenmarkpharma.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.11.142']
2553,32997740,Interfacial Evaluation of CAD/CAM Resin Inlays on the Cavity Floor Using Swept-source Optical Coherence Tomography.,"CLINICAL RELEVANCE


When a resin nanoceramic inlay is cemented using self-adhesive cement, a universal dentin adhesive can be applied to the prepared cavity. The application of the adhesive before self-adhesive cement placement provides similar or better interfacial adaptation than without the adhesive.
SUMMARY


Purpose: The first objective of this study was to determine whether the luting material used for computer-aided design and computer-aided manufacture resin nanoceramic inlays affected interfacial adaptation. The second objective was to investigate whether application of a universal dentin adhesive before cementation affected interfacial adaptation. The final objective was to compare the inlay-side and dentin-side interfaces in the cement space.Methods and Materials: Seventy-four class I cavities were prepared on extracted human third molars. Cavities were optically scanned, and resin nanoceramic inlays were milled using Lava Ultimate blocks (3M ESPE). For the control groups, the fabricated inlays were cemented using Panavia V5 (Kuraray Noritake) or FujiCem 2 (GC). For the experimental groups, the teeth were randomly divided into groups I and II. Group I contained four subgroups using different luting materials; in all subgroups, the inlays were cemented and dual cured without pretreatment. Group II contained six subgroups in which inlays were cemented and dual cured after application of a universal dentin adhesive. After thermocycling, interfacial adaptation was measured using swept-source optical coherence tomography (SS-OCT) imaging and statistically compared among groups.Results: Interfacial adaptation was different depending on the luting material used (p<0.05). After application of a universal adhesive, some subgroups showed improved interfacial adaptation (p<0.05). In the comparison of inlay-side and dentin-side interfaces, no difference was found in interfacial adaptation (p>0.05).Conclusions: Interfacial adaptation for resin nanoceramic inlays differed with luting material. For some self-adhesive cements, application of a universal adhesive before cementation improved interfacial adaptation.",2020,"After application of a universal adhesive, some subgroups showed improved interfacial adaptation (p<0.05).",[],[],"['Interfacial adaptation', 'interfacial adaptation']",[],[],"[{'cui': 'C0000934', 'cui_str': 'Acclimation'}]",74.0,0.0163875,"After application of a universal adhesive, some subgroups showed improved interfacial adaptation (p<0.05).","[{'ForeName': 'S-H', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadr', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': ''}, {'ForeName': 'S-E', 'Initials': 'SE', 'LastName': 'Yang', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-141-L']
2554,32336267,Measuring patient experiences in a Children's hospital with a medical clowning intervention: a case-control study.,"BACKGROUND


Because the healthcare sector is shifting to a customer-oriented approach, it is important to understand experiences of children as users of healthcare services. So far, studies that measure the influence of medical clowning on patient experiences are scarce. This study aims to measure experiences of children and their parents during day-surgery in hospital setting.
METHODS


A case-control study was conducted in a large Finnish children's hospital. Seventy children aged 4-17 years coming for a minor operative procedure including pre-operative cannula insertion prior to surgery were included. Thirty-eight children were exposed to the medical clowning intervention and 32 children (the reference group) did not receive exposure to medical clowning. A novel digital survey tool was used to measure patient experiences before and after the insertion of a venous cannula needed for anaesthesia. The children were asked about their emotions, anxiety levels, the pain from the cannula insertion and the best and worst things about the hospital. The parents were asked about their emotions, expectations and the fluency of the procedure and the hospital day.
RESULTS


Before the procedure, 32% or 36% of the children in the intervention group and 44% or 28% of those in the reference group expressed positive or neutral emotions, respectively. After the procedure, 76% or 63% of children in the intervention group or reference group, respectively, expressed positive emotions. The intervention group rated the medical clowns as the best aspect of the hospital day. Both groups reported that the best aspects of the hospital day were related to the nurses and food and the worst were related to waiting and pain. Most commonly the parents felt uncertainty, anxiety or calmness before the procedure and relief afterwards. Their expectations towards the procedure related to its success and the certainty of the diagnosis.
CONCLUSIONS


The results show a trend towards more positive emotions in children with exposure to medical clowning. The digital survey tool was suitable for gathering information about the experiences of children and their parents. Information on emotions and expectations of children and parents during a procedure is useful when improving the quality of healthcare services.
TRIAL REGISTRATION


Current Controlled Trials NCT04312217, date of registration 17.03.2020. Retrospectively registered.",2020,A novel digital survey tool was used to measure patient experiences before and after the insertion of a venous cannula needed for anaesthesia.,"['children and their parents during day-surgery in hospital setting', 'children with exposure to medical clowning', 'Seventy children aged 4-17\u2009years coming for a minor operative procedure including pre-operative cannula insertion prior to surgery were included', ""large Finnish children's hospital"", 'Thirty-eight children', ""Children's hospital with a medical clowning intervention""]",['medical clowning intervention and 32 children (the reference group) did not receive exposure to medical clowning'],"['positive or neutral emotions', 'waiting and pain', 'positive emotions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0585022', 'cui_str': 'During day'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0335094', 'cui_str': 'Clown'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",38.0,0.0367397,A novel digital survey tool was used to measure patient experiences before and after the insertion of a venous cannula needed for anaesthesia.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Karisalmi', 'Affiliation': 'Department of Computer Science, Aalto University, P.O. Box 15400, FI-00076, Aalto, Finland. nina.karisalmi@gmail.com.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Mäenpää', 'Affiliation': 'Department of Computer Science, Aalto University, P.O. Box 15400, FI-00076, Aalto, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kaipio', 'Affiliation': 'Department of Computer Science, Aalto University, P.O. Box 15400, FI-00076, Aalto, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Lahdenne', 'Affiliation': 'Hospital for Children and Adolescents, Helsinki University Hospital, Helsinki, Finland.'}]",BMC health services research,['10.1186/s12913-020-05128-2']
2555,32516395,Clinical Efficacy of Different Dentin Desensitizers.,"CLINICAL RELEVANCE


Teethmate Desensitizer, Clinpro White Varnish, Shield Force Plus, and Gluma could be recommended for treating dentin hypersensitivity in terms of clinical efficacy.
SUMMARY


Objective: The aim of this study was to evaluate the clinical efficacy of widely used dentindesensitizing agents (DDAs) (Teethmate Desensitizer, Clinpro White Varnish, Shield Force Plus, and Gluma) in the treatment of dentin hypersensitivity (DH) according to different evaluation parameters over a four-week follow-up period.Methods and Materials: This study was a randomized, single-center, controlled, parallel group study involving 144 teeth in 40 subjects. The baseline DH levels of the subjects were determined using different evaluation parameters. Daily life hypersensitivity and evaporative air stimulus hypersensitivity scores were recorded using a visual analog scale (VAS), and tactile hypersensitivity scores were recorded using a Yeaple probe and measured in grams and on the VAS. Subjects who experienced evaporative air stimulus DH (30-80 mm on the VAS) and tactile hypersensitivity (10-50 g with the Yeaple probe) were included in the study. After application of the DDAs, these evaluation parameters were recorded throughout the follow-up period (immediately after application and at one day and two and four weeks post-application).Results: All four DDAs demonstrated clinical dentin-desensitizing effects throughout the follow-up period according to evaporative air hypersensitivity, tactile sensitivity (g-VAS), and daily life hypersensitivity scores (p<0.05). Only Clinpro White Varnish had tactile sensitivity (g) scores that were similar at baseline and the one-day follow-up (p>0.05). A comparison of DH-reducing effects among the DDAs revealed that they yielded different results immediately after application and at the one-day follow-up time point, depending on which evaluation parameter was used. However, all DDAs showed similar DH-reducing effects at the two- and four-week follow-up time points.Conclusions: Teethmate Desensitizer, Clinpro White Varnish, Shield Force Plus, and Gluma DH showed clinical efficacy for four weeks. DDAs may produce inconsistent clinical evaluation scores not only across different evaluation parameters but also between early and later follow-up time points.",2020,DDAs may produce inconsistent clinical evaluation scores not only across different evaluation parameters but also between early and later follow-up time points.,"['Subjects who experienced evaporative air stimulus DH (30-80 mm on the VAS) and tactile hypersensitivity (10-50 g with the Yeaple probe) were included in the study', '144 teeth in 40 subjects']","['Methods and Materials', 'Teethmate Desensitizer, Clinpro White Varnish, Shield Force', 'Dentin Desensitizers', 'widely used dentindesensitizing agents (DDAs) (Teethmate Desensitizer, Clinpro White Varnish, Shield Force']","['Daily life hypersensitivity and evaporative air stimulus hypersensitivity scores', 'dentin hypersensitivity (DH', 'evaporative air hypersensitivity, tactile sensitivity (g-VAS), and daily life hypersensitivity scores', 'baseline DH levels', 'tactile sensitivity (g) scores', 'visual analog scale (VAS), and tactile hypersensitivity scores', 'clinical efficacy']","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",144.0,0.0254463,DDAs may produce inconsistent clinical evaluation scores not only across different evaluation parameters but also between early and later follow-up time points.,"[{'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Eyüboğlu', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Naiboğlu', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-258-C']
2556,32599657,Percutaneous insertion of a jejunal tube via the collapsed blind end of elevated jejunum by a balloon puncturing method assisted by a balloon enteroscope.,,2020,,[],[],[],[],[],[],,0.0611949,,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Mie', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Ono', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sasahira', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.794']
2557,32674133,Effect of Layering Techniques on Polymerization Shrinkage Stress of High- and Low-viscosity Bulk-fill Resins.,"CLINICAL RELEVANCE


The use of layering techniques is still advisable with many bulk-fill resins and should be the default unless a particular resin is known to not need it.
SUMMARY


Objective: The purpose of this study was to investigate how layering techniques affect polymerization shrinkage stresses of high-and low-viscosity bulk-fill resins.Method: Six high-viscosity and six low-viscosity bulk-fill resins were evaluated. Aluminum blocks with a mesial-occlusal-distal (MOD) cavity were machined and randomly divided into groups for different filling techniques (bulk-fill vs horizontal layering vs oblique layering) and further subdivided according to type of resin (high- vs low-viscosity). The cuspal deflection resulting from the polymerization of bulk-fill resin bonded to a MOD cavity within an aluminum block was measured with a digimatic micrometer. Scanning electron microscopy analyses of tested resins were also conducted.Results: In the high-viscosity bulk-fill resins, cuspal deflection of the MOD cavity ranged from 11.2 to 18.2 μm with the bulk-filling technique, from 10.7 to 15.5 μm with the horizontal layering technique, and from 10.9 to 15.2 μm with the oblique layering technique. In the low-viscosity bulk-fill resins, cuspal deflection of the material ranged from 9.2 to 19.8 μm with the bulk-filling technique, from 8.2 to 15.7 μm with the horizontal layering technique, and from 8.4 to 16.4 μm with the oblique layering technique.Conclusion: Cuspal deflections for some high-and low-viscosity bulk-fill resins were significantly reduced by using layering techniques, but the resultant improvement of layering techniques was not applicable to all the bulk-fill resins used in this study.",2020,"Conclusion: Cuspal deflections for some high-and low-viscosity bulk-fill resins were significantly reduced by using layering techniques, but the resultant improvement of layering techniques was not applicable to all the bulk-fill resins used in this study.",['Aluminum blocks with a mesial-occlusal-distal (MOD) cavity'],['Layering Techniques'],['Polymerization Shrinkage Stress of High- and Low-viscosity Bulk-fill Resins'],"[{'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0447327', 'cui_str': 'Mesial-occlusal-distal'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}]",6.0,0.0163715,"Conclusion: Cuspal deflections for some high-and low-viscosity bulk-fill resins were significantly reduced by using layering techniques, but the resultant improvement of layering techniques was not applicable to all the bulk-fill resins used in this study.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsujimoto', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Jurado', 'Affiliation': ''}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Barkmeier', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Sayed', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Takamizawa', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Latta', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miyazaki', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Garcia-Godoy', 'Affiliation': ''}]",Operative dentistry,['10.2341/19-217-L']
2558,33212438,Matters of Life and Death: An Experimental Study Investigating Psychological Interventions to Encourage the Readiness for End-of-Life Conversations.,"INTRODUCTION


Talking about death and dying is evoking discomfort in many persons, resulting in avoidance of this topic. However, end-of-life discussions can alleviate distress and uncertainties in both old and young adults, but only a minority uses this option in palliative care. Even in healthy populations, talking about death is often seen as alleviative and worthwhile, but rarely initiated.
OBJECTIVE


To investigate different psychological interventions (a) encouraging the readiness for end-of-life discussions and (b) changing death attitudes in healthy adults of different ages.
METHODS


168 participants were randomized to four different interventions (IG1: value-based intervention with end-of-life perspective, IG2: motivation-based intervention with end-of-life perspective, IG3: combination of IG1 and IG2, CG: control group). Primary outcome was the readiness to engage in end-of-life topics. Secondary outcomes were fear of death, fear of dying and death acceptance. Assessments took place before, directly after the intervention and at 2 weeks of follow up.
RESULTS


IG2 and IG3 reported significantly more changes in the readiness to engage in end-of-life discussions than the CG (F[5.61, 307] = 4.83, p < 0.001, ηp2 = 0.081) directly after the intervention. The effect of IG3 remained stable at the follow-up. There were no significant effects of the interventions on end-of-life fears or death acceptance. Acceptability of the interventions was very high.
CONCLUSIONS


Short interventions can be useful to encourage end-of-life discussions and could be integrated in health care programs. The efficacy and effectiveness of these short interventions in palliative patients are currently examined.",2020,"RESULTS


IG2 and IG3 reported significantly more changes in the readiness to engage in end-of-life discussions than the CG (F[5.61, 307] = 4.83, p < 0.001, ηp2 = 0.081) directly after the intervention.","['healthy adults of different ages', 'palliative patients', '168 participants']","['interventions (IG1: value-based intervention with end-of-life perspective, IG2: motivation-based intervention with end-of-life perspective, IG3: combination of IG1 and IG2, CG: control group']","['Life and Death', 'readiness to engage in end-of-life topics', 'end-of-life fears or death acceptance', 'efficacy and effectiveness', 'fear of death, fear of dying and death acceptance', 'readiness to engage in end-of-life discussions']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319556', 'cui_str': '168'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0522179', 'cui_str': 'Death anxiety'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",168.0,0.0367865,"RESULTS


IG2 and IG3 reported significantly more changes in the readiness to engage in end-of-life discussions than the CG (F[5.61, 307] = 4.83, p < 0.001, ηp2 = 0.081) directly after the intervention.","[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'von Blanckenburg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany, blanckep@uni-marburg.de.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Leppin', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Nagelschmidt', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Seifart', 'Affiliation': 'Institutional Review Board, Clinical Ethics, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Marburg, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000511199']
2559,33212440,Brief Online Cognitive Behavioural Intervention for Dysfunctional Worry Related to the COVID-19 Pandemic: A Randomised Controlled Trial.,"INTRODUCTION


Worries about the immediate and long-term consequences of the COVID-19 pandemic may for some individuals develop into pervasive worry that is disproportionate in its intensity or duration and significantly interferes with everyday life.
OBJECTIVE


The aim of this study was to investigate if a brief self-guided, online psychological intervention can reduce the degree of dysfunctional worry related to the COVID-19 pandemic and associated symptoms.
METHODS


670 adults from the Swedish general population reporting daily uncontrollable worry about CO-VID-19 and its possible consequences (e.g., illness, death, the economy, one's family) were randomised (1:1 ratio) to a 3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration. The primary outcome measure was a COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale administered at baseline and weeks 1-3 (primary endpoint). Follow-up assessments were conducted 1 month after treatment completion. The trial was registered on ClinicalTrials.gov (NCT04341922) before inclusion of the first participant.
RESULTS


The main pre-specified intention-to-treat analysis indicated significant reductions in COVID-19-related worry for the intervention group compared to the waiting list (β = 1.14, Z = 9.27, p < 0.001), corresponding to a medium effect size (bootstrapped d = 0.74 [95% CI: 0.58-0.90]). Improvements were also seen on all secondary measures, including mood, daily functioning, insomnia, and intolerance of uncertainty. Participant satisfaction was high. No serious adverse events were recorded.
CONCLUSIONS


A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.",2020,"CONCLUSIONS


A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.","[""670 adults from the Swedish general population reporting daily uncontrollable worry about CO-VID-19 and its possible consequences (e.g., illness, death, the economy, one's family"", 'Dysfunctional Worry Related to the COVID-19 Pandemic']","['Brief Online Cognitive Behavioural Intervention', 'self-guided, online psychological intervention', '3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration']","['dysfunctional worry and associated behavioural symptoms', 'serious adverse events', 'mood, daily functioning, insomnia, and intolerance of uncertainty', 'COVID-19-related worry', 'COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale']","[{'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",670.0,0.126312,"CONCLUSIONS


A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.","[{'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Wahlund', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden, tove.wahlund@ki.se.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mataix-Cols', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Olofsdotter Lauri', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elles', 'Initials': 'E', 'LastName': 'de Schipper', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Aspvall', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Psychotherapy and psychosomatics,['10.1159/000512843']
2560,33212487,Impact of surgical treatment of pectus carinatum on cardiopulmonary function: a prospective study.,"OBJECTIVES


The frequency of sternochondroplasty in cases of pectus carinatum (PC) has increased due to greater surgeon experience and modified surgical techniques. PC deformity does not usually cause cardiopulmonary malfunction or impairment. However, whether cardiopulmonary function changes after surgical repair remains a matter of controversy. The aim of our prospective study was to determine if surgery changes preoperative cardiopulmonary function.
METHODS


Nineteen patients (16 males, 3 females) were enrolled in a prospective, open-label, single-arm, single-centre clinical trial (Impact of Surgical Treatments of Thoracic Deformation on Cardiopulmonary Function) (NCT02163265) between July 2013 and January 2017. All patients underwent PC repair via a modified Ravitch procedure and wore a lightweight, patient-controlled chest brace for 8 weeks postoperatively (the Innsbruck protocol). The average follow-up surgical examination was 8.3 months after surgery. In all enrolled patients, before surgery and not before 6 months postoperatively chest X-ray, 3-dimensional volume-rendered computed tomography thorax imaging, cardiopulmonary function tests with stepwise cycle spiroergometry (sitting and supine position) and Doppler echocardiography were performed; questionnaires about daily physical activity were also completed.
RESULTS


Fourteen patients (aged 16.3 ± 2.6 years at study entry) completed the study. Changes in submaximal and peak power output were not detected during sitting, or when in the supine position. Also, no clinically relevant postoperative changes in spirometry or echocardiography were noted.
CONCLUSIONS


Our findings confirm that surgical correction of PC does not impair cardiopulmonary function at rest or during physical exercise.
CLINICAL REGISTRATION NUMBER


clinicaltrials.gov NCT02163265.",2020,"Changes in submaximal and peak power output were not detected during sitting, or when in the supine position.","['Nineteen patients (16 males, 3 females', 'Fourteen patients (aged 16.3\u2009±\u20092.6\u2009years at study entry) completed the study']","['PC repair via a modified Ravitch procedure and wore a lightweight, patient-controlled chest brace', 'pectus carinatum']","['cardiopulmonary function', 'Changes in submaximal and peak power output']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0158731', 'cui_str': 'Congenital pectus carinatum'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.026703,"Changes in submaximal and peak power output were not detected during sitting, or when in the supine position.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Del Frari', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Sigl', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'Schwabegger', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Blank', 'Affiliation': 'Department of Psychology and Medical Sciences, Institute of Sports Medicine, Alpine Medicine & Health Tourism (ISAG), University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tyrol, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Morawetz', 'Affiliation': 'Department of Psychology and Medical Sciences, Institute of Sports Medicine, Alpine Medicine & Health Tourism (ISAG), University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tyrol, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Gassner', 'Affiliation': 'Department of Radiology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schobersberger', 'Affiliation': 'Department of Psychology and Medical Sciences, Institute of Sports Medicine, Alpine Medicine & Health Tourism (ISAG), University for Health Sciences, Medical Informatics and Technology (UMIT), Hall in Tyrol, Austria.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezaa335']
2561,33212488,Modest efficacy of nivolumab plus ipilimumab in patients with papillary renal cell carcinoma.,"PURPOSE


Combined immunotherapy of nivolumab plus ipilimumab for intermediate- and poor-risk metastatic clear cell renal cell carcinoma showed prolonged progression-free survival and high objective response rate in a randomized phase III clinical trial. However, the efficacy of this treatment for papillary renal cell carcinoma remains unclear. In the present study, we analysed the efficacy of nivolumab plus ipilimumab therapy for papillary renal cell carcinoma compared with that for clear cell renal cell carcinoma.
MATERIALS AND METHODS


This is a retrospective study of 30 patients with metastatic renal cell carcinoma who received nivolumab and ipilimumab as first-line therapy between December 2015 and May 2020. The objective response rate, progression-free survival and toxicity were compared between the two groups (clear cell renal cell carcinoma and papillary renal cell carcinoma).
RESULTS


Out of 30 patients, 7 and 23 were diagnosed with papillary renal cell carcinoma and clear cell renal cell carcinoma, respectively. With a median follow-up of 7.2 months, the median progression-free survival was significantly shorter in papillary renal cell carcinoma than in clear cell renal cell carcinoma (2.4 vs. 28.1 months, P = 0.014). Of the seven patients with papillary renal cell carcinoma, one had partial response, one had stable disease and five had progressive disease, resulting in an objective response rate of 14.2%, which was lower compared to that of clear cell renal cell carcinoma (14.2 vs. 52.1%, P = 0.06). Discontinuation due to toxicity was not observed with papillary renal cell carcinoma, meanwhile 60.8% of patient with clear cell renal cell carcinoma discontinued treatment due to toxicity.
CONCLUSION


Nivolumab plus ipilimumab had modest efficacy for papillary renal cell carcinoma compared with that for clear cell renal cell carcinoma. Nivolumab plus ipilimumab remains an option for a limited number of patients with intermediate- or poor-risk papillary renal cell carcinoma.",2020,"The objective response rate, progression-free survival and toxicity were compared between the two groups (clear cell renal cell carcinoma and papillary renal cell carcinoma).
","['30 patients with metastatic renal cell carcinoma who received', 'patients with intermediate- or poor-risk papillary renal cell carcinoma', 'intermediate- and poor-risk metastatic clear cell renal cell carcinoma', '7 and 23 were diagnosed with papillary renal cell carcinoma and clear cell renal cell carcinoma, respectively', 'papillary renal cell carcinoma', 'seven patients with papillary renal cell carcinoma', 'as first-line therapy between December 2015 and May 2020', 'patients with papillary renal cell carcinoma']","['nivolumab plus ipilimumab therapy', 'Nivolumab plus ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab and ipilimumab']","['objective response rate, progression-free survival and toxicity', 'clear cell renal cell carcinoma', 'median progression-free survival', 'progressive disease', 'toxicity', 'objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",30.0,0.0233208,"The objective response rate, progression-free survival and toxicity were compared between the two groups (clear cell renal cell carcinoma and papillary renal cell carcinoma).
","[{'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Tachibana', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Tsunenori', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ishihara', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Takagi', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Junpei', 'Initials': 'J', 'LastName': 'Izuka', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.""}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': ""Department of Urology, Tokyo Women's Medical University Tokyo, Tokyo, Japan.""}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa229']
2562,33213015,The Impact of Overnight Orthokeratology on Accommodative Response in Myopic Subjects.,"This study aimed to evaluate the effects of two months of orthokeratology (OK) treatment in the accommodative response of young adult myopes. Twenty eyes (21.8 ± 1.8 years) were fitted with the Paragon CRT ®  100 LENS to treat myopia between -1.00 and -2.00 D. Low- and high-contrast visual acuity (LCDVA and HCDVA), central objective refraction, light disturbance (LD), and objective accommodative response (using the Grand Seiko WAM-5500 open-field autorefractometer coupled with a Badal system) were measured at baseline (BL) before lens wear and after 1, 15, 30, and 60 nights of OK. Refractive error correction was achieved during the first fifty days of OK lens wear, with minimal changes afterwards. LD analysis showed a transient increase followed by a reduction to baseline levels over the first 30 nights of treatment. The accommodative response was lower than expected for all target vergences in all visits (BL: 0.61 D at 1.00 D to 0.96 D at 5.00 D; 60 N: 0.36 D at 1.00 D to 0.79 D at 5.00 D). On average, the accommodative lag decreases over time with OK lens wear. However, these differences were not statistically significant ( p  > 0.050, repeated-measures ANOVA and Friedman test). This shows that overnight OK treatment does not affect objectively measured the accommodative response of young, low myopic eyes after two months of treatment stabilization.",2020,"However, these differences were not statistically significant ( p  > 0.050, repeated-measures ANOVA and Friedman test).","['Twenty eyes (21.8 ± 1.8 years', 'Myopic Subjects', 'young adult myopes']","['orthokeratology (OK', 'Overnight Orthokeratology']","['Refractive error correction', 'accommodative response', 'visual acuity (LCDVA and HCDVA), central objective refraction, light disturbance (LD), and objective accommodative response']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301317', 'cui_str': 'Objective refraction'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0237147,"However, these differences were not statistically significant ( p  > 0.050, repeated-measures ANOVA and Friedman test).","[{'ForeName': 'Ana F', 'Initials': 'AF', 'LastName': 'Pereira-da-Mota', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Costa', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Amorim-de-Sousa', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'González-Méijome', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Queirós', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}]",Journal of clinical medicine,['10.3390/jcm9113687']
2563,33213066,"A Lower Sodium Neapolitan Pizza Prepared with Seawater in Place of Salt: Nutritional Properties, Sensory Characteristics, and Metabolic Effects.","Seawater is rich in minerals which may help confer good palatability to foods, favouring the use of smaller amounts of salt, a recognized measure of cardiovascular prevention. The aim of this study was to investigate the nutritional properties, sensory characteristics and metabolic effects of a typical Neapolitan pizza prepared with seawater (SWP) in place of common salt, in comparison with Standard traditional Pizza (StP). The nutritional characteristics and the chemical profile of the SWP and StP were assessed by chemical analyses and the use of Food Composition Tables. Twelve healthy volunteers were recruited for a Randomized Controlled Trial, with the consumption of one StP and one SWP using a balanced crossover design. The satiating power and palatability of the two pizzas were tested by the administration of Visual Analogue Scales. Serum glucose, insulin and sodium were measured every 30 min and 3 h urines were collected after each meal. SWP contained nearly 50% less NaCl and a larger amount of micronutrients compared with StP. No significant differences were detected between the two pizzas with regard to satiating power, pleasantness and glycemic and insulinemic response. However, a significant difference was found in the urine volume collected over the 3 h after the two meals (194 mL after StP vs. 292 mL after SWP,  p  = 0.018) and in the 3 h sodium balance (+1.6 g after StP vs. +0.5 g after SWP,  p  = 0.002). Conclusions: SWP appears to be a food with favourable nutritional characteristics, very good acceptability and healthy metabolic properties: these results warrant confirmation by a larger intervention trial.",2020,"SWP contained nearly 50% less NaCl and a larger amount of micronutrients compared with StP. No significant differences were detected between the two pizzas with regard to satiating power, pleasantness and glycemic and insulinemic response.","['Twelve healthy volunteers', 'Place of Salt']","['typical Neapolitan pizza prepared with seawater (SWP', 'Standard traditional Pizza (StP', 'SWP']","['SWP', 'urine volume', 'Nutritional Properties, Sensory Characteristics, and Metabolic Effects', 'satiating power, pleasantness and glycemic and insulinemic response', 'Serum glucose, insulin and sodium']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0453577', 'cui_str': 'Pizza'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]",12.0,0.0333132,"SWP contained nearly 50% less NaCl and a larger amount of micronutrients compared with StP. No significant differences were detected between the two pizzas with regard to satiating power, pleasantness and glycemic and insulinemic response.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Iaccarino Idelson', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Napoli, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Russo', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Napoli, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Iacone', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Napoli, Italy.'}, {'ForeName': 'Lanfranco', 'Initials': 'L', 'LastName': ""D'Elia"", 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Napoli, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Giacco', 'Affiliation': 'Bio Agrifood Department, CNR Institute of Food Science, 83100 Avellino, Italy.'}, {'ForeName': 'Maria Grazie', 'Initials': 'MG', 'LastName': 'Volpe', 'Affiliation': 'Bio Agrifood Department, CNR Institute of Food Science, 83100 Avellino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Strazzullo', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Napoli, Italy.'}]",Nutrients,['10.3390/nu12113533']
2564,33213070,Usefulness of Antioxidants as Adjuvant Therapy for Septic Shock: A Randomized Clinical Trial.,"Background and objectives:  Oxidative stress (OS) participates in the pathophysiology of septic shock, which leads to multiple organ failure (MOF), ischemia-reperfusion injury, and acute respiratory distress syndrome. Therefore, antioxidants have been proposed as therapy. Here, we evaluated the effect of antioxidant treatments in patients with septic shock with MOF and determined levels OS before and after treatment. This study was a randomized, controlled, triple-masked, and with parallel assignment clinical trial with a control group without treatment.  Materials and Methods:  It included 97 patients of either sex with septic shock. 5 treatments were used each in an independent group of 18 patients. Group 1 received vitamin C (Vit C), group 2 vitamin E (Vit E), group 3 n-acetylcysteine (NAC), group 4 melatonin (MT), and group 5 served as control. All antioxidants were administered orally or through a nasogastric tube for five days as an adjuvant to the standard therapy.  Results:  The results showed that all patients presented MOF due to sepsis upon admission and that the treatment decreased it ( p  = 0.007). The antioxidant treatment with NAC increased the total antioxidant capacity ( p  < 0.05). The patients that received Vit C had decreased levels of the nitrate and nitrite ratio ( p  < 0.01) and C-reactive protein levels ( p  = 0.04). Procalcitonin levels were reduced by Vit E ( p  = 0.04), NAC ( p  = 0.001), and MT ( p  = 0.04). Lipid-peroxidation was reduced in patients that received MT ( p  = 0.04).  Conclusions:  In conclusion, antioxidant therapy associated with standard therapy reduces MOF, OS, and inflammation in patients with septic shock.",2020,"Procalcitonin levels were reduced by Vit E ( p  = 0.04), NAC ( p  = 0.001), and MT ( p  = 0.04).","['97 patients of either sex with septic shock', 'patients with septic shock with MOF and determined levels OS before and after treatment', 'patients with septic shock', 'Septic Shock']","['antioxidant therapy', 'antioxidant', 'Vit C', 'vitamin C (Vit C), group 2 vitamin E (Vit E), group 3 n-acetylcysteine (NAC), group 4 melatonin (MT), and group 5 served as control', 'Antioxidants']","['Lipid-peroxidation', 'total antioxidant capacity', 'nitrate and nitrite ratio', 'C-reactive protein levels', 'MOF, OS, and inflammation', 'Procalcitonin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C1879713', 'cui_str': 'Antioxidant therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]",97.0,0.462944,"Procalcitonin levels were reduced by Vit E ( p  = 0.04), NAC ( p  = 0.001), and MT ( p  = 0.04).","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Aisa-Alvarez', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Soto', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Guarner-Lans', 'Affiliation': 'Physiology Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Camarena-Alejo', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Juvenal', 'Initials': 'J', 'LastName': 'Franco-Granillo', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Enrique A', 'Initials': 'EA', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gamboa Ávila', 'Affiliation': 'Physiology Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Linaloe', 'Initials': 'L', 'LastName': 'Manzano Pech', 'Affiliation': 'Cardiovascular Biomedicine Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Pérez-Torres', 'Affiliation': 'Cardiovascular Biomedicine Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110619']
2565,33216408,"Reliability, sensitivity, and predictive value of fMRI during multiple object tracking as a marker of cognitive training gain in combination with tDCS in stroke survivors.","Computerized cognitive training (CCT) combined with transcranial direct current stimulation (tDCS) has showed some promise in alleviating cognitive impairments in patients with brain disorders, but the robustness and possible mechanisms are unclear. In this prospective double-blind randomized clinical trial, we investigated the feasibility and effectiveness of combining CCT and tDCS, and tested the predictive value of and training-related changes in fMRI-based brain activation during attentive performance (multiple object tracking) obtained at inclusion, before initiating training, and after the three-weeks intervention in chronic stroke patients (>6 months since hospital admission). Patients were randomized to one of two groups, receiving CCT and either (a) tDCS targeting left dorsolateral prefrontal cortex (1 mA), or (b) sham tDCS, with 40s active stimulation (1 mA) before fade out of the current. Of note, 77 patients were enrolled in the study, 54 completed the cognitive training, and 48 completed all training and MRI sessions. We found significant improvement in performance across all trained tasks, but no additional gain of tDCS. fMRI-based brain activation showed high reliability, and higher cognitive performance was associated with increased tracking-related activation in the dorsal attention network and default mode network as well as anterior cingulate after compared to before the intervention. We found no significant associations between cognitive gain and brain activation measured before training or in the difference in activation after intervention. Combined, these results show significant training effects on trained cognitive tasks in stroke survivors, with no clear evidence of additional gain of concurrent tDCS.",2020,"fMRI-based brain activation showed high reliability, and higher cognitive performance was associated with increased tracking-related activation in the dorsal attention network and default mode network as well as anterior cingulate after compared to before the intervention.","['77 patients were enrolled in the study, 54 completed the cognitive training, and 48 completed all training and MRI sessions', 'chronic stroke patients (>6\u2009months since hospital admission', 'stroke survivors', 'patients with brain disorders']","['CCT and tDCS', 'Computerized cognitive training (CCT) combined with transcranial direct current stimulation (tDCS', 'CCT and either (a) tDCS targeting left dorsolateral prefrontal cortex (1 mA), or (b) sham tDCS, with 40s active stimulation']","['cognitive performance', 'trained cognitive tasks', 'Reliability, sensitivity, and predictive value of fMRI', 'cognitive gain and brain activation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006111', 'cui_str': 'Disorder of brain'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",77.0,0.0399813,"fMRI-based brain activation showed high reliability, and higher cognitive performance was associated with increased tracking-related activation in the dorsal attention network and default mode network as well as anterior cingulate after compared to before the intervention.","[{'ForeName': 'Knut K', 'Initials': 'KK', 'LastName': 'Kolskår', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Richard', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Alnaes', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Erlend S', 'Initials': 'ES', 'LastName': 'Dørum', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Marthe', 'Initials': 'AM', 'LastName': 'Sanders', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Ulrichsen', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jennifer Monereo', 'Initials': 'JM', 'LastName': 'Sánchez', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ihle-Hansen', 'Affiliation': 'Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Nordvik', 'Affiliation': 'Catosenteret Rehabilitation Center, Son, Norway.'}, {'ForeName': 'Lars T', 'Initials': 'LT', 'LastName': 'Westlye', 'Affiliation': 'NORMENT, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",Human brain mapping,['10.1002/hbm.25284']
2566,33216421,"Effects of quercetin supplementation on inflammatory factors and quality of life in post-myocardial infarction patients: A double blind, placebo-controlled, randomized clinical trial.","Myocardial infarction (MI) is one of the leading causes of death in the world. Epidemiological studies have shown that dietary flavonoids are inversely related to cardiovascular morbidity and mortality. The study aimed to determine whether quercetin supplementation can improve inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL) in patients following MI. This randomized double-blind, placebo-controlled trial was conducted on 88 post-MI patients. Participants were randomly assigned into quercetin (n = 44) and placebo groups (n = 44) receiving 500 mg/day quercetin or placebo tablets for 8 weeks. Quercetin supplementation significantly increased serum TAC compared to placebo (Difference: 0.24 (0.01) mmol/L and 0.00 (0.00) mmol/L respectively; p < .001). TNF-α levels significantly decreased in the quercetin group (p = .009); this was not, however, significant compared to the placebo group. As for QOL dimensions, quercetin significantly lowered the scores of insecurity (Difference: -0.66 (12.5) and 0.00 (5.55) respectively; p < .001). No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups. Quercetin supplementation (500 mg/day) in post-MI patients for 8 weeks significantly elevated TAC and improved the insecurity dimension of QOL, but failed to show any significant effect on inflammatory factors, blood pressure and other QOL dimensions.",2020,"No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups.","['post-myocardial infarction patients', 'patients following MI', '88 post-MI patients']","['placebo', 'quercetin', 'Quercetin supplementation', 'placebo groups (n =\u200944) receiving 500\u2009mg/day quercetin or placebo tablets', 'quercetin supplementation']","['IL-6, hs-CRP, blood pressure and other QOL dimensions', 'inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL', 'inflammatory factors and quality of life', 'serum TAC', 'insecurity dimension of QOL', 'inflammatory factors, blood pressure and other QOL dimensions', 'Myocardial infarction (MI', 'cardiovascular morbidity and mortality', 'TNF-α levels']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0233497', 'cui_str': 'Insecurity'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.529179,"No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups.","[{'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Dehghani', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Hashem', 'Initials': 'SH', 'LastName': 'Sezavar Seyedi Jandaghi', 'Affiliation': 'Rasool Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadtaghi', 'Initials': 'M', 'LastName': 'Sarebanhassanabadi', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Emamat', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition and Dietetics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6955']
2567,33216463,Depressive Symptoms and the Effectiveness of a Urate-Lowering Therapy in a Clinical Trial.,"OBJECTIVE


This ancillary study examined the impact of depressive symptoms on the effectiveness of a urate-lowering therapy in the context of a clinical trial.
METHODS


Participants included 67 adults (ages 18-40) with elevated blood pressure who were enrolled in a double-blind, randomized, crossover clinical trial evaluating the effectiveness of allopurinol (300 mg/d) versus placebo to decrease blood pressure. Depressive symptoms were measured at the beginning of each 4-week phase with the Center for Epidemiological Studies Depression scale (CESD-10). Serum urate (sUA) was assessed at the beginning and end of each treatment phase. Compliance to treatment was measured by having detectable oxypurinol levels. Linear regressions tested associations between depressive symptoms and change in sUA in each phase, adjusting for sex and race. Logistic regression predicted compliance from depressive symptoms.
RESULTS


Participants had a mean age of 27 years and were 64% male and 39% African American. sUA levels decreased during the allopurinol treatment period but did not change during the placebo period. Higher depressive symptoms at pretreatment were associated with an attenuated urate-lowering response during the allopurinol phase (β = 0.24, p < 0.05), but had no effect on sUA changes during the placebo phase. Depressive symptoms were not associated with treatment compliance assessed by oxypurinol levels.
CONCLUSION


Depressive symptoms were associated with reduced efficacy of allopurinol treatment for hyperuricemia in a clinical trial targeting hypertension. Studies evaluating the efficacy of urate-lowering therapies may benefit from screening for depressive symptoms.",2020,"Depressive symptoms were not associated with treatment compliance assessed by oxypurinol levels.
","['Participants included 67 adults (ages 18-40) with elevated blood pressure who were enrolled', 'Participants had a mean age of 27 years and were 64% male and 39% African American. sUA']","['urate-lowering therapy', 'placebo', 'allopurinol', 'Urate-Lowering Therapy', 'urate-lowering therapies']","['Depressive Symptoms', 'levels', 'Depressive symptoms', 'Serum urate (sUA', 'Higher depressive symptoms', 'sUA changes', 'depressive symptoms and change in sUA', 'blood pressure']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}]","[{'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",67.0,0.513456,"Depressive symptoms were not associated with treatment compliance assessed by oxypurinol levels.
","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Mrug', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Catheryn', 'Initials': 'C', 'LastName': 'Orihuela', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rahn', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mudano', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Gaffo', 'Affiliation': 'University of Alabama at Birmingham and Birmingham VA Medical Center, Birmingham, Alabama.'}]",ACR open rheumatology,['10.1002/acr2.11192']
2568,31729189,Safety of baricitinib in East Asian patients with moderate-to-severe active rheumatoid arthritis: An integrated analysis from clinical trials.,"AIM


We evaluated the safety of baricitinib in an East Asian (EA) patient population with moderate-to-severely active rheumatoid arthritis (RA), through an integrated sub-analysis of data from the overall baricitinib RA clinical program.
METHODS


Data from EA patients who received any dose of baricitinib from five completed studies (1 Phase 2, 4 Phase 3) and an ongoing long-term extension study were pooled up to 1 September, 2016. Exposure-adjusted incidence rates (EAIR) and incidence rates (IRs), both per 100 patient-years (PY), were calculated.
RESULTS


This analysis included 740 EA patients with 1294 PY of total baricitinib exposure (maximum 3.5 years). Overall, 109 patients discontinued baricitinib due to adverse events (AEs); EAIR: 8.4. No deaths were reported in this cohort. Serious AEs were reported by 125 patients (EAIR: 9.7). Serious infections were the most common serious AEs (n = 53, IR: 4.15). IR of herpes zoster infection was 6.2; the majority of events were of mild-to-moderate severity. Three cases (IR: 0.23) of tuberculosis were reported. The IRs of malignancy (excluding non-melanoma skin cancer) was 0.99 and EAIR specifically of lymphoma was 0.1. The IR of major adverse cardiovascular events was 0.26, and deep vein thrombosis was reported in four patients (EAIR: 0.3). Two cases of gastrointestinal perforations (EAIR: 0.2) were reported.
CONCLUSION


Integrated data show that baricitinib is well-tolerated in EA patients with moderate-to-severely active RA in the context of demonstrated efficacy, which is generally consistent with safety results of the overall study population.",2020,"Serious infections were the most common serious AEs (n = 53, IR: 4.15).","['740 EA patients with 1294 PY of total baricitinib exposure (maximum 3.5\xa0years', 'East Asian patients with moderate-to-severe active rheumatoid arthritis', 'Data from EA patients who received any dose of baricitinib from five completed studies (1 Phase 2, 4 Phase 3) and an ongoing long-term extension study were pooled up to 1 September, 2016', 'East Asian (EA) patient population with moderate-to-severely active rheumatoid arthritis (RA']",['baricitinib'],"['IR of major adverse cardiovascular events', 'deep vein thrombosis', 'Exposure-adjusted incidence rates (EAIR) and incidence rates (IRs), both per 100 patient-years (PY', 'IR of herpes zoster infection']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",740.0,0.0743985,"Serious infections were the most common serious AEs (n = 53, IR: 4.15).","[{'ForeName': 'Ying-Chou', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Yoo', 'Affiliation': 'Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.'}, {'ForeName': 'Chang Keun', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Ko-Jen', 'Initials': 'KJ', 'LastName': 'Li', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ji-Eon', 'Initials': 'JE', 'LastName': 'Won', 'Affiliation': 'Eli Lilly Korea, Seoul, Korea.'}, {'ForeName': 'Wen-Shuo', 'Initials': 'WS', 'LastName': 'Wu', 'Affiliation': 'Eli Lilly and Company (Taiwan) Inc., Taipei, Taiwan.'}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'IQVIA, Inc., Durham, NC, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nicolay', 'Affiliation': 'Lilly Deutschland GmbH, Bad Homburg, Germany.'}, {'ForeName': 'Chad Daniel', 'Initials': 'CD', 'LastName': 'Walls', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13748']
2569,33219590,Benefits of the application of heat and pressure on peripheral venous cannulation in adults: A randomized controlled trial.,"AIM


To evaluate the effectiveness of the application of topical heat, high pressure or a combination of both on antebrachial venous cannulation.
DESIGN


A cross-over clinical trial blinded for haemolysis analysis.
METHODS


This cross-over clinical trial with two periods was performed in the Clinical Trial Unit of Hospital Universitario de La Princesa (Madrid) during June-July of 2017 in 59 healthy adults who were randomly allocated to one of three interventions: (1) Using dry topical heat for 7 min produced by two hot seed bags (N = 21), (2) Applying controlled pressure from a sphygmomanometer inflated to 100 mmHg (N = 18) and (3) combining heat and pressure (N = 20) in one period out of two. All interventions were contrasted to standard clinical practice in the other period. The comparator involved a standard tourniquet around the upper arm to restrict venous blood flow. The primary outcome was effectiveness measured as vein cannulation at first attempt. Secondary outcomes were vein perception, pain, haemolysis in blood samples and adverse events.
RESULTS


All the interventions were more effective than comparator. Vein perception was optimized in about all individuals. Moreover, pain relief was significantly higher when high pressure was applied. Haemolysis was not affected in any of the three interventions. In addition, no serious adverse events appeared.
CONCLUSION


High pressure is determined to be the most effective in vein catheterization, pain relief, vein perception and quality of blood sample inalterability. Moreover, it is safe considering that only one adverse event appeared.
IMPACT


Vein cannulation is a very common invasive technique, where repeated failures have been registered. Thus, we consider it relevant to develop interventions to achieve venous catheterization at first attempt to alleviate the pain and anxiety associated with this technique. We advocate using high pressure intervention for emergency, due to swiftest method and feasible in case of lacking resources, such as sphygmomanometers in the ambulance. Interventions can be extrapolated to healthy young adults, adults and patients who have healthy vein status perception. Pressure intervention could be an alternative to heat intervention when performing vein cannulation due to its lower risk of transient paresthesia for older people who often suffer from arterial hypertension.",2020,Haemolysis was not affected in any of the three interventions.,"['adults', 'older people who often suffer from arterial hypertension', 'Clinical Trial Unit of Hospital Universitario de La Princesa (Madrid) during June-July of 2017 in 59 healthy adults', 'healthy young adults, adults and patients who have healthy vein status perception']","['Vein cannulation', 'dry topical heat for 7\xa0min produced by two hot seed bags (N\xa0=\xa021), (2) Applying controlled pressure from a sphygmomanometer inflated to 100\xa0mmHg (N\xa0=\xa018) and (3) combining heat and pressure', 'Pressure intervention', 'heat and pressure']","['pain relief', 'effectiveness measured as vein cannulation', 'Haemolysis', 'Vein perception', 'vein perception, pain, haemolysis in blood samples and adverse events', 'vein catheterization, pain relief, vein perception and quality of blood sample inalterability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0183427', 'cui_str': 'Sphygmomanometer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",59.0,0.058046,Haemolysis was not affected in any of the three interventions.,"[{'ForeName': 'Leticia Carmen', 'Initials': 'LC', 'LastName': 'Simón-López', 'Affiliation': 'Nursing and Physiotherapy Department, Universidad de Alcalá (UAH), Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Luquero-Bueno', 'Affiliation': 'Biobank Department, Hospital Universitario de la Princesa, Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Ovejero-Benito', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cuesta-Lozano', 'Affiliation': 'Nursing and Physiotherapy Department, Universidad de Alcalá (UAH), Madrid, Spain.'}, {'ForeName': 'Jessica Marian', 'Initials': 'JM', 'LastName': 'Goodman-Casanova', 'Affiliation': 'Nursing and Physiotherapy Department, Universidad de Alcalá (UAH), Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Vargas-Castrillón', 'Affiliation': 'Clinical Pharmacology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.'}, {'ForeName': 'Dolores Ochoa', 'Initials': 'DO', 'LastName': 'Mazarro', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De Miguel-Cáceres', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria la Princesa (IIS-IP), Madrid, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Posada-Moreno', 'Affiliation': 'Nursing Department, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Zaragoza-García', 'Affiliation': 'Nursing Department, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Ortuño-Soriano', 'Affiliation': 'Nursing Department, Universidad Complutense de Madrid, Madrid, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14655']
2570,33219603,Within-person associations between racial microaggressions and sleep among African American and Latinx young adults.,"Emerging work suggests that experiences of racial discrimination may impact overall sleep health; however, there is limited work on the link between racial microaggressions and sleep. Using weekly diary data, the current study examined young adults' weekly reports of racial microaggressions across 4 weeks, and their relation to weekly reports of sleep-onset latency, reduced total sleep time and poorer sleep quality. This design allowed us to examine how within-person fluctuations in racial microaggressions corresponded with young adults' sleep. Data were collected among 140 African American (62.1%) and Latinx (37.9%) college students attending a Midwestern University. Students were randomly selected to participate; they were, on average, 20.70 years old (SD = 1.22) and the majority were female (69.3%). Participants self-reported their racial microaggressions and sleep behaviours (i.e. sleep-onset latency, total sleep time and sleep quality) each week (across 4 weeks). Multilevel modelling showed significant within-person effects of racial microaggressions for sleep onset and sleep quality, but not for total sleep duration. Specifically, on weeks that individuals reported increases in racial microaggressions, they reported greater sleep-onset duration and poorer sleep quality. The current findings provide preliminary evidence that racial microaggressions are associated with sleep-onset durations and sleep quality among African American and Latinx young adults. Although racial microaggressions are often considered subtle, they may impact the sleep health of young adults in marginalized groups.",2020,"Multilevel modelling showed significant within-person effects of racial microaggressions for sleep onset and sleep quality, but not for total sleep duration.","['Students were randomly selected to participate; they were, on average, 20.70\xa0years old (SD\xa0=\xa01.22) and the majority were female (69.3', '140 African American (62.1%) and Latinx (37.9%) college students attending a Midwestern University', 'African American and Latinx young adults']",[],"['sleep onset and sleep quality', 'racial microaggressions', 'total sleep time and poorer sleep quality', 'total sleep duration', 'racial microaggressions and sleep behaviours (i.e. sleep-onset latency, total sleep time and sleep quality', 'sleep-onset durations and sleep quality', 'sleep-onset duration and poorer sleep quality']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",140.0,0.0266672,"Multilevel modelling showed significant within-person effects of racial microaggressions for sleep onset and sleep quality, but not for total sleep duration.","[{'ForeName': 'Mattina A', 'Initials': 'MA', 'LastName': 'Davenport', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Antoinette M', 'Initials': 'AM', 'LastName': 'Landor', 'Affiliation': 'Department of Human Development and Family Science, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Katharine H', 'Initials': 'KH', 'LastName': 'Zeiders', 'Affiliation': 'Norton School of Family and Consumer Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Evelyn D', 'Initials': 'ED', 'LastName': 'Sarsar', 'Affiliation': 'Norton School of Family and Consumer Sciences, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Flores', 'Affiliation': 'The Center on Border Health Disparities, University of Arizona, Tucson, AZ, USA.'}]",Journal of sleep research,['10.1111/jsr.13226']
2571,33219618,Comprehensive Genomic Profiling of Carcinoma of Unknown Primary Origin: Retrospective Molecular Classification Considering the CUPISCO Study Design.,"BACKGROUND


Carcinoma of unknown primary origin (CUP) accounts for 2%-5% of newly diagnosed advanced malignancies, with chemotherapy as the standard of care. CUPISCO (NCT03498521) is an ongoing randomized trial using comprehensive genomic profiling (CGP) to assign patients with CUP to targeted or immunotherapy treatment arms based on genomic profiling. We performed a retrospective analysis of CUP cases referred for CGP to determine how many were potentially eligible for enrollment into an experimental CUPISCO arm.
MATERIALS AND METHODS


Centrally reviewed adenocarcinoma and undifferentiated CUP specimens in the FoundationCore database were analyzed using the hybrid capture-based FoundationOne CDx assay (mean coverage, >600×). Presence of genomic alterations, microsatellite instability (MSI), tumor mutational burden (TMB), genomic loss of heterozygosity (gLOH), and programmed death-ligand 1 (PD-L1) positivity were determined.
RESULTS


A total of 96 of 303 patients (31.7%) could be matched to an experimental CUPISCO arm. Key genomic alterations included ERBB2 (7.3%), PIK3CA (6.3%), NF1 (5.6%), NF2 (4.6%), BRAF (4.3%), IDH1 (3.3%), PTEN, FGFR2, EGFR (3.6% each), MET (4.3%), CDK6 (3.0%), FBXW7, CDK4 (2.3% each), IDH2, RET, ROS1, NTRK (1.0% each), and ALK (0.7%). Median TMB was 3.75 mutations per megabyte of DNA; 34 patients (11.6%) had a TMB greater or equal to 16 mutations per megabyte. Three patients (1%) had high MSI, and 42 (14%) displayed high PD-L1 expression (tumor proportion score ≥50%). gLOH could be assessed in 199 or 303 specimens; 19.6% had a score of >16%.
CONCLUSIONS


Thirty-two percent of patients would have been eligible for targeted therapy in CUPISCO. Future studies, including additional biomarkers such as PD-L1 positivity and gLOH, may identify a greater proportion potentially benefiting from CGP-informed treatment. Clinical trial identification number. NCT03498521 IMPLICATIONS FOR PRACTICE: The findings of this retrospective analysis of carcinoma of unknown primary origin (CUP) cases validate the experimental treatment arms being used in the CUPISCO study (NCT03498521), an ongoing randomized trial using comprehensive genomic profiling to assign patients with CUP to targeted or immunotherapy treatment arms based on the presence of pathogenic genomic alterations. The findings also suggest that future studies including additional biomarkers and treatment arms, like programmed death-ligand 1 positivity and genomic loss of heterozygosity, may identify a greater proportion of patients with CUP potentially benefiting from comprehensive genomic profiling-informed treatment.",2020,Median TMB was 3.75 mutations per megabyte of DNA; 34 patients (11.6%) had a TMB greater or equal to 16 mutations per megabyte.,"['Centrally reviewed adenocarcinoma and undifferentiated CUP specimens in the FoundationCore database were analyzed using the hybrid capture-based FoundationOne CDx assay (mean coverage, >600×', 'A total of 96 of 303 patients (31.7%) could be matched to an experimental CUPISCO arm']",['NCT03498521'],"['genomic alterations, microsatellite instability (MSI), tumor mutational burden (TMB), genomic loss of heterozygosity (gLOH), and programmed death-ligand 1 (PD-L1) positivity', 'NF2', 'ERBB2', 'Median TMB', 'NF1', 'gLOH', 'high PD-L1 expression', 'BRAF', 'IDH1']","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0205698', 'cui_str': 'Carcinoma, undifferentiated'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007538', 'cui_str': 'Cefadroxil'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708784', 'cui_str': '31.7'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",[],"[{'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0524869', 'cui_str': 'Heterozygosity, Loss of'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}]",303.0,0.0825499,Median TMB was 3.75 mutations per megabyte of DNA; 34 patients (11.6%) had a TMB greater or equal to 16 mutations per megabyte.,"[{'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Ross', 'Affiliation': 'Foundation Medicine, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Ethan S', 'Initials': 'ES', 'LastName': 'Sokol', 'Affiliation': 'Foundation Medicine, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Moch', 'Affiliation': 'University of Zurich and University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Baciarello', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Losa', 'Affiliation': 'Hospital de Sant Joan Despí Moisès Broggi, Barcelona, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beringer', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Elvin', 'Affiliation': 'Foundation Medicine, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nhu', 'Initials': 'N', 'LastName': 'Ngo', 'Affiliation': 'Foundation Medicine, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Dexter X', 'Initials': 'DX', 'LastName': 'Jin', 'Affiliation': 'Foundation Medicine, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'German Cancer Research Center (DKFZ) and University of Heidelberg, Heidelberg, Germany.'}]",The oncologist,['10.1002/onco.13597']
2572,33219629,Does insufficient sleep affect how you learn from reward or punishment? Reinforcement learning after 2 nights of sleep restriction.,"To learn from feedback (trial and error) is essential for all species. Insufficient sleep has been found to reduce the sensitivity to feedback as well as increase reward sensitivity. To determine whether insufficient sleep alters learning from positive and negative feedback, healthy participants (n = 32, mean age 29.0 years, 18 women) were tested once after normal sleep (8 hr time in bed for 2 nights) and once after 2 nights of sleep restriction (4 hr/night) on a probabilistic selection task where learning behaviour was evaluated in three ways: as generalised learning, short-term win-stay/lose-shift learning strategies, and trial-by-trial learning rate. Sleep restriction did not alter the sensitivity to either positive or negative feedback on generalised learning. Also, short-term win-stay/lose-shift strategies were not affected by sleep restriction. Similarly, results from computational models that assess the trial-by-trial update of stimuli value demonstrated no difference between sleep conditions after the first block. However, a slower learning rate from negative feedback when evaluating all learning blocks was found after sleep restriction. Despite a marked increase in sleepiness and slowed learning rate for negative feedback, sleep restriction did not appear to alter strategies and generalisation of learning from positive or negative feedback.",2020,"Despite a marked increase in sleepiness and slowed learning rate for negative feedback, sleep restriction did not appear to alter strategies and generalisation of learning from positive or negative feedback.","['positive and negative feedback, healthy participants (n\xa0=\xa032, mean age 29.0\xa0years, 18 women']","['normal sleep (8\xa0hr time in bed for 2\xa0nights) and once after 2\xa0nights of sleep restriction (4\xa0hr/night) on a probabilistic selection task where learning behaviour was evaluated in three ways: as generalised learning, short-term win-stay/lose-shift learning strategies, and trial-by-trial learning rate', 'Reinforcement learning']","['sleepiness and slowed learning rate for negative feedback, sleep restriction']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.0191031,"Despite a marked increase in sleepiness and slowed learning rate for negative feedback, sleep restriction did not appear to alter strategies and generalisation of learning from positive or negative feedback.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gerhardsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Danja K', 'Initials': 'DK', 'LastName': 'Porada', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Lundström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schwarz', 'Affiliation': 'Department of Psychology, Stress Research Institute, Stockholm University, Stockholm, Sweden.'}]",Journal of sleep research,['10.1111/jsr.13236']
2573,33212355,Effectiveness of the fall prevention intervention in older adults with arterial hypertension: randomized clinical trial.,"OBJECTIVE


To evaluate the effectiveness of the nursing intervention Fall Prevention in reducing falls in older adults with arterial hypertension.
METHODS


Pilot clinical trial, with 118 participants with arterial hypertension from a city in the Northeast of Brazil. Participants were allocated by simple randomization into two groups: intervention (n = 58) and control (n = 60). The intervention was carried out at the participants' homes and consisted of guidelines for modifying environmental and behavioral risk factors for falls. A protocol with nursing activities associated with the Fall Prevention intervention proposed in the Nursing Interventions Classification (NIC) taxonomy was used. The outcome was the self-reported occurrence of falls.
RESULTS


There was a significant difference between the groups in the frequency of self-reported falls (p=0.38) with fewer falls occurring in the intervention group. Sixteen participants fell, of which 5.1% attributed the fall to difficulty walking, 6.8% fell in the living room, 3.4% had a sprain, and 6.8% reported to be afraid to fall again.
CONCLUSION


The nursing intervention Fall Prevention was effective in reducing the occurrence of falls in older adults with arterial hypertension. These findings contribute to the advancement of clinical protocols for the prevention of falls in older adults, as the educational intervention investigated is applicable to different sociodemographic and cultural scenarios.",2020,There was a significant difference between the groups in the frequency of self-reported falls (p=0.38) with fewer falls occurring in the intervention group.,"['older adults with arterial hypertension', 'older adults', '118 participants with arterial hypertension from a city in the Northeast of Brazil']","['fall prevention intervention', 'nursing intervention Fall Prevention', 'nursing intervention']","['self-reported occurrence of falls', 'frequency of self-reported falls']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",118.0,0.0225239,There was a significant difference between the groups in the frequency of self-reported falls (p=0.38) with fewer falls occurring in the intervention group.,"[{'ForeName': 'Francisca Valuzia Guedes', 'Initials': 'FVG', 'LastName': 'Guerra', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: valuziaguedesguerra@gmail.com.'}, {'ForeName': 'Rafaella Pessoa', 'Initials': 'RP', 'LastName': 'Moreira', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: rafaellapessoa@unilab.edu.br.'}, {'ForeName': 'Glauciano', 'Initials': 'G', 'LastName': 'de Oliveira Ferreira', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: glaucianobr86@gmail.com.'}, {'ForeName': 'Janiel Ferreira', 'Initials': 'JF', 'LastName': 'Felício', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: janielferreirafelicio@gmail.com.'}, {'ForeName': 'Tahissa Frota', 'Initials': 'TF', 'LastName': 'Cavalcante', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: tahissa@unilab.edu.br.'}, {'ForeName': 'Thelma Leite', 'Initials': 'TL', 'LastName': 'de Araujo', 'Affiliation': 'Nursing Departament, Federal University of Ceará, 1115 Alexandre Baraúna St., 60430-160, Fortaleza, CE, Brazil. Electronic address: thelmaaraujo2012@gmail.com.'}, {'ForeName': 'Marcio Flavio Moura', 'Initials': 'MFM', 'LastName': 'de Araujo', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: oicam29@gmail.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.11.002']
2574,33212360,Efficacy of a decision support intervention for reducing decisional conflict in patients with elevated serum prostate-specific antigen: A randomized controlled trial.,"PURPOSE


The study purpose is to test the efficacy of a decision support intervention for reducing decisional conflict, increasing prostate biopsy knowledge, and enhancing decision self-efficacy in patients with elevated serum prostate-specific antigen.
METHOD


The study is based on a randomized pre-post test design. A convenience sample of men with elevated prostate-specific antigen was recruited and 1:1 randomized to the intervention and control groups. The intervention group received the decision support intervention and the control group received health education. Data were collected at the baseline and post-test by using self-reported questionnaires, including the Prostate Biopsy Knowledge Scale, the Decision Self-Efficacy Scale, the Decisional Conflict Scale, and questions regarding the prostate biopsy decision (post-test only). Data on prostate-specific antigen levels were collected from the patients' medical records.
RESULTS


A total of 110 patients participated in the study. At baseline, the intervention group had significantly higher knowledge scores than the control group. The analysis of the covariance model with the baseline score as a covariate was used to analyze the intervention effect. After controlling for the baseline scores, the mean differences (95% CI) between the two groups were 11.75 (11.17-12.32), 76.45 (72.52-80.37), and -23.53 (-26.31-20.20) for knowledge, decision self-efficacy, and decisional conflict, respectively. The between-group difference in willingness to accept prostate biopsy at the post-test was not statistically significant (χ 2 = 1.704).
CONCLUSIONS


The decision support intervention significantly reduced patients' decisional conflict while improving their knowledge and self-efficacy. However, the intervention did not affect patients' biopsy decision.",2020,"At baseline, the intervention group had significantly higher knowledge scores than the control group.","['men with elevated prostate-specific antigen', ""patients' medical records"", 'patients with elevated serum prostate-specific antigen', '110 patients participated in the study']","['decision support intervention', 'decision support intervention and the control group received health education']","[""patients' decisional conflict"", 'Prostate Biopsy Knowledge Scale, the Decision Self-Efficacy Scale, the Decisional Conflict Scale, and questions regarding the prostate biopsy decision', 'willingness to accept prostate biopsy', 'knowledge and self-efficacy', 'knowledge, decision self-efficacy, and decisional conflict', 'knowledge scores', 'decisional conflict']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",110.0,0.0369011,"At baseline, the intervention group had significantly higher knowledge scores than the control group.","[{'ForeName': 'Tsae-Jyy', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': ', School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: tsaejyy@ntunhs.edu.tw.'}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: kyoto.sakura0106@gmail.com.'}, {'ForeName': 'Kuang-Kuo', 'Initials': 'KK', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: kkchen@vghtpe.gov.tw.'}, {'ForeName': 'Lun-Ping', 'Initials': 'LP', 'LastName': 'Hung', 'Affiliation': 'Department of Information Management, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: lunping@ntunhs.edu.tw.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101865']
2575,33212902,"Effects of Muscle Strengthening around the Hip on Pain, Physical Function, and Gait in Elderly Patients with Total Knee Arthroplasty: A Randomized Controlled Trial.","Background : Functional limitations may still remain even after a patient completes a traditional quadriceps-based rehabilitative program after total knee arthroplasty. Based on studies reporting that patients with knee osteoarthritis have muscle weakness around the hip joint after total knee arthroplasty, we investigated whether strengthening the hip muscles can reduce pain and improve the physical function and gait of patients who underwent total knee arthroplasty.  Methods : Patients were randomly divided into three groups: hip, quadriceps, and control. The hip group ( n  = 19) completed an extensor, adductor, and external muscle strengthening exercise program. The quadriceps group ( n  = 20) completed a quadriceps strengthening exercise program. The control group ( n  = 16) completed an active range of motion exercises. Therapy was conducted thrice weekly for 12 weeks. Pain and function items from the Western Ontario and McMaster Universities Osteoarthritis Index, Alternate Step Test, Five Times Sit to Stand Test, and Single Leg Stance Test were performed to assess pain and physical function. In the gait analysis, stride, single-stance (%), double-stance (%), and gait speed were measured. Data were collected at baseline and at 4, 8, and 12 weeks after the intervention.  Results : The hip group showed more significant improvements in pain and performance on the Alternate Step Test and Single Leg Stance Test than the quadriceps and control groups. In the gait analysis, the hip group showed the largest improvements in single stance and double stance.  Conclusions : In conclusion, a 12-week hip muscle strengthening exercise program effectively improves the physical function and gait of patients who have undergone total knee arthroplasty.",2020,The hip group showed more significant improvements in pain and performance on the Alternate Step Test and Single Leg Stance Test than the quadriceps and control groups.,"['patients who underwent total knee arthroplasty', 'patients with knee osteoarthritis have muscle weakness around the hip joint after total knee arthroplasty', 'patients who have undergone total knee arthroplasty', 'Elderly Patients with Total Knee Arthroplasty']","['quadriceps strengthening exercise program', 'extensor, adductor, and external muscle strengthening exercise program', 'active range of motion exercises', 'Muscle Strengthening', 'hip muscle strengthening exercise program']","['Pain, Physical Function, and Gait', 'pain and physical function', 'physical function and gait', 'single stance and double stance', 'double-stance (%), and gait speed', 'pain and performance on the Alternate Step Test and Single Leg Stance Test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0482437,The hip group showed more significant improvements in pain and performance on the Alternate Step Test and Single Leg Stance Test than the quadriceps and control groups.,"[{'ForeName': 'KwangSun', 'Initials': 'K', 'LastName': 'Do', 'Affiliation': 'Department of Physical Therapy, Graduate School of Sahmyook University, Seoul 01795, Korea.'}, {'ForeName': 'JongEun', 'Initials': 'J', 'LastName': 'Yim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Sahmyook University, Seoul 01795, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040489']
2576,33212907,PROFAST: A Randomized Trial Assessing the Effects of Intermittent Fasting and  Lacticaseibacillus rhamnosus  Probiotic among People with Prediabetes.,"Both intermittent fasting and specific probiotics have shown promise in improving glucose tolerance with a potential for synergistic effects through alterations to gut microbiota. In this randomized, double-blinded, two-arm feasibility study, we investigated whether intermittent fasting, supplemented with  Lacticaseibacillus rhamnosus  HN001 probiotic, reduces HbA1c in individuals with prediabetes. All participants with HbA1c 40-50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600-650 kcal/day) and were randomized 1:1 to either daily probiotic ( Lacticaseibacillus rhamnosus  HN001) or placebo for 12 weeks. The primary outcome was a change in HbA1c. Secondary outcomes included changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior. Of 33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m 2 ) completed the intervention ( n  = 11 placebo,  n  = 15 probiotic). HbA1c decreased from 43 ± 2.7 mmol/mol to 41 ± 2.3 mmol/mol,  p  < 0.001, with average of 5% weight loss. No significant between-group differences were seen in primary or secondary outcomes except for social functioning ( p  = 0.050) and mental health ( p  = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group. This study shows additional psychological benefits of probiotic supplementation during intermittent fasting to achieve weight loss and glycemic improvement in prediabetes.",2020,"No significant between-group differences were seen in primary or secondary outcomes except for social functioning ( p  = 0.050) and mental health ( p  = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group.","['All participants with HbA1c 40-50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600-650 kcal/day', 'prediabetes', 'individuals with prediabetes', '33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m 2 ) completed the intervention ( n  = 11 placebo,  n  = 15 probiotic', 'People with Prediabetes']","['PROFAST', 'placebo', 'probiotic supplementation', 'Intermittent Fasting and  Lacticaseibacillus rhamnosus  Probiotic', 'daily probiotic ( Lacticaseibacillus rhamnosus  HN001) or placebo', 'intermittent fasting, supplemented with  Lacticaseibacillus rhamnosus']","['changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior', 'mental health', 'change in HbA1c', 'social functioning', 'weight loss and glycemic improvement']","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0381011', 'cui_str': 'ProFast'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",26.0,0.551726,"No significant between-group differences were seen in primary or secondary outcomes except for social functioning ( p  = 0.050) and mental health ( p  = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group.","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tay', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pringle', 'Affiliation': 'Discipline of Nutrition & Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Penning', 'Affiliation': 'Discipline of Nutrition & Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Plank', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland 1142, New Zealand.'}]",Nutrients,['10.3390/nu12113530']
2577,33212981,Clinical and Microbiological Efficacy of Pyrophosphate Containing Toothpaste: A Double-Blinded Placebo-Controlled Randomized Clinical Trial.,"(1) Background: Dental calculus works as a niche wherein pathogenic bacteria proliferate in the oral cavity. Previous studies revealed the anticalculus activity of pyrophosphates, however there was no clinical study that evaluated microbiome changes associated with calculus inhibition. Therefore, the aim of this randomized clinical trial was to evaluate the calculus inhibition of pyrophosphate-containing toothpaste and its effect on oral microbiome changes. (2) Methods: Eighty subjects with a calculus index ≥2 on the lingual of the mandibular anterior tooth were randomly allocated to the test group that pyrophosphate-containing toothpaste was given to or the placebo control group. Full mouth debridement and standardized tooth brushing instruction were given before the allocation. Plaque index, gingival index, calculus index, probing depth, and bleeding on probing were measured at the baseline, and at 4, 8 and 12 weeks. Genomic DNA was extracted from the plaque samples collected at the baseline and at 12 weeks, and 16S ribosomal RNA gene amplicon sequencing was applied for microbiome analysis. (3) Results: None of the clinical parameters showed significant differences by visits or groups, except the plaque index of the test group, which reduced significantly between 4 and 12 weeks. A significant difference of microbiome between the baseline and 12 weeks was observed in the test group. Between baseline and 12 weeks, the proportion of  Spirochetes  decreased in the control group, and the proportions of  Proteobacteria ,  Fusobacteria  and  Spirochetes  in the phylum level and the proportions of  Haemophilus ,  Fusobacterium  and  Capnocytophaga  in the genus level decreased in the test group. In the test group, as plaque index decreased,  Streptococcus  increased, and  Fusobacterium  and  Haemophilus parainfluenza  decreased. (4) Conclusion: The use of pyrophosphate-containing toothpaste effectively inhibited the dysbiosis of the oral microbiome and the proliferation of pathogenic species in periodontal disease. Clinically, plaque formation in the pyrophosphate-containing toothpaste group was effectively decreased, however there was no significant change in calculus deposition.",2020,"In the test group, as plaque index decreased,  Streptococcus  increased, and  Fusobacterium  and  Haemophilus parainfluenza  decreased.",['Eighty subjects with a calculus index ≥2 on the lingual of the mandibular anterior tooth'],"['pyrophosphate-containing toothpaste', 'Pyrophosphate Containing Toothpaste', 'Placebo', 'placebo control group']","['calculus deposition', 'proportion of  Spirochetes', 'plaque index', 'microbiome', 'plaque formation', 'proportions of  Proteobacteria ,  Fusobacteria  and  Spirochetes', 'Plaque index, gingival index, calculus index, probing depth, and bleeding on probing', 'plaque index decreased,  Streptococcus  increased, and  Fusobacterium  and  Haemophilus parainfluenza']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0034320', 'cui_str': 'Pyrophosphate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0037973', 'cui_str': 'Order Spirochaetales'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C1003893', 'cui_str': 'Fusobacteria'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016878', 'cui_str': 'Fusobacterium'}, {'cui': 'C0018479', 'cui_str': 'Haemophilus'}, {'cui': 'C0030389', 'cui_str': 'Parainfluenza'}]",80.0,0.120283,"In the test group, as plaque index decreased,  Streptococcus  increased, and  Fusobacterium  and  Haemophilus parainfluenza  decreased.","[{'ForeName': 'Inpyo', 'Initials': 'I', 'LastName': 'Hong', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}, {'ForeName': 'Hyun Gee', 'Initials': 'HG', 'LastName': 'Lee', 'Affiliation': 'Safety and Microbiology Lab, Amorepacific R&D Safety and Microbiology Lab, Amorepacific Corporation R&D Center, Yongin 17074, Korea.'}, {'ForeName': 'Hye Lim', 'Initials': 'HL', 'LastName': 'Keum', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Myong Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}, {'ForeName': 'Ui-Won', 'Initials': 'UW', 'LastName': 'Jung', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}, {'ForeName': 'KiJung', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Su Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Taehun', 'Initials': 'T', 'LastName': 'Park', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Jin Ju', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Woo Jun', 'Initials': 'WJ', 'LastName': 'Sul', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Susun', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Safety and Microbiology Lab, Amorepacific R&D Safety and Microbiology Lab, Amorepacific Corporation R&D Center, Yongin 17074, Korea.'}, {'ForeName': 'Jae-Kook', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}]",Microorganisms,['10.3390/microorganisms8111806']
2578,33213012,Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial.,"This study aimed to evaluate the efficacy of pitavastatin pretreatment on contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) after a coronary procedure. This was a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial. All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m 2 ) were enrolled and randomized into two groups. Group I consisted of patients who were treated with statins (pitavastatin 4 mg/day) for seven days before and three days after the procedure ( n  = 37, 52.9%), and group II consisted of patients who were treated with a placebo ( n  = 33, 47.1%). The primary endpoint was the incidence of CIN, and the secondary endpoints were the change in serum creatinine (∆sCr) level and estimated glomerular filtration rate (∆eGFR) after the procedure. The mean age of the patients (males, 74%) was 70.4 ± 9.0 years. After the coronary procedure, the incidence of CIN was lower in group I than in group II, but the difference was not significant (5.4% vs. 9.1%,  p  = 0.661). The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group I than in group II, but the difference was not significant (-0.11 ± 0.53 mg/dL and -0.04 ± 0.33 mg/dL,  p  = 0.678; 4.3 ± 11.2 mL/min/1.73 m 2  and -2.9 ± 20.4 mL/min/1.73 m 2 ,  p  = 0.161, respectively). This study showed the possibility of a clinical benefit of pretreatment with a high dose of pitavastatin for the prevention of CIN in patients with CKD after coronary procedure (ClinicalTrials.gov Identifier: NCT01871792).",2020,The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group,"['Patients with Renal Dysfunction Undergoing Coronary Procedure', 'patients with CKD after coronary procedure (ClinicalTrials.gov Identifier', 'The mean age of the patients (males, 74%) was 70.4 ± 9.0 years', 'All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m 2 ', 'patients with chronic kidney disease (CKD) after a coronary procedure']","['pitavastatin', 'Pitavastatin', 'placebo', 'statins (pitavastatin']","['incidence of CIN', 'maximal ∆eGFR', 'change in serum creatinine (∆sCr) level and estimated glomerular filtration rate (∆eGFR', 'maximal ∆sCr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",70.0,0.15508,The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group,"[{'ForeName': 'Woong Chol', 'Initials': 'WC', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon 21565, Korea.'}, {'ForeName': 'Minsu', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon 24253, Korea.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul 01830, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Byoung-Kwon', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Hyuck Moon', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9113689']
2579,33213284,Impaired postprandial glucose and no improvement in other cardiometabolic responses or cognitive function by breaking up sitting with bodyweight resistance exercises: a randomised crossover trial.,"The effects of breaking up sitting with resistance exercise on cardiometabolic health and cognitive function in young healthy adults are unknown. This study evaluated the acute effects of breaking up sitting with bodyweight resistance exercise on postprandial glucose, lipids, blood pressure and cognitive function. A randomised crossover design was used. Twelve normal-weight participants aged 25 ± 6 years took part in two, 5 h conditions: (1) uninterrupted sitting (SIT), and (2) sitting with 3 min of bodyweight resistance exercise breaks every 30 min (REX). Dietary intake was standardised across conditions. Linear mixed models were used to compare outcomes between conditions. Postprandial glucose was significantly higher in the REX condition than in SIT (incremental area under the curve 346.3 [95% confidence interval: 233.9, 458.7] and 256.9 [144.4, 369.3] mmol/L∙5 h, respectively, p = 0.045). Blood pressure, lipids and cognitive function outcomes were not different between conditions (p ≥ 0.05). This study suggests that breaking up sitting with bodyweight resistance exercise does not benefit cardiometabolic health or cognitive function acutely in young healthy adults. The longer-term effects of breaking up sitting with resistance exercise warrants investigation to appropriately inform public health guidelines.",2020,"Postprandial glucose was significantly higher in the REX condition than in SIT (incremental area under the curve 346.3 [95% confidence interval: 233.9, 458.7] and 256.9 [144.4, 369.3] mmol/L∙5 h, respectively, p = 0.045).","['young healthy adults', 'Twelve normal-weight participants aged 25\xa0±\xa06\xa0years took part in two, 5\xa0h conditions: (1']","['breaking up sitting with resistance exercise', 'breaking up sitting with bodyweight resistance exercise', 'uninterrupted sitting (SIT), and (2) sitting with 3\xa0min of bodyweight resistance exercise breaks every 30\xa0min (REX']","['Postprandial glucose', 'postprandial glucose, lipids, blood pressure and cognitive function', 'cardiometabolic health and cognitive function', 'Blood pressure, lipids and cognitive function outcomes', 'cardiometabolic responses or cognitive function', 'Impaired postprandial glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0336419,"Postprandial glucose was significantly higher in the REX condition than in SIT (incremental area under the curve 346.3 [95% confidence interval: 233.9, 458.7] and 256.9 [144.4, 369.3] mmol/L∙5 h, respectively, p = 0.045).","[{'ForeName': 'Opie P', 'Initials': 'OP', 'LastName': 'Charlett', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire , Bedford, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Morari', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire , Bedford, UK.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Bailey', 'Affiliation': 'Institute for Sport and Physical Activity Research, School of Sport Science and Physical Activity, University of Bedfordshire , Bedford, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1847478']
2580,33213378,Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial.,"BACKGROUND


To determine the safety and efficacy of different doses of tolvaptan for treating Chinese cirrhotic patients with or without hyponatraemia who still had ascites after routine therapy with diuretics.
METHODS


In the present placebo-controlled, randomized, double-blinded, multicentre clinical trial, patients with cirrhotic ascites who failed to adequately respond to a combination of an aldosterone antagonist plus an orally administered loop diuretic were randomly placed at a 4:2:1 ratio into 3 groups [the 15 mg/day tolvaptan group (N = 301), 7.5 mg/day tolvaptan group (N = 153) and placebo group (N = 76)] for 7 days of treatment. The effects and safety were evaluated on days 4 and 7. A change in body weight from baseline on day 7 of treatment was the primary endpoint.
RESULTS


The administration of 7.5 or 15 mg/day tolvaptan significantly decreased body weight from baseline on day 7 of treatment compared to that with placebo treatment (P = 0.026; P = 0.001). For the secondary endpoints, changes in abdominal circumference from baseline and improvements in ascites were markedly different in the treatment groups and the placebo group on day 7 (P 7.5  = 0.05, P 15.0  = 0.002 and P 7.5  = 0.037, P 15.0  = 0.003), but there was no difference between the 7.5 mg/day and 15 mg/day dosage groups. The 24-h cumulative urine volume was higher in the 7.5 mg/day and 15 mg/day tolvaptan groups than the placebo group (P = 0.002, P < 0.001) and was greater in the 15 mg/day tolvaptan group than the 7.5 mg/day tolvaptan group (P = 0.004). Sodium serum concentrations were higher in patients with hyponatraemia after tolvaptan treatment, with no significant difference between the two dosage groups. The incidence of serious adverse drug reactions was not different between the groups (P = 0.543).
CONCLUSIONS


Tolvaptan treatment at 7.5 mg per day might be a good therapeutic choice for Chinese cirrhotic patients with ascites who did not achieve satisfactory clinical responses to previous treatment regimens with combination therapy with an aldosterone antagonist and an orally administered loop diuretic.
TRIAL REGISTRATION


NCT01349348. Retrospectively registered May 2011.",2020,"The incidence of serious adverse drug reactions was not different between the groups (P = 0.543).
","['Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses', 'patients with cirrhotic ascites who failed to adequately respond to a combination of an', 'Chinese cirrhotic patients with or without hyponatraemia who still had ascites after routine therapy with diuretics', 'Chinese cirrhotic patients with ascites']","['aldosterone antagonist', 'placebo', 'tolvaptan', 'Tolvaptan therapy', 'aldosterone antagonist plus an orally administered loop diuretic', 'tolvaptan group (N\u2009=\u2009301), 7.5\xa0mg/day tolvaptan']","['abdominal circumference from baseline and improvements in ascites', 'safety and efficacy', 'body weight', '24-h cumulative urine volume', 'Sodium serum concentrations', 'incidence of serious adverse drug reactions']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1319171', 'cui_str': 'Medication response'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",,0.191226,"The incidence of serious adverse drug reactions was not different between the groups (P = 0.543).
","[{'ForeName': 'Jieting', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': 'Tianjin Third Hospital, Tianjin, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Southwest Hospital, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huiguo', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Beijing Youan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': 'Henan Provincial Peoples Hospital, Zhengzhou, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center, Shanghai, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': '85 Hospital of Peoples Liberation Army, Shanghai, China.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Nonghua', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Yueqiu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Shanghai Shuguang Hospital, Shanghai, China.'}, {'ForeName': 'Zhenghua', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Yingxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Minde', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'School of Medicine Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, No. 145, Middle Shandong Road, Shanghai, 200001, China. 13003175438@163.com.'}]",BMC gastroenterology,['10.1186/s12876-020-01536-0']
2581,33213398,Development and evaluation of an eHealth self-management intervention for patients with chronic kidney disease in China: protocol for a mixed-method hybrid type 2 trial.,"BACKGROUND


Chronic kidney disease (CKD) is a significant public health concern. In patients with CKD, interventions that support disease self-management have shown to improve health status and quality of life. At the moment, the use of electronic health (eHealth) technology in self-management interventions is becoming more and more popular. Evidence suggests that eHealth-based self-management interventions can improve health-related outcomes of patients with CKD. However, knowledge of the implementation and effectiveness of such interventions in general, and in China in specific, is still limited. This study protocol aims to develop and tailor the evidence-based Dutch 'Medical Dashboard' eHealth self-management intervention for patients suffering from CKD in China and evaluate its implementation process and effectiveness.
METHODS


To develop and tailor a Medical Dashboard intervention for the Chinese context, we will use an Intervention Mapping (IM) approach. A literature review and mixed-method study will first be conducted to examine the needs, beliefs, perceptions of patients with CKD and care providers towards disease (self-management) and eHealth (self-management) interventions (IM step 1). Based on the results of step 1, we will specify outcomes, performance objectives, and determinants, select theory-based methods and practical strategies. Knowledge obtained from prior results and insights from stakeholders will be combined to tailor the core interventions components of the 'Medical Dashboard' self-management intervention to the Chinese context (IM step 2-5). Then, an intervention and implementation plan will be developed. Finally, a 9-month hybrid type 2 trial design will be employed to investigate the effectiveness of the intervention using a cluster randomized controlled trial with two parallel arms, and the implementation integrity (fidelity) and determinants of implementation (IM step 6).
DISCUSSION


Our study will result in the delivery of a culturally tailored, standardized eHealth self-management intervention for patients with CKD in China, which has the potential to optimize patients' self-management skills and improve health status and quality of life. Moreover, it will inform future research on the tailoring and translation of evidence-based eHealth self-management interventions in various contexts.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04212923 ; Registered December 30, 2019.",2020,Evidence suggests that eHealth-based self-management interventions can improve health-related outcomes of patients with CKD.,"['patients with CKD in China', 'Chronic kidney disease (CKD', 'patients with chronic kidney disease in China', 'patients with CKD', 'patients suffering from CKD in China', 'patients with CKD and care providers towards disease (self-management) and eHealth (self-management) interventions (IM step 1']",['eHealth self-management intervention'],['health status and quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0739368,Evidence suggests that eHealth-based self-management interventions can improve health-related outcomes of patients with CKD.,"[{'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, Netherlands. H.Shen@lumc.nl.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'van der Kleij', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Paul J M', 'Initials': 'PJM', 'LastName': 'van der Boog', 'Affiliation': 'Department of Nephrology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Wenjiao', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Lou', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Zhengzhou University, Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Chavannes', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Centre, Leiden, Netherlands.'}]",BMC nephrology,['10.1186/s12882-020-02160-6']
2582,33213400,Effectiveness of a guided ACT-based self-help resilience training for depressive symptoms during pregnancy: Study protocol of a randomized controlled trial embedded in a prospective cohort.,"BACKGROUND


During pregnancy, about 10 to 20% of women experience depressive symptoms. Subclinical depression increases the risk of peripartum depression, maternal neuro-endocrine dysregulations, and adverse birth and infant outcomes. Current treatments often comprise face-to-face psychological or pharmacological treatments that may be too intensive for women with subclinical depression leading to drop-out and moderate effectiveness. Therefore, easily accessible, resilience enhancing and less stigmatizing interventions are needed to prevent the development of clinical depression. This paper describes the protocol of a prospective cohort study with an embedded randomized controlled trial (RCT) that aims to improve mental resilience in a sample of pregnant women through a self-help program based on the principles of Acceptance and Commitment Therapy (ACT). Maternal and offspring correlates of the trajectories of peripartum depressive symptoms will also be studied.
METHODS


Pregnant women (≥ 18 years) receiving care in Dutch midwifery practices will participate in a prospective cohort study (n ~ 3500). Between 12 and 18 weeks of pregnancy, all women will be screened for depression with the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS score ≥ 11 will be evaluated with a structured clinical interview. Participants with subclinical depression (n = 290) will be randomized to a 9-week guided self-help ACT-training or to care as usual (CAU). Primary outcomes (depressive symptoms and resilience) and secondary outcomes (e.g. anxiety and PTSD, bonding, infant development) will be collected via online questionnaires at four prospective assessments around 20 weeks and 30 weeks gestation and at 6 weeks and 4 months postpartum. Maternal hair cortisol concentrations will be assessed in a subsample of women with a range of depressive symptoms (n = 300). The intervention's feasibility will be assessed through qualitative interviews in a subsample of participants (n = 20).
DISCUSSION


This is the first study to assess the effectiveness of an easy to administer intervention strategy to prevent adverse mental health effects through enhancing resilience in pregnant women with antepartum depressive symptomatology. This longitudinal study will provide insights into trajectories of peripartum depressive symptoms in relation to resilience, maternal cortisol, psychological outcomes, and infant developmental milestones.
TRIAL REGISTRATION


Netherlands Trial Register (NTR), NL7499 . Registered 5 February 2019.",2020,This is the first study to assess the effectiveness of an easy to administer intervention strategy to prevent adverse mental health effects through enhancing resilience in pregnant women with antepartum depressive symptomatology.,"['depressive symptoms during pregnancy', 'pregnant women with antepartum depressive symptomatology', 'Participants with subclinical depression (n\u2009=\u2009290', 'subsample of participants (n\u2009=\u200920', 'pregnant women through a self-help program based on the principles of Acceptance and Commitment Therapy (ACT', 'Pregnant women (≥', 'subsample of women with a range of depressive symptoms (n\u2009=\u2009300', 'Women with an EPDS score\u2009≥\u200911 will be evaluated with a structured clinical interview']","['9-week guided self-help ACT-training or to care as usual (CAU', 'guided ACT-based self-help resilience training']","['Maternal hair cortisol concentrations', 'risk of peripartum depression, maternal neuro-endocrine dysregulations, and adverse birth and infant outcomes', 'Primary outcomes (depressive symptoms and resilience) and secondary outcomes (e.g. anxiety and PTSD, bonding, infant development) will be collected via online questionnaires', 'depression with the Edinburgh Postnatal Depression Scale (EPDS', 'mental resilience']","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0199182', 'cui_str': 'History taking'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2936491', 'cui_str': 'Peripartum period'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}]",,0.237503,This is the first study to assess the effectiveness of an easy to administer intervention strategy to prevent adverse mental health effects through enhancing resilience in pregnant women with antepartum depressive symptomatology.,"[{'ForeName': 'Anke B', 'Initials': 'AB', 'LastName': 'Witteveen', 'Affiliation': 'Department of Midwifery Science, AVAG/Amsterdam Public Health Research Institute, Amsterdam UMC, location VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. a.witteveen@amsterdamumc.nl.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Henrichs', 'Affiliation': 'Department of Midwifery Science, AVAG/Amsterdam Public Health Research Institute, Amsterdam UMC, location VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Annika L', 'Initials': 'AL', 'LastName': 'Walker', 'Affiliation': 'Department of Midwifery Science, AVAG/Amsterdam Public Health Research Institute, Amsterdam UMC, location VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Department of Psychology, Health and Technology , University of Twente , Drienerlolaan 5, 7522 NB, Enschede, Netherlands.'}, {'ForeName': 'Huibert', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, Hanzeplein 1, Groningen, 9713GZ, Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Fontein-Kuipers', 'Affiliation': 'Institute for Healthcare - School of Midwifery , Rotterdam University of Applied Sciences , Rochussenstraat 198, 3015 EK, Rotterdam, Netherlands.'}, {'ForeName': 'Francois G', 'Initials': 'FG', 'LastName': 'Schellevis', 'Affiliation': 'Department of General Practice , Amsterdam UMC Vrije Universiteit Amsterdam Amsterdam Public Health Research Institute , Van der Boechorststraat 7, 1081 BT, Amsterdam, Netherlands.'}, {'ForeName': 'Claire A I', 'Initials': 'CAI', 'LastName': 'Stramrood', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Oosterpark 9, 1091 AC, Amsterdam, Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Olff', 'Affiliation': 'Department of Psychiatry UMC, location AMC, Meibergdreef 9, 1105 AZ, Amsterdam, Netherlands.'}, {'ForeName': 'Corine J', 'Initials': 'CJ', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Midwifery Science, AVAG/Amsterdam Public Health Research Institute, Amsterdam UMC, location VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Ank', 'Initials': 'A', 'LastName': 'de Jonge', 'Affiliation': 'Department of Midwifery Science, AVAG/Amsterdam Public Health Research Institute, Amsterdam UMC, location VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03395-9']
2583,33213514,Effect on autonomic nervous activity of applying hot towels for 10 s to the back during bed baths.,"BACKGROUND


Bed baths are a daily nursing activity to maintain patients' hygiene. Those may provide not only comfort but also relaxation. Notably, applying a hot towel to the skin for 10 s (AHT10s) during bed baths helped to reduce the risk of skin tears and provided comfort and warmth in previous studies. However, it is still unclear whether autonomic nervous system is affected by bed baths. Thus, this study investigated the effect on the autonomic nervous activity of applying hot towels for 10 s to the back during bed baths.
METHODS


This crossover study had 50 participants (25 men and women each; average age 22.2 ± 1.6 years; average body mass index 21.4 ± 2.2 kg/m 2 ) who took bed baths with and without (control condition: CON) AHT10s on their back. Skin temperature, heart rate variability (HRV), and blood pressure (BP) were measured. Subjective evaluations and the State-Trait Anxiety Inventory in Japanese were also performed.
RESULTS


A significant interaction of time and bed bath type on skin surface temperature was observed (p < .001). Regarding the means of skin surface temperature at each measurement time point, those for AHT10s were significantly higher than those for CON. Although the total state-anxiety score significantly decreased in both the bed bath types after intervention, the mean values of comfort and warmth were higher for bed baths with AHT10s than for CON (p < .05) during bed baths; AHT10s was significantly higher in warmth than CON after 15 min (p = .032). The interaction and main effects of time on HRV and BP and that of bed bath type were not significant.
CONCLUSION


Bed baths that involved AHT10s caused participants to maintain a higher skin temperature and warmer feeling than under the wiping-only condition; they also provided comfort during the interventions. However, the bed baths with AHT10s did not allow participants to reach a relaxed state; moreover, there was no change in autonomic nerve activity. This may be due to participants' increased anxiety from skin exposure and the intervention being limited to one part of the body.",2020,"Although the total state-anxiety score significantly decreased in both the bed bath types after intervention, the mean values of comfort and warmth were higher for bed baths with AHT10s than for CON (p < .05) during bed baths; AHT10s was significantly higher in warmth than CON after 15 min (p = .032).",['50 participants (25 men and women each; average age 22.2 ± 1.6 years; average body mass index 21.4 ± 2.2 kg/m 2 ) who took bed baths with and without (control condition: CON) AHT10s on their back'],[],"['Subjective evaluations and the State-Trait Anxiety Inventory', 'HRV and BP', 'autonomic nerve activity', 'autonomic nervous activity', 'skin surface temperature', 'Skin temperature, heart rate variability (HRV), and blood pressure (BP', 'total state-anxiety score', 'skin temperature and warmer feeling', 'mean values of comfort and warmth']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0004600', 'cui_str': 'Back'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206250', 'cui_str': 'Autonomic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0232426,"Although the total state-anxiety score significantly decreased in both the bed bath types after intervention, the mean values of comfort and warmth were higher for bed baths with AHT10s than for CON (p < .05) during bed baths; AHT10s was significantly higher in warmth than CON after 15 min (p = .032).","[{'ForeName': 'Inaho', 'Initials': 'I', 'LastName': 'Shishido', 'Affiliation': 'Graduate School of Health Sciences, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Konya', 'Affiliation': 'Graduate School of Health Sciences, Hokkaido University, Hokkaido, Japan.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Yano', 'Affiliation': 'Faculty of Health Sciences, Hokkaido University, Hokkaido, Japan. r-yano@med.hokudai.ac.jp.'}]",Journal of physiological anthropology,['10.1186/s40101-020-00245-7']
2584,33213527,Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: a single-dose and two-period crossover randomized study.,"BACKGROUND


Levamlodipine, a calcium channel blocker, has been show act as a cardiovascular drug. To compare the pharmacokinetic parameters between levamlodipine (test formulation) at a single dose of 5 mg and amlodipine (reference formulation) at a single dose of 10 mg, the bioequivalence study was carried out.
METHODS


A single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasted and fed groups equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 h later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine the plasma concentrations of levamlodipine. Adverse events were recorded.
RESULTS


The 90% confidence intervals (CIs) of the ratio of geometric means (GMRs) of C max , AUC 0-t , and AUC 0-∞  under both fasted and fed conditions were within the prespecified bioequivalence limits between 80 ~ 125%. Under fasted conditions, 24 subjects were enrolled and completed the study. The mean C max  was (2.70 ± 0.49) ng/mL, AUC 0-t  was (141.32 ± 36.24) ng × h/mL and AUC 0-∞  was (157.14 ± 45.65) ng × h/mL after a single dose of 5 mg levamlodipine. The mean C max  was (2.83 ± 0.52) ng/mL, AUC 0-t  was (153.62 ± 33.96) ng × h/mL and AUC 0-∞  was (173.05 ± 41.78) ng × h/mL after a single dose of 10 mg amlodipine. Under fed conditions, 24 subjects were enrolled and completed the study. The mean C max  was (2.73 ± 0.55) ng/mL, AUC 0-t  was (166.93 ± 49.96) ng × h/mL and AUC 0-∞  was (190.99 ± 70.89) ng × h/mL after a single dose of 5 mg levamlodipine. The mean C max  was (2.87 ± 0.81) ng/mL AUC 0-t  was (165.46 ± 43.58) ng × h/mL and AUC 0-∞  was (189.51 ± 64.70) ng × h/mL after a single dose of 10 mg amlodipine. Serious adverse event was not observed.
CONCLUSION


The trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasted condition and fed condition.
TRIAL REGISTRATION


Cinicaltrials, NCT04411875 . Registered 3 June 2020 - Retrospectively registered.",2020,"Serious adverse event was not observed.
","['Under fasted conditions, 24 subjects were enrolled and completed the study', '48 subjects', 'healthy Chinese subjects', '24 subjects were enrolled and completed the study']","['levamlodipine', 'Levamlodipine', 'levamlodipine besylate tablets', 'amlodipine', 'mL']","['blood samples', 'Adverse events', 'mean C max', 'confidence intervals (CIs) of the ratio of geometric means (GMRs) of C max , AUC 0-t , and AUC 0-∞  under both fasted and fed conditions']","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C2717539', 'cui_str': 'levamlodipine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",24.0,0.133659,"Serious adverse event was not observed.
","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Chenjing', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Xiaomeng', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Phase I Clinical Research Center, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China. caoyu1767@126.com.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00459-6']
2585,33213529,Zilucoplan in patients with acute hypoxic respiratory failure due to COVID-19 (ZILU-COV): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


Zilucoplan (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms that lead to improvement in lung oxygenation parameters. The purpose of this study is to investigate the efficacy and safety of Zilucoplan in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure.
TRIAL DESIGN


This is a phase 2 academic, prospective, 2:1 randomized, open-label, multi-center interventional study.
PARTICIPANTS


Adult patients (≥18y old) will be recruited at specialized COVID-19 units and ICUs at 9 Belgian hospitals. The main eligibility criteria are as follows: 1) Inclusion criteria: a. Recent (≥6 days and ≤16 days) SARS-CoV-2 infection. b. Chest CT scan showing bilateral infiltrates within the last 2 days prior to randomisation. c. Acute hypoxia (defined as PaO 2 /FiO 2  below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen). d. Signs of cytokine release syndrome characterized by either high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those. 2) Exclusion criteria: e. Mechanical ventilation for more than 24 hours prior to randomisation. f. Active bacterial or fungal infection. g. History of meningococcal disease (due to the known high predisposition to invasive, often recurrent meningococcal infections of individuals deficient in components of the alternative and terminal complement pathways).
INTERVENTION AND COMPARATOR


Patients in the experimental arm will receive daily 32,4 mg Zilucoplan subcutaneously and a daily IV infusion of 2g of the antibiotic ceftriaxone for 14 days (or until hospital discharge, whichever comes first) in addition to standard of care. These patients will receive additional prophylactic antibiotics until 14 days after the last Zilucoplan dose: hospitalized patients will receive a daily IV infusion of 2g of ceftriaxone, discharged patients will switch to daily 500 mg of oral ciprofloxacin. The control group will receive standard of care and a daily IV infusion of 2g of ceftriaxone for 1 week (or until hospital discharge, whichever comes first), to control for the effects of antibiotics on the clinical course of COVID-19.
MAIN OUTCOMES


The primary endpoint is the improvement of oxygenation as measured by mean and/or median change from pre-treatment (day 1) to post-treatment (day 6 and 15 or at discharge, whichever comes first) in PaO 2 /FiO 2  ratio, P(A-a)O 2  gradient and a/A PO 2  ratio. (PAO 2 = Partial alveolar pressure of oxygen, PaO 2 =partial arterial pressure of oxygen, FiO 2 =Fraction of inspired oxygen).
RANDOMISATION


Patients will be randomized in a 2:1 ratio (Zilucoplan: control). Randomization will be done using an Interactive Web Response System (REDCap).
BLINDING (MASKING)


In this open-label trial neither participants, caregivers, nor those assessing the outcomes will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


A total of 81 patients will be enrolled: 54 patients will be randomized to the experimental arm and 27 patients to the control arm.
TRIAL STATUS


ZILU-COV protocol Version 4.0 (June 10 2020). Participant recruitment started on June 23 2020 and is ongoing. Given the uncertainty of the pandemic, it is difficult to predict the anticipated end date.
TRIAL REGISTRATION


The trial was registered on Clinical Trials.gov on May 11 th , 2020 (ClinicalTrials.gov Identifier: NCT04382755 ) and on EudraCT (Identifier: 2020-002130-33 ).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"OBJECTIVES


Zilucoplan (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms that lead to improvement in lung oxygenation parameters.","['COVID-19 patients with acute hypoxic respiratory failure', 'patients with acute hypoxic respiratory failure due to COVID-19 (ZILU-COV', 'Adult patients (≥18y old) will be recruited at specialized COVID-19 units and ICUs at 9 Belgian hospitals', '81 patients will be enrolled: 54 patients']","['Mechanical ventilation', 'Zilucoplan', 'Zilucoplan subcutaneously and', 'antibiotic ceftriaxone', 'ceftriaxone, discharged patients will switch to daily 500 mg of oral ciprofloxacin', 'Chest CT scan', 'Zilucoplan (complement C5 inhibitor', 'ceftriaxone', 'additional prophylactic antibiotics']","['c. Acute hypoxia', 'efficacy and safety', 'improvement of oxygenation as measured by mean and/or median change', 'PAO 2 = Partial alveolar pressure of oxygen, PaO 2 =partial arterial pressure of oxygen, FiO 2 =Fraction of inspired oxygen']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0009519', 'cui_str': 'Complement component C5'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0232010', 'cui_str': 'Alveolar pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",81.0,0.188073,"OBJECTIVES


Zilucoplan (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms that lead to improvement in lung oxygenation parameters.","[{'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Ans', 'Initials': 'A', 'LastName': 'Vandecauter', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Center for Inflammation Research, Ghent, Belgium.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Lalla', 'Affiliation': ""UCB Biopharma SRL, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Smart', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Detalle', 'Affiliation': ""UCB Biopharma SRL, Braine-l'Alleud, Belgium.""}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Bouw', 'Affiliation': ""UCB Biopharma SRL, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Streffer', 'Affiliation': ""UCB Biopharma SRL, Braine-l'Alleud, Belgium.""}, {'ForeName': 'Thibo', 'Initials': 'T', 'LastName': 'Degeeter', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Vergotte', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Tanguy', 'Initials': 'T', 'LastName': 'Guisez', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Braeckel', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Van Der Straeten', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Bart N', 'Initials': 'BN', 'LastName': 'Lambrecht', 'Affiliation': 'VIB Center for Inflammation Research, Ghent, Belgium and Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium. bart.lambrecht@ugent.be.'}]",Trials,['10.1186/s13063-020-04884-0']
2586,33213530,Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care. This study will also provide an important opportunity to investigate the safety and tolerability of favipiravir, the pharmacokinetic and pharmacodynamic profile of this drug and mechanisms of resistance in the context of COVID-19 infection, as well as the effect of favipiravir on hospitalisation duration and the post COVID-19 health and psycho-social wellbeing of patients recruited to the study.
TRIAL DESIGN


GETAFIX is an open label, parallel group, two arm phase II/III randomised trial with 1:1 treatment allocation ratio. Patients will be randomised to one of two arms and the primary endpoint will assess the superiority of favipiravir plus standard treatment compared to standard treatment alone.
PARTICIPANTS


This trial will recruit adult patients with confirmed positive valid COVID-19 test, who are not pregnant or breastfeeding and have no prior major co-morbidities. This is a multi-centre trial, patients will be recruited from in-patients and outpatients from three Glasgow hospitals: Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary. Patients must meet all of the following criteria: 1. Age 16 or over at time of consent 2. Exhibiting symptoms associated with COVID-19 3. Positive for SARS-CoV-2 on valid COVID-19 test 4. Point 1, 2, 3, or 4 on the WHO COVID-19 ordinal severity scale at time of randomisation. (Asymptomatic with positive valid COVID-19 test, Symptomatic Independent, Symptomatic assistance needed, Hospitalized, with no oxygen therapy) 5. Have >=10% risk of death should they be admitted to hospital as defined by the ISARIC4C risk index: https://isaric4c.net/risk 6. Able to provide written informed consent 7. Negative pregnancy test (women of childbearing potential*) 8. Able to swallow oral medication Patients will be excluded from the trial if they meet any of the following criteria: 1. Renal impairment requiring, or likely to require, dialysis or haemofiltration 2. Pregnant or breastfeeding 3. Of child bearing potential (women), or with female partners of child bearing potential (men) who do not agree to use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment 4. History of hereditary xanthinuria 5. Other patients judged unsuitable by the Principal Investigator or sub-Investigator 6. Known hypersensitivity to favipiravir, its metabolites or any excipients 7. Severe co-morbidities including: patients with severe hepatic impairment, defined as:  • greater than Child-Pugh grade A  • AST or ALT > 5 x ULN  • AST or ALT >3 x ULN and Total Bilirubin > 2xULN 8. More than 96 hours since first positive COVID-19 test sample was taken 9. Unable to discontinue contra-indicated concomitant medications This is a multi-centre trial, patients will be recruited from in-patients and outpatients from three Glasgow hospitals: Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary.
INTERVENTION AND COMPARATOR


Patients randomised to the experimental arm of GETAFIX will receive standard treatment for COVID-19 at the discretion of the treating clinician plus favipiravir. These patients will receive a loading dose of favipiravir on day 1 of 3600mg (1800mg 12 hours apart). On days 2-10, patients in the experimental arm will receive a maintenance dose of favipiravir of 800mg 12 hours apart (total of 18 doses). Patients randomised to the control arm of the GETAFIX trial will receive standard treatment for COVID-19 at the discretion of the treating clinician.
MAIN OUTCOMES


The primary outcome being assessed in the GETAFIX trial is the efficacy of favipiravir in addition to standard treatment in patients with COVID-19 in reducing the severity of disease compared to standard treatment alone. Disease severity will be assessed using WHO COVID 10 point ordinal severity scale at day 15 +/- 48 hours. All randomised participants will be followed up until death or 60 days post-randomisation (whichever is sooner).
RANDOMISATION


Patients will be randomised 1:1 to the experimental versus control arm using computer generated random sequence allocation. A minimisation algorithm incorporating a random component will be used to allocate patients. The factors used in the minimisation will be: site, age (16-50/51-70/71+), history of hypertension or currently obsess (BMI>30 or obesity clinically evident; yes/no), 7 days duration of symptoms (yes/no/unknown), sex (male/female), WHO COVID-19 ordinal severity score at baseline (1/2or 3/4).
BLINDING (MASKING)


No blinding will be used in the GETAFIX trial. Both participants and those assessing outcomes will be aware of treatment allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


In total, 302 patients will be randomised to the GETAFIX trial: 151 to the control arm and 151 to the experimental arm. There will be an optional consent form for patients who may want to contribute to more frequent PK and PD sampling. The maximum number of patients who will undergo this testing will be sixteen, eight males and eight females. This option will be offered to all patients who are being treated in hospital at the time of taking informed consent, however only patients in the experimental arm of the trial will be able to undergo this testing.
TRIAL STATUS


The current GETAFIX protocol is version 4.0 12 th  September 2020. GETAFIX opened to recruitment on 26 th  October 2020 and will recruit patients over a period of approximately six months.
TRIAL REGISTRATION


GETAFIX was registered on the European Union Drug Regulating Authorities Clinical Trials (EudraCT) Database on 15 th  April 2020; Reference number 2020-001904-41 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001904-41/GB ). GETAFIX was registered on ISRCTN on 7 th  September 2020; Reference number ISRCTN31062548 ( https://www.isrctn.com/ISRCTN31062548 ).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (see Additional file 2).",2020,"All randomised participants will be followed up until death or 60 days post-randomisation (whichever is sooner).
","['adults with early stage COVID-19', 'adult patients with confirmed positive valid COVID-19 test, who are not pregnant or breastfeeding and have no prior major co-morbidities', 'patients will be recruited from in-patients and outpatients from three Glasgow hospitals: Royal Alexandra Hospital; Queen Elizabeth University Hospital; and the Glasgow Royal Infirmary', 'GETAFIX was registered on the European Union Drug Regulating Authorities Clinical Trials (EudraCT) Database on 15 th  April 2020; Reference number 2020-001904-41 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001904-41/GB ', ' patients with severe hepatic impairment, defined as: \u2003• greater than Child', 'Of child bearing potential (women), or with female partners of child bearing potential (men) who do not agree to use adequate contraceptive measures for the duration of the study and for 3 months after the completion of study treatment 4', 'patients recruited to the study', 'age (16-50/51-70/71+), history of hypertension or currently obsess (BMI>30 or obesity clinically evident; yes/no), 7 days duration of symptoms (yes/no/unknown), sex (male/female), WHO COVID-19 ordinal severity score at baseline (1/2or 3/4', 'patients who are being treated in hospital at the time of taking informed consent', '302 patients will be randomised to the GETAFIX trial: 151 to the control arm and 151 to the experimental arm', 'patients who have early stage disease', 'Renal impairment requiring, or likely to require, dialysis or haemofiltration 2']","['Glasgow Early Treatment Arm Favirpiravir (GETAFIX', 'favipiravir plus standard treatment compared to standard treatment alone']","['severity of disease', 'Total Bilirubin', 'Severe co-morbidities', 'death', 'efficacy of favipiravir']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}]",302.0,0.186862,"All randomised participants will be followed up until death or 60 days post-randomisation (whichever is sooner).
","[{'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Hanna', 'Affiliation': 'CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Blyth', 'Affiliation': 'NHS Greater Glasgow & Clyde, Glasgow, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Burley', 'Affiliation': 'University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Carmichael', 'Affiliation': 'NHS Greater Glasgow & Clyde, Glasgow, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': 'CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hinsley', 'Affiliation': 'CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Khadra', 'Affiliation': 'University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Department of Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Liz-Anne', 'Initials': 'LA', 'LastName': 'Lewsley', 'Affiliation': 'CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Jones', 'Affiliation': 'CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Taladriz-Sender', 'Affiliation': 'University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Emma C', 'Initials': 'EC', 'LastName': 'Thomson', 'Affiliation': 'MRC-University of Glasgow Centre for Virus Research, Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Scott', 'Affiliation': 'NHS Greater Glasgow & Clyde, Glasgow, UK. janet.scott@glasgow.ac.uk.'}]",Trials,['10.1186/s13063-020-04891-1']
2587,33218266,Immediate shockwave-lithotripsy versus delayed shockwave-lithotripsy after urgent ureteral stenting in patients with ureteral or pyeloureteral urolithiasis: A matched-pair analysis.,"INTRODUCTION


The most common cause of acute renal colic is a ureteral obstruction caused by ureterolithiasis. Urgent intervention is often necessary due to intractable pain. Early extracorporeal shockwave lithotripsy (SWL) as an alternative treatment option to ureteral stenting becomes forgotten in times of rising Ureterorenoscopy. Definitive guidelines are lacking which urgent treatment should be preferred in absence of signs of infection. Therefore, we assessed efficacy and safety of early SWL (eSWL) to secondary SWL (sSWL) after urgent ureteral stenting.
PATIENTS AND METHODS


104 patients treated between 01/2015 and 11/2017 for obstructive ureterolithiasis were matched regarding stone size, stone localization and assigned to group eSWL (n= 52) or group sSWL (n= 52). eSWL group received shock waves (no ureteral stenting) and sSWL group ureteral stenting within 48 hours from diagnosis. Thereafter, patients in group sSWL were treated with shock waves median 23 ± 14.6 days after ureteral stenting. Stone-free rates, complication rates and reintervention rates were assessed. Univariable and multivariable logistic regression was applied to find predictors of outcomes in the two treatment groups.
RESULTS


Overall there was no statistically significant difference between both groups regarding stone-free rate and complication rate. Reinterventions were more often addressed for patients in group sSWL (p= 0.05). eSWL was significantly superior to sSWL regarding stone-free rates for stones between 6-9mm (p= 0.04). At the multivariable multinomial logistic regression none of the two treatment modalities was associated with better outcomes. A body mass index ≥30 was associated with a reduced 6-weeks stone-free status (p= 0.04), whereas stones ≥8 mm were associated with an increased need of reintervention (p= 0.04).
CONCLUSION


eSWL seems to be an effective and safe emergency procedure compared to sSWL after urgent stenting within 6 weeks and should be considered as a treatment option in patients without absolute indications for immediate ureteral drainage.",2020,eSWL was significantly superior to sSWL regarding stone-free rates for stones between 6-9mm (p= 0.04).,"['patients with ureteral or pyeloureteral urolithiasis', 'patients without absolute indications for immediate ureteral drainage', '104 patients treated between 01/2015 and 11/2017 for obstructive ureterolithiasis were matched regarding stone size, stone localization and assigned to group eSWL (n= 52) or group sSWL (n= 52']","['extracorporeal shockwave lithotripsy (SWL', 'shock waves (no ureteral stenting) and sSWL group ureteral stenting', 'Immediate shockwave-lithotripsy versus delayed shockwave-lithotripsy']","['efficacy and safety of early SWL (eSWL) to secondary SWL (sSWL', 'Stone-free rates, complication rates and reintervention rates', 'need of reintervention', 'stone-free rate and complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",104.0,0.0495595,eSWL was significantly superior to sSWL regarding stone-free rates for stones between 6-9mm (p= 0.04).,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Cornelius', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; juliancornelius13@gmail.com.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Zumbühl', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; dominique_87_z@msn.com.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Afferi', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; luca.afferi@luks.ch.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; livio.mordasini@luks.ch.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Bona', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; Carlo.dibona@luks.ch.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Zamboni', 'Affiliation': 'Spedali Civili Hospital, University of Brescia, Department of Urology, Brescia, Italy; stefania.zamboni@libero.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; marco.moschini@luks.ch.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Pozzi', 'Affiliation': 'IRCCS Ospedale San Raffaele, 9372, Division of Experimental Oncology/Unit of Urology; URI, Milano, Lombardia, Italy; edoardopietro.pozzi@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Salonia', 'Affiliation': 'IRCCS Ospedale San Raffaele, 9372, Division of Experimental Oncology/Unit of Urology; URI, Milano, Lombardia, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Mattei', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; agostino.mattei@luks.ch.'}, {'ForeName': 'Hansjörg', 'Initials': 'H', 'LastName': 'Danuser', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; hansjoerg.danuser@luks.ch.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Baumeister', 'Affiliation': 'Luzerner Kantonsspital, 30748, Department of Urology, Luzern, Luzern, Switzerland; philipp.baumeister@luks.ch.'}]",Journal of endourology,['10.1089/end.2020.0384']
2588,33218305,Telehealth-enabled behavioral treatment for problem behaviors in boys with fragile X syndrome: a randomized controlled trial.,"BACKGROUND


Children with fragile X syndrome (FXS) are at increased risk for exhibiting problem behaviors such as aggression and self-injury. However, many children with FXS have limited access to behavioral treatments that have known efficacy due to the low availability of treatment providers and the wide geographical dispersion of families with FXS across the country. Telehealth may offer a cost-effective and practical solution to overcome these significant barriers. We examined the effect of administering an established behavior analytic intervention called functional communication training (FCT) via telehealth on levels of problem behaviors exhibited by boys with FXS. We also examined treatment acceptability, as well as the effect of the treatment on levels of parenting stress.
METHODS


Boys with FXS, aged 3 to 10 years, who displayed problem behaviors daily, were randomized to receive FCT via telehealth (n = 30) or treatment as usual (n = 27) over 12 weeks. Outcome measures included in-session observations of problem behavior, the Aberrant Behavior Checklist-Community (ABC-C), the Treatment Acceptability Rating Form-Revised (TARF-R), and the Parenting Stress Index, 4th edition (PSI-4).
RESULTS


Intention-to-treat analyses indicated that scores on the irritability subscale of the ABC-C, our primary outcome measure, decreased significantly for boys who received FCT via telehealth compared to boys who received treatment as usual (p < .001, Cohen's d = 0.65). In-session observations conducted for those who received treatment showed that levels of problem behavior decreased by 91% from baseline. Levels of parenting stress related to child behavioral problems were also lower following FCT treatment, and caregivers reported that the intervention was acceptable.
CONCLUSIONS


These findings support telehealth-enabled FCT as a framework for expanding access to behavioral treatments for problem behaviors in children with FXS. Expanded delivery of behavior analytic treatment via telehealth also has the potential to lower healthcare costs, improve child and family quality of life, and lead to advances in the treatment of problem behavior in the broader population of individuals with neurodevelopmental disorders.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03510156 . Registered 27 April 2018.",2020,These findings support telehealth-enabled FCT as a framework for expanding access to behavioral treatments for problem behaviors in children with FXS.,"['boys with FXS', 'boys with fragile X syndrome', 'Boys with FXS, aged 3 to 10\u2009years, who displayed problem behaviors daily', 'children with FXS', 'individuals with neurodevelopmental disorders', 'Children with fragile X syndrome (FXS']","['established behavior analytic intervention called functional communication training (FCT) via telehealth', 'Telehealth-enabled behavioral treatment', 'FCT via telehealth']","['session observations of problem behavior, the Aberrant Behavior Checklist-Community (ABC-C), the Treatment Acceptability Rating Form-Revised (TARF-R), and the Parenting Stress Index, 4th edition (PSI-4', 'Levels of parenting stress related to child behavioral problems', 'levels of problem behavior', 'irritability subscale', 'levels of parenting stress']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0016667', 'cui_str': 'Fragile X syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}]","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C4708134', 'cui_str': 'Functional communication training'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}]",,0.132307,These findings support telehealth-enabled FCT as a framework for expanding access to behavioral treatments for problem behaviors in children with FXS.,"[{'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA. hallss@stanford.edu.'}, {'ForeName': 'Katerina D', 'Initials': 'KD', 'LastName': 'Monlux', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Arlette Bujanda', 'Initials': 'AB', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Joy S', 'Initials': 'JS', 'LastName': 'Pollard', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}]",Journal of neurodevelopmental disorders,['10.1186/s11689-020-09331-4']
2589,33218309,Characteristics of resting-state functional connectivity in older adults after the PICMOR intervention program: a preliminary report.,"BACKGROUND


The present study aimed to provide a basis for future research examining the neural mechanisms that underlie the beneficial effect of an intervention program, Photo-Integrated Conversation Moderated by Robots (PICMOR), on verbal fluency in older adults as identified in our previous randomized controlled trial. In this preliminary report, we conducted an additional experiment using resting-state functional magnetic resonance imaging (rsfMRI) after the intervention period. Specifically, we investigated the resting-state functional connectivity (rsFC) characteristics of the intervention group (INT) compared to the control group (CONT).
METHODS


rsfMRI data were acquired from 31 and 30 participants in INT and CONT, respectively, after the intervention. In the analyses, two of the most important regions in verbal fluency, the left inferior and middle frontal gyri, were selected as seed regions, and the rsFCs were compared between groups. We also conducted regression analyses for rsFCs using the difference in individual phonemic verbal fluency task (PVFT) scores between the pre- and post-intervention periods (i.e., post- minus pre-intervention) as an independent variable.
RESULTS


We found higher rsFC in INT than in CONT between the left inferior frontal gyrus as a seed region and the temporal pole and middle frontal gyrus. The rsFC strength between the left inferior frontal gyrus and temporal pole positively correlated with an increased PVFT score between the pre- and post-intervention periods. In contrast, we found lower rsFC in INT than in CONT between the left middle frontal gyrus as a seed region and the posterior cingulate cortex, precuneus, and postcentral gyrus.
CONCLUSIONS


Our findings suggest that the beneficial intervention effect of PICMOR on verbal fluency is characterized by enhanced rsFC of the left inferior frontal gyrus with semantic and executive control-related regions and suppressed rsFC between the left middle frontal gyrus and posterior cortical midline structures. No definitive conclusions can be made because of a lack of rsfMRI data before the intervention. However, this pilot study provides the candidates for rsFCs, reflecting the beneficial effects of PICMOR on the brain network involved in verbal fluency.
TRIAL REGISTRATION


The trial was retrospectively registered at the UMIN Clinical Trials Registry ( UMIN000036667 ) (May 7th, 2019).",2020,We found higher rsFC in INT than in CONT between the left inferior frontal gyrus as a seed region and the temporal pole and middle frontal gyrus.,"['older adults', 'older adults after the PICMOR intervention program', 'rsfMRI data were acquired from 31 and 30 participants in INT and CONT, respectively, after the intervention']","['resting-state functional magnetic resonance imaging (rsfMRI', 'intervention program, Photo-Integrated Conversation Moderated by Robots (PICMOR']","['rsFC strength', 'verbal fluency', 'resting-state functional connectivity (rsFC) characteristics', 'PVFT score', 'verbal fluency, the left inferior and middle frontal gyri', 'individual phonemic verbal fluency task (PVFT) scores']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0440396,We found higher rsFC in INT than in CONT between the left inferior frontal gyrus as a seed region and the temporal pole and middle frontal gyrus.,"[{'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Sugimoto', 'Affiliation': 'RIKEN Center for Advanced Intelligence Project, Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan. hikaru.sugimoto@riken.jp.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Kawagoe', 'Affiliation': 'RIKEN Center for Advanced Intelligence Project, Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan.'}, {'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Otake-Matsuura', 'Affiliation': 'RIKEN Center for Advanced Intelligence Project, Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan.'}]",BMC geriatrics,['10.1186/s12877-020-01892-2']
2590,33213413,A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis.,"BACKGROUND


Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis.
METHODS


A parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation.
RESULTS


Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation.
CONCLUSION


An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.
TRIAL REGISTRATION


The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496 .",2020,"An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible.","['Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation', 'patients receiving haemodialysis', '122 outpatient haemodialysis patients, 94 were assessed as eligible for participation', 'patients receiving maintenance haemodialysis', 'Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent']","['intervention or control group according to their haemodialysis shift', 'arts-based intervention']","['feasibility and acceptability', 'attrition rate', 'mental-wellbeing']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",122.0,0.152912,"An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Carswell', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK. ccarswell02@qub.ac.uk.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Reid', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Walsh', 'Affiliation': ""School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Johnston', 'Affiliation': 'Kidney Care UK, Alton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McAneney', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mullan', 'Affiliation': 'Antrim Area Hospital, Northern Health and Social Care Trust, Antrim, UK.'}, {'ForeName': 'Jenny B', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'College of the Arts, Center for Arts in Medicine, University of Florida, Gainesville, USA.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Nelson', 'Affiliation': 'Northern Health and Social Care Trust, Antrim, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Matthews', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Weatherup', 'Affiliation': 'Northern Health and Social Care Trust, Antrim, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Arts Care Northern Ireland, Belfast, UK.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michelo', 'Affiliation': 'Northern Ireland Kidney Patient Association, Belfast, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Quail', 'Affiliation': 'Arts Care Northern Ireland, Belfast, UK.'}, {'ForeName': 'Grainne', 'Initials': 'G', 'LastName': 'Kielty', 'Affiliation': 'Arts Care Northern Ireland, Belfast, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Mackenzie', 'Affiliation': 'South Eastern Health and Social Care Trust, Renal Unit, Belfast, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Arts Care Northern Ireland, Belfast, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Arbuckle', 'Affiliation': 'Northern Ireland Kidney Patient Association, Belfast, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Noble', 'Affiliation': ""School of Nursing and Midwifery, Queen's University Belfast, Belfast, Northern Ireland, UK.""}]",BMC nephrology,['10.1186/s12882-020-02162-4']
2591,33213440,Comparative evaluation of volumetric changes of three different retrograde calcium silicate materials placed under different pH condititions.,"BACKGROUND


The present study aimed to compare the volumetric changes of three calcium silicate cements after retrofilling and placing under different pH conditions via micro-computed tomography (micro-CT) scan.
METHODS


Forty-two extracted human single-rooted teeth were randomly assigned to three groups according to the retrofilling materials used (Biodentine, Endocem MTA, and ProRoot MTA). Each group was divided into two subgroups according to the setting condition. The teeth in one group were immersed in normal saline for 5 days at room temperature, and the teeth in the other group were immersed in butyric acid (pH = 5.4) for 5 days at room temperature. The volume ratios of the retrofilling material were calculated via micro-CT imaging.
RESULTS


The volume ratios of the Biodentine and Endocem MTA groups were significantly different between the two setting environment, and these groups had significantly lower filled volume ratio (Vf, %) in the acidic environment than in the saline environment (pH = 5.4). Meanwhile, the volume ratio of the ProRoot MTA group did not significantly differ between the two setting environments. All materials under the acidic setting condition had relative radiolucency in the area in contact with the acidic solution.
CONCLUSION


The Vf ratio of the Biodentine and Endocem MTA cements was significantly lower in the acidic environment than in the saline environment. No statistically significant difference was observed in the Vf ratio of ProRoot MTA between the two setting environments.",2020,"The volume ratios of the Biodentine and Endocem MTA groups were significantly different between the two setting environment, and these groups had significantly lower filled volume ratio (Vf, %) in the acidic environment than in the saline environment (pH = 5.4).",['Forty-two extracted human single-rooted teeth'],"['retrofilling materials used (Biodentine, Endocem MTA, and ProRoot MTA']","['volume ratios of the Biodentine', 'volume ratios of the retrofilling material', 'filled volume ratio', 'Vf ratio of ProRoot MTA', 'Vf ratio of the Biodentine and Endocem MTA cements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0449902', 'cui_str': 'Material used'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C3851362', 'cui_str': 'endocem'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C4546581', 'cui_str': 'ProRoot MTA'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C4546581', 'cui_str': 'ProRoot MTA'}, {'cui': 'C3851362', 'cui_str': 'endocem'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}]",42.0,0.025516,"The volume ratios of the Biodentine and Endocem MTA groups were significantly different between the two setting environment, and these groups had significantly lower filled volume ratio (Vf, %) in the acidic environment than in the saline environment (pH = 5.4).","[{'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kwon', 'Affiliation': 'Department of Conservative Dentistry, Wonkwang University Daejeon Dental Hospital, 77 Dunsan-Ro, Seo-Gu, Daejeon, 35233, Republic of Korea.'}, {'ForeName': 'Min-Seock', 'Initials': 'MS', 'LastName': 'Seo', 'Affiliation': 'Department of Conservative Dentistry, Wonkwang University Daejeon Dental Hospital, 77 Dunsan-Ro, Seo-Gu, Daejeon, 35233, Republic of Korea. profee@naver.com.'}]",BMC oral health,['10.1186/s12903-020-01325-x']
2592,33213446,WeChat-based intervention to support breastfeeding for Chinese mothers: protocol of a randomised controlled trial.,"BACKGROUND


Exclusive breastfeeding for the first 6 months of life is the optimal way to feed infants. However, recent studies suggest that exclusive breastfeeding rates in China remain low and are well below the recommended target. There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices. WeChat, the most widely used social networking platform in China, has shown some potential to promote health behaviours. We thus hypothesised that a breastfeeding intervention program delivered via WeChat would achieve at least a 10% increase in exclusive breastfeeding prevalence at 6 months compared to the control group.
METHODS


A two-arm, parallel, multicentre randomised controlled trial of 1000 pregnant women will be conducted at four maternity hospitals of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 28-30 weeks of gestation, and randomly allocated to either the intervention group (participants receive breastfeeding-related information from WeChat) or the control group (participants receive non-breastfeeding information from WeChat) using a central randomisation system on a 1:1 ratio at each participating site. The primary outcomes are exclusive breastfeeding rate and full breastfeeding rate at 6 months postpartum. All randomised participants will be included in the outcome analyses with missing data being imputed based on the best-case and worst-case scenarios. Multilevel mixed regression models will be used in the primary analyses to assess the effectiveness of intervention program on the breastfeeding rates.
DISCUSSION


This trial uses the most widely used social media program as a means of delivering messages to mothers to increase exclusive breastfeeding in China. Increasing exclusive breastfeeding will contribute to meeting the health and environmental goals of the Sustainable Development Guidelines. Trial registration ClinicalTrials.gov, NCT04499404. Registered 5 August 2020-Retrospectively registered, https://clinicaltrials.gov/show/NCT04499404.",2020,"There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices.","['1000 pregnant women will be conducted at four maternity hospitals of Chengdu, China', 'Chinese mothers', 'mothers to increase exclusive breastfeeding in China', 'Eligible women who consent to participate in the trial will be recruited at 28-30\xa0weeks of gestation']","['intervention group (participants receive breastfeeding-related information from WeChat) or the control group (participants receive non-breastfeeding information from WeChat', 'WeChat-based intervention to support breastfeeding']","['exclusive breastfeeding prevalence', 'exclusive breastfeeding rate and full breastfeeding rate at 6 months postpartum']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1171181', 'cui_str': 'Breastfeeding support'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",1000.0,0.115112,"There has been evidence that a lack of awareness of, or exposure to, breastfeeding information is associated with poor breastfeeding practices.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 611731, China.""}, {'ForeName': 'Andy H', 'Initials': 'AH', 'LastName': 'Lee', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Colin W', 'Initials': 'CW', 'LastName': 'Binns', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': ""Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 611731, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Chengdu Jinjiang Maternity and Child Health Hospital, Chengdu, China.'}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 611731, China. cdlcr@163.com.""}]",BMC medical informatics and decision making,['10.1186/s12911-020-01322-8']
2593,33213459,Objective understanding of the Nutri-score front-of-pack label by European consumers and its effect on food choices: an online experimental study.,"BACKGROUND


The effectiveness of Front-of-Pack nutrition Labels (FoPLs) may be influenced by national context. In light of the ongoing efforts to harmonize FoPLs across Europe, this study aimed to compare the effectiveness of five FoPLs (Health Star Rating system, Multiple Traffic Lights, Nutri-Score, Reference Intakes, Warning symbols) on consumer understanding and food choice in 12 European countries.
METHODS


In 2018-2019, for three food categories, approximately 1000 participants per country were asked to select which food they would prefer to purchase between three products with distinct nutritional quality profiles, and then to rank the products by nutritional quality. Participants (N = 12,391 in total) completed these tasks first with no FoPL and then, after randomization to one of the five FoPLs, with a FoPL on the food packages. Associations between FoPLs and change in (i) nutritional quality of food choices and (ii) ability to correctly rank the products by nutritional quality were assessed with logistic regression models adjusted for sociodemographic and lifestyle characteristics of participants, conducted overall and by country.
FINDINGS


Compared with the Reference Intakes, the Nutri-Score (OR = 3.23[2.75-3.81]; p < 0.0001), followed by the Multiple Traffic Lights (OR = 1.68[1.42-1.98]; p < 0.0001), was the most effective FoPL in helping consumers identify the foods' nutritional quality, overall and in each of the 12 countries. Differences between FoPLs regarding food choice modifications were smaller, but the effect of the Nutri-Score seemed slightly higher in eliciting healthier food choices overall compared with the Reference Intakes, followed by the Warning symbols, the Multiple Traffic Lights and the Health Star Rating system.
INTERPRETATION


In the context of FoPL harmonization in Europe, these findings from an online experiment provide insights into the Nutri-Score's effectiveness on European consumers.",2020,"Compared with the Reference Intakes, the Nutri-Score (OR = 3.23[2.75-3.81]; p < 0.0001), followed by the Multiple Traffic Lights (OR = 1.68[1.42-1.98]; p < 0.0001), was the most effective FoPL in helping consumers identify the foods' nutritional quality, overall and in each of the 12 countries.","['Participants (N\u2009', 'In 2018-2019, for three food categories, approximately 1000 participants per country', '12 European countries']","['Front-of-Pack nutrition Labels (FoPLs', 'Nutri-score front-of-pack label']",['FoPLs and change in (i) nutritional quality of food choices and (ii) ability'],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0454713', 'cui_str': 'European country'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0600485,"Compared with the Reference Intakes, the Nutri-Score (OR = 3.23[2.75-3.81]; p < 0.0001), followed by the Multiple Traffic Lights (OR = 1.68[1.42-1.98]; p < 0.0001), was the most effective FoPL in helping consumers identify the foods' nutritional quality, overall and in each of the 12 countries.","[{'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Egnell', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France. m.egnell@eren.smbh.univ-paris13.fr.'}, {'ForeName': 'Zenobia', 'Initials': 'Z', 'LastName': 'Talati', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, 6102, Australia.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Galan', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France.'}, {'ForeName': 'Valentina A', 'Initials': 'VA', 'LastName': 'Andreeva', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Vandevijvere', 'Affiliation': 'Scientific Institute of Public Health (Sciensano), J.Wytsmanstraat 14, 1050, Brussels, Belgium.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Gombaud', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Dréano-Trécant', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Hercberg', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'The George Institute for Global Health, Newtown NSW, Sydney, 2042, Australia.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Julia', 'Affiliation': 'Sorbonne Paris Nord University, Inserm, Inrae, Cnam, Nutritional Epidemiology Research Team (EREN), Epidemiology and Statistics Research Centre -University of Paris (CRESS), Bobigny, 93000, France.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01053-z']
2594,33213541,"Exploration of baseline and early changes in neurocognitive characteristics as predictors of treatment response to bupropion, sertraline, and placebo in the EMBARC clinical trial.","BACKGROUND


Treatment for major depressive disorder (MDD) is imprecise and often involves trial-and-error to determine the most effective approach. To facilitate optimal treatment selection and inform timely adjustment, the current study investigated whether neurocognitive variables could predict an antidepressant response in a treatment-specific manner.
METHODS


In the two-stage Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) trial, outpatients with non-psychotic recurrent MDD were first randomized to an 8-week course of sertraline selective serotonin reuptake inhibitor or placebo. Behavioral measures of reward responsiveness, cognitive control, verbal fluency, psychomotor, and cognitive processing speeds were collected at baseline and week 1. Treatment responders then continued on another 8-week course of the same medication, whereas non-responders to sertraline or placebo were crossed-over under double-blinded conditions to bupropion noradrenaline/dopamine reuptake inhibitor or sertraline, respectively. Hamilton Rating for Depression scores were also assessed at baseline, weeks 8, and 16.
RESULTS


Greater improvements in psychomotor and cognitive processing speeds within the first week, as well as better pretreatment performance in these domains, were specifically associated with higher likelihood of response to placebo. Moreover, better reward responsiveness, poorer cognitive control and greater verbal fluency were associated with greater likelihood of response to bupropion in patients who previously failed to respond to sertraline.
CONCLUSION


These exploratory results warrant further scrutiny, but demonstrate that quick and non-invasive behavioral tests may have substantial clinical value in predicting antidepressant treatment response.",2020,"RESULTS


Greater improvements in psychomotor and cognitive processing speeds within the first week, as well as better pretreatment performance in these domains, were specifically associated with higher likelihood of response to placebo.","['outpatients with non-psychotic recurrent MDD', 'major depressive disorder (MDD']","['sertraline or placebo', 'bupropion, sertraline, and placebo', 'sertraline selective serotonin reuptake inhibitor or placebo', 'bupropion noradrenaline/dopamine reuptake inhibitor or sertraline']","['Behavioral measures of reward responsiveness, cognitive control, verbal fluency, psychomotor, and cognitive processing speeds', 'reward responsiveness, poorer cognitive control and greater verbal fluency', 'psychomotor and cognitive processing speeds', 'Hamilton Rating for Depression scores']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0242980', 'cui_str': 'Dopamine reuptake inhibitor'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.137143,"RESULTS


Greater improvements in psychomotor and cognitive processing speeds within the first week, as well as better pretreatment performance in these domains, were specifically associated with higher likelihood of response to placebo.","[{'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Bruder', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Keilp', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Alschuler', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York, USA.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Pechtel', 'Affiliation': 'Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts, USA.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute and Columbia University Vagelos College of Physicians and Surgeons, New York, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deldin', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}]",Psychological medicine,['10.1017/S0033291720004286']
2595,33213722,Ticagrelor or Prasugrel in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes.,"BACKGROUND


Current guidelines recommend intensified platelet inhibition by prasugrel or ticagrelor in patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI).
OBJECTIVES


This study sought to investigate the benefits and risks of ticagrelor as compared with prasugrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management.
METHODS


This post hoc analysis combines the pre-specified subgroups of UA and NSTEMI of the randomized ISAR-REACT 5 trial. It included 1,179 patients assigned to ticagrelor and 1,186 assigned to prasugrel. Ticagrelor was started immediately after randomization and prasugrel after coronary angiography. The primary endpoint was a composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3-5.
RESULTS


The primary endpoint was reached in 101 (8.7%) patients in the ticagrelor and in 73 (6.3%) patients in the prasugrel group (hazard ratio [HR]: 1.41; 95% confidence interval [CI]: 1.04 to 1.90). The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19). The safety endpoint occurred in 49 (5.2%) patients in the ticagrelor and in 41 (4.7%) patients in the prasugrel group (HR: 1.09; 95% CI: 0.72 to 1.65). Landmark analysis revealed persistence of the efficacy advantage with prasugrel after the first month.
CONCLUSIONS


In patients with NSTE-ACS, we found that prasugrel was superior to ticagrelor in reducing the combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding. Due to the post hoc nature of the analysis, these findings need confirmation by further studies. (Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome; NCT01944800).",2020,The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19).,"['Patients With Acute Coronary Syndrome', 'Patients With Non-ST-Segment Elevation Acute Coronary Syndromes', 'patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) and planned invasive management', '1,179 patients assigned to', 'patients with unstable angina (UA) or non-ST-segment elevation (NSTE) myocardial infarction (MI']","['prasugrel', 'prasugrel or ticagrelor', 'Ticagrelor', 'Ticagrelor Versus\xa0Prasugrel', 'ticagrelor', 'Ticagrelor or Prasugrel']","['efficacy advantage', 'safety endpoint', 'composite of death, MI, or stroke during 1-year follow-up, and the safety endpoint was Bleeding Academic Research Consortium class 3-5', 'combined 1-year risk of death, MI, and stroke without increasing the risk of bleeding', 'HR for all-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0677743,The HR for all-cause death was 1.43 (95% CI: 0.93 to 2.21) and that for MI 1.43 (95% CI: 0.94 to 2.19).,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. Electronic address: franz-josef.neumann@universitaets-herzzentrum.de.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Ospedale Fabrizio Spaziani, Cardiology, Frosinone, Italy.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Department of Cardiology, Medical Campus Lake Constance, Friedrichshafen, Germany.'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Aytekin', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum Dachau, Cardiology & Pneumology, Dachau, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany; Klinik der Universität München, Ludwig-Maximilians-University, Cardiology, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Liebetrau', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Bad Neuheim, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, School of Medicine, Institute of Medical Informatics, Statistics and Epidemiology, Munich, Germany.'}, {'ForeName': 'Hendrik B', 'Initials': 'HB', 'LastName': 'Sager', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Wustrow', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Cardiology, and Technische Universität München, Munich, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.09.584']
2596,33213815,Hypnosis Versus Placebo During Atrial Flutter Ablation: The PAINLESS Study: A Randomized Controlled Trial.,"OBJECTIVES


The aim of this study was to assess the superiority of hypnosis versus placebo on pain perception and morphine consumption during typical atrial flutter (AFL) ablation.
BACKGROUND


AFL ablation commonly requires intravenous opioid for analgesia, which can be associated with adverse outcomes. Hypnosis is an alternative technique with rising interest, but robust data in electrophysiological procedures are lacking.
METHODS


This single center, randomized controlled trial compared hypnosis and placebo during AFl ablation. In addition to the randomized intervention, all patients were treated according to the institution's standard of care analgesia protocol (administration of 1 mg of intravenous morphine in case of self-reported pain ≥5 on an 11-point numeric rating scale or on demand). The primary endpoint was perceived pain quantified by patients using a visual analog scale.
RESULTS


Between October 2017 and September 2019, 113 patients (mean age 70 ± 12 years, 21% women) were randomized to hypnosis (n = 56) or placebo (n = 57). Mean pain score was 4.0 ± 2.2 in the hypnosis group versus 5.5 ± 1.8 in the placebo group (p < 0.001). Pain perception, assessed every 5 min during the whole procedure, was consistently lower in the hypnosis group. Patients' sedation scores were also better in the hypnosis group than in the placebo group (8.3 ± 2.2 vs. 5.4 ± 2.5; p < 0.001). Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001).
CONCLUSIONS


In this first randomized trial, hypnosis during AFL ablation was superior to placebo for alleviating pain and reducing morphine consumption.",2020,"Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001).
","['Between October 2017 and September 2019, 113 patients (mean age 70 ± 12 years, 21% women']","['care analgesia protocol (administration of 1\xa0mg of intravenous morphine', 'placebo', 'Hypnosis Versus Placebo', 'Flutter Ablation', 'hypnosis and placebo', 'hypnosis', 'hypnosis versus placebo']","['pain perception and morphine consumption', 'Pain perception', 'pain quantified by patients using a visual analog scale', 'sedation scores', 'alleviating pain\xa0and reducing morphine consumption', 'Mean pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.438033,"Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001).
","[{'ForeName': 'Rodrigue', 'Initials': 'R', 'LastName': 'Garcia', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France; Université de Poitiers, Faculté de Médecine et Pharmacie, Poitiers, France. Electronic address: rodrigue.garcia@chu-poitiers.fr.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bouleti', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France; Université de Poitiers, Faculté de Médecine et Pharmacie, Poitiers, France; INSERM CIC 1402, Poitiers, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': ""Cardiology Clinical Academic Group, St. George's University of London, London, United Kingdom.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Frasca', 'Affiliation': 'Université de Poitiers, Faculté de Médecine et Pharmacie, Poitiers, France; Centre Hopsitalier Universitaire (CHU) Poitiers, Anesthesia and Intensive Care, Poitiers, France.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'El Harrouchi', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Marechal', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Roumegou', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Corbi', 'Affiliation': 'Université de Poitiers, Faculté de Médecine et Pharmacie, Poitiers, France; Centre Hospitalier Universitaire (CHU) Poitiers, Department of Thoracic and Cardiovascular Surgery, Poitiers, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Christiaens', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France; Université de Poitiers, Faculté de Médecine et Pharmacie, Poitiers, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Le Gal', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Degand', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) Poitiers, Cardiology Department, Poitiers, France.'}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.05.028']
2597,33213976,The effect of vitamin D supplementation on the progression of benign prostatic hyperplasia: A randomized controlled trial.,"BACKGROUND AND AIMS


Inflammation and proliferation are the cause of benign prostatic hyperplasia (BPH) and are the key components of its mechanism of action. In this study we sought to determine the role of 25-hydroxyvitamin D in BPH, because of its anti-inflammatory activities, and its effect on prostate volume and BPH symptoms.
METHODS


This randomized clinical trial (RCT) was conducted on 108 participants >50 years of age who had either asymptomatic or mild BPH symptoms according to the International Prostate Symptom Score (IPSS) questionnaire. Patients were randomly divided into two groups, intervention and control. The intervention group received 50 000 units of vitamin D3 and the control group received a placebo every two weeks for six months. Prostate ultrasound, routine clinical examinations, toucher rectal (TR), and laboratory tests were performed for all patients. After six months, the patients underwent another ultrasound evaluation, measurement of prostate-specific antigen (PSA) levels and completed the IPSS. Results of the evaluations before and after the intervention were compared between the groups using the chi-square, t-test, and logistic regression analysis. Repeated measure analysis was used to evaluate the effect of vitamin D intervention on the changes in the IPSS score.
RESULTS


The mean age of the participants was 56 ± 9 years. In the control group, the mean prostate volume was higher compared to the intervention group (p < 0.001). The control group had a higher mean PSA level than the intervention group (p < 0.001). Although the IPSS score decreased over time in both groups, analysis of variance showed that the amount of change or decrease in IPSS score in the intervention group was significantly more than the control group (p < 0.001).
CONCLUSIONS


The results of our study support the effect of vitamin D in reducing prostate volume and PSA levels, and in improving BPH symptoms. Further studies are needed to confirm these findings to verify the use of vitamin D as a treatment for BPH.",2020,"In the control group, the mean prostate volume was higher compared to the intervention group (p < 0.001).","['108 participants >50 years of age who had either asymptomatic or mild BPH symptoms according to the International Prostate Symptom Score (IPSS) questionnaire', 'The mean age of the participants was 56\xa0±\xa09 years']","['vitamin D intervention', '50\xa0000 units of vitamin D3 and the control group received a placebo', 'vitamin D supplementation', 'vitamin D', '25-hydroxyvitamin D']","['mean PSA level', 'mean prostate volume', 'progression of benign prostatic hyperplasia', 'BPH symptoms', 'IPSS score', 'prostate-specific antigen (PSA) levels', 'Prostate ultrasound, routine clinical examinations, toucher rectal (TR), and laboratory tests', 'prostate volume and PSA levels']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0855818', 'cui_str': 'Ultrasound prostate'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",108.0,0.0606412,"In the control group, the mean prostate volume was higher compared to the intervention group (p < 0.001).","[{'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Zendehdel', 'Affiliation': 'Geriatrics Department, Associate Professor of Internal Medicine, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran; Family Medicine Department, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Radiology Department, Amir al-Momenin Hospital, Islamic Azad University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Khatami', 'Affiliation': 'Community Medicine Department, Tehran University of Medical Sciences, Tehran, Iran; Family Medicine Department, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Mansoursamaei', 'Affiliation': 'Family Medicine Department, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Dialameh', 'Affiliation': 'Department of Urology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: Hossein.dialameh@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.11.005']
2598,33214000,Would creatine supplementation augment exercise performance during a low carbohydrate high fat diet?,"Low carbohydrate high fat (LCHF) diets are emerging in popularity. Several athletics have adopted LCHF diets in an attempt to improve exercise performance and body composition by enhancing fat utilization. However, these diets impair maximal and supramaximal exercise performance due to limited glycogen stores as well as increasing ratings of perceived exertion (RPE). All of these factors may impact training volume and compliance, leading to less optimal training adaptations over time. In contrast, LCHF diets is an effective strategy for weight and fat mass loss and is beneficial for a variety of metabolic processes. One potential nutritional strategy to off-set the negative aspects of a LCHF is creatine (Cr). Creatine supplementation has been shown to increase muscle power output and reduce the rate of fatigue; thereby allowing individuals to work at a higher intensity for a greater duration. Furthermore, Cr supplementation may positively enhance body composition (gains in muscle mass and possibly aid in fat mass loss). Despite the popularity of both LCHF and creatine supplementation, there is no data available investigating the effects of Cr supplementation on exercise performance and body composition during LCHF diets in humans. We would hypothesize that Cr supplementation may augment exercise performance (anerobic power and strength) during a LCHF diet compared to a LCHF diet and placebo. In addition, combining Cr with a LCHF diet would further increase body fat loss and improve body composition compared to a LCHF diet and/or low-fat diets (LFDs) placebo. Our hypotheses would be under the assumption that total caloric intake and protein intake are matched. Future research is warranted to examine chronic exercise with LCHF diets with and without creatine and compare performance and body composition changes to high carbohydrate diets.",2020,We would hypothesize that Cr supplementation may augment exercise performance (anerobic power and strength) during a LCHF diet compared to a LCHF diet and placebo.,['humans'],"['Low carbohydrate high fat (LCHF) diets', 'Creatine supplementation', 'LCHF diets', 'creatine supplementation', 'LCHF diet and placebo', 'Cr supplementation']","['exercise performance and body composition', 'exercise performance (anerobic power and strength', 'body fat loss and improve body composition']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0424630', 'cui_str': 'Loss of body fat - finding'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0248571,We would hypothesize that Cr supplementation may augment exercise performance (anerobic power and strength) during a LCHF diet compared to a LCHF diet and placebo.,"[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'School of Nutrition and Dietetics, Faculty of Pure and Applied Science, Acadia University, Wolfville, Nova Scotia B4P 2R6, Canada. Electronic address: Mojtaba.kaviani@acadiau.ca.'}, {'ForeName': 'Azimeh', 'Initials': 'A', 'LastName': 'Izadi', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: izadia@tbzmed.ac.ir.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Heshmati', 'Affiliation': 'Department of Nutritional Science, School of Nutritional Science and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Medical hypotheses,['10.1016/j.mehy.2020.110369']
2599,33214014,Patellar Denervation Reduces Postoperative Anterior Knee Pain After Patellar Resurfacing Total Knee Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


The benefit of patellar denervation (PD) in patellar resurfacing total knee arthroplasty (TKA) is still debatable. This prospective, randomized controlled trial investigated whether circumferential PD should be performed in patellar resurfacing TKA.
METHODS


A total of 241 patients who underwent unilateral TKA were randomized into PD or non-PD groups. Incidence, intensity, and presentation time of anterior knee pain (AKP) and clinical outcomes were evaluated at 3, 6, 9, 12, 18, and 24 months postoperatively.
RESULTS


The incidence of AKP was significantly lower in the PD group (6.4% vs 16.2%, P = .032). The intensity of AKP and patient satisfaction scores were significantly better in the PD group at 3 months but not after 3 months. The presentation time of AKP mostly occurs at 3 months after surgery. The Knee Society score, range of motion, Oxford score, patellar score, activity of daily living score, and visual analog scale of overall knee pain were not significantly different between the two groups during the follow-up period.
CONCLUSION


Given that PD can improve AKP and patient satisfaction at an early period postoperatively without jeopardizing clinical outcomes at no additional cost, this inexpensive procedure readily available in nearly every operation room is strongly recommended during primary TKA with patellar resurfacing.",2020,The intensity of AKP and patient satisfaction scores were significantly better in the PD group at 3 months but not after 3 months.,"['patellar resurfacing total knee arthroplasty (TKA', 'After Patellar Resurfacing Total Knee Arthroplasty', '241 patients who underwent unilateral TKA']","['Patellar Denervation', 'PD', 'patellar denervation (PD', 'circumferential PD']","['incidence of AKP', 'Knee Society score, range of motion, Oxford score, patellar score, activity of daily living score, and visual analog scale of overall knee pain', 'Incidence, intensity, and presentation time of anterior knee pain (AKP) and clinical outcomes', 'AKP and patient satisfaction', 'Postoperative Anterior Knee Pain', 'intensity of AKP and patient satisfaction scores']","[{'cui': 'C1608424', 'cui_str': 'Patellar resurfacing'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",241.0,0.155941,The intensity of AKP and patient satisfaction scores were significantly better in the PD group at 3 months but not after 3 months.,"[{'ForeName': 'Satit', 'Initials': 'S', 'LastName': 'Thiengwittayaporn', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Pitch', 'Initials': 'P', 'LastName': 'Tangtrakul', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Natthapong', 'Initials': 'N', 'LastName': 'Hongku', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}, {'ForeName': 'Revit', 'Initials': 'R', 'LastName': 'Tunyasuwanakul', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University, Dusit, Bangkok, Thailand.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.10.046']
2600,33214082,Early dose reduction/delay and the efficacy of liposomal irinotecan with fluorouracil and leucovorin in metastatic pancreatic ductal adenocarcinoma (mPDAC): A post hoc analysis of NAPOLI-1.,"BACKGROUND


Chemotherapy dose modification to manage adverse events is commonplace in clinical practice. This exploratory analysis evaluates the impact of liposomal irinotecan dose modification on overall survival (OS) and progression-free survival (PFS) in the NAPOLI-1 clinical trial (NCT01494506).
METHODS


Analysis includes only patients enrolled under protocol version 2 who received at least the first 2 scheduled doses of study drug. Within the liposomal irinotecan +5 fluorouracil/leucovorin (5 FU/LV) arm, patients were grouped according to whether or not they had a dose modification within the first 6 weeks. Dose reduction was defined as any decrease from initial dose; dose delay was any dosing delay >3 days from target date. OS and PFS (Kaplan-Meier estimates) were compared within the liposomal irinotecan+5-FU/LV arm and between treatment arms. Unstratified hazard ratios (HRs) were calculated using Cox regression analysis.
RESULTS


Of the 93 patients from the liposomal irinotecan+5 FU/LV arm included in the analysis, 53 experienced a dose modification (both delay and reduction, n = 30; delay only, n = 19; reduction only, n = 4). No apparent difference in median OS or PFS was observed between patients who did versus patients who did not have a dose modification (OS: 8.4 vs 6.7 months; HR, 0.89; PFS: 4.2 vs 3.1 months; HR, 0.74).
CONCLUSION


An early dose reduction or delay of liposomal irinotecan+5-FU/LV in the first 6 weeks does not significantly impact OS or PFS compared to patients without dose modifications. This finding suggests that tolerability-guided dose modification of liposomal irinotecan does not adversely affect efficacy outcomes.",2020,"No apparent difference in median OS or PFS was observed between patients who did versus patients who did not have a dose modification (OS: 8.4 vs 6.7 months; HR, 0.89; PFS: 4.2 vs 3.1 months; HR, 0.74).
","['Analysis includes only patients enrolled under protocol version 2 who received at least the first 2 scheduled doses of study drug', 'metastatic pancreatic ductal adenocarcinoma (mPDAC', '93 patients from the liposomal irinotecan+5 FU/LV arm included in the analysis']","['liposomal irinotecan with fluorouracil and leucovorin', 'liposomal irinotecan+5-FU/LV', 'liposomal irinotecan', 'liposomal irinotecan\xa0+5 fluorouracil/leucovorin (5 FU/LV']","['Unstratified hazard ratios (HRs', 'median OS or PFS', 'overall survival (OS) and progression-free survival (PFS']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C4057931', 'cui_str': 'irinotecan liposomal'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",93.0,0.123287,"No apparent difference in median OS or PFS was observed between patients who did versus patients who did not have a dose modification (OS: 8.4 vs 6.7 months; HR, 0.89; PFS: 4.2 vs 3.1 months; HR, 0.74).
","[{'ForeName': 'Li-Tzong', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Health Research Institutes - National Institute of Cancer Research, Tainan, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: leochen@nhri.org.tw.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Jean-Frédéric', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Groupe Hospitalier Haut-Lévêque, CHU Bordeaux, Pessac, France.'}, {'ForeName': 'Beloo', 'Initials': 'B', 'LastName': 'Mirakhur', 'Affiliation': 'Ipsen Biopharmaceuticals Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Floris A', 'Initials': 'FA', 'LastName': 'de Jong', 'Affiliation': 'GlaxoSmith Kline, Zug, Switzerland.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Belanger', 'Affiliation': 'Ipsen Biopharmaceuticals Inc., Cambridge, MA, USA.'}, {'ForeName': 'Tanios', 'Initials': 'T', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'Jens T', 'Initials': 'JT', 'LastName': 'Siveke', 'Affiliation': 'German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Heidelberg, Germany, West German Cancer Center, University Hospital of Essen, Essen, Germany.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.10.029']
2601,33214190,"Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes.","INTRODUCTION


We compared the efficacy and safety of human regular insulin (HRI) versus rapid-acting insulin (RAI) in a type 2 diabetes population already using the V-Go insulin delivery device.
RESEARCH DESIGN AND METHODS


This was a 14-week, multicenter, randomized, open-label, parallel-group, phase IV, non-inferiority study. Patients ≥21years of age, with inadequately controlled type 2 diabetes who were currently using the V-Go insulin delivery system with RAI, with glycated hemoglobin (HbA1c) ≥6.5% (≥48 mmol/L) to ≤12.5% (≤108 mmol/L) were randomized 1:1 to RAI continuation or switch to HRI. The primary outcome was estimated treatment difference (ETD) in HbA1c least-squares mean change from baseline at 14 weeks (prespecified non-inferiority hypothesis with 95% CI upper limit <0.4%). Primary analysis was by per protocol (PP); safety analysis was by intention to treat.
RESULTS


We randomized 136 patients to continued RAI treatment (n=67) or HRI (n=69); 113 patients were included in the PP analysis (RAI, n=54; HRI, n=59). Mean change in HbA1c from baseline to study end was -0.60±1.1% (95% CI -0.90 to -0.29); -6.6±12.0 mmol/mol (95% CI -9.8 to -3.2) with HRI treatment and -0.38±1.3% (95% CI -0.70 to -0.05); -4.2±14.2 mmol/mol (95% CI -7.7 to -0.5) with RAI treatment, with ETD of -0.22% (95% CI -0.67 to 0.22); -2.4 mmol/mol (95% CI -7.3 to 2.4), p=0.007, confirming non-inferiority of HRI to RAI. No between-group differences in changes in total daily insulin doses, number of hypoglycemic values (≤70 mg/dL (≤39 mmol/L) or body weight were observed. No severe hypoglycemic events were reported. Direct pharmacy cost savings (-US$265.85; 95% CI -US$288.60 to -US$243.11; p<0.0001) were observed with HRI treatment.
CONCLUSIONS


Individuals with type 2 diabetes requiring insulin can be treated with V-Go wearable insulin delivery device using HRI, safely and effectively, and potentially at a much lower cost compared with RAI, which can lead to improved access to insulin therapy for these individuals.
TRIAL REGISTRATION NUMBER


NCT03495908.",2020,No severe hypoglycemic events were reported.,"['Individuals with type 2 diabetes requiring', 'type 2 diabetes', 'Patients ≥21years of age, with inadequately controlled type 2 diabetes who were currently using the V-Go insulin delivery system with RAI, with glycated hemoglobin (HbA1c) ≥6.5% (≥48\u2009mmol/L) to ≤12.5% (≤108\u2009mmol/L', '136 patients to continued RAI treatment (n=67) or HRI (n=69); 113 patients were included in the PP analysis (RAI, n=54; HRI, n=59']","['insulin', 'human regular insulin (HRI) versus rapid-acting insulin (RAI', 'U-100 human regular insulin and rapid acting insulin', 'RAI continuation or switch to HRI']","['Direct pharmacy cost savings', 'body weight', 'Mean change in HbA1c', 'Efficacy, safety and cost-effectiveness', 'total daily insulin doses, number of hypoglycemic values', 'severe hypoglycemic events', 'estimated treatment difference (ETD) in HbA1c least-squares mean change']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",136.0,0.274103,No severe hypoglycemic events were reported.,"[{'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Mora', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, The University of Texas Southwestern Medical Center, Dallas, Texas, USA pf_mora@yahoo.com.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Sutton', 'Affiliation': 'Northeast Florida Endocrine and Diabetes Associates, Jacksonville, Florida, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Gore', 'Affiliation': 'Jones Center for Diabetes and Endocrine Wellness, Macon, Georgia, USA.'}, {'ForeName': 'Bantwal', 'Initials': 'B', 'LastName': 'Baliga', 'Affiliation': 'East Alabama Endocrinology PC, Columbus, Ohio, USA.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Goldfaden', 'Affiliation': 'East Coast Institute for Research, LLC, Jacksonville, Florida, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nikkel', 'Affiliation': 'Zealand Pharma US Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sink Ii', 'Affiliation': 'Zealand Pharma US Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Independent Statistician, Coppell, Texas, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001832']
2602,33214209,Target-inhibition of Galectin-3 by Inhaled TD139 in Patients with Idiopathic Pulmonary Fibrosis.,"Galectin-3 (Gal-3) is a pro-fibrotic β-galactoside-binding lectin that plays a key role in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and IPF exacerbations. TD139 is a novel and potent small molecule inhibitor of Gal-3.A randomised, double-blind, multi-centre, placebo-controlled, phase I/IIa study was conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled TD139 in 36 healthy subjects and 24 patients with IPF (NCT02257177). Six dose cohorts of six healthy subjects were evaluated (4:2 TD139:placebo ratio) with single doses of TD139 (0.15 mg to 50 mg) and three dose cohorts of eight patients with IPF (5:3 TD139:placebo ratio) with once daily doses of TD139 (0.3 mg to 10 mg) for 14 days.Inhaled TD139 was well tolerated with no significant treatment-related side effects. TD139 was rapidly absorbed, with mean T max  values ranging from 0.6 h to 3 h and a T ½  of 8 h. The concentration of TD139 in the lung was >567-fold higher than in the blood, with systemic exposure predicting exposure in the target compartment. Gal-3 expression on alveolar macrophages was reduced in the 3 mg and 10 mg dose groups compared to placebo, with a concentration-dependent inhibition demonstrated. Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (PDGF-BB, PAI-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients. It was shown to suppress Gal-3 expression on BAL macrophages and, in a concerted fashion, decrease plasma biomarkers associated with IPF progression.",2020,"Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (PDGF-BB, PAI-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients.","['Six dose cohorts of six healthy subjects', 'Patients with Idiopathic Pulmonary Fibrosis', '36 healthy subjects and 24 patients with IPF (NCT02257177', 'healthy subjects and IPF patients']","['Galectin-3 (Gal-3', 'IPF (5:3 TD139:placebo ratio) with once daily doses of TD139', 'TD139', 'placebo']","['concentration of TD139', 'safety, tolerability, pharmacokinetics and pharmacodynamics', 'Gal-3 expression on alveolar macrophages']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}]","[{'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085236', 'cui_str': 'Alveolar macrophage'}]",36.0,0.0873179,"Inhibition of Gal-3 expression in the lung was associated with reductions in plasma biomarkers centrally relevant to IPF pathobiology (PDGF-BB, PAI-1, Gal-3, CCL18 and YKL-40).TD139 is safe and well tolerated in healthy subjects and IPF patients.","[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Hirani', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK n.hirani@ed.ac.uk.""}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'MacKinnon', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Nicol', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ford', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Schambye', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Pedersen', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Ulf J', 'Initials': 'UJ', 'LastName': 'Nilsson', 'Affiliation': 'Department of Chemistry, Lund University, Lund, Sweden.'}, {'ForeName': 'Hakon', 'Initials': 'H', 'LastName': 'Leffler', 'Affiliation': 'Department of Laboratory Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Sethi', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tantawi', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Gavelle', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Slack', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Mills', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Utsa', 'Initials': 'U', 'LastName': 'Karmakar', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Humphries', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Zetterberg', 'Affiliation': 'Galecto, Inc., Copenhagen N, Denmark.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Keeling', 'Affiliation': 'Exploristics, Belfast, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Paul', 'Affiliation': 'National Institute for Health Research Respiratory Clinical Research Facility, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Molyneaux', 'Affiliation': 'National Institute for Health Research Respiratory Clinical Research Facility, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""MRC Centre for Inflammation Research, The Queen's Medical Research Institute University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Funston', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Forrest', 'Affiliation': 'Respiratory Medicine Unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Simpson', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gibbons', 'Affiliation': 'Respiratory Department Royal Devon and Exeter NHS Foundation Trust Exeter, Institute of Biomedical and Clinical Science University of Exeter Medical School Exeter, Exeter, UK.'}, {'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Institute for Health Research Respiratory Clinical Research Facility, Royal Brompton and Harefield NHS Foundation Trust, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}]",The European respiratory journal,['10.1183/13993003.02559-2020']
2603,33214244,Randomised study evaluating the pharmacodynamics of emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease.,"BACKGROUND/AIMS


Stargardt disease is a rare, inherited, degenerative disease of the retina that is the most common type of hereditary macular dystrophy. Currently, no approved treatments for the disease exist. The purpose of this study was to characterise the pharmacodynamics of emixustat, an orally available small molecule that targets the retinal pigment epithelium-specific 65 kDa protein (RPE65), in subjects with macular atrophy secondary to Stargardt disease.
METHODS


In this multicentre study conducted at six study sites in the USA, 23 subjects with macular atrophy secondary to Stargardt disease were randomised to one of three doses of daily emixustat (2.5 mg, 5 mg or 10 mg) and treated for 1 month. The primary outcome was the suppression of the rod b-wave recovery rate on electroretinography after photobleaching, which is an indirect measure of RPE65 inhibition.
RESULTS


Subjects who received 10 mg emixustat showed near-complete suppression of the rod b-wave amplitude recovery rate postphotobleaching (mean=91.86%, median=96.69%), whereas those who received 5 mg showed moderate suppression (mean=52.2%, median=68.0%). No effect was observed for subjects who received 2.5 mg emixustat (mean=-3.31%, median=-12.23%). The adverse event profile was consistent with prior studies in other patient populations and consisted primarily of ocular adverse events likely related to RPE65 inhibition.
CONCLUSION


This study demonstrated dose-dependent suppression of rod b-wave amplitude recovery postphotobleaching, confirming emixustat's biological activity in patients with Stargardt disease. These findings informed dose selection for a 24-month phase 3 trial (SeaSTAR Study) that is now comparing emixustat to placebo in the treatment of Stargardt disease-associated macular atrophy.",2020,"No effect was observed for subjects who received 2.5 mg emixustat (mean=-3.31%, median=-12.23%).","['subjects with macular atrophy secondary to Stargardt disease', 'patients with Stargardt disease', '23 subjects with macular atrophy secondary to Stargardt disease']","['daily emixustat', 'emixustat hydrochloride', 'placebo']","['suppression of the rod b-wave recovery rate on electroretinography after photobleaching, which is an indirect measure of RPE65 inhibition', 'near-complete suppression of the rod b-wave amplitude recovery rate postphotobleaching', 'moderate suppression']","[{'cui': 'C0423421', 'cui_str': 'Atrophic macular change'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3884966', 'cui_str': 'emixustat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1532717', 'cui_str': 'kDa'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",23.0,0.0552967,"No effect was observed for subjects who received 2.5 mg emixustat (mean=-3.31%, median=-12.23%).","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kubota', 'Affiliation': 'President, Kubota Vision Inc, Seattle, Washington, USA rkubota@kubotavision.com.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Birch', 'Affiliation': 'Scientific Director, Retina Foundation of the Southwest, Dallas, Texas, USA.'}, {'ForeName': 'Jeff K', 'Initials': 'JK', 'LastName': 'Gregory', 'Affiliation': 'Clinical Development, Kubota Vision Inc, Seattle, Washington, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Koester', 'Affiliation': 'Clinical Development, Kubota Vision Inc, Seattle, Washington, USA.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-317712']
2604,33214331,Randomized Controlled Trial of High-Flow Nasal Cannula in Preterm Infants After Extubation.,"OBJECTIVES


Our aim is to compare the efficacy and safety of high-flow nasal cannula (HFNC) against those of nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV) after extubation in preterm infants.
METHODS


This prospective, randomized, noninferiority trial was conducted in 6 tertiary NICUs. Infants born at <34 weeks who needed noninvasive ventilation after extubation were enrolled. We randomly assigned infants to an HFNC group when HFNC was used or to an NCPAP/NIPPV group when NCPAP or NIPPV was used. The primary outcome was treatment failure within 7 days after extubation. We then examined clinical aspects of treatment failure with HFNC use.
RESULTS


In total, 176 and 196 infants were assigned to the HFNC and NCPAP/NIPPV groups, respectively. The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2). Histologic chorioamnionitis ( P  = .02), treated patent ductus arteriosus ( P  = .001), and corrected gestational age at the start of treatment ( P  = .007) were factors independently related to treatment failure with HFNC use.
CONCLUSIONS


We found HFNC revealed a significantly higher rate of treatment failure than NCPAP or NIPPV after extubation in preterm infants. The independent factors associated with treatment failure with HFNC use were histologic chorioamnionitis, treated patent ductus arteriosus, and a younger corrected gestational age at the start of treatment.",2020,"The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2).","['Preterm Infants', 'In total, 176 and 196 infants', 'Infants born at <34 weeks who needed noninvasive ventilation after extubation were enrolled', 'preterm infants']","['HFNC group when HFNC', 'HFNC', 'NCPAP/NIPPV group when NCPAP or NIPPV', 'NCPAP or NIPPV', 'NCPAP/NIPPV', 'High-Flow Nasal Cannula', 'high-flow nasal cannula (HFNC', 'HFNC and NCPAP/NIPPV', 'nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV']","['rate of treatment failure', 'efficacy and safety', 'treated patent ductus arteriosus ', 'treatment failure within 7 days after extubation', 'Histologic chorioamnionitis']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}]",196.0,0.233709,"The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Pediatrics and uchiyama.atsushi@tsc.u-tokai.ac.jp.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': ""Department of Neonatology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': ""Department of Neonatology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center and Saitama Medical University, Saitama, Japan; uchiyama.atsushi@tsc.u-tokai.ac.jp.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Motojima', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center and Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Namba', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center and Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Nagano', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, Nihon University, Tokyo, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, Nihon University, Tokyo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Kayama', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, Nihon University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Neonatology, Nagaoka Red Cross Hospital, Niigata, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Soeno', 'Affiliation': 'Department of Neonatology, Nagaoka Red Cross Hospital, Niigata, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Numata', 'Affiliation': 'Department of Neonatology, Nagaoka Red Cross Hospital, Niigata, Japan.'}, {'ForeName': 'Hideyo', 'Initials': 'H', 'LastName': 'Suenaga', 'Affiliation': ""Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Imai', 'Affiliation': ""Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Division of Neonatology, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Fujinaga', 'Affiliation': 'Division of Neonatology, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Furuya', 'Affiliation': 'Basic Clinical Science and Public Health, School of Medicine, Tokai University, Kanagawa, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Division of Neonatology, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2020-1101']
2605,33218533,"A comparison of the effects of different stretching methods on flexibility, muscle activity, and pain threshold in ballet dancers; a preliminary randomized controlled trial.","BACKGROUND


The purpose of this study is to compare the effects of stretching methods on flexibility, muscle activation, and pressure pain threshold in ballet dancers, and to suggest an effective stretching method.
METHODS


Thirty-three ballet dancers were randomized to the static stretching group (n = 11), muscle energy technique stretching group (n = 11), and vibration-assisted stretching group (n = 11). The angle of hip joint extension in arabesque, activation of the rectus femoris in devéloppé, and pressure pain threshold on the rectus femoris in the sitting position were measured to compare the effects of the different stretching methods. Paired t-test was used to compare the pre and post-intervention findings within each group and one-way analysis of variance to compare the difference in the amount of changes among the groups.
RESULTS


The hip joint extension angles increased in all stretching methods (p < 0.05); however, vibration-assisted stretching and muscle energy technique stretching were more effective than static stretching (p < 0.05). The activation of the rectus femoris decreased in all groups (p < 0.05); however the muscle energy technique stretching group and vibration-assisted stretching group showed a significant decrease in muscle activation compared with the static stretching group (p < 0.05). The pressure pain threshold significantly improved only in the static stretching group (p < 0.05); and vibration-assisted stretching group (p < 0.05).
CONCLUSIONS


Compared with static stretching and muscle energy technique stretching, vibration-assisted stretching is a beneficial method for improving flexibility, muscle activation, and pressure pain threshold in ballet dancers.",2020,"The hip joint extension angles increased in all stretching methods (p < 0.05); however, vibration-assisted stretching and muscle energy technique stretching were more effective than static stretching (p < 0.05).","['Thirty-three ballet dancers', 'ballet dancers']","['static stretching group (n\xa0=\xa011), muscle energy technique stretching group (n\xa0=\xa011), and vibration-assisted stretching group', 'static stretching', 'static stretching and muscle energy technique stretching, vibration-assisted stretching']","['pressure pain threshold', 'muscle activation', 'flexibility, muscle activation, and pressure pain', 'flexibility, muscle activity, and pain threshold', 'activation of the rectus femoris', 'hip joint extension angles']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0315433,"The hip joint extension angles increased in all stretching methods (p < 0.05); however, vibration-assisted stretching and muscle energy technique stretching were more effective than static stretching (p < 0.05).","[{'ForeName': 'Min Gyun', 'Initials': 'MG', 'LastName': 'Ko', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Mo', 'Initials': 'MM', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Daejeon University, Republic of Korea.'}, {'ForeName': 'Chang Ho', 'Initials': 'CH', 'LastName': 'Song', 'Affiliation': 'Department of Physical Therapy, Sahmyook University, Seoul, Republic of Korea. Electronic address: chsong@syu.ac.kr.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.019']
2606,33218534,Effects of Kinesio Taping on peak torque and muscle activity in women with low back pain presenting fears and beliefs related to physical activity.,"BACKGROUND


KT is an elastic taping that has been widely used as an adjunct to conventional physiotherapy. The purpose of this study was to evaluate the effects of Kinesio Taping on peak torque, muscle fatigue index and muscle activity of erector spinae in women with low back pain presenting fears and beliefs related to physical activity.
METHODS


This is a pilot controlled clinical trial. The subjects were divided into two groups according to the Fear Beliefs Avoidance Questionnaire (FABQ): Group A (Patients with no fears and/or beliefs related to physical activity) and Group B (Patients with fears and/or beliefs related to physical activity). The Kinesio Taping was applied in ""I"" in order to facilitate erector spinae. An isokinetic dynamometer and a surface electromyography were used to evaluate the outcomes. The evaluations were performed without and with the KT.
RESULTS


Sample of 16 women equally divided into two groups with similar characteristics regarding age, weight, height, body mass index, functional capacity and pain levels in the evaluations without and with Kinesio Taping. There were within-groups and between-groups differences in the peak torque (p ≤ .05), with better results in the Group B. No differences were found on muscle fatigue index and muscle activity in both groups (p > .05).
CONCLUSION


It was concluded that Kinesio Taping had immediate effects in the peak torque of the erector spinae of women with nonspecific chronic low back pain presenting fears and beliefs related to physical activity. It is suggested that such results occurred by placebo effect. NCT: RBR-5xh3ch.",2020,"There were within-groups and between-groups differences in the peak torque (p ≤ .05), with better results in the Group B. No differences were found on muscle fatigue index and muscle activity in both groups (p > .05).
","['Sample of 16 women', 'women with low back pain presenting fears and beliefs related to physical activity']","['NCT', 'RBR-5xh3ch', 'Kinesio Taping', 'Fear Beliefs Avoidance Questionnaire (FABQ): Group A (Patients with no fears and/or beliefs related to physical activity) and Group B (Patients with fears and/or beliefs related to physical activity']","['weight, height, body mass index, functional capacity and pain levels', 'peak torque', 'muscle fatigue index and muscle activity', 'peak torque and muscle activity', 'peak torque, muscle fatigue index and muscle activity of erector spinae']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}]",16.0,0.0176636,"There were within-groups and between-groups differences in the peak torque (p ≤ .05), with better results in the Group B. No differences were found on muscle fatigue index and muscle activity in both groups (p > .05).
","[{'ForeName': 'José Roberto', 'Initials': 'JR', 'LastName': 'de Souza Júnior', 'Affiliation': 'Universidade de Brasília, Brasília, Federal District, Brazil. Electronic address: joserobertofisio@gmail.com.'}, {'ForeName': 'Thiago Vilela', 'Initials': 'TV', 'LastName': 'Lemos', 'Affiliation': 'Universidade Estadual de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Tânia Cristina Dias da Silva', 'Initials': 'TCDDS', 'LastName': 'Hamu', 'Affiliation': 'Universidade Estadual de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Frederico Igor Ribeiro', 'Initials': 'FIR', 'LastName': 'Calaça', 'Affiliation': 'Universidade de Brasília, Brasília, Federal District, Brazil.'}, {'ForeName': 'Maikon Gleibyson Rodrigues', 'Initials': 'MGR', 'LastName': 'Dos Santos', 'Affiliation': 'Universidade de Brasília, Brasília, Federal District, Brazil.'}, {'ForeName': 'Amanda Marques', 'Initials': 'AM', 'LastName': 'Faria', 'Affiliation': 'Universidade Estadual de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Amanda Terra', 'Initials': 'AT', 'LastName': 'Silva', 'Affiliation': 'Universidade Estadual de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'João Paulo Chieregato', 'Initials': 'JPC', 'LastName': 'Matheus', 'Affiliation': 'Universidade de Brasília, Brasília, Federal District, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.012']
2607,33218535,Evaluation of scapular mobilization and comparison to pectoralis minor stretching in individuals with rounded shoulder posture: A randomized controlled trial.,"BACKGROUND


Rounded shoulder posture (RSP) is a common postural condition which can alter scapular position. Although, there is no consensus on the relationship between posture and musculoskeletal dysfunction, some evidence suggests a significant relationship between RSP and shoulder dysfunction. Therefore, treatment of this postural condition is important. Various treatment methods are used to correct RSP. However, the effectiveness of scapular mobilization, (SM) as a method which can alter scapular kinematics, has not been investigated.
OBJECTIVE


To evaluate the effects of SM on scapular resting position in individuals with RSP, and to compare this technique to pectoralis minor self-stretching (PMS), and combined SM + PMS.
METHODS


52 healthy students (18 men and 34 women; mean age 23.67 ± 6.73 years) with RSP were randomly assigned to four groups (SM, PMS, combined SM + PMS, control). The mobilization group received SM, the stretching group performed self-PMS, and the combined group received SM + PMS. The control group received no treatment. Kinematics data to measure scapular protraction (cm), anterior tilt (°), internal rotation (°), and downward rotation (°) were captured with a motion analysis system before and after 5 sessions of group intervention.
RESULTS


All variables decreased significantly post-intervention compared to baseline values (P < 0.05). Internal rotation and downward rotation decreased significantly in the intervention groups compared to the control group (P < 0.05). No significant differences were observed between the intervention groups.
CONCLUSION


SM appears to be an effective technique to change scapular resting position in individuals with RSP. However, this technique was not superior to PMS or a combination of SM + PMS.",2020,Internal rotation and downward rotation decreased significantly in the intervention groups compared to the control group (P < 0.05).,"['52 healthy students (18 men and 34 women; mean age 23.67\xa0±\xa06.73 years) with RSP', 'individuals with rounded shoulder posture', 'individuals with RSP']","['SM, the stretching group performed self-PMS, and the combined group received SM\xa0+\xa0PMS', 'SM', 'scapular mobilization and comparison to pectoralis minor stretching']","['Internal rotation and downward rotation', 'Kinematics data to measure scapular protraction (cm), anterior tilt (°), internal rotation (°), and downward rotation (°']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0224347', 'cui_str': 'Pectoralis minor muscle structure'}]","[{'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",52.0,0.0230511,Internal rotation and downward rotation decreased significantly in the intervention groups compared to the control group (P < 0.05).,"[{'ForeName': 'Maedeh', 'Initials': 'M', 'LastName': 'Fani', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maedeh.fani@gmail.com.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ebrahimis@sums.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghanbari', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Ali_ghanbari@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.021']
2608,33218539,Neurophysiological relationship of neuromuscular fatigue and stress disorder in PTSD patients.,"INTRODUCTION


Apart from mental disorders, other complications that have been reported in some patients with Post-Traumatic Stress Disorder (PTSD), include physical pain and being quick to fatigue, which can severely affect the patients' daily life. Therefore, this study aims to evaluate the relationship between PTSD and physical fatigue in people with PTSD.
METHOD


18 military men with (n = 9) and without PTSD (n = 9), with an age range of 45-60 years, volunteered to participate. They were randomly assigned into two groups: PTSD and non-PTSD groups. Recording of the surface electromyography (EMG) in a specific muscle was conducted twice in both groups, once at baseline and then again after a single session of fatiguing exercise. Data were analyzed by ANOVA with repeated measure (2✕2) at the significance level of 0.05.
RESULTS


Results showed that there was a significant main effect of intervention on electrical activity and neural conduction variables in the PTSD group (p = 0.04, p = 0.02). There was also an effect of time for the both variables (P < 0.001).
CONCLUSION


Stress disorders may affect the time to fatigue in PTSD patients and subsequently cause some difficulties in their daily life.",2020,"RESULTS


Results showed that there was a significant main effect of intervention on electrical activity and neural conduction variables in the PTSD group (p = 0.04,","['18 military men with (n\xa0=\xa09) and without PTSD (n\xa0=\xa09), with an age range of 45-60 years, volunteered to participate', 'PTSD patients', 'people with PTSD']","['surface electromyography (EMG', 'PTSD and non-PTSD']",['electrical activity and neural conduction variables'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0027788', 'cui_str': 'Nerve conduction'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",18.0,0.0250218,"RESULTS


Results showed that there was a significant main effect of intervention on electrical activity and neural conduction variables in the PTSD group (p = 0.04,","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Sarabzadeh', 'Affiliation': 'Department of Physiotherapy, Science and Research Branch, Aja University of Medical Sciences, Tehran, Iran. Electronic address: m.sarab68@yahoo.com.'}, {'ForeName': 'Manijeh', 'Initials': 'M', 'LastName': 'Soleimanifar', 'Affiliation': 'Department of Physiotherapy, Science and Research Branch, Aja University of Medical Sciences, Tehran, Iran; Lifestyle & Health Management Research Group, ACECR, Tehran, Iran. Electronic address: m.soleimanifar@ajaums.ac.ir.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Helalizadeh', 'Affiliation': 'Department of Exercise Physiology, Sport Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran. Electronic address: m.helalizadeh@ssrc.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.041']
2609,33218540,Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial.,"INTRODUCTION


The aim of the present study was to evaluate whether Fourth Ventricle Compression Technique (CV4) and Rib Raising (RR) osteopathic techniques influence Autonomic Nervous System (ANS) activity, as measured by Heart Rate Variability (HRV) and Skin Conductance (SC).
METHOD


A randomized-controlled clinical trial has been performed from June 2010 to January 2011. 32 healthy adults (33.9 ± 14 years, and 72% female) were selected. Subjects were randomized in three groups: CV4 group, RR group and Placebo group. Each subject of each group underwent respective technique only once. HRV and SC were continuously recorded during the session. All data analysis was performed using SPSS statistical software (version 21.0) and the significance level was considered at p ≤ 0.05.
RESULTS


RR technique intra-group subject analysis showed a significant decrease in LF/HF ratio (F = 25.18; p < 0.001), a statistically significant decrease of LF (F = 27.09; p < 0.001), and increase of HF, both at the end of treatment (F = 27.09; p < 0.001). CV4 technique intra-group subject analysis showed a significant reduction of the LF/HF ratio (F = 81.15; p < 0.001), a significant decrease in LF (F = 38.29; p < 0.001) and a significant increase of HF, at the end of treatment (F = 38.28; p < 0.001). Between-group analysis showed only a significant difference in LF/HF ratio between CV4 and PL groups (F = 3.44; p = 0.042).
DISCUSSION


Our results suggest that the application of CV4 and RR techniques favors a shift in the autonomic balance towards a parasympathetic predominant state. Thus, their use within OMT protocol, as holistic approach, might improve the outcome of the treatment of clinical neuro-vegetative conditions.",2020,"RESULTS


RR technique intra-group subject analysis showed a significant decrease in LF/HF ratio (F = 25.18; p < 0.001), a statistically significant decrease of LF (F = 27.09;","['June 2010 to January 2011', '32 healthy adults (33.9\xa0±\xa014 years, and 72% female']","['CV4 group, RR group and Placebo', 'CV4 and Rib Raising techniques', 'Fourth Ventricle Compression Technique (CV4) and Rib Raising (RR']","['LF/HF ratio', 'HF', 'HRV and SC', 'Heart Rate Variability (HRV) and Skin Conductance (SC', 'LF', 'autonomic balance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0450813', 'cui_str': 'CV4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0149556', 'cui_str': 'Fourth ventricle structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",32.0,0.0748217,"RESULTS


RR technique intra-group subject analysis showed a significant decrease in LF/HF ratio (F = 25.18; p < 0.001), a statistically significant decrease of LF (F = 27.09;","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Arienti', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy. Electronic address: carienti@dongnocchi.it.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Farinola', 'Affiliation': 'Division of Research, Istituto Superiore di Osteopatia, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ratti', 'Affiliation': 'Division of Research, Istituto Superiore di Osteopatia, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Daccò', 'Affiliation': 'Humanitas University, Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy; Department of Clinical Neurosciences, Villa San Benedetto Menni Hospital, Hermanas Hospitalarias, Via Roma 16, 22032 Albese con Cassano, Como, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fasulo', 'Affiliation': 'Osteopathic Clinic, ASP nr 9 of Mazara del Vallo, Trapani, Italy.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.002']
2610,33214158,Effects of Canagliflozin in Patients with Baseline eGFR <30 ml/min per 1.73 m 2 : Subgroup Analysis of the Randomized CREDENCE Trial.,"BACKGROUND AND OBJECTIVES


The Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial demonstrated that the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin reduced the risk of kidney failure and cardiovascular events in participants with type 2 diabetes mellitus and CKD. Little is known about the use of SGLT2 inhibitors in patients with eGFR <30 ml/min per 1.73 m 2 . The participants in the CREDENCE study had type 2 diabetes mellitus, a urinary albumin-creatinine ratio >300-5000 mg/g, and an eGFR of 30 to <90 ml/min per 1.73 m 2  at screening. This  post hoc  analysis evaluated participants with eGFR <30 ml/min per 1.73 m 2  at randomization.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Effects of eGFR slope through week 130 were analyzed using a piecewise, linear, mixed-effects model. Efficacy was analyzed in the intention-to-treat population, on the basis of Cox proportional hazard models, and safety was analyzed in the on-treatment population. At randomization (an average of 29 days after screening), 174 of 4401 (4%) participants had an eGFR <30 ml/min per 1.73 m 2  (mean [SD] eGFR, 26 [3] ml/min per 1.73 m 2 ).
RESULTS


From weeks 3 to 130, there was a 66% difference in the mean rate of eGFR decline with canagliflozin versus placebo (mean slopes, -1.30 versus -3.83 ml/min per 1.73 m 2  per year; difference, -2.54 ml/min per 1.73 m 2  per year; 95% confidence interval [CI], 0.90 to 4.17). Effects of canagliflozin on kidney, cardiovascular, and mortality outcomes were consistent for those with eGFR <30 and ≥30 ml/min per 1.73 m 2  (all  P  interaction >0.20). The estimate for kidney failure in participants with eGFR <30 ml/min per 1.73 m 2  (hazard ratio, 0.67; 95% CI, 0.35 to 1.27) was similar to those with eGFR ≥30 ml/min per 1.73 m 2  (hazard ratio, 0.70; 95% CI, 0.54 to 0.91;  P  interaction=0.80). There was no imbalance in the rate of kidney-related adverse events or AKI associated with canagliflozin between participants with eGFR <30 and ≥30 ml/min per 1.73 m 2  (all  P  interaction >0.12).
CONCLUSIONS


This  post hoc  analysis suggests canagliflozin slowed progression of kidney disease, without increasing AKI, even in participants with eGFR <30 ml/min per 1.73 m 2 .",2020,"There was no imbalance in the rate of kidney-related adverse events or AKI associated with canagliflozin between participants with eGFR <30 and ≥30 ml/min per 1.73 m 2  (all  P  interaction >0.12).
","['participants with type 2 diabetes mellitus and CKD', 'participants with eGFR <30 ml/min per 1.73 m 2  at randomization', 'participants in the CREDENCE study had type 2 diabetes mellitus, a urinary albumin-creatinine ratio >300-5000 mg/g, and an eGFR of 30 to <90 ml/min per 1.73 m 2  at screening', 'Patients with Baseline eGFR <30 ml/min per 1.73 m 2 ']","['canagliflozin', 'canagliflozin versus placebo', 'sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin', 'Canagliflozin']","['Efficacy', 'rate of kidney-related adverse events or AKI', 'kidney, cardiovascular, and mortality outcomes', 'mean rate of eGFR decline', 'kidney failure', 'kidney failure and cardiovascular events']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.370019,"There was no imbalance in the rate of kidney-related adverse events or AKI associated with canagliflozin between participants with eGFR <30 and ≥30 ml/min per 1.73 m 2  (all  P  interaction >0.12).
","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, Illinois gbakris@gmail.com.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Indiana University School of Medicine and Veterans Affairs Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Capuano', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Nephrology Division, New York University School of Medicine and New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': 'Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Oh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.10140620']
2611,33214162,Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial).,"BACKGROUND


Longstanding colonic IBD increases the risk of developing colorectal cancer. The utility of chromoendoscopy with standard-definition white light technology has been established. However, the use of high-definition virtual chromoendoscopy (HDV) in colitis surveillance remains undefined.
OBJECTIVE


To compare the performance of HDV (i-scan OE mode 2) with high-definition white light (HDWL) for detection of neoplasia in patients with IBD undergoing surveillance colonoscopy. Additionally, we assessed the utility of protocol-guided quadrantic non-targeted biopsies.
DESIGN


A multioperator randomised controlled trial was carried out in two centres in the UK. Total of 188 patients (101 men, mean age 54) with longstanding ulcerative or Crohn's colitis were randomised, prior to starting the surveillance colonoscopy, to using either HDV (n=94) or HDWL (n=94) on withdrawal. Targeted and quadrantic non-targeted biopsies were taken in both arms per-randomisation protocol. The primary outcome was the difference in neoplasia detection rate (NDR) between HDV and HDWL.
RESULTS


There was no significant difference between HDWL and HDV for neoplasia detection. The NDR was not significantly different for HDWL (24.2%) and HDV (14.9%) (p=0.14). All intraepithelial neoplasia (IEN) detected contained low-grade dysplasia only. A total of 6751 non-targeted biopsies detected one IEN only. The withdrawal time was similar in both arms of the study; median of 24 min (HDWL) versus 25.5 min (HDV).
CONCLUSION


HDV and HDWL did not differ significantly in the detection of neoplasia. Almost all neoplasia were detected on targeted biopsy or resection. Quadrantic non-targeted biopsies have negligible additional gain.
TRIAL REGISTRATION NUMBER


Clinical Trial.gov ID NCT02822352.",2020,The NDR was not significantly different for HDWL (24.2%) and HDV (14.9%) (p=0.14).,"['patients with IBD undergoing surveillance colonoscopy', 'two centres in the UK', 'A total of 6751 non-targeted biopsies detected one IEN only', ""188 patients (101 men, mean age 54) with longstanding ulcerative or Crohn's colitis""]","['HDV (n=94) or HDWL', 'protocol-guided quadrantic non-targeted biopsies', 'chromoendoscopy with standard-definition white light technology', 'virtual chromoendoscopy', 'high-definition white light (HDWL']","['neoplasia detection rate (NDR) between HDV and HDWL', 'withdrawal time', 'HDWL and HDV for neoplasia detection', 'HDV and HDWL', 'NDR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0878500', 'cui_str': 'Epithelial dysplasia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0156147', 'cui_str': ""Crohn's disease of large bowel""}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",6751.0,0.390479,The NDR was not significantly different for HDWL (24.2%) and HDV (14.9%) (p=0.14).,"[{'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Kandiah', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Sreedhari', 'Initials': 'S', 'LastName': 'Thayalasekaran', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Fergus Jq', 'Initials': 'FJ', 'LastName': 'Chedgy', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Gaius', 'Initials': 'G', 'LastName': 'Longcroft-Wheaton', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Fogg', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Brown', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Samuel Cl', 'Initials': 'SC', 'LastName': 'Smith', 'Affiliation': 'Institute of Immunology and Immunotherapy, NIHR Wellcome Trust Clinical Research Facilities, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Iacucci', 'Affiliation': 'Institute of Immunology and Immunotherapy, NIHR Wellcome Trust Clinical Research Facilities, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhandari', 'Affiliation': 'Department of Gastroenterology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK pradeep.bhandari@porthosp.nhs.uk.'}]",Gut,['10.1136/gutjnl-2020-320980']
2612,33214425,"Response to Comment on ""Effect of Remote Ischemic Preconditioning Conducted in Living Liver Donors on Postoperative Liver Function in Donors and Recipients Following Liver Transplantation: A Randomized Clinical Trial"".",,2020,,['Donors and Recipients Following Liver Transplantation'],[],['Postoperative Liver Function'],"[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",,0.0330466,,"[{'ForeName': 'Kyeo-Woon', 'Initials': 'KW', 'LastName': 'Jung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Laboratory for Cardiovascular Dynamics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun-Gol', 'Initials': 'JG', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Gyu-Sam', 'Initials': 'GS', 'LastName': 'Hwang', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004513']
2613,33214433,"Comments on: ""ALPPS Improves Survival Compared With TSH in Patients Affected of CRLM: Survival Analysis From the Randomized Controlled Trial LIGRO"" Survival Benefit of ALPPS versus TSH: a Proof of Concept or a Concept to be Proved?",,2020,,[],"['ALPPS', 'TSH', 'ALPPS versus TSH', 'CRLM']",['Survival'],[],"[{'cui': 'C0301811', 'cui_str': 'Alkaline phosphatase isoenzyme, placental fraction'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.262242,,"[{'ForeName': 'Marc Antoine', 'Initials': 'MA', 'LastName': 'Allard', 'Affiliation': 'AP-HP Hôpital Paul Brousse, Centre Hépatobiliaire, Université Paris Saclay, Villejuif, France Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA AP-HP Hôpital Paul Brousse, Centre Hépatobiliaire, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kitano', 'Affiliation': ''}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Imai', 'Affiliation': ''}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': ''}, {'ForeName': 'Jean-Nicolas', 'Initials': 'JN', 'LastName': 'Vauthey', 'Affiliation': ''}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004539']
2614,33214446,"Preoperative Hepatic and Regional Arterial Chemotherapy in Patients Who Underwent Curative Colorectal Cancer Resection: A Prospective, Multi-Center, Randomized Controlled Trial.","OBJECTIVE


To evaluate the effects of the addition of preoperative hepatic and regional arterial chemotherapy (PHRAC) on prognosis of stage II and III colorectal cancer (CRC) in a multicenter setting.
SUMMARY OF BACKGROUND DATA


Our previous single-center pilot trial suggested that PHRAC in combination with surgical resection could reduce the occurrence of liver metastasis (LM) and improve survival in CRC patients.
METHODS


A prospective multi-center randomized controlled trial was conducted from December 2008 to December 2012 at 5 hospitals in China. Eligible patients with clinical stage II or III CRC who underwent curative resection were randomized to receive PHRAC plus adjuvant therapy (PHRAC arm) or adjuvant therapy alone (control arm). The primary endpoint was disease-free survival (DFS). Secondary endpoints were cumulative LM rates, overall survival (OS) and safety (NCT00643877).
RESULTS


A total of 688 patients from 5 centers in China were randomly assigned (1:1) to each arm. The five-year DFS rate was 77% in the PHRAC arm and 65% in the control arm (HR = 0.61, 95% CI 0.46 to 0.81; P = 0.001). The five-year LM rates were 7% and 16% in the PHRAC and control arms, respectively (HR = 0.37, 95% CI 0.22 to 0.63; P < 0.001). The five-year OS rate was 84% in the PHRAC arm and 76% in the control arm (HR = 0.61, 95% CI 0.43 to 0.86; P = 0.005). There were no significant differences regarding treatment related morbidity or mortality between the two arms.
CONCLUSIONS


The addition of PHRAC could improve DFS in patients with stage II and III CRC. It reduced the incidence of LM and improved OS without compromising patient safety.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00643877.",2020,"There were no significant differences regarding treatment related morbidity or mortality between the two arms.
","['December 2008 to December 2012 at 5 hospitals in China', 'Patients', '688 patients from 5 centers in China', 'patients with stage II and III CRC', 'Eligible patients with clinical stage II or III CRC who underwent curative resection']","['Curative Colorectal Cancer Resection', 'PHRAC', 'preoperative hepatic and regional arterial chemotherapy (PHRAC', 'PHRAC plus adjuvant therapy (PHRAC arm) or adjuvant therapy alone (control arm', 'Preoperative Hepatic and Regional Arterial Chemotherapy']","['five-year OS rate', 'prognosis of stage II and III colorectal cancer (CRC', 'five-year LM rates', 'incidence of LM and improved OS', 'cumulative LM rates, overall survival (OS) and safety (NCT00643877', 'disease-free survival (DFS', 'morbidity or mortality', 'five-year DFS rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",688.0,0.242269,"There were no significant differences regarding treatment related morbidity or mortality between the two arms.
","[{'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital with Nanjing Medical University, Nanjing.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of General Surgery, the Affiliated Shanghai Ninth People's Hospital of Shanghai Jiao Tong University Medical School, Shanghai.""}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Colorectal Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Kefeng', 'Initials': 'K', 'LastName': 'Ding', 'Affiliation': 'Department of Surgical Oncology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Chunzhi', 'Initials': 'C', 'LastName': 'Qin', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Yunshi', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jiemin', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Wenju', 'Initials': 'W', 'LastName': 'Chang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Shaokang', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': 'Department of Statistics, School of Public Health, Fudan University, Shanghai.'}, {'ForeName': 'Yongbin', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of General Surgery, the First Affiliated Hospital with Nanjing Medical University, Nanjing.'}, {'ForeName': 'Haizhong', 'Initials': 'H', 'LastName': 'Huo', 'Affiliation': ""Department of General Surgery, the Affiliated Shanghai Ninth People's Hospital of Shanghai Jiao Tong University Medical School, Shanghai.""}, {'ForeName': 'Fanlong', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Junhui', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Colorectal Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai.'}]",Annals of surgery,['10.1097/SLA.0000000000004558']
2615,33214480,Randomized Trial of Laparoscopic Nissen vs. Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15-20 years.,"OBJECTIVE


To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen vs. anterior 180-degree partial fundoplication.
SUMMARY BACKGROUND DATA


Nissen fundoplication for gastroesophageal reflux can be followed by troublesome side effects. To address this, partial fundoplications have been proposed. Previously reports from a randomized controlled trial of Nissen vs. anterior 180-degree partial fundoplication at up to 10 years follow-up showed good outcomes for both procedures.
METHODS


107 participants were randomized to Nissen vs. anterior 180-degree partial fundoplication. 15-20 year follow-up data was available for 79 (41 Nissen, 38 anterior). Outcome was assessed using a standardized questionnaire with 0-10 analogue scores and yes/no questions to determine reflux symptoms, side-effects and satisfaction with surgery.
RESULTS


After anterior fundoplication heartburn (mean score 3.2 vs 1.4, p = 0.001) and proton pump inhibitor use (41.7% vs 17.1%, p = 0.023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, p = 0.015), and better ability to belch (84.2% vs 65.9%, p = 0.030). Measures of overall outcome were similar for both groups (mean satisfaction score 8.4 vs 8.0, p = 0.444; 86.8% vs 90.2% satisfied with outcome). Six participants underwent revision following anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision following Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1).
CONCLUSIONS


At 15-20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control vs. more side-effects after Nissen fundoplication.",2020,"After anterior fundoplication heartburn (mean score 3.2 vs 1.4, p = 0.001) and proton pump inhibitor use (41.7% vs 17.1%, p = 0.023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, p = 0.015), and better ability to belch (84.2% vs 65.9%, p = 0.030).","['15-20 years', 'Six participants underwent', '107 participants']","['revision following anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision following Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1', 'Nissen fundoplication', 'Laparoscopic Nissen vs. Anterior 180 Degree Partial Fundoplication', 'Nissen vs. anterior 180-degree partial fundoplication']","['dysphagia for solids', 'standardized questionnaire with 0-10 analogue scores and yes/no questions to determine reflux symptoms, side-effects and satisfaction with surgery']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C3887679', 'cui_str': 'Nissen fundoplication'}, {'cui': 'C0701808', 'cui_str': 'Partial fundoplication'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0267725', 'cui_str': 'Paraesophageal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",107.0,0.157431,"After anterior fundoplication heartburn (mean score 3.2 vs 1.4, p = 0.001) and proton pump inhibitor use (41.7% vs 17.1%, p = 0.023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, p = 0.015), and better ability to belch (84.2% vs 65.9%, p = 0.030).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Rudolph-Stringer', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Bright', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'University of Adelaide Discipline of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'University of Adelaide Discipline of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'University of Adelaide Discipline of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park.'}]",Annals of surgery,['10.1097/SLA.0000000000004643']
2616,33214484,"Comment on the article, ""Randomized Comparison of Gastric Tube Reconstruction with and Without Duodenal Diversion Plus Roux-en-Y Anastomosis after Esophagectomy"".",,2020,,[],['Gastric Tube Reconstruction with and Without Duodenal Diversion Plus Roux-en-Y Anastomosis after Esophagectomy'],[],[],"[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]",[],,0.0204814,,"[{'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Prakash', 'Affiliation': 'Department of Surgical Oncology, Mahamana Pt. Madan Mohan Malviya Cancer Centre, (MPMMCC) & Homi Bhabha Cancer Hospital (HBCH), Varanasi, India.'}, {'ForeName': 'Durgatosh', 'Initials': 'D', 'LastName': 'Pandey', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004617']
2617,33214515,Influence of Cardiopulmonary Resuscitation Coaching on Interruptions in Chest Compressions During Simulated Pediatric Cardiac Arrest.,"OBJECTIVES


To determine the impact of a cardiopulmonary resuscitation coach on the frequency and duration of pauses during simulated pediatric cardiac arrest.
DESIGN


This is a secondary analysis of video data collected from a prospective multicenter trial. Forty simulated pediatric cardiac arrest scenarios (20 noncoach and 20 coach teams), each lasting 18 minutes in duration, were reviewed by three clinical experts to document events surrounding each pause in chest compressions.
SETTING


Four pediatric academic medical centers from Canada and the United States.
SUBJECTS


Two-hundred healthcare providers in five-member interprofessional resuscitation teams that included either a cardiopulmonary resuscitation coach or a noncoach clinical provider.
INTERVENTIONS


Teams were randomized to include either a trained cardiopulmonary resuscitation coach or an additional noncoach clinical provider.
MEASUREMENTS AND MAIN RESULTS


The frequency, duration, and associated factors with each interruption in chest compressions were recorded and compared between the groups with and without a cardiopulmonary resuscitation coach, using t tests, Wilcoxon rank-sum tests, or chi-squared tests, depending on the distribution and types of outcome variables. Mixed-effect linear models were used to explore the effect of cardiopulmonary resuscitation coaching on pause durations, accounting for multiple measures of pause duration within teams. A total of 655 pauses were identified (noncoach n = 304 and coach n = 351). Cardiopulmonary resuscitation-coached teams had decreased total mean pause duration (98.6 vs 120.85 s, p = 0.04), decreased intubation pause duration (median 4.0 vs 15.5 s, p = 0.002), and similar mean frequency of pauses (17.6 vs 15.2, p = 0.33) when compared with noncoach teams. Teams with cardiopulmonary resuscitation coaches are more likely to verbalize the need for pause (86.5% vs 73.7%, p < 0.001) and coordinate change of the compressors, rhythm check, and pulse check (31.7% vs 23.2%, p = 0.05). Teams with cardiopulmonary resuscitation coach have a shorter pause duration than non-coach teams, adjusting for number and types of tasks performed during the pause.
CONCLUSIONS


When compared with teams without a cardiopulmonary resuscitation coach, the inclusion of a trained cardiopulmonary resuscitation coach leads to improved verbalization before pauses, decreased pause duration, shorter pauses during intubation, and better coordination of key tasks during chest compression pauses.",2020,"Teams with cardiopulmonary resuscitation coach have a shorter pause duration than non-coach teams, adjusting for number and types of tasks performed during the pause.
","['Forty simulated pediatric cardiac arrest scenarios (20 noncoach and 20 coach teams', 'Two-hundred healthcare providers in five-member interprofessional resuscitation teams that included either a', 'A total of 655 pauses were identified (noncoach n = 304 and coach n = 351', 'Four pediatric academic medical centers from Canada and the United States']","['cardiopulmonary resuscitation coach', 'trained cardiopulmonary resuscitation coach or an additional noncoach clinical provider', 'Cardiopulmonary Resuscitation Coaching', 'cardiopulmonary resuscitation coach or a noncoach clinical provider', 'cardiopulmonary resuscitation coaching']","['Chest Compressions', 'coordinate change of the compressors, rhythm check, and pulse check', 'frequency, duration, and associated factors with each interruption in chest compressions', 'intubation pause duration', 'frequency and duration of pauses', 'total mean pause duration']","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",655.0,0.0186079,"Teams with cardiopulmonary resuscitation coach have a shorter pause duration than non-coach teams, adjusting for number and types of tasks performed during the pause.
","[{'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Kessler', 'Affiliation': ""Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York Presbyterian Morgan Stanley Children's Hospital of New York, New York, NY.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Grabinski', 'Affiliation': ""Department of Emergency Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York Presbyterian Morgan Stanley Children's Hospital of New York, New York, NY.""}, {'ForeName': 'Lindsay N', 'Initials': 'LN', 'LastName': 'Shepard', 'Affiliation': ""Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York Presbyterian Morgan Stanley Children's Hospital of New York, New York, NY.""}, {'ForeName': 'Sara I', 'Initials': 'SI', 'LastName': 'Jones', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, KidSIM Simulation Education and Research Program, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Duff', 'Affiliation': ""Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, AB, Canada.""}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Tofil', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': ""Department of Pediatrics, Cumming School of Medicine, University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002623']
2618,33214919,Ultrasound assessment of upper airway dilator muscle contraction during transcutaneous electrical stimulation in patients with obstructive sleep apnoea.,"Background


Electrical current can be used to stimulate upper airway dilator muscles to treat obstructive sleep apnoea (OSA). Ultrasound devices are widely available and may be used to detect contraction of the upper airway dilator muscles assessing the functionality of electrical stimulation (ES) used for this treatment.
Methods


In a physiological sub-study of a randomised controlled trial, patients with OSA underwent ultrasound examination to assess contraction of the upper airway dilator muscles in response to transcutaneous ES. Ultrasound scans were scored according to the picture quality (poor = '0', acceptable = '1' and good = '2'). Tongue base thickness was assessed in mid-sagittal and coronal planes with (D2, A2) and without ES (D1, A1), while awake and seated. The primary outcome was to determine the increase in tongue thickness during ES in both views (D2 - D1 = ΔD), as well as any increase in the cross-sectional area (CSA) in the coronal view (A2 - A1 = ΔA). Data were presented as mean and standard deviation (SD).
Results


Fourteen patients [eight male, age 57.5 (9.8) years, body mass index (BMI) 29.5 (2.8) kg/m 2 ] with OSA [Apnea-Hypopnea Index (AHI) 19.5 (10.6) × hour -1 ] were studied. Quality of the ultrasound scans was acceptable or good with 1.5 (0.5) points. In the mid-sagittal plane, ΔD was +0.17 (0.07) cm in midline and +0.21 (0.09) cm in the widest diameter, a percentual change of 12.2% (4%) and 12.8% (5.2%) (P<0.001, respectively). In the coronal plane, ΔD was +0.17 (0.04) cm, an increase of 12.3% (4.6%) (P<0.001, respectively), ΔA in the CSA increased by +18.9% (3.0%) with stimulation (P<0.001). There was a negative correlation between age and ΔA (r= -0.6, P=0.03), but no significant associations were found with gender, BMI, neck circumference, Epworth Sleepiness Scale (ESS), AHI, skin and subcutaneous tissue in the submental area.
Conclusions


Ultrasound can visualise upper airway dilator muscle contraction during transcutaneous ES in awake patients with OSA. Contraction is best detected in the CSA of the tongue base in the coronal plane.",2020,"There was a negative correlation between age and ΔA (r= -0.6, P=0.03), but no significant associations were found with gender, BMI, neck circumference, Epworth Sleepiness Scale (ESS), AHI, skin and subcutaneous tissue in the submental area.
","['patients with obstructive sleep apnoea', 'awake patients with OSA', 'patients with OSA underwent', 'Fourteen patients [eight male, age 57.5 (9.8) years, body mass index']","['Ultrasound assessment of upper airway dilator muscle contraction', 'ultrasound examination', 'transcutaneous electrical stimulation']","['OSA [Apnea-Hypopnea Index', 'gender, BMI, neck circumference, Epworth Sleepiness Scale (ESS), AHI, skin and subcutaneous tissue in the submental area', 'tongue thickness during ES in both views (D2 - D1 = ΔD), as well as any increase in the cross-sectional area (CSA', 'CSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0870032', 'cui_str': 'Skin and/or subcutaneous tissue structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]",14.0,0.0313994,"There was a negative correlation between age and ΔA (r= -0.6, P=0.03), but no significant associations were found with gender, BMI, neck circumference, Epworth Sleepiness Scale (ESS), AHI, skin and subcutaneous tissue in the submental area.
","[{'ForeName': 'Miral', 'Initials': 'M', 'LastName': 'Al-Sherif', 'Affiliation': ""Lane Fox Unit/Sleep Disorders Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Baiting', 'Initials': 'B', 'LastName': 'He', 'Affiliation': ""Lane Fox Unit/Sleep Disorders Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Esther Irene', 'Initials': 'EI', 'LastName': 'Schwarz', 'Affiliation': ""Lane Fox Unit/Sleep Disorders Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cheng', 'Affiliation': ""Lane Fox Unit/Sleep Disorders Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Azza Farag', 'Initials': 'AF', 'LastName': 'Said', 'Affiliation': 'Department of Respiratory Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Nashwa Hassan', 'Initials': 'NH', 'LastName': 'AbdelWahab', 'Affiliation': 'Department of Respiratory Medicine, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Nezar', 'Initials': 'N', 'LastName': 'Refat', 'Affiliation': 'Department of Respiratory Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Yuanming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Centre of Human and Applied Physiological Sciences (CHAPS), Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Deeban', 'Initials': 'D', 'LastName': 'Ratneswaran', 'Affiliation': ""Lane Fox Unit/Sleep Disorders Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Steier', 'Affiliation': ""Lane Fox Unit/Sleep Disorders Centre, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}]",Journal of thoracic disease,['10.21037/jtd-cus-2020-001']
2619,33215007,Efficacy of internal limiting membrane peeling for diabetic macular edema after preoperative anti-vascular endothelial growth factor injection.,"AIM


To explore the efficacy of minimally invasive vitrectomy (MIV) with or without internal limiting membrane (ILM) peeling on the treatment of diabetic macular edema (DME) in proliferative diabetic retinopathy (PDR) combining with preoperative anti-vascular endothelial growth factor (anti-VEGF) injection.
METHODS


Totally 132 eyes (132 patients) diagnosed PDR with DME were included between June 2015 and June 2018 in Tianjin Eye Hospital. The single MIV treatment group included 68 eyes and the MIV combined with ILM peeling group included 64 eyes. Anti-VEGF drugs were injected intravitreally 1wk before the operation and the period of follow-up was 1 to 3y. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), total macular volume (TMV), macular edema (ME) severity, intraocular pressure (IOP), and complications were recorded. Prognostic factors of visual acuity following ILM peeling were analyzed.
RESULTS


The BCVA was higher than preoperative values at 1, 3, 6, and 12mo after surgery in both groups (all  P <0.05). At 6 and 12mo, the BCVA of the combined group was significantly higher than that of the MIV only group (0.52±0.23  vs  0.64±0.29 logMAR,  P =0.011 in 6mo; 0.41±0.25  vs  0.52±0.25 logMAR,  P =0.008 in 12mo). Mean CRT values postoperative were significantly lower than preoperative values in both groups from the 1 st  month (1mo 397.65±106.18  vs  451.94±118.88 µm in MIV only group; 388.88±108.68  vs  464.36±111.53 µm in combined group; both  P <0.05) and decreased gradually. The differences between the two groups were statistically significant at 3, 6, and 12mo ( P =0.004, 0.003, 0.00 respectively). The TMV was decreased from the 3 rd  month in the single treatment group (3mo 11.14±1.66  vs  12.20±2.09 mm 3 ,  P <0.05). At 12mo, the proportion of eyes with edema that had CRT more than 350 µm was significantly lower than before surgery (13.24%  vs  77.94% in MIV only group; 1.56%  vs  81.25% in combined group; both  P <0.05). There was no significant difference in the recurrence incidence of macular epiretinal membrane, ME, transient IOP increase, vitreous rebleeding, or traction retinal detachment between the two groups. BCVA after ILM excision was positively correlated with the CRT and ME degree before and after surgery ( r =0.430, 0.485, respectively;  P <0.05).
CONCLUSION


MIV combined with ILM peeling accelerates the absorption of ME, improves vision, reduces the postoperative CRT and TMV, and reduces the recurrence rate of postoperative ME.",2020,"There was no significant difference in the recurrence incidence of macular epiretinal membrane, ME, transient IOP increase, vitreous rebleeding, or traction retinal detachment between the two groups.","['diabetic macular edema (DME) in proliferative diabetic retinopathy (PDR', 'diabetic macular edema after preoperative anti-vascular endothelial growth factor injection', 'group included 64 eyes', 'Totally 132 eyes (132 patients) diagnosed PDR with DME were included between June 2015 and June 2018 in Tianjin Eye Hospital']","['preoperative anti-vascular endothelial growth factor (anti-VEGF', 'MIV combined with ILM peeling', 'ILM peeling', 'minimally invasive vitrectomy (MIV) with or without internal limiting membrane (ILM) peeling', 'internal limiting membrane peeling']","['recurrence incidence of macular epiretinal membrane, ME, transient IOP increase, vitreous rebleeding, or traction retinal detachment', 'BCVA', 'TMV', 'absorption of ME, improves vision', 'Mean CRT values postoperative', 'CRT and ME degree', 'proportion of eyes with edema that had CRT', 'Best-corrected visual acuity (BCVA), central retinal thickness (CRT), total macular volume (TMV), macular edema (ME) severity, intraocular pressure (IOP), and complications', 'postoperative CRT and TMV', 'recurrence rate of postoperative ME']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",132.0,0.036036,"There was no significant difference in the recurrence incidence of macular epiretinal membrane, ME, transient IOP increase, vitreous rebleeding, or traction retinal detachment between the two groups.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bi', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Shan-Na', 'Initials': 'SN', 'LastName': 'Chen', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Guang-Hui', 'Initials': 'GH', 'LastName': 'He', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 300070, China.'}]",International journal of ophthalmology,['10.18240/ijo.2020.11.12']
2620,33215008,Comparison of intravitreal injection of conbercept and triamcinolone acetonide for macular edema secondary to branch retinal vein occlusion.,"AIM


To compare the safety and efficacy of the intravitreal injection of conbercept (IVC) and triamcinolone acetonide (IVTA) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO).
METHODS


A prospective, randomized clinical study. Patients with ME secondary to BRVO were randomly assigned to either IVC group or IVTA group at a ratio of 2:1 and a 12-month follow-up was performed. The efficacy outcome measures included the mean changes and differences in best corrected visual acuity (BCVA) and the central retinal thickness (CRT). The safety profiles and the mean retreatment intervals were also compared.
RESULTS


There was no statistically significant difference of baseline between the two groups (IVC group,  n =36; IVTA group,  n =17). At 12mo, the BCVA letters improved by 27.31±18.36 in the IVC group, and 13.53±11.37 in the IVTA group ( P =0.0004). CRT reduction was 253.33±163.69 and 150.24±134.32 µm, respectively ( P =0.0034). The mean BCVA in the IVC group was superior to that of the IVTA group for months 6-12 ( P <0.01). The mean CRT at 9 and 12mo were thinner in the IVC group compared to the IVTA group ( P <0.01). The mean retreatment interval in the IVC group was longer than that in the IVTA group (97.40±36.27d  vs  68.71±36.38d,  P =0.0030). One eye in the IVC group and seven eyes in the IVTA group developed elevated intraocular pressure (IOP;  P =0.0012). The proportion of eyes with cataract new-onset or progression were 19.44% in the IVC group and 64.71% in the IVTA group ( P =0.0012).
CONCLUSION


IVC could maintain or improve BCVA and reduce CRT for a longer time and have longer retreatment interval than IVTA. In addition, patients treated with IVTA are more susceptible to IOP elevation and cataract progression.",2020,The mean BCVA in the IVC group was superior to that of the IVTA group for months 6-12 ( P <0.01).,"['macular edema secondary to branch retinal vein occlusion', 'macular edema (ME', 'Patients with ME secondary to BRVO']","['conbercept and triamcinolone acetonide', 'IVC group or IVTA', 'IVTA', 'intravitreal injection of conbercept (IVC) and triamcinolone acetonide (IVTA']","['BCVA letters', 'mean CRT', 'mean BCVA', 'proportion of eyes with cataract new-onset or progression', 'safety and efficacy', 'elevated intraocular pressure', 'BCVA and reduce CRT', 'IOP elevation and cataract progression', 'mean retreatment interval', 'CRT reduction', 'corrected visual acuity (BCVA) and the central retinal thickness (CRT']","[{'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0339505', 'cui_str': 'Venous retinal branch occlusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0414129,The mean BCVA in the IVC group was superior to that of the IVTA group for months 6-12 ( P <0.01).,"[{'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Ophthalmology, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Drug Clinical Trials Institution, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.'}, {'ForeName': 'Xi-Mei', 'Initials': 'XM', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Department of Ophthalmology, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.'}, {'ForeName': 'Tian-Wei', 'Initials': 'TW', 'LastName': 'Shi', 'Affiliation': 'Department of Ophthalmology, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, the Second Hospital of Dalian Medical University, Dalian 116027, Liaoning Province, China.'}]",International journal of ophthalmology,['10.18240/ijo.2020.11.13']
2621,33215010,Comparison of clinical outcomes after femtosecond laser  in situ  keratomileusis in eyes with low or high myopia.,"AIM


To compare the clinical results of femtosecond (FS) laser  in situ  keratomileusis (LASIK) in high myopic patients and low myopic patients.
METHODS


This study included 212 myopic eyes undergoing LASIK using a VisuMax 500kHz FS laser. All treated eyes were assigned to one of two groups according to preoperative manifest spherical refraction: low myopia group (A, >-4.0 D) and high myopia group (B, ≤-4.0 D). Uncorrected and corrected distance visual acuity (UDVA, CDVA), refractive errors, and higher-order aberrations (HOAs) were measured preoperatively and 1wk, 1, 3 and 6mo postoperatively.
RESULTS


At 6mo of follow-up, 92% and 76% had a UDVA of 20/20 or better in group A and B, respectively ( P =0.037) and UDVA was significantly different between two groups ( P =0.042). Six and seven percentage lost one line of CDVA in group A and B, respectively ( P =0.572) and no eyes in both groups lost more than two lines. Each group had 87% and 76% of treated eyes within ±0.5 D of the intended correction ( P =0.186), and 13% and 43% with a change of >0.50 D in spherical equivalent from 1wk to 6mo postoperatively ( P =0.005). In terms of postoperative astigmatism, each group had 89.1% and 76.6% within ±0.50 D, respectively and there was significant difference ( P =0.006). Group A tends to induce smaller HOAs than group B.
CONCLUSION


FS LASIK is effective and safe for correcting high myopia as well as low myopia. However, high myopic eyes showed more postoperative astigmatism and HOAs which affect visual acuity.",2020,"Six and seven percentage lost one line of CDVA in group A and B, respectively ( P =0.572) and no eyes in both groups lost more than two lines.","['eyes with low or high myopia', '212 myopic eyes undergoing LASIK using a', 'high myopic patients and low myopic patients']","['FS LASIK', 'femtosecond (FS) laser', 'femtosecond laser', 'VisuMax 500kHz FS laser']","['postoperative astigmatism and HOAs which affect visual acuity', 'UDVA', 'Uncorrected and corrected distance visual acuity (UDVA, CDVA), refractive errors, and higher-order aberrations (HOAs']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0271183', 'cui_str': 'Severe myopia'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]",212.0,0.0765871,"Six and seven percentage lost one line of CDVA in group A and B, respectively ( P =0.572) and no eyes in both groups lost more than two lines.","[{'ForeName': 'Su Hwan', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Pusan National University, Yangsan 50612, Gyeongnam Province, Republic of Korea.'}, {'ForeName': 'Cheng-Ye', 'Initials': 'CY', 'LastName': 'Che', 'Affiliation': 'Department of Ophthalmology, the Affiliated Hospital of Medical College, Qingdao University, Qingdao 266003, Shandong Province, China.'}, {'ForeName': 'Sung Il', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Pusan National University, Yangsan 50612, Gyeongnam Province, Republic of Korea.'}, {'ForeName': 'Choul Yong', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang 10326, Gyeonggi Province, Republic of Korea.'}, {'ForeName': 'Jong Heon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Busan Medical Center, Busan 47527, Republic of Korea.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'BalGunNun Eye Hospital, Busan 47195, Republic of Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Jung', 'Affiliation': 'BalGunNun Eye Hospital, Busan 47195, Republic of Korea.'}, {'ForeName': 'Jong Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Pusan National University, Yangsan 50612, Gyeongnam Province, Republic of Korea.'}, {'ForeName': 'Ji Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Pusan National University, Yangsan 50612, Gyeongnam Province, Republic of Korea.'}]",International journal of ophthalmology,['10.18240/ijo.2020.11.15']
2622,33215098,Minimum ten-year follow-up of a randomized trial comparing acetabular component fixation of two porous in-growth surfaces using radiosteriometric analysis.,"Aims


To compare the in vivo long-term fixation achieved by two acetabular components with different porous ingrowth surfaces using radiostereometric analysis (RSA).
Methods


This was a minimum ten-year follow-up of a prospective randomized trial of 62 hips with two different porous ingrowth acetabular components. RSA exams had previously been acquired through two years of follow-up. Patients returned for RSA examination at a minimum of ten years. In addition, radiological appearance of these acetabular components was analyzed, and patient-reported outcome measures (PROMs) obtained.
Results


In all, 15 hips were available at ten years. There was no statistically significant difference in PROMS between the two groups; PROMs were improved at ten years compared to preoperative scores. Conventional radiological assessment revealed well-fixed components. There was minimal movement for both porous surfaces in translation (X, Y, Z, 3D translation in mm (median and interquartile range (IQR)), StikTite (Smith and Nephew, Memphis, Tennessee, USA): 0.03 (1.08), 0.12 (0.7), 0.003 (2.3), 0.37 (0.30), and Roughcoat (Smith and Nephew): -0.6 (0.59),-0.1 (0.49), 0.1 (1.12), 0.48 (0.38)), and rotation (X, Y, Z rotation in degrees (median and IQR), (Stiktite: -0.4 (3), 0.28 (2), -0.2 (1), and Roughcoat: - 0.4 (1),-0.1 (1), 0.2 (2)). There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years. There was significant correlation between two years and ten years 3D translation for all components ( r  = 0.81(p =< 0.001)).
Conclusion


Both porous ingrowth surfaces demonstrated excellent fixation on plain radiographs and with RSA at ten years. Short-term RSA data are good predictors for long-term migration data.",2020,"There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years.","['62 hips with two different porous ingrowth acetabular components', '15 hips were available at ten years']",['acetabular component fixation'],"['Roughcoat', 'excellent fixation on plain radiographs', 'PROMS']","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0449349', 'cui_str': 'Acetabular component fixation'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}]",62.0,0.059987,"There was no statistically significant difference between the two cohorts (p-value for X, Y, Z, 3D translation - 0.54, 0.46, 0.87, 0.55 and for X, Y, Z rotation - 0.41, 0.23, 0.23 respectively) at ten years.","[{'ForeName': 'Luthfur', 'Initials': 'L', 'LastName': 'Rahman', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, The Rorabeck-Bourne Joint Replacement Institute, London, Ontario, Canada.'}, {'ForeName': 'Mazin S', 'Initials': 'MS', 'LastName': 'Ibrahim', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, The Rorabeck-Bourne Joint Replacement Institute, London, Ontario, Canada.'}, {'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Somerville', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, The Rorabeck-Bourne Joint Replacement Institute, London, Ontario, Canada.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Teeter', 'Affiliation': 'Department of Surgery, Schulich School of Medicine and Dentistry, London, Ontario, Canada.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Naudie', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, The Rorabeck-Bourne Joint Replacement Institute, London, Ontario, Canada.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'McCalden', 'Affiliation': 'London Health Sciences Centre, University of Western Ontario, The Rorabeck-Bourne Joint Replacement Institute, London, Ontario, Canada.'}]",Bone & joint open,['10.1302/2633-1462.110.BJO-2020-0118.R1']
2623,33215359,The Effect of Acute Interpersonal Racial Discrimination on Smoking Motivation and Behavior Among Black Smokers: an Experimental Study.,"In comparison to White smokers, Black smokers are likely to report both more discrimination and less success in smoking cessation. No previous study has tested the causal relationship between an experience of racial discrimination and smoking variables associated with cessation. The goal of this study was to test the causal influence of interpersonal racial discrimination on smoking motivation (i.e., the urge to smoke cigarettes, cessation self-efficacy, and smoking behavior) using a controlled experimental design. We used a virtual ball-playing game to create a laboratory model of racial discrimination. A 2 × 2 between-subjects factorial design (inclusion/exclusion vs. ingroup/outgroup) was used to randomly assign participants to one of four groups: (1) included/ingroup, (2) included/outgroup, (3) excluded/ingroup (ostracism), and (4) excluded/outgroup (racial discrimination). Sixty-nine Black smokers were recruited from the community. Participants in the excluded conditions reported lower cessation self-efficacy than those in the included conditions. Participants in the outgroup conditions had reduced latency to smoke compared to those in the ingroup conditions. There were no main effects of social inclusion on cravings or latency to smoke and no statistically significant interactions for social inclusion × group membership. This laboratory simulation of racial discrimination shows a causal relationship between exclusion and low cessation self-efficacy, which contributes to a better understanding of influences upon smoking cessation attempts among Black smokers.",2020,There were no main effects of social inclusion on cravings or latency to smoke and no statistically significant interactions for social inclusion × group membership.,"['Sixty-nine Black smokers', 'A 2\u2009×\u20092 between-subjects factorial design (inclusion/exclusion vs. ingroup/outgroup) was used to randomly assign participants to one of four groups: (1) included/ingroup, (2) included/outgroup, (3) excluded/ingroup (ostracism), and (4) excluded/outgroup (racial discrimination', 'Black smokers', 'Black Smokers']",['Acute Interpersonal Racial Discrimination'],"['cessation self-efficacy', 'urge to smoke cigarettes, cessation self-efficacy, and smoking behavior', 'latency to smoke', 'Smoking Motivation and Behavior', 'cravings or latency to smoke']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205905', 'cui_str': 'Racial Discrimination'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205905', 'cui_str': 'Racial Discrimination'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",69.0,0.0115875,There were no main effects of social inclusion on cravings or latency to smoke and no statistically significant interactions for social inclusion × group membership.,"[{'ForeName': 'Patricia F', 'Initials': 'PF', 'LastName': 'Calixte-Civil', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, USA. Patricia.CalixteCivil@moffitt.org.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00914-4']
2624,33215362,"A Randomized, Controlled Trial Comparing the Impact of a Low-Calorie Ketogenic vs a Standard Low-Calorie Diet on Fat-Free Mass in Patients Receiving an Elipse™ Intragastric Balloon Treatment.","BACKGROUND


The Elipse™ intragastric balloon (EIGB) is a new swallowable balloon for weight loss (WL). Preserving metabolically active fat-free mass (FFM) and resting metabolic rate (RMR) during WL are crucial to maximize fat mass (FM) loss. After EIGB placement, a standard low-calorie diet (LCD) is generally prescribed. A low-calorie ketogenic diet (LCKD) has proven to be safe and effective in reducing FM while preserving FFM and RMR.
OBJECTIVE


To prospectively compare the effects on WL, FM, FFM, and RMR in two groups of patients who were randomized to two different diets: LCKD and a standard LCD after EIGB placement.
METHODS


WL, FM, FFM, and RMR were measured before EIGB and at 4 months in 48 patients who received either a LCKD (n = 24) or a standard LCD (n = 24). Compliance in following the prescribed diet was determined with food frequency questionnaires in all patients. The impact of LCKD and LCD on renal function was also evaluated.
RESULTS


The LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively). FM decreased more significantly with LCKD compared to LCD (41.6 vs 33.1%, p = 0.0606). Compliance in following the prescribed diets, without negative impact on renal function, was found.
CONCLUSION


Based on our findings, despite the small sample size, we were able to support the hypothesis that LCKD is associated with an increased FM loss while reducing the FFM loss and the RMR, without interfering with renal function after EIGB.",2020,"The LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively).","['two groups of patients who were randomized to two different diets: LCKD and a standard LCD after EIGB placement', 'Patients Receiving an Elipse™ Intragastric Balloon Treatment', '48 patients who received either a']","['LCKD and LCD', 'LCD', 'LCKD', 'low-calorie ketogenic diet (LCKD', 'standard LCD', 'standard low-calorie diet (LCD', 'Low-Calorie Ketogenic vs a Standard Low-Calorie Diet', 'Elipse™ intragastric balloon (EIGB']","['FM', 'Fat-Free Mass', 'FM loss', 'FFM and RMR', 'FM, FFM, and RMR', 'renal function', 'Preserving metabolically active fat-free mass (FFM) and resting metabolic rate (RMR']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",48.0,0.048542,"The LCKD group showed a significantly lower decrease in FFM and RMR when compared with the LCD group (3.55 vs 14.3%, p < 0.001; 9.79 vs 11.4%, p < 0.001, respectively).","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Schiavo', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy. lschiavo@unisa.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'De Stefano', 'Affiliation': 'Med.Ita Advanced Biomedical Solutions, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Persico', 'Affiliation': 'Unit of General and Specialistic Surgery, A.O.R.N. dei Colli Ospedali Monaldi-Cotugno-CTO, Naples, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gargiulo', 'Affiliation': 'General Surgery Unit, Santa Maria La Bruna Clinic, Torre del Greco, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Di Spirito', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Petrucciani', 'Affiliation': 'Digestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202, Nice, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': 'Direction de la Recherche Clinique, University Hospital, Nice, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Iannelli', 'Affiliation': 'Digestive Unit, Archet 2 Hospital, University Hospital of Nice, F-06202, Nice, France.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pilone', 'Affiliation': 'Department of Medicine, Surgery, and Dentistry, ""Scuola Medica Salernitana"", University of Salerno, Fisciano, SA, Italy.'}]",Obesity surgery,['10.1007/s11695-020-05133-8']
2625,33215434,Energy-restricted Central-European diet stimulates liver microsomal function in obese postmenopausal women - a randomized nutritional trial with a comparison to energy-restricted Mediterranean diet.,"OBJECTIVE


Obesity and metabolic syndrome are risk factors for liver diseases like non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. A healthy food pattern is vital for managing these health problems, therefore, this study investigated how two calorie-restricted diets, the Central European diet (CED) and Mediterranean diet (MED), altered microsomal liver function in obese postmenopausal women with a risk of metabolic syndrome.
PATIENTS AND METHODS


One-hundred-forty-four subjects were randomly assigned to the CED (n=72) or the MED (n=72) groups. A 13C-methacetin breath test was performed, before and after the intervention to assess CPDR (Cumulative Percentage Dose Recovery at 120 minutes of the test), TTP (Time to Peak - maximal momentary recovery of 13C) and Vmax (the maximum momentary 13C recovery).
RESULTS


There was a statistically significant increase in TTP and Vmax in the CED group only (p=0.0159 and p=0.0498, respectively). Changes in CPDR and TTP due to intervention were significantly higher in the CED group than in the MED group (p=0.0440 and p=0.0115, respectively).
CONCLUSIONS


This is the first study to document a stimulatory effect of the energy-restricted CED on liver microsomal function as compared to MED. The relatively short dietary intervention led to a significant difference in the CYP1A2 activity between groups. The trial was registered in the German Clinical Trials Register (DRKS-ID: DRKS00012958; URL: https://www.germanctr.de/).",2020,"There was a statistically significant increase in TTP and Vmax in the CED group only (p=0.0159 and p=0.0498, respectively).","['obese postmenopausal women with a risk of metabolic syndrome', 'n=72) or the MED (n=72) groups', 'obese postmenopausal women', 'One-hundred-forty-four subjects']","['energy-restricted CED', 'Energy-restricted Central-European diet', 'Central European diet (CED) and Mediterranean diet (MED', 'TTP', 'CED']","['TTP and Vmax', 'CPDR', 'Changes in CPDR and TTP due to intervention', 'CYP1A2 activity', 'liver microsomal function']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}]","[{'cui': 'C0034155', 'cui_str': 'Thrombotic thrombocytopenic purpura'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0207509', 'cui_str': 'Cytochrome p450 CYP1A2 enzyme'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",144.0,0.0387142,"There was a statistically significant increase in TTP and Vmax in the CED group only (p=0.0159 and p=0.0498, respectively).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Szczepanik', 'Affiliation': 'Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poland. jarwalk@ump.edu.pl.'}, {'ForeName': 'I J', 'Initials': 'IJ', 'LastName': 'Malesza', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bajerska', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chmurzyńska', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muzsik', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bermagambetova', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mądry', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Walkowiak', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lisowska', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202011_23604']
2626,33215456,Azathioprine for prevention of clinical recurrence in Crohn's disease patients with severe endoscopic recurrence: an IG-IBD randomized double-blind trial.,"OBJECTIVE


The recurrence of Crohn's Disease after ileo-colonic resection is a crucial issue. Severe endoscopic lesions increase the risk of developing early symptoms. Prevention and treatment of post-operative Endoscopic Recurrence (ER) have been studied with conflicting results. We compare effi cacy of azathioprine (AZA) vs. high-dose 5-aminosalicylic acid (5-ASA) in preventing clinical recurrence and treating severe post-operative ER.
PATIENTS AND METHODS


We performed a 1-year multicenter randomized double-blind double-dummy trial. Primary end-points were endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events) 12 months after randomization. We also performed a post-trial analysis on symptomatic and endoscopic outcomes 10 years after the beginning of the trial, with a median follow-up of 60 months.
RESULTS


Therapeutic failure occurred in 8 patients (17.4%) within 12 months from randomization, with no significant difference between patients treated with 5-ASA (20.8%, 5 patients) and those with AZA (13.6%, 3 patients). Therapeutic failure was due to clinical recurrence in the 5-ASA group and to adverse events in the AZA group. Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group. No serious adverse event was recorded. At the post-trial analysis (median follow-up 60 months), 47.8% (22/46) of patients experienced clinical recurrence: 54.2% (13/24) in the 5-ASA group and 40.9% (9/22) in the AZA group, p=0.546. Patients treated with AZA had lower risk of drug escalation. Clinical recurrence was associated with smoking (p=0.031) and previous surgery (p=0.003).
CONCLUSIONS


Our trial indicates that there was no difference in terms of treatment failure between 5-ASA and AZA in patients with severe ER. The main limit of AZA is its less favorable safety profile.",2020,"Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group.","['patients with severe ER', ""Crohn's disease patients with severe endoscopic recurrence""]","['azathioprine (AZA) vs. high-dose 5-aminosalicylic acid (5-ASA', 'post-operative Endoscopic Recurrence (ER', '5-ASA', 'Azathioprine', 'AZA', '5-ASA and AZA']","['Clinical recurrence', 'lower risk of drug escalation', 'endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events', 'clinical recurrence', 'Endoscopic improvement', 'Therapeutic failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.725759,"Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Orlando', 'Affiliation': 'IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy. fmocciaro@gmail.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mocciaro', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ventimiglia', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Renna', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Scribano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Testa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aratari', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bossa', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Angelucci', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Onali', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappello', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giunta', 'Affiliation': ''}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Macaluso', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Scimeca', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Macaluso', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Papi', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Annese', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Biancone', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kohn', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Di Mitri', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cottone', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202011_23627']
2627,33218567,Day of peak pain reduction by a single session of dry needling in the upper trapezius myofascial trigger points: A 14 daily follow-up study.,"BACKGROUND


Dry needling (DN) is commonly used to inactivate myofascial trigger points (MTrPs). However, a daily report of pain reduction has not been determined.
OBJECTIVE


The aim was to evaluate the time of the greatest pain relief after performing a single session of DN in MTrPs of the upper trapezius muscle.
METHODS


A patient who had MTrPs in the upper trapezius muscle was enrolled into a prospective descriptive study. Each patient received a single session of DN, using a fast-in-fast-out technique, with needle retention for 30 min. Numerical rating scale (NRS) scores were collected daily for 14 days. The mean difference of pain and an effect size were calculated. The 1-5 satisfaction score was a secondary outcome.
RESULTS


Sixty-seven subjects completed the intervention. The mean duration of the symptom was 27.32 months. The mean baseline NRS score was 5.30. The pain decreased significantly between immediate post-procedure and 1 day after the DN treatment from 5.16 to 3.40 (mean difference 1.76, p < 0.01, effect size = 0.87). The pain continuously reduced until day 10 and then it gradually rose. The pain on day 10 was compared with the baseline that revealed the largest effect size of 3.08 (mean difference 4.67, p < 0.01). Eighty-eight percent of the subjects were very satisfied with their treatment.
CONCLUSIONS


A single session of DN treatment in the upper trapezius MTrPs combined with self-stretching exercises could greatly reduce pain between immediate post-procedure and 1 day after DN treatment. The peak effect on pain reduction occurred on day 10.",2020,"The pain on day 10 was compared with the baseline that revealed the largest effect size of 3.08 (mean difference 4.67, p < 0.01).","['Sixty-seven subjects completed the intervention', 'A patient who had MTrPs in the upper trapezius muscle']","['Dry needling (DN', 'dry needling']","['pain relief', 'mean duration of the symptom', 'Numerical rating scale (NRS) scores', 'peak pain reduction', 'pain reduction', 'mean baseline NRS score', 'mean difference of pain and an effect size', 'pain']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0713917,"The pain on day 10 was compared with the baseline that revealed the largest effect size of 3.08 (mean difference 4.67, p < 0.01).","[{'ForeName': 'Phichamon', 'Initials': 'P', 'LastName': 'Khanittanuphong', 'Affiliation': 'Rehabilitation Division, Department of Orthopaedics and Rehabilitation Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand. Electronic address: phichamon.k@psu.ac.th.'}, {'ForeName': 'Phichaporn', 'Initials': 'P', 'LastName': 'Upho', 'Affiliation': 'Rehabilitation Division, Department of Orthopaedics and Rehabilitation Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.040']
2628,33215153,Can the results of a randomized controlled trial change the treatment preferences of orthopaedic surgeons?,"Aims


The aim of this study was to investigate surgeons' reported change of treatment preference in response to the results and conclusion from a randomized contolled trial (RCT) and to study patterns of change between subspecialties and nationalities.
Methods


Two questionnaires were developed through the Delphi process for this cross-sectional survey of surgical preference. The first questionnaire was sent out before the publication of a RCT and the second questionnaire was sent out after publication. The RCT investigated repair or non-repair of the pronator quadratus (PQ) muscle during volar locked plating of distal radial fractures (DRFs). Overall, 380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied. One hundred surgeons were invited to participate in the second questionnaire. The primary outcome was the proportion of surgeons for whom a treatment change was warranted, who then reported a change of treatment preference following the RCT. Secondary outcomes included the reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year.
Results


Of the 100 surgeons invited for the second questionnaire, 74 replied. For the primary outcome, six of 32 surgeons (19%), who usually repaired the PQ muscle and therefore a change of treatment preference was warranted, reported a change of treatment preference based on the RCT publication. Of the secondary outcomes, restoring anatomy was the most common response for repairing the PQ muscle.
Conclusion


The majority of the orthopaedic surgeons, where a change of treatment preference was warranted based on the results and conclusion of a RCT, did not report willingness to change their treatment preference.Cite this article:  Bone Joint Open  2020;1-9:549-555.",2020,"Results


Of the 100 surgeons invited for the second questionnaire","['100 surgeons invited for the second questionnaire', 'One hundred surgeons were invited to participate in the second questionnaire', '380 orthopaedic surgeons were invited to participate in the first questionnaire, of whom 115 replied']",[],"['reasons for repair or non-repair, reasons for and against following the RCT results, and difference of preferred treatment of the PQ muscle between surgeons of different nationalities, qualifications, years of training, and number of procedures performed per year', 'proportion of surgeons']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C4517540', 'cui_str': '115'}]",[],"[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0027473', 'cui_str': 'Nationality'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439508', 'cui_str': '/year'}]",100.0,0.0573842,"Results


Of the 100 surgeons invited for the second questionnaire","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Sonntag', 'Affiliation': 'Department of Orthopaedic Surgery, Nordsjaellands Hospital, University of Copenhagen, Hilleroed, Denmark.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Landale', 'Affiliation': 'Department of Orthopaedic Surgery, Tamworth Rural Referral Hospital, Tamworth, Australia.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Brorson', 'Affiliation': 'Department of Orthopaedic Surgery, Zealand University Hospital and Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Harris', 'Affiliation': 'Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}]",Bone & joint open,['10.1302/2633-1462.19.BJO-2020-0093.R1']
2629,33215157,Assessment of technical skill in hip fracture surgery using the postoperative radiograph: pilot development and validation of a final product analysis core outcome set.,"Aims


To develop a core outcome set of measurements from postoperative radiographs that can be used to assess technical skill in performing dynamic hip screw (DHS) and hemiarthroplasty, and to validate these against Van der Vleuten's criteria for effective assessment.
Methods


A Delphi exercise was undertaken at a regional major trauma centre to identify candidate measurement items. The feasibility of taking these measurements was tested by two of the authors (HKJ, GTRP). Validity and reliability were examined using the radiographs of operations performed by orthopaedic resident participants (n = 28) of a multicentre randomized controlled educational trial (ISRCTN20431944). Trainees were divided into novice and intermediate groups, defined as having performed < ten or ≥ ten cases each for DHS and hemiarthroplasty at baseline. The procedure-based assessment (PBA) global rating score was assumed as the gold standard assessment for the purposes of concurrent validity. Intra- and inter-rater reliability testing were performed on a random subset of 25 cases.
Results


In total, 327 DHS and 248 hemiarthroplasty procedures were performed by 28 postgraduate year (PGY) 3 to 5 orthopaedic trainees during the 2014 to 2015 surgical training year at nine NHS hospitals in the West Midlands, UK. Overall, 109 PBAs were completed for DHS and 80 for hemiarthroplasty. Expert consensus identified four 'final product analysis' (FPA) radiological parameters of technical success for DHS: tip-apex distance (TAD); lag screw position in the femoral head; flushness of the plate against the lateral femoral cortex; and eight-cortex hold of the plate screws. Three parameters were identified for hemiarthroplasty: leg length discrepancy; femoral stem alignment; and femoral offset. Face validity, content validity, and feasibility were excellent. For all measurements, performance was better in the intermediate compared with the novice group, and this was statistically significant for TAD (p < 0.001) and femoral stem alignment (p = 0.023). Concurrent validity was poor when measured against global PBA score. This may be explained by the fact that they are measuring difference facets of competence. Intra-and inter-rater reliability were excellent for TAD, moderate for lag screw position (DHS), and moderate for leg length discrepancy (hemiarthroplasty). Use of a large multicentre dataset suggests good generalizability of the results to other settings. Assessment using FPA was time- and cost-effective compared with PBA.
Conclusion


Final product analysis using post-implantation radiographs to measure technical skill in hip fracture surgery is feasible, valid, reliable, and cost-effective. It can complement traditional workplace-based assessment for measuring performance in the real-world operating room . It may have particular utility in competency-based training frameworks and for assessing skill transfer from the simulated to live operating theatre.Cite this article:  Bone Joint Open  2020;1-9:594-604.",2020,"Intra-and inter-rater reliability were excellent for TAD, moderate for lag screw position (DHS), and moderate for leg length discrepancy (hemiarthroplasty).","['hip fracture surgery using the postoperative radiograph', 'In total, 327 DHS and 248 hemiarthroplasty procedures were performed by 28 postgraduate year (PGY) 3 to 5 orthopaedic trainees during the 2014 to 2015 surgical training year at nine NHS hospitals in the West Midlands, UK']","['Delphi exercise', 'FPA']","['Validity and reliability', 'TAD', 'Face validity, content validity, and feasibility', 'TAD, moderate for lag screw position (DHS), and moderate for leg length discrepancy (hemiarthroplasty', 'femoral stem alignment', 'procedure-based assessment (PBA) global rating score', 'global PBA score']","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454882', 'cui_str': 'West Midlands'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0042284', 'cui_str': 'Face Validity'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0023221', 'cui_str': 'Leg length inequality'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",3.0,0.0245869,"Intra-and inter-rater reliability were excellent for TAD, moderate for lag screw position (DHS), and moderate for leg length discrepancy (hemiarthroplasty).","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'James', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Giles T R', 'Initials': 'GTR', 'LastName': 'Pattison', 'Affiliation': 'Department of Trauma & Orthopaedic Surgery, University Hospitals Coventry & Warwickshire, Coventry, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Griffin', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Fisher', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Damian R', 'Initials': 'DR', 'LastName': 'Griffin', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, UK.'}]",Bone & joint open,['10.1302/2633-1462.19.BJO-2020-0101.R1']
2630,33215209,The effect of spironolactone on cardiovascular function and markers of fibrosis in people at increased risk of developing heart failure: the heart 'OMics' in AGEing (HOMAGE) randomized clinical trial.,"AIMS 


To investigate the effects of spironolactone on fibrosis and cardiac function in people at increased risk of developing heart failure.
METHODS AND RESULTS 


Randomized, open-label, blinded-endpoint trial comparing spironolactone (50 mg/day) or control for up to 9 months in people with, or at high risk of, coronary disease and raised plasma B-type natriuretic peptides. The primary endpoint was the interaction between baseline serum galectin-3 and changes in serum procollagen type-III N-terminal pro-peptide (PIIINP) in participants assigned to spironolactone or control. Procollagen type-I C-terminal pro-peptide (PICP) and collagen type-1 C-terminal telopeptide (CITP), reflecting synthesis and degradation of type-I collagen, were also measured. In 527 participants (median age 73 years, 26% women), changes in PIIINP were similar for spironolactone and control [mean difference (mdiff): -0.15; 95% confidence interval (CI) -0.44 to 0.15 μg/L; P = 0.32] but those receiving spironolactone had greater reductions in PICP (mdiff: -8.1; 95% CI -11.9 to -4.3 μg/L; P < 0.0001) and PICP/CITP ratio (mdiff: -2.9; 95% CI -4.3 to -1.5; <0.0001). No interactions with serum galectin were observed. Systolic blood pressure (mdiff: -10; 95% CI -13 to -7 mmHg; P < 0.0001), left atrial volume (mdiff: -1; 95% CI -2 to 0 mL/m2; P = 0.010), and NT-proBNP (mdiff: -57; 95% CI -81 to -33 ng/L; P < 0.0001) were reduced in those assigned spironolactone.
CONCLUSIONS 


Galectin-3 did not identify greater reductions in serum concentrations of collagen biomarkers in response to spironolactone. However, spironolactone may influence type-I collagen metabolism. Whether spironolactone can delay or prevent progression to symptomatic heart failure should be investigated.",2020,"Systolic blood pressure (mdiff: -10; 95% CI -13 to -7 mmHg; P < 0.0001), left atrial volume (mdiff: -1; 95% CI -2 to 0 ","['527 participants (median age 73\u2009years, 26% women', 'people with, or at high risk of, coronary disease and raised plasma B-type natriuretic peptides', 'people at increased risk of developing heart failure']","['spironolactone', 'Procollagen type-I C-terminal pro-peptide (PICP) and collagen type-1 C-terminal telopeptide (CITP']","['interaction between baseline serum galectin-3 and changes in serum procollagen type-III N-terminal pro-peptide (PIIINP', 'fibrosis and cardiac function', 'cardiovascular function and markers of fibrosis', 'Systolic blood pressure', 'PICP', 'left atrial volume']","[{'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]","[{'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033240', 'cui_str': 'Procollagen Type III'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0072052', 'cui_str': 'procollagen type I carboxy terminal peptide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",527.0,0.429367,"Systolic blood pressure (mdiff: -10; 95% CI -13 to -7 mmHg; P < 0.0001), left atrial volume (mdiff: -1; 95% CI -2 to 0 ","[{'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary, Glasgow G12 8QQ, UK.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, U1116, France.""}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Mariottoni', 'Affiliation': 'Department of Cardiology, Cortona Hospital, Arezzo, Italy.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary, Glasgow G12 8QQ, UK.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Cuthbert', 'Affiliation': 'Department of Cardiology, University of Hull, Castle Hill Hospital, Cottingham, East Riding of Yorkshire, UK.'}, {'ForeName': 'Job A J', 'Initials': 'JAJ', 'LastName': 'Verdonschot', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Petutschnigg', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin Institute of Health (BIH), and German Centre for Cardiovascular research (DZHK), Partner Site Berlin, Germany.'}, {'ForeName': 'Fozia Z', 'Initials': 'FZ', 'LastName': 'Ahmed', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, UK.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cosmi', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, U1116, France.""}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Brunner La Rocca', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Mamas A', 'Initials': 'MA', 'LastName': 'Mamas', 'Affiliation': 'Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, UK.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Department of Cardiology, University of Hull, Castle Hill Hospital, Cottingham, East Riding of Yorkshire, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin Institute of Health (BIH), and German Centre for Cardiovascular research (DZHK), Partner Site Berlin, Germany.'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Charité University Medicine Berlin, Berlin Institute of Health (BIH), and German Centre for Cardiovascular research (DZHK), Partner Site Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary, Glasgow G12 8QQ, UK.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'McDonald', 'Affiliation': ""St. Vincent's University Healthcare Group, and School of Medicine, University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Rouet', 'Affiliation': 'Equipe obésité et insuffisance cardiaque, Université UPS, Inserm I2MC, Toulouse, UMR 1048, France.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Staessen', 'Affiliation': 'Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Blerim', 'Initials': 'B', 'LastName': 'Mujaj', 'Affiliation': 'Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Program of Cardiovascular Diseases, CIMA. Universidad de Navarra and IdiSNA, Pamplona, Spain CIBERCV, Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diez', 'Affiliation': 'Program of Cardiovascular Diseases, CIMA. Universidad de Navarra and IdiSNA, Pamplona, Spain CIBERCV, Carlos III Institute of Health, Madrid, Spain.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Heymans', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center, the Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Latini', 'Affiliation': 'Department of Cardiovascular Medicine, Istituto di Ricerche Farmacologiche ""Mario Negri"" - IRCCS, Milan, Italy.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Grojean', 'Affiliation': 'Fondation Force, Research and Consulting Department, EDDH, Centre de Médecine Préventive, Rue du Doyen Jacques Parisot, Vandoeuvre les Nancy, 54500, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pizard', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, U1116, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girerd', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, U1116, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, U1116, France.""}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Collier', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, U1116, France.""}]",European heart journal,['10.1093/eurheartj/ehaa758']
2631,33215265,Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled Trial.,"Tongue-strengthening exercises (TSE) using a device have been proposed as an intervention for improving tongue strength and endurance. However, devices for TSE have been expensive and difficult to manipulate and are not commonly used in home or clinical settings. This study therefore aimed to investigate whether tongue-strengthening self-exercises (TSsE) using a tongue-strengthening self-exercise tool at home can improve tongue strength in healthy older adults. This study included 27 participants (exercise group, η = 16, 7 men, 9 women, median age 84.5 years; control group, n = 11, 2 men, 9 women, median age 79.0 years). Exercises in the exercise group consisted of pushing the anterior tongue against the hard palate 30 times, 3 times a day, 5 days a week, for 8 weeks using a tongue-strengthening self-exercise tool. This tool is available in five levels of hardness. The most suitable hardness of the tool for each participant was calculated based on 60% of maximum tongue pressure (MTP) during the first 2 weeks of the training period and 80% of MTP for the remainder of the training period, as assessed using a tongue pressure-measuring device. The exercise group showed a significant improvement of 4.1 kPa in MTP (an 11.53% increase) and 4.53 s in endurance of tongue pressure (ETP) (a 99.86% increase). Furthermore, adherence in the exercise group was 99.2%. In conclusion, performing TSsE for 8 weeks was effective for increasing MTP and ETP in healthy older adults. This indicates that TSsE may be useful in older individuals at home to prevent age-related tongue muscle weakness.",2020,The exercise group showed a significant improvement of 4.1 kPa in MTP (an 11.53% increase) and 4.53 s in endurance of tongue pressure (ETP) (a 99.86% increase).,"['Healthy Older Adults', 'older individuals at home to prevent age-related tongue muscle weakness', '27 participants (exercise group, η\u2009=\u200916, 7 men, 9 women, median age 84.5\xa0years; control group, n\u2009=\u200911, 2 men, 9 women, median age 79.0\xa0years', 'healthy older adults']","['Tongue-Strengthening Self-Exercises', 'TSsE', 'Tongue-strengthening exercises (TSE', 'tongue-strengthening self-exercises (TSsE', 'TSE']","['endurance of tongue pressure (ETP', 'tongue strength', '4.1\xa0kPa in MTP']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",27.0,0.0458425,The exercise group showed a significant improvement of 4.1 kPa in MTP (an 11.53% increase) and 4.53 s in endurance of tongue pressure (ETP) (a 99.86% increase).,"[{'ForeName': 'Jitsuro', 'Initials': 'J', 'LastName': 'Yano', 'Affiliation': 'Department of Speech-Language Pathology and Audiology, Faculty of Rehabilitation, Kawasaki University of Medical Welfare, 288 Matsushima, Kurashiki, Okayama, 701-0193, Japan. yano@mw.kawasaki-m.ac.jp.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nagami', 'Affiliation': 'Department of Speech-Language Pathology and Audiology, Faculty of Rehabilitation, Kawasaki University of Medical Welfare, 288 Matsushima, Kurashiki, Okayama, 701-0193, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Division of Speech-Language-Hearing Therapy, Rehabilitation Center, Kawasaki Medical School Hospital, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Division of Speech-Language-Hearing Therapy, Rehabilitation Center, Kawasaki Medical School General Medical Center, 2-6-1 Nakasange, Kita-ku, Okayama, 700-8505, Japan.'}, {'ForeName': 'Miyu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Preventive Rehabilitation, Kurashiki Heisei Hospital, 4-4-7 Oimatsu-cho, Kurashiki, Okayama, 710-0826, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Odan', 'Affiliation': 'Department of Preventive Rehabilitation, Kurashiki Heisei Hospital, 4-4-7 Oimatsu-cho, Kurashiki, Okayama, 710-0826, Japan.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Hikasa', 'Affiliation': 'Department of Day Care Rehabilitation, Kurashiki Geriatric Health Services Facilities, 4-4-7 Oimatsu-cho, Kurashiki, Okayama, 710-0826, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Hanayama', 'Affiliation': 'Department of Rehabilitation Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Speech-Language Pathology and Audiology, Faculty of Rehabilitation, Kawasaki University of Medical Welfare, 288 Matsushima, Kurashiki, Okayama, 701-0193, Japan.'}]",Dysphagia,['10.1007/s00455-020-10216-w']
2632,33215669,Gait Retraining Improves Running Impact Loading and Function in Previously Injured U.S. Military Cadets: A Pilot Study.,"INTRODUCTION


Running-related musculoskeletal injury (RRI) among U.S. military service members continues to negatively impact force readiness. There is a paucity of evidence supporting the use of RRI interventions, such as gait retraining, in military populations. Gait retraining has demonstrated effectiveness in altering running biomechanics and reducing running load. The purpose of this pilot study was to investigate the clinical effect of a gait retraining intervention on a military cadet population recovering from a lower-extremity RRI.
MATERIALS AND METHODS


The study design is a pilot study. Before study initiation, institutional approval was granted by the Keller Army Community Hospital Office of Human Research Protections. Nine rearfoot strike (RFS) runners recovering from a lower-extremity RRI at the U.S. Military Academy were prospectively enrolled and completed a gait retraining intervention. Participants followed-up with their assigned medical provider 6 times over 10 weeks for a clinical evaluation and running gait retraining. Gait retraining was provided utilizing verbal, visual, and audio feedback to facilitate a change in running foot strike pattern from RFS to non-rearfoot strike (NRFS) and increase preferred running step rate. At pre-intervention and post-intervention running ground reaction forces (GRF) [average vertical loading rate (AVLR), peak vertical GRF], kinematic (foot strike pattern) and temporospatial (step rate, contact time) data were collected. Participants self-reported their level of function via the Single Assessment Numeric Evaluation, Patient-Specific Functional Scale, and total weekly running minutes. Paired samples t-tests and Wilcoxon signed rank tests were used to compare pre- and post-intervention measures of interest. Values of P < .05 were considered statistically significant.
RESULTS


Nine patients completed the 10-week intervention (age, 20.3 ± 2.2 years; height, 170.7 ± 13.8 cm; mass, 71.7 ± 14.9 kg; duration of injury symptoms, 192.4 ± 345.5 days; running speed, 2.8 ± 0.38 m/s). All nine runners (100%) transitioned from RFS to NRFS. Left AVLR significantly decreased from 60.3 ± 17.0 bodyweight per second (BW/s) before intervention to 25.9 ± 9.1 BW/s after intervention (P = 0.008; effect size (d) = 2.5). Right AVLR significantly decreased from 60.5 ± 15.7 BW/s to 32.3 ± 12.5 BW/s (P < .001; d = 2.0). Similarly, step rate increased from 169.9 ± 10.0 steps per minute (steps/min) before intervention to 180.5 ± 6.5 steps/min following intervention (P = .005; d = 1.3). Single Assessment Numeric Evaluation scores improved significantly from 75 ± 23 to 100 ± 8 (P = .008; d = 1.5) and Patient-Specific Functional Scale values significantly improved from 6 ± 2.3 to 9.5 ± 1.6 (P = .007; d = 1.8) after intervention. Peak vertical GRF (left, P = .127, d = 0.42; right, P = .052, d = 0.53), contact time (left, P = 0.127, d = 0.42; right, P = 0.052, d = 0.53), and total weekly continuous running minutes (P = 0.095, d = 0.80) remained unchanged at post-intervention. All 9 patients remained injury free upon a 6-month medical record review.
CONCLUSIONS


In 9 military service members with a RRI, a 10-week NRFS gait retraining intervention was effective in improving running mechanics and measures of function. Patients remained injury-free 6 months following enrollment. The outcomes of this pilot study suggest that individuals recovering from certain lower-extremity RRIs may benefit from transitioning to an NRFS running pattern.",2020,Single Assessment Numeric Evaluation scores improved significantly from 75 ± 23 to 100 ± 8 (P = .008; d = 1.5) and Patient-Specific Functional Scale values significantly improved from 6 ± 2.3 to 9.5 ± 1.6 (P = .007; d = 1.8) after intervention.,"['All 9 patients remained injury free upon a 6-month medical record review', 'Nine patients completed the 10-week intervention (age, 20.3\u2009±\u20092.2 years; height, 170.7\u2009±\u200913.8 cm; mass, 71.7\u2009± 14.9 kg; duration of injury symptoms, 192.4\u2009±\u2009345.5 days; running speed, 2.8\u2009±\u20090.38 m/s', 'Nine rearfoot strike (RFS) runners recovering from a lower-extremity RRI at the U.S. Military Academy', 'military cadet population recovering from a lower-extremity RRI', '9 military service members with a RRI']","['NRFS gait retraining intervention', 'clinical evaluation and running gait retraining', 'gait retraining intervention', 'Gait retraining was provided utilizing verbal, visual, and audio feedback to facilitate a change in running foot strike pattern from RFS to non-rearfoot strike (NRFS', 'Gait retraining', 'Gait Retraining']","['level of function via the Single Assessment Numeric Evaluation, Patient-Specific Functional Scale, and total weekly running minutes', 'Right AVLR', 'step rate', 'contact time', 'Patient-Specific Functional Scale values', 'Peak vertical GRF', 'vertical loading rate (AVLR), peak vertical GRF], kinematic (foot strike pattern) and temporospatial (step rate, contact time) data', 'Left AVLR', 'Single Assessment Numeric Evaluation scores', 'running mechanics and measures of function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4517456', 'cui_str': '0.38'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2936182', 'cui_str': 'Audio Feedback'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",9.0,0.0503972,Single Assessment Numeric Evaluation scores improved significantly from 75 ± 23 to 100 ± 8 (P = .008; d = 1.5) and Patient-Specific Functional Scale values significantly improved from 6 ± 2.3 to 9.5 ± 1.6 (P = .007; d = 1.8) after intervention.,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Keller Army Community Hospital Division I Sports Physical Therapy Fellowship, Keller Army Community Hospital, West Point, NY 10996, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Crowell', 'Affiliation': 'Keller Army Community Hospital Division I Sports Physical Therapy Fellowship, Keller Army Community Hospital, West Point, NY 10996, USA.'}, {'ForeName': 'Jamie B', 'Initials': 'JB', 'LastName': 'Morris', 'Affiliation': 'Army-Baylor Doctorate of Physical Therapy Program, United States Army Medical Center of Excellence,Fort Sam Houston, TX 78234, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Mason', 'Affiliation': 'Keller Army Community Hospital Division I Sports Physical Therapy Fellowship, Keller Army Community Hospital, West Point, NY 10996, USA.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Zifchock', 'Affiliation': 'Department of Civil and Mechanical Engineering, United States Military Academy, West Point, NY 10996, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Goss', 'Affiliation': 'Department of Physical Therapy, One University Parkway, High Point University, High Point, NC 27268, USA.'}]",Military medicine,['10.1093/milmed/usaa383']
2633,33215681,Spatiotemporal and Kinematic Comparisons Between Anthropometrically Paired Male and Female Soldiers While Walking With Heavy Loads.,"INTRODUCTION


Limited work comparing the effect of heavier carried loads (greater than 30 kg) between men and women has attributed observed differences to sex with the possibility that anthropometric differences may have contributed to those discrepancies. With the recent decision permitting women to enter Combat Arms roles, knowledge of sex-based differences in gait response to load carriage is more operationally relevant, as military loads are absolute and not relative to body weight. The purpose of this study was to describe differences in gait parameters at light to heavy loads between anthropometrically similar male and female soldiers.
MATERIALS AND METHODS


Eight female and 8 male soldiers, frequency-matched (1-to-1) on height (±0.54 cm) and mass (±0.52 kg), walked at 1.34 m∙s-1 for 10-min bouts on a level treadmill while unloaded (BM) and then carrying randomized vest-borne loads of 15, 35, and 55 kg. Spatiotemporal and kinematic data were collected for 30 s after 5 min. Two-way repeated measures analyses of variance were conducted to compare the gait parameter variables between sexes at each load.
RESULTS


As load increased, overall, the percent double support increased, step frequency increased, stride length decreased, hip and ankle range of motion (ROM) increased, and vertical center of mass (COM) displacement increased. Sex-based significant differences were observed in knee ROM and mediolateral COM displacement. Among the male participants, knee ROM increased significantly for all loads greater than BM. For mediolateral COM displacement, male remained constant as load increased, whereas female values decreased between BM and 35 kg.
CONCLUSIONS


Spatiotemporal and kinematic differences in gait parameters were primarily because of increases in load magnitude. The observed sex-related differences with increasing loads suggest that women may require a more stable gait to support the additional load carried.",2020,"As load increased, overall, the percent double support increased, step frequency increased, stride length decreased, hip and ankle range of motion (ROM) increased, and vertical center of mass (COM) displacement increased.","['Anthropometrically Paired Male and Female Soldiers', 'Eight female and 8 male soldiers, frequency-matched (1-to-1) on height (±0.54 cm) and mass (±0.52 kg), walked at 1.34 m∙s-1 for 10-min bouts on a level treadmill while unloaded (BM) and then carrying randomized vest-borne loads of 15, 35, and 55 kg']",[],"['stride length decreased, hip and ankle range of motion (ROM) increased, and vertical center of mass (COM) displacement', 'knee ROM and mediolateral COM displacement', 'knee ROM']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4517501', 'cui_str': '1.34'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}]",,0.0514511,"As load increased, overall, the percent double support increased, step frequency increased, stride length decreased, hip and ankle range of motion (ROM) increased, and vertical center of mass (COM) displacement increased.","[{'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Bode', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Peter N', 'Initials': 'PN', 'LastName': 'Frykman', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Nathaniel I', 'Initials': 'NI', 'LastName': 'Smith', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Fellin', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Seay', 'Affiliation': 'Military Performance Division, United States Army Research Institute of Environmental Medicine, Natick, MA 01760, USA.'}]",Military medicine,['10.1093/milmed/usaa435']
2634,33215715,Heightened sensitivity to the caregiving environment during adolescence: implications for recovery following early-life adversity.,"BACKGROUND


Adolescence has been proposed to be a period of heightened sensitivity to environmental influence. If true, adolescence may present a window of opportunity for recovery for children exposed to early-life adversity. Recent evidence supports adolescent recalibration of stress response systems following early-life adversity. However, it is unknown whether similar recovery occurs in other domains of functioning in adolescence.
METHODS


We use data from the Bucharest Early Intervention Project - a randomized controlled trial of foster care for children raised in psychosocially depriving institutions - to examine the associations of the caregiving environment with reward processing, executive functioning, and internalizing and externalizing psychopathology at ages 8, 12, and 16 years, and evaluate whether these associations change across development.
RESULTS


Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment. The associations of caregiving with executive function and internalizing and externalizing symptoms varied by age and were strongest at age 16 relative to ages 8 and 12 years. This heightened sensitivity to caregiving in adolescence was observed in both children with and without exposure to early psychosocial neglect.
CONCLUSIONS


Adolescence may be a period of heightened sensitivity to the caregiving environment, at least for some domains of functioning. For children who experience early psychosocial deprivation, this developmental period may be a window of opportunity for recovery of some functions. Albeit correlational, these findings suggest that it may be possible to reverse or remediate some of the lasting effects of early-life adversity with interventions that target caregiving during adolescence.",2020,"Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment.",['varied by age and were strongest at age 16 relative to ages 8 and 12\xa0years'],[],"['reward responsivity and lower levels of internalizing and externalizing symptoms', 'caregiving with executive function and internalizing and externalizing symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.128357,"Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment.","[{'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Colich', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Sheridan', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Humphreys', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Tibu', 'Affiliation': 'Department of Research, Institute for Child Development, Bucharest, Romania.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Psychology, Harvard University, Boston, MA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13347']
2635,33215755,Factors Affecting Implant Stability Quotients At Immediately and Conventionally Loaded Implants In The Posterior Maxilla: A Split-Mouth Randomized Controlled Trial.,"PURPOSE


To assess primary and secondary stability of variable-thread tapered implants in the posterior maxilla and analyze the impact of various factors on implant stability quotients (ISQs).
MATERIALS AND METHODS


Twenty six subjects received 3-4 adjacent implants in the maxillary premolar-molar sextants to replace bilateral tooth loss. The implants on one side were immediately loaded with a provisional fixed prosthesis regardless of their primary stability. The contralateral control implants were conventionally loaded. Bone quality was subjectively recorded and primary stability was assessed by means of insertion torque values (ITVs) and ISQs in 4 directions. Secondary stability was measured by ISQ at definitive prosthesis delivery (3 to 3.5 months postoperatively), and 12 months after definitive loading. The impact of measurement direction, loading protocol, time, site-related (bone quality, implant position, crestal buccal bone thickness, apical cortical anchorage), and implant-related (implant dimensions, abutment height) variables on ISQs was assessed.
RESULTS


For logistic reasons, ISQs were obtained for only 18 patients with 60 test and 60 control implants. Most of the implants (82%) at baseline had their lowest ISQ on the buccal aspect. There were no significant differences between ISQs measured in the buccal and palatal directions, or between ISQs in the mesial and distal directions. The mean of buccal and palatal ISQs was significantly lower than the mean of the 2 interproximal measurements at all evaluation periods. ISQs were not significantly different between the 2 loading groups at any time point. All implants showed a time-dependent increase in ISQs. Baseline ISQ correlated weakly with bone quality and ITV. None of the variables had a significant impact on baseline ISQs, except for implants in second molar sites which showed poorer primary stability than first premolars.
CONCLUSION


measurement direction and time are the most significant parameters affecting ISQs of variable-thread tapered implants in the posterior maxilla. This article is protected by copyright. All rights reserved.",2020,"None of the variables had a significant impact on baseline ISQs, except for implants in second molar sites which showed poorer primary stability than first premolars.
","['18 patients with 60 test and 60 control implants', 'Twenty six subjects received 3-4 adjacent implants in the maxillary premolar-molar sextants to replace bilateral tooth loss']",['Conventionally Loaded Implants'],"['baseline ISQs', 'ISQs', 'Bone quality', 'measurement direction, loading protocol, time, site-related (bone quality, implant position, crestal buccal bone thickness, apical cortical anchorage), and implant-related (implant dimensions, abutment height) variables on ISQs', 'insertion torque values (ITVs) and ISQs', 'Implant Stability Quotients', 'mean of buccal and palatal ISQs', 'implant stability quotients (ISQs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1609514', 'cui_str': 'Palatal implant'}]",,0.18766,"None of the variables had a significant impact on baseline ISQs, except for implants in second molar sites which showed poorer primary stability than first premolars.
","[{'ForeName': 'Fadi I', 'Initials': 'FI', 'LastName': 'Daher', 'Affiliation': 'Department of Periodontics, Lebanese University, Faculty of Dental Medicine, Hadath, Lebanon.'}, {'ForeName': 'Habib L', 'Initials': 'HL', 'LastName': 'Abi-Aad', 'Affiliation': 'Department of Periodontics, Lebanese University, Faculty of Dental Medicine, Hadath, Lebanon.'}, {'ForeName': 'Hani I', 'Initials': 'HI', 'LastName': 'Dimassi', 'Affiliation': 'School of Pharmacy, Department of Pharmaceutical Sciences, Lebanese American University, Byblos, Lebanon.'}, {'ForeName': 'Nadim Z', 'Initials': 'NZ', 'LastName': 'Baba', 'Affiliation': 'Advanced Dental Education Program in Implant Dentistry, Loma Linda University, School of Dentistry, Loma Linda, CA.'}, {'ForeName': 'Zeina Ak', 'Initials': 'ZA', 'LastName': 'Majzoub', 'Affiliation': 'Department of Periodontics, Lebanese University, Faculty of Dental Medicine, Hadath, Lebanon.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13296']
2636,33215762,Long-Term Safety and Clinical Effects of Nilotinib in Parkinson's Disease.,"BACKGROUND


Nilotinib is US Food and Drug Administration-approved for leukemia, and this open-label study investigated the safety, tolerability, and potential clinical effects of nilotinib in medically optimized patients with Parkinson's disease.
OBJECTIVES


Safety and tolerability were the primary objectives, and clinical outcomes were exploratory.
METHODS


A total of 63 patients completed a 15-month phase 2, double-blind, placebo-controlled study and were rerandomized 1:1 into an open-label study of nilotinib 150 mg versus 300 mg for 12 months.
RESULTS


Nilotinib was safe and tolerated, and no adverse effects seemed to be related to the drug, and no differences in adverse events were observed between groups. Exploratory clinical outcomes showed that nilotinib 300 mg was remarkably stable from baseline to 27 months using partial and total Unified Parkinson's Disease Scale (UPDRS). Nilotinib 150 mg versus 300 mg, significantly declined using partial or the sum of UPDRS Parts I and II. There was no significant difference in nilotinib 150 mg versus 300 mg using UPDRS Part III (on levodopa) and total UPDRS Parts I to III. Subgroup analysis showed that late-start nilotinib 150 mg significantly worsened using the sum of UPDRS Parts II + III and total UPDRS Parts I to III compared with late-start nilotinib 300 mg. Quality of life using the Parkinson's Disease Questionnaire in nilotinib 150 mg significantly declined between 15 and 27 months compared with nilotinib 300 mg, and there was no change in cognition using the Montreal Cognitive Assessment between groups.
CONCLUSIONS


This study provides evidence that nilotinib is safe and tolerated in Parkinson's disease. The exploratory clinical data will inform an adequately powered larger study to evaluate the efficacy of nilotinib 300 mg in Parkinson's disease. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.",2020,"Quality of life using the Parkinson's Disease Questionnaire in nilotinib 150 mg significantly declined between 15 and 27 months compared with nilotinib 300 mg, and there was no change in cognition using the Montreal Cognitive Assessment between groups.
","['63 patients', ""medically optimized patients with Parkinson's disease"", '2020', ""Parkinson's Disease""]","['nilotinib 150\u2009mg versus 300\u2009mg for 12\u2009months', 'placebo']","['cognition using the Montreal Cognitive Assessment', 'safe and tolerated', ""Quality of life using the Parkinson's Disease Questionnaire"", 'adverse events', 'UPDRS Parts II\u2009+\u2009III and total UPDRS Parts', ""partial and total Unified Parkinson's Disease Scale (UPDRS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C2920193', 'cui_str': 'nilotinib 150 MG'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",63.0,0.0238923,"Quality of life using the Parkinson's Disease Questionnaire in nilotinib 150 mg significantly declined between 15 and 27 months compared with nilotinib 300 mg, and there was no change in cognition using the Montreal Cognitive Assessment between groups.
","[{'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Pagan', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wilmarth', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Ferrante', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, District of Columbia, USA.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, District of Columbia, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28389']
2637,33216010,The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.,"BACKGROUND


Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.
OBJECTIVE


In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial.
METHODS


In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463).
RESULTS


Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021.
CONCLUSIONS


The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18929.",2020,"Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email).","['2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline', 'older adults', 'Older Adults']","['Active Brains intervention, a web-based digital intervention', 'usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email']","['cognitive health', 'performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia', 'depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0086850', 'cui_str': 'Process Measures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",,0.22396,"Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email).","[{'ForeName': 'Kirsten Ailsa', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bradbury', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Essery', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Pollet', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Mowbray', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Slodkowska-Barabasz', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Denison-Day', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hayter', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Somerville', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Grey', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Western', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Ferrey', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Krusche', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Physical Activity for Health Research Centre, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'NIHR Newcastle Biomedical Research Centre, Newcastle University and Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Guiqing Lily', 'Initials': 'GL', 'LastName': 'Yao', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Robinson', 'Affiliation': 'Institute of Population Health Sciences, University of Newcastle, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, University College London, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gallacher', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Kendrick', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Shanaya', 'Initials': 'S', 'LastName': 'Rathod', 'Affiliation': 'Southern Health NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gudgin', 'Affiliation': 'Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Stokes', 'Affiliation': 'Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Niven', 'Affiliation': 'Public and Patient Involvement (PPI) representative, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Centre for Community and Clinical Applications of Health Psychology, University of Southampton, Southampton, United Kingdom.'}]",JMIR research protocols,['10.2196/18929']
2638,33216012,A pilot study of mindfulness-based relapse prevention for compulsive sexual behaviour disorder.,"Background and aims


Compulsive sexual behaviour disorder (CSBD) is a medical condition that can impair social and occupational functioning and lead to severe distress. To date, treatment effectiveness studies of CSBD are under-developed; typically, treatment for CSBD is based on guidelines for substance or other behavioural addictions. Mindfulness-based relapse prevention (MBRP) is an evidence-based treatment for substance addiction aimed at, among other things, reducing craving and negative affect-i.e. processes that are implicated in the maintenance of problematic sexual behaviours. However, to our knowledge no prior research has been published evaluating mindfulness-based intervention (MBI) in the treatment of CSBD, except two clinical case reports. Therefore, the aim of the current pilot study was to examine whether MBRP can lead to clinical improvement in CSBD. Methods: Participants were 13 adult males with a diagnosis of CSBD. Before and after the eight-week MBRP intervention, participants completed a booklet of questionnaires including measurements of porn viewing, masturbation and emotional distress. Results: As expected, we found that after MBRP participants spent significantly less time engaging in problematic pornography use and exhibited a decrease in anxiety, depression and obsessive-compulsive (OC) symptoms. Discussion and Conclusions: The findings indicate that MBRP could be beneficial for CSBD individuals. Further clinical effectiveness studies with bigger sample sizes, delayed post-training measurements and randomised control trial design are warranted. In conclusion, MBRP leads to a decrease in time spent watching porn and a decrease in emotional distress in CSBD patients.",2020,"In conclusion, MBRP leads to a decrease in time spent watching porn and a decrease in emotional distress in CSBD patients.","['CSBD patients', 'Participants were 13 adult males with a diagnosis of CSBD', 'compulsive sexual behaviour disorder']","['MBRP', 'Mindfulness-based relapse prevention (MBRP', 'mindfulness-based relapse prevention']","['anxiety, depression and obsessive-compulsive (OC) symptoms', 'time spent watching porn', 'emotional distress']","[{'cui': 'C2242574', 'cui_str': 'Compulsive sexual behaviour'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444864', 'cui_str': 'AM 13'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",13.0,0.0466187,"In conclusion, MBRP leads to a decrease in time spent watching porn and a decrease in emotional distress in CSBD patients.","[{'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Holas', 'Affiliation': '1Faculty of Psychology, University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Draps', 'Affiliation': '2Institute of Psychology, Polish Academy of Sciences, Warsaw, Poland.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Kowalewska', 'Affiliation': '3Department of Psychiatry, Centre of Postgraduate Medical Education, Warsaw, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Lewczuk', 'Affiliation': '4Institute of Psychology, Cardinal Stefan Wyszynski University, Warsaw, Poland.'}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Gola', 'Affiliation': '2Institute of Psychology, Polish Academy of Sciences, Warsaw, Poland.'}]",Journal of behavioral addictions,['10.1556/2006.2020.00075']
2639,33216013,Treatment outcomes of a CBT-based group intervention for adolescents with Internet use disorders.,"Background and aims


Instances of Internet use disorders (IUD) including Internet gaming disorder (IGD) and non-gaming pathological Internet use (ng-PIU) have the extent that they are now a growing mental health issue. Individuals suffering from IUD show a large range of symptoms, high comorbidities and impairments in different areas of life. To date there is a lack of efficient and evidence-based treatment programs for such adolescents. The present registered single-arm trial (ClinicalTrials.gov: NCT03582839) aimed to investigate the long-term effects of a brief manualized cognitive behavioral therapy (CBT) program for adolescents with IUD.
Methods


N = 54 patients (16.7% female), aged 9-19 years (M = 13.48, SD = 1.72) received the CBT group program PROTECT+. IUD symptom severity (primary outcome variable) as well as comorbid symptoms, risk-related variables and potentially protective skills (secondary outcome variables) were assessed at pretest, posttest, as well as 4 and 12 months after admission.
Results


Patients showed a significant reduction in IUD symptom severity at the 12-month follow-up. Effect sizes were medium to large depending on the measure. Beyond the statistical significance, the clinical significance was confirmed using the reliable change index. Secondary outcome variables showed a significant reduction in self-reported depression, social anxiety, performance anxiety and school anxiety as well as in parental-reported general psychopathology.
Discussion and conclusions


The present study shows long-term effects of a manual-based CBT treatment for adolescents suffering from IUD. The results indicate that even a 4-session brief intervention can achieve a medium to large effect over 12 months. Future work is needed to confirm the efficacy within a randomized controlled trial (RCT).",2020,"Secondary outcome variables showed a significant reduction in self-reported depression, social anxiety, performance anxiety and school anxiety as well as in parental-reported general psychopathology.
","['adolescents with IUD', 'Methods\n\n\nN = 54 patients (16.7% female), aged 9-19 years (M = 13.48, SD = 1.72) received the', 'adolescents suffering from IUD', 'adolescents with Internet use disorders']","['CBT-based group intervention', 'manualized cognitive behavioral therapy (CBT) program', 'manual-based CBT treatment', 'CBT group program PROTECT', 'Internet gaming disorder (IGD) and non-gaming pathological Internet use (ng-PIU']","['self-reported depression, social anxiety, performance anxiety and school anxiety as well as in parental-reported general psychopathology', 'IUD symptom severity', 'comorbid symptoms, risk-related variables and potentially protective skills']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517590', 'cui_str': '16.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517513', 'cui_str': '1.72'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0458631', 'cui_str': 'Performance anxiety'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",54.0,0.111578,"Secondary outcome variables showed a significant reduction in self-reported depression, social anxiety, performance anxiety and school anxiety as well as in parental-reported general psychopathology.
","[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Szász-Janocha', 'Affiliation': '1Institute for Psychology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Vonderlin', 'Affiliation': '2Institute of Psychology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Katajun', 'Initials': 'K', 'LastName': 'Lindenberg', 'Affiliation': '1Institute for Psychology, Goethe University Frankfurt, Frankfurt, Germany.'}]",Journal of behavioral addictions,['10.1556/2006.2020.00089']
2640,33216026,Stressor-Oriented MUlticomponent Intervention and the WeLl-Being of Patients with Alzheimer's Disease: A Randomized Controlled Trial (SOUL-P).,"BACKGROUND


Patients with Alzheimer's disease (AD) experience various stressors that negatively impact well-being. Most studies have, however, small effect size and are limited by the experiences of severe patients. Therefore, we conducted a single-blind, randomized controlled trial, which has included patients at different stages.
OBJECTIVE


The stressor-oriented multicomponent program was designed as an intervention for AD patients to enhance well-being.
METHODS


Patients were randomly assigned to control or SOUL-P conditions according to disease severity. The SOUL-P group received 15 intensive sessions over 6 months and 6 maintenance sessions over a 6-month follow-up by a multidisciplinary team comprising psychologists, occupational therapists, and community nurses. The control group received a similar number of sessions by community nurses. Stress-related outcomes (primary stressors and well-being outcomes) were obtained from in-person baseline and follow-up interviews conducted at 6- and 12-months post-baseline. A treatment compliance survey was conducted at the intervention endpoint for patients.
RESULTS


Of the 863 patients screened, 218 (25.3%) were eligible. At 6 months, compared to controls, SOUL-P patients had improved quality of life (QoL) (p <  0.001; Cohen d = 0.56), depression (p = 0.020; Cohen d = -0.33), neurobehavioral symptoms (p = 0.034; Cohen d = -0.30), perceived stress (p = 0.030; Cohen d = -0.31), and family conflict (p = 0.026; Cohen d = -0.32). QoL, depression, perceived stress, and family conflict were still significantly different at 12 months. Most patients were satisfied with SOUL-P, while caregivers in the SOUL-P group reported overloading tasks.
CONCLUSION


SOUL-P may reduce perceived stress and improve psychological outcomes in AD patients. Stressor-based interventions, patient-oriented goals, and a multidisciplinary team are essential features for a successful SOUL-P.",2020,"QoL, depression, perceived stress, and family conflict were still significantly different at 12 months.","['863 patients screened, 218 (25.3%) were eligible', 'Patients', ""Patients with Alzheimer's disease (AD"", 'included patients at different stages', ""Patients with Alzheimer's Disease"", 'AD patients']",['Stressor-Oriented MUlticomponent Intervention'],"['psychological outcomes', 'depression', 'neurobehavioral symptoms', 'QoL, depression, perceived stress, and family conflict', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}]",,0.164958,"QoL, depression, perceived stress, and family conflict were still significantly different at 12 months.","[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Yunmei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Rehabilitation Department, the Affiliated Rehabilitation Hospital of Chongqing Medical University, Jiulongpo District, Chongqing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Gan', 'Affiliation': 'Psychiatry Department, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Geriatric Department, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Dengbi', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Community Health Center of Daxigou, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Yetao', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Clinical Epidemiology and Biostatistics Department, Children's Hospital affiliated with Chongqing Medical University, Chongqing, China.""}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Nursing Department, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200652']
2641,33216048,Oral Mucositis: Examining the Combined Solution of Grape Vinegar and Rose Water Versus Chlorhexidine Mouthwash.,"BACKGROUND


Studies have reported contradictory findings regarding the efficacy of chemical mouthwashes for chemotherapy-induced oral mucositis.
OBJECTIVES


This study sought to compare the effect of the combined solution of grape vinegar and rose water versus chlorhexidine mouthwash on chemotherapy-induced oral mucositis.
METHODS


60 patients were randomly assigned to either chlorhexidine or the vinegar and rose water solution. Fifty-three patients completed the study. Patients rinsed their mouths with mouthwash three times a day for 14 days.
FINDINGS


Chlorhexidine mouthwash and the grape vinegar and rose water solution decreased chemotherapy-induced oral mucositis. The therapeutic property of the grape vinegar and rose water solution was similar to that of chlorhexidine mouthwash in treating oral mucositis.
",2020,"The therapeutic property of the grape vinegar and rose water solution was similar to that of chlorhexidine mouthwash in treating oral mucositis.
","['60 patients', 'Fifty-three patients completed the study']","['Grape Vinegar and Rose Water Versus Chlorhexidine Mouthwash', 'chlorhexidine or the vinegar and rose water solution', 'chlorhexidine mouthwash', 'combined solution of grape vinegar and rose water versus chlorhexidine mouthwash']",['Oral Mucositis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018208', 'cui_str': 'Grapes'}, {'cui': 'C0148405', 'cui_str': 'Vinegar'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0352155', 'cui_str': 'Chlorhexidine Mouthwash'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",60.0,0.0578698,"The therapeutic property of the grape vinegar and rose water solution was similar to that of chlorhexidine mouthwash in treating oral mucositis.
","[{'ForeName': 'Ardashir', 'Initials': 'A', 'LastName': 'Afrasiabifar', 'Affiliation': 'Yasuj University of Medical Sciences.'}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Jafari Dehkordi', 'Affiliation': 'Yasuj University of Medical Sciences.'}, {'ForeName': 'Asadolah', 'Initials': 'A', 'LastName': 'Mosavi', 'Affiliation': 'Yasuj University of Medical Sciences.'}, {'ForeName': 'Mohammad Amin', 'Initials': 'MA', 'LastName': 'Nazer Mozaffari', 'Affiliation': 'Shahid Jalil Hospital Yasuj.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Ali Beigi Bani', 'Affiliation': 'High Institute for Research and Education in Transfusion Medicine.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.E71-E78']
2642,33219056,Prediction of relapse-free survival according to adjuvant chemotherapy and regulator of chromosome condensation 2 (RCC2) expression in colorectal cancer.,"BACKGROUND


There is a need for improved selection of patients for adjuvant chemotherapy after resection of non-metastatic colorectal cancer (CRC). Regulator of chromosome condensation 2 (RCC2) is a potential prognostic biomarker. We report on the establishment of a robust protocol for RCC2 expression analysis and prognostic tumour biomarker evaluation in patients who did and did not receive adjuvant chemotherapy.
MATERIALS AND METHODS


RCC2 was analysed in 2916 primary CRCs from the QUASAR2 randomised trial and two single-hospital Norwegian series. A new protocol using fluorescent antibody staining and digital image analysis was optimised. Biomarker value for 5-year relapse-free survival was analysed in relation to tumour stage, adjuvant chemotherapy and the molecular markers microsatellite instability,  KRAS / BRAF   V600E / TP53  mutations and  CDX2  expression.
RESULTS


Low RCC2 expression was scored in 41% of 2696 evaluable samples. Among patients with stage I-III CRC who had not received adjuvant chemotherapy, low RCC2 expression was an independent marker of inferior 5-year relapse-free survival in multivariable Cox models including clinicopathological factors and molecular markers (HR 1.45, 95% CI 1.09 to 1.94, p=0.012, N=521). RCC2 was not prognostic in patients who had received adjuvant chemotherapy, neither in QUASAR2 nor the pooled Norwegian series. The interaction between RCC2 and adjuvant chemotherapy for prediction of patient outcome was significant in stage III, and strongest among patients with microsatellite stable tumours (p interaction =0.028).
CONCLUSIONS


Low expression of RCC2 is a biomarker for poor prognosis in patients with stage I-III CRC and seems to be a predictive biomarker for effect of adjuvant chemotherapy.",2020,"RCC2 was not prognostic in patients who had received adjuvant chemotherapy, neither in QUASAR2 nor the pooled Norwegian series.","['patients for adjuvant chemotherapy after resection of non-metastatic colorectal cancer (CRC', 'patients who did and did not receive adjuvant chemotherapy', 'colorectal cancer', 'patients with stage I-III CRC', 'RCC2 was analysed in 2916 primary CRCs from the QUASAR2 randomised trial and two single-hospital Norwegian series']",['RCC2'],"['Low RCC2 expression', '5-year relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0205549', 'cui_str': 'Series'}]","[{'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0008633', 'cui_str': 'Chromosome'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.143082,"RCC2 was not prognostic in patients who had received adjuvant chemotherapy, neither in QUASAR2 nor the pooled Norwegian series.","[{'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Bergsland', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jarle', 'Initials': 'J', 'LastName': 'Bruun', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marianne G', 'Initials': 'MG', 'LastName': 'Guren', 'Affiliation': 'K.G. Jebsen Colorectal Cancer Research Centre, Clinic for Cancer Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Aud', 'Initials': 'A', 'LastName': 'Svindland', 'Affiliation': 'K.G. Jebsen Colorectal Cancer Research Centre, Clinic for Cancer Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Bjørnslett', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Smeby', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Hektoen', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kolberg', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Domingo', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Teijo', 'Initials': 'T', 'LastName': 'Pellinen', 'Affiliation': 'K.G. Jebsen Colorectal Cancer Research Centre, Clinic for Cancer Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Tomlinson', 'Affiliation': 'Cancer Research UK Edinburgh Centre, Institute of Genetics & Molecular Medicine, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Nuffield Division of Clinical Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Church', 'Affiliation': 'Cancer Genomics and Immunology Group, The Wellcome Centre for Human Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Arild', 'Initials': 'A', 'LastName': 'Nesbakken', 'Affiliation': 'K.G. Jebsen Colorectal Cancer Research Centre, Clinic for Cancer Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sveen', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ragnhild A', 'Initials': 'RA', 'LastName': 'Lothe', 'Affiliation': 'Department of Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway ragnhild.a.lothe@rr-research.no.'}]",ESMO open,['10.1136/esmoopen-2020-001040']
2643,33219115,Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial.,"OBJECTIVE


To compare the effectiveness of progressive tendon-loading exercises (PTLE) with eccentric exercise therapy (EET) in patients with patellar tendinopathy (PT).
METHODS


In a stratified, investigator-blinded, block-randomised trial, 76 patients with clinically diagnosed and ultrasound-confirmed PT were randomly assigned in a 1:1 ratio to receive either PTLE or EET. The primary end point was clinical outcome after 24 weeks following an intention-to-treat analysis, as assessed with the validated Victorian Institute of Sports Assessment for patellar tendons (VISA-P) questionnaire measuring pain, function and ability to play sports. Secondary outcomes included the return to sports rate, subjective patient satisfaction and exercise adherence.
RESULTS


Patients were randomised between January 2017 and July 2019. The intention-to-treat population (mean age, 24 years, SD 4); 58 (76%) male) consisted of patients with mostly chronic PT (median symptom duration 2 years). Most patients (82%) underwent prior treatment for PT but failed to recover fully. 38 patients were randomised to the PTLE group and 38 patients to the EET group. The improvement in VISA-P score was significantly better for PTLE than for EET after 24 weeks (28 vs 18 points, adjusted mean between-group difference, 9 (95% CI 1 to 16); p=0.023). There was a trend towards a higher return to sports rate in the PTLE group (43% vs 27%, p=0.13). No significant between-group difference was found for subjective patient satisfaction (81% vs 83%, p=0.54) and exercise adherence between the PTLE group and EET group after 24 weeks (40% vs 49%, p=0.33).
CONCLUSIONS


In patients with PT, PTLE resulted in a significantly better clinical outcome after 24 weeks than EET. PTLE are superior to EET and are therefore recommended as initial conservative treatment for PT.",2020,"No significant between-group difference was found for subjective patient satisfaction (81% vs 83%, p=0.54) and exercise adherence between the PTLE group and EET group after 24 weeks (40% vs 49%, p=0.33).
","['76 patients with clinically diagnosed and ultrasound-confirmed PT', 'patients with patellar tendinopathy', 'Patients were randomised between January 2017 and July 2019', 'The intention-to-treat population (mean age, 24 years, SD 4); 58 (76%) male) consisted of patients with mostly chronic PT (median symptom duration 2 years', 'patients with patellar tendinopathy (PT', '38 patients']","['progressive tendon-loading exercise therapy', 'PTLE', 'progressive tendon-loading exercises (PTLE) with eccentric exercise therapy (EET', 'PTLE or EET']","['exercise adherence', 'validated Victorian Institute of Sports Assessment for patellar tendons (VISA-P) questionnaire measuring pain, function and ability to play sports', 'subjective patient satisfaction', 'higher return to sports rate', 'return to sports rate, subjective patient satisfaction and exercise adherence', 'VISA-P score', 'clinical outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0577487', 'cui_str': 'Ability to play'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.157695,"No significant between-group difference was found for subjective patient satisfaction (81% vs 83%, p=0.54) and exercise adherence between the PTLE group and EET group after 24 weeks (40% vs 49%, p=0.33).
","[{'ForeName': 'Stephan J', 'Initials': 'SJ', 'LastName': 'Breda', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands s.breda@erasmusmc.nl.'}, {'ForeName': 'Edwin H G', 'Initials': 'EHG', 'LastName': 'Oei', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Zwerver', 'Affiliation': 'Centre for Human Movement Sciences, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Visser', 'Affiliation': 'Department of Physical Therapy, Sportgeneeskunde Rotterdam, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Waarsing', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Gabriel P', 'Initials': 'GP', 'LastName': 'Krestin', 'Affiliation': 'Department of Radiology & Nuclear Medicine, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'de Vos', 'Affiliation': 'Department of Orthopaedics and Sports Medicine, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",British journal of sports medicine,['10.1136/bjsports-2020-103403']
2644,33219117,Low-cost exercise interventions improve long-term cardiometabolic health independently of a family history of type 2 diabetes: a randomized parallel group trial.,"INTRODUCTION


To investigate the effect of an exercise prescription and a 1-year supervised exercise intervention, and the modifying effect of the family history of type 2 diabetes (FH), on long-term cardiometabolic health.
RESEARCH DESIGN AND METHODS


For this prospective randomized trial, we recruited non-diabetic participants with poor fitness (n=1072, 30-70 years). Participants were randomly assigned with stratification for FH either in the exercise prescription group (PG, n=144) or the supervised exercise group (EG, n=146) group and compared with a matched control group from the same population study (CON, n=782). The PG and EG received exercise prescriptions. In addition, the EG attended supervised exercise sessions two times a week for 60 min for 12 months. Cardiometabolic risk factors were measured at baseline, 1 year, 5 years, and 6 years. The CON group received no intervention and was measured at baseline and 6 years.
RESULTS


The EG reduced their body weight, waist circumference, diastolic blood pressure, and low-density lipoprotein-cholesterol (LDL-C) but not physical fitness (p=0.074) or insulin or glucose regulation (p>0.1) compared with the PG at 1 year and 5 years (p≤0.011). The observed differences were attenuated at 6 years; however, participants in the both intervention groups significantly improved their blood pressure, high-density lipoprotein-cholesterol, and insulin sensitivity compared with the population controls (p≤0.003). FH modified LDL-C and waist circumference responses to exercise at 1 year and 5 years.
CONCLUSIONS


Low-cost physical activity programs have long-term beneficial effects on cardiometabolic health regardless of the FH of diabetes. Given the feasibility and low cost of these programs, they should be advocated to promote cardiometabolic health.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier NCT02131701.",2020,"The observed differences were attenuated at 6 years; however, participants in the both intervention groups significantly improved their blood pressure, high-density lipoprotein-cholesterol, and insulin sensitivity compared with the population controls (p≤0.003).","['recruited non-diabetic participants with poor fitness (n=1072, 30-70 years', 'family history of type 2 diabetes']","['exercise prescription and a 1-year supervised exercise intervention', 'CON', 'Low-cost exercise interventions', 'FH either in the exercise prescription group (PG, n=144) or the supervised exercise group (EG, n=146) group and compared with a matched control group']","['FH modified LDL-C and waist circumference responses', 'body weight, waist circumference, diastolic blood pressure, and low-density lipoprotein-cholesterol (LDL-C) but not physical fitness (p=0.074) or insulin or glucose regulation', 'Cardiometabolic risk factors', 'blood pressure, high-density lipoprotein-cholesterol, and insulin sensitivity']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",,0.0537575,"The observed differences were attenuated at 6 years; however, participants in the both intervention groups significantly improved their blood pressure, high-density lipoprotein-cholesterol, and insulin sensitivity compared with the population controls (p≤0.003).","[{'ForeName': 'Niko S', 'Initials': 'NS', 'LastName': 'Wasenius', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Helsinki, Finland niko.wasenius@helsinki.fi.'}, {'ForeName': 'Bo A', 'Initials': 'BA', 'LastName': 'Isomaa', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Östman', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Söderström', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Forsén', 'Affiliation': 'Närpes Health Care Center, Närpes, Finland.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Lahti', 'Affiliation': 'Vaasa Central Hospital, Vaasa, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Hakaste', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}, {'ForeName': 'Johan G', 'Initials': 'JG', 'LastName': 'Eriksson', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Groop', 'Affiliation': 'Center of Excellence in Complex Disease Genetics, Institute of Molecular Medicine Finland, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Hansson', 'Affiliation': 'Center of Excellence in Complex Disease Genetics, Institute of Molecular Medicine Finland, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tiinamaija', 'Initials': 'T', 'LastName': 'Tuomi', 'Affiliation': 'Folkhälsan Research Center, Helsinki, Finland.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001377']
2645,33219133,COVID-19 aerosol box as protection from droplet and aerosol contaminations in healthcare workers performing airway intubation: a randomised cross-over simulation study.,"BACKGROUND


Concerns over high transmission risk of SARS-CoV-2 have led to innovation and usage of an aerosol box to protect healthcare workers during airway intubation in patients with COVID-19. Its efficacy as a barrier protection in addition to the use of a standard personal protective equipment (PPE) is not fully known. We performed a simulated study to investigate the relationship between aerosol box usage during intubation and contaminations on healthcare workers pre-doffing and post-doffing of PPE.
METHODS


This was a randomised cross-over study conducted between 9 April to 5 May 2020 in the ED of University Malaya Medical Centre. Postgraduate Emergency Medicine trainees performed video laryngoscope-assisted intubation on an airway manikin with and without an aerosol box in a random order. Contamination was simulated by nebulised Glo Germ. Primary outcome was number of contaminated front and back body regions pre-doffing and post-doffing of PPE of the intubator and assistant. Secondary outcomes were intubation time, Cormack-Lehane score, number of intubation attempts and participants' feedback.
RESULTS


Thirty-six trainees completed the study interventions. The number of contaminated front and back body regions pre-doffing of PPE was significantly higher without the aerosol box (all p values<0.001). However, there was no significant difference in the number of contaminations post-doffing of PPE between using and not using the aerosol box, with a median contamination of zero. Intubation time was longer with the aerosol box (42.5 s vs 35.5 s, p<0.001). Cormack-Lehane scores were similar with and without the aerosol box. First-pass intubation success rate was 94.4% and 100% with and without the aerosol box, respectively. More participants reported reduced mobility and visibility when intubating with the aerosol box.
CONCLUSIONS


An aerosol box may significantly reduce exposure to contaminations but with increased intubation time and reduced operator's mobility and visibility. Furthermore, the difference in degree of contamination between using and not using an aerosol box could be offset by proper doffing of PPE.",2020,"Intubation time was longer with the aerosol box (42.5 s vs 35.5 s, p<0.001).","['9 April to 5 May 2020 in the ED of University Malaya Medical Centre', 'Thirty-six trainees completed the study interventions', 'Postgraduate Emergency Medicine trainees', 'healthcare workers performing airway intubation', 'patients with COVID-19']","['standard personal protective equipment (PPE', 'video laryngoscope-assisted intubation', 'COVID-19 aerosol box']","['Cormack-Lehane scores', 'number of contaminated front and back body regions pre-doffing of PPE', 'intubation success rate', 'number of contaminated front and back body regions pre-doffing and post-doffing of PPE of the intubator and assistant', 'number of contaminations post-doffing of PPE', ""intubation time, Cormack-Lehane score, number of intubation attempts and participants' feedback"", 'Intubation time', ""intubation time and reduced operator's mobility and visibility"", 'mobility and visibility']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0005898', 'cui_str': 'Body region structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.110203,"Intubation time was longer with the aerosol box (42.5 s vs 35.5 s, p<0.001).","[{'ForeName': 'Muhaimin', 'Initials': 'M', 'LastName': 'Noor Azhar', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Bustam', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia aidabustam@um.edu.my.'}, {'ForeName': 'Khadijah', 'Initials': 'K', 'LastName': 'Poh', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ahmad Zulkarnain', 'Initials': 'AZ', 'LastName': 'Ahmad Zahedi', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Zahir Amin', 'Initials': 'MZA', 'LastName': 'Mohd Nazri', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohammad Aizuddin', 'Initials': 'MA', 'LastName': 'Azizah Ariffin', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Hafyzuddin', 'Initials': 'MH', 'LastName': 'Md Yusuf', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aliyah', 'Initials': 'A', 'LastName': 'Zambri', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Johnathan Y O', 'Initials': 'JYO', 'LastName': 'Chong', 'Affiliation': 'Department of Emergency Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Anhar', 'Initials': 'A', 'LastName': 'Kamarudin', 'Affiliation': 'Academic Unit of Emergency Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Bin Ting', 'Initials': 'BT', 'LastName': 'Ang', 'Affiliation': 'Department of Emergency Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Affan', 'Initials': 'A', 'LastName': 'Iskandar', 'Affiliation': 'Department of Emergency Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Keng Sheng', 'Initials': 'KS', 'LastName': 'Chew', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of Malaysia Sarawak, Kota Samarahan, Malaysia.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-210514']
2646,33219392,Plasma lipidomic profiles after a low and high glycemic load dietary pattern in a randomized controlled crossover feeding study.,"BACKGROUND


Dietary patterns low in glycemic load are associated with reduced risk of cardiometabolic diseases. Improvements in serum lipid concentrations may play a role in these observed associations.
OBJECTIVE


We investigated how dietary patterns differing in glycemic load affect clinical lipid panel measures and plasma lipidomics profiles.
METHODS


In a crossover, controlled feeding study, 80 healthy participants (n = 40 men, n = 40 women), 18-45 y were randomized to receive low-glycemic load (LGL) or high glycemic load (HGL) diets for 28 days each with at least a 28-day washout period between controlled diets. Fasting plasma samples were collected at baseline and end of each diet period. Lipids on a clinical panel including total-, VLDL-, LDL-, and HDL-cholesterol and triglycerides were measured using an auto-analyzer. Lipidomics analysis using mass-spectrometry provided the concentrations of 863 species. Linear mixed models and lipid ontology enrichment analysis were implemented.
RESULTS


Lipids from the clinical panel were not significantly different between diets. Univariate analysis showed that 67 species on the lipidomics panel, predominantly in the triacylglycerol class, were higher after the LGL diet compared to the HGL (FDR < 0.05). Three species with FA 17:0 were lower after LGL diet with enrichment analysis (FDR < 0.05).
CONCLUSION


In the context of controlled eucaloric diets with similar macronutrient distribution, these results suggest that there are relative shifts in lipid species, but the overall pool does not change. Further studies are needed to better understand in which compartment the different lipid species are transported in blood, and how these shifts are related to health outcomes. This trial was registered at clinicaltrials.gov as NCT00622661.",2020,"Three species with FA 17:0 were lower after LGL diet with enrichment analysis (FDR < 0.05).
","['80 healthy participants (n\u2009=\u200940 men, n\u2009=\u200940 women), 18-45 y']",['low-glycemic load (LGL) or high glycemic load (HGL) diets'],"['Fasting plasma samples', 'Plasma lipidomic profiles', 'serum lipid concentrations', 'total-, VLDL-, LDL-, and HDL-cholesterol and triglycerides']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4042927', 'cui_str': 'Glycemic Load'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",80.0,0.0682855,"Three species with FA 17:0 were lower after LGL diet with enrichment analysis (FDR < 0.05).
","[{'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Dibay Moghadam', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Navarro', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shojaie', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Randolph', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Northwest Metabolomics Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Le', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Northwest Metabolomics Research Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Hullar', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Kratz', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA.'}, {'ForeName': 'Johanna W', 'Initials': 'JW', 'LastName': 'Lampe', 'Affiliation': 'Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, USA. jlampe@fredhutch.org.'}]",Metabolomics : Official journal of the Metabolomic Society,['10.1007/s11306-020-01746-3']
2647,33219407,Adverse childhood experiences (ACEs) and medically traumatic events (TEs) in adolescents and young adults (AYAs) with cancer: a report from the Promoting Resilience in Stress Management (PRISM) randomized controlled trial.,"OBJECTIVE


In adolescents and young adults (AYAs) with cancer, we examined (1) the distribution and type of traumatic events (TEs) experienced prior to baseline assessment and (2) how a resilience intervention, Promoting Resilience in Stress Management (PRISM), impacted changes in patient-reported outcomes (PROs) for AYAs with and without TEs.
METHODS


AYAs (12-25 years) within 1-10 weeks of diagnosis of new malignancy or ever diagnosed with advanced cancer were enrolled and randomly assigned to usual care (UC) with or without PRISM. To assess TEs, we screened medical records for traditionally defined adverse childhood experiences (ACEs) and medical traumatic events. Age-validated PROs assessed resilience, benefit-finding, hope, generic health-related quality of life (QoL), cancer-specific QoL, depression, and anxiety at enrollment and 6 months later. We calculated effect sizes (Cohen's d) for PRISM vs. UC effect on PRO score change at 6 months for 1+ TEs and 0 TE groups.
RESULTS


Ninety-two AYAs enrolled and completed baseline surveys (44-UC, 48-PRISM; N = 74 at 6 months, 38-UC, 36-PRISM); 60% experienced 1+ TEs. PROs at baseline were similar across groups. PRISM's effect on score change was greater (Cohen's d ≥ 0.5) for the 1+ TE group on domains of benefit-finding and hope; and similar (d < 0.5) on domains of resilience, depression, anxiety, and both generic and cancer-specific QoL.
CONCLUSIONS


In AYAs with cancer, TEs occurred at similar rates as the general population. PRISM may be particularly helpful for improving benefit-finding and hope for those who have experienced TEs.",2020,"PRISM's effect on score change was greater (Cohen's d ≥ 0.5) for the 1+ TE group on domains of benefit-finding and hope; and similar (d < 0.5) on domains of resilience, depression, anxiety, and both generic and cancer-specific QoL.
CONCLUSIONS


","['Ninety-two AYAs enrolled and completed baseline surveys (44-UC, 48-PRISM; N = 74 at 6 months, 38-UC, 36-PRISM); 60% experienced 1+ TEs', 'adolescents and young adults (AYAs) with cancer', 'AYAs (12-25 years) within 1-10 weeks of diagnosis of new malignancy or ever diagnosed with advanced cancer']",['usual care (UC) with or without PRISM'],"['Adverse childhood experiences (ACEs) and medically traumatic events (TEs', 'Age-validated PROs assessed resilience, benefit-finding, hope, generic health-related quality of life (QoL), cancer-specific QoL, depression, and anxiety', 'PRO score change', 'domains of resilience, depression, anxiety, and both generic and cancer-specific QoL', 'score change']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",92.0,0.154026,"PRISM's effect on score change was greater (Cohen's d ≥ 0.5) for the 1+ TE group on domains of benefit-finding and hope; and similar (d < 0.5) on domains of resilience, depression, anxiety, and both generic and cancer-specific QoL.
CONCLUSIONS


","[{'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Scott', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': ""O'Daffer"", 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Bradford', 'Affiliation': ""Children's Core for Biomedical Statistics, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Fladeboe', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lau', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Steineck', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Joyce P', 'Initials': 'JP', 'LastName': 'Yi-Frazier', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Rosenberg', 'Affiliation': ""Palliative Care & Resilience Lab, Seattle Children's Research Institute, Seattle, WA, USA. Abby.Rosenberg@seattlechildrens.org.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05888-x']
2648,33219421,Repetitive transcranial magnetic stimulation for post-stroke depression: a randomised trial with neurophysiological insight.,"OBJECTIVE


Despite high incidence of depression after stroke, few trials have investigated the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS). Here, we aimed to evaluate clinical benefit of delivering a higher dose of rTMS compared to previous stroke trials. Secondary aims were to document adverse effects and investigate the role of functional connectivity as a potential mechanism of clinical response to rTMS treatment.
METHODS


Eleven chronic stroke survivors were recruited to a double-blind, Sham-controlled, randomised trial to investigate 10 sessions of high-frequency rTMS for depression. Clinical assessments were obtained at baseline, after treatment and a 1-month follow-up. Adverse events were documented at completion of the treatment. Resting electroencephalography recordings were performed at baseline and after treatment to estimate functional connectivity.
RESULTS


There were no differences in baseline characteristics between groups (all p ≥ 0.42). Beck Depression Inventory scores decreased for the Active rTMS group from baseline to 1-month follow-up (p = 0.04), but did not change for the Sham group at post-treatment or follow-up (p ≥ 0.17). Stronger theta frequency functional connectivity between the left frontal cortex and right parietal cortex was associated with lower baseline depression (r = - 0.71, p = 0.05). This network strength increased following Active rTMS, with change in connectivity associated with improvement in BDI scores (r = 0.98, p = 0.001). Adverse events were transient and minor and were not statistically different between groups (p ≥ 0.21).
CONCLUSIONS


Active rTMS significantly improved depression and was well tolerated. The mechanistic role of theta frequency functional connectivity appears worthy of further investigation. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001303134) on September 23, 2019.",2020,"Beck Depression Inventory scores decreased for the Active rTMS group from baseline to 1-month follow-up (p = 0.04), but did not change for the Sham group at post-treatment or follow-up (p ≥ 0.17).","['post-stroke depression', 'Eleven chronic stroke survivors']","['rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'Repetitive transcranial magnetic stimulation']","['Beck Depression Inventory scores', 'BDI scores', 'Adverse events', 'depression', 'tolerated']","[{'cui': 'C2938940', 'cui_str': 'Post stroke depression'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.570398,"Beck Depression Inventory scores decreased for the Active rTMS group from baseline to 1-month follow-up (p = 0.04), but did not change for the Sham group at post-treatment or follow-up (p ≥ 0.17).","[{'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Hordacre', 'Affiliation': 'Innovation, IMPlementation and Clinical Translation (IIMPACT) in Health, Allied Health and Human Performance, University of South Australia, City East Campus, GPO Box 2471, Adelaide, South Australia, 5001, Australia. brenton.hordacre@unisa.edu.au.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Comacchio', 'Affiliation': 'Innovation, IMPlementation and Clinical Translation (IIMPACT) in Health, Allied Health and Human Performance, University of South Australia, City East Campus, GPO Box 2471, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Williams', 'Affiliation': 'Innovation, IMPlementation and Clinical Translation (IIMPACT) in Health, Allied Health and Human Performance, University of South Australia, City East Campus, GPO Box 2471, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hillier', 'Affiliation': 'Innovation, IMPlementation and Clinical Translation (IIMPACT) in Health, Allied Health and Human Performance, University of South Australia, City East Campus, GPO Box 2471, Adelaide, South Australia, 5001, Australia.'}]",Journal of neurology,['10.1007/s00415-020-10315-6']
2649,33219473,Clinical study on empirical and diagnostic-driven (pre-emptive) therapy of voriconazole in severe aplastic anaemia patients with invasive fungal disease after intensive immunosuppressive therapy.,"The aim of this study is to compare the curative effect of empirical with diagnostic-driven (pre-emptive) therapy of voriconazole in severe aplastic anaemia patients (SAAs) with invasive fungal disease (IFD) after intensive immunosuppressive therapy (IST). Patients undergoing voriconazole antifungal therapy were randomized to empirical therapy group and diagnostic-driven therapy group. Empirical therapy group accounted for 48.5% of all cases, and diagnostic-driven therapy group accounted for 51.5%. The morbidity of IFD (probable and proven cases) was slightly increased in diagnostic-driven therapy group compared with empirical therapy group (P > 0.05). The total effective rate was 62.1%. The effective rate in empirical therapy group was 78.1%, which was significantly increased compared with diagnostic-driven therapy group (47.1%) (P < 0.05). This value was especially significant in possible IFD cases (P < 0.05). The efficacy of possible IFD cases in empirical therapy group was the best (84%) followed by the probable and proven cases in empirical therapy group (57.1%). In diagnostic-driven therapy group, the efficacy of possible IFD cases was 50%, and the efficacy of probable and proven cases was only 37.5%. The difference was statistically significant (P < 0.05). Absolute neutrophil count (ANC) is the key anti-infection factor. The efficacy of patients whose ANC ˂ 0.1 × 10 9 /L was 39.28%, which was significantly reduced compared with that of patients whose ANC ≥ 0.1 × 10 9 /L (78.95%) (P < 0.05). This finding was especially obvious in diagnostic-driven therapy group. As empirical therapy is superior to diagnostic-driven therapy, we recommend that empirical therapy should be started for high-risk patients, and efforts should be made to definitively diagnose the disease.",2020,The efficacy of possible IFD cases in empirical therapy group was the best (84%) followed by the probable and proven cases in empirical therapy group (57.1%).,"['severe aplastic anaemia patients (SAAs) with invasive fungal disease (IFD) after intensive immunosuppressive therapy (IST', 'Patients undergoing', 'severe aplastic anaemia patients with invasive fungal disease after intensive immunosuppressive therapy']","['diagnostic-driven (pre-emptive) therapy of voriconazole', 'empirical therapy group and diagnostic-driven therapy group', 'voriconazole antifungal therapy']","['Absolute neutrophil count (ANC', 'total effective rate', 'effective rate', 'morbidity of IFD']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002874', 'cui_str': 'Aplastic anemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C1299597', 'cui_str': 'Empirical therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}]","[{'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1262313', 'cui_str': 'Invasive fungal infection'}]",,0.019606,The efficacy of possible IFD cases in empirical therapy group was the best (84%) followed by the probable and proven cases in empirical therapy group (57.1%).,"[{'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China.'}, {'ForeName': 'Huaquan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China.'}, {'ForeName': 'Zonghong', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Department of Hematology, General Hospital of Tianjin Medical University, 154 Anshandao, Heping District, Tianjin, 300052, China. shaozonghong@sina.com.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-04054-9']
2650,33216167,Nicotinic receptor modulation of the default mode network.,"RATIONALE


Previous neuroimaging studies of cognition involving nicotinic acetylcholine receptor (nAChR) agonist administration have repeatedly found enhanced task-induced deactivation of regions of the default mode network (DMN), a group of brain systems that is more active at rest and mediates task-independent thought processes. This effect may be related to pro-cognitive nAChR agonist effects OBJECTIVES: The present study sought to test whether nAChR modulation of the DMN is bi-directional, i.e., whether a nAChR antagonist would reduce task-induced deactivation.
METHODS


Eighteen healthy non-smokers underwent functional magnetic resonance imaging while performing a letter N-back task. Scans were performed after nicotine administration (7 mg/24 h, transdermally), after administration of the nAChR antagonist mecamylamine (7.5 mg, p.o.), and after double placebo, in counterbalanced sequence. Blood-oxygen-level-dependent (BOLD) signal was analyzed within ventromedial prefrontal cortex (vmPFC) and posterior cingulate cortex (PCC) regions of interest-central hubs of the DMN in which consistent nAChR agonist-induced changes had previously been identified.
RESULTS


Nicotine enhanced hit rate in both the 0-back and 2-back condition, while mecamylamine slowed reaction time in the 2-back condition. Mecamylamine reduced task-induced deactivation of vmPFC and PCC. Nicotine had no significant effects on the BOLD signal.
CONCLUSIONS


The finding that nAChR tone reduction by mecamylamine weakened task-induced DMN deactivation indicates that a constant tone of nAChR activation helps regulate DMN activity in healthy individuals. This suggests that low nAChR tone may play a causal role in DMN dysregulation seen in conditions such as mild cognitive impairment or Alzheimer's disease.",2020,Mecamylamine reduced task-induced deactivation of vmPFC and PCC.,"['healthy individuals', 'Eighteen healthy non-smokers']","['mecamylamine', 'placebo', 'Nicotine', 'nicotinic acetylcholine receptor (nAChR) agonist administration', 'nAChR antagonist', 'functional magnetic resonance imaging while performing a letter N-back task', 'nAChR antagonist mecamylamine', 'Mecamylamine']","['Blood-oxygen-level-dependent (BOLD) signal', 'hit rate', 'reaction time', 'BOLD signal']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0025029', 'cui_str': 'Mecamylamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0034830', 'cui_str': 'Nicotinic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",18.0,0.0957418,Mecamylamine reduced task-induced deactivation of vmPFC and PCC.,"[{'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Hahn', 'Affiliation': 'University of Maryland School of Medicine, Maryland Psychiatric Research Center, P.O. Box 21247, Baltimore, MD, 21228, USA. bhahn@som.umaryland.edu.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Harvey', 'Affiliation': 'University of Maryland School of Medicine, Maryland Psychiatric Research Center, P.O. Box 21247, Baltimore, MD, 21228, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Concheiro-Guisan', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse Intramural Research Program, 251 Bayview Blvd, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse Intramural Research Program, 251 Bayview Blvd, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse Intramural Research Program, 251 Bayview Blvd, Suite 200, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elliot A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse Intramural Research Program, 251 Bayview Blvd, Suite 200, Baltimore, MD, 21224, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05711-9']
2651,33216196,Effects of three months of treatment with vitamin E and N-acetyl cysteine on the oxidative balance in patients with transfusion-dependent β-thalassemia.,"Oxidative stress is a major mechanism contributing to the progression of β-thalassemia. To assess the effect of vitamin E and N-acetyl cysteine (NAC) as antioxidant agents on total oxidative stress (TOS) status and total antioxidant capacity (TAC) in patients with transfusion-dependent β-thalassemia (TDT). In this open-label randomized controlled trial, from May to August 2019, 78 eligible patients with TDT over the age of 18 were enrolled. All patients were registered at the Thalassemia Clinic of Shiraz University of Medical Sciences in Southern Iran. Patients were randomly allocated to the NAC group (10 mg/kg/day, orally), vitamin E group (10 U/kg/day, orally), and control group. The duration of the study was 3 months. The mean age of the participants was 28.5 ± 5.1 (range: 18-41) years. At the end of the study, TOS significantly decreased only in the vitamin E group (mean difference (MD), 95% confidence interval (CI): 0.27 (0.03-0.50), P = 0.026). TAC significantly decreased in both supplemented groups at the 3rd month of treatment (NAC group: MD (95% CI): 0.11 (0.04-0.18), P = 0.002 and vitamin E group: 0.09 (0.01-0.16), P = 0.022 respectively). Hemoglobin did not significantly change at the end of the study in each group (P > 0.05). Mild transient adverse events occurred in 4 patients of the NAC group and 5 patients of the vitamin E group with no need to discontinue the treatment. Vitamin E can be a safe and effective supplement in improving oxidative stress in patients with TDT. Moreover, it seems that a longer duration of using antioxidant supplements needs to make clinical hematologic improvement in TDT patients.",2020,Hemoglobin did not significantly change at the end of the study in each group (P > 0.05).,"['patients with transfusion-dependent β-thalassemia', 'All patients were registered at the Thalassemia Clinic of Shiraz University of Medical Sciences in Southern Iran', 'The mean age of the participants was 28.5 ± 5.1 (range: 18-41) years', 'patients with TDT', '78 eligible patients with TDT over the age of 18 were enrolled', 'patients with transfusion-dependent β-thalassemia (TDT', 'TDT patients']","['vitamin E and N-acetyl cysteine (NAC', 'Vitamin E', 'NAC', 'vitamin E and N-acetyl cysteine', 'vitamin E']","['total oxidative stress (TOS) status and total antioxidant capacity (TAC', 'TOS', 'Hemoglobin', 'oxidative stress', 'oxidative balance', 'Mild transient adverse events', 'TAC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.0715614,Hemoglobin did not significantly change at the end of the study in each group (P > 0.05).,"[{'ForeName': 'Sezaneh', 'Initials': 'S', 'LastName': 'Haghpanah', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Cohan', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Bordbar', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Asghar', 'Initials': 'A', 'LastName': 'Bazrafshan', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Zareifar', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Safaei', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Aramesh', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Moghadam', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Saeid Amiri Zadeh', 'Initials': 'SAZ', 'LastName': 'Fard', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Zekavat', 'Affiliation': 'Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. ozekavat@gmail.com.'}]",Annals of hematology,['10.1007/s00277-020-04346-2']
2652,33216238,Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study.,"PURPOSE


Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol.
METHODS


This pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10 mg twice daily and oral oxycodone immediate-release 5 mg up to four times daily on demand (Oxy group) to control pain during 48 h postoperatively. The primary endpoint was pain measured using a numeric rating scale at 24 h postoperatively. Time to first mobilization, side effects and patient satisfaction were also recorded.
RESULTS


Median pain score at 24 h at rest was 3 [2-4] for Oxy group vs 2 [1.75-3] for SSTS group (p = 0.272) whereas median pain score on movement was 4 [3-6] vs 3 [2-5] respectively (p = 0.059). No difference in time to first mobilization was found between the two groups. The method of pain control was judged good/excellent for 83.9% of patients in the SSTS group compared with 52.9% in the Oxy group (p = 0.007). The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181).
CONCLUSIONS


In complement to ERAS multimodal analgesia, sublingual sufentanil 15 mcg tablet system did not show clinically significant pain improvement compared to oral oxycodone after total knee arthroplasty.
TRIAL REGISTRATION


Clinical Trials: NCT04448457 ; retrospectively registered on June 24, 2020. https://clinicaltrials.gov/ct2/show/NCT04448457?cond=sublingual+sufentanil&cntry=BE&draw=2&rank=3.",2020,"The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181).
","['postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol', 'total knee arthroplasty', '72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway']","['Sufentanil sublingual tablet system versus oral oxycodone', 'SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10\u2009mg twice daily and oral oxycodone immediate-release 5\u2009mg up to four times daily on demand (Oxy group) to control pain', 'oxycodone', 'sublingual sufentanil', 'sufentanil sublingual tablet system (SSTS']","['pain measured using a numeric rating scale', 'time to first mobilization', 'pain improvement', 'Time to first mobilization, side effects and patient satisfaction', 'pain control', 'Median pain score', 'incidence of nausea', 'median pain score']","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C4735306', 'cui_str': 'Sufentanil Sublingual Tablet'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",72.0,0.155885,"The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p = 0.181).
","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Noel', 'Affiliation': 'Anesthesiology, CHU Tivoli Hospital, Avenue Max Buset, 34, 7100, La Louvière, Belgium. enoel@chu-tivoli.be.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Miglionico', 'Affiliation': 'Anesthesiology, CHU Tivoli Hospital, Avenue Max Buset, 34, 7100, La Louvière, Belgium.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Leclercq', 'Affiliation': 'Anesthesiology, CHU Tivoli Hospital, Avenue Max Buset, 34, 7100, La Louvière, Belgium.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Jennart', 'Affiliation': 'Orthopedic surgery, CHU Tivoli Hospital, La Louvière, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Fils', 'Affiliation': 'ARS Statistica, statistics, Nivelles, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Van Rompaey', 'Affiliation': 'Anesthesiology, CHU Tivoli Hospital, Avenue Max Buset, 34, 7100, La Louvière, Belgium.'}]",Journal of experimental orthopaedics,['10.1186/s40634-020-00306-x']
2653,33216275,Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome.,"PURPOSE


The efficacy of levoketoconazole in treating hypercortisolism was demonstrated in an open-label phase 3 study (SONICS) of adults with endogenous Cushing's syndrome (CS) and baseline mean urinary free cortisol (mUFC) ≥  1.5× ULN. Clinical signs and symptoms and patient-reported outcomes from the SONICS trial were evaluated in the current manuscript.
METHODS


Patients titrated to an individualized therapeutic dose entered a 6-month maintenance phase. Secondary endpoints included investigator-graded clinical signs and symptoms of CS during the maintenance phase, and patient-reported quality of life (CushingQoL questionnaire) and depression symptoms (Beck Depression Inventory II [BDI-II]).
RESULTS


Of 94 enrolled patients, 77 entered the maintenance phase following individualized dose titration. Significant mean improvements from baseline were noted at end of maintenance (Month 6) for acne, hirsutism (females only), and peripheral edema. These improvements were observed as early as Day 1 of maintenance for hirsutism (mean baseline score, 7.8; ∆ - 1.9; P < 0.0001), end of Month 1 for acne (mean baseline score, 2.8; ∆ - 1.2; P = 0.0481), and Month 4 for peripheral edema (mean baseline score, 1.0; ∆ - 0.5; P = 0.0052). Significant mean improvements from baseline were observed by Month 3 of maintenance for CushingQoL (mean baseline score, 44.3; ∆ + 6.9; P = 0.0018) and at Month 6 for BDI-II (mean baseline score, 17.1; ∆ - 4.3; P = 0.0043) scores. No significant mean improvement was identified in a composite score of 7 other clinical signs and symptoms.
CONCLUSIONS


Treatment with levoketoconazole was associated with sustained, meaningful improvements in QoL, depression, and certain clinical signs and symptoms characteristic of CS. ClinialTrials.gov identifier: NCT01838551.",2020,"Significant mean improvements from baseline were noted at end of maintenance (Month 6) for acne, hirsutism (females only), and peripheral edema.","[""patients with Cushing's syndrome"", '94 enrolled patients', ""adults with endogenous Cushing's syndrome (CS) and baseline mean urinary free cortisol (mUFC)\u2009≥\u2009 1.5× ULN""]","['Levoketoconazole', 'levoketoconazole']","['hirsutism', 'composite score of 7 other clinical signs and symptoms', 'investigator-graded clinical signs and symptoms of CS during the maintenance phase, and patient-reported quality of life (CushingQoL questionnaire) and depression symptoms (Beck Depression Inventory II [BDI-II', 'QoL, depression, and certain clinical signs and symptoms characteristic of CS', 'peripheral edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0010481', 'cui_str': ""Cushing's syndrome""}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}]",[],"[{'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}]",94.0,0.0317215,"Significant mean improvements from baseline were noted at end of maintenance (Month 6) for acne, hirsutism (females only), and peripheral edema.","[{'ForeName': 'Eliza B', 'Initials': 'EB', 'LastName': 'Geer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. geere@mskcc.org.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvatori', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Atanaska', 'Initials': 'A', 'LastName': 'Elenkova', 'Affiliation': 'Medical University Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Università Federico II di Napoli, Naples, Italy.'}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Witek', 'Affiliation': 'Department of Internal Diseases, Endocrinology and Diabetes, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Feelders', 'Affiliation': 'Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bex', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Stina W', 'Initials': 'SW', 'LastName': 'Borresen', 'Affiliation': 'Department of Medical Endocrinology and Metabolism, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Puglisi', 'Affiliation': 'Department of Clinical and Biological Sciences, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Italy.'}, {'ForeName': 'Beverly M K', 'Initials': 'BMK', 'LastName': 'Biller', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Cohen', 'Affiliation': 'Strongbridge Biopharma, Trevose, PA, USA.'}, {'ForeName': 'F Pecori', 'Initials': 'FP', 'LastName': 'Giraldi', 'Affiliation': 'Department of Clinical Sciences & Community Health, University of Milan, Milan, Italy.'}]",Pituitary,['10.1007/s11102-020-01103-6']
2654,33216357,"Mobile messenger-initiated reminders improve longitudinal adherence in a community-based, opportunistic colorectal cancer screening program: A single-blind, crossover randomized controlled study.","BACKGROUND


The fecal immunochemical test (FIT) is a cost-effective colorectal cancer (CRC) screening tool. However, longitudinal adherence, a factor that is critical to the success to any FIT-based screening program, often is poor. The authors hypothesized that reminders sent via mobile messengers, such as WhatsApp, improve such adherence.
METHODS


In the current single-blind, randomized study, subjects from an opportunistic FIT screening program who had a negative FIT result the year prior were randomly allocated (1:1) to receive either a 1-off reminder via the WhatsApp messenger (WR) 1 month prior to the due appointments or no reminder (NR). All subjects were blinded to study participation and group allocation. At 24 months after randomization, a crossover of intervention was performed among those individuals who remained in the FIT program. The primary outcome was FIT adherence, defined as the pick-up and on-time return of the FIT. The secondary outcome was FIT adherence after the crossover.
RESULTS


A total of 500 subjects were randomized to receive WR (250 subjects) or NR (250 subjects). Three individuals were excluded from analysis (1 died and 2 underwent colonoscopy). Both the FIT pick-up rate (80.3% vs 59.3%; P < .001) and return rate (79.9% vs 57.3%; P < .001) were significantly higher in the WR group compared with the NR group. After crossover of intervention (452 subjects), the WR group again was found to have a higher FIT pick-up rate (79.1% vs 52.9%; P < .001) and return rate (78.2% vs 52.4%; P < .001).
CONCLUSIONS


Text reminders sent via mobile messenger appear to improve the longitudinal adherence to FIT-based opportunistic CRC screening programs. The routine use of this technology in CRC screening should be considered.",2020,Both the FIT pick-up rate (80.3% vs 59.3%; P < .001) and return rate (79.9% vs 57.3%; P < .001) were significantly higher in the WR group compared with the NR group.,"['subjects from an opportunistic FIT screening program who had a negative FIT result the year prior', '500 subjects were randomized to receive WR (250 subjects) or NR (250 subjects']","['Mobile messenger-initiated reminders', '1-off reminder via the WhatsApp messenger (WR) 1 month prior to the due appointments or no reminder (NR']","['longitudinal adherence', 'FIT adherence', 'return rate', 'FIT adherence, defined as the pick-up and on-time return of the FIT']","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0335218', 'cui_str': 'Messenger'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0335218', 'cui_str': 'Messenger'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",500.0,0.0421831,Both the FIT pick-up rate (80.3% vs 59.3%; P < .001) and return rate (79.9% vs 57.3%; P < .001) were significantly higher in the WR group compared with the NR group.,"[{'ForeName': 'Thomas Y T', 'Initials': 'TYT', 'LastName': 'Lam', 'Affiliation': 'Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Peter I', 'Initials': 'PI', 'LastName': 'Wu', 'Affiliation': 'Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Raymond S Y', 'Initials': 'RSY', 'LastName': 'Tang', 'Affiliation': 'Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Arthur K C', 'Initials': 'AKC', 'LastName': 'Luk', 'Affiliation': 'Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Simpson', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Joseph J Y', 'Initials': 'JJY', 'LastName': 'Sung', 'Affiliation': 'Institute of Digestive Disease, Chinese University of Hong Kong, Hong Kong, Hong Kong.'}]",Cancer,['10.1002/cncr.33336']
2655,33216360,"Bayesian methods to compare dose levels with placebo in a small n, sequential, multiple assignment, randomized trial.","Clinical trials studying treatments for rare diseases are challenging to design and conduct due to the limited number of patients eligible for the trial. One design used to address this challenge is the small n, sequential, multiple assignment, randomized trial (snSMART). We propose a new snSMART design that investigates the response rates of a drug tested at a low and high dose compared with placebo. Patients are randomized to an initial treatment (stage 1). In stage 2, patients are rerandomized, depending on their initial treatment and their response to that treatment in stage 1, to either the same or a different dose of treatment. Data from both stages are used to determine the efficacy of the active treatment. We present a Bayesian approach where information is borrowed between stage 1 and stage 2. We compare our approach to standard methods using only stage 1 data and a log-linear Poisson model that uses data from both stages where parameters are estimated using generalized estimating equations. We observe that the Bayesian method has smaller root-mean-square-error and 95% credible interval widths than standard methods in the tested scenarios. We conclude that it is advantageous to utilize data from both stages for a primary efficacy analysis and that the specific snSMART design shown here can be used in the registration of a drug for the treatment of rare diseases.",2020,We observe that the Bayesian method has smaller root-mean-square-error and 95% credible interval widths than standard methods in the tested scenarios.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.099717,We observe that the Bayesian method has smaller root-mean-square-error and 95% credible interval widths than standard methods in the tested scenarios.,"[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Hochstedler', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Roy N', 'Initials': 'RN', 'LastName': 'Tamura', 'Affiliation': 'Health Informatics Institute, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Kelley M', 'Initials': 'KM', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}]",Statistics in medicine,['10.1002/sim.8813']
2656,33216398,Evaluating an Intervention to Reduce Risky Driving Behaviors: Taking the Fear Out of Virtual Reality.,"Educational programs are the most common type of intervention to reduce risky driving behavior. Their success, however, depends on the content of the material used and the mode of delivery. In the present study, we examined the impact of fear versus positively framed road safety films and traditional technologies (2D) versus emerging technologies (VR) on young drivers' self-reported risky driving behaviors. One hundred and forty-six university students completed a similar set of questionnaires pre-intervention and post-intervention, two weeks later. In addition, they were randomly assigned to one of the four experimental conditions (VR vs. 2D; positive vs. negative). In the VR conditions, the film was presented using an HTC VIVE Virtual Reality headset. In the 2D conditions, the film was presented on a computer screen. Measures evaluating attitudes toward risky driving behavior were completed at both time frames, questions regarding the participants' emotional arousal were asked at pre-intervention as a manipulation check, and questions regarding willingness to take risks in potentially dangerous driving situations were asked at follow-up. The findings indicate that the positively framed films significantly decreased self-reported risky driving behaviors in both modalities, but especially when viewed in VR format. In contrast, the fear appeal film, when shown in VR, failed to reduce risky driving behaviors, and in fact, increased young drivers' self-reported risky driving behaviors. Theoretical frameworks regarding the strengths and weaknesses of fear appeals and positively framed appeals are discussed to aid future research to reduce risky driving. Practical implications on the future usage of VR are also considered.",2020,"The findings indicate that the positively framed films significantly decreased self-reported risky driving behaviors in both modalities, but especially when viewed in VR format.","[""young drivers' self-reported risky driving behaviors"", 'One hundred and forty-six university students']",['fear versus positively framed road safety films and traditional technologies (2D) versus emerging technologies (VR'],"['self-reported risky driving behaviors', 'risky driving behaviors', 'Risky Driving Behaviors', 'attitudes toward risky driving behavior']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.013722,"The findings indicate that the positively framed films significantly decreased self-reported risky driving behaviors in both modalities, but especially when viewed in VR format.","[{'ForeName': 'Clara Alida', 'Initials': 'CA', 'LastName': 'Cutello', 'Affiliation': 'School of Psychology, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Gummerum', 'Affiliation': 'School of Psychology, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Hanoch', 'Affiliation': 'Business School, University of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hellier', 'Affiliation': 'School of Psychology, University of Plymouth, Plymouth, PL4 8AA, UK.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13643']
2657,31808012,The effect of acetazolamide on the improvement of central apnea caused by abusing opioid drugs in the clinical trial.,"PURPOSE


Acetazolamide is utilized as a treatment which falls effective in treating some type of CSA. Hence, it might be effective as far as opium addicts who suffer from CSA are concerned.
MATERIALS AND METHOD


The current study was a double-blind, placebo-controlled, cross-over study ( clinicalTrials.gov ID: NCT02371473). The whole procedures were identical for both placebo and acetazolamide phases of clinical research. There were 14 CSA more than 5/h and more than 50% of apnea-hypopnea index (AHI). Out of these 14 patients, 10 volunteered to participate in the study. Fast Fourier transformation was used to separate heart rate variability (HRV) into its component VLF (very low frequency band), LF (low frequency band), and HF (high frequency band) rhythms that operate within different frequency ranges.
RESULT


There are significant results in terms of decreased mix apnea and central apnea together due to acetazolamide compared with placebo (P < 0.023). Time of SatO 2  < 90% is decreased as well (P < 0.1). There is also decrease of SDNN and NN50 after treatment with acetazolamide respectively (P < 0.001). Regarding fast Fourier transformation, there is increase of pHF and decrease of pLF after acetazolamide treatment (P < 0.001).
CONCLUSION


Acetazolamide seems to be effective in improving oxygenation and a decrease of mixed and central apnea events together. In HRV analysis section, LF power has decreased significantly, which may more likely improve prognosis of the patients.",2020,There is also decrease of SDNN and NN50 after treatment with acetazolamide respectively (P < 0.001).,"['14 patients, 10 volunteered to participate in the study']","['Acetazolamide', 'placebo and acetazolamide', 'acetazolamide', 'placebo']","['central apnea', 'apnea-hypopnea index (AHI', 'mix apnea and central apnea', 'pLF', 'SDNN and NN50']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}]",,0.039075,There is also decrease of SDNN and NN50 after treatment with acetazolamide respectively (P < 0.001).,"[{'ForeName': 'Parisa Adimi', 'Initials': 'PA', 'LastName': 'Naghan', 'Affiliation': 'Clinical Tuberculosis and Epidemiologic Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, PO Box: 19575-154, Tehran, 19569-44413, Iran. prs_adimi@yahoo.com.'}, {'ForeName': 'Khadijeh', 'Initials': 'K', 'LastName': 'Raeisi', 'Affiliation': 'School of Electrical Engineering, K.N. Toosi University of Technology, Tehran, Iran.'}, {'ForeName': 'Batoul', 'Initials': 'B', 'LastName': 'Khoundabi', 'Affiliation': 'Research Center for Health Management in Mass Gathering, Red Crescent Society of the Islamic Republic of Iran, Tehran, Iran.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Foroughi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Malekmohammad', 'Affiliation': 'Tracheal Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'School of Electrical Engineering, K.N. Toosi University of Technology, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Department of Internal Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Fanak', 'Initials': 'F', 'LastName': 'Fahimi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Science, Tehran, Iran.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-019-01968-3']
2658,31953524,Large-scale Analyses of Disease Biomarkers and Apremilast Pharmacodynamic Effects.,"Finding biomarkers that provide shared link between disease severity, drug-induced pharmacodynamic effects and response status in human trials can provide number of values for patient benefits: elucidating current therapeutic mechanism-of-action, and, back-translating to fast-track development of next-generation therapeutics. Both opportunities are predicated on proactive generation of human molecular profiles that capture longitudinal trajectories before and after pharmacological intervention. Here, we present the largest plasma proteomic biomarker dataset available to-date and the corresponding analyses from placebo-controlled Phase III clinical trials of the phosphodiesterase type 4 inhibitor apremilast in psoriasis (PSOR), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) from 526 subjects overall. Using approximately 150 plasma analytes tracked across three time points, we identified IL-17A and KLK-7 as biomarkers for disease severity and apremilast pharmacodynamic effect in psoriasis patients. Combined decline rate of KLK-7, PEDF, MDC and ANGPTL4 by Week 16 represented biomarkers for the responder subgroup, shedding insights into therapeutic mechanisms. In ankylosing spondylitis patients, IL-6 and LRG-1 were identified as biomarkers with concordance to disease severity. Apremilast-induced LRG-1 increase was consistent with the overall lack of efficacy in ankylosing spondylitis. Taken together, these findings expanded the mechanistic knowledge base of apremilast and provided translational foundations to accelerate future efforts including compound differentiation, combination, and repurposing.",2020,"In ankylosing spondylitis patients, IL-6",['psoriasis patients'],[],"['KLK-7, PEDF, MDC', 'IL-6']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0022478', 'cui_str': 'Kininogenase'}, {'cui': 'C0213321', 'cui_str': 'pigment epithelium-derived factor'}, {'cui': 'C0083360', 'cui_str': 'MDC protocol'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.025461,"In ankylosing spondylitis patients, IL-6","[{'ForeName': 'Irina V', 'Initials': 'IV', 'LastName': 'Medvedeva', 'Affiliation': 'Celgene Corporation, Informatics&Predictive Sciences, Cambridge, 02140, USA. imedvedeva@celgene.com.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Stokes', 'Affiliation': 'Celgene Corporation, Informatics&Predictive Sciences, Cambridge, 02140, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Eisinger', 'Affiliation': 'Myriad RBM Inc., Austin, 78759, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'LaBrie', 'Affiliation': 'Myriad RBM Inc., Austin, 78759, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ai', 'Affiliation': 'Celgene Corporation, Informatics&Predictive Sciences, Cambridge, 02140, USA.'}, {'ForeName': 'Matthew W B', 'Initials': 'MWB', 'LastName': 'Trotter', 'Affiliation': 'Celgene Corporation, Celgene Institute for Translational Research Europe (CITRE), Sevilla, 41092, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schafer', 'Affiliation': 'Celgene Corporation, Translational Development, Summit, 07901, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Celgene Corporation, Informatics&Predictive Sciences, Cambridge, 02140, USA.'}]",Scientific reports,['10.1038/s41598-020-57542-5']
2659,31963708,Docosahexaenoic Acid (DHA) Bioavailability in Humans after Oral Intake of DHA-Containing Triacylglycerol or the Structured Phospholipid AceDoPC ® .,"AceDoPC ®  is a structured glycerophospholipid that targets the brain with docosahexaenoic acid (DHA) and is neuroprotective in the experimental ischemic stroke. AceDoPC ®  is a stabilized form of the physiological 2-DHA-LysoPC with an acetyl group at the  sn1  position; preventing the migration of DHA from the  sn2  to  sn1  position. In this study we aimed to know the bioavailability of  13 C-labeled DHA after oral intake of a single dose of  13 C-AceDoPC ® , in comparison with  13 C-DHA in triglycerides (TAG), using gas chromatography/combustion/isotope ratio mass spectrometry (GC/C/IRMS) to assess the  13 C enrichment of DHA-containing lipids.  13 C-DHA enrichment in plasma phospholipids was significantly higher after intake of AceDoPC ®  compared with TAG-DHA, peaking after 24 h in both cases. In red cells,  13 C-DHA enrichment in choline phospholipids was comparable from both sources of DHA, with a maximum after 72 h, whereas the  13 C-DHA enrichment in ethanolamine phospholipids was higher from AceDoPC ®  compared to TAG-DHA, and continued to increase after 144 h. Overall, our study indicates that DHA from AceDoPC ®  is more efficient than from TAG-DHA for a sustained accumulation in red cell ethanolamine phospholipids, which has been associated with increased brain accretion.",2020,"13 C-DHA enrichment in plasma phospholipids was significantly higher after intake of AceDoPC ®  compared with TAG-DHA, peaking after 24 h in both cases.",['Humans after Oral Intake of DHA-Containing Triacylglycerol or the Structured Phospholipid AceDoPC ® '],"['Docosahexaenoic Acid (DHA', 'docosahexaenoic acid (DHA']",['plasma phospholipids'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C4077604', 'cui_str': '1-acetyl-2-docosahexaenoyl-glycerophosphocholine'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}]",,0.0361395,"13 C-DHA enrichment in plasma phospholipids was significantly higher after intake of AceDoPC ®  compared with TAG-DHA, peaking after 24 h in both cases.","[{'ForeName': 'Mayssa', 'Initials': 'M', 'LastName': 'Hachem', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Nacir', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Picq', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Belkouch', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bernoud-Hubac', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Windust', 'Affiliation': 'National Research Council Canada, Ottawa, ON K1A 0R6, Canada.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Meiller', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sauvinet', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Feugier', 'Affiliation': 'Hospices Civils de Lyon, Groupement Hospitalier Sud, 69310 Pierre-Bénite, France.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Hospices Civils de Lyon, Groupement Hospitalier Sud, 69310 Pierre-Bénite, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lagarde', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm UMR 1060, Inra UMR 1397, IMBL, INSA-Lyon, 69100 Villeurbanne, France.'}]",Nutrients,['10.3390/nu12010251']
2660,32104685,A New Risk Polymorphism rs10403848 of CARD8 Significantly Associated with Psoriasis Vulgaris in Northeastern China.,"Caspase recruitment domain family member 8 (CARD8) is an adaptor molecule that negatively regulates nuclear factor- κ B (NF- κ B) activation, interleukin (IL)-1 β  secretion, and apoptosis. These play important roles in the pathogenesis of psoriasis. Genetic variants of CARD8 have been associated with an increased risk of several inflammatory diseases and psoriasis in Europe. However, nothing is known about the association of the polymorphisms of CARD8 and psoriasis vulgaris (PsV) in the Han population of northeastern China. To investigate the potential association between them, we designed a case-control study to genotype four selected single nucleotide polymorphisms (SNPs) using the improved multiplex ligation reaction (iMLDR) method. Model-based single SNP frequentist-test and haplotype association studies were performed to assess the association between SNPs and PsV. The results showed that the intron SNP rs10403848 was significantly associated with PsV (additive model  p =0.0418,  p '=0.0411, and statistical power 0.1902; heterozygous model  p =0.0418,  p '=0.0164, and statistical power 0.9406). A potential risk locus of nonsynonymous SNP rs2043211 found in the European population did not show a significant association in our study. We found that the polymorphism rs10403848 in CARD8 is significantly associated with PsV risk in the Han population of northeastern China. CARD8 may be involved in PsV in this population, as in the European population, but a different genetic process should be considered for the heterogeneity of risk loci.",2020,A potential risk locus of nonsynonymous SNP rs2043211 found in the European population did not show a significant association in our study.,[],['CARD8'],"['nuclear factor- κ B (NF- κ B) activation, interleukin (IL)-1 β  secretion, and apoptosis']",[],"[{'cui': 'C4277612', 'cui_str': 'Caspase Activation and Recruitment Domains'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",,0.0137477,A potential risk locus of nonsynonymous SNP rs2043211 found in the European population did not show a significant association in our study.,"[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital of Harbin Medical University, Harbin 150081, China.'}, {'ForeName': 'Bingmei', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Heilongjiang Provincial Hospital, Harbin 150001, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Hao', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital of Harbin Medical University, Harbin 150081, China.'}, {'ForeName': 'Ronggui', 'Initials': 'R', 'LastName': 'Xing', 'Affiliation': 'Department of Dermatology, Heilongjiang Provincial Hospital, Harbin 150001, China.'}, {'ForeName': 'Yuzhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital of Harbin Medical University, Harbin 150081, China.'}]",BioMed research international,['10.1155/2020/2867505']
2661,32104689,Utility of Plasma GDF-15 for Diagnosis and Prognosis Assessment of ICU-Acquired Weakness in Mechanically Ventilated Patients: Prospective Observational Study.,"Objective


To identify the clinical correlations between plasma growth differentiation factor-15 (GDF-15), skeletal muscle function, and acute muscle wasting in ICU patients with mechanical ventilation. In addition, to investigate its diagnostic value for ICU-acquired weakness (ICU-AW) and its predictive value for 90-day survival in mechanically ventilated patients.
Methods


95 patients with acute respiratory failure, who required mechanical ventilation therapy, were randomly selected among hospitalized patients from June 2017 to January 2019. The plasma GDF-15 level was detected by ELISA, the rectus femoris cross-sectional area (RFcsa) was measured by ultrasound, and the patient's muscle strength was assessed using the British Medical Research Council (MRC) muscle strength score on day 1, day 4, and day 7. Patients were divided into an ICU-AW group and a non-ICU-AW group according to their MRC-score on the 7th day. The differences in plasma GDF-15 level, MRC-score, and RFcsa between the two groups were compared on the 1st, 4th, and 7th day after being admitted to the ICU. Then, the correlations between plasma GDF-15 level, RFcsa loss, and MRC-score on day 7 were investigated. The receiver operating characteristic curve (ROC) was used to analyze the plasma GDF-15 level, RFcsa loss, and % decrease in RFcsa on the 7th day to the diagnosis of ICU-AW in mechanically ventilated patients. Moreover, the predictive value of GDF-15 on the 90-day survival status of patients was assessed using patient survival curves.
Results


Based on whether the 7th day MRC-score was <48, 50 cases were included in the ICU-AW group and 45 cases in the non-ICU-AW group. The length of mechanical ventilation, ICU length of stay, and hospital length of stay were significantly longer in the ICU-AW group than in the non-ICU-AW group (all  P  < 0.05), while the other baseline indicators were not statistically significant between the two groups. As the treatment time increased, the plasma GDF-15 level was significantly increased, the ICU-AW group demonstrated a significant decreasing trend in the MRC-score and RFcsa, while no significant changes were found in the non-ICU-AW group. In the ICU-AW group, the plasma GDF-15 level was significantly higher than that in the non-ICU-AW group, while the RFcsa and the MRC-score were significantly lower than those in the non-ICU-AW group (GDF-15 (pg/ml): 2542.44 ± 629.38 vs. 1542.86 ± 502.86; RFcsa (cm 2 ): 2.04 ± 0.64 vs. 2.34 ± 0.61; MRC-score: 41.22 ± 3.42 vs. 51.42 ± 2.72, all  P  < 0.05), while the other baseline indicators were not statistically significant between the two groups. As the treatment time increased, the plasma GDF-15 level was significantly increased, the ICU-AW group demonstrated a significant decreasing trend in the MRC-score and RFcsa, while no significant changes were found in the non-ICU-AW group. In the ICU-AW group, the plasma GDF-15 level was significantly higher than that in the non-ICU-AW group, while the RFcsa and the MRC-score were significantly lower than those in the non-ICU-AW group (GDF-15 (pg/ml): 2542.44 ± 629.38 vs. 1542.86 ± 502.86; RFcsa (cm 2 ): 2.04 ± 0.64 vs. 2.34 ± 0.61; MRC-score: 41.22 ± 3.42 vs. 51.42 ± 2.72, all  r  = -0.60), while it was significantly positively correlated with the RFcsa loss ( r  = -0.60), while it was significantly positively correlated with the RFcsa loss ( r  = -0.60), while it was significantly positively correlated with the RFcsa loss ( r  = -0.60), while it was significantly positively correlated with the RFcsa loss ( P  < 0.05), while the other baseline indicators were not statistically significant between the two groups. As the treatment time increased, the plasma GDF-15 level was significantly increased, the ICU-AW group demonstrated a significant decreasing trend in the MRC-score and RFcsa, while no significant changes were found in the non-ICU-AW group. In the ICU-AW group, the plasma GDF-15 level was significantly higher than that in the non-ICU-AW group, while the RFcsa and the MRC-score were significantly lower than those in the non-ICU-AW group (GDF-15 (pg/ml): 2542.44 ± 629.38 vs. 1542.86 ± 502.86; RFcsa (cm 2 ): 2.04 ± 0.64 vs. 2.34 ± 0.61; MRC-score: 41.22 ± 3.42 vs. 51.42 ± 2.72, all  P  < 0.05), while the other baseline indicators were not statistically significant between the two groups. As the treatment time increased, the plasma GDF-15 level was significantly increased, the ICU-AW group demonstrated a significant decreasing trend in the MRC-score and RFcsa, while no significant changes were found in the non-ICU-AW group. In the ICU-AW group, the plasma GDF-15 level was significantly higher than that in the non-ICU-AW group, while the RFcsa and the MRC-score were significantly lower than those in the non-ICU-AW group (GDF-15 (pg/ml): 2542.44 ± 629.38 vs. 1542.86 ± 502.86; RFcsa (cm 2 ): 2.04 ± 0.64 vs. 2.34 ± 0.61; MRC-score: 41.22 ± 3.42 vs. 51.42 ± 2.72, all  P  < 0.05), while the other baseline indicators were not statistically significant between the two groups. As the treatment time increased, the plasma GDF-15 level was significantly increased, the ICU-AW group demonstrated a significant decreasing trend in the MRC-score and RFcsa, while no significant changes were found in the non-ICU-AW group. In the ICU-AW group, the plasma GDF-15 level was significantly higher than that in the non-ICU-AW group, while the RFcsa and the MRC-score were significantly lower than those in the non-ICU-AW group (GDF-15 (pg/ml): 2542.44 ± 629.38 vs. 1542.86 ± 502.86; RFcsa (cm 2 ): 2.04 ± 0.64 vs. 2.34 ± 0.61; MRC-score: 41.22 ± 3.42 vs. 51.42 ± 2.72, all.
Conclusion


The plasma GDF-15 concentration level was significantly associated with skeletal muscle function and muscle wasting on day 7 in ICU patients with mechanical ventilation. Therefore, it can be concluded that the plasma GDF-15 level on the 7th day has a high diagnostic yield for ICU-acquired muscle weakness, and it can predict the 90-day survival status of ICU mechanically ventilated patients.",2020,The plasma GDF-15 concentration level was significantly associated with skeletal muscle function and muscle wasting on day 7 in ICU patients with mechanical ventilation.,"['Mechanically Ventilated Patients', 'ICU patients with mechanical ventilation', '95 patients with acute respiratory failure, who required mechanical ventilation therapy, were randomly selected among hospitalized patients from June 2017 to January 2019', 'mechanically ventilated patients', 'ICU mechanically ventilated patients']","['Plasma GDF-15', 'ICU-AW group and a non-ICU-AW']","['plasma GDF-15 level, RFcsa loss, and MRC-score', 'plasma GDF-15 level, MRC-score, and RFcsa', 'RFcsa loss', 'RFcsa and the MRC-score', 'length of mechanical ventilation, ICU length of stay, and hospital length of stay', 'British Medical Research Council (MRC) muscle strength score', 'plasma GDF-15 concentration level', 'MRC-score and RFcsa', '90-day survival status', 'plasma GDF-15 level, RFcsa loss, and % decrease in RFcsa', 'plasma GDF-15 level', 'receiver operating characteristic curve (ROC']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",95.0,0.0149952,The plasma GDF-15 concentration level was significantly associated with skeletal muscle function and muscle wasting on day 7 in ICU patients with mechanical ventilation.,"[{'ForeName': 'Yongpeng', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ""Department of Critical Care Medicine, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang City, Lianyungang, China.""}, {'ForeName': 'Suxia', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang City, Lianyungang, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""Department of Critical Care Medicine, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang City, Lianyungang, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': ""Department of Critical Care Medicine, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang City, Lianyungang, China.""}, {'ForeName': 'Kexi', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Emergency Medicine, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang City, Lianyungang, China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Emergency Medicine, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang City, Lianyungang, China.""}]",BioMed research international,['10.1155/2020/3630568']
2662,31522631,The Relationship Between Clinician Turnover and Client Outcomes in Community Behavioral Health Settings.,"OBJECTIVE


High clinician turnover in community behavioral health settings can lead to increased costs and can have a negative impact on care quality. Few studies have examined the implications of clinician turnover for client outcomes. This study investigated changes in client outcomes associated with clinician turnover.
METHODS


The study used prospective observational data collected as part of a larger randomized controlled trial. Clients (N=328) from two community behavioral health centers identified the clinician (N=121) whom they saw most often. Clients completed measures of depression, anxiety, mental and physical health functioning, and patient activation at baseline, 6 months, and 12 months. Clinician turnover during the 12-month study was obtained from agency records. Latent growth curve modeling was used to analyze the data.
RESULTS


Of the 328 clients, 24% experienced clinician turnover. For all outcomes except depression, the association with turnover was moderated by baseline status on the outcome measure. Turnover tended to be associated with clinical decline for clients who at baseline had low to moderate anxiety, high patient activation, or high physical health functioning. Surprisingly, turnover was associated with increased mental health functioning for clients who at baseline had very low mental health functioning. For physical health functioning, the association with turnover was also moderated by age. Turnover was associated with a sharper decline in functioning for older clients.
CONCLUSIONS


Results suggest that clinician turnover was associated most strongly with decline for higher functioning or older clients, but it was not uniformly associated with worsening clinical outcomes.",2020,"Turnover tended to be associated with clinical decline for clients who at baseline had low to moderate anxiety, high patient activation, or high physical health functioning.","['Community Behavioral Health Settings', 'Clients (N=328) from two community behavioral health centers identified the clinician (N=121) whom they saw most often']",[],"['mental health functioning', 'depression, anxiety, mental and physical health functioning, and patient activation']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",328.0,0.0195358,"Turnover tended to be associated with clinical decline for clients who at baseline had low to moderate anxiety, high patient activation, or high physical health functioning.","[{'ForeName': 'Annalee', 'Initials': 'A', 'LastName': 'Johnson-Kwochka', 'Affiliation': 'Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis (Johnson-Kwochka, Wu, Luther, Fischer, Salyers); ACT (Assertive Community Treatment) Center of Indiana, Indianapolis (Wu, Salyers, Rollins); Center for Health Information and Communication, Richard L. Roudebush Veterans Affairs Medical Center (Rollins); Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston (Luther).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis (Johnson-Kwochka, Wu, Luther, Fischer, Salyers); ACT (Assertive Community Treatment) Center of Indiana, Indianapolis (Wu, Salyers, Rollins); Center for Health Information and Communication, Richard L. Roudebush Veterans Affairs Medical Center (Rollins); Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston (Luther).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Luther', 'Affiliation': 'Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis (Johnson-Kwochka, Wu, Luther, Fischer, Salyers); ACT (Assertive Community Treatment) Center of Indiana, Indianapolis (Wu, Salyers, Rollins); Center for Health Information and Communication, Richard L. Roudebush Veterans Affairs Medical Center (Rollins); Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston (Luther).'}, {'ForeName': 'Melanie W', 'Initials': 'MW', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis (Johnson-Kwochka, Wu, Luther, Fischer, Salyers); ACT (Assertive Community Treatment) Center of Indiana, Indianapolis (Wu, Salyers, Rollins); Center for Health Information and Communication, Richard L. Roudebush Veterans Affairs Medical Center (Rollins); Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston (Luther).'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Salyers', 'Affiliation': 'Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis (Johnson-Kwochka, Wu, Luther, Fischer, Salyers); ACT (Assertive Community Treatment) Center of Indiana, Indianapolis (Wu, Salyers, Rollins); Center for Health Information and Communication, Richard L. Roudebush Veterans Affairs Medical Center (Rollins); Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston (Luther).'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Rollins', 'Affiliation': 'Department of Psychology, School of Science, Indiana University-Purdue University Indianapolis, Indianapolis (Johnson-Kwochka, Wu, Luther, Fischer, Salyers); ACT (Assertive Community Treatment) Center of Indiana, Indianapolis (Wu, Salyers, Rollins); Center for Health Information and Communication, Richard L. Roudebush Veterans Affairs Medical Center (Rollins); Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston (Luther).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900169']
2663,31710398,Is topical alprostadil an usable and reliable alternative to intracavernous injection for penile dynamic duplex ultrasonography?,"No study has yet been done to evaluate topical alprostadil as a less invasive alternative vasoactive agent for Penile Dynamic Duplex Ultrasonography (PDDU) in the diagnosis of erectile dysfunction. The main aim of our study was to evaluate the usability and reliability of topical alprostadil for PDDU compared with standard intracavernous injection. A further objective was to determine the patients' preference between these two different approaches. During session A, patients received injection while during session B, they received topical alprostadil. Each patient underwent both sessions, 1 week apart from the other. A total of 80 patients were enrolled. After 20 min from drug administration, no significant difference was found between the two procedures in terms of peak systolic velocity and end-diastolic velocity, while Erection Hardness Score was significantly higher with injection. Patients reported less pain/discomfort during the procedure in case of topical alprostadil use and an overall preference towards this examination modality. Topical alprostadil could represent a usable and reliable alternative to intracavernous injection for PDDU, with less discomfort and greater preference by patients.",2020,"After 20 min from drug administration, no significant difference was found between the two procedures in terms of peak systolic velocity and end-diastolic velocity, while Erection Hardness Score was significantly higher with injection.",['80 patients were enrolled'],"['standard intracavernous injection', 'topical alprostadil']","['pain/discomfort', 'peak systolic velocity and end-diastolic velocity, while Erection Hardness Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456267', 'cui_str': 'Intracavernous injection'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C2960554', 'cui_str': 'Erection hardness score'}]",80.0,0.0558504,"After 20 min from drug administration, no significant difference was found between the two procedures in terms of peak systolic velocity and end-diastolic velocity, while Erection Hardness Score was significantly higher with injection.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Arcaniolo', 'Affiliation': 'Department of Woman, Child and General and Specialized Surgery, Urology Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bellastella', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Geriatric Sciences, Endocrinology and Metabolic Diseases Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Manfredi', 'Affiliation': 'Department of Woman, Child and General and Specialized Surgery, Urology Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Terribile', 'Affiliation': 'Department of Woman, Child and General and Specialized Surgery, Urology Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Dario Ranieri', 'Initials': 'DR', 'LastName': 'Giordano', 'Affiliation': 'Department of Woman, Child and General and Specialized Surgery, Urology Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Quattrone', 'Affiliation': 'Department of Woman, Child and General and Specialized Surgery, Urology Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'La Rocca', 'Affiliation': 'Department of Neurosciences, Reproductive Sciences, and Odontostomatology, Urology Unit, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'De Sio', 'Affiliation': 'Department of Woman, Child and General and Specialized Surgery, Urology Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Verze', 'Affiliation': 'Department of Neurosciences, Reproductive Sciences, and Odontostomatology, Urology Unit, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mirone', 'Affiliation': 'Department of Neurosciences, Reproductive Sciences, and Odontostomatology, Urology Unit, University of Naples ""Federico II"", Naples, Italy.'}]",Andrologia,['10.1111/and.13480']
2664,33217839,Pregnancy outcome treated with stage-by-stage acupuncture and moxibustion therapy based on the chong channel being sea of blood theory in repeated IVF-ET failure patients: A randomized controlled trial.,"INTRODUCTION


Acupuncture and moxibustion has become a commonly used adjuvant treatment method to improve the success rate of in vitro fertilization-embryo transfer (IVF-ET). However, There is still insufficient evidence that acupuncture treatment can improve the local microenvironment of endometrium, the endometrial receptivity, and the pregnancy outcome of patients, which is worthy of further study.
METHOD/DESIGN


To investigate the effect of Stage by Stage Acupuncture and Moxibustion Therapy on endometrial receptivity and Pregnancy Outcome based on the theory of ""Chong channel being sea of blood,"" we will conduct a multicenter randomized controlled trial. Inclusion criteria are as follows: infertile women under 45 years of age who received IVF-ET or Intracytoplasmic sperm injection cycles. The study will only be applied to women who have failed repeated implantation, that is, women who have failed 3 or more embryo transplants in the past (existing frozen embryos do not require the retrieval of eggs). Those who are not prepared to receive IVF-ET or are at risk of pregnancy, have a serious medical condition, or are egg donors will be excluded. Subjects will be randomly assigned to either the acupuncture group (IVF-ET plus stage-by-stage acupuncture and moxibustion therapy based on the ""Chong channel being sea of blood"" theory) or the control group (IVF-ET only). The trial required a total sample size of 246 women to compare endometrial receptivity between the 2 groups. The acupuncture group will receive acupuncture and moxibustion treatment 3 times a week starting from the third day of menstruation in the ovary stimulation cycle. One menstrual cycle was one course of treatment, and a total of 3 menstrual cycles were treated. The main outcome indicator was clinical pregnancy rate. Secondary outcome indicators were the three-dimensional volume blood flow parameters (vascularization index, flow index, and vascularization flow index) of the endometrium, endometrial thickness, endometrial volume, uterine artery PI, RI, and S/D during the ""implantation window period"" (20-24 days after menstruation in the ovary stimulation cycle).
DISCUSSION


This study will provide important evidence for the use of Stage by Stage Acupuncture and Moxibustion Therapy Based on the ""Chong Channel Being Sea of Blood"" Theory in IVF.
TRIAL REGISTRATION


http://www.chictr.org.cn/edit.aspx?pid=28811&htm=4 ID: ChiCTR1800017191 (07/17/2018).",2020,"Subjects will be randomly assigned to either the acupuncture group (IVF-ET plus stage-by-stage acupuncture and moxibustion therapy based on the ""Chong channel being sea of blood"" theory) or the control group (IVF-ET only).","['women who have failed repeated implantation, that is, women who have failed 3 or more embryo transplants in the past (existing frozen embryos do not require the retrieval of eggs', 'infertile women under 45 years of age who received IVF-ET or Intracytoplasmic sperm injection cycles', '246 women to compare endometrial receptivity between the 2 groups', 'in repeated IVF-ET failure patients']","['acupuncture', 'stage-by-stage acupuncture and moxibustion therapy based on the chong channel being sea of blood theory', 'acupuncture group (IVF-ET plus stage-by-stage acupuncture and moxibustion therapy based on the ""Chong channel being sea of blood"" theory', 'Acupuncture and Moxibustion Therapy', 'acupuncture and moxibustion', 'Acupuncture and moxibustion']","['clinical pregnancy rate', 'three-dimensional volume blood flow parameters (vascularization index, flow index, and vascularization flow index) of the endometrium, endometrial thickness, endometrial volume, uterine artery PI, RI, and S/D during the ""implantation window period', 'endometrial receptivity and Pregnancy Outcome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0440733', 'cui_str': 'Frozen embryo'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",246.0,0.147051,"Subjects will be randomly assigned to either the acupuncture group (IVF-ET plus stage-by-stage acupuncture and moxibustion therapy based on the ""Chong channel being sea of blood"" theory) or the control group (IVF-ET only).","[{'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Jinlong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Yunnan Second People's Hospital.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Yunxiu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Yunnan First People's Hospital.""}, {'ForeName': 'Haina', 'Initials': 'H', 'LastName': 'Zhuang', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Zhuojun', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan province, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Yunnan University of Traditional Chinese Medicine.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Yunnan First People's Hospital.""}]",Medicine,['10.1097/MD.0000000000023234']
2665,33217854,Nursing intervention reduces depression for patients with rheumatoid arthritis: A randomized controlled trial protocol.,"BACKGROUND


Rheumatoid arthritis (RA) is a kind of chronic disease of inflammatory joint, which can lead to the damage and disability of bone and cartilage. Psychiatric comorbidity is related to the adverse results of RA. Symptoms of depression is associated with the increased disease activity and decreased response to the treatments. Therefore, the depression may be an effective intervention target to improve the life quality and subjective health of the patients with RA. The objective of this experiment is to evaluate the effectiveness of nursing intervention for reducing depression for patients with RA.
METHOD


It is a single-center randomized controlled study to be conducted from January 2021 to December 2021. It was admitted via the Ethics Committee of Tianjin Medical University (202018384). One hundred patients are included in the study. The inclusion criteria contains:The exclusion criteria contains:All the patients participating in this study are randomly divided into control group and study group, with 50 patients in each group. The primary result is the severity of depression in the patients with RA, based on the generally utilized questionnaires (Hospital Anxiety and Depression Scale). The secondary outcome is the patients life quality, which is evaluated with the short form 36 questionnaire. The analysis of all the data are conducted with the software of IBM SPSS Statistics for Windows, version 20.
RESULTS


Table will show the clinical outcomes after various interventions.
CONCLUSION


This paper instructs the nurses to develop protocol based on evidence to improve the clinical efficacy for the RA patients.
TRIAL REGISTRATION NUMBER


researchregistry6114.",2020,"Therefore, the depression may be an effective intervention target to improve the life quality and subjective health of the patients with RA.","['patients with rheumatoid arthritis', 'January 2021 to December 2021', 'One hundred patients are included in the study', 'patients with RA']","['nursing intervention', 'Nursing intervention']","['utilized questionnaires (Hospital Anxiety and Depression Scale', 'life quality and subjective health', 'severity of depression', 'patients life quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.0463943,"Therefore, the depression may be an effective intervention target to improve the life quality and subjective health of the patients with RA.","[{'ForeName': 'Moying', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Baoxin', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023268']
2666,33217860,"Effectiveness of cognitive behavioral therapy on kinesiophobia and oral health-related quality of life in patients with temporomandibular disorders, study protocol for a randomized controlled trial.","BACKGROUND


Temporomandibular disorders (TMD) is a common physical and psychological disease in dental department. Pain and mandibular limitation are the main reasons for patients to seek oral treatment. However, the presence of kinesiophobia, patients often catastrophize pain, so as to avoid mandibular movement, which seriously affects their quality of life. Cognitive behavioral therapy (CBT) has significant improvements in reducing kinesiophobia and quality of life in musculoskeletal disease, but has not been proved in TMD patients. The study aims to apply CBT on kinesiophobia and oral health related quality of life (OHRQOL) in TMD patients.
METHODS


A total of 108 individuals between 18 and 65 years of age, who will be referred to the temporomandibular joint clinic of Stomatology Hospital of Tianjin Medical University in china will be randomized into 2 treatment arms. The control group will receive a conventional treatment, whereas the experiment group will receive CBT on the basis of the control group. The primary outcomes will be the kinesiophobia and OHRQOL, and will be measured by the Tampa scale for kinesiophobia for patients with Temporomandibular Disorders (TSK-TMD) and the Oral Health Impact Scale for patients with temporomandibular disorders (OHIP-TMDs), the secondary outcomes will be pain intensity measured by Numerical Rating Scale (NRS), pain catastrophizing measured by Pain Catastrophizing Scale (PCS), anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS), and self-efficacy measured by General Self-Efficacy Scale (GSES).
DISCUSSION


This study protocol reported a randomized controlled trial which aimed at assessing the effectiveness of the CBT versus conventional treatment with TMD.
TRIAL REGISTRATION


Registered in the Chinese Clinical Trial Registration Center with the number ChiCTR2000038573. Registered 24 September 2020.",2020,"Cognitive behavioral therapy (CBT) has significant improvements in reducing kinesiophobia and quality of life in musculoskeletal disease, but has not been proved in TMD patients.","['patients with temporomandibular disorders', 'TMD patients', '108 individuals between 18 and 65 years of age, who will be referred to the temporomandibular joint clinic of Stomatology Hospital of Tianjin Medical University in china']","['CBT', 'cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT']","['kinesiophobia and OHRQOL, and will be measured by the Tampa scale for kinesiophobia for patients with Temporomandibular Disorders (TSK-TMD) and the Oral Health Impact Scale', 'Pain and mandibular limitation', 'pain intensity measured by Numerical Rating Scale (NRS), pain catastrophizing measured by Pain Catastrophizing Scale (PCS), anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS), and self-efficacy measured by General Self-Efficacy Scale (GSES', 'kinesiophobia and oral health-related quality of life', 'kinesiophobia and oral health related quality of life (OHRQOL', 'kinesiophobia and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",108.0,0.116139,"Cognitive behavioral therapy (CBT) has significant improvements in reducing kinesiophobia and quality of life in musculoskeletal disease, but has not been proved in TMD patients.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Tianjin University of Traditional Chinese Medicine.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The TMJ Clinic, Stomatological Hospital of Tianjin Medical University.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Ran', 'Affiliation': 'School of Nursing, Tianjin University of Traditional Chinese Medicine.'}, {'ForeName': 'Shuipeng', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'School of Stomatology, Tianjin Medical University.'}, {'ForeName': 'Yingshu', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Nursing, Stomatological Hospital of Tianjin Medical University, Tianjin, China.'}]",Medicine,['10.1097/MD.0000000000023295']
2667,33217861,"The effectiveness of home-based therapy on functional outcome, self-efficacy and anxiety among discharged stroke survivors.","INTRODUCTION


Stroke survivors are commonly at risk of functional decline following discharge from rehabilitation, which increase their susceptibility to falls, dependency in activities of daily living and emotional disturbances. To combat these, continued therapy is important. Home-based therapy (HBT) has been shown to be useful in maintaining functional performance and quality of life of chronic stroke survivors. However, evidence on its effectiveness remains limited, while no studies are available to date which report the benefit of HBT on stroke survivors self-efficacy and emotional status. Therefore, this study aims to assess the effectiveness of post-discharge HBT in comparison to usual practice on functional outcome (mobility and gait speed), self-efficacy and anxiety level among stroke survivors.
METHODS


This is an assessor-blinded randomized control trial comparing 2 types of intervention which are HBT (experimental group) and usual practice (UP) (control group). Based on sample size calculation using GPower, a total number of 42 participants will be recruited and allocated into either the HBT or the UP group. Participants in HBT group will receive a set of structured exercise therapy consisting of progressive strengthening, balance and task-related exercises. While participants in UP group will receive a usual ""intervention"" practised by rehabilitation professional prior to discharging stroke patients from their care. Both groups are advised to perform the given interventions for 3 times per week for 12 weeks under the supervision of their caregiver. Outcomes of interventions will be measured using timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level). All data will be analyzed using descriptive and inferential statistics.
DISCUSSION


This study will provide the information on the effectiveness of HBT in comparison to UP among stroke population who are discharged from rehabilitation. Findings from the study will enable rehabilitation professionals to design effective discharge care plan for stroke survivors in combating functional decline when no longer receiving hospital-based therapy.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry, ACTRN12619001182189 (last updated 22/11/2019).",2020,"Therefore, this study aims to assess the effectiveness of post-discharge HBT in comparison to usual practice on functional outcome (mobility and gait speed), self-efficacy and anxiety level among stroke survivors.
","['discharged stroke survivors', '42 participants', 'stroke population who are discharged from rehabilitation']","['HBT (experimental group) and usual practice (UP) (control group', 'HBT', 'structured exercise therapy consisting of progressive strengthening, balance and task-related exercises', 'Home-based therapy (HBT', 'post-discharge HBT', 'home-based therapy', 'usual ""intervention"" practised by rehabilitation professional']","['functional outcome, self-efficacy and anxiety', 'functional outcome (mobility and gait speed), self-efficacy and anxiety level', 'timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}]",42.0,0.0548851,"Therefore, this study aims to assess the effectiveness of post-discharge HBT in comparison to usual practice on functional outcome (mobility and gait speed), self-efficacy and anxiety level among stroke survivors.
","[{'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Pui Kei', 'Affiliation': 'Physiotherapy Program, Center for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia.'}, {'ForeName': 'Nor Azlin', 'Initials': 'NA', 'LastName': 'Mohd Nordin', 'Affiliation': 'Physiotherapy Program, Center for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia.'}, {'ForeName': 'Aznida Firzah', 'Initials': 'AF', 'LastName': 'Abdul Aziz', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Cheras Kuala Lumpur, Malaysia.'}]",Medicine,['10.1097/MD.0000000000023296']
2668,33216623,"Effects of nutrition supplementation and physical exercise on muscle mass, muscle strength and fat mass among sarcopenic elderly: A randomized controlled trial.","This study aims to determine the impact of nutrition supplementation (whey protein, fish oil, vitamin D) and physical exercise (resistance and aerobic exercise) on muscle mass, muscle strength and fat mass among sarcopenic elderly. Participants (n=241) with sarcopenia (aged≥60y) enrolled from two centers were randomized into groups undergoing nutrition supplementation (Nutr), physical exercise (Ex), nutrition combined with exercise (Nutr+Ex), or routine consultation for 12 weeks. Muscle-related indicators, grip strength as well as fat-related indicators were compared pre- and post-intervention. The per-protocol analysis showed all indicators were significantly different between groups (P<0.001). Further pairwise comparisons showed that compared with controls, appendicular muscle mass and grip strength were significantly higher in Nutr (P<0.001, 95%CI:0.578,1.475; P<0.001, 95%CI:3.614~9.118), Ex (P=0.010, 95%CI: 0.157,1.153; P<0.001, 95%CI: 2.904,8.732), Nutr+Ex (P<0.001, 95%CI: 0.564,1.471; P<0.001, 95%CI: 3.441,8.907), while fat mass was significantly lower in the Nutr (P<0.001, 95%CI: -4.676,-2.358)) and Nutr+Ex (P<0.001, 95%CI: -4.717,-1.790). When compared with Ex, fat mass decreased significantly in Nutr (P=0.001, 95%CI: -4.856,-1.359)) and Nutr+Ex (P=0.005, 95%CI: -4.810,-0.878). The findings indicate that nutrition supplementation and physical exercise could improve muscle mass, strength and fat mass among sarcopenic elderly. Nutrition supplementation might be better at decreasing fat mass in this population. Trial registration number: NCT02873676. Novelty: ● Nutrition supplementation improved muscle mass, strength and fat mass among sarcopenic elderly. ● Aerobic and resistance exercise improved muscle mass and strength in sarcopenic elderly. ● Combined nutrition supplementation and physical exercise improved muscle mass, strength and fat mass among sarcopenic elderly.",2020,"When compared with Ex, fat mass decreased significantly in Nutr (P=0.001, 95%CI: -4.856,-1.359)) and Nutr+Ex (P=0.005, 95%CI: -4.810,-0.878).","['Participants (n=241) with sarcopenia (aged≥60y) enrolled from two centers', 'sarcopenic elderly']","['● Combined nutrition supplementation and physical exercise', 'nutrition supplementation (whey protein, fish oil, vitamin D) and physical exercise (resistance and aerobic exercise', 'Nutrition supplementation', '● Nutrition supplementation', 'nutrition supplementation and physical exercise', 'nutrition supplementation (Nutr), physical exercise (Ex), nutrition combined with exercise (Nutr+Ex), or routine consultation for 12 weeks', '● Aerobic and resistance exercise']","['fat mass', 'Novelty', 'appendicular muscle mass and grip strength', 'muscle mass, strength and fat mass', 'muscle mass, muscle strength and fat mass']","[{'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",241.0,0.14516,"When compared with Ex, fat mass decreased significantly in Nutr (P=0.001, 95%CI: -4.856,-1.359)) and Nutr+Ex (P=0.005, 95%CI: -4.810,-0.878).","[{'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China; 18186943979@163.com.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cui', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China; cm013971@163.com.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China; yuk1997@sina.com.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Hebei General Hospital, 117872, Shijiazhuang, Hebei, China; 1920369319@qq.com.'}, {'ForeName': 'Chunwei', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China; xinxinyuweiwei@sina.com.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Nie', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China; xiaodongnie@126.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, China; yours.fang@hotmail.com.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0643']
2669,33216632,"Effects of Korean Red Ginseng ( Panax ginseng  C.A. Meyer) on Menopausal Symptoms in Premenopausal Women After Gynecologic Cancer Surgery: A Double-Blind, Randomized Controlled Trial.","Objectives:  Korean red ginseng (KRG) has been widely used as an alternative medicine to relieve menopausal symptoms. However, there is still a lack of clinical studies showing the effects of KRG on menopausal symptoms after gynecologic cancer surgery. Therefore, the authors investigated the effects of KRG on surgical menopause symptoms in premenopausal women with gynecologic cancer.  Design:  A double-blind, randomized, placebo-controlled clinical trial was conducted.  Settings/Location:  The study was performed at Severance Hospital at the Yonsei University College of Medicine in Seoul, Korea.  Subjects:  Fifty-five premenopausal women diagnosed with gynecologic cancer were enrolled in the study.  Interventions:  Patients were randomly assigned to a KRG ( n  = 29) or a placebo control group ( n  = 26). Subjects were administered either KRG (a total of 3 g per day) or placebo supplements for 12 weeks.  Outcome measures:  Patients' physical measurements (height, weight, and blood pressure) and blood samples (lipid profiles, hormone profiles, biochemical profiles, and neutrophil-to-lymphocyte ratio) at baseline and at 12 weeks were compared. Changes in menopausal symptoms based on the Menopause Rating Scale (MRS) were also compared between these two time points and two groups.  Results:  After 12 weeks, the MRS score was significantly reduced in each group ( p  = 0.001 and  p  = 0.001, respectively), but there were no significant differences between the two groups ( p  = 0.661). No adverse events were observed in either group. After comparing 11 MRS symptoms between the two groups, the KRG group seemed to be superior to the placebo group on the subscale of sexual complaints ( p  < 0.05).  Conclusions:  Through the study, KRG did not show absolute relief of surgical menopause symptoms in premenopausal women after gynecologic cancer surgery. However, the study did demonstrate that KRG may be effective in reducing sexual complaints. Further studies are required to evaluate the long-term effects of KRG in a larger patient population.",2020,", KRG did not show absolute relief of surgical menopause symptoms in premenopausal women after gynecologic cancer surgery.","['Premenopausal Women', 'premenopausal women after gynecologic cancer surgery', 'Subjects:  Fifty-five premenopausal women diagnosed with gynecologic cancer were enrolled in the study', 'After Gynecologic Cancer Surgery', 'Severance Hospital at the Yonsei University College of Medicine in Seoul, Korea', 'premenopausal women with gynecologic cancer']","['placebo control', 'KRG', 'placebo', 'Korean Red Ginseng ( Panax ginseng  C.A. Meyer', 'placebo supplements', 'Korean red ginseng (KRG']","['menopausal symptoms', 'sexual complaints', 'MRS score', ""Outcome measures:  Patients' physical measurements (height, weight, and blood pressure) and blood samples (lipid profiles, hormone profiles, biochemical profiles, and neutrophil-to-lymphocyte ratio"", 'surgical menopause symptoms', 'Menopausal Symptoms', 'adverse events', 'Menopause Rating Scale (MRS', 'subscale of sexual complaints']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0740421', 'cui_str': 'Postsurgical menopause'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",55.0,0.509497,", KRG did not show absolute relief of surgical menopause symptoms in premenopausal women after gynecologic cancer surgery.","[{'ForeName': 'Young Shin', 'Initials': 'YS', 'LastName': 'Chung', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'In Ok', 'Initials': 'IO', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Korea.'}, {'ForeName': 'Jung-Yun', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Eun Ji', 'Initials': 'EJ', 'LastName': 'Nam', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Sang Wun', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Young Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Sunghoon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.""}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0429']
2670,33216664,Evaluation of the feasibility of an error-minimized approach to powered wheelchair skills training using shared control.,"BACKGROUND


Powered wheelchairs promote participation for people with mobility limitations. For older adults with cognitive impairment, existing training methods may not address learning needs, leading to difficulty with powered wheelchair skills. Error-minimized training, facilitated by shared control technology, may provide learning opportunities more suited to this population.
OBJECTIVE


The objective of this study was to evaluate the feasibility of an error-minimized approach to powered wheelchair skills training using shared control in residential care. Feasibility indicators were hypothesized a priori to be feasible for use in a definitive RCT.
METHODS


A 2 × 2 factorial RCT compared an error-minimized powered wheelchair skills training program (Co-pilot) to a control intervention at two doses (6 sessions vs. 12 sessions). Data were collected on the feasibility of study processes (e.g., recruitment), resources (e.g., participant time), management (e.g., technology reliability), and training outcomes (e.g., adverse events, clinical outcomes).
RESULTS


Twenty-five older adults with cognitive impairment participated in the study. Technical issues were encountered in 14.5% of training sessions. Participants receiving 6 sessions of training adhered better to the treatment than those receiving 12 sessions. All participants learned the skills required for PWC use with minor errors, regardless of the training method or dose. Co-pilot participants and trainers reported feelings of safety and training benefits with the use of shared control technology.
CONCLUSIONS


Individuals with mild to moderate cognitive impairment are able to learn the skills required to drive a powered wheelchair in as few as six training sessions. Further evaluation of the Co-pilot training program is required. IMPLICATIONS FOR REHABILITATION Shared control teleoperation technology may be used to augment learning in older adults with cognitive impairments. Evaluation of the feasibility of use of novel rehabilitation technologies is critical prior to engaging in large-scale clinical research. Individuals with cognitive impairment are able to learn the required skills for operation of a powered wheelchair.",2020,Participants receiving 6 sessions of training adhered better to the treatment than those receiving 12 sessions.,"['people with mobility limitations', 'Twenty-five older adults with cognitive impairment participated in the study', 'older adults with cognitive impairment', 'Individuals with cognitive impairment', 'Individuals with mild to moderate cognitive impairment', 'older adults with cognitive impairments', 'residential care']","['error-minimized approach to powered wheelchair skills training', 'wheelchair skills training', 'novel rehabilitation technologies']","['training outcomes (e.g., adverse events, clinical outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1565249', 'cui_str': 'Mobility Limitation'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C2092170', 'cui_str': 'Motorized wheelchair device'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",25.0,0.0328814,Participants receiving 6 sessions of training adhered better to the treatment than those receiving 12 sessions.,"[{'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Smith', 'Affiliation': 'Assisting Living and Learning (ALL) Institute, Maynooth University, Maynooth, Ireland.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'GF Strong Rehabilitation Research Program, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Mitchell', 'Affiliation': 'Department of Computer Science, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'W Ben', 'Initials': 'WB', 'LastName': 'Mortenson', 'Affiliation': 'GF Strong Rehabilitation Research Program, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mihailidis', 'Affiliation': 'Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Canada.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1849434']
2671,33216667,Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop (iDCL) Trial.,"OBJECTIVE


To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS


Pre-specified sub-analysis of outcomes in adolescents and young adults 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for six months.
RESULTS


Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in Range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 hours/day]; 95% CI 9% to 16%, P<0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference -12% [-2.9 hours/day], P<0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference -0.7% [-10 min/day], 95% CI -1.0% to -0.2%, P=0.002). CLC use averaged 89% of the time over 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC vs. SAP (95% CI -0.67 to +0.08, P=0.13). There was one DKA episode in the CLC group.
CONCLUSIONS


CLC use over 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group.",2020,CLC use over 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes.,"['Adolescents and Young Adults', 'adolescents and young adults 14-24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial', 'adolescents and young adults with type 1 diabetes', 'Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1']","['closed-loop control (CLC) insulin delivery system', 'CLC', 'Closed-Loop Insulin Therapy', 'CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM']","['glycemic outcomes', 'Time in Range (TIR', 'efficacy and safety', 'TIR and reduced hypoglycemia']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517875', 'cui_str': '8.1'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.131632,CLC use over 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes.,"[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Isganaitis', 'Affiliation': 'Joslin Diabetes Center, 10577, Boston, Massachusetts, United States.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Raghinaru', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, United States; draghinaru@Jaeb.org.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ambler-Osborn', 'Affiliation': 'Joslin Diabetes Center, Section on Clinical, Behavioral and Outcomes Research, Boston, Massachusetts, United States; louise.ambler-osborn@joslin.harvard.edu.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Pinsker', 'Affiliation': 'Sansum Diabetes Research Institute, 2219 Bath St., Santa Barbara, California, United States, 93105; jpinsker@sansum.org.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Stanford University, 300 Pasteur Drive, g-313, Stanford, California, United States, 943085; bbendo@stanford.edu.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'University of Colorado - Anschutz Medical Campus, 129263, Barbara Davis Center for Diabetes, 1775 Aurora Court, Aurora, Colorado, United States, 80045-2559; PAUL.WADWA@CUANSCHUTZ.EDU.'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': ""Stanford University School of Medicine, 10624, Lucile Packard Children's Hospital - Pediatric Endocrinology, 780 Welch Road, 3rd floor, Palo Alto, California, United States, 94304; layae@stanford.edu.""}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Mayo Clinic , Endocrinology, W 18 A Mayo Building, Rochester, United States, 55905.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Mt Sinai, Endocrinology, 1 Gustave L Levy Place, Box 1055, NY, New York, United States, 10029; carol.levy@mssm.edu.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'University of Colorado Denver, 12226, Barbara Davis Center for Childhood Diabetes, 1775 Aurora Court, A140, Denver, Colorado, United States, 80204; gregory.forlenza@cuanschutz.edu.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, Florida, United States, 33647; rbeck@jaeb.org.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kollman', 'Affiliation': 'Jaeb Center for Health Research, Biostatistics, 15310 Amberly Dr, Suite 350, Tampa, Florida, United States, 33647; ckollman@jaeb.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lum', 'Affiliation': 'Jaeb Centre for Health Research, 371336, 15310 Amberly Dr, SUite 350, Tampa, Florida, United States, 33647-1642; jl_manuscripts@jaeb.org.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'University of Virginia Health System, 12350, Charlottesville, Virginia, United States; SAB2F@hscmail.mcc.virginia.edu.'}, {'ForeName': 'Lori Mb', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Pediatric, Adolescent, and Young Adult Section, One Joslin Place, Boston, Massachusetts, United States, 02215; lori.laffel@joslin.harvard.edu.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0572']
2672,33217031,"Pre-Procedure Intravenous Lidocaine Administration on Propofol Consumption for ERCP: A Prospective, Randomized, Double-Blind Study.","BACKGROUND AND AIM


The endoscopic retrograde cholangiopancreatography (ERCP) procedure is generally performed in patients with high comorbidity. We aimed to reduce the consumption of propofol by adding lidocaine before ERCP.
METHODS


Eighty ERCP patients with ASA I-III, aged between 45-75 years, were randomly divided into two groups. Lidocaine group (Group L,n=40), received 1mg midazolam, 1.5 mg/kg lidocaine, and 1 mg/kg propofol intravenously. The control group (Group C,n=40) received 1 mg midazolam, saline in the same volume as the lidocaine group, and 1 mg/kg propofol intravenously. Propofol was administered with intermittent bolus doses. Propofol consumption, oropharyngeal reflex, recovery time, endoscopist satisfaction, ketamine need, and side effects were recorded.
RESULTS


Propofol consumption during the procedure was statistically lower in Group L than in the control group (157.25±39.16 mg vs. 228.75±64.62 mg respectively, p<0.001). Additionally, recovery time was statistically faster in group L compared to the control group (7.78±3.95 min vs. 11.92±3.24 min respectively, p<0.001). The oropharyngeal reflex was less in Group L than control group (6/40 vs. 15/40 respectively, p=0.042). There was no significant difference between the two groups regarding VAS scores and endoscopist satisfaction (p>0.05).
CONCLUSIONS


We recommend the use of intravenous lidocaine before the ERCP procedure as it reduces propofol consumption, recovery times, and oropharyngeal reflex.",2020,"There was no significant difference between the two groups regarding VAS scores and endoscopist satisfaction (p>0.05).
","['ERCP', 'Eighty ERCP patients with ASA I-III, aged between 45-75 years', 'patients with high comorbidity']","['lidocaine', 'midazolam, 1.5 mg/kg lidocaine, and 1 mg/kg propofol intravenously', 'midazolam, saline', 'Propofol', 'Lidocaine', 'endoscopic retrograde cholangiopancreatography (ERCP) procedure']","['VAS scores and endoscopist satisfaction', 'propofol consumption, recovery times, and oropharyngeal reflex', 'oropharyngeal reflex', 'recovery time', 'Propofol consumption, oropharyngeal reflex, recovery time, endoscopist satisfaction, ketamine need, and side effects']","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",80.0,0.0511522,"There was no significant difference between the two groups regarding VAS scores and endoscopist satisfaction (p>0.05).
","[{'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Ates', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Albayrak', 'Affiliation': 'Department of Gastroenterology, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Disci', 'Affiliation': 'Department of General Surgery, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Elif Oral', 'Initials': 'EO', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Baran', 'Affiliation': 'Department of Anesthesiology and Reanimation, Palandoken State Hospital, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ataturk University School of Medicine, Erzurum, Turkey.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15356']
2673,33217050,Effects of Korean red ginseng on human gray matter volume and cognitive function: A voxel-based morphometry study.,"OBJECTIVE


We aimed to investigate the effects of Korean red ginseng (KRG) supplementation on gray matter volume of the human brain which could be related to cognitive enhancing effects of KRG.
METHODS


In this randomized, double-blind, placebo-controlled study, 51 healthy individuals were assigned to receive either KRG (1000 mg/day, n = 26) or placebo (n = 25) for 8 weeks. Gray matter volume of the whole brain was measured using voxel-based morphometry based on high-resolution T1-weighted magnetic resonance images acquired at baseline and week 8. The standardized composite cognitive scores of executive function, attention, and memory were also evaluated at baseline and week 8. Changes in gray matter volume as well as the composite cognitive scores were compared between the KRG and placebo groups.
RESULTS


Following 8 weeks of KRG supplementation, the gray matter volume of the left parahippocampal gyrus increased significantly in the KRG group, relative to the placebo group (p for interaction < 0.001). The KRG group also showed greater magnitude of enhancement in the composite cognitive scores relative to the placebo group (p for interaction = 0.03).
CONCLUSIONS


Gray matter volume increase in the parahippocampus may be a key neural change as induced by KRG supplementation, which could be associated with cognitive enhancement.",2020,"Following 8 weeks of KRG supplementation, the gray matter volume of the left parahippocampal gyrus increased significantly in the KRG group, relative to the placebo group (p for interaction < 0.001).",['51 healthy individuals'],"['Korean red ginseng', 'Korean red ginseng (KRG) supplementation', 'KRG', 'placebo']","['gray matter volume', 'composite cognitive scores', 'human gray matter volume and cognitive function', 'gray matter volume of the left parahippocampal gyrus', 'standardized composite cognitive scores of executive function, attention, and memory']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0228249', 'cui_str': 'Structure of parahippocampal gyrus'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",51.0,0.333506,"Following 8 weeks of KRG supplementation, the gray matter volume of the left parahippocampal gyrus increased significantly in the KRG group, relative to the placebo group (p for interaction < 0.001).","[{'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Hyeonseok', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Gahae', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Myeongju', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Rye Young', 'Initials': 'RY', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Shinhye', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'In Kyoon', 'Initials': 'IK', 'LastName': 'Lyoo', 'Affiliation': 'Ewha Brain Institute, Ewha Womans University, Seoul, South Korea.'}]",Human psychopharmacology,['10.1002/hup.2767']
2674,33217054,Lenvatinib is independently associated with the reduced risk of progressive disease when compared to sorafenib in patients with advanced hepatocellular carcinoma.,"BACKGROUND/AIMS


Recently, lenvatinib demonstrated non-inferiority to sorafenib in terms of overall survival (OS) in a randomized phase III study that was conducted at 154 sites in 20 countries. Here, we investigated treatment outcomes and safety of lenvatinib compared to sorafenib and identified independent predictors of poor outcomes, including shorter progression-free survival (PFS) and OS in Korean patients with unresectable HCC.
METHODS


Patients with advanced HCC treated with lenvatinib or sorafenib at Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine between October 2018 to October 2019, were considered eligible. Response evaluation was performed according to the modified RECIST criteria.
RESULTS


The lenvatinib arm had a significantly lower proportion of patients who received prior anti-HCC treatments (47.7% vs. 78.7%; P<0.001) than those in the sorafenib arm. Univariate analysis showed that ECOG 1 (vs. 0), serum albumin, AFP, previous anti-HCC treatments, and lenvatinib (vs. sorafenib) were significant predictors of progressive disease (all P<0.05). In the subsequent multivariate analysis, ECOG 1 (vs. 0) (hazard ratio [HR]=4.721, 95% confidence interval [CI] 1.371-16.259; P=0.014), higher AFP level (HR=1.000, 95% CI 1.000-1.000; P=0.015), and lenvatinib treatment (vs. sorafenib) (HR=0.461, 95% CI 0.264-0.804; P=0.006) independently predicted a higher probability of progressive disease.
CONCLUSIONS


Patients treated with lenvatinib demonstrated significantly longer PFS than those treated with sorafenib. Furthermore, no significant differences were observed in mortality rates between the two groups, which indicated that lenvatinib is non-inferior to sorafenib in terms of OS.",2020,"Univariate analysis showed that ECOG 1 (vs. 0), serum albumin, AFP, previous anti-HCC treatments, and lenvatinib (vs. sorafenib) were significant predictors of progressive disease (all P<0.05).","['Korean patients with unresectable HCC', 'Patients with advanced HCC treated with lenvatinib or sorafenib at Yonsei Liver Center, Severance Hospital, Yonsei University College of Medicine between October 2018 to October 2019, were considered eligible', 'patients with advanced hepatocellular carcinoma']",['sorafenib'],"['shorter progression-free survival (PFS) and OS', 'PFS', 'mortality rates', 'higher AFP level', 'overall survival (OS', 'serum albumin, AFP, previous anti-HCC treatments, and lenvatinib']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0201539', 'cui_str': 'Alpha-1-Fetoprotein measurement'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2986924', 'cui_str': 'lenvatinib'}]",,0.0951883,"Univariate analysis showed that ECOG 1 (vs. 0), serum albumin, AFP, previous anti-HCC treatments, and lenvatinib (vs. sorafenib) were significant predictors of progressive disease (all P<0.05).","[{'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Hyun', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Beom Kyung', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Up', 'Initials': 'SU', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15355']
2675,33217058,Soft tissue contour and radiographic evaluation of ridge preservation in early implant placement: A randomized controlled clinical trial.,"OBJECTIVES


To compare two ridge preservation techniques and spontaneous healing in terms of hard and soft tissue changes 2 months after tooth extraction.
MATERIAL AND METHODS


The study was designed as a randomized controlled trial and included 75 patients. After single tooth extraction in the maxillary incisor/premolar area, patients were randomly allocated to one of the following groups: 1) ridge preservation with a xenogeneic bone substitute covered with a collagen matrix (CM-group), 2) ridge preservation with a xenogeneic bone substitute covered with a free palatal graft (PG-group) or 3) spontaneous healing (control). Eight weeks after tooth extraction, implants were placed and clinical, profilometric and radiographic evaluations were performed. In addition, the need for further guided bone regeneration (GBR) at implant placement was assessed. The differences between the treatment groups were compared with the One-way ANOVA or Kruskal-Wallis test with the corresponding post hoc analysis. The proportions of the categorical parameters were compared with the Fisher´s exact test.
RESULTS


Seventy-five patients underwent early implant placement 8 weeks after tooth extraction and were evaluated. CM-group (-0.9 SD 0.6 mm) and PG-group (-1.0 SD 0.8 mm) showed less horizontal bone resorption compared to the control group (-3.2 SD 2.1 mm) (p<.001). Moreover, the necessity of GBR at implant placement was significantly less in CM-group (32%) and PG-group (24%) when compared to control group (72%) (p=.001). Patients in CM-group experienced less pain than PG-group, one week after tooth extraction (p=.042). No significant differences were found regarding graft evaluation, post-operative complications and soft tissue contour.
CONCLUSIONS


Ridge preservation using a xenogeneic bone substitute covered with a collagen matrix or a palatal graft, results in less bone resorption and fewer GBR procedures at early implant placement compared to spontaneous healing.",2020,"Patients in CM-group experienced less pain than PG-group, one week after tooth extraction (p=.042).","['included 75 patients', 'early implant placement']","['ridge preservation with a xenogeneic bone substitute covered with a collagen matrix (CM-group), 2) ridge preservation with a xenogeneic bone substitute covered with a free palatal graft (PG-group) or 3) spontaneous healing (control']","['graft evaluation, post-operative complications and soft tissue contour', 'horizontal bone resorption', 'bone resorption and fewer GBR procedures', 'necessity of GBR at implant placement', 'pain']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.0714752,"Patients in CM-group experienced less pain than PG-group, one week after tooth extraction (p=.042).","[{'ForeName': 'B P', 'Initials': 'BP', 'LastName': 'Jonker', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Special Dental Care and Orthodontics, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gil', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Naenni', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Wolvius', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Special Dental Care and Orthodontics, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pijpe', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Special Dental Care and Orthodontics, Erasmus University Medical Center, Rotterdam, the Netherlands.'}]",Clinical oral implants research,['10.1111/clr.13686']
2676,33217124,"Our reaction on the comment of Yosiko Myoken et al. on ""The effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene: A Randomized Controlled Trial by Scheerman et al.""","Our reaction on the letter of Yosiko Myoken et al.(2020): Yosiko Myoken et al. commented on our article about the effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene  2  . Although they commended our article, they raised some questions that we would like to respond to. First, Myoken et al. believed that we should have evaluated the effectiveness of our intervention over a longer study period of at least six months to obtain accurate results.",2020,"commented on our article about the effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene  2  .",[],"['mobile application (""WhiteTeeth']",['oral hygiene'],[],"[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}]",,0.0207079,"commented on our article about the effect of using a mobile application (""WhiteTeeth"") on improving oral hygiene  2  .","[{'ForeName': 'Janneke F M', 'Initials': 'JFM', 'LastName': 'Scheerman', 'Affiliation': 'Inholland University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Berno', 'Initials': 'B', 'LastName': 'van Meijel', 'Affiliation': 'Inholland University of Applied Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van Empelen', 'Affiliation': 'TNO Research Group, Leiden, The Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Cor', 'Initials': 'C', 'LastName': 'van Loveren', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'VU Medical Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Amsterdam Public Health Research Institute (EMGO), Amsterdam, The Netherlands.'}, {'ForeName': 'Matheus C T', 'Initials': 'MCT', 'LastName': 'van den Braak', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gem J C', 'Initials': 'GJC', 'LastName': 'Kramer', 'Affiliation': 'Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands.'}]",International journal of dental hygiene,['10.1111/idh.12482']
2677,33217147,Blood markers in remote ischaemic conditioning for acute ischaemic stroke: data from the REmote ischaemic Conditioning After Stroke Trial.,"BACKGROUND


Remote ischaemic per-conditioning (RIC) is neuroprotective in experimental ischaemic stroke. Several neurohumoral, vascular and inflammatory mediators are implicated. We assessed the effect of RIC on plasma biomarkers using clinical data from the REmote ischaemic Conditioning After Stroke Trial (RECAST-1).
METHODS


RECAST-1 was a pilot sham-controlled blinded trial in 26 patients with ischaemic stroke, randomised to receive four 5-minute cycles of RIC within 24 hours of ictus. Plasma taken pre-intervention, immediately post-intervention and on day 4 was analysed for nitric oxide (nitrate/nitrite) using chemiluminescence and all other biomarkers by multiplex analysis. Biomarkers were correlated with clinical outcome (day 90 National Institutes of Health Stroke Scale [NIHSS], modified Rankin scale [mRS], Barthel index [BI]).
RESULTS


RIC reduced serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels from pre- to post-intervention (n=13, 2-way ANOVA, p<0.05). Overall (n=26), increases in SAP pre- to post intervention and pre-intervention to day 4 were moderately-correlated with worse day 90 clinical outcomes. No consistent significant changes over time, or by treatment, or correlations with outcome were seen for other biomarkers.
CONCLUSIONS


RIC reduced SAP and TNF-α levels from pre- to post-intervention. Increases in plasma levels of SAP were associated with worse clinical outcomes after ischaemic stroke. Larger studies assessing biomarkers, safety and efficacy of RIC in acute ischaemic stroke are warranted to further understand these relationships.",2020,"RESULTS


RIC reduced serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels from pre- to post-intervention (n=13, 2-way ANOVA, p<0.05).","['acute ischaemic stroke', '26 patients with ischaemic stroke']","['Remote ischaemic per-conditioning (RIC', 'RIC']","['serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels', 'plasma levels of SAP', 'SAP and TNF-α levels', 'Blood markers', 'Health Stroke Scale [NIHSS], modified Rankin scale [mRS], Barthel index [BI', 'SAP pre']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0311444', 'cui_str': 'Serum amyloid protein'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",26.0,0.120839,"RESULTS


RIC reduced serum amyloid protein (SAP) and tissue necrosis factor-α (TNF-α) levels from pre- to post-intervention (n=13, 2-way ANOVA, p<0.05).","[{'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Appleton', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Vascular Medicine, Division of Medical Sciences and GEM, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hedstrom', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences and GEM, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'May', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Donnelly', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences and GEM, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences and GEM, School of Medicine, University of Nottingham, Derby, UK.'}]",European journal of neurology,['10.1111/ene.14650']
2678,33219673,Neighbourhood walkability and physical activity: moderating role of a physical activity intervention in overweight and obese older adults with metabolic syndrome.,"BACKGROUND


While urban built environments might promote active ageing, an infrequently studied question is how the neighbourhood walkability modulates physical activity changes during a physical activity intervention programme in older adults. We assessed the influence of objectively assessed neighbourhood walkability on the change in physical activity during the intervention programme used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial.
METHOD


The present study involved 228 PREDIMED-Plus senior participants aged between 55 and 75, recruited in Palma de Mallorca (Spain). Overweight/obese older adults with metabolic syndrome were randomised to an intensive weight-loss lifestyle intervention or a control group. A walkability index (residential density, land use mix, intersections density) was calculated using geographic information systems (1 km sausage-network buffer). Physical activity was assessed using accelerometer and a validated questionnaire, at baseline and two follow-up visits (6-months and 1-year later). Generalised additive mixed models were fitted to estimate the association between the neighbourhood walkability index and changes in physical activity during follow-up.
RESULTS


Higher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (β = 3.44; 95% CI = 0.52; 6.36 min/day). When analyses were stratified by intervention arm, the association was only observed in the intervention group (β = 6.357; 95% CI = 2.07;10.64 min/day) (P for interaction = 0.055).
CONCLUSIONS


The results indicate that the walkability of the neighbourhood could support a physical activity intervention, helping to maintain or increase older adults' physical activity.",2020,"RESULTS


Higher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (β = 3.44; 95% CI = 0.52; 6.36 min/day).","['228 PREDIMED-Plus senior participants aged between 55 and 75, recruited in Palma de Mallorca (Spain', 'older adults', 'Overweight/obese older adults with metabolic syndrome', 'overweight and obese older adults with metabolic syndrome']","['Neighbourhood walkability and physical activity', 'physical activity intervention', 'intensive weight-loss lifestyle intervention or a control group']","['physical activity duration', ""older adults' physical activity"", 'physical activity', 'Physical activity', 'walkability index (residential density, land use mix, intersections density']","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0454825', 'cui_str': 'Mallorca'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]",228.0,0.0310212,"RESULTS


Higher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (β = 3.44; 95% CI = 0.52; 6.36 min/day).","[{'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Colom', 'Affiliation': 'Research Group on Nutritional Epidemiology & Cardiovascular Physiopathology, Health Research Institute of the Balearic Islands (IdISBa). University Hospital Son Espases, 07120 Palma, Spain.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Mavoa', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Maurici', 'Initials': 'M', 'LastName': 'Ruiz', 'Affiliation': 'Research Group on Nutritional Epidemiology & Cardiovascular Physiopathology, Health Research Institute of the Balearic Islands (IdISBa). University Hospital Son Espases, 07120 Palma, Spain.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wärnberg', 'Affiliation': 'Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Muncunill', 'Affiliation': 'Genomics and Bioinformatics Platform, Balearic Islands Health Research Institute (IdISBa), University Hospital Son Espases, Palma, Spain.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Konieczna', 'Affiliation': 'Research Group on Nutritional Epidemiology & Cardiovascular Physiopathology, Health Research Institute of the Balearic Islands (IdISBa). University Hospital Son Espases, 07120 Palma, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Vich', 'Affiliation': 'Geography Department, Autonomous University of Barcelona, Bellaterra, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Barón-López', 'Affiliation': 'Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Consorcio CIBER, M.P. Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'Research Group on Nutritional Epidemiology & Cardiovascular Physiopathology, Health Research Institute of the Balearic Islands (IdISBa). University Hospital Son Espases, 07120 Palma, Spain.'}]",Age and ageing,['10.1093/ageing/afaa246']
2679,33219706,Constraint-induced movement therapy for children with neonatal brachial plexus palsy: a randomized crossover trial.,"AIM


To determine if constraint-induced movement therapy (CIMT) is more effective than standard care in improving upper-limb activity outcomes in children with neonatal brachial plexus palsy (NBPP).
METHOD


Twenty-one children with NBPP (mean age 25mo, SD=10.3, range=17-48mo; 11 males, 10 females) were enrolled in a crossover trial and randomly allocated to first receive CIMT or standard care, each for 8 weeks. The intervention arm consisted of 3 weeks of casting the unaffected limb followed by 5 weeks of transference activities. The Assisting Hand Assessment (AHA) was used to measure bimanual activity performance at baseline, 8 weeks, and 16 weeks, scored by blinded raters. The Pediatric Motor Activity Log-Revised (PMAL-R) was used as a caregiver-reported secondary outcome measure.
RESULTS


After concealed random allocation (n=21), there were no significant differences on demographics or baseline measures. CIMT was superior compared to control in terms of bimanual activity performance with a mean difference in AHA change score of 4.8 (SD=10.5, p=0.04, Cohen's δ=0.46). There were no significant differences between treatment conditions on the PMAL-R.
INTERPRETATION


CIMT is favored over standard care for bimanual activity performance. Future research should investigate a longer follow-up period, additional comparator interventions, and analyse differences by participant characteristics.",2020,"CIMT was superior compared to control in terms of bimanual activity performance with a mean difference in AHA change score of 4.8 (SD=10.5, p=0.04, Cohen's δ=0.46).","['children with neonatal brachial plexus palsy (NBPP', 'children with neonatal brachial plexus palsy', 'Twenty-one children with NBPP (mean age 25mo, SD=10.3, range=17-48mo; 11 males, 10 females']","['constraint-induced movement therapy (CIMT', 'CIMT', 'Constraint-induced movement therapy']","['AHA change score', 'Pediatric Motor Activity Log-Revised (PMAL-R', 'bimanual activity performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2062712', 'cui_str': 'Obstetrical Brachial Plexus Lesion'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",21.0,0.0449162,"CIMT was superior compared to control in terms of bimanual activity performance with a mean difference in AHA change score of 4.8 (SD=10.5, p=0.04, Cohen's δ=0.46).","[{'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Werner', 'Affiliation': ""Institute for Nursing and Interprofessional Research, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Berggren', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Loiselle', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Gina Kim', 'Initials': 'GK', 'LastName': 'Lee', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}]",Developmental medicine and child neurology,['10.1111/dmcn.14741']
2680,33219852,The impact of three weeks of pre-quit varenicline on reinforcing value and craving for cigarettes in a laboratory choice procedure.,"RATIONALE


Varenicline, a partial nicotinic agonist, is theorized to attenuate pre-quit smoking reinforcement and post-quit withdrawal and craving. However, the mechanisms of action have not been fully characterized, as most studies employ only retrospective self-report measures, hypothetical indices of reinforcing value, and/or nontreatment-seeking samples.
OBJECTIVES


The current research examined the impact of pre-quit varenicline (vs. placebo) on laboratory measures of smoking and food (vs. water) reinforcement and craving.
METHODS


Participants were 162 treatment-seeking smokers enrolled in a randomized controlled trial of smoking cessation ( clinicaltrials.gov ID: NCT03262662). Participants completed two laboratory sessions: a pre-treatment session, ~ 1 week prior to beginning varenicline or placebo, and an active treatment session, after ~ 3 weeks of treatment. At each session, participants completed a laboratory choice procedure; on each of 36 trials, a lit cigarette, food item, or cup of water was randomly presented. Participants reported level of craving and spent $0.01-0.25 to have a corresponding 5-95% chance to sample the cue.
RESULTS


As predicted, spending was significantly higher on cigarette trials than water trials, and varenicline resulted in a greater between-session decline in spending on cigarette trials (but not water) than did placebo. Cigarette craving was enhanced in the presence of smoking cues compared to water, but neither average (tonic) cigarette craving nor cue-specific cigarette craving was significantly influenced by varenicline. Food spending and craving were generally unaffected by varenicline treatment.
CONCLUSIONS


These laboratory data from treatment-seeking smokers provide the strongest evidence to date that varenicline selectively attenuates smoking reinforcement prior to quitting.",2020,"Cigarette craving was enhanced in the presence of smoking cues compared to water, but neither average (tonic) cigarette craving nor cue-specific cigarette craving was significantly influenced by varenicline.",['Participants were 162 treatment-seeking smokers enrolled'],"['placebo', 'varenicline or placebo', 'pre-quit varenicline (vs. placebo', 'varenicline', 'pre-quit varenicline']","['laboratory measures of smoking and food (vs. water) reinforcement and craving', 'Cigarette craving', 'level of craving and spent', 'Food spending and craving', 'average (tonic) cigarette craving nor cue-specific cigarette craving']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",162.0,0.0662335,"Cigarette craving was enhanced in the presence of smoking cues compared to water, but neither average (tonic) cigarette craving nor cue-specific cigarette craving was significantly influenced by varenicline.","[{'ForeName': 'Schuyler C', 'Initials': 'SC', 'LastName': 'Lawson', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Gass', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Tonkin', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Colder', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Mahoney', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Tiffany', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Hawk', 'Affiliation': 'Department of Psychology, University at Buffalo (The State University of New York), Main Street, Buffalo, NY, 14214, USA. lhawk@buffalo.edu.'}]",Psychopharmacology,['10.1007/s00213-020-05713-7']
2681,33219876,Does the type of endodontic access influence in the cyclic fatigue resistance of reciprocating instruments?,"INTRODUCTION


The aim of the present study was to compare the cyclic fatigue resistance of Reciproc R25 (R25) and Reciproc Blue R25 (R25B) instruments, after simulated clinical use in traditional (TradAC) and ultraconservative (UltraAC) endodontic access cavities.
METHODS


Forty mandibular molars were randomly assigned into the following groups, according to the type of access and instrument to be used: TradAC and R25, TradAC and R25B, UltraAC and R25, and UltraAC and R25B. Teeth were accessed accordingly, and the root canals were prepared using ""RECIPROC ALL"" kinematics. The cyclic fatigue resistance of the forty used instruments was obtained measuring the time to fracture in an artificial stainless-steel canal. Ten brand new R25 and R25B were used as control groups. The fracture surfaces and the side cutting edges of the instruments were examined with a scanning electron microscope. Data were statistically analyzed using one-way ANOVA and post hoc Tukey tests with a significance level of P < 0.05.
RESULTS


R25B instruments showed significantly higher cyclic fatigue resistance than R25, regardless of the access cavity type (P < 0.05). No differences were observed in the cyclic fatigue resistance between instruments without simulated clinical use and used in TradAC (P > 0.05). R25 and R25B used in UltraAC showed significantly lower cyclic fatigue resistance compared with the instruments used in TradAC and without simulated clinical use (P < 0.05).
CONCLUSIONS


R25B files showed improved cyclic fatigue resistance than R25. The use of R25B and R25 files in mandibular molars with UltraACs decreased their cyclic fatigue resistance, compared with TradAC.
CLINICAL RELEVANCE


The use of Reciproc and Reciproc Blue files in mandibular molars with ultra-conservative endodontic access cavities reduced their cyclic fatigue resistance. Clinicians should be aware about the reduced cyclic fatigue resistance of these files when used in mandibular molars with UltraAC, due to the synergistic effect of access angulation and severe curvature induced in the endodontic files.",2020,"R25 and R25B used in UltraAC showed significantly lower cyclic fatigue resistance compared with the instruments used in TradAC and without simulated clinical use (P < 0.05).
","['mandibular molars with ultra-conservative endodontic access\xa0cavities reduced their cyclic fatigue resistance', 'Forty mandibular molars']","['TradAC and R25, TradAC and R25B, UltraAC and R25, and UltraAC and R25B', 'Reciproc and Reciproc Blue files', 'Reciproc R25 (R25) and Reciproc Blue R25 (R25B']",['cyclic fatigue resistance'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0016094', 'cui_str': 'Filing'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",40.0,0.0368467,"R25 and R25B used in UltraAC showed significantly lower cyclic fatigue resistance compared with the instruments used in TradAC and without simulated clinical use (P < 0.05).
","[{'ForeName': 'Emmanuel João Nogueira Leal', 'Initials': 'EJNL', 'LastName': 'Silva', 'Affiliation': 'Endodontics Department, Grande Rio University (UNIGRANRIO), Rua Herotides de Oliveira, 61/902, Icaraí, Niterói, Rio de Janeiro, 24220-000, Brazil. nogueiraemmanuel@hotmail.com.'}, {'ForeName': 'Rafael Santos', 'Initials': 'RS', 'LastName': 'Attademo', 'Affiliation': 'Endodontics Department, Grande Rio University (UNIGRANRIO), Rua Herotides de Oliveira, 61/902, Icaraí, Niterói, Rio de Janeiro, 24220-000, Brazil.'}, {'ForeName': 'Marcia Cristina Dutra', 'Initials': 'MCD', 'LastName': 'da Silva', 'Affiliation': 'Endodontics Department, Grande Rio University (UNIGRANRIO), Rua Herotides de Oliveira, 61/902, Icaraí, Niterói, Rio de Janeiro, 24220-000, Brazil.'}, {'ForeName': 'Karem Paula', 'Initials': 'KP', 'LastName': 'Pinto', 'Affiliation': 'Endodontics Department, Rio de Janeiro State University (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Henrique Dos Santos', 'Initials': 'HDS', 'LastName': 'Antunes', 'Affiliation': 'Endodontics Department, Grande Rio University (UNIGRANRIO), Rua Herotides de Oliveira, 61/902, Icaraí, Niterói, Rio de Janeiro, 24220-000, Brazil.'}, {'ForeName': 'Victor Talarico Leal', 'Initials': 'VTL', 'LastName': 'Vieira', 'Affiliation': 'Endodontics Department, Grande Rio University (UNIGRANRIO), Rua Herotides de Oliveira, 61/902, Icaraí, Niterói, Rio de Janeiro, 24220-000, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03694-7']
2682,33217836,A protocol of randomized controlled trial for Modified Xiaoyao Powder in the treatment of chronic obstructive pulmonary disease combined mild to moderate depression.,"INTRODUCTION


Depression is an important complication of chronic obstructive pulmonary disease (COPD), occurring in more than one-third of individuals with COPD, and its severity is closely related to the severity and acute exacerbation of COPD, significantly contributing to the risk of death from COPD. Comorbid depression in COPD can be a burden on COPD-related diseases by reducing quality of life and compliance with treatment. Unfortunately, symptoms of COPD combined anxiety and depression are not properly diagnosed and treated in clinical practice, especially in the early stages of mood changes in patients with COPD, as the symptoms are mild and monotonous, and are overlooked.
METHODS


In this prospective, randomized, placebo-controlled trial, we will assigned 280 eligible patients who had COPD combined depression to receive either Modified Xiaoyao Powder (MXP) or placebo. The primary end point is the change in the Hamilton Depression Scale (17 items) (HAMD-17) score from baseline on weeks 4, 12, and 24.
DISCUSSION


Six months of MXP for COPD combined mild to moderate depression may alleviate the symptoms of depression, reduce the frequency of hospitalizations, the number of exacerbations, and improve the compliance of treatment.
TRIAL REGISTRATION


ChiCTR2000038741.",2020,"combined mild to moderate depression may alleviate the symptoms of depression, reduce the frequency of hospitalizations, the number of exacerbations, and improve the compliance of treatment.
","['280 eligible patients who had COPD combined depression to receive either', 'chronic obstructive pulmonary disease combined mild to moderate depression']","['Modified Xiaoyao Powder', 'MXP for COPD', 'Modified Xiaoyao Powder (MXP) or placebo', 'placebo']",['Hamilton Depression Scale (17 items) (HAMD-17) score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1869284', 'cui_str': 'xiaoyao'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",280.0,0.182418,"combined mild to moderate depression may alleviate the symptoms of depression, reduce the frequency of hospitalizations, the number of exacerbations, and improve the compliance of treatment.
","[{'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, P.R. China.'}, {'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Wujun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023220']
2683,33217865,Laparoscopic anterior resection of rectum for rectal deeply infiltrating endometriosis: A short-term prospective randomized trial.,"Laparoscopic anterior resection of rectum (AR) is one of surgical approaches for deeply infiltrating endometriosis (DIE). Up to date, no clinical trials have clearly analyzed the short-term and long-term complications post-surgically, indications or feasibilities for surgical procedure, or post-operative recovery. The aims of this trial were to evaluate the indications for laparoscopic AR, the short-term and long-term complications post-surgically, post-operative recovery.We conducted a prospective study of 29 patients. They were divided into 2 groups. The period of follow-up was 12 months post-surgery. In our study, we recruited patents with laparoscopic AR experiencing failure of medical treatment (3 months) or associated infertility (>2cycles). The operative data and short term and long term complications were recorded. The outcomes of laparoscopic AR group were assessed by questionnaires, such as NRS (numeric rating scale), KESS (Knowles-Eccersley-Scott Symptom Questionnaire), VAS (visual analogue scale), WCS (Wexner constipation score) and ABS (Abdominal Bloating Score), which were compared with the outcomes of medicine group at set time points of baseline, 3 months, 6 months, 9 months and 12 months. The overall outcomes of the two groups were assessed with 5-point Likert Scale.Patients in surgery group were recovery rapidly without serious short term or long term complications. All of NRS, KESS, VAS, WCS, and ABS in surgery group were getting better greatly than that in medicine group (3.04 ± 1.91 vs 5.41 ± 3.01, 5.64 ± 1.54 vs 7.01 ± 1.03, 0.50 ± 0.38 vs 3.58 ± 2.01, 4.43 ± 1.02 vs 8.92 ± 2.45, and 0.61 ± 0.34 vs 1.42 ± 0.71) at 3 months post-operation. However, the advantage of surgery group was almost vanished at 12 months (4.02 ± 2.53 vs 5.99 ± 2.31, 7.42 ± 3.17 vs 10.98 ± 2.53, 1.59 ± 1.3 vs 2.23 ± 1.59, 6.01 ± 2.53 vs 7.90 ± 3.25, and 1.31 ± 1.05 vs 1.39 ± 1.02). Furthermore, we compared the overall outcomes between the 2 groups with 5-point Likert Scale, with confirmation of the advantage at 3 months post-surgically. Additionally, we compared these questionnaires, with the finding that VAS and 5-point Likert Scale of surgery group had the same changes. Finally, a table of indications for laparoscopic AR were tabulated according our clinical experience.Patients can receive benefit from both medicine and laparoscopic AR. However, laparoscopic AR has obvious advantage of rapid symptom relief. Further studies and clinical data collections are required for indications and feasibility of combined therapy.",2020,"All of NRS, KESS, VAS, WCS, and ABS in surgery group were getting better greatly than that in medicine group (3.04 ± ","['recruited patents with laparoscopic AR experiencing failure of medical treatment (3 months) or associated infertility (>2cycles', '29 patients', 'rectal deeply infiltrating endometriosis']","['laparoscopic AR', 'Laparoscopic anterior resection of rectum (AR', 'Laparoscopic anterior resection of rectum', 'medicine and laparoscopic AR']","['NRS (numeric rating scale), KESS (Knowles-Eccersley-Scott Symptom Questionnaire), VAS (visual analogue scale), WCS (Wexner constipation score) and ABS (Abdominal Bloating Score', '5-point Likert Scale', 'recovery rapidly without serious short term or long term complications', 'operative data and short term and long term complications']","[{'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0193083', 'cui_str': 'Anterior resection of rectum'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C4554317', 'cui_str': 'Deeply'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0193083', 'cui_str': 'Anterior resection of rectum'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220724', 'cui_str': 'Congenital constricting bands'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",29.0,0.048099,"All of NRS, KESS, VAS, WCS, and ABS in surgery group were getting better greatly than that in medicine group (3.04 ± ","[{'ForeName': 'Yong-Ping', 'Initials': 'YP', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, the Second Hospital of Jilin University.'}, {'ForeName': 'Ling-Yun', 'Initials': 'LY', 'LastName': 'Yu', 'Affiliation': 'Department of Ear Nose and Throat Surgery, the First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of General Surgery, the Second Hospital of Jilin University.'}, {'ForeName': 'Jian-Nan', 'Initials': 'JN', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, the Second Hospital of Jilin University.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, the Second Hospital of Jilin University.'}, {'ForeName': 'Tong-Jun', 'Initials': 'TJ', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, the Second Hospital of Jilin University.'}]",Medicine,['10.1097/MD.0000000000023309']
2684,33217877,To study the intervention mechanism of pediatric massage on intestinal flora and host metabolism in children with anorexia.,"BACKGROUND


As a common and frequent disease in pediatric patients, pediatric anorexia (PN) poses a serious threat to childhood growth and health. In recent years, societal changes in lifestyle and diet have increased the incidence of this PN, which has attracted extensive attention from both the medical community and parents. It has been shown that massage therapy represents an effective intervention for the treatment of anorexia, but investigation on its mechanism(s) of action remains limited. In this study, we will explore the biological mechanism(s) of PN from the perspective of intestinal flora, to further reveal its site of action and therapeutic mechanism(s).
METHODS


A total of 60 healthy children will be randomly selected for physical examination. According to a random number generated by a computer, children with anorexia who meet the inclusion criteria will be selected. In strict accordance with the time sequence of inclusion, subjects will be randomly assigned to either the massage or control group (n = 60 per group). The blank group will receive no treatment. Children in the massage group will receive a designated massage protocol. The control group will be administered oral Jianweixiaoshi tablets over 4 weeks. Each group will be compared for intestinal flora structure, fecal short chain fatty acids levels, serum trace elements, urine D-xylose-excretion rates, gastric fluid emptying, gastric motility, and hemoglobin levels before and after treatment.
RESULTS


We will review the clinical trial registry in China (http://www.chictr.org.cn/searchprojen.aspx), peer-reviewed journals and academic conferences.
CONCLUSION


This study will verify the intervention mechanism(s) of pediatric massage on intestinal flora and host metabolism in children with anorexia.
TRIAL REGISTRATION NUMBER


ChiCTR2000033274.",2020,"In strict accordance with the time sequence of inclusion, subjects will be randomly assigned to either the massage or control group (n = 60 per group).","['60 healthy children', 'children with anorexia who meet the inclusion criteria will be selected', 'pediatric patients, pediatric anorexia (PN', 'children with anorexia']","['pediatric massage', 'oral Jianweixiaoshi tablets']","['intestinal flora structure, fecal short chain fatty acids levels, serum trace elements, urine D-xylose-excretion rates, gastric fluid emptying, gastric motility, and hemoglobin levels']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0428595', 'cui_str': 'D-xylose, urine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0232572', 'cui_str': 'Gastric motility'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",60.0,0.0350278,"In strict accordance with the time sequence of inclusion, subjects will be randomly assigned to either the massage or control group (n = 60 per group).","[{'ForeName': 'Hanyuan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Xutong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Gansu Institute of Chinese Medicine.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Hanteng', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Lanzhou University Second Hospital, Lanzhou, Gansu, China.'}, {'ForeName': 'Shengcai', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000023349']
2685,33218112,Oxidative Stress in Endurance Cycling Is Reduced Dose-Dependently after One Month of Re-Esterified DHA Supplementation.,"Docosahexaenoic acid (DHA) supplementation can reduce exercise-induced oxidative stress generated during long aerobic exercise, with the minimum dose yet to be elucidated for physically active subjects. In this study, we performed a dose finding with re-esterified DHA in triglyceride form in a randomized double-blind parallel trial at different doses (350, 1050, 1750, and 2450 mg a day) for 4 weeks in males engaged in regular cycling ( n  = 100, 7.6 ± 3.7 h/week). The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention. To ascertain incorporation of DHA, erythrocyte polyunsaturated fatty acid (PUFA) composition was compared along groups. We found a dose-dependent antioxidant capacity of DHA from 1050 mg with a trend to neutralization for the highest dose of 2450 mg (placebo:  n  = 13, F = 0.041; 350 mg:  n  = 10, F = 0.268; 1050 mg:  n  = 11, F = 7.112; 1750 mg:  n  = 12, F = 9.681; 2450 mg:  n  = 10, F = 15.230). In the erythrocyte membrane, the re-esterified DHA increased DHA and omega-3 percentage and decreased omega 6 and the omega-6 to omega-3 ratio, while Eicosapentaenoic acid (EPA) and PUFA remained unchanged. Supplementation of re-esterified DHA exerts a dose-dependent endogenous antioxidant property against moderate-intensity long-duration aerobic exercise in physically active subjects when provided at least 1050 mg a day for 4 weeks.",2020,The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention.,"['physically active subjects', 'males engaged in regular cycling ( n  = 100, 7.6 ± 3.7 h/week']","['Docosahexaenoic acid (DHA) supplementation', 'placebo']","['DHA, erythrocyte polyunsaturated fatty acid (PUFA) composition', 'DHA and omega-3 percentage and decreased omega 6 and the omega-6 to omega-3 ratio, while Eicosapentaenoic acid (EPA) and PUFA', 'Oxidative Stress']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.235482,The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention.,"[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'de Salazar', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Torregrosa-García', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Luque-Rubia', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ávila-Gandía', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Domingo', 'Affiliation': 'Department of Biochemistry and Molecular Biomedicine, University of Barcelona, 08007 Barcelona, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9111145']
2686,33218253,Challenges in Obtaining and Assessing Salivary Cortisol and α-Amylase in an Over 60 Population Undergoing Psychotherapeutic Treatment for Complicated Grief: Lessons Learned.,"Biomarkers may serve as objective measures in complicated grief (CG) potentially capturing responses to stress reduction treatment. This paper reports challenges in obtaining and assessing salivary cortisol and α-amylase (sAA) for a recent randomized clinical trial. Within-session changes in salivary cortisol and sAA for 54 older adults with CG who received Accelerated Resolution Therapy were compared with perceived stress measured by Subjective Units of Distress Scale. Bivariate correlations and multiple regressions examined changes in biomarkers. Protocols, study logs, and audit reports identified challenges. Challenges included obtaining unstimulated passive drool salivary samples and their analyses. Our sample of older females on multiple medications may have resulted in a perfect storm of moderating and intervening variables which affected the stress response. This paper contributes to the discussion on designing clinical trials for older adults which must account for physiologic changes, multimorbidity, and polypharmacy common in this population and makes recommendations moving forward.",2020,Within-session changes in salivary cortisol and sAA for 54 older adults with CG who received Accelerated Resolution Therapy were compared with perceived stress measured by Subjective Units of Distress Scale.,"['60 Population Undergoing Psychotherapeutic Treatment for Complicated Grief', 'older adults', '54 older adults with CG']",[],"['Subjective Units of Distress Scale', 'salivary cortisol and sAA']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}]",54.0,0.0166209,Within-session changes in salivary cortisol and sAA for 54 older adults with CG who received Accelerated Resolution Therapy were compared with perceived stress measured by Subjective Units of Distress Scale.,"[{'ForeName': 'Jesse M', 'Initials': 'JM', 'LastName': 'Bell', 'Affiliation': 'College of Public Health, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tina M', 'Initials': 'TM', 'LastName': 'Mason', 'Affiliation': 'College of Nursing, University of South Florida, and Department of Nursing Research, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Harleah G', 'Initials': 'HG', 'LastName': 'Buck', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Cindy S', 'Initials': 'CS', 'LastName': 'Tofthagen', 'Affiliation': 'Division of Nursing Research, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Allyson R', 'Initials': 'AR', 'LastName': 'Duffy', 'Affiliation': 'College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Maureen W', 'Initials': 'MW', 'LastName': 'Groër', 'Affiliation': 'College of Nursing and Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McHale', 'Affiliation': 'Department of Psychology, USF St. Petersburg Family Study Center, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Kip', 'Affiliation': 'Health Services Division, Medical Center, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Clinical nursing research,['10.1177/1054773820973274']
2687,33218350,The effect of letrozole versus artificial hormonal endometrial preparation on pregnancy outcome after frozen-thawed embryos transfer cycles: a randomized clinical trial.,"BACKGROUND


Considering that clinical trial studies are limited in polycystic ovary syndrome (PCOS) patients, and there is no consensus on an optimum endometrial preparation protocol for frozen embryo transfer (FET), the present study was designed as a randomized clinical trial to compare the reproductive outcomes following stimulated cycles with letrozole plus human menopausal gonadotropin (HMG) for endometrial preparation compared with routine AC-FET.
METHODS


This randomized controlled trial was carried out on infertile PCOS patients who underwent IVF/ICSI and FET cycles in Arash Women's Hospital affiliated to Tehran University of Medical Sciences between September 2018 and January 2020. PCOS diagnosis was based on the Rotterdam criteria. Eligible patients were randomly allocated into two groups: stimulated cycle with letrozole plus (HMG) (intervention group) and routine artificial hormonal endometrial preparation (control group).
RESULTS


One hundred seventy-seven infertile patients were recruited for participation in the study. Of these, 57 women were excluded due to non-eligibility for entering the study, and a total of 120 patients were randomly assigned to two study groups. After follow up, the cycle outcomes of 57 patients in the intervention group and 59 patients in the control group were compared. The data analysis showed that the two groups did not have significant differences in fundamental and demographic characteristics. After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups. Moreover, the rates of miscarriage and ongoing pregnancy were similar between groups (P > 0.05).
CONCLUSIONS


We found similar pregnancy outcomes with two endometrial preparation methods. Noting that each treatment centre should select the most beneficial and cost-effective method with the least adverse effects for patients, letrozole preparations for FET could be incorporated into possible options; however, establishing this approach as first-line treatment is premature in light of current evidence, and future randomized clinical trials with larger sample sizes are required for widespread application.
TRIAL REGISTRATION


The study was also registered in the Iranian Registry of Clinical Trials on March 20th, 2020. ( IRCT20090526001952N12 at www.irct.ir , registered retrospectively).",2020,"After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups.","[""infertile PCOS patients who underwent IVF/ICSI and FET cycles in Arash Women's Hospital affiliated to Tehran University of Medical Sciences between September 2018 and January 2020"", 'after frozen-thawed embryos transfer cycles', 'Eligible patients', 'One hundred seventy-seven infertile patients were recruited for participation in the study', '57 women were excluded due to non-eligibility for entering the study, and a total of 120 patients', 'polycystic ovary syndrome (PCOS) patients']","['letrozole', 'artificial hormonal endometrial preparation', 'letrozole plus human menopausal gonadotropin (HMG', 'letrozole plus (HMG) (intervention group) and routine artificial hormonal endometrial preparation (control group']","['implantation rate, chemical, ectopic, and clinical pregnancy rates', 'PCOS diagnosis', 'pregnancy outcome', 'rates of miscarriage and ongoing pregnancy']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",120.0,0.157576,"After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups.","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Hosseini-Najarkolaei', 'Affiliation': ""Department of Gynecology and Obstetrics, Arash women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': ""Department of Gynecology and Obstetrics, Arash women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. a_moini@royaninstitute.org.""}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': ""Department of Gynecology and Obstetrics, Arash women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farid Mojtahedi', 'Affiliation': ""Department of Gynecology and Obstetrics, Arash women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Hosseini-Najarkolaee', 'Affiliation': 'Laparoscopic Research Centre, Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ensieh', 'Initials': 'E', 'LastName': 'Salehi', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-020-00675-z']
2688,33218372,Bilateral Differences in Dancers' Dynamic Postural Stability During Jump Landings.,"Although traditional dance training aims to train dancers' legs equally, the recognized practice of predominately starting and repeating exercises on one side more than the other has led to suggestions that technique classes may cause lateral bias. Such an imbalance could lead to a greater risk of injury; however, despite this potential risk, little is known about the effects of bilateral differences on dancers' postural stability during jump landings, a key dynamic action in dance. Therefore, the aim of this study was to examine the effects of possible bilateral differences on dynamic postural stability during single-leg landing using a time-to-stabilization protocol. Thirty-two injury-free female university undergraduate dancers (19 ± 1.9 years; 164.8 ± 6.7 cm; 62.6 ± 13.6 kg) volunteered for the study. They completed a two-foot to one-foot jump over a bar onto a force platform while stabilizing as quickly as possible. The landing leg was randomly assigned, and participants completed three trials for each leg. No significant differences in dynamic postural stability between right and left legs were revealed, and poor effect size was noted (p > 0.05): MLSI: t = -.04, df = 190, p = 0.940 (CI = -.04, .04, r² = 0); APSI: t = .65, df = 190, p = 0.519 (CI = -.06-, .12, r² = .09); VSI: t = 1.85, df = 190, p = 0.066 (CI = -.02, .68, r² = .27); DPSI: t = 1.88, df = 190, p = 0.061 (CI = -.02, .70, r² = .27). The results of this study do not support the notion that dance training may cause lateral bias with its associated risk of injury. Furthermore, dancers' self-perceptions of leg dominance did not correlate with their ability to balance in single-leg landings or to absorb the ground reaction forces often associated with injury. Even when biased training exists, it may not have detrimental effects on the dancer's postural stability.",2020,"No significant differences in dynamic postural stability between right and left legs were revealed, and poor effect size was noted (p > 0.05):","['Thirty-two injury-free female university undergraduate dancers (19 ± 1.9 years; 164.8 ± 6.7 cm', '62.6 ± 13.6 kg) volunteered for the study']",['MLSI'],"['dynamic postural stability between right and left legs', 'dynamic postural stability']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0876288,"No significant differences in dynamic postural stability between right and left legs were revealed, and poor effect size was noted (p > 0.05):","[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Clarke', 'Affiliation': 'National Institute of Dance Medicine and Science, and Trinity Laban Conservatoire of Music & Dance, London, United Kingdom;, Email: f.clarke@trinitylaban.ac.uk.'}, {'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Koutedakis', 'Affiliation': 'Department of Sport and Exercise Sciences, University of Thessaly, Trikala, Greece; and Sport and Physical Activity Research Centre and School of Performing Arts, University of Wolverhampton, Walsall, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': 'Department of Theatre and Dance, University of Wyoming, Laramie, Wyoming, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wyon', 'Affiliation': 'National Institute of Dance Medicine and Science, United Kingdom, and Sport and Physical Activity Research Centre and School of Performing Arts, University of Wolverhampton, Walsall, United Kingdom.'}]",Journal of dance medicine & science : official publication of the International Association for Dance Medicine & Science,['10.12678/1089-313X.24.4.183']
2689,33218376,Patient Comfort During Cataract Surgery: A Comparison of Troche and Intravenous Sedation.,"Advancements in ophthalmologic procedures warrant exploration of alternative approaches to standard intravenous (IV) anesthesia sedation. One new approach, a sublingual troche containing midazolam, ketamine, and ondansetron, allows for IV catheter-free administration of sedation. This project compared the effectiveness and equivalency of sublingual troche during monitored anesthesia sedation with traditional IV sedation for maintaining comfort in patients undergoing cataract surgery. The study was conducted at a surgery center using an after-only nonequivalent control group design. Patients (N=107) were 55 to 85 years of age; 54 patients received IV sedation, and 53 received troche sedation. Four patients receiving IV sedation reported nausea during and after the procedure (n=1, 1.9%) or pain during the procedure (n=3, 5.6%), whereas 3 patients receiving troche sedation reported dizziness after the procedure (n=1, 1.9%), and pain during the procedure (n=2, 3.8%). Although the troche group (mean=6.25, SD=3.94) spent less time in recovery than the IV group (mean=6.48, SD=2.61), the difference was not significant (t[df=105]=0.677, P>.05). In conclusion, the results showed comparable experiences for both groups with equivalency and effectiveness in providing patient comfort during cataract surgery.",2020,"Although the troche group (mean=6.25, SD=3.94) spent less time in recovery than the IV group (mean=6.48, SD=2.61), the difference was not significant (t[df=105]=0.677, P>.05).","['patients undergoing cataract surgery', 'Patients (N=107) were 55 to 85 years of age; 54 patients received']","['midazolam, ketamine, and ondansetron', 'traditional IV sedation', 'Troche and Intravenous Sedation', 'IV sedation, and 53 received troche sedation', 'standard intravenous (IV) anesthesia sedation']","['dizziness', 'nausea', 'Patient Comfort', 'spent less time in recovery', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",107.0,0.0262067,"Although the troche group (mean=6.25, SD=3.94) spent less time in recovery than the IV group (mean=6.48, SD=2.61), the difference was not significant (t[df=105]=0.677, P>.05).","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Smith', 'Affiliation': 'is a faculty member, Nurse Anesthesia Program, College of Applied Studies, Florida State University, Panama City, Florida, and a practicing CRNA, Jackson Anesthesia Associates, Marianna, Florida.'}, {'ForeName': 'Bernita K', 'Initials': 'BK', 'LastName': 'Hamilton', 'Affiliation': 'is a professor, School of Nursing, Troy University, Troy, Alabama.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'VanDyke', 'Affiliation': 'is program administrator, Nurse Anesthesia Program, College of Applied Studies, Florida State University, Panama City.'}]",AANA journal,[]
2690,33218384,Comparative Evaluation of Tube First Versus Video Laryngoscope First Techniques in a Normal and Simulated Difficult Airway Model: A Randomized Controlled Trial.,"In patients with difficult airways, there can be difficulty with advancing the endotracheal tube into the airway even with a good view of the glottis using video laryngoscopy. The purpose of this study was to determine if the time required to intubate an airway and the number of gaze changes by the laryngoscopist could be decreased by using a novel video laryngoscope technique. Sixteen experienced Certified Registered Nurse Anesthetists were recruited to intubate a manikin with a normal or difficult airway using both the laryngoscope first technique and a new endotracheal tube first technique (4 intubations total) in a randomized sequence. The data were analyzed with the Mann-Whitney (U) test to compare the differences between the normal and difficult airway conditions. Although no significant difference was noted in the time to intubation between intubation techniques, the number of gaze changes was found to be significantly fewer in the tube first technique (P=.0009). A steep learning curve, associated with the accommodation of the manikin, was demonstrated by a decrease in time and gaze changes with subsequent intubations. Incorporating the endotracheal tube first technique into an education curriculum could increase patient safety by decreasing the time to secure a difficult airway.",2020,"Although no significant difference was noted in the time to intubation between intubation techniques, the number of gaze changes was found to be significantly fewer in the tube first technique (P=.0009).","['a Normal and Simulated Difficult Airway Model', 'Sixteen experienced Certified Registered Nurse Anesthetists']",['Tube First Versus Video Laryngoscope First Techniques'],"['patient safety', 'time to intubation', 'number of gaze changes', 'time and gaze changes']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",16.0,0.0161196,"Although no significant difference was noted in the time to intubation between intubation techniques, the number of gaze changes was found to be significantly fewer in the tube first technique (P=.0009).","[{'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Lee', 'Affiliation': ""is a CRNA manager at Monroe Carrell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center, Nashville, Tennessee. Email: Walter.t.lee@vumc.org.""}, {'ForeName': 'Ryan W', 'Initials': 'RW', 'LastName': 'Hill', 'Affiliation': 'is a staff CRNA at Vanderbilt University Medical Center.'}, {'ForeName': 'Joydeep', 'Initials': 'J', 'LastName': 'Baidya', 'Affiliation': 'is a senior undergraduate student at Cornell University in Ithaca, New York.'}, {'ForeName': 'Dinesh K', 'Initials': 'DK', 'LastName': 'Choudhry', 'Affiliation': 'is a pediatric anesthesiologist and director of research in the Department of Anesthesiology at Nemours/Alfred I. DuPont Hospital for Children, Wilmington, Delaware, and a clinical professor of anesthesiology at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'B Randall', 'Initials': 'BR', 'LastName': 'Brenn', 'Affiliation': ""is a pediatric anesthesiologist and associate professor of anesthesiology, medical director of perioperative informatics, and director of pediatric clinical informatics at Monroe Carrell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center.""}]",AANA journal,[]
2691,33218511,The effect of core stability training with ball and balloon exercise on respiratory variables in chronic non-specific low back pain: An experimental study.,"BACKGROUND


Studies have shown the involvement of respiratory characteristics and their relationship with impairments in non-specific low back pain (NS-LBP). The effects of core stability with a combined ball and balloon exercise (CBB) on respiratory variables had not been investigated.
OBJECTIVE


To evaluate the effectiveness of CBB on respiratory variables among NS-LBP patients.
STUDY DESIGN


pre- and post-experimental study.
PARTICIPANTS


Forty participants were assigned to an experimental group (EG) [n = 20] and control group (CG) [n = 20] based on the study criteria.
INTERVENTIONS


The EG received CBB together with routine physiotherapy and the CG received routine physiotherapy over a period of 8 weeks. Participants were instructed to carry out the exercises for 3 days per week. The training was evaluated once a week and the exercises progressed based on the level of pain.
OUTCOME MEASURES


Primary outcomes were maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) and maximum voluntary ventilation (MVV). The secondary outcomes were measured in the numeric rating scale (NRS), total faulty breathing scale (TFBS), cloth tape measure (CTM) and lumbo-pelvic stability.
RESULTS


The MIP increased significantly among the EG when compared with that in the CG (p > 0.05).The EG showed a significant increase in MVV (p = 0.04) when compared to the CG (p = 0.0001). There was a significant reduction in pain for both groups. The MEP, TFBS, chest expansion and core stability showed no changes in either group.
CONCLUSION


CBB was effective in improving respiratory variables among NS-LBP patients.",2020,EG showed a significant increase in MVV (p = 0.04) when compared to the CG (p = 0.0001).,"['chronic non-specific low back pain', 'Forty participants', 'NS-LBP patients']","['core stability training with ball and balloon exercise', 'CBB', 'experimental group (EG) [n\xa0=\xa020] and control group (CG) [n\xa0=\xa020', 'combined ball and balloon exercise (CBB']","['MVV', 'MEP, TFBS, chest expansion and core stability', 'respiratory variables', 'maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) and maximum voluntary ventilation (MVV', 'numeric rating scale (NRS), total faulty breathing scale (TFBS), cloth tape measure (CTM) and lumbo-pelvic stability', 'MIP', 'pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280014', 'cui_str': 'Faulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.0397768,EG showed a significant increase in MVV (p = 0.04) when compared to the CG (p = 0.0001).,"[{'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': 'Centre of Physiotherapy, Faculty of Health Sciences, Universiti Teknologi MARA, Puncak Alam, 42300, Malaysia; Neuro-Musculoskeletal and Pain Research Unit, Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, 50200, Thailand.'}, {'ForeName': 'Aatit', 'Initials': 'A', 'LastName': 'Paungmali', 'Affiliation': 'Neuro-Musculoskeletal and Pain Research Unit, Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, 50200, Thailand. Electronic address: aatit.p@cmu.ac.th.'}, {'ForeName': 'Patraporn', 'Initials': 'P', 'LastName': 'Sitilertpisan', 'Affiliation': 'Neuro-Musculoskeletal and Pain Research Unit, Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, 50200, Thailand. Electronic address: patraporn.s@cmu.ac.th.'}, {'ForeName': 'Leonard Joseph', 'Initials': 'LJ', 'LastName': 'Henry', 'Affiliation': 'School of Health Science, University of Brighton, Eastbourne, BN20 7UR, East Sussex, United Kingdom.'}, {'ForeName': 'Fathien Aquilla', 'Initials': 'FA', 'LastName': 'Omar', 'Affiliation': 'Centre of Physiotherapy, Faculty of Health Sciences, Universiti Teknologi MARA, Puncak Alam, 42300, Malaysia.'}, {'ForeName': 'Fatin Zulaikha', 'Initials': 'FZ', 'LastName': 'Azhar', 'Affiliation': 'Centre of Physiotherapy, Faculty of Health Sciences, Universiti Teknologi MARA, Puncak Alam, 42300, Malaysia.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.007']
2692,33218513,Replacing canes with an elasticated orthotic-garment in chronic stroke patients - The influence on gait and balance. A series of N-of-1 trials.,"OBJECTIVE


To investigate the effect of replacing canes with an elasticated orthotic-garment on balance and gait-function in chronic stroke survivors.
DESIGN


Experimental, N-of-1 series with a replicated, ABC design with randomised phase duration in a home setting.
PARTICIPANTS


Four cane using chronic stroke survivors (P1-4).
INTERVENTIONS


Phase A (9-12 weeks) cane-walking ""as usual"" to establish baseline values; Phase B (9-16 weeks) intervention: orthotic-garment worn throughout the day with maximal cane-use reduction; Phase C (9-10 weeks) participant-determined follow-up: either no walking-aid, orthotic-garment or cane.
OUTCOME MEASURES


Primary: Functional-Gait-Assessment (FGA), Secondary: Trunk-sway during walking measured as Total-Angle-Area (TAA° 2 ) in frontal and sagittal-planes, both measured weekly.
RESULTS


Visual and statistical analysis of results showed significant improvements in FGA from phase A to B in all participants. Improvement continued in phase C in P2, stabilized in P1 and P4 and deteriorated in P3. A Minimal-Clinical-Important-Difference of 6 points-change was achieved in P2 & P4. Trunk-sway reduced during walking, indicating increased stability, in two participants from phase A to B and in three participants from A to C but no TAA changes were statistically significant. In phase C participant-selected walking-aids were: P1 cane-usage reduced by 25%, P2 independent-walking with no assistive-device, S3 usual cane-usage, P4 orthotic-garment with reduced cane-usage 2-3 days-a-week, usual cane-usage 4-5 days.
CONCLUSIONS


Although walking ability is multifactorial these results indicate that the choice of walking-aids can have a specific and clinically relevant impact on gait following stroke. ""Hands-free"" assistive-devices may be more effective than canes in improving gait-function in some patients. CLINICALTRIALS.
GOV ID


NCT03642444.",2020,"Trunk-sway reduced during walking, indicating increased stability, in two participants from phase A to B and in three participants from A to C but no TAA changes were statistically significant.","['chronic stroke survivors', 'Four cane using chronic stroke survivors (P1-4', 'chronic stroke patients ']","['replacing canes with an elasticated orthotic-garment', 'no walking-aid, orthotic-garment or cane', 'elasticated orthotic-garment', 'intervention: orthotic-garment worn throughout the day with maximal cane-use reduction; Phase C (9-10 weeks', 'P1 cane-usage reduced by 25%, P2 independent-walking with no assistive-device, S3 usual cane-usage, P4 orthotic-garment with reduced cane-usage 2-3 days-a-week, usual cane-usage 4-5 days', 'Primary: Functional-Gait-Assessment (FGA), Secondary']","['Trunk-sway during walking measured as Total-Angle-Area (TAA° 2 ) in frontal and sagittal-planes', 'gait-function', 'gait and balance', 'Trunk-sway reduced during walking, indicating increased stability', 'FGA']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0204009', 'cui_str': 'Use of cane education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0006856', 'cui_str': 'Cane'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0557834', 'cui_str': 'Walking aid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0204009', 'cui_str': 'Use of cane education'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003486', 'cui_str': 'Aortic aneurysm'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",2.0,0.0410862,"Trunk-sway reduced during walking, indicating increased stability, in two participants from phase A to B and in three participants from A to C but no TAA changes were statistically significant.","[{'ForeName': 'Clare C', 'Initials': 'CC', 'LastName': 'Maguire', 'Affiliation': 'Department of Physiotherapy, Bildungszentrum Gesundheit Basel-Stadt, 4142, Muenchenstein, Switzerland; Caphri School for Public Health and Primary Care Research, Maastricht University, 6200, MD, Maastricht, the Netherlands; Department of Physiotherapy, REHAB, Clinic for Neurorehabilitation and Paraplegiology, Basel, Switzerland; Department of Health, Bern University of Applied Science, Schwarztorstrasse 48, 3007, Bern, Switzerland. Electronic address: clare.maguire@bfh.ch.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Sieben', 'Affiliation': 'Caphri School for Public Health and Primary Care Research, Maastricht University, 6200, MD, Maastricht, the Netherlands; Department of Anatomy and Embryology, Maastricht University, 6200, MD, Maastricht, the Netherlands.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Lutz', 'Affiliation': 'Department of Physiotherapy, Bildungszentrum Gesundheit Basel-Stadt, 4142, Muenchenstein, Switzerland.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'van der Wijden', 'Affiliation': 'Department of Physiotherapy, REHAB, Clinic for Neurorehabilitation and Paraplegiology, Basel, Switzerland.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Scheidhauer', 'Affiliation': 'Department of Physiotherapy, Bildungszentrum Gesundheit Basel-Stadt, 4142, Muenchenstein, Switzerland.'}, {'ForeName': 'RobertA', 'Initials': 'R', 'LastName': 'de Bie', 'Affiliation': 'Caphri School for Public Health and Primary Care Research, Maastricht University, 6200, MD, Maastricht, the Netherlands; Department of Epidemiology, Maastricht University, 6200, MD, Maastricht, the Netherlands.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.006']
2693,33218514,Cranial osteopathic treatment and stress-related effects on autonomic nervous system measured by salivary markers: A pilot study.,"BACKGROUND


Variations in the concentration of salivary alpha amylase (sAA) may indicate a change in the autonomic nervous system functionality. In osteopathic medicine it has long been stated that the osteopathic manipulative treatment (OMT) can modulate the autonomic nervous system. Studies carried out on the compression of the fourth ventricle (CV4) have shown a positive effect in reducing the sympathetic tone. The goal of this pilot study is measuring the physiological response of the sAA levels after CV4 technique.
METHODS


90 subjects were randomly assigned to a sham, a control or a CV4 group. Randomization accounted for sex and score in the STAI-2 (form Y) questionnaire. Each subject completed the STAI-1 (form Y) questionnaire to evaluate the anxiety of the moment. sAA activity and saliva flow rate were measured. Saliva was collected before, immediately after and 30 min after treatment.
RESULTS


Within group analysis revealed that sAA activity increased significantly immediately after the technique application only in the CV4 group (p = 0,05). Between groups analysis show a significant difference of the sAA activity in the CV4 group respect the control group (p < 0,05), but no significant difference between CV4 and sham group (p > 0,05). The effect in the CV4 group after the intervention is highly variable and appeared to be related to the level of stress measured with the STAI-Y1 questionnaire (p = 0,002).
CONCLUSIONS


This study shows a positive effect of the CV4 procedure on sAA activity even if not significantly different from the sham procedure, probably due to the confounding effect of stress variability between groups.",2020,"This study shows a positive effect of the CV4 procedure on sAA activity even if not significantly different from the sham procedure, probably due to the confounding effect of stress variability between groups.","['90 subjects', 'salivary markers']",['CV4 procedure'],"['sAA activity', 'sAA activity and saliva flow rate', 'sympathetic tone']","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0450813', 'cui_str': 'CV4'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}]",90.0,0.0408558,"This study shows a positive effect of the CV4 procedure on sAA activity even if not significantly different from the sham procedure, probably due to the confounding effect of stress variability between groups.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abenavoli', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy. Electronic address: alessandra.abenavoli@aimoedu.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Badi', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bianchi', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Biglione', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dealessi', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grandini', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lavazza', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mapelli', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Milano', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Monti', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Seppia', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tresoldi', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maggiani', 'Affiliation': 'AIMO Accademia Italiana di Medicina Osteopatica, Piazzale del Santuario 7, 21047, Saronno, (VA), Italy.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.017']
2694,33218516,Whole body vibration in the static modified push-up position in untrained healthy women stimulates neuromuscular system potentiating increased handgrip myogenic response.,"OBJECTIVE


To investigate the acute effect of whole-body vibration (WBV) on handgrip strength (HS) and electromyographic activity of the flexor digitorum superficialis muscle of healthy women in the static push-up position.
METHODS


Twenty-eight women received four experimental tests in a randomized order: A) Control - rest in seating position with feet on the floor and hands in the supine position on the lower limbs. There was no vibration stimulus; B) Placebo - push-up position with their hands on the vibratory platform that remained disconnected, but with a sonorous stimulus mimicking the vibration; C) Low vibration and D) High vibration - push-up position with their hands on the vibratory platform using one of the vibratory stimulus intensity: low vibration: 25 Hz/2 mm/49.30 m s -2 ; or high vibration: 45 Hz/2 mm/159.73 m s -2 . Participants remained 5 min in each situation. HS and electromyography (EMG) were performed at baseline and after all four experimental tests. The index of neural efficiency (i.e. the ratio between EMG and HS) was also calculated to determine the efficiency of muscle contraction. Statistical analysis was performed by ANOVA two-way design mixed test with Tukey's post hoc test, being considered significant p < 0.05.
RESULTS


High vibration increased HS compared with all the other experimental tests (p = 0.0006, F = 6.03). There was a reduction of EMG activity of the flexor digitorum superficialis muscle only after high vibration (p = 0.0135, F = 6.22), which was accompanied by lower values of the index of neural efficiency after intervention (between-group difference, p = 0.0002, F = 0.674).
CONCLUSION


WBV in the push-up position has an acute positive effect on HS accompanied by a lower index of neural efficiency, providing a better efficiency of muscle contraction.",2020,"RESULTS


High vibration increased HS compared with all the other experimental tests (p = 0.0006, F = 6.03).","['untrained healthy women', 'healthy women in the static push-up position', 'Twenty-eight women received four experimental tests in a randomized order']","['Placebo', 'High vibration - push-up position with their hands on the vibratory platform using one of the vibratory stimulus intensity: low vibration: 25\xa0Hz/2 mm/49.30\xa0m\xa0s -2 ; or high vibration: 45\xa0Hz/2 mm/159.73\xa0m', 'whole-body vibration (WBV']","['High vibration increased HS', 'HS and electromyography (EMG', 'EMG activity of the flexor digitorum superficialis muscle', 'handgrip strength (HS) and electromyographic activity', 'handgrip myogenic response', 'index of neural efficiency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2722359', 'cui_str': 'S-2'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",28.0,0.0153855,"RESULTS


High vibration increased HS compared with all the other experimental tests (p = 0.0006, F = 6.03).","[{'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'Cristino de Souza', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa Amaral', 'Initials': 'VA', 'LastName': 'Mendonça', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Multicenter Postgraduate Program in Physiological Sciences (PMPGCF), Brazilian Society of Physiology (SBFis), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Coelho de Oliveira', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Sueli', 'Initials': 'S', 'LastName': 'Ferreira da Fonseca', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Multicenter Postgraduate Program in Physiological Sciences (PMPGCF), Brazilian Society of Physiology (SBFis), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Luciana Martins', 'Initials': 'LM', 'LastName': 'Mello Santos', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'José Sebastião', 'Initials': 'JS', 'LastName': 'Cunha Fernandes', 'Affiliation': 'Faculty of Agrarian Sciences, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Hércules Ribeiro', 'Initials': 'HR', 'LastName': 'Leite', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Multicenter Postgraduate Program in Physiological Sciences (PMPGCF), Brazilian Society of Physiology (SBFis), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation Sciences, School of Physical Education, Physical Therapy and Occupational Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Luiz de Mendonça Martins', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Jousielle', 'Initials': 'J', 'LastName': 'Márcia Dos Santos', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Multicenter Postgraduate Program in Physiological Sciences (PMPGCF), Brazilian Society of Physiology (SBFis), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Angélica', 'Initials': 'A', 'LastName': 'de Fátima Silva', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Bruno Alvarenga', 'Initials': 'BA', 'LastName': 'Soares', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation Sciences, School of Physical Education, Physical Therapy and Occupational Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa Gonçalves', 'Initials': 'VG', 'LastName': 'César Ribeiro', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Multicenter Postgraduate Program in Physiological Sciences (PMPGCF), Brazilian Society of Physiology (SBFis), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Pedro Henrique', 'Initials': 'PH', 'LastName': 'Scheidt Figueiredo', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Vinicius Cunha', 'Initials': 'VC', 'LastName': 'Oliveira', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Bernardo-Filho', 'Affiliation': 'Department of Biophysics and Biometrics, Institute of Biology Roberto Alcantara Gomes, State University of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sartorio', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Division of Auxology and Metabolic Diseases, Verbania, Italy.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Rodrigues Lacerda', 'Affiliation': 'Integrated Center of Research and Postgraduation in Health (CIPq), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Faculty of Biological Sciences and Health, Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Postgraduate Program in Rehabilitation and Functional Performance (PPGReab), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil; Multicenter Postgraduate Program in Physiological Sciences (PMPGCF), Brazilian Society of Physiology (SBFis), Federal University of the Jequitinhonha and Mucuri Valleys (UFVJM), Diamantina, Minas Gerais, Brazil. Electronic address: lacerda.acr@ufvjm.edu.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.021']
2695,33217600,Application of thrombin gel matrix for the prevention of lymphocele in patients with endometrial cancer: A prospective randomized trial.,"OBJECTIVE


To evaluate a thrombin gel matrix (TGM), Floseal, for the prevention of lymphocele in patients with endometrial cancer who underwent pelvic lymphadenectomy.
METHODS


A total of 79 consecutive patients with endometrial cancer were randomly allocated to one of two groups: the TGM group and control group. After completion of the lymphadenectomy, 5 mL of Floseal was applied to the bilateral pelvic sidewalls, especially the femoral canal, obturator, and common iliac vessels areas. Computed tomography scans were obtained for lymphocele evaluation 2 months after the surgery.
RESULTS


Three patients from the TGM group, and four patients from the control group were lost during follow-up, and data from 36 participants from each group were analyzed. As the primary outcome, lymphocele developed in 12 patients in both groups (33%). There was no significant difference between the groups in terms of lymphocele and symptomatic lymphocele development. Lymphocele localization was also not different between the two groups, but the diameter of the lymphoceles detected in the TGM group was significantly greater (p = 0.021). The mean drainage days was significantly shorter in the TGM group (p = 0.015). The amount of drainage was also less in the TGM group, but the difference was not statistically significant.
CONCLUSION


Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer. However, it can reduce the amount of drainage and the number of drainage days so it can help to shorten hospitalization.",2020,"CONCLUSION


Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer.","['patients with endometrial cancer who underwent pelvic lymphadenectomy', '79 consecutive patients with endometrial cancer', 'patients with endometrial cancer']","['TGM group and control group', 'thrombin gel matrix', 'Thrombin gel matrix', 'TGM', 'thrombin gel matrix (TGM), Floseal', 'lymphadenectomy, 5\u2009mL of Floseal']","['mean drainage days', 'Lymphocele localization', 'incidence of symptomatic or asymptomatic lymphoceles', 'amount of drainage', 'lymphocele and symptomatic lymphocele development', 'lymphocele']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",79.0,0.0301364,"CONCLUSION


Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer.","[{'ForeName': 'Şener', 'Initials': 'Ş', 'LastName': 'Gezer', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey. Electronic address: dr.senergezer@gmail.com.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Pulur', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Yücesoy', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101994']
2696,33217618,End of Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To report the end of study results from the Ladder clinical trial of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
DESIGN


Multicenter, randomized, active treatment-controlled phase 2 clinical trial.
PARTICIPANTS


Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220).
METHODS


Patients were randomized 3:3:3:2 to treatment with the PDS filled with ranibizumab 10 mg/mL, 40 mg/mL, and 100 mg/mL formulations or monthly intravitreal ranibizumab 0.5 mg injections.
MAIN OUTCOME MEASURES


End of study results for the time to first meeting refill criteria (first refill), mean change from baseline for best-corrected visual acuity (BCVA) and central foveal thickness (CFT), and safety.
RESULTS


At study end, the mean (range) time on study was 22.1 (10.8-37.6) months for all PDS patients. Median time to first refill was 8.7, 13.0, and 15.8 months, and 28.9%, 56.0%, and 59.4% of patients went 12 months or longer without meeting refill criteria in the PDS 10 mg/mL, 40 mg/mL, and 100 mg/mL treatment arms, respectively. At month 22, the observed mean BCVA change from baseline was ‒4.6, ‒2.3, +2.9, and +2.7 Early Treatment Diabetic Retinopathy Study letters in the PDS 10 mg/mL, 40 mg/mL, 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg treatment arms, respectively. At month 22, the observed mean CFT change from baseline was similar in the PDS 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg treatment arms. No new safety signals were detected during the additional follow-up.
CONCLUSIONS


Over a mean of 22 months on study, vision and anatomic outcomes were comparable between the PDS 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg arms, with a lower total number of ranibizumab treatments with the PDS. The Ladder end of study findings were consistent with the primary analysis, and the PDS was generally well tolerated throughout the entire study period. The PDS has the potential to reduce treatment burden in patients with nAMD while maintaining vision.",2020,"No new safety signals were detected during the additional follow-up.
","['neovascular age-related macular degeneration (nAMD', 'Patients', 'patients with nAMD while maintaining vision', 'Neovascular Age-Related Macular Degeneration', 'Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220']","['Ranibizumab', 'ranibizumab (PDS', 'PDS filled with ranibizumab 10 mg/mL, 40 mg/mL, and 100 mg/mL formulations or monthly intravitreal ranibizumab 0.5 mg injections', 'ranibizumab']","['time to first meeting refill criteria (first refill), mean change from baseline for best-corrected visual acuity (BCVA) and central foveal thickness (CFT), and safety', 'new safety signals', 'vision and anatomic outcomes', 'mean CFT change', 'Median time to first refill', 'observed mean BCVA change']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C1724107', 'cui_str': 'ranibizumab 10 MG/ML'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",220.0,0.131031,"No new safety signals were detected during the additional follow-up.
","[{'ForeName': 'Arshad M', 'Initials': 'AM', 'LastName': 'Khanani', 'Affiliation': 'Sierra Eye Associates, Reno, Nevada, and the University of Nevada, Reno School of Medicine, Reno, Nevada. Electronic address: arshad.khanani@gmail.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': 'Texas Retina Associates, Arlington, Texas.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Dreyer', 'Affiliation': 'Retina Northwest, Portland, Oregon, and Baylor University, Waco, Texas.'}, {'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Orange County Retina, Santa Ana, California.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Howard', 'Affiliation': 'Retina Associates of Utah, Salt Lake City, Utah, and Department of Ophthalmology and Visual Sciences, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'J Jill', 'Initials': 'JJ', 'LastName': 'Hopkins', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Chin-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Lorenz-Candlin', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Makadia', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shienal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Tam', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.11.004']
2697,33217697,Joint fatigue-failure: A demonstration of viscoelastic responses to rate and frequency loading parameters using the porcine cervical spine.,"Fatigue-failure in low back tissues is influenced by parameters of cyclic loading. Therefore, this study quantified the effect of loading rate and frequency on the number of tolerated compression cycles. Energy storage and vertical deformation were secondarily examined. Thirty-two porcine spinal units were randomly assigned to experimental groups that differed by loading rate (4.2 kN/s, 8.3 kN/s) and loading frequency (0.5 Hz, 1 Hz). Following preload and range-of-motion tests, specimens were cyclically loaded in a neutral posture until fatigue-failure occurred or 10800 cycles were tolerated. Macroscopic dissection was performed to identify the fracture morphology, and measurements of energy storage and vertical displacement were calculated throughout the specimen lifespan (1%, 10%, 50%, 90%, 99%). Given the differences in compression dose-force-time integral-between experimental conditions, the number of sustained cycles were assessed following linear and nonlinear dose-normalization via correction factors calculated from existing risk-exposure approximations. Without dose-normalization, an 8.3 kN/s loading rate and 0.5 Hz loading frequency reduced the fatigue lifetime by 3541 and 5977 cycles, respectively (p < 0.001). Linear and nonlinear dose-normalization resulted in a significant rate × frequency interaction (p < 0.001). For a 1 Hz loading frequency, the number of sustained loading cycles did not differ between loading rates (p adj  ≥ 0.988), but at 0.5 Hz, spinal units compressed at 8.3 kN/s sustained 99% (linear) and 97% (nonlinear) fewer cycles (p adj  < 0.001). These findings demonstrate that the interacting effects of loading frequency and loading rate on spinal fatigue-failure depend on the normalization of dose discrepancies between experimental groups.",2020,"For a 1 Hz loading frequency, the number of sustained loading cycles did not differ between loading rates (p adj  ≥ 0.988), but at 0.5 Hz, spinal units compressed at 8.3 kN/s sustained 99% (linear) and 97% (nonlinear) fewer cycles (p adj  < 0.001).","['Joint fatigue-failure', 'Thirty-two porcine spinal units', 'porcine cervical spine']",[],"['number of sustained loading cycles', 'Energy storage and vertical deformation', 'fatigue lifetime', 'loading frequency', 'Fatigue-failure', 'loading rate']","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0317484,"For a 1 Hz loading frequency, the number of sustained loading cycles did not differ between loading rates (p adj  ≥ 0.988), but at 0.5 Hz, spinal units compressed at 8.3 kN/s sustained 99% (linear) and 97% (nonlinear) fewer cycles (p adj  < 0.001).","[{'ForeName': 'Jackie D', 'Initials': 'JD', 'LastName': 'Zehr', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Jessa M', 'Initials': 'JM', 'LastName': 'Buchman-Pearle', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Jack P', 'Initials': 'JP', 'LastName': 'Callaghan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada. Electronic address: jack.callaghan@uwaterloo.ca.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.110081']
2698,33217700,Piloting the 'Youth Early-intervention Study' ('YES'): Preliminary functional outcomes of a randomized controlled trial targeting social participation and physical well-being in young people with emerging mental disorders.,"INTRODUCTION


Young people with mental disorders present with diverse social, vocational, physical, and developmental needs. However, multifaceted interventions are rare. We examine the effectiveness of a clinical trial targeting social participation and physical well-being in young people accessing clinical services.
METHODS


The 'Youth Early-intervention Study' ('YES') was an unblinded, two-phase, pilot randomized controlled trial offered as an adjunct to standard clinical care, consisting of group activities. Mixed effects models were used to examine functional outcomes over time measured by the 'Social and Occupational Functioning Assessment Scale', 'Functioning Assessment Short Test', and 'Brief Disability Questionnaire' (items 7 and 8).
RESULTS


133 participants aged 14-25 were recruited. 87 participants completed both arms and 83 participants completed a 12-month post-trial assessment. Functioning improved across all outcomes. While diagnoses differed in functioning at baseline (lower functioning in psychotic and bipolar disorders compared to depression), they did not differ in the rate of improvement across any measure. Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention. Engagement with education increased from 11% at baseline to 51% at 12-months post-trial and full-time employment increased from 8% at baseline to 20% at 12-months post-trial.
LIMITATIONS


Small sample, no control group, and unmeasured potential moderators (e.g. neurocognitive impairment).
CONCLUSIONS


'YES' was effective and preliminary positive outcomes were observed across all functional outcomes. Future studies should compare the 'YES' intervention to a treatment-as-usual control condition and conduct a multi-centre trial across early intervention service sites.",2020,"Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention.","['young people with emerging mental disorders', 'young people accessing clinical services', '87 participants completed both arms and 83 participants completed a 12-month post-trial assessment', '133 participants aged 14-25 were recruited', 'Young people with mental disorders']",[],"['full-time employment', ""Social and Occupational Functioning Assessment Scale', 'Functioning Assessment Short Test', and 'Brief Disability Questionnaire' (items 7 and 8"", 'Engagement with education']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",133.0,0.163707,"Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention.","[{'ForeName': 'Lillian J', 'Initials': 'LJ', 'LastName': 'Gehue', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Crouse', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia. Electronic address: jacob.crouse@sydney.edu.au.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Battisti', 'Affiliation': ""Cancer Centre for Children, The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Yim', 'Affiliation': ""St Vincent's Private Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Carpenter', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': ""Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia; St Vincent's and Mater Clinical School, The University of Notre Dame, NSW, Australia.""}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Hickie', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.070']
2699,33217717,"Weight stigma and media: An examination of the effect of advertising campaigns on weight bias, internalized weight bias, self-esteem, body image, and affect.","While some media perpetuate weight stigma and an ideal of thinness, certain advertising campaigns, such as Aerie Real and Dove Real Beauty, have attempted to promote body acceptance. The current study evaluated the influence of exposure to these campaigns on weight bias, internalized weight bias (IWB), self-esteem, body image, and affect relative to exposure to a campaign perpetuating the thin ideal and a documentary on weight stigma. 475 female participants were randomized to one of five conditions: Aerie, Dove, Victoria's Secret, an HBO documentary, or control (i.e., neutral video clip). Participants completed measures of weight bias, IWB, self-esteem, body image, and affect one week prior to and immediately after watching the assigned video clip. Results showed positive effects of the Aerie and Dove campaigns on women. While global measures of weight bias and IWB were unchanged, women who viewed the Dove and Aerie campaigns reported significantly improved self-esteem and positive affect. Further, women found the campaigns to have positive, uplifting, and empowering messages. Aerie's and Dove's acceptance-promoting advertising campaigns positively influenced self-esteem and mood, and they are potential tools for weight bias reduction. Advertisements and media have the potential to impact weight-based attitudes in society.",2020,"While global measures of weight bias and IWB were unchanged, women who viewed the Dove and Aerie campaigns reported significantly improved self-esteem and positive affect.",['475 female participants'],"[""Dove, Victoria's Secret, an HBO documentary, or control (i.e., neutral video clip""]","['Weight stigma and media', 'self-esteem', 'weight bias, internalized weight bias (IWB), self-esteem, body image', 'weight bias, internalized weight bias, self-esteem, body image, and affect', 'weight bias and IWB', 'weight bias, IWB, self-esteem, body image']","[{'cui': 'C4517786', 'cui_str': '475'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0325912', 'cui_str': 'Family Columbidae'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",475.0,0.0279557,"While global measures of weight bias and IWB were unchanged, women who viewed the Dove and Aerie campaigns reported significantly improved self-esteem and positive affect.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Selensky', 'Affiliation': 'East Carolina University, East Fifth Street, 104 Rawl Building, Greenville, NC 27858, United States. Electronic address: selenskyj15@ecualumni.ecu.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Carels', 'Affiliation': 'East Carolina University, East Fifth Street, 104 Rawl Building, Greenville, NC 27858, United States.'}]",Body image,['10.1016/j.bodyim.2020.10.008']
2700,33218310,"Evaluation of two family-based intervention programs for children affected by rare disease and their families - research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design.","BACKGROUND


Families of children with rare diseases (i.e., not more than 5 out of 10,000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and its siblings. Although families caring for children with rare diseases are known to be at risk for mental disorders, the evaluation of special programs under high methodological standards has not been conducted so far. Moreover, the implementation of interventions for this group into regular care has not yet been accomplished in Germany. The efficacy and cost-effectiveness of a family-based intervention will be assessed.
METHODS/DESIGN


The study is a 2x2 factorial randomized controlled multicenter trial conducted at 17 study centers throughout Germany. Participants are families with children and adolescents affected by a rare disease aged 0 to 21 years. Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months. Topics discussed in the interventions include coping, family relations, and social support. Families in the control condition will receive treatment as usual. The primary efficacy outcome is parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters. Further outcomes will be assessed from the parents' as well as the children's perspective. Participants are investigated at baseline, 6, 12 and 18 months after randomization. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed.
DISCUSSION


This paper describes the implementation and evaluation of two family-based intervention programs for Children Affected by Rare Disease and their Family's Network (CARE-FAM-NET) in German standard care. A methodologically challenging study design is used to reflect the complexity of the actual medical care situation. This trial could be an important contribution to the improvement of care for this highly burdened group.
TRIAL REGISTRATION


German Clinical Trials Register: DRKS00015859 (registered 18 December 2018) and ClinicalTrials.gov : NCT04339465 (registered 8 April 2020). Protocol Version: 15 August 2020 (Version 6.1). Trial status: Recruitment started on 1 January 2019 and will be completed on 31 March 2021.",2020,"Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months.","['children affected by rare disease and their families - research network (CARE-FAM-NET', ""Children Affected by Rare Disease and their Family's Network (CARE-FAM-NET) in German standard care"", 'Participants are families with children and adolescents affected by a rare disease aged 0 to 21\u2009years', '17 study centers throughout Germany', 'Families of children with rare diseases']",[],"['parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters', 'efficacy and cost-effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C0015610', 'cui_str': 'Family Research'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0060056', 'cui_str': 'FAM protocol'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",10000.0,0.0636024,"Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months.","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Boettcher', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. j.boettcher@uke.de.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Filter', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Denecke', 'Affiliation': 'Department of Pediatrics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Amra', 'Initials': 'A', 'LastName': 'Hot', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Zeidler', 'Affiliation': 'Center for Health Economics Research Hannover (CHERH), Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'J-Matthias Graf', 'Initials': 'JG', 'LastName': 'von der Schulenburg', 'Affiliation': 'Center for Health Economics Research Hannover (CHERH), Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Bullinger', 'Affiliation': 'Institute for Medical Psychology, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Rassenhofer', 'Affiliation': 'Department of Child- and Adolescent Psychiatry and Psychotherapy, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schulte-Markwort', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Wiegand-Grefe', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMC family practice,['10.1186/s12875-020-01312-9']
2701,33218498,Impact of physical therapists' instructions on function and the perception of post-dry needling soreness in mechanical cervical pain; a randomized clinical trial.,"BACKGROUND


To investigate the impact of physical therapists' instructions on the perception of post dry needling (DN) soreness and function in patients with mechanical neck pain.
METHODS


Seventy-five patients with neck pain were randomly assigned to three groups: ""positive"" group (n = 25) received positive verbal input; ""negative"" group (n = 25) received negative verbal input, and control group (n = 25) did not receive any input about post-needling soreness. All three groups received DN of a trigger point in the upper trapezius muscle. The subjective pain experience, pressure pain threshold (PPT), and neck disability Index (NDI) were assessed before and after DN.
RESULTS


Patients in all groups showed improvement in pain, PPT and NDI. There were no significant differences in pain (P = 0.41) and PPT (P = 0.68) in the positive and negative groups compared with the control group. Significant difference in function was seen with the NDI after DN of patients in the positive and negative groups compared with the control group (P = 0.011, standard error: 1.08-1.5).
CONCLUSION


Considering that the power of our study may be too low to draw more definitive conclusions, DN appears to be an effective technique to improve pain and mechanical hyperalgesia. The experience of post-needling soreness does not appear to influence the outcome of DN on pain, PPT, and NDI. Post-needling soreness does not seem to be a limiting factor in achieving acceptable outcomes, especially when clinicians offer DN within a therapeutic emphasizing a positive patient response. This study questions whether any treatments need to be offered to patients receiving DN.",2020,There were no significant differences in pain (P = 0.41) and PPT (P = 0.68) in the positive and negative groups compared with the control group.,"['mechanical cervical pain', 'patients with mechanical neck pain', 'patients receiving DN', 'Seventy-five patients with neck pain']","['positive"" group (n\xa0=\xa025) received positive verbal input; ""negative"" group (n\xa0=\xa025) received negative verbal input, and control group (n\xa0=\xa025) did not receive any input about post-needling soreness', ""physical therapists' instructions""]","['subjective pain experience, pressure pain threshold (PPT), and neck disability Index (NDI', 'pain, PPT and NDI', 'pain and mechanical hyperalgesia', 'function', 'pain, PPT, and NDI', 'pain']","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C4319621', 'cui_str': '75'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",75.0,0.084923,There were no significant differences in pain (P = 0.41) and PPT (P = 0.68) in the positive and negative groups compared with the control group.,"[{'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Almaee Nejad', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Iran. Electronic address: Almaeefarnaz@gmail.com.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dommerholt', 'Affiliation': 'Bethesda Physiocare, Bethesda, MD, USA; PhysioFitness, Rockville, MD, USA; Myopain Seminars, Bethesda, MD, USA. Electronic address: jan@myopain4u.com.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Attarbashi Moghadam', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Iran. Electronic address: attarbashi@tums.ac.ir.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Shadmehr', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Iran. Electronic address: shadmehr@tums.ac.ir.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khazaei Pour', 'Affiliation': 'Tehran University of Medical Sciences, Iran. Electronic address: z_kh14@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.023']
2702,33218502,Effects of core stabilization exercises on thickness and activity of trunk and hip muscles in subjects with nonspecific chronic low back pain.,"BACKGROUND


Changes in trunk and hip muscles are believed to be important in subjects with nonspecific chronic low back pain (NSCLBP), but little is known about specific changes, or how they might be affected by core stabilization exercises. The aim of this study was to compare six key muscles before and after these exercises.
METHODS


Thirty two NSCLBP patients were assigned randomly into two groups: exercise (n = 17) and control (n = 15). On 5 days per week for 4 weeks, the Exercise group performed 16 core stabilization exercises and the Control group received transcutaneous electrical nerve stimulation and a 'hot-pack'. Surface electromyography (EMG) was used to assess maximum bilateral activity of transversus abdominis (TrA), multifidus (MF) and gluteus maximus (Gmax) muscles. Ultrasound imaging was used to measure the rest and contracted thickness of these muscles. Pain and disability were assessed using a visual analogue scale (VAS) and the Oswestry Disability Index.
RESULTS


When left and right-side muscle data were combined, two-way ANOVAs showed a nonsignificant interaction effect for all dependent variables (P > 0.05), significant time effects on resting muscle thickness for TrA (P = 0.01), MF (P = 0.041) and Gmax (P = 0.003), EMG signals of TrA (P = 0.038), pain and disability (P = 0.000). There were a significant group effect on contracted thickness for TrA (P = 0.032) and Gmax (P = 0.026) and disability (P = 0.017).
CONCLUSIONS


Core stabilization exercises increased contracted thickness of TrA and Gmax muscles and decreased disability in subjects with NSCLBP.",2020,"EMG signals of TrA (P = 0.038), pain and disability (P = 0.000).","['Thirty', 'subjects with NSCLBP', 'subjects with nonspecific chronic low back pain (NSCLBP', 'subjects with nonspecific chronic low back pain', 'two NSCLBP patients']","['Core stabilization exercises', 'core stabilization exercises', 'Surface electromyography (EMG', ""Exercise group performed 16 core stabilization exercises and the Control group received transcutaneous electrical nerve stimulation and a 'hot-pack""]","['resting muscle thickness for TrA', 'disability', 'EMG signals of TrA', 'thickness and activity of trunk and hip muscles', 'contracted thickness of TrA and Gmax muscles and decreased disability', 'maximum bilateral activity of transversus abdominis (TrA), multifidus (MF) and gluteus maximus (Gmax) muscles', 'Pain and disability', 'contracted thickness for TrA', 'visual analogue scale (VAS) and the Oswestry Disability Index', 'MF', 'pain and disability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",32.0,0.0311839,"EMG signals of TrA (P = 0.038), pain and disability (P = 0.000).","[{'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Narouei', 'Affiliation': 'Tehran University, School of Sport Medicine Sciences, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Barati', 'Affiliation': 'Shahid beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran. Electronic address: ahbarati20@gmail.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Akuzawa', 'Affiliation': 'Waseda University, School of Sport Sciences, Japan.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Talebian', 'Affiliation': 'Tehran University, School of Rehabilitation Sciences, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Ghiasi', 'Affiliation': 'Zahedan University of Medical Sciences, School of Rehabilitation Sciences, Iran.'}, {'ForeName': 'Asghar', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Zahedan University of Medical Sciences, School of Rehabilitation Sciences, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Alizadeh', 'Affiliation': 'Tehran University, School of Sport Medicine Sciences, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.026']
2703,33218508,Effect of Pilates Matwork exercises on posterior chain flexibility and trunk mobility in school children: A randomized clinical trial.,"OBJECTIVE


To investigate the effects of an exercise program, based on the Pilates Matwork method, on posterior chain flexibility and trunk mobility in healthy school age children.
DESIGN AND SETTING


The study was a parallel-group randomized clinical trial. The participants were randomly assigned to groups: Pilates Group (PG) and Control Group (CG). The program was developed at the Early Childhood Education Institute, Londrina-PR.
PARTICIPANTS


43 children with age between eight to 12 years, no prior knowledge of the Pilates method, and no exercise training in the last six months.
INTERVENTION


Four months of twice a week 50 min Pilates Matwork exercises were administered.
OUTCOME MEASURES


Flexibility and mobility, assessed using the sit-and-reach test, fingertip-to-floor test and photogrammetry. The assessors were blinded to the allocation of participants.
RESULTS


Three children were excluded before randomization and 40 were randomized (PG n = 20; CG n = 20).12 children were excluded during the protocol (PG n = 7; CG n = 5) and included in the intention to treat analysis. No significant difference between groups was observed for flexibility measures. There was a significant difference in the following outcomes for the PG: distance reached in the sit-and-reach test between pre-test (median 14.25[11.25-28.38]) and post-test (median 20.25[12.00-29.63]) (ES = 0.29, SRM = 0.73); Posterior angle of the knee in the fingertip-to-floor test between pre-test (median 191.60[187.20-191.60]) and post-test (median 189.00[185.90-191.50]) (ES = 0.56, SRM = 0.54).
CONCLUSION


There were no differences in posterior chain flexibility and trunk mobility between school age children who underwent Pilates Matwork exercises and the control. However, children who participated in the exercise program showed improvement in some results of flexibility.
CLINICAL TRIAL REGISTRATION NUMBER


Brazilian Registry of Clinical Trials (REBEC) (N° RBR-8t5p7d).",2020,There was a significant difference in the following outcomes for the PG: distance reached in the sit-and-reach test between pre-test (median 14.25[11.25-28.38]) and post-test (median 20.25[12.00-29.63]),"['Three children were excluded before randomization and 40 were randomized (PG n\xa0=\xa020; CG n\xa0=\xa020).12 children', '43 children with age between eight to 12 years, no prior knowledge of the Pilates method, and no exercise training in the last six months', 'healthy school age children', 'school children']","['exercise program', 'Pilates Matwork exercises', 'Pilates Group (PG) and Control Group (CG']","['flexibility', 'posterior chain flexibility and trunk mobility', 'Flexibility and mobility, assessed using the sit-and-reach test, fingertip-to-floor test and photogrammetry', 'flexibility measures', 'PG: distance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0729895', 'cui_str': 'Tip of finger'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0031747', 'cui_str': 'Photogrammetry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",43.0,0.135763,There was a significant difference in the following outcomes for the PG: distance reached in the sit-and-reach test between pre-test (median 14.25[11.25-28.38]) and post-test (median 20.25[12.00-29.63]),"[{'ForeName': 'Fabíola Unbehaun', 'Initials': 'FU', 'LastName': 'Cibinello', 'Affiliation': 'Universidade Estadual de Londrina, CEPPOS - Centro de Pós-Graduação Professor Dr. Darli Antonio Soares, Av. Robert Koch, 60 - Vila Operária, Londrina, Paraná, Brazil. Electronic address: dirce_fujisawa@uel.br.'}, {'ForeName': 'Jessica Caroliny', 'Initials': 'JC', 'LastName': 'de Jesus Neves', 'Affiliation': 'Universidade Estadual de Londrina, CEPPOS - Centro de Pós-Graduação Professor Dr. Darli Antonio Soares, Av. Robert Koch, 60 - Vila Operária, Londrina, Paraná, Brazil.'}, {'ForeName': 'Mônica Yosino Leão', 'Initials': 'MYL', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Estadual de Londrina, CEPPOS - Centro de Pós-Graduação Professor Dr. Darli Antonio Soares, Av. Robert Koch, 60 - Vila Operária, Londrina, Paraná, Brazil.'}, {'ForeName': 'Paola Janeiro', 'Initials': 'PJ', 'LastName': 'Valenciano', 'Affiliation': 'Universidade Estadual de Londrina, CEPPOS - Centro de Pós-Graduação Professor Dr. Darli Antonio Soares, Av. Robert Koch, 60 - Vila Operária, Londrina, Paraná, Brazil.'}, {'ForeName': 'Dirce Shizuko', 'Initials': 'DS', 'LastName': 'Fujisawa', 'Affiliation': 'Universidade Estadual de Londrina, CEPPOS - Centro de Pós-Graduação Professor Dr. Darli Antonio Soares, Av. Robert Koch, 60 - Vila Operária, Londrina, Paraná, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.016']
2704,33218510,"Investigating the effects of myofascial induction therapy techniques on pain, function and quality of life in patients with chronic low back pain.","INTRODUCTION


Low back pain (LBP) is well documented as a common health problem; it is the leading cause of activity limitation and work absence throughout much of the world, and it causes an enormous economic burden on individuals, families, communities, industry, and governments. The aim of this study was to comparatively investigate the effects of myofascial induction therapy (MIT) against pain neuroscience education (PNE) on pain and function in patients with chronic low back pain (CLBP).
METHOD


Forty patients with CLBP were included and randomly divided into two groups according to the treatment program (40 min/session, 2 sessions/week during 8-week), as follows: the MIT and the PNE groups. The outcome measures were the fear-avoidance beliefs questionnaire (FABQ), Roland Morris disability questionnaire, McGill pain questionnaire, finger floor test, SF-36 quality-of-life questionnaire, and thoracolumbar fascia ultrasound imaging results. Patients were evaluated before and after treatment.
RESULTS


Within both groups, all outcome scores showed a significant improvement (p < 0.05). After 8-week, SF-36 physical function, physical role and mental health scores significantly improved in MIT group compared with PNE group, finger floor test score significantly decreased in MIT group compared with PNE group, and FABQ score significantly decreased in PNE group compared with MIT group (p < 0.05).
CONCLUSIONS


Although both MIT and PNE were found to be effective on pain and function in patients with CLBP, MIT techniques were substantially better in improving the mobility of trunk flexion and quality of life in these patients.",2020,"After 8-week, SF-36 physical function, physical role and mental health scores significantly improved in MIT group compared with PNE group, finger floor test score significantly decreased in MIT group compared with PNE group, and FABQ score significantly decreased in PNE group compared with MIT group (p < 0.05).
","['Forty patients with CLBP', 'patients with chronic low back pain', 'patients with chronic low back pain (CLBP']","['MIT and PNE', 'MIT', 'myofascial induction therapy (MIT) against pain neuroscience education (PNE', 'myofascial induction therapy techniques', 'PNE']","['finger floor test score', 'pain and function', 'pain, function and quality of life', 'FABQ score', 'SF-36 physical function, physical role and mental health scores', 'mobility of trunk flexion and quality of life', 'fear-avoidance beliefs questionnaire (FABQ), Roland Morris disability questionnaire, McGill pain questionnaire, finger floor test, SF-36 quality-of-life questionnaire, and thoracolumbar fascia ultrasound imaging results']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0225206', 'cui_str': 'Structure of thoracolumbar fascia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",40.0,0.0269221,"After 8-week, SF-36 physical function, physical role and mental health scores significantly improved in MIT group compared with PNE group, finger floor test score significantly decreased in MIT group compared with PNE group, and FABQ score significantly decreased in PNE group compared with MIT group (p < 0.05).
","[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ünal', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Medipol University of Health Sciences Institute, Turkey. Electronic address: fztmehmet6@gmail.com.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'Evci K', 'Affiliation': 'Radiology Department, Kocaeli Private Cihan Hospital, Turkey. Electronic address: eevcik@yahoo.com.'}, {'ForeName': 'Muammer', 'Initials': 'M', 'LastName': 'Kocatürk', 'Affiliation': 'Department of Orthopedics, Kocaeli Private Cihan Hospital, Turkey. Electronic address: mkocaturk41@gmail.com.'}, {'ForeName': 'Z Candan', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Medipol University of Health Sciences Institute, Turkey. Electronic address: calgun@medipol.edu.tr.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.014']
2705,33218517,Pain Neuroscience Education in cancer survivors with persistent pain: A pilot study.,"PURPOSE


To describe the Pilot Study: Pain Neuroscience Education in Cancer Survivors and describe the innovative educational component of Pain Neuroscience Education (PNE).
DESIGN


Quasi experimental design.
METHOD


The PNE program, encompassing a one-on-one education session and an information leaflet was given to 30 cancer survivors. At baseline and two weeks after the PNE, participants were asked to fill out following outcome measures; pain intensity, pain catastrophizing, and HRQoL.
FINDINGS


Following PNE, a significant decrease on pain intensity (p = 0.001), on the SF-36 subscale pain (p = 0.003) and for the following PCS subscales: Helplessness (p < 0.001), Rumination (p = 0.002) and Total score (p < 0.001) was found compared to baseline.
CONCLUSIONS


Although the current results need to be verified in a larger randomized, controlled trial, preliminary evidence shows a decrease in pain intensity and pain catastrophizing following PNE in cancer survivors with persistent pain.",2020,"At baseline and two weeks after the PNE, participants were asked to fill out following outcome measures; pain intensity, pain catastrophizing, and HRQoL.
FINDINGS


Following PNE, a significant decrease on pain intensity (p = 0.001), on the SF-36 subscale pain (p = 0.003) and for the following PCS subscales: Helplessness (p < 0.001), Rumination (p = 0.002) and Total score (p < 0.001) was found compared to baseline.
","['Cancer Survivors', 'cancer survivors with persistent pain']",['Pain Neuroscience Education'],"['Rumination', 'pain intensity', 'pain intensity and pain catastrophizing', 'PCS subscales: Helplessness', 'SF-36 subscale pain', 'pain intensity, pain catastrophizing, and HRQoL.\nFINDINGS\n\n\nFollowing PNE', 'Total score']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0018897', 'cui_str': 'Learned Helplessness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.168613,"At baseline and two weeks after the PNE, participants were asked to fill out following outcome measures; pain intensity, pain catastrophizing, and HRQoL.
FINDINGS


Following PNE, a significant decrease on pain intensity (p = 0.001), on the SF-36 subscale pain (p = 0.003) and for the following PCS subscales: Helplessness (p < 0.001), Rumination (p = 0.002) and Total score (p < 0.001) was found compared to baseline.
","[{'ForeName': 'Roselien', 'Initials': 'R', 'LastName': 'Pas', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium; Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. Electronic address: roselien.pas@vub.be.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Leysen', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'De Goeij', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium; The Berekuyl Academy, Harderwijk, the Netherlands.'}, {'ForeName': 'Leonieke', 'Initials': 'L', 'LastName': 'Vossebeld', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy (KIMA), Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussel, Belgium; The Berekuyl Academy, Harderwijk, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Wilgen', 'Affiliation': 'Pain in Motion International Research Group, Belgium; Transcare Transdisciplinary Pain Management Centre, Groningen, the Netherlands.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'De Groef', 'Affiliation': 'KU Leuven - University of Leuven, Department of Rehabilitation Sciences and University Hospitals Leuven, Department of Physical Medicine and Rehabilitation, Leuven, Belgium.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'De Kooning', 'Affiliation': 'Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium; Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussel, Belgium.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.027']
2706,33218519,Effect of fascial Manipulation® on reaction time.,"INTRODUCTION


This study aimed to investigate the effects of fascial manipulation (FM) on muscle force and electrical activity.
METHODS


Sixty healthy adult participants were randomly assigned to the FM intervention group (FM group; n = 20), static stretching intervention group (SS group; n = 20), and control group (C group; n = 20). The FM group underwent FM for the right brachial fascia (antecubitus) for 210 s. The SS group underwent static stretching of the right biceps brachii for 210 s. The C group was supine for 210 s. Participants were asked to flex the right elbow joint as quickly as possible after a light signal appeared during three sessions (before, immediately after, and 1 week after the intervention). During each session, the muscle activity of the right biceps brachii and bending force of the right elbow joint were measured. We calculated the reaction time (RT), pre-motor time (PMT), motor time (MT), time to peak force (TPF), and time to peak activity (TPA) from these measurements.
RESULTS


The RT, MT, TPA, and TPF of the FM group were significantly shorter immediately after or 1 week after the intervention compared with those before the intervention. The RT, MT, TPA, and TPF of the FM group were significantly shorter than those of the SS group or C group immediately after or 1 week after the intervention.
CONCLUSION


FM improved RT, MT, TPA, and TPA, and the effects lasted for 1 week. Both mechanical and neurological factors may contribute to improvements in motor performance after FM.",2020,"The RT, MT, TPA, and TPF of the FM group were significantly shorter than those of the SS group or C group immediately after or 1 week after the intervention.
",['Sixty healthy adult participants'],"['FM', 'static stretching of the right biceps brachii for 210\xa0s', 'FM intervention group (FM group; n\xa0=\xa020), static stretching intervention group (SS group; n\xa0=\xa020), and control group (C group; n\xa0=\xa020', 'fascial Manipulation®', 'SS', 'fascial manipulation (FM']","['RT, MT, TPA, and TPA', 'reaction time', 'muscle activity of the right biceps brachii and bending force of the right elbow joint', 'reaction time (RT), pre-motor time (PMT), motor time (MT), time to peak force (TPF), and time to peak activity (TPA']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0011119', 'cui_str': 'Bends'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0230353', 'cui_str': 'Right elbow region structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",60.0,0.0177809,"The RT, MT, TPA, and TPF of the FM group were significantly shorter than those of the SS group or C group immediately after or 1 week after the intervention.
","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sawamura', 'Affiliation': 'Department of General Rehabilitation, Kizawa Memorial Hospital, 590 Shimokobi, Kobi-cho, Minokamo-City, Gifu, 505-0034, Japan. Electronic address: sawarm123@yahoo.co.jp.'}, {'ForeName': 'Akichika', 'Initials': 'A', 'LastName': 'Mikami', 'Affiliation': 'Faculty of Nursing and Rehabilitation, Chubu Gakuin University, 2-1 Kirigaoka, Seki-City, Gifu, 501-3993, Japan. Electronic address: mikami@chubu-gu.ac.jp.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.003']
2707,33218522,"Short term relief of multisite chronicpain with Bowen Therapy: A double-blind, randomized controlled trial.","INTRODUCTION


Bowen Therapy, a form of soft tissue manipulation, is commonly used to treat musculoskeletal conditions; yet, there is little evidence for its efficacy. The goal of the study was to investigate the impact of Bowen Therapy on pain and function in people with chronic pain in multiple locations. Additionally, we examined the mechanisms of effect through monitoring the nociceptive and autonomic nervous systems.
METHOD


The study was a double-blind, randomized controlled trial involving 31 people with chronic pain. Participants were randomized into real and sham therapy groups. Each group received 6 sessions of therapy over 8 weeks. The primary outcome measures of pain and function were assessed using standard questionnaires. Quantitative sensory testing was used to assess the nociceptive system, while recordings of heart rate variability and skin conductance were used to assess the autonomic nervous system. Outcome measures were assessed at baseline and at 1- and 6-weeks following completion of the intervention.
RESULTS


The real therapy group had a significantly lower pain score 1-week following the intervention compared to the sham group. There were no differences between groups at the final follow-up or in the function measures. There was no significant change in the nociceptive measures but there was evidence of increased activation of the sympathetic nervous system.
DISCUSSION


Bowen Therapy gave rise to a short-term reduction in pain that was not evident in a sham therapy group. The mechanisms of action of Bowen Therapy remain uncertain but may involve sympathoexcitation.",2020,There were no differences between groups at the final follow-up or in the function measures.,"['31 people with chronic pain', 'people with chronic pain in multiple locations']","['multisite chronicpain with Bowen Therapy', 'Bowen Therapy']","['pain score', 'nociceptive measures', 'pain', 'pain and function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",31.0,0.199741,There were no differences between groups at the final follow-up or in the function measures.,"[{'ForeName': 'Kiho', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Otago Bowen Therapy, Dunedin, New Zealand.'}, {'ForeName': 'Gwyn N', 'Initials': 'GN', 'LastName': 'Lewis', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand. Electronic address: gwyn.lewis@aut.ac.nz.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.025']
2708,33218524,"Effects of a pedometer-based walking intervention on young adults' sleep quality, stress and life satisfaction: Randomized controlled trial.","OBJECTIVE


The purpose of this study was to evaluate the effect of daily walking exercise on sleep quality, perceived stress and life satisfaction. It aimed to investigate the interaction between daily walking exercise and sleep components (sleep quality, sleep latency, sleep duration, sleep disturbance, sleep medication use, and daytime functioning).
METHODS


A four-week randomized control trial (RCT) was conducted by assigning 54 research volunteers into two groups randomly. The participants in the intervention group (IG) were asked to carry out a daily aerobic walking exercise (DAWE), and participants in the control group (CG) were requested to maintain a sedentary life style. Sleep quality, perceived stress and life satisfaction were assessed at the baseline and at the end of the intervention. All participants were equipped with Omron HJ-112 pedometer to record their daily exercise and to fulfil a daily diary sheet.
RESULTS


By the end of the intervention, 26 out of 54 participants (M age  = 24.96; SD = 5.13) completed the task. There was no statistical significance between the two groups when comparing global sleep quality, stress and life satisfaction. The within group comparison showed positive effect of DAWE on subjective sleep quality (p = 0.05), less sleep medication use (p < 0.05), positive effect on daytime function (p < 0.01) and improved life satisfaction (p = 0.05) after four weeks of intervention.
CONCLUSION


Findings suggested that incorporating daily aerobic walking exercise might be beneficial to sleep health. Further studies are suggested to ascertain the pedometer-based daily walking exercise's long-term effects and to unfold the biological mechanisms leading to its sleep quality improvement effect.",2020,"The within group comparison showed positive effect of DAWE on subjective sleep quality (p = 0.05), less sleep medication use (p < 0.05), positive effect on daytime function (p < 0.01) and improved life satisfaction (p = 0.05) after four weeks of intervention.
","['young adults', '26 out of 54 participants (M age \xa0=\xa024.96; SD\xa0=\xa05.13) completed the task', '54 research volunteers into two groups randomly']","['daily walking exercise', 'pedometer-based walking intervention', 'aerobic walking exercise', 'Omron HJ-112 pedometer to record their daily exercise and to fulfil a daily diary sheet', 'daily aerobic walking exercise (DAWE), and participants in the control group (CG) were requested to maintain a sedentary life style']","['subjective sleep quality', 'daily walking exercise and sleep components (sleep quality, sleep latency, sleep duration, sleep disturbance, sleep medication use, and daytime functioning', 'sleep quality, perceived stress and life satisfaction', 'life satisfaction', 'sleep medication use', 'Sleep quality, perceived stress and life satisfaction', 'global sleep quality, stress and life satisfaction', 'sleep quality, stress and life satisfaction', 'daytime function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",54.0,0.053409,"The within group comparison showed positive effect of DAWE on subjective sleep quality (p = 0.05), less sleep medication use (p < 0.05), positive effect on daytime function (p < 0.01) and improved life satisfaction (p = 0.05) after four weeks of intervention.
","[{'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Institute of Health Promotion & Sport Sciences, Faculty of Education & Psychology, ELTE Eötvös Loránd University, Budapest, Hungary. Electronic address: feifei.wang@ppk.elte.hu.'}, {'ForeName': 'Szilvia', 'Initials': 'S', 'LastName': 'Boros', 'Affiliation': 'Institute of Health Promotion & Sport Sciences, Faculty of Education & Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.011']
2709,33218532,Effects of kettlebell training and detraining on mood status and sleep and life quality of healthy women.,"BACKGROUND AND PURPOSE


Kettlebell exercise have become popular because of its ability to simultaneously train aerobic/anaerobic systems, low cost and easy access, and the great potential for physical fitness programs with a focus on public health. However, little is known about its effects on mood status, sleep, and quality of life (QOL) parameters. The aim of the present study was to examine the effects of kettlebell training/detraining on the prevention of depressive and anxiety symptoms and QOL and sleep quality.
METHODS


The sample was composed of 17 healthy women (age: 26.0 ± 5.0 years; body mass: 60.9 ± 12.5 kg; height: 164.6 ± 5.5 cm). The study was organized into four consecutive phases: pre-intervention (PRE), intervention (kettlebell training, 12 weeks, three times/week), post-intervention (POST) and detraining (D, four weeks). The questionnaires SF-36 (QOL), Beck (depressive symptoms), State-Anxiety Inventory (acute anxiety symptoms), POMS (mood state) and the Pittsburgh Sleep Quality Index (sleep quality) were administered at PRE/POST/D phases.
RESULTS


QOL, anxiety, sleep quality, and mood state exhibited no differences between PRE/POST/D. Levels of depressive symptoms significantly decreased (22.0%, p = 0.003) between PRE and POST phases, and remained low and similar to POST levels after D.
CONCLUSION


Twelve weeks of kettlebell training was able to reduce and prevent depressive/anxiety symptoms in healthy women and these results were maintained after short-term detraining. Thus, kettlebell training might be considered an alternative method on the promotion of mental health and prevention of mood disorders and consequently can improve QOL even in health people.",2020,"RESULTS


QOL, anxiety, sleep quality, and mood state exhibited no differences between PRE/POST/D. Levels of depressive symptoms significantly decreased (22.0%, p = 0.003) between PRE and POST phases, and remained low and similar to POST levels after D.
CONCLUSION


Twelve weeks of kettlebell training was able to reduce and prevent depressive/anxiety symptoms in healthy women and these results were maintained after short-term detraining.","['17 healthy women (age: 26.0\xa0±\xa05.0 years; body mass: 60.9\xa0±\xa012.5\xa0kg; height: 164.6\xa0±\xa05.5\xa0cm', 'healthy women']","['kettlebell training and detraining', 'kettlebell training/detraining', 'pre-intervention (PRE), intervention (kettlebell training']","['depressive/anxiety symptoms', 'questionnaires SF-36 (QOL), Beck (depressive symptoms), State-Anxiety Inventory (acute anxiety symptoms), POMS (mood state) and the Pittsburgh Sleep Quality Index (sleep quality', 'mood status, sleep, and quality of life (QOL) parameters', 'QOL, anxiety, sleep quality, and mood state', 'depressive and anxiety symptoms and QOL and sleep quality', 'PRE/POST/D. Levels of depressive symptoms', 'mood status and sleep and life quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C3844008', 'cui_str': '5.5'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",17.0,0.0229735,"RESULTS


QOL, anxiety, sleep quality, and mood state exhibited no differences between PRE/POST/D. Levels of depressive symptoms significantly decreased (22.0%, p = 0.003) between PRE and POST phases, and remained low and similar to POST levels after D.
CONCLUSION


Twelve weeks of kettlebell training was able to reduce and prevent depressive/anxiety symptoms in healthy women and these results were maintained after short-term detraining.","[{'ForeName': 'Weverton', 'Initials': 'W', 'LastName': 'Rufo-Tavares', 'Affiliation': 'Centro de EducaçãoFísica e Desportos (CEFD), Universidade Federal Do Espírito Santo (UFES), Av. Fernando Ferrari, 514 Goiabeiras, Zip code: 29075810, Vitória, ES, Brazil. Electronic address: weverton05@gmail.com.'}, {'ForeName': 'Claudio Andre', 'Initials': 'CA', 'LastName': 'Barbosa Lira', 'Affiliation': 'Setor de Fisiologia Humana e Do Exercício, Faculdade de Educação Física e Dança, Universidade Federal de Goiás (UFG), Avenida Esperança S/n, Campus Samambaia, Zip code: 74690-900, Goiânia, GO, Brazil. Electronic address: andre.claudio@gmail.com.'}, {'ForeName': 'Marilia Santos', 'Initials': 'MS', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Fisiologia, Universidade Federal de São Paulo (UNIFESP), Rua Botucatu, 862, 5° Andar, Zip code: 04023-062, São Paulo, SP, Brazil. Electronic address: marilia1707@gmail.com.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Zimerer', 'Affiliation': 'Centro de EducaçãoFísica e Desportos (CEFD), Universidade Federal Do Espírito Santo (UFES), Av. Fernando Ferrari, 514 Goiabeiras, Zip code: 29075810, Vitória, ES, Brazil. Electronic address: czimerer@gmail.com.'}, {'ForeName': 'André Soares', 'Initials': 'AS', 'LastName': 'Leopoldo', 'Affiliation': 'Centro de EducaçãoFísica e Desportos (CEFD), Universidade Federal Do Espírito Santo (UFES), Av. Fernando Ferrari, 514 Goiabeiras, Zip code: 29075810, Vitória, ES, Brazil. Electronic address: andresoaresleopoldo@gmail.com.'}, {'ForeName': 'Karine Jacon', 'Initials': 'KJ', 'LastName': 'Sarro', 'Affiliation': 'Faculdade de Educação Física, Universidade Estadual de Campinas (UNICAMP), Av. Érico Veríssimo, 701, Cidade Universitária ""Zeferino Vaz"", Zip code: 13.083-851, Barão Geraldo, Campinas, São Paulo, SP, Brazil. Electronic address: karine.sarro@fef.unicamp.br.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'Setor de Fisiologia Humana e Do Exercício, Faculdade de Educação Física e Dança, Universidade Federal de Goiás (UFG), Avenida Esperança S/n, Campus Samambaia, Zip code: 74690-900, Goiânia, GO, Brazil. Electronic address: paulogentil@hotmail.com.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, Nikaia, Thermopylo, 7, Zip code 18450, Nikaia, Greece. Electronic address: pademil@hotmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland. Electronic address: thomas.rosemann@usz.ch.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Medbase St. Gallen Am Vadianplatz, St. Gallen and Institute of Primary Care, University of Zurich, Zurich, Switzerland. Electronic address: beat.knechtle@hispeed.ch.'}, {'ForeName': 'Rodrigo Luiz', 'Initials': 'RL', 'LastName': 'Vancini', 'Affiliation': 'Centro de EducaçãoFísica e Desportos (CEFD), Universidade Federal Do Espírito Santo (UFES), Av. Fernando Ferrari, 514 Goiabeiras, Zip code: 29075810, Vitória, ES, Brazil. Electronic address: rodrigoluizvancini@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.006']
2710,33218553,Hemodynamic and creatine kinase changes after a 12-week equipment-based Pilates training program in hypertensive women.,"Exercise therapy is a conservative strategy to manage hypertension. The aim of this study was to investigate the effects of a 12-week equipment-based Pilates training program on the hemodynamics of medication-controlled hypertensive women. Forty-five women were classified into two groups: medication-controlled hypertensive (n = 30) or control (n = 15). To be eligible for the hypertensive group, participants had to have a clinical diagnosis of hypertension, be taking medication to control their blood pressure and not to have done any exercise activity in the previous three months. In the control group, the participants needed to have normal blood pressure levels and not to have done any exercise activity in the previous three months. All women participated in a 12-week equipment-based Pilates training program (2 × 60min sessions per week). Systolic and diastolic blood pressure (SBP, DBP), heart rate (HR) and creatine kinase levels (CK) were assessed before and after the program. SBP, DBP and heart rate were also assessed before and after each session. There was no statistically significant difference after Pilates training for systolic (normotensive MD 4.1, 95%CI -9.2 to 17.5, hypertensive MD 3.8, 95%CI -5.3 to 13.1) and diastolic (normotensive MD 5.8, 95%CI -2.0 to 13.7, hypertensive MD 4.0, 95%CI -4.3 to 12.4) blood pressure. Heart rate was reduced after Pilates training in both normotensive (MD 4.5, 95%CI 1.1 to 7.8) and medication-controlled hypertensive (MD 7.9, 95%CI 4.4 to 11.4) women. Creatine kinase activity was reduced after Pilates training in medication-controlled hypertensive women (p = 0.019). Blood pressure was not altered, but heart rate and creatinine kinase activity were reduced following 12 weeks of Equipment-based Pilates training.",2020,Creatine kinase activity was reduced after Pilates training in medication-controlled hypertensive women (p = 0.019).,"['hypertensive group, participants had to have a clinical diagnosis of hypertension, be taking medication to control their blood pressure and not to have done any exercise activity in the previous three months', 'Forty-five women were classified into two groups: medication-controlled hypertensive (n\xa0=\xa030) or control (n\xa0=\xa015', 'hypertensive women', 'All women participated in a 12-week', 'medication-controlled hypertensive women']","['equipment-based Pilates training program', 'Exercise therapy']","['normal blood pressure levels', 'SBP, DBP and heart rate', 'Blood pressure', 'Creatine kinase activity', 'Systolic and diastolic blood pressure (SBP, DBP), heart rate (HR) and creatine kinase levels (CK', 'blood pressure', 'Heart rate', 'heart rate and creatinine kinase activity']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0750863', 'cui_str': 'Finding of creatine kinase level'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}]",45.0,0.0232274,Creatine kinase activity was reduced after Pilates training in medication-controlled hypertensive women (p = 0.019).,"[{'ForeName': 'Juviane Meneses Dos', 'Initials': 'JMD', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe, Brazil; Graduate Program in Physical Education, Federal University of Sergipe, Brazil.'}, {'ForeName': 'Luis Fernando', 'Initials': 'LF', 'LastName': 'Sousa Filho', 'Affiliation': 'Department of Physiotherapy, Federal University of Sergipe, Brazil; Graduate Program in Physical Education, Federal University of Sergipe, Brazil.'}, {'ForeName': 'Vitor Oliveira', 'Initials': 'VO', 'LastName': 'Carvalho', 'Affiliation': 'Department of Physiotherapy, Federal University of Sergipe, Brazil.'}, {'ForeName': 'Rogério Brandão', 'Initials': 'RB', 'LastName': 'Wichi', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Sergipe, Brazil.'}, {'ForeName': 'Evaleide Diniz de', 'Initials': 'ED', 'LastName': 'Oliveira', 'Affiliation': 'Department of Physiotherapy, Federal University of Sergipe, Brazil. Electronic address: evaleide@ufs.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.020']
2711,33218555,Effects of non-manipulative osteopathic management in addition to physical therapy and rehabilitation on clinical outcomes of ankylosing spondylitis patients: A preliminary randomized clinical trial.,"INTRODUCTION


Ankylosing Spondylitis (AS) is reported to impair quality of life, physical and functional ability of patients. Rehabilitation and physical therapy is usually proposed to improve AS patient clinical conditions. Besides, an osteopathic management has not been extensively studied in the field of inflammatory diseases. = OBJECTIVE: To investigate the effects of osteopathic approach in addition to conventional rehabilitation management on clinical and functional outcomes among patients with AS.
EQUIPMENT AND METHODS


Eighteen patients with AS were recruited to participate to a physical therapy and rehabilitation (PTR) program over an 18-week period. They were randomly allocated into two groups to complete PTR only or PTR combined with osteopathic management without manipulative techniques (OSTEO group). Thoracolumbar maximal isometric strength (for flexion, extension, lateroflexion, and axial rotation) and flexibility, functional index, pain intensity and quality of life (self-assessment questionnaires) were assessed before and after the protocol.
RESULTS


Significant improvements were observed for the OSTEO group in strength, flexibility, disease activity and pain compared to the PTR group. However the difference between groups did not reach statistical significance for all the post-intervention measures. No significant correlation was found between functional, disability data or pain intensity and disease duration for both groups.
CONCLUSION


The results suggest that osteopathic management in addition to a physical therapy and rehabilitation program may be beneficial for individuals who suffer from AS. Further investigations are required using larger sample sizes to confirm these preliminary results.",2020,"RESULTS


Significant improvements were observed for the OSTEO group in strength, flexibility, disease activity and pain compared to the PTR group.","['ankylosing spondylitis patients', 'individuals who suffer from AS', 'patients with AS', 'Eighteen patients with AS were recruited to participate to a physical therapy and rehabilitation (PTR) program over an 18-week period']","['Rehabilitation and physical therapy', 'osteopathic approach', 'PTR only or PTR combined with osteopathic management without manipulative techniques', 'non-manipulative osteopathic management', 'physical therapy and rehabilitation', 'conventional rehabilitation management']","['Thoracolumbar maximal isometric strength (for flexion, extension, lateroflexion, and axial rotation) and flexibility, functional index, pain intensity and quality of life (self-assessment questionnaires', 'strength, flexibility, disease activity and pain', 'functional, disability data or pain intensity and disease duration']","[{'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0333046', 'cui_str': 'Lateral displacement'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",18.0,0.0223335,"RESULTS


Significant improvements were observed for the OSTEO group in strength, flexibility, disease activity and pain compared to the PTR group.","[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Seiler', 'Affiliation': 'Department of Physical Rehabilitation, Unit for Osteopathic Treatment, Erasme Hospital, Brussels, Belgium.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Vermeylen', 'Affiliation': 'Department of Physical Rehabilitation, Unit for Osteopathic Treatment, Erasme Hospital, Brussels, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Poortmans', 'Affiliation': 'Department of Physical Rehabilitation, Unit for Osteopathic Treatment, Erasme Hospital, Brussels, Belgium.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Feipel', 'Affiliation': 'Laboratory of Functional Anatomy, Faculty for Motor Sciences, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Dugailly', 'Affiliation': 'Laboratory of Functional Anatomy, Faculty for Motor Sciences, Université Libre de Bruxelles, Brussels, Belgium; Department of Osteopathy, CESPU-Escola Superior de Saúde do Vale do Ave, Famalicão, Portugal. Electronic address: pdugaill@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.028']
2712,33218556,Effectiveness of massage on flexibility of hamstring muscle and agility of female players: An experimental randomized controlled trial.,"OBJECTIVES


This study aimeded to examine acute and late effects of five consecutive sessions of Swedish massage on hamstring flexibility and agility of players.
METHODS


Arandom sample of 34 female players having bilateral tight hamstrings [passive straight leg raise ≤70° and active knee extension test ≥ 30°] was randomly allocated to two equal groups. Study design involved 7 minute massage given on each posterior thigh for 5 continuous days; followed by 5 days of no massage. Experimental group received classical Swedish massage whereas control group received only superficial stroking. Outcome measures were Passive straight leg raise [PSLR], Active knee extension test [AKET], Passive knee extension test [PKET], Back saver sit and reach test [BSSR] for flexibility and 5-0-5 change of direction test for agility measured pre and post intervention on each days of massage and also on 10th day. Two way ANOVA with post hoc t-test was the tool of statistical analysis with significance level 0.05.
RESULTS


Significant [p ≤ 0.05] post intervention increase in all parameters of flexibility was observed each day in experimental group within PSLR (8%-12% ↑), AKET (10%24% ↓) and PKET (12%-30% ↓) and highly significant (p ≤ 0.001) increase on 5th and 10th day in BSSR (4%-21% ↑) for both legs. Pre and post intervention values for control group were not significantly different. No significant changes were observed in agility performance of both groups.
CONCLUSION


Swedish massage of posterior thigh appears to acutely increase flexibility of hamstrings in female athletes, which persisted for 5 days even after cessation of massage.",2020,"RESULTS


Significant [p ≤ 0.05] post intervention increase in all parameters of flexibility was observed each day in experimental group within PSLR (8%-12% ↑), AKET (10%24% ↓) and PKET (12%-30% ↓) and highly significant (p ≤ 0.001) increase on 5th and 10th day in BSSR (4%-21% ↑) for both legs.","['female athletes', 'Arandom sample of 34 female players having bilateral tight hamstrings [passive straight leg raise ≤70° and active knee extension test\xa0≥', '30°', 'hamstring muscle and agility of female players']","['massage', 'Swedish massage', 'classical Swedish massage whereas control group received only superficial stroking']","['hamstring flexibility and agility of players', 'agility performance', 'flexibility', 'Passive straight leg raise [PSLR], Active knee extension test [AKET], Passive knee extension test [PKET], Back saver sit and reach test']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]",34.0,0.0330034,"RESULTS


Significant [p ≤ 0.05] post intervention increase in all parameters of flexibility was observed each day in experimental group within PSLR (8%-12% ↑), AKET (10%24% ↓) and PKET (12%-30% ↓) and highly significant (p ≤ 0.001) increase on 5th and 10th day in BSSR (4%-21% ↑) for both legs.","[{'ForeName': 'Kuljot', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Department of Physiotherapy, Punjabi University Patiala, Punjab, India. Electronic address: kuljotkaur7@gmail.com.'}, {'ForeName': 'A G K', 'Initials': 'AGK', 'LastName': 'Sinha', 'Affiliation': 'Department of Physiotherapy, Punjabi University Patiala, Punjab, India. Electronic address: Sinha2450007@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.029']
2713,33218557,Dissimilar perceptual response between trained women and men in resistance training to concentric failure: A quasi-experimental study.,"PURPOSE


This study compared sex-related affective responses during resistance training performed to concentric failure.
METHODS


The study was a non-randomized trial (quasi-experimental study). Well-trained young participants were allocated into two groups according to sex (Women, n = 7, 21.1 ± 6.0 years, 57.6 ± 5.0 kg; and Men, n = 7, 28.3 ± 5.7 years, 88.3 ± 11.4 kg). Participants visited the laboratory three times: 1) 12-repetition maximum; 2-3) resistance training to concentric failure sessions. Perceptual measures were assessed before, during, and immediately after the resistance training sessions. The following were assessed: a) rating of perceived exertion for effort (RPE-E) and discomfort (RPE-D), b) feeling scale, c) physical activity affect scale (PAAS), d) felt arousal scale, and e) physical activity enjoyment scale (PACES).
RESULTS


High levels of RPE-E and RPE-D were reported without between-groups differences (p > 0.218). Women reported a reduction in the feeling scale (p = 0.001) whereas men did not (p > 0.680). Larger effect sizes were observed for women compared to men in the felt arousal scale and PAAS (negative affect and fatigue). Feeling scale and felt arousal scale data plotted in a circumplex model of affect indicated a transition to high-activation and unpleasant-affect only for the women. There was good reliability between results from sessions 1 and 2.
CONCLUSIONS


Training to concentric failure resulted in negative changes in affective perceptual responses only for women. This type of training should be used with caution since it may change the affect perception and reduce training adherence in women. Further studies are needed using larger sample sizes, different resistance-training exercises, and diverse training methods.",2020,Larger effect sizes were observed for women compared to men in the felt arousal scale and PAAS (negative affect and fatigue).,"['trained women and men in resistance training to concentric failure', 'Well-trained young participants were allocated into two groups according to sex (Women, n\xa0=\xa07, 21.1\xa0±\xa06.0 years, 57.6\xa0±\xa05.0\xa0kg; and Men, n\xa0=\xa07, 28.3\xa0±\xa05.7 years, 88.3\xa0±\xa011.4\xa0kg', 'Participants visited the laboratory three times: 1) 12-repetition maximum; 2-3) resistance training to concentric failure sessions', 'women']",[],"['Feeling scale and felt arousal scale data', 'affective perceptual responses', 'RPE-E and RPE-D', 'feeling scale', 'rating of perceived exertion for effort (RPE-E) and discomfort (RPE-D), b) feeling scale, c) physical activity affect scale (PAAS), d) felt arousal scale, and e) physical activity enjoyment scale (PACES']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",[],"[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]",,0.0231324,Larger effect sizes were observed for women compared to men in the felt arousal scale and PAAS (negative affect and fatigue).,"[{'ForeName': 'Lucas B R', 'Initials': 'LBR', 'LastName': 'Orssatto', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, QLD, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diefenthaeler', 'Affiliation': 'Biomechanics Laboratory, Sports Center, Federal University of Santa Catarina, Florianópolis, SC, Brazil.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Vargas', 'Affiliation': 'Biomechanics Laboratory, Sports Center, Federal University of Santa Catarina, Florianópolis, SC, Brazil.'}, {'ForeName': 'Mateus', 'Initials': 'M', 'LastName': 'Rossato', 'Affiliation': 'Human Performance Laboratory, Faculty of Physical Education and Physiotherapy, Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Cíntia de la Rocha', 'Initials': 'CR', 'LastName': 'Freitas', 'Affiliation': 'Biomechanics Laboratory, Sports Center, Federal University of Santa Catarina, Florianópolis, SC, Brazil. Electronic address: cintia.freitas@ufsc.br.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.030']
2714,33220047,An Evaluation of Potential Unintended Consequences of a Nicotine Product Standard: A Focus on Drinking History and Outcomes.,"BACKGROUND


A nicotine product standard reducing the nicotine content in cigarettes could improve public health by reducing smoking. This study evaluated the potential unintended consequences of a reduced-nicotine product standard by examining its effects on (1) smoking behaviors based on drinking history; (2) drinking behavior; and (3) daily associations between smoking and drinking.
METHODS


Adults who smoke daily (n=752) in the United States were randomly assigned to smoke very low nicotine content (VLNC) versus normal nicotine content (NNC; control) cigarettes for 20 weeks. Linear mixed models determined if baseline drinking moderated the effects of VLNC versus NNC cigarettes on Week 20 smoking outcomes. Time-varying effect models estimated the daily association between smoking VLNC cigarettes and drinking outcomes.
RESULTS


Higher baseline alcohol use (versus no-use or lower use) was associated with a smaller effect of VLNC on Week 20 urinary total nicotine equivalents (ps<.05). No additional moderation was supported (ps>.05). In the subsample who drank (n=415), in the VLNC versus NNC condition, daily alcohol use was significantly reduced from Week 17-20 and odds of binge drinking were significantly reduced from Week 9-17. By Week 7 in the VLNC cigarette condition (n=272), smoking no longer predicted alcohol use but remained associated with binge drinking.
CONCLUSIONS


We did not support negative unintended consequences of a nicotine product standard. Nicotine reduction in cigarettes generally impacted smoking behavior for individuals who do not drink or drink light-to-moderate amounts in similar ways. Extended VLNC cigarette use may improve public health by reducing drinking behavior.
IMPLICATIONS


There was no evidence that a very low nicotine content product standard would result in unintended consequences based on drinking history or when considering alcohol outcomes. Specifically, we found that a very low nicotine standard in cigarettes generally reduces smoking outcomes for those who do not drink and those who drink light-to-moderate amounts. Furthermore, an added public health benefit of a very low nicotine standard for cigarettes could be a reduction in alcohol use and binge drinking over time. Finally, smoking very low nicotine content cigarettes may result in a decoupling of the daily associations between smoking and drinking.",2020,There was no evidence that a very low nicotine content product standard would result in unintended consequences based on drinking history or when considering alcohol outcomes.,['Adults who smoke daily (n=752) in the United States'],"['smoke very low nicotine content (VLNC) versus normal nicotine content (NNC; control) cigarettes', 'Nicotine Product Standard', 'Nicotine', 'VLNC']","['daily alcohol use', 'binge drinking', 'smoking outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.011735,There was no evidence that a very low nicotine content product standard would result in unintended consequences based on drinking history or when considering alcohol outcomes.,"[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Dermody', 'Affiliation': 'Ryerson University, Toronto, ON Canada.'}, {'ForeName': 'Katelyn M', 'Initials': 'KM', 'LastName': 'Tessier', 'Affiliation': 'University of MN, Minneapolis, MN.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'University of Wisconsin-Stevens Point.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': ""al'Absi"", 'Affiliation': 'University of MN, Minneapolis, MN.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Drobes', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'University of MN, Minneapolis, MN.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'University of MN, Minneapolis, MN.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Brown University, Providence, RI.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Donny', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Hatsukami', 'Affiliation': 'University of MN, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa236']
2715,33220069,Tacrolimus 0.03% ointment treatment in exfoliative cheilitis: a randomised controlled clinical trial and monitoring blood concentration.,"BACKGROUND


Tacrolimus has been used to treat various inflammatory skin diseases, but its safety for topical application on the oral mucosa is unknown. Exfoliative cheilitis (EC) is a chronic inflammatory disorder of the lips characterised by repeated scaling; it is difficult to manage. The aim of this study was to assess the efficacy and safety of tacrolimus 0.03% ointment as a topical treatment in patients with EC.
METHODS


In this randomised controlled clinical trial, 40 patients with EC were randomly assigned to receive either tacrolimus 0.03% ointment (experimental group, n = 20) or triamcinolone acetonide 0.1% cream (control group, n = 20) treatment for a 3-week period. Medication was administered in 3, 2, and 1 daily doses during the first, second, and third weeks, respectively. The patients with complete healing were followed up for 3 months. The clinical outcomes were measured, including the scores regarding signs (scale, dryness, rhagades, and swelling) and symptoms (rough, dry, pain, pruritus, and burning sensation) at every visit. Blood concentrations of tacrolimus were assessed.
RESULTS


After the 3-week treatment, healing rates of scale in the experimental and control groups were 65% and 10%, respectively (P = 0.018). Improvement in all signs and two symptoms (rough, pruritus) was much greater in the experimental group (P < 0.05). The 3-month recurrence rate was higher in the control group (P = 0.029). Tacrolimus blood concentrations were in the safe range (< 5 ng/mL).
CONCLUSION


Topical tacrolimus 0.03% ointment has good short-term efficacy and safety for treating EC.",2020,The 3-month recurrence rate was higher in the control group (P = 0.029).,"['exfoliative cheilitis', 'patients with EC', '40 patients with EC']","['triamcinolone acetonide 0.1% cream (control', 'Topical tacrolimus', 'tacrolimus 0.03% ointment', 'Tacrolimus', 'tacrolimus', 'Exfoliative cheilitis (EC']","['good short-term efficacy and safety', 'Blood concentrations of tacrolimus', '3-month recurrence rate', 'complete healing', 'efficacy and safety', 'scores regarding signs (scale, dryness, rhagades, and swelling) and symptoms (rough, dry, pain, pruritus, and burning sensation', 'Tacrolimus blood concentrations', 'healing rates of scale']","[{'cui': 'C0341058', 'cui_str': 'Exfoliative cheilitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0358003', 'cui_str': 'Triamcinolone acetonide 1 mg/mL cutaneous cream'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0939241', 'cui_str': 'Tacrolimus-containing product in cutaneous dose form'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0341058', 'cui_str': 'Exfoliative cheilitis'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0221245', 'cui_str': 'Fissure in skin'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}]",40.0,0.0747555,The 3-month recurrence rate was higher in the control group (P = 0.029).,"[{'ForeName': 'Junjiang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Xiangjian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Fanglong', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Mingjia', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, 610041, P.R. China.'}]",Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology,['10.1111/jop.13142']
2716,33220090,The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height ≤ 6mm: A two-year prospective randomized study.,"OBJECTIVES


To compare clinical and radiographic outcomes between transcrestal sinus floor elevation (TSFE) and lateral sinus floor elevation (LSFE) approaches of simultaneous implant placement in atrophic maxilla.
MATERIALS AND METHODS


Patients with a residual bone height (RBH) ≤6 mm were enrolled and randomly assigned to TSFE and LSFE groups. Patients in both groups simultaneously underwent sinus floor elevation with bovine-derived xenograft and implant placement. Clinical and radiographic results were evaluated immediately after surgery and after 6, 12, 18, and 24 months. The endo-sinus bone gain (ESBG), apical implant bone height (ABH), endo-sinus bone-implant contact rate (EBICR), and crestal bone level (CBL) were assessed using panoramic radiographs.
RESULTS


Forty-one implants (TSFE: 21, LSFE: 20) were placed in cases with a mean RBH of 3.77 ±1.16 mm. All implants obtained clinical success and satisfactory ESBG at 24 months. No significant differences were found in ESBG and ABH between two groups immediately after surgery, but LSFE group showed significantly higher values than TSFE group thereafter. Grafts in TSFE group reached stability 6 months earlier than that in LSFE group. In both groups, EBICR was almost 100%, and CBL showed no detectable changes.
CONCLUSIONS


LSFE can achieve higher ESBG 2 years after surgery. Otherwise, TSFE could be an alternative to LSFE, when the access for lateral window preparation is limited. Both approaches were highly predictable for RBH ≤6 mm during 24-month observation period for the implants placed simultaneously.",2020,"No significant differences were found in ESBG and ABH between two groups immediately after surgery, but LSFE group showed significantly higher values than TSFE group thereafter.","['Patients with a residual bone height (RBH) ≤6 mm', 'sites with residual bone height ≤ 6mm']","['transcrestal and lateral sinus floor elevation', 'TSFE and LSFE', 'transcrestal sinus floor elevation (TSFE) and lateral sinus floor elevation (LSFE', 'TSFE', 'LSFE', 'bovine-derived xenograft and implant placement']","['endo-sinus bone gain (ESBG), apical implant bone height (ABH), endo-sinus bone-implant contact rate (EBICR), and crestal bone level (CBL', 'EBICR', 'ESBG and ABH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0226864', 'cui_str': 'Structure of transverse sinus'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0208141,"No significant differences were found in ESBG and ABH between two groups immediately after surgery, but LSFE group showed significantly higher values than TSFE group thereafter.","[{'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Implantology, the Affiliated Stomatology Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Hangzhou, Zhejiang, 310000, China.'}, {'ForeName': 'Misi', 'Initials': 'M', 'LastName': 'Si', 'Affiliation': 'Department of Implantology, the Affiliated Stomatology Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China.'}, {'ForeName': 'Mengjie', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Hangzhou, Zhejiang, 310000, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Key Laboratory of Oral Biomedical Research of Zhejiang Province, Hangzhou, Zhejiang, 310000, China.'}]",Clinical oral implants research,['10.1111/clr.13688']
2717,33218548,The effect of quadriceps kinesiotaping on the dynamic balance of young healthy women after fatigue: A randomized controlled trial.,"BACKGROUND


Balance is a key factor in performing daily activities and the quadriceps muscle plays an important role in regaining balance following imbalance. Quadriceps fatigue may cause disruption in sending proprioception signals to the central nervous system and may, ultimately, lead to motor dysfunction and increased fluctuating dynamic and static balance which is followed by an increased risk of falling. Based on conclusions from previous studies it is proposed that kinesiotaping (KT) might be effective in the reduction of muscle fatigue and eventually balance.
OBJECTIVE


To investigate the effect of quadriceps KT on the dynamic balance of young healthy non-athlete women following local fatigue.
DESIGN


A Single-blind parallel randomized clinical trial.
METHOD


28 healthy women aged from 18 to 30 years were selected using the convenience sampling method. They were thoroughly evaluated with regard to the inclusion and exclusion criteria and randomly divided into two groups of kinesiotaping (n = 14) and non-tape (n = 14) using coin tossing. Balance measurement was performed on both groups before and after fatigue using the Y balance test. Both groups performed the fatigue protocol, but only the KT group was taped.
RESULTS


Results demonstrated that, the mean of normalized reach distances at anterior (KT: 1.014 ± 0.073, non-tape: 0.964 ± 0.097), posteromedial (KT: 0.816 ± 0.125, non-tape: 0.809 ± 0.076) and posterolateral (KT: 0.794 ± 0.102, non-tape: 0.753 ± 0.093) directions in the Y balance test had no significant difference between both groups after fatigue (p > 0.05).
CONCLUSION


Our findings indicated no significant effect of quadriceps KT on the dynamic balance of young healthy women after fatigue.",2020,"To investigate the effect of quadriceps KT on the dynamic balance of young healthy non-athlete women following local fatigue.
","['young healthy women after fatigue', 'young healthy non-athlete women following local fatigue', '28 healthy women aged from 18 to 30 years were selected using the convenience sampling method']","['quadriceps kinesiotaping', 'quadriceps KT', 'kinesiotaping (n\u202f=\u202f14) and non-tape (n\u202f=\u202f14) using coin tossing']",['mean of normalized reach distances'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}]","[{'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0524669', 'cui_str': 'Coins'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",28.0,0.0321401,"To investigate the effect of quadriceps KT on the dynamic balance of young healthy non-athlete women following local fatigue.
","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Esfandiari', 'Affiliation': 'Musculoskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Javid', 'Initials': 'J', 'LastName': 'Mostamand', 'Affiliation': 'Musculoskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: mostamand@rehab.mui.ac.ir.'}, {'ForeName': 'Hamzeh', 'Initials': 'H', 'LastName': 'Baharlouei', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.036']
2718,33218551,Feasibility and preliminary efficacy of a hypopressive exercise program on postmenopausal cancer survivors: A pilot study.,"BACKGROUND


Cancer-related fatigue (CRF) is a common symptom during and after cancer treatment that negatively affects the patient's quality of life. Exercise is one of the most effective non-pharmacological treatments for CRF. Multimodal exercise therapy programs that include hypopressive exercises, relaxation and myofascial release may be beneficial for CRF. The aim of this pilot study was to evaluate the feasibility and efficacy of a multimodal program on CRF and lower limb functional strength in postmenopausal women diagnosed with cancer.
METHODS


7 postmenopausal women (age = 55.28 years; BMI = 26.05 kg/m2) who had a cancer diagnosis participated in a supervised and progressive 55-min class once per week for 12-weeks. CRF was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer Related Fatigue 12 and lower limb strength was assessed with the sit and stand test.
RESULTS


No adverse events were reported during the training period and all participants completed the exercise protocol. There was a significant increase (p = 0.01) in lower limb functional strength (pre: 19.60 (SD = 2.19) vs post: 24.60(SD = 2.19)) with an effect size of d = 2.28 and a decrease in CRF (p = 0.245) (pre: 29.36 ± 24.42; post: 17.85 ± 14.23) with a trivial effect size (d < 0.5).
CONCLUSIONS


These preliminary findings indicate that a supervised once per week multimodal program that includes hypopressive exercises for postmenopausal cancer survivors increased lower limb functional strength without exacerbating their CRF. These findings support further randomized trials of hypopressive training programs on patients with cancer.",2020,There was a significant increase (p = 0.01) in lower limb functional strength (pre: 19.60 (SD = 2.19),"['postmenopausal cancer survivors', '7 postmenopausal women (age\xa0=\xa055.28 years; BMI\xa0=\xa026.05\xa0kg/m2) who had a cancer diagnosis participated in a supervised and progressive 55-min class once per week for 12-weeks', 'postmenopausal women diagnosed with cancer', 'patients with cancer']","['Multimodal exercise therapy programs', 'hypopressive training programs', 'hypopressive exercise program', 'multimodal program']","['hypopressive exercises, relaxation and myofascial release', 'CRF', 'lower limb functional strength', 'trivial effect size ', 'Cancer Quality of Life Questionnaire-Cancer Related Fatigue 12 and lower limb strength', 'adverse events', 'feasibility and efficacy', 'limb functional strength']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",7.0,0.0355288,There was a significant increase (p = 0.01) in lower limb functional strength (pre: 19.60 (SD = 2.19),"[{'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Chulvi-Medrano', 'Affiliation': 'Physical Education and Sports Department, UIRFIDE (Sport Performance and Physical Fitness Research Group), University of Valencia, C/ Gascó Oliag, nº3.46010, Valencia, Spain. Electronic address: ivan.chulvi@uv.es.'}, {'ForeName': 'Tamara Rial', 'Initials': 'TR', 'LastName': 'Rebullido', 'Affiliation': 'International Hypopressive and Physical Therapy Institute, Vigo, Spain.'}, {'ForeName': 'Cinta', 'Initials': 'C', 'LastName': 'Gómez-Tomás', 'Affiliation': 'Department of Physiotherapy, Catholic University of Murcia, Murcia, Spain.'}, {'ForeName': 'Avery D', 'Initials': 'AD', 'LastName': 'Faigenbaum', 'Affiliation': 'Department of Health and Exercise Science, The College of New Jersey, Ewing, NJ, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.019']
2719,33218552,Effects of exercise mode in knee cartilage thickness.,"BACKGROUND


It is unclear how cycling and running would differ in terms of changes in cartilage thickness. Also, given squats are a popular type of exercise used to strengthen lower limbs, it is critical to assess if loads used during resisted training could lead to changes in cartilage cushioning properties. Therefore, the purpose of this study was to compare the effects of exercise mode in knee cartilage thickness.
METHODS


This study utilized a randomized cross-over design with repeated measures. All sessions were completed between 48hrs and seven days, at the same time of the day. Fourteen (seven males and seven females) apparently healthy participants without musculoskeletal or neurological diseases volunteered for the study. Participants were assessed after squats and functional exercises (n = 18 knees) or after running and cycling (n = 10 knees). All ultrasound images were collected at participants' arrival in the laboratory (Baseline), after warm-up (Pre-exercise), after the completion of each exercise protocol (Post-exercise), and at five (5-min) and 10 minutes (10-min) after exercise.
RESULTS


Cartilage thickness did not change after squats performed with 60% of 1-RM or after a set of three functional exercises (i.e. sit-to-stand, lunges, and step-ups; p = 0.68). However, longer duration exercises (i.e. cycling and running) led to increases in cartilage thickness after 5-min from the completion of the exercise (p = 0.02).
CONCLUSION


Knee cartilage may have capacity to sustain short-term cyclical loads applied during exercise (i.e. squats and functional exercises) but not to moderate duration exercises (i.e. cycling and running).",2020,"RESULTS


Cartilage thickness did not change after squats performed with 60% of 1-RM or after a set of three functional exercises (i.e. sit-to-stand, lunges, and step-ups; p = 0.68).","['knee cartilage thickness', 'apparently healthy participants without musculoskeletal or neurological diseases volunteered for the study', 'Fourteen (seven males and seven females']",[],"['cartilage thickness', 'Cartilage thickness', 'longer duration exercises']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0480389,"RESULTS


Cartilage thickness did not change after squats performed with 60% of 1-RM or after a set of three functional exercises (i.e. sit-to-stand, lunges, and step-ups; p = 0.68).","[{'ForeName': 'Rodrigo Rico', 'Initials': 'RR', 'LastName': 'Bini', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, Bendigo, Australia. Electronic address: r.bini@latrobe.edu.au.'}, {'ForeName': 'Alice Flores', 'Initials': 'AF', 'LastName': 'Bini', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, Bendigo, Australia.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.05.006']
2720,33218559,Effects of kinesiotaping combined with the motor relearning method on upper limb motor function in adults with hemiparesis after stroke.,"INTRODUCTION


Kinesio Taping (KT) is being widely used in neurorehabilitation as an adjuvant technique due to its therapeutic effects. The objective of this study was to determine the effects of Kinesio Taping combined with the motor relearning method on upper limb motor function in adult patients with post-stroke hemiparesis.
METHODS


A quasi-experimental study with pre-test and post-test in a sample of 10 adult patients with post-stroke hemiparesis, randomly assigned in two groups: experimental (n: 5) who received 12 sessions of Kinesio Taping combined with the motor relearning method and a control group (n: 5) who only received 12 sessions of the motor relearning method. Motor function was assessed through the selective movement pattern scale for adult patients with upper motor neuron injury before and after each intervention.
RESULTS


statistically significant differences (p < 0.05) were found when comparing the means of upper limb movement patterns of the experimental group.
CONCLUSIONS


the use of Kinesio Taping combined with the motor relearning method was encouraging for upper limb motor function in patients with spastic hemiparesis.",2020,"Motor function was assessed through the selective movement pattern scale for adult patients with upper motor neuron injury before and after each intervention.
","['adult patients with post-stroke hemiparesis', 'adult patients with upper motor neuron injury before and after each intervention', '10 adult patients with post-stroke hemiparesis', 'patients with spastic hemiparesis', 'adults with hemiparesis after stroke']","['Kinesio Taping combined with the motor relearning method', 'kinesiotaping combined with the motor relearning method', 'Kinesio Taping combined with the motor relearning method and a control group (n: 5) who only received 12 sessions of the motor relearning method', 'Kinesio Taping (KT']","['upper limb motor function', 'Motor function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0524458', 'cui_str': 'Upper motor neuron'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0154694', 'cui_str': 'Spastic hemiplegia'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",10.0,0.0338269,"Motor function was assessed through the selective movement pattern scale for adult patients with upper motor neuron injury before and after each intervention.
","[{'ForeName': 'Piedad Rocío', 'Initials': 'PR', 'LastName': 'Lerma Castaño', 'Affiliation': 'Physiotherapist, Master in neurorehabilitation. Fundación Universitaria María Cano- Sede, Neiva, Colombia. Electronic address: piedadrociolermacastano@fumc.edu.co.'}, {'ForeName': 'Yasmin Andrea', 'Initials': 'YA', 'LastName': 'Rodríguez Laiseca', 'Affiliation': 'Physiotherapist, Integrated Management systems, Fundación Universitaria María Cano- Sede Neiva, Colombia.'}, {'ForeName': 'Diana Paola', 'Initials': 'DP', 'LastName': 'Montealegre Suárez', 'Affiliation': 'Physiotherapist, Comprehensive intervention in the athlete. Fundación Universitaria María Cano - Sede Neiva, Colombia.'}, {'ForeName': 'Danna Brigitte', 'Initials': 'DB', 'LastName': 'Castrillón Papamija', 'Affiliation': 'Physiotherapist. IPS Salud Vital, Colombia.'}, {'ForeName': 'Gladys Estefany', 'Initials': 'GE', 'LastName': 'Losada Urriago', 'Affiliation': 'Physiotherapist. Clínica Belo Horizonte, Colombia.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.07.003']
2721,33218560,"Muscle excitation, force response, and efficiency during explosive force production after diacutaneous fibrolysis on lateral gastrocnemius of recreational athletes.","OBJECTIVE


Fibrous adhesions impair normal muscle mechanics. The present study aimed to assess lateral gastrocnemius muscle excitation, isometric force response, and neuromuscular efficiency during explosive force in plantarflexion before and after diacutaneous fibrolysis.
METHODS


Thirty-five recreational athletes were allocated in the intervention group (n = 20) treated with diacutaneous fibrolysis, while the sham group (n = 15) was treated with placebo diacutaneous fibrolysis. Force response synchronized with surface electromyography during a plantarflexion task was collected.
RESULTS


Differences between Pre- and Post-diacutaneous fibrolysis were observed for all variables, except for the placebo group.
CONCLUSIONS


Diacutaneous fibrolysis was effective to increase force, muscle excitation, and neuromuscular efficiency on lateral gastrocnemius.",2020,"-diacutaneous fibrolysis were observed for all variables, except for the placebo group.
","['Thirty-five recreational athletes', 'recreational athletes']","['placebo diacutaneous fibrolysis', 'diacutaneous fibrolysis']","['force, muscle excitation, and neuromuscular efficiency on lateral gastrocnemius', 'lateral gastrocnemius muscle excitation, isometric force response, and neuromuscular efficiency', 'diacutaneous fibrolysis', 'Muscle excitation, force response, and efficiency']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}]",35.0,0.038187,"-diacutaneous fibrolysis were observed for all variables, except for the placebo group.
","[{'ForeName': 'William Bezerra', 'Initials': 'WB', 'LastName': 'Leite', 'Affiliation': 'Musculoskeletal Research Group, Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lima de Oliveira', 'Affiliation': 'Musculoskeletal Research Group, Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil; Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil.'}, {'ForeName': 'Michelle Almeida', 'Initials': 'MA', 'LastName': 'Barbosa', 'Affiliation': 'Musculoskeletal Research Group, Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil.'}, {'ForeName': 'Isabella Christina', 'Initials': 'IC', 'LastName': 'Ferreira', 'Affiliation': 'Musculoskeletal Research Group, Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil; Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Mesquita', 'Affiliation': 'Dinâmica College Vale do Piranga/FADIP, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Baumgarth', 'Affiliation': 'Department of Biological Sciences & Health, University Veiga de Almeida, Brazil.'}, {'ForeName': 'Alexandre Carvalho', 'Initials': 'AC', 'LastName': 'Barbosa', 'Affiliation': 'Musculoskeletal Research Group, Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil; Department of Physical Therapy, Federal University of Juiz de Fora, Campus Governador Valadares, Brazil. Electronic address: alexwbarbosa@hotmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.08.001']
2722,33218561,Effects of proprioceptive neuromuscular facilitation stretching at low-intensities with standing toe touch on developing and maintaining hamstring flexibility.,"BACKGROUND


Proprioceptive neuromuscular facilitation (PNF) stretching at low intensities has been rarely investigated. Previous studies have shown that hamstring flexibility after stretching is only temporary.
OBJECTIVE


The aim of this study was to assess the effect of low intensities (40% and 10% of maximum voluntary isometric contraction, MVIC) of PNF stretching on hamstring muscles and to assess the effect of standing toe touch on the duration of hamstring flexibility.
METHODS


This was a single-blind randomized controlled trial. Sixty-four healthy adults (age, 22.67 ± 1.73 years) were selected and divided into four groups: 40% intensity PNF stretching (P40), 10% intensity PNF stretching (P10), 40% intensity PNF stretching with toe touch (P40 with TT), and 10% intensity PNF stretching with toe touch (P10 with TT). Hamstring flexibility was measured using the active knee extension test (pre-stretching, post-stretching, and 3, 6, 9, 12, and 15 min after PNF stretching).
RESULTS


In the P40, P40 with TT, and P10 with TT groups, significant changes were observed at all time points after stretching (p < 0.05). In the P10 group, significant changes were only observed immediately post stretching (p = 0.006) and at 3 min (p = 0.029) after stretching. In terms of maintaining the duration of flexibility, the P40 with TT and P10 with TT groups were superior to the P40 and P10 groups.
CONCLUSION


PNF stretching at low intensity, approaching 40% of MVIC, led to more flexibility than 10% MVIC. Additionally, standing toe touch after PNF stretching is recommended to develop and maintain hamstring flexibility.",2020,"In the P10 group, significant changes were only observed immediately post stretching (p = 0.006) and at 3 min (p = 0.029) after stretching.","['Sixty-four healthy adults (age, 22.67\xa0±\xa01.73 years']","['proprioceptive neuromuscular facilitation stretching', 'PNF stretching', '40% intensity PNF stretching (P40), 10% intensity PNF stretching (P10), 40% intensity PNF stretching with toe touch (P40 with TT), and 10% intensity PNF stretching with toe touch (P10 with TT']","['hamstring flexibility', 'Hamstring flexibility']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1720874', 'cui_str': 'Proprioceptive Neuromuscular Facilitation (PNF) Stretching'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0079407', 'cui_str': 'Gene Product, tax'}, {'cui': 'C0966870', 'cui_str': 'S100 calcium binding protein A10'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",64.0,0.0751106,"In the P10 group, significant changes were only observed immediately post stretching (p = 0.006) and at 3 min (p = 0.029) after stretching.","[{'ForeName': 'Sieun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Health and Welfare, Woosong University, Daejeon, Republic of Korea; Woosong Institute of Rehabilitation Science, Woosong University, Daejeon, Republic of Korea.'}, {'ForeName': 'Wootaek', 'Initials': 'W', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, College of Health and Welfare, Woosong University, Daejeon, Republic of Korea; Woosong Institute of Rehabilitation Science, Woosong University, Daejeon, Republic of Korea. Electronic address: wootaeklimpt@wsu.ac.kr.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.08.003']
2723,33218563,Intra tester reliability of sympathetic skin responses in subjects with primary palmar hyperhidrosis.,"BACKGROUND


Primary palmar hyperhidrosis (PPH) is a disorder related to sympathetic dysfunction. Iontophoresis can be used to reduce sweating rate. Sympathetic skin response (SSR) is commonly used to evaluate the sympathetic system. However, scarce evidence exists about the reliability of SSR parameters.
OBJECTIVE


To assess the relative and absolute reliability of SSR before and after the application of iontophoresis with aluminum chloride hexahydrate (ACH) gel or tap water in subjects with PPH.
METHODS


Twenty subjects were randomized to receive either iontophoresis with ACH gel or tap water. Three SSRs (amplitude and latency) with 5 s intervals from both hands in both groups were recorded before and after the application of iontophoresis for 30 min. Reliability of amplitude and latency of the SSR was assessed using intraclass correlation coefficient (ICC) with 95% confidence intervals, standard error of measurement (SEM), and minimal detectable change (MDC).
RESULTS


Amplitudes and latencies of SSR showed good to excellent test-retest reliability for ICC in both groups before iontophoresis. Except for right hand latency which was moderate (0.5-0.75). After iontophoresis, the ACH gel group still showed good to excellent agreement for SSR parameters, while the reliability of SSR parameters in the tap water group was reduced.
CONCLUSION


Subjects with PPH showed high intra-rater reliability for SSR parameters which was maintained after ACH gel iontophoresis and decreased after tap water iontophoresis. It seems that media used for iontophoresis or the state of media (gel vs liquid) may affect the reliability of SSR. Further research is recommended.",2020,"RESULTS


Amplitudes and latencies of SSR showed good to excellent test-retest reliability for ICC in both groups before iontophoresis.","['Twenty subjects', 'subjects with PPH', 'subjects with primary palmar hyperhidrosis']","['Sympathetic skin response (SSR', 'aluminum chloride hexahydrate (ACH) gel', 'iontophoresis with ACH gel or tap water', 'ACH gel']","['standard error of measurement (SEM), and minimal detectable change (MDC', 'high intra-rater reliability', 'Reliability of amplitude and latency of the SSR', 'SSR parameters', 'reliability of SSR parameters', 'sweating rate']","[{'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C1274743', 'cui_str': 'Palmoplantar hyperhidrosis'}]","[{'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C2919405', 'cui_str': 'Tap water'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}]",20.0,0.019009,"RESULTS


Amplitudes and latencies of SSR showed good to excellent test-retest reliability for ICC in both groups before iontophoresis.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ghandali', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Majid', 'Initials': 'SM', 'LastName': 'Hosseini', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Majid_hoseini@sbmu.ac.ir.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Moghimi', 'Affiliation': 'Department of Pharmaceutics and Nanotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Khosro', 'Initials': 'K', 'LastName': 'Khademi-Kalantari', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Talebian Moghadam', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza Akbarzadeh', 'Initials': 'AA', 'LastName': 'Baghban', 'Affiliation': 'Proteomics Research Center, Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh Maryam', 'Initials': 'SM', 'LastName': 'Mortazavi', 'Affiliation': 'Department of Pharmaceutics and Nanotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.024']
2724,33218566,The effects of Pilates training on static and dynamic balance of female deaf students: A randomized controlled trial.,"INTRODUCTION


To evaluate the effect of Pilates training on static and dynamic balance of deaf female.
METHODS


This study is a randomized, controlled trial with concealed randomization and blinded assessments. 19 female deaf students participated in this study and were randomly assigned into experimental (EXP, n = 9) and control (CON, n = 10) groups. Static balance was examined by Balance Error Scoring System (BESS), and dynamic balance was examined by Y balance test (YBT). The experimental group performed a Pilates training program for 8 weeks (three sessions of 60 min).
RESULTS


The findings showed that experimental group showed a significant change in static balance (with open eye and close eye) and dynamic balance (dominant limb and non-dominant limb) after 8 weeks Pilates training (p < 0.05). The control also showed no significant changes after training duration (p > 0.05).
CONCLUSIONS


This study showed that Pilates training significantly improve balance in female deaf students.",2020,The findings showed that experimental group showed a significant change in static balance (with open eye and close eye) and dynamic balance (dominant limb and non-dominant limb) after 8 weeks Pilates training (p < 0.05).,"['female deaf students', '19 female deaf students']","['Pilates training program', 'Pilates training']","['Balance Error Scoring System (BESS), and dynamic balance', 'Static balance', 'static balance (with open eye and close eye) and dynamic balance (dominant limb and non-dominant limb']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]",,0.01946,The findings showed that experimental group showed a significant change in static balance (with open eye and close eye) and dynamic balance (dominant limb and non-dominant limb) after 8 weeks Pilates training (p < 0.05).,"[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Zarei', 'Affiliation': 'Physical Education & Sport Sciences, (corrective Exercise and Sport Injuries), Corrective Exercises and Sports Injury Department, Faculty of Physical Education & Sport Sciences, University of Guilan, Rasht, Postcode No. 4199613776, Iran. Electronic address: Zareei.h@yahoo.com.'}, {'ForeName': 'Ali Asghar', 'Initials': 'AA', 'LastName': 'Norasteh', 'Affiliation': 'Physical Education & Sport Sciences, (corrective Exercise and Sport Injuries), Corrective Exercises and Sports Injury Department, Faculty of Physical Education & Sport Sciences, University of Guilan, Rasht, Postcode No. 4199613776, Iran. Electronic address: Asgharnorasteh@yahoo.com.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Rahmanpournashrudkoli', 'Affiliation': 'Physical Education & Sport Sciences, (corrective Exercise and Sport Injuries), Corrective Exercises and Sports Injury Department, Faculty of Physical Education & Sport Sciences, University of Guilan, Rasht, Postcode No. 4199613776, Iran. Electronic address: Rahmanpoor.akram@gmail.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hajihoseini', 'Affiliation': 'Physical Education & Sport Sciences, (corrective Exercise and Sport Injuries), Corrective Exercises and Sports Injury Department, Faculty of Physical Education & Sport Sciences, University of Guilan, Rasht, Postcode No. 4199613776, Iran. Electronic address: Hosseinielham1988@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.05.003']
2725,33218747,Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial.,"Many Veterans of the 1990-1991 Gulf War report symptoms of Gulf War Illness, a condition involving numerous chronic symptoms including pain, fatigue, and mood/cognition symptoms. Little is known about this condition's etiology and treatment. This study reports outcomes from a randomized controlled single-blind trial comparing yoga to cognitive behavioral therapy for chronic pain and other symptoms of Gulf War Illness. Participants were Veterans with symptoms of GWI: chronic pain, fatigue and cognition-mood symptoms. Seventy-five Veterans were randomized to treatment via selection of envelopes from a bag (39 yoga, 36 cognitive behavioral therapy), which consisted of ten weekly group sessions. The primary outcomes of pain severity and interference (Brief Pain Inventory- Short Form) improved in the yoga condition (Cohen's d = .35, p = 0.002 and d = 0.69, p < 0.001, respectively) but not in the CBT condition (d = 0.10, p = 0.59 and d = 0.25 p = 0.23). However, the differences between groups were not statistically significant (d = 0.25, p = 0.25; d = 0.43, p = 0.076), though the difference in an a-priori-defined experimental outcome variable which combines these two variables into a total pain variable (d = 0.47, p = 0.047) was significant. Fatigue, as indicated by a measure of functional exercise capacity (6-min walk test) was reduced significantly more in the yoga group than in the CBT group (between-group d = .27, p = 0.044). Other secondary outcomes of depression, wellbeing, and self-reported autonomic nervous system symptoms did not differ between groups. No adverse events due to treatment were reported. Yoga may be an effective treatment for core Gulf War Illness symptoms of pain and fatigue, making it one of few treatments with empirical support for GWI. Results support further evaluation of yoga for treating veterans with Gulf War Illness. CLINICAL TRIAL REGISTRY: clinicaltrials.gov Registration Number NCT02378025.",2020,"Fatigue, as indicated by a measure of functional exercise capacity (6-min walk test) was reduced significantly more in the yoga group than in the CBT group (between-group d = .27, p = 0.044).","['chronic pain and other symptoms of Gulf War Illness', 'Participants were Veterans with symptoms of GWI: chronic pain, fatigue and cognition-mood symptoms', 'Seventy-five Veterans', 'Many Veterans of the 1990-1991 Gulf War report symptoms of Gulf War Illness, a condition involving numerous chronic symptoms including pain, fatigue, and mood/cognition symptoms', 'veterans with Gulf War Illness']","['CBT', 'yoga to cognitive behavioral therapy']","['depression, wellbeing, and self-reported autonomic nervous system symptoms', 'total pain variable', 'pain severity and interference (Brief Pain Inventory- Short Form) improved in the yoga condition', 'adverse events', 'Fatigue', 'functional exercise capacity (6-min walk test']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1449761', 'cui_str': 'Persian Gulf War, 1991'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",,0.156941,"Fatigue, as indicated by a measure of functional exercise capacity (6-min walk test) was reduced significantly more in the yoga group than in the CBT group (between-group d = .27, p = 0.044).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Bayley', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA. Electronic address: peter.bayley@va.gov.'}, {'ForeName': 'R Jay', 'Initials': 'RJ', 'LastName': 'Schulz-Heik', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Cho', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mathersul', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collery', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Kamala', 'Initials': 'K', 'LastName': 'Shankar', 'Affiliation': 'VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'J Wesson', 'Initials': 'JW', 'LastName': 'Ashford', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Jennings', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Avery', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Michael Vicente', 'Initials': 'MV', 'LastName': 'Stanton', 'Affiliation': 'California State University, East Bay, Hayward, CA, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Meyer', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Palo Alto University, Palo Alto, CA, USA.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Friedman', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA; Palo Alto University, Palo Alto, CA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jarred', 'Initials': 'J', 'LastName': 'Younger', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Binil', 'Initials': 'B', 'LastName': 'Mathews', 'Affiliation': 'VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Matra', 'Initials': 'M', 'LastName': 'Majmundar', 'Affiliation': 'International Association of Yoga Therapists, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mahoney', 'Affiliation': 'War Related Illness and Injury Study Center, VA Palo Alto Healthcare System, Palo Alto, CA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.11.024']
2726,33218824,"Reply to Amit Bansal, Ruchir Maheshwari, and Anant Kumar's Letter to the Editor re: Beatriz Goulao, Sonya Carnell, Jing Shen, et al. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial). Eur Urol 2020;78:572-80.",,2020,,['Recurrent Bulbar Urethral Stricture'],['Open Urethroplasty Versus Endoscopic Urethrotomy'],[],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0194550', 'cui_str': 'Incision of urethra'}]",[],,0.0162908,,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. Electronic address: luke.vale@newcastle.ac.uk.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Centre for Healthcare and Randomised Trials, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Watkin', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}]",European urology,['10.1016/j.eururo.2020.10.021']
2727,33218847,Sociodemographic and Psychosocial Factors Associated with Diet Quality in 6 Rural Native American Communities.,"OBJECTIVE


To identify psychosocial and household environmental factors related to diet quality among Native Americans (NA).
DESIGN


Analysis of baseline data from a community-randomized obesity prevention trial.
SETTING


Six rural NA communities in the Midwest and the Southwestern US.
PARTICIPANTS


A total of 580 tribal members, aged 18-75 years old (mean 45 years), 74% female, self-identified as the main household food purchaser.
VARIABLES MEASURED


Diet quality (Healthy Eating Index-2015 [HEI]) was derived from a semiquantitative food frequency questionnaire. Sociodemographic, psychosocial, and home food environment factors were assessed via interviewer-administered questionnaires.
ANALYSIS


One-way ANOVA, linear regression models, and 2-tailed t tests compared HEI scores among sociodemographic categories. Multiple linear regression models assessed the relationship between psychosocial factors, home food environment, and HEI.
RESULTS


Prevalence of obesity was 59%. Mean HEI-2015 score was 49.3 (SD = 8.1). Average HEI scores were 3.0 points lower in smokers than nonsmokers (P < .001), and 2.2 points higher in females than males (P < .01). Higher self-efficacy (β = 0.97; P < .001) and healthier eating intentions (β = 0.78; P < .001) were positively associated with HEI. Healthier household food patterns score was associated with higher HEI (β = 0.48; P < .01).
CONCLUSIONS AND IMPLICATIONS


Psychosocial factors were associated with diet quality, a finding that supports the use of social-cognitive intervention approaches in rural NA communities in the Midwest and Southwest, and warrants evaluation in other locations. There remains a need to elucidate the association between the Food Distribution Program on Indian Reservations and diet quality.",2020,"Healthier household food patterns score was associated with higher HEI (β = 0.48; P < .01).
","['Native Americans (NA', '6 Rural Native American Communities', 'Six rural NA communities in the Midwest and the Southwestern US', 'A total of 580 tribal members, aged 18-75 years old (mean 45 years), 74% female, self-identified as the main household food purchaser']",[],"['Higher self-efficacy', 'Sociodemographic, psychosocial, and home food environment factors', 'Healthier household food patterns score', 'Average HEI scores', 'Prevalence of obesity', 'Diet quality (Healthy Eating Index-2015 [HEI', 'Mean HEI-2015 score', 'healthier eating intentions']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",580.0,0.0270613,"Healthier household food patterns score was associated with higher HEI (β = 0.48; P < .01).
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Estradé', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. Electronic address: mestrad7@jhu.edu.'}, {'ForeName': 'Angela C B', 'Initials': 'ACB', 'LastName': 'Trude', 'Affiliation': 'Department of Pediatrics, University of Maryland, College Park, MD.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Pardilla', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Brittany Wenniserí Iostha', 'Initials': 'BWI', 'LastName': 'Jock', 'Affiliation': ""School of Human Nutrition, Centre for Indigenous Peoples' Nutrition and Environment (CINE), McGill University, Ste-Anne-de-Bellevue, Quebec, Canada.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Swartz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gittelsohn', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.05.001']
2728,33218863,Talectomy for the Management of Resistant Talipes Equinovarus Deformity; Does Adding Ilizarov External Fixator Provide Extra Advantages?,"BACKGROUND


The management of resistant talipes equinovarus (TEV) is challenging. Residual deformity and recurrence are among the most feared complications. This study was conducted to evaluate the effectiveness of talectomy in the management of arthrogrypotic TEV and to investigate the value of adding a simplified Ilizarov fixator (SIF).
PATIENTS AND METHODS


A total of 42 resistant TEV feet among 23 arthrogrypotic children were operated between January 2012 and 2016. The average age was 6.7 ± 1.67 years. The feet were divided into 2 groups; group A (Casting group) included 20 feet (11 children) that were managed by talectomy and casting, while group B (Fixator group) included 22 feet (12 children) that were treated using a SIF concomitant with talectomy. The results were evaluated morphologically by Dimeglio grading system and functionally by Legaspi system.
RESULTS


The average follow-up was 36.62 ± 3.88 months. With the numbers available in this study, there was significant improvement (p ≤ .05) in the Dimeglio scores in both groups, which was significantly more evident (p ≤ .05) among the fixator group. The majority of the good functional results were reported among the fixator group, while the poor feet were observed mainly in the casting group (p ≤ .05). The functional end results were significantly affected (p≤ .05) by the final Dimeglio scores. The age had also statistically significant effect (p≤ .05) on the functional end results in group A only.
CONCLUSION


Talectomy is an effective procedure for salvaging arthrogrypotic TEV. Supplementation of the procedure by SIF was associated with more satisfactory morphological and functional results particularly in older children.",2020,"With the numbers available in this study, there was significant improvement (p ≤ .05) in the Dimeglio scores in both groups, which was significantly more evident (p ≤ .05) among the fixator group.","['23 arthrogrypotic children were operated between January 2012 and 2016', 'Resistant Talipes Equinovarus Deformity', 'older children']","['SIF concomitant with talectomy', 'simplified Ilizarov fixator (SIF']",['Dimeglio scores'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0009081', 'cui_str': 'Talipes equinovarus'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0441254', 'cui_str': 'Fixation device'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0188551', 'cui_str': 'Talectomy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",23.0,0.0130709,"With the numbers available in this study, there was significant improvement (p ≤ .05) in the Dimeglio scores in both groups, which was significantly more evident (p ≤ .05) among the fixator group.","[{'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Atef', 'Affiliation': 'Assistant Professor, Department of Orthopedics, Faculty of Medicine, Tanta University, Tanta, Egypt. Electronic address: ashraf.mohamed@med.tanta.edu.eg.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Rosasy', 'Affiliation': 'Professor, Department of Orthopedics, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'El-Tantawy', 'Affiliation': 'Assistant Professor, Department of Orthopedics, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2020.08.033']
2729,33218873,Concurrent brain endurance training improves endurance exercise performance.,"OBJECTIVES


Mental fatigue impairs endurance exercise. Brain endurance training (BET) - engaging in cognitively fatiguing tasks during exercise - can develop resilience to mental fatigue and improve physical performance over physical training alone. The mechanism for this effect is unknown. This experiment examines if BET enhances performance over physical training and investigates potential underlying physiological mechanisms.
DESIGN


A mixed design randomised control trial.
METHODS


Pre- and post-testing: 36 participants completed dynamic rhythmic muscular endurance handgrip tasks requiring generation of as much force as possible once a second for 300s, performed under 3 counterbalanced conditions: following 600s of a 2-back memory/attention task (subsequent); while performing a 2-back task (concurrent); and on its own (solo). Cardiac activity, electromyographic forearm activity, pre-frontal cerebral haemodynamics (near infrared spectroscopy), and force were recorded. Training: Participants (randomised to a Control or BET group) completed 24 (6 weeks) submaximal hand contractions sessions. The BET group also completed concurrent cognitive tasks (2-back, Stroop). Measures of motivation, physical and mental exertion and mental fatigue were collected throughout.
RESULTS


Endurance performance, across the 3 tasks, improved more following BET (32%) than Control (12%) (p<0.05). The better performance following BET occurred with a higher pre-frontal oxygenation during the post-training physical tasks over time relative to Control (p<0.05).
CONCLUSIONS


Concurrent BET improved endurance performance over physical training alone. This was accompanied by a training-induced maintenance of pre-frontal oxygenation, suggestive of reduced mental effort during physical activity.",2020,"RESULTS


Endurance performance, across the 3 tasks, improved more following BET (32%) than Control (12%) (p<0.05).","['Pre- and post-testing', '36 participants completed']","['Brain endurance training (BET) - engaging', 'Concurrent brain endurance training', 'Control or BET', 'Training', 'dynamic rhythmic muscular endurance handgrip tasks requiring generation of as much force as possible once a second for 300s, performed under 3 counterbalanced conditions: following 600s of a 2-back memory/attention task (subsequent); while performing a 2-back task (concurrent); and on its own (solo', 'submaximal hand contractions sessions', 'physical training alone']","['Cardiac activity, electromyographic forearm activity, pre-frontal cerebral haemodynamics (near infrared spectroscopy), and force', 'endurance performance', 'motivation, physical and mental exertion and mental fatigue', 'endurance exercise performance']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0443168', 'cui_str': 'Cardiac activity'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]",36.0,0.0713969,"RESULTS


Endurance performance, across the 3 tasks, improved more following BET (32%) than Control (12%) (p<0.05).","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Dallaway', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK. Electronic address: n.dallaway@bham.ac.uk.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ring', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.10.008']
2730,33218878,"The Effect of Preoperative Oral Versus Parenteral Dextrose Supplementation on Pain, Nausea, and Quality of Recovery After Laparoscopic Cholecystectomy.","PURPOSE


Earlier studies suggest that carbohydrate loading is effective in reducing preoperative nausea. This study was conducted to investigate the effect of preoperative oral versus parenteral carbohydrate loading on the postoperative pain, nausea, and quality of recovery (QoR).
DESIGN


Three-arm randomized, single-blind clinical trial.
METHODS


In this study, 95 adult patients scheduled for elective laparoscopic cholecystectomy were randomly assigned into three groups of preoperative intravenous dextrose 10% infusion, oral carbohydrate (OCH)-rich drink, and control. The pain and nausea severity scores were measured during recovery, 6 hours, and 24 hours thereafter. The 40-item QoR score was evaluated the day after surgery.
FINDINGS


In recovery, nausea severity was comparable among three groups, whereas pain score in the OCH group was significantly less than the controls (P = .009). Pain score in patients who received intravenous dextrose was mediocre and not statistically different from two other groups. Six and 24 hours after surgery, nausea and pain scores in OCH and dextrose infusion groups were significantly lower than the control group (P < .05). The 40-item QoR score was significantly higher in intervention groups than control participants (P < .05). Blood glucose levels were comparable in three groups before and after surgery.
CONCLUSIONS


Preoperative carbohydrate loading significantly improves the QoR after laparoscopic cholecystectomy without significant effect on blood glucose levels. Oral route more effectively controls nausea and pain than parenteral dextrose administration.",2020,The 40-item QoR score was significantly higher in intervention groups than control participants (P < .05).,"['95 adult patients scheduled for elective laparoscopic cholecystectomy', 'After Laparoscopic Cholecystectomy']","['carbohydrate loading', 'preoperative intravenous dextrose 10% infusion, oral carbohydrate (OCH)-rich drink, and control', 'preoperative oral versus parenteral carbohydrate loading', 'Preoperative Oral Versus Parenteral Dextrose Supplementation', 'intravenous dextrose']","['pain and nausea severity scores', 'postoperative pain, nausea, and quality of recovery (QoR', 'Blood glucose levels', 'QoR', 'pain score', 'blood glucose levels', 'preoperative nausea', 'Pain, Nausea, and Quality of Recovery', 'Pain score', 'nausea severity', '40-item QoR score', 'nausea and pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",95.0,0.0459098,The 40-item QoR score was significantly higher in intervention groups than control participants (P < .05).,"[{'ForeName': 'Seyed Hamzeh', 'Initials': 'SH', 'LastName': 'Mousavie', 'Affiliation': 'Department of Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Negahi', 'Affiliation': 'Department of Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Hosseinpour', 'Affiliation': 'Department of Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Mohseni', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Masood.mohseni@gmail.com.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Movassaghi', 'Affiliation': 'Department of Anesthesiology, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.07.002']
2731,33218893,"Patterns and effects of social integration on housing stability, mental health and substance use outcomes among participants in a randomized controlled Housing First trial.","INTRODUCTION


Recent research has shown that social integration, involving community integration and social support, can be protective resources for the health of homeless individuals. However, it is not clear how social integration affects health in the transition from homelessness into housing, and subsequent housing retention. This paper examines, through mixed quantitative and qualitative methods, how social integration changes over time, and how these changes relate to housing stability, substance use and mental health outcomes among a sample of homeless individuals experiencing mental illness participating in the At Home/Chez Soi Housing First randomized controlled trial in Canada.
METHODS


Longitudinal quantitative data (baseline, 6, 12, 24 month) and qualitative data ( 18 month) from the five trial sites (Moncton, Montreal, Toronto, Winnipeg and Vancouver) were examined using mixed models, mediation analyses, and thematic analysis.
RESULTS


Social integration (i.e., social network size, social interest, psychological integration) increased over time among study participants, with social network size increasing significantly more among Housing First participants than Treatment as Usual participants. Social network size mediated the effect of the intervention on the percentage of days in stable housing, indicating that the Housing First intervention may have increased participants' social network size, which in turn increased the percentage of days stably housed. No significant mediation of social integration on the effects of the intervention on mental health and substance use outcomes was found. Findings from the qualitative interviews support and expand upon these quantitative findings.",2020,"Social integration (i.e., social network size, social interest, psychological integration) increased over time among study participants, with social network size increasing significantly more among Housing First participants than Treatment as Usual participants.","['participants in a randomized controlled Housing First trial', 'Longitudinal quantitative data (baseline, 6, 12, 24 month) and qualitative data ( 18 month) from the five trial sites (Moncton, Montreal, Toronto, Winnipeg and Vancouver', 'homeless individuals experiencing mental illness participating in the At Home/Chez Soi Housing First randomized controlled trial in Canada']",['social integration'],"['social network size', 'housing stability, mental health and substance use outcomes', 'Social integration (i.e., social network size, social interest, psychological integration', 'mental health and substance use outcomes']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0676803', 'cui_str': 'Styrene-oxide isomerase'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0597478', 'cui_str': 'Social Integration'}]","[{'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0597478', 'cui_str': 'Social Integration'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.0697075,"Social integration (i.e., social network size, social interest, psychological integration) increased over time among study participants, with social network size increasing significantly more among Housing First participants than Treatment as Usual participants.","[{'ForeName': 'Maritt', 'Initials': 'M', 'LastName': 'Kirst', 'Affiliation': ""Department of Psychology, Wilfrid Laurier University, Waterloo, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada; MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Canada. Electronic address: mkirst@wlu.ca.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Friesdorf', 'Affiliation': 'Department of Psychology, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Ta', 'Affiliation': 'Department of Psychology, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Amiri', 'Affiliation': 'Department of Psychology, Wilfrid Laurier University, Waterloo, Canada.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Canada; Faculty of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': ""Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada; MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Canada; Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.""}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113481']
2732,33219007,"BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD.","BACKGROUND


Despite therapeutic advances, the management of chronic obstructive pulmonary disease (COPD) remains complex. There is growing interest in multidimensional, mind-body exercises to improve both physical and psychosocial aspects of COPD burden. Few US data are available in this population on tai chi (TC) a mind-body exercise incorporating physical activity, breathing and mindful awareness. We explored feasibility and preliminary efficacy of TC in COPD in an US academic medical setting.
METHODS


Patients with COPD Global Obstructive Lung Disease (GOLD) stages 2-4 were randomised to a 12-week TC programme or education control. At 12 weeks, those in TC were randomised again to continue in maintenance classes or not to further explore optimal duration. All groups were followed to 24 weeks. Feasibility/safety parameters were analysed descriptively. Preliminary between-group differences were estimated in symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6 min walk test, lower body strength, flexibility, physical activity).
RESULTS


Ninety-two subjects were randomised (N=61 TC, N=31 education). Mean age was 68±8 years, 66% male, mean forced expiratory volume in 1 s % predicted 57±13, 28% were GOLD stage 3-4. Overall retention was 85%. Nineteen adverse events occurred, most being study-unrelated COPD exacerbations. From baseline to 12 weeks, there were between-group improvements favouring TC, in CRQ-total (Cohen's d effect size (ES)=0.46; adj mean diff (AMD)=0.31), CRQ-emotion (ES=0.54; AMD=0.49), Centre for Epidemiologic Studies Depression (ES=-0.37; AMD=2.39) and Patient-Reported Outcome Measurement Information System (PROMIS)-fatigue (ES=-0.34; AMD=-0.17). From baseline to 24 weeks, there was an improvement favouring TC in CRQ-dyspnoea (ES=0.41; AMD=0.46). Among TC participants, there was a positive effect of maintenance classes on self-efficacy (ES=-0.69; AMD=-0.40), 6 min walk (ES=0.56; AMD=49.26 feet), PROMIS-fatigue (ES=-0.41; AMD=-0.28) and chair stand (0.43; AMD=0.56).
CONCLUSION


TC in patients with COPD is feasible and safe. Preliminary analyses support a potential modest role in improving quality-of-life, cognitive-emotional health and function that should be further studied.
TRIAL REGISTRATION NUMBER


NCT01551953.
IRB REFERENCE


BIDMC 2010P-000412; VA 2540.",2020,"Preliminary between-group differences were estimated in symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6 min walk test, lower body strength, flexibility, physical activity).
","['Mean age was 68±8 years, 66% male, mean forced expiratory volume in 1 s % predicted 57±13, 28% were GOLD stage 3-4', 'Patients with COPD Global Obstructive Lung Disease (GOLD) stages 2-4', 'Ninety-two subjects were randomised (N=61\u2009TC, N=31 education', 'patients with COPD', 'chronic obstructive pulmonary disease (COPD']","['tai chi exercise', 'TC', 'TC programme or education control']","['Overall retention', 'improvement favouring TC in CRQ-dyspnoea', 'CRQ-emotion', 'symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6\u2009min walk test, lower body strength, flexibility, physical activity', 'quality-of-life, cognitive-emotional health and function', 'Feasibility/safety parameters', 'self-efficacy', ""TC, in CRQ-total (Cohen's d effect size""]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600260', 'cui_str': 'Obstructive airways disorder'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",92.0,0.0637175,"Preliminary between-group differences were estimated in symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6 min walk test, lower body strength, flexibility, physical activity).
","[{'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA gyeh@hms.harvard.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Litrownik', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Beach', 'Affiliation': 'Division of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Klings', 'Affiliation': 'Pulmonary and Critical Care Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Reyes Nieva', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Adlin', 'Initials': 'A', 'LastName': 'Pinheiro', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000697']
2733,33219016,Expression of T-cell Exhaustion Molecules and Human Endogenous Retroviruses as Predictive Biomarkers for response to Nivolumab in Metastatic Clear Cell Renal Cell Carcinoma.,"PURPOSE


We sought to validate levels of CD8 +  tumor-infiltrating cells (TIC) expressing PD-1 but not TIM-3 and LAG-3 (IF biomarker) (Pignon et al, 2019) and to investigate human endogenous retroviruses (hERVs) as predictors of response to anti-PD-1 in a randomized trial of nivolumab (nivo) versus everolimus (evero) in patients with metastatic clear cell renal cell carcinoma (mccRCC) (CheckMate-025).
EXPERIMENTAL DESIGN


Tumor tissues (nivo: n=116, evero: n=107) were analyzed by multiparametric immunofluorescence (IF) and qRT-PCR. Genomic/transcriptomic analyses were performed in a subset of samples. Clinical endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and durable response rate (DRR, defined as CR or PR with a PFS ≥ 12 months).
RESULTS


In the nivo (but not evero) arm, patients with high-IF biomarker density (24/116, 20.7%) had higher ORR (45.8% vs 19.6%, p=0.01) and DRR (33.3% vs 14.1%, p=0.03) and longer median PFS (9.6 vs 3.7 months, p=0.03) than low-IF biomarker patients. By RNA-seq, several inflammatory pathways (q<0.1) and immune-related gene signature scores (q<0.05) were enriched in the high-IF biomarker group. When combined with the IF biomarker, tumor cell (TC) PD-L1 expression (≥1%) further separated clinical outcomes in the nivo arm. ERVE4 expression was associated with increased DRR and longer PFS in nivo-treated patients.
CONCLUSION


High levels of CD8 +  TIC expressing PD-1 but not TIM-3 and LAG-3 and ERVE4 expression predicted response to nivo (but not to evero) in mccRCC patients. Combination of the IF biomarker with TC PD-L1 improved its predictive value, confirming our previous findings.",2020,"By RNA-seq, several inflammatory pathways (q<0.1) and immune-related gene signature scores (q<0.05) were enriched in the high-IF biomarker group.","['Tumor tissues (nivo: n=116, evero', 'Metastatic Clear Cell Renal Cell Carcinoma', 'patients with metastatic clear cell renal cell carcinoma (mccRCC) (CheckMate-025']","['TC PD-L1', 'CD8 +  tumor-infiltrating cells (TIC) expressing PD-1 but not TIM-3 and LAG-3', 'nivolumab (nivo) versus everolimus (evero']","['DRR', 'objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and durable response rate (DRR, defined as CR or PR with a PFS ≥ 12 months', 'tumor cell (TC) PD-L1 expression', 'ERVE4 expression', 'DRR and longer PFS', 'higher ORR', 'longer median PFS']","[{'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C3537335', 'cui_str': 'TIMD3 Protein'}, {'cui': 'C1456336', 'cui_str': 'lymphocyte-activation gene 3 protein, human'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0640207,"By RNA-seq, several inflammatory pathways (q<0.1) and immune-related gene signature scores (q<0.05) were enriched in the high-IF biomarker group.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ficial', 'Affiliation': 'Pathology, Harvard Medical School.'}, {'ForeName': 'Opeyemi A', 'Initials': 'OA', 'LastName': 'Jegede', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': ""Sant'Angelo"", 'Affiliation': ""Pathology, Brigham and Women's Hospital.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Translational Immunogenomics Lab, Dana-Farber Cancer Institute.'}, {'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Flaifel', 'Affiliation': ""Pathology, Brigham and Women's Hospital.""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Pignon', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Braun', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Translational Medicine, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Sticco-Ivins', 'Affiliation': ""Pathology, Brigham and Women's Hospital.""}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Catalano', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute.'}, {'ForeName': 'Gordon J', 'Initials': 'GJ', 'LastName': 'Freeman', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Arlene H', 'Initials': 'AH', 'LastName': 'Sharpe', 'Affiliation': 'Immunology, Harvard Medical School.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Heme/Onc, Beth Israel Deaconess Medical Center, Harvard Medical School.'}, {'ForeName': 'Sachet A', 'Initials': 'SA', 'LastName': 'Shukla', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital ssignoretti@partners.org.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3084']
2734,33220526,Impact of 9-minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial.,"BACKGROUND AND AIMS


Although current quality indicators of colonoscopy recommend 6 minutes as the minimum standard for withdrawal time (WT), the impact of a WT longer than 6 minutes on neoplasia detection is unclear.
METHODS


A multicenter randomized controlled trial involving 1027 patients was conducted from January 2018 to July 2019. Participants were randomly divided into a 9-minute (n=514) and 6-minute (n=513) WT group, and a timer was used to adjust the withdrawal speed. The primary outcome was the adenoma detection rate (ADR).
RESULTS


Intention-to-treat analysis showed a significantly higher ADR in the 9-minute versus 6-minute WT group (36.6% vs. 27.1%, P=0.001). Prolonging WT from 6 to 9 minutes significantly increased ADR of the proximal colon (21.4% vs. 11.9%, P<0.001) as well as of the less experienced colonoscopists (36.8% vs. 23.5%, P=0.001). Improvements were also observed in the polyp detection rate (58.0% vs. 47.8%, P<0.001), and mean number of polyps and adenomas detected per colonoscopy (1.1 vs. 0.9, P=0.002; 0.5 vs. 0.4, P=0.008, respectively). The higher ADRs in 9-minute WT were also confirmed by the per-protocol (PP) analysis and subgroup analyses, with an increased rate of sessile serrated lesion detection in the 9-minute WT by PP analysis (4.0% vs. 1.3%, P=0.04). Multivariate logistic regression demonstrated that the 9-minute WT was independently associated with increased ADR (P=0.005).
CONCLUSION


Prolonging WT from 6 to 9 minutes significantly improved ADR, especially in the proximal colon and for less experienced colonoscopists. A 9-minute WT benchmark should be considered as one of the quality indicators of colonoscopy.",2020,"Improvements were also observed in the polyp detection rate (58.0% vs. 47.8%, P<0.001), and mean number of polyps and adenomas detected per colonoscopy (1.1 vs. 0.9, P=0.002; 0.5 vs. 0.4, P=0.008, respectively).",['1027 patients was conducted from January 2018 to July 2019'],[],"['Adenoma Detection Rate', 'polyp detection rate', 'adenoma detection rate (ADR', 'rate of sessile serrated lesion detection', 'mean number of polyps and adenomas detected per colonoscopy', 'ADR of the proximal colon', 'ADR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0205348', 'cui_str': 'Sessile'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}]",1027.0,0.164371,"Improvements were also observed in the polyp detection rate (58.0% vs. 47.8%, P<0.001), and mean number of polyps and adenomas detected per colonoscopy (1.1 vs. 0.9, P=0.002; 0.5 vs. 0.4, P=0.008, respectively).","[{'ForeName': 'Shengbing', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, 905th hospital of PLA NAVY, Shanghai, China.'}, {'ForeName': 'Shuling', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Meng', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Rundong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Lumin', 'Initials': 'L', 'LastName': 'Bo', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Pan', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology, The Second Clinical Medical College, Jinan University, Shenzhen, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, Yantaishan Hospital of Yantai City, Yantai, Shandong, China.'}, {'ForeName': 'Jianqiu', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Department of Gastroenterology, The Seventh Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, The Seventh Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, The Seventh Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Datong, Datong, Shanxi, China.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Datong, Datong, Shanxi, China.""}, {'ForeName': 'Aixia', 'Initials': 'A', 'LastName': 'Gong', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, The First Affiliated Hospital, The School Medical College, Shihezi University, Shihezi, Xinjiang, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, Ningbo Medical Center Lihuili Eastern Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Ningbo Medical Center Lihuili Eastern Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Shaofeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Changzhi People's Hospital, Changzhi, Shanxi, China.""}, {'ForeName': 'Caiwen', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': ""Department of Gastroenterology, Changzhi People's Hospital, Changzhi, Shanxi, China.""}, {'ForeName': 'Youlin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.'}, {'ForeName': 'Yangbei', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Gastroenterology, Shanghai Eighth People's Hospital, Shanghai, China.""}, {'ForeName': 'Rui-Jun', 'Initials': 'RJ', 'LastName': 'Ma', 'Affiliation': ""Center for Gastrointestinal Endoscopy, Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Center for Gastrointestinal Endoscopy, Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China.""}, {'ForeName': 'Yincai', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Gastroenterology, Qinghai Provincial People's Hospital, Xining, Qinghai, China.""}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China. Electronic address: li.zhaoshen@hotmail.com.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastroenterology, Changhai Hospital, Second Military Medical University/Naval Medical University, Shanghai, China; Digestive Endoscopy Center, Changhai Hospital, Naval/Second Military Medical University, Shanghai, China; National Clinical Research Center for Digestive Diseases, Shanghai, China; National Quality Control Center of Digestive Endoscopy, Shanghai, China.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.11.019']
2735,33220568,Comparison of health service use trajectories of residential aged care residents reviewed by a hospital avoidance program versus usual care.,"OBJECTIVE


To compare health service use trajectories of residential aged care facility (RACF) residents reviewed by the Aged Care Rapid Response Team (ARRT) to RACF residents who received usual care.
METHODS


A retrospective group-based trajectory analysis of RACF residents aged ≥65 years who were reviewed by ARRT during 1 July 2015 to 30 June 2016 was conducted. Health service use trajectories were followed for two years to 30 June 2018 and compared to RACF residents aged ≥65 years who lived in the same Local Health District and received usual care.
RESULTS


There were 2,245 ARRT-reviewed resident hospitalisations and 11,892 usual care resident hospital admissions during 2015-16. Trajectory analysis categorised ARRT-reviewed residents into four groups and usual care residents into three groups. Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents. Additionally, gender predicted group membership in ARRT-reviewed RACF residents and fall-related injuries predicted group membership in usual care RACF residents.
CONCLUSION


The identification of health service use trajectories assists in understanding hospital use by older RACF residents and may offer guidance in the design of prevention measures, including hospital avoidance programs.",2020,"Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents.","['residential aged care facility (RACF) residents reviewed by the Aged Care Rapid Response Team (ARRT) to RACF residents who received usual care', 'Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents', 'residential aged care residents', 'RACF residents aged ≥65 years who were reviewed by ARRT during 1 July 2015 to 30 June 2016 was conducted', 'residents aged ≥65 years who lived in the same Local Health District and received usual care', 'Trajectory analysis categorised ARRT-reviewed residents into four groups and usual care residents into three groups', 'There were 2,245 ARRT-reviewed resident hospitalisations and 11,892 usual care resident hospital admissions during 2015-16', 'older RACF residents']","['RACF', 'hospital avoidance program versus usual care']",[],"[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C2718033', 'cui_str': 'Hospital Medical Emergency Team'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0135492,"Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents.","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia. Electronic address: luke.testa@mq.edu.au.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Hardy', 'Affiliation': 'Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia; The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Jepson', 'Affiliation': 'Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Braithwaite', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Mitchell', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104293']
2736,33220574,A spiritual education course to enhance nursing students' spiritual competencies.,"The study aimed to determine the impact of an elective spiritual education course for nursing students on spiritual competencies. A convenience sample of nursing students (N = 92) was recruited from a baccalaureate school of nursing between February and July 2016. The intervention group (n = 45) was comprised of students enrolled in the elective spiritual education course which integrated non-Christian Eastern cultural beliefs; the control group was comprised of students not enrolled in the elective (n = 47). A quasi-experimental design examined pretest, posttest, and follow-up data from students' self-administered questionnaires. The intervention effect of the course was analyzed using generalized estimation equation. The results indicated posttest scores among nursing students in the intervention group were significantly better than the comparison group for spiritual health. Practicum stress and professional commitment were significantly better at follow-up. Spiritual care attitudes, caring behavior, and religious belief were significantly improved from pretest to posttest, and at follow-up for the intervention group compared with the control group. In conclusion, a spiritual education course should be considered as a regular course in the nursing curriculum, which could improve students' spiritual competencies, individual spiritual growth, and the ability to care for patients.",2020,The results indicated posttest scores among nursing students in the intervention group were significantly better than the comparison group for spiritual health.,"['A convenience sample of nursing students (N\xa0=\xa092) was recruited from a baccalaureate school of nursing between February and July 2016', 'nursing students on spiritual competencies']","['elective spiritual education course which integrated non-Christian Eastern cultural beliefs; the control group', 'elective spiritual education']","['Spiritual care attitudes, caring behavior, and religious belief', 'Practicum stress and professional commitment', 'spiritual health']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035045', 'cui_str': 'Religious Beliefs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0686997', 'cui_str': 'Spiritual health of patient'}]",,0.0118876,The results indicated posttest scores among nursing students in the intervention group were significantly better than the comparison group for spiritual health.,"[{'ForeName': 'Yi-Chien', 'Initials': 'YC', 'LastName': 'Chiang', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Chang Gung Memorial Hospital at Linkou, Taiwan, ROC; Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC. Electronic address: ycchiang@gw.cgust.edu.tw.'}, {'ForeName': 'Hsiang-Chun', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC. Electronic address: cathylee@gw.cgust.edu.tw.'}, {'ForeName': 'Tsung-Lan', 'Initials': 'TL', 'LastName': 'Chu', 'Affiliation': 'Administration Center of Quality Management Department, Chang Gung Medical Foundation, Taiwan, ROC. Electronic address: jec75@cgmh.org.tw.'}, {'ForeName': 'Chin-Yen', 'Initials': 'CY', 'LastName': 'Han', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC. Electronic address: cyhan@gw.cgust.edu.tw.'}, {'ForeName': 'Ya-Chu', 'Initials': 'YC', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC; Department of Nursing, Chang Gung Memorial Hospital at Linkou. Electronic address: yjshiao@gw.cgust.edu.tw.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102907']
2737,32690404,"Re: Michael S. Hofman, Nathan Lawrentschuk, Roslyn J. Francis, et al. Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomized, Multicenter Study. Lancet 2020;395:1208-16.",,2020,,['Patients with High-risk Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0238972,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Evangelista', 'Affiliation': 'Nuclear Medicine Unit, Department of Medicine, University of Padua, Padua, Italy. Electronic address: laura.evangelista@unipd.it.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'De Salvo', 'Affiliation': 'Clinical Trials and Biostatistics Unit, IRCCS Istituto Oncologico Veneto, Padova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Zattoni', 'Affiliation': 'Urology Unit, Academic Medical Centre Hospital, Udine, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Novara', 'Affiliation': 'Department of Surgery, Oncology, and Gastroenterology, Urology Clinic, University of Padua, Padua, Italy.'}]",European urology oncology,['10.1016/j.euo.2020.06.013']
2738,33218568,Effects of eight-week water versus mat pilates on female patients with chronic nonspecific low back pain: Double-blind randomized clinical trial.,"OBJECTIVE


To evaluate the effects of water and mat Pilates on pain, disability, and static and dynamic balance in patients with chronic nonspecific low back pain (CNLBP).
METHODS


Twenty-four participants with CNLBP were randomly allocated into two groups (n = 12) that perform water and mat Pilates exercises for 24 sessions (8-week, 3 sessions per week). The value for pain, disability and balance were measured before and after the exercise program using the Visual Analogue Scale, Oswestry Disability Questionnaire and Biodex Balance System respectively.
RESULTS


A paired t-test revealed significant differences in pain severity and disability in both groups after they performed the Pilates program (P ≤ 0.05). Mat Pilates improved static balance as the participants performed the tests with their eyes open and closed (P = 0.02, P = 0.04). Its effect on dynamic balance, however, was not statistically significant (ES = 0/33, P = 0/34). The same Pilates program performed in water did not show significant effects on balance despite a decline in body sway (P˃0/05). There was no difference between the two groups (P˃0/05).
CONCLUSION


The results suggest that both mat and water Pilates exercise program have beneficial effects on the treatment of LBP. Nevertheless, the low impact of the mat and water Pilates program on balance improvement suggests more investigation on Pilates training or complementary exercises to improve balance in patients with CNLBP.",2020,"RESULTS


A paired t-test revealed significant differences in pain severity and disability in both groups after they performed the Pilates program (P ≤ 0.05).","['patients with chronic nonspecific low back pain (CNLBP', 'patients with CNLBP', 'female patients with chronic nonspecific low back pain', 'Twenty-four participants with CNLBP']","['perform water and mat Pilates exercises', 'eight-week water versus mat pilates', 'water and mat Pilates']","['pain, disability and balance', 'dynamic balance', 'pain, disability, and static and dynamic balance', 'Visual Analogue Scale, Oswestry Disability Questionnaire and Biodex Balance System respectively', 'pain severity and disability', 'static balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C1321049', 'cui_str': 'Pilates exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",24.0,0.0227842,"RESULTS


A paired t-test revealed significant differences in pain severity and disability in both groups after they performed the Pilates program (P ≤ 0.05).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yalfani', 'Affiliation': 'Department of Sports Rehabilitation, Faculty of Sport Science, Bu-Ali Sina University, Hamedan, Iran. Electronic address: Ali_yalfani@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Raeisi', 'Affiliation': 'Department of Sports Rehabilitation, Faculty of Sport Science, Arak University, Arak, Iran. Electronic address: Z_raisi13@yahoo.com.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Koumasian', 'Affiliation': 'M.A of Sports Rehabilitation, Bu-Ali Sina University, Hamedan, Iran. Electronic address: Z_koumasian@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.06.002']
2739,33218692,"A 24-week intervention based on nutrition care process improves diet quality, body mass index, and motivation in children and adolescents with obesity.","Higher motivation could support to lead behavioral change for obese children and adolescents. This study aimed to evaluate the effects of a nutrition care process (NCP)-based intervention targeted on diet and weight status in moderate to severe obese children and adolescents in Korea. One hundred four subjects (mean age: 10.95 years, body mass index (BMI) ≥97th percentile of age-sex) participated in the present study. Subjects were divided into a usual care group (UG) and a nutrition group (NG). All participants underwent nutrition education 6 times. The NG received individual access and continuous monitoring and setting goals with respect to nutritional problems. Consumption of high-calorie, low-nutrient (HCLN) food was significantly decreased (P < .05) and the Diet Quality Index-International (DQI-I) score also increased with respect to sodium (P < .001). The total self-efficacy score was increased from 9.15 to 10.14 points (P < .01). After 24 weeks, the BMI-z-score decreased from 2.27 to 2.19 in the NG (P < .05); however, no group difference was found. BMI-z-score was negatively associated with self-efficacy (β = -0.03, P < .019). NCP-based intervention might be helpful to solve dietary problems by enhancing self-efficacy and lower BMI-z-score in moderately to severely obese children and adolescents.",2020,The total self-efficacy score was increased from 9.15 to 10.14 points (P < .01).,"['children and adolescents with obesity', 'One hundred four subjects (mean age: 10.95 years, body mass index (BMI) ≥97th percentile of age-sex) participated in the present study', 'moderate to severe obese children and adolescents in Korea', 'obese children and adolescents']","['nutrition care process (NCP)-based intervention', 'usual care group (UG) and a nutrition group (NG', 'NCP-based intervention']","['total self-efficacy score', 'Consumption of high-calorie, low-nutrient (HCLN) food', 'Diet Quality Index-International (DQI-I) score', 'diet quality, body mass index, and motivation', 'BMI-z-score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C1258068', 'cui_str': 'Nutrition management'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",104.0,0.021527,The total self-efficacy score was increased from 9.15 to 10.14 points (P < .01).,"[{'ForeName': 'So Yeong', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yongin, Gyeonggi-do, 17104, South Korea. Electronic address: zxc931102@khu.ac.kr.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Research Institute of Medical Nutrition, Kyung Hee University, Seoul 02447, South Korea. Electronic address: jieunkim@khu.ac.kr.'}, {'ForeName': 'Seulki', 'Initials': 'S', 'LastName': 'Oh', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yongin, Gyeonggi-do, 17104, South Korea. Electronic address: 90selki@khu.ac.kr.'}, {'ForeName': 'YoonMyung', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'University College, Yonsei University International Campus, Incheon 21983, South Korea. Electronic address: yoonkim@yonsei.ac.kr.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woo', 'Affiliation': 'Department of Family Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Gyeonggi-do, 14068, South Korea. Electronic address: hjejcross@naver.com.'}, {'ForeName': 'Han Byul', 'Initials': 'HB', 'LastName': 'Jang', 'Affiliation': 'Center for Biomedical Sciences, Korea National Institute of Health, Cheongju, Chungbuk 28159, South Korea. Electronic address: greatstar@korea.kr.'}, {'ForeName': 'Hye-Ja', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Center for Biomedical Sciences, Korea National Institute of Health, Cheongju, Chungbuk 28159, South Korea. Electronic address: hyejalee@korea.kr.'}, {'ForeName': 'Sang Ick', 'Initials': 'SI', 'LastName': 'Park', 'Affiliation': 'Center for Biomedical Sciences, Korea National Institute of Health, Cheongju, Chungbuk 28159, South Korea. Electronic address: parksi@nih.go.kr.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Gyeonggi-do, 14068, South Korea. Electronic address: beloved920@gmail.com.'}, {'ForeName': 'Hyunjung', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Medical Nutrition, Kyung Hee University, Yongin, Gyeonggi-do, 17104, South Korea; Research Institute of Medical Nutrition, Kyung Hee University, Seoul 02447, South Korea. Electronic address: hjlim@khu.ac.kr.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.09.005']
2740,33218742,"Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study.","PURPOSE


Binge-eating disorder (BED), the most prevalent eating disorder, is associated strongly with obesity and functional impairments. Few evidence-based treatments for BED exist; a pharmacotherapy effective in reducing both binge eating and weight needs to be identified. This placebo-controlled double-blind pilot RCT evaluated the acute effects of naltrexone + bupropion (NB) on BED with obesity and examined the longer-term effects through 6-month follow-up after the discontinuation of medication.
METHODS


Twenty-two adult patients with BED were randomized to receive 12 weeks of double-blind treatment with fixed-dose NB (naltrexone + bupropion XL 50/300 mg) or placebo. Independent (blinded) researcher-clinicians evaluated patients at major outcome time points (baseline, posttreatment, and 6-month follow-up after the treatment period); patients were also evaluated for the tracking of course/tolerability throughout treatments and at 3-month follow-up. Primary outcomes were changes from baseline in binge-eating frequency and percentage weight. Secondary outcomes were changes in eating-disorder psychopathology and depression.
FINDINGS


A total of 22 patients were enrolled (86.4% women; mean age, 50.4 years), with 77.3% of patients completing treatments; completion rates (NB, 83.3%; placebo, 70.0%) and adverse events did not differ significantly between NB and placebo. Analyses revealed significant reductions from baseline in binge-eating, eating-disorder psychopathology, depression, and weight during treatment, but these changes with NB did not differ significantly from those with placebo. The percentage of patients who attained 3% weight loss was significantly greater with NB than with placebo (45.5% vs 0%); weight-loss and binge-eating reductions were significantly correlated in the group that received NB. At 6-month follow-up, outcomes remained improved relative to baseline, with no significant differences between NB and placebo.
IMPLICATIONS


The findings from this pilot RCT suggest that NB was well-tolerated in these patients with BED and comorbid obesity. Most outcomes were not statistically different between NB and placebo. A larger-scale, adequately powered RCT is needed for determining the efficacy of NB in the treatment of BED. ClinicalTrials.gov identifier: NCT02317744.",2020,"At 6-month follow-up, outcomes remained improved relative to baseline, with no significant differences between NB and placebo.
","['Twenty-two adult patients with BED', '22 patients were enrolled (86.4% women; mean age, 50.4 years), with 77.3% of patients completing treatments; completion rates (NB, 83.3', 'patients with BED and comorbid obesity', 'Binge-eating Disorder with Obesity']","['Naltrexone\xa0+ Bupropion Combination', 'fixed-dose NB (naltrexone\xa0+\xa0bupropion XL 50/300\xa0mg) or placebo', 'naltrexone\xa0+\xa0bupropion (NB', 'placebo']","['weight loss', 'binge-eating frequency and percentage weight', 'binge-eating, eating-disorder psychopathology, depression, and weight', 'weight-loss and binge-eating reductions', 'adverse events', 'changes in eating-disorder psychopathology and depression']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",22.0,0.528421,"At 6-month follow-up, outcomes remained improved relative to baseline, with no significant differences between NB and placebo.
","[{'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA; Department of Psychology, Yale University, New Haven, CT, USA. Electronic address: carlos.grilo@yale.edu.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Lydecker', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA; Department of Psychiatry, Lawrence and Memorial Hospital, New London, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, New Haven, CT, USA; Department of Biostatistics, School of Public Health, Yale University, New Haven, CT, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.10.010']
2741,33219136,Regional differences in the response to acute blood pressure lowering after cerebral hemorrhage.,"OBJECTIVE


To compare the impact of intensive blood pressure (BP) lowering right after intracerebral hemorrhage (ICH) on clinical and hematoma outcomes among patients from different geographic locations, we performed a prespecified sub-analysis of the randomized, multi-national, two-group, open-label trial to determine the efficacy of rapidly lowering BP in hyperacute ICH (ATACH-2), involving 537 patients from East Asia and 463 recruited outside of Asia.
METHODS


Eligible patients were randomly assigned to a systolic BP (SBP) target of 110-139 mmHg (intensive treatment) or 140-179 mmHg (standard treatment). Pre-defined outcomes were: poor functional outcome (modified Rankin Scale score of 4-6 at 90 days), death within 90 days, hematoma expansion at 24 hours; and cardio-renal adverse events within 7 days.
RESULTS


Poor functional outcomes (32.0% versus 45.9%), death (1.9% versus 13.3%), and cardio-renal adverse events (3.9% versus 11.2%) occurred significantly less in patients from Asia than those outside of Asia. The treatment-by-cohort interaction was not significant for any outcomes. Only patients from Asia showed a lower incidence of hematoma expansion with intensive treatment (adjusted RR 0.56, 95% CI 0.38-0.83). Both Asian (3.53, 1.28-9.64) and non-Asian cohorts (1.71, 1.00-2.93) showed a higher incidence of cardio-renal adverse events with intensive treatment.
CONCLUSIONS


Poor functional outcomes and death 90 days after ICH were less common in patients from East Asia than those outside of Asia. Hematoma expansion, a potential predictor for poor clinical outcome, was attenuated by intensive BP lowering only in the Asian cohort.
CLINICALTRIALSGOV IDENTIFIER


NCT01176565.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that, for patients from East Asia with intracerebral hemorrhage, intensive blood pressure lowering significantly reduces the risk of hematoma expansion.",2020,"CONCLUSIONS


Poor functional outcomes and death 90 days after ICH were less common in patients from East Asia than those outside of Asia.","['Eligible patients', 'patients from different geographic locations', 'patients from East Asia with intracerebral hemorrhage', '537 patients from East Asia and 463 recruited outside of Asia']","['systolic BP (SBP', 'intensive blood pressure (BP) lowering right after intracerebral hemorrhage (ICH']","['hematoma expansion', 'cardio-renal adverse events', 'death', 'poor functional outcome (modified Rankin Scale score of 4-6 at 90 days), death within 90 days, hematoma expansion at 24 hours; and cardio-renal adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",537.0,0.102557,"CONCLUSIONS


Poor functional outcomes and death 90 days after ICH were less common in patients from East Asia than those outside of Asia.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan toyoda@ncvc.go.jp.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kanta', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Neurology, St Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Shiokawa', 'Affiliation': 'Department of Neurosurgery and Stroke Center, Kyorin University School of Medicine, Mitaka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Iwama', 'Affiliation': 'Department of Neurosurgery, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Hoshino', 'Affiliation': 'Department of Neurology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, Germany.'}, {'ForeName': 'Byung-Woo', 'Initials': 'BW', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011229']
2742,33219142,Efficacy and safety of rozanolixizumab in moderate-to-severe generalised myasthenia gravis: A phase 2 RCT.,"OBJECTIVE


To explore the clinical efficacy and safety of subcutaneous (SC) rozanolixizumab, an anti-neonatal Fc receptor humanized monoclonal antibody, in patients with generalized myasthenia gravis (gMG).
METHODS


In this phase 2a, randomized, double-blind, placebo-controlled, 2-period, multicenter trial (NCT03052751), patients were randomized (1:1) in period 1 (days 1-29) to 3 once-weekly (Q1W) SC infusions of rozanolixizumab 7 mg/kg or placebo. In period 2 (days 29-43), patients were re-randomized to either rozanolixizumab 7 mg/kg or 4 mg/kg (3 Q1W SC infusions), followed by an observation period (days 44-99). Primary endpoint: change from baseline to day 29 in Quantitative Myasthenia Gravis (QMG) score. Secondary endpoints: change from baseline to day 29 in MG-Activities of Daily Living (MG-ADL) and MG-Composite (MGC) scores; safety.
RESULTS


Forty-three patients were randomized (rozanolixizumab: 21 patients; placebo: 22 [period 1]). Least squares (LS) mean change from baseline to day 29 for rozanolixizumab vs placebo: QMG (LS mean: -1.8 vs -1.2; difference: -0.7; 95% UCL: 0.8;  p  = 0.221; not statistically significant), MG-ADL (LS mean: -1.8 vs -0.4; difference: -1.4; 95% UCL: -0.4), and MGC (LS mean: -3.1 vs -1.2; difference: -1.8; 95% UCL: 0.4) scores. Efficacy measures continued to improve with rozanolixizumab 7 mg/kg in period 2. The most common adverse event in period 1 was headache (rozanolixizumab: 57%; placebo: 14%).
CONCLUSION


While change from baseline in QMG was not statistically significant, the data overall suggest rozanolixizumab may provide clinical benefit in patients with gMG and was generally well tolerated. Phase 3 evaluation is ongoing (NCT03971422).
CLASSIFICATION OF EVIDENCE


This study provides class I evidence that for patients with gMG, rozanolixizumab is well tolerated, but did not significantly improve QMG score.",2020,"While change from baseline in QMG was not statistically significant, the data overall suggest rozanolixizumab may provide clinical benefit in patients with gMG and was generally well tolerated.","['moderate-to-severe generalised myasthenia gravis', 'patients with generalized myasthenia gravis (gMG', 'Forty-three patients were randomized (rozanolixizumab: 21 patients']","['placebo', 'subcutaneous (SC) rozanolixizumab', 'rozanolixizumab 7 mg/kg or placebo', 'rozanolixizumab', 'rozanolixizumab vs placebo: QMG']","['Efficacy and safety', 'baseline to day 29 in MG-Activities of Daily Living (MG-ADL) and MG-Composite (MGC) scores; safety', 'tolerated', 'Quantitative Myasthenia Gravis (QMG) score', 'QMG score']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C4726717', 'cui_str': 'rozanolixizumab'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4726717', 'cui_str': 'rozanolixizumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]",43.0,0.751198,"While change from baseline in QMG was not statistically significant, the data overall suggest rozanolixizumab may provide clinical benefit in patients with gMG and was generally well tolerated.","[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada Vera.bril@utoronto.ca.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'Department of Neurology, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Greve', 'Affiliation': 'UCB Pharma, Monheim-am-Rhein, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kiessling', 'Affiliation': 'UCB Pharma, Monheim-am-Rhein, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Woltering', 'Affiliation': 'UCB Pharma, Monheim-am-Rhein, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Griffin', 'Affiliation': 'iMed Communications, Macclesfield, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van den Bergh', 'Affiliation': 'Neuromuscular Reference Centre, Department of Neurology, University Hospital Saint-Luc, University of Louvain, Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011108']
2743,33219150,Predictive score for complete occlusion of intracranial aneurysms treated by flow-diverter stents using machine learning.,"BACKGROUND


Complete occlusion of an intracranial aneurysm (IA) after the deployment of a flow-diverter stent is currently unpredictable. The aim of this study was to develop a predictive occlusion score based on pretreatment clinical and angiographic criteria.
METHODS


Consecutive patients with ≥6 months follow-up were included from 2008 to 2019 and retrospectively analyzed. Each IA was evaluated using the Raymond-Roy occlusion classification (RROC) and dichotomized as occluded (A) or residual (B/C); 80% of patients were randomly assigned to the training sample. Feature selection and binary outcome prediction relied on logistic regression and threshold maximizing class separation selected by a CART tree algorithm. The feature selection was addressed by a genetic algorithm selected from the 30 pretreatment available variables.
RESULTS


The study included 146 patients with 154 IAs. Feature selection yielded a combination of six variables with a good cross-validated accuracy on the test sample, a combination we labeled DIANES score (IA diameter, indication, parent artery diameter ratio, neck ratio, side-branch artery, and sex). A score of more than -6 maximized the ability to predict RROC=A with sensitivity of 87% (95% CI 79% to 95%) and specificity of 82% (95% CI 64% to 96%) in the training sample. Accuracy was 86% (95% CI 79% to 94%). In the test sample, sensitivity and specificity were 89% (95% CI 77% to 98%) and 60% (95% CI 33% to 86%), respectively. Accuracy was 81% (95% CI 69% to 91%).
CONCLUSION


A score was developed as a grading scale for prediction of the final occlusion status of IAs treated with a flow-diverter stent.",2020,"Accuracy was 81% (95% CI 69% to 91%).
","['Consecutive patients with ≥6 months follow-up were included from 2008 to 2019 and retrospectively analyzed', '146 patients with 154 IAs']",[],"['sensitivity and specificity', 'predictive occlusion score', 'Accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191279', 'cui_str': '154'}]",[],"[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",146.0,0.0696265,"Accuracy was 81% (95% CI 69% to 91%).
","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Guédon', 'Affiliation': 'Biosurgical Research Lab (Carpentier Foundation), European Georges-Pompidou Hospital, INSERM UMR_S 1140, University of Paris, Paris, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Thépenier', 'Affiliation': 'French Armed Forces Biomedical Research Institute (IRBA), Brétigny-sur-Orge, France.'}, {'ForeName': 'Eimad', 'Initials': 'E', 'LastName': 'Shotar', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gabrieli', 'Affiliation': 'Department of Neuroradiology, University of Padova Faculty of Medicine and Surgery, Padova, Veneto, Italy.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Mathon', 'Affiliation': 'Department of Neurosurgery, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Premat', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lenck', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Degos', 'Affiliation': 'Sorbonne University, Paris, Île-de-France, France.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Sourour', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Clarençon', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, AP-HP, Paris, France frederic.clarencon@aphp.fr.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2020-016748']
2744,33219169,The effectiveness of theory-based intervention to improve haemoglobin levels among women with anaemia in pregnancy.,"BACKGROUND


Anaemia in pregnancy is considered a public health problem throughout the world. The effects of the existing intervention in ensuring compliance to the subscribed regimen and the impact of nutrition education in enhancing dietary modification during pregnancy in Malaysia have been minimal. This study aims to develop, implement and evaluate the effects of the Health Belief Model educational intervention on haemoglobin level among anaemic pregnant women.
METHODS


This is a quasi-experimental research with prepost test design with control group involving 81 participants per group from two health clinics in Sepang. The primary outcome was a change in the haemoglobin levels following educational intervention. Secondary outcomes include knowledge on anaemia, Health Belief Model (HBM) constructs, dietary iron intake and compliance towards iron supplementation. The intervention group received a HBMbased education intervention programme.
RESULTS


The response rate in the intervention and control group were 83.9% and 82.7% respectively. Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
CONCLUSION


HBM-based health education programme has proven to be effective in improving the haemoglobin levels, knowledge scores, perceived severity scores and compliance level of participants. The study results emphasized on the effectiveness of such an approach, therefore it is recommended that future educational interventions which aim at increasing preventive healthy behaviours in pregnant women may benefit from the application of this model in primary health care settings.",2020,"Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
","['81 participants per group from two health clinics in Sepang', 'anaemic pregnant women', 'pregnant women', 'women with anaemia in pregnancy']","['Health Belief Model educational intervention', 'HBMbased education intervention programme', 'existing intervention', 'theory-based intervention']","['response rate', 'knowledge on anaemia, Health Belief Model (HBM) constructs, dietary iron intake and compliance towards iron supplementation', 'mean haemoglobin level', 'haemoglobin levels', 'knowledge score', 'perceived severity score', 'proportion of high compliance level', 'haemoglobin level']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271930', 'cui_str': 'Anemia of pregnancy'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0376520', 'cui_str': 'Dietary Iron'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205250', 'cui_str': 'High'}]",81.0,0.0911541,"Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hasneezah', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Rosliza', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, 43400 Serdang, Selangor, Malaysia. rosliza_abmanaf@upm.edu.my.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Salmiah', 'Affiliation': 'IUniversiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Appanah', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Nutrition and Dietetics, 43400 Serdang, Selangor, Malaysia.'}]",The Medical journal of Malaysia,[]
2745,33219313,MDMA-induced changes in within-network connectivity contradict the specificity of these alterations for the effects of serotonergic hallucinogens.,"It has been reported that serotonergic hallucinogens like lysergic acid diethylamide (LSD) induce decreases in functional connectivity within various resting-state networks. These alterations were seen as reflecting specific neuronal effects of hallucinogens and it was speculated that these shifts in connectivity underlie the characteristic subjective drug effects. In this study, we test the hypothesis that these alterations are not specific for hallucinogens but that they can be induced by monoaminergic stimulation using the non-hallucinogenic serotonin-norepinephrine-dopamine releasing agent 3,4-methylenedioxymethamphetamine (MDMA). In a randomized, placebo-controlled, double-blind, crossover design, 45 healthy participants underwent functional magnetic resonance imaging (fMRI) following oral administration of 125 mg MDMA. The networks under question were identified using independent component analysis (ICA) and were tested with regard to within-network connectivity. Results revealed decreased connectivity within two visual networks, the default mode network (DMN), and the sensorimotor network. These findings were almost identical to the results previously reported for hallucinogenic drugs. Therefore, our results suggest that monoaminergic substances can induce widespread changes in within-network connectivity in the absence of marked subjective drug effects. This contradicts the notion that these alterations can be regarded as specific for serotonergic hallucinogens. However, changes within the DMN might explain antidepressants effects of some of these substances.",2020,"Results revealed decreased connectivity within two visual networks, the default mode network (DMN), and the sensorimotor network.",['45 healthy participants underwent'],"['placebo', '3,4-methylenedioxymethamphetamine', 'functional magnetic resonance imaging (fMRI) following oral administration of 125\u2009mg MDMA']","['connectivity within two visual networks, the default mode network (DMN), and the sensorimotor network']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",45.0,0.080266,"Results revealed decreased connectivity within two visual networks, the default mode network (DMN), and the sensorimotor network.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4002, Switzerland. felix.mueller@upk.ch.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, 4031, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dolder', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, 4031, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, 4031, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, 4031, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Soltermann', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4002, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, 4031, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, 4002, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00906-2']
2746,32651307,Role of HSP90 in suppressing TLR4-mediated inflammation in ischemic postconditioning.,"BACKGROUND


Myocardial inflammation mediated by toll-like receptor 4 (TLR4) plays an active role in myocardial ischemia/reperfusion (I/R) injury. Studies show that heat shock protein 90 (HSP90) is involved in ischemic postconditioning (IPostC) cardioprotection. This study investigates the roles of TLR4 and HSP90 in IPostC.
METHODS


Rats were subjected to 30 min ischemia, then 2 h reperfusion. IPostC was applied by three cycles of 30 s reperfusion, then 30 s reocclusion at reperfusion onset. Sixty rats were randomly divided into four groups: sham, I/R, IPostC, and geldanamycin (GA, HSP90 inhibitor, 1 mg/kg) plus IPostC (IPostC + GA).
RESULTS


IPostC significantly reduced I/R-induced infarct size (40.2±2.1% versus 28.4±2.4%; P < 0.05); the release of cardiac Troponin T, creatine kinase-MB, and lactate dehydrogenase (191.5±3.1 versus 140.6±3.3 pg/ml, 3394.6±132.7 versus 2880.7±125.5 pg/ml, 2686.2±98.6 versus 1848.8±90.1 pg/ml, respectively; P < 0.05); and cardiomyocyte apoptosis (40.3±2.2% versus 27.0±1.6%; P < 0.05). Further, local and circulating IL-1β, IL-6, TNF-α, and ICAM-1 levels decreased; TLR4 expression and nuclear factor-KB (NF-κB) signaling decreased; and cardiac HSP90 expression increased. Blocking HSP90 function with GA inhibited IPostC protection and anti-inflammation, suggesting that IPostC has a HSP90-dependent anti-inflammatory effect.
CONCLUSION


HSP90 may play a role in IPostC-mediated cardioprotection by inhibiting TLR4 activation, local and systemic inflammation, and NF-kB signaling.",2020,"Further, local and circulating IL-1β, IL-6, TNF-α, and ICAM-1 levels decreased; TLR4 expression and nuclear factor-KB (NF-κB) signaling decreased; and cardiac HSP90 expression increased.","['Rats were subjected to 30\u200amin ischemia, then 2\u200ah reperfusion', 'Sixty rats']","['HSP90', 'geldanamycin', 'heat shock protein 90 (HSP90', 'GA, HSP90 inhibitor, 1\u200amg/kg) plus IPostC (IPostC\u200a+\u200aGA']","['infarct size', 'local and circulating IL-1β, IL-6, TNF-α, and ICAM-1 levels decreased; TLR4 expression and nuclear factor-KB (NF-κB) signaling decreased; and cardiac HSP90 expression', 'release of cardiac Troponin T, creatine kinase-MB, and lactate dehydrogenase', 'cardiomyocyte apoptosis']","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0243044', 'cui_str': 'Heat-Shock Proteins 90'}, {'cui': 'C0061179', 'cui_str': 'geldanamycin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936234', 'cui_str': 'Ischemic Post-Conditioning'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0243044', 'cui_str': 'Heat-Shock Proteins 90'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0225828', 'cui_str': 'Cardiac myocyte'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",60.0,0.106997,"Further, local and circulating IL-1β, IL-6, TNF-α, and ICAM-1 levels decreased; TLR4 expression and nuclear factor-KB (NF-κB) signaling decreased; and cardiac HSP90 expression increased.","[{'ForeName': 'Xin-Yue', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Guang Xi Medical University, Nanning, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Guang Xi Medical University, Nanning, China.'}, {'ForeName': 'Qing-Jie', 'Initials': 'QJ', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital, Guang Xi Medical University, Nanning, China.'}, {'ForeName': 'Guo-Qiang', 'Initials': 'GQ', 'LastName': 'Zhong', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Guang Xi Medical University, Nanning, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Meng', 'Affiliation': 'Geriatric Healthcare Center, First Affiliated Hospital, Guang Xi Medical University, Nanning, China.'}, {'ForeName': 'Dong-Xiao', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Guang Xi Medical University, Nanning, China.'}, {'ForeName': 'Rong-Hui', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Guang Xi Key Laboratory of Precision Medicine in Cardio-cerebrovascular Disease Control and Prevention, Nanning, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-200840']
2747,32681402,Factors Affecting Prescriber Implementation of Computer-Generated Medication Recommendations in the SENATOR Trial: A Qualitative Study.,"BACKGROUND


The SENATOR trial intervention included the provision of computer-generated medication recommendations to physician prescribers caring for hospitalised older adults (≥ 65 years), with the aim of reducing in-hospital adverse drug reactions. Interim data analysis during the trial revealed that the prescriber implementation rates of the computer-generated STOPP/START recommendations were lower than expected across all six trial sites.
AIM


The aim of this qualitative study was to identify the factors affecting prescriber implementation of the medication recommendations in the SENATOR trial.
METHODS


Semi-structured interviews were conducted with trial researchers and physician prescribers who were provided with SENATOR recommendations. Content analysis was used to identify the most relevant domains from the Theoretical Domains Framework (TDF) that affected recommendation uptake.
RESULTS


Ten trial researchers and fourteen prescribers were interviewed across the six trial sites. Eight TDF domains were found to be most relevant in affecting prescriber implementation: 'environmental context and resources', 'goals', 'intentions', 'knowledge', 'beliefs about consequences', 'memory, attention and decision processes', 'social/professional role and identity', and 'social influences'. Interviewees felt that there was often a disconnect between the time prescribers were reviewing the patient and the point at which the recommendations were provided. However, when recommendations were reviewed, prescriber inertia was highly pervasive, with a particular reluctance to make pharmacotherapy changes outside their own specialty. Implementation was facilitated by recommendations reaching a 'decision-maker', but this was often not possible as the software could not evaluate the entire clinical context of patients, and thus frequently produced recommendations of low clinical relevance.
CONCLUSION


This study has demonstrated that the clinical relevance of the SENATOR prescribing recommendations was a significant factor affecting their implementation. Whilst software refinement will be necessary to improve the quality of recommendations, future interventions will need to be multifaceted to overcome the complex prescriber specialty culture within the acute hospital environment.",2020,"Interim data analysis during the trial revealed that the prescriber implementation rates of the computer-generated STOPP/START recommendations were lower than expected across all six trial sites.
","['Semi-structured interviews were conducted with trial researchers and physician prescribers who were provided with SENATOR recommendations', 'hospitalised older adults (≥', 'Trial']",[],[],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],[],,0.0352045,"Interim data analysis during the trial revealed that the prescriber implementation rates of the computer-generated STOPP/START recommendations were lower than expected across all six trial sites.
","[{'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, Ireland. kieran.dalton@ucc.ie.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Medicine, University College Cork, Cork, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Cullinan', 'Affiliation': 'School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group, School of Pharmacy, University College Cork, Cork, Ireland.'}]",Drugs & aging,['10.1007/s40266-020-00787-6']
2748,31407421,Effects of jaw exercise intervention timing on outcomes following oral and oropharyngeal cancer surgery: Pilot study.,"BACKGROUND


Common in head and neck cancer patients, trismus can make speech and swallowing difficult and can compromise quality of life (QOL). Jaw range of motion exercise therapy may prevent or treat trismus in surgical patients. While the importance of these exercises is well-documented, there is little literature regarding the optimal timing of exercise initiation.
METHODS


A prospective pilot study investigated the effects of early vs late jaw exercise intervention on postoperative jaw opening and QOL measures, which were examined descriptively.
RESULTS


Timing of exercise intervention was not found to significantly impact the measured outcomes. However, provisional, descriptive findings showed that jaw opening was significantly associated with multiple QOL measures, with greater jaw opening associated with improved QOL. For certain QOL measures, this positive association was stronger at earlier time points than at later time points.
CONCLUSIONS


The exploratory findings of this pilot study support further research into possible benefits of early jaw exercise intervention.",2019,"However, provisional, descriptive findings showed that jaw opening was significantly associated with multiple QOL measures, with greater jaw opening associated with improved QOL.","['oral and oropharyngeal cancer surgery', 'surgical patients', 'head and neck cancer patients']","['exercise intervention', 'jaw exercise intervention', 'early jaw exercise intervention', 'early vs late jaw exercise intervention', 'motion exercise therapy']","['multiple QOL measures', 'QOL', 'postoperative jaw opening and QOL measures']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0175566', 'cui_str': 'Open'}]",,0.045013,"However, provisional, descriptive findings showed that jaw opening was significantly associated with multiple QOL measures, with greater jaw opening associated with improved QOL.","[{'ForeName': 'Mykayla L', 'Initials': 'ML', 'LastName': 'Sandler', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Cathy L', 'Initials': 'CL', 'LastName': 'Lazarus', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ru', 'Affiliation': 'Population Health Science & Policy, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kayvon F', 'Initials': 'KF', 'LastName': 'Sharif', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Yue', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Griffin', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Likhterov', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Chai', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Buchbinder', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Urken', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Ganz', 'Affiliation': 'THANC (Thyroid, Head and Neck Cancer) Foundation, New York, New York.'}]",Head & neck,['10.1002/hed.25908']
2749,31435980,Changing functional status within 6 months posttreatment is prognostic of overall survival in patients with head and neck cancer: NRG Oncology Study.,"BACKGROUND


Is posttreatment functional status prognostic of overall survival in patients with head and neck cancer (HNC).
METHODS


In an HNC clinical trial, 495 patients had two posttreatment functional assessments measuring diet, public eating, and speech within 6 months. Patients were grouped by impairment (highly, moderately, modestly, or not impaired) and determined if they improved, declined, or did not change from the first assessment to the second. Multivariable Cox models estimated overall mortality.
RESULTS


Across all three scales, the change in posttreatment patient function strongly predicted overall survival. In diet, patients who declined to highly impaired had three times the mortality of patients who were not impaired at both assessments (hazard ratio [HR] = 3.60; 95% confidence interval, 2.02-6.42). For patients improving from highly impaired, mortality was statistically similar to patients with no impairment (HR = 1.38; 95% CI, 0.82-2.31).
CONCLUSIONS


Posttreatment functional status is a strong prognostic marker of survival in patients with HNC.",2019,"For patients improving from highly impaired, mortality was statistically similar to patients with no impairment (HR = 1.38; 95% CI, 0.82-2.31).
","['495 patients had two posttreatment functional assessments measuring diet, public eating, and speech within 6\u2009months', 'patients with head and neck cancer (HNC', 'patients with head and neck cancer', 'patients with HNC']",[],"['overall survival', 'mortality']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0451169', 'cui_str': 'Functional assessment measure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",495.0,0.145451,"For patients improving from highly impaired, mortality was statistically similar to patients with no impairment (HR = 1.38; 95% CI, 0.82-2.31).
","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Eldridge', 'Affiliation': 'Emory University/Winship Cancer Center, Atlanta, Georgia.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Trotti', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Spencer', 'Affiliation': 'University of Alabama at Birmingham Medical Center, Birmingham, Alabama.'}, {'ForeName': 'Sue S', 'Initials': 'SS', 'LastName': 'Yom', 'Affiliation': 'UCSF Medical Center-Mount Zion, San Francisco, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenthal', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Akron City Hospital, Akron, Ohio.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gore', 'Affiliation': 'Zablocki VA Medical Center (Accruals under Froedtert and the Medical College of Wisconsin), Milwaukee, Wisconsin.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Shenouda', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Mishra', 'Affiliation': 'University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bruner', 'Affiliation': 'Emory University/Winship Cancer Center, Atlanta, Georgia.'}, {'ForeName': 'Canhua', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Emory University/Winship Cancer Center, Atlanta, Georgia.'}]",Head & neck,['10.1002/hed.25922']
2750,33216613,Comparative Effectiveness of Thai Herbal Formula (Thor-Ra-Nee-San-Tha-Kat) Versus Naproxen for Chronic Myofascial Pain: A Pilot Randomized-Controlled Trial.,"Background:  Myofascial pain syndrome (MPS) is a painful musculoskeletal condition. The prevalence of MPS ranges from 5.9% to 38.7% in the general population. ""Thor-ra-nee-san-tha-kat"" (TRK) is a traditional formula included in the Thailand National List of Essential Medicines for the treatment for muscle pain caused by abdominal rigidity and for severe constipation.  Objectives:  The authors employed a pilot single-blind, randomized-controlled trial to compare the effectiveness of TRK and naproxen for the treatment of chronic upper trapezius MPS.  Materials and Methods:  Seventy-six male and female subjects, ages 25-55 years, who met the inclusion criteria were equally randomized into two groups to receive either two 500 mg capsules of TRK once daily before bed or two 250 mg naproxen tablets twice a day after meals for 14 days. Subjects assessed their level of pain using the numerical rating scale. Cervical range of motion (CROM) was determined using a goniometer, and pressure pain threshold (PPT) was assessed using an algometer. Adverse drug reactions were recorded and all items were compared within and between groups, before and after treatment.  Results:  The results revealed that patient pain scores after 14 days of treatment were much improved with mean differences exceeding the reference minimum clinically important difference (MCID) in both groups. However, the changes in CROM and PPT values were small and did not surpass their respective reference MCIDs except for the right lateral bending CROM for naproxen treatment. The adverse drug reactions were mild, with watery stools reported by 47% of patients in the TRK-treated group and constipation reported by 24% of those in the naproxen group.  Conclusion:  The administration of TRK formula for 14 days was safe and as effective as naproxen at providing short-term relief of pain in patients with chronic upper trapezius pain.",2020,The administration of TRK formula for 14 days was safe and as effective as naproxen at providing short-term relief of pain in patients with chronic upper trapezius pain.,"['Chronic Myofascial Pain', 'Seventy-six male and female subjects, ages 25-55 years, who met the inclusion criteria', 'patients with chronic upper trapezius pain']","['naproxen tablets', 'naproxen', 'TRK', 'TRK and naproxen', 'Thai Herbal Formula', 'Naproxen', 'TRK formula']","['level of pain using the numerical rating scale', 'CROM and PPT values', 'Adverse drug reactions', 'adverse drug reactions', 'watery stools', 'Cervical range of motion (CROM', 'patient pain scores', 'constipation', 'prevalence of MPS ranges', 'pressure pain threshold (PPT']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1247066', 'cui_str': 'Naproxen Oral Tablet'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1292305', 'cui_str': 'Cromer blood group system'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",76.0,0.0767835,The administration of TRK formula for 14 days was safe and as effective as naproxen at providing short-term relief of pain in patients with chronic upper trapezius pain.,"[{'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Vichiansiri', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Nutjaree Pratheepawanit', 'Initials': 'NP', 'LastName': 'Johns', 'Affiliation': 'Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Amonwat', 'Initials': 'A', 'LastName': 'Thankham', 'Affiliation': 'Department of Thai Traditional Medicine, Faculty of Science, Udonthani Rajabhat University, Udonthani, Thailand.'}, {'ForeName': 'Tanit', 'Initials': 'T', 'LastName': 'Padumanonda', 'Affiliation': 'Division of Pharmacognosy and Toxicology, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0270']
2751,33217396,The impact of transfusions on mortality after transcatheter or surgical aortic valve replacement.,"BACKGROUND


An increasing body of evidence suggests that packed red blood cell (PRBC) transfusion may be associated with increased morbidity and mortality following transcatheter (TAVR) and surgical aortic valve replacement (SAVR). It remains unclear if PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality following aortic valve replacement in different populations.
METHODS


The SURTAVI trial randomized 1660 patients with symptomatic, severe aortic stenosis at intermediate risk for operative death to TAVR or SAVR. Baseline characteristics and outcomes including all-cause and cardiovascular mortality at 30 days and thereafter were compared between participants with and without PRBC transfusion. Cox proportional hazard models with time-varying covariates were fitted to estimate the effect of PRBC transfusion on mortality after adjustment for comorbidities and procedural complications.
RESULTS


Patients receiving PRBC were older, more commonly female and frail, with more comorbidities. Baseline STS PROM was higher in the transfused group. After adjustment for these differences, PRBC transfusion was associated with mortality at 30 days, but not thereafter. The effect of PRBC on mortality (HR 1.04 (95% CI: 0.96, 1.11); p=0.304) at 30 days was not independent of procedural complications (HR 21.04 (95% CI:7.26, 60.95); p<0.001).
CONCLUSIONS


Poor health status, procedural complications, PRBC transfusion and mortality are correlated with each other. PRBC transfusion did not independently increase risk for mortality. In this intermediate-risk population, transfusion appears to be a risk marker of chronic conditions and periprocedural complications as opposed to a risk factor for postprocedural mortality.",2020,"It remains unclear if PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality following aortic valve replacement in different populations.
","['1660 patients with symptomatic, severe aortic stenosis at intermediate risk for operative death to TAVR or SAVR']","['transcatheter or surgical aortic valve replacement', 'transcatheter (TAVR) and surgical aortic valve replacement (SAVR', 'PRBC']","['cardiovascular mortality', 'mortality', 'procedural complications', 'risk for mortality', 'Baseline STS PROM', 'procedural complications, PRBC transfusion and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C0199962', 'cui_str': 'Transfusion of packed red blood cells'}]",1660.0,0.14332,"It remains unclear if PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality following aortic valve replacement in different populations.
","[{'ForeName': 'Mubashir', 'Initials': 'M', 'LastName': 'Mumtaz', 'Affiliation': 'University of Pittsburgh Medical Center Pinnacle Heath, Cardiovascular and Thoracic Surgery, Harrisburg, PA. Electronic address: mmumtaz@pinnaclehealth.org.'}, {'ForeName': 'Moritz C', 'Initials': 'MC', 'LastName': 'Wyler von Ballmoos', 'Affiliation': 'Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Deeb', 'Affiliation': 'Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, MI.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gleason', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Iowa Heart Center, Des Moines, IA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hockmuth', 'Affiliation': 'Iowa Heart Center, Des Moines, IA.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Zorn', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tadros', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Clinical, Medtronic Plc, Mounds View, MN.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.09.031']
2752,33217416,Low-tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass in heart surgery (MECANO): a randomized controlled trial.,"BACKGROUND


Postoperative pulmonary complications are common after cardiac surgery and have been related to lung collapsus during cardiopulmonary bypass (CPB). There is no consensus on the effects of maintaining mechanical ventilation during CPB to decrease these complications.
RESEARCH QUESTION


To determine whether maintaining low-tidal ventilation (3 mL/kg 5 times per minute, with positive end expiratory pressure 5 cmH 2 O) during CPB (VENT strategy) was superior to a resting-lung strategy, with no ventilation (noV strategy), regarding postoperative pulmonary complications, including mortality.
STUDY DESIGN AND METHODS


In a randomized controlled trial, patients undergoing cardiac surgery at a single center from May 2017 to August 2019 were randomized between VENT and noV strategy during CPB (1:1 ratio). Apart from CPB phase, perioperative ventilation procedures were standardized.
RESULTS


The study included 1501 patients (68.8 ±10.3 years, 1152 (76.7%) men, EuroSCORE II 2.3 ±2.7). There were 756 patients in the VENT strategy group and there were no differences in baseline characteristics and types of procedures between the two groups. Intention-to-treat analysis yielded no significant difference between VENT and noV groups regarding incidence of the primary composite outcome combining death, early respiratory failure, ventilation support beyond day 2 and reintubation with 112/756, 14.8% in the VENT group versus 133/745, 17.9% in the noV group, odds-ratio(OR)=0.80 (95% confidence interval=0.61-1.05, p =0.11). Strict per-protocol analyses on 1338 (89.1%) patients with equally distributed preoperative characteristics yielded similar results (OR=0.81 (0.60-1.09), p=0.16). Post-hoc analysis on the subgroup of isolated coronary artery bypass graft (CABG) procedures (n=725), showed that VENT was superior to noV strategy regarding the primary outcome (OR=0.56 (0.37-0.84), p=0.005).
INTERPRETATION


Among patients undergoing cardiac surgery with CPB, continuation of low-tidal volume ventilation was not superior to no ventilation during CPB, with respect to postoperative complications, including death, early respiratory failure, ventilation support beyond day 2 and reintubation.",2020,"Intention-to-treat analysis yielded no significant difference between VENT and noV groups regarding incidence of the primary composite outcome combining death, early respiratory failure, ventilation support beyond day 2 and reintubation with 112/756, 14.8% in the VENT group versus 133/745, 17.9% in the noV group, odds-ratio(OR)=0.80 (95% confidence interval=0.61-1.05, p =0.11).","['patients undergoing cardiac surgery at a single center from May 2017 to August 2019 were randomized between VENT and noV strategy during CPB (1:1 ratio', 'patients undergoing cardiac surgery with CPB, continuation of low-tidal volume ventilation', 'heart surgery (MECANO', '1501 patients (68.8 ±10.3 years, 1152 (76.7%) men, EuroSCORE II 2.3 ±2.7']","['Low-tidal volume mechanical ventilation against no ventilation', 'maintaining low-tidal ventilation (3 mL/kg 5 times per minute, with positive end expiratory pressure 5 cmH 2 O) during CPB (VENT strategy', 'VENT']","['postoperative complications, including death, early respiratory failure, ventilation support beyond day 2 and reintubation', 'death, early respiratory failure, ventilation support beyond day 2 and reintubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}]",1501.0,0.293188,"Intention-to-treat analysis yielded no significant difference between VENT and noV groups regarding incidence of the primary composite outcome combining death, early respiratory failure, ventilation support beyond day 2 and reintubation with 112/756, 14.8% in the VENT group versus 133/745, 17.9% in the noV group, odds-ratio(OR)=0.80 (95% confidence interval=0.61-1.05, p =0.11).","[{'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Nguyen', 'Affiliation': 'Critical Care Department, CMC Ambroise Paré, Neuilly-sur-Seine, France; Research & Innovation Department of CMC Ambroise Paré (RICAP). Electronic address: nguyen.lee@icloud.com.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Estagnasie', 'Affiliation': 'Critical Care Department, CMC Ambroise Paré, Neuilly-sur-Seine, France; Research & Innovation Department of CMC Ambroise Paré (RICAP).'}, {'ForeName': 'Messaouda', 'Initials': 'M', 'LastName': 'Merzoug', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP).'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Brusset', 'Affiliation': 'Critical Care Department, CMC Ambroise Paré, Neuilly-sur-Seine, France; Research & Innovation Department of CMC Ambroise Paré (RICAP).'}, {'ForeName': 'Jean-Dominique', 'Initials': 'JD', 'LastName': 'Law Koune', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP); Anesthesiology Department, CMC Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Aubert', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP); Cardiothoracic Surgery Department, CMC Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Waldmann', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP); Cardiothoracic Surgery Department, CMC Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Naudin', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP).'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Grinda', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP); Cardiothoracic Surgery Department, CMC Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Hadrien', 'Initials': 'H', 'LastName': 'Gibert', 'Affiliation': 'Research & Innovation Department of CMC Ambroise Paré (RICAP); Anesthesiology Department, CMC Ambroise Paré, Neuilly-sur-Seine, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Squara', 'Affiliation': 'Critical Care Department, CMC Ambroise Paré, Neuilly-sur-Seine, France; Research & Innovation Department of CMC Ambroise Paré (RICAP).'}]",Chest,['10.1016/j.chest.2020.10.082']
2753,33217469,Micro-Computed Evaluation of Canal Transportation and Centring Ability of Five Rotary and Reciprocating Systems with Different Metallurgical Properties and Surface Treatments in Curved Root Canals.,"INTRODUCTION


The aim of this study was to evaluate the transportation and centring ability of five different rotary and reciprocating file systems with different metallurgical properties and surface treatments in curved root canals.
METHODS


Fifty mesiobuccal round canals of upper molars with cuvature of 25-40° were assigned to five experimental groups (n=12) according to the instrumentation system used: ProTaper Next (PTN); Reciproc Blue (RCB); Reciproc (RC); TruNatomy (TRN); XP-endo Shaper (XPS). During instrumentation, 5 mL of 2.5% NaOCl was used in each root canal. The final irrigation protocol included 15% ethylenediaminotetraacetic acid followed by NaOCl irrigation. The micro-CT scanning of the samples was performed before and after instrumentation to analyse the transportation and centring ability at three canal levels. The results were analysed with one-way ANOVA test with corresponding post hoc test.
RESULTS


Overall, RCB caused significantly more canal transportation compared to the other techniques (p<0.05). There were no significant differences between the other techniques (p>0.05). The PTN had a significantly better ability to stay within the central axis of the root canal compared to the RC and RCB techniques (p=0.046, p=0.017). In the apical third, all techniques caused similar apical transportation and centring ability (p>0.05). In the middle and cervical parts of the canal, the RCB caused a significantly greater canal transportation than other techniques (p<0.05).
CONCLUSIONS


Under the limitations of this study, all tested techniques had similar transportation and centring abilities in the apical part of the canal. However, overall results and those in the middle and coronal parts of the canal indicated that reciprocating instruments resulted in more canal transportation and less centred preparations.",2020,"The PTN had a significantly better ability to stay within the central axis of the root canal compared to the RC and RCB techniques (p=0.046, p=0.017).","['Curved Root Canals', 'Fifty mesiobuccal round canals of upper molars with cuvature of 25-40°']","['instrumentation system used: ProTaper Next (PTN); Reciproc Blue (RCB); Reciproc (RC); TruNatomy (TRN); XP-endo Shaper (XPS', 'ethylenediaminotetraacetic acid followed by NaOCl irrigation']",['canal transportation'],"[{'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}]","[{'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}]",,0.0206324,"The PTN had a significantly better ability to stay within the central axis of the root canal compared to the RC and RCB techniques (p=0.046, p=0.017).","[{'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Kabil', 'Affiliation': 'PhD student, School of Dental Medicine University of Zagreb, Croatia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Katić', 'Affiliation': 'Department of Quality - National Laboratory for Length, Faculty of Mechanical Engineering and Naval Architecture, University of Zagreb, Croatia.'}, {'ForeName': 'Ivica', 'Initials': 'I', 'LastName': 'Anić', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Croatia.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Bago', 'Affiliation': 'Department of Endodontics and Restorative Dentistry, School of Dental Medicine, University of Zagreb, Croatia. Electronic address: bago@sfzg.hr.'}]",Journal of endodontics,['10.1016/j.joen.2020.11.003']
2754,33217532,Effect of consumer's decisions on acrylamide exposure during the preparation of French fries. Part 1: frying conditions.,"Variability in home-cooking practices affects dietary exposure to acrylamide, limiting risk evaluation. Two observational tests (controlled and randomized) involving 127 volunteers was designed to investigate the influence of consumer decisions on acrylamide formation during the preparation of French fries. Consumer practices were recorded during pre-frying, frying and post-frying stages. Reducing sugar content, asparagine, moisture, acrylamide, moisture, weight loss and color were evaluated. In the controlled assay, mean acrylamide content was 508 μg/kg and volunteers took a mean frying time of 91.9 s (87.5-96.4, C.I. 95%). The narrow confidence interval of 8.9 s represented an increase of 120 μg/kg in the acrylamide content of the fried potato. Average acrylamide content in the randomized assay (215 μg/kg, 150-280 μg/kg, C.I. 95%) was significantly lower than in the controlled assay. Amongst the culinary practices applied for the potato variety evaluated, washing of the potato strips significantly reduced acrylamide content in French fries. The percentage of samples with acrylamide lower than the benchmark value (500 μg/kg) was 54% and 93% for the controlled and randomized assays, respectively. Estimated average dietary exposure to acrylamide from French fries in adults was 5.65 μg/day, which corresponds to a margin of exposure of 2105 for carcinogenicity.",2020,"Amongst the culinary practices applied for the potato variety evaluated, washing of the potato strips significantly reduced acrylamide content in French fries.","['127 volunteers', 'French fries']",[],"['Reducing sugar content, asparagine, moisture, acrylamide, moisture, weight loss and color', 'Average acrylamide content', 'mean acrylamide content']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1510451', 'cui_str': 'French fries'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0001218', 'cui_str': 'Acrylamides'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",127.0,0.0417331,"Amongst the culinary practices applied for the potato variety evaluated, washing of the potato strips significantly reduced acrylamide content in French fries.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mesias', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delgado-Andrade', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Holgado', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'González-Mulero', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Morales', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain. Electronic address: fjmorales@ictan.csic.es.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111857']
2755,33219482,"Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial.","PURPOSE


The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated.
METHODS


216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed.
RESULTS


Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present.
CONCLUSION


SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer.
TRIAL REGISTRATION NUMBER


ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040 ; retrospectively registered.",2020,"The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%.",['216 women aged 25-60\xa0years'],"['intravaginal daily dose of SAM gel', 'SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid', 'adsorbent and anti-oxidative vaginal gel', 'SAM vaginal gel']","['CIN lesions', 'p16/Ki-67 cytological test status', 'guided biopsy including p16 immunohistochemical (IHC) staining', 'Efficacy and safety', 'regression of cervical lesions and clears hr-HPV and p16/Ki-67', 'prevalence of hr-HPV']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0042257', 'cui_str': 'Vaginal gel'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0142923', 'cui_str': 'sodium selenite'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0350056', 'cui_str': 'Adsorbent agent'}]","[{'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205471', 'cui_str': 'Cytologic'}, {'cui': 'C0420636', 'cui_str': 'Test categorized by action status'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0235656', 'cui_str': 'Lesion of cervix'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",216.0,0.0880464,"The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%.","[{'ForeName': 'Attila Louis', 'Initials': 'AL', 'LastName': 'Major', 'Affiliation': 'Femina Gynecology Center, Rue Emile-Yung 1, 1205, Geneva, Switzerland. majorattila@outlook.fr.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Dvořák', 'Affiliation': 'Centrum ambulantní Gynekologie a primární péče, s.r.o., Brno, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schwarzová', 'Affiliation': ', Smetanova 388, 252 64 Velké Prilepy, Prague-West, Czech Republic.'}, {'ForeName': 'Aleš', 'Initials': 'A', 'LastName': 'Skřivánek', 'Affiliation': 'G-CENTRUM Olomouc, s.r.o., Olomouc, Czech Republic.'}, {'ForeName': 'Tomáš', 'Initials': 'T', 'LastName': 'Malík', 'Affiliation': 'Gyneko spol. s.r.o., Vsetin, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Pluta', 'Affiliation': 'Fakultní Nemocnice v Motole (University Hospital Motol), Onkogynekologická a kolposkopická Ambulance, Praha, Czech Republic.'}, {'ForeName': 'Ivanna', 'Initials': 'I', 'LastName': 'Mayboroda', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Etienne Marc', 'Initials': 'EM', 'LastName': 'Grandjean', 'Affiliation': 'Phidalsa Pharma-Consultants, Petit-Lancy/Geneva, Switzerland.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05816-8']
2756,33219500,"The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, an RCT.","Breast cancer ranks highest in incidence and mortality among females and second among both genders. Lebanon has the second highest rate of breast cancer worldwide for those 35-39 years old and the highest for those 40-49. Mastectomy often results in deceased shoulder and arm mobility and decreased quality of life. The objective of this study was to assess the effect of an educational program of therapeutic exercises on the quality of life and functional ability in women after a mastectomy. Sixty women undergoing a mastectomy were randomly assigned to either an intervention or control group. The intervention group received extensive pre-surgery education as well as training on therapeutic exercises. Follow-up phone calls to the intervention group were made to ensure that the exercises were being done. Both groups were visited at home at two and four weeks to obtain the outcome variables. The Breast Cancer Patient Version was used to assess quality of life, and the ""Goniometer"" was used to assess the range of motion of the affected shoulder. At two and four weeks after surgery, women in the intervention group had significant improvements in their shoulder range of motion: flexion, extension, and abduction were significantly different between the control and intervention group at p = 0.04-0.00. For quality of life, physical, psychological, psychological, social, and spiritual well-being were significantly higher for the intervention group at both two and four weeks after surgery, p < 0.001. In a middle-income country, one-to-one education provided by a nurse, which included demonstrations, back demonstrations, and weekly phone calls had a positive impact on women's shoulder range of motion and quality of life. NCT04184102.",2020,"For quality of life, physical, psychological, psychological, social, and spiritual well-being were significantly higher for the intervention group at both two and four weeks after surgery, p < 0.001.","['Sixty women undergoing a mastectomy', 'women after a mastectomy', 'Women After a Mastectomy, an RCT']","['Lebanon', 'Therapeutic Exercises', 'extensive pre-surgery education as well as training on therapeutic exercises', 'educational program of therapeutic exercises']","['Quality of Life and Shoulder Range of Motion', 'shoulder range of motion: flexion, extension, and abduction', 'quality of life', 'quality of life, physical, psychological, psychological, social, and spiritual well-being', 'quality of life and functional ability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}]","[{'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",60.0,0.0309159,"For quality of life, physical, psychological, psychological, social, and spiritual well-being were significantly higher for the intervention group at both two and four weeks after surgery, p < 0.001.","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Majed', 'Affiliation': 'Medical Surgical Unit, American University of Beirut Medical Center (AUBMC), Beirut, Lebanon.'}, {'ForeName': 'Charlene A', 'Initials': 'CA', 'LastName': 'Neimi', 'Affiliation': 'California State University Channel Islands, Camarillo, CA, USA.'}, {'ForeName': 'Sawsan Moustafa', 'Initials': 'SM', 'LastName': 'Youssef', 'Affiliation': 'Medical-Surgical Nursing Faculty of Health Sciences, Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Khaled Ahmed', 'Initials': 'KA', 'LastName': 'Takey', 'Affiliation': 'Beirut Arab University, Beirut, Lebanon.'}, {'ForeName': 'Lina Kurdahi', 'Initials': 'LK', 'LastName': 'Badr', 'Affiliation': 'School of Nursing, Azusa Pacific University, Azusa, CA, 91702, USA. lbadr@apu.edu.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01894-z']
2757,33152158,Robot-assisted fluoroscopy-guided renal puncture for endoscopic combined intrarenal surgery: a pilot single-centre clinical trial.,,2020,,[],"['Robot-assisted fluoroscopy-guided renal puncture', 'endoscopic combined intrarenal surgery']",[],[],"[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.107592,,"[{'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Taguchi', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Shuzo', 'Initials': 'S', 'LastName': 'Hamamoto', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Taiki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Iwatsuki', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Etani', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yasui', 'Affiliation': 'Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",BJU international,['10.1111/bju.15291']
2758,32507902,The rapid N-wave as a potentially useful measure of the photopic negative response.,"PURPOSE


The photopic negative response (PhNR) correlates with ganglion cell function and has previously been examined as an indicator of glaucomatous optic nerve damage. However, it is a prolonged response that is measured against baseline, and its clinical utility has been limited by extensive variability, poor repeatability, and baseline instability. We have observed a distinct brief negative wave (""N-wave"") commonly present within the slow PhNR trough, which may provide practical and analytic advantages as a clinical measure.
METHODS


We reviewed data from an interventional trial of 59 glaucoma patients who had 4 exams over an 8-month period. The PhNR was recorded with standard ISCEV stimuli (1 Hz and in some cases 4 Hz stimulation), and N-waves were measured manually, relative to return to baseline.
RESULTS


N-waves, when present, could be measured easily despite shifting baselines and a degree of background noise. The PhNR median amplitude centered around 18 μV, while the N-wave median centered around 7 μV, with a distribution of responses skewed toward low or zero amplitudes.
CONCLUSIONS


The N-wave appears to be a component of the longer PhNR, though its exact origin and significance remain unclear. As a rapid waveform that is independent of baseline, the N-wave is in many ways easier to measure accurately than the slower PhNR, which is highly dependent on baseline stability. The N-wave may prove useful clinically if further studies can optimize its stimulation, show its behavior in normal individuals and find correlation with markers of optic nerve disease.",2020,"As a rapid waveform that is independent of baseline, the N-wave is in many ways easier to measure accurately than the slower PhNR, which is highly dependent on baseline stability.",['59 glaucoma patients who had 4 exams over an 8-month period'],[],[],"[{'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],[],59.0,0.0732049,"As a rapid waveform that is independent of baseline, the N-wave is in many ways easier to measure accurately than the slower PhNR, which is highly dependent on baseline stability.","[{'ForeName': 'Brandon H', 'Initials': 'BH', 'LastName': 'Pham', 'Affiliation': 'Stanford University School of Medicine, 291 Campus Drive, Li Ka Shing Building, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Goldberg', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute at Stanford, 2452 Watson Court, Palo Alto, CA, 94303, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Marmor', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute at Stanford, 2452 Watson Court, Palo Alto, CA, 94303, USA. marmor@stanford.edu.'}]",Documenta ophthalmologica. Advances in ophthalmology,['10.1007/s10633-020-09769-w']
2759,32605387,Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy.,"BACKGROUND


Mild heart failure (HF) patients without left bundle branch block (LBBB) did not derive a significant reduction in risk of a HF event/death in the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). However, the efficacy of CRT with a defibrillator (CRT-D) may be modified after the development of the first hospitalization for HF (HHF). We aimed to study the effect of CRT-D on long-term risk of recurrent HHF in patients without LBBB in MADIT-CRT.
METHODS


Data on recurring HHF were collected for 1818 subjects. The CRT-D versus implantable cardioverter-defibrillator-only risk for first and subsequent HHF was assessed by QRS morphology in on-treatment analysis using Cox proportional hazards regression modeling.
RESULTS


During long-term follow-up, 412 patients had ≥1 HHF and 333 had ≥2 HHF. Multivariate analysis revealed that in LBBB patients, CRT-D, compared with implantable cardioverter-defibrillator, was associated with a significant reduction in risk of first and subsequent HHF (first: hazard ratio, 0.41 [95% CI, 0.31-0.54],  P <0.001; subsequent: hazard ratio, 0.45 [95% CI, 0.29-0.70],  P <0.001). Among patients without LBBB, the benefit of CRT-D was nonsignificant for the first HHF (hazard ratio, 0.96;  P =0.808). However, after occurrence of a first HHF, CRT-D therapy was associated with a pronounced 44% reduction in risk of subsequent HHF (hazard ratio, 0.56 [95% CI, 0.32-0.97],  P =0.039). Patients without LBBB with ≥1 HHF during the first year of follow-up demonstrated increasing dyssynchrony at 1 year compared with those who had no HHF ( P =0.016).
CONCLUSIONS


In MADIT-CRT, we show a beneficial effect of CRT-D in patients without LBBB subsequent to development of a first HHF, possibly due to increased dyssynchrony associated with HF progression. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00180271, NCT01294449, and NCT02060110.",2020,"During long-term follow-up, 412 patients had ≥1 HHF and 333 had ≥2 HHF.","['patients without LBBB in MADIT-CRT.\nMETHODS\n\n\nData on recurring HHF were collected for 1818 subjects', '412 patients had ≥1 HHF and 333 had ≥2 HHF', 'Patients Without Left Bundle Branch Block', 'Mild heart failure (HF) patients without left bundle branch block (LBBB']","['CRT', 'CRT-D', 'Cardiac Resynchronization Therapy']","['dyssynchrony', 'risk of first and subsequent HHF', 'benefit of CRT-D', 'risk of subsequent HHF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006384', 'cui_str': 'Bundle branch block'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}]","[{'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}]",1818.0,0.133047,"During long-term follow-up, 412 patients had ≥1 HHF and 333 had ≥2 HHF.","[{'ForeName': 'Himabindu', 'Initials': 'H', 'LastName': 'Vidula', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aktas', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Rosero', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Arwa', 'Initials': 'A', 'LastName': 'Younis', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (S.D.S.).""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY (H.V., E.L., S.M., B.P., M.A., S.R., A.Y., W.Z., V.K., I.G.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.120.006925']
2760,33216782,Ultrasound-guided internal branch of superior laryngeal nerve block on postoperative sore throat: A randomized controlled trial.,"INTRODUCTION


Ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block) have been used to decrease the perioperative stress response of intubation. It is more likely to be successful than blindly administered superior laryngeal nerve blocks with fewer complications. Here, we evaluated the efficacy of USG-guided iSLN block to treat postoperative sore throat (postoperative sore throat, POST) after extubation.
METHODS


100 patients, aged from 18 to 60 years old, ASA I~II who underwent general anesthesia and suffered from the moderate to severe postoperative sore throat after extubation were randomized into two groups(50 cases per group). Patients in group S received USG-guided iSLN block bilaterally (60mg of 2% lidocaine, 1.5ml each side), whereas those in group I received inhalation with 100 mg of 2% lidocaine and 1mg of budesonide suspension diluted with normal saline (oxygen flow 8 L /min, inhalation for 15 minutes). The primary outcome were VAS scores in both groups before treatment (T0), 10 min (T1), 30 min(T2), 1h(T3), 2 h(T4), 4h(T5), 8h(T6), 24h(T7), and 48h(T8) after treatment. The secondary outcome were satisfaction scores after treatment, MAP, HR, and SPO2 fromT0 to T8. The adverse reactions such as postoperative chocking or aspiration, cough, hoarseness, dyspnea were also observed in both groups.
RESULTS


Patients in group S had significantly lower VAS score than that in group I at points of T1 ~ T6 (P < 0.01). HR of group S was lower than that of group I at points of T1 ~ T2and T4 (P < 0.05), and MAP was lower than that of group I at points of T1 ~ T3 (P < 0.05). Satisfaction scores of group S were higher than that of group I (P <0.05), In group S, 2 case (4%) needed to intravenous Flurbiprofen Injection 50 mg to relieve pain; in group I, 13 cases (26%) received Flurbiprofen Injection. 2 case of group S appeared throat numbness after treatment for 3 hours; 2 patients have difficult in expectoration after treatment recovered after 3hour. No serious adverse events were observed in both groups.
CONCLUSION


Compared with inhalation, USG-guided iSLN block may effectively relieve the postoperative sore throat after extubation under general anesthesia and provided an ideal treatment for POST in clinical work.",2020,"Satisfaction scores of group S were higher than that of group I (P <0.05),","['100 patients, aged from 18 to 60 years old, ASA I~II who underwent general anesthesia and suffered from the moderate to severe postoperative sore throat after extubation']","['inhalation with 100 mg of 2% lidocaine and 1mg of budesonide suspension diluted with normal saline (oxygen flow 8 L /min, inhalation', 'inhalation, USG-guided iSLN block', 'Flurbiprofen', 'Ultrasound-guided internal branch of the upper laryngeal nerve block (USG-guided iSLN block', 'Ultrasound-guided internal branch of superior laryngeal nerve block', 'Flurbiprofen Injection', 'USG-guided iSLN block bilaterally (60mg of 2% lidocaine', 'USG-guided iSLN block']","['satisfaction scores after treatment, MAP, HR, and SPO2 fromT0 to T8', 'throat numbness', 'MAP', 'serious adverse events', 'Satisfaction scores', 'relieve pain', 'adverse reactions such as postoperative chocking or aspiration, cough, hoarseness, dyspnea', 'VAS scores', '10 min (T1), 30 min(T2), 1h(T3), 2 h(T4), 4h(T5), 8h(T6), 24h(T7), and 48h(T8', 'postoperative sore throat', 'VAS score']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0016377', 'cui_str': 'Flurbiprofen'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0394816', 'cui_str': 'Local anesthetic block of laryngeal nerve'}, {'cui': 'C0394817', 'cui_str': 'Local anesthetic superior laryngeal nerve block'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C1168343', 'cui_str': 'Numbness throat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",100.0,0.0629822,"Satisfaction scores of group S were higher than that of group I (P <0.05),","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhipeng', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Meiyi', 'Affiliation': 'Department of Anesthesia, ChanCheng Center Hospital, Foshan, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Meirong', 'Affiliation': 'Department of Anesthesia, ChanCheng Center Hospital, Foshan, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Qunmeng', 'Affiliation': 'Department of Anesthesia, ChanCheng Center Hospital, Foshan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhenhua', 'Affiliation': 'Department of Anesthesia, ChanCheng Center Hospital, Foshan, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Yuezhen', 'Affiliation': 'Department of Anesthesia, ChanCheng Center Hospital, Foshan, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Jinfang', 'Affiliation': 'Key Laboratory of Orthopaedics & Traumatology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Chuiliang', 'Affiliation': 'Department of Anesthesia, ChanCheng Center Hospital, Foshan, China.'}]",PloS one,['10.1371/journal.pone.0241834']
2761,33216791,Risk-guided maternity care to enhance maternal empowerment postpartum: A cluster randomized controlled trial.,"OBJECTIVE


To investigate whether a structured inquiry during pregnancy of medical factors and social factors associated with low socioeconomic status, and subsequent patient-centred maternity care could increase maternal empowerment.
DESIGN


Cluster-randomised controlled trial.
SETTING


This study was conducted among pregnant women in selected urban areas in the Netherlands. This study was part of the nationwide Healthy Pregnancy 4 All-2 programme.
POPULATION


Pregnant women listed at one of the sixteen participating maternity care organisations between July 1, 2015, and Dec 31, 2016.
METHODS


All practices were instructed to provide a systematic risk assessment during pregnancy. Practices were randomly allocated to continue usual care (seven practices), or to provide a patient-centred, risk-guided approach to addressing any risks (nine practices) identified via the risk assessment during pregnancy.
MAIN OUTCOME MEASURES


Low postpartum maternal empowerment score.
RESULTS


We recruited 1579 participants; 879 participants in the intervention arm, and 700 participants in the control arm. The prevalence of one or more risk factors during pregnancy was similar between the two arms: 40% and 39%, respectively. In our intention-to-treat analysis, the intervention resulted in a significant reduction in the odds of having a low empowerment score [i.e. the primary outcome; adjusted OR 0.69 ((95% CI 0.47; 0.99), P 0.046)].
CONCLUSIONS


Implementation of additional risk assessment addressing both medical and social factors and subsequent tailored preventive strategies into maternity care reduced the incidence of low maternal empowerment during the postpartum period. Introducing this approach in routine maternity care may help reduce early adversity during the postpartum period.",2020,"The prevalence of one or more risk factors during pregnancy was similar between the two arms: 40% and 39%, respectively.","['nationwide Healthy Pregnancy 4 All-2 programme', 'pregnant women in selected urban areas in the Netherlands', 'Pregnant women listed at one of the sixteen participating maternity care organisations between July 1, 2015, and Dec 31, 2016', 'We recruited 1579 participants; 879 participants in the intervention arm, and 700 participants in the control arm']","['continue usual care (seven practices), or to provide a patient-centred, risk-guided approach to addressing any risks (nine practices) identified via the risk assessment during pregnancy', 'Risk-guided maternity care to enhance maternal empowerment postpartum']","['odds of having a low empowerment score', 'low maternal empowerment', 'Low postpartum maternal empowerment score']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",1579.0,0.120563,"The prevalence of one or more risk factors during pregnancy was similar between the two arms: 40% and 39%, respectively.","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lagendijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Meertien K', 'Initials': 'MK', 'LastName': 'Sijpkens', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Hiske E', 'Initials': 'HE', 'LastName': 'Ernst-Smelt', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Verbiest', 'Affiliation': 'UNC School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Jasper V', 'Initials': 'JV', 'LastName': 'Been', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}]",PloS one,['10.1371/journal.pone.0242187']
2762,33216879,Cardiovascular Benefits of Angiotensin Converting Enzyme Inhibition plus Calcium Channel Blockade in Patients Achieving Tight Blood Pressure Control and with Resistant Hypertension.,"BACKGROUND


The 2017 hypertension guidelines lowered systolic blood pressure goals to <130 mm Hg and re-defined resistant hypertension. We investigated if these changes alter the cardiovascular benefits demonstrated by combining a calcium channel blocker, rather than hydrochlorthiazide, with an angiotensin converting enzyme inhibitor.
METHODS


In this post hoc analysis of the ACCOMPLISH trial (n=11,506), we compared the primary composite outcome (cardiovascular death, myocardial infarction, stroke, hospitalization for angina, resuscitation after sudden cardiac death, and coronary revascularization) between the 2 combination-treatment limbs in patients achieving a systolic blood pressure ≤130 mm Hg and those with ""apparent resistant hypertension"" (prescribed ≥4 antihypertensive medications).
RESULTS


Among study patients, 5221 (45.4%) achieved a systolic blood pressure ≤130 mm Hg. There were fewer primary endpoints in the amlodipine/benazepril (9.2%) versus the hydrochlorothiazide/benazepril (10.9%) limb (adjusted hazard ratio 0.83; 95% confidence interval, 0.70 to 0.99). There were also fewer primary endpoints in the amlodipine/benazepril (12.8%) versus the hydrochlorothiazide/benazepril (15.2%) limb (n=4451, 38.7%) among patients with apparent resistant hypertension (hazard ratio 0.81, 95% confidence interval, 0.70-0.95). Most individual outcomes did not significantly differ between treatment limbs, given reduced power, but many trended to favor amlodipine/benazepril.
CONCLUSIONS


Combination therapy adding a calcium channel blocker, rather than hydrochlorothiazide, to an angiotensin converting enzyme inhibitor was more effective in preventing composite cardiovascular events even in hypertensive patients achieving aggressive systolic blood pressure targets as well as in those with apparent resistant hypertension. Our findings add support that most patients, including those following contemporary clinical guidelines, will benefit from this combination.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT00170950.",2020,"Most individual outcomes did not significantly differ between treatment limbs, given reduced power, but many trended to favor amlodipine/benazepril.
","['Patients Achieving Tight Blood Pressure Control and with Resistant Hypertension', 'hypertensive patients', '≤130']","['amlodipine/benazepril', 'hydrochlorothiazide', 'hydrochlorothiazide/benazepril', 'Angiotensin Converting Enzyme Inhibition plus Calcium Channel Blockade']","['cardiovascular benefits', 'systolic blood pressure', 'systolic blood pressure goals', 'primary composite outcome (cardiovascular death, myocardial infarction, stroke, hospitalization for angina, resuscitation after sudden cardiac death, and coronary revascularization', 'systolic blood pressure ≤130']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0717411', 'cui_str': 'Amlodipine- and benazepril-containing product'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0053091', 'cui_str': 'benazepril'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006685', 'cui_str': 'Calcium Channel'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",11506.0,0.260342,"Most individual outcomes did not significantly differ between treatment limbs, given reduced power, but many trended to favor amlodipine/benazepril.
","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Center for Human Growth and Development and Department of Biostatistics, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Dahlöf', 'Affiliation': 'Sahlgrenska University Hospital Östra, Göthenburg, Sweden.'}, {'ForeName': 'Bertrtam', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Velazquez', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'State University of New York Downstate, Brooklyn, NY.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Jamerson', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of hypertension,['10.1093/ajh/hpaa192']
2763,33216969,Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic non-commercial multicentre randomised open label parallel group medical device trial.,"BACKGROUND


Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs).
OBJECTIVES


Determine if silicone foam dressings in addition to standard prevention reduce PU incidence category 2 or worse compared to standard prevention alone.
METHODS


Multicentre, randomised controlled, medical device trial conducted in eight Belgian hospitals. At risk adult patients were centrally randomised (n=1633) to study groups based on a 1:1:1 allocation: experimental group 1 (n=542) and 2 (n=545) - pooled as the treatment group - and the control group (n=546). Experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on these body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU category 2 or worse at these body sites.
RESULTS


In the intention-to-treat population (n=1605); 4.0% of patients developed PUs category 2 or worse in the treatment group and 6.3% in the control group (RR=0.64, 95% CI 0.41 to 0.99, P=0.04). Sacral PUs were observed in 2.8% and 4.8% of the patients in the treatment group and the control group, respectively (RR=0.59, 95% CI 0.35 to 0.98, P=0.04). Heel PUs occurred in 1.4% and 1.9% of patients in the treatment and control group respectively (RR=0.76, 95% CI 0.34 to 1.68, P=0.49).
CONCLUSIONS


Silicone foam dressings reduce the incidence of PUs category 2 or worse in hospitalised at-risk patients when used in addition to standard of care. Results show a decrease for sacrum, but no statistical difference for heel/trochanter areas.",2020,"Heel PUs occurred in 1.4% and 1.9% of patients in the treatment and control group respectively (RR=0.76, 95% CI 0.34 to 1.68, P=0.49).
","['At risk adult patients', 'eight Belgian hospitals']","['standard of care', 'PU prevention', 'Silicone adhesive multilayer foam dressings']","['hospital-acquired pressure ulcers', 'Sacral PUs', 'Heel PUs', 'incidence of a new PU category 2 or worse at these body sites']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}]","[{'cui': 'C2959937', 'cui_str': 'Hospital acquired pressure ulcer'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0558158', 'cui_str': 'Pressure ulcer of heel'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C2945842', 'cui_str': 'Associated topography'}]",,0.0847518,"Heel PUs occurred in 1.4% and 1.9% of patients in the treatment and control group respectively (RR=0.76, 95% CI 0.34 to 1.68, P=0.49).
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Beeckman', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fourie', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Raepsaet', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Van Damme', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Manderlier', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Meyer', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Beele', 'Affiliation': 'Wound Care Centre, Ghent University, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Smet', 'Affiliation': 'Wound Care Centre, Ghent University, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Demarré', 'Affiliation': 'AZ Sint-Elisabeth, Zottegem, Oost-Vlaanderan, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vossaert', 'Affiliation': 'AZ Sint-Elisabeth, Zottegem, Oost-Vlaanderan, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Graaf', 'Affiliation': 'Wound Care Support Team, Nursing Centre of Excellence, University Hospitals of Leuven, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Verhaeghe', 'Affiliation': 'AZ Maria Middelares, Ghent, Belgium.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vandergheynst', 'Affiliation': 'AZ Maria Middelares, Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hendrickx', 'Affiliation': 'University Hospital of Brussel (UZB), Department of Plastic Surgery, Brussel, Belgium.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hanssens', 'Affiliation': 'University Hospital of Brussel (UZB), Department of Plastic Surgery, Brussel, Belgium.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Keymeulen', 'Affiliation': 'OLV Ziekenhuis Aalst, Aalst, Oost-Vlaanderan, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Vanderwee', 'Affiliation': 'OLV van Lourdes Ziekenhuis Waregem, Waregem, West-Vlaanderan, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Van De Woestijne', 'Affiliation': 'AZ Groeninge, Kortrijk, West-Vlaanderan, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Verhaeghe', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Van Hecke', 'Affiliation': 'Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Savoye', 'Affiliation': 'Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Harrison', 'Affiliation': 'Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vrijens', 'Affiliation': 'Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Hulstaert', 'Affiliation': 'Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.'}]",The British journal of dermatology,['10.1111/bjd.19689']
2764,33217060,Radiographic changes in height and volume after lateral GBR procedures with different ratios of deproteinized bovine bone mineral and autogenous bone at different time points. An experimental study.,"OBJECTIVE


Estimate changes in augmentation height and volume after lateral guided bone regeneration (GBR) augmentation with different ratios of deproteinized bovine bone mineral (DBBM) and particulate autogenous bone (PAB) and autogenous bone block (ABB), at different time points.
MATERIAL AND METHODS


Twenty-four minipigs were randomly allocated into three heling periods. Lateral augmentation in 96 sites with standardized quantity of graft material was performed with different ratios of DBBM and PAB (50:50, 75:25 and 100:0) and ABB in combination with DBBM, covered by a collagen membrane. Changes in augmentation height and volume were assessed on CT volumes acquired 10, 20, and 30 weeks after surgery.
RESULTS


Reduction in bone augmentation height was: 50:50 - 1.7 mm (-33.1%), 75:25 - 1.8 mm (-37.8%), 100:0 - 1.7 mm (-35.8%), and ABB - 0.2 mm (-3.7%), after 30 weeks. The augmentation height was significantly better preserved with ABB compared to 50:50, 75:25, and 100:0, while no significant difference was present among particulate grafts. No significant difference in volumetric reduction was found among 50:50, 75:25, 100:0 and ABB after 30 weeks, while 100:0 presented significant less reduction compared to 50:50, 75:25 and ABB after 10 and 20 weeks.
CONCLUSIONS


Augmentation height following GBR was better preserved with ABB covered with DBBM. Addition of PAB to DBBM did not affect the changes in height of the graft. The volumetric stability seems to be comparable for ABB covered by DBBM and all particulate grafts after 30 weeks. However, DBBM alone revealed significant less volume reduction in the early healing phase.",2020,"RESULTS


Reduction in bone augmentation height was: 50:50 - 1.7 mm (-33.1%), 75:25 - 1.8 mm (-37.8%), 100:0 - 1.7 mm (-35.8%), and ABB - 0.2 mm (-3.7%), after 30 weeks.",['Twenty-four minipigs'],[],"['volumetric reduction', 'height of the graft', 'augmentation height', 'bone augmentation height', 'deproteinized bovine bone mineral (DBBM) and particulate autogenous bone (PAB) and autogenous bone block (ABB']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}]",[],"[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}]",24.0,0.0345933,"RESULTS


Reduction in bone augmentation height was: 50:50 - 1.7 mm (-33.1%), 75:25 - 1.8 mm (-37.8%), 100:0 - 1.7 mm (-35.8%), and ABB - 0.2 mm (-3.7%), after 30 weeks.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Aludden', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Department of Clinical Medicine, The Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Mordenfeld', 'Affiliation': 'Plastic and Oral & Maxillofacial Surgery, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Cederlund', 'Affiliation': 'Departmen of oral radiology, Eastman Institute, Stockholm county council, Region Stockholm, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Dahlin', 'Affiliation': 'Department of Biomaterials, BIOMATCELL VINN Excellence center, Institute for Surgical Science, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Spin-Neto', 'Affiliation': 'Department of Dentistry and Oral Health, Section of Oral Radiology, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Veiss-Pedersen', 'Affiliation': 'Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Babyasha', 'Initials': 'B', 'LastName': 'Sritharan', 'Affiliation': 'Unit of Clinical Biostatistics, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Starch-Jensen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Department of Clinical Medicine, The Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}]",Clinical oral implants research,['10.1111/clr.13687']
2765,33217070,A Pilot Study of Mobilized Intervention to Help Caregivers of Oncology Patients Manage Distress.,"BACKGROUND


OBJECTIVE: Caregivers of patients with advanced cancer experience significant anxiety, depression, and distress. Caregivers have barriers to accessing in-person treatment to manage stress. Technology allows for the dissemination of evidence-based interventions in a convenient way. This study examined usage rates of Pep-Pal (an evidence-based mobilized intervention to help caregivers of patients with advanced cancer manage distress) and estimates of efficacy on anxiety, depression, stress, and sexual dysfunction.
METHODS


Fifty-six primary caregivers of patients with advanced cancer were recruited through oncology clinics and randomized to either Pep-Pal (a mobilized psychoeducation and skills-based intervention for caregivers, n= 26) or treatment as usual (TAU, n= 30). All were screened for moderate anxiety on the HADS-A screening assessment (A ≥ 8) at baseline.
RESULTS


Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS F = 3.91, p=.05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU. Of Pep-Pal participants, only 10 (38.5%) watched at least 7/9 full-length sessions. The a priori hypothesis and criterion that participants would watch at least 75% full-length sessions were not met.
CONCLUSIONS


A brief, easily disseminated mobile intervention showed poor adherence, but had limited estimates of efficacy for secondary outcomes; perceived stress, learning stress management skills, and sexual functioning (women only). Future directions are discussed. This article is protected by copyright. All rights reserved.",2020,"RESULTS


Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS F = 3.91, p=.05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU.","['Help Caregivers of Oncology Patients Manage Distress', 'patients with advanced cancer manage distress', 'patients with advanced cancer experience significant anxiety, depression, and distress', 'Fifty-six primary caregivers of patients with advanced cancer were recruited through oncology clinics and randomized to either']","['Mobilized Intervention', 'Pep-Pal (a mobilized psychoeducation and skills-based intervention for caregivers, n= 26) or treatment as usual (TAU, n= 30', 'Pep-Pal (an evidence-based mobilized intervention']","['ability to learn and use stress management skills', 'sexual function', 'perceived stress', 'anxiety, depression, stress, and sexual dysfunction', 'stress, learning stress management skills, and sexual functioning']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",56.0,0.0626445,"RESULTS


Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS F = 3.91, p=.05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU.","[{'ForeName': 'Nicole Amoyal', 'Initials': 'NA', 'LastName': 'Pensak', 'Affiliation': 'Atlantic Coast Mind & Body, Red Bank, NJ.'}, {'ForeName': 'Alaina L', 'Initials': 'AL', 'LastName': 'Carr', 'Affiliation': 'University of Colorado-Denver, Denver, CO.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'College of Nursing, University of Colorado Anschutz Medical Campus (UCAMC), Aurora, CO.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Mikulich-Gilbertson', 'Affiliation': 'Department of Psychiatry, UCAMC, Aurora, CO.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine (DOM), UCAMC, Aurora, CO.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kilbourn', 'Affiliation': 'University of Colorado-Denver, Denver, CO.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Sannes', 'Affiliation': 'Department of Psychiatry, UCAMC, Aurora, CO.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brewer', 'Affiliation': 'Division of Hematology, DOM, UCAMC, Aurora, CO.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Kolva', 'Affiliation': 'Division of Medical Oncology, DOM, UCAMC, Aurora, CO.'}, {'ForeName': 'Tanisha', 'Initials': 'T', 'LastName': 'Joshi', 'Affiliation': 'Division of Hematology, DOM, UCAMC, Aurora, CO.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Laudenslager', 'Affiliation': 'Department of Psychiatry, UCAMC, Aurora, CO.'}]",Psycho-oncology,['10.1002/pon.5597']
2766,33217092,Glycemic control with add-on thiazolidinedione or sodium glucose co-transporter 2 inhibitor in type 2 diabetes mellitus patients after failure of an oral triple antidiabetic regimen: A 24-week randomized controlled trial.,"AIMS


There is growing evidence of the efficacy of quadruple combination therapy in type 2 diabetes (T2D). We aimed to evaluate the effectiveness and safety of adding either a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or thiazolidinedione (TZD) in patients with T2D inadequately controlled with triple therapy.
MATERIALS AND METHODS


In this prospective, open-label, multicenter, 24-week clinical trial, we randomly assigned 119 patients with T2D who failed to achieve glycemic control (7%< glycated hemoglobin (HbA1c) ≤ 10%) with conventional triple oral antidiabetic agents (OADs; metformin, sulfonylurea, and dipeptidyl peptide 4 (DPP-4) inhibitor) into two groups who received an SGLT2i or TZD. The primary endpoint was mean change in HbA1c level between the two groups at 24 weeks.
RESULTS


In total, 119 patients were enrolled in the SGLT2i (n=60) and TZD (n =59) groups. Mean age of the study subjects was 61.86 years, and mean duration of T2D was 13.89 years. After 24 weeks, both groups demonstrated significant reductions in HbA1c (from 7.94±0.74 to 6.97±0.84% in the SGLT2i group and 8.00±0.78 to 7.18±0.98% in the TZD group), without a significant between-group difference (p=0.235). A significant body mass index reduction was noted in the SGLT2i group, whereas an increase in BMI was noted in the TZD group (-0.79 ± 1.37 vs. 0.92 ± 0.86, p<0.001). Other safety profiles were favorable in both groups.
CONCLUSIONS


The present study demonstrates that SGLT2i or TZD could be valid option as fourth OAD for treatment of patients with T2D inadequately controlled with triple OADs. This article is protected by copyright. All rights reserved.",2020,"After 24 weeks, both groups demonstrated significant reductions in HbA1c (from 7.94±0.74 to 6.97±0.84% in the SGLT2i group and 8.00±0.78 to 7.18±0.98% in the TZD group), without a significant between-group difference (p=0.235).","['type 2 diabetes (T2D', 'patients with T2D inadequately controlled with triple therapy', '119 patients were enrolled in the SGLT2i (n=60) and TZD (n =59) groups', 'Mean age of the study subjects was 61.86\u2009years, and mean duration of T2D was 13.89\u2009years', 'patients with T2D inadequately controlled with triple OADs', '119 patients with T2D who failed to achieve glycemic control (7%< glycated hemoglobin (HbA1c) ≤\u200910%) with', 'type 2 diabetes mellitus patients after failure of an oral triple antidiabetic regimen']","['conventional triple oral antidiabetic agents (OADs; metformin, sulfonylurea, and dipeptidyl peptide 4 (DPP-4) inhibitor', 'Glycemic control with add-on thiazolidinedione or sodium glucose co-transporter 2 inhibitor', 'sodium-glucose cotransporter 2 inhibitor (SGLT2i) or thiazolidinedione (TZD', 'TZD', 'SGLT2i', 'SGLT2i or TZD']","['HbA1c', 'BMI', 'effectiveness and safety', 'body mass index reduction', 'mean change in HbA1c level']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",119.0,0.0524917,"After 24 weeks, both groups demonstrated significant reductions in HbA1c (from 7.94±0.74 to 6.97±0.84% in the SGLT2i group and 8.00±0.78 to 7.18±0.98% in the TZD group), without a significant between-group difference (p=0.235).","[{'ForeName': 'Jaehyun', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Catholic Kwandong University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Huh', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Ho', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Byung-Wan', 'Initials': 'BW', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14259']
2767,33217109,Remediation of a Phonological Representation Deficit in Chinese Children with Dyslexia: A Comparison between Metalinguistic Training and Working Memory Training.,"A form-preparation task in the language production field was adopted to examine output phonological representations in Chinese dyslexia and their susceptibility to training. Forty-one Chinese children with dyslexia (7-11 years old) and thirty-six chronological age controls completed this task. The controls demonstrated a marginally significant syllable facilitation effect (d = -0.13), indicating their use of syllable-sized phonological representations during speech production, while the group with dyslexia showed a significantly different pattern (d = 0.04), opposite to the direction of a facilitation effect. The children with dyslexia were then randomly assigned to either metalinguistic training (N = 22) or working memory training (N = 19). Only the metalinguistic training subgroup demonstrated a significant syllable facilitation effect afterward (metalinguistic: d = -0.13; working memory: d = -0.01). The results suggest the presence of a phonological representation deficit at the syllable level in Chinese dyslexia and its possible remediation by metalinguistic training. Such a phonological deficit in readers of a logographic script strongly supports the impaired phonological representations view of developmental dyslexia.",2020,"The controls demonstrated a marginally significant syllable facilitation effect (d = -0.13), indicating their use of syllable-sized phonological representations during speech production, while the group with dyslexia showed a significantly different pattern (d = 0.04), opposite to the direction of a facilitation effect.","['children with dyslexia', 'Forty-one Chinese children with dyslexia (7-11 years old) and thirty-six chronological age controls completed this task', 'Chinese Children with Dyslexia']","['metalinguistic training', 'Metalinguistic Training and Working Memory Training', 'working memory training']","['syllable-sized phonological representations during speech production', 'syllable facilitation effect']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",41.0,0.0163833,"The controls demonstrated a marginally significant syllable facilitation effect (d = -0.13), indicating their use of syllable-sized phonological representations during speech production, while the group with dyslexia showed a significantly different pattern (d = 0.04), opposite to the direction of a facilitation effect.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, The Education University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Ka Chun', 'Initials': 'KC', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Wai Leung', 'Initials': 'WL', 'LastName': 'Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Tik Sze Carrey', 'Initials': 'TSC', 'LastName': 'Siu', 'Affiliation': 'Department of Early Childhood Education, The Education University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McBride', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Kevin Kien Hoa', 'Initials': 'KKH', 'LastName': 'Chung', 'Affiliation': 'Department of Early Childhood Education, The Education University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Patrick C M', 'Initials': 'PCM', 'LastName': 'Wong', 'Affiliation': 'Brain and Mind Institute, The Chinese University of Hong Kong, Hong Kong S.A.R., China.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Maurer', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Hong Kong S.A.R., China.'}]",Developmental science,['10.1111/desc.13065']
2768,33217117,Add-on Therapy with Dapagliflozin under Full Closed Loop Control improves Time in Range in Adolescents and young Adults with Type 1 Diabetes- The DAPADream Study.,"OBJECTIVE


The aim of this trial was to investigate the effect of the SGLT2-inhibitor dapagliflozin on glucose levels overnight and during the following day after two unannounced meals under full closed loop (FCL) conditions.
STUDY DESIGN


For this single-center, double-blind, randomized, placebo-controlled cross-over trial, non-obese persons with type 1 diabetes (T1D) were studied twice (10 mg dapagliflozin bid vs. placebo) for 24 hours with two unannounced mixed meal tests 6 hours apart under FCL conditions. Primary outcome was sensor glucose Time in Range (3.9-10 mmol/l, TIR). For safety evaluation, ß-hydroxybutyrate (BHB), glucagon, insulin, and gastric inhibitory polypeptide were measured.
RESULTS


15 adolescents [age 15.4±1.6 years, diabetes duration 10.0±3.4 years, HbA1c 8.4±0.9 % (67.7± 10.1 mmol/mol Hb)] and 15 young adults [18.7±0.8; 12.5±3.6; 8.3±0.9 % ( 68.5±11.2 mmol/mol Hb)] completed the trial. TIR was significantly higher in the intervention group compared to placebo (68%±6% vs. 50%±13%, p<0.001); nocturnal glucose was significantly lower with dapagliflozin (6.2±0.7 vs. 7.3±1.7 mmol/l; p=0.003) without an increase in time < 3.9 mmol/l (3.3±6.0 vs 3.1±5.2 % p=0.75). Urinary glucose excretion was increased threefold using dapagliflozin (149±42 vs. 49±23 g/24h) with a total insulin reduction of 22% (39.7±12.7 U vs. 30.6±10.4 U, p=0.004). No abnormal elevated BHB-values were observed.
CONCLUSIONS


In adolescents and adults with T1D, dapagliflozin increased significantly TIR on average by 259 min/day while reducing glycemic variability during FCL without any signs for hypoglycemia or ketosis. This article is protected by copyright. All rights reserved.",2020,"TIR was significantly higher in the intervention group compared to placebo (68%±6% vs. 50%±13%, p<0.001); nocturnal glucose was significantly lower with dapagliflozin (6.2±0.7 vs. 7.3±1.7 mmol/l; p=0.003) without an increase in time < 3.9 mmol/l (3.3±6.0 vs 3.1±5.2 % p=0.75).","['15 adolescents [age 15.4±1.6\u2009years, diabetes duration 10.0±3.4\u2009years, HbA1c 8.4±0.9 % (67.7±\u200910.1\u2009mmol/mol Hb)] and 15 young adults', 'obese persons with type 1 diabetes (T1D', 'Adolescents and young Adults with Type 1 Diabetes']","['Dapagliflozin', 'dapagliflozin', 'dapagliflozin bid vs. placebo', 'SGLT2-inhibitor dapagliflozin', 'placebo']","['TIR', 'Urinary glucose excretion', 'nocturnal glucose', 'glycemic variability', 'abnormal elevated BHB-values', 'For safety evaluation, ß-hydroxybutyrate (BHB), glucagon, insulin, and gastric inhibitory polypeptide', 'sensor glucose Time in Range (3.9-10\u2009mmol/l, TIR']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]",,0.436792,"TIR was significantly higher in the intervention group compared to placebo (68%±6% vs. 50%±13%, p<0.001); nocturnal glucose was significantly lower with dapagliflozin (6.2±0.7 vs. 7.3±1.7 mmol/l; p=0.003) without an increase in time < 3.9 mmol/l (3.3±6.0 vs 3.1±5.2 % p=0.75).","[{'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Muller', 'Affiliation': 'DreaMed Diabetes Ltd, Petah Tikva, Israel.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'dem Berge', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Atlas', 'Affiliation': 'DreaMed Diabetes Ltd, Petah Tikva, Israel.'}, {'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Centre for Childhood Diabetes, Schneider Children's Medical Centre of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, UMC - University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Bratina', 'Affiliation': ""Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, UMC - University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, UMC - University Children's Hospital, Ljubljana, Slovenia.""}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus Auf der Bult, Hannover, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14258']
2769,32693653,Topical anaesthesia as an adjuvant to local anaesthetic injection in open trigger digit release: a randomized controlled trial.,"We conducted a randomized controlled trial to compare pain scores and patient satisfaction between topical anaesthetic cream (5% lidocaine-prilocaine cream) versus placebo cream, applied approximately 90 minutes before local anaesthetic injection for open trigger digit release. One hundred participants were enrolled and randomly allocated into the two groups between May 2019 and February 2020. The visual analogue pain scores and satisfaction scores were measured. Most participants were female with Quinnell Grade 2-3 trigger digits. The pain scores during needle injection, local anaesthetic infiltration, the overall pain and satisfaction scores had no statistically significant differences between groups. There was no correlation between duration of topical anaesthetic drug application and pain scores. Subgroup analysis did not show significant differences in pain scores between genders. No complications were found during the study period. The topical anaesthetic drug was ineffective to use on the palmar skin during open trigger digit release surgery. Level of evidence:  II.",2020,"The pain scores during needle injection, local anaesthetic infiltration, the overall pain and satisfaction scores had no statistically significant differences between groups.","['One hundred participants were enrolled and randomly allocated into the two groups between May 2019 and February 2020', 'Most participants were female with Quinnell Grade 2-3 trigger digits']","['topical anaesthetic cream (5% lidocaine-prilocaine cream', 'placebo cream', 'Topical anaesthesia']","['duration of topical anaesthetic drug application and pain scores', 'pain scores', 'pain scores and patient satisfaction', 'visual analogue pain scores and satisfaction scores', 'local anaesthetic infiltration, the overall pain and satisfaction scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}]","[{'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.254486,"The pain scores during needle injection, local anaesthetic infiltration, the overall pain and satisfaction scores had no statistically significant differences between groups.","[{'ForeName': 'Panai', 'Initials': 'P', 'LastName': 'Laohaprasitiporn', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Yuwarat', 'Initials': 'Y', 'LastName': 'Monteerarat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Roongsak', 'Initials': 'R', 'LastName': 'Limthongthang', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Torpon', 'Initials': 'T', 'LastName': 'Vathana', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Vajara', 'Initials': 'V', 'LastName': 'Wilairatana', 'Affiliation': 'Department of Orthopaedic Surgery, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420939494']
2770,33217221,"Comparative analysis of outcomes and long-term follow-up of robot-assisted pediatric kidney transplantation, with open counterpart.","How does the robotic kidney transplant fare against the open technique, in pediatric patients? No one knows. To address this question, this study compares the outcomes of robotic kidney transplants, with those of open transplant in these patients. This study was a retrospective analysis of outcomes (renal function and complications), of all pediatric patients (<18 years of age), who underwent kidney transplant at our institute, after 2014, till their last follow-up. Fisher's exact test was used to compare proportions. Continuous variables were analyzed using Mann-Whitney test. P value of <.05 was considered significant. Of the twenty-five patients included, 21 belonged to open group, and 4 to the robotic group. Patients in the robotic group had significantly higher Re-WIT (P value .002) and had lower analgesia requirement (P value .04). Median follow-up period was 31 months. Both groups were comparable in terms of length of hospital stay, blood transfusion, and renal function post-operatively till their last follow-up. Three patients in the open group had surgical site infection as compared to none in the robotic group. All the patients had functioning grafts till their last follow-up. Robotic transplant is safe and delivers functional results similar to open technique, with lesser pain and better cosmesis. Longer Re-WIT in robotic transplant has no impact on post-operative renal function. Ours is the first known effort to compare robotic technology with the established open technique of transplant in this population. A prospective randomized controlled trial should refine the results of the present study.",2020,Patients in the robotic group had significantly higher Re-WIT (P value .002) and had lower analgesia requirement (P value .04).,"['all pediatric patients (<18\xa0years of age), who underwent kidney transplant at our institute, after 2014, till their last follow-up']","['robot-assisted pediatric kidney transplantation, with open counterpart', 'robotic kidney transplants']","['length of hospital stay, blood transfusion, and renal function post-operatively till their last follow-up', 'Re-WIT', 'analgesia requirement', 'surgical site infection']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0043197', 'cui_str': 'Wit as Topic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}]",,0.0208472,Patients in the robotic group had significantly higher Re-WIT (P value .002) and had lower analgesia requirement (P value .04).,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Uro-oncology, Renal Transplant and Robotics, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Maheshwari', 'Affiliation': 'Department of Urology, Uro-oncology, Renal Transplant and Robotics, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Samit', 'Initials': 'S', 'LastName': 'Chaturvedi', 'Affiliation': 'Department of Urology, Uro-oncology, Renal Transplant and Robotics, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Devanshu', 'Initials': 'D', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Uro-oncology, Renal Transplant and Robotics, Max Super Specialty Hospital, New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, Uro-oncology, Renal Transplant and Robotics, Max Super Specialty Hospital, New Delhi, India.'}]",Pediatric transplantation,['10.1111/petr.13917']
2771,33217236,The Benefit of Perineural Injection Treatment with Dextrose for Treatment of Chondromalacia Patella in Participants Receiving Home Physical Therapy: A Pilot Randomized Clinical Trial.,"Introduction:  Chondromalacia patella is the degeneration of articular cartilage on the posterior facet of the patella and may indicate the onset of osteoarthritis. Conservative management is the main treatment option, and surgical intervention is considered the last option in a small percentage of patients. Perineural Injection Treatment (PIT) is a recently developed treatment option that is directed adjacent to the peripheral nerves that are the source of pathology causing neurogenic inflammation and pain.  Objective:  The objective of this study was to evaluate the efficacy of PIT combined with a home physical therapy program in patients with a diagnosis of chondromalacia patella compared with a control group receiving physical therapy only.  Methods:  Two patient groups were involved in this randomized clinical trial. The first received PIT combined with physical therapy (PIT + PT group) and the second was managed with physical therapy alone (PT group). Both groups were indicated to follow a 6-week home therapy plan afterward. The Western Ontario and McMaster Osteoarthritis Index was used to assess the patients at baseline and 6 months after therapy interventions.  Results:  Fifty patients (38 women and 12 men, median age 54.7 ± 14.8 years) were included; sex distribution and age did not differ between groups. Both groups had chondromalacia grade II or III, but the degree of gonarthrosis did not differ significantly between groups. The PIT + PT group outperformed PT group for pain (7.3 ± 3.5 vs. 3.2 ± 2.9 points;  p  < 0.010), stiffness (3 ± 1.69 vs. 1.6 ± 1.5 points;  p  < 0.010), and functional capacity (23.2 ± 10.7 vs. 11.1 ± 8.9 points;  p  < 0.010).  Conclusions:  Compared with physical therapy alone, PIT plus physical therapy reduced pain and stiffness and restored functional capacity. ClinicalTrials.gov Register Number #NCT03515720.",2020,"Both groups had chondromalacia grade II or III, but the degree of gonarthrosis did not differ significantly between groups.","['Participants Receiving Home Physical Therapy', 'Fifty patients (38 women and 12 men, median age 54.7\u2009±\u200914.8 years) were included; sex distribution and age did not differ between groups', 'patients with a diagnosis of chondromalacia patella compared with a control group receiving physical therapy only']","['Dextrose', 'Perineural Injection Treatment (PIT', 'PIT combined with physical therapy (PIT + PT group) and the second was managed with physical therapy alone (PT group', 'physical therapy alone, PIT plus physical therapy', 'PIT combined with a home physical therapy program']","['Western Ontario and McMaster Osteoarthritis Index', 'degree of gonarthrosis', 'pain and stiffness and restored functional capacity', 'functional capacity']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036878', 'cui_str': 'Sex Distribution'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008475', 'cui_str': 'Chondromalacia of patella'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175697', 'cui_str': 'Van der Woude syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",50.0,0.0530492,"Both groups had chondromalacia grade II or III, but the degree of gonarthrosis did not differ significantly between groups.","[{'ForeName': 'Sandra Angélica', 'Initials': 'SA', 'LastName': 'García-Triana', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'María Fernanda', 'Initials': 'MF', 'LastName': 'Toro-Sashida', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Xóchilt Verónica', 'Initials': 'XV', 'LastName': 'Larios-González', 'Affiliation': 'Physical Medicine and Rehabilitation Unit, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Fuentes-Orozco', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mares-País', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Barbosa-Camacho', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Bertha Georgina', 'Initials': 'BG', 'LastName': 'Guzmán-Ramírez', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Kevin Josue', 'Initials': 'KJ', 'LastName': 'Pintor-Belmontes', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Dinorah', 'Initials': 'D', 'LastName': 'Rodríguez-Navarro', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Irma Valeria', 'Initials': 'IV', 'LastName': 'Brancaccio-Pérez', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Esparza-Estrada', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Bernal-Hernández', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-Ojeda', 'Affiliation': 'Biomedical Research Unit 02, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute, Guadalajara, México.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0287']
2772,33217335,Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial.,"BACKGROUND


Patients with type 2 diabetes and atherosclerotic cardiovascular disease are at high clinical risk. We assessed the effect of the sodium-glucose co-transporter-2 inhibitor, empagliflozin, on total cardiovascular events and admissions to hospital in the EMPA-REG OUTCOME trial.
METHODS


The EMPA-REG OUTCOME trial was a randomised, double-blind, non-inferiority trial of patients (aged ≥18 years) with type 2 diabetes and atherosclerotic cardiovascular disease done between August, 2010, and April, 2015. Participants were randomly assigned (1:1:1) to empagliflozin 10 mg or 25 mg, or placebo. The primary outcome was major adverse cardiovascular events: a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction. As prespecified, the effects of pooled empagliflozin versus placebo were assessed on total (first plus recurrent) events of major adverse cardiovascular events, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, and admission to hospital for heart failure. We also did post-hoc analyses on additional cardiovascular and admission to hospital outcomes. We used statistical models that preserve randomisation and account for correlation of recurrent events, including negative binomial regression, as prespecified for the primary analyses. The EMPA-REG OUTCOME trial is registered with ClinicalTrials.gov, NCT01131676, and is closed to accrual.
FINDINGS


In the EMPA-REG OUTCOME trial, 7020 patients were randomly assigned and treated with empagliflozin 10 mg (n=2345), empagliflozin 25 mg (n=2342), or placebo (n=2333) and followed up for a median of 3·2 years (IQR 2·2 to 3·6) in the pooled empagliflozin group and 3·1 years (2·2 to 3·5) in the placebo group. Analysing total (first plus recurrent) events, empagliflozin versus placebo reduced the risk of major adverse cardiovascular events (rate ratio [RR] 0·78 [95% CI 0·67 to 0·91]; p=0·0020; 12·88 [95% CI 3·74 to 22·02] events prevented per 1000 patient-years); fatal or non-fatal myocardial infarction (0·79 [0·62 to 0·998]; p=0·049; 4·97 [-0·68 to 10·61] events prevented per 1000 patient-years); the composite of fatal or non-fatal myocardial infarction, or coronary revascularisation (0·80 [0·67 to 0·95]; p=0·012; 11·65 [1·25 to 22·05] events prevented per 1000 patient-years); admission to hospital for heart failure (0·58 [0·42 to 0·81]; p=0·0012; 9·67 [3·07 to 16·28] events prevented per 1000 patient-years); and all-cause admission to hospital (0·83 [0·76 to 0·91]; p<0·0001; 50·41 [26·20 to 74·63] events prevented per 1000 patient-years). For outcomes significantly reduced with empagliflozin, risk reductions were numerically larger for total events than for first events. Total fatal or non-fatal stroke was not significantly different between treatment groups (RR 1·10 [95% CI 0·82 to 1·49]; p=0·52).
INTERPRETATION


Empagliflozin reduced the total burden of cardiovascular complications and all-cause admission to hospital in patients with type 2 diabetes and atherosclerotic cardiovascular disease.
FUNDING


The Boehringer Ingelheim and Lilly Alliance.",2020,"Total fatal or non-fatal stroke was not significantly different between treatment groups (RR 1·10 [95% CI 0·82 to 1·49]; p=0·52).
","['per 1000 patient-years); admission to hospital for heart failure (0·58 [0·42 to 0·81]; p=0·0012; 9·67 [3·07 to 16·28] events prevented per 1000 patient-years); and all-cause admission to hospital (0·83', 'patients (aged ≥18 years) with type 2 diabetes and atherosclerotic cardiovascular disease done between August, 2010, and April, 2015', 'Patients with type 2 diabetes and atherosclerotic cardiovascular disease', '7020 patients', '11·65', '0·67 to 0·95', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease']","['empagliflozin', 'placebo', 'sodium-glucose co-transporter-2 inhibitor, empagliflozin', 'pooled empagliflozin versus placebo', 'empagliflozin 10 mg or 25 mg, or placebo', 'coronary revascularisation (0·80', 'Empagliflozin']","['major adverse cardiovascular events: a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction', '22·02] events prevented per 1000 patient-years); fatal or non-fatal myocardial infarction', 'total (first plus recurrent) events of major adverse cardiovascular events, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, and admission to hospital for heart failure', 'Total fatal or non-fatal stroke', 'total cardiovascular events and admissions to hospital', 'total burden of cardiovascular complications', 'risk of major adverse cardiovascular events']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",7020.0,0.225562,"Total fatal or non-fatal stroke was not significantly different between treatment groups (RR 1·10 [95% CI 0·82 to 1·49]; p=0·52).
","[{'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Parkland Health and Hospital System, Dallas, TX, USA. Electronic address: darren.mcguire@utsouthwestern.edu.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma, Ingelheim, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Elsasser', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hantel', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Søren S', 'Initials': 'SS', 'LastName': 'Lund', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30344-2']
2773,33217362,"Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial.","BACKGROUND


With the unprecedented morbidity and mortality associated with the COVID-19 pandemic, a vaccine against COVID-19 is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity.
METHODS


In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18-59 years were recruited from the community in Suining County of Jiangsu province, China. Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded. The experimental vaccine for the phase 1 trial was manufactured using a cell factory process (CellSTACK Cell Culture Chamber 10, Corning, Wujiang, China), whereas those for the phase 2 trial were produced through a bioreactor process (ReadyToProcess WAVE 25, GE, Umea, Sweden). The phase 1 trial was done in a dose-escalating manner. At screening, participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants were assigned to block 1 (low dose CoronaVac [3 μg per 0·5 mL of aluminium hydroxide diluent per dose) then another 36 were assigned to block 2 (high-dose Coronavc [6 μg per 0·5 mL of aluminium hydroxide diluent per dse]). Within each block, participants were randomly assigned (2:1), using block randomisation with a block size of six, to either two doses of CoronaVac or two doses of placebo. In the phase 2 trial, at screening, participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants were randomly assigned (2:2:1), using block randomisation with a block size of five, to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. Participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after injection in all participants who were given at least one dose of study drug (safety population). The primary immunogenic outcome was seroconversion rates of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 cohort, and at day 28 after the last dose in the days 0 and 28 cohort in participants who completed their allocated two-dose vaccination schedule (per-protocol population). This trial is registered with ClinicalTrials.gov, NCT04352608, and is closed to accrual.
FINDINGS


Between April 16 and April 25, 2020, 144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial. 743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population). In the phase 1 trial, the incidence of adverse reactions for the days 0 and 14 cohort was seven (29%) of 24 participants in the 3 ug group, nine (38%) of 24 in the 6 μg group, and two (8%) of 24 in the placebo group, and for the days 0 and 28 cohort was three (13%) of 24 in the 3 μg group, four (17%) of 24 in the 6 μg group, and three (13%) of 23 in the placebo group. The seroconversion of neutralising antibodies on day 14 after the days 0 and 14 vaccination schedule was seen in 11 (46%) of 24 participants in the 3 μg group, 12 (50%) of 24 in the 6 μg group, and none (0%) of 24 in the placebo group; whereas at day 28 after the days 0 and 28 vaccination schedule, seroconversion was seen in 20 (83%) of 24 in the 3 μg group, 19 (79%) of 24 in the 6 μg group, and one (4%) of 24 in the placebo group. In the phase 2 trial, the incidence of adverse reactions for the days 0 and 14 cohort was 40 (33%) of 120 participants in the 3 μg group, 42 (35%) of 120 in the 6 μg group, and 13 (22%) of 60 in the placebo group, and for the days 0 and 28 cohort was 23 (19%) of 120 in the 3 μg group, 23 (19%) of 120 in the 6 μg group, and 11 (18%) of 60 for the placebo group. Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.
INTERPRETATION


Taking safety, immunogenicity, and production capacity into account, the 3 μg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials.
FUNDING


Chinese National Key Research and Development Program and Beijing Science and Technology Program.",2020,"Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.
","['Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded', 'healthy adults aged 18-59 years', '144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial', '743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population', 'healthy adults aged 18-59 years were recruited from the community in Suining County of Jiangsu province, China', 'Between April 16 and April 25, 2020', 'participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants', 'participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants']","['low-dose CoronaVac, high-dose CoronaVac, or placebo', 'placebo', 'inactivated SARS-CoV-2 vaccine', 'aluminium hydroxide diluent per dose', 'aluminium hydroxide', 'block 1 (low dose CoronaVac [3 μg per 0·5']","['Safety, tolerability, and immunogenicity', 'seroconversion rates of neutralising antibodies to live SARS-CoV-2', 'seroconversion of neutralising antibodies', 'Seroconversion of neutralising antibodies', 'incidence of adverse reactions', 'adverse reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C1531924', 'cui_str': 'Axillary temperature'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",144.0,0.639885,"Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group, and none (0%) of 59 in the placebo group.
","[{'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Microbiology, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Weixiao', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Sinovac Biotech, Beijing, China.'}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Congbing', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Minnan', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'CAS Key Laboratory of Infection and Immunity, National Laboratory of Macromolecules, Institute of Biophysics, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Suining County Center for Disease Control and Prevention, Suining, Jiangsu Province, China.'}, {'ForeName': 'Xiangxi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'CAS Key Laboratory of Infection and Immunity, National Laboratory of Macromolecules, Institute of Biophysics, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Sinovac Life Sciences, Beijing, China. Electronic address: gaoq@sinovac.com.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30843-4']
2774,33217361,"Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial.","BACKGROUND


To address the unmet medical need for an effective prophylactic vaccine against Ebola virus we assessed the safety and immunogenicity of three different two-dose heterologous vaccination regimens with a replication-deficient adenovirus type 26 vector-based vaccine (Ad26.ZEBOV), expressing Zaire Ebola virus glycoprotein, and a non-replicating, recombinant, modified vaccinia Ankara (MVA) vector-based vaccine, encoding glycoproteins from Zaire Ebola virus, Sudan virus, and Marburg virus, and nucleoprotein from the Tai Forest virus.
METHODS


This randomised, observer-blind, placebo-controlled, phase 2 trial was done at seven hospitals in France and two research centres in the UK. Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts. Participants in cohorts I-III were randomly assigned (1:1:1) using computer-generated randomisation codes into three parallel groups (randomisation for cohorts II and III was stratified by country and age), in which participants were to receive an intramuscular injection of Ad26.ZEBOV on day 1, followed by intramuscular injection of MVA-BN-Filo at either 28 days (28-day interval group), 56 days (56-day interval group), or 84 days (84-day interval group) after the first vaccine. Within these three groups, participants in cohort II (14:1) and cohort III (10:3) were further randomly assigned to receive either Ad26.ZEBOV or placebo on day 1, followed by either MVA-BN-Filo or placebo on days 28, 56, or 84. Participants in cohort IV were randomly assigned (5:1) to receive one dose of either Ad26.ZEBOV or placebo on day 1 for vector shedding assessments. For cohorts II and III, study site personnel, sponsor personnel, and participants were masked to vaccine allocation until all participants in these cohorts had completed the post-MVA-BN-Filo vaccination visit at 6 months or had discontinued the trial, whereas cohort I was open-label. For cohort IV, study site personnel and participants were masked to vaccine allocation until all participants in this cohort had completed the post-vaccination visit at 28 days or had discontinued the trial. The primary outcome, analysed in all participants who had received at least one dose of vaccine or placebo (full analysis set), was the safety and tolerability of the three vaccination regimens, as assessed by participant-reported solicited local and systemic adverse events within 7 days of receiving both vaccines, unsolicited adverse events within 42 days of receiving the MVA-BN-Filo vaccine, and serious adverse events over 365 days of follow-up. The secondary outcome was humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies at 21 days after receiving the MVA-BN-Filo vaccine. The secondary outcome was assessed in the per-protocol analysis set. This study is registered at ClinicalTrials.gov, NCT02416453, and EudraCT, 2015-000596-27.
FINDINGS


Between June 23, 2015, and April 27, 2016, 423 participants were enrolled: 408 in cohorts I-III were randomly assigned to the 28-day interval group (123 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo), and 15 participants in cohort IV were assigned to receive Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo (n=2). 421 (99·5%) participants received at least one dose of vaccine or placebo. The trial was temporarily suspended after two serious neurological adverse events were reported, one of which was considered as possibly related to vaccination, and per-protocol vaccination was disrupted for some participants. Vaccinations were generally well tolerated. Mild or moderate local adverse events (mostly pain) were reported after 206 (62%) of 332 Ad26.ZEBOV vaccinations, 136 (58%) of 236 MVA-BN-Filo vaccinations, and 11 (15%) of 72 placebo injections. Systemic adverse events were reported after 255 (77%) Ad26.ZEBOV vaccinations, 116 (49%) MVA-BN-Filo vaccinations, and 33 (46%) placebo injections, and included mostly mild or moderate fatigue, headache, or myalgia. Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections. At 21 days after receiving the MVA-BN-Filo vaccine, geometric mean concentrations of Ebola virus glycoprotein-binding antibodies were 4627 ELISA units (EU)/mL (95% CI 3649-5867) in the 28-day interval group, 10 131 EU/mL (8554-11 999) in the 56-day interval group, and 11 312 mL (9072-14106) in the 84-day interval group, with antibody concentrations persisting at 1149-1205 EU/mL up to day 365.
INTERPRETATION


The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo was safe, well tolerated, and immunogenic, with humoral and cellular immune responses persisting for 1 year after vaccination. Taken together, these data support the intended prophylactic indication for the vaccine regimen.
FUNDING


Innovative Medicines Initiative and Janssen Vaccines & Prevention BV.",2020,"Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections.","['participants in cohort II (14:1) and cohort III (10:3', 'adults in Europe (EBOVAC2', 'Participants in cohorts', 'Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts', 'seven hospitals in France and two research centres in the UK', '423 participants were enrolled: 408 in cohorts I-III', 'Between June 23, 2015, and April 27, 2016', '15 participants in cohort IV']","['heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen', 'Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo', 'placebo', 'Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo', 'MVA-BN-Filo or placebo', 'vaccine or placebo', 'Ad26.ZEBOV or placebo']","['Systemic adverse events', 'solicited local and systemic adverse events', 'safety and tolerability', 'serious adverse events', 'Mild or moderate local adverse events (mostly pain', 'Safety and immunogenicity', 'Unsolicited adverse events', 'moderate fatigue, headache, or myalgia', 'humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies', 'tolerated']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0282687', 'cui_str': 'Ebola virus disease'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042214', 'cui_str': 'Vaccinia'}, {'cui': 'C1449556', 'cui_str': 'Ebolavirus Vaccines'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0949892', 'cui_str': 'Ebolavirus'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",423.0,0.596138,"Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, INSERM CIC 1417, F-CRIN I-REIVAC, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, CIC Cochin Pasteur, Paris, France.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelievre', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France; Assistance Publique-Hôpitaux de Paris, Groupe Henri-Mondor Albert-Chenevier, Service Immunologie Clinique, Créteil, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Grande', 'Affiliation': 'Allergology and Clinical Immunology, LYREC, Lyon University Hospital, France.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Goldstein', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Auguste', 'Initials': 'A', 'LastName': 'Gaddah', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Viki', 'Initials': 'V', 'LastName': 'Bockstal', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Leyssen', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luhn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Richert', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bétard', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.'}, {'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Levy', 'Affiliation': 'Vaccine Research Institute, Faculté de Médecine, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Macaya', 'Initials': 'M', 'LastName': 'Douoguih', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiebaut', 'Affiliation': 'University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France. Electronic address: rodolphe.thiebaut@u-bordeaux.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30476-X']
2775,33217374,Treating Heel Pain in Adults: A Randomized Clinical Trial of Hard Versus Modified Soft Custom Orthotics and Heel Pads.,"OBJECTIVES


This study compared the effectiveness of soft versus hard orthotics in treating heel pain and plantar fasciitis in adults. It also compared the level of function after orthotic use, cost and number of visits for orthotics and explored if age was a factor in orthotic effectiveness.
DESIGN


This is a randomized clinical trial. Prior to randomization, patients were stratified by age (younger versus older adults), in blocks of four to ensure that there are an equal number of participants in each group (soft versus hard orthotics).
SETTING


The settings that participants were recruited from were 1) an orthotic clinic in a community-based hospital and 2) a private orthotic clinic.
PARTICIPANTS


The participants were adults (18+) with heel pain and plantar fasciitis.
INTERVENTION


Participants received hard or soft customized orthotics.
MAIN OUTCOME MEASURES


Participants rated their pain intensity and pain interference pre and post orthotic use using subscales from the Brief Pain Inventory. Function was similarly measured using the Late Life Function and Disability Instrument: Function component. Analyses of age, cost and number of visits were also compared.
RESULTS


There was a reduction in pain intensity (P=0.010) and pain interference (P<0.001) but no change in function over time (P=0.333), and no difference between the groups who received hard versus soft orthotics. Age had no effect on orthotic effectiveness. Soft orthotics were less expensive (P<0.0001) and required fewer visits for fabrication (P<0.0001).
CONCLUSION


Both soft and hard orthotics provided effective pain relief, however, soft orthotics are less expensive.",2020,"There was a reduction in pain intensity (P=0.010) and pain interference (P<0.001) but no change in function over time (P=0.333), and no difference between the groups who received hard versus soft orthotics.","['heel pain and plantar fasciitis in adults', 'patients were stratified by age (younger versus older adults', 'participants were adults (18+) with heel pain and plantar fasciitis', 'Adults', 'The settings that participants were recruited from were 1) an orthotic clinic in a community-based hospital and 2) a private orthotic clinic']","['Hard Versus Modified Soft Custom Orthotics and Heel Pads', 'soft versus hard orthotics', 'Participants received hard or soft customized orthotics']","['pain interference', 'pain intensity', 'orthotic effectiveness', 'pain intensity and pain interference pre', 'effective pain relief']","[{'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}]","[{'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332568', 'cui_str': 'Pad'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.197917,"There was a reduction in pain intensity (P=0.010) and pain interference (P<0.001) but no change in function over time (P=0.333), and no difference between the groups who received hard versus soft orthotics.","[{'ForeName': 'Deborah A R', 'Initials': 'DAR', 'LastName': 'Seligman', 'Affiliation': 'Department of Occupational Therapy, Baycrest, 3560 Bathurst Street, Toronto, Ontario, Canada, M6A 2E1; Department of Rehabilitation Science, University of Toronto, 500 University Avenue, Toronto, ON, Canada, M5G 1V7; Orthotics Clinic, 1017 Wilson Avenue, Suite 304, Toronto, Ontario, Canada M3K 1Z1. Electronic address: debbieseligman@hotmail.com.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Dawson', 'Affiliation': 'Professor & Interim Chair, Department of Occupational Science & Occupational Therapy; Member, Rehabilitation Sciences Institute, University of Toronto; Senior Scientist, Rotman Research Institute, Baycrest, Suite 160-500 University Avenue, Rehabilitation Sciences Building, University of Toronto, Toronto, Ontario, Canada M5G 1V7.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': ""Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada; Department of Psychiatry, University of Toronto; Canadian Psychological Association, American Psychological Association, Society for Personality Assessment, St. Joseph's Healthcare, West 5th Campus, 100 West 5(th) Street, Box 585, Room B386, Hamilton, ON, Canada L8N 3K7.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Seligman', 'Affiliation': ""Faculty of Medicine, Royal College of Surgeons in Ireland, 123 St. Stephen's Green, Dublin, Ireland.""}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Davis', 'Affiliation': 'Krembil Research Institute, University Health Network, MP11-322, 399 Bathurst Street, Toronto, Ontario, M5T 2S8; Departments of Physical Therapy and Surgery, Rehabilitation Science Institute, Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, and Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.10.124']
2776,33217805,Comparison of kinesio taping and sham taping in patients with chronic low back pain: A protocol of randomized controlled trial.,"BACKGROUND


Chronic low back pain (CLBP) is a clinical condition characterized by moderate to severe pain in the lower spine that severely affects the patient's life experience and leads to disability and absenteeism. In the past few years, kinesio tape (KT) have been utilized by physiotherapists as a relatively novel band-aid method to reduce the pain of musculoskeletal disorders. Therefore, in this particular study, we intended to search the effects of KT and sham KT on pain, lumbar range of motion, and disability for CLBP.
METHODS


The present study was experimented in a physiotherapy clinic in the Yancheng First People's Hospital of Jiangsu Province. The study design was a randomized, double-blinded clinical trial. Inclusion criteria for the study were the followings: chief complaint pain in the area between 12 ribs and hip creases with or without leg pain; ages ranges from 18 to 65; low back pain lasts <6 weeks; and at any rate medium pain intensity (pain score ≥4). Participants were randomly allocated to 1 of 2 parallel combinations to receive either therapeutic KT or sham KT. Patients were assessed at baseline, at the end of the 12-day intervention, and at 4 weeks of follow-up. The main result measure was pain intensity using a numerical rating scale (NRS), and the secondary outcome measure was lumbar lateral flexion activity, Oswestry Disability Index (ODI), and adverse effects including allergic reactions or skin problems.
CONCLUSIONS


The results of this study will provide new information about the usefulness of KT as an additional component of a guideline-endorsed physiotherapy program in patients with chronic nonspecific low back pain.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry6070).",2020,"The results of this study will provide new information about the usefulness of KT as an additional component of a guideline-endorsed physiotherapy program in patients with chronic nonspecific low back pain.
","['patients with chronic nonspecific low back pain', 'patients with chronic low back pain', 'Inclusion criteria for the study were the followings: chief complaint pain in the area between 12 ribs and hip creases with or without leg pain; ages ranges from 18 to 65; low back pain lasts <6 weeks; and at any rate medium pain intensity (pain score ≥4', ""The present study was experimented in a physiotherapy clinic in the Yancheng First People's Hospital of Jiangsu Province"", 'Chronic low back pain (CLBP']","['KT and sham KT', 'kinesio tape (KT', 'kinesio taping and sham taping', 'therapeutic KT or sham KT']","['pain intensity using a numerical rating scale (NRS', 'lumbar lateral flexion activity, Oswestry Disability Index (ODI), and adverse effects including allergic reactions or skin problems', 'pain, lumbar range of motion, and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035561', 'cui_str': 'Bone structure of rib'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0281822', 'cui_str': 'Skin problem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.324171,"The results of this study will provide new information about the usefulness of KT as an additional component of a guideline-endorsed physiotherapy program in patients with chronic nonspecific low back pain.
","[{'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Spine Surgery, Yancheng First People's Hospital of Jiangsu Province.""}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Spine Surgery, Yancheng First People's Hospital of Jiangsu Province.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': ""Department of Spine Surgery, Yancheng First People's Hospital of Jiangsu Province.""}, {'ForeName': 'Yongming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, Second Affiliated Hospital of Suzhou University, China.'}]",Medicine,['10.1097/MD.0000000000023042']
2777,33217814,Effect of home-based high-intensity interval training using telerehabilitation among coronary heart disease patients.,"INTRODUCTION


Cardiovascular diseases are the world's most common causes of morbidity and mortality in the population, including Central Europe. Cardiac rehabilitation (CR) is an effective preventive approach that includes several core components. Physical training is identified as an integral and essential part of CR. Training can positively influence several cardiovascular risk factors in people diagnosed with coronary heart disease and prevent them from clinical events. Our study aims to research the method of high-intensity interval training (HIIT) in a home environment using telerehabilitation. We assume that the HIIT form of telerehabilitation, using a heart rate monitor as a tool for backing up training data, can improve cardiorespiratory fitness and lead to higher peak oxygen uptake than the traditional moderate-intensity continuous training (MICT).
METHODS


This study is designed as a monocentral randomized controlled trial at University Hospital Brno in the Czech Republic. After the coronary heart event, the suitable patients will be randomized (1:1 ratio) and separated into 2 groups: the experimental HIIT group and the control MICT group. Both groups undergo a 12-week telerehabilitation with a 1-year follow-up period. Study participants will be telemonitored during physical training in their home environment via a heart rate monitor and a web platform. Once a week, the patients will give their feedback and motivation by a telephone call.The primary outcome observed will be the effect of intervention expressed by changes in cardiorespiratory fitness. Secondary outcomes will be the health-related quality of life, anxiety, training adherence, body composition, safety, and satisfaction.
DISCUSSION


The HIIT is widely researched predominantly in a center-based supervised form. Our study differs from others by the use of telemedicine and smart technologies in home-based settings. Previous home-based cardiac telerehabilitation studies have focused primarily on MICT, which has demonstrated feasibility, and results have shown similar improvements as center-based CR. There is a presumption that HIIT may be superior to MICT. However, it can be complicated to self-dose the method in the home environment. Investigators expect that HIIT research will provide insight into the possibilities of telemedicine feasibility, effect, and limitations of coronary heart disease patients' use at low to moderate cardiovascular risk.",2020,"Secondary outcomes will be the health-related quality of life, anxiety, training adherence, body composition, safety, and satisfaction.
","['University Hospital Brno in the Czech Republic', 'people diagnosed with coronary heart disease', 'coronary heart disease patients', 'Study participants will be telemonitored during physical training in their home environment via a heart rate monitor and a web platform']","['home-based high-intensity interval training', 'control MICT', 'high-intensity interval training (HIIT', 'Cardiac rehabilitation (CR', 'Physical training']","['cardiorespiratory fitness', 'health-related quality of life, anxiety, training adherence, body composition, safety, and satisfaction']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0473706,"Secondary outcomes will be the health-related quality of life, anxiety, training adherence, body composition, safety, and satisfaction.
","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Dosbaba', 'Affiliation': 'Department of Rehabilitation, University Hospital Brno.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hartman', 'Affiliation': 'Department of Rehabilitation, University Hospital Brno.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Hnatiak', 'Affiliation': 'Department of Rehabilitation, University Hospital Brno.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Batalik', 'Affiliation': 'Department of Rehabilitation, University Hospital Brno.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Ludka', 'Affiliation': 'Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}]",Medicine,['10.1097/MD.0000000000023126']
2778,33217822,Efficacy of belt electrode skeletal muscle electrical stimulation on muscle flexibility of lower limbs: A randomized controlled pilot trial.,"BACKGROUND


Muscular contracture may be caused by immobility-induced muscle atrophy and skeletal muscle hypoxia. Belt electrode skeletal muscle electrical stimulation (B-SES) is a new type of neuromuscular electrical stimulation that can simultaneously contract the lower limb muscle groups, in contrast to the conventional pad-type electrodes. B-SES can suppress muscular atrophy and relieve hypoxia of the skeletal muscle and is considered an appropriate strategy for preventing muscular contracture. However, the effect of B-SES on muscle flexibility has not been verified. This study aimed to compare the immediate effects of B-SES on skeletal muscle flexibility using different stimulation modes before the clinical study.
METHODS


We conducted a randomized controlled pilot trial with cross-over analysis of 10 healthy subjects. The participants were subjected to three stimulus conditions (Disuse B-SES, Metabolic B-SES, and Control) with a minimal interval of 1 day between interventions, and the lower limb flexibility before and after the B-SES intervention was evaluated. Lower extremity flexibility was evaluated based on the hamstring muscle stiffness and sit-and-reach distance. For each endpoint, within-group comparisons were performed before and after the intervention and were compared between the groups using paired t-tests. Changes in each endpoint before and after the intervention were analyzed using repeated-measures analysis of variance and the Bonferroni method. The significance level was 0.05.
RESULTS


Ten healthy individuals participated in all three interventions with a washout period between each intervention. In the Metabolic B-SES group, the sit-and-reach distance after the intervention was significantly higher than that before the intervention (P < 0.05). A comparison of the change in the sit-and-reach distance among the three groups before subsequent tests showed that the Metabolic B-SES group had a significantly increased sit-and-reach distance compared with the control group (P < 0.05).
CONCLUSION


Metabolic B-SES was effective for the immediate improvement of flexibility of the lower limb muscles. Therefore, Metabolic B-SES may be useful as a strategy for preventing muscular contracture.",2020,"A comparison of the change in the sit-and-reach distance among the three groups before subsequent tests showed that the Metabolic B-SES group had a significantly increased sit-and-reach distance compared with the control group (P < 0.05).
","['10 healthy subjects', 'lower limbs', 'Ten healthy individuals']","['Belt electrode skeletal muscle electrical stimulation (B-SES', 'B-SES', 'belt electrode skeletal muscle electrical stimulation']","['skeletal muscle flexibility', 'sit-and-reach distance', 'Lower extremity flexibility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",10.0,0.0230178,"A comparison of the change in the sit-and-reach distance among the three groups before subsequent tests showed that the Metabolic B-SES group had a significantly increased sit-and-reach distance compared with the control group (P < 0.05).
","[{'ForeName': 'Kouki', 'Initials': 'K', 'LastName': 'Tomida', 'Affiliation': 'Department of Physical Therapy, Akita Rehabilitation College, 1-4-80, Barajima.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Nakae', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Graduate School of Medicine, Akita University 1-1-1 Hondo Akita, Japan.'}]",Medicine,['10.1097/MD.0000000000023156']
2779,33217826,Effects of progressive muscle relaxation training on negative emotions and sleep quality in COVID-19 patients: A clinical observational study.,"This study investigates the effect of progressive muscle relaxation training on negative mood and sleep quality in Coronavirus Pneumonia (COVID-19) patients.COVID-19 is an emerging infectious disease, and there is still uncertainty about when the outbreak will be contained and the effectiveness of treatments. Considering that this disease is highly contagious, patients need to be treated in isolation. This may lead to psychological symptoms such as anxiety and depression, and even sleep problems.This study is a clinical observation study.Participants included 79 COVID-19 patients admitted to a designated hospital for COVID-19 patients in Wuhan from February to March, 2020. Patients were selected and assigned to the control group and the observation group according to their wishes, with 40 and 39 cases in each group, respectively. The control group received routine treatment and nursing, and the observation group received progressive muscle relaxation training, in addition to the routine treatment and nursing. We compared scores of the Pittsburgh Sleep Quality Index Scale (PSQI), the Generalized Anxiety Disorder (GAD-7), and the Patient Health Questionnaire (PHQ-9) before and after the intervention.There was no significant difference in PSQI, GAD-7, and PHQ-9 scores between the control group and the observation group before the intervention (P > .05). After the intervention, the difference in scores of PSQI, GAD-7, and PHQ-9 in the 2 groups were statistically significant (P < .05).Progressive muscle relaxation training can significantly reduce anxiety and depression and improve sleep quality in COVID-19 patients during isolation treatment.Progressive muscle relaxation training was shown to improve the treatment effect of patients and is worthy of clinical promotion.",2020,"There was no significant difference in PSQI, GAD-7, and PHQ-9 scores between the control group and the observation group before the intervention (P > .05).","['COVID-19 patients', 'Participants included 79 COVID-19 patients admitted to a designated hospital for COVID-19 patients in Wuhan from February to March, 2020', 'Coronavirus Pneumonia (COVID-19) patients']","['progressive muscle relaxation training', 'Progressive muscle relaxation training', 'routine treatment and nursing, and the observation group received progressive muscle relaxation training']","['negative mood and sleep quality', 'Pittsburgh Sleep Quality Index Scale (PSQI), the Generalized Anxiety Disorder (GAD-7), and the Patient Health Questionnaire (PHQ-9', 'scores of PSQI, GAD-7, and PHQ-9', 'negative emotions and sleep quality', 'anxiety and depression and improve sleep quality', 'PSQI, GAD-7, and PHQ-9 scores']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",79.0,0.0155146,"There was no significant difference in PSQI, GAD-7, and PHQ-9 scores between the control group and the observation group before the intervention (P > .05).","[{'ForeName': 'Chun-Xiu', 'Initials': 'CX', 'LastName': 'Xiao', 'Affiliation': 'Nursing Department.'}, {'ForeName': 'Yan-Juan', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Nursing Department.'}, {'ForeName': 'Ren-Qin', 'Initials': 'RQ', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'An-Na', 'Initials': 'AN', 'LastName': 'Liu', 'Affiliation': 'Department of Burns.'}, {'ForeName': 'Gui-Qin', 'Initials': 'GQ', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Cai-Feng', 'Initials': 'CF', 'LastName': 'Lan', 'Affiliation': 'Department of Obstetrics and Gynecology of Fujian Medical University Union Hospital, Fuzhou City, Fujian Province, China.'}]",Medicine,['10.1097/MD.0000000000023185']
2780,33217827,Topical clotrimazole cream for the treatment of tinea cruris: A retrospective study.,"This retrospective study assessed the efficacy and safety of 1% topical clotrimazole cream for the treatment of patients with tinea cruris (TC).We included 86 patients with confirmed TC for the presence of fungal hyphae. Of those, 43 patients received 1% topical clotrimazole cream for a total of 4 consecutive weeks, and were assigned to an experimental group. The other 43 patients underwent 1% topical butenafine cream for a total of 2 consecutive weeks, and were allocated to a control group. The efficacy and safety were measured and analyzed after 4 weeks treatment.After treatment, patients in both groups achieved better improvements in erythema (P < .01), scaling (P < .01), itching (P < .01), and KOH-negative results (P < .01), compared with those in patients before the treatment. However, there were not significant differences in erythema (P = .61), scaling (P = .57), itching (P = .47), and KOH-negative results (P = .67) between 2 groups. In addition, no treatment-related adverse events were recorded in both groups.Both 1% topical clotrimazole and butenafine cream are found to be effective and safe for patients with TC. However, there is not significant difference in efficacy and safety between two groups.",2020,"After treatment, patients in both groups achieved better improvements in erythema (P < .01), scaling (P < .01), itching (P < .01), and KOH-negative results (P < .01), compared with those in patients before the treatment.","['43 patients underwent 1', 'patients with TC', 'patients with tinea cruris (TC).We included 86 patients with confirmed TC for the presence of fungal hyphae', '43 patients received', 'tinea cruris']","['topical clotrimazole cream', 'Topical clotrimazole cream', '1% topical clotrimazole cream', 'clotrimazole and butenafine cream', 'topical butenafine cream']","['erythema', 'itching', 'efficacy and safety', 'adverse events', 'effective and safe', 'KOH-negative results']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040253', 'cui_str': 'Tinea of perianal region'}, {'cui': 'C0040247', 'cui_str': 'Tinea infection'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0521057', 'cui_str': 'Hypha'}]","[{'cui': 'C3208397', 'cui_str': 'Clotrimazole-containing product in cutaneous dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0107497', 'cui_str': 'butenafine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}]",86.0,0.0138256,"After treatment, patients in both groups achieved better improvements in erythema (P < .01), scaling (P < .01), itching (P < .01), and KOH-negative results (P < .01), compared with those in patients before the treatment.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Dermatology.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology.'}, {'ForeName': 'Ying-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': 'Department of Geriatrics, The Second Affiliated Hospital of Mudanjiang Medical University, Mudanjiang, China.'}, {'ForeName': 'Chuan-Hua', 'Initials': 'CH', 'LastName': 'Jiao', 'Affiliation': 'Department of Dermatology.'}]",Medicine,['10.1097/MD.0000000000023189']
2781,33217829,Differences in midazolam premedication effects on recovery after short-duration ambulatory anesthesia with propofol or sevoflurane for gynecologic surgery in young patients: A randomized controlled trial.,"BACKGROUND


Anxiolytic premedication requires careful consideration owing to potential side effects including delayed recovery after ambulatory anesthesia. We aimed to compare the effect of midazolam on recovery profiles postoperatively, depending on whether propofol or sevoflurane was the primary anesthetic.
METHODS


We enrolled 226 patients (age, 18-50 years) undergoing ambulatory gynecologic laparoscopic surgery. Patients were categorized into propofol without midazolam (P), propofol with midazolam (MP), sevoflurane without midazolam (S), and sevoflurane with midazolam (MS) groups. As premedication, placebo or 0.02 mg/kg intravenous midazolam was used. The primary outcome was the difference in the time from anesthetic discontinuation to eye opening in response to verbal command. Secondary outcomes included postoperative nausea and pain occurrence and time to reach the discharge score.
RESULTS


The time from anesthetic discontinuation to eye opening was longer in the MP group (n = 49) than in the P group (n = 50; P < .001) but was not significantly different between the MS (n = 50) and S groups (n = 49; P = .1). Midazolam premedication did not significantly affect postoperative nausea in the MP group compared with that in the P group (P = .3) but had a nausea prevention effect in the MS group compared with that in the S group (P < .001). The time to reach the discharge score was similar in all patients regardless of midazolam administration.
CONCLUSION


In the recovery from short-duration ambulatory gynecologic surgery in young patients, intravenous midazolam premedication showed positive effects on postoperative nausea without affecting the time from anesthetic discontinuation to eye opening with sevoflurane-based anesthesia but prolonged the time from anesthetic discontinuation to eye opening with propofol-based anesthesia. Because this difference between the propofol groups is not clinically significant, the results support midazolam premedication in young women. Further studies assessing larger populations are needed.",2020,Midazolam premedication did not significantly affect postoperative nausea in the MP group compared with that in the P group (,"['young women', '226 patients (age, 18-50 years) undergoing', 'young patients']","['ambulatory gynecologic laparoscopic surgery', 'placebo', 'midazolam', 'sevoflurane-based anesthesia', 'Midazolam', 'propofol or sevoflurane', 'propofol', 'propofol without midazolam (P), propofol with midazolam (MP), sevoflurane without midazolam (S), and sevoflurane with midazolam (MS']","['postoperative nausea and pain occurrence and time to reach the discharge score', 'postoperative nausea', 'time from anesthetic discontinuation to eye opening in response to verbal command', 'nausea prevention effect', 'time from anesthetic discontinuation to eye opening', 'time to reach the discharge score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",226.0,0.293973,Midazolam premedication did not significantly affect postoperative nausea in the MP group compared with that in the P group (,"[{'ForeName': 'Hyunjee', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sung-Sik', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023194']
2782,33217833,Comparison of the intraoperative analgesic efficacy between ultrasound-guided deep and superficial serratus anterior plane block during video-assisted thoracoscopic lobectomy: A prospective randomized clinical trial.,"BACKGROUND


The serratus anterior plane block (SAPB) is a novel method that provides lateral chest wall analgesia. There are 2 methods of SAPB; deep and superficial SAPB. Each of these methods has been demonstrated to provide effective perioperative analgesia in thoracic surgery. The aim of this study was to compare the intraoperative hemodynamic and analgesic benefits of deep versus superficial SAPB during video-assisted thoracic surgery (VATS) lobectomy.
METHODS


We performed a prospective, randomized, patient/assessor-blinded trial. We included patients who were 20 to 75 years of age and scheduled to undergo VATS lobectomy with American Society of Anesthesiologists physical status 1 or 2. Patients were randomly allocated to receive either ultrasound-guided deep SAPB (Group D) or superficial SAPB (Group S). The primary outcome was intraoperative remifentanil consumption. We also recorded intraoperative systolic blood pressure (SBP), heart rate (HR), emergence time, and doses of rescue drugs used to manage hemodynamic instability.
RESULTS


Data for 50 patients undergoing 3-port VATS lobectomy were analyzed. Intraoperative remifentanil consumption did not differ significantly between Group D (n = 25, 715.62 ± 320.36 μg) and group S (n = 25, 721.08 ± 294.48 μg) (P = .97). Additionally, there were no significant differences between the 2 groups in SBP and HR at any time point, emergence time, or amount of rescue drugs used.
CONCLUSION


Our study suggests that the intraoperative analgesic efficacy is similar for deep and superficial SAPB during VATS lobectomy.",2020,"Intraoperative remifentanil consumption did not differ significantly between Group D (n = 25, 715.62 ± 320.36 μg) and group S (","['50 patients undergoing 3-port VATS lobectomy', 'patients who were 20 to 75 years of age and scheduled to undergo VATS lobectomy with American Society of Anesthesiologists physical status 1 or 2', 'n\u200a=\u200a25, 721.08\u200a±\u200a294.48\u200aμg']","['ultrasound-guided deep SAPB (Group D) or superficial SAPB', 'deep versus superficial SAPB during video-assisted thoracic surgery (VATS) lobectomy', 'ultrasound-guided deep and superficial serratus anterior plane block during video-assisted thoracoscopic lobectomy']","['intraoperative remifentanil consumption', 'intraoperative systolic blood pressure (SBP), heart rate (HR), emergence time, and doses of rescue drugs used to manage hemodynamic instability', 'Intraoperative remifentanil consumption', 'SBP and HR at any time point, emergence time, or amount of rescue drugs used']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]",50.0,0.153461,"Intraoperative remifentanil consumption did not differ significantly between Group D (n = 25, 715.62 ± 320.36 μg) and group S (","[{'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Kyungpook National University.'}, {'ForeName': 'Jungwon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine.'}, {'ForeName': 'Hyuckgoo', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine.'}, {'ForeName': 'Jeongeun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine.'}, {'ForeName': 'Jiseob', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Saeyoung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Kyungpook National University.'}]",Medicine,['10.1097/MD.0000000000023214']
2783,31834056,Orphenadrine in treatment of muscle cramps in cirrhotic patients: a randomized study.,"OBJECTIVE


Many patients of liver cirrhosis are complaining of muscle cramps, which are annoying to them. There is no effective treatment for muscle cramps in cirrhotic patients till now. This study purposed to evaluate efficacy and safety of orphenadrine in the treatment of muscle cramps in cirrhotic patients.
METHODS


One hundred and twenty four patients who had muscle cramps three or more times weekly were included. They were divided into two arms: 62 patients administrated orphenadrine and 62 administrated placebo. They were followed up till 2 weeks after the end of therapy. Muscle cramps were evaluated using questionnaire as regards severity, duration, and frequency. Also, side effects of orphenadrine were recorded.
RESULTS


Frequency, duration of muscle cramps, and pain score improved significantly after 1 month of orphenadrine therapy in comparison to placebo. Few side effects were recorded in the form of dry mouth, drowsiness, and nausea.
CONCLUSION


Orphenadrine is considered as promising safe drug for treatment of muscle cramps associated with liver cirrhosis.",2020,"RESULTS


Frequency, duration of muscle cramps, and pain score improved significantly after 1 month of orphenadrine therapy in comparison to placebo.","['cirrhotic patients', 'One hundred and twenty four patients who had muscle cramps three or more times weekly were included']","['orphenadrine', 'orphenadrine and 62 administrated placebo', 'Orphenadrine', 'placebo']","['Muscle cramps', 'drowsiness, and nausea', 'efficacy and safety', 'muscle cramps', 'Frequency, duration of muscle cramps, and pain score']","[{'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0029309', 'cui_str': 'Orphenadrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",124.0,0.0515254,"RESULTS


Frequency, duration of muscle cramps, and pain score improved significantly after 1 month of orphenadrine therapy in comparison to placebo.","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'aDepartment of Tropical medicine, Faculty of Medicine, Tanta University bDepartment of Public health, Menofia University, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Ebrahim', 'Affiliation': ''}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': ''}, {'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'Alkhalawany', 'Affiliation': ''}, {'ForeName': 'Asem', 'Initials': 'A', 'LastName': 'Elfert', 'Affiliation': ''}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Hawash', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Elkadeem', 'Affiliation': ''}, {'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Badawi', 'Affiliation': ''}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001622']
2784,33220216,"Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine versus single screening and treatment for the control of malaria in pregnancy in Papua, Indonesia: a provider perspective analysis from a cluster-randomised trial.","BACKGROUND


Malaria infection during pregnancy is associated with serious adverse maternal and birth outcomes. A randomised controlled trial in Papua, Indonesia, comparing the efficacy of intermittent preventive treatment with dihydroartemisinin-piperaquine with the current strategy of single screening and treatment showed that intermittent preventive treatment is a promising alternative treatment for the reduction of malaria in pregnancy. We aimed to estimate the incremental cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine compared with single screening and treatment with dihydroartemisinin-piperaquine.
METHODS


We did a provider perspective analysis. A decision tree model was analysed from a health provider perspective over a lifetime horizon. Model parameters were used in deterministic and probabilistic sensitivity analyses. Simulations were run in hypothetical cohorts of 1000 women who received intermittent preventive treatment or single screening and treatment. Disability-adjusted life-years (DALYs) for fetal loss or neonatal death, low birthweight, moderate or severe maternal anaemia, and clinical malaria were calculated from trial data and cost estimates in 2016 US dollars from observational studies, health facility costings and public procurement databases. The main outcome measure was the incremental cost per DALY averted.
FINDINGS


Relative to single screening and treatment, intermittent preventive treatment resulted in an incremental cost of US$5657 (95% CI 1827 to 9448) and 107·4 incremental DALYs averted (-719·7 to 904·1) per 1000 women; the average incremental cost-effectiveness ratio was $53 per DALY averted.
INTERPRETATION


Intermittent preventive treatment with dihydroartemisinin-piperaquine offers a cost-effective alternative to single screening and treatment for the prevention of the adverse effects of malaria infection in pregnancy in the context of the moderate malaria transmission setting of Papua. The higher cost of intermittent preventive treatment was driven by monthly administration, as compared with single-administration single screening and treatment. However, acceptability and feasibility considerations will also be needed to inform decision making.
FUNDING


Medical Research Council, Department for International Development, and Wellcome Trust.",2020,"The higher cost of intermittent preventive treatment was driven by monthly administration, as compared with single-administration single screening and treatment.","['1000 women who received', 'malaria in pregnancy in Papua, Indonesia']","['single screening and treatment with dihydroartemisinin-piperaquine', 'intermittent preventive treatment or single screening and treatment', 'dihydroartemisinin-piperaquine versus single screening and treatment', 'dihydroartemisinin-piperaquine']","['Cost-effectiveness', 'incremental cost per DALY averted', 'Disability-adjusted life-years (DALYs) for fetal loss or neonatal death, low birthweight, moderate or severe maternal anaemia, and clinical malaria', 'average incremental cost-effectiveness ratio']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.161322,"The higher cost of intermittent preventive treatment was driven by monthly administration, as compared with single-administration single screening and treatment.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Paintain', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: lucy.paintain@lshtm.ac.uk.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Ahmed', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Umbu Reku Landuwulang', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Ansariadi', 'Initials': 'A', 'LastName': 'Ansariadi', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia; Department of Epidemiology, School of Public Health, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Rini Poespoprodjo', 'Affiliation': 'Mimika District Health Authority, Timika, Papua, Indonesia; Timika Malaria Research Program, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Pediatric Research Office, Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Khairallah', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Faustina Helena', 'Initials': 'FH', 'LastName': 'Burdam', 'Affiliation': 'Mimika District Health Authority, Timika, Papua, Indonesia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bonsapia', 'Affiliation': 'Timika Malaria Research Program, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30386-7']
2785,33220217,Effect of a mobile phone intervention for female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT): a cluster-randomised controlled trial.,"BACKGROUND


Female sex workers in low-income and middle-income countries face high risks of unintended pregnancy. We developed a 12-month, multifaceted short messaging service intervention (WHISPER) for female sex workers in Kenya who had the potential to become pregnant, to improve their contraceptive knowledge and behaviours. The aim of this study was to assess the effectiveness of the intervention to reduce the incidence of unintended pregnancy among sex workers in Kenya compared with an equal-attention control group receiving nutrition-focused messages (SHOUT).
METHODS


Our two-arm, cluster-randomised controlled trial was done in sex-work venues in two subcounties of Mombasa, Kenya (Kisauni and Changamwe). Participants, aged 16-34 years, not pregnant or planning pregnancy, able to read text messages in English, residing in the study area, and who had a personal mobile phone with one of two phone networks, were recruited from 93 randomly selected sex-work venues (clusters). Random cluster allocation (1:1) to the intervention or control group was concealed from participants and researchers until the intervention started. Both groups received text messages in English delivered two to three times per week for 12 months (137 messages in total), as well as additional on-demand messages. Message content in the intervention group focused on promotion of contraception, particularly long-acting reversible contraception and dual method contraceptive use; message content in the control group focused on promotion of nutritional knowledge and practices, including food safety, preparation, and purchasing. The primary endpoint, analysed in all participants who were randomly assigned and attended at least one follow-up visit, compared unintended pregnancy incidence between groups using discrete-time survival analysis at 6 and 12 months. This trial is registered with Australian New Zealand Clinical Trials Registry, ACTRN12616000852459, and is closed to new participants.
FINDINGS


Between Sept 14, 2016, and May 16, 2017, 1728 individuals were approached to take part in the study. Of these, 1155 were eligible for full screening, 1035 were screened, and 882 were eligible, enrolled, and randomly assigned (451 participants from 47 venues in the intervention group; 431 participants from 46 venues in the control group). 401 participants from the intervention group and 385 participants from the control group were included in the primary analysis. Incidence of unintended pregnancy was 15·5 per 100 person-years in the intervention group and 14·7 per 100 person-years in the control group (hazard ratio 0·98, 95% CI 0·69-1·39).
INTERPRETATION


The intervention had no measurable effect on unintended pregnancy incidence. Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation.
FUNDING


National Health and Medical Research Council of Australia.",2020,"Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation.
","['1155 were eligible for full screening, 1035 were screened, and 882 were eligible, enrolled, and randomly assigned (451 participants from 47 venues in the intervention group; 431 participants from 46 venues in the control group', 'Our two-arm, cluster-randomised controlled trial was done in sex-work venues in two subcounties of Mombasa, Kenya (Kisauni and Changamwe', 'Female sex workers in low-income and middle-income countries', 'Participants, aged 16-34 years, not pregnant or planning pregnancy, able to read text messages in English, residing in the study area, and who had a personal mobile phone with one of two phone networks, were recruited from 93 randomly selected sex-work venues (clusters', 'female sex workers in Kenya who had the potential to become pregnant, to improve their contraceptive knowledge and behaviours', 'female sex workers', '1728 individuals were approached to take part in the study', '401 participants from the intervention group and 385 participants from the control group were included in the primary analysis', 'sex workers in Kenya compared with an', 'female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT']","['equal-attention control group receiving nutrition-focused messages (SHOUT', 'multifaceted short messaging service intervention (WHISPER', 'mobile phone intervention']","['Incidence of unintended pregnancy', 'unintended pregnancy incidence']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0032992', 'cui_str': 'Pregnant - planned'}, {'cui': 'C0586740', 'cui_str': 'Able to read'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0240816', 'cui_str': 'Sex worker'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0234766', 'cui_str': 'Whispering'}, {'cui': 'C0562551', 'cui_str': 'Shouting'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0562551', 'cui_str': 'Shouting'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234766', 'cui_str': 'Whispering'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}]",1728.0,0.17885,"Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation.
","[{'ForeName': 'Frances H', 'Initials': 'FH', 'LastName': 'Ampt', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Megan S C', 'Initials': 'MSC', 'LastName': 'Lim', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Agius', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': ""L'Engle"", 'Affiliation': 'Department of Health Professions, University of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Griffins', 'Initials': 'G', 'LastName': 'Manguro', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gichuki', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gichangi', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya; Technical University of Mombasa, Mombasa, Kenya; Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': 'Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Jaoko', 'Affiliation': 'Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Temmerman', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya; Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium; Department of Obstetrics and Gynecology, Aga Khan University, Nairobi, Kenya.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stoové', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia; School of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hellard', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Infectious Diseases, The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium; Department of Population Health, Aga Khan University, Nairobi, Kenya. Electronic address: stanley.luchters@aku.edu.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30389-2']
2786,33220252,The Colombian chemoprevention trial. Twenty-year follow-up of a cohort of patients with gastric precancerous lesions.,"BACKGROUND AND AIMS


Helicobacter pylori eradication and endoscopic surveillance of gastric precancerous lesions are strategies to reduce gastric cancer (GC) risk. This study is the longest prospective cohort of an H. pylori eradication trial in a Hispanic population.
METHODS


800 adults with precancerous lesions were randomized to anti-H. pylori treatment or placebo. Gastric biopsies at baseline, 3, 6, 12, 16, and 20 years were assessed by our Correa histopathology score. A generalized linear mixed model with a subject level random intercept was used to estimate the effect of H. pylori status on the score over time. Logistic regression models were used to estimate progression by baseline diagnosis, and GC risk by intestinal metaplasia (IM) subtype and anatomic location.
RESULTS


356 individuals completed 20 years of follow-up. Anti-H. pylori therapy (intention-to-treat) reduced progression of the Correa score (odds ratio OR, 0.59, 95% confidence interval, CI, 0.38-0.93). H. pylori-negative status had a beneficial effect on the score over time (P=0.036). Among individuals with IM (including indefinite for dysplasia) at baseline, incidence rates per 100 person-years were 1.09 (95% CI, 0.85-1.33) for low-grade/high-grade dysplasia and 0.14 (95% CI, 0.06-0.22) for GC. Incomplete-type (vs. complete-type) IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8). Individuals with corpus (vs. antrum-restricted) IM showed an OR of 2.1 (95% CI, 0.7-6.6) for GC.
CONCLUSIONS


In a high GC risk Hispanic population, anti-H. pylori therapy had a long-term beneficial effect against histological progression. Incomplete IM is a strong predictor of GC risk.",2020,"IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8).","['800 adults with precancerous lesions', 'Hispanic population', 'Individuals with corpus (vs. antrum-restricted', 'patients with gastric precancerous lesions', '356 individuals completed 20 years of follow-up']",['anti-H. pylori treatment or placebo'],"['GC risk by intestinal metaplasia (IM) subtype and anatomic location', 'progression of the Correa score (odds ratio', 'GC risk']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034193', 'cui_str': 'Pyloric antrum structure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0334037', 'cui_str': 'Intestinal metaplasia'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",800.0,0.177121,"IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8).","[{'ForeName': 'M Blanca', 'Initials': 'MB', 'LastName': 'Piazuelo', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: maria.b.piazuelo@vumc.org.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Bravo', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Robertino M', 'Initials': 'RM', 'LastName': 'Mera', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'M Constanza', 'Initials': 'MC', 'LastName': 'Camargo', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Bravo', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Alberto G', 'Initials': 'AG', 'LastName': 'Delgado', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'M Kay', 'Initials': 'MK', 'LastName': 'Washington', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Rosero', 'Affiliation': 'Universidad de Nariño, Pasto, Nariño, Colombia.'}, {'ForeName': 'Luz S', 'Initials': 'LS', 'LastName': 'Garcia', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Realpe', 'Affiliation': 'Fundación Hospital San Pedro, Pasto, Nariño, Colombia.'}, {'ForeName': 'Sandra P', 'Initials': 'SP', 'LastName': 'Cifuentes', 'Affiliation': 'Fundación Hospital San Pedro, Pasto, Nariño, Colombia.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Morgan', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Gastroenterology, Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Peek', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Pelayo', 'Initials': 'P', 'LastName': 'Correa', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Wilson', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA; Veterans Affairs Tennessee Valley Healthcare System, Nashville, TN, USA.'}]",Gastroenterology,['10.1053/j.gastro.2020.11.017']
2787,33220297,Endorectal formalin instillation or argon plasma coagulation for hemorrhagic radiation proctopathy therapy: a prospective and randomized clinical trial.,,2020,,[],['Endorectal formalin instillation or argon plasma coagulation'],[],[],"[{'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C1879736', 'cui_str': 'Argon plasma coagulation'}]",[],,0.0430224,,"[{'ForeName': 'Flávia Siqueira', 'Initials': 'FS', 'LastName': 'Furtado', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}, {'ForeName': 'Gildo Barreira', 'Initials': 'GB', 'LastName': 'Furtado Gb', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System. Electronic address: gildofurtado@gmail.com.'}, {'ForeName': 'Alessandrino Terceiro', 'Initials': 'AT', 'LastName': 'Oliveira', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}, {'ForeName': 'Francisco Antônio', 'Initials': 'FA', 'LastName': 'Araújo Oliveira', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}, {'ForeName': 'Cibele Silveira', 'Initials': 'CS', 'LastName': 'Pinho', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Aguiar Sampaio', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}, {'ForeName': 'Ana Márcia', 'Initials': 'AM', 'LastName': 'Lima Feitosa', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ruver de Lima Herculano Junir', 'Affiliation': 'Service of Digestive Endoscopy of The General Hospital of Fortaleza from the The Unified Brazilian National Health System.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.11.007']
2788,33220323,Impact of Tafamidis on Health-Related Quality of Life in Patients with Transthyretin Amyloid Cardiomyopathy (From the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial).,"In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis significantly reduced all-cause mortality and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM is associated with a significant burden of disease; further analysis of patient-reported quality of life will provide additional data on the efficacy of tafamidis. In ATTR-ACT, 441 adult patients with ATTR-CM were randomized (2:1:2) to tafamidis 80 mg, tafamidis 20 mg, or placebo for 30 months, with pooled tafamidis (80 mg and 20 mg) compared with placebo. Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) domain scores, EQ-5D-3L scores, and patient global assessment (PGA), were prespecified exploratory end points. A greater proportion of patients improved KCCQ-OS score at month 30 with tafamidis (41.8%) versus placebo (21.4%). Tafamidis significantly reduced the decline in all 4 KCCQ-OS domains (p <0.0001 for all), and in EQ-5D-3L utility (0.09 [confidence interval 0.05 to 0.12]; p <0.0001) and EQ visual analog scale (9.11 [confidence interval 5.39 to 12.83]; p <0.0001) scores at month 30 versus placebo. A larger proportion of tafamidis-treated patients reported their PGA improved at month 30 (42.3% vs 23.8% with placebo). In conclusion, tafamidis effectively reduced the decline in patient-reported outcomes, providing further insight into its efficacy in health-related quality of life in patients with ATTR-CM. Clinical trial registration ClinicalTrials.gov: NCT01994889.",2020,"Tafamidis significantly reduced the decline in all 4 KCCQ-OS domains (p <0.0001 for all), and in EQ-5D-3L utility (0.09 [confidence interval 0.05 to 0.12]; p <0.0001) and EQ visual analog scale (9.11 [confidence interval 5.39 to 12.83]; p <0.0001) scores at month 30 versus placebo.","['441 adult patients with ATTR-CM', 'patients with transthyretin amyloid cardiomyopathy (ATTR-CM', 'Patients with Transthyretin Amyloid Cardiomyopathy ']","['tafamidis 80 mg, tafamidis 20 mg, or placebo', 'placebo']","['KCCQ-OS score', 'EQ-5D-3L utility', 'EQ visual analog scale', 'PGA', 'Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) domain scores, EQ-5D-3L scores, and patient global assessment (PGA', 'Health-Related Quality of Life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0268407', 'cui_str': 'Senile cardiac amyloidosis'}]","[{'cui': 'C2745274', 'cui_str': 'tafamidis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",441.0,0.347641,"Tafamidis significantly reduced the decline in all 4 KCCQ-OS domains (p <0.0001 for all), and in EQ-5D-3L utility (0.09 [confidence interval 0.05 to 0.12]; p <0.0001) and EQ visual analog scale (9.11 [confidence interval 5.39 to 12.83]; p <0.0001) scores at month 30 versus placebo.","[{'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Amyloidosis Center, Cleveland Clinic, Cleveland, OH, USA. Electronic address: HANNAM@ccf.org.'}, {'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Damy', 'Affiliation': 'French Referral Center for Cardiac Amyloidosis, Amyloidosis Mondor Network, GRC Amyloid Research Institute, and Department of Cardiology, all at APHP; CHU Henri Mondor, INSERM U955 and Clinical Investigation Center 006, and DHU ATVB, all at Créteil, France.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Balarama', 'Initials': 'B', 'LastName': 'Gundapaneni', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Terrell A', 'Initials': 'TA', 'LastName': 'Patterson', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Schwartz', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Marla B', 'Initials': 'MB', 'LastName': 'Sultan', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.10.066']
2789,33217726,Does Cold-Water Immersion After Strength Training Attenuate Training Adaptation?,"PURPOSE


Cold-water immersion is increasingly used by athletes to support performance recovery. Recently, however, indications have emerged suggesting that the regular use of cold-water immersion might be detrimental to strength training adaptation.
METHODS


In a randomized crossover design, 11 participants performed two 8-week training periods including 3 leg training sessions per week, separated by an 8-week ""wash out"" period. After each session, participants performed 10 minutes of either whole-body cold-water immersion (cooling) or passive sitting (control). Leg press 1-repetition maximum and countermovement jump performance were determined before (pre), after (post) and 3 weeks after (follow-up) both training periods. Before and after training periods, leg circumference and muscle thickness (vastus medialis) were measured.
RESULTS


No significant effects were found for strength or jump performance. Comparing training adaptations (pre vs post), small and negligible negative effects of cooling were found for 1-repetition maximum (g = 0.42; 95% confidence interval [CI], -0.42 to 1.26) and countermovement jump (g = 0.02; 95% CI, -0.82 to 0.86). Comparing pre versus follow-up, moderate negative effects of cooling were found for 1-repetition maximum (g = 0.71; 95% CI, -0.30 to 1.72) and countermovement jump (g = 0.64; 95% CI, -0.36 to 1.64). A significant condition × time effect (P = .01, F = 10.00) and a large negative effect of cooling (g = 1.20; 95% CI, -0.65 to 1.20) were observed for muscle thickness.
CONCLUSIONS


The present investigation suggests small negative effects of regular cooling on strength training adaptations.",2020,"Leg press 1-repetition maximum and countermovement jump performance were determined before (pre), after (post) and 3 weeks after (follow-up) both training periods.",['11 participants'],"['whole-body cold-water immersion (cooling) or passive sitting (control', 'Cold-Water Immersion']","['strength or jump performance', 'Leg press 1-repetition maximum and countermovement jump performance', 'leg circumference and muscle thickness (vastus medialis']",[],"[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}]",11.0,0.0388015,"Leg press 1-repetition maximum and countermovement jump performance were determined before (pre), after (post) and 3 weeks after (follow-up) both training periods.","[{'ForeName': 'Wigand', 'Initials': 'W', 'LastName': 'Poppendieck', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wegmann', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hecksteden', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Darup', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schimpchen', 'Affiliation': ''}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Skorski', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ferrauti', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kellmann', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pfeiffer', 'Affiliation': ''}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0965']
2790,33217744,"Erratum: IJPC. 2020; 24(4): 327 Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF PH4.","Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF PH4. IJPC. 2020; 24(4): 327; Abstract, 3rd line from bottom, should read: ""…doxycycline (2 mg/mL to 50 mg/mL) was stable…"" The concentration is correct in the remainder of the article.",2020,"Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF PH4.","['SyrSpend SF PH4', '2020; 24(4']","['IJPC', 'Tramadol, Fluoxetine, and Doxycycline Suspensions', 'doxycycline', 'Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions']",[],"[{'cui': 'C4058153', 'cui_str': 'SyrSpend SF'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",[],,0.0148325,"Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF PH4.",[],International journal of pharmaceutical compounding,[]
2791,33217785,Kidney Function and Cognitive Decline in Older Adults: Examining the Role of Neurodegeneration.,"BACKGROUND/OBJECTIVES


Cognitive decline associated with impaired kidney function might involve neurodegeneration. Our objectives were to evaluate the longitudinal association between kidney function and cognitive decline in older adults and to assess the involvement of cortical beta-amyloid and hippocampal atrophy (features of Alzheimer's disease (AD)) in this association.
DESIGN


Secondary analysis of the randomized controlled Multidomain Alzheimer Preventive Trial (MAPT).
SETTINGS


Thirteen memory centers (France and Monaco, 2008-2016).
PARTICIPANTS


A total of 1,334 community-dwellers >70 years old without dementia at baseline.
MEASUREMENTS


We estimated glomerular filtration rate (eGFR) from serum creatinine using CKD-Epi equation. Cognition was assessed at baseline, 6, 12, 24, 36, 48, and 60 months using a composite Z-score designed for MAPT. The Clinical Dementia Rating (CDR) score was used to assess cognition and functional independence. We examined the association between eGFR and (1) evolution of the composite cognitive Z-score using mixed-effect models and (2) progression on CDR using Cox models and mixed-effect models. Adjustments were made for age, sex, education, ApoE genotype, cardiovascular risk factors and disease, hippocampal volume (measured with magnetic resonance), and cortical beta-amyloid (measured with positron emission tomography).
RESULTS


Median (IQR) eGFR was 73(60-84) mL/min/1.73 m 2  . Two hundred sixty-nine participants experienced progression on CDR score during follow-up. eGFR<60 was significantly associated with progression on CDR score (adjusted hazard ratio (aHR) = 1.35, 95% CI 1.01-1.80) and with both the cognitive and functional independence components of CDR, but not with the evolution of the composite cognitive Z-score (adjusted β-coefficient -0.004, 95% CI -0.014; 0.006). Associations were not modified after further adjustment for beta-amyloid (subsample: n = 252) and hippocampal volume (subsample: n = 270).
CONCLUSIONS


We did not find a mild to moderate renal insufficiency to be associated with brain imaging features of AD, and our results do not support the involvement of AD mechanisms in the incidence of cognitive impairment and functional decline associated with chronic kidney disease.",2020,"eGFR<60 was significantly associated with progression on CDR score (adjusted hazard ratio (aHR) = 1.35, 95% CI 1.01-1.80) and with both the cognitive and functional independence components of CDR, but not with the evolution of the composite cognitive Z-score (adjusted β-coefficient -0.004, 95% CI -0.014; 0.006).","['older adults', 'Older Adults', 'Two hundred sixty-nine participants experienced', 'Thirteen memory centers (France and Monaco, 2008-2016', 'A total of 1,334 community-dwellers >70\u2009years old without dementia at baseline']",[],"['glomerular filtration rate (eGFR', 'Clinical Dementia Rating (CDR) score', 'CDR score', 'progression on CDR score', 'Cognition', 'Kidney Function and Cognitive Decline', 'cardiovascular risk factors and disease, hippocampal volume (measured with magnetic resonance), and cortical beta-amyloid (measured with positron emission tomography']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0026405', 'cui_str': 'Monaco'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4304227', 'cui_str': 'CDR (Clinical Dementia Rating) score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}]",1334.0,0.125758,"eGFR<60 was significantly associated with progression on CDR score (adjusted hazard ratio (aHR) = 1.35, 95% CI 1.01-1.80) and with both the cognitive and functional independence components of CDR, but not with the evolution of the composite cognitive Z-score (adjusted β-coefficient -0.004, 95% CI -0.014; 0.006).","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Guerville', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'De Souto Barreto', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Coley', 'Affiliation': 'UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Mangin', 'Affiliation': ""Neurospin, Centre d'Energie Atomique Saclay, Gif-sur-Yvette, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Chupin', 'Affiliation': ""Institut du Cerveau et de la Moelle Epinière, Centre d'Acquisition et de Traitement d'Image pour la maladie d'Alzheimer (CATI), Inserm U1127, CNRS UMR 7225, Sorbonne Universités, UPMC, Univ. Paris 6, Paris, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Payoux', 'Affiliation': 'Nuclear Medicine Department, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Ousset', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Geriatrics Society,['10.1111/jgs.16954']
2792,33220095,Acute metabolic effects of melatonin - a randomized crossover study in healthy young men.,"Melatonin regulates circadian rhythm, but may also have effects on glucose-homeostasis. A common G-allele in the MTNR1B-locus has been associated with an increased risk of type 2 diabetes (T2DM). We aimed to examine acute effects of high doses of melatonin on glucose-metabolism with attention to MTNR1B genotype. Twenty men were examined in a double-blinded, randomized crossover study on two non-consecutive days with four doses of 10 mg oral melatonin or placebo. Insulin sensitivity and insulin secretion were assessed by an intravenous-glucose-tolerance-test (IVGTT) and a hyperinsulinemic euglycemic clamp (HEC). Blood samples were drawn to determine the metabolic profile and MTNR1B-rs10830963 genotype. Indirect calorimetry and blood pressure measurements were also performed. Insulin sensitivity index, was significantly reduced on the melatonin day (P=0.028) in the whole group and in homozygous carriers of the rs10830963 C-allele (p=0.041). Glucose during the IVGTT was unaffected, but there was a tendency towards lower insulin and C-peptide levels in the first minutes after glucose administration in G-allele carriers. Systolic blood pressure decreased and lipid-oxidation increased significantly on the melatonin day in rs10830963 G-allele carriers. Overall, our study reports that acute administration of melatonin in supra-physiological doses may have a negative impact on insulin sensitivity.",2020,Systolic blood pressure decreased and lipid-oxidation increased significantly on the melatonin day in rs10830963 G-allele carriers.,"['Twenty men', 'healthy young men']","['melatonin', 'hyperinsulinemic euglycemic clamp (HEC', 'Melatonin', 'melatonin or placebo']","['Systolic blood pressure decreased and lipid-oxidation', 'Indirect calorimetry and blood pressure measurements', 'Insulin sensitivity and insulin secretion', 'lower insulin and C-peptide levels', 'Insulin sensitivity index', 'Glucose', 'Acute metabolic effects']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",20.0,0.345836,Systolic blood pressure decreased and lipid-oxidation increased significantly on the melatonin day in rs10830963 G-allele carriers.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Kampmann', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben S', 'Initials': 'ES', 'LastName': 'Lauritzen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Grarup', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical research laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}]",Journal of pineal research,['10.1111/jpi.12706']
2793,33220115,Effectiveness of training stop-smoking advisers to deliver cessation support to the UK national proposed standard versus usual care in Malaysia: a two-arm cluster randomised controlled trial.,"AIM


To assess the effectiveness of training stop smoking service providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) Standard Treatment Programme compared with usual care.
DESIGN


Two-arm cluster randomised controlled effectiveness trial across 19 sites with follow-up at 4 weeks, 3 months, and 6 months.
SETTING


Stop smoking services operating in public hospitals in Malaysia.
PARTICIPANTS


502 smokers (mean[SD] age 45.6[13.4] years; 97.4% male) attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition.
INTERVENTION AND COMPARATOR


The intervention consisted of training stop-smoking practitioners to deliver support and follow-up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow-up).
MEASUREMENTS


The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired-air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO-verified tobacco smoking abstinence up to 4 weeks and 3 months.
RESULTS


Follow-up rates at 4 weeks, 3 months and 6 months were 80.0%, 70.6%, and 53.3% respectively in the intervention group and 48.8%, 30.8%, and 23.3% respectively in the control group. At 6-month follow-up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2% versus 11.0% in an intention-to-treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8% vs. 47.5% in a follow-up-only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04 (95%CI:1.22-20.77, p=0.025) and 1.70 (95%CI:0.25-11.53, p=0.589) in the ITT and FUO analyses respectively. Abstinence rates at 4-week and 3-month follow-ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis.
CONCLUSIONS


On an intention-to-treat analysis with missing-equals-smoking imputation, training Malaysian stop smoking service providers in the 'UK National Centre for Smoking Cessation and Training Standard Treatment Programme' appeared to increase 6-month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow-up rates.",2020,"Abstinence rates at 4-week and 3-month follow-ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis.
","['Stop smoking services operating in public hospitals in Malaysia', 'Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT', '502 smokers (mean[SD] age 45.6[13.4] years; 97.4% male) attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition', 'Malaysia']","['training stop-smoking practitioners to deliver support and follow-up according to the NCSCT Standard Treatment Programme', 'training stop-smoking advisers']","['continuous CO-verified tobacco smoking abstinence', 'Abstinence rates', 'continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired-air carbon monoxide (CO) concentration']","[{'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",502.0,0.049221,"Abstinence rates at 4-week and 3-month follow-ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis.
","[{'ForeName': 'Lei Hum', 'Initials': 'LH', 'LastName': 'Wee', 'Affiliation': 'Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Tee Guat', 'Initials': 'TG', 'LastName': 'Hiong', 'Affiliation': 'Institute for Public Health, Ministry of Health, Malaysia.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Yeap', 'Affiliation': 'Stats Consulting Sdn. Bhd., Malaysia.'}, {'ForeName': 'Caryn Mei Hsien', 'Initials': 'CMH', 'LastName': 'Chan', 'Affiliation': 'Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ho Bee', 'Initials': 'HB', 'LastName': 'Kiau', 'Affiliation': 'Bandar Botanic Health Centre, Ministry of Health, Malaysia.'}, {'ForeName': 'Komathi', 'Initials': 'K', 'LastName': 'Perialathan', 'Affiliation': 'Institute of Health Behavioural Research, Ministry of Health, Malaysia.'}, {'ForeName': 'Mohamad Haniki Nik', 'Initials': 'MHN', 'LastName': 'Mohamed', 'Affiliation': 'International Islamic University, Malaysia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Jackson', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15346']
2794,33220122,The Rewarding Recovery Study: A Randomized Controlled Trial of Incentives for Alcohol and Drug Abstinence with a Rural American Indian Community.,"AIMS


To test if contingency management (CM) interventions for alcohol and drug abstinence were associated with increased alcohol and drug abstinence among American Indian adults with alcohol dependence who also use drugs.
DESIGN


In this 2x2 factorial randomized controlled trial, American Indian adults with alcohol dependence, who also used drugs, were randomized to four conditions: 1) incentives for submission of urine samples only (control condition), 2) CM incentives for alcohol abstinence, 3) CM incentives for drug abstinence, or 4) CM incentives for abstinence from both alcohol and drugs.
SETTING


A Northern Plains Reservation in the United States.
PARTICIPANTS


114 American Indian adults aged 35.8 years [10.4]; 51% [n=58] were female.
INTERVENTION AND COMPARATOR


Participants received incentives if they demonstrated abstinence from alcohol (CM for alcohol, n=30), abstinence from their most frequently used drug (CM for drugs, n=27) or abstinence from both alcohol and their most frequently used drug (CM for alcohol and drugs, n=32) as assessed by urine tests. Controls (n=25) received incentives for submitting urine samples only.
MEASUREMENTS


Primary outcomes were urine ethyl glucuronide (alcohol) and drug tests conducted three times per week during the 12-week intervention period. Data analyses included listwise deletion and multiple imputation to account for missing data.
FINDINGS


The three CM groups were significantly (p<.05) more likely to submit alcohol abstinent urine samples compared with the control condition, with odds ratios ranging from 2.4 to 4.8. The CM for drugs and CM for alcohol and drugs groups were more likely to submit urine samples that indicated drug abstinence, with odds ratios ranging from 2.5 to 3.2, than the CM for alcohol, but these differences were not significant in multiple imputation analyses (p>.05).
CONCLUSIONS


Contingency management (CM) incentives for abstinence were associated with increased alcohol abstinence in American Indian adults diagnosed with alcohol dependence who also used drugs, living on a rural reservation. The effect of CM incentives on drug abstinence was inconclusive.",2020,"The three CM groups were significantly (p<.05) more likely to submit alcohol abstinent urine samples compared with the control condition, with odds ratios ranging from 2.4 to 4.8.","['A Northern Plains Reservation in the United States', 'American Indian adults with alcohol dependence who also use drugs', 'Rural American Indian Community', 'American Indian adults diagnosed with alcohol dependence who also used drugs, living on a rural reservation', '114 American Indian adults aged 35.8 years [10.4]; 51% [n=58] were female', 'American Indian adults with alcohol dependence, who also used drugs, were randomized to four conditions: 1']","['Contingency management (CM) incentives', 'incentives if they demonstrated abstinence from alcohol (CM for alcohol, n=30), abstinence from their most frequently used drug (CM for drugs, n=27) or abstinence from both alcohol and their most frequently used drug (CM for alcohol and drugs', 'contingency management (CM) interventions', 'incentives for submission of urine samples only (control condition), 2) CM incentives for alcohol abstinence, 3) CM incentives for drug abstinence, or 4) CM incentives for abstinence from both alcohol and drugs']","['alcohol abstinence', 'urine ethyl glucuronide (alcohol']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}]","[{'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0298229', 'cui_str': 'Ethyl glucuronide'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",114.0,0.0250307,"The three CM groups were significantly (p<.05) more likely to submit alcohol abstinent urine samples compared with the control condition, with odds ratios ranging from 2.4 to 4.8.","[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skalisky', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Burduli', 'Affiliation': 'Program for Excellence in Addiction Research, Washington State University, Spokane, WA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Foote', 'Affiliation': 'Institute for Research and Education to Advance Community Health and Partnerships for Native Health, Washington State University.'}, {'ForeName': 'Alexandria', 'Initials': 'A', 'LastName': 'Granbois', 'Affiliation': 'Institute for Research and Education to Advance Community Health and Partnerships for Native Health, Washington State University.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Smoker', 'Affiliation': 'Institute for Research and Education to Advance Community Health and Partnerships for Native Health, Washington State University.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hirchak', 'Affiliation': 'Center on Alcoholism, Substance Abuse and Addictions, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Jalene', 'Initials': 'J', 'LastName': 'Herron', 'Affiliation': 'Center on Alcoholism, Substance Abuse and Addictions, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Echo-Hawk', 'Affiliation': 'Urban Indian Health Institute, Seattle, WA.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'Program for Excellence in Addiction Research, Washington State University, Spokane, WA.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Institute for Research and Education to Advance Community Health and Partnerships for Native Health, Washington State University.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roll', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA.'}, {'ForeName': 'Sterling M', 'Initials': 'SM', 'LastName': 'McPherson', 'Affiliation': 'Institute for Research and Education to Advance Community Health and Partnerships for Native Health, Washington State University.'}]","Addiction (Abingdon, England)",['10.1111/add.15349']
2795,33220141,The Efficacy of Dental Sealant Used with Bonding Agent on Occlusal Caries (ICDAS 2-4): A 24-Month Randomized Clinical Trial.,"BACKGROUND


Bonding before sealant application enhances retention on saliva-contaminated sound teeth; however, there are few studies of bonding's efficacy on sealant retention on occlusal caries.
AIM


To evaluate a bonding agent's efficacy on sealant retention on occlusal caries and caries-transition.
DESIGN


One hundred twenty pairs of first permanent molars with occlusal caries (ICDAS 2-4) from 98 children aged 7.3-9.9 years were included. One molar was randomly selected to use bonding (Adper™ Single Bond 2, 3M ESPE) applied before sealant application (Helioseal®clear, Ivoclar Vivadent). Bonding was not used on the contralateral tooth. Retention was determined using Simonsen's criteria, caries-transition was evaluated using ICDAS scores, DIAGNOdent values, and bitewings at baseline, 6-, 12-, and 24-months. Data were analyzed with McNemar '  s and Fisher's exact tests.
RESULTS


Bonding agent use significantly increased sealant retention rates (p<.001). Bonded (B) sealants had a higher retention rate (83.3%) than nonbonded (NB) sealants (53.7%). The difference in the caries-transition rate was not significant between the groups (p>.05). Three teeth (1.4%; NB:B=2:1) were restored due to radiographic dentin-caries progression.
CONCLUSIONS


Using a bonding agent before applying sealant on permanent molar occlusal caries (ICDAS 2-4) significantly enhanced sealant retention. Caries progression was rarely detected at the 24-month follow-up.",2020,Bonded (B) sealants had a higher retention rate (83.3%) than nonbonded (NB) sealants (53.7%).,"['One hundred twenty pairs of first permanent molars with occlusal caries (ICDAS 2-4) from 98 children aged 7.3-9.9 years were included', 'Occlusal Caries (ICDAS 2-4']","['bonding (Adper™ Single Bond 2, 3M ESPE) applied before sealant application (Helioseal®clear, Ivoclar Vivadent', 'Dental Sealant Used with Bonding Agent']","['Caries progression', 'sealant retention rates', 'retention rate', 'radiographic dentin-caries progression', 'caries-transition rate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0759863', 'cui_str': 'single bond'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0062181', 'cui_str': 'Helioseal'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0031992', 'cui_str': 'Pit Fissure Sealants'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}]",98.0,0.0770534,Bonded (B) sealants had a higher retention rate (83.3%) than nonbonded (NB) sealants (53.7%).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kasemkhun', 'Affiliation': 'Department of Pediatric Dentistry, Mahidol University, Ratchathewi District, No.6, Yothi road, Bangkok, 10400, Thailand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nakornchai', 'Affiliation': 'Department of Pediatric Dentistry, Mahidol University, Ratchathewi District, No.6, Yothi road, Bangkok, 10400, Thailand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Phonghanyudh', 'Affiliation': 'Department of Pediatric Dentistry, Mahidol University, Ratchathewi District, No.6, Yothi road, Bangkok, 10400, Thailand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Srimaneekarn', 'Affiliation': 'Department of Anatomy, Mahidol University, Ratchathewi District, No.6, Yothi road, Bangkok, 10400, Thailand.'}]",International journal of paediatric dentistry,['10.1111/ipd.12758']
2796,33220326,Thermo-behavioural responses to orally applied L-menthol exhibit sex-specific differences during exercise in a hot environment.,"AIMS


This study investigated the efficacy of L-menthol mouth-rinsing on thermal sensation and perceived effort in females and males, using a fixed-rating of perceived exertion (RPE) exercise protocol in a hot environment.
METHODS


Twenty-two participants (eleven females, eleven males) completed two trials using a fixed-RPE protocol at an exercise intensity between 'hard' and 'very hard', equating to 16 on the RPE scale at ∼35°C. Participants adjusted power output to maintain RPE-16. In a randomised, double-blind, crossover design, L-menthol or a control mouthwash was administered at an orally neutral temperature (∼32 °C) prior to exercise and at 10 min intervals thereafter. Measures of mechanical power output, core temperature, heart rate, perception of thermal sensation and thermal comfort, and whole-body sweat loss are reported.
RESULTS


Thermal sensation was lowered by L-menthol in both sexes (P < 0.05), however during exercise this was only maintained for 40% of the trial duration in females. Thermal comfort did not differ between conditions (P > 0.05). No differences in exercise duration were observed compared to control, despite a ∼4 % and ∼6 % increase in male and females respectively. Power output increased by ∼6.5 % males (P = 0.039) with no difference in females ∼2.2% (P = 0.475), compared to control. Core temperature, heart rate and whole-body sweat loss was not different between condition or sex.
CONCLUSIONS


L-menthol lowered perceptual measures of thermal sensation in females, but did not attenuate a greater rate of rise in thermal sensitivity when exercising in a hot environment, compared to males. Males appeared to adopt a higher risk strategy by increasing power output following L-menthol administration in contrast to a more conservative pacing strategy in females. Therefore, there appear to be sex-specific differences in L-menthol's non-thermal cooling properties and subsequent effects on thermo-behavioural adjustments in work-load when exercising in a hot environment.",2020,"Power output increased by ∼6.5 % males (P = 0.039) with no difference in females ∼2.2% (P = 0.475), compared to control.","['Twenty-two participants (eleven females, eleven males', 'females and males, using a fixed-rating of perceived exertion (RPE) exercise protocol in a hot environment']","['fixed-RPE protocol', 'L-menthol', 'L-menthol or a control mouthwash', 'L-menthol mouth-rinsing']","['mechanical power output, core temperature, heart rate, perception of thermal sensation and thermal comfort, and whole-body sweat loss', 'Thermal sensation', 'Thermal comfort', 'Core temperature, heart rate and whole-body sweat loss', 'Power output', 'exercise duration']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0241922', 'cui_str': 'Hot environment'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0771655', 'cui_str': 'LEVOMENTHOL'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",22.0,0.0815576,"Power output increased by ∼6.5 % males (P = 0.039) with no difference in females ∼2.2% (P = 0.475), compared to control.","[{'ForeName': 'Abbie Jayne', 'Initials': 'AJ', 'LastName': 'Parton', 'Affiliation': 'School of Biomedical, Nutritional and Sport Sciences, Newcastle University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Waldron', 'Affiliation': 'College of Engineering, Swansea University, Swansea, UK; School of Science and Technology, University of New England, Armidale, NSW, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Clifford', 'Affiliation': 'School of Sport, Health and Exercise Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Jeffries', 'Affiliation': 'School of Biomedical, Nutritional and Sport Sciences, Newcastle University, Newcastle Upon Tyne, UK. Electronic address: owen.jeffries@newcastle.ac.uk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113250']
2797,33220329,The effects of medium chain triglyceride (MCT) supplementation using a C 8 :C 10  ratio of 30:70 on cognitive performance in healthy young adults.,"PURPOSE


The brain can utilise medium chain triglycerides (MCTs) as an alternative fuel than glucose, and research has shown that MCT ingestion improves cognitive function in diseased and/or elderly individuals. The aim of this study is to determine if these improvements can also be observed in young, healthy adults. Furthermore, we aim to establish the ideal dosage and timeframe necessary for an effect.
METHODS


Participants were divided equally into three groups of 10 (Placebo (0g), 12g and 18g MCT/day) and were supplemented for 4 weeks. The supplement had a C 8 :C 10  ratio of 30:70. Participants visited the laboratory once a week for 5 weeks (baseline, test weeks 1-4) to undergo a battery of cognitive tests; Trail Making, Digit Span, Spatial Span, Covert Shift of Attention, and Rapid Visual Information Processing.
RESULTS


After 2-3 weeks of supplementation, MCT ingestion enhanced performance in cognitive tasks, including: Trail Making A/B and Digit Span Forwards/Backwards (ps<0.001) when compared to a placebo group taking a carbohydrate gel. In Spatial Span Backwards, there was a significant main effect of group (p=0.002). Where significance was seen, there were main effects of time after 2-3 weeks (ps<0.05). There was minimal difference between the two MCT intervention groups in most measures (ps>0.05). There were also null results in tasks measuring attention and reaction time (ps>0.05).
CONCLUSIONS


MCT ingestion improved cognitive performance after 2-3 weeks, with minimal difference between taking 12g and 18g MCT/day groups, suggesting a possible dose-response threshold at 12g MCT/day when supplementing over a short period.",2020,"Where significance was seen, there were main effects of time after 2-3 weeks (ps<0.05).","['healthy young adults', 'young, healthy adults', 'Participants', 'diseased and/or elderly individuals']","['10 (Placebo', 'carbohydrate gel', 'supplementation, MCT ingestion', 'placebo', 'MCT ingestion', 'MCT intervention', 'Spatial Span', 'medium chain triglyceride (MCT) supplementation']","['Digit Span, Spatial Span, Covert Shift of Attention, and Rapid Visual Information Processing', 'cognitive performance', 'cognitive function', 'cognitive tasks, including: Trail Making A/B and Digit Span Forwards', 'tasks measuring attention and reaction time (ps>0.05']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556090', 'cui_str': 'Medium chain triglyceride supplementation'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0588978', 'cui_str': 'Digit span forwards'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0691031,"Where significance was seen, there were main effects of time after 2-3 weeks (ps<0.05).","[{'ForeName': 'Jake S', 'Initials': 'JS', 'LastName': 'Ashton', 'Affiliation': 'School of Health Sciences, Liverpool Hope University, Liverpool, UK.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Roberts', 'Affiliation': 'School of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Wakefield', 'Affiliation': 'School of Health Sciences, Liverpool Hope University, Liverpool, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Page', 'Affiliation': 'Department of Sport and Physical Activity, Edge Hill University, Ormskirk, UK.'}, {'ForeName': 'Don P M', 'Initials': 'DPM', 'LastName': 'MacLaren', 'Affiliation': 'School of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marwood', 'Affiliation': 'School of Health Sciences, Liverpool Hope University, Liverpool, UK.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Malone', 'Affiliation': 'School of Health Sciences, Liverpool Hope University, Liverpool, UK. Electronic address: malonej2@hope.ac.uk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113252']
2798,33220353,"A Randomized Double-Blinded, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis.","BACKGROUND


Idiopathic anaphylaxis (IA) is a diagnosis of exclusion, thus taking away the option of therapeutic management focused on eliminating the inciting agent. Epinephrine and antihistamines followed by systemic corticosteroids are the mainstays of therapy for acute events. There is no prophylactic therapy that reliably prevents anaphylaxis.
OBJECTIVE


We sought to determine the efficacy of omalizumab in the management of patients with frequent episodes of IA in a DBPC trial.
METHODS


We prospectively enrolled 19 patients with frequent IA (≥6 episodes/yr) and who then underwent a medical evaluation that included a serum tryptase determination, mutational analysis for KIT D816V and bone marrow evaluation to rule out a clonal mast cell disorder. Computer-generated random numbers were provided by the study pharmacist. The primary endpoint was anaphylactic events in the 6 months after baseline. Sixteen patients completed the primary trial.
RESULTS


No statistically significant difference was demonstrated between the placebo and treated groups. There was a trend for efficacy in the treatment group, particularly after 60 days. Overall, the safety profile was favorable without long-term side effects.
CONCLUSION


Omalizumab was safely administered to a difficult to treat patient population with IA. The efficacy results trended modestly in favor of the treatment group, but no statistically significant differences were detected.
CLINICAL TRIALS NUMBER


NCT00890162.",2020,No statistically significant difference was demonstrated between the placebo and treated groups.,"['Sixteen patients completed the primary trial', 'patients with frequent episodes of IA in a DBPC trial', '19 patients with frequent IA (≥6 episodes/yr) and who then underwent a medical evaluation that included a serum tryptase determination, mutational analysis for KIT D816V and bone marrow evaluation to rule out a clonal mast cell disorder']","['placebo', 'omalizumab', 'Placebo', 'Omalizumab', 'Epinephrine and antihistamines']","['anaphylactic events', 'safety profile', 'efficacy']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0147080', 'cui_str': 'Tryptase'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0024899', 'cui_str': 'Mast cell hyperplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19.0,0.33268,No statistically significant difference was demonstrated between the placebo and treated groups.,"[{'ForeName': 'Melody C', 'Initials': 'MC', 'LastName': 'Carter', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Electronic address: mcarter@niaid.nih.gov.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Maric', 'Affiliation': 'Hematology Section, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Erica H', 'Initials': 'EH', 'LastName': 'Brittain', 'Affiliation': 'Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Lumbard', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Hyejeong', 'Initials': 'H', 'LastName': 'Bolan', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Daly', 'Initials': 'D', 'LastName': 'Cantave', 'Affiliation': 'Department of Nursing, Clinical Center, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Scott', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Dean D', 'Initials': 'DD', 'LastName': 'Metcalfe', 'Affiliation': 'Mast Cell Biology Section, Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.11.005']
2799,33220395,"Erlotinib vs etoposide/cisplatin with radiotherapy in unresectable stage III epidermal growth factor receptor mutation-positive non-small-cell lung cancer: A multicenter, randomized, open-label, phase 2 trial.","PURPOSE


This study aimed to compare erlotinib (E) and etoposide/cisplatin (EP) with concurrent radiotherapy (RT) for patients with stage IIIA/B unresectable advanced non-small-cell lung cancer (NSCLC) with activating epidermal growth factor receptor mutation (EGFRm+).
METHODS


and patients: This was a multicenter, randomized, open-label, phase 2 trial conducted across 19 institutions in China (December 2012 to January 2016). Enrolled patients were randomized (1:1) to E+RT (oral erlotinib 150 mg/day for 2 years or until disease progression or intolerable toxicity and RT 200 cGy/day, 5 days/week for 6 weeks from the first day of erlotinib) or EP+RT (etoposide 50 mg/m 2  intravenously on days 1-5 and 29-33; cisplatin 50 mg/m 2  intravenously on days 1, 8, 29 and 36; and RT as above). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR) and safety.
RESULTS


A total of 252 patients were screened and 20 patients with EGFRm+ in each group received the allocated E+RT or EP+RT treatment. Patient characteristics were well-balanced between groups. Compared with EP+RT, median PFS with E+RT was significantly longer (24.5 vs 9.0 months [hazard ratio, 0.104; 95% confidence interval, 0.028-0.389; P < 0.001]). ORR in the E+RT and EP+RT groups was 70% and 61.9%, respectively (P = 0.744). The incidence of adverse events (any grade) was similar between E+RT and EP+RT groups (88.9% and 84.2%).
CONCLUSIONS


The primary endpoint of PFS was met, and the data showed that E+RT might provide PFS improvement compared with EP+RT, with similar tolerability. However, definitive statements regarding the efficacy of concurrent E+RT in patients with unresectable stage III NSCLC with activating EGFRm+ cannot be made, and slow patient accrual will likely make it infeasible to conduct a phase 3 study.",2020,"Compared with EP+RT, median PFS with E+RT was significantly longer (24.5 vs 9.0 months [hazard ratio, 0.104; 95% confidence interval, 0.028-0.389; P < 0.001]).","['patients with unresectable stage III NSCLC with activating', 'patients with stage IIIA/B unresectable advanced non-small-cell lung cancer (NSCLC) with activating epidermal growth factor receptor mutation (EGFRm', '252 patients were screened and 20 patients with', 'and patients', '19 institutions in China (December 2012 to January 2016', 'unresectable stage III epidermal growth factor receptor mutation-positive non-small-cell lung cancer']","['concurrent E+RT', 'E+RT (oral erlotinib', 'EP+RT (etoposide 50 mg/m 2  intravenously on days 1-5 and 29-33; cisplatin', 'E+RT', 'EGFRm', 'E+RT or EP+RT treatment', 'Erlotinib vs etoposide/cisplatin with radiotherapy', 'erlotinib (E) and etoposide/cisplatin (EP) with concurrent radiotherapy (RT']","['incidence of adverse events', 'ORR', 'median PFS with E+RT', 'tolerability', 'objective response rate (ORR) and safety', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0985926', 'cui_str': 'Etoposide 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1880476', 'cui_str': 'PE regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",252.0,0.155706,"Compared with EP+RT, median PFS with E+RT was significantly longer (24.5 vs 9.0 months [hazard ratio, 0.104; 95% confidence interval, 0.028-0.389; P < 0.001]).","[{'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'Department of Radiation Oncology and Shandong Key Laboratory of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Cancer Center, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Luhua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Fujian Provincial Cancer Hospital, Clinical College of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Zhengzhou University Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': ""Department of Radiation Oncology, CyberKnife Center, Tianjin Medical University Cancer Institute & Hospital, Key Laboratory of Cancer Prevention and Therapy, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Tianjin, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhengfei', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Oncology, Huaxi Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Oncology, Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Tingyi', 'Initials': 'T', 'LastName': 'Xia', 'Affiliation': 'Department of Radiation Oncology, Air Force General Hospital, Beijing, China.'}, {'ForeName': 'Conghua', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Department of Oncology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Radiation Oncology, Guizhou Cancer Hospital, Guiyang, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, First Affiliated Hospital of Xiamen University, Xiamen, China.'}, {'ForeName': 'Guangying', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Baolin', 'Initials': 'B', 'LastName': 'Qu', 'Affiliation': 'Department of Radiation Oncology, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wanqi', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology and Shandong Key Laboratory of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China.'}, {'ForeName': 'Jinming', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology and Shandong Key Laboratory of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, China. Electronic address: sdyujinming@126.com.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.11.026']
2800,32692805,Effectiveness of a normative nutrition intervention in Chilean pregnant women on maternal and neonatal outcomes: the CHiMINCs study.,"BACKGROUND


Some nutritional interventions have shown their efficacy in reducing gestational weight gain (GWG); however, their applicability in routine care is limited.
OBJECTIVE


We assessed the effectiveness of a low-intensity and high-coverage nutritional intervention on maternal and offspring outcomes; the intervention enhanced existing nutritional health care standards and practices at the primary health care level in Chile.
METHODS


This study was a cluster-randomized controlled trial of 12 primary health care centers (PHCCs) from Santiago, Chile. PHCCs were randomly allocated to either nutritional intervention [intervention group (IG), n = 5] or routine care [control group (CG), n = 7]. A total of 4631 pregnant women were recruited (IG, n = 2565; and CG, n = 2066). Primary outcomes were adequate GWG and glycemic control in mothers and birth weight, birth length, macrosomia, and large for gestational age in neonates. The intervention consisted of 4 key actions: training of health care professionals on nutritional recommendations, counseling of pregnant women on diet and physical activity recommendations, offering a physical activity program implemented in the participating PHCCs, and adequate referral to dietitians. Women randomly assigned to the CG received routine antenatal care.
RESULTS


At baseline, the mean age was 26.1 y; 45% of women were primipara and 24% were obese. No differences were found in the percentage of women achieving adequate GWG (IG: 30.3%, compared with CG: 31.3%; OR: 0.94; 95% CI: 0.81, 1.09), but women in the IG had lower GWG than those in the CG (11.3 compared with 11.9 kg; mean difference: -0.63 kg; 95% CI: -1.19, -0.08). Effects of the intervention were significantly higher in women with obesity at the begining of pregnancy (mean difference: -1.24 kg; 95% CI: -2.18, -0.30; P for interaction < 0.05). No differences were found between groups regarding maternal glycemic control or neonatal outcomes.
CONCLUSIONS


Our findings demonstrate that a low-intensity, high-coverage intervention delivered through the Chilean public health care system under standard operating conditions reduces GWG and has the potential for successful scale-up. This trial was registered at clinicaltrials.gov as NCT01916603.",2020,"No differences were found between groups regarding maternal glycemic control or neonatal outcomes.
","['4631 pregnant women were recruited (IG, n\xa0=\xa02565; and CG, n\xa0=\xa02066', 'mean age was 26.1 y; 45% of women were primipara and 24% were obese', '12 primary health care centers (PHCCs) from Santiago, Chile', 'Chilean pregnant women on maternal and neonatal outcomes']","['low-intensity and high-coverage nutritional intervention', 'CG received routine antenatal care', 'normative nutrition intervention', '4 key actions: training of health care professionals on nutritional recommendations, counseling of pregnant women on diet and physical activity recommendations, offering a physical activity program implemented in the participating PHCCs, and adequate referral to dietitians', 'nutritional intervention [intervention group (IG), n\xa0=\xa05] or routine care [control group (CG), n\xa0=\xa07']","['gestational weight gain (GWG', 'percentage of women achieving adequate GWG', 'maternal glycemic control or neonatal outcomes', 'adequate GWG and glycemic control in mothers and birth weight, birth length, macrosomia, and large for gestational age in neonates']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008107', 'cui_str': 'Chile'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0420347', 'cui_str': 'Patient referral to dietitian'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0419415', 'cui_str': 'Birth length'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",4631.0,0.127877,"No differences were found between groups regarding maternal glycemic control or neonatal outcomes.
","[{'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Garmendia', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Corvalan', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Araya', 'Affiliation': 'Department of Women and Newborn Health Promotion, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Casanello', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Kusanovic', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Uauy', 'Affiliation': 'Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa185']
2801,32694216,Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program.,"BACKGROUND


Traditionally, clinical trials evaluating effects of a new therapy with creatinine-based renal end points use doubling of serum creatinine (equivalent to a 57% eGFR reduction), requiring large sample sizes.
METHODS


To assess whether eGFR declines <57% could detect canagliflozin's effects on renal outcomes, we conducted a  post hoc  study comparing effects of canagliflozin versus placebo on composite renal outcomes using sustained 57%, 50%, 40%, or 30% eGFR reductions in conjunction with ESKD and renal death. Because canagliflozin causes an acute reversible hemodynamic decline in eGFR, we made estimates using all eGFR values as well as estimates that excluded early measures of eGFR influenced by the acute hemodynamic effect.
RESULTS


Among the 10,142 participants, 93 (0.9%), 161 (1.6%), 352 (3.5%), and 800 (7.9%) participants recorded renal outcomes on the basis of 57%, 50%, 40%, or 30% eGFR reduction, respectively, during a mean follow-up of 188 weeks. Compared with a 57% eGFR reduction (risk ratio [RR], 0.51; 95% confidence interval [95% CI], 0.34 to 0.77), the effect sizes were progressively attenuated when using 50% (RR, 0.61; 95% CI, 0.45 to 0.83), 40% (RR, 0.70; 95% CI, 0.57 to 0.86), or 30% (RR, 0.81; 95% CI, 0.71 to 0.93) eGFR reductions. In analyses that controlled for the acute hemodynamic fall in eGFR, effect sizes were comparable, regardless of whether a 57%, 50%, 40%, or 30% eGFR reduction was used. Estimated sample sizes for studies on the basis of lesser eGFR reductions were much reduced by controlling for this early hemodynamic effect.
CONCLUSIONS


Declines in eGFR <57% may provide robust estimates of canagliflozin's effects on renal outcomes if the analysis controls for the drug's acute hemodynamic effect.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


CANagliflozin cardioVascular Assessment Study (CANVAS), NCT01032629 and CANVAS-R, NCT01989754.",2020,"Compared with a 57% eGFR reduction (risk ratio [RR], 0.51; 95% confidence interval [95% CI], 0.34 to 0.77), the effect sizes were progressively attenuated when using 50% (RR, 0.61; 95% CI, 0.45 to 0.83), 40% (RR, 0.70; 95% CI, 0.57 to 0.86), or 30% (RR, 0.81; 95% CI, 0.71 to 0.93) eGFR reductions.",[],"['canagliflozin versus placebo', 'Canagliflozin']","['renal death', 'renal outcomes', 'effect sizes', 'composite renal outcomes']",[],"[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",10142.0,0.280517,"Compared with a 57% eGFR reduction (risk ratio [RR], 0.51; 95% confidence interval [95% CI], 0.34 to 0.77), the effect sizes were progressively attenuated when using 50% (RR, 0.61; 95% CI, 0.45 to 0.83), 40% (RR, 0.70; 95% CI, 0.57 to 0.86), or 30% (RR, 0.81; 95% CI, 0.71 to 0.93) eGFR reductions.","[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'Department of Renal and Metabolic, The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'Department of Renal and Metabolic, The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'Department of Renal and Metabolic, The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Renal and Metabolic, The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Renal and Metabolic, The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Royal North Shore Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Canovatchel', 'Affiliation': 'Janssen Global Services, LLC, Raritan, New Jersey.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Harris Manchester College, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Department of Renal and Metabolic, The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia vlado.perkovic@unsw.edu.au.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019121312']
2802,32700954,A multiple baseline study of a brief alcohol reduction and family engagement intervention for fathers in Kenya.,"OBJECTIVE


To evaluate a lay provider-delivered, brief intervention to reduce problem drinking and related family consequences among men in Kenya. The 5-session intervention combines behavioral activation (BA) and motivational interviewing (MI). It integrates family-related material explicitly and addresses central cultural factors through gender transformative strategies.
METHOD


A nonconcurrent multiple-baseline design was used. We initiated treatment with 9 men ages 30 to 48 who were fathers and screened positive for problem drinking; the median Alcohol Use Identification Test score was 17 (harmful range). Participants were randomized to staggered start dates. We measured the primary outcome of weekly alcohol consumption 4 weeks before treatment, during treatment, and 4 weeks posttreatment using the Timeline Followback measure. Secondary outcomes were assessed using a pre-post assessment (1-month) of men's depression symptoms, drinking- and family-related problem behavior, involvement with child, time with family, family functioning, relationship quality (child and partner), and harsh treatment of child and partner. Men, partners, and children (ages 8-17) reported on family outcomes.
RESULTS


Eight men completed treatment. Mixed-effects hurdle model analysis showed that alcohol use, both number of days drinking and amount consumed, significantly decreased during and after treatment. Odds of not drinking were 5.1 times higher posttreatment (95% CI [3.3, 7.9]). When men did drink posttreatment, they drank 50% less (95% CI [0.39, 0.65]). Wilcoxon signed-ranks test demonstrated pre-post improvements in depression symptoms and family related outcomes.
CONCLUSION


Results provide preliminary evidence that a BA-MI intervention developed for lay providers may reduce alcohol use and improve family outcomes among men in Kenya. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"When men did drink posttreatment, they drank 50% less (95% CI [0.39, 0.65]).","['Eight men completed treatment', '9 men ages 30 to 48 who were fathers and screened positive for problem drinking; the median Alcohol Use Identification Test score was 17 (harmful range', 'Men, partners, and children (ages 8-17) reported on family outcomes', 'men in Kenya', 'fathers in Kenya']","['alcohol reduction and family engagement intervention', 'BA-MI intervention', '5-session intervention combines behavioral activation (BA) and motivational interviewing (MI']","[""pre-post assessment (1-month) of men's depression symptoms, drinking- and family-related problem behavior, involvement with child, time with family, family functioning, relationship quality (child and partner), and harsh treatment of child and partner"", 'depression symptoms and family related outcomes']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0500725,"When men did drink posttreatment, they drank 50% less (95% CI [0.39, 0.65]).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Giusto', 'Affiliation': 'Department of Psychology and Neuroscience.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Green', 'Affiliation': 'Duke Global Health Institute.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Simmons', 'Affiliation': 'Department of Biostatistics and Bioinformatics.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ayuku', 'Affiliation': 'Department of Behavioural Sciences.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Eve S', 'Initials': 'ES', 'LastName': 'Puffer', 'Affiliation': 'Department of Psychology and Neuroscience.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000559']
2803,33220397,Optimizing Treatment Sequencing of Chemotherapy for Patients with Rectal Cancer: the KIR Randomized Phase II Trial.,"BACKGROUND


Randomized studies have shown low compliance to adjuvant chemotherapy in rectal cancer patients receiving preoperative chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision. We hypothesize that giving neoadjuvant CT before local treatment would improve CT compliance.
METHODS


Between 2010-2017, 180 patients were randomized (2:1) to either Arm A (AA) with FOLFOX x6 cycles prior to high dose rate brachytherapy (HDRBT) and surgery plus adjuvant FOLFOX x6 cycles, or Arm B (AB), with neoadjuvant HDRBT with surgery and adjuvant FOLFOX x12 cycles. The primary endpoint was CT compliance to ≥85% of full-dose CT for the first six cycles. Secondary endpoints were ypT0N0, five-year disease free survival (DFS), local control and overall survival (OS).
RESULTS


Patients were randomized to either AA (n = 120, median age (MA) 62 years) or AB (n = 60, MA 63 years). 175/180 patients completed HDRBT as planned (97.2%). In AA, two patients expired during CT; three patients post-randomization received short course EBRT because of progression under CT (n=2, AA) or personal preference (n=1, AB). ypT0N0 was 31% in AA and 28% in AB (p=0.7). CT Compliance was 80% in AA and 53% in AB (p=0.0002). Acute G3/G4 toxicity was 35.8% in AA and 27.6% in AB (p=0.23). With a median follow-up of 48.5 months (IQR 33-72), the five-year DFS was 72.3% with AA and 68.3% with AB (p = 0.74), the five-year OS 83.8% for AA and 82.2% for AB (p = 0.53), and the five-year local recurrence was 6.3% for AA and 5.8% for AB (p=0.71).
CONCLUSION


We confirmed improved compliance to neoadjuvant CT in this study. Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.
BACKGROUND


In patients with locally advanced rectal cancer, the standard of care consists of preoperative pelvic external beam radiotherapy (EBRT) followed by total mesorectal excision (TME); EBRT either consists of long course chemoradiotherapy (LCRT) with 5-FU/ Capecitabine or short course hypofractionated radiotherapy (SCRT)(1-6). Oxaliplatin in combination with fluoropyrimidine-based chemotherapy (CT) has resulted in improved response rates, progression-free survival (PFS), and overall survival (OS) in metastatic colorectal cancer(7-14) and survival benefit in the adjuvant setting(15, 16). For rectal cancer treatment, adjuvant CT is recommended according to randomized trials including colon and rectal cancers, though there was no strong evidence for the rectal cancer subpopulation. One hypothesis could be related to the low compliance to adjuvant CT in rectal patients after CRT and surgery. Intensification of neoadjuvant CRT failed to demonstrate OS benefit from addition of oxaliplatin to fluoropyrimidine-based CRT, and all(17-20) but the CAOI/ARO/AIO-04 trial(21), reported increased rates of grade 3 and 4 toxicity. Therefore, 5-FU-based CT remains standard with neoadjuvant LCRT and OS unchanged. Thus, the rationale for neoadjuvant CT was introduced to reduce distant metastasis through the early initiation of systemic treatment: better compliance to treatment is expected with this approach, as patients are fitter before TME than in the postoperative phase. At our institution, image-guided high dose rate endorectal brachytherapy (HDRBT)(22, 23) was developed as a highly targeted neoadjuvant radiation (RT) modality for low T2 with close mesorectal fascia (MRF) and T3 rectal cancer. In 678 patients treated with a median follow-up time of 63 months(24), the LR rate was 4.5%, and the five-year overall survival was 71%. In contrast EBRT, HDRBT is given without CT over four consecutive days and allows for lower RT dose to pelvic normal tissue, in particular to bone marrow; additionally, HDRBT offers more targeted RT to the tumor bed than EBRT. Our study was designed to optimize the delivery of systemic CT using HDRBT. More specifically, we sought to explore the value of induction CT in the management of patients with rectal cancer at high risk of systemic recurrence in a randomized multicenter phase II study.
MATERIALS AND METHODS


Study design and participants.",2020,"Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.
","['Patients were randomized to either AA (n\u2009=\u2009120, median age (MA) 62 years) or AB (n\u2009=\u200960, MA 63 years', '180 patients', 'Between 2010-2017', 'Patients with Rectal Cancer', 'Study design and participants', 'rectal cancer patients receiving', 'patients with rectal cancer at high risk of systemic recurrence in a randomized multicenter phase II study', 'patients with locally advanced rectal cancer', 'metastatic colorectal']","['preoperative chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision', 'Chemotherapy', 'oxaliplatin to fluoropyrimidine', 'induction CT', 'adjuvant CT', 'adjuvant chemotherapy', 'FOLFOX x6 cycles prior to high dose rate brachytherapy (HDRBT) and surgery plus adjuvant FOLFOX x6 cycles, or Arm B', 'preoperative pelvic external beam radiotherapy (EBRT) followed by total mesorectal excision (TME); EBRT either consists of long course chemoradiotherapy (LCRT) with 5-FU/ Capecitabine or short course hypofractionated radiotherapy (SCRT)(1-6', '5-FU-based CT', 'fluoropyrimidine-based chemotherapy (CT', 'Oxaliplatin']","['overall survival', 'ypT0N0, five-year disease free survival (DFS), local control and overall survival (OS', 'CT Compliance', 'survival benefit', 'rates of grade 3 and 4 toxicity', 'CT compliance', 'LR rate', 'ypT0N0 rate, local recurrence, and DFS', 'Acute G3/G4 toxicity', 'five-year local recurrence', 'response rates, progression-free survival (PFS), and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",180.0,0.164095,"Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.
","[{'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Garant', 'Affiliation': 'Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'Department of Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'André-Guy', 'Initials': 'AG', 'LastName': 'Martin', 'Affiliation': 'Department of Radiation Oncology, Centre hospitalier universitaire de Québec, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Azoulay', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, and Gerald Bronfman Department of Oncology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vendrely', 'Affiliation': 'Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lavoie', 'Affiliation': 'Department of Radiation Oncology, Centre hospitalier universitaire de Québec, Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Carol-Ann', 'Initials': 'CA', 'LastName': 'Vasilevsky', 'Affiliation': 'Department of Surgery, Division of Colon and Rectal Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, Division of Colon and Rectal Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Faria', 'Affiliation': 'Department of Surgery, Division of General Surgery and Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Trung', 'Initials': 'T', 'LastName': 'Nghia Nguyen', 'Affiliation': 'Department of Hematology, Medical Oncology, Hôpital Charles-LeMoyne, Greenfield Park, QC, Canada.'}, {'ForeName': 'Emery', 'Initials': 'E', 'LastName': 'Ferland', 'Affiliation': 'Department of Hematology, Medical Oncology, Hôpital Pierre-Boucher, Longueuil, QC, Canada.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Des Groseilliers', 'Affiliation': 'Department of Surgery, Hôpital Pierre-Boucher, Longueuil, QC, Canada.'}, {'ForeName': 'Alexis-Simon', 'Initials': 'AS', 'LastName': 'Cloutier', 'Affiliation': 'Department of Surgery, Hôpital Pierre-Boucher, Longueuil, QC, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Diec', 'Affiliation': 'Department of Surgery, Hôpital Pierre-Boucher, Longueuil, QC, Canada.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Drolet', 'Affiliation': ""Department Surgery, Division of Colorectal Surgery, Hôpital Saint-François D'Assise, Quebec City, QC, Canada.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Richard', 'Affiliation': ""Department of Surgery, Division of Colon and Rectal Surgery, Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Batist', 'Affiliation': 'Department of Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Té', 'Initials': 'T', 'LastName': 'Vuon', 'Affiliation': 'Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, QC, Canada. Electronic address: tvuong@jgh.mcgill.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.11.008']
2804,33220426,Strain-Guided Management of Potentially Cardiotoxic Cancer Therapy.,"BACKGROUND


In patients at risk of cancer therapy-related cardiac dysfunction (CTRCD), initiation of cardio-protective therapy (CPT) is constrained by the low sensitivity of EF for minor changes in LV function. Global longitudinal strain (GLS) is a robust and sensitive marker of LV dysfunction, but existing observational data have been insufficient to support a routine GLS-guided strategy for CPT.
OBJECTIVE


To identify whether GLS-guided CPT prevents reduction in LVEF in patients undergoing potentially cardiotoxic chemotherapy, compared with usual care.
METHODS


In this international multicenter prospective randomized controlled trial, 331 anthracycline-treated patients with another heart failure risk factor were randomly allocated to CPT initiation guided by either ≥12% relative reduction in GLS (n=166) or >10% absolute reduction of LVEF (n=165). Patients were followed for EF and development of CTRCD (symptomatic EF reduction >5% or >10% asymptomatic to <55%) over 1 year.
RESULTS


Of 331 randomized patients, 2 died and 22 withdrew consent or were lost to follow-up. Among 307 patients (age 54±12 years, 94% women, baseline LVEF 59±6%, GLS -20.6±2.4%) with a median (IQR) follow-up of 1.02 (0.98-1.07) years, most (n=278) had breast cancer. HF risk factors were prevalent: 29% had hypertension and 13% had diabetes mellitus. At 1-year follow-up, although the primary outcome of change in LVEF was not significantly different between the two arms, there was significantly greater use of CPT, and fewer patients met CTRCD criteria in the GLS-guided than the EF-guided arm (5.8% vs 13.7%, p=0.02), and 1-year EF was 57±6% versus 55±7% (p=0.05). Patients diagnosed with CTRCD in the EF-guided arm had a larger reduction in LVEF at follow-up than in the GLS-guided arm (9.1±10.9% versus 2.9±7.4%, p=0.03).
CONCLUSIONS


Although the change in LVEF was not different between the two arms, GLS-guided CPT significantly reduced a meaningful fall of LVEF to the abnormal range. The results support the use of GLS in surveillance for CTRCD.",2020,"Although the change in LVEF was not different between the two arms, GLS-guided CPT significantly reduced a meaningful fall of LVEF to the abnormal range.","['307 patients (age 54±12 years, 94% women, baseline LVEF 59±6%, GLS -20.6±2.4%) with a median (IQR) follow-up of 1.02 (0.98-1.07) years, most (n=278) had breast cancer', 'patients at risk of cancer therapy-related cardiac dysfunction (CTRCD), initiation of cardio-protective therapy (CPT', '331 anthracycline-treated patients with another heart failure risk factor', 'patients undergoing potentially cardiotoxic chemotherapy, compared with usual care']","['Strain-Guided Management of Potentially Cardiotoxic Cancer Therapy', 'CPT', 'GLS-guided CPT', 'LVEF', 'CPT initiation guided by either ≥12% relative reduction in GLS', 'Global longitudinal strain (GLS']","['HF risk factors', 'EF and development of CTRCD (symptomatic EF reduction', 'diabetes mellitus', 'LVEF', 'change in LVEF', '1-year EF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439234', 'cui_str': 'year'}]",331.0,0.060819,"Although the change in LVEF was not different between the two arms, GLS-guided CPT significantly reduced a meaningful fall of LVEF to the abnormal range.","[{'ForeName': 'Paaladinesh', 'Initials': 'P', 'LastName': 'Thavendiranathan', 'Affiliation': 'Ted Rogers Program in Cardiotoxicity Prevention, Peter Munk Cardiac Center, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Negishi', 'Affiliation': 'Menzies Research Institute, Hobart, Australia; Sydney Medical School Nepean, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Somerset', 'Affiliation': 'Rogers Computational Program, Ted Rogers Centre for Heart Research, Peter Munk Cardiac Centre, University Health Network.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Negishi', 'Affiliation': 'Menzies Research Institute, Hobart, Australia; Sydney Medical School Nepean, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Penicka', 'Affiliation': 'Cardiovascular Research Center Aalst, Aalst, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'Centre Hospitalier Universitaire (CHU) -de Québec-Université Laval, Quebec, Canada.'}, {'ForeName': 'Svend', 'Initials': 'S', 'LastName': 'Aakhus', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Miyazaki', 'Affiliation': 'Juntendo University Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Shirazi', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Galderisi', 'Affiliation': 'Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Marwick', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia. Electronic address: Tom.Marwick@bakeridi.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.11.020']
2805,33220462,"Safety, Tolerability and Pharmacokinetics of Bencycloquidium Bromide, a Novel Inhaled Anticholinergic Bronchodilator, in Healthy Subjects: Results from Phase I Studies.","BACKGROUND


Bencycloquidium bromide (BCQB) is a novel inhaled anticholinergic bronchodilator with high selectivity for muscarinic M3 receptor. BCQB's potential utility of for therapy in Chronic obstructive pulmonary disease (COPD) has been indicated in pre-clinical studies.
PURPOSE


To investigate the initial safety, tolerability and pharmacokinetics of BCQB delivered via pressurised Metered Dose Inhaler (pMDI) in healthy subjects.
METHODS


This study consisted of single-ascending-dose (SAD), multiple-ascending-dose (MAD) tolerability study periods, and single- plus multiple-dose pharmacokinetic study periods. Randomized, double-blind, placebo-controlled, dose-escalating tolerability and pharmacokinetic studies were conducted. Seventy-two healthy subjects were assigned 3:1 (BCQB: placebo) to 7 single-dose cohorts (125, 250, 500, 750, 1125, 1500 and 2000 μg) and 2 multiple-dose cohorts (1500 μg/d and 2000 μg/d). In the pharmacokinetic periods, 12 subjects were allocated three-way crossover to receive single dose of 250, 750 or 2000 μg BCQB, respectively. Subsequently, the same 12 subjects received multiple dose of 750 μg/d and 1000 μg/d for 7 days. Pharmacokinetic, safety and tolerability assessments were performed.
RESULTS


BCQB administered by inhalation was well tolerated, especially with favorable cardiovascular safety profile. BCQB was rapidly absorbed into plasma after inhalation through pMDI, with peak concentrations achieved within 5 to 10 minutes. Repeated inhalation caused certain degree of accumulation with the accumulation ratio R Cmax  2.50, R AUC  3.49 for 3 times-a-day and R Cmax  2.23, R AUC  3.44 for 4 times-a-day, respectively. Twice-a-day or even once-a-day dosage could be suggested in phase II study. Sex didn't affect the pharmacokinetics of BCQB and dose adjustments based on sex is not anticipated in clinical use. Approximately 4% of the BCQB dose excreted unchanged in urine and liver metabolism is the main biotransformation route of BCQB in human.
CONCLUSIONS


The results of our study provided the initial safety, tolerability and pharmacokinetic profiles of BCQB inhalation, and could enable further clinical development in COPD patients.",2020,"Repeated inhalation caused certain degree of accumulation with the accumulation ratio R Cmax  2.50, R AUC  3.49 for 3 times-a-day and R Cmax  2.23, R AUC  3.44 for 4 times-a-day, respectively.","['Chronic obstructive pulmonary disease (COPD', 'healthy subjects', 'Seventy-two healthy subjects were assigned 3:1', '7 single-dose cohorts (125, 250, 500, 750, 1125, 1500 and 2000 μg) and 2 multiple-dose cohorts (1500 μg/d and 2000 μg/d', 'Healthy Subjects', 'COPD patients', '12 subjects']","['Bencycloquidium bromide ', 'placebo', 'BCQB delivered via pressurised Metered Dose Inhaler (pMDI', 'BCQB', 'Bencycloquidium Bromide', 'BCQB: placebo']","['initial safety, tolerability and pharmacokinetics', 'Pharmacokinetic, safety and tolerability assessments', 'Safety, Tolerability and Pharmacokinetics', 'BCQB', 'accumulation ratio R Cmax']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1870334', 'cui_str': 'bencycloquidium bromide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",72.0,0.143896,"Repeated inhalation caused certain degree of accumulation with the accumulation ratio R Cmax  2.50, R AUC  3.49 for 3 times-a-day and R Cmax  2.23, R AUC  3.44 for 4 times-a-day, respectively.","[{'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Pharmaceutical Research Institute, Yingu Pharmaceutical Co. Ltd., Beijing, 100190, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.. Electronic address: dingli@cpu.edu.cn.'}, {'ForeName': 'Maozhi', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'GCP Center / Institute of Drug Clinical Trials, West China Hospital, Sichuan University, Chengdu 610041, China;. Electronic address: tayler22@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105646']
2806,33220488,Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model.,"BACKGROUND


The treatment of suicidal patients often suffers owing to a lack of integrated care and standardized approaches for identifying and reducing risk. The National Strategy for Suicide Prevention endorsed the Zero Suicide (ZS) model, a multi-component, system-wide approach to identify, engage and treat suicidal patients. The ZS model is a framework for suicide prevention in healthcare systems with the aspirational goal of eliminating suicide in healthcare. While the approach is widely endorsed, it has yet to be evaluated in a systematic manner. This trial evaluates two ZS implementation strategies statewide in specialty mental health clinics.
METHODS/STUDY DESIGN


This trial is the first large-scale implementation of the ZS model in mental health clinics using the Assess, Intervene, and Monitor for Suicide Prevention (A-I-M) clinical model. Using a hybrid effectiveness-implementation type 1 design, we are testing the effectiveness of ZS implementation in 186 mental health clinics in 95 agencies in New York State. Agencies are randomly assigned to either: ""Basic Implementation"" (BI; a large group didactic learning collaboratives) or ""Enhanced Implementation"" (EI; participatory small group learning collaboratives; enhanced consultation for site champions). Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
DISCUSSION


This project has the potential to have a significant public health impact by determining the effectiveness of the ZS model in mental health clinics, a setting where suicide attempts and suicides occur at a higher rate than any other healthcare setting. It will also provide guidance on the implementation level required to achieve uptake and sustainability of ZS.
TRIAL REGISTRATION


N/A.",2020,"Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
","['186 mental health clinics in 95 agencies in New York State', 'suicidal patients', 'specialty mental health clinics']","['Basic Implementation"" (BI; a large group didactic learning collaboratives) or ""Enhanced Implementation"" (EI; participatory small group learning collaboratives', 'ZS implementation']","['suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation']","[{'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",186.0,0.0632626,"Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA. Electronic address: bhs2@cumc.columbia.edu.'}, {'ForeName': 'Christa D', 'Initials': 'CD', 'LastName': 'Labouliere', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA.'}, {'ForeName': 'Anga C', 'Initials': 'AC', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Molly T', 'Initials': 'MT', 'LastName': 'Finnerty', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Prabu', 'Initials': 'P', 'LastName': 'Vasan', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Anni Kramer', 'Initials': 'AK', 'LastName': 'Cummings', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Wainberg', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Carruthers', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Dixon', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106224']
2807,32691848,"The Promise, and Challenges, of Methods to Enhance the External Validity of Randomized Trial Results.",,2020,"Results from randomized trials do not necessarily apply to clinical practice, particularly if the trial sample and target population differ on factors that modify treatment effects.",[],[],[],[],[],[],,0.132061,"Results from randomized trials do not necessarily apply to clinical practice, particularly if the trial sample and target population differ on factors that modify treatment effects.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stuart', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Lesko', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1992']
2808,32687474,Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial.,"BACKGROUND


Though maintaining physical conditioning and a healthy weight are requirements of active military duty, many US veterans lose conditioning and rapidly gain weight after discharge from active duty service. Mobile health (mHealth) interventions using wearable devices are appealing to users and can be effective especially with personalized coaching support. We developed Stay Strong, a mobile app tailored to US veterans, to promote physical activity using a wrist-worn physical activity tracker, a Bluetooth-enabled scale, and an app-based dashboard. We tested whether adding personalized coaching components (Stay Strong+Coaching) would improve physical activity compared to Stay Strong alone.
OBJECTIVE


The goal of this study is to compare 12-month outcomes from Stay Strong alone versus Stay Strong+Coaching.
METHODS


Participants (n=357) were recruited from a national random sample of US veterans of recent wars and randomly assigned to the Stay Strong app alone (n=179) or Stay Strong+Coaching (n=178); both programs lasted 12 months. Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3 per week), telephone-based human health coaching (up to 3 calls), and personalized weekly goal setting. All aspects of the enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching. The primary outcome was change in physical activity at 12 months postbaseline, measured by average weekly Active Minutes, captured by the Fitbit Charge 2 device. Secondary outcomes included changes in step counts, weight, and patient activation.
RESULTS


The average age of participants was 39.8 (SD 8.7) years, and 25.2% (90/357) were female. Active Minutes decreased from baseline to 12 months for both groups (P<.001) with no between-group differences at 6 months (P=.82) or 12 months (P=.98). However, at 12 months, many participants in both groups did not record Active Minutes, leading to missing data in 67.0% (120/179) for Stay Strong and 61.8% (110/178) for Stay Strong+Coaching. Average baseline weight for participants in Stay Strong and Stay Strong+Coaching was 214 lbs and 198 lbs, respectively, with no difference at baseline (P=.54) or at 6 months (P=.28) or 12 months (P=.18) postbaseline based on administrative weights, which had lower rates of missing data. Changes in the number of steps recorded and patient activation also did not differ by arm.
CONCLUSIONS


Adding personalized health coaching comprised of in-app automated messages, up to 3 coaching calls, plus automated weekly personalized goals, did not improve levels of physical activity compared to using a smartphone app alone. Physical activity in both groups decreased over time. Sustaining long-term adherence and engagement in this mHealth intervention proved difficult; approximately two-thirds of the trial's 357 participants failed to sync their Fitbit device at 12 months and, thus, were lost to follow-up.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/12526.",2020,"All aspects of enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching.","['Veterans', 'Participants (n=357) were recruited from a national random sample of U.S. Veterans of recent wars and randomly assigned to', 'Average age of participants was 39.8 (8.7) years and 25.2% were female']","['Stay Strong alone versus Stay Strong+Coaching', 'Personalized coaching components for Stay Strong+Coaching comprised of automated in-app motivational messages (3/week), telephone-based human health coaching', 'Personalized health coaching', 'personalized coaching components (Stay Strong+Coaching', 'Telephone-based Brief Coaching to a mHealth App', 'Stay Strong app alone (n=179) or Stay Strong+Coaching', 'Mobile health (mHealth) interventions']","['number of steps recorded and patient activation', 'changes in step counts, weight, and patient activation', 'change in physical activity', 'Physical activity', 'Average baseline weight', 'Physical Activity', 'physical activity', 'levels of physical activity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",357.0,0.0813274,"All aspects of enrollment process and program delivery were accomplished virtually for both groups, except for the telephone-based coaching.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Damschroder', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor Healthcare System, Ann Arbor, MI, United States.'}, {'ForeName': 'Lorraine R', 'Initials': 'LR', 'LastName': 'Buis', 'Affiliation': 'University of Michigan, Department of Family Medicine, Ann Arbor, MI, United States.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'McCant', 'Affiliation': 'Veterans Affairs Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States.'}, {'ForeName': 'Hyungjin Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor Healthcare System, Ann Arbor, MI, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor Healthcare System, Ann Arbor, MI, United States.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Veterans Affairs Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Bastian', 'Affiliation': 'Veterans Affairs Pain Research, Informatics, Multimorbidities, and Education Center, Veterans Affairs Connecticut, West Haven, CT, United States.'}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Hooks', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Ann Arbor Healthcare System, Ann Arbor, MI, United States.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Kadri', 'Affiliation': 'University of Michigan, Department of Family Medicine, Ann Arbor, MI, United States.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'White-Clark', 'Affiliation': 'Veterans Affairs Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'University of Michigan, Department of Family Medicine, Ann Arbor, MI, United States.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gierisch', 'Affiliation': 'Veterans Affairs Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care System, Durham, NC, United States.'}]",Journal of medical Internet research,['10.2196/19216']
2809,32696102,The role of ozonized oil and a combination of tobramycin/dexamethasone eye drops in the treatment of viral conjunctivitis: a randomized clinical trial.,"PURPOSE


To determine whether topical tobramycin 0.3%/dexamethasone 0.1% plus ozonized oil eye drops reduces clinical signs and infectious viral titers of presumed viral conjunctivitis more than tobramycin/dexamethasone eye drops alone.
METHODS


Prospective, single-blind, randomized, parallel-groups trial. Eighty patients with a clinical diagnosis of presumed viral conjunctivitis were randomizedly divided into two treatment groups: a study group and a control group, 40 for each group. Patients in the study group received topical tobramycin 0.3%/dexamethasone 0.1% eye drops, plus ozonized oil eye drops, both four times daily; patients in the control group received only topical tobramycin 0.3%/dexamethasone eye drops four times daily. The treatment was for seven days in both groups. Swabs were taken from the conjunctival fornix for adenovirus PCR analysis on the day of recruitment and at seven days follow-up. Clinical signs were also recorded on the day of recruitment and at follow-up examination: the main outcomes were conjunctival injection and conjunctival chemosis, graded on a 4-point clinical scale, presence or absence of superficial punctate keratitis and subepithelial corneal infiltrates.
RESULTS


No statistically significant difference was reached in adenoviral infection negativization between the two groups, although the study group showed a higher number of PCR negative results at seven days follow-up. PCR real time detected adenoviral infection in 17 of 24 patients on the day of recruitment and it was positive in 4 patients on the seventh day (viral positivity reduction of 76%). In the control group PCR was positive for adenovirus in 18 of 24 patients on the day of recruitment and in 7 patients at seven days follow-up (reduction of 61%). There was statistically significant difference on conjunctival clinical signs between the study and control groups. Significant difference was also found on superficial punctate keratitis resolution between the study and the control group. In the former superficial punctate keratitis was detected in 14 eyes on the first day and in 5 eyes after seven days while in the latter superficial punctate keratitis was found in 124 eyes on the first day and in 6 eyes on the seventh day. No difference was found in subepithelial corneal infiltrates appearance between the two groups.
CONCLUSIONS


The use of ozonized-oil containing eye drops in combination with topical tobramycin 0.3%/dexamethasone 0.1% eye drops four times daily seems to reduce the signs of conjunctivitis, and the duration of viral infection, although it does not affect the subepithelial corneal infiltrates appearance.",2020,"No statistically significant difference was reached in adenoviral infection negativization between the two groups, although the study group showed a higher number of PCR negative results at seven days follow-up.","['viral conjunctivitis', 'Eighty patients with a clinical diagnosis of presumed viral conjunctivitis']","['topical tobramycin 0.3%/dexamethasone 0.1% eye drops, plus ozonized oil eye drops', 'topical tobramycin 0.3%/dexamethasone', 'topical tobramycin 0.3%/dexamethasone 0.1% plus ozonized oil eye drops', 'tobramycin/dexamethasone', 'ozonized oil and a combination of tobramycin/dexamethasone eye drops', 'topical tobramycin 0.3%/dexamethasone eye drops four times daily']","['conjunctival injection and conjunctival chemosis, graded on a 4-point clinical scale, presence or absence of superficial punctate keratitis and subepithelial corneal infiltrates', 'PCR real time detected adenoviral infection', 'adenoviral infection negativization', 'signs of conjunctivitis, and the duration of viral infection', 'subepithelial corneal infiltrates appearance', 'clinical signs and infectious viral titers of presumed viral conjunctivitis', 'PCR negative results', 'conjunctival clinical signs', 'superficial punctate keratitis resolution']","[{'cui': 'C0009774', 'cui_str': 'Viral conjunctivitis'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0304706', 'cui_str': 'Dexamethasone-containing product in ocular dose form'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}]","[{'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0271298', 'cui_str': 'Chemosis of conjunctiva'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0259799', 'cui_str': 'Superficial punctate keratitis'}, {'cui': 'C0853336', 'cui_str': 'Infiltrate of cornea'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0851887', 'cui_str': 'Adenoviral infections'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2748213', 'cui_str': 'Viral titre'}, {'cui': 'C0009774', 'cui_str': 'Viral conjunctivitis'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}]",80.0,0.0466561,"No statistically significant difference was reached in adenoviral infection negativization between the two groups, although the study group showed a higher number of PCR negative results at seven days follow-up.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cagini', 'Affiliation': 'Division of Ophthalmology, Department of Surgical and Biomedical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, 06156, Perugia, Italy. carlo.cagini@unipg.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mariniello', 'Affiliation': 'Division of Ophthalmology, Department of Surgical and Biomedical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, 06156, Perugia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Messina', 'Affiliation': 'Division of Ophthalmology, Department of Surgical and Biomedical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, 06156, Perugia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Muzi', 'Affiliation': 'Division of Ophthalmology, Department of Surgical and Biomedical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, 06156, Perugia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Balducci', 'Affiliation': 'Division of Ophthalmology, Department of Surgical and Biomedical Sciences, University of Perugia, Ospedale S. Maria della Misericordia, S. Andrea Delle Fratte, 06156, Perugia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moretti', 'Affiliation': 'Microbiology Unit, Department of Medicine, University of Perugia, Ospedale S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Levorato', 'Affiliation': 'Microbiology Unit, Department of Medicine, University of Perugia, Ospedale S. Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mencacci', 'Affiliation': 'Microbiology Unit, Department of Medicine, University of Perugia, Ospedale S. Maria della Misericordia, Perugia, Italy.'}]",International ophthalmology,['10.1007/s10792-020-01503-4']
2810,32692952,Posterior Rotational and Translational Stability in Acromioclavicular Ligament Complex Reconstruction: A Comparative Biomechanical Analysis in Cadaveric Specimens.,"BACKGROUND


Persistent posterior instability of the acromioclavicular (AC) joint is a reported complication after isolated coracoclavicular (CC) reconstruction. Thus, multiple techniques have been proposed attempting to restore biomechanics of the AC ligament complex (ACLC).
PURPOSE/HYPOTHESIS


The purpose was to evaluate the posterior translational and rotational stability of an ACLC reconstruction with a dermal allograft (ACLC patch) as compared with 3 suture brace constructs. It was hypothesized that the ACLC patch would better restore AC joint posterior stability.
STUDY DESIGN


Controlled laboratory study.
METHODS


A total of 28 cadaveric shoulders (mean ± SD age, 57.6 ± 8.3 years) were randomly assigned to 1 of 4 surgical techniques: ACLC patch, oblique brace, anterior brace, and x-frame brace. The force and torque to achieve 10 mm of posterior translation and 20° of posterior rotation of the AC joint were recorded in the following conditions: intact, transected ACLC, ACLC patch/brace repair, ACLC patch/brace repair with dissected CC ligaments, and ACLC patch/brace repair with CC ligament repair.
RESULTS


For posterior translation, transection of the ACLC reduced resistance to 16.7% of the native. With the native CC ligaments intact, the ACLC patch (59.1%), oblique brace (54.1%), and anterior brace (60.7%) provided significantly greater stability than the x-frame brace (33.2%;  P  < .001,  P  = .008,  P  < .001, respectively). ACLC patch, oblique brace, and anterior brace continued to have significantly higher posterior translational resistance than the x-frame (35.1%;  P  < .001,  P  = .003,  P  < .001) after transection and subsequent CC ligament repair. For posterior rotation, transection of the ACLC decreased the resistance to 5.4% of the intact state. With the CC ligaments intact, the ACLC patch (77.1%) better restored posterior rotational stability than the oblique (35.3%), anterior (48.5%), and x-frame (23.0%) brace repairs ( P  < .001,  P  = .002,  P  < .001). CC ligament transection and subsequent repair demonstrated the ACLC patch (41.0%) to have improved stability when compared with the oblique (16.0%), anterior (14.0%), and x-frame (12.7%) repairs ( P  = .006,  P  = .003,  P  = .002).
CONCLUSION


ACLC reconstruction with a dermal allograft better restored native posterior rotational stability than other brace constructs, with translational stability similar to the oblique and anterior brace technique at the time of surgery.
CLINICAL RELEVANCE


Horizontal stability of the AC joint is primarily controlled by the ACLC. Inability to restore AC joint biomechanics can result in persistent posterior instability and lead to functional impairment.",2020,"With the CC ligaments intact, the ACLC patch (77.1%) better restored posterior rotational stability than the oblique (35.3%), anterior (48.5%), and x-frame (23.0%) brace repairs ( P  < .001,  P  = .002,  P  < .001).","['Cadaveric Specimens', 'Acromioclavicular Ligament Complex Reconstruction', '28 cadaveric shoulders (mean ± SD age, 57.6 ± 8.3 years']","['ACLC reconstruction with a dermal allograft (ACLC patch', '4 surgical techniques: ACLC patch, oblique brace, anterior brace, and x-frame brace', 'ACLC patch', 'intact, transected ACLC, ACLC patch/brace repair, ACLC patch/brace repair with dissected CC ligaments, and ACLC patch/brace repair with CC ligament repair']","['posterior translational and rotational stability', 'restore AC joint posterior stability', 'anterior brace', 'oblique brace', 'posterior rotational stability', 'posterior translational resistance']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0225039', 'cui_str': 'Structure of acromioclavicular ligament'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0225040', 'cui_str': 'Coracoclavicular ligament structure'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001208', 'cui_str': 'Acromioclavicular joint structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",28.0,0.0329299,"With the CC ligaments intact, the ACLC patch (77.1%) better restored posterior rotational stability than the oblique (35.3%), anterior (48.5%), and x-frame (23.0%) brace repairs ( P  < .001,  P  = .002,  P  < .001).","[{'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Morikawa', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Joel B', 'Initials': 'JB', 'LastName': 'Huleatt', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Lukas N', 'Initials': 'LN', 'LastName': 'Muench', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Kia', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Berthold', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Elifho', 'Initials': 'E', 'LastName': 'Obopilwe', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Kelolli', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Scheiderer', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Augustus D', 'Initials': 'AD', 'LastName': 'Mazzocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}]",The American journal of sports medicine,['10.1177/0363546520939882']
2811,32694058,Mid-Term Outcomes After Treatment for Antibody-Mediated Rejection by De Novo Donor-Specific HLA Antibody in Renal Transplant Recipients: Does Early Treatment Lead to Better Outcomes?,"BACKGROUND


De novo donor-specific HLA antibody (DSA) and antibody-mediated rejection (ABMR) are strongly associated with late allograft loss in renal transplant recipients. However, the impact of therapeutic intervention with the current treatment options for ABMR remains unclear. This study aimed to elucidate the efficacy of treatment for ABMR.
METHODS


Sixty-seven patients who had de novo DSAs underwent diagnostic biopsy for ABMR, and these patients were classified into 3 groups: ABMR-free group (n = 40), clinical ABMR group (n = 15), and subclinical ABMR group (n = 12). The ABMR-positive groups were treated mainly with double-filtration plasmapheresis followed by rituximab and corticosteroid pulse. The patient characteristics and graft outcomes were compared between groups.
RESULTS


The clinical and subclinical ABMR groups were younger and had a higher number and mean fluorescence intensity (MFI) of de novo DSAs than the ABMR-free group. The graft survival in the clinical ABMR group was significantly lower than that in the ABMR-free group, but the subclinical ABMR group had a surprisingly good graft survival rate compared to the ABMR-free group (43.3% vs 100% vs 94.2% 5 years after diagnostic biopsy in the clinical ABMR, subclinical ABMR, and ABMR-free groups, respectively, P < .001).
CONCLUSIONS


Our findings indicated that early therapeutic intervention for patients with de novo DSAs may improve graft survival.",2020,"The graft survival in the clinical ABMR group was significantly lower than that in the ABMR-free group, but the subclinical ABMR group had a surprisingly good graft survival rate compared to the ABMR-free group (43.3% vs 100% vs 94.2% 5 years after diagnostic biopsy in the clinical ABMR, subclinical ABMR, and ABMR-free groups, respectively, P < .001).
","['Sixty-seven patients who had de novo DSAs underwent diagnostic biopsy for ABMR, and these patients were classified into 3 groups: ABMR-free group (n\xa0= 40), clinical ABMR group (n\xa0= 15), and subclinical ABMR group (n\xa0= 12', 'Renal Transplant Recipients', 'renal transplant recipients']",['rituximab and corticosteroid pulse'],"['graft survival', 'mean fluorescence intensity (MFI) of de novo DSAs', 'graft survival rate']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",67.0,0.0202951,"The graft survival in the clinical ABMR group was significantly lower than that in the ABMR-free group, but the subclinical ABMR group had a surprisingly good graft survival rate compared to the ABMR-free group (43.3% vs 100% vs 94.2% 5 years after diagnostic biopsy in the clinical ABMR, subclinical ABMR, and ABMR-free groups, respectively, P < .001).
","[{'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan. Electronic address: ubanam@nagoya2.jrc.or.jp.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Tomosugi', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Futamura', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hiramitsu', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Goto', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Narumi', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Takeda', 'Affiliation': 'Department of Nephrology, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant and Endocrine Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.06.022']
2812,32700955,A randomized controlled trial of central executive training (CET) versus inhibitory control training (ICT) for ADHD.,"OBJECTIVE


Executive function deficits are well-established in ADHD. Unfortunately, replicated evidence indicates that executive function training for ADHD has been largely unsuccessful. We hypothesized that this may reflect insufficient targeting, such that extant protocols do not sufficiently and specifically target the neurocognitive systems associated with phenotypic ADHD behaviors/impairments.
METHOD


Children with ADHD ages 8-12 (M = 10.41, SD = 1.46; 12 girls; 74% Caucasian/Non-Hispanic) were randomized with allocation concealment to either central executive training (CET; n = 25) or newly developed inhibitory control training (ICT; n = 29). Detailed data analytic plans were preregistered.
RESULTS


Both treatments were feasible/acceptable based on training duration, child-reported ease of use, and parent-reported high satisfaction. CET was superior to ICT for improving its primary intervention targets: phonological and visuospatial working memory (d = 0.70-0.84). CET was also superior to ICT for improving go/no-go (d = 0.84) but not stop-signal inhibition. Mechanisms of change analyses indicated that CET-related working memory improvements produced significant reductions in the primary clinical endpoints (objectively assessed hyperactivity) during working memory and inhibition testing (indirect effects: β ≥ -.11; 95% CIs exclude 0.0). CET was also superior to ICT on 3 of 4 secondary clinical endpoints (blinded teacher-rated ADHD symptoms; d = 0.46-0.70 vs. 0.16-0.42) and 2 of 4 feasibility/acceptability clinical endpoints (parent-reported ADHD symptoms; d = 0.96-1.42 vs. 0.45-0.65). CET-related gains were maintained at 2-4 month follow-up; ICT-related gains were maintained for attention problems but not hyperactivity/impulsivity per parent report.
CONCLUSIONS


Results support the use of CET for treating executive function deficits and targeting ADHD behavioral symptoms in children with ADHD. Findings for ICT were mixed at best and indicate the need for continued development/study. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"CET-related gains were maintained at 2-4 month follow-up; ICT-related gains were maintained for attention problems but not hyperactivity/impulsivity per parent report.
","['children with ADHD', 'Children with ADHD ages 8-12 (M = 10.41, SD = 1.46; 12 girls; 74% Caucasian/Non-Hispanic']","['central executive training (CET; n = 25) or newly developed inhibitory control training (ICT', 'central executive training (CET) versus inhibitory control training (ICT', 'ICT', 'CET']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191363', 'cui_str': '1.46'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.087537,"CET-related gains were maintained at 2-4 month follow-up; ICT-related gains were maintained for attention problems but not hyperactivity/impulsivity per parent report.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kofler', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Wells', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Leah J', 'Initials': 'LJ', 'LastName': 'Singh', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Elia F', 'Initials': 'EF', 'LastName': 'Soto', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Irwin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Groves', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Elizabeth S M', 'Initials': 'ESM', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Miller', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kijana P', 'Initials': 'KP', 'LastName': 'Richmond', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Schatschneider', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lonigan', 'Affiliation': 'Department of Psychology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000550']
2813,32700956,Applying experimental therapeutics to examine cognitive and chronological vulnerabilities as mediators of acute outcomes in cognitive-behavioral therapy and light therapy for winter depression.,"OBJECTIVE


We applied the experimental therapeutics approach to test whether acute treatment outcomes for winter seasonal affective disorder (SAD) are mediated by a cognitive mechanism in cognitive-behavioral therapy (CBT-SAD) versus a chronobiologic mechanism in light therapy (LT).
METHOD


Currently depressed adults with major depression, recurrent with seasonal pattern (N = 177; 83.6% female, 92.1% non-Hispanic White, M age = 45.6) were randomized to 6 weeks of LT or group CBT-SAD. SAD symptoms were assessed weekly on the Structured Clinical Interview for the Hamilton Rating Scale for Depression-SAD Version. At pre-, mid-, and posttreatment, participants completed measures of general depressogenic cognitions (Dysfunctional Attitudes Scale; DAS); SAD-specific negative cognitions (Seasonal Beliefs Questionnaire; SBQ); chronotype (Morningness-Eveningness Questionnaire; MEQ); and depressive symptoms (Beck Depression Inventory-Second Edition).
RESULTS


Parallel-process growth models showed evidence for hypothesized mechanisms. For SAD-specific negative cognitions (SBQ), both symptom measures showed (1) an effect of treatment group on the slope of the mediator, with CBT-SAD demonstrating greater decreases, and (2) an effect of the slope of the mediator on the slope of the outcome. These effects held for the SBQ but not the broader measure of depressogenic cognitions (DAS). For the chronotype measure (MEQ), treatment assignment affected change, whereby LT was associated with reduced ""eveningness,"" but this was unrelated to change in symptoms.
CONCLUSIONS


CBT-SAD promoted decreases in SAD-specific negative cognitions, and these changes were related to decreases in symptoms. Consistent with the theory that LT corrects misaligned circadian rhythms, LT reduced eveningness, but this did not correspond to symptom improvement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"For the chronotype measure (MEQ), treatment assignment affected change, whereby LT was associated with reduced ""eveningness,"" but this was unrelated to change in symptoms.
","['winter depression', 'Currently depressed adults with major depression, recurrent with seasonal pattern (N = 177; 83.6% female, 92.1% non-Hispanic White, M age = 45.6', 'winter seasonal affective disorder (SAD']","['cognitive-behavioral therapy (CBT-SAD', 'cognitive-behavioral therapy and light therapy', 'CBT-SAD', 'LT or group CBT-SAD']","['general depressogenic cognitions (Dysfunctional Attitudes Scale; DAS); SAD-specific negative cognitions (Seasonal Beliefs Questionnaire; SBQ); chronotype (Morningness-Eveningness Questionnaire; MEQ); and depressive symptoms (Beck Depression Inventory-Second Edition', 'depressogenic cognitions (DAS', 'SAD symptoms', 'SAD-specific negative cognitions', 'Structured Clinical Interview for the Hamilton Rating Scale for Depression-SAD Version', 'For SAD-specific negative cognitions (SBQ']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0343493,"For the chronotype measure (MEQ), treatment assignment affected change, whereby LT was associated with reduced ""eveningness,"" but this was unrelated to change in symptoms.
","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Rohan', 'Affiliation': 'Department of Psychological Science.'}, {'ForeName': 'Keith B', 'Initials': 'KB', 'LastName': 'Burt', 'Affiliation': 'Department of Psychological Science.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Camuso', 'Affiliation': 'Department of Psychological Science.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Department of Psychological Science.'}, {'ForeName': 'Jonah', 'Initials': 'J', 'LastName': 'Meyerhoff', 'Affiliation': 'Department of Psychological Science.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000499']
2814,32691228,"The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after cesarean section with vertical incision: a randomized, double-blinded placebo-controlled study.","PURPOSE


Quadratus lumborum block (QLB) has recently been used for postoperative analgesia after abdominal surgery. Although there are several approaches to QLB, the effectiveness of intramuscular QLB (QLBi) remains controversial. The aim of the present study was to examine the effectiveness of QLBi for postoperative analgesia after cesarean section with a vertical midline incision.
METHODS


In this single-center, randomized, double-blinded placebo-controlled study, 36 women who were scheduled for elective cesarean section were randomly divided into a QLBi group (n = 18) and a placebo group (n = 18). In both groups, spinal anesthesia was performed with 10-11 mg hyperbaric bupivacaine and 15 µg fentanyl. After the surgery, in the QLBi group, 0.4 mL/kg of 0.25% ropivacaine was injected into the bilateral quadratus lumborum muscle under ultrasound guidance (the total volume was 0.8 mL/kg). In the placebo group, instead of ropivacaine, the subjects were injected with the same amount of normal saline. The primary outcome measure was elapsed time to first analgesic use from the QLBi block after cesarean section.
RESULTS


The data from all 36 patients were analyzed. There were no significant differences between the QLBi and placebo groups regarding elapsed time to first postoperative analgesic use [mean 230 (standard deviation 103) vs 194 (89) min; 95% confidence interval - 101 to 30; p = 0.27].
CONCLUSIONS


QLBi with the concentration and amount of local anesthetic used in the present study was clinically slightly effective, and the effect was limited for postoperative analgesia after cesarean section.",2020,"There were no significant differences between the QLBi and placebo groups regarding elapsed time to first postoperative analgesic use [mean 230 (standard deviation 103) vs 194 (89) min; 95% confidence interval - 101 to 30; p = 0.27].
","['postoperative analgesia after cesarean section with vertical incision', '36 women who were scheduled for elective cesarean section']","['normal saline', 'Quadratus lumborum block (QLB', 'placebo', 'intramuscular quadratus lumborum block', 'ropivacaine', 'hyperbaric bupivacaine', 'QLBi']","['elapsed time to first analgesic use from the QLBi block after cesarean section', 'elapsed time to first postoperative analgesic use']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",36.0,0.511965,"There were no significant differences between the QLBi and placebo groups regarding elapsed time to first postoperative analgesic use [mean 230 (standard deviation 103) vs 194 (89) min; 95% confidence interval - 101 to 30; p = 0.27].
","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Anesthesiology, Aidu Chuo Hospital, 1-1, Tsuruga-machi, Aizuwakmatsu, Fukushima, 965-8611, Japan. kei-y7of@fmu.ac.jp.'}, {'ForeName': 'Shiori', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesiology, Aidu Chuo Hospital, 1-1, Tsuruga-machi, Aizuwakmatsu, Fukushima, 965-8611, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Aidu Chuo Hospital, 1-1, Tsuruga-machi, Aizuwakmatsu, Fukushima, 965-8611, Japan.'}, {'ForeName': 'Shinju', 'Initials': 'S', 'LastName': 'Obara', 'Affiliation': 'Department of Anesthesiology, Fukushima Medical University, 1, Hikariga-oka, Fukushima, Fukushima, 960-1297, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Murakawa', 'Affiliation': 'Department of Anesthesiology, Fukushima Medical University, 1, Hikariga-oka, Fukushima, Fukushima, 960-1297, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02829-0']
2815,32693177,Enhancing employer coverage of smoking cessation treatment: A randomized trial of the Partners in Helping You Quit (PiHQ) program.,"The workplace is a key channel for delivering tobacco cessation treatment to a population. Employers can provide workplace-based programs and/or financial incentives such as health insurance benefits that cover the cost of treatment accessed outside the workplace. Little is known about the effect of combining these strategies. We tested the benefit of adding a workplace cessation program, Partners in Helping You Quit (PiHQ), to comprehensive health insurance coverage of smoking cessation medications by Partners HealthCare, a large Boston-based healthcare delivery system. PiHQ offers biweekly telephone-based behavioral support, additional automated calls, and medication care coordination for 3 months then monthly telephone monitoring for 9 months. In a pragmatic randomized trial, employees who smoked were informed about the insurance benefit, then randomly assigned (2:1) to PiHQ or to active referral to a free 3-month phone-based community program, Massachusetts Quitline (QL). Outcomes were assessed at 3, 6, and 12 months. During 2015-2018, 106 smokers (n = 73 PiHQ, n = 33 QL) enrolled (64% female; 75% white, 21% black; mean age 46 years, mean cigarettes/day = 13). More PiHQ than QL participants made a quit attempt by 3 months (82 vs. 61%, p < .02) and achieved the primary outcome, verified past 7-day cigarette abstinence at 6 months (31 vs. 12%, odds ratio 3.34, 95% CI, 1.05-10.60). Among participants using behavioral support, PiHQ participants completed more scheduled calls and rated counseling helpfulness higher than did QL participants. These results suggest that employers can enhance the impact of providing comprehensive health insurance coverage of smoking cessation medication by adding a phone-based worksite cessation program.",2020,"More PiHQ than QL participants made a quit attempt by 3 months (82 vs. 61%, p < .02) and achieved the primary outcome, verified past 7-day cigarette abstinence at 6 months (31 vs. 12%, odds ratio 3.34, 95%CI, 1.05-10.60).","['During 2015-2018, 106 smokers (n\u202f=\u202f73 PiHQ, n\u202f=\u202f33 QL) enrolled (64% female; 75% white, 21% black; mean age 46\u202fyears, mean cigarettes/day\u202f=\u202f13']","['PiHQ or to active referral to a free 3-month phone-based community program, Massachusetts Quitline (QL', 'workplace cessation program, Partners in Helping You Quit (PiHQ']","['scheduled calls and rated counseling helpfulness', '7-day cigarette abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.052749,"More PiHQ than QL participants made a quit attempt by 3 months (82 vs. 61%, p < .02) and achieved the primary outcome, verified past 7-day cigarette abstinence at 6 months (31 vs. 12%, odds ratio 3.34, 95%CI, 1.05-10.60).","[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine and Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America; Department of Medicine, Harvard Medical School, Boston, MA, United States of America. Electronic address: Rigotti.Nancy@mgh.harvard.edu.'}, {'ForeName': 'Jennifer H K', 'Initials': 'JHK', 'LastName': 'Kelley', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine and Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine and Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America; Department of Medicine, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Inman', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine and Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kalkhoran', 'Affiliation': 'Tobacco Research and Treatment Center, Division of General Internal Medicine and Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America; Department of Medicine, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaster', 'Affiliation': ""Department of Medicine, Harvard Medical School, Boston, MA, United States of America; Population Health, Partners HealthCare, Inc., Boston, MA, United States of America; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Sreekanth K', 'Initials': 'SK', 'LastName': 'Chaguturu', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, MA, United States of America; Population Health, Partners HealthCare, Inc., Boston, MA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106216']
2816,32694412,"Advanced HIV disease in the Botswana combination prevention project: prevalence, risk factors, and outcomes.","OBJECTIVE(S)


To determine the proportion of individuals linking to HIV-care with advanced HIV-disease (CD4 cell counts ≤200 cells/μl) in the Botswana Combination Prevention Project, describe the characteristics of these individuals, and examine treatment outcomes.
DESIGN


A subanalysis of a cluster-randomized HIV-prevention trial. HIV status was assessed in 16-64-year-olds through home and mobile testing. All HIV-positive persons not on antiretroviral therapy were referred to local Ministry of Health and Wellness clinics for treatment.
METHODS


Analysis was restricted to the 15 intervention clusters. The proportion of individuals with advanced HIV disease was determined; associations between advanced HIV disease and sex and age explored; and rates of viral suppression determined at 1-year. Mortality and retention in care were compared between CD4 strata (CD4 cell counts ≤200 vs. >200 cells/μl).
RESULTS


Overall, 17.2% [430/2499; 95% confidence interval (CI) 15.7-18.8%] of study participants had advanced HIV disease (CD4 cell counts ≤200 cells/μl) at time of clinic linkage. Men were significantly more likely to present with CD4 cell counts 200 cells/μl or less than women [23.7 vs. 13.4%, adjusted odds ratio 1.9, 95% CI 1.5-2.3]. The risk of advanced HIV disease increased with increasing age (adjusted odds ratio 2.2, 95% CI 1.4-3.2 >35 vs. <25 years). Patients with CD4 cell counts 200 cells/μl or less had significantly higher rates of attrition from care during follow-up (hazards ratio 1.47, 95% CI 1.1-2.1).
CONCLUSION


Advanced HIV disease due to late presentation to or disengagement from antiretroviral therapy care remains common in the Treat All era in Botswana, calling for innovative testing, linkage, and treatment strategies to engage and retain harder-to-reach populations in care.",2020,"The risk of advanced HIV disease increased with increasing age (aOR 2.2, 95% CI 1.4-3.2 > 35 years versus < 25 years).","['individuals linking to HIV-care with advanced HIV-disease (CD4 ≤200\u200acells/μL', 'All HIV-positive persons not on antiretroviral-therapy (ART) were referred to local Ministry of Health and Wellness clinics for treatment']",[],"['Mortality and retention in care', 'rates of attrition from care', 'viral suppression', 'advanced HIV disease', 'HIV status', 'proportion of individuals with advanced HIV disease', 'risk of advanced HIV disease']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.286856,"The risk of advanced HIV disease increased with increasing age (aOR 2.2, 95% CI 1.4-3.2 > 35 years versus < 25 years).","[{'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Botswana Ministry of Health and Wellness.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mills', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Chipo', 'Initials': 'C', 'LastName': 'Mogorosi', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Ussery', 'Affiliation': 'Division of Global HIV/AIDS and TB, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Tafireyi', 'Initials': 'T', 'LastName': 'Marukutira', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Theu', 'Affiliation': 'Botswana Ministry of Health and Wellness.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Kapanda', 'Affiliation': 'Botswana Ministry of Health and Wellness.'}, {'ForeName': 'Stembile', 'Initials': 'S', 'LastName': 'Matambo', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Northrop Grumman, Atlanta, Georgia, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Raizes', 'Affiliation': 'Division of Global HIV/AIDS and TB, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': 'Botswana-Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Division of Global HIV/AIDS and TB, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Division of Global HIV/AIDS and TB, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Jarvis', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002627']
2817,32697618,Methyldopa versus labetalol or no medication for treatment of mild and moderate chronic hypertension during pregnancy: a randomized clinical trial.,"OBJECTIVE


to assess the maternal and fetal outcome in women with mild to moderate chronic hypertension on antihypertensive drug (methyldopa or labetalol) therapy compared to no medication.
METHODS


This multicenter randomized clinical study was conducted at Menoufia University hospital, Shibin El-kom Teaching hospital at Menoufia governorate, Egypt.486 pregnant women with mild to moderate chronic hypertension were randomized into three groups; methyldopa group (n = 164), labetalol group (n = 160), and control or no medication group (n = 162) who were followed from the beginning of pregnancy till the end of puerperium to record maternal and fetal outcome.
RESULTS


There was a highly significant difference between treatment groups (methyldopa and labetalol) and control group regarding the development of maternal severe hypertension, development of preeclampsia, renal impairment, presence of ECG changes, placental abruption, and repeated admission to hospital for blood pressure control (p < 0.001) with higher occurrence in the control (no treatment) group. Neonates in the labetalol group were more prone for the development of small for gestational age (SGA), neonatal hypotension, neonatal hyperbilirubinemia, and admission to NICU than their counterparts in the methyldopa and control groups (p < 0.001). The rate of prematurity was significantly higher in the control group than the treatment groups (p < 0.05).
CONCLUSION


Treatment of mild to moderate chronic hypertension during pregnancy is beneficial in decreasing both maternal and fetal morbidity. The use of labetalol was associated with higher rates of SGA, neonatal hypotension, and neonatal hyperbilirubinemia compared to methyldopa or no medication.",2020,"The rate of prematurity was significantly higher in the control group than the treatment groups (p < 0.05).
","['women with mild to moderate chronic hypertension on antihypertensive drug (methyldopa or labetalol) therapy compared to no medication', 'Menoufia University hospital, Shibin El-kom Teaching hospital at Menoufia governorate, Egypt.486 pregnant women with mild to moderate chronic hypertension', 'mild and moderate chronic hypertension during pregnancy']","['Methyldopa', 'labetalol or no medication', 'methyldopa', 'labetalol group (n\xa0=\xa0160), and control or no medication group', 'labetalol']","['development of small for gestational age (SGA), neonatal hypotension, neonatal hyperbilirubinemia, and admission to NICU', 'maternal severe hypertension, development of preeclampsia, renal impairment, presence of ECG changes, placental abruption, and repeated admission to hospital for blood pressure control', 'rates of SGA, neonatal hypotension, and neonatal hyperbilirubinemia', 'rate of prematurity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0574690', 'cui_str': 'Komi language'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0025741', 'cui_str': 'Methyldopa'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0455995', 'cui_str': 'Neonatal hypotension'}, {'cui': 'C0857007', 'cui_str': 'Neonatal hyperbilirubinemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0855329', 'cui_str': 'Electrocardiogram change'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",,0.0339825,"The rate of prematurity was significantly higher in the control group than the treatment groups (p < 0.05).
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Rezk', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University , Shibin Al Kawm, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Emarh', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University , Shibin Al Kawm, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Masood', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University , Shibin Al Kawm, Egypt.'}, {'ForeName': 'Ragab', 'Initials': 'R', 'LastName': 'Dawood', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University , Shibin Al Kawm, Egypt.'}, {'ForeName': 'Elsayed', 'Initials': 'E', 'LastName': 'El-Shamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Menoufia University , Shibin Al Kawm, Egypt.'}, {'ForeName': 'Awni', 'Initials': 'A', 'LastName': 'Gamal', 'Affiliation': 'Department of Cardiology, Menoufia University , Shibin Al Kawm, Egypt.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Badr', 'Affiliation': 'Department of Pediatrics, Menoufia University , Shibin Al Kawm, Egypt.'}]",Hypertension in pregnancy,['10.1080/10641955.2020.1791902']
2818,32700585,"Severe, transient pulmonary ventilation-perfusion mismatch in the lung after porcine high velocity projectile behind armor blunt trauma.","BACKGROUND


Behind armor blunt trauma (BABT) is a non-penetrating injury caused by the rapid deformation of body armor, by a projectile, which may in extreme circumstances cause death. Although there is not a high incidence of high energy BABT, the understanding of the mechanisms is still low, in relation to what is needed for safety threshold levels. BABT is also useful as a model for blunt thoracic trauma, with a compressive speed between traffic accidents and blast caused by explosives. High velocity projectile BABT causes severe hypoxia. The mechanisms are not fully known. We investigated the acute pulmonary consequences in the individual lungs, and the effects of alveolar recruitment.
METHODS


12 swine (mean weight 62.5 kg) were randomized to groups BABT by 7.62 × 51 mm NATO-type bullets (mean velocity 803 m/s) to a military grade ceramic plate armor (n = 7) or control (n = 5). Modified double lumen tracheal tubes provided respiratory dynamics in the lungs separately/intermittently for two hours, with alveolar recruitment after one hour.
RESULTS


Venous admixture increased 5 min after BABT (p < .05) and correlated with increased cardiac output. Static compliance decreased 5 minutes after BABT (p < .05) and further by recruitment (p < .005). Physiological dead space decreased 5 minutes after BABT (p < .01) and further by recruitment (p < .01), while not in the contralateral lung. V'A/Q' decreased 5 minutes after BABT (p < .05), also shown in phase III volumetric capnography (p < .05). Most effects regressed after one hour.
CONCLUSIONS


High velocity projectile BABT caused hypoxia by a severe and transient decrease in V'A/Q' to <1 and increased venous admixture in the exposed lung. Alveolar recruitment was hemodynamically and respiratory tolerable and increased V'A/Q'. Body armor development should aim at ameliorating severe pulmonary consequences from high projectile velocities which also needs to include further understanding of how primary and secondary effects are distributed between the lungs.",2020,"RESULTS


Venous admixture increased 5 min after BABT (p < .05) and correlated with increased cardiac output.","['12 swine ', 'mean weight 62.5\u2009kg']","['military grade ceramic plate armor (n\u2009=\u20097) or control', 'BABT']","['cardiac output', 'Venous admixture increased 5\u2009min after BABT', ""Alveolar recruitment was hemodynamically and respiratory tolerable and increased V'A/Q"", 'Physiological dead space', ""V'A/Q"", 'Static compliance']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0231936', 'cui_str': 'Normal ventilation-perfusion ratio'}, {'cui': 'C0231975', 'cui_str': 'Physiological dead space'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}]",,0.039932,"RESULTS


Venous admixture increased 5 min after BABT (p < .05) and correlated with increased cardiac output.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rocksén', 'Affiliation': 'Department of Neuroscience, section of Experimental Traumatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulf P', 'Initials': 'UP', 'LastName': 'Arborelius', 'Affiliation': 'Department of Neuroscience, section of Experimental Traumatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Neuroscience, section of Experimental Traumatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Günther', 'Affiliation': 'Department of Clinical Science and Education, Section of Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden.'}]",Experimental lung research,['10.1080/01902148.2020.1797246']
2819,32702699,Brain Imaging Signs and Health-Related Quality of Life after Acute Ischemic Stroke: Analysis of ENCHANTED Alteplase Dose Arm.,"BACKGROUND AND PURPOSE


The influence of specific brain lesions on health-related quality of life (HRQoL) after acute ischemic stroke (AIS) is uncertain. We aimed to identify imaging predictors of poor HRQoL in alteplase-treated participants of the alteplase dose arm of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS


ENCHANTED was an international trial of low- versus standard-dose intravenous alteplase in AIS patients, with functional outcome (modified Rankin scale [mRS]) and HRQoL on the 5-dimension European Quality of Life Scale (EQ-5D) assessed at 90 days post-randomization. Brain images were analyzed centrally by trained assessors. Multivariable logistic regression was undertaken in the study population randomly divided (2:1) into training (development) and validation (performance) groups, with age (per 10-year increase), ethnicity, baseline National Institutes of Health Stroke Scale (NIHSS) score, diabetes mellitus, premorbid function (mRS score 0 or 1), and proxy respondent, forced into all models. Data are presented with odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS


Eight prediction models were developed and validated in 2,526 AIS patients (median age 67.5 years; 38.4% female; 61.7% Asian) with complete brain imaging and 90-day EQ-5D utility score data. The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions. Several background features of brain frailty - atrophy, white matter change, and old infarcts - were significantly associated with adverse physical but not emotional HRQoL domains.
CONCLUSIONS


In thrombolysed AIS patients, right-sided and deep ischemia within the MCA territory predict poor overall HRQoL, whilst features of old cerebral ischemia are associated with reduced physical HRQoL.",2020,"The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions.","['2,526 AIS patients (median age 67.5 years; 38.4% female; 61.7% Asian) with', 'after Acute Ischemic Stroke']",['low- versus standard-dose intravenous alteplase'],"['health-related quality of life (HRQoL', 'right-sided and deep ischemia', 'Health Stroke Scale (NIHSS', 'score, diabetes mellitus', 'functional outcome (modified Rankin scale [mRS]) and HRQoL on the 5-dimension European Quality of Life Scale (EQ-5D', 'physical HRQoL', 'complete brain imaging and 90-day EQ-5D utility score data', 'acute ischemic changes', 'Brain Imaging Signs and Health-Related Quality of Life', 'premorbid function (mRS score 0 or 1), and proxy respondent']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]",2526.0,0.097416,"The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions.","[{'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'The George Institute China at Peking University Health Science Centre, Beijing, China.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Torii-Yoshimura', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia, canderson@george.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000509226']
2820,32703613,Effects of a Single Myofascial Induction Session on Neural Mechanosensitivity in Breast Cancer Survivors: A Secondary Analysis of a Crossover Study.,"OBJECTIVES


The purpose of this study was to investigate the short-term effects of myofascial induction on mechanosensitivity of upper limb nerves.
METHODS


In this secondary analysis of a randomized, single-blind, placebo-controlled crossover study, 21 breast cancer survivors with stage I-IIIA cancer were randomly allocated to an experimental group (30 minutes of myofascial induction session) or placebo control group (unplugged pulsed 30 minutes of shortwave therapy), with a 4-week washout period between sessions that occurred in a physical therapy laboratory in the Health Science Faculty (University of Granada, Spain). Range of motion (universal goniometry), structural differentiation, symptoms (yes/no), and pressure pain thresholds (electronic algometry) were assessed during neurodynamic tests and attitude toward massage scale as covariate.
RESULTS


An analysis of covariance revealed significant time × group interactions for range of motion in affected upper limb nerves (median, P < .001; radial, P = .036; ulnar, P = .002), but not for nonaffected upper limb nerves (median, P = .083; radial, P = .072; ulnar, P = .796). A χ 2  or Fisher exact test, as appropriate, also revealed a significant difference (P = .044) in sensitivity for the affected upper limb ulnar nerve in the experimental group, whereas the rest of the assessed nerves (affected and nonaffected upper limb nerves) showed no significant changes in either the experimental or control groups (P > .05). An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves.
CONCLUSION


A single myofascial induction session may partially improve mechanosensitivity of median, radial, and ulnar nerves and yield positive effects on symptom mechanosensitivity, especially regarding the ulnar nerve in breast cancer survivors.",2020,"An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves.
","['Breast Cancer Survivors', '21 breast cancer survivors with stage I-IIIA cancer']","['placebo control group (unplugged pulsed 30 minutes of shortwave therapy', 'myofascial induction', 'Single Myofascial Induction Session', 'placebo']","['pressure pain thresholds', 'Range of motion (universal goniometry), structural differentiation, symptoms (yes/no), and pressure pain thresholds (electronic algometry', 'Neural Mechanosensitivity', 'mechanosensitivity of median, radial, and ulnar nerves']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0037000', 'cui_str': 'Short Wave Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}]",21.0,0.0523857,"An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves.
","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castro-Martín', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain. Electronic address: noeliagaliano@ugr.es.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ortiz-Comino', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.03.016']
2821,32701419,A Randomized and Controlled Acceptability Trial of an Internet-based Therapy among Inpatients with Co-occurring Substance Use and Other Psychiatric Disorders.,"OBJECTIVES


Technology-assisted treatment (TAT) holds promise for innovative assessment, prevention, and treatment of substance use disorders (SUD). The widespread access to TAT makes it a potentially cost-effective and inventive option available for delivery in multiple settings. This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders.  Methods:  Eligible participants were nonpsychotic, voluntary patients with self-reported drug or alcohol use in the 30 days prior to admission. They were randomly assigned to treatment as usual (TAU,  n  = 47) or TAU + TES ( n  = 48). Acceptability of this Internet-based intervention was assessed by observed utilization and self-report.  Results:  The TAU + TES group (# analyzed = 41) completed a mean total of 5.5 ( SEM  = 0.8) modules with about one module per day while hospitalized and rated TES highly on several constructs of acceptability, including novelty, usefulness and ease of understanding.  Conclusions:  These findings support further exploration of TAT for treatment expansion in a high acuity, dual diagnosis population and indicate the value of future research on efficacy.  ClinicalTrials.gov Identifier:  NCT02674477.",2020,This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders.  ,"['hospitalized dual diagnosis patients with SUDs and other psychiatric disorders', 'Inpatients with Co-occurring Substance Use and Other Psychiatric Disorders', 'Eligible participants were nonpsychotic, voluntary patients with self-reported drug or alcohol use in the 30 days prior to admission']","['Internet-based Therapy', 'TAT', 'web-based Therapeutic Education System (TES', 'usual (TAU,  n \u2009=\u200947) or TAU\u2009+\u2009TES', 'Technology-assisted treatment (TAT']","['acceptability, including novelty, usefulness and ease of understanding']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0580276', 'cui_str': 'Informal patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",,0.0530963,This study assessed acceptability of the web-based Therapeutic Education System (TES) in hospitalized dual diagnosis patients with SUDs and other psychiatric disorders.  ,"[{'ForeName': 'Alexis S', 'Initials': 'AS', 'LastName': 'Hammond', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Antoine', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Strain', 'Affiliation': 'Behavioral Pharmacology Research Unit, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2020.1794094']
2822,32709513,Three-Dimensional Spinal Position With and Without Manual Distraction Load Increases Spinal Height.,"OBJECTIVE


The purpose of this study was to investigate if spinal height increases using 3-dimensional (3-D) spinal position with and without manual distraction load and to assess the correlation between spine height changes and degrees of trunk rotation.
METHODS


Fifty-six participants were randomly placed in one of two groups: (1) 3-D spinal position with manual distraction load, and (2) without manual distraction load. Spinal height was measured before and after the interventions using a stadiometer. For the statistical analysis, we used a 2 (Loading status: pre- versus post-intervention height) X 2 (3-D spinal position: with versus without manual distraction load) repeated measures Analysis of Variance (ANOVA) was used to identify significant interaction and main effects. Paired t-tests were used to calculate differences in spinal height changes between the two interventions. Pearson correlation coefficient was used to measure correlations between changes in spinal heights and degrees of trunk rotation.
RESULTS


Mean spinal height increase with 3-D spinal position with and without manual distraction load was 6.30 mm (±6.22) and 5.69 mm (±4.13), respectively. No significant interaction effect was present between loading status and 3-D spinal position but a significant main effect in loading status was. Paired t-tests revealed significant differences in spinal heights between pre-and post-3-D spinal position with and without manual distraction load. No significant correlation was measured between trunk rotation and spinal height changes.
CONCLUSION


3-D spinal position with or without distraction load increased spinal height. This suggests that 3-D spinal positioning without manual distraction could be used in home settings to help maintain intervertebral disc (IVD) health.",2020,No significant interaction effect was present between loading status and 3-D spinal position but a significant main effect in loading status was.,['Fifty-six participants'],"['3-D spinal position with manual distraction load, and (2) without manual distraction load', '3-dimensional (3-D) spinal position with and without manual distraction load']","['Mean spinal height increase with 3-D spinal position', 'trunk rotation and spinal height changes', 'spinal heights and degrees of trunk rotation', 'spinal height changes', 'spinal heights', 'spinal height', 'Spinal height']",[],"[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557899', 'cui_str': 'Height increased'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",56.0,0.0215252,No significant interaction effect was present between loading status and 3-D spinal position but a significant main effect in loading status was.,"[{'ForeName': 'Sohal S', 'Initials': 'SS', 'LastName': 'Hallur', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Brismée', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX. Electronic address: jm.brismee@ttuhsc.edu.'}, {'ForeName': 'Phillip S', 'Initials': 'PS', 'LastName': 'Sizer', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dierick', 'Affiliation': ""Centre National de R é education Fonctionnelle et de R éadaptation-Rehazenter, Laboratoire d'Analyse du Mouvement et de la Posture (LAMP), Luxembourg, Grand Duchy of Luxembourg.""}, {'ForeName': 'Birendra M', 'Initials': 'BM', 'LastName': 'Dewan', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thiry', 'Affiliation': 'Forme & Fonctionnement Humain Laboratory, Physical Therapy Department, CERISIC, Haute Ecole Louvain en Hainaut & Université Catholique de Louvain, Faculty of Motor Sciences, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Sobczak', 'Affiliation': ""Research Unit in Clinical and Functional Anatomy, Départment d'anatomie, Université du Québec à Trois-Rivières, Canada.""}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.04.007']
2823,32706639,"Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer.","PURPOSE


Radical prostatectomy (RP) alone is often inadequate in curing men with clinically localized, high-risk prostate cancer (PC). We hypothesized that chemohormonal therapy (CHT) with androgen-deprivation therapy plus docetaxel before RP would improve biochemical progression-free survival (BPFS) over RP alone.
PATIENTS AND METHODS


Men with clinically localized, high-risk PC were assigned to RP alone or neoadjuvant CHT with androgen deprivation plus docetaxel (75 mg/m 2  body surface area every 3 weeks for 6 cycles) and RP. The primary end point was 3-year BPFS. Biochemical failure was defined as a serum prostate-specific antigen level > 0.2 ng/mL that increased on 2 consecutive occasions that were at least 3 months apart. Secondary end points included 5-year BPFS, overall BPFS, local recurrence, metastasis-free survival (MFS), PC-specific mortality, and overall survival (OS).
RESULTS


In total, 788 men were randomly assigned. Median follow-up time was 6.1 years. The overall rates of grade 3 and 4 adverse events during chemotherapy were 26% and 19%, respectively. No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89  v  0.84, respectively; 95% CI for the difference, -0.01 to 0.11;  P  = .11). Neoadjuvant CHT was associated with improved overall BPFS (hazard ratio [HR], 0.69; 95% CI, 0.48 to 0.99), improved MFS (HR, 0.70; 95% CI, 0.51 to 0.95), and improved OS (HR, 0.61; 95% CI, 0.40 to 0.94) compared with RP alone.
CONCLUSION


The primary study end point, 3-year BPFS, was not met. Although some improvement was seen in secondary end points, any potential benefit must be weighed against toxicity. Our data do not support the routine use of neoadjuvant CHT and RP in patients with clinically localized, high-risk PC at this time.",2020,"No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89  v  0.84, respectively; 95% CI for the difference, -0.01 to 0.11;  P  = .11).","['Cancer and Leukemia Group B 90203 (Alliance', '788 men were randomly assigned', 'curing men with clinically localized, high-risk prostate cancer (PC', 'Men with clinically localized, high-risk PC']","['Neoadjuvant CHT', 'RP alone or neoadjuvant CHT with androgen deprivation plus docetaxel', 'chemohormonal therapy (CHT) with androgen-deprivation therapy plus docetaxel', 'Radical prostatectomy (RP) alone', 'Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy']","['overall rates of grade 3 and 4 adverse events', 'MFS', 'overall BPFS', '3-year BPFS', 'Biochemical failure', '5-year BPFS, overall BPFS, local recurrence, metastasis-free survival (MFS), PC-specific mortality, and overall survival (OS', 'biochemical progression-free survival (BPFS']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",788.0,0.220039,"No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89  v  0.84, respectively; 95% CI for the difference, -0.01 to 0.11;  P  = .11).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Eastham', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Heller', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Monk', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, The James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Himisha', 'Initials': 'H', 'LastName': 'Beltran', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gleave', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Evans', 'Affiliation': 'University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Clinton', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, The James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Colleen R', 'Initials': 'CR', 'LastName': 'Watt', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Sanda', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Olwen M', 'Initials': 'OM', 'LastName': 'Hahn', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'University of California, San Diego, San Diego, CA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, Medical Center-Mount Zion, San Francisco, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00315']
2824,33217593,Effect of Toremifene on Endometrium and Neurocognitive Function in Patients with Breast Cancer Based on Resting State Functional MRI.,"The paper used toremifene to study the characteristics of hemodynamic changes before and after neoadjuvant chemotherapy in breast cancer by using resting state functional MRI quantitative method, and to analyse the effect of toremifene on the recent quality of life of advanced breast cancer. Methods: A total of 100 patients who received endocrine therapy after breast cancer surgery in our hospital from January 2016 to January 2019 were collected as the research objects. They were randomly divided into observation group and control group, with 50 cases in each group. The observation group was treated with tamoxifen Combined toremifene treatment, the control group was treated with toremifene. Before and after chemotherapy, the same scheme was used to perform breast dynamic MRI enhancement scan, using 1.5T superconducting MRI imager, 3ml/s bolus injection of adiphenine meglumine 0.2mmol/kg; semi-quantitative blood flow measurement was completed on the workstation, and before and after chemotherapy Compare the results. At the same time, analyse the patient's recent quality of life, progesterone, estrogenic levels, social function, physical function, mental function, and material function. The mean values of the early enhancement parameters Efirst, Vfirst, Ee and Ve before chemotherapy were greater than the residual lesions after chemotherapy (P<0.5). The semi-quantitative study of resting brain function before and after breast cancer neoadjuvant chemotherapy showed that the hemodynamic of the residual lesions were significantly reduced, and the blood flow rate was significantly reduced. Compared with the clinical effect of tamoxifen in the treatment of breast cancer after surgery, tamoxifen combined with toremifene has more advantages in improving the recent quality of life, progesterone levels, and reducing estrogenic levels, and it has no disadvantages to the endometrium influences.",2020,"The mean values of the early enhancement parameters Efirst, Vfirst, Ee and Ve before chemotherapy were greater than the residual lesions after chemotherapy (P<0.5).","['advanced breast cancer', 'after breast cancer surgery in our hospital from January 2016 to January 2019 were collected as the research objects', '100 patients who received', 'Patients with Breast Cancer Based on Resting State Functional MRI']","['adiphenine meglumine', 'tamoxifen Combined toremifene', 'toremifene', 'endocrine therapy', 'Toremifene', 'tamoxifen']","['blood flow rate', 'mean values of the early enhancement parameters Efirst, Vfirst, Ee and Ve before chemotherapy', 'quality of life, progesterone, estrogenic levels, social function, physical function, mental function, and material function', 'Endometrium and Neurocognitive Function', 'hemodynamic of the residual lesions']","[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0001521', 'cui_str': 'adiphenine'}, {'cui': 'C0025179', 'cui_str': 'Meglumine'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0076836', 'cui_str': 'Toremifene'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0563143', 'cui_str': 'Mental function'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",100.0,0.0129719,"The mean values of the early enhancement parameters Efirst, Vfirst, Ee and Ve before chemotherapy were greater than the residual lesions after chemotherapy (P<0.5).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Obstetrics and Gynecology, Shanghai Sixth People's Hospital, Shanghai, 200233, China.""}, {'ForeName': 'Yijin', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Obstetrics and Gynecology, Shanghai Sixth People's Hospital, Shanghai, 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Obstetrics and Gynecology, Shanghai Sixth People's Hospital, Shanghai, 200233, China.""}, {'ForeName': 'Joh', 'Initials': 'J', 'LastName': 'Nowen', 'Affiliation': 'Department of Electrical and Electronics Engineering, Istanbul University, 34320 Istanbul, Turkey.'}]",World neurosurgery,['10.1016/j.wneu.2020.11.051']
2825,32701199,"A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Regorafenib Versus Placebo in Advanced/Metastatic, Treatment-Refractory Liposarcoma: Results from the SARC024 Study.","TRIAL INFORMATION


ClinicalTrials.gov Identifier: NCT02048371 Sponsors: SARC, with support from Bayer HealthCare Pharmaceuticals (Berlin, Germany) Principal Investigator: Richard F. Riedel IRB Approved: Yes LESSONS LEARNED: The results from the liposarcoma cohort of SARC024 confirm previously published data and do not support the routine use of regorafenib in this patient population. Continued exploration of novel therapies, including combination approaches, is warranted for a patient population in whom limited treatment options exist.
BACKGROUND


Regorafenib is a multitargeted kinase inhibitor with a kinase profile overlapping, but distinct from, pazopanib, an agent approved for recurrent and metastatic non-gastrointestinal stromal tumor (GIST), non-adipocytic soft tissue sarcoma. We conducted a randomized, phase II study of regorafenib versus placebo in refractory liposarcoma patients.
METHODS


Patients with advanced or metastatic, treatment-refractory liposarcoma were randomized 1:1 to receive regorafenib 160 mg or placebo once daily (3 weeks on, 1 week off). Patients with well-differentiated liposarcoma only were excluded. Crossover for placebo was allowed upon progression. The primary endpoint was progression-free survival (PFS), according to RECIST version 1.1.
RESULTS


Forty-eight subjects with liposarcoma (34 dedifferentiated, 12 myxoid/round cell, 2 pleomorphic) were enrolled. Median PFS was 1.87 (95% confidence interval [CI], 0.92-3.67) months for regorafenib versus 2.07 (95% CI, 1.64-3.44) months for placebo; stratified hazard ratio [HR], 0.85 (95% CI, 0.46, 1.58), p = .62. No responses were seen on regorafenib. One PR was observed on placebo. Median overall survival was 6.46 (95% CI, 4.16-23.48) months for regorafenib and 4.89 (95% CI, 3.02-9.77) months for placebo, stratified HR, 0.66 (95% CI, 0.31-1.40), p = .28). Treatment-related adverse events were similar to the known safety profile of regorafenib.
CONCLUSION


Regorafenib did not appear to improve PFS in treatment-refractory liposarcoma. No new significant safety signals were observed.",2020,Median PFS was 1.87 (95% confidence interval [CI]: 0.92-3.67) months for regorafenib versus 2.07 (95% CI: 1.64-3.44) months for placebo; stratified hazard ratio [HR] 0.85,"['Advanced/Metastatic, Treatment-Refractory Liposarcoma', 'Patients with well-differentiated liposarcoma only were excluded', 'Patients with advanced/metastatic, treatment-refractory liposarcoma', 'Forty-eight subjects with liposarcoma (34 dedifferentiated, 12 myxoid/round cell, 2 pleomorphic) were enrolled', 'refractory liposarcoma patients']","['Regorafenib vs. Placebo', 'Placebo', 'regorafenib 160 mg or placebo', 'Regorafenib', 'regorafenib versus placebo', 'placebo']","['Median overall survival', 'Median PFS', 'PFS', 'progression-free survival (PFS), according to RECIST version 1.1']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205295', 'cui_str': 'Myxoid'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",48.0,0.650568,Median PFS was 1.87 (95% confidence interval [CI]: 0.92-3.67) months for regorafenib versus 2.07 (95% CI: 1.64-3.44) months for placebo; stratified hazard ratio [HR] 0.85,"[{'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Riedel', 'Affiliation': 'Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Loggers', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Ganjoo', 'Affiliation': 'Stanford Cancer Institute, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Livingston', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Chow', 'Affiliation': 'City of Hope Cancer Center, Duarte, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Ward', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rushing', 'Affiliation': 'Melvin and Bren Simon Cancer Center, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Okuno', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Damon R', 'Initials': 'DR', 'LastName': 'Reed', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Liebner', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Vicki L', 'Initials': 'VL', 'LastName': 'Keedy', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital of Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.""}, {'ForeName': 'Lara E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Reinke', 'Affiliation': 'Sarcoma Alliance for Research through Collaboration (SARC), Ann Arbor, Michigan, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0679']
2826,32710304,Early surfactant replacement guided by lung ultrasound in preterm newborns with RDS: the ULTRASURF randomised controlled trial.,"This study aimed to investigate whether using lung ultrasound (LUS) scores in premature newborns with respiratory distress syndrome (RDS) allows for earlier surfactant therapy (within the first 3 h of life) than using FiO 2  criteria. This was a randomised, non-blinded clinical trial conducted in a neonatal intensive care unit. The inclusion criteria were newborns with a gestational age of ≤ 32 weeks and RDS. Patients meeting the inclusion criteria were randomly assigned to two groups: the ultrasound group, administered surfactant based on LUS score and/or FiO 2  threshold, and the control group, guided by FiO 2  only. Fifty-six patients were included. The ultrasound group received surfactant earlier (1 h of life vs. 6 h, p < 0.001), with lower FiO 2  (25% vs. 30%, p = 0.016) and lower CO 2  (48 vs. 54, p = 0.011). After surfactant treatment, newborns in the ultrasound group presented a greater SpO 2  (p = 0.001) and SpO 2 /FiO 2  ratio (p = 0.012).Conclusions: LUS score allowed an earlier surfactant therapy, reduced oxygen exposure early in life and a better oxygenation after the treatment. This early surfactant replacement may lead to reduced oxygen exposure. What is Known: • Lung ultrasound scores predict the need for surfactant therapy in premature newborns. What is New: • This study shows that using lung ultrasound scores improves the timeliness of surfactant replacement compared with using FiO 2  alone.",2020,"The ultrasound group received surfactant earlier (1 h of life vs. 6 h, p < 0.001), with lower FiO 2  (25% vs. 30%, p = 0.016) and lower CO 2  (48 vs. 54, p = 0.011).","['premature newborns', 'preterm newborns with RDS', 'Patients meeting the inclusion criteria', 'newborns with a gestational age of ≤ 32 weeks and RDS', 'premature newborns with respiratory distress syndrome (RDS', 'Fifty-six patients were included']","['surfactant replacement guided by lung ultrasound', 'surfactant therapy', 'lung ultrasound (LUS) scores', 'ultrasound group, administered surfactant based on LUS score and/or FiO 2  threshold, and the control group, guided by FiO 2  only']",['oxygen exposure early in life and a better oxygenation'],"[{'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",56.0,0.110221,"The ultrasound group received surfactant earlier (1 h of life vs. 6 h, p < 0.001), with lower FiO 2  (25% vs. 30%, p = 0.016) and lower CO 2  (48 vs. 54, p = 0.011).","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodriguez-Fanjul', 'Affiliation': 'Neonatal Intensive Care Unit, Paediatrics Department, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain. javier.rodriguez.fanjul@gmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jordan', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balaguer', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Batista-Muñoz', 'Affiliation': 'Neonatal Intensive Care Unit, Paediatrics Department, Hospital Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramon', 'Affiliation': 'Neonatal Intensive Care Unit, Paediatrics Department, Hospital Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bobillo-Perez', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}]",European journal of pediatrics,['10.1007/s00431-020-03744-y']
2827,32698326,Psychometric and Structural Validity of the Pittsburgh Sleep Quality Index among Filipino Domestic Workers.,"Objectives : Evaluate the psychometric properties and structural validity of the Filipino version of the Pittsburgh Sleep Quality Index (PSQI) among Filipino domestic workers (FDWs).  Methods : In Study 1, 131 FDWs completed PSQI and other scales, along with 10-day actigraphic assessment with accompanying electronic daily sleep dairy. A subsample of 61 participants completed follow-up assessment after 10 days. In Study 2, 1363 FDWs were recruited and randomized into two halves. Exploratory factor analysis (EFA) and Confirmatory factor analysis (CFA) were used in the two halves, respectively.  Results : In Study 1, the Cronbach's alpha of the PSQI was 0.63 at baseline and 0.67 at follow-up. Test-retest reliability for the PSQI global score based on intraclass correlation was 0.63. Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination. Small correlations between the PSQI global score and measures of daytime sleepiness, social support, and self-reported height, supported discriminant validity. In Study 2, EFA yielded two PSQI factors with acceptable factor loadings. CFA established that this two-factor model, comprised of perceived sleep quality and sleep efficiency, evidenced better model fit than alternative models tested. The Cronbach's alpha of two factors was 0.70 and 0.81, respectively.  Conclusions : The PSQI demonstrated good internal consistency of two factors, and good convergent, and divergent validity. Results can be referenced in future studies to measure and screen sleep dysfunction among clinical and non-clinical populations in the Philippines.",2020,"Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination.","['1363 FDWs', 'Filipino domestic workers (FDWs', 'Filipino Domestic Workers']",['Filipino version of the Pittsburgh Sleep Quality Index (PSQI'],"['Exploratory factor analysis (EFA) and Confirmatory factor analysis (CFA', 'sleep quality and sleep efficiency', 'PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination', 'PSQI global score and measures of daytime sleepiness, social support, and self-reported height', 'Psychometric and Structural Validity of the Pittsburgh Sleep Quality Index']","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",1363.0,0.0399617,"Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiong', 'Affiliation': 'Division of Medical Psychology and Behavioral Sciences, Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Johns Hopkins Center on Aging and Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hall', 'Affiliation': 'Global and Community Mental Health Research Group, Department of Psychology, The University of Macau, Macau (SAR) 999078, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17145219']
2828,32700191,"Pharmacokinetics, Safety, and Tolerability of Intravenous Felbinac Trometamol in Healthy Chinese Volunteers: A First-in-Human Single- and Multiple-Dose Escalation Phase I Study with a Randomized, Double-Blind, Placebo-Controlled Design.","BACKGROUND


Felbinac trometamol, an anti-inflammatory and analgesic drug, has been used to treat immediate postoperative pain.
OBJECTIVE


The aim of this study was to evaluate the safety, tolerability, and pharmacokinetics of single or multiple intravenous infusions of felbinac trometamol in healthy Chinese volunteers.
METHODS


A total of 56 healthy subjects were enrolled in a single-ascending dose study (11.78-377.00 mg), meanwhile 36 subjects were enrolled in a multiple-ascending dose study (47.13-188.50 mg). Safety endpoints included treatment-emergent adverse events, vital signs, electrocardiograms, and laboratory parameters. Pharmacokinetic endpoints included exposure of subjects to felblinac and metabolites of the drug in plasma, urine, and feces.
RESULTS


Felblinac time to maximum plasma concentration was obtained at 0.5 h, corresponding to the end of the infusion. Maximum plasma concentration and area under the curve increased in a dose-dependent manner for felblinac and its metabolite, showing linear pharmacokinetic characteristics at single and multiple doses. After intravenous infusions of multiple doses three times (30 min each time) per day, the accumulation ratio of felblinac and its metabolite based on the area under the curve had a range of 1.34-1.45 and 1.60-1.87, respectively, across cohorts. After administration of the fourth dose, the plasma concentration of both felblinac and its metabolites was maintained at a steady state. Felbinac trometamol was well tolerated. Neither treatment-emergent adverse event frequency nor severity increased with increasing felbinac trometamol dose.
CONCLUSIONS


Felbinac trometamol was well tolerated in our study. Based on the dose range in this study, 94.25 mg is the recommended target dose for a phase II study.
CLINICAL TRIAL REGISTRATION


CTR20170496 and CTR20180896. The dates of registration are 2017-06-19 and 2018-07-02 ( https://www.chinadrugtrials.org.cn/ ).",2020,"Maximum plasma concentration and area under the curve increased in a dose-dependent manner for felblinac and its metabolite, showing linear pharmacokinetic characteristics at single and multiple doses.","['56 healthy subjects were enrolled in a single-ascending dose study (11.78-377.00\xa0mg), meanwhile 36 subjects were enrolled in a multiple-ascending dose study (47.13-188.50\xa0mg', 'healthy Chinese volunteers', 'Healthy Chinese Volunteers']","['Felbinac trometamol', 'Placebo', 'Intravenous Felbinac Trometamol', 'felbinac trometamol']","['tolerated', 'treatment-emergent adverse events, vital signs, electrocardiograms, and laboratory parameters', 'safety, tolerability, and pharmacokinetics', 'Maximum plasma concentration and area under the curve', 'Felblinac time to maximum plasma concentration', 'exposure of subjects to felblinac and metabolites of the drug in plasma, urine, and feces', 'plasma concentration of both felblinac and its metabolites', 'accumulation ratio of felblinac and its metabolite', 'Pharmacokinetics, Safety, and Tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0877860', 'cui_str': 'Felbinac'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",56.0,0.0956679,"Maximum plasma concentration and area under the curve increased in a dose-dependent manner for felblinac and its metabolite, showing linear pharmacokinetic characteristics at single and multiple doses.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Jixuan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Shijiazhuang Yiling Pharmaceutical Co., Ltd, Shijiazhuang, 050035, Hebei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Shijiazhuang Yiling Pharmaceutical Co., Ltd, Shijiazhuang, 050035, Hebei, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, 130021, Jilin, China. dingyanhua2003@126.com.'}]",CNS drugs,['10.1007/s40263-020-00739-z']
2829,32700952,Community-based randomized controlled trial of psychological first aid with crime victims.,"OBJECTIVE


The first randomized controlled trial of psychological first aid (PFA) was conducted, using crime victims as participants. For study Aim 1, investigators tested whether paraprofessional victim advocates could be trained to deliver PFA to crime victims. For study Aim 2, investigators tested the effect of PFA delivery on victims' psychiatric (i.e., symptoms of PTSD, somatization, depression, anxiety, and substance use) and adaptive functioning outcomes.
METHOD


Two law enforcement agencies served as study sites. A dynamic wait-listed design included a phase when advocates at both sites delivered usual services (US) to victims, a phase when one site was randomly selected to deliver PFA while the other delivered US, and a phase when both sites delivered PFA. Across all phases, 172 crime victims (mean age = 36.4 years; 81% female) were recruited, and a battery assessed their psychiatric symptoms and adaptive functioning at baseline and 1, 2, and 4 months postbaseline.
RESULTS


From the US to PFA phases, advocates' PFA adherence (i.e., their delivery of PFA components) increased significantly. PFA did not outperform US with regard to improvement on victims' individual psychiatric and adaptive functioning outcomes. However, on a composite global functioning outcome created for this trial, PFA yielded significantly greater improvement relative to US.
CONCLUSION


Paraprofessional victim advocates have the capacity to deliver PFA. Conclusions regarding the effectiveness of PFA for crime victims vary depending on the nature of the scored outcome variable (individual vs. global), highlighting the importance of careful outcome measurement considerations in future research on PFA. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,PFA did not outperform US with regard to improvement on victims' individual psychiatric and adaptive functioning outcomes.,"['Two law enforcement agencies served as study sites', '172 crime victims (mean age = 36.4 years; 81% female']","['psychological first aid (PFA', 'PFA']","[""victims' psychiatric (i.e., symptoms of PTSD, somatization, depression, anxiety, and substance use) and adaptive functioning outcomes"", ""victims' individual psychiatric and adaptive functioning outcomes"", ""advocates' PFA adherence""]","[{'cui': 'C0162469', 'cui_str': 'Law Enforcement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0302823', 'cui_str': 'Victim of crime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}]","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.047885,PFA did not outperform US with regard to improvement on victims' individual psychiatric and adaptive functioning outcomes.,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center.'}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Zajac', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Rheingold', 'Affiliation': 'National Crime Victims Research and Treatment Center.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000588']
2830,32700953,Direct and indirect effects of a couple-focused preventive intervention on children's outcomes: A randomized controlled trial with African American families.,"OBJECTIVE


This study examined the effects of the Protecting Strong African American Families (ProSAAF) prevention program on children's outcomes more than 2 years after enrollment, including direct effects of the intervention and indirect effects through couple functioning and parent-child relations.
METHOD


Three hundred forty-six African American couples with an early adolescent child participated; all families lived in rural, low-income communities in the southern United States. Families were randomly assigned to ProSAAF or control conditions and completed four waves of data collection. Couples reported couple functioning at baseline (Wave 1) and at 9-month follow-up (Wave 2), and parent-child relations at 17-month follow-up (Wave 3). Children reported their conduct problems, affiliation with deviant peers, substance use, sexual onset, depressive symptoms, and self-control at 25-month follow-up (Wave 4).
RESULTS


Path analyses indicated significant indirect effects of ProSAAF on children's outcomes through improvements in couple functioning and better parent-child relations. There were no significant direct effects of the intervention on children's outcomes or significant indirect effects through couple functioning alone.
CONCLUSIONS


This couple-focused prevention program has positive indirect effects on several child outcomes through the intervening processes of promoting improvements in couple functioning and better parent-child relations. These findings provide cautious optimism regarding the possible benefits of couple-focused programming on participants' children while suggesting ways in which future couple-focused interventions could yield stronger effects on these youth. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Path analyses indicated significant indirect effects of ProSAAF on children's outcomes through improvements in couple functioning and better parent-child relations.","['Three hundred forty-six African American couples with an early adolescent child participated; all families lived in rural, low-income communities in the southern United States', 'African American families', ""participants' children"", ""children's outcomes""]","['ProSAAF', 'couple-focused preventive intervention', 'Protecting Strong African American Families (ProSAAF) prevention program']",['couple functioning and better parent-child relations'],"[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557130', 'cui_str': 'Lives with family'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}]",,0.0600898,"RESULTS


Path analyses indicated significant indirect effects of ProSAAF on children's outcomes through improvements in couple functioning and better parent-child relations.","[{'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Lavner', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Barton', 'Affiliation': 'Department of Human Development and Family Studies.'}, {'ForeName': 'Steven R H', 'Initials': 'SRH', 'LastName': 'Beach', 'Affiliation': 'Department of Psychology and Center for Family Research.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000589']
2831,32703614,Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: A Randomized Clinical Trial.,"OBJECTIVE


To investigate the effectiveness of strengthening the hip muscles in addition to strengthening the pelvic floor muscles (PFM) in the treatment of stress urinary incontinence.
METHODS


This study used a prospective, assessor-blind, randomized clinical trial with parallel groups. We randomly allocated 47 individuals with stress urinary incontinence to 2 groups: 1 performing only pelvic floor strengthening exercises (PF, n = 21) and the other performing pelvic floor strengthening exercises plus exercises for the gluteus maximus and medius and hip adductor muscles (PFH, n = 22). Four individuals did not complete the study. Frequency of urine leakage was the primary outcome (3-day voiding diary and a follow-up voiding diary). Secondary outcomes were pelvic floor muscle strength (Ortiz scale, PERFECT scheme [Oxford Scale], and perineometry) and quality of life (QoL; International Consultation on Incontinence Questionnaire-Short Form and King's Health Questionnaire), which were evaluated by a blinded assessor before and after 20 sessions over 10 weeks.
RESULTS


Regarding the daily frequency of urine loss evaluated by the follow-up voiding diary, an effect of group was observed (P < .001), with the PFH group showing a significant decrease in daily loss frequency, although no significant differences were found in the comparison between groups for the 3-day voiding diary, QoL, or functional assessment of the PFM.
CONCLUSION


Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.",2020,"Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.","['Stress Urinary Incontinence', '47 individuals with stress urinary incontinence to 2 groups', 'stress urinary incontinence']","['Pelvic Floor and Hip Muscle Strengthening', 'PFH', '1 performing only pelvic floor strengthening exercises (PF, n\u202f=\u202f21) and the other performing pelvic floor strengthening exercises plus exercises']","['Frequency of urine leakage', 'strength, perineometry, or QoL', 'daily loss frequency', 'frequency of daily urine loss', '3-day voiding diary, QoL, or functional assessment of the PFM', ""pelvic floor muscle strength (Ortiz scale, PERFECT scheme [Oxford Scale], and perineometry) and quality of life (QoL; International Consultation on Incontinence Questionnaire-Short Form and King's Health Questionnaire""]","[{'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",47.0,0.0646245,"Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.","[{'ForeName': 'Simone A A', 'Initials': 'SAA', 'LastName': 'Marques', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Simone R B da', 'Initials': 'SRBD', 'LastName': 'Silveira', 'Affiliation': 'Department of Obstetrics and Gynecology, Urogynecology Section, University Hospital, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anice C', 'Initials': 'AC', 'LastName': 'Pássaro', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Haddad', 'Affiliation': 'Department of Obstetrics and Gynecology, Urogynecology Section, Clinical Hospital, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': 'Department of Obstetrics and Gynecology, Urogynecology Section, University Hospital, University of São Paulo, São Paulo, Brazil; Department of Obstetrics and Gynecology, Urogynecology Section, Clinical Hospital, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elizabeth A G', 'Initials': 'EAG', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: elferreira@usp.br.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.01.007']
2832,32705319,"Effects of morphine on peri-articular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial.","PURPOSE


Peri-articular infiltration analgesia (PIA) is a widely used method to control post-operative pain in total knee arthroplasty (TKA) patients. However, there are limited data that support the use of morphine in PIA. This study aims to evaluate the efficacy of peri-articular morphine infiltration for pain management in TKA patients.
METHODS


Based on a double-blind, randomized approach, patients were allocated to the morphine or control group. Patients in the morphine group received a peri-articular infiltration of an analgesic cocktail consisting of ropivacaine, epinephrine, and morphine. Morphine was omitted from the cocktail in the control group. Primary outcomes were post-operative consumption of morphine hydrochloride used for rescue analgesia and post-operative pain as assessed by visual analog scale (VAS) score. Secondary outcomes were functional recovery as assessed by a range of knee motion, quadriceps strength, and daily ambulation distance. The duration of hospital stay was also recorded. Tertiary outcomes included the occurrence of post-operative adverse effects and the consumption of antiemetics.
RESULTS


Patients in the morphine group had significantly lower post-operative morphine consumption in the first 24 h and total morphine consumption. There was no significant difference between the two groups in post-operative VAS pain scores at rest or during motion. There was no significant difference between the two groups in the post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay. The two groups were similar in the incidence of adverse effects and the consumption of antiemetics.
CONCLUSION


Adding morphine into the analgesic cocktail of PIA could reduce postoperative morphine consumption in TKA patients, but does not improve early pain relief or accelerate functional recovery or provide clinical benefits for TKA patients. In addition, the complications and safety of peri-articular morphine infiltration need to be further investigated in larger sample studies.",2020,"There was no significant difference between the two groups in the post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay.","['total knee arthroplasty', 'TKA patients', 'pain management in TKA patients', 'total knee arthroplasty (TKA) patients']","['ropivacaine, epinephrine, and morphine', 'morphine', 'peri-articular morphine infiltration', 'Morphine', 'Peri-articular infiltration analgesia (PIA']","['occurrence of post-operative adverse effects and the consumption of antiemetics', 'adverse effects and the consumption of antiemetics', 'post-operative morphine consumption', 'post-operative consumption of morphine hydrochloride used for rescue analgesia and post-operative pain as assessed by visual analog scale (VAS) score', 'functional recovery as assessed by a range of knee motion, quadriceps strength, and daily ambulation distance', 'post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay', 'post-operative VAS pain scores', 'duration of hospital stay']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0770901', 'cui_str': 'Morphine hydrochloride'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",,0.223407,"There was no significant difference between the two groups in the post-operative knee range of motion, quadriceps strength, daily ambulation distance, or duration of post-operative hospital stay.","[{'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jikui', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""State Key Laboratory of Oral Diseases, West China School Stomatology, Sichuan University, No. 14, Third Section South Renmin Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Yunlian', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of General Surgery, Yongchuan Hospital of Traditional Chinese Medicine, 2# Yingbin Road, Yongchuan, Chongqing, 402160, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Anesthesiology, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China. hxyangjing@qq.com.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedics Surgery, West China Hospital, Sichuan University, 37# Wainan Guoxue Road, Chengdu, 610041, People's Republic of China. kangpengd@163.com.""}]",International orthopaedics,['10.1007/s00264-020-04700-z']
2833,32702298,"Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.","BACKGROUND


The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be curtailed by vaccination. We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2.
METHODS


We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 at a dose of 5 × 10 10  viral particles or MenACWY as a single intramuscular injection. A protocol amendment in two of the five sites allowed prophylactic paracetamol to be administered before vaccination. Ten participants assigned to a non-randomised, unblinded ChAdOx1 nCoV-19 prime-boost group received a two-dose schedule, with the booster vaccine administered 28 days after the first dose. Humoral responses at baseline and following vaccination were assessed using a standardised total IgG ELISA against trimeric SARS-CoV-2 spike protein, a muliplexed immunoassay, three live SARS-CoV-2 neutralisation assays (a 50% plaque reduction neutralisation assay [PRNT 50 ]; a microneutralisation assay [MNA 50 , MNA 80 , and MNA 90 ]; and Marburg VN), and a pseudovirus neutralisation assay. Cellular responses were assessed using an ex-vivo interferon-γ enzyme-linked immunospot assay. The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were done by group allocation in participants who received the vaccine. Safety was assessed over 28 days after vaccination. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. The study is ongoing, and was registered at ISRCTN, 15281137, and ClinicalTrials.gov, NCT04324606.
FINDINGS


Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05). There were no serious adverse events related to ChAdOx1 nCoV-19. In the ChAdOx1 nCoV-19 group, spike-specific T-cell responses peaked on day 14 (median 856 spot-forming cells per million peripheral blood mononuclear cells, IQR 493-1802; n=43). Anti-spike IgG responses rose by day 28 (median 157 ELISA units [EU], 96-317; n=127), and were boosted following a second dose (639 EU, 360-792; n=10). Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 . After a booster dose, all participants had neutralising activity (nine of nine in MNA 80  at day 42 and ten of ten in Marburg VN on day 56). Neutralising antibody responses correlated strongly with antibody levels measured by ELISA (R 2 =0·67 by Marburg VN; p<0·001).
INTERPRETATION


ChAdOx1 nCoV-19 showed an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme.
FUNDING


UK Research and Innovation, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and the German Center for Infection Research (DZIF), Partner site Gießen-Marburg-Langen.",2020,Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 .,"['n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised', 'Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either', 'Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms']","['ChAdOx1 nCoV-19 at a dose of 5', 'ChAdOx1 nCoV-19 vaccine against SARS-CoV-2', 'vaccine', 'ChAdOx1 nCoV-19 prime-boost group', 'chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY', 'ChAdOx1 nCoV-19']","['pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05', 'Safety', 'Safety and immunogenicity', 'spike-specific T-cell responses', 'Neutralising antibody responses', 'antibody responses', 'safety, reactogenicity, and cellular and humoral immune responses', 'Humoral responses', 'safety, reactogenicity, and immunogenicity', 'Local and systemic reactions', 'Neutralising antibody responses against SARS-CoV-2', 'neutralising activity', 'symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events']","[{'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008111', 'cui_str': 'Pan troglodytes'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687681', 'cui_str': 'Feeling feverish'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1077.0,0.295654,Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 .,"[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Belij-Rammerstorfer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': ""Vaccine Institute, St George's University, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'Department of Microbiology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Pollock', 'Affiliation': 'NIHR Imperial Clinical Research Facility, Imperial College London, London, UK.'}, {'ForeName': 'Maheshi', 'Initials': 'M', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tarrant', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: andrew.pollard@paediatrics.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31604-4']
2834,32703392,Re: Prajna et al.: Cross-Linking-Assisted Infection Reduction (CLAIR): A randomized clinical trial evaluating the effect of adjuvant cross-linking on outcomes in fungal keratitis (Ophthalmology. 2020;127:159-166).,,2020,,['fungal\xa0keratitis (Ophthalmology'],"['adjuvant cross-linking', ' Cross-Linking-Assisted Infection Reduction (CLAIR']",[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],,0.130982,,"[{'ForeName': 'Darren Shu Jeng', 'Initials': 'DSJ', 'LastName': 'Ting', 'Affiliation': ""Academic Ophthalmology, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK; Department of Ophthalmology, Queen's Medical Centre, Nottingham, UK. Electronic address: ting.darren@gmail.com.""}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Henein', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK; National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': ""Academic Ophthalmology, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK; Department of Ophthalmology, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': ""Academic Ophthalmology, Division of Clinical Neuroscience, School of Medicine, University of Nottingham, Nottingham, UK; Department of Ophthalmology, Queen's Medical Centre, Nottingham, UK.""}]",Ophthalmology,['10.1016/j.ophtha.2020.02.032']
2835,32705417,High-dose rocuronium-induced paralysis of the adductor pollicis muscle facilitates detection of the timing for tracheal intubation in elderly patients: a randomized double-blind study.,"PURPOSE


To prevent coughing related to tracheal intubation and the resultant exposure of intubating staff to the patients' expiratory aerosols, the timing of tracheal intubation needs to be precisely predicted. The aim of this study was to evaluate the hypothesis that the timing for safe tracheal intubation in elderly patients can be determined by acceleromyographically monitoring paralysis of the adductor pollicis muscle when high-dose rocuronium, given to block the respiratory muscles, is administered.
METHODS


Forty elderly (65-92 years) patients were enrolled in this study and randomly assigned to two groups, to receive rocuronium 0.6 mg/kg or 1 mg/kg. After induction of anesthesia and observing acceleromyographic train-of-four (TOF) responses of the adductor pollicis muscle to ulnar nerve stimulation, the patients randomly received either dose of rocuronium. The onset times from rocuronium administration to TOF counts of 0 were measured. Soon thereafter, a single anesthesiologist who was blinded to the allocated dose of rocuronium performed laryngoscopy and tracheal intubation, and assessed intubating conditions. Data were analyzed by the unpaired t-test and Chi-squared test.
RESULTS


The averaged [SD] onset time of neuromuscular blockade was significantly shorter with 1 mg/kg than 0.6 mg/kg rocuronium (104.3 [30.1] s vs. 186.8 [37.5] s, p < 0.001). Patients who received 0.6 mg/kg rocuronium variously showed either poor (n = 9) or good (n = 11) intubating conditions. However, all patients who received 1 mg/kg rocuronium had excellent intubating conditions.
CONCLUSIONS


If 1 mg/kg rocuronium is administered, a TOF count of 0 acceleromyographically observed at the adductor pollicis muscle can reveal the adequate timing for tracheal intubation.",2020,The averaged [SD] onset time of neuromuscular blockade was significantly shorter with 1 mg/kg than 0.6 mg/kg rocuronium (104.3 [30.1] s vs. 186.8,"['Forty elderly (65-92\xa0years', 'elderly patients']","['rocuronium', 'anesthesia and observing acceleromyographic train-of-four (TOF', 'rocuronium 0.6\xa0mg/kg or 1\xa0mg/kg', 'rocuronium performed laryngoscopy and tracheal intubation, and assessed intubating conditions']","['averaged [SD] onset time of neuromuscular blockade', 'excellent intubating conditions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",40.0,0.550908,The averaged [SD] onset time of neuromuscular blockade was significantly shorter with 1 mg/kg than 0.6 mg/kg rocuronium (104.3 [30.1] s vs. 186.8,"[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Takagi', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Sugaya', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Iwasa', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Itagaki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Seki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan. suzuki.takahiro@nihon-u.ac.jp.'}]",Journal of anesthesia,['10.1007/s00540-020-02831-6']
2836,32705460,Parent Management Training Oregon Model and Family-Based Services as Usual for Behavioral Problems in Youth: A National Randomized Controlled Trial in Denmark.,"This randomized control trial used intent-to-treat analyses to compare parent management training-Oregon model (PMTO) (N = 64) to family-based services as usual (SAU) (N = 62) in 3.5-13-year-old children and their families in Denmark. Outcomes were parent report of child internalizing and externalizing problems, parenting efficacy, parenting stress, parent sense of coherence, parent-report of life satisfaction, and parental depressive symptoms. Outcomes were measured at pretreatment, post-treatment, and 18-20 months post-treatment. Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion. Effect sizes at post-treatment and follow-up were in the small to moderate range, consistent with prior PMTO evaluations. However, there were no significant differences between PMTO and family-based SAU. Further research on the process and content of family-based SAU is needed to determine how this approach overlaps with and is distinct from PMTO.",2020,"Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion.","['Youth', 'N\u2009=\u200964) to family-based services as usual (SAU) (N\u2009=\u200962) in 3.5-13-year-old children and their families in Denmark']",['parent management training-Oregon model (PMTO'],"['child internalizing and externalizing problems, parenting efficacy, parenting stress, parent sense of coherence, parent-report of life satisfaction, and parental depressive symptoms', 'child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0611722,"Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion.","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Scavenius', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chacko', 'Affiliation': 'New York University, New York, NY, USA. anil.chacko@nyu.edu.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Lindberg', 'Affiliation': 'Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Granski', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Vardanian', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Pontoppidan', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Misja', 'Initials': 'M', 'LastName': 'Eiberg', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}]",Child psychiatry and human development,['10.1007/s10578-020-01028-y']
2837,32705473,12-Month Evaluation of an EHR-Supported Staff Role Change for Provision of Tobacco Cessation Care in 8 Primary Care Safety-Net Clinics.,"SIGNIFICANCE


Guidelines urge primary care practices to routinely provide tobacco cessation care (i.e., assess tobacco use, provide brief cessation advice, and refer to cessation support). This study evaluates the impact of a systems-based strategy to provide tobacco cessation care in eight primary care clinics serving low-income patients.
METHODS


A non-randomized stepped wedge study design was used to implement an intervention consisting of (1) changes to the electronic health record (EHR) referral functionality and (2) expansion of staff roles to provide brief advice to quit; assess readiness to quit; offer a referral to tobacco cessation counseling; and sign the referral order. Outcomes assessed from the EHR include performance of tobacco cessation care tasks, referral contact, and enrollment rates for the quitline (QL) and in-house Freedom from Smoking (FFS) program. Generalized estimating equations (GEE) methods were used to compute odds ratios contrasting the pre-implementation vs. 1-, 3-, 6-, and 12-month post-implementation periods.
RESULTS


Of the 176,061 visits, 26.1% were by identified tobacco users. All indicators significantly increased at each time period evaluated post-implementation. In comparison with the pre-intervention period, assessing smoking status (26.6% vs. 55.7%; OR = 3.7, CI = 3.6-3.9), providing advice (44.8% vs. 88.7%; OR = 7.8, CI = 6.6-9.1), assessing readiness to quit (15.8% vs. 55.0%; OR = 6.2, CI = 5.4-7.0), and acceptance of a referral to tobacco cessation counseling (0.5% vs. 30.9%; OR = 81.0, CI = 11.4-575.8) remained significantly higher 12 months post-intervention. For the QL and FFS, respectively, there were 1223 and 532 referrals; 324 (31.1%) and 103 (24.7%) were contacted; 241 (74.4%) and 72 (69.6%) enrolled; and 195 (80.9%) and 14 (19.4%) received at least one counseling session.
CONCLUSIONS


This system change intervention that includes an EHR-supported role expansion substantially increased the provision of tobacco cessation care and improvements were sustained beyond 1 year. This approach has the potential to greatly increase the number of individuals referred for tobacco cessation counseling.",2020,This system change intervention that includes an EHR-supported role expansion substantially increased the provision of tobacco cessation care and improvements were sustained beyond 1 year.,['eight primary care clinics serving low-income patients'],"['systems-based strategy to provide tobacco cessation care', 'EHR-Supported Staff Role Change for Provision of Tobacco Cessation Care', 'electronic health record (EHR) referral functionality and (2) expansion of staff roles to provide brief advice to quit; assess readiness to quit']","['assessing readiness to quit', 'acceptance of a referral to tobacco cessation counseling', 'smoking status', 'EHR include performance of tobacco cessation care tasks, referral contact, and enrollment rates for the quitline (QL) and in-house Freedom from Smoking (FFS) program']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0237102', 'cui_str': 'Role change'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",,0.075455,This system change intervention that includes an EHR-supported role expansion substantially increased the provision of tobacco cessation care and improvements were sustained beyond 1 year.,"[{'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Flocke', 'Affiliation': 'Department of Family Medicine, Oregon Health & Science University, Portland, OR, USA. flocke@ohsu.edu.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Seeholzer', 'Affiliation': 'Center for Health Care Research and Policy, The MetroHealth System, Cleveland, OH, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lewis', 'Affiliation': 'Center for Health Care Research and Policy, The MetroHealth System, Cleveland, OH, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Gill', 'Affiliation': 'Center for Community Health Integration, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Jeanmarie C', 'Initials': 'JC', 'LastName': 'Rose', 'Affiliation': 'Center for Community Health Integration, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Albert', 'Affiliation': 'Center for Community Health Integration, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Love', 'Affiliation': 'Center for Health Care Research and Policy, The MetroHealth System, Cleveland, OH, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaelber', 'Affiliation': 'Center for Health Care Research and Policy, The MetroHealth System, Cleveland, OH, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06030-7']
2838,32709514,The Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Patients With Low Back Pain: A Randomized Control Trial.,"OBJECTIVE


To investigate the immediate changes in resting and contracted thickness of the transversus abdominis (TrA) muscle after application of thrust joint manipulation (TJM) vs sham manipulation in participants with low back pain.
METHODS


A pretest-posttest randomized controlled trial design was performed. Consecutive subjects satisfying eligibility criteria completed patient-report outcome baseline measures, pretreatment rehabilitative ultrasound imaging (RUSI) measurements, followed by the randomly assigned intervention then, post-treatment RUSI measurements, and post-treatment & final patient-reported outcome measures. To compare the outcomes of TJM and sham manipulation on the TrA muscle thickness, a 2-by-2 analysis of variance (treatment [TJM and sham manipulation]) by time (pretreatment and post-treatment) was completed for both the TrA muscle thickness at rest and muscle thickness during contraction. Descriptive statistics including independent-sample t tests for continuous variables and χ 2  tests for categorical variables were used to analyze differences in patient-reported outcome measures between groups.
RESULTS


Sixty-seven eligible participants agreed to participate. No significant interactions were identified for either muscle thickness at rest or contraction.
CONCLUSION


This study did not support the hypothesis that manipulation would result in greater changes in TrA thickness at rest or during contraction in participants with low back pain. Based on prior research that identified subgroups of participants likely to respond to manipulation, future research should include participants more likely to respond favorably to TJM. This study was a priori registered with clinicaltrails.gov (NCT02558855).",2020,"No significant interactions were identified for either muscle thickness at rest or contraction.
","['participants with low back pain', 'Patients With Low Back Pain', 'Sixty-seven eligible participants agreed to participate']","['TJM and sham manipulation', 'transversus abdominis (TrA) muscle after application of thrust joint manipulation (TJM) vs sham manipulation', 'Thrust Joint Manipulation']",['TrA thickness'],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C0556783', 'cui_str': 'Manipulation of joint - non-surgical'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}]",67.0,0.123283,"No significant interactions were identified for either muscle thickness at rest or contraction.
","[{'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Fosberg', 'Affiliation': 'Nova Southeastern University, Fort Lauderdale, FL; DeRosa Physical Therapy, Flagstaff, AZ. Electronic address: fosbergk@summitctr.net.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Puentedura', 'Affiliation': 'School of Allied Health Sciences Department, University of Las Vegas Nevada, Las Vegas, NV.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Schmitz', 'Affiliation': 'DeRosa Physical Therapy, Flagstaff, AZ.'}, {'ForeName': 'Tarang K', 'Initials': 'TK', 'LastName': 'Jain', 'Affiliation': 'Department of Physical Therapy, Northern Arizona University, Flagstaff, AZ.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Franklin Pierce University, Manchester, NH.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.04.006']
2839,32706731,Validation of a Mobile Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form: An Observational Randomized Crossover Trial.,"BACKGROUND


The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire is an effective tool for evaluating shoulder joint function. The development and usage of a mobile version of the ASES questionnaire has the potential to save time, money, and effort.
OBJECTIVE


The aim of this study is to assess the equivalence between the paper and mobile versions of the ASES questionnaire and their acceptability among patients.
METHODS


The paper and mobile versions of the ASES questionnaire were used to evaluate the shoulder joint function of 50 patients with shoulder pain. This study included patients from the shoulder clinic of Sun Yat-sen Memorial Hospital. The intraclass correlation coefficient (ICC) and Bland-Altman method were used to evaluate the agreement (reliability) of the scores obtained by the two methods (paper versus mobile).
RESULTS


Of the 50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study. There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001). The mean difference between the scores of the mobile and paper versions was 1.0, and only 1/46 (2%) had a difference greater than the minimal clinically important difference of 12 points. About 75% of patients preferred the mobile version to the paper version.
CONCLUSIONS


Our study shows that the mobile version of the ASES questionnaire is comparable to the paper version, and has a higher patient preference. This could prove to be a useful tool for epidemiological studies and patient follow-up over longer periods of time.",2020,"There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001).","['American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form', '50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study', '50 patients with shoulder pain', 'patients', 'patients from the shoulder clinic of Sun Yat-sen Memorial Hospital']",['Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire'],[],"[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],50.0,0.0611349,"There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001).","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qingyue', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Menglei', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fangqi', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yiyong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yamuhanmode', 'Initials': 'Y', 'LastName': 'Alike', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanhao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Maslah Idiris', 'Initials': 'MI', 'LastName': 'Ali', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Congda', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.'}]",JMIR mHealth and uHealth,['10.2196/16758']
2840,32706734,Acceptability of an Embodied Conversational Agent for Type 2 Diabetes Self-Management Education and Support via a Smartphone App: Mixed Methods Study.,"BACKGROUND


Embodied conversational agents (ECAs) are increasingly used in health care apps; however, their acceptability in type 2 diabetes (T2D) self-management apps has not yet been investigated.
OBJECTIVE


This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
METHODS


A sequential mixed methods design was applied. Adults with T2D allocated to the intervention arm of the MDC trial used the MDC app over a period of 12 months. At 6 months, they completed questions assessing their interaction with, and attitudes toward, the ECA. In-depth qualitative interviews were conducted with a subsample of the participants from the intervention arm to explore their experiences of using the ECA. The interview questions included the participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character. The quantitative and qualitative data were interpreted using integrated synthesis.
RESULTS


Of the 93 intervention participants, 44 (47%) were women; the mean (SD) age of the participants was 55 (SD 10) years and the baseline glycated hemoglobin A1c level was 7.3% (SD 1.5%). Overall, 66 of the 93 participants (71%) provided survey responses. Of these, most described Laura as being helpful (57/66, 86%), friendly (57/66, 86%), competent (56/66, 85%), trustworthy (48/66, 73%), and likable (40/66, 61%). Some described Laura as not real (18/66, 27%), boring (26/66, 39%), and annoying (20/66, 30%). Participants reported that interacting with Laura made them feel more motivated (29/66, 44%), comfortable (24/66, 36%), confident (14/66, 21%), happy (11/66, 17%), and hopeful (8/66, 12%). Furthermore, 20% (13/66) of the participants were frustrated by their interaction with Laura, and 17% (11/66) of the participants reported that interacting with Laura made them feel guilty. A total of 4 themes emerged from the qualitative data (N=19): (1) perceived role: a friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions.
CONCLUSIONS


These findings suggest that an ECA is an acceptable means to deliver T2D self-management education and support. A human-like character providing ongoing, friendly, nonjudgmental, emotional, and motivational support is well received. Nevertheless, the ECA can be improved by increasing congruence between its verbal and nonverbal communication and accommodating user preferences.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry CTRN12614001229662; https://tinyurl.com/yxshn6pd.",2020,"This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
","['Adults with T2D', ""participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character""]","['Embodied Conversational Agent', 'Embodied conversational agents (ECAs', 'ECA (Laura', ""friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions"", 'ECA']","['survey responses', 'baseline glycated hemoglobin A1c level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007952', 'cui_str': 'Character'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",93.0,0.0433844,"This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
","[{'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Baptista', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wadley', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bird', 'Affiliation': 'The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""see Authors' Contributions, .""}]",JMIR mHealth and uHealth,['10.2196/17038']
2841,32715995,Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial.,"AIMS


In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial.
METHODS AND RESULTS


A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males.
CONCLUSIONS


Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI.
CLINICAL TRIAL REGISTRATION


http://clinicaltrials.gov NCT01586910.",2020,"All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs. 10.5%, p=0.90) and males (14.5% vs. 14.4%, p=0.99); the difference between females and males was 10.2% vs. 14.5%, for TAVI (p=0.08) and 10.5% vs. 14.4%, SAVR (p=0.13).","['Men and Women with Aortic Stenosis at Intermediate Operative Risk', 'males and females at intermediate surgical risk', 'patients with aortic stenosis', '1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR']","['transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR', 'TAVI or SAVR']","['Thoracic Surgeons score', 'composite of all-cause mortality or disabling stroke', 'mortality or disabling stroke', 'Functional status improvement', 'concomitant revascularization']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1660.0,0.0296006,"All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs. 10.5%, p=0.90) and males (14.5% vs. 14.4%, p=0.99); the difference between females and males was 10.2% vs. 14.5%, for TAVI (p=0.08) and 10.5% vs. 14.4%, SAVR (p=0.13).","[{'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': ''}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heiser', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Merhi', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fail', 'Affiliation': ''}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': ''}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stoler', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hebeler', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00303']
2842,32706285,Effectiveness of Bath Wipes After Hematopoietic Cell Transplantation: A Randomized Trial.,"Objective:  Bacteremia is a leading cause of morbidity and mortality in children undergoing hematopoietic cell transplantation (HCT). Infections of vancomycin-resistant enterococci (VRE) and multidrug resistant (MDR) gram-negative rods (GNRs) are common in this population. Our objective was to assess whether experimental bath wipes containing silver were more effective than standard bath wipes containing soap at reducing skin colonization by VRE and MDR GNRs, and nonmucosal barrier injury bacteremia.  Study Design:  Patients undergoing autologous or allogeneic HCT in a tertiary referral center were randomized to receive experimental or standard bath wipes for 60 days post-HCT. Skin swabs were collected at baseline, discharge, and day +60 post-HCT. The rate of VRE colonization was chosen as the marker for efficacy.  Results:  Experimental bath wipes were well tolerated. Before the study, the rate of colonization with VRE in HCT recipients was 25%. In an interim analysis of 127 children, one (2%) patient in the experimental arm and two (3%) in the standard arm were colonized with VRE. Two (3%) patients had nonmucosal barrier injury bacteremia in the standard arm, with none in the experimental arm. MDR GNRs were not isolated. The trial was halted because the interim analyses indicated equivalent efficacy of the two methods.  Conclusions:  Skin cleansing with silver-containing or standard bath wipes resulted in very low and equivalent rates of bacteremia and colonization with VRE and MDR GNRs in children post-HCT. Future studies in other high-risk populations are needed to confirm these results.",2020,"Our objective was to assess whether experimental bath wipes containing silver were more effective than standard bath wipes containing soap at reducing skin colonization by VRE and MDR GNRs, and nonmucosal barrier injury bacteremia.  ","['After Hematopoietic Cell Transplantation', 'children undergoing hematopoietic cell transplantation (HCT', 'Patients undergoing autologous or allogeneic HCT in a tertiary referral center']","['Bath Wipes', 'vancomycin-resistant enterococci (VRE) and multidrug resistant (MDR) gram-negative rods (GNRs', 'Skin cleansing with silver-containing or standard bath wipes', 'experimental or standard bath wipes for 60 days post-HCT']","['rate of colonization with VRE', 'nonmucosal barrier injury bacteremia', 'rate of VRE colonization', 'tolerated']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0314752', 'cui_str': 'Gram-negative bacillus'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",127.0,0.12009,"Our objective was to assess whether experimental bath wipes containing silver were more effective than standard bath wipes containing soap at reducing skin colonization by VRE and MDR GNRs, and nonmucosal barrier injury bacteremia.  ","[{'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Kjellin', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Qudeimat', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Browne', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Keerthi', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Sunkara', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Guolian', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Winfield', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Giannini', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Maron', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Hayden', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Wing', 'Initials': 'W', 'LastName': 'Leung', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Triplett', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Srinivasan', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}]",Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses,['10.1177/1043454220944061']
2843,32707476,Sales to apparently alcohol-intoxicated customers and online responsible vendor training in recreational cannabis stores in a randomized trial.,"BACKGROUND


In some U.S. states, laws prohibit sales of recreational marijuana to intoxicated customers to prevent associated harms. In alcohol markets, training in responsible sales practices is one intervention to help reduce such sales to intoxicated customers. Similar training may be beneficial in the recreational cannabis market.
METHODS


An online responsible marijuana vendor (RMV) training was developed. Among its five modules, learning elements taught store personnel to recognize signs of alcohol impairment and intoxication, refuse sales, and understand the risks of driving under the influence of cannabis. A sample of n = 150 recreational cannabis stores in Colorado, Oregon, and Washington State, USA were enrolled in a randomized controlled trial, half of which were randomly assigned to use the RMV training. Stores were posttested using a pseudo-customer protocol in which confederate buyers feigned obvious signs of alcohol intoxication.
RESULTS


Deterrence of sales to intoxicated customers does not seem to exist, regardless of whether the states' laws prohibit it. Only 16 of 146 stores (11.0%; 4 Oregon stores were eliminated that were not in business) refused sales. There was no difference in refusal rates between intervention (11.6% [3.9%]) and control stores (7.6% [3.1%], F = 0.71, p = 0.401 [1-tailed]) or between stores that used the RMV training (6.3% [4.0%]) or not (12.0% [5.7%], F = 0.91, p = 0.343 [2-tailed]). In 11 visits, store personnel commented on the buyers' behavior, or expressed concern/suspicion about buyers, but sold to them anyway.
CONCLUSIONS


Training in responsible sales practices alone did not appear to reduce sales to apparently alcohol-intoxicated customers. Legal deterrence from making these sales may be insufficient or nonexistent for store management to support adherence to this responsible sales practice. Regulatory and policy actions may be needed to increase perceived risk with such sales (i.e., clear policy and swift, severe, and certain penalties) to achieve training's benefits.",2020,"There was no difference in refusal rates between intervention (11.6% [3.9%]) and control stores (7.6% [3.1%], F = 0.71, p = 0.401","['A sample of n\xa0=\xa0150 recreational cannabis stores in Colorado, Oregon, and Washington State, USA']","['RMV training', 'alcohol-intoxicated customers and online responsible vendor training']","['control stores', 'refusal rates']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0042462', 'cui_str': 'Vendors'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}]",150.0,0.027768,"There was no difference in refusal rates between intervention (11.6% [3.9%]) and control stores (7.6% [3.1%], F = 0.71, p = 0.401","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'W Gill', 'Initials': 'WG', 'LastName': 'Woodall', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Saltz', 'Affiliation': 'Prevention Research Center, 2150 Shattuck, Avenue, Suite 601, Berkeley, CA 94704, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grayson', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Sierra', 'Initials': 'S', 'LastName': 'Svendsen', 'Affiliation': 'Klein Buendel, Inc., 1667 Cole Boulevard, Suite 225, Golden, CO 80401, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama, 403b Ryals Public Health Building 1665 University Boulevard, Birmingham, AL 35294, USA.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102860']
2844,32715153,A community-based positive psychology group intervention to promote physical activity among people with metabolic syndrome: Proof of concept results to inform a pilot randomized controlled trial protocol.,"Background


Community-based physical activity interventions can offset the burden of developing chronic diseases. Positive psychology (PP) interventions may improve health behaviors, but little is known about their effectiveness in community-based prevention settings. A multilevel PP-based intervention has never been studied in people at risk for chronic diseases.
Purpose


The aim of the trial is to demonstrate feasibility, acceptability, and improve physical activity. The purpose is to describe the theory, design, and rationale of the randomized controlled trial (RCT) phase of an iteratively developed physical activity intervention for metabolic syndrome. The feasibility results of the proof-of-concept phase are presented.
Methods


Participants are adult primary care patients at community health centers with metabolic syndrome and low physical activity (target n = 64). The 8-week group intervention consists of weekly physical activity goal-setting and self-monitoring, positive psychology activities, and neighborhood walks. Participants rate feasibility and acceptability of sessions. Pre-post-intervention, and 24 weeks later, participants complete accelerometers, questionnaires, and biometrics.
Feasibility results


Eight participants enrolled and seven completed. The median number of group sessions attended was 7 out of 8. Average ease and usefulness of sessions were rated as 7.0 (±0.5)/10 and 8.1 (±1.0)/10, respectively, indicating feasibility and acceptability. Average pre-post physical activity increased by 2152 steps and 29.25 min of MVPA/week.
Discussion


This proof-of-concept trial demonstrated high feasibility and acceptability, with increased physical activity. These positive findings suggest that the RCT phase will show high feasibility, acceptability, and initial impact on physical activity.",2020,"Average pre-post physical activity increased by 2152 steps and 29.25 min of MVPA/week.
","['Methods\n\n\nParticipants are adult primary care patients at community health centers with metabolic syndrome and low physical activity (target n\xa0=\xa064', 'Eight participants enrolled and seven completed', 'people with metabolic syndrome', 'metabolic syndrome']","['physical activity intervention', 'Positive psychology (PP) interventions', 'community-based positive psychology group intervention', '\n\n\nCommunity-based physical activity interventions', 'weekly physical activity goal-setting and self-monitoring, positive psychology activities, and neighborhood walks']","['feasibility and acceptability', 'Average pre-post physical activity', 'health behaviors']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",8.0,0.0614831,"Average pre-post physical activity increased by 2152 steps and 29.25 min of MVPA/week.
","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, United States.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, United States.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, United States.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, United States.'}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, United States.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100626']
2845,32706738,User Engagement Among Diverse Adults in a 12-Month Text Message-Delivered Diabetes Support Intervention: Results from a Randomized Controlled Trial.,"BACKGROUND


Text message-delivered interventions are a feasible and scalable approach for improving chronic disease self-care and reducing health disparities; however, information on long-term user engagement with these interventions is limited.
OBJECTIVE


The aim of this study is to examine user engagement in a 12-month text message-delivered intervention supporting diabetes self-care, called REACH (Rapid Education/Encouragement And Communications for Health), among racially and socioeconomically diverse patients with type 2 diabetes (T2D). We explored time trends in engagement, associations between patient characteristics and engagement, and whether the addition of a human component or allowing patients to change their text frequency affected engagement. Qualitative data informed patients' subjective experience of their engagement.
METHODS


We recruited patients with T2D for a randomized trial evaluating mobile phone support relative to enhanced treatment as usual. This analysis was limited to participants assigned to the intervention. Participants completed a survey and hemoglobin A1c (HbA1c) test and received REACH text messages, including self-care promotion texts, interactive texts asking about medication adherence, and adherence feedback texts. For the first 6 months, texts were sent daily, and half of the participants also received monthly phone coaching. After 6 months, coaching stopped, and participants had the option to receive fewer texts for the subsequent 6 months. We defined engagement via responses to the interactive texts and responses to a follow-up interview. We used regression models to analyze associations with response rate and thematic and structural analysis to understand participants' reasons for responding to the texts and their preferred text frequency.
RESULTS


The participants were, on average, aged 55.8 (SD 9.8) years, 55.2% (137/248) female, and 52.0% (129/248) non-White; 40.7% (101/248) had ≤ a high school education, and 40.7% (101/248) had an annual household income <US $25,000. The median response rate to interactive texts was 91% (IQR 75%-97%) over 12 months. Engagement gradually declined throughout the intervention but remained high. Engagement did not differ by age, gender, education, income, diabetes duration, insulin status, health literacy, or numeracy. Black race and worse baseline medication adherence and HbA1c were each associated with lower engagement, although the effects were small. Nearly half of the participants chose to continue receiving daily texts for the last 6 months of the intervention. Participants who continued daily text messages said they wanted to continue experiencing benefits to their health, whereas those who chose fewer texts said that the daily texts had helped them create routines and they no longer needed them as often. Engagement was not impacted by receiving coaching or by participants' chosen text frequency.
CONCLUSIONS


Well-designed interactive text messages can engage diverse patients in a self-care intervention for at least 1 year. Variation in and reasons for frequency preference suggest that offering a frequency choice may be important to users' engagement.",2020,"Black race and worse baseline medication adherence and HbA1c were each associated with lower engagement, although the effects were small.","['participants were, on average, aged 55.8 (SD 9.8) years, 55.2% (137/248) female, and 52.0% (129/248) non-White; 40.7% (101/248) had ≤ a high school education, and 40.7% (101/248) had an annual household income', 'racially and socioeconomically diverse patients with type 2 diabetes (T2D']","['monthly phone coaching', 'Text Message-Delivered Diabetes Support Intervention', 'REACH text messages, including self-care promotion texts, interactive texts asking about medication adherence, and adherence feedback texts', 'text message-delivered intervention supporting diabetes self-care, called REACH (Rapid Education/Encouragement And Communications for Health']","['median response rate to interactive texts', 'age, gender, education, income, diabetes duration, insulin status, health literacy, or numeracy']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",,0.0979734,"Black race and worse baseline medication adherence and HbA1c were each associated with lower engagement, although the effects were small.","[{'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spieker', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greevy', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'LeStourgeon', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Wallston', 'Affiliation': 'Institute for Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Mayberry', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.'}]",JMIR mHealth and uHealth,['10.2196/17534']
2846,32707403,"Changes to stance limb peak, cumulative, and regional plantar foot forces among normal walking and three mobility aids in healthy older adults.","BACKGROUND


Mobility aids are commonly prescribed to offload an injured lower extremity. Device selection may impact stance foot loading patterns and foot health in clinical populations at risk of foot ulceration.
RESEARCH QUESTIONS


Two questions motivated this study: How does device selection influence peak plantar and regional (rearfoot, mid foot and forefoot) foot forces on the stance foot? Does device selection influence peak, cumulative, and regional plantar forces within a 200 m walking trial?
METHODS


Twenty-one older adults walked 200 m at self-selected pace in four randomized conditions for this prospective crossover study. Participants used a walker, crutches, wheeled knee walker (WKW), and no assistive device (control condition). Plantar forces were measured using a wireless in-shoe system (Loadsol, Novel Inc., St. Paul, MN). Repeated measures analyses of variance were used to determine differences in peak and cumulative total and regional forces among walking conditions. Paired sample t-tests compared forces during first and last 30 s epochs of each condition to determine device influence over time.
RESULTS


The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions. Crutch use had similar peak forces as control. There were no differences in the number of steps taken within devices comparing first and last epochs. Crutches had a 0.04 and 0.07 BW increase in peak net and forefoot forces during the last epoch. Walker use had 66.44 BW lower cumulative forefoot forces in the last epoch.
SIGNIFICANCE


Crutches had similar stance foot loading as normal walking while a walker lowered forefoot forces at the expense of increased steps. A WKW may be the best choice to 'protect' tissues in the stance foot from exposure to peak and cumulative forces in the forefoot region.",2020,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"['healthy older adults', 'Twenty-one older adults walked 200 m at self-selected pace']",['normal walking and three mobility aids'],"['device selection influence peak, cumulative, and regional plantar forces', 'peak net forces', 'Plantar forces', 'peak net and forefoot forces', 'stance limb peak, cumulative, and regional plantar foot forces', 'peak and cumulative total and regional forces among walking conditions', 'cumulative forefoot forces']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3495449', 'cui_str': 'Mobility aid'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",21.0,0.0456241,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kingston', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada. Electronic address: david.kingston@usask.ca.'}, {'ForeName': 'A Gary', 'Initials': 'AG', 'LastName': 'Linassi', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada; School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: anl931@mail.usask.ca.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Zucker-Levin', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: audrey.zuckerlevin@usask.ca.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.015']
2847,32716206,Effects on Suxiao Jiuxin Pills in the Treatment of Patients with Acute Coronary Syndrome Undergoing Early Percutaneous Coronary Intervention: A Multicenter Randomized Double-Blind Placebo-Controlled Trial.,"Objectives:  Acute coronary syndrome (ACS) is an acute disease with high mortality. Although early percutaneous coronary intervention (PCI) is proved to be the practical approach in treating ACS, the incidence of cardiovascular events is still far from satisfactory. The combination of Suxiao Jiuxin Pill (SJP) and Western medicine is one conventional approach in the treatment of ACS. Many elementary and clinical trials have proved the efficacy and safety in the improvement of cardiocerebral vascular conditions. The aim of this project is to evaluate the safety and efficacy of SJP on ACS with early PCI patients.  Trial Design:  This is a multicenter randomized, double-blind placebo-controlled trial. Trial registration: ChiCTR-TRC-13003053.  Settings:  Hospitals.  Subjects:  A total of 200 ACS with early PCI patients were randomly divided into SJP group ( n  = 100) and placebo group ( n  = 100).  Interventions:  The SJP group was treated with routine treatment and SJP (taking eight SJP pills orally each time, three times per day). The placebo group was treated with routine treatment along with equal amounts of SJP placebo. The course of treatment was 6 months and a follow-up visit at 12 months.  Outcome Measures:  Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC).  Results:  The SJP group had a relatively low incidence of MACE than the placebo ( p  < 0.05, odds ratio: 1.916, 95% confidence interval [0.999-3.674]). LVEF was significantly higher in the SJP group than the placebo group on the 360-day follow-up ( p  < 0.01). SJP had a significant increase score in the SAQ subscale of physical limitation, angina frequency, and treatment satisfaction ( p  < 0.05). There is no significant difference in the cTNI and CRP level between the two groups. The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo ( p  < 0.05). The numbers of adverse events between the two groups were not statistically different ( p  > 0.05).  Conclusions:  SJP is associated with a reduction in MACE, and an improvement of heart function and quality of life in ACS patients with early PCI, and is probably safe to use.",2020,The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo ( p  < 0.05).,"['Undergoing Early Percutaneous Coronary Intervention', 'Patients with Acute Coronary Syndrome', 'ACS patients with early PCI', 'early PCI patients', 'Subjects:  A total of 200 ACS with early PCI patients']","['Suxiao Jiuxin Pill (SJP) and Western medicine', 'percutaneous coronary intervention (PCI', 'Suxiao Jiuxin Pills', 'Placebo', 'routine treatment and SJP', 'SJP', 'SJP placebo', 'placebo']","['LVEF', 'cTNI and CRP level', 'SAQ subscale of physical limitation, angina frequency, and treatment satisfaction', 'numbers of adverse events', 'heart function and quality of life', 'safety and efficacy', 'serum concentration of Fib and cysC in the SJP', 'Outcome Measures:  Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0050133', 'cui_str': '9,10-anthraquinone'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0077400', 'cui_str': 'Troponin C'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}]",200.0,0.258197,The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo ( p  < 0.05).,"[{'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Tiejun', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Hua', 'Affiliation': 'Department of Cardiology, Zhejiang Province Hospital of Traditional Chinese Medicine, Zhejiang, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Guangdong Province Hospital of Traditional Chinese Medicine, Guangdong, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0014']
2848,32711916,Understanding randomized trial design in vascular surgery.,,2020,,[],[],[],[],[],[],,0.145349,,"[{'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'McClure', 'Affiliation': 'Division of Vascular Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Whitlock', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada; Division of Cardiac Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Emilie P', 'Initials': 'EP', 'LastName': 'Belley-Cote', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Université de Sherbrooke, Québec, Canada.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.04.013']
2849,32706953,Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.,"BACKGROUND


Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
METHODS


We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
RESULTS


A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
CONCLUSIONS


Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).",2020,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","['hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen', 'Mild-to-Moderate Covid-19', 'patients with coronavirus disease 2019 (Covid-19', 'patients hospitalized with mild-to-moderate Covid-19', '667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis']","['Hydroxychloroquine and azithromycin', 'hydroxychloroquine', 'hydroxychloroquine plus azithromycin', 'Hydroxychloroquine with or without Azithromycin', 'azithromycin', 'standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine']","['safety and efficacy', 'Safety', 'Prolongation of the corrected QT interval and elevation of liver-enzyme levels', 'clinical status at 15 days as assessed with the use of a seven-level ordinal scale']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",667.0,0.251782,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","[{'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Debora L M', 'Initials': 'DLM', 'LastName': 'Junqueira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tramujas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Erlon O', 'Initials': 'EO', 'LastName': 'Abreu-Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ligia N', 'Initials': 'LN', 'LastName': 'Laranjeira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline T', 'Initials': 'AT', 'LastName': 'Soares', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Leandro S', 'Initials': 'LS', 'LastName': 'Echenique', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otávio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Golin', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fábio F', 'Initials': 'FF', 'LastName': 'Cardoso', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann Filho', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adrian P M', 'Initials': 'APM', 'LastName': 'Kormann', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Monalisa F', 'Initials': 'MF', 'LastName': 'Bocchi de Oliveira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa-Neto', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019014']
2850,32713421,CPAP titration failure is not equivalent to long-term CPAP treatment failure in patients with obesity hypoventilation syndrome: a case series.,"STUDY OBJECTIVES


Medium and long-term trials comparing continuous positive airway pressure (CPAP) with noninvasive ventilation in patients with obesity hypoventilation syndrome have shown no differences in outcomes. However, it remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events or if maximum CPAP pressure is reached. We aimed to examine the effects of 6 weeks of home CPAP therapy on gas exchange in patients with obesity hypoventilation syndrome who failed CPAP titration due to persistent hypoxemia.
METHODS


This case series is a substudy of a randomized-controlled trial evaluating efficacy of 3 different PAP modalities in obesity hypoventilation syndrome. Patients randomized to CPAP who failed titration and were prescribed CPAP are included. CPAP failure was defined as spending more than 20% of total sleep time with oxygen saturation below 90% despite adequate resolution of apneas and hypopneas. Follow-up data included in-laboratory polysomnogram on prescribed CPAP after 6 weeks of home CPAP therapy.
RESULTS


Three of seven participants (43%) randomized to CPAP failed CPAP titration. All were morbidly obese, had severe OSA (apnea-hypopnea index > 90 events/h) and severe sleep hypoxemia (percentage of total sleep time with oxygen saturation < 90% [T90] = 60-89%). Hypoxemia (T90: 43-67%, T80: 0-31%, and T70: 0-11%) and hypercapnia (transcutaneous pressure of CO₂ levels > 50 mm Hg) persisted during CPAP titration polysomnogram. The final polysomnogram after 6 weeks of adherent home CPAP therapy showed effective control of obstructive sleep apnea. Hypoventilation and hypoxemia severity decreased significantly in all 3 participants.
CONCLUSIONS


Our data suggest that CPAP titration failure does not equal CPAP treatment failure.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: AVAPS-AE Efficacy Study; URL: https://clinicaltrials.gov/ct2/show/NCT01368614; Identifier: NCT01368614.",2020,"Hypoventilation and hypoxemia severity decreased significantly in all three participants.
","['patients with OHS who failed CPAP titration due to persistent hypoxemia', 'All were morbidly obese, had severe OSA (AHI >90/h) and severe sleep hypoxemia (percentage of total sleep time with oxygen saturation <90% [T90] = 60-89', 'patients with obesity hypoventilation syndrome (OHS', 'patients with obesity hypoventilation syndrome']","['CPAP with noninvasive ventilation', 'CPAP', 'hypercapnia ', 'home CPAP therapy']","['CPAP failure', 'transcutaneous pCO₂ levels ', 'Hypoventilation and hypoxemia severity', 'Hypoxemia', 'effective control of OSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031880', 'cui_str': 'Extreme obesity with alveolar hypoventilation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0439087', 'cui_str': '<90'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",7.0,0.113595,"Hypoventilation and hypoxemia severity decreased significantly in all three participants.
","[{'ForeName': 'Alejandra C', 'Initials': 'AC', 'LastName': 'Lastra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Section of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, Illinois.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8712']
2851,32715151,Assessing the impact of Social Networking Site use on older people's loneliness and social isolation. A randomized controlled trial: The Aging in a Networked Society-Social Experiment Study (ANS-SE).,"Introduction


An ageing society poses unprecedented challenges to societies. Information and Communication Technologies (ICTs), including Social Networking Sites (SNSs), may contribute to contrast loneliness and social isolation in old age. Despite of the potentialities of SNSs, there is only a handful of studies assessing the causal relationship of SNS use and older people's well-being. This paper aims to provide further evidence on the design of randomised controlled trials exploring the causal impact of SNS use on loneliness and social isolation in old age.
Methods and analysis


The Aging in a Networked Society-Social Experiment Study (ANS-SE) is a randomised controlled trial conducted on people aged 75 and over residing in a town located in the Milan area (Italy) aiming to assess the impact of SNS use on loneliness and social isolation (i.e. the primary outcomes of this study). The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into one treatment group and two control groups; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (C1). The inactive control group (C) is constituted of a waiting list. We will perform bivariate and regression analysis.
Ethics and dissemination


The study has been approved by the Ethic Committee of the University of Milano Bicocca (prot. 431/2019) and was registered at Clinical Trials.gov (NCT04242628). Written consent was obtained from all respondents. Results from the study will be discussed with the local community and stakeholders, presented in national and international conferences and published in leading peer-review journals. The consent forms, the anonymised dataset, and the relevant statistical codes will be deposited with the Italian Unidata archive, also in charge of releasing the data to the public, upon a short embargo period.",2020,The experiment is structured into one treatment group and two control groups; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (C1).,"['people aged 75 and over residing in a town located in the Milan area (Italy', ""older people's loneliness and social isolation""]",['SNS'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}]",[],,0.0397034,The experiment is structured into one treatment group and two control groups; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (C1).,"[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Zaccaria', 'Affiliation': 'University of Applied Sciences and Arts of Southern Switzerland, Department of Business Economics, Health and Social Care, Centre of Competence on Ageing, Manno, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Guaita', 'Affiliation': 'Golgi Cenci Foundation, Abbiategrasso, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Vaccaro', 'Affiliation': 'Golgi Cenci Foundation, Abbiategrasso, Italy.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Casanova', 'Affiliation': 'IRCCS-INRCA-National Institute of Health & Science on Ageing, Centre for Socio-Economic Research on Ageing, Ancona, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Abbondanza', 'Affiliation': 'Golgi Cenci Foundation, Abbiategrasso, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pettinato', 'Affiliation': 'University of Milan Bicocca, Department of Sociology and Social Research, Milan, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Cerati', 'Affiliation': 'Golgi Cenci Foundation, Abbiategrasso, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Rolandi', 'Affiliation': 'Golgi Cenci Foundation, Abbiategrasso, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Sala', 'Affiliation': 'University of Milan Bicocca, Department of Sociology and Social Research, Milan, Italy.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100615']
2852,32716303,Evaluating the Effects of a Mobile Health App on Reducing Patient Care Needs and Improving Quality of Life After Oral Cancer Surgery: Quasiexperimental Study.,"BACKGROUND


Intervention with a mobile Health (mHealth) app can improve the efficacy of early detection of oral cancer and the outcomes for patients taking oral anticancer medications. The quality of life of oral cancer patients is significantly reduced within three months after surgery; also, their needs for nursing care and health information increase, mainly due to side effects and associated psychological problems.
OBJECTIVE


This study aimed to evaluate changes in the care needs and quality of life of patients with oral cancer after receiving the intervention of a newly developed mHealth app.
METHODS


After surgery, oral cancer patients were divided into an experimental group (n=50) who received the mHealth app intervention and a control group (n=50) who received routine health care and instruction. After 3 months of intervention, survey questionnaires were used to assess the patients' quality of life, nursing care needs, and acceptance of the mHealth app.
RESULTS


The physiological care needs were significantly decreased in the experimental group compared with the control group (P<.05). Although the differences were not statistically significant, the psychological needs, communication needs, and care support needs all improved after the mHealth app intervention. The overall improvement in quality of life was higher in the experimental group than in the control group (-7.24 vs -4.36). In terms of intention to use, perceived usefulness, and perceived ease of use, the acceptability scores of the mHealth app were significantly increased after 3 months of intervention (P<.05).
CONCLUSIONS


Compared with routine health care and instruction, for patients after surgery, the education/information intervention using the mHealth app significantly reduced their nursing care needs, improved their quality of life, and increased their acceptance of using an mHealth app on a mobile device. These findings can provide a theoretical basis for future health care app design and improvement. This study suggests that an mHealth app should be incorporated into the routine care of oral cancer patients to provide medical information quickly and improve their self-management abilities, thereby reducing the patients' need for physiological care and improving their quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04049968; https://www.clinicaltrials.gov/ct2/show/NCT04049968.",2020,The overall improvement in quality of life was higher in the experimental group than in the control group (-7.24 vs -4.36).,"['After surgery, oral cancer patients', 'patients with oral cancer after receiving the intervention of a newly developed mHealth app', 'patients taking oral anticancer medications', 'oral cancer patients']","['Mobile Health App', 'mHealth app intervention and a control group (n=50) who received routine health care and instruction']","['quality of life', 'acceptability scores of the mHealth app', ""patients' quality of life, nursing care needs, and acceptance of the mHealth app"", 'psychological needs, communication needs, and care support needs', 'quality of life of oral cancer patients', 'Patient Care Needs and Improving Quality of Life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0657756,The overall improvement in quality of life was higher in the experimental group than in the control group (-7.24 vs -4.36).,"[{'ForeName': 'Tze-Fang', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Rou-Chen', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Su-Chen', 'Initials': 'SC', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Chyuan', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': 'Excellent Dental Center, Taipei City, Taiwan.'}, {'ForeName': 'Lee-Chen', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}]",JMIR mHealth and uHealth,['10.2196/18132']
2853,32712103,Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice.,"BACKGROUND & AIMS


Nonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth.
METHODS


We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13 ± 3 years; age range, 8-17 years) who received placebo and standard of care lifestyle advice in 2 double-blind, randomized clinical trials within the nonalcoholic steatohepatitis (NASH) clinical research network from 2005 through 2015. We analyzed histologic changes with respect to baseline and longitudinal change in clinical variables using regression analysis.
RESULTS


At enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH. Over a mean period of 1.6 ± 0.4 years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH. Fibrosis improved in 34% of the children but worsened in 23%. Any progression to definite NASH and/or in fibrosis was associated with adolescent age, and higher waist circumference, levels of alanine or aspartate aminotransferase, total and low-density lipoprotein cholesterol at baseline (<0.05), and over follow-up time, with increasing level of alanine aminotransferase, hemoglobin A1C (P<.05), gamma-glutamyl transferase and development of type 2 diabetes (P<.01). Increasing level of gamma-glutamyl transferase was also associated with reduced odds of any improvement (P = .003).
CONCLUSIONS


One-third of children with NAFLD enrolled in placebo groups of clinical trials had histologic features of progression within 2 years, in association with increasing obesity and serum levels of aminotransferases and loss of glucose homeostasis.",2020,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
","['We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13±3 years; age range, 8-17 years) who received', 'Children Receiving Standard of Care Lifestyle Advice']","['placebo and standard of care lifestyle advice', 'placebo', 'NASH']","['Increasing level of gamma-glutamyl transferase', 'Fibrosis', 'borderline or definite NASH', 'level of gamma-glutamyl transferase and development of type 2 diabetes', 'obesity and serum levels of aminotransferases and loss of glucose homeostasis', 'NASH or fibrosis', 'waist circumference, levels of alanine or aspartate aminotransferase, total and low density lipoprotein cholesterol at baseline, increasing level of alanine aminotransferase, hemoglobin A1C (P<.05']","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",139.0,0.180644,"Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P=.003).
","[{'ForeName': 'Stavra A', 'Initials': 'SA', 'LastName': 'Xanthakos', 'Affiliation': ""Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Lavine', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Columbia Vagelos College of Physicians and Surgeons, New York, New York. Electronic address: jl3553@columbia.edu.'}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Yates', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Schwimmer', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Molleston', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Indiana University School of Medicine/Riley Hospital for Children, Indianapolis, Indiana.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Rosenthal', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, Benioff Children's Hospital, San Francisco, California.""}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Murray', 'Affiliation': ""Pediatrics Institute, Cleveland Clinic Children's, Cleveland, Ohio.""}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': ""Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Jain', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, St. Louis University, St. Louis, Missouri.'}, {'ForeName': 'Ann O', 'Initials': 'AO', 'LastName': 'Scheimann', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tamir', 'Initials': 'T', 'LastName': 'Miloh', 'Affiliation': 'Miami Transplant Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fishbein', 'Affiliation': 'Department of Pediatrics, Feinberg Medical School of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Behling', 'Affiliation': 'Department of Pathology, Sharp Memorial Hospital; Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Diego, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Brunt', 'Affiliation': 'Department of Pathology and Immunology, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, Virginia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.034']
2854,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
2855,32717045,Association of Low-Dose Triple Combination Therapy With Therapeutic Inertia and Prescribing Patterns in Patients With Hypertension: A Secondary Analysis of the TRIUMPH Trial.,"Importance


Fixed-dose combination (FDC) therapies are being increasingly recommended for initial or early management of patients with hypertension, as they reduce treatment complexity and potentially reduce therapeutic inertia.
Objective


To investigate the association of antihypertensive triple drug FDC therapy with therapeutic inertia and prescribing patterns compared with usual care.
Design, Setting, and Participants


A post hoc analysis of the Triple Pill vs Usual Care Management for Patients With Mild-to-Moderate Hypertension (TRIUMPH) study, a randomized clinical trial of 700 patients with hypertension, was conducted. Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017. Data were analyzed from September to November 2019.
Interventions


Once-daily FDC antihypertensive pill (telmisartan, 20 mg; amlodipine, 2.5 mg; and chlorthalidone, 12.5 mg) or usual care.
Main Outcomes and Measures


Therapeutic inertia, defined as not intensifying therapy in those with blood pressure (BP) above target, was assessed at baseline and during follow-up visits. Prescribing patterns were characterized by BP-lowering drug class and treatment regimen potency. Predictors of therapeutic inertia were assessed with binomial logistic regression.
Results


Of the 700 included patients, 403 (57.6%) were female, and the mean (SD) age was 56 (11) years. Among patients who did not reach the BP target, therapeutic inertia was more common in the triple pill group compared with the usual care group at the week 6 visit (92 of 106 [86.8%] vs 124 of 194 [63.9%]; P < .001) and week 12 visit (81 of 90 [90%] vs 116 of 179 [64.8%]; P < .001). At the end of the study, 221 of 318 patients in the triple pill group (69.5%) and 182 of 329 patients in the usual care group (55.3%) reached BP targets. Among those who received treatment intensification, the increase in estimated regimen potency was greater in the triple pill group compared with the usual care group at baseline (predicted mean [SD] increase in regimen potency: triple pill, 15 [6] mm Hg; usual care, 10 [5] mm Hg; P < .001), whereas there were no significant differences at the week 6 or at week 12 visit. Clinic systolic BP level was the only consistent predictor of treatment intensification during follow-up. During follow-up, there were 23 vs 54 unique treatment regimens per 100 treated patients in the triple pill vs usual care groups, respectively (P < .001).
Conclusions and Relevance


Triple pill FDC therapy was associated with greater rates of therapeutic inertia compared with usual care. Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care. Further improvements in hypertension control could be achieved by addressing therapeutic inertia among the minority of patients who do not achieve BP control after initial FDC therapy.
Trial Registration


ANZCTR Identifier: ACTRN12612001120864.",2020,"Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care.","['700 patients with hypertension', '700 included patients, 403 (57.6%) were female, and the mean (SD) age was 56 (11) years', '318 patients in the triple pill group (69.5%) and 182 of 329 patients in the usual care group (55.3%) reached BP targets', 'Patients With Hypertension', 'patients with hypertension', 'Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017', 'Patients With Mild-to-Moderate Hypertension (TRIUMPH']","['Low-Dose Triple Combination Therapy', 'Triple Pill vs Usual Care Management', 'antihypertensive triple drug FDC therapy', 'FDC antihypertensive pill (telmisartan, 20 mg; amlodipine, 2.5 mg; and chlorthalidone, 12.5 mg) or usual care', 'Importance\n\n\nFixed-dose combination (FDC) therapies']","['6-month BP control rates', 'rates of therapeutic inertia', 'estimated regimen potency', 'blood pressure (BP', 'Clinic systolic BP level', 'BP target, therapeutic inertia']","[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3643615', 'cui_str': 'Triumph'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",700.0,0.0588462,"Despite this, triple pill FDC therapy substantially simplified prescribing patterns and improved 6-month BP control rates compared with usual care.","[{'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Asita', 'Initials': 'A', 'LastName': 'de Silva', 'Affiliation': 'Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Guggilla', 'Affiliation': 'Division of Dentistry, Division of Medical Education in English, Department of Population Medicine and Civilization Diseases Prevention, Faculty of Medicine, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Stepien', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Mysore', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'Nitish', 'Initials': 'N', 'LastName': 'Naik', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Selak', 'Affiliation': 'Department of Epidemiology and Biostatistics, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thom', 'Affiliation': 'Department of Epidemiology and Biostatistics, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control and Public Health Foundation, New Delhi, India.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.2739']
2856,32717123,Improvement in histological endpoints of MAFLD following a 12-week aerobic exercise intervention.,"BACKGROUND


Lifestyle interventions are the primary treatment for metabolic (dysfunction) associated fatty liver disease (MAFLD). However, the histological and cardiometabolic effects of aerobic exercise in MAFLD remain unclear.
AIMS


To assess the effects of a 12-week aerobic exercise intervention on histological and cardiometabolic endpoints in MAFLD.
METHODS


Patients with biopsy-confirmed MAFLD participated in a 12-week aerobic exercise intervention. Liver histology, cardiorespiratory fitness (estimated V̇O 2max  ), physical activity, anthropometry and biochemical markers were assessed at baseline, intervention completion, and 12 and 52 weeks after intervention completion.
RESULTS


Twenty-four patients completed the exercise intervention (exercise group n = 16, control group n = 8). In the exercise group, 12 weeks of aerobic exercise reduced fibrosis and hepatocyte ballooning by one stage in 58% (P = 0.034) and 67% (P = 0.020) of patients, with no changes in steatosis (P = 1.000), lobular inflammation (P = 0.739) or NAFLD activity score (P = 0.172). Estimated V̇O 2max  increased by 17% compared to the control group (P = 0.027) but this level of improvement was not maintained at 12 or 52 weeks after the intervention. Patients with fibrosis and ballooning improvement increased estimated V̇O 2max  by 25% (P = 0.020) and 26% (P = 0.010), respectively. Anthropometric reductions including body mass (P = 0.038), waist circumference (P = 0.015) and fat mass (P = 0.007) were also observed, but no patient achieved 7%-10% weight loss.
CONCLUSION


This study highlights the potential benefits of a 12-week aerobic exercise intervention in improving histological endpoints of MAFLD. The development of strategies to ensure continued engagement in aerobic exercise in MAFLD are needed.",2020,"Patients with fibrosis and ballooning improvement increased estimated V̇O 2max  by 25% (P = 0.020) and 26% (P = 0.010), respectively.",['Patients with biopsy-confirmed MAFLD participated in a 12-week'],"['aerobic exercise intervention', 'exercise intervention (exercise', 'aerobic exercise']","['waist circumference', 'steatosis', 'fibrosis and hepatocyte ballooning', 'Liver histology, cardiorespiratory fitness (estimated V̇O 2max  ), physical activity, anthropometry and biochemical markers', 'Anthropometric reductions including body mass', 'fat mass', 'Estimated V̇O 2max', 'lobular inflammation', 'NAFLD activity score', 'estimated V̇O 2max']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0227525', 'cui_str': 'Hepatic parenchymal cell'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205417', 'cui_str': 'Lobular'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0431615,"Patients with fibrosis and ballooning improvement increased estimated V̇O 2max  by 25% (P = 0.020) and 26% (P = 0.010), respectively.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': ""O'Gorman"", 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Naimimohasses', 'Affiliation': ""Department of Hepatology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Monaghan', 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Ashanty M', 'Initials': 'AM', 'LastName': 'Melo', 'Affiliation': 'Department of Immunology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Ní Fhloinn', 'Affiliation': ""Department of Hepatology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Doherty', 'Affiliation': 'Department of Immunology, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beddy', 'Affiliation': ""Department of Radiology, St James's Hospital, Dublin, Ireland.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Finn', 'Affiliation': ""Department of Histopathology, St James's Hospital and Trinity College Dublin, Dublin, Ireland.""}, {'ForeName': 'J Bernadette', 'Initials': 'JB', 'LastName': 'Moore', 'Affiliation': 'School of Food Science and Nutrition, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gormley', 'Affiliation': 'Discipline of Physiotherapy, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Department of Hepatology, St James's Hospital, Dublin, Ireland.""}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15989']
2857,32725791,"Supplemental CO 2  improves oxygen saturation, oxygen tension ,  and cerebral oxygenation in acutely hypoxic healthy subjects.","Oxygen is viewed in medicine as the sole determinant of tissue oxygenation, though carbon dioxide homeostasis is equally important and clinically often ignored. The aims of this study were as follows: (a) to examine the effects of different acute hypoxic conditions on partial pressure of arterial oxygen (  Pa   O   2      ), arterial oxygen saturation of hemoglobin (  Sa   O   2      ), and regional cerebral saturation of hemoglobin (rSO 2  ); and (b) to evaluate supplemental CO 2  as a tool to improve oxygenation in acutely hypoxic individuals. We hypothesized that exposure to gas mixtures with added CO 2  would improve oxygenation in hypoxic human subjects. Twenty healthy subjects were exposed to 5-min intervals of two gas mixtures: hypoxic gas mixture containing 8% oxygen, and a CO 2  -enriched mixture containing 8% oxygen plus either 3% or 5% CO 2  . Ten subjects received the 3% CO 2  -enriched mixture, and the remaining 10 subjects received the 5% CO 2  -enriched mixture. The order of exposure was randomized. Blood gases, pulse oximetry, end-tidal CO 2  , and cerebral oximetry were measured. Compared to the purely hypoxic gas group,  Pa   O   2      was increased in the 3% and 5% CO 2  -enriched groups by 14.9 and 9.5 mmHg, respectively. Compared to pure hypoxia,  Sa   O   2      was increased in the 3% and 5% CO 2  -enriched groups by 16.8% and 12.9%, respectively. Both CO 2  -enriched gas groups had significantly higher end-exposure rSO 2  and recovered to baseline rSO 2  within 1 min, compared to the pure hypoxic gas group, which returned to baseline in 5 min. These results suggest that in acutely hypoxic subjects, CO 2  supplementation improves blood oxygen saturation and oxygen tension as well as cerebral oxygenation measures.",2020,"Both CO 2  -enriched gas groups had significantly higher end-exposure rSO 2  and recovered to baseline rSO 2  within 1 min, compared to the pure hypoxic gas group, which returned to baseline in 5 min.","['acutely hypoxic individuals', 'hypoxic human subjects', 'Twenty healthy subjects', 'acutely hypoxic healthy subjects']","['pure hypoxia,  Sa', 'hypoxic gas mixture containing 8% oxygen, and a CO 2  -enriched mixture containing 8% oxygen plus either 3% or 5% CO 2  ']","['Blood gases, pulse oximetry, end-tidal CO 2  , and cerebral oximetry', 'partial pressure of arterial oxygen (  Pa   O   2      ), arterial oxygen saturation of hemoglobin (  Sa   O   2      ), and regional cerebral saturation of hemoglobin (rSO 2  ', 'Pa   O   2', 'blood oxygen saturation and oxygen tension', 'oxygen saturation, oxygen tension ,  and cerebral oxygenation', 'cerebral oxygenation measures']","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0068879', 'cui_str': 'nitrox'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.0431829,"Both CO 2  -enriched gas groups had significantly higher end-exposure rSO 2  and recovered to baseline rSO 2  within 1 min, compared to the pure hypoxic gas group, which returned to baseline in 5 min.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stepanek', 'Affiliation': 'Mayo Clinic, Aerospace Medicine and Vestibular Research Laboratory (AMVRL), Scottsdale, AZ, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Dunn', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Scottsdale, AZ, USA.'}, {'ForeName': 'Gaurav N', 'Initials': 'GN', 'LastName': 'Pradhan', 'Affiliation': 'Mayo Clinic, Aerospace Medicine and Vestibular Research Laboratory (AMVRL), Scottsdale, AZ, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cevette', 'Affiliation': 'Mayo Clinic, Aerospace Medicine and Vestibular Research Laboratory (AMVRL), Scottsdale, AZ, USA.'}]",Physiological reports,['10.14814/phy2.14513']
2858,31821466,Efficacy of Adjunctive Zinc in Improving the Treatment Outcomes in Hospitalized Children with Pneumonia: A Randomized Controlled Trial.,"BACKGROUND


The mortality rate of pneumonia is high, placing a huge burden on developing countries. Healthcare professionals use zinc as an adjunctive treatment for children with pneumonia; however, this contradicts with some published reports. Thus, this study aimed to assess the efficacy of zinc supplementation on the treatment outcomes of pneumonia.
METHODS


A randomized, double-blind, placebo-controlled trial was conducted on hospitalized children with pneumonia. The children randomly received either zinc bis-glycinate (15 mg elemental zinc) or placebo, twice per day. The primary outcome was the resolution time of pneumonia, and the secondary outcomes were the duration of hospitalization and the recovery times of each clinical symptom.
RESULTS


Out of the 91 children, 65 (71.4%) were males. The resolution period of clinical pneumonia was significantly shorter in the zinc group than the placebo group (48 and 72 h, respectively; hazard ratio = 0.585, 95% confidence interval 0.377-0.908). Similarly, the hospitalization period and the resolution period of fever were shorter in the zinc group [96 and 144 h (p = 0.008), and 24 and 42 h (p = 0.002), respectively]. Children receiving zinc needed a median of 28 h to reach the normal level of oxygen saturation compared to 48 h required by children under placebo (p = 0.014).
CONCLUSION


Zinc supplementation enhanced the treatment outcomes of pneumonia, by reducing the resolution period of pneumonia and normalizing oxygen levels and body temperature. The length of hospital stay for children receiving zinc was shorter than those receiving placebo.",2020,"The resolution period of clinical pneumonia was significantly shorter in the zinc group than the placebo group (48 and 72 h, respectively; hazard ratio = 0.585, 95% confidence interval 0.377-0.908).","['children with pneumonia', 'Hospitalized Children with Pneumonia', '91 children, 65 (71.4%) were males', 'hospitalized children with pneumonia']","['Zinc supplementation', 'Adjunctive Zinc', 'zinc supplementation', 'zinc bis-glycinate (15\u2009mg elemental zinc) or placebo', 'placebo']","['resolution period of clinical pneumonia', 'hospitalization period and the resolution period of fever', 'resolution period of pneumonia and normalizing oxygen levels and body temperature', 'duration of hospitalization and the recovery times of each clinical symptom', 'length of hospital stay', 'normal level of oxygen saturation', 'resolution time of pneumonia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0078777', 'cui_str': 'Bis (dibutyldithiocarbamato) zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",91.0,0.583354,"The resolution period of clinical pneumonia was significantly shorter in the zinc group than the placebo group (48 and 72 h, respectively; hazard ratio = 0.585, 95% confidence interval 0.377-0.908).","[{'ForeName': 'Lakkana', 'Initials': 'L', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Preventive Medicine, Srinakharinwirot University, Nakorn Nayok 26120, Thailand.'}, {'ForeName': 'Sanguansak', 'Initials': 'S', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Nakorn Nayok 26120, Thailand.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz082']
2859,32720384,Applicability of the REDUCE-IT trial to the FAST-MI registry. Are the results of randomized trials relevant in routine clinical practice?,"BACKGROUND


The reduction of cardiovascular events with icosapent ethyl-intervention trial (REDUCE-IT) trial revealed robust atherosclerotic cardiovascular risk reduction with a strategy comprising high-dose omega-3 icosapent ethyl vs placebo in statin-treated patients with elevated triglycerides and controlled low-density lipoprotein cholesterol (LDL-C).
HYPOTHESIS


Are the results of the REDUCE-IT trial applicable to the French registry on acute ST-elevation and non-ST-elevation myocardial infarction (FAST-MI) population?
METHODS


Data were extracted from the FAST-MI 2010 and 2015 registries. We applied the REDUCE-IT enrolment criteria (triglycerides 150-500 mg/dL and LDL-C 40-100 mg/dL on statins) to the FAST-MI population in patients aged ≥45 years who had detailed lipid values postacute hospitalization, focusing on their clinical profile and cardiovascular prognosis.
RESULTS


Of the 3789 FAST-MI patients with a full lipid profile (median 11.1 [IQR 7.6-17.4] months after hospitalization for myocardial infarction), 472 (12.5%; 95% CI 11.4-13.5) met the eligibility criteria for REDUCE-IT (REDUCE-IT-like group). The cardiovascular event rate (all-cause death, nonfatal myocardial infarction, nonfatal stroke) was 36.7 (95% CI 27.8-48.6) per 1000 person-years for the REDUCE-IT-like group, which compares with the 36.9 (95% CI 26.1-51.5) per 1000 person-years (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) reported in the REDUCE-IT trial. The residual cardiovascular risk related to elevated triglycerides in the REDUCE-IT-like group was similar to the risk in the REDUCE-IT trial.
CONCLUSIONS


If the results of REDUCE-IT are applied to patients hospitalized for a myocardial infarction in France, 12.5% of these patients could benefit from a strategy of high-dose omega-3 icosapent ethyl on top of contemporary therapy including statins to improve their clinical outcomes.",2020,"The cardiovascular event rate (all-cause death, nonfatal myocardial infarction, nonfatal stroke) was 36.7 (95% CI 27.8-48.6) per 1000 person-years for the REDUCE-IT-like group, which compares with the 36.9 (95% CI 26.1-51.5) per 1000 person-years (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) reported in the REDUCE-IT trial.","['patients aged ≥45\u2009years who had detailed lipid values postacute hospitalization, focusing on their clinical profile and cardiovascular prognosis', 'Of the 3789 FAST-MI patients with a', 'statin-treated patients with elevated triglycerides and controlled low-density lipoprotein cholesterol (LDL-C', 'Data were extracted from the FAST-MI 2010 and 2015 registries']","['LDL-C 40-100\u2009mg/dL on statins', 'omega-3 icosapent ethyl vs placebo']","['full lipid profile', 'cardiovascular event rate (all-cause death, nonfatal myocardial infarction, nonfatal stroke', '1000 person-years (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C1276061', 'cui_str': 'Acute non-ST segment elevation myocardial infarction'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",3789.0,0.0901599,"The cardiovascular event rate (all-cause death, nonfatal myocardial infarction, nonfatal stroke) was 36.7 (95% CI 27.8-48.6) per 1000 person-years for the REDUCE-IT-like group, which compares with the 36.9 (95% CI 26.1-51.5) per 1000 person-years (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) reported in the REDUCE-IT trial.","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Ferrières', 'Affiliation': 'Department of Cardiology, Toulouse Rangueil University Hospital, Toulouse University School of Medicine, Toulouse, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Bataille', 'Affiliation': 'Department of Cardiology, Toulouse Rangueil University Hospital, Toulouse University School of Medicine, Toulouse, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Puymirat', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Schiele', 'Affiliation': 'Department of Cardiology, Regional University Hospital Jean Minjoz, Besançon, France.'}, {'ForeName': 'Tabassome', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), AP-HP, Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Danchin', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cardiology,['10.1002/clc.23437']
2860,32725584,"Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder-Wet.","BACKGROUND


In older patients with overactive bladder (OAB), mirabegron, a β 3 -adrenoreceptor agonist, represents an alternative treatment that may have a favorable risk-benefit profile.
OBJECTIVES


Our objective was to further examine the safety and tolerability of mirabegron versus placebo treatment in patients aged ≥ 65 years with OAB-wet.
METHODS


We conducted a 12-week, double-blind, randomized, placebo-controlled phase IV study to compare mirabegron with placebo. Community-dwelling patients aged ≥ 65 years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24 h over a 3-day diary) were randomized to receive placebo or mirabegron 25 mg/day (optional dose escalation to 50 mg/day at week 4 or 8). Safety analyses were performed for adverse events (AEs) and vital signs on all randomized patients who received one or more dose of study drug.
RESULTS


Treatment-emergent AEs (TEAEs), the majority mild or moderate in severity, were reported in 39.4% of placebo patients and 44.2 and 49.8% of those who received mirabegron 25 mg or 50 mg, respectively. The most common TEAEs in mirabegron-treated patients were urinary tract infection, headache, and diarrhea. The incidence of TEAEs was slightly higher in mirabegron patients aged ≥ 75 years than in those aged < 75 years. There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups. TEAEs tended to occur early post exposure and were not dose related.
CONCLUSIONS


Mirabegron treatment was well-tolerated in older adults with OAB-wet. Safety and tolerability were consistent with the known mirabegron safety profile.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov: NCT02216214.",2020,"There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups.","['patients aged\u2009≥', '65\xa0years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24\xa0h over a 3-day diary', 'older adults with OAB-wet', '65\xa0years with OAB-wet', 'Patients\u2009≥', '65\xa0years with Overactive Bladder-Wet', 'Community-dwelling patients aged\u2009≥', 'older patients with overactive bladder (OAB']","['Placebo', 'placebo']","['vital signs', 'Safety and tolerability', 'safety and tolerability', 'incidence of TEAEs', 'Safety and Tolerability', 'urinary tract infection, headache, and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.543871,"There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups.","[{'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, MG408, Toronto, Ontario, M4N 3M5, Canada. s.herschorn@utoronto.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St Elizabeth's Medical Center, 736 Cambridge Street, Brighton, MA, USA.""}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Medicine, University of Alberta, 1-198 Clinical Sciences Building, 11350 83 Avenue, Edmonton, AB, Canada.'}]",Drugs & aging,['10.1007/s40266-020-00783-w']
2861,32719487,Assessment of cognitive and neural recovery in survivors of pediatric brain tumors in a pilot clinical trial using metformin.,"We asked whether pharmacological stimulation of endogenous neural precursor cells (NPCs) may promote cognitive recovery and brain repair, focusing on the drug metformin, in parallel rodent and human studies of radiation injury. In the rodent cranial radiation model, we found that metformin enhanced the recovery of NPCs in the dentate gyrus, with sex-dependent effects on neurogenesis and cognition. A pilot double-blind, placebo-controlled crossover trial was conducted (ClinicalTrials.gov, NCT02040376) in survivors of pediatric brain tumors who had been treated with cranial radiation. Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus were evaluated as endpoints. Twenty-four participants consented and were randomly assigned to complete 12-week cycles of metformin (A) and placebo (B) in either an AB or BA sequence with a 10-week washout period at crossover. Blood draws were conducted to monitor safety. Feasibility was assessed as recruitment rate, medication adherence and procedural adherence. Linear mixed modeling was used to examine cognitive and MRI outcomes as a function of cycle, sequence and treatment. We found no clinically relevant safety concerns and no serious adverse events associated with metformin. Sequence effects were observed for all cognitive outcomes in our linear mixed models. For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory. We present evidence that a clinical trial examining the effects of metformin on cognition and brain structure is feasible in long-term survivors of pediatric brain tumors and that metformin is safe to use and tolerable in this population. This pilot trial was not intended to test the efficacy of metformin for cognitive recovery and brain growth, but the preliminary results are encouraging and warrant further investigation in a large multicenter phase 3 trial.",2020,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","['Twenty-four participants consented', 'survivors of pediatric brain tumors', 'survivors of pediatric brain tumors who had been treated with cranial radiation']","['metformin (A) and placebo (B', 'pharmacological stimulation of endogenous neural precursor cells (NPCs', 'metformin', 'placebo']","['Safety, feasibility, cognitive tests and MRI measures of white matter and the hippocampus', 'declarative and working memory', 'recruitment rate, medication adherence and procedural adherence', 'recovery of NPCs']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0441694', 'cui_str': 'Pharmacological stimulation'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}]",24.0,0.0743775,"For the subset of participants with complete data in cycle 1, metformin was associated with better performance than placebo on tests of declarative and working memory.","[{'ForeName': 'Ramy', 'Initials': 'R', 'LastName': 'Ayoub', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Ruddy', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Adeoye', 'Initials': 'A', 'LastName': 'Oyefiade', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Derkach', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ades-Aron', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Shirzadi', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Fieremans', 'Affiliation': 'Center for Biomedical Imaging, Department of Radiology, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'MacIntosh', 'Affiliation': 'Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jovanka', 'Initials': 'J', 'LastName': 'Skocic', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Division of Haematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Freda D', 'Initials': 'FD', 'LastName': 'Miller', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Cindi M', 'Initials': 'CM', 'LastName': 'Morshead', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada. cindi.morshead@utoronto.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences and Mental Health Program, Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada. donald.mabbott@sickkids.ca.'}]",Nature medicine,['10.1038/s41591-020-0985-2']
2862,32720906,"Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil: Randomized Controlled Trial.","BACKGROUND


Pregnancy during adolescence is prevalent in low- and middle-income countries (LMICs), which is associated with various adverse outcomes that can be prevented with home visiting programs. However, testing these interventions in LMICs can be challenging due to limited resources. The use of electronic data collection via smartphones can be an alternative and ideal low-cost method to measure outcomes in an environment with adverse conditions.
OBJECTIVE


Our study had two objectives: to test the efficacy of a nurse home visiting intervention on maternal parenting and well-being measured by an electronic daily diary (eDiary), and to investigate the compliance rate of the eDiary measurement method.
METHODS


We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse home visiting program, for adolescent mothers living in an urban deprived area of São Paulo, Brazil. A total of 169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40). Primeiros Laços is a home visiting intervention delivered by trained nurses tailored to first-time pregnant adolescents and their children, starting during the first 16 weeks of pregnancy until the child reaches 24 months of age. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and when the child was 3, 6, and 12 months of age. At 18 months, participants were assessed regarding maternal parenting and parental well-being using a 7-consecutive-day eDiary. The smartphone app was programmed to notify participants every day at 9:00 PM over a period of seven days.
RESULTS


We were able to contact 57/80 (71%) participants (29 from the intervention group and 28 from the control group) when the child was 18 months of age. Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol. The daily compliance rate ranged from 49% to 70%. Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, P=.01).
CONCLUSIONS


The Primeiros Laços intervention improved maternal parenting and parental well-being, demonstrating its promise for low-income adolescent mothers. The compliance rate of the eDiary assessment showed that it was generally accepted by adolescent mothers with limited resources. Future studies can implement ambulatory assessment in LMICs via smartphones to measure mother and child behaviors.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02807818; https://clinicaltrials.gov/ct2/show/NCT02807818.",2020,"Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds","['adolescent mothers living in an urban deprived area of São Paulo, Brazil', '169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40', 'Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol', 'adolescent mothers with limited resources', 'Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil']","['Primeiros Laços, a nurse home visiting program', 'nurse home visiting intervention']","['compliance rate of the eDiary assessment', 'maternal parenting behavior of the mother telling a story or singing to the child (odds', 'maternal parenting behavior of the mother telling a story or singing to the child', 'Maternal Parenting Electronic Diary', 'maternal parenting and parental well-being', 'daily compliance rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",169.0,0.0833277,"Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Argeu', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chiesa', 'Affiliation': 'Collective Health Nursing Department, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lislaine', 'Initials': 'L', 'LastName': 'Fracolli', 'Affiliation': 'Collective Health Nursing Department, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Department of Preventive Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Euripedes C', 'Initials': 'EC', 'LastName': 'Miguel', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",JMIR mHealth and uHealth,['10.2196/13686']
2863,32725695,Effects of blood flow restriction on muscle size and gene expression in muscle during immobilization: A pilot study.,"PURPOSE


Muscle mass is known to rapidly decrease with muscle disuse. Previous reports suggest that repetitive blood flow restriction (BFR) mitigates the reduction of muscle mass with disuse. However, the effects of BFR on muscle atrophy and gene expression levels in muscle during cast immobilization have not been clarified.
METHODS


To investigate the effect of BFR on muscle atrophy and gene expression levels during cast immobilization in humans, we recruited 10 healthy males who were randomly divided into the control and BFR treatment groups. All subjects were immobilized with a cast for 14 days. BFR treatment was conducted only in the BFR group. We evaluated cross sectional area (CSA) of thigh muscles by magnetic resonance imaging before and 14 days after cast immobilization. A percutaneous biopsy of the vastus lateralis muscle (VL) was performed before and 1, 7, and 14 days after cast immobilization. Expression of genes related to muscle atrophy and synthesis were evaluated using real-time PCR.
RESULTS


The CSA of the VL and the thigh flexor muscles were significantly decreased in both groups; however, percent decrease in CSA was significantly smaller in the BFR group compared with the control group. In two-way repeated ANOVA analysis, the time × treatment interaction in gene expression of the muscle-specific ubiquitin ligases muscle ring finger 1 (MuRF1) was significant, and elevated MURF1 expression level by cast immobilization was seemed to be suppressed by the BFR treatment.
CONCLUSION


BFR treatment may prevent reduced VL and thigh flexor muscles and increased MuRF1 expression level during cast immobilization. Further study is required to confirm these results.",2020,"The CSA of the VL and the thigh flexor muscles were significantly decreased in both groups; however, percent decrease in CSA was significantly smaller in the BFR group compared with the control group.","['humans, we recruited 10 healthy males who were randomly divided into the control and BFR treatment groups', 'muscle during immobilization']","['blood flow restriction', 'BFR', 'repetitive blood flow restriction (BFR']","['reduced VL and thigh flexor muscles and increased MuRF1 expression level', 'muscle size and gene expression', 'CSA of the VL and the thigh flexor muscles', 'elevated MURF1 expression level', 'CSA', 'muscle atrophy and gene expression levels']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}]",10.0,0.0159256,"The CSA of the VL and the thigh flexor muscles were significantly decreased in both groups; however, percent decrease in CSA was significantly smaller in the BFR group compared with the control group.","[{'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Kakehi', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Tamura', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kubota', 'Affiliation': 'Department of Sports Medicine, Juntendo University Graduate School of Health and Sports Science, Chiba, Japan.'}, {'ForeName': 'Kageumi', 'Initials': 'K', 'LastName': 'Takeno', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Minako', 'Initials': 'M', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Keishoku', 'Initials': 'K', 'LastName': 'Sakuraba', 'Affiliation': 'Department of Sports Medicine, Juntendo University Graduate School of Health and Sports Science, Chiba, Japan.'}, {'ForeName': 'Ryuzo', 'Initials': 'R', 'LastName': 'Kawamori', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}]",Physiological reports,['10.14814/phy2.14516']
2864,32721437,"Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis.","BACKGROUND & AIMS


Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission.
METHODS


We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks.
RESULTS


At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
CONCLUSIONS


In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.",2020,"Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
","['Patients With Eosinophilic Esophagitis', 'Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites']","['budesonide orodispersible tablet (BOT) vs placebo', 'Placebo', 'Budesonide Orodispersible Tablets', 'Swallowed topical-acting corticosteroids', 'BOT 0.5 mg twice daily (n=68), BOT 1.0 mg twice daily (n=68), or placebo', 'BOT', 'placebo']","['Median time to relapse', 'Morning serum levels of cortisol', 'asymptomatic, low serum levels of cortisol', 'frequency of adverse events', 'efficacy and safety', 'effective and well tolerated', 'Clinically manifested candidiasis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}]",204.0,0.627341,"Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Straumann', 'Affiliation': 'Swiss Eosinophilic Esophagitis Research Group, Olten, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland. Electronic address: alex.straumann@hin.ch.'}, {'ForeName': 'Alfredo J', 'Initials': 'AJ', 'LastName': 'Lucendo', 'Affiliation': 'Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Miehlke', 'Affiliation': 'Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Center for Esophageal Disorders, University Hospital Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vieth', 'Affiliation': 'Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schlag', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Biedermann', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cecilio Santander', 'Initials': 'CS', 'LastName': 'Vaquero', 'Affiliation': 'Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain; Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Ciriza de Los Rios', 'Affiliation': 'Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmoecker', 'Affiliation': 'Department of Gastroenterology, Sana Klinikum Lichtenberg, Berlin, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Madisch', 'Affiliation': 'Department of Gastroenterology, Clinical-Center Region Hannover Clinic Siloah, Hannover, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Hruz', 'Affiliation': 'Department of Gastroenterology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hayat', 'Affiliation': ""Department of Gastroenterology, Saint George's University Hospitals National Health Service Trust, London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'von Arnim', 'Affiliation': 'Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Albert Jan', 'Initials': 'AJ', 'LastName': 'Bredenoord', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schubert', 'Affiliation': 'Private Practice, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Attwood', 'Affiliation': 'Department of Health Services Research, Durham University, Durham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2020.07.039']
2865,32728820,Exercise training improves vascular function in patients with Alzheimer's disease.,"PURPOSE


Vascular dysfunction has been demonstrated in patients with Alzheimer's disease (AD). Exercise is known to positively affect vascular function. Thus, the aim of our study was to investigate exercise-induced effects on vascular function in AD.
METHODS


Thirty-nine patients with AD (79 ± 8 years) were recruited and randomly assigned to exercise training (EX, n = 20) or control group (CTRL, n = 19). All subjects performed 72 treatment sessions (90 min, 3 t/w). EX included moderate-high-intensity aerobic and strength training. CTRL included cognitive stimuli (visual, verbal, auditive). Before and after the 6-month treatment, the vascular function was measured by passive-leg movement test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, %). A blood sample was analyzed for vascular endothelial growth factor (VEGF). Arterial blood flow (BF) and shear rate (SR) were measured during EX and CTRL during a typical treatment session.
RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ 99.056 ml/min, p = 0.004), AUC (+ 37.359AU, p = 0.037) and VEGF (+ 8.825 pg/ml, p = 0.004). In the CTRL group, no difference between pre- and post-treatment was found for any variable. Increase in BF and SR was demonstrated during EX (BF + 123%, p < 0.05; SR + 134%, p < 0.05), but not during CTRL treatment.
CONCLUSION


Exercise training improves peripheral vascular function in AD. These ameliorations may be due to the repetitive increase in SR during exercise which triggers NO and VEGF upregulation. This approach might be included in standard AD clinical practice as an effective strategy to treat vascular dysfunction in this population.",2020,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[""patients with Alzheimer's disease"", ""patients with Alzheimer's disease (AD"", 'Thirty-nine patients with AD (79\u2009±\u20098\xa0years']","['exercise training (EX, n\u2009=\u200920) or control group (CTRL', 'Exercise training']","['Arterial blood flow (BF) and shear rate (SR', 'CTRL included cognitive stimuli (visual, verbal, auditive', 'vascular endothelial growth factor (VEGF', 'passive-leg movement\xa0test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, ', 'FMD', 'PLM ∆peak ', 'moderate-high-intensity aerobic and strength training', 'peripheral vascular function', 'vascular function', 'BF and SR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",39.0,0.064598,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy. massimo.venturelli@univr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Di Baldassarre', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic Medicine and Orthopedic Science, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Giuriato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ghinassi', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. A. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04447-w']
2866,32723718,Haptic Nudges Increase Affected Upper Limb Movement During Inpatient Stroke Rehabilitation: Multiple-Period Randomized Crossover Study.,"BACKGROUND


As many as 80% of stroke survivors experience upper limb (UL) disability. The strong relationships between disability, lost productivity, and ongoing health care costs mean reducing disability after stroke is critical at both individual and society levels. Unfortunately, the amount of UL-focused rehabilitation received by people with stroke is extremely low. Activity monitoring and promotion using wearable devices offer a potential technology-based solution to address this gap. Commonly, wearable devices are used to deliver a haptic nudge to the wearer with the aim of promoting a particular behavior. However, little is known about the effectiveness of haptic nudging in promoting behaviors in patient populations.
OBJECTIVE


This study aimed to estimate the effect of haptic nudging delivered via a wrist-worn wearable device on UL movement in people with UL disability following stroke undertaking inpatient rehabilitation.
METHODS


A multiple-period randomized crossover design was used to measure the association of UL movement with the occurrence of haptic nudge reminders to move the affected UL in 20 people with stroke undertaking inpatient rehabilitation. UL movement was observed and classified using movement taxonomy across 72 one-minute observation periods from 7:00 AM to 7:00 PM on a single weekday. On 36 occasions, a haptic nudge to move the affected UL was provided just before the observation period. On the other 36 occasions, no haptic nudge was given. The timing of the haptic nudge was randomized across the observation period for each participant. Statistical analysis was performed using mixed logistic regression. The effect of a haptic nudge was evaluated from the intention-to-treat dataset as the ratio of the odds of affected UL movement during the observation period following a ""Planned Nudge"" to the odds of affected limb movement during the observation period following ""No Nudge.""
RESULTS


The primary intention-to-treat analysis showed the odds ratio (OR) of affected UL movement following a haptic nudge was 1.44 (95% CI 1.28-1.63, P<.001). The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).
CONCLUSIONS


Haptic nudging delivered via a wrist-worn wearable device increases affected UL movement in people with UL disability following stroke undertaking inpatient rehabilitation. The promoted movement appears to be specific to the instructions given.
TRIAL REGISTRATION


Australia New Zealand Clinical Trials Registry 12616000654459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370687&isReview=true.",2020,"The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).
","['20 people with stroke undertaking inpatient rehabilitation', 'people with UL disability following stroke undertaking inpatient rehabilitation']","['haptic nudging delivered via a wrist-worn wearable device', 'Haptic nudging delivered via a wrist-worn wearable device', 'haptic nudge']","['Upper Limb Movement', 'odds ratio (OR) of affected UL movement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",20.0,0.185218,"The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).
","[{'ForeName': 'Nada Elizabeth June', 'Initials': 'NEJ', 'LastName': 'Signal', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Rashid', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Callaghan Innovation, Christchurch, New Zealand.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Almesfer', 'Affiliation': 'Exsurgo Rehabilitation, Auckland, New Zealand.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Assessment, Treatment and Rehabilitation Department, Waitakere Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/17036']
2867,32723668,"Effects of Corrective Exercises on Posture, Pain, and Muscle Activation of Patients With Chronic Neck Pain Exposed to Anterior-Posterior Perturbation.","OBJECTIVES


This study aimed to evaluate the effects of corrective exercises on posture, pain, and muscle activation of patients with chronic neck pain exposed to anterior-posterior perturbation.
METHODS


A total of 32 women (37.76 ± 3.83 years) with chronic, nonspecific neck pain were randomized into corrective exercise and control groups. The experimental group underwent a corrective exercise program for 8 weeks, 30 min/d, 3 days per week. The control group received active self-exercise instructions. Neck pain, forward head and protracted shoulder posture, and timing of superficial neck muscle activation were evaluated using the visual analog scale, photogrammetry, and electromyogram, respectively, before and then 48 hours after the 8-week program for both the experimental and control groups. All measurements at pretest and posttest were taken by a blinded assessor.
RESULTS


Significant alterations were observed in cervical angle (P = .003, effect size = 0.329), shoulder angle (P = .008, effect size = 0.457), neck pain and disability (P = .009, effect size = 0.645), movement control (P = .038, effect size = 0.353), activation onset of the upper trapezius (P = .015, effect size = 0.746), the sternocleidomastoid (P = .018, effect size = 0.879) and cervical erector spinae (P = .031, effect size = 0.765), and the root mean square of the upper trapezius (P = .033, effect size = 0.742), the sternocleidomastoid (P = .041, effect size = 0.587), and the cervical erector spinae (P = .024, effect size = 0.832) in the intervention group from pre- to posttest (P < .05).
CONCLUSION


Positive and significant alterations have been observed in the forward head and protracted shoulder posture, the timing of superficial neck muscle activation, neck pain, and disability in female patients with chronic neck pain exposed to anterior-posterior perturbation after performing an 8-week corrective exercise program.",2020,"RESULTS


Significant alterations were observed in cervical angle (P = .003, effect size = 0.329), shoulder angle (P = .008, effect size = 0.457), neck pain and disability (P = .009, effect size = 0.645), movement control (P ","['patients with chronic neck pain exposed to anterior-posterior perturbation', 'Patients', 'female patients with chronic neck pain', '32 women (37.76 ± 3.83 years) with chronic, nonspecific neck pain']","['active self-exercise instructions', 'Corrective Exercises', 'corrective exercise', 'corrective exercises', 'corrective exercise program']","['activation onset of the upper trapezius', 'Posture, Pain, and Muscle Activation', 'cervical erector spinae ', 'root mean square of the upper trapezius', 'Neck pain, forward head and protracted shoulder posture, and timing of superficial neck muscle activation', 'shoulder angle', 'cervical erector spinae', 'cervical angle', 'posture, pain, and muscle activation', 'neck pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",32.0,0.0646873,"RESULTS


Significant alterations were observed in cervical angle (P = .003, effect size = 0.329), shoulder angle (P = .008, effect size = 0.457), neck pain and disability (P = .009, effect size = 0.645), movement control (P ","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Mehri', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran. Electronic address: letafatkaramir@yahoo.com.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khosrokiani', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.11.032']
2868,32728976,Effects of a 12-week home exercise therapy program on pain and neuromuscular activity in patients with patellofemoral pain syndrome.,"INTRODUCTION


The aim of this study is to evaluate the effects of a 12-week home exercise therapy program on pain, function and neuromuscular activity of the vastus medialis and vastus lateralis.
MATERIALS AND METHODS


Fifty patients with patellofemoral pain syndrome were treated with a 12-week online home exercise program. The primary outcomes of pain and function were assessed at the 12-week follow-up using the Visual Analog Scale and Kujala Score, respectively. Secondary outcomes were the muscle onset time and the ratio of vastus medialis and vastus lateralis during different daily activities.
RESULTS


After 12 weeks, patients showed significant (p < 0.05) improvements of 27 points on the Visual Analog Scale and 10 points on Kujala Score. Differences in pre-post comparison regarding both temporal and amplitude-related neurophysiological differences between the vastus medialis and lateralis were only found when the subjects were divided into groups of different electromyographic patterns. Then changes in the pre-post comparison were particularly evident in the patient group with a delayed vastus medialis onset and a lower activity of the vastus medialis compared to the VL.
CONCLUSION


Pain and function improved significantly after a home exercise therapy program in patients with patellofemoral pain syndrome. In addition, patients with a delayed onset or reduced activity of the vastus medialis compared to the vastus lateralis experienced a reduction in this imbalance.",2020,"After 12 weeks, patients showed significant (p < 0.05) improvements of 27 points on the Visual Analog Scale and 10 points on Kujala Score.","['Fifty patients with patellofemoral pain syndrome', 'patients with patellofemoral pain syndrome']","['home exercise therapy program', 'online home exercise program']","['Visual Analog Scale and Kujala Score', 'muscle onset time and the ratio of vastus medialis and vastus lateralis during different daily activities', 'pain and function', 'pain, function and neuromuscular activity', 'pain and neuromuscular activity', 'Visual Analog Scale and 10 points on Kujala Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",50.0,0.019378,"After 12 weeks, patients showed significant (p < 0.05) improvements of 27 points on the Visual Analog Scale and 10 points on Kujala Score.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Kölle', 'Affiliation': 'Institut für Rehabilitationsmedizinische Forschung, Universität Ulm, Am Kurpark 1, 88422, Bad Buchau, Germany. theresa.koelle@ifr-ulm.de.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Alt', 'Affiliation': 'Institut für Sport- Und Bewegungswissenschaft, Universität Stuttgart, Allmandring 28, 70569, Stuttgart, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wagner', 'Affiliation': 'Hessingpark Clinic, Hessingstrasse 17, 86199, Augsburg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03543-y']
2869,32722659,Cognitive and emotional empathy after stimulation of brain mineralocorticoid and NMDA receptors in patients with major depression and healthy controls.,"Mineralocorticoid receptors (MR) are predominantly expressed in the hippocampus and prefrontal cortex. Both brain areas are associated with social cognition, which includes cognitive empathy (ability to understand others' emotions) and emotional empathy (ability to empathize with another person). MR stimulation improves memory and executive functioning in patients with major depressive disorder (MDD) and healthy controls, and leads to glutamate-mediated N-methyl-D-aspartate receptor (NMDA-R) signaling. We examined whether the beneficial effects of MR stimulation can be extended to social cognition (empathy), and whether DCS would have additional beneficial effects. In this double-blind placebo-controlled single-dose study, we randomized 116 unmedicated MDD patients (mean age 34 years, 78% women) and 116 age-, sex-, and education years-matched healthy controls to four conditions: MR stimulation (fludrocortisone (0.4 mg) + placebo), NMDA-R stimulation (placebo + D-cycloserine (250 mg)), MR and NMDA-R stimulation (both drugs), or placebo. Cognitive and emotional empathy were assessed by the Multifaceted Empathy Test. The study was registered on clinicaltrials.gov (NCT03062150). MR stimulation increased cognitive empathy across groups, whereas NMDA-R stimulation decreased cognitive empathy in MDD patients only. Independent of receptor stimulation, cognitive empathy did not differ between groups. Emotional empathy was not affected by MR or NMDA-R stimulation. However, MDD patients showed decreased emotional empathy compared with controls but, according to exploratory analyses, only for positive emotions. We conclude that MR stimulation has beneficial effects on cognitive empathy in MDD patients and healthy controls, whereas NMDA-R stimulation decreased cognitive empathy in MDD patients. It appears that MR rather than NMDA-R are potential treatment targets to modulate cognitive empathy in MDD.",2020,"Independent of receptor stimulation, cognitive empathy did not differ between groups.","['patients with major depression and healthy controls', 'patients with major depressive disorder (MDD) and healthy controls', '116 unmedicated MDD patients (mean age 34 years, 78% women) and 116 age-, sex-, and education years-matched healthy controls to four conditions']","['MR stimulation', 'brain mineralocorticoid and NMDA receptors', 'MR stimulation (fludrocortisone (0.4\u2009mg)\u2009+\u2009placebo), NMDA-R stimulation (placebo\u2009+\u2009D-cycloserine (250\u2009mg)), MR and NMDA-R stimulation (both drugs), or placebo', 'NMDA-R stimulation', 'placebo']","['Cognitive and emotional empathy', 'cognitive empathy', 'emotional empathy', 'Emotional empathy', 'memory and executive functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0066563', 'cui_str': 'Mineralocorticoid Receptor'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026160', 'cui_str': 'Mineralocorticoid hormone'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0016280', 'cui_str': 'Fludrocortisone'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",116.0,0.0509834,"Independent of receptor stimulation, cognitive empathy did not differ between groups.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Nowacki', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Woo Ri', 'Initials': 'WR', 'LastName': 'Chae', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Ikram', 'Initials': 'I', 'LastName': 'Abu-Tir', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Christian Eric', 'Initials': 'CE', 'LastName': 'Deuter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Piber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Hindenburgdamm 30, 12203, Berlin, Germany. christian.otte@charite.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0777-x']
2870,32726513,Scalene and sternocleidomastoid activation during normoxic and hypoxic incremental inspiratory loading.,"The purpose of this study was to examine scalene (SA) and sternocleidomastoid (SM) activation during normoxic (norm-ITL; FIO 2   = 21%) and hypoxic (hyp-ITL; FIO 2   = 15%) incremental inspiratory threshold loading (ITL). Thirteen healthy participants (33 ± 4 years, 9 female) performed two ITL tests breathing randomly assigned gas mixtures through an inspiratory loading device where the load was increased every two minutes until task failure. SA and SM root mean square (RMS) electromyography (EMG) were calculated and expressed as a percentage of maximum (RMS %max  ) to reflect muscle activation intensity. Myoelectric manifestations of fatigue were characterized as decreased SA or SM EMG median frequency during maximum inspiratory pressure maneuvers before and after ITL. Dyspnea was recorded at baseline and task failure. Ventilatory parameters and mouth pressure (Pm) were recorded throughout the ITL. SA,RMS %max  and SM,RMS %max  increased in association with ITL load (p ≤ .01 for both). SA,RMS %max  was similar between norm-ITL and hyp-ITL (p = .17), whereas SM,RMS %max  was greater during the latter (p = .001). Neither SA nor SM had a decrease in EMG median frequency after ITL (p = .75 and 0.69 respectively). Pm increased in association with ITL load (p < .001) and tended to be higher during hyp-ITL compared to norm-ITL (p = .05). Dyspnea was similar during both conditions (p > .05). There was a trend for higher tidal volumes during hyp-ITL compared to norm-ITL (p = .10). Minute ventilation was similar between both conditions (p = .23). RMS, %max  of the SA and SM increased linearly with increasing ITL. The presence of hypoxia only increased SM activation. Neither SA nor SM presented myoelectric manifestations of fatigue during both conditions.",2020,"SA,RMS %max  and SM,RMS %max  increased in association with ITL load (p ≤ .01 for both).","['Thirteen healthy participants (33\xa0±\xa04 years, 9 female']",['ITL tests breathing randomly assigned gas mixtures through an inspiratory loading device'],"['Dyspnea', 'scalene (SA) and sternocleidomastoid (SM) activation', 'EMG median frequency', 'RMS, %max  of the SA and SM increased linearly with increasing ITL', 'SA,RMS %max', 'Ventilatory parameters and mouth pressure (Pm', 'SM activation', 'Minute ventilation', 'SA and SM root mean square (RMS) electromyography (EMG', 'higher tidal volumes', 'ITL load']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0581444', 'cui_str': 'Gas mixture'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",13.0,0.023465,"SA,RMS %max  and SM,RMS %max  increased in association with ITL load (p ≤ .01 for both).","[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Basoudan', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, BC, Canada.'}, {'ForeName': 'Antenor', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Physical Therapy, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gallina', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Garland', 'Affiliation': 'Faculty of Health Sciences, Western University, London, ON, Canada.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Guenette', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, BC, Canada.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Shadgan', 'Affiliation': 'International Collaboration on Repair Discoveries, Vancouver, BC, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Road', 'Affiliation': 'Division of Respiratory Medicine, Department of Medicine, University of British Columbia (UBC), Vancouver, BC, Canada.'}, {'ForeName': 'W Darlene', 'Initials': 'WD', 'LastName': 'Reid', 'Affiliation': 'Physical Therapy, University of Toronto, Toronto, ON, Canada.'}]",Physiological reports,['10.14814/phy2.14522']
2871,32729615,Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men.,"BACKGROUND


Altering the temporal distribution of energy intake (EI) and introducing periods of intermittent fasting (IF) exert important metabolic effects. Restricting EI to earlier in the day [early time-restricted feeding (eTRF)] is a novel type of IF.
OBJECTIVES


We assessed the chronic effects of eTRF compared with an energy-matched control on whole-body and skeletal muscle insulin and anabolic sensitivity.
METHODS


Sixteen healthy males (aged 23 ± 1 y; BMI 24.0 ± 0.6 kg·m-2) were assigned to 2 groups that underwent either 2 wk of eTRF (n = 8) or control/caloric restriction (CON:CR; n = 8) diet. The eTRF diet was consumed ad libitum and the intervention was conducted before the CON:CR, in which the diet was provided to match the reduction in EI and body weight observed in eTRF. During eTRF, daily EI was restricted to between 08:00 and 16:00, which prolonged the overnight fast by ∼5 h. The metabolic responses to a carbohydrate/protein drink were assessed pre- and post-interventions following a 12-h overnight fast.
RESULTS


When compared with CON:CR, eTRF improved whole-body insulin sensitivity [between-group difference (95% CI): 1.89 (0.18, 3.60); P = 0.03; η2p = 0.29] and skeletal muscle uptake of glucose [between-group difference (95% CI): 4266 (261, 8270) μmol·min-1·kg-1·180 min; P = 0.04; η2p = 0.31] and branched-chain amino acids (BCAAs) [between-group difference (95% CI): 266 (77, 455) nmol·min-1·kg-1·180 min; P = 0.01; η2p = 0.44]. eTRF caused a reduction in EI (∼400 kcal·d-1) and weight loss (-1.04 ± 0.25 kg; P = 0.01) that was matched in CON:CR (-1.24 ± 0.35 kg; P = 0.01).
CONCLUSIONS


Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake. The metabolic benefits of eTRF are independent of its effects on weight loss and represent chronic adaptations rather than the effect of the last bout of overnight fast. This trial was registered at clinicaltrials.gov as NCT03969745.",2020,"Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake.","['Sixteen healthy males (aged 23\xa0±\xa01 y', 'healthy men']","['early time-restricted feeding (eTRF', 'CON:CR, eTRF', 'eTRF (n\xa0=\xa08) or control/caloric restriction (CON:CR; n\xa0=\xa08) diet', 'eTRF']","['skeletal muscle glucose and BCAA uptake', 'whole-body insulin sensitivity', 'weight loss', 'branched-chain amino acids (BCAAs', 'skeletal muscle insulin and anabolic sensitivity', 'reduction in EI (∼400 kcal·d-1) and weight loss', 'skeletal muscle uptake of glucose']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4704883', 'cui_str': 'Time Restricted Feeding'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0002845', 'cui_str': 'Anabolic steroid'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",16.0,0.0887892,"Under free-living conditions, eTRF improves whole-body insulin sensitivity and increases skeletal muscle glucose and BCAA uptake.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Pardeep', 'Initials': 'P', 'LastName': 'Pabla', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mallinson', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham Medical School, Nottingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa192']
2872,32734691,"Genetic variation in lean body mass, changes of appetite and weight loss in response to diet interventions: The POUNDS Lost trial.","AIM


To investigate whether the genetic risk score (GRS) for lean body mass (LBM) modified the effects of weight-loss diets on changes in appetite and adiposity among overweight and obese individuals.
PARTICIPANTS AND METHODS


In the 2-year Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) trial, we included 692 adults who were randomly assigned to one of four diets varying in macronutrient intake. A GRS was calculated using five single nucleotide polymorphisms associated with LBM.
RESULTS


The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population. We found that the LBM-GRS had significantly different associations with changes in appetite from baseline to 6 months according to low- or high-fat diet group (P-interaction < 0.001, 0.021, 0.005 and 0.024 for total appetite score, hunger, fullness and prospective consumption, respectively). Lower LBM-GRS (indicating a greater genetic predisposition to LBM) was associated with greater decreases in the total appetite score (P < 0.001), hunger (P = 0.01), fullness (P = 0.001) and prospective consumption (P = 0.019) in participants in the low-fat diet group, whereas no significant associations with these appetite measures were observed in the high-fat diet group. In addition, lower LBM-GRS was associated with greater reduction in body weight (P = 0.003) and waist circumference (P = 0.011) among participants in the low-fat diet group, while no associations were observed in the high-fat diet group. The interactions attenuated, along with weight regain, from 6 months to 2 years.
CONCLUSIONS


Our findings suggest that genetic variation in LBM may be differentially associated with appetite changes, and may subsequently be related to changes in body weight and waist circumference, according to dietary fat intake.",2020,The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population.,"['overweight and obese individuals', '692 adults who were randomly assigned to 1 of 4']","['weight-loss diets', 'LBM-GRS', 'diets varying in macronutrient intake']","['appetite and adiposity', 'hunger', 'appetite measures', 'waist circumference', 'fullness', 'body weight', 'total appetite score', 'appetite', 'total appetite score, hunger, fullness, and prospective consumption, respectively', 'genetic risk score (GRS']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",692.0,0.0282244,The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14155']
2873,32732684,Feasibility and Acceptability of Mobile Phone Self-monitoring and Automated Feedback to Enhance Telephone Coaching for People with Risky Substance Use: The QUIT-Mobile Pilot Study.,"OBJECTIVES


This study evaluates the feasibility, acceptability, and perceived benefits of mobile-phone delivered self-monitoring queries and feedback integrated into the evidence-based Quit Using Drugs Intervention Trial (QUIT) screening and brief telephone health coaching intervention to prevent progression from risky drug use to addiction as the QUIT-Mobile intervention.
METHODS


Participants (n = 20) were primarily Black/African American and Latino men in Los Angeles with risky substance use. Self-monitoring surveys were sent by text-message twice-weekly for 6 weeks and once-weekly from 6 to 12-weeks. Surveys consisted of 10 questions regarding drug and alcohol use (ie, # days of use) and cravings, quality of life, and medication adherence. Feedback messages praised or encouraged drug use reductions. Coaches monitored patient responses and discussed them in QUIT's telephone coaching sessions. Participants' experiences were assessed qualitatively at 3-month follow-up.
RESULTS


Nineteen out of 20 participants that completed the qualitative evaluation from the 12-week follow-up reported: (1) self-monitoring surveys helped them adhere to drug use reduction goals and reflect on associations between self-monitoring domains; (2) preference for higher frequency (twice-weekly) self-monitoring during the 6-week coaching period, and then weekly surveys thereafter but not monthly; and (3) self-monitoring and coaching were mutually reinforcing for their drug use reduction goals.
CONCLUSIONS


Results are consistent with prior similar research suggesting that mobile phone self-monitoring of drug use and related factors is feasible and acceptable among diverse adults with risky drug use. Findings also suggest the potential benefits of integrating electronic self-monitoring and feedback into substance use reduction interventions such as QUIT to enhance patient self-management and coaching or counseling intervention components.",2020,"CONCLUSIONS


Results are consistent with prior similar research suggesting that mobile phone self-monitoring of drug use and related factors is feasible and acceptable among diverse adults with risky drug use.","['Nineteen out of 20 participants', 'Participants (n\u200a=\u200a20) were primarily Black/African American and Latino men in Los Angeles with risky substance use', 'People with Risky Substance Use']","['self-monitoring and coaching were mutually reinforcing for their drug use reduction goals', 'mobile-phone delivered self-monitoring queries and feedback integrated into the evidence-based Quit Using Drugs Intervention Trial (QUIT) screening and brief telephone health coaching intervention', 'Mobile Phone Self-monitoring and Automated Feedback to Enhance Telephone Coaching']","['cravings, quality of life, and medication adherence']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",20.0,0.0221036,"CONCLUSIONS


Results are consistent with prior similar research suggesting that mobile phone self-monitoring of drug use and related factors is feasible and acceptable among diverse adults with risky drug use.","[{'ForeName': 'Dallas', 'Initials': 'D', 'LastName': 'Swendeman', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine, University of California, Los Angeles, CA (DS, SS, WSC); Department of Family Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA (EG, LG); Department of Epidemiology, School of Public Health, University of California, Los Angeles, California (PMG, DS).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sumstine', 'Affiliation': ''}, {'ForeName': 'Efren', 'Initials': 'E', 'LastName': 'Aguilar', 'Affiliation': ''}, {'ForeName': 'Pamina M', 'Initials': 'PM', 'LastName': 'Gorbach', 'Affiliation': ''}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Comulada', 'Affiliation': ''}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Gelberg', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000707']
2874,32726899,Effects of a Gluteal Muscles Specific Exercise Program on the Vertical Jump.,"The vertical jump is a complex movement where many factors are involved in the final result. Currently, how a specific exercise program for gluteal muscles can affect the vertical jump is unknown. So, the aim of this study was to examine the effect of a specific exercise program for the gluteal muscles on a vertical jump. Forty-nine amateur athletes completed an 8-week program. The experimental group received a specific gluteal muscle training program in addition to their regular training routine, whereas the control group received their regular training routine. Jump height, flight time, speed and power were assessed (baseline, postintervention, and 4-week follow-up). Repeated-measures analyses of variance were conducted with ∝ ≤ 0.05. We calculated Eta squared effect sizes with 95% confidence intervals. Measurements at 8 weeks revealed significant increases in the experimental group compared to the control group for the values: jump height ( p  < 0.05) (experimental group = 17.15%; control group = 3.09%), flight time ( p  < 0.001) (experimental group = 7.98%; control group = 3.52%), speed ( p  < 0.01) (experimental group = 1.96%; control group = 1.83%) and power ( p  < 0.05) (experimental group = 4.43%; control group = 0.32%). However, at follow-up, these changes were not maintained. These data suggest that this specific training protocol for the gluteal muscles is effective in order to improve vertical jump performance in amateur athletes who use the vertical jump in their routine training habits.",2020,"Measurements at 8 weeks revealed significant increases in the experimental group compared to the control group for the values: jump height ( p  < 0.05) (experimental group = 17.15%; control group = 3.09%), flight time ( p  < 0.001) (experimental group = 7.98%; control group = 3.52%), speed ( p  < 0.01) (experimental group = 1.96%; control group = 1.83%) and power ( p  < 0.05) (experimental group = 4.43%; control group = 0.32%).","['Forty-nine amateur athletes completed an 8-week program', 'amateur athletes who use the vertical jump in their routine training habits']","['specific exercise program', 'Gluteal Muscles Specific Exercise Program', 'specific gluteal muscle training program in addition to their regular training routine, whereas the control group received their regular training routine']","['Jump height, flight time, speed and power', 'vertical jump performance', 'flight time']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",49.0,0.0148403,"Measurements at 8 weeks revealed significant increases in the experimental group compared to the control group for the values: jump height ( p  < 0.05) (experimental group = 17.15%; control group = 3.09%), flight time ( p  < 0.001) (experimental group = 7.98%; control group = 3.52%), speed ( p  < 0.01) (experimental group = 1.96%; control group = 1.83%) and power ( p  < 0.05) (experimental group = 4.43%; control group = 0.32%).","[{'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gallego-Izquierdo', 'Affiliation': 'Physiotherapy and Pain Group, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Vidal-Aragón', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Calderón-Corrales', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Acuña', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Achalandabaso-Ochoa', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain..'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Aibar-Almazán', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain..'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Martínez-Amat', 'Affiliation': 'Department of Health Sciences, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain..'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pecos-Martín', 'Affiliation': 'Physiotherapy and Pain Group, Department of Physical Therapy, University of Alcala, 28801 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17155383']
2875,32734722,"Efficacy of additional tunica vaginalis flap coverage for protecting against urethrocutaneous fistulas in tubularized incised plate urethroplasty: A prospective, randomized controlled trial.","PURPOSE


We compared the protective effect of additional tunica vaginalis flap coverage combined with a dartos flap against urethrocutaneous fistulas in tubularized incised plate (TIP) urethroplasty in a randomized controlled trial.
MATERIALS AND METHODS


This prospective, randomized controlled trial in a single tertiary center enrolled 50 patients in whom it was feasible to perform single TIP urethroplasty between 2016 and 2017. Consecutive children were randomly allocated to study group A (additional tunica vaginalis flap coverage, n=25) or control group B (dartos-only coverage, n=25). All patients were examined in the outpatient clinic at 1, 3, 12, and 24 months. Postoperative cosmetic outcomes were evaluated by surgeons and parents using the Pediatric Penile Perception Scale questionnaire.
RESULTS


In group B, 1 of 25 patients (4.0%) developed an urethrocutaneous fistula within 12 months. An additional two cases of fistula were found in all proximal-type hypospadias patients at 24 months in the same group without statistical significance (p=0.07). The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale.
CONCLUSIONS


Our randomized controlled trial did not show a significant decrease in the incidence of or a significant slowing of the progression of postoperative fistulas after TIP urethroplasty by the use of additional tunica vaginalis coverage. A tunica vaginalis flap is not routinely recommended but could have a selective role in proximal-type TIP urethroplasty with deficient dartos and subcutaneous tissue to cover the neourethra.",2020,"The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale.
","['tubularized incised plate urethroplasty', 'Consecutive children', 'single tertiary center enrolled 50 patients in whom it was feasible to perform single TIP urethroplasty between 2016 and 2017']","['additional tunica vaginalis flap coverage combined with a dartos flap against urethrocutaneous fistulas', 'additional tunica vaginalis flap coverage']","['Pediatric Penile Perception Scale', 'Postoperative cosmetic outcomes', 'penile cosmetic satisfaction rate', 'urethrocutaneous fistula', 'Pediatric Penile Perception Scale questionnaire']","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0228014', 'cui_str': 'Tunica vaginalis structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0689132,"The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale.
","[{'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Han', 'Affiliation': 'Department of Urology, Korea University Ansan Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Song', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Je Seong', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'Sungchan', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Kun Suk', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kskim2@amc.seoul.kr.'}]",Investigative and clinical urology,['10.4111/icu.20200024']
2876,32731960,Cryotherapy With Mobilization Versus Cryotherapy With Mobilization Reinforced With Home Stretching Exercises in Treatment of Chronic Neck Pain: A Randomized Trial.,"OBJECTIVES


The purpose of this study was to compare the effectiveness of cryotherapy with mobilization (CM) vs cryotherapy with mobilization reinforced with home stretching exercises (CMS) on pain and disability.
METHOD


A randomized clinical trial with 2-arm parallel design, concealed allocation, assessor blinding, and intention to-treat analysis. Sixty participants were in 2 groups. Group 1 included cryotherapy with mobilization twice per week for 5 weeks. Group 2 included cryotherapy with mobilization plus home stretching exercises 5 times per week for 5 weeks. The evaluations were at baseline and 2 days posttreatment for the numeric pain rating scale, neck disability index, patient-specific functional scale, and global rating of change.
RESULTS


The CM and CMS decreased neck pain and disability (P = .000). The statistical significance between the groups' differences favored the CM in the numeric pain rating scale, patient-specific functional scale, global rating of change (P = .000), and neck disability index (P = .004).
CONCLUSION


Cryotherapy with mobilization for subjects in this study was more effective in decreasing disability and neck pain than CMS.",2020,"The statistical significance between the groups' differences favored the CM in the numeric pain rating scale, patient-specific functional scale, global rating of change (P = .000), and neck disability index (P = .004).
","['Chronic Neck Pain', 'Sixty participants were in 2 groups']","['Mobilization Reinforced With Home Stretching Exercises', 'Cryotherapy With Mobilization Versus Cryotherapy', 'Cryotherapy with mobilization', 'cryotherapy with mobilization (CM) vs cryotherapy with mobilization reinforced with home stretching exercises (CMS', 'cryotherapy with mobilization plus home stretching exercises', 'cryotherapy with mobilization']","['neck disability index', 'pain and disability', 'disability and neck pain', 'numeric pain rating scale, neck disability index, patient-specific functional scale, and global rating of change', 'numeric pain rating scale, patient-specific functional scale, global rating of change', 'neck pain and disability']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0041718', 'cui_str': 'Centers for Medicare and Medicaid Services'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.0535214,"The statistical significance between the groups' differences favored the CM in the numeric pain rating scale, patient-specific functional scale, global rating of change (P = .000), and neck disability index (P = .004).
","[{'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Lizis', 'Affiliation': 'Department of Physiotherapy, Cracow College of Health Protection, Cracow, Poland. Electronic address: pawel_lizis@poczta.onet.pl.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kobza', 'Affiliation': 'Physiotherapy Laboratory, Żywiec, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Manko', 'Affiliation': 'Department of Ergonomics and Physiology of Physical Effort, Jagiellonian University, Cracow, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Jaszczur-Nowicki', 'Affiliation': 'Department of Tourism, Recreation and Ecology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Perlinski', 'Affiliation': 'Faculty of Health Sciences, University of Humanities and Economy, Elblag, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Para', 'Affiliation': 'Health Protection, Med-On Company, Liszki, Poland.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.11.030']
2877,32735218,Effects of an mHealth Brisk Walking Intervention on Increasing Physical Activity in Older People With Cognitive Frailty: Pilot Randomized Controlled Trial.,"BACKGROUND


Cognitive frailty is the coexistence of physical frailty and cognitive impairment and is an at-risk state for many adverse health outcomes. Moderate-to-vigorous physical activity (MVPA) is protective against the progression of cognitive frailty. Physical inactivity is common in older people, and brisk walking is a feasible form of physical activity that can enhance their MVPA. Mobile health (mHealth) employing persuasive technology has been successful in increasing the levels of physical activity in older people. However, its feasibility and effects on older people with cognitive frailty are unclear.
OBJECTIVE


We aimed to identify the issues related to the feasibility of an mHealth intervention and the trial (ie, recruitment, retention, participation, and compliance) and to examine the effects of the intervention on cognitive function, physical frailty, walking time, and MVPA.
METHODS


An open-label, parallel design, randomized controlled trial (RCT) was employed. The eligibility criteria for the participants were age ≥60 years, having cognitive frailty, and having physical inactivity. In the intervention group, participants received both conventional behavior change intervention and mHealth (ie, smartphone-assisted program using Samsung Health and WhatsApp) interventions. In the control group, participants received conventional behavior change intervention only. The outcomes included cognitive function, frailty, walking time, and MVPA. Permuted block randomization in 1:1 ratio was used. The feasibility issue was described in terms of participant recruitment, retention, participation, and compliance. Wilcoxon signed-rank test was used to test the within-group effects in both groups separately.
RESULTS


We recruited 99 participants; 33 eligible participants were randomized into either the intervention group (n=16) or the control (n=17) group. The median age was 71.0 years (IQR 9.0) and the majority of them were females (28/33, 85%). The recruitment rate was 33% (33/99), the participant retention rate was 91% (30/33), and the attendance rate of all the face-to-face sessions was 100% (33/33). The majority of the smartphone messages were read by the participants within 30 minutes (91/216, 42.1%). ActiGraph (58/66 days, 88%) and smartphone (54/56 days, 97%) wearing compliances were good. After the interventions, cognitive function improvement was significant in both the intervention (P=.003) and the control (P=.009) groups. The increase in frailty reduction (P=.005), walking time (P=.03), step count (P=.02), brisk walking time (P=.009), peak cadence (P=.003), and MVPA time (P=.02) were significant only in the intervention group.
CONCLUSIONS


Our mHealth intervention is feasible for implementation in older people with cognitive impairment and is effective at enhancing compliance with the brisk walking training program delivered by the conventional behavior change interventions. We provide preliminary evidence that this mHealth intervention can increase MVPA time to an extent sufficient to yield clinical benefits (ie, reduction in cognitive frailty). A full-powered and assessor-blinded RCT should be employed in the future to warrant these effects.
TRIAL REGISTRATION


HKU Clinical Trials Registry HKUCTR-2283; http://www.hkuctr.com/Study/Show/31df4708944944bd99e730d839db4756.",2020,"After the interventions, cognitive function improvement was significant in both the intervention (P=.003) and the control (P=.009) groups.","['older people with cognitive impairment', 'participants were age ≥60 years, having cognitive frailty, and having physical inactivity', 'older people with cognitive frailty', 'older people', '99 participants; 33 eligible participants', 'Older People']","['conventional behavior change intervention and mHealth (ie, smartphone-assisted program using Samsung Health and WhatsApp) interventions', 'conventional behavior change intervention', 'ActiGraph', 'mHealth intervention', 'Mobile health (mHealth) employing persuasive technology', 'mHealth Brisk Walking Intervention', 'Moderate-to-vigorous physical activity (MVPA']","['cognitive function, physical frailty, walking time, and MVPA', 'attendance rate', 'cognitive function improvement', 'frailty reduction', 'recruitment rate', 'participant retention rate', 'Physical Activity', 'walking time', 'brisk walking time', 'MVPA time', 'cognitive function, frailty, walking time, and MVPA', 'peak cadence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",33.0,0.0726845,"After the interventions, cognitive function improvement was significant in both the intervention (P=.003) and the control (P=.009) groups.","[{'ForeName': 'Rick Yc', 'Initials': 'RY', 'LastName': 'Kwan', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong (China).'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Daphne Sk', 'Initials': 'DS', 'LastName': 'Cheung', 'Affiliation': 'Centre for Gerontological Nursing, School of Nursing, The Hong Kong Polytechnic University, Hong Kong, Hong Kong (China).'}, {'ForeName': 'Ladda', 'Initials': 'L', 'LastName': 'Thiamwong', 'Affiliation': 'College of Nursing, University of Central Florida, Orlando, FL, United States.'}, {'ForeName': 'Kup-Sze', 'Initials': 'KS', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong (China).'}]",JMIR mHealth and uHealth,['10.2196/16596']
2878,32735221,Effectiveness of a Mobile App Intervention for Anxiety and Depression Symptoms in University Students: Randomized Controlled Trial.,"BACKGROUND


Depression and anxiety symptoms are common among university students, but many do not receive treatment. This is often because of lack of availability, reluctance to seek help, and not meeting the diagnostic criteria required to access services. Internet-based interventions, including smartphone apps, can overcome these issues. However, a large number of apps are available, each with little evidence of their effectiveness.
OBJECTIVE


This study aims to evaluate for the first time the effectiveness of a self-guided mobile app, Feel Stress Free, for the treatment of depression and anxiety symptoms in students.
METHODS


A web-based randomized controlled trial compared a cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control. University students self-identified as experiencing symptoms of anxiety or depression and were randomized to 6 weeks of intervention (n=84) or control (n=84), unblinded. The app is self-guided and incorporates behavioral relaxation activities, mood tracking and thought challenging, and minigames. Participants completed the Hospital Anxiety and Depression Scale online at baseline and every fortnight.
RESULTS


At week 6, the primary end point, there was evidence that the Feel Stress Free app reduced depression symptoms (mean difference -1.56; 95% CI -2.67 to -0.44; P=.006) but only very weak evidence that it reduced anxiety symptoms (mean difference -1.36; 95% CI -2.93 to 0.21; P=.09). At week 4, there was evidence to support the effectiveness of the intervention for anxiety symptoms (mean difference -1.94; 95% CI -3.11 to -0.77; P=.001) and, though weaker, depression symptoms (mean difference -1.08; 95% CI -2.12 to -0.04; P=.04). At week 6, 83% (34/41) of participants indicated that they were using the app weekly or more frequently.
CONCLUSIONS


The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT. Further research is needed to establish its effectiveness at and beyond 6 weeks.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03032952; https://clinicaltrials.gov/ct2/show/NCT03032952.",2020,The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT.,"['depression and anxiety symptoms in students', 'University students self-identified as experiencing symptoms of anxiety or depression', 'University Students', 'university students']","['Mobile App Intervention', 'cognitive behavioral therapy (CBT)-based mobile app Feel Stress Free with a wait-list control']","['anxiety symptoms', 'Hospital Anxiety and Depression Scale online', 'Feel Stress Free app reduced depression symptoms', 'Anxiety and Depression Symptoms', 'depression symptoms']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.247771,The Feel Stress Free app is a promising mobile intervention for treating symptoms of anxiety and depression in students and overcomes many of the barriers to traditional CBT.,"[{'ForeName': 'Tayla', 'Initials': 'T', 'LastName': 'McCloud', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Vaughan', 'Initials': 'V', 'LastName': 'Bell', 'Affiliation': 'Division of Psychology & Language Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Tsakanikos', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}]",JMIR mHealth and uHealth,['10.2196/15418']
2879,32731249,Early Anticoagulation or Antiplatelet Therapy Is Critical in Craniocervical Artery Dissection: Results from the COMPASS Registry.,"INTRODUCTION


Craniocervical artery dissection (CeAD) is a leading cause of stroke in the young patient population. Recent studies reported a low rate of major adverse cardiac events (MACEs) in patients with CeAD, with no significant difference between patients randomized to anticoagulation or antiplatelet therapy.
OBJECTIVE


To compare the effectiveness of anticoagulation and antiplatelet therapy in patients with CeAD.
METHODS


All CeAD patients from 2015 to 2017 were consecutively identified by an electronic medical record-based application and enrolled in this prospective longitudinal registry. CeAD was confirmed by imaging and graded using the Denver scale for blunt cerebrovascular injury. Patients were followed for 12 months for MACE defined as stroke, transient ischemic attack (TIA), or death.
RESULTS


The cohort included 111 CeAD patients (age 53 ± 15.9 years, 56% Caucasian, 50% female). CeAD was detected by magnetic resonance (5%), computed tomography (88%), or catheter angiography (7%). CeAD was noted in the carotid (59%), vertebral (39%), and basilar (2%) arteries, 82% of which were extracranial dissections. CeAD was classified as grade I, II, III, and IV in 16, 33, 19, and 32%, respectively. A total of 40% of dissections were due to known trauma. A predisposing factor was noted in the majority (78%) of patients, including violent sneezing (21%), carrying a heavy load (19%), sports/recreational activity (11%), chiropractic manipulation (9%), abrupt/prolonged rotation of head (9%), and prolonged phone use (9%). At presentation, 41% had a stroke, 5% had TIA, 39% had headache, and 36% were asymptomatic. Favorable outcome defined as a modified Rankin Scale score of 0-2 was noted in 68% at 3 months and 71% at 12 months. The rate of MACEs at 3 and 12 months was 11 and 14%, respectively, with more events observed in patients who were not receiving anticoagulation/antiplatelet therapy due to contraindications (p = 0.008).
CONCLUSIONS


We report diagnostic characteristics, as well as short- and long-term outcomes of CeAD. A high MACE rate was observed within the first 2 weeks of CeAD diagnosis, notably in patients not initiated on anticoagulation or antiplatelet therapy.",2020,Favorable outcome defined as a modified Rankin Scale score of 0-2 was noted in 68% at 3 months and 71% at 12 months.,"['young patient population', 'Craniocervical Artery Dissection', 'patients with CeAD', 'patients with CeAD.\nMETHODS\n\n\nAll CeAD patients from 2015 to 2017 were consecutively identified by an electronic medical record-based application and enrolled in this prospective longitudinal registry', '111 CeAD patients (age 53 ± 15.9 years, 56% Caucasian, 50% female']",['Craniocervical artery dissection (CeAD'],"['headache', 'sports/recreational activity', 'stroke, transient ischemic attack (TIA), or death', 'modified Rankin Scale score of 0-2', 'chiropractic manipulation', 'MACE rate', 'CeAD', 'violent sneezing', 'rate of MACEs']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002949', 'cui_str': 'Dissection of artery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002949', 'cui_str': 'Dissection of artery'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600577', 'cui_str': 'Chiropractic manipulation'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0002949', 'cui_str': 'Dissection of artery'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",111.0,0.0650806,Favorable outcome defined as a modified Rankin Scale score of 0-2 was noted in 68% at 3 months and 71% at 12 months.,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Rosati', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vezzetti', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Kolby T', 'Initials': 'KT', 'LastName': 'Redd', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Brittiny', 'Initials': 'B', 'LastName': 'McMillian', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Giamberardino', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Nishanth', 'Initials': 'N', 'LastName': 'Kodumuri', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Ravish', 'Initials': 'R', 'LastName': 'Kothari', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Anil V', 'Initials': 'AV', 'LastName': 'Yallapragada', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Neurology, Prisma Health Richland, University of South Carolina School of Medicine, Columbia, South Carolina, USA, souvik.sen@uscmed.sc.edu.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000509415']
2880,32735225,Use of a Smartphone App for Weight Loss Versus a Paper-Based Dietary Diary in Overweight Adults: Randomized Controlled Trial.,"BACKGROUND


Mobile health (mHealth) tools may be useful platforms for dietary monitoring and assessment.
OBJECTIVE


This study aims to evaluate the effectiveness of a mobile dietary self-monitoring app for weight loss versus a paper-based diary among adults with a BMI of 23 kg/m 2  or above.
METHODS


A total of 33 men and 17 women aged 18-39 years participated in a 6-week randomized controlled trial. We randomly assigned participants to one of two groups: (1) a smartphone app group (n=25) or (2) a paper-based diary group (n=25). The smartphone app group recorded foods and dietary supplements that they consumed and received immediate dietary feedback using Well-D, a dietary self-monitoring app developed by our team. The paper-based diary group was instructed to record foods or supplements that they consumed using a self-recorded diary. The primary outcomes were weight, BMI, waist circumference, body fat mass, and skeletal muscle mass. We also examined changes in nutrient intake, including energy, carbohydrate, protein, fat, dietary fiber, vitamins, and minerals, using 3-day 24-hour recalls. Differences in changes between the two groups were analyzed using independent t tests or Wilcoxon Mann-Whitney tests. All of the data were analyzed using intent-to-treat analysis.
RESULTS


The mean number of days recorded was 18.5 (SD 14.1) for the app group and 15.5 (SD 10.1) for the paper-based diary group. The differences in changes in weight, BMI, and waist circumference were not significantly different between the app group and paper-based diary group (P=.33, .34, and .70, respectively). Similarly, changes in body fat mass or skeletal muscle mass did not differ between the two groups (P=.71 and .054, respectively). Although energy intake was reduced in both groups, there was no significant difference in changes in energy intake between the two groups (P=.98).
CONCLUSIONS


There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group. Both mobile dietary self-monitoring app and paper-based diary may be useful for improving anthropometric measures.
TRIAL REGISTRATION


Clinical Research Information Service KCT0003170; https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=11642&ltype=&rtype=.",2020,There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group.,"['Overweight Adults', '33 men and 17 women aged 18-39 years', 'adults with a BMI of 23 kg/m 2  or above']","['smartphone app group (n=25) or (2) a paper-based diary group', 'Smartphone App', 'smartphone app group recorded foods and dietary supplements that they consumed and received immediate dietary feedback using Well-D, a dietary self-monitoring app developed by our team', 'mobile dietary self-monitoring app']","['weight, BMI, waist circumference, body fat mass, and skeletal muscle mass', 'weight, BMI, and waist circumference', 'Weight Loss', 'nutrient intake, including energy, carbohydrate, protein, fat, dietary fiber, vitamins, and minerals, using 3-day 24-hour recalls', 'anthropometric measures and nutrient intake', 'body fat mass or skeletal muscle mass', 'weight loss', 'mean number of days recorded', 'energy intake']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",33.0,0.148849,There were no differences in changes in anthropometric measures and nutrient intake between the app group and the paper-based diary group.,"[{'ForeName': 'Jeong Sun', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Heejin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Jiae', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Platform Development Team, Bluecore, Seoul, Republic of Korea.'}, {'ForeName': 'Haemin', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Platform Development Team, Bluecore, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Home Economics, Korea National Open University, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/14013']
2881,32732334,Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging.,"The EarlyCDT-Lung test is a high specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. Here we report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent CT scanning to identify those at high risk of lung cancer reduces the incidence of patients with stage III/IV/Unspecified lung cancer at diagnosis, compared with the standard clinical practice at the time the study began.ECLS was a randomised controlled trial of 12 208 participants at risk of developing lung cancer in Scotland. The intervention arm received the EarlyCDT-Lung test and, if test positive, low-dose CT scanning six-monthly for up to 2 years. EarlyCDT-Lung test negative and control arm participants received standard clinical care. Outcomes were assessed at 2 years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities.At 2 years, 127 lung cancers were detected in the study population (1.0%).In the intervention arm, 33/56 (58.9%) lung cancers were diagnosed at stage III/IV compared to 52/71 (73.2%) in the control arm. The hazard ratio for stage III/IV presentation was 0.64 (95% confidence interval 0.41, 0.99). There were non-significant differences in lung cancer and all-cause mortality after 2 years.ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation), and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage-shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of LDCT.",2020,The hazard ratio for stage III/IV presentation was 0.64,"['12\u200a208 participants at risk of developing lung cancer in Scotland', 'patients with stage III/IV/Unspecified lung cancer at diagnosis']","['standard clinical care', 'EarlyCDT-Lung test and any subsequent CT scanning', 'EarlyCDT-Lung test and, if test positive, low-dose CT scanning six-monthly for up to 2\u2005years', 'ECLS compared EarlyCDT-Lung plus CT screening', 'ECLS']","['lung cancer and all-cause mortality', 'cancer occurrence, cancer staging, mortality and comorbidities', 'hazard ratio for stage III/IV presentation']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",12208.0,0.0525652,The hazard ratio for stage III/IV presentation was 0.64,"[{'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, United Kingdom fms20@st-andrews.ac.uk.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Anderson', 'Affiliation': 'Respiratory Medicine, NHS Tayside, Dundee, United Kingdom.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Armory', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research & Policy, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Chew', 'Affiliation': 'Radiology, NHS Lanarkshire, Bothwell, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Dorward', 'Affiliation': 'Respiratory Medicine, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haughney', 'Affiliation': 'General Practice, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Hogarth', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Saint Lucia, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McCowan', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mcmeekin', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Respiratory Medicine, NHS Lanarkshire, Bothwell, United Kingdom.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rauchhaus', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Ritchie', 'Affiliation': 'The Institute of Applied Health Sciences, University of Aberdeen, Glasgow, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Robertson', 'Affiliation': 'Department of Mathematics and Statistics, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Robles-Zurita', 'Affiliation': 'Institute of Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sarvesvaran', 'Affiliation': 'Respiratory Medicine, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Sewell', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sproule', 'Affiliation': 'Radiology, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Radiology, NHS Tayside, Dundee, United Kingdom.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Tello', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, United Kingdom.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Schembri', 'Affiliation': 'Respiratory Medicine, NHS Tayside, Dundee, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.00670-2020']
2882,32731259,A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study.,"Bruton tyrosine kinase (BTK) inhibition is an effective treatment approach for patients with Waldenström macroglobulinemia (WM). The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel highly selective BTK inhibitor, in patients with WM. Patients with MYD88L265P disease were randomly assigned 1:1 to treatment with ibrutinib or zanubrutinib. The primary end point was the proportion of patients achieving a complete response (CR) or a very good partial response (VGPR) by independent review. Key secondary end points included major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease burden, and safety. A total of 201 patients were randomized, and 199 received ≥1 dose of study treatment. No patient achieved a CR. Twenty-nine (28%) zanubrutinib patients and 19 (19%) ibrutinib patients achieved a VGPR, a nonstatistically significant difference (P = .09). MRRs were 77% and 78%, respectively. Median DOR and PFS were not reached; 84% and 85% of ibrutinib and zanubrutinib patients were progression free at 18 months. Atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia, as well as adverse events leading to treatment discontinuation, were less common among zanubrutinib recipients. Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events per 100 person-months). These results demonstrate that zanubrutinib and ibrutinib are highly effective in the treatment of WM, but zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity.",2020,"Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events/100 person-months).","['201 patients', 'Patients with MYD88L265P disease', 'patients with Waldenström macroglobulinemia (WM', 'patients with WM']","['Bruton tyrosine kinase (BTK) inhibition', 'ibrutinib or zanubrutinib']","['major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease burden, and safety', 'Incidence of atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia', 'proportion of patients achieving a complete or very good partial response (CR or VGPR', 'grade ≥3 infection rates', 'MRRs', 'response quality and less toxicity, particularly cardiovascular toxicity', 'Median DOR and PFS', 'efficacy and safety', 'Incidence of neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024419', 'cui_str': ""Waldenstrom's macroglobulinemia""}]","[{'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C4683810', 'cui_str': 'zanubrutinib'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",201.0,0.0497721,"Incidence of neutropenia was higher with zanubrutinib, although grade ≥3 infection rates were similar in both arms (1.2 and 1.1 events/100 person-months).","[{'ForeName': 'Constantine S', 'Initials': 'CS', 'LastName': 'Tam', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Opat', 'Affiliation': 'Monash Health, Clayton, VIC, Australia.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': ""D'Sa"", 'Affiliation': 'University College London Hospital Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Krakow, Poland.'}, {'ForeName': 'Hui-Peng', 'Initials': 'HP', 'LastName': 'Lee', 'Affiliation': 'Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Cull', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Marlton', 'Affiliation': 'Department of Haematology, Princess Alexandra Hospital, Brisbane, QLD, Australia.'}, {'ForeName': 'Björn E', 'Initials': 'BE', 'LastName': 'Wahlin', 'Affiliation': 'Unit of Hematology, Department of Medicine, Karolinska Universitetssjukhuset-Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ramón Garcia', 'Initials': 'RG', 'LastName': 'Sanz', 'Affiliation': 'Hospital Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth and Christchurch Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Mulligan', 'Affiliation': 'Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Castillo', 'Affiliation': 'Bing Center for Waldenstrom Macroglobulinemia, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Czyz', 'Affiliation': 'Szpital Uniwersytecki No 2 im Dr Jana Biziela, Bydgoszcz, Poland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández de Larrea', 'Affiliation': 'Amyloidosis and Myeloma Unit, Department of Hematology, Hospital Clinic of Barcelona, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Fourth Department of Internal Medicine - Haematology, Charles University Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Libby', 'Affiliation': 'Department of Medicine, University of Washington and the Seattle Cancer Care Alliance, Seattle, WA.'}, {'ForeName': 'Jeffrey V', 'Initials': 'JV', 'LastName': 'Matous', 'Affiliation': 'Colorado Blood Cancer Institute, Denver, CO.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Motta', 'Affiliation': 'ASST Spedali Civili di Brescia, Lombardia, Italy.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Siddiqi', 'Affiliation': 'City of Hope National Medical Center, Duarte, CA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Ospedale Civile S Maria delle Croci, Azienda Unità Sanitaria Locale (AUSL), Ravenna, Italy.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trneny', 'Affiliation': 'First Department of Medicine, First Faculty of Medicine, Charles University, General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Monique C', 'Initials': 'MC', 'LastName': 'Minnema', 'Affiliation': 'University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Buske', 'Affiliation': 'Comprehensive Cancer Center Ulm-Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': ""Service d'Hématologie Clinique, Sorbonne University, Pitié Salpêtrière Hospital, Paris, France.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trotman', 'Affiliation': 'Haematology Department, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Wai Y', 'Initials': 'WY', 'LastName': 'Chan', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Ro', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'BeiGene USA, Inc, San Mateo, CA; and.'}, {'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.'}]",Blood,['10.1182/blood.2020006844']
2883,32744512,Hepatitis B core-related antigen levels predict pegylated interferon-α therapy response in HBeAg-positive chronic hepatitis B.,"BACKGROUND


Serum hepatitis B core-related antigen (HBcrAg) levels reflect intrahepatic HBV replication activity. We aimed to study whether HBcrAg levels predict response to pegylated interferon (PEG-IFN) treatment in hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) patients.
METHODS


We studied HBcrAg levels in 222 HBeAg-positive patients treated with PEG-IFN with or without lamivudine for 52 weeks in a global randomized trial and compared kinetics across treatment arms and types of response. Optimal HBcrAg cutoffs for stopping therapy were compared to and combined with the currently recommended hepatitis B surface antigen (HBsAg)-based stopping-rules.
RESULTS


Baseline HBcrAg levels could not discriminate between responders and non-responders (P=0.91). HBcrAg levels of patients responding to PEG-IFN therapy showed a more pronounced on-treatment decline (mean declines 3.4 versus 1.0 log U/ml; P<0.0001), which was sustained until the end of follow-up (mean declines week 78, 3.8 versus 1.0 log U/ml; P<0.0001). In the PEG-IFN monotherapy group, HBcrAg levels of >8.35 log U/ml at week 24 identified 19 patients (19%) of whom 1 (negative predicitve value [NPV]=95%) achieved a response. The performance of this HBcrAg-based stopping rule alone was not superior to the one based on HBsAg >20,000 IU/ml. Among patients with an HBsAg <20,000 (n=56), 9 (16%) had an HBcrAg >8.35, of whom 8 achieved no response (NPV 89%).
CONCLUSIONS


HBeAg-positive CHB patients with a response to PEG-IFN therapy achieve a more pronounced HBcrAg decline. HBcrAg levels at week 24 of therapy could be used to identify non-responders in combination with the established HBsAg-based stopping-rules.",2020,"The performance of this HBcrAg-based stopping rule alone was not superior to the one based on HBsAg >20,000 IU/mL. Among patients with an HBsAg <20,000 (n=56), 9 (16%) had an HBcrAg >8.35, of whom 8 achieved no response (NPV 89%).
","['222 HBeAg-positive patients treated with', 'HBeAg positive chronic hepatitis B (CHB) patients', 'HBeAg-positive chronic hepatitis B']","['PEG-IFN with or without lamivudine', 'peginterferon (PEG-IFN']",['treatment decline'],"[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}]","[{'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0695603,"The performance of this HBcrAg-based stopping rule alone was not superior to the one based on HBsAg >20,000 IU/mL. Among patients with an HBsAg <20,000 (n=56), 9 (16%) had an HBcrAg >8.35, of whom 8 achieved no response (NPV 89%).
","[{'ForeName': 'Boris Jb', 'Initials': 'BJ', 'LastName': 'Beudeker', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Zwier Ma', 'Initials': 'ZM', 'LastName': 'Groothuismink', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'de Man', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Harry LA', 'Initials': 'H', 'LastName': 'Janssen', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Annemiek A', 'Initials': 'AA', 'LastName': 'van der Eijk', 'Affiliation': 'Department of Viroscience, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Boonstra', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Milan J', 'Initials': 'MJ', 'LastName': 'Sonneveld', 'Affiliation': 'Department of Gastroenterology & Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}]",Antiviral therapy,['10.3851/IMP3367']
2884,32737993,Clinical trial readiness study of distal myopathy and dysphagia in nephropathic cystinosis.,"BACKGROUND


Nephropathic cystinosis is a lysosomal storage disorder with late-onset systemic complications, such as myopathy and dysphagia. Currently employed outcome measures lack sensitivity and responsiveness for dysphagia and myopathy, a limitation to clinical trial readiness.
METHODS


We evaluated 20 patients with nephropathic cystinosis in two visits over the course of a year to identify outcomes sensitive to detect changes over time. Patients also underwent an expiratory muscle strength training program to assess any effects on aspiration and dysphagia.
RESULTS


There were significant differences in the Timed Up and Go Test (TUG) and Timed 25-Foot Walk (25-FW) between baseline and 1-y follow-up (P < .05). Maximum expiratory pressure (MEP) and peak cough flow (PCF) significantly improved following respiratory training (P < .05).
CONCLUSIONS


Improved respiratory outcomes may enhance patients ability to expel aspirated material from the airway, stave off pulmonary sequelae associated with chronic aspiration, and yield an overall improvement in physical health and well-being.",2020,"Maximum Expiratory Pressure (MEP) and Peak Cough Flow (PCF) significantly improved following respiratory training (p < 0.05).
","['Distal Myopathy and Dysphagia in Nephropathic Cystinosis', '20 patients with nephropathic cystinosis in two visits over the course of a year']",['expiratory muscle strength training program'],"['Timed Up and Go Test (TUG) and Timed 25-Foot Walk (25-FW', 'Maximum Expiratory Pressure (MEP) and Peak Cough Flow (PCF']","[{'cui': 'C0751336', 'cui_str': 'Distal muscular dystrophy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0015624', 'cui_str': 'Fanconi syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",20.0,0.0494736,"Maximum Expiratory Pressure (MEP) and Peak Cough Flow (PCF) significantly improved following respiratory training (p < 0.05).
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sadjadi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Department of Speech, Language and Swallowing Disorders, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grant', 'Affiliation': 'Center for Rare Neurological Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Thomas', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics and Communicable Diseases, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Doyle', 'Affiliation': 'Department of Social Work, School of Health Sciences, Quinnipiac University, Hamden, Connecticut, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Hammond', 'Affiliation': 'Cystinosis Adult Care Excellence Initiative, Reading, Massachusetts, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Corre', 'Affiliation': 'Center for Rare Neurological Diseases, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Mello', 'Affiliation': 'Center for Rare Neurological Diseases, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'David', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Eichler', 'Affiliation': 'Center for Rare Neurological Diseases, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Muscle & nerve,['10.1002/mus.27039']
2885,32744221,Targeting fear of positive evaluation in patients with social anxiety disorder via a brief cognitive behavioural therapy protocol: a proof-of-principle study.,"BACKGROUND


Our aim was to develop a brief cognitive behavioural therapy (CBT) protocol to augment treatment for social anxiety disorder (SAD). This protocol focused specifically upon fear of positive evaluation (FPE). To our knowledge, this is the first protocol that has been designed to systematically target FPE.
AIMS


To test the feasibility of a brief (two-session) CBT protocol for FPE and report proof-of-principle data in the form of effect sizes.
METHOD


Seven patients with a principal diagnosis of SAD were recruited to participate. Following a pre-treatment assessment, patients were randomized to either (a) an immediate CBT condition (n = 3), or (b) a comparable wait-list (WL) period (2 weeks; n = 4). Two WL patients also completed the CBT protocol following the WL period (delayed CBT condition). Patients completed follow-up assessments 1 week after completing the protocol.
RESULTS


A total of five patients completed the brief, FPE-specific CBT protocol (two of the seven patients were wait-listed only and did not complete delayed CBT). All five patients completed the protocol and provided 1-week follow-up data. CBT patients demonstrated large reductions in FPE-related concerns as well as overall social anxiety symptoms, whereas WL patients demonstrated an increase in FPE-related concerns.
CONCLUSIONS


Our brief FPE-specific CBT protocol is feasible to use and was associated with large FPE-specific and social anxiety symptom reductions. To our knowledge, this is the first treatment report that has focused on systematic treatment of FPE in patients with SAD. Our protocol warrants further controlled evaluation.",2020,"CBT patients demonstrated large reductions in FPE-related concerns as well as overall social anxiety symptoms, whereas WL patients demonstrated an increase in FPE-related concerns.
","['Seven patients with a principal diagnosis of SAD were recruited to participate', 'patients with social anxiety disorder via a brief', 'patients with SAD', 'social anxiety disorder (SAD']","['CBT', 'FPE', 'cognitive behavioural therapy protocol', 'immediate CBT condition', 'FPE-specific CBT protocol', 'cognitive behavioural therapy (CBT) protocol']","['FPE-related concerns', 'overall social anxiety symptoms']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",7.0,0.0246387,"CBT patients demonstrated large reductions in FPE-related concerns as well as overall social anxiety symptoms, whereas WL patients demonstrated an increase in FPE-related concerns.
","[{'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Weeks', 'Affiliation': 'Nebraska Medicine, Department of Psychology, University of Nebraska Medical Center, Department of Psychiatry, Omaha, NE68198-4185, USA.'}, {'ForeName': 'M Taylor', 'Initials': 'MT', 'LastName': 'Wilmer', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Carrie M', 'Initials': 'CM', 'LastName': 'Potter', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Waldron', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Versella', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Simona C', 'Initials': 'SC', 'LastName': 'Kaplan', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Dane', 'Initials': 'D', 'LastName': 'Jensen', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Heimberg', 'Affiliation': 'Adult Anxiety Clinic of Temple, Temple University, Philadelphia, PA, USA.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000491']
2886,32743591,Safety of Hydroxychloroquine among Outpatient Clinical Trial Participants for COVID-19.,"INTRODUCTION


Use of hydroxychloroquine in hospitalized patients with COVID-19, especially in combination with azithromycin, has raised safety concerns. Here, we report safety data from three outpatient randomized clinical trials.
METHODS


We conducted three randomized, double-blind, placebo-controlled trials investigating hydroxychloroquine as pre-exposure prophylaxis, post-exposure prophylaxis and early treatment for COVID-19. We excluded individuals with contraindications to hydroxychloroquine. We collected side effects and serious adverse events. We report descriptive analyses of our findings.
RESULTS


We enrolled 2,795 participants. The median age of research participants was 40 (IQR 34-49) years, and 59% (1633/2767) reported no chronic medical conditions. Overall 2,324 (84%) participants reported side effect data, and 638 (27%) reported at least one medication side effect. Side effects were reported in 29% with daily, 36% with twice weekly, 31% with once weekly hydroxychloroquine compared to 19% with placebo. The most common side effects were upset stomach or nausea (25% with daily, 18% with twice weekly, 16% with weekly, vs. 10% for placebo), followed by diarrhea, vomiting, or abdominal pain (23% for daily, 16% twice weekly, 12% weekly, vs. 6% for placebo). Two individuals were hospitalized for atrial arrhythmias, one on placebo and one on twice weekly hydroxychloroquine. No sudden deaths occurred.
CONCLUSION


Data from three outpatient COVID-19 trials demonstrated that gastrointestinal side effects were common but mild with the use of hydroxychloroquine, while serious side effects were rare. No deaths occurred related to hydroxychloroquine. Randomized clinical trials can safely investigate whether hydroxychloroquine is efficacious for COVID-19.",2020,No deaths occurred related to hydroxychloroquine.,"['hospitalized patients with COVID-19', 'Two individuals were hospitalized for atrial arrhythmias, one on', 'We enrolled 2,795 participants']","['placebo', 'azithromycin', 'Hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'sudden deaths', 'gastrointestinal side effects', 'diarrhea, vomiting, or abdominal pain', 'deaths', 'upset stomach or nausea']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0235309', 'cui_str': 'Upset stomach'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",2795.0,0.557474,No deaths occurred related to hydroxychloroquine.,"[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': ''}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': ''}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': ''}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': ''}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': ''}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': ''}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': ''}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': ''}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': ''}, {'ForeName': 'Darlisha A', 'Initials': 'DA', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': ''}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Axelrod', 'Affiliation': ''}, {'ForeName': 'Sylvian A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': ''}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': ''}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': ''}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanshi', 'Affiliation': ''}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': ''}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Chagla', 'Affiliation': ''}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Katherine Huppler', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': ''}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2020.07.16.20155531']
2887,32743999,[The effect of transcranial direct current stimulation on dysfunction of bilateral posterior cingulate cortex after sleep deprivation: a preliminary study].,"Objective:  To investigate the effects of transcranial direct current stimulation (tDCS) on the disturbance of brain network dysfunction after sleep deprivation (SD).  Methods:  The experimental design of self-control was used in the study. All 16 subjects received 2 times of 24 h SD with an interval of 3 weeks. After the first normal sleep, 24 h SD and transcranial electrical stimulation (true or false stimulation) intervention (the current magnitude of true and false stimulation was 1 mA, and the action time was 20 min and 2 s, respectively. The intervention experiment lasted for 20 min. ) and the resting magnetic resonance imaging data were collected after the second transcranial electrical stimulation (sham or true stimulation). The resting fMRI data were collected as baseline before SD, the bilateral posterior cingulate cortex in the default mode network was selected as the seed point, and the functional connectivity between the seed points and the whole brain was calculated.  Results:  Compared with the rest wakefulness, the functional connectivity among bilateral posterior cingulate cortex, bilateral thalamus and hippocampus was increased ( P ＜0. 01), but connected with the right precuneus, bilateral insula was decreased after 24 h SD ( P ＜0. 01). Compared with the sham tDCS group, the functional connectivity between left posterior cingulate cortex seed point and right precuneus of tDCS group was increased ( P ＜0. 01); but decreased with the bilateral thalamus, insula and right cerebral cortex ( P ＜0. 01). There was a decrease in the functional connectivity among the right posterior cingulate cortex and the bilateral thalamus, right insula, and cerebral cortex( P ＜0. 01).  Conclusion:  24-hours sleep deprivation can cause functional connection disorder of bilateral posterior cingulate gyrus, and transcranial electrical stimulation can improve the functional connection disorder after sleep deprivation to some extent.",2020,"Compared with the sham tDCS group, the functional connectivity between left posterior cingulate cortex seed point and right precuneus of tDCS group was increased ( P ＜0.",[],"['transcranial direct current stimulation (tDCS', 'sham tDCS', 'transcranial direct current stimulation', 'transcranial electrical stimulation (sham or true stimulation', 'transcranial electrical stimulation (true or false stimulation) intervention', 'transcranial electrical stimulation']","['bilateral thalamus, insula and right cerebral cortex', 'resting fMRI data', 'bilateral thalamus, right insula, and cerebral cortex', 'functional connectivity among bilateral posterior cingulate cortex, bilateral thalamus and hippocampus', 'functional connectivity between left posterior cingulate cortex seed point and right precuneus', 'functional connectivity']",[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0455803', 'cui_str': 'Transcranial electrical stimulation'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate Gyri'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]",,0.0365165,"Compared with the sham tDCS group, the functional connectivity between left posterior cingulate cortex seed point and right precuneus of tDCS group was increased ( P ＜0.","[{'ForeName': 'Qing-Qing', 'Initials': 'QQ', 'LastName': 'Meng', 'Affiliation': ""Department of Geriatric Neurology, Sleep Medicine Research Center, the General Hospital of the People's Liberation Army, Beijing 100853.""}, {'ForeName': 'Ji-Yuan', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'Department of MRI, Beijing Shijitan Hospital Capital Medical University, Beijing 100038.'}, {'ForeName': 'Da-Long', 'Initials': 'DL', 'LastName': 'Guo', 'Affiliation': 'Air Force Institute of Aviation Medicine, Aviation Medical Engineering Research Center, Beijing 100037.'}, {'ForeName': 'Yong-Cong', 'Initials': 'YC', 'LastName': 'Shao', 'Affiliation': 'Beijing Institute of Basic Medical Sciences, Cognitive and Mental Health Research Center, Beijing 100850, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Geriatric Neurology, Sleep Medicine Research Center, the General Hospital of the People's Liberation Army, Beijing 100853.""}]",Zhongguo ying yong sheng li xue za zhi = Zhongguo yingyong shenglixue zazhi = Chinese journal of applied physiology,['10.12047/j.cjap.5886.2020.023']
2888,32732336,Spontaneous clearance of genital and extragenital  Neisseria gonorrhoeae : data from GToG.,"OBJECTIVES


Neisseria gonorrhoeae  (NG) infection can resolve without antibiotic treatment, however the literature describing the frequency of clearance at individual sites, how rapidly it occurs and potential predictive factors is limited. In this analysis of a subpopulation identified from a large multicentre UK cohort, we describe the overall rate of spontaneous clearance of infection and explore factors associated with this.
METHODS


Data from the Gentamicin compared with Ceftriaxone for the Treatment of Gonorrhoea randomised controlled trial consisting of 720 patients with NG were analysed. A subgroup of individuals had both a pretrial test sample and a trial enrolment sample taken. Those who had cleared NG between initial presentation and subsequent entry into the trial without antibiotic treatment were deemed to have spontaneously cleared. Sociodemographic characteristics, sexual history and sites of infection for those who spontaneously cleared infection were compared with that of those who did not. We also estimated the time interval to clearance.
RESULTS


Overall, the proportion who had spontaneous clearance was 20.5% (83/405). Clearance of infection occurred over a median of 10 days (IQR 7-15 days). The cohort who spontaneously cleared were similar to those who did not in terms of age, gender, sexual orientation, HIV status and previous NG infection. Chlamydia coinfection was more frequent in the 'no spontaneous clearance group' (11.1% (9/83) cf 22.0% (69/322)) (p=0.029). Dysuria was reported more often in the 'no spontaneous clearance group' (4.8% (4/83) cf 13.0% (42/322)) (p=0.035).
CONCLUSION


We present data from a large cohort of NG-infected individuals, of whom a significant proportion had spontaneous clearance of infection. This is consistent with previous smaller studies. If this is indicative of cure, point-of-care testing prior to treatment has the potential to reduce unnecessary exposure to antimicrobials. Further work to assess the importance of bacterial load, genotype and host immune response on spontaneous clearance of infection is required.
TRIAL REGISTRATION NUMBER


ISRCTN51783227.",2020,"The cohort who spontaneously cleared were similar to those who did not in terms of age, gender, sexual orientation, HIV status and previous NG infection.",['720 patients with NG were analysed'],"['Ceftriaxone', 'Gentamicin']","['Sociodemographic characteristics, sexual history and sites of infection', 'spontaneous clearance of infection', 'Clearance of infection', 'spontaneous clearance', 'Dysuria', 'Chlamydia coinfection', 'time interval to clearance']","[{'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0017436', 'cui_str': 'Gentamycins'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",720.0,0.139926,"The cohort who spontaneously cleared were similar to those who did not in terms of age, gender, sexual orientation, HIV status and previous NG infection.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mensforth', 'Affiliation': 'Department of Sexual Health and HIV, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK sarahmensforth@nhs.net.'}, {'ForeName': 'Oluseyi Cyril', 'Initials': 'OC', 'LastName': 'Ayinde', 'Affiliation': 'Department of Sexual Health and HIV, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'Department of Sexual Health and HIV, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]",Sexually transmitted infections,['10.1136/sextrans-2020-054500']
2889,32739331,Which brand should be more nervous about nutritional information disclosure: McDonald's or Subway?,"This study examines the health halo and horn effects in the context of two fast food brands commonly associated with healthy and unhealthy food (i.e., Subway and McDonald's). Health halo is consumers' tendency to overestimate the healthiness of certain food categories or items based on a single claim, whereas health horn is the tendency to underestimate it. Specifically, we investigated the moderating effects of nutritional information disclosure and dietary restraint on consumers' behavioral intentions. Two items from the McDonald's and Subway menus each served as stimuli. They represented health halo confirmation (Roast Chicken sandwich) or disconfirmation (Italian Spicy sandwich) and health horn confirmation (Big Mac burger) or disconfirmation (McSpicy Cajun Burger). This study employed a 2 (nutritional information: present vs. absent) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) mixed factorial design. Participants were randomly assigned to one of two experimental conditions (nutritional information: present vs. absent) and presented with all four menu items. There was a decrease in behavioral intentions toward all menu items except the one representing health horn disconfirmation. In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich). The findings not only delineate the different practices companies adopt but also underscore the importance of nutritional information disclosure in helping consumers make healthier food choices.",2020,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[""consumers' behavioral intentions""]","[""absent)\u202f×\u202f4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters"", 'nutritional information disclosure and dietary restraint', ""health halo or horn associated with Subway or McDonald's menu items""]",['behavioral intentions'],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524709', 'cui_str': 'Subways'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0167676,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[{'ForeName': 'Meeyoung', 'Initials': 'M', 'LastName': 'Joe', 'Affiliation': 'Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 505, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: cookie22@yonsei.ac.kr.'}, {'ForeName': 'Seoki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Hospitality Management, The Pennsylvania State University, 217 Mateer Building University Park, PA, 16802, USA. Electronic address: leeseoki@psu.edu.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Dept. of Food & Nutrition, Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 510, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: sham2@yonsei.ac.kr.'}]",Appetite,['10.1016/j.appet.2020.104805']
2890,32739962,"Transversus Abdominis Plane Block With Liposomal Bupivacaine for Pain After Cesarean Delivery in a Multicenter, Randomized, Double-Blind, Controlled Trial.","BACKGROUND


In women undergoing cesarean delivery under spinal anesthesia with intrathecal morphine, transversus abdominis plane (TAP) block with bupivacaine hydrochloride (HCl) may not improve postsurgical analgesia. This lack of benefit could be related to the short duration of action of bupivacaine HCl. A retrospective study reported that TAP block with long-acting liposomal bupivacaine (LB) reduced opioid consumption and improved analgesia following cesarean delivery. Therefore, we performed a prospective multicenter, randomized, double-blind trial examining efficacy and safety of TAP block with LB plus bupivacaine HCl versus bupivacaine HCl alone.
METHODS


Women (n = 186) with term pregnancies undergoing elective cesarean delivery under spinal anesthesia were randomized (1:1) to TAP block with LB 266 mg plus bupivacaine HCl 50 mg or bupivacaine HCl 50 mg alone. Efficacy was evaluated in a protocol-compliant analysis (PCA) set that was defined a priori. The primary end point was total postsurgical opioid consumption (oral morphine equivalent dosing [MED]) through 72 hours. Pain intensity was measured using a visual analog scale. Adverse events (AEs) after treatment were recorded through day 14.
RESULTS


Total opioid consumption through 72 hours was reduced with LB plus bupivacaine HCl versus bupivacaine HCl alone (least squares mean [LSM] [standard error (SE)] MED, 15.5 mg [6.67 mg] vs 32.0 mg [6.25 mg]). This corresponded to an LSM treatment difference of -16.5 mg (95% confidence interval [CI], -30.8 to -2.2 mg; P = .012). The area under the curve of imputed pain intensity scores through 72 hours supported noninferiority of LB plus bupivacaine HCl versus bupivacaine HCl alone (LSM [SE], 147.9 [21.13] vs 178.5 [19.78]; LSM treatment difference, -30.6; 95% CI, -75.9 to 14.7), with a prespecified noninferiority margin of 36 (P = .002). In an analysis of all treated patients, including those not meeting criteria for inclusion in the PCA, there was no difference in postsurgical opioid consumption between groups. In the LB plus bupivacaine HCl group, 63.6% of patients experienced an AE after treatment versus 56.2% in the bupivacaine HCl-alone group. Serious AEs after treatment were rare (≈3% in both groups).
CONCLUSIONS


TAP block using LB plus bupivacaine HCl as part of a multimodal analgesia protocol incorporating intrathecal morphine resulted in reduced opioid consumption after cesarean delivery in the PCA set. Results suggest that with correct TAP block placement and adherence to a multimodal postsurgical analgesic regimen, there is an opioid-reducing benefit of adding LB to bupivacaine TAP blocks after cesarean delivery (ClinicalTrials.gov identifier: NCT03176459).",2020,"RESULTS


Total opioid consumption through 72 hours was reduced with LB plus bupivacaine HCl versus bupivacaine HCl alone (least squares mean [LSM] [standard error (SE)]","['women undergoing cesarean delivery under spinal anesthesia with', 'Women (n = 186) with term pregnancies undergoing elective cesarean delivery under spinal anesthesia']","['intrathecal morphine, transversus abdominis plane (TAP) block with bupivacaine hydrochloride (HCl', 'TAP block with LB plus bupivacaine HCl', 'bupivacaine HCl versus bupivacaine HCl alone (least squares mean [LSM] [standard error (SE', 'bupivacaine HCl', 'bupivacaine HCl versus bupivacaine HCl alone (LSM [SE', 'bupivacaine HCl alone', 'bupivacaine HCl-alone', 'bupivacaine TAP blocks', 'TAP block with long-acting liposomal bupivacaine (LB', 'TAP block with LB 266 mg plus bupivacaine HCl 50 mg or bupivacaine HCl 50 mg alone', 'Liposomal Bupivacaine']","['pain intensity scores', 'Total opioid consumption', 'opioid consumption and improved analgesia', 'Pain', 'Pain intensity', 'postsurgical opioid consumption', 'Efficacy', 'Adverse events (AEs', 'opioid consumption', 'postsurgical analgesia', 'total postsurgical opioid consumption (oral morphine equivalent dosing [MED']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",186.0,0.647685,"RESULTS


Total opioid consumption through 72 hours was reduced with LB plus bupivacaine HCl versus bupivacaine HCl alone (least squares mean [LSM] [standard error (SE)]","[{'ForeName': 'Srdjan S', 'Initials': 'SS', 'LastName': 'Nedeljkovic', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Kett', 'Affiliation': ""Department of Anesthesiology, Saint Peter's University Hospital, New Brunswick, New Jersey.""}, {'ForeName': 'Manuel C', 'Initials': 'MC', 'LastName': 'Vallejo', 'Affiliation': 'Department of Anesthesiology, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Horn', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Carvalho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Naida M', 'Initials': 'NM', 'LastName': 'Cole', 'Affiliation': ""From the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Renfro', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Gadsden', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Habib', 'Affiliation': 'Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005075']
2891,32740218,Direct oral anticoagulants in chronic kidney disease: an update.,"PURPOSE OF REVIEW


Direct oral anticoagulants (DOACs) are variably eliminated by the kidneys rendering their use potentially problematic in patients with chronic kidney disease (CKD) or necessitating appropriate dose adjustment.
RECENT FINDINGS


Both observational and limited randomized trial data for DOACs compared with no treatment or with warfarin for patients with atrial fibrillation on maintenance dialysis were recently published. In a randomized trial in patients on hemodialysis, there was no significant difference in vascular calcification between patients who received rivaroxaban with or without vitamin K2 or vitamin K antagonists. A randomized trial of apixaban versus warfarin was terminated owing to poor enrollment and preliminary results identified no difference in clinical outcomes between groups. However, valuable pharmacodynamic data will be forthcoming from that trial. In observational research, among patients newly diagnosed with atrial fibrillation, there were opposing trends in the associations of apixaban initiation versus no oral anticoagulation with ischemic versus hemorrhagic stroke and no association was present with the overall risk of stroke or embolism. In another study comparing apixaban with warfarin initiation, apixaban was associated with less bleeding. Regular-dose apixaban (5 mg twice daily) associated with reduced rates of ischemic stroke or systemic embolism, whereas no such association was present for those prescribed the reduced dose (2.5 mg twice daily).
SUMMARY


DOACs may be used after appropriate dose adjustment for an established clinical indication in patients with advanced CKD. Quality evidence for oral anticoagulation, with any specific agent or dose, for stroke prevention in hemodialysis continues to be lacking.",2020,"Regular-dose apixaban (5 mg twice daily) associated with reduced rates of ischemic stroke or systemic embolism, whereas no such association was present for those prescribed the reduced dose (2.5 mg twice daily).
","['patients newly diagnosed with atrial fibrillation', 'patients with atrial fibrillation on maintenance dialysis', 'chronic kidney disease', 'patients with chronic kidney disease (CKD) or necessitating appropriate dose adjustment', 'patients with advanced CKD']","['apixaban with warfarin initiation, apixaban', 'apixaban versus warfarin', 'Regular-dose apixaban', 'warfarin', 'rivaroxaban', 'vitamin K2 or vitamin K antagonists', 'Direct oral anticoagulants']","['vascular calcification', 'bleeding', 'overall risk of stroke or embolism', 'rates of ischemic stroke or systemic embolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",,0.0523301,"Regular-dose apixaban (5 mg twice daily) associated with reduced rates of ischemic stroke or systemic embolism, whereas no such association was present for those prescribed the reduced dose (2.5 mg twice daily).
","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Mavrakanas', 'Affiliation': 'Department of Medicine, McGill University, Montreal, QC & Department of Medicine, Geneva University Hospitals & Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Charytan', 'Affiliation': 'Division of Nephrology, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Wolfgang C', 'Initials': 'WC', 'LastName': 'Winkelmayer', 'Affiliation': 'Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, Texas, USA.'}]",Current opinion in nephrology and hypertension,['10.1097/MNH.0000000000000634']
2892,32739320,Reduced Dose Posterior to Prostate Correlates With Increased PSA Progression in Voxel-Based Analysis of 3 Randomized Phase 3 Trials.,"PURPOSE


Reducing margins during treatment planning to decrease dose to healthy organs surrounding the prostate can risk inadequate treatment of subclinical disease. This study aimed to investigate whether lack of dose to subclinical disease is associated with increased disease progression by using high-quality prostate radiation therapy clinical trial data to identify anatomically localized regions where dose variation is associated with prostate-specific antigen progression (PSAP).
METHODS AND MATERIALS


Planned dose distributions for 683 patients of the Trans-Tasman Radiation Oncology Group 03.04 Randomized Androgen Deprivation and Radiotherapy (RADAR) trial were deformably registered onto a single exemplar computed tomography data set. These were divided into high-risk and intermediate-risk subgroups for analysis. Three independent voxel-based statistical tests, using permutation testing, Cox regression modeling, and least absolute shrinkage selection operator feature selection, were applied to identify regions where dose variation was associated with PSAP. Results from the intermediate-risk RADAR subgroup were externally validated by registering dose distributions from the RT01 (n = 388) and Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer Trial (CHHiP) (n = 253) trials onto the same exemplar and repeating the tests on each of these data sets.
RESULTS


Voxel-based Cox regression revealed regions where reduced dose was correlated with increased prostate-specific androgen progression. Reduced dose in regions associated with coverage at the posterior prostate, in the immediate periphery of the posterior prostate, and in regions corresponding to the posterior oblique beams or posterior lateral beam boundary, was associated with increased PSAP for RADAR and RT01 patients, but not for CHHiP patients. Reduced dose to the seminal vesicle region was also associated with increased PSAP for RADAR intermediate-risk patients.
CONCLUSIONS


Ensuring adequate dose coverage at the posterior prostate and immediately surrounding posterior region (including the seminal vesicles), where aggressive cancer spread may be occurring, may improve tumor control. It is recommended that particular care be taken when defining margins at the prostate posterior, acknowledging the trade-off between quality of life due to rectal dose and the preferences of clinicians and patients.",2020,"Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients.
","[""683 patients of the 'Trial-A's name' were deformably registered onto a single exemplar computed tomography (CT) dataset""]",[],['PSA progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}]",,0.0428037,"Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Perth, Western Australia, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Newcastle, New South Wales, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Sydney, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Centre for Medical Radiation Physics, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Newcastle, New South Wales, Australia; CSIRO, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Sydney, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Centre for Medical Radiation Physics, University of Wollongong, Wollongong, New South Wales, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Sydney, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Perth, Western Australia, Australia; 5D Clinics, Claremont, Perth, Western Australia, Australia; GenesisCare WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Perth, Western Australia, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia; 5D Clinics, Claremont, Perth, Western Australia, Australia.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.07.030']
2893,32740283,Preliminary Impact of an Adapted Emotion Regulation Intervention for Adolescents with Overweight and Obesity Attempting to Lose Weight.,"OBJECTIVE


This study examines the acceptability, feasibility, and preliminary impact of a program (HealthTRAC) combining 2 efficacious interventions (one targeting emotion regulation [TRAC] and the other a standardized behavioral weight management intervention [SBWC]) to improve weight management outcomes among a sample of adolescents with overweight and obesity.
METHOD


Adolescents with overweight or obesity (N = 38), ages 13 to 17 years, were enrolled and randomized into either the SBWC or HealthTRAC. Data were collected at baseline (before intervention), at the end of the 16-week intervention (postintervention), and 4 months after completing the intervention (4 months). Assessments included adolescent self-reports of intervention acceptability and reported emotion regulation (ER) abilities and caregiver report of adolescent ER skills. Body mass index (BMI) was used to examine the impact on adolescent weight outcomes. Analyses of covariance controlling for baseline values were used to evaluate study outcomes.
RESULTS


Eighty-four percent (n = 32) of participants completed the immediate postintervention and 4-month follow-up assessments. Adolescents in both conditions reported high treatment satisfaction. Adolescents randomized to HealthTRAC demonstrated greater reductions in BMI relative to SBWC and reported greater use of emotion regulation skills. Finally, caregivers of adolescents randomized to HealthTRAC also reported greater improvements in emotion regulation abilities among their adolescents at the 4-month follow-up.
CONCLUSION


Findings suggest that the HealthTRAC intervention was acceptable, feasible to deliver, and demonstrated a positive impact on BMI and emotion regulation abilities. These data suggest that ER is related to health decision-making and is relevant to most overweight/obese adolescents seeking to lose weight.",2020,Adolescents randomized to HealthTRAC demonstrated greater reductions in BMI relative to SBWC and reported greater use of emotion regulation skills.,"['adolescents with overweight and obesity', 'Adolescents with overweight or obesity (N = 38), ages 13 to 17 years', 'Adolescents with Overweight and Obesity Attempting to Lose Weight']","['HealthTRAC', 'HealthTRAC intervention', 'program (HealthTRAC) combining 2 efficacious interventions', 'standardized behavioral weight management intervention [SBWC', 'SBWC or HealthTRAC', 'Adapted Emotion Regulation Intervention']","['emotion regulation skills', 'BMI and emotion regulation abilities', 'adolescent self-reports of intervention acceptability and reported emotion regulation (ER) abilities and caregiver report of adolescent ER skills', 'Body mass index (BMI', 'BMI relative to SBWC', 'emotion regulation abilities']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]",,0.0336946,Adolescents randomized to HealthTRAC demonstrated greater reductions in BMI relative to SBWC and reported greater use of emotion regulation skills.,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hadley', 'Affiliation': 'Department of Counseling Psychology and Human Services, College of Education, University of Oregon, Eugene, OR.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Houck', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barker', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Wickham', 'Affiliation': ""Bradley/Hasbro Children's Research Center/Rhode Island Hospital, Providence, RI.""}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Bogner', 'Affiliation': 'Department of Counseling Psychology and Human Services, College of Education, University of Oregon, Eugene, OR.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000837']
2894,32740306,Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol.,"BACKGROUND


Incorporating a patient's personal narrative into the electronic health record is an opportunity to more fully integrate the patient's values and beliefs into care, thus creating opportunities to deliver high-quality/high-value, person-centered care.
OBJECTIVES


The aim of the study was to present a study protocol of a narrative intervention to (a) compare the effects of the narrative intervention to usual care on primary outcome of person's (patient) perceptions of quality of communication, (b) compare the effects of the narrative intervention on secondary outcomes of biopsychosocial well-being, and (c) examine the feasibility and acceptability of the narrative intervention from the perspective of both persons: the patient and the acute care bedside nurse.
METHODS


A randomized control trial is being conducted with a targeted enrollment of 80 patient participants and 80 nurse participants. The patient participants include individuals who are admitted to the acute care hospital for either heart failure or end-stage renal disease. An acute care beside nurse who has cared for the patient participant is also enrolled. Through a 1:1 random allocation scheme, stratified by illness, we will enroll 40 in the narrative intervention group and 40 in the usual care group. Patient participants will be assessed for patient-reported outcomes of patient's perception of quality of communication and biopsychosocial well-being.
RESULTS


The study began in October 2019; 53 potential patient participants have been approached, 21 have enrolled, and 20 have completed the data collection process.
DISCUSSION


The testing and integration of a person-centered narrative into the electronic health record is a novel approach to provide opportunities for improvement in communication between patients and nurses. The results from this study will provide important preliminary knowledge to inform future randomized clinical trials of narrative interventions leading to advances in how to best provide high-value, high-quality, person-centered care for persons living with serious illness.",2020,The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses.,"['80 patient participants and 80 nurse participants', 'October 2019; 53 potential patient participants have been approached, 21 have enrolled, and 20 have completed the data collection process', 'patient participants include individuals who are admitted to the acute care hospital for either heart failure or end-stage renal disease', 'persons living with serious illness']","['narrative intervention', 'narrative intervention to usual care']","['feasibility and acceptability', ""patient's perception of quality of communication and biopsychosocial well-being""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0644748,The testing and integration of a person-centered narrative into the EHR is a novel approach to provide opportunities for improvement in communication between patients and nurses.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Coats', 'Affiliation': 'Heather Coats, PhD, APRN-BC, is Assistant Professor of Research, College of Nursing, University of Colorado Anschutz Medical Campus, Aurora. Nadia Shive, BA, CCRC, is Professional Research Assistant, College of Nursing, University of Colorado Anschutz Medical Campus, Aurora. Ardith Z. Doorenbos, PhD, RN, FAAN, is Nursing Collegiate Professor, College of Nursing, University of Illinois at Chicago, and Director of Palliative Care and Co-leader of Cancer Prevention and Control Program, University of Illinois Cancer Center, Chicago. Sarah Schmiege, PhD, is Biostatistician, Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Shive', 'Affiliation': ''}, {'ForeName': 'Ardith Z', 'Initials': 'AZ', 'LastName': 'Doorenbos', 'Affiliation': ''}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schmiege', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000463']
2895,32740449,"Factors Associated With the Recurrence, Persistence, and Clearance of Asymptomatic Bacterial Vaginosis Among Young African American Women: A Repeated-Measures Latent Class Analysis.","BACKGROUND


Although risk factors of recurrent and persistent bacterial vaginosis (BV) have been explored in the literature, the longitudinal incidence patterns of BV remain elusive.
METHODS


We conducted a secondary analysis of longitudinal data from a randomized clinical trial of metronidazole treatment for asymptomatic BV. Repeated-measures latent class analysis was used to identify distinct longitudinal patterns of incident BV cases. Multinomial regression analysis was used to determine the predictors of class membership. The multivariable model included age, last BV treatment, douching frequency, birth control, sexual risk behavior, and assignment to treatment arm.
RESULTS


A total of 858 African American women who were asymptomatic for BV were included in the analysis. Three emergent patterns of BV for 12 months were identified by repeated-measures latent class analysis: persistent (55.9%), recurrent (30.5%), and clearance (13.5%). Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted odds ratio [adjOR], 0.55; 95% confidence interval [CI], 0.18-0.63). Women who had sex with women had significantly lower odds of belonging to the persistent class versus the clearance class (adjOR, 0.38; 95% CI, 0.22-0.68) and the recurrent class (adjOR, 0.43; 95% CI, 0.23-0.81). Those who were assigned to the treatment arm had significantly increased odds of being in the recurrent class versus the clearance class (adjOR, 1.92; 95% CI, 1.22-3.03). Women older than 21 years were significantly more likely to be in the recurrent class (adjOR, 1.88; 95% CI, 1.17-3.00) than in the clearance class.
CONCLUSIONS


Assessment of BV cases revealed distinct patterns of recurrence and persistence of BV, which were significantly associated with douching, being in the treatment arm, and being a woman who had sex with women.",2020,Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted Odds Ratio [adjOR]: 0.55; 95% Confidence Interval [CI]: 0.18-0.63).,"['asymptomatic BV', 'Young African American Women', '858 African American women, asymptomatic for BV', 'Women who had sex with women (WSW', 'woman who had sex with women']",['metronidazole'],"['recurrence and persistence of BV', 'Recurrence, Persistence and Clearance of Asymptomatic Bacterial Vaginosis']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533642', 'cui_str': 'Women Who Have Sex With Women'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",858.0,0.0658257,Participants who had douched at least once had significantly lower odds to be in the recurrent class versus the clearance class (adjusted Odds Ratio [adjOR]: 0.55; 95% Confidence Interval [CI]: 0.18-0.63).,"[{'ForeName': 'Makella S', 'Initials': 'MS', 'LastName': 'Coudray', 'Affiliation': 'From the Department of Epidemiology, Robert Stempel College of Public Health and Social Work.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Sheehan', 'Affiliation': 'From the Department of Epidemiology, Robert Stempel College of Public Health and Social Work.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Cook', 'Affiliation': 'Department of Epidemiology, College of Public Health and Health Professions.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Schwebke', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Madhivanan', 'Affiliation': 'Department of Health Promotion Sciences, Mel & Enid Zuckerman College of Public Health.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001256']
2896,32740882,Comparison of the therapeutic effect of Meibomian Thermal Pulsation LipiFlow® on obstructive and hyposecretory meibomian gland dysfunction patients.,"PURPOSE


To explore the effect of Meibomian Thermal Pulsation LipiFlow® on obstructive and hyposecretory meibomian gland dysfunction.
METHODS


Twenty-five subjects diagnosed with obstructive meibomian gland dysfunction (OMGD) and another 25 hyposecretory meibomian gland dysfunction (HMGD) patients were collected receiving the unilateral treatment with LipiFlow®. We evaluated the parameters variables including Standard Patient Evaluation of Eye Dryness (SPEED), Ocular Surface Disease Index (OSDI), Schirmer I test (SIT), noninvasive keratographic breakup time (NIKBUT), tear meniscus height (TMH), and lipid layer thickness (LLT), partial blink rate (PBR), meibomian gland loss, meibomian gland morphology with LipiView®. Meibomian gland expressibility and secretion quality were evaluated for OMGD subjects. All the results were recorded pre-therapy and 4 weeks, 8 weeks, 12 weeks post-therapy.
RESULTS


SPEED, OSDI, and PB decreased, meanwhile, NIKBUT, TMH, SIT, and LLT increased compared with baseline in both groups after treatment (P < 0.001), whereas the magnitude of the improvement in the OMGD group was greater than that in the HMGD group (P < 0.001). There was no significant posttreatment structural meibomian gland change in both groups. The meibomian gland expressibility and secretion quality score increased after treatment in the OMGD group (P < 0.001).
CONCLUSIONS


The Meibomian Thermal Pulsation LipiFlow® is effective for both obstructive and hyposecretory meibomian gland dysfunction and the therapeutic effect on obstructive meibomian gland dysfunction is greater than that on hyposecretory meibomian gland dysfunction.",2020,"The meibomian gland expressibility and secretion quality score increased after treatment in the OMGD group (P < 0.001).
","['obstructive and hyposecretory meibomian gland dysfunction patients', 'Twenty-five subjects diagnosed with obstructive meibomian gland dysfunction (OMGD) and another 25 hyposecretory meibomian gland dysfunction (HMGD) patients were collected receiving the']","['HMGD', 'Meibomian Thermal Pulsation LipiFlow®', 'unilateral treatment with LipiFlow®']","['meibomian gland expressibility and secretion quality score', 'Standard Patient Evaluation of Eye Dryness (SPEED), Ocular Surface Disease Index (OSDI', 'SPEED, OSDI, and PB decreased, meanwhile, NIKBUT, TMH, SIT, and LLT', 'structural meibomian gland change', 'I test (SIT), noninvasive keratographic breakup time (NIKBUT), tear meniscus height (TMH), and lipid layer thickness (LLT), partial blink rate (PBR), meibomian gland loss, meibomian gland morphology with LipiView®', 'Meibomian gland expressibility and secretion quality']","[{'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",25.0,0.0238317,"The meibomian gland expressibility and secretion quality score increased after treatment in the OMGD group (P < 0.001).
","[{'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Hongxue', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology and Chongqing Eye Institute, Chongqing, China. xumeihome@163.com.'}]",International ophthalmology,['10.1007/s10792-020-01533-y']
2897,32746950,Investigating cultural differences in the effects of expressive suppression when processing traumatic distressing material.,"BACKGROUND


While suppression is associated with detrimental post-traumatic psychological adjustment, research has not considered the effect of culture on this relationship.
AIMS


This study investigated cultural differences in the effects of expressive suppression, whilst watching a traumatic film, on subjective distress, psychophysiological responses and intrusive memory.
METHOD


Australians of European heritage or East Asian Australian participants (n = 82) were randomly assigned to either a suppression group (instructed to suppress their emotions during the film) or a control group (no instructions regarding emotion management). Electrodermal activity, heart rate and heart rate variability (root mean square of the successive differences; RMSSD) were measured pre-, during and post-film. Participants reported the number of film-related intrusions in the 5 min and 7 days post-viewing.
RESULTS


While the European Australian group did not differ significantly on RMSSD, the East Asian suppression group scored significantly higher on RMSSD during the film than the East Asian control group. Second, those in the suppression groups, regardless of cultural background, reported significantly fewer intrusions immediately post-film than controls. Third, we found that for the European Australian group, change in heart rate interacted with group (control versus suppression) when predicting weekly intrusions. However, for the East Asian group change in heart rate did not interact with group when predicting weekly intrusions.
CONCLUSIONS


The findings are discussed in the context of current research on culture and emotion regulation and implications for post-traumatic stress disorder.",2020,"While the European Australian group did not differ significantly on RMSSD, the East Asian suppression group scored significantly higher on RMSSD during the film than the East Asian control group.",['Australians of European heritage or East Asian Australian participants (n = 82'],['suppression group (instructed to suppress their emotions during the film) or a control group (no instructions regarding emotion management'],"['Electrodermal activity, heart rate and heart rate variability (root mean square of the successive differences; RMSSD', 'number of film-related intrusions', 'heart rate', 'RMSSD', 'subjective distress, psychophysiological responses and intrusive memory']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424129', 'cui_str': 'Suppressed emotion'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",82.0,0.0302343,"While the European Australian group did not differ significantly on RMSSD, the East Asian suppression group scored significantly higher on RMSSD during the film than the East Asian control group.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Nagulendran', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jobson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000508']
2898,32739080,No Major Functional Benefit After Bicompartmental Knee Arthroplasty Compared to Total Knee Arthroplasty at 5-Year Follow-Up.,"BACKGROUND


In case of isolated medial and patellofemoral joint arthritis, bicompartmental knee arthroplasty (BCA) is an alternative to total knee arthroplasty (TKA). The purpose of our prospective, randomized study is to compare the clinical outcome of BCA vs TKA.
METHODS


Eighty patients with isolated medial and patellofemoral osteoarthritis were randomly assigned to either BCA or TKA. Patients were evaluated preoperatively, 3, 6, and 12 months, and 2 and 5 years after the procedure. Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles activity scores were calculated at each follow-up; Forgotten Joint Score was assessed at final follow-up.
RESULTS


There was an improvement in Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles scores in both groups but no significant differences between both groups at any follow-up. The Forgotten Joint Score at 5-year follow-up was not significantly different either. Range of motion was significantly greater in the BCA group from 1-year follow-up onward.
CONCLUSION


Our study did not show significant differences in clinical scores between BCA and TKA; only range of motion was significantly greater in BCA. Therefore, it is questionable whether this difference justifies the complexity of BCA associated with higher risk of failure. Maybe staged patellofemoral joint arthroplasty in the presence of a well-functioning UKA is an option for BCA and an alternative to revision to TKA. Long-term studies are needed to explore the potential benefits of BCA.",2020,Our study did not show significant differences in clinical scores between BCA and TKA; only range of motion was significantly greater in BCA.,['Eighty patients with isolated medial and patellofemoral osteoarthritis'],"['BCA', 'BCA or TKA', 'bicompartmental knee arthroplasty (BCA']","['Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles activity scores', 'Knee Society Score, Oxford Knee Score, and the University of California,Los Angeles scores', 'Range of motion', 'Forgotten Joint Score']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}]",80.0,0.0372399,Our study did not show significant differences in clinical scores between BCA and TKA; only range of motion was significantly greater in BCA.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schrednitzki', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Beier', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Marx', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Halder', 'Affiliation': 'Department of Orthopaedic Surgery, Kremmen, Germany.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.003']
2899,32739184,Re: Ang et al.: Randomized clinical trial comparing femtosecond LASIK and small-incision lenticule extraction (Ophthalmology. 2020;127:724-730).,,2020,,[],['femtosecond LASIK and small-incision lenticule extraction'],[],[],"[{'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",[],,0.0877184,,"[{'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Wallerstein', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada; LASIK MD, Montreal, Quebec, Canada. Electronic address: awallerstein@lasikmd.com.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Gauvin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, McGill University, Montreal, Quebec, Canada; LASIK MD, Montreal, Quebec, Canada.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.032']
2900,32747417,Prognostic and Predictive Biomarkers in Patients with Metastatic Colorectal Cancer Receiving Regorafenib.,"Regorafenib is a tyrosine kinase inhibitor approved by the FDA for the treatment of patients with chemotherapy refractory metastatic colorectal cancer (mCRC). Regorafenib inhibits signaling through multiple receptors associated with angiogenesis, metastasis, and tumor immunity. Here, we report biomarker results from LCCC1029, a randomized, placebo-controlled, phase II trial of chemotherapy ± regorafenib in patients with second-line mCRC. A panel of 20 soluble protein biomarkers (termed the Angiome) was assessed in the plasma of 149 patients from the LCCC1029 trial both at baseline and along the treatment continuum. Baseline protein levels were analyzed for prognostic and predictive value for progression-free survival (PFS) and overall survival (OS). Changes in protein levels during treatment were analyzed for potential pharmacodynamic effects. Six markers (HGF, IL6, PlGF, VEGF-R1, OPN, and IL6R) were found to be prognostic for PFS. Nine markers (IL6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1) were prognostic for OS. Higher baseline levels of OPN ( P   intx  = 0.0167), VCAM-1 ( P   intx  = 0.0216), and PDGF-AA ( P   intx  = 0.0435) appeared to predict for PFS benefit from regorafenib compared with placebo. VCAM-1 was also potentially predictive of OS benefit from regorafenib compared with placebo ( P   intx  = 0.0124). On-treatment changes of six markers reflected potential on-target effect of regorafenib. Consistent results were observed in an Italian cohort where 105 patients with late-stage mCRC received regorafenib monotherapy. The key findings of this study suggest that VCAM-1 may be a predictive biomarker for regorafenib benefit, while multiple protein markers may be prognostic of outcome in patients with mCRC.",2020,"Nine markers (IL-6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1) were prognostic for OS.","['Metastatic Colorectal Cancer Patients Receiving Regorafenib', 'second-line mCRC patients', '149 patients from the LCCC1029 trial both at baseline and along the treatment continuum', 'chemotherapy-refractory metastatic colorectal cancer (mCRC) patients']","['regorafenib', 'chemotherapy ± regorafenib', 'Regorafenib', 'regorafenib monotherapy', 'placebo']","['progression-free survival (PFS) and overall survival (OS', 'Six markers (HGF, IL-6, PlGF, VEGF-R1, OPN, and IL-6R', 'OPN', 'Baseline protein levels', 'Nine markers (IL-6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1', 'VCAM-1 ', 'protein levels']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0530678', 'cui_str': 'thrombospondin 2'}]",149.0,0.156656,"Nine markers (IL-6, TIMP-1, PlGF, VCAM-1, ICAM-1, OPN, TSP-2, HGF, and VEGF-R1) were prognostic for OS.","[{'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bell Burdett', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Sibley', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Ace J', 'Initials': 'AJ', 'LastName': 'Hatch', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Starr', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Brady', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Hammond', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, Unit of Medical Oncology, Azienda Ospedaliero- Universitaria Pisana, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Dominic T', 'Initials': 'DT', 'LastName': 'Moore', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Hanna K', 'Initials': 'HK', 'LastName': 'Sanoff', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina. anixon@duke.edu.'}]",Molecular cancer therapeutics,['10.1158/1535-7163.MCT-20-0249']
2901,32747522,Effect of fremanezumab on quality of life and productivity in patients with chronic migraine.,"OBJECTIVE


To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).
METHODS


HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.
RESULTS


The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale ( p  < 0.05) and PGIC scores ( p  < 0.0001) as well as significant reductions from baseline in WPAI:GH scores ( p  < 0.01) and presenteeism (impairment while working;  p  < 0.05) vs placebo.
CONCLUSIONS


Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM.
CLINICALTRIALSGOV IDENTIFIER


NCT02621931.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.",2020,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","['patients with chronic migraine (CM', 'Patients With Chronic Migraine', '1121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with', 'patients with CM']","['fremanezumab', 'fremanezumab quarterly (675 mg at baseline, placebo', 'Fremanezumab', 'fremanezumab quarterly or monthly vs placebo', 'placebo']","[""health-related quality of life, health status, patients' global impression of change, and productivity"", 'Quality of Life and Productivity', 'health-related quality of life and productivity', 'migraine-specific quality of life, overall health status', 'EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire', 'Migraine-Specific Quality of Life (MSQoL) questionnaire', 'PGIC scores', 'WPAI:GH scores', 'Patient Global Impression of Change (PGIC) questionnaire', 'EQ-5D-5L visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1121.0,0.33054,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA. Richard.Lipton@einstein.yu.edu.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}]",Neurology,['10.1212/WNL.0000000000010000']
2902,32748071,"A new self-designed ""tongue root holder"" device to aid fiberoptic intubation.","OBJECTIVE


In this study, we aimed to assess the feasibility of fiberoptic intubation (FOI), using a new, self-designed, ""tongue root holder"" device, in combination with the jaw thrust maneuver.
METHODS


Three hundred patients undergoing elective surgery requiring orotracheal intubation were enrolled. Patients presented at least one or more risk factors for difficult airway. The patients were randomly allocated at a 1:1 ratio to one of two groups: group L, FOI with tongue root holder, or group C, standard FOI. Orotracheal FOI was performed after commencement of anesthesia. The jaw thrust maneuver was applied in both groups to facilitate advancement of the fiberoptic bronchoscope. The primary endpoint was the feasibility of FOI. The secondary endpoints were number of attempts, time to intubation, and airway clearance at the soft palate and epiglottis levels.
RESULTS


The FOI was achieved in all 150 patients in group L, significantly higher than that in group C (100% vs 95.3%; P = 0.015). Less attempts of intubation were made in group L (P = 0.039). Mean time to successful intubation on the first attempt was shorter in group L (P < 0.001). The mean times to view the vocal cord and carina were also shorter in group L (P = 0.011 and P < 0.001, respectively). Airway clearance was better in group L at both the soft palate and the glottis levels (P = 0.010 and P = 0.038, respectively).
CONCLUSIONS


This study shows that FOI is feasible with the newly introduced, self-designed, ""tongue root holder"" device, when combined with the jaw thrust maneuver in patients with risk factors for difficult airway. The device also provides better airway clearance, less intubation attempts, and shorter time to intubation at first attempt.
CLINICAL RELEVANCE


Fiberoptic bronchoscope has been the gold standard for routine management of difficult airway. A technique to open the airway is introduced to reduce the incidence rate of upper airway obstruction.",2020,"The mean times to view the vocal cord and carina were also shorter in group L (P = 0.011 and P < 0.001, respectively).","['Three hundred patients undergoing elective surgery requiring orotracheal intubation were enrolled', 'patients with risk factors for difficult airway']","['FOI with tongue root holder, or group C, standard FOI', 'fiberoptic intubation (FOI']","['feasibility of FOI', 'mean times to view the vocal cord and carina', 'incidence rate of upper airway obstruction', 'FOI', 'Airway clearance', 'Orotracheal FOI', 'glottis levels', 'Mean time to successful intubation', 'number of attempts, time to intubation, and airway clearance at the soft palate and epiglottis levels']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0226956', 'cui_str': 'Structure of pharyngeal portion of dorsum of tongue'}, {'cui': 'C1551377', 'cui_str': 'Holder'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0225594', 'cui_str': 'Structure of carina of trachea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0472580', 'cui_str': 'Orotracheal fiberoptic intubation'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030219', 'cui_str': 'Soft palate structure'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}]",300.0,0.0458913,"The mean times to view the vocal cord and carina were also shorter in group L (P = 0.011 and P < 0.001, respectively).","[{'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, People's Republic of China.""}, {'ForeName': 'Junbei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, People's Republic of China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, People's Republic of China.""}, {'ForeName': 'Zhengnian', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, People's Republic of China. dingzhengnian@yeah.net.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Qi', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital with Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, People's Republic of China. taoqinjmu@hotmail.com.""}]",Clinical oral investigations,['10.1007/s00784-020-03297-2']
2903,32749999,Comparing Web-Based and Lab-Based Cognitive Assessment Using the Cambridge Neuropsychological Test Automated Battery: A Within-Subjects Counterbalanced Study.,"BACKGROUND


Computerized assessments are already used to derive accurate and reliable measures of cognitive function. Web-based cognitive assessment could improve the accessibility and flexibility of research and clinical assessment, widen participation, and promote research recruitment while simultaneously reducing costs. However, differences in context may influence task performance.
OBJECTIVE


This study aims to determine the comparability of an unsupervised, web-based administration of the Cambridge Neuropsychological Test Automated Battery (CANTAB) against a typical in-person lab-based assessment, using a within-subjects counterbalanced design. The study aims to test (1) reliability, quantifying the relationship between measurements across settings using correlational approaches; (2) equivalence, the extent to which test results in different settings produce similar overall results; and (3) agreement, by quantifying acceptable limits to bias and differences between measurement environments.
METHODS


A total of 51 healthy adults (32 women and 19 men; mean age 36.8, SD 15.6 years) completed 2 testing sessions, which were completed on average 1 week apart (SD 4.5 days). Assessments included equivalent tests of emotion recognition (emotion recognition task [ERT]), visual recognition (pattern recognition memory [PRM]), episodic memory (paired associate learning [PAL]), working memory and spatial planning (spatial working memory [SWM] and one touch stockings of Cambridge), and sustained attention (rapid visual information processing [RVP]). Participants were randomly allocated to one of the two groups, either assessed in-person in the laboratory first (n=33) or with unsupervised web-based assessments on their personal computing systems first (n=18). Performance indices (errors, correct trials, and response sensitivity) and median reaction times were extracted. Intraclass and bivariate correlations examined intersetting reliability, linear mixed models and Bayesian paired sample t tests tested for equivalence, and Bland-Altman plots examined agreement.
RESULTS


Intraclass correlation (ICC) coefficients ranged from ρ=0.23-0.67, with high correlations in 3 performance indices (from PAL, SWM, and RVP tasks; ρ≥0.60). High ICC values were also seen for reaction time measures from 2 tasks (PRM and ERT tasks; ρ≥0.60). However, reaction times were slower during web-based assessments, which undermined both equivalence and agreement for reaction time measures. Performance indices did not differ between assessment settings and generally showed satisfactory agreement.
CONCLUSIONS


Our findings support the comparability of CANTAB performance indices (errors, correct trials, and response sensitivity) in unsupervised, web-based assessments with in-person and laboratory tests. Reaction times are not as easily translatable from in-person to web-based testing, likely due to variations in computer hardware. The results underline the importance of examining more than one index to ascertain comparability, as high correlations can present in the context of systematic differences, which are a product of differences between measurement environments. Further work is now needed to examine web-based assessments in clinical populations and in larger samples to improve sensitivity for detecting subtler differences between test settings.",2020,"However, reaction times were slower during web-based assessments, which undermined both equivalence and agreement for reaction time measures.","['51 healthy adults (32 women and 19 men; mean age 36.8, SD 15.6 years']","['Web-Based and Lab-Based Cognitive Assessment Using the Cambridge Neuropsychological Test Automated Battery', 'Cambridge Neuropsychological Test Automated Battery (CANTAB', 'assessed in-person in the laboratory first (n=33) or with unsupervised web-based assessments on their personal computing systems first']","['equivalent tests of emotion recognition (emotion recognition task [ERT]), visual recognition (pattern recognition memory [PRM]), episodic memory (paired associate learning [PAL]), working memory and spatial planning (spatial working memory [SWM] and one touch stockings of Cambridge), and sustained attention (rapid visual information processing [RVP', 'reaction times', 'Performance indices (errors, correct trials, and response sensitivity) and median reaction times', 'Performance indices']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205435', 'cui_str': 'First'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0445269', 'cui_str': 'Socks'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",51.0,0.109663,"However, reaction times were slower during web-based assessments, which undermined both equivalence and agreement for reaction time measures.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Backx', 'Affiliation': 'Cambridge Cognition Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Skirrow', 'Affiliation': 'Cambridge Cognition Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Dente', 'Affiliation': 'Cambridge Cognition Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Barnett', 'Affiliation': 'Cambridge Cognition Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Francesca K', 'Initials': 'FK', 'LastName': 'Cormack', 'Affiliation': 'Cambridge Cognition Ltd, Cambridge, United Kingdom.'}]",Journal of medical Internet research,['10.2196/16792']
2904,32756067,Feasibility of a Cognitive Training Game in Parkinson's Disease: The Randomized Parkin'Play Study.,"Cognitive training (CT) shows modest positive effects on cognitive function in patients with Parkinson's disease (PD). Gamification may enhance adherence to traditional CT, but this has not been studied yet. Here, we investigated the feasibility of a gamified CT. We performed a randomized controlled trial including PD patients with mild cognitive impairment. Participants were randomly allocated to a 12-week home-based gamified CT intervention or waiting-list control group. Assessments were performed at baseline and at weeks 12 and 24. Forty-one patients were included (21 intervention and 20 waiting-list controls). Sixty-three percent of the intervention group trained >50% of the recommended sessions, while 81% voluntarily continued training after 12 weeks. After 24 weeks, 87.5% graded the game to be satisfactory. Global cognition scores improved after 24 weeks. Home-based gamified CT shows acceptable feasibility in patients with PD, and we observed preliminary indications for efficacy. Larger trials are needed to establish this efficacy.",2020,Global cognition scores improved after 24 weeks.,"[""patients with Parkinson's disease (PD"", ""Parkinson's Disease"", 'PD patients with mild cognitive impairment', 'patients with PD', 'Forty-one patients were included (21 intervention and 20 waiting-list controls']","['gamified CT', 'Cognitive Training Game', '12-week home-based gamified CT intervention or waiting-list control group', 'Cognitive training (CT']","['cognitive function', 'Global cognition scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",41.0,0.0472378,Global cognition scores improved after 24 weeks.,"[{'ForeName': 'Sjors C F', 'Initials': 'SCF', 'LastName': 'van de Weijer', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands, sjors.vande.weijer@mumc.nl.'}, {'ForeName': 'Annelien A', 'Initials': 'AA', 'LastName': 'Duits', 'Affiliation': 'Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Köhler', 'Affiliation': 'School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Tissingh', 'Affiliation': 'Department of Neurology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Kuijf', 'Affiliation': 'Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",European neurology,['10.1159/000509685']
2905,32752026,Improving Breastfeeding by Empowering Mothers in Vietnam: A Randomised Controlled Trial of a Mobile App.,"Breastfeeding provides benefits to the infant and mother; however, the rates of breastfeeding, particularly exclusive breastfeeding, remain below optimal levels in many Asian countries. The aim of this study is to review the benefits of breastfeeding to mothers and infants and current rates of breastfeeding in Vietnam, and to evaluate the effectiveness of a mobile application on exclusive breastfeeding among mothers in Vietnam. A two-arm, parallel triple-blinded randomised controlled trial will be conducted among 1000 mothers in Hanoi City, Vietnam, during 2020-2021. Eligible participants are pregnant women who will seek antenatal care from health facilities at 24-36 weeks of gestation and plan to deliver at two participating hospitals, own a smartphone, and carry a singleton foetus. Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group. A smartphone app will be developed to deliver breastfeeding and non-breastfeeding information to the intervention and control group, respectively. Data will be collected at baseline, before hospital discharge, and at 1, 4, and 6 months postpartum. This study envisages demonstrating whether a smartphone-based intervention can be effective at improving breastfeeding in Vietnam. Trials registration: ACTRN12619000531112.",2020,"Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group.","['1000 mothers in Hanoi City, Vietnam, during 2020-2021', 'Eligible participants are pregnant women who will seek antenatal care from health facilities at 24-36 weeks of gestation and plan to deliver at two participating hospitals, own a smartphone, and carry a singleton foetus', 'Empowering Mothers in Vietnam', 'mothers in Vietnam']",['smartphone-based intervention'],[],"[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.142532,"Permuted-block randomisation method stratified by maternal age, education and parity will be used to ensure an equal number of participants in each group.","[{'ForeName': 'Thi Thuy Duong', 'Initials': 'TTD', 'LastName': 'Doan', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Binns', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Ngoc Minh', 'Initials': 'NM', 'LastName': 'Pham', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health, Curtin University, Bentley, WA 6102, Australia.'}, {'ForeName': 'Thi Phuong Hoa', 'Initials': 'TPH', 'LastName': 'Dinh', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Thi Thu Ha', 'Initials': 'TTH', 'LastName': 'Bui', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Trung Chuyen', 'Initials': 'TC', 'LastName': 'Tran', 'Affiliation': 'Faculty of Information Technology, Department of Hanoi University of Mining and Geology, 18 Vien Street-Bac Tu Liem District, Hanoi 10000, Vietnam.'}, {'ForeName': 'Xuan Hoai', 'Initials': 'XH', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of IT, Ho Chi Minh University of Technology (HUTECH), Ho Chi Minh 700000, Vietnam.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Giglia', 'Affiliation': 'Foodbank Perth Airport, Perth, WA 6105, Australia.'}, {'ForeName': 'Fenglian', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Data Analysis & Surgical Outcomes Unit (DASO), Royal North Shore Hospital, St Leonards, NSW 2065, Australia.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Faculty of Social Sciences, Behavior and Health Education, Hanoi University of Public Health, 1A Duc Thang Street, Bac Tu Liem District, Hanoi 10000, Vietnam.'}]",International journal of environmental research and public health,['10.3390/ijerph17155552']
2906,32752077,Parental Opinion about the Low FODMAP Diet in Dietary Treatment of Children with Functional Abdominal Pain.,"The aim of this study was primarily to evaluate differences between parental opinion about the diet and overall changes in children's symptoms of functional abdominal pain (FAP) during the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet and National Institute for Health and Care Excellence (NICE) diet. Secondly, this paper examined the agreement between parental perception of children's symptoms and children's self-assessment of symptoms during the diet in both treatment groups. Twenty-seven children with diagnosed functional abdominal pain (FAP) were randomized to one of two group, receiving the low FODMAP diet or the diet based on NICE guidelines. Children reported gastrointestinal symptoms at baseline and during the diet. At the end of the intervention, parents assessed their children's diet and symptoms changes, using Likert scales. The agreement between parental and children assessments of gastrointestinal symptoms was defined as the percentage of compatible answers. In the low FODMAP group a significantly lower percentage of parents (38%) declared that it was easy to follow the diet, compared to the NICE group (57%), ( p  = 0.017). A high percentage of parents in both groups reported improvement in all symptoms of children during dietary intervention. A high level of agreement was also observed between parental and children's self-assessment of abdominal pain intensity and frequency. Our research suggests that in parental opinion the low FODMAP diet is as effective as the diet based on NICE guidelines in children with FAP. However, the low FODMAP diet may seem more difficult to follow, and this may have had an impact on the effectiveness and acceptability of the FODMAP diet by children.",2020,A high level of agreement was also observed between parental and children's self-assessment of abdominal pain intensity and frequency.,"['children with FAP', 'Children with Functional Abdominal Pain', 'Twenty-seven children with diagnosed functional abdominal pain (FAP']","['low FODMAP diet or the diet based on NICE guidelines', 'Low FODMAP Diet']","['functional abdominal pain (FAP', 'gastrointestinal symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",27.0,0.0139782,A high level of agreement was also observed between parental and children's self-assessment of abdominal pain intensity and frequency.,"[{'ForeName': 'Katarzyna Mirosława', 'Initials': 'KM', 'LastName': 'Boradyn', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Sciences, University of Warmia and Mazury in Olsztyn, Słoneczna 45F, 10-718 Olsztyn, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jarocka-Cyrta', 'Affiliation': 'Department of Pediatrics, Gastroenterology and Nutrition, Faculty of Medicine Collegium Medicum, University of Warmia and Mazury in Olsztyn, Żołnierska 18A, 10-561 Olsztyn, Poland.'}, {'ForeName': 'Katarzyna Eufemia', 'Initials': 'KE', 'LastName': 'Przybyłowicz', 'Affiliation': 'Department of Human Nutrition, Faculty of Food Sciences, University of Warmia and Mazury in Olsztyn, Słoneczna 45F, 10-718 Olsztyn, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Obara-Gołębiowska', 'Affiliation': 'Department of Clinical, Developmental and Educational Psychology, Faculty of Social Sciences, University of Warmia and Mazury in Olsztyn, Prawocheńskiego 13, 10-447 Olsztyn, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17155554']
2907,32757065,Effect of carbohydrate-protein supplementation on endurance training adaptations.,"PURPOSE


To examine the influence of post-exercise protein feeding upon the adaptive response to endurance exercise training.
METHODS


In a randomised parallel group design, 25 healthy men and women completed 6 weeks of endurance exercise training by running on a treadmill for 30-60 min at 70-75% maximal oxygen uptake (VO 2max ) 4 times/week. Participants ingested 1.6 g per kilogram of body mass (g kg BM -1 ) of carbohydrate (CHO) or an isocaloric carbohydrate-protein solution (CHO-P; 0.8 g carbohydrate kg BM -1  + 0.8 g protein kg BM -1 ) immediately and 1 h post-exercise. Expired gas, blood and muscle biopsy samples were taken at baseline and follow-up.
RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 L min -1  and 3.0 ± 2 mL kg -1  min -1 , respectively). No change occurred in plasma albumin concentration from baseline to follow-up with CHO-P (4.18 ± 0.18 to 4.23 ± 0.17 g dL -1 ) or CHO (4.17 ± 0.17 to 4.12 ± 0.22 g dL -1 ; interaction: p > 0.05). Mechanistic target of rapamycin (mTOR) gene expression was up-regulated in CHO-P (+ 46%; p = 0.025) relative to CHO (+ 4%) following exercise training.
CONCLUSION


Post-exercise protein supplementation up-regulated the expression of mTOR in skeletal muscle over 6 weeks of endurance exercise training. However, the magnitude of improvement in VO 2max  was similar between groups.",2020,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ",['25 healthy men and women completed 6\xa0weeks of'],"['endurance exercise training by running on a treadmill for 30-60\xa0min at 70-75% maximal oxygen uptake', 'endurance exercise training', 'carbohydrate (CHO', 'carbohydrate-protein supplementation', 'isocaloric carbohydrate-protein solution (CHO-P; 0.8\xa0g carbohydrate kg', 'L']","['BM -1', 'plasma albumin concentration', 'VO 2max', 'Mechanistic target of rapamycin (mTOR) gene expression', 'endurance training adaptations', 'Expired gas, blood and muscle biopsy samples']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",25.0,0.046735,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ","[{'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Alghannam', 'Affiliation': 'Lifestyle and Health Research Center, Health Sciences Research Center, Princess Nourah Bint Abdulrahman University, Riyadh, 84428, Saudi Arabia. AFAlghannam@pnu.edu.sa.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Jedrzejewski', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lemon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, SW15 4JD, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bilzon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04450-1']
2908,32756916,Clinical Application of High-Sensitivity Troponin Testing in the Atherosclerotic Cardiovascular Disease Framework of the Current Cholesterol Guidelines.,"Importance


The 2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol management guidelines identified 2 distinct groups of patients with atherosclerotic cardiovascular disease (ASCVD) prompting different treatment recommendations.
Objective


To investigate whether the addition of high-sensitivity troponin (hsTn) testing to guideline-derived ASCVD risk can improve risk classification and downstream treatment recommendations.
Design, Setting, and Participants


A prospective cohort biomarker substudy was performed that included 8635 patients enrolled in the Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Patients were assigned to risk groups of either very high-risk ASCVD or lower-risk ASCVD based on their cardiovascular history and comorbidities, in line with the 2018 AHA/ACC cholesterol management guidelines criteria. Patients were also classified on the basis of hsTnI level (ARCHITECT assay; Abbott) using cut points of 2 ng/L (limit of detection) and 6 ng/L (risk threshold), followed by joint classification on the basis of clinical features and hsTnI level. The setting was a nested prospective cohort study in a completed multinational trial. Participants were all patients who had a myocardial infarction 1 to 3 years before enrollment, were at least 50 years of age, and had at least 1 high-risk feature. The study dates were October 2010 to December 2014. The dates of analysis were June 2019 to January 2020.
Main Outcomes and Measures


The primary end point was a composite of cardiovascular death, myocardial infarction, or stroke.
Results


Among 8635 patients enrolled in the PEGASUS-TIMI 54 trial, the median age was 65 years (interquartile range, 58-71 years), and 6614 (76.6%) were men; 8340 (96.6%) were White individuals and 176 (2.0%) were Black individuals. Patients meeting clinical criteria for the very high-risk ASCVD group had a primary end point 3-year event rate of 8.8% compared with 5.0% in the lower-risk ASCVD group (hazard ratio, 2.01; 95% CI, 1.58-2.57; P < .001). When patients in the very high-risk ASCVD group were further risk stratified by hsTnI level, 614 of 6789 patients (9.0%) with an undetectable hsTnI level had a 3-year event rate of 2.7% (<1% per year), which was less than the overall rate in the lower-risk ASCVD group. Analogously, in the lower-risk ASCVD group, 417 of 1846 patients (22.6%) with an hsTnI level exceeding 6 ng/L had an event rate of 9.1%, comparable to the overall rate in the very high-risk ASCVD group. The addition of hsTnI to guideline-derived ASCVD risk led to a net reclassification index at event rate of 0.15 (95% CI, 0.10-0.21). Overall, use of hsTnI reclassified 1031 of 8635 patients (11.9%) (1 in 11 with very high-risk ASCVD and 1 in 4 with lower-risk ASCVD).
Conclusions and Relevance


The findings of this cohort substudy suggest that a strategy incorporating hsTn into a guideline-derived ASCVD risk algorithm provides enhanced risk stratification and reclassifies 11.9% of patients into a more appropriate risk group. This application of hsTn testing might be used to optimize the care of patients with ASCVD.",2020,"Overall, use of hsTnI reclassified 1031 of 8635 patients (11.9%) (1 in 11 with very high-risk ASCVD and 1 in 4 with lower-risk ASCVD).
","['2018 American Heart Association/American College of Cardiology (AHA/ACC) cholesterol management guidelines identified 2 distinct groups of patients with atherosclerotic cardiovascular disease (ASCVD', '8635 patients enrolled in the PEGASUS-TIMI 54 trial, the median age was 65 years (interquartile range, 58-71 years), and 6614 (76.6%) were men; 8340 (96.6%) were White individuals and 176 (2.0%) were Black individuals', '8635 patients enrolled in the Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using', 'Participants were all patients who had a myocardial infarction 1 to 3 years before enrollment, were at least 50 years of age, and had at least 1 high-risk feature', 'patients with ASCVD', 'Patients were assigned to risk groups of either very high-risk ASCVD or lower-risk ASCVD based on their cardiovascular history and comorbidities, in line with the 2018 AHA/ACC cholesterol management guidelines criteria']","['Ticagrelor', 'High-Sensitivity Troponin', 'Placebo', 'Aspirin-Thrombolysis']","['3-year event rate', 'overall rate', 'composite of cardiovascular death, myocardial infarction, or stroke']","[{'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",8635.0,0.0553127,"Overall, use of hsTnI reclassified 1031 of 8635 patients (11.9%) (1 in 11 with very high-risk ASCVD and 1 in 4 with lower-risk ASCVD).
","[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Marston', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'Colorado Prevention Center (CPC) Clinical Research, Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Division of Cardiology, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Newark Beth Israel Medical Center, Rutgers New Jersey Medical School, Newark.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Division of Cardiology, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.2981']
2909,32755254,Degree of Blood Pressure Control and Incident Diabetes Mellitus in Chinese Adults With Hypertension.,"Background The association between blood pressure (BP) control and incident diabetes mellitus remains unknown. We aim to investigate the association between degree of time-averaged on-treatment systolic blood pressure (SBP) control and incident diabetes mellitus in hypertensive adults. Methods and Results A total of 14 978 adults with hypertension without diabetes mellitus at baseline were included from the CSPPT (China Stroke Primary Prevention Trial). Participants were randomized double-masked to daily enalapril 10 mg and folic acid 0.8 mg or enalapril 10 mg alone. BP measurements were taken every 3 months after randomization. The primary outcome was incident diabetes mellitus, defined as physician-diagnosed diabetes mellitus, or use of glucose-lowering drugs during follow-up, or fasting glucose ≥126 mg/dL at the exit visit. Over a median of 4.5 years, a significantly higher risk of incident diabetes mellitus was found in participants with time-averaged on-treatment SBP 130 to <140 mm Hg (10.3% versus 7.4%; odds ratio [OR], 1.37; 95% CI, 1.15‒1.64), compared with those with SBP 120 to <130 mm Hg. Moreover, the risk of incident diabetes mellitus increased by 24% (OR, 1.24; 95% CI, 1.00‒1.53) and the incidence of regression to normal fasting glucose (<100 mg/dL) decreased by 29% (OR, 0.71; 95% CI, 0.57‒0.89) in participants with intermediate BP control (SBP/diastolic blood pressure, 130 to <140 and/or 80 to <90 mm Hg), compared with those with a tight BP control of <130/<80 mm Hg. Similar results were found when the time-averaged BP were calculated using the BP measurements during the first 6- or 24-month treatment period, or in the analysis using propensity scores. Conclusions In this non-diabetic, hypertensive population, SBP control in the range of 120 to <130 mm Hg, compared with the 130 to <140 mm Hg, was associated with a lower risk of incident diabetes mellitus.",2020,"Hg (10.3% versus 7.4%; odds ratio [OR], 1.37; 95% CI, 1.15‒1.64), compared with those with SBP 120 to <130 mm Hg.","['hypertensive adults', 'Chinese Adults With Hypertension', 'A total of 14\xa0978 adults with hypertension without diabetes mellitus at baseline were included from the CSPPT (China Stroke Primary Prevention Trial']","['time-averaged on-treatment systolic blood pressure (SBP) control', 'enalapril 10\xa0mg and folic acid 0.8\xa0mg or enalapril 10\xa0mg alone']","['BP measurements', 'incidence of regression to normal fasting glucose', 'incident diabetes mellitus, defined as physician-diagnosed diabetes mellitus, or use of glucose-lowering drugs during follow-up, or fasting glucose ≥126', 'Degree of Blood Pressure Control and Incident Diabetes Mellitus', 'blood pressure (BP) control and incident diabetes mellitus', 'risk of incident diabetes mellitus', 'time-averaged BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0986173', 'cui_str': 'Folic Acid 0.8 MG'}]","[{'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4301973', 'cui_str': 'Average blood pressure'}]",14978.0,0.11366,"Hg (10.3% versus 7.4%; odds ratio [OR], 1.37; 95% CI, 1.15‒1.64), compared with those with SBP 120 to <130 mm Hg.","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology Peking University First Hospital Beijing China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology Peking University First Hospital Beijing China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Guobao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shenzhen Evergreen Medical Institute Shenzhen China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine Anhui Medical University Hefei China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy Peking University First Hospital Beijing China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health Johns Hopkins University Bloomberg School of Public Health Baltimore MD.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology Peking University First Hospital Beijing China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017015']
2910,32757822,Effect of Acupressure on Dynamic Balance in Elderly Women: A Randomized Controlled Trial.,"BACKGROUND


Balance disorders are common in the elderly and are a major cause of falls. This study aimed to determine the effect of acupressure on dynamic balance in elderly women.
METHODS


This randomized controlled clinical trial was conducted on 72 elderly women in Qazvin, Iran. The intervention group received rotary massage using the thumb at the pressure points for 4 weeks, 3 times a week for 20 minutes each session. Dynamic balance in both groups was measured before, 2 and 4 weeks after the intervention using timed up and go test and the step test. Data were analyzed using two way repeated measures ANOVA.
RESULTS


The mean age of participants was 67.34 ± 6.30 with a range of 60 to 80 years old. The results showed statistically significant improvement in the dynamic balance quantified by timed up and go test (%Δ = 26.53) and step test for the right (%Δ = 35.22) and left (Δ% = 32.62) legs ( p  < .001). However, in the control group, no significant change was observed in the dynamic balance after completion of the program.
CONCLUSION


The results support that acupressure therapy can be an effective, safe, and inexpensive method to improve the dynamic balance and maintain maximum autonomy of the elderly.",2020,The results showed statistically significant improvement in the dynamic balance quantified by timed up and go test (%Δ = 26.53) and step test for the right (%Δ = 35.22) and left (Δ% = 32.62) legs ( p  < .001).,"['The mean age of participants was 67.34\xa0±\xa06.30 with a range of 60 to 80\xa0years old', 'Elderly Women', '72 elderly women in Qazvin, Iran', 'elderly women']","['Acupressure', 'rotary massage', 'acupressure', 'acupressure therapy']","['Dynamic balance', 'Dynamic Balance', 'dynamic balance']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",72.0,0.0333272,The results showed statistically significant improvement in the dynamic balance quantified by timed up and go test (%Δ = 26.53) and step test for the right (%Δ = 35.22) and left (Δ% = 32.62) legs ( p  < .001).,"[{'ForeName': 'Seyedeh Ameneh', 'Initials': 'SA', 'LastName': 'Motalebi', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Zajkani', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Social Determinants of Health Research Center (SDH), Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Habibi', 'Affiliation': 'Irannian Scientific Accupancture , Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mafi', 'Affiliation': 'School of Nursing and Midwifery, Qazvin University of Medical Sciences , Qazvin, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ranjkesh', 'Affiliation': 'Children Growth Research Center, Research Institute for Prevention of Non Communicable Diseases, Qazvin University of Medical Sciences , Qazvin, Iran.'}]",Experimental aging research,['10.1080/0361073X.2020.1802981']
2911,32756944,Analysis of the Effects of Isotretinoin on Rhinoplasty Patients.,"BACKGROUND


Although the number of cosmetic surgeries performed per year continues to increase, many candidates have skin problems. Thick-skinned rhinoplasty patients pose a real challenge for surgeons. Fear of performing surgery in patients with a history of isotretinoin use is another concern.
OBJECTIVES


The aim of this study was to study the effects of perioperative isotretinoin on rhinoplasty patient outcomes.
METHODS


This research was conducted on 350 rhinoplasty patients, divided into control and experimental groups, between 2012 and 2015. The experimental group patients were requested to consume isotretinoin from 2 weeks before surgery to 2 months following the surgery. A comparison was made between the 2 groups 1, 3, 6, and 12 months after the surgery.
RESULTS


Statistical tests indicated that the satisfaction of experimental group patients at months 1 and 3 following the surgery was significantly higher than that of control group patients (P < 0.01). Examination of the patients' noses found little evidence for soft tissue repair disturbance and cartilaginous deformities. Nine patients from the experimental group needed revision surgery during the study period, but none of the revision surgeries was for a cause clearly attributable to the intake of isotretinoin.
CONCLUSIONS


The results of this research suggest that isotretinoin causes no evident disturbance to the recovery of rhinoplastic incisions and internal nose structures. Moreover, none of the experimental group patients showed hypertrophic tissues and cartilaginous deformities, and the repair was satisfactory, similar to the control group. However, patients receiving isotretinoin were more satisfied with their operation outcomes and experienced fewer skin problems.
LEVEL OF EVIDENCE: 3


",2020,"RESULTS


Statistical tests indicated that satisfaction of patients of the experimental group in the first and third months following the surgery was significantly higher than the control group (p<0.01).","['patients with history of isotretinoin', 'Rhinoplasty Patients', '303 rhinoplasty patients in the control and experimental groups from 2012 to 2015']",[],"['hypertrophic tissues and cartilaginous deformities', 'revision surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022265', 'cui_str': 'Isotretinoin'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",303.0,0.0267328,"RESULTS


Statistical tests indicated that satisfaction of patients of the experimental group in the first and third months following the surgery was significantly higher than the control group (p<0.01).","[{'ForeName': 'Shahriyar', 'Initials': 'S', 'LastName': 'Yahyavi', 'Affiliation': ''}, {'ForeName': 'Hesam', 'Initials': 'H', 'LastName': 'Jahandideh', 'Affiliation': 'ENT and Head and Neck Research Center and Department, Firoozgar Hospital, The Five Senses Health Institute, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Izadi', 'Affiliation': ''}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Paknejad', 'Affiliation': ''}, {'ForeName': 'Niousha', 'Initials': 'N', 'LastName': 'Kordbache', 'Affiliation': ''}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Taherzade', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjaa219']
2912,32757940,Feasibility and Acceptability of Heart Rate Variability Biofeedback in a Group of Veterans with Fibromyalgia.,"Objectives:  To determine the feasibility and acceptability of a heart rate variability biofeedback (HRVB) protocol in a focus group of Veterans with fibromyalgia (FM).  Design:  A multimethod feasibility and acceptability study.  Settings/location:  A Veterans Health outpatient pain medicine clinic in the southern United States.  Subjects:  The researcher enrolled seven women and three men between the ages of 33 and 68 years with a diagnosis of FM.  Interventions:  Participants practiced HRVB on the  emWave2  at home for 20 min twice daily for 7 weeks.  Outcome measures:  Feasibility to adhere to the HRVB protocol was measured using the practice frequency and time (minutes) data collected from the  emWave2 . The author compared the individual reports from participants with the Credibility/Expectancy Questionnaire to measure the acceptability of the intervention. In addition, the principal investigator evaluated data from the Short-form McGill Pain Questionnaire (SFMQ) and the Revised Fibromyalgia Impact Questionnaire (FIQR) at the baseline and weekly study visits for a signal of efficacy for pain control, functional status, and quality of life (QOL).  Results:  The majority of participants (80%) expected 50% or more improvement in their pain, and (70%) felt HRVB would reduce their FM-related pain by 50%-80%. The mean daily practice frequency rate was 0.80. The mean practice duration was 19.36 min. Pain score differences from the SFMQ were insignificant preintervention and postintervention. The mean total FIQR scores postintervention improved by 18.1 points.  Conclusions:  Findings suggest twice-daily HRVB practice protocol is not feasible. However, 20-min HRVB sessions were feasible and acceptable. Improved FIQR scores post-treatment suggest HRVB may be an effective strategy to improve functional status and QOL for Veterans with FM. ClinicalTrials.gov ID: Pro00079144.",2020,Improved FIQR scores post-treatment suggest HRVB may be an effective strategy to improve functional status and QOL for Veterans with FM.,"['Veterans Health outpatient pain medicine clinic in the southern United States', 'researcher enrolled seven women and three men between the ages of 33 and 68 years with a diagnosis of FM', 'Subjects', 'Veterans with fibromyalgia (FM', 'Veterans with Fibromyalgia']","['heart rate variability biofeedback (HRVB) protocol', 'Heart Rate Variability Biofeedback']","['mean total FIQR scores postintervention', 'FIQR scores', 'mean daily practice frequency rate', 'McGill Pain Questionnaire (SFMQ) and the Revised Fibromyalgia Impact Questionnaire (FIQR', 'mean practice duration', 'Pain score differences', 'FM-related pain', 'functional status and QOL', 'Outcome measures:  Feasibility to adhere to the HRVB protocol', 'practice frequency and time (minutes) data collected from the  emWave2 ', 'pain control, functional status, and quality of life (QOL']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",7.0,0.0664034,Improved FIQR scores post-treatment suggest HRVB may be an effective strategy to improve functional status and QOL for Veterans with FM.,"[{'ForeName': 'Marcelaine', 'Initials': 'M', 'LastName': 'Reneau', 'Affiliation': 'Integrative Pain Clinic, Ralph H. Johnson VA Medical Center, Charleston, SC, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0071']
2913,32761844,Effects of resistance exercise on treatment outcome and laboratory parameters of Takayasu arteritis with magnetic resonance imaging diagnosis: A randomized parallel controlled clinical trial.,"BACKGROUND


Elevated tumor necrosis factor-α (TNF-α) is correlated with refractory Takayasu arteritis (TA), and resistance exercise have been shown to inhibit TNF-α.
HYPOTHESIS


We aimed to explore the effect of resistance exercise in the clinical management of TA.
METHODS


This clinical trial enrolled a total of 342 acute TA patients, who were subsequently randomized to undergo either resistance exercise or relaxation control twice per week for 12 weeks. The disease activity was defined using the primary outcome of Birmingham Vascular Activity Score (BVAS). Secondary outcomes included levels of plasma TNF-α and C-reactive protein (CRP), and the erythrocyte sedimentation rate (ESR).
RESULTS


BVAS scores along with other laboratory parameters obtained from the patients in the resistance exercise group showed a gradual decline throughout the course of the trial. By contrast, outcomes appeared largely unaltered in the relaxation control group patients. Analyses also revealed that plasma TNF-α displayed strong linear correlations with ESR, BVAS scores, and plasma CRP levels.
CONCLUSION


Resistance exercise could substantially improve treatment outcomes as well as laboratory parameters in patients with acute TA, probably through decreasing TNF-α.",2020,"Secondary outcomes included levels of plasma TNF-α and C-reactive protein (CRP), and the erythrocyte sedimentation rate (ESR).
","['patients with acute TA, probably through decreasing TNF-α', '342 acute TA patients']","['resistance exercise or relaxation control', 'magnetic resonance imaging diagnosis', 'Resistance exercise', 'resistance exercise']","['ESR, BVAS scores, and plasma CRP levels', 'disease activity', 'levels of plasma TNF-α and C-reactive protein (CRP), and the erythrocyte sedimentation rate (ESR', 'Birmingham Vascular Activity Score (BVAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039263', 'cui_str': ""Takayasu's disease""}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C5191280', 'cui_str': '342'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428493', 'cui_str': 'Plasma C-reactive protein measurement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",342.0,0.160481,"Secondary outcomes included levels of plasma TNF-α and C-reactive protein (CRP), and the erythrocyte sedimentation rate (ESR).
","[{'ForeName': 'Guoce', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of MRI, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Fenghai', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of MRI, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of MRI, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Yancheng', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of MRI, Cangzhou Central Hospital, Cangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of MRI, Cangzhou Central Hospital, Cangzhou, China.'}]",Clinical cardiology,['10.1002/clc.23439']
2914,32763240,"A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, for Active Mild to Moderate Ulcerative Colitis.","BACKGROUND & AIMS


Firmicutes bacteria produce metabolites that maintain the intestinal barrier and mucosal immunity. Firmicutes are reduced in the intestinal microbiota of patients with ulcerative colitis (UC). In a phase 1b trial of patients with UC, we evaluated the safety and efficacy of SER-287, an oral formulation of Firmicutes spores, and the effects of vancomycin preconditioning on expansion (engraftment) of SER-287 species in the colon.
METHODS


We conducted a double-blind trial of SER-287 in 58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1). Participants received 6 days of preconditioning with oral vancomycin (125 mg, 4 times daily) or placebo followed by 8 weeks of oral SER-287 or placebo. Patients were randomly assigned (2:3:3:3) to groups that received placebo followed by either placebo or SER-287 once weekly, or vancomycin followed by SER-287 once weekly, or SER-287 once daily. Clinical end points included safety and clinical remission (modified Mayo score ≤2; endoscopic subscores 0 or 1). Microbiome end points included SER-287 engraftment (dose species detected in stool after but not before SER-287 administration). Engraftment of SER-287 and changes in microbiome composition and associated metabolites were measured by analyses of stool specimens collected at baseline, after preconditioning, and during and 4 weeks after administration of SER-287 or placebo.
RESULTS


Proportions of patients with adverse events did not differ significantly among groups. A higher proportion of patients in the vancomycin/SER-287 daily group (40%) achieved clinical remission at week 8 than patients in the placebo/placebo group (0%), placebo/SER-287 weekly group (13.3%), or vancomycin/SER-287 weekly group (17.7%) (P = .024 for vancomycin/SER-287 daily vs placebo/placebo). By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P < .05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group. In the vancomycin groups, a greater number of dose species were detected in stool collected on day 10 and all subsequent time points through 4 weeks post dosing compared with the placebo group (P < .05). A higher number of SER-287 dose species were detected in stool samples on days 7 and 10 from subjects who received daily vs weekly SER-287 doses (P < .05). Changes in fecal microbiome composition and metabolites were associated with both vancomycin/SER-287 groups.
CONCLUSIONS


In this small phase 1b trial of limited duration, the safety and tolerability of SER-287 were similar to placebo. SER-287 after vancomycin was significantly more effective than placebo for induction of remission in patients with active mild to moderate UC. Engraftment of dose species was facilitated by vancomycin preconditioning and daily dosing of SER-287. ClinicalTrials.gov ID NCT02618187.",2020,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","['patients with active mild-to-moderate UC', '58 adults with active mild-to-moderate UC (modified Mayo scores 4-10, endoscopic subscores ≥1', 'active mild to moderate ulcerative colitis', 'patients with ulcerative colitis (UC', 'patients with UC']","['placebo or SER-287', 'vancomycin', 'oral SER-287 or placebo', 'placebo/placebo', 'vancomycin/SER-287 daily vs placebo/placebo', 'preconditioning with oral vancomycin', 'vancomycin followed by SER-287 once weekly or SER-287 once daily', 'placebo/SER-287', 'vancomycin/SER-287', 'vancomycin preconditioning', 'vancomycin preconditioning and daily dosing of SER-287', 'SER-287', 'placebo']","['numbers of SER-287 dose species', 'safety and efficacy of SER-287', 'safety and clinical remission (modified Mayo score ≤ 2; endoscopic subscores 0 or 1', 'microbiome composition and associated metabolites', 'intestinal microbiota', 'SER-287 engraftment', 'number of dose species', 'safety and tolerability of SER-287', 'fecal microbiome composition and metabolites', 'adverse events', 'clinical remission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1709632', 'cui_str': 'Precondition'}, {'cui': 'C0360373', 'cui_str': 'Vancomycin-containing product in oral dose form'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",58.0,0.414313,"By day 7, higher numbers of SER-287 dose species were detected in stool samples from all SER-287 groups compared with the placebo group (P<.05), but this difference was not maintained beyond day 7 in the placebo/SER-287 weekly group.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Henn', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts. Electronic address: mhenn@serestherapeutics.com.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': ""O'Brien"", 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Research Institute, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Huttenhower', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts; (5)Borland Groover Clinic, Jacksonville, FL.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Wortman', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'McGovern', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Wang-Weigand', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Lichter', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Chafee', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Ford', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bernardo', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Simmons', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Amelia D', 'Initials': 'AD', 'LastName': 'Tomlinson', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Cook', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Pomerantz', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Bharat K', 'Initials': 'BK', 'LastName': 'Misra', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Auninš', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Trucksis', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts.'}]",Gastroenterology,['10.1053/j.gastro.2020.07.048']
2915,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2021,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
2916,32763002,"Response to Letter to Editor ""Effects of handwriting exercise on functional outcome in parkinson disease: A randomized controlled trial"".",,2020,,['parkinson disease'],['handwriting exercise'],['functional outcome'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0973615,,[],Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.07.001']
2917,32763006,Polyethylene Wear With Ceramic and Metal Femoral Heads at 5 Years: A Randomized Controlled Trial With Radiostereometric Analysis.,"BACKGROUND


A common bearing combination in total hip arthroplasty today is a metal femoral head articulating with polyethylene in the cup. Ceramic heads are thought to be more resistant to third-body damage, and have better wettability and decreased surface roughness, which taken together have been suggested to result in less polyethylene wear. The purpose of this study is to compare the initial creep deformation and follow wear pattern, using radiostereometric analysis, of ceramic and metal femoral heads that articulate with a modern highly cross-linked polyethylene cup liner.
METHODS


Fifty patients with primary osteoarthritis and scheduled for an uncemented total hip arthroplasty were randomized 1:1 to either a ceramic (BIOLOX delta) or a metal (CoCr) femoral head. The patients were followed up for 5 years with repeated radiostereometric analysis examinations (postoperatively, then at 14 days, 3, 12, 24, and 60 months), as well as a hip-specific outcome questionnaire.
RESULTS


During the first 3 months both groups showed expected creep within the liner of 0.12 mm (standard deviation 0.03) for the ceramic and 0.08 mm (standard deviation 0.02) for the metal heads. Between 3 months and 5 years there was very little wear of the liner in either group, corresponding to 0.003 mm/y for ceramic and 0.007 mm/y for metal heads. There was no difference in cup migration or clinical outcome between the groups and no cups were revised.
CONCLUSION


With the introduction of modern highly cross-linked polyethylene, the ceramic head demonstrates no superiority when it comes to either early deformation or polyethylene wear compared with the metal head.",2020,"There was no difference in cup migration or clinical outcome between the groups and no cups were revised.
","['at 5 Years', 'Fifty patients with primary osteoarthritis and scheduled for an uncemented total hip arthroplasty']","['modern highly cross-linked polyethylene', 'Polyethylene Wear With Ceramic and Metal Femoral Heads', 'ceramic (BIOLOX delta) or a metal (CoCr) femoral head']",['cup migration or clinical outcome'],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]","[{'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",50.0,0.0929279,"There was no difference in cup migration or clinical outcome between the groups and no cups were revised.
","[{'ForeName': 'Halldor', 'Initials': 'H', 'LastName': 'Bergvinsson', 'Affiliation': 'Department of Orthopedics, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundberg', 'Affiliation': 'Department of Orthopedics, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Flivik', 'Affiliation': 'Department of Orthopedics, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.06.057']
2918,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2021,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
2919,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
2920,32762637,Colorectal Cancer Screening Patient Navigation for Patients with Mental Illness and/or Substance Use Disorder: Pilot Randomized Control Trial.,"OBJECTIVE


Colorectal cancer (CRC) is the second leading cause of cancer death in the US. Screening has decreased CRC mortality. However, disadvantaged patients, particularly those with mental illness or substance use disorder (SUD), are less likely to be screened. The aim of this trial was to evaluate the impact of a patient navigation program on CRC screening in patients with mental illness and/or SUD.
METHODS


A pilot randomized nonblinded controlled trial was conducted from January to June 2017 in an urban community health center serving a low-income population. We randomized 251 patients aged 50-74 years with mental illness and/or SUD diagnosis overdue for CRC screening to intervention ( n  = 126) or usual care ( n  = 125) stratified by mental illness, SUD, or dual diagnosis. Intervention group patients received a letter followed by a phone call from patient navigators. Navigators helped patients overcome their individual barriers to CRC screening including: education, scheduling, explanation of bowel preparation, lack of transportation or accompaniment to appointments. If patient refused colonoscopy, navigators offered fecal occult blood testing. The main measure was proportion of patients completing CRC screening in intervention and usual care groups.
RESULTS


Navigators contacted 85 patients (67%) in the intervention group and 26 declined to participate. In intention-to treat analysis, more patients in the intervention group received CRC screening than in the usual care group, 19% versus 10.4% ( p  = .04). Among 56 intervention patients who received navigation, 19 completed screening (33.9% versus 10.4% in the control group,  p  = .001). In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group ( p  = .05).
CONCLUSIONS


A patient navigation program improved CRC screening rates in patients with mental illness and/or SUD. Larger studies in diverse care settings are needed to demonstrate generalizability and explore which modality of CRC screening is most acceptable and which navigator activities are most effective for this vulnerable population.
TRIALS REGISTRATION NUMBER


2016P001322.",2020,"In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group ( p  = .05).
","['Colorectal cancer (CRC', 'patients with mental illness and/or SUD', '251 patients aged 50-74 years with mental illness and/or SUD diagnosis overdue for CRC screening to intervention ( n \u2009=\u2009126) or usual care ( n \u2009=\u2009125) stratified by mental illness, SUD, or dual diagnosis', 'January to June 2017 in an urban community health center serving a low-income population', 'disadvantaged patients, particularly those with mental illness or substance use disorder (SUD', 'Patients with Mental Illness and/or Substance Use Disorder']","['patient navigation program', 'letter followed by a phone call from patient navigators', 'Colorectal Cancer Screening Patient Navigation']","['CRC mortality', 'CRC screening', 'CRC screening rates']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",251.0,0.119177,"In the subgroup of patients with SUD, 20% in the intervention group were screened compared to none in the usual care group ( p  = .05).
","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Abuelo', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Knudsen', 'Affiliation': 'Massachusetts General Hospital Institute for Technology Assessment, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morrill', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Corona', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Derri', 'Initials': 'D', 'LastName': 'Shtasel', 'Affiliation': 'Massachusetts General Hospital, Division of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Percac-Lima', 'Affiliation': 'Massachusetts General Hospital, Division of General Internal Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of dual diagnosis,['10.1080/15504263.2020.1802542']
2921,32763872,Translatability of a Wearable Technology Intervention to Increase Adolescent Physical Activity: Mixed Methods Implementation Evaluation.,"BACKGROUND


Wearable technology interventions combined with digital behavior change resources provide opportunities to increase physical activity in adolescents. The implementation of such interventions in real-world settings is unknown. The Raising Awareness of Physical Activity (RAW-PA) study was a 12-week cluster randomized controlled trial targeting inactive adolescents attending schools in socioeconomically disadvantaged areas of Melbourne, Australia. The aim was to increase moderate- to vigorous-intensity physical activity using (1) a wrist-worn Fitbit Flex and app, (2) weekly challenges, (3) digital behavior change resources, and (4) email or text message alerts.
OBJECTIVE


This paper presents adolescents' and teachers' perceptions of RAW-PA in relation to program acceptability, feasibility and perceived impact, adolescent engagement and adherence, and the potential for future scale-up.
METHODS


A mixed methods evaluation of the RAW-PA study assessed acceptability, engagement, feasibility, adherence, and perceived impact. A total of 9 intervention schools and 144 intervention adolescents were recruited. Only adolescents and teachers (n=17) in the intervention group were included in the analysis. Adolescents completed web-based surveys at baseline and surveys and focus groups postintervention. Teachers participated in interviews postintervention. Facebook data tracked engagement with web-based resources. Descriptive statistics were reported by sex. Qualitative data were analyzed thematically.
RESULTS


Survey data were collected from 142 adolescents at baseline (mean age 13.7 years, SD 0.4 years; 51% males) and 132 adolescents postintervention. A total of 15 focus groups (n=124) and 9 interviews (n=17) were conducted. RAW-PA had good acceptability among adolescents and teachers. Adolescents perceived the intervention content as easy to understand (100/120, 83.3%) and the Fitbit easy to use (112/120; 93.3%). Half of the adolescents perceived the text messages to be useful (61/120; 50.8%), whereas 47.5% (57/120) liked the weekly challenges and 38.3% (46/120) liked the Facebook videos. Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention. Adolescents perceived the Fitbit Flex to increase their physical activity motivation (85/120, 70.8%) and awareness (93/119, 78.2%). The web-based delivery facilitated implementation of the intervention, although school-level policies restricting phone use were perceived as potential inhibitors to program roll-out.
CONCLUSIONS


RAW-PA showed good acceptability among adolescents attending schools in socioeconomically disadvantaged areas and their teachers. Low levels of teacher burden enhanced their perceptions concerning the feasibility of intervention delivery. Although adolescents perceived that RAW-PA had short-term positive effects on their motivation to be physically active, adolescent adherence and engagement were low. Future research exploring the feasibility of different strategies to engage adolescents with wearable technology interventions and ways of maximizing system-level embeddedness of interventions in practice would greatly advance the field.",2020,Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention.,"['A total of 15 focus groups (n=124) and 9 interviews (n=17) were conducted', 'adolescents attending schools in socioeconomically disadvantaged areas and their teachers', 'Only adolescents and teachers (n=17) in the intervention group were included in the analysis', 'inactive adolescents attending schools in socioeconomically disadvantaged areas of Melbourne, Australia', 'A total of 9 intervention schools and 144 intervention adolescents', '142 adolescents at baseline (mean age 13.7 years, SD 0.4 years; 51% males) and 132 adolescents postintervention', 'adolescents']","['moderate- to vigorous-intensity physical activity using (1) a wrist-worn Fitbit Flex and app, (2) weekly challenges, (3) digital behavior change resources, and (4) email or text message alerts', 'Wearable Technology Intervention', 'RAW-PA']","['acceptability, engagement, feasibility, adherence, and perceived impact', 'good acceptability', 'Facebook engagement', 'physical activity motivation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",17.0,0.0406149,Facebook engagement declined over time; only 18.6% (22/118) of adolescents self-reported wearing the Fitbit Flex daily postintervention.,"[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Koorts', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Timperio', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Ball', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Macfarlane', 'Affiliation': 'Learning Futures, Deakin University, Geelong, Australia.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Lai', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Chappel', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Ridgers', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Burwood, Australia.'}]",Journal of medical Internet research,['10.2196/13573']
2922,32768259,No Differences in Midterm Sports Participation or Functional Scores After Total Hip Arthroplasty by Posterolateral Vs Anterolateral Approach.,"BACKGROUND


Patients undergoing total hip arthroplasty (THA) frequently question surgeons on return to sports. We compared midterm sports participation and functional scores after THA by posterolateral approach (PLA) vs anterolateral approach (ALA).
METHODS


Of 1381 patients who underwent uncemented ceramic-on-ceramic THA for primary osteoarthritis, 503 were excluded because of preoperative or postoperative lower limb surgery, leaving 594 operated by PLA and 284 by ALA. Forgotten Joint Score (FJS), Oxford Hip Score (OHS), satisfaction, as well as motivation, participation, and discomfort regarding 22 sports were collected. A 1:1 matching was performed to obtain 2 groups of PLA and ALA patients with similar age, gender, body mass index, and sports motivation.
RESULTS


Matching yielded 2 equal groups of 259 patients. There were no significant differences in FJS (P = .057), OHS (P = .685), satisfaction (P = .369), or rates of participation in light (P = .999), moderate (P = .632), or strenuous sports (P = .284). Participation in strenuous sports was reported by 50 PLA (19%) and 61 ALA (24%) patients, with differences for downhill skiing (22 vs 39), running (10 vs 19), and cross-country skiing (18 vs 10). More than 50% of motivated patients practiced most of their sports. Severe discomfort was reported similarly in PLA and ALA patients, mainly during running (13 vs 11), team ball games (9 vs 7), and downhill skiing (7 vs 8).
CONCLUSION


There were no significant differences between PLA and ALA patients in terms of OHS, FJS, satisfaction, or sports participation rates. There is little or no evidence to promote an approach based on sports participation or functional improvement.
LEVEL OF EVIDENCE


Level III, comparative study.",2020,"There were no significant differences between PLA and ALA patients in terms of OHS, FJS, satisfaction, or sports participation rates.","['1381 patients who underwent uncemented ceramic-on-ceramic THA for primary osteoarthritis, 503 were excluded because of preoperative or postoperative lower limb surgery, leaving 594 operated by PLA and 284 by ALA', 'Patients undergoing total hip arthroplasty (THA) frequently question surgeons on return to sports']",['THA by posterolateral approach (PLA) vs anterolateral approach (ALA'],"['Severe discomfort', 'rates of participation in light', 'Midterm Sports Participation or Functional Scores', 'Forgotten Joint Score (FJS), Oxford Hip Score (OHS), satisfaction, as well as motivation, participation, and discomfort regarding 22 sports', 'satisfaction', 'OHS, FJS, satisfaction, or sports participation rates', 'OHS', 'FJS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",22.0,0.0427256,"There were no significant differences between PLA and ALA patients in terms of OHS, FJS, satisfaction, or sports participation rates.","[{'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Bonnin', 'Affiliation': 'Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Ramsay Santé, Lyon, France; Artro Institute, Lyon, France.'}, {'ForeName': 'Michel-Henri', 'Initials': 'MH', 'LastName': 'Fessy', 'Affiliation': 'Artro Institute, Lyon, France; Department of Orthopaedic Surgery and Sports Medicine, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Van Rooij', 'Affiliation': 'ReSurg SA, Nyon, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Nover', 'Affiliation': 'ReSurg SA, Nyon, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Ait-Si-Selmi', 'Affiliation': 'Hôpital Privé Jean Mermoz, Centre Orthopédique Santy, Ramsay Santé, Lyon, France; Artro Institute, Lyon, France.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.009']
2923,32768874,Intermittent Motivational Interviewing and Transdiagnostic CBT for Anxiety: A Randomized Controlled Trial.,"Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI significantly increases the length of treatment and numerous studies note that the effectiveness of pre-treatment MI subsides over time. The current study adapted an already established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each, with the option of including additional MI if resistance arose in therapy. Thirty-six treatment seeking adults with principal anxiety disorder diagnosis were randomly assigned to receive intermittent MI and tCBT (iMI + tCBT) or tCBT and psychoeducation. Results indicated that the iMI + tCBT condition significantly outperformed the tCBT condition on several primary outcome variables. While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning. These effects were not moderated by baseline motivation or baseline ambivalence. The study also found that the iMI + tCBT condition showed significantly greater improvement to comorbid conditions and greater reduction in self-report depressive symptoms. The inclusion of MI did not impact participant drop out. This study provides further support for integrating MI and tCBT and highlights that even small doses of MI can improve treatment outcomes, without increasing length of usual therapy. Limitations and future research options are also discussed.",2020,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","['for Anxiety', 'Thirty-six treatment seeking adults with principal anxiety disorder diagnosis']","['Intermittent Motivational Interviewing and Transdiagnostic CBT', 'Cognitive Behavior Therapy (CBT', 'Motivational Interviewing (MI', 'intermittent MI and tCBT (iMI\u202f+\u202ftCBT) or tCBT and psychoeducation']","['self-report depressive symptoms', ""composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning""]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",36.0,0.0207886,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Marker', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Bronte E', 'Initials': 'BE', 'LastName': 'Corbett', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: Peter.Norton@monash.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102276']
2924,32768512,Abuse liability of cigarettes with very low nicotine content in pregnant cigarette smokers.,"The U.S. Food and Drug Administration has proposed reducing the nicotine content of cigarettes to a minimally-addictive level. To our knowledge, this study is the first to examine how pregnant smokers respond to very low nicotine content (VLNC) cigarettes. In Phase 1, participants blindly sampled two VLNC cigarettes (0.4 and 2.4 mg/g of tobacco) and their usual brand (UB) cigarette in separate sessions, then completed a behavioral economic simulation task and measures of subjective effects, craving/withdrawal, and smoking topography. Phase 2 directly compared the relative reinforcing effects of the cigarettes using concurrent choice testing. All possible dose-pair combinations were tested in separate sessions where puffs were earned ad libitum by clicking the code associated with their preferred cigarette 10 times. Phase 3 tested the 0.4 mg/g-UB dose-pair where UB puffs could be earned with a progressively incremented number of clicks (maximum 8400). Ten pregnant smokers in Burlington, VT and Baltimore, MD participated in 2017-2018. Regarding abuse liability, participants chose the 0.4-mg/g dose less than UB (22% vs. 78%) during concurrent choice testing and the 0.4-mg/g dose sustained less demand than the 2.4-mg/g and UB doses on the simulation task. Positive subjective effects were also lower for both VLNC cigarettes vs. UB. Each cigarette reduced nicotine craving/withdrawal and no significant changes indicative of compensatory smoking were noted. Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking. Studies of extended exposure to VLNCs in pregnant women are warranted.",2020,Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking.,"['Pregnant Cigarette Smokers', 'Ten pregnant smokers in Burlington, VT and Baltimore, MD participated in 2017-2018', 'pregnant smokers respond to very low nicotine content (VLNC) cigarettes', 'pregnant smokers', 'pregnant women']",[],"['compensatory smoking', 'abuse liability', 'Positive subjective effects']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",10.0,0.0143412,Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking.,"[{'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: sarah.heil@uvm.edu.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: cecilia.bergeria@uvm.edu.'}, {'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224-6823, United States of America. Electronic address: dlee214@jhmi.edu.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: janice.bunn@uvm.edu.'}, {'ForeName': 'Roxanne F', 'Initials': 'RF', 'LastName': 'Harfmann', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: roxanne.harfmann@uvm.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: john.hughes@med.uvm.edu.'}, {'ForeName': 'Haley J', 'Initials': 'HJ', 'LastName': 'Tetreault', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: haley.tetreault@uvm.edu.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: stephen.higgins@uvm.edu.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106227']
2925,32770491,Clinical outcomes after aphakic versus aphakic/pseudophakic intraoperative aberrometry in cataract surgery with toric IOL implantation.,"PURPOSE


To determine if there was a clinically significant difference in clinical outcomes after toric IOL implantation based on intraoperative aberrometry (IA), where eyes were measured either in the aphakic state only or both the aphakic and pseudophakic states.
METHODS


A prospective, randomized, contralateral eye study was performed at one site in Poughkeepsie, NY, USA. Subjects included patients presenting for uncomplicated bilateral cataract surgery eligible for toric lens implantation with regular corneal astigmatism in both eyes whose toric IOL implantation was based on IA. One eye was measured when aphakic and the other when both aphakic and pseudophakic. The primary outcome measure was the magnitude of residual refractive astigmatism. Secondary measures included the percentage of eyes with 0.50D or less of residual refractive astigmatism, the spherical equivalent refraction and the time for IA measurement.
RESULTS


Mean residual refractive astigmatism was not statistically significantly different between groups (0.32D ± 0.46D IA_1 vs. 0.23D ± 0.35D IA_2, p = 0.25), nor was the percentage of eyes with a residual refractive cylinder of 0.50D or less (94% in both groups, p = 1.0). The average time to measure the pseudophakic eye was 3 min, 46 s. Aphakic IA measurements appeared to produce better spherical equivalent refractive results relative to preoperative calculations.
CONCLUSION


Pseudophakic IA measurements took nearly 4 min per case. Residual refractive astigmatism was not appreciably lower when pseudophakic IA measurements were made after aphakic IA measurements, which suggests aphakic IA measurements alone provide good clinical results with toric IOLs.",2020,"Residual refractive astigmatism was not appreciably lower when pseudophakic IA measurements were made after aphakic IA measurements, which suggests aphakic IA measurements alone provide good clinical results with toric IOLs.","['cataract surgery with toric IOL implantation', 'Subjects included patients presenting for uncomplicated bilateral cataract surgery eligible for']","['toric IOL implantation', 'aphakic versus aphakic/pseudophakic intraoperative aberrometry', 'toric lens implantation with regular corneal astigmatism']","['Mean residual refractive astigmatism', 'average time to measure the pseudophakic eye', 'percentage of eyes with 0.50D or less of residual refractive astigmatism, the spherical equivalent refraction and the time for IA measurement', 'magnitude of residual refractive astigmatism']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C2717991', 'cui_str': 'Aberrometry'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C2717991', 'cui_str': 'Aberrometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449286', 'cui_str': 'Degree'}]",,0.0833763,"Residual refractive astigmatism was not appreciably lower when pseudophakic IA measurements were made after aphakic IA measurements, which suggests aphakic IA measurements alone provide good clinical results with toric IOLs.","[{'ForeName': 'Satish S', 'Initials': 'SS', 'LastName': 'Modi', 'Affiliation': 'Seeta Eye Centers, Poughkeepsie, NY, USA. SModieyes@aol.com.'}]",International ophthalmology,['10.1007/s10792-020-01509-y']
2926,32770612,Preventive use of gabapentin to decrease pain and systemic symptoms in patients with head and neck cancer undergoing chemoradiation.,"BACKGROUND


Radiation for patients with head and neck cancer (HNC) is associated with painful mucositis that impacts the delivery of treatment and contributes to high symptom burden.
METHODS


This was a prospective, randomized pilot trial. Eligible patients received primary or adjuvant chemoradiation. Patients were randomized to usual care vs usual care plus gabapentin titrated to drug tolerance during radiation. Patients completed a symptom survey at baseline and weekly during therapy.
RESULTS


Seventy-nine patients were enrolled in the study (38 control, 41 treatment). At interim analysis, gabapentin use resulted in a decrease in pain (P = .004), with the biggest decreases being in the latter weeks of therapy. By week 7, the median pain score in the treatment group was below the 0.25 quantile of the control group.
CONCLUSION


Prophylactic use of gabapentin during chemoradiation for HNC patients resulted in a decrease in pain, neurosensory symptoms, and general systemic symptoms.",2020,"By week 7, the median pain score in the treatment group was below the 0.25 quantile of the control group.
","['patients with head and neck cancer undergoing chemoradiation', 'Seventy-nine patients were enrolled in the study (38 control, 41 treatment', 'patients with head and neck cancer (HNC']","['usual care vs usual care plus gabapentin', 'gabapentin', 'primary or adjuvant chemoradiation']","['pain, neurosensory symptoms, and general systemic symptoms', 'pain and systemic symptoms', 'median pain score', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",79.0,0.0409428,"By week 7, the median pain score in the treatment group was below the 0.25 quantile of the control group.
","[{'ForeName': 'Derek K', 'Initials': 'DK', 'LastName': 'Smith', 'Affiliation': 'Department of Biostatistics and Oral & Maxillofacial Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cmelak', 'Affiliation': 'Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Niermann', 'Affiliation': 'Department of Radiation Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghiam', 'Affiliation': 'Department of Otolaryngology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Lou', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Department of Medicine, Oncology Division, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gibson', 'Affiliation': 'Department of Medicine, Oncology Division, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hawkins', 'Affiliation': 'Department of Medicine, Oncology Division, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, Oncology Division, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]",Head & neck,['10.1002/hed.26407']
2927,32779497,"Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality in Clinical Trials of Time-Constrained Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention.","Background The net clinical benefit of dual antiplatelet therapy (DAPT) reflects the paradoxical effects of an increased risk of bleeding and a reduced risk of major adverse cardiovascular events. A time-constrained approach to DAPT has been recently investigated in 5 multicenter trials including GLOBAL LEADERS, STOPDAPT2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2), SMART-CHOICE, TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention), and TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome). Methods and Results We undertook a pooled analysis of these trials to assess the overall associations between time-constrained P2Y12 inhibitor monotherapy (aspirin-free regimen) for bleeding events, major adverse cardiovascular events, and all-cause mortality as compared to standard care with DAPT for at least 12 months post-percutaneous coronary intervention. We implemented a DerSimonian and Laird random effects meta-analysis using the metafor package in R. 32 361 randomized trial participants, including 16 898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available. P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61). The estimates of the effect of P2Y12 inhibitor monotherapy on the HR were also favorable for major adverse cardiovascular events (0.88; 95% CI, 0.77-1.02) and all-cause mortality (0.85; 95% CI, 0.71-1.03). Conclusions Compared with DAPT for 12 months post-percutaneous coronary intervention, P2Y12 inhibitor monotherapy from 1 to 3 months substantially reduces the risk of major and fatal bleeding and, in addition, confers potentially protective effects, for major adverse cardiovascular events and all-cause mortality. Considering patient safety, the results support a strategy of DAPT for 1 to 3 months followed by aspirin-free P2Y12 inhibitor monotherapy.",2020,"P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61).","['High-Risk Patients', 'R. 32\u2009361 randomized trial participants, including 16\xa0898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available', 'for Acute Coronary Syndrome']","['aspirin-free P2Y12 inhibitor monotherapy', 'STOPDAPT2', 'DAPT', 'Dual Antiplatelet Therapy', 'New Generation Sirolimus Stent', 'P2Y12 inhibitor monotherapy', 'Everolimus-Eluting Cobalt-Chromium Stent-2), SMART-CHOICE, TWILIGHT', 'Ticagrelor With Aspirin', 'dual antiplatelet therapy (DAPT', 'TICO (Ticagrelor Monotherapy', 'P2Y12 inhibitor monotherapy (aspirin-free regimen']","['Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality', 'risk reduction', 'reduced risk for bleeding', 'major adverse cardiovascular events', 'bleeding events, major adverse cardiovascular events', 'risk of major and fatal bleeding']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",,0.0468397,"P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61).","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Ramsay', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Clydebank United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017109']
2928,32779505,"Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers.","Background Epeleuton is 15-hydroxy eicosapentaenoic acid ethyl ester, a second-generation synthetic n-3 fatty acid derivative of eicosapentaenoic acid. The primary objective was to assess the effect of epeleuton on markers of nonalcoholic fatty liver disease (NAFLD) with post hoc analyses of cardiometabolic markers. Methods and Results In a multicenter, randomized, double-blind, placebo-controlled trial, 96 adults with nonalcoholic fatty liver disease and body mass index 25 to 40 were randomized in a 1:1:1 ratio to receive epeleuton 2 g/day, epeleuton 1 g/day, or placebo for 16 weeks. A total of 27% of patients had diabetes mellitus. Primary end points of changes in alanine aminotransferase and liver stiffness did not improve at week 16. Secondary and post hoc analyses investigated changes in cardiometabolic markers. Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol. Despite a low mean baseline hemoglobin A1C (HbA 1C ; 6.3±1.3%), epeleuton 2 g/day significantly decreased HbA 1c  (-0.4%;  P =0.026). Among patients with baseline HbA 1c  >6.5%, epeleuton 2 g/day decreased HbA 1c  by 1.1% ( P =0.047; n=26). Consistent dose-dependent reductions were observed for fasting plasma glucose, insulin, and insulin resistance indices. Epeleuton 2 g/day decreased circulating markers of cardiovascular risk and endothelial dysfunction. Epeleuton was well tolerated, with a safety profile not different from placebo. Conclusions While epeleuton did not meet its primary end points on alanine aminotransferase or liver stiffness, it significantly decreased triglycerides, HbA 1C , plasma glucose, and inflammatory markers. These data suggest epeleuton may have potential for cardiovascular risk reduction and nonalcoholic fatty liver disease by simultaneously targeting hypertriglyceridemia, hyperglycemia, and systemic inflammation. Further trials are planned. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02941549.",2020,"Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol.",['96 adults with nonalcoholic fatty liver disease and body mass index 25 to 40'],"['Registration URL', 'Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid', 'epeleuton 2\xa0g/day, epeleuton 1\xa0g/day, or placebo', 'placebo']","['cardiometabolic markers', 'circulating markers of cardiovascular risk and endothelial dysfunction', 'triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol', 'nonalcoholic fatty liver disease (NAFLD', 'Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers', 'fasting plasma glucose, insulin, and insulin resistance indices', 'diabetes mellitus', 'triglycerides, HbA 1C , plasma glucose, and inflammatory markers', 'alanine aminotransferase and liver stiffness', 'alanine aminotransferase or liver stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",96.0,0.456088,"Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Climax', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham United Kingdom.'}, {'ForeName': 'Moayed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Weissbach', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coughlan', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016334']
2929,32778913,"Acute mechanical, physiological and perceptual responses in older men to traditional-set or different cluster-set configuration resistance training protocols.","PURPOSE


The aims of this study were to compare mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses in older men to traditional-set or different cluster-set configuration resistance training protocols.
METHODS


In a randomized cross-over design, 20 healthy old men (aged 67.2 ± 2.1 years) completed four resistance training sessions using the back squat exercise loaded with optimal power loads. Training configurations were: traditional (TRA), three sets of six repetitions with 120-s rest between each set; Cluster-set 1 (CLU1), 24 single-repetition clusters with 10 s of rest after every cluster; Cluster-set 2 (CLU2), 12 double-repetition clusters with 20-s rest after every cluster; and Cluster-set 4 (CLU4), 6 quadruple-repetition clusters with 40-s rest after every cluster.
RESULTS


Cluster-set configurations resulted in greater power outputs compared to traditional-set configuration (range 2.6-9.2%, all p [Formula: see text] 0.07 for main effect and protocol [Formula: see text] set interactions). CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU, all p [Formula: see text] 0.006 for pairwise comparisons) and lower ratings of fatigue (range - 0.15 to - 4 AU, all p [Formula: see text] 0.012 for pairwise comparisons) compared to TRA and CLU4. Finally, an absolute preference for CLU2 was reported.
CONCLUSIONS


Findings presented here support the prescription of CLU2 as an optimal resistance training configuration for trained older men using the back squat.",2020,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","['trained older men using the back squat', '20 healthy old men (aged 67.2\u2009±\u20092.1\xa0years', 'older men to traditional-set or different cluster-set configuration resistance training protocols', 'older men']","['CLU1 and CLU2', 'resistance training sessions using the back squat exercise loaded with optimal power loads']","['heart rate', 'lower ratings of fatigue', 'mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses', 'Acute mechanical, physiological and perceptual responses']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.043265,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK. antonio.delloiacono@uws.ac.uk.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Martone', 'Affiliation': ""Universita' Degli Studi di Napoli (Dipartimento di Science Motorie e Benessere), Naples, Italy.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04453-y']
2930,32780025,The Acceptability and Impact of the Xploro Digital Therapeutic Platform to Inform and Prepare Children for Planned Procedures in a Hospital: Before and After Evaluation Study.,"BACKGROUND


There is increasing interest in finding novel approaches to improve the preparation of children for hospital procedures such as surgery, x-rays, and blood tests. Well-prepared and informed children have better outcomes (less procedural anxiety and higher satisfaction). A digital therapeutic (DTx) platform (Xploro) was developed with children to provide health information through gamification, serious games, a chatbot, and an augmented reality avatar.
OBJECTIVE


This before and after evaluation study aims to assess the acceptability of the Xploro DTx and examine its impact on children and their parent's procedural knowledge, procedural anxiety, and reported experiences when attending a hospital for a planned procedure.
METHODS


We used a mixed methods design with quantitative measures and qualitative data collected sequentially from a group of children who received standard hospital information (before group) and a group of children who received the DTx intervention (after group). Participants were children aged between 8 and 14 years and their parents who attended a hospital for a planned clinical procedure at a children's hospital in North West England. Children and their parents completed self-report measures (perceived knowledge, procedural anxiety, procedural satisfaction, and procedural involvement) at baseline, preprocedure, and postprocedure.
RESULTS


A total of 80 children (n=40 standard care group and n=40 intervention group) and their parents participated in the study; the children were aged between 8 and 14 years (average 10.4, SD 2.27 years) and were attending a hospital for a range of procedures. The children in the intervention group reported significantly lower levels of procedural anxiety before the procedure than those in the standard group (two-tailed t 63.64 =2.740; P=.008). The children in the intervention group also felt more involved in their procedure than those in the standard group (t 75 =-2.238; P=.03). The children in the intervention group also reported significantly higher levels of perceived procedural knowledge preprocedure (t 59.98 =-4.892; P=.001) than those in the standard group. As for parents, those with access to the Xploro intervention reported significantly lower levels of procedural anxiety preprocedure than those who did not (t 68.51 =1.985; P=.05). During the semistructured write and tell interviews, children stated that they enjoyed using the intervention, it was fun and easy to use, and they felt that it had positively influenced their experiences of coming to the hospital for a procedure.
CONCLUSIONS


This study has shown that the DTx platform, Xploro, has a positive impact on children attending a hospital for a procedure by reducing levels of procedural anxiety. The children and parents in the intervention group described Xploro as improving their experiences and being easy and fun to use.",2020,The children and parents in the intervention group described Xploro as improving their experiences and being easy and fun to use.,"['80 children (n=40 standard care group and n=40 intervention group) and their parents participated in the study; the children were aged between 8 and 14 years (average 10.4, SD 2.27 years) and were attending a hospital for a range of procedures', ""Participants were children aged between 8 and 14 years and their parents who attended a hospital for a planned clinical procedure at a children's hospital in North West England""]","['DTx intervention', 'standard hospital information', 'digital therapeutic (DTx) platform (Xploro']","['levels of procedural anxiety', 'procedural anxiety preprocedure', 'higher levels of perceived procedural knowledge preprocedure', 'self-report measures (perceived knowledge, procedural anxiety, procedural satisfaction, and procedural involvement) at baseline, preprocedure, and postprocedure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0216817', 'cui_str': 'dendrotoxin K'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",80.0,0.0501019,The children and parents in the intervention group described Xploro as improving their experiences and being easy and fun to use.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bray', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Sharpe', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Gichuru', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Peter-Marc', 'Initials': 'PM', 'LastName': 'Fortune', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Blake', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Appleton', 'Affiliation': 'Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17367']
2931,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
2932,32779140,Impact of an Opt-In eConsult Program on Primary Care Demand for Specialty Visits: Stepped-Wedge Cluster Randomized Implementation Study.,"BACKGROUND


eConsult programs have been instituted to increase access to specialty expertise. Opt-in choice eConsult programs maintain primary care physician (PCP) autonomy to decide whether to utilize eConsults versus traditional specialty referrals, but little is known about how this intervention may impact PCP eConsult adoption and traditional referral demand.
OBJECTIVE


We assessed the feasibility of implementing an opt-in choice eConsult program and examined whether this intervention reduces demand for in-person visits for primary care patients requiring specialty expertise.
DESIGN


Stepped-wedge, cluster randomized trial conducted from July 2018 to June 2019.
PARTICIPANTS


Sixteen primary care practices in a large, urban academic health care system.
INTERVENTION


Our intervention was an opt-in choice eConsult available in addition to traditional specialty referral; our implementation strategy included in-person training, audit and feedback, and incentive payments.
MAIN MEASURES


Our implementation outcome measure was the eConsult rate: weekly proportion of eConsults per PCP visit at each site. Our intervention outcome measure was traditional referral rate: weekly proportion of referrals per PCP visit at each site. We also assessed PCP experiences with questionnaires.
KEY RESULTS


Of 305,915 in-person PCP visits, there were 31,510 traditional referrals to specialties participating in the eConsult program, and 679 eConsults. All but one primary care site utilized the opt-in choice eConsult program, with a weekly rate of 0.05 eConsults per 100 PCP visits by the end of the study period. The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults. PCPs were generally satisfied with the eConsult program and valued prompt provider-to-provider communication.
CONCLUSIONS


Implementation of an opt-in choice eConsult program resulted in widespread PCP adoption; however, this did not decrease the demand for traditional referrals. Future studies should evaluate different strategies to incentivize and increase eConsult utilization while maintaining PCP choice.",2020,The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults.,"['July 2018 to June 2019', 'Of 305,915 in-person PCP visits', '31,510 traditional referrals to specialties participating in the eConsult program, and 679 eConsults', 'Sixteen primary care practices in a large, urban academic health care system', 'primary care patients requiring specialty expertise']",['Opt-In eConsult Program'],"['eConsult rate: weekly proportion of eConsults per PCP visit', 'traditional referral rate', 'traditional referral rate: weekly proportion of referrals per PCP visit at each site']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",,0.028566,The weekly rate of traditional referrals was 11 per 100 PCP visits at the end of the study period; this represents a significant increase in traditional referral rate after implementation of eConsults.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Rikin', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA. Srikin@montefiore.org.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lipsey', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Deluca', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Epstein', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Tomer', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06101-9']
2933,32776533,One-year results of 0.01% atropine with orthokeratology (AOK) study: a randomised clinical trial.,"PURPOSE


To report the 1-year results of an investigation into whether there is an additive effect between 0.01% atropine and orthokeratology (ortho-k), in a single-masked, two-arm, randomised controlled trial: Combined Atropine with Orthokeratology (AOK) for myopia control study (ClinicalTrials.gov number: NCT02955927).
METHODS


Chinese children aged between 6 and 11 years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia, were randomly assigned either to an AOK group or ortho-k only (OK) group at a 1:1 ratio. Subjects in the AOK group instilled one drop of 0.01% atropine into each eye, 10 min before nightly wear of ortho-k lenses. The primary outcome, axial elongation, was examined at 6-monthly intervals, along with secondary outcomes including best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography.
RESULTS


29 AOK and 30 OK subjects completed the 1-year visit. The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p = 0.03). A significant between-group difference in axial elongation was observed over the first 6-month period only (p < 0.001), but not over the second period (p = 0.818). At the 1-year visit, increases in mean (S.D.) mesopic and photopic pupil sizes in the AOK group were 0.64 (0.48) mm and 0.36 (0.34) mm, respectively, which were significantly higher than 0.10 (0.50) mm and 0.02 (0.28) mm in the OK group (p < 0.001). At the 6-month visit, a significant moderate negative correlation was found between axial elongation and the increase in photopic pupil size (r = -0.42, p = 0.02) in the AOK group.
CONCLUSIONS


There is an additive effect between 0.01% atropine and ortho-k over one year, with mean axial elongation in the AOK group 0.09 mm slower than that in the OK group. It appears that the additive effect was only during the first six months; a second-year investigation is warranted to determine whether the effect is sustained over time.",2020,"The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p =","['Chinese children aged between 6 and 11\xa0years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia']","['AOK group or ortho-k only (OK', 'atropine and orthokeratology (ortho-k', 'Atropine with Orthokeratology (AOK', 'atropine', 'atropine with orthokeratology']","['overall axial elongation rate', 'mean (S.D.) mesopic and photopic pupil sizes', 'mean axial elongation', 'photopic pupil size', 'best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography', 'axial elongation']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}]",,0.168199,"The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p =","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Alex Lk', 'Initials': 'AL', 'LastName': 'Ng', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Bonnie Nk', 'Initials': 'BN', 'LastName': 'Choy', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'George Pm', 'Initials': 'GP', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Laser Eye Centre, Hong Kong SAR, China.'}, {'ForeName': 'Victor Cp', 'Initials': 'VC', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12722']
2934,32779728,Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.,"INTRODUCTION


Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS


The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION


The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.",2020,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","['patients with COVID-19 and severe hypoxia', '1000 adult patients with COVID-19 receiving ≥10\xa0L/min of oxygen or on']","['Low-dose hydrocortisone', 'mechanical ventilation to intravenous hydrocortisone 200\xa0mg daily vs placebo (0.9% saline', 'Corticosteroids']","['longer time to viral clearance', 'Kryger Jensen and Lange test in the intention to treat population', 'health-related quality of life', 'days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy', 'time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality', 'serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",1000.0,0.37202,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","[{'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjaer', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Carl Johan Steensen', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Steen', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter Buhl', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mik', 'Initials': 'M', 'LastName': 'Wetterslev', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mohr', 'Affiliation': 'Department of Intensive Care, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjaellands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Mette Friberg', 'Initials': 'MF', 'LastName': 'Hitz', 'Affiliation': 'Internal Medicine Department, Endocrinology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lene Surland', 'Initials': 'LS', 'LastName': 'Knudsen', 'Affiliation': 'Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christoffer Grant', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13673']
2935,32772701,Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants With Unilateral Cleft Lip and Palate? A Randomized Controlled Trial.,"OBJECTIVE


The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair.
DESIGN


A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial.
SETTING


All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt.
PARTICIPANTS


Thirty-one, nonsyndromic infants with UCLP.
INTERVENTIONS


The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop scanner producing digital models for outcome assessment.
MAIN OUTCOMES MEASURES


A blinded assessor carried out all the MAD measurements virtually on the produced digital models at the beginning (T1) and after (T2) treatment.
RESULTS


Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group.
CONCLUSIONS


It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.",2020,"Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group.
","['Thirty-one, nonsyndromic infants with UCLP', 'infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair', 'All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt', 'infants with UCLP', 'Infants With Unilateral Cleft Lip and Palate']","['horizontal tape', 'no-treatment (control) or taping groups']",['MADs'],"[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0747108,"Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abd El-Ghafour', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Egypt.'}, {'ForeName': 'Mamdouh A', 'Initials': 'MA', 'LastName': 'Aboulhassan', 'Affiliation': 'Department of Pediatric\xa0Plastic Surgery, Faculty of Medicine, 63526Cairo University, Egypt.'}, {'ForeName': 'Amr Ragab', 'Initials': 'AR', 'LastName': 'El-Beialy', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Egypt.'}, {'ForeName': 'Mona M Salah', 'Initials': 'MMS', 'LastName': 'Fayed', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Egypt.'}, {'ForeName': 'Faten Hussein Kamel', 'Initials': 'FHK', 'LastName': 'Eid', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Gendi', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Egypt.'}, {'ForeName': 'Dawlat', 'Initials': 'D', 'LastName': 'Emara', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, 63526Cairo University, Egypt.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620944757']
2936,32781940,Effects of Inhibition of Nitric Oxide Synthase on Muscular Arteries During Exercise: Nitric Oxide Does Not Contribute to Vasodilation During Exercise or in Recovery.,"Background Basal release of nitric oxide (NO) from the vascular endothelium regulates the tone of muscular arteries and resistance vasculature. Effects of NO on muscular arteries could be particularly important during exercise when shear stress may stimulate increased NO synthesis. Methods and Results We investigated acute effects of NO synthase inhibition on exercise hemodynamics using N G -monomethyl-l-arginine (l-NMMA), a nonselective NO synthase -inhibitor. Healthy volunteers (n=10, 5 female, 19-33 years) participated in a 2-phase randomized crossover study, receiving l-NMMA (6 mg/kg, iv over 5 minutes) or placebo before bicycle exercise (25-150 W for 12 minutes). Blood pressure, cardiac output (measured by dilution of soluble and inert tracers) and femoral artery diameter were measured before, during, and after exercise. At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01). During/after exercise l-NMMA had no significant effect on peripheral resistance, cardiac output, or on femoral artery diameter. Conclusions These results suggest that NO plays little role in modulating muscular artery function during exercise but that it may mediate changes in muscular artery tone immediately before exercise.",2020,"At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01).","['Muscular Arteries', 'Healthy volunteers (n=10, 5 female, 19-33\xa0years']","['receiving l-NMMA', 'N G -monomethyl-l-arginine (l-NMMA', 'NO synthase inhibition', 'nitric oxide (NO', 'Nitric Oxide Synthase', 'placebo before bicycle exercise']","['peripheral resistance, cardiac output, or on femoral artery diameter', 'femoral artery diameter', 'Blood pressure, cardiac output (measured by dilution of soluble and inert tracers) and femoral artery diameter', 'heart rate', 'peripheral vascular resistance', 'mean arterial blood pressure']","[{'cui': 'C0226002', 'cui_str': 'Structure of medium artery'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.205493,"At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': ""O'Gallagher"", 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Shabeeh', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Munir', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Roomi', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Benyu', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guilcher', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Brett', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chowienczyk', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.013849']
2937,32780617,Using Physical Food Transformation to Enhance the Sensory Approval of Children with Autism Spectrum Disorders for Consuming Fruits and Vegetables.,"Introduction:  Children with autistic spectrum disorders (ASD) commonly exhibit aberrant tactile, taste, and smell sensitivity to foods. Food transformation that alters the appearance, texture, and temperature of foods is promising for solving this sensitivity problem.  Objectives:  This study evaluated the effect of physical transformation of fruits and vegetables (FV) to snacks to enhance ASD children's sensory approval for eating them.  Design:  This was a quasiexperimental design study. It lasted for 4 weeks with three episodes of FV exposure to the ASD children per week. The original condition was conducted in the first and fourth week, while intervention was performed in the second and third week.  Settings:  Food exposure took place in schools in a quiet room.  Subjects:  This study recruited 56 ASD children.  Intervention:  Food transformation constituted changing bananas into ice-cream, zucchinis and sweet potatoes into chips, apples and kiwis into popsicles, and carrots into juice.  Outcome Measures:  FV acceptance and habitual consumption were measured at baseline and postintervention.  Results:  ASD children increased their consumption of all FV, but only banana consumption was statistically significant from 55.3 to 78.0 g ( p  < 0.05). For habitual consumption, parents reported increases in all FV consumption for all three measured fruits and 2 of 3 measures of vegetables (pre vs. post mean for bananas: 2.4 vs. 2.9, apples 2.6 vs. 3.2, kiwis 2.4 vs. 2.9, zucchinis 1.9 vs. 2.5, and sweet potatoes 1.8 vs. 2.4;  p  < 0.05).  Conclusion:  Physical changes of foods may improve impaired sensory processing of ASD children to promote their FV acceptance. Project Code: RG 55/2019-2020R.",2020,"ASD children increased their consumption of all FV, but only banana consumption was statistically significant from 55.3 to 78.0 g ( p  < 0.05).","['56 ASD children', 'Children with autistic spectrum disorders (ASD', 'Subjects', 'Children with Autism Spectrum Disorders for Consuming Fruits and Vegetables']","['physical transformation of fruits and vegetables (FV) to snacks', 'Food transformation constituted changing bananas into ice-cream, zucchinis and sweet potatoes into chips, apples and kiwis into popsicles, and carrots into juice', 'Food exposure']","['FV acceptance and habitual consumption', 'banana consumption', 'FV consumption']","[{'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0020747', 'cui_str': 'Ice cream'}, {'cui': 'C0331252', 'cui_str': 'Ipomoea batatas'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0999170', 'cui_str': 'Apteryx'}, {'cui': 'C3853215', 'cui_str': 'Popsicle'}, {'cui': 'C1141640', 'cui_str': 'Carrot'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004722', 'cui_str': 'Banana'}]",56.0,0.0210702,"ASD children increased their consumption of all FV, but only banana consumption was statistically significant from 55.3 to 78.0 g ( p  < 0.05).","[{'ForeName': 'Louisa Ming Yan', 'Initials': 'LMY', 'LastName': 'Chung', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Queenie Pui Sze', 'Initials': 'QPS', 'LastName': 'Law', 'Affiliation': 'School of Nursing, Tung Wah College, Kowloon, Hong Kong.'}, {'ForeName': 'Shirley Siu Ming', 'Initials': 'SSM', 'LastName': 'Fong', 'Affiliation': 'School of Public Health, The University of Hong Kong, Pokfulam, Hong Kong.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0215']
2938,32777552,Evolution of Endoscopic Lesions in Steroid-Refractory Acute Severe Ulcerative Colitis Responding to Infliximab or Cyclosporine.,"BACKGROUND/AIMS


Few data on the evolution of endoscopic findings are available in patients with acute severe ulcerative colitis (ASUC). The aim of this study was to describe this evolution in a prospective cohort.
METHODS


Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing infliximab and cyclosporine were eligible if they achieved steroid-free clinical remission at day 98. Flexible sigmoidoscopies were performed at baseline, days 7, 42 and 98. Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion - were post-hoc calculated. Global endoscopic remission was defined by a UCEIS of 0, and partial endoscopic remission by any UCEIS sub-score of 0.
RESULTS


Among the 55 patients analyzed (29 infliximab and 26 cyclosporine), 49 (83%) had UCEIS ≥6 at baseline at baseline. Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n = 55); p = .004 and p=.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<.001 for both] and at day 98 [78% and 92% vs. 56% (n = 50); p = .007 and p < .001]. Global endoscopic remission rates at day 98 were higher in patients treated with infliximab than with cyclosporine [73% vs. 25% (n = 26 and 24); p < .001].
CONCLUSION


In steroid-refractory ASUC patients responding to a second-line medical therapy, endoscopic remission process started with bleeding remission and was not achieved in half the patients at day 98 for vascular pattern. Infliximab provided a higher endoscopic remission rate than cyclosporine at day 98.",2020,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","['patients with acute severe ulcerative colitis (ASUC', 'Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing']","['infliximab and cyclosporine', 'infliximab or cyclosporine', 'Infliximab', 'infliximab', 'cyclosporine']","['Global endoscopic remission', 'Global endoscopic remission rates', 'Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion ', 'Partial endoscopic remission rates', 'ulcerations/erosions', 'endoscopic remission rate', 'bleeding and ulceration/erosion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.13872,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': ""INSERM CIC 1401, Service d'hépato-gastroentérologie et oncologie digestive, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France. Electronic address: david.laharie@chu-bordeaux.fr.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourreille', 'Affiliation': ""Institut des Maladies de l'Appareil Digestif, Hépato-Gastroentérologie, Hôtel-Dieu, CHU de Nantes, Nantes, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': ""Service des maladies de l'appareil digestif-Endoscopie digestive, Hôpital Claude Huriez, CHRU de Lille, Lille, France.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Allez', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.""}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Bouhnik', 'Affiliation': 'Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Clichy, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Filippi', 'Affiliation': ""Service de Gastroentérologie et Nutrition Clinique, Hôpital de l'Archet 2, CHU de Nice, Nice, France.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': ""INSERM CIC 1401, Service d'hépato-gastroentérologie et oncologie digestive, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Savoye', 'Affiliation': 'UMR 1073, Service de Gastroentérologie, Hôpital Charles Nicolle, CHU de Rouen, Normandie Université-Rouen, Rouen, France.'}, {'ForeName': 'Lucine', 'Initials': 'L', 'LastName': 'Vuitton', 'Affiliation': 'Service de Gastroentérologie, Hôpital Jean Minjoz, CHU de Besançon, Besançon, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Moreau', 'Affiliation': 'Service de Gastro-entérologie et Nutrition, Hôpital Rangueil, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Aurelien', 'Initials': 'A', 'LastName': 'Amiot', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Université Créteil, Créteil, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Beaugerie', 'Affiliation': ""Department of Gastroenterology, Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ricart', 'Affiliation': 'Gastroenterology Department, Hospital Clínic, Augus Pi i Sunyer Biomedical Research Institute, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dewit', 'Affiliation': ""Service d'Hépato-Gastroentérologie, UCL Saint Luc, Brussels, Belgium.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Sanroman', 'Affiliation': 'Unidad de EII / IBD Unit, Servicio de Gastroenterología y Hepatología, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': ""Peritox UMR I-01, Service d'Hépato-Gastroentérologie, CHU Amiens, Amiens, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Carbonnel', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris Sud 11, Le Kremlin-Bicêtre, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""INSERM U1071, M2iSH, USC-INRA 2018, 3iHP, Service d'Hépato-Gastroentérologie, CHU Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': ""Pôle Maladie Appareil Digestif, Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Colombes, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Service de Gastro-entérologie et Hépatologie, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'van Assche', 'Affiliation': 'Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Terrassa, Spain.'}, {'ForeName': 'Martti', 'Initials': 'M', 'LastName': 'Farkkila', 'Affiliation': 'Clinic of Gastroenterology, Helsinki University Central Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Javier P', 'Initials': 'JP', 'LastName': 'Gisbert', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Marteau', 'Affiliation': 'Service Hépato-gastroentérologie, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Nahon', 'Affiliation': ""Service d'Hépato-gastroentérologie, CHI Le Raincy Montfermeil, Montfermeil, France.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'de Vos', 'Affiliation': 'Gastroenterology unit, Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'INSERM U1256 NGERE, Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Mary', 'Affiliation': 'INSERM UMR-S-1153, Equipe ECSTRA, Hôpital Saint-Louis, Paris Diderot University, Paris, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.001']
2939,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
2940,32780794,A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT).,"BACKGROUND


Despite the rising popularity of plant-based alternative meats, there is limited evidence of the health effects of these products.
OBJECTIVES


We aimed to compare the effect of consuming plant-based alternative meat (Plant) as opposed to animal meat (Animal) on health factors. The primary outcome was fasting serum trimethylamine-N-oxide (TMAO). Secondary outcomes included fasting insulin-like growth factor 1, lipids, glucose, insulin, blood pressure, and weight.
METHODS


SWAP-MEAT (The Study With Appetizing Plantfood-Meat Eating Alternatives Trial) was a single-site, randomized crossover trial with no washout period. Participants received Plant and Animal products, dietary counseling, lab assessments, microbiome assessments (16S), and anthropometric measurements. Participants were instructed to consume ≥2 servings/d of Plant compared with Animal for 8 wk each, while keeping all other foods and beverages as similar as possible between the 2 phases.
RESULTS


The 36 participants who provided complete data for both crossover phases included 67% women, were 69% Caucasian, had a mean ± SD age 50 ± 14 y, and BMI 28 ± 5 kg/m2. Mean ± SD servings per day were not different by intervention sequence: 2.5 ± 0.6 compared with 2.6 ± 0.7 for Plant and Animal, respectively (P = 0.76). Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023). TMAO concentrations were significantly lower for Plant among the n = 18 who received Plant second (2.9 ± 0.4 compared with 6.4 ± 1.5, Plant compared with Animal, P = 0.007), but not for the n = 18 who received Plant first (2.5 ± 0.4 compared with 3.0 ± 0.6, Plant compared with Animal, P = 0.23). Exploratory analyses of the microbiome failed to reveal possible responder compared with nonresponder factors. Mean ± SEM LDL-cholesterol concentrations (109.9 ± 4.5 compared with 120.7 ± 4.5 mg/dL, P = 0.002) and weight (78.7 ± 3.0 compared with 79.6 ± 3.0 kg, P < 0.001) were lower during the Plant phase.
CONCLUSIONS


Among generally healthy adults, contrasting Plant with Animal intake, while keeping all other dietary components similar, the Plant products improved several cardiovascular disease risk factors, including TMAO; there were no adverse effects on risk factors from the Plant products.This trial was registered at clinicaltrials.gov as NCT03718988.",2020,"Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023).","['36 participants who provided complete data for both crossover phases included 67% women, were 69% Caucasian, had a mean\xa0±\xa0SD age 50\xa0±', 'generally healthy adults']","['consuming plant-based alternative meat (Plant', 'Plant and Animal products, dietary counseling, lab assessments, microbiome assessments (16S), and anthropometric measurements', 'SWAP-MEAT ', 'plant-based compared with animal-based meat on trimethylamine-N-oxide']","['fasting insulin-like growth factor 1, lipids, glucose, insulin, blood pressure, and weight', 'Mean\xa0±', 'weight', 'Mean\xa0±\xa0SEM LDL-cholesterol concentrations', 'TMAO concentrations', 'fasting serum trimethylamine-N-oxide (TMAO', 'Mean\xa0±\xa0SEM TMAO concentrations']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0025018', 'cui_str': 'Meat products'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0987864,"Mean ± SEM TMAO concentrations were significantly lower overall for Plant (2.7 ± 0.3) than for Animal (4.7 ± 0.9) (P = 0.012), but a significant order effect was observed (P = 0.023).","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Crimarco', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sparkle', 'Initials': 'S', 'LastName': 'Springfield', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Petlura', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Streaty', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cunanan', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Fielding-Singh', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Carter', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madeline A', 'Initials': 'MA', 'LastName': 'Topf', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Hannah C', 'Initials': 'HC', 'LastName': 'Wastyk', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Erica D', 'Initials': 'ED', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Sonnenburg', 'Affiliation': 'Microbiology and Immunology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa203']
2941,32788120,Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study.,"INTRODUCTION


An individualised thromboprophylaxis was implemented in critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia to reduce mortality and improve clinical outcome. The aim of this study was to evaluate the effect of this intervention on clinical outcome.
METHODS


In this mono-centric, controlled, before-after study, all consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included. A thromboprophylaxis protocol, including augmented LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT, was implemented on March 31th 2020. Primary endpoint is one-month mortality. Secondary outcomes include two-week and three-week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT). Multiple regression modelling was used to correct for differences between the two groups.
RESULTS


46 patients were included in the before group, 26 patients in the after group. One month mortality decreased from 39.13% to 3.85% (p < 0.001). After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)). The cumulative incidence of VTE and CRRT was respectively 41% and 30.4% in the before group and dropped to 15% (p = 0.03) and 3.8% (p = 0.01), respectively. After correction for confounding variables, risk of VTE (p = 0.03, 6.01 (1.13, 32.12)) and CRRT (p = 0.02, OR 19.21 (1.44, 255.86)) remained significantly higher in the before group.
CONCLUSION


Mortality, cumulative risk of VTE and need for CRRT may be significantly reduced in COVID-19 patients by implementation of a more aggressive thromboprophylaxis protocol. Future research should focus on confirmation of these results in a randomized design and on uncovering the mechanisms underlying these observations.
REGISTRATION NUMBER


NCT04394000.",2020,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","['critically ill ICU patients with COVID-19', 'critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia', '46 patients were included in the before group, 26 patients in the after group', 'consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included']","['LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT', 'individualised thromboprophylaxis protocol']","['week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT', 'mortality', 'month mortality', 'cumulative incidence of VTE and CRRT', 'Mortality, cumulative risk of VTE and need for CRRT', 'CRRT']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",46.0,0.053393,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","[{'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Stessel', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium. Electronic address: bjorn.stessel@jessazh.be.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Vanvuchelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'I-BioStat, Data Science Institute, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium.'}, {'ForeName': 'Laurien', 'Initials': 'L', 'LastName': 'Geebelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Vandenbrande', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Pellens', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Van Tornout', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Ory', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Karlijn', 'Initials': 'K', 'LastName': 'van Halem', 'Affiliation': 'Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Messiaen', 'Affiliation': 'UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium; Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Herbots', 'Affiliation': 'Department of Cardiology and Coronary Care Unit, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ramaekers', 'Affiliation': 'Chief Medical Officer, Jessa Hospital, Hasselt, Belgium; Leuven Institute for Healthcare Policy (LIHP), University of Leuven, Belgium.'}, {'ForeName': 'Jasperina', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.038']
2942,32783554,Detection and False-Referral Rates of 2-mSv CT Relative to Standard-Dose CT for Appendiceal Perforation: Pragmatic Multicenter Randomized Controlled Trial.,"OBJECTIVE.  The objective of our study was to compare diagnostic performance of 2-mSv CT and standard-dose CT (SDCT) for the diagnosis of perforated appendicitis in adolescents and young adults.  MATERIALS AND METHODS.  We used the intention-to-treat analysis set of a pragmatic randomized controlled trial involving 3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals. The patients were randomized to undergo either 2-mSv CT or SDCT. Predefined endpoints were sensitivity and specificity. Considering potential verification bias caused by the difference in diagnostic interventions (2-mSv CT vs SDCT), we added endpoints of detection rate (DR) and false-referral rate. The reference standards were surgical or pathologic findings. We used Fisher exact tests. Sensitivity analyses included the following: first, a per-protocol analysis; second, an analysis of a surgical reference standard but not a pathologic reference standard; and, third, an analysis to adjust for site clustering. We tested for heterogeneity in DR and false-referral rate across various patient and hospital characteristics.  RESULTS.  The 2-mSv CT and SDCT groups were comparable regarding DR (5.1% [78/1535] vs 4.9% [76/1539]; 95% CI for the difference, -1.4 to 1.7 percentage points;  p  = 0.87), false-referral rate (3.1% [48/1535] vs 3.1% [47/1539]; 95% CI for the difference, -1.2 to 1.3 percentage points;  p  = 0.92), sensitivity (42.9% [78/182] vs 43.2% [76/176]; 95% CI for the difference, -10.6 to 9.9 percentage points;  p  > 0.99), and specificity (89.2% [305/342] vs 91.2% [354/388]; 95% CI for the difference, -6.4 to 2.3 percentage points;  p  = 0.38). Sensitivity analyses showed similar results. We found no significant subgroup heterogeneity.  CONCLUSION.  The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.",2020,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","['3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals', 'adolescents and young adults']","['2-mSv CT and standard-dose CT (SDCT', 'SDCT', '2-mSv CT or SDCT', '2-mSv CT Relative to Standard-Dose CT']","['diagnostic performance', 'detection rate (DR) and false-referral rate', 'false-referral rate', 'sensitivity', 'specificity', 'sensitivity and specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",3074.0,0.282225,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","[{'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22632']
2943,32794100,Effects of participatory art-based painting workshops in geriatric inpatients: results of a non-randomized open label trial.,"BACKGROUND


Art-based activities like painting workshops demonstrated health benefits in older individuals living in home care facilities. Few studies examined the effects of painting workshops in geriatric inpatients.
AIM


The study aims to examine whether the participation in painting workshops performed in patients admitted to a geriatric acute care ward reduced the number of medications taken daily, use of psychoactive medications, the length of stay and inhospital mortality.
METHODS


Based on a non-randomized open label trial, 79 inpatients who participated in painting workshops and 79 control inpatients were recruited in the geriatric acute care ward of the Jewish general hospital (Montreal, Quebec, Canada). Four outcomes were used: the number of medications taken daily and use of psychoactive medications the day of discharge to geriatric acute care ward, the length of hospital stay and inhospital mortality.
RESULTS


The participation in Painting workshops were associated with a lower number of medications taken daily at discharge (Coefficient of regression β =  - 1.35 with P = 0.001) and lower inhospital mortality (odd ratio (OR) = 0.09 with P = 0.031). No significant association was reported with use of psychoactive medications and length of stay.
CONCLUSION


The participation in painting workshops reduced the number of medications taken daily and incident inhospital mortality in geriatric inpatients admitted to a geriatric acute care ward, suggested a positive effect on health condition of this participatory art-based activity.",2020,"The participation in painting workshops reduced the number of medications taken daily and incident inhospital mortality in geriatric inpatients admitted to a geriatric acute care ward, suggested a positive effect on health condition of this participatory art-based activity.","['geriatric inpatients', '79 inpatients who participated in painting workshops and 79 control inpatients were recruited in the geriatric acute care ward of the Jewish general hospital (Montreal, Quebec, Canada', 'patients admitted to a geriatric acute care ward reduced the number of medications taken daily, use of psychoactive medications, the length of stay and inhospital mortality', 'older individuals living in home care facilities', 'geriatric inpatients admitted to a geriatric acute care']",['participatory art-based painting workshops'],"['number of medications taken daily and use of psychoactive medications the day of discharge to geriatric acute care ward, the length of hospital stay and inhospital mortality', 'psychoactive medications and length of stay', 'number of medications taken daily and incident inhospital mortality', 'inhospital mortality']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0022422', 'cui_str': 'Judaism'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}]",79.0,0.019703,"The participation in painting workshops reduced the number of medications taken daily and incident inhospital mortality in geriatric inpatients admitted to a geriatric acute care ward, suggested a positive effect on health condition of this participatory art-based activity.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Beauchet', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis - Jewish General Hospital, McGill University, 3755 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1E2, Canada. olivier.beauchet@mcgill.ca.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lafleur', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Remondière', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Galery', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vilcocq', 'Affiliation': 'Centre of Excellence on Longevity of McGill Integrated University Health Network, Montreal, QC, Canada.'}, {'ForeName': 'Cyrille P', 'Initials': 'CP', 'LastName': 'Launay', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis - Jewish General Hospital, McGill University, 3755 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1E2, Canada.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01675-0']
2944,32790595,Variations in loop gain and arousal threshold during NREM sleep are affected by time of day over a 24-hour period in participants with obstructive sleep apnea.,"We investigated whether time of day affects loop gain (LG) and the arousal threshold (AT) during non-rapid eye movement (NREM) sleep. Eleven men with obstructive sleep apnea (apnea-hypopnea index > 5 events/h) completed a constant-routine protocol that comprised 3-h sleep sessions in the evening [10 PM (1) to 1 AM], morning (6 AM to 9 AM), afternoon (2 PM to 5 PM), and subsequent evening [10 PM (2) to 1 AM]. During each sleep session LG and the AT were measured during NREM sleep with a model-based approach. Our results showed the presence of a rhythmicity in both LG ( P  < 0.0001) and the AT ( P  < 0.001) over a 24-h period. In addition, LG and the AT were greater in the morning compared with both evening sessions [6 AM vs. 10 PM (1) vs. 10 PM (2): LG (1 cycle/min): 0.71 ± 0.23 vs. 0.60 ± 0.22 ( P  = 0.01) vs. 0.56 ± 0.10 ( P  < 0.001), AT (fraction of eupneic breathing): 1.45 ± 0.47 vs. 1.28 ± 0.36 ( P  = 0.02) vs. 1.20 ± 0.18 ( P  = 0.001)]. No difference in LG and the AT existed between the evening sessions (LG:  P  = 0.27; AT:  P  = 0.24). LG was correlated to measures of the hypocapnic ventilatory response (i.e., a measure of chemoreflex sensitivity) ( r  = 0.72 and  P  = 0.045) and the critical closing pressure (i.e., a measure of airway collapsibility) ( r  = 0.77 and  P  = 0.02) that we previously published. We conclude that time of day, independent of hallmarks of sleep apnea, affects LG and the AT during NREM sleep. These modifications may contribute to increases in breathing instability in the morning compared with other periods throughout the day/night cycle in individuals with obstructive sleep apnea. In addition, efficaciousness of treatments for obstructive sleep apnea that target LG and the AT may be modified by a rhythmicity in these variables. NEW & NOTEWORTHY  Loop gain and the arousal threshold during non-rapid eye movement (NREM) sleep are greater in the morning compared with the afternoon and evening. Loop gain measures are correlated to chemoreflex sensitivity and the critical closing pressure measured during NREM sleep in the evening, morning, and afternoon. Breathing (in)stability and efficaciousness of treatments for obstructive sleep apnea may be modulated by a circadian rhythmicity in loop gain and the arousal threshold.",2020,"Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24).","['participants with obstructive sleep apnea', 'Eleven males with obstructive sleep apnea']",[],"['Loop gain and the arousal threshold', 'breathing instability', 'chemoreflex sensitivity', 'loop gain and the arousal threshold', 'airway collapsibility']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",11.0,0.147017,"Moreover, no difference in loop gain and the arousal threshold existed between 10 PM (1) and 10 PM (2) (Loop gain: p = 0.27; Arousal threshold: p = 0.24).","[{'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Puri', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El-Chami', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shaheen', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Ivers', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Gino S', 'Initials': 'GS', 'LastName': 'Panza', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Ho-Sheng', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Mateika', 'Affiliation': 'John D. Dingell Department of Veterans Affairs Medical Center, Detroit, Michigan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00376.2020']
2945,32778472,"Letter to Editor ""Effects of handwriting exercise on functional outcome in Parkinson disease: A randomized controlled trial"".",,2020,,['Parkinson disease'],['handwriting exercise'],['functional outcome'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.11164,,"[{'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Neuro-Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: priyuarora8427@gmail.com.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Neuro-Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: sharma.nidhi.physio@mmumullana.org.'}, {'ForeName': 'Adarsh Kumar', 'Initials': 'AK', 'LastName': 'Srivastav', 'Affiliation': 'University Research Fellow, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (deemed to be University), Mullana, Ambala, Haryana 133207, India. Electronic address: adarsh.srivastav@mmumullana.org.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.020']
2946,32781086,"Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis.","BACKGROUND & AIMS


Aldafermin, an engineered analog of fibroblast growth factor 19, inhibits bile acid synthesis and regulates metabolic homeostasis. We report results from a 24-week, phase 2 study, with serial liver biopsies, of patients with nonalcoholic steatohepatitis (NASH).
METHODS


We performed a double-blind study of 78 patients with NASH at 9 centers in the United States. Key inclusion criteria were biopsy-proven NASH with Nonalcoholic Fatty Liver Disease Activity Score ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content ≥8%, measured by magnetic resonance imaging-proton density fat fraction. Patients were randomly assigned (1:2) to groups given subcutaneous placebo (n = 25) or aldafermin 1 mg (n = 53) daily for 24 weeks. The primary outcome was change in absolute liver fat content from baseline at week 24. Secondary outcomes included serum markers and histologic measures of fibrosis improvement and NASH resolution.
RESULTS


At week 24, the aldafermin group had a significant reduction in absolute liver fat content (reduction of 7.7%) compared with placebo (reduction of 2.7%; difference, reduction of 5.0%; 95% confidence interval, reduction of 8.0%-1.9%; P = .002). Aldafermin produced significantly greater decreases in levels of 7α-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and neoepitope-specific N-terminal pro-peptide of type III collagen (Pro-C3) than placebo. Fibrosis improvement (≥1 stage) with no worsening of NASH was achieved in 38% of patients receiving aldafermin vs 18% of patients receiving placebo (P = .10). NASH resolution with no worsening of fibrosis was observed in 24% of patients given aldafermin vs 9% of patients given placebo (P = .20). Discontinuations due to adverse events occurred in no patients in the aldafermin group and 4% of patients in the placebo group.
CONCLUSIONS


In a phase 2 trial of patients with NASH, aldafermin reduced liver fat and produced a trend toward fibrosis improvement. ClinicalTrials.gov, Number: NCT02443116.",2020,"Aldafermin produced significantly greater decreases in levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3 than placebo.","['78 patients with NASH at 9 centers in the United States', 'patients with non-alcoholic steatohepatitis (NASH', 'Key inclusion criteria were biopsy-proven NASH with non-alcoholic fatty liver disease activity score (NAS) ≥4, stage 2 or 3 fibrosis by NASH Clinical Research Network classification, and absolute liver fat content (LFC', 'Patients With Nonalcoholic Steatohepatitis']","['aldafermin', 'Placebo', 'Aldafermin', 'subcutaneous placebo', 'placebo']","['Discontinuations due to adverse events', 'levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3', 'change in absolute LFC', 'NASH resolution with no worsening of fibrosis', 'absolute LFC', 'serum markers and histological measures of fibrosis improvement and NASH resolution', 'Fibrosis improvement (≥1 stage) with no worsening of NASH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0049730', 'cui_str': '7 alpha-hydroxy-4-cholesten-3-one'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",78.0,0.570415,"Aldafermin produced significantly greater decreases in levels of 7alpha-hydroxy-4-cholesten-3-one, bile acids, alanine and aspartate aminotransferases, and Pro-C3 than placebo.","[{'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Radcliffe Department of Medicine, University of Oxford, United Kingdom; Pinnacle Clinical Research, San Antonio, Texas. Electronic address: stephenharrison87@gmail.com.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Neff', 'Affiliation': 'Covenant Research, Sarasota, Florida.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Guy', 'Affiliation': 'Pathology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Mustafa R', 'Initials': 'MR', 'LastName': 'Bashir', 'Affiliation': 'Radiology and Medicine (Gastroenterology), Duke University, Durham, North Carolina.'}, {'ForeName': 'Angelo H', 'Initials': 'AH', 'LastName': 'Paredes', 'Affiliation': 'San Antonio Military Medical Center, San Antonio, Texas.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Younes', 'Affiliation': 'Gastro One Research, Germantown, Tennessee.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Trotter', 'Affiliation': 'Clinical Research and Education, Texas Digestive Disease Consultants, Dallas, Texas.'}, {'ForeName': 'Nadege T', 'Initials': 'NT', 'LastName': 'Gunn', 'Affiliation': 'Pinnacle Clinical Research, Austin, Texas.'}, {'ForeName': 'Sam E', 'Initials': 'SE', 'LastName': 'Moussa', 'Affiliation': 'Adobe Clinical Research, Tucson, Arizona.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Arizona Liver Health, Chandler, Arizona.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Nelson', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Gottwald', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California.'}, {'ForeName': 'William C G', 'Initials': 'WCG', 'LastName': 'Chang', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California.'}, {'ForeName': 'Andrew Z', 'Initials': 'AZ', 'LastName': 'Yan', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California. Electronic address: lling@ngmbio.com.'}, {'ForeName': 'Hsiao D', 'Initials': 'HD', 'LastName': 'Lieu', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, California.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.004']
2947,32784188,Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial.,"BACKGROUND


Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adolescents is common and disabling. Teenagers in the United Kingdom are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment.
OBJECTIVE


This study aims to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial).
METHODS


This study is an internal pilot for the initial 12 months of a full randomized controlled trial (RCT), with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Recruitment and treatment were delivered remotely from a specialist pediatric CFS/ME treatment service within a hospital in South West United Kingdom. Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center. Eligibility assessment and recruitment were conducted via remote methods (telephone and on the web), and participants were randomized (via a computer-automated system) to 1 of 2 web-based treatments. The trial intervention was Fatigue in Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform). The comparator was Skype-delivered activity management with a CFS/ME clinician (mainly a physiotherapist or occupational therapist). Both treatments were intended to last for up to 6 months. The primary outcomes were (1) the number of participants recruited (per out-of-area referrals received between November 1, 2016, to October 31, 2017) and the proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments.
RESULTS


A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data. Overall, web-based treatment was acceptable; however, participants and clinicians described both the advantages and disadvantages of remote methods. No serious adverse events were reported.
CONCLUSIONS


Recruiting young people (and their parents or caregivers) into an RCT of web-based treatment via remote methods is feasible and acceptable. Delivering specialist treatment at home via the internet is feasible and acceptable, although some families prefer to travel across the United Kingdom for face-to-face treatment.
TRIAL REGISTRATION


ISRCTN 18020851; http://www.isrctn.com/ISRCTN18020851.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s13063-018-2500-3.",2020,"No serious adverse events were reported.
","['adolescents with CFS/ME and (2', 'A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data', 'Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center', 'Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform']",['internet-delivered specialist treatment'],"['proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments', 'serious adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332285', 'cui_str': 'In'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.161872,"No serious adverse events were reported.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Anderson', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Parslow', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Macleod', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pywell', 'Affiliation': 'Advanced Computing Research Centre, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Kieren', 'Initials': 'K', 'LastName': 'Pitts', 'Affiliation': 'Research IT, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Price', 'Affiliation': 'Department of Computer Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stallard', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centres, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Van de Putte', 'Affiliation': ""Department of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Nijhof', 'Affiliation': ""Department of Paediatrics, Wilhelmina Children's Hospital, University Medical Centre Utrecht, Utrecht, Netherlands.""}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Bleijenberg', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Crawley', 'Affiliation': 'Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}]",Journal of medical Internet research,['10.2196/17768']
2948,32798050,Impact of different front-of-pack nutrition labels on online food choices.,"Front-of-pack nutrition labels (FOP-NL) are efficient tools for increasing consumers' awareness of the nutritional quality of food products, prompting healthier food choices. The main goal of this study was to evaluate the impact of four FOP-NL schemes - Traffic Light label (TL), Guideline Daily Amounts (%GDA), Nutri-Score (NS) and Health Star Rating (HSR) - on consumers' selection of food products according to perceived nutritional quality. A cross-sectional open-label crossover randomized controlled study was carried out among Portuguese consumers. A web-based questionnaire was used to assess participants' a) preferences regarding FOP-NLs and b) capacity to select healthy products in a food selection task using the information from FOP-NL schemes. When performing the selection task, participants had the option to indicate that they could not decide simply based on the presented FOP-NL (requiring more information). Overall, 357 adults participated in the study. Regarding consumers' preferences, TL received the most favorable responses, while NS received the fewest. All FOP-NLs performed better than the no-nutritional label control condition in the food selection task. The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs. Percentages of respondents indicating not being able to answer due to lack of information affected the proportion of correct choices, with 10.3% for TL, 12.9% for %GDA, 14.6% for HSR, and 25.8% for NS, indicating they were unable to choose without additional information. Although no particular FOP-NL system stood out as the most significantly effective, TL was the most preferred by Portuguese adults. Long-term real-world evidence is necessary to assess the impact of FOP-NL systems on individuals' food choices.",2020,"The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs.","['357 adults participated in the study', 'Portuguese consumers']","['Front-of-pack nutrition labels (FOP-NL', 'FOP-NL schemes - Traffic Light label (TL), Guideline Daily Amounts (%GDA', 'different front-of-pack nutrition labels']","['highest proportion of correct choices', 'Nutri-Score (NS) and Health Star Rating (HSR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0016037', 'cui_str': 'Progressive myositis ossificans'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0523683', 'cui_str': 'Guanine deaminase measurement'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0018757', 'cui_str': 'Research, Health Services'}]",357.0,0.0356447,"The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs.","[{'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Santos', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Unbreakable Idea Research, Lda, Painho, Portugal. Electronic address: osantos@medicina.ulisboa.pt.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Alarcão', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Centro de Investigação e Estudos de Sociologia (CIES-IUL), Instituto Universitário de Lisboa (ISCTE-IUL), Lisboa, Portugal. Electronic address: valarcao@medicina.ulisboa.pt.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Feteira-Santos', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: rodrigosantos@medicina.ulisboa.pt.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Fernandes', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: joao@campus.ul.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Virgolino', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: avirgolino@medicina.ulisboa.pt.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Sena', 'Affiliation': 'Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal.'}, {'ForeName': 'Carlota Pacheco', 'Initials': 'CP', 'LastName': 'Vieira', 'Affiliation': 'Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal.'}, {'ForeName': 'Maria João', 'Initials': 'MJ', 'LastName': 'Gregório', 'Affiliation': 'Programa Nacional para a Promoção da Alimentação Saudável, Direção-Geral da Saúde, Lisboa, Portugal, Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto. Rua do Campo Alegre, 823, 4150-180, Porto, Portugal. Electronic address: mariajoaobg@dgs.min-saude.pt.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Nogueira', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Laboratório de Biomatemática, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: pnogueira@medicina.ulisboa.pt.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Graça', 'Affiliation': 'Programa Nacional para a Promoção da Alimentação Saudável, Direção-Geral da Saúde, Lisboa, Portugal, Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto. Rua do Campo Alegre, 823, 4150-180, Porto, Portugal. Electronic address: pedrograca@fcna.up.pt.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Escola Superior de Enfermagem de Lisboa, Lisboa, Portugal, Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: andreiajsilvadacosta@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104795']
2949,32777692,Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.,"OBJECTIVE


To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.
METHODS


We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.
RESULTS


We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.
CONCLUSION


Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.",2020,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","['persons with opioid use disorder seeking treatment', 'persons with opioid use disorder (OUD', 'participants who reported HRQoL beyond baseline']","['naltrexone or buprenorphine-naloxone', 'opioid use disorder pharmacotherapy']",['health-related quality-of-life (HRQoL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",508.0,0.0789426,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. Electronic address: alj4004@med.cornell.edu.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108221']
2950,32789625,"Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.","Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be ""very"" or ""completely"" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.",2020,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","['adolescent sexual minority males', 'Adolescent Sexual Minority Males']",['mobile behavioral HIV prevention intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544438,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Gordián-Arroyo', 'Affiliation': 'Columbia University, Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Keck School of Medicine of the University of Southern California/Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schrimshaw', 'Affiliation': 'University of Central Florida, College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University, School of Nursing, New York, NY, USA. rb897@columbia.edu.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-020-00447-5']
2951,32786188,Compression Therapy to Prevent Recurrent Cellulitis of the Leg.,"BACKGROUND


Chronic edema of the leg is a risk factor for cellulitis. Daily use of compression garments on the leg has been recommended to prevent the recurrence of cellulitis, but there is limited evidence from trials regarding its effectiveness.
METHODS


In this single-center, randomized, nonblinded trial, we assigned participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group). Follow-up occurred every 6 months for up to 3 years or until 45 episodes of cellulitis had occurred in the trial. The primary outcome was the recurrence of cellulitis. Participants in the control group who had an episode of cellulitis crossed over to the compression group. Secondary outcomes included cellulitis-related hospital admission and quality-of-life assessments.
RESULTS


A total of 183 patients were screened, and 84 were enrolled; 41 participants were assigned to the compression group, and 43 to the control group. At the time of a planned interim analysis, when 23 episodes of cellulitis had occurred, 6 participants (15%) in the compression group and 17 (40%) in the control group had had an episode of cellulitis (hazard ratio, 0.23; 95% confidence interval [CI], 0.09 to 0.59; P = 0.002; relative risk [post hoc analysis], 0.37; 95% CI, 0.16 to 0.84; P = 0.02), and the trial was stopped for efficacy. A total of 3 participants (7%) in the compression group and 6 (14%) in the control group were hospitalized for cellulitis (hazard ratio, 0.38; 95% CI, 0.09 to 1.59). Most quality-of-life outcomes did not differ between the two groups. No adverse events occurred during the trial.
CONCLUSIONS


In this small, single-center, nonblinded trial involving patients with chronic edema of the leg and cellulitis, compression therapy resulted in a lower incidence of recurrence of cellulitis than conservative treatment. (Funded by Calvary Public Hospital Bruce; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000412336.).",2020,Most quality-of-life outcomes did not differ between the two groups.,"['Participants in the control group who had an episode of cellulitis crossed over to the compression group', 'A total of 183 patients were screened, and 84 were enrolled; 41 participants', 'participants with chronic edema of the leg and recurrent cellulitis, in a 1:1 ratio, to receive', 'patients with chronic edema of the leg and cellulitis']","['leg compression therapy plus education on cellulitis prevention (compression group) or education alone (control group', 'compression therapy', 'Compression Therapy', 'compression garments']","['cellulitis-related hospital admission and quality-of-life assessments', 'Most quality-of-life outcomes', 'adverse events', 'hospitalized for cellulitis', 'recurrence of cellulitis', 'episode of cellulitis']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0333241', 'cui_str': 'Chronic edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0742020', 'cui_str': 'Recurrent cellulitis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",183.0,0.162501,Most quality-of-life outcomes did not differ between the two groups.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Webb', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Neeman', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Bowden', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Gaida', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Mumford', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Bissett', 'Affiliation': 'From the Physiotherapy Department, Calvary Public Hospital Bruce, Bruce, ACT (E.W.), the Biological Data Science Institute, the Australian National University Joint Colleges of Science, Health, and Medicine (T.N.), and the Medical School (F.J.B.), Australian National University, the University of Canberra Research Institute for Sport and Exercise (J.G.), and the Discipline of Physiotherapy, Faculty of Health, University of Canberra (E.W., B.B.), Canberra, ACT, and the Australian Institute of Health Innovation, Macquarie University, Sydney (V.M.) - all in Australia.'}]",The New England journal of medicine,['10.1056/NEJMoa1917197']
2952,32773375,"Communicating Uncertainty in Written Consumer Health Information to the Public: Parallel-Group, Web-Based Randomized Controlled Trial.","BACKGROUND


Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers.
OBJECTIVE


The aim of this study was to examine the impact of different uncertainty descriptions regarding the evidence for a treatment effect in a written research summary for the public.
METHODS


We developed 8 versions of a research summary on a fictitious drug for tinnitus with varying degrees (Q1), sources (Q2), and magnitudes of uncertainty (Q3). We recruited 2099 members of the German public from a web-based research panel. Of these, 1727 fulfilled the inclusion criteria and were randomly presented with one of these research summaries. Randomization was conducted by using a centralized computer with a random number generator. Web-based recruitment and data collection were fully automated. Participants were not aware of the purpose of the study and alternative presentations. We measured the following outcomes: perception of the treatment effectiveness (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence, text quality, and intended decision. The outcomes were self-assessed.
RESULTS


For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048). Pairwise comparisons showed a weaker perception of treatment effectiveness for the research summary with 3 sources of uncertainty compared to the version with 2 sources of uncertainty (P=.04). Specifically, the proportion of the participants in the group with 3 sources of uncertainty that perceived the drug as possibly beneficial was 9% lower than that of the participants in the group with 2 sources of uncertainty (92/195, 47.2% vs 111/197, 56.3%, respectively). The proportion of the participants in the group with 3 sources of uncertainty that considered the drug to be of unclear benefit was 8% higher than that of the participants in the group with 2 sources of uncertainty (72/195, 36.9% vs 57/197, 28.9%, respectively). However, there was no significant difference compared to the version with 1 source of uncertainty (P=.31). We did not find any meaningful differences between the research summaries for the secondary outcomes.
CONCLUSIONS


Communicating even a large magnitude of uncertainty for a treatment effect had little impact on the perceived effectiveness. Efforts to improve public understanding of research are needed to improve the understanding of evidence-based health information.
TRIAL REGISTRATION


German Clinical Trials Register DRKS00015911, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015911.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/13425.",2020,"For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048).","['We recruited 2099 members of the German public from a web-based research panel', '1727 fulfilled the inclusion criteria and were randomly presented with one of these research summaries']",[],"['tinnitus with varying degrees (Q1), sources (Q2), and magnitudes of uncertainty (Q3', 'global effect for Q3', 'global effect for Q1 and Q2']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",[],"[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.132533,"For the primary outcome, we did not find a global effect for Q1 and Q2 (P=.25 and P=.73), but we found a global effect for Q3 (P=.048).","[{'ForeName': 'Roland B', 'Initials': 'RB', 'LastName': 'Büchter', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Betsch', 'Affiliation': 'Media and Communication Science, University of Erfurt, Erfurt, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Ehrlich', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Fechtelpeter', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Grouven', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Meuer', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}, {'ForeName': 'Constanze', 'Initials': 'C', 'LastName': 'Rossmann', 'Affiliation': 'Media and Communication Science, University of Erfurt, Erfurt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Waltering', 'Affiliation': 'Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.'}]",Journal of medical Internet research,['10.2196/15899']
2953,32773377,#BlackBreastsMatter: Process Evaluation of Recruitment and Engagement of Pregnant African American Women for a Social Media Intervention Study to Increase Breastfeeding.,"BACKGROUND


In the United States, there are lower rates of breastfeeding among African American mothers, particularly those who are younger women. Recent epidemiological studies have shown a strong association of more aggressive types of breast cancer (estrogen receptor negative) among African American women, with a higher risk in African American women who did not breastfeed their children.
OBJECTIVE


This study aims to describe the process evaluation of recruitment and educational strategies to engage pregnant African American participants for a pilot study designed to determine whether social media messaging about breast cancer risk reduction through breastfeeding may positively influence breastfeeding rates.
METHODS


This pilot study is conducted in collaboration with a local Women, Infants, and Children (WIC) organization and hospital and prenatal clinics of a local health care network. To engage African American women to enroll in the study, several methods and monitoring processes were explored, including WIC electronic text-based messages sent out to all phones of current WIC recipients (referred to as e-blasts); keyword responses to texts from flyers and posters in local community-based organizations, hospitals, and prenatal clinics; keyword responses using electronic links posted in established Facebook groups; and snowball recruitment of other pregnant women by current participants through Facebook. Once enrolled, participants were randomized to 2 study conditions: (1) an intervention group receiving messages about breast cancer risk reduction and breastfeeding or (2) a control group receiving breastfeeding-only messages. Data were obtained through electronic monitoring, SurveyMonkey, qualitative responses on Facebook, focus groups, and interviews.
RESULTS


More than 3000 text messages were sent and received through WIC e-blasts and keyword responses from flyers. A total of 472 women were recruited through WIC e-blast, and 161 responded to flyers and contacts through the local health care network, community-based organizations, Facebook, and friend referrals. A total of 633 women were assessed for eligibility to participate in the study. A total of 288 pregnant African American women were enrolled, consented, and completed presurvey assessments (102.8% of the goal), and 22 participants attended focus groups or interviews reporting on their experiences with Facebook and the educational messages.
CONCLUSIONS


This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women. Providing messaging and resources through social media to reinforce and educate women about breastfeeding and potentially provide lactation support is intriguing. Convenience (for researchers and participants) is an attribute of social media for this demographic of women and worthy of further research as an educational tool.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03680235; https://clinicaltrials.gov/ct2/show/NCT03680235.",2020,"This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women.","['A total of 633 women were assessed for eligibility to participate in the study', '288 pregnant African American women were enrolled, consented, and completed presurvey assessments (102.8% of the goal), and 22 participants attended focus groups or interviews reporting on their experiences with', 'African American mothers, particularly those who are younger women', 'pregnant African American women', 'Pregnant African American Women', 'African American women, with a higher risk in African American women who did not breastfeed their children', 'collaboration with a local Women, Infants, and Children (WIC) organization and hospital and prenatal clinics of a local health care network', 'A total of 472 women were recruited through WIC e-blast, and 161 responded to flyers and contacts through the local health care network, community-based organizations, Facebook, and friend referrals', 'engage pregnant African American participants']","['Facebook and the educational messages', 'social media messaging', 'BlackBreastsMatter', 'intervention group receiving messages about breast cancer risk reduction and breastfeeding or (2) a control group receiving breastfeeding-only messages']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],472.0,0.0689026,"This process evaluation suggests that using electronic, smartphone apps with social media holds promise for both recruitment and conduct of health education intervention studies for pregnant African American women.","[{'ForeName': 'Cassy', 'Initials': 'C', 'LastName': 'Dauphin', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Nikia', 'Initials': 'N', 'LastName': 'Clark', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Cadzow', 'Affiliation': ""Department of Health Services Administration, D'Youville College, Buffalo, NY, United States.""}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Saad-Harfouche', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Rodriguez', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Glaser', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kiviniemi', 'Affiliation': 'Department of Health, Behavior and Society, University of Kentucky, Lexington, KY, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Keller', 'Affiliation': 'Department of Community Health and Health Behavior, State University of New York at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Erwin', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.'}]",Journal of medical Internet research,['10.2196/16239']
2954,32805184,Effects of Fatty Acid Therapy in Addition to Strong Statin on Coronary Plaques in Acute Coronary Syndrome: An Optical Coherence Tomography Study.,"BACKGROUND Vascular healing response associated with adjunctive n-3 polyunsaturated fatty acid therapy therapy in patients receiving strong statin therapy remains unclear. The aim of this study was to evaluate the effect of polyunsaturated fatty acid therapy with eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) in addition to strong statin therapy on coronary atherosclerotic plaques using optical coherence tomography. METHODS AND RESULTS This prospective multicenter randomized controlled trial included 130 patients with acute coronary syndrome treated with strong statins. They were assigned to either statin only (control group, n=42), statin+high-dose EPA (1800 mg/day) (EPA group, n=40), statin+EPA (930 mg/day)+DHA (750 mg/day) (EPA+DHA group, n=48). Optical coherence tomography was performed at baseline and at the 8-month follow-up. The target for optical coherence tomography analysis was a nonculprit lesion with a lipid plaque. Between baseline and the 8-month follow-up, fibrous cap thickness (FCT) significantly increased in all 3 groups. There were no significant differences in the percent change for minimum FCT between the EPA or EPA+DHA group and the control group. In patients with FCT <120 µm (median value), the percent change for minimum FCT was significantly higher in the EPA or EPA+DHA group compared with the control group. CONCLUSIONS EPA or EPA+DHA therapy in addition to strong statin therapy did not significantly increase FCT in nonculprit plaques compared with strong statin therapy alone, but significantly increased FCT in patients with thinner FCT. Registration URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN 000012825.",2020,"Between baseline and the 8-month follow-up, fibrous cap thickness (FCT) significantly increased in all 3 groups.","['patients with thinner FCT', 'Acute Coronary Syndrome', '130 patients with acute coronary syndrome treated with strong statins', 'patients receiving strong statin therapy remains unclear']","['Fatty Acid Therapy', 'polyunsaturated fatty acid therapy with eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA', 'statin+EPA (930\xa0mg/day)+DHA', 'adjunctive n-3 polyunsaturated fatty acid therapy therapy', 'statin+high-dose EPA', 'statin']","['coronary atherosclerotic plaques', 'fibrous cap thickness (FCT', 'FCT', 'minimum FCT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",130.0,0.076865,"Between baseline and the 8-month follow-up, fibrous cap thickness (FCT) significantly increased in all 3 groups.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kita', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kamon', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Tsunenari', 'Initials': 'T', 'LastName': 'Soeda', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Okayama', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishigami', 'Affiliation': 'Department of Cardiology Saiseikai Suita Hospital Suita Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Department of Cardiovascular Medicine Nara Prefecture General Medical Center Nara Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Horii', 'Affiliation': 'Department of Cardiovascular Medicine Nara City Hospital Nara Japan.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Inoue', 'Affiliation': 'Yamato Kashihara Hospital Kashihara Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiology Nara Prefecture Seiwa Medical Center Nara Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okura', 'Affiliation': 'Department of Cardiology Gifu University Gradual School of Medicine Gifu Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Uemura', 'Affiliation': 'Division of CardiologyKawasaki Medical School Kurashiki Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015593']
2955,32805185,Effect of Luseogliflozin on Heart Failure With Preserved Ejection Fraction in Patients With Diabetes Mellitus.,"Background Effects of sodium-glucose cotransporter 2 inhibitors on reducing hospitalization for heart failure have been reported in randomized controlled trials, but their effects on patients with heart failure with preserved ejection fraction (HFpEF) are unknown. This study aimed to evaluate the drug efficacy of luseogliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with type 2 diabetes mellitus and HFpEF. Methods and Results We performed a multicenter, open-label, randomized, controlled trial for comparing luseogliflozin 2.5 mg once daily with voglibose 0.2 mg 3 times daily in patients with type 2 diabetes mellitus suffering from HFpEF (left ventricular ejection fraction >45% and BNP [B-type natriuretic peptide] concentrations ≥35 pg/mL) in a 1:1 randomization fashion. The primary outcome was the difference from baseline in BNP levels after 12 weeks of treatment between the 2 drugs. A total of 173 patients with diabetes mellitus and HFpEF were included. Of these, 83 patients were assigned to receive luseogliflozin and 82 to receive voglibose. There was no significant difference in the reduction in BNP concentrations after 12 weeks from baseline between the 2 groups. The ratio of the mean BNP value at week 12 to the baseline value was 0.79 in the luseogliflozin group and 0.87 in the voglibose group (percent change, -9.0% versus -1.9%; ratio of change with luseogliflozin versus voglibose, 0.93; 95% CI, 0.78-1.10;  P =0.26). Conclusion In patients with type 2 diabetes mellitus and HFpEF, there is no significant difference in the degree of reduction in BNP concentrations after 12 weeks between luseogliflozin and voglibose. Registration URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000018395.",2020,"The ratio of the mean BNP value at week 12 to the baseline value was 0.79 in the luseogliflozin group and 0.87 in the voglibose group (percent change, -9.0% versus -1.9%; ratio of change with luseogliflozin versus voglibose, 0.93; 95% CI, 0.78-1.10;  P =0.26).","['patients with heart failure with preserved ejection fraction (HFpEF', 'patients with type 2 diabetes mellitus suffering from HFpEF', '83 patients', 'Patients With Diabetes Mellitus', 'patients with type 2 diabetes mellitus and HFpEF', '173 patients with diabetes mellitus and HFpEF were included']","['Luseogliflozin', 'sodium-glucose cotransporter 2 inhibitors', 'luseogliflozin', 'luseogliflozin and 82 to receive voglibose', 'luseogliflozin, a sodium-glucose cotransporter 2 inhibitor', 'BNP [B-type natriuretic peptide', 'luseogliflozin 2.5\xa0mg once daily with voglibose 0.2\xa0mg 3 times daily']","['Heart Failure With Preserved Ejection Fraction', 'ratio of the mean BNP value', 'BNP concentrations', 'BNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0532578', 'cui_str': 'voglibose'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",173.0,0.100141,"The ratio of the mean BNP value at week 12 to the baseline value was 0.79 in the luseogliflozin group and 0.87 in the voglibose group (percent change, -9.0% versus -1.9%; ratio of change with luseogliflozin versus voglibose, 0.93; 95% CI, 0.78-1.10;  P =0.26).","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ejiri', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Internal Medicine Tamano City Hospital Okayama Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kihara', 'Affiliation': 'Department of Internal Medicine Kihara Cardiovascular Clinic Asahikawa Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Hata', 'Affiliation': 'Department of Cardiology Minamino Cardiovascular Hospital Hachioji Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Department of Internal Medicine Iwasa Hospital Gifu Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takaishi', 'Affiliation': 'Department of Cardiology Mitoyo General Hospital Kanonji Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Nanba', 'Affiliation': 'Department of Cardiology Okayama Rosai Hospital Okayama Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine Specified Clinic of Soyokaze Cardiovascular Medicine and Diabetes Care Matsuyama Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Akagi', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sakuragi', 'Affiliation': 'Department of Cardiovascular Medicine Iwakuni Clinical Center Iwakuni Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Minagawa', 'Affiliation': 'Department of Internal Medicine Minagawa Cardiovascular Clinic Gifu Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Department of Cardiovascular Medicine Okayama City Hospital Okayama Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nishii', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Fuke', 'Affiliation': 'Department of Cardiovascular Medicine Japanese Red Cross Okayama Hospital Okayama Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Cardiology Fukuyama City Hospital Fukuyama Japan.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.015103']
2956,32780999,"Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia.","BACKGROUND


Despite expectant management, preeclampsia remote from term usually results in preterm delivery. Antithrombin, which displays antiinflammatory and anticoagulant properties, may have a therapeutic role in treating preterm preeclampsia, a disorder characterized by endothelial dysfunction, inflammation, and activation of the coagulation system.
OBJECTIVE


This randomized, placebo-controlled clinical trial aimed to evaluate whether intravenous recombinant human antithrombin could prolong gestation and therefore improve maternal and fetal outcomes.
STUDY DESIGN


We performed a double-blind, placebo-controlled trial at 23 hospitals. Women were eligible if they had a singleton pregnancy, early-onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks' gestation, and planned expectant management. In addition to standard therapy, patients were randomized to receive either recombinant human antithrombin 250 mg loading dose followed by a continuous infusion of 2000 mg per 24 hours or an identical saline infusion until delivery. The primary outcome was days gained from randomization until delivery. The secondary outcome was composite neonatal morbidity score. A total of 120 women were randomized.
RESULTS


There was no difference in median gestational age at enrollment (27.3 weeks' gestation for the recombinant human antithrombin group [range, 23.1-30.0] and 27.6 weeks' gestation for the placebo group [range, 23.0-30.0]; P=.67). There were no differences in median increase in days gained (5.0 in the recombinant human antithrombin group [range, 0-75] and 6.0 for the placebo group [range, 0-85]; P=.95). There were no differences between groups in composite neonatal morbidity scores or in maternal complications. No safety issues related to recombinant human antithrombin were noted in this study, despite the achievement of supraphysiological antithrombin concentrations.
CONCLUSION


The administration of recombinant human antithrombin in preterm preeclampsia neither prolonged pregnancy nor improved neonatal or maternal outcomes.",2020,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"['120 women were randomized', 'Preterm Preeclampsia (PRESERVE-1', '23 hospitals', 'Women were eligible if they had a singleton pregnancy, early onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks, and expectant management was planned']","['Placebo', 'Antithrombin', 'recombinant antithrombin', 'Recombinant Antithrombin Versus Placebo', 'placebo']","['composite neonatal morbidity score', 'median gestational age', 'composite neonatal morbidity scores', 'neonatal or maternal outcomes', 'days gained from randomization until delivery', 'median increase in days gained']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",120.0,0.711927,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Paidas', 'Affiliation': 'Yale University School of Medicine, New Haven, CT. Electronic address: mxp1440@med.miami.edu.'}, {'ForeName': 'Allan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Ehrenkranz', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Triche', 'Affiliation': 'Brown University School of Medicine, Providence, RI.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Streisand', 'Affiliation': 'rEVO Biologics and LFB USA, Inc, Framingham, MA.'}, {'ForeName': 'Garrett K', 'Initials': 'GK', 'LastName': 'Lam', 'Affiliation': 'University of Tennessee College of Medicine, Memphis, TN.'}, {'ForeName': 'Everett F', 'Initials': 'EF', 'LastName': 'Magann', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ""University of South Alabama Children's and Women's Hospital, Mobile, AL.""}, {'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Dombrowski', 'Affiliation': 'St. John Hospital and Medical Center, Detroit, MI.'}, {'ForeName': 'Erika F', 'Initials': 'EF', 'LastName': 'Werner', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': 'University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Mounira A', 'Initials': 'MA', 'LastName': 'Habli', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Grotegut', 'Affiliation': 'Duke University Health System, NC.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'The University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Longo', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Amon', 'Affiliation': 'St. Louis University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Cleary', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'How', 'Affiliation': 'Norton Healthcare, Louisville, KY.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Novotny', 'Affiliation': 'University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Whiteman', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Wing', 'Affiliation': 'University of California Irvine, Irvine, CA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Scifres', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'University of Texas Health Sciences Center at Houston, Houston, TX.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.004']
2957,32788150,"Smartphone-Enhanced Symptom Management In Psychosis: Open, Randomized Controlled Trial.","BACKGROUND


Improving recovery from acute symptoms and preventing relapse are two significant challenges in severe mental illness. We developed a personalized smartphone-based app to monitor symptoms in real time and validated its acceptance, reliability, and validity.
OBJECTIVE


To assess (i) acceptability of continuous monitoring to SMI patients and health professionals over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; and (iii) the feasibility of detecting early warning signs of relapse.
METHODS


The active symptom monitoring smartphone app was built into an end-to-end system in two NHS Trusts to enable real-time symptom self-monitoring and detection by the clinical team of early signs of relapse in people with severe mental illness. We conducted an open randomized controlled trial of active symptom monitoring compared to usual management to assess: (i) acceptability and safety of continuous monitoring over 3 months; (ii) impact of active self-monitoring on positive psychotic symptoms assessed at 6 and 12 weeks; (iii) feasibility of detecting early warning signs of relapse communicated to the healthcare staff via an app streaming data to the electronic health record. Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team.
RESULTS


Of 181 eligible patients, 81 (45%) consented and were randomized to either active symptom monitoring or management as usual. At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks. The pre-planned intent-to-treat analysis of the primary outcome, a positive score on the Positive and Negative Syndrome Scale (PANSS) scale, showed a significant reduction in the active symptom monitoring group over 12 weeks in the early intervention center. Alerts for personalized early warning signs of relapse were built into the workflows of both NHS Trusts, and 100% of health professional staff used the system in a new digital workflow. Qualitative analyses supported the acceptability of the system to participants and staff.
CONCLUSIONS


The active smartphone monitoring system is feasible and was accepted by users in a 3-month study of people with severe mental illness, with surprisingly high levels of adherence. App use was associated with psychotic symptom improvement in recent-onset participants, but not those with longstanding illness, supporting the notion of improved self-management. When built into clinical management workflows to enable personalized alerts of symptom deterioration, the app has demonstrated utility in promoting earlier intervention for relapse.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN88145142; http://www.isrctn.com/ISRCTN88145142.",2020,"At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks.","['people with severe mental illness', '181 eligible patients, 81 (45%) consented', 'Eligible participants with a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of schizophrenia and related disorders, and a history of relapse within the previous two years were enrolled from an early intervention team and a community mental health team']","['active self-monitoring', 'continuous monitoring over 3 months; (ii) impact of active self-monitoring', 'Smartphone-Enhanced Symptom Management', 'active symptom monitoring']","['adherence rate', 'positive psychotic symptoms', 'psychotic symptom improvement', 'empowerment scale', 'positive score on the Positive and Negative Syndrome Scale (PANSS) scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}]",181.0,0.117585,"At 12 weeks, 90% (33/36) of those in the active monitoring group continued to use the system and exhibited an adherence rate (defined as responding to >33% of alerts) of 84% (30/36}. Active symptom monitoring was associated with no difference on the empowerment scale in comparison to the usual management group at 12 weeks.","[{'ForeName': 'Shon', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ainsworth', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sanders', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Stockton-Powdrell', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Machin', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Whelan', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hopkins', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Applegate', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Drake', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Bamford', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Manchester Academic Health Sciences Centre, Greater Manchester Mental Health Foundation Trust, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Institute of Psychiatry, Psychology and Neurosciences, King's College London, London, United Kingdom.""}]",Journal of medical Internet research,['10.2196/17019']
2958,32790904,Vortioxetine versus other antidepressants in the treatment of burning mouth syndrome: An open-label randomized trial.,"OBJECTIVES


This randomized open-label trial compared the efficacy and tolerability of vortioxetine (15 mg/daily) with different antidepressants in the treatment of patients with burning mouth syndrome (BMS).
METHODS


One and hundred fifty BMS patients were randomized into five groups and treated with either vortioxetine, paroxetine (20 mg/daily), sertraline (50 mg/daily), escitalopram (10 mg/daily) or duloxetine (60 mg/daily). The Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E) were performed at baseline and after 2, 4, 6, and 12 months of treatment. Any adverse events (AEs) were tabulated for each group. Descriptive statistics, including the Kruskal-Wallis non-parametric test and the Friedman non-parametric test for median comparisons between different times, were used.
RESULTS


All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI-I, and CGI-E scores in the long-term (p < .001). However, the response rate of the vortioxetine group showed a significant reduction after six months. The medians, after 6 months, were as follows: VAS 0.0; T-PRI 2.0; HAM-A 7.0; HAM-D 7.0; CGI-I 1.0; and CGI-E 1.0 with a lower incidence of AEs (p < .019).
CONCLUSION


Vortioxetine was efficacious with a shorter latency of action and fewer AEs compared with other ADs.",2020,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","['patients with Burning Mouth Syndrome (BMS', '150 BMS patients', 'Burning Mouth Syndrome']","['vortioxetine', 'vortioxetine, paroxetine', 'sertraline', 'Vortioxetine', 'escitalopram (10 mg/ daily) or duloxetine']","['I and CGI-E scores', 'Visual Analogue Scale (VAS), Total Pain Rating Index (T-PRI), Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A) and Clinical Global Impression Improvement (CGI-I) and Efficacy scales (CGI-E', 'VAS, T-PRI, HAM-A, HAM-D, CGI', 'efficacy and tolerability', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006430', 'cui_str': 'Burning mouth syndrome'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",150.0,0.0555323,"All the antidepressants (AD) were associated with a significant decrease in the VAS, T-PRI, HAM-A, HAM-D, CGI","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Adamo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pecoraro', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Coppola', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calabria', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Aria', 'Affiliation': 'Department of Economics and Statistics, University Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mignogna', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University Federico II of Naples, Naples, Italy.'}]",Oral diseases,['10.1111/odi.13602']
2959,32797473,"The effects of testosterone replacement therapy in men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin, and C-reactive protein.","INTRODUCTION


Age-related hypogonadism in men leads to abnormal body composition development and overproduction of inflammatory cytokines, and thus has atherogenic and potentially cancer promoting effects. The aim of the study was to assess the effect of agedependent testosterone deficiency replacement in men on body composition, serum leptin, adiponectin, and C-reactive protein levels.
MATERIAL AND METHODS


Men aged 50-65 years (56.0 ± 5.7, average ± SD), with total testosterone levels < 4 ng/mL, and clinical symptoms of hypogonadism were divided into two groups of 20 men and treated with testosterone (200 mg/two weeks intramuscularly) or placebo during 12 months.
RESULTS


Twelve months of treatment with testosterone led to body mass index (BMI) and fat mass (FM) decrease from 26.6 ± 2.1 to 26.1 ± 1.8 kg/m², p < 0.05, and from 17.0 ± 4.4 to 15.6 ± 4.0 kg, p < 0.05, respectively. Body mass index and FM did not change in placebo-receiving subjects. Serum leptin and highly selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2 ± 1.4 to 4.0 ± 1.2 μg/L, p < 0.05, and from 1.4 ± 1.2 to 1.0 ± 1.0 mg/L, p < 0.05 after 12 months, respectively. Adiponectin increased from 7.6 ± 2.5 μg/mL to 9.4 ± 2.8 μg/mL, p < 0.05 in the same time. In the placebo group serum leptin, adiponectin, and hsCRP levels did not change significantly.
CONCLUSIONS


Testosterone replacement in men with age-related hypogonadism causes a decrease in body mass index, fat mass, serum leptin, and C-reactive protein levels and increases serum adiponectin levels.",2020,"Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively.","['Men aged 50-65 years (56.0±5.7, average±SD), with total testosterone levels <4 ng/mL and clinical symptoms of hypogonadism were divided into two groups of 20 men and treated with', 'men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin and C-reactive protein']","['testosterone', 'testosterone deficiency replacement', 'Testosterone replacement', 'testosterone replacement therapy', 'placebo']","['body composition, serum leptin, adiponectin and C-reactive protein levels', 'body mass index, fat mass, serum leptin and C-reactive protein levels', 'serum leptin, adiponectin and hsCRP levels', 'serum adiponectin levels', 'body mass index (BMI) and fat mass (FM) decrease', 'Adiponectin', 'BMI and FM', 'Serum leptin and high-selective C-reactive protein (hsCRP) levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.0958921,"Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dudek', 'Affiliation': 'Department of Endocrinology, Medical Centrum of Postgraduate Studies, Bielański Hospital, Warsaw, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Kozakowski', 'Affiliation': 'Department of Endocrinology, Medical Centrum of Postgraduate Studies, Bielański Hospital, Warsaw, Poland. jkozakowski@cmkp.edu.pl.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zgliczyński', 'Affiliation': 'Department of Endocrinology, Medical Centrum of Postgraduate Studies, Bielański Hospital, Warsaw, Poland.'}]",Endokrynologia Polska,['10.5603/EP.a2020.0048']
2960,32795098,"Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial.","BACKGROUND


Standard administration of newer oral P2Y 12  inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.
METHODS


The FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y 12 -naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.
RESULTS


At 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5;  P <0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0;  P <0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4;  P =0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5;  P =0.016).
CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24.",2020,"CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel.","['122 P2Y 12 -naive patients with ST-segment-elevation myocardial infarction', 'Patients With ST-Segment-Elevation Myocardial Infarction', 'Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention', 'patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention', 'patients undergoing primary percutaneous coronary intervention']","['tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel', 'tirofiban', 'Cangrelor or tirofiban', 'prasugrel or ticagrelor', 'cangrelor, tirofiban, and prasugrel', 'Prasugrel', 'Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens', 'cangrelor', 'tirofiban and cangrelor']","['active metabolite concentration', 'prasugrel active metabolite concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]",,0.176081,"CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Avvedimento', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nagler', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital (M.N.), University of Bern, Switzerland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Minuz', 'Affiliation': 'Department of Medicine, Unit of General Medicine for the Study and Treatment of Hypertensive Disease, University of Verona, Policlinico GB Rossi, Italy (P.M.).'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.).'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Manavifar', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.).'}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'Cirillo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hunziker', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Belgium (P.V.).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico S Matteo, Italy (S.L.).'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Bern University Hospital, and Clinical Trials Unit, CTU Bern (D.H.), University of Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046928']
2961,32804248,Locking versus non-locking plates in fixation of extra-articular distal humerus fracture: a randomized controlled study.,"INTRODUCTION


Studies have shown that the use of nonlocking (reconstruction) plates in fixing distal humerus fractures may not yield stable fixation which therefore requires long immobilization and suboptimal functional results. There are reports showing that locking plates are biomechanically superior to nonlocking plates. The aim of this study was to compare elbow functional outcomes between locking and nonlocking plates in fixation of distal humerus fractures.
METHODS


A single-centre, randomized control study was conducted at an academic level 1 trauma centre. A total of 60 patients with type 13-A fracture (AO/OTA classification) were randomized into two equal groups, locking plates group, and nonlocking plates group. The primary outcome measure was the Mayo elbow performance score (MEPS) at one year. Secondary outcomes measures were elbow flexion/extension arc, union, operative time, and complications (e.g., infection, heterotrophic ossification).
RESULTS


The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group. The difference was found to be statically significant (P value = 0.01). Elbow flexion/extension arc of motion at one year was 116° ± 15° in locking plates group and 113° ± 28° in nonlocking plates. The difference was not found to be statistically significant (P value = 0.17).
CONCLUSION


Both implants yield similar results, with locking plates showing slightly better clinical scores.",2020,The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group.,"['A single-centre, randomized control study was conducted at an academic level 1 trauma centre', 'extra-articular distal humerus fracture', '60 patients with type 13-A fracture (AO/OTA classification']","['locking plates group, and nonlocking plates group', 'Elbow flexion/extension arc of motion at one year was\xa0116° ± 15', 'nonlocking (reconstruction) plates', 'locking and nonlocking plates', 'Locking versus non-locking plates']","['elbow flexion/extension arc, union, operative time, and complications (e.g., infection, heterotrophic ossification', 'elbow functional outcomes', 'Mayo Elbow Performance Score (MEPS', 'Mayo elbow performance score (MEPS']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0449834,The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group.,"[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Galal', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt. Sherif.Galal@kasralainy.edu.eg.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mattar', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}, {'ForeName': 'Alaa Mohy Eldin', 'Initials': 'AME', 'LastName': 'Solyman', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ezzat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}]",International orthopaedics,['10.1007/s00264-020-04770-z']
2962,32798927,A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder.,"BACKGROUND


Music therapy is based on the use of musical elements by a trained and qualified therapist. Clinical researches have suggested that children with Autism Spectrum Disorders (ASD) may benefit from MT. In this regard, this study examines if MT is more effective than simply listening to music for children with ASD.
METHOD


A 8-month RCT has been carried out comparing music therapy (MT) to music listening (ML) for children with ASD aged from 4 to 7 years old. Thirty-seven participants were randomly assigned to one of the two groups (MT vs. ML). The outcome measures were the Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML).
RESULTS


CGI scores decreased more for participants in the MT than in the ML condition. This clinical improvement was associated with an improvement of autistic symptoms on lethargy and stereotypy ABC subscales.
CONCLUSION


Our findings suggest that music therapy is more efficient than music listening for children with ASD. The present study thus supports the consideration of MT as a rightful add-on to ASD healthcare programs.",2020,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","['children with ASD', 'children with ASD aged from 4 to 7 years old', 'children with autism spectrum disorder', 'Thirty-seven participants', 'children with Autism Spectrum Disorders (ASD']","['MT', 'music therapy', 'music therapy and music listening', 'music therapy (MT) to music listening (ML']","['autistic symptoms on lethargy and stereotypy ABC subscales', 'Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML', 'CGI scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0933362,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rabeyron', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France. Electronic address: thomas.rabeyron@univ-lorraine.fr.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'Robledo Del Canto', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre for Music and Science, University of Cambridge, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Carasco', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bisson', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bodeau', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Vrait', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': 'Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Inserm U1114, France; Collègue Universitaire des Médecines Intégratives et Complémentaires (CUMIC), Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}]",Psychiatry research,['10.1016/j.psychres.2020.113377']
2963,32799709,"Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial.","Background High-density lipoprotein (HDL) cholesterol has inverse association with cardiovascular disease. HDL possesses anti-inflammatory properties in vitro, but it is unknown whether this may be protective in individuals with inflammation. Methods and Results The functional capacity of HDL to inhibit oxidation of oxidized low-density lipoprotein (ie, the HDL inflammatory index; HII) was measured at baseline and 12 months after random allocation to rosuvastatin or placebo in a nested case-control study of the JUPITER (Justification for the Use of Statins in Prevention: An Intervention Evaluating Rosuvastatin) trial. There were 517 incident cases of cardiovascular disease and all-cause mortality compared to 517 age- and sex-matched controls. Multivariable conditional logistic regression was used to examine associations of HII with events. Median baseline HII was 0.54 (interquartile range, 0.50-0.59). Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference). HII had a nonlinear relationship with incident events. Compared with the reference group (HII 0.5-1.0) with the lowest event rates, participants with baseline HII ≤0.5 had significantly increased risk of cardiovascular disease/mortality (adjusted hazard ratio, 1.53; 95% CI, 1.06-2.21;  P =0.02). Furthermore, there was significant ( P =0.002) interaction for HDL particle number with HII, such that having more HDL particles was associated with decreased risk only when HDL was anti-inflammatory. Conclusions In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0. This nonlinear relationship of anti-inflammatory HDL function with risk may account in part for the HDL paradox. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00239681.",2020,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference).","['individuals with inflammation', 'In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0']","['rosuvastatin', 'rosuvastatin or placebo', 'Registration URL', ' High-density lipoprotein (HDL) cholesterol', 'placebo']","['risk of cardiovascular disease/mortality', 'Median baseline HII', 'Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality', 'cardiovascular disease and all-cause mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",517.0,0.234502,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference).","[{'ForeName': 'Oluremi N', 'Initials': 'ON', 'LastName': 'Ajala', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Zareen', 'Initials': 'Z', 'LastName': 'Farukhi', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Adelman', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Collins', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Genetics University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016507']
2964,32807179,High-intensity interval training and health-related quality of life in de novo heart transplant recipients - results from a randomized controlled trial.,"BACKGROUND


Studies on the effect of high-intensity interval training (HIT) compared with moderate intensity continuous training (MICT) on health-related quality of life (HRQoL) after heart transplantation (HTx) is scarce. No available studies among de novo HTx recipients exists. This study aimed to investigate the effect of HIT vs. MICT on HRQoL in de novo recipients.
METHODS


The HITTS study randomized eighty-one de novo HTx recipients to receive either HIT or MICT (1:1). The HIT intervention were performed with 2-4 interval bouts with an intensity of 85-95% of maximal effort. The MICT group exercised at an intensity of 60-80% of their maximal effort with a duration of 25 min. HRQoL was assessed by the Short Form-36 version 2 (SF-36v2) and the Hospital Anxiety and Depression Scale, mean 11 weeks after surgery and after a nine months' intervention. The participants recorded their subjective effect of the interventions on their general health and well-being on a numeric visual analogue scale. Clinical examinations and physical tests were performed. Differences between groups were investigated with independent Student t-tests and with Mann-Whitney U tests where appropriate. Within-group differences were analyzed with Paired-Sample t-tests and Wilcoxon Signed Rank tests. Correlations between SF-36 scores and VO 2peak  were examined with Pearson's correlations.
RESULTS


Seventy-eight participants completed the intervention. Both exercise modes were associated with improved exercise capacity on the physical function scores of HRQoL. Mental health scores remained unchanged. No differences in the change in HRQoL between the groups occurred except for Role Emotional subscale with a larger increase in the HIT arm. Better self-reported physical function was associated with higher VO 2peak  and muscle strength.
CONCLUSION


HIT and MICT resulted in similar mean changes in HRQoL the first year after HTx. Both groups experienced significant improvements in the physical SF-36v2.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT01796379 Registered 18 February 2013.",2020,No differences in the change in HRQoL between the groups occurred except for Role Emotional subscale with a larger increase in the HIT arm.,"['de novo recipients', 'Seventy-eight participants completed the intervention', 'de novo heart transplant recipients ']","['high-intensity interval training (HIT', 'High-intensity interval training', 'MICT', 'HIT or MICT', 'moderate intensity continuous training (MICT', 'HIT vs. MICT']","['health-related quality of life (HRQoL', 'physical function scores of HRQoL. Mental health scores', 'VO 2peak  and muscle strength', 'HRQoL', 'general health and well-being on a numeric visual analogue scale', 'Short Form-36 version 2 (SF-36v2) and the Hospital Anxiety and Depression Scale', 'SF-36 scores and VO 2peak', 'physical SF-36v2', 'Role Emotional subscale']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",81.0,0.0986644,No differences in the change in HRQoL between the groups occurred except for Role Emotional subscale with a larger increase in the HIT arm.,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway. katrine.rolid@medisin.uio.no.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Kjell I', 'Initials': 'KI', 'LastName': 'Pettersen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Dall', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01536-4']
2965,32808209,Lifestyle Habits Associated with Weight Regain After Intentional Loss in Primary Care Patients Participating in a Randomized Trial.,"BACKGROUND


Though long-term weight loss maintenance is the treatment goal for obesity, weight regain is typical and few studies have evaluated lifestyle habits associated with weight regain.
OBJECTIVE


To identify dietary and physical activity habits associated with 6- and 24-month weight regain among participants in a weight loss maintenance clinical trial.
DESIGN


Secondary analysis of randomized clinical trial data.
PARTICIPANTS


Adult primary care patients with recent, intentional weight loss of at least 5%.
MAIN MEASURES


Lifestyle habits included consumption of low-fat foods, fish, desserts, sugary beverages, fruits, and vegetables and eating at restaurants from the Connor Diet Habit Survey; moderate-vigorous physical activity by self-report; steps recorded by a pedometer; and sedentary behavior by self-report. The outcome variable was weight change at 6 and 24 months. Linear regression models estimated adjusted associations between changes in weight and changes in dietary and physical activity habits.
KEY RESULTS


Overall, participants (mean (SD): 53.4 (12.2) years old; 26% male; 88% white) maintained weight loss at 6 months (n = 178, mean (SD): - 0.02 (5.70)% change) but began to regain weight by 24 months (n = 157, mean (SD): 4.22 (9.15)% increase). When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up. In addition, more sedentary behavior was associated with weight regain at 6 months while reduced consumption of low-fat foods, and more desserts and sugary beverages were associated with weight regain at 24 months.
CONCLUSIONS


Consuming less fish, fewer steps per day, and more frequent restaurant eating were most consistently associated with weight regain in primary care patients. Primary care providers may consider addressing specific lifestyle behaviors when counseling patients after successful weight loss.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01946191.",2020,"When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up.","['participants in a weight loss maintenance clinical trial', 'Adult primary care patients with recent, intentional weight loss of at least 5']",[],"['weight regain', 'weight change', 'weight and changes in dietary and physical activity habits', 'physical activity', 'consumption of low-fat foods, fish, desserts, sugary beverages, fruits, and vegetables and eating at restaurants from the Connor Diet Habit Survey; moderate-vigorous physical activity by self-report; steps recorded by a pedometer; and sedentary behavior by self-report', 'Weight Regain', 'weight loss']","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453839', 'cui_str': 'Low fat food'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0359383,"When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up.","[{'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA. bbarone@pitt.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tudorascu', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Comer', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Huber', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Laurey R', 'Initials': 'LR', 'LastName': 'Simkin-Silverman', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06056-x']
2966,32808315,Variance formulae for multiphase stepped wedge cluster randomized trial.,"In a multiphase stepped wedge cluster randomized trial (MSW-CRT), more than one intervention will be initiated on each sequence in a fixed order. Hence, with the MSW-CRT design, the effect of the first intervention can be evaluated when compared to control, as well as the added-on effects of the subsequent interventions. Studies that use MSW-CRT have been proposed, but properties of this design have not been explicitly studied. We derive closed-form variance formulae to test the interventions' effects, which can be readily used for sample size and power calculation. Additionally, we provide relationships between variances to test the interventions' effects and design parameters. Under special conditions, some important properties include: (i) the variances to test different interventions' effects (ie, the first intervention effect and the second intervention effect) may be same; (ii) as the cluster-period mean autocorrelation increases, the variance to test an intervention effect may first increase and then decrease; (iii) as the amount of periods between the initiations of two interventions (ie, lag) increases, the variance to test an intervention effect may remain unchanged. We illustrate the relationships between power and design parameters using the variance formulae. From a few illustrative examples, we observe that the statistical test that uses data only relevant to a specific intervention has inferior power (relative power loss <15%) compared to the test when using all the study data. Also, power is reduced when both the total number of periods and lag are decreased simultaneously (relative power loss <20%).",2020,"From a few illustrative examples, we observe that the statistical test that uses data only relevant to a specific intervention has inferior power (relative power loss <15%) compared to the test when using all the study data.",[],['MSW-CRT'],[],[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],,0.0335308,"From a few illustrative examples, we observe that the statistical test that uses data only relevant to a specific intervention has inferior power (relative power loss <15%) compared to the test when using all the study data.","[{'ForeName': 'Pengyue', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Biomedical Informatics, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Shoben', 'Affiliation': 'Division of Biostatistics, College of Public Health, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Internal Medicine/Endocrinology, and Diabetes and Metabolism, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Fernandez', 'Affiliation': 'Department of Biomedical Informatics, Ohio State University, Columbus, Ohio, USA.'}]",Statistics in medicine,['10.1002/sim.8716']
2967,32809893,Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial.,"Background The cysteine protease legumain is increased in patients with atherosclerosis, but its causal role in atherogenesis and cardiovascular disease is still unclear. The aim of the study was to investigate the association of legumain with clinical outcome in a large cohort of patients with acute coronary syndrome. Methods and Results Serum levels of legumain were analyzed in 4883 patients with acute coronary syndrome from a substudy of the PLATO (Platelet Inhibition and Patient Outcomes) trial. Levels were analyzed at admission and after 1 month follow-up. Associations between legumain and a composite of cardiovascular death, spontaneous myocardial infarction or stroke, and its individual components were assessed by multivariable Cox regression analyses. At baseline, a 50% increase in legumain level was associated with a hazard ratio (HR) of 1.13 (95% CI, 1.04-1.21),  P =0.0018, for the primary composite end point, adjusted for randomized treatment. The association remained significant after adjustment for important clinical and demographic variables (HR, 1.10; 95% CI, 1.02-1.19;  P =0.013) but not in the fully adjusted model. Legumain levels at 1 month were not associated with the composite end point but were negatively associated with stroke (HR, 0.62; 95% CI, 0.44-0.88;  P =0.0069), including in the fully adjusted model (HR, 0.57; 95% CI, 0.37-0.88;  P =0.0114). Conclusions Baseline legumain was associated with the primary outcome in patients with acute coronary syndrome, but not in the fully adjusted model. The association between high levels of legumain at 1 month and decreased occurrence of stroke could be of interest from a mechanistic point of view, illustrating the potential dual role of legumain during atherogenesis and acute coronary syndrome. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00391872.",2020,"Legumain levels at 1 month were not associated with the composite end point but were negatively associated with stroke (HR, 0.62; 95% CI, 0.44-0.88;  P =0.0069), including in the fully adjusted model (HR, 0.57; 95% CI, 0.37-0.88;  P =0.0114).","['patients with acute coronary syndrome', 'patients with atherosclerosis', 'Acute Coronary Syndromes', '4883 patients with acute coronary syndrome']",['Legumain'],"['Legumain levels', 'cardiovascular death, spontaneous myocardial infarction or stroke, and its individual components', 'legumain level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0104398', 'cui_str': 'Legumain'}]","[{'cui': 'C0104398', 'cui_str': 'Legumain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",4883.0,0.097858,"Legumain levels at 1 month were not associated with the composite end point but were negatively associated with stroke (HR, 0.62; 95% CI, 0.44-0.88;  P =0.0069), including in the fully adjusted model (HR, 0.57; 95% CI, 0.37-0.88;  P =0.0114).","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gregersen', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Annika E', 'Initials': 'AE', 'LastName': 'Michelsen', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Ngoc Nguyen', 'Initials': 'NN', 'LastName': 'Lunde', 'Affiliation': 'Section of Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Norway.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Åkerblom', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Tatevik G', 'Initials': 'TG', 'LastName': 'Lakic', 'Affiliation': 'Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Skjelland', 'Affiliation': 'Department of Neurology Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Ryeng Skagen', 'Affiliation': 'Department of Neurology Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Disease Heart, Lung and Vascular Institute Academic Health Center Cincinnati OH.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindbäck', 'Affiliation': 'Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca Research and Development Gothenburg Sweden.'}, {'ForeName': 'Rigmor', 'Initials': 'R', 'LastName': 'Solberg', 'Affiliation': 'Section of Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Norway.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Johansen', 'Affiliation': 'Section of Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Norway.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease University of Sheffield Sheffield United Kingdom.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Kontny', 'Affiliation': 'Department of Cardiology Stavanger University Hospital Stavanger Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Halvorsen', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016360']
2968,32811690,"Corrigendum to ""Influence of front-of-pack labelling and regulated nutrition claims on consumers' perceptions of product healthfulness and purchase intentions: A randomized controlled trial"" [Appetite 149 (1 June 2020) 104629].",,2020,,"[""consumers' perceptions of product healthfulness and purchase intentions""]",['pack labelling and regulated nutrition claims'],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0741049,,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; Faculty of Law, University of Ottawa, 57 Louis Pasteur St, Ottawa, Ontario, K1N 6N5, Canada.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mary.labbe@utoronto.ca.""}]",Appetite,['10.1016/j.appet.2020.104809']
2969,32812316,Application of WeChat-assisted peri-operative care in children with congenital megacolon.,"AIM


This study explored the clinical effects of WeChat-based peri-operative care on parents of children with congenital megacolon.
METHODS


Participants were randomly divided into WeChat group and telephone group. This study explored parents' knowledge of the care of children with megacolon, the follow-up rate of children, post-operative defaecation function and complications.
RESULTS


WeChat group scored better in nursing knowledge than telephone group, and the difference was statistically significant. The lost follow-up rate in WeChat group was lower than that in telephone group, and the difference was statistically significant. Post-operative defaecation was also better in the WeChat group than in the phone group. Most complications in the phone group were significantly higher than those in the WeChat group.
CONCLUSION


Peri-operative care for parents of children with megacolon through WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.",2020,"WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.","['parents of children with megacolon through', 'Participants', 'parents of children with congenital megacolon', 'children with congenital megacolon']","['WeChat-assisted peri-operative care', 'WeChat-based peri-operative care', 'Peri-operative care', 'WeChat group and telephone']",['nursing knowledge'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025160', 'cui_str': 'Megacolon'}, {'cui': 'C0019569', 'cui_str': ""Hirschsprung's disease""}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0203934,"WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'YiFan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'DianMing', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'JianXi', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}]",Journal of paediatrics and child health,['10.1111/jpc.14990']
2970,32812667,Automated exchange compared to manual and simple blood transfusion attenuates rise in ferritin level after 1 year of regular blood transfusion therapy in chronically transfused children with sickle cell disease.,"BACKGROUND


Optimal strategies for regular blood transfusion therapy are not well defined in sickle cell disease (SCD). This analysis tested the hypothesis that in the first of year of regular transfusions, when chelation therapy use is minimal, automated exchange transfusion would be the superior method for attenuating the rise in ferritin levels compared to simple and manual exchange transfusions.
STUDY DESIGN AND METHODS


The Silent Cerebral Infarct Multi-Center Clinical Trial randomly allocated children with SCD and silent cerebral infarcts to receive standard care or regular transfusions with a target pre-transfusion HbS concentration ≤ 30% and minimum hemoglobin level > 9.0 g/dL. Participants with at least nine transfusions and sufficient ferritin testing in the first year of the trial were included in a planned secondary analysis. Ferritin levels by the end of the first study year were compared between participants receiving automatic exchange transfusion, manual exchange transfusion, and simple transfusion.
RESULTS


A total of 83 participants were analyzed. During the first year of the study, 75.9% of the participants had >80% of transfusions via one transfusion method. At baseline no significant differences in ferritin levels were observed in the three transfusion groups (p = 0.1). After 1 year of transfusions the median (interquartile range) ferritin levels in the simple transfusion (n = 40), manual exchange transfusion (n = 34) and automatic exchange transfusion (n = 9) groups were 1800 ng/mL (1426-2204 ng/mL), 1530 ng/mL (1205-1805 ng/mL), and 355 ng/mL (179-579 ng/mL), respectively (p < 0.001).
CONCLUSION


Automated exchange transfusion, when compared to other transfusion methods, is the optimal transfusion strategy for attenuating increase in ferritin levels in children with SCD.",2020,"Automated exchange transfusion, when compared to other transfusion methods, is the optimal transfusion strategy for attenuating increase in ferritin levels in children with SCD.","['A total of 83 participants were analyzed', 'chronically transfused children with sickle cell disease', 'children with SCD']","['standard care or regular transfusions with a target pre-transfusion HbS concentration\u2009≤\u200930% and minimum hemoglobin level\u2009>\u20099.0 g/dL. Participants with at least nine transfusions and sufficient ferritin testing', 'Automated exchange compared to manual and simple blood transfusion']","['Ferritin levels', 'ferritin levels', 'ferritin level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}]",83.0,0.190826,"Automated exchange transfusion, when compared to other transfusion methods, is the optimal transfusion strategy for attenuating increase in ferritin levels in children with SCD.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Department of Epidemiology, Vitalant Research Institute, San Francisco, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rodeghier', 'Affiliation': 'Rodeghier Consultants, Chicago, Illinois, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, Vanderbilt-Meharry Center for Excellence in Sickle Cell Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]",Transfusion,['10.1111/trf.15982']
2971,32818946,Greater Attendance at a Community Weight Loss Programme over the First 12 Weeks Predicts Weight Loss at 2 Years.,"BACKGROUND


There is considerable heterogeneity in long-term weight loss among people referred to obesity treatment programmes. It is unclear whether attendance at face-to-face sessions in the early weeks of the programme is an independent predictor of long-term success.
OBJECTIVE


To investigate whether frequency of attendance at a community weight loss programme over the first 12 weeks is associated with long-term weight change.
METHODS


Participants were randomised to receive brief support only (control, n = 211), or a weight loss programme for 12 weeks (n = 530) or 52 weeks (n = 528). This study included participants with data on session attendance over the first 12 weeks (n = 889) compared to the control group. The association between attendance (continuously) and weight loss was explored using a linear model. A multi-level mixed-effects linear model was used to investigate whether attendance (categorised as 0, 1, 2-5, 6-9, and 10-12 sessions) was associated with weight loss at 3, 12, and 24 months compared to the control.
RESULTS


For every session attended in the first 12 weeks, the average weight loss was -0.259 kg/session at 24 months (p = 0.005). Analysis by attendance group found only those attending 10-12 sessions had significantly greater weight loss (-7.5 kg [95% CI -8.1 to -6.9] at 12 months; -4.7 kg [95% CI -5.3 to -4.1] at 24 months) compared to the control group (-3.4 [95% CI -4.5 to -2.4] at 12 months, -2.5 [95% CI -3.5 to -1.5] at 24 months). Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
CONCLUSIONS


Greater attendance at a community weight loss programme in the first 12 weeks is associated with enhanced weight loss up to 24 months. Regular attendance at a programme could be used as a criterion for continued provision of weight loss services to maximise the cost-effectiveness of interventions.",2020,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
","['Participants', 'participants with data on session attendance over the first 12 weeks (n = 889', 'people referred to obesity treatment programmes']",['weight loss programme'],"['weight loss', 'enhanced weight loss', 'attendance (continuously) and weight loss', 'average weight loss']","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0377466,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, carmen.piernas-sanchez@phc.ox.ac.uk.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacLean', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Woolston', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000509131']
2972,32820015,Entospletinib in Combination with Induction Chemotherapy in Previously Untreated Acute Myeloid Leukemia: Response and Predictive Significance of  HOXA9  and  MEIS1  Expression.,"PURPOSE


Spleen tyrosine kinase (SYK) signaling is a proposed target in acute myeloid leukemia (AML). Sensitivity to SYK inhibition has been linked to  HOXA9  and  MEIS1  overexpression in preclinical studies. This trial evaluated the safety and efficacy of entospletinib, a selective inhibitor of SYK, in combination with chemotherapy in untreated AML.
PATIENTS AND METHODS


This was an international multicenter phase Ib/II study, entospletinib dose escalation (standard 3+3 design between 200 and 400 mg twice daily) + 7+3 (cytarabine + daunorubicin) in phase Ib and entospletinib dose expansion (400 mg twice daily) + 7+3 in phase II.
RESULTS


Fifty-three patients ( n  = 12, phase Ib and  n  = 41, phase II) with previously untreated  de novo  ( n  = 39) or secondary ( n  = 14) AML were enrolled (58% male; median age, 60 years) in this study. The composite complete response with entospletinib + 7+3 was 70%. Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared with patients with below median  HOXA9  and  MEIS1  expression. Common adverse events were cytopenias, febrile neutropenia, and infection. There were no dose-limiting toxicities. Entospletinib-related skin rash and hyperbilirubinemia were also observed.
CONCLUSIONS


Entospletinib with intensive chemotherapy was well-tolerated in patients with AML. Improved survival was observed in patients with  HOXA9/MEIS1  overexpression, contrasting published data demonstrating poor survival in such patients. A randomized study will be necessary to determine whether entospletinib was a mediator this observation.",2020,Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression.,"['Fifty-three patients (n=12 phase 1b, n=41 phase 2) with previously untreated de novo (n=39) or secondary (n=14) AML enrolled (58% male, median age 60 years', 'acute myeloid leukemia (AML']","['entospletinib dose escalation (standard 3+3 design between 200 mg and 400 mg BID) + 7+3 (cytarabine + daunorubicin', 'Induction Chemotherapy', 'Entosplentib with intensive chemotherapy']","['Entospletinib-related skin rash and hyperbilirubinemia', 'febrile neutropenia, and infection', 'no dose-limiting toxicities', 'overall survival', 'Improved survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0519043,Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression.,"[{'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Walker', 'Affiliation': 'The Ohio State University, Columbus, Ohio. Alison.Walker@osumc.edu.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Blachly', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Bhatnagar', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Mims', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Orwick', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Lin', 'Affiliation': 'University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Howland E', 'Initials': 'HE', 'LastName': 'Crosswell', 'Affiliation': 'Bon Secours Mercy Health System, Greenville, South Carolina.'}, {'ForeName': 'Danjie', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Minden', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Oellerich', 'Affiliation': 'Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Arati V', 'Initials': 'AV', 'LastName': 'Rao', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, Georgia.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1064']
2973,32816639,Buspirone decreases susceptibility to hypocapnic central sleep apnea in chronic SCI patients.,"Spinal cord injury (SCI) is a risk factor for central sleep apnea (CSA). Previous studies in animal models with SCI have demonstrated a promising recovery in respiratory and phrenic nerve activity post-injury induced by the systemic and local administration of serotonin receptor agonists such as Buspirone and Trazodone. Human trials must be performed to determine whether individuals with SCI respond similarly. We hypothesized that Buspirone and Trazodone would decrease the propensity to hypocapnic CSA during sleep. We studied eight males with chronic SCI and sleep-disordered breathing (SDB) [age: 48.8 ± 14.2 yr; apnea-hypopnea index (AHI): 44.9 ± 23.1] in a single-blind crossover design. For 13 days, participants were randomly assigned either Buspirone (7.5-15 mg twice daily), Trazodone (100 mg), or a placebo followed by a 14-day washout period before crossing over to the other interventions. Study nights included polysomnography and induction of CSA using a noninvasive ventilation protocol. We assessed indexes of SDB, CO 2  reserve, apneic threshold (AT), controller gain (CG), plant gain (PG), and ventilatory parameters. CO 2  reserve was significantly widened on Buspirone (-3.6 ± 0.9 mmHg) compared with both Trazodone (-2.5 ± 1.0 mmHg,  P  = 0.009) and placebo (-1.8 ± 1.5 mmHg,  P  < 0.001) but not on Trazodone vs. placebo ( P  = 0.061). CG was significantly decreased on Buspirone compared with placebo (1.8 ± 0.4 vs. 4.0 ± 2.0 L/(mmHg·min),  P  = 0.025) but not on Trazodone compared with placebo (2.5 ± 1.1 vs. 4.0 ± 2.0 L/(mmHg·min);  P  = 0.065). There were no significant differences for PG, AT, or any SDB indexes (AHI, obstructive apnea index, central apnea index, oxygen desaturation index). The administration of Buspirone decreased the susceptibility to induced hypocapnic central apnea by reducing chemosensitivity and increasing CO 2  reserve in chronic SCI patients. NEW & NOTEWORTHY  This research study is novel as it is the first study in a humans that we are aware of that demonstrates the ability of Buspirone to increase CO 2  reserve and hence decrease susceptibility to hypocapnic central apnea in patients with spinal cord injury.",2020,"There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI).","['individuals with SCI respond similarly', '8 males with chronic SCI and sleep-disordered breathing (SDB)(Age', 'Chronic SCI Patients', 'chronic SCI patients']","['Trazodone', 'Buspirone and Trazodone', 'Buspirone', 'Trazodone vs. placebo', 'placebo']","['PG, AT or any SDB indices (AHI, OAI, CAI, ODI', 'CO 2  reserve', 'SDB, CO 2  reserve, apneic threshold (AT), controller gain (CG), plant gain (PG) and ventilatory parameters', 'CG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",8.0,0.0422913,"There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI).","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Maresh', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Prowting', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vaughan', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kruppe', 'Affiliation': ''}, {'ForeName': 'Bander', 'Initials': 'B', 'LastName': 'Alsabri', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Yarandi', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Abdulghani', 'Initials': 'A', 'LastName': 'Sankari', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00435.2020']
2974,32780636,Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial.,"Objective:  Several intraarticular injections, including dextrose and lidocaine, are reported to reduce pain and dysfunction in temporomandibular dysfunction (TMD) and increase maximal jaw opening; our goal was to determine whether dextrose/lidocaine outperforms sterile water/lidocaine for TMD.  Design:  Pragmatic randomized controlled trial.  Setting:  Outpatient clinic.  Subjects:  Chronic (≥3 months) of moderate-to-severe (≥6/10) jaw or facial pain meeting research-specific TMD criteria.  Intervention:  Blinded intraarticular dextrose prolotherapy (DPT) (20% dextrose/0.2% lidocaine) versus intraarticular lidocaine (0.2% lidocaine in sterile water) at 0, 1, and 2 months. Participants were then unblinded and offered DPT by request for 9 additional months.  Main outcome measures:  Primary: Numerical Rating Scale (0-10 points) score for facial pain and jaw dysfunction; percentage achieving ≥50% improvement in pain and dysfunction (0, 3, and 12 months). Secondary: Maximal interincisal opening (MIO; 0 and 3 months). Intention-to-treat analysis was by joint using mixed-model regression.  Results:  Randomization of 29 participants (25 female, 47 ± 17 years, 43 joints) produced similar groups. Three-month pain and dysfunction improvements were similar, but more DPT-treated joints improved by ≥50% in pain (17/22 vs. 6/21;  p  = 0.028). The MIO improved in both groups (5.6 ± 5.8 mm vs. 5.1 ± 7.0 mm;  p  = 0.70). From 3 to 12 months, minimal DPT was received by original DPT and lidocaine recipients, 0.5 ± 0.9 and 0.6 ± 1.5 injections, respectively, with only 2 out of 21 joints in the original lidocaine group receiving more than 1 dextrose injection after 3 months. Twelve-month analysis revealed that joints in the original DPT group improved more in jaw pain (4.8 ± 2.4 points vs. 2.6 ± 2.9 points;  p  = 0.026) and jaw dysfunction (5.3 ± 2.6 points vs. 2.7 ± 2.3 points;  p  = 0.013). More DPT than lidocaine-treated joints improved by ≥50% in both pain (19/22 vs. 5/21;  p  = 0.003) and dysfunction (17/22 vs. 7/21;  p  = 0.040). There were no adverse events; satisfaction was high.  Conclusions:  Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).",2020,Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).,"['Subjects:  Chronic (≥3 months) of moderate-to-severe (≥6/10) jaw or facial pain meeting research-specific TMD criteria', '29 participants (25 female, 47\u2009±\u200917 years, 43 joints) produced similar groups', 'Temporomandibular Dysfunction']","['intraarticular lidocaine (0.2% lidocaine', 'lidocaine', 'Dextrose Prolotherapy Versus Lidocaine Injection', 'dextrose/lidocaine', 'intraarticular dextrose prolotherapy (DPT) (20% dextrose/0.2% lidocaine', 'Intraarticular DPT', 'dextrose and lidocaine']","['pain and dysfunction in temporomandibular dysfunction (TMD', 'pain and dysfunction', 'MIO', 'Maximal interincisal opening (MIO; 0 and 3 months', 'jaw dysfunction', 'adverse events; satisfaction', 'dysfunction', 'jaw pain', 'Numerical Rating Scale (0-10 points) score for facial pain and jaw dysfunction; percentage achieving ≥50% improvement in pain and dysfunction', 'pain and dysfunction improvements']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0636923', 'cui_str': 'diphenylthiosulfinate'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0236000', 'cui_str': 'Jaw pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.326994,Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Zarate', 'Affiliation': 'Private Practice Family Medicine, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Ricardo Daniel', 'Initials': 'RD', 'LastName': 'Frusso', 'Affiliation': 'Private Practice Family Medicine, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Kenneth Dean', 'Initials': 'KD', 'LastName': 'Reeves', 'Affiliation': 'Private Practice Physical Medicine and Rehabilitation, Roeland, Kansas, USA.'}, {'ForeName': 'An-Lin', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Department of Biomedical and Health Informatics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rabago', 'Affiliation': 'Department of Family and Community Medicine, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0207']
2975,32788567,Levosimendan in the treatment of patients with acute cardiac conditions: an expert opinion of the Association of Intensive Cardiac Care of the Polish Cardiac Society.,"Levosimendan is a new inodilator which involves 3 main mechanisms: increases the calcium sensitivity of cardiomyocytes, acts as a vasodilator due to the opening of potassium channels, and has a cardioprotective effect. Levosimendan is mainly used in the treatment of acute decompensated heart failure (class IIb recommendation according to the European Society of Cardiology guidelines). However, numerous clinical trials indicate the validity of repeated infusions of levosimendan in patients with stable heart failure as a bridge therapy to heart transplantation, and in patients with accompanying right ventricular heart failure and pulmonary hypertension. Due to the complex mechanism of action, including the cardioprotective and anti- -aggregating effect, the use of levosimendan may be particularly beneficial in acute coronary syndromes, preventing the occurrence of acute heart failure. There are data indicating that levosimendan administered prior to cardiac surgery may improve outcomes in patients with severely impaired left ventricular function. The multidirectional mechanism of action also affects other organs and systems. The positive effect of levosimendan in the treatment of cardiorenal and cardiohepatic syndromes has been shown. It has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis. However, with inconclusive results of previous studies, there is aneed for awell-designed multicenter randomized placebo-‑controlled study, including an adequately large group of outpatients with chronic advanced systolic heart failure.",2020,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","['patients with accompanying right ventricle heart failure and pulmonary hypertension', 'patients with stable heart failure', 'patients with acute coronary syndromes', 'patients with severely impaired left ventricle function', 'patients with acute cardiac conditions', 'outpatients with chronic advanced systolic heart failure']","['levosimendan', 'Levosimendan', 'levosimandan', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0225897', 'cui_str': 'Left cardiac ventricular structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0197177,"Levosimendan has a safe and predictable profile of action, does not induce tolerance, and shows no adverse effects affecting patients survival or prognosis.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Tycińska', 'Affiliation': 'Department of Cardiology, Medical University of Białystok, Białystok, Poland. agnieszka.tycinska@gmail.com'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Gierlotka', 'Affiliation': 'Department of Cardiology, University Hospital in Opole, Institute of Medical Sciences, University of Opole, Opole, Poland'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Bugajski', 'Affiliation': 'Department of Cardiology, University Hospital in Opole, Institute of Medical Sciences, University of Opole, Opole, Poland'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Deja', 'Affiliation': 'Department of Cardiac Surgery, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Depukat', 'Affiliation': 'Department of Cardiology and Cardiovascular Interventions, University Hospital, Kraków, Poland'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Gruchała', 'Affiliation': '1st Department of Cardiology, Medical University of Gdańsk, Gdańsk, Poland'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Grześk', 'Affiliation': 'Department of Cardiology and Clinical Pharmacology, Faculty of Health Sciences Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland'}, {'ForeName': 'Jarosław D', 'Initials': 'JD', 'LastName': 'Kasprzak', 'Affiliation': 'I Department and Chair of Cardiology, Bieganski Hospital, Medical University of Lodz, Łódź, Poland'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kubica', 'Affiliation': 'Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kucewicz-Czech', 'Affiliation': 'Department of Cardiac Anaesthesiology and Intensive Therapy, Medical University of Silesia, Katowice, Poland'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Leszek', 'Affiliation': 'Department of Heart Failure and Transplantology, National Institute of Cardiology, Warsaw, Poland'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Płonka', 'Affiliation': 'Department of Cardiology, University Hospital in Opole, Institute of Medical Sciences, University of Opole, Opole, Poland'}, {'ForeName': 'Bożena', 'Initials': 'B', 'LastName': 'Sobkowicz', 'Affiliation': 'Department of Cardiology, Medical University of Białystok, Białystok, Poland'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Straburzyńska-Migaj', 'Affiliation': '1st Department of Cardiology, University of Medical Sciences in Poznan, University Hospital of Lord’s Transfiguration, Poznań, Poland'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wilk', 'Affiliation': 'Department of Cardiology, Medical University of Białystok, Białystok, Poland'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Zawiślak', 'Affiliation': 'Intensive Cardiac Care Unit, University Hospital, Kraków, Poland'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zymliński', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wrocław, Poland; Centre for Heart Diseases, University Hospital, Wrocław, Poland'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stępińska', 'Affiliation': 'Department of Intensive Cardiac Therapy, National Institute of Cardiology, Warsaw, Poland'}]",Kardiologia polska,['10.33963/KP.15551']
2976,32785689,Markers of Iron Flux during Testosterone-Mediated Erythropoiesis in Older Men with Unexplained or Iron-Deficiency Anemia.,"CONTEXT


Testosterone treatment of hypogonadal men improves their hemoglobin, but the mechanism is not understood.
OBJECTIVE


To investigate possible mechanisms by which testosterone stimulates erythropoiesis in hypogonadal older men with unexplained or iron-deficiency anemia.
DESIGN


The Anemia Trial of The Testosterone Trials, a placebo-controlled study in older, hypogonadal men.
SETTING


Twelve academic medical centers.
PARTICIPANTS


A total of 95 hypogonadal men (testosterone < 275 ng/mL) ≥65 years with anemia (hemoglobin < 12.7 g/dL). They were classified as having unexplained (n = 58) or iron deficiency anemia (n = 37).
INTERVENTION


Testosterone or placebo gel for 1 year.
MAIN OUTCOME MEASURES


Markers of iron metabolism during the first 3 months of treatment.
RESULTS


Testosterone replacement significantly (P < 0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% confidence interval, 0.31-0.85). Testosterone replacement tended to increase hemoglobin in the 37 men who had iron deficiency (0.38 g/dL; -0.19, 0.95), but the response was more variable and not statistically significant (P = 0.19). In men with unexplained anemia, testosterone replacement suppressed hepcidin (-8.2 ng/mL; -13.7, -2.7; P = 0.004) and ferritin (-19.6 µg/L; -32.8, -6.3; P = 0.004), but in men with iron deficiency, testosterone replacement did not. The decrease in hepcidin was moderately correlated with the increase in hemoglobin in the men with unexplained anemia (correlation coefficient -0.35, P = 0.01) but not in those with iron deficiency anemia (correlation coefficient -0.07, P = 0.73).
CONCLUSIONS


Testosterone replacement of older hypogonadal men with unexplained anemia stimulates erythropoiesis associated with increased iron mobilization. This effect appears to be attenuated by iron deficiency.",2020,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","['older, hypogonadal men', 'older hypogonadal men with unexplained anemia stimulates erythropoiesis', 'They were classified as having unexplained (58) or iron deficiency anemia (37', 'hypogonadal older men with unexplained or iron-deficiency anemia', 'Older Men with Unexplained or Iron-Deficiency Anemia', 'hypogonadal men', 'Twelve academic medical centers', '95 hypogonadal men (testosterone <275 ng/mL) ≥65 years with anemia (hemoglobin <12.7 g/dL']","['Testosterone-Mediated Erythropoiesis', 'testosterone', 'Testosterone replacement', 'Testosterone or placebo gel', 'placebo']","['hemoglobin', 'Markers of iron metabolism', 'unexplained anemia', 'hepcidin']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",95.0,0.520846,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Artz', 'Affiliation': 'City of Hope, Department of Hematology and Hematopoietic Cell Transplantation, Duarte, California.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke University Medical Center, Center for the Study of Aging, Durham, North Carolina.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa521']
2977,32795983,Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews.,"BACKGROUND


Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities.
OBJECTIVE


In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants' antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained.
METHODS


In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group.
RESULTS


Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants' perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken).
CONCLUSIONS


The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants' daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention's mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596.",2020,There were no significant differences between groups in pre-post changes in survey responses.,"['adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications', '34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis', 'Adolescents and Young Adults with Chronic Kidney Disease']","['Text Messaging Adherence Intervention', 'Reminder+COM-B Message intervention group', 'Mobile health interventions', 'Reminder+COM-B Message intervention']","['daily adherence', 'time interaction', 'rate of change in daily adherence', 'desire to take medicine', 'daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.177456,There were no significant differences between groups in pre-post changes in survey responses.,"[{'ForeName': 'Cyd', 'Initials': 'C', 'LastName': 'Eaton', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Comer', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Cozumel', 'Initials': 'C', 'LastName': 'Pruette', 'Affiliation': 'Division of Pediatric Nephrology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Psoter', 'Affiliation': 'Division of General Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Riekert', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}]",Journal of medical Internet research,['10.2196/19861']
2978,32795986,Comparing Methods of Recruiting Spanish-Preferring Smokers in the United States: Findings from a Randomized Controlled Trial.,"BACKGROUND


There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials.
OBJECTIVE


Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost.
METHODS


Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307).
RESULTS


Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001). In addition, a greater percentage of individuals were employed (P<.001) and foreign born (P=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (P<.001) and a greater percentage of individuals were of Central American (P=.02), South American (P=.01), and Cuban (P<.001) origin.
CONCLUSIONS


Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers.",2020,Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001).,"['Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001', 'participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001', 'Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417']",[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],,0.183879,Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001).,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina-Ramirez', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Calixte-Civil', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Martinez', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Byrne', 'Affiliation': 'Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}]",Journal of medical Internet research,['10.2196/19389']
2979,32800511,Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.,"OBJECTIVES


This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND


In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS


PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS


At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS


In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","['patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril', 'Patients', '881 patients stabilized during hospitalization for ADHF']","['valsartan', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan 97/103\xa0mg twice daily, or enalapril', 'sacubitril/valsartan versus enalapril']","['Efficacy and Safety', 'cardiovascular death or rehospitalization for heart failure', 'NT-proBNP', 'efficacy and safety', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",881.0,0.206586,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dberg1@bwh.harvard.edu.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Pinney', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.008']
2980,32811738,"A single one-minute, comfortable paced, stair-climbing bout reduces postprandial glucose following a mixed meal.","BACKGROUND AND AIMS


Postprandial blood glucose (PBG) is an independent predictor of disease and mortality risk. To date, the shortest, single, moderate-intensity exercise intervention to reduce PBG is a 1 min bout of stair stepping during an oral glucose tolerance test. Whether this effect translates to real meal consumption is unknown.
METHODS AND RESULTS


Subjects (N = 30) participated in a randomized controlled crossover trial performing 0 min (seated control), 1 min, 3 min or 10 min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits. Compared to control, all SCD reduced PBG at least one timepoint: at 30-min the 3 min (-10.8 (-18.7 to -2.8) mg/dL, p = 0.010) and 10 min (-36.3 (-46.4 to -26.3) mg/dL), p < .001), and at 45-min the 1 min (-7.3 (-13.9 to -0.7) mg/dL, p = 0.030, 3 min (-8.7 (-13.9 to -3.6) mg/dL, p = 0.002 and 10 min SCD (-12.2 (-18.2 to -6.1)mg/dL, p < 0.000) reduced PBG. The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005) SCD. All SCD were rated by subjects as very light to light intensity.
CONCLUSIONS


Single, subjectively ""light"" intensity stair climbing and descending bouts as short as 1 min in duration attenuate the postprandial glucose response in normal weight individuals following consumption of a mixed meal. More pronounced effects require longer bouts in a dose-dependent manner.",2020,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)",['Subjects (N\xa0=\xa030'],"['0 min (seated control), 1\xa0min, 3\xa0min or 10\xa0min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits']","['Postprandial blood glucose (PBG', 'SCD', 'SCD reduced PBG', 'PBG', 'postprandial glucose', 'area under the curve (AUC) for PBG', 'incremental AUC (iAUC']",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0429009,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA. Electronic address: Jmoore714@gmail.com.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Salmons', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Vinoskey', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Kressler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.020']
2981,32811740,Self-management education may improve blood pressure in people with type 2 diabetes. A randomized controlled clinical trial.,"BACKGROUND AND AIMS


Diabetes is a suitable model to evaluate intervention programmes aimed at chronic diseases, because of its well-defined and measurable process and outcome indicators. In this study, we aimed at investigating the effects of group based self-management education on clinical and psychological variables in type 2 diabetes.
METHODS AND RESULTS


Four-year randomized controlled clinical trial (ISRCTN14558376) comparing Group Care and traditional one-to-one care. Clinical and psychological variables were monitored at baseline, 2 and 4 years. Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls. Prescription of lipid-lowering and anti-hypertensive agents did not change among the patients on Group Care, whereas anti-hypertensives were stepped up among Controls without improving their blood pressure. Multivariable analysis suggests that blood pressure improvement among patients on Group Care was independent of BMI, duration of diabetes and antihypertensive medication, suggesting a direct effect of education, presumably by increasing adherence. The ""Powerful Others"" dimension of the Locus of Control worsened and fear of complications decreased among Controls.
CONCLUSIONS


The results confirm that a multidisciplinary structured group educational approach improves blood pressure, presumably through better adherence to healthy lifestyle and medication, in people with type 2 diabetes.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN14558376.",2020,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","['type 2 diabetes', 'people with type 2 diabetes']","['lipid-lowering and anti-hypertensive agents', 'Self-management education', 'group based self-management education', 'Group Care and traditional one-to-one care']","['fear of complications', 'blood pressure', 'blood pressure improvement', 'body weight, BMI and HbA1c, systolic and diastolic blood pressure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0581567', 'cui_str': 'One to one care'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.059892,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Trento', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy. Electronic address: marina.trento@unito.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fornengo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Amione', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Salassa', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barutta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Gruden', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Mazzeo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Merlo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chiesa', 'Affiliation': 'Links Foundation, Polytechnic University of Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Charrier', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Porta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.023']
2982,32815759,Long-term durability of immunogenicity induced by standard and triple-dose hepatitis B vaccine in patients receiving methadone maintenance treatment.,"OBJECTIVES


We explored the long-term immunogenicity induced by 60 μg and 20 μg hepatitis B vaccines among patients receiving methadone maintenance treatment (MMT).
METHODS


In initial study, a randomized controlled trial was conducted, in which patients receiving MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines at months 0, 1, and 6. In this study, the responders at month 7 were followed-up at months 18, 30, and 42 to estimate long-term immunogenicity.
RESULTS


The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42. Vaccine-induced responses in 75% of patients were observed for 14.2 months in the IM20 group and for 20.0 months in the IM60 group, and differences between these two groups were non-significant ( P  > 0.05).
CONCLUSION


The three-dose 20 µg and 60 µg hepatitis B vaccines showed similar rapid hepatitis B surface antibody decreases.  Abbreviations : HBV, hepatitis B virus; MMT, methadone maintenance treatment; HCC, hepatocellular carcinoma; HBsAg, hepatitis B surface antigen; anti-HBs, hepatitis B surface antibody; HR, hazard ratio; CI, confidence interval; IQR, interquartile range; GEE, generalized estimated equation.",2020,"The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42.","['patients receiving methadone maintenance treatment (MMT', 'patients receiving methadone maintenance treatment']","['MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines', 'standard and triple-dose hepatitis B vaccine']","['Vaccine-induced responses', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.0397442,"The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42.","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Yuanting', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Linying', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Methadone Maintenance Treatment Clinic, Nanning Red Cross Hospital , Nanning, Guangxi, PR China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yale School of Public Health , New Haven, CT, USA.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Chinese Preventive Medicine Association , Beijing, PR China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China.'}]",Expert review of vaccines,['10.1080/14760584.2020.1813577']
2983,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
2984,32829060,The role of endogenous Antisecretory Factor (AF) in the treatment of Ménière's Disease: A two-year follow-up study. Preliminary results.,"PURPOSE


To evaluate the effects of increased endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC) in a sample of patients with defined unilateral Meniere's disease (MD), compared to the results of a treatment protocol of intravenous glycerol and dexamethasone.
MATERIALS AND METHODS


Twenty-six patients with unilateral MD were divided in 2 groups and treated with SPC and with intravenous glycerol and dexamethasone for 24 months. Audio-vestibular evaluation was performed before (T0) and every six months. The number of vertigo spells were evaluated before and after therapy and the Efficacy Index (EI) was calculated. Questionnaires for hearing loss, tinnitus and quality of life were administered.
RESULTS


EI decreased in the SPC group after 18 (T18) (p = .0017) and 24 (T24) months of therapy (p = .0111). There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131). No significant differences were found between the two groups at T0 (p = .4723), while a significant difference was found at T24 (p = .0027). Quality of life showed a significant improvement in daily activities in the SPC group (p = .0033) compared to the infusion therapy group. No statistically significant changes in PTA thresholds were found in both groups between T0 and T24.
CONCLUSION


The preliminary results of our study show a significant reduction of vertigo spells and a positive effect on tinnitus severity and on quality of life in patients with unilateral MD treated with SPC and when compared to patients treated with intravenous glycerol and dexamethasone. No effects on hearing thresholds were noted in both groups.",2020,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"['Twenty-six patients with unilateral MD', ""Ménière's Disease"", 'patients with unilateral MD treated with', ""patients with defined unilateral Meniere's disease (MD""]","['SPC and with intravenous glycerol and dexamethasone', 'endogenous Antisecretory Factor (AF', 'glycerol and dexamethasone', 'intravenous glycerol and dexamethasone', 'SPC', 'endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC']","['Efficacy Index (EI', 'number of vertigo spells', 'daily activities', 'tinnitus severity and on quality of life', 'hearing thresholds', 'hearing loss, tinnitus and quality of life', 'Quality of life', 'vertigo spells', 'PTA thresholds', 'tinnitus score']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0025281', 'cui_str': ""Ménière's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0052093', 'cui_str': 'antisecretory factor'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0201493,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Viola', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Pisani', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Scarpa', 'Affiliation': 'Department of Medicine and Surgery, University of Salerno, Salerno, Italy. Electronic address: alfonsoscarpa@yahoo.it.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cassandro', 'Affiliation': 'Surgical Sciences Department, University of Turin, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Laria', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit of Audiology, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Aragona', 'Affiliation': 'Otolaryngology, A.O.U. Ospedali Riuniti, Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ciriolo', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Spadera', 'Affiliation': 'Otolaryngology, San Leonardo Hospital, Castellammare di Stabia, Napoli, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavaliere', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Iengo', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Chiarella', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102673']
2985,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2021,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
2986,32799042,Continuous positive airway pressure effectively ameliorates arrhythmias in patients with obstructive sleep apnea-hypopnea via counteracting the inflammation.,"INTRODUCTION


This work is aimed at evaluating the therapeutic effect of continuous positive airway pressure (CPAP) in treatment of patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) combined with arrhythmias as well as clarifying the possible mechanism underpinning such an intervention.
METHODS


Through exclusions, a total of 108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work. A computerized permuted block design with varying block stratification and size according to age, sex, AHI and type of arrhythmia was used to randomize 108 patients to CPAP versus sham CPAP for a period of 12-week. All were subjected to unchanged pharmacological anti-arrhythmia therapy combined with CPAP. Before and after CPAP treatment, the improvement of various arrhythmias was compared between the CPAP group and the sham-CPAP group. The levels of CRP, IL-6 and TNF-ɑ were measured simultaneously.
RESULTS


During follow-up, the mean (±SD) CPAP pressure used in the CPAP group was 12.3 (±3.1) cm H2O. The use of CPAP and sham CPAP was on average of 5.2 ± 0.56 and 5.1 ± 0.63 h/night, respectively. After 12 weeks of CPAP therapy, the AHI was significantly decreased and the lowest blood oxygen saturation was notably elevated in the CPAP group compared to the sham-CPAP group, P < 0.05. The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS. The level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) was significantly lower in the CPAP group than in the sham-CPAP group (P < 0.05). Pearson correlation analysis showed that the reduction in the incidence of total arrhythmias was positively correlated with the decrease of CRP, IL-6 and TNF-ɑ levels, respectively.
CONCLUSION


Findings from this work suggest that proper use of CPAP significantly benefits to OSAHS patients combined with arrhythmias, possibly via counteracting the inflammation.",2020,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","['patients with obstructive sleep apnea-hypopnea via counteracting the inflammation', '108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work', 'patients with obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with OSAHS']","['CPAP versus sham CPAP', 'CPAP', 'continuous positive airway pressure (CPAP', 'pharmacological anti-arrhythmia therapy combined with CPAP', 'Continuous positive airway pressure', 'CPAP and sham CPAP']","['mean (±SD) CPAP pressure', 'incidence of total arrhythmias', 'lowest blood oxygen saturation', 'improvement of various arrhythmias', 'CRP, IL-6 and TNF-ɑ levels', 'level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', 'incidence of all types of arrhythmia', 'levels of CRP, IL-6 and TNF-ɑ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",108.0,0.024615,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","[{'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 250021, PR China. Electronic address: zg000507@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102655']
2987,32805050,Processing Apples to Puree or Juice Speeds Gastric Emptying and Reduces Postprandial Intestinal Volumes and Satiety in Healthy Adults.,"BACKGROUND


Whole apples produce greater satiety than processed apples, but the underlying mechanisms remain unclear.
OBJECTIVE


Our aim was to assess the intragastric processing of apple preparations and the associated small and large bowel contents using MRI.
METHODS


An open label, 3-way crossover, randomized, controlled trial. Eighteen healthy adults (mean ± SD age, 25 ± 4 y; BMI, 22.7 ± 3.5 kg/m2) underwent serial MRI scans on 3 occasions separated by 7 d, after consumption of isocaloric (178 kcal) portions of either whole apples, apple puree, or apple juice. Gastric emptying, small bowel water content (SBWC; primary endpoint), were measured at baseline and at 45 min intervals (0-270 min) postmeal ingestion. Fullness and satiety were also assessed at each time point. Treatment effects between groups were analyzed using ANOVA.
RESULTS


Gastric emptying half-time (GE t50) was greater (P < 0.0001) after participants consumed whole apple (mean ± SEM), 65 (3.3) min compared with when they consumed apple puree (41 [2.8] min) or apple juice (38 [2.9] min), times that did not differ. Postprandial area under the curve (AUC) (135-270 min) SBWC was also greater for whole apples than puree (P = 0.025) and juice (P = 0.0004) but juice and puree did not differ. AUC for fullness and satiety (0-270 min) postingestion was also greater (P = 0.002 and 0.004, respectively) for whole apple compared with juice but juice and puree did not differ.
CONCLUSIONS


Gastric emptying is slower after whole apple consumption causing a greater sensation of fullness and satiety than puree or juice in healthy adults. Whole apples increased small bowel and colonic contents during the later phase of the study which may be relevant for subsequent food consumption.This study was registered at clinicaltrials.gov as NCT03714464.",2020,SBWC was also greater for whole apples than puree (P = 0.025) and juice (P = 0.0004) but juice and puree did not differ.,"['Eighteen healthy adults (mean\xa0±\xa0SD age, 25\xa0±\xa04\xa0y; BMI, 22.7\xa0±\xa03.5 kg/m2) underwent', 'Healthy Adults', 'healthy adults']","['MRI', 'serial MRI scans on 3 occasions separated by 7 d, after consumption of isocaloric (178 kcal) portions of either whole apples, apple puree, or apple juice']","['Postprandial Intestinal Volumes and Satiety', 'Gastric emptying half-time (GE t50', 'Postprandial area under the curve (AUC', 'SBWC', 'Gastric emptying, small bowel water content (SBWC', 'sensation of fullness and satiety', 'fullness and satiety', 'small bowel and colonic contents', 'Fullness and satiety']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0227363', 'cui_str': 'Colonic contents'}]",18.0,0.164656,SBWC was also greater for whole apples than puree (P = 0.025) and juice (P = 0.0004) but juice and puree did not differ.,"[{'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Krishnasamy', 'Affiliation': 'Faculty of Health Sciences, Universiti Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia.'}, {'ForeName': 'Miranda Clare Elizabeth', 'Initials': 'MCE', 'LastName': 'Lomer', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'National Institute of Health Research, Nottingham Biomedical Research Centre (BRC) at Nottingham University Hospitals National Health Service Trust and University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Caroline Louise', 'Initials': 'CL', 'LastName': 'Hoad', 'Affiliation': 'National Institute of Health Research, Nottingham Biomedical Research Centre (BRC) at Nottingham University Hospitals National Health Service Trust and University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Susan Elizabeth', 'Initials': 'SE', 'LastName': 'Pritchard', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Penny Ann', 'Initials': 'PA', 'LastName': 'Gowland', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Robin Charles', 'Initials': 'RC', 'LastName': 'Spiller', 'Affiliation': 'National Institute of Health Research, Nottingham Biomedical Research Centre (BRC) at Nottingham University Hospitals National Health Service Trust and University of Nottingham, Nottingham, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa191']
2988,32810553,Hyperprogressive disease during PD-1 blockade in patients with advanced hepatocellular carcinoma.,"BACKGROUND & AIMS


Programmed cell death-1 (PD-1) inhibitor treatment can cause hyperprogressive disease (HPD), but the incidence, outcome, and predictive factors of HPD are unknown in patients with hepatocellular carcinoma (HCC). Herein, we assessed the existence and factors predictive of HPD in patients with advanced HCC treated with nivolumab.
METHODS


We enrolled 189 patients with advanced HCC treated with nivolumab. Occurrence of HPD was investigated using tumour growth dynamics based on tumour growth kinetics (TGK) and tumour growth rate (TGR) before and after treatment, or time to treatment failure. We additionally analysed patients treated with regorafenib (n = 95) or best supportive care (BSC)/placebo (n = 103) after progression on sorafenib to compare tumour growth dynamics.
RESULTS


Flare-up of tumour growth was observed in a fraction of patients upon PD-1 blockade, indicating the occurrence of HPD. Based on distinct patterns of disease progression exclusively observed in the nivolumab-treated cohort, but not in the regorafenib- or BSC/placebo-treated cohorts, 4-fold increases in TGK and TGR ratios as well as a 40% increase in TGR were the cut-off values used to define HPD; 12.7% of the patients (24/189) treated with nivolumab met all these criteria. Patients with HPD had worse progression-free survival (hazard ratio [HR] 2.194; 95% CI 1.214-3.964) and overall survival (HR 2.238; 95% CI 1.233-4.062) compared to patients with progressive disease without HPD. More than 90% of patients with HPD missed the opportunity for subsequent treatment because of rapid clinical deterioration. An elevated neutrophil-to-lymphocyte ratio (>4.125) was associated with HPD and an inferior survival rate.
CONCLUSIONS


HPD occurs in a fraction of patients with HCC who receive PD-1 inhibitor treatment. Analyses of the baseline immune profile and on-treatment tumour growth dynamics could enable optimal patient selection and earlier identification of HPD.
LAY SUMMARY


Hyperprogressive disease is an unexpected response pattern observed in patients treated with an immune checkpoint inhibitor. This study revealed that hyperprogressive disease occurs in a fraction of patients with advanced hepatocellular carcinoma treated with an anti-PD-1 antibody, providing evidence to encourage careful monitoring of patients to prevent clinical deterioration induced by PD-1 blockade.",2020,"An elevated neutrophil-to-lymphocyte ratio (> 4.125) was associated with HPD and an inferior survival rate.
","['Advanced HCC patients treated with nivolumab (n=189) were enrolled', 'advanced HCC patients treated with nivolumab', 'hepatocellular carcinoma (HCC) patients treated with PD-1 blockade', 'patients with advanced hepatocellular carcinoma']","['regorafenib (n=95) or best supportive care (BSC)/placebo (n=103) after progression with sorafenib', 'PD-1 blockade']","['progression-free survival', 'overall survival', 'HPD and an inferior survival rate', 'TGR', 'TGK and TGR ratios', 'tumour growth kinetics (TGK) and tumour growth rate (TGR', 'elevated neutrophil-to-lymphocyte ratio']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0151683', 'cui_str': 'Neutrophilia'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}]",189.0,0.141503,"An elevated neutrophil-to-lymphocyte ratio (> 4.125) was associated with HPD and an inferior survival rate.
","[{'ForeName': 'Chang Gon', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea; Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Medical Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Sang Eun', 'Initials': 'SE', 'LastName': 'Yoon', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea; Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seong Jin', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Beodeul', 'Initials': 'B', 'LastName': 'Kang', 'Affiliation': 'Medical Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su-Hyung', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Shin', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Yeun-Yoon', 'Initials': 'YY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae Jung', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hong Jae', 'Initials': 'HJ', 'LastName': 'Chon', 'Affiliation': 'Medical Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea. Electronic address: minidoctor@cha.ac.kr.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea. Electronic address: choihj@yuhs.ac.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: hoylim@skku.edu.'}]",Journal of hepatology,['10.1016/j.jhep.2020.08.010']
2989,32810697,A comparison of young children's spatiotemporal measures of walking and running in three common types of footwear compared to bare feet.,"BACKGROUND


Clinicians and footwear manufacturers often advise young children to wear soft-soled footwear when they are first learning to walk. There is limited evidence as to why this advice is given, and if soft-soled shoes are as close to barefoot as thought.
RESEARCH QUESTION


What are the differences in spatiotemporal measures of gait during walking and running in three common types of children's footwear with a soft-soled compared to barefoot in young children?
METHODS


The study used a quasi-experimental design, with the condition order randomised using a Latin square sequence. Forty-seven children were recruited (2 - 4 years). Participants walked or ran the length of a GAITrite mat in a randomized order for barefoot and soft-soled sneaker, boot and sandal conditions. Linear regression analyses were used to investigate the main effect of each soft-soled footwear compared to bare feet in the different gait parameters.
RESULTS


For walking and running trials, cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition. While wearing sneakers and sandals increased the stance percentage for walking and running trials, compared to barefoot, this difference was only apparent during the running trial for the boots. Likewise, although double support time increased for both the boots and sneakers in walking and running, compared to barefoot, this difference was only observed in the sandals during walking.
SIGNIFICANCE


This research found that various types of soft-soled footwear impacted gait compared to the barefoot condition, with some differences seen between walking and running trials. These findings challenge the assumption that soft-soled footwear facilitate a similar gait to barefoot walking and running, although the clinical significance of these differences is unknown.",2020,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.",['Forty-seven children were recruited (2 - 4\u202fyears'],[],['step time and stride length'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",47.0,0.0330217,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cranage', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia. Electronic address: simone.cranage@monash.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Perraton', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Bowles', 'Affiliation': 'Department of Paramedicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cylie', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.147']
2990,32812844,A Yoga-Based Program Decreases Physician Burnout in Neonatologists and Obstetricians at an Academic Medical Center.,"BACKGROUND


Nearly half of U.S. pediatricians have symptoms of burnout. This pilot study examined the feasibility of a 6-week yoga-based program (RISE) for neonatologists and obstetricians at Brigham and Women's Hospital and studied the effects on burnout, professional fulfillment, and psychological health.
METHODS


Participants were recruited via email to participate either in both program and research study, or exclusively the program. RISE was delivered 1 hour/week during the workday for 6 consecutive weeks either in-person or remotely; 18 physicians participated, 12 completed post-program, and 11 completed 2-month follow-up. The questionnaires assessed burnout and measures of psychological health, professional fulfillment, work exhaustion, interpersonal disengagement/burnout (PFI), mindfulness (FFMQ), perceived stress (PSS), positive/negative affect (PANAS), resilience (RS), anxiety/depression/sleep disturbances (PROMIS), at baseline, post-program, and 2 months after RISE.
FINDINGS


Average attendance in-person was 2.8 sessions and remotely 1.4 sessions (4.2/6 sessions). Participants demonstrating total burnout reduced from 50.0% at baseline to 9.1% post-program. Participants demonstrating professional fulfillment were 8.3% at baseline and 27.3% post-program. Paired samples  t -tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline ( N  = 12, all  p s < .05). At 2-month follow-up, statistically significant improvements in interpersonal disengagement, resilience, and mindfulness ( N  = 11, all  p s < .05) compared with baseline were reported.
CONCLUSIONS/APPLICATION TO PRACTICE


RISE is feasible within a workday and may address burnout and other psychological health measures in physicians with effects potentially sustainable over 2 months. Occupational health practitioners in health care should consider this type of intervention for their workers.",2020,"t -tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline ( N  = 12,","['Occupational health practitioners in health care', 'in Neonatologists and Obstetricians at an Academic Medical Center', 'Participants were recruited via email to participate either in both program and research study, or exclusively the program']","['6-week yoga-based program (RISE', 'Yoga-Based Program Decreases Physician Burnout']","['questionnaires assessed burnout and measures of psychological health, professional fulfillment, work exhaustion, interpersonal disengagement/burnout (PFI), mindfulness (FFMQ), perceived stress (PSS), positive/negative affect (PANAS), resilience (RS), anxiety/depression/sleep disturbances (PROMIS', 'professional fulfillment', 'burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression', 'interpersonal disengagement, resilience, and mindfulness', 'total burnout']","[{'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0334898', 'cui_str': 'Neonatologist'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",18.0,0.0183,"t -tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline ( N  = 12,","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Scheid', 'Affiliation': ""Brigham and Women's Hospital.""}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Dyer', 'Affiliation': 'Kripalu Center for Yoga & Health.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'Kripalu Center for Yoga & Health.'}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Brigham and Women's Hospital.""}]",Workplace health & safety,['10.1177/2165079920930720']
2991,32814120,Development and preliminary testing of a technology-enhanced intervention to improve energy intake regulation in children.,"Interventions designed to improve children's self-regulation of energy intake have yielded mixed results. We tested the efficacy of a technology-enhanced intervention designed to teach children to eat in response to internal hunger and fullness cues. Thirty-two children (mean age 4.9 ± 0.8 y) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions, each scheduled approximately 1 week apart. The intervention was conducted across weeks 4-7 in small groups focused on teaching children how food travels through the body and how to respond to hunger and fullness signals. Children's short-term energy compensation, a measure of intake regulation, was collected at baseline and follow-up using a preloading protocol. Twenty-five minutes prior to receiving a standardized test meal, children consumed a low-energy (3 kcal) or high-energy (150 kcal) preload beverage, presented in random order at baseline and follow-up. Knowledge of intervention concepts was also assessed at baseline and follow-up. Linear mixed models were used to examine changes in short-term energy compensation and knowledge from baseline to follow-up. Knowledge related to the intervention improved from baseline to follow-up (3.5 ± 0.3 to 7.0 ± 0.3 correct responses out of a possible 10; P < 0.001). Children's energy compensation also improved from baseline to follow-up, as evidenced by a time-by-preload condition interaction (P = 0.02). However, this improvement was driven by boys who increased the adjustment for beverage energy content from baseline to follow-up (P = 0.04). Girls showed no change in energy compensation with the intervention (P = 0.58). The overall increase in knowledge, paired with the improvement in energy compensation in boys, suggests that this technology-enhanced intervention may be efficacious for some children. Further research is needed to determine whether boys and girls will benefit from different, personalized intervention strategies for obesity prevention.",2020,Girls showed no change in energy compensation with the intervention (P = 0.58).,"['Thirty-two children (mean age 4.9\u202f±\u202f0.8\u202fy) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions', 'children']","['technology-enhanced intervention', 'standardized test meal, children consumed a low-energy (3\u202fkcal) or high-energy (150\u202fkcal) preload beverage']","['energy compensation', ""Children's energy compensation""]","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",32.0,0.0189846,Girls showed no change in energy compensation with the intervention (P = 0.58).,"[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 226 Henderson Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'The Pennsylvania State University, Center for Childhood Obesity Research and Department of Nutritional Sciences. 129 Noll Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Department of Pediatrics. 12631 East 17th Avenue, Mail Stop F-561, Academic Office Building, Room 2609; Aurora, CO, 80045, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'The Pennsylvania State University, Departments of Nutritional Sciences and Food Science. 321 Chandlee Laboratory, University Park, PA, 16802, USA. Electronic address: klk37@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.104830']
2992,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
2993,32800391,The effectiveness of oropharyngeal exercises compared to inspiratory muscle training in obstructive sleep apnea: A randomized controlled trial.,"BACKGROUND


Inspiratory muscle training (IMT) and oropharyngeal exercises (OE) have different advantages and disadvantages and a comparison of these modalities has been recommended. The aim of this study was to compare the effects of IMT and OE on important outcomes for patients with OSAS.
METHODS


This was a randomized controlled clinical trial. Forty-one clinically stable OSAS patients not receiving CPAP therapy were randomly divided into three groups. Patients in the IMT group (n = 15) trained with a threshold loading device 7 days/week for 12 weeks. Patients in the OE group (n = 14) practiced exercises 5 days/week for 12 weeks. Twelve patients served as control group. Apnea-hypopnea index (AHI), respiratory muscle strength, snoring severity and frequency (Berlin Questionnaire), daytime sleepiness (Epworth Sleepiness Scale; ESS), sleep quality (Pittsburg Sleep Quality Index; PSQI), impact of sleepiness on daily life (Functional Outcomes of Sleep Questionnaire; FOSQ), and fatigue severity (Fatigue Severity Scale; FSS) were evaluated before and after the interventions.
RESULTS


AHI and sleep efficiency did not change significantly in any of the groups. Significant decreases in snoring severity and frequency, FSS and PSQI total scores were found in the IMT and OE groups after the treatments (p < 0.05). There was a significant reduction in neck and waist circumference and significant improvement in respiratory muscle strength (MIP and MEP) in IMT group compared to control group (p < 0.05). The%MEPpred value and FOSQ total score significantly increased and ESS score reduced after the treatment in OE group compared to control group (p < 0.05).
CONCLUSIONS


Our results indicate that both OE and IMT rehabilitation interventions are applicable in rehabilitation programs for OSAS patients who do not accept CPAP therapy. Our findings could lead to increase these methods' use among rehabilitation professionals and decrease in cost of CPAP treatment in OSAS.",2020,"Significant decreases in snoring severity and frequency, FSS and PSQI total scores were found in the IMT and OE groups after the treatments (p < 0.05).","['patients with OSAS', 'OSAS patients who do not accept CPAP therapy', 'obstructive sleep apnea', 'Forty-one clinically stable OSAS patients not receiving CPAP therapy', 'Twelve patients served as control group']","['Inspiratory muscle training (IMT) and oropharyngeal exercises (OE', 'OE and IMT rehabilitation interventions', 'oropharyngeal exercises', 'IMT and OE', 'inspiratory muscle training', 'IMT']","['FOSQ total score', 'Apnea-hypopnea index (AHI), respiratory muscle strength, snoring severity and frequency (Berlin Questionnaire), daytime sleepiness (Epworth Sleepiness Scale; ESS), sleep quality (Pittsburg Sleep Quality Index; PSQI), impact of sleepiness on daily life (Functional Outcomes of Sleep Questionnaire; FOSQ), and fatigue severity (Fatigue Severity Scale; FSS', 'ESS score', 'neck and waist circumference', 'snoring severity and frequency, FSS and PSQI total scores', 'respiratory muscle strength (MIP and MEP', 'AHI and sleep efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",41.0,0.0185838,"Significant decreases in snoring severity and frequency, FSS and PSQI total scores were found in the IMT and OE groups after the treatments (p < 0.05).","[{'ForeName': 'Nurel', 'Initials': 'N', 'LastName': 'Erturk', 'Affiliation': 'Cardiopulmonary Rehabilitation Unit, University of Health Sciences, Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital, Trabzon, Turkey. Electronic address: nrlbllr@gmail.com.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Calik-Kutukcu', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hulya', 'Initials': 'H', 'LastName': 'Arikan', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Atilim University, Ankara, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physiotherapy and Rehabilitation, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Inal-Ince', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Caliskan', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Saglam', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Naciye', 'Initials': 'N', 'LastName': 'Vardar-Yagli', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hikmet', 'Initials': 'H', 'LastName': 'Firat', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Celik', 'Affiliation': 'Department of Chest Medicine and Sleep Center, University of Health Sciences, Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital, Trabzon, Turkey.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Yuce-Ege', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sadik', 'Initials': 'S', 'LastName': 'Ardic', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.07.014']
2994,32807539,Medication Education for Dosing Safety: A Randomized Controlled Trial.,"STUDY OBJECTIVE


This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians.
METHODS


We performed a randomized controlled trial in the ED of parents and guardians of children 90 days to 11.9 years of age who were discharged with acetaminophen or ibuprofen, or both. Families were randomized to standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing. Participants were called 48 to 72 hours and 5 to 7 days after ED discharge to assess understanding of correct dosing. The primary outcome was defined as parent or guardian report of safe dosing at the time of first follow-up call. Our primary hypothesis was that the intervention would decrease the rate of error from 30% to 10% at 48- to 72-hour follow-up.
RESULTS


We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention. Among those participants receiving the intervention, 25 of 35 (71%) were able to identify a safe dose for their child at the time of the first call compared with 28 of 62 (45%) of those in the control arm. The difference in proportions was 26% (95% confidence interval [CI] 7% to 46%). There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
CONCLUSIONS


A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours.",2020,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","['by parents or guardians', 'We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention', 'parents and guardians of children 90 days to 11.9 years of age who were discharged with', ' or both']","['acetaminophen or ibuprofen', 'standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing', 'liquid acetaminophen and ibuprofen']","['health literacy and language', 'rate of error', 'reporting safe dosing', 'parent or guardian report of safe dosing at the time of first follow-up call']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",149.0,0.136961,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Naureckas Li', 'Affiliation': ""Division of Pediatric Infectious Diseases, Boston Children's Hospital, Boston, MA. Electronic address: caitlin.li@childrens.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faridi', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Espinola', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Bryan D', 'Initials': 'BD', 'LastName': 'Hayes', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA; Department of Pharmacy, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Samuels-Kalow', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.07.007']
2995,32807615,"Early complications in delayed breast reconstruction: A prospective, randomized study comparing different reconstructive methods in radiated and non-radiated patients.","BACKGROUND


There is little high-quality scientific evidence identifying the best and safest methods for delayed breast reconstruction, with most previous studies retrospective in nature. The primary aim was to compare early complication rates for two different breast-reconstructive methods in radiated and non-radiated patients, using a validated scale. The secondary aim was to identify predictors for complications.
MATERIALS AND METHODS


This study represents a clinical, randomized, prospective trial (ClinicalTrials.Gov identifier: NCT03963427), where the patients were divided into two study arms: non-radiated and radiated. In the non-radiated arm, patients were randomized to a one-stage lateral thoracodorsal flap with an implant or two-stage expander reconstruction. In the radiated arm, patients were randomized to a latissimus dorsi reconstruction combined with an implant or deep inferior epigastric artery perforator (DIEP) reconstruction. All adverse events were classified according to Clavien-Dindo and summarization of overall morbidity was performed by calculating the Comprehensive Complication Index score. The study was conducted from 2008 to 2020.
RESULTS


The complication frequencies were similar for the two surgical methods within each arm. In the non-radiated arm, risk factors for any complication were any comorbidities, and in the radiated arm, factors were a high body mass index and a contralateral operation.
CONCLUSIONS


The usage of the Clavien-Dindo scale in reconstructive surgery is feasible, but further validation is needed. In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi. The complication profile of the methods varied.",2020,"In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi.","['2008 to 2020', 'radiated and non-radiated patients', 'delayed breast reconstruction']","['latissimus dorsi reconstruction combined with an implant or deep inferior epigastric artery perforator (DIEP) reconstruction', 'one-stage lateral thoracodorsal flap with an implant or two-stage expander reconstruction']","['early complication rates', 'complication frequencies', 'Comprehensive Complication Index score', 'frequencies of short-term complications']","[{'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0224362', 'cui_str': 'Structure of latissimus dorsi muscle'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0226401', 'cui_str': 'Structure of inferior epigastric artery'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0231243', 'cui_str': 'Early complication'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.0709844,"In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Brorson', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: fredrik.brorson@vgregion.se.'}, {'ForeName': 'Andri', 'Initials': 'A', 'LastName': 'Thorarinsson', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kölby', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hansson', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: emma.hansson.2@gu.se.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.07.010']
2996,32807632,Effects of cognitive behavioral therapy on sleep disturbances and quality of life among adults with type 2 diabetes mellitus: A randomized controlled trial.,"BACKGROUND AND AIMS


Cognitive behavioral therapy (CBT) is recommended as the first-line nonpharmacotherapy for sleep complaints. However, there are no studies that tested CBT for improving sleep quality and increasing quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM). Therefore, this study aims to test the effect of CBT on sleep disturbances and QOL in patients with T2DM.
METHODS AND RESULTS


In total, 187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving CBT with aerobic exercise plus UC, The Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values were collected at baseline, after the 2-month intervention, and 6 months of follow-up. The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up. No difference was found in HbAlc between the two groups (t = -0.47, P = 0.64) after 2-month intervention, while the CBT group had 0.89 units lower HbAlc (95% CI: 0.49-1.28, P < 0.001) than the control group after 6-month follow-up.
CONCLUSION


CBT is effective for sleep disturbances and can also improve sleep quality, increase QOL, and decrease glycemic levels in participants with T2DM.
TRIAL REGISTRATION


Chinese Clinical Trials Registration (Practical study of the appropriate technique for improvement of quality of life of the patients with type 2 diabetes in communities: ChiCTR-IOP-16008045).",2020,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","['187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving', 'adults with type 2 diabetes mellitus', 'participants with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', 'patients with type 2 diabetes in communities']","['Cognitive behavioral therapy (CBT', 'CBT', 'cognitive behavioral therapy', 'CBT with aerobic exercise plus UC']","['glycemic levels', 'quality of life', 'sleep disturbances and QOL', 'PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values', 'quality of life (QOL', 'total DSQLS scores', 'sleep disturbances and quality of life', 'sleep quality, increase QOL', 'sleep quality', 'HbAlc']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",187.0,0.0901047,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 2783369510@qq.com.""}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: dzm1001@126.com.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 11754214@qq.com.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: xzzhangpan@126.com.'}, {'ForeName': 'Guiqiu', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: 1548857561@qq.com.'}, {'ForeName': 'Quanyong', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: quanyongxiang@vip.sina.com.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 610492837@qq.com.""}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: 158694402@qq.com.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Qiao', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: yyand4824@hotmail.com.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: qinyu@jscdc.cn.'}, {'ForeName': 'Peian', 'Initials': 'P', 'LastName': 'Lou', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: lpa82835415@126.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.024']
2997,32812059,"Letter to the editor regarding ""Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial"" by Zheng et al.",,2020,,['elderly patients with proximal femoral fractures'],"['Omega-3 fatty acids', 'placebo']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.398941,,"[{'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Shigemura', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. tshigepon@yahoo.co.jp.'}]",International orthopaedics,['10.1007/s00264-020-04776-7']
2998,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2021,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
2999,32826717,"Intervention and Mechanisms of Alanyl-glutamine for Inflammation, Nutrition, and Enteropathy: A Randomized Controlled Trial.","OBJECTIVE


Determine the minimum dosage of alanyl-glutamine (Ala-Gln) required to improve gut integrity and growth in children at risk of environmental enteropathy (EE).
METHODS


This was a double-blinded randomized placebo-controlled dose-response trial. We enrolled 140 children residing in a low-income community in Fortaleza, Brazil. Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1. We randomized children to 10 days of nutritional supplementation: Ala-Gln at 3 g/day, Ala-Gln at 6 g/day, Ala-Gln at 12 g/day, or an isonitrogenous dose of glycine (Gly) placebo at 12.5 g/day. Our primary outcome was urinary lactulose-mannitol excretion testing. Secondary outcomes were anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy).
RESULTS


Of 140 children, 103 completed 120 days of follow-up (24% dropout). In the group receiving the highest dose of Ala-Gln, we detected a modest improvement in urinary lactulose excretion from 0.19% on day 1 to 0.17% on day 10 (P = 0.05). We observed significant but transient improvements in WHZ at day 10 in 2 Ala-Gln groups, and in WHZ and WAZ in all Ala-Gln groups at day 30. We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose Ala-Gln promotes short-term improvement in gut integrity and ponderal growth in children at risk of EE. Lower doses produced improvements in ponderal growth in the absence of enhanced gut integrity.",2020,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","['140 children residing in a low-income community in Fortaleza, Brazil', 'children at risk of EE', 'Of 140 children, 103 completed 120 days of follow-up (24% dropout', 'children at risk of environmental enteropathy (EE', 'Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1', 'participants receiving Ala-Gln.\nCONCLUSIONS\n\n\nIntermediate dose']","['glycine (Gly) placebo', 'nutritional supplementation: Ala-Gln at 3\u200ag/day, Ala-Gln at 6\u200ag/day, Ala-Gln', 'alanyl-glutamine (Ala-Gln', 'placebo']","['anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy', 'gut integrity and ponderal growth', 'fecal energy and fecal lactoferrin', 'Inflammation, Nutrition, and Enteropathy', 'urinary lactulose-mannitol excretion testing', 'urinary lactulose excretion', 'fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",140.0,0.33091,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Moore', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Quinn', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Maier', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Guedes', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Josiane S', 'Initials': 'JS', 'LastName': 'Quetz', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramprasad', 'Affiliation': 'Department of Internal Medicine, NYU School of Medicine/NYU Langone Medical Center, New York, NY.'}, {'ForeName': 'Gabriela M L', 'Initials': 'GML', 'LastName': 'Lanzarini Lopes', 'Affiliation': 'Department of Emergency Medicine, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, and Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swann', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College, London.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'José Q', 'Initials': 'JQ', 'LastName': 'Filho', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Junior', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Havt', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Noelia L', 'Initials': 'NL', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Disease and International Health, Department of Medicine, Center for Global Health, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Aldo A M', 'Initials': 'AAM', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002834']
3000,32839029,Effects of Dexmedetomidine and ACE Genotype on Cardiovascular Response During the Decannulation Period of General Anesthesia in Patients With Essential Hypertension.,"PURPOSE


This study investigated the effects of dexmedetomidine on cardiovascular response during the decannulation period of general anesthesia in patients with different genotypes of angiotensin-converting enzyme (ACE) and essential hypertension.
METHODS


The present study enrolled patients with essential hypertension and American Society of Anesthesiologists class II or III who were scheduled to undergo abdominal surgery under general anesthesia. Patients were assigned to 1 of 6 groups according to ACE genotype, as detected by polymerase chain reaction-restriction fragment length polymorphism, as follows: DD; ID; II; and DD, ID, and II each with dexmedetomidine (Dex). Dexmedetomidine was intravenously infused at 0.5 μg/kg/h for 30 min before the end of surgery in groups DD (Dex), ID (Dex), and II(Dex). Anesthesia was induced and maintained by the same anesthetics in all patients. Systolic and diastolic blood pressure, heart rate (HR), ECG, and rate-pressure product were recorded before anesthesia induction; at 30 min before the end of surgery; at the end of surgery; and at 0, 1.5, 5, and 10 min after extubation.
FINDINGS


A total of 210 patients were enrolled (n = 35 per genotype). After extubation, systolic and diastolic blood pressure, HR, and RPP were increased markedly from baseline in groups DD, ID, and II; the increases were greater in groups DD and ID than in group II. No significant changes in blood pressure, HR, or RPP were found, and proper sedative was achieved in groups DD (Dex), ID (Dex), and II(Dex). The prevalences of cardiac arrhythmia were higher in groups DD and ID than in groups II, DD (Dex), ID (Dex), and II(Dex).
IMPLICATIONS


Patients essential hypertension and the ACE D allele had a strong hemodynamic response to tracheal extubation, on which dexmedetomidine was found to have both a prevention and treatment effect.",2020,"No significant changes in blood pressure, HR, or RPP were found, and proper sedative was achieved in groups DD (Dex), ID (Dex), and II(Dex).","['enrolled patients with essential hypertension and American Society of Anesthesiologists class II or III who were scheduled to undergo abdominal surgery under general anesthesia', '210 patients were enrolled (n\xa0=\xa035 per genotype', 'patients with different genotypes of angiotensin-converting enzyme (ACE) and essential hypertension', 'Patients With Essential Hypertension']","['Dexmedetomidine', 'dexmedetomidine (Dex', 'Dexmedetomidine and ACE Genotype', 'dexmedetomidine']","['Cardiovascular Response', 'systolic and diastolic blood pressure, HR, and RPP', 'prevalences of cardiac arrhythmia', 'Systolic and diastolic blood pressure, heart rate (HR), ECG, and rate-pressure product', 'cardiovascular response', 'blood pressure, HR, or RPP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",210.0,0.0247976,"No significant changes in blood pressure, HR, or RPP were found, and proper sedative was achieved in groups DD (Dex), ID (Dex), and II(Dex).","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Wei-Juan', 'Initials': 'WJ', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Wuxi Hospital of Conventional Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China. Electronic address: wangjun19710930@126.com.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Zha', 'Affiliation': ""Department of Anesthesiology, People's Hospital of Lishui, Nanjing, China.""}, {'ForeName': 'Mo-Qin', 'Initials': 'MQ', 'LastName': 'Shao', 'Affiliation': ""Electrocardiography, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Hui-Jun', 'Initials': 'HJ', 'LastName': 'Mu', 'Affiliation': ""Central Laboratory, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.012']
3001,32836188,Comparison of low and high inspiratory oxygen fraction added to lung-protective ventilation on postoperative pulmonary complications after abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative lung-protective ventilation strategy has been recommended to reduce postoperative pulmonary complications (PPCs). However, the role of inspiratory oxygen fraction (FiO 2 ) in this protection remains highly uncertain. We aimed to evaluate the effect of intraoperative low (30%) versus high (80%) FiO 2  in the context of lung-protective ventilation strategy on PPCs in patients undergoing abdominal surgery.
DESIGN


Prospective, two-arm, randomized controlled trial.
SETTING


Tertiary university hospital in China.
PATIENTS


A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study.
INTERVENTION


Patients were randomly assigned to receive either 30% or 80% FiO 2  during the intraoperative period. All patients received volume-controlled mechanical ventilation with lung-protective ventilation approach, which included a tidal volume of 8 ml kg -1  of predicted body weight, a positive end-expiratory pressure level of 6-8 cmH 2 O, and repeated recruitment maneuvers.
MEASUREMENTS


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis. The severity grade of PPCs was measured as a key secondary outcome.
MAIN RESULTS


Two hundred and fifty-one patients completed the trial. PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025). The severity of PPCs within the first 7 days following surgery was attenuated significantly in the low (30%) FiO 2  group (p = 0.001).
CONCLUSIONS


Among patients undergoing abdominal surgery under general anesthesia, an intraoperative lung-protective ventilation strategy with 30% FiO 2  compared with 80% FiO 2  did not reduce the incidence of PPCs. And the use of 30% FiO 2  resulted in less severe pulmonary complications.",2020,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","['patients undergoing abdominal surgery', 'patients undergoing abdominal surgery under general anesthesia', 'Tertiary university hospital in China', 'Two hundred and fifty-one patients completed the trial', 'A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study', 'postoperative pulmonary complications after abdominal surgery']","['volume-controlled mechanical ventilation with lung-protective ventilation approach', 'low and high inspiratory oxygen fraction added to lung-protective ventilation']","['severe pulmonary complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis', 'PPCs', 'severity of PPCs', 'severity grade of PPCs', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.482006,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Yu-Lian', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China. Electronic address: yuhaishan117@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110009']
3002,32844723,First Human Use of RUC-4: A Nonactivating Second-Generation Small-Molecule Platelet Glycoprotein IIb/IIIa (Integrin αIIbβ3) Inhibitor Designed for Subcutaneous Point-of-Care Treatment of ST-Segment-Elevation Myocardial Infarction.,"Background Despite reductions in door-to-balloon times for primary coronary intervention, mortality from ST-segment-elevation myocardial infarction has plateaued. Early pre-primary coronary intervention treatment of ST-segment-elevation myocardial infarction with glycoprotein IIb/IIIa inhibitors improves pre-primary coronary intervention coronary flow, limits infarct size, and improves survival. We report the first human use of a novel glycoprotein IIb/IIIa inhibitor designed for subcutaneous first point-of-care ST-segment-elevation myocardial infarction treatment. Methods and Results Healthy volunteers and patients with stable coronary artery disease receiving aspirin received escalating doses of RUC-4 or placebo in a sentinel-dose, randomized, blinded fashion. Inhibition of platelet aggregation (IPA) to ADP (20 μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments were made through 24 hours and at 7 days. Doses were increased until reaching the biologically effective dose (the dose producing ≥80% IPA within 15 minutes, with return toward baseline within 4 hours). In healthy volunteers, 15 minutes after subcutaneous injection, mean±SD IPA was 6.9%+7.1% after placebo and 71.8%±15.0% at 0.05 mg/kg (n=6) and 84.7%±16.7% at 0.075 mg/kg (n=6) after RUC-4. IPA diminished over 90 to 120 minutes. In patients with coronary artery disease, 15 minutes after subcutaneous injection of placebo or 0.04 mg/kg (n=2), 0.05 mg/kg (n=6), and 0.075 mg/kg (n=18) of RUC-4, IPA was 14.6%±11.7%, 53.6%±17.0%, 76.9%±10.6%, and 88.9%±12.7%, respectively. RUC-4 blood levels correlated with IPA. Aspirin did not affect IPA or RUC-4 blood levels. Platelet counts were stable and no serious adverse events, bleeding, or injection site reactions were observed. Conclusions RUC-4 provides rapid, high-grade, limited-duration platelet inhibition following subcutaneous administration that appears to be safe and well tolerated. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NTC03844191.",2020,"Inhibition of platelet aggregation (IPA) to ADP (20 μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments were made through 24 hours and at 7 days.","['Healthy volunteers and patients with stable coronary artery disease receiving', 'healthy volunteers', 'patients with coronary artery disease']","['glycoprotein IIb/IIIa inhibitors', 'novel glycoprotein IIb/IIIa inhibitor', 'RUC-4 or placebo', 'A Nonactivating Second-Generation Small-Molecule Platelet Glycoprotein IIb/IIIa (Integrin αIIbβ3', 'Aspirin', 'placebo', 'aspirin', 'RUC-4']","['Platelet counts', 'RUC-4 blood levels', 'mean±SD IPA', 'safe and well tolerated', 'Inhibition of platelet aggregation (IPA) to ADP (20\xa0μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments', 'IPA', 'IPA or RUC-4 blood levels', 'serious adverse events, bleeding, or injection site reactions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0061671', 'cui_str': 'ITGA2B protein, human'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0523964', 'cui_str': 'Urea nitrogen renal clearance measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",,0.084962,"Inhibition of platelet aggregation (IPA) to ADP (20 μmol/L), RUC-4 blood levels, laboratory evaluations, and clinical assessments were made through 24 hours and at 7 days.","[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Anthony N', 'Initials': 'AN', 'LastName': 'DeMaria', 'Affiliation': 'UC San Diego Health La Jolla CA.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Bentur', 'Affiliation': 'Allen and Frances Adler Laboratory of Blood and Vascular Biology Rockefeller University New York NY.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Precision for Medicine Carlsbad CA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Seng Yue', 'Affiliation': 'Learn and Confirm Inc. Saint-Laurent Quebec Canada.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Martin', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Midkiff', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Terah', 'Initials': 'T', 'LastName': 'Meek', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Garza', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Boston Clinical Research Institute Newton MA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Coller', 'Affiliation': 'Allen and Frances Adler Laboratory of Blood and Vascular Biology Rockefeller University New York NY.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016552']
3003,32786187,Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia.,"BACKGROUND


Older patients with acute myeloid leukemia (AML) have a dismal prognosis, even after treatment with a hypomethylating agent. Azacitidine added to venetoclax had promising efficacy in a previous phase 1b study.
METHODS


We randomly assigned previously untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to azacitidine plus either venetoclax or placebo. All patients received a standard dose of azacitidine (75 mg per square meter of body-surface area subcutaneously or intravenously on days 1 through 7 every 28-day cycle); venetoclax (target dose, 400 mg) or matching placebo was administered orally, once daily, in 28-day cycles. The primary end point was overall survival.
RESULTS


The intention-to-treat population included 431 patients (286 in the azacitidine-venetoclax group and 145 in the azacitidine-placebo [control] group). The median age was 76 years in both groups (range, 49 to 91). At a median follow-up of 20.5 months, the median overall survival was 14.7 months in the azacitidine-venetoclax group and 9.6 months in the control group (hazard ratio for death, 0.66; 95% confidence interval, 0.52 to 0.85; P<0.001). The incidence of complete remission was higher with azacitidine-venetoclax than with the control regimen (36.7% vs. 17.9%; P<0.001), as was the composite complete remission (complete remission or complete remission with incomplete hematologic recovery) (66.4% vs. 28.3%; P<0.001). Key adverse events included nausea of any grade (in 44% of the patients in the azacitidine-venetoclax group and 35% of those in the control group) and grade 3 or higher thrombocytopenia (in 45% and 38%, respectively), neutropenia (in 42% and 28%), and febrile neutropenia (in 42% and 19%). Infections of any grade occurred in 85% of the patients in the azacitidine-venetoclax group and 67% of those in the control group, and serious adverse events occurred in 83% and 73%, respectively.
CONCLUSIONS


In previously untreated patients who were ineligible for intensive chemotherapy, overall survival was longer and the incidence of remission was higher among patients who received azacitidine plus venetoclax than among those who received azacitidine alone. The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group. (Funded by AbbVie and Genentech; VIALE-A ClinicalTrials.gov number, NCT02993523.).",2020,The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.,"['Previously Untreated Acute Myeloid Leukemia', 'untreated patients with confirmed AML who were ineligible for standard induction therapy because of coexisting conditions, because they were 75 years of age or older, or both to', 'Older patients with acute myeloid leukemia (AML', 'The median age was 76 years in both groups (range, 49 to 91', '431 patients (286 in the azacitidine-venetoclax group and 145 in the']","['azacitidine plus venetoclax', 'azacitidine', 'venetoclax (target dose, 400 mg) or matching placebo', 'Azacitidine', 'venetoclax', 'Azacitidine and Venetoclax', 'azacitidine-venetoclax', 'azacitidine-placebo [control', 'venetoclax-azacitidine', 'azacitidine plus either venetoclax or placebo']","['incidence of complete remission', 'febrile neutropenia', 'neutropenia', 'Infections of any grade', 'overall survival', 'incidence of febrile neutropenia', 'serious adverse events', 'median overall survival', 'nausea of any grade', 'grade 3 or higher thrombocytopenia', 'incidence of remission', 'composite complete remission (complete remission or complete remission with incomplete hematologic recovery']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C0004475', 'cui_str': 'Azacitidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}]",431.0,0.348327,The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.,"[{'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Jonas', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Pullarkat', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thirman', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Garcia', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Letai', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fenaux', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Havelange', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Esteve', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Vlatko', 'Initials': 'V', 'LastName': 'Pejsa', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Porkka', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lavie', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Roberto M', 'Initials': 'RM', 'LastName': 'Lemoli', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Turgut', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Wan-Jen', 'Initials': 'WJ', 'LastName': 'Hong', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Jalaja', 'Initials': 'J', 'LastName': 'Potluri', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Pratz', 'Affiliation': 'From the Department of Leukemia, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., M.K.); the Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis School of Medicine, Sacramento (B.A.J.), the Department of Hematology and Hematopoietic Cell Transplantation and Gehr Family Center for Leukemia Research, City of Hope Comprehensive Cancer Center, Duarte (V. Pullarkat), and Genentech, South San Francisco (W.-J.H.) - all in California; the Section of Hematology and Oncology, Department of Medicine, University of Chicago Medicine, Chicago (M.J.T.), and AbbVie, North Chicago (Y.Z., J.P.) - both in Illinois; the Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.S.G., A.L.); the Australian Centre for Blood Diseases, Alfred Hospital and Monash University, Melbourne, VIC (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H.D.); Hôpital St. Louis, Assistance Publique-Hôpitaux de Paris and Université de Paris, Paris (P.F.); the Third Medical Department for Hematology and Oncology, Hanusch Hospital, Vienna (E.K.); the Department of Hematology, Cliniques Universitaires Saint-Luc, Brussels (V.H.); the Department of Medicine, McMaster University, Hamilton, ON, Canada (B.L.); the Department of Hematology, Hospital Clinic, August Pi i Sunyer Biomedical Research Institute, Barcelona (J.E.); the Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences, Peking Union Medical College, Tianjin, China (J.W.); the Department of Hematology, University Hospital Dubrava, University of Zagreb School of Medicine, Zagreb, Croatia (V. Pejsa); the Department of Clinic Subjects, University Hospital Ostrava-Poruba, Ostrava, Czech Republic (R.H.); Helsinki University Hospital Comprehensive Cancer Center, University of Helsinki, Helsinki (K.P.); the Faculty of Medicine, Department of Hematology, University of Debrecen, Debrecen, Hungary (A.I.); Hadassah Medical Center, Jerusalem (D.L.); the Clinic of Hematology, Department of Internal Medicine, University of Genoa, and San Martino Hospital IRCCS - both in Genoa, Italy (R.M.L.); the Department of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan (K.Y.); the Department of Internal Medicine, Seoul National University College of Medicine (S.-S.Y.), and the Department of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-H.J.) - both in Seoul, South Korea; the Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan (S.-P.Y.); the Faculty of Medicine, Department of Internal Medicine, Division of Hematology, Ondokuz Mayıs University, Samsun, Turkey (M.T.); and Abramson Cancer Center, University of Pennsylvania, Philadelphia (K.W.P.).'}]",The New England journal of medicine,['10.1056/NEJMoa2012971']
3004,32812046,A qualitative account of young people's experiences of alcohol screening and brief interventions in schools: SIPS Jr-HIGH trial findings.,"BACKGROUND


The United Kingdom (UK) has seen a decrease in the number of young people drinking alcohol. However, the UK prevalence of underage drinking still ranks amongst the highest in Western Europe. Whilst there is a wealth of evidence reporting on the effectiveness of both primary, and secondary interventions, there are few reports of the experiences of young people who receive them.
METHODS


The present study reports findings from interviews with 33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England. All interviews were analysed using inductive applied thematic analysis.
RESULTS


Three major themes were identified following the analysis process: 1) drinking identities and awareness of risk; 2) access to support and advice in relation to alcohol use; and 3) appraisal of the intervention and potential impact on alcohol use.
CONCLUSIONS


There appeared to be a reluctance from participants to describe themselves as someone who drinks alcohol. Furthermore, those who did drink alcohol often did so with parental permission. There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff. Overall participants felt the intervention was useful, but would be better suited to 'heavier' drinkers.",2020,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"['33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England', ""young people's experiences of alcohol screening and brief interventions in schools""]",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],[],33.0,0.0264986,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Giles', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'McGeechan', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Scott', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boniface', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramsay', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hendrie', 'Affiliation': 'Centre for Health Services Research, University of Kent, Canterbury, Kent, CT2 7NF, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Faculty of Education, Health and Community, Liverpool John Moores University, Liverpool, L3 2 ET, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz074']
3005,32817311,Vitamin K Supplementation to Improve Vascular Stiffness in CKD: The K4Kidneys Randomized Controlled Trial.,"BACKGROUND


Vascular calcification, a risk factor for cardiovascular disease, is common among patients with CKD and is an independent contributor to increased vascular stiffness and vascular risk in this patient group. Vitamin K is a cofactor for proteins involved in prevention of vascular calcification. Whether or not vitamin K supplementation could improve arterial stiffness in patients with CKD is unknown.
METHODS


To determine if vitamin K supplementation might improve arterial stiffness in patients in CKD, we conducted a parallel-group, double-blind, randomized trial in participants aged 18 or older with CKD stage 3b or 4 (eGFR 15-45 ml/min per 1.73 m 2 ). We randomly assigned participants to receive 400  μ g oral vitamin K2 or matching placebo once daily for a year. The primary outcome was the adjusted between-group difference in carotid-femoral pulse wave velocity at 12 months. Secondary outcomes included augmentation index, abdominal aortic calcification, BP, physical function, and blood markers of mineral metabolism and vascular health. We also updated a recently published meta-analysis of trials to include the findings of this study.
RESULTS


We included 159 randomized participants in the modified intention-to-treat analysis, with 80 allocated to receive vitamin K and 79 to receive placebo. Mean age was 66 years, 62 (39%) were female, and 87 (55%) had CKD stage 4. We found no differences in pulse wave velocity at 12 months, augmentation index at 12 months, BP, B-type natriuretic peptide, or physical function. The updated meta-analysis showed no effect of vitamin K supplementation on vascular stiffness or vascular calcification measures.
CONCLUSIONS


Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Vitamin K therapy to improve vascular health in patients with chronic kidney disease, ISRCTN21444964 (www.isrctn.com).",2020,"CONCLUSIONS


Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
","['participants aged 18 or older with CKD stage 3b or 4 (eGFR 15-45 ml/min per 1.73 m 2 ', 'CKD', 'patients with chronic kidney disease, ISRCTN21444964 (www.isrctn.com', 'individuals with CKD', 'patients with CKD', '159 randomized participants in the modified intention-to-treat analysis, with 80 allocated to receive', 'Mean age was 66 years, 62 (39%) were female, and 87 (55%) had CKD stage 4', 'patients in CKD']","['Vitamin K', 'Vitamin K Supplementation', 'Vitamin K2 supplementation', 'vitamin K supplementation', 'vitamin K and 79 to receive placebo', '400  μ', 'g oral vitamin K2 or matching placebo']","['arterial stiffness', 'carotid-femoral pulse wave velocity', 'augmentation index, abdominal aortic calcification, BP, physical function, and blood markers of mineral metabolism and vascular health', 'pulse wave velocity at 12 months, augmentation index at 12 months, BP, B-type natriuretic peptide, or physical function', 'vascular stiffness', 'vascular health', 'vascular stiffness or vascular calcification measures']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",159.0,0.783004,"CONCLUSIONS


Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, National Institute for Health Research Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle-upon-Tyne National Health Service Trust, Tyne, United Kingdom Miles.Witham@newcastle.ac.uk.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Lees', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Band', 'Affiliation': 'Tayside Clinical Trials Unit, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Chantler', 'Affiliation': 'Department of Clinical Biochemistry, National Health Service Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Fulton', 'Affiliation': 'School of Nursing and Health Sciences, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Roberta C', 'Initials': 'RC', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ian V', 'Initials': 'IV', 'LastName': 'McCrea', 'Affiliation': 'Department of Radiology, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McGlynn', 'Affiliation': 'Clinical Research Facility, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Panarelli', 'Affiliation': 'Department of Clinical Biochemistry, National Health Service Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Maximilian R', 'Initials': 'MR', 'LastName': 'Ralston', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Rutherford', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Severn', 'Affiliation': 'Renal Unit, National Health Service Tayside, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Thomson', 'Affiliation': 'Clinical Research Facility, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Traynor', 'Affiliation': 'Clinical Research Facility, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Wetherall', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020020225']
3006,32828678,Features predicting treatment failure in pediatric acute otitis media.,"OBJECTIVES


To facilitate better antibiotic stewardship, we conducted this clinical trial to identify the prognostic features of treatment failure in pediatric acute otitis media (AOM).
STUDY


Design: This is a randomized, parallel-group, open-label, comparative clinical trial.
SUBJECTS AND METHODS


Children with AOM and aged between 1 month and 5 years were enrolled. Patients were randomly assigned to receive either amoxicillin alone (70 mg/kg) for five days, or the same with additional clarithromycin (15 mg/kg) for the initial three days. The clinical course of AOM was evaluated based on tympanic membrane scores. Failure of treatment for AOM was confirmed on day 14. Nasal conditions were also assessed by a clinical scoring system for acute rhinosinusitis.
RESULTS


Treatment failures occurred in 25 out of 129 (19.4%) children. The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years. The tympanic membrane scores on day 3 (P = 0.0334) and day 5 (P < 0.0001) and acute rhinosinusitis scores on day 5 (P = 0.0004) were higher in failure cases than in cured cases. Multivariate logistic regression analysis indicated significant associations between the treatment failure with tympanic membrane scores and acute rhinosinusitis scores on day 5, and the antimicrobial treatment regimen.
CONCLUSIONS


Improvement of acute rhinosinusitis and tympanic membrane scores on day five were important predictive features in failure of treatment for pediatric AOM. These results will be useful when discussing the treatment decisions with the patient's parents.",2021,The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years.,"['Children with AOM and aged between 1 month and 5 years were enrolled', 'pediatric acute otitis media', 'pediatric acute otitis media (AOM']","['clarithromycin', 'amoxicillin alone']","['tympanic membrane scores and acute rhinosinusitis scores', 'acute rhinosinusitis and tympanic membrane scores', 'tympanic membrane scores', 'acute rhinosinusitis scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2317131', 'cui_str': 'Acute rhinosinusitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",129.0,0.0719061,The ratio of treatment failures by age was significantly higher in children younger than 2 years than in children older than 2 years.,"[{'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Kono', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama-shi, Wakayama 641-8510, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Fukushima', 'Affiliation': 'Department of Dermatology & Otolaryngology, Hayashima Clinic, 1475-2 Hayashima, Hayashima-cho, Tokubo-gun, Okayama, 701-0304, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kamide', 'Affiliation': 'Kamide ENT Clinic, 2433-4 Denbou, Fuji-shi, Shizuoka 417-0061, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kunimoto', 'Affiliation': 'Kunimoto ENT Clinic, 5769-7 Tomo Aza Oohara, Numata-cho, Asa Minami-ku, Hiroshima -shi, Hiroshima 731-3161, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Matsubara', 'Affiliation': 'Matsubara ORL Clinic, 100 Ikeda-cho, Seki-shi, Gifu 501-3247, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Sawada', 'Affiliation': 'Sawada Eye and Ear Clinic, 1734-5 Fukui-cho, Kochi-shi, Kochi, 780-0965, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Shintani', 'Affiliation': 'Tomo ENT Clinic, 1-246 Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido 060-8611, Japan.'}, {'ForeName': 'Akihisa', 'Initials': 'A', 'LastName': 'Togawa', 'Affiliation': 'Sunsun Clinic, 569-1 Nogawa, Wakayama-shi, Wakayama 640-8481, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Uchizono', 'Affiliation': 'Sendai ENT Clinic, 1945-1 Taki-cho, Satsuma Sendai-shi, Kagoshima 895-0211, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Uno', 'Affiliation': 'Uno ENT Clinic, 3702-4 Kita Tomihara, Okayama-shi, Okayama, 701-1153, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Yamanaka', 'Affiliation': 'Moriya Keiyu Hospital, 980-1 Tachizawa, Moriya-shi, Ibaraki, 302-0118, Japan.'}, {'ForeName': 'Muneki', 'Initials': 'M', 'LastName': 'Hotomi', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Wakayama Medical University, 811-1 Kimiidera, Wakayama-shi, Wakayama 641-8510, Japan. Electronic address: mhotomi@wakayama-med.ac.jp.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.08.003']
3007,32839527,Minocycline differentially modulates human spatial memory systems.,"Microglia play a critical role in many processes fundamental to learning and memory in health and are implicated in Alzheimer's pathogenesis. Minocycline, a centrally-penetrant tetracycline antibiotic, inhibits microglial activation and enhances long-term potentiation, synaptic plasticity, neurogenesis and hippocampal-dependent spatial memory in rodents, leading to clinical trials in human neurodegenerative diseases. However, the effects of minocycline on human memory have not previously been investigated. Utilising a double-blind, randomised crossover study design, we recruited 20 healthy male participants (mean 24.6 ± 5.0 years) who were each tested in two experimental sessions: once after 3 days of Minocycline 150 mg (twice daily), and once 3 days of placebo (identical administration). During each session, all completed an fMRI task designed to tap boundary- and landmark-based navigation (thought to rely on hippocampal and striatal learning mechanisms respectively). Given the rodent literature, we hypothesised that minocycline would selectively modulate hippocampal learning. In line with this, minocycline biased use of boundary- compared to landmark-based information (t 980  = 3.140, p = 0.002). However, though this marginally improved performance for boundary-based objects (t 980  = 1.972, p = 0.049), it was outweighed by impaired landmark-based navigation (t 980  = 6.374, p < 0.001) resulting in an overall performance decrease (t 980  = 3.295, p = 0.001). Furthermore, against expectations, minocycline significantly reduced activity during memory encoding in the right caudate (t 977  = 2.992, p = 0.003) and five other cortical regions, with no significant effect in the hippocampus. In summary, minocycline impaired human spatial memory performance, likely through disruption of striatal processing resulting in greater biasing towards reliance on boundary-based navigation.",2020,"However, though this marginally improved performance for boundary-based objects (t 980  = 1.972, p = 0.049), it was outweighed by impaired landmark-based navigation (t 980  = 6.374, p < 0.001) resulting in an overall performance decrease (t 980  = 3.295, p = 0.001).",['20 healthy male participants (mean 24.6\u2009±\u20095.0 years'],"['placebo', 'minocycline', 'Minocycline', 'fMRI task designed to tap boundary- and landmark-based navigation']","['human spatial memory systems', 'overall performance decrease', 'human spatial memory performance', 'activity during memory encoding in the right caudate', 'hippocampal learning']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0814087', 'cui_str': 'Spatial Memory'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",20.0,0.177706,"However, though this marginally improved performance for boundary-based objects (t 980  = 1.972, p = 0.049), it was outweighed by impaired landmark-based navigation (t 980  = 6.374, p < 0.001) resulting in an overall performance decrease (t 980  = 3.295, p = 0.001).","[{'ForeName': 'Sam C', 'Initials': 'SC', 'LastName': 'Berens', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, BN1 9QH, UK.'}, {'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Bird', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, BN1 9QH, UK.'}, {'ForeName': 'Neil A', 'Initials': 'NA', 'LastName': 'Harrison', 'Affiliation': 'Cardiff University Brain Research Imaging Centre, Cardiff University, Cardiff, CF24 4HQ, UK. HarrisonN4@cardiff.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00811-8']
3008,32855201,Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial.,"OBJECTIVES


To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up.
DESIGN


Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial.
SETTING


Orthopaedic departments in five public hospitals in Finland.
PARTICIPANTS


146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised.
INTERVENTIONS


APM or placebo surgery (diagnostic knee arthroscopy).
MAIN OUTCOME MEASURES


We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ≥1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale).
RESULTS


There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ≥1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar.
CONCLUSIONS


APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01052233 and NCT00549172).",2020,"There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively.","['146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised', 'Orthopaedic departments in five public hospitals in Finland']","['Arthroscopic partial meniscectomy', 'APM or placebo surgery (diagnostic knee arthroscopy', 'placebo', 'arthroscopic partial meniscectomy (APM']","['progression of radiographic knee osteoarthritis', 'risk of developing radiographic knee osteoarthritis', 'Lysholm knee score', 'mechanical symptoms', 'Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score', 'radiographic knee osteoarthritis', 'knee pain', 'knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0348073', 'cui_str': 'Medial meniscus structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee joint'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2200320', 'cui_str': 'Lysholm Knee Scoring Scale'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",146.0,0.385234,"There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively.","[{'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Sihvonen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pihlajalinna Oyj, Tampere, Pirkanmaa, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Paavola', 'Affiliation': 'Department of Orthopedics and Traumatology, Töölö Hospital, Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Malmivaara', 'Affiliation': 'Centre for Health and Social Economics - CHESS, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Itälä', 'Affiliation': 'Pohjola Hospital, Turku, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Joukainen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kalske', 'Affiliation': 'Department of Orthopedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Nurmi', 'Affiliation': 'Department of Orthopedics and Traumatology, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Jaanika', 'Initials': 'J', 'LastName': 'Kumm', 'Affiliation': 'Department of Medicine, Tartu Ulikool, Tartu, Tartumaa, Estonia.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Sillanpää', 'Affiliation': 'Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Kiekara', 'Affiliation': 'Medical Imaging Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Department of Orthopedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Clinical Epidemiology Unit, Orthopaedics, Lund University, Lund, Sweden.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo L N', 'Initials': 'TLN', 'LastName': 'Järvinen', 'Affiliation': 'Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland teppo.jarvinen@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of sports medicine,['10.1136/bjsports-2020-102813']
3009,32858371,Effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.,"OBJECTIVE


Patients may be afraid when they receive knowledge that medications are injected into the middle ear through the tympanic membrane using a fine needle during intratympanic treatment. The aim of this study was to evaluate the effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.
STUDY DESIGN


Prospective, Non-randomized, controlled trial.
SETTING


Tertiary academic medical center.
METHODS


A total of 85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus were included in this prospective study. 40 cases received video-assisted information before intratympanic steroid injection in the study group, while 45 cases were verbally informed face-to-face in the control group. Then, patient anxiety was measured using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI).
RESULTS


The mean VAS score was 3.58 ± 3.37 (mean rank = 42.09) in the study group and 3.87 ± 3.56 (mean rank = 43.81) in the control group. The mean STAI-S score was 37.03 ± 10.637 in the study group and 39.11 ± 11.783 in the control group. The mean STAI-T score was 40.18 ± 9.151 in the study group and 38.73 ± 11.438 in the control group. It was found that there were no statistically significant differences in the mean VAS, STAI-S and STAI-T scores between the two groups (p > 0.05).
CONCLUSION


We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.",2020,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"['40 cases received', 'Tertiary academic medical center', '85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus', 'patient anxiety']","['video-assisted information prior to intratympanic steroid injection', 'video-assisted information before intratympanic steroid injection']","['mean VAS, STAI-S and STAI-T scores', 'mean STAI-T score', 'mean STAI-S score', 'mean VAS score', 'Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI', 'patient anxiety']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",85.0,0.0321367,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"[{'ForeName': 'Nurdoğan', 'Initials': 'N', 'LastName': 'Ata', 'Affiliation': 'Department of Otorhinolaryngology, KTO Karatay University Medical Faculty, Medicana Hospital, Konya, Turkey. Electronic address: op.dr.na@gmail.com.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alataş', 'Affiliation': 'Department of Otolaryngology, Uşak University Medical Faculty, Uşak, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Güllüev', 'Affiliation': 'Department of Otorhinolaryngology, Medical Sciences University Konya Training and Research Hospital, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ""Department of Otolaryngology, Dr. Ali Kemal Belviranlı Maternity and Children's Hospital, Konya, Turkey.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102689']
3010,32811625,Temporal dynamics of the relationship between change in depressive symptoms and cannabis use in adolescents receiving psychosocial treatment for cannabis use disorder.,"AIMS


Cannabis use disorder (CUD) and depression frequently co-occur in youth. How depressive symptoms change over the course of CUD treatment and how they impact substance use treatment outcomes is unknown. In the current study, we examine the temporal relationships between cannabis use and depression in adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial.
DESIGN


Six hundred adolescents (age 12-18) with a CUD were randomly assigned to substance use treatment from one of five evidence-based psychosocial interventions. We assessed self-reported cannabis use frequency and depressive symptoms at baseline (BL) and again at 3-, 6-, 9, and 12-months. A bivariate latent change model assessed bidirectional effects of baseline levels and time-lagged changes in depressive symptoms and cannabis use on depression and cannabis use outcomes.
FINDINGS


Depressive symptoms (72%) and major depressive disorder (MDD) (18%) were common at BL. Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003). Time-lag analyses showed that within-subject change in depression (from one time point to the next) was predicted by previous depression (b = -0.71, p < .001) but not cannabis use (p = .068), and change (decrease) in cannabis use was predicted by previous (greater) depressive symptoms (b = -1.47, p < .001) but not cannabis use (p = .158), respectively.
CONCLUSION


These findings indicate an enduring relationship between decreasing cannabis use and decreasing depression among adolescents lasting for 9-months after receiving psychosocial interventions for CUD. The presence of depressive symptoms did not appear to interfere with substance use treatment or attenuate improvements in cannabis use frequency. A decrease in cannabis use was not contingent upon a reduction in depressive symptoms. These findings are limited by the possibility of regression to the mean for both cannabis use and depressive symptoms, and the lack of a nonintervention control group.",2020,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","['adolescents receiving psychosocial treatment for cannabis use disorder', 'adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial', 'Six hundred adolescents (age 12-18) with a CUD']",[],"['major depressive disorder (MDD', 'depression', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",600.0,0.127233,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","[{'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Virginia Commonwealth University, United States of America. Electronic address: albert.arias@vcuhealth.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammond', 'Affiliation': 'Johns Hopkins University School of Medicine, United States of America. Electronic address: chammo20@jhmi.edu.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Burleson', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: burleson@uchc.edu.'}, {'ForeName': 'Yifrah', 'Initials': 'Y', 'LastName': 'Kaminer', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: kaminer@uchc.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feinn', 'Affiliation': 'Quinnipiac University School of Medicine, United States of America. Electronic address: richard.feinn@quinnipiac.edu.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Curry', 'Affiliation': 'Duke University School of Medicine, United States of America. Electronic address: john.curry@duke.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, United States of America. Electronic address: mdennis@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108087']
3011,32817078,Efficacy and Tolerability of High- versus Low-dose Lenalidomide Maintenance Therapy of Multiple Myeloma after Autologous Blood Stem Cell Transplantation.,"PURPOSE


For multiple myeloma, high-dose chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT) at 10-15 mg/day is considered standard of care. However, dose reductions due to side effects are common and median LenMT doses achieved over time may remain lower. Dose response during LenMT has never been investigated.
PATIENTS AND METHODS


In a multicenter, randomized, open-label trial, patients with multiple myeloma after ASCT and high-dose lenalidomide consolidation therapy (CT) at 25 mg/day were randomized to receive LenMT at either 25 or 5 mg/day. Primary endpoint was progression-free survival (PFS).
RESULTS


Ninety-four patients (median age, 58 years) were randomized to either arm, with 22% having International Staging System (ISS) stage 3 and 22% being in complete remission (CR). After median follow-up of 46.7 months, median doses of 14.5 and 5 mg/day were achieved in the two arms; 53% of dose reductions occurring during CT. In the high- and the low-dose arm, median PFS was 44.8 and 33.0 months (HR, 0.65; 95% CI, 0.44-0.97;  P  = 0.032), 36% and 23% of patients had stringent CR as best response ( P  = 0.08), and 4-year OS was 79% and 67% ( P  = 0.16), respectively. Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose adjustments. SPM incidence and quality-of-life (QoL) scores in both arms were similar.
CONCLUSIONS


LenMT dose correlated with efficacy and toxicity. High rates of dose reductions during CT argue against a high starting dose. However, continuous up- and down-titration for each patient to the current maximum tolerated dose is prudent.",2020,"Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments.","['Ninety-four patients (median age 58 years', 'multiple myeloma after autologous blood stem cell transplantation']","['lenalidomide maintenance therapy', 'ASCT and high-dose lenalidomide consolidation therapy (CT', 'chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT', 'LenMT']","['Hematologic toxicity, grade ≥3 neutropenia, and infections', '4-year OS', 'Efficacy and tolerability', 'SPM incidence and QoL scores', 'efficacy and toxicity', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",94.0,0.163084,"Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Fenk', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany. fenk@med.uni-duesseldorf.de.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Marienhospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heinsch', 'Affiliation': 'Helios St. Johannis Hospital Duisburg, Duisburg, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Rummel', 'Affiliation': 'Justus-Liebig University Giessen, Giessen, Germany.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kroger', 'Affiliation': 'University Cancer Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Boquoi', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Gerrlich', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Baier', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Liesenjohann', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Hauck', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ingrida', 'Initials': 'I', 'LastName': 'Savickaite', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'University Hospital Heidelberg and National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Aul', 'Affiliation': 'Helios St. Johannis Hospital Duisburg, Duisburg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Strapatsas', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dienst', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kondakci', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Haas', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Kobbe', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0841']
3012,32817266,Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.,"OBJECTIVES


To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.
METHODS


Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.
RESULTS


From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group;  P  =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group;  P  = .88). Infant growth in both groups was suboptimal (the mean weight-for-age  z  scores were -1.1 in the intervention group and -1.2 in the control group;  P  = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group;  P  < .001).
CONCLUSIONS


When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.",2020,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","['Congenital Heart Disease', 'parents of infants recovering from cardiac surgery and their infants', 'From 2012 to 2016', '219 parent-infant dyads were enrolled; 109', 'Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers', 'infants discharged from the hospital after cardiac surgery for congenital heart disease']","['telehealth home monitoring program (REACH), layered on usual care']","['readmitted to the hospital', 'Suboptimal infant growth and hospital readmissions', 'total Parenting Stress Index', 'posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores', 'Infant growth', 'parenting stress', 'mean Ulm Quality of Life Inventory']","[{'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0471754,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff Cooper', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania; medoff@upenn.edu.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Marino', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Desiree A', 'Initials': 'DA', 'LastName': 'Fleck', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amy Jo', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Golfenshtein', 'Affiliation': 'Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': 'Division of Cardiology, Department of Pediatrics and.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Costello', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Hanlon', 'Affiliation': 'Department of Statistics, College of Science, Virginia Polytechnic Institute and State University, Blacksburg, Virginia; and.'}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': 'Department of Anesthesia and Critical Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pediatrics,['10.1542/peds.2020-0531']
3013,32827835,Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.,"AIM


The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.
METHODS


This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.
RESULTS


Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.
CONCLUSIONS


Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.
TRIAL REGISTRATION


Clinicaltrials. gov: NCT00378560 and NCT00411749.",2020,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"['female Japanese 4vHPV clinical trial participants', 'Japanese female clinical trial participants', 'Japanese young women aged 18-26 years (N\u202f=\u202f1021; NCT00378560) and girls aged 9-17 years (N\u202f=\u202f107; NCT00411749']","['vaccination with quadrivalent human papillomavirus vaccine', 'injection-site reactions', '4vHPV vaccine', 'quadrivalent human papillomavirus (4vHPV) vaccine', 'placebo']","['severe injection-site AEs', 'erythema, pain, pruritus, and swelling ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.597729,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Shirakawa', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: masayoshi.shirakawa@merck.com.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshie.sugawara@merck.com.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Shuto', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: michiko.shutou@merck.com.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: miyuki.sawata@merck.com.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshiyuki.tanaka@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100205']
3014,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
3015,32851513,Desflurane and sevoflurane concentrations in blood passing through the oxygenator during cardiopulmonary bypass: a randomized prospective pilot study.,"PURPOSE


Volatile anesthetics (VAs) protect myocardial cells in cardiovascular surgery. A recent clinical trial of cardiopulmonary bypass (CPB) surgery reported no significant difference in mortality rates between the use of VAs and total intravenous anesthetics at 1 year postoperatively. However, oxygenator function may affect the VA pharmacokinetics. Thus, we measured the VA blood concentrations during CPB in patients managed with four different microporous polypropylene hollow fiber membrane oxygenators.
METHODS


Twenty-four patients scheduled for elective CPB were randomly allocated to one of the two VA groups (desflurane and sevoflurane groups) and, then, randomly divided into one of four oxygenator groups: Terumo, LivaNova, Medtronic, and Senko (n = 3). Additionally, in each VA group, three patients were randomly selected and redundantly allocated to the human lung group (for control blood VA concentration without oxygenator). Blood samples collected 20 min after starting 6.0 vol% desflurane or 1.7 vol% sevoflurane were analyzed using gas chromatography. Oxygenator-related complications and structural changes in the membrane surface of each oxygenator after surgery were evaluated.
RESULTS


The mean (standard deviation) concentrations of desflurane and sevoflurane in the human lung were 182.4 (23.2) and 54.0 (9.6) μg/ml, respectively; not significantly different from those in the four oxygenator groups. No oxygenator-related complications occurred. Structural changes in membrane fibers did not occur after clinical use, except for difficulty in image acquisition with Senko products.
CONCLUSION


Our results demonstrated that the blood concentrations of desflurane and sevoflurane passing through oxygenators used during CPB were similar to those in the human lung control.",2020,No oxygenator-related complications occurred.,"['patients managed with four different microporous polypropylene hollow fiber membrane oxygenators', 'Twenty-four patients scheduled for elective CPB', 'blood passing through the oxygenator during cardiopulmonary bypass']","['VA groups (desflurane and sevoflurane', 'LivaNova, Medtronic, and Senko', 'desflurane or 1.7 vol% sevoflurane', 'human lung group (for control blood VA concentration without oxygenator', 'Desflurane', 'Volatile anesthetics (VAs', 'cardiopulmonary bypass (CPB) surgery']","['VA blood concentrations', 'blood concentrations', 'mortality rates', 'mean (standard deviation) concentrations of desflurane and sevoflurane']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0032582', 'cui_str': 'Polypropylene'}, {'cui': 'C0475405', 'cui_str': 'Hollow fiber membrane'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]",24.0,0.0610064,No oxygenator-related complications occurred.,"[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan. takahiro@med.nagoya-u.ac.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Department of Perioperative Management System, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ishii', 'Affiliation': 'Department of Legal Medicine and Bioethics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kubo', 'Affiliation': 'Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02844-1']
3016,32852600,Does patient-specific instrumentation increase the risk of notching in the anterior femoral cortex in total knee arthroplasty? A comparative prospective trial.,"PURPOSE


Patient-specific instrumentation (PSI) was usually applied in total knee arthroplasty (TKA) to acquire a favourable alignment. We hypothesized that using PSI had a potential risk of notching in the anterior femoral cortex, because the femoral component may be placed in an overextension position due to the distal femoral sagittal anteversion. The aim of this study was to figure out the relationship between the notch and the distal femoral sagittal anteversion in PSI-assisted TKA.
METHODS


One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA) were randomly divided into conventional instrumentation (CI) group and PSI group. The computed tomography (CT) data of lower extremities was collected and imported to the Mimics software to reconstruct the three-dimensional (3D) bone image of the femur. The angle between distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA) on sagittal plane was defined as distal femoral sagittal anteverted angle (DFSAA) and measured. The number of notch intra-operative and post-operative was recorded. Then, we calculated the incidence of the notch and analyzed its relationship with DFSAA.
RESULTS


The average DFSAA of 262 femurs is 2.5° ± 1.5° (range, 0.0°-5.7°). When DFSAA ≥ 3°, the incidence of notch was 7.10% in CI group and 33.30% in PSI group, respectively, which shows significant statistical difference in the two groups (P = 0.016 < 0.05). When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05).
CONCLUSION


DFSAA could be taken as an indicator to predict the notch when performing TKA assisted with PSI. Especially when the DFSAA ≥ 3°, the risk of notch could be markedly increased.",2020,"When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05).
",['One hundred thirty-one patients who were to undergo total knee arthroplasty (TKA'],['conventional instrumentation (CI) group and PSI group'],"['incidence of notch', 'number of notch intra-operative and post-operative', 'distal femoral anatomic axis (DFAA) and femoral mechanical axis (FMA']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]",131.0,0.0329578,"When DFSAA < 3°, the incidence of notch was 6.50% in CI group and 5.30% in PSI group, respectively, which shows no significant statistical difference in the two groups (P = 0.667 > 0.05).
","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ke', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Tianfei', 'Initials': 'T', 'LastName': 'Ran', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yongqin', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Mingrui', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Xinqiao Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China. 52solar@sina.cn.'}]",International orthopaedics,['10.1007/s00264-020-04779-4']
3017,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
3018,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
3019,32857254,"Effectiveness of Cessation Messages Targeting Pregnant and Nonpregnant Female Smokers in the United States: A Cross-Sectional Analysis into the Impact of Pregnancy, Self-Efficacy, and Risk Perception.","OBJECTIVES


Roughly 10% of pregnant women are current smokers. Improving smoking cessation in this population before and during pregnancy is essential to prevent adverse fetal outcomes. This study aimed to examine cessation messages targeting American women.
METHODS


An obstetrics-gynecological clinic-based sample of female, current smokers of reproductive age (18-44 years old) was recruited (n = 135) from January to May 2019; half (51.2%) were currently pregnant. Participants completed a within-subjects study with a randomized set of gain- and loss-framed text-only pregnancy-related cessation messages (5 each). Each individual message was rated on a validated, 10-point scale for perceived effectiveness; responses to the seven items were averaged. Regression analyses examined differences in effectiveness ratings by message framing.
RESULTS


Study participants (female smokers) rated the gain-framed messages as slightly more effective than loss-framed messages (7.9 versus 7.7, p < 0.01). After adjusting for quit intention and pregnancy, the relationship between gain- and loss-framing and effectiveness ratings was modified by both self-efficacy and risk perceptions. Women who perceived high risks of smoking during pregnancy had higher effectiveness ratings of both gain- and loss-framed cessation messages, compared to women who perceived low risks. Lower cessation self-efficacy was significantly associated with lower effectiveness ratings for gain- and loss-framed messages (1.53 and 1.92, respectively; p < 0.05).
CONCLUSIONS FOR PRACTICE


Women with lower self-efficacy and low risk perception of smoking risks had the lowered effectiveness ratings for both frames of cessation messages. Enhancing self-efficacy and risk perceptions through clinical interventions may improve the effectiveness of targeted messages to promote quitting smoking before or during pregnancy.",2020,"Women who perceived high risks of smoking during pregnancy had higher effectiveness ratings of both gain- and loss-framed cessation messages, compared to women who perceived low risks.","['An obstetrics-gynecological clinic-based sample of female, current smokers of reproductive age (18-44\xa0years old) was recruited (n\u2009=\u2009135) from January to May 2019; half (51.2%) were currently pregnant', 'pregnant women are current smokers', 'Pregnant and Nonpregnant Female Smokers in the United States', 'American women']",['gain- and loss-framed text-only pregnancy-related cessation messages'],"['effectiveness ratings', 'Pregnancy, Self-Efficacy, and Risk Perception', 'Lower cessation self-efficacy', 'effectiveness ratings for gain- and loss-framed messages']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]",,0.0616887,"Women who perceived high risks of smoking during pregnancy had higher effectiveness ratings of both gain- and loss-framed cessation messages, compared to women who perceived low risks.","[{'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Busho', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Macisco', 'Affiliation': 'The Ohio State University College of Public Health, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Austin G', 'Initials': 'AG', 'LastName': 'Oslock', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Worly', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Klein', 'Affiliation': 'The Ohio State University College of Public Health, The Ohio State University, Columbus, OH, USA. Klein.232@osu.edu.'}]",Maternal and child health journal,['10.1007/s10995-020-03001-6']
3020,32860399,"No independent or combined effects of vitamin D and conjugated linoleic acids on muscle protein synthesis in older adults: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Aging is associated with skeletal muscle anabolic resistance (i.e., reduced muscle protein synthesis during anabolic conditions such as hyperaminoacidemia). The results from studies conducted in cell culture systems and animals suggest that both vitamin D and conjugated linoleic acids (CLAs) stimulate muscle protein synthesis.
OBJECTIVES


To conduct a randomized, double-blind, placebo-controlled clinical trial to determine the independent and combined effects of dietary vitamin D and CLA supplementation on myofibrillar protein synthesis rates in sedentary older adults.
METHODS


Thirty-two sedentary, older adults were randomized to receive either: 1) 2000 IU vitamin D-3 (Vit D) per day; 2) 4000 mg CLA per day; 3) both Vit D (2000 IU/d) and CLA (4000 mg/d); or 4) placebo for 8 wk. Myofibrillar protein synthesis rates were evaluated by using intravenous [ring-2H5]phenylalanine infusion in conjunction with muscle biopsies during basal, postabsorptive conditions and during combined amino acid and insulin infusion before and after the supplementation period.
RESULTS


Before the intervention, basal myofibrillar protein synthesis rates were not different among groups (Placebo: 0.033 ± 0.003; Vit D: 0.034 ± 0.002; CLA: 0.029 ± 0.005; Vit D + CLA: 0.038 ± 0.005 %·h-1), and hyperinsulinemia-hyperaminoacidemia increased myofibrillar protein synthesis rates by ∼35%. Compared with placebo, neither Vit D nor CLA nor combined Vit D + CLA supplementation affected the basal myofibrillar protein synthesis rates (placebo: 0.040 ± 0.004%/h; Vit D: 0.044 ± 0.006%/h; CLA: 0.039 ± 0.006%/h; Vit D + CLA: 0.040 ± 0.007%/h) or the hyperinsulinemia-hyperaminoacidemia-induced increase in myofibrillar protein synthesis (percentage increase from basal before and after the interventions: placebo, 30 ± 11 and 36 ± 11; Vit D, 38 ± 8 and 34 ± 10; CLA, 50 ± 14 and 51 ± 16; Vit D + CLA, 29 ± 15 and 35 ± 8).
CONCLUSIONS


Vitamin D and/or CLA supplementation, at the doses provided in our study, does not have muscle anabolic effects in sedentary older adults.The study was registered at clinicaltrials.gov (NCT03115775).",2020,"Compared with placebo, neither Vit D nor CLA nor combined Vit D + CLA supplementation affected the basal myofibrillar protein synthesis rates (placebo: 0.040 ± 0.004%/h; Vit D: 0.044 ± 0.006%/h; CLA: 0.039 ± 0.006%/h; Vit D + CLA: 0.040 ± 0.007%/h) or the hyperinsulinemia-hyperaminoacidemia-induced increase in myofibrillar protein synthesis (percentage increase from basal before and after the interventions: placebo, 30 ± 11 and 36 ± 11; Vit D, 38 ± 8 and 34 ± 10; CLA, 50 ± 14 and 51 ± 16; Vit D + CLA, 29 ± 15 and 35 ± 8).
","['older adults', 'sedentary older adults', 'Thirty-two sedentary, older adults']","['vitamin D and conjugated linoleic acids (CLAs', 'vitamin D-3 (Vit D) per day', 'dietary vitamin D and CLA supplementation', 'CLA', 'intravenous [ring-2H5]phenylalanine infusion', 'placebo', 'vitamin D and conjugated linoleic acids', 'placebo, neither Vit D nor CLA nor combined Vit D\xa0+\xa0CLA supplementation', 'Vitamin D and/or CLA supplementation', 'Vit D']","['Myofibrillar protein synthesis rates', 'myofibrillar protein synthesis', 'hyperinsulinemia-hyperaminoacidemia increased myofibrillar protein synthesis rates', 'muscle anabolic effects', 'myofibrillar protein synthesis rates', 'basal myofibrillar protein synthesis rates', 'muscle protein synthesis']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0050156', 'cui_str': '9,11-linoleic acid'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0597295', 'cui_str': 'Genetic translation'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C3179309', 'cui_str': 'Anabolic Effects'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",32.0,0.40154,"Compared with placebo, neither Vit D nor CLA nor combined Vit D + CLA supplementation affected the basal myofibrillar protein synthesis rates (placebo: 0.040 ± 0.004%/h; Vit D: 0.044 ± 0.006%/h; CLA: 0.039 ± 0.006%/h; Vit D + CLA: 0.040 ± 0.007%/h) or the hyperinsulinemia-hyperaminoacidemia-induced increase in myofibrillar protein synthesis (percentage increase from basal before and after the interventions: placebo, 30 ± 11 and 36 ± 11; Vit D, 38 ± 8 and 34 ± 10; CLA, 50 ± 14 and 51 ± 16; Vit D + CLA, 29 ± 15 and 35 ± 8).
","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'van Vliet', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fappi', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Dominic N', 'Initials': 'DN', 'LastName': 'Reeds', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Mittendorfer', 'Affiliation': 'Center for Human Nutrition, Washington University School of Medicine, St Louis, MO, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa240']
3021,32860406,The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial.,"AIMS 


Bone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent.
METHODS AND RESULTS 


Originally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group.
CONCLUSIONS 


Although BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.",2020,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"['acute myocardial infarction', 'patients following acute myocardial infarction (AMI', '375 patients were recruited: 185 patients', 'patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI']","['Bone marrow-derived mononuclear cell', 'treatment arm (intracoronary infusion of BM-MNCs 2-8\u2009days after PPCI', 'intracoronary infusion of bone marrow-derived mononuclear cells', 'BM-MNC) therapy']","['adverse events nor serious adverse events', 'hospitalized for stroke', 'myocardial recovery', 'heart failure']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",375.0,0.0908235,All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernández-Avilés', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital Aalst, Aalst, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Belmans', 'Affiliation': 'KU, Leuven, Leuven, Belgium.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Crea', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Sheik', 'Initials': 'S', 'LastName': 'Dowlut', 'Affiliation': 'Centre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Galiñanes', 'Affiliation': ""Department of Cardiac Surgery, Reparative Therapy of the Heart, Vall d'Hebron Research Institute, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Marie-Claire', 'Initials': 'MC', 'LastName': 'Good', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hauskeller', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'University Hospitals (UZ) Leuven, Belgium.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshospitalet and University of Copenhagen, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Menasché', 'Affiliation': 'Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris, Paris, France.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Sanz-Ruiz', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Ylä-Herttuala', 'Affiliation': 'University of Eastern Finland, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa651']
3022,32865822,Transoral Robotic Surgical Proficiency Via Real-Time Tactile Collision Awareness System.,"OBJECTIVES


In 2009, the Food and Drug Administration approved the use of the surgical robotic system for removal of benign and malignant conditions of the upper aerodigestive tract. This novel application of robotic-assisted surgery, termed transoral robotic surgery (TORS), places robotic instruments and camera system through the mouth to reach recessed areas of the pharynx and larynx. Over the successive decade, there was a rapid adoption of TORS with a surgical growth rate that continues to increase. Despite the rapid clinical acceptance, the field of TORS has not yet seen substantive changes or advances in the technical shortcomings, the lack of which has restricted objective TORS-specific surgical skills assessment as well as subsequent skills improvement efforts. One of the primary technical challenges of TORS is operating in a confined space, where the robotic system is maneuvered within the restrictive boundaries of the mouth and throat. Due to these confined boundaries of the pharynx, instruments can frequently collide with anatomic structures such as teeth and bone, producing anatomic collisions. Therefore, we hypothesized that anatomic collisions negatively impact TORS surgical performance. Secondarily, we hypothesized that avoidance of unwanted anatomic collisions could improve TORS surgical proficiency.
METHODS


Design and fidelity testing for a custom TORS training platform with an integrated anatomic collision-sensing system providing real-time tactile feedback is described. Following successful platform assembly and testing, validation study using the platform was carried through prospective surgical training with trial randomization. Twenty otolaryngology-head and neck surgery residents, each trainee performing three discrete mock surgical trials (n = 60), performed the initial system validation. Ten of the 20 residents were randomized to perform the surgical trials utilizing the real-time feedback system. The remaining 10 residents were randomized to perform the surgical trials without the feedback system, although the system still could record collision data. Surgical proficiency was measured by Global Evaluative Assessment of Robotic Skills (GEARS) score, time to completion, and tumor resection scores (categorical scale ranging 0-3, describing the adequacy of resection).
RESULTS


Major anatomic collisions (greater than 5N of force) negatively affected GEARS robotic skills. A mixed model analysis demonstrated that for every additional occurrence of a major collision, GEARS robotic skills assessment score would decrease by 0.29 points (P = .04). Real-time collision awareness created significantly fewer major (> 5 N) anatomic collisions with the tactile feedback system active (n = 30, mean collisions = 2.9 ± 4.2) as compared with trials without tactile feedback (n = 30, mean collisions = 12.53 ± 23.23) (P < .001). The second assessment measure of time to completion was unaffected by the presence of collisions or by the use of tactile feedback system. The third proficiency assessment was measured with tumor resection grading. Tumor resection scores was significantly (P = .02) improved with collision awareness system activated than trials without collision awareness.
CONCLUSION


In order to test our primary hypothesis, a novel TORS training platform was successfully developed that provides collision force measurements including frequency, severity, and duration of anatomic collisions. Additionally, the platform was modulated to provide real-time tactile feedback of the occurrence of out-of-field collisions. Utilizing this custom platform, our hypothesis that anatomic collisions during TORS diminishes surgical performance was supported. Additionally, our secondary hypothesis that subsequent reduction of anatomic collisions improves TORS proficiency was supported by the surgical trial. Dedicated investigation to characterize the effect size and clinical impact is required in order to translate this finding into training curriculums and into clinical utilization.
LEVEL OF EVIDENCE


II (Randomized trial) Laryngoscope, 130:S1-S17, 2020.",2020,The second assessment measure of time to completion was unaffected by the presence of collisions or by the use of tactile feedback system.,"['Twenty otolaryngology-head and neck surgery residents, each trainee performing three discrete mock surgical trials (n = 60', 'Ten of the 20 residents']","['robotic-assisted surgery, termed transoral robotic surgery (TORS', 'Transoral Robotic Surgical Proficiency']","['GEARS robotic skills', 'Global Evaluative Assessment of Robotic Skills (GEARS) score, time to completion, and tumor resection scores (categorical scale ranging 0-3, describing the adequacy of resection', 'Tumor resection scores']","[{'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",20.0,0.0408107,The second assessment measure of time to completion was unaffected by the presence of collisions or by the use of tactile feedback system.,"[{'ForeName': 'Abie H', 'Initials': 'AH', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Head and Neck Surgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, U.S.A.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Head and Neck Surgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, U.S.A.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Surgery, Center for Advanced Surgical and Interventional Technology, David Geffen School of Medicine, Los Angeles, California, U.S.A.'}, {'ForeName': 'Aadesh', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Center for Advanced Surgical and Interventional Technology, David Geffen School of Medicine, Los Angeles, California, U.S.A.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Le', 'Affiliation': 'Department of Surgery, Center for Advanced Surgical and Interventional Technology, David Geffen School of Medicine, Los Angeles, California, U.S.A.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abiri', 'Affiliation': 'Department of Surgery, Center for Advanced Surgical and Interventional Technology, David Geffen School of Medicine, Los Angeles, California, U.S.A.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Berke', 'Affiliation': 'Department of Head and Neck Surgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, U.S.A.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Geoghegan', 'Affiliation': 'Department of Surgery, Center for Advanced Surgical and Interventional Technology, David Geffen School of Medicine, Los Angeles, California, U.S.A.'}]",The Laryngoscope,['10.1002/lary.29034']
3023,32822656,Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial.,"BACKGROUND


Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap.
METHODS AND DESIGN


The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75 years and older, with MI (either STE or NSTE), MVD at coronary artery angiography, and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary end point will be the patient-oriented composite end point of all-cause death, any MI, any stroke, and any revascularization at 1 year. The key secondary end point will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5 years. The sample size for the study is 1,400 patients.
IMPLICATIONS


The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD to improve their clinical outcomes.",2020,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","['1400 patients', 'elderly patients with myocardial infarction', 'Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion', 'elderly patients']",['Physiology-guided revascularization versus optimal medical therapy'],"['patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year', 'composite of cardiovascular death and MI', 'Quality of life and physical performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0629355,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Biscaglia', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy. Electronic address: bscsmn@unife.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amat Santos', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernandez-Aviles', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Lanzilotti', 'Affiliation': 'U.O.C. Cardiologia, Ospedale Maggiore, Largo Nigrisoli 2, Bologna, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Department of Cardiology, Infermi Hospital, Rivoli, Italy; Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Fileti', 'Affiliation': 'Cardiology Department, S. Maria delle Croci Hospital, Viale Randi 5, Ravenna, Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Instituto de Investigación Hospital La Paz (IDIPAZ), University Hospital La Paz, Madrid, Spain, Madrid; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giannini', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Iginio', 'Initials': 'I', 'LastName': 'Colaiori', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Menozzi', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ruozzi', 'Affiliation': 'Cardiology Unit, Ospedale Civile di Baggiovara, Modena, Italy.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez Ibañes', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Díez Gil', 'Affiliation': 'Servicio de Cardiología, H. Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Calle del Prof Martin Lagos s/n, Madrid, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Via Pansini, Naples, Italy.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy; Institute of Cardiology, Jagiellonian University Medical College, ul. Sw Anny 12, Krakow, Poland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy; Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}]",American heart journal,['10.1016/j.ahj.2020.08.007']
3024,32828873,Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding.,"BACKGROUND AND AIMS


No prior randomized controlled trial (RCT) has reported patient outcomes of large over-the-scope clip (OTSC) compared to standard hemostasis as initial endoscopic treatment of severe NVUGIB. This was our study aim.
METHODS


Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe) were randomized to OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC). Patients and their healthcare providers were blinded to treatments and made all post-randomization management decisions. Ulcer patients received high dose intravenous infusions of proton pump inhibitors (PPI) for 3 days, then 27 days of oral PPI. 30 day outcomes were prospectively recorded; data management was with SAS; and data analysis was by a statistician.
RESULTS


53 patients (25 OTSC, 28 Standard) were randomized, with similar baseline risk factors. However, there were significant differences in OTSC vs. Standard groups in rates of rebleeding (4% vs. 28.6%; p = .017; relative risk 0.10, 95% confidence intervals 0.01, 0.91; number needed to treat 4); severe complications (0 % vs. 14.3%); and post-randomization units of red cell transfusions (0.04 vs. 0.68). All rebleeds occurred in patients with major SRH and none with lesser SRH.
CONCLUSION


1. OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions. 2. Patients with major stigmata benefited significantly from hemostasis with OTSC, but those with lesser stigmata did not. (ClinicalTrials.gov, Number: NCT03065465).",2020,"OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions.","['53 patients (25 OTSC, 28 Standard', ""Patients with bleeding ulcers or Dieulafoy's lesions and major stigmata of hemorrhage - SRH (active spurting bleeding, visible vessel, or clot) - or lesser SRH (oozing bleeding or flat spots - with arterial blood flow by Doppler probe"", 'Severe Non-Variceal Upper Gastrointestinal Bleeding', 'Ulcer patients']","['OTSC or standard endoscopic hemostasis (with hemoclips or multipolar electrocoagulation - MPEC', 'Scope Clip', 'OTSC', 'proton pump inhibitors (PPI']","['number needed to treat 4); severe complications', 'rates of rebleeding', 'rates of rebleeding, severe complications, and post-randomization red cell transfusions', 'hemostasis with OTSC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0333291', 'cui_str': 'Bleeding ulcer'}, {'cui': 'C0341217', 'cui_str': ""Dieulafoy's vascular malformation""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0441086', 'cui_str': 'Doppler probe'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085148', 'cui_str': 'Endoscopic Hemostasis'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]",2.0,0.223487,"OTSC significantly reduced rates of rebleeding, severe complications, and post-randomization red cell transfusions.","[{'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Jensen', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California; West Los Angeles Veterans Administration Medical Center, Los Angeles, California. Electronic address: djensen@mednet.ucla.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kovacs', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Ghassemi', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kaneshiro', 'Affiliation': 'CURE Digestive Diseases Research Core Center, Los Angeles, California; Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gornbein', 'Affiliation': 'Ronald Reagan UCLA Medical Center, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California; Department of Medical Statistics Core, Division of General Internal Medicine, Department of Medicine, David Geffen School of Medicine at UCLA, University of California, Los Angeles, Los Angeles, California.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.046']
3025,32829925,[Effects of music therapy on pain and oxidative stress in oocyte pick-up: a randomized clinical trial].,"BACKGROUND AND OBJECTIVE


The aim was to investigate the effects of Turkish classical music on pain and oxidative stress in patients undergoing oocyte pick-up.
METHODS


The study was a randomized, controlled trial. The groups included were Group NM (Non-Music), control group; Group PM, which comprised patients who listened to music before the operation; and Group CM, which comprised patients who listened to music both before and during the operation. Blood was drawn prior to the operation to measure the oxidative stress values. Pain, hemodynamic parameters, oxidative stress values were assessed postoperatively.
RESULTS


The number of patients requiring additional propofol was higher in Group PM than in Groups NM and CM (p=0.003). The postoperative Visual Analog Scale (VAS) score were lower in Groups PM and CM than in Group NM (p=0.001, p=0.007) in the 1 st  and 60 th  minutes. The postoperative VAS score was lower in Group CM than in Group NM (p=0.045) in the 5 th  minute. The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045). The postoperative blood glutathione peroxidase values were significantly higher in Groups PM and CM than in Group NM (p=0.001). The postoperative catalase values were significantly higher in Groups PM and CM than in Group NM (p=0.008 and p ≤0.001). The preoperative malondialdehyde values were significantly lower in Groups PM and CM than in Group NM. The preoperative nitric oxide values were higher in Groups PM and CM than in Group NM (p ≤0.001), whereas the postoperative nitric oxide values were lower in Groups PM and CM than in Group NM (p ≤0.001).
CONCLUSION


Turkish classical music has beneficial effects on pain and oxidative stress in oocyte pick-up patients.",2020,The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045).,"['patients undergoing oocyte pick-up', 'oocyte pick-up']","['control group; Group PM, which comprised patients who listened to music before the operation; and Group CM', 'music therapy', 'Turkish classical music']","['postoperative VAS score', 'postoperative blood glutathione peroxidase values', 'oxidative stress values', 'postoperative catalase values', 'preoperative malondialdehyde values', 'Pain, hemodynamic parameters, oxidative stress values', 'number of patients requiring additional propofol', 'postoperative additional analgesic requirements', 'postoperative nitric oxide values', 'preoperative nitric oxide values', 'postoperative Visual Analog Scale (VAS) score', 'pain and oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0356329,The postoperative additional analgesic requirements were lower in Groups PM and CM than in Group NM (p=0.045).,"[{'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Orak', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Onikişubat, Turquia. Electronic address: dryavuzorak@hotmail.com.'}, {'ForeName': 'Suleyman Murat', 'Initials': 'SM', 'LastName': 'Bakacak', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Obstetrics and Gynecology, Onikişubat, Turquia.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Yaylali', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Histology Department, Onikişubat, Turquia.'}, {'ForeName': 'Fatma Inanc', 'Initials': 'FI', 'LastName': 'Tolun', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Biochemistry, Onikişubat, Turquia.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kiran', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Obstetrics and Gynecology, Onikişubat, Turquia.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Boran', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Onikişubat, Turquia.'}, {'ForeName': 'Akif Hakan', 'Initials': 'AH', 'LastName': 'Kurt', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Medicine, Medical Pharmacology, Bolu, Turquia.'}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Doganer', 'Affiliation': 'Kahramanmaras Sutcu Imam University, Faculty of Medicine, Biostatistics and Medical Informatics, Onikişubat, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.015']
3026,32829945,Chronic Resistance Exercise Improves Functioning and Reduces Toll-Like Receptor Signaling in Elderly Patients With Postoperative Deconditioning.,"OBJECTIVE


Elderly patients continue to experience low levels of mobility during and following postoperative hospitalization that lead to persistent physical decline. Therefore, here we compared chronic resistance (CR) exercise against chronic aerobic (CA) exercise in ameliorating postoperative functioning and reducing proinflammatory muscular Toll-like receptor (TLR)-associated signaling in elderly postoperative patients.
METHODS


We conducted a prospective, randomized trial comparing the effects of 3 exercise programs (CR, CA, and CR + CA) in 66 elderly patients recovering from recent hip, femur, or pelvic fracture repair surgery. The primary outcomes were changes in anatomic/physical performance parameters (ie, maximal oxygen intake, endurance, quadriceps cross-sectional area, and maximum knee-extensor force). The secondary outcomes were changes in TLR/nuclear factor kappa beta signaling pathway marker expression.
RESULTS


Three of the 4 anatomic/physical performance parameters significantly improved for the CR and CR + CA cohorts. Muscular expression of myeloid differentiation primary response gene 88, transforming growth factor beta-activated kinase 1 (TLR signaling pathway markers), p50, p65, tumor necrosis factor α, and interleukin 6 (nuclear factor kappa beta signaling pathway markers) all showed significant reductions after CR and CR + CA. Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
CONCLUSIONS


Three months of CR or CR + CA improves maximal oxygen consumption, quadriceps cross-sectional area, and maximum knee-extensor force while lowering muscular proinflammatory signaling markers in elderly adults with postoperative deconditioning.",2020,"Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
","['elderly postoperative patients', 'Elderly Patients With Postoperative Deconditioning', 'elderly adults with postoperative deconditioning', 'Elderly patients', '66 elderly patients recovering from recent hip, femur, or pelvic fracture repair surgery']","['\u202fCA', 'Chronic Resistance Exercise', 'chronic resistance (CR) exercise against chronic aerobic (CA) exercise', '3 exercise programs (CR, CA, and CR\u202f+\u202fCA']","['changes in TLR/nuclear factor kappa beta signaling pathway marker expression', 'changes in anatomic/physical performance parameters (ie, maximal oxygen intake, endurance, quadriceps cross-sectional area, and maximum knee-extensor force', 'maximal oxygen consumption, quadriceps cross-sectional area, and maximum knee-extensor force', 'Muscular expression of myeloid differentiation primary response gene 88, transforming growth factor beta-activated kinase 1 (TLR signaling pathway markers), p50, p65, tumor necrosis factor α, and interleukin 6 (nuclear factor kappa beta signaling pathway markers', 'physical performance parameters', 'Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0379816', 'cui_str': 'MAP kinase kinase kinase 7'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}]",66.0,0.0703044,"Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
","[{'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Training, Sports Institute, Zhengzhou University, Zhengzhou, Henan, China. Electronic address: m18530021718@163.com.'}, {'ForeName': 'Xiaohai', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Rehabilitation Medicine, Hainan Provincial People's Hospital, Haikou, Hainan, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Rehabilitation, Sports Institute, Zhengzhou University, Zhengzhou, Henan, China.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.01.001']
3027,32838052,Application of randomization techniques for balancing site covariates in the adult day service plus pragmatic cluster-randomized trial.,"Cluster-randomized trials (CRTs) are increasingly common in pragmatic trials of interventions for older adults, where staff of existing clinics or service agencies deliver interventions. The Adult Day Service (ADS) Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers. Because sizable imbalances on important site characteristics might emerge from a simple randomization, we implemented a 3-stage constrained randomization approach to limit imbalance between intervention and usual care control conditions on 5 site characteristics: capacity; % of minority clients; % of clients with dementia; urban, rural or suburban location; and private or public ownership. In stage 1, the Balance Match Weighted (BMW) re-randomization procedure was used to assign 30 sites to ADS Plus or control arms based on the best randomization out of 20 total randomizations for minimizing site imbalance. In stage 2, propensity scores from the BMW logistic regression analysis for reserve sites were used to determine substitutions for randomized sites that opted out of the CRT prior to implementation. In stage 3, a minimization approach was used to add 20 more sites to the trial. A standardized metric based on the half-normal distribution of the absolute value of mean differences was used to assess site imbalance. After stage 3, the remaining imbalance for the 49 enrolled sites was reduced by 75% from what would have been expected from a simple randomization. Optimized randomization procedures with similar imbalance metrics should be used more routinely in pragmatic CRTs.",2020,Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers.,"['older adults', 'minority clients; % of clients with dementia; urban, rural or suburban location; and private or public ownership', 'older adults with cognitive impairments and their family caregivers']",[],['Adult Day Service (ADS'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0029981', 'cui_str': 'Ownership'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0833573,Plus intervention is delivered by trained staff at adult day service facilities to assist older adults with cognitive impairments and their family caregivers.,"[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Center on Aging and Health, Division of Geriatric Medicine and Gerontology, 2024 East Monument Street, Johns Hopkins University, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center on Aging and Health, Division of Geriatric Medicine and Gerontology, 2024 East Monument Street, Johns Hopkins University, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, 1601 Cherry Street, Mail Stop 10501, Drexel University, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Gaugler', 'Affiliation': 'Division of Health Policy and Management, School of Public Health, 420 Delaware St. SE, University of Minnesota, Minneapolis, MN, 55455, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100628']
3028,32833935,Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.,"BACKGROUND


African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.
OBJECTIVE


The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.
RESEARCH DESIGN


Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.
MEASURES


The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.
RESULTS


Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
CONCLUSION


A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.",2020,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","['African Americans and non-African Americans with diabetes', 'African Americans than non-African Americans', 'Slow Diabetic Kidney Disease', 'Primary care patients (N=281, 56% African American', 'African Americans']","['multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control', 'Multifactorial Telehealth Intervention', 'multifactorial telehealth intervention']","['preservation of eGFR', 'kidney function', 'estimated glomerular filtration rate (eGFR']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.068358,"For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'Clarissa J', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Department of Population Health Sciences.'}, {'ForeName': 'Clemontina A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Oakes', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Pendergast', 'Affiliation': 'Biostatistics and Bioinformatics.'}, {'ForeName': 'Uptal D', 'Initials': 'UD', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Nephrology, Duke University School of Medicine.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT).'}]",Medical care,['10.1097/MLR.0000000000001387']
3029,31578168,"Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study.","BACKGROUND


Transbronchial lung cryobiopsy (TBLC) is a novel technique for sampling lung tissue for interstitial lung disease diagnosis. The aim of this study was to establish the diagnostic accuracy of TBLC compared with surgical lung biopsy (SLB), in the context of increasing use of TBLC in clinical practice as a less invasive biopsy technique.
METHODS


COLDICE was a prospective, multicentre, diagnostic accuracy study investigating diagnostic agreement between TBLC and SLB, across nine Australian tertiary hospitals. Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation. After screening at a centralised multidisciplinary discussion (MDD), patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic. Each tissue sample was assigned a number between 1 and 130, allocated in a computer-generated random sequence. Encoded biopsy samples were then analysed by masked pathologists. At subsequent MDD, de-identified cases were discussed twice with either TBLC or SLB along with clinical and radiological data, in random non-consecutive order. Co-primary endpoints were agreement of histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis; and for agreement of consensus clinical diagnosis using TBLC and SLB at MDD. Concordance and κ values were calculated for each primary endpoint. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12615000718549.
FINDINGS


Between March 15, 2016, and April 15, 2019, we enrolled 65 patients (31 [48%] men, 34 [52%] women; mean age 66·1 years [SD 9·3]; forced vital capacity 83·7% [SD 14·2]; diffusing capacity for carbon monoxide 63·4% [SD 12·8]). TBLC (7·1 mm, SD 1·9) and SLB (46·5 mm, 14·9) samples were each taken from two separate ipsilateral lobes. Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78). For TBLC with high or definite diagnostic confidence at MDD (39 [60%] of 65 cases), 37 (95%) were concordant with SLB diagnoses. In the 26 (40%) of 65 cases with low-confidence or unclassifiable TBLC diagnoses, SLB reclassified six (23%) to alternative high-confidence or definite MDD diagnoses. Mild-moderate airway bleeding occurred in 14 (22%) patients due to TBLC. The 90-day mortality was 2% (one of 65 patients), following acute exacerbation of idiopathic pulmonary fibrosis.
INTERPRETATION


High levels of agreement between TBLC and SLB for both histopathological interpretation and MDD diagnoses were shown. The TBLC MDD diagnoses made with high confidence were particularly reliable, showing excellent concordance with SLB MDD diagnoses. These data support the clinical utility of TBLC in interstitial lung disease diagnostic algorithms. Further studies investigating the safety profile of TBLC are needed.
FUNDING


University of Sydney, Hunter Medical Research Institute, Erbe Elektromedizin, Medtronic, Cook Medical, Rymed, Karl-Storz, Zeiss, and Olympus.",2020,"Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78).","['interstitial lung disease diagnosis (COLDICE', 'Between March 15, 2016, and April 15, 2019', 'Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation', 'enrolled 65 patients (31 [48%] men, 34 [52%] women', 'patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic', 'nine Australian tertiary hospitals']","['TBLC or SLB', 'Transbronchial lung cryobiopsy (TBLC', 'transbronchial lung cryobiopsy', 'TBLC and SLB', 'surgical lung biopsy (SLB', 'TBLC']","['Concordance and κ values', 'histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis', 'Histopathological agreement between TBLC and SLB', 'Mild-moderate airway bleeding', '90-day mortality']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",65.0,0.0467771,"Histopathological agreement between TBLC and SLB was 70·8% (weighted κ 0·70, 95% CI 0·55-0·86); diagnostic agreement at MDD was 76·9% (κ 0·62, 0·47-0·78).","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Troy', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia. Electronic address: ltroy@med.usyd.edu.au.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Grainge', 'Affiliation': 'John Hunter Hospital, New Lambton Heights, NSW, Australia; Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Williamson', 'Affiliation': 'Liverpool Hospital, Liverpool, NSW, Australia; Macquarie University Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Vallely', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Macquarie University Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Cooper', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Annabelle', 'Initials': 'A', 'LastName': 'Mahar', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Myers', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbour, MI, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Mulyadi', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Phillips', 'Affiliation': 'Macquarie University Hospital, Sydney, NSW, Australia; Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Jo', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Susanne E', 'Initials': 'SE', 'LastName': 'Webster', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Qi T', 'Initials': 'QT', 'LastName': 'Lin', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Rhodes', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Salamonsen', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Wrobel', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia; University of Notre Dame Australia, Fremantle, WA, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harris', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, NSW, Australia; Royal North Shore Hospital, Artarmon, NSW, Australia.'}, {'ForeName': 'Garrick', 'Initials': 'G', 'LastName': 'Don', 'Affiliation': 'Royal North Shore Hospital, Artarmon, NSW, Australia.'}, {'ForeName': 'Peter J C', 'Initials': 'PJC', 'LastName': 'Wu', 'Affiliation': 'Westmead Hospital, Westmead, NSW, Australia.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ng', 'Affiliation': 'Nepean Hospital, Kingswood, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Oldmeadow', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Edmund M T', 'Initials': 'EMT', 'LastName': 'Lau', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30342-X']
3030,32847776,Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial.,"OBJECTIVE


Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined.
DESIGN


A parallel, randomized, placebo-controlled trial.
SETTING


Tertiary level oncology center.
PATIENTS


88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited.
INTERVENTION


Participants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet.
MEASUREMENTS


The primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured.
RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
CONCLUSION


Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects.
TRIAL REGISTRATION


The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.",2020,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","['88 female patients with breast cancer', 'patients undergoing modified radical mastectomy', 'Tertiary level oncology center']","['Duloxetine', 'modified radical mastectomy (MRM) with ASA class', '2\xa0h preoperatively, placebo', 'Duloxetine 30\xa0mg (D30, N\xa0=\xa022), Duloxetine 60\xa0mg (D60, N\xa0=\xa022) and Duloxetine 90\xa0mg (D90, N\xa0=\xa022) tablet', 'placebo', 'morphine', 'Preoperative Duloxetine']","['level of sedation', 'analgesic efficacy and side effects', '24\xa0h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting', 'vomiting', 'median (IQR) consumption', 'acute pain and quality of recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1616501', 'cui_str': 'duloxetine 30 MG [Cymbalta]'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",88.0,0.273346,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Medical Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: Helal.hetta@uc.edu.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110007']
3031,32852361,Brief Report: Cessation of Long-Term Cotrimoxazole Prophylaxis in HIV-Infected Children Does Not Alter the Carriage of Antimicrobial Resistance Genes.,"BACKGROUND


Cotrimoxazole (CTX) is a broad-spectrum antimicrobial, combining trimethoprim and sulfamethoxazole. CTX prophylaxis reduces mortality and morbidity among people living with HIV in regions with high prevalence of bacterial infections and malaria. The Antiretroviral research for Watoto trial evaluated the effect of stopping versus continuing CTX prophylaxis in sub-Saharan Africa.
METHODS


In this study, 72 HIV-infected Zimbabwean children, on antiretroviral therapy, provided fecal samples at 84 and 96 weeks after randomization to continue or stop CTX. DNA was extracted for whole metagenome shotgun sequencing, with sequencing reads mapped to the Comprehensive Antibiotic Resistance Database to identify CTX and other antimicrobial resistance genes.
RESULTS


There were minimal differences in the carriage of CTX resistance genes between groups. The dfrA1 gene, conferring trimethoprim resistance, was significantly higher in the continue group (P = 0.039) and the tetA(P) gene conferring resistance to tetracycline was significantly higher in the stop group (P = 0.013). CTX prophylaxis has a role in shaping the resistome; however, stopping prophylaxis does not decrease resistance gene abundance.
CONCLUSIONS


No differences were observed in resistance gene carriage between the stop and continue groups. The previously shown multi-faceted protective effects of CTX in antiretroviral research for Watoto trial clinical outcomes are not outweighed by the risk of multi-drug resistance gene selection due to prophylaxis. These findings are reassuring, given current recommendations for long-term CTX prophylaxis among children living with HIV in sub-Saharan Africa to decrease mortality and morbidity.",2020,"The dfrA1 gene, conferring trimethoprim resistance, was significantly higher in the continue group (p=0.039) and the tetA(P) gene conferring resistance to tetracycline was significantly higher in the stop group (p=0.013).","['people living with HIV in regions with high prevalence of bacterial infections and malaria', '72 HIV-infected Zimbabwean children, on antiretroviral therapy, provided fecal samples at 84- and 96-weeks after randomization to continue or stop CTX', 'HIV-infected children']","['CTX prophylaxis', 'CTX', 'trimethoprim and sulfamethoxazole', 'Cotrimoxazole (CTX']","['carriage of antimicrobial resistance genes', 'tetA(P) gene conferring resistance to tetracycline', 'resistance gene carriage', 'mortality and morbidity', 'carriage of CTX resistance genes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]","[{'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0040976', 'cui_str': 'Trientine'}, {'cui': 'C0039649', 'cui_str': 'Tetracycline Resistance'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0041044', 'cui_str': 'sulfamethoxazole and trimethoprim'}]",72.0,0.114386,"The dfrA1 gene, conferring trimethoprim resistance, was significantly higher in the continue group (p=0.039) and the tetA(P) gene conferring resistance to tetracycline was significantly higher in the stop group (p=0.013).","[{'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Francis', 'Affiliation': 'Department of Medicine, Experimental Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ethan K', 'Initials': 'EK', 'LastName': 'Gough', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thaddeus J', 'Initials': 'TJ', 'LastName': 'Edens', 'Affiliation': ""Devil's Staircase Consulting, BC Centre for Disease Control, West Vancouver, British Columbia, Canada.""}, {'ForeName': 'Chipo', 'Initials': 'C', 'LastName': 'Berejena', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mutsawashe', 'Initials': 'M', 'LastName': 'Bwakura-Dangarembizi', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Shonhai', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Kusum J', 'Initials': 'KJ', 'LastName': 'Nathoo', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Glass', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Amee R', 'Initials': 'AR', 'LastName': 'Manges', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002489']
3032,32856530,Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement.,"Background Gait speed is a reliable measure of physical function and frailty in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). Slow gait speed pre-TAVR predicts worse clinical outcomes post-TAVR. The consequences of improved versus worsened physical function post-TAVR are unknown. Methods and Results The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial randomized high/extreme risk patients to receive a mechanically-expanded or self-expanding transcatheter heart valve. Of 874 patients who underwent TAVR, 576 with complete data at baseline and 1 year were included in this analysis. Slow gait speed in the 5-m walk test was defined as <0.83 m/s. A clinically meaningful improvement (≥0.1 m/s) in gait speed 1 year after TAVR occurred in 39% of patients, 35% exhibited no change, and 26% declined (≥0.1 m/s). Among groups defined by baseline/1-year post-TAVR gait speeds, 1- to 2-year mortality or hospitalization rates were as follows: 6.6% (normal/normal), 8.0% (slow/normal), 20.9% (normal/slow), and 21.5% (slow/slow). After adjustment, slow gait speed at 1 year (regardless of baseline speed) was associated with a 3.5-fold increase in death/hospitalization between 1 and 2 years compared with those with normal baseline/1-year gait speed. Patients whose slow gait speed normalized at 1 year had no increased risk. One-year, but not baseline, gait speed was associated with death or hospitalization between 1 and 2 years (adjusted hazard ratio, 0.83 per 0.1 m/s faster gait; 95% CI, 0.74-0.93,  P =0.001). Conclusions Marked heterogeneity exists in the trajectory of physical function after TAVR and this, more than baseline function, has clinical consequences. Identifying and optimizing factors associated with physical resilience after TAVR may improve outcomes. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02202434.",2020,"m/s faster gait; 95% CI, 0.74-0.93,  P =0.001).","['Patients Undergoing Transcatheter Aortic Valve Replacement', '874 patients who underwent TAVR, 576 with complete data at baseline and 1 year were included in this analysis', 'patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR']","['mechanically-expanded or self-expanding transcatheter heart valve', 'Registration URL']","['death or hospitalization', 'gait speed 1\xa0year after TAVR', 'slow gait speed normalized', 'slow gait speed', '2-year mortality or hospitalization rates', 'death/hospitalization', 'Slow gait speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",874.0,0.151714,"m/s faster gait; 95% CI, 0.74-0.93,  P =0.001).","[{'ForeName': 'Kashish', 'Initials': 'K', 'LastName': 'Goel', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': ""O'Leary"", 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Barker', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Levack', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rajagopal', 'Affiliation': 'Marcus Heart Valve Center Piedmont Heart Institute Atlanta GA.'}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars - Sinai Heart Institute Los Angeles CA.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Bajwa', 'Affiliation': ""Aurora Cardiovascular Services Aurora Sinai/Aurora St. Luke's Medical Centers Milwaukee WI.""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Kleiman', 'Affiliation': 'Department of Cardiovascular Surgery Houston Methodist DeBakey Heart and Vascular Center Houston TX.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Department of Internal Medicine and Cardiology Heart Center Dresden Technical University of Dresden Germany.'}, {'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center Lindner Research Center Cincinnati OH.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology MedStar Washington Hospital Center Washington DC.'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Allocco', 'Affiliation': 'Clinical Sciences Boston Scientific Corp Marlborough MA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Rizik', 'Affiliation': 'HonorHealth and the Scottsdale-Lincoln Health Network Scottsdale AZ.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Department of Cardiovascular Surgery Houston Methodist DeBakey Heart and Vascular Center Houston TX.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lindman', 'Affiliation': 'Structural Heart and Valve Center Vanderbilt University Medical Center Nashville TN.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017075']
3033,32859432,Prognostic value of a new staging system based on the retrieved number and metastatic rate of LNs in gastric cancer with ≤15 retrieved LNs.,"OBJECTIVE


To investigate a reasonable lymph node (N) staging system for gastric cancer patients with ≤15 retrieved lymph nodes (LNs).
METHODS


The clinicopathological and follow-up data of patients with ≤15 LNs were obtained from the US Surveillance, Epidemiology, and End Results (SEER) database to analyze the impact of the number of retrieved LNs and metastatic status on the prognosis. In addition, external validation was achieved with data from two medical centers in China.
RESULTS


A total of 18,139 gastric cancer patients with 1-15 retrieved LNs from the SEER database were enrolled and randomly divided into the training group and the internal validation group. A new LN staging system, mNr staging (mNr0-4; 5 stages), was established according to the number of retrieved LNs and the metastatic rate. Compared with the TNM and TNrM staging systems (established by Wang J; misclassification rates of 50.4% and 62.5%, respectively), the mTNrM staging system had a lower misclassification rate (23.4%). Furthermore, there was a significant difference in the 5-year overall survival (OS) rate between the mTNrM staging subgroups (p < 0.05); however, no significant difference was found in the 5-year OS rate of partial adjacent stages in the TNM (8th edition) and TNrM (p > 0.05) staging systems. Similar results were obtained in the external validation cohort.
CONCLUSION


mNr and mTNrM staging systems can efficiently distinguish a survival difference in patients who undergo gastrectomy with ≤15 retrieved LNs, with more accurate predictions of the 5-year OS rate of patients compared with the TNM and TNrM staging systems.",2020,"Compared with the TNM and TNrM staging systems (established by Wang J; misclassification rates of 50.4% and 62.5%, respectively), the mTNrM staging system had a lower misclassification rate (23.4%).","['18,139 gastric cancer patients with 1-15 retrieved LNs from the SEER database', 'gastric cancer patients with ≤15 retrieved lymph nodes (LNs', 'patients with ≤15 LNs', 'gastric cancer with ≤15 retrieved LNs']",[],"['5-year OS rate', 'misclassification rate', '5-year overall survival (OS) rate', '5-year OS rate of partial adjacent stages']","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",18139.0,0.0316253,"Compared with the TNM and TNrM staging systems (established by Wang J; misclassification rates of 50.4% and 62.5%, respectively), the mTNrM staging system had a lower misclassification rate (23.4%).","[{'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Caner Center, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China; Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Caner Center, Guangzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric and Pancreatic Surgery, Sun Yat-sen University Caner Center, Guangzhou, China. Electronic address: zhouzhw@sysucc.org.cn.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China. Electronic address: hcmlr2002@163.com.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China; Key Laboratory of Ministry of Education of Gastrointestinal Cancer, Fujian Medical University, Fuzhou, China. Electronic address: wwkzch@163.com.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.07.001']
3034,32860791,Effects of Diet-Modulated Autologous Fecal Microbiota Transplantation on Weight Regain.,"BACKGROUND & AIMS


We evaluated the efficacy and safety of diet-modulated autologous fecal microbiota transplantation (aFMT) for treatment of weight regain after the weight-loss phase.
METHODS


In the DIRECT PLUS (Dietary Intervention Randomized Controlled Trial Polyphenols-Unprocessed) weight-loss trial (May 2017 through July 2018), abdominally obese or dyslipidemic participants in Israel were randomly assigned to healthy dietary guidelines, Mediterranean diet, and green-Mediterranean diet weight-loss groups. All groups received free gym membership and physical activity guidelines. Both isocaloric Mediterranean groups consumed 28 g/d walnuts (+440 mg/d polyphenols provided). The green-Mediterranean dieters also consumed green tea (3-4 cups/d) and a Wolffia globosa (Mankai strain, 100 g/d) green shake (+800 mg/d polyphenols provided). After 6 months (weight-loss phase), 90 eligible participants (mean age, 52 years; mean weight loss, 8.3 kg) provided a fecal sample that was processed into aFMT by frozen, opaque, and odorless capsules. The participants were then randomly assigned to groups that received 100 capsules containing their own fecal microbiota or placebo until month 14. The primary outcome was regain of the lost weight over the expected weight-regain phase (months 6-14). Secondary outcomes were gastrointestinal symptoms, waist circumference, glycemic status, and changes in the gut microbiome, as measured by metagenomic sequencing and 16s ribosomal RNA. We validated the results in a parallel in vivo study of mice specifically fed with Mankai compared with control chow diet.
RESULTS


Of the 90 participants in the aFMT trial, 96% ingested at least 80 of 100 oral aFMT or placebo frozen capsules during the transplantation period. No aFMT-related adverse events or symptoms were observed. For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs placebo, 40.6%; P = .28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P = .02), but not in the dietary guidelines (P = .57) or Mediterranean diet (P = .64) groups (P for the interaction = .03). Accordingly, aFMT attenuated waist circumference gain (aFMT, 1.89 cm vs placebo, 5.05 cm; P = .01) and insulin rebound (aFMT, 1.46 ± 3.6 μIU/mL vs placebo, 1.64 ± 4.7 μIU/mL; P = .04) in the green-Mediterranean group but not in the dietary guidelines or Mediterranean diet (P for the interaction = .04 and .03, respectively). The green-Mediterranean diet was the only intervention to induce a significant change in microbiome composition during the weight-loss phase, and to prompt preservation of weight-loss-associated specific bacteria and microbial metabolic pathways (mainly microbial sugar transport) after the aFMT. In mice, Mankai-modulated aFMT in the weight-loss phase compared with control diet aFMT, significantly prevented weight regain and resulted in better glucose tolerance during a high-fat diet-induced regain phase (all, P < .05).
CONCLUSIONS


Autologous FMT, collected during the weight-loss phase and administrated in the regain phase, might preserve weight loss and glycemic control, and is associated with specific microbiome signatures. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure. ClinicalTrials.gov number, NCT03020186.",2020,"For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03).","['90 eligible participants (mean age, 52 years; mean weight loss, 8.3 kg) provided a fecal sample that was processed into aFMT by frozen, opaque and odorless capsules', 'Of the 90 participants in the aFMT trial, 96% ingested at least 80 of 100 oral', 'abdominally obese or dyslipidemic participants in Israel']","['aFMT or placebo', 'diet-modulated autologous fecal microbiota transplantation (aFMT', '100 capsules containing their own fecal microbiota or placebo', 'aFMT', 'Diet-Modulated Autologous Fecal Microbiota Transplantation', '1)healthy dietary guidelines, (2)Mediterranean diet, and (3)green-Mediterranean diet weight-loss groups', 'Mankai-modulated aFMT', 'High-polyphenols, green plant-based or Mankai diet']","['Weight Regain', 'aFMT attenuated waist circumference gain', 'regain of the lost weight over the expected weight regain phase', 'better glucose tolerance', 'weight regain', 'gastrointestinal symptoms, waist-circumference, glycemic status and changes in the gut microbiome, as measured by metagenomic sequencing and 16s-rRNA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}]",90.0,0.0688763,"For the primary outcome, although no significant differences in weight regain were observed among the participants in the different lifestyle interventions during months 6-14 (aFMT, 30.4% vs. placebo, 40.6%;P=.28), aFMT significantly attenuated weight regain in the green-Mediterranean group (aFMT, 17.1%, vs placebo, 50%; P=.02), but not in the dietary guidelines (P=.57) or Mediterranean diet (P=.64) groups (P for the interaction=.03).","[{'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Youngster', 'Affiliation': ""Pediatric Division and Center for Microbiome Research, Shamir Medical Center, Be'er Ya'akov, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: youngsteri@shamir.gov.il.""}, {'ForeName': 'Anat Yaskolka', 'Initials': 'AY', 'LastName': 'Meir', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'BioTechnology Institute, University of Minnesota, St Paul, Minnesota; Department of Computer Science and Engineering, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Tuohy', 'Affiliation': 'Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Trento, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fava', 'Affiliation': 'Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Trento, Italy.'}, {'ForeName': 'Matthias Uwe', 'Initials': 'MU', 'LastName': 'Scholz', 'Affiliation': 'Department of Food Quality and Nutrition, Research and Innovation Centre, Fondazione Edmund Mach, Trento, Italy.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ziv', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Reuven', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Tirosh', 'Affiliation': ""Division of Endocrinology, Diabetes and Metabolism, Sheba Medical Center, Tel-Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Rudich', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Blüher', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Medicine, University of Leipzig, German.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Clement', 'Affiliation': 'Sorbonne University/Inserm, NutriOmics Research Unit, Nutrition Department, Pitié-Salpêtrière Hospital, Assistance-Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Omry', 'Initials': 'O', 'LastName': 'Koren', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Safed, Israel.'}, {'ForeName': 'Dong D', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Cambridge, Massachusetts.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Cambridge, Massachusetts; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Meir J', 'Initials': 'MJ', 'LastName': 'Stampfer', 'Affiliation': ""Harvard T.H. Chan School of Public Health, Cambridge, Massachusetts; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Harvard T.H. Chan School of Public Health, Cambridge, Massachusetts. Electronic address: irish@bgu.ac.il.'}]",Gastroenterology,['10.1053/j.gastro.2020.08.041']
3035,32860843,Comparison of cardiac function between left bundle branch pacing and right ventricular outflow tract septal pacing in the short-term: A registered controlled clinical trial.,"BACKGROUND


The novel method of left bundle branch pacing (LBBP) has been reported to produce a narrower QRS duration and lower pacing threshold than right ventricular outflow tract septal pacing (RVOP). However, whether LBBP is superior to traditional RVOP in improving cardiac function still lacks sufficient evidence.
OBJECTIVE


The purpose of this study was to compare the changes in cardiac function (especially in brain natriuretic peptide (BNP)levels, left atrial function, and left ventricular diastolic function) within 7 days between LBBP and RVOP.
METHODS AND RESULTS


A single-centre prospective controlled registered clinical study was conducted with 84 patients with bradycardia indications. Forty-two patients underwent RVOP, and 42 patients underwent LBBP. The pacemaker parameters were adjusted so that the ventricular ratio was over 90% and rate was 60-70 bpm. The changes in BNP levels and echocardiogram and speckle-tracking echocardiagraphy findings were compared between the two groups before and within 7 days after implantation: (1) BNP: there was no significant difference in BNP level between the two groups before and 1 day after implantation, while the LBBP group had significantly lower levels than the RVOP group on day 7 [(65.15 ± 56.96)pg/ml vs.(129.82 ± 101.92)pg/ml, P < 0.001]. (2) Cardiac echocardiography: the e' value of the LBBP group was higher than that of the RVOP group 7 days after implantation[(6.39 ± 2.65) cm/s vs. (5.45 ± 1.35)cm/s, P = 0.049]. The E/e' and peak E-wave velocity in the LBBP group decreased significantly after 7 days [16.57 ± 6.55 vs. 12.75 ± 5.16 P = 0.043, (88.6 ± 24.37)cm/s vs. (75.68 ± 28.10)cm/s P = 0.030]; in contrast, there were no significant changes in the RVOP group [14.13 ± 3.85 vs.14.10 ± 4.85 P = 0.50, (77.33 ± 21.14)cm/s vs. (74.45 ± 23.03)cm/s P = 0.56). (3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
CONCLUSION


This study demonstrates that compared to RVOP, LBBP can increase left ventricular early diastolic function, improve BNP levels, and has a tendency to increase left atrial myocardial elasticity and left atrial strain capacity in the short term in pacemaker-dependent patients.",2021,"(3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
",['84 patients with bradycardia indications'],"['left bundle branch pacing (LBBP', 'RVOP', 'RVOP, LBBP', 'LBBP', 'left bundle branch pacing and right ventricular outflow tract septal pacing']","['peak E-wave velocity', 'ventricular ratio', 'BNP level', 'left atrial myocardial elasticity and left atrial strain capacity', 'brain natriuretic peptide (BNP)levels, left atrial function, and left ventricular diastolic function', 'BNP levels and echocardiogram and speckle-tracking echocardiagraphy findings', 'left atrial strain or the strain rate', 'absolute values of left atrial strain and strain rate', 'cardiac function', 'left ventricular early diastolic function, improve BNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0459156', 'cui_str': 'Left bundle branch structure'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0225892', 'cui_str': 'Structure of outflow tract of right ventricle'}, {'cui': 'C0442004', 'cui_str': 'Septal'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0078995', 'cui_str': 'Left Atrial Function'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",84.0,0.0197044,"(3)Speckle-tracking echocardiagraphy: there was no significant difference in left atrial strain or the strain rate between the LBBP and RVOP groups，but the absolute values of left atrial strain and strain rate in the LBBP group increased, while those in the RVOP group decreased.
","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Bolun', 'Affiliation': ""Xiangya School of Medicine, Central South University, Changsha, People's Republic of China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Pei', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Bofei', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Qiaoli', 'Initials': 'Q', 'LastName': 'Tong', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Hongning', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'You', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ruiqin', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': ""Division of cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China. Electronic address: 13230178060@163.com.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.08.048']
3036,32860912,"Comment on ""Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma: One-year results of a noninferiority, randomized, controlled trial"".",,2020,,['nodular basal cell carcinoma'],['Surgery versus combined treatment with curettage and imiquimod'],[],"[{'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}]",[],,0.0793506,,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pitney', 'Affiliation': 'Mater Hospital, Brisbane, Australia. Electronic address: pitneythomas@gmail.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Muir', 'Affiliation': 'Mater Hospital, Brisbane, Australia.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.08.093']
3037,32866454,"An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.","BACKGROUND


Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.
HYPOTHESIS


Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies.
DESIGN


The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy.
SUMMARY


The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.",2020,"The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing.","['Study enrollment was completed January 2020, with a total 305 patients', 'chronic heart failure with reduced ejection fraction', 'Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient']","['activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits', 'EPIC-HF intervention']",[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0376458,"The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing.","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Venechuk', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Prateeti', 'Initials': 'P', 'LastName': 'Khazanie', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Page', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Jocelyn S', 'Initials': 'JS', 'LastName': 'Thompson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Strader', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'Tristan J', 'Initials': 'TJ', 'LastName': 'Dow', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Katy E', 'Initials': 'KE', 'LastName': 'Trinkley', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'McIlvennan', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Magid', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Buttrick', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO. Electronic address: larry.allen@cuanschutz.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.013']
3038,32830553,Hyperglycemia does not Inhibit Insulin's Effects on Microvascular Perfusion in Healthy Humans: A Randomized Crossover Study.,"Diabetes mellitus accelerates vascular disease through multiple biochemical pathways driven by hyperglycemia, with insulin resistance and/or hyperinsulinemia also contributing. Persons with diabetes mellitus experience premature large vessel and microvascular disease when compared to normoglycemic controls. Currently there is a paucity of clinical data identifying how acutely the vasculature responds to hyperglycemia and whether other physiologic factors (e.g., vasoactive hormones) contribute. To our knowledge, no prior studies have examined the dynamic effects of acute hyperglycemia on insulin-mediated actions on both micro- and macrovascular function in the same subjects. In this randomized crossover trial, healthy young adults underwent two infusion protocols designed to compare the effects of insulin infusion during euglycemia and hyperglycemia on micro- and macrovascular function. Both euglycemic- and hyperglycemic-hyperinsulinemia increased skeletal (but not cardiac) muscle microvascular blood volume (each p<0.02) and blood flow significantly (each p<0.04), and these increases did not differ between protocols. Hyperglycemic-hyperinsulinemia trended towards increased carotid-femoral pulse wave velocity (indicating increased aortic stiffness; p= 0.065 after Bonferroni adjustment), while euglycemic-hyperinsulinemia did not. There were no changes in post-ischemic flow velocity or brachial artery flow-mediated dilation during either protocol. Plasma endothelin-1 levels significantly decreased during both protocols (each p<0.02). In this study, acute hyperglycemia for 4 hours did not inhibit insulin's ability to increase skeletal muscle microvascular perfusion but did provoke a slight increase in aortic stiffness. Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.",2020,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"['healthy young adults', 'Persons with diabetes mellitus', 'Healthy Humans']",['insulin infusion during euglycemia and hyperglycemia'],"['blood flow', 'myocardial microvascular perfusion or endothelial function', 'Hyperglycemia', 'Plasma endothelin-1 levels', 'cardiac) muscle microvascular blood volume', 'euglycemic-hyperinsulinemia', 'post-ischemic flow velocity or brachial artery flow-mediated dilation', 'aortic stiffness', 'Hyperglycemic-hyperinsulinemia', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",,0.0219329,Hyperglycemia also did not adversely affect myocardial microvascular perfusion or endothelial function or prevent the decline of endothelin-1 during insulin infusion.,"[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Horton', 'Affiliation': 'Medicine, University of Virginia, United States.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Jahn', 'Affiliation': 'endocrinology, University of Virginia, United States.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Hartline', 'Affiliation': 'University of Virginia, United States.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Aylor', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Patrie', 'Affiliation': 'Public Health Sciences, University of Virginia Medical Center, United States.'}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Barrett', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Department of Pharmacology , University of Virginia, School of Medicine, Charlottesville, VA 22908; Department of Molecular and Clinical Medicine (, United States.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00300.2020']
3039,32836201,Development and validation of a nomogram for predicting survival of advanced breast cancer patients in China.,"BACKGROUND


There is a lack of prognostic models predicting the overall survival (OS) of advanced breast cancer (ABC) patients in China.
METHODS


Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants were enrolled in this study, which were further randomized 3:1 and divided into training (n = 1706) and validation (n = 557) groups. The nomogram was built based on independent predictors identified by univariate and multivariate cox regression analyses. The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
RESULTS


Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) score, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly related to OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) for the training set and 0.686 (95% CI: 0.652-0.719) for the validation set. The calibration curves revealed satisfactory consistency between actual survival and nomogram prediction in both the internal and external validations. The nomogram was capable of stratifying patients into different risk cohorts.
CONCLUSIONS


We constructed and validated a nomogram that might serve as an efficient tool to provide prognostic prediction for ABC patients and guide the physicians to make personalized treatment decisions.",2020,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","['advanced breast cancer patients in China', 'Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants', 'advanced breast cancer (ABC) patients in China']",[],['overall survival (OS'],"[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0456591', 'cui_str': '1987'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",4039.0,0.0279926,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","[{'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Hongnan', 'Initials': 'H', 'LastName': 'Mo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China. Electronic address: xubinghe@medmail.com.cn.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.004']
3040,32835925,Efficacy of donepezil for the attenuation of memory deficits associated with electroconvulsive therapy.,"We sought to confirm and extend the findings of studies that reported that acetylcholinesterase inhibitor drugs protect against electroconvulsive therapy (ECT)-induced cognitive impairment. We randomized 30 patients with depression (n=24) or schizophrenia (n=6) to receive either donepezil (10 mg/day; n=15) or placebo (n=15) during a fixed course of 6 thrice-weekly, modified, bifrontotemporal sine wave ECT, and for 30 days subsequently. We assessed memory using the Postgraduate Institute Memory Scale (PGI-MS) at baseline, and again at days 2, 7, and 30 after the ECT course. At baseline, memory functioning was comparable in the 2 groups. At 2 days post-ECT, memory functioning was impaired on almost all 10 subtests and on the total scale. At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself. There was no significant difference between groups in the primary outcome, improvement in PGI-MS scores between Days 2 and 30 post-ECT. On almost all subtests, also, there was no significant difference between groups. In summary, we found that donepezil (10 mg/day) did not improve memory outcomes after ECT.",2020,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.",['30 patients with depression (n=24) or schizophrenia (n=6) to receive either'],"['donepezil', 'placebo', 'electroconvulsive therapy']","['Postgraduate Institute Memory Scale (PGI-MS', 'memory outcomes', 'PGI-MS scores', 'memory functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.109804,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.","[{'ForeName': 'Lt Col Bikram', 'Initials': 'LCB', 'LastName': 'Dutta', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'Col Pradyot', 'Initials': 'CP', 'LastName': 'Sarkar', 'Affiliation': 'Ohio Hospital, New Town, Kolkata, India. Electronic address: colpsarkar@live.com.'}, {'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': 'Dean (Basic Sciences), Department of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore 560 029, India. Electronic address: andradec@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113397']
3041,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2021,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
3042,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
3043,32844328,Effects of Dating Matters® on Sexual Violence and Sexual Harassment Outcomes among Middle School Youth: a Cluster-Randomized Controlled Trial.,"Sexual violence (SV), including sexual harassment (SH), is a significant public health problem affecting adolescent health and well-being. This study extends prior research by evaluating the effectiveness of a comprehensive teen dating violence prevention model, Dating Matters, on SV and SH perpetration and victimization, inclusive of any victim-perpetrator relationship, among middle school students. Dating Matters includes classroom-delivered programs for youth in 6th, 7th, and 8th grades; community-based programs for parents; a youth communications program; training for educators; and community-level activities. Middle schools in four urban areas in the USA were randomly assigned to receive Dating Matters (DM, N = 22) or a standard-of-care intervention (SC, N = 24) over four consecutive school years (2012-2016). The analytic sample included two cohorts who entered the study in 6th grade and completed 8th grade by the end of the study allowing for full exposure to Dating Matters (DM: N = 1662; SC: N = 1639; 53% female; 50% black, non-Hispanic; 6 waves of data collection for each cohort). Structural equation modeling was employed with multiple imputation to account for missing data. Dating Matters was associated with significant reductions in SV and SH perpetration and victimization scores in most-but not all-sex/cohort groups by the end of 8th grade relative to an evidence-based TDV prevention program. On average, students receiving Dating Matters scored 6% lower on SV perpetration, 3% lower on SV victimization, 4% lower on SH perpetration, and 8% lower on SH victimization by the end of middle school than students receiving an evidence-based violence prevention program. Overall, Dating Matters shows promise for reducing SV and SH, occurring both within and outside dating relationships, through middle school. Clinicaltrials.gov Identifier: NCT01672541.",2020,Dating Matters was associated with significant reductions in SV and SH perpetration and victimization scores in most-but not all-sex/cohort groups by the end of 8th grade relative to an evidence-based TDV prevention program.,"['SC: N\u2009=\u20091639; 53% female; 50% black, non-Hispanic; 6 waves of data collection for each cohort', 'analytic sample included two cohorts who entered the study in 6th grade and completed 8th grade by the end of the study allowing for full exposure to Dating Matters', 'Middle schools in four urban areas in the USA', 'Middle School Youth', 'DM: N\u2009=\u20091662', 'middle school students']","['Dating Matters (DM, N\u2009=\u200922) or a standard-of-care intervention (SC, N\u2009=\u200924) over four consecutive school years', 'Dating Matters®']","['Sexual violence (SV), including sexual harassment (SH', 'SH victimization', 'SV and SH perpetration and victimization scores', 'Sexual Violence and Sexual Harassment Outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162790', 'cui_str': 'Sexual harassment'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0272559,Dating Matters was associated with significant reductions in SV and SH perpetration and victimization scores in most-but not all-sex/cohort groups by the end of 8th grade relative to an evidence-based TDV prevention program.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'DeGue', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA. sdegue@cdc.gov.'}, {'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Lianne Fuino', 'Initials': 'LF', 'LastName': 'Estefan', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Tracy', 'Affiliation': '2M Research, LLC, Arlington, TX, USA.'}, {'ForeName': 'Vi D', 'Initials': 'VD', 'LastName': 'Le', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Vivolo-Kantor', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Natasha E', 'Initials': 'NE', 'LastName': 'Latzman', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Tharp', 'Affiliation': 'Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F63, Atlanta, GA, 30341, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Lang', 'Affiliation': 'Institute for Measurement, Methodology, Analysis and Policy, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': 'NORC at the University of Chicago, Chicago, IL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01152-0']
3044,32843527,PIK3CA  Mutation in the ShortHER Randomized Adjuvant Trial for Patients with Early HER2 +  Breast Cancer: Association with Prognosis and Integration with PAM50 Subtype.,"PURPOSE


We explored the prognostic effect of  PIK3CA  mutation in HER2 +  patients enrolled in the ShortHER trial.
PATIENTS AND METHODS


The ShortHER trial randomized 1,253 patients with HER2 +  breast cancer to 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy.  PIK3CA  hotspot mutations in exon 9 and 20 were analyzed by pyrosequencing. Expression of 60 genes, including PAM50 genes was measured using the nCounter platform.
RESULTS


A mutation of the  PIK3CA  gene was detected in 21.7% of the 803 genotyped tumors. At a median follow-up of 7.7 years, 5-year disease-free survival (DFS) rates were 90.6% for  PIK3CA  mutated and 86.2% for  PIK3CA  wild-type tumors [HR, 0.84; 95% confidence interval (CI), 0.56-1.27;  P  = 0.417].  PIK3CA  mutation showed a favorable prognostic impact in the PAM50 HER2-enriched subtype ( n  = 232): 5-year DFS 91.8% versus 76.1% (log-rank  P  = 0.049; HR, 0.46; 95% CI, 0.21-1.02). HER2-enriched/ PIK3CA  mutated versus wild-type tumors showed numerically higher tumor-infiltrating lymphocytes (TIL) and significant upregulation of immune-related genes (including  CD8A, CD274, PDCD1,  and  MYBL2 , a proliferation gene involved in immune processes). High TILs as well as the upregulation of  PDCD1  and  MYBL2  were associated with a significant DFS improvement within the HER2-enriched subtype (HR, 0.82; 95% CI, 0.68-0.99;  P  = 0.039 for 10% TILs increment; HR, 0.81; 95% CI, 0.65-0.99;  P  = 0.049 for  PDCD1  expression; HR, 0.72; 95% CI, 0.53-0.99;  P  = 0.042 for  MYBL2  expression).
CONCLUSIONS


PIK3CA  mutation showed no prognostic impact in the ShortHER trial. Within the HER2-enriched molecular subtype, patients with  PIK3CA  mutated tumors showed better DFS versus  PIK3CA  wild-type, which may be partly explained by upregulation of immune-related genes.",2020,"High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
","['HER2-positive patients enrolled in the ShortHER trial', 'patients with early HER2+ breast cancer', '1253 patients with HER2-positive breast cancer to 9-weeks or 1-year of adjuvant']","['PIK3CA', 'trastuzumab combined with chemotherapy']","['5-yr disease-free survival (DFS) rates', 'Expression of 60 genes, including PAM50 genes', 'tumor infiltrating lymphocytes (TILs) and significant upregulation of immune-related genes (including CD8A, CD274, PDCD1 and MYBL2, a proliferation gene involved in immune processes']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0135710', 'cui_str': 'PDCD1 protein, human'}, {'cui': 'C1505106', 'cui_str': 'MYBL2 protein, human'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",1253.0,0.164005,"High TILs as well as the upregulation of PDCD1 and MYBL2 were associated with a significant DFS improvement within the HER2-enriched subtype (HR 0.82, 95%CI 0.68-0.99, P=0.039 for 10% TILs increment; HR 0.81, 95%CI 0.65-0.99, P=0.049 for PDCD1 expression; HR 0.72, 95%CI 0.53-0.99, P=0.042 for MYBL2 expression).
","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Dieci', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy. mariavittoria.dieci@unipd.it.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Bisagni', 'Affiliation': 'Department of Oncology and Advanced Technologies, Reggio Emilia, Italy.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'Medical Oncology, Azienda Unità Sanitaria Locale di Bologna-IRCCS Istituto delle Scienze Neurologiche, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Frassoldati', 'Affiliation': 'Clinical Oncology, Department of Morphology, Surgery and Experimental Medicine, S Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cavanna', 'Affiliation': 'Department of Oncology-Hematology, G. da Saliceto Hospital, Piacenza, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Musolino', 'Affiliation': 'Medical Oncology and Breast Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'IRCCS Istituto Tumori ""Giovanni Paolo II"" di Bari, Parma, Italy.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Rimanti', 'Affiliation': 'Medical Oncology, Azienda Ospedaliera di Mantova, Mantova, Italy.'}, {'ForeName': 'Ornella', 'Initials': 'O', 'LastName': 'Garrone', 'Affiliation': 'Breast Unit, Medical Oncology, A.O.S. Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bertone', 'Affiliation': 'Department of Gynecology and Obstetrics, Ospedale S. Anna, Turin, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Cagossi', 'Affiliation': 'Breast Unit Ausl Modena, Ramazzini Hospital, Carpi, Italy.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Piacentini', 'Affiliation': 'Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Orvieto', 'Affiliation': 'Pathology Unit, Rovigo, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Griguolo', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Curtarello', 'Affiliation': 'Immunology and Molecular Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Urso', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Chic', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Department of Medical and Surgical Sciences for Children & Adults, University of Modena, Modena, Italy.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Pierfranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1731']
3045,32844185,Newborn micronutrient status biomarkers in a cluster-randomized trial of antenatal multiple micronutrient compared with iron folic acid supplementation in rural Bangladesh.,"BACKGROUND


Daily antenatal multiple micronutrient (MM) compared with iron folic acid (IFA) supplementation from early pregnancy improved birth outcomes and maternal micronutrient status in rural Bangladesh, but effects on newborn status are unknown.
OBJECTIVE


We examined cord blood micronutrient biomarkers in relation to antenatal MM and IFA supplementation and maternal gestational micronutrient status in rural Bangladeshi newborns.
DESIGN


In a double-blinded, cluster-randomized trial of antenatal IFA or MM (with the same IFA content), we analyzed cord blood plasma from 333 singleton births, and corresponding maternal plasma at 32.5 ± 2.6 wk of gestation, for ferritin (iron stores), folate, cobalamin (vitamin B-12), retinol (vitamin A), 25-hydroxyvitamin D [25(OH)D, vitamin D status], α-tocopherol (vitamin E), zinc, thyroglobulin, and free thyroxine (iodine status). Intervention effects and associations were determined using linear regression, exploring maternal status as a mediator of intervention effects on cord biomarkers.
RESULTS


The MM intervention increased cord ferritin (mean: +12.4%; 95% CI: 1.3, 24.6%), 25(OH)D (mean: +14.7%; 95% CI: 4.8, 25.6%), and zinc (mean: +5.8%; 95% CI: 1.0, 10.8%). Cord folate (mean: +26.8%; 95% CI: 19.6, 34.5%), cobalamin (mean: +31.3%; 95% CI: 24.6, 38.3%), 25(OH)D (mean: +26.7%; 95% CI: 23.2, 30.3%), α-tocopherol (mean: +8.7%; 95% CI: 3.6, 13.7%), zinc (mean: +2.3%; 95% CI: 0.5, 4.2%), thyroglobulin (mean: +20.1%; 95% CI: 9.0, 32.2%) and thyroxine (mean: +1.5%; 95% CI: 0.0, 3.0%) increased per 1-SD increment in maternal status (all P < 0.05); ferritin and retinol changed by +2.0%; 95% CI: -8.9, 14.3%; P = 0.72; and +3.5%; 95% CI: -0.4, 7.3%; P = 0.07, respectively. Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.
CONCLUSIONS


Antenatal MM supplementation increased newborn ferritin, 25(OH)D, and zinc, while maternal and newborn folate, vitamins B-12, D, and E, zinc, and iodine biomarkers were positively related. Despite limited effects of MM, better maternal micronutrient status was associated with improved micronutrient status of Bangladeshi newborns. This trial was registered at clinicaltrials.gov as NCT00860470.",2020,"Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.
","['rural Bangladeshi newborns', 'rural Bangladesh']","['antenatal IFA or MM', 'Daily antenatal multiple micronutrient (MM) compared with iron folic acid (IFA) supplementation', 'IFA supplementation', 'antenatal multiple micronutrient compared with iron folic acid supplementation']","['newborn ferritin, 25(OH)D, and zinc, while maternal and newborn folate, vitamins B-12, D, and E, zinc, and iodine biomarkers', 'Cord folate', 'ferritin and retinol', 'Ferritin, folate, cobalamin, zinc, and thyroglobulin', 'cord ferritin', 'maternal gestational micronutrient status', ' 25-hydroxyvitamin D [25(OH)D, vitamin D status], α-tocopherol (vitamin E), zinc, thyroglobulin, and free thyroxine (iodine status', 'per 1-SD increment in maternal status', 'ferritin (iron stores), folate, cobalamin (vitamin B-12), retinol (vitamin A', 'α-tocopherol']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C1320396', 'cui_str': 'Maternal status'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}]",333.0,0.270589,"Ferritin, folate, cobalamin, zinc, and thyroglobulin averaged 1.57-6.75 times higher and retinol, α-tocopherol, and 25(OH)D 0.30-0.84 times lower in cord than maternal plasma, suggesting preferential maternal-fetal transfer of iron, folate, cobalamin, and zinc; limited transfer of fat-soluble vitamins; and high fetal iodine demand.
","[{'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Gernand', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Afreen Zaman', 'Initials': 'AZ', 'LastName': 'Khan', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lee S-F', 'Initials': 'LS', 'LastName': 'Wu', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'Mehra', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Abu Ahmed', 'Initials': 'AA', 'LastName': 'Shamim', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Pongtorn', 'Initials': 'P', 'LastName': 'Sungpuag', 'Affiliation': 'Institute of Nutrition, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Emorn', 'Initials': 'E', 'LastName': 'Udomkesmalee', 'Affiliation': 'Institute of Nutrition, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Alain B', 'Initials': 'AB', 'LastName': 'Labrique', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa223']
3046,32851921,Continuous Neuromuscular Blockade Following Successful Resuscitation From Cardiac Arrest: A Randomized Trial.,"Background Neuromuscular blockade (NMB) agents are often administered to control shivering during targeted temperature management following cardiac arrest. In this study, we hypothesized that early, continuous NMB would result in a greater reduction in serum lactate levels among comatose patients after cardiac arrest. Methods and Results Randomized trial of continuous NMB for 24 hours versus usual care following cardiac arrest conducted at 5 urban centers in the United States. Adult patients who achieved return of spontaneous circulation, remained unresponsive, and underwent targeted temperature management after cardiac arrest were included. The primary outcome was change in lactate over 24 hours. A total of 83 patients were randomized, and 80 were analyzed (37 and 43 in the NMB and usual care arms, respectively). There was no significant interaction between time and treatment group with respect to change in lactate over 24 hours (median lactate change from 4.2 to 2.0 mmol/L [-2.2 mmol/L] in the NMB arm versus 4.0 to 1.7 mmol/L [-2.3 mmol/L] in the usual care arm; geometric mean difference, 1.3 [95% CI, 1.0-1.8];  P =0.07 for the interaction term). There was no difference in hospital survival (38% [NMB] versus 33% [usual care];  P =0.63) or survival with good functional outcome (30% [NMB] versus 21% [usual care];  P =0.35). There were no adverse events in either arm attributed to study interventions. Conclusions Continuous NMB compared with usual care did not reduce lactate over the first 24 hours after enrollment compared with usual care. There was no difference in overall hospital survival, hospital survival with good neurologic outcome, or adverse events. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02260258.",2020,There was no difference in hospital survival (38% [NMB] versus 33% [usual care];  P =0.63) or survival with good functional outcome (30% [NMB] versus 21% [usual care];  P =0.35).,"['24 hours versus usual care following cardiac arrest conducted at 5 urban centers in the United States', 'A total of 83 patients were randomized, and 80 were analyzed (37 and 43 in the NMB and usual care arms, respectively', 'comatose patients after cardiac arrest', 'Cardiac Arrest', 'Adult patients who achieved return of spontaneous circulation, remained unresponsive, and underwent targeted temperature management after cardiac arrest were included']","['Continuous Neuromuscular Blockade', ' Neuromuscular blockade ', 'continuous NMB']","['change in lactate', 'serum lactate levels', 'adverse events', 'survival with good functional outcome', 'overall hospital survival, hospital survival with good neurologic outcome, or adverse events', 'lactate', 'hospital survival']","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0428446', 'cui_str': 'Serum lactate measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",83.0,0.137074,There was no difference in hospital survival (38% [NMB] versus 33% [usual care];  P =0.63) or survival with good functional outcome (30% [NMB] versus 21% [usual care];  P =0.35).,"[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Division of Pulmonary Critical Care, and Sleep Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Jon C', 'Initials': 'JC', 'LastName': 'Rittenberger', 'Affiliation': 'Department of Emergency Medicine Guthrie Robert Packer Hospital Sayre PA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Swor', 'Affiliation': 'Department of Emergency Medicine Beaumont Hospital, Royal Oak MI.'}, {'ForeName': 'Raghu R', 'Initials': 'RR', 'LastName': 'Seethala', 'Affiliation': ""Department of Emergency Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kurz', 'Affiliation': 'Department of Emergency Medicine University of Alabama School of Medicine Birmingham AL.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Berg', 'Affiliation': 'Division of Pulmonary Critical Care, and Sleep Medicine Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Cocchi', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Mathias J', 'Initials': 'MJ', 'LastName': 'Holmberg', 'Affiliation': 'Center for Resuscitation Science Beth Israel Deaconess Medical Center Boston MA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'Department of Emergency Medicine University of Pittsburgh PA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Division of Pulmonary Critical Care, and Sleep Medicine Beth Israel Deaconess Medical Center Boston MA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017171']
3047,32852904,Mepivacaine versus Bupivacaine Spinal Anesthesia for Early Postoperative Ambulation.,"BACKGROUND


Early ambulation after total hip arthroplasty predicts early discharge. Spinal anesthesia is preferred by many practices but can delay ambulation, especially with bupivacaine. Mepivacaine, an intermediate-acting local anesthetic, could enable earlier ambulation than bupivacaine. This study was designed to test the hypothesis that patients who received mepivacaine would ambulate earlier than those who received hyperbaric or isobaric bupivacaine for primary total hip arthroplasty.
METHODS


This randomized controlled trial included American Society of Anesthesiologists Physical Status I to III patients undergoing primary total hip arthroplasty. The patients were randomized 1:1:1 to 52.5 mg of mepivacaine, 11.25 mg of hyperbaric bupivacaine, or 12.5 mg of isobaric bupivacaine for spinal anesthesia. The primary outcome was ambulation between 3 and 3.5 h. Secondary outcomes included return of motor and sensory function, postoperative pain, opioid consumption, transient neurologic symptoms, urinary retention, intraoperative hypotension, intraoperative muscle tension, same-day discharge, length of stay, and 30-day readmissions.
RESULTS


Of 154 patients, 50 received mepivacaine, 53 received hyperbaric bupivacaine, and 51 received isobaric bupivacaine. Patient characteristics were similar among groups. For ambulation at 3 to 3.5 h, 35 of 50 (70.0%) of patients met this endpoint in the mepivacaine group, followed by 20 of 53 (37.7%) in the hyperbaric bupivacaine group, and 9 of 51 (17.6%) in the isobaric bupivacaine group (P < 0.001). Return of motor function occurred earlier with mepivacaine. Pain and opioid consumption were higher for mepivacaine patients in the early postoperative period only. For ambulatory status, 23 of 50 (46.0%) of mepivacaine, 13 of 53 (24.5%) of hyperbaric bupivacaine, and 11 of 51 (21.5%) of isobaric bupivacaine patients had same-day discharge (P = 0.014). Length of stay was shortest in mepivacaine patients. There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
CONCLUSIONS


Mepivacaine patients ambulated earlier and were more likely to be discharged the same day than both hyperbaric bupivacaine and isobaric bupivacaine patients. Mepivacaine could be beneficial for outpatient total hip arthroplasty candidates if spinal is the preferred anesthesia type.
EDITOR’S PERSPECTIVE


",2020,"There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
","['154 patients, 50 received', 'American Society of Anesthesiologists Physical Status I to III patients undergoing primary total hip arthroplasty', 'Early Postoperative Ambulation', 'for primary total hip arthroplasty', '154 patients, more individuals in the mepivacaine spinal group ambulated 3 to 3.5 h after injection than did individuals in either the']","['bupivacaine', 'mepivacaine, 11.25 mg of hyperbaric bupivacaine', 'isobaric bupivacaine', 'hyperbaric bupivacaine', 'Bupivacaine Spinal Anesthesia', 'isobaric or hyperbaric bupivacaine groupLikewise', 'mepivacaine', 'Mepivacaine', 'hyperbaric or isobaric bupivacaine']","['ambulation', 'return of motor and sensory function, postoperative pain, opioid consumption, transient neurologic symptoms, urinary retention, intraoperative hypotension, intraoperative muscle tension, same-day discharge, length of stay, and 30-day readmissions', 'transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness', 'same-day discharge', 'Length of stay', 'Pain and opioid consumption']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C4517532', 'cui_str': '11.25'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",154.0,0.121315,"There were no differences in transient neurologic symptoms, urinary retention, hypotension, muscle tension, or dizziness.
","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Schwenk', 'Affiliation': ''}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Kasper', 'Affiliation': ''}, {'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Smoker', 'Affiliation': ''}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Mendelson', 'Affiliation': ''}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Austin', 'Affiliation': ''}, {'ForeName': 'Scot A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hozack', 'Affiliation': ''}, {'ForeName': 'Alexa J', 'Initials': 'AJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Wahal', 'Affiliation': ''}, {'ForeName': 'Jaime L', 'Initials': 'JL', 'LastName': 'Baratta', 'Affiliation': ''}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Torjman', 'Affiliation': ''}, {'ForeName': 'Alyson C', 'Initials': 'AC', 'LastName': 'Nemeth', 'Affiliation': ''}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Czerwinski', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003480']
3048,32854145,BILITE: A Bayesian randomized phase II design for immunotherapy by jointly modeling the longitudinal immune response and time-to-event efficacy.,"Immunotherapy-treatments that target a patient's immune system-has attracted considerable attention in cancer research. Its recent success has led to generation of novel immunotherapeutic agents that need to be evaluated in clinical trials. Two unique features of immunotherapy are the immune response and the fact that some patients may achieve long-term durable response. In this article, we propose a two-arm Bayesian adaptive randomized phase II clinical trial design for immunotherapy that jointly models the longitudinal immune response and time-to-event efficacy (BILITE), with a fraction of patients assumed to be cured by the treatment. The longitudinal immune response is modeled using hierarchical nonlinear mixed-effects models with possibly different trajectory patterns for the cured and susceptible groups. Conditional on the immune response trajectory, the time-to-event efficacy data for patients in the susceptible group is modeled via a time-dependent Cox-type regression model. We quantify the desirability of the treatment using a utility function and propose a two-stage design to adaptively randomize patients to treatments and make treatment recommendations at the end of the trial. Simulation studies show that compared with a conventional design that ignores the immune response, BILITE yields superior operating characteristics in terms of the ability to identify promising agents and terminate the trial early for futility.",2020,"Simulation studies show that compared with a conventional design that ignores the immune response, BILITE yields superior operating characteristics in terms of the ability to identify promising agents and terminate the trial early for futility.",[],[],[],[],[],[],,0.0406347,"Simulation studies show that compared with a conventional design that ignores the immune response, BILITE yields superior operating characteristics in terms of the ability to identify promising agents and terminate the trial early for futility.","[{'ForeName': 'Beibei', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of Experimental Statistics, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Biostatistics, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}]",Statistics in medicine,['10.1002/sim.8733']
3049,32857060,An Image-Based Mobile Health App for Postdrainage Monitoring: Usability Study.,"BACKGROUND


The application of mobile health (mHealth) platforms to monitor recovery in the postdischarge period has increased in recent years. Despite widespread enthusiasm for mHealth, few studies have evaluated the usability and user experience of mHealth in patients with surgical drainage.
OBJECTIVE


Our objectives were to (1) develop an image-based smartphone app, SurgCare, for postdrainage monitoring and (2) determine the feasibility and clinical value of the use of SurgCare by patients with drainage.
METHODS


We enrolled 80 patients with biliary or peritoneal drainage in this study. A total of 50 patients were assigned to the SurgCare group, who recorded drainage monitoring data with the smartphone app; and 30 patients who manually recorded the data were assigned to the conventional group. The patients continued to record data until drain removal. The primary aim was to validate feasibility for the user, which was defined as the proportion of patients using each element of the system. Moreover, the secondary aim was to evaluate the association of compliance with SurgCare and the occurrence of unexpected events.
RESULTS


The average submission duration was 14.98 days, and the overall daily submission rate was 84.2%. The average system usability scale was 83.7 (SD 3.5). This system met the definition of ""definitely feasible"" in 34 patients, ""possibly feasible"" in 10 patients, and ""not feasible"" in 3 patients. We found that the occurrence rates of complications in the SurgCare group and the conventional group were 6% and 26%, respectively, with statistically significant differences P=.03. The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
CONCLUSIONS


Patients can learn to use a smartphone app for postdischarge drainage monitoring with high levels of user satisfaction. We also identified a high degree of compliance with app-based drainage-recording design features, which is an aspect of mHealth that can improve surgical care.",2020,"The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
","['patients with surgical drainage', 'patients with drainage', '50 patients were assigned to the SurgCare group, who recorded drainage monitoring data with the smartphone app; and 30 patients who manually recorded the data were assigned to the conventional group', '80 patients with biliary or peritoneal drainage in this study']",[],"['average submission duration', 'rate of unexpected hospital return', 'occurrence rates of complications', 'average system usability scale', 'overall daily submission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",80.0,0.040476,"The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
","[{'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Liao', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Yu-Tung', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chi-Tung', 'Initials': 'CT', 'LastName': 'Cheng', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chun-Hsiang', 'Initials': 'CH', 'LastName': 'Ooyang', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Shih-Ching', 'Initials': 'SC', 'LastName': 'Kang', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chih-Yuan', 'Initials': 'CY', 'LastName': 'Fu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Yu-Pao', 'Initials': 'YP', 'LastName': 'Hsu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chi-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chih-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}]",Journal of medical Internet research,['10.2196/17686']
3050,32860032,Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial.,"AIMS


Despite the effects of statins in reducing cardiovascular events and slowing progression of coronary atherosclerosis, significant cardiovascular (CV) risk remains. Icosapent ethyl (IPE), a highly purified eicosapentaenoic acid ethyl ester, added to a statin was shown to reduce initial CV events by 25% and total CV events by 32% in the REDUCE-IT trial, with the mechanisms of benefit not yet fully explained. The EVAPORATE trial sought to determine whether IPE 4 g/day, as an adjunct to diet and statin therapy, would result in a greater change from baseline in plaque volume, measured by serial multidetector computed tomography (MDCT), than placebo in statin-treated patients.
METHODS AND RESULTS


A total of 80 patients were enrolled in this randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis as documented by MDCT (one or more angiographic stenoses with ≥20% narrowing), be on statin therapy, and have persistently elevated triglyceride (TG) levels. Patients underwent an interim scan at 9 months and a final scan at 18 months with coronary computed tomographic angiography. The pre-specified primary endpoint was change in low-attenuation plaque (LAP) volume at 18 months between IPE and placebo groups. Baseline demographics, vitals, and laboratory results were not significantly different between the IPE and placebo groups; the median TG level was 259.1 ± 78.1 mg/dL. There was a significant reduction in the primary endpoint as IPE reduced LAP plaque volume by 17%, while in the placebo group LAP plaque volume more than doubled (+109%) (P = 0.0061). There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all). When further adjusted for age, sex, diabetes status, hypertension, and baseline TG, plaque volume changes between groups remained significantly different, P < 0.01. Only dense calcium did not show a significant difference between groups in multivariable modelling (P = 0.053).
CONCLUSIONS


Icosapent ethyl demonstrated significant regression of LAP volume on MDCT compared with placebo over 18 months. EVAPORATE provides important mechanistic data on plaque characteristics that may have relevance to the REDUCE-IT results and clinical use of IPE.",2020,"There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all).","['A total of 80 patients', 'patients with elevated triglycerides on statin therapy']","['coronary computed tomographic angiography', 'eicosapentaenoic acid ethyl ester', 'statins', 'Icosapent ethyl (IPE', 'placebo', 'MDCT', 'icosapent ethyl']","['elevated triglyceride (TG) levels', 'plaque volumes including fibrous, and fibrofatty (FF) plaque volumes', 'IPE reduced LAP plaque volume', 'LAP volume', 'low-attenuation plaque (LAP) volume', 'Baseline demographics, vitals, and laboratory results', 'initial CV events', 'coronary atherosclerosis', 'progression of coronary atherosclerosis', 'cardiovascular events', 'LAP plaque volume', 'rates of progression', 'median TG level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179130', 'cui_str': 'Multidetector-Row Computed Tomography'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}]",80.0,0.343818,"There were significant differences in rates of progression between IPE and placebo at study end involving other plaque volumes including fibrous, and fibrofatty (FF) plaque volumes which regressed in the IPE group and progressed in the placebo group (P < 0.01 for all).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Suvasini', 'Initials': 'S', 'LastName': 'Lakshmanan', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Muhlestein', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Viet T', 'Initials': 'VT', 'LastName': 'Le', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Heidi T', 'Initials': 'HT', 'LastName': 'May', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Chandana', 'Initials': 'C', 'LastName': 'Shekar', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Roy', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tayek', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, 1124 W Carson Street, Torrance, CA 90502, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Nelson', 'Affiliation': 'California Cardiovascular Institute, Fresno, CA, USA.'}]",European heart journal,['10.1093/eurheartj/ehaa652']
3051,32878963,"DUETTE: a phase II randomized, multicenter study to investigate the efficacy and tolerability of a second maintenance treatment in patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment.","BACKGROUND


With the success of poly(ADP-ribose) polymerase (PARP) inhibitor therapy in the first-line and second-line treatment settings, a new patient population is emerging with platinum-sensitive relapsed ovarian cancer, who have previously received a PARP inhibitor in the maintenance setting and for whom no second maintenance standard of care exists. DUETTE (NCT04239014) will evaluate the combination of ceralasertib (a potent, selective inhibitor of the serine/threonine kinase ataxia telangiectasia and Rad3-related protein (ATR) + olaparib, or olaparib monotherapy, compared with placebo, in this patient population of unmet need.
PRIMARY OBJECTIVE


The primary objective is to assess the efficacy of ceralasertib + olaparib combination, and olaparib monotherapy, compared with placebo, as second maintenance therapy in platinum-sensitive relapsed ovarian cancer.
STUDY HYPOTHESIS


This study will test the hypothesis that ceralasertib + olaparib, or olaparib monotherapy, is tolerable, and effective at prolonging progression-free survival compared with placebo.
TRIAL DESIGN


This is a phase II, multicenter study where patients will be randomized in a 1:1:1 ratio to receive either (Arm 1) ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo. The olaparib and placebo arms will be double-blinded, whereas the ceralasertib + olaparib arm will be open label. Patients will be stratified according to  BRCA  status, and response to platinum-based chemotherapy.
MAJOR INCLUSION/EXCLUSION CRITERIA


Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior PARP inhibitor maintenance therapy (a minimum of 12 months is required if the patient received PARP inhibitor maintenance following first-line chemotherapy). If the prior PARP inhibitor used was olaparib then patients must have received treatment without significant toxicity or the need for a permanent dose reduction. Disease relapse in the second-line or third-line setting is allowed. Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria.
PRIMARY ENDPOINTS


The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
SAMPLE SIZE


192 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


December 2022.
TRIAL REGISTRATION


NCT04239014.",2020,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
","['platinum-sensitive relapsed ovarian cancer', '192 patients', 'Eligible patients will have histologically diagnosed high-grade epithelial ovarian cancer, with platinum-sensitive relapse on, or after, completion of at least 6 months of any prior', 'Patients who have received secondary debulking surgery are potentially eligible if they meet all other inclusion criteria', 'patients with platinum-sensitive relapsed epithelial ovarian cancer, who have previously received poly(ADP-ribose) polymerase (PARP) inhibitor maintenance treatment', 'December 2022']","['olaparib and placebo', 'PARP inhibitor', 'Rad3-related protein (ATR) + olaparib, or olaparib monotherapy', 'poly(ADP-ribose) polymerase (PARP) inhibitor therapy', 'placebo', 'ceralasertib + olaparib, (Arm 2) olaparib monotherapy, or (Arm 3) placebo', 'PARP inhibitor maintenance therapy', 'ceralasertib + olaparib, or olaparib monotherapy', 'ceralasertib + olaparib combination, and olaparib monotherapy']","['progression-free survival', 'Disease relapse', 'efficacy and tolerability']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C3711837', 'cui_str': 'ATR protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.260806,"The primary endpoint is progression-free survival determined by blinded independent central review according to RECIST 1.1, with sensitivity analysis of progression-free survival using investigator assessments according to RECIST 1.1.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McMullen', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Karakasis', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Bienvenu', 'Initials': 'B', 'LastName': 'Loembe', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Graem', 'Initials': 'G', 'LastName': 'Parr', 'Affiliation': 'AstraZeneca R&D, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada amit.oza@uhn.ca.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001694']
3052,32883044,Physical Activity and Physical Competence in Overweight and Obese Children: An Intervention Study.,"With the current obesity epidemic and the decline of fitness among school-aged children, the importance of obesity interventions to promote physical activity and healthy habits has become indisputable. The purpose of this study was to assess the efficacy of a school-based multicomponent intervention in increasing physical activity (PA) levels, actual physical abilities, and perceived physical abilities in clinical and nonclinical samples of overweight/obese boys and girls aged 10-12 years. The clinical intervention group ( n  = 35) participated in a 7-month after-school program in addition to curricular physical education lessons, while the nonclinical control group ( n  = 29) received usual curricular lessons. Measures included levels of PA and fitness and individual's perceptions of physical ability. After treatment, the intervention group showed improved PA levels, perceived physical ability, and throwing and jumping task performances compared to the control group. Results indicate that a multicomponent program can improve levels of PA, fitness, and perceived competence of overweight participants. Findings highlight the importance of a comprehensive healthy lifestyle program that includes physical, psychosocial, and behavioral factors and suggest practical implications for educators, trainers, and teachers in identifying best practices targeting childhood obesity.",2020,"After treatment, the intervention group showed improved PA levels, perceived physical ability, and throwing and jumping task performances compared to the control group.","['school-aged children', 'Overweight and Obese Children', 'overweight/obese boys and girls aged 10-12 years']","['7-month after-school program in addition to curricular physical education lessons, while the nonclinical control group ( n  = 29) received usual curricular lessons', 'school-based multicomponent intervention']","['PA levels, perceived physical ability, and throwing and jumping task performances', 'physical activity (PA) levels, actual physical abilities, and perceived physical abilities', 'levels of PA, fitness, and perceived competence of overweight participants', 'Physical Activity and Physical Competence', ""levels of PA and fitness and individual's perceptions of physical ability""]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",35.0,0.0145829,"After treatment, the intervention group showed improved PA levels, perceived physical ability, and throwing and jumping task performances compared to the control group.","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Morano', 'Affiliation': 'Parisi-De Sanctis Institute, MIUR (Italian Ministry of Education, University and Research), 71121 Foggia, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Robazza', 'Affiliation': 'BIND-Behavioral Imaging and Neural Dynamics Center, Department of Medicine and Aging Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, 66013 Chieti, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bortoli', 'Affiliation': 'BIND-Behavioral Imaging and Neural Dynamics Center, Department of Medicine and Aging Sciences, ""G. d\'Annunzio"" University of Chieti-Pescara, 66013 Chieti, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Rutigliano', 'Affiliation': 'Pediatrics, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.'}, {'ForeName': 'Montse C', 'Initials': 'MC', 'LastName': 'Ruiz', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, 40014 Jyväskylä, Finland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Campanozzi', 'Affiliation': 'Pediatrics, Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176370']
3053,32885875,"Comparison of short-term light disturbance, optical and visual performance outcomes between a myopia control contact lens and a single-vision contact lens.","PURPOSE


To compare the optical and visual performance of a dual-focus (DF) contact lens used for myopia control with a single-vision (SV) contact lens of the same material.
METHODS


A randomised, double-masked crossover study. Twenty-eight healthy, myopic volunteers between 18 and 32 years of age (23.49 ± 4.07 years) participated in this study. The sensory dominant eye for distance vision was determined. Refraction, best-corrected visual acuity (VA) and aberrations for 3 mm and 5 mm pupil diameters were quantified without a contact lens in situ. Subjects were fitted with two contact lens designs: DF and SV, both made of omafilcon A material. The Quality of Vision (QoV) questionnaire, over-refraction, best-corrected VA, stereopsis at 40 cm, best-corrected photopic and mesopic contrast sensitivity, light disturbance and aberrations were assessed 25 min after contact lens insertion.
RESULTS


There were no statistically significant differences in best-corrected VA and stereopsis between the baseline, DF and SV conditions. Photopic and mesopic contrast sensitivity were lower for the DF contact lens at all frequencies, with the exception of the mesopic contrast sensitivity at 18 cycles per degree (p = 0.23). Higher order aberrations and light disturbance size and irregularity were higher for the DF contact lens (p < 0.001). No differences were found in higher order aberrations between baseline and the SV contact lens condition for each pupil diameter. QoV scores also revealed lower frequency, severity and bothersome scores with the SV contact lens than with the DF contact lens (p < 0.001).
CONCLUSIONS


The DF contact lens design decreased the psychophysical and psychometric visual quality scores in the short-term under dim-light conditions when compared with a single-vision contact lens design of the same material. VA and stereopsis were unaffected by the lens design.",2020,Higher order aberrations and light disturbance size and irregularity were higher for the DF contact lens (p < 0.001).,"['myopia control with a single-vision (SV) contact lens of the same material', 'Twenty-eight healthy, myopic volunteers between 18 and 32\xa0years of age (23.49\xa0±\xa04.07\xa0years) participated in this study']","['myopia control contact lens and a single-vision contact lens', 'dual-focus (DF) contact lens']","['frequency, severity and bothersome scores', 'Photopic and mesopic contrast sensitivity', 'Refraction, best-corrected visual acuity (VA) and aberrations for 3\xa0mm and 5\xa0mm pupil diameters', 'psychophysical and psychometric visual quality scores', 'Quality of Vision (QoV) questionnaire, over-refraction, best-corrected VA, stereopsis at 40\xa0cm, best-corrected photopic and mesopic contrast sensitivity, light disturbance and aberrations', 'Higher order aberrations and light disturbance size and irregularity', 'QoV scores']","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1688601', 'cui_str': 'Overrefraction'}, {'cui': 'C0011586', 'cui_str': 'Stereoscopic vision'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",28.0,0.0580162,Higher order aberrations and light disturbance size and irregularity were higher for the DF contact lens (p < 0.001).,"[{'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'García-Marqués', 'Affiliation': 'Optometry Research Group, Department of Optics and Optometry and Vision Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Rute Juliana', 'Initials': 'RJ', 'LastName': 'Macedo-De-Araújo', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab), Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Cerviño', 'Affiliation': 'Optometry Research Group, Department of Optics and Optometry and Vision Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'García-Lázaro', 'Affiliation': 'Optometry Research Group, Department of Optics and Optometry and Vision Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': 'McAlinden', 'Affiliation': 'Department of Ophthalmology, Singleton Hospital, Swansea Bay University Health Board, Swansea, UK.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'González-Méijome', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab), Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12729']
3054,32841892,Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide.,"This study used a novel theory-informed latent class approach, based on the Interpersonal Psychological Theory of Suicide (IPTS), to identify subgroups of individuals with a suicide attempt history. The identification of subgroups can inform treatments that target these specific subgroups. Using data from a randomised controlled trial, latent class analysis was conducted on 227 adults with a suicide attempt history. Latent classes were identified based on suicide attempt history, perceived burdensomeness, thwarted belongingness, and capability for suicide at the trial baseline. Three classes were found. Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants). Class 1 had elevated suicidal ideation for the duration of the trial. Classes 1 and 2 also had elevated interpersonal risks relative to a population-based sample. These results suggest that some individuals with a suicide attempt history exhibit relatively low interpersonal risks, and given concurrent protective psychological factors, may be suited to low-intensity interventions. At the other extreme, some individuals with a suicide attempt history require high-intensity interventions addressing interpersonal risks, clinical symptoms, and protective psychological factors.",2020,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","['individuals with a suicide attempt history', 'Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide', '227 adults with a suicide attempt history']",[],"['elevated suicidal ideation', 'interpersonal risks and clinical symptoms, and lower protective psychological factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033906', 'cui_str': 'Psychological Theories'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}]",227.0,0.0482775,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","[{'ForeName': 'Quincy J J', 'Initials': 'QJJ', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia; School of Psychology, Western Sydney University, Sydney, NSW, Australia. Electronic address: q.wong@westernsydney.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Bregje A J', 'Initials': 'BAJ', 'LastName': 'van Spijker', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}]",Psychiatry research,['10.1016/j.psychres.2020.113406']
3055,32853691,Development and validation of screening scores of non-alcoholic fatty liver disease in middle-aged and elderly Chinese.,"AIM


Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease and also closely related to cardiometabolic disease. Its prevalence was estimated at over one-fourth in the general population in China. We aimed to develop effective score tools for detecting NAFLD.
METHODS


A total of 17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis. All participants were randomly classified into the exploratory group or the validation group. Candidate categorical variables were selected using a logistic regression model. The score points were generated according to the β-coefficients.
RESULTS


We developed the Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I), which included body mass index and waist circumference with an area under the receiver-operating characteristic curve (AUC) of 0.802 (95% CI 0.792-0.811) in the exploratory group and 0.802 (95% CI 0.793-0.812) in the validation group. We further developed the SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC of 0.852 (95% CI 0.843-0.861) in the exploratory group and 0.843 (95% CI 0.834-0.852) in the validation group. The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
CONCLUSIONS


Based on anthropometric and clinical categorical variables, our two scores are effective tools for detecting NAFLD in both this southern Chinese population and their subpopulation with normal ALT levels.",2020,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","['subjects with normal alanine aminotransferase (ALT) levels', 'middle-aged and elderly Chinese', '17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis']",[],"['Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I', 'SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",17212.0,0.0822862,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: houxuhong@sjtu.edu.cn.""}, {'ForeName': 'Peizhu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Fusong', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Lichang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Prevention and Health Care, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108385']
3056,32856597,Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial.,"BACKGROUND


The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use.
OBJECTIVE


This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months.
METHODS


Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated.
RESULTS


Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring-measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001).
CONCLUSIONS


Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381.",2020,">250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively.","['people with type 2 diabetes (T2D', 'Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female', 'Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019', 'Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic']",['telemedicine consultation with a clinic endocrinologist'],"['systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides', 'change in HbA1c', 'weight and blood pressure', 'hypoglycemia', 'HbA1c, increased TIR, decreased time in hyperglycemia', 'Mean weight', 'Glycemic Outcomes', 'Continuous glucose monitoring-measured (n=43) percent time in range (TIR', 'blood pressure and serum lipids', 'change in weight and in RT-CGM glycemic metrics', 'HbA1c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologist'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",55.0,0.151487,">250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively.","[{'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Majithia', 'Affiliation': 'Department of Medicine and Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, United States.'}, {'ForeName': 'Coco M', 'Initials': 'CM', 'LastName': 'Kusiak', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Armento Lee', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'Francis R', 'Initials': 'FR', 'LastName': 'Colangelo', 'Affiliation': 'Allegheny Health Network, Monroeville, PA, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Romanelli', 'Affiliation': 'Sutter Health, Palo Alto, CA, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Robertson', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Erani', 'Affiliation': 'Onduo Professionals, PC, Newton, MA, United States.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Layne', 'Affiliation': 'Onduo, LLC, Newton, MA, United States.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'Dixon', 'Affiliation': 'Onduo, LLC, Newton, MA, United States.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Zisser', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}]",Journal of medical Internet research,['10.2196/21778']
3057,32859522,Identifying ActiGraph non-wear time in pregnant women with overweight or obesity.,"OBJECTIVES


Non-wear time algorithms have not been validated in pregnant women with overweight/obesity (PW-OW/OB), potentially leading to misclassification of sedentary/activity data, and inaccurate estimates of how physical activity is associated with pregnancy outcomes. We examined: (1) validity/reliability of non-wear time algorithms in PW-OW/OB by comparing wear time from five algorithms to a self-report criterion and (2) whether these algorithms over- or underestimated sedentary behaviors.
DESIGN


PW-OW/OB (N = 19) from the Healthy Mom Zone randomized controlled trial wore an ActiGraph GT3x + for 7 consecutive days between 8-12 weeks gestation.
METHODS


Non-wear algorithms (i.e., consecutive strings of zero acceleration in 60-second epochs) were tested at 60, 90, 120, 150, and 180-min. The monitor registered sedentary minutes as activity counts 0-99. Women completed daily self-report logs to report wear time.
RESULTS


Intraclass correlation coefficients for each algorithm were 0.96-0.97; Bland-Altman plots revealed no bias; mean absolute percent errors were <10%. Compared to self-report (M = 829.5, SD = 62.1), equivalency testing revealed algorithm wear times (min/day) were equivalent: 60- (M = 816.4, SD = 58.4), 90- (M = 827.5, SD = 61.4), 120- (M = 830.8, SD = 65.2), 150- (M = 833.8, SD = 64.6) and 180-min (M = 837.4, SD = 65.4). Repeated measures ANOVA showed 60- and 90-min algorithms may underestimate sedentary minutes compared to 150- and 180-min algorithms.
CONCLUSIONS


The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB. However, implementing algorithms with a higher threshold for consecutive zero counts (i.e., ≥150-min) can avoid the risk of misclassifying sedentary data.",2020,"The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB.","['pregnant women with overweight or obesity', 'pregnant women with overweight/obesity (PW-OW/OB']",['ActiGraph GT3x'],['daily self-report logs to report wear time'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0416337,"The 60, 90, 120, 150, and 180-min algorithms are valid and reliable for estimating wear time in PW-OW/OB.","[{'ForeName': 'Krista S', 'Initials': 'KS', 'LastName': 'Leonard', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Pauley', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Department of Nutritional Sciences and Center for Childhood Obesity Research, The Pennsylvania State University, United States.'}, {'ForeName': 'Penghong', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'School for Engineering of Matter, Transport, and Energy, Arizona State University, United States.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Rivera', 'Affiliation': 'School for Engineering of Matter, Transport, and Energy, Arizona State University, United States.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Department of Nutritional Sciences and Center for Childhood Obesity Research, The Pennsylvania State University, United States.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Symons Downs', 'Affiliation': 'Exercise Psychology Laboratory, Department of Kinesiology, The Pennsylvania State University, United States; Department of OBGYN, College of Medicine, The Pennsylvania State University, United States. Electronic address: dsd11@psu.edu.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.08.003']
3058,32861614,[Lessons learned: Challenges faced in the recruitment process for the cluster-randomized nursing home study HIOPP-3 iTBX].,"INTRODUCTION


The cluster-randomized multicenter HIOPP-3 iTBX study ('General Practitioners' Initiative to optimize Medication safety for Nursing Home Residents - using an interprofessional toolbox') aims to improve medication safety in nursing home residents through a complex interprofessional intervention focusing on neuroleptics and potentially inadequate medications. A stepwise recruitment process was used for all study participants (nursing homes, general practitioners, pharmacists, nursing home residents). The aim of this article is to describe the underlying recruitment strategy, the results of the recruitment and the measures undertaken to recruit the necessary number of participants.
METHODS


The recruitment strategy and the response rates of nursing homes, general practitioners, pharmacists and nursing home residents are described. Measures to improve recruitment at the study sites and reasons for refusal to participate were documented.
RESULTS


The response rate in nursing homes was 8.4 % (n=44). Of the pharmacists contacted by these nursing homes 70.3 % (n=52) participated, and 43.5 % (n=91) of all contacted general practitioners. Twenty-three (33.0 %) nursing homes had to be excluded from the study because no interprofessional team could be formed. Of all nursing home residents under the care of the participating general practitioners 862 (43,5%) persons and/or their caregivers gave consent to participate in the study. The recruitment for the study took 14 months. In the course of recruitment, recruitment strategies had to be adapted to local circumstances at the study sites. Reasons for non-participation varied between the different groups.
DISCUSSION AND CONCLUSION


The main challenge in the HIOPP-3 iTBX study was to form interprofessional teams in each cluster. A stepwise, partly dependent recruitment process in a large group of potential participants presents organizational challenges that should be taken into account while planning the study. In order to reach the calculated sample size in the HIOPP-3 iTBX study, a pragmatic and flexible approach, adapted to local circumstances, was required. Further studies may benefit from the experiences made in the HIOPP-3 iTBX study.",2020,"A stepwise recruitment process was used for all study participants (nursing homes, general practitioners, pharmacists, nursing home residents).","['nursing homes 70.3\xa0% (n=52) participated, and 43.5\xa0% (n=91) of all contacted general practitioners', 'nursing home residents', 'Twenty-three (33.0\xa0%) nursing homes had to be excluded from the study because no interprofessional team could be formed', 'nursing home residents under the care of the participating general practitioners 862 (43,5%) persons and/or their caregivers gave consent to participate in the study', 'Nursing Home Residents - using an interprofessional toolbox', 'participants (nursing homes, general practitioners, pharmacists, nursing home residents', 'nursing homes, general practitioners, pharmacists and nursing home residents']",['HIOPP-3'],['response rate'],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]",[],[],,0.0366357,"A stepwise recruitment process was used for all study participants (nursing homes, general practitioners, pharmacists, nursing home residents).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kirsch', 'Affiliation': 'Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland. Electronic address: kirsch.claudia@mh-hannover.de.'}, {'ForeName': 'Ina-Merle', 'Initials': 'IM', 'LastName': 'Doyle', 'Affiliation': 'Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Krause', 'Affiliation': 'Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Junius-Walker', 'Affiliation': 'Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland.'}, {'ForeName': 'Birgitt', 'Initials': 'B', 'LastName': 'Wiese', 'Affiliation': 'Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Thürmann', 'Affiliation': 'Institut für Pharmakologie - Philipp Klee-Institut, Universität Witten/Herdecke, Wuppertal, Deutschland.'}, {'ForeName': 'Lisa Christine', 'Initials': 'LC', 'LastName': 'Sparenberg', 'Affiliation': 'Institut für Allgemeinmedizin, Universitätsmedizin Rostock, Rostock, Deutschland.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Wollny', 'Affiliation': 'Institut für Allgemeinmedizin, Universitätsmedizin Rostock, Rostock, Deutschland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fuchs', 'Affiliation': 'Institut für Allgemeinmedizin, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Deutschland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilm', 'Affiliation': 'Institut für Allgemeinmedizin, Heinrich-Heine Universität Düsseldorf, Düsseldorf, Deutschland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Institut für Allgemeinmedizin und Interprofessionelle Versorgung, Universitätsklinikum und Medizinische Fakultät Tübingen, Tübingen, Deutschland.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Stolz', 'Affiliation': 'Institut für Allgemeinmedizin und Interprofessionelle Versorgung, Universitätsklinikum und Medizinische Fakultät Tübingen, Tübingen, Deutschland.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Haumann', 'Affiliation': 'Institut für Allgemeinmedizin und Interprofessionelle Versorgung, Universitätsklinikum und Medizinische Fakultät Tübingen, Tübingen, Deutschland.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2020.07.002']
3059,32862232,The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics.,"BACKGROUND


The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD; NCT03036150) trial was designed to assess the effect of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on kidney and cardiovascular events in participants with CKD with and without type 2 diabetes (T2D). This analysis reports the baseline characteristics of those recruited, comparing them with those enrolled in other trials.
METHODS


In DAPA-CKD, 4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 were randomized to dapagliflozin 10 mg once daily or placebo. Mean eGFR was 43.1 mL/min/1.73 m2 and median UACR was 949 mg/g (108 mg/mmol).
RESULTS


Overall, 2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes. The most common causes of CKD after diabetes (n = 2510) were ischaemic/hypertensive nephropathy (n = 687) and chronic glomerulonephritis (n = 695), of which immunoglobulin A nephropathy (n = 270) was the most common. A total of 4174 participants (97%) were receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8%) glucagon-like peptide 1 receptor agonists. In contrast to the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes. The mean eGFR of participants in the DAPA-CKD trial was 13.1 mL/min/1.73 m2 lower than in CREDENCE, similar to that in the Finerenone in Reducing Kidney Failure and Disease Progression in DKD (FIDELIO-DKD) trial and the Study Of diabetic Nephropathy with AtRasentan (SONAR).
CONCLUSIONS


Participants with a wide range of underlying kidney diseases receiving renin-angiotensin system blocking therapy have been enrolled in the DAPA-CKD trial. The trial will examine the efficacy and safety of dapagliflozin in participants with CKD Stages 2-4 and increased albuminuria, with and without T2D.",2020,Mean eGFR was 43.1 mL/min/1.73 ,"['participants with CKD with and without type 2 diabetes (T2D', 'CKD after diabetes (n\u2009=\u20092510) were ischaemic/hypertensive nephropathy (n\u2009=\u2009687) and chronic glomerulonephritis (n\u2009=\u2009695), of which immunoglobulin', '4174 participants (97%) were receiving an', ' 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8', 'Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes', 'participants with CKD Stages 2-4 and increased albuminuria, with and without T2D', 'Participants with a wide range of underlying kidney diseases receiving', 'chronic kidney disease (DAPA-CKD', '2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes', '4304 participants with a urinary albumin:creatinine ratio (UACR) ≥200']","['dapagliflozin 10\u2009mg once daily or placebo', 'renin-angiotensin system blocking therapy', 'glucagon-like peptide 1 receptor agonists', 'angiotensin-converting enzyme inhibitor or angiotensin receptor blocker', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin', 'dapagliflozin']","['Kidney Failure and Disease Progression', 'efficacy and safety', 'glomerular filtration rate (eGFR', 'kidney and cardiovascular events', 'Mean eGFR', 'm2 and median UACR', 'mean eGFR']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0848548', 'cui_str': 'Hypertensive renal disease'}, {'cui': 'C0152451', 'cui_str': 'Chronic glomerulonephritis'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C2316786', 'cui_str': 'Chronic kidney disease stage 2'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",4304.0,0.0859358,Mean eGFR was 43.1 mL/min/1.73 ,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Batiushin', 'Affiliation': 'Department of Nephrology, Rostov State Medical University, Rostov, Russia.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Bilchenko', 'Affiliation': 'Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine.'}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Douthat', 'Affiliation': 'Department of Nephrology, Hospital Privado Universitario de Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Dwyer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Escudero', 'Affiliation': 'Division of Nephrology, Hospital Arzobispo Loayza, Cayetano Heredia University, Lima, Peru.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontificia Universidade Catolica do Parana, Curitiba, Brazil.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Furuland', 'Affiliation': 'Department of Medical Sciences Renal Unit, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Górriz', 'Affiliation': 'Department of Nephrology, University Clinic Hospital, INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Haller', 'Affiliation': 'Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, Division of Nephrology, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China.'}, {'ForeName': 'Shin-Wook', 'Initials': 'SW', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Rey', 'Initials': 'R', 'LastName': 'Isidto', 'Affiliation': 'Healthlink Medical, Dental, Surgical Clinics and Diagnostics Center, Iloilo City, Philippines.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khullar', 'Affiliation': 'Department of Nephrology and Renal Transplant Medicine, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kashihara', 'Affiliation': 'Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Nowicki', 'Affiliation': 'Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kausik', 'Initials': 'K', 'LastName': 'Umanath', 'Affiliation': 'Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Pham', 'Initials': 'P', 'LastName': 'Van Bui', 'Affiliation': 'Pham Ngoc Thach Medicine University, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Wittmann', 'Affiliation': 'Second Department of Medicine and Nephrology-Diabetes Center, University of Pécs Medical School, Pécs, Hungary.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa234']
3060,32863098,Examining persuasive message type to encourage staying at home during the COVID-19 pandemic and social lockdown: A randomized controlled study in Japan.,"OBJECTIVE


Behavioral change is the only prevention against the COVID-19 pandemic until vaccines become available. This is the first study to examine the most persuasive message type in terms of narrator difference in encouraging people to stay at home during the COVID-19 pandemic and social lockdown.
METHODS


Participants (n = 1,980) were randomly assigned to five intervention messages (from a governor, a public health expert, a physician, a patient, and a resident of an outbreak area) and a control message. Intention to stay at home before and after reading messages was assessed. A one-way ANOVA with Tukey's or Games-Howell test was conducted.
RESULTS


Compared with other messages, the message from a physician significantly increased participants' intention to stay at home in areas with high numbers of people infected (versus a governor, p = .002; an expert, p = .023; a resident, p = .004).
CONCLUSION


The message from a physician-which conveyed the crisis of overwhelmed hospitals and consequent risk of people being unable to receive treatment-increased the intent to stay at home the most.
PRACTICE IMPLICATIONS


Health professionals and media operatives may be able to encourage people to stay at home by disseminating the physicians' messages through media and the internet.",2020,"Compared with other messages, the message from a physician significantly increased participants' intention to stay at home in areas with high numbers of people infected (versus a governor, p = .002; an expert, p = .023; a resident, p = .004).
","['Participants (n\u2009=\u20091,980', 'Japan']","['five intervention messages (from a governor, a public health expert, a physician, a patient, and a resident of an outbreak area) and a control message']",[],"[{'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0347361,"Compared with other messages, the message from a physician significantly increased participants' intention to stay at home in areas with high numbers of people infected (versus a governor, p = .002; an expert, p = .023; a resident, p = .004).
","[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okuhara', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan. Electronic address: okuhara-ctr@umin.ac.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.016']
3061,32864760,A comparative study of topical 5% cysteamine versus 4% hydroquinone in the treatment of facial melasma in women.,"OBJECTIVE


To assess the efficacy and safety of topical 5% cysteamine versus 4% hydroquinone in the treatment of facial melasma in women. Topical 5% cysteamine is an antioxidant and tyrosinase inhibitor that has been shown to be effective in the treatment of melasma. However, to date, no study has compared the performance of topical cysteamine to hydroquinone for facial melasma.
METHODS


A quasi-randomized, multicenter, evaluator-blinded clinical trial was conducted on 40 women with facial melasma who were submitted to the nightly application of 5% cysteamine (CYS) or 4% hydroquinone (HQ) on hyperpigmented areas for 120 days. Both groups were required to use tinted sunscreen (SPF 50; PPD 19). Subjects were assessed at the inclusion and after 60 and 120 days of treatment for mMASI, MELASQoL, and the difference in colorimetric luminosity between melasma and the adjacent unaffected skin. The Global Aesthetic Improvement Scale was used to assess the difference in the appearance of the skin through standardized photographs.
RESULTS


The mean reduction of the mMASI scores was 24% for CYS and 41% for HQ (P = 0.015) at 60 days, and 38% for CYS and 53% for HQ (P = 0.017) at 120 days. The photographic evaluation revealed up to 74% improvement for both groups, without statistically significant difference between them (P = 0.087). The MELASQoL score showed a progressive decrease for both groups over time, despite the greater reduction for HQ after 120 days (P = 0.018). Colorimetric assessment disclosed progressive depigmenting in both groups, without statistically significant difference between them (P > 0.160). No severe adverse effects were identified in either group. Erythema and burning were the most important local adverse effects with cysteamine, although their frequency did not differ between groups (P > 0.170).
CONCLUSION


Cysteamine proved to be safe, well-tolerated, and effective, despite its inferior performance to hydroquinone in decreasing mMASI and MELASQoL in the treatment of melasma.",2020,"The mean reduction of the mMASI scores was 24% for CYS and 41% for HQ (P = 0.015) at 60 days, and 38% for CYS and 53% for HQ (P = ","['40 women with facial melasma who were submitted to the nightly application of 5', 'facial melasma in women']","['hydroquinone', 'topical 5% cysteamine versus 4% hydroquinone', 'cysteamine (CYS) or 4% hydroquinone (HQ']","['severe adverse effects', 'HQ', 'efficacy and safety', 'Erythema and burning', 'Colorimetric assessment disclosed progressive depigmenting', 'Global Aesthetic Improvement Scale', 'mean reduction of the mMASI scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0020306', 'cui_str': 'hydroquinone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0574208,"The mean reduction of the mMASI scores was 24% for CYS and 41% for HQ (P = 0.015) at 60 days, and 38% for CYS and 53% for HQ (P = ","[{'ForeName': 'Paula Basso', 'Initials': 'PB', 'LastName': 'Lima', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, Brazil.'}, {'ForeName': 'Joana Alexandria Ferreira', 'Initials': 'JAF', 'LastName': 'Dias', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cassiano', 'Affiliation': 'Departamento de Dermatologia, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Ana Cláudia Cavalcante', 'Initials': 'ACC', 'LastName': 'Esposito', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, Brazil.'}, {'ForeName': 'Ediléia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Departamento de Dermatologia, UNIFESP, São Paulo, Brazil.'}, {'ForeName': 'Luciane Donida Bartoli', 'Initials': 'LDB', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, Brazil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, Brazil.'}]",International journal of dermatology,['10.1111/ijd.15146']
3062,32868028,Effect of Whole-Body Vibration Exercise on Power Profile and Bone Mineral Density in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.,"OBJECTIVE


The purpose of this study was to investigate the effect of whole-body vibration (WBV) on muscle work and bone mineral density (BMD) of the lumbar vertebrae and femur in postmenopausal women.
METHODS


Forty-three postmenopausal women with low BMD were randomly assigned to WBV and control groups. Both groups received calcium and vitamin D supplementations once daily, while the WBV group additionally received WBV exercise (twice/wk) for 24 successive weeks. Qualisys gait analysis system was used to measure hip power generation by hip extensors (H1S) and flexors (H3S), hip power absorption by hip flexors (H2S), knee power absorption by quadriceps during loading response (K1S) and preswing (K3S), knee power absorption by hamstring (K4S), knee power generation by quadriceps (K2S), ankle power absorption by dorsiflexors (A1S) and plantar flexors (A2S), and ankle power generation by plantar flexors (A3S). Also, dual-energy X-ray absorptiometry was used to measure BMD of the lumbar vertebrae and femur before and after the intervention.
RESULTS


There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group. However, there were no significant changes (P > .05) in the control group. The posttreatment values of the hip, knee, and ankle muscle work and BMD of the WBV group were significantly (P < .05) higher than the posttreatment values of the control group.
CONCLUSION


Whole-body vibration training improved the leg muscle work and lumbar and femoral BMD in postmenopausal women with low BMD.",2020,"There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group.","['postmenopausal women with low BMD', 'Forty-three postmenopausal women with low BMD', 'Postmenopausal Women With Osteoporosis', 'postmenopausal women']","['Whole-Body Vibration Exercise', 'Whole-body vibration training', 'calcium and vitamin D supplementations', 'whole-body vibration (WBV', 'WBV exercise']","['hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur', 'leg muscle work and lumbar and femoral BMD', 'posttreatment values of the hip, knee, and ankle muscle work and BMD', 'muscle work and bone mineral density (BMD', 'Power Profile and Bone Mineral Density', 'hip power generation by hip extensors (H1S) and flexors (H3S), hip power absorption by hip flexors (H2S), knee power absorption by quadriceps during loading response (K1S) and preswing (K3S), knee power absorption by hamstring (K4S), knee power generation by quadriceps (K2S), ankle power absorption by dorsiflexors (A1S) and plantar flexors (A2S), and ankle power generation by plantar flexors (A3S']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C2001403', 'cui_str': 'H2S(D2S)'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]",43.0,0.0192285,"There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group.","[{'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'ElDeeb', 'Affiliation': ""Department of Physical Therapy for Women's Health, Cairo University, Giza, Egypt.""}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Abdel-Aziem', 'Affiliation': 'Department of Biomechanics, Cairo University, Giza, Egypt. Electronic address: Amralmaz@yahoo.com.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.12.003']
3063,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
3064,32874107,Can A Superimposed Whole-Body Electromyostimulation Intervention Enhance the Effects of a 10-Week Athletic Strength Training in Youth Elite Soccer Players?,"Strength training in youth soccer has both a preventive and a sports-specific component. Whole-body electromyostimulation (WB-EMS) could represent an interesting time-saving add-on to classical strength exercises in performance-oriented soccer. The objective of this study was to find out whether a 10-week superimposed WB-EMS training might have a more positive impact on strength parameters in male youth elite soccer players than regular athletic strength exercises alone. A total of 30 male youth soccer players from a youth academy aged 15 to 17 years participated in the study. Before and after the intervention, the isometric extension and flexion forces of trunk and knee, and the hip abduction and adduction forces were tested. Twelve players (control group) absolved a conventional 20-minute strength training once a week for a period of ten weeks. Eighteen players absolved the same exercises but with superimposed WB-EMS. Blood creatine kinase concentration was measured for training control. ANOVAs, Friedman tests and post hoc t-tests were calculated (p = 0.05) to examine the strength development during the training period between the groups. While we could not find significant strength increases in the leg, hip and trunk muscles in the control group (<4%), the strength of the WB-EMS group improved significantly in 4 of the 6 muscle groups tested. In this group, the strength of knee flexors increased significantly by 20.68 ± 21.55%, knee extensors by 31.43 ± 37.02%, hip adductors by 21.70 ± 12.86% and trunk flexors by 33.72 ± 27.43%. The rates of strength increase are partly in line with other studies, partly clearly higher, which might be explained by the athletically active target group. A 10-week superimposed WB-EMS training improves the strength of certain leg, hip and trunk muscles in male adolescent elite soccer players to a greater extent than a pure athletic strength training of the same duration.",2020,"While we could not find significant strength increases in the leg, hip and trunk muscles in the control group (<4%), the strength of the WB-EMS group improved significantly in 4 of the 6 muscle groups tested.","['30 male youth soccer players from a youth academy aged 15 to 17 years participated in the study', 'male adolescent elite soccer players', 'Youth Elite Soccer Players', 'male youth elite soccer players', 'Twelve players (control group) absolved a', 'youth soccer']","['Strength training', 'Whole-body electromyostimulation (WB-EMS', '10-Week Athletic Strength Training', 'superimposed WB-EMS training', 'conventional 20-minute strength training', 'regular athletic strength exercises alone']","['strength of certain leg, hip and trunk muscles', 'Blood creatine kinase concentration', 'leg, hip and trunk muscles', 'strength of knee flexors', 'rates of strength increase', 'isometric extension and flexion forces of trunk and knee, and the hip abduction and adduction forces']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0853178', 'cui_str': 'Blood creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",30.0,0.0122547,"While we could not find significant strength increases in the leg, hip and trunk muscles in the control group (<4%), the strength of the WB-EMS group improved significantly in 4 of the 6 muscle groups tested.","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ludwig', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Schuh', 'Affiliation': 'Nachwuchsleistungszentrum Saar (Youth Academy) SV 07 Elversberg, Elversberg, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Backfisch', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, Technische Universität Kaiserslautern, Kaiserslautern, Germany.'}]",Journal of sports science & medicine,[]
3065,32874108,Effects of 8-Week Jump Training Program on Sprint and Jump Performance and Leg Strength in Pre- and Post-Peak Height Velocity Aged Boys.,"The purpose of this study was: (a) to determine the effects of an 8-week jump training program on measures of neuromuscular performance in 12-14-year-old boys before and after peak height velocity (PHV), and (b) to compare the effects of the jump training program to the effects of the regular physical education program. One hundred and twenty-six participants were categorized into two maturity groups (pre- or post-PHV) and then randomly assigned to either a jump training (pre-PHV, n = 26; post-PHV, n = 24) or a control (pre-PHV, n = 33; post-PHV, n = 19) group. Jump training consisted of twice-weekly training for 8 weeks, while control groups continued with their regular physical education lessons. Squat jump and countermovement jump height (cm), reactive strength index (the ratio between jump height and ground contact time (mm/ms)), 20-m sprint time (s), and isokinetic knee extensors muscle strength (peak toque (Nm)) were assessed pre- and post-intervention. Following the 8-week intervention, both pre- and post-PHV jump training groups made significant gains in measures of neuromuscular performance irrespective of the maturity (where p < 0.05,  d  = 0.28-1.00), while changes in these measures in the control groups were not significant (all p ≥ 0.05,  d  = -0.14-0.15). A series of repeated measures analyses of variance (ANOVA) indicated that (a) the maturity-related differences between jump training groups were observed only for reactive strength index, and (b) the improvements in all measures of neuromuscular performance were greater in jump training than in control group. This study demonstrated that important components of physical fitness in 12-14-year-old schoolboys may be acutely enhanced through a well-structured jump program and maturity seems to at least play a limited role in mediating these enhancements.",2020,"Following the 8-week intervention, both pre- and post-PHV jump training groups made significant gains in measures of neuromuscular performance irrespective of the maturity (where p < 0.05,  d  = 0.28-1.00), while changes in these measures in the control groups were not significant (all p ≥ 0.05,  d  = -0.14-0.15).","['One hundred and twenty-six participants', '12-14-year-old boys before and after peak height velocity (PHV), and (b', 'Pre- and Post-Peak Height Velocity Aged Boys']","['8-Week Jump Training Program', 'jump training program', '8-week jump training program', 'jump training']","['neuromuscular performance irrespective of the maturity', 'neuromuscular performance', 'Sprint and Jump Performance and Leg Strength', 'Squat jump and countermovement jump height (cm), reactive strength index (the ratio between jump height and ground contact time (mm/ms)), 20-m sprint time (s), and isokinetic knee extensors muscle strength (peak toque (Nm']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",126.0,0.0109194,"Following the 8-week intervention, both pre- and post-PHV jump training groups made significant gains in measures of neuromuscular performance irrespective of the maturity (where p < 0.05,  d  = 0.28-1.00), while changes in these measures in the control groups were not significant (all p ≥ 0.05,  d  = -0.14-0.15).","[{'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Uzelac-Sciran', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Nejc', 'Initials': 'N', 'LastName': 'Sarabon', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Koper, Slovenia.'}, {'ForeName': 'Pavle', 'Initials': 'P', 'LastName': 'Mikulic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}]",Journal of sports science & medicine,[]
3066,32874115,Comfort and Ground Reaction Forces in Flat-Footed Female Runners: Comparison of Low-Dye Taping versus Sham Taping.,"The purpose of this study was to examine the effects of low-Dye tape on comfort and ground reaction forces (GRF) in flat-footed female runners. A randomized cross-over study was conducted on 15 flat-footed female recreational runners. Participants ran at three speeds (9, 10, 11 km/h) under two conditions: low-Dye and sham taping. Comfort level was assessed using a 150-mm visual analog scale. GRF data were collected using an instrumented treadmill. Stance time, peak forces, and loading rates were extracted. Low-Dye taping showed a lower comfort level (low-Dye, 63.8 (24.3) mm, sham 122.0 (16.0) mm, mean difference [95% confident intervals], -58.2 [68.2, 48.2] mm, p < 0.001). For all biomechanical variables, there was no interaction (taping condition a speed) effect or difference between taping conditions. As running speed increased, there was a decrease in stance time (p < 0.001) and increase in loading rate (p = 0.009), impact peak (p = 0.004), active peak (p < .001), breaking peak (p < 0.001), propulsive peak (p < 0.001), medial peak (p < 0.001), and lateral peak (p < 0.001). Compared with sham taping, application of low-Dye taping was less comfortable but did not alter running ground reaction forces among flat-footed female runners.",2020,"For all biomechanical variables, there was no interaction (taping condition a speed) effect or difference between taping conditions.","['Participants ran at three speeds (9, 10, 11 km/h) under two conditions', 'Flat-Footed Female Runners', 'flat-footed female runners', '15 flat-footed female recreational runners']","['Low-Dye Taping versus Sham Taping', 'low-Dye and sham taping', 'low-Dye tape', 'Low-Dye taping', 'sham taping, application of low-Dye taping']","['active peak', 'Comfort level', 'breaking peak', 'stance time', 'propulsive peak', 'Comfort and Ground Reaction Forces', 'comfort level', 'Stance time, peak forces, and loading rates', 'loading rate', 'medial peak', 'running ground reaction forces', 'lateral peak', 'comfort and ground reaction forces (GRF']","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439494', 'cui_str': 'km/h'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0264133', 'cui_str': 'Acquired pes planus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}]",,0.332274,"For all biomechanical variables, there was no interaction (taping condition a speed) effect or difference between taping conditions.","[{'ForeName': 'Hui Li Alvina', 'Initials': 'HLA', 'LastName': 'Koh', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore.'}, {'ForeName': 'Wei-Hsiu', 'Initials': 'WH', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Education, Health and Recreation, National Chiayi University, Chiayi, Taiwan.'}, {'ForeName': 'Pui Wah', 'Initials': 'PW', 'LastName': 'Kong', 'Affiliation': 'Physical Education and Sports Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore.'}]",Journal of sports science & medicine,[]
3067,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
3068,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES


The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS


From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfilment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS


The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS


The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center, Japan; Division of Hematology, Department of Medicine, Jichi Medical University, Japan. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital, Japan.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University, Japan.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
3069,32890808,Which one is favorable in the elderly? Transoral rigid laryngoscopy or transnasal flexible fiberoptic laryngoscopy.,"PURPOSE


To determine whether transoral rigid laryngeal endoscopy (TORLE) or transnasal flexible fiberoptic laryngoscopy (TNFFL) is more favorable for laryngeal endoscopic examination in the elderly population.
METHODS


This randomized prospective study carried out in a tertiary reference center. TORLE or TNFFL were performed to patients who were over 65 years at their first visit according to randomization list. At their second visit, other method was performed. Patients' physiological parameters (Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen (O 2 ) saturation before and immediately after laryngeal examination were recorded. Patients' pain-irritation, gag reflex, and dyspnea status were evaluated using visual analog scale after first and second endoscopic examinations. Further patient preferences for TORLE and TNFFL were recorded.
RESULTS


Of 96 patients included in the study, 69.8% (n = 67) preferred TORLE while 30.2% (n = 29) preferred TNFFL. Major factor influencing patient preferences was pain-irritation in TNFFL. Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001). However, no significant difference was found between two methods with respect to gag reflex and dyspnea scores (p = 0.194, p = 0.327, respectively). In TORLE, there was no statistically significant difference between the values measured before and after examination in terms of SBP, DBP, HR, and O 2  saturation (p = 0.641, p = 0.134, p = 0.119, p = 0.414, respectively). However, in TNFFL, statistically significant decrease was observed after examination in HR and O 2  saturation (p < 0.001, p < 0.001, respectively).
CONCLUSION


TORLE is more suitable for laryngeal examination in elderly patients since it is more comfortable for patient and does not change physiological parameters.",2020,Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001).,"['96 patients included in the study, 69.8% (n', 'elderly patients']","['TNFFL', 'transoral rigid laryngeal endoscopy (TORLE) or transnasal flexible fiberoptic laryngoscopy (TNFFL', 'TORLE or TNFFL', 'Transoral rigid laryngoscopy or transnasal flexible fiberoptic laryngoscopy', 'TORLE']","['visual analog scale', 'pain-irritation, gag reflex, and dyspnea status', 'Pain-irritation scores', 'gag reflex and dyspnea scores', 'examination in HR and O 2  saturation', 'SBP, DBP, HR, and O 2  saturation', 'physiological parameters (Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen (O 2 ) saturation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0702149', 'cui_str': 'Flexible fiberoptic laryngoscopy'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",96.0,0.0255202,Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001).,"[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey. Electronic address: ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102660']
3070,32890862,Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders.,"The implementation of evidence-based psychological treatments (EBPTs) may be particularly challenging to accomplish in community mental health settings for individuals with severe mental illness (SMI). Transdiagnostic treatments, or treatments that target a mechanism that underpins multiple mental health problems, may be particularly well-suited to community mental health settings. This study examines community stakeholder perspectives (N = 22) of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) implemented in a community mental health setting in the context of a randomized controlled trial of TranS-C for SMI. The present study aimed to identify barriers and facilitators to the implementation of TranS-C for SMI in a community mental health setting using (1) a deductive theory-based process based on the Framework for Dissemination in Health Services Intervention Research and (2) an inductive thematic analysis process. All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting. Seven additional themes were identified through the inductive thematic analysis. A discussion of how the findings are related to prior research, other EBPT implementation, and future TranS-C implementation are included.",2020,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,['individuals with severe mental illness (SMI'],"['Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'transdiagnostic sleep and circadian intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0372757,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States; Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States. Electronic address: aharvey@berkeley.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.113443']
3071,32895874,Efficacy of oral rosuvastatin intervention on HDL and its associated proteins in men with type 2 diabetes mellitus.,"PURPOSE


High-density lipoprotein (HDL) undergoes structural and functional modification in patients with type 2 diabetes mellitus (T2DM). There are limited data on effect of rosuvastatin on HDL-associated proteins and the antiatherogenic effects of rosuvastatin. The present study intended to study the efficacy of rosuvastatin intervention on HDL-associated proteins and its other antiatherogenic effects in men with T2DM.
METHODS


Men with T2DM on oral antidiabetic treatment, with LDL-C levels > 75 mg/dL and willing for rosuvastatin intervention (20 mg/day orally for a period of 12 weeks), were included. Fasting glucose, lipid profile were measured using standard methods. Oxidized low-density lipoprotein (oxLDL), oxidized HDL (oxHDL), paraoxonase-1 (PON-1), tumour necrosis factor-α (TNF-α) and lecithin:cholesterol acyltransferase (LCAT) in serum were measured by ELISA; serum myeloperoxidase (MPO) by spectrophotometric method and cholesterol efflux by fluorometric assay. Carotid intima-media thickness (cIMT) measurement to assess vascular health status was done using doppler.
RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up. A decrease in MPO activity was found to be independently associated with an increase in cholesterol efflux.
CONCLUSIONS


Post intervention there is a quantitative and qualitative improvement in HDL, which helps in its reverse cholesterol transport (RCT) and antioxidant functions. Improvement in HDL functions and suppression of inflammation by rosuvastatin lead to regression in cIMT, which is beneficial in decreasing the progression of cardiovascular disease (CVD) in men with diabetes.",2020,"RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up.","['men with diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'men with type 2 diabetes mellitus', 'Men with T2DM on oral antidiabetic treatment, with LDL-C levels\u2009', 'men with T2DM']","['Carotid intima-media thickness (cIMT) measurement', 'Rosuvastatin', 'rosuvastatin', 'rosuvastatin intervention', 'oral rosuvastatin intervention']","['antiatherogenic HDL and cholesterol efflux', 'MPO activity', 'Fasting glucose, lipid profile', 'cholesterol efflux', 'Oxidized low-density lipoprotein (oxLDL), oxidized HDL (oxHDL), paraoxonase-1', 'PON-1), tumour necrosis factor-α (TNF-α) and lecithin:cholesterol acyltransferase (LCAT) in serum', 'lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0031617', 'cui_str': 'Lecithin'}, {'cui': 'C0008380', 'cui_str': 'Cholesterol acyltransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0204753,"RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up.","[{'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Naresh', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Bitla', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India. aparnabitla@yahoo.co.in.'}, {'ForeName': 'P V L N Srinivasa', 'Initials': 'PVLNS', 'LastName': 'Rao', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Sachan', 'Affiliation': 'Department of Endocrinology and Metabolism, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Yadagiri Lakshmi', 'Initials': 'YL', 'LastName': 'Amancharla', 'Affiliation': 'Department of Radiology, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}]",Endocrine,['10.1007/s12020-020-02472-5']
3072,32897117,Re: Effect of Intensive vs Standard Blood Pressure Treatment upon Erectile Function in Hypertensive Men: Findings from the Systolic Blood Pressure Intervention Trial.,,2020,,['Hypertensive Men'],['Intensive vs Standard Blood Pressure Treatment'],[],"[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0373286,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001252.03']
3073,32897125,Re: Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,,2020,,[],['Resident Physician Schedule without 24-Hour Shifts'],[],[],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",[],,0.0332029,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001256.01']
3074,32897150,Re: Randomized Study of Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-Year Postbiopsy Follow-Up.,,2020,,['Men on Active Surveillance (ASIST'],['Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.0661264,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001261.02']
3075,32897519,"Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled Trial.","INTRODUCTION


Antibiotic treatment can alter the gut microbiome and cause short-term gastrointestinal adverse effects (AEs). This study assessed the efficacy of lyophilized capsules containing 2 × 10 9  spores of Bacillus clausii (Enterogermina ® ; Sanofi Synthelabo) in reducing AEs associated with Helicobacter pylori eradication therapy in Italy.
METHODS


In this randomized, double-blind, single-center, phase IIIB study, 130 adult outpatients with H. pylori infection were assigned to receive one Enterogermina ®  capsule or placebo three times daily for 2 weeks (1:1). During week 1, all patients received clarithromycin 500 mg, amoxicillin 1 g, and rabeprazole 20 mg twice daily. The primary efficacy outcome was the presence of diarrhea in week 1.
RESULTS


A total of 130 patients were randomized. The incidence of diarrhea in week 1 was 29% in the B. clausii group and 48% in the placebo group [relative risk (RR) 0.61; 95% confidence interval (CI) 0.39-0.97; p = 0.03]. The incidence of diarrhea remained lower with B. clausii than with placebo in week 2 (RR 0.38; 95% CI 0.14-1.02; p = 0.0422). In week 1, the number of days without diarrhea was significantly higher in the B. clausii group than in the placebo group (6.25 vs. 5.86; p = 0.0304). In both groups, the number of days without diarrhea increased significantly (p < 0.0001) from week 1 to week 2. A total of three AEs occurred in two patients in the placebo group, but none were serious.
CONCLUSIONS


Compared with placebo, Enterogermina ®  reduced the incidence of, and the number of days with, diarrhea in patients receiving H. pylori eradication therapy. Enterogermina® was well tolerated.",2020,"In both groups, the number of days without diarrhea increased significantly (p < 0.0001) from week 1 to week 2.","['130 patients were randomized', '130 adult outpatients with H. pylori infection']","['placebo', 'Bacillus clausii Capsules', 'clarithromycin 500\xa0mg, amoxicillin 1\xa0g, and rabeprazole', 'Enterogermina ®  capsule or placebo', 'placebo, Enterogermina ®']","['incidence of diarrhea', 'Adverse Effects', 'number of days without diarrhea', 'number of days with, diarrhea', 'tolerated', 'presence of diarrhea']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",130.0,0.678921,"In both groups, the number of days without diarrhea increased significantly (p < 0.0001) from week 1 to week 2.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Plomer', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Iii Perez', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.'}, {'ForeName': 'Dorothea Maren', 'Initials': 'DM', 'LastName': 'Greifenberg', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany. Dorothea.Greifenberg@sanofi.com.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00333-2']
3076,32899902,Effect of Passive Stretching of Respiratory Muscles on Chest Expansion and 6-Minute Walk Distance in COPD Patients.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Hyperinflation of the lungs leads to a remodeling of the inspiratory muscles that causes postural deformities and more labored breathing. Postural changes include elevated, protracted, or abducted scapulae with medially rotated humerus, and kyphosis that leads to further tightening of respiratory muscles. As the severity of the disease progresses, use of the upper limbs for functional tasks becomes difficult due to muscle stiffness. There are various studies that suggest different rehabilitation programs for COPD patients; however, to the best of our knowledge none recommends passive stretching techniques. The aim of this study was to assess the effect of respiratory muscle passive stretching on chest expansion and 6-min walk distance (6MWD) in patients with moderate to severe COPD.
METHODS


Thirty patients were divided into two groups, experimental ( n  = 15) and control ( n  = 15). The experimental group received a hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints. The control group received a hot pack followed by relaxed passive movements of the shoulder joints.
RESULTS


In the control group, there was no difference in chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD between baseline and post treatment ( p  > 0.05). In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05). A comparison between control and experimental groups showed that chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.01) were significantly higher in the experimental group, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).
CONCLUSIONS


Although COPD is an irreversible disease, results of this study indicate that passive stretching of respiratory muscles can clinically improve the condition of such patients, especially in terms of chest expansion and 6MWD. Given the good effects of muscle stretching and the fact that such an exercise is harmless, clinicians and physiotherapists should consider including passive stretching of respiratory muscles in the rehabilitation plan of COPD patients.",2020,"In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).","['COPD patients', 'Chronic obstructive pulmonary disease (COPD', 'patients with moderate to severe COPD', 'COPD Patients', 'Thirty patients']","['Passive Stretching of Respiratory Muscles', 'hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints', 'respiratory muscle passive stretching', 'hot pack followed by relaxed passive movements of the shoulder joints']","['chest expansion', 'chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD', 'chest expansion and 6-min walk distance (6MWD', 'Chest Expansion and 6-Minute Walk Distance', '6MWD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]","[{'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0043356', 'cui_str': 'Structure of xiphoid process of sternum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",30.0,0.0204537,"In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).","[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Al Hosn One Day Surgery Center LLC, Al Sahel Tower Building, Post Box 37384, Abu Dhabi, UAE.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Ganai', 'Affiliation': 'Department of Rehabilitation Sciences, Jamia Hamdard, New Delhi 110062, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': 'Neuro-Physiotherapy Unit, NSC, All India Institute of Medical Sciences, New Delhi 110029, India.'}, {'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Zaheen A', 'Initials': 'ZA', 'LastName': 'Iqbal', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186480']
3077,32900672,[Communicating test results in a comprehensible manner: A randomized controlled trial of word usage in doctor-patient communication].,"INTRODUCTION


Doctor-patient communication is one of the hallmarks of good medical treatment. Mutual understanding is of foremost importance, in particular when communicating non-numerical test results.
METHODS


Using a two-step approach, this study analyses the influence of wording on the correct understanding of medical test results by people without a medical background. In a first step, a qualitative analysis of physicians' letters helped to identify adjectives that are frequently used to communicate test results. In a second step, a parallel randomised study was conducted to test the comprehensibility of particularly relevant adjectives, combining the written communication of test results with a subsequent survey. 1,131 participants, representing the population of Germany with regard to age, gender, and educational level, were recruited via an online platform. The participants read a scenario involving the communication of the results of a breath test, whereby non-numerical test results were described as being either ""positive"" vs. ""negative"" (n=566) or ""abnormal"" vs. ""normal"" (n=565). Participant assignment to one of these groups took place in a randomised way. The outcomes measured included the subjective and objective understanding of test results as well as the participants' subjective comprehension of the physician communicating with them.
RESULTS


People without a medical background can understand medical test results more readily when neutral, descriptive adjectives are used rather than adjectives considered as being judgmental in everyday language. 54 % of the participants who read test results using the adjectives ""positive"" vs. ""negative"" and 65 % of the participants who read test results using the adjectives ""abnormal"" vs. ""normal"", respectively, understood the results correctly. This relative difference of 20.4 % in the number of participants with a correct understanding is statistically significant (Chi square=13.061; p=0.001). There was also a considerable difference in the subjective understanding (means of 5.04 of ""positive"" vs. ""negative"" and 5.47 for ""abnormal"" vs. ""normal"" on a 7-point Likert scale; absolute mean difference 0.42 [95 % CI: 0.20; 0.64]) as well as in the subjective comprehension of the communicating physician (means of 4.49 for ""positive"" vs. ""negative"" and 4.95 for ""abnormal"" vs. ""normal"" on a 7-point Likert scale; absolute mean difference 0.45 [95% CI: 0.23; 0.67]). A higher level of comprehension for the words ""abnormal"" vs. ""normal"" was consistent across the overall sample. It is mainly people with no school-leaving certificate and a lower educational level who benefit from the changed wording.
CONCLUSIONS


In the process of communicating non-numerical medical test results, people without a medical background understand neutral, descriptive adjectives better than adjectives that are considered judgmental in everyday usage. A corresponding change of written and oral communication can easily be implemented by medical experts in their everyday practice and particularly supports a population group that already suffers disadvantages in the medical system.",2020,This relative difference of 20.4 % in the number of participants with a correct understanding is statistically significant (Chi square=13.061; p=0.001).,"['1,131 participants, representing the population of Germany with regard to age, gender, and educational level, were recruited via an online platform', 'people without a medical background']","['positive"" vs. ""negative"" (n=566) or ""abnormal"" vs. ""normal']","[""subjective and objective understanding of test results as well as the participants' subjective comprehension of the physician communicating with them"", 'subjective comprehension of the communicating physician']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0332287', 'cui_str': 'With'}]",1131.0,0.0492124,This relative difference of 20.4 % in the number of participants with a correct understanding is statistically significant (Chi square=13.061; p=0.001).,"[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Auschra', 'Affiliation': 'Freie Universität Berlin, Fachbereich Wirtschaftswissenschaft, Management-Department, Berlin, Deutschland.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Möller', 'Affiliation': 'Freie Universität Berlin, Fachbereich Wirtschaftswissenschaft, Marketing-Department, Berlin, Deutschland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Berthod', 'Affiliation': 'Jacobs University Bremen, Department of Business & Economics, Bremen, Deutschland.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Mazheika', 'Affiliation': 'Wagener-Stiftung für Sozialpädiatrie, Bremen, Deutschland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borusiak', 'Affiliation': 'Wagener-Stiftung für Sozialpädiatrie, Bremen, Deutschland; Universität Witten/Herdecke, Fakultät für Gesundheit, Department für Humanmedizin, Witten, Deutschland. Electronic address: peter.borusiak@gesundheitnord.de.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2020.07.007']
3078,32902572,A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery.,"BACKGROUND


This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials.
METHODS


A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality.
RESULTS


In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
CONCLUSIONS


This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.
EDITOR’S PERSPECTIVE


",2020,"Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
","['adult patients undergoing elective or semiurgent complex cardiothoracic surgery', 'high-risk cardiothoracic bleeding patients', 'adult patients undergoing complex cardiothoracic surgery', 'Complex Cardiothoracic Surgery']","['cold-stored platelets', 'standard room temperature-stored platelets', 'Platelets Stored Cold']","['median chest drain output', 'clinical effect measured by chest drain output', 'Total blood usage, number of adverse events, length of stay in intensive care, and mortality', 'platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality', 'Platelet aggregation', 'cold storage time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.187777,"Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
","[{'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Strandenes', 'Affiliation': ''}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Sivertsen', 'Affiliation': ''}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Bjerkvig', 'Affiliation': ''}, {'ForeName': 'Theodor K', 'Initials': 'TK', 'LastName': 'Fosse', 'Affiliation': ''}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Cap', 'Affiliation': ''}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Del Junco', 'Affiliation': ''}, {'ForeName': 'Einar Klæboe', 'Initials': 'EK', 'LastName': 'Kristoffersen', 'Affiliation': ''}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Haaverstad', 'Affiliation': ''}, {'ForeName': 'Venny', 'Initials': 'V', 'LastName': 'Kvalheim', 'Affiliation': ''}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Braathen', 'Affiliation': ''}, {'ForeName': 'Turid Helen Felli', 'Initials': 'THF', 'LastName': 'Lunde', 'Affiliation': ''}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Hervig', 'Affiliation': ''}, {'ForeName': 'Karl Ove', 'Initials': 'KO', 'LastName': 'Hufthammer', 'Affiliation': ''}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': ''}, {'ForeName': 'Torunn Oveland', 'Initials': 'TO', 'LastName': 'Apelseth', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003550']
3079,32847397,Eight weeks of device-guided slow breathing decreases sympathetic nervous reactivity to stress in posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by increased risk for developing hypertension and cardiovascular disease. We recently showed that device-guided slow breathing (DGB) acutely lowers blood pressure (BP) and muscle sympathetic activity (MSNA) and improves baroreflex sensitivity (BRS) in PTSD. The aim of this study was to assess the long-term benefits of DGB on autonomic function at rest and during stress. We hypothesized that long-term DGB improves arterial BRS and lowers BP and MSNA in PTSD. Twenty-five veterans with PTSD were studied and randomized to either 8 wk of daily DGB ( n  = 12) or 8 wk of sham device (Sham;  n  = 13). BP, heart rate (HR), and MSNA were measured at rest and during mental math. Arterial BRS was assessed using the modified Oxford technique. Resting MSNA, BP, and heart rate (HR) remained comparable before and after 8 wk in both groups (DGB and Sham). Likewise, the change in sympathetic and cardiovagal BRS was not different between the groups. Interestingly, DGB significantly decreased MSNA reactivity to mental math when expressed as burst frequency ( P  = 0.012) or burst incidence ( P  = 0.008) compared with Sham, suggesting a sustained effect of DGB on sympathetic reactivity to stress in PTSD. Contrary to our hypothesis, long-term DGB did not lower systolic BP, diastolic BP, or HR responses to stress compared with Sham. Likewise, pulse pressure reactivity after 8 wk ( P  = 0.121) was also comparable. In summary, these data suggest that long-term use of DGB may lead to a sustained dampening of sympathetic reactivity to mental stress in PTSD.",2020,"Contrary to our hypothesis, long-term DGB did not lower systolic BP, diastolic BP or HR responses to stress compared to sham.","['Post-Traumatic Stress Disorder', 'Twenty-five Veterans with PTSD', 'Posttraumatic stress disorder (PTSD']","['DGB', 'Device Guided Slow Breathing', 'daily DGB', 'device-guided slow breathing (DGB']","['systolic BP, diastolic BP or HR responses to stress', 'BP, heart rate (HR) and MSNA', 'arterial BRS, lower BP and MSNA', 'MSNA reactivity to mental math', 'Arterial BRS', 'autonomic function', 'Resting MSNA, BP and heart rate (HR', 'Likewise, pulse pressure reactivity', 'sympathetic and cardiovagal BRS', 'blood pressure (BP) and muscle sympathetic activity (MSNA) and improves baroreflex sensitivity (BRS']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",25.0,0.0315964,"Contrary to our hypothesis, long-term DGB did not lower systolic BP, diastolic BP or HR responses to stress compared to sham.","[{'ForeName': 'Ida T', 'Initials': 'IT', 'LastName': 'Fonkoue', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Yingtian', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public Health, Atlanta, Georgia.'}, {'ForeName': 'Toure', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Vemulapalli', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Sprick', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rothbaum', 'Affiliation': 'Psychiatry and Behavioral Sciences, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jeanie', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Renal Division, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00079.2020']
3080,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
3081,32856285,"Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial.","BACKGROUND


The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation.
OBJECTIVES


The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN.
METHODS


A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone.
RESULTS


Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality.
CONCLUSION


Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings.
REGISTRATION


Pan African Clinical Trial Registry identifier number PACTR201902691230243.",2020,The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups.,"['severe persistent pulmonary hypertension (PPHN', 'neonates with PPHN', 'neonates with severe PPHN', 'neonates with PPHN were divided into three groups of 20 patients each: group 1 received', 'Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings']","['sildenafil', 'sildenafil and milrinone', 'oral sildenafil starting at 0.5\xa0mg/kg every 6\xa0h to a target maintenance dose of 2\xa0mg/kg every 6\xa0h; group 2 received intravenous milrinone 0.5\xa0μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone', 'milrinone', 'Milrinone Plus Sildenafil']","['mortality', 'pulmonary artery systolic pressure', 'oxygenation index']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}]",,0.401337,The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups.,"[{'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'El-Ghandour', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Bahaa', 'Initials': 'B', 'LastName': 'Hammad', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghanem', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manal A M', 'Initials': 'MAM', 'LastName': 'Antonios', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt. malakmanal@yahoo.com.'}]",Paediatric drugs,['10.1007/s40272-020-00412-4']
3082,32857616,Four weeks of vitamin D supplementation improves nitric oxide-mediated microvascular function in college-aged African Americans.,"Reduced nitric oxide (NO)-mediated cutaneous vasodilation, secondary to increased oxidative stress, presents in young African American (AA) compared with European American (EA) adults and may be modulated by vitamin D status. We assessed cutaneous microvascular function in 18 young, healthy (21 ± 2 yr; 9 men, 9 women) subjects before (pre, 8 AA, 10 EA) 4 wk of 2,000 IU/day oral vitamin D supplementation and in 13 subjects after (post, 7 AA, 6 EA) 4 wk of 2,000 IU/day oral vitamin D supplementation. Serum vitamin D concentrations [25(OH)D] were measured at each visit. Three intradermal microdialysis fibers placed in the ventral forearm were randomized for treatment with 10 μM Tempol, 100 μM apocynin, or lactated Ringer's solution (control). Local heating (39°C) induced cutaneous vasodilation; red cell flux was measured at each site (laser-Doppler flowmetry), and cutaneous vascular conductance (CVC = flux/MAP) was expressed as a percentage of maximum (28 mM sodium nitroprusside, +43°C) for each phase of local heating. After stable elevated blood flow was attained, 15 mM  N G -nitro-l-arginine methyl ester (l-NAME; NO synthase inhibitor) was perfused at all sites to quantify the NO contribution to cutaneous vasodilation (%NO), calculated as the difference between local heating and l-NAME plateaus. Serum [25(OH)D], the magnitude of the local heating response, and %NO were all lower in AAs versus EAs ( P  < 0.01). Tempol ( P  = 0.01), but not apocynin ( P  ≥ 0.19), improved the local heating response and %NO. Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AAs ( P  ≤ 0.04) but not in EAs ( P  ≥ 0.41). Vitamin D supplementation mitigated endothelial dysfunction, an antecedent to overt cardiovascular disease (CVD), in otherwise healthy, young AA adults. NEW & NOTEWORTHY  Endothelial dysfunction, an antecedent to overt cardiovascular disease (CVD), is observed earlier and more frequently in otherwise healthy African Americans (AAs) when compared with other ethnic groups. Vitamin D may modulate endothelial function, and darkened skin pigmentation increases risk of vitamin D deficiency. We show that 4 wk of 2,000 IU/day vitamin D supplementation improves microvascular responses to local heating in AAs. Ensuring adequate vitamin D status may mitigate development of cardiovascular dysfunction in this at-risk population.",2020,"Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41).","['college-aged African Americans', 'young African American (AA) compared to European American (EA) adults', '18 young, healthy (21±2 yr; 9 M, 9 F) subjects before (pre: 8 AA, 10 EA) and 13 subjects after (post: 7 AA, 6 EA) four weeks of 2,000']","['vitamin D supplementation', 'IU/day oral vitamin D supplementation', ""10 μM tempol, 100 μM apocynin, or lactated Ringer's (control"", 'Vitamin D supplementation']","['Serum vitamin D concentrations [25(OH)D', 'nitric oxide-mediated microvascular function', 'Serum [25(OH)D], the magnitude of the local heating response', 'serum [25(OH)D], the local heating response, and %NO in AA', 'cutaneous microvascular function', 'endothelial dysfunction', 'cutaneous vascular conductance (CVC=flux/MAP', 'Local heating (39˚C) induced cutaneous vasodilation; red cell flux', 'local heating response']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0045283', 'cui_str': 'tempol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0050465', 'cui_str': 'acetovanillone'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]",,0.051069,"Four weeks of supplementation improved serum [25(OH)D], the local heating response, and %NO in AA (p≤0.04), but not EA (p≥0.41).","[{'ForeName': 'S Tony', 'Initials': 'ST', 'LastName': 'Wolf', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Nina G', 'Initials': 'NG', 'LastName': 'Jablonski', 'Affiliation': 'Department of Anthropology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Ferguson', 'Affiliation': 'Department of Dermatology, The Penn State Hershey Medical Group, State College, Pennsylvania.'}, {'ForeName': 'Lacy M', 'Initials': 'LM', 'LastName': 'Alexander', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'W Larry', 'Initials': 'WL', 'LastName': 'Kenney', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00631.2020']
3083,32864848,Pharyngocutaneous fistulas after total laryngectomy or pharyngolaryngectomy: Place of video-fluoroscopic swallowing study.,"BACKGROUND


Specify place of video-fluoroscopic swallowing study (VFS) in the decision of oral refeeding after total pharyngolaryngectomy.
METHODS


At postoperative day 7, a blue dye testing was performed. If negative, a VFS was performed looking for a blind fistula. If this exam was negative, oral refeeding was started, but if a blind fistula was observed, cervical compression bandage was performed.
RESULTS


In 186 patients, a VFS was performed for 142 patients with negative blue dye testing. It was negative for 98 patients (69%) and positive for 44 patients (31%) (blind fistula). Patients had a probability of 7.1% to have a secondary pharyngocutaneous fistula (PCF) if the VFS was negative, and 15.9% if it was positive. No risk factor for the development of a secondary PCF or a blind fistula emerged from our analysis.
CONCLUSION


VFS should be performed before any oral refeeding in all patients operated with a total pharyngolaryngectomy.",2020,It was negative for 98 patients (69%) and positive for 44 patients (31%) (blind fistula).,"['186 patients, a VFS was performed for 142 patients with negative blue dye testing']","['total laryngectomy or pharyngolaryngectomy', 'video-fluoroscopic swallowing study (VFS']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3888792', 'cui_str': 'Swallow study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0441697', 'cui_str': 'Dye test'}]","[{'cui': 'C0189231', 'cui_str': 'Total laryngectomy'}, {'cui': 'C0189242', 'cui_str': 'Laryngopharyngectomy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3888792', 'cui_str': 'Swallow study'}]",[],142.0,0.0602961,It was negative for 98 patients (69%) and positive for 44 patients (31%) (blind fistula).,"[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Carsuzaa', 'Affiliation': 'Head and Neck Surgery, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Capitaine', 'Affiliation': 'Head and Neck Surgery, Hospital of La Rochelle, La Rochelle, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Ferrié', 'Affiliation': 'Radiology and Diagnostic Imaging, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Apert', 'Affiliation': 'Head and Neck Surgery, Hospital of Niort, Niort, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Tonnerre', 'Affiliation': 'Head and Neck Surgery, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Frasca', 'Affiliation': 'Anesthesiology, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Dufour', 'Affiliation': 'Head and Neck Surgery, University Hospital of Poitiers, Poitiers, France.'}]",Head & neck,['10.1002/hed.26429']
3084,32861500,Comparison of Continuous Infusion of Epinephrine and Phenylephrine on Hemodynamics During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial.,"PURPOSE


Phenylephrine is a commonly used vasopressor for the treatment of spinal-induced hypotension in obstetric patients, but it is associated with reflex bradycardia and a corresponding decrease in cardiac output. This study aims to assess the effectiveness of continuous epinephrine versus phenylephrine infusion in the prevention of postspinal maternal hypotension.
METHODS


Eighty-two women undergoing cesarean delivery were randomly divided into the epinephrine group (group E) and the phenylephrine group (group P). The patients received a continuous infusion of phenylephrine 1 μg kg -1  min -1  or epinephrine 0.1 μg kg -1  min -1  synchronously with intrathecal administration. Hemodynamic parameters were recorded, and umbilical cord blood gases were analyzed after delivery. The incidence of maternal hypotension, bradycardia, nausea, and vomiting was recorded.
FINDINGS


Blood pressure, heart rate, and cardiac output after spinal anesthesia induction were greater in group E than in group P (P < 0.05). In addition, there was a significant difference in the incidence of bradycardia (5% vs 22.5%, P = 0.02) and mean (SD) umbilical artery pH (7.31 [0.07] vs 7.28 [0.06], P = 0.04) between the groups.
IMPLICATIONS


With the dose of 0.1 μg kg -1  min -1 , infusion of epinephrine is more effective at maintaining blood pressure close to baseline during spinal anesthesia with a lower decrease in maternal heart rate and cardiac output compared with phenylephrine. Epinephrine may be superior to phenylephrine in terms of the incidence of bradycardia and umbilical artery pH. chictr.org.cn identifier: ChiCTR-IIC-17010960.",2020,"FINDINGS


Blood pressure, heart rate, and cardiac output after spinal anesthesia induction were greater in group E than in group P (P < 0.05).","['During Spinal Anesthesia for Cesarean Delivery', 'obstetric patients', 'Eighty-two women undergoing cesarean delivery']","['epinephrine', 'epinephrine 0.1\xa0μg', 'Epinephrine', 'phenylephrine 1\xa0μg\xa0kg -1', 'phenylephrine', 'Phenylephrine', 'Epinephrine and Phenylephrine', 'phenylephrine infusion']","['maternal hypotension, bradycardia, nausea, and vomiting', 'maternal heart rate and cardiac output', 'incidence of bradycardia', 'Hemodynamics', 'mean (SD) umbilical artery pH', 'umbilical cord blood gases', 'Blood pressure, heart rate, and cardiac output after spinal anesthesia induction']","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",82.0,0.373908,"FINDINGS


Blood pressure, heart rate, and cardiac output after spinal anesthesia induction were greater in group E than in group P (P < 0.05).","[{'ForeName': 'Y B', 'Initials': 'YB', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical Universty, Linhai, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, Jiaxing, China. Electronic address: zhang650679@163.com.""}]",Clinical therapeutics,['10.1016/j.clinthera.2020.08.004']
3085,32862667,Colchicine in Patients With Acute Coronary Syndrome: The Australian COPS Randomized Clinical Trial.,"BACKGROUND


Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS.
METHODS


This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis.
RESULTS


A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group ( P =0.09, log-rank). There was a higher rate of total death (8 versus 1;  P =0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0;  P =0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%).
CONCLUSIONS


The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality. Registration: URL: https://www.anzctr.org.au; Unique identifier: ACTRN12615000861550.",2020,,['Patients with Acute Coronary Syndrome'],['Colchicine'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}]",[],,0.107838,,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Tong', 'Affiliation': ""St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., A.W., J.L.).""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Quinn', 'Affiliation': 'Swinburne University of Technology, Department of Health Science and Biostatistics, Hawthorn, Victoria, Australia (S.Q.).'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Nasis', 'Affiliation': 'MonashHeart, Monash Health, Clayton, Victoria, Australia (A.N.).'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Hiew', 'Affiliation': 'Barwon Health, University Hospital Geelong, Victoria, Australia (C.H., J.A.).'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Roberts-Thomson', 'Affiliation': 'Royal Hobart Hospital, Tasmania, Australia (P.R.-T., H.A.).'}, {'ForeName': 'Heath', 'Initials': 'H', 'LastName': 'Adams', 'Affiliation': 'Royal Hobart Hospital, Tasmania, Australia (P.R.-T., H.A.).'}, {'ForeName': 'Rumes', 'Initials': 'R', 'LastName': 'Sriamareswaran', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., R.S., N.M.H., J.L.).'}, {'ForeName': 'Nay M', 'Initials': 'NM', 'LastName': 'Htun', 'Affiliation': 'Cardiology, Department of Medicine, Peninsula Health, Frankston, Victoria, Australia (D.C.T., R.S., N.M.H., J.L.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilson', 'Affiliation': 'Royal Melbourne Hospital, Parkville, Victoria, Australia (W.W.).'}, {'ForeName': 'Dion', 'Initials': 'D', 'LastName': 'Stub', 'Affiliation': 'Western Health, St Albans, Victoria, Australia (D.S.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'van Gaal', 'Affiliation': 'Northern Health, Epping, Victoria, Australia (W.v.G.).'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Howes', 'Affiliation': 'Gold Coast University Hospital, Southport, Queensland, Australia (L.H.).'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Collins', 'Affiliation': 'John Hunter Hospital, New Lambton Heights, New South Wales, Australia (N.C.).'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Yong', 'Affiliation': 'Concord Repatriation General Hospital, New South Wales, Australia (A.Y.).'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, St Leonards, New South Wales, Australia (R.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Whitbourn', 'Affiliation': ""St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., A.W., J.L.).""}, {'ForeName': 'Astin', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Wollongong Hospital, New South Wales, Australia (A.L.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hengel', 'Affiliation': 'Ballarat Health Services, Victoria, Australia (C.H.).'}, {'ForeName': 'Kaleab', 'Initials': 'K', 'LastName': 'Asrress', 'Affiliation': 'Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia (K.A.).'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Freeman', 'Affiliation': 'Eastern Health, Box Hill, Victoria, Australia (M.F.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Amerena', 'Affiliation': 'Barwon Health, University Hospital Geelong, Victoria, Australia (C.H., J.A.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': ""St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., A.W., J.L.).""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Layland', 'Affiliation': ""St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia (D.C.T., R.W., A.W., J.L.).""}]",Circulation,['10.1161/CIRCULATIONAHA.120.050771']
3086,32869564,Acute Cystitis Symptom Score questionnaire for measuring patient-reported outcomes in women with acute uncomplicated cystitis: Clinical validation as part of a phase III trial comparing antibiotic and nonantibiotic therapy.,"PURPOSE


The Acute Cystitis Symptom Score (ACSS) used in a clinical trial comparing the phytodrug Canephron®N (BNO 1045) with an antibacterial agent (fosfomycin trometamol [FT]) in the treatment of acute uncomplicated cystitis (AC) in women was evaluated as a patient-reported outcome measure in a  post hoc  analysis.
MATERIALS AND METHODS


This double-blind, randomized, multicenter, phase III noninferiority trial was performed in 51 centers in Europe. The ACSS questionnaire was used to assess severity and course of symptoms.
RESULTS


The  post hoc  analysis included 325 patients treated with BNO 1045 and 332 patients treated with FT (total of 657 patients). The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9). Predefined thresholds using the scoring system of the ACSS could be established and validated to define ""clinical cure.""
CONCLUSIONS


Evaluating not only antibacterial but also nonantibacterial agents indicated for the treatment of AC in women, clinical criteria for diagnostics, and measures of patient-reported outcomes are more important as main objectives than microbiological criteria. In this  post hoc  evaluation, we showed that the ACSS questionnaire, validated in several languages, has the potential to be used as a suitable instrument for diagnostics and patient-reported outcomes in well-designed, international, clinical studies investigating different treatment modalities of uncomplicated urinary tract infections.",2020,"The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9).","['325 patients treated with BNO 1045 and 332 patients treated with FT (total of 657 patients', 'women with acute uncomplicated cystitis', 'acute', '51 centers in Europe']",['phytodrug Canephron®N (BNO 1045) with an antibacterial agent (fosfomycin trometamol [FT'],"['Acute Cystitis Symptom Score questionnaire', 'mean sum-scores of the ACSS-typical domain', 'uncomplicated cystitis (AC']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C5198800', 'cui_str': 'BNO 1045'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0054586', 'cui_str': 'canephron N'}, {'cui': 'C5198800', 'cui_str': 'BNO 1045'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}]","[{'cui': 'C0149523', 'cui_str': 'Acute cystitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",1045.0,0.0417035,"The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9).","[{'ForeName': 'Jakhongir F', 'Initials': 'JF', 'LastName': 'Alidjanov', 'Affiliation': 'Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Overesch', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Abramov-Sommariva', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hoeller', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Steindl', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Florian M', 'Initials': 'FM', 'LastName': 'Wagenlehner', 'Affiliation': 'Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany.'}, {'ForeName': 'Kurt G', 'Initials': 'KG', 'LastName': 'Naber', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany. kurt@nabers.de.'}]",Investigative and clinical urology,['10.4111/icu.20200060']
3087,32873496,The Protective Impact of Telemedicine on Persons With Dementia and Their Caregivers During the COVID-19 Pandemic.,"OBJECTIVES


Social distancing under the COVID-19 pandemic has restricted access to community services for older adults with neurocognitive disorder (NCD) and their caregivers. Telehealth is a viable alternative to face-to-face service delivery. Telephone calls alone, however, may be insufficient. Here, we evaluated whether supplementary telehealth via video-conferencing platforms could bring additional benefits to care-recipient with NCD and their spousal caregivers at home.
PARTICIPANTS


Sixty older adults NCD-and-caregiver dyads were recruited through an activity center.
DESIGN, INTERVENTION


The impact of additional services delivered to both care-recipient and caregiver through video conference (n = 30) was compared with telehealth targeted at caregivers by telephone only (n = 30), over 4 weeks in a pretest-post-test design. Interviews and questionnaires were conducted at baseline and study's end.
MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50). It also reversed the falling trend in quality of life observed in the telephone only group (QoL-AD, η p 2  = 0.23). Varying degrees of improvements in physical and mental health (Short-Form 36 v2), perceived burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale) were observed among caregivers in the video-conferencing group, which were absent in the telephone-only group (η p 2  = 0.23-0.51).
CONCLUSION


Telemedicine by video conference was associated with improved resilience and wellbeing to both people with NCD and their caregivers at home. The benefits were visible already after 4 weeks and unmatched by telephone alone. Video conference as the modus operandi of telehmedicine beyond the context of pandemic-related social distancing should be considered.",2020,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","['Persons With Dementia and Their Caregivers During the COVID-19 Pandemic', 'Sixty older adults NCD-and-caregiver dyads were recruited through an activity center', 'older adults with neurocognitive disorder (NCD) and their caregivers']","['additional services delivered to both care-recipient and caregiver through video conference (n\u202f=\u202f30) was compared with telehealth targeted at caregivers by telephone', 'Telemedicine']","['physical and mental health', 'quality of life', 'burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale', 'Montreal Cognitive Assessment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",60.0,0.061643,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department (EWHY), Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Salvation Army Hong Kong & Macau Command, Tai Po Multi-service Centre for Senior Citizen.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Women's Welfare Club Western District, Hong Kong Chung Hok Elderly Centre, Hong Kong, China.""}, {'ForeName': 'Daniel Ting-Hoi', 'Initials': 'DT', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Yee', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.07.019']
3088,32873500,Young Adults Have Worse Outcomes Than Older Adults: Secondary Analysis of a Medication Trial for Opioid Use Disorder.,"PURPOSE


Young adults are disproportionately affected by the current opioid crisis. Although medications for opioid use disorder are broadly effective, with reductions in morbidity and mortality, the particular effectiveness of medications for opioid use disorder among young adults is less well understood.
METHODS


This secondary analysis compared young adults (aged 18-25 years) with older adults (aged ≥26 years) in a large comparative effectiveness trial (""XBOT"") that randomized subjects to extended-release naltrexone or sublingual buprenorphine-naloxone for 6 months. Opioid relapse was defined by opioid use over four consecutive weeks or seven consecutive days, using urine testing and self-report.
RESULTS


Among subjects in the intention-to-treat sample (n = 570, all randomized participants), a main effect of age group was found, with higher relapse rates among young adults (70.3%) compared with older adults (58.2%), with an odds ratio of 1.72 (95% confidence interval = 1.08-2.70), p = .02. In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06). Among the intention-to-treat sample, survival analysis revealed a significant time-by-age group interaction (p = .01) with more relapse over time in young adults. No significant interactions between age and medication group were detected.
CONCLUSIONS


Young adults have increased rates of relapse compared with older adults, perhaps because of vulnerabilities that increase their risk for treatment dropout and medication nonadherence, regardless of medication assignment. These results suggest that specialized, developmentally informed interventions may be needed to improve retention and successful treatment of opioid use disorder among young adults.",2020,"In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06).","['Young Adults', 'Older Adults', 'young adults (aged 18-25 years) with older adults (aged ≥26 years', 'Young adults']",['naltrexone or sublingual buprenorphine-naloxone'],"['morbidity and mortality', 'rates of relapse', 'Opioid relapse', 'relapse rates']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.141861,"In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06).","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Mountain Manor Treatment Center/Maryland Treatment Centers, Baltimore, Maryland; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: mfishman@marylandtreatment.org.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wenzel', 'Affiliation': 'Mountain Manor Treatment Center/Maryland Treatment Centers, Baltimore, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Division of Mental Health Data Science, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.038']
3089,32880493,"STUDY PROTOCOL - pulsed radiofrequency in addition to transforaminal epidural steroid injection in patients with acute and subacute sciatica due to lumbosacral disc herniation: rationale and design of a phase III, multicenter, randomized, controlled trial.","Lumbosacral disc herniation (LDH) represents the most common cause of sciatica. Currently, there is limited evidence about minimally invasive interventional therapies for the treatment of this condition. This paper presents the protocol for a multicenter, prospective, randomized, controlled, phase III trial evaluating if PRF in addition to TFESI leads to better outcomes in patients with sciatica due to LDH, compared to TFESI alone, during the first year after treatment (Pulsed Radiofrequency in Addition to TFESI for Sciatica [PRATS]). Eligible patients are between 18 and 75 years of age, suffer from sciatica of less than 12-week duration with pain intensity >4 on the Visual Analogue Scale (VAS) and have unilateral LDH compatible with symptoms at MRI. The Medical Ethics Committee of participating hospitals approved the study protocol. Patients will be randomized to receive either combined treatment (PRF and TFESI) or TFESI alone. The primary outcome will be the assessment of pain intensity with VAS at different timepoints from week-1 to 52 after treatment; secondary outcomes will include Roland Disability Questionnaire for sciatica and Oswestry Disability Index, evaluated at 4, 12 and 52 weeks. The follow-up will last 52 weeks for each patient. Statistical analysis will be performed on a per-protocol basis.",2020,"The primary outcome will be the assessment of pain intensity with VAS at different timepoints from week-1 to 52 after treatment; secondary outcomes will include Roland Disability Questionnaire for sciatica and Oswestry Disability Index, evaluated at 4, 12 and 52 weeks.","['Eligible patients are between 18 and 75\xa0years of age, suffer from sciatica of less than 12-week duration with pain intensity >4 on the Visual Analogue Scale (VAS) and have unilateral LDH compatible with symptoms at MRI', 'patients with sciatica due to LDH', 'Lumbosacral disc herniation (LDH', 'patients with acute and subacute sciatica due to lumbosacral disc herniation']","['transforaminal epidural steroid injection', 'TFESI', 'combined treatment (PRF and TFESI) or TFESI alone']","['Roland Disability Questionnaire for sciatica and Oswestry Disability Index', 'pain intensity with VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4728111', 'cui_str': 'Lumbosacral disc herniation'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.126928,"The primary outcome will be the assessment of pain intensity with VAS at different timepoints from week-1 to 52 after treatment; secondary outcomes will include Roland Disability Questionnaire for sciatica and Oswestry Disability Index, evaluated at 4, 12 and 52 weeks.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Scipione', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I - Sapienza University of Rome , Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Alfieri', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I - Sapienza University of Rome , Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Maio', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I - Sapienza University of Rome , Rome, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Panella', 'Affiliation': 'Spine Unit, Centro SaNa Servizi Sanitari , Aprilia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Napoli', 'Affiliation': 'Spine Unit, Centro SaNa Servizi Sanitari , Aprilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': 'Spine Unit, Centro SaNa Servizi Sanitari , Aprilia, Italy.'}, {'ForeName': 'Nunziante', 'Initials': 'N', 'LastName': 'Pandaloro', 'Affiliation': 'Spine Unit, Centro SaNa Servizi Sanitari , Aprilia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bazzocchi', 'Affiliation': 'Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli , Bologna, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Facchini', 'Affiliation': 'Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli , Bologna, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Albisinni', 'Affiliation': 'Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli , Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Spinnato', 'Affiliation': 'Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli , Bologna, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Catalano', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I - Sapienza University of Rome , Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Napoli', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences, Policlinico Umberto I - Sapienza University of Rome , Rome, Italy.'}]",Expert review of medical devices,['10.1080/17434440.2020.1815529']
3090,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
3091,32885518,Effect of reminiscence therapy based on positive psychology theory (RTBPPT) on the positive feelings of the spousal caregivers of elderly patients with advanced cancer in China.,"BACKGROUND


Elderly patients with advanced cancer often experience various symptoms and need a great amount of care. However, their spousal caregivers are prone to negative emotions because of old age, poor health and the heavy burden of care.
OBJECTIVE


To examine the effect of a reminiscence therapy (RT) intervention on the spousal caregivers of elderly patients with advanced cancer.
METHODS


This study was a randomised controlled trial. Fifty-six spousal caregivers were randomly assigned to the control group (N = 29) receiving usual care and the experimental group (N = 27) receiving the RT intervention. The caregivers' caregiving burden, positive feelings towards caregiving and hope were measured before and immediately after the intervention.
RESULTS


The experimental group showed a significant reduction in the burden of spousal care compared to the control group (p < .01). The experimental group also had higher levels of positive feelings and hope than did the control group (p < .01).
CONCLUSION


RT is an effective approach to reducing the care burden of spouses of elderly patients with advanced cancer and enhancing the spouses' positive feelings and hope.",2020,"The experimental group also had higher levels of positive feelings and hope than did the control group (p < .01).
","['Elderly patients with advanced cancer', 'elderly patients with advanced cancer in China', 'spousal caregivers of elderly patients with advanced cancer', 'Fifty-six spousal caregivers', 'elderly patients with advanced cancer']","['reminiscence therapy (RT) intervention', 'RT', 'reminiscence therapy based on positive psychology theory (RTBPPT', 'control group (N\xa0=\xa029) receiving usual care and the experimental group (N\xa0=\xa027) receiving the RT intervention']","['higher levels of positive feelings', 'burden of spousal care']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0150321', 'cui_str': 'Reminiscence therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",56.0,0.0545229,"The experimental group also had higher levels of positive feelings and hope than did the control group (p < .01).
","[{'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'School of Nursing, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Department of Oncology, The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China.""}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianjing', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Fujian Provincial Hospital, Fuzhou, China.'}]",European journal of cancer care,['10.1111/ecc.13324']
3092,32888318,Higher order aberrations and axial elongation in combined 0.01% atropine with orthokeratology for myopia control.,"PURPOSE


To compare the changes in higher order aberrations (HOA's) for photopic and mesopic pupil diameters in children undergoing orthokeratology treatment (OK) or combined 0.01% atropine with orthokeratology treatment (AOK), and their association with axial elongation.
METHODS


Children aged 6 to <11 years with 1.00-4.00 D of myopia were randomly assigned to each treatment group. Photopic and mesopic pupil diameters were quantified using automated pupillometry and HOA's were measured with a Hartmann-Shack aberrometer and Badal system to control for accommodation. HOA's were rescaled to photopic and mesopic pupil diameters and fitted with a 6 th  order Zernike polynomial expansion. Axial length was measured using an optical biometer under cycloplegia.
RESULTS


Baseline and six-month data from 25 AOK and 28 OK participants were analysed. At the six-month visit, pupil diameter was larger in the AOK group under photopic conditions (3.70 ± 0.42 vs 3.12 ± 0.33 mm, p < 0.001), along with a range of HOA metrics [3 rd  to 6 th  order and higher order root mean square error values (HO RMS), all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03). Axial elongation was greater in the OK treatment group (0.05 ± 0.08 vs -0.01 ± 0.12 mm, p = 0.02). In the AOK group, axial elongation was correlated with the increase in photopic pupil diameter (r = -0.45, p = 0.02) and with several HOA metrics; however, these associations were not observed in the OK group.
CONCLUSION


AOK treatment resulted in increased photopic pupil size and HOA's, and significantly less axial elongation over a six-month period compared to OK treatment alone. The improved myopia control observed with combination 0.01% atropine and orthokeratology may be a result of an enhanced optical effect due to a larger photopic pupil size.",2020,"all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03).","['Children aged 6 to <11\xa0years with 1.00-4.00 D of myopia', 'children undergoing orthokeratology treatment (OK) or combined 0.01']","['atropine with orthokeratology treatment (AOK', 'atropine']","['Axial elongation', 'axial elongation', 'Photopic and mesopic pupil diameters', 'photopic pupil diameter', ""photopic pupil size and HOA's"", 'pupil diameter', 'Axial length', 'root mean square error values (HO RMS', 'Higher order aberrations and axial elongation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517393', 'cui_str': '0.01'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0626994,"all p ≤ 0.003] and individual Zernike terms (primary spherical aberration, and oblique quadrafoil, both p ≤ 0.03).","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Vincent', 'Affiliation': 'Contact Lens and Visual Optics Laboratory, School of Optometry and Vision Science, Centre for Vision and Eye Research, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Alex L K', 'Initials': 'ALK', 'LastName': 'Ng', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'George P M', 'Initials': 'GPM', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Laser Eye Centre, Hong Kong, Hong Kong.'}, {'ForeName': 'Victor C P', 'Initials': 'VCP', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12730']
3093,32889413,Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial.,"STUDY OBJECTIVE


To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.
DESIGN


This was a prospective, randomized, controlled study.
SETTING


The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.
PATIENTS


146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.
INTERVENTION


Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO 2 ) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB.
MEASUREMENTS


The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.
MAIN RESULTS


128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001).
CONCLUSIONS


In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.",2020,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","['high-risk surgical patients', 'high-risk patients undergoing cardiac surgery', 'The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018', '146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled']","['individualized goal-directed therapy', 'cardiac surgery, individualized GDT therapy', 'individualized goal-directed therapy (GDT', 'individualized GDT group or usual care group']","['mean arterial pressure (MAP', 'Early morbidity', 'morbidity', 'cerebral oxygen balance', 'regional cerebral oxygen saturation (rScO 2 ) level', 'bispectral index (BIS', 'composite endpoint of 30-day mortality and major postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.315518,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","[{'ForeName': 'Xin-Qi', 'Initials': 'XQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_mz_cheng@126.com.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacology, Anhui Medical University, 230032 Hefei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'You-Mei', 'Initials': 'YM', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Er-Wei', 'Initials': 'EW', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_guew_mz@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110032']
3094,32892222,"A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects.","BACKGROUND


Clostridioides difficile infection is the most common cause of healthcare-associated infections in the USA, with limited treatment options. Ibezapolstat is a novel DNA polymerase IIIC inhibitor with in vitro activity against C. difficile.
OBJECTIVES AND METHODS


Randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of ibezapolstat in healthy volunteers. Microbiome changes associated with ibezapolstat were compared with vancomycin over a 10 day course using shotgun metagenomics.
RESULTS


A total of 62 subjects aged 31 ± 7 years (45% female; average BMI: 25 ± 3 kg/m2) were randomized. Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period. In the multiday, multiple-dose arm, baseline microbiota was comparable between subjects that received ibezapolstat compared with vancomycin. At Day 10 of dosing, differential abundance analysis and β-diversity demonstrated a distinct difference between the microbiome in subjects given vancomycin compared with either dose of ibezapolstat (P = 0.006). α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
CONCLUSIONS


Ibezapolstat was shown to be safe and well tolerated, with minimal systemic exposure, high stool concentrations and a distinct microbiome profile compared with oral vancomycin. These results support further clinical development of ibezapolstat for patients with C. difficile infection.",2020,"α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
","['62 subjects aged 31\u2009±\u20097\u2009years (45% female; average BMI: 25\u2009±\u20093\u2009kg/m2', 'patients with C. difficile infection', 'healthy volunteers', 'healthy subjects']","['placebo', 'Ibezapolstat', 'vancomycin', 'ibezapolstat']","['minimal systemic absorption', 'safety, tolerability and pharmacokinetics', 'α-Diversity changes', 'safe and well tolerated', 'safety, pharmacokinetics and food and faecal microbiome effects']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C3850076', 'cui_str': 'Absorption, Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",62.0,0.388054,"α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
","[{'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Garey', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Khurshida', 'Initials': 'K', 'LastName': 'Begum', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lancaster', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gonzales-Luna', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Dinh', 'Initials': 'D', 'LastName': 'Bui', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mercier', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Seng Yue', 'Affiliation': 'Learn and Confirm Inc., Montreal, Canada.'}, {'ForeName': 'Murray P', 'Initials': 'MP', 'LastName': 'Ducharme', 'Affiliation': 'Learn and Confirm Inc., Montreal, Canada.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Silverman', 'Affiliation': 'Acurx Pharmaceuticals LLC, White Plains, NY, USA.'}, {'ForeName': 'M Jahangir', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa364']
3095,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
3096,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
3097,32897437,"Open randomized trial of the effects of 6% hydroxyethyl starch 130/0.4/9 and 5% albumin on safety profile, volume efficacy, and glycocalyx degradation in hepatic and pancreatic surgery.","PURPOSE


The aim of this study was to evaluate the effects of hydroxyethyl starch (HES) 130/0.4/9 compared to 5% albumin on renal and coagulation safety profiles, volume efficacy and glycocalyx degradation in major abdominal surgery.
METHODS


The study was approved by the institutional ethics committee as a single center, open-labeled randomized trial. Fifty patients undergoing hepatic or pancreatic surgery were randomly assigned to the HES group (n = 25), who received HES 130/0.4/9, or the Albumin group (n = 25), who received 5% albumin. Ringer's acetate solution (3 ml/kg/h) and colloid solution (2 mL/kg/h) were infused and goal-directed fluid management was performed to stabilize hemodynamics. Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups. Blood loss and requirements for transfusion and vasoactive agents were also examined. Statistical analysis was performed by Mann-Whitney U tests, chi-square or Fisher exact test, with P < 0.05 taken to be significant.
RESULTS


Serum creatinine levels did not differ between the HES and Albumin groups (median: 0.67 vs. 0.75 mg/dL at anesthesia induction, 0.82 vs. 0.83 mg/dL at ICU admission, 0.67 vs. 0.73 mg/dL one day after surgery, 0.68 vs. 0.70 mg/dL one month after surgery). NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents did not differ between the groups.
CONCLUSION


HES 130/0.4/9 can be used as safely and effectively as 5% albumin. Glycocalyx degradation did not differ between use of these solutions in major abdominal surgery.",2020,"Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups.","['Fifty patients undergoing hepatic or pancreatic surgery', 'hepatic and pancreatic surgery', 'major abdominal surgery']","['6% hydroxyethyl starch', ""Ringer's acetate solution (3\xa0ml/kg/h) and colloid solution"", 'HES 130/0.4/9, or the Albumin group (n\u2009=\u200925), who received 5% albumin', 'hydroxyethyl starch (HES', 'HES']","['serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers', 'Blood loss and requirements for transfusion and vasoactive agents', 'Serum creatinine levels', 'renal and coagulation safety profiles, volume efficacy and glycocalyx degradation', 'safety profile, volume efficacy, and glycocalyx degradation', 'Glycocalyx degradation', 'NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1532580', 'cui_str': 'mL/kg/hr'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0001057', 'cui_str': 'N-Acetyl-beta-glucosaminidase'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",50.0,0.0937781,"Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups.","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan. tsuzuki@saitama-med.ac.jp.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Koyama', 'Affiliation': 'Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02847-y']
3098,32906825,Velocity Loss Thresholds Reliably Control Kinetic and Kinematic Outputs during Free Weight Resistance Training.,"Exercise velocity and relative velocity loss thresholds (VLTs) are commonly used in velocity-based resistance training. This study aims to quantify the between-day reliability of 10%, 20%, and 30% VLTs on kinetic and kinematic outputs, changes in external load, and repetition characteristics in well-trained athletes. Using a repeated, counter-balanced crossover design, twelve semi-professional athletes completed five sets of the back squat with an external load corresponding to a mean concentric velocity of ~0.70 m·s -1  and a VLT applied. The testing sessions were repeated after four weeks of unstructured training to assess the long-term reliability of each VLT. A coefficient of variation (CV) <10% was used to classify outputs as reliable. Kinetic and kinematic outputs and external load were largely reliable, with only peak power during sets 2-5 within the 10% VLT condition demonstrating a CV >10% (CV: 11.14-14.92%). Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%). These findings demonstrate that by utilizing VLTs, kinetic and kinematic outputs can be prescribed and replicated across training mesocycles. Thus, for practitioners wishing to reliably control the kinetic and kinematic stimulus that is being applied to their athletes, it is advised that a velocity-based approach is used.",2020,"Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%).",['well-trained athletes'],[],"['Kinetic and kinematic outputs and external load', 'kinetic and kinematic outputs, changes in external load, and repetition characteristics', 'Exercise velocity and relative velocity loss thresholds (VLTs']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.0261417,"Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%).","[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción, Concepción 2850, Chile.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ramirez-Lopez', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds LS6 3GZ, West Yorkshire, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dalton-Barron', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds LS6 3GZ, West Yorkshire, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Weakley', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186509']
3099,32908192,Infant gut microbiota characteristics generally do not modify effects of lipid-based nutrient supplementation on growth or inflammation: secondary analysis of a randomized controlled trial in Malawi.,"An unhealthy gut microbial community may act as a barrier to improvement in growth and health outcomes in response to nutritional interventions. The objective of this analysis was to determine whether the infant microbiota modified the effects of a randomized controlled trial of lipid-based nutrient supplements (LNS) in Malawi on growth and inflammation at 12 and 18 months, respectively. We characterized baseline microbiota composition of fecal samples at 6 months of age (n = 506, prior to infant supplementation, which extended to 18 months) using 16S rRNA gene sequencing of the V4 region. Features of the gut microbiota previously identified as being involved in fatty acid or micronutrient metabolism or in outcomes relating to growth and inflammation, especially in children, were investigated. Prior to correction for multiple hypothesis testing, the effects of LNS on growth appeared to be modified by Clostridium (p-for-interaction = 0.02), Ruminococcus (p-for-interaction = 0.007), and Firmicutes (p-for-interaction = 0.04) and effects on inflammation appeared to be modified by Faecalibacterium (p-for-interaction = 0.03) and Streptococcus (p-for-interaction = 0.004). However, after correction for multiple hypothesis testing these findings were not statistically significant, suggesting that the gut microbiota did not alter the effect of LNS on infant growth and inflammation in this cohort.",2020,An unhealthy gut microbial community may act as a barrier to improvement in growth and health outcomes in response to nutritional interventions.,"['fecal samples at 6\xa0months of age (n\u2009=\u2009506, prior to infant supplementation, which extended to 18\xa0months) using 16S rRNA gene sequencing of the V4 region']","['lipid-based nutrient supplements (LNS', 'lipid-based nutrient supplementation', 'LNS']",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",[],,0.124015,An unhealthy gut microbial community may act as a barrier to improvement in growth and health outcomes in response to nutritional interventions.,"[{'ForeName': 'Riley L', 'Initials': 'RL', 'LastName': 'Hughes', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre 3, Malawi.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaima', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Chikondi', 'Initials': 'C', 'LastName': 'Malamba-Banda', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Kable', 'Affiliation': 'Immunity and Disease Prevention, Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA. kgdewey@ucdavis.edu.'}]",Scientific reports,['10.1038/s41598-020-71922-x']
3100,32908282,Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes.,"Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals 1 . This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n = 54) or by physicians (physician arm, n = 54). The results for the primary efficacy measure-the percentage of time spent within the target glucose range (70-180 mg dl -1  (3.9-10.0 mmol l -1 ))-in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P < 1 × 10 -7 ). The percentage of readings below 54 mg dl -1  (<3.0 mmol l -1 ) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 ± 1.4% versus 1.0 ± 0.9%, respectively, P < 0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.",2020,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","['youths with type 1 diabetes', '108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no']","['Insulin dose optimization using an automated artificial intelligence-based decision support system', 'remote insulin dose adjustment every three weeks guided by either an AI-DSS', 'frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS']","['percentage of time spent within the target glucose range', 'severe hypoglycemia, one diabetic ketoacidosis']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",108.0,0.0687685,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","[{'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, One Joslin Place, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Slover', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'Pediatric Endocrinology & Diabetes, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents, Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. mosheph@tauex.tau.ac.il.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature medicine,['10.1038/s41591-020-1045-7']
3101,32909815,Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the current study was to introduce and measure the effectiveness of a new 3D-printed nasoalveolar molding (D-NAM) appliance on improving the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair.
DESIGN


A prospective, balanced, randomized, parallel groups, single-blinded, controlled trial.
SETTING


All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt.
PARTICIPANTS


Thirty-four, nonsyndromic infants with UCLP.
INTERVENTIONS


The eligible infants were randomly assigned into either no-treatment (control) or to the new D-NAM groups. In D-NAM group, the maxillary models were 3D scanned into virtual models onto which segmentation and alveolar segments approximation were performed. Approximation movements were divided into 3 models representing 3 activation steps. On each of these models, virtual appliance construction was performed followed by 3D printing of the appliance. Nasal stent was added manually to the appliances of the second and third steps. Horizontal tapes were applied to infants in the D-NAM group only.
MAIN OUTCOMES MEASURES


A Blinded assessors carried all the MADs measurements virtually on digital models collected at the beginning (T1) and after (T2) treatment.
RESULTS


Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group.
CONCLUSIONS


The introduced D-NAM/3D-printed appliance is a simple and efficient technique to improve the MADs in infants with UCLP before surgical lip repair.",2020,"Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group.
","['Thirty-four, nonsyndromic infants with UCLP', 'Unilateral Cleft Lip and Palate Infants', 'All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt', 'infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair', 'infants with UCLP before surgical lip repair']","['no-treatment (control) or to the new D-NAM', 'Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM', 'new 3D-printed nasoalveolar molding (D-NAM) appliance']",['measured MADs'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027366', 'cui_str': 'Namibia'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0305097,"Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abd El-Ghafour', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mamdouh A', 'Initials': 'MA', 'LastName': 'Aboulhassan', 'Affiliation': 'Department of Pediatric Plastic Surgery, Faculty of Medicine, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mona M Salah', 'Initials': 'MMS', 'LastName': 'Fayed', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr Ragab', 'Initials': 'AR', 'LastName': 'El-Beialy', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Faten Hussein Kamel', 'Initials': 'FHK', 'LastName': 'Eid', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Seif El-Din', 'Initials': 'SE', 'LastName': 'Hegab', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Gendi', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, 63526Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dawlat', 'Initials': 'D', 'LastName': 'Emara', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, 63526Cairo University, Cairo, Egypt.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620954321']
3102,32909921,CPAP combined with oral appliance therapy reduces CPAP requirements and pharyngeal pressure swings in obstructive sleep apnea.,"Oral appliance (OA) therapy is the leading alternative to continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA). It is well tolerated compared with CPAP. However, ≥50% of patients using OA therapy have incomplete resolution of their OSA. Combination therapy with CPAP and oral appliance (CPAP + OA) is a potential alternative for incomplete responders to OA therapy. This study aimed to determine the extent to which combination therapy reduces therapeutic CPAP requirements using gold-standard physiological methodology in those who have an incomplete response to OA therapy alone. Sixteen incomplete responders [residual apnea/hypopnea index (AHI) > 10 events/h] to a novel OA with a built-in oral airway were recruited (3 women:13 men, aged 31-65 yr, body mass index: 22-38 kg/m 2 , residual AHI range: 13-63 events/h). Participants were fitted with a nasal mask, pneumotachograph, epiglottic pressure catheter, and standard polysomnography equipment. CPAP titrations were performed during non-rapid eye movement (NREM) supine sleep in each participant during three conditions (order randomized): CPAP only, CPAP + OA (oral airway open), and CPAP + OA (oral airway closed). OSA was resolved at pressures of 4 ± 2 and 5 ± 2 cmH 2 O during CPAP + OA (oral airway open) and CPAP + OA (oral airway closed) conditions versus 8 ± 2 cmH 2 O during CPAP only ( P  < 0.01). Negative epiglottic pressure swings in oral airway open and closed conditions were normalized to CPAP only levels [-2.5(-3.7, -2.6) vs. -2.3(-3.2, -2.4) vs. -2.1(-2.7, -2.3) cmH 2 O]. Combined CPAP and OA therapy reduces therapeutic CPAP requirements by 35%-45% and minimizes epiglottic pressure swings. This combination may be a therapeutic alternative for patients with incomplete responses to OA therapy alone and those who cannot tolerate high CPAP levels. NEW & NOTEWORTHY  Combined CPAP and oral appliance therapy has been suggested as an alternative for incomplete responders to oral appliance therapy. We used a novel oral appliance incorporating an oral airway together with CPAP to show that pharyngeal pressure swings were normalized at reduced CPAP levels. Our findings demonstrate that using CPAP and oral appliance together may be a beneficial alternative for incomplete responders to oral appliance therapy and intolerant CPAP users due to high-pressure requirements.",2020,"Negative epiglottic pressure swings in oral airway open and closed conditions were normalized to CPAP only levels (-2.5[-3.7,-2.6] vs. -2.3[-3.2,-2.4]vs.","['Oral appliance (OA', ' 10events/h) to a novel OA with a built-in oral airway were recruited (3F:13M, aged 31-65 years, BMI: 22-38kg/m 2 , residual AHI range 13-63events/h', 'those who have an incomplete response to OA therapy alone', 'obstructive sleep apnea', '16 incomplete responders (residual AHI', 'obstructive sleep apnea (OSA']","['CPAP and OA therapy', 'CPAP combined with oral appliance therapy', 'OA therapy', 'CPAP and oral appliance (CPAP+OA', 'nasal mask, pneumotachograph, epiglottic pressure catheter and standard polysomnography equipment']","['incomplete resolution of their OSA', 'Negative epiglottic pressure swings', 'therapeutic CPAP requirements', 'OSA', 'CPAP requirements and pharyngeal pressure swings']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150694', 'cui_str': 'Oropharyngeal airway device'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0182334', 'cui_str': 'Pneumotachograph'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}]",,0.0155132,"Negative epiglottic pressure swings in oral airway open and closed conditions were normalized to CPAP only levels (-2.5[-3.7,-2.6] vs. -2.3[-3.2,-2.4]vs.","[{'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Tong', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Tran', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH) and Flinders Health and Medical Research Institute (FHMRI), Flinders University, Adelaide, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ricciardiello', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Donegan', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}, {'ForeName': 'Alan K I', 'Initials': 'AKI', 'LastName': 'Chiang', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Szollosi', 'Affiliation': 'The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Amatoury', 'Affiliation': 'Biomedical Engineering Program, Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00393.2020']
3103,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2021,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
3104,32863014,[Effect of acupuncture on the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES


Postoperative nausea and vomiting (PONV) is a common and undesirable complication observed after laparoscopic cholecystectomy (LC). We investigated the effects of auriculoacupuncture (AA) on the prevention of postoperative nausea and vomiting in the immediate postoperative period of uncomplicated laparoscopic cholecystectomy.
METHODS


Sixty-eight patients were randomly divided into two groups, auriculoacupuncture (n = 35) and control (n = 33) and then they were evaluated prospectively. The needle was placed before anaesthesia induction and remained for 20 minutes. Nausea intensity was evaluated using an analogic visual scale and PONV events were registered immediately after anaesthesia care unit admission and in the second, fourth and sixth hours after the surgery.
RESULTS


The auriculoacupuncture group had a significantly smaller incidence of nausea and vomiting than the control group throughout the whole postoperative period (16/35 vs. 27/33, p = 0.03 and 4/35 vs. 15/33, p = 0.005, respectively); the AA group had fewer nausea events 2hours (p = 0.03) and 6hours (p = 0.001) after surgery and fewer vomiting events 2hours (p = 0.01) and 6hours (p = 0.02) after surgery.
CONCLUSIONS


Auriculoacupuncture can partially prevent postoperative nausea and vomiting when compared to metoclopramide alone after uncomplicated laparoscopic cholecystectomy. Auriculoacupuncture can be recommended as an adjuvant therapy for postoperative nausea and vomiting prevention in selected patients.",2020,"The auriculoacupuncture group had a significantly smaller incidence of nausea and vomiting than the control group throughout the whole postoperative period (16/35 vs. 27/33, p = 0.03 and 4/35 vs. 15/33, p = 0.005, respectively); the AA group had fewer nausea events 2hours (p = 0.03) and 6hours (p = 0.001) after surgery and fewer vomiting events 2hours (p = 0.01) and 6hours (p = 0.02) after surgery.
","['Sixty-eight patients', 'n = 35) and control (n = 33) and then they were evaluated prospectively']","['laparoscopic cholecystectomy', 'Auriculoacupuncture', 'auriculoacupuncture (AA', 'acupuncture', 'metoclopramide', 'laparoscopic cholecystectomy (LC', 'auriculoacupuncture']","['vomiting events', 'postoperative nausea and vomiting', 'nausea and vomiting', 'analogic visual scale and PONV events', 'Nausea intensity', 'nausea events']","[{'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",68.0,0.0365912,"The auriculoacupuncture group had a significantly smaller incidence of nausea and vomiting than the control group throughout the whole postoperative period (16/35 vs. 27/33, p = 0.03 and 4/35 vs. 15/33, p = 0.005, respectively); the AA group had fewer nausea events 2hours (p = 0.03) and 6hours (p = 0.001) after surgery and fewer vomiting events 2hours (p = 0.01) and 6hours (p = 0.02) after surgery.
","[{'ForeName': 'Luiz Eduardo', 'Initials': 'LE', 'LastName': 'Miranda', 'Affiliation': 'Universidade de Pernambuco (UPE), Hospital Universitário Oswaldo Cruz, Divisão de Cirurgia Geral e Transplante de Fígado, Recife, PE, Brasil. Electronic address: lecmiranda@gmail.com.'}, {'ForeName': 'Luiz de França Maia E Silva', 'Initials': 'LFMES', 'LastName': 'Filho', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brasil.'}, {'ForeName': 'Ana Carolina Brainer de', 'Initials': 'ACB', 'LastName': 'Siqueira', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brasil.'}, {'ForeName': 'Ana Clara', 'Initials': 'AC', 'LastName': 'Miranda', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brasil.'}, {'ForeName': 'Bianca Rodrigues Castelo Branco', 'Initials': 'BRCB', 'LastName': 'Rocha', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brasil.'}, {'ForeName': 'Ian Victor Paiva de', 'Initials': 'IVP', 'LastName': 'Lima', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brasil.'}, {'ForeName': 'Victor Soares Gomes da', 'Initials': 'VSGD', 'LastName': 'Silva', 'Affiliation': 'Universidade de Pernambuco (UPE), Faculdade de Ciências Médicas, Recife, PE, Brasil.'}, {'ForeName': 'Diego Laurentino de', 'Initials': 'DL', 'LastName': 'Lima', 'Affiliation': 'Universidade de Pernambuco (UPE), Hospital Universitário Oswaldo Cruz, Divisão de Cirurgia Geral e Transplante de Fígado, Programa de Pós-Graduação de Medicina, Recife, PE, Brasil.'}, {'ForeName': 'Holmes', 'Initials': 'H', 'LastName': 'Naspollini', 'Affiliation': 'Universidade de Pernambuco (UPE), Hospital Universitário Oswaldo Cruz, Divisão de Cirurgia Geral e Transplante de Fígado, Recife, PE, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.08.001']
3105,32870583,Central encoding of the strength of intranasal chemosensory trigeminal stimuli in a human experimental pain setting.,"An important measure in pain research is the intensity of nociceptive stimuli and their cortical representation. However, there is evidence of different cerebral representations of nociceptive stimuli, including the fact that cortical areas recruited during processing of intranasal nociceptive chemical stimuli included those outside the traditional trigeminal areas. Therefore, the aim of this study was to investigate the major cerebral representations of stimulus intensity associated with intranasal chemical trigeminal stimulation. Trigeminal stimulation was achieved with carbon dioxide presented to the nasal mucosa. Using a single-blinded, randomized crossover design, 24 subjects received nociceptive stimuli with two different stimulation paradigms, depending on the just noticeable differences in the stimulus strengths applied. Stimulus-related brain activations were recorded using functional magnetic resonance imaging with event-related design. Brain activations increased significantly with increasing stimulus intensity, with the largest cluster at the right Rolandic operculum and a global maximum in a smaller cluster at the left lower frontal orbital lobe. Region of interest analyses additionally supported an activation pattern correlated with the stimulus intensity at the piriform cortex as an area of special interest with the trigeminal input. The results support the piriform cortex, in addition to the secondary somatosensory cortex, as a major area of interest for stimulus strength-related brain activation in pain models using trigeminal stimuli. This makes both areas a primary objective to be observed in human experimental pain settings where trigeminal input is used to study effects of analgesics.",2020,"Brain activations increased significantly with increasing stimulus intensity, with the largest cluster at the right Rolandic operculum and a global maximum in a smaller cluster at the left lower frontal orbital lobe.",['24 subjects received'],"['intranasal chemical trigeminal stimulation', 'nociceptive stimuli', 'carbon dioxide']","['Brain activations', 'Stimulus-related brain activations']",[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",24.0,0.0402107,"Brain activations increased significantly with increasing stimulus intensity, with the largest cluster at the right Rolandic operculum and a global maximum in a smaller cluster at the left lower frontal orbital lobe.","[{'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Lötsch', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Oertel', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Felden', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Nöth', 'Affiliation': 'Brain Imaging Center, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Deichmann', 'Affiliation': 'Brain Imaging Center, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}]",Human brain mapping,['10.1002/hbm.25190']
3106,32873681,Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma.,"INTRODUCTION


Mesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.
METHODS AND ANALYSIS


The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
ETHICS AND DISSEMINATION


Research ethics approval was granted by London - Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


ISRCTN-ISRCTN44351742 and ClinicalTrials.gov-NCT02040272.",2020,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"['pleural mesothelioma', 'patients with malignant pleural mesothelioma']","['surgery-(extended) pleurectomy decortication-versus no surgery', 'pleurectomy decortication versus no (extended) pleurectomy decortication']","['health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years', 'survival and/or quality of life', 'quality of life', 'survival', 'overall survival', 'median survival']","[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152463', 'cui_str': 'Pleurectomy'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.206517,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Academic Division of Thoracic Surgery, Royal Brompton and Harefield NHS Trust, London, UK e.lim@rbht.nhs.uk.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'The Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Cardiothoracic Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Cancer Research UK Centre Leicester, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Department of Medicine, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': 'Department of Thoracic Oncology, Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waller', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Ali', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bille', 'Affiliation': ""Thoracic Surgery, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Fuller', 'Affiliation': 'Respiratory Medicine, South Tyneside NHS Foundation Trust, South Shields, UK.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Ionescu', 'Affiliation': 'Lung Cancer, Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Keni', 'Affiliation': 'Oncology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Department of Thoracic Surgery, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Pek', 'Initials': 'P', 'LastName': 'Koh', 'Affiliation': 'Department of Oncology, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Mansy', 'Affiliation': 'Oncology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Milton', 'Affiliation': 'Thoracic Surgery Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Dakshinamoorthy', 'Initials': 'D', 'LastName': 'Muthukumar', 'Affiliation': 'Oncology, Colchester Hospital University NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Pope', 'Affiliation': 'Clatterbridge Cancer Centre, Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Plymouth Oncology Centre, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shamash', 'Affiliation': 'Department of Medical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Tasigiannopoulos', 'Affiliation': 'The Oncology Care Team, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Treece', 'Affiliation': 'Heamatology and Oncology Unit, North West Anglia NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Joyce', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Warnes', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stokes', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038892']
3107,32871029,"High-dose dexamethasone plus recombinant human thrombopoietin vs high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia: A prospective, multicenter, randomized trial.","We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), vs HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. So, HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P < .001) and complete response (CR, 75.0% vs 42.7%, P < .001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs 36.5%, P = .02; sustained CR: 46.0% vs 32.3%, P = .043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = .04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044.",2020,"Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis.","['newly diagnosed adult immune thrombocytopenia (ITP) patients', 'One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set', 'newly diagnosed adult primary immune thrombocytopenia', 'newly diagnosed ITP patients']","['dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone', 'DXM', 'DXM plus rhTPO or DXM monotherapy', 'dexamethasone', 'dexamethasone plus recombinant human thrombopoietin']","['initial response and yielded favorable SR', 'Response rate', 'efficacy and safety', 'initial response', 'overall duration of response', 'tolerated', 'complete response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.108466,"Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis.","[{'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Qin', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Wenzheng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Binzhou Medical University Hospital, Binzhou, China.'}, {'ForeName': 'Xinhong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Xinjiang Uiger Municipal People's Hospital, Urumqi, China.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': 'Department of Hematology, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Hematology, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Military General Hospital, Jinan, China.'}, {'ForeName': 'Zhaogang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Taian City Central Hospital, Taian, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Zhencheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Zibo Central Hospital, Zibo, China.'}, {'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Ran', 'Affiliation': ""Department of Hematology, Weifang People's Hospital, Weifang, China.""}, {'ForeName': 'Hongguo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Linyi People's Hospital, Linyi, China.""}, {'ForeName': 'Kehong', 'Initials': 'K', 'LastName': 'Bi', 'Affiliation': 'Department of Hematology, Shandong Provincial Qianfoshan Hospital, Jinan, China.'}, {'ForeName': 'Daqi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Chenglu', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Hematology, Qilu Hospital (Qingdao), Shandong University, Qingdao, China.'}, {'ForeName': 'Ruirong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Weihai Municipal Hospital, Weihai, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Zhejiang Provincial Hospital of TCM, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xin-Guang', 'Initials': 'XG', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}]",American journal of hematology,['10.1002/ajh.25989']
3108,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
3109,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
3110,32882390,Timing of Oral P2Y 12  Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.,"BACKGROUND


Although oral P2Y 12  inhibitors are key in the management of patients with non-ST-segment elevation acute coronary syndrome, the optimal timing of their administration is not well defined.
OBJECTIVES


The purpose of this study was to compare downstream and upstream oral P2Y 12  inhibitors administration strategies in patients with non-ST-segment elevation acute coronary syndrome undergoing invasive treatment.
METHODS


We performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit).
RESULTS


We randomized 1,449 patients to downstream or upstream oral P2Y 12  inhibitor administration. A pre-specified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes; nonfatal myocardial infarction or nonfatal stroke; and Bleeding Academic Research Consortium type 3, 4, and 5 bleeding through day 30, did not differ significantly between the downstream and upstream groups (percent absolute risk reduction: -0.46; 95% repeated confidence interval: -2.90 to 1.90). These results were confirmed among patients undergoing percutaneous coronary intervention (72% of population) and regardless of the timing of coronary angiography (within or after 24 h from enrollment).
CONCLUSIONS


Downstream and upstream oral P2Y 12  inhibitor administration strategies were associated with low incidence of ischemic and bleeding events and minimal numeric difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of 1 strategy over the other. (Downstream Versus Upstream Strategy for the Administration of P2Y 12  Receptor Blockers In Non-ST Elevated Acute Coronary Syndromes With Initial Invasive Indication [DUBIUS]; NCT02618837).",2020,"The rate of the primary endpoint, a composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings through day 30, did not differ significantly between the downstream and upstream groups (Absolute Risk Reduction (ARR%) -0.46","['NSTE-ACS patients undergoing invasive management', 'Patients in the downstream group undergoing percutaneous coronary intervention (PCI', 'Non-ST Elevation Acute Coronary Syndrome', 'patients with non-ST elevation acute coronary syndrome (NSTE-ACS', '1449 patients to downstream or upstream oral P2Y 12  inhibitor administration']","['ticagrelor or prasugrel', 'ticagrelor before angiography (upstream group) or no pre-treatment (downstream group']","['low incidence of ischemic and bleeding events', 'composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings', 'efficacy and safety events']","[{'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1449.0,0.116843,"The rate of the primary endpoint, a composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings through day 30, did not differ significantly between the downstream and upstream groups (Absolute Risk Reduction (ARR%) -0.46","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy. Electronic address: giuseppe.tarantini.1@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mojoli', 'Affiliation': 'Azienda Sanitaria Friuli Occidentale, Ospedale Santa Maria degli Angeli, Pordenone, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Ospedali Riuniti, Rivoli, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Caporale', 'Affiliation': ""Ospedale Civile dell'Annunziata, Cosenza, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rigattieri', 'Affiliation': 'Sandro Pertini Hospital, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Andò', 'Affiliation': 'Azienda Ospedaliera Universitaria Policlinico ""Gaetano Martino,"" Messina, Italy.'}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'Cirillo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pierini', 'Affiliation': 'Ospedale Bassini, Cinisello Balsamo, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Rimini, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sganzerla', 'Affiliation': 'ASST Bergamo Ovest, Ospedale di Treviglio, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Cacciavillani', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Babuin', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'De Cesare', 'Affiliation': 'Policlinico San Marco, Zingonia, Italy.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Limbruno', 'Affiliation': 'Azienda Ospedaliera Grosseto, Grosseto, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Massoni', 'Affiliation': 'Ospedale Universitario ""Maggiore della Carità,"" Novara, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rognoni', 'Affiliation': 'Ospedale S. Spirito, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pavan', 'Affiliation': 'Azienda Sanitaria Friuli Occidentale, Ospedale Santa Maria degli Angeli, Pordenone, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Belloni', 'Affiliation': 'Ospedale S. Spirito, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cernetti', 'Affiliation': 'Ospedale di Treviso ULSS 2, Treviso, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Favero', 'Affiliation': 'Ospedale di Treviso ULSS 2, Treviso, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saia', 'Affiliation': ""University Hospital of Bologna Sant'Orsola-Malpighi, Bologna, Italy.""}, {'ForeName': 'Luca Nai', 'Initials': 'LN', 'LastName': 'Fovino', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Masiero', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Roncon', 'Affiliation': 'Hospital Santa Maria della Misericordia, Rovigo, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gasparetto', 'Affiliation': 'Ca Ospedale P.Pederzoli, Peschiera del Garda, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ferlini', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ronco', 'Affiliation': ""Ospedale dell'Angelo, Mestre, Italy.""}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rossini', 'Affiliation': 'SS. Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Canova', 'Affiliation': 'Dipartimento Cardiovascolare, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Trabattoni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Russo', 'Affiliation': 'ASST Valle Olona, Presidio Ospedaliero San Antonio Abate, Gallarate, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Penzo', 'Affiliation': ""Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Ferrara, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Tarantino', 'Affiliation': 'Morgagni-Pierantoni Hospital, Forlì, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Mauro', 'Affiliation': 'Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Corrada', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Marchese', 'Affiliation': 'Anthea Hospital, GVM Care & Research, Bari, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Berti', 'Affiliation': 'Fondazione Toscana G. Monasterio, Ospedale del Cuore G. Pasquinucci, Massa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Martinato', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Danila', 'Initials': 'D', 'LastName': 'Azzolina', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Gregori', 'Affiliation': 'Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Musumeci', 'Affiliation': 'Division of Cardiology, Azienda Sanitaria Ospedaliera Ordine Mauriziano, Torino, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.08.053']
3111,32882399,Long QT syndrome type 1 and 2 patients respond differently to arrhythmic triggers: The TriQarr in vivo study.,"BACKGROUND


In patients with long QT syndrome (LQTS), swimming and loud noises have been identified as genotype-specific arrhythmic triggers in LQTS type 1 (LQTS1) and LQTS type 2 (LQTS2), respectively.
OBJECTIVE


The purpose of this study was to compare LQTS group responses to arrhythmic triggers.
METHODS


LQTS1 and LQTS2 patients were included. Before and after beta-blocker intake, electrocardiograms were recorded as participants (1) were exposed to a loud noise of ∼100 dB; and (2) had their face immersed into cold water.
RESULTS


Twenty-three patients (9 LQTS1, 14 LQTS2) participated. In response to noise, LQTS groups showed similarly increased heart rate, but LQTS2 patients had corrected QT interval (Fridericia formula) (QTcF) prolonged significantly more than LQTS1 patients (37 ± 8 ms vs 15 ± 6 ms; P = .02). After intake of beta-blocker, QTcF prolongation in LQTS2 patients was significantly blunted and similar to that of LQTS1 patients (P = .90). In response to simulated diving, LQTS groups experienced a heart rate drop of ∼28 bpm, which shortened QTcF similarly in both groups. After intake of beta-blockers, heart rate dropped to 28 ± 2 bpm in LQTS1 patients and 20 ± 3 bpm in LQTS2, resulting in a slower heart rate in LQTS1 compared with LQTS2 (P = .01). In response, QTcF shortened similarly in LQTS1 and LQTS2 patients (57 ± 9 ms vs 36 ± 7 ms; P = .10).
CONCLUSION


When exposed to noise, LQTS2 patients had QTc prolonged significantly more than did LQTS1 patients. Importantly, beta-blockers reduced noise-induced QTc prolongation in LQTS2 patients, thus demonstrating the protective effect of beta-blockers. In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta-blocker intake.",2020,"In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta blockers.",['patients with long QT syndrome (LQTS'],"['LQTS1', 'TriQarr', 'LQTS']","['noise-induced QTc prolongation', 'QTcF prolongation', 'heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023976', 'cui_str': 'Long QT syndrome'}]","[{'cui': 'C0023976', 'cui_str': 'Long QT syndrome'}]","[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",23.0,0.018453,"In response to simulated diving, LQTS groups responded similarly, but a slower heart rate was observed in LQTS1 patients during simulated diving after beta blockers.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marstrand', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark; Department of Emergency Medicine, Slagelse Hospital, Denmark. Electronic address: pmarstrand@hotmail.com.'}, {'ForeName': 'Kasim', 'Initials': 'K', 'LastName': 'Almatlouh', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Jørgen K', 'Initials': 'JK', 'LastName': 'Kanters', 'Affiliation': 'Laboratory of Experimental Cardiology, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Graff', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Alex Hørby', 'Initials': 'AH', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Theilade', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University Hospital of Copenhagen, Herlev, Denmark.'}]",Heart rhythm,['10.1016/j.hrthm.2020.08.017']
3112,32884045,The effect on clinical outcomes when targeting spinal manipulation at stiffness or pain sensitivity: a randomized trial.,"The mechanisms underlying pain relief following spinal manipulative therapy (SMT) are not understood fully although biomechanical and neurophysiological processes have been proposed. As such, we designed this randomized trial to elucidate the contributions of biomechanical and neurophysiological processes. A total of 132 participants with low back pain were randomly assigned to receive SMT at either the lumbar segment measured as the stiffest or the segment measured as having the lowest pain threshold. The primary outcome was patient reported low back pain intensity following treatment. Secondary outcomes were biomechanical stiffness and neurophysiological pressure pain threshold. All outcomes were measured at baseline, after the fourth and final session and at 2-weeks follow-up. Data were analyzed using linear mixed models, and demonstrated that the SMT application site did not influence patient reported low back pain intensity or stiffness. However, a large and significant difference in pressure pain threshold was observed between groups. This study provides support that SMT impacts neurophysiological parameters through a segment-dependent neurological reflex pathway, although this do not seem to be a proxy for improvement. This study was limited by the assumption that the applied treatment was sufficient to impact the primary outcome.",2020,"Data were analyzed using linear mixed models, and demonstrated that the SMT application site did not influence patient reported low back pain intensity or stiffness.",['132 participants with low back pain'],"['SMT', 'spinal manipulative therapy (SMT']","['low back pain intensity', 'pressure pain threshold', 'biomechanical stiffness and neurophysiological pressure pain threshold', 'low back pain intensity or stiffness']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",132.0,0.172307,"Data were analyzed using linear mixed models, and demonstrated that the SMT application site did not influence patient reported low back pain intensity or stiffness.","[{'ForeName': 'Casper Glissmann', 'Initials': 'CG', 'LastName': 'Nim', 'Affiliation': 'Medical Research Unit, Spine Centre of Southern Denmark, University Hospital of Southern Denmark, Odense, Denmark. casper.nim@rsyd.dk.'}, {'ForeName': 'Gregory Neil', 'Initials': 'GN', 'LastName': 'Kawchuk', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Schiøttz-Christensen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': ""O'Neill"", 'Affiliation': 'Medical Research Unit, Spine Centre of Southern Denmark, University Hospital of Southern Denmark, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-020-71557-y']
3113,32886108,Branched-Chain Amino Acid Fortification Does Not Restore Muscle Protein Synthesis Rates following Ingestion of Lower- Compared with Higher-Dose Mycoprotein.,"BACKGROUND


We have shown that ingesting a large bolus (70 g) of the fungal-derived, whole food mycoprotein robustly stimulates muscle protein synthesis (MPS) rates.
OBJECTIVE


The aim of this study was to determine if a lower dose (35 g) of mycoprotein enriched with branched-chain amino acids (BCAAs) stimulates MPS to the same extent as 70 g of mycoprotein in resistance-trained young men.
METHODS


Nineteen men [aged 22 ± 1 y, BMI (kg/m2): 25 ± 1] took part in a randomized, double-blind, parallel-group study. Participants received primed, continuous infusions of l-[ring-2H5]phenylalanine and ingested either 70 g mycoprotein (31.5 g protein; MYCO; n = 10) or 35 g BCAA-enriched mycoprotein (18.7 g protein: matched on BCAA content; ENR; n = 9) following a bout of unilateral resistance exercise. Blood and bilateral quadriceps muscle samples were obtained before exercise and protein ingestion and during a 4-h postprandial period to assess MPS in rested and exercised muscle. Two- and 3-factor ANOVAs were used to detect differences in plasma amino acid kinetics and mixed muscle fractional synthetic rates, respectively.
RESULTS


Postprandial plasma BCAA concentrations increased more rapidly and to a larger degree in ENR compared with MYCO. MPS increased with protein ingestion (P ≤ 0.05) but to a greater extent following MYCO (from 0.025% ± 0.006% to 0.057% ± 0.004% · h-1 in rested muscle, and from 0.024% ± 0.007% to 0.072% ± 0.005% · h-1 in exercised muscle; P < 0.0001) compared with ENR (from 0.031% ± 0.003% to 0.043% ± 0.005% · h-1 in rested muscle, and 0.027% ± 0.005% to 0.052% ± 0.005% · h-1 in exercised muscle; P < 0.01) ingestion. Postprandial MPS rates were greater in MYCO compared with ENR (P < 0.01).
CONCLUSIONS


The ingestion of lower-dose BCAA-enriched mycoprotein stimulates resting and postexercise MPS rates, but to a lesser extent compared with the ingestion of a BCAA-matched 70-g mycoprotein bolus in healthy young men. This trial was registered at clinicaltrials.gov as 660065600.",2020,"MPS increased with protein ingestion (P ≤ 0.05) but to a greater extent following MYCO (from 0.025% ± 0.006% to 0.057% ± 0.004% · h-1 in rested muscle, and from 0.024% ± 0.007% to 0.072% ± 0.005% · h-1 in exercised muscle; P < 0.0001) compared with ENR (from 0.031% ± 0.003% to 0.043% ± 0.005% · h-1 in rested muscle, and 0.027% ± 0.005% to 0.052% ± 0.005% · h-1 in exercised muscle; P < 0.01) ingestion.","['healthy young men', 'Nineteen men [aged 22\xa0±', 'resistance-trained young men']","['unilateral resistance exercise', 'mycoprotein enriched with branched-chain amino acids (BCAAs', 'l-[ring-2H5]phenylalanine and ingested either 70\xa0g mycoprotein (31.5\xa0g protein; MYCO; n\xa0=\xa010) or 35', 'Branched-Chain Amino Acid Fortification']","['postexercise MPS rates', 'Postprandial MPS rates', 'MPS increased with protein ingestion', 'Postprandial plasma BCAA concentrations', 'plasma amino acid kinetics and mixed muscle fractional synthetic rates']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0086376', 'cui_str': 'G protein'}]","[{'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.204425,"MPS increased with protein ingestion (P ≤ 0.05) but to a greater extent following MYCO (from 0.025% ± 0.006% to 0.057% ± 0.004% · h-1 in rested muscle, and from 0.024% ± 0.007% to 0.072% ± 0.005% · h-1 in exercised muscle; P < 0.0001) compared with ENR (from 0.031% ± 0.003% to 0.043% ± 0.005% · h-1 in rested muscle, and 0.027% ± 0.005% to 0.052% ± 0.005% · h-1 in exercised muscle; P < 0.01) ingestion.","[{'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Mariana O C', 'Initials': 'MOC', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Porter', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Doaa R', 'Initials': 'DR', 'LastName': 'Abdelrahman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Thomas S O', 'Initials': 'TSO', 'LastName': 'Jameson', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Tim J A', 'Initials': 'TJA', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd, Stokesly, United Kingdom.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa251']
3114,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE


Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS


Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS


176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS


Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
3115,32918588,Intra-individual physiological response of recreational runners to different training mesocycles: a randomized cross-over study.,"PURPOSE


Pronounced differences in individual physiological adaptation may occur following various training mesocycles in runners. Here we aimed to assess the individual changes in performance and physiological adaptation of recreational runners performing mesocycles with different intensity, duration and frequency.
METHODS


Employing a randomized cross-over design, the intra-individual physiological responses [i.e., peak ([Formula: see text]) and submaximal ([Formula: see text]) oxygen uptake, velocity at lactate thresholds (V 2 , V 4 )] and performance (time-to-exhaustion (TTE)) of 13 recreational runners who performed three 3-week sessions of high-intensity interval training (HIIT), high-volume low-intensity training (HVLIT) or more but shorter sessions of HVLIT (high-frequency training; HFT) were assessed.
RESULTS


[Formula: see text], V 2,  V 4  and TTE were not altered by HIIT, HVLIT or HFT (p > 0.05). [Formula: see text] improved to the same extent following HVLIT (p = 0.045) and HFT (p = 0.02). The number of moderately negative responders was higher following HIIT (15.4%); and HFT (15.4%) than HVLIT (7.6%). The number of very positive responders was higher following HVLIT (38.5%) than HFT (23%) or HIIT (7.7%). 46% of the runners responded positively to two mesocycles, while 23% did not respond to any.
CONCLUSION


On a group level, none of the interventions altered [Formula: see text], V 2 , V 4  or TTE, while HVLIT and HFT improved [Formula: see text]. The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT. 46% responded positively to two mesocycles, while 23% did not respond to any. These findings indicate that the magnitude of responses to HIIT, HVLIT and HFT is highly individual and no pattern was apparent.",2020,"The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT.","['recreational runners to different training mesocycles', '13 recreational runners', 'runners']","['high-intensity interval training (HIIT), high-volume low-intensity training (HVLIT) or more but shorter sessions of HVLIT (high-frequency training; HFT', 'submaximal ([Formula: see text]) oxygen uptake, velocity at lactate thresholds (V 2 , V 4 )] and performance (time-to-exhaustion (TTE']","['mean adaptation index', 'number of moderately negative responders', 'number of very positive responders']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0445362', 'cui_str': 'V 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0365246,"The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Düking', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany. Peter.dueking@uni-wuerzburg.de.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Swedish Winter Sports Research Centre, Department of Health Sciences, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kunz', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leppich', 'Affiliation': 'Chair of Software Engineering, Department of Computer Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Sperlich', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany.'}]",European journal of applied physiology,['10.1007/s00421-020-04477-4']
3116,32916607,Timing of randomization after an acute coronary syndrome in patients with type 2 diabetes mellitus.,"BACKGROUND


The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Understanding the timing and type of clinical events after an ACS will allow for clinicians to better tailor evidence-based treatments to optimize therapeutic effect. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes.
METHODS


EXAMINE was a randomized trial of alogliptin versus placebo in 5,380 patients with T2DM and a recent ACS from October 2009 to March 2013. The primary outcome was a composite of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8-34, 35-56, and 57-141 days.
RESULTS


Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs 33.0%), prior coronary artery bypass graft (9.6% vs 15.9%), or atrial fibrillation (5.9% vs 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio 1.47; 95% CI 1.21-1.74). Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
CONCLUSIONS


In a contemporary cohort of T2DM with a recent ACS, the risk for recurrent CV events including MI and HF hospitalization is elevated early after an ACS. Given the emergence of antihyperglycemic therapies that reduce the risk of MI and HF among patients with T2DM at high CV risk, future studies evaluating the initiation of these therapies in the early period following an ACS are warranted given the large burden of potentially modifiable CV events.",2020,"Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
","['patients with type 2 diabetes mellitus', 'patients with T2DM at high CV risk', '5,380 patients with T2DM and a recent ACS from October 2009 to March 2013', 'patients with type 2 diabetes mellitus (T2DM) post-ACS']",['alogliptin versus placebo'],"['risk of recurrent MI', 'atrial fibrillation', 'occurrence of subsequent CV events', 'prior coronary artery bypass graft', 'composite of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke', 'history of heart failure', 'HF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",5380.0,0.185278,"Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
","[{'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Elharram', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada; DREAM-CV Lab, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: Abhinav.sharma@mcgill.ca.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'University of Connecticut, Farmington, CT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Pritzker School of Medicine, Chicago, IL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Cambridge, MA; Cytel Corporation, Cambridge, MA, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}]",American heart journal,['10.1016/j.ahj.2020.07.014']
3117,32916609,Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design.,"Cardiovascular disease (CVD) is a major cause of morbidity and mortality. Although it has been widely appreciated that obesity is a major risk factor for CVD, treatments that produce effective, durable weight loss and the impact of weight reduction in reducing cardiovascular risk have been elusive. Instead, progress in CVD risk reduction has been achieved through medications indicated for controlling lipids, hyperglycemia, blood pressure, heart failure, inflammation, and/or thrombosis. Obesity has been implicated as promoting all these issues, suggesting that sustained, effective weight loss may have independent cardiovascular benefit. GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects. The GLP-1 RA semaglutide is in phase 3 studies as a medication for obesity treatment at a dose of 2.4 mg subcutaneously (s.c.) once weekly. Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) is a randomized, double-blind, parallel-group trial testing if semaglutide 2.4 mg subcutaneously once weekly is superior to placebo when added to standard of care for preventing major adverse cardiovascular events in patients with established CVD and overweight or obesity but without diabetes. SELECT is the first cardiovascular outcomes trial to evaluate superiority in major adverse cardiovascular events reduction for an antiobesity medication in such a population. As such, SELECT has the potential for advancing new approaches to CVD risk reduction while targeting obesity.",2020,"GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects.","['patients with established CVD and overweight or obesity but without diabetes', 'People With Overweight or Obesity (SELECT', 'Patients with Overweight or Obesity (SELECT']","['placebo', 'GLP-1 receptor agonists (RAs']","['Cardiovascular Outcomes', 'Heart Disease and Stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0928799,"GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects.","[{'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Deanfield', 'Affiliation': 'Farr Institute of Health Informatics Research at London, London, UK; National Institute for Cardiovascular Outcomes Research, University College London, London, United Kingdom.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Emerson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Health Heart and Vascular Institute, Kansas City, MO.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Plutzky', 'Affiliation': ""Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Brown-Frandsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marianne O L', 'Initials': 'MOL', 'LastName': 'Gronning', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark; Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Anders Gaarsdal', 'Initials': 'AG', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ravn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH. Electronic address: lincofa@ccf.org.'}]",American heart journal,['10.1016/j.ahj.2020.07.008']
3118,32916985,Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial.,"Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV 1 ). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI) .  We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)-an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions; or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.",2020,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).",['Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included'],"['Protocol', 'calorie-restricted Mediterranean dietary intervention', 'Low Calorie Mediterranean ']","['reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary', 'metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0628545,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Riggs', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Crowley', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Isabel R', 'Initials': 'IR', 'LastName': 'Young', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nayar', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sunseri', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Mena', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Ostrofsky', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Arul', 'Initials': 'A', 'LastName': 'Veerappan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Zeig-Owens', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Colbeth', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mengling', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Population Health, Division of Biostatistics, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Pompeii', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'St-Jules', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Prezant', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nolan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186569']
3119,32919110,Fibroblast growth factor 23 concentrations and modifying factors in children from age 12 to 24 months.,"BACKGROUND AND OBJECTIVES


Fibroblast growth factor 23 (FGF23) participates in phosphate, calcium and vitamin D metabolism. In children these interactions and modifying factors are largely unknown.
PARTICIPANTS AND METHODS


This study evaluates temporal changes and modifiers of FGF23 concentrations from 12 to 24 months, in healthy children, participating in a randomized vitamin D intervention (VIDI). Participants received vitamin D 3  of 10 or 30 μg/day from age 2 weeks to 24 months. At 12 and 24 months, growth measurements and venous blood samples were obtained for analyses of intact (iFGF23) and C-terminal FGF23 (cFGF23), 25-hydroxyvitamin D (25-OHD), calcium, phosphate, parathyroid hormone, iron and ferritin. Changes in FGF23 and modifying factors were examined by linear mixed models.
RESULTS


The study included 594 infants. Girls had higher iFGF23 than boys (p < 0.001 for both 12 and 24 months), cFGF23 did not differ between the sexes. Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p < 0.001) and from 45.2 to 42.5 pg/mL in girls (p = 0.002). Adjusted mean cFGF23 decreased from 2.89 to 2.00 pmol/L in boys (p < 0.001) and from 2.92 to 1.93 pmol/L in girls (p < 0.001). Iron modified FGF23 in both sexes, associating positively with iFGF23 and inversely with cFGF23. In girls, 25-OHD modified iFGF23. In boys, season modified FGF23, possibly through seasonal differences in 25-OHD. Vitamin D intervention dose did not affect FGF23.
CONCLUSIONS


FGF23 decreases from 12 to 24 months. Girls have higher iFGF23 than boys, at both time points. Iron modifies FGF23 in both sexes.",2020,Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002).,"['594 infants', 'healthy children, participating in a randomized vitamin D intervention (VIDI', 'children from age 12 to 24 months']","['Vitamin D intervention', 'vitamin D']","['intact (iFGF23) and C-terminal FGF23 (cFGF23), 25-hydroxyvitamin D (25-OHD), calcium, phosphate, parathyroid hormone, iron and ferritin', 'cFGF23', 'Adjusted mean cFGF23', 'Adjusted mean iFGF23', 'growth measurements and venous blood samples']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor 23, C-terminal'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",594.0,0.0908647,Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland. Electronic address: maria.enlund@helsinki.fi.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland; Center for Molecular Medicine, Karolinska Institutet, Clinical Genetics, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}]",Bone,['10.1016/j.bone.2020.115629']
3120,32919280,No benefit of HDL mimetic CER-001 on carotid atherosclerosis in patients with genetically determined very low HDL levels.,"BACKGROUND AND AIMS


Infusion of high-density lipoprotein (HDL) mimetics failed to induce regression of atherosclerosis in recent randomized clinical trials. However, patients in these previous trials had normal levels of HDL-cholesterol, which potentially limited efficacy. Patients with very low levels of HDL-cholesterol and impaired cholesterol efflux capacity can be expected to derive the most potential benefit from infusion of HDL mimetics. This randomized clinical trial evaluated the efficacy of infusions of the HDL mimetic CER-001 in patients with genetically determined very low levels of HDL cholesterol.
METHODS


In this multicenter, randomized clinical trial, we recruited patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants). Participants were randomized to intravenous infusions of 8 mg/kg CER-001 or placebo (2:1 ratio), comprising 9 weekly infusions followed by infusions every two weeks. Patients underwent repeated 3T-MRI to assess mean vessel wall area and  18 F-FDG PET/CT to quantify arterial wall inflammation.
RESULTS


A total of 30 patients with a mean age of 52.7 ± 7.4 years and HDL-cholesterol of 0.35 ± 0.25 mmol/L were recruited. After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21). Furthermore, there was no significant difference in carotid arterial wall inflammation (n = 24, treatment difference: 0.10 target-to-background ratio of the most diseased segment, p = 0.33) after 24 weeks.
CONCLUSION


In patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with HDL mimetic CER-001 did not reduce carotid vessel wall dimensions or arterial wall inflammation, compared with placebo.",2020,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","['patients with genetically determined very low HDL levels', 'patients with genetically determined very low levels of HDL cholesterol', '30 patients with a mean age of 52.7\xa0±\xa07.4 years and HDL-cholesterol of 0.35\xa0±\xa00.25\xa0mmol/L were recruited', 'patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with', 'patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants']","['placebo', 'HDL mimetic CER-001', 'intravenous infusions of 8\xa0mg/kg CER-001 or placebo', 'repeated 3T-MRI']","['carotid arterial wall inflammation', 'absolute change in mean vessel wall area', 'normal levels of HDL-cholesterol', 'carotid atherosclerosis', 'carotid vessel wall dimensions or arterial wall inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704429', 'cui_str': 'Familial hypoalphalipoproteinemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C3884609', 'cui_str': 'CER-001'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.409435,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","[{'ForeName': 'Kang H', 'Initials': 'KH', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Kaiser', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Casper C', 'Initials': 'CC', 'LastName': 'van Olden', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Sao Paulo, Brazil; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Dasseux', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Genest', 'Affiliation': 'Department of Medicine, Division of Cardiology, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, Utrecht University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Keyserling', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Center for Research, Prevention and Treatment of Atherosclerosis, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': 'Centres Hospitaliers Jolimont, La Louvière, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address: e.s.stroes@amsterdamumc.nl.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.004']
3121,32874098,Acute Effects of Winter Sports and Indoor Cycling on Arterial Stiffness.,"Sedentary lifestyle predisposes to endothelial dysfunction, increased arterial stiffness and cardiovascular diseases, all of which can be positively modified by regular physical exercise training. A decrease in physical activity during winter months coincides with higher rates of cardiovascular events. In order to identify winter sports suitable to overcome this seasonal exercise deficit and thus contribute to cardiovascular health, it was the aim of this study to compare immediate effects of cross-country skiing (XCS) and alpine skiing (AS) on arterial stiffness as an alternative to indoor cycling (IC). After baseline assessment, eighteen healthy subjects performed one session of XCS, AS, and IC in randomized order. Pulse wave analysis was conducted (Mobil-o-Graph ® ) before and 10-min after exercise. Parameters of arterial stiffness and wave reflection were reduced after XCS and IC, but not after AS: central systolic blood pressure (IC: -8.0 ± 5.4 mmHg; p < 0.001), amplitude of the backward pressure wave (IC: -1.4 ± 2.7 mmHg; p < 0.05), reflection coefficient (XCS: -6.0 ± 7.8%; IC: -5.7 ± 8.1%; both p < 0.1), and pulse wave velocity (IC by -0.19 ± 0.27 m/s; p < 0.01). Higher exercise intensities correlated with greater reductions of arterial stiffness (all p < 0.05). Single sessions of XCS, IC but not AS led to comparable improvement in arterial stiffness, which was even more pronounced during higher exercise intensities. With regard to arterial stiffness, IC and XCS emerge as more effective to counteract the winter exercise deficit and thus the deleterious cardiovascular effects of a sedentary lifestyle.",2020,"Parameters of arterial stiffness and wave reflection were reduced after XCS and IC, but not after AS: central systolic blood pressure (IC: -8.0 ± 5.4 mmHg; p < 0.001), amplitude of the backward pressure wave (IC: -1.4 ± 2.7 mmHg; p < 0.05), reflection coefficient (XCS: -6.0 ± 7.8%; IC: -5.7 ± 8.1%; both p < 0.1), and pulse wave velocity (IC by -0.19 ± 0.27 m/s; p < 0.01).",['eighteen healthy subjects'],"['Winter Sports and Indoor Cycling', 'cross-country skiing (XCS) and alpine skiing (AS']","['central systolic blood pressure', 'amplitude of the backward pressure', 'physical activity', 'Arterial Stiffness', 'arterial stiffness and cardiovascular diseases', 'arterial stiffness', 'arterial stiffness and wave reflection']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037264', 'cui_str': 'Skiing'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",18.0,0.0299208,"Parameters of arterial stiffness and wave reflection were reduced after XCS and IC, but not after AS: central systolic blood pressure (IC: -8.0 ± 5.4 mmHg; p < 0.001), amplitude of the backward pressure wave (IC: -1.4 ± 2.7 mmHg; p < 0.05), reflection coefficient (XCS: -6.0 ± 7.8%; IC: -5.7 ± 8.1%; both p < 0.1), and pulse wave velocity (IC by -0.19 ± 0.27 m/s; p < 0.01).","[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Austria.'}, {'ForeName': 'Edith E', 'Initials': 'EE', 'LastName': 'Müller', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schönfelder', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schwarzl', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mayr', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Stöggl', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stöggl', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Austria.'}]",Journal of sports science & medicine,[]
3122,32874103,Physiological Response Differences between Run and Cycle High Intensity Interval Training Program in Recreational Middle Age Female Runners.,"The aim of this investigation was to compare the changes in endurance running performance and physiological variables after a four-week period of high intensity interval training (HIIT) in either running or cycling in female athletes. Fourteen recreational female runners (age = 42 10 yr, height = 1.67 0.06 m, body mass = 61.6 10.4 kg, body mass index (BMI) = 22.2 3.4 kg.m -2 ) were randomly allocated to one of two HIIT training groups: running (HIIT run ) or cycling (HIIT bike ). Each group performed two HIIT sessions per week for 4 weeks, which consisted of 6 x 2 min at 95% of maximal heart rate (HR max ) and 4 x 1 min all out efforts. Maximal oxygen consumption (VO 2max ) in treadmill running increased significantly after the HIIT run  (p < 0.01, ES = 0.6) but remained unchanged in HIIT bike . However, HIIT bike  improved average velocity in a 10 km running time trial (TT run ) (p < 0.05, ES = -0.4), whereas, no changes were found for the HIIT run  group. Analysing the first and last HIIT sessions, for HIIT run  only the average rate of perceived exertion (RPE av ) increased significantly, whereas, performance variables such as average heart rate (HR av ) and average pace (pace av ) remained unchanged. HIIT bike  enhanced significantly the average speed of HIIT sets (speed av ) and the peak power output (PPO) of the session, as well as, the RPE av  and delayed onset muscle soreness immediately after HIIT session (DOMS post ) were increased significantly. A regime of HIIT in cycling may evoke increases in female recreational runners' power, which may be related with improvements in a 10 km TT run  independent of changes in aerobic capacity. This may be advantageous in order to avoid overuse running related injuries.",2020,"Maximal oxygen consumption (VO 2max ) in treadmill running increased significantly after the HIIT run  (p < 0.01, ES = 0.6) but remained unchanged in HIIT bike .","['female recreational runners', 'Fourteen recreational female runners (age = 42 10 yr, height = 1.67 0.06 m, body mass = 61.6 10.4 kg, body mass index (BMI) = 22.2 3.4', 'Recreational Middle Age Female Runners', 'female athletes']","['Run and Cycle High Intensity Interval Training Program', 'HIIT training groups: running (HIIT run ) or cycling (HIIT bike ', 'high intensity interval training (HIIT']","['Maximal oxygen consumption (VO 2max ) in treadmill running', 'average heart rate (HR av ) and average pace (pace av ', 'average speed of HIIT sets (speed av ) and the peak power output (PPO', 'average rate of perceived exertion (RPE av ', 'average velocity', 'RPE av  and delayed onset muscle soreness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517511', 'cui_str': '1.67'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",-2.0,0.0290883,"Maximal oxygen consumption (VO 2max ) in treadmill running increased significantly after the HIIT run  (p < 0.01, ES = 0.6) but remained unchanged in HIIT bike .","[{'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Mallol', 'Affiliation': 'Exercise Science, College of Nursing and Health Sciences, Flinders University, South Bedford Park, South Australia.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Exercise Science, College of Nursing and Health Sciences, Flinders University, South Bedford Park, South Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bentley', 'Affiliation': 'School of Environmental and Life Sciences Faculty of Science, University of Newcastle, Callaghan NSW, Australia.'}, {'ForeName': 'Gaizka', 'Initials': 'G', 'LastName': 'Mejuto', 'Affiliation': 'Department of Body Expression Didactics, University of the Basque Country, Sarriena Auzoa. Leioa, Spain.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Norton', 'Affiliation': 'School of Health Sciences, City East Campus, University of South Australia, Adelaide, South Australia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Yanci', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Education and Sport, University of Basque Country (UPV-EHU), Portal de Lasarte Kalea, Vitoria-Gasteiz, Spain.'}]",Journal of sports science & medicine,[]
3123,32874106,Computerized Cognitive Training with Minimal Motor Component Improves Lower Limb Choice-Reaction Time.,"The role of cognitive training in sports has experienced a recent surge in popularity. However, there is a paucity of longitudinal trials examining the effectiveness of related methods. This study aimed to investigate the impact of a cognitive training with minimal motor components on lower limb choice-reaction performance. A total of 44 healthy individuals (26.4 ± 3.7 years, 27 males) were randomly allocated to a cognitive training (CT) or an inactive control group (CON). The CT group participants, three times per week, engaged in a computerized exercise program targeting skills such as attention, reaction time, processing speed or inhibition control. Before and after the 6-week intervention period, lower limb choice-reaction time was assessed using the Quick Feet Board device. An ANCOVA of the post-intervention values, controlling for baseline data, demonstrated superior unilateral choice-reaction performance (stance on dominant leg) in the CT group (p = 0.04, r = 0.31). Conversely, no difference was found for the bilateral component of the test (p > .05). Off-court cognitive training may represent a suitable method to enhance reactive motor skills in athletes.",2020,"Conversely, no difference was found for the bilateral component of the test (p > .05).","['44 healthy individuals (26.4 ± 3.7 years, 27 males', 'athletes']","['cognitive training (CT) or an inactive control group (CON', 'cognitive training', 'Computerized Cognitive Training with Minimal Motor Component', 'cognitive training with minimal motor components', 'computerized exercise program targeting skills such as attention, reaction time, processing speed or inhibition control']","['lower limb choice-reaction performance', 'superior unilateral choice-reaction performance (stance on dominant leg', 'lower limb choice-reaction time', 'Lower Limb Choice-Reaction Time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",44.0,0.0285239,"Conversely, no difference was found for the bilateral component of the test (p > .05).","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wilke', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Vogel', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University, Frankfurt am Main, Germany.'}]",Journal of sports science & medicine,[]
3124,32875505,Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial.,"BACKGROUND


Clinical decision support (CDS) is a promising tool for reducing antibiotic prescribing for acute respiratory infections (ARIs).
OBJECTIVE


To assess the impact of previously effective CDS on antibiotic-prescribing rates for ARIs when adapted and implemented in diverse primary care settings.
DESIGN


Cluster randomized clinical trial (RCT) implementing a CDS tool designed to guide evidence-based evaluation and treatment of streptococcal pharyngitis and pneumonia.
SETTING


Two large academic health system primary care networks with a mix of providers.
PARTICIPANTS


All primary care practices within each health system were invited. All providers within participating clinic were considered a participant. Practices were randomized selection to a control or intervention group.
INTERVENTIONS


Intervention practice providers had access to an integrated clinical prediction rule (iCPR) system designed to determine the risk of bacterial infection from reason for visit of sore throat, cough, or upper respiratory infection and guide evidence-based evaluation and treatment.
MAIN OUTCOME(S)


Change in overall antibiotic prescription rates.
MEASURE(S)


Frequency, rates, and type of antibiotics prescribed in intervention and controls groups.
RESULTS


33 primary care practices participated with 541 providers and 100,573 patient visits. Intervention providers completed the tool in 6.9% of eligible visits. Antibiotics were prescribed in 35% and 36% of intervention and control visits, respectively, showing no statistically significant difference. There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
CONCLUSIONS


The iCPR tool was not effective in reducing antibiotic prescription rates for upper respiratory infections in diverse primary care settings. This has implications for the generalizability of CDS tools as they are adapted to heterogeneous clinical contexts.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT02534987). Registered August 26, 2015 at https://clinicaltrials.gov.",2020,"There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
","['All primary care practices within each health system were invited', '33 primary care practices participated with 541 providers and 100,573 patient visits', 'Acute Respiratory Infections', 'Two large academic health system primary care networks with a mix of providers']","['Intervention practice providers had access to an integrated clinical prediction rule (iCPR) system designed to determine the risk of bacterial infection from reason for visit of sore throat, cough, or upper respiratory infection and guide evidence-based evaluation and treatment']","['antibiotic prescription rates', 'overall antibiotic prescription rates', 'Antibiotics', 'rates of orders for rapid streptococcal tests']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179496', 'cui_str': 'Clinical Prediction Rule'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004623', 'cui_str': 'Bacterial infectious disease'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1868901', 'cui_str': 'Rapid streptococcal test'}]",,0.170395,"There were also no differences in rates of orders for rapid streptococcal tests (RR, 0.94; P = 0.11) or chest X-rays (RR, 1.01; P = 0.999) between groups.
","[{'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'New York University School of Medicine, New York, NY, USA. Devin.Mann@nyulangone.org.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'McGinn', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Safiya', 'Initials': 'S', 'LastName': 'Richardson', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Palmisano', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Sara Kuppin', 'Initials': 'SK', 'LastName': 'Chokshi', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Mishuris', 'Affiliation': 'Boston University, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'McCullagh', 'Affiliation': 'Hofstra Northwell School of Medicine, New York, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dinh-Le', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feldstein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06096-3']
3125,32881374,Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy for the treatment of mild-to-moderate endometriosis: randomised controlled trial.,,2020,,['mild-to-moderate endometriosis'],['Re: Laparoscopic ablation or excision with helium thermal coagulator versus electrodiathermy'],[],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0018880', 'cui_str': 'Helium'}]",[],,0.0688023,,"[{'ForeName': 'Shamma', 'Initials': 'S', 'LastName': 'Al-Inizi', 'Affiliation': 'Department of Obstetrics and Gynaecology, South Tyneside and Sunderland NHS Foundation Trust, South Shields, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16451']
3126,32877302,"Re: The Effect of Antioxidants on Male Factor Infertility: The Males, Antioxidants, and Infertility (MOXI) Randomized Clinical Trial.",,2020,,['Male Factor Infertility'],['Antioxidants'],"['Males, Antioxidants, and Infertility (MOXI']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]",,0.275223,,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Niederberger', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001253.01']
3127,32877509,The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study.,"OBJECTIVES


To assess the effects of P6 and LI4 acupressure on post-caesarean pain and analgesic consumption.
DESIGN


This was a randomized, single-blinded, placebo-controlled study conducted in a university-affiliated obstetrics clinic between July 2017 and July 2018.
PARTICIPANTS


Women (n = 132) were randomly assigned to acupressure (n = 44), placebo (n = 44) and control (n = 44) groups.
SETTING


All groups received routine nursing care and analgesia protocol for post-cesarean pain. Acupressure was performed in two sessions, the postpartum second and fourth hours, with the following protocol: bilaterally to P6 (point on wrist) and LI4 (point on hand) points (for 3 minutes on each point). In the placebo group, it was just touched without the pressure on acupressure points, but the main difference was that touching was too superficial to have a therapeutic effect. The control group received only routine nursing care and analgesia protocol for post-cesarean pain.
MAIN OUTCOME MEASURES


The post-caesarean pain was evaluated four times before and after each session using Visual Analog Scale for pain. Also, the analgesia protocol for post-cesarean pain was recorded for all women.
RESULTS


The acupressure group experienced the lowest level of post-cesarean pain compared with the placebo and control groups (P = 0.000). The consumption of pethidine hydrochloride and paracetamol was statistically lower in the acupressure group compared with the placebo and control groups (respectively, P = 0.002 and P = 0.040).
CONCLUSION


Acupressure is an effective method for reducing post-cesarean pain and analgesic consumption. Clinical trial registration: ClinicalTrials.gov: NCT04337801.",2020,"The consumption of pethidine hydrochloride and paracetamol was statistically lower in the acupressure group compared to the placebo and control groups (respectively p = 0.002 and p = 0.040).
","['a university-affiliated obstetrics clinic between July 2017 and July 2018', 'Women (n=132', 'n=44), and control (n=44) groups']","['Acupressure', 'pethidine hydrochloride and paracetamol', 'acupressure', 'placebo', 'routine nursing care and analgesia protocol', 'Placebo', 'P6 and LI4 acupressure']","['Post-Cesarean Pain and Analgesic Consumption', 'cesarean pain', 'post-cesarean pain and analgesic consumption', 'post-caesarean pain', 'lowest level of post-cesarean pain', 'Visual Analog Scale for pain']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0353148', 'cui_str': 'Meperidine hydrochloride'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0450480', 'cui_str': 'LI4'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.352136,"The consumption of pethidine hydrochloride and paracetamol was statistically lower in the acupressure group compared to the placebo and control groups (respectively p = 0.002 and p = 0.040).
","[{'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Akgün', 'Affiliation': 'Nursing Faculty, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'İlkay', 'Initials': 'İ', 'LastName': 'Boz', 'Affiliation': 'Nursing Faculty, Akdeniz University, Antalya, Turkey.'}]",International journal for quality in health care : journal of the International Society for Quality in Health Care,['10.1093/intqhc/mzaa107']
3128,32883018,Digital Training for Non-Specialist Health Workers to Deliver a Brief Psychological Treatment for Depression in Primary Care in India: Findings from a Randomized Pilot Study.,"Introduction : Task sharing holds promise for scaling up depression care in countries such as India, yet requires training large numbers of non-specialist health workers. This pilot trial evaluated the feasibility and acceptability of a digital program for training non-specialist health workers to deliver a brief psychological treatment for depression.  Methods : Participants were non-specialist health workers recruited from primary care facilities in Sehore, a rural district in Madhya Pradesh, India. A three-arm randomized controlled trial design was used, comparing digital training alone (DGT) to digital training with remote support (DGT+), and conventional face-to-face training. The primary outcome was the feasibility and acceptability of digital training programs. Preliminary effectiveness was explored as changes in competency outcomes, assessed using a self-reported measure covering the specific knowledge and skills required to deliver the brief psychological treatment for depression. Outcomes were collected at pre-training and post-training.  Results : Of 42 non-specialist health workers randomized to the training programs, 36 including 10 (72%) in face-to-face, 12 (86%) in DGT, and 14 (100%) in DGT+ arms started the training. Among these participants, 27 (64%) completed the training, with 8 (57%) in face-to-face, 8 (57%) in DGT, and 11 (79%) in DGT+. The addition of remote telephone support appeared to improve completion rates for DGT+ participants. The competency outcome improved across all groups, with no significant between-group differences. However, face-to-face and DGT+ participants showed greater improvement compared to DGT alone. There were numerous technical challenges with the digital training program such as poor connectivity, smartphone app not loading, and difficulty navigating the course content-issues that were further emphasized in follow-up focus group discussions with participants. Feedback and recommendations collected from participants informed further modifications and refinements to the training programs in preparation for a forthcoming large-scale effectiveness trial.  Conclusions : This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.",2020,This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.,"['Methods : Participants were non-specialist health workers recruited from primary care facilities in Sehore, a rural district in Madhya Pradesh, India', '42 non-specialist health workers randomized to the training programs, 36 including 10 (72%) in face-to-face, 12 (86%) in DGT, and 14 (100%) in DGT+ arms']","['digital program', 'Digital Training', 'digital training alone (DGT) to digital training with remote support (DGT+), and conventional face-to-face training']","['completion rates', 'feasibility and acceptability of digital training programs']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0363138,This study adds to mounting efforts aimed at leveraging digital technology to increase the availability of evidence-based mental health services in primary care settings in low-resource settings.,"[{'ForeName': 'Shital S', 'Initials': 'SS', 'LastName': 'Muke', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Tugnawat', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Udita', 'Initials': 'U', 'LastName': 'Joshi', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Azaz', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Shrivastava', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Restivo', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Bhan', 'Affiliation': 'Sangath, 120 Deepak Society, Chuna Bhatti, Kolar Road, Bhopal 462016, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Naslund', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176368']
3129,32885374,Implementation of a Behavioral Economics Electronic Health Record (BE-EHR) Module to Reduce Overtreatment of Diabetes in Older Adults.,"BACKGROUND


Intensive glycemic control is of unclear benefit and carries increased risk for older adults with diabetes. The American Geriatrics Society's (AGS) Choosing Wisely (CW) guideline promotes less aggressive glycemic targets and reduction in pharmacologic therapy for older adults with type II diabetes. Meanwhile, behavioral economic (BE) approaches offer promise in influencing hard-to-change behavior, and previous studies have shown the benefits of using electronic health record (EHR) technology to encourage guideline adherence.
OBJECTIVE


This study aimed to develop and pilot test an intervention that leverages BE with EHR technology to promote appropriate diabetes management in older adults.
DESIGN


A pilot study within the New York University Langone Health (NYULH) EHR and Epic system to deliver BE-inspired nudges at five NYULH clinics at varying time points from July 12, 2018, through October 31, 2019.
PARTICIPANTS


Clinicians across five practices in the NYULH system whose patients were older adults (age 76 and older) with type II diabetes.
INTERVENTIONS


A BE-EHR module comprising six nudges was developed through a series of design workshops, interviews, user-testing sessions, and clinic visits. BE principles utilized in the nudges include framing, social norming, accountable justification, defaults, affirmation, and gamification.
MAIN MEASURES


Patient-level CW compliance.
KEY RESULTS


CW compliance increased 5.1% from a 16-week interval at baseline to a 16-week interval post intervention. From February 14 to June 5, 2018 (prior to the first nudge launch in Vanguard clinics), CW compliance for 1278 patients was mean (95% CI)-16.1% (14.1%, 18.1%). From July 3 to October 22, 2019 (after BE-EHR module launch at all five clinics), CW compliance for 680 patients was 21.2% (18.1%, 24.3%).
CONCLUSIONS


The BE-EHR module shows promise for promoting the AGS CW guideline and improving diabetes management in older adults. A randomized controlled trial will commence to test the effectiveness of the intervention across 66 NYULH clinics.
NIH TRIAL REGISTRY NUMBER


NCT03409523.",2020,"KEY RESULTS


CW compliance increased 5.1% from a 16-week interval at baseline to a 16-week interval post intervention.","['older adults', 'older adults with type II diabetes', 'Older Adults', '66 NYULH clinics', 'older adults with diabetes', 'New York University Langone Health (NYULH', 'Clinicians across five practices in the NYULH system whose patients were older adults (age 76 and older) with type II diabetes']","['Behavioral Economics Electronic Health Record (BE-EHR) Module', 'EHR technology']",['CW compliance'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0501554,"KEY RESULTS


CW compliance increased 5.1% from a 16-week interval at baseline to a 16-week interval post intervention.","[{'ForeName': 'Hayley M', 'Initials': 'HM', 'LastName': 'Belli', 'Affiliation': 'Division of Biostatistics, Department of Population Health, New York University School of Medicine, New York, NY, USA. Hayley.Belli@nyulangone.org.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Chokshi', 'Affiliation': 'Division of Healthcare Delivery Science, Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Hegde', 'Affiliation': 'Fern Health, New York, NY, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Blecker', 'Affiliation': 'Division of Healthcare Delivery Science, Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Testa', 'Affiliation': 'Medical Center Information Technology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Judd', 'Initials': 'J', 'LastName': 'Anderman', 'Affiliation': 'Medical Center Information Technology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Medical Center Information Technology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Devin M', 'Initials': 'DM', 'LastName': 'Mann', 'Affiliation': 'Division of Healthcare Delivery Science, Department of Population Health, New York University School of Medicine, New York, NY, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06119-z']
3130,32888339,Nurse-led follow-up in survivorship care of gynaecological malignancies-A randomised controlled trial.,"OBJECTIVE


To assess clinical and psychosocial outcomes of nurse-led follow-up in survivorship care of gynaecological malignancies.
METHODS


Women with endometrial or ovarian cancer who were attending regular post-treatment follow-up at a tertiary referral centre were randomised into two groups-group-1: telephone follow-up by nurses and group-2: gynaecologists-led clinic follow-up. Women in group-1 were asked about their symptoms and quality of life (QoL) by nurses. Women in group-2 were followed up by gynaecologists and underwent symptom reviews and physical examinations. All ovarian cancer patients in both groups also had CA125 measured. All recruited women completed a QoL questionnaire (EORTC QLQ-C30), HADS-anxiety questionnaire and symptom checklist.
RESULTS


385 women (215 with endometrial and 170 with ovarian cancer) were randomised. There was no significant difference in the detection of recurrence according to the two follow-up protocols. However, women in the nurse-led arm scored higher on emotional (p = 0.023) and cognitive functioning (p = 0.012). Those in the gynaecologist-led arm scored higher on the HADS-anxiety scale (p = 0.001) and were more likely to report symptoms.
CONCLUSIONS


Our results demonstrate a preliminary non-inferiority of nurse-led follow-up, with improved psychological morbidity and QoL. Thus, nurse-led follow-up can be considered an effective substitute for hospital-based care.",2020,"However, women in the nurse-led arm scored higher on emotional (p = 0.023) and cognitive functioning (p = 0.012).","['Women with endometrial or ovarian cancer who were attending regular post-treatment follow-up at a tertiary referral centre', 'All ovarian cancer patients', '385 women (215 with endometrial and 170 with ovarian cancer']",['telephone follow-up by nurses and group-2: gynaecologists-led clinic follow-up'],"['QoL questionnaire (EORTC QLQ-C30), HADS-anxiety questionnaire and symptom checklist', 'HADS-anxiety scale', 'psychological morbidity and QoL', 'cognitive functioning', 'symptoms and quality of life (QoL', 'detection of recurrence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",385.0,0.1293,"However, women in the nurse-led arm scored higher on emotional (p = 0.023) and cognitive functioning (p = 0.012).","[{'ForeName': 'Siew-Fei', 'Initials': 'SF', 'LastName': 'Ngu', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Mandy M Y', 'Initials': 'MMY', 'LastName': 'Chu', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Ka Yu', 'Initials': 'KY', 'LastName': 'Tse', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Hextan Y S', 'Initials': 'HYS', 'LastName': 'Ngan', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}, {'ForeName': 'Karen K L', 'Initials': 'KKL', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong SAR.'}]",European journal of cancer care,['10.1111/ecc.13325']
3131,32886566,"Health Department Efforts to Increase Hepatitis C RNA Testing Among People Appearing Out of Care: Comparison of Outreach Approaches, New York City, 2017.","OBJECTIVES


Hepatitis C virus (HCV) infection is a serious health problem in New York City. Although curative treatments are available, many people are out of care. The New York City Department of Health and Mental Hygiene (DOHMH) used surveillance data and various outreach methods to attempt to link to care people diagnosed with HCV infection from 2010 through 2015.
METHODS


We randomly assigned people out of care (ie, no HCV test >6 months after first report) to 4 outreach groups: no outreach (control group); letter only; letter and telephone call; and letter, text message, and telephone call. Three months after outreach ended, we analyzed surveillance data to identify people with a subsequent HCV RNA or genotype test suggesting linkage to care.
RESULTS


Of 2626 selected people, 199 (7.6%) had a subsequent HCV test. People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]). People in the letter and telephone group had higher odds of a subsequent test than people in the letter-only group (aOR = 1.72; 95% CI, 1.04-2.74). Most people in the letter and telephone (136/200, 68.0%) and the letter, text, and telephone (71/99, 71.7%) groups could not be reached, primarily because telephone numbers were incorrect or out of service.
CONCLUSION


Reaching out to people soon after first report or prioritizing groups in which more recent contact information can be found might improve outcomes of future outreach.",2020,"People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]).","['Of 2626 selected people, 199 (7.6%) had a subsequent HCV test', 'care people diagnosed with HCV infection from 2010 through 2015', 'People Appearing Out of Care']","['care (ie, no HCV test >6 months after first report) to 4 outreach groups: no outreach (control group); letter only; letter and telephone call; and letter, text message, and telephone call']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2363789', 'cui_str': 'Hepatitis C virus test'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]","[{'cui': 'C2363789', 'cui_str': 'Hepatitis C virus test'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],2626.0,0.0827249,"People in all 3 outreach groups had higher odds of a subsequent test than people in the control group (letter only: adjusted odds ratio [aOR] = 1.81 [95% CI, 1.18-2.91]; letter and telephone: aOR = 3.11 [95% CI, 1.67-5.79]; letter, text, and telephone: aOR = 3.17 [95% CI, 1.48-6.51]).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Miranda S', 'Initials': 'MS', 'LastName': 'Moore', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bocour', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Nirah', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Winters', 'Affiliation': '364931 New York City Department of Health and Mental Hygiene, Bureau of Communicable Disease, Division of Disease Control, Viral Hepatitis Program, Queens, NY, USA.'}]","Public health reports (Washington, D.C. : 1974)",['10.1177/0033354920952068']
3132,32891418,"Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial.","PURPOSE


Dyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD.
METHODS


This multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150-500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDL-C and non-HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment.
FINDINGS


The difference in the mean percentage change in non-HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was -12.45% (95% CI, -17.18 to -7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy.
IMPLICATIONS


In these Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with pitavastatin/fenofibrate was associated with a greater reduction in non-HDL-C compared with that with pitavastatin monotherapy, and a significantly improvement in other lipid levels. Moreover, the combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. Therefore, pitavastatin/fenofibrate combination therapy could be effective and well tolerated in patients with mixed dyslipidemia. ClinicalTrials.gov identifier: NCT03618797.",2020,"Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively.","['347 eligible patients', 'Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with', 'patients with mixed dyslipidemia', 'Korean patients with a high risk for CVD and a controlled LDL-C level (<100\xa0mg/dL) and a TG level of 150-500\xa0mg/dL after a run-in period with', 'patients with controlled LDL-C and non-HDL-C (<130\xa0mg/dL) levels were included after the completion of the main study', 'High-risk Korean Patients with Mixed Dyslipidemia', 'patients with mixed dyslipidemia and a high risk for CVD']","['pitavastatin/fenofibrate', 'statin/fenofibrate combination therapy', 'Pitavastatin Versus Pitavastatin/Fenofibrate', 'pitavastatin 2\xa0mg with or without fenofibrate', 'pitavastatin monotherapy', 'pitavastatin 2\xa0mg alone', 'pitavastatin/fenofibrate combination therapy']","['lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein', 'effective and well tolerated', 'rates of achievement of non-HDL-C and apolipoprotein B targets', 'Efficacy and Tolerability', 'elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels', 'lipid levels', 'low-density lipoprotein cholesterol (LDL-C) level', 'CVD risk', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",347.0,0.0832424,"Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively.","[{'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Ihm', 'Affiliation': ""Department of Internal Medicine, Bucheon St. Mary's Hospital, Bucheon, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Woo-Baek', 'Initials': 'WB', 'LastName': 'Chung', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Uijeongbu St. Mary's Hospital, Uijeongbu, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Byung-Hee', 'Initials': 'BH', 'LastName': 'Hwang', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Ki-Dong', 'Initials': 'KD', 'LastName': 'Yoo', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, Suwon, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Her', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, Suwon, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Woo-Hyuk', 'Initials': 'WH', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Ansan Hospital, Korea University, Ansan, South Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Department of Internal Medicine, Bundang Hospital, College of Medicine, Seoul National University, Seongnam, South Korea.'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Dong-A University Hospital, Busan, South Korea.'}, {'ForeName': 'Ju-Han', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Department of Internal Medicine, National Health Insurance Service, Ilsan Hospital, Goyang, South Korea.'}, {'ForeName': 'Byung-Ryul', 'Initials': 'BR', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangwon National University Hospital, Kangwon National University, Chuncheon, South Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Cheju Halla General Hospital, Jeju, South Korea.'}, {'ForeName': 'Sang-Don', 'Initials': 'SD', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Jin-Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Jeong-Taek', 'Initials': 'JT', 'LastName': 'Woo', 'Affiliation': 'Department of Internal Medicine, Kyunghee University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Byung-Wan', 'Initials': 'BW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Kyung-Ah', 'Initials': 'KA', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, South Korea.'}, {'ForeName': 'Kyung-Heon', 'Initials': 'KH', 'LastName': 'Won', 'Affiliation': 'Department of Internal Medicine, Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Jae-Myung', 'Initials': 'JM', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea.'}, {'ForeName': 'Choon Hee', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, South Korea.'}, {'ForeName': 'Hae-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'Ho-Chan', 'Initials': 'HC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Dongsan Hospital, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Ki-Bae', 'Initials': 'KB', 'LastName': 'Seung', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea. Electronic address: kbseung0217@gmail.com.""}]",Clinical therapeutics,['10.1016/j.clinthera.2020.08.002']
3133,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
3134,32892320,Spirulina supplementation improves oxygen uptake in arm cycling exercise.,"PURPOSE


Spirulina has previously been reported to improve high-intensity exercise performance and hemoglobin. However, spirulina's effect on arm cycling exercise has yet to be investigated. The purpose of this study was to investigate the responses of spirulina supplementation on hemoglobin and on oxygen uptake, RER and HR during seated arm cycling exercise.
METHODS


In a double-blinded randomized crossover design, eleven males untrained in arm cycling ingested 6 g/day of spirulina or placebo for seven days. Seated on the Arm Crank Ergometer, each participant performed a baseline V̇O 2max  test, and then after supplementation, 2 × 30-min submaximal exercise bouts corresponding to 55% of their V̇O 2max , followed by an incremental test to fatigue. A seven-day wash-out period was required between conditions. Oxygen uptake, RER and HR were measured continuously during exercise and hemoglobin measured prior to exercise after both conditions.
RESULTS


Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9). After spirulina supplementation, during the 30-min exercise bouts, oxygen uptake and HR were significantly lower (2170 ml/min ± 173 Vs 2311 ml/min ± 189 and 154 bpm ± 14 Vs 149 bpm ± 17), RER was not significantly different. In comparison to placebo, Spirulina significantly increased oxygen uptake at time of fatigue (34.10 ml/min/kg ± 6.03 Vs 37.37 ml/min/kg ± 5.98). Time taken to fatigue was not different.
CONCLUSION


Spirulina supplementation significantly reduces oxygen uptake and HR during arm cycling submaximal exercise, allowing for an increased oxygen uptake during an incremental test to fatigue.",2020,"RESULTS


Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9).",['eleven males untrained in arm'],"['placebo', 'Placebo', 'cycling ingested 6\xa0g/day of spirulina or placebo', 'Spirulina supplementation']","['oxygen uptake and HR', 'Oxygen uptake, RER and HR', 'oxygen uptake', 'oxygen uptake at time of fatigue', 'Time taken to fatigue', 'RER', 'hemoglobin and on oxygen uptake, RER and HR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",11.0,0.401488,"RESULTS


Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9).","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Gurney', 'Affiliation': 'School of Life Sciences, Kingston University, London, KT1 2EE, UK. T.Gurney@kingston.ac.uk.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Spendiff', 'Affiliation': 'School of Life Sciences, Kingston University, London, KT1 2EE, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04487-2']
3135,32895571,Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial.,"We report on molecular analyses of baseline tumor samples from the phase 3 JAVELIN Renal 101 trial (n = 886; NCT02684006 ), which demonstrated significantly prolonged progression-free survival (PFS) with first-line avelumab + axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We found that neither expression of the commonly assessed biomarker programmed cell death ligand 1 (PD-L1) nor tumor mutational burden differentiated PFS in either study arm. Similarly, the presence of FcɣR single nucleotide polymorphisms was unimpactful. We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types. These findings provide insight into the determinants of response to combined PD-1/PD-L1 and angiogenic pathway inhibition and may aid in the development of strategies for improved patient care in aRCC.",2020,"We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types.","['advanced renal cell carcinoma', 'in advanced renal cell carcinoma (aRCC']","['Avelumab plus axitinib versus sunitinib', 'avelumab\u2009+\u2009axitinib versus sunitinib']",['prolonged progression-free survival (PFS'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0249677,"We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA. motzerr@mskcc.org.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Robbins', 'Affiliation': 'Translational Oncology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""Department of Genitourinary Oncology, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Haanen', 'Affiliation': 'Division of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Xinmeng Jasmine', 'Initials': 'XJ', 'LastName': 'Mu', 'Affiliation': 'Computational Biology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Ching', 'Affiliation': 'Computational Biology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Graduate School of Medicine, Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Deputy Director for Science, Moscow Scientific Research Oncology Institute, Moscow, Russian Federation.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Department of Medical Oncology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Campbell', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Penkov', 'Affiliation': 'Private Medical Institution, Euromedservice, St. Petersburg, Russian Federation.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Hariharan', 'Affiliation': 'Oncology, Pfizer, New York, NY, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Computational Biology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Chudnovsky', 'Affiliation': 'Oncology, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Immuno-Oncology, Pfizer, Milan, Italy.'}, {'ForeName': 'Amber C', 'Initials': 'AC', 'LastName': 'Donahue', 'Affiliation': 'Translational Oncology, Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Medical Oncology, The Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA, USA. toni_choueiri@dfci.harvard.edu.""}]",Nature medicine,['10.1038/s41591-020-1044-8']
3136,32929634,"Elderberry Extract Outpatient Influenza Treatment for Emergency Room Patients Ages 5 and Above: a Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Black elderberry, used medicinally for centuries, decreased influenza duration by 4 days in three previous peer-reviewed trials. US elderberry sales, possibly related to a ""high severity"" and ""high activity"" influenza season from January to March 2018, more than doubled from 2017 to 2018 to > $100 million.
OBJECTIVE


To determine whether elderberry extract decreases influenza's duration and severity.
DESIGN


FDA-approved, investigator-initiated, Investigational New Drug, double-blind, randomized, placebo-controlled trial. Conducted January 2018-April 2019 in three emergency rooms, two suburban and one urban, in the Midwestern Health System.
PATIENTS


Eighty-seven consecutive, consenting patients, over age four, with < 48 h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test.
INTERVENTION


Patients from age 5 to 12 years received placebo or 15 ml (5.7 g) elderberry extract orally twice a day for 5 days; those > 12 years received 15 ml 4 times a day for 5 days. Patients were permitted to choose to also receive the standard dosage of oseltamivir.
MEASUREMENTS


Primary: days until all symptoms were none or mild for 21.5 h. Secondary: days to complete symptom resolution for 24 h.
RESULTS


The 87 participants were randomized to receive placebo (n = 44) or elderberry (n = 43). The average age was 25 ± 20 years, and 56% were male. The average number of days to reach all symptoms none or mild for 21.5 h in the placebo group was 4.9 ± 2.8 days compared to 5.3 ± 3.6 in the elderberry group (p = 0.57). The average number of days to complete resolution was 8.7 ± 3.8 and 8.6 ± 3.9 in the placebo and elderberry group, respectively (p = 0.87).
LIMITATIONS


Small sample size, but powered > 0.90 to detect 2-day benefit of elderberry versus placebo.
CONCLUSIONS


We found no evidence that elderberry benefits the duration or severity of influenza. Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone. Our results contradict previous studies and demonstrate the need for further studies.
TRIAL REGISTRATION


NCT03410862.",2020,Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone.,"['Eighty-seven consecutive, consenting patients, over age four, with <\u200948\xa0h of at least 2 moderate-severity influenza symptoms and positive polymerase chain reaction influenza test', 'Conducted January 2018-April 2019 in three emergency rooms, two suburban and one urban, in the Midwestern Health System', '87 participants', 'The average age was 25\u2009±\u200920\xa0years, and 56% were male', 'Emergency Room Patients Ages 5 and Above']","['elderberry extract', 'elderberry taken alone (without oseltamivir', 'placebo', 'oseltamivir', 'Elderberry Extract Outpatient Influenza Treatment', 'Placebo']","['average number of days to reach all symptoms none or mild', 'average number of days to complete resolution']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1095913', 'cui_str': 'Elderberry preparation'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",87.0,0.579061,Post hoc analysis suggested primary outcomes with elderberry taken alone (without oseltamivir) were 2 days worse than with placebo taken alone.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Macknin', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA. macknim@ccf.org.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Wolski', 'Affiliation': 'C5 Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Negrey', 'Affiliation': 'Clinical Research Unit, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Mace', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06170-w']
3137,32930952,Effect of Genetic Polymorphisms on the Pharmacokinetics of Deferasirox in Healthy Chinese Subjects and an Artificial Neural Networks Model for Pharmacokinetic Prediction.,"BACKGROUND AND OBJECTIVE


Deferasirox is an oral iron chelator used to reduce iron levels in iron-overloaded patients with transfusion-dependent anemia or non-transfusion-dependent thalassemia. This study investigated the effects of genetic polymorphisms on the pharmacokinetics of deferasirox in healthy Chinese subjects and constructed a pharmacokinetic prediction model based on physiologic factors and genetic polymorphism data.
METHODS


Twenty-eight subjects were enrolled in a randomized, open-label, two-period crossover study, and they received a single dose of one of two formulations of deferasirox (20 mg/kg) with a 7-day washout interval between the two periods. The plasma defersirox concentration was determined using a validated liquid chromatography-tandem mass spectrometry method, and pharmacokinetic parameters were calculated using the noncompartmental method. The polymorphisms of uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1), UGT1A3, multidrug resistance protein 2 (MRP2), cytochrome P450 1A1 (CYP1A1), and breast cancer resistance protein 1 (BCRP1) were genotyped using Sanger sequencing. A back-propagation artificial neural network (BP-ANN) model was used to predict the pharmacokinetics.
RESULTS


The UGT1A1 rs887829 C > T single-nucleotide polymorphism (SNP) significantly influenced the area under the plasma concentration-time curve and the terminal half-life. Neither the MRP2 rs2273697 G > A SNP nor BCRP1 rs2231142 G > T SNP altered the absorption, disposition, and excretion of the drug. The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R 2  = 0.921).
CONCLUSION


Metabolic enzyme-related genetic polymorphisms were more strongly associated with the pharmacokinetics of deferasirox than membrane transporter-related genetic polymorphisms in the Chinese population.
TRIAL REGISTRATION


www.Chinadrugtrials.org.cn CTR20191164.",2020,"The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R 2  = 0.921).
","['Healthy Chinese Subjects and an Artificial Neural Networks Model for Pharmacokinetic Prediction', 'iron-overloaded patients with transfusion-dependent anemia or non-transfusion-dependent thalassemia', 'Twenty-eight subjects', 'healthy Chinese subjects']",['deferasirox'],"['absorption, disposition, and excretion of the drug', 'uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1), UGT1A3, multidrug resistance protein 2 (MRP2), cytochrome P450 1A1\xa0(CYP1A1), and breast cancer resistance protein 1 (BCRP1', 'plasma defersirox concentration']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3666003', 'cui_str': 'Transfusion dependent anaemia'}, {'cui': 'C3805143', 'cui_str': 'Non-transfusion dependent thalassaemia'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1619629', 'cui_str': 'deferasirox'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0763572', 'cui_str': 'P-glycoprotein 2'}, {'cui': 'C3252639', 'cui_str': 'CYP1A1 protein, human'}, {'cui': 'C0761993', 'cui_str': 'ABCG2 protein, human'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",28.0,0.0262401,"The BP-ANN model had a high goodness-of-fit index and good coherence between the predicted and measured concentrations (R 2  = 0.921).
","[{'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Lou', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China.'}, {'ForeName': 'Zourong', 'Initials': 'Z', 'LastName': 'Ruan', 'Affiliation': 'Center of Clinical Pharmacology, School of Medicine, The Second Affiliated Hospital of Zhejiang University, 88 Jiefang Road, Hangzhou, 310009, Zhejiang, China. zrlcyl@zju.edu.cn.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00647-z']
3138,32927858,Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial.,"Chronic neck pain is one of today's most prevalent pathologies. The International Classification of Diseases categorizes four subgroups based on patients' associated symptoms. However, this classification does not encompass upper cervical spine dysfunction. The aim is to compare the short- and mid-term effectiveness of adding a manual therapy approach to a cervical exercise protocol in patients with chronic neck pain and upper cervical spine dysfunction. Fifty-eight subjects with chronic neck pain and upper cervical spine dysfunction were recruited (29 = Manual therapy + Exercise; 29 = Exercise). Each group received four 20-min sessions, one per week during four consecutive weeks, and a home exercise regime. Upper flexion and flexion-rotation test range of motion, neck disability index, craniocervical flexion test, visual analogue scale, pressure pain threshold, global rating of change scale, and adherence to self-treatment were assessed at the beginning, end of the intervention and at 3- and 6-month follow-ups. The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group. Four 20-min sessions of Manual therapy + Exercise along with a home-exercise program is more effective in the short- to mid-term than an exercise protocol and a home-exercise program for patients with chronic neck pain and upper cervical dysfunction.",2020,The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group.,"['patients with chronic neck pain and upper cervical dysfunction', 'patients with chronic neck pain and upper cervical spine dysfunction', 'Patients with Chronic Neck Pain in Short- and Mid-Term', 'Fifty-eight subjects with chronic neck pain and upper cervical spine dysfunction were recruited (29 = Manual therapy + Exercise; 29 = Exercise']","['cervical exercise protocol', 'Cervical Exercise Program', 'exercise protocol and a home-exercise program', 'Manual therapy + Exercise', 'Manual therapy + Exercise along with a home-exercise program', 'manual therapy approach']","['Chronic neck pain', 'Upper flexion and flexion-rotation test range of motion, neck disability index, craniocervical flexion test, visual analogue scale, pressure pain threshold, global rating of change scale, and adherence to self-treatment', 'short- and medium-term']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",58.0,0.044157,The Manual therapy + Exercise group statistically improved short- and medium-term in all variables compared to the Exercise group.,"[{'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Malo-Urriés', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-de-Toro', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Sant Cugat del Vallès, Spain.'}, {'ForeName': 'María Orosia', 'Initials': 'MO', 'LastName': 'Lucha-López', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Tricás-Moreno', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Lorente', 'Affiliation': 'Impact Laboratory, Aragón Institute of Engineering Research (I3A), Universidad de Zaragoza, 50018 Zaragoza, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo-García', 'Affiliation': 'Faculty of Health Sciences, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186601']
3139,32932771,Effects of a Nine-Month Physical Activity Intervention on Morphological Characteristics and Motor and Cognitive Skills of Preschool Children.,"(1) Background: Regular physical activity (PA) plays an important role during early childhood physical and psychological development. This study investigates the effects of a 9-month PA intervention on physiological characteristics and motor and cognitive skills in preschool children. (2) Methods: Preschool children ( n  = 132; age 4 to 7 years) attending regular preschool programs were nonrandomly assigned to PA intervention ( n  = 66; 60 min sessions twice per week) or a control group ( n  = 66; no additional organized PA program) for 9 months. Exercise training for the intervention group included various sports games, outdoor activities, martial arts, yoga, and dance. Anthropometry, motor skills (7 tests), and cognitive skills (Raven's Colored Progressive Matrices and Cognitive Assessment System) were assessed before and after an intervention period in both groups. Data were analyzed using repeated-measures ANOVA. (3) Results: Body weight significantly increased in both groups over time. Compared to the changes observed in the control group, the intervention group significantly increased in chest circumference ( p  = 0.022). In contrast, the control group demonstrated an increase in waist circumference ( p  = 0.001), while these measures in the intervention group remained stable. Participants in the intervention group improved running speed ( p  = 0.016) and standing broad jump ( p  = 0.000). The flexibility level was maintained in the intervention group, while a significant decrease was observed in the control group ( p  = 0.010). Children from the intervention group demonstrated progress in the bent-arm hang test ( p  = 0.001), unlike the control group subjects. Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements. (4) Conclusions: Preschool children's participation in a preschool PA intervention improves their motor skills.",2020,"Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements.","['Preschool Children', ""Preschool children's"", 'preschool children', 'Preschool children ( n  = 132; age 4 to 7 years) attending regular preschool programs']","['Exercise training', 'Regular physical activity (PA', 'preschool PA intervention', 'Nine-Month Physical Activity Intervention', 'control group ( n  = 66; no additional organized PA program', 'PA intervention']","['chest circumference', 'flexibility level', 'motor skills', 'running speed', 'Morphological Characteristics and Motor and Cognitive Skills', 'waist circumference', 'physiological characteristics and motor and cognitive skills', 'cognitive skills', ""Anthropometry, motor skills (7 tests), and cognitive skills (Raven's Colored Progressive Matrices and Cognitive Assessment System"", 'Body weight']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1449597', 'cui_str': 'Corvus corax'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",132.0,0.0149852,"Varied improvements in cognitive skills were observed for different variables in both intervention and control groups, with no robust evidence for PA-intervention-related improvements.","[{'ForeName': 'Damjan', 'Initials': 'D', 'LastName': 'Jaksic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mandic', 'Affiliation': 'Active Living Laboratory, School for Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin 9016, New Zealand.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Maksimovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Milosevic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Roklicer', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Jovan', 'Initials': 'J', 'LastName': 'Vukovic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Suncica', 'Initials': 'S', 'LastName': 'Pocek', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Lakicevic', 'Affiliation': 'PhD Program in Health Promotion and Cognitive Sciences, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Sport and Exercise Science Research Unit, University of Palermo, 90100 Palermo, Italy.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cassar', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong 3216, Australia.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Drid', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186609']
3140,32933919,Machine learning predicts stem cell transplant response in severe scleroderma.,"OBJECTIVE


The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial demonstrated clinical benefit of haematopoietic stem cell transplant (HSCT) compared with cyclophosphamide (CYC). We mapped PBC (peripheral blood cell) samples from the SCOT clinical trial to scleroderma intrinsic subsets and tested the hypothesis that they predict long-term response to HSCT.
METHODS


We analysed gene expression from PBCs of SCOT participants to identify differential treatment response. PBC gene expression data were generated from 63 SCOT participants at baseline and follow-up timepoints. Participants who completed treatment protocol were stratified by intrinsic gene expression subsets at baseline, evaluated for event-free survival (EFS) and analysed for differentially expressed genes (DEGs).
RESULTS


Participants from the fibroproliferative subset on HSCT experienced significant improvement in EFS compared with fibroproliferative participants on CYC (p=0.0091). In contrast, EFS did not significantly differ between CYC and HSCT arms for the participants from the normal-like subset (p=0.77) or the inflammatory subset (p=0.1). At each timepoint, we observed considerably more DEGs in HSCT arm compared with CYC arm with HSCT arm showing significant changes in immune response pathways.
CONCLUSIONS


Participants from the fibroproliferative subset showed the most significant long-term benefit from HSCT compared with CYC. This study suggests that intrinsic subset stratification of patients may be used to identify patients with SSc who receive significant benefit from HSCT.",2020,"At each timepoint, we observed considerably more DEGs in HSCT arm compared with CYC arm with HSCT arm showing significant changes in immune response pathways.
",['severe scleroderma'],"['haematopoietic stem cell transplant (HSCT', 'Cyclophosphamide or Transplantation (SCOT', 'HSCT', 'Machine learning', 'cyclophosphamide (CYC']","['PBC gene expression data', 'immune response pathways', 'EFS']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}]","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",63.0,0.143652,"At each timepoint, we observed considerably more DEGs in HSCT arm compared with CYC arm with HSCT arm showing significant changes in immune response pathways.
","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Franks', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Martyanov', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Tammara A', 'Initials': 'TA', 'LastName': 'Wood', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Pinckney', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, Division of Rheumatology, University of California at Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'NIAID/NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Maureen D', 'Initials': 'MD', 'LastName': 'Mayes', 'Affiliation': 'Rheumatology and Clinical Immunogenetics, The University of Texas Health Science Center Houston Medical School, Houston, Texas, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McSweeney', 'Affiliation': 'Rocky Mountain Blood and Marrow Transplant Program, Colorado Blood Cancer Institute, Denver, Colorado, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Nash', 'Affiliation': 'Rocky Mountain Blood and Marrow Transplant Program, Colorado Blood Cancer Institute, Denver, Colorado, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Whitfield', 'Affiliation': 'Molecular and Systems Biology, Dartmouth College Geisel School of Medicine, Hanover, New Hampshire, USA michael.l.whitfield@dartmouth.edu.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217033']
3141,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
3142,32901072,"Standardized massage interventions as protocols for the induction of psychophysiological relaxation in the laboratory: a block randomized, controlled trial.","Health and disease are strongly linked to psychophysiological states. While stress research strongly benefits from standardized stressors, no established protocol focuses on the induction of psychophysiological relaxation. To maintain health, functioning regenerative systems are however likely as important as functioning stress systems. Thus, the identification of validated relaxation paradigms is needed. Here, we investigated whether standardized massages are capable of reliably inducing physiological and psychological states of relaxation. Relaxation was indicated by changes in high frequency heart rate variability (HF-HRV), a vagally-mediated heart rate variability component, and repeated ratings of subjective relaxation, and stress levels. Sixty healthy women were randomly assigned to a vagus nerve massage (n = 19), a soft shoulder massage (n = 22), or a resting control group (n = 19). During the intervention, HF-HRV and subjective relaxation increased, while subjective stress decreased significantly in all groups. Both massage interventions elicited significantly higher HF-HRV compared to the control group. Accordingly, both massage protocols increased psychophysiological relaxation, and may serve as useful tools in future research. However, future work will have to determine which of several protocols might be used as a gold standard to induce a psychophysiological state of relaxation in the laboratory.",2020,"During the intervention, HF-HRV and subjective relaxation increased, while subjective stress decreased significantly in all groups.",['Sixty healthy women'],"['soft shoulder massage', 'Standardized massage interventions', 'vagus nerve massage']","['HF-HRV and subjective relaxation', 'subjective stress', 'psychophysiological relaxation', 'HF-HRV', 'high frequency heart rate variability (HF-HRV), a vagally-mediated heart rate variability component, and repeated ratings of subjective relaxation, and stress levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042276', 'cui_str': 'Vagus nerve structure'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",60.0,0.0207587,"During the intervention, HF-HRV and subjective relaxation increased, while subjective stress decreased significantly in all groups.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany. maria.meier@uni.kn.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Unternaehrer', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Dimitroff', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Annika B E', 'Initials': 'ABE', 'LastName': 'Benz', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Ulrike U', 'Initials': 'UU', 'LastName': 'Bentele', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Sabine M', 'Initials': 'SM', 'LastName': 'Schorpp', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}]",Scientific reports,['10.1038/s41598-020-71173-w']
3143,32906842,Development and Evaluation of an Antiviral Agent Medication Adherence Education Program for Patients with Chronic Hepatitis C.,"This study aimed to develop and evaluate a goal attainment theory-based antiviral agent medication adherence education program (AMAEP) for patients with chronic hepatitis C. A nonequivalent control group pretest-posttest design was used. Data were collected from December 2019 to March 2020 from a control group of 35 outpatients and an experimental group of 28 outpatients older than 20 years old who had been diagnosed with chronic hepatitis C. The data analysis included an independent  t -test, a χ 2 -test or Fisher's exact test, a Kolmogorov-Smirnov test, an analysis of covariance, and a Mann-Whitney U test. The results showed the effectiveness of the education program for patients with chronic hepatitis C. There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001). Therefore, we hope that the education program developed in this study will be utilized as an intervention for patients with chronic hepatitis C and be further developed for other patients with viral hepatitis.",2020,"There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001).","['Data were collected from December 2019 to March 2020 from a control group of 35 outpatients and an experimental group of 28 outpatients older than 20 years old who had been diagnosed with chronic hepatitis C', 'Patients with Chronic Hepatitis C', 'patients with chronic hepatitis C and be further developed for other patients with viral hepatitis', 'patients with chronic hepatitis C']","['Antiviral Agent Medication Adherence Education Program', 'goal attainment theory-based antiviral agent medication adherence education program (AMAEP']","['medication adherence rate', 'medication misuse behavior', 'medication self-efficacy', 'knowledge of chronic hepatitis C']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}]",28.0,0.028512,"There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001).","[{'ForeName': 'Hoo Jeung', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan 48513, Korea.'}, {'ForeName': 'Euna', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan 48513, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186518']
3144,32907352,Effects of Short-Term Inhalation of Patchouli Oil on Professional Quality of Life and Stress Levels in Emergency Nurses: A Randomized Controlled Trial.,"Objectives:  The aim of this study was to investigate the effects of patchouli ( Pogostemon cablin  Benth.) inhalation by emergency nurses on their stress, compassion satisfaction, compassion fatigue, burnout, blood pressure, and heart rate.  Design:  A randomized controlled trial.  Setting/location:  University hospital in Incheon.  Subjects:  This study was performed from May to August 2018 after all subjects provided written informed consent. Fifty eligible emergency nurses were recruited and randomly allocated to inhale 5% patchouli oil in sweet almond oil (patchouli group,  n  = 25) or pure sweet almond oil (control group,  n  = 25).  Interventions:  Nurses in the patchouli group first inhaled patchouli oil at about 10 pm (the end of an afternoon shift) and inhaled patchouli oil a second time at about 10 pm on next day (24-h interval). Nurses in the control group inhaled pure sweet almond oil following the same schedule.  Outcome measures:  Outcome measured included blood pressure, heart rate, levels of stress, compassion satisfaction, compassion fatigue, and burnout.  Results:  Although there were no significant differences in blood pressure, heart rate, compassion fatigue, and burnout, levels of stress were significantly lower (0.06 ± 0.48 vs. 1.19 ± 1.19,  p  < 0.001) and compassion satisfaction significantly higher (0.56 ± 2.50 vs. -2.84 ± 2.43,  p  < 0.001) in the patchouli than in the control group. In addition, relative to baseline, compassion fatigue was significantly lower in the patchouli group (26.72 ± 4.98 vs. 25.88 ± 4.63,  p  = 0.016).  Conclusions:  Inhalation of patchouli oil effectively reduced the levels of stress and increased compassion satisfaction in emergency nurses, suggesting that patchouli oil inhalation may improve the professional quality of life of emergency nurses. ClinicalTrials.gov ID: KCT0004615.",2020,"Although there were no significant differences in blood pressure, heart rate, compassion fatigue, and burnout, levels of stress were significantly lower (0.06 ± 0.48 vs. 1.19 ± 1.19,  ","['August 2018 after all subjects provided written informed consent', 'Emergency Nurses', 'Fifty eligible emergency nurses', 'emergency nurses', 'Subjects']","['patchouli group first inhaled patchouli oil at about 10 pm (the end of an afternoon shift) and inhaled patchouli oil', 'inhale 5% patchouli oil in sweet almond oil (patchouli group,  n \u2009=\u200925) or pure sweet almond oil (control group,  n \u2009=\u200925', 'patchouli oil', 'Patchouli Oil', 'patchouli ( Pogostemon cablin  Benth', 'control group inhaled pure sweet almond oil']","['compassion satisfaction', 'stress, compassion satisfaction, compassion fatigue, burnout, blood pressure, and heart rate', 'levels of stress and increased compassion satisfaction', 'compassion fatigue', 'blood pressure, heart rate, compassion fatigue, and burnout, levels of stress', 'blood pressure, heart rate, levels of stress, compassion satisfaction, compassion fatigue, and burnout', 'professional quality of life of emergency nurses', 'Professional Quality of Life and Stress Levels']","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C1002062', 'cui_str': 'Patchouli'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0304147', 'cui_str': 'Oil of patchouli'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",,0.139381,"Although there were no significant differences in blood pressure, heart rate, compassion fatigue, and burnout, levels of stress were significantly lower (0.06 ± 0.48 vs. 1.19 ± 1.19,  ","[{'ForeName': 'You Kyoung', 'Initials': 'YK', 'LastName': 'Shin', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'KT&G Central Research Institute, Daejeon, Republic of Korea.'}, {'ForeName': 'Purum', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Geun Hee', 'Initials': 'GH', 'LastName': 'Seol', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0206']
3145,32907603,A qualitative assessment of factors influencing implementation and sustainability of evidence-based tobacco use treatment in Vietnam health centers.,"BACKGROUND


Effective strategies are needed to increase implementation and sustainability of evidence-based tobacco dependence treatment (TDT) in public health systems in low- and middle-income countries (LMICs). Our two-arm cluster randomized controlled trial (VQuit) found that a multicomponent implementation strategy was effective in increasing provider adherence to TDT guidelines in commune health center (CHCs) in Vietnam. In this paper, we present findings from a post-implementation qualitative assessment of factors influencing effective implementation and program sustainability.
METHODS


We conducted semi-structured qualitative interviews (n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites. Interviews were transcribed and translated into English. Two qualitative researchers used both deductive (guided by the Consolidated Framework for Implementation Research) and inductive approaches to analysis.
RESULTS


Facilitators of effective implementing of TDT included training and point-of-service tools (e.g., desktop chart with prompts for offering brief counseling) that increased knowledge and self-efficacy, patient demand for TDT, and a referral system, available in arm 2, which reduced the provider burden by shifting more intensive cessation counseling to a trained VHW. The primary challenges to sustainability were competing priorities that are driven by the Ministry of Health and may result in fewer resources for TDT compared with other health programs. However, providers and VHWs suggested several options for adapting the intervention and implementation strategies to address challenges and increasing engagement of local government committees and other sectors to sustain gains.
CONCLUSION


Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT. In addition, the results illustrate the dynamic interplay between barriers and facilitators for sustaining TDT at the policy and community/practice level, particularly in the context of centralized public health systems like Vietnam's. Sustaining gains in practice improvement and clinical outcomes will require strategies that include ongoing engagement with policymakers and other stakeholders at the national and local level, and planning for adaptations and subsequent resource allocations in order to meet the World Health Organization's goals promoting access to effective treatment for all tobacco users.
TRIAL REGISTRATION


NCT02564653 , registered September 2015.",2020,Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT.,"['commune health center (CHCs) in Vietnam', 'n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites', 'Vietnam health centers']",['semi-structured qualitative interviews'],"['knowledge and self-efficacy, patient demand for TDT']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0025081', 'cui_str': 'Medical Directors'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040332', 'cui_str': 'Tobacco dependence syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",52.0,0.0538565,Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT.,"[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'VanDevanter', 'Affiliation': 'Rory Myers College of Nursing, New York University, 433 First Avenue, New York, NY, 10010, USA.'}, {'ForeName': 'Milkie', 'Initials': 'M', 'LastName': 'Vu', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave., 17th floor, New York, NY, 10016, USA.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, 810 CT1A ĐN1, Ham Nghi Street, My Dinh 2 Ward, South Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Van Minh', 'Affiliation': 'Hanoi University of Public Health, No 1A Duc Thang Street, Duc Thang Ward, North Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Nam Truong', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, 810 CT1A ĐN1, Ham Nghi Street, My Dinh 2 Ward, South Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': 'Department of Public Health Policy and Management, School of Global Public Health, New York University, 715 Broadway, New York, NY, 10012, USA. ds186@nyu.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01035-6']
3146,32909059,"Effects of acute aerobic, resistance and combined exercises on 24-h glucose variability and skeletal muscle signalling responses in type 1 diabetics.","PURPOSE


To compare the effect of high-intensity aerobic (AER), resistance (RES), and combined (COMB: RES + AER) exercise, on interstitial glucose (IG) variability and skeletal muscle signalling pathways in type 1 diabetes (T1D).
METHODS


T1D participants (6 M/6F) wore a flash glucose monitoring system in four randomized sessions: one control (CONT), and one AER, RES and COMB (40 min each). Mean amplitude of glycemic excursions (MAGE), standard deviation (SD) and coefficient variation (CV) of IG were used to compare the 24 h post-exercise IG variability. Blood and muscle samples were collected to compare exercise-induced systemic and muscle signalling responses related to metabolic, growth and inflammatory adaptations.
RESULTS


Both RES and COMB decreased the 24 h MAGE compared to CONT; additionally, COMB decreased the 24 h SD and CV. In the 6-12 h post-exercise, all exercise modalities reduced the IG CV while SD decreased only after COMB. Both AER and COMB stimulated the PGC-1α mRNA expression and promoted the splicing of IGF-1Ea variant, while Akt and p38MAPK phosphorylation increased only after RES and COMB. Additionally, COMB enhanced eEF2 activation and RES increased myogenin and MRF4 mRNA expression. Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs increased after all exercise sessions, while serum CK and LDH level did not change.
CONCLUSION


COMB is more effective in reducing IG fluctuations compared to single-mode AER or RES exercise. Moreover, COMB simultaneously activates muscle signalling pathways involved in substrate metabolism and anabolic adaptations, which can help to improve glycaemic control and maintain muscle health in T1D.",2020,"Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs increased after all exercise sessions, while serum CK and LDH level did not change.
","['T1D participants (6\xa0M/6F) wore a', 'type 1 diabetes (T1D', 'type 1 diabetics']","['flash glucose monitoring system in four randomized sessions: one control (CONT), and one AER, RES and COMB', 'acute aerobic, resistance and combined exercises', 'high-intensity aerobic (AER), resistance (RES), and combined (COMB: RES\u2009+\u2009AER) exercise']","['serum CK and LDH level', 'splicing of IGF-1Ea variant, while Akt and p38MAPK phosphorylation', 'COMB', '24-h glucose variability and skeletal muscle signalling responses', 'Mean amplitude of glycemic excursions (MAGE), standard deviation (SD) and coefficient variation (CV) of IG', 'IG fluctuations', 'Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs', 'COMB enhanced eEF2 activation and RES increased myogenin and MRF4 mRNA expression']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035687', 'cui_str': 'RNA splicing'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0067053', 'cui_str': 'Myogenin'}, {'cui': 'C0083504', 'cui_str': 'myogenic factor 6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0321494,"Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs increased after all exercise sessions, while serum CK and LDH level did not change.
","[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Minnock', 'Affiliation': 'Institute for Sport and Health, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland. dean.minnock@ucdconnect.ie.'}, {'ForeName': 'Giosuè', 'Initials': 'G', 'LastName': 'Annibalini', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'Le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Contarelli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Laboratory of Inflammation, Metabolism, and Exercise Research (LAPIMEX) and Laboratory of Cellular Physiology, Department of Physiology, Institute of Basic Health Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Saltarelli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Valli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Vilberto', 'Initials': 'V', 'LastName': 'Stocchi', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Vito', 'Affiliation': 'Institute for Sport and Health, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland.'}]",European journal of applied physiology,['10.1007/s00421-020-04491-6']
3147,32911037,Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.,"AIMS


This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia.
METHODS


Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14 ± 2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake.
RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p < 0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r = -0.61 and r = -0.66, respectively; both p < 0.05).
CONCLUSIONS


Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.",2020,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","['patients with type 2 diabetes in 14 weeks', 'Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks', 'patients with type 2 diabetes and insomnia', 'patients with type 2 diabetes']",['suvorexant'],"['sleep quality and obesity-associated parameters', 'glycemic control', 'sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake', 'HbA1c and body weight', 'change HbA1c, CGM parameters, or body weight', 'Chronotherapeutic efficacy', 'sleep quality and metabolic parameters', 'subjective sleep parameters and metabolic parameters', 'sleep quality', 'sSE, abdominal circumference, and sucrose intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake'}]",13.0,0.026373,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","[{'ForeName': 'Fukumi', 'Initials': 'F', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Fumika', 'Initials': 'F', 'LastName': 'Shigiyama', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uchino', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kumashiro', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan. Electronic address: naoki.kumashiro@med.toho-u.ac.jp.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108412']
3148,32912051,A Pilot Randomized Controlled Trial Using SystemCHANGE™ Approach to Increase Physical Activity in Older Kidney Transplant Recipients.,"BACKGROUND


Cardiovascular disease is the leading cause of death in kidney transplant recipients. Physical activity after transplant is the most modifiable nonpharmacological factor for improving cardiovascular outcomes. Few studies have tested walking interventions to enhance daily steps and health outcomes in older kidney recipients.
METHODS


Using a pilot feasibility randomized clinical trial design, we tested the feasibility and efficacy of a 6-month SystemCHANGE™ (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention for recruitment, retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function). The SystemCHANGE™ + Activity Tracker intervention taught participants to use a multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker to achieve daily step goals.
RESULTS


Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group. The study protocol was feasible to deliver with high adherence to the protocol in both groups. The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283,  P  = .03) compared to the control group. The secondary outcome of heart rate decreased for the intervention group (baseline [mean] 74.4+ 10.8 [standard deviation, SD;] vs 6 months [mean] 67.6+ 11.3 [SD];  P  = .002) compared to the control group (baseline [mean] 70.67+ 10.4 [SD]; vs 6 months [mean] 70.2 + 11.1 [SD];  P  = .83).
CONCLUSIONS


SystemCHANGE™ + Activity Tracker intervention appears to be feasible and efficacious for increasing daily steps in older kidney recipients.",2020,"The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283,  P  = .03) compared to the control group.","['Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group', 'Older Kidney Transplant Recipients', 'kidney transplant recipients', 'older kidney recipients']","['SystemCHANGE + Activity Tracker intervention', 'multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker', '6-month SystemCHANGE (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention']","['retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function', 'daily steps', 'feasibility and efficacy', 'Physical Activity', 'Physical activity', 'heart rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0584483,"The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283,  P  = .03) compared to the control group.","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': '2647The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Russell', 'Affiliation': 'School of Nursing and Health Studies, 12273University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': '2647The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Mion', 'Affiliation': '2647The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': '2647The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Focht', 'Affiliation': '15953The Ohio State University College of Education and Human Ecology, Columbus, OH, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Daloul', 'Affiliation': '15953The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hathaway', 'Affiliation': '16165University of Tennessee Health Science Center College of Nursing Memphis, TN, USA.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.1177/1526924820958148']
3149,32912727,Taking the Leap Toward Cost-Conscious Education in Obstetrics and Gynaecology: A Preliminary Randomized Controlled Trial.,"OBJECTIVE


Residents have a professional obligation with respect to the stewardship of health care resources, yet there is a paucity of research on how to improve residents' cost-awareness. Rising health care expenditures highlight a critical need to improve education related to this competency. This study aimed to test if an educational module can teach residents to make cost-conscious decisions and reduce health care spending.
METHODS


All Canadian obstetrics and gynaecology residents in 2017 were eligible to participate in this randomized controlled trial. The study was administered online via REDCap. Interested residents were enrolled, stratified by level of training, and block randomized. Residents completed a survey to determine their management of 4 obstetrical scenarios. The intervention group reviewed an educational module on cost-effective ordering prior to completing the survey; the control group was given the option to review the module afterward. The primary outcome was mean total expenditures, compared between the 2 groups using the t test.
RESULTS


Eighty-five residents were enrolled between August and November 2017, and 63 residents from 13 Canadian residency programs completed the study requirements (33 control and 30 intervention). Mean total expenditure was CAD$291.03 (95% CI 259.38-322.68) versus CAD$192.98 (95% CI 170.67-215.29) for the control and intervention groups, respectively. These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001).
CONCLUSION


This educational module decreased expenditures by Canadian obstetrics and gynaecology residents managing hypothetical obstetrical cases. This introduces a potential curriculum innovation to improve resident education in judicious use of health care resources.",2020,"These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001).
","['Obstetrics and Gynaecology', 'Eighty-five residents were enrolled between August and November 2017, and 63 residents from 13 Canadian residency programs completed the study requirements (33 control and 30 intervention', 'Canadian obstetrics and gynaecology residents managing hypothetical obstetrical cases', 'All Canadian obstetrics and gynaecology residents in 2017 were eligible to participate']",['educational module'],"['total expenditures', 'Mean total expenditure', 'mean total expenditures']","[{'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",85.0,0.0785197,"These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001).
","[{'ForeName': 'Allison Diane', 'Initials': 'AD', 'LastName': 'Edwards', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alberta, Edmonton, AB. Electronic address: allison.edwards@ualberta.ca.'}, {'ForeName': 'Fahrin', 'Initials': 'F', 'LastName': 'Rawji', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alberta, Edmonton, AB.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, AB.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Ross', 'Affiliation': 'Department of Obstetrics and Gynecology, Lois Hole Hospital for Women, University of Alberta, Edmonton, AB.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.04.017']
3150,32913018,"Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study.","OBJECTIVE


To assess the long-term safety, tolerability, and efficacy of fremanezumab, a fully humanized monoclonal antibody approved for the preventive treatment of migraine.
METHODS


A 52-week, multicenter, randomized, double-blind, parallel-group study evaluated fremanezumab monthly or quarterly in adults with chronic migraine (CM) or episodic migraine (EM). Safety and tolerability were assessed by adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments (immediately and 1 hour after injection), laboratory/vitals assessments, and immunogenicity testing. Prespecified exploratory evaluations included change from baseline in the monthly number of migraine days, headache days of at least moderate severity, and days with any acute headache medication use. Change from baseline in headache-related disability (6-item Headache Impact Test scores) was also measured.
RESULTS


Of 1,890 patients enrolled, 551 and 559 patients with CM received quarterly and monthly dosing; 394 and 386 patients with EM received quarterly or monthly, respectively. The most commonly reported AEs were injection-site reactions (induration 33%, pain 31%, and erythema 26%). Fremanezumab reduced monthly migraine days (CM quarterly -7.2 days, CM monthly -8.0 days, EM quarterly -5.2 days, EM monthly -5.1 days) and headache days of at least moderate severity (CM quarterly -6.4 days, CM monthly -6.8 days, EM quarterly -4.4, EM monthly -4.2 days) from baseline to 12 months. Reductions in any acute headache medication use and headache-related disability were also maintained over 12 months.
CONCLUSIONS


Fremanezumab quarterly and fremanezumab monthly were well tolerated and demonstrated sustained improvements in monthly migraine days, headache days, and headache-related disability for up to 12 months in patients with migraine.
CLINICALTRIALSGOV


NCT02638103.
CLASSIFICATION OF EVIDENCE


This study provides Class IV evidence that long-term fremanezumab treatment is safe, well tolerated, and effective at sustaining reductions in monthly migraine and headache days.",2020,"Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months.","['adults with chronic migraine (CM) or episodic migraine (EM', '1890 patients enrolled']","['Fremanezumab', 'fremanezumab']","['Safety and tolerability', 'laboratory/vitals assessments, and immunogenicity testing', 'monthly number of: migraine days, headache days of at least moderate severity, and days with any acute headache medication use, respectively', 'monthly migraine days, headache days, and headache-related disability', 'acute headache medication use and headache-related disability', 'headache-related disability (HIT-6 scores', 'headache days of at least moderate severity', 'adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}]",1890.0,0.16836,"Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ. peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': ""From NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), SLaM Biomedical Research Centre, King's College London, UK; Jefferson Headache Center (S.D.S.), Thomas Jefferson University, Philadelphia; Teva Pharmaceutical Industries Ltd. (P.P.Y., J.M.C., X.N., R.Y.), Frazer, PA; and Mayo Clinic (D.W.D.), Phoenix, AZ.""}]",Neurology,['10.1212/WNL.0000000000010600']
3151,32913021,Effect of escitalopram dose and treatment duration on CSF Aβ levels in healthy older adults: A controlled clinical trial.,"OBJECTIVE


To determine whether treatment with escitalopram compared with placebo would lower CSF β-amyloid 42 (Aβ 42 ) levels.
RATIONALE


Serotonin signaling suppresses Aβ 42  in animal models of Alzheimer disease (AD) and young healthy humans. In a prospective study in older adults, we examined dose and treatment duration effects of escitalopram.
METHODS


Using lumbar punctures to sample CSF levels before and after a course of escitalopram treatment, cognitively normal older adults (n = 114) were assigned to placebo, 20 mg escitalopram × 2 weeks, 20 mg escitalopram × 8 weeks, or 30 mg escitalopram × 8 weeks; CSF sampled pretreatment and posttreatment and within-subject percent change in Aβ 42  was used as the primary outcome in subsequent analyses.
RESULTS


An overall 9.4% greater reduction in CSF Aβ 42  was found in escitalopram-treated compared with placebo-treated groups ( p  < 0.001, 95% confidence interval [CI] 4.9%-14.2%,  d  = 0.81). Positive baseline Aβ status (CSF Aβ 42  levels <250 pg/mL) was associated with smaller Aβ 42  reduction ( p  = 0.006, 95% CI -16.7% to 0.5%,  d  = -0.52) compared with negative baseline amyloid status (CSF Aβ 42  levels >250 pg/mL).
CONCLUSIONS


Short-term longitudinal doses of escitalopram decreased CSF Aβ 42  in cognitively normal older adults, the target group for AD prevention.
CLINICALTRIALSGOV IDENTIFIER


NCT02161458.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for cognitively normal older adults, escitalopram decreases CSF Aβ 42 .",2020,An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81).,"['older adults', 'healthy older adults', 'cognitively normal older adults (n = 114', ""42  in animal models of Alzheimer's disease (AD) and young healthy humans"", 'cognitively normal older adults, ESC decreases CSF Aβ 42 ', 'cognitively normal older adults']","['ESC treatment', 'ESC', 'placebo, treatment with escitalopram (ESC', 'placebo; 20 mg ESC', 'escitalopram', 'placebo']","['Positive baseline amyloid-beta status ', 'CSF (CSF) amyloid beta 42 (Aβ 42 ) levels', 'CSF Aβ levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0012644', 'cui_str': 'Animal Disease Models'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",114.0,0.0976057,An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81).,"[{'ForeName': 'Yvette I', 'Initials': 'YI', 'LastName': 'Sheline', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York. sheline@pennmedicine.upenn.edu.'}, {'ForeName': 'B Joy', 'Initials': 'BJ', 'LastName': 'Snider', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Beer', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Darsol', 'Initials': 'D', 'LastName': 'Seok', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Jin-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Waligorska', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korecka', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Aselcioglu', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Morris', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Shaw', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cirrito', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}]",Neurology,['10.1212/WNL.0000000000010725']
3152,32913029,Association of systemic secondary brain insults and outcome in patients with convulsive status epilepticus: A post hoc study of a randomized controlled trial.,"OBJECTIVE


To evaluate the association between systemic factors (mean arterial blood pressure, arterial partial pressures of carbon dioxide and oxygen, body temperature, natremia, and glycemia) on day 1 and neurologic outcomes 90 days after convulsive status epilepticus.
METHODS


This was a post hoc analysis of the Evaluation of Therapeutic Hypothermia in Convulsive Status Epilepticus in Adults in Intensive Care (HYBERNATUS) multicenter open-label controlled trial, which randomized 270 critically ill patients with convulsive status epilepticus requiring mechanical ventilation to therapeutic hypothermia (32°C-34°C for 24 hours) plus standard care or standard care alone between March 2011 and January 2015. The primary endpoint was a Glasgow Outcome Scale score of 5, defining a favorable outcome, 90 days after convulsive status epilepticus.
RESULTS


The 172 men and 93 women had a median age of 57 years (45-68 years). Among them, 130 (49%) had a history of epilepsy, and 59 (29%) had a primary brain insult. Convulsive status epilepticus was refractory in 86 (32%) patients, and total seizure duration was 67 minutes (35-120 minutes). The 90-day outcome was unfavorable in 126 (48%) patients. In multivariate analysis, none of the systemic secondary brain insults were associated with outcome; achieving an unfavorable outcome was associated with age >65 years (odds ratio [OR] 2.17, 95% confidence interval [CI] 1.20-3.85;  p  = 0.01), refractory convulsive status epilepticus (OR 2.00, 95% CI 1.04-3.85;  p  = 0.04), primary brain insult (OR 2.00, 95% CI 1.02-4.00;  p  = 0.047), and no bystander-witnessed seizure onset (OR 2.49, 95% CI 1.05-5.59;  p  = 0.04).
CONCLUSIONS


In our population, systemic secondary brain insults were not associated with outcome in critically ill patients with convulsive status epilepticus.
CLINICALTRIALSGOV IDENTIFIER


NCT01359332.",2020,"By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85;  p  = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85;  p  = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00;  p  = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59;  p  = 0.04).
","['270 critically ill patients with convulsive status epilepticus requiring mechanical ventilation to therapeutic hypothermia (32-34°C for 24 hours) plus standard care or standard care alone, between March 2011 and January 2015', 'patients with convulsive status epilepticus', '172 men and 93 women had a median age of 57 years (45-68']",[],"['Glasgow Outcome Scale score of 5, defining a favorable outcome, 90 days after convulsive status epilepticus', 'total seizure duration', 'refractory convulsive status epilepticus', 'previous history of epilepsy', 'systemic factors (mean arterial blood pressure, arterial partial pressures of carbon dioxide and oxygen, body temperature, natremia, and glycemia', 'bystander-witnessed seizure onset']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3536587', 'cui_str': 'Grand mal status epilepticus, refractory'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455511', 'cui_str': 'H/O: epilepsy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",270.0,0.281843,"By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85;  p  = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85;  p  = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00;  p  = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59;  p  = 0.04).
","[{'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Fontaine', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Lemiale', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Maleka', 'Initials': 'M', 'LastName': 'Schenck', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chelly', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geeraerts', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Aicha', 'Initials': 'A', 'LastName': 'Hamdi', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Guitton', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Mentec', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Cendrine', 'Initials': 'C', 'LastName': 'Chaffaut', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Legriel', 'Affiliation': 'From the Medical-Surgical Intensive Care Unit (C.F.), Hopital Paris Saint Joseph, Paris; IctalGroup (C.F., J.C., S.L.), Le Chesnay; Medical Intensive Care Unit (V.L.) and SBIM Biostatistics and Medical Information (M.R.-R., C.C.), Saint Louis University Hospital; Université Paris Diderot (M.R.-R., C.C.); ECSTRA Team (Epidémiologie Clinique et Statistiques pour la Recherche en Santé) (M.R.-R.), UMR 1153 INSERM, Université Paris Diderot, Sorbonne Paris Cité; Medical Intensive Care Unit (M.S.), Hôpital de Hautepierre, and Medical Intensive Care Unit (F.M.), Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; Medical-Surgical Intensive Care Unit (J.C.), Centre Hospitalier de Melun; Anesthesiology and Critical Care Department (T.G.), Toulouse University Hospital, University Toulouse 3 Paul Sabatier; Medical-Surgical Intensive Care Unit (A.H.), Centre Hospitalier de Montreuil; Medical-Surgical Intensive Care Unit (C.G.), Centre Hospitalier du Mans, Le Mans; EA 7293 (F.M.), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Faculté de Médecine, Université de Strasbourg; Intensive Care Units (J.-Y.L.), Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes; Medical Intensive Care Unit (B.M.), Lariboisiere University Hospital, APHP, Paris; Medical-Surgical Intensive Care Unit (H.M.), Centre Hospitalier Victor Dupouy, Argenteuil; Medical Intensive Care Unit (A.C.), Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP; Paris Descartes University (A.C.), Sorbonne Paris Cité-Medical School; INSERM U970 (A.C.), Paris Cardiovascular Research Center; Intensive Care Department (S.L.), Centre Hospitalier de Versailles-Site André Mignot, Le Chesnay; and Université Paris-Saclay (S.L.), UVSQ, Inserm, CESP, Team DevPsy, Villejuif, France. stlegriel@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010726']
3153,32945536,Intravenous Alcohol Administration Selectively Decreases Rate of Change in Elasticity of Demand in Individuals With Alcohol Use Disorder.,"BACKGROUND


Alcohol demand is a key behavioral economic concept that provides an index of alcohol's relative reinforcing value. Initial studies have reported that alcohol demand increases during alcohol administration and in response to alcohol cues. However, the extent to which these effects are observed explicitly in samples composed of individuals with alcohol use disorder (AUD) and are operative in conjunction with each other has not been studied.
METHODS


To address this gap in the literature, we assessed alcohol demand during an alcohol challenge and subsequent alcohol cue-exposure paradigm in non-treatment-seeking, alcohol-dependent (i.e., DSM-IV criteria) participants (N = 27). Specifically, participants completed 2 counterbalanced intravenous, placebo-controlled, alcohol administration sessions followed by a controlled cue-exposure paradigm. At baseline and at breath alcohol concentration of 0.06 g/dl, participants completed the alcohol purchase task, assessing estimated alcohol consumption at escalating prices. Participants were also assessed for alcohol demand following each cue exposure.
RESULTS


During alcohol administration, there was a significant decrease in the rate of change in elasticity compared with placebo, and during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased the rate of change in elasticity relative to water cues. There were no statistically significant differences in other demand indices.
CONCLUSIONS


These findings provide further evidence that alcohol administration increases price insensitivity and extends the literature on alcohol's effects on demand by using a clinical sample with AUD and by adding a placebo-alcohol condition.",2020,"During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues.","['Individuals with Alcohol Use Disorder', 'non-treatment seeking, alcohol dependent (i.e., DSM-IV criteria) participants (N = 27']","['placebo-controlled, alcohol administration sessions followed by a controlled cue-exposure paradigm']","['rate of change in elasticity', 'elasticity relative to water cues', 'Rate of Change in Elasticity of Demand']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",27.0,0.0258914,"During alcohol administration there was a significant decrease in the rate of change in elasticity compared to placebo, and, during the cue-reactivity paradigm, there was a significant main effect such that alcohol cues decreased rate of change in elasticity relative to water cues.","[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Nieto', 'Affiliation': 'From the, Department of Psychology, (SJN, RG, LAR), University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'From the, Department of Psychology, (SJN, RG, LAR), University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, (JM), McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'From the, Department of Psychology, (SJN, RG, LAR), University of California Los Angeles, Los Angeles, California.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14460']
3154,32945627,Vitamin D supplementation improves anxiety but not depression symptoms in patients with vitamin D deficiency.,"OBJECTIVE


Epidemiological evidence indicated a relationship between vitamin D (VD) and depression with anxiety, but their therapeutic relationship has not been fully elucidated. This study aimed to examine whether VD supplementation would relieve symptoms in patients with depression and anxiety with low serum 25-hydroxy VD [25(OH) D] levels.
METHOD


Participants with low 25(OH)D levels were randomized to control or daily VD group and were followed up for 6 months. Serum concentrations of 25(OH) D were measured using commercial kits. Psychological symptoms were evaluated with the Hamilton Depression Rating Scale-17 (HAMD-17), Revised Social Anhedonia Scale (RSAS), Revised Physical Anhedonia scale (RPAS), and Hamilton Anxiety Rating Scale-14 (HAMA-14). The trial was listed in the trial registration (http://www.medresman.org.cn/uc/index.aspx; NTR number: ChiCTR2000030130).
RESULTS


In this clinical population, no significant difference in depression symptoms was detected between VD group and control group at both baseline and at the endpoint of our study. The HAMD-17, RSAS, and RPAS scores did not change significantly between VD and control groups from baseline to endpoint (all p > .05). However, there was a significant difference in time effect of the total HAMA-14 scores between the two groups (β [95% Cl] = -2.235 [-3.818, -0.653], p = .006).
CONCLUSIONS


Vitamin D supplementation could improve the anxiety symptoms but not depressive symptoms in depressive patients with low VD level after the 6-month intervention.",2020,"The HAMD-17, RSAS, and RPAS scores did not change significantly between VD and control groups from baseline to endpoint (all p > .05).","['Participants with low 25(OH)D levels', 'patients with vitamin D deficiency', 'patients with depression and anxiety with low serum 25-hydroxy VD [25(OH) D']","['VD supplementation', 'vitamin D (VD', 'control or daily VD', 'Vitamin D supplementation']","['Psychological symptoms', 'Hamilton Depression Rating Scale-17 (HAMD-17), Revised Social Anhedonia Scale (RSAS), Revised Physical Anhedonia scale (RPAS), and Hamilton Anxiety Rating Scale-14 (HAMA-14', 'time effect of the total HAMA-14 scores', 'depression symptoms', 'anxiety symptoms', 'HAMD-17, RSAS, and RPAS scores', 'anxiety', 'Serum concentrations of 25(OH']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C3178803', 'cui_str': 'Social Anhedonia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178804', 'cui_str': 'Physical Anhedonia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0490427,"The HAMD-17, RSAS, and RPAS scores did not change significantly between VD and control groups from baseline to endpoint (all p > .05).","[{'ForeName': 'Cuizhen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Yezhe', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jiakuai', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Qingrong', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': 'Department of Maternal, Child & Adolescent Health, School of Public Health, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Dao-Min', 'Initials': 'DM', 'LastName': 'Zhu', 'Affiliation': 'Department of Sleep Disorders, Affiliated Psychological Hospital of Anhui Medical University, Hefei, China.'}]",Brain and behavior,['10.1002/brb3.1760']
3155,32941704,Development and validation of prognostic nomogram in patients with nonmetastatic malignant melanoma: a SEER population-based study.,"BACKGROUND


The condition of tumor recurrence and overall death can be worried in the progress of nonmetastatic malignant melanoma (NMMM). Our goal was to construct and validate a prognostic nomogram from a large population database, which is vital for physicians to predict the 3- and 5-year overall survival (OS) rates of patients with NMMM.
METHODS


According to the Surveillance, Epidemiology, and End Results (SEER) program, patients were collected and randomly assigned into the training and validation cohorts. Several independent risk factors were identified based on the methods of univariable and multivariable cox hazards regression and were incorporated to develop a nomogram. The concordance index (C-index), the area under the receiver operating characteristics (AUC) curve and calibration plot were confirmed to assess predictive power of the nomogram. Decision curve analysis (DCA) was performed to measure nomogram for the clinical practice.
RESULTS


A total of 66192 eligible patients, randomly assigned into 70% of training (n = 46 336) and 30% of validation cohorts (n = 19 856), were selected in this study. The selected independent factors were applied to develop a nomogram, and validated indexes indicated nomogram had a good discrimination ability. The C-index for OS rates was 0.817 (95% CI: 0.811-0.823) in training cohort and 0.817 (95% CI: 0.809-0.825) in validation cohort, respectively. The AUCs of 3- and 5-year OS rates were more than 0.79, and the calibration plots also showed a good power for the nomogram. DCA demonstrated that constructed nomogram can provide clinical net benefit.
CONCLUSION


We constructed a novel nomogram that more accurately and comprehensively predict OS with nonmetastatic malignant melanoma patients, which is vital for clinician to improve individual treatment, make reasonable clinical decisions, and set appropriate follow-up strategies.",2020,"The C-index for OS rates was 0.817 (95% CI: 0.811-0.823) in training cohort and 0.817 (95% CI: 0.809-0.825) in validation cohort, respectively.","['66192 eligible patients, randomly assigned into 70% of training (n\xa0', '46\xa0336) and 30% of validation cohorts (n\xa0=\xa019\xa0856', 'patients with nonmetastatic malignant melanoma', 'nonmetastatic malignant melanoma patients', 'patients with NMMM']",['DCA'],"['concordance index (C-index), the area under the receiver operating characteristics (AUC) curve and calibration plot', 'AUCs of 3- and 5-year OS rates', '5-year overall survival (OS) rates', 'C-index for OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517894', 'cui_str': '856'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",66192.0,0.149323,"The C-index for OS rates was 0.817 (95% CI: 0.811-0.823) in training cohort and 0.817 (95% CI: 0.809-0.825) in validation cohort, respectively.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'The Central Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Peng', 'Affiliation': 'The Central Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Youhong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Xiaogan, Xiaogan, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, China.'}, {'ForeName': 'Xianwei', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, China.'}]",Cancer medicine,['10.1002/cam4.3318']
3156,32941917,Low-Dose IL-2 for Treating Moderate to Severe Alopecia Areata: A 52-Week Multicenter Prospective Placebo-Controlled Study Assessing Its Impact on T Regulatory Cell and NK Cell Populations.,,2020,,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0293259,,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Le Duff', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Jean-David', 'Initials': 'JD', 'LastName': 'Bouaziz', 'Affiliation': 'Department of Dermatology, Hôpital Saint-Louis et Université de Paris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ticchioni', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Manuelle', 'Initials': 'M', 'LastName': 'Viguier', 'Affiliation': 'Department of Dermatology-Venereology, Centre Hospitalier Universitaire Reims, Reims, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dereure', 'Affiliation': 'Department of Dermatology and INSERM UMR 1058 Pathogenesis and Control of Chronic Infections, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Reygagne', 'Affiliation': 'Department of Dermatology, Hôpital Saint-Louis et Université de Paris, Paris, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Monestier', 'Affiliation': 'Department of Dermatology, Assistance Publique des Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Marie-Aleth', 'Initials': 'MA', 'LastName': 'Richard', 'Affiliation': 'Department of Dermatology, Hospital Universitaire La Timone, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Côte d'Azur, Nice, France; Team 12, C3M, INSERM U1065, Université Côte d'Azur, Nice, France. Electronic address: passeron@unice.fr.""}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.08.015']
3157,32946353,Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial.,"PURPOSE


We conducted the phase III double-blind European Organisation for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 trial to evaluate pembrolizumab versus placebo in patients with resected high-risk stage III melanoma. On the basis of 351 recurrence-free survival (RFS) events at a 1.25-year median follow-up, pembrolizumab prolonged RFS (hazard ratio [HR], 0.57;  P  < .0001) compared with placebo. This led to the approval of pembrolizumab adjuvant treatment by the European Medicines Agency and US Food and Drug Administration. Here, we report an updated RFS analysis at the 3.05-year median follow-up.
PATIENTS AND METHODS


A total of 1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma were randomly assigned to receive pembrolizumab at a flat dose of 200 mg (n = 514) or placebo (n = 505) every 3 weeks for 1 year or until disease recurrence or unacceptable toxicity. The two coprimary end points were RFS in the overall population and in those with programmed death-ligand 1 (PD-L1)-positive tumors.
RESULTS


Pembrolizumab (190 RFS events) compared with placebo (283 RFS events) resulted in prolonged RFS in the overall population (3-year RFS rate, 63.7%  v  44.1% for pembrolizumab  v  placebo, respectively; HR, 0.56; 95% CI, 0.47 to 0.68) and in the PD-L1-positive tumor subgroup (HR, 0.57; 99% CI, 0.43 to 0.74). The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and  BRAF  mutation status (HR, 0.51 [99% CI, 0.36 to 0.73]  v  0.66 [99% CI, 0.46 to 0.95] for V600 E/K   v  wild type).
CONCLUSION


In resected high-risk stage III melanoma, pembrolizumab adjuvant therapy provided a sustained and clinically meaningful improvement in RFS at 3-year median follow-up. This improvement was consistent across subgroups.",2020,"The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and  BRAF  mutation status (HR, 0.51","['High-Risk Stage III Melanoma', 'Cancer (EORTC', 'patients with resected high-risk stage III melanoma', '1,019 patients with complete lymph node dissection of American Joint Committee on Cancer Staging Manual (seventh edition; AJCC-7), stage IIIA (at least one lymph node metastasis > 1 mm), IIIB, or IIIC (without in-transit metastasis) cutaneous melanoma']","['pembrolizumab versus placebo', 'placebo', 'pembrolizumab', 'Adjuvant Pembrolizumab']","['351 recurrence-free survival (RFS) events', 'RFS', 'overall population (3-year RFS rate']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1019.0,0.783931,"The impact of pembrolizumab on RFS was similar in subgroups, in particular according to AJCC-7 and AJCC-8 staging, and  BRAF  mutation status (HR, 0.51","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Princess Máxima Center, Utrecht, the Netherlands.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Victoria G', 'Initials': 'VG', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon, France.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Meshcheryakov', 'Affiliation': 'N.N. Blokhin Cancer Research Center, Moscow, Russian Federation.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital and Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic Universitari de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale,"" Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, the Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus J M', 'Initials': 'AJM', 'LastName': 'van den Eertwegh', 'Affiliation': 'Amsterdam University Medical Center, location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal (CHUM), Centre de recherche du CHUM, Montreal, Quebec, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Alexander C J', 'Initials': 'ACJ', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Saclay University, Villejuif, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02110']
3158,32946355,Consolidation Radiotherapy Could Be Safely Omitted in Advanced Hodgkin Lymphoma With Large Nodal Mass in Complete Metabolic Response After ABVD: Final Analysis of the Randomized GITIL/FIL HD0607 Trial.,"PURPOSE


To investigate the role of consolidation radiotherapy (cRT) in advanced-stage Hodgkin lymphoma (HL) presenting at baseline with a large nodal mass (LNM) in complete metabolic response after doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy.
PATIENTS AND METHODS


Advanced-stage (IIB-IVB) HL patients, enrolled in the HD 0607 trial (Clinicaltrial.gov identifier NCT00795613), with both a negative PET after two (PET-2) and six (PET-6) ABVD cycles, who presented at baseline with an LNM, defined as a nodal mass with the largest diameter ≥ 5 cm, were prospectively randomly assigned to receive cRT over the LNM or no further treatment (NFT).
RESULTS


Among 296 randomly assigned patients, the largest diameter of LNM at baseline was 5-7 cm in 101 (34%; subgroup A) and 8-10 cm in 96 (32%; subgroup B), whereas classic bulky (diameter > 10 cm) was detected in 99 (33%; subgroup C). Two hundred eighty patients (88%) showed a postchemotherapy RM. The median dose of cRT was 30.6 Gy (range, 24-36 Gy). After a median follow-up of 5.9 years (range, 0.5-10 years), the 6-year progression-free survival rate of patients who underwent cRT or NFT was, respectively, 91% (95% CI, 84% to 99%) and 95% (95% CI, 89% to 100%;  P  = .62) in subgroup A; 98% (95% CI, 93% to 100%) and 90% (95% CI, 80% to 100%;  P  = .24) in subgroup B; 89% (95% CI, 81% to 98%) and 86% (95% CI, 77% to 96%;  P  = .53) in subgroup C (classic bulky).
CONCLUSION


cRT could be safely omitted in patients with HL presenting with an LNM and a negative PET-2 and PET-6 scan, irrespective from the LNM size detected at baseline.",2020,"CONCLUSION


cRT could be safely omitted in patients with HL presenting with an LNM and a negative PET-2 and PET-6 scan, irrespective from the LNM size detected at baseline.","['Advanced-stage', 'patients with HL presenting with an LNM', 'advanced-stage Hodgkin lymphoma (HL) presenting at baseline with a large nodal mass (LNM) in complete metabolic response after', 'IIB-IVB) HL patients, enrolled in the HD 0607 trial (Clinicaltrial.gov identifier NCT00795613), with both a negative PET after two (PET-2) and six (PET-6) ABVD cycles, who presented at baseline with an LNM, defined as a nodal mass with the largest diameter ≥ 5 cm', 'Two hundred eighty patients (88%) showed a postchemotherapy RM', 'Advanced Hodgkin Lymphoma']","['doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy', 'NFT', 'Consolidation Radiotherapy', 'cRT over the LNM or no further treatment (NFT', 'consolidation radiotherapy (cRT']","['6-year progression-free survival rate', 'Complete Metabolic Response']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0050380', 'cui_str': 'ABVD-I protocol'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",296.0,0.392528,"CONCLUSION


cRT could be safely omitted in patients with HL presenting with an LNM and a negative PET-2 and PET-6 scan, irrespective from the LNM size detected at baseline.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallamini', 'Affiliation': 'Research and Clinical Innovation Department, A. Lacassagne Cancer Center, Nice, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Hematology, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Patti', 'Affiliation': 'Hematology, V. Cervello Hospital, Palermo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Hematology, Policlinico Federico II Hospital, Naples, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Romano', 'Affiliation': 'Hematology, Policlinico Vittorio Emanuele Hospital, Catania, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cantonetti', 'Affiliation': 'Hematology, Policlinico Universitario Tor Vergata, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Oppi', 'Affiliation': 'Department of Hematology, Businco Hospital, Cagliari, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Viviani', 'Affiliation': 'Department of Hematology, IRCCS National Institute of Tumors, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bolis', 'Affiliation': 'Hematology, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Trentin', 'Affiliation': 'Hematology, Medicine, Padua University, Padua, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Gini', 'Affiliation': 'Hematology, Ospedali Riuniti Le Torrette, Ancona, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Battistini', 'Affiliation': 'Hematology, San Camillo Forlanini Hospital, Rome, Italy.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Chauvie', 'Affiliation': 'Medical Physics Unit, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sorasio', 'Affiliation': 'Hematology, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'Hematology, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Zanotti', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cimminiello', 'Affiliation': 'Hematology, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Schiavotto', 'Affiliation': 'Hematology, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Piera', 'Initials': 'P', 'LastName': 'Viero', 'Affiliation': ""Hematology Ospedale dell'Angelo, Mestre, Venice, Italy.""}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Mulé', 'Affiliation': 'Hematology, V. Cervello Hospital, Palermo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fallanca', 'Affiliation': 'Nuclear Medicine Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Ficola', 'Affiliation': 'Nuclear Medicine Department, La Maddalena Hospital, Palermo, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tarella', 'Affiliation': 'Onco-Hematology European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Guerra', 'Affiliation': 'Nuclear Medicine, San Gerardo University Hospital, Monza, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Hematology, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00935']
3159,32947558,Population Pharmacokinetic Modeling of Vancomycin in Thai Patients With Heterogeneous and Unstable Renal Function.,"BACKGROUND


Vancomycin is widely used to treat gram-positive bacterial infections. However, given significant interpatient variability in its pharmacokinetics, maintaining plasma concentrations is difficult within its characteristically narrow therapeutic window. This is especially challenging in patients with unstable renal function. Thus, the aim of this study was to develop a population pharmacokinetic model for vancomycin that is suitable for Thai patients with variable renal functions, including those with unstable renal function.
METHODS


Data from 213 patients, including 564 blood samples, were retrospectively collected; approximately 70% patients exhibited unstable renal function during vancomycin treatment. The model building group was randomly assigned 108 patients and the remaining 33 patients comprised the validation group. A population pharmacokinetic model was developed that incorporated drug clearance (CL) as a function of time-varying creatine clearance (CrCL). The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
RESULTS


A 2-compartment model with drug CL values that changed with time-varying CrCL adequately described vancomycin pharmacokinetics in the evaluated heterogeneous patient population with unstable renal function. Vancomycin CL was related to time-varying CrCL as follows: CL (t) = 0.11 + 0.021 × CrCL (t) (CrCL <120 mL/min. Using the population model, Bayesian estimation with at least one measured serum concentration resulted in a forecasting error of small bias (-2.4%) and adequate precision (31.5%).
CONCLUSIONS


In hospitals with a high incidence of unstable renal function, incorporating time-varying CrCL with Bayesian estimation and at least one measured drug concentration, along with frequent CrCL monitoring, improves the predictive performance of therapeutic drug monitoring of vancomycin.",2020,"The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
","['Thai Patients with Heterogeneous and Unstable Renal Function', 'heterogeneous patient population with unstable renal function', 'patients with unstable renal function', 'Data from 213 patients, including 564 blood samples, were retrospectively collected; approximately 70% patients exhibited unstable renal function during vancomycin treatment', 'Thai patients with variable renal functions, including those with unstable renal function']","['Vancomycin CL', 'Vancomycin', 'vancomycin']",[],"[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",[],108.0,0.0230478,"The predictive ability of the resulting population model was evaluated using the validation data set, including its ability to forecast serum concentrations within a Bayesian feedback algorithm.
","[{'ForeName': 'Siriluk', 'Initials': 'S', 'LastName': 'Jaisue', 'Affiliation': 'Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University.'}, {'ForeName': 'Cholatip', 'Initials': 'C', 'LastName': 'Pongsakul', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'DʼArgenio', 'Affiliation': 'Biomedical Simulations Resource, Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Pakawadee', 'Initials': 'P', 'LastName': 'Sermsappasuk', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000801']
3160,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
3161,32949986,Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).,"BACKGROUND


Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population.
METHODS


Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017. Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA 2 DS 2 -VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis. The main outcome measures of the current analysis were rates of OAC use in the prior 12 months of cohort identification and factors associated with non-use.
RESULTS


A total of 197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment. Of these, 179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old. Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis. Of these, 32,295 (33%) had no evidence of OAC use in the prior 12 months. Compared with patients with evidence of OAC use in the prior 12 months, patients without OAC use were more likely to be ≥80 years old, women, and have a history of anemia (51% vs 47%) and less likely to have diabetes (41% vs 44%), history of stroke or TIA (15% vs 19%), and history of heart failure (39% vs 48%).
CONCLUSIONS


Despite a high risk of stroke, one-third of privately insured patients with AF and no obvious contraindications to an OAC were not treated with an OAC. There is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.",2020,"Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis.","['Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017', 'patients with Atrial Fibrillation (IMPACT-AFib', '197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment', '179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old', 'patients with AF at risk for stroke', 'patients with atrial fibrillation (AF', 'Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA 2 DS 2 -VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis', 'privately insured patients with atrial fibrillation', 'Half of the patients (98,903']","['oral anticoagulants (OACs', 'OACs', 'oral AntiCoagulanTs', 'oral anticoagulants']","['rates of OAC use', 'history of anemia', 'history of heart failure', 'history of stroke or TIA']","[{'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0559154', 'cui_str': 'H/O: anemia'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]",197806.0,0.0480647,"Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis.","[{'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: alkha001@mc.duke.edu.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., Wilmington, DE.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Goldsack', 'Affiliation': 'The Clinical Trials Transformation Initiative, Durham, NC.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harkins', 'Affiliation': 'Humana Healthcare Research, Louisville, KY.'}, {'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Cocoros', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Lin', 'Affiliation': 'OptumInsight Life Sciences, Boston, MA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lipowicz', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'McCall', 'Affiliation': 'Rowan Tree Perspectives Consulting, Murrieta, CA.'}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Humana Healthcare Research, Louisville, KY.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Parlett', 'Affiliation': 'HealthCore, Inc., Wilmington, DE.'}, {'ForeName': 'Cheryl N', 'Initials': 'CN', 'LastName': 'McMahill-Walraven', 'Affiliation': 'Aetna, Inc., Blue Bell, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2020.07.012']
3162,32950830,Montelukast combined with intranasal mometasone furoate versus intranasal mometasone furoate; a comparative study in treatment of adenoid hypertrophy.,"OBJECTIVES


To evaluate the role of combined therapy using montelukast and intranasal mometasone furoate compared to intranasal mometasone furoate alone in treatment of adenoid hypertrophy regarding efficacy and recurrence rate.
METHODS


The study included 100 children with adenoid hypertrophy, they were randomly assigned to two groups. Group I (50 patients) received combined therapy using montelukast and mometasone furoate nasal spray. Group II (50 patients) received only mometasone furoate nasal spray. Patients were treated for 3 months and observed for 3 months after stoppage of treatment. Patients were evaluated using symptoms scores, Adenoid/Nasopharyngeal ratio and endoscopic grading of adenoid hypertrophy.
RESULTS


After 3 months of treatment, group I showed significant better scores of main symptoms than group II; (P = 0.001), (P = 0.019) and (P = 0.008) for rhinorrhea, mouth breathing and snoring respectively. The mean A/N ratio was 52.8 ± 11.3 in group I better than 62.88 ± 12.10 in group II (P < 0.001). Regarding the adenoid hypertrophy grading, significant reduction in size was found in group I in 34 (68%) patients better than in group II in 18 (36%) patients (P = 0.001). After further 3 months of follow up, the mean A/N ratio was 58.46 ± 10.05 in group I better than 66.36 ± 10.46 in group II (P < 0.001). Recurrence occurred in 8 (23.5%) cases out of 34 improved cases in group I better than 10 (55.5%) cases out of 18 cases in group II (P = 0.02).
CONCLUSION


Combining oral montelukast with intranasal mometasone in treatment of adenoid hypertrophy provided better improvements and less recurrence in comparison with single therapy using intranasal mometasone alone.",2020,"After 3 months of treatment, group I showed significant better scores of main symptoms than group II; (P = 0.001),","['adenoid hypertrophy', '100 children with adenoid hypertrophy']","['mometasone furoate nasal spray', 'intranasal mometasone furoate', 'combined therapy using montelukast and mometasone furoate nasal spray', 'montelukast and intranasal mometasone furoate', 'Montelukast combined with intranasal mometasone furoate', 'intranasal mometasone']","['rhinorrhea, mouth breathing and snoring respectively', 'Recurrence', 'scores of main symptoms', 'symptoms scores, Adenoid/Nasopharyngeal ratio and endoscopic grading of adenoid hypertrophy']","[{'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}]","[{'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}]",100.0,0.0279045,"After 3 months of treatment, group I showed significant better scores of main symptoms than group II; (P = 0.001),","[{'ForeName': 'Aboubakr Elshafey', 'Initials': 'AE', 'LastName': 'Ras', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Mona Hosny', 'Initials': 'MH', 'LastName': 'Hamed', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Abdelrahman Ahmed', 'Initials': 'AA', 'LastName': 'Abdelalim', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt. Electronic address: abdelrahman.ahmed@fmed.bu.edu.eg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102723']
3163,32950885,First night effect on polysomnographic sleep bruxism diagnosis varies among young subjects with different degrees of rhythmic masticatory muscle activity.,"OBJECTIVE


This study investigated the first night effect on the polysomnographic diagnosis of sleep bruxism (SB).
METHODS


Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7 ± 0.32 years [range: 20.0-33.0]). Sleep variables and rhythmic masticatory muscle activity (RMMA) were scored for two nights. The diagnosis of SB was graded by the frequency of RMMA with cut-off values of two and four times per hour of sleep.
RESULTS


Participants were classified into control (n = 15), low (n = 13) and moderate-high (n = 15) groups. Among the three groups, the concordance of the SB diagnosis was compared between the two nights. Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals. The frequency of RMMA significantly increased from the first to the second night in the moderate-high SB group only. The concordance rate of the severity between the two nights was 93.3% (14/15) in the control group, 76.9% (10/13) in the low SB group and 60% (9/15) in the moderate-high SB group. When the severity was determined on the first night, it remained the same on the second night in 77.8% (14/18) of the control group, 66.7% (10/15) of the low SB group and 90.0% (9/10) of the moderate-high SB group.
CONCLUSION


The results showed that the first night effect on the occurrence of RMMA differed among the different degrees of the RMMA frequency, and suggest that, due to the first night effect, single-night polysomnography may underestimate the moderate-high level of SB but differentiate the low level of SB from controls.",2020,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","['Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7\xa0±\xa00.32 years [range: 20.0-33.0', 'young subjects with different degrees of rhythmic masticatory muscle activity', 'Participants were classified into control (n\xa0=\xa015), low (n\xa0=\xa013) and moderate-high (n\xa0=\xa015) groups']",[],"['concordance of the SB diagnosis', 'sleep efficiency, longer sleep latency and higher frequency of arousals', 'Sleep variables and rhythmic masticatory muscle activity (RMMA', 'occurrence of RMMA', 'frequency of RMMA', 'polysomnographic diagnosis of sleep bruxism (SB', 'concordance rate of the severity']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0114225,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Haraki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tsujisaka', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Toyota', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Oral Rehabilitation, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Osaka University Graduate School of Dentistry, 1-8, Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': 'Health and Counseling Center, Osaka University, 1-17 Machikaneyama-Cho, Toyonaka, Osaka, 560-0043, Japan; Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ishigaki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Taniike', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan. Electronic address: takafumi@dent.osaka-u.ac.jp.'}]",Sleep medicine,['10.1016/j.sleep.2020.08.012']
3164,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND


In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION


The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS


Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS


The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE


The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
3165,32951766,"The Acute Effects of Manual and Instrument-Assisted Cervical Spine Manipulation on Pressure Pain Threshold, Pressure Pain Perception, and Muscle-Related Variables in Asymptomatic Subjects: A Randomized Controlled Trial.","OBJECTIVE


The purpose of this study was to compare the immediate effects in asymptomatic participants of manual and instrument-assisted cervical manipulation on pressure pain thresholds, pressure pain perception, and muscle mechanical properties (tone, stiffness, and elasticity) over muscles anatomically related and unrelated to the manipulated level.
METHODS


Fifty-nine asymptomatic participants (34 women and 25 men; age [mean ± standard deviation] = 21.1 ± 1.6 years) were randomly assigned to 4 groups in a double-blind, randomized, placebo-controlled trial. Two groups received cervical (C3/C4) manipulation, 1 manual and the other instrument-assisted; the third group received a sham manipulation; and the fourth group served as the control. Bilateral pressure pain threshold, pressure pain perception, muscle tone, stiffness, and elasticity in the upper trapezius and biceps brachii were evaluated before and immediately after the interventions.
RESULTS


At baseline, there were no differences among the groups on any variable. After the interventions, a significant increase in pressure pain threshold was observed with both manual and instrument-assisted manipulation at local and distal sites (P < .05), whereas no changes were observed in either the control or the placebo group. The perception of pain pressure did not change significantly in any group. The interventions did not promote any statistically significant differences in muscle tone, elasticity, or stiffness at any site (local or distal).
CONCLUSION


Cervical (C3/C4) manual and instrument-assisted manipulations produced an increase in pressure pain threshold bilaterally and over muscles related and unrelated to the vertebral segment, but had no effect on muscle tone, elasticity, or stiffness.",2020,"The interventions did not promote any statistically significant differences in muscle tone, elasticity, or stiffness at any site (local or distal).
","['asymptomatic participants of', 'Asymptomatic Subjects', 'Fifty-nine asymptomatic participants (34 women and 25 men; age [mean ± standard deviation]\u202f=\u202f21.1 ± 1.6 years']","['Manual and Instrument-Assisted Cervical Spine Manipulation', 'placebo', 'Cervical (C3/C4) manual and instrument-assisted manipulations', 'cervical (C3/C4) manipulation, 1 manual and the other instrument-assisted; the third group received a sham manipulation', 'manual and instrument-assisted cervical manipulation']","['pressure pain threshold', 'Bilateral pressure pain threshold, pressure pain perception, muscle tone, stiffness, and elasticity in the upper trapezius and biceps brachii', 'perception of pain pressure', 'pressure pain thresholds, pressure pain perception, and muscle mechanical properties (tone, stiffness, and elasticity', 'Pressure Pain Threshold, Pressure Pain Perception, and Muscle-Related Variables', 'muscle tone, elasticity, or stiffness', 'pressure pain', 'muscle tone, elasticity, or stiffness at any site (local or distal']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0203928', 'cui_str': 'Manipulation of the cervical spine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0600576', 'cui_str': 'Neck manipulation'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]",59.0,0.148268,"The interventions did not promote any statistically significant differences in muscle tone, elasticity, or stiffness at any site (local or distal).
","[{'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Nogueira', 'Affiliation': 'Vale do Sousa Higher School of Health, Polytechnic Health School of the North, Cooperativa de Ensino Superior Politécnico e Universitário (CESPU), Gandra, Portugal; Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal. Electronic address: nunogueira@gmail.com.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Oliveira-Campelo', 'Affiliation': 'Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Ângela', 'Initials': 'Â', 'LastName': 'Lopes', 'Affiliation': 'Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Torres', 'Affiliation': 'Vale do Sousa Higher School of Health, Polytechnic Health School of the North, Cooperativa de Ensino Superior Politécnico e Universitário (CESPU), Gandra, Portugal; Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Andreia S P', 'Initials': 'ASP', 'LastName': 'Sousa', 'Affiliation': 'Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'School of Health Sciences and Institute of Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.05.007']
3166,32955913,"Modulatory Effects of Triphala and Manjistha Dietary Supplementation on Human Gut Microbiota: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.","Objectives:  Triphala (which contains  Emblica officinalis, Terminalia bellerica,  and  Terminalia chebula ) and manjistha ( Rubia cordifolia ), have received increased clinical attention. The aim of the study was to evaluate the effects of triphala, manjistha, or placebo dietary supplementation on gut microbiota as such studies in humans are lacking.  Design:  This was a 4-week randomized, double-blind, placebo-controlled pilot trial.  Setting:  This trial was conducted at the University of California Davis, Department of Dermatology.  Subjects:  A total of 31 healthy human subjects were randomized to 3 groups.  Interventions:  The 3 groups were instructed to take 2,000 mg of either triphala, manjistha or placebo daily for 4 weeks.  Outcome Measures:  The impact of treatment on gut microbiota composition was evaluated following a 4-week dietary intervention by profiling fecal communities with 16S rRNA profiling in triphala ( n  = 9), manjistha ( n  = 9), or placebo ( n  = 11) treated subjects that completed the intervention.  Results:  An average of 336 phylotypes were detected in each sample (range: 161 to 648). The analysis of gut microbiota in placebo control and herb-supplemented participants indicated that responses were highly personalized, and no taxa were uniformly altered by the medicinal herb supplementation protocol. Subjects in both treatment groups displayed a trend toward decreased Firmicutes to Bacteroidetes ratio and increased relative abundance of  Akkermansia muciniphila . Both medicinal herb treatments reduced the relative abundance of Rikenellaceae, primarily reflecting changes in  Alistipes  spp.  Conclusions:  Dietary supplementation with medicinal herbs altered fecal microbial communities. Despite the lack of a clear response signature, a group of bacterial taxa were identified that were more commonly altered in herb-supplemented participants compared to placebo controls. Clinicaltrials.gov identifier NCT03477825.",2020,"Both medicinal herb treatments reduced the relative abundance of Rikenellaceae, primarily reflecting changes in  Alistipes  spp.  ","['31 healthy human subjects', 'altered fecal microbial communities', 'University of California Davis, Department of Dermatology', 'Human Gut Microbiota', 'fecal communities with 16S rRNA profiling in triphala ( n \u2009=\u20099), manjistha ( n \u2009=\u20099), or', 'Subjects']","['Dietary supplementation with medicinal herbs', 'Triphala and Manjistha Dietary Supplementation', 'placebo', 'triphala, manjistha or placebo', 'Placebo', 'triphala, manjistha, or placebo dietary supplementation']","['Firmicutes to Bacteroidetes ratio and increased relative abundance of  Akkermansia muciniphila ', 'gut microbiota composition', 'relative abundance of Rikenellaceae']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C1958185', 'cui_str': 'triphala'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C1958185', 'cui_str': 'triphala'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1080664', 'cui_str': 'Rikenellaceae'}]",31.0,0.466214,"Both medicinal herb treatments reduced the relative abundance of Rikenellaceae, primarily reflecting changes in  Alistipes  spp.  ","[{'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Peterson', 'Affiliation': 'Department of Family Medicine and Public Health, Center of Excellence for Research and Training in Integrative Health, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Aunna', 'Initials': 'A', 'LastName': 'Pourang', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Jordan N', 'Initials': 'JN', 'LastName': 'Kohn', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Uchitel', 'Affiliation': 'Department of Biology, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Harjot', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Naturopathic Medicine, Bastyr University San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': 'Department of Family Medicine and Public Health, Center of Excellence for Research and Training in Integrative Health, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Peterson', 'Affiliation': 'Tumor Microenvironment and Cancer Immunology Program, Sanford Burnham Prebys Medical Discovery Institute, La Jolla, CA, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0148']
3167,32956906,Reality check: An experimental manipulation of inferential confusion in eating disorders.,"BACKGROUND AND OBJECTIVES


Inferential confusion (IC) entails confusing an imagined possibility with a sensory-based possibility, and acting upon the imagined possibility as if it was real. Although IC was formulated in the context of obsessive-compulsive disorder (OCD), this reasoning bias has shown to be relevant to other obsessive-compulsive spectrum disorders, such as eating disorders (EDs). The goal of this study was to induce IC experimentally in individuals with EDs relative to healthy controls (HC).
METHODS


Thirty-six women (ED group, n = 18; HC group, n = 18) were assigned to one of two experimental conditions: in the High IC condition, participants watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC. In the Low IC condition, participants watched videos without sequences missing. Participants completed measures of IC, negative affect and compulsive behaviors after watching the videos.
RESULTS


One-way ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors. ED participants also neutralized more after watching the videos and endorsed higher trait IC.
LIMITATIONS


There was no clinical control group.
CONCLUSIONS


These findings suggest that individuals with EDs display a greater vulnerability to IC, as they are more prone to compulsive behaviors when IC is triggered. This investigation may foster our understanding of the relationship between EDs and OCD through the examination of cognitive factors that are implicated in both disorders.",2021,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"['Thirty-six women (ED group, n\xa0=\xa018', 'individuals with EDs relative to healthy controls (HC', 'eating disorders']","['watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC']","['urge to engage in compulsive behaviors', 'IC, negative affect and compulsive behaviors']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0589645,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouellet-Courtois', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychology Department, Canada. Electronic address: catherine.ouellet-courtois@umontreal.ca.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Aardema', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101614']
3168,32907801,Two-year cost effectiveness between two gradual tapering strategies in rheumatoid arthritis: cost-utility analysis of the TARA trial.,"OBJECTIVE


The aim of the current study was to evaluate the 2-year cost-utility ratio between tapering conventional synthetic disease-modifying antirheumatic drugs (csDMARD) first followed by the tumour necrosis factor (TNF)-inhibitor, or vice versa, in patients with rheumatoid arthritis (RA).
METHODS


Two-year data of the Tapering strategies in Rheumatoid Arthritis trial were used. Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months, were randomised into gradual tapering the csDMARD first followed by the TNF-inhibitor, or vice versa. Quality-adjusted life years (QALYs) were derived from the European Quality of life questionnaire with 5 dimensions. Healthcare and productivity costs were calculated with data from patient records and questionnaires. The incremental cost-effectiveness ratio and the incremental net monetary benefit were used to assess cost effectiveness between both tapering strategies.
RESULTS


94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first. QALYs (SD) were, respectively, 1.64 (0.22) and 1.65 (0.22). Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10). Therefore, total costs (SD) were €38 833 (€39 616) for tapering csDMARDs first, and €39 442 (€47 271) for tapering the TNF-inhibitor (p=0.88). For willingness-to-pay (WTP) levels <€83 800 tapering, the csDMARD first has the highest probability of being cost effective, while for WTP levels >€83 800 tapering the TNF-inhibitor first has the highest probability.
CONCLUSION


Our economic evaluation shows that costs are similar for both tapering strategies. Regardless of the WTP, tapering either the TNF-inhibitor or the csDMARD first is equally cost effective.
TRIAL REGISTRATION NUMBER


NTR2754.",2020,"Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10).","['rheumatoid arthritis', '94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first', 'patients with rheumatoid arthritis (RA', 'Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months']",['conventional synthetic disease-modifying antirheumatic drugs (csDMARD'],"['2-year cost-utility ratio', 'productivity loss', 'WTP levels', 'Quality-adjusted life years (QALYs', 'cost effectiveness', 'Medication costs', 'European Quality of life', 'incremental cost-effectiveness ratio', 'total costs (SD', 'Healthcare and productivity costs']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0243286,"Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10).","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tjallingius Martijn', 'Initials': 'TM', 'LastName': 'Kuijper', 'Affiliation': 'Rheumatology, Maasstad Hospital, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'N H A M', 'Initials': 'NHAM', 'LastName': 'Denissen', 'Affiliation': 'Rheumatology, Amphia Hospital, Breda, North Brabant, The Netherlands.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Gerards', 'Affiliation': 'Rheumatology, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'de Jager', 'Affiliation': 'Rheumatology, Albert Schweitzer Hospital, Dordrecht, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Wai-Kwan', 'Initials': 'WK', 'LastName': 'Lam-Tse', 'Affiliation': 'Rheumatology, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jolanda J', 'Initials': 'JJ', 'LastName': 'Luime', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217528']
3169,32910710,Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: CheckMate 153.,"PURPOSE


Limited data exist on the optimal duration of immunotherapy, including for non-small-cell lung cancer (NSCLC). We present an exploratory analysis of CheckMate 153, a largely community-based phase IIIb/IV study, to evaluate the impact of 1-year fixed-duration versus continuous therapy on the efficacy and safety of nivolumab.
METHODS


Patients with previously treated advanced NSCLC received nivolumab monotherapy (3 mg/kg every 2 weeks). Those still receiving treatment at 1 year, including patients perceived to be deriving benefit despite radiographic progression, were randomly assigned to continue nivolumab until disease progression or unacceptable toxicity or to stop nivolumab with the option of on-study retreatment after disease progression (1-year fixed duration).
RESULTS


Of 1,428 patients treated, 252 were randomly assigned to continuous (n = 127) or 1-year fixed-duration (n = 125) treatment (intent-to-treat [ITT] population). Of these, 89 and 85 patients in the continuous and 1-year fixed-duration arms, respectively, had not progressed (progression-free survival [PFS] population). With minimum post-random assignment follow-up of 13.5 months, median PFS was longer with continuous versus 1-year fixed-duration treatment (PFS population: 24.7 months  v  9.4 months; hazard ratio [HR], 0.56 [95% CI, 0.37 to 0.84]). Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached  v  32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached  v  28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations. Few new-onset treatment-related adverse events occurred. No new safety signals were identified.
CONCLUSION


To our knowledge, these findings from an exploratory analysis represent the first randomized data on continuous versus fixed-duration immunotherapy in previously treated advanced NSCLC and suggest that continuing nivolumab beyond 1 year improves outcomes.",2020,"Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached  v  32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached  v  28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations.","['1,428 patients treated', 'Patients with previously treated advanced NSCLC received']","['nivolumab monotherapy', 'Continuous Versus 1-Year Fixed-Duration Nivolumab']","['Median overall survival', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1428.0,0.208119,"Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached  v  32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached  v  28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Waterhouse', 'Affiliation': 'The US Oncology Network/Oncology Hematology Care, Cincinnati, OH.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at UCLA/Translational Research in Oncology-US Network, Los Angeles, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'West Cancer Center, Memphis, TN.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Sarah Cannon Research Institute/Florida Cancer Specialists, Cape Coral, FL.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Sarah Cannon Research Institute/Florida Cancer Specialists, The Villages, FL.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jotte', 'Affiliation': 'The US Oncology Network/Rocky Mountain Cancer Centers, Denver, CO.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Davey B', 'Initials': 'DB', 'LastName': 'Daniel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Chattanooga, TN.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Keogh', 'Affiliation': 'Charleston Oncology, Charleston, SC.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Creelan', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Einhorn', 'Affiliation': 'Simon Cancer Center, Indiana University, Indianapolis, IN.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Jackson Oncology Associates, Jackson, MS.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Kasbari', 'Affiliation': 'Southeastern Medical Oncology Center, Goldsboro, NC.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Nikolinakos', 'Affiliation': 'Hematology and Medical Oncology, University Cancer and Blood Center, LLC, Athens, GA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'CISSS Chaudiéere-Appalaches, Levis, Quebec, Canada.'}, {'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Sarah Cannon Research Institute/Florida Cancer Specialists, Ocala, FL.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Gunuganti', 'Affiliation': 'Texas Oncology, San Antonio, TX.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, NJ.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Aanur', 'Affiliation': 'Bristol Myers Squibb Company, Princeton, NJ.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00131']
3170,32911733,Impact of Short Foot Muscle Exercises on Quality of Movement and Flexibility in Amateur Runners.,"The flexibility and proper functioning of all myofascial chains are crucial for athletes, especially for long-distance runners. Due to the continuity of the myofascial structures, restrictions in one part of the body may cause excessive tension in others. The aim of our study was to evaluate the influence of short foot muscle exercises on muscle flexibility and the quality of movement patterns in amateur runners. Eighty long-distance runners, aged 20-45, were randomly divided into two groups: Group 1 ( n  = 48) and Group 2 ( n  = 32). Participants in Group 1 performed foot exercises daily for six weeks. Subjects in Group 2 were without any intervention. At baseline and after six weeks, the quality of movement patterns with the Functional Movement Screen and muscle flexibility was evaluated. In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks. The total score increased from 17 to 18 points (Median (Me) ± half of interquartile range (IQR/2) (Standard Error of Measurement - SEM) 17 ± 1.5 (0.23) at baseline and 18 ± 1.5 (0.24) after six weeks) ( p  < 0.01), whereas in Group 2, its level remained at 16 points (Me ± IQR/2 (SEM) 16 ± 1.5 (0.31) at baseline and 16 ± 1.25 (0.31) after six weeks). In Group 1, the significant improvement in muscle flexibility was noted (e.g., results for external rotation muscles: (Mean ± SD (SEM) 60.3 ± 0.4 (1.50) at baseline and 62.4 ± 10.3 (1.49) after six weeks) ( p  = 0.005). In Group 2, significant improvement was observed only for one task in the Active straight leg raise test ( p  = 0.005 and 0.02). During the measurement of external rotation muscles, a significant decrease in flexibility was observed (Mean ± SD (SEM) 60.1 ± 9.0 (1.60) at baseline and 58.0 ± 8.5 (1.51) after six weeks) ( p  = 0.001). Plantar short foot muscle exercises may improve muscle flexibility in the upper parts of the body within myofascial chains and influence the quality of fundamental movement patterns. Such exercises may be beneficial for all physically active people and can be performed as part of overall fitness programmes. Moreover, including such exercises in daily training routines of long-distance runners, as well as by athletes in other sport disciplines is also recommended.",2020,"In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks.","['Eighty long-distance runners, aged 20-45', 'amateur runners', 'Amateur Runners']","['short foot muscle exercises', 'Plantar short foot muscle exercises', 'Short Foot Muscle Exercises']","['quality of movement patterns with the Functional Movement Screen and muscle flexibility', 'total score', 'flexibility', 'Quality of Movement and Flexibility', 'external rotation muscles', 'muscle flexibility and the quality of movement patterns', 'muscle flexibility', 'Active straight leg raise test']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}]",80.0,0.0325762,"In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks.","[{'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Sulowska-Daszyk', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mika', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Oleksy', 'Affiliation': 'Physiotherapy and Sports Centre, Rzeszow University of Technology, 35-959 Rzeszow, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186534']
3171,32911776,Communicating Evidence about the Causes of Obesity and Support for Obesity Policies: Two Population-Based Survey Experiments.,"Public support for numerous obesity policies is low, which is one barrier to their implementation. One reason for this low support is the tendency to ascribe obesity to failings of willpower as opposed to the environment. Correlational evidence supports this position. However, the experimental evidence is mixed. In two experimental studies, participants were randomised to receive no message, messages about the environment's influence on obesity (Study 1 & 2), or messages about the environment's influence on human behaviour (Study 1). We investigated whether communicating these messages changed support for obesity policies and beliefs about the causes of obesity. Participants were recruited from nationally representative samples in Great Britain (Study 1 & 2) and the USA (Study 2) (total  n  = 4391). Study 2 was designed to replicate existing research. Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity. Study 2, therefore, did not replicate two earlier experimental studies. Instead, the studies reported here suggest that people's beliefs about the causes of obesity are resistant to change in response to evidence and are, therefore, not a promising avenue to increase support for obesity policies.",2020,Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity.,['Participants were recruited from nationally representative samples in Great Britain (Study 1 & 2) and the USA (Study 2) (total  n  = 4391'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],[],,0.0341881,Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity.,"[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Reynolds', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Vasiljevic', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17186539']
3172,32917784,A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).,"BACKGROUND


Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.
METHODS


To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.
RESULTS


A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m 2 ; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.
CONCLUSIONS


In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Australian Clinical Trials Registry, ACTRN12610000650099.",2020,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","['278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg', '138 participants received', 'patients with CKD who have normophosphatemia', 'mean age 63.1 years; 69% male, 64% White']","['phosphate-lowering medication', 'lanthanum carbonate or matched placebo', 'non-calcium-based phosphate binders', 'lanthanum', 'Phosphate Reduction', 'placebo']","['mean pulse wave velocity', 'abdominal aortic calcification', 'vascular calcification and arterial stiffness', 'pulse wave velocity', 'fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality', 'abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate', 'Mean serum phosphate', 'Serious adverse events', 'cardiovascular disease', 'arterial stiffness or aortic calcification', 'cardiovascular risk', 'abdominal aortic calcification and serum and urine markers of mineral metabolism', 'Mean eGFR', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0023031', 'cui_str': 'Lanthanum'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",278.0,0.574529,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","[{'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia Nigel.Toussaint@mh.org.au.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Pedagogos', 'Affiliation': 'Department of Medicine, The Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Lioufas', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Grahame J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'School of Medicine, University of Notre Dame, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': 'St. George Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Valks', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Plano, Texas.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cameron', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sylvia S M', 'Initials': 'SSM', 'LastName': 'Chen', 'Affiliation': 'Epworth Healthcare, Melbourne, Victoria, Australia.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Holt', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Concord Repatriation and General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kerr', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lai-Seong', 'Initials': 'LS', 'LastName': 'Hooi', 'Affiliation': 'Sultanah Aminah Hospital, Johor Bahru, Malaysia.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Narayan', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Angela Yee Moon', 'Initials': 'AYM', 'LastName': 'Wang', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020040411']
3173,32916855,The Potential Influence of Group Membership on Outcomes in Indicated Cognitive-Behavioral Adolescent Depression Prevention.,"BACKGROUND


Adolescent depression prevention programs are typically delivered in groups in which adolescents share a common setting and interventionist, but the influence of the group is usually ignored or statistically controlled. We tested whether the primary outcomes of reductions in depressive symptoms and future onset of major depressive disorder (MDD) varied as a function of group membership.
METHODS


Data were available from two randomized trials in which 220 adolescents received the Blues Program indicated prevention intervention in 36 separate groups; participants were assessed at baseline, post intervention, and at 6-, 12-, and 24-month follow-ups.
RESULTS


Ten percent of participants had developed MDD 2 years post intervention. Group-level effects for MDD onset over follow-up were nonsignificant (accounted for <1% of variance; ICC = 0.004, ns). Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05). Group-level clustering of posttest depressive symptoms was not associated with size of group or gender composition.
CONCLUSIONS


Membership in specific adolescent cognitive-behavioral depression prevention groups may have an impact in terms of immediate symptom reduction but does not appear to have significant prevention effects in terms of long-term symptom change or MDD onset.",2020,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).",['Data were available from two randomized trials in which 220 adolescents received the'],"['Blues Program indicated prevention intervention', 'Group Membership']","['depressive symptoms and future onset of major depressive disorder (MDD', 'depressive symptom change']","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",220.0,0.127502,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}, {'ForeName': 'Frédéric N', 'Initials': 'FN', 'LastName': 'Brière', 'Affiliation': 'École de Psychoéducation, Université de Montréal, Montreal, QC H3T 1J4, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences), Stanford University Medical Center, Stanford, CA 94305, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186553']
3174,32916983,Telemonitoring in Chronic Pain Management Using Smartphone Apps: A Randomized Controlled Trial Comparing Usual Assessment against App-Based Monitoring with and without Clinical Alarms.,"BACKGROUND


The usefulness of mHealth in helping to target face-to-face interventions for chronic pain more effectively remains unclear. In the present study, we aim to test whether the Pain Monitor mobile phone application (app) is well accepted by clinicians, and can help improve existent medical treatments for patients with chronic musculoskeletal pain. Regarding this last goal, we compared three treatment conditions, namely usual treatment, usual treatment with an app without alarms and usual treatment with an app with alarms. All treatments lasted one month. The three treatments were compared for all outcomes, i.e., pain severity and interference, fatigue, depressed mood, anxiety and anger.
METHODS


In this randomized controlled trial, the usual monitoring method (i.e., onsite;  n  = 44) was compared with daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms ( n  = 45). Alarms were sent to the clinicians in the presence of pre-established undesired clinical events and could be used to make treatment adjustments throughout the one-month study.
RESULTS


With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups). The clinicians were willing to use the app, especially the version with alarms.
CONCLUSIONS


The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.",2020,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).",['patients with chronic musculoskeletal pain'],"['daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms', 'Pain Monitor mobile phone application (app', 'Telemonitoring', 'usual treatment with an app without alarms and usual treatment with an app with alarms']","['pain severity and interference, fatigue, depressed mood, anxiety and anger']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",,0.0691226,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Department of Personality, Assessment, and Psychological Treatments, Universidad de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragozá', 'Affiliation': 'Ciber Fisiopatologia Obesidad y Nutricion (CB06/03 Instituto Salud Carlos III) (Ciber Physiopathology Obesity and Nutrition, CB06/03 Instituto Salud Carlos III Health Institute), 28029 Madrid, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Mesas', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Server', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Medel', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186568']
3175,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
3176,32921501,"Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-labeled, Multicentered, Phase IV Study.","PURPOSE


Although the role of high-intensity lipid-lowering therapy in cardiovascular protection has broadened, concerns still exist about new-onset diabetes mellitus (NODM), especially in vulnerable patients. This study aimed to compare the effect of high-dose (4 mg/d) and usual dose (2 mg/d) pitavastatin on glucose metabolism in patients with hyperlipidemia and impaired fasting glucose (IFG).
METHODS


In this 12-month study, glucose tolerance and lipid-lowering efficacy of high-dose pitavastatin (4 mg [study group]) was compared with that of usual dose pitavastatin (2 mg [control group]) in patients with hyperlipidemia and IFG. The primary end point was the change of glycosylated hemoglobin (HbA 1c ) after 24 weeks of treatment. The secondary end points were as follows: (1) NODM within 1 year after treatment, (2) change of lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels.
FINDINGS


Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG were randomly assigned into groups. The mean (SD) change in HbA 1c  was 0.06% (0.20%) in the study group and 0.03% (0.22%) in the control group (P = 0.27). Within 1 year, 27 patients (12.3%) developed NODM, including 12 (10.6%) of 113 patients in the study group and 15 (14.2%) of 106 in the control group (P = 0.43). The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01).
IMPLICATIONS


The high-dose pitavastatin therapy did not aggravate glucose metabolism compared with the usual dose therapy. Moreover, it had a better effect on cholesterol-lowering and apolipoprotein distribution in the patients with hyperlipidemia and IFG.",2020,"The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01).
","['Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG', 'Patients With Impaired Fasting Glucose and Hyperlipidemia', 'patients with hyperlipidemia and impaired fasting glucose (IFG', 'patients with hyperlipidemia and IFG']","['high-intensity lipid-lowering therapy', 'high-dose pitavastatin', 'pitavastatin', 'pitavastatin therapy', 'high-dose (4\xa0mg/d) and usual dose (2\xa0mg/d) pitavastatin', 'Pitavastatin']","['glucose tolerance and lipid-lowering efficacy', 'aggravate glucose metabolism', 'Safety and Efficacy', 'lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels', 'mean (SD) change in HbA 1c', 'glucose metabolism', 'apolipoprotein A1/apolipoprotein B ratio', 'change of glycosylated hemoglobin (HbA 1c ', 'total cholesterol and LDL-C levels', 'cholesterol-lowering and apolipoprotein distribution', 'NODM']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",313.0,0.0185979,"The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01).
","[{'ForeName': 'Hae-Young', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ki-Hoon', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Woo-Baek', 'Initials': 'WB', 'LastName': 'Chung', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Her', 'Affiliation': ""Daejeon St. Mary's Hospital, Daejeon, South Korea.""}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Dong-A University Hospital, Busan, South Korea.'}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Suwan, South Korea.'}, {'ForeName': 'Kyung-Tae', 'Initials': 'KT', 'LastName': 'Jung', 'Affiliation': 'Eulji University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Jong-Seon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Yeungnam University Hospital, Daegu, South Korea.'}, {'ForeName': 'Pum-Joon', 'Initials': 'PJ', 'LastName': 'Kim', 'Affiliation': ""St. Mary's Hospital Eunpyeong, Seoul, South Korea.""}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""St. Mary's Hospital Uijeongbu, Seoul, South Korea.""}, {'ForeName': 'Myung-Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Kyoo-Rok', 'Initials': 'KR', 'LastName': 'Han', 'Affiliation': 'Kangdong Sacred Heart Hospital, Gangdong-gu, South Korea.'}, {'ForeName': 'Jei-Keon', 'Initials': 'JK', 'LastName': 'Chae', 'Affiliation': 'Chonbuk National University Hospital, Jeollabuk-do, South Korea.'}, {'ForeName': 'Woo-Shik', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Kyung Hee University Hospital, Gangdong, South Korea.'}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul, South Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Si-Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Chungnam National University Hospital, Daejeon, South Korea.'}, {'ForeName': 'Namsik', 'Initials': 'N', 'LastName': 'Chung', 'Affiliation': 'Yonsei University Severance Hospital, Seoul, South Korea. Electronic address: namsikc@yuhs.ac.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.013']
3177,32928732,Mutations Identified in the Hepatitis C Virus (HCV) Polymerase of Patients with Chronic HCV Treated with Ribavirin Cause Resistance and Affect Viral Replication Fidelity.,"Ribavirin has been used for 25 years to treat patients with chronic hepatitis C virus (HCV) infection; however, its antiviral mechanism of action remains unclear. Here, we studied virus evolution in a subset of samples from a randomized 24-week trial of ribavirin monotherapy versus placebo in chronic HCV patients, as well as the viral resistance mechanisms of the observed ribavirin-associated mutations in cell culture. Thus, we performed next-generation sequencing of the full-length coding sequences of HCV recovered from patients at weeks 0, 12, 20, 32 and 40 and analyzed novel single nucleotide polymorphisms (SNPs), diversity, and mutation-linkage. At week 20, increased genetic diversity was observed in 5 ribavirin-treated compared to 4 placebo-treated HCV patients due to new synonymous SNPs, particularly G-to-A and C-to-U ribavirin-associated transitions. Moreover, emergence of 14 nonsynonymous SNPs in HCV nonstructural 5B (NS5B) occurred in treated patients, but not in placebo controls. Most substitutions located close to the NS5B polymerase nucleotide entry site. Linkage analysis showed that putative resistance mutations were found in the majority of genomes in ribavirin-treated patients. Identified NS5B mutations from genotype 3a patients were further introduced into the genotype 3a cell-culture-adapted DBN strain for studies in Huh7.5 cells. Specific NS5B substitutions, including DBN-D148N+I363V, DBN-A150V+I363V, and DBN-T227S+S183P, conferred resistance to ribavirin in long-term cell culture treatment, possibly by reducing the HCV polymerase error rate. In conclusion, prolonged exposure of HCV to ribavirin in chronic hepatitis C patients induces NS5B resistance mutations leading to increased polymerase fidelity, which could be one mechanism for ribavirin resistance.",2020,"At week 20, increased genetic diversity was observed in 5 ribavirin- compared to 4 placebo-treated HCV patients due to new synonymous SNPs, particularly G-to-A and C-to-U ribavirin-associated transitions.","['chronic HCV patients', 'patients with chronic hepatitis C virus (HCV) infection for 25 years', 'chronic hepatitis C patients']","['ribavirin', 'Ribavirin', 'placebo', 'ribavirin monotherapy versus placebo']","['HCV nonstructural 5B (NS5B', 'genetic diversity', 'putative resistance mutations']","[{'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",,0.0174769,"At week 20, increased genetic diversity was observed in 5 ribavirin- compared to 4 placebo-treated HCV patients due to new synonymous SNPs, particularly G-to-A and C-to-U ribavirin-associated transitions.","[{'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Mejer', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Fahnøe', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Galli', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Santseharay', 'Initials': 'S', 'LastName': 'Ramirez', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Weiland', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Dermatology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre Hospital, Hvidovre, Denmark Thomas.Lars.Benfield@regionh.dk jbukh@sund.ku.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bukh', 'Affiliation': 'Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases, Hvidovre Hospital and Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark Thomas.Lars.Benfield@regionh.dk jbukh@sund.ku.dk.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01417-20']
3178,32926227,"A phase II trial of dose-reduced nab-paclitaxel for patients with previously treated, advanced or recurrent gastric cancer (OGSG 1302).","BACKGROUND


For unresectable or recurrent advanced gastric adenocarcinoma (AGC), tri-weekly administration of nanoparticle albumin-bound paclitaxel (nab-PTX) at 260 mg/m 2  achieved a response rate of 27.8% in a phase II trial in Japan. However, frequent neutropenia and peripheral neuropathy limit its use in clinical settings. We, thus, conducted a single-arm phase II trial to investigate the efficacy and safety of a reduced dose (220 mg/m 2 ) of tri-weekly nab-PTX.
METHODS


Eligible patients included those with AGC and ECOG performance status of 0-2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens. A reduced dose of nab-PTX (220 mg/m 2 ) was administered tri-weekly. The primary endpoint was response rate (RR). Secondary endpoints were overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity (RDI) and proportion of patients receiving subsequent chemotherapy.
RESULTS


Among 33 patients enrolled, 32 were treated with protocol therapy. RR was 3.1% [95% confidence interval (CI), 0-16.2%], which did not reach the protocol-specified threshold (p = 0.966). DCR was 37.5% (95% CI, 21.1-56.3%). Median OS and PFS were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively. RDI was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy. Toxicity was relatively mild with the most common grade ≥ 3 adverse events being neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%).
CONCLUSION


Tri-weekly nab-PTX with a reduced dose (220 mg/m 2 ) is not recommended for AGC in a second-line or later setting, despite demonstrating less toxicity than at 260 mg/m 2 . Clinical trial registration The OGSG1302 trial was registered with UMIN-CTR as UMIN000000714.",2020,"Median OS and PFS were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively.","['For unresectable or recurrent advanced gastric adenocarcinoma (AGC', 'Eligible patients included those with AGC and ECOG performance status of 0-2 who had received one or more prior chemotherapy containing fluoropyrimidine regimens', '33 patients enrolled, 32 were treated with protocol therapy', 'patients with previously treated, advanced or recurrent gastric cancer (OGSG 1302']","['dose-reduced nab-paclitaxel', 'nab-PTX', 'subsequent chemotherapy', 'nanoparticle albumin-bound paclitaxel (nab-PTX']","['anorexia', 'DCR', 'efficacy and safety', 'overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity (RDI) and proportion of patients receiving subsequent chemotherapy', 'RR', 'Median OS and PFS', 'Toxicity', 'anemia', 'RDI', 'response rate (RR', 'fatigue', 'toxicity', 'peripheral neuropathy']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]",33.0,0.256661,"Median OS and PFS were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively.","[{'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryuge, Yao, Osaka, 581-0069, Japan. shigeyuki.tamura@hosp-yao.osaka.jp.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka Saiseikai Senri Hospital, Suita, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Fujita', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takeno', 'Affiliation': 'Department of Surgery, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Kindai University Hospital, Sayama, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kawada', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, 1-3-1, Ryuge, Yao, Osaka, 581-0069, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Hirao', 'Affiliation': 'Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Hirota', 'Affiliation': 'Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, Sayama, Osaka, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01768-w']
3179,32932898,Evaluation of Salivary Matrix Metalloproteinase (MMP-8) in Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil: A Randomized Clinical Trial.,"Background : Extracellular matrix metalloproteinases (MMPs) play a pivotal role in the damage to the periodontal tissue in patients with periodontitis. Scaling and root planning (SRP) attempt to control the plaque amount and consequentially reduce the bacterial load. Non-surgical periodontal treatment could be integrated with drug therapy and physiotherapy procedures such as ozone therapy. The aim of this study was to evaluate in a cohort of patients with a diagnosis of periodontitis: (1) the efficacy of non-surgical periodontal therapy assisted by the use of ozonated olive oil-based mouthwash on salivary metalloproteinase (MMP-8) and (2) the reduction of periodontal indices.  Methods : Ninety-six subjects with a diagnosis of periodontitis were enrolled in this study and randomly assigned to the study group (SRP + mouthwash) or control group (SRP). The study duration was 3 months. Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's  t -test for independent samples.  Results:  A significant improvement in PI, BoP, PPD and salivary MMP-8 levels was observed in both groups. An analysis of differences in relative changes of indices revealed the efficacy of ozonated olive oil in decreasing MMP-8 level. Simultaneously, it slowed the decrease of BoP index.  Conclusions:  Scaling and root plaining with the aid of ozonated olive oil mouthwash were found to be more effective on salivary MMP-8 reduction than scaling and root plaining alone.",2020,"Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months).","['patients with periodontitis', 'Periodontal Patients Undergoing Non-Surgical Periodontal Therapy and Mouthwash Based on Ozonated Olive Oil', 'patients with a diagnosis of periodontitis', 'Ninety-six subjects with a diagnosis of periodontitis']","['study group (SRP + mouthwash) or control group (SRP', 'ozonated olive oil-based mouthwash', 'ozonated olive oil', 'Scaling and root planning (SRP', 'Salivary Matrix Metalloproteinase (MMP-8', ' ']","['salivary MMP-8 reduction', 'PI, BoP, PPD and salivary', 'MMP-8 level', 'BoP index', 'MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD', 'MMP-8 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",96.0,0.033528,"Data on MMP-8, plaque index (PI), bleeding on probing (BoP) and probing pocket depth (PPD) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months).","[{'ForeName': 'Gianna Maria', 'Initials': 'GM', 'LastName': 'Nardi', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cesarano', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Papa', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Chiavistelli', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Ardan', 'Affiliation': 'Chair of Econometrics, Department of Economic Sciences, Koszalin University of Technology, 75-343 Koszalin, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Jedlinski', 'Affiliation': 'Department of Interdisciplinary Dentistry, Pomeranian Medical University in Szczecin, 70-111 Szczecin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mazur', 'Affiliation': 'Department of Dental and Maxillofacial Sciences, Sapienza University of Rome, 00161 Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grassi', 'Affiliation': 'Department of Biomedical Sciences, University of Sassari, 07100 Sassari, Italy.'}, {'ForeName': 'Felice Roberto', 'Initials': 'FR', 'LastName': 'Grassi', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, Aldo Moro University of Bari, 70122 Bari, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17186619']
3180,32933124,Are Respiratory Responses to Cold Air Exercise Different in Females Compared to Males? Implications for Exercise in Cold Air Environments.,"Research has shown that cold air exercise causes significant respiratory dysfunction, especially in female athletes. However, how female and male athletes respond to cold air exercise is not known. Thus, we aimed to compare acute respiratory responses (function, recovery and symptoms) in males and females after high-intensity cold air exercise. Eighteen (nine female) athletes completed two environmental chamber running trials at 0 °C and -20 °C (humidity 34 ± 5%) on different days in a randomized starting order. Spirometry was performed pre, 3, 6, 10, 15 and 20 min post. Respiratory symptoms were measured posttrial and heart rate and rating of perceived exertion were assessed during each trial. No significant differences in delta change (pre to post) were found at either temperature between sexes for FEV 1 , FVC, FEF50% and FEF25-75%. At -20 °C, FEV 1  decreased similarly in both sexes (males: 7.5%, females: 6.3%) but not at 0 °C,  p  = 0.003. Postexertion respiratory function recovery and reported symptoms were not different between sexes at either temperature. These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise. However, intense exercise at -20 °C is challenging to the respiratory system in both sexes and may lead to altered respiratory responses compared to mild winter conditions like 0 °C.",2020,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","['Eighteen (nine female) athletes completed two environmental chamber running trials at 0', 'males and females after high-intensity cold air exercise', 'female and male athletes', 'female athletes']",['cold air exercise'],"['acute respiratory responses (function, recovery and symptoms) to cold air exercise', 'delta change', 'acute respiratory responses (function, recovery and symptoms', 'posttrial and heart rate and rating of perceived exertion']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004179', 'cui_str': 'Atmosphere Exposure Chambers'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0448314,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, AB T6G 2H9, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lenz', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Faulhaber', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17186662']
3181,32958203,Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial.,"BACKGROUND


The perfusion index (PI), calculated from the photoplethysmographic waveform, reflects peripheral vasomotor tone. As such, the PI serves as a surrogate for quantitative measures of drug-induced vasoconstriction or vasodilation. This study aimed to compare the effect on the PI of desflurane and sevoflurane at equi-anaesthetic concentrations in patients undergoing single-agent inhalation anaesthesia, where equi-anaesthetic dose was based on the known minimum alveolar concentration of these agents.
METHODS


We randomly allocated patients scheduled for arthroscopic knee surgery to receive either desflurane or sevoflurane general anaesthesia after target-controlled induction of anaesthesia with propofol. Anaesthesia was maintained at age-corrected minimum alveolar concentration 1.0, under neuromuscular block (rocuronium). The PI and haemodynamic data were recorded every minute for 35 min after induction of anaesthesia and after standardised nociceptive stimulation. The primary outcome was PI, compared between the groups over time (repeated-measures analysis of variance). Secondary outcomes included MAP and HR.
RESULTS


Sixty-nine participants (mean [range] age: 42 yr [19-65 yr]; 49% females) were assigned to either desflurane (n=34) or sevoflurane (n=35). The PI remained higher under desflurane compared with sevoflurane, both before (mean difference [MD]: 3.3; 95% confidence intervals [CIs]: 2.0-4.7; P<0.001) and after tetanic stimulation (MD: 2.8; 95% CI: 2.0-3.7; P<0.001). Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22). HR was similar throughout.
CONCLUSIONS


These findings suggest that at equipotent doses, desflurane exerts more potent vasodilatory properties and lowers blood pressure by a magnitude potentially associated with harm.
CLINICAL TRIAL REGISTRATION


NCT03570164.",2020,"Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22).","['patients undergoing single-agent inhalation anaesthesia', 'Sixty-nine participants (mean [range] age: 42 yr [19-65 yr]; 49% females']","['arthroscopic knee surgery', 'desflurane and sevoflurane', 'propofol', 'desflurane or sevoflurane general anaesthesia', 'desflurane anaesthesia', 'desflurane', 'sevoflurane']","['PI and haemodynamic data', 'MAP and HR', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.368602,"Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22).","[{'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Ha', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: hoho4321.lee@daum.net.'}, {'ForeName': 'Jae-Hoon', 'Initials': 'JH', 'LastName': 'Byun', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.050']
3182,32958718,"A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19.","Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 1:1 ratio to early or late favipiravir therapy (in the latter case, the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76 to 2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, times to defervescence were 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95% CI, 0.81 to 4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by reverse transcription-PCR (RT-PCR) by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred in any of the patients in either treatment group during the 28-day participation. (This study has been registered with the Japan Registry of Clinical Trials under number jRCTs041190120.).",2020,Favipiravir did not significantly improve viral clearance as measured by RT-PCR by day 6 but was associated with numerical reduction in time to defervescence.,"['COVID-19 at 25 hospitals across Japan', 'influenza in Japan', 'Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', '30 patients who had a fever (≥37.5°C) on day 1', 'Eighty-nine patients were enrolled, of whom 69 were virologically evaluable', 'hospitalized patients with COVID-19']","['favipiravir', 'Favipiravir', 'late favipiravir therapy']","['transient hyperuricemia', 'viral clearance', 'time to defervescence and resolution of symptoms', 'Viral clearance', 'time to defervescence', 'change in viral load', 'disease progression nor death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",89.0,0.103757,Favipiravir did not significantly improve viral clearance as measured by RT-PCR by day 6 but was associated with numerical reduction in time to defervescence.,"[{'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Departments of Microbiology and Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Aichi, Japan yoheidoi@fujita-hu.ac.jp.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Hibino', 'Affiliation': 'Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Hase', 'Affiliation': 'Departments of Microbiology and Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Respiratory Medicine, Sagamihara Kyodo Hospital, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kasamatsu', 'Affiliation': 'Infection Control and Clinical Laboratory, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University Bantane Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Mutoh', 'Affiliation': 'Department of Infectious Diseases, Tosei General Hospital, Seto, Aichi, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Homma', 'Affiliation': 'Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Terada', 'Affiliation': 'Department of Respiratory Medicine, Saiseikai Niigata Hospital, Niigata, Niigata, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Center for Infectious Diseases, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Kashizaki', 'Affiliation': 'Department of Respiratory Medicine, Isehara Kyodo Hospital, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Koba', 'Affiliation': 'Department of Respiratory Medicine, Komatsu Municipal Hospital, Komatsu, Ishikawa, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kasahara', 'Affiliation': 'Department of Rheumatology, NTT East Sapporo Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Yokota', 'Affiliation': 'Department of Infectious Diseases, Tokyo Metropolitan Health and Medical Corporation Ebara Hospital, Ohta, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Infection Prevention and Control Department, Yokohama City University Hospital, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yoshida', 'Affiliation': 'Department of Chest Surgery, Shimonoseki City Hospital, Shimonoseki, Yamaguchi, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Department of Infectious Diseases, International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kamio', 'Affiliation': 'Department of Intensive Care, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kodama', 'Affiliation': 'Department of General Internal Medicine, Fukuoka Tokushukai Hospital, Kasuga, Fukuoka, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Department of General Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Department of General Internal Medicine, Eiju General Hospital, Taito, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Shinagawa Hospital, Shinagawa, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nakatsumi', 'Affiliation': 'Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Horiguchi', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsunaga', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Regenerative Medicine and Stem Cell Biology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Sumi', 'Initials': 'S', 'LastName': 'Banno', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Takenao', 'Initials': 'T', 'LastName': 'Koseki', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Teramachi', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Tajima', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Maeki', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Nakayama', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Chang Kweng', 'Initials': 'CK', 'LastName': 'Lim', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Saijo', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Kabata', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Yuzawa', 'Affiliation': 'Department of Nephrology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01897-20']
3183,32959548,[Application of three-in-one intelligent screening in outpatient department of children's hospital during COVID-19 epidemic].,"OBJECTIVE


To evaluate the application of three-in-one intelligent screening in outpatient pre-inspection in children's hospital.
METHODS


We randomly enrolled 100 children pre-screened by traditional method in the outpatient department of Children's Hospital of Zhejiang University from February 6th to 16th, 2020, and another 100 children by the intelligent three-in-one mode from February 17th to 27th, 2020. The traditional triage was conducted by nurses based on face-to-face, one-by-one interview of the epidemiological history and consultation department, and the temperature was measured before manual triage. The intelligent three-in-one model combined online rapid pre-inspection and triage, on-site manual confirmation, as well as synchronized online health education system. For on-line registered patients, the system automatically sent the COVID-19 epidemiological pre-screening triage questionnaire one hour before the appointment, requiring parents to complete and submit online before arriving at the hospital. The on-site registered patients were controlled at 100 m away from the hospital entrance. The nurses guided the parents to scan the QR code and fill in the COVID-19 epidemiological pre-examination triage questionnaire. At the entrance of the hospital, the nurse checked the guidance sheet and took the temperature again. The children with red guidance sheet were checked again and confirmed by pre-examination nurses, and accompanied to the isolation clinic through COVID-19 patients-only entrance. The children with yellow guidance sheet were guided to fever clinic. The children with green guidance sheet could go with their parents to the designated area, and then went to the corresponding consultation area. Health education was carried out throughout the treatment, and the system automatically posted the corresponding outpatient instructions and education courses. Parents would read the courses on their mobile phones and counsel online. The time of pre-examination and the coincidence rate of triage were compared between the two groups.
RESULTS


The three-in-one intelligent pre-inspection mode took an average of (25.6±8.0) s for each child, which was significantly shorter than the traditional pre-inspection mode (74.8±36.4) s ( t =13.182,  P <0.01). The triage coincidence rate of the intelligent pre-inspection model was 98%, which was similar to that of traditional model (97%,  χ 2 =0.251,  P >0.05).
CONCLUSIONS


The three-in-one intelligent pre-inspection model can effectively shorten the patient pre-check time, with similar triage coincidence rate to traditional model.",2020,"The triage coincidence rate of the intelligent pre-inspection model was 98%, which was similar to that of traditional model (97%,  χ 2 =0.251,  P >0.05).
","[""100 children pre-screened by traditional in the outpatient department of Children's Hospital Zhejiang University School of Medicine from February 6th to 16th, 2020, and another 100 children by the intelligent three-in-one mode from February 17th to 27th, 2020"", ""outpatient department of children's hospital during the COVID-19 epidemic""]",[],"['triage coincidence rate', 'time of pre-examination and the coincidence rate of triage']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}]",[],"[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",100.0,0.0214723,"The triage coincidence rate of the intelligent pre-inspection model was 98%, which was similar to that of traditional model (97%,  χ 2 =0.251,  P >0.05).
","[{'ForeName': 'Meiping', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Cangcang', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'Zhejiang GooCan Information Technology Co., Ltd., Hangzhou 310052, China.'}, {'ForeName': 'Tianlin', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}]",Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences,['10.3785/j.issn.1008-9292.2020.08.09']
3184,32865380,Colchicine in Patients with Chronic Coronary Disease.,"BACKGROUND


Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.
METHODS


In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.
RESULTS


A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).
CONCLUSIONS


In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo. (Funded by the National Health Medical Research Council of Australia and others; LoDoCo2 Australian New Zealand Clinical Trials Registry number, ACTRN12614000093684.).",2020,"A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007).","['patients with chronic coronary disease to receive 0.5 mg of', 'Patients with Chronic Coronary Disease', 'patients with recent myocardial infarction', 'patients with chronic coronary disease', '5522 patients underwent randomization; 2762']","['colchicine once daily or matching placebo', 'colchicine', 'Colchicine', 'placebo']","['composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke', 'incidence of death from noncardiovascular causes', 'risk of cardiovascular events', 'median duration', 'incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction', 'composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0444930', 'cui_str': 'End'}]",5522.0,0.707454,"A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007).","[{'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Nidorf', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Aernoud T L', 'Initials': 'ATL', 'LastName': 'Fiolet', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Mosterd', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Schut', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Tjerk S J', 'Initials': 'TSJ', 'LastName': 'Opstal', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Salem H K', 'Initials': 'SHK', 'LastName': 'The', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Xiao-Fang', 'Initials': 'XF', 'LastName': 'Xu', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ireland', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Lenderink', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Latchem', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Hoogslag', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Anastazia', 'Initials': 'A', 'LastName': 'Jerzewski', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nierop', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Whelan', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Hendriks', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Swart', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Aaf F M', 'Initials': 'AFM', 'LastName': 'Kuijper', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Maarten W J', 'Initials': 'MWJ', 'LastName': 'van Hessen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Pradyot', 'Initials': 'P', 'LastName': 'Saklani', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Tan', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Thompson', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Judkins', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bax', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'Dirksen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Charley A', 'Initials': 'CA', 'LastName': 'Budgeon', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Thompson', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021372']
3185,32908159,"Comparing the visual outcome, visual quality, and satisfaction among three types of multi-focal intraocular lenses.","This study compared the visual outcome, visual quality, and satisfaction following implantation of the Mix-and-Match bifocal IOLs (+ 2.75 D and + 3.25 D add power Tecnis Multifocal Model), EDOF IOL (Tecnis Symfony IOL), and Trifocal IOL (FineVision PodFT, PhysIOL). All outcomes were compared among the three groups. The manifest refraction indicated that the EDOF group had significantly higher myopic spherical equivalent values than did the others. In the terms of visual acuity, there were no significant differences in far or intermediate visual acuity among the three groups. Only in near (33 cm), the EDOF group had significantly worse binocular visual acuity than did the Trifocal group (p = 0.002). Regarding to defocus curve, the Trifocal group had better defocus curves at near distances (- 2.0 to - 3.5 D; p = 0.001 vs. EDOF) than did the other two groups. In contrast sensitivity test, the EDOF group had relatively lower value than did the other two groups. In reading speed, only at 0.3 logMAR (6.5-point font), Mix-and-Match group had a significantly higher reading speed than did the other two groups (p =  < 0.001 vs. EDOF, p = 0.007 vs. Trifocal). also Mix-and-Match group showed significantly fewer visual artifacts. There were no differences between the three groups in terms of patient satisfaction.ClinicalTrials.gov number: NCT04019691.",2020,There were no differences between the three groups in terms of patient satisfaction.,[],['EDOF'],"['intermediate visual acuity', 'power Tecnis Multifocal Model), EDOF IOL (Tecnis Symfony IOL), and Trifocal IOL (FineVision PodFT, PhysIOL', 'visual outcome, visual quality, and satisfaction', 'reading speed', 'patient satisfaction', 'myopic spherical equivalent values', 'visual acuity', 'visual artifacts', 'binocular visual acuity', 'visual outcome, visual quality, and satisfaction following implantation of the Mix-and-Match bifocal IOLs', 'manifest refraction']",[],[],"[{'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}]",,0.0338072,There were no differences between the three groups in terms of patient satisfaction.,"[{'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Paik', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Sang', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, The Graduate School, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Min', 'Initials': 'CM', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Hui', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea. ldhlse@gmail.com.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea. tychung@skku.edu.'}]",Scientific reports,['10.1038/s41598-020-69318-y']
3186,32908173,Effectiveness and moderators of individual cognitive behavioral therapy versus treatment as usual in clinically depressed adolescents: a randomized controlled trial.,"We examined if manualized cognitive behavioral therapy (CBT) was more effective than Treatment As Usual (TAU) for clinically depressed adolescents within routine care. This multisite Randomized controlled trail included 88 clinically depressed adolescents (aged 12-21 years) randomly assigned to CBT or TAU. Multiple assessments (pre-, post treatment and six-month follow-up) were done using semi-structured interviews, questionnaires and ratings and multiple informants. The primary outcome was depressive or dysthymic disorder based on the KSADS. Completers, CBT (n = 19) and TAU (n = 26), showed a significant reduction of affective diagnoses at post treatment (76% versus 76%) and after six months (90% versus 79%). Intention-to-treat analyses on depressive symptoms showed that 41.6% within CBT and 31.8% within the TAU condition was below clinical cut-off at post treatment and after six-months, respectively 61.4% and 47.7%. No significant differences in self-reported depressive symptoms between CBT and TAU were found. No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression. We conclude that CBT did not outperform TAU in clinical practice in the Netherlands. Both treatments were found to be suitable to treat clinically referred depressed adolescents. CBT needs further improvement to decrease symptom levels below the clinical cut-off at post treatment.",2020,"No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression.","['clinically depressed adolescents', 'clinically depressed adolescents within routine care', '88 clinically depressed adolescents (aged 12-21\xa0years']","['CBT', 'manualized cognitive behavioral therapy (CBT', 'individual cognitive behavioral therapy', 'CBT or TAU']","['self-reported depressive symptoms', 'affective diagnoses', 'depressive or dysthymic disorder based on the KSADS', 'depressive symptoms', 'symptom levels']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",88.0,0.0542196,"No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Stikkelbroek', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands. y.stikkelbroek@uu.nl.'}, {'ForeName': 'Gerko', 'Initials': 'G', 'LastName': 'Vink', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands.'}, {'ForeName': 'Maaike H', 'Initials': 'MH', 'LastName': 'Nauta', 'Affiliation': 'Faculty of Behavioral and Social Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Bottelier', 'Affiliation': 'Center for Child and Youth Psychiatry, Triversum, The Netherlands.'}, {'ForeName': 'Leonieke J J', 'Initials': 'LJJ', 'LastName': 'Vet', 'Affiliation': 'Child Study Center, Accare, The Netherlands.'}, {'ForeName': 'Cathelijne M', 'Initials': 'CM', 'LastName': 'Lont', 'Affiliation': 'Child and Youth Psychiatry, Altrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Anneloes L', 'Initials': 'AL', 'LastName': 'van Baar', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands.'}, {'ForeName': 'Denise H M', 'Initials': 'DHM', 'LastName': 'Bodden', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-71160-1']
3187,32910434,Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study.,"BACKGROUND


Guselkumab effectively treats moderate-to-severe psoriasis.
OBJECTIVES


Results of continuous guselkumab treatment through 4 years from VOYAGE 2 are presented.
METHODS


At baseline, 992 patients were randomized to receive guselkumab 100 mg every 8 weeks, placebo, or adalimumab 40 mg every 2 weeks. Placebo-treated patients crossed over to guselkumab at week 16. Weeks 28-76 incorporated randomized withdrawal, and all patients received open-label guselkumab through to week 204. Efficacy was analyzed using pre-specified treatment failure rules (patients were considered nonresponders after discontinuing due to lack of efficacy, worsening of psoriasis, or use of a prohibited treatment). There was no missing data imputation after treatment failure rules. Safety was analyzed through 4 years.
RESULTS


The proportions of guselkumab-treated patients who achieved and maintained designated clinical responses at weeks 100 and 204, respectively, were as follows: at least a 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75): 94.1% and 92.3%; PASI 90: 79.1% and 79.7%; PASI 100: 48.4% and 51.0%; Investigator's Global Assessment (IGA) score of 0/1: 83.1% and 81.9%; IGA score of 0: 52.7% and 52.7%; Dermatology Life Quality Index score of 0/1: 70.2% and 69.1%; Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0: 35.7% and 39.7%; PSSD sign score of 0: 22.0% and 27.2%; ≥ 5% improvement in Short Form-36 (SF-36) physical component score: 48.8% and 45.0%; ≥ 5% improvement in SF-36 mental component score: 45.1% and 43.2%; Hospital Anxiety and Depression Score (HADS)-anxiety score ≥ 8: 22.9% and 21.7%; and HADS-depression score ≥ 8: 16.6% and 21.0%. Similar findings were reported for the adalimumab → guselkumab group. No new safety signals were identified.
CONCLUSIONS


High efficacy levels were maintained from week 100 through to week 204 with continuous guselkumab treatment, across multiple endpoints, in VOYAGE 2. Guselkumab was well tolerated.
CLINICAL TRIAL REGISTRATION


NCT02207244.",2020,"No new safety signals were identified.
",['992 patients'],"['open-label guselkumab', 'Placebo', 'guselkumab 100\xa0mg every 8\xa0weeks, placebo, or adalimumab']","['Safety', 'Hospital Anxiety and Depression Score', 'Psoriasis Symptoms and Signs Diary (PSSD) symptom score', 'Psoriasis Area and Severity Index', ""Investigator's Global Assessment (IGA) score"", 'Efficacy', 'SF-36 mental component score', 'tolerated', 'Dermatology Life Quality Index score', 'Short Form-36 (SF-36) physical component score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}]",992.0,0.113398,"No new safety signals were identified.
","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. kreich@jerucon.com.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""Department of Medicine, The University of Melbourne, St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, Carlton, VIC, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Global Services, LLC, Malvern, PA, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00555-7']
3188,32911433,Rationale and methods of the Advanced R 2 Eperfusion STrategies for Refractory Cardiac Arrest (ARREST) trial.,"BACKGROUND


Venoarterial extracorporeal membrane oxygenation has emerged as a prominent therapy for patients with refractory cardiac arrest. However, the optimal time of initiation remains unknown.
AIM


The aim was to assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention, when needed, or (2) standard advanced cardiac life support resuscitation.
DESIGN


Phase II, single-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial.
POPULATION


Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30 minutes.
SETTING


Hospital-based.
OUTCOMES


Primary: survival to hospital discharge. Secondary: safety, survival, and functional assessment at hospital discharge and 3 and 6 months, and cost.
SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
CONCLUSIONS


The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation, informing broader implementation and a definitive Phase III clinical trial.",2020,"SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
","['Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30\u202fminutes', 'adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early', 'patients with refractory cardiac arrest', 'Hospital-based']","['venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention', 'extracorporeal cardiopulmonary resuscitation']","['rate of survival to hospital discharge', 'survival to hospital discharge', 'success rates', 'safety, survival, and functional assessment at hospital discharge and 3 and 6\u202fmonths, and cost']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0183001', 'cui_str': 'Cardiopulmonary resuscitator'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",174.0,0.0924829,"SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
","[{'ForeName': 'Demetris', 'Initials': 'D', 'LastName': 'Yannopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN. Electronic address: yanno001@umn.edu.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Kalra', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Kosmopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Walser', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Bartos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.'}]",American heart journal,['10.1016/j.ahj.2020.07.006']
3189,32912627,Randomized clinical trial comparing of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in knee osteoarthritis.,"BACKGROUND


Due to the limitations of pharmacological and surgical management of knee osteoarthritis (OA), several non-pharmacologic approaches including transcutaneous electrical nerve stimulation (TENS) and transcranial direct current stimulation (tDCS) have been introduced, with promising results.
OBJECTIVE


We aimed to investigate and compare the therapeutic effects of TENS and tDCS for the treatment of patients with knee OA.
METHODS


In this double-blinded randomized controlled trial, a total of 40 adult patients with knee OA were randomly allocated to either the TENS or the tDCS group. Patients in either group received 6 sessions of the TENS or tDCS for 2 weeks. Knee strengthening exercises were performed twice daily for the entire treatment period. Patients were evaluated using the visual analogue scale (VAS) and Western Ontario and McMaster Universities (WOMAC).
RESULTS


Significant improvement was observed in all outcomes in both TENS and tDCS groups at each follow up compared to baseline although the early improvement (first follow-up) in the WOMAC index was not significant in the TENS group. Based on the within-subject analysis, the behavior of two treatment groups did not differ regarding the changes in the course of the VAS, WOMAC score and its subscales, i.e. stiffness, pain and function (p = 0.263, 0.051, 0.198, 0.075, and 0.146, respectively).
CONCLUSIONS


Based on the results of this study, the effect of tDCS and TENS was not significantly different on pain and function of patients with knee OA.",2020,"Based on the within-subject analysis, the behavior of two treatment groups did not differ regarding the changes in the course of the VAS, WOMAC score and its subscales, i.e. stiffness, pain and function (p = 0.263, 0.051, 0.198, 0.075, and 0.146, respectively).
","['knee osteoarthritis (OA', 'knee osteoarthritis', '40 adult patients with knee OA', 'patients with knee OA']","['TENS or tDCS', 'transcutaneous electrical nerve stimulation (TENS) and transcranial direct current stimulation (tDCS', 'TENS or the tDCS', 'Knee strengthening exercises', 'transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS', 'TENS and tDCS', 'tDCS and TENS', 'TENS']","['visual analogue scale (VAS) and Western Ontario and McMaster Universities (WOMAC', 'WOMAC index', 'pain and function', 'VAS, WOMAC score and its subscales, i.e. stiffness, pain and function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",40.0,0.0348402,"Based on the within-subject analysis, the behavior of two treatment groups did not differ regarding the changes in the course of the VAS, WOMAC score and its subscales, i.e. stiffness, pain and function (p = 0.263, 0.051, 0.198, 0.075, and 0.146, respectively).
","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Sajadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forogh', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Raissi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Forugh', 'Initials': 'F', 'LastName': 'Zarnegar', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Ahadi.t@iums.ac.ir.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.08.005']
3190,32916606,"High-Sensitivity Cardiac Troponin-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): Rationale and design for a multicenter, stepped-wedge, cluster-randomized trial.","Despite evidence that high-sensitivity cardiac troponin (hs-cTn) levels in women are lower than in men, a single threshold based on the 99th percentile upper reference limit of the overall reference population is commonly used to diagnose myocardial infarction in clinical practice. This trial aims to determine whether the use of a lower female-specific hs-cTn threshold would improve the diagnosis, treatment, and outcomes of women presenting to the emergency department with symptoms suggestive of myocardial ischemia. METHODS/DESIGN: CODE-MI (hs-cTn-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women) is a multicenter, stepped-wedge, cluster-randomized trial of 30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital. All adults (≥20 years of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion. Over five, 5-month intervals, hospitals will be randomized to implement lower female hs-cTn thresholds according to the assay being used at each site. Men will continue to be assessed using the overall thresholds throughout. Women with a peak hs-cTn value between the female-specific and the overall thresholds will form our primary cohort. The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models. The cohort and outcomes will be obtained from routinely collected administrative data. The trial is designed to detect a 20% relative risk difference in the primary outcome, or a 2.2% absolute difference, with 82% power. CONCLUSIONS: This pragmatic trial will assess whether adopting lower female hs-cTn thresholds leads to appropriate assessment of women with symptoms suggestive of myocardial infarction, thereby improving treatment and outcomes.",2020,"The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models.","['30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital', 'women presenting to the emergency department with symptoms suggestive of myocardial ischemia', 'women with symptoms suggestive of myocardial infarction', 'Women (CODE-MI', 'All adults (≥20\u202fyears of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion']",[],"['CODE-MI', '1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",30.0,0.331621,"The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models.","[{'ForeName': 'Yinshan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Izadnegahdar', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'May K', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kavsak', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scheuermeyer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""Division of Cardiovascular, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada; Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Norris', 'Affiliation': 'Faculty of Nursing and Division of Cardiovascular Surgery, University of Alberta, Edmonton, Alberta, Canada; Cardiovascular Health and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Lyon', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pilote', 'Affiliation': 'Divisions of General Internal Medicine and Clinical Epidemiology, Department of Medicine, Research Institute of the McGill University Health Centre and McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jafna', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Division of Cardiovascular Surgery, New Brunswick Heart Centre, Dalhousie University, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Rychtera', 'Affiliation': 'Patient Partners, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Patient Partners, Vernon, British Columbia, Canada.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science and Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Humphries', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: karin.humphries@ubc.ca.'}]",American heart journal,['10.1016/j.ahj.2020.06.013']
3191,32919405,Methylphenidate boosts choices of mental labor over leisure depending on striatal dopamine synthesis capacity.,"The cognitive enhancing effects of methylphenidate are well established, but the mechanisms remain unclear. We recently demonstrated that methylphenidate boosts cognitive motivation by enhancing the weight on the benefits of a cognitive task in a manner that depended on striatal dopamine. Here, we considered the complementary hypothesis that methylphenidate might also act by changing the weight on the opportunity cost of a cognitive task, that is, the cost of foregoing alternative opportunity. To this end, 50 healthy participants (25 women) completed a novel cognitive effort-discounting task that required choices between task and leisure. They were tested on methylphenidate, placebo, as well as the selective D2-receptor agent sulpiride, the latter to strengthen inference about dopamine receptor selectivity of methylphenidate's effects. Furthermore, they also underwent an [ 18 F]DOPA PET scan to quantify striatal dopamine synthesis capacity. Methylphenidate boosted choices of cognitive effort over leisure across the group, and this effect was greatest in participants with more striatal dopamine synthesis capacity. The effects of sulpiride did not reach significance. This study strengthens the motivational account of methylphenidate's effects on cognition, and suggests that methylphenidate reduces the cost of mental labor by increasing striatal dopamine.",2020,The effects of sulpiride did not reach significance.,"['50 healthy participants (25 women', 'participants with more striatal dopamine synthesis capacity']","['redo option (methylphenidate or sulpiride minus placebo', 'novel cognitive effort-discounting task that required choices between task and leisure', 'I\u2009=\u2009""ignore', 'methylphenidate, placebo', 'Methylphenidate', 'MPH methylphenidate, SUL sulpiride, PBO placebo', 'placebo', 'methylphenidate']","['PBO placebo, MPH methylphenidate, SUL sulpiride, K i  [ 18 F]DOPA uptake', 'proportion redo choices', '2a Median absolute deviance, b median response times', 'cost of mental labor']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]",50.0,0.0996967,The effects of sulpiride did not reach significance.,"[{'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Hofmans', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands. l.hofmans@donders.ru.nl.'}, {'ForeName': 'Danae', 'Initials': 'D', 'LastName': 'Papadopetraki', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'van den Bosch', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Määttä', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Monja I', 'Initials': 'MI', 'LastName': 'Froböse', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Bram B', 'Initials': 'BB', 'LastName': 'Zandbelt', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Westbrook', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijmegen, The Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00834-1']
3192,32919407,The effects of eszopiclone on sleep spindles and memory consolidation in schizophrenia: a randomized clinical trial.,"Sleep spindles, defining oscillations of stage 2 non-rapid eye movement sleep (N2), mediate memory consolidation. Schizophrenia is characterized by reduced spindle activity that correlates with impaired sleep-dependent memory consolidation. In a small, randomized, placebo-controlled pilot study of schizophrenia, eszopiclone (Lunesta®), a nonbenzodiazepine sedative hypnotic, increased N2 spindle density (number/minute) but did not significantly improve memory. This larger double-blind crossover study that included healthy controls investigated whether eszopiclone could both increase N2 spindle density and improve memory. Twenty-six medicated schizophrenia outpatients and 29 healthy controls were randomly assigned to have a placebo or eszopiclone (3 mg) sleep visit first. Each visit involved two consecutive nights of high density polysomnography with training on the Motor Sequence Task (MST) on the second night and testing the following morning. Patients showed a widespread reduction of spindle density and, in both groups, eszopiclone increased spindle density but failed to enhance sleep-dependent procedural memory consolidation. Follow-up analyses revealed that eszopiclone also affected cortical slow oscillations: it decreased their amplitude, increased their duration, and rendered their phase locking with spindles more variable. Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation. In conclusion, sleep oscillations are promising targets for improving memory consolidation in schizophrenia, but enhancing spindles is not enough. Effective therapies also need to preserve or enhance cortical slow oscillations and their coordination with thalamic spindles, an interregional dialog that is necessary for sleep-dependent memory consolidation.",2020,"Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation.","['Twenty-six medicated schizophrenia outpatients and 29 healthy controls', 'Bottom', 'schizophrenia']","['MST', 'placebo or eszopiclone', 'placebo', 'eszopiclone', 'schizophrenia, eszopiclone (Lunesta®']","['N2 spindle density and improve memory', 'cortical slow oscillations', 'Sleep visits involved polysomnography', 'overnight MST improvement', 'sleep spindles and memory consolidation', 'Stanford Sleepiness Scale (SSS', 'spindle density', 'MST night plotted against overnight MST improvement']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1436328', 'cui_str': 'Eszopiclone'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1579761', 'cui_str': 'Lunesta'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.0911188,"Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation.","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Mylonas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bengi', 'Initials': 'B', 'LastName': 'Baran', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Demanuele', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Cox', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Tessa C', 'Initials': 'TC', 'LastName': 'Vuper', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Seicol', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Parr', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Cameron E', 'Initials': 'CE', 'LastName': 'Callahan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stickgold', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Dara S', 'Initials': 'DS', 'LastName': 'Manoach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. dara.manoach@mgh.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00833-2']
3193,32965593,"Transcranial random noise stimulation over the primary motor cortex in PD-MCI patients: a crossover, randomized, sham-controlled study.","Mild cognitive impairment (MCI) is a very common non-motor feature of Parkinson's disease (PD) and the non-amnestic single-domain is the most frequent subtype. Transcranial random noise stimulation (tRNS) is a non-invasive technique, which is capable of enhancing cortical excitability. As the main contributor to voluntary movement control, the primary motor cortex (M1) has been recently reported to be involved in higher cognitive functioning. The aim of this study is to evaluate the effects of tRNS applied over M1 in PD-MCI patients in cognitive and motor tasks. Ten PD-MCI patients, diagnosed according to the Movement Disorder Society, Level II criteria for MCI, underwent active (real) and placebo (sham) tRNS single sessions, at least 1 week apart. Patients underwent cognitive (Digit Span Forward and Backward, Digit Symbol, Visual Search, Letter Fluency, Stroop Test) and motor assessments (Unified Parkinson's Disease Rating Scale [UPDRS-ME], specific timed trials for bradykinesia, 10-m walk and Timed up and go tests) before and after each session. A significant improvement in motor ability (UPDRS-ME and lateralized scores, ps from 0.049 to 0.003) was observed after real versus sham tRNS. On the contrary, no significant differences were found in other motor tasks and cognitive assessment both after real and sham stimulations. These results confirm that tRNS is a safe and effective tool for improving motor functioning in PD-MCI. Future studies using a multisession tRNS applied over multitargeted brain areas (i.e., dorsolateral prefrontal cortex and M1) are required to clarify the role of tRNS regarding rehabilitative intervention in PD.",2020,"On the contrary, no significant differences were found in other motor tasks and cognitive assessment both after real and sham stimulations.","['PD-MCI patients', 'PD-MCI patients in cognitive and motor tasks']","['tRNS', 'placebo', 'Transcranial random noise stimulation', 'Transcranial random noise stimulation (tRNS']","['motor ability (UPDRS-ME and lateralized scores', 'motor tasks and cognitive assessment', 'Mild cognitive impairment (MCI', ""cognitive (Digit Span Forward and Backward, Digit Symbol, Visual Search, Letter Fluency, Stroop Test) and motor assessments (Unified Parkinson's Disease Rating Scale [UPDRS-ME], specific timed trials for bradykinesia, 10-m walk and Timed up and go tests""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0271377,"On the contrary, no significant differences were found in other motor tasks and cognitive assessment both after real and sham stimulations.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Monastero', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy. roberto.monastero@unipa.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Baschi', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Nicoletti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pilati', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pagano', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}, {'ForeName': 'Calogero Edoardo', 'Initials': 'CE', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zappia', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Brighina', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02255-2']
3194,32960662,Randomised clinical trial on 7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy in locally advanced cancer of the oral cavity/oropharynx.,"OBJECTIVE


To compare the efficacy and tolerance of 7-days-a-week accelerated postoperative radiotherapy (p-CAIR)  vs  postoperative radio-chemotherapy (p-RTCT).
METHODS


Between September 2007 and October 2013, 111 patients were enrolled and randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week ( n  = 57, p-CAIR) or 63 Gy in 1.8 Gy fractions 5-days-a-week with concurrent cisplatin 80-100 mg per square meter of body-surface area on days 1, 22 and 43 of the radiotherapy course (p-RTCT). It represents approximately 40% of the intended trial size, that was closed prematurely due to slowing accrual. Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled.
RESULTS


The rate of locoregional control (LRC) did not differ significantly between treatment arms ( p  = 0.18, HR = 0.56), 5 year LRC tended, however, to favour p-RTCT (81%)  vs  p-CAIR (62%). There was no difference in overall survival between treatment arms ( p  = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms. Haematological toxicity of p-RTCT was, however, considerably increased compared to p-CAIR.
CONCLUSION


Concurrent postoperative RTCT tended to improve locoregional control rate as compared to p-CAIR. This, however, did not transferred into improved overall survival. Postoperative RTCT was associated with a substantial increase in haematological toxicity that negatively affected treatment compliance in this arm.
ADVANCES IN KNOWLEDGE


To our knowledge, this is the first trial that compares accelerated radiotherapy and radio-chemotherapy in postoperative treatment for oralcavity/oropharyngeal cancer.",2020,"There was no difference in overall survival between treatment arms ( p  = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms.","['oralcavity/oropharyngeal cancer', 'locally advanced cancer of the oral cavity/oropharynx', 'Between September 2007 and', 'Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled', 'October 2013 111 patients']","['63\u2009Gy in 1.8\u2009Gy fractions 5-days-a-week with concurrent cisplatin', '7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy', 'radiotherapy and radio-chemotherapy', '7-days-a-week accelerated postoperative radiotherapy (p-CAIR)  vs  postoperative radio-chemotherapy (p-RTCT']","['locoregional control rate', 'severity of acute mucosal reactions and late reactions', 'rate of locoregional control (LRC', 'Haematological toxicity', 'haematological toxicity', 'overall survival']","[{'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0054732', 'cui_str': 'carboxyaminoimidazole ribotide'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",111.0,0.103538,"There was no difference in overall survival between treatment arms ( p  = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms.","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Misiołek', 'Affiliation': 'Department of Laryngology, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Idasiak', 'Affiliation': 'Radiotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Dębosz-Suwińska', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Jaworska', 'Affiliation': 'Department of Pathology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Wieslaw', 'Initials': 'W', 'LastName': 'Bal', 'Affiliation': 'Department of Chemotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Boguslaw', 'Initials': 'B', 'LastName': 'Maciejewski', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Miszczyk', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Składowski', 'Affiliation': 'Radiotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Suwinski', 'Affiliation': 'Radiotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}]",The British journal of radiology,['10.1259/bjr.20200288']
3195,32960669,Evaluation of a Tube Voltage-Tailored Contrast Medium Injection Protocol for Coronary CT Angiography: Results From the Prospective VOLCANIC Study.,"OBJECTIVE.  The purpose of this study was to prospectively evaluate, using software support, the feasibility and the quantitative and qualitative image quality parameters of a tube voltage-tailored contrast medium (CM) application protocol for patient-specific injection during coronary CT angiography (CCTA).  SUBJECTS AND METHODS.  In the Voltage-Based Contrast Media Adaptation in Coronary Computed Tomography Angiography (VOLCANIC-CTA) study, a single-center trial, 120 patients referred for CCTA were prospectively assigned to a tube voltage-tailored CM injection protocol. Automated tube voltage levels were selected in 10-kV intervals and ranged from 70 to 130 kV, and the iodine delivery rate (IDR) was adapted to the tube voltage level using dedicated software. The administered CM volume (370 mg I/mL) ranged from 33 mL at 70 kV (IDR, 0.7 g I/s) to 65 mL at 130 kV (IDR, 1.7 g I/s). Attenuation was measured in the aorta and coronary arteries to calculate quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales were used to evaluate overall image quality. Radiation metrics were also assessed and compared among the protocols.  RESULTS.  The mean age of the study patients was 62.5 ± 11.9 (SD) years. Image quality was rated as diagnostic in all patients. Contrast attenuation peaked at 70 kV ( p  < 0.001), whereas SNR and CNR parameters showed no significant differences between tube voltage levels ( p  ≥ 0.085). Additionally, no significant differences in subjective image quality parameters were found among the different protocols ( p  ≥ 0.139). The lowest radiation dose values were observed in the group assigned to the 70-kV protocol, which had a median radiation effective dose of 2.0 mSv ( p  < 0.001).  CONCLUSION.  The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.",2020,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"['The mean age of the study patients was 62.5 ± 11.9 (SD) years', 'Coronary CT Angiography', 'patient-specific injection during coronary CT angiography (CCTA', '120 patients referred for CCTA']","['tube voltage-tailored contrast medium (CM) application protocol', 'tube voltage-tailored CM injection protocol', 'Tube Voltage-Tailored Contrast Medium Injection Protocol']","['quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales', 'Radiation metrics', 'Image quality', 'subjective image quality parameters', 'lowest radiation dose values', 'tube voltage levels', 'iodine delivery rate (IDR']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",120.0,0.0253303,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"[{'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Dante A', 'Initials': 'DA', 'LastName': 'Giovagnoli', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Abadia', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vingiani', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Philipp L von Knebel', 'Initials': 'PLVK', 'LastName': 'Doeberitz', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Hubert E', 'Initials': 'HE', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Fischer', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Varga-Szemes', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Vogl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Carlo N', 'Initials': 'CN', 'LastName': 'De Cecco', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}]",AJR. American journal of roentgenology,['10.2214/AJR.20.22777']
3196,32960673,A preoperative radiomics model for the identification of lymph node metastasis in patients with early-stage cervical squamous cell carcinoma.,"OBJECTIVES


To develop and validate a radiomics model for preoperative identification of lymph node metastasis (LNM) in patients with early-stage cervical squamous cell carcinoma (CSCC).
METHODS


Total of 190 eligible patients were randomly divided into training ( n  = 100) and validation ( n  = 90) cohorts. Handcrafted features and deep-learning features were extracted from T2W fat suppression images. The minimum redundancy maximum relevance algorithm and LASSO regression with 10-fold cross-validation were used for key features selection. A radiomics model that incorporated the handcrafted-signature, deep-signature, and squamous cell carcinoma antigen (SCC-Ag) levels was developed by logistic regression. The model performance was assessed and validated with respect to its calibration, discrimination, and clinical usefulness.
RESULTS


Three handcrafted features and three deep-learning features were selected and used to build handcrafted- and deep-signature. The model, which incorporated the handcrafted-signature, deep-signature, and SCC-Ag, showed satisfactory calibration and discrimination in the training cohort (AUC: 0.852, 95% CI: 0.761-0.943) and the validation cohort (AUC: 0.815, 95% CI: 0.711-0.919). Decision curve analysis indicated the clinical usefulness of the radiomics model. The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training and validation cohorts.
CONCLUSION


The presented radiomics model can be used for preoperative identification of LNM in patients with early-stage CSCC. Its performance outperforms that of SCC-Ag level analysis alone.
ADVANCES IN KNOWLEDGE


A radiomics model incorporated radiomics signature and SCC-Ag levels demonstrated good performance in identifying LNM in patients with early-stage CSCC.",2020,"The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
","['patients with Early-stage cervical squamous cell carcinoma', 'Total of 190 eligible patients were randomly divided intotraining( n  = 100) andvalidation ( n  = 90) cohorts', 'patients with early-stage cervical squamous cell carcinoma (CSCC']",[],"['handcrafted-signature, deep-signature and squamous cell carcinoma antigen (SCC-Ag) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0279671', 'cui_str': 'Squamous cell carcinoma of cervix'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0075091', 'cui_str': 'Squamous cell carcinoma antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",190.0,0.027531,"The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
","[{'ForeName': 'Lifen', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}, {'ForeName': 'Huasheng', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Ruichun', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': ""Department of anesthesiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Zaiyi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}]",The British journal of radiology,['10.1259/bjr.20200358']
3197,32960684,Re: Bipolar Vaporization of the Prostate May Cause Higher Complication Rates Compared to Bipolar Loop Resection: A Randomized Prospective Trial.,,2020,,[],['Bipolar Loop Resection'],[],[],"[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",[],,0.0361977,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001268.02']
3198,32960716,Re: Effect of Water Composition and Timing of Ingestion on Urinary Lithogenic Profile in Healthy Volunteers: A Randomized Crossover Trial.,,2020,,['Healthy Volunteers'],['Water Composition and Timing of Ingestion'],['Urinary Lithogenic Profile'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",[],,0.0487953,,"[{'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Assimos', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001280.01']
3199,32960827,"Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial.","OBJECTIVES


The nutritional status of children with cystic fibrosis (CF) is associated with mortality and morbidity. Intestinal inflammation may contribute to impaired digestion, absorption, and nutrient utilization in patients with CF and oral glutathione may reduce inflammation, promoting improved nutritional status in patients with CF.
METHODS


The GROW study was a prospective, multicenter, randomized, placebo-controlled, double-blind, phase II clinical trial in pancreatic insufficient patients with CF between the ages of 2 and 10 years. Patients received reduced glutathione or placebo orally daily for 24 weeks. The primary endpoint was the difference in change in weight-for-age z-scores from baseline through week 24 between treatment groups. Secondary endpoints included other anthropometrics, serum, and fecal inflammatory markers in addition to other clinical outcomes.
RESULTS


Fifty-eight participants completed the study. No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6-month change in weight-for-age z-score (-0.08; 95% CI: -0.22 to 0.06; P = 0.25); absolute change in weight (kg) (-0.18; 95% CI: -0.55 to 0.20; P = 0.35); or absolute change in BMI kg/m (-0.06; 95% CI: -0.37 to 0.25; P = 0.69). There were no significant differences in other secondary endpoints. Overall, glutathione was safe and well tolerated.
CONCLUSIONS


Oral glutathione supplementation did not impact growth or change serum or fecal inflammatory markers in pancreatic insufficient children with CF when compared with placebo.",2020,"No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6 month change in weight-for-age z-score (-0.08; 95% CI: -0.22, 0.06; p = 0.25); absolute change in weight (kg) (-0.18; 95% CI: -0.55, 0.20; p = 0.35); or absolute change in BMI kg/m","['58 participants completed the study', 'children with cystic fibrosis (CF', 'Cystic Fibrosis', 'pancreatic insufficient children with CF', 'pancreatic insufficient patients with CF between the ages of 2-10 years']","['Oral glutathione supplementation', 'placebo', 'Oral Glutathione', 'reduced glutathione or placebo', 'Placebo']","['Overall, glutathione was safe and well tolerated', 'change in weight-for-age z-scores', 'impact growth or change serum or fecal inflammatory markers', 'anthropometrics, serum and fecal inflammatory markers in addition to other clinical outcomes', 'mortality and morbidity']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",58.0,0.571257,"No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6 month change in weight-for-age z-score (-0.08; 95% CI: -0.22, 0.06; p = 0.25); absolute change in weight (kg) (-0.18; 95% CI: -0.55, 0.20; p = 0.35); or absolute change in BMI kg/m","[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Bozic', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Goss', 'Affiliation': ""Seattle Children's Research Institute.""}, {'ForeName': 'Rabindra M', 'Initials': 'RM', 'LastName': 'Tirouvanziam', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Baines', 'Affiliation': ""Seattle Children's Research Institute.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kloster', 'Affiliation': ""Seattle Children's Research Institute.""}, {'ForeName': 'Liebe', 'Initials': 'L', 'LastName': 'Antoine', 'Affiliation': ""Seattle Children's Research Institute.""}, {'ForeName': 'Drucy', 'Initials': 'D', 'LastName': 'Borowitz', 'Affiliation': 'Cystic Fibrosis Foundation, Bethesda, MD.'}, {'ForeName': 'Sarah Jane', 'Initials': 'SJ', 'LastName': 'Schwarzenberg', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, MN.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002948']
3200,32961834,Effect of Electronic Activity Monitors and Pedometers on Health: Results from the TAME Health Pilot Randomized Pragmatic Trial.,"Background:  Brief counseling and self-monitoring with a pedometer are common practice within primary care for physical activity promotion. It is unknown how high-tech electronic activity monitors compare to pedometers within this setting. This study aimed to investigate the outcomes, through effect size estimation, of an electronic activity monitor-based intervention to increase physical activity and decrease cardiovascular disease risk.  Method:  The pilot randomized controlled trial was pre-registered online at clinicaltrials.gov (NCT02554435). Forty overweight, sedentary participants 55-74 years of age were randomized to wear a pedometer or an electronic activity monitor for 12 weeks. Physical activity was measured objectively for 7 days at baseline and follow-up by a SenseWear monitor and cardiovascular disease risk was estimated by the Framingham risk calculator.  Results:  Effect sizes for behavioral and health outcomes ranged from small to medium. While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  Conclusion:  The results of this pilot trial show promise for this low-intensity intervention strategy, but large-scale trials are needed to test its efficacy.",2020,"While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  ","['Forty overweight, sedentary participants 55-74 years of age']","['electronic activity monitor-based intervention', 'Electronic Activity Monitors and Pedometers', 'electronic activity monitor']","['physical activity (PA', 'Physical activity', 'general health', 'Health']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",40.0,0.0880024,"While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  ","[{'ForeName': 'Zakkoyya H', 'Initials': 'ZH', 'LastName': 'Lewis', 'Affiliation': 'College of Science, Department of Kinesiology and Health Promotion, California State Polytechnic University Pomona, 3801 West Temple Ave., Pomona, CA 91768, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ottenbacher', 'Affiliation': 'School of Health Professions, Division of Rehabilitation Sciences, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Steve R', 'Initials': 'SR', 'LastName': 'Fisher', 'Affiliation': 'School of Health Professions, Department of Physical Therapy, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Kristofer', 'Initials': 'K', 'LastName': 'Jennings', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, 1400 Pressler St., Unit 1411, Houston, TX 77030-4008, USA.'}, {'ForeName': 'Arleen F', 'Initials': 'AF', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of General Internal Medicine and Health Services Research, University of California Los Angeles, 1100 Glendon, Ave., Los Angeles, CA 90095, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Swartz', 'Affiliation': 'Department of Pediatrics, Division of Pediatrics, MD Anderson Cancer Center, 7777 Knight Rd., Houston, TX 77054, USA.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Lyons', 'Affiliation': 'School of Health Professions, Department of Nutrition and Metabolism, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186800']
3201,32961848,Body Image Relates to Exercise-Induced Antinociception and Mood Changes in Young Adults: A Randomized Longitudinal Exercise Intervention.,"Background:  An important motivation for adolescents and young adults to engage in aerobic exercise (AE) is to improve fitness, body composition and physical appearance. These parameters have an impact on bodily perception as conceptualized by the 'body image' (BI) construct. AE is known to have positive effects on pain perception, mood, and body image (BI). However, no study has hitherto investigated their interrelationship within one study.  Methods:  Participants were randomly assigned to an intervention group (IG,  n  = 16, 6 months of AE) or a passive control group (CG,  n  = 10). Frankfurt Body-Concept Scales (FKKS), Positive and Negative Affect Scale (PANAS), State and Trait Anxiety Inventory, warmth and heat pain thresholds (WPT, HPT), pain tolerance, and graded exercise test data from baseline (T0) and the end of the intervention (T6) were analyzed using a paired  t -test ( p  < 0.05).  Results:  A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  Conclusion:  Data in young adults undergoing AE indicate that changes in the BI sub-category 'physical efficacy' are closely linked with changes in positive affect and antinociception. These novel findings suggest that BI plays a role in antinociception and positive affect.",2020,"A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  ","['Young Adults', 'adolescents and young adults', 'young adults undergoing AE']","['aerobic exercise (AE', 'intervention group (IG,  n  = 16, 6 months of AE) or a passive control']","['Frankfurt Body-Concept Scales (FKKS), Positive and Negative Affect Scale (PANAS), State and Trait Anxiety Inventory, warmth and heat pain thresholds (WPT, HPT), pain tolerance, and graded exercise test data', ""BI dimension 'physical efficacy"", 'pain perception, mood, and body image (BI']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",,0.0351208,"A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  ","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Maurer', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Deckert', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Levenig', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44780 Bochum, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schörkmaier', 'Affiliation': 'German Center for Neurodegenerative Diseases, 53105 Bonn, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Stangier', 'Affiliation': 'German Center for Neurodegenerative Diseases, 53105 Bonn, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Attenberger', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hasenbring', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44780 Bochum, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Boecker', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17186801']
3202,32920941,Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low- and middle-income countries: study protocol of the FALCON trial.,"AIM


Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
METHOD


FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone-iodine for skin preparation, or (2) triclosan-coated suture versus non-coated suture for fascial closure, can reduce surgical site infection at 30-days post-surgery for each of (1) clean-contaminated and (2) contaminated/dirty surgery. Patients with predicted clean-contaminated or contaminated/dirty wounds with abdominal skin incision ≥ 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and noncoated suture and (4) 10% aqueous povidone-iodine and triclosan-coated suture. The two strata (clean-contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI.
CONCLUSION


FALCON will deliver high-quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.",2020,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","['5,480 patients', 'Patients with predicted clean-contaminated or contaminated/ dirty wounds with abdominal skin incision ≥5cm', 'patients in LMICs undergoing abdominal surgery', 'low- and middle-income countries']","['alcoholic chlorhexidine', 'alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, and (4) 10% aqueous povidone-iodine and triclosan-coated suture', 'povidone-iodine for skin preparation, and (2) triclosan-coated suture versus non-coated suture for fascial closure']","['SSI rates', 'SSI at 30-days, based on the Centers for Disease Control definition of SSI', 'surgical site infection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0574780', 'cui_str': 'Wound dirty'}, {'cui': 'C0222166', 'cui_str': 'Skin structure of abdomen'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",5480.0,0.323638,"SSI rates are significantly higher in low- and middle-income countries (LMICs) but there is little high-quality evidence on interventions to prevent SSI in LMICs.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15354']
3203,32921366,Percutaneous Coronary Intervention or Surgery for Unprotected Left Main Disease: EXCEL Trial at 5 Years.,"Although coronary artery bypass graft (CABG) surgery traditionally has been considered the gold standard for left main revascularization, percutaneous coronary intervention has evolved in the past decades so that it now represents a valid alternative to CABG in a large proportion of cases. The landmark Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest contemporary randomized comparison assessing the impact of revascularization strategies for left main disease. This review discusses the background, rationale, design, results, and implications of the EXCEL trial.",2020,The landmark Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest contemporary randomized comparison assessing the impact of revascularization strategies for left main disease.,[],"['Percutaneous Coronary Intervention or Surgery', 'coronary artery bypass graft (CABG) surgery', 'XIENCE versus Coronary Artery Bypass Surgery']",[],[],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]",[],,0.0604503,The landmark Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is the largest contemporary randomized comparison assessing the impact of revascularization strategies for left main disease.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Azzalini', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA. Electronic address: https://twitter.com/SportsDoc2009.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA; The Cardiovascular Research Foundation, New York, NY, USA. Electronic address: gregg.stone@mountsinai.org.'}]",Interventional cardiology clinics,['10.1016/j.iccl.2020.05.002']
3204,32923171,"Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC).","Resection of colorectal liver metastases (CRLM) is a potential curative treatment for patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD). Although long-term survival improved considerably within the last decades, high recurrence rates of 50-75% after resection remain a major challenge.Tecemotide (L-BLP25) is an antigen-specific cancer vaccine inducing immunity against mucin-1 (MUC1). The LICC trial aimed to improve survival in patients with mCRC after R0/R1 resection of CRLM. LICC was a binational, randomized, double-blind, placebo-controlled, multicenter phase 2 study including patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver. Co-primary endpoints were recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety. In total, 121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive tecemotide (N=79) or placebo (N=42). Baseline characteristics were well balanced. Median RFS was 6.1 months (95% CI 4.5-8.9) and 11.4 months (95% CI 3.7-21.2) ( P  = .1754), 3-year OS rate 69.1% and 79.1%, median OS 62.8 months and not reached in the tecemotide vs. placebo arm ( P  = .2141), respectively. Cox regression models revealed no dependence of RFS or OS on MUC1 expression. The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each). The LICC trial failed to meet its primary endpoints of significantly improving RFS and OS with tecemotide. However, both arms showed unexpectedly long OS. MUC1 expression was not associated with outcome.EudraCT No: 2011-000218-20Clinical Trial Information: NCT01462513Financial Support: Merck KGaA, Darmstadt, Germany.
Abbreviations


AE: adverse event; CP: cyclophosphamide; CRC: colorectal cancer; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; FU: follow-up; HR: hazard ratio; IHC: immunohistochemical staining; ITT: intention-to-treat; DSMB: Data Safety Monitoring Board; LLD: liver-limited disease; mCRC: metastatic colorectal cancer; MPLA: monophosphoryl lipid; AMRI: magnetic resonance imaging; MUC1: mucin 1; NA: not applicable; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NS: normal saline; NSCLC: non-small-cell lung carcinoma; OS: overall surviva; lPP: per protocol; RAS: Rat sarcoma; RFS: recurrence-free survival; TEAE: treatment-emergent adverse event; UICC: Union for International Cancer Control; US: ultrasound; vs.: versus.",2020,"The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each).","['patients with mCRC after R0/R1 resection of CRLM', 'patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver', '121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive', 'patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD', 'colorectal liver metastases', ' 2011-000218-20Clinical Trial Information']","['LICC', 'tecemotide', 'Tecemotide (L-BLP25', 'Adjuvant MUC vaccination with tecemotide', 'saline; NSCLC', 'CP: cyclophosphamide; CRC', 'placebo', 'Resection of colorectal liver metastases (CRLM', 'EudraCT']","['3-year OS rate', 'diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus', 'MUC1 expression', 'recurrence rates', 'recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety', 'Median RFS', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C1832016', 'cui_str': 'L-BLP25'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0021845', 'cui_str': 'Perforation of intestine'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0006611', 'cui_str': 'Cancer antigen 15-3'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",121.0,0.76445,"The most common tecemotide-related grade 3/4 adverse events were diarrhea, injection site reaction, intestinal perforation, peritonitis and tinnitus (1.3% each).","[{'ForeName': 'Carl Christoph', 'Initials': 'CC', 'LastName': 'Schimanski', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kasper', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Hegewisch-Becker', 'Affiliation': 'Hematological and Oncological Practice Eppendorf (HOPE), Practice for Oncology, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Practice for Hematology and Oncology, Müllheim a.d.R., Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Overkamp', 'Affiliation': 'Oncologianova GmbH Recklinghausen, Recklinghausen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Nordoberpfalz Clinics AG, Weiden i.d.O, Germany.'}, {'ForeName': 'Wolf Otto', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vöhringer', 'Affiliation': 'Department of Hematology and Oncology, Robert Bosch Hospital, Stuttgart, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Öllinger', 'Affiliation': 'Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lordick', 'Affiliation': 'University Cancer Center Leipzig (UCCL), University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Geißler', 'Affiliation': 'Department of Internal Medicine, Oncology/Hematology, Gastroenterology, Hospital Esslingen GmbH, Esslingen, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schulz-Abelius', 'Affiliation': 'Department of Hematology and Oncology, Hospital Altenburger Land GmbH, Altenburg, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Department of Hematology/Oncology, Klinikum Darmstadt GmbH, Darmstadt, Germany.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Schön', 'Affiliation': 'Clinic of Visceral Surgery, Municipal Hospital Karlsruhe gGmbH, Karlsruhe, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Department of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster, Salzburg, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Galle', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Hauke', 'Initials': 'H', 'LastName': 'Lang', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University Hospital of Mainz, Mainz, Germany.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schmidtmann', 'Affiliation': 'Institute for Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Medical Department 1, Johannes Gutenberg University, Mainz, Germany.'}]",Oncoimmunology,['10.1080/2162402X.2020.1806680']
3205,32930131,Neo-adjuvant chemotherapy followed by either continuous hyper-fractionated accelerated radiation therapy week-end less or conventional chemo-radiotherapy in locally advanced NSCLC-A randomised prospective single institute study.,"Context


Better locoregional control and increased overall survival by continuous hyper fractionated accelerated radiotherapy have been shown in unresectable nonsmall cell lung carcinoma (NSCLC). Dose escalation and neoadjuvant chemotherapy (NACT) along with continuous hyperfractionated accelerated radiotherapy week end-less (CHARTWEL) were also tried for improved survival. In this present study, we compared the results of NACT followed by CHARTWEL against NACT followed by conventional concurrent chemo-radiation therapy.
Aims


The aim of this study is to compare the locoregional control and toxicities in NSCLC Stage IIIA and B in both arms.
Settings and Design


Randomized, prospective single-institutional study with a study population comprising all locally advanced unresectable NSCLC patients enrolled in 2014 at our institute.
Subjects and Methods


All enrolled patients were randomized into two arms-CHARTWEL and concomitant chemo-radiotherapy (CCRT), after three weeks of the fourth cycle of NACT. In CHARTWEL arm 30 patients received two-dimensional radiotherapy (RT) 58.5 Gy/39 fr/2.5 weeks while in CCRT arm 30 received 66 Gy/33 fr/6.5 weeks. Disease response was evaluated at 6 months and toxicity assessment during and after treatment completion. Data were analyzed using tools such as percentage, mean, Chi-square test and P value. Chi-square and P value was calculated by statistical online software (http://quantpsy.org).
Results


28% of patients in study arm and 20% in control arm had complete response at 6 months after RT. Locoregional disease control was observed in 44% in study arm and 32% in control arm of patients. There was no statistical difference in grades of toxicities or overall survival (OS)/disease-free survival except persistent esophagitis Grade III seen in two patients of study arm.
Conclusions


Study suggests that CHARTWEL in combination with NACT is an effective strategy to treat patients with locally advanced lung cancer with the advantage of a smaller dose and shorter duration. Although large multivariate studies still needed.",2020,"There was no statistical difference in grades of toxicities or overall survival (OS)/disease-free survival except persistent esophagitis Grade III seen in two patients of study arm.
","['study population comprising all locally advanced unresectable NSCLC patients enrolled in 2014 at our institute', 'patients with locally advanced lung cancer']","['continuous hyper-fractionated accelerated radiation therapy week-end less or conventional chemo-radiotherapy', 'NACT', 'neoadjuvant chemotherapy (NACT', 'concomitant chemo-radiotherapy (CCRT', 'continuous hyper fractionated accelerated radiotherapy', 'dimensional radiotherapy (RT']","['Locoregional disease control', 'locoregional control and toxicities', 'complete response', 'grades of toxicities or overall survival', 'Disease response', 'survival', 'overall survival']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0684249', 'cui_str': 'Lung carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0753125,"There was no statistical difference in grades of toxicities or overall survival (OS)/disease-free survival except persistent esophagitis Grade III seen in two patients of study arm.
","[{'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Kumar', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Paramanandhan', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Purohit', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Jakhar', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Satynarayan', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Maharia', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}, {'ForeName': 'Rahul Kumar', 'Initials': 'RK', 'LastName': 'Rai', 'Affiliation': 'Department of Radiotherapy, Acharya Tulsi Regional Cancer Treatment and Research Institute, Sardar Patel Medical College, Bikaner, Rajasthan, India.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_377_16']
3206,32933119,Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults.,"This study examined the effects of a person-centered nursing intervention program for frailty (PNIF) targeting community-dwelling prefrail older people in South Korea. The study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index. The intervention group ( n  = 20) received group intervention sessions two days/week for twelve weeks and the control group ( n  = 20) attended lectures about frailty prevention one day/week for four weeks. The evaluation instruments included the CHS Frailty Index, a JAMAR ®  hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS). Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks. No significant between-group differences in ESSI scores were observed. The PNIF effectively improved grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty among community-dwelling older adults.",2020,"Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks.","['study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index', 'Prefrail Community-Dwelling Older Adults', 'frailty (PNIF) targeting community-dwelling prefrail older people in South Korea']","['Person-Centered Nursing Intervention', 'control group ( n  = 20) attended lectures about frailty prevention', 'person-centered nursing intervention program']","['grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty', 'SPPB', 'ESSI scores', 'right-hand grip strength', 'K-CHAMPS', 'CHS Frailty Index, a JAMAR ®  hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS', 'CHS Frailty Index', 'left-hand grip strength']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",40.0,0.0117517,"Significant differences were found in the CHS Frailty Index ( p  < 0.001), left-hand grip strength ( p  = 0.022), right-hand grip strength ( p  = 0.009), SPPB ( p  = 0.007), K-CHAMPS ( p  = 0.009), MNA ( p  = 0.018), and GDSSF-K ( p  = 0.001) between the two groups after 12 weeks.","[{'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': 'College of Nursing, Konyang University, Daejeon 35365, Korea.'}, {'ForeName': 'Yeon-Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Seoul National University, Seoul 03080, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186660']
3207,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey; Department of Physiotherapy and Rehabilitation, Faculty of Allied Medical Sciences, Arab American University, Jenin, Palestine. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
3208,32937620,The Effects of a Simulated Workday of Prolonged Sitting on Seated versus Supine Blood Pressure and Pulse Wave Velocity in Adults with Overweight/Obesity and Elevated Blood Pressure.,"We evaluated the effects of a simulated workday of prolonged sitting on blood pressure (BP) and pulse wave velocity (PWV) and examined whether posture (seated vs. supine) affected responses. Participants (n = 25) were adults, with overweight/obesity and elevated BP, and performed seated desk work for 7.5 h. BP and PWV were measured in seated and supine postures at baseline (7:15 a.m.), midday (12:05 p.m.), and afternoon (4:45 p.m.). Generalized linear mixed models evaluated the effects of prolonged sitting on BP and PWV within each posture and interactions by posture and sex. In the recommended postures, seated BP and supine carotid-femoral pulse wave velocity (cfPWV) and carotid-ankle pulse wave velocity (caPWV), but not carotid-radial pulse wave velocity (crPWV), significantly increased over the simulated seated workday (all p < 0.05; effect sizes [d] ranged from 0.25 to 0.44). Whilst no posture-by-time interactions were observed (p > 0.05), BP, caPWV, and crPWV were higher when seated versus supine (main effects of posture p < 0.05; d ranged from 0.30 to 1.04). Exploratory analysis revealed that females had greater seated BP responses (p for interaction <0.05); seated PWV and supine BP and PWV responses were similar by sex (p for interaction >0.05). A simulated workday of prolonged sitting increased seated BP and supine cfPWV and caPWV, and posture minimally influenced these responses. These results add to the evidence suggesting a deleterious effect of prolonged sitting on cardiovascular health.",2020,Exploratory analysis revealed that females had greater seated BP responses (p for interaction <0.05); seated PWV and supine BP and PWV responses were similar by sex (p for interaction >0.05).,"['Adults with Overweight/Obesity and Elevated Blood Pressure', 'Participants (n = 25) were adults, with overweight/obesity and elevated BP, and performed seated desk work for 7.5 h']","['Simulated Workday of Prolonged Sitting on Seated versus Supine Blood Pressure and Pulse Wave Velocity', 'simulated workday of prolonged sitting']","['seated PWV and supine BP and PWV responses', 'seated BP responses', 'BP and PWV', 'carotid-radial pulse wave velocity (crPWV', 'cardiovascular health', 'BP, caPWV, and crPWV', 'seated BP and supine carotid-femoral pulse wave velocity (cfPWV) and carotid-ankle pulse wave velocity (caPWV', 'blood pressure (BP) and pulse wave velocity (PWV']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0232142', 'cui_str': 'Radial pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",25.0,0.0541299,Exploratory analysis revealed that females had greater seated BP responses (p for interaction <0.05); seated PWV and supine BP and PWV responses were similar by sex (p for interaction >0.05).,"[{'ForeName': 'Abdullah Bandar', 'Initials': 'AB', 'LastName': 'Alansare', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA, aba79@pitt.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kowalsky', 'Affiliation': 'Department of Health and Kinesiology, College of Education and Human Performance, Texas A&M University-Kingsville, Kingsville, Texas, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Jones', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Sophy J', 'Initials': 'SJ', 'LastName': 'Perdomo', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Sport and Exercise, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'Department of Health and Physical Activity, College of Education, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}]",Journal of vascular research,['10.1159/000510294']
3209,32940419,"High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) improves symptoms and autonomic function for insomnia: A randomized, placebo-controlled clinical trial.","INTRODUCTION


Effective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM ®  ), in a randomized, controlled clinical trial. HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology, to support self-optimization of brain rhythms.
METHODS


One hundred and seven adults (mean age 45.7, SD ± 5.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90-min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or random tones not linked to brainwaves (NL, 51), as an active, sham placebo. Outcomes were obtained at enrollment (V1), 1-7 days (V2), 8-10 weeks (V3), and 16-18 weeks (V4) after intervention. Primary outcome was differential change in ISI from V1 to V3. Secondary measures assessed depression (BDI), anxiety (BAI), quality of life (EQ-5D), and a sleep diary. Ten minute recordings of HR and BP allowed analysis of heart rate variability (HRV) and baroreflex sensitivity (BRS).
RESULTS


Of 107 randomized, 101 completed the intervention. Intention-to-treat analysis (107) of change from V1 to V3 revealed a mean reduction of ISI in NL of -4.93 (SE ± 0.76) points, with additional, significant reduction of -2.05 points (0.74) in LB (total reduction of -6.98, p = .045). Additional reduction of -2.30 points (0.76) was still present in the LB at V4 (p = .058). Total ISI reduction from V1 to V4 was -5.90 points for NL and -7.93 points in LB. There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency. There were no serious adverse events.
CONCLUSIONS


Results of this controlled clinical trial showed clinically relevant reduction of insomnia symptoms with HIRREM, over, and above an active, sham control, with associated, durable improvement in autonomic cardiovascular regulation.",2020,"There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency.","['One hundred and seven adults (mean age 45.7, SD\xa0±\xa05.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90-min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or', 'insomnia', 'Of 107 randomized']","['placebo', 'electroencephalic mirroring (HIRREM', 'random tones not linked to brainwaves (NL, 51), as an active, sham placebo']","['differential change in ISI', 'autonomic cardiovascular regulation', 'multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency', 'heart rate variability (HRV) and baroreflex sensitivity (BRS', 'Total ISI reduction', 'depression (BDI), anxiety (BAI), quality of life (EQ-5D), and a sleep diary']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0678909', 'cui_str': 'Brainwaves'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0678909', 'cui_str': 'Brainwaves'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",107.0,0.243114,"There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency.","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Tegeler', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.'}, {'ForeName': 'Hossam A', 'Initials': 'HA', 'LastName': 'Shaltout', 'Affiliation': 'Hypertension and Vascular Research Center, WFSM, Winston-Salem, NC, USA.'}, {'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'University of Arizona School of Medicine, Phoenix, AZ, USA.'}, {'ForeName': 'Sean L', 'Initials': 'SL', 'LastName': 'Simpson', 'Affiliation': 'Department of Biostatistics and Data Sciences, WFSM, Winston-Salem, NC, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Gerdes', 'Affiliation': 'Brain State Technologies, LLC, Scottsdale, AZ, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Tegeler', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.'}]",Brain and behavior,['10.1002/brb3.1826']
3210,32942043,Rationale and design of the Medical Research Council's Precision Medicine with Zibotentan in Microvascular Angina (PRIZE) trial.,"Microvascular angina is caused by cardiac small vessel disease, and dysregulation of the endothelin system is implicated. The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1. The prevalence of this allele is higher in patients with ischemic heart disease. Zibotentan is a potent, selective inhibitor of the ET A  receptor. We have identified zibotentan as a potential disease-modifying therapy for patients with microvascular angina. METHODS: We will assess the efficacy and safety of adjunctive treatment with oral zibotentan (10 mg daily) in patients with microvascular angina and assess whether rs9349379 (minor G allele; population prevalence ~36%) acts as a theragnostic biomarker of the response to treatment with zibotentan. The PRIZE trial is a prospective, randomized, double-blind, placebo-controlled, sequential cross-over trial. The study population will be enriched to ensure a G-allele frequency of 50% for the rs9349379 SNP. The participants will receive a single-blind placebo run-in followed by treatment with either 10 mg of zibotentan daily for 12 weeks then placebo for 12 weeks, or vice versa, in random order. The primary outcome is treadmill exercise duration using the Bruce protocol. The primary analysis will assess the within-subject difference in exercise duration following treatment with zibotentan versus placebo. CONCLUSION: PRIZE invokes precision medicine in microvascular angina. Should our hypotheses be confirmed, this developmental trial will inform the rationale and design for undertaking a larger multicenter trial.",2020,"The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1.","['patients with microvascular angina', 'microvascular angina', 'patients with ischemic heart disease', 'patients with microvascular angina and assess whether rs9349379 (minor G allele; population prevalence ~36']","['placebo', 'oral zibotentan', 'zibotentan versus placebo']","['exercise duration', 'efficacy and safety', 'treadmill exercise duration using the Bruce protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0442713', 'cui_str': 'Bruce protocol'}]",,0.469459,"The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Morrow', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Kotecha', 'Affiliation': 'Royal Free Hospital, Royal Free London NHS Foundation Trust London, United Kingdom.'}, {'ForeName': 'Roby', 'Initials': 'R', 'LastName': 'Rakhit', 'Affiliation': 'Royal Free Hospital, Royal Free London NHS Foundation Trust London, United Kingdom.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Galasko', 'Affiliation': 'Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hoole', 'Affiliation': 'Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Experimental Medicine and Immunotherapeutics, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kharbanda', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom; Department of Cardiology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Ferreira', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Mayooran', 'Initials': 'M', 'LastName': 'Shanmuganathan', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Chiribiri', 'Affiliation': ""Division of Imaging Sciences, Guy's and St Thomas' Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Divaka', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Haseeb', 'Initials': 'H', 'LastName': 'Rahman', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Jayanth R', 'Initials': 'JR', 'LastName': 'Arnold', 'Affiliation': 'Department of Cardiovascular Sciences, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Liverpool University and Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Husmeier', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Hill', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Genetics, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Department of Clinical Genetics, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dempster', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Macfarlane', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alex Mc', 'Initials': 'AM', 'LastName': 'Connachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sandosh', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.'}]",American heart journal,['10.1016/j.ahj.2020.07.007']
3211,32942054,Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.,"BACKGROUND


Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.
METHODS


A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
RESULTS


The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.
CONCLUSIONS


Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03278340.",2020,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","['Departments of transportation (DOTs) from 21\u202fU.S. states are participating and their 138 regional districts', 'adults who work outdoors in the sun']","['scaling-up the Sun Safe Workplaces (SSW) intervention', 'scaling-up an occupational sun protection intervention']",[],"[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",[],,0.139656,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Research at Klein Buendel, Inc, A Health Communication and Media Development Firm, Golden, CO, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'President at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Investigator at Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Emeritus at the University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Research Program Manager at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': 'Project Coordinator at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106147']
3212,32947994,A Pilot Evaluation of a Smartphone Application for Workplace Depression.,"Interventions delivered via mobile apps show particular promise in tackling the burden of common mental disorders. Appropriately targeting these interventions to at-risk populations is critical to their success. This pilot study aimed to assess the usability, feasibility, acceptability, and preliminary effects of an app-based intervention designed to target depressive symptoms in a stressed working population. Anchored, a smartphone app including a 30-day program of mindfulness and cognitive and behavioural therapeutic components, was tested in a pre-post pilot study with participants recruited via social media advertisements. Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure. Follow-up assessment occurred 5 weeks after baseline. The primary outcome measure was change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance. User feedback and in-app data were analysed to assess engagement and intervention adherence. At follow-up, there were significant reductions in depressive symptoms (t 61  = 6.35;  p  < 0.001) and anxiety symptoms (t 60  = 7.35;  p  < 0.001), along with significantly reduced cases of likely new onset depression compared to baseline (24% vs. 6%,  p =  0.012). Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001). Participants reported no significant changes in work performance, absenteeism or exercise. There were satisfactory levels of app usability, feasibility, and acceptability. Most participants found the app easy to use (93.2%), understood the app content well (83.0%), and rated the app highly or very highly overall (72.9%). User feedback suggestions were predominantly focused on improving app navigation and user interface. This pilot study provides encouraging evidence that Anchored has potentially beneficial effects, and is usable, feasible, and acceptable as an app-based intervention for the working population experiencing elevated stress. Further testing of Anchored in a randomised controlled trial is required to investigate its efficacy as an intervention for workplace mental ill-health.",2020,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","['Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure', 'stressed working population', 'participants recruited via social media advertisements', 'Workplace Depression', 'workplace mental ill-health']",['Smartphone Application'],"['wellbeing', 'usability, feasibility, acceptability', 'anxiety symptoms', 'change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance', 'satisfactory levels of app usability, feasibility, and acceptability', 'work performance, absenteeism or exercise', 'depressive symptoms', 'new onset depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",81.0,0.281056,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","[{'ForeName': 'Daniel A J', 'Initials': 'DAJ', 'LastName': 'Collins', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Lavender', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, Faculty of Medicine and Health, University of Sydney,Sydney, NSW 2050, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186753']
3213,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND


Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS


A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS


3222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199.29/10,000 contacts/year vs. 132.13 (incidence rate ratio of 1.51 (95% CI 1.21-1.88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6360.
CONCLUSION


ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2.5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Peru; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, CA, United States. Electronic address: tbrewer@mednet.ucla.edu.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
3214,32950748,Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Mirikizumab is an antibody against the p19 subunit of interleukin 23 that has demonstrated clinical efficacy and was well tolerated following 12 weeks of induction treatment in a phase 2 trial of patients with moderate to severe ulcerative colitis. We present results of the open-label extended induction period in patients who did not initially respond to treatment with mirikizumab.
METHODS


This study was a continuation of I6T-MC-AMAC, a double-blind trial, performed at 75 sites in 14 countries, in which patients with moderate to severe ulcerative colitis were randomly assigned to 12 weeks induction therapy with 50 mg, 200 mg, or 600 mg mirikizumab or placebo. Patients without a clinical response (a 9-point decrease in Mayo subscore of ≥2 points and ≥35% from baseline and either a decrease of rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1) at week 12 were offered the opportunity to participate in an open-label, extended induction study for another 12 weeks, in which they received either 600 mg intravenous mirikizumab (n = 20) or, following a protocol amendment, 1000 mg intravenous mirikizumab (n = 64) every 4 weeks. At week 24, patients with a clinical response continued the extension maintenance period and received 200 mg subcutaneous mirikizumab. Endpoints included clinical remission (Mayo subscores of 0 for rectal bleeding, 0 or 1 with a 1-point decrease from baseline), clinical response, endoscopic remission (Mayo endoscopic subscore of 0), or endoscopic improvement (endoscopic subscore of 0 or 1), at study weeks 24 and 52. Data were analysed for patients who received mirikizumab or placebo during the induction phase of the study.
RESULTS


Among participants who did not respond to induction mirikizumab, 50.0% of those who received the 12-week extension of 600 mg mirikizumab and 43.8% who received the extension of 1000 mg mirikizumab achieved a clinical response; 15.0% and 9.4% achieved clinical remission, respectively. Endoscopic improvement was achieved by 20.0% of subjects in the 600 mg mirikizumab group and 15.6% subjects in the 1000 mg mirikizumab group. Among initial nonresponders to mirikizumab who had clinical response at study week 24 and continued into maintenance therapy, 65.8% maintained the clinical response, 26.3% achieved clinical remission, and 34.2% had endoscopic improvement at week 52. No new safety concerns were identified.
CONCLUSIONS


Extended doses of mirikizumab (600 mg and 1000 mg) for an additional 12 weeks produce a clinical response in up to 50% of patients who did not have a clinical response to 12 weeks of induction doses (50 mg, 200 mg, or 600 mg). Most of the responders to the extended doses maintained clinical response for up to 52 weeks. Clinicaltrials.gov no: NCT02589665.",2020,Endoscopic improvement was achieved by 20.0% of subjects in the 600 mg mirikizumab group and 15.6% subjects in the 1000 mg mirikizumab group.,"['Patients with Ulcerative Colitis', '75 sites in 14 countries, in which patients with moderate to severe ulcerative colitis', 'patients with moderate to severe ulcerative colitis', 'patients who did not initially respond to treatment with mirikizumab']","['mirikizumab or placebo', '200 mg subcutaneous mirikizumab', 'mirikizumab', 'I6T-MC-AMAC', 'Mirikizumab']","['Mayo subscore', 'clinical response', 'clinical remission', 'Efficacy and Safety', 'endoscopic improvement', 'Endoscopic improvement', 'rectal bleeding subscore of ≥1 or a rectal bleeding subscore', 'clinical remission (Mayo subscores of 0 for rectal bleeding, 0 or 1 with a 1-point decrease from baseline), clinical response, endoscopic remission (Mayo endoscopic subscore of 0), or endoscopic improvement (endoscopic subscore of 0 or 1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0993855,Endoscopic improvement was achieved by 20.0% of subjects in the 600 mg mirikizumab group and 15.6% subjects in the 1000 mg mirikizumab group.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'Universitair Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Bal R', 'Initials': 'BR', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, Bastrop, Louisiana.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Berliba', 'Affiliation': 'Arsenia EM, Chisinau, Moldova (the Republic of), Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Kitasato Institute Hospital Center for Advanced IBD Research and Treatment, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Tuttle', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Krueger', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Naegeli', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitz', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Western University, Robarts Clinical Trials Inc, London, ON, Canada.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.09.028']
3215,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
3216,32950829,Effects of perioperative magnesium sulfate with controlled hypotension on intraoperative bleeding and postoperative ecchymosis and edema in open rhinoplasty.,"PURPOSE


This randomized, double-blind study was planned to evaluate the effect of perioperative magnesium sulfate with controlled hypotension on intraoperative bleeding, postoperative ecchymosis and edema, and side-effects.
MATERIALS AND METHOD


Forty-nine patients undergoing open rhinoplasty were divided into two groups - magnesium sulfate and control. The magnesium sulfate group received 30-50 mg·kg -1  intravenously as a bolus before induction of anesthesia, followed by 10-20 mg·kg -1  h -1  by continuous intravenous infusion during surgery. Anesthesia was induced with propofol 3 mg·kg -1 , fentanyl 15 μg·kg -1  and cisatracurium 0.6 mg·kg -1 . Mean arterial pressure was maintained at 50 to 60 mmHg under controlled hypotensive anesthesia with magnesium sulfate titration. Hemodynamic variables, operational bleeding, early postoperative side-effects and postoperative first-, third- and seventh-day ecchymosis and edema were compared between the groups. Ecchymosis and edema were evaluated using a graded scale from 0 to 4.
RESULTS


In the magnesium sulfate group, mean arterial pressure decreased during most of the perioperative period. Intraoperative bleeding also decreased. A distinct reduction in ecchymosis and edema was observed in both the upper and lower eyelids on the first, third and seventh days. Patients in the magnesium sulfate group also had a more peaceful postoperative course with less postoperative nausea vomiting, and shivering.
CONCLUSION


Magnesium sulfate with controlled hypotension can lower ecchymosis and edema of the upper and lower eyelids in rhinoplasty surgery by reducing bleeding.",2020,"Patients in the magnesium sulfate group also had a more peaceful postoperative course with less postoperative nausea vomiting, and shivering.
",['Forty-nine patients undergoing open rhinoplasty'],"['propofol 3\xa0mg·kg -1 , fentanyl 15\xa0μg·kg -1  and cisatracurium 0.6\xa0mg·kg -1 ', 'magnesium sulfate titration', 'magnesium sulfate and control', 'perioperative magnesium sulfate with controlled hypotension', 'Magnesium sulfate with controlled hypotension', 'magnesium sulfate']","['Hemodynamic variables, operational bleeding, early postoperative side-effects and postoperative first-, third- and seventh-day ecchymosis and edema', 'intraoperative bleeding and postoperative ecchymosis and edema', 'postoperative nausea vomiting, and shivering', 'intraoperative bleeding, postoperative ecchymosis and edema, and side-effects', 'ecchymosis and edema', 'Ecchymosis and edema', 'Mean arterial pressure', 'Intraoperative bleeding', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396086', 'cui_str': 'Open rhinoplasty'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020650', 'cui_str': 'Induced hypotension'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",49.0,0.0351178,"Patients in the magnesium sulfate group also had a more peaceful postoperative course with less postoperative nausea vomiting, and shivering.
","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Omur', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Livaoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Plastic and Reconstructive Surgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102722']
3217,32966585,"Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest).","Nighttime agitation is a prevalent symptom in persons with Alzheimer's disease (AD). Effective treatments are absent due to our limited knowledge of its etiology. We hypothesized that restless legs syndrome (RLS), a common neurological sensorimotor disorder of uncomfortable leg sensations that appear at night and interfere with sleep, might be a cause for nighttime agitation in persons with AD. RLS is infrequently identified in persons with AD because traditional diagnosis is dependent on patients answering complex questions about their symptoms. With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects. We hypothesize that frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. This study is an 8-week, double-blind, placebo-controlled, randomized pilot clinical trial, followed by an 8-week open-label trial, that is being conducted in long-term care settings and private homes. The results of this study may shift, personalize, and improve standards of care for treatment of nighttime agitation; reduce aggression and other nighttime agitation behaviors; and improve sleep.
TARGETS


Persons with AD with nighttime agitation potentially caused by RLS.
INTERVENTION DESCRIPTION


Diagnose RLS and determine the effect of GEn.
MECHANISMS OF ACTION


The frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation.
OUTCOMES


Determine the effect of GEn on nighttime agitation, sleep, and antipsychotic medications.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03082755 (Date of registration March 6, 2017). [Research in Gerontological Nursing, 13(6), 280-288.].",2020,"With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects.","[""Persons With Alzheimer's Disease"", 'Persons with AD with nighttime agitation potentially caused by RLS', 'persons with AD', ""persons with Alzheimer's disease (AD""]","['placebo', 'GEn', 'Placebo', 'gabapentin enacarbil (GEn']","['Nighttime Agitation and Restless Legs Syndrome', 'nighttime agitation, sleep, and antipsychotic medications', 'Nighttime agitation', 'nighttime agitation, sleep, antipsychotic medications']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2700226', 'cui_str': 'Gabapentin enacarbil'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.449575,"With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects.","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Loera', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hanlon', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lozano', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kovach', 'Affiliation': ''}, {'ForeName': 'Nalaka', 'Initials': 'N', 'LastName': 'Gooneratne', 'Affiliation': ''}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Fry', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allen', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20200918-01']
3218,32967762,[Down-regulation of SIRT1 and PGC-1α expression caused by hyperoxia induces mitochondrial dysfunction in human alveolar epithelial cells].,"Objective To investigate SIRT1-PGC-1α signaling pathway-mediated effect of hyperoxia on mitochondrial function in A549 human alveolar epithelial cells and its possible mechanism. Methods Human alveolar epithelial cells in logarithmic growth phase were randomly divided into control group and hyperoxia group. The control group was cultured in a 37DegreesCelsius, 50 mL/L CO 2  saturated humidity incubator, and the hyperoxia group was treated with 950 mL/L O 2 . Following 24-hour culture, Mito SOX TM  staining was used to detect the level of mitochondrial reactive oxygen species (Mito-ROS) and JC-1 staining to detect the mitochondrial membrane potential. Real-time quantitative PCR was performed to detect the mitochondrial DNA content and the mRNA levels of SIRT1, PGC-1α, nuclear respiratory factor 1 (NRF1) and mitochondrial transcription factor A (TFAM), and Western blotting to detect the protein levels of SIRT1, PGC-1α, NRF1 and TFAM. Results Compared with the control group, the Mito-ROS of the hyperoxia group increased significantly, while the membrane potential decreased obviously; the mitochondrial DNA content of the hyperoxia group went down, and the mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped. Conclusion Hyperoxia induces mitochondrial dysfunction in human alveolar epithelial cells by inhibiting the expression of SIRT1 and PGC-1α.",2020,"Compared with the control group, the Mito-ROS of the hyperoxia group increased significantly, while the membrane potential decreased obviously; the mitochondrial DNA content of the hyperoxia group went down, and the mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped.","['A549 human alveolar epithelial cells', 'human alveolar epithelial cells', 'Methods Human alveolar epithelial cells in logarithmic growth phase']",['hyperoxia'],"['mitochondrial DNA content and the mRNA levels of SIRT1, PGC-1α, nuclear respiratory factor 1 (NRF1) and', 'mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped', 'Mito-ROS', 'mitochondrial DNA content']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0225698', 'cui_str': 'Pneumocyte'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}]","[{'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1565068', 'cui_str': 'NRF1 Transcription Factor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}]",,0.0199608,"Compared with the control group, the Mito-ROS of the hyperoxia group increased significantly, while the membrane potential decreased obviously; the mitochondrial DNA content of the hyperoxia group went down, and the mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China. *Corresponding author, E-mail: dongwenbin2000@163.com.'}]",Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology,[]
3219,32970784,A randomised trial of social support group intervention for people with aphasia: A Novel application of virtual reality.,"About a third of strokes cause aphasia, or language loss, with profound consequences for the person's social participation and quality of life. These problems may be mitigated by group social support. But this intervention is not available to all individuals. This study investigated whether it is feasible to deliver group social support to people with aphasia via a multi-user, virtual reality platform. It also explored the indicative effects of intervention and the costs. Intervention aimed to promote wellbeing and communicative success. It enabled participants to form new social connections and share experiences of living with aphasia. It comprised 14 sessions delivered over 6 months and was led by community based co-ordinators and volunteers. Feasibility measures comprised: recruitment and retention rates, compliance with intervention and assessment of treatment fidelity. Effects of intervention were explored using a waitlist randomised controlled design, with outcome measures of wellbeing, communication, social connectedness and quality of life. Two intervention groups were randomised to an immediate condition and two were randomised to a delayed condition. The main analysis explored scores on the measures between two time points, between which those in the immediate condition had received intervention, but those in the delayed group had not (yet). A comprehensive approach to economic data collection ensured that all costs of treatment delivery were recorded. Feasibility findings showed that the recruitment target was met (N = 34) and 85.3% (29/34) of participants completed intervention. All groups ran the 14 sessions as planned, and participants attended a mean of 11.4 sessions (s.d. 2.8), which was 81.6% of the intended dose. Fidelity checking showed minimal drift from the manualised intervention. No significant change was observed on any of the outcome measures, although the study was not powered to detect these. Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed. The results suggest that a larger trial of remote group support, using virtual reality, would be merited. However the treatment content and regime, and the selection of outcome measures should be reviewed before conducting the trial. Trail registration: Study registered with ClinicalTrials.gov; Identifier: https://www.ncbi.nlm.nih.gov/NCT03115268.",2020,"Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed.",['people with aphasia'],['social support group intervention'],"['recruitment and retention rates, compliance with intervention and assessment of treatment fidelity', 'wellbeing, communication, social connectedness and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0650251,"Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Devane', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Talbot', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Caute', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Cruice', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hilari', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'MacKenzie', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Maguire', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Anita Patel Health Economics Consulting Ltd, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Roper', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Centre for Human Computer Interaction Design, City, University of London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0239715']
3220,32971593,Blossom smart expander technology for tissue expander-based breast reconstruction facilitates shorter duration to full expansion: A pilot study.,"BACKGROUND


This study evaluated the Blossom system, an innovative self-filling, rate-controlled, pressure-responsive saline tissue expander (TE) system. We investigated the feasibility of utilizing this technology to facilitate implant-based and combined flap with implant-based breast reconstruction in comparison to conventional tissue expansion.
METHODS


In this prospective, single-center, single-surgeon pilot study, participants underwent either implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction. Outcome measures included time to full expansion, complications, total expansion volume, and pain scores.
RESULTS


Fourteen patients (TEs; n=22), were included in this study. The mean time to full expansion was 13.4 days (standard error of the mean [SEM], 1.3 days) in the combination group and 11.7 days (SEM, 1.4 days) in the implant group (P=0.78). The overall major complication rate was 4.5% (n=1). No statistically significant differences were found in the complication rate between the combination group and the implant group. The maximum patient-reported pain scores during the expansion process were low, but were significantly higher in the combination group (mean, 2.00±0.09) than in the implant group (mean, 0.29±0.25; P=0.005).
CONCLUSIONS


The reported average duration for conventional subcutaneous TE expansion is 79.4 days, but this pilot study using the Blossom system achieved an average expansion duration of less than 14 days in both groups. The Blossom system may accommodate single-stage breast reconstruction. The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs (20%-45%).",2020,No statistically significant differences were found in the complication rate between the combination group and the implant group.,['Fourteen patients (TEs; n=22'],"['combined flap with implant-based breast reconstruction', 'implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction']","['mean time to full expansion', 'overall complication rate', 'complication rate', 'time to full expansion, complications, total expansion volume, and pain scores', 'complication rates', 'overall major complication rate', 'pain scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0401048,No statistically significant differences were found in the complication rate between the combination group and the implant group.,"[{'ForeName': 'Youna K', 'Initials': 'YK', 'LastName': 'Choi', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}, {'ForeName': 'Danielle H', 'Initials': 'DH', 'LastName': 'Rochlin', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}, {'ForeName': 'Dung H', 'Initials': 'DH', 'LastName': 'Nguyen', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}]",Archives of plastic surgery,['10.5999/aps.2020.00535']
3221,32920065,DNA methylation of hypertension-related genes and effect of riboflavin supplementation in adults stratified by genotype for the MTHFR C677T polymorphism.,"BACKGROUND


The interaction between genetic, epigenetic and environmental factors plays an important role in the aetiology of hypertension. GWAS and observational studies link the C677T polymorphism in methylenetetrahydrofolate reductase (MTHFR) with hypertension, while riboflavin, the MTHFR cofactor, has been shown to reduce blood pressure and global DNA methylation in homozygous (TT genotype) individuals. It is currently unclear whether riboflavin modulates DNA methylation of other hypertension-related genes.
OBJECTIVES


To compare DNA methylation of hypertension-related genes in adults stratified by MTHFR genotype and effect of riboflavin intervention in adults with the variant MTHFR 677TT genotype.
METHOD


Pyrosequencing was carried out for hypertension-related genes (ACE, AGTR1, GCK, GNA12, IGF2, MMP9 and NOS3) in blood samples from participants in previous trials (CC, n = 40; TT, n = 40). The effect of intervention with riboflavin (1.6 mg/d for16 weeks) or placebo on DNA methylation was investigated in adults with the variant MTHFR 677TT genotype (n = 80).
RESULTS


Individuals with the MTHFR 677TT v CC genotype had significantly higher average DNA methylation at NOS3 (+1.66%, P = 0.044). In response to riboflavin supplementation in TT individuals, there was an increase in average DNA methylation at IGF2 (+1.09%, P = 0.019) and a decrease at ACE (-0.44%, P = 0.021) in females only. Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
CONCLUSION


This study provides the first RCT evidence that riboflavin alters DNA methylation of hypertension-related genes in adults with the MTHFR 677TT genotype, providing some insight into mechanisms linking hypertension with the genotype-specific response of BP to riboflavin.",2021,"Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
","['homozygous (TT genotype) individuals', 'adults with the variant MTHFR 677TT genotype', 'adults with the MTHFR 677TT genotype', 'adults with the variant MTHFR 677TT genotype (n\u202f=\u202f80']","['riboflavin', 'placebo', 'riboflavin intervention', 'riboflavin supplementation']","['blood pressure and global DNA methylation', 'DNA methylation', 'average DNA methylation at IGF2', 'average DNA methylation at NOS3']","[{'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4524020', 'cui_str': 'Riboflavin supplementation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C1569730', 'cui_str': 'insulin-like growth factor 2, human'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}]",,0.0498317,"Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
","[{'ForeName': 'Sophia D', 'Initials': 'SD', 'LastName': 'Amenyah', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK; Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Deane', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'McNulty', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Strain', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Horigan', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Purvis', 'Affiliation': 'Department of Cardiology, Altnagelvin Area Hospital, BT47 6SB, N. Ireland, UK.'}, {'ForeName': 'Colum P', 'Initials': 'CP', 'LastName': 'Walsh', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK.'}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Lees-Murdock', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine BT52 1SA, N. Ireland, UK. Electronic address: dj.lees@ulster.ac.uk.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.011']
3222,32922722,Cost-consequence analysis of self-administration of medication during hospitalization: a pragmatic randomized controlled trial in a Danish hospital setting.,"Objectives


The objective of this study was to evaluate the costs and consequences of introducing ""self-administration of medication"" (SAM) during hospitalization as compared with nurse-led dispensing and administration of medication.
Methods


This pragmatic randomized controlled trial was performed in a Danish Cardiology Unit. Patients ⩾18 years old capable of self-administering medication were eligible. In the intervention group, patients self-administered their medication. In the control group, medication was dispensed and administered by nurses. The implementation of SAM was used to evaluate the cost-consequences. The micro-costing analysis used the hospital perspective and a short-term incremental costing approach. The costs for medication, materials, and nursing time were included. Consequences included the dispensing error proportion, patients' perceptions regarding medication, satisfaction, and deviations in the medication list at follow-up. In addition, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge was included.
Results


The total cost (TC) per patient in the intervention group was 49.9€ (95% CI: 46.6-53.2) compared with 52.6€ (95% CI: 46.6-58.6) in the control group. The difference between the groups was not statistically significant ( p  = 0.09). Sensitivity analysis consistently showed TCs favoring the intervention. The dispensing error proportion was 9.7% (95% CI: 7.9-11.6) in the intervention group compared with 12.8% (95% CI: 10.9-15.6) in the control group. The difference was statistically significant ( p  = 0.02). The analysis also found changes in the perceptions regarding medication (indicating higher medication adherence), increased satisfaction, and fewer patients with deviations in the medication list at follow-up. No statistically significant differences between the groups in relation to readmissions and GP contacts within 30 days were observed.
Conclusions


SAM seems to cost less although the cost difference was small and not statistically significant. As SAM had positive effects on patient outcomes, the results indicate that SAM may be cost-effective.
Plain language summary


Self-administration of medication: a research study of the costs and consequences   Objectives  To evaluate the costs and consequences of introducing ""self-administration of medication"" (SAM) during hospitalization compared to medication dispensed by nurses.  Methods  This research study included patients ≥18 years capable of self-administering medication and was performed in a Danish cardiology unit. Patients self-administered their own medication during hospitalization in the intervention group, whereas nurses dispensed and administered the medication in the control group. Patients were allocated between groups by randomization. The costs of SAM were analyzed from a hospital perspective and included costs for medication, materials, and nursing time. The consequences included the proportion of dispensing errors, patients' perceptions regarding medication, patient satisfaction, deviations in the medication list at follow-up, the number of readmissions and general practitioner (GP) contacts within 30 days after discharge.  Results  The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p  = 0.09). The cost difference between groups was not significant. The proportion of dispensing errors was significantly lower in the intervention group compared to the control group. In addition the research study found changes in the perceptions regarding medication, increased satisfaction, and fewer patients with deviations in the medication list at follow-up. For readmissions and GP contacts within 30 days no significant differences between groups were found.  Conclusion  SAM cost less or equal to medication dispensing and administration by nurse. SAM had positive impacts on patient outcomes. Therefore, SAM may be cost-effective.",2020,The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p  = 0.09).,"['patients\u2009≥18 years capable of self-administering medication and was performed in a Danish cardiology unit', 'Patients ⩾18\u2009years old capable of self-administering medication were eligible', 'Danish Cardiology Unit']","['self-administration of medication"" (SAM', 'Plain language summary\n\n\nSelf-administration of medication']","['relation to readmissions and GP contacts', 'total cost per patient', 'costs for medication, materials, and nursing time', 'total cost (TC', 'costs of SAM', ""dispensing error proportion, patients' perceptions regarding medication, satisfaction, and deviations in the medication list"", 'number of readmissions and general practitioner (GP) contacts', 'dispensing error proportion', ""proportion of dispensing errors, patients' perceptions regarding medication, patient satisfaction, deviations in the medication list at follow-up, the number of readmissions and general practitioner (GP) contacts"", 'proportion of dispensing errors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0389782,The total cost per patient was 49.9€ in the intervention group compared to 52.6€ in the control group ( p  = 0.09).,"[{'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Randers Regional Hospital, Dronningborg Boulevard 16D, Randers NØ, 8930, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'de Thurah', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Health, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Health, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Olesen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Clinical Pharmacy, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Signe Bredsgaard', 'Initials': 'SB', 'LastName': 'Sørensen', 'Affiliation': 'Medical Department, Cardiology unit, Randers Regional Hospital, Denmark.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Enemark', 'Affiliation': 'Department of Public Health, Aarhus University, Denmark.'}]",Therapeutic advances in drug safety,['10.1177/2042098620929921']
3223,32930649,Comparing Screening Outcomes for Digital Breast Tomosynthesis and Digital Mammography by Automated Breast Density in a Randomized Controlled Trial: Results from the To-Be Trial.,"Background Digital breast tomosynthesis (DBT) is considered superior to digital mammography (DM) for women with dense breasts. Purpose To identify differences in screening outcomes, including rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM. Materials and Methods This randomized controlled trial comparing DBT+SM and DM was performed in Bergen as part of BreastScreen Norway, 2016-2017. Automated software measured density (Volpara Density Grade [VDG], 1-4). The outcomes were compared for DBT+SM versus DM by VDG in descriptive analyses. A stratified log-binomial regression model was used to estimate relative risk of outcomes in subgroups by screening technique. Results Data included 28 749 women, 14 380 of whom were screened with DBT+SM and 14 369 of whom were screened with DM (both groups: median age, 59 years; interquartile range [IQR], 54-64 years). The recall rate was lower for women screened with DBT+SM versus those screened with DM for VDG 1 (2.1% [81 of 3929] vs 3.3% [106 of 3212];  P  = .001) and VDG 2 (3.2% [200 of 6216] vs 4.3% [267 of 6280];  P  = .002). For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8;  P  < .001; VDG 3: 2.4;  P  < .001; VDG 4: 1.8;  P  = .02) and screen-detected breast cancer (VDG 2: 2.4;  P  = .004; VDG 3: 2.8;  P  = .01; VDG 4: 2.8;  P  = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3;  P  = .06; VDG 3: 1.1;  P  = .41; VDG 4: 1.1;  P  = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7;  P  = .13; VDG 3: 2.1;  P  = .06; VDG 4: 2.2;  P  = .15). Conclusion Screening with digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM) yielded lower recall rates for women with Volpara Density Grade (VDG) 1 and VDG 2. Adjusted relative risk of recall and screen-detected breast cancer increased with denser breasts for DBT+SM but not for DM. © RSNA, 2020  Online supplemental material is available for this article.  See also the editorial by Sechopoulos and Athanasiou in this issue.",2020,"For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8;  P  < .001; VDG 3: 2.4;  P  < .001; VDG 4: 1.8;  P  = .02) and screen-detected breast cancer (VDG 2: 2.4;  P  = .004; VDG 3: 2.8;  P  = .01; VDG 4: 2.8;  P  = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3;  P  = .06; VDG 3: 1.1;  P  = .41; VDG 4: 1.1;  P  = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7;  P  = .13; VDG 3: 2.1;  P  = .06; VDG 4: 2.2;  P  = .15).","['Bergen as part of BreastScreen Norway, 2016-2017', 'women with dense breasts', 'women with Volpara Density Grade (VDG) 1 and VDG 2', '28\u2009749 women, 14\u2009380 of whom were screened with DBT+SM and 14\u2009369 of whom were screened with DM (both groups: median age, 59 years; interquartile range [IQR], 54-64 years']","['DBT+SM and DM', 'Digital Breast Tomosynthesis and Digital Mammography', 'DBT+SM', 'digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM', ' Digital breast tomosynthesis (DBT', 'digital mammography (DM']","['Adjusted relative risk of recall and screen-detected breast cancer', 'recall rates', 'relative risk of screen-detected breast cancer', 'rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM', 'recall rate']","[{'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}]",28749.0,0.19577,"For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8;  P  < .001; VDG 3: 2.4;  P  < .001; VDG 4: 1.8;  P  = .02) and screen-detected breast cancer (VDG 2: 2.4;  P  = .004; VDG 3: 2.8;  P  = .01; VDG 4: 2.8;  P  = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3;  P  = .06; VDG 3: 1.1;  P  = .41; VDG 4: 1.1;  P  = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7;  P  = .13; VDG 3: 2.1;  P  = .06; VDG 4: 2.2;  P  = .15).","[{'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Moshina', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Hildegunn S', 'Initials': 'HS', 'LastName': 'Aase', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Anders S', 'Initials': 'AS', 'LastName': 'Danielsen', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Ingfrid S', 'Initials': 'IS', 'LastName': 'Haldorsen', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Christoph I', 'Initials': 'CI', 'LastName': 'Lee', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zackrisson', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Hofvind', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}]",Radiology,['10.1148/radiol.2020201150']
3224,32927269,The effect of remote patient monitoring on the primary care clinic visit frequency among adults with type 2 diabetes.,"AIMS


Healthcare organizations are increasingly using technology to assist in diabetes management based on telemedicine's proven ability to improve glycemic regulation, decrease cost, and overcome barriers to effective healthcare. Nevertheless, it remains unclear how telemedicine intersects with primary care. We aim to measure the impact of a remote monitoring program for diabetes on primary care delivery through analysis of primary care office visit frequency.
METHODS


Patients eligible to participate in our institution's remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care""). The number of scheduled and completed primary care office visits in the 12 months prior to and after the index date were measured for both groups. The index date was the enrollment date or, for the patients who received usual care, the next available enrollment session after eligibility screen. Two-sample t-tests were used to examine the change in frequency of office visits prior to and after enrollment for participants, as well as the difference in visit frequency between enrolled patients versus patients receiving usual care.
RESULTS


There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth. Furthermore, there was no difference in the number of scheduled or completed primary care visits between patients enrolled in telehealth versus those receiving usual care.
CONCLUSION


Participation in telehealth has been shown to be associated with significant HbA1c reductions in prior work, yet our data suggest that remote monitoring is not associated with a change in primary care office visit frequency. This suggests that telehealth may improve diabetes management independently of primary care visits.",2020,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"['adults with type 2 diabetes', 'Patients eligible to participate in our institution\'s remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care']","['remote monitoring program', 'remote patient monitoring']",['number of scheduled or completed primary care clinic visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0422587', 'cui_str': 'Diabetes monitoring check done'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]",,0.0160126,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"[{'ForeName': 'Morgan Hampton', 'Initials': 'MH', 'LastName': 'Randall', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary Merle', 'Initials': 'ZM', 'LastName': 'Haulsee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William Patrick', 'Initials': 'WP', 'LastName': 'Moran', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth Barnhardt', 'Initials': 'EB', 'LastName': 'Kirkland', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kirklane@musc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104267']
3225,32938620,Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial.,"PURPOSE


To assess palbociclib in combination with trastuzumab with or without endocrine therapy in patients with HER2-positive advanced breast cancer.
PATIENTS AND METHODS


PATRICIA is a prospective, open-label, multicenter phase II trial. Patients had received 2-4 prior lines of anti-HER2-based regimens. Treatment consisted of palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab. The study was based on a Simon two-stage design comprising three cohorts: estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1), and ER-positive with letrozole (cohort B2). ER-positive patients were randomized to cohorts B1 or B2. Primary endpoint was progression-free survival rate at 6 months (PFS6). Secondary objectives included safety and evaluation of the PAM50 intrinsic subtypes.
RESULTS


Seventy-one patients were recruited ( n  = 15 in cohort A and 28 in each cohort B). The PFS6 rate in cohorts A, B1, and B2 was 33.3% (5/15), 42.8% (12/28), and 46.4% (13/28), respectively. Regarding safety, grade 1-2 and 3-4 toxicities occurred in 97.7% and 84.4% of patients, respectively. The most common grade 3-4 toxicities were neutropenia (66.4%) and thrombocytopenia (11.3%). Regarding PAM50, 59 (83.1%) tumors were profiled. Luminal disease defined by PAM50 was found independently associated with longer PFS compared with non-luminal disease (10.6 vs. 4.2 months median PFS; adjusted hazard ratio = 0.40;  P  = 0.003).
CONCLUSIONS


Palbociclib in combination with trastuzumab is safe and exhibits promising survival outcomes in trastuzumab pretreated ER-positive/HER2-positive advanced breast cancer with a PAM50 Luminal A or B subtype. The enrollment was stopped prematurely, and a new randomized cohort was opened in this population.",2020,"The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively.","['HER2-positive advanced breast cancer', '71 patients were recruited (n=15 in cohort A and 28 in each cohort B', 'patients with HER2-positive advanced breast cancer', 'ER-positive patients']","['trastuzumab with or without endocrine therapy', 'trastuzumab', 'Palbociclib and trastuzumab', 'palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab', 'estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1) and ER-positive with letrozole']","['safety and evaluation of the PAM50 intrinsic subtypes', 'progression-free survival rate', 'thrombocytopenia', 'PFS6 rate', 'neutropenia', 'toxicities']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",71.0,0.127422,"The PFS6 rate in cohorts A, B1 and B2 was 33.3% (5/15), 42.8% (12/28) and 46.4% (13/28), respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain. eva.ciruelos@gmail.com alprat@clinic.cat.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Villagrasa', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Escrivá-de-Romaní', 'Affiliation': ""Vall d' Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez', 'Affiliation': 'Consorcio Hospitalario Provincial de Castellón, Castellón de la Plana, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'IOB Institute of Oncology, Quiron Group, Madrid & Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Vazquez', 'Affiliation': ""Institut Català d'Oncologia, Hospitalet del Llobregat, Spain.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Perelló', 'Affiliation': 'Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Garau', 'Affiliation': 'Hospital Son Llàtzer, Palma de Mallorca, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Melé', 'Affiliation': 'Hospital Universitari Sant Joan de Reus, Reus, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Martínez', 'Affiliation': 'Hospital Universitario Ramon y Cajal, Madrid, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Montaño', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Bermejo', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Serafin', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Echarri', 'Affiliation': 'Hospital Universitario Severo Ochoa, Madrid, Spain.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Centro Integral Oncológico Clara Campal HM (CIOCC), Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'González-Farré', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': ""Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Canes', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall d' Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gonzalez', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain. eva.ciruelos@gmail.com alprat@clinic.cat.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0844']
3226,32939553,"High-Dose Neonatal Vitamin A Supplementation to Bangladeshi Infants Increases the Percentage of CCR9-Positive Treg Cells in Infants with Lower Birthweight in Early Infancy, and Decreases Plasma sCD14 Concentration and the Prevalence of Vitamin A Deficiency at Two Years of Age.","BACKGROUND


Vitamin A (VA) stores are low in early infancy and may impair development of the immune system.
OBJECTIVE


This study determined if neonatal VA supplementation (VAS) affects the following: 1) development of regulatory T (Treg) cells; 2) chemokine receptor 9 (CCR9) expression, which directs mucosal targeting of immune cells; and 3) systemic endotoxin exposure as indicated by changed plasma concentrations of soluble CD14 (sCD14). Secondarily, VA status, growth, and systemic inflammation were investigated.
METHODS


In total, 306 Bangladeshi infants were randomly assigned to receive 50,000 IU VA or placebo (PL) within 48 h of birth, and immune function was assessed at 6 wk, 15 wk, and 2 y. Primary outcomes included the following: 1) peripheral blood Treg cells; 2) percentage of Treg, T, and B cells expressing CCR9; and 3) plasma sCD14. Secondary outcomes included the following: 4) VA status measured using the modified relative dose-response (MRDR) test and plasma retinol; 5) infant growth; and 6) plasma C-reactive protein (CRP). Statistical analysis identified group differences and interactions with sex and birthweight.
RESULTS


VAS increased (P = 0.004) the percentage of CCR9+ Treg cells (13.2 ± 1.37%) relative to PL (9.17 ± 1.15%) in children below the median birthweight but had the opposite effect (P = 0.04) in those with higher birthweight (VA, 9.13 ± 0.89; PL, 12.1 ± 1.31%) at 6 and 15 wk (values are combined mean ± SE). VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y.
CONCLUSIONS


Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants. The decreased systemic exposure to endotoxin and improved VA status at 2 y may have been due to VA-mediated improvements in gut development resulting in improved barrier function and nutrient absorption. This trial was registered at clinicaltrials.gov as NCT01583972 and NCT02027610.",2020,"VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y.
CONCLUSIONS


Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants.",['306 Bangladeshi infants'],"['neonatal VA supplementation (VAS', 'placebo (PL']","['1) peripheral blood Treg cells; 2) percentage of Treg, T, and B cells expressing CCR9; and 3) plasma sCD14', 'Plasma sCD14 Concentration', 'plasma sCD14', 'Secondarily, VA status, growth, and systemic inflammation', 'VAS', 'plasma concentrations of soluble CD14 (sCD14', 'percentage of CCR9+ Treg cells', '4) VA status measured using the modified relative dose-response (MRDR) test and plasma retinol; 5) infant growth; and 6) plasma C-reactive protein (CRP']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1872956', 'cui_str': 'CCR9 protein, human'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",306.0,0.392912,"VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y.
CONCLUSIONS


Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants.","[{'ForeName': 'Shaikh M', 'Initials': 'SM', 'LastName': 'Ahmad', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'M Nazmul', 'Initials': 'MN', 'LastName': 'Huda', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Rubhana', 'Initials': 'R', 'LastName': 'Raqib', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md Jahangir', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Md Nure Alam', 'Initials': 'MNA', 'LastName': 'Afsar', 'Affiliation': 'Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Peerson', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Stephensen', 'Affiliation': 'USDA Western Human Nutrition Research Center at University of California, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa260']
3227,32942663,Assessment of Active Video Games' Energy Expenditure in Children with Overweight and Obesity and Differences by Gender.,"(1) Background: Childhood obesity has become a main global health problem and active video games (AVG) could be used to increase energy expenditure. The aim of this study was to investigate the energy expenditure during an AVG intervention combined with exercise, differentiating by gender. (2) Methods: A total of 45 children with overweight or obesity (19 girls) performed an AVG intervention combined with exercise. The AVG used were the Xbox Kinect, Nintendo Wii, dance mats, BKOOL cycling simulator, and Nintendo Switch. The energy expenditure was estimated from the heart rate recorded during the sessions and the data from the individual maximal tests. (3) Results: The mean energy expenditure was 315.1 kilocalories in a one-hour session. Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii. Significant differences between boys and girls were found, but were partially due to the difference in weight, VO 2max , and fat-free mass. (4) Conclusions: The energy expenditure with AVG combined with multi-component exercise was 5.68 kcal/min in boys and 4.66 kcal/min in girls with overweight and obesity. AVG could be an effective strategy to increase energy expenditure in children and adolescents with overweight and obesity.",2020,"Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii.","['Children with Overweight and Obesity and Differences by Gender', 'girls with overweight and obesity', 'children and adolescents with overweight and obesity', '45 children with overweight or obesity (19 girls']","['AVG combined with multi-component exercise', 'AVG intervention combined with exercise', 'AVG']","['mean energy expenditure', 'weight, VO 2max , and fat-free mass', 'energy expenditure', 'heart rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",45.0,0.0423385,"Participants spent the most energy on BKOOL, followed by Ring Fit Adventures, Dance Mats, Xbox Kinect, and the Nintendo Wii, with significant differences between BKOOL and the Nintendo Wii.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Comeras-Chueca', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Villalba-Heredia', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Pérez-Llera', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lozano-Berges', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Marín-Puyalto', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Vicente-Rodríguez', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Matute-Llorente', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Casajús', 'Affiliation': 'GENUD (Growth, Exercise, Nutrition and Development) Research Group, Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-Agüero', 'Affiliation': 'Faculty of Health and Sport Science (FCSD), Department of Physiatry and Nursing, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186714']
3228,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
3229,32950246,Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.,"BACKGROUND


The majority of postoperative patients report moderate to severe pain, possibly related to opioid underdosing or overdosing during surgery. Objective guidance of opioid dosing using the Nociception Level (NOL) index, a multiparameter artificial intelligence-driven index designed to monitor nociception during surgery, may lead to a more appropriate analgesic regimen, with effects beyond surgery. We tested whether NOL-guided opioid dosing during general anaesthesia results in less postoperative pain.
METHODS


In this two-centre RCT, 50 patients undergoing abdominal surgery under fentanyl/sevoflurane anaesthesia were randomised to NOL-guided fentanyl dosing or standard care in which fentanyl dosing was based on haemodynamics. The primary endpoint of the study was postoperative pain assessed in the PACU.
RESULTS


Median postoperative pain scores were 3.2 (inter-quartile range 1.3-4.3) and 4.8 (3.0-5.3) in NOL-guided and standard care groups, respectively (P=0.006). Postoperative morphine consumption (standard deviation) was 0.06 (0.07) mg kg -1  (NOL-guided group) and 0.09 (0.09) mg kg -1  (control group; P=0.204). During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] μg kg -1 vs standard care: 6.0 [2.2] μg kg -1 , P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).
CONCLUSIONS


Despite absence of differences in fentanyl and morphine consumption during and after surgery, a 1.6-point improvement in postoperative pain scores was observed in the NOL-guided group. We attribute this to NOL-driven rather than BP- and HR-driven fentanyl dosing during anaesthesia.
CLINICAL TRIAL REGISTRATION


www.trialregister.nl under identifier NL7845.",2020,"During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] μg kg -1 vs standard care: 6.0 [2.2] μg kg -1 , P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).
",['50 patients undergoing abdominal surgery under fentanyl/sevoflurane anaesthesia'],"['sevoflurane anaesthesia', 'NOL-guided fentanyl dosing or standard care in which fentanyl', 'NOL-guided opioid']","['Postoperative morphine consumption (standard deviation', 'Nociception Level (NOL) index', 'postoperative pain assessed in the PACU', 'Median postoperative pain scores', 'postoperative pain scores', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.125131,"During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] μg kg -1 vs standard care: 6.0 [2.2] μg kg -1 , P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).
","[{'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Meijer', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Honing', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Roor', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands; Department of Anesthesiology, Alrijne Hospital, Leiderdorp, Netherlands.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Toet', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands; Department of Anesthesiology, Alrijne Hospital, Leiderdorp, Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calis', 'Affiliation': 'Department of Anesthesiology, Alrijne Hospital, Leiderdorp, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Olofsen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Martini', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Aarts', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Boon', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: a.dahan@lumc.nl.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.057']
3230,32950330,The effect of a shelf placement intervention on sales of healthier and less healthy breakfast cereals in supermarkets: A co-designed pilot study.,"Supermarkets are the principal source of grocery food in many high-income countries. Choice architecture strategies show promise to improve the healthiness of food choices. A retailer-academic collaboration was formed to co-design and pilot selected commercially sustainable strategies to increase sales of healthier foods relative to less healthy foods in supermarkets. Two co-design workshops, involving supermarket corporate staff and public health nutrition academics, identified potential interventions. One intervention, more prominent shelf placement of healthier products within one category (breakfast cereals), was selected for testing. A pilot study (baseline, intervention and follow-up, 12-weeks each) was undertaken in six supermarkets (three intervention and three control) in Auckland, New Zealand. Products were ranked by nutrient levels and profile, and after accounting for the supermarkets' space management principles, healthier products were placed at adult eye level. The primary outcome was change in sales of healthier products relative to total category sales. Secondary outcomes were nutrient profile of category sales, in-store product promotions, customer perceptions, and retailer feedback. There was no difference in proportional sales of more prominently positioned healthier products between intervention (56%) and control (56%) stores during the intervention. There were no differences in the nutrient profile of category sales. A higher proportion of less healthy breakfast cereals were displayed in intervention versus control stores (57% vs 43%). Most customers surveyed supported shelf placement as a strategy (265, 88%) but noted brand preferences and price were more salient determinants of purchases. Retailers were similarly supportive but balancing profit, health/nutrition and customer satisfaction was challenging. Shelf placement alone was not an effective strategy to increase purchases of healthier breakfast cereals. This study showed co-design of a healthy eating intervention with a commercial retailer is feasible, but concurrent retail environment factors likely limited the public health impact of the intervention.",2020,There was no difference in proportional sales of more prominently positioned healthier products between intervention (56%) and control (56%) stores during the intervention.,['sales of healthier and less healthy breakfast cereals in supermarkets'],"['healthy eating intervention', 'shelf placement intervention']","['nutrient profile of category sales', 'change in sales of healthier products relative to total category sales', 'nutrient profile of category sales, in-store product promotions, customer perceptions, and retailer feedback', 'healthy breakfast cereals', 'proportional sales']","[{'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}]",,0.0487893,There was no difference in proportional sales of more prominently positioned healthier products between intervention (56%) and control (56%) stores during the intervention.,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. Electronic address: leanne.young@auckland.ac.nz.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Rosin', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Grey', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Vandevijvere', 'Affiliation': 'Scientific Institute of Public Health (Sciensano), Rue Juliette Wytsmanstraat 14, 1050, Brussels, Belgium.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Waterlander', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Public Health, P.O. Box 19268, 1000, GG Amsterdam, the Netherlands.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'Ni Mhurchu', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113337']
3231,32951151,Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial.,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) is a viral respiratory syndrome caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This novel virus was discovered in Wuhan City, Hubei Province, China, in December 2019. As of September 6, 2020, confirmed cases have risen to more than 27,000,000 worldwide and more than 885,000 people have died. Currently, no cure or standard treatment for COVID-19 exists. We conducted a prospective single-arm open-label phase II clinical trial assessing the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19.
METHODS


Convalescent plasma with sufficient total anti-SARS-CoV-2 IgG titer (1:320) obtained from recovered donors was administered to adult patients with either severe or critical COVID-19 illness. Primary outcomes were adverse events in association with plasma administration, and hospital mortality. Secondary outcomes included disease progression, recovery, length of stay, and hospital discharge.
RESULTS


Of the 38 patients included in the analysis, 24 (63%) recovered and were discharged, and 14 (37%) died. Patients who received convalescent plasma early in the disease course (severe illness group) as compared to the patients that received convalescent plasma later in the disease progression (critical illness group) had significantly lower hospital mortality 13% vs 55% (p < 0.02) and shorter mean hospital length of stay 15.4 vs 33 days (p < 0.01). One patient experienced a transient transfusion reaction. No other adverse effects of convalescent plasma infusion were observed.
CONCLUSIONS


Our results suggest that convalescent plasma with adequate anti-SARS-CoV-2 antibody titer is safe and has the potential for positive impact on clinical outcomes including recovery and survival if given to patients early in the course of COVID-19 disease.
TRIAL REGISTRATION


ClinicalTrials.gov. Identifier, NCT04343261, IND #19805.",2020,"No other adverse effects of convalescent plasma infusion were observed.
","['Convalescent plasma with sufficient total anti-SARS-CoV-2 IgG titer (1:320) obtained from recovered donors was administered to adult patients with either severe or critical COVID-19 illness', 'Wuhan City, Hubei Province, China, in December 2019', 'COVID-19', 'hospitalized patients with COVID-19']",[],"['adverse events in association with plasma administration, and hospital mortality', 'transient transfusion reaction', 'hospital mortality', 'safety and efficacy', 'disease progression, recovery, length of stay, and hospital discharge', 'mean hospital length of stay']","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0841188,"No other adverse effects of convalescent plasma infusion were observed.
","[{'ForeName': 'Danyal', 'Initials': 'D', 'LastName': 'Ibrahim', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA. dibrahim@trinityhealthofne.org.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Dulipsingh', 'Affiliation': 'Diabetes Center, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zapatka', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Eadie', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Crowell', 'Affiliation': 'Research Department, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Research Department, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Dorothy B', 'Initials': 'DB', 'LastName': 'Wakefield', 'Affiliation': 'Research Department, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'Diabetes Center, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Puff', 'Affiliation': 'Diabetes Center, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00341-2']
3232,32956698,"Growth from Birth Through Six Months for Infants of Mothers in the ""Women First"" Preconception Maternal Nutrition Trial.","OBJECTIVE


To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age.
STUDY DESIGN


The Women First trial was a multicountry, individually randomized clinical trial that compared the impact of maternal nutrition supplementation initiated preconception (Arm 1) vs at ∼11 weeks of gestation (Arm 2), vs no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were in Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age z scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates.
RESULTS


Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI 0.15-0.35; P < .001) and 0.19 (95% CI 0.09-0.28; P < .001), respectively. Compared with Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <-2) were lower for Arms 1 and 2: 0.76 (0.66-0.87; P < .001) and 0.77 (0.67-0.88; P < .001), respectively.
CONCLUSIONS


Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition before conception and in the early phase of gestation.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01883193.",2020,"RESULTS


Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively.",['2421 infants born to 2408 randomized women'],"['maternal nutrition supplementation initiated preconception', 'maternal nutrition supplementation']",['trajectory of length-for-age Z-scores (LAZ'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",2408.0,0.359219,"RESULTS


Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively.","[{'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Westcott', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Garcés', 'Affiliation': 'Institute of Nutrition in Central America and Panama (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Institute of Nutrition in Central America and Panama (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Antoinette K', 'Initials': 'AK', 'LastName': 'Tsefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Adrien L', 'Initials': 'AL', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumera Aziz', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina, Raleigh, NC.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Thorsten', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Dhuly', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.032']
3233,32957009,Meal skipping and cognition along a spectrum of restrictive eating.,"OBJECTIVE


Inadequate nutrition adversely impacts brain development and cognitive functioning (Pollitt et al., 1983). Studies examining the acute impact of eating regular meals on cognition have reported inconsistent findings, necessitating the exploration of individual differences in samples contributing to equivocal results. The present study examines the impact of skipping lunch on cognitive ability in college-aged students by including eating restraint as a moderator.
METHODS


Participants were 99 college-aged students (M = 19.7 years, SD = 1.5) randomized to a blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting, and eating disorder symptomology.
RESULTS


Regressing long and short-term memory on the lunch manipulation, eating restraint scores, and their interaction revealed significant interactions: those who had lunch had superior memory performance, but only for those reporting lower levels of eating restraint. Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
CONCLUSIONS


Results suggest that skipping lunch may have immediate consequences on cognition, however, cognitive enhancing effects may be diminished in the presence of even low levels of eating restraint. Findings highlight the significance of purported subclinical levels of eating restraint and may inform health education strategies.",2020,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","['college-aged students by including eating restraint as a moderator', 'Participants were 99 college-aged students (M\xa0=\xa019.7\xa0years, SD\xa0=\xa01.5) randomized to a']","['skipping lunch', ""blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting""]","['cognitive ability', 'superior memory performance', 'lunch manipulation, eating restraint scores']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0492838,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address: nandinid@stanford.edu.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Bidopia', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gaurie', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Alphin', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Marsh', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gavan J', 'Initials': 'GJ', 'LastName': 'Fitzsimons', 'Affiliation': 'Duke University Fuqua School of Business, Durham, NC, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Strauman', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Zucker', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA; Duke University School of Medicine Department of Psychiatry & Behavioral Sciences, Durham, NC, USA.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101431']
3234,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES


To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN


Single-blinded randomized cross-over trial.
SETTING


Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES


Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS


There were no group × intervention interactions for change in pain (F (1, 26)  = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26)  = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS


A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
3235,32935747,DIAGNOSTIC ACCURACY OF ONE SAMPLE OR TWO SAMPLES QUANTITATIVE FECAL IMMUNOCHEMICAL TESTS FOR INTESTINAL NEOPLASIA DETECTION.,"BACKGROUND


Rectal bleeding is the most important symptom of intestinal neoplasia; thus, tests of occult blood detection in stools are widely used for pre neoplastic lesions and colorectal cancer (CRC) screening.
OBJECTIVE


Evaluate the accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan) at cut-off 10 µg Hb/g feces (50 ng/mL) in a cohort of subjects that had to undergo diagnostic colonoscopy, and if more than one sample collected in consecutive days would improve the diagnostic accuracy of the test.
METHODS


Patients (mean age 56.3±9.7 years) that underwent colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes. They collected the stool sample before starting colonoscopy preparation. Samples were analyzed by the OC-Auto Micro 80 (Eiken Chemical, Tokyo, Japan). The performance of FIT 1 and FIT 2 were compared to the colonoscopy findings.
RESULTS


Among 289 patients, CRC was diagnosed in 14 (4.8%), advanced adenoma in 37 (12.8%), early adenoma in 71 (24.6%) and no abnormalities in 141 (48.8%). For FIT 1, the sensitivity for CRC was 83.3% (95%CI 36.5-99.1%), for advanced adenoma was 24% (95%CI 10.1-45.5%), with specificity of 86.9% (95%CI 77.3-92.9%). For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%). The positive likelihood ratios were 1.8 (95%CI 0.7-4.4 for FIT 1) and 7.1 (95%CI 2.4-21.4 for FIT 2) for advanced adenoma, and 6.4 (95%CI 3.3-12.3, for FIT 1) and 10.7 (95%CI 3.8-29.8, for FIT 2) for CRC. The negative likelihood ratio were 0.9 (95%CI 0.7-1, for FIT 1) and 0.5 (95%CI 0.3-0.9, for FIT 2) for advanced adenoma, and 0.2 (0.03-1.1, for FIT 1) and 0.3 (0.08-0.9, for FIT 2) for CRC. The differences between FIT 1 and FIT 2 performances were not significant. However, the comparison of the levels of hemoglobin in feces of patients of FIT 1 and FIT 2 showed that the differences between no polyp group and advanced adenoma and CRC were significant.
CONCLUSION


The accuracy of OCR Sensor with 10 µg Hb/g feces cut-off was comparable to other reports and two-sample collection improved the detection rate of advanced adenoma, a pre neoplastic condition to prevent CRC incidence.",2020,"For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%).",['Patients (mean age 56.3±9.7 years) that underwent'],"['colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes']","['accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan', 'positive likelihood ratios', 'advanced adenoma', 'early adenoma', 'sensitivity for CRC', 'negative likelihood ratio', 'detection rate of advanced adenoma', 'diagnostic accuracy', 'advanced adenoma and CRC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",289.0,0.103434,"For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%).","[{'ForeName': 'Rejane', 'Initials': 'R', 'LastName': 'Mattar', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Gastroenterologia e Hepatologia Clínica, São Paulo, SP, Brasil.'}, {'ForeName': 'Sergio Barbosa', 'Initials': 'SB', 'LastName': 'Marques', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}, {'ForeName': 'Maurício Kazuyoshi', 'Initials': 'MK', 'LastName': 'Minata', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}, {'ForeName': 'Joyce Matie Kinoshita da', 'Initials': 'JMKD', 'LastName': 'Silva-Etto', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Gastroenterologia e Hepatologia Clínica, São Paulo, SP, Brasil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sakai', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}, {'ForeName': 'Eduardo Guimarães Hourneaux', 'Initials': 'EGH', 'LastName': 'DE Moura', 'Affiliation': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), Divisão de Endoscopia, São Paulo, SP, Brasil.'}]",Arquivos de gastroenterologia,['10.1590/S0004-2803.202000000-58']
3236,32936981,A pilot randomized trial of an educational intervention to increase genetic counseling and genetic testing among Latina breast cancer survivors.,"Latinas are less likely to participate in genetic counseling (GC) and genetic testing (GT) than non-Hispanic Whites. A multisite, randomized pilot study tested a culturally targeted educational intervention to increase uptake of GC/GT among Latina breast cancer (BC) survivors (N = 52). Participants were recruited in Tampa, FL and Ponce, PR and randomized to: (a) fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention). Participants in the intervention condition were also offered no-cost telephone GC followed by free GT with mail-based saliva sample collection. Participants self-reported hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress at baseline and 1- and 3-month follow-ups. We used logistic regression to examine differences in GC/GT uptake by study arm (primary outcome) and repeated measures ANOVA to examine the effects of study arm and time on HBOC knowledge and emotional distress (secondary outcomes). Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01). Study site did not predict uptake of GC (p = .08) but Ponce participants were more likely to complete GT (OR Ponce   = 4.53, 95% CI = 1.04-19.72, p = .04). ANOVAs demonstrated an increase in HBOC knowledge over time across both groups (F(2,88) = 12.24, p < .01, η p   2   = 0.22). We also found a significant interaction of study arm and time, such that intervention participants demonstrated a greater and sustained (to the 3-month follow-up) increase in knowledge than control participants (F(2,88) = 3.66, p = .03, η p   2   = 0.08). No other main or interaction effects were significant (all p's> .15). Study findings demonstrate the potential of our culturally targeted print intervention. Lessons learned from this multisite pilot study for enhancing GC/GT in Latinas include the need to attend to both access to GC/GT and individual factors such as attitudes and knowledge.",2020,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01).","['Latina breast cancer (BC) survivors (N\xa0=\xa052', 'Latina breast cancer survivors']","['culturally targeted educational intervention', 'fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention', 'educational intervention']","['hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress', 'HBOC knowledge', 'HBOC knowledge and emotional distress']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0677776', 'cui_str': 'Hereditary breast and ovarian cancer syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.0506475,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01).","[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Conley', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eida M', 'Initials': 'EM', 'LastName': 'Castro-Figueroa', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dutil', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'García', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Burgos', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Charité', 'Initials': 'C', 'LastName': 'Ricker', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Jongphil', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Georgetown Lombardi Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Kimlin Tam', 'Initials': 'KT', 'LastName': 'Ashing', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Gwendolyn P', 'Initials': 'GP', 'LastName': 'Quinn', 'Affiliation': 'New York University, Grossman School of Medicine New York, New York, NY, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Vadaparampil', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1324']
3237,32940404,"The beneficial effects of sumac (Rhus coriaria L.) supplementation along with restricted calorie diet on anthropometric indices, oxidative stress, and inflammation in overweight or obese women with depression: A randomized clinical trial.","BACKGROUND


Oxidative stress and inflammation play pivotal roles in the pathophysiology of obesity and depression. This study aimed to evaluate the effects of sumac (Rhus coriaria L.) on anthropometric indices, oxidative stress, inflammation, and depression in overweight or obese depressed women.
METHODS


This randomized, double-blind, placebo-controlled clinical trial was conducted on overweight or obese women aged 20-65 years with mild to moderate depression. The participants (n = 62) were assigned to receive a restricted calorie diet (RCD) plus 3 g/day of either sumac or placebo for 12 weeks. Anthropometric measurements, biochemical biomarkers, and the Beck depression inventory were assessed during the study.
RESULTS


Sumac significantly reduced weight, body mass index, body fat (p < .001), visceral fat level (p = .03), waist and hip circumference, and malondialdehyde levels (p = .03, p = .002, and p = .006, respectively) in comparison with the placebo group. The levels of interleukin-6 and tumor necrosis factor-α decreased only in the sumac group (11 and 32%, respectively); however, these reductions were not significant. The high-sensitivity c-reactive protein levels (p = .007 and p = .01, respectively) and Beck scores (p < .001) decreased significantly in both the sumac and the placebo group without any significant difference between the two groups.
CONCLUSION


Sumac can be considered as a functional food that along with RCD could have beneficial effects on obesity management, through the possible modulatory effects on oxidative stress in overweight or obese depressed women.",2020,"The high-sensitivity c-reactive protein levels (p = .007 and p = .01, respectively) and Beck scores (p < .001) decreased significantly in both the sumac and the placebo group without any significant difference between the two groups.
","['participants (n =\u200962', 'overweight or obese depressed women', 'overweight or obese women with depression', 'overweight or obese women aged 20-65\u2009years with mild to moderate depression']","['sumac (Rhus coriaria L.) supplementation', 'placebo', 'sumac (Rhus coriaria L', 'restricted calorie diet (RCD) plus 3\u2009g/day of either sumac or placebo']","['weight, body mass index, body fat ', 'Anthropometric measurements, biochemical biomarkers, and the Beck depression inventory', 'anthropometric indices, oxidative stress, inflammation, and depression', 'waist and hip circumference, and malondialdehyde levels', 'high-sensitivity c-reactive protein levels', 'visceral fat level', 'oxidative stress', 'anthropometric indices, oxidative stress, and inflammation', 'levels of interleukin-6 and tumor necrosis factor-α', 'Beck scores']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0330866', 'cui_str': 'Coriaria'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.473491,"The high-sensitivity c-reactive protein levels (p = .007 and p = .01, respectively) and Beck scores (p < .001) decreased significantly in both the sumac and the placebo group without any significant difference between the two groups.
","[{'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Hariri', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Darafshi Ghahroudi', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Siroos', 'Initials': 'S', 'LastName': 'Jahangiri', 'Affiliation': 'Social Security Organization, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Borumandnia', 'Affiliation': 'Department of Basic Science, Faculty of Paramedical Sciences, Shahid Labbafinejad Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Narmaki', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atoosa', 'Initials': 'A', 'LastName': 'Saidpour', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6737']
3238,32941395,Redefining Therapeutic Drug Monitoring of Tacrolimus in Patients Undergoing Liver Transplantation: A Target Trough Concentration of 4-7 ng/mL During the First Month After Liver Transplantation is Safe and Improves Graft and Renal Function.,"BACKGROUND


Currently, the recommended tacrolimus (TAC) trough level (Cmin) after liver transplantation (LT) is 6-10 ng/mL (when associated in triple immunosuppressive therapy). However, few studies have achieved the lower limit of this range, especially below 7 ng/mL. This study evaluated the efficacy of a target TAC Cmin of 4-7 ng/mL after LT.
METHODS


Of 1677 LTs performed between 2002 and 2017, 904 LT cases were analyzed. The cases were categorized into the following 3 groups and compared: low- (n = 247, 27.3%), intermediate- (n = 344, 37.9%), and high-exposure groups (n = 313, 34.5%) with TAC Cmin of 4-7 ng/mL, 7-10 ng/mL, and >10 ng/mL, respectively. In addition, propensity score matching was performed to reduce heterogeneity and population bias.
RESULTS


At months 1 and 3, when compared with the 2 other groups, the low-exposure group had similar grafts (P = 0.75) and patient (P = 0.77) survival, but lower alanine aminotransferase (P < 0.001), bilirubin (P < 0.001), international normalized ratio (P = 0.046), and creatinine (P < 0.001) levels. After propensity score matching, the bilirubin (P < 0.001) and creatinine (P = 0.001) levels in the low-exposure group still improved at months 3, but the graft (P = 0.86) and patient (P = 0.99) survival were still similar.
CONCLUSIONS


A TAC Cmin of 4-7 ng/mL seems safe and capable of improving graft and kidney function. This finding should be confirmed in a prospective randomized trial.",2020,"After propensity score matching, the bilirubin (P < 0.001) and creatinine (P = 0.001) levels in the low-exposure group still improved at months 3, but the graft (P = 0.86) and patient (P = 0.99) survival were still similar.
","['Of 1677 LTs performed between 2002 and 2017, 904 LT cases were analyzed', 'Patients Undergoing Liver Transplantation']",['Tacrolimus'],"['international normalized ratio', 'bilirubin', 'alanine aminotransferase', 'Safe and Improves Graft and Renal Function', 'safe and capable of improving graft and kidney function']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.136658,"After propensity score matching, the bilirubin (P < 0.001) and creatinine (P = 0.001) levels in the low-exposure group still improved at months 3, but the graft (P = 0.86) and patient (P = 0.99) survival were still similar.
","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Lemaitre', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Tron', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Renard', 'Affiliation': 'CHU Rennes, Service de Chirurgie Hépatobiliaire et Digestive.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jézéquel', 'Affiliation': 'CHU Rennes, Service des Maladies du Foie.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Houssel-Debry', 'Affiliation': 'CHU Rennes, Service de Chirurgie Hépatobiliaire et Digestive.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bergeat', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Pastoret', 'Affiliation': ""CHU Rennes, Service d'Hématologie Cellulaire, Hémostase Bioclinique.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Collet', 'Affiliation': 'CHU Rennes, Service de Biochimie et Toxicologie.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Petitcollin', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Marie-Clémence', 'Initials': 'MC', 'LastName': 'Verdier', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Bardou-Jacquet', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Camus', 'Affiliation': 'INSERM, CIC 1414.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Boudjema', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bellissant', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rayar', 'Affiliation': 'Université Rennes1, Faculté de Médecine.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000779']
3239,32946885,Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course.,"Multimorbidity (MM) is a widespread problem and it poses unsolved issues like the healthcare professionals' training. A training curriculum has been proposed, but it has not been sufficiently explored in a clinical context. The eMULTIPAP course is part of the MULTIPAP complex intervention, applied through a pragmatic controlled, cluster randomized clinical trial to general practitioners (GP) and his/her patients with MM with 12 months follow-up. The eMULTIPAP course is based on problem-based learning, constructivism and Ariadne principles. It has been assessed according to the Kirkpatrick model and has shown knowledge improvement and high applicability of learning with more motivation to consider MM in the clinical practice. It has also improved the Medication Appropriateness Index at 6-months and at 12- months. We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",2020,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.",['general practitioners (GP) and his/her patients with MM with 12 months follow-up'],"['Multimorbidity (MM', 'eMULTIPAP']","['Medication Appropriateness Index', ""GP's learning""]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0184836,"We conclude that the eMULTIPAP course generates significant changes in GP's learning, enhancing clinical practice in multimorbidity scenarios.","[{'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: francisca.leiva.sspa@juntadeandalucia.es.'}, {'ForeName': 'Juan Daniel', 'Initials': 'JD', 'LastName': 'Prados-Torres', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain. Electronic address: juand.prados.sspa@juntadeandalucia.es.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Prados-Torres', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: sprados.iacs@aragon.es.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Del-Cura-González', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain. Electronic address: isabel.cura@salud.madrid.org.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Castillo-Jimena', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Coín, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: marcosc.malaga@gmail.com.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain; Public Health and Preventive Medicine Area, University Rey Juan Carlos, Madrid, Spain; Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: juanantonio.lopez@salud.madrid.org.'}, {'ForeName': 'Maria Eloísa', 'Initials': 'ME', 'LastName': 'Rogero-Blanco', 'Affiliation': 'Primary Care Health Centre General Ricardos, Madrid Health Service, Spain. Electronic address: mariaeloisa.rogero@salud.madrid.org.'}, {'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; Research Unit, Primary Health Care Management of Madrid, Madrid Health Service, Spain. Electronic address: cristinamaria.lozano@salud.madrid.org.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'López-Verde', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Primary Care Health Centre Las Delicias, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: flverde@gmail.com.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Bujalance-Zafra', 'Affiliation': 'Teaching Unit for Family and Community Primary Care Health District Málaga/Guadalhorce, Andalusian Health Service, Málaga, Spain; Biomedical Research Institute of Málaga -IBIMA-, University of Malaga, Spain; Primary Care Health Centre Victoria, Health District Málaga-Guadalhorce, Andalusian Health Service, Málaga, Spain. Electronic address: mjbujalance@hotmail.com.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Pico-Soler', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre Torrero-La Paz, Aragon Health Service, Zaragoza, Spain. Electronic address: vpico@salud.aragon.es.'}, {'ForeName': 'Luis Andrés', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain; Primary Care Health Centre San Pablo. Aragon Health Service, Zaragoza, Spain. Electronic address: lugifel@gmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Health Services and Chronic Conditions Research Network (REDISSEC), Health Institute Carlos III, Madrid, Spain; EpiChron Research Group, Aragon Health Sciences Institute (IACS), IIS Aragón, Miguel Servet University Hospital, Zaragoza, Spain. Electronic address: bpoblador.iacs@aragon.es.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martinez-Cañavate', 'Affiliation': 'IAVANTE: Línea de Formación de la Fundación Progreso y Salud, Junta de Andalucía, Spain. Electronic address: teresa.martinezcanavate@juntadeandalucia.es.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Johann Wolfgang Goethe University, Frankfurt, Germany. Electronic address: muth@allgemeinmedizin.uni-frankfurt.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Mechanisms of ageing and development,['10.1016/j.mad.2020.111354']
3240,32946924,"Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial.","BACKGROUND


Trophoblast cell-surface antigen-2 (Trop-2) is expressed in epithelial cancers, including hormone receptor-positive (HR+) metastatic breast cancer (mBC). Sacituzumab govitecan (SG; Trodelvy®) is an antibody-drug conjugate composed of a humanized anti-Trop-2 monoclonal antibody coupled to SN-38 at a high drug-to-antibody ratio via a unique hydrolyzable linker that delivers SN-38 intracellularly and in the tumor microenvironment. SG was granted accelerated FDA approval for metastatic triple-negative BC treatment in April 2020.
PATIENTS AND METHODS


We analyzed a prespecified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase I/II, single-arm trial (NCT01631552), who received intravenous SG (10 mg/kg) and whose disease progressed on endocrine-based therapy and at least one prior chemotherapy for mBC. End points included objective response rate (ORR; RECIST version 1.1) assessed locally, duration of response (DOR), clinical benefit rate, progression-free survival (PFS), overall survival (OS), and safety.
RESULTS


Fifty-four women were enrolled between 13 February 2015 and 1 June 2017. Median (range) age was 54 (33-79) years and all received at least two prior lines of therapy for mBC. At data cut-off (1 March 2019), 12 patients were still alive. Key grade ≥3 treatment-related toxicities included neutropenia (50.0%), anemia (11.1%), and diarrhea (7.4%). Two patients discontinued treatment due to treatment-related adverse events. No treatment-related deaths occurred. At a median follow-up of 11.5 months, the ORR was 31.5% [95% confidence interval (CI), 19.5%-45.6%; 17 partial responses]; median DOR was 8.7 months (95% CI 3.7-12.7), median PFS was 5.5 months (95% CI 3.6-7.6), and median OS was 12 months (95% CI 9.0-18.2).
CONCLUSIONS


SG shows encouraging activity in patients with pretreated HR+/HER2- mBC and a predictable, manageable safety profile. Further evaluation in a randomized phase III trial (TROPiCS-02) is ongoing (NCT03901339).
TRIAL REGISTRATION


ClinicalTrials.gov NCT01631552; https://clinicaltrials.gov/ct2/show/NCT01631552.",2020,No treatment-related deaths occurred.,"['Fifty-four women were enrolled between February 13, 2015 and June 1, 2017', 'We analyzed a pre-specified subpopulation of patients with HR+/human epidermal growth factor receptor 2-negative (HER2-) HR+/HER2- mBC from the phase 1/2, single-arm trial (NCT01631552), who received']","['Sacituzumab Govitecan', 'intravenous SG', 'endocrine-based therapy and at least one prior chemotherapy for mBC']","['diarrhea', 'ORR', '17 partial responses); median DOR', 'anemia', 'toxicities included neutropenia', 'median OS', 'median PFS', 'objective response rate (ORR: RECIST 1.1) assessed locally, duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C4086837', 'cui_str': 'sacituzumab govitecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",54.0,0.128403,No treatment-related deaths occurred.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kalinsky', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Columbia University Irving Medical Center-Herbert Irving Comprehensive Cancer Center, New York, USA. Electronic address: kk2693@cumc.columbia.edu.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Diamond', 'Affiliation': 'Department of Medicine, Medical Oncology, University of Colorado Cancer Center, Aurora, USA.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Vahdat', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology, Baylor University Medical Center, US Oncology, Dallas, USA.'}, {'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Moroose', 'Affiliation': 'Department of Hematology/Oncology, Orlando Health UF Health Cancer Center, Orlando, USA.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, USA.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Abramson', 'Affiliation': 'Department of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Goldenberg', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Sharkey', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Maliakal', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Hong', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goswami', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Wegener', 'Affiliation': 'Clinical Development, Immunomedics, Inc., Morris Plains, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Department of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.09.004']
3241,32946978,Sensory attributes of coated tablets: Developing a formal lexicon and sensory wheel.,"The patient's sensory experience when taking an oral medicine is important in the assessment of its palatability, and acceptability. The aim of this study was to develop tools useful for standardisation of sensory assessment of coated tablets: a lexicon and a sensory wheel. Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets. By adapting the principles used by food sciences, a free-text description of conventional, bitter-tasting or tasteless, coated tablets was performed. In the first assessment, volunteers described the sensory attributes of the first set of tablets. The attributes collected were then validated using a second set of tablets in a separate study with different volunteers. The appropriateness and semantics of each sensory attribute was analysed. Twenty attributes most relevant for assessment of coated tablets were selected for the lexicon and associated with explicit definitions. A collection of all attributes that could possibly be triggered by coated tablets were organised in the form of a sensory wheel. This study provides a valuable insight into the sensory experience while taking a coated tablet and presents tools which can accelerate the development of palatable medicines.",2020,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.",['52 heathy adult volunteers and two sets of coated tablets'],['coated tablets'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}]",[],,0.0459016,"Two randomised, double-blind sensory assessments were performed involving 83 and 52 heathy adult volunteers and two sets of coated tablets.","[{'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: hannah.batchelor@strath.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119883']
3242,32949568,Ambulatory Reflux Monitoring Guides Proton Pump Inhibitor Discontinuation in Patients With Gastroesophageal Reflux Symptoms: A Clinical Trial.,"BACKGROUND AND AIMS


Proton pump inhibitor (PPI) therapy fails to provide adequate symptom control in up to 50% of patients with gastroesophageal reflux symptoms. Although a proportion do not require ongoing PPI therapy, a diagnostic approach to identify candidates appropriate for PPI cessation is not available. This study aimed to examine the clinical utility of prolonged wireless reflux monitoring to predict the ability to discontinue PPIs.
METHODS


This double-blinded clinical trial performed over 3 years at 2 centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response. Participants underwent prolonged wireless reflux monitoring (off PPIs for ≥7 days) and a 3-week PPI cessation intervention. Primary outcome was tolerance of PPI cessation (discontinued or resumed PPIs). Symptom burden was quantified using the Reflux Symptom Questionnaire electronic Diary (RESQ-eD).
RESULTS


Of 128 enrolled, 100 participants met inclusion criteria (mean age, 48.6 years; 41 men). Thirty-four participants (34%) discontinued PPIs. The strongest predictor of PPI discontinuation was number of days with acid exposure time (AET) > 4.0% (odds ratio, 1.82; P < .001). Participants with 0 days of AET > 4.0% had a 10 times increased odds of discontinuing PPI than participants with 4 days of AET > 4.0%. Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD, -43.7% vs -5.3%; P = .04).
CONCLUSIONS


Among patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis, acid exposure on reflux monitoring predicted the ability to discontinue PPIs without symptom escalation. Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management. (ClinicalTrials.gov, Number: NCT03202537).",2020,"Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD: -43.7% vs -5.3%;p=0.04).
","['100 participants met inclusion criteria (mean age 48.6 years; 41 male', 'Of 128 enrolled', 'patients with gastroesophageal reflux symptoms', 'three years at two centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response', 'patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis']","['Proton pump inhibitor (PPI) therapy', 'prolonged wireless reflux monitoring', 'PUMP']","['tolerance of PPI cessation (discontinued or resumed PPI', 'Reflux Symptom Questionnaire electronic Diary (RESQ-eD', 'odds of discontinuing PPI', 'Reduction in symptom burden']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",128.0,0.0894531,"Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD: -43.7% vs -5.3%;p=0.04).
","[{'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Yadlapati', 'Affiliation': 'Division of Gastroenterology, University of California, San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Masihi', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'C Prakash', 'Initials': 'CP', 'LastName': 'Gyawali', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Dustin A', 'Initials': 'DA', 'LastName': 'Carlson', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kahrilas', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Billy Darren', 'Initials': 'BD', 'LastName': 'Nix', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Division of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Triggs', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Vaezi', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Kia', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kaizer', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado, Anschutz Medical Campus, Colorado School of Public Health, Aurora, Colorado.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pandolfino', 'Affiliation': 'Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address: j-pandolfino@northwestern.edu.'}]",Gastroenterology,['10.1053/j.gastro.2020.09.013']
3243,32949650,"Multimorbidity, glycaemic variability and time in target range in people with type 2 diabetes: A baseline analysis of the GP-OSMOTIC trial.","AIMS


To explore associations between multimorbidity condition counts (total; concordant (diabetes-related); discordant (unrelated to diabetes)) and glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR)) using data from a randomised controlled trial examining effectiveness of continuous glucose monitoring (CGM) in people with type 2 diabetes (T2D).
METHODS


Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring To Improve Clinical outcomes (GP-OSMOTIC) trial from 25 general practices in Australia. Number of long-term conditions (LTCs) in addition to T2D used to quantify total/concordant/discordant multimorbidity counts. GV (measured by coefficient of variation (CV)) and TIR derived from CGM data. Multivariable linear regression models used to examine associations between multimorbidity counts, HbA1c (%), GV and TIR.
RESULTS


Mean (SD) age of participants 60.4 (9.9) years; 40.9% female. Multimorbidity was present in 89.2% of participants. Most prevalent comorbid LTCs: hypertension (57.4%), painful conditions (29.8%), coronary heart disease (22.6%) and depression (19.0%). No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
CONCLUSIONS


While multimorbidity was common in this T2D cohort, it was not associated with HbA1c, CV or TIR. Future studies should explore factors other than glycaemia that contribute to the increased mortality observed in those with multimorbidity and T2D.",2020,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","['people with type 2 diabetes', 'Cross-sectional study: 279 people with T2D using baseline data from the General Practice Optimising Structured MOnitoring', 'Mean (SD) age of participants 60.4 (9.9) years; 40.9% female', '25 general practices in Australia', 'people with type 2 diabetes (T2D']",['continuous glucose monitoring (CGM'],"['Number of long-term conditions (LTCs', 'GV (measured by coefficient of variation (CV)) and TIR', 'coronary heart disease', 'multimorbidity counts, HbA1c, GV and TIR', 'glycaemia (HbA1c; glycaemic variability (GV); time in range (TIR', 'Multimorbidity', 'HbA1c, CV or TIR', 'Multimorbidity, glycaemic variability and time in target range', 'multimorbidity counts, HbA1c (%), GV and TIR', 'painful conditions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",279.0,0.207765,"No evidence of associations between multimorbidity counts, HbA1c, GV and TIR.
","[{'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Chiang', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia. Electronic address: jason.chiang@unimelb.edu.au.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Manski-Nankervis', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Sharmala', 'Initials': 'S', 'LastName': 'Thuraisingam', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': ""Department of Medicine, St Vincent's Hospital, University of Melbourne, Australia.""}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Mair', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Bhautesh Dinesh', 'Initials': 'BD', 'LastName': 'Jani', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'Barbara I', 'Initials': 'BI', 'LastName': 'Nicholl', 'Affiliation': 'General Practice and Primary Care, Institute of Health and Wellbeing, University of Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, University of Melbourne, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108451']
3244,32950613,A 4-week exercise and protein program improves muscle mass and physical functioning in older adults - A pilot study.,"BACKGROUND


Prehabilitation might attenuate common surgery-induced losses in muscle mass and physical performance. Beneficial effects of physical exercise with protein supplementation have been reported in older adults, but typically after an intervention of at least 12 weeks. The time-window for pre-surgery training is often limited to around 30 days, and it is not known if it is possible to achieve comparable results in such a short time window.
OBJECTIVES


The aim of this study was to pilot-test the effectiveness of a controlled four-week combined exercise and protein supplementation program on skeletal muscle-related outcomes in a Dutch older adult population.
DESIGN


This study was a one-armed pilot trial.
PARTICIPANTS


Seventeen older men and women, aged 55-75y, not scheduled for surgery.
INTERVENTION


A 4-week intervention program consisting of a twice-weekly supervised resistance and high-intensity aerobic exercise training of 75 min, combined with daily protein supplementation (2 doses of 15.5 g/day at breakfast and lunch).
MEASUREMENT


After two and four weeks, isometric quadriceps maximal voluntary contraction (MVC) was assessed via Biodex and quadriceps cross-sectional area (CSA) via magnetic resonance imaging. Other outcome measures were handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test.
RESULTS


Compliance to the supervised training sessions (99.3%) and the protein supplementation (97%) was very high. The 4-week exercise and protein program led to an increase in quadriceps CSA of 2.3 ± 0.7 cm 2  (P = 0.008) in the dominant leg and 3.2 ± 0.7 cm 2  (P < 0.001) in the non-dominant leg. Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003). Chair rise test time improved with -3.8 ± 0.5 s (P < 0.0001), and VO 2 -max improved with 3.3 ± 1.1 ml/min/kg (P = 0.014). We observed no changes in body weight and handgrip strength.
CONCLUSION


A 4-week exercise and protein intervention led to improvements in muscle-related outcomes in older adults with low levels of physical activity.",2020,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","['older adults', 'Seventeen older men and women, aged 55-75y, not scheduled for surgery', 'older adults with low levels of physical activity', 'Dutch older adult population']","['combined exercise and protein supplementation program', 'exercise and protein intervention', 'exercise and protein program', 'intensity aerobic exercise training of 75\u202fmin, combined with daily protein supplementation', 'physical exercise with protein supplementation']","['muscle mass and physical functioning', 'isometric quadriceps maximal voluntary contraction (MVC', 'Isometric quadriceps MVC', 'Chair rise test time', 'VO 2 -max', 'handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test', 'body weight and handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",17.0,0.0475282,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","[{'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Grootswagers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands. Electronic address: pol.grootswagers@wur.nl.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Regt', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Jacintha', 'Initials': 'J', 'LastName': 'Domić', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Dronkers', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands; Research group Innovation and Movement Care, University of Applied Science, Utrecht, the Netherlands.'}, {'ForeName': 'Marlieke', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Science Office, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands; Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}]",Experimental gerontology,['10.1016/j.exger.2020.111094']
3245,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES


Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS


In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS


Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS


The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS


Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2021,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
3246,32951780,"Red light: A novel, non-pharmacological intervention to promote alertness in shift workers.","INTRODUCTION


Night work requires inversion of the natural, diurnal human activity-rest cycle and is associated with decreased alertness and some measures of performance, reduced safety, adverse health effects, and chronic disruption of the melatonin cycle that has been associated with increased risk for several major diseases. Previous studies show that red light exposures at night can promote alertness and improve performance while not negatively affecting melatonin secretion.
METHOD


This ongoing crossover, mixed (within- and between-subjects) design field study is testing the efficacy and acceptance of red light delivered to day-shift and night-shift workers using personal light glasses while they are at work. Each participant experienced three lighting interventions at the eyes: red light (50 lx, 630 nm, the treatment intervention), blue light (50 lx, 460 nm, the positive control intervention), and dim white light (10 lx, 3,000 K, the placebo control). During the interventions, participants underwent visual performance testing, submitted salivary melatonin and cortisol samples, and provided subjective reports of sleepiness, sleep disturbance, and general health over the 20-week protocol. Due to the ongoing nature of the study, only the performance and subjective reports are presented here.
RESULTS


Preliminary results indicate that response times were improved by the red and blue interventions, but not accuracy and hit rates. Blue light was associated with improvements to self-reported sleep disturbances compared to dim light.
CONCLUSIONS


These field results partially support our laboratory results that showed a positive effect of red light for promoting alertness and certain performance outcomes during the day and at night. Practical Applications: Red light may be used to improve response times in shift workers. Continued research will elucidate the lighting interventions' effects on melatonin and objective sleep measures (actigraphy).",2020,"Blue light was associated with improvements to self-reported sleep disturbances compared to dim light.
",['shift workers'],"['lighting interventions at the eyes: red light (50\u202flx, 630\u202fnm, the treatment intervention), blue light (50\u202flx, 460\u202fnm, the positive control intervention), and dim white light', 'Red light']","['response times', 'sleep disturbances', 'accuracy and hit rates', 'melatonin and objective sleep measures (actigraphy']","[{'cui': 'C0425104', 'cui_str': 'Shift worker'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",3000.0,0.0148726,"Blue light was associated with improvements to self-reported sleep disturbances compared to dim light.
","[{'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, 21 Union Street, Troy, NY 12280, United States. Electronic address: figuem@rpi.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pedler', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, 21 Union Street, Troy, NY 12280, United States.'}]",Journal of safety research,['10.1016/j.jsr.2020.06.003']
3247,32951794,Efficacy of text messaging apprentices to reinforce ergonomics and safety voice training.,"INTRODUCTION


Injuries and work-related musculoskeletal disorders (MSDs) are common among masons. SAfety Voice for Ergonomics (SAVE) integrates training in ergonomic and safety problem-solving skills into masonry apprenticeship training. The purpose of this study was to assess the efficacy of text messaging to reinforce SAVE program content.
METHOD


SAVE effectiveness was evaluated at masonry apprenticeship training centers across the United States by comparing three experimental groups: (1) Ergonomics training, (2) Ergonomics and Safety Voice training, and a (3) Control. Apprentices received SAVE training with their standard instruction. To reinforce classroom training, refresher training was implemented by sending weekly text messages for six months. Half of the text messages required a response, which tested knowledge or assessed behavior, while the remaining reiterated knowledge. Apprentices (n = 119) received SAVE text messages. Response rates and percentage of correct responses were compared with chi-square tests and independent group t-tests. Multivariable logistic regression analysis predicted apprentice response with selected demographic and work experience variables. Finally, feedback on of the use of text messaging was obtained.
RESULT


Of 119 participants, 61% (n = 72) responded to at least one text message. Logistic regression revealed that being a high school graduate and a brick and block mason significantly affected the odds of responding. Sixty-nine percent of apprentices agreed that text messages reinforced SAVE content.
CONCLUSION


Even though there was no training center requirement to respond, the high response rate suggests that text messaging can effectively be used to reinforce ergonomics and safety voice training for both knowledge and behavior. Practical Application: The prevalent use of text messaging creates opportunities to reinforce health and safety training and engage workers, especially for populations that may be at various locations over time such as construction sites. Instructors and practitioners should consider the utility of text messaging for supporting their training and safety programs.",2020,Logistic regression revealed that being a high school graduate and a brick and block mason significantly affected the odds of responding.,[],"['SAVE text messages', 'SAVE training with their standard instruction', 'Ergonomics training, (2) Ergonomics and Safety Voice training, and a (3) Control']",['Response rates and percentage of correct responses'],[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042944', 'cui_str': 'Voice training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",119.0,0.0238435,Logistic regression revealed that being a high school graduate and a brick and block mason significantly affected the odds of responding.,"[{'ForeName': 'Laurel D', 'Initials': 'LD', 'LastName': 'Kincl', 'Affiliation': 'College of Public Health and Human Sciences, Oregon State University, Corvallis, OR, USA. Electronic address: laurel.kincl@oregonstate.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Hess', 'Affiliation': 'Labor Education and Research Center, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Weeks', 'Affiliation': ""Department of Rehabilitation Research, St. Luke's Rehabilitation Institute, Spokane, WA, USA.""}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': 'College of Public Health and Human Sciences, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Anton', 'Affiliation': 'Department of Physical Therapy, Eastern Washington University, Spokane, WA, USA.'}]",Journal of safety research,['10.1016/j.jsr.2020.04.007']
3248,32986227,"Correction to: Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled Trial.","In the original publication, the Second author name was incorrectly published as Marcos Perez III.",2020,"In the original publication, the Second author name was incorrectly published as Marcos Perez III.",[],['Bacillus clausii Capsules'],['Adverse Effects'],[],"[{'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.359787,"In the original publication, the Second author name was incorrectly published as Marcos Perez III.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Plomer', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.'}, {'ForeName': 'Marcos Iii', 'Initials': 'MI', 'LastName': 'Perez', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.'}, {'ForeName': 'Dorothea Maren', 'Initials': 'DM', 'LastName': 'Greifenberg', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany. Dorothea.Greifenberg@sanofi.com.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00346-x']
3249,32980586,Desire to drink as a function of laboratory-induced social stress among adolescents.,"BACKGROUND AND OBJECTIVES


Research consistently demonstrates a link between social anxiety and alcohol-related problems; however, the majority of work has been retrospective, and conducted with adults. Despite an extensive literature highlighting coping-related motives as an underlying mechanism, real-time work presents mixed findings, and no published research has examined an adolescent sample using experimental psychopathology techniques.
METHODS


The current study tested whether (1) history of social anxiety symptoms positively correlated with alcohol-related cognitions following laboratory-induced social stress, (2) state anxiety was positively correlated with alcohol-related cognitions, and (3) whether the nature of the stressor (performance versus rejection) impacted the strength of identified relations, in a sample of community-recruited adolescents reporting recent alcohol use. Participants (n = 114; M age  = 16.01; 64% girls) were randomly assigned to either a performance- or rejection-oriented task.
RESULTS


Findings indicated that history of social anxiety symptoms was positively correlated with state anxiety elicited by both tasks. Further, history of social anxiety symptoms was not related to change in desire to drink, but was positively related to the belief that alcohol 'would make me feel better.' State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks. Finally, the nature of the task did not moderate responding.
LIMITATIONS


Single site, community sampling confines interpretations, and the tasks did not fully perform as expected.
CONCLUSIONS


Further study is needed; however, the current findings support the contention that socially-oriented distress may be a developmentally-relevant, malleable target for prevention efforts aimed at problematic alcohol use among adolescents.",2021,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"['114; M age \xa0=\xa016.01; 64% girls', 'adolescents', 'Participants (n\xa0']",['performance- or rejection-oriented task'],"['history of social anxiety symptoms', 'State anxiety']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}]","[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0194071,State anxiety was positively related to both desire to drink and relief outcome expectancies across both tasks.,"[{'ForeName': 'Heidemarie', 'Initials': 'H', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: heidemarie.blumenthal@unt.edu.'}, {'ForeName': 'Renee M', 'Initials': 'RM', 'LastName': 'Cloutier', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: ReneeCloutier@my.unt.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Douglas', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: MeganDouglas@my.unt.edu.'}, {'ForeName': 'Nathan T', 'Initials': 'NT', 'LastName': 'Kearns', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: NathanKearns@my.unt.edu.'}, {'ForeName': 'Caitlyn N', 'Initials': 'CN', 'LastName': 'Carey', 'Affiliation': 'Department of Psychology, University of North Texas, 1155 Union Circle #311280, Denton, TX, 76203, United States. Electronic address: CaitlynCarey@my.unt.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101617']
3250,32980764,Comparative dose-response study of hyperbaric ropivacaine for spinal anesthesia for cesarean delivery in singleton versus twin pregnancies.,"STUDY OBJECTIVE


It is controversial whether local anesthetic dose requirement for spinal anesthesia for cesarean delivery differs between patients with singleton and patients with multiple gestation pregnancies. The aim of this study was to determine and compare the ED 50  and ED 90  for hyperbaric ropivacaine used for spinal anesthesia for cesarean delivery in patients with singleton pregnancies versus patients with twin pregnancies.
DESIGN


Prospective, randomized, comparative dose-finding study.
SETTING


Operating room, Women's Hospital, Zhejiang University School of Medicine.
PATIENTS


100 patients with singleton pregnancies (Group S) and 100 patients with twin pregnancies (Group T) presenting for scheduled cesarean delivery under combined spinal-epidural anesthesia were enrolled in the study.
INTERVENTIONS


Patients in Group S or Group T were randomly allocated to receive 9.5, 11, 12.5, 14 or 15.5 mg of hyperbaric ropivacaine intrathecally. A dose was considered effective when it achieved a bilateral sensory block level at the T6 dermatome or above within 10 min after intrathecal injection, there was no numerical rating scale (NRS) pain score ≥ 3 intraoperatively, and there was no requirement for epidural supplementation at any time during anesthesia and operation. Values for ED 50  and ED 90  for ropivacaine were determined using probit regression. The difference in ropivacaine dose requirement between patients with singleton pregnancies and patients with twin pregnancies was assessed by calculating relative median potency.
MEASUREMENTS


Success rates for different intrathecal doses of ropivacaine, side effects and neonatal outcomes were recorded.
MAIN RESULTS


The estimated (95% confidence interval) values for ED 50  and ED 90  of intrathecal ropivacaine in patients with singleton pregnancies were 11.2 (10.2 to 12.0) mg and 15.7 (14.4 to 18.3) mg, respectively. The values for ED 50  and ED 90  in patients with twin pregnancies were 10.5 (9.5 to 11.3) mg and 14.8 mg (13.6 to 17.0) mg, respectively. The estimate of relative median potency for ropivacaine between patients with singleton and twin pregnancies was 0.94 (95% confidence interval 0.83 to 1.04).
CONCLUSION


Patients with singleton and twin pregnancies have similar dose requirement for hyperbaric ropivacaine used for spinal anesthesia for cesarean delivery in the setting of combined spinal-epidural (CSE) anesthesia, no opioids, low weight cohort, insertion with the patients in the right lateral position, and norepinephrine boluses.",2020,"The estimated (95% confidence interval) values for ED 50  and ED 90  of intrathecal ropivacaine in patients with singleton pregnancies were 11.2 (10.2 to 12.0) mg and 15.7 (14.4 to 18.3) mg, respectively.","['100 patients with singleton pregnancies (Group S) and 100 patients with twin pregnancies (Group T) presenting for scheduled cesarean delivery under combined spinal-epidural anesthesia were enrolled in the study', 'Patients with singleton and twin pregnancies', 'patients with singleton pregnancies versus patients with twin pregnancies', 'spinal anesthesia for cesarean delivery in singleton versus twin pregnancies', 'patients with singleton and patients with multiple gestation pregnancies', 'patients with singleton and twin pregnancies', 'patients with singleton pregnancies and patients with twin pregnancies', ""Operating room, Women's Hospital, Zhejiang University School of Medicine""]","['ropivacaine', 'hyperbaric ropivacaine', 'intrathecal ropivacaine', 'spinal anesthesia', 'hyperbaric ropivacaine intrathecally', 'Patients in Group S or Group T']","['numerical rating scale (NRS) pain score', 'side effects and neonatal outcomes', 'bilateral sensory block level', 'relative median potency']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0036669', 'cui_str': 'Group T'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",100.0,0.0877961,"The estimated (95% confidence interval) values for ED 50  and ED 90  of intrathecal ropivacaine in patients with singleton pregnancies were 11.2 (10.2 to 12.0) mg and 15.7 (14.4 to 18.3) mg, respectively.","[{'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology, Zhejiang Xiaoshan Hospital, Hangzhou, China.""}, {'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anesthesiology, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Sheng', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Zhan-Huai', 'Initials': 'ZH', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Chang-Cheng', 'Initials': 'CC', 'LastName': 'Lyu', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Xin-Zhong', 'Initials': 'XZ', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address: qianxw@zju.edu.cn.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110068']
3251,32981123,The Effects of a Brief Motivational Intervention for Alcohol Use through Stages of Change among Nontreatment Seeking Injured Patients.,"BACKGROUND


Little is known about the mechanisms of change underlying brief interventions and the patient characteristics that may affect them. The present study tested whether the stages of change mediate the effects of a BMI with and without a telephone booster relative to brief advice (i.e., multiple mediation). Further, the present study tested whether the effects of the BMI conditions on the stages of change were contingent on patients' alcohol use severity (i.e., moderated mediation).
METHODS


The present study is a secondary analysis using data from injured adult patients at 3 trauma centers who were screened for inclusion in the study and randomly assigned to brief advice (n = 200), BMI (n = 203), or BMI with a telephone booster (n = 193) (Field et al., 2014). Participants completed a baseline assessment and 3-, 6-, and 12-month follow-up assessments that included self-report measures of the stages of change, alcohol use, and alcohol-related problems, as well as other variables of interest.
RESULTS


The results demonstrated significant and consistent mediation at p < 0.05 wherein BMI with a telephone booster increased action at 3-month follow-up leading to reduced likelihood of at-risk drinking, less alcohol use, and fewer alcohol problems at both 6- and 12-month follow-up. However, moderated mediation analyses suggested that the effects of the BMI conditions on the stages of change were not contingent on patients' alcohol use severity.
CONCLUSIONS


This study contributes to the understanding of stages of change as potential mechanisms of change in BMI. Directions for future research are discussed.",2020,"The results demonstrated significant and consistent mediation at p < .05 wherein BMI with a telephone booster increased action at 3-month follow-up leading to reduced likelihood of at-risk drinking, less alcohol use, and fewer alcohol problems at both 6- and 12-month follow-up.","['injured adult patients at three trauma centers who were screened for inclusion in the study and randomly assigned to brief advice (n = 200), BMI (n = 203), or', 'Non-Treatment Seeking Injured Patients']","['Brief Motivational Intervention', 'BMI with a telephone booster']",['alcohol problems'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]",,0.0195696,"The results demonstrated significant and consistent mediation at p < .05 wherein BMI with a telephone booster increased action at 3-month follow-up leading to reduced likelihood of at-risk drinking, less alcohol use, and fewer alcohol problems at both 6- and 12-month follow-up.","[{'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'From the, Department of Psychology, (CAF), Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, El Paso, Texas, USA.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Center on Alcohol, Substance use, And Addictions, (DKR), University of New Mexico, Albuquerque, New Mexico, USA.'}, {'ForeName': 'Yessenia', 'Initials': 'Y', 'LastName': 'Castro', 'Affiliation': 'Steve Hicks School of Social Work, (YC, KS), University of Texas at Austin, Texas, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Alonso Cabriales', 'Affiliation': 'Arts and Sciences Division, (JAC), University of New Mexico-Gallup, Gallup, New Mexico, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wagler', 'Affiliation': 'Department of Mathematical Science, (AW), University of Texas at El Paso El Paso, Texas, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'von Sternberg', 'Affiliation': 'Steve Hicks School of Social Work, (YC, KS), University of Texas at Austin, Texas, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14466']
3252,32989771,A randomized clinical trial of a virtual-training program for teaching applied-behavior-analysis skills to parents of children with autism spectrum disorder.,"Parents play an important role in the treatment of their children's symptoms of autism spectrum disorder (ASD); thus, developing effective, efficient, socially acceptable, and accessible procedures for training parents to implement applied-behavior-analysis (ABA) interventions is critically important. One potential approach involves delivering training via a virtual private network (VPN) over the internet (Fisher et al., 2014). In this study, we conducted a randomized clinical trial to evaluate a virtual parent-training program with e-learning modules and scripted role-play via a VPN. We evaluated parent implementation of ABA skills using direct-observation measures in structured-work and play-based training contexts. Parents in the treatment group showed large, statistically significant improvements on all dependent measures; those in the waitlist-control group did not. Parents rated the training as highly socially acceptable. Results add to the growing literature on the efficacy and acceptability of virtually delivered training in ABA.",2020,"Parents in the treatment group showed large, statistically significant improvements on all dependent measures; those in the waitlist-control group did not.","['parents of children with autism spectrum disorder', ""children's symptoms of autism spectrum disorder (ASD""]","['virtual-training program', 'virtual parent-training program with e-learning modules and scripted role-play via a VPN']",['efficacy and acceptability'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0179069,"Parents in the treatment group showed large, statistically significant improvements on all dependent measures; those in the waitlist-control group did not.","[{'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Fisher', 'Affiliation': 'Rutgers University Robert Wood Johnson Medical School.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Luczynski', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Blowers', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Vosters', 'Affiliation': 'University of Houston, Clear Lake.'}, {'ForeName': 'Maegan D', 'Initials': 'MD', 'LastName': 'Pisman', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Andy R', 'Initials': 'AR', 'LastName': 'Craig', 'Affiliation': 'Upstate Medical Center.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Hood', 'Affiliation': 'Marquette University.'}, {'ForeName': 'Mychal A', 'Initials': 'MA', 'LastName': 'Machado', 'Affiliation': 'University of Alaska Anchorage.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Lesser', 'Affiliation': ""The University of Nebraska Medical Center's Monroe-Meyer Institute.""}, {'ForeName': 'Cathleen C', 'Initials': 'CC', 'LastName': 'Piazza', 'Affiliation': 'Rutgers University School of Applied and Professional Psychology.'}]",Journal of applied behavior analysis,['10.1002/jaba.778']
3253,32990231,[Effect of Straumann implant on crown appearance in immediate implant restoration of maxillary anterior teeth].,"OBJECTIVE


To investigate the effect of Straumann implant on crown appearance in the immediate implant restoration of maxillary anterior teeth.
METHODS


This study was conducted among 86 patients undergoing immediate implant restoration of maxillary anterior teeth between January and December, 2018. We randomized the patients into control group for treatment with immediate implant restoration and study group receiving additional Straumann implant. The effects of restoration, bone absorption at 6 months, implant length, implant diameter, root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve were compared between the two groups.
RESULTS


The repair effect in the study group was better than that in the control group ( P  < 0.05). The implant length and implant diameter were significantly greater in the study group than in the control group. The root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve were all better in the study group. The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
CONCLUSIONS


Straumann implant can be used in immediate implant restoration of maxillary anterior teeth to achieve a better aesthetic effect.",2020,"The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
","['86 patients undergoing immediate implant restoration of maxillary anterior teeth between January and December, 2018', 'maxillary anterior teeth']","['immediate implant restoration and study group receiving additional Straumann implant', 'Straumann implant']","['bone absorption at 6 months, implant length, implant diameter, root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve', 'implant length and implant diameter', 'root protrusion, gingival color, far and middle gingival papilla, lip side gingival height, near and middle gingival papilla, and lip side gingival curve', 'repair effect', 'height of marginal bone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",86.0,0.0218608,"The height of marginal bone in the study group was significantly higher than that in the control group ( P  < 0.05).
","[{'ForeName': 'Zhongxiong', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Stomatological Hospital of Southern Medical University, Guangzhou 510220, China.'}, {'ForeName': 'Shaoqun', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Stomatology, Guangzhou Hospital of Integrated Traditional and West Medicine, Guangzhou 510800, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.09.22']
3254,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND


The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS


Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS


In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS


The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS


The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
3255,32959458,Hypersensitivity to Calcitonin Gene-Related Peptide in Post-Traumatic Headache.,"OBJECTIVE


To demonstrate that calcitonin gene-related peptide (CGRP) induces headache exacerbation with migraine-like features in patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI).
METHODS


A randomized, double-blind, placebo-controlled, two-way crossover study was conducted. Analyses were intention-to-treat. Eligible patients were aged 18 to 65 years and had a history of persistent PTH after mild TBI for at least 12 months. Patients were randomized to receive an intravenous infusion of 1.5μg/min of CGRP or placebo (isotonic saline) over 20 minutes on two separate experimental days. A 12-hour observational period was used to evaluate the following outcomes: (1) difference in incidence of headache exacerbation with migraine-like features and (2) difference in area under the curve for headache intensity scores.
RESULTS


Thirty patients (mean age = 37 years, 25 women [83%]) were randomized and completed the study. During the 12-hour observational period, 21 of 30 patients (70%) developed headache exacerbation with migraine-like features after CGRP, compared with 6 patients (20%) after placebo (p < 0.001). The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (p < 0.001).
INTERPRETATION


Patients with persistent PTH are hypersensitive to CGRP, which underscores its pathophysiological importance. Furthermore, CGRP-targeted therapies might provide a novel mechanism-based treatment option for patients with persistent PTH. ANN NEUROL 2020;88:1220-1228.",2020,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","['Thirty patients (mean age, 37\u2009years; 25 women [83', 'Eligible patients were aged 18 to 65\u2009years and had a history of persistent PTH after mild TBI for at least 12\u2009months', 'patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI', 'patients with persistent PTH']","['placebo', 'Calcitonin Gene-Related Peptide', 'calcitonin gene-related peptide (CGRP', 'intravenous infusion 1.5\u2009μg/min of CGRP or placebo (isotonic saline']","['headache intensity scores', 'headache exacerbation with migraine-like features, 2) difference in area under the curve for headache intensity scores', 'headache exacerbation with migraine-like features']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.678888,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Haidar M', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik W', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Annals of neurology,['10.1002/ana.25915']
3256,32959761,Waterless Hand Cleansing with Chlorhexidine during the Neonatal Period by Mothers and Other Household Members: Findings from a Randomized Controlled Trial.,"Observational data suggest maternal handwashing with soap prevents neonatal mortality. We tested the impact of a chlorhexidine-based waterless hand cleansing promotion on the behavior of mothers and other household members. In rural Bangladesh in 2014, we randomized consenting pregnant women to chlorhexidine provision and hand cleansing promotion or standard practices. We compared hand cleansing with chlorhexidine or handwashing with soap before baby care, among mothers and household members in the two groups, and measured chlorhexidine use in the intervention arm. Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes. Hand cleansing before baby care was observed 5.6 times more frequently among mothers in the intervention arm than in the controls (95% CI = 4.0-7.7). Hand cleansing was significantly more frequently observed in the intervention arm among women other than the mother (RR = 10.9) and girls (RR = 37.0). Men and boys in the intervention arm cleansed hands before 29% and 44% of baby care events, respectively, compared with 0% in the control arm. The median number of grams consumed during the neonatal period was 176 (IQR = 95-305 g), about 7.8 g/day (IQR = 4.2-13.8 g). Promotion of waterless chlorhexidine increased hand cleansing behavior among mothers and other household members. Discrepancy between observed use and measured chlorhexidine consumption suggested courtesy bias in structured observations. A waterless hand cleanser may represent one component of the multimodal strategies to prevent neonatal infections in low-resource settings.",2020,"Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes.","['Mothers and Other Household Members', 'mothers and other household members', ""baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes""]","['chlorhexidine', 'Chlorhexidine', 'chlorhexidine provision and hand cleansing promotion or standard practices', 'chlorhexidine-based waterless hand cleansing promotion']","['hand cleansing behavior', 'median number of grams consumed during the neonatal period', 'Hand cleansing', 'neonatal mortality']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.0768261,"Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes.","[{'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Begum', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Crabtree-Ide', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Mohammad Rofi', 'Initials': 'MR', 'LastName': 'Uddin', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Weaver', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Dostogir Harun', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Jelena V', 'Initials': 'JV', 'LastName': 'Allen', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Sharifa', 'Initials': 'S', 'LastName': 'Nasreen', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Shams', 'Initials': 'S', 'LastName': 'El Arifeen', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0773']
3257,32965659,Long-Term Ivacaftor in People Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations.,"INTRODUCTION


Mutations in the cystic fibrosis transmembrane conductance regulator gene (CFTR) affect the quantity and/or function of CFTR protein reaching the cell surface. Ivacaftor, a CFTR potentiator that enhances chloride transport, increases the channel-open probability of normal and dysfunctional CFTR. Initially approved for people with CF (pwCF) with G551D-CFTR gating mutations, ivacaftor demonstrated clinical benefit in pwCF with other gating mutations and certain residual function mutations, including R117H-CFTR, in clinical studies. We evaluated the long-term safety and efficacy of ivacaftor in pwCF aged 6 years and older with non-G551D-CFTR ivacaftor-responsive mutations.
METHODS


Efficacy and safety data from a phase 3, multicenter, open-label, extension study for participants from Study 110 (R117H-CFTR mutations), Study 111 (non-G551D-CFTR gating mutations), and Study 113 (n-of-1 pilot study in participants with residual CFTR function) were analyzed. Following washout from the randomized parent study, participants received oral ivacaftor 150 mg once every 12 h for 104 weeks.
RESULTS


Forty-one of 121 participants completed treatment through 104 weeks; 59 participants who did not complete the extension study continued treatment with commercial ivacaftor. The most common adverse events were pulmonary exacerbation (46.3%) and cough (33.9%). Most treatment-emergent adverse events were mild/moderate in severity and consistent with manifestations of CF or the ivacaftor safety profile. Rapid, durable improvement occurred across all efficacy endpoints.
CONCLUSIONS


Ivacaftor was generally safe and well tolerated with no new safety concerns for up to 104 weeks in pwCF with ivacaftor-responsive mutations. The pattern of improvement across efficacy endpoints was durable and generally consistent with parent-study outcomes.
TRIAL REGISTRATION


NCT01707290.",2020,"CONCLUSIONS


Ivacaftor was generally safe and well tolerated with no new safety concerns for up to 104 weeks in pwCF with ivacaftor-responsive mutations.","['Forty-one of 121 participants completed treatment through 104\xa0weeks; 59 participants who did not complete the extension study continued treatment with commercial ivacaftor', 'People', 'Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations', 'pwCF aged 6\xa0years and older with non-G551D-CFTR ivacaftor-responsive mutations', 'participants from Study 110 (R117H-CFTR mutations), Study 111 (non-G551D-CFTR gating mutations), and Study 113 (n-of-1 pilot study in participants with residual CFTR function']","['oral ivacaftor', 'ivacaftor']","['cough', 'safe and well tolerated']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}]",121.0,0.0483752,"CONCLUSIONS


Ivacaftor was generally safe and well tolerated with no new safety concerns for up to 104 weeks in pwCF with ivacaftor-responsive mutations.","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Pilewski', 'Affiliation': 'University of Pittsburgh, UPMC Montefiore Hospital, NW628, 3459 Fifth Ave, Pittsburgh, PA, 15213, USA. pilewskijm@upmc.edu.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'Faculty of Medicine, University Hospital of Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Nick', 'Affiliation': 'National Jewish Health, 1400 Jackson St, Denver, CO, 80206, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Ave, Boston, MA, 02210, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Ave, Boston, MA, 02210, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Higgins', 'Affiliation': 'Vertex Pharmaceuticals (Europe) Limited, 2 Kingdom St, London, W2 6BD, UK.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Moss', 'Affiliation': 'Center of Excellence in Pulmonary Biology, Stanford University School of Medicine, 770 Welch Rd #350, Palo Alto, CA, 94304, USA.'}]",Pulmonary therapy,['10.1007/s41030-020-00129-2']
3258,32960536,Does the Treatment After Kasai Procedure Influence Biliary Atresia Outcome and Native Liver Survival?,"OBJECTIVES


Biliary atresia (BA) is a rare and progressive idiopathic disease affecting the biliary tract that can lead to end-stage liver disease. The main treatment is Kasai portoenterostomy (KP). The use of adjuvant therapy (AT; prophylactic antibiotics and steroids) after KP aims to prevent cholangitis and reduce the need for liver transplantation (LT), but there is a lack of evidence on their effectiveness. We investigated the impact of significant changes in the post-KP protocol on the overall outcomes of BA.
METHODS


We enrolled 43 consecutive infants undergoing KP at Bambino Gesù Children's Hospital between July 2012 and October 2018. We compared AT (AT group; n=25) against no treatment (AT-free group; n = 18).
RESULTS


No significant differences in anthropometric and laboratory parameters were shown between the 2 groups at baseline and every study evaluation (1, 3, and 6 months). The incidences of clinical complications of liver disease were similar. Six months post-KP, the achievement of serum total bilirubin ≤1.5 mg/dL and satisfactory Pediatric End-Stage Liver Disease scores were not significantly different between the 2 groups. Cholangitis was observed in 30% of patients in the first 6 months postoperatively: 33% and 28% in the AT-free and AT groups, respectively (P = 0.18). Survival to LT listing at 12 months and without LT at 24 months were not significantly different between the 2 groups (P > 0.05).
CONCLUSIONS


AT after KP confirmed conflicting results; therefore, multicentered, prospective, randomized control studies are needed to better understand its utility after KP, especially in the multidrug resistance spread era.",2020,"Survival to LT listing at 12 months and without LT at 24 months were not significantly different between the 2 groups (P > 0.05).
","[""43 consecutive infants undergoing KP at Bambino Gesù Children's Hospital between July 2012 and October 2018""]",['adjuvant therapy (AT; prophylactic antibiotics and steroids'],"['serum total bilirubin', 'Survival to LT listing', 'anthropometric and laboratory parameters', 'Biliary Atresia Outcome and Native Liver Survival', 'satisfactory Pediatric End-Stage Liver Disease scores', 'clinical complications of liver disease', 'Cholangitis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032722', 'cui_str': 'Hepatic portoenterostomy'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005411', 'cui_str': 'Congenital biliary atresia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C4316678', 'cui_str': 'Pediatric end stage liver disease score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}]",43.0,0.0668329,"Survival to LT listing at 12 months and without LT at 24 months were not significantly different between the 2 groups (P > 0.05).
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pietrobattista', 'Affiliation': ""*Department of Hepatology, Gastroenterology and Nutrition †Division of Abdominal Transplantation and Hepatobiliopancreatic Surgery, Bambino Gesù Children's Hospital IRCCS, 00165 Rome, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Mosca', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Liccardo', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Alterio', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Grimaldi', 'Affiliation': ''}, {'ForeName': 'MariaSole', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Saffioti', 'Affiliation': ''}, {'ForeName': 'Claudia Della', 'Initials': 'CD', 'LastName': 'Corte', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spada', 'Affiliation': ''}, {'ForeName': 'Manila', 'Initials': 'M', 'LastName': 'Candusso', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002837']
3259,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND


This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS


Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS


Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
LIMITATIONS


Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS


Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
3260,32962055,"Breastfeeding at 1, 3 and 6 Months after Birth According to the Mode of Birth: A Correlation Study.","BACKGROUND


Breastfeeding is a determinant of child and maternal health. However, evidence is limited on how mode of birth influences breastfeeding. Research aim: To examine the mode of birth and breastfeeding duration and the type of lactation at one, three and six months after birth in XXX, during 2017.
METHODS


Correlation study on breastfeeding duration and type of lactation during the six months after birth, and mode of birth, in a randomised sample. Women ≥18 years of age with term singleton infants, were included. Collected data through interviews and hospital records. Pearson's and Spearman's correlation analyses were conducted. SPSSv21 and α = 0.05 were used.
RESULTS


Breastfeeding duration was shorter in women with greater parity (-0.055 **) ( p  < 0.01) and epidural analgesia (0.057 **) ( p  < 0.01), and longer in mothers with episiotomy (-0.267 **) ( p  < 0.01). Episiotomy was associated with breastfeeding at one month (0.112 **) ( p  < 0.01), and at six months (0.347 *) ( p  < 0.01). The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140 **) ( p  < 0.01) and higher at six months (0.013 **) ( p  < 0.01). The percentages of breastfeeding at three months were significantly greater in women with no perineal tears (2.1) ( p  < 0.05). At six months, small rates of breastfeeding were found in women with greater parity (0.051 **) ( p  < 0.01). No significant association was detected, neither between the type of lactation and the mode of birth, nor between breastfeeding duration and the mode of birth.
CONCLUSIONS


Epidural analgesia, episiotomy, perineal tears and parity influence the type of lactation and duration of breastfeeding during the six months after birth. The results suggest no association between the type of lactation and the mode of birth or between breastfeeding duration and the mode of birth.",2020,The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140,"['women with greater parity ', 'Women ≥18 years of age with term singleton infants']",['epidural analgesia'],"['small rates of breastfeeding', 'Episiotomy', 'percentages of breastfeeding', 'type of lactation and the mode of birth, nor between breastfeeding duration and the mode of birth', 'epidural analgesia', 'prevalence of breastfeeding']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0335807,The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Agea-Cano', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Linares-Abad', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio Gregorio', 'Initials': 'AG', 'LastName': 'Ceballos-Fuentes', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Calero-García', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186828']
3261,32962057,Effects of Simulation Practicum Using Flipped Learning for Korean Nursing Students.,"This study aimed to examine the effects of simulation practicum using flipped learning on nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and learning satisfaction of Korean nursing students. This study used a quasi-experimental pretest-posttest control group design. The samples used were from 101 nursing students (Intervention 1:  n  = 34; Intervention 2:  n  = 34; Control:  n  = 33) over 20 years old in G provinces, Korea. For the experimental interventions, participants in the intervention group 1 were applied by simulation practicum using flipped learning, and those in intervention group 2 were applied by simulation practicum. Participants in the control group were applied by lecture-based practicum using a model. The measures were the study participants' general characteristics survey, the nursing competency scale, the core basic nursing skill (subcutaneous injection) performance scale, the self-efficacy scale, and the learning satisfaction scale. There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups. It was seen in this study that simulation practicum using flipped learning was the most effective teaching and learning method for the nursing practicum of Korean nursing students. The simulation practicum using flipped learning can be useful in providing nursing practicum to nursing students.",2020,"There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups.","['101 nursing students (Intervention 1:  n  = 34', 'Korean Nursing Students', 'Korean nursing students']","['Intervention 2:  n  = 34; Control:  n  = 33) over 20 years old in G provinces, Korea', 'Simulation Practicum Using Flipped Learning', 'simulation practicum using flipped learning', 'simulation practicum using flipped learning, and those in intervention group 2 were applied by simulation practicum']","['nursing competency scale, the core basic nursing skill (subcutaneous injection) performance scale, the self-efficacy scale, and the learning satisfaction scale', 'nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction', 'nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and learning satisfaction']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",101.0,0.0135524,"There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups.","[{'ForeName': 'Minkyung', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Department of Nursing, College of Science and Technology, Daejin University, Pocheon-si, Gyeonggi-do 11159, Korea.'}, {'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul 02447, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186829']
3262,32962422,The Effect of Transcranial Pulsed Current Stimulation at 4 and 75 Hz on Electroencephalography Theta and High Gamma Band Power: A Pilot Study.,"Introduction:  Transcranial pulsed current stimulation (tPCS) is an emerging noninvasive brain stimulation technique that has shown significant effects on cortical excitability. To date, electrophysiological measures of the efficiency of monophasic tPCS have not been reported.  Objective:  We aimed to explore the effects of monophasic anodal and cathodal-tPCS (a-tPCS/c-tPCS) at theta (4 Hz) and gamma (75 Hz) frequencies on theta and high gamma electroencephalography (EEG) oscillatory power.  Methods:  In a single-blind, randomized, sham-controlled crossover design, 15 healthy participants were randomly assigned into 5 experimental sessions in which they received a-PCS/c-tPCS at 4 and 75 Hz or sham stimulation over the left primary motor cortex (M1) for 15 min at an intensity of 1.5 mA. Changes in theta and high gamma oscillatory power were recorded at baseline, immediately after, and 30 min after stimulation using EEG at rest with eyes open.  Results:  a-tPCS at 4 Hz showed a significant increase in theta power compared with sham, whereas c-tPCS at 4 Hz had no significant effect on theta power. a-tPCS at 75 Hz produced no changes in high gamma power compared with sham. Importantly, c-tPCS at 75 Hz led to a significant reduction in high gamma power compared with baseline, as well as compared with c-tPCS at 4 Hz and sham stimulation.  Conclusion:  The results demonstrate the modulation of oscillatory brain activity by monophasic tPCS, and highlight the need for future studies on a larger scale to confirm these initial findings. Impact statement Transcranial pulsed current stimulation (tPCS) is a novel brain stimulation technique. Recently, tPCS has been introduced to directly modulate brain oscillations by applying pulsatile current over the target brain area. Using both anodal and cathodal monophasic tPCS at theta and gamma frequencies, we demonstrate the ability of the stimulation to modulate brain activity. The present findings are the first direct electroencephalography evidence of an interaction between tPCS and ongoing oscillatory activity in the human motor cortex. Our work recommends tPCS as a tool for investigating human brain oscillations and open more studies in this area.",2020,"A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power.",['15 healthy participants'],"['Transcranial pulsed current stimulation (tPCS', 'PCS/c-tPCS at 4 and 75 Hz or sham stimulation over the left primary motor cortex (M1', 'transcranial pulsed current stimulation at 4 and 75 Hz on EEG theta and high gamma band power', 'monophasic anodal and cathodal-tPCS (a-tPCS/c-tPCS) at theta (4 Hz) and gamma (75 Hz) frequencies on theta and high gamma electroencephalography (EEG) oscillatory power']",['theta power'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}]",15.0,0.0508888,"A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power.","[{'ForeName': 'Thusharika', 'Initials': 'T', 'LastName': 'Dissanayaka', 'Affiliation': 'Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Aron T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'Monash Biomedical Imaging, Monash University, Melbourne, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Egan', 'Affiliation': 'Monash Biomedical Imaging, Monash University, Melbourne, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Brain connectivity,['10.1089/brain.2020.0756']
3263,32962950,Correction of the knee coronal plane deformity using the screws plus reconstruction plate versus cannulated screws.,"INTRODUCTION


Knee angular deformity is a common finding occurring in the childhood that can cause gait disturbances and early compartment osteoarthritis. Despite various surgical approaches presented to correct the angular deformities of the knee, there is still a search for the best approach. Thus, the present study was conducted to compare the results of using cannulated screw (CS) versus screw plus reconstruction plate (SpRP) for correction of angular deformities through a two-year follow-up study.
HYPOTHESIS


Percutaneous CS implantation is as efficacious as SpRP implantation for the correction of angular deformities of the knee.
MATERIAL AND METHODS


This randomised clinical trial (RCT) was conducted on 63 patients with angular deformities who were randomly divided into two groups including treatment with cannulated screw (CS) (n=32) and treatment with screw plus reconstruction plate (SpRP) (n=31). All the patients underwent the alignment view radiography of both lower limbs before surgical procedure and then within 3, 6, 12, 18 months and 2 years following the surgery. Afterwards, the patients' mechanical axis of the knees, medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), and varus/valgus angles were assessed and compared.
RESULTS


Results of the study showed that MPTA and LDFA significantly turned to the normal range during the 18 months follow-up in both treatment groups (p-value<0.001). Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001). Ultimate correction was achieved earlier in the CS treated group (12 months versus 18 months later).
DISCUSSION


Findings of the study revealed that the percutaneous CS implantation was successful similar to the SpRP implantation for correction of the angular deformity, while earlier ultimate angular correction and less pain complaint were among the superiorities of the CS.
LEVEL OF THE STUDY


II, comparative prospective study.",2020,Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001).,['63 patients with angular deformities'],"['screws plus reconstruction plate versus cannulated screws', 'cannulated screw (CS) versus screw plus reconstruction plate (SpRP', 'Percutaneous CS implantation', 'cannulated screw (CS', 'percutaneous CS implantation', 'screw plus reconstruction plate (SpRP']","['Varus and valgus angles', 'MPTA and LDFA', 'pain complaint', 'mechanical axis of the knees, medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), and varus/valgus angles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",63.0,0.0217714,Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Tahririan', 'Affiliation': 'Department of Orthopedics, Kashani Hospital, Isfahan, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Mohammadsharifi', 'Affiliation': 'Department of Orthopedics, Kashani Hospital, Isfahan, Iran. Electronic address: iman.m.sharifi@gmail.com.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.020']
3264,32963470,Interaction of Heavy Drinking Patterns and Depression Severity Predicts Efficacy of Quetiapine Fumarate XR in Lowering Alcohol Intake in Alcohol Use Disorder Patients.,"Background


Shared etiological pathways of dopamine and serotonin neurotransmission play a central role in heavy alcohol intake and exacerbation in the symptoms of depression.We investigated the treatment efficacy of Quetiapine fumarate extended release (XR) in lowering alcohol intake in alcohol use disorder (AUD) patients indicated by the shared alleviation of depression ratings and patterns of heavy drinking.
Methods


Hundred and eight male and female heavy drinking AUD patients in the age range of 18 to 64 years. participated in a randomized clinical trial (RCT) to receive 12 weeks of quetiapine XR or placebo (N = 115). Participants were sub-grouped by the severity grading of depression using Montgomery-Asberg Depression Rating Scale (MADRS) (clinically relevant ⩾8 [CR], clinically non-relevant ⩽7 [CNR]) at baseline in both the groups. Drinking history and depression ratings were assessed at the patients' visits.
Results


Heavy drinking days (HDD) and total drinks (TD) were significantly fewer in CR patients at the treatment end. A true positive response in AUROC analysis supported the lowering of TD in CR patients. The number of drinking days (NDD) and average drinks per drinking day (AvgD) were lower in the CNR patients at treatment-end. Significant associations with increasing effect sizes were observed for all the heavy drinking measures (HDD, TD, NDD, and AvgD) and MADRS scores by the end of the treatment course.
Conclusions


Baseline elevated depressive symptoms could likely predict the course of heavy alcohol drinking during the treatment, and efficacy outcome of a treatment. AUD patients with baseline clinically significant depression had a progressive lowering in heavy drinking markers significantly corresponding to the lowering of depression symptoms by the end of treatment with Quetiapine fumarate XR.ClinicalTrials.gov: NCT#0049862 (https://clinicaltrials.gov/ct2/show/NCT00498628?term=litten&draw=2&rank=3).",2020,Heavy drinking days (HDD) and total drinks (TD) were significantly fewer in CR patients at the treatment end.,"['Methods\n\n\nHundred and eight male and female heavy drinking AUD patients in the age range of 18 to 64 years', 'alcohol use disorder (AUD) patients', 'Alcohol Use Disorder Patients']","['Quetiapine fumarate extended release (XR', 'Quetiapine fumarate XR.ClinicalTrials.gov', 'quetiapine XR or placebo', 'Quetiapine Fumarate XR']","['Heavy drinking days (HDD) and total drinks (TD', 'Drinking history and depression ratings', 'depression symptoms', 'heavy drinking measures (HDD, TD, NDD, and AvgD) and MADRS scores', 'progressive lowering in heavy drinking markers', 'severity grading of depression using Montgomery-Asberg Depression Rating Scale (MADRS) (clinically relevant ⩾8 [CR], clinically non-relevant ⩽7 [CNR', 'number of drinking days (NDD) and average drinks per drinking day (AvgD']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0724680', 'cui_str': 'Quetiapine fumarate'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",8.0,0.0483862,Heavy drinking days (HDD) and total drinks (TD) were significantly fewer in CR patients at the treatment end.,"[{'ForeName': 'Vatsalya', 'Initials': 'V', 'LastName': 'Vatsalya', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Maiying', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Department of Biostatistics and Bioinformatics, University of Louisville, KY, USA.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Marsano', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Zimple', 'Initials': 'Z', 'LastName': 'Kurlawala', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Louisville, KY, USA.'}, {'ForeName': 'Kan V', 'Initials': 'KV', 'LastName': 'Chandras', 'Affiliation': 'Fort Valley State University, Warner Robbins, GA, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism NIH, Bethesda, MD, USA.'}, {'ForeName': 'Vijay A', 'Initials': 'VA', 'LastName': 'Ramchandani', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism NIH, Bethesda, MD, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, USA.'}]",Substance abuse : research and treatment,['10.1177/1178221820955185']
3265,32966105,Donor Cell Fate in Particulated Juvenile Allograft Cartilage for the Repair of Articular Cartilage Defects.,"BACKGROUND


Particulated juvenile allograft cartilage (PJAC) has demonstrated good clinical efficacy in repairing articular cartilage defects, but the related repair mechanism after transplant and the biological characteristics of the transplanted cells are still unclear.
PURPOSE


To study the efficacy of PJAC in repairing full-thickness cartilage defects and the specific fate of donor cells to provide experimental evidence for its clinical application.
STUDY DESIGN


Controlled laboratory study.
METHODS


Twenty female Guizhou minipigs were randomly divided into an experimental group and a control group. An 8-mm cylindrical full-thickness cartilage defect was created in the femoral trochlea of 1 knee in all minipigs. The experimental group received transplant of PJAC from 5 male juvenile Guizhou minipigs (PJAC group; n = 10) and the control group received autologous cartilage chips (ACC group; n = 10). Follow-up assessments were conducted at 1 month and 3 months to track the transplanted cells by the male-specific sex-determining region Y-linked (SRY) gene; tissue sections were hybridized in situ, and O'Driscoll histological scoring was performed according to hematoxylin and eosin staining, safranin O and fast green staining, and toluidine blue O staining, as well as immunohistochemical evaluation of aggrecan and Sry-type HMG-box 9 (SOX9).
RESULTS


All 20 Guizhou minipigs were followed; no infection or incision healing disorder occurred after the operation. By SRY in situ hybridization, the SRY signal of the transplanted cells was positive in the repaired tissue of the defect, and the SRY positive signal could still be detected in repaired tissue at 3 months postoperatively. The average number of positive cells was 68.6 ± 11.91 at 1 month and 32.6 ± 3.03 at 3 months (confocal microscope: ×400), and the difference was statistically significant. The O'Driscoll histological scores were 14 ± 0.71 in the ACC group and 9.8 ± 0.84 in the PJAC group at 1 month, and 18 ± 1.20 in the ACC group and 17.4 ± 1.14 in the PJAC group at 3 months. The scores were statistically significant between the ACC group and PJAC group at 1 month. The positive rates of SOX9 in the PJAC and ACC groups at 1 month were 67.6% ± 3.78% and 63.4% ± 5.30%, respectively, and the difference was not statistically significant ( P  > .05). The positive rates of SOX9 in the PJAC and ACC groups at 3 months were 68.8% ± 2.69% and 17.1% ± 1.26%, respectively, and the difference was statistically significant ( P  < .05). The positive rates of aggrecan in the PJAC and ACC groups at 1 month were 40.5% ± 2.78% and 42.4% ± 0.54% respectively, and the difference was not statistically significant ( P  > .05). The positive rates of aggrecan in the PJAC and ACC groups at 3 months were 40.8% ± 1.50% and 30.1% ± 2.44%, respectively, and the difference was not statistically significant ( P  > .05).
CONCLUSION


An animal model was established with Guizhou minipigs, and the cartilage defect was repaired with PJAC from male minipigs. The SRY gene positive signal could be detected from the repaired tissue by in situ hybridization, indicating that the transplanted cells survived at least 3 months. The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
CLINICAL RELEVANCE


This study suggests that it is feasible to study the biological characteristics of transplanted cells in the cartilage region by the sex-determining gene.",2020,"The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
","['Twenty female Guizhou minipigs', 'from 5 male juvenile Guizhou minipigs (PJAC group; n = 10) and the']","['PJAC', 'Particulated juvenile allograft cartilage (PJAC', 'control group received autologous cartilage chips (ACC', 'transplant of PJAC']","[""O'Driscoll histological scores"", 'infection or incision healing disorder', 'cartilage formation, SOX9 and aggrecan', 'positive rates of SOX9', 'positive rates of aggrecan', 'SOX9 expression', 'average number of positive cells']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0598067', 'cui_str': 'Cartilage formation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0081487', 'cui_str': 'Aggrecan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]",5.0,0.0335541,"The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
","[{'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Yunong', 'Initials': 'Y', 'LastName': 'Ao', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}]",The American journal of sports medicine,['10.1177/0363546520958700']
3266,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
3267,32971179,"High-intensity interval training on body composition, functional capacity and biochemical markers in healthy young versus older people.","BACKGROUND


The aim of the following study was to identify the effects of a 12-week high-intensity interval training (HIIT) program on the modification of parameters of body composition, functional capacity as well as lipid and glucose homeostasis markers in healthy young people versus older adults.
DESIGN


Experimental trial.
METHODS


Healthy young (YNG, 21 ± 1 years, BMI 26.01 ± 2.64 kg·m -2 , n = 10) and older (OLD, 66 ± 5 years, BMI 27.43 ± 3.11 kg·m -2 , n = 10) males were subjected to 12 weeks of HIIT. Prior to and immediately after the HIIT program, dual-energy X-ray absorptiometry, dominant leg strength one-repetition maximum (1-RM), maximal oxygen uptake (VO 2max ) and physical performance tests were performed. Blood samples were also taken.
RESULTS


Flexibility (P = 0.000), static balance (P = 0.004), timed up and go test (TUG) (P = 0.015), short physical performance battery (SPPB) (P = 0.005), dominant leg strength 1-RM (P = 0.012), and VO 2max  (P = 0.000) were better in YNG versus OLD. HIIT improved the % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), dominant leg strength 1-RM (P = 0.025), VO 2max  (P = 0.000), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006). TUG was improved by the training only in the OLD group (P = 0.016), but insulin (P = 0.002) and the homeostasis model assessment - insulin sensitivity (HOMA-IS) (P = 0.000) decreased only in the YNG group. HOMA-IS was correlated positive with BMI (R = 0.474, P = 0.035) and with whole-body fat mass (R = 0.517, P = 0.019).
CONCLUSIONS


HIIT for 12 weeks improves parameters of body composition, functional capacity and fasting serum lipid and glucose homeostasis markers in healthy young and older participants. Young people are shown as benefiting more.",2020,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","['Healthy young (YNG, 21\u202f±\u202f1\u202fyears, BMI 26.01\u202f±\u202f2.64, n\u202f=\u202f10) and older (OLD, 66\u202f±\u202f5\u202fyears, BMI 27.43\u202f±\u202f3.11, n\u202f=\u202f10) males', 'healthy young and older participants', 'healthy young versus older people', 'healthy young people vs older adults']","['high-intensity interval training (HIIT) program', 'High-intensity interval training']","['homeostasis model assessment - insulin sensitivity (HOMA-IS', 'HOMA-IS', 'repetition maximum (1-RM) dominant leg strength, maximal oxygen uptake (VO 2max ) and functional capacity tests', 'TUG', 'static balance', 'body composition, functional capacity and biochemical markers', 'body composition, functional capacity and fasting serum lipid and glucose homeostasis markers', 'Flexibility', 'leg lean mass', 'body composition, aerobic capacity, functional capacity as well as lipid and glucose homeostasis markers', 'timed up and go test (TUG', '1-RM dominant leg strength', 'physical performance', 'VO 2max', 'fasting cholesterol', 'fasting glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0125358,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","[{'ForeName': 'Gabriel Nasri', 'Initials': 'GN', 'LastName': 'Marzuca-Nassr', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile. Electronic address: gabriel.marzuca@ufrontera.cl.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Artigas-Arias', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'María Angélica', 'Initials': 'MA', 'LastName': 'Olea', 'Affiliation': 'Departamento de Educación Física, Deporte y Recreación, Facultad de Educación, Ciencias Sociales y Humanidades, Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'SanMartín-Calísto', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Nolberto', 'Initials': 'N', 'LastName': 'Huard', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Durán-Vejar', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Beltrán-Fuentes', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Muñoz-Fernández', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alegría-Molina', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sapunar', 'Affiliation': 'Departamento de Medicina Interna, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Salazar', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}]",Experimental gerontology,['10.1016/j.exger.2020.111096']
3268,32971190,Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program.,"RATIONALE & OBJECTIVE


Canagliflozin reduces the risk for cardiovascular and kidney outcomes in type 2 diabetes. This study aimed to assess the relative and absolute effects of canagliflozin on clinical outcomes across different KDIGO (Kidney Disease: Improving Global Outcomes) risk categories based on estimated glomerular filtration rate (eGFR) and urinary albumin-creatinine ratio.
STUDY DESIGN


Post hoc analysis of the CANagliflozin cardioVascular Assessment Study (CANVAS) Program.
SETTINGS & PARTICIPANTS


The CANVAS Program randomly assigned 10,142 participants with type 2 diabetes at high cardiovascular risk and with eGFR≥30mL/min/1.73m 2  to treatment with canagliflozin or placebo.
INTERVENTION(S)


Canagliflozin or matching placebo.
OUTCOMES


The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, with a set of other cardiovascular and kidney prespecified outcomes.
RESULTS


Of 10,142 participants, 10,031 (98.9%) had available baseline eGFR and urinary albumin-creatinine ratio data. The proportion of participants in low-, moderate-, high-, and very high-risk KDIGO categories was 58.6%, 25.8%, 10.6%, and 5.0%, respectively. The relative effect of canagliflozin on the primary outcome (HR, 0.86; 95% CI, 0.75-0.97) was consistent across KDIGO risk categories (P trend=0.2), with similar results for other cardiovascular and kidney outcomes. Absolute reductions in the primary outcome were greater within higher KDIGO risk categories (P trend=0.03) with a similar pattern of effect for the composite of cardiovascular death or hospitalization for heart failure (P trend=0.06) and for chronic eGFR slope (P trend = 0.04).
LIMITATIONS


Predominantly a low kidney risk population, relatively few participants in higher KDIGO risk categories, and exclusion of individuals with eGFR<30mL/min/1.73m 2 .
CONCLUSIONS


Although the relative effects of canagliflozin are similar across KDIGO risk categories, absolute risk reductions are likely greater for individuals at higher KDIGO risk. The KDIGO classification system may be able to identify individuals who might derive greater benefits for end-organ protection from treatment with canagliflozin.
FUNDING


This post hoc analysis was not specifically funded. The original CANVAS Program trials were funded by Janssen Research & Development, LLC and were conducted as a collaboration between the funder, an academic steering committee, and an academic research organization, George Clinical.
TRIAL REGISTRATION


The original trials of the CANVAS Program were registered at ClinicalTrials.gov with study numbers NCT01032629 and NCT01989754.",2020,"Absolute reductions in the primary outcome were greater within higher KDIGO risk categories (P-trend=0.03) with a similar pattern of effect for the composite of cardiovascular death or hospitalization for heart failure (P-trend=0.06) and for chronic eGFR slope (P-trend=0.04).
","['type 2 diabetes', 'Of 10,142 participants, 10,031 (98.9%) had available baseline eGFR and UACR data', ' Participants', '10,142 participants with type 2 diabetes at high cardiovascular risk and an eGFR of ≥30 mL/min/1.73 m 2  to']","['canagliflozin', 'canagliflozin or placebo', 'Canagliflozin', 'Canagliflozin or matching placebo']","['glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio', 'cardiovascular death or hospitalization for heart failure', 'risk of cardiovascular and kidney outcomes', 'higher KDIGO risk categories', 'chronic eGFR slope', 'composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death, with a set of other cardiovascular and kidney pre-specified outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",10142.0,0.354133,"Absolute reductions in the primary outcome were greater within higher KDIGO risk categories (P-trend=0.03) with a similar pattern of effect for the composite of cardiovascular death or hospitalization for heart failure (P-trend=0.06) and for chronic eGFR slope (P-trend=0.04).
","[{'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Blais', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Concord Repatriation General Hospital, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Janssen Scientific Affairs, LLC, Titusville, NJ.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Centre for Nephrology, University College London, London, United Kingdom. Electronic address: d.wheeler@ucl.ac.uk.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.06.018']
3269,32987346,The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome.,"BACKGROUND


Taping is frequently used as part of the multi-modal management for patellofemoral pain syndrome (PFPS). McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT) are proposed to be useful adjuncts to the management of PFPS. However, it is unclear if TIRLT offers similar benefits to PFJT, and its effect on pain and lower limb kinematics have not been investigated previously.
RESEARCH QUESTION


What are the effects of TIRLT, PFJT and no taping on perceived pain and lower limb kinematics during a lunge and single leg squat (SLS) in people with PFPS?
METHODS


This cross-sectional study compared the effects of TIRLT, PFJT and no taping, on knee pain and lower limb kinematics during two pain-provoking movements in people with PFPS. Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions: TIRLT, PFJT and no taping. The Codamotion system captured and analysed lower limb kinematic data in the sagittal, transverse and coronal planes. Peak knee pain intensity during the movement was assessed using the Numerical Rating Scale (NRS).
RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively). There was no evidence of altered lower limb kinematics accompanying pain reductions with either taping technique.
SIGNIFICANCE


Both forms of taping may be useful adjuncts as the short-term benefit of pain relief may enable participation in more active forms of rehabilitation.",2020,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","['people with PFPS', 'Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions', 'people with Patellofemoral pain syndrome', 'patellofemoral pain syndrome (PFPS']","['McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT', 'TIRLT, PFJT and no taping', 'McConnell patellofemoral joint and tibial internal rotation limitation taping techniques']","['Numerical Rating Scale (NRS', 'pain', 'Peak knee pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",23.0,0.053827,"RESULTS


Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Clifford', 'Affiliation': 'School of Allied Health and Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Amanda.clifford@ul.ie.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dillon', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hartigan', 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': ""O'Leary"", 'Affiliation': 'Physiotherapy Department, University Hospital Kerry, Kerry, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.010']
3270,32988822,A Population Pharmacokinetic Analysis of Continuous Infusion of Cloxacillin during  Staphylococcus aureus  Bone and Joint Infections.,"Intravenous administration of antibiotics is recommended during the early phase of methicillin-susceptible  S. aureus  (MSSA) bone and joint infection (BJI). We sought to compare the plasma concentrations of cloxacillin administered alternately by continuous and intermittent infusion (CI and ItI) in patients with MSSA BJI. In this prospective crossover trial, patients were randomly assigned to receive either 3 days of CI (two 75-mg/kg 12-h cloxacillin infusions per day) and then 3 days of ItI (four 37.5-mg/kg 1-h cloxacillin infusions per day) or vice versa. The drug concentration measurement was performed on day 3 of each type of administration at 1, 6, and 11 h and at 1, 2, 3, 4, and 6 h after the beginning of CI and ItI, respectively. We used the nonparametric algorithm NPAG to estimate population pharmacokinetic (PK) parameters. The final model was used to perform pharmacokinetic/pharmacodynamic (PK/PD) simulations and calculate the probabilities of target attainment (PTA) for several ItI and CI dosing regimens. We considered two PK/PD targets of time spent above the MIC for free cloxacillin concentrations ( fT   >MIC ): 50 and 100%. Eighty-four concentrations from 11 patients were analyzed. A two-compartment model adequately described the data. ItI with q6h regimens and short 1-h infusions of 2,000 or 3,000 mg were associated with low PTA, even for the low target (50%  fT   >MIC ) while 3-h infusions and continuous infusions (6 to 12 g/day) were associated with a PTA of >90% for an MIC up to 0.5 mg/liter. These results support the use of prolonged or continuous infusion of cloxacillin in patients with BJI.",2020,"ItI with q6h regimens and short 1h-infusion of 2000 or 3000 mg were associated with low PTA, even for the low target (50%  fT   > MIC ) while 3h-infusions and continuous infusions (6g to 12g per day) were associated with PTA > 90% for MIC up to 0.5","['patients with MSSA BJI', 'patients with BJI']","['cloxacillin', 'CI', 'antibiotics']",['plasma concentrations'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1635274', 'cui_str': 'Methicillin susceptible Staphylococcus aureus'}]","[{'cui': 'C0009077', 'cui_str': 'Cloxacillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",11.0,0.0404627,"ItI with q6h regimens and short 1h-infusion of 2000 or 3000 mg were associated with low PTA, even for the low target (50%  fT   > MIC ) while 3h-infusions and continuous infusions (6g to 12g per day) were associated with PTA > 90% for MIC up to 0.5","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Courjon', 'Affiliation': ""Université Côte d'Azur, CHU Nice, Infectiologie, Nice, France courjon.j@chu-nice.fr.""}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Garzaro', 'Affiliation': ""Université Côte d'Azur, CHU Nice, Infectiologie, Nice, France.""}, {'ForeName': 'Pierre-Marie', 'Initials': 'PM', 'LastName': 'Roger', 'Affiliation': 'Infectiologie, CHU de Pointe-à-Pitre, Pointe-à-Pitre, France.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Ruimy', 'Affiliation': ""Université Côte d'Azur, CHU, INSERM, C3M, Nice, France.""}, {'ForeName': 'Thibaud', 'Initials': 'T', 'LastName': 'Lavrut', 'Affiliation': 'Pharmacologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Mikaël', 'Initials': 'M', 'LastName': 'Chelli', 'Affiliation': 'Service de Chirurgie Orthopédique et Chirurgie du Sport, Institut Universitaire Locomoteur et du Sport, Hôpital Pasteur 2, CHU Nice, Nice, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Raynier', 'Affiliation': 'Service de Chirurgie Orthopédique et Chirurgie du Sport, Institut Universitaire Locomoteur et du Sport, Hôpital Pasteur 2, CHU Nice, Nice, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chirio', 'Affiliation': ""Université Côte d'Azur, CHU Nice, Infectiologie, Nice, France.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Demonchy', 'Affiliation': ""Université Côte d'Azur, CHU Nice, Infectiologie, Nice, France.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cabane', 'Affiliation': 'Rhumatologie, Hôpital Pasteur 2, CHU Nice, Nice, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jehl', 'Affiliation': 'Fédération de Médecine Translationnelle de Strasbourg, EA7290 Virulence Bactérienne Précoce, CHRU Strasbourg, Institut de Bactériologie, Université de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Trojani', 'Affiliation': ""Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Grillon', 'Affiliation': 'Fédération de Médecine Translationnelle de Strasbourg, EA7290 Virulence Bactérienne Précoce, CHRU Strasbourg, Institut de Bactériologie, Université de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Goutelle', 'Affiliation': 'Hospices Civils de Lyon, Groupement Hospitalier Nord, Service de Pharmacie, Lyon, France.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01562-20']
3271,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND


Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS


The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS


INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
3272,32992107,Disseminating trial results: We can have both faster and better.,,2020,,[],[],[],[],[],[],,0.0376918,,"[{'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. Electronic address: Gregory.E.Simon@kp.org.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Richesson', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]","Healthcare (Amsterdam, Netherlands)",['10.1016/j.hjdsi.2020.100474']
3273,32992136,Improving the performance of CNN to predict the likelihood of COVID-19 using chest X-ray images with preprocessing algorithms.,"OBJECTIVE


This study aims to develop and test a new computer-aided diagnosis (CAD) scheme of chest X-ray images to detect coronavirus (COVID-19) infected pneumonia.
METHOD


CAD scheme first applies two image preprocessing steps to remove the majority of diaphragm regions, process the original image using a histogram equalization algorithm, and a bilateral low-pass filter. Then, the original image and two filtered images are used to form a pseudo color image. This image is fed into three input channels of a transfer learning-based convolutional neural network (CNN) model to classify chest X-ray images into 3 classes of COVID-19 infected pneumonia, other community-acquired no-COVID-19 infected pneumonia, and normal (non-pneumonia) cases. To build and test the CNN model, a publicly available dataset involving 8474 chest X-ray images is used, which includes 415, 5179 and 2,880 cases in three classes, respectively. Dataset is randomly divided into 3 subsets namely, training, validation, and testing with respect to the same frequency of cases in each class to train and test the CNN model.
RESULTS


The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes. CAD also yields 98.4 % sensitivity (124/126) and 98.0 % specificity (2371/2418) in classifying cases with and without COVID-19 infection. However, without using two preprocessing steps, CAD yields a lower classification accuracy of 88.0 % (2239/2544).
CONCLUSION


This study demonstrates that adding two image preprocessing steps and generating a pseudo color image plays an important role in developing a deep learning CAD scheme of chest X-ray images to improve accuracy in detecting COVID-19 infected pneumonia.",2020,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.",[],[],[],[],[],[],,0.0223987,"The CNN-based CAD scheme yields an overall accuracy of 94.5 % (2404/2544) with a 95 % confidence interval of [0.93,0.96] in classifying 3 classes.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Heidari', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA. Electronic address: Morteza.heidari@ou.edu.'}, {'ForeName': 'Seyedehnafiseh', 'Initials': 'S', 'LastName': 'Mirniaharikandehei', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Abolfazl Zargari', 'Initials': 'AZ', 'LastName': 'Khuzani', 'Affiliation': 'Department of Electrical and Computer Engineering, University of California Santa Cruz, Santa Cruz, CA 95064, USA.'}, {'ForeName': 'Gopichandh', 'Initials': 'G', 'LastName': 'Danala', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'School of Electrical and Computer Engineering, University of Oklahoma, Norman, OK 73019, USA.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104284']
3274,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND


Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS


We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS


The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS


IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
3275,32916250,Impact of dedicated infectious disease teamwork on the treatment and prognosis of patients with diabetic foot infection.,"OBJECTIVE


The aim was to develop and evaluate the impact of a new model in which the infectious disease (ID) physician and pharmacist work together to treat diabetic foot infections (DFIs).
METHODS


A quasi-experimental before-after study was conducted. The medical charts of inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30). Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35).
RESULTS


The distribution of infection severity and levels of metabolic criteria were similar in the two groups. Compared with the control group, the intervention group received adequate initial empirical treatment more frequently (96.8% vs 43.5%, p < 0.001) and had a shorter median duration of fever (1 day vs 7.5 days, p < 0.001). Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
CONCLUSION


The early and full participation of ID physicians and pharmacists in the treatment of DFI facilitated targeted antimicrobial treatment and improved patient outcomes.",2020,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","['inpatients with DFI admitted between April 1, 2017 and March 31, 2018 were reviewed retrospectively (control group, n = 30', 'patients with diabetic foot infection', 'Inpatients diagnosed with DFI between April 1, 2018 and March 31, 2019 were enrolled prospectively as the intervention group and received treatment through dedicated ID teamwork (intervention group, n = 35']",['dedicated infectious disease teamwork'],"['Rates of healing and relapse', 'sites of osteomyelitis', 'distribution of infection severity and levels of metabolic criteria', 'polymicrobial infections', 'shorter median duration of fever']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0744130', 'cui_str': 'Diabetic foot infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0350705,"Rates of healing and relapse within 6 months were similar in the two groups, although the intervention group showed more sites of osteomyelitis (p = 0.036) and a higher percentage of polymicrobial infections (48.6% vs 10.0%, p = 0.001).
","[{'ForeName': 'Xiang-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Anti-infection, Institute of Clinical Pharmacology, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lixyan03598@pkufh.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: 04983@pkufh.com.'}, {'ForeName': 'Shuo-Han', 'Initials': 'SH', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: tianshuohan@126.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'He', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: doctorherui@163.com.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: jiangshan_beijing@163.com.'}, {'ForeName': 'Hui-Juan', 'Initials': 'HJ', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing 100034, China. Electronic address: lihuijuan2010@126.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.085']
3276,31373919,Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared with men.,"OBJECTIVE(S)


The short-term safety of treatment interruptions, a necessary part of cure studies, is not well established, particularly in women. We explored viral rebound kinetics and safety in a group of postpartum women discontinuing ART and compared results to men in historical interruption trials.
DESIGN


Prospective evaluation of time to virologic rebound.
METHODS


One thousand and seventy-six asymptomatic, virally suppressed, postpartum women living with HIV enrolled in the PROMISE trial with baseline CD4 cell counts at least 350 cells/μl underwent antiretroviral treatment (ART) discontinuation. Proportion with virologic suppression at weeks 4 and 12 were compared with participants in ACTG treatment interruption trials (91% male population).
RESULTS


In PROMISE, using interval censored methods, the estimated median time to HIV viral rebound was 2 weeks. An estimated 6% of women would remain virally suppressed at 30 weeks. Of those who had viral rebound by 30 weeks (N = 993), less than 4% experienced grade 3 or higher laboratory events, and 1% experienced WHO stage 2 or higher clinical events. Overall, less than 1% of participants progressed from WHO Stage 1 to Stage 2 or higher after discontinuation of ART, and 3.9% experienced a decline in CD4 cell count to less than 350 cells/μl or local treatment guidelines. A significantly higher proportion of women in PROMISE (25.4%) were virologically suppressed (<400 copies/ml) at 12 weeks compared with ACTG NWCS 371 participants (6.4%).
CONCLUSION


Temporary treatment interruptions in healthy, HIV-infected women with high CD4 cell counts can be well tolerated. Potential sex differences need to be considered in cure studies examining time to virologic rebound.",2019,"A significantly higher proportion of women in PROMISE (25.4%) were virologically suppressed (<400 copies/ml) at 12 weeks compared with ACTG NWCS 371 participants (6.4%).
","['healthy, HIV-infected women with high CD4 cell counts', 'postpartum women compared with men', 'One thousand and seventy-six asymptomatic, virally suppressed, postpartum women living with HIV enrolled in the PROMISE trial with baseline CD4 cell counts at least 350\u200acells/μl underwent antiretroviral treatment (ART) discontinuation']",['ACTG NWCS'],"['Time to viral rebound and safety', 'virologic suppression', 'median time to HIV viral rebound', 'CD4 cell count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C1318970', 'cui_str': 'AIDS Clinical Trial Group'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",1076.0,0.323882,"A significantly higher proportion of women in PROMISE (25.4%) were virologically suppressed (<400 copies/ml) at 12 weeks compared with ACTG NWCS 371 participants (6.4%).
","[{'ForeName': 'Catherine N', 'Initials': 'CN', 'LastName': 'Le', 'Affiliation': ""aUniversity of California Los Angeles, Los Angeles, California bHarvard T.H. Chan School of Public Health cBrigham and Women's Hospital, Boston, Massachusetts dSt. Jude Children's Research Hospital, Memphis, Tennessee eJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland fFHI 360, Durham, North Carolina gJohns Hopkins U. School of Medicine, Baltimore, Maryland hMassachusetts General Hospital and Ragon Institute, Harvard Medical School, Boston, Massachusetts iDAIDS, NIAID, Bethesda, Maryland, USA jAnova Health Institute, Johannesburg kSchool of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Britto', 'Affiliation': ''}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': ''}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': ''}, {'ForeName': 'Jonathan Z', 'Initials': 'JZ', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Flynn', 'Affiliation': ''}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': ''}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Bosch', 'Affiliation': ''}, {'ForeName': 'Rajesh T', 'Initials': 'RT', 'LastName': 'Gandhi', 'Affiliation': ''}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': ''}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002334']
3277,32965505,Personalized predictions of treatment outcome in patients with post-stroke depressive symptoms.,"OBJECTIVE


Post-stroke depressive symptoms have a vast individual and societal impact. However, research into interventions for such symptoms show contradictory results; it is unclear what works for which patients. In addition, clinical prediction tools are lacking. This study aimed to develop a prognostic index model for treatment outcome in patients with post-stroke depressive symptoms.
METHODS


Data from a randomized controlled trial (n = 61) evaluating 2 interventions for post-stroke depressive symptoms were used to predict post-treatment post-stroke depressive symptoms and participation. From 18 pre-treatment variables of patients and caregivers, predictors were selected using elastic net regression. Based on this selection, prognostic index scores (i.e. predictions) for both out-comes were computed for each individual patient.
RESULTS


The depression model included all pre-treatment variables, explaining 44% of the variance. The strongest predictors were: lesion location, employment, participation, comorbidities, mobility, sex, and pre-treatment depression. Six predictors of post-treatment participation were identified, explaining 51% of the variance: mobility, pre-treatment participation, age, satisfaction with participation, caregiver strain, and psychological distress of the spouse. The cross-validated prognostic index scores correlated highly with the actual outcome scores (depression: correlation = 0.672; participation: correlation = 0.718).
CONCLUSION


Post-stroke depressive symptoms form a complex and multifactorial problem. Treatment outcome is influenced by the characteristics of the stroke, the patients, and their spouses. The results show that psychological distress is probably no obstacle to attempting to improve participation. The personalized predictions (prognostic index scores) of treatment outcome show promising results, which, after further replication and validation, could aid clinicians with treatment selection.",2020,"The cross-validated prognostic index scores correlated highly with the actual outcome scores (depression: correlation = 0.672; participation: correlation = 0.718).
",['patients with post-stroke depressive symptoms'],[],"['lesion location, employment, participation, comorbidities, mobility, sex, and pre-treatment depression', 'characteristics of the stroke, the patient, and their spouse', 'satisfaction with participation, caregiver strain, and psychological distress of the spouse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",[],"[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0596369,"The cross-validated prognostic index scores correlated highly with the actual outcome scores (depression: correlation = 0.672; participation: correlation = 0.718).
","[{'ForeName': 'Johanne C C', 'Initials': 'JCC', 'LastName': 'Rauwenhoff', 'Affiliation': 'School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Bronswijk', 'Affiliation': ''}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bol', 'Affiliation': ''}, {'ForeName': 'Alexander C H', 'Initials': 'ACH', 'LastName': 'Geurts', 'Affiliation': ''}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'van Heugten', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2744']
3278,32961273,High-definition transcranial direct current stimulation facilitates emotional face processing in individuals with high autistic traits: A sham-controlled study.,"The deficit in emotional face processing is a critical impairment for individuals with high autistic traits. The temporalparietal junction(TPJ) is considered to be closely related to emotional face processing. The aim of this study was to examine the effect of highdefinition transcranial direct current stimulation (HD-tDCS) over the right temporal-parietal junction (rTPJ) on facial emotion processing of individuals with high autistic traits using eye-tracking technology. Twenty-nine participants with high autistic traits completed an eyetracking task (including happy, fearful and neutral faces) before and after five consecutive days of stimulation (anodal or sham). Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation. Moreover, this increased effect of mouth recognition with anodal rTPJ HD-tDCS was shown in both happy and fearful faces, but no remarkable difference was found in neutral faces. These findings suggest that right TPJ anodal HD-tDCS can facilitate emotional face processing in individuals with high autistic traits.",2020,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","['Twenty-nine participants with high autistic traits', 'individuals with high autistic traits', 'individuals with high autistic traits using eye-tracking technology', 'Individuals with High Autistic Traits']","['High-Definition Transcranial Direct Current Stimulation Facilitates Emotional Face Processing', 'TPJ anodal HD-tDCS', 'anodal HD-tDCS', 'highdefinition transcranial direct current stimulation (HD-tDCS', 'anodal rTPJ HD-tDCS', 'eyetracking task (including happy, fearful and neutral faces', 'right temporal-parietal junction (rTPJ']","['facial emotion processing', 'fixation time and fixation count', 'neutral faces']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",29.0,0.0460479,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","[{'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Xuan', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qianhui', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Gongjun', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Department of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: wangkai1964@126.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: zhanglei17236@aliyun.com.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135396']
3279,32961542,Memantine effects on auditory discrimination and training in schizophrenia patients.,"The uncompetitive low-affinity NMDA receptor antagonist, memantine, acutely increases electrophysiological measures of auditory information processing in both healthy subjects (HS) and patients with schizophrenia. Memantine effects on functional measures of auditory discrimination performance and learning are not known; conceivably, beneficial effects on these measures might suggest a role for memantine in augmenting the cognitive and functional impact of auditory targeted cognitive training (TCT). Here, carefully characterized HS (n = 20) and schizophrenia patients (n = 22) were tested in measures of auditory discrimination performance (words-in-noise (WIN), quick speech-in-noise (QuickSIN), gaps-in-noise) and auditory frequency modulation learning (a component of TCT) on 2 days about a week apart, after ingesting either placebo or 20 mg memantine po, in a double-blind, within-subject cross-over random order design. Memantine modestly enhanced functional measures of auditory discrimination in both schizophrenia patients (WIN) and HS (WIN and QuickSIN), as well as auditory frequency modulation learning in schizophrenia patients. These findings converge with a growing literature showing that memantine can enhance a range of metrics of auditory function. These properties could contribute to the apparent benefits of memantine as an adjunctive treatment in schizophrenia, and suggest that memantine might augment learning and potentially clinical gains from auditory-based TCT.",2020,"The uncompetitive low-affinity NMDA receptor antagonist, memantine, acutely increases electrophysiological measures of auditory information processing in both healthy subjects (HS) and patients with schizophrenia.","['healthy subjects (HS) and patients with schizophrenia', 'schizophrenia patients']","['placebo or 20\u2009mg memantine', 'Memantine', 'memantine', 'auditory discrimination performance (words-in-noise (WIN), quick speech-in-noise (QuickSIN), gaps-in-noise) and auditory frequency modulation learning (a component of TCT']","['functional measures of auditory discrimination', 'auditory discrimination and training']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0234747', 'cui_str': 'Sound discrimination'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0234747', 'cui_str': 'Sound discrimination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",22.0,0.0446759,"The uncompetitive low-affinity NMDA receptor antagonist, memantine, acutely increases electrophysiological measures of auditory information processing in both healthy subjects (HS) and patients with schizophrenia.","[{'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA. nswerdlow@health.ucsd.edu.'}, {'ForeName': 'Savita G', 'Initials': 'SG', 'LastName': 'Bhakta', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Talledo', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Kotz', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Royce Ellen', 'Initials': 'RE', 'LastName': 'Clifford', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Yash B', 'Initials': 'YB', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00865-8']
3280,32961681,The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy.,"The purpose of this study was to assess the influence of hippotherapy (therapy with horses) on posture and body function among children with cerebral palsy. A case-control study included forty-five children aged 6-12 years, classified as Gross Motor Function Classification System (GMFCS) level I or II, with spastic diplegia or hemiplegia. The participants were randomly divided into three groups: study I (n = 15), study II (n = 15) and control (n = 15). The children from the study groups attended 30min hippotherapy sessions for 12 consecutive weeks, twice (study group I) or once (study group II) a week. The Sitting Assessment Scale (SAS) was used. A comparison of SAS showed an improvement in almost all the assessed categories among the children who participated in hippotherapy. In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028). Hippotherapy has a positive influence on the body posture and function of individual body parts in a sitting position among children with cerebral palsy.",2020,"In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028).","['children who participated in hippotherapy', 'forty-five children aged 6-12 years, classified as Gross Motor Function Classification System ', 'children with cerebral palsy', 'Children with Cerebral Palsy']","['Hippotherapy', 'hippotherapy (therapy with horses', 'SAS']","['trunk control', 'Sitting Assessment Scale (SAS', 'posture and body function', 'head position control, arm function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",45.0,0.0101334,"In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028).","[{'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Matusiak-Wieczorek', 'Affiliation': 'Sports Medicine Institute, Social and Preventive Medicine Department, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Dziankowska-Zaborszczyk', 'Affiliation': 'Epidemiology and Biostatistics Institute, Social and Preventive Medicine Department, Medical University of Lodz, 90-752 Lodz, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Synder', 'Affiliation': 'Orthopedics Department, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Borowski', 'Affiliation': 'Orthopedics Department, Medical University of Lodz, 92-213 Lodz, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186846']
3281,32961878,Poor Sleep Quality Decreases Concurrent Training Benefits in Markers of Metabolic Syndrome and Quality of Life of Morbidly Obese Patients.,"Background:  Sleep quality (SQ) plays a role in multiple activities of daily living, but little is known about its role in concurrent training [CT, high-intensity interval (HIIT) plus resistance training (RT)] adaptations for metabolic syndrome (MetS) and health-related quality of life (HRQoL) markers. The aim of the present study was to determine the effects of a 20-week CT programme on MetS and HRQoL markers according to the SQ of morbidly obese patients.  Methods:  Twenty-nine morbidly obese patients were allocated to one of two groups: good sleep quality (GSQ, n = 15, 38.07 ± 12.26 years) and poor sleep quality (PSQ, n = 14, 40.79 ± 11.62 years). HRQoL, body mass index, waist circumference (WC), systolic and diastolic blood pressure (SDP and DBP, respectively), and plasma outcomes were measured.  Results:  The GSQ group reported significant changes (pre- vs. post-intervention) in WC (114.0 ± 3.1 vs. 110.4 ± 3.4 cm, p = 0.012), systolic blood pressure (SBP) (137.0 ± 4.3 vs. 125.6 ± 1.8 mmHg, p = 0.006), and HRQoL general health (51.33 ± 21.08 vs. 64.33 ± 16.24, p = 0.020). By contrast, the PSQ group showed significant changes only in SQ (9.00 ± 2.42 vs. 5.36 ± 2.84, p = 0.004).  Conclusions:  Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers. However, there was a greater effect size for decreasing WC and SBP in favour of the GSQ compared with the PSQ group, suggesting that there are limitations to CT benefits on these outcomes in the PSQ group. These results call for more complex future studies.",2020,Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers.,"['Morbidly obese PSQ patients', 'morbidly obese patients', 'Morbidly Obese Patients', 'Twenty-nine morbidly obese patients']","['PSQ', 'GSQ', '20-week CT programme']","['MetS and HRQoL markers', 'systolic blood pressure (SBP', 'good sleep quality', 'HRQoL general health', 'HRQoL, body mass index, waist circumference (WC), systolic and diastolic blood pressure (SDP and DBP, respectively), and plasma outcomes', 'poor sleep quality']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",29.0,0.0506513,Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Delgado-Floody', 'Affiliation': 'Department of Physical Education, Sport and Recreation, Universidad de La Frontera, Temuco 4780000, Chile.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'Department of Didactics of Corporal Expression, University of Jaen, 23400 Jaen, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerez-Mayorga', 'Affiliation': 'Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago 7591538, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Caamaño-Navarrete', 'Affiliation': 'Faculty of Education, Universidad Católica de Temuco, Temuco 4780000, Chile.'}, {'ForeName': 'Johnattan', 'Initials': 'J', 'LastName': 'Cano-Montoya', 'Affiliation': 'School of Kinesiology, Faculty of Health Sciences, Universidad San Sebastian, Valdivia 5090000, Chile.'}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'Laredo-Aguilera', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Carmona-Torres', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Cobo-Cuenca', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Pozuelo-Carrascosa', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Álvarez', 'Affiliation': 'Quality of Life and Wellness Research Group API4, Laboratory of Human Performance, Department of Physical Activity Sciences, Universidad de Los Lagos, Osorno 5290000, Chile.'}]",International journal of environmental research and public health,['10.3390/ijerph17186804']
3282,32962031,"Perspectives and Impact of a Parent-Child Intervention on Dietary Intake and Physical Activity Behaviours, Parental Motivation, and Parental Body Composition: A Randomized Controlled Trial.","Adults and children in Canada are not meeting physical activity guidelines nor consuming sufficient nutrient-rich foods. High engagement in these unhealthy behaviours can lead to obesity and its associated diseases. Parent-child interventions aimed at obesity prevention/treatment have assisted families with making positive changes to their nutrition and physical activity behaviours. Given that the home environment shapes early health behaviours, it is important to target both parents and children when addressing diet and physical activity. One method that has been shown to improve health outcomes is co-active coaching. The current study explored the impact of a three-month co-active coaching and/or health education intervention on the dietary intake and physical activity behaviours of parents with overweight/obesity and their children (ages 2.5-10; of any weight). Body composition (i.e., body mass index [BMI] and waist circumference), changes in parental motivation with respect to physical activity and dietary behaviours, and parental perceptions of program improvements were collected. A concurrent mixed methods study comprised of a randomized controlled trial and a descriptive qualitative design was utilized. Fifty parent-child dyads were recruited and randomly assigned to the control ( n  = 25) or intervention ( n  = 25) group. Assessments were completed at baseline, mid-intervention (six weeks), post-intervention (three months), and six-month follow-up. A linear mixed effects model was utilized for quantitative analysis. Inductive content analysis was used to extract themes from parent interviews. No significant results were observed over time for the dependent measures. Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families. Parents also shared barriers they faced when implementing changes (e.g., time, weather, stress). Qualitatively, both groups reported benefitting from this program, with the intervention group describing salient benefits from engaging in coaching. This research expands on the utility of coaching as a method for behaviour change, when compared to education only, in parents with overweight/obesity and their children.",2020,"Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families.","['parents with overweight/obesity and their children (ages 2.5-10; of any weight', 'Fifty parent-child dyads', 'parents with overweight/obesity and their children', 'Adults and children in Canada']","['Parent-Child Intervention', 'three-month co-active coaching and/or health education intervention']","['health outcomes', 'Body composition (i.e., body mass index', 'BMI] and waist circumference), changes in parental motivation with respect to physical activity and dietary behaviours, and parental perceptions of program improvements', 'Dietary Intake and Physical Activity Behaviours, Parental Motivation, and Parental Body Composition', 'dietary intake and physical activity behaviours']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.031059,"Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families.","[{'ForeName': 'Shazya', 'Initials': 'S', 'LastName': 'Karmali', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Battram', 'Affiliation': 'Food and Nutritional Sciences, Western University, Brescia University College, London, ON N6G 1H2, Canada.'}, {'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Burke', 'Affiliation': 'School of Health Studies, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Cramp', 'Affiliation': 'Middlesex London Health Unit, London, ON N6A 3N7, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Mantler', 'Affiliation': 'School of Health Studies, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morrow', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Ng', 'Affiliation': 'Department of Programs and Practice Support, College of Family Physicians of Canada, Mississauga, ON L4W 5A4, Canada.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Pearson', 'Affiliation': 'School of Kinesiology, Faculty of Health and Behavioural Sciences, Lakehead University, Thunder Bay, ON P7B 5E1, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Petrella', 'Affiliation': 'Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z3, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'School of Occupational Therapy, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Irwin', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17186822']
3283,32963103,Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study.,"OBJECTIVE


To determine whether intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions, would augment neural activity in patients with frontotemporal dementia (FTD) in brain regions associated with empathy, emotion processing, and the simulation network, as indexed by blood oxygen-level dependent (BOLD) signal during fMRI.
METHODS


In a placebo-controlled, randomized crossover design, 28 patients with FTD received 72 IU intranasal oxytocin or placebo and then completed an fMRI facial expression mimicry task.
RESULTS


Oxytocin alone and in combination with instructed mimicry increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
CONCLUSIONS


The findings demonstrate latent capacity to augment neural activity in affected limbic and other frontal and temporal regions during social cognition in patients with FTD, and support the promise and need for further investigation of these interventions as therapeutics in FTD.
CLINICALTRIALSGOV IDENTIFIER


NCT01937013.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that a single dose of 72 IU intranasal oxytocin augments BOLD signal in patients with FTD during viewing of emotional facial expressions.",2020,"RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","['patients with FTD', 'frontotemporal dementia', 'patients with FTD in brain regions associated with empathy, emotion processing and the simulation network, as indexed by blood-oxygen-level dependent (BOLD) signal during functional magnetic resonance imaging (fMRI', 'patients with FTD during viewing of emotional facial expressions', '28 patients with FTD received 72 IU of']","['intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions', 'oxytocin', 'placebo', 'Oxytocin', 'intranasal oxytocin or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0236642', 'cui_str': ""Pick's disease""}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],28.0,0.3629,"RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","[{'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Oliver', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kryklywy', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bartha', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Derek G V', 'Initials': 'DGV', 'LastName': 'Mitchell', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Finger', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada. Elizabeth.Finger@lhsc.on.ca.'}]",Neurology,['10.1212/WNL.0000000000010933']
3284,32969518,Accuracy of arrhythmia detection in implantable cardiac monitors: A prospective randomized clinical trial comparing Reveal LINQ and Confirm Rx.,"BACKGROUND


Implantable cardiac monitors (ICMs) are increasingly used to detect arrhythmias in various clinical situations. However, the data transmission time and accuracy of detecting cardiac arrhythmias are unclear.
OBJECTIVE


The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ with TruRhythm Detection with the Confirm Rx with SharpSense Technology.
METHODS


In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ or Confirm Rx ICM system. Arrhythmic events include atrial fibrillation (AF), pauses, and bradycardia. Data transmission time is defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy.
RESULTS


A total of 3510 events were transmitted in 61 patients over 7.1 ± 3.5 months. The transmission time both for all events (448 ± 271 vs 610 ± 515 minutes, P = .02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, P < .0001) was significantly shorter in the Confirm Rx group. The total number of events was also higher in the Confirm Rx group (25.5 ± 45.6 vs 0.9 ± 1.1 events per patient-month, P < .01), which is likely due to event transmission setting differences between the two groups. Kaplan-Meier analysis showed that the Confirm Rx group detected true arrhythmic episodes sooner with higher percentage of diagnosed patients during 6-month follow-up (P = .006). Patient-averaged true positive detection rates were not statistically significant in the two groups (Reveal LINQ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%).
CONCLUSION


Compared to the Reveal LINQ, Confirm Rx has shorter event transmission time, more frequent event detections, shorter duration to diagnose true arrhythmic events, and higher percentage of diagnosed patients. The accuracy of arrhythmia detection in both ICMs remains suboptimal.",2020,"Patient-averaged true positive detection rates were not statistically significant in the two groups (LINQ™ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%).
CONCLUSION


",['142 patients'],['Reveal LINQ TM  \xa0or Confirm Rx TM  ICM system'],"['bradycardia', 'true arrhythmic episodes', 'total number of events', 'Arrhythmic events include atrial fibrillation (AF), pauses and bradycardia', 'Patient-averaged true positive detection rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",142.0,0.0262682,"Patient-averaged true positive detection rates were not statistically significant in the two groups (LINQ™ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%).
CONCLUSION


","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ip', 'Affiliation': 'Sparrow Clinical Research Institute, Lansing, Michigan.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Jaffe', 'Affiliation': 'Munson Medical Center, Traverse City, Michigan.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Castellani', 'Affiliation': 'Sparrow Clinical Research Institute, Lansing, Michigan.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Sparrow Clinical Research Institute, Lansing, Michigan.'}, {'ForeName': 'Carson', 'Initials': 'C', 'LastName': 'Castellani', 'Affiliation': 'Michigan State University, East Lansing, Michigan.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Ip', 'Affiliation': 'Michigan State University, East Lansing, Michigan.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14076']
3285,32970172,Effects of β-Lactam Antibiotics on Gut Microbiota Colonization and Metabolites in Late Preterm Infants.,"We usually refer to the critical period for intestinal flora establishment as infancy because the infant gut microbiota is characterized by low diversity and poor stability compared with that of adults. Moreover, it is also vulnerable to interference from a variety of factors. As β-lactam antibiotics are typically used in newborn infants with infectious diseases, we used 16S rDNA sequencing and LC-MS metabolomics to analyze fecal microbes and metabolites in 16 late preterm infants with or without β-lactam antibiotic treatment. The subjects were assigned to two groups: one not treated with antibiotics and another receiving β-lactam antibiotic treatment for less than seven days. Significant changes in fecal microbes and metabolites were observed in the late preterm infants treated with antibiotics, including a reduction in the diversity of the gut microbiota overall and some beneficial bacteria such as Bacteroides, whereas some opportunistic pathogenic bacteria such as Enterococcus showed an overgrowth trend. In addition, significant changes in some crucial metabolites were observed, such as amino acids and bile acids. These findings show that treatment with β-lactam antibiotics might affect the intestinal flora and its metabolites in late preterm infants in a short time period.",2020,"Significant changes in fecal microbes and metabolites were observed in the late preterm infants treated with antibiotics, including a reduction in the diversity of the gut microbiota overall and some beneficial bacteria such as Bacteroides, whereas some opportunistic pathogenic bacteria such as Enterococcus showed an overgrowth trend.","['newborn infants with infectious diseases', '16 late preterm infants with or without β-lactam antibiotic treatment', 'Late Preterm Infants']","['β-lactam antibiotics', 'antibiotics and another receiving β-lactam antibiotic treatment', 'β-Lactam Antibiotics']","['intestinal flora and its metabolites', 'amino acids and bile acids', 'Gut Microbiota Colonization and Metabolites', 'fecal microbes and metabolites']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",16.0,0.0168328,"Significant changes in fecal microbes and metabolites were observed in the late preterm infants treated with antibiotics, including a reduction in the diversity of the gut microbiota overall and some beneficial bacteria such as Bacteroides, whereas some opportunistic pathogenic bacteria such as Enterococcus showed an overgrowth trend.","[{'ForeName': 'Siliang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Bingmei', 'Initials': 'B', 'LastName': 'Wei', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. chenyujun1006@163.com.'}]",Current microbiology,['10.1007/s00284-020-02198-7']
3286,32967151,"Effects of  Tetraselmis chuii  Microalgae Supplementation on Ergospirometric, Haematological and Biochemical Parameters in Amateur Soccer Players.","This study aimed to analyse the effects of  Tetraselmis chuii  (TC) microalgae supplementation during thirty days on ergospirometric, haematological and biochemical parameters in amateur soccer players. Thirty-two amateur soccer players divided into a control group (CG;  n  = 16; 22.36 ± 1.36 years; 68.36 ± 3.53 kg) and a supplemented group (SG;  n  = 16; 22.23 ± 2.19 years; 69.30 ± 5.56 kg) participated in the double-blind study. SG ingested 200 mg of the TC per day, while CG ingested 200 mg per day of lactose powder. Supplementation was carried out for thirty days. The participants performed a maximal treadmill test until exhaustion. The ergospirometric values at different ventilatory thresholds and haematological values were obtained after the test. Heart rate decreased after supplementation with TC ( p  < 0.05). Oxygen pulse, relative and absolute maximum oxygen consumption increased in SG (pre vs. post; 19.04 ± 2.53 vs. 22.08 ± 2.25; 53.56 ± 3.26 vs. 56.74 ± 3.43; 3.72 ± 0.35 vs. 3.99 ± 0.25;  p  < 0.05). Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05). On the other hand, haematocrit and mean platelet volume decreased in SG ( p  < 0.05). TC supplementation elicited improvements in ergospirometric and haematological values in amateur soccer players. TC supplementation could be valuable for improving performance in amateur athletes.",2020,Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05).,"['Amateur Soccer Players', 'amateur athletes', 'Thirty-two amateur soccer players divided into a control group (CG;  n  = 16; 22.36 ± 1.36 years; 68.36 ± 3.53 kg) and a supplemented group (SG;  n  = 16; 22.23 ± 2.19 years; 69.30 ± 5.56 kg) participated in the double-blind study', 'amateur soccer players']","['Tetraselmis chuii  (TC) microalgae supplementation', 'TC supplementation', 'Tetraselmis chuii  Microalgae Supplementation']","['Oxygen pulse, relative and absolute maximum oxygen consumption', 'haematocrit and mean platelet volume', 'Heart rate', 'Haemoglobin and mean corpuscular haemoglobin', 'Ergospirometric, Haematological and Biochemical Parameters', 'ergospirometric and haematological values']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708912', 'cui_str': '1.36'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517793', 'cui_str': '5.56'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C2936330', 'cui_str': 'Microphytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0200665', 'cui_str': 'Platelet mean volume determination'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0954851,Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05).,"[{'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Robles-Gil', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, School of Teacher Training, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodrigo', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186885']
3287,32971156,The effect of beta-glucan supplementation on glycemic control and variability in adolescents with type 1 diabetes mellitus.,"AIMS


This study aimed to investigate whether supplemental soluble fiber, oat β-glucan, has any effect on glycemic control and variability of adolescents with type 1 diabetes mellitus.
METHODS


This study was conducted in 30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week. At Phase I, all subjects followed a standard diet program. For Phase II and Phase III, the subjects continued their standard diet program and added natural oat flakes containing 3 g/day and 6 g/day β-glucan, respectively. Glucose levels were monitored by continuous glucose monitoring (CGM). The maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values in a target range and below and above a target values were calculated for each of the phases. Premeal, postmeal, peak blood glucose values and peak times of meals were evaluated for each of the phases. Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters.
RESULTS


The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p < 0.05). Minimal blood glucose levels were the highest at Phase III (p < 0.05). Phase I, II, and III showed similar durations elapsed for Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p > 0.05). Premeal and postmeal blood glucose levels were lowest at Phase III for breakfast, lunch, and overall (p < 0.05). The lowest peak blood glucose levels were detected at Phase III for breakfast, lunch, dinner and overall (p < 0.05). Phase III also showed delayed peaks for all time-points (p < 0.05 for each) compared to other phases. Phase III had significantly lower levels of SD, CV, LBGI, and CONGA levels than those in either Phase I or Phase II (p < 0.05 for each).
CONCLUSION


6 g/day oat β-glucan have favorable outcomes in glycemic control and variability in adolescents with type 1 diabetes mellitus.",2020,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","['Adolescents with Type 1 Diabetes Mellitus', '30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week', 'adolescents with type 1 diabetes mellitus']","['Beta-Glucan Supplementation', 'supplemental soluble fiber, oat β-glucan']","['lowest peak blood glucose levels', 'levels of SD, CV, LBGI, and CONGA levels', 'Premeal, postmeal, peak blood glucose values and peak times of meals', 'maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values', 'Glycemic Control and Variability', 'Glucose levels', 'maximal, mean and daytime and night blood glucose levels', 'Minimal blood glucose levels', 'Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters', 'glycemic control and variability', 'Premeal and postmeal blood glucose levels', 'Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p>0.05']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1134651', 'cui_str': 'Beta glucan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",30.0,0.00984219,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","[{'ForeName': 'Rukiye', 'Initials': 'R', 'LastName': 'Bozbulut', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey. Electronic address: dyt_rukiye@hotmail.com.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'Şanlıer', 'Affiliation': 'Ankara Medipol University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Döğer', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Bideci', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Çamurdan', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}, {'ForeName': 'Peyami', 'Initials': 'P', 'LastName': 'Cinaz', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, Turkey.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108464']
3288,32976938,A multicentre randomised phase III trial comparing pembrolizumab versus single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial.,"BACKGROUND


Malignant pleural mesothelioma (MPM) is an aggressive malignancy characterised by limited treatment options and a poor prognosis. At relapse after platinum-based chemotherapy, single-agent chemotherapy is commonly used and single-arm trials of immune-checkpoint inhibitors have demonstrated encouraging activity.
PATIENTS AND METHODS


PROMISE-meso is an open-label 1:1 randomised phase III trial investigating the efficacy of pembrolizumab (200 mg/Q3W) versus institutional choice single-agent chemotherapy (gemcitabine or vinorelbine) in relapsed MPM patients with progression after/on previous platinum-based chemotherapy. Patients were performance status 0-1 and unselected for programmed cell death ligand 1 (PD-L1) status. At progression, patients randomly assigned to receive chemotherapy were allowed to crossover to pembrolizumab. The primary end point was progression-free survival (PFS), assessed by blinded independent central review (BICR). Secondary end points were overall survival (OS), investigator-assessed PFS, objective response rate (ORR), and safety. Efficacy by PD-L1 status was investigated in exploratory analyses.
RESULTS


Between September 2017 and August 2018, 144 patients were randomly allocated (pembrolizumab: 73; chemotherapy: 71). At data cut-off [20 February 2019, median follow-up of 11.8 months (interquartile range: 9.9-14.5)], 118 BICR-PFS events were observed. No difference in BICR-PFS was detected [hazard ratio = 1.06, 95% confidence interval (CI): 0.73-1.53; P = 0.76], and median BICR-PFS (95% CI) for pembrolizumab was 2.5 (2.1-4.2), compared with 3.4 (2.2-4.3) months for chemotherapy. A difference in ORR for pembrolizumab was identified (22%, 95% CI: 13% to 33%), over chemotherapy (6%, 95% CI: 2% to 14%; P = 0.004). Forty-five patients (63%) assigned to chemotherapy received pembrolizumab at progression. With follow-up to 21 August 2019 [17.5 months: (14.8-19.7)], no difference in OS was detected between groups (HR = 1.12, 95% CI: 0.74-1.69; P = 0.59), even after adjusting for crossover. Pembrolizumab safety was consistent with previous observations. Exploratory efficacy analyses by PD-L1 status demonstrated no improvements in ORR/PFS/OS.
CONCLUSION


This is the first randomised trial evaluating the efficacy of pembrolizumab in MPM patients progressing after/on previous platinum-based chemotherapy. In biologically unselected patients, although associated with an improved ORR, pembrolizumab improves neither PFS nor OS over single-agent chemotherapy.",2020,"No difference in BICR-PFS was detected (HR=1.06, 95%CI:0.73-1.53; p=0.76), and median BICR-PFS (95% CI) for pembrolizumab was 2.5(2.1-4.2), compared with 3.4(2.2-4.3) months for chemotherapy.","['advanced pre-treated malignant pleural mesothelioma', 'relapsed MPM patients with progression after/on previous platinum-based chemotherapy', 'MPM patients progressing after/on previous platinum-based chemotherapy', 'Between September 2017 and August 2018', '144 patients were randomised']","['pembrolizumab (200mg/Q3W) vs institutional choice single-agent chemotherapy (gemcitabine or vinorelbine', 'pembrolizumab', 'pembrolizumab: 73; chemotherapy', 'platinum-based chemotherapy, single-agent chemotherapy', 'pembrolizumab vs single-agent chemotherapy']","['118 BICR-PFS events', 'median BICR-PFS', 'ORR/PFS/OS', 'progression-free survival (PFS), assessed by blinded independent central review (BICR', 'overall survival (OS), investigator assessed (IA)-PFS, objective response rate (ORR), and safety', 'ORR for pembrolizumab', 'OS', 'BICR-PFS', 'PFS nor OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0854891', 'cui_str': 'Pleural mesothelioma malignant recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",144.0,0.276011,"No difference in BICR-PFS was detected (HR=1.06, 95%CI:0.73-1.53; p=0.76), and median BICR-PFS (95% CI) for pembrolizumab was 2.5(2.1-4.2), compared with 3.4(2.2-4.3) months for chemotherapy.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Royal Marsden Hospital Fulham Road, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Curioni-Fontecedro', 'Affiliation': 'University Hospital Zürich, Department of Medical Oncology and Hematology, Zürich, Switzerland.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Kent Oncology Centre, Maidstone, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Royal Marsden Hospital Sutton, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pope', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fisher', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': ""King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'University Hospital Plymouth, Plymouth, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gautschi', 'Affiliation': 'University of Bern and Cantonal Hospital Luzern, Luzern Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland; Swiss Group for Clinical Cancer Research, Switzerland (SAKK), Bern.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Catalan Institute of Oncology (ICO), L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Janthur', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Switzerland (SAKK), Bern; Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'López Castro', 'Affiliation': 'Hospital Clínico Universitario de Valladolid, Valladolid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'García Campelo', 'Affiliation': 'Hospital Teresa Herrera, La Coruña, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rusakiewicz', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois CHUV, Centre of Experimental Therapies and Department of Oncology, Lausanne, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Letovanec', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois CHUV, Institute of Pathology, Lausanne, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Polydoropoulou', 'Affiliation': 'Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roschitzki-Voser', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ruepp', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gasca-Ruchti', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Department of Oncology, Lausanne, Switzerland.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Stahel', 'Affiliation': 'University Hospital Zürich, Department of Medical Oncology and Hematology, Zürich, Switzerland. Electronic address: Rolf.Stahel@etop-eu.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.09.009']
3289,32979620,"Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Although massive bleeding following transbronchial lung biopsies (TBLB) is rare, even minor hemorrhage may prolong the procedure and result in inadequate sampling. Tranexamic acid (TXA) is an antifibrinolytic agent, which reduces bleeding in numerous scenarios, however, its prophylactic use in mitigating post-TBLB bleeding has not been investigated. We conducted a prospective, randomized, double-blind, placebo-controlled trial to determine whether topical infusion of TXA prior to TBLB would reduce bleeding, shorten procedure duration and increase the number of biopsies obtained.
METHODS


We blindly randomized patients undergoing TBLB to receive topical TXA or placebo in the lobar bronchus prior to biopsies. Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained were measured. Data was analyzed using the two-tailed Student's T-Test, Chi-square or Mann-Whitney tests as appropriate.
RESULTS


Fifty patients were randomized, 26 to the TXA arm. The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90). There were no clinically significant adverse events in any of the groups up to one month of follow up.
CONCLUSION


Endobronchial installation of TXA prior to obtaining TBLB results in less bleeding and allows more biopsies to be obtained with no additional adverse events. The prophylactic use of TXA during TBLB may be considered as standard.",2020,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","['We blindly randomized patients undergoing TBLB to receive', 'Fifty patients were randomized, 26 to the TXA arm']","['Tranexamic acid (TXA', 'topical TXA or placebo', 'tranexamic acid', 'placebo', 'TXA']","['number of biopsies obtained', 'adverse events', 'procedure length', ""Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained"", 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.616386,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","[{'ForeName': 'Rottem', 'Initials': 'R', 'LastName': 'Kuint', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. Electronic address: kuint@hadassah.org.il.'}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Institute of Pulmonary Medicine, Chaim Sheba Medical Center, The Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Cohen Goichman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Huszti', 'Affiliation': 'Biostatistics Research Unit, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abu Rmeileh', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Shriki', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Abutbul', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Zvi G', 'Initials': 'ZG', 'LastName': 'Fridlender', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Berkman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106162']
3290,32979635,Endothelial shear stress and vascular remodeling in bioresorbable scaffold and metallic stent.,"BACKGROUND AND AIMS


The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up.
METHODS


In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks.
RESULTS


Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Post-procedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling.
CONCLUSIONS


In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.",2020,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.",[],"['bioresorbable scaffold (BRS', 'endothelial shear stress (ESS']",['Endothelial shear stress and vascular remodeling'],[],"[{'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3850148', 'cui_str': 'Vascular Remodeling'}]",,0.0802054,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.","[{'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Tenekecioglu', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Bellvitge University Ho^spital, Barcelona, Spain.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Hopital de Rangueil, Toulouse, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Rinse', 'Initials': 'R', 'LastName': 'Johannes van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'S Maria University Hospital, Terni, Italy.'}, {'ForeName': 'Ad J van', 'Initials': 'AJV', 'LastName': 'Boven', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': 'Biomédiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Bristol Heart Institute, Bristol, United Kingdom.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Kitslaar', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jouke', 'Initials': 'J', 'LastName': 'Dijkstra', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johan H C', 'Initials': 'JHC', 'LastName': 'Reiber', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Ural', 'Affiliation': 'Department of Cardiology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Pekkan', 'Affiliation': 'Department of Mechanical Engineering, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Christos V', 'Initials': 'CV', 'LastName': 'Bourantas', 'Affiliation': 'Department of Cardiology, University College of London Hospitals, London, United Kingdom; Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gijsen', 'Affiliation': 'Department of Biomedical Engineering, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Torii', 'Affiliation': 'Department of Mechanical Engineering, University College London, United Kingdom.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, London, United Kingdom; Department of cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.031']
3291,33002684,Positive memory training for the treatment of depression in schizophrenia: A randomised controlled trial.,"BACKGROUND


Around half of people diagnosed with schizophrenia suffer from co-morbid depression, yet there are no evidence-based psychological treatments to target this presentation.
METHOD


Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression. Participants were randomly assigned (1:1) to receive PoMeT or treatment as usual. PoMeT was delivered in up to 12 individual sessions within 3 months. We stratified randomisation by site and by severity of depression using randomised-permuted blocks. Assessments were carried out at baseline, 3-month, 6-month and 9-month by assessors who were blind to treatment allocation. The primary outcome was reduction in the symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II. Analysis was by intention-to-treat with linear mixed-effects models. The trial was registered with the ISRCTN registry number 99485756.
RESULTS


One hundred participants were randomly assigned to either PoMeT (n = 49) or treatment as usual (n = 51). The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
DISCUSSION


To our knowledge this is, to date, the largest powered randomised controlled trial focused on the psychological treatment of depression in people diagnosed with schizophrenia. Results indicate that a brief targeted intervention can reduce the symptoms of depression in the group. The main limitation of the study is the lack of an active control group which may contribute to an inflated treatment effect.",2020,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","['people diagnosed with schizophrenia', 'One hundred participants', 'Participants were aged 18-65 years old, had a clinical diagnosis of schizophrenia or schizoaffective disorder and at least a mild level of depression', 'depression in schizophrenia']","['PoMeT', 'Positive memory training']","['symptoms of depression', 'symptoms of depression at 3-month, 6-month and 9-month as measured by the BDI-II', 'reduction in BDI-II total score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0561841', 'cui_str': 'Pleasant memories'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.285473,"The reduction in BDI-II total score at 3 months was significantly greater for PoMeT than for treatment as usual (mean difference = 4.33, SE = 2.00, 95% CI 0.38 to 8.23; p = 0.03).
","[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Steel', 'Affiliation': 'Oxford Health NHS Foundation Trust, Oxford, UK; School of Psychology, University of Reading, UK. Electronic address: craig.steel@hmc.ox.ac.uk.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Anxiety Disorders, PsyQ Parnassia Group, Psychiatric Center, The Hague, the Netherlands; Department of Medical and Clinical Psychiatry, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fazil Baksh', 'Affiliation': 'Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AL, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kingdon', 'Affiliation': 'University of Southampton, Highfield, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Health Economics, Center for Public Health, Medical University of Vienna, 1090, Wien, Kinderspitalgasse 15, Austria; Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford OX3 7JX, UK.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': 'Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Phiri', 'Affiliation': 'Southern Health NHS Foundation Trust, Research & Development Department, Tom Rudd Unit, Moorgreen Hospital, Botley Rd, West End Southampton, SO30 3JB, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'VU University and Amsterdam Public Mental Health Research Institute, Department of Clinical Psychology Van der Boechorststraat 1, 1081, BT, Amsterdam, the Netherlands; Parnassia Psychiatric Institute, Zoutkeetsingel 40, 2512, HN, The Hague, the Netherlands.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103734']
3292,33002685,Collaborative care for depression in older adults: How much is enough?,"Collaborative care in primary care has been shown to be effective for subthreshold depression in older adults in the 'CASPER' trial. However, to understand the impact of adherence, and to explore the minimum effective dose of collaborative care, we reanalysed the trial data using a complier average causal effect (CACE) analysis. Data were available for 705 participants, 519 with 12-month PHQ-9 scores. 'Compliance' could be observed for participants in the intervention group. Latent complier status in the control group was estimated. Completion of five or more sessions of care was defined as 'compliance'. Sensitivity analyses, using alternative cut-offs of two to eight sessions, assessed the impact of changing the definition of 'compliance'. Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported. Sensitivity analyses confirmed statistically significant differences between the intervention and control groups in those attending five or more sessions. We conclude that collaborative care is causally effective in reducing subthreshold depressive symptoms in older people who adhere to treatment. Our findings suggest the minimum effective dose is five sessions.",2020,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","['older adults', '705 participants, 519 with 12-month PHQ-9 scores. ', 'older people who adhere to treatment']","['collaborative care', 'Collaborative care']","['lower PHQ-9 scores', 'subthreshold depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",705.0,0.060507,"Compliers in the intervention group had lower PHQ-9 scores at 12-month follow up than assumed compliers in the control group (1.75 lower, 95% confidence interval 0.29 to 3.21, p = 0.02), a greater effect than originally reported.","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Bonvoisin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull University Teaching Hospitals NHS Trust, Hull, HU3 2JZ, UK. Electronic address: ttb508@york.ac.uk.'}, {'ForeName': 'Lewis W', 'Initials': 'LW', 'LastName': 'Paton', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: lewis.paton@york.ac.uk.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK. Electronic address: catherine.hewitt@york.ac.uk.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McMillan', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: dean.mcmillan@york.ac.uk.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: simon.gilbody@york.ac.uk.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tiffin', 'Affiliation': 'Department of Health Sciences, University of York, Heslington, YO10 5DD, UK; Hull York Medical School, University of York, Heslington, YO10 5DD, UK. Electronic address: paul.tiffin@york.ac.uk.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103725']
3293,32963047,"A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.","OBJECTIVES


Recent advances in systemic sclerosis (SSc) show that it involves a T-helper type-2-oriented immune response with interleukin (IL)-4 and IL-13. Romilkimab is an engineered, humanised, bispecific immunoglobulin-G4 antibody that binds and neutralises IL-4/IL-13 making it ideal for exploration in fibrosis.
METHODS


Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy, were randomised (1:1) to subcutaneous romilkimab 200 mg or placebo one time per week for 24 weeks in this double-blind, proof-of-concept, phase II study. The primary endpoint was change in modified Rodnan skin score (mRSS) from baseline to week 24.
RESULTS


Ninety-seven patients were randomised to romilkimab (n=48) or placebo (n=49) for 24 weeks. Least-squares mean (SE) change in mRSS was -4.76 (0.86) for romilkimab versus -2.45 (0.85) for placebo yielding a mean (SE) (90% CI) difference of -2.31 (1.21) (-4.32 to -0.31; p=0.0291, one-sided). Treatment-emergent AEs were balanced between placebo (n=41; 84%) and romilkimab (n=40; 80%). Most were mild-to-moderate and discontinuations were low (three overall). There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related. Two patients in the placebo group had a cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy), but there were no cardiac safety signals with romilkimab.
CONCLUSION


This study demonstrated significant effects on skin changes with romilkimab in early dcSSc that require confirmation with a longer and more comprehensive phase III study to determine clinical relevance.
TRIAL REGISTRATION NUMBER


NCT02921971.",2020,"There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related.","['early diffuse cutaneous systemic sclerosis', 'Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy', 'Ninety-seven patients']","['romilkimab (SAR156597', 'placebo', 'subcutaneous romilkimab 200\u2009mg or placebo', 'romilkimab']","['cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy', 'deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo', 'modified Rodnan skin score (mRSS', 'Least-squares mean (SE) change in mRSS']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439073', 'cui_str': '97'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1262147', 'cui_str': 'Scleroderma renal crisis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",97.0,0.626656,"There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related.","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Paris Descartes University, Paris, France yannick.allanore@cch.aphp.fr.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wung', 'Affiliation': 'Sanofi R&D, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Soubrane', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Esperet', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Marrache', 'Affiliation': 'Immunology and Inflammation, Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Bejuit', 'Affiliation': 'Statistics and Programming, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Lahmar', 'Affiliation': 'Global Safety, Sanofi R&D, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Rheumatology Clinic, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Centre for Rheumatology and and Connective Tissue Diseases, University College London Division of Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218447']
3294,32969562,Mindfulness training preserves sustained attention and resting state anticorrelation between default-mode network and dorsolateral prefrontal cortex: A randomized controlled trial.,"Mindfulness training can enhance cognitive control, but the neural mechanisms underlying such enhancement in children are unknown. Here, we conducted a randomized controlled trial (RCT) with sixth graders (mean age 11.76 years) to examine the impact of 8 weeks of school-based mindfulness training, relative to coding training as an active control, on sustained attention and associated resting-state functional brain connectivity. At baseline, better performance on a sustained-attention task correlated with greater anticorrelation between the default mode network (DMN) and right dorsolateral prefrontal cortex (DLPFC), a key node of the central executive network. Following the interventions, children in the mindfulness group preserved their sustained-attention performance (i.e., fewer lapses of attention) and preserved DMN-DLPFC anticorrelation compared to children in the active control group, who exhibited declines in both sustained attention and DMN-DLPFC anticorrelation. Further, change in sustained-attention performance correlated with change in DMN-DLPFC anticorrelation only within the mindfulness group. These findings provide the first causal link between mindfulness training and both sustained attention and associated neural plasticity. Administered as a part of sixth graders' school schedule, this RCT supports the beneficial effects of school-based mindfulness training on cognitive control.",2020,"At baseline, better performance on a sustained-attention task correlated with greater anticorrelation between the default mode network (DMN) and right dorsolateral prefrontal cortex (DLPFC), a key node of the central executive network.",['sixth graders (mean age 11.76\u2009years'],"['Mindfulness training', 'school-based mindfulness training', 'school-based mindfulness training, relative to coding training as an active control']","['sustained attention and resting state anticorrelation', 'sustained-attention performance', 'lapses of attention) and preserved DMN-DLPFC anticorrelation']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",,0.028885,"At baseline, better performance on a sustained-attention task correlated with greater anticorrelation between the default mode network (DMN) and right dorsolateral prefrontal cortex (DLPFC), a key node of the central executive network.","[{'ForeName': 'Clemens C C', 'Initials': 'CCC', 'LastName': 'Bauer', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Rozenkrantz', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Nieto-Castanon', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, Massachusetts, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'West', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mrazek', 'Affiliation': 'Department of Psychological and Brain Sciences, University of California, Santa Barbara, California, USA.'}, {'ForeName': 'Dawa T', 'Initials': 'DT', 'LastName': 'Phillips', 'Affiliation': 'Empowerment Holdings, Santa Barbara, California, USA.'}, {'ForeName': 'John D E', 'Initials': 'JDE', 'LastName': 'Gabrieli', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Whitfield-Gabrieli', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}]",Human brain mapping,['10.1002/hbm.25197']
3295,32966877,Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.,"BACKGROUND


The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers.
METHOD


To investigate the ""real-world"" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
RESULTS


The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables.
CONCLUSIONS


This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.",2020,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","['US smokers', 'California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1', '359 participants (average age 39\u202fyears; average cigarette consumption half a pack/day']","['Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack', 'Real-world exposure to graphic warning labels', 'repackaging cigarettes from standard US packs to GWL plain packs']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],359.0,0.0172592,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: jppierce@ucsd.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: dstrong@ucsd.edu.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Stone', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: m3stone@ucsd.edu.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: adriana.villasenor@sdcounty.ca.gov.'}, {'ForeName': 'Claudiu V', 'Initials': 'CV', 'LastName': 'Dimofte', 'Affiliation': 'Department of Marketing, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, United States. Electronic address: cdimofte@sdsu.edu.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Leas', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ecleas@ucsd.edu.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Oratowski', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: joratowski@ucsd.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brighton', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ebrighton@ucsd.edu.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hurst', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States. Electronic address: shurst@ucsd.edu.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Pulvers', 'Affiliation': 'Department of Psychology, Social and Behavioral Sciences Building, California State University, San Marcos 200 E Barham Dr, San Marcos, CA, 92096, United States. Electronic address: kpulvers@csusm.edu.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kealey', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States.'}, {'ForeName': 'Ruifeng', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ruc075@ucsd.edu.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Messer', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: kmesser@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106152']
3296,32967619,Advance care planning with people with dementia: a process evaluation of an educational intervention for general practitioners.,"BACKGROUND


General practitioners (GPs) are advised to offer advance care planning (ACP) to people with dementia (PWD). In a randomized controlled trial, an educational intervention for GPs aimed at initiating and optimizing ACP proved to be effective. During the intervention most GPs were accompanied by their practice nurse (PN). To provide insights into the intervention's successful components and what could be improved, we conducted a process evaluation and explored implementation, mechanisms of impact and contextual factors.
METHODS


We used the Medical Research Council guidance for process evaluations. Implementation was explored identifying reach and acceptability. We performed descriptive analyses of participants' characteristics; selection, inclusion and intervention attendance; a GP post-intervention survey on initiating ACP; a post intervention focus group with trainers of the intervention. Mechanisms of impact were explored identifying adoption and appropriateness. We used: participants' intervention ratings; a GP post-intervention survey on conducting ACP; ACP documentation in PWD's medical files; post-intervention interviews with PWD/FC dyads. All data was used to identify contextual factors.
RESULTS


The intervention was implemented by a small percentage of the total Dutch GP population invited, who mostly included motivated PWD/FC dyads with relatively little burden, and PWD with limited cognitive decline. The mechanisms of impact for GPs were: interactively learning to initiate ACP with training actors with a heterogeneous group of GPs and PNs. For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL. Some dyads however found ACP stressful and not feasible. Younger female GPs more often initiated ACP. Male PWD and those with mild dementia more often had had ACP. These characteristics and the safe and intimate training setting, were important contextual facilitators.
CONCLUSION


We recommend Interventions aimed at improving ACP initiation with PWD by GPs to include interactive components and discussion of non-medical preferences. A safe environment and a heterogeneous group of participants facilitates such interventions. However, in practice not all FC/PWD dyads will be ready to start. Therefore, it is necessary to check their willingness when ACP is offered.",2020,"For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL.","['people with dementia', 'general practitioners', 'Male PWD and those with mild dementia more often had had ACP', 'total Dutch GP population invited, who mostly included motivated PWD/FC dyads with relatively little burden, and PWD with limited cognitive decline', 'people with dementia (PWD']","['educational intervention', 'GP post-intervention survey on initiating ACP', 'Advance care planning', ""GP post-intervention survey on conducting ACP; ACP documentation in PWD's medical files; post-intervention interviews with PWD/FC dyads""]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",[],,0.0454545,"For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL.","[{'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Tilburgs', 'Affiliation': 'Department of IQ Healthcare, Radboudumc, Nijmegen, The Netherlands. Bram.Tilburgs@radboudumc.nl.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Koopmans', 'Affiliation': 'Department of primary and community care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schers', 'Affiliation': 'Department of primary and community care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Smits', 'Affiliation': 'Research Group Innovating with Older Adults, Windesheim University of Applied Sciences, Zwolle, The Netherlands.'}, {'ForeName': 'Myrra', 'Initials': 'M', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'Department of IQ Healthcare, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': 'Department of primary and community care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of anesthesiology, pain and palliative medicine, Radboudumc, Nijmegen, The Netherlands.'}]",BMC family practice,['10.1186/s12875-020-01265-z']
3297,32971277,Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.,"BACKGROUND


Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.
METHODS


Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.
RESULTS


Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m 2 .
CONCLUSIONS


Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.",2020,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","['mean age of 58 and is 23% female and 72% African American', 'Patients with Clinic-Refractory Diabetes Mellitus', 'January 2020; 200 patients', 'patients with clinic-refractory diabetes mellitus (PRACTICE-DM']","['comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management', 'standard VHA Home Telehealth (HT) telemonitoring/care coordination']","['diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs', 'Mean baseline HbA1c and BMI']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",200.0,0.0844592,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Tarkington', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Strawbridge', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States of America; VA Mid-Atlantic Mental Illness, Research, Education and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Shivan', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Garrett', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Wilmot', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Marcano', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Overby', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Glenda A', 'Initials': 'GA', 'LastName': 'Tisdale', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Durkee', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bullard', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Moahad S', 'Initials': 'MS', 'LastName': 'Dar', 'Affiliation': 'Greenville VA Health Care Center, Greenville, NC, United States of America; Division of Endocrinology, Department of Medicine, Brody School of Medicine at East Carolina University, Greenville, NC, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Mundy', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Hiner', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Sonja K', 'Initials': 'SK', 'LastName': 'Fredrickson', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Nadya T', 'Initials': 'NT', 'LastName': 'Majette Elliott', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Howard', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Jeter', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Danus', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of Endocrinology, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America. Electronic address: matthew.crowley@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106157']
3298,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND


Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS


Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS


On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS


Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS


Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
3299,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND


Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS


In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS


Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS


Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
3300,33007031,Oral intake of mesoporous silica is safe and well tolerated in male humans.,"BACKGROUND


Precisely engineered mesoporous silica has been shown to induce weight loss in mice, but whether it is safe to use in humans have not investigated.
OBJECTIVE


The aim was to determine whether oral dosing, up to 9 grams/day, of precisely engineered mesoporous silica as a food additive can be used safely in male humans.
DESIGN


This single blinded safety study consisted of two study arms including 10 males each (18-35 years). One arm consisted of participants with normal weight and one with obesity. After a placebo run-in period, all subjects were given porous silica three times daily, with increasing dose up to 9 grams/day (Phase 1). Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2).
RESULTS


All participants completed Phase 1 and 90% completed Phase 2, with approximately 1% missed doses. Participants reported no abdominal discomfort, and changes in bowel habits were minor and inconsistent. The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
CONCLUSION


Mesoporous silica intake of up to 9 grams/day can be consumed by males without any major adverse events or safety concerns.",2020,"The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
","['male humans', 'Subjects with obesity continued the study with highest dose for additional 10 weeks (Phase 2', '10 males each (18-35 years', 'participants with normal weight and one with obesity']",['placebo'],"['weight loss', 'Mesoporous silica intake', 'abdominal discomfort, and changes in bowel habits']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort'}, {'cui': 'C0278008', 'cui_str': 'Altered bowel function'}]",,0.0774239,"The side effects observed were mild and tolerable, biomarkers did not give any safety concern, and no severe adverse events occurred.
","[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Elimam', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kupferschmidt', 'Affiliation': 'Department of Molecular Biosciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Ekbom', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rössner', 'Affiliation': 'Apple Bay Obesity Research Centre, Bromma, Sweden.'}, {'ForeName': 'Muhammad Naeem', 'Initials': 'MN', 'LastName': 'Iqbal', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lindgren', 'Affiliation': 'Sigrid Therapeutics AB, Stockholm, Sweden.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'Department of Molecular Biosciences, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240030']
3301,33010371,Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months.,"AIM


The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months.
METHODS


Paramedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods.
RESULTS


767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings.
CONCLUSION


There were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.",2020,"No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16).","['Paramedics from four ambulance services in England', 'Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent', 'Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA', '767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months']","['gel supraglottic airway device (SGA) with tracheal intubation (TI', 'i-gel Supraglottic Airway Device Versus Tracheal Intubation', 'i-gel SGA']","['hospital discharge', 'modified Rankin Scale (mRS) score', 'primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery', 'EQ-5D-5L scores']","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.103585,"No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16).","[{'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Benger', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, UK. Electronic address: Jonathan.Benger@uwe.ac.uk.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Lazaroo', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Clout', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Voss', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Black', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Brett', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Kirby', 'Affiliation': 'University of the West of England, Glenside Campus, Bristol, UK; South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK; Department of Anaesthesia, Royal United Hospital, Bath, UK.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Scott', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK; National Institute for Health Research Applied Research Collaboration West (NIHR ARC West), University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Smartt', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'South', 'Affiliation': 'South Western Ambulance Service NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Intensive Care Unit, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.'}]",Resuscitation,['10.1016/j.resuscitation.2020.09.026']
3302,33015912,Comparable quality of bowel preparation with single-day versus three-day low-residue diet: Randomized controlled trial.,"BACKGROUND AND AIMS


There is controversy about the length of low-residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one-day vs. three-day LRD associated to standard laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy.
METHODS


A non-inferiority, randomized, controlled, parallel-group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomized to receive 1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥ 2 in all colon segments. Analysis was performed for a non-inferiority margin of 5%, a 95% statistical power and one-sided 0.05 significance level.
RESULTS


A total of 855 patients were randomized. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1-day LRD group vs 96.9% in the 3-day LRD group achieved the primary outcome (P-value for non-inferiority < 0.001). The percentage of patients with BBPS scores ≥ 8 was superior in the 1-day LRD group (254 vs 221 in the 3-day LRD group, P = 0.032). The 1-day regimen was better tolerated than the 3-day diet. 47.7% (vs 28.7%, P < 0.05) of patients rated the 1-day LRD as very easy to follow.
CONCLUSION


The 1-day LRD is non-inferior to 3-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.",2020,One-day LRD is non-inferior to three-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.,"['average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy', '855 patients were randomised']","['single-day versus three-day low-residue diet', '1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment', 'standard laxative treatment']","['BBPS ≥2 in all colon segments', 'Adequate bowel preparation', 'Boston Bowel Preparation Scale (BBPS', 'percentage of patients with BBPS scores']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}]","[{'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",855.0,0.18648,One-day LRD is non-inferior to three-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.,"[{'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Machlab', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Martínez-Bauer', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'López', 'Affiliation': ""Clinical Epidemiology and Cancer Screening, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Piqué', 'Affiliation': 'Microbiology Section, Department of Biology, Healthcare and Environment, Faculty of Pharmacy and Food Sciences, Universitat de Barcelona (UB), Barcelona, Spain.'}, {'ForeName': 'Valentí', 'Initials': 'V', 'LastName': 'Puig-Diví', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Junquera', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Lira', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Brullet', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Selva', 'Affiliation': ""Clinical Epidemiology and Cancer Screening, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García-Iglesias', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Calvet', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Campo', 'Affiliation': ""Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.""}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13860']
3303,32971964,Gaelic4Girls-The Effectiveness of a 10-Week Multicomponent Community Sports-Based Physical Activity Intervention for 8 to 12-Year-Old Girls.,"Girls are less active than boys throughout childhood and adolescence, with limited research focusing on female community sports-based programs. This study aims to assess the effectiveness of a multi-component, community sports-based intervention for increasing girl's physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing, as relative to a second treatment group (the traditionally delivered national comparative program), and a third control group. One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban) were allocated to one of three conditions: (1) Intervention Group 1 (n = 43) received a novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention; (2) Intervention Group 2 (n = 44) used the traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention (group 1 or 2) conditions and were expected to carry out their usual LGF community sports activities. Primary outcome measurements (at both pre- and 10-week follow up) examining the effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support). Following a two (pre to post) by three (intervention group 1, intervention group 2, and control group 3) mixed-model ANOVA, it was highlighted that intervention group 1 significantly increased in PA ( p  = 0.003), FMS proficiency ( p  = 0.005) and several psychological correlates of PA ( p  ≤ 0.005). The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.",2020,"The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.","['One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban', '8 to 12-Year-Old Girls']","['10-Week Multicomponent Community Sports-Based Physical Activity Intervention', 'traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention', 'novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention', 'multi-component, community sports-based intervention']","['effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support', ""girl's physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing"", 'several psychological correlates of PA', 'FMS proficiency']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0574307', 'cui_str': 'Scottish Gaelic language'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0574307', 'cui_str': 'Scottish Gaelic language'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.0183106,"The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.","[{'ForeName': 'Orlagh', 'Initials': 'O', 'LastName': 'Farmer', 'Affiliation': 'Sports Studies and Physical Education Program, School of Education, 2 Lucan Place, Western Road, 0000 Cork, Ireland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cahill', 'Affiliation': 'School of Education, Postgraduate Diploma in Special Educational Needs, University College Cork, 0000 Cork, Ireland.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': ""O'Brien"", 'Affiliation': 'Sports Studies and Physical Education Program, School of Education, 2 Lucan Place, Western Road, 0000 Cork, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186928']
3304,32972007,Effectiveness of  SaBang - DolGi  Walking Exercise Program on Physical and Mental Health of Menopausal Women.,"OBJECTIVE


We investigated the effectiveness of a 12-week SaBang-DolGi walking exercise program on the physical and mental health of menopausal women and aimed to provide the basic data needed to develop health promotion programs for the active and healthy aging of menopausal women.
MATERIALS AND METHODS


The participants comprised 40 women aged 50-65 years who were divided into two randomly selected groups in training sessions (exercising group, n = 21 and control group, n = 19). A physical (grip, muscle and endurance) test and mental health test (simple mental health test II) were conducted using questionnaires with the aim of examining subjects' physical and mental health before and after exercise.
RESULTS


After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains. Controlled and regular exercise for 12 weeks was significantly correlated with a positive change in vitality and mental health.
CONCLUSIONS


We found that the SaBang-DolGi walking exercise program helps to promote the physical and mental health of menopausal women who are exposed to the various stresses and depressions that accompany physical deterioration; the program was found to encourage active and healthy aging.",2020,"After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains.","['Menopausal Women', 'participants comprised 40 women aged 50-65 years', 'menopausal women']","['A physical (grip, muscle and endurance) test and mental health test (simple mental health test II', 'training sessions (exercising group', 'SaBang - DolGi  Walking Exercise Program', 'SaBang-DolGi walking exercise program']","['positive change in vitality and mental health', 'mental well-being and menopause-related health and subdomains', 'Physical and Mental Health']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",40.0,0.0282647,"After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains.","[{'ForeName': 'EunHee', 'Initials': 'E', 'LastName': 'Noh', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'JiYoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'MunHee', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Korea National Sport University, Seoul 05541, Korea.'}, {'ForeName': 'EunSurk', 'Initials': 'E', 'LastName': 'Yi', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186935']
3305,32976205,Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial.,"BACKGROUND


Dexmedetomidine is being used increasingly as a premedicant in the paediatric population. However, the effectiveness of pre-operative intranasal dexmedetomidine premedication, compared with oral midazolam, for emergence delirium is not well characterised.
OBJECTIVE


To identify the effectiveness of pre-operative intranasal dexmedetomidine for emergence delirium in the paediatric patient population following general anaesthesia.
DESIGN


A prospective, randomised, double-blind, parallel-group, placebo-controlled trial.
SETTING


Single university teaching hospital, from September 2013 to August 2014.
PATIENTS


One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study.
INTERVENTION


Patients were randomised in a 1 : 1 : 1 ratio to receive premedication with intranasal dexmedetomidine 2 μg kg (the dexmedetomidine group), oral midazolam 0.5 mg kg (the midazolam group), or 0.9% saline (the placebo group).
MAIN OUTCOME MEASURES


The primary outcome was the incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale. Secondary outcomes included the quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction.
RESULTS


The incidence of emergence delirium was lower in patients given dexmedetomidine compared with that in patients given midazolam (11.5 versus 44%, relative risk = 0.262, 95% confidence interval 0.116 to 0.592) or 0.9% saline (11.5 versus 49%, relative risk = 0.235, 95% confidence interval 0.105 to 0.525). Likewise, the incidence of PONV was lower in the dexmedetomidine group (3.8%) than that in the midazolam (22%; P = 0.006) or placebo (29.4%; P < 0.001) groups. However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
CONCLUSION


In paediatric patients undergoing strabismus surgery intranasal dexmedetomidine 2 μg kg premedication decreases the incidence of emergence delirium and PONV, and improves parents' satisfaction compared with oral midazolam.
TRIAL REGISTRATION


ClinicalTrials.gov (identifier: NCT01895023).",2020,"However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
","['paediatric patients undergoing strabismus surgery intranasal', 'Single university teaching hospital, from September 2013 to August 2014', 'paediatric patient population following general anaesthesia', 'children undergoing strabismus surgery', 'One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study']","['pre-operative intranasal dexmedetomidine', 'midazolam premedication', 'Dexmedetomidine', 'placebo', 'dexmedetomidine', 'intranasal dexmedetomidine 2\u200aμg\u200akg (the dexmedetomidine group), oral midazolam 0.5\u200amg\u200akg (the midazolam group), or 0.9% saline (the placebo', 'midazolam', 'Intranasal dexmedetomidine']","[""quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction"", 'incidence of emergence delirium', 'postoperative pain scores and length of postanaesthesia care unit stay', ""incidence of emergence delirium and PONV, and improves parents' satisfaction"", 'incidence of PONV', 'incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",156.0,0.767456,"However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001270']
3306,32979640,"Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease.","BACKGROUND


The negative impact of COPD on patients is not only physical, but also social and psychological.
OBJECTIVES


To examine the effects of decreased exercise capacity on health outcomes in patients with COPD.
METHODS


516 COPD patients divided into four groups according to the six-minute walking distances. Perception of dyspnea, quality of life, psychological symptoms were compared between groups.
RESULTS


All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001). Anxiety, depression and dyspnea scores were found to be lower (p<0.001) in all those walking over 350 m (p<0,001).
CONCLUSIONS


It has been observed that markers such as quality of life, anxiety and depression, which are known to be affected in COPD patients, progress better especially in patients walking over 350 m.",2020,"All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001).","['patients with chronic obstructive pulmonary disease', 'patients with COPD', '516 COPD patients divided into four groups according to the six-minute walking distances']",['exercise capacity'],"['Perception of dyspnea, quality of life, psychological symptoms', 'health outcomes', 'Anxiety, depression and dyspnea scores', 'disease-specific quality of life scores', 'perception of dyspnea, psychological symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",516.0,0.0268225,"All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001).","[{'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hulya', 'Affiliation': 'Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital, Chest Diseases Clinic, Izmir, Turkey. Electronic address: drhdogan@yahoo.com.'}, {'ForeName': 'Naz', 'Initials': 'N', 'LastName': 'Ilknur', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Polat', 'Initials': 'P', 'LastName': 'Gulru', 'Affiliation': 'Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital, Chest Diseases Clinic, Izmir, Turkey.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.09.008']
3307,32979642,Incidence of immediate postextubation complications in critically Ill adult patients.,"BACKGROUND


Postextubation complication rates vary among studies. It is necessary to standardize a method to identify postextubation complications and determine their potential association with extubation failure and reintubation in critically ill adult patients.
OBJECTIVES


To describe immediate (up to 60 min) endotracheal postextubation complications in critically ill adult patients and determine whether these complications are associated with extubation failure.
METHODS


Secondary analysis of a Randomized Clinical Trial that included 240 critically ill adult patients, who were eligible for extubation. Overall complications include at least one major complication (upper airway obstruction, desaturation, vomiting, post-obstructive pulmonary edema) and/or minor complications (bronchospasm, severe cough, hypertension, tachycardia, tachypnea, poor respiratory mechanics).
RESULTS


Incidence of overall, major and minor complications was 71.2%, 30.9% and 62.7%, respectively. Forty (16.9%) patients failed extubation, and thirty (12.7%) were reintubated. Of 168 patients who developed a postextubation complication, 137 (81.5%) were successfully extubated. Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
CONCLUSION


We have observed high incidence rates of overall, major and minor complications. The development of major complications was statistically significantly associated with extubation failure and reintubation. It is still unknown whether the identification and treatment of immediate postextubation complications have positive effects on patients' clinical course or whether the complications are a mere effect of the extubation procedure.",2020,"Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
","['critically ill adult patients', '240 critically ill adult patients, who were eligible for extubation', '168 patients who developed a postextubation complication, 137 (81.5%) were successfully extubated', 'critically Ill adult patients']",[],"['major complication (upper airway obstruction, desaturation, vomiting, post-obstructive pulmonary edema) and/or minor complications (bronchospasm, severe cough, hypertension, tachycardia, tachypnea, poor respiratory mechanics', 'Incidence of overall, major and minor complications', 'Overall complications']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4517569', 'cui_str': '137'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",240.0,0.149797,"Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
","[{'ForeName': 'Mauro Federico', 'Initials': 'MF', 'LastName': 'Andreu', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina; Universidad Nacional de la Matanza, San Justo, Province of Buenos Aires, Argentina. Electronic address: mfandreu@gmail.com.'}, {'ForeName': 'Marco Guillermo', 'Initials': 'MG', 'LastName': 'Bezzi', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina.'}, {'ForeName': 'María Eugenia', 'Initials': 'ME', 'LastName': 'Dotta', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.09.016']
3308,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS


In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS


Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION


Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
3309,32986940,Efficacy of Extracorporeal Shockwave Therapy on Cervical Myofascial Pain Following Neck Dissection Surgery: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the efficacy of extracorporeal shockwave therapy (ESWT) on cervical myofascial pain following neck dissection in reducing pain and improving cervical range of motion (ROM).
METHODS


Forty-six patients with cervical myofascial pain following neck dissection surgery were recruited and subdivided at random into two equal groups. The ESWT group received ESWT once a week for 4 weeks (0.25 mL/mm2, 1,000 shocks) and a topical non-steroidal anti-inflammatory drug (3 times/day for 4 weeks). The control group received only topical NSAID. The pain assessment was done by using the visual analog scale (VAS) and pressure algometry. A cervical ROM device was used for the assessment of the lateral flexion and rotation of the neck ROM on both sides. All measurements were collected at baseline, 2 weeks, and 4 weeks.
RESULTS


The ESWT group revealed a significant improvement in all parameters at post I and post II than did the control group (p>0.001), that revealed a statistical decrease only in the VAS score at post I without any statistical difference in the pain threshold and neck ROM. However, there were statistical differences in all parameters at post II compared to those at pre-treatment and post I (p<0.001).
CONCLUSION


As a confirmation of the efficacy of ESWT in cervical myofascial pain control following neck dissection, we observed better results with no side effects in the ESWT group (Clinical Trial Registry No. PACTR202002648274347).",2020,"The ESWT group revealed a significant improvement in all parameters at post I and post II than did the control group (p>0.001), that revealed a statistical decrease only in the VAS score at post I without any statistical difference in the pain threshold and neck ROM.","['cervical myofascial pain control following neck dissection', 'Methods\n\n\nForty-six patients with cervical myofascial pain following neck dissection surgery']","['Extracorporeal Shockwave Therapy', 'topical non-steroidal anti-inflammatory drug', 'extracorporeal shockwave therapy (ESWT', 'Neck Dissection Surgery', 'topical NSAID', 'ESWT']","['pain assessment', 'cervical myofascial pain', 'VAS score', 'visual analog scale (VAS) and pressure algometry', 'pain threshold and neck ROM', 'Cervical Myofascial Pain', 'pain and improving cervical range of motion (ROM']","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1319209', 'cui_str': 'Neck joint - range of movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",46.0,0.0674619,"The ESWT group revealed a significant improvement in all parameters at post I and post II than did the control group (p>0.001), that revealed a statistical decrease only in the VAS score at post I without any statistical difference in the pain threshold and neck ROM.","[{'ForeName': 'FatmaAlzahraa Hassan', 'Initials': 'FH', 'LastName': 'Kamel', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Saudi Arabia.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Basha', 'Affiliation': 'Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Buraidah, Saudi Arabia.'}, {'ForeName': 'Ashwag', 'Initials': 'A', 'LastName': 'Alsharidah', 'Affiliation': 'Department of Physiology, College of Medicine, Qassim University, Buraidah, Saudi Arabia.'}, {'ForeName': 'Islam Mohamed', 'Initials': 'IM', 'LastName': 'Hewidy', 'Affiliation': 'Department of Physical Therapy, New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ezzat', 'Affiliation': 'Department of Physical Therapy for Orthopedics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nancy Hassan', 'Initials': 'NH', 'LastName': 'Aboelnour', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}]",Annals of rehabilitation medicine,['10.5535/arm.20055']
3310,32986941,"Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema.","OBJECTIVE


To evaluate the effects of extracorporeal shockwave therapy (ESWT) on improving lymphedema, quality of life, and fibrous tissue in patients with stage 2 lymphedema.
METHODS


Breast cancer-related lymphedema patients referred to the rehabilitation center were recruited. We enrolled stage 2 lymphedema patients who had firmness of the skin at their forearm, a circumference difference of more than 2 cm between each arm, or a volume difference between upper extremities greater than 200 mL, confirmed by lymphoscintigraphy. The patients were randomly divided into the ESWT group and the control group. ESWT was performed for 3 weeks (two sessions per week); both groups received complex decongestive physical therapy. All patients were evaluated at baseline and at 3 weeks after treatment. The measurements performed included visual analog scale score, volume, circumference, QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) score, bioelectrical impedance, and skin thickness.
RESULTS


The patients in both groups (n=15 in each group) completed the 3-week therapy experiment. No significant differences were observed in demographic characteristics between groups. After the 3-week treatment period, improvement was noted in the circumference difference below the elbow, volume, ratio of extracellular water to total body water, and skin thickness in the ESWT group. A significant difference was found in all the above-mentioned areas except in circumference below the elbow in the ESWT group.
CONCLUSION


ESWT reduced edema and skin fibrosis without significant complications. Therefore, ESWT can be used together with complex decongestive physical therapy for treating lymphedema.",2020,"A significant difference was found in all the above-mentioned areas except in circumference below the elbow in the ESWT group.
","['enrolled stage 2 lymphedema patients who had firmness of the skin at their forearm, a circumference difference of more than 2 cm between each arm, or a volume difference between upper extremities greater than 200 mL, confirmed by lymphoscintigraphy', 'patients with stage 2 lymphedema', 'Methods\n\n\nBreast cancer-related lymphedema patients referred to the rehabilitation center were recruited']","['Extracorporeal Shockwave Therapy', 'complex decongestive physical therapy', 'ESWT', 'extracorporeal shockwave therapy (ESWT']","['edema and skin fibrosis', 'lymphedema, quality of life, and fibrous tissue', 'circumference difference below the elbow, volume, ratio of extracellular water to total body water, and skin thickness', 'Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema', 'visual analog scale score, volume, circumference, QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) score, bioelectrical impedance, and skin thickness', 'demographic characteristics']","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0412375', 'cui_str': 'Radioisotope scan of lymphatic system'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0263008', 'cui_str': 'Fibrosis of the skin'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0225331', 'cui_str': 'Fibrous tissue'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0194452,"A significant difference was found in all the above-mentioned areas except in circumference below the elbow in the ESWT group.
","[{'ForeName': 'Kyeong Woo', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sang Beom', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jong Hwa', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Young Sam', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Dong-A University College of Medicine, Busan, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.19213']
3311,32988827,Outcomes in Participants with Renal Impairment from a Phase 3 Clinical Trial for Ceftolozane/Tazobactam Treatment of Nosocomial Pneumonia (ASPECT-NP).,"In the phase 3 ASPECT-NP trial (NCT02070757), ceftolozane/tazobactam (C/T) was noninferior to meropenem for treatment of Gram-negative ventilated hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (vHABP/VABP). Here, we report outcomes in participants from ASPECT-NP with renal impairment (RI). Participants were categorized by their baseline renal function as follows: normal renal function (NRF; creatinine clearance [CL CR ], ≥80 ml/min), mild RI (CL CR , >50 to <80 ml/min), moderate RI (CL CR , ≥30 to ≤50 ml/min), and severe RI (CL CR , ≥15 to <30 ml/min). Dosing of both study drugs was adjusted based on renal function. The following C/T doses were administered every 8 h: NRF or mild RI, 3 g; moderate RI, 1.5 g; and severe RI, 0.75 g. The primary and key secondary endpoints were day 28 all-cause mortality (ACM) and clinical response at the test-of-cure visit in the intention-to-treat (ITT) population, respectively. In the ITT population, day 28 ACM rates for the C/T arm versus the meropenem arm were 17.6% versus 19.1% (NRF), 36.6% versus 28.6% (mild RI), 31.4% versus 38.5% (moderate RI), and 35.3% versus 61.9% (severe RI). Rates of clinical cure in the ITT population for the C/T arm versus the meropenem arm were 58.1% versus 58.5% (NRF), 54.9% versus 45.5% (mild RI), 37.1% versus 42.3% (moderate RI), and 41.2% versus 47.6% (severe RI). Small sample sizes in the RI groups resulted in large 95% confidence intervals (CIs), limiting conclusive interpretation of the analysis. Both drugs were well tolerated across all renal function groups. Overall, these results support the use of the study dosing regimens of C/T for treatment of vHABP/VABP in patients with RI. (This study has been registered at ClinicalTrials.gov under identifier NCT02070757.).",2020,"In the intention-to-treat population (ITT), day 28 ACM rates for the C/T arm versus the meropenem arm were 17.6% versus 19.1% (NRF), 36.6% versus 28.6% (mild RI), 31.4% versus 38.5% (moderate RI), and 35.3% versus 61.9% (severe RI), respectively.","['patients with RI', 'Treatment of Nosocomial Pneumonia (ASPECT-NP', '50 to <80 mL/min); moderate RI (CL CR  ≥30 to ≤50 mL/min); and severe RI (CL CR  ≥15 to <30 mL/min', 'Participants with Renal Impairment from a Phase 3 Clinical Trial for', 'participants from ASPECT-NP with renal impairment (RI']","['meropenem', 'Ceftolozane/Tazobactam', 'ceftolozane/tazobactam (C/T']","['Rates of clinical cure', 'day 28 all-cause mortality (ACM) and clinical response at the test-of-cure visit', 'baseline renal function: normal renal function (NRF; creatinine clearance [CL CR ] ≥80 mL/min); mild RI (CL CR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C3656593', 'cui_str': 'Ceftolozane and tazobactam'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",,0.109839,"In the intention-to-treat population (ITT), day 28 ACM rates for the C/T arm versus the meropenem arm were 17.6% versus 19.1% (NRF), 36.6% versus 28.6% (mild RI), 31.4% versus 38.5% (moderate RI), and 35.3% versus 61.9% (severe RI), respectively.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Huntington', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA Brian.Yu@merck.com.'}, {'ForeName': 'Linping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Jensen', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bruno', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Boakye', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Zufei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hwa-Ping', 'Initials': 'HP', 'LastName': 'Feng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rhee', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00731-20']
3312,32986758,Radiofrequency ablation using internally cooled wet electrodes in bipolar mode for the treatment of recurrent hepatocellular carcinoma after locoregional treatment: A randomized prospective comparative study.,"OBJECTIVE


This study aimed to compare the efficacy between bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes, in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
MATERIALS AND METHODS


In this single-center, two-arm, parallel-group, randomized controlled study, we performed a 1:1 random allocation on eligible patients with recurrent HCC after locoregional treatment, to receive TICW-RFA or SC-RFA. The primary endpoint was the minimum diameter of the ablation zone per unit ablation time. Secondary endpoints included other technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes.
RESULTS


Enrolled patients were randomly assigned to the TICW-RFA group (n = 40) or SC-RFA group (n = 37). The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577). Total RF energy delivery (11.75 ± 9.04 kcal vs. 22.61 ± 12.98 kcal, p < 0.001) and energy delivery per unit time (0.81 ± 0.49 kcal/min vs. 1.45 ± 0.42 kcal/min, p < 0.001) of the TICW-RFA group were less than those of the SC-RFA group. No procedure-related death or major complications occurred. Technical success was achieved in all patients in both groups, and technique efficacy rates were 100% (46/46) in the TICW-RFA group and 95.0% (38/40) in the SC-RFA group (p = 0.213). The 1-year and 2-year cumulative LTP rates were 11.8% and 24.2%, respectively, in the TICW-RFA group, and 8.6% and 18.1%, respectively, in the SC-RFA group (p = 0.661).
CONCLUSION


In this single-center randomized controlled study from a Korean tertiary referral hospital, TICW-RFA demonstrated similar therapeutic efficacy and safety profile for recurrent HCC after locoregional treatment compared with SC-RFA.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03806218).",2020,"The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577).","['eligible patients with recurrent HCC after locoregional treatment, to receive', 'recurrent hepatocellular carcinoma after locoregional treatment', 'recurrent hepatocellular carcinoma (HCC) after locoregional treatment']","['Radiofrequency ablation using internally cooled wet electrodes', 'TICW-RFA or SC-RFA', 'SC-RFA', 'bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes', 'TICW-RFA']","['minimum diameter of the ablation zone per unit ablation time', 'technique efficacy rates', 'technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes', 'Technical success', '1-year and 2-year cumulative LTP rates', 'Total RF energy delivery', 'energy delivery per unit time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861876', 'cui_str': 'Hepatocellular carcinoma recurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",,0.066154,"The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577).","[{'ForeName': 'Jae Won', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jung-Hwan', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Su Jong', 'Initials': 'SJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Eun Ju', 'Initials': 'EJ', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239733']
3313,32986868,"Safety, pharmacokinetics and pharmacodynamics of BI 705564, a highly selective, covalent inhibitor of Bruton's tyrosine kinase, in Phase I clinical trials in healthy volunteers.","AIMS


To evaluate the safety, pharmacokinetics and pharmacodynamics of single- and multiple-rising doses (MRDs) of BI 705564 and establish proof of mechanism.
METHODS


BI 705564 was studied in 2 placebo-controlled, Phase I clinical trials testing single-rising doses (1-160 mg) and MRDs (1-80 mg) of BI 705564 over 14 days in healthy male volunteers. Blood samples were analysed for BI 705564 plasma concentration, Bruton's tyrosine kinase (BTK) target occupancy (TO) and CD69 expression in B cells stimulated ex vivo. A substudy was conducted in allergic, otherwise healthy, MRD participants. Safety was assessed in both studies.
RESULTS


All doses of BI 705564 were well tolerated. Geometric mean BI 705564 plasma terminal half-life ranged from 10.1 to 16.9 hours across tested doses, with no relevant accumulation after multiple dosing. Doses ≥20 mg resulted in ≥85% average TO that was maintained for ≥48 hours after single-dose administration. Functional effects of BTK signalling were demonstrated by dose-dependent inhibition of CD69 expression. In allergic participants, BI 705564 treatment showed a trend in wheal size reduction in a skin prick test and complete inhibition of basophil activation. Mild bleeding-related adverse events were observed with BI 705564; bleeding time increased in 1/12 participants (8.3%) who received placebo vs 26/48 (54.2%) treated with BI 705564.
CONCLUSION


BI 705564 showed efficient target engagement through durable TO and inhibition of ex vivo B-cell activation, and proof of mechanism through effects on allergic skin responses. Mild bleeding-related adverse events were probably related to inhibition of platelet aggregation by BTK inhibition.",2020,"In allergic participants, BI 705564 treatment showed a trend in wheal size reduction in a skin prick test and complete inhibition of basophil activation.","['BI 705564 was studied in two', 'A sub-study was conducted in allergic, otherwise healthy, MRD participants', 'male healthy volunteers', 'healthy volunteers']","['single- and multiple-rising doses (SRDs/MRDs', 'placebo', 'MRDs']","['Safety', 'Safety, pharmacokinetics and pharmacodynamics', 'wheal size reduction', 'Geometric mean BI 705564 plasma terminal half-life', 'bleeding time', ""BI 705564 plasma concentration, Bruton's tyrosine kinase (BTK) target occupancy (TO) and CD69 expression"", 'skin prick test and complete inhibition of basophil activation', 'Mild bleeding-related adverse events', 'safety, pharmacokinetics and pharmacodynamics', 'tolerated']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0268468', 'cui_str': 'Sepiapterin reductase deficiency'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0221232', 'cui_str': 'Weal'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0218158', 'cui_str': ""Bruton's Tyrosine Kinase""}, {'cui': 'C0108800', 'cui_str': 'Lymphocyte antigen CD69'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0004827', 'cui_str': 'Basophils'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",705564.0,0.0669878,"In allergic participants, BI 705564 treatment showed a trend in wheal size reduction in a skin prick test and complete inhibition of basophil activation.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Litzenburger', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Steffgen', 'Affiliation': 'Boehringer Ingelheim International GmbH, Biberach, Germany.'}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Benediktus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schultz', 'Affiliation': 'CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Klein', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Ramanujam', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Harcken', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Wiebe', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Xiujiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Flack', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Padula', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Sudha', 'Initials': 'S', 'LastName': 'Visvanathan', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hünnemeyer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14571']
3314,32991946,The feasibility of a personality targeted intervention for addictive overeating: FoodFix.,"Recent reviews have identified potential treatment targets for addictive overeating. These include: motivational interviewing, development of specific coping strategies for emotional regulation and the use of harm minimisation strategies based on interventions for substance use disorders. However, there is very little experiential evidence. The aim of this study was to determine the feasibility of a personality-targeted motivational interviewing intervention in adults above the healthy-weight range with symptoms of addictive eating, to reduce symptoms of addictive overeating and improve dietary profiles. Individuals with overweight and obesity (BMI >25 kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS) were recruited to a three-session intervention held over 3 months. Sessions were conducted by telehealth and facilitated by dietitians. Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ± 12.2yrs, mean BMI 36.7 ± 6.8 kg/m 2 , 96% female). At three month follow up, there were significant reductions from baseline (BL) for both groups in total YFAS 2.0 symptoms, however, these changes were not significantly different between groups (intervention BL 8.0 ± 2.7; 3-months 6.5 ± 3.8, control BL 8.1 ± 2.5; 3-months 6.9 ± 3.9, p > 0.05). At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p < 0.01). The FoodFix intervention provides insight to the development of future management interventions for addictive eating.",2021,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","['Individuals with overweight and obesity (BMI >25kg/m 2 ) with addictive eating as defined by the modified Yale Food Addiction Scale (mYFAS', 'Fifty-two individuals were randomised to either intervention or control (mean age 43.6 ±12.2yrs, mean BMI 36.7±6.8kg/m 2 , 96% female', 'adults above the healthy-weight range with symptoms of addictive eating']","['personality-targeted motivational interviewing intervention', 'FoodFix intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],52.0,0.0215587,"At 3 months the intervention group significantly reduced their energy from non-core foods compared with control (intervention BL 48% energy/day; 3-months 38%, control BL 41% energy/day; 3-months 38%, p<0.01).","[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Burrows', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: Tracy.Burrows@newcastle.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: rebecca.collins10@newcastle.edu.au.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rollo', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: megan.rollo@newcastle.edu.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Leary', 'Affiliation': 'School of Health Sciences, Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, 2308, NSW, Australia. Electronic address: mark.leary@uon.edu.au.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, NSW, Australia. Electronic address: l.hides@uq.edu.au.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'School of Kinesiology and Health Sciences, York University, Toronto, Canada. Electronic address: cdavis@yorku.ca.'}]",Appetite,['10.1016/j.appet.2020.104974']
3315,32996064,"Healthcare Resource Utilization of Ceftolozane/Tazobactam Versus Meropenem for Ventilated Nosocomial Pneumonia from the Randomized, Controlled, Double-Blind ASPECT-NP Trial.","INTRODUCTION


Hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) are associated with significant healthcare resource utilization (HCRU). This a priori, exploratory, secondary analysis from the ASPECT-NP clinical trial evaluated resource utilization among patients with ventilated HABP (vHABP)/VABP treated with ceftolozane/tazobactam or meropenem.
METHODS


This analysis used data from the randomized, double-blind, noninferiority phase 3 ASPECT-NP trial of patients with vHABP/VABP randomized to receive ceftolozane/tazobactam 3 g (ceftolozane 2 g/tazobactam 1 g) or meropenem 1 g for 8-14 days. Day 28 outcomes included hospital length of stay (LOS), intensive care unit (ICU) LOS, and time to mechanical ventilation extubation in the microbiological intention-to-treat (mITT) population and in an HCRU population. The HCRU population, a subset of patients from the mITT population that were alive at day 28, was used to remove resource use bias influenced by mortality rates.
RESULTS


Ceftolozane/tazobactam-treated versus meropenem-treated patients, respectively, had fewer deaths (20.1% vs. 25.5%), fewer hospital discharges (30.7% vs. 32.4%), and higher ICU discharges (60.0% vs. 58.3%) and extubations (51.9% vs. 48.2%) by day 28. In the HCRU population, adjusted LOS differences (95% confidence intervals) for ceftolozane/tazobactam compared with meropenem were 0.1 (- 1.4 to 1.6) hospitalization days, - 1.4 (- 2.9 to 0.2) ICU days, and - 0.9 (- 2.4 to 0.7) mechanical ventilation days. Patterns were similar among the VABP and Pseudomonas aeruginosa subgroups.
CONCLUSION


Similar 28-day resource utilization outcomes were observed between ceftolozane/tazobactam and meropenem in the mITT population of patients from ASPECT-NP with vHABP/VABP due to gram-negative pathogens. ASPECT-NP was not powered to detect differences in resource utilization outcomes between treatment groups; however, numerical differences in ICU LOS and duration of mechanical ventilation were noted. Further study is needed to assess resource utilization in the real-world practice setting, especially among patients excluded from ASPECT-NP, including those with resistant P. aeruginosa infections.
TRIAL REGISTRATIONS


ClinicalTrials.gov: NCT02070757, registered February 25, 2014; EudraCT: 2012-002862-11.",2020,Hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) are associated with significant healthcare resource utilization (HCRU).,"['Ventilated Nosocomial Pneumonia', 'patients with ventilated HABP (vHABP)/VABP treated with', 'patients with vHABP/VABP randomized to receive']","['ceftolozane/tazobactam 3', 'ceftolozane/tazobactam or meropenem', 'Ceftolozane/Tazobactam Versus Meropenem', 'meropenem', 'ceftolozane/tazobactam', 'g (ceftolozane 2\xa0g/tazobactam 1', 'Ceftolozane/tazobactam']","['Hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP', 'mortality rates', 'deaths', 'hospital length of stay (LOS), intensive care unit (ICU) LOS, and time to mechanical ventilation extubation in the microbiological intention-to-treat (mITT) population and in an HCRU population', 'ICU LOS and duration of mechanical ventilation', 'hospital discharges', '28-day resource utilization outcomes', 'ICU discharges']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4727976', 'cui_str': 'Ventilated HABP'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2189270', 'cui_str': 'VABP'}]","[{'cui': 'C3656593', 'cui_str': 'Ceftolozane and tazobactam'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C3852726', 'cui_str': 'ceftolozane'}, {'cui': 'C0075870', 'cui_str': 'tazobactam'}]","[{'cui': 'C0456393', 'cui_str': 'Hospital acquired'}, {'cui': 'C2189270', 'cui_str': 'VABP'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.501391,Hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) are associated with significant healthcare resource utilization (HCRU).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lodise', 'Affiliation': 'Albany College of Pharmacy and Health Sciences, Albany, NY, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Puzniak', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Laura.puzniak@merck.com.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dillon', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kollef', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00343-0']
3316,32993832,Implementing a package of noncommunicable disease interventions in the Republic of Moldova: two-year follow-up data.,"Noncommunicable diseases (NCDs) are a growing challenge in the Republic of Moldova. A previously reported pilot cluster randomized controlled trial aimed to determine the feasibility of implementing and evaluating essential interventions for NCDs (e.g. cardiovascular risk scoring, hypertension management, statin treatment, etc.) in primary health care in the Republic of Moldova, with a view toward national scale up. One-year follow-up data (previously published) demonstrated modest improvements in NCD risk factor identification and management could be achieved. Herein, we report the second-year follow-up data and conclude that sustainable improvements in NCD risk factor control (e.g. hypertension control) can be achieved in primary health care in low resource settings by adapting existing resources (e.g. WHO PEN) and conducting focused clinical training and support. If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.",2020,"If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.",[],[],[],[],[],[],,0.0278124,"If scaled to a national level, these improvements in risk factor control could significantly translate to reductions in premature mortality from NCDs.","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Inglin', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ciobanu', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Ghenadie', 'Initials': 'G', 'LastName': 'Curocichin', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Salaru', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zatic', 'Affiliation': 'Primary, Emergency and Community Health Policies Department, Ministry of Health, Labour and Social Protection, Chisinau, Republic of Moldova.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Anisei', 'Affiliation': 'Department on Quality Management of Health Services, National Public Health Agency, Chisinau, Republic of Moldova.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chiosa', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Munteanu', 'Affiliation': 'Family Medicine Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Zinaida', 'Initials': 'Z', 'LastName': 'Alexa', 'Affiliation': 'Endocrinology Department, Nicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",Primary health care research & development,['10.1017/S1463423620000420']
3317,33000762,Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents: Protocol for a Mixed-Design Evaluation.,"BACKGROUND


Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent's commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves.
OBJECTIVE


To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program's implementation.
METHODS


A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the experiment with that of a convenience sample of schools that were not part of the experimental study. Diverse secondary outcomes at both adolescent and adult levels were also included.
RESULTS


The study was approved by the Umeå Regional Ethics Review Board (registration number 2017/255-31) in 2017. Recruitment of schools started in fall 2017 and continued until June 2018. In total, 43 schools were recruited to the experimental study, and 16 schools were recruited to the observational study. Data collection started in the fall 2018, is ongoing, and is planned to be finished in spring 2021.
CONCLUSIONS


Methodological, ethical, and practical implications of the evaluation protocol were discussed, especially the advantage of combining several sources of data, to triangulate the study questions. The results of these studies will help revise the agenda of this program as well as those of similar programs.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 52858080; https://doi.org/10.1186/ISRCTN52858080.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/21100.",2020,"Primary outcome at the adolescent level was identified as ""not having tried tobacco"" during the three-year junior high school compulsory grades (12-15 years of age).","['adolescents and/or promoting cessation among their parents', 'In total 43 schools were recruited to the experimental study and 16 schools were recruited to the observational study', 'schools participating in the experiment with that of a convenience sample of schools not being part of the experimental study']","['Swedish school-based program ""Tobacco-free Duo"" (TOPAS study', 'comprehensive multi-component program or to its educational component only']","['smoking prevalence', 'adolescent level was identified as ""not having tried tobacco']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205171', 'cui_str': 'Singular'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]",43.0,0.0328951,"Primary outcome at the adolescent level was identified as ""not having tried tobacco"" during the three-year junior high school compulsory grades (12-15 years of age).","[{'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Galanti', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anni-Maria', 'Initials': 'AM', 'LastName': 'Pulkki-Brännström', 'Affiliation': 'Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Epidemiology and Global Health, Umeå University, Umeå, Sweden.'}]",JMIR research protocols,['10.2196/21100']
3318,32997575,Five-Year Outcomes With Nivolumab in Patients With Wild-Type  BRAF  Advanced Melanoma.,"PURPOSE


The CheckMate 066 trial investigated nivolumab monotherapy as first-line treatment for patients with previously untreated  BRAF  wild-type advanced melanoma. Five-year results are presented herein.
PATIENTS AND METHODS


In this multicenter, double-blind, phase III study, 418 patients with previously untreated, unresectable, stage III/IV, wild-type  BRAF  melanoma were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or dacarbazine 1,000 mg/m 2  every 3 weeks. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.
RESULTS


Patients were followed for a minimum of 60 months from the last patient randomly assigned (median follow-up, 32.0 months for nivolumab and 10.9 months for dacarbazine). Five-year OS rates were 39% with nivolumab and 17% with dacarbazine; PFS rates were 28% and 3%, respectively. Five-year OS was 38% in patients randomly assigned to dacarbazine who had subsequent therapy, including nivolumab (n = 37). ORR was 42% with nivolumab and 14% with dacarbazine; among patients alive at 5 years, ORR was 81% and 39%, respectively. Of 42 patients treated with nivolumab who had a complete response (20%), 88% (37 of 42) were alive as of the 5-year analysis. Among 75 nivolumab-treated patients alive and evaluable at the 5-year analysis, 83% had not received subsequent therapy; 23% were still on study treatment, and 60% were treatment free. Safety analyses were similar to the 3-year report.
CONCLUSION


Results from this 5-year analysis confirm the significant benefit of nivolumab over dacarbazine for all end points and add to the growing body of evidence supporting long-term survival with nivolumab mono-therapy. Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.",2020,"Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.","['418 patients with previously untreated, unresectable, stage III/IV, wild-type  BRAF  melanoma', 'patients with previously untreated  BRAF  wild-type advanced melanoma', 'Patients With Wild-Type  BRAF  Advanced Melanoma']","['nivolumab monotherapy', 'nivolumab 3 mg/kg every 2 weeks or dacarbazine', 'Nivolumab', 'dacarbazine']","['PFS rates', 'ORR', 'Survival', 'complete response', 'overall survival (OS), and secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety', 'Five-year OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}]",418.0,0.559944,"Survival is strongly associated with achieving a durable response, which can be maintained after treatment discontinuation, even without subsequent systemic therapies.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brady', 'Affiliation': 'Cabrini Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Hôpital Saint André Centre Hospitalier Universitaire, Bordeaux, France.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'University of Lille, INSERM U1189, Service de Dermatologie, Chu Lille, Lille, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Hassel', 'Affiliation': 'National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse, Melanoma Institute Australia, and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Ewa Anna', 'Initials': 'EA', 'LastName': 'Kalinka', 'Affiliation': ""Polish Mother's Memorial Hospital-Research Institute, Lodz, Poland.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM U976, and Dermatology and CIC, AP-HP, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'Grenoble Alpes University Hospital, INSERM U1209, Grenoble Alpes University, Grenoble, France.'}, {'ForeName': 'Micaela M', 'Initials': 'MM', 'LastName': 'Hernberg', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'British Columbia Cancer Agency, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Oncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Mihalcioiu', 'Affiliation': 'Royal Victoria Hospital, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Mauch', 'Affiliation': 'University Hospital Cologne and Centrum für Integrierte Onkologie Köln, Bonn, Germany.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clínic Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cognetti', 'Affiliation': 'Regina Elena Institute, Rome, Italy.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ny', 'Affiliation': 'Department of Oncology, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, Comprehensive Cancer Center, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Zoco', 'Affiliation': ""Syneos Health, Braine l'Alleud, Belgium.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Re', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, Woolloongabba, and Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Greenslopes, Queensland, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00995']
3319,33020052,Intratrial Exposure to Vitamin D and New-Onset Diabetes Among Adults With Prediabetes: A Secondary Analysis From the Vitamin D and Type 2 Diabetes (D2d) Study.,"OBJECTIVE


Postrandomization biases may influence the estimate of efficacy of supplemental vitamin D in diabetes prevention trials. In the Vitamin D and Type 2 Diabetes (D2d) study, repeated measures of serum 25-hydroxyvitamin D [25(OH)D] level provided an opportunity to test whether intratrial vitamin D exposure affected diabetes risk and whether the effect was modified by trial assignment (vitamin D vs. placebo).
RESEARCH DESIGN AND METHODS


The D2d study compared the effect of daily supplementation with 100 μg (4,000 units) of vitamin D 3  versus placebo on new-onset diabetes in adults with prediabetes. Intratrial vitamin D exposure was calculated as the cumulative rolling mean of annual serum 25(OH)D measurements. Hazard ratios for diabetes among participants who had intratrial 25(OH)D levels of <50, 75-99, 100-124, and ≥125 nmol/L were compared with those with levels of 50-74 nmol/L (the range considered adequate by the National Academy of Medicine) in the entire cohort and by trial assignment.
RESULTS


There was an interaction of trial assignment with intratrial 25(OH)D level in predicting diabetes risk (interaction  P  = 0.018). The hazard ratio for diabetes for an increase of 25 nmol/L in intratrial 25(OH)D level was 0.75 (95% CI 0.68-0.82) among those assigned to vitamin D and 0.90 (0.80-1.02) among those assigned to placebo. The hazard ratios for diabetes among participants treated with vitamin D who maintained intratrial 25(OH)D levels of 100-124 and ≥125 nmol/L were 0.48 (0.29-0.80) and 0.29 (0.17-0.50), respectively, compared with those who maintained a level of 50-74 nmol/L.
CONCLUSIONS


Daily vitamin D supplementation to maintain a serum 25(OH)D level ≥100 nmol/L is a promising approach to reducing the risk of diabetes in adults with prediabetes.",2020,There was an interaction of trial assignment with intratrial 25(OH)D level in predicting diabetes risk (interaction  P  = 0.018).,"['adults with prediabetes', 'Adults With Prediabetes']","['intratrial vitamin D', 'vitamin D', 'supplemental vitamin D', 'vitamin D 3  versus placebo', 'placebo', 'Intratrial Exposure to Vitamin D and New-Onset Diabetes']","['intratrial 25(OH)D level', 'serum 25-hydroxyvitamin D [25(OH)D] level', 'hazard ratios for diabetes', 'Hazard ratios for diabetes', 'hazard ratio for diabetes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",,0.453158,There was an interaction of trial assignment with intratrial 25(OH)D level in predicting diabetes risk (interaction  P  = 0.018).,"[{'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA.'}, {'ForeName': 'Myrlene A', 'Initials': 'MA', 'LastName': 'Staten', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Vickery', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'LeBlanc', 'Affiliation': 'Kaiser Permanente Center for Health Research Northwest, Portland, OR.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Neff', 'Affiliation': 'Division of Endocrinology, Metabolism, and Molecular Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1765']
3320,33017434,Whole-body protein kinetics in critically ill patients during 50 or 100% energy provision by enteral nutrition: A randomized cross-over study.,"BACKGROUND


Enteral nutrition (EN) is a ubiquitous intervention in ICU patients but there is uncertainty regarding the optimal dose, timing and importance for patient-centered outcomes during critical illness. Our research group has previously found an improved protein balance during normocaloric versus hypocaloric parenteral nutrition in neurosurgical ICU patients. We now wanted to investigate if this could be demonstrated in a general ICU population with established enteral feeding, including patients on renal replacement therapy.
METHODS


Patients with EN >80% of energy target as determined by indirect calorimetry were randomized to or 50% or 100% of current EN rate. After 24 hours, whole-body protein kinetics were determined by enteral and parenteral stable isotope tracer infusions. Treatment allocation was then switched, and tracer investigations repeated 24 hours later in a crossover design with patients serving as their own controls.
RESULTS


Six patients completed the full protocol. During feeding with 100% EN all patients received >1.2 g/kg/day of protein. Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044). The oxidation rate of phenylalanine was unaltered (p = 0.78).
CONCLUSIONS


It is possible to assess whole-body protein turnover using a stable isotope technique in critically ill patients during enteral feeding and renal replacement therapy. Our results also suggest a better whole-body protein balance during full dose as compared to half dose EN. As the sample size was smaller than anticipated, this finding should be confirmed in larger studies.",2020,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"['neurosurgical ICU patients', 'ICU patients', 'Patients with EN >80% of energy target as determined by indirect calorimetry', 'general ICU population with established enteral feeding, including patients on renal replacement therapy', 'critically ill patients during enteral feeding and renal replacement therapy', 'critically ill patients during 50 or 100% energy provision by enteral nutrition']",['Enteral nutrition (EN'],"['Mean whole-body protein balance', 'protein balance', 'oxidation rate of phenylalanine']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}]",,0.0217836,Mean whole-body protein balance increased from -6.07 to 2.93 µmol phenylalanine/kg/h during 100% EN as compared to 50% (p = 0.044).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sundström Rehal', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Liebau', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Wernerman', 'Affiliation': 'Division of Anesthesia and Intensive Care, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Rooyackers', 'Affiliation': 'Department of Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",PloS one,['10.1371/journal.pone.0240045']
3321,33021328,[Should all patients with traumatic brain injury receive tranexamic acid?],"Traumatic brain injury (TBI) is a leading cause of death and disability. Progressive intracranial bleeding is common in TBI and worsens outcome. The multicentre, randomized placebo-controlled CRASH-3 study enrolling 12,737 patients showed that early, <3h, administration of tranexamic acid (TXA) decreased mortality in mild-moderate TBI patients. In accordance with large previous trials, thromboembolic complications were not increased. In view of the favourable safety profile of TXA and the devastating effects from intracranial bleeds, the authors argue that TXA be administered within 3h post-injury to moderate-severe TBI patients, and in mild TBI to those with intracranial haemorrhage on acute CT.",2020,"In accordance with large previous trials, thromboembolic complications were not increased.","['mild-moderate TBI patients', 'patients with traumatic brain injury receive', 'Traumatic brain injury (TBI']","['TXA', 'tranexamic acid (TXA', 'placebo', 'tranexamic acid']",['thromboembolic complications'],"[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",12737.0,0.267762,"In accordance with large previous trials, thromboembolic complications were not increased.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rostami', 'Affiliation': 'docent, specialistläkare, institutionen för neurovetenskap/neurokirurgi, Uppsala universitet; medlem i European Association of Neurosurgical Societies (EANS) sektion för trauma- och intensivvård; ordförande för Yngre neurokir-urger.'}, {'ForeName': 'Poul', 'Initials': 'P', 'LastName': 'Kongstad', 'Affiliation': '.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Marklund', 'Affiliation': 'professor, överläkare, Lunds universitet; Skånes universitetssjukhus, Lund; ordförande för EANS sektion för trauma- och intensivvård.'}]",Lakartidningen,[]
3322,33021404,The Clinical Application of the Deep Learning Technique for Predicting Trigger Origins in Patients With Paroxysmal Atrial Fibrillation With Catheter Ablation.,"BACKGROUND


Non-pulmonary vein (NPV) trigger has been reported as an important predictor of recurrence post-atrial fibrillation ablation. Elimination of NPV triggers can reduce the recurrence of postablation atrial fibrillation. Deep learning was applied to preablation pulmonary vein computed tomography geometric slices to create a prediction model for NPV triggers in patients with paroxysmal atrial fibrillation.
METHODS


We retrospectively analyzed 521 patients with paroxysmal atrial fibrillation who underwent catheter ablation of paroxysmal atrial fibrillation. Among them, pulmonary vein computed tomography geometric slices from 358 patients with nonrecurrent atrial fibrillation (1-3 mm interspace per slice, 20-200 slices for each patient, ranging from the upper border of the left atrium to the bottom of the heart, for a total of 23 683 images of slices) were used in the deep learning process, the ResNet34 of the neural network, to create the prediction model of the NPV trigger. There were 298 (83.2%) patients with only pulmonary vein triggers and 60 (16.8%) patients with NPV triggers±pulmonary vein triggers. The patients were randomly assigned to either training, validation, or test groups, and their data were allocated according to those sets. The image datasets were split into training (n=17 340), validation (n=3491), and testing (n=2852) groups, which had completely independent sets of patients.
RESULTS


The accuracy of prediction in each pulmonary vein computed tomography image for NPV trigger was up to 82.4±2.0%. The sensitivity and specificity were 64.3±5.4% and 88.4±1.9%, respectively. For each patient, the accuracy of prediction for a NPV trigger was 88.6±2.3%. The sensitivity and specificity were 75.0±5.8% and 95.7±1.8%, respectively. The area under the curve for each image and patient were 0.82±0.01 and 0.88±0.07, respectively.
CONCLUSIONS


The deep learning model using preablation pulmonary vein computed tomography can be applied to predict the trigger origins in patients with paroxysmal atrial fibrillation receiving catheter ablation. The application of this model may identify patients with a high risk of NPV trigger before ablation.",2020,The accuracy of prediction in each PVCT image for NPV trigger was up to 82.4±2.0%.,"['patients with paroxysmal atrial fibrillation (PAF', '521 PAF patients who underwent', 'patients with a high risk of NPV trigger before ablation', 'There were 298 (83.2%) patients with only pulmonary vein (PV) triggers and 60 (16.8%) patients with NPV triggers ', 'Paroxysmal Atrial Fibrillation Patients with Catheter Ablation', 'PAF patients receiving catheter ablation']","['Deep learning was applied to pre-ablation pulmonary vein computed tomography (PVCT) geometric slices', 'catheter ablation of PAF', 'Deep Learning Technique']","['sensitivity and specificity', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0032172', 'cui_str': 'Platelet activating factor'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",23683.0,0.0165084,The accuracy of prediction in each PVCT image for NPV trigger was up to 82.4±2.0%.,"[{'ForeName': 'Chih-Min', 'Initials': 'CM', 'LastName': 'Liu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Shih-Lin', 'Initials': 'SL', 'LastName': 'Chang', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Hung-Hsun', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology (M.-H.W., C.-K.C., Y.-Y.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Wei-Shiang', 'Initials': 'WS', 'LastName': 'Chen', 'Affiliation': 'Institute of Statistics (W.-S.C., H.H.-S.L.), National Chiao Tung University, Hsinchu, Taiwan.'}, {'ForeName': 'Yenn-Jiang', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Lo', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Hu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Fa-Po', 'Initials': 'FP', 'LastName': 'Chung', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Tze-Fan', 'Initials': 'TF', 'LastName': 'Chao', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Ta-Chuan', 'Initials': 'TC', 'LastName': 'Tuan', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Jo-Nan', 'Initials': 'JN', 'LastName': 'Liao', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Chin-Yu', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Ting-Yung', 'Initials': 'TY', 'LastName': 'Chang', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Cheng-I', 'Initials': 'CI', 'LastName': 'Wu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Kuo', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Mei-Han', 'Initials': 'MH', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, School of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., L.K., M.-H.W., C.-K.C.), National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chun-Ku', 'Initials': 'CK', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology (M.-H.W., C.-K.C., Y.-Y.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Ying-Yueh', 'Initials': 'YY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiology (M.-H.W., C.-K.C., Y.-Y.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Yang-Che', 'Initials': 'YC', 'LastName': 'Shiu', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Henry Horng-Shing', 'Initials': 'HH', 'LastName': 'Lu', 'Affiliation': 'Institute of Statistics (W.-S.C., H.H.-S.L.), National Chiao Tung University, Hsinchu, Taiwan.'}, {'ForeName': 'Shih-Ann', 'Initials': 'SA', 'LastName': 'Chen', 'Affiliation': 'Heart Rhythm Center, Division of Cardiology, Department of Medicine (C.-M.L., S.-L.C., Y.-J.L., L.-W.L., Y.-F.H., F.-P.C., T.-F.C., T.-C.T., J.-N.L., C.-Y.L., T.-Y.C., C.-I.W., L.K., Y.-C.S., S.-A.C.), Taipei Veterans General Hospital, Taiwan.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008518']
3323,33022318,Treating tobacco dependence to aid re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION


U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS


Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS


Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS


In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Cati', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
3324,33022321,Use of a GP-endorsed non-participant reminder letter to promote uptake of bowel scope screening: A randomised controlled trial in a hard-to-reach population.,"Previous research suggests that sending non-participants a reminder letter, 1 year after their initial invitation, can improve coverage for bowel scope screening (BSS), also known as flexible sigmoidoscopy screening. We hypothesised that adding a general practitioner's (GPs) endorsement to the reminder letter could improve coverage even further. We conducted a randomised controlled trial in North West London, UK. Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12 months prior to the trial period. Eligible adults were randomised in a 1:1 ratio to receive either a GP-endorsed reminder letter, or a standard reminder letter from June to August 2019. Logistic regression models were used to test the effect of the GP endorsement on attendance at BSS, adjusting for sex, clinical commissioning group, and local area socioeconomic deprivation. In total, 1200 participants were enrolled into the study and randomised to either the control (n = 600) or the intervention (n = 600) group. Those who received the GP-endorsed reminder letter were only slightly more likely to attend BSS than those who received the standard reminder letter (4% vs. 3%); this difference was not statistically significant (Adjusted OR = 1.30; 95% CI: 0.69, 2.43). Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS. One possible explanation for this is that the endorsement used was not personalised enough. Future research should examine stronger GP-endorsements or other methods to promote uptake.",2020,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"['Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12\u202fmonths prior to the trial period', 'North West London, UK', 'Eligible adults', '1200 participants were enrolled into the study and randomised to either the control (n\u202f=\u202f600) or the intervention (n\u202f=\u202f600) group']","['GP-endorsed reminder letter, or a standard reminder letter from June to August 2019', 'GP-endorsed non-participant reminder letter']",[],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],1200.0,0.121819,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK. Electronic address: aradhna.kaushal.14@ucl.ac.uk.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tookey', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106268']
3325,33022324,Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
3326,33025010,Associations between Diet Quality and Body Composition in Young Children Born with Very Low Body Weight.,"BACKGROUND


Very low birth weight (VLBW; <1500 g) infants have increased adiposity and metabolic disease risk in adulthood. Limited evidence suggests low-quality childhood diets are a predisposing risk factor. Despite this, to our knowledge no study has yet examined associations between diet quality and body composition in VLBW individuals.
OBJECTIVE


The objective of this study was to determine associations between Healthy Eating Index-2010 (HEI-2010) scores and consumption of fruits/vegetables, added sugars, and macronutrients with body composition in 5.5-y-old children born VLBW. We hypothesized HEI-2010 scores were inversely associated with adiposity.
METHODS


This cohort study leveraged the 5.5-y follow-up to the Donor Milk for Improved Neurodevelopmental Outcomes randomized controlled trial. From June 2016 to July 2018, participants attended a follow-up visit at The Hospital for Sick Children, Canada, or were visited in their home. All 316 surviving infants from the trial were eligible, and the caregivers of 158 children (50%; 53% male) consented to follow-up. Diet quality (HEI-2010) and usual intake of fruits/vegetables, added sugars, and macronutrients were determined from two 24-h dietary recalls (ASA24). Linear regressions evaluated associations of diet with BMI (kg/m2) and waist circumference z-scores, total fat, fat-free mass (air displacement plethysmography), and skinfolds.
RESULTS


Mean ± SD age at follow-up was 5.7 ± 0.2 y, birth weight was 1013 ± 264 g, and gestational age was 27.9 ± 2.5 wk. Dietary data and BMI z-scores were available for all children; 123 completed air displacement plethysmography. HEI-2010 score was 58.2 ± 12.4 out of 100, and 27% of children had poor quality diets (scores ≤50). HEI-2010 scores were inversely associated with BMI z-score, but only in children with obese mothers. A 10-point increase in HEI-2010 score was associated with reduced BMI (β: -0.5 SD; 95% CI: -0.7, -0.2) and subscapular (-0.3 SD; 95% CI: -0.6, -0.06) z-scores.
CONCLUSIONS


Improving diet quality in children born VLBW with obese mothers may be an important strategy to prevent excess adiposity. This trial was registered at clinicaltrials.gov as Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 1-Impact of Donor Milk at Kindergarten, NCT02759809.",2020,"A 10-point increase in HEI-2010 score was associated with reduced BMI (β: -0.5 SD; 95% CI: -0.7, -0.2) and subscapular (-0.3 SD; 95% CI: -0.6, -0.06) z-scores.
","['5.5-y-old children born VLBW', 'From June 2016 to July 2018, participants attended a follow-up visit at The Hospital for Sick Children, Canada, or were visited in their home', 'All 316 surviving infants from the trial were eligible, and the caregivers of 158 children (50%; 53% male) consented to follow-up', 'Mean ± SD age at follow-up was 5.7 ± 0.2 y, birth weight was 1013 ± 264 g, and gestational age was 27.9 ± 2.5 wk', 'children born VLBW with obese mothers', 'children with obese mothers', 'Very low birth weight (VLBW', 'Young Children Born with Very Low Body Weight']",[],"['HEI-2010 scores', 'BMI z-score', 'Diet Quality and Body Composition', 'HEI-2010 score', 'Dietary data and BMI z-scores', 'diet with BMI (kg/m2) and waist circumference z-scores, total fat, fat-free mass (air displacement plethysmography), and skinfolds', 'poor quality diets', 'adiposity and metabolic disease risk', 'Healthy Eating Index-2010 (HEI-2010) scores and consumption of fruits/vegetables, added sugars, and macronutrients with body composition', 'Diet quality (HEI-2010) and usual intake of fruits/vegetables, added sugars, and macronutrients']","[{'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.114928,"A 10-point increase in HEI-2010 score was associated with reduced BMI (β: -0.5 SD; 95% CI: -0.7, -0.2) and subscapular (-0.3 SD; 95% CI: -0.6, -0.06) z-scores.
","[{'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'McGee', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Unger', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Hamilton', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Birken', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zdenka', 'Initials': 'Z', 'LastName': 'Pausova', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bando', 'Affiliation': 'Translational Medicine Program, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa281']
3327,32977202,The differential impact of viewing fitspiration and thinspiration images on men's body image concerns: An experimental ecological momentary assessment study.,"To date, little is known about the impact of fitspiration and thinspiration exposure on men, as previous studies on these social media trends were primarily conducted on women. Male participants (n = 223) completed baseline measures of trait body image, then used a smartphone application to complete up to six state-based assessments daily for seven days. In each assessment, participants were randomly assigned to one of three image conditions (fitspiration, thinspiration, or neutral). Before and after viewing each image, they reported state body fat dissatisfaction, muscularity dissatisfaction, negative mood, and urge to engage in behaviours to reduce body fat and increase muscularity. Multi-level analyses revealed that compared to viewing neutral images, viewing fitspiration images increased men's body dissatisfaction, whereas viewing thinspiration images decreased body dissatisfaction. Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat. Men with greater baseline muscularity dissatisfaction and higher appearance comparison were most vulnerable to muscularity dissatisfaction after viewing fitspiration images. Findings suggest the importance of limiting exposure to fitspiration imagery and implementing social media literacy programmes for men and well as women.",2020,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","['men and well as women', 'Male participants (n = 223', ""men's body image concerns""]",['viewing fitspiration and thinspiration images'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],223.0,0.019817,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","[{'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Yee', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: zhiwei@student.unimelb.edu.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: scott.griffiths@unimelb.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, VIC, 3125, Australia; School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: matthew.fuller.tyszkiewicz@deakin.edu.au.'}, {'ForeName': 'Khandis', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: khandis.blake@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: Ben.Richardson@nousgroup.com.au.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: Isabel.krug@unimelb.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.08.008']
3328,32985145,Influence of the laser pulse shape in the treatment of stones in the upper urinary tract.,"PURPOSE


Urinary stones can be successfully treated using a Holmium: Yttrium-Aluminum-Garnet (Ho: YAG) laser. Regarding success rates, laser pulse energy, frequency, and pulse width are well-known contributing factors. Whether the pulse shape might be a further factor influencing the laser efficiency is unclear. This study aimed to evaluate different modes of laser pulse shapes in a real-world setting.
MATERIALS AND METHODS


The Dornier Medilas® H Solvo (Weßling, Germany) was used in the treatment of ureter and kidney stones. Patients were randomized into standard pulse shape (SPS) and new pulse shape groups (NPS1; ureter) and (NPS2; kidney pelvis), depending on the stone localization. The primary endpoint was laser efficiency defined as mm³ stone destruction per overall operating time. Secondary endpoints encompassed number of stone recoveries and stone-free rate.
RESULTS


Altogether 145 patients (24 SPS vs. 32 NPS1; 51 SPS vs. 38 NPS2) were included. No differences in sex, age, body mass index, stone localization and stone composition were found, except for preoperative stone size (133±95 [SPS] vs. 197±139 [NPS1] mm³; p=0.023) and (348±298 [SPS] vs. 525±429 [NPS2] mm³; p=0.042). Regarding the primary endpoint, a significant increase in laser efficiency could be detected for the NPS1 and NPS2 groups compared to the SPS groups (39.9±44.9 vs. 28.8±30.2 and 51.7±61.3 vs. 22.4±24.2 mm³/min [mean±standard deviation]). No statistically significant differences were found for secondary endpoints and perioperative complication rates.
CONCLUSIONS


Efficiency of the Ho: YAG laser can be positively influenced by different pulse shapes. This adds the variable of individualized intraoperative decision making.",2020,"Regarding the primary endpoint, a significant increase in laser efficiency could be detected for the NPS1 and NPS2 groups compared to the SPS groups (39.9±44.9 vs. 28.8±30.2 and 51.7±61.3 vs. 22.4±24.2",['Altogether 145 patients (24 SPS vs. 32 NPS1; 51 SPS vs. 38 NPS2) were included'],"['Holmium: Yttrium-Aluminum-Garnet ', 'standard pulse shape (SPS) and new pulse shape groups (NPS1; ureter) and (NPS2; kidney pelvis', 'laser pulse shape']","['sex, age, body mass index, stone localization and stone composition', 'success rates, laser pulse energy, frequency, and pulse width', 'perioperative complication rates', 'laser efficiency defined as mm³ stone destruction per overall operating time', 'laser efficiency', 'number of stone recoveries and stone-free rate']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0027341', 'cui_str': 'Nail-patella syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027341', 'cui_str': 'Nail-patella syndrome'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1289835', 'cui_str': 'Pulsed laser device'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0428447', 'cui_str': 'Determination of stone composition'}, {'cui': 'C1289835', 'cui_str': 'Pulsed laser device'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449790', 'cui_str': 'Number of stones'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",145.0,0.0242703,"Regarding the primary endpoint, a significant increase in laser efficiency could be detected for the NPS1 and NPS2 groups compared to the SPS groups (39.9±44.9 vs. 28.8±30.2 and 51.7±61.3 vs. 22.4±24.2","[{'ForeName': 'Abdulmajeed', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kretschmer', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Stief', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Strittmatter', 'Affiliation': 'Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany. frank.strittmatter@med.uni-muenchen.de.'}]",Investigative and clinical urology,['10.4111/icu.20200130']
3329,32980142,"[The effect of epinephrine for the treatment of spinal-hypotension: comparison with norepinephrine and phenylephrine, clinical trial].","BACKGROUND AND OBJECTIVES


Limited data are present on safety and efficiency of epinephrine for the prophylaxis and treatment of spinal-hypotension. This study was conducted to compare the effect of epinephrine with norepinephrine and phenylephrine on the treatment of spinal-hypotension and ephedrine requirement during cesarean delivery.
METHODS


One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited. They were allocated randomly to receive norepinephrine 5 μg.mL -1  (n=40), epinephrine 5 μg.mL -1  (n=40), phenylephrine 100 μg.mL -1  (n=40) or 0.9% saline infusions (n=40) immediately after induction of spinal anesthesia. Whenever systolic blood pressure drops to less than 80% of baseline, 5 mg of iv ephedrine was administered as rescue vasopressor. The incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects were recorded.
RESULTS


There was no statistically significant difference in incidence of maternal hypotension between groups. The number of patients requiring ephedrine was significantly greater in group saline than in group phenylephrine (p <0.001). However, it was similar between phenylephrine, norepinephrine, and epinephrine groups. The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
CONCLUSION


There is no statistically significant difference in incidence of hypotension and ephedrine consumption during spinal anesthesia for cesarean delivery with the use of epinephrine when compared to norepinephrine or phenylephrine. Epinephrine can be considered as an alternative agent for management of spinal hypotension.",2020,"The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
","['spinal-hypotension', 'One hundred and sixty parturients with uncomplicated pregnancies undergoing elective cesarean delivery under spinal anesthesia were recruited']","['epinephrine', 'phenylephrine, norepinephrine', 'norepinephrine, epinephrine, phenylephrine', 'ephedrine', 'Epinephrine', 'norepinephrine or phenylephrine', 'epinephrine with norepinephrine and phenylephrine', 'epinephrine 5\xa0μg.mL -1', 'norepinephrine and phenylephrine', 'phenylephrine 100\xa0μg.mL -1  (n=40) or 0.9% saline infusions', 'phenylephrine', 'norepinephrine\xa05\xa0μg.mL -1']","['hypotension and ephedrine consumption', 'incidence of maternal hypotension', 'number of patients requiring ephedrine', 'mean ephedrine consumption', 'incidence of hypotension, total number of hypotension episodes, the number of patients requiring ephedrine, the mean amount of ephedrine consumption and side effects', 'systolic blood pressure drops']","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]",160.0,0.351953,"The mean ephedrine consumption was significantly higher in group saline than in norepinephrine, epinephrine, phenylephrine groups (p=0.001).
","[{'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Biricik', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turquia. Electronic address: ebrubiricik01@gmail.com.'}, {'ForeName': 'Feride', 'Initials': 'F', 'LastName': 'Karacaer', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turquia.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Ünal', 'Affiliation': 'Çukurova University, Faculty of Medicine, Department of Statistics, Adana, Turquia.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Sucu', 'Affiliation': 'Çukurova University, Faculty of Medicine, Department of Obstetrics and Gynecology, Adana, Turquia.'}, {'ForeName': 'Hakkı', 'Initials': 'H', 'LastName': 'Ünlügenç', 'Affiliation': 'Cukurova University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Adana, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.017']
3330,32980184,"Pharmacokinetics and Tolerability of LC28-0126, a Novel Necrosis Inhibitor, After Multiple Ascending Doses: A Phase I Randomized, Double-blind, Placebo-controlled Study in Healthy Male Subjects.","PURPOSE


LC28-0126 is a reactive oxygen species scavenger being developed for the treatment of various conditions caused by oxidative stress, such as oral mucositis, graft-versus-host disease, and lethal reperfusion injury in acute myocardial infarction. The aim of this study was to assess the tolerability and pharmacokinetic properties of LC28-0126 with multiple IV administrations in healthy male subjects.
METHODS


A dose-block-randomized, double-blind, placebo-controlled, multiple ascending-dose study was conducted. Subjects received 3-, 10-, 20-, or 30-mg doses of LC28-0126 or inactive control vehicle, infused over 30 min, once daily for 7 days. Blood and urine samples were collected for pharmacokinetics assessment. Tolerability was assessed by the documentation of adverse events, including abnormal findings on physical examination, vital sign measurements, blood oxygen saturation monitoring, 12-lead ECG, continuous ECG monitoring, and clinical laboratory testing.
FINDINGS


A total of 32 subjects completed the study. After multiple dosing, the plasma concentration of LC28-0126 showed a steep decrease after infusion, followed by slow elimination. Systemic exposure of LC28-0126 was increased proportionally to doses ranging from 3 to 30 mg. The accumulation ratios were 2.58-2.79 on multiple dosing. The fractions excreted unchanged in urine were found to be <5%. All reported drug-related adverse events were injection-site reactions, and no serious adverse events were reported.
IMPLICATIONS


Multiple administrations of LC28-0126 exhibited a dose-proportional pharmacokinetic profile and were well tolerated at a dose range of 3-30 mg. ClinicalTrials.gov identifier: NCT03196804.",2020,Multiple administrations of LC28-0126 exhibited a dose-proportional pharmacokinetic profile and were well tolerated at a dose range of 3-30 mg.,"['healthy male subjects', 'Healthy Male Subjects', 'A total of 32 subjects completed the study']","['placebo', 'LC28-0126 or inactive control vehicle', 'Placebo', 'LC28']","['Pharmacokinetics and Tolerability', 'documentation of adverse events, including abnormal findings on physical examination, vital sign measurements, blood oxygen saturation monitoring, 12-lead ECG, continuous ECG monitoring, and clinical laboratory testing', 'tolerability and pharmacokinetic properties', 'accumulation ratios', 'Blood and urine samples', 'Tolerability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4742875', 'cui_str': 'LC28 compound'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0420200', 'cui_str': 'Continuous ECG monitoring'}, {'cui': 'C4505475', 'cui_str': 'Clinical Laboratory Testings'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",32.0,0.115398,Multiple administrations of LC28-0126 exhibited a dose-proportional pharmacokinetic profile and were well tolerated at a dose range of 3-30 mg.,"[{'ForeName': 'Eunwoo', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Inyoung', 'Initials': 'I', 'LastName': 'Hwang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea; Clinical Trials Center, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jaeseong', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea; Department of Clinical Pharmacology and Toxicology, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Myungwon', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Life Sciences Research and Development, LG Chem Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Soon Ha', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Life Sciences Research and Development, LG Chem Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea. Electronic address: ksyu@snu.ac.kr.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.08.011']
3331,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND


This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS


Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS


Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS


Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
3332,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND


Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS


To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS


A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS


Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION


FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
3333,32987282,Fundamental frequency during cognitive preparation and its impact on therapy outcome for panic disorder with Agoraphobia.,"BACKGROUND


Cognitive preparation plays a crucial role in CBT with exposure for panic disorder and agoraphobia. High emotional arousal while developing the exposure rationale might impair patients' cognitive capacities for processing information about treatment and impede therapeutic outcome.
OBJECTIVE


This study investigates whether patients' vocally encoded emotional arousal, assessed by fundamental frequency (f 0 ), during rationale development is associated with premature treatment dropout, insight into the rationale, and symptom reduction.
METHODS


Patients' (N = 197, mean age 36.1 years, 79.2% female) f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia. Insight was rater assessed. Symptom severity was self- and rater assessed at the beginning and end of therapy.
RESULTS


Higher f 0  mean during rationale development was associated with lower probability of insight and less reduction in avoidance behavior. f 0  was not associated with dropout. Insight was associated with lower probability of dropout and partially mediated the association between f 0  and avoidance reduction.
DISCUSSION


This study highlights the importance of emotional arousal during cognitive preparation for exposure. Therapists should ensure that patients are not too highly aroused while learning about the exposure rationale as an important step in treatment.",2020,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"['panic disorder with Agoraphobia', ""Patients' (N\xa0=\xa0197, mean age 36.1 years, 79.2% female""]",['CBT'],['avoidance behavior'],"[{'cui': 'C0236800', 'cui_str': 'Panic disorder with agoraphobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0479158,f 0  during rationale development was measured based on treatment videos from a randomized controlled trial of CBT for panic disorder and agoraphobia.,"[{'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Wieder', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Differential and Personality Psychology, Dresden University of Technology, Zellescher Weg 17, 01069, Dresden, Germany. Electronic address: gesine.wieder@tu-dresden.de.'}, {'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Fischer', 'Affiliation': 'Institute of Medical Psychology, Heidelberg University Hospital, Bergheimer Strasse 20, 69115, Heidelberg, Germany; Faculty of Behavioural and Cultural Studies, Ruprecht-Karls University Heidelberg, Voßstrasse 2, 69115, Heidelberg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Einsle', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany.'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': 'Department of Psychology and Neuroscience, Davie Hall, CB #3270, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-3270, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Hahlweg', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute for Clinical Psychology and Psychotherapy, Dresden University of Technology, Chemnitzer Strasse 46, 01187, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet, Nussbaumstraße 7, 80336, Munich, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Weusthoff', 'Affiliation': 'Institute for Psychology, Department of Clinical Psychology, Psychotherapy and Diagnostics, Technische Universitaet Braunschweig, Mail address: Schwäbische Str. 7, 10781, Berlin, Germany; Private Psychotherapeutic Practice, Everswinkeler Strasse 4, 48351, Alverskirchen, Germany.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103728']
3334,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
3335,32989366,HPV Vaccination Hesitancy Among Latina Immigrant Mothers Despite Physician Recommendation.,"Purpose


Human papillomavirus (HPV) vaccination uptake continues to be low in the United States. While a recommendation from a health care provider (HCP) has been shown to be associated with vaccine acceptability among parents, little is known about factors associated with hesitancy despite HCP recommendation. We examined factors associated with HPV vaccine hesitancy, despite a physician recommendation, among Latina immigrant mothers of daughters aged 9-12 years.
Methods


As part of a group randomized trial to promote HPV vaccination between 2013 and 2016, we conducted a baseline interviewer-administered survey of mothers to assess sociodemographics, knowledge and perceived risk of cervical cancer/HPV infection, self-efficacy, and intention to vaccinate their unvaccinated daughters. Hesitancy was defined as ""don't know/not sure"" (DK/NS) in response to the question: ""If your daughter's doctor recommended that she gets the HPV vaccine, would you let her get it?""
Results


Of the 317 participants, 35.3% indicated hesitancy to vaccinate their daughters if their physician recommended it. Although a number of variables were associated with HPV vaccine hesitancy in the univariate model, five remained significant in the final multivariable model: daughter's health insurance status; HPV awareness; perceived risk of HPV infection for their daughters; perceived self-risk of cervical cancer; and a self-efficacy score of ability to complete the HPV vaccination series.
Conclusions


A recommendation by a health care provider may be not enough to motivate Latina immigrant mothers to vaccinate their daughters. Further efforts should focus on increasing awareness regarding HPV and cervical cancer, heightening perceived risk of HPV infection among daughters and boosting self-efficacy to get their children vaccinated against HPV.",2020,"While a recommendation from a health care provider (HCP) has been shown to be associated with vaccine acceptability among parents, little is known about factors associated with hesitancy despite HCP recommendation.","['Latina Immigrant Mothers Despite Physician Recommendation', 'Latina immigrant mothers of daughters aged 9-12 years']",['HPV vaccination'],"['self-risk of cervical cancer', 'sociodemographics, knowledge and perceived risk of cervical cancer/HPV infection, self-efficacy, and intention to vaccinate their unvaccinated daughters']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}]",,0.0242227,"While a recommendation from a health care provider (HCP) has been shown to be associated with vaccine acceptability among parents, little is known about factors associated with hesitancy despite HCP recommendation.","[{'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Khodadadi', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'University of Alabama at Birmingham School of Public Health, Birmingham, AL.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Scarinci', 'Affiliation': 'University of Alabama at Birmingham Division of Preventive Medicine, Birmingham, AL.'}]",Ethnicity & disease,['10.18865/ed.30.4.661']
3336,32986939,Motor Function in the Late Phase After Stroke: Stroke Survivors' Perspective.,"OBJECTIVE


To examine the association between observer-assessed functional status and perceived recovery in the late phase after stroke. The study also aimed to determine whether observer-assessed functional improvements as a result of horse-riding therapy (H-RT) are related to enhanced perception of stroke recovery.
METHODS


This is a descriptive correlational study using data derived from a three-armed randomized controlled trial in which 123 individuals were enrolled, among whom 43 received H-RT for 12 weeks. The measures included the Modified Motor Assessment Scale, Berg Balance Scale, Timed Up and Go, timed 10-m walk, and perceived recovery from stroke indicated by item #9 in the Stroke Impact Scale (version 2.0). Spearman rank order correlation (rs) was used in the analyses.
RESULTS


There were moderate to strong positive or negative correlations between all four observer-assessed motor variables and participants' ratings of perceived late-phase stroke recovery at trial entrance, ranging from rs=-0.49 to rs=0.54 (p<0.001). The results of the correlational analyses of variable changes showed that, after the end of the H-RT intervention, both self-selected and fast gait speed improvement were significantly correlated with increments in self-rated stroke recovery (rs=-0.41, p=0.01 and rs=-0.38, p=0.02, respectively).
CONCLUSION


This study provided data supporting the association between individual ratings of self-perceived recovery after stroke and observer-assessed individual motor function. The results further demonstrate that enhancement in perceived stroke recovery after completing the intervention was associated with objectively measured gains in both self-selected and fast gait speed.",2020,The results further demonstrate that enhancement in perceived stroke recovery after completing the intervention was associated with objectively measured gains in both self-selected and fast gait speed.,"['123 individuals were enrolled, among whom 43 received H-RT for 12 weeks']",['horse-riding therapy (H-RT'],"['self-rated stroke recovery', 'stroke recovery', 'self-selected and fast gait speed improvement', 'Modified Motor Assessment Scale, Berg Balance Scale, Timed Up and Go, timed 10-m walk, and perceived recovery from stroke indicated by item #9 in the Stroke Impact Scale', 'Motor Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",123.0,0.0336275,The results further demonstrate that enhancement in perceived stroke recovery after completing the intervention was associated with objectively measured gains in both self-selected and fast gait speed.,"[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Bunketorp-Käll', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Pekna', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Pekny', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Samuelsson', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Blomstrand', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Center for Brain Repair, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}]",Annals of rehabilitation medicine,['10.5535/arm.20060']
3337,32992268,Training with tarantulas: A randomized feasibility and acceptability study using experiential learning to enhance exposure therapy training.,"BACKGROUND


Although exposure is a key evidence-based intervention for anxiety, it is infrequently used in clinical settings. This study employed a novel training strategy, experiential learning, to improve exposure implementation. This study aimed to assess the feasibility and acceptability of experiential training and preliminary training effectiveness.
METHODS


Participants were 28 therapists who were randomized to (a) training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders). Workshops lasted one day and were followed by three months of weekly consultation.
RESULTS


Experiential training was viewed as feasible and acceptable. Participants, including those who were fearful of spiders, had a positive response to the training and reported it to be useful. There was a significant increase in the number of exposures used by therapists receiving experiential training compared to training-as-usual at 1-month follow-up.
CONCLUSIONS


A one-day training resulted in significant improvements in knowledge, attitudes toward exposure, and self-efficacy in using exposure. Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual. Results provide evidence for the feasibility and acceptability of experiential training as a strategy to increase the use of evidence-based interventions.",2020,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,['Participants were 28 therapists who were randomized to (a'],"['training-as-usual or (b) experiential training (training-as-usual plus a one-session treatment for fear of spiders', 'experiential learning to enhance exposure therapy training', 'experiential training']","['knowledge, attitudes toward exposure, and self-efficacy', 'number of exposures']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}]",28.0,0.02074,Preliminary findings suggest that experiential training resulted in greater use of exposure post-training compared to training-as-usual.,"[{'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA. Electronic address: hannah.frank@temple.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Becker-Haimes', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Hall-Mercer Community Mental Health Center, 245 S. 8th St., Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Rifkin', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Ollendick', 'Affiliation': 'Child Study Center, Virginia Polytechnic Institute and State University, 460 Turner St., Suite 207, Blacksburg, VA, 24060, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Hilary E', 'Initials': 'HE', 'LastName': 'Kratz', 'Affiliation': 'Department of Psychology, La Salle University, 1900 W. Olney Ave., Philadelphia, PA, 19141, USA.'}, {'ForeName': 'Rinad S', 'Initials': 'RS', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market Street, 3rd Floor, Philadelphia, PA, 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Drive, Philadelphia, PA, 19104, USA; Penn Implementation Science Center at the Leonard David Institute of Health Economics (PISCE @LDI), 3641 Locust Walk, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1701 N 13th St., Philadelphia, PA, 19122, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102308']
3338,32993607,"Safety and Health through Integrated, Facilitated Teams (SHIFT): stepped-wedge protocol for prospective, mixed-methods evaluation of the Healthy Workplace Participatory Program.","BACKGROUND


Healthcare facilities are notorious for occupational health and safety problems. Multi-level interventions are needed to address interacting exposures and their overlapping origins in work organization features. Worker participation in problem identification and resolution is essential. This study evaluates the CPH-NEW Healthy Workplace Participatory Program (HWPP), a Total Worker Health® protocol to develop effective employee teams for worker safety, health, and wellbeing.
METHODS


Six public sector, unionized healthcare facilities are enrolled, in three pairs, matched by agency. The unit of intervention is a workplace health and safety committee, adapted here to a joint labor-management ""Design Team"" (DT). The DT conducts root cause analyses, prioritizes problems, identifies feasible interventions in light of the constraints and needs of the specific setting, makes business-case presentations to facility leadership, and assists in evaluation. Following a stepped-wedge (cross-over) design, one site in each pair is randomly assigned to ""immediate intervention"" status, receiving the full coached intervention at baseline; in the ""lagged intervention"" site, coaching begins about half-way through the study. Program effectiveness and cost-effectiveness outcomes are assessed at both organizational (e.g., workers' compensation claim and absenteeism rates, perceived management support of safety) and individual levels (e.g., self-rated health, sleep quality, leisure-time exercise). Targeted pre-post analyses will also examine specific outcomes appropriate to the topics selected for intervention. Process evaluation outcomes include fidelity of the HWPP intervention, extent of individual DT member activity, expansion of committee scope to include employee well-being, program obstacles and opportunities in each setting, and sustainability (within the available time frame).
DISCUSSION


This study aims for a quantitative evaluation of the HWPP over a time period long enough to accomplish multiple intervention cycles in each facility. The design seeks to achieve comparable study engagement and data quality between groups. We will also assess whether the HWPP might be further improved to meet the needs of U.S. public sector healthcare institutions. Potential challenges include difficulty in pooling data across study sites if Design Teams select different intervention topics, and follow-up periods too short for change to be observed.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04251429 (retrospectively registered January 29, 2020), protocol version 1.",2020,"This study evaluates the CPH-NEW Healthy Workplace Participatory Program (HWPP), a Total Worker Health® protocol to develop effective employee teams for worker safety, health, and wellbeing.
",['Six public sector'],"['HWPP', 'CPH-NEW Healthy Workplace Participatory Program (HWPP']","['Program effectiveness and cost-effectiveness outcomes', 'fidelity of the HWPP intervention, extent of individual DT member activity, expansion of committee scope to include employee well-being, program obstacles and opportunities in each setting, and sustainability (within the available time frame', ""organizational (e.g., workers' compensation claim and absenteeism rates, perceived management support of safety) and individual levels (e.g., self-rated health, sleep quality, leisure-time exercise""]","[{'cui': 'C0034035', 'cui_str': 'Public Sector'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0054757', 'cui_str': 'Carboxypeptidase H'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0033334', 'cui_str': 'Program Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C0043233', 'cui_str': ""Worker's Compensation""}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0398009,"This study evaluates the CPH-NEW Healthy Workplace Participatory Program (HWPP), a Total Worker Health® protocol to develop effective employee teams for worker safety, health, and wellbeing.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Punnett', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA. Laura_Punnett@uml.edu.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nobrega', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Rice', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gore', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Kurowski', 'Affiliation': 'Center for the Promotion of Health in the New England Workplace (CPH-NEW), Lowell, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-09551-2']
3339,33001564,Efficacy of dental floss with ellipsoidal knots vs conventional dental floss for plaque removal: A split-mouth randomized trial.,"OBJECTIVES


To compare clinical efficacy for plaque removal between dental floss with soft ellipsoidal knots and conventional floss.
MATERIALS AND METHODS


We studied 33 university students (29 females and 4 males, 13 of them undergraduate/postgraduate students of dentistry), including regular and sporadic (less once/wk) users of dental floss, with interproximal spaces ≤1 mm, who used floss with and without knots in a randomized manner following a split-mouth design. The Modified Navy Plaque Index (RMNPI) by Rustogi et al. was applied to determine the total removed plaque (TPI) and that removed in the gingival area (GPI) and interproximal spaces (IPI).
RESULTS


The reduction in GPI was greater with the knotted vs conventional floss in all cases (14.77 ± 12.38; 64.79% vs 17.38 ± 13.66; 57.51%) and especially among no floss users (12.469 ± 10.98; 68.02% vs 15.833 ± 11.88; 58.55%). No statistically significant difference between floss types was found in TPI and IPI (globally or by floss utilization frequency) or in the mean GPI of floss users.
CONCLUSION


Floss with ellipsoidal knots showed similar efficacy to remove plaque in patients with less experience of flossing (but without statistically significant differences) compared with flossing themselves with conventional floss, and it may be an optimal solution for patients starting to use dental floss and for those with a lesser or only sporadic history of floss utilization.",2020,"No statistically significant difference between floss types was found in TPI and IPI (globally or by floss utilization frequency) or in the mean GPI of floss users.
","['We studied 33 university students (29 females and 4 males, 13 of them undergraduate/postgraduate students of dentistry,) including regular and sporadic (less once/week']",['ellipsoidal knots vs conventional dental floss'],"['reduction in GPI', 'TPI and IPI', 'Modified Navy Plaque Index (RMNPI']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205422', 'cui_str': 'Sporadic'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0585347', 'cui_str': 'Single event'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162350', 'cui_str': 'Dental floss'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C1444179', 'cui_str': 'Structure of interdental space'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}]",33.0,0.0512252,"No statistically significant difference between floss types was found in TPI and IPI (globally or by floss utilization frequency) or in the mean GPI of floss users.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Roa López', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Granada University, Granada, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Moreu Burgos', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Granada University, Granada, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Aguilar Salvatierra', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Granada University, Granada, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernández Delgado', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Granada University, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Bravo', 'Affiliation': 'Department of Preventive and Community Dentistry, Faculty of Dentistry, Granada University, Granada, Spain.'}, {'ForeName': 'Maximino', 'Initials': 'M', 'LastName': 'González Jaranay', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Granada University, Granada, Spain.'}]",International journal of dental hygiene,['10.1111/idh.12473']
3340,33007710,Working out the worries: A randomized controlled trial of high intensity interval training in generalized anxiety disorder.,"BACKGROUND


Aerobic exercise (AE) demonstrated an overall medium treatment effect in anxiety disorders (AD) but there is evidence for an ""intensity-response"" relationship. High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters. However, so far no randomised-controlled trial (RCT) investigated the efficacy of HIIT in AD.
METHODS


33 patients with generalized anxiety disorder (GAD) were randomly assigned to 12-day HIIT or a training of lower intensity (LIT). Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC) were assessed at baseline, post-training and 30 days after baseline by using the Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression (Ham-A, Ham-D), the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
RESULTS


Both interventions showed moderate or large effects on all clinical measures. However, effects for HIIT were generally about twice as high as for LIT. PC negatively correlated with GAD severity in the whole sample at baseline but an association of training-induced changes in PC and worrying were exclusively detectable in HIIT.
CONCLUSION


HIIT was highly effective and fast acting in GAD. Therefore, it may complement first-line treatment approaches in this condition.",2020,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","['generalized anxiety disorder', '33 patients with generalized anxiety disorder (GAD']","['Aerobic exercise (AE', 'High intensity interval training (HIIT', 'high intensity interval training', '12-day HIIT or a training of lower intensity (LIT']","['Anxiety, comorbid depression, stress-related bodily symptoms and perceived control over anxiety related stimuli (PC', 'Penn State Worry Questionnaire (PSWQ), the Hamilton Inventories for Anxiety and Depression', 'GAD severity', 'Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C2959752', 'cui_str': 'Penn State worry questionnaire'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",33.0,0.0824276,", the Screening for Somatoform Symptoms-7 (SOMS-7) and the Anxiety Control Questionnaire (ACQ-R).
","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Plag', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jens.plag@charite.de.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schmidt-Hellinger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: paul-juergen.schmidt@charite.de.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Klippstein', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: theresa.klippstein@charite.de.'}, {'ForeName': 'Jennifer L M', 'Initials': 'JLM', 'LastName': 'Mumm', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: jennifer.mumm@charite.de.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wolfarth', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Sports Medicine, Berlin, Germany. Electronic address: bernd.wolfarth@charite.de.'}, {'ForeName': 'Moritz B', 'Initials': 'MB', 'LastName': 'Petzold', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: moritz.petzold@charite.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Berlin, Germany. Electronic address: andreas.stroehle@charite.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102311']
3341,33009192,Postoperative pain therapy with hydromorphone; comparison of patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia: A randomised controlled trial.,"BACKGROUND


The challenge of managing acute postoperative pain is the well tolerated and effective administration of analgesics with a minimum of side effects. The standard therapeutic approach is patient-controlled analgesia (PCA) with systemic opioids. To overcome problems of oscillating opioid concentrations, we studied patient-controlled analgesia by target-controlled infusion (TCI-PCA) as an alternative.
OBJECTIVE


To compare efficacy, safety and side effects of standard PCA with TCI-PCA for postoperative pain therapy with hydromorphone.
DESIGN


Single-blinded, randomised trial.
SETTING


University Hospital, Germany from December 2013 to April 2015.
PARTICIPANTS


Fifty adults undergoing cardiac surgery.
INTERVENTIONS


Postoperative pain therapy on the ICU was managed with intravenous (i.v.) hydromorphone and patients randomised to TCI-PCA with target plasma concentrations between 0.8 and 10 ng ml, or PCA with bolus doses of 0.2 mg. Pain was regularly assessed using the 11-point numerical rating scale (NRS). Blood pressure, heart rate, oxygen saturation and cardiac output were continuously monitored, and adverse events were registered throughout the study.
MAIN OUTCOME MEASURES


NRS pain ratings, hydromorphone doses, haemodynamic effects and side effects.
RESULTS


NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA. The number of bolus doses during PCA was significantly higher than the number of target increases during TCI-PCA (P = 0.006). The number of negative requests was also significantly higher during PCA than during TCI-PCA (P = 0.02). The respiratory rate on the first postoperative morning was 25 ± 6 min during TCI-PCA, compared with 19 ± 4 min during PCA (P = 0.022). Nausea occurred in 30% after TCI-PCA and 24% after PCA (P = 0.46).
CONCLUSION


TCI-PCA was effective and well tolerated in acute postoperative pain management after cardiac surgery. Further studies are needed to evaluate this approach in clinical practice.
TRIAL REGISTRATION


EudraCT Number: 2013-002875-16, and ClinicalTrials.gov Identifier: NCT02035709.",2020,"RESULTS


NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA.","['Fifty adults undergoing cardiac surgery', 'University Hospital, Germany from December 2013 to April 2015']","['Postoperative pain therapy', 'TCI-PCA', 'hydromorphone', 'standard PCA with TCI-PCA', 'patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia']","['respiratory rate', 'NRS pain ratings, hydromorphone doses, haemodynamic effects and side effects', 'NRS pain ratings, total doses of hydromorphone and haemodynamic data', 'number of bolus doses during PCA', 'Pain', 'number of negative requests', '11-point numerical rating scale (NRS', 'Nausea', 'Blood pressure, heart rate, oxygen saturation and cardiac output']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",50.0,0.213414,"RESULTS


NRS pain ratings, total doses of hydromorphone and haemodynamic data did not differ significantly between TCI-PCA and PCA.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wehrfritz', 'Affiliation': 'From the Department of Anaesthesiology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany (AW, HI, TF, MK, SK, AW, JS, CJ).'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ihmsen', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Fuchte', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kremer', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weiß', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schüttler', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jeleazcov', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001360']
3342,33029804,Single- or double-layer uterine closure techniques following cesarean: A randomized trial.,"INTRODUCTION


Cesarean deliveries are commonly performed throughout the world. Although the uterine closure technique following this procedure may influence how the uterine scar heals, there is insufficient evidence for choosing the appropriate technique and so preventing long-term negative consequences. This prospective, randomized study examined the effects of single- and double-layer uterine closure techniques on uterine scar healing following cesarean delivery.
MATERIAL AND METHODS


This study assessed a total of 282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies. None had previously undergone uterine surgeries. These participants completed their first cesarean deliveries at the time of study and were randomized into the following two treatment groups: single-layer closure with locking and double-layer closure with locking in the first layer, but not in the second layer (NCT03629028). However, the decidua was not included for treatment in either group. Participants were evaluated at 6-9 months after cesarean section by saline infusion sonohysterography to assess cesarean delivery scar defects. These procedures were conducted by experienced sonographers who were not aware of the uterine closure technique.
RESULTS


Of the 225 final participants, 109 received the single-layer closure technique, whereas 116 received the double-layer technique. The niche rates were 37% (n = 40) for the single-layer group and 45.7% (n = 53) for the double-layer group (P = .22, relative risk 1.4, 95% CI = 0.8-4.4).
CONCLUSIONS


The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.",2020,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"['Of the 225 final participants', 'cesarean', '282 women aged 18-45 years who were in gestational weeks 24-41 of singleton pregnancies', 'participants completed their first cesarean deliveries at the time of study']","['single- and double-layer uterine closure techniques', 'Single or double-layer uterine closure techniques', 'single-layer closure with locking and double-layer closure with locking']","['uterine-scar healing', 'niche rates', 'cesarean delivery scar defects']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0243067', 'cui_str': 'defects'}]",282.0,0.192183,The single- and double-layer closure techniques did not produce different impacts on uterine scar niche development.,"[{'ForeName': 'Şafak', 'Initials': 'Ş', 'LastName': 'Yılmaz Baran', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Kalaycı', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Gülşen', 'Initials': 'G', 'LastName': 'Doğan Durdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Yetkinel', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Songül', 'Initials': 'S', 'LastName': 'Alemdaroğlu', 'Affiliation': 'Department of Obstetrics and Gynecology, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Çok', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and IVF Unit, Başkent University Faculty of Medicine, Adana, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Bulgan Kılıçdağ', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and IVF Unit, Başkent University Faculty of Medicine, Adana, Turkey.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.14018']
3343,33034510,Effect of Postablation Monitoring Strategy on Long-Term Outcome for Catheter Ablation of Persistent Atrial Fibrillation: A Substudy of the STAR AF II Trial.,,2020,,['Catheter Ablation of Persistent Atrial Fibrillation'],['Post-Ablation Monitoring Strategy'],[],"[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",[],,0.0265829,,"[{'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Conti', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Canada (S.C., A.V.).'}, {'ForeName': 'Chen-Yang', 'Initials': 'CY', 'LastName': 'Jiang', 'Affiliation': 'Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China (C.-y.J.).'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': 'Department of Cardiology, Oxford University Hospitals, John Radcliffe Hospital, United Kingdom (T.R.B.).'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Haukeland University Hospital, University of Bergen, Norway (J.C.).'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Deisenhofer', 'Affiliation': 'Deutsches Herzzentrum München, Munich, Germany (I.D.).'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mantovan', 'Affiliation': ""Ospedale S. Maria di Ca' Foncelli, Treviso, Italy (R.M.).""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Canada (L.M.).'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, Canada (C.A.M.).'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin, Germany (W.H.).'}, {'ForeName': 'Rukshen', 'Initials': 'R', 'LastName': 'Weerasooriya', 'Affiliation': 'Department of Cardiology, Hollywood Private Hospital, Nedlands, Western Australia (R.W.).'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Albenque', 'Affiliation': 'Département de Rythmologie, Clinique Pasteur Toulouse, France (J.-P.A.).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nardi', 'Affiliation': 'Pineta Grande Hospital, Castel Volturno, Italy (S.N.).'}, {'ForeName': 'Endrj', 'Initials': 'E', 'LastName': 'Menardi', 'Affiliation': 'Ospedale Santa Croce e Carle, Cuneo, Italy (E.M.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, Canada (P.N.).'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital, Australia (P.S.).'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Canada (S.C., A.V.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008682']
3344,33031956,CITY Health II - using entertainment education and social media to reduce HIV among emerging adults: A protocol paper for the Beat HIVe project.,"BACKGROUND


Despite multiple efforts to reduce HIV rates among African American young adults, a significant racial disparity persists and continues to grow among this population. New approaches are needed to reach this at-risk group and engage them in prevention efforts. The Community Influences Transitions of Youth Health (CITY Health II) study aims to increase HIV preventive behaviors to decrease HIV rates among 18-25 year old African American emerging adults living in resource-poor southern urban communities.
METHODS


CITY Health II is a 5-year HIV prevention study that evaluates the efficacy of a peer-driven entertainment education intervention compared to an attention-control intervention using a cluster randomized trial design. Participants were recruited through respondent-driven sampling (RDS) to participate in a social media intervention. We enlisted eight musicians and groups to help us create an entertaining and educational web-based video series, ""The Beat HIVe"", for study participants to view on smartphones and share with peers on social media. Data collection interviews at baseline, 3-month, and 6-month follow-up assessed socio-demographics, risk and protective behaviors, social networks, and peer norms. Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes.
DISCUSSION


Outcomes will inform ways to engage African American emerging adults through entertainment education and other strategies for increasing optimal sexual health behaviors.
TRIAL REGISTRATION


NCT04320186.",2020,"Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes.
","['Participants were recruited through respondent-driven sampling (RDS) to participate in a social media intervention', '18-25\u202fyear old African American emerging adults living in resource-poor southern urban communities', 'African American young adults', 'CITY Health II']","['attention-control intervention', 'peer-driven entertainment education intervention']","['HIV rates', 'socio-demographics, risk and protective behaviors, social networks, and peer norms']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}]",,0.0463693,"Analyses will determine if participation is associated with improved HIV-related outcomes; examine whether intervention changes are mediated by perceived social norms and outcome expectations; determine whether intervention benefits vary by sociodemographic characteristics related to mediators, intervention outcome, or level of engagement; and examine the relationship between participant dose of intervention and outcomes.
","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Davies', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA. Electronic address: sdavies@uab.edu.'}, {'ForeName': 'Tamika L', 'Initials': 'TL', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Murphy', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Crawford', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Kaiser', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Olivio J', 'Initials': 'OJ', 'LastName': 'Clay', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106167']
3345,33032009,Step-stress vs. staircase fatigue tests to evaluate the effect of intaglio adjustment on the fatigue behavior of simplified lithium disilicate glass-ceramic restorations.,"The aim of the study was to compare the outcomes for the fatigue mechanical behavior of bonded simplified lithium disilicate restorations, with and without an internal adjustment by grinding with diamond bur in running two fatigue tests: Staircase and Step-stress testing approaches. Ceramic discs (IPS e.max CAD) were prepared (Ø = 10 mm; thickness = 1.0 mm), submitted to an in-lab simulation of CAD/CAM milling (#60 SiC paper) and allocated into 2 groups according to the internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR). Adhesive cementation (Multilink N) was performed onto epoxy resin discs (Ø = 10 mm; thickness = 2 mm) after ceramic/epoxy surface treatments. The cemented assemblies of each group were randomly assigned into 2 subgroups considering two fatigue tests (n = 15): Staircase - SC (250,000 cycles; 20 Hz), or Step-stress - SS (10,000 cycles per step; 20 Hz). Roughness, topographic and fractographic analyses were additionally performed. Statistical analyses were carried out using the Dixon and Mood method for Staircase data, and Kaplan-Meier and Mantel-Cox (log-rank) tests for Step-stress data. Ceramic restorations having its intaglio surface ground (GR group: SC test = 306.67 N; SS test = 646.67 N) presented lower fatigue failure load (FFL) values than the CTRL group (SC test = 879.28 N; SS test = 1090.00 N), regardless of the fatigue testing approach. The percentage of mean FFL decrease comparing the CTRL to GR group was higher for SC (65.1%) than the SS (40.7%) approach. However, a different total number of cycles was applied for each method. Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior. Therefore, both methods can be applied for similar evaluations (fatigue testing for ceramic restorations).",2020,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,[],"['Staircase - SC (250,000 cycles; 20\xa0Hz), or Step-stress - SS', 'Adhesive cementation (Multilink N', 'internal adjustment by grinding of the cementation surface: no adjustment (CTRL); or grinding with a coarse diamond bur (GR', 'Ceramic discs (IPS e.max CAD']","['percentage of mean FFL decrease', 'Roughness, topographic and fractographic analyses', 'fatigue failure load (FFL) values']",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0007656', 'cui_str': 'Cementation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0205194', 'cui_str': 'Coarse'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0283014,Both fatigue tests were able to detect the negative effect of internal adjustments of lithium disilicate glass-ceramic simplified restorations on their mechanical behavior.,"[{'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}, {'ForeName': 'Thaís Camponogara', 'Initials': 'TC', 'LastName': 'Bohrer', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: thaiscbohrer@hotmail.com.'}, {'ForeName': 'Patrícia Eliana', 'Initials': 'PE', 'LastName': 'Fontana', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: patricia_fontana_@hotmail.com.'}, {'ForeName': 'Tatiana Tambara', 'Initials': 'TT', 'LastName': 'Fröhlich', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: frohlichtatiana@gmail.com.'}, {'ForeName': 'Liliana Gressler', 'Initials': 'LG', 'LastName': 'May', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: liligmay@gmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.104091']
3346,33032234,Periodontal treatment and vascular inflammation in patients with advanced peripheral arterial disease: A randomized controlled trial.,"BACKGROUND AND AIMS


Observational studies support an association between periodontitis and cardiovascular diseases. The study objective was to assess vascular inflammation after periodontal treatment in patients with peripheral arterial disease.
METHODS


Ninety patients with peripheral arterial disease (PAD) and severe periodontitis were enrolled in a randomized, controlled trial. Thirty patients underwent non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group). The remaining thirty patients did not receive periodontal therapy (CG, control group). The primary outcome of this treatment was a reduction in vascular inflammation three months after periodontal treatment as determined by  18 F-FDG PET/CT values. Secondary outcomes were changes in the inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events.
RESULTS


After three months of treatment, a significant improvement in periodontal health was observed in the treatment groups. However, no difference in the primary outcome in the aorta was observed in the three study groups (median target to background ratio follow-up/baseline, PT1 1.00; 95% CI 0.97-1.10, PT2 1.00; 95% CI 0.98-1.1, CG 1.1; 95% CI 0.99-1.1, p = 0.75). No significant differences were detected in most diseased segments and active segments. In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries. No differences with regard to relative changes in vascular biomarkers were noted, and no serious cardiovascular adverse events occurred.
CONCLUSIONS


Periodontal treatment was effective and safe but did not reduce vascular inflammation in patients with PAD.",2020,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","['Ninety patients with peripheral arterial disease (PAD) and severe periodontitis', 'patients with peripheral arterial disease', 'patients with PAD', 'patients with advanced peripheral arterial disease', 'Thirty patients underwent']","['non-surgical periodontal therapy and received additional systemic antibiotics (PT1 group), while 30 patients received the same therapy without antibiotics (PT2 group']","['vascular inflammation', 'periodontal health', 'serious cardiovascular adverse events', 'vascular biomarkers', 'reduction in vascular inflammation', 'inflamed periodontal surface area (PISA) and other periodontal parameters, changes in vascular biomarkers, and adverse cardiovascular events']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332392', 'cui_str': 'pT2 category'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",30.0,0.258351,"In addition, no differences were observed in  18 F-FDG uptake in the carotid, iliac, femoral, and popliteal arteries.","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Seinost', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria. Electronic address: gerald.seinost@medunigraz.at.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Horina', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Arefnia', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Kulnik', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kerschbaumer', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Quehenberger', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Muster', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Gütl', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Sieglinde', 'Initials': 'S', 'LastName': 'Zelzer', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gasser', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Mangge', 'Affiliation': 'Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.'}, {'ForeName': 'Reingard', 'Initials': 'R', 'LastName': 'Aigner', 'Affiliation': 'Division of Nuclear Medicine Radiology, Department of Radiology, Medical University of Graz, Austria.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Wimmer', 'Affiliation': 'Division of Operative Dentistry, Periodontology and Prosthodontics, Department of Dental Medicine and Oral Health, Medical University of Graz, Austria.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.09.019']
3347,33032256,Effects of familial Mediterranean fever on the middle ear.,"OBJECTIVE


To evaluate middle and inner ear function and hearing status of children with familial Mediterranean fever (FMF).
METHODS


We assigned 56 patients with FMF to the study group and 52 healthy volunteers to the control group. The mean age of patients in the study and control groups were 10.10 ± 3.70 and 9.77 ± 3.74 years, respectively. Physical examination and hearing evaluation were performed in both groups. The audiological test battery included 226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment.
RESULTS


The groups were similar in age and sex ratio (p > 0.05 for both comparisons). Pure tone audiogram and distortion product otoacoustic emission results were also similar for both groups (p > 0.05). The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram. The contralateral acoustic stapedial reflex thresholds were significantly higher in the familial Mediterranean fever group (p < 0.05 for all comparisons). The ambient and peak pressure absorbance values of wide-band tympanometry were significantly lower at 2000 Hz and significantly higher at 4000 Hz in the familial Mediterranean fever group (p < 0.05 for both comparisons). The severity and duration of disease adversely affected the absorbance values of wide-band tympanometry at 2000 and 4000 Hz (p < 0.05).
CONCLUSION


To our knowledge, this is the first study to demonstrate the adverse subclinical effects of familial Mediterranean fever on the middle ear. We recommend that children diagnosed with FMF should be closely monitored for future clinical middle ear pathologies.",2020,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"['56 patients with FMF to the study group and 52 healthy volunteers to the control group', 'familial Mediterranean fever on the middle ear', 'children with familial Mediterranean fever (FMF', 'children diagnosed with FMF']",[],"['contralateral acoustic stapedial reflex thresholds', 'ambient and peak pressure absorbance values of wide-band tympanometry', '226-Hz tympanometry, pure tone audiometric evaluation, acoustic stapedial reflex measurements, distortion product otoacoustic emission recording, and wide-band tympanometry assessment', 'absorbance values of wide-band tympanometry', 'Physical examination and hearing evaluation', 'ipsilateral acoustic stapedial reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031069', 'cui_str': 'Familial Mediterranean fever'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",[],"[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0428765', 'cui_str': 'Stapedial reflex threshold'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C1268822', 'cui_str': 'Optical density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0085853', 'cui_str': 'Tympanometry testing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034934', 'cui_str': 'Stapedial reflex'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0162525', 'cui_str': 'Spontaneous Otoacoustic Emissions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]",56.0,0.0334702,The ipsilateral acoustic stapedial reflex were present in both of the groups and all participants had Type A tympanogram.,"[{'ForeName': 'Asli Cakir', 'Initials': 'AC', 'LastName': 'Cetin', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: asli.cakir@deu.edu.tr.'}, {'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Acari', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ceyhun.acari@deu.edu.tr.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Evin', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: handeevin1@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Omer Ikiz', 'Affiliation': 'Department of Otorhinolaryngology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: ahmet.ikiz@deu.edu.tr.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Kirkim', 'Affiliation': 'Department of Otorhinolaryngology, Unit of Speech, Hearing & Balance, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: gunay.kirkim@deu.edu.tr.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Unsal', 'Affiliation': 'Department of Pediatrics, Section of Immunology and Rheumatology, Dokuz Eylul University, School of Medicine, Izmir, Turkey. Electronic address: erbil.unsal@deu.edu.tr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110417']
3348,33034651,"Evaluation of a Novel Decision Guide ""Go to the Hospital or Stay Here?"" for Nursing Home Residents and Families: A Randomized Trial.","Initiatives to reduce potentially preventable hospitalizations of nursing home residents have focused on staff response to changes in condition and advance care planning. Yet, resident and family insistence on transfer has been one of the most intractable sources of these hospitalizations, although not the target of active intervention until now. Consented residents and family members in the intervention group received a newly developed decision aid entitled, ""Go to the Hospital or Stay Here?,"" providing information on the risks and benefits of transfer versus remaining in the nursing home. This person-centered decision aid was developed from the results of 271 interviews of residents, families, and providers to identify what they wanted to know and any misunderstandings surrounding the transfer process. Engaging residents in the decision respects their right to participate and provides the information they need to make a deliberative decision. The intervention group showed a gain in knowledge and reduction in decisional conflict but reported decreased decisional preparation. There was no decrease in transfers compared to the control group. Evaluation of the decision guide by residents and families was positive.
TARGETS


Nursing home residents and their family members.
INTERVENTION


To provide information regarding the decision to stay in the nursing home or transfer to acute care due to a change in condition.
MECHANISMS OF ACTION


Decision aid ""Go the ""Hospital or Stay Here?"" to impart knowledge regarding the decision to remain in the nursing home or transfer to acute care.
OUTCOMES


Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation. No reduction in transfers was found. Residents and families rated the Guide as very helpful. [Research in Gerontological Nursing, 13(6), 309-319.].",2020,"OUTCOMES


Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation.","['Nursing Home Residents and Families', 'Nursing home residents and their family members']","['newly developed decision aid entitled, ""Go to the Hospital or Stay Here?,"" providing information on the risks and benefits of transfer versus remaining in the nursing home']","['decisional preparation', 'transfers', 'gain in knowledge and reduction in decisional conflict', ""residents' and family members' knowledge and decrease decisional conflict""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0154065,"OUTCOMES


Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation.","[{'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Tappen', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Worch', 'Affiliation': ''}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hain', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20201002-01']
3349,33036701,"Effect of long-term omega-3 supplementation and a lifestyle multidomain intervention on intrinsic capacity among community-dwelling older adults: Secondary analysis of a randomized, placebo-controlled trial (MAPT study).","OBJECTIVES


To investigate the effect of omega-3 (ω-3) polyunsaturated fatty acid supplementation and a multidomain intervention (MI) (physical activity counselling, cognitive training and nutritional advice) among community-dwelling older adults on levels of intrinsic capacity (IC), a construct recently proposed by the World Health Organization.
STUDY DESIGN


Secondary analysis from the factorial-design 3-year Multidomain Alzheimer Preventive Trial (MAPT) with 1445 subjects (64.2 % female, mean age 75.3 years, SD = 4.4) randomized to one group of MI plus ω-3 (800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid/day); MI plus placebo; ω-3 supplementation alone; or placebo alone. Data collection was held between 2008 and 2014.
MAIN OUTCOME MEASURES


IC domains were examined with the Geriatric Depression Scale (psychological); Short Physical Performance Battery (mobility); Z-score combining four tests (cognitive function); and handgrip strength (vitality). All domains were combined into a composite IC Z-score.
RESULTS


After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3: -0.16, 95 %CI: -0.22 to -0.10; MI alone: -0.13, 95 %CI: -0.19 to -0.07; ω-3 alone: -0.19, 95 %CI: -0.25 to -0.10; placebo: -0.20, 95 %CI: -0.26 to -0.14; all p < 0.0001). There were no significant differences between groups. In a sensitivity analysis with categorical time, significant within-group declines were first identified at 24 months for all groups.
CONCLUSIONS


This trial designed to improve cognitive function was unable to find effects of the intervention on the composite IC Z-score. Further investigations are needed, especially trials providing stronger interventions (such as exercise training and a controlled diet) and also embracing the sensorial domain of IC.",2020,"After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3:","['Secondary analysis from the factorial-design 3-year Multidomain Alzheimer Preventive Trial (MAPT) with 1445 subjects (64.2 % female, mean age 75.3 years, SD = 4.4', 'community-dwelling older adults']","['placebo', 'MI plus ω-3 (800 mg docosahexaenoic acid and 225 mg eicosapentaenoic acid/day); MI plus placebo; ω-3 supplementation alone; or placebo alone', 'long-term omega-3 supplementation and a lifestyle multidomain intervention', 'omega-3 (ω-3) polyunsaturated fatty acid supplementation and a multidomain intervention (MI) (physical activity counselling, cognitive training and nutritional advice']","['intrinsic capacity', 'cognitive function', 'IC Z-score', 'Short Physical Performance Battery (mobility); Z-score combining four tests (cognitive function); and handgrip strength (vitality', 'Geriatric Depression Scale (psychological', 'intrinsic capacity (IC']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.119789,"After 3 years, IC Z-score decreased among all groups when time was considered continuous (MI plus ω-3:","[{'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Giudici', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France. Electronic address: kellygiudici@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beard', 'Affiliation': 'University of Sydney, Sydney, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cantet', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Araujo de Carvalho', 'Affiliation': 'Department of Ageing and Life Course, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France; UPS/Inserm UMR1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Maturitas,['10.1016/j.maturitas.2020.06.012']
3350,32990234,[Construction and validation of a nomogram for predicting the risk of portal vein thrombosis after splenectomy in patients with hepatitis B cirrhosis].,"OBJECTIVE


To construct and validate an individualized nomogram to predict the probability of occurrence of portal vein thrombosis (PVT) after splenectomy in patients with hepatitis B cirrhosis.
METHODS


We retrospectively collected the clinical data from 180 patients with hepatitis B cirrhosis undergoing splenectomy with postoperative anticoagulation therapy during the period from January, 2014 to January, 2020 in our hospital. The patients were randomized into modeling group ( n = 120) and validation group ( n =60), and the former group was further divided into PVT group ( n =49) and non-PVT group ( n =71) according to the occurrence of PVT occurred within 1 month after splenectomy. The independent risk factors of PVT after splenectomy were screened in the modeling group using univariate and multivariate binary logistic regression analyses and were used for construction of the nomogram prediction model. The area under the receiver-operating characteristic (AUROC) curve (C-index), GiViTI calibration belt and Hosmer-Lemeshow test, and the DCA curve were used to estimate the discrimination power, calibration and clinical efficiency of the prediction model in both the model construction group and validation group.
RESULTS


Univariate and multivariate logistic regression analyses showed that a history of hemorrhage, portal vein diameter, spleen vein diameter, spleen volume, varicose, postoperative platelet change, and postoperative D-dimer differed significantly between PVT group and non-PVT group ( P  < 0.05), and portal vein diameter, spleen vein diameter, and postoperative platelet change were independent risk factors of PVT after splenectomy ( P  < 0.05). The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group. The 80% and 95% CI  region of GiViTI calibration belt did not cover the 45-degree diagonal bisector line ( P =0.965 and 0.632, respectively), and the P-values of the Hosmer-Lemeshow test were 0.624 and 0.911, respectively, suggesting a high reliability of the predicted probability by the model. DCA curve analysis showed a threshold probability of 30.5%, with a net benefit of 30% in the modeling group and 34% in the validation group, indicating a good clinical efficiency of the model.
CONCLUSIONS


The model for predicting the risk of PVT after splenectomy in patients with hepatitis B cirrhosis can help in early identification of patients having high risks of PVT.",2020,The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group.,"['180 patients with hepatitis B cirrhosis undergoing splenectomy with postoperative anticoagulation therapy during the period from January, 2014 to January, 2020 in our hospital', 'patients with hepatitis B cirrhosis']",[],"['history of hemorrhage, portal vein diameter, spleen vein diameter, spleen volume, varicose, postoperative platelet change, and postoperative D-dimer', 'portal vein diameter, spleen vein diameter, and postoperative platelet change', 'portal vein thrombosis', 'portal vein thrombosis (PVT']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439652', 'cui_str': 'Varicose'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235603', 'cui_str': 'Platelet changes'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis'}]",180.0,0.0292147,The prediction model had a good discrimination power with AUROC (C-index) of 0.880 (95%  CI : 0.818-0.942) in the modeling group and 0.873 (95%  CI : 0.785-0.960) in the validation group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Tu', 'Affiliation': 'Department of Hepatobiliary Surgery, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China.'}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.09.07']
3351,32986466,Changes in Tendon Elongation and Muscle Atrophy Over Time After Achilles Tendon Rupture Repair: A Prospective Cohort Study on the Effects of Early Functional Mobilization.,"BACKGROUND


Early functional mobilization (EFM) may improve patient outcome after Achilles tendon rupture (ATR). However, whether EFM affects patient outcome via changes in tendon elongation, thickening, or calf muscle atrophy is unknown.
PURPOSE


To analyze differences in tendon and muscle morphology recovery over time between groups treated with EFM or standard treatment after ATR repair.
STUDY DESIGN


Cohort study; Level of evidence, 2.
METHODS


This prospective cohort study included 86 patients (20 women) with ATR repair who had a mean (SD) age of 39.3 (8.2) years and were part of a larger prospective randomized controlled trial. Patients were postoperatively randomized to immediate postoperative weightbearing and ankle motion (EFM group) or to immobilization in a below-knee plaster cast for 2 weeks (control group). Patient-reported and functional outcomes were assessed at 6 and 12 months with the Achilles Tendon Total Rupture Score and the heel-rise test for endurance. At 2 and 6 weeks and 6 and 12 months postoperatively, B-mode ultrasound imaging was performed to assess the length and cross-sectional area (CSA) of the Achilles tendon, the gastrocnemius CSA, as well as the thickness of soleus.
RESULTS


The Achilles Tendon Total Rupture Score for the EFM and control groups were 65.8 (18.7) and 56.8 (20.1;  P  = .045), respectively, at 6 months and 79.6 (15.8) and 78.9 (17.2;  P  = .87), respectively, at 12 months. At 2 weeks, tendon elongation was significantly more pronounced in the EFM group as compared with the control group (mean side-to-side difference, 1.88 cm vs 0.71 cm;  P  = .005). Subsequently, tendon elongation increased in the control group while it decreased in the EFM group so that at 6 and 12 months no significant differences between groups were found. Mean Achilles tendon elongation at 1 year was 1.73 (1.07) cm for the EFM group (n = 55) and 1.67 (0.92) cm for the control group (n = 27), with a mean difference of 0.06 cm (95% CI, 0.54 to -0.42;  P  = .80). Achilles tendon CSA and calf muscle atrophy displayed no significant differences between the groups; however, significant changes were demonstrated over time ( P  ≤ .001) in both groups.
CONCLUSION


EFM results in more Achilles tendon elongation at early healing, but this difference subsides over time. EFM does not seem to affect patient outcome via changes in tendon elongation, thickening, or calf muscle atrophy.
REGISTRATION


NCT02318472 (ClinicalTrials.gov identifier).",2020,"Achilles tendon CSA and calf muscle atrophy displayed no significant differences between the groups; however, significant changes were demonstrated over time ( P  ≤ .001) in both groups.
","['or standard treatment after ATR repair', 'After Achilles Tendon Rupture Repair', '86 patients (20 women) with ATR repair who had a mean (SD) age of 39.3 (8.2) years']","['Early functional mobilization (EFM', 'EFM', 'Early Functional Mobilization', 'immediate postoperative weightbearing and ankle motion (EFM group) or to immobilization in a below-knee plaster cast']","['Tendon Elongation and Muscle Atrophy', 'Achilles Tendon Total Rupture Score', 'tendon elongation', 'Mean Achilles tendon elongation', 'Achilles Tendon Total Rupture Score and the heel-rise test for endurance', 'tendon elongation, thickening, or calf muscle atrophy', 'Achilles tendon elongation at early healing', 'Achilles tendon CSA and calf muscle atrophy']","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1318107', 'cui_str': 'Load-Bearing'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0588415', 'cui_str': 'Below knee plaster cast'}]","[{'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",86.0,0.102292,"Achilles tendon CSA and calf muscle atrophy displayed no significant differences between the groups; however, significant changes were demonstrated over time ( P  ≤ .001) in both groups.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Aufwerber', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Edman', 'Affiliation': 'R&D, Norrtälje Hospital, Tiohundra AB, Norrtälje, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Grävare Silbernagel', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Ackermann', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}]",The American journal of sports medicine,['10.1177/0363546520956677']
3352,32988625,[Comparison of palonosetron-dexamethasone and ondansetron-dexamethasone for prevention of postoperative nausea and vomiting in middle ear surgery: a randomized clinical trial].,"BACKGROUND


Postoperative nausea and vomiting is the second most common complaint in the postoperative period after pain. The incidence of postoperative nausea and vomiting was 60-80% in middle ear surgeries in the absence of antiemetic prophylaxis. Because of this high incidence of postoperative nausea and vomiting, we aimed to assess the effect of palonosetron-dexamethasone and ondansetron-dexamethasone combination for the prevention of postoperative nausea and vomiting in patients of middle ear surgery.
METHODS


Sixty-four patients, scheduled for middle ear surgery, were randomized into two groups to receive the palonosetron-dexamethasone and ondansetron-dexamethasone combination intravenously before induction of anesthesia. Anesthesia technique was standardized in all patients. Postoperatively, the incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score were recorded.
RESULTS


Demographics were similar in the study groups. The incidence difference of nausea was statistically significant between groups O and P at a time interval of 2-6hours only (p=0.026). The incidence and severity of vomiting were not statistically significant between groups O and P during the whole study period. The overall incidence of postoperative nausea and vomiting (0-24hours postoperatively) was 37.5% in group O and 9.4% in group P (p=0.016). Absolute risk reduction with palonosetron-dexamethasone was 28%, the relative risk reduction was 75%, and the number-needed-to-treat was 4. The patient's satisfaction score was higher in group P than group O (p=0.016). The frequency of rescue medication was more common in group O than in group P patients (p=0.026).
CONCLUSION


The combination of palonosetron-dexamethasone is superior to ondansetron-dexamethasone for the prevention of postoperative nausea and vomiting after middle ear surgeries.",2020,"The frequency of rescue medication was more common in group O than in group P patients (p=0.026).
","['after middle ear surgeries', 'patients of middle ear surgery', 'middle ear surgery', 'Sixty-four patients, scheduled for middle ear surgery']","['palonosetron-dexamethasone', 'palonosetron-dexamethasone and ondansetron-dexamethasone combination', 'ondansetron-dexamethasone', 'palonosetron-dexamethasone and ondansetron-dexamethasone']","[""patient's satisfaction score"", 'postoperative nausea and vomiting', 'incidence and severity of vomiting', 'nausea', 'incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score', 'frequency of rescue medication', 'overall incidence of postoperative nausea and vomiting', 'relative risk reduction']","[{'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}]","[{'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.247825,"The frequency of rescue medication was more common in group O than in group P patients (p=0.026).
","[{'ForeName': 'Vinit Kumar', 'Initials': 'VK', 'LastName': 'Srivastava', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia. Electronic address: drvinit75@gmail.com.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'All India Institute of Medical Sciences, Department of Anesthesiology, Rishikesh, Uttarakhand, Índia.'}, {'ForeName': 'Sweta Anil', 'Initials': 'SA', 'LastName': 'Deshmukh', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Shree', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Anesthesiology, Chhattisgarh, Índia.'}, {'ForeName': 'Partha Pratim', 'Initials': 'PP', 'LastName': 'Misra', 'Affiliation': 'Apollo Hospitals Bilaspur, Department of Ear Nose Throat Surgery, Chhattisgarh, Índia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.016']
3353,32991337,Improved Viral Suppression With Streamlined Care in the SEARCH Study.,"BACKGROUND


HIV differentiated service delivery (DSD) models are scaling up in resource-limited settings for stable patients; less is known about DSD outcomes for patients with viremia. We evaluated the effect on viral suppression (VS) of a streamlined care DSD model implemented in the SEARCH randomized universal test and treat trial in rural Uganda and Kenya (NCT:01864603).
METHODS


We included HIV-infected adults at baseline (2013) who were country guideline antiretroviral therapy (ART) eligible (prior ART experience or CD4 ≤ 350) with ≥1 HIV clinic visit between 2013 and 2017 in SEARCH communities randomized to intervention (N = 16) or control (N = 16). We assessed the effect of streamlined care in intervention community clinics (patient-centered care, increased appointment spacing, improved clinic access, reminders, and tracking) on VS at 3 years. Analysis was stratified by the baseline care status: ART-experienced with viremia, ART-naïve with CD4 ≤ 350, or ART-experienced with VS.
RESULTS


Among 6190 ART-eligible persons in care, year 3 VS was 90% in intervention and 87% in control arms (RR 1.03, 95% CI: 1.01 to 1.06). Among ART-experienced persons with baseline viremia, streamlined care was associated with higher VS (67% vs 47%, RR 1.41, 95% CI: 1.05 to 1.91). Among ART-naïve persons, VS was not significantly higher with streamlined care (83% vs 79%, RR 1.05, 95% CI: 0.95 to 1.16). Among ART-experienced persons with baseline VS, nearly all remained virally suppressed in both arms (97% vs 95%, RR 1.01, 95% CI: 1.00 to 1.03).
CONCLUSIONS


Streamlined care was associated with higher viral suppression among ART-experienced patients with viremia in this randomized evaluation of ART-eligible patients who were in care after universal HIV testing.",2020,"Among ART-naïve persons, VS was not significantly higher with streamlined care (83% vs 79%, RR 1.05, 95%CI 0.95 -1.16).","['rural Uganda and Kenya (NCT:01864603', 'HIV-infected adults at baseline (2013) who were country guideline antiretroviral therapy (ART) eligible (prior ART experience or CD4≤350) with ≥1 HIV clinic visit between 2013-2017 in SEARCH communities randomized to intervention (N=16) or control (N=16', 'patients with viremia']",[],"['Viral Suppression', 'viral suppression']","[{'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]",[],"[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.250973,"Among ART-naïve persons, VS was not significantly higher with streamlined care (83% vs 79%, RR 1.05, 95%CI 0.95 -1.16).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Hickey', 'Affiliation': 'Division of HIV, ID, and Global Medicine, Department of Medicine, UCSF, San Francisco, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Disease Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Fredrick J', 'Initials': 'FJ', 'LastName': 'Opel', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Asiphas', 'Initials': 'A', 'LastName': 'Owaraganise', 'Affiliation': 'Infectious Disease Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'School of Public Health and Health Sciences, University of Massachusetts Amherst, Amherst, MA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'Division of HIV, ID, and Global Medicine, Department of Medicine, UCSF, San Francisco, CA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Division of HIV, ID, and Global Medicine, Department of Medicine, UCSF, San Francisco, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Division of HIV, ID, and Global Medicine, Department of Medicine, UCSF, San Francisco, CA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Camlin', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, UCSF, San Francisco, CA.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, UCSF, San Francisco, CA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, UCSF, San Francisco, CA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Disease Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, CA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Division of HIV, ID, and Global Medicine, Department of Medicine, UCSF, San Francisco, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002508']
3354,32997156,Comparison of different bone graft with arthroscopy-assisted arthrodesis for the treatment of traumatic arthritis of the subtalar joint.,"AIM OF THE STUDY


To compare the clinical outcomes of traumatic arthritis of the subtalar joint treated by arthroscopy-assisted arthrodesis with autologous bone graft, allogenous bone graft, artifical bone graft, and no bone graft .
METHODS


Sixty-two patients (64 ft) with traumatic arthritis of subtalar joint were randomly divided into four groups. The cases treated with arthroscopy-assisted arthrodesis were analyzed retrospectively. The mean follow-up time was about 22 months (18-28 months) in each group. Clinical outcomes were assessed by the American Orthopaedic Foot and Ankle Society (AOFAS) score, Visual Analog Scale (VAS), and radiographic examination. The post-operative complications in each group were recorded respectively.
RESULTS


All operations were successful, without incision complications. The subtalar joint obtained full osseous fusion in each group. The average time of osseous fusion was about 12 weeks. There was no significant difference in the fusion time with each group (P = 0.991). The AOFAS and VAS scores in each group were improved significantly in the pre-operative vs post-operative evaluation (all P < 0.01). The average operation time in autologous bone graft group was 74.56 ± 11.45 min which significantly different from that of other groups(P < 0.01).
CONCLUSION


Similar clinical outcomes were achieved among each type of bone graft. Therefore, which types of bone graft or not may be not the most important for arthroscopy-assisted subtalar arthrodesis.",2020,The AOFAS and VAS scores in each group were improved significantly in the pre-operative vs post-operative evaluation (all P < 0.01).,"['traumatic arthritis of the subtalar joint', 'Sixty-two patients (64\xa0ft) with traumatic arthritis of subtalar joint']","['arthroscopy-assisted arthrodesis', 'subtalar joint treated by arthroscopy-assisted arthrodesis with autologous bone graft, allogenous bone graft, artifical bone graft', 'bone graft with arthroscopy-assisted arthrodesis']","['fusion time', 'average time of osseous fusion', 'average operation time', 'mean follow-up time', 'AOFAS and VAS scores', 'post-operative complications', 'American Orthopaedic Foot and Ankle Society (AOFAS) score, Visual Analog Scale (VAS), and radiographic examination']","[{'cui': 'C0152086', 'cui_str': 'Traumatic arthropathy'}, {'cui': 'C0038593', 'cui_str': 'Subtalar joint structure'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0038593', 'cui_str': 'Subtalar joint structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}]","[{'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.039365,The AOFAS and VAS scores in each group were improved significantly in the pre-operative vs post-operative evaluation (all P < 0.01).,"[{'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Department of joint surgery, The Seventh Affiliated Hospital, Sun Yet-sun University, No. 628 Zhenyuan road, Shenzhen, 518107, Guangdong, China. doctorwan@i.smu.edu.cn.'}, {'ForeName': 'Liangle', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Zhujiang Hospital, Southern Medical University, Guangzhou, 510515, Guangdong, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of joint surgery, Tongde hospital of Zhejiang province, Hangzhou, 310002, Zhejiang, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Department of joint surgery, Tongde hospital of Zhejiang province, Hangzhou, 310002, Zhejiang, China.'}, {'ForeName': 'Shuliang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of joint surgery, Tongde hospital of Zhejiang province, Hangzhou, 310002, Zhejiang, China. hztree78@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04834-0']
3355,33003972,Long-Term Outcome of the Randomized DAPA Trial.,"BACKGROUND


The randomized DAPA trial (Defibrillator After Primary Angioplasty) aimed to evaluate the survival benefit of prophylactic implantable cardioverter defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction.
METHODS


A randomized, multicenter, controlled trial compared ICD versus conventional medical therapy in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors: left ventricular ejection fraction <30% within 4 days after ST-segment-elevation myocardial infarction, primary ventricular fibrillation, Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention. ICD was implanted 30 to 60 days after MI. Primary end point was all-cause mortality at 3 years follow-up. The trial prematurely ended after inclusion of 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary end point.
RESULTS


A total of 266 patients, 78.2% males, with a mean age of 60.8±11.3 years, were enrolled. One hundred thirty-one patients were randomized to the ICD arm and 135 patients to the control arm. All-cause mortality was significant lower in the ICD group (5% versus 13%, hazard ratio, 0.37 [95% CI, 0.15-0.95]) after 3 years follow-up. Appropriate ICD therapy occurred in 9 patients at 3 years follow-up (5 within the first 8 months after implantation). After a median long-term follow-up of 9 years (interquartile range, 3-11), total mortality (18% versus 38%; hazard ratio, 0.58 [95% CI, 0.37-0.91]), and cardiac mortality (hazard ratio, 0.52 [95% CI, 0.28-0.99]) was significant lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased ≥10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups.
CONCLUSIONS


In this prematurely terminated and thus underpowered randomized trial, early prophylactic ICD implantation demonstrated lower total and cardiac mortality in patients with high-risk ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. Registration: URL: https://www.trialregister.nl; Unique identifier: Trial NL74 (NTR105).",2020,"All-cause mortality was significant lower in the ICD group (5% vs 13%, HR 0.37; 95% CI 0.15-0.95) after 3 years follow-up.","['high risk primary PCI patients, based on one of the following factors: left ventricular ejection fraction (LVEF) < 30% within 4 days after STEMI, primary ventricular fibrillation, Killip class ≥2 and/or TIMI flow < 3 after PCI', '266 patients (38% of the calculated sample size', 'early selected high-risk patients after primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI', ' A total of 266 patients, 78.2% males, with a mean age of 60.8 ± 11.3 years, were enrolled', '131 patients were randomized to the ICD arm and 135 patients to the control arm']","['Randomized Defibrillator', 'ICD', 'prophylactic ICD implantation', 'conventional medical therapy', 'prophylactic implantable cardioverter defibrillator (ICD) implantation', 'Defibrillator']","['cardiac mortality', 'survival benefit', 'ICD', 'cause mortality', 'LVEF', 'cardiac death', 'total mortality', 'All-cause mortality', 'total and cardiac mortality', 'Additional survival assessment']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",131.0,0.182527,"All-cause mortality was significant lower in the ICD group (5% vs 13%, HR 0.37; 95% CI 0.15-0.95) after 3 years follow-up.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Haanschoten', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Anand R', 'Initials': 'AR', 'LastName': 'Ramdat Misier', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Peter Paul H M', 'Initials': 'PPHM', 'LastName': 'Delnoy', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Jaap Jan J', 'Initials': 'JJJ', 'LastName': 'Smit', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Adiyaman', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Demirel', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Hein J J', 'Initials': 'HJJ', 'LastName': 'Wellens', 'Affiliation': 'Cardiovascular Research Centre Maastricht, the Netherlands (H.J.J.W.).'}, {'ForeName': 'Freek W A', 'Initials': 'FWA', 'LastName': 'Verheugt', 'Affiliation': 'Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands (F.W.A.V.).'}, {'ForeName': 'Jan Paul', 'Initials': 'JP', 'LastName': 'Ottervanger', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008484']
3356,33004654,"Ilioinguinal/Iliohypogastric versus quadratus lumborum nerve blockade for elective open inguinal herniorrhaphy: a prospective, randomized, double-blinded, equivalency trial.","BACKGROUND


Open inguinal herniorrhaphy (OIH) is a commonly performed surgical procedure with expected postoperative pain. Historically, an option for regional analgesia has been an ilioinguinal and iliohypogastric nerve block (IINB). More recently, the transmuscular quadratus lumborum block (QLB) has been used as an analgesic technique for a variety of abdominal and truncal surgical procedures. Given our own institutional experiences with the performance of QLB combined with the body of literature supporting the proximal blockade of the ilioinguinal and iliohypogastric nerves via this approach, we compared the analgesia provided by an IINB to a QLB. We hypothesized that the two blocks would provide equivalent analgesia, as defined by a difference of less than±2 points on the pain scale (0-10 numeric rating scale (NRS)), for patients undergoing OIH.
METHODS


Sixty patients scheduled for elective outpatient OIH under general anesthesia were randomized to preoperatively receive either an IINB or a transmuscular QLB with 0.25% bupivacaine/epinephrine/clonidine for postoperative analgesia. The primary endpoint was movement NRS pain scores at 8 hours. Secondary outcomes included resting NRS pain scores at 8 and 24 hours, movement NRS pain scores at 24 hours, incidence of opioid related side effects (nausea, vomiting, pruritus), time-to-first oral opioid analgesic, and total opioid consumption at 24 hours.
RESULTS


Fifty-nine patients were analyzed per an intention-to-treat approach (one patient was excluded because the surgical procedure was canceled). Movement pain scores at 8 hours were equivalent (IINB 5.10±3.02 vs QLB 5.03±3.01 (mean NRS±SD); two one-sided test mean difference (90% CI), 0.07 (-1.24 to 1.38), p ≤0.01). There were no differences between groups for any of the secondary endpoints.
CONCLUSION


An IINB and a transmuscular QLB are equivalent with regards to their ability to provide postoperative analgesia after OIH.",2020,An IINB and a transmuscular QLB are equivalent with regards to their ability to provide postoperative analgesia after OIH.,"['Fifty-nine patients', 'Sixty patients scheduled for elective outpatient OIH under general anesthesia', 'elective open inguinal herniorrhaphy']","['IINB or a transmuscular QLB with 0.25% bupivacaine/epinephrine/clonidine', 'Ilioinguinal/Iliohypogastric versus quadratus lumborum nerve blockade', 'inguinal herniorrhaphy (OIH']","['movement NRS pain scores', 'Movement pain scores', 'resting NRS pain scores at 8 and 24\u2009hours, movement NRS pain scores at 24\u2009hours, incidence of opioid related side effects (nausea, vomiting, pruritus), time-to-first oral opioid analgesic, and total opioid consumption at 24\u2009hours', 'pain scale']","[{'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0394767', 'cui_str': 'Local anesthetic block of iliohypogastric nerve'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0359953', 'cui_str': 'Bupivacaine- and epinephrine-containing product'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",59.0,0.579521,An IINB and a transmuscular QLB are equivalent with regards to their ability to provide postoperative analgesia after OIH.,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Edwards', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA chedward@wakehealth.edu.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Weller', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Turner', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Sean W', 'Initials': 'SW', 'LastName': 'Dobson', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Jaffe', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'J Wells', 'Initials': 'JW', 'LastName': 'Reynolds', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Daryl S', 'Initials': 'DS', 'LastName': 'Henshaw', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101571']
3357,33010473,Patient navigation among recently hospitalized smokers to promote tobacco treatment: Results from a randomized exploratory pilot study.,"INTRODUCTION


Adding screening for health-related social needs to tobacco treatment interventions initiated during hospitalizations may improve intervention effectiveness among vulnerable populations. Our objective was to examine the effect the acceptability and feasibility of a intervention in which a patient navigator screens for and addresses social needs to increase receipt of smoking cessation medication among recently hospitalized smokers at a safety-net hospital.
METHODS


In a two-group randomized exploratory pilot study, we assigned hospitalized smokers to either the Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC + Patient Navigation (up to 10 h of navigation over a 3-month period, in which a navigator screens for and addresses health-related social needs). We assessed socio-demographics, smoking-related variables, and process data.
RESULTS


Of 171 individuals screened, 44 (26%) were enrolled. Participants (mean age = 54.9 years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day. 20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group. 11 participants (47.8%) in the ETC + Patient Navigation group received the minimum intervention dose (completion of the social needs screener and at least one counseling session). Barriers to navigation were participants' medical illness and difficulty connecting with participants.
CONCLUSIONS


Although nearly half of hospitalized smokers receiving support from a patient navigator received a prescription for a smoking cessation medication, the percentage did not differ by study arm. Refinement of the protocol to coordinate with hospital-wide tobacco treatment and social needs screening initiatives is needed.",2020,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","['54.9\xa0years, 61.4% non-Hispanic black, 68.2% high school education or less) smoked a mean of 11.4 cigarettes/day', 'Participants (mean age\xa0', '20 participants', 'Of 171 individuals screened, 44 (26%) were enrolled']","['ETC\xa0+\xa0Patient Navigation group', 'minimum intervention dose (completion of the social needs screener and at least one counseling session', 'Enhanced Traditional Control (ETC) group (list of smoking cessation resources) or ETC\xa0+\xa0Patient Navigation (up to 10\xa0h of navigation']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0547043', 'cui_str': 'Up'}]",[],,0.0505863,"20 participants received a prescription for a cessation medication, 42.9% in the ETC group and 47.8% in the ETC + Patient Navigation group.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States. Electronic address: Lmquinti@bu.edu.'}, {'ForeName': 'Hasmeena', 'Initials': 'H', 'LastName': 'Kathuria', 'Affiliation': 'Boston University, School of Medicine, The Pulmonary Center, Boston Medical Center, Section of Pulmonary, Allergy, Sleep & Critical Care Medicine, 72 East Concord St., Boston, MA 02118, United States.'}, {'ForeName': 'Ve', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murillo', 'Affiliation': 'Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Borrelli', 'Affiliation': 'Boston University, Henry M. Goldman School of Dental Medicine, Center for Behavioral Science Research, 560 Harrison Ave., Boston, MA 02118, United States.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Boston University, School of Public Health, 801 Massachusetts Ave., Crosstown CT453, Boston, MA 02118, United States.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Boston University, School of Medicine, Boston Medical Center, Section of General Internal Medicine, 801 Massachusetts Ave., Crosstown 2, Boston, MA 02118, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106659']
3358,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE


To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA


A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN


A historical cohort.
SETTING


Postoperative period.
PATIENTS


Opioid-naive U.S. veterans.
INTERVENTIONS


The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS


The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS


A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS


Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
3359,33010590,Plantar pressure distribution and wearing characteristics of three forefoot offloading shoes in healthy adult subjects.,"Forefoot offloading shoes are used to reduce pressure on specific regions of the foot. Aim of the pressure reduction is to aid healing of the soft and bony tissues and prevent complications by treating foot disorders. A great variety of forefoot offloading shoes are available. In a first step to investigate the appropriate use of these footwear in orthopedic settings, we studied plantar pressure distribution and wearing characteristics of three forefoot offloading shoes namely the Mailand, OrthoWedge and Podalux in a healthy population. Twenty subjects walked in a randomized order wearing three forefoot offloading shoes and a reference shoe for six minutes. The Pedar system was used to measure the pressure in 7 regions. Peak pressure and pressure time integral were analyzed as measures of pressure distribution. Furthermore, wearing characteristics were addressed using a Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes were compared to a reference shoe. The Mailand and OrthoWedge shoes significantly reduced peak pressure with more than 80% under the hallux and more than 45% under MTH1 (p<.001). The Podalux did not show significant peak pressure reduction under the forefoot compared to the reference shoe. Under the lesser toes, the MTH4-5 region and heel region the Podalux shoe showed even a significant increase in peak pressure (p=.001). Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01). In this study the differences between different forefoot offloading shoes was assessed. The Mailand and OrthoWedge shoes gave the best pressure reduction in the forefoot but are less comfortable in use. The Podalux rocker shoe showed opposite results. Next step is a patient study to compare our results in a patient population.",2020,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","['Twenty subjects walked', 'healthy adult subjects']",[],"['Numeric Rating Scale. Pressure distribution and wearing characteristics of the forefoot offloading shoes', 'Plantar pressure distribution and wearing characteristics', 'Peak pressure and pressure time integral', 'peak pressure reduction', 'peak pressure']","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",20.0,0.0330946,"Looking at wearing characteristics, the Podalux and reference shoe scored significantly better than the other two forefoot offloading shoes (p<.01).","[{'ForeName': 'M C H W', 'Initials': 'MCHW', 'LastName': 'Fuchs', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands. Electronic address: thijn.fuchs@catharinaziekenhuis.nl.'}, {'ForeName': 'M M N', 'Initials': 'MMN', 'LastName': 'Hermans', 'Affiliation': 'Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'H J J', 'Initials': 'HJJ', 'LastName': 'Kars', 'Affiliation': 'Fontys Hogeschool Eindhoven, Allied Health Professions, Dominee Theodor Fliednerstraat 2, 5631 BN Eindhoven, The Netherlands.'}, {'ForeName': 'J G E', 'Initials': 'JGE', 'LastName': 'Hendriks', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'van der Steen', 'Affiliation': 'Department of Orthopaedic Surgery, Catharina Hospital Eindhoven, Postbus 1350, 5602 ZA Eindhoven, The Netherlands; Orthopaedic Center Máxima, Máxima Medical Center, Postbus 90052, 5600 PD Eindhoven, The Netherlands.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101744']
3360,33010649,"The effect of a stress ball on stress, vital signs and patient comfort in hemodialysis patients: A randomized controlled trial.","OBJECTIVE


In this study, an investigation was made of the effect of the use of a stress ball, a method of distraction-attracting the attention elsewhere - on stress, vital signs andcomfort levels in hemodialysis patients.
METHODS


This randomized, controlled experimental study, between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey. The study was conducted with 45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment. The experimental group were asked to squeeze a stress ball for approximately 10-15 min throughout eight successive dialysis sessions. The data were obtained with an Individual Description Form, the Distress Thermometer and the Hemodialysis Comfort Scale.
RESULTS


At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05). However, while the stress score of the experimental group decreased significantly, the stress score of the control groups increased (p < 0.05).
CONCLUSION


This study shows that although the use of the stress ball did not affect vital signs and comfort in hemodialysis patients, it had a positive effect on stress.",2020,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","['45 patients (23 experiments, 22 controls) who were receiving hemodialysis treatment', 'hemodialysis patients', 'between July 2019 and September 2019 was carried out in a dialysis unit in the inner regions of Turkey']",[],"['stress score', 'vital signs and comfort levels', 'stress, vital signs and patient comfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1629858', 'cui_str': 'Dialysis unit'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}]",,0.0236922,"At the end of the study, no significant difference was found in the vital signs and comfort levels of the experimental and control groups (p > 0.05).","[{'ForeName': 'Kadriye Sayin', 'Initials': 'KS', 'LastName': 'Kasar', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: kadriyekasar@aksaray.edu.tr.'}, {'ForeName': 'Saadet', 'Initials': 'S', 'LastName': 'Erzincanli', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Aksaray University, Aksaray, Turkey. Electronic address: saadeterzincanli@hotmail.com.'}, {'ForeName': 'Nesat Tolga', 'Initials': 'NT', 'LastName': 'Akbas', 'Affiliation': 'Dialysis Unit, Training and Research Hospital, Aksaray University, Aksaray, Turkey. Electronic address: takbas@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101243']
3361,33016896,Improving motion detection via anodal transcranial direct current stimulation.,"BACKGROUND


To study motion perception, a stimulus consisting of a field of small, moving dots is often used. Generally, some of the dots coherently move in the same direction (signal) while the rest move randomly (noise). A percept of global coherent motion (CM) results when many different local motion signals are combined. CM computation is a complex process that requires the integrity of the middle-temporal area (MT/V5) and there is evidence that increasing the number of dots presented in the stimulus makes such computation more efficient.
OBJECTIVE


In this study, we explored whether anodal direct current stimulation (tDCS) over MT/V5 would increase individual performance in a CM task at a low signal-to-noise ratio (SNR, i.e. low percentage of coherent dots) and with a target consisting of a large number of moving dots (high dot numerosity, e.g. >250 dots) with respect to low dot numerosity (<60 dots), indicating that tDCS favour the integration of local motion signal into a single global percept (global motion).
METHOD


Participants were asked to perform a CM detection task (two-interval forced-choice, 2IFC) while they received anodal, cathodal, or sham stimulation on three different days.
RESULTS


Our findings showed no effect of cathodal tDCS with respect to the sham condition. Instead, anodal tDCS improves performance, but mostly when dot numerosity is high (>400 dots) to promote efficient global motion processing.
CONCLUSIONS


The present study suggests that tDCS may be used under appropriate stimulus conditions (low SNR and high dot numerosity) to boost the global motion processing efficiency, and may be useful to empower clinical protocols to treat visual deficits.",2020,Our findings showed no effect of cathodal tDCS with respect to the sham condition.,"['Participants were asked to perform a CM detection task (two-interval forced-choice, 2IFC) while they received']","['anodal direct current stimulation (tDCS) over MT/V5', 'anodal tDCS', 'tDCS', 'anodal, cathodal, or sham stimulation']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],,0.0409238,Our findings showed no effect of cathodal tDCS with respect to the sham condition.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Battaglini', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Mena', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Casco', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201050']
3362,33011546,"Could ""triple-therapy"" considered as a novel-optimal treatment model for acute bipolar depression? A prospective real-world research in China.","BACKGROUND


Results of researches of bipolar depression treatment are inconsistent and to our knowledge, no study has previously revealed an optimal treatment model for bipolar depression in the real-world through a prospective way.
OBJECTIVE


To find out an optimal treatment model for bipolar depression in the real-world by evaluating the effect of different treatment models: monotherapy, double-therapy and triple-therapy.
DESIGN


and Intervention: This 12 or 16-week, multi-center, real-world clinical study was conducted at 15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up. During the study weeks, all researchers could choose a most proper treatment model freely basing on the evaluation of patient's symptoms and complete the follow-up according to the procedure.
MAIN OUTCOMES AND MEASURES


The primary outcomes were baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects. Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI) from baseline to endpoint, treatment-emergent mania rate and severe adverse events rate were used as secondary outcomes.
RESULTS


During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001). At week 4, mean scores of MARDS in triple-therapy group are statistically significant lower than monotherapy group (P = 0.013) and at the endpoint, mean scores of MARDS in triple-therapy group are statistically significant lower than both double-therapy and monotherapy groups (P = 0.011). The severe adverse events rates are rare in all the 3 groups at week 4 and endpoint, and the rate of dry mouth in triple-therapy group at week 4 is statistically significant lower than the other 2 groups (P = 0.002).
CONCLUSIONS


Triple-therapy is more effective in treating bipolar depression than double-therapy and monotherapy model with a lower risk of developing manic symptoms.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. Identifier: ChiCTR1800019064.",2020,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).",['15 study sites (inpatient or outpatient department) in West China and a total of 573 patients completed the follow-up'],"['monotherapy, double-therapy and triple-therapy']","['severe adverse events rates', 'MARDS, YMRS and CGI', 'mean scores of MARDS', 'rate of dry mouth', 'baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) total score and the constituent ratio of effects', 'mania rate and severe adverse events rate', 'response and response rates', 'Total score change in Young Mania Rating Scale (YMRS) and Clinical Global Impression (CGI', 'mania rates']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0338831', 'cui_str': 'Mania'}]",573.0,0.0263737,"During all study weeks, all the 3 groups showed a statistically significant improvement in MARDS, YMRS and CGI (P＜0.001), but the triple-therapy group showed much more effective in significant response and response rates at endpoint than double-therapy group and monotherapy group (P＜0.001) with lower treatment-emergent mania rates (P = 0.001).","[{'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Psychosomatic Medical Center of Sichuan People's Hospital, China.""}, {'ForeName': 'Ruhan', 'Initials': 'R', 'LastName': 'A', 'Affiliation': 'Sleep Medicine Center of University of Electronic Science and Technology Hospital, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Mental Health Center, West China Hospital of Sichuan University, China. Electronic address: sunxueli2018@126.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.09.017']
3363,33012603,Immunogenicity of seasonal inactivated influenza and inactivated polio vaccines among children in Senegal: Results from a cluster-randomized trial.,"Data on influenza vaccine immunogenicity in children are limited from tropical developing countries. We recently reported significant, moderate effectiveness of a trivalent inactivated influenza vaccine (IIV) in a controlled, cluster-randomized trial in children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906). We report immunogenicity of IIV3 and inactivated polio vaccine (IPV) from that trial. We evaluated hemagglutination inhibition (HAI) and polio antibody titers in response to vaccination of three age groups (6 through 35 months, 3 through 5 years, and 6 through 8 years). As all children were IIV naïve, each received two vaccine doses, although titers were assessed after only the first dose for subjects aged 6 through 8 years. Seroconversion rates (4-fold titer rise or increase from <1:10 to ≥1:40) were 74-87% for A/H1N1, 76-87% for A/H3N2, and 54-79% for B/Yamagata. Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata. IIV responses were lowest in the youngest age group, and they were comparable between ages 3 through 5 years after two doses and 6 through 8 years after one dose. We found that baseline seropositivity (HAI titer ≥ 1:10) was an effect modifier of IIV response. Using a seroprotective titer (HAI titer ≥ 1:160) recommended for IIV evaluation in children, we found that among subjects who were seropositive at baseline, 69% achieved seroprotection for both A/H1N1 and A/H3N2, while among those who were seronegative at baseline, seroprotection was achieved in 11% for A/H1N1 and 22% for A/H3N2. The IPV group had high baseline polio antibody seropositivity and appropriate responses to vaccination. Our data emphasize the importance of a two-dose IIV3 series in vaccine naïve children. IIV and IPV vaccines were immunogenic in Senegalese children.",2020,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","['children are limited from tropical developing countries', 'children in rural Senegal during 2009, a year of H3N2 vaccine mismatch (NCT00893906', 'Senegalese children', 'vaccine naïve children', 'three age groups (6 through 35\xa0months, 3 through 5\xa0years, and 6 through 8\xa0years', 'children in Senegal']","['IIV3 and inactivated polio vaccine (IPV', 'trivalent inactivated influenza vaccine (IIV', 'seasonal inactivated influenza and inactivated polio vaccines']","['Seroprotection rates', 'hemagglutination inhibition (HAI) and polio antibody titers', 'Seroconversion rates', 'IIV responses', 'seroprotection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337846', 'cui_str': 'Senegalese'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",,0.0885076,"Seroprotection rates (HAI titer ≥ 1:40) were 79-88% for A/H1N1, 88-96% for A/H3N2, and 52-74% for B/Yamagata.","[{'ForeName': 'Mbayame', 'Initials': 'M', 'LastName': 'Niang', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Meagan E', 'Initials': 'ME', 'LastName': 'Deming', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA; Institute of Human Virology, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Goudiaby', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Ousmane M', 'Initials': 'OM', 'LastName': 'Diop', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Ndongo', 'Initials': 'N', 'LastName': 'Dia', 'Affiliation': 'National Influenza and Other Respiratory Viruses Center, Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Diop', 'Affiliation': 'PATH, Dakar, Senegal.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium; Division Global Health Protection, Centers for Disease Control and Prevention, Nairobi, Kenya.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, WA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA. Electronic address: kneuzil@som.umaryland.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.09.059']
3364,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE


Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN


Double-blinded randomized placebo-controlled trial.
SETTING


Labor and delivery triage room.
PATIENTS


Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS


Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS


The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS


Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95%  = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95%  = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95%  = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95%  = -4.93, -0.34]; P = 0.025).
CONCLUSION


Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95%  = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
3365,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION


E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD


The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS


The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS


Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
3366,33038685,Intrinsic foot muscle strengthening exercises with electromyographic biofeedback achieve increased toe flexor strength in older adults: A pilot randomized controlled trial.,"BACKGROUND


Toe flexor strength is important for preventing older adults from falling. Although intrinsic foot muscles are the main determinants of toe flexor strength, exercises for strengthening these muscles are difficult for older adults. This study therefore aimed to determine whether the use of electromyographic biofeedback helps older adults to perform intrinsic foot muscle strengthening exercises.
METHODS


This randomized controlled trial had two parallel arms. Participants were randomly allocated to the control group or the electromyographic biofeedback group. Control participants performed two progressive intrinsic foot muscle strengthening exercises twice a week for 6 weeks. Participants in the other group performed these exercises assisted by electromyographic biofeedback. Primary outcome measures were changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests).
FINDINGS


Altogether, 23 older adults were randomized to the control group (n = 12) or the electromyographic biofeedback group (n = 11). After the 6-week intervention, toe flexor strength on the dominant side increased in both groups (P < 0.017). However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5. There were no changes in the two balance tests. Three of the control group and two of the electromyographic biofeedback group were lost to follow- up.
INTERPRETATION


Our results indicate that, the use of electromyographic biofeedback can enhance the effect of intrinsic foot muscle strengthening exercises on the nondominant side in older adults.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000036521.",2020,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","['older adults', 'older adults from falling', '23 older adults']","['electromyographic biofeedback', 'exercises assisted by electromyographic biofeedback', 'progressive intrinsic foot muscle strengthening exercises', 'Intrinsic foot muscle strengthening exercises with electromyographic biofeedback', 'electromyographic biofeedback group']","['toe flexor strength on the nondominant side', 'toe flexor strength', 'changes in toe flexor strength and the timed up-and-go and functional reach tests (the latter two being balance tests']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0204624', 'cui_str': 'Electromyographic biofeedback'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",23.0,0.0409907,"However, toe flexor strength on the nondominant side increased only in the electromyographic biofeedback group (P < 0.017), with a large effect size of 1.5.","[{'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okamura', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: k-okamura@pu-hiroshima.ac.jp.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Egawa', 'Affiliation': 'Graduate School of Comprehensive Scientific Research, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan; Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okii', 'Affiliation': 'Okii Clinic, 4-5-10 Motomachi, Iwakuni, Yamaguchi 740-0012, Japan.'}, {'ForeName': 'Sadaaki', 'Initials': 'S', 'LastName': 'Oki', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: oki@pu-hiroshima.ac.jp.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Kanai', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, 1-1 Gakuen-cho, Mihara, Hiroshima 723-0053, Japan. Electronic address: kanai@pu-hiroshima.ac.jp.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105187']
3367,33044178,A Randomized Clinical Trial of Greek High Phenolic Early Harvest Extra Virgin Olive Oil in Mild Cognitive Impairment: The MICOIL Pilot Study.,"BACKGROUND


Extra virgin olive oil (EVOO) constitutes a natural compound with high protection over cognitive function.
OBJECTIVE


To investigate for the first time the effect of Greek High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) versus Moderate Phenolic (MP-EVOO) and Mediterranean Diet (MeDi) in people with mild cognitive impairment (MCI).
METHODS


We conducted a randomized prospective study so as to examine the HP-EH-EVOO and MP-EVOO versus MeDi in MCI. Genetic predisposition (APOEɛ4) to Alzheimer's disease (AD) was tested and an extensive neuropsychological battery was administered at baseline and after 12 months. Each participant was randomized and assigned one of three groups: 1) Group 1 received the HP-EH-EVOO (50 mL/day); 2) Group 2 received the MP-EVOO (50 mL/day), and 3) Group 3 received only the MeDi instructions.
RESULTS


Better follow-up performance was found in Group 1 compared to Group 2 and Group 3 in the almost all cognitive domains. Moreover, Group 2 showed also significant improvement compared to Group 3 in ADAS-cog (p = 0.001) and MMSE (p = 0.05), whereas Group 3 exhibited worse or similar to baseline performance in almost all domains. In particular, Group 1 and Group 2 had better outcomes with regards to ADAS-cog (p = 0.003), Digit Span (p = 0.006), and Letter fluency (p = 0.003). Moreover, there was a significant difference (p = 0.001) in the presence of APOEɛ4 between the Groups 1 and 2 versus Group 3.
CONCLUSION


Long-term intervention with HP-EH-EVOO or MP-EVOO was associated with significant improvement in cognitive function compared to MeDi, independent of the presence of APOEɛ4.",2020,"RESULTS


Better follow-up performance was found in Group 1 compared to Group 2 and Group 3 in the almost all cognitive domains.","['people with mild cognitive impairment (MCI', 'Mild Cognitive Impairment']","['HP-EH-EVOO and MP-EVOO versus MeDi', 'Greek High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) versus Moderate Phenolic (MP-EVOO) and Mediterranean Diet (MeDi', 'MeDi instructions', 'Greek High Phenolic Early Harvest Extra Virgin Olive Oil', 'HP-EH-EVOO', 'MP-EVOO', 'Extra virgin olive oil (EVOO', 'HP-EH-EVOO or MP-EVOO']","['Letter fluency', 'cognitive function', 'presence of APOEɛ4', 'MMSE', 'Digit Span']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]",,0.141676,"RESULTS


Better follow-up performance was found in Group 1 compared to Group 2 and Group 3 in the almost all cognitive domains.","[{'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Tsolaki', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Eftychia', 'Initials': 'E', 'LastName': 'Lazarou', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Mahi', 'Initials': 'M', 'LastName': 'Kozori', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Petridou', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tabakis', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Ioulietta', 'Initials': 'I', 'LastName': 'Lazarou', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karakota', 'Affiliation': ""Greek Association of Alzheimer's Disease and Related Disorders, Thessaloniki, Makedonia, Greece.""}, {'ForeName': 'Iordanis', 'Initials': 'I', 'LastName': 'Saoulidis', 'Affiliation': 'Department of Neurology General University Hopsital ""AHEPA"", Medical School, Faculty of Health Sciences, Aristotle University of Thessaloniki, Makedonia, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Melliou', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, Athens, Greece.'}, {'ForeName': 'Prokopios', 'Initials': 'P', 'LastName': 'Magiatis', 'Affiliation': 'Department of Pharmacognosy and Natural Products Chemistry, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, Athens, Greece.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200405']
3368,33039650,"Derepression of glomerular filtration, renal blood flow and antioxidant defence in patients with type 2 diabetes at high-risk of cardiorenal disease.","BACKGROUND


The role of antioxidant status on microvascular blood flow and glomerular filtration (eGFR) in patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity is unknown.
METHODS


Adult, non-Caucasian (n = 101) and Caucasian (n = 69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73 m 2  were randomised to receive 400 IU vitamin E and/or 20 μg selenium daily or matching placebo. eGFR (CKD-EPI) was measured at baseline, 3,6 and 12 months and renal blood flow by contrast-enhanced ultrasonography in a sub-group (n = 9) at baseline and 3 months by assessing the area under the time intensity curve (TIC). Circulating glutathione peroxidase 3 (GPx-3) activity was measured as a biomarker of oxidative defence status.
RESULTS


The time to change in eGFR was shortest with combined vitamin E and selenium than usual care (5.6 [4.0-7.0] vs 8.9 [6.8-10.9 months]; p = 0.006). Area under the TIC was reduced compared to baseline (38.52 [22.41-90.49] vs 123 [86.98-367.03]dB.s; P ≤ 0.05 and 347 [175.88-654.92] vs 928.03 [448.45-1683]dB.s; P ≤ 0.05, respectively] at 3 months suggesting an increase in rate of perfusion. The proportional change in eGFR at 12 months was greater in the group whose GPx-3 activity was above, compared with those below the cohort median (360 U/L) in the non-Caucasian and the Caucasian groups (19.1(12.5-25.7] % vs 6.5[-3.5 to 16.5] % and 12.8 [0.7 to 24] % vs 0.2 [-6.1 to 6.5] %).
CONCLUSION


In these patients with type 2 diabetes and early CKD, antioxidant treatment derepresses renal blood flow and a rise in eGFR correlated directly with GPx-3 activity.
SIGNIFICANCE


Diabetes mellitus is the world's leading cause of end-stage renal disease which has a predilection for black and minor ethnic groups compared with Caucasians. The differences in risk despite the benefits of conventional care may be related to oxidative stress. We found that glomerular filtration and renal blood flow is suppressed when renal function is preserved in high-risk patients with type 2 diabetes. Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) - improves renal perfusion and increase glomerular filtration according to host antioxidant defence determined by GPx-3 activity. Circulating GPx-3 activity warrants further investigation as a novel biomarker of reversible haemodynamic changes in early diabetic kidney disease to better enable targeting of renoprotective strategies.",2020,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","['patients with type 2 diabetes at high-risk of cardiorenal disease', 'patients with type 2 diabetes and hypertension whose risk of progressive renal disease varies by ethnicity', 'high-risk patients with type 2 diabetes', 'Adult, non-Caucasian (n=101) and Caucasian (n=69) patients with type 2 diabetes, hypertension and/or microalbuminuria and an eGFR > 45 mL/min/1.73m 2', 'Diabetes mellitus']","['selenium daily or matching placebo', 'combined vitamin E and selenium', 'Conventional care supplemented with selenium - the co-factor for glutathione peroxidase-3 (GPx-3) ', '400 IU vitamin E']","['glomerular filtration and renal blood flow', 'renal blood flow and glomerular filtration', 'microvascular blood flow and glomerular filtration (eGFR', 'eGFR (CKD-EPI', 'rate of perfusion', 'Circulating glutathione peroxidase 3 (GPx-3) activity', 'renal blood flow', 'GPx-3 activity', 'proportional change in eGFR', 'time to change in eGFR', 'Derepression of glomerular filtration, renal blood flow and antioxidant defence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0035070', 'cui_str': 'Circulation, Renal'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1436542', 'cui_str': 'GPX3 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",,0.0397352,"Area under the TIC was reduced compared to baseline (38.52 [22.41- 90.49] vs 123 [86.98- 367.03]dB.s; P≤0.05 and 347 [175.88- 654.92] vs 928.03 [448.45-1683]dB.s; P≤0.05, respectively] at 3 months suggesting an increase in rate of perfusion.","[{'ForeName': 'Karima', 'Initials': 'K', 'LastName': 'Zitouni', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'M R C P', 'Initials': 'MRCP', 'LastName': 'Steyn', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Lyka', 'Affiliation': 'St Georges University of London, Institute of Biomedical & Medical Education, London, UK.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Kelly', 'Affiliation': 'Kings College London, Analytical, Environmental and Forensic Sciences Department, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cook', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Trace Element Unit, Southampton, UK.'}, {'ForeName': 'Irina Chis', 'Initials': 'IC', 'LastName': 'Ster', 'Affiliation': 'St Georges University of London, Institute of Infection and Immunity, London, UK.'}, {'ForeName': 'Kenneth Anthony', 'Initials': 'KA', 'LastName': 'Earle', 'Affiliation': 'St Georges University Hospitals NHS Foundation Trust, Thomas Addison Unit, London, UK; St Georges University of London, Institute of Biomedical & Medical Education, London, UK. Electronic address: kearle@sgul.ac.uk.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.10.005']
3369,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE


The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN


A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING


Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS


63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS


All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES


Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS


Significant interaction Group*Time effects scales (F 2,126  = 5.1, p-level = 0.005, η² p  = 0.25; F 2,126  = 4.7, p-level = 0.007, η² p  = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION


The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
3370,33004464,The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial.,"OBJECTIVE


To explore the effects of empagliflozin on the incidence of obstructive sleep apnea (OSA) and its effects on metabolic, cardiovascular (CV), and renal outcomes among participants with or without OSA in the EMPA-REG OUTCOME trial.
RESEARCH DESIGN AND METHODS


Participants with diabetes and CV disease were randomized to empagliflozin (10 and 25 mg) or placebo daily in addition to standard of care. OSA was assessed by investigator report using Medical Dictionary for Regulatory Activities version 18.0, and CV outcomes were independently adjudicated. Analyses were performed using multivariable-adjusted Cox regression models.
RESULTS


OSA was reported in 391 of 7,020 (5.6%) participants at baseline. Those with OSA were more likely to be male (83% vs. 71%) and to have moderate to severe obesity (BMI ≥35 kg/m 2 ; 55% vs. 18%). Over a median of 3.1 years, empagliflozin had similar placebo-adjusted reductions in HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status, but a larger effect on weight (adjusted mean ± SE difference at week 52: OSA vs. no OSA -2.9 ± 0.5 vs. -1.9 ± 0.1 kg). Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy in the placebo group was 1.2- to 2.0-fold higher for those with baseline OSA compared with those without. Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all >0.05). Fifty patients reported a new diagnosis of OSA through 7 days after medication discontinuation, and this occurred less often with empagliflozin treatment (hazard ratio 0.48 [95% CI 0.27, 0.83]).
CONCLUSIONS


In EMPA-REG OUTCOME, participants with OSA had greater comorbidity and higher frequency of CV and renal events. Empagliflozin had favorable effects on risk factors and CV and renal outcomes regardless of preexisting OSA and may also reduce the risk for new-onset OSA.",2020,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"['participants with or without OSA in the EMPA-REG OUTCOME trial', 'Participants with diabetes and CV disease']","['placebo', 'Empagliflozin', 'empagliflozin']","['new diagnosis of OSA', 'OSA status', 'comorbidity and higher frequency of CV and renal events', 'HbA 1c , waist circumference, and systolic blood pressure, regardless of OSA status', 'moderate-severe obesity', 'Incidence of 3-point major adverse CV events, CV death, heart failure hospitalization, and incident or worsening nephropathy', 'metabolic, cardiovascular (CV), and renal outcomes', 'OSA', 'Obstructive Sleep Apnea, Cardiovascular, and Renal Outcomes', 'obstructive sleep apnea (OSA']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.196974,Empagliflozin significantly reduced the risk for outcomes regardless of OSA status ( P -interaction all > 0.05).,"[{'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'University Hospitals Harrington Heart and Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, OH ian.neeland@uhhospitals.org.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Eliasson', 'Affiliation': 'Department of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I (Cardiology), RWTH University Hospital, Aachen, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Wuerzburg University Clinic, Wuerzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Wojeck', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Henry K', 'Initials': 'HK', 'LastName': 'Yaggi', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, Yale University, New Haven, CT.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1096']
3371,33004472,The Role of Glucagon in the Acute Therapeutic Effects of SGLT2 Inhibition.,"Sodium-glucose cotransporter 2 inhibitors (SGLT2i) effectively lower plasma glucose (PG) concentration in patients with type 2 diabetes, but studies have suggested that circulating glucagon concentrations and endogenous glucose production (EGP) are increased by SGLT2i, possibly compromising their glucose-lowering ability. To tease out whether and how glucagon may influence the glucose-lowering effect of SGLT2 inhibition, we subjected 12 patients with type 2 diabetes to a randomized, placebo-controlled, double-blinded, crossover, double-dummy study comprising, on 4 separate days, a liquid mixed-meal test preceded by single-dose administration of either  1 ) placebo,  2 ) the SGLT2i empagliflozin (25 mg),  3 ) the glucagon receptor antagonist LY2409021 (300 mg), or  4 ) the combination empagliflozin + LY2409021. Empagliflozin and LY2409021 individually lowered fasting PG compared with placebo, and the combination further decreased fasting PG. Previous findings of increased glucagon concentrations and EGP during acute administration of SGLT2i were not replicated in this study. Empagliflozin reduced postprandial PG through increased urinary glucose excretion. LY2409021 reduced EGP significantly but gave rise to a paradoxical increase in postprandial PG excursion, which was annulled by empagliflozin during their combination (empagliflozin + LY2409021). In conclusion, our findings do not support that an SGLT2i-induced glucagonotropic effect is of importance for the glucose-lowering property of SGLT2 inhibition.",2020,"LY2409021 reduced EGP significantly, but gave rise to a paradoxical increase in postprandial PG excursion, which was annulled by empagliflozin during their combination (empagliflozin+LY2409021).","['patients with type 2 diabetes', '12 patients with type 2 diabetes']","['empagliflozin', 'glucagon', 'placebo, 2) the SGLT2i empagliflozin', 'placebo', 'glucagon receptor antagonist LY2409021 (300 mg), and 4) the combination empagliflozin+LY2409021', 'Glucagon', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors (SGLT2i', 'Empagliflozin']","['plasma glucose (PG) concentration', 'postprandial PG via increased urinary glucose excretion', 'fasting PG', 'postprandial PG excursion', 'glucagon concentrations and EGP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C4077912', 'cui_str': 'LY2409021'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}]",12.0,0.36512,"LY2409021 reduced EGP significantly, but gave rise to a paradoxical increase in postprandial PG excursion, which was annulled by empagliflozin during their combination (empagliflozin+LY2409021).","[{'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Nielsen-Hannerup', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Maagensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes,['10.2337/db20-0369']
3372,33007709,Non-invasive ventilation improves exercise tolerance and peripheral vascular function after high-intensity exercise in COPD-HF patients.,"AIM


Evaluate the acute effects of non-invasive positive pressure ventilation (NiPPV) during high-intensity exercise on endothelial function in patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF).
METHODS


This is a randomized, double blinded, sham-controlled study involving 14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography. On two different days, patients performed incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV (bilevel mode - Astral 150) in a random order until the limit of tolerance (Tlim). Endothelial function was evaluated by flow mediated vasodilation (FMD) at three time points: 1) Baseline; 2) immediately post-exercise with NiPPV; and 3) immediately post-exercise with Sham.
RESULTS


Our patients had a mean age of 70 ± 7 years, FEV 1  1.9 ± 0.7 L and LVEF 41 ± 9%. NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s p = 0.015) and SpO 2  (NiPPV: 94.7 ± 3.5% vs Sham: 92.7 ± 5.2% p = 0.03). Also, NiPPV was able to produce a significant increase in FMD (%) (NiPPV: 9.2 ± 3.1 vs Sham: 3.6 ± 0.7, p < 0.05), FMD (mm) (NiPPV: 0.41 ± 0.18 vs Sham: 0.20 ± 0.11, p < 0.05), Blood flow velocity (NiPPV: 33 ± 18 vs Baseline: 20 ± 14, p < 0.05) and Shear Stress (SS) (NiPPV: 72 ± 38 vs Baseline: 43 ± 25, p < 0.05). We found correlation between Tlim vs. ΔSS (p = 0.03; r = 0.57). Univariate-regression analysis revealed that increased SS influenced 32% of Tlim during exercise with NiPPV.
CONCLUSION


NiPPV applied during high-intensity exercise can acutely modulate endothelial function and improve exercise tolerance in COPD-HF patients. In addition, the increase of SS positively influences exercise tolerance.",2020,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"['patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF', 'Our patients had a mean age of 70\xa0±\xa07 years, FEV 1', '14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography', 'COPD-HF patients']","['non-invasive positive pressure ventilation (NiPPV', 'NIPPV', 'high-intensity exercise', 'incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV', 'NiPPV']","['Shear Stress (SS) ', 'SS positively influences exercise tolerance', 'Blood flow velocity', 'FMD', 'Endothelial function', 'exercise tolerance and peripheral vascular function', 'exercise tolerance', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0055954', 'cui_str': 'Clostridium perfringens epsilon toxin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",14.0,0.444389,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"[{'ForeName': 'Cássia', 'Initials': 'C', 'LastName': 'da Luz Goulart', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: Luz.cassia@hotmail.com.'}, {'ForeName': 'Flávia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: fla.rossi@hotmail.com.'}, {'ForeName': 'Adriana S', 'Initials': 'AS', 'LastName': 'Garcia de Araújo', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: garciadrica@hotmail.com.'}, {'ForeName': 'Guilherme Peixoto', 'Initials': 'GP', 'LastName': 'Tinoco Arêas', 'Affiliation': 'Human Physiology Laboratory, Physiology Department, Federal University of Amazonas, UFAM, Manaus, AM, Brazil. Electronic address: Guilhermepta@hotmail.com.'}, {'ForeName': 'Sílvia Cristina', 'Initials': 'SC', 'LastName': 'Garcia de Moura', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: silvinhacgmoura@gmail.com.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: amcatai50@gmail.com.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: mendesrg@hotmail.com.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: shanep@uic.edu.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: rarena70@gmail.com.'}, {'ForeName': 'Andréa Lúcia', 'Initials': 'AL', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Department of Physical Education and Health, University of Santa Cruz do Sul, Rio Grande do Sul, Brazil. Electronic address: andreag@unisc.br.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106173']
3373,33011539,Genital Self-Image in Adolescent Girls: The Effectiveness of a Brief Educational Video.,"The study investigated the effectiveness of a very brief video aimed at increasing adolescent girls' knowledge of the variation in normal female genital appearance and improving their attitudes towards their own genitals. The video was developed by the researchers and included information about the anatomical features of cisgender female genitals and their function, as well as emphasizing the diversity in the appearance of these features, particularly the external genitalia or vulvar region. A sample of 343 female adolescents aged 16-18 years were randomly assigned to view the educational video or a control video. The educational video significantly increased the girls' knowledge of female genital anatomy. The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future. The participants who watched the educational video were also more likely to recommend focusing on the diversity in normal female genital appearance when educating other young people on the topic of female genital anatomy. Our results suggest that a very brief educational video could be a useful tool to assist young girls with their genital self-image.",2020,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"['adolescent girls', '343 female adolescents aged 16-18 years', 'Adolescent Girls']","['educational video or a control video', 'Brief Educational Video']","['genital appearance satisfaction', 'Genital Self-Image', ""girls' knowledge of female genital anatomy""]","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0017421', 'cui_str': 'Female genital'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}]",343.0,0.014125,The educational video also significantly increased genital appearance satisfaction and decreased consideration of undergoing cosmetic genital surgery or labiaplasty in the future.,"[{'ForeName': 'Anne Nileshni', 'Initials': 'AN', 'LastName': 'Fernando', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: anfer4@student.monash.edu.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sharp', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Monash University, Melbourne, Victoria, 3004, Australia. Electronic address: gemma.sharp@monash.edu.'}]",Body image,['10.1016/j.bodyim.2020.08.007']
3374,33014330,Effects of stratified medication review in high-risk patients at admission to hospital: a randomised controlled trial.,"Background


Patients at high risk of medication errors will potentially benefit most from medication reviews. An algorithm, MERIS, can identify the patients who are at highest risk of medication errors. The aim of this study was to examine the effects of performing stratified medication reviews on patients who according to MERIS were at highest risk of medication errors.
Methods


A randomised controlled trial was performed at the Acute Admissions Unit, Aarhus University Hospital, Denmark. Patients were included at admission to the hospital and were randomised to control or intervention. The intervention consisted of stratified medication review at admission on patients with a high MERIS score. Clinical pharmacists and clinical pharmacologists performed the medication reviews; the clinical pharmacologists performed the reviews on patients with the highest MERIS score. The primary outcome measure was the number of prescribing errors during the hospitalisation. Secondary outcomes included self-experienced quality of life, health-care utilisation and mortality measured at follow-up 90 days after discharge.
Results


A total of 375 patients were included, of which medication reviews were performed in 64 patients. The medication reviews addressed 63 prescribing errors in 37 patients and 60 other drug-related problems. No difference in the number of prescribing errors during hospitalisation between the intervention group ( n  = 165) and control group ( n  = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08-0.14)  versus  0.13 per drug (95% CI: 0.09-0.16), respectively. No differences in secondary outcomes were observed.
Conclusion


A stratified medication review approach based on the individual patient's risk of medication errors did not show impact on the chosen outcomes.
Plain language summary


How does a medication review at admission affect patients who are in high risk of medication errors?  Patients are at risk of medication errors at admission to hospital. Medication reviews aim to detect and solve these. Yet, due to limited resources in healthcare, it would be beneficial to detect the patients who are most at risk of medication errors and perform medication reviews on those patients.In this study we investigated whether an algorithm, MERIS, could detect patients who are at highest risk of medication errors; we also studied whether performing medication reviews on patients at highest risk of medication errors would have an effect on, for example, the number of medication errors during hospitalisation, qualify of life and number of readmissions. We included 375 patients in a Danish acute admission unit and they were divided into control group and intervention group. Patients in the intervention group received a medication review at admission if they were considered at high risk of medication errors, assessed with the aid of MERIS. In summary, 64 patients in the intervention group were most at risk of medication errors and therefore received a medication review.We conclude in the study that MERIS was useful in identifying relevant patients for medication reviews. Yet, the medication reviews performed at admission did not impact on the chosen outcomes.",2020,"No difference in the number of prescribing errors during hospitalisation between the intervention group ( n  = 165) and control group ( n  = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08-0.14)  versus  0.13 per drug (","['A total of 375 patients were included, of which medication reviews were performed in 64 patients', '375 patients in a Danish acute admission unit and they were divided into control group and intervention group', 'patients who according to MERIS were at highest risk of medication errors', 'patients who are at highest risk of medication errors', '37 patients and 60 other drug-related problems', 'Acute Admissions Unit, Aarhus University Hospital, Denmark', 'Patients were included at admission to the hospital', 'high-risk patients at admission to hospital']",['MERIS'],"['number of prescribing errors during hospitalisation', 'self-experienced quality of life, health-care utilisation and mortality', 'number of prescribing errors during the hospitalisation', 'risk of medication errors']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}]",375.0,0.0520952,"No difference in the number of prescribing errors during hospitalisation between the intervention group ( n  = 165) and control group ( n  = 153) was found, corresponding to 0.11 prescribing errors per drug (95% confidence interval (CI): 0.08-0.14)  versus  0.13 per drug (","[{'ForeName': 'Dorthe Krogsgaard', 'Initials': 'DK', 'LastName': 'Bonnerup', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Randers Regional Hospital, Dronningborg Boulevard 16D, DK-8930 Randers NØ, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Research Centre for Emergency Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Eva Aggerholm', 'Initials': 'EA', 'LastName': 'Sædder', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brock', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Truelshøj', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Denmark.'}, {'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Denmark.'}, {'ForeName': 'Anita Gorm', 'Initials': 'AG', 'LastName': 'Pedersen', 'Affiliation': 'Hospital Pharmacy, Central Denmark Region, Denmark.'}, {'ForeName': 'Lars Peter', 'Initials': 'LP', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Pharmacology, Aarhus University Hospital, Denmark.'}]",Therapeutic advances in drug safety,['10.1177/2042098620957142']
3375,33020646,Continuous versus intermittent BRAF and MEK inhibition in patients with BRAF-mutated melanoma: a randomized phase 2 trial.,"Preclinical modeling suggests that intermittent BRAF inhibitor therapy may delay acquired resistance when blocking oncogenic BRAF V600  in melanoma 1,2 . We conducted S1320, a randomized, open-label, phase 2 clinical trial (NCT02196181) evaluating whether intermittent dosing of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib improves progression-free survival in patients with metastatic and unresectable BRAF V600  melanoma. Patients were enrolled at 68 academic and community sites nationally. All patients received continuous dabrafenib and trametinib during an 8-week lead-in period, after which patients with non-progressing tumors were randomized to either continuous or intermittent dosing of both drugs on a 3-week-off, 5-week-on schedule. The trial has completed accrual and 206 patients with similar baseline characteristics were randomized 1:1 to the two study arms (105 to continuous dosing, 101 to intermittent dosing). Continuous dosing yielded a statistically significant improvement in post-randomization progression-free survival compared with intermittent dosing (median 9.0 months versus 5.5 months, P = 0.064, pre-specified two-sided α = 0.2). Therefore, contrary to the initial hypothesis, intermittent dosing did not improve progression-free survival in patients. There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.",2020,"There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.","['206 patients with similar baseline characteristics', 'patients with metastatic and unresectable BRAF V600  melanoma', 'patients with non-progressing tumors', 'patients with BRAF-mutated melanoma', 'Patients were enrolled at 68 academic and community sites nationally']","['Continuous versus intermittent BRAF and MEK inhibition', 'BRAF inhibitor dabrafenib and the MEK inhibitor trametinib', 'BRAF inhibitor therapy', 'continuous dabrafenib and trametinib']","['progression-free survival', 'post-randomization progression-free survival', 'overall survival and the overall incidence of treatment-associated toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0169101', 'cui_str': 'MAP Kinase Kinases'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3838813', 'cui_str': 'B-Raf inhibitor'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",206.0,0.105021,"There were no differences in the secondary outcomes, including overall survival and the overall incidence of treatment-associated toxicity, between the two groups.","[{'ForeName': 'Alain P', 'Initials': 'AP', 'LastName': 'Algazi', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA. alain.algazi@ucsf.edu.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Othus', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Adil I', 'Initials': 'AI', 'LastName': 'Daud', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'Lo', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Mehnert', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Thach-Giao', 'Initials': 'TG', 'LastName': 'Truong', 'Affiliation': 'Kaiser Permanente Northern California, Vallejo, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'University of Alabama, Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kendra', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Gary C', 'Initials': 'GC', 'LastName': 'Doolittle', 'Affiliation': 'University of Kansas Hospital-Westwood Cancer Center, Westwood, KS, USA.'}, {'ForeName': 'Joseph I', 'Initials': 'JI', 'LastName': 'Clark', 'Affiliation': 'Loyola University, Chicago, IL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Messino', 'Affiliation': 'Messino Cancer Centers-Asheville/ Southeast COR NCORP/Asheville, Asheville, NC, USA.'}, {'ForeName': 'Dennis F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Cancer Center of Kansas/Wichita NCORP, Wichita, KS, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lao', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Faller', 'Affiliation': 'Missouri Baptist Medical Center Cancer Center/Heartland NCORP, St Louis, MO, USA.'}, {'ForeName': 'Rangaswamy', 'Initials': 'R', 'LastName': 'Govindarajan', 'Affiliation': 'University of Arkansas, Little Rock, AR, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Harker-Murray', 'Affiliation': 'Froedtert and the Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Dreisbach', 'Affiliation': 'Eisenhower Medical Center, Rancho Mirage, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Kenneth F', 'Initials': 'KF', 'LastName': 'Grossmann', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}]",Nature medicine,['10.1038/s41591-020-1060-8']
3376,33020648,"Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i.","Immune and targeted therapies achieve long-term survival in metastatic melanoma; however, new treatment strategies are needed to improve patients' outcomes 1,2 . We report on the efficacy, safety and biomarker analysis from the single-arm safety run-in (part 1; n = 9) and biomarker (part 2; n = 27) cohorts of the randomized, placebo-controlled, phase 3 COMBI-i trial (NCT02967692) of the anti-PD-1 antibody spartalizumab, in combination with the BRAF inhibitor dabrafenib and MEK inhibitor trametinib. Patients (n = 36) had previously untreated BRAF V600-mutant unresectable or metastatic melanoma. In part 1, the recommended phase 3 regimen was identified based on the incidence of dose-limiting toxicities (DLTs; primary endpoint): 400 mg of spartalizumab every 4 weeks plus 150 mg of dabrafenib twice daily plus 2 mg of trametinib once daily. Part 2 characterized changes in PD-L1 levels and CD8 +  cells following treatment (primary endpoint), and analyzed additional biomarkers. Assessments of efficacy and safety were key secondary endpoints (median follow-up, 24.3 months). Spartalizumab plus dabrafenib and trametinib led to an objective response rate (ORR) of 78%, including 44% complete responses (CRs). Grade ≥3 treatment-related adverse events (TRAEs) were experienced by 72% of patients. All patients had temporary dose modifications, and 17% permanently discontinued all three study drugs due to TRAEs. Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR. Overall, the efficacy, safety and on-treatment biomarker modulations associated with spartalizumab plus dabrafenib and trametinib are promising, and biomarkers that may predict long-term benefit were identified.",2020,Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR.,"['metastatic melanoma', 'Patients (n\u2009=\u200936) had previously untreated BRAF V600-mutant unresectable or metastatic melanoma', 'advanced BRAF-mutant melanoma']","['spartalizumab every 4\u2009weeks plus 150\u2009mg of dabrafenib twice daily plus 2\u2009mg of trametinib once daily', 'anti-PD-1 antibody spartalizumab, in combination with the BRAF inhibitor dabrafenib and MEK inhibitor trametinib', 'placebo']","['objective response rate (ORR', 'PD-L1 levels and CD8 +  cells', 'efficacy and safety', 'efficacy, safety', 'Grade\u2009≥3 treatment-related adverse events (TRAEs', 'Early progression-free survival (PFS) events']","[{'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}]","[{'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3467876', 'cui_str': 'dabrafenib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C3838813', 'cui_str': 'B-Raf inhibitor'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.208807,Early progression-free survival (PFS) events were associated with low tumor mutational burden/T cell-inflamed gene expression signature (GES) or high immunosuppressive tumor microenvironment (TME) GES levels at baseline; an immunosuppressive TME may also preclude CR.,"[{'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'University Hospital Zürich Skin Cancer Center, Zurich, Switzerland. Reinhard.Dummer@usz.ch.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'APHP Hôpital Saint-Louis, Dermatology and CIC, Université de Paris, Paris, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Greenslopes Private Hospital, Gallipoli Medical Research Foundation, University of Queensland, Greenslopes, Queensland, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Papa Giovanni XXIII Cancer Center Hospital, Bergamo, Italy.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Richtig', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen and German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Tawbi', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': ""Istituto Nazionale Tumori IRCCS Fondazione 'G. Pascale', Naples, Italy.""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pakhle', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Catarina D', 'Initials': 'CD', 'LastName': 'Campbell', 'Affiliation': 'Novartis Institutes for BioMedical Research, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gusenleitner', 'Affiliation': 'Novartis Institutes for BioMedical Research, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Masood', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gasal', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, The University of Sydney and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia.'}]",Nature medicine,['10.1038/s41591-020-1082-2']
3377,33026166,Identifying the best regimen for primary eradication of Helicobacter pylori: analysis of 240 cases.,"The treatment regimen for the eradication of Helicobacter pylori may be best when therapy is susceptibility guided. However, it is unrealistic to use a strategy based on susceptibility testing to prioritize therapy for every patient in China. Empirical therapy of H. pylori is still widely used. The study was designed to discuss the best first-line treatment regimen depending on empirical therapy. The focal point of the study was the optimal length of the therapy. Also, the selection of antibiotics was discussed in the article. This was a prospective, randomized, non-inferiority trial. H. pylori-infected patients who have no previous eradication therapy were randomly assigned to the following: 20 mg of rabeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, and 220 mg of bismuth potassium citrate (BACPPI), administered twice a day for 10 or 14 days. The efficacy, side effects, and remission rate of clinical symptoms were determined. A total of 240 subjects were included in the study. The eradication rate with 14 and 10 days was essentially identical in both intention-to-treat (90.83% [95% CI, 86%-96%] vs. 87.50% [95% CI, 82%-93%]) and per-protocol (94.78% [95% CI, 91%-99%] vs. 92.11% [95% CI, 87%-97%]) analyses. Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment. Side effects were generally mild and similar between groups. Our results showed that a 10-day amoxicillin-clarithromycin-containing bismuth quadruple therapy may be recommended for the primary empirical treatment of H. pylori infection in Beijing, China.",2020,Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment.,"['H.\xa0pylori-infected patients who have no previous eradication therapy', '240 cases', 'A total of 240 subjects were included in the study']","['amoxicillin-clarithromycin-containing bismuth quadruple therapy', 'BACPPI-10', 'rabeprazole', 'amoxicillin, 500\xa0mg of clarithromycin, and 220\xa0mg of bismuth potassium citrate (BACPPI']","['eradication rate', 'Side effects', 'efficacy, side effects, and remission rate of clinical\xa0symptoms', 'Loss of appetite and belching symptoms']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}]",240.0,0.0356055,Loss of appetite and belching symptoms were significantly better in the BACPPI-10 group than those in the control group after treatment.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Traditional Chinese Medicine, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Qingyi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Domestic Department One, The Second Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fulian', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jizheng', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital, Beijing, China.'}]",MicrobiologyOpen,['10.1002/mbo3.1120']
3378,33022483,The Norwegian healthy body image intervention promotes positive embodiment through improved self-esteem.,"We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students. In total, 2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the HBI intervention and a control condition as the study arms. We tested mediation models using path analysis and found that among several hypothesized mediators, only self-esteem mediated a positive intervention effect on positive embodiment for both boys and girls. A direct effect of the intervention on positive embodiment was only found in girls. The study provides novel findings indicating that health promotion interventions to address a positive embodiment should focus on enhancing adolescent's self-esteem. Serial mediation modeling might reveal more complex explanations of change mechanisms and could further evolve current knowledge.",2020,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"['girls', 'Norwegian high school students', '2446 12th grade boys (43 %) and girls (mean age 16.8 years) from 30 schools participated in a cluster-randomized controlled study with the']","['HBI intervention', 'Healthy Body Image (HBI) intervention']",['positive embodiment'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0192935,We examined both direct and indirect effects of the Healthy Body Image (HBI) intervention on positive embodiment among Norwegian high school students.,"[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: chrsun@ous-hf.no.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stenling', 'Affiliation': 'Umeå University, Department of Psychology, 901 87 Umeå, Sweden. Electronic address: andreas.stenling@umu.se.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rosenvinge', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: jan.rosenvinge@uit.no.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Health and Caring Sciences, N- 9037 Tromsø, Norway. Electronic address: gunn.pettersen@uit.no.'}, {'ForeName': 'Oddgeir', 'Initials': 'O', 'LastName': 'Friborg', 'Affiliation': 'UiT -The Arctic University of Norway, Faculty of Health Sciences Department of Psychology, 9037 Tromsø, Norway. Electronic address: oddgeir.friborg@uit.no.'}, {'ForeName': 'Jorunn', 'Initials': 'J', 'LastName': 'Sundgot-Borgen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: jorunn.sundgot-borgen@nih.no.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: elin.kolle@nih.no.'}, {'ForeName': 'Monica Klungland', 'Initials': 'MK', 'LastName': 'Torstveit', 'Affiliation': 'University of Agder, Faculty of Health and Sport Sciences, Postbox 422, 4604 Kristiansand, Norway. Electronic address: monica.k.torstveit@uia.no.'}, {'ForeName': 'Kethe M E', 'Initials': 'KME', 'LastName': 'Svantorp-Tveiten', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Sognsveien 220, N-0806 Oslo, Norway. Electronic address: k.m.e.engen@nih.no.'}, {'ForeName': 'Solfrid', 'Initials': 'S', 'LastName': 'Bratland-Sanda', 'Affiliation': 'University College of Southeast Norway, Department of Sports, Physical Education and Outdoor Studies, P.O. Box 235, N-3603 Kongsberg, Norway. Electronic address: Solfrid.Bratland-Sanda@usn.no.'}]",Body image,['10.1016/j.bodyim.2020.08.014']
3379,33024260,Does crossover treatment of control subjects invalidate results of randomized trials of patent ductus arteriosus treatment?,"Optimal management of patent ductus arteriosus (PDA) in extremely preterm infants remains controversial. There is paucity of evidence on the benefits of PDA treatment in reducing mortality and morbidities in extremely preterm infants. Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects. This perspective examines the PDA treatment trials to date, with specific focus on rates of and ages of subjects at open rescue treatment. Although these trials demonstrate that ductal closure is significantly increased with treatment, that does not translate to a significant decrease in major morbidities or mortality in premature infants, even when trials with high rates of rescue treatment of controls are excluded. Trials in which enrollment occurred after 7 days of age include insufficient numbers of subjects to evaluate this relationship.",2020,Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects.,"['extremely preterm infants', 'premature infants']","['patent ductus arteriosus (PDA', 'patent ductus arteriosus treatment', 'PDA']","['major morbidities or mortality', 'mortality and morbidities']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0459007,Failure of randomized clinical trials to demonstrate beneficial effects of PDA treatment on outcomes has often been attributed to open treatment of control subjects.,"[{'ForeName': 'Meera N', 'Initials': 'MN', 'LastName': 'Sankar', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA. mnsankar@stanford.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Benitz', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00848-z']
3380,33027267,The role of health education on cervical cancer screening uptake at selected health centers in Addis Ababa.,"INTRODUCTION


Cervical cancer is one of the most common causes of morbidity and mortality among women in developing countries including Ethiopia. Unlike other types of cancers, the grave outcomes of cervical cancer could be prevented if detected at its early stage. However, in Ethiopia, awareness about the disease and the availability of screening and treatment services is limited. This study aims to determine the role of health education on cervical cancer screening uptake in selected health facilities in Addis Ababa.
METHODS


Two-pronged clustered randomized controlled trial was conducted in 2018 at eight public health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) in Addis Ababa, Ethiopia. Each of the eight health centers were randomly assigned to serve as either an intervention or a control center. A two-pronged clustered randomized controlled trial was conducted in eight public health care centers. All the selected facilities provided cervical cancer screening services using visual inspection with acetic acid (VIA). Four health centers were randomly assigned to the intervention and control arms. The study participants were women aged 30-49 years who sought care at maternal and child health clinics but who had never been screened for cervical cancer. In the intervention health centers, all eligible women received one-to-one health education and educational brochures about cervical cancer and cervical cancer screening. In the control health centers, participants received standard care. Baseline data were collected at recruitment and follow-up data were collected two months after the baseline. For the follow-up data collection, participants (both in the intervention and control arms) were interviewed over the phone to check whether they were screened for cervical cancer.
RESULT


From the 2,140 women who participated in the study, 215 (10%) screened for cervical cancer, where 152(71%) were from the intervention health centers. Seventy-four percent of these participants reported that they learned about the benefits of screening from the one-to-one health education or the brochure. Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls. Women with the educational status of the first degree and those who have a history of sexually transmitted infections (STIs) had higher odds of getting screened (AOR = 2.03,95%CI;(1.15-2.58) and (AOR = 1.55,95%CI;1.01-2.36), respectively.
CONCLUSION AND RECOMMENDATION


Providing focused health education supported by printed educational materials increased the uptake of cervical cancer screening services. Integrating one-to-one health education and providing a take-home educational material into the existing maternal and child health services can help increase cervical cancer screening uptake.",2020,"Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls.","['Four health centers', 'women in developing countries including Ethiopia', 'participants were women aged 30-49 years who sought care at maternal and child health clinics but who had never been screened for cervical cancer', 'eight public health care centers', '2,140 women who participated in the study, 215 (10%) screened for cervical cancer, where 152(71%) were from the intervention health centers', 'cervical cancer screening uptake at selected health centers in Addis Ababa', 'eight health centers', 'Two-pronged clustered randomized controlled trial was conducted in 2018 at eight public health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) in Addis Ababa, Ethiopia', 'selected health facilities in Addis Ababa']","['health education', 'one-to-one health education and educational brochures about cervical cancer and cervical cancer screening', 'visual inspection with acetic acid (VIA']",[],"[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}]",[],2140.0,0.136285,"Women from the intervention health centers had higher odds of getting screened (AOR = 2.43,95%CI;1.58-2.90) than the controls.","[{'ForeName': 'Selamawit Hirpa', 'Initials': 'SH', 'LastName': 'Abu', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Berhan Tassew', 'Initials': 'BT', 'LastName': 'Woldehanna', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Etsehiwot Tilahun', 'Initials': 'ET', 'LastName': 'Nida', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Abigiya Wondimagegnehu', 'Initials': 'AW', 'LastName': 'Tilahun', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mahlet Yigeremu', 'Initials': 'MY', 'LastName': 'Gebremariam', 'Affiliation': 'School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mitike Molla', 'Initials': 'MM', 'LastName': 'Sisay', 'Affiliation': 'School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0239580']
3381,33028243,BMC family practice integrated GP care for patients with persistent physical symptoms: feasibility cluster randomised trial.,"BACKGROUND


Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.
METHODS


A feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.
RESULTS


Two thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.
CONCLUSIONS


It was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.
TRIAL REGISTRATION


NCT02444520  (ClinicalTrials.gov).",2020,Scores in GP knowledge and confidence increased post-training.,"['GP practices (clusters', 'Two thousand nine hundred seventy-eight patients were identified from 18 GP practices', '424 patients who responded with interest in the study, 164 fully met the eligibility criteria', 'Patients with PPS were recruited from participating GP practices before randomisation', 'patients with persistent physical symptoms', 'Patients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS', 'One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study', 'primary care, South London, UK']","['BMC family practice integrated GP care', ""integrated GP care plus treatment as usual' or 'treatment as usual"", 'GPs training']",['Retention rates'],"[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",2978.0,0.121128,Scores in GP knowledge and confidence increased post-training.,"[{'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'UK South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, Maple House, UCL Institute of Mental Health, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': 'Institute for Lifecourse Development, University of Greenwich, Old Royal Naval College, Park Row, Greenwich, London, SE10 9LS, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neurosciences, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC family practice,['10.1186/s12875-020-01269-9']
3382,33046141,A novel  n -3 glyceride mixture enhances enrichment of EPA and DHA after single dosing in healthy older adults: results from a double-blind crossover trial.,"A glyceride mixture of monoglyceride, diglyceride and TAG increases solubilisation and enhances emulsification of n-3 fatty acid (FA)-containing lipids in the stomach. This allows for better access of digestive enzymes, pivotal for the release of bioactive n-3 FA. The objective was to compare the effect of a glyceride formulation and an ethyl ester formulation of EPA + DHA on concentrations of EPA and DHA in plasma following single dosing. We conducted a double-blind crossover trial in which twenty healthy adults aged 50-70 years consumed a single dose (2·8 g EPA + DHA) of each EPA + DHA formulation without a meal in random order separated by a 2-week washout period. EPA and DHA were measured in plasma total lipid over the following 12 h. EPA and DHA in plasma total lipid increased over 12 h with both formulations. A 10-fold greater Δ concentration of EPA, 3-fold greater Δ concentration of DHA and 5-fold greater Δ concentration of EPA + DHA were seen with the glyceride-EPA + DHA. The time at which the maximal concentrations of n-3 FA occurred was 4 h earlier for EPA, 1 h earlier for DHA and 2 h earlier for EPA + DHA when consuming glyceride-EPA + DHA. A mixture of monoglyceride, diglyceride and TAG results in greater and faster incorporation of EPA and DHA into blood plasma lipid in the absence of a fatty meal. This may provide benefit to individuals on a low-fat diet or with digestive impairments and could result in greater efficacy in clinical trials using n-3 FA.",2020,"A glyceride mix of mono, di, and triglycerides increases solubilisation and enhances emulsification of omega-3 (ω-3) fatty acid (FA) containing lipids in the stomach.","['twenty healthy adults aged 50-70 y consumed a single dose (2.8 g EPA+DHA) of each', 'healthy older adults']","['glyceride formulation and an ethyl ester (EE) formulation of EPA+DHA', 'EPA+DHA formulation', 'eicosapentaenoic acid and docosahexaenoic acid']","['maximal concentrations of ω-3 FA', 'concentrations of EPA and DHA in plasma', 'EPA and DHA', 'plasma total lipid', 'EPA and DHA in plasma total lipid']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0017860', 'cui_str': 'Acylglycerols'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0523744', 'cui_str': 'Lipids measurement'}]",20.0,0.284585,"A glyceride mix of mono, di, and triglycerides increases solubilisation and enhances emulsification of omega-3 (ω-3) fatty acid (FA) containing lipids in the stomach.","[{'ForeName': 'Helena L', 'Initials': 'HL', 'LastName': 'Fisk', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}, {'ForeName': 'Grete M', 'Initials': 'GM', 'LastName': 'Kindberg', 'Affiliation': 'BASF Norge AS, Oslo0283, Norway.'}, {'ForeName': 'Svein O', 'Initials': 'SO', 'LastName': 'Hustvedt', 'Affiliation': 'BASF Norge AS, Oslo0283, Norway.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, SouthamptonSO16 6YD, UK.'}]",The British journal of nutrition,['10.1017/S0007114520004031']
3383,33046584,Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial.,"BACKGROUND


To increase vaccine acceptance, we created a Web-based the ""Vaccines and Your Baby"" intervention (VAYB) that provided new parents with vaccine information messages tailored to vaccine beliefs and values. We evaluated the effectiveness of the VAYB by comparing timely uptake of infant vaccines to an untailored version of the intervention (UT) or usual care intervention (UC) only.
METHODS


Between April 2016 and June 2019, we conducted a randomized clinical trial. Pregnant women and new parents were randomly assigned to the VAYB, UT, or UC arms. In the VAYB and UT arms, participants were exposed to interventions at 4 time points from pregnancy until their child was 15 months of age. The primary outcome was up-to-date status for recommended vaccines from birth to 200 days of age. A modified intent-to-treat analysis was conducted. Data were analyzed with logistic regression to generate odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS


We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up. The up-to-date rates in the VAYB, UT, and UC arms were 91.44%, 92.86%, and 92.31%, respectively. Infants in the VAYB arm were not more likely to be up to date than infants in the UC arm (OR = 0.89; 95% CI, 0.45-1.76) or in the UT arm (OR = 0.82; 95% CI, 0.42-1.63). The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
CONCLUSIONS


Delivering Web-based vaccine messages tailored to parents' vaccine attitudes and values did not positively impact the timely uptake of infant vaccines.",2020,"The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
","['Pregnant women and new parents', 'We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up', 'Between April 2016 and June 2019']","['Web-Based Tailored Messaging to Increase Vaccination', 'Delivering Web-based vaccine messages', 'intervention (UT) or usual care intervention (UC) only']",['up-to-date status'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",824.0,0.196029,"The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54-2.18).
","[{'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; jason.m.glanz@kp.org.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Kwan', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Adult and Child Consortium for Health Outcomes Research and Delivery Science and.'}]",Pediatrics,['10.1542/peds.2020-0669']
3384,33050760,A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years.,"OBJECTIVE


To evaluate the safety of peficitinib for the treatment of rheumatoid arthritis (RA) in Asian patients.
METHODS


Safety data from one Phase 2b, two Phase 3, and one open-label long-term extension study [data cut-off 31 May 2018] were pooled into Phase 3 studies (peficitinib 100 and 150 mg/day, and placebo) and Phase 2/3 studies (all peficitinib-treated patients). Incidence rates per 100 patient-years (PY) of adverse events (AEs) of special interest were calculated.
RESULTS


Overall, 1052 patients received peficitinib for 2336.3 PY of exposure (median 2.1 years); four deaths occurred, including one death after the studies. AE incidence was similar across peficitinib 100 and 150 mg/day groups (Phase 3 studies). Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer) (Phase 3 studies), and 0.1 (0.0, 0.3) for venous thromboembolism in all peficitinib-treated patients (Phase 2/3 studies).
CONCLUSION


Peficitinib was well tolerated in Asian patients with RA over a median of 2 years, with no observed dose or temporal dependency for AEs with prolonged administration.",2020,"Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer)","['Asian patients with rheumatoid arthritis treated over a median of 2 years', 'Asian patients with RA', 'Asian patients']","['peficitinib (ASP015K', 'placebo', 'peficitinib']","['Respective peficitinib and placebo incidence rates', 'AE incidence', 'Incidence rates', 'venous thromboembolism', 'tolerated']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C4505523', 'cui_str': 'ASP015K'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.140023,"Respective peficitinib and placebo incidence rates (95% confidence interval) per 100 PY were 2.9 (1.9, 4.6) and 0.0 for serious infections, 5.7 (4.2, 7.9) and 2.3 (0.6, 9.4) for herpes zoster-related disease, and 0.6 (0.2, 1.6) and 1.2 (0.2, 8.3) for malignancies (excluding non-melanoma skin cancer)","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Rokuda', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Izutsu', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Musashi', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kato', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1836789']
3385,33009186,Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial.,"BACKGROUND


Atelectasis occurs commonly during induction of general anaesthesia in children, particularly infants.
OBJECTIVES


We hypothesised that maintaining spontaneous ventilation can reduce atelectasis formation during anaesthetic induction in infants. We compared spontaneous ventilation and manual positive-pressure ventilation in terms of atelectasis formation in infants.
DESIGN


Randomised controlled study.
SETTING


Single tertiary hospital in Seoul, Republic of Korea, from November 2018 to December 2019.
PATIENTS


We enrolled 60 children younger than 1 year of age undergoing general anaesthesia, of whom 56 completed the study. Exclusion criteria were history of hypoxaemia during previous general anaesthesia, development of a respiratory tract infection within 1 month, current intubation or tracheostomy cannulation, need for rapid sequence intubation, preterm birth, age within 60 weeks of the postconceptional age and the presence of contraindications for rocuronium or sodium thiopental.
INTERVENTION


Patients were allocated randomly to either the 'spontaneous' group or 'controlled' group. During preoxygenation, spontaneous ventilation was maintained in the 'spontaneous' group while conventional bag-mask ventilation was provided in the 'controlled' group. After 5 min of preoxygenation, a lung ultrasound examination was performed to compare atelectasis formation in the two groups.
RESULTS


Atelectasis after preoxygenation was seen in seven (26.9%) of 26 patients in the 'spontaneous' group and 22 (73.3%) of 30 patients in the 'controlled' group (P = 0.001). The relative risk of atelectasis in the 'spontaneous' group was 0.39 (95% CI 0.211 to 0.723). Regarding ultrasound pictures of consolidation, the total score and sum of scores in the dependent regions were significantly lower in the 'spontaneous' group than in the 'controlled' group (P = 0.007 and 0.001, respectively).
CONCLUSION


Maintaining spontaneous ventilation during induction of general anaesthesia has a preventive effect against atelectasis in infants younger than 1 year of age, particularly in the dependent portions of the lungs.
TRIAL REGISTRATION


Clinicaltrials.gov (identifier: NCT03739697).",2020,"CONCLUSION


Maintaining spontaneous ventilation during induction of general anaesthesia has a preventive effect against atelectasis in infants younger than 1 year of age, particularly in the dependent portions of the lungs.
","['children, particularly infants', 'Single tertiary hospital in Seoul, Republic of Korea, from November 2018 to December 2019', '60 children younger than 1 year of age undergoing general anaesthesia, of whom 56 completed the study', 'infants younger than 1 year of age, particularly in the dependent portions of the lungs', 'Exclusion criteria were history of hypoxaemia during previous general anaesthesia, development of a respiratory tract infection within 1 month, current intubation or tracheostomy cannulation, need for rapid sequence intubation, preterm birth, age within 60 weeks of the postconceptional age and the presence of contraindications for', 'infants']","['conventional bag-mask ventilation', ""spontaneous' group or 'controlled' group"", 'spontaneous ventilation and manual positive-pressure ventilation', 'rocuronium or sodium thiopental', 'spontaneous breathing']","['relative risk of atelectasis', 'total score and sum of scores', 'atelectasis formation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C5200706', 'cui_str': 'Rapid Sequence Intubation'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",60.0,0.155551,"CONCLUSION


Maintaining spontaneous ventilation during induction of general anaesthesia has a preventive effect against atelectasis in infants younger than 1 year of age, particularly in the dependent portions of the lungs.
","[{'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital (S-HJ, HSJ, Y-EJ, E-HK, J-HL, J-TK, H-SK) and Department of Anaesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea (J-TK, H-SK).'}, {'ForeName': 'Hwan Suk', 'Initials': 'HS', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001327']
3386,33017045,"A split face randomized controlled trial comparing 1,064 nm Q-switched Nd-YAG laser and modified Kligman's formulation in patients with melasma in darker skin.","BACKGROUND


No randomized studies compared the efficacy and safety of modified Kligman's triple combination (TC) with 1,064 nm Q-switched Nd-YAG laser (QSNYL) in melasma in darker skin.
OBJECTIVES


To compare the efficacy and safety of QSNYL and TC in the treatment of melasma in Fitzpatrick skin types IV and V.
METHODS


In this split face randomized controlled trial, participants' cheeks were randomized to receive either weekly QSNYL (group A) or daily TC (group B) for 12 weeks, followed by 12 weeks of follow-up.
RESULTS


Twenty-eight patients completed the intervention, and 21 of them completed follow-up. We found a significant but modest reduction in mean melanin index, modified Melasma Area Severity Index (MASI), and photographic and patient's assessment in both modalities (P < 0.01). No significant differences were detected between the groups. All patients had reappearance of pigmentation by the end of follow-up. Adverse reactions were significantly more in group B (P < 0.001).
LIMITATION


The desired sample size could not be achieved.
CONCLUSION AND RELEVENCE


No statistically significant differences were observed between QSNYL and TC as monotherapy in melasma. Reappearance of melasma is inevitable after stopping treatment.",2020,"Adverse reactions were significantly more in group B (P < 0.001).
","[""participants' cheeks"", 'melasma in Fitzpatrick skin types', 'melasma in darker skin', 'patients with melasma in darker skin']","[""1,064\xa0nm Q-switched Nd-YAG laser and modified Kligman's formulation"", 'QSNYL and TC', 'daily TC', ""modified Kligman's triple combination (TC) with 1,064\xa0nm Q-switched Nd-YAG laser (QSNYL""]","['efficacy and safety', 'reappearance of pigmentation', 'Adverse reactions', ""mean melanin index, modified Melasma Area Severity Index (MASI), and photographic and patient's assessment in both modalities (P""]","[{'cui': 'C0007966', 'cui_str': 'Cheek structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.057856,"Adverse reactions were significantly more in group B (P < 0.001).
","[{'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Dev', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreenivas', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Sahni', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Bhari', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gomathy', 'Initials': 'G', 'LastName': 'Sethuraman', 'Affiliation': 'Department of Dermatology, All India Institute of Medical Sciences, New Delhi, India.'}]",International journal of dermatology,['10.1111/ijd.15229']
3387,33017169,A Hybrid Transtibial Technique Combines the Advantages of Anteromedial Portal and Transtibial Approaches: A Prospective Randomized Controlled Trial.,"BACKGROUND


The anteromedial (AM) portal and transtibial (TT) approaches are 2 common anterior cruciate ligament (ACL) femoral tunnel drilling techniques, each with unique benefits and disadvantages. A hybrid TT (HTT) technique using medial portal guidance of a flexible TT guide wire has recently been described that may combine the strengths of both the AM portal and the TT approaches.
HYPOTHESIS


The HTT technique will achieve anatomic femoral tunnel apertures similar to the AM portal technique, with improved femoral tunnel length and orientation.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 30 consecutive patients with primary ACL tears were randomized to undergo the TT, AM portal, or HTT technique for femoral tunnel positioning at the time of reconstruction. All patients underwent 3-dimensional computed tomography of the operative knee at 6 weeks postoperatively. Femoral and tibial tunnel aperture positions and tunnel lengths, as well as graft bending angles in the sagittal and coronal planes, were measured.
RESULTS


Tibial tunnel lengths and aperture positions were identical between the 3 groups. The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P  = .629) and depth ( P  = .582). By contrast, compared with the AM portal and HTT techniques, femoral apertures created with the TT technique were significantly higher ( P  < .001 and  P  < .001, respectively) and shallower ( P  = .014 and  P  = .022, respectively) in the notch. The mean femoral tunnel length varied significantly between the groups, measuring 35.2, 41.6, and 54.1 mm for the AM portal, HTT, and TT groups, respectively ( P  < .001). Last, there was no difference between the mean coronal ( P  = .190) and sagittal ( P  = .358) graft bending angles between the TT and HTT groups. By contrast, compared with the TT and HTT techniques, femoral tunnels created with the AM portal technique were significantly more angulated in the coronal plane (17.7° [ P  < .001] and 12.5° [ P  = .006], respectively) and sagittal plane (13.5° [ P  < .001] and 10.5° [ P  = .013], respectively).
CONCLUSION


This prospective randomized controlled trial found that the HTT technique achieved femoral aperture positions equally as anatomic as the AM portal technique but produced longer, less angulated femoral tunnels, which may help reduce graft strain and mismatch. As such, this hybrid approach may represent a beneficial combination of both the TT and the AM portal techniques.
REGISTRATION


NCT02795247 (ClinicalTrials.gov identifier).",2020,The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P  = .629) and depth ( P  = .582).,['30 consecutive patients with primary ACL tears'],"['3-dimensional computed tomography', 'TT, AM portal, or HTT technique for femoral tunnel positioning', 'hybrid TT (HTT) technique', 'Anteromedial Portal and Transtibial Approaches']","['mean coronal', 'femoral tunnels created with the AM portal technique', 'Tibial tunnel lengths and aperture positions', 'sagittal plane', 'coronal plane', 'mean femoral tunnel length', 'Femoral and tibial tunnel aperture positions and tunnel lengths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C3266783', 'cui_str': 'Length of wound tunneling'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}]",30.0,0.0466478,The AM portal and HTT techniques achieved identical femoral aperture positions in regard to both height ( P  = .629) and depth ( P  = .582).,"[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Trofa', 'Affiliation': 'Department of Orthopedics, NewYork-Presbyterian Hospital, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Bryan M', 'Initials': 'BM', 'LastName': 'Saltzman', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Corpus', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Connor', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Fleischli', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Piasecki', 'Affiliation': 'Sports Medicine Center, OrthoCarolina, Charlotte, North Carolina, USA.'}]",The American journal of sports medicine,['10.1177/0363546520956645']
3388,33021598,"Evaluation of Dried Amniotic Membrane on Wound Healing at Split-Thickness Skin Graft Donor Sites: A Randomized, Placebo-Controlled, Double-blind Trial.","OBJECTIVE


To evaluate the effect of amniotic membrane (AM) at split-thickness skin graft (STSG) donor sites.
METHODS


This double-blind randomized controlled trial was conducted on 35 eligible participants referred to the burn unit of Vasei Hospital of Sabzevar, Iran, during 2017 and 2018. Each STSG donor site was divided into two sides, and the respective halves were covered with either a dried AM or petrolatum gauze (control). Outcomes were evaluated on postprocedure days 10, 20, and 30 using the Vancouver Scar Scale.
RESULTS


The mean age of the patients was 39.4 ± 13.97 years, and 62.8% (n = 22) were male. There was no statistically significant difference in wound healing rate on day 10 (P = .261), 20 (P = .214), or 30 (P = .187) between groups. The intervention group had significantly better epithelialization than the control group on day 10 (investigator 1, 1.62 ± 0.59 vs 1.40 ± 0.88 [P = .009); investigator 2, 1.22 ± 0.84 vs 0.91 ± 0.85 [P = .003]), as well as pain reduction (P < .001 during the follow-up period). However, there was no statistically significant difference between groups in terms of pigmentation or vascularization (P > .05).
CONCLUSIONS


Findings suggest that the use of AM is not superior to petrolatum gauze in terms of STSG healing rate; however, AM achieved better pain reduction and epithelialization on day 10.",2020,"However, there was no statistically significant difference between groups in terms of pigmentation or vascularization (P > .05).
","['The mean age of the patients was 39.4 ± 13.97 years, and 62.8% (n = 22) were male', '35 eligible participants referred to the burn unit of Vasei Hospital of Sabzevar, Iran, during 2017 and 2018']","['amniotic membrane (AM) at split-thickness skin graft (STSG', 'dried AM or petrolatum gauze (control', 'Dried Amniotic Membrane', 'Placebo']","['pain reduction and epithelialization', 'epithelialization', 'wound healing rate', 'Wound Healing at Split-Thickness Skin', 'pigmentation or vascularization', 'pain reduction', 'Vancouver Scar Scale']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0006425', 'cui_str': 'Burns unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",35.0,0.15686,"However, there was no statistically significant difference between groups in terms of pigmentation or vascularization (P > .05).
","[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaheb', 'Affiliation': 'At the Sabzevar University of Medical Sciences in Iran, Mojtaba Vaheb, MD, is Plastic Surgery Specialist, Department of Dermatology; Bahareh Mohajer Kohestani, MD, is General Practitioner, Student Research Committee; Maryam Karrabi, MD, is Dermatologist, Department of Dermatology; Maryam Khosrojerdi, MSc, RN, is a nurse, Department of Nursing; Mahtab Khajeh, MD, is General Surgeon, Department of Surgery and Orthopedics; Ehsan Shahrestanaki, MSc, is Epidemiologist, Department of Biostatistics and Epidemiology; and Mohammad Sahebkar, MSc, is Epidemiologist, Department of Social Medicine. The authors have disclosed no financial relationships related to this article. Submitted February 9, 2020; accepted in revised form April 7, 2020.'}, {'ForeName': 'Bahareh Mohajer', 'Initials': 'BM', 'LastName': 'Kohestani', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karrabi', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Khosrojerdi', 'Affiliation': ''}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Khajeh', 'Affiliation': ''}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': ''}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': ''}]",Advances in skin & wound care,['10.1097/01.ASW.0000695752.52235.e3']
3389,33022148,Vocal music enhances memory and language recovery after stroke: pooled results from two RCTs.,"OBJECTIVE


Previous studies suggest that daily music listening can aid stroke recovery, but little is known about the stimulus-dependent and neural mechanisms driving this effect. Building on neuroimaging evidence that vocal music engages extensive and bilateral networks in the brain, we sought to determine if it would be more effective for enhancing cognitive and language recovery and neuroplasticity than instrumental music or speech after stroke.
METHODS


Using data pooled from two single-blind randomized controlled trials in stroke patients (N = 83), we compared the effects of daily listening to self-selected vocal music, instrumental music, and audiobooks during the first 3 poststroke months. Outcome measures comprised neuropsychological tests of verbal memory (primary outcome), language, and attention and a mood questionnaire performed at acute, 3-month, and 6-month stages and structural and functional MRI at acute and 6-month stages.
RESULTS


Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients. Voxel-based morphometry and resting-state and task-based fMRI results showed that vocal music listening selectively increased gray matter volume in left temporal areas and functional connectivity in the default mode network.
INTERPRETATION


Vocal music listening is an effective and easily applicable tool to support cognitive recovery after stroke as well as to enhance early language recovery in aphasia. The rehabilitative effects of vocal music are driven by both structural and functional plasticity changes in temporoparietal networks crucial for emotional processing, language, and memory.",2020,"RESULTS


Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients.","['after stroke', 'stroke patients (N\xa0=\xa083']","['Voxel-based morphometry and resting-state and task-based fMRI', 'vocal music listening', 'daily music listening', 'daily listening to self-selected vocal music, instrumental music, and audiobooks']","['gray matter volume in left temporal areas and functional connectivity', 'neuropsychological tests of verbal memory (primary outcome), language, and attention and a mood questionnaire performed at acute, 3-month, and 6-month stages and structural and functional MRI at acute and 6-month stages', 'Vocal music enhances memory and language recovery', 'verbal memory recovery']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.359863,"RESULTS


Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients.","[{'ForeName': 'Aleksi J', 'Initials': 'AJ', 'LastName': 'Sihvonen', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Leo', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ripollés', 'Affiliation': 'Department of Psychology, New York University, New York, New York.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Lehtovaara', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Ylönen', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Rajanaro', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Laitinen', 'Affiliation': 'Private Music Therapy Practitioner, Helsinki, Finland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Forsblom', 'Affiliation': 'Private Music Therapy Practitioner, Helsinki, Finland.'}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Saunavaara', 'Affiliation': 'Department of Medical Physics, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Autti', 'Affiliation': 'Department of Radiology, HUS Medical Imaging Center, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rodríguez-Fornells', 'Affiliation': ""Cognition and Brain Plasticity Group, Bellvitge Biomedical Research Institute, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Tervaniemi', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Soinila', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Särkämö', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51217']
3390,33026940,How to Choose the Right Treatment for Patients With Advanced Squamous Cell Carcinoma in the Absence of a Comparative Randomized Clinical Trial.,,2020,,['Patients With Advanced Squamous Cell Carcinoma'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]",[],[],,0.0406972,,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Stefano Kim, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France; Dewi Vernerey, PhD, INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, and Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France; and Christophe Borg, MD, Centre Hospitalier Universitaire de Besançon, Besançon; Clinical Investigational Center, CIC-1431, University Hospital of Besançon, Besançon; and INSERM, Unit 1098, University of Bourgogne Franche-Comté, Besançon, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02137']
3391,33027708,Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.,"Premature birth is a traumatic event that puts mother and child at risk for subsequent psychopathology. Skin-to-skin contact in the form of intermittent kangaroo mother care has been shown to positively affect the infant's stress response and cognitive development, but underlying mechanisms remain unclear. Moreover, first skin-to-skin contact is usually delayed for days after birth. In the delivery room skin-to-skin study (DR-SSC), a prospective randomized controlled trial conducted from 2/2012 to 7/2015, we set out to assess the effect of delivery room skin-to-skin contact on the infant's mRNA expression of six key molecules involved in stress response and neurobehavioral development at hospital discharge. 88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age) were included. In the delivery room after initial stabilization, infants were randomized to either 60 min of skin-to-skin or 5 min of visual contact with their mother. In this explorative add-on study on the original DR-SSC study, we determined the expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4) in peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks). Infants were followed up to six months corrected age. Relative mRNA expression of the corticotropin releasing hormone receptor 2 (CRH R2), the glucocorticoid receptor gene (NR3C1), and the serotonin transporter gene (SLC6A4) was significantly reduced in the delivery room SSC infants. Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age. Our results highlight the importance of delivery room mother-child skin-to-skin contact and underline the urgent need for in-depth studies on the underlying molecular mechanisms.",2020,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","['peripheral white blood cells of infants during routine blood sampling upon hospital discharge (corrected gestational age of 40 weeks', 'preterm infants', '88 firstborn, singleton preterm infants (born at 25-32 weeks of gestational age']","['delivery room skin-to-skin contact', '60 min of skin-to-skin or 5 min of visual contact with their mother']","['HPA axis reactivity and parameters of mother-child interaction', 'expression of six important stress response genes (CRHR1 and CRHR2, AVP, NR3C1, HTR2A, and SLC6A4']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0078039', 'cui_str': 'VAP combination'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C1456457', 'cui_str': 'SLC6A4 protein, human'}]",,0.0170859,"Additionally, gene expression of CRH R2 showed a correlation with HPA axis reactivity and parameters of mother-child interaction at six months corrected age.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hucklenbruch-Rother', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany. Electronic address: eva.rother@uni-koeln.de.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Vohlen', 'Affiliation': ""Metabolism and Perinatal Programming, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Mehdiani', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': ""Division of Neonatology, Children's Hospital, University of Cologne, Cologne, Germany.""}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104883']
3392,33027748,Renal protection with glucagon-like peptide-1 receptor agonists.,"There is an unmet need for renoprotective drugs for more pronounced reduction of albuminuria beyond that provided by renin-angiotensin system (RAS) blockers and for effective slowdown of eGFR decline independent of albuminuria. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have proven effective in reducing prespecified secondary composite kidney outcomes in cardiovascular outcome trials. However, GLP-1 RAs showed a prevailing anti-albuminuric effect, additional to that of RAS blockers, and a non-significant risk reduction in worsening of kidney function, at variance with sodium-glucose cotransporter 2 inhibitors. Mechanisms underlying renal protection with GLP-1 RAs are porly understood. Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results. Anti-inflammatory/anti-oxidant effects via intracellular signalling through protein kinase A, natriuretic effect via inhibition of sodium-hydrogen exchanger 3 and reduction of hyperfiltration have been proposed as direct renoprotective effects.",2020,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.",[],"['Glucagon-like peptide-1 receptor agonists (GLP-1 RAs', 'GLP-1 RAs', 'glucagon-like peptide-1 receptor agonists']","['glycaemic, blood pressure and body weight control']",[],"[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0545075,"Though treatment with GLP-1 RAs resulted in better glycaemic, blood pressure and body weight control versus placebo, correction for on-trial changes in these parameters did not significantly affect results.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Jonida', 'Initials': 'J', 'LastName': 'Haxhi', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Cirrito', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pugliese', 'Affiliation': 'Department of Clinical and Molecular Medicine, ""La Sapienza"" University, and Endocrine and Metabolic Unit, Sant\'Andrea University Hospital, Rome, Italy. Electronic address: giuseppe.pugliese@uniroma1.it.'}]",Current opinion in pharmacology,['10.1016/j.coph.2020.08.018']
3393,33028427,The effect of flaxseed on physical and mental fatigue in children and adolescents with overweight/obesity: a randomised controlled trial.,"Anti-inflammatory agents such as long-chain n-3 fatty acids have been recognised to improve disease-related fatigue. We hypothesised that α-linolenic acid may also benefit in reduction of fatigue in low-grade inflammation such as overweight/obesity. Seventy-two healthy children and adolescents with BMI > 25 kg/m2 were randomised to flaxseed (n 38) and puffed wheat (n 34) groups. Participants consumed isoenergetic amounts of either 20 g/d flaxseed or 25 g/d puffed wheat for 4 weeks. Fatigue, mood feelings (depression, anxiety and stress), appetite, energy intake, weight, height and waist circumference were measured. Analysis was performed based on per-protocol and intention-to-treat (ITT) approaches. Consumption of flaxseed decreased mental fatigue and caused a significant between-group difference (P < 0·001). Although no significant change in physical and total score of fatigue was observed in either group, a significant between-group difference occurred due to a more remarkable change in these parameters in the flaxseed group. General fatigue, motivation, activity and mood feelings did not change significantly between groups. Flaxseed showed less benefit than puffed wheat on anthropometric measures as it caused a smaller increase in height (0·53 (sd 0·89) v. 1·09 (sd 0·87) cm, P = 0·03) and reduction in BMI (-0·25 (sd 0·63) v. -0·67 (sd 0·56) kg/m2, P = 0·01) than puffed wheat. Appetite and waist circumference decreased in both groups, but no significant difference was observed between groups. In ITT analysis, only alteration in mental fatigue was significant. In conclusion, consumption of flaxseed may improve mental fatigue in children with overweight/obesity. However, because of smaller increase in height, it is better to hinder administration of flaxseed during periods of growth.",2020,Consumption of flaxseed decreased mental fatigue and caused a significant between-group difference (P<0.001).,"['Seventy two healthy children and adolescents with body mass index (BMI) >25 kg/m2 were randomized to flaxseed (n=38) and puffed wheat (n=34) groups', 'children with overweight/obesity', 'children and adolescents with overweight/obesity']","['flaxseed', 'α-linolenic acid']","['BMI', 'mental fatigue', 'height', 'Appetite and waist circumference', 'Fatigue, mood feelings (depression, anxiety, and stress), appetite, energy intake, weight, height, and waist circumference', 'physical and total score of fatigue', 'physical and mental fatigue', 'General fatigue, motivation, activity, and mood feelings']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",72.0,0.0455585,Consumption of flaxseed decreased mental fatigue and caused a significant between-group difference (P<0.001).,"[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Gholami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Fars, 7153675541, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Akhlaghi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Fars, 7153675541, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520003888']
3394,33032806,[Comparison of post-operative nausea and vomiting with intravenous versus inhalational anesthesia in laparotomic abdominal surgery: a randomized clinical trial].,"BACKGROUND


Postoperative Nausea and Vomiting (PONV) is a multifactorial surgical complication with an unclear underlying cause. Anesthetic methods, patients' characteristics and the type of surgery are considered as factors affecting PONV. This study was designed to compare the effect of inhalational and intravenous anesthesia in abdominal surgery on the incidence and severity of PONV.
METHODS


A single-blinded prospective randomized clinical trial on 105 patients aged 18-65 years was carried out. Patients were divided in two groups of Total Intravenous Anesthesia (TIVA) and Inhalational anesthesia. The incidence and severity of PONV were examined at 0, 2, 6, 12, and 24hours after the surgery. The use of a rescue antiemetic was also evaluated.
RESULTS


Fifty point nine percent of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p <0.001). The incidence of vomiting was reported in 11.3% of the Inhalational group and 3.8% of the TIVA group (p=0.15), and 24.5% of patients in the Inhalation group and 9.6% of patients in the intravenous group needed an antiemetic medication (p=0.043).
CONCLUSION


The incidence of postoperative nausea and vomiting and the need for administration of an antiemetic rescue drug, and the severity of nausea in patients were significantly lower in the TIVA group.",2020,Fifty point nine percent of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p <0.001).,"['105\xa0patients aged 18-65\xa0years', 'laparotomic abdominal surgery']","['inhalational and intravenous anesthesia', 'inhalational anesthesia', 'Total Intravenous Anesthesia (TIVA) and Inhalational anesthesia']","['antiemetic medication', 'postoperative nausea and vomiting', 'PONV', 'incidence and severity of PONV', 'severity of nausea', 'incidence of vomiting']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0002920', 'cui_str': 'Intravenous anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]","[{'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0806419,Fifty point nine percent of the patients in the inhalation group and 17.3% of the patients in the intravenous group developed PONV (p <0.001).,"[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ahmadzadeh Amiri', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomini Hospital Complex, Tehran, Irã.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Karvandian', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Department of Anesthesiology, Tehran, Irã. Electronic address: karvandian@tums.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ashouri', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Department of General Surgery, Tehran, Irã.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomeini Hospital Complex, Department of Anesthesiology, Tehran, Irã.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahmadzadeh Amiri', 'Affiliation': 'Tehran University of Medical Sciences, Imam Khomini Hospital Complex, Tehran, Irã.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.04.019']
3395,33010934,"[Effect of palonosetron, ondansetron and dexamethasone in the prevention of postoperative nausea and vomiting in video cholecystectomy with total venous anesthesia with propofol-remifentanil - randomized clinical trial].","INTRODUCTION AND OBJECTIVES


The incidence of Postoperative Nausea and Vomiting (PONV) after video cholecystectomy is high. Progress in pharmacological PONV prophylaxis includes a new generation of 5-HT 3  antagonists. This study aims to assess the effect of the 5-HT 3  antagonist in postanesthetic antiemetic management of patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia.
METHODS


Sixty individuals who underwent video cholecystectomy were randomized into three groups of 20 individuals according to the treatment administered: 0.125 mg of palonosetron (Group 1); 4 mg of ondansetron associated with 4 mg of dexamethasone (Group 2); 4 mg of dexamethasone (Group 3). General intravenous anesthesia was performed with propofol, remifentanil and rocuronium. The group to which the participant belonged was concealed from the investigator who assessed drug effect. PONV was assessed using the Rhodes Scale at 12 and 24 hours after surgery. Rescue medication was 0.655 to 1.5 mg of droperidol.
RESULTS


Group 1 presented a lower incidence of PONV and required less rescue medication in the first postoperative hour. There was no significant difference among the three groups regarding PONV incidence in the first 12 postoperative hours. Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours. Group 1 showed significantly superior nausea control in the first 12 postoperative hours.
CONCLUSIONS


The present study showed evidence that palonosetron is superior to the drugs compared regarding a protracted antiemetic effect and less requirement of rescue drugs, mainly related to its ability to completely inhibit the uncomfortable symptom of nausea.",2020,"Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours.","['patients submitted to laparoscopic cholecystectomy with total intravenous anesthesia', 'video cholecystectomy with total venous anesthesia with', 'Sixty individuals who underwent']","['droperidol', 'ondansetron associated with 4\xa0mg of dexamethasone', 'propofol-remifentanil', 'video cholecystectomy', 'palonosetron', 'dexamethasone', 'propofol, remifentanil and rocuronium', '5-HT 3  antagonist', 'palonosetron, ondansetron and dexamethasone']","['PONV incidence', 'postoperative nausea and vomiting', 'PONV', 'Postoperative Nausea and Vomiting (PONV', 'superior nausea control', 'incidence of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0013136', 'cui_str': 'Droperidol'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C1700654', 'cui_str': 'HTR3A protein, human'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.0368543,"Groups 1 and 2 were superior to Group 3 regarding the control of PONV from 12 to 24 hours, and after rescue medication from 12 to 24 hours.","[{'ForeName': 'Neuber Martins', 'Initials': 'NM', 'LastName': 'Fonseca', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Faculdade de Medicina, Disciplina de Anestesiologia, Uberlândia, MG, Brasil; Sociedade Brasileira de Anestesiologia (SBA), Comissão de Normas Técnicas, Brasil; CET-FMUF, Uberlândia, MG, Brasil; Coordinator of CE\xa026.06001 - Equipamento Respiratório e de Anestesia da ABNT and Delegate of ABNT no ISO/TC 121 - Anaesthetic and Respiratory Equipment, Uberlândia, MG, Brasil. Electronic address: neubermf@gmail.com.'}, {'ForeName': 'Ludmila Ribeiro', 'Initials': 'LR', 'LastName': 'Pedrosa', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Uberlândia, MG, Brasil.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Melo', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Curso de Medicina, Uberlândia, MG, Brasil.'}, {'ForeName': 'Ricardo de Ávila', 'Initials': 'RÁ', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal de Uberlândia (UFU), Curso de Medicina, Departamento de Cirurgia, Disciplina de Cirurgia Vascular, Uberlândia, MG, Brasil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.08.001']
3396,33012517,Cerebral blood flow alterations associated with high volume caudal block in infants.,"BACKGROUND


High-volume (1.5 ml kg -1 ) caudal block in infants results in major reductions of cerebral blood flow velocity (CBFV) and cerebral oxygenation, caused by rostral CSF movement which increases intracranial pressure. The primary aim of this study was to determine the relationship between injected volume and CBFV changes. We hypothesised that this volume-blood flow relationship would have a similar albeit inverted shape to the well-known intracranial pressure volume-pressure curve.
METHODS


Fifteen subjects, age 0-6 months, mean (range) weight 4.9 (2.1-6.4) kg, were studied. A 1.5 ml kg -1  caudal injection of 0.2% ropivacaine was administered in three phases separated by two pauses. Subjects were randomised into five groups, in whom the pauses were implemented at different pre-set proportions of the total injected volume. Middle cerebral artery Doppler ultrasonography was used for CBFV measurements (V max , peak CBF velocity; V min , lowest CBF velocity; velocity time index). Mean flow velocity, pulsatility index, and resistivity index were calculated, and haemodynamic parameters were recorded.
RESULTS


CBFV parameters decreased in all patients. The most affected parameter, V min , was reduced by ∼50% (range 15-68%) compared with baseline. There was a nonlinear relationship between the volume of the first phase injection and the CBFV measurement during the first pause. Across all time points, there was a linear relationship between volume administered and CBFV. Systemic haemodynamic parameters remained stable throughout the study.
CONCLUSIONS


Injection pauses appear to attenuate adverse CBFV increases during administration of a high-volume caudal block.",2020,"The most affected parameter, V min , was reduced by ∼50% (range 15-68%) compared with baseline.","['Fifteen subjects, age 0-6 months, mean (range) weight 4.9 (2.1-6.4) kg, were studied', 'infants']",['ropivacaine'],"['Systemic haemodynamic parameters', 'CBFV measurements (V max , peak CBF velocity; V min , lowest CBF velocity; velocity time index', 'cerebral blood flow velocity (CBFV) and cerebral oxygenation', 'Mean flow velocity, pulsatility index, and resistivity index', 'adverse CBFV', 'CBFV parameters', 'Cerebral blood flow alterations']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}]",,0.0538609,"The most affected parameter, V min , was reduced by ∼50% (range 15-68%) compared with baseline.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Castillo', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden. Electronic address: paul.castillo@sll.se.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Lundblad', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Forestier', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Eksborg', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Women and Child Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per-Arne', 'Initials': 'PA', 'LastName': 'Lönnqvist', 'Affiliation': 'Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital Stockholm, Sweden; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.055']
3397,33019861,Goal-Oriented Attention Self-Regulation Training Improves Executive Functioning in Veterans with Post-Traumatic Stress Disorder and Mild Traumatic Brain Injury.,"Difficulties in executive-control functions are common sequelae of both traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). The goal of this study was to assess whether a cognitive rehabilitation training that was applied successfully in civilian and military TBI would be effective for military Veterans with comorbid PTSD and mild TBI (mTBI). In the previous study, Veterans with a history of mild to severe TBI improved significantly after goal-oriented attentional self-regulation (GOALS) training on measures of attention/executive function, functional task performance, and emotional regulation. The objective of this study was to assess effects of GOALS training in Veterans with comorbid PTSD and mTBI. Forty Veterans with a current PTSD diagnosis and history of mTBI (6+ months post) were randomized to either five weeks of GOALS or Brain-Health Education (BHE) training matched in time and intensity. Evaluator-blinded assessments at baseline and post-training included neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation. After GOALS but not BHE training, participants significantly improved from baseline on primary outcome measures of: overall complex attention/executive function neuropsychological performance composite ( F  = 12.35,  p  = 0.001; Cohen d = 0.48), and overall mood disturbance -POMS emotional regulation self-report (F = 4.29,  p  = 0.05, Cohen d = 0.41). In addition, GOALS but not BHE participants indicated a significant decrease in PTSD symptoms (PCL-M Total Score) (F = 4.80,  p  = 0.05, Cohen d = 0.60), and demonstrated improvement on complex functional task performance-GPS Learning and Memory (F = 5.06,  p  = 0.05, Cohen d = 0.56]. Training in attentional self-regulation applied to participant-defined goals may improve cognitive functioning in Veterans with comorbid PTSD and mTBI. Improving cognitive control functioning may also improve functioning in other domains such as emotional regulation and functional performance, potentially making it particularly relevant for Veterans with a history of mTBI and comorbid psychiatric symptoms.",2020,"After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41].","['military Veterans with comorbid PTSD and mild TBI (mTBI', 'Forty Veterans with current PTSD diagnosis and history of mTBI (6+ months post', 'Veterans with PTSD and Mild TBI', 'Veterans with comorbid PTSD and mTBI', 'Veterans with history of mTBI and co-morbid psychiatric symptoms']","['GOALS training', 'Goal-Oriented Attention Self-Regulation Training', 'cognitive rehabilitation training', 'Attentional Self-Regulation (GOALS) training', 'GOALS or Brain-Health Education (BHE) training']","['Overall Complex Attention/Executive Function neuropsychological performance composite', 'complex functional task performance -GPS Learning and Memory', 'cognitive functioning', 'attention/executive function, functional task performance, and emotional regulation', 'Overall Mood Disturbance -POMS emotional regulation self-report', 'neuropsychological and complex functional task performance, and self-report measures of emotional functioning/regulation', 'PTSD symptoms (PCL-M Total Score', 'Executive Functioning']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0438524,"After GOALS, but not BHE training, participants significantly improved from baseline on primary outcome measures of: Overall Complex Attention/Executive Function neuropsychological performance composite [F = 12.35, p =.001; Cohen's d = .48], and Overall Mood Disturbance -POMS emotional regulation self-report [F=4.29, p=.05, Cohen's d = .41].","[{'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Novakovic-Agopian', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Lainie', 'Initials': 'L', 'LastName': 'Posecion', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Kornblith', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Abrams', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Burciaga', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Carlin', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Groberio', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Maruyama', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Anthony J W', 'Initials': 'AJW', 'LastName': 'Chen', 'Affiliation': 'University of California, San Francisco, San Francisco, California, USA.'}]",Journal of neurotrauma,['10.1089/neu.2019.6806']
3398,33020898,Transdermal Testosterone Attenuates Drug-Induced Lengthening of Both Early and Late Ventricular Repolarization in Older Men.,"We have previously reported that transdermal testosterone attenuates drug-induced QT interval lengthening in older men. However, it is unknown whether this is due to modulation of early ventricular repolarization, late repolarization, or both. In a secondary analysis of a prospective, randomized, double-blind, placebo-controlled three-way crossover study, we determined if transdermal testosterone and oral progesterone attenuate drug-induced lengthening of early and late ventricular repolarization, represented by the electrocardiographic measurements J-T peak  c and T peak  -T end  , respectively, as well as T peak  -T end  /QT, a measure of transmural dispersion of repolarization. Male volunteers ≥ 65 years of age (n = 14) were randomized to receive transdermal testosterone 100 mg, oral progesterone 400 mg, or matching transdermal/oral placebo daily for 7 days. On the morning following the seventh day, subjects received intravenous ibutilide 0.003 mg/kg, after which electrocardiograms were performed serially. One subject was excluded due to difficulty in T-wave interpretation. Pre-ibutilide J-T peak  c was lower during the testosterone phase than during progesterone and placebo (216 ± 23 vs. 227 ± 28 vs. 227 ± 21 ms, P = 0.002). Maximum post-ibutilide J-T peak  c was also lower during the testosterone phase (233 ± 22 vs. 246 ± 29 vs. 248 ± 23 ms, P < 0.0001). Pre-ibutilide T peak  -T end  was not significantly different during the three phases, but maximum post-ibutilide T peak  -T end  was lower during the testosterone phase (80 ± 12 vs. 89 ± 18 vs. 86 ± 15 ms, P = 0.002). Maximum T peak  -T end  /QT was also lower during the testosterone phase (0.199 ± 0.023 vs. 0.216 ± 0.035 vs. 0.209 ± 0.031, P = 0.005). Progesterone exerted minimal effect on drug-induced lengthening of J-T peak  c, and no effect on T peak  -T end  or T peak  -T end  /QT. Transdermal testosterone attenuates drug-induced lengthening of both early and late ventricular repolarization in older men.",2020,"Progesterone exerted minimal effect on drug-induced lengthening of J-T peak  c, and no effect on T peak  -T end  or T peak  -T end  /QT.","['Male volunteers ≥ 65 years of age (n=14', 'Older Men', 'older men']","['progesterone and placebo', 'transdermal testosterone 100 mg, oral progesterone 400 mg, or matching transdermal/oral placebo', 'T end', 'QT', 'transdermal testosterone and oral progesterone', 'Progesterone', 'placebo', 'Pre-ibutilide J-T peak', 'intravenous ibutilide', 'Transdermal testosterone', 'Transdermal Testosterone', 'Maximum post-ibutilide J-T peak', 'transdermal testosterone']","['lengthening of early and late ventricular repolarization', 'electrocardiographic measurements J-T peak  c and T peak  -T end  , respectively, as well as T peak  -T end', 'lengthening of both early and late ventricular repolarization', 'QT', 'Pre-ibutilide T peak  -T end', 'transmural dispersion of repolarization', 'Maximum T peak']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C1125815', 'cui_str': 'Testosterone 100 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0082966', 'cui_str': 'ibutilide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0392744', 'cui_str': 'Lengthened'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0082966', 'cui_str': 'ibutilide'}, {'cui': 'C0522497', 'cui_str': 'Transmural'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.263145,"Progesterone exerted minimal effect on drug-induced lengthening of J-T peak  c, and no effect on T peak  -T end  or T peak  -T end  /QT.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tomaselli Muensterman', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jaynes', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Sowinski', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Overholser', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'The Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Tisdale', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, Indiana, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2072']
3399,33017328,Impact of Training Based on Orem's Theory on Self-Care Agency and Quality of Life in Patients With Coronary Artery Disease.,"BACKGROUND


Coronary artery disease (CAD) is a primary cause of death worldwide. CAD negatively affects individuals because it reduces their functional skills and self-care abilities and disrupts quality of life.
PURPOSE


This study was designed to assess the impact of a training program based on Orem's self-care deficit nursing theory (SCDNT) on self-care abilities and quality of life in patients with CAD.
METHODS


This study was conducted using a randomized, controlled, pretest/posttest experimental design. One hundred two patients with CAD were divided evenly into either the intervention or control group, with sample randomization based on gender, age, low-density lipoprotein cholesterol level, and Self-Care Agency Scale scores. For both groups, interviews were conducted in two sessions held, respectively, at the hospital and at home. Study data were collected using the patient information form, Self-Care Agency Scale, MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew), Quality of Life Questionnaire (15D), and training booklet.
RESULTS


A highly significant difference was found between the two groups in terms of the average posttest scores on the Self-Care Agency Scale, MacNew, and 15D. For the intervention group, the posttest scores on the Self-Care Agency Scale, MacNew, and 15D were significantly higher than the pretest scores, whereas average pretest and posttest scores on these measures were similar for the control group.
CONCLUSIONS


The training program developed in this study based on Orem's SCDNT improved self-care agency as well as disease-specific and overall quality of life in patients with CAD. Nurses should pay attention to the CAD-related educational level of patients when teaching them how to live with their disease. Moreover, nurses should use Orem's SCDNT to strengthen the self-care agency of these patients to increase quality of life and the effectiveness of related education efforts. Finally, medical institutions and governments should develop appropriate education policies for patients at risk of CAD and for those with CAD.",2020,"A highly significant difference was found between the two groups in terms of the average posttest scores on the Self-Care Agency Scale, MacNew, and 15D. For the intervention group, the posttest scores on the Self-Care Agency Scale, MacNew, and 15D were significantly higher than the pretest scores, whereas average pretest and posttest scores on these measures were similar for the control group.
","['Patients With Coronary Artery Disease', 'One hundred two patients with CAD', 'patients with CAD', 'patients at risk of CAD and for those with CAD']","[""training program based on Orem's self-care deficit nursing theory (SCDNT""]","['density lipoprotein cholesterol level, and Self-Care Agency Scale scores', 'functional skills and self-care abilities and disrupts quality of life', 'Self-Care Agency Scale, MacNew, and 15D', 'Self-Care Agency Scale, MacNew Heart Disease Health-Related Quality of Life Questionnaire (MacNew), Quality of Life Questionnaire (15D), and training booklet', 'Self-Care Agency and Quality of Life', 'self-care abilities and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231369', 'cui_str': 'Total self-care deficit'}, {'cui': 'C0028700', 'cui_str': 'Theory, Nursing'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]",102.0,0.0233579,"A highly significant difference was found between the two groups in terms of the average posttest scores on the Self-Care Agency Scale, MacNew, and 15D. For the intervention group, the posttest scores on the Self-Care Agency Scale, MacNew, and 15D were significantly higher than the pretest scores, whereas average pretest and posttest scores on these measures were similar for the control group.
","[{'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Tok Yildiz', 'Affiliation': 'PhD, RN, Assistant Professor, Program of Anaesthesia, Department of Medical Services and Techniques, Vocational School of Health Services, Sivas Cumhuriyet University, Sivas, Turkey.'}, {'ForeName': 'Mağfiret', 'Initials': 'M', 'LastName': 'KaŞikÇi', 'Affiliation': 'PhD, RN, Professor, Faculty of Nursing, Atatürk University, Erzurum, Turkey.'}]",The journal of nursing research : JNR,['10.1097/JNR.0000000000000406']
3400,33017580,Ultra-low-dose quadruple combination blood pressure-lowering therapy in patients with hypertension: The QUARTET randomized controlled trial protocol.,"High blood pressure is the leading cause of preventable morbidity and mortality globally. Many patients remain on single-drug treatment with poor control, although guidelines recognize that most require combination therapy for blood pressure control. Our hypothesis is that a single-pill combination of 4 blood pressure-lowering agents each at a quarter dose may provide a simple, safe, and effective blood pressure-lowering solution which may also improve long-term adherence. The Quadruple UltrA-low-dose tReaTment for hypErTension (QUARTET) double-blind, active-controlled, randomized clinical trial will examine whether ultra-low-dose quadruple combination therapy is more effective than guideline-recommended standard care in lowering blood pressure. QUARTET will enroll 650 participants with high blood pressure either on no treatment or on monotherapy. Participants will be randomized 1:1 and allocated to intervention therapy of a single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg or to control therapy of a single identical-appearing pill containing irbesartan 150 mg. In both arms, step-up therapy of open-label amlodipine 5 mg will be provided if blood pressure is >140/90 at 6 weeks. The primary outcome is the difference between groups in the change from baseline in mean unattended automated office systolic blood pressure at 12-week follow-up. The primary outcome and some secondary outcomes will be assessed at 12 weeks; there is an optional 12-month extension phase to assess longer-term efficacy and tolerability. Our secondary aims are to assess if this approach is safe, has fewer adverse effects, and has better tolerability compared to standard care control. QUARTET will therefore provide evidence for the effectiveness and safety of a new paradigm in the management of high blood pressure.",2020,"Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control.","['650 participants with high blood pressure, either on no treatment or on monotherapy', 'patients with hypertension']","['single pill (quadpill) containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg or to control therapy of a single identical appearing pill containing irbesartan 150 mg', 'Ultra-low-dose quadruple combination blood pressure lowering therapy', 'open-label amlodipine', 'ultra-low-dose quadruple combination therapy']","['mean unattended automated office systolic blood pressure', 'optional 12months extension phase to assess longer term efficacy and tolerability']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C4517467', 'cui_str': '0.625'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",650.0,0.288783,"Our secondary aims are to assess if this approach is safe, has fewer adverse effects and better tolerability compared to standard care control.","[{'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, UNSW, Sydney, NSW, Australia. Electronic address: Clara.chow@sydney.edu.au.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Atkins', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Graham S', 'Initials': 'GS', 'LastName': 'Hillis', 'Affiliation': 'Department of Cardiology, Royal Perth Hospital and University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hay', 'Affiliation': 'Castle Hill Medical Centre, Sydney, NSW, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schlaich', 'Affiliation': 'Dobney Hypertension Centre, School of Medicine, University of Western Australia and Royal Perth Hospital, Perth, Western Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Webster', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW, Australia; Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The Westmead Applied Research Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; The George Institute for Global Health, UNSW, Sydney, NSW, Australia.'}]",American heart journal,['10.1016/j.ahj.2020.09.017']
3401,33021688,Near-focus magnification and second-generation narrow-band imaging for early gastric cancer in a randomized trial.,"BACKGROUND


Magnifying endoscopy with narrow-band imaging (NBI) is effective for the diagnosis of early gastric cancer (EGC). However, magnifying endoscopy is not yet popular globally because of the required level of skill and lack of availability. To overcome these problems, dual-focus endoscopy (standard- and near-focus (NF) modes) has been developed. In this study, we evaluated the diagnostic performance of NF with second-generation (2G)-NBI (NF-NBI) for the diagnosis of EGC.
METHODS


This was a secondary analysis of a multicenter randomized controlled trial of 4523 high-risk patients who underwent gastroscopies at 13 institutions in Japan. Patients were randomly assigned to white-light imaging (WLI) followed by 2G-NBI or to 2G-NBI followed by WLI. Lesions suspicious for EGC, newly detected by non-magnifying WLI or 2G-NBI, were subsequently observed with NF-NBI. All detected lesions were biopsied or resected. The diagnostic performance of NF-NBI was compared with the final histology.
RESULTS


A total of 870 detected lesions (145 EGC, 725 non-EGC) were analyzed. Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%. There were no significant differences in diagnostic performance between lesions detected by WLI or 2G-NBI. For lesions diagnosed with high (333 lesions) and low (537 lesions) confidences, accuracy was 92.2% and 84.9%, sensitivity was 64.7% and 58.5%, and specificity was 90.5% and 88.8%, respectively.
CONCLUSION


The diagnostic performance of NF-NBI is good and acceptable for diagnosis of EGC in combination with either WLI or 2G-NBI.",2020,"Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%.","['A total of 870 detected lesions (145 EGC, 725 non-EGC', '4523 high-risk patients who underwent gastroscopies at 13 institutions in Japan']","['Near-focus magnification and second-generation narrow-band imaging', 'white-light imaging (WLI) followed by 2G-NBI or to 2G-NBI followed by WLI', 'Magnifying endoscopy with narrow-band imaging (NBI', 'NF with second-generation (2G)-NBI (NF-NBI']","['Overall diagnostic performance', 'sensitivity', 'diagnostic performance of NF-NBI', 'diagnostic performance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}]",4523.0,0.160259,"Overall diagnostic performance for EGC using NF-NBI was accuracy 87.7%, sensitivity 60.7%, specificity 93.1%, positive predictive value 63.8%, and negative predictive value 92.2%.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kakushima', 'Affiliation': 'Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Shizuoka, Suntougun, 411-8777, Japan. n.kakushima@gmail.com.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Doyama', 'Affiliation': 'Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Horimatsu', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Noriya', 'Initials': 'N', 'LastName': 'Uedo', 'Affiliation': 'Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Kanzaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Department of Endoscopy, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Oda', 'Affiliation': 'Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Department of Advanced Medicine Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Chizu', 'Initials': 'C', 'LastName': 'Yokoi', 'Affiliation': 'Endoscopy Division, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Biostatistics, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Muto', 'Affiliation': 'Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-020-01734-3']
3402,33026307,Flashing in-curb LEDs and beacons at unsignalized crosswalks and driver's visual attention to pedestrians during nighttime.,"Driver's visual attention (eye movements) and driving behaviour (kinematic data) were assessed when approaching an experimental crosswalk that included flashing white in-curb LED strips, flashing orange beacons, backlit 'Yield here to pedestrians' vertical signs, and enhanced lighting when a staged pedestrian attempted to cross. An experimental condition in which all devices were active was compared with a control condition in which only enhanced lighting and backlit vertical signs were active. The results showed a significant increase of motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements in the experimental condition. The introduction of flashing in-curb LED strips and flashing orange beacons proved to be very effective in increasing the night-time safety of the pedestrian crossing.  Practitioner summary:  The study investigated the effects of flashing in-curb LED strips and beacons on driver's visual attention (eye movements) and speed when approaching a crosswalk during night-time. The results showed that the combination of these flashing devices significantly increased yielding compliance and the distance of pedestrian detection.  Abbreviations:  ANOVA: analysis of variance; EU: European Union; HAWK: high intensity activated crosswalk system; LED: light-emitting diode; PHB: pedestrian hybrid beacons; ROI: region of interest; RRFB: rectangular rapid flashing beacons; UK: United Kingdom; US: United States.",2020,"The results showed a significant increase of motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements in the experimental condition.",[],[],"[""driver's visual attention (eye movements"", ""motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements"", 'yielding compliance and the distance of pedestrian detection', ""Driver's visual attention (eye movements) and driving behavior (kinematic data""]",[],[],"[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0450063', 'cui_str': 'Pedestrian'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.02562,"The results showed a significant increase of motorists' yielding compliance, distance of first fixation to the pedestrian area, standard deviation for horizontal eye movements in the experimental condition.","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lantieri', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'Environmental Psychology Lab, Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vignali', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ennia Mariapaola', 'Initials': 'EM', 'LastName': 'Acerra', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Pierclaudio', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': 'Environmental Psychology Lab, Department of Psychology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Simone', 'Affiliation': 'Department of Civil, Chemical, Environmental and Material Engineering, University of Bologna, Bologna, Italy.'}]",Ergonomics,['10.1080/00140139.2020.1834149']
3403,33028082,"Left Ventricular Enlargement, Cardiac Resynchronization Therapy Efficacy, and Impact of MultiPoint Pacing.","BACKGROUND


Left ventricular (LV) epicardial pacing results in slowly propagating paced wavefronts. We postulated that this effect might limit cardiac resynchronization therapy efficacy in patients with LV enlargement using conventional biventricular pacing with single-site LV pacing, but be mitigated by LV stimulation from 2 widely spaced sites using MultiPoint pacing with wide anatomic separation (MPP-AS: ≥30 mm). We tested this hypothesis in the multicenter randomized MPP investigational device exemption trial.
METHODS


Following implant, quadripolar biventricular single-site pacing was activated in all patients (n=506). From 3 to 9 months postimplant, among patients with available baseline LV end-diastolic volume (LVEDV) measures, 188 received biventricular single-site pacing and 43 received MPP-AS. Patients were dichotomized by median baseline LVEDV indexed to height (LVEDVI Median ). Outcomes were measured by the clinical composite score (primary efficacy end point), quality of life, LV structural remodeling (↑EF >5% and ↓ESV 10%) and heart failure event/cardiovascular death.
RESULTS


LVEDVI Median  was 1.1 mL/cm. Baseline characteristics differed in patients with LVEDVI >Median  versus LVEDVI ≤Median . Among patients with LVEDVI >Median , biventricular single-site pacing was less efficacious compared to patients with LVEDVI ≤Median  (clinical composite score, 65% versus 79%). In contrast, MPP-AS programming generated greater clinical composite score response (92% versus 65%,  P =0.023) and improved quality of life (-31.0±29.7 versus -15.7±22.1,  P =0.038) versus biventricular single-site pacing in patients with LVEDVI >Median . Reverse remodeling trended better with MPP-AS programming. In patients with LVEDVI >Median , heart failure event rate increased following the 3-month randomization point with biventricular single-site pacing (0.0150±0.1725 in LVEDVI >Median versus  -0.0190±0.0808 in LVEDVI  ≤Median ,  P =0.012), but no heart failure event occurred in patients with MPP-AS programming between 3 and 9 months in LVEDVI >Median . All measured outcomes did not differ in patients receiving MPP-AS and biventricular single-site pacing with LVEDVI ≤Median .
CONCLUSIONS


Conventional biventricular single-site pacing, even with a quadripolar lead, has reduced efficacy in patients with LV enlargement. However, the greatest response rate in patients with larger hearts was observed when programmed to MPP-AS pacing.",2020,"In contrast, MPP-AS programming generated greater CCS response (92% vs. 65%, p=0.023) and improved QOL (-31.0±29.7 vs. -15.7±22.1, p=0.038) vs. BiV in patients with LVEDVI >Median .","['patients with LV enlargement using', 'patients with LV enlargement']","['  - Left ventricular (LV) epicardial pacing', 'Methods  - Following implant, quadripolar BiV pacing', 'limit cardiac resynchronization therapy (CRT', 'conventional biventricular (BiV) pacing with single-site LV pacing']","['LVEDVI >Median , HF event rate', 'clinical composite score (CCS, primary efficacy endpoint), quality of life (QOL), LV structural remodeling (↑EF>5% and ↓ESV 10%) and heart failure (HF) event/ cardiovascular death', 'Left Ventricular Enlargement, CRT Response and Impact of MultiPoint Pacing', 'QOL', 'CCS response', 'response rate', 'heart failure event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0397434', 'cui_str': 'Insertion of epicardial electrode for temporary cardiac pacing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0079031', 'cui_str': 'Bovine immunodeficiency virus'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]",,0.0515493,"In contrast, MPP-AS programming generated greater CCS response (92% vs. 65%, p=0.023) and improved QOL (-31.0±29.7 vs. -15.7±22.1, p=0.038) vs. BiV in patients with LVEDVI >Median .","[{'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Varma', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH (N.V.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Saint Thomas Research Institute, Nashville, TN (J.B.).'}, {'ForeName': 'Gery', 'Initials': 'G', 'LastName': 'Tomassoni', 'Affiliation': 'Baptist Health Lexington, KY (G.T.).'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Love', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD (C.J.L.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA (D.M.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sheppard', 'Affiliation': 'The Heart Institute, St. Petersburg, FL (R.S.).'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Niazi', 'Affiliation': 'Aurora Cardiovascular Services, Milwaukee, WI (I.N.).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cranke', 'Affiliation': 'Abbott, Plano, TX (G.C., K.L.).'}, {'ForeName': 'Kwangdeok', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Abbott, Plano, TX (G.C., K.L.).'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Corbisiero', 'Affiliation': 'Deborah Heart and Lung, Browns Mills, NJ (R.C.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008680']
3404,33028649,Healthy ageing among older Aboriginal people: the Ironbark study protocol for a cluster randomised controlled trial.,"INTRODUCTION


Older Aboriginal people have a strong leadership role in their community including passing on knowledge and teachings around culture and connections to Country. Falls significantly affect older people and are a growing concern for older Aboriginal people and their families. Regular participation in balance and strength exercise has been shown to be efficacious in reducing falls. A pilot study developed in partnership with Aboriginal communities, the Ironbark: Standing Strong and Tall programme, demonstrated high community acceptability and feasibility, and gains in balance and strength in Aboriginal participants. This cluster randomised controlled trial will assess the effectiveness of the programme in reducing the rate of falls in older Aboriginal people.
METHODS


We will examine the effectiveness and cost-effectiveness of the Ironbark group-based fall prevention programme compared with a group-based social programme, with Aboriginal people aged 45 years and older in three Australian states. The primary outcome is fall rates over 12 months, measured using weekly self-reported data. Secondary outcomes measured at baseline and after 12 months include quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity. Differences between study groups in the primary and secondary outcomes at 12 months will be estimated.
CONCLUSION


This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years. The study has strong cultural and community governance, including Aboriginal investigators and staff, and is guided by a steering committee that includes representatives of Aboriginal community-controlled services.
TRIAL REGISTRATION NUMBER


ACTRN12619000349145.",2020,This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years.,"['Aboriginal people aged 45 years and older in three Australian states', 'Healthy ageing among older Aboriginal people', 'Aboriginal peoples aged ≥45 years', 'Aboriginal participants', 'older Aboriginal people', 'partnership with Aboriginal communities, the Ironbark']","['Ironbark group-based fall prevention programme', 'fall prevention programme', 'Standing Strong and Tall programme']","['community acceptability and feasibility, and gains in balance and strength', 'effectiveness and cost-effectiveness', 'fall rates over 12 months, measured using weekly self-reported data', 'quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}]",,0.119015,This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ivers', 'Affiliation': 'School of Population Health, University of New South Wales, Sydney, New South Wales, Australia rebecca.ivers@unsw.edu.au.'}, {'ForeName': 'Julieann', 'Initials': 'J', 'LastName': 'Coombes', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Sydney, Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Mackean', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Sydney, Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Clemson', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Ryder', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Macniven', 'Affiliation': 'School of Population Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Clapham', 'Affiliation': 'Ngarruwan Ngadju First Peoples Health and Wellbeing Research Centre, Australian Health Services Research Institute, The University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2020-043915']
3405,33029896,Clinical comparison of an electric-powered ionic toothbrush and a manual toothbrush in plaque reduction: A randomized clinical trial.,"OBJECTIVES


This study aimed to evaluate the plaque removal efficacy of a newly developed electric-powered ionic toothbrush vs. a manual toothbrush.
MATERIALS AND METHODS


Manual or electric-powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I). After 2 min of brushing, all tooth surfaces were stained with a plaque staining solution, and blinded examiners performed scoring using the Rustogi Modification of the Navy Plaque Index. Plaque removal rate was calculated at the central incisors, first premolar and first molar, as representative teeth, in the maxilla and mandibula. One week following Phase I, the same examinations were repeated in all subjects using another toothbrush (Phase II), as a crossover design.
RESULTS


Electric ionic toothbrushes demonstrated a significantly higher plaque removal rate than manual toothbrushes in the premolar and molar areas (p < .05). However, in the central incisor area, no statistically significant difference was observed.
CONCLUSIONS


Compared with manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.",2020,"Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.",['Manual or electric-powered ionic toothbrushes were randomly assigned to 30 healthy volunteers divided into two groups (Phase I'],"['electric-powered ionic toothbrush', 'newly-developed electric-powered ionic toothbrush vs. a manual toothbrush']","['plaque removal efficacy', 'plaque removal rate', 'Plaque removal rate']","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.0143584,"Compared to manual toothbrushes, electric-powered ionic ones were significantly efficient in removing plaque in the premolar and molar areas.","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ikawa', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Mizutani', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Sudo', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kano', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Akizuki', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Izumi', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Iwata', 'Affiliation': 'Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",International journal of dental hygiene,['10.1111/idh.12475']
3406,33033800,Tadalafil may improve cerebral perfusion in small-vessel occlusion stroke-a pilot study.,"New treatments for cerebral small-vessel disease are needed to reduce the risk of small-vessel occlusion stroke and vascular cognitive impairment. We investigated an approach targeted to the signalling molecule cyclic guanosine monophosphate, using the phosphodiesterase 5 inhibitor tadalafil, to explore if it improves cerebral blood flow and endothelial function in patients with cerebral small-vessel disease and stroke. In a randomized, double-blinded, placebo-controlled, cross-over pilot trial (NCT02801032), we included patients who had a previous (>6 months) small-vessel occlusion stroke. They received a single dose of either 20 mg tadalafil or placebo on 2 separate days at least 1 week apart. We measured the following: baseline MRI for lesion load, repeated measurements of blood flow velocity in the middle cerebral artery by transcranial Doppler, blood oxygen saturation in the cortical microvasculature by near-infrared spectroscopy, peripheral endothelial response by EndoPAT and endothelial-specific blood biomarkers. Twenty patients with cerebral small-vessel disease stroke (3 women, 17 men), mean age 67.1 ± 9.6, were included. The baseline mean values ± standard deviations were as follows: blood flow velocity in the middle cerebral artery, 57.4 ± 10.8 cm/s; blood oxygen saturation in the cortical microvasculature, 67.0 ± 8.2%; systolic blood pressure, 145.8 ± 19.5 mmHg; and diastolic blood pressure, 81.3 ± 9.1 mmHg. We found that tadalafil significantly increased blood oxygen saturation in the cortical microvasculature at 180 min post-administration with a mean difference of 1.57 ± 3.02%. However, we saw no significant differences in transcranial Doppler measurements over time. Tadalafil had no effects on peripheral endothelial function assessed by EndoPAT and endothelial biomarker results conflicted. Our findings suggest that tadalafil may improve vascular parameters in patients with cerebral small-vessel disease stroke, although the effect size was small. Increased oxygenation of cerebral microvasculature during tadalafil treatment indicated improved perfusion in the cerebral microvasculature, theoretically presenting an attractive new therapeutic target in cerebral small-vessel disease. Future studies of the effect of long-term tadalafil treatment on cerebrovascular reactivity and endothelial function are needed to evaluate general microvascular changes and effects in cerebral small-vessel disease and stroke.",2020,We found that tadalafil significantly increased blood oxygen saturation in the cortical microvasculature at 180 min post-administration with a mean difference of 1.57 ± 3.02%.,"['Twenty patients with cerebral small-vessel disease stroke (3 women, 17 men), mean age 67.1\u2009±\u20099.6, were included', 'patients with cerebral small-vessel disease stroke', 'patients with cerebral small-vessel disease and stroke', 'patients who had a previous (>6\u2009months) small-vessel occlusion stroke']","['placebo', 'tadalafil or placebo', 'Tadalafil', 'tadalafil']","['peripheral endothelial function', 'transcranial Doppler measurements', 'blood oxygen saturation', 'vascular parameters', 'cerebral blood flow and endothelial function', 'blood flow velocity', 'cerebrovascular reactivity and endothelial function', 'Increased oxygenation of cerebral microvasculature', 'systolic blood pressure', 'diastolic blood pressure', 'cerebral perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0243079', 'cui_str': 'microvasculature'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",20.0,0.437187,We found that tadalafil significantly increased blood oxygen saturation in the cortical microvasculature at 180 min post-administration with a mean difference of 1.57 ± 3.02%.,"[{'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Ölmestig', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}, {'ForeName': 'Ida R', 'Initials': 'IR', 'LastName': 'Marlet', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}, {'ForeName': 'Rasmus H', 'Initials': 'RH', 'LastName': 'Hansen', 'Affiliation': 'Department of Radiology, Herlev Gentofte Hospital, Herlev 2730, Denmark.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Rehman', 'Affiliation': 'Department of Radiology, Herlev Gentofte Hospital, Herlev 2730, Denmark.'}, {'ForeName': 'Rikke Steen', 'Initials': 'RS', 'LastName': 'Krawcyk', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}, {'ForeName': 'Egill', 'Initials': 'E', 'LastName': 'Rostrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research, Mental Health Center Glostrup, Capital Region Psychiatry, Glostrup 2600, Denmark.'}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Lambertsen', 'Affiliation': 'Department of Neurobiology Research, Institute of Molecular Medicine, University of Southern Denmark, Odense 5000, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kruuse', 'Affiliation': 'Department of Neurology, Neurovascular Research Unit, Herlev Gentofte Hospital, University of Copenhagen, Herlev 2730, Denmark.'}]",Brain communications,['10.1093/braincomms/fcaa020']
3407,33033844,Evaluation of a new face mask concept for oxygen administration: a crossover study in healthy volunteers.,"We developed a new face mask concept for oxygen administration using non-woven textiles. The aim of this study was to evaluate whether the new mask improves acceptability without compromising O 2  delivery and CO 2  elimination. 10 healthy adult volunteers were randomized to either the conventional plastic face mask-first group or the new face mask-first group. Participants were asked to wear the assigned mask with O 2  at 3 L/min for 10 min while seated. End tidal O 2  concentration (et-O 2 ) and end tidal CO 2  concentration (et-CO 2 ) were measured via a sampling tube located at the mouth. After a 10-min rest period, the other mask was tested in the same manner. Mask discomfort was evaluated using a 100 mm visual analog scale (VAS) where 0, comfortable and 100, uncomfortable. The results showed that use of the new mask caused less discomfort than the conventional mask (new, 11; conventional, 33) (P = 0.002). Median et-O 2  with the new mask was 33%, compared with 30% with the conventional mask (P = 0.008). There were no significant differences in et-CO 2  by mask type (new, 32 mmHg; conventional, 30 mmHg). In conclusion, the new mask was more comfortable and provided higher et-O 2  than the conventional mask.",2020,"There were no significant differences in et-CO 2  by mask type (new, 32 mmHg; conventional, 30 mmHg).","['10 healthy adult volunteers', 'healthy volunteers']",['conventional plastic face mask-first group or the new face mask-first group'],"['End tidal O 2  concentration (et-O 2 ) and end tidal CO 2  concentration (et-CO 2 ', 'discomfort', 'Mask discomfort']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]",10.0,0.0231405,"There were no significant differences in et-CO 2  by mask type (new, 32 mmHg; conventional, 30 mmHg).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. kondo320@hiroshima-u.ac.jp.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Saeki', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Otsuki', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Yasuo M', 'Initials': 'YM', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02861-0']
3408,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE


Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN


A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING


52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP


304 US-trained practicing anesthesiologists.
INTERVENTIONS


The absence or presence of the EM during the simulation case.
MEASUREMENTS


Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS


Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS


Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
3409,33032163,"Recovery using ""float"" from high intensity stress on growth hormone-like molecules in resistance trained men.","OBJECTIVE


The purpose of this study was to examine the influence of a novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST) on growth hormone responses to an intense resistance exercise stress.
DESIGN


Nine resistance trained men (age: 23.4 ± 2.5 yrs.; height: 175.3 ± 5.4 cm; body mass: 85.3 ± 7.9 kg) completed a balanced, crossover-controlled study design with two identical exercise trials, differing only in post-exercise recovery intervention (i.e., control or floatation-REST). A two-week washout period was used between experimental conditions. Plasma lactate was measured pre-exercise, immediately post-exercise and after the 1 h. recovery interventions. Plasma iGH was measured pre-exercise, immediately-post exercise, and after the recovery intervention, as well as 24 h and 48 h after the exercise test. The bGH-L was measured only at pre-exercise and following each recovery intervention.
RESULTS


For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (~14 mmol • L-1) and remained slightly elevated after the recovery condition. The same pattern of responses was observed for iGH with no differences from resting values at 24 and 48 h of recovery. The bGH-L showed no exercise-induced changes following recovery with either treatment condition, however concentration values were dramatically lower than ever reported.
CONCLUSION


The use of floatation-REST therapy immediately following intense resistance exercise does not appear to influence anterior pituitary function in highly resistance trained men. However, the lower values of bGH suggest dramatically different molecular processing mechanisms at work in this highly trained population.",2020,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","['Nine resistance trained men (age: 23.4\u202f±\u202f2.5\u202fyrs', '14', ' height: 175.3\u202f±\u202f5.4\u202fcm; body mass: 85.3\u202f±\u202f7.9\u202fkg', 'highly resistance trained men', 'resistance trained men']","['novel ""floatation-restricted environmental stimulation therapy"" (floatation-REST', 'floatation-REST therapy', 'exercise recovery intervention (i.e., control or floatation-REST']","['Plasma iGH', 'bGH-L', 'Plasma lactate', 'lactate concentrations', 'concentration values']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017351', 'cui_str': 'Immunoglobulin gene GM allotype'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",9.0,0.0688166,"For both experimental conditions, a significant (P ≤ 0.05) increase in lactate concentrations were observed immediately post-exercise (","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kraemer', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America. Electronic address: kraemer.44@osu.edu.'}, {'ForeName': 'Lydia K', 'Initials': 'LK', 'LastName': 'Caldwell', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Post', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Beeler', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Dickerson', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kennett', 'Affiliation': 'Department of Veterinary and Biomedical Sciences, The Pennsylvania State University, University Park, PA 16802, United States of America.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Volek', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Maresh', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH 43210, United States of America.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Hymer', 'Affiliation': 'Department of Biochemistry and Molecular Biology, The Pennsylvania State University, University Park, PA 16802, United States of America.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101355']
3410,33032164,"Exploring the impact of a liquefied petroleum gas intervention on time use in rural Peru: A mixed methods study on perceptions, use, and implications of time savings.","BACKGROUND


Efforts to promote clean cooking through adoption of clean-burning fuels such as liquefied petroleum gas (LPG) are often based on the idea that near-exclusive use of LPG could lead to health improvements. However, benefits beyond health, such as time savings, could be more tangible and meaningful to LPG users.
OBJECTIVES


This study investigated the effect of an LPG intervention on time spent cooking and collecting fuel, using objective measures of stove temperatures combined with self-reports under conditions of near-exclusive LPG use. We also investigated the perceived value of any time savings and potential economic and quality of life implications.
METHODS


We analyzed data from the Cardiopulmonary outcomes and Household Air Pollution trial in Puno, Peru, a randomized controlled trial with 180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention. Surveys conducted with 90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed time spent cooking and collecting biomass fuel and use of time savings. Cooking time was objectively measured with temperature sensors on all stoves. Qualitative interviews explored perceptions and use of time savings in more depth.
RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day. Participants perceived time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields.
DISCUSSION


This paper suggests that the benefits of LPG extend beyond health and the environment. LPG use could also lead to economic and quality of life gains, through increased time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection.",2020,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","['180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention', '90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed', 'rural Peru']","['LPG', 'liquefied petroleum gas intervention', 'LPG intervention']","['time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection', 'time spent cooking and collecting biomass fuel and use of time savings', 'time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields', 'Cooking time', 'time savings and potential economic and quality of life implications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",180.0,0.0503954,"RESULTS


Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kendra.williams@jhu.edu.'}, {'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Harvey', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.105932']
3411,33032168,COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development.,"BACKGROUND


Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite endpoint (COPDCompEx) that could predict treatment effect on exacerbations, enabling the design of shorter early phase clinical trials requiring fewer patients.
METHODS


In this post hoc analysis, data from 20 randomized controlled trials were used to develop and test COPDCompEx. Diary events were tested against predefined threshold values for peak expiratory flow, reliever medication use, and symptoms. A COPDCompEx event was defined as first occurrence of a diary event, a moderate or severe exacerbation, or a study dropout. Ratios of event frequency, treatment effect and future trial sample size were compared between COPDCompEx and moderate and severe exacerbations.
FINDINGS


At 3 months, the proportion of patients experiencing COPDCompEx events increased over 3-fold versus exacerbations alone. All components contributed to COPDCompEx event rate. Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
INTERPRETATION


COPDCompEx may be used to predict treatment effect on moderate and severe exacerbations of chronic obstructive pulmonary disease. This may enable the design of shorter Phase 2 clinical trials requiring fewer patients when compared with current exacerbation studies, with exacerbations as a key Phase 3 endpoint. This would, therefore, allow more efficient decision-making with reduced burden and risk to study participants.",2020,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
",['moderate and severe chronic obstructive pulmonary disease exacerbations'],['COPDCompEx'],"['peak expiratory flow, reliever medication use, and symptoms', 'proportion of patients experiencing COPDCompEx events']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.362478,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
","[{'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Marburg, Germany, Member of the German Center for Lung Research (DZL).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fuhlbrigge', 'Affiliation': 'Pulmonary Sciences and Critical Care, Department of Medicine, University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jauhiainen', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Lieke E J M', 'Initials': 'LEJM', 'LastName': 'Scheepers', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Sethi', 'Affiliation': 'Emeritus Professor Respiratory Medicine, Kings College, London, UK; Galecto Biotech, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Locantore', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tal-Singer', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rennard', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Cambridge, UK.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Da Silva', 'Affiliation': 'AstraZeneca, Early Respiratory & Immunology (R&I) Clinical Development, BioPharmaceuticals R&D, Gothenburg, Sweden. Electronic address: Carla.DaSilva@astrazeneca.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106175']
3412,33037961,Assessment of the Effectiveness of Group Cognitive Behavioural Therapy in Reducing Pathological Gambling.,"Pathological gambling is a developmental disorder usually associated with a continuous loss of control over gambling; it also involves a preoccupation with gambling and with obtaining money for the same purpose of gambling, irrational thinking, and a continuation of the behaviour despite being aware of its adverse consequences. This study examined the effectiveness of group cognitive-behavioural therapy (GCBT) on pathological gambling among Nigerian students. The study used a group randomised controlled trial design to assign participants to intervention and control groups. A total of 40 undergraduate students, aged 18-30, were classified as pathological gamblers (participants) in this study. Participants completed self-report scales titled South oaks gambling screen and Gambling Symptom Assessment Scale at three-time points. The intervention lasted for 8 weeks. The data collected were statistically analysed using repeated-measures ANOVA. Results revealed that GCBT has a significant effect in decreasing the symptoms of pathological gambling among the participants in GCBT compared to those in the control group and that the improvements were maintained at follow-up. The study concluded that group cognitive-behavioural therapy is impactful therapy in reducing pathological gambling among students. It has also validated the effectiveness of cognitive-behavioural therapy in altering erroneous thoughts and replacing it with a better alternative realistic way of thinking.",2020,Results revealed that GCBT has a significant effect in decreasing the symptoms of pathological gambling among the participants in GCBT compared to those in the control group and that the improvements were maintained at follow-up.,"['40 undergraduate students, aged 18-30, were classified as pathological gamblers (participants) in this study', 'pathological gambling among students', 'pathological gambling among Nigerian students']","['cognitive-behavioural therapy', 'GCBT', 'group cognitive-behavioural therapy (GCBT', 'Group Cognitive Behavioural Therapy']","['self-report scales titled South oaks gambling screen and Gambling Symptom Assessment Scale', 'Pathological Gambling', 'symptoms of pathological gambling']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030662', 'cui_str': 'Compulsive gambling'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0030662', 'cui_str': 'Compulsive gambling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.0246291,Results revealed that GCBT has a significant effect in decreasing the symptoms of pathological gambling among the participants in GCBT compared to those in the control group and that the improvements were maintained at follow-up.,"[{'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria. moses.ede@unn.edu.ng.'}, {'ForeName': 'Joachim C', 'Initials': 'JC', 'LastName': 'Omeje', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Damian Chijioke', 'Initials': 'DC', 'LastName': 'Ncheke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria. chijioke.ncheke@unn.edu.ng.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Agah', 'Affiliation': 'Department of Science Education, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Ngozi H', 'Initials': 'NH', 'LastName': 'Chinweuba', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Chijioke Virgilus', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}]",Journal of gambling studies,['10.1007/s10899-020-09981-y']
3413,33038066,A high salt meal does not impair cerebrovascular reactivity in healthy young adults.,"A high sodium (Na +  ) meal impairs peripheral vascular function. In rodents, chronic high dietary Na +  impairs cerebral vascular function, and in humans, habitual high dietary Na +  is associated with increased stroke risk. However, the effects of acute high dietary Na +  on the cerebral vasculature in humans are unknown. The purpose of this study was to determine if acute high dietary Na +  impairs cerebrovascular reactivity in healthy adults. Thirty-seven participants (20F/17M; 25 ± 5 years; blood pressure [BP]: 107 ± 9/61 ± 6 mm Hg) participated in this randomized, cross-over study. Participants were given a low Na +  meal (LSM; 138 mg Na +  ) and a high Na +  meal (HSM; 1,495 mg Na +  ) separated by ≥ one week. Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ) were measured pre- (baseline) and 60 min post-prandial. Cerebrovascular reactivity was assessed by determining the percent change in middle cerebral artery velocity to hypercapnia (via 8% CO 2  , 21% oxygen, balance nitrogen) and hypocapnia (via mild hyperventilation). Peripheral vascular function was measured using brachial artery flow-mediated dilation (FMD). Changes in serum Na +  were greater following the HSM (HSM: Δ1.6 ± 1.2 mmol/L vs. LSM: Δ0.7 ± 1.2 mmol/L, p < .01). Cerebrovascular reactivity to hypercapnia (meal effect: p = .41) and to hypocapnia (meal effect: p = .65) were not affected by the HSM. Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74). These data suggest that a single high Na +  meal does not acutely impair cerebrovascular reactivity, and suggests that despite prior findings, a single high Na +  meal does not impair peripheral vascular function in healthy adults.",2020,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","['healthy young adults', 'Thirty-seven participants (20F/17M; 25\xa0±\xa05\xa0years; blood pressure [BP]: 107\xa0±\xa09/61\xa0±\xa06\xa0mm\xa0Hg', 'healthy adults']","['high Na +  meal (HSM; 1,495\xa0mg Na +  ) separated by\xa0≥\xa0one week', 'sodium (Na +  ) meal', 'dietary Na ', 'low Na +  meal (LSM; 138']","['Serum Na +  , beat-to-beat BP, middle cerebral artery velocity (transcranial Doppler), and end-tidal carbon dioxide (P ET  CO 2  ', 'Cerebrovascular reactivity to hypercapnia', 'Peripheral vascular function', 'brachial artery flow-mediated dilation (FMD', 'middle cerebral artery velocity to hypercapnia', 'cerebrovascular reactivity', 'Cerebrovascular reactivity', 'Changes in serum Na ', 'peripheral vascular function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",37.0,0.0392972,"Contrary with previous findings, FMD was not reduced following the HSM (meal effect: p = .74).","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Serrador', 'Affiliation': 'Department of Pharmacology, Physiology & Neuroscience, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology & Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14585']
3414,33038505,The design of a randomized controlled trial to evaluate multi-dimensional effects of a section 1115 Medicaid demonstration waiver with community engagement requirements.,"Section 1115 demonstration waivers provide a mechanism for states to implement changes to their Medicaid programs. While such waivers are mandated to include evaluations of their impact, randomization - the gold standard for assessing causality - has not typically been a consideration. In a critical departure, the Commonwealth of Kentucky opted to pursue a two-arm randomized controlled trial (RCT) for their controversial 2018 Medicaid Demonstration waiver, which included work requirements as a condition for the subset of beneficiaries deemed able-bodied to maintain eligibility for benefits. Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program. To address potential bias from differential attrition from the Medicaid program that would accrue from solely analyzing administrative data, our team designed a rich, prospective, longitudinal survey to collect primary and secondary outcomes from six categories of interest to policymakers: insurance coverage, health care utilization and quality, health behaviors, socioeconomic measures, personal finances, and health outcomes. At baseline, a subset of survey participants was invited to participate in the collection of biometric samples via in-person follow-up visits, and a cross-section were also invited to participate in qualitative interviews. While the demonstration waiver was terminated before the program began, our study design illustrates that it is possible for other researchers and state agencies seeking to evaluate Medicaid demonstration waivers and other demonstration policies to work together to implement high quality randomized trials - even for controversial policies.",2020,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,['section 1115 Medicaid demonstration waiver with community engagement requirements'],['control group who would retain their current benefits as part of the existing Medicaid expansion program'],[],"[{'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0281739,Beneficiaries were randomized 9:1 to the new waiver program or a control group who would retain their current benefits as part of the existing Medicaid expansion program.,"[{'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Underhill', 'Affiliation': 'Columbia Law School, New York, NY, USA; Department of Population and Family Health, Mailman School of Public Heath, Columbia University, New York, NY, USA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Dixon', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ferrell', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Margrethe E', 'Initials': 'ME', 'LastName': 'Montgomery', 'Affiliation': 'National Opinion Research Center at the University of Chicago, Bethesda MD and Chicago, IL, USA.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Center for Health Equity Research and Promotion, Cresencz VA Medical Center, Philadelphia, USA.'}, {'ForeName': 'Atheendar S', 'Initials': 'AS', 'LastName': 'Venkataramani', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 423 Guardian Dr, Philadelphia, PA 19104, USA. Electronic address: atheenv@pennmedicine.upenn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106173']
3415,33038950,"Effect on mortality of increasing the cutoff blood glucose concentration for initiating hypoglycaemia treatment in severely sick children aged 1 month to 5 years in Malawi (SugarFACT): a pragmatic, randomised controlled trial.","BACKGROUND


Low blood glucose concentrations are common in sick children who present to hospital in low-resource settings and are associated with increased mortality. The cutoff blood glucose concentration for the diagnosis and treatment of hypoglycaemia currently recommended by WHO (2·5 mmol/L) is not evidence-based. We aimed to assess whether increasing the cutoff blood glucose concentration for hypoglycaemia treatment in severely ill children at presentation to hospital improves mortality outcomes.
METHODS


We did a pragmatic, randomised controlled trial at two referral hospitals in Malawi. Severely ill children aged 1 month to 5 years presenting to the emergency department with a capillary blood glucose concentration of between 2·5 mmol/L (3·0 mmol/L in severely malnourished children) and 5·0 mmol/L were randomly assigned (1:1) by a computer-generated randomisation sequence, stratified by study site and severe malnutrition, to receive either an immediate intravenous bolus of 10% dextrose at 5 mL/kg followed by a 24-h maintenance infusion of 10% dextrose at 100 mL/kg for the first 10 kg of bodyweight, 50 mL/kg for the next 10 kg, and 20 mL/kg for each subsequent kg of bodyweight (intervention group) or observation for a minimum of 60 min and standard care (control group). Participants and study personnel were not masked to treatment allocation. The primary outcome was all-cause in-hospital mortality, assessed on an intention-to-treat basis. Safety was also assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02989675.
FINDINGS


Between Dec 5, 2016, and Jan 22, 2019, 10 947 children were screened, of whom 332 were randomly assigned, and 322 were included in the final analysis (n=162 in the control group and n=160 in the intervention group). The study was terminated after an interim analysis at 24% enrolment indicated futility. The median age of participants was 2·3 years (IQR 1·4-3·2), 65 (45%) were female, and the baseline characteristics of participants were similar between the two groups. The number of in-hospital deaths from any cause was 26 (16%) in the control group and 24 (15%) in the intervention group, with an absolute mortality difference of 1·0% (95% CI -6·9 to 9·0). Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
INTERPRETATION


Increasing the cutoff blood glucose concentration for hypoglycaemia treatment in severely sick children in Malawi from 2·5 mmol/L to 5·0 mmol/L did not reduce all-cause in-hospital mortality. Our findings do not support changing the cutoff for dextrose administration, and further research on the optimal management of severely ill children who present to the emergency department with low blood glucose concentrations is warranted.
FUNDING


Swedish Research Council and Stockholm Country Council.",2020,"Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
","['Severely ill children aged 1 month to 5 years presenting to the emergency department with a capillary blood glucose concentration of between 2·5 mmol/L (3·0 mmol/L in severely malnourished children) and 5·0 mmol/L', 'sick children', 'severely sick children', 'two referral hospitals in Malawi', 'Between Dec 5, 2016, and Jan 22, 2019, 10\u2008947 children were screened, of whom 332 were randomly assigned, and 322 were included in the final analysis (n=162 in the control group and n=160 in the intervention group', 'severely ill children', 'severely sick children aged 1 month to 5 years in Malawi (SugarFACT']","['bodyweight (intervention group) or observation for a minimum of 60 min and standard care (control group', 'immediate intravenous bolus of 10% dextrose at 5 mL/kg followed by a 24-h maintenance infusion of 10% dextrose']","['Safety', 'number of in-hospital deaths', 'cutoff blood glucose concentration', 'cause in-hospital mortality, assessed on an intention-to-treat basis', 'mortality of increasing the cutoff blood glucose concentration', 'Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]",10947.0,0.295853,"Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden; Department of Anaesthesia and Intensive Care, Queen Elizabeth Central Hospital, Blantyre, Malawi; Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi; Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: tim.baker@ki.se.'}, {'ForeName': 'Fatsani', 'Initials': 'F', 'LastName': 'Ngwalangwa', 'Affiliation': 'Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Henderson', 'Initials': 'H', 'LastName': 'Masanjala', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Queen', 'Initials': 'Q', 'LastName': 'Dube', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Langton', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi; Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hildenwall', 'Affiliation': ""Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden; Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi; Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}]",The Lancet. Global health,['10.1016/S2214-109X(20)30388-0']
3416,33045374,A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment.,"BACKGROUND


Most clinical trials of contrast-rebalanced binocular amblyopia treatment used a contrast increment protocol of 10% daily with successful play. Paired with a definition of success requiring only 15-30 min/day of gameplay, this increment protocol could allow children to reach 100% fellow eye contrast in 3-9 hours; however, this may not provide adequate therapeutic time with reduced fellow eye contrast. The purpose of this study was to compare the original protocol against three alternative contrast increment protocols designed to increase the number of treatment hours.
METHODS


In this prospective study, 63 amblyopic children (4-10 years; amblyopic eye visual acuity, 20/40-125) were randomly assigned one of four daily contrast increment protocols for 4 weeks, all starting with 20% fellow eye contrast: 10%, 5%, 0%, or 10% for first 4 weeks then reset to 20% and repeat 10% increment for the final 4 weeks. Children played contrast-rebalanced games for 1 hour/day, 5 days/week. Best-corrected visual acuity, stereoacuity, and suppression were assessed at baseline and every 2 weeks until the 8-week outcome visit.
RESULTS


At baseline, mean amblyopic eye best-corrected visual acuity was 0.47 ± 0.14 logMAR (20/60), improving overall 0.14 ± 0.08 logMAR (1.4 lines; P < 0.0001) at 8 weeks. All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002). Stereoacuity and suppression also improved (all Ps < 0.05).
CONCLUSIONS


None of the new protocols resulted in less improvement than the original 10% contrast increment protocol. Contrast-rebalanced binocular games yielded significant improvements in visual acuity, stereoacuity, and suppression with or without daily contrast increments.",2020,All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002).,"['63 amblyopic children (4-10 years; amblyopic eye visual acuity, 20/40-125']",[],"['Stereoacuity and suppression', 'visual acuity', 'visual acuity, stereoacuity, and suppression with or without daily contrast increments', 'mean amblyopic eye best-corrected visual acuity', 'Best-corrected visual acuity, stereoacuity, and suppression']","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C4319551', 'cui_str': '125'}]",[],"[{'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",63.0,0.15286,All four protocols resulted in similar improvement in visual acuity (0.13-0.16 logMAR; all Ps < 0.0002).,"[{'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas. Electronic address: reedjost@retinafoundation.org.'}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Kelly', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hunter', 'Affiliation': 'Heaton Eye Associates, Tyler, Texas.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Stager', 'Affiliation': 'Pediatric Ophthalmology & Adult Strabismus, Plano, Texas.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Luu', 'Affiliation': 'Pediatric Ophthalmology & Adult Strabismus, Plano, Texas.'}, {'ForeName': 'Joel N', 'Initials': 'JN', 'LastName': 'Leffler', 'Affiliation': ""Children's Eye Care of North Texas, Plano, Texas.""}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Dao', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, Dallas, Texas.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Beauchamp', 'Affiliation': 'ABC Eyes Pediatric Ophthalmology, Dallas, Texas.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas; University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.06.009']
3417,33064412,Exercise Training Improves Microvascular Function in Burn Injury Survivors.,"INTRODUCTION


Vasodilator function is impaired in individuals with well-healed burn injuries; however, therapeutic interventions that lessen or reverse this maladaptation are lacking. The purpose of this study was to test the hypothesis that a 6-month community-based exercise training program would increase microvascular dilator function in individuals with well-healed burn injuries, irrespective of the magnitude of the injured body surface area. Further, we hypothesize that macrovascular dilator function would remain unchanged posttraining.
METHODS


Microvascular function (forearm reactive hyperemia), macrovascular function (brachial artery flow-mediated dilation), and the maximal vasodilatory response after ischemic handgrip exercise (an estimate of microvascular remodeling) were assessed before and after exercise training in nonburned control subjects (n = 11) and individuals with burn injuries covering a moderate body surface area (26% ± 7%; n = 13) and a high body surface area (59% ± 15%; n = 19).
RESULTS


Peak vascular conductance and area under the curve during postocclusive reactive hyperemia increased from pretraining to posttraining in control and burn injury groups (both P < 0.05), the magnitude of which did not differ between groups (both P = 0.6). Likewise, the maximal vasodilatory response after ischemic handgrip exercise increased in all groups after exercise training (P < 0.05). Macrovascular dilator function did not differ across time or between groups (P = 0.8).
CONCLUSIONS


These data suggest that a community-based exercise training program improves microvascular function in individuals with well-healed burn injuries, which may be due in part to vascular remodeling.",2020,"Macrovascular dilator function did not differ across time or between groups (P = 0.8).
","['individuals with well-healed burn injuries', 'Burn Injury Survivors', 'nonburned control subjects (n = 11) and individuals with burn injuries covering a moderate body surface area (26% ± 7%; n = 13) and a high body surface area (59% ± 15%; n = 19']","['ischemic handgrip exercise', 'community-based exercise training program', 'exercise training', 'Exercise Training']","['macrovascular dilator function', 'Microvascular Function', 'maximal vasodilatory response after ischemic handgrip exercise', 'microvascular dilator function', 'Macrovascular dilator function', 'Peak vascular conductance and area under the curve during postocclusive reactive hyperemia', 'Microvascular function (forearm reactive hyperemia), macrovascular function (brachial artery flow-mediated dilation', 'microvascular function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0180431', 'cui_str': 'Dilator'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.019027,"Macrovascular dilator function did not differ across time or between groups (P = 0.8).
","[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': '1University of Texas Southwestern Medical Center and Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, TX 2University of North Texas Health Science Center, Ft. Worth, TX.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Moralez', 'Affiliation': ''}, {'ForeName': 'Manall F', 'Initials': 'MF', 'LastName': 'Jaffery', 'Affiliation': ''}, {'ForeName': 'M U', 'Initials': 'MU', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Engelland', 'Affiliation': ''}, {'ForeName': 'Matthew N', 'Initials': 'MN', 'LastName': 'Cramer', 'Affiliation': ''}, {'ForeName': 'Craig G', 'Initials': 'CG', 'LastName': 'Crandall', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002379']
3418,33057367,Higher iron stores and the HFE 187C>G variant delay onset of peripheral neuropathy during combination antiretroviral therapy.,"OBJECTIVE


People with HIV (PWH) continue to experience sensory neuropathy and neuropathic pain in the combination antiretroviral therapy (cART) era for unclear reasons. This study evaluated the role of iron in a previously reported association of iron-loading hemochromatosis (HFE) gene variants with reduced risk of neuropathy in PWH who received more neurotoxic cART, since an iron-related mechanism also might be relevant to neuropathic symptoms in PWH living in low-resource settings today.
DESIGN


This time-to-event analysis addressed the impact of systemic iron levels on the rapidity of neuropathy onset in PWH who initiated cART.
METHODS


Soluble transferrin receptor (sTFR), the sTFR-ferritin index of iron stores, and high-sensitivity C-reactive protein (hsCRP) levels were determined in stored baseline sera from participants of known HFE genotype from AIDS Clinical Trials Group (ACTG) Study 384, a multicenter randomized clinical trial that evaluated cART strategies. Associations with incident neuropathy were evaluated in proportional-hazards, time-to-event regression models, adjusting for potential confounders.
RESULTS


Of 151 eligible participants with stored serum who were included in the original genetic study, 43 had cART-associated neuropathy; 108 had sufficient serum for analysis, including 30 neuropathy cases. Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05). Higher sTFR or iron stores, the HFE 187C>G variant, and lower baseline hsCRP were associated with significantly delayed neuropathy in self-reported whites (n = 28; all p-values<0.05), independent of age, CD4+ T-cell count, plasma HIV RNA, and cART regimen.
CONCLUSIONS


Higher iron stores, the HFE 187C>G variant, and lower hsCRP predicted delayed onset of neuropathy among self-reported white individuals initating cART. These findings require confirmation but may have implications for cART in HIV+ populations in areas with high endemic iron deficiency, especially those PWH in whom older, more neurotoxic antiretroviral drugs are occasionally still used.",2020,Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05).,"['151 eligible participants with stored serum who were included in the original genetic study', 'People with HIV (PWH']",[],"['Higher sTFR or iron stores', 'systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels', 'sTFR-ferritin index of iron stores, and high-sensitivity C-reactive protein (hsCRP) levels']","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",151.0,0.107466,Carriers of HFE variants had higher systemic iron (lower sTFR and sTFR-ferritin index) and lower hsCRP levels than non-carriers (all p<0.05).,"[{'ForeName': 'Asha R', 'Initials': 'AR', 'LastName': 'Kallianpur', 'Affiliation': 'Genomic Medicine Institute, Cleveland Clinic/Lerner Research Institute, Cleveland, Ohio, United States of America.'}, {'ForeName': 'Wanqing', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Angelika L', 'Initials': 'AL', 'LastName': 'Erwin', 'Affiliation': 'Genomic Medicine Institute, Cleveland Clinic/Lerner Research Institute, Cleveland, Ohio, United States of America.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Clifford', 'Affiliation': 'Division of Infectious Diseases, Departments of Medicine and Neurology, Washington University School of Medicine, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hulgan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Robbins', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}]",PloS one,['10.1371/journal.pone.0239758']
3419,33064621,Teaching pursed-lip breathing through music: MELodica Orchestra for DYspnea (MELODY) trial rationale and protocol.,"BACKGROUND


Patients with chronic obstructive pulmonary disease (COPD) commonly experience dyspnea, which may limit activities of daily living. Pursed-lip breathing improves dyspnea for COPD patients; however, access to pursed-lip breathing training is limited.
METHODS


The proposed MELodica Orchestra for DYspnea (MELODY) study will be a single-site pilot study to assess the safety, feasibility, and efficacy of a music-based approach to teach pursed-lip breathing. Patients with COPD and moderate-severe dyspnea are randomized to intervention, education-control, or usual care control groups. Intervention patients meet twice weekly for eight weeks for melodica instruction, group music-making, and COPD education. Safety, feasibility, and efficacy is assessed qualitatively and quantitatively.
RESULTS


This manuscript describes the rationale and methods of the MELODY pilot project.
CONCLUSIONS


If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.",2020,"If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.","['COPD patients', 'Patients with COPD and moderate-severe dyspnea', 'Patients with chronic obstructive pulmonary disease (COPD']","['music-based approach to teach pursed-lip breathing', 'Pursed-lip breathing']","['dyspnea', 'Safety, feasibility, and efficacy']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.106147,"If pilot data demonstrate efficacy, then a multi-site randomized control trial will be conducted to evaluate program effectiveness and implementation.","[{'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'McGrath', 'Affiliation': 'Indiana University School of Medicine , Indianapolis, IN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Indiana University School of Medicine , Indianapolis, IN, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Rattray', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Lillie', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Crow', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Myers', 'Affiliation': 'Department of Internal Medicine, Indiana University School of Medicine , Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Myers', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wasmuth', 'Affiliation': 'School of Occupational Therapy, Indiana University School of Health & Human Sciences , Indianapolis, IN, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Burns', 'Affiliation': 'Department of Music and Arts Technology, Indiana University-Purdue University Indianapolis (IUPUI) , Indianapolis, IN, USA.'}, {'ForeName': 'Ariel J', 'Initials': 'AJ', 'LastName': 'Cheatham', 'Affiliation': 'Department of Veterans Affairs (VA) Health Services Research and Development (HSR&D) Precision Monitoring to Transform Care (PRISM) Quality Enhancement Research Initiative (QUERI) , Indianapolis, IN, USA.'}, {'ForeName': 'Himalaya', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'VA HSR&D Center for Health Information and Communication (CHIC), Richard L. Roudebush VA Medical Center , Indianapolis, IN, USA.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Bravata', 'Affiliation': 'Department of Internal Medicine, Indiana University School of Medicine , Indianapolis, IN, USA.'}]",Arts & health,['10.1080/17533015.2020.1827277']
3420,33065342,Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.,"PURPOSE


In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
METHODS


Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
CONCLUSIONS


In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.",2020,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","['Patients', 'reference) group ', 'advanced breast cancer', 'patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer']","['ribociclib plus fulvestrant or placebo plus fulvestrant', 'Ribociclib plus fulvestrant', 'placebo', 'ribociclib plus fulvestrant', 'ribociclib', 'placebo plus fulvestrant']","['worst pain item score', 'progression-free survival (PFS) and overall survival (OS', 'BPI-SF pain severity index score', 'Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire', 'health-related quality of life (HRQOL', 'fatigue and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.436342,"RESULTS


Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'CHU de Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Régional Du Cancer, Strasbourg, France.'}, {'ForeName': 'Giulia V', 'Initials': 'GV', 'LastName': 'Bianchi', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': 'Practice for Haematology and Internal Oncology, Velbert, Germany.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.09.008']
3421,33038005,General Practitioner Use of Generically Substitutable Inhaler Devices and the Impact of Training on Device Mastery and Maintenance of Correct Inhaler Technique.,"INTRODUCTION


Generic substitution of inhaler devices is a relatively new phenomenon. The best patient outcomes associated with generic substitution occur when prescribers obtain consent from their patients to prescribe a generic inhaler and also teach their patient how to correctly use the new device. To date, no prospective observational study has assessed the level of training required for general practitioners (GPs) to demonstrate correct inhaler technique using two dry powder inhaler devices delivering fixed-dose combination budesonide/formoterol therapy. This study aims to (1) determine the level of training required for GPs to master and maintain correct IT when using two different dry powder inhalers that are able to be substituted in clinical practice and (2) determine the number and types of errors made by GPs on each device and inhaler device preference at each training visit.
METHOD


A randomized, parallel-group cross-over study design was used to compare the inhaler technique of participants with a Spiromax ®  placebo device and a Turbuhaler ®  placebo device. This study consisted of two visits with each participant over a period of 4 ± 1 weeks (visit 1 and visit 2). A total of six levels of assessment and five levels of training were implemented as required. Level 1, no instruction; level 2, following use of written instruction; level 3, following viewing of instructional video; level 4, expert tuition from the researcher; level 5/level 6, repeats of expert tuition from the researcher when required. Participants progressed through each level and stopped at the point at which they demonstrated device mastery. At each level, trained researchers assessed the inhaler technique of the participants. Participants were also surveyed about their previous inhaler use and training.
RESULTS


In total, 228 GPs participated in this study by demonstrating their ability to use a Turbuhaler ®  and a Spiromax ®  device. There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler ®  compared with the Spiromax ®  at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data). All but one participant had demonstrated correct inhaler technique for both devices by level 3(instructional video). There was a significant difference between the proportion of participants who demonstrated maintenance of device mastery with the Turbuhaler ®  compared with the Spiromax ®  at visit 2, level 1 (127/177 (72%) versus 151/177 (85%) respectively, p = 0.003; McNemar's test of paired data). All but two participants achieved device mastery by level 3, visit 2. More participants reported previous training with the Turbuhaler ®  than with Spiromax ® .
DISCUSSION


This study demonstrates that GPs are able to equally demonstrate correct use of the Turbuhaler ®  and Spiromax ®  devices, even though most had not received training on a Spiromax ®  device prior to this study. The significance of being able to demonstrate correct technique on these two devices equally has ramifications on practice and supported generic substitution of inhaler devices at the point of prescribing, as the most impactful measure a GP can take to ensure effective use of inhaled medicine is the correct demonstration of inhaler technique.",2020,"There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler ®  compared with the Spiromax ®  at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data).","['participants with a\xa0Spiromax ®  placebo device and a Turbuhaler ®  placebo device', 'general practitioners (GPs']",['budesonide/formoterol therapy'],['device mastery'],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",228.0,0.128921,"There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler ®  compared with the Spiromax ®  at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar's test of paired data).","[{'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Cvetkovski', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. biljana.cvetkovski@sydney.edu.au.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hespe', 'Affiliation': 'School of Medicine, The University of Notre Dame Australia, Sydney, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Tan', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Kritikos', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Azzi', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Sinthia', 'Initials': 'S', 'LastName': 'Bosnic-Anticevich', 'Affiliation': 'Quality Use of Respiratory Medicine Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.'}]",Pulmonary therapy,['10.1007/s41030-020-00131-8']
3422,33035067,Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior.,"Objectives:  Parent management training is an effective treatment for disruptive behavior disorders but it is often underutilized in clinical settings. Access to care is limited due to logistical barriers as well as limited service availability. This study examines in an open trial the acceptability, feasibility, and clinical effects of a digital parent management training intervention that includes videoconference coaching, called ""Tantrum Tool.""  Methods:  Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention. The primary symptom measure was the Disruptive Behavior Rating Scale (DBRS), and the secondary outcome measure was the Affective Reactivity Index (ARI) completed by the primary caregiver before and after treatment.  Results:  Treatment retention was high (80%), and parents reported a high level of satisfaction with the program. There was a significant reduction in the mean DBRS score from 13.5 ± 5.5 at baseline to 7.3 ± 3.4 at endpoint,  p  < 0.001. There was also a significant reduction in the mean ARI irritability score from 7.2 ± 2.6 at baseline to 3.75 ± 2.1 at endpoint,  p  < 0.01.  Conclusions:  This open pilot study supports the feasibility and acceptability of a digital parent training program for young children with disruptive behavior. Findings provide preliminary support for a clinically meaningful reduction of both disruptive behavior and irritability. Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children. ClinicalTrials.gov: NCT03697837.",2020,Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children.,"['young children', 'Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention', 'young children with disruptive behavior']","['Parent management training', 'Online Parent Training', 'digital parent management training intervention', 'digital parent training program']","['mean DBRS score', 'Affective Reactivity Index (ARI', 'Disruptive Behavior Rating Scale (DBRS', 'mean ARI irritability score', 'Treatment retention']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",15.0,0.023215,Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Diaz-Stransky', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Zecher', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grodberg', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Sukhodolsky', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0089']
3423,33035741,"Differentiating ""types"" of treatment dropout: Nonstarters in an RCT of prolonged exposure versus sertraline.","Despite effective interventions for posttraumatic stress disorder (PTSD), many patients prematurely drop out. Differentiating ""types"" of dropout at various stages of treatment may improve our ability to predict and prevent attrition. Using data from a doubly randomized preference trial, this study examined patient dropout prior to treatment and compared these ""nonstarters"" with treatment starters and in-treatment dropouts. Patients (N = 200) with chronic PTSD were randomized to ""choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline) and received up to 10 weeks of treatment. Overall dropout rate was 33.0% (n = 66). A substantial minority were nonstarters (n = 19; 28.8%). Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001). These differences remained even when comparing nonstarters to patients that began treatment but eventually dropped out. Differences in beliefs (i.e., perceived credibility) toward one treatment versus the other were also linked to pretreatment dropout. Reasons underlying dropout likely differ during various treatment stages. Better understanding risk factors for types of dropout may inform strategies to boost engagement and retention, ultimately improving patient outcomes.",2020,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).",['Patients (N\xa0=\xa0200) with chronic PTSD'],"['choice"" (prolonged exposure [PE] or sertraline) or ""no choice"" (re-randomized to PE or sertraline', 'sertraline']","['Overall dropout rate', 'severe PTSD symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]",200.0,0.0323563,"Relative to patients who began treatment, nonstarters reported less severe PTSD symptomatology (p = .03, d = 0.57) and were less likely to have received their preferred treatment (p < .001).","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Kline', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA. Electronic address: ack63@case.edu.'}, {'ForeName': 'Allison L', 'Initials': 'AL', 'LastName': 'Baier', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Klein', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'PTSD Treatment and Research Program, Case Western Reserve University, Department of Psychological Sciences, 11220 Bellflower Road, Cleveland, OH, 44106-7123, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Center for Anxiety and Traumatic Stress, University of Washington, Department of Psychology, Guthrie Hall, Box 351525, Seattle, WA, 98195-1525, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103750']
3424,33038782,Effects of chamomile extract nasal drop on chronic rhinosinusitis treatment: A randomized double blind study.,"OBJECTIVES


Recently, more attention has been paid to herbal treatment in chronic rhinosinusitis (CRS) patients. Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties. This study aimed to evaluate the effects of chamomile extract on the clinical symptoms of patients with CRS in a university hospital.
MATERIALS AND METHODS


In a randomized double-blind placebo-group clinical trial, 74 CRS patients were examined by an otolaryngologist blinded to the study groups, and the effects of treatment (according to SNOT-22 questionnaire) and possible complications recorded. Statistical analysis performed using SPSS software version 21, and level of significance considered as P < 0.05.
RESULTS


Of the 74 patients (31 females and 43 male), 37 cases randomized in the intervention and 37 cases in the placebo group. The Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22 were not significantly different at baseline visit between the two study groups. The adjusted mean score of quality of life during the four time periods in the intervention group (34.3, confidence interval of 95%: 31.8-36.7) was significantly lower than that of control group (45.9, confidence interval of 95%: 43.5-48.4) (P-value = 0.001). Also, clinical improvement in endoscopic nasal examination was significant in intervention group compared with placebo group.
CONCLUSION


Chamomile extract is effective in further reducing the clinical symptoms and improving the quality of life of CRS patients.",2020,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"['74 CRS patients', '74 patients (31 females and 43 male', 'patients with CRS in a university hospital', 'chronic rhinosinusitis treatment', 'chronic rhinosinusitis (CRS) patients']","['chamomile extract nasal drop', 'Chamomile (Matrricaria chamomilla', 'chamomile extract', 'placebo', 'Chamomile extract']","['adjusted mean score of quality of life', 'Lund-Mackay score, clinical findings in endoscopic nasal examination and mean score of the SNOT-22', 'endoscopic nasal examination', 'quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439963', 'cui_str': 'Chamomile extract'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]",74.0,0.418448,Chamomile (Matrricaria chamomilla) has extensive clinical uses in traditional-Persian medicine for its therapeutic properties.,"[{'ForeName': 'Shadman', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yousefbeyk', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh Matin', 'Initials': 'SM', 'LastName': 'Ebrahimi', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Ali Faghih', 'Initials': 'AF', 'LastName': 'FaghihHabibi', 'Affiliation': 'Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: dr.faghih.habibi@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Cardiovascular Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Ramezani', 'Affiliation': 'Otorhinolaryngology Research Center, Amiralmomenin Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102743']
3425,33038832,Effect of omega-3 lcpufa supplementation on maternal fatty acid and oxylipin concentrations during pregnancy.,"INTRODUCTION


Omega-3 long chain polyunsaturated fatty acids (LCPUFA) have been associated with a reduction in risk for preterm birth. However, there is limited understanding of how fatty acids and their bioactive derivatives (oxylipins) change over the course of pregnancy. Here we document the changes in concentration of fatty acids and oxylipins during pregnancy and how fatty acid status and oxylipin concentrations are affected by supplementation with omega-3 LCPUFA. We also investigate the degree to which fatty acid and oxylipin changes across pregnancy are influenced by baseline omega-3 status.
MATERIALS AND METHODS


We profiled the fatty acids in all lipids in dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins in separate dried blood spot samples by LC-MS-MS collected from a random sample of 1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial. ORIP is a double-blind, randomized controlled trial involving 5544 participants and designed to determine the effect of supplementing the diets of pregnant women with omega-3 LCPUFA on the incidence of early preterm birth. Maternal whole blood finger prick samples were collected at baseline (~14 weeks gestation) and at completion of the study intervention period (34 weeks gestation).
RESULTS


The concentration of most total and free polyunsaturated fatty acids and their associated oxylipins declined over the course of pregnancy. Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA. The intervention had minimal or no effect on free EPA, LA, AA and their associated oxylipins. Omega-3 LCPUFA supplementation in women with higher omega-3 status at baseline was associated with a significant increase in 7-HDHA and 4-HDHA between the treatment and control whereas there were no differences between groups in 7-HDHA and 4-HDHA in women with intermediate or lower baseline omega-3 status.
CONCLUSION


Our data suggest a differential response with or without omega-3 supplementation for DHA and DHA-derived oxylipins, which may have an important role to play in modulating pregnancy duration. Further work is needed to understand their role, which may allow us to better tailor omega-3 supplementation for preterm birth prevention.",2020,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","['5544 participants', '1263 women with a singleton pregnancy who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) trial', 'pregnant women with']","['Omega-3 long chain polyunsaturated fatty acids (LCPUFA', 'omega-3 lcpufa supplementation', 'omega-3 LCPUFA', 'dried blood spots (total blood fatty acids) by gas chromatography and free (unesterified) fatty acids and their associated oxylipins', 'ORIP', 'Omega-3 LCPUFA supplementation']","['incidence of early preterm birth', '7-HDHA and 4-HDHA', 'Maternal whole blood finger prick samples', 'total DHA and 7-HDHA', 'free EPA, LA, AA and their associated oxylipins', 'maternal fatty acid and oxylipin concentrations', 'concentration of most total and free polyunsaturated fatty acids']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008555', 'cui_str': 'Gas chromatography measurement'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",5544.0,0.103295,"Omega-3 LCPUFA supplementation increased total DHA and 7-HDHA and mitigated the decline in free DHA, 4-HDHA and 14-HDHA.","[{'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA. Electronic address: karen.best@sahmri.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Agriculture, Food and Wine, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gomersall', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Public Health, University of Adelaide, North Terrace, Adelaide SA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'South Australian Health and Medical Research Institute, SAHMRI Women and Kids, North Terrace, Adelaide SA; School of Medicine, University of Adelaide, North Terrace, Adelaide SA.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102181']
3426,33038833,"Long-term docosahexaenoic acid (DHA) supplementation in cystic fibrosis patients: a randomized, multi-center, double-blind, placebo-controlled trial.","BACKGROUND


Cystic fibrosis (CF) patients have an alteration in fatty acid (FA) metabolism, associated with increased omega-6 and low omega-3 FA. Previous studies on supplementation with omega-3 FA in CF had contradictory results, and to date there is no evidence to recommend routine use of omega-3 supplements in CF patients. We hypothesized that long-term supplementation with docosahexaenoic acid (DHA) will have beneficial effects in these patients, by reducing pulmonary, systemic and intestinal inflammation.
METHODS


This was a randomized, double-blind, parallel, placebo-controlled trial. CF patients (age >2 months) were randomized to receive a seaweed DHA oil solution (50 mg/Kg/day) or matching placebo for 48 weeks. Primary outcomes were pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers. Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
RESULTS


Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48 placebo) were included. At trial completion, there were no differences in all primary outcomes [serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers, or in any of the clinical outcomes evaluated. There were few adverse events, with similar incidence in both study groups.
CONCLUSION


In this study, long-term DHA supplementation in CF patients was safe, but did not offer any benefit on inflammatory biomarkers, or in clinical outcomes compared with placebo. (NCT01783613).",2020,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","['cystic fibrosis patients', 'Ninety six CF patients, 44 female, age 14.6±11.9 years (48 DHA and 48', 'Cystic fibrosis (CF) patients', 'CF patients', 'CF patients (age >2 months']","['docosahexaenoic acid (DHA) supplementation', 'seaweed DHA oil solution', 'placebo', 'matching placebo', 'docosahexaenoic acid (DHA']","['serum-IL-8 (p=0.909), respiratory-IL-8 (p=0.384) or fecal calprotectin (p=0.948)], all secondary inflammatory biomarkers', 'pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life', 'pulmonary (interleukin [IL]-8), systemic (IL-8) and intestinal (calprotectin) inflammatory biomarkers']","[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036500', 'cui_str': 'Macroalgae'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",96.0,0.816089,"Secondary outcomes included other pulmonary (IL-1β, IL-6, neutrophil elastase, lactate and calprotectin) and systemic (serum-IL-1β, IL-6) inflammatory biomarkers, as well as clinical outcomes (FEV 1 , pulmonary exacerbations, antibiotic use, nutritional status and quality of life).
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'López-Neyra', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain. Electronic address: alneyra@salud.madrid.org.'}, {'ForeName': 'Lucrecia', 'Initials': 'L', 'LastName': 'Suárez', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Blas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ruiz de Valbuena', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Garriga', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Endocrinología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Calvo', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ribes', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario La Fe. Avinguda de Fernando Abril Martorell, 106. 46026-Valencia. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Girón Moreno', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario La Princesa. Instituto de Investigación Sanitaria La Princesa. Calle de Diego de León, 62. 28006-Madrid. Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Máiz', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Unidad de Fibrosis Quística. Servicio de Neumología. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'González', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bousoño', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Central de Asturias. Av. Roma. 33011-Oviedo. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Manzanares', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Doce de Octubre. Avda. de Córdoba. 28041-Madrid. Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Pastor', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Bioquímica Clínica, UCA-CCM. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez-Botas', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Fisiopatología Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain; Servicio de Bioquímica-Investigación. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Del Campo', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cantón', 'Affiliation': 'Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Servicio de Microbiología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Garbiñe', 'Initials': 'G', 'LastName': 'Roy', 'Affiliation': 'Servicio de Inmunología, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menacho', 'Affiliation': 'Servicio de Bioquímica Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': 'Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Soriano', 'Affiliation': 'Hospital Universitario La Princesa. Universidad Autónoma de Madrid. Calle de Diego de León, 62. 28006-Madrid. Spain; Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III. Av. Monforte de Lemos, 3-5. 28029-Madrid. Spain.'}, {'ForeName': 'Adelaida', 'Initials': 'A', 'LastName': 'Lamas', 'Affiliation': 'Unidad de Fibrosis Quística. Servicio de Pediatría. Hospital Universitario Ramón y Cajal. Cª Colmenar Km. 9,1. 28034-Madrid. Spain; Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS). Cª Colmenar Km. 9,1. 28034-Madrid. Spain.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102186']
3427,33043638,"Helping Couples Connect during the COVID-19 Pandemic: A Pilot Randomised Controlled Trial of an Awareness, Courage, and Love Intervention.","BACKGROUND


A second pandemic of mental health problems due to COVID-19 is predicted, suggesting a demand for interventions to mitigate its impacts. This study evaluated the effectiveness of an online psychological intervention based on the Awareness, Courage, and Love (ACL) model from Functional Analytic Psychotherapy to promote closeness between couples during the pandemic.
METHOD


Thirty-one couples were randomised into either the intervention or control group for a 2-hour online group session. The intervention was designed to increase closeness between couples, whereas control group members watched a movie. In both groups, participants responded to two instruments that assessed the couple's relationship. Generalised linear mixed modeling was used to compare the change scores over time between the groups, with random effects used to control for the correlation within a couple and the correlation within the individual.
RESULTS


The intervention group's closeness increased by 23 per cent while the control group's closeness increased only 2 per cent. A week later, a significant difference between the two groups emerged on closeness.
CONCLUSION


Online ACL protocols requiring minimal training offer a promising intervention to quickly buffer against stress for large numbers of individuals during pandemic times.",2020,The intervention group's closeness increased by 23 per cent while the control group's closeness increased only 2 per cent.,['Thirty-one couples'],"['control group members watched a movie', 'online psychological intervention based on the Awareness, Courage, and Love (ACL) model from Functional Analytic Psychotherapy']",[],"[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0870365', 'cui_str': 'Bravery'}, {'cui': 'C0024028', 'cui_str': 'Love'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",[],31.0,0.0271658,The intervention group's closeness increased by 23 per cent while the control group's closeness increased only 2 per cent.,"[{'ForeName': 'Mavis', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Hardebeck', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Fabiana Pinheiro', 'Initials': 'FP', 'LastName': 'Ramos', 'Affiliation': 'Federal University of Espirito Santo, Brazil.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Turlove', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Nordal-Jonsson', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Akoly', 'Initials': 'A', 'LastName': 'Vongdala', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""China Women's University, China.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Kohlenberg', 'Affiliation': 'University of Washington, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12241']
3428,33044203,Effects of insole on the less affected side during execution of treadmill walking training on gait ability in chronic stroke patients: A preliminary study.,"BACKGROUND


People who have had hemiplegic stoke generally move more weight to the unaffected side than the affected side, resulting in asymmetrical posture and decreased ability in walking.
OBJECTIVES


This study sought to investigate the effect of inducing a weight shift to the affected side by raising the shoe height of the less affected side using an insole during the execution of treadmill training on gait ability in people with chronic stroke.
METHODS


The subjects were randomly assigned into two groups: insole on less affected side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW) group. The treadmill training was conducted for 30 minutes per session, 5 times a week, for 4 weeks. A gait analyzer based on body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6 MWT), was measured before first intervention and after twentieth treadmill training intervention (Trial registration number is KCT0003830).
RESULTS


The results revealed statistically significant differences between the two groups in the Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT of the gait test. In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
CONCLUSIONS


ILTW, more than NTW, may improve walking ability in people with chronic stroke as it increases the weight-support ratio by adjusting the shoe height of the unaffected side using an insole.",2020,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","['chronic stroke patients', 'People who have had hemiplegic stoke', 'people with chronic stroke']","['side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW', 'treadmill walking training', 'treadmill training']","['Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT after execution of training', 'weight-support ratio', 'body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6\u200aMWT', 'Speed, Cadence, FGA, F8WT, and 6\u200aMWT', 'gait ability', 'walking ability', 'Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT of the gait test']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0322436,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, Raon Hue Hospital, Sinwol-ro, Yangcheon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Kyuenam', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201040']
3429,33044213,The effects of bright light treatment via ear canals on quality of sleep and depressive mood among overworked employees: A randomized-controlled clinical trial.,"BACKGROUND


Many overworked employees need tools to improve their depressive mood or sleep disorder. In Finland, a new device of bright light therapy was developed.
OBJECTIVE


Our objective was to evaluate the effect of bright light treatment via ear canals on improving the depressive mood and sleep disorder.
METHODS


We conducted a randomized, controlled, crossover designed, open-label trial. We examined 27 participants aged 23-52 years, assigned to either Early treatment or Later treatment groups. The Early treatment group used the device on weekdays for the first 4 weeks, followed by a 4-week observation period. The Later treatment group had an observation period for the first 4 weeks, followed by device treatment for the subsequent 4 weeks. Every Friday, the participants were asked to answer questionnaires: A Self-rating Depression Scale (SDS), an Athens Insomnia Scale (AIS), and a Profile of Mood States (POMS) Brief Form.
RESULTS


While no significant effect was found on the SDS following treatment (p = 0.16), the AIS showed a significant improvement (p = 0.004), and the scores for the Depression (D) and Vigor (V) of POMs decreased significantly (p = 0.045, p = 0.006, respectively).
CONCLUSIONS


Bright light treatment via ear canals may improve sleep quality and depressive mood.",2020,"While no significant effect was found on the SDS following treatment (p = 0.16), the AIS showed a significant improvement (p = 0.004), and the scores for the Depression (D) and Vigor (V) of POMs decreased significantly (p = 0.045, p = 0.006, respectively).
","['27 participants aged 23-52 years', 'among overworked employees']",['bright light treatment via ear canals'],"['scores for the Depression (D) and Vigor (V) of POMs', 'depressive mood and sleep disorder', 'quality of sleep and depressive mood', 'sleep quality and depressive mood', 'A Self-rating Depression Scale (SDS), an Athens Insomnia Scale (AIS), and a Profile of Mood States (POMS']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2937246', 'cui_str': 'Overwork'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013444', 'cui_str': 'External auditory canal structure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",27.0,0.069277,"While no significant effect was found on the SDS following treatment (p = 0.16), the AIS showed a significant improvement (p = 0.004), and the scores for the Depression (D) and Vigor (V) of POMs decreased significantly (p = 0.045, p = 0.006, respectively).
","[{'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Basic Nursing and Health Science, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tanigawa', 'Affiliation': 'Department of Public Health, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Koutatsu', 'Initials': 'K', 'LastName': 'Maruyama', 'Affiliation': 'Special Course of Food and Health Science, Department of Bioscience Graduate School of Agriculture, Ehime University, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Kanehisa', 'Initials': 'K', 'LastName': 'Morimoto', 'Affiliation': 'Human Factors Research Institute, Japan Foundation for Environmental Health Sciences, Minato-ku, Tokyo, Japan.'}]","Work (Reading, Mass.)",['10.3233/WOR-203282']
3430,33039717,Nasal function and cardio-respiratory capacity of adolescent with external nasal dilator.,"BACKGROUND


the external nasal dilator (END) has been employed for the purpose of aiding sporting performance. The objective of this study was to evaluate nasal function and cardio-respiratory capacity in healthy adolescent athletes using the END.
METHODS


double-blind, crossover clinical trial in which adolescents were evaluated while using the experimental and placebo END during physical exercise. Values for peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max) were obtained in randomized order. Additionally, the rating of perceived exertion (RPE) after the cardio-respiratory test was assessed.
RESULTS


for the 71 adolescents evaluated, the use of the experimental END, compared to the placebo, produced a significant improvement in values of PNIF (177.4 ± 20.9 L/min and 172.8 ± 20.2 L/min) (p = 0.020), NR (0.24 ± 0.16 and 0.27 ± 0.16) (p = 0.007), VO 2 max. (39.5 ± 5.2 mL/kg. min-1 and 37.5 ± 5.2 mL/kg. min-1) (p < 0.001) and RPE (6.0 ± 2.2 and 5.5 ± 2.4) (p < 0.001), respectively.
CONCLUSION


the END reduced NR, increased PNIF and improved VO 2 max. In addition, it improved RPE after the maximal cardio-respiratory test. The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.",2020,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","['adolescent with external nasal dilator', 'healthy adolescent athletes', 'adolescent athletes']","['placebo', 'external nasal dilator (END']","['rating of perceived exertion (RPE', 'Nasal function and cardio-respiratory capacity', 'values of PNIF', 'nasal function and cardio-respiratory capacity', 'PNIF and improved VO 2 max', 'nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion', 'peak nasal inspiratory flow (PNIF), nasal resistance (NR) and maximal oxygen uptake (VO 2 max']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0180437', 'cui_str': 'Nasal dilator'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",,0.146487,"The use of the END can significantly improve nasal function, increase cardio-respiratory capacity and reduce rating of perceived exertion during a maximal test involving adolescent athletes.","[{'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Santos Ferreira', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Ricardo Reis', 'Initials': 'RR', 'LastName': 'Dinardi', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil; Pontifical Catholic University of Minas Gerais, Department of Physical Education. Belo Horizonte, MG, Brazil. Electronic address: dinardi06@hotmail.com.'}, {'ForeName': 'Cássio', 'Initials': 'C', 'LastName': 'da Cunha Ibiapina', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Ribeiro de Andrade', 'Affiliation': 'Federal University of Minas Gerais, Post Graduate Program in Health Sciences, Faculty of Medicine, Department of Pediatrics, Belo Horizonte, MG, Brazil.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110430']
3431,33039853,Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study.,"OBJECTIVES


Parkinson's disease (PD) causes dysfunction both to swallowing and to the cough mechanism. Oropharyngeal dysphagia is the main cause of pneumonia, due to silent aspiration of food and saliva. Pneumonia is the leading cause of death in PD. Different strategies exist to reduce the risk of inhalation and associated lung infections, but evidence of their efficacy is still unclear. The aim of this preliminary study was to investigate if adding an expiratory flow acceleration (EFA®) technique to standard therapy (ST) for dysphagia can reduce the incidence of bronchopulmonary infections and improve quality of life, respiratory function parameters, cough, and airways encumbrance perception.
MATERIALS AND METHODS


Twenty-five patients with PD were randomized to two groups: ST vs. ST + EFA. Patients were re-assessed at 30, 180 and 360 days from start of treatment. The primary outcome was the incidence of respiratory exacerbations together with quality of life score (PDQ-39). Secondary outcomes were changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS).
RESULTS


Twenty patients concluded the study (10 each group). Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group. Furthermore, there was a significant difference in cough effectiveness measured with the peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS).
CONCLUSION


The results of this preliminary study support the use of EFA® technology in Parkinson's patients with dysphagia to reduce the risk of respiratory complications. Nevertheless, further studies are needed in a larger, more representative sample to definitively confirm the usefulness of this technique in PD patients.",2020,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[""Parkinson's patients with dysphagia"", 'Twenty-five patients with PD', 'Twenty patients concluded the study (10 each group', ""patients with Parkinson's disease and swallowing deficiency""]","['expiratory flow acceleration (EFA®) technique to standard therapy (ST', 'EFA® technology', 'expiratory flow acceleration', 'ST vs. ST\u202f+\u202fEFA']","['cough effectiveness', 'changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS', 'peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS', 'respiratory infections, symptoms, hospital admissions and medical visits', 'incidence of respiratory exacerbations together with quality of life score (PDQ-39', 'quality of life, respiratory function parameters, cough, and airways encumbrance perception']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",25.0,0.0541415,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Riboldazzi', 'Affiliation': ""Parkinson's Disease Unit, Gaetano and Piera Borghi Foundation, Brebbia, Italy.""}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Spinazza', 'Affiliation': 'Neurology Rehabilitation Department, Hospital of Cuasso al Monte, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beccarelli', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Prato', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Grecchi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Abrosca"", 'Affiliation': 'Italian Association of Respiratory Physiotherapists (ARIR), Milan, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy. Electronic address: antonellonicolini@gmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106249']
3432,33044838,A Biomechanical Comparison of 2 Hip Capsular Reconstruction Techniques: Iliotibial Band Autograft Versus Achilles Tendon Allograft.,"BACKGROUND


Several techniques for hip capsular reconstruction have been described to address gross instability or microinstability due to capsular deficiency. However, objective biomechanical data to support their use are lacking.
PURPOSE


To compare the kinematic effect of 2 capsular reconstruction techniques (iliotibial band [ITB] graft and Achilles tendon graft). Kinematic effect encompassed rotational range of motion (ROM) as well as joint translation in the coronal, sagittal, and axial planes.
STUDY DESIGN


Controlled laboratory study.
METHODS


8 paired, fresh-frozen hemi-pelvises (16 hips) were tested on a custom-designed joint motion simulator in the intact state and after capsulectomy. Pairs were randomly allocated to either ITB or Achilles reconstruction and retested. Testing was performed at 0°, 45°, and 90° of flexion. Internal-external rotation (IR-ER) torques and abduction-adduction torques of 3 N·m were applied to the femur via a load cell at each position, and rotational ROM and joint translation in the coronal, sagittal, and axial planes were recorded.
RESULTS


At 45° and 90°, there was a significant effect of the condition of the hip on the total IR-ER ( P  = .004, effect size [ES] = 0.305; and  P  < .001, ES = 0.497; respectively). At 45°, mean ± SD total rotation was significantly greater for the capsulectomy (59.7°± 15.9°) state compared with intact (53.3°± 13.2°;  P  = .007). At 90°, reconstruction significantly decreased total rotation to 49.0°± 18.9° compared with a mean total rotation of 52.8°± 18.7° after capsulectomy ( P  = .02). No difference was seen in the total abduction-adduction of the hip between conditions. Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes. For translation, at both 0° and 45° there was a statistically significant effect of the condition on the medial-lateral translation ( P  = .033; ES = 0.204). Reconstruction, independent of technique, was successful in significantly decreasing ( P  = .030;  P  = .014) the mean medial-lateral translation at 0° and 45° of hip flexion from 5.2 ± 3.8 mm and 5.6 ± 4.0 mm to 2.8 ± 1.9 mm and 3.9 ± 3.2 mm, respectively.
CONCLUSION


The integrity of the native hip capsule played a significant role in rotational stability, where capsulectomy significantly increased rotational ROM. Both ITB and Achilles reconstruction techniques restored normal rotational ROM of the hip at 90° of flexion as well as coronal plane stability at 0° and 45° of hip flexion. No differences were seen between ITB and Achilles reconstruction techniques.
CLINICAL RELEVANCE


Both capsular reconstruction techniques provide comparable joint kinematics, restoring rotation and translation to normal values with the exception of rotational ROM at 45°, which remained significantly greater than the intact state. The most significant results were the rotational stability at 90° of hip flexion and coronal plane stability at 0° and 45° of hip flexion, which were significantly improved compared with the capsulectomy state.",2020,"Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes.","['8 paired, fresh-frozen hemi-pelvises (16 hips', '2 Hip Capsular Reconstruction Techniques']","['2 capsular reconstruction techniques (iliotibial band [ITB] graft and Achilles tendon graft', 'ITB or Achilles reconstruction', 'Iliotibial Band Autograft Versus Achilles Tendon Allograft', 'custom-designed joint motion simulator']","['Internal-external rotation (IR-ER) torques and abduction-adduction torques', 'total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes', 'rotational range of motion (ROM', 'total rotation', 'normal rotational ROM', 'medial-lateral translation', 'mean ± SD total rotation', 'rotational stability at 90° of hip flexion and coronal plane stability', 'total abduction-adduction', 'coronal plane stability', 'joint kinematics, restoring rotation and translation to normal values', 'rotational ROM', 'mean medial-lateral translation', 'condition of the hip on the total IR-ER', 'rotational stability']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0225266', 'cui_str': 'Structure of iliotibial tract'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0301196,"Comparisons of the 2 different reconstruction techniques showed no significant differences in total IR-ER or abduction-adduction ROM or joint translation in the coronal, sagittal, or axial planes.","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pasic', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Burkhart', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pardis', 'Initials': 'P', 'LastName': 'Baha', 'Affiliation': 'School of Kinesiology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University Medical Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Degen', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546520962071']
3433,33046115,The effect of breastfeeding education with grandmothers' attendance on breastfeeding self-efficacy and infant feeding pattern in Iranian primiparous women: a quasi-experimental pilot study.,"BACKGROUND


One of the most important factors that affects breastfeeding self-efficacy and exclusivity is breastfeeding support provided by the family. The aim of this study was to determine the effect of breastfeeding education sessions for primiparous women, with and without the attendance of maternal grandmothers, on breastfeeding self-efficacy and infant feeding patterns.
METHODS


This quasi-experimental study was conducted on 64 primiparous women who referred to the Antenatal Clinic of Amiralmomenin Hospital, Tehran, Iran from June to December, 2018. Eligible pregnant women were allocated into two groups; either with and without grandmothers in attendance. Group assignments were determined according to the week the women had prenatal care at the hospital. All eligible women seen in the clinic during 1 week were assigned to one group and women who presented in the alternating week were assigned to the other group. In the education group with grandmothers in attendance, each woman participated in two prenatal education programs with her mother and one postpartum program approximately 3 h before discharge. In the other group, participating mothers attended breastfeeding education sessions without the grandmother's attendance. The participating mothers answered questions from the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) at the time of the hospital discharge, and 4 and 8 weeks after delivery. Questions about the infants' feeding patterns were asked by telephone contact with the participating mothers from both groups at the same time periods.
RESULTS


The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003). No significant difference existed in infant feeding patterns between the groups at the same time periods.
CONCLUSIONS


This study suggests that breastfeeding education with grandmothers' attendance is effective in improving the mothers' breastfeeding self-efficacy. A family-centered program should be considered in beastfeeding education for increasing of exclusive breastfeeding.",2020,"The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003).","['Eligible pregnant women', '64 primiparous women who referred to the Antenatal Clinic of Amiralmomenin Hospital, Tehran, Iran from June to December, 2018', 'Iranian primiparous women', 'primiparous women, with and without the attendance of maternal grandmothers, on breastfeeding self-efficacy and infant feeding patterns', 'All eligible women seen in the clinic during 1 week were assigned to one group and women who presented in the alternating week were assigned to the other group']","[""breastfeeding education with grandmothers' attendance"", 'breastfeeding education sessions']","['infant feeding patterns', 'mean BFSE scores', 'Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1273525', 'cui_str': 'Maternal grandmother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1286340', 'cui_str': 'Infant feeding pattern'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]","[{'cui': 'C1286340', 'cui_str': 'Infant feeding pattern'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",64.0,0.0233771,"The mean BFSE scores were signficantly different between the groups with grandmothers and without grandmothers at the time of the hospital discharge (60.15 ± 4.47 vs. 56.84 ± 6.22, independent t-test; p = 0.017), and at 4 weeks (61.71 ± 2.66 vs. 56.62 ± 9.12, p = 0.004) and 8 weeks after delivery (63.68 ± 2.14 vs. 60.03 ± 6.32, p = 0.003).","[{'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Gharaei', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Amiri-Farahani', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. amirifarahani.l@iums.ac.ir.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, Nursing Care Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Syedeh Batool', 'Initials': 'SB', 'LastName': 'Hasanpoor-Azghady', 'Affiliation': 'Department of Reproductive Health and Midwifery, Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}]",International breastfeeding journal,['10.1186/s13006-020-00325-5']
3434,33048300,Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour?,"Itolizumab is a first-in-class anti-CD6 monoclonal antibody that was initially developed for various cancers and was later developed and approved in India for treatment of moderate to severe chronic plaque psoriasis in 2013. This drug is now being re-purposed for COVID-19. The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use. Subsequently, a phase II, open-label, randomized, placebo-controlled trial has been conducted in 30 COVID-19 patients in India after receiving regulatory permission. Based on the results, the Indian drug regulatory agency recently approved itolizumab in July 2020 for 'restricted emergency use' for the treatment of CRS in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This has drawn sharp criticism within the scientific community, with the approval being granted on the basis of a relatively small phase II trial, without conduct of a conventional phase III trial, and lacking availability of the claimed supportive real-world evidence in the public domain to date. In a global scenario where finding a successful treatment for COVID-19 is of utmost priority, a biologic agent has been re-purposed and approved with a successfully completed RCT, in a country where cases and mortality due to COVID-19 are growing exponentially. However, instead of welcoming the approval with open arms, many doubts are being raised. This is an issue that needs to be considered and dealt with sensitively, as well as scientifically.",2020,"The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use.",['30 COVID-19 patients in India after receiving regulatory permission'],"['itolizumab', 'placebo', 'Itolizumab']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0521104', 'cui_str': 'With permission of'}]","[{'cui': 'C2987424', 'cui_str': 'itolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],30.0,0.048248,"The potential utility of itolizumab in COVID-19, based on its unique mechanism of action in ameliorating cytokine release syndrome (CRS), was proposed first in Cuba with approval of a single-arm clinical trial and expanded access use.","[{'ForeName': 'Shubham', 'Initials': 'S', 'LastName': 'Atal', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India.'}, {'ForeName': 'Zeenat', 'Initials': 'Z', 'LastName': 'Fatima', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India. zeenat.sr2018@aiimsbhopal.edu.in.'}, {'ForeName': 'Sadasivam', 'Initials': 'S', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Pharmacology, All India Institute of Medical Sciences Bhopal, 3rd Floor, Medical College Building, Saket Nagar, Bhopal, 462020, India.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00448-5']
3435,33048619,Molecular Landscape and Actionable Alterations in a Genomically Guided Cancer Clinical Trial: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH).,"PURPOSE


Therapeutically actionable molecular alterations are widely distributed across cancer types. The National Cancer Institute Molecular Analysis for Therapy Choice (NCI-MATCH) trial was designed to evaluate targeted therapy antitumor activity in underexplored cancer types. Tumor biopsy specimens were analyzed centrally with next-generation sequencing (NGS) in a master screening protocol. Patients with a tumor molecular alteration addressed by a targeted treatment lacking established efficacy in that tumor type were assigned to 1 of 30 treatments in parallel, single-arm, phase II subprotocols.
PATIENTS AND METHODS


Tumor biopsy specimens from 5,954 patients with refractory malignancies at 1,117 accrual sites were analyzed centrally with NGS and selected immunohistochemistry in a master screening protocol. The treatment-assignment rate to treatment arms was assessed. Molecular alterations in seven tumors profiled in both NCI-MATCH trial and The Cancer Genome Atlas (TCGA) of primary tumors were compared.
RESULTS


Molecular profiling was successful in 93.0% of specimens. An actionable alteration was found in 37.6%. After applying clinical and molecular exclusion criteria, 17.8% were assigned (26.4% could have been assigned if all subprotocols were available simultaneously). Eleven subprotocols reached their accrual goal as of this report. Actionability rates differed among histologies (eg, > 35% for urothelial cancers and < 6% for pancreatic and small-cell lung cancer). Multiple actionable or resistance-conferring tumor mutations were seen in 11.9% and 71.3% of specimens, respectively. Known resistance mutations to targeted therapies were numerically more frequent in NCI-MATCH than TCGA tumors, but not markedly so.
CONCLUSION


We demonstrated feasibility of screening large numbers of patients at numerous accruing sites in a complex trial to test investigational therapies for moderately frequent molecular targets. Co-occurring resistance mutations were common and endorse investigation of combination targeted-therapy regimens.",2020,"Known resistance mutations to targeted therapies were numerically more frequent in NCI-MATCH than TCGA tumors, but not markedly so.
","['Tumor biopsy specimens from 5,954 patients with refractory malignancies at 1,117 accrual sites were analyzed centrally with NGS and selected immunohistochemistry in a master screening protocol']",[],"['Actionability rates', 'Multiple actionable or resistance-conferring tumor mutations']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",5954.0,0.0605508,"Known resistance mutations to targeted therapies were numerically more frequent in NCI-MATCH than TCGA tumors, but not markedly so.
","[{'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Dana Farber Cancer Institute Boston, MA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Chen', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'ECOG-ACRIN Cancer Research Group Biostatistics Center, Dana Farber Cancer Institute Boston, MA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McShane', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Patton', 'Affiliation': 'Center for Biomedical Informatics and Information Technology, NCI, NIH, Bethesda, MD.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'P Mickey', 'Initials': 'PM', 'LastName': 'Williams', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Iafrate', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sklar', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Lyndsay N', 'Initials': 'LN', 'LastName': 'Harris', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takebe', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sims', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Coffey', 'Affiliation': 'Center for Biomedical Informatics and Information Technology, Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fu', 'Affiliation': 'Frederick National Laboratory for Cancer Research, Frederick, MD.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Routbort', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Zwiebel', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Larry V', 'Initials': 'LV', 'LastName': 'Rubinstein', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Little', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Carlos L', 'Initials': 'CL', 'LastName': 'Arteaga', 'Affiliation': 'University of Texas Southwestern Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Comis', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Philadelphia, PA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Abrams', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Conley', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03010']
3436,32861830,Improving uptake of hepatitis B and hepatitis C testing in South Asian migrants in community and faith settings using educational interventions-A prospective descriptive study.,"BACKGROUND


Chronic viral hepatitis (CVH) is a leading contributor to the UK liver disease epidemic, with global migration from high prevalence areas (e.g., South Asia). Despite international guidance for testing high-risk groups in line with elimination targets, there is no consensus on how to achieve this. The objectives of this study were to assess the following: (1) the feasibility of recruiting South Asian migrants to view an educational film on CVH, (2) the effectiveness of the film in promoting testing and increasing knowledge of CVH, and (3) the methodological issues relevant to scale-up to a randomized controlled trial.
METHODS


South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with dried blood spot CVH testing offered immediately afterwards. Pre/post-film questionnaires assessed the effectiveness of the intervention.
RESULTS


Two hundred and nineteen first-generation migrants ≥18 years of age (53% female) were recruited to view the film at the following sites: religious, n = 112 (51%), community n = 98 (45%), and primary care, n = 9 (4%). One hundred and eighty-four (84%) underwent CVH testing; hepatitis B core antibody or hepatitis C antibody positivity demonstrated exposure in 8.5%. Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
CONCLUSIONS


This study demonstrated the feasibility of recruiting first-generation migrants to view a community-based educational film promoting CVH testing in this higher risk group, confirming the value of developing interventions to facilitate the global World Health Organization plan for targeted case finding and elimination, and a future randomized controlled trial. We highlight the importance of culturally relevant interventions including faith and culturally sensitive settings, which appear to minimize logistical issues and effectively engage minority groups, allowing ease of access to individuals 'at risk'.",2020,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","['Chronic viral hepatitis (CVH', 'South Asian migrants were recruited to view the film (intervention) in community venues (primary care, religious, community), with', 'Two hundred and nineteen first-generation migrants ≥18 years of age (53% female']","['hepatitis B and hepatitis C testing', 'dried blood spot CVH testing offered immediately afterwards', 'CVH testing']",[],"[{'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C2711110', 'cui_str': 'Hepatitis B and hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]",[],,0.0395415,"Pre-intervention (n = 173, 79%) and post-intervention (n = 154, 70%) questionnaires were completed.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Pericleous', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Tushna', 'Initials': 'T', 'LastName': 'Vandrevala', 'Affiliation': 'Department of Psychology, Kingston University, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hendy', 'Affiliation': 'Brunel Business School, Brunel University, London, UK.'}, {'ForeName': 'Shuja', 'Initials': 'S', 'LastName': 'Shafi', 'Affiliation': 'Research and Documentation Committee, The Muslim Council of Britain, London, UK.'}, {'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Skene', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Sumita', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Department of Clinical and Experimental Medicine, Brighton and Sussex Medical School and Department of Gastroenterology and Hepatology, Brighton and Sussex University Hospital, Brighton, UK.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'Institute of Epidemiology and Health Care, UCL, London, UK.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Nicholls', 'Affiliation': 'Public Health England South East, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Gore', 'Affiliation': 'The Hepatitis C Trust, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Royal College of General Practitioners Research and Surveillance Centre, London, UK.'}, {'ForeName': 'Aftab', 'Initials': 'A', 'LastName': 'Ala', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Surrey NHS Foundation Trust, Guildford, Surrey, UK; Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK. Electronic address: aftab.ala1@nhs.net.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.059']
3437,32881622,Essential amino acid supplementation alters the p53 transcriptional response and cytokine gene expression following total knee arthroplasty.,"Reducing muscle atrophy following orthopedic surgery is critical during the postoperative period. Our previous work in patients who underwent total knee arthroplasty (TKA) showed that the vast majority of atrophy occurs within 2 wk following surgery and that essential amino acid (EAA) supplementation attenuates this atrophy. We used RNA-sequencing (RNA-seq) to identify genes associated with atrophy after TKA with and without EAAs. Analysis of overrepresented gene-ontology terms revealed that p53 signaling and the cytokine-cytokine receptor pathways were highly upregulated after TKA. Relative to the placebo group, the EAA group had altered expression of p53 regulators such as  MDM2 . This altered expression may account for differences between groups in timing of upregulation of some p53 targets such as apoptosis genes, and may account for the reduction in muscle loss in the subjects receiving EAAs. Furthermore, we observed altered expression of a large number of cytokine-signaling genes including  TNFRSF12A , which plays a critical role in muscle atrophy, myogenesis, fibrosis, and the noncanonical NF-κB pathway. NEW & NOTEWORTHY  Total knee arthroplasty is the most frequently performed inpatient surgical procedure for those over 45 yr in the United States. Following surgery, patients lose a large amount of muscle, which impacts functional mobility. Previously, our laboratory found that supplementing patients' diets with essential amino acids (EAAs) reduces postsurgical muscle loss. Here, our goal was to characterize the transcriptional changes associated with surgery with and without EAA supplementation to uncover the underlying mechanisms by which EAAs attenuate this muscle loss.",2020,"Relative to the placebo group, the EAA group had altered expression of p53 regulators such as  MDM2 .","['Total knee arthroplasty is the most frequently performed inpatient surgical procedure for those over 45 yr in the United States', 'patients who underwent total knee arthroplasty (TKA', 'total knee arthroplasty']","['EAA', 'placebo', 'essential amino acid (EAA) supplementation', 'Essential amino acid supplementation', 'essential amino acids (EAAs']","['p53 transcriptional response and cytokine gene expression', 'altered expression of p53 regulators such as  MDM2 ', 'p53 signaling and the cytokine-cytokine receptor pathways']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}]","[{'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0971008', 'cui_str': 'MDM2 protein, human'}, {'cui': 'C0206552', 'cui_str': 'Cytokine Receptor'}]",,0.0540947,"Relative to the placebo group, the EAA group had altered expression of p53 regulators such as  MDM2 .","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Muyskens', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Winbush', 'Affiliation': 'Institute of Ecology and Evolution, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Foote', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Turnbull', 'Affiliation': 'Genomics and Cell Characterization Core Facility, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Hans C', 'Initials': 'HC', 'LastName': 'Dreyer', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00022.2020']
3438,33045195,Circulating profile of Activin-Follistatin-Inhibin Axis in women with hypothalamic amenorrhea in response to leptin treatment.,"BACKGROUND


Chronic energy deficiency observed in women that exercise strenuously affects reproductive function, often leading to hypothalamic amenorrhea (HA). In such conditions, hypoleptinemia and robust changes in the Activin-Follistatin-Inhibin Axis (AFI) are observed. Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance. In this work, we aimed to identify differences in hormonal profiles between leptin responders and non-responders among women with HA, with particular focus on the AFI axis.
METHODS


AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ) were measured in blood in: a) An open-label interventional study, b) a randomized placebo-controlled trial, both investigating responders versus non-responders/women with HA treated with leptin.
RESULTS


Women with HA that responded to leptin treatment have higher circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio and a trend to lower AMH compared with non-responders.
CONCLUSIONS


Components of the AFI axis are associated with improvement of reproductive function in women with HA treated with leptin. ΑΜΗ may serve as a marker of ovarian recovery under HA treatment.",2020,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","['women with HA, with particular focus on the AFI axis', 'responders versus non-responders/women with HA treated with leptin', 'women with HA treated with leptin', 'women with hypothalamic amenorrhea in response to leptin treatment']",['placebo'],"['circulating levels/peak values of Inhibin A, Estradiol (E2), higher LH/FSH ratio', 'reproductive function', 'AFI axis and reproductive hormones (LH, FSH, Estradiol, ΑΜΗ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232896', 'cui_str': 'Reproductive function'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}]",,0.0378645,"Treatment with leptin restores menstruation in many (60% responders) but not all (40% non-responders) women, suggesting that leptin is not the only regulator of reproductive function related to energy balance.","[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Bouzoni', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA. Electronic address: ebouzoni@bidmc.harvard.edu.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Perakakis', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA; Section of Endocrinology, VA Boston Healthcare System, Jamaica Plain, MA, USA.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154392']
3439,33045536,Laser tongue debridement for oral malodor-A novel approach to halitosis.,"STUDY OBJECTIVE


Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. We hypothesize that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.
METHODS


A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, Halimeter reading, tongue colors changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.
RESULTS


54 patients recruited with 35 available for follow up. Improvement was observed on all objective and QOL subjective parameters. Treatment was tolerated well with minimal discomfort.
CONCLUSIONS


The tongue is proven to be a major contributor to oral malodor and must be addressed in treatment protocol. LTD significantly reduces malodor by subjective and objective criteria. While impossible to determine whether the tongue serves as a bacterial reservoir or is the origin for oral bacteria it is clear that LTD improves oral hygiene and reduces malodor. LTD is safe and easy to perform. We encourage LTD to be a crucial part of any oral malodor treatment protocol.
TRIAL REGISTRATION


clinical trials, NCT04120948. Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e.",2020,Improvement was observed on all objective and QOL subjective parameters.,"['Registered 25 September 2019 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00098SX&selectaction=Edit&uid=U0000W0Y&ts=51&cx=-elnx7e', '54 patients recruited with 35 available for follow up']","['laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser', 'LTD', 'Laser tongue debridement for oral malodor']","['objective and QOL subjective parameters', 'oral hygiene and reduces malodor']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1839730', 'cui_str': 'Prieto X-linked mental retardation syndrome'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C1289836', 'cui_str': 'Solid-state laser device'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",54.0,0.0383094,Improvement was observed on all objective and QOL subjective parameters.,"[{'ForeName': 'Yosef P', 'Initials': 'YP', 'LastName': 'Krespi', 'Affiliation': 'Northwell Health, United States of America. Electronic address: ykrespi1@northwell.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kizhner', 'Affiliation': ""Mount Sinai St. Luke's, United States of America.""}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Wilson', 'Affiliation': 'Northwell Health, United States of America.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Sivriver', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Biolase, Irvine, CA, United States of America.'}, {'ForeName': 'Yalda', 'Initials': 'Y', 'LastName': 'Khosravi', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stoodley', 'Affiliation': 'Ohio State University, Campus Microscopy and Imaging Facility, Departments of Microbial Infection and Immunity and Orthopaedics, Infectious Diseases Institute, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102458']
3440,33045627,Percutaneous pulsed radiofrequency treatment of dorsal root ganglion for treatment of lumbar facet syndrome.,"OBJECTIVES


Percutaneous radiofrequency denervation of the medial dorsal branch is often used for treatment of chronic low back pain originating from intervertebral facets, which is sometimes associated with a low success rate and a higher incidence of recurrence of pain. We theorized that implementing pulsed radiofrequency treatment to dorsal root ganglion would increase the probability of successful pain relief.
PATIENTS AND METHODS


150 patients diagnosed with CLBP of a confirmed facet origin were included in a prospective randomized controlled trial and were randomly divided into three equal groups, the first was submitted to percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment. Local injection of a mixture of local anesthetic and a steroid was given to the three groups. Cases were followed for a maximum of 3 years.
RESULTS


98 (65.3 %) patients were females. By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63). At 2 years' follow-up, the pulsed radiofrequency treatment of the dorsal root ganglia group maintained significant improvement (p= 0.041) whereas the medial branch denervation group lost its significant effect (p=0.32).By the end of follow-up period, only pulsed radiofrequency treatment of the dorsal root ganglia group kept significant improvement (p=0.044).
CONCLUSION


In CLBP of facet origin, pulsed radiofrequency treatment of the dorsal root ganglia provides both a higher incidence as well as an extended period of pain relief compared to radiofrequency ablation of the medial dorsal branch of the facet joint.",2020,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","['lumbar facet syndrome', '98 (65.3 %) patients were females', '150 patients diagnosed with CLBP of a confirmed facet origin']","['percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment', 'Percutaneous pulsed radiofrequency treatment of dorsal root ganglion', 'mixture of local anesthetic and a steroid']","['VAS', 'probability of successful pain relief']","[{'cui': 'C0458225', 'cui_str': 'Lumbar facet joint pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",150.0,0.0175157,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","[{'ForeName': 'Wael Mohamed', 'Initials': 'WM', 'LastName': 'Moussa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelmmosa@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khedr', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelkhedr2000@yahoo.com.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Elsawy', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, El Menia University, Korneesh El Nil, El Menia, Egypt. Electronic address: medhatelsawy73@yahoo.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106253']
3441,33052103,"Comparison of safety and efficacy between calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution as long-term treatment for scalp psoriasis in Chinese patients: a national, multicentre, prospective, randomized, active-controlled phase 4 trial.","BACKGROUND


The efficacy and safety of calcipotriol plus betamethasone dipropionate gel for the treatment of scalp psoriasis has previously been demonstrated in a four-week trial in a Chinese population.
OBJECTIVE


To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis.
MATERIALS & METHODS


A multicentre, prospective, randomized, active-controlled trial was established in which subjects were randomized (at a ratio of 4:1) to receive either two-compound gel once daily or calcipotriol scalp solution twice daily for 28 weeks. Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated.
RESULTS


A total of 951 subjects were randomly assigned to receive either two-compound gel (n=760) or calcipotriol scalp solution (n=191). The incidence of ADRs was significantly lower in the two-compound gel group compared with the calcipotriol scalp solution group (11.7 vs. 22.2%, p<0.001). There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups. A statistically significant difference in the percentage of visits with treatment success according to the Subject's Global Assessment was observed (p=0.009); more subjects had visits with 100% treatment success (15.2 vs. 6.3%) and fewer subjects had visits with 0% treatment success (23.7 vs. 30.8%) using two-compound gel compared to calcipotriol scalp solution.
CONCLUSION


The two-compound gel was well tolerated and effective in the long-term management of scalp psoriasis in Chinese patients.",2020,"There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups.","['A total of 951 subjects', 'Chinese adult patients with scalp psoriasis', 'Chinese patients', 'scalp psoriasis in Chinese patients']","['two-compound gel once daily or calcipotriol scalp solution', 'calcipotriol plus betamethasone dipropionate gel', 'two-compound gel', 'two-compound gel (n=760) or calcipotriol scalp solution', 'calcipotriol scalp solution', 'calcipotriol plus betamethasone dipropionate gel and calcipotriol scalp solution']","['Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern', 'safety and efficacy', 'incidence of ADRs', 'tolerated and effective', 'treatment-emergent adverse events (TEAEs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis'}]","[{'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",951.0,0.13496,"There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups.","[{'ForeName': 'Lunfei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Ningbo No.2 Hospital, Ningbo, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Shanghai Skin Disease Hospital, Shanghai, China.'}, {'ForeName': 'Guofu', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Chongqing Traditional Chinese Medicine Hospital, Chongqing, China.'}, {'ForeName': 'Qianjin', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'West China Hospital Sichuan University, Chengdu, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Sir Run Run Shaw Hospital (SRRSH) Zhejiang University, School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': ""Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Shuanglin', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Xiuping', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Yayuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}]",European journal of dermatology : EJD,['10.1684/ejd.2020.3876']
3442,33049424,The impact of prior and ongoing threat on the false alarm threshold for facial discrimination.,"BACKGROUND AND OBJECTIVES


Perceptual adaptations that facilitate rapid responses to threats can also lead to false alarms, or the failure to discriminate safe stimuli from signals of threat. We examined the impact of varying degrees of threat on false alarms in the perceptual discrimination of faces along the dimension of emotion (Experiment 1) or identity (Experiment 2).
METHODS


Participants first trained to discriminate between a target and nontarget face. Next, we tested their ability to identify the target in randomized presentations of the target, the nontarget, and nine novel stimuli morphed in 10% increments of similarity from the target to the nontarget. The task was completed under one of three randomized conditions: 1) Ongoing-Threat paired the target with an aversive outcome in both phases; 2) Prior-Threat paired the target with an aversive outcome in the training phase only; and 3) No-Threat paired the target with a neutral outcome in the training phase only.
RESULTS


In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat. In Experiment 2 (N = 90), Ongoing-Threat and Prior-Threat each lowered the false alarm threshold for identity-based discrimination compared to No-Threat.
LIMITATIONS


The experiment did not measure generalization of threat responses.
CONCLUSION


Associating a facial expression or identity with threat leads to faster but less accurate discrimination of faces with similar features, particularly under conditions of ongoing threat. These experiments provide an avenue for examining the parameters that impact false alarms, which play a key role in anxiety disorders.",2021,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.",['Participants first trained to discriminate between a target and nontarget face'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205235', 'cui_str': 'Discriminate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",[],[],,0.0222255,"In Experiment 1 (N = 90), Ongoing-Threat lowered the false alarm threshold for facial discrimination based on anger intensity compared to Prior-Threat and No-Threat.","[{'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'The University of Texas at Austin, USA. Electronic address: spapini@utexas.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dunsmoor', 'Affiliation': 'The University of Texas at Austin, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'The University of Texas at Austin, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101619']
3443,33049433,Selecting the optimal treatment for a depressed individual: Clinical judgment or statistical prediction?,"BACKGROUND


Optimizing treatment selection is a way to enhance treatment success in major depressive disorder (MDD). In clinical practice, treatment selection heavily depends on clinical judgment. However, research has consistently shown that statistical prediction is as accurate - or more accurate - than predictions based on clinical judgment. In the context of new technological developments, the current aim was to compare the accuracy of clinical judgment versus statistical predictions in selecting cognitive therapy (CT) or interpersonal psychotherapy (IPT) for MDD.
METHODS


Data came from a randomized trial comparing CT (n=76) with IPT (n=75) for MDD. Prior to randomization, therapists' recommendations were formulated during multidisciplinary staff meetings. Statistical predictions were based on Personalized Advantage Index models. Primary outcomes were post-treatment and 17-month follow-up depression severity. Secondary outcome was treatment dropout.
RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment. This difference was not found for recommended versus non-recommended treatments based on clinical judgment. Moreover, for individuals with an IPT recommendation by therapists, higher post-treatment and follow-up depression severity was found for those that actually received IPT compared to those that received CT. Recommendations based on statistical prediction and clinical judgment were not associated with differences in treatment dropout.
LIMITATIONS


Information on the clinical reasoning behind therapist recommendations was not collected, and statistical predictions were not externally validated.
CONCLUSIONS


Statistical prediction outperforms clinical judgment in treatment selection for MDD and has the potential to personalize treatment strategies.",2020,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","['n=76) with IPT (n=75) for MDD', 'major depressive disorder (MDD']","['CT', 'IPT', 'cognitive therapy (CT) or interpersonal psychotherapy (IPT']","['treatment dropout', 'post-treatment and 17-month follow-up depression severity']","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0030686', 'cui_str': 'Patient Dropouts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",76.0,0.0177431,"RESULTS


Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands. Electronic address: suzanne.vanbronswijk@maastrichtuniversity.nl.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, 3720 Walnut Street, Philadelphia, PA 19104-6241, USA.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.135']
3444,33049434,Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder.,"BACKGROUND


Little is known about the the acute effects of cannabis on symptoms of OCD in humans. Therefore, this study sought to: 1) examine whether symptoms of OCD are significantly reduced after inhaling cannabis, 2) examine predictors (gender, dose, cannabis constituents, time) of these symptom changes and 3) explore potential long-term consequences of repeatedly using cannabis to self-medicate for OCD symptoms, including changes in dose and baseline symptom severity over time.
METHOD


Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time. Specifically, data were analyzed from 87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months.
RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis. Higher concentrations of CBD and higher doses predicted larger reductions in compulsions. The number of cannabis use sessions across time predicted changes in intrusions, such that later cannabis use sessions were associated with smaller reductions in intrusions. Baseline symptom severity and dose remained fairly constant over time.
LIMITATIONS


The sample was self-selected, self-identified as having OCD, and there was no placebo control group.
CONCLUSIONS


Inhaled cannabis appears to have short-term beneficial effects on symptoms of OCD. However, tolerance to the effects on intrusions may develop over time.",2020,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","['87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months', 'Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time']",['Cannabis'],"['Symptoms of Obsessive-Compulsive Disorder', 'anxiety', 'compulsions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}]",,0.034413,"RESULTS


Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","[{'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Mauzay', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.124']
3445,33049455,The effectiveness of brief animated films as a scalable micro-intervention to improve children's body image: A randomised controlled trial.,"Creating media to counteract the plethora of media and advertising that perpetuates negative body image is a scalable public health strategy that can be achieved through innovative micro-interventions. This study examined the immediate and short-term (one-week follow-up) impact of viewing brief, evidence-informed animated films on young people's body image, media literacy, and self-efficacy in addressing appearance teasing. The animations were co-created through a partnership among academics, a personal care brand's social mission, and a children's television channel. Participants aged 7-14 (N = 1329, 49 % girls) were randomised into one of three viewing conditions: Appearance Teasing & Bullying, Media & Celebrities, or a non-appearance-related animation. Contrary to predictions, all three animations were comparably effective at eliciting intervention effects. For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up. Findings indicate that children's media is an effective medium for developing micro-interventions.",2020,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","['Participants aged 7-14 (N = 1329, 49 % girls', ""children's body image""]","['viewing brief, evidence-informed animated films']","['state body satisfaction', 'trait media literacy', 'sensitivity to appearance teasing']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C4721445', 'cui_str': 'Teasing'}]",,0.0220831,"For girls and boys aged 7-10, all three animations immediately improved state body satisfaction (+boys aged 11-14; Cohen's ds = .60-.71) and led to sustained improvements in trait media literacy (+girls aged 11-14; ds = .38-.61), sensitivity to appearance teasing (+boys aged 11-14; ds = .35-.48), and willingness to ignore appearance teasing (7-10 years only; ds = .34-.74) at one-week follow-up.","[{'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Matheson', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK. Electronic address: emily.matheson@uwe.ac.uk.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lewis-Smith', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}, {'ForeName': 'Phillippa C', 'Initials': 'PC', 'LastName': 'Diedrichs', 'Affiliation': 'Centre for Appearance Research, Department of Health and Social Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK.'}]",Body image,['10.1016/j.bodyim.2020.08.015']
3446,33052785,"Re: Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Women, a Randomized Clinical Trial.",,2020,,[],['Individual Pelvic Floor Muscle Training'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]",[],,0.0714689,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001286.02']
3447,33052786,"Re: Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo.",,2020,,"['Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or']","['Mirabegron', 'Placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.184078,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001286']
3448,33052965,"The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD.","BACKGROUND


Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown.
METHODS AND FINDINGS


To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer's perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25-40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of $103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $7.6 million while generating 288 QALYS, or $26,427 per QALY gained.
CONCLUSION


MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.",2020,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","['patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP', 'Chronic posttraumatic stress disorder (PTSD', '105 subjects; and a four-year follow-up of 19 subjects']","['MDMA-assisted psychotherapy', '3,4-methylenedioxymethamphetamine', 'MDMA-assisted psychotherapy (MAP', 'inactive placebo']","['medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio', 'Efficacy', 'medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0346378,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","[{'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Marseille', 'Affiliation': 'Health Strategies International, Oakland, California, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0239997']
3449,33053048,The effect of prophylactic rewarming on postoperative nausea and vomiting among patients undergoing laparoscopic hysterectomy: a prospective randomized clinical study.,"BACKGROUND


Postoperative nausea and vomiting (PONV) is a common complication from general anesthesia that impacts on postoperative recovery.
OBJECTIVE


To evaluate prophylactic rewarming following general anesthesia, so as to decrease the incidence of PONV among patients undergoing laparoscopic hysterectomy.
DESIGN AND SETTING


Prospective randomized clinical study at a hospital in China.
METHODS


Sixty-two patients were randomly assigned into two groups. The forced air warming (FAW) group received pre-warmed Ringer's solution with FAW until the end of surgery. The control group received Ringer's solution without FAW. The pre-warmed Ringer's solution was stored in a cabinet set at 40 °C. The FAW tube was placed beside the patient's shoulder with a temperature of 43 °C.
RESULTS


Sixty patients completed the study. The FAW group showed significant differences versus the controls regarding temperature. At 6, 24 and 48 hours postoperatively, the incidences of PONV were 53.3%, 6.7% and 3.3% in the FAW group versus 63.3%, 30% and 3.3% in the controls. VAS scores were significantly lower in the FAW group than in the controls at 24 hours (P= 0.035). Forty-item questionnaire total scores in the FAW group were significantly higher than in the controls. The physical independence and pain scores at 24 hours and emotional support and pain scores at 48 hours in the FAW group were higher than in the controls (P < 0.05). There was no difference in hemodynamics or demographics between the two groups (P > 0.05).
CONCLUSIONS


Prophylactic rewarming relieved PONV and improved the quality of postoperative recovery.
CHINESE CLINICAL TRIAL REGISTER (CHICTR)


ChiCTR-IOR-17012901.",2020,VAS scores were significantly lower in the FAW group than in the controls at 24 hours (P= 0.035).,"['patients undergoing laparoscopic hysterectomy', 'Sixty-two patients', 'Prospective randomized clinical study at a hospital in China', 'Sixty patients completed the study']","['prophylactic rewarming', ""forced air warming (FAW) group received pre-warmed Ringer's solution with FAW"", ""Ringer's solution without FAW"", 'FAW']","['VAS scores', 'postoperative nausea and vomiting', 'Forty-item questionnaire total scores', 'quality of postoperative recovery', 'hemodynamics or demographics', 'physical independence and pain scores at 24 hours and emotional support and pain scores', 'incidence of PONV', 'incidences of PONV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206156', 'cui_str': 'Rewarming'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",62.0,0.0653324,VAS scores were significantly lower in the FAW group than in the controls at 24 hours (P= 0.035).,"[{'ForeName': 'DongDong', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': 'MD. Anesthesiologist, Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Ouhai Area, Wenzhou City, Zhejiang Province, China.'}, {'ForeName': 'YuanLu', 'Initials': 'Y', 'LastName': 'Shan', 'Affiliation': 'MD. Anesthesiologist, Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Ouhai Area, Wenzhou City, Zhejiang Province, China.'}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'MD. Anesthesiologist, Department of Anesthesiology, The First Affiliated Hospital of Wenzhou Medical University, Ouhai Area, Wenzhou City, Zhejiang Province, China.'}]",Sao Paulo medical journal = Revista paulista de medicina,['10.1590/1516-3180.2020.0059.R2.06072020']
3450,33053084,Immediate effects of semi-occluded vocal tract exercises in low and high voices: a self-perception study.,"PURPOSE


To investigate the self-perception by individuals on the immediate effects of three semi-occluded vocal tract exercises (SOVTE), that is, phonation into a latex tube, finger kazoo and phonation into a high-resistance straw, and to compare the self-perception results between the high and low voice groups.
METHOD


The study participants consisted of 26 choristers (seven sopranos, seven altos, six tenors, and six basses) subdivided into high and low voices with ages ranging from 18 to 58 years. Voice samples of each subject were recorded before and after performing the exercises randomly for three subsequent weeks. A self-assessment questionnaire was applied.
RESULTS


All exercises had a statistically significant improvement, according to the participants' self-perception. Latex tube phonation was the preferred technique for 11 (84.62%) participants in the low voice group; while the high-resistance straw was reported as the less beneficial exercise by 10 (79.92%) participants in the same group. On the other hand, the high-resistance straw (9; 69.2%) was the preferred exercise for the high voice group; while finger kazoo (6; 46.15%) and latex tube (5; 38.4%) were the least beneficial exercises.
CONCLUSION


The study showed that the effects of these exercises are different and should be suited for each type of voice, such as the latex tube, which was the most preferred by low voice participants and also rated as less beneficial by high voice participants, and the high-resistance straw, which was the most preferred by the high voice participants and also rated as less beneficial by low voice participants.",2020,Latex tube phonation was the preferred technique for 11 (84.62%) participants in the low voice group; while the high-resistance straw was reported as the less beneficial exercise by 10 (79.92%) participants in the same group.,"['low and high voices', 'participants consisted of 26 choristers (seven sopranos, seven altos, six tenors, and six basses) subdivided into high and low voices with ages ranging from 18 to 58 years']","['three semi-occluded vocal tract exercises (SOVTE', 'semi-occluded vocal tract exercises']","['beneficial exercise', 'Latex tube phonation']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0004830', 'cui_str': 'Bass'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023115', 'cui_str': 'Latex'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}]",,0.0123555,Latex tube phonation was the preferred technique for 11 (84.62%) participants in the low voice group; while the high-resistance straw was reported as the less beneficial exercise by 10 (79.92%) participants in the same group.,"[{'ForeName': 'Diego Henrique da Cruz', 'Initials': 'DHDC', 'LastName': 'Martinho', 'Affiliation': 'Departamento de Desenvolvimento Humano e Reabilitação da Faculdade de Ciências Médicas da Universidade Estadual de Campinas - UNICAMP - Campinas (SP), Brasil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Constantini', 'Affiliation': 'Departamento de Desenvolvimento Humano e Reabilitação da Faculdade de Ciências Médicas da Universidade Estadual de Campinas - UNICAMP - Campinas (SP), Brasil.'}]",CoDAS,['10.1590/2317-1782/20202019079']
3451,33053431,"Medical assistant health coaching (""MAC"") for type 2 diabetes in diverse primary care settings: A pragmatic, cluster-randomized controlled trial protocol.","In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. ""Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching."" While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world, primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings - A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability.",2020,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","['eligible patients at both health systems', 'individuals with diabetes. ', 'diabetes clinical control among N\u202f=\u202f600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California']","['Medical Assistant Health Coaching', 'MA health coaching versus usual care', 'Medical assistant health coaching (""MAC']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}]",[],,0.0371121,"Team-based"" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or ""health coaching.""","[{'ForeName': 'Addie L', 'Initials': 'AL', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Fortmann.Adelaide@scrippshealth.org.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'Johanna A', 'Initials': 'JA', 'LastName': 'Euyoque', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Euyoque.Johanna@scrippshealth.org.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Clark', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: tlclark@sdsu.edu.'}, {'ForeName': 'Daniela G', 'Initials': 'DG', 'LastName': 'Vital', 'Affiliation': 'San Diego State University Research Foundation, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: dvital@sdsu.edu.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Sandoval', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Sandoval.Haley@scrippshealth.org.'}, {'ForeName': 'Julia I', 'Initials': 'JI', 'LastName': 'Bravin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: jbravin-w@sdsu.edu.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Savin', 'Affiliation': 'San Diego State University/ University of California, San Diego Joint Doctoral Program in Clinical Psychology, 5500 Campanile Dr, San Diego, CA 92182 / 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: ksavin@sdsu.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Jones', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, 10140 Campus Point Drive, Suite 200, San Diego, CA 92121, USA. Electronic address: Jones.Jennifer2@scrippshealth.org.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Roesch', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: sroesch@sdsu.edu.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Gilmer', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States of America. Electronic address: tgilmer@ucsd.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodenheimer', 'Affiliation': 'Department of Family and Community Medicine, University of California at San Francisco School of Medicine, 533 Parnassus Ave, San Francisco, CA 94143, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Neighborhood Healthcare, 460 N Elm St, Escondido, CA 92025, USA. Electronic address: jims@nhcare.org.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Gallo', 'Affiliation': 'Department of Psychology, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, USA. Electronic address: lgallo@sdsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106164']
3452,33063953,Acute beetroot juice supplementation improves exercise tolerance and cycling efficiency in adults with obesity.,"BACKGROUND


Exercise training improves health outcomes in individuals with obesity (IO); however, it remains challenging for IO to adhere to exercise. Thus, it is critical to identify novel strategies that improve exercise tolerance (ET) and adherence in IO. Beetroot juice (BRJ), high in inorganic dietary nitrate, consistently improves exercise performance in athletes, individuals with cardiopulmonary diseases, and nonobese lean individuals. These improvements may be explained by reduced oxygen uptake (VO 2  ) during exercise, enhanced blood flow, and greater mitochondrial efficiency. To date, we are aware of no studies that have compared the effects of BRJ, sodium nitrate (NaNO3), and nitrate-depleted BRJ (PLA) for improving ET and cardiometabolic health in IO.
PURPOSE


Determine if BRJ improves ET, exercise efficiency (EE), and cardiometabolic health in IO and identify possible mechanisms of action.
METHODS


Vascular hemodynamic, submaximal- and maximal-exercise VO 2  , and time to exhaustion (TTE) were assessed in 16 participants 2.5 hr following consumption of: 1) BRJ, 2) NaNO 3  , 3) PLA, or 4) CON.
RESULTS


A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001). Post hoc analyses revealed lower VO 2  during submaximal exercise in BRJ compared to PLA (p = .009) NaNO3 (p = .042) and CON (0.009), equating to an average improvement of ~ 7% with BRJ. TTE was greater for BRJ compared to other treatment arms, PLA (p = .008), NaNO3 (p = .038), and CON (p=<0.001), equating to ~ 15% improvement with BRJ. No significant changes were observed for other outcomes.
CONCLUSIONS


Consumption of BRJ improved EE during submaximal exercise by 7%, and TTE by 15% compared to other conditions. These results suggest that BRJ may improve EE and exercise tolerance in IO.",2020,"A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001).","['adults with obesity', 'athletes, individuals with cardiopulmonary diseases, and nonobese lean individuals', '16 participants 2.5\xa0hr following consumption of: 1) BRJ, 2) NaNO 3  , 3) PLA, or 4) CON', 'individuals with obesity (IO']","['Exercise training', 'Beetroot juice (BRJ), high in inorganic dietary nitrate', 'BRJ, sodium nitrate (NaNO3), and nitrate-depleted BRJ (PLA', 'Acute beetroot juice supplementation', 'BRJ']","['exercise tolerance and cycling efficiency', 'exercise tolerance (ET) and adherence', 'Vascular hemodynamic, submaximal- and maximal-exercise VO 2  , and time to exhaustion (TTE', 'oxygen uptake (VO 2  ) during exercise, enhanced blood flow, and greater mitochondrial efficiency', 'health outcomes', 'EE and exercise tolerance', 'NaNO3', 'ET, exercise efficiency (EE), and cardiometabolic health', 'submaximal exercise VO 2', 'exercise performance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",16.0,0.0309602,"A significant treatment effect was observed for submaximal exercise VO 2  (p = .003), and TTE (p < .001).","[{'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Behrens', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Khandaker', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Ricart', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Braxton', 'Initials': 'B', 'LastName': 'Linder', 'Affiliation': 'Department of Human Studies, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernández', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Bertrand', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rakesh P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Center for Free Radical Biology, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': 'Department of Human Studies, The University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Physiological reports,['10.14814/phy2.14574']
3453,33049927,Effect of an Ergonomics Educational Program on Musculoskeletal Disorders in Nursing Staff Working in the Operating Room: A Quasi-Randomized Controlled Clinical Trial.,"Background:  Nursing staff working in the operating room are exposed to risk factors that can cause musculoskeletal disorders (MSDs) and work-related disabilities. The use of ergonomics principles can help with the prevention of MSDs. This study aimed to examine the effect of an ergonomics educational program on MSDs among nursing staff working in the operating room.  Methods:  In this pragmatic parallel group quasi-randomized controlled clinical trial, 74 nursing staff working in the operating rooms of two teaching hospitals participated. The hospitals were randomly assigned to either the intervention or the control group and all nursing staff working in the operating room of each hospital were invited to take part in this research. They were initially assessed for the prevalence and risk of MSDs by using the Nordic questionnaire and the rapid entire body assessment (REBA) checklist. The intervention group received the ergonomics educational program and were assessed in two-week intervals over a period of three months. At the end of the study, the risk and prevalence of MSDs were compared between the intervention and control groups.  Results:  Statistically significant differences were reported between the groups in terms of the prevalence and risk of MSDs. The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03). The reduction in the prevalence of MSDs in the different parts of the body in the intervention group was as follows: ankle ( p  = 0.005), hand/wrist ( p  = 0.041), low back ( p  = 0.000), the neck ( p  = 0.003), hip ( p  = 0.001) and shoulder ( p  = 0.043).  Conclusion:  The education of nursing staff about ergonomics can influence the prevalence and risk of MSDs. Therefore, it should be incorporated into the degree education and on-the-job training initiatives for nurses working in the operating theatre in order to reduce workplace injuries and associated absences, and increase the quality of care delivered by them. This clinical trial has been registered in the Iranian Registry of Clinical Trials: IRCT2015081823677N1.",2020,The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03).,"['74 nursing staff working in the operating rooms of two teaching hospitals participated', 'Musculoskeletal Disorders in Nursing Staff Working in the Operating Room']","['control group and all nursing staff working', 'Ergonomics Educational Program', 'ergonomics educational program']","['prevalence and risk of MSDs by using the Nordic questionnaire and the rapid entire body assessment (REBA) checklist', 'risk and prevalence of MSDs', 'prevalence and risk of MSDs', 'prevalence of MSDs', 'overall risk of MSDs']","[{'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0268263', 'cui_str': 'Multiple sulfatase deficiency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",74.0,0.0344032,The overall risk of MSDs decreased in the intervention group after the educational program ( p  = 0.03).,"[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Abdollahi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran 1419733171, Iran.'}, {'ForeName': 'Shadan', 'Initials': 'S', 'LastName': 'Pedram Razi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran 1419733171, Iran.'}, {'ForeName': 'Daryoush', 'Initials': 'D', 'LastName': 'Pahlevan', 'Affiliation': 'Social Determinants of Health Research Centre, Semnan University of Medical Sciences, Semnan 3514799422, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran 1417613151, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Amaniyan', 'Affiliation': 'Student Research Center, Semnan University of Medical Sciences, Semnan 3514799422, Iran.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leibold Sieloff', 'Affiliation': 'College of Nursing, Montana State University, Bozeman, MT 172220, USA.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17197333']
3454,33050038,The Role of the Teacher in the Implementation of a School-Based Intervention on the Physical Activity Practice of Children.,"Medium- or long-term intervention strategies for physical activity practice (PAP) need to be more effective in terms of their implementation by practitioners. The aim of this study was to evaluate the role of a teacher to implement the Team Pentathlon (TP) in order to improve the PAP in primary children. TP is a health education program made to improve PAP of children through individual and collective achievements. In this study, 203 children (age: 10-13 years) in grades 5 and 6 (intervention group (IG)  N  = 104, control group (CG)  N  = 99) were guided to increase their PAP during an eight-week period by five elementary school teachers (physical education or classroom) who had received four training sessions. Levels of PAP (self-reported) were compared between groups (IG/CG), sex, socioeconomic status of the schools and between teachers: baseline and during TP. Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP. One teacher even observed higher PAP in the CG. Training session records revealed that the teacher himself, how the TP is implemented, and proper resources were the three elements that explained the successful implementation of the TP program. The implementation of the TP significantly increased the PAP in primary children. Training sessions helped teachers to implement the TP program but personal engagement, motivation, respecting protocol, and an adequate environment are also necessary in improving the PAP of children.",2020,"Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP.","['primary children', 'Children', '203 children (age: 10-13 years) in grades 5 and 6 (intervention group (IG)  N  = 104, control group (CG)  N  = 99) were']","['guided to increase their PAP during an eight-week period by five elementary school teachers (physical education or classroom) who had received four training sessions', 'Team Pentathlon (TP']","['Levels of PAP (self-reported', 'PAP']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0870482', 'cui_str': 'Elementary School Teachers'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205450', 'cui_str': '4'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",203.0,0.0103558,"Several teachers noted significant increases in PAP in the IG for both boys and girls ( p  ≤ 0.05 or  p  < 0.01), whereas others found only small improvements in PAP.","[{'ForeName': 'Tegwen', 'Initials': 'T', 'LastName': 'Gadais', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Caron', 'Affiliation': ""Faculté des Sports et de l'EP, Université d'Artois, 62800 Liévin, France.""}, {'ForeName': 'Marie-Belle', 'Initials': 'MB', 'LastName': 'Ayoub', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Karelis', 'Affiliation': 'Department of Physical Activity Sciences, University of Quebec in Montreal, Montreal, QC H3C 3P8, Canada.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Nadeau', 'Affiliation': 'Department of Physical Education, Laval University, Quebec City, QC G1V 0A6, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17197344']
3455,33052809,Effect of an Aerosol Box on Intubation in Simulated Emergency Department Airways: A Randomized Crossover Study.,"INTRODUCTION


The use of transparent plastic aerosol boxes as protective barriers during endotracheal intubation has been advocated during the severe acute respiratory syndrome coronavirus 2 pandemic. There is evidence of worldwide distribution of such devices, but some experts have warned of possible negative impacts of their use. The objective of this study was to measure the effect of an aerosol box on intubation performance across a variety of simulated difficult airway scenarios in the emergency department.
METHODS


This was a randomized, crossover design study. Participants were randomized to intubate one of five airway scenarios with and without an aerosol box in place, with randomization of intubation sequence. The primary outcome was time to intubation. Secondary outcomes included number of intubation attempts, Cormack-Lehane view, percent of glottic opening, and resident physician perception of intubation difficulty.
RESULTS


Forty-eight residents performed 96 intubations. Time to intubation was significantly longer with box use than without (mean 17 seconds [range 6-68 seconds] vs mean 10 seconds [range 5-40 seconds], p <0.001). Participants perceived intubation as being significantly more difficult with the aerosol box. There were no significant differences in the number of attempts or quality of view obtained.
CONCLUSION


Use of an aerosol box during difficult endotracheal intubation increases the time to intubation and perceived difficulty across a range of simulated ED patients.",2020,"Time to intubation was significantly longer with box use than without (mean 17 seconds [range 6-68 seconds] vs mean 10 seconds [range 5-40 seconds], p <0.001).","['Simulated Emergency Department Airways', 'Forty-eight residents performed 96 intubations']","['five airway scenarios with and without an aerosol box in place, with randomization of intubation sequence', 'aerosol box', 'transparent plastic aerosol boxes', 'Aerosol Box']","['Time to intubation', 'time to intubation', 'number of intubation attempts, Cormack-Lehane view, percent of glottic opening, and resident physician perception of intubation difficulty', 'number of attempts or quality of view obtained']","[{'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]",,0.239228,"Time to intubation was significantly longer with box use than without (mean 17 seconds [range 6-68 seconds] vs mean 10 seconds [range 5-40 seconds], p <0.001).","[{'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Turner', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Falvo', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Rami A', 'Initials': 'RA', 'LastName': 'Ahmed', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Ellender', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Corson-Knowles', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Bona', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Elisa J', 'Initials': 'EJ', 'LastName': 'Sarmiento', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Dylan D', 'Initials': 'DD', 'LastName': 'Cooper', 'Affiliation': 'Indiana University School of Medicine, Department of Emergency Medicine, Indianapolis, Indiana.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.8.48901']
3456,33052903,Validation of the Unesp-Botucatu composite scale to assess acute postoperative abdominal pain in sheep (USAPS).,"A scale with robust statistical validation is essential to diagnose pain and improve decision making for analgesia. This blind, randomised, prospective and opportunist study aimed to develop an ethogram to evaluate behaviour and validate a scale to assess acute ovine postoperative pain. Elective laparoscopy was performed in 48 healthy sheep, filmed at one preoperative and three postoperative moments, before and after rescue analgesia and 24 hours after. The videos were randomised and assessed twice by four evaluators, with a one-month interval between evaluations. Statistical analysis was performed using R software and differences were considered significant when p <0.05. Based on the multiple association, a unidimensional scale was adopted. The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53). The scale presented Spearman correlations > 0.80 with the numerical, simple descriptive, and visual analogue scales, and a correlation of 0.48 with the facial expression scale. According to the mixed linear model, the scale was responsive, due to the increase and decrease in pain scores of all items after surgery and analgesic intervention, respectively. All items on the scale demonstrated an acceptable Spearman item-total correlation (0.56-0.76), except for appetite (0.25). The internal consistency was excellent (Cronbach's α = 0.81) and all items presented specificity > 0.72 and sensitivity between 0.61-0.90, except for appetite. According to the Youden index, the cut-off point was ≥ 4 out of 12, with a diagnostic uncertainty zone of 4 to 5. The area under the curve > 0.95 demonstrated the excellent discriminatory capacity of the instrument. In conclusion, the Unesp-Botucatu pain scale in sheep submitted to laparoscopy is valid, reliable, specific, sensitive, with excellent internal consistency, accuracy, discriminatory capacity, and a defined cut-off point.",2020,The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53).,"['48 healthy sheep', 'sheep (USAPS']",['Elective laparoscopy'],"['Unesp-Botucatu pain scale', 'facial expression scale', 'pain scores']","[{'cui': 'C0036945', 'cui_str': 'Genus Ovis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",48.0,0.0194405,The intra- and inter-observer reliability ranged from moderate to very good (intraclass correlation coefficient ≥ 0.53).,"[{'ForeName': 'Nuno Emanuel Oliveira Figueiredo', 'Initials': 'NEOF', 'LastName': 'Silva', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Pedro Henrique Esteves', 'Initials': 'PHE', 'LastName': 'Trindade', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Alice Rodrigues', 'Initials': 'AR', 'LastName': 'Oliveira', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Marilda Onghero', 'Initials': 'MO', 'LastName': 'Taffarel', 'Affiliation': 'Department of Veterinary Medicine, State University of Maringá, Umuarama, Paraná, Brazil.'}, {'ForeName': 'Maria Alice Pires', 'Initials': 'MAP', 'LastName': 'Moreira', 'Affiliation': 'Goiano Federal Institute, Urutaí Campus, Department of Veterinary Medicine, Urutaí, GO, Brazil.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Denadai', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Paula Barreto', 'Initials': 'PB', 'LastName': 'Rocha', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Stelio Pacca Loureiro', 'Initials': 'SPL', 'LastName': 'Luna', 'Affiliation': 'Department of Veterinary Surgery and Animal Reproduction, School of Veterinary Medicine and Animal Science, São Paulo State University (Unesp), Botucatu, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0239622']
3457,33052906,Association between behavioral phenotypes and response to a physical activity intervention using gamification and social incentives: Secondary analysis of the STEP UP randomized clinical trial.,"Participants often vary in their response to behavioral interventions, but methods to identify groups of participants that are more likely to respond are lacking. In this secondary analysis of a randomized clinical trial, we used baseline characteristics to group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention. Latent class analysis was used to segment participants based on baseline participant data including demographics, validated measures of psychosocial variables, and physical activity behavior. The trial included 602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three gamification interventions (supportive, collaborative, or competitive) to increase physical activity. Daily step counts were monitored using a wearable device for a 24-week intervention with 12 weeks of follow-up. The model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk. Adjusted regression models were used to test for differences in intervention response relative to control within each behavioral phenotype. In Class 1, only participants in the competitive arm increased their mean daily steps during the intervention (adjusted difference, 945; 95% CI, 352-1537; P = .002), but it was not sustained during follow-up. In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up. In Class 3, none of the interventions had a significant effect on physical activity. Three behavioral phenotypes were identified, each with a different response to the interventions. This approach could be used to better target behavioral interventions to participants that are more likely to respond to them.",2020,"In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up.","['group participants into distinct behavioral phenotypes and evaluated differential responses to a physical activity intervention', 'model segmented participants into three classes named for key defining traits: Class 1, extroverted and motivated; Class 2, less active and less social; Class 3, less motivated and at-risk', '602 adults from 40 U.S. states with body mass index ≥25 who were randomized to control or one of three']","['physical activity intervention', 'gamification interventions (supportive, collaborative, or competitive']","['mean daily steps', 'physical activity']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321146', 'cui_str': 'Behavioral phenotype'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",602.0,0.0609845,"In Class 2, participants in all three gamification arms significantly increased their mean daily steps compared to control during the intervention (supportive arm adjusted difference 1172; 95% CI, 363-1980; P = .005; collaborative arm adjusted difference 1119; 95% CI, 319-1919; P = .006; competitive arm adjusted difference 1179; 95% CI, 400-1957; P = .003) and all three had sustained impact during follow-up.","[{'ForeName': 'Xisui Shirley', 'Initials': 'XS', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Changolkar', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Amol S', 'Initials': 'AS', 'LastName': 'Navathe', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Linn', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reh', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Szwartz', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steier', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Godby', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Balachandran', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Harrison', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennyslvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, University of Pennyslvania Perelman School of Medicine, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0239288']
3458,33063323,Lost in translation: true clinical impact of reflectance confocal microscopy overlooked in 'Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial': reply from authors.,,2020,"We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study.","['1,2', 'patients with clinically suspected primary basal cell carcinoma (BCC']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C4721806', 'cui_str': 'Basal cell carcinoma of skin'}]",[],[],,0.0346012,"We agree on the importance to determine the place of reflectance confocal microscopy (RCM) as a diagnostic tool in real-world clinical practice, which is why we originally initiated our study.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Woliner-van der Weg', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peppelman', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'P E J', 'Initials': 'PEJ', 'LastName': 'van Erp', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'S F K', 'Initials': 'SFK', 'LastName': 'Lubeek', 'Affiliation': 'Department of Dermatology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.19605']
3459,33063397,Differential effects of visually induced analgesia and attention depending on the pain stimulation site.,"BACKGROUND


The term 'visually induced analgesia' describes a reduced pain perception induced by watching the painful body part as opposed to watching a neutral object. In chronic back pain patients, experimental pain, movement-induced pain and habitual pain can be reduced with visual feedback. Visual feedback can also enhance the effects of both massage treatment and manual therapy. The impact of somatosensory attentional processes remains unclear.
METHODS


In the current study, participants received painful electrical stimuli to their thumb and back while being presented with either a real-time video of their thumb or back (factor feedback). In addition, using an oddball paradigm, they had to count the number of deviant stimuli, applied to either their back or thumb (factor attention) and rate the pain intensity.
RESULTS


We found a significant main effect for attention with decreased pain ratings during attention. There was no main effect for visual feedback and no significant interaction between visual feedback and attention. Post-hoc tests revealed that the lowest pain intensity ratings were achieved during visual feedback of the back/ thumb and counting at the back/ thumb.
CONCLUSION


These data suggest that the modulation of perceived acute pain by visually induced analgesia may be influenced by a simultaneous somatosensory attention task.
SIGNIFICANCE


Somatosensory attention reduced experimental pain intensity in the thumb and back in the presence of both congruent and incongruent visual feedback. We found no significant visual feedback effect on the complex interplay between visual feedback and somatosensory attention.",2020,"In chronic back pain patients, experimental pain, movement-induced pain and habitual pain can be reduced with visual feedback.",[],['painful electrical stimuli to their thumb and back while being presented with either a real-time video of their thumb or back (factor feedback'],"['pain ratings', 'visual feedback effect', 'experimental pain intensity', 'experimental pain, movement-induced pain and habitual pain', 'lowest pain intensity ratings', 'visual feedback', 'pain perception']",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",,0.0417368,"In chronic back pain patients, experimental pain, movement-induced pain and habitual pain can be reduced with visual feedback.","[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Cordier', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Ullrich', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Herpertz', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Zieglgänsberger', 'Affiliation': 'Department of Clinical Neuropharmacology, Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Diers', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, LWL University Hospital, Ruhr University Bochum, Bochum, Germany.'}]","European journal of pain (London, England)",['10.1002/ejp.1676']
3460,33060126,Effect of BATHE interview technique on patient satisfaction in an ambulatory family medicine centre in South India.,"OBJECTIVE


The objective of the study is to determine the effect of background, affect, trouble, handling and empathy (BATHE) versus usual interview technique on patient satisfaction during regular consultation with family physicians in ambulatory care.
DESIGN


The research design was a prospective, randomised control trial.
SETTING


The trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital.
PARTICIPANT


The eligible participants were adults above the age of 18 years, who did not have any acute presenting illness. The participants should have given consent and also not have any cognitive disability. A total of 138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group. All participants entering the trial completed the questionnaire.
RESULT


The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction. This included questions on whether the patient felt that the physician treated them as a person and also whether they felt the appropriate clinical examination was communicated to them. The questionnaire used for scoring satisfaction had 18 questions with a maximum possible score of 90. When taking a cut-off of 75% (68) from the total possible score of 90, 72.9% (51) of the participants for whom the BATHE consultation technique was used were satisfied as compared with only 55.9% (30) for whom the routine consultation was carried out. This was statistically significant (χ 2 =11.15, p value=0.0006) CONCLUSION: The study suggests that using BATHE in this family practice centre is beneficial in improving the perception of person centeredness in the consultation. However, further studies ruling out all possible bias are needed in our setting before the range of probable benefits of the BATHE technique can be fully gauged.",2020,The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction.,"['The trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital', 'patient satisfaction in an ambulatory family medicine centre in South India', 'eligible participants were adults above the age of 18 years, who did not have any acute presenting illness', 'patient satisfaction during regular consultation with family physicians in ambulatory care', '138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group']",['usual interview technique'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],138.0,0.0481547,The BATHE group had a significantly higher mean score for questions grouped under professional satisfaction.,"[{'ForeName': 'Navnee', 'Initials': 'N', 'LastName': 'Chengappa', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Prince Christopher', 'Initials': 'PC', 'LastName': 'Rajkumar Honest', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India prince.christopher@gmail.com.'}, {'ForeName': 'Kirubah', 'Initials': 'K', 'LastName': 'David', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Ruby Angeline', 'Initials': 'RA', 'LastName': 'Pricilla', 'Affiliation': 'Department of Community Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Sajitha Mf', 'Initials': 'SM', 'LastName': 'Rahman', 'Affiliation': 'Department of Family Medicine, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Rebecca', 'Affiliation': 'Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India.'}]",Family medicine and community health,['10.1136/fmch-2020-000327']
3461,33060258,Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.,"BACKGROUND


Exogenous surfactants to treat respiratory distress syndrome (RDS) are approved for tracheal instillation only; this requires intubation, often followed by positive pressure ventilation to promote distribution. Aerosol delivery offers a safer alternative, but clinical studies have had mixed results. We hypothesized that efficient aerosolization of a surfactant with low viscosity, early in the course of RDS, could reduce the need for intubation and instillation of liquid surfactant.
METHODS


A prospective, multicenter, randomized, unblinded comparison trial of aerosolized calfactant (Infasurf) in newborns with signs of RDS that required noninvasive respiratory support. Calfactant was aerosolized by using a Solarys nebulizer modified with a pacifier adapter; 6 mL/kg (210 mg phospholipid/kg body weight) were delivered directly into the mouth. Infants in the aerosol group received up to 3 treatments, at least 4 hours apart. Infants in the control group received usual care, determined by providers. Infants were intubated and given instilled surfactant for persistent or worsening respiratory distress, at their providers' discretion.
RESULTS


Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams. In total, 230 infants were randomly assigned to aerosol; 225 received 334 treatments, starting at a median of 5 hours. The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P  < .0001). Respiratory outcomes up to 28 days of age were no different.
CONCLUSIONS


In newborns with early, mild to moderate respiratory distress, aerosolized calfactant at a dose of 210 mg phospholipid/kg body weight reduced intubation and surfactant instillation by nearly one-half.",2020,The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P  < .0001).,"['Newborns With Respiratory Distress', '230 infants', 'Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams', 'newborns with signs of RDS that required noninvasive respiratory support']","['Aerosolized Calfactant', 'aerosolized calfactant (Infasurf', 'instilled surfactant']",['rates of intubation for surfactant instillation'],"[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C5191367', 'cui_str': '595'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0763530', 'cui_str': 'calfactant'}, {'cui': 'C0763529', 'cui_str': 'Infasurf'}, {'cui': 'C1720298', 'cui_str': 'Instill'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}]",230.0,0.161211,The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group ( P  < .0001).,"[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Cummings', 'Affiliation': 'Albany Medical Center, Albany, New York; cummings.AMBI@gmail.com.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Gerday', 'Affiliation': 'Utah Valley Regional Medical Center, Provo, Utah.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Minton', 'Affiliation': 'Utah Valley Regional Medical Center, Provo, Utah.'}, {'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Katheria', 'Affiliation': 'Sharp Mary Birch Hospital for Women and Newborns, San Diego, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Albert', 'Affiliation': 'Sisters of Charity Hospital, Buffalo, New York.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Flores-Torres', 'Affiliation': 'Tampa General Hospital, Tampa, Florida.'}, {'ForeName': 'Mobolaji', 'Initials': 'M', 'LastName': 'Famuyide', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Oxford, Mississippi.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Children's Minnesota St. Paul Hospital, St. Paul, Minnesota.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Jackson-Madison County General Hospital, Jackson, Tennessee.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Kuehn', 'Affiliation': 'East Carolina University and Vidant Medical Center, Greenville, North Carolina.'}, {'ForeName': 'Jörn-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Fort', 'Affiliation': ""Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Elie G', 'Initials': 'EG', 'LastName': 'Abu Jawdeh', 'Affiliation': ""University of Kentucky Children's Hospital, Lexington, Kentucky.""}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Ryan', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Martin', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, Arizona.""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swanson', 'Affiliation': ""University of Virginia Children's Hospital, Charlottesville, Virginia.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Mulrooney', 'Affiliation': ""Children's Minneapolis Hospital, Minneapolis, Minnesota.""}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Eyal', 'Affiliation': ""University of South Alabama Children's and Women's Hospital, Mobile, Alabama.""}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Gerstmann', 'Affiliation': 'Timpanogos Regional Hospital, Orem, Utah.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': ""Order of St. Francis Children's Hospital of Illinois, Peoria, Illinois.""}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Wilding', 'Affiliation': 'Department of Biostatistics, University at Buffalo, Buffalo, New York; and.'}, {'ForeName': 'Edmund A', 'Initials': 'EA', 'LastName': 'Egan', 'Affiliation': 'ONY Biotech, Amherst, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2019-3967']
3462,33060370,Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.,"BACKGROUND


Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS


This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS


A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION


Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.",2020,"There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
","['A sub-population of study participants (≥18 years) of Chinese ethnicity', '441 Chinese patients', 'Chinese patients with moderate to severe plaque psoriasis']","['Secukinumab', 'placebo', 'secukinumab', 'subcutaneous injections of 300 or 150 mg secukinumab, or placebo']","['efficacy and safety', 'psoriasis area severity index (PASI', 'overall adverse events', 'Treatment efficacy']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",441.0,0.59253,"There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': ""Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'Jian-Zhong', 'Initials': 'JZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, Peking University People's Hospital, Beijing 100044, China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Institute of Dermatology, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Department of Dermatology, Changhai Hospital, Shanghai 200433, China.'}, {'ForeName': 'Quan-Zhong', 'Initials': 'QZ', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Tianjin Medical University General Hospital, Tianjin 300052, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Department of Dermatology, Second Affiliated Hospital School of Medicine, Zhejiang University, Hangzhou, Zhejiang 311215, China.'}, {'ForeName': 'Shi-Fa', 'Initials': 'SF', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, General Hospital of Northern Theater Command, Shenyang, Liaoning 110016, China.'}, {'ForeName': 'Jin-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Cheng-Xin', 'Initials': 'CX', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology and Venereology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Dermatology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong 510120, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Pan', 'Affiliation': ""Department of Dermatology, Zhejiang Provincial People's Hospital, Zhejiang, Hangzhou, Zhejiang 310014, China.""}, {'ForeName': 'Shen-Qiu', 'Initials': 'SQ', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Ruo-Yu', 'Initials': 'RY', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'Zai-Pei', 'Initials': 'ZP', 'LastName': 'Guo', 'Affiliation': 'Department of Dermatology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.'}, {'ForeName': 'Zhi-Qi', 'Initials': 'ZQ', 'LastName': 'Song', 'Affiliation': 'Department of Dermatology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, The First Hospital of Jilin University, Changchun, Jilin 130021, China.'}, {'ForeName': 'Xiu-Qin', 'Initials': 'XQ', 'LastName': 'Dong', 'Affiliation': 'Department of Dermatology, Guangdong General Hospital, Guangzhou, Guangdong 510080, China.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Fu', 'Affiliation': 'Beijing Novartis Pharma Co. Ltd., Shanghai 201203, China.'}, {'ForeName': 'Pascaline', 'Initials': 'P', 'LastName': 'Regnault', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Charef', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Mazur', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}, {'ForeName': 'Manmath', 'Initials': 'M', 'LastName': 'Patekar', 'Affiliation': 'Novartis Pharma AG, Basel 6463, Switzerland.'}]",Chinese medical journal,['10.1097/CM9.0000000000001163']
3463,33058835,Exogenous testosterone decreases men's sensitivity to vocal cues of male dominance.,"Assessing dominance is important for effective social interactions, and prior research suggests that testosterone is associated with men's dominance perceptions. The present study tested for a causal effect of exogenous testosterone on men's sensitivity to vocal cues of other men's dominance, an important parameter in male-male competition across species. One hundred and thirty-nine Chinese men received a single dose (150 mg) of testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Participants reported their own dominance and judged other men's dominance from voices. Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group. Moreover, men's dominance sensitivity was negatively associated with their self-reported dominance in our Chinese sample, consistent with findings from Western populations. These results indicate that exogenous testosterone has a causal effect in decreasing men's dominance sensitivity, consistent with the Challenge Hypothesis, suggesting that the fluctuation of testosterone concentration mediates individuals' behaviors. Additionally, the present study could motivate further work on vocal assessment in the context of competition in humans and other species.",2020,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"['One hundred and thirty-nine Chinese men', ""men's sensitivity to vocal cues of other men's dominance""]","['testosterone or placebo gel', 'Exogenous testosterone', 'testosterone', 'exogenous testosterone', 'placebo']","[""Men's dominance sensitivity""]","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",139.0,0.161778,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"[{'ForeName': 'Chengyang', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Watkins', 'Affiliation': 'Division of Psychology, School of Applied Sciences, Abertay University, Dundee, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nan', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Business Administration, Zhejiang University of Finance and Economics, Hangzhou, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104871']
3464,33065070,SGLT2 inhibitors and thiazide enhance excretion of DEHP toxic metabolites in subjects with type 2 diabetes: A randomized clinical trial.,"OBJECTIVE


Phthalates are non-persistent pollutants related to impaired metabolism and high cardiovascular risk. Their toxic metabolites are eliminated through urine and feces. Prevention policies are considered by the governments, although no therapeutic strategy to facilitate their elimination from the human body has been proposed so far. Aim of the present study was to verify, for the first time in humans, whether diuretics might be able to enhance phthalates' toxic metabolites urinary output.
DESIGN AND METHODS


We conducted a two-armed, parallel-design, randomized clinical trial. Thirty patients with type 2 diabetes and hypertension received a four week-treatment with Dapagliflozin 10 mg or Hydrochlorothiazide 12.5 mg. 24-hours urine were collected to measure urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP).
RESULTS


24-h urinary excretion of DEHP and MEHP was increased (+44%, p = 0.036; +49%, p = 0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p = 0.016; +36%, p = 0.062). Irrespective of the specific treatment, induced variations of daily urinary eliminations of MEHP metabolites were related with the 24-h urinary sodium (r = 0.42, p = 0.0226) and potassium (r = 0.54, p = 0.0026) excretion. Also, DEHP and MEOHP were related to sodium (r = 0·43, p = 0.0205; r = 0·44, p = 0.0168 respectively) but not to potassium.
CONCLUSIONS


Urinary phthalates excretion seems to occur mainly through sodium- and potassium-related mechanisms, apparently independent from the different diuretic effect. Both thiazide diuretics and SLGT2 inhibitors are effective into the removal of phthalates metabolites from the human body, reducing the human tissues' exposure to their toxicity.",2020,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","['Thirty patients with type 2 diabetes and hypertension', 'subjects with type 2 diabetes']","['SGLT2 inhibitors and thiazide', 'Dapaglifozin 10 mg or Hydrochlorothiazide', 'thiazide diuretics and SLGT2 inhibitors']","['DEHP toxic metabolites', '24-hours urinary excretion of DEHP and MEHP', 'DEHP and MEOHP', 'urinary excretion of three major 2-ethylhexyl-phthalate (DEHP) metabolites, i.e. mono 2-ethylhexyl phthalate (MEHP), mono-2-ethyl-5-oxohexyl phthalate (MEOHP) and mono 2-ethyl-5-hydroxyhexyl phthalate (MEHHP', '24-hour urinary sodium', 'daily urinary eliminations of MEHP metabolites']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0012197', 'cui_str': 'Di-2-ethylhexyl phthalate'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0220894', 'cui_str': 'Phthalic acid ester'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320408', 'cui_str': 'Urinary elimination status'}]",30.0,0.0815342,"RESULTS


24-hours urinary excretion of DEHP and MEHP was increased (+44%, p=0.036; +49%, p=0.0016) while MEOHP e MEHHP showed only a positive trend (+25%, p=0.016; +36%, p=0.062).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mengozzi', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Guiducci', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Parolini', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Biancalana', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Institute of Clinical Physiology, National Research Council, Pisa, Italy. Electronic address: amalia@ifc.cnr.it.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Solini', 'Affiliation': 'Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy. Electronic address: anna.solini@med.unipi.it.'}]",Environmental research,['10.1016/j.envres.2020.110316']
3465,33065218,The occlusal wear of ceramic fixed dental prostheses: 3-Year results in a randomized controlled clinical trial with split-mouth design.,"OBJECTIVES


This study's hypothesis was to evaluate differences of the occlusal wear rate for monolithically fabricated lithium disilicate and hand-veneered zirconia crowns in-vivo. Furthermore, a comparison of the materials' clinical performance according to CDA criteria was investigated.
METHODS


A total number of 15 patients in the need of full-coverage ceramic fixed dental prosthesis on molars were treated with two crowns each (n = 30), randomly assigned on the contralateral sides made of monolithic IPS e.max CAD (n = 15) and IPS e.max Ceram hand-veneered zirconia (n = 15). Clinical examination was conducted, silicone impressions were taken and plaster models fabricated at the day of crown insertion (baseline) and after 1, 2 and 3 years. The abrasion rate was digitally investigated: after model digitization with the industrial scanner Atos II, each follow-up model was superimposed with the baseline model. The wear was evaluated as the difference between two scans in terms of maximum vertical loss [mm], average decrease [mm] and volume loss [mm³]. For statistical analysis, the Mann-Whitney U test was performed and significance was set to less than 0.05.
RESULTS


IPS e.max CAD crowns showed a volume loss of -0.68 mm³ after three years, while IPS e.max Ceram hand-veneered zirconia crowns showed a volumetric wear of -0.75 mm³ at the same point of time. However, no significant differences were found between both materials regarding the 3 evaluated wear parameters. The survival rate for both materials was 100 % and the clinical performance outcome was good to excellent.
CONCLUSION


The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
CLINICAL SIGNIFICANCE


Ceramic restorations are subject to occlusal wear over time due to the natural masticatory process. Both monolithic lithium disilicate and glass-ceramic veneered zirconia copings showed clinically satisfactory results over 3 years in-situ. In terms of abrasion, they are equally well suited for clinical use.",2020,"The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
",['15 patients in the need of full-coverage ceramic fixed dental prosthesis on molars were treated with two crowns each (n\u2009=\u200930'],"['monolithic lithium disilicate and glass-ceramic veneered zirconia copings', 'monolithic IPS e.max CAD (n\u2009=\u200915) and IPS e.max Ceram hand-veneered zirconia']","['wear rates and clinical performance', 'volume loss', 'survival rate', 'abrasion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C4508100', 'cui_str': 'IPS e.max Ceram'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}]",,0.0308029,"The two investigated materials for ceramic fixed dental prostheses showed similar wear rates and clinical performance over an in-vivo use of 3 years.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Seidel', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany. Electronic address: anna.seidel@uk-erlangen.de.'}, {'ForeName': 'Renan', 'Initials': 'R', 'LastName': 'Belli', 'Affiliation': 'Laboratory of Dental Biomaterials, Department of Restorative Dentistry, University Hospital Erlangen of Friedrich-Alexander University Erlangen Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Breidebach', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wichmann', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Ragai Edward', 'Initials': 'RE', 'LastName': 'Matta', 'Affiliation': 'Department of Prosthodontics, University Hospital Erlangen of Friedrich-Alexander University Erlangen-Nürnberg (FAU), Glueckstrasse 11, 91054, Erlangen, Germany.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103500']
3466,33065228,Short and long-term effects of water-based aerobic and concurrent training on cardiorespiratory capacity and strength of older women.,"Studies show that, in the short term, water-based aerobic training (WAT) promotes the same strength gains as water-based concurrent training (WCT). In addition, it is known that some training progression strategy must be employed after the first weeks of training in order to continue stimulating neuromuscular gains. The aim of this paper was to compare the effects of three water-based training on cardiorespiratory capacity and strength of older women in short and long-terms. Fifty-seven participants were randomized into the groups: 1) aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS). Participants trained twice a week for 16 weeks. An incremental treadmill test and the one-repetition maximal test of knee extensors were performed before and after 8 and 16 weeks. Peak oxygen consumption showed similar increases from pre to post-16 weeks (AT: 9%, CTRE: 11%, CTMS: 5%). Oxygen consumption at the second ventilatory threshold and strength were increased from pre to post-8 weeks (AT: 15%, CTRE: 16%, CTMS: 3% and AT: 9%, CTRE: 5%, CTMS: 9%, respectively) and from post-8 to post-16 weeks (AT: 6%, CTRE: 3%, CTMS: 12% and AT: 4%, CTRE: 8%, CTMS: 4%, respectively). In conclusion, the three training programs promoted similar increases in the cardiorespiratory capacity and WAT promoted similar strength gains as WCT in short and long terms. Moreover, the use of resistive equipment and the increase in the number of sets are effective progression strategies.",2020,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"['older women', 'Fifty-seven participants', 'older women in short and long-terms']","['aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS', 'CTMS', 'three water-based training', 'water-based aerobic and concurrent training', 'water-based aerobic training (WAT']","['cardiorespiratory capacity and strength', 'Peak oxygen consumption', 'Oxygen consumption', 'strength gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0661732', 'cui_str': 'cyclohexane-1,2,4-tris(methylenesulfonate)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",57.0,0.0184618,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"[{'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: thais_reichert@hotmail.com.'}, {'ForeName': 'Rochelle Rocha', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Artur Avelino Birk', 'Initials': 'AAB', 'LastName': 'Preissler', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Henrique Bianchi', 'Initials': 'HB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cláudia Gomes', 'Initials': 'CG', 'LastName': 'Bracht', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Machado', 'Initials': 'BM', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Mello Bones da Rocha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andressa Freitas', 'Initials': 'AF', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Fernando Martins', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111103']
3467,33031652,Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.,"BACKGROUND


Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.
METHODS


In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.
RESULTS


The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.
CONCLUSIONS


Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.).",2020,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","['patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive', 'coronavirus disease 2019 ', 'Hospitalized Patients with Covid-19', 'patients hospitalized with Covid-19']","['hydroxychloroquine', 'hydroxychloroquine and 3155 to receive usual care', 'Hydroxychloroquine and chloroquine', 'Hydroxychloroquine', 'usual care']","['cardiac deaths', 'death', '28-day mortality', 'frequency of invasive mechanical ventilation or death', 'Death', 'incidence of new major cardiac arrhythmia', 'hospital alive']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",1561.0,0.344094,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiselka', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jakki', 'Initials': 'J', 'LastName': 'Faccenda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022926']
3468,33031713,Magnetic Resonance Imaging-Guided Fibrosis Ablation for the Treatment of Atrial Fibrillation: The ALICIA Trial.,"BACKGROUND


Myocardial fibrosis is key for atrial fibrillation maintenance. We aimed to test the efficacy of ablating cardiac magnetic resonance (CMR)-detected atrial fibrosis plus pulmonary vein isolation (PVI).
METHODS


This was an open-label, parallel-group, randomized, controlled trial. Patients with symptomatic drug-refractory atrial fibrillation (paroxysmal and persistent) undergoing first or repeat ablation were randomized in a 1:1 basis to receive PVI plus CMR-guided fibrosis ablation (CMR group) or PVI alone (PVI-alone group). The primary end point was the rate of recurrence (>30 seconds) at 12 months of follow-up using a 12-lead ECG and Holter monitoring at 3, 6, and 12 months. The analysis was conducted by intention-to-treat.
RESULTS


In total, 155 patients (71% male, age 59±10, CHA 2 DS 2 -VASc 1.3±1.1, 54% paroxysmal atrial fibrillation) were allocated to the PVI-alone group (N=76) or CMR group (N=79). First ablation was performed in 80% and 71% of patients in the PVI-alone and CMR groups, respectively. The mean atrial fibrosis burden was 12% (only ≈50% of patients had fibrosis outside the pulmonary vein area). One hundred percent and 99% of patients received the assigned intervention in the PVI-alone and CMR group, respectively. The primary outcome was achieved in 21 patients (27.6%) in the PVI-alone group and 22 patients (27.8%) in the CMR group (odds ratio: 1.01 [95% CI, 0.50-2.04];  P =0.976). There were no differences in the rate of adverse events (3 in the CMR group and 2 in the PVI-alone group;  P =0.68).
CONCLUSIONS


A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing atrial fibrillation ablation with low fibrosis burden. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02698631.",2020,- A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing AF ablation with low fibrosis burden.,"['unselected population undergoing AF ablation with low fibrosis burden', '155 patients (71% male, age 59±10, CHA2DS2-VASc 1.3±1.1, 54% Paroxysmal AF', 'Atrial Fibrillation', 'Patients with symptomatic drug-refractory AF (paroxysmal and persistent) undergoing first or repeat ablation']","['PVI plus CMR-guided fibrosis ablation (CMR group) or PVI alone (PVI-alone group', 'Magnetic Resonance Imaging-Guided Fibrosis Ablation', 'ablating cardiac magnetic resonance (CMR)-detected atrial fibrosis plus pulmonary vein isolation (PVI', 'CMR', 'PVI-alone and CMR']","['mean atrial fibrosis burden', 'rate of recurrence', 'rate of adverse events']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205311', 'cui_str': 'Paroxysmal'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",155.0,0.186259,- A pragmatic ablation approach targeting CMR-detected atrial fibrosis plus PVI was not more effective than PVI alone in an unselected population undergoing AF ablation with low fibrosis burden.,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Bisbal', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Benito', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Teis', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alarcón', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Sarrias', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Gala', 'Initials': 'G', 'LastName': 'Caixal', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Villuendas', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Paz', 'Initials': 'P', 'LastName': 'Garre', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Soto', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cozzari', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Guasch', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Juncà', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Prat-Gonzalez', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Rosario J', 'Initials': 'RJ', 'LastName': 'Perea', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Bazán', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Tolosana', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Arbelo', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic, University of Barcelona, Spain (E.B., F.A., G.C., P.G., J.C., E.G., S.P.-G., R.J.P., J.M.T., E.A., L.M.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'Heart Institute (iCor), University Hospital Germans Trias i Pujol, Badalona, Catalonia (F.B., A.T., A.S., R.V., N.S., G.J., V.B., A.B.-G.).'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'CIBERCV, Instituto de Salud Carlos III, Madrid (F.B., A.B.-G., L.M.).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008707']
3469,33031736,"2-year remission of type 2 diabetes and pancreas morphology: a post-hoc analysis of the DiRECT open-label, cluster-randomised trial.","BACKGROUND


The pancreas is small and irregular in shape in people with type 2 diabetes. If these abnormalities are caused by the disease state itself rather than being a predisposing factor, remission of type 2 diabetes should restore normal pancreas morphology. The objective of this study was to determine whether changes in pancreas volume and shape occurred during 2 years of remission.
METHODS


For this post-hoc analysis, we included a subset of adult participants of the Diabetes Remission Clinical Trial (DiRECT), who had type 2 diabetes and were randomly assigned to a weight management intervention or routine diabetes management. Intervention group participants were categorised as responders (HbA 1c  <6·5% [48 mmol/mol] and fasting blood glucose <7·0 mmol/L, off all anti-diabetes medication) and non-responders, who were classified as remaining diabetic. Data on pancreas volume and irregularity of pancreas border at baseline, 5 months, 12 months, and 24 months after intervention were compared between responders and non-responders; additional comparisons were made between control group participants with type 2 diabetes and a non-diabetic comparator (NDC) group, who were matched to the intervention group by age, sex, and post-weight-loss weight, to determine the extent of any normalisation. We used a mixed-effects regression model based on repeated measures ANOVA with correction for potential confounding. Magnetic resonance techniques were employed to quantify pancreas volume, the irregularity of the pancreas borders, and intrapancreatic fat content. β-cell function and biomarkers of tissue growth were also measured.
FINDINGS


Between July 25, 2015, and Aug 5, 2016, 90 participants with type 2 diabetes in the DiRECT subset were randomly assigned to intervention (n=64) or control (n=26) and were assessed at baseline; a further 25 non-diabetic participants were enrolled into the NDC group. At baseline, mean pancreas volume was 61·7 cm 3  (SD 16·0) in all participants with type 2 diabetes and 79·8 cm 3  (14·3) in the NDC group (p<0·0001). At 24 months, pancreas volume had increased by 9·4 cm 3  (95% CI 6·1 to 12·8) in responders compared with 6·4 cm 3  (2·5 to 10·3) in non-responders (p=0·0008). Pancreas borders at baseline were more irregular in participants with type 2 diabetes than in the NDC group (fractal dimension 1·138 [SD 0·027] vs 1·097 [0·025]; p<0·0001) and had normalised by 24 months in responders only (1·099 [0·028]). Intrapancreatic fat declined by 1·02 percentage points (95% CI 0·53 to 1·51) in 32 responders and 0·51% (-0·17 to 1·19) in 13 non-responders (p=0·23).
INTERPRETATION


These data show for the first time, to our knowledge, reversibility of the abnormal pancreas morphology of type 2 diabetes by weight loss-induced remission.
FUNDING


Diabetes UK.",2020,"Intrapancreatic fat declined by 1·02 percentage points (95% CI 0·53 to 1·51) in 32 responders and 0·51% (-0·17 to 1·19) in 13 non-responders (p=0·23).
","['people with type 2 diabetes', 'Between July 25, 2015, and Aug 5, 2016, 90 participants with type', 'participants with type 2 diabetes than in the NDC group (fractal dimension', 'adult participants of the Diabetes Remission Clinical Trial (DiRECT), who had type 2 diabetes', '2 diabetes in the DiRECT subset were randomly assigned to intervention (n=64) or control (n=26) and were assessed at baseline; a further 25 non-diabetic participants were enrolled into the NDC group']",['weight management intervention or routine diabetes management'],"['pancreas volume and shape', 'mean pancreas volume', 'Intrapancreatic fat', '2-year remission', 'pancreas volume', 'β-cell function and biomarkers of tissue growth', 'pancreas volume and irregularity of pancreas border']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}]",90.0,0.0452818,"Intrapancreatic fat declined by 1·02 percentage points (95% CI 0·53 to 1·51) in 32 responders and 0·51% (-0·17 to 1·19) in 13 non-responders (p=0·23).
","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Al-Mrabeh', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. Electronic address: ahmad.al-mrabeh2@ncl.ac.uk.'}, {'ForeName': 'Kieren G', 'Initials': 'KG', 'LastName': 'Hollingsworth', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'James A M', 'Initials': 'JAM', 'LastName': 'Shaw', 'Affiliation': 'Regenerative Medicine, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Magnetic Resonance Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30303-X']
3470,33053090,Diagnostic precision for bronchopulmonary aspiration in a heterogeneous population.,"PURPOSE


The purpose of the present study was to assess the validity of a simple instrument for screening dysphagia used in a large public hospital in Brazil with heterogeneous adult population.
METHOD


The Dysphagia Risk Evaluation Protocol (DREP) - screening version contains four items (altered cervical auscultation, altered vocal quality, coughing and choking before / during / after swallowing) that were previously indicated as independent risk factors associated to the presence of dysphagia in the swallowing test with water. Trained speech therapists administered and scored DREP - screening version to consecutive patients referred by hospital's medical team to perform Video Fluoroscopic for Swallowing Study (VFSS).
RESULTS


211 patients received the swallowing screen (DREP): 99 failed and 112 passed. One in every five patients was randomized to receive a VFSS. The DREP screening version demonstrated excellent validity with sensitivity at 92.9%, specificity at 75.0%, negative predictive values at 95.5% and an accuracy of 80.9%.
CONCLUSION


The DREP - screening version is a simple and accurate tool to identify the risk for penetration and / or aspiration in patients who are not tube-fed, who have a good level of alertness, have no history of recurrent pneumonia, are not on pneumonia, and that do not use a tracheostomy cannula.",2020,"The DREP screening version demonstrated excellent validity with sensitivity at 92.9%, specificity at 75.0%, negative predictive values at 95.5% and an accuracy of 80.9%.
","[""consecutive patients referred by hospital's medical team to perform Video Fluoroscopic for Swallowing Study (VFSS"", 'screening dysphagia used in a large public hospital in Brazil with heterogeneous adult population', '211 patients received the swallowing screen (DREP): 99 failed and 112 passed']","['Trained speech therapists administered and scored DREP - screening version', 'VFSS']","['negative predictive values', 'Dysphagia Risk Evaluation Protocol (DREP) - screening version contains four items (altered cervical auscultation, altered vocal quality, coughing and choking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3888792', 'cui_str': 'Swallow study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0402015', 'cui_str': 'Speech and language therapist'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0008301', 'cui_str': 'Choking'}]",211.0,0.0328642,"The DREP screening version demonstrated excellent validity with sensitivity at 92.9%, specificity at 75.0%, negative predictive values at 95.5% and an accuracy of 80.9%.
","[{'ForeName': 'Maíra Santilli de', 'Initials': 'MS', 'LastName': 'Lima', 'Affiliation': 'Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Fernanda Chiarion', 'Initials': 'FC', 'LastName': 'Sassi', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Gisele Chagas de', 'Initials': 'GC', 'LastName': 'Medeiros', 'Affiliation': 'Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Shri Krishna', 'Initials': 'SK', 'LastName': 'Jayanthi', 'Affiliation': 'Instituto de Radiologia, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}, {'ForeName': 'Claudia Regina Furquim de', 'Initials': 'CRF', 'LastName': 'Andrade', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional, Faculdade de Medicina da Universidade de São Paulo - USP - São Paulo (SP), Brasil.'}]",CoDAS,['10.1590/2317-1782/20202019166']
3471,33058694,"Development of the English Listening and Reading Computerized Revised Token Test Into Cantonese: Validity, Reliability, and Sensitivity/Specificity in People With Aphasia and Healthy Controls.","Purpose This study reports the psychometric development of the Cantonese versions of the English Computerized Revised Token Test (CRTT) for persons with aphasia (PWAs) and healthy controls (HCs). Method The English CRTT was translated into standard Chinese for the Reading-Word Fade version (CRTT-R- WF -Cantonese) and into formal Cantonese for the Listening version (CRTT-L-Cantonese). Thirty-two adult native Cantonese PWAs and 42 HCs were tested on both versions of CRTT-Cantonese tests and on the Cantonese Aphasia Battery to measure the construct and concurrent validity of CRTT-Cantonese tests. The HCs were retested on both versions of the CRTT-Cantonese tests, whereas the PWAs were randomly assigned for retesting on either version to measure the test-retest reliability. Results A two-way, Group × Modality, repeated-measures analysis of variance revealed significantly lower scores for the PWA group than the HC group for both reading and listening. Other comparisons were not significant. A high and significant correlation was found between the CRTT-R- WF -Cantonese and the CRTT-L-Cantonese in PWAs, and 87% of the PWAs showed nonsignificantly different performance across the CRTT-Cantonese tests based on the Revised Standardized Difference Test. The CRTT-R- WF -Cantonese provided better aphasia diagnostic sensitivity (100%) and specificity (83.30%) values than the CRTT-L-Cantonese. Pearson correlation coefficients revealed significant moderate correlations between the Cantonese Aphasia Battery scores and the CRTT-Cantonese tests in PWAs, supporting adequate concurrent validity. Intraclass correlation coefficient showed high test-retest reliability (between .82 and .96,  p  < .001) for both CRTT-Cantonese tests for both groups. Conclusions Results support that the validly translated CRTT-R- WF -Cantonese and CRTT-L-Cantonese tests significantly differentiate the reading and listening comprehension of PWAs from HCs and provides acceptable concurrent validity and high test-retest reliability for both tests. Furthermore, favorable PWA versus HC sensitivity and specificity cutoff scores are presented for both CRTT-Cantonese listening and reading tests.",2020,The CRTT-R- WF -Cantonese provided better aphasia diagnostic sensitivity (100%) and specificity (83.30%) values than the CRTT-L-Cantonese.,"['persons with aphasia (PWAs) and healthy controls (HCs', 'People With Aphasia and Healthy Controls', 'Thirty-two adult native Cantonese PWAs and 42 HCs']",['English Computerized Revised Token Test (CRTT'],"['aphasia diagnostic sensitivity', 'favorable PWA versus HC sensitivity and specificity cutoff scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0582662', 'cui_str': 'Revised token test'}]","[{'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",32.0,0.0194605,The CRTT-R- WF -Cantonese provided better aphasia diagnostic sensitivity (100%) and specificity (83.30%) values than the CRTT-L-Cantonese.,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Bakhtiar', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Min Ney', 'Initials': 'MN', 'LastName': 'Wong', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Emily Ka Yin', 'Initials': 'EKY', 'LastName': 'Tsui', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'McNeil', 'Affiliation': 'Department of Communication Science and Disorders, University of Pittsburgh, PA.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00103']
3472,33065035,"Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (≥65 years): two multicentre, randomised phase 3 trials.","BACKGROUND


Seasonal influenza remains a substantial public health threat despite the availability of egg-derived and other vaccines. Plant-based manufacturing might address some of the limitations of current vaccines. We describe two phase 3 efficacy studies of a recombinant quadrivalent virus-like particle (QVLP) influenza vaccine manufactured in plants, one in adults aged 18-64 years (the 18-64 study) and one in older people aged 65 years and older (the 65-plus study).
METHODS


We did two randomised, observer-blind, multinational studies in the northern hemisphere in the 2017-18 (the 18-64 study) and 2018-19 (the 65-plus study) influenza seasons. The 18-64 study was done at 73 sites and the 65-plus study was done at 104 sites, both across Asia, Europe, and North America. In the 18-64 study, inclusion criteria were body-mass index less than 40 kg/m 2 ; age 18-64 years at screening visit; and good health. In the 65-plus study, inclusion criteria were body-mass index of maximum 35 kg/m 2 ; aged 65 years or older at screening visit; not living in a rehabilitation centre or care home; and no acute or evolving medical problems. Participants in the 18-64 study were randomly assigned (1:1) to receive either QVLP vaccine (30 μg haemagglutinin per strain) or placebo. Participants in the 65-plus study were randomly assigned (1:1) to receive QVLP vaccine (30 μg haemagglutinin per strain) or quadrivalent inactivated vaccine (QIV; 15 μg haemagglutinin per strain). The primary outcome in the 18-64 study was absolute vaccine efficacy to prevent laboratory-confirmed, respiratory illness caused by antigenically matched influenza strains. The primary outcome in the 65-plus study was relative vaccine efficacy to prevent laboratory-confirmed influenza-like illness caused by any influenza strain. The primary analyses were done in the per-protocol population and safety was assessed in all participants who received the assigned treatment. These studies are registered with ClinicalTrials.gov (18-64 study NCT03301051; 65-plus study NCT03739112).
FINDINGS


In the 18-64 study, between Aug 30, 2017, and Jan 15, 2018, 10 160 participants were randomly assigned to receive either QVLP vaccine (5077 participants) or placebo (5083 participants). The per-protocol population consisted of 4814 participants in the QVLP group and 4812 in the placebo group. The study did not meet its primary endpoint of 70% absolute vaccine efficacy for the QVLP vaccine (35·1% [95% CI 17·9 to 48·7]) against respiratory illness caused by matched strains. 55 (1·1%) of 5064 participants in the QVLP group versus 51 (1·0%) of 5072 in the placebo group had a serious adverse event. Four (0·1%) and six [0·1%] participants had severe treatment-related treatment-emergent adverse events. In the 65-plus study, between Sept 18, 2018, and Feb 22, 2019, 12 794 participants were randomly assigned to receive either QVLP vaccine (6396 participants) or QIV (6398 participants). The per-protocol population consisted of 5996 participants in the QVLP group and 6026 in the QIV group. The study met its primary non-inferiority endpoint with a relative vaccine efficacy of the QVLP vaccine for the prevention of influenza-like illness caused by any strain of 8·8% (-16·7 to 28·7). 263 (4·1%) of 6352 participants in the QVLP group versus 266 (4·2%) of 6366 in the QIV group had serious adverse events (one [<0·1%] vs two [<0·1%] were considered treatment-related); one (<0·1%) versus three (<0·1%) participants had severe treatment-related treatment-emergent adverse events.
INTERPRETATION


These efficacy studies are the first large-scale studies of any plant-derived human vaccine. Together, they show that the plant-derived QVLP vaccine can provide substantial protection against respiratory illness and influenza-like illness caused by influenza viruses in adults. QVLP vaccine was well tolerated and no major safety signal arose in participants who received QVLP vaccine across the two studies.
FUNDING


Medicago.",2020,"QVLP vaccine was well tolerated and no major safety signal arose in participants who received QVLP vaccine across the two studies.
","['In the 65-plus study, between Sept 18, 2018, and Feb 22, 2019, 12\u2008794 participants', 'adults (18-64 years) and older adults (≥65 years', 'The 18-64 study was done at 73 sites and the 65-plus study was done at 104 sites, both across Asia, Europe, and North America', '6396 participants) or QIV (6398 participants', 'Participants in the 65-plus study', 'northern hemisphere in the 2017-18 (the 18-64 study) and 2018-19 (the 65-plus study) influenza seasons', 'In the 18-64 study, between Aug 30, 2017, and Jan 15, 2018, 10\u2008160 participants', '4814 participants in the QVLP group and 4812 in the placebo group', 'adults aged 18-64 years (the 18-64 study) and one in older people aged 65 years and older (the 65-plus study', 'In the 65-plus study, inclusion criteria were body-mass index of maximum 35 kg/m 2 ; aged 65 years or older at screening visit; not living in a rehabilitation centre or care home; and no acute or evolving medical problems', 'for the prevention of influenza-like illness caused by any strain of 8·8% (-16·7 to 28·7', '5996 participants in the QVLP group and 6026 in the QIV group', 'In the 18-64 study, inclusion criteria were body-mass index less than 40 kg/m 2 ; age 18-64 years at screening visit; and good health', 'Participants in the 18-64 study']","['QVLP vaccine (30 μg haemagglutinin per strain) or quadrivalent inactivated vaccine (QIV; 15 μg haemagglutinin per strain', 'plant-derived, quadrivalent, virus-like particle influenza vaccine', 'plant-derived QVLP vaccine', 'QVLP', 'placebo', 'recombinant quadrivalent virus-like particle (QVLP) influenza vaccine manufactured', 'QVLP vaccine']","['vaccine efficacy', 'Efficacy, immunogenicity, and safety', 'tolerated and no major safety signal', 'relative vaccine efficacy to prevent laboratory-confirmed influenza-like illness caused by any influenza strain', 'serious adverse event', 'absolute vaccine efficacy to prevent laboratory-confirmed, respiratory illness', 'respiratory illness', 'serious adverse events', 'severe treatment-related treatment-emergent adverse events']","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2936379', 'cui_str': 'Virus-Like Particle Vaccines'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",12794.0,0.380196,"QVLP vaccine was well tolerated and no major safety signal arose in participants who received QVLP vaccine across the two studies.
","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ward', 'Affiliation': 'Medicago, Quebec, QC, Canada; Research Institute of the McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Makarkov', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Séguin', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Pillet', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Trépanier', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Jiwanjeet', 'Initials': 'J', 'LastName': 'Dhaliwall', 'Affiliation': 'Medicago, Quebec, QC, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Libman', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Nordic Research Network Oy, Tampere, Finland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Landry', 'Affiliation': 'Medicago, Quebec, QC, Canada. Electronic address: landryn@medicago.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)32014-6']
3473,33065448,"Effectiveness of a home-based early cognitive-motor intervention provided in daycare, home care, and foster care settings: Changes in motor development and context affordances.","BACKGROUND


Appropriate opportunities within the context are crucial to affect the motor trajectory positively.
OBJECTIVE


To investigate the effectiveness of professional-parental/caregivers' early motor-cognitive intervention on infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC). Secondary objectives were to examine if parents and caregivers modified the context to meet the infants' needs and if making modifications was positively associated with infants' development.
METHODS


Participants were 176 infants (DC = 48; HC = 58, FC = 70). Infants' were randomly assigned to intervention (IG) or comparison (CG) groups within each context. The Alberta Infant Motor Scale and Affordances in the Daycare and Home Environment for Motor Development were used. A cognitive-motor intervention was provided for infants in the intervention groups; and, a home-based support protocol for all caregivers and parents.
RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028). Maternal daily care and home opportunities improved for all infants.
CONCLUSIONS


Parents/caregivers' protocol combined with the cognitive-motor intervention lead to better motor outcomes and changes in the context for the IGs. Only the parent/caregivers' protocol was not strong to improve CGs motor outcomes, although changes in context were found. Intensive intervention is need for infants living in vulnerability.",2020,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","['Infants', 'infants living in vulnerability', 'Participants were 176 infants (DC\xa0=\xa048; HC\xa0=\xa058, FC\xa0=\xa070']","['cognitive-motor intervention', 'intervention (IG) or comparison (CG', ""professional-parental/caregivers' early motor-cognitive intervention"", 'home-based early cognitive-motor intervention', 'Intensive intervention']","['Maternal daily care and home opportunities', ""infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC"", 'CGs motor outcomes', 'motor scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",176.0,0.0591172,"RESULTS


IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: nadiacv@esef.ufrgs.br.'}, {'ForeName': 'Carla Skilhan', 'Initials': 'CS', 'LastName': 'de Almeida', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'University of Southern California, Division of Biokinesiology and Physical Therapy, Los Angeles, CA, USA.'}]",Early human development,['10.1016/j.earlhumdev.2020.105223']
3474,33026741,Interferon Beta-1b and Lopinavir-Ritonavir for Middle East Respiratory Syndrome.,"BACKGROUND


Whether combined treatment with recombinant interferon beta-1b and lopinavir-ritonavir reduces mortality among patients hospitalized with Middle East respiratory syndrome (MERS) is unclear.
METHODS


We conducted a randomized, adaptive, double-blind, placebo-controlled trial that enrolled patients at nine sites in Saudi Arabia. Hospitalized adults with laboratory-confirmed MERS were randomly assigned to receive recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo for 14 days. The primary outcome was 90-day all-cause mortality, with a one-sided P-value threshold of 0.025. Prespecified subgroup analyses and safety analyses were conducted. Because of the pandemic of coronavirus disease 2019, the data and safety monitoring board requested an unplanned interim analysis and subsequently recommended the termination of enrollment and the reporting of the results.
RESULTS


A total of 95 patients were enrolled; 43 patients were assigned to the intervention group and 52 to the placebo group. A total of 12 patients (28%) in the intervention group and 23 (44%) in the placebo group died by day 90. The analysis of the primary outcome, with accounting for the adaptive design, yielded a risk difference of -19 percentage points (upper boundary of the 97.5% confidence interval [CI], -3; one-sided P = 0.024). In a prespecified subgroup analysis, treatment within 7 days after symptom onset led to lower 90-day mortality than use of placebo (relative risk, 0.19; 95% CI, 0.05 to 0.75), whereas later treatment did not. Serious adverse events occurred in 4 patients (9%) in the intervention group and in 10 (19%) in the placebo group.
CONCLUSIONS


A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS. The effect was greatest when treatment was started within 7 days after symptom onset. (Funded by the King Abdullah International Medical Research Center; MIRACLE ClinicalTrials.gov number, NCT02845843.).",2020,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"['A total of 95 patients were enrolled; 43 patients', 'Hospitalized adults with laboratory-confirmed MERS', 'enrolled patients at nine sites in Saudi Arabia', 'Middle East Respiratory Syndrome', 'patients hospitalized with Middle East respiratory syndrome (MERS', 'patients who had been hospitalized with laboratory-confirmed MERS']","['Interferon Beta-1b and Lopinavir-Ritonavir', 'placebo', 'recombinant interferon beta-1b and lopinavir-ritonavir', 'recombinant interferon beta-1b plus lopinavir-ritonavir (intervention) or placebo']","['90-day all-cause mortality', 'Serious adverse events', '90-day mortality']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}]","[{'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",95.0,0.768763,A combination of recombinant interferon beta-1b and lopinavir-ritonavir led to lower mortality than placebo among patients who had been hospitalized with laboratory-confirmed MERS.,"[{'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ayed Y', 'Initials': 'AY', 'LastName': 'Asiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Assiri', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanan H', 'Initials': 'HH', 'LastName': 'Balkhy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Bshabshe', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Al Jeraisy', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandourah', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed H A', 'Initials': 'MHA', 'LastName': 'Azzam', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulhadi M', 'Initials': 'AM', 'LastName': 'Bin Eshaq', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameera', 'Initials': 'S', 'LastName': 'Al Johani', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shmeylan', 'Initials': 'S', 'LastName': 'Al Harbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hani A A', 'Initials': 'HAA', 'LastName': 'Jokhdar', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Deeb', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Memish', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jesna', 'Initials': 'J', 'LastName': 'Jose', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sameeh', 'Initials': 'S', 'LastName': 'Ghazal', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Al Faraj', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ghaleb A', 'Initials': 'GA', 'LastName': 'Al Mekhlafi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nisreen M', 'Initials': 'NM', 'LastName': 'Sherbeeni', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fatehi E', 'Initials': 'FE', 'LastName': 'Elzein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Al Saedi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Naif K', 'Initials': 'NK', 'LastName': 'Alharbi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Al-Dawood', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelzaher', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wail', 'Initials': 'W', 'LastName': 'Bajhmom', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Badriah M', 'Initials': 'BM', 'LastName': 'AlMutairi', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Alothman', 'Affiliation': 'From the Intensive Care Department (Y.M.A., A.A.-D.) and the Departments of Infection Prevention and Control (H.H.B.), Pathology and Laboratory Medicine (S.A.J.), Pharmaceutical Care (S.A.H.), and Medicine (A.A.), King Abdulaziz Medical City, Ministry of National Guard Health Affairs, the College of Medicine (Y.M.A., S.A.J., A.A.-D., A.A.) and the College of Pharmacy (M.A.J., S.A.H.), King Saud bin Abdulaziz University for Health Sciences, Prince Mohammed bin Abdulaziz Hospital (A.Y.A., Z.A.M., S.G., S.A.F.), Infection Prevention and Control, Preventive Health (A.M.A.), and Deputyship for Public Health (H.A.A.J.), Ministry of Health, Clinical Trials Services (M.A.J., A.M.D., B.M.A.) and the Departments of Biostatistics and Informatics (J.J., M.A.H.) and Infectious Disease Research (N.K.A.), King Abdullah International Medical Research Center, the Military Medical Services, Ministry of Defense (Y.M.), the Department of Intensive Care Services (G.A.A.M.), and the Infectious Diseases Division (N.M.S., F.E.E.), Prince Sultan Military Medical City, and the College of Medicine, Alfaisal University (Z.A.M.), Riyadh, the Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha (A.A.B.), Medical Services (M.H.A.A.) and the Department of Critical Care Medicine (M.A.), King Abdullah Medical Complex, the Health Directorate, Ministry of Health (M.H.A.A.), and the Internal Medicine Department, King Fahad General Hospital, Ministry of Health (W.B.), the Intensive Care Department (F.A.-H.) and the Department of Infection Prevention and Control (A.A.S.), Ministry of National Guard Health Affairs, and the College of Medicine and King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center (F.A.-H., A.A.S.), Jeddah, and the Intensive Care Department, King Khalid Hospital, Najran (A.M.B.E.) - all in Saudi Arabia; the World Health Organization, Geneva (H.H.B.); the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta (Z.A.M.); the Departments of Critical Care Medicine and Medicine, Sunnybrook Hospital, and the Institute of Health Policy Management and Evaluation, University of Toronto, Toronto (R.A.F.); and the Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015294']
3475,33055139,"Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial.","OBJECTIVE


To investigate glycemic and psychosocial outcomes with hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump (i.e., standard therapy for most adults with type 1 diabetes).
RESEARCH DESIGN AND METHODS


Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26 weeks of HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked CGM time in range (TIR; 70-180 mg/dL) during the final 3 weeks.
RESULTS


Participants were randomized to HCL ( n  = 61) or control ( n  = 59). Baseline mean (SD) age was 44.2 (11.7) years, HbA 1c  was 7.4% (0.9%) (57 [10] mmol/mol), 53% were women, and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15% [95% CI 11, 19];  P  < 0.0001). For HCL, HbA 1c  was lower (median [95% CI] difference -0.4% [-0.6, -0.2]; -4 mmol/mol [-7, -2];  P  < 0.0001) and diabetes-specific positive well-being was higher (difference 1.2 [95% CI 0.4, 1.9];  P  < 0.0048) without a deterioration in diabetes distress, perceived sleep quality, or cognition. Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.
CONCLUSIONS


In adults with type 1 diabetes, 26 weeks of HCL improved TIR, HbA 1c , and their sense of satisfaction from managing their diabetes compared with those continuing with user-determined insulin dosing and self-monitoring of blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable, and advantageous.",2020,"Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.
","['Adults With Type 1 Diabetes', 'most adults with type 1 diabetes', 'Adults with type']","['MDI or insulin pump without continuous glucose monitoring (CGM', 'HCL', 'Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring', 'hybrid closed-loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump', 'HCL (Medtronic 670G) or continuation of current therapy']","['diabetes distress, perceived sleep quality, or cognition', 'masked CGM time', 'diabetes-specific positive well-being higher', 'HCL TIR', 'serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.184635,"Seventeen (9 device-related) versus 13 serious adverse events occurred in the HCL and control groups, respectively.
","[{'ForeName': 'Sybil A', 'Initials': 'SA', 'LastName': 'McAuley', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Paldus', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vogrin', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Abraham', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Leon A', 'Initials': 'LA', 'LastName': 'Bach', 'Affiliation': 'Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia.'}, {'ForeName': 'Morton G', 'Initials': 'MG', 'LastName': 'Burt', 'Affiliation': 'Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Neale D', 'Initials': 'ND', 'LastName': 'Cohen', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Colman', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Davis', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Hendrieckx', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'D Jane', 'Initials': 'DJ', 'LastName': 'Holmes-Walker', 'Affiliation': 'Department of Diabetes and Endocrinology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Joey', 'Initials': 'J', 'LastName': 'Kaye', 'Affiliation': 'Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Kumareswaran', 'Affiliation': 'Department of Endocrinology and Diabetes, The Alfred, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'McCallum', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Hobart Hospital, Hobart, Tasmania, Australia.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Psychology, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Stranks', 'Affiliation': 'Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Vijaya', 'Initials': 'V', 'LastName': 'Sundararajan', 'Affiliation': 'Department of Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Trawley', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Ward', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': ""Department of Endocrinology and Diabetes, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': ""O'Neal"", 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-1447']
3476,33054556,Augmenting Frontal Dopamine Tone Enhances Maintenance over Gating Processes in Working Memory.,"The contents of working memory must be maintained in the face of distraction, but updated when appropriate. To manage these competing demands of stability and flexibility, maintained representations in working memory are complemented by distinct gating mechanisms that selectively transmit information into and out of memory stores. The operations of such dopamine-dependent gating systems in the midbrain and striatum and their complementary dopamine-dependent memory maintenance operations in the cortex may therefore be dissociable. If true, selective increases in cortical dopamine tone should preferentially enhance maintenance over gating mechanisms. To test this hypothesis, tolcapone, a catechol- O -methyltransferase inhibitor that preferentially increases cortical dopamine tone, was administered in a randomized, double-blind, placebo-controlled, within-subject fashion to 49 participants who completed a hierarchical working memory task that varied maintenance and gating demands. Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution. Resting-state fMRI data demonstrated that the degree to which tolcapone improved performance in individual participants correlated with increased connectivity between a region important for first-order stimulus response mappings (left dorsal premotor cortex) and cortical areas implicated in visual working memory, including the intraparietal sulcus and fusiform gyrus. Together, these results provide evidence that augmenting cortical dopamine tone preferentially improves working memory maintenance.",2020,"Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution.",['49 participants who completed a hierarchical working memory task that varied maintenance and gating demands'],"['placebo', 'Tolcapone']",['working memory maintenance'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",49.0,0.073384,"Tolcapone improved performance in a condition with higher maintenance requirements and reduced gating demands, reflected in a reduction in the slope of RTs across the distribution.","[{'ForeName': 'Daniella J', 'Initials': 'DJ', 'LastName': 'Furman', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Chatham', 'Affiliation': 'F. Hoffman-La Roche AG, Basel Switzerland.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Good', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Badre', 'Affiliation': 'Brown University.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kayser', 'Affiliation': 'University of California, San Francisco.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01641']
3477,33059233,Transverse abdominis activity and ultrasound biofeedback in college golfers with and without low back pain.,"OBJECTIVES


To compare transverse abdominis (TrA) muscle activity in college golfers with and without a history of low back pain (LBP) and examine the effects of ultrasound biofeedback and a functional golf-setup position on TrA activity.
DESIGN


Crossover study.
SETTING


Laboratory.
PARTICIPANTS


Thirty-two (n = 32) collegiate golfers were stratified into either the LBP group (n = 16, 4.6 ± 4.5 LBP episodes) or non-LBP group (n = 16, 0.1 ± 0.3 LBP episodes) based on LBP episodes in the last 6-months.
MAIN OUTCOME MEASURES


Ultrasound measures of TrA activity were performed during standard contractions and contractions with ultrasound biofeedback. Contraction-type order was randomized between two visits. Testing was performed in two positions, supine and golf-setup positions.
RESULTS


We observed no significant differences in TrA activity between the LBP and non-LBP groups. Overall, TrA activity was greater during biofeedback contractions compared to standard contractions, and TrA activity was lower in the golf-setup position compared to the supine position.
CONCLUSIONS


We observed no differences in TrA activity between college golfers with and without LBP. College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.",2020,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"['college golfers with and without low back pain', 'Thirty-two (n\xa0=\xa032) collegiate golfers', 'college golfers with and without a history of low back pain (LBP']","['ultrasound biofeedback and a functional golf-setup position', 'LBP', 'LBP episodes) or non-LBP']","['Transverse abdominis activity and ultrasound biofeedback', 'standard contractions and contractions with ultrasound biofeedback', 'Overall, TrA activity', 'transverse abdominis (TrA) muscle activity', 'TrA activity']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018041', 'cui_str': 'Golfing'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",32.0,0.02025,College golfers with and without LBP demonstrated a greater ability to contract their TrA with real-time ultrasound biofeedback and a lower ability to contract their TrA in the functional golf-setup position compared to the traditional supine position.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Skibski', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: askibski19@adrian.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Burkholder', 'Affiliation': 'Department of Exercise Science & Athletic Training, Adrian College, Adrian, MI, USA. Electronic address: eburkholder@adrian.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Health Professions, James Madison University, Harrisonburg, VA, USA. Electronic address: goetscjw@jmu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.004']
3478,33059317,How to introduce a rotigotine patch to Parkinson's disease patients taking oral dopamine agonists.,"OBJECTIVE


Ways of introducing a rotigotine patch to Parkinson disease (PD) patients include initial induction for dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT), and add-on (AO) for patients already taking oral DAs. We investigated whether or not the introductions method affects the continuation rate of rotigotine patch.
METHODS


The subjects were 188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital. The rate of successful continuation of rotigotine patch for one year after initiation and the reasons for discontinuation were investigated; for the patients who discontinued due to poor efficacy, the DA dose before and after the start of rotigotine patch treatment was determined.
RESULTS


The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group. The most common reason for discontinuation in all groups was skin reactions. Compared with the de novo group, only the OS group had a significantly higher discontinuation rate due to poor efficacy (3.8 % vs. 21.2 %, P <  0.001). However, in the OS group, the continuation rate in the subjects with an increased total DA dose, after rotigotine was introduced, was significantly higher than that in the subjects with a decreased total DA dose (p = 0.031).
CONCLUSION


The use of a rotigotine patch with an equivalent dose should be considered when switching from oral DAs, and appropriate care should be administered for any skin reactions. The present findings suggested that not the introduction method but the use of an equivalent dose between DA formulations might affect the continuation rate of rotigotine patch.",2020,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","['patients already taking oral DAs', '188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital', ""Parkinson's disease patients taking oral dopamine agonists""]","['dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT', 'rotigotine patch']","['continuation rate of rotigotine patch', 'rate of successful continuation of rotigotine patch', 'continuation rate', 'discontinuation rate', '1-year continuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439234', 'cui_str': 'year'}]",188.0,0.0281234,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yasutaka', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Fujioka', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan. Electronic address: shinsuke@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Mishima', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hirotomo', 'Initials': 'H', 'LastName': 'Shibaguchi', 'Affiliation': 'Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Kamimura', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106266']
3479,33065163,Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections?,"BACKGROUND & AIMS


Angiotensin converting enzyme (ACE)-2 is a modulator of adipose tissue metabolism. However, human data of adipose ACE-2 is rarely available. Considering that, ACE-2 is believed to be the receptor responsible for cell entry of SARS-CoV-2, a better understanding of its regulation is desirable. We therefore characterized the modulation of subcutaneous adipose ACE-2 mRNA expression during weight loss and the impact of ACE-2 expression on weight loss induced short- and long-term improvements of glucose metabolism.
METHODS


143 subjects (age > 18; BMI ≥ 27 kg/m 2 ) were analyzed before and after a standardized 12-week dietary weight reduction program. Afterwards subjects were randomized to a 12-month lifestyle intervention or a control group (Maintain-Adults trial). Insulin sensitivity (IS) was estimated by HOMA-IR (as an estimate of liver IS) and ISI Clamp  (as an estimate of skeletal muscle IS). ACE-2 mRNA expression (ACE-2 AT ) was measured in subcutaneous adipose tissue before and after weight loss.
RESULTS


ACE-2 AT  was not affected by obesity, but was reduced in insulin resistant subjects. Weight loss resulted in a decline of ACE-2 AT  (29.0 (20.0-47.9) vs. 21.0 (13.0-31.0); p = 1.6 ∗ 10 -7 ). A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss. The degree of changes in insulin resistance were preserved until month 12 and was also predicted by the weight loss induced degree of ΔACE-2 AT  (p = 0.011).
CONCLUSIONS


Our data indicate that subcutaneous adipose ACE-2 expression correlates with insulin sensitivity. Weight loss induced decline of subcutaneous adipose ACE-2 expression might affect short- and long-term improvement of myocellular insulin sensitivity, which might be also relevant in the context of ACE-2 downregulation by SARS-CoV-2.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT00850629, https://clinicaltrials.gov/ct2/show/NCT00850629, date of registration: February 25, 2009.",2020,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.",['143 subjects (age\u202f>\u202f18; BMI\u202f≥\u202f27\u202fkg/m 2 '],"['lifestyle intervention', 'ACE-2']","['Insulin sensitivity (IS', 'ACE-2  AT  (ΔACE-2 AT ', 'degree of changes in insulin resistance', 'Weight loss', 'ISI Clamp', 'ACE-2 mRNA expression (ACE-2 AT ']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",143.0,0.0156104,"A smaller reduction of ACE-2  AT  (ΔACE-2 AT ) was associated with a larger improvement of ISI Clamp  (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss.","[{'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Soll', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Finja', 'Initials': 'F', 'LastName': 'Beer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brachs', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Spranger', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany. Electronic address: joachim.spranger@charite.de.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117 Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117 Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Berlin, Germany; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Research Unit, 10117 Berlin, Germany.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154401']
3480,33065191,A randomized controlled trial testing the effects of a positive front-of-pack label with or without a physical activity equivalent label on food purchases.,"BACKGROUND


Positive front-of-pack (FOP) labels, including Singapore's Healthier Choice Symbol (HCS), target a subset of healthier products whose consumption is to be encouraged. However, this may inadvertently lead to excess caloric intake, which could be addressed by including an additional label identifying calories per serving. We test this hypothesis by adding a Physical Activity Equivalent (PAE) label, an indicator of calorie content, to all products available in an on-line grocery store.
METHODS


We conducted a randomized controlled trial using a 3 arm within-subject crossover design in adult Singapore residents recruited online. Participants shopped once in each condition in an experimental online grocery store in random order: 1) no FOP label (Control); 2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE). 117 participants were recruited and data from 317 shops were analyzed. We used first-differenced regressions to assess the impact of the conditions on calories per serving (primary) and on other measures of diet quality.
RESULTS


The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%). However, neither the HCS-only (3.45; 95% CI, -12.52: 19.43) nor HCS + PAE (8.14; 95% CI, -5.25: 21.54) condition led to a change in the number of calories per serving purchased or changes in other measures of diet quality.
CONCLUSIONS


Positive labels, like the HCS, are likely to increase purchases of labelled products. However, these changes may not lead to improvements in diet quality or calorie intake. Combining positive labels with additional PAE information does not appear to address this concern.",2020,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","['117 participants were recruited and data from 107 shops were analyzed', 'adult Singapore residents who were recruited online']","['Physical Activity Equivalent (PAE) label', 'Positive Front-of-Pack Label', 'FOP label (Control', '2) Select products displaying HCS labels (HCS-only); 3) Condition 2 with additional information displaying PAEs per serving on every product (HCS+PAE', ""positive FOP label, Singapore's Healthier Choice Symbol (HCSs""]",['diet quality or calorie intake'],"[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0010996', 'cui_str': 'Information Display'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",117.0,0.203633,"The HCS-only condition led to a statistically significant five-percentage point increase in the proportion of HCS products purchased (95% CI, 1%: 9%).","[{'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore. Electronic address: eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Doble', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Felicia Jia Ler', 'Initials': 'FJL', 'LastName': 'Ang', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Wei Han Melvin', 'Initials': 'WHM', 'LastName': 'Wong', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Rob M', 'Initials': 'RM', 'LastName': 'van Dam', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}]",Appetite,['10.1016/j.appet.2020.104997']
3481,30566030,Dalfampridine benefits ambulation but not cognition in multiple sclerosis.,"BACKGROUND


Impaired cognition and ambulation are common in multiple sclerosis (MS). Dalfampridine is the first Food and Drug Administration (FDA)-approved medication to treat impaired ambulation in MS. Dalfampridine may benefit patients with cognitive impairment, given its effects on saltatory conduction and the association between cognitive and motor function.
OBJECTIVE


To examine the effects of dalfampridine on cognition in MS. To determine if the anticipated improved cognition is grounded in dalfampridine's effects on ambulation.
METHODS


Adults with MS were randomized to dalfampridine ( n  = 45) or placebo ( n  = 16) for 12 weeks. Cognition and motor function were assessed at baseline and end-point.
RESULTS


T25FW and 6-minute walk (6MW) performance improved at end-point in the treatment group but not in the placebo group ( p  < 0.05). Our primary outcome, performance on the Symbol Digit Modalities Test, did not improve. About 30% ( n  = 12) of the dalfampridine group demonstrated ⩾20% improved ambulation and were categorized ""responders."" Among ""responders"", Symbol Digit Modalities test performance did not improve. However, performance on the Paced Auditory Serial Addition Test improved among ""responders"" ( p  < 0.05).
CONCLUSION


Dalfampridine benefits timed ambulation but not cognition. Some improvement among ambulation ""responders"" is consistent with prior reports of cognition-motor coupling in MS ( ClinicalTrials.gov #: NCT02006160).",2020,"However, performance on the Paced Auditory Serial Addition Test improved among ""responders"" ( p < 0.05).
",['Adults with MS'],"['dalfampridine', 'Dalfampridine', 'placebo']","['T25FW and 6-minute walk (6MW) performance', 'Cognition and motor function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000477', 'cui_str': 'fampridine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",,0.0494253,"However, performance on the Paced Auditory Serial Addition Test improved among ""responders"" ( p < 0.05).
","[{'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Satchidanand', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Drake', 'Affiliation': 'Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Smerbeck', 'Affiliation': 'Rochester Institute of Technology, Rochester, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hojnacki', 'Affiliation': 'Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Channa', 'Initials': 'C', 'LastName': 'Kolb', 'Affiliation': 'Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Weinstock-Guttman', 'Affiliation': 'Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ralph Hb', 'Initials': 'RH', 'LastName': 'Benedict', 'Affiliation': 'Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, NY, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518815795']
3482,30503740,The Surgical Treatment for Ischemic Heart Failure trial: A landmark study.,,2019,,[],[],[],[],[],[],,0.0221053,,"[{'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Crestanello', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn. Electronic address: crestanello.juan@mayo.edu.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Daly', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minn.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2018.10.066']
3483,4380322,"A controlled trial of A.N.P. 235 (""Lucidril"") in senile dementia.",,1966,,['senile dementia'],[],[],"[{'cui': 'C0011268', 'cui_str': 'Senile dementia (disorder)'}]",[],[],,0.0527052,,"[{'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Bower', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'McDonald', 'Affiliation': ''}]",The Medical journal of Australia,[]
3484,18620642,[Are circular and reflexive techniques useful in clinical interviews with the family doctor?].,,2008,,[],[],[],[],[],[],,0.017355,,"[{'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Boxó Cifuentes', 'Affiliation': ''}]",Atencion primaria,[]
3485,30902198,Randomized studies for Barrett's ablation: just because we can doesn't mean we should.,,2019,,[],[],[],[],[],[],,0.0231155,,"[{'ForeName': 'Sanne Noortje', 'Initials': 'SN', 'LastName': 'van Munster', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Roos E', 'Initials': 'RE', 'LastName': 'Pouw', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Jacques J G H M', 'Initials': 'JJGHM', 'LastName': 'Bergman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2018.11.007']
3486,31931509,The acute effects of nicotine on corticostriatal responses to distinct phases of reward processing.,"Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues. This anticipatory effect is selective as no clear evidence has emerged showing that nicotine acutely changes reward receipt reactivity. However, repeated rewarding experiences shift peak brain reactivity from hedonic reward outcome to the motivational anticipatory cue yielding more habitual cue-induced behavior. Given nicotine's influence on NAcc reactivity and connectivity, it is plausible that nicotine acutely induces this shift and alters NAcc functional connectivity during reward processing. To evaluate this currently untested hypothesis, a randomized crossover design was used in which healthy non-smokers were administered placebo and nicotine (2-mg lozenge). Brain activation to monetary reward anticipation and outcome was evaluated with functional magnetic resonance imaging. Relative to placebo, nicotine induced more NAcc reactivity to reward anticipation. Greater NAcc activation during anticipation was significantly associated with lower NAcc activation to outcome. During outcome, nicotine reduced NAcc functional connectivity with cortical regions including the anterior cingulate cortex, orbitofrontal cortex, and insula. These regions showed the same negative relationship between reward anticipation and outcome as noted in the NAcc. The current findings significantly improve our understanding of how nicotine changes corticostriatal circuit function and communication during distinct phases of reward processing and critically show that these alterations happen acutely following a single dose. The implications of this work explain nicotinic modulation of general reward function, which offer insights into the initial drive to smoke and the subsequent difficulty in cessation.",2020,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,['healthy non-smokers'],"['nicotine', 'Nicotine', 'placebo and nicotine (2-mg lozenge', 'placebo, nicotine']","['anterior cingulate cortex, orbitofrontal cortex, and insula', 'Greater NAcc activation', 'habitual cue-induced behavior']","[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0321595,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,"[{'ForeName': 'Kainan S', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zegel', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Molokotos', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Lauren V', 'Initials': 'LV', 'LastName': 'Moran', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Olson', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA. ajanes@mclean.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0611-5']
3487,32109638,"Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.",,2020,,['Patients with Active Ulcerative Colitis'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]",[],[],,0.0747077,,"[{'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Nittala', 'Affiliation': 'Department of Gastroenterology, Institute of Medical Sciences (IMS) and SUM Hospital, Siksha O Anusandhan, Deemed to be University, Bhubaneswar, Odisha, India.'}, {'ForeName': 'Ayaskanta', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology, Institute of Medical Sciences (IMS) and SUM Hospital, Siksha O Anusandhan, Deemed to be University, Bhubaneswar, Odisha, India.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.038']
3488,31493958,How do perceptions of verbal statements and nonverbal actions as empathetic differ by medical appointment context?,"OBJECTIVE


Empathy is a crucial component of the provider-patient relationship. This research tested a list of 18 verbal statements and 21 nonverbal actions, which healthcare providers can use to provide empathy.
METHODS


Prior to rating the statements and behaviors for empathy, 466 participants were randomly assigned in an online experiment in which participants were asked to imagine they were in a medical appointment where they were experiencing either general stress, receiving bad news, or learning of a medical error which made them become emotional.
RESULTS


Results indicated the most highly rated statement was ""My entire staff is here for you."" The most highly rated nonverbal action was spending extra time with the patient. Expectations of empathy were found to rise with severity of context.
CONCLUSIONS


This research found statements/actions of empathy can be tailored to the context of the appointment.
PRACTICE IMPLICATIONS


This research can be used to provide concrete examples regarding the frequently offered advice that physicians provide empathy to their patients.",2020,"Expectations of empathy were found to rise with severity of context.
",['466 participants'],"['general stress, receiving bad news, or learning of a medical error which made them become emotional']",[],[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0376531', 'cui_str': 'Medical Mistakes'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",[],466.0,0.023553,"Expectations of empathy were found to rise with severity of context.
","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Nazione', 'Affiliation': 'Berry College Department of Communication, P.O. Box 299 Berry College, Mt. Berry, Georgia 30149, USA. Electronic address: snazione@berry.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Nazione', 'Affiliation': 'Floyd Family Medicine Residency, 304 Shorter Ave NW #201, Rome, GA, 30165, USA. Electronic address: anazione@floyd.org.'}, {'ForeName': 'Trent', 'Initials': 'T', 'LastName': 'Griner', 'Affiliation': 'Berry College Department of Communication, P.O. Box 299 Berry College, Mt. Berry, Georgia 30149, USA. Electronic address: Trent.Griner@vikings.berry.edu.'}]",Patient education and counseling,['10.1016/j.pec.2019.08.016']
3489,31630532,The challenge of non-adherence to early rehabilitation after coronary artery bypass surgery: Secondary results from the SheppHeartCABG trial.,"BACKGROUND


Attending and maintaining a cardiac rehabilitation programme is a challenge.
AIMS


The purpose of this study was to explore associations between non-adherence to early coronary artery bypass graft rehabilitation and sociodemographic and clinical baseline data.
METHODS


Coronary artery bypass graft patients were randomised 1:1 to either four weeks of comprehensive early rehabilitation or usual care. Outcomes were assessed at three time-points points: baseline, discharge and four weeks post-coronary artery bypass graft. Differences in sociodemographic and clinical baseline data in adherent versus non-adherent patients were tested using the Pearson  χ 2  test for categorical variables. To test associations between non-adherence to exercise training and sociodemographic and clinical baseline data, multivariate logistic regression was used to estimate the odds ratio for in-hospital training and post-discharge training adjusted for age, sex and left ventricular ejection fraction.
RESULTS


Non-adherence to in-hospital versus post-discharge exercise training was 31% ( n =48) versus 53% ( n =81). Female non-adherence was 20% versus 70%. Non-adherence to in-hospital versus post-discharge mindfulness was 87% versus 70%. Male non-adherence to mindfulness was 85% versus 70%. Non-adherence to psycho-educational consultations was 3%, most of whom were men. Patients with university level education were more adherent to in-hospital exercise training than patients with lower educational level (odds ratio=3.14 (95% confidence interval; 1.16-8.51),  p =0.02). Diabetic patients were more non-adherent to exercise training after discharge (3.74 (1.54-9.08),  p =0.004) as were overweight patients (0.37 (0.17-0.80),  p =0.01).
CONCLUSIONS


This study demonstrated wide acceptance of psycho-educational consultations in post-coronary artery bypass graft patients. Adherence to physical rehabilitation was low especially after discharge from hospital and the opportunity to attend a mindfulness programme was not used.",2020,Non-adherence to in-hospital versus post-discharge exercise training was 31% ( n =48) versus 53% ( n =81).,"['post-coronary artery bypass graft patients', 'Diabetic patients', 'Coronary artery bypass graft patients']","['coronary artery bypass surgery', 'psycho-educational consultations', 'comprehensive early rehabilitation or usual care', 'hospital exercise training', 'post-discharge exercise training']",[],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",[],,0.0896492,Non-adherence to in-hospital versus post-discharge exercise training was 31% ( n =48) versus 53% ( n =81).,"[{'ForeName': 'Ida E', 'Initials': 'IE', 'LastName': 'Højskov', 'Affiliation': 'The Heart Centre, University of Copenhagen, Denmark.'}, {'ForeName': 'Lau C', 'Initials': 'LC', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Denmark.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Moons', 'Affiliation': 'Department of Public Health and Primary Care, University of Leuven, Belgium.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Egerod', 'Affiliation': 'Department of Intensive Care Unit, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Olsen', 'Affiliation': 'The Heart Centre, University of Copenhagen, Denmark.'}, {'ForeName': 'Selina K', 'Initials': 'SK', 'LastName': 'Berg', 'Affiliation': 'The Heart Centre, University of Copenhagen, Denmark.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119883454']
3490,31910861,Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed.,"The evidence base available to trialists to support trial process decisions-e.g. how best to recruit and retain participants, how to collect data or how to share the results with participants-is thin. One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. These are self-contained research studies embedded within a host trial that aim to evaluate or explore alternative ways of delivering or organising a particular trial process.SWATs are increasingly being supported by funders and considered by trialists, especially in the UK and Ireland. At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial? A framework for answering such a question is needed to avoid SWATs themselves contributing to research waste.This paper presents criteria on when enough evidence is available for SWATs that use randomised allocation to compare different interventions.",2020,"At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial?",[],[],[],[],[],[],,0.103623,"At some point, increasing SWAT evidence will lead funders and trialists to ask: given the current body of evidence for a SWAT, do we need a further evaluation in another host trial?","[{'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Treweek', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK. streweek@mac.com.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bevan', 'Affiliation': 'National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'MRC North West Hub for Trials Methodology Research, Centre for Primary Care and Health Services Research, University of Manchester, Manchester, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Briel', 'Affiliation': 'Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'Christie', 'Affiliation': 'GSK Medicines Research Centre, Stevenage, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Collett', 'Affiliation': 'Health Research Authority, London, UK.'}, {'ForeName': 'Seonaidh', 'Initials': 'S', 'LastName': 'Cotton', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'El Feky', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Galvin', 'Affiliation': 'HRB-Trials Methodology Research Network, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Gardner', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gillies', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'Division of Acute Care Surgery, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Adwoa', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Restrup', 'Affiliation': 'Public and patient representative, Aberdeen, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, St Andrews University, St Andrews, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Tremain', 'Affiliation': 'National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'von Elm', 'Affiliation': 'Cochrane Switzerland, Institute of Social and Preventive Medicine (IUMSP), Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Westmore', 'Affiliation': 'National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, Southampton, UK.'}, {'ForeName': 'Hywel', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': ""Centre of Evidence-Based Dermatology, Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'MRC North West Hub for Trials Methodology Research, Department of Biostatistics University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Northern Ireland Methodology Hub, Queen's University Belfast, Belfast, UK.""}]",Trials,['10.1186/s13063-019-3980-5']
3491,32197915,Post-antibiotic Ocular Surface Microbiome in Children: A Cluster-Randomized Trial.,,2020,,['Children'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],,0.0653268,,"[{'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California. Electronic address: Thuy.Doan@ucsf.edu.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Worden', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Nisha R', 'Initials': 'NR', 'LastName': 'Acharya', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California San Francisco, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California.'}]",Ophthalmology,['10.1016/j.ophtha.2020.02.014']
3492,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1']
3493,32046611,How do people with rheumatoid arthritis experience participation in a smoking cessation trial: a qualitative study.,"Purpose : The aim of this study was to gain more knowledge on how people with rheumatoid arthritis (RA) experienced participation in a randomized controlled trial (RCT) testing the effect of a smoking cessation intervention since this intervention have not been tested on an RA population before Methods : We conducted a qualitative study with semi-structured individual interviews with 12 participants from the intervention group in the RCT. Results : Through thematic analysis we identified four themes:  Instilling hope for smoking cessation , referring to the initial invitation to participate in the RCT;  Various components of importance in the intervention , referring to cooperation with the smoking cessation counsellor, improved carbon monoxide levels, fear of becoming addicted to nicotine replacement therapy, and suggestions for additional components in the intervention which could promote motivation;  Breaking habits , referring to ongoing reflection on quitting smoking; and  Increased awareness of health, arthritis and smoking , referring to the lack of information on smoking and RA from health professionals, and the impact of smoking on RA symptoms and overall health. Conclusion : The results reflect the participants' perspective on what is meaningful to them when trying to quit smoking and adds important knowledge to future smoking cessation studies in this patient group.",2020,Through thematic analysis we identified four themes:  ,['people with rheumatoid arthritis (RA'],['smoking cessation intervention'],[],"[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],12.0,0.0246675,Through thematic analysis we identified four themes:  ,"[{'ForeName': 'Ida Kristiane', 'Initials': 'IK', 'LastName': 'Roelsgaard', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Thordis', 'Initials': 'T', 'LastName': 'Thomsen', 'Affiliation': 'Herlev Anaesthesia Critical and Emergency Care Science Unit, ACES, Department of Anesthesiology, Copenhagen University Hospital, Herlev-Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Anne Grete', 'Initials': 'AG', 'LastName': 'Semb', 'Affiliation': 'Preventive Cardio-Rheuma Clinic, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Andersen', 'Affiliation': 'The Danish Rheumatism Association, Gentofte, Denmark.'}, {'ForeName': 'Bente Appel', 'Initials': 'BA', 'LastName': 'Esbensen', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark.'}]",International journal of qualitative studies on health and well-being,['10.1080/17482631.2020.1725997']
3494,32106129,"Reply to the Letter to the Editor: The ""Cough Trick"" Reduces Pain During Removal of Closed-suction Drains after Total Knee Arthroplasty: A Randomized Trial.",,2020,,['after Total Knee Arthroplasty'],"['Cough Trick"" Reduces Pain During Removal of Closed-suction Drains']",[],"[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0441139', 'cui_str': 'Suction drain (physical object)'}]",[],,0.0338824,,"[{'ForeName': 'Varah', 'Initials': 'V', 'LastName': 'Yuenyongviwat', 'Affiliation': 'V. Yuenyongviwat, K. Iamthanaporn, P. Tuntarattanapong, T. Hongnaparak, Department of Orthopedics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Khanin', 'Initials': 'K', 'LastName': 'Iamthanaporn', 'Affiliation': ''}, {'ForeName': 'Pakjai', 'Initials': 'P', 'LastName': 'Tuntarattanapong', 'Affiliation': ''}, {'ForeName': 'Theerawit', 'Initials': 'T', 'LastName': 'Hongnaparak', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001205']
3495,32118608,CORR Insights®: Can an Integrative Care Approach Improve Physical Function Trajectories after Orthopaedic Trauma? A Randomized Controlled Trial.,,2020,,[],[],['Physical Function Trajectories'],[],[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.12488,,"[{'ForeName': 'Julius A', 'Initials': 'JA', 'LastName': 'Bishop', 'Affiliation': 'J. A. Bishop, Associate Professor, Stanford University Medical Center, Department of Orthopaedic Surgery, Redwood City, CA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001195']
3496,32174130,Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART).,"BACKGROUND


The future risk of myocardial infarction is commonly assessed using cardiovascular risk scores, coronary artery calcium score, or coronary artery stenosis severity. We assessed whether noncalcified low-attenuation plaque burden on coronary CT angiography (CCTA) might be a better predictor of the future risk of myocardial infarction.
METHODS


In a post hoc analysis of a multicenter randomized controlled trial of CCTA in patients with stable chest pain, we investigated the association between the future risk of fatal or nonfatal myocardial infarction and low-attenuation plaque burden (% plaque to vessel volume), cardiovascular risk score, coronary artery calcium score or obstructive coronary artery stenoses.
RESULTS


In 1769 patients (56% male; 58±10 years) followed up for a median 4.7 (interquartile interval, 4.0-5.7) years, low-attenuation plaque burden correlated weakly with cardiovascular risk score ( r =0.34;  P <0.001), strongly with coronary artery calcium score ( r =0.62;  P <0.001), and very strongly with the severity of luminal coronary stenosis (area stenosis,  r =0.83;  P <0.001). Low-attenuation plaque burden (7.5% [4.8-9.2] versus 4.1% [0-6.8];  P <0.001), coronary artery calcium score (336 [62-1064] versus 19 [0-217] Agatston units;  P <0.001), and the presence of obstructive coronary artery disease (54% versus 25%;  P <0.001) were all higher in the 41 patients who had fatal or nonfatal myocardial infarction. Low-attenuation plaque burden was the strongest predictor of myocardial infarction (adjusted hazard ratio, 1.60 (95% CI, 1.10-2.34) per doubling;  P =0.014), irrespective of cardiovascular risk score, coronary artery calcium score, or coronary artery area stenosis. Patients with low-attenuation plaque burden greater than 4% were nearly 5 times more likely to have subsequent myocardial infarction (hazard ratio, 4.65; 95% CI, 2.06-10.5;  P <0.001).
CONCLUSIONS


In patients presenting with stable chest pain, low-attenuation plaque burden is the strongest predictor of fatal or nonfatal myocardial infarction. These findings challenge the current perception of the supremacy of current classical risk predictors for myocardial infarction, including stenosis severity. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01149590.",2020,,['Myocardial Infarction'],[],[],"[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",[],[],,0.0330488,,"[{'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kwiecinski', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Doris', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'McElhinney', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': ""D'Souza"", 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Cadet', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Moss', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Shirjel', 'Initials': 'S', 'LastName': 'Alam', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Pawade', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Chengjia', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weir McCall', 'Affiliation': 'University of Cambridge, United Kingdom (J.W.M.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bonnici-Mallia', 'Affiliation': 'Department of Radiology, Ninewells Hospital, Dundee, United Kingdom (M.B-M., C.M.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Murrills', 'Affiliation': 'Department of Radiology, Ninewells Hospital, Dundee, United Kingdom (M.B-M., C.M.).'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Institute of Clinical Sciences, University of Glasgow, United Kingdom (G.R.).'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Weill Cornell Medical College, New York, NY (L.J.S.).'}, {'ForeName': 'Edward D', 'Initials': 'ED', 'LastName': 'Nicol', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust Departments of Cardiology and Radiology; and the National Heart and Lung Institute, Faculty of Medicine, Imperial College, London, United Kingdom (E.D.N.).'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'Piotr J', 'Initials': 'PJ', 'LastName': 'Slomka', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': ""University/BHF Centre for Cardiovascular Science (M.C.W., J.K., M.D., M.S.D'S., P.D.A., A.J.M., S.A., A.H., A.S.V.S., N.L.M., T.P., C.W., E.J.R.v.B., D.E.N., M.R.D.), University of Edinburgh, United Kingdom.""}, {'ForeName': 'Damini', 'Initials': 'D', 'LastName': 'Dey', 'Affiliation': 'Cedars-Sinai Medical Centre, Los Angeles, CA (P.M., S.C., P.J.S., D.S.B., D.D.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044720']
3497,29369680,Prospect theory reflects selective allocation of attention.,"There is a disconnect in the literature between analyses of risky choice based on cumulative prospect theory (CPT) and work on predecisional information processing. One likely reason is that for expectation models (e.g., CPT), it is often assumed that people behaved only as if they conducted the computations leading to the predicted choice and that the models are thus mute regarding information processing. We suggest that key psychological constructs in CPT, such as loss aversion and outcome and probability sensitivity, can be interpreted in terms of attention allocation. In two experiments, we tested hypotheses about specific links between CPT parameters and attentional regularities. Experiment 1 used process tracing to monitor participants' predecisional attention allocation to outcome and probability information. As hypothesized, individual differences in CPT's loss-aversion, outcome-sensitivity, and probability-sensitivity parameters (estimated from participants' choices) were systematically associated with individual differences in attention allocation to outcome and probability information. For instance, loss aversion was associated with the relative attention allocated to loss and gain outcomes, and a more strongly curved weighting function was associated with less attention allocated to probabilities. Experiment 2 manipulated participants' attention to losses or gains, causing systematic differences in CPT's loss-aversion parameter. This result indicates that attention allocation can to some extent cause choice regularities that are captured by CPT. Our findings demonstrate an as-if model's capacity to reflect characteristics of information processing. We suggest that the observed CPT-attention links can be harnessed to inform the development of process models of risky choice. (PsycINFO Database Record",2018,"For instance, loss aversion was associated with the relative attention allocated to loss and gain outcomes, and a more strongly curved weighting function was associated with less attention allocated to probabilities.",[],[],"[""CPT's loss-aversion, outcome-sensitivity, and probability-sensitivity parameters""]",[],[],"[{'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",1.0,0.0830092,"For instance, loss aversion was associated with the relative attention allocated to loss and gain outcomes, and a more strongly curved weighting function was associated with less attention allocated to probabilities.","[{'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Pachur', 'Affiliation': 'Center for Adaptive Rationality, Max Planck Institute for Human Development.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schulte-Mecklenbeck', 'Affiliation': 'Department of Business Administration and Consumer Behavior, University of Bern.'}, {'ForeName': 'Ryan O', 'Initials': 'RO', 'LastName': 'Murphy', 'Affiliation': 'Morningstar.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hertwig', 'Affiliation': 'Center for Adaptive Rationality, Max Planck Institute for Human Development.'}]",Journal of experimental psychology. General,['10.1037/xge0000406']
3498,30598280,Extent of lymphadenectomy for esophageal squamous cell cancer: Interpreting the post-hoc analysis of a randomized trial.,,2019,,['esophageal squamous cell cancer'],['lymphadenectomy'],[],"[{'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}]","[{'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}]",[],,0.043959,,"[{'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Division of General Surgery, Department of Surgery and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada. Electronic address: Vaibhav.Gupta@mail.utoronto.ca.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2018.11.055']
3499,31411989,"Re: Christopher C. Parker, Nicholas D. James, Christopher D. Brawley, et al. Radiotherapy to the Primary Tumour for Newly Diagnosed, Metastatic Prostate Cancer (STAMPEDE): A Randomised Controlled Phase 3 Trial. Lancet 2018;392:2353-66: Metastatic Hormone-naïve Prostate Cancer: A Multimodal Approach for a Heterogeneous Disease.",,2020,,"['Metastatic Hormone-naïve Prostate Cancer', 'Newly Diagnosed, Metastatic Prostate Cancer (STAMPEDE']",['Radiotherapy'],[],"[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]",[],,0.0310658,,"[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Nunno', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Santoni', 'Affiliation': 'Oncology Unit, Macerata Hospital, Macerata, Italy.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gatto', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}]",European urology oncology,['10.1016/j.euo.2019.02.005']
3500,31222977,Randomized parallel control trial checking the efficacy and impact of two concentrations of retinol in the original formula on the aging skin condition: Pilot study.,"BACKGROUND


The aging process is defined as natural, biological, progressive, and physiologically irreversible phenomena occurring in the body.
OBJECTIVE


We attempted to evaluate the efficacy and tolerability of treating signs of the aging skin using retinol 0.15% and 0.3%. Retinol was added to the original, developed liquid crystal formula.
METHODS


Patients at two sites (n = 20, n = 20) presenting signs of aging applied a novel formulation of retinol at 0.15% (on the left) and 0.3% (on the right) concentrations daily to their faces for 2 months. An expert blinded evaluation of images was carried out after 8 weeks. Tolerability was assessed throughout the whole study. Positive results of the observational pilot study guaranteed a follow-up trial with the use of the higher concentration and another parallel study.
RESULTS


In the observational pilot study, most of the participants showed an improvement in the overall skin condition. These improvements were assessed after 4 and 8 weeks. Those observed after 56 days were more remarkable than those identified 28 days, however, without any statistical significance. Application of retinol formula 0.3% and serum 0.15% gives similar results after 8 weeks of daily care. Both products improve the overall skin condition considerably, even the skin color, hydration, and radiance. In a VAS assessment, the number of wrinkles decreased and skin discoloration was reduced. Side effects such as burning, dryness, pruritus, and erythema during the 8-week study period were minimal.
CONCLUSIONS


The topical formulation of liquid crystal serum with retinol 0.15% and 0.3% improves the overall skin condition after 8 weeks. Burning, pruritus, dryness, and erythema caused by the application of retinol 0.15% and 0.3% concentrations were minimal. Nevertheless, there were no significance changes found between the left and right side of the face. These encouraging results justify a longer-term study to determine whether topically applied retinol 0.3% can provide more benefits as compared to those observed after topical application of retinol 0.15%.",2020,"Burning, pruritus, dryness, and erythema caused by the application of retinol 0.15% and 0.3% concentrations were minimal.","['Patients at two sites (n\xa0=\xa020, n\xa0']",['Retinol'],"['efficacy and tolerability', 'number of wrinkles decreased and skin discoloration', 'Burning, pruritus, dryness, and erythema', 'burning, dryness, pruritus, and erythema', 'overall skin condition', 'Tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin (finding)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1719933', 'cui_str': 'Skin condition'}]",,0.0242256,"Burning, pruritus, dryness, and erythema caused by the application of retinol 0.15% and 0.3% concentrations were minimal.","[{'ForeName': 'Malwina', 'Initials': 'M', 'LastName': 'Zasada', 'Affiliation': 'Department of Cosmetic Raw Materials Chemistry, Faculty of Pharmacy, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Budzisz', 'Affiliation': 'Department of Cosmetic Raw Materials Chemistry, Faculty of Pharmacy, Medical University of Lodz, Lodz, Poland.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13040']
3501,32223322,Alcohol and heart health: The need for a randomized controlled trial.,,2020,,[],[],['Alcohol and heart health'],[],[],"[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.153134,,"[{'ForeName': 'Dag S', 'Initials': 'DS', 'LastName': 'Thelle', 'Affiliation': 'Department of Biostatistics, Institute of Basic Medical Sciences, University of Oslo, Norway.'}]",European journal of preventive cardiology,['10.1177/2047487320914433']
3502,32250171,The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk.,"BACKGROUND


Observational studies have documented lower risks of coronary heart disease and diabetes among moderate alcohol consumers relative to abstainers, but only a randomized clinical trial can provide conclusive evidence for or against these associations.
AIM


The purpose of this study was to describe the rationale and design of the Moderate Alcohol and Cardiovascular Health Trial, aimed to assess the cardiometabolic effects of one alcoholic drink daily over an average of six years among adults 50 years or older.
METHODS


This multicenter, parallel-arm randomized trial was designed to compare the effects of one standard serving (∼11-15 g) daily of a preferred alcoholic beverage to abstention. The trial aimed to enroll 7800 people at high risk of cardiovascular disease. The primary composite endpoint comprised time to the first occurrence of non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalized angina, coronary/carotid revascularization, or total mortality. The trial was designed to provide >80% power to detect a 15% reduction in the risk of the primary outcome. Secondary outcomes included diabetes. Adverse effects of special interest included injuries, congestive heart failure, alcohol use disorders, and cancer.
RESULTS


We describe the design, governance, masking issues, and data handling. In three months of field center activity until termination by the funder, the trial randomized 32 participants, successfully screened another 70, and identified ∼400 additional interested individuals.
CONCLUSIONS


We describe a feasible design for a long-term randomized trial of moderate alcohol consumption. Such a study will provide the highest level of evidence for the effects of moderate alcohol consumption on cardiovascular disease and diabetes, and will directly inform clinical and public health guidelines.",2020,,[],[],[],[],[],[],,0.0302903,,"[{'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Polyna', 'Initials': 'P', 'LastName': 'Khudyakov', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Trine L', 'Initials': 'TL', 'LastName': 'Wilkens', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Clement A', 'Initials': 'CA', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Sally N', 'Initials': 'SN', 'LastName': 'Adebamowo', 'Affiliation': 'Department of Epidemiology and Public Health, Greenebaum Comprehensive Cancer Center, University of Maryland, School of Medicine, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Joline Wj', 'Initials': 'JW', 'LastName': 'Beulens', 'Affiliation': 'Amsterdam UMC - location VUmc, Amsterdam Cardiovascular Sciences Research Institute, Netherlands.'}, {'ForeName': 'Janelle W', 'Initials': 'JW', 'LastName': 'Coughlin', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Lars Ove', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Edenberg', 'Affiliation': 'Indiana University School of Medicine, USA.'}, {'ForeName': 'Jane N', 'Initials': 'JN', 'LastName': 'Eriksen', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'CIBER de Fisiopatología de la Obesidad y la Nutricion (CIBEROBN), Instituto de Salud Carlos III, Spain.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Julius Clinical, Netherlands.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Lazo', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins ProHealth Clinical Research Center, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Murray', 'Affiliation': 'Yale University School of Medicine, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Rimm', 'Affiliation': 'Harvard TH Chan School of Public Health, USA.'}, {'ForeName': 'Ilse C', 'Initials': 'IC', 'LastName': 'Schrieks', 'Affiliation': 'Department of Internal Medicine, Hospital Clínic, IDIBAPS August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Spain.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Wake Forest School of Medicine, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': ""Channing Laboratory, Brigham and Women's Hospital, Harvard Medical School, USA.""}]",European journal of preventive cardiology,['10.1177/2047487320912376']
3503,14467552,"A pilot clinical trial of ""Persantin"".",,1961,,[],[],[],[],[],[],,0.0695849,,"[{'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'LYALL', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'BARNETT', 'Affiliation': ''}]",The Medical journal of Australia,[]
3504,31882240,Tibetan Medicated Bathing Therapy for Patients With Post-stroke Limb Spasticity: A Randomized Controlled Clinical Trial.,"OBJECTIVE


To determine the short- (4 weeks) and long-term (6 month) effectiveness of Tibetan medicated bathing therapy in patients with post-stroke limb spasticity.
DESIGN


Prospective, blinded, randomized controlled trial.
SUBJECTS


Post-stroke patients with limb spasticity were recruited between December 2013 and February 2017 and randomly assigned 1:1 to a control group that received conventional rehabilitation (n = 222) or an experimental group that received Tibetan medicated bathing therapy in combination with conventional rehabilitation (n = 222).
METHODS


All patients received conventional rehabilitation. In addition, the experimental group received Tibetan medicated bathing therapy. The interventions were conducted 5 times per week for 4 weeks. The primary endpoint was changes from baseline after 4 weeks of therapy in muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors), as measured by the Modified Ashworth Scale (MAS).
RESULTS


The mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P = .017), wrist flexors (P < .001), and ankle plantar flexors (P < .001) was significantly greater in patients in the experimental group compared to the control group. The benefit was maintained for 3 muscle groups (elbow flexors P < .001, wrist flexors P = .001, and ankle plantar flexors P < .001) and 6 months (elbow flexors P < .001, wrist flexors P = .002, and ankle plantar flexors P < .001) after therapy. All adverse events were mild, and no serious adverse reactions to Tibetan medicated bathing therapy were recorded.
CONCLUSIONS AND IMPLICATIONS


Tibetan medicated bathing therapy, in combination with conventional rehabilitation, has potential as a safe, effective treatment for the alleviation of post-stroke upper limb spasticity. Tibetan medicated bathing therapy was most advantageous for patients who had a baseline muscle tone score of 1+ to 2 on the MAS in the affected limb and recent onset of stroke (duration of the disease of 1-3 months).",2020,"The mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P = .017), wrist flexors (P < .001), and ankle plantar flexors (P < .001) was significantly greater in patients in the experimental group compared to the control group.","['Patients With Post-stroke Limb Spasticity', 'Post-stroke patients with limb spasticity were recruited between December 2013 and February 2017', 'patients with post-stroke limb spasticity']","['conventional rehabilitation (n\xa0= 222) or an experimental group that received Tibetan', 'conventional rehabilitation', 'medicated bathing therapy in combination with conventional rehabilitation', 'Tibetan Medicated Bathing Therapy', 'Tibetan medicated bathing therapy']","['ankle plantar flexors P', 'ankle plantar flexors', 'muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors), as measured by the Modified Ashworth Scale (MAS', 'wrist flexors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}]",,0.0583975,"The mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P = .017), wrist flexors (P < .001), and ankle plantar flexors (P < .001) was significantly greater in patients in the experimental group compared to the control group.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China; The Second Clinical Medical School, Nanjing University of Chinese Medicine, Jiangsu, China.'}, {'ForeName': 'Shouguo', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Zhihang', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'The Teaching and Research Department of Statistics, Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Rehabilitation Center, The Second Affiliated Hospital of HaiNan Medical University, Hainan, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'The Rehabilitation Department, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan, China.'}, {'ForeName': 'Yihuang', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'The Second Clinical Medical School, Nanjing University of Chinese Medicine, Jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'The Acupuncture Rehabilitation Department, Jiangsu Province Hospital of Traditional Chinese Medicine, Jiangsu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Rehabilitation Center, The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Heilongjiang, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'The Rehabilitation Department, Guangdong Provincial Traditional Chinese Medicine Hospital, Guangdong, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'The Rehabilitation Department, Tongji Medical College Huazhong University of Science & Technology, Hubei, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'The Neurological Rehabilitation Department, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Rehabilitation Center, Xuzhou Central Hospital, Jiangsu, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'The Rehabilitation Department, The Affiliated Hospital of Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'ChunXiao', 'Initials': 'C', 'LastName': 'Wan', 'Affiliation': 'The Rehabilitation Department, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Gangqi', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'The Neurology Department, Nanjing Hospital of Traditional Chinese Medicine, Jiangsu, China.'}, {'ForeName': 'Jianhu', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'The Neurology Department, Nanjing Hospital of Traditional Chinese Medicine, Jiangsu, China.'}, {'ForeName': 'Wenguang', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'The Rehabilitation Department, Hubei Provincial Hospital of Integrated Chinese & Western Medicine, Hubei, China.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Lihua Wang', 'Affiliation': 'The Rehabilitation Department, Dongguan Kanghua Hospital, Guangdong, China.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Steven Y Cheng', 'Affiliation': 'School of Basic Medical Sciences, Nanjing Medical University, Jiangsu, China. Electronic address: sycheng@njmu.edu.cn.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China. Electronic address: luxiao1972@163.com.'}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Jiangsu, China. Electronic address: jiananli77@126.com.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.10.018']
3505,31841498,Genetic variation in GC and CYP2R1 affects 25-hydroxyvitamin D concentration and skeletal parameters: A genome-wide association study in 24-month-old Finnish children.,"Vitamin D is important for normal skeletal homeostasis, especially in growing children. There are no previous genome-wide association (GWA) studies exploring genetic factors that influence vitamin D metabolism in early childhood. We performed a GWA study on serum 25-hydroxyvitamin D (25(OH)D) and response to supplementation in 761 healthy term-born Finnish 24-month-old children, who participated in a randomized clinical trial comparing effects of 10 μg and 30 μg of daily vitamin D supplementation from age 2 weeks to 24 months. Using the Illumina Infinium Global Screening Array, which has been optimized for imputation, a total of 686085 markers were genotyped across the genome. Serum 25(OH)D was measured at the end of the intervention at 24 months of age. Skeletal parameters reflecting bone strength were determined at the distal tibia at 24 months using peripheral quantitative computed tomography (pQCT) (data available for 648 children). For 25(OH)D, two strong GWA signals were identified, localizing to GC (Vitamin D binding protein) and CYP2R1 (Vitamin D 25-hydroxylase) genes. The GWA locus comprising the GC gene also associated with response to supplementation. Further evidence for the importance of these two genes was obtained by comparing association signals to gene expression data from the Genotype-Tissue Expression project and performing colocalization analyses. Through the identification of haplotypes associated with low or high 25(OH)D concentrations we used a Mendelian randomization approach to show that haplotypes associating with low 25(OH)D were also associated with low pQCT parameters in the 24-month-old children. In this first GWA study on 25(OH)D in this age group we show that already at the age of 24 months genetic variation influences 25(OH)D concentrations and determines response to supplementation, with genome-wide significant associations with GC and CYP2R1. Also, the dual association between haplotypes, 25(OH)D and pQCT parameters gives support for vertical pleiotropy mediated by 25(OH)D.",2019,"Using the Illumina Infinium Global Screening Array, which has been optimized for imputation, a total of 686085 markers were genotyped across the genome.","['24-month-old Finnish children', '761 healthy term-born Finnish 24-month-old children']","['peripheral quantitative computed tomography (pQCT', 'Vitamin D', '10 μg and 30 μg of daily vitamin D supplementation']","['Serum 25(OH)D', 'serum 25-hydroxyvitamin D (25(OH)D) and response to supplementation']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",648.0,0.0596026,"Using the Illumina Infinium Global Screening Array, which has been optimized for imputation, a total of 686085 markers were genotyped across the genome.","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kämpe', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Pekkinen', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.'}]",PLoS genetics,['10.1371/journal.pgen.1008530']
3506,32108262,Prebiotic potencial of juçara berry on changes in gut bacteria and acetate of individuals with obesity.,"PURPOSE


Whole plant foods can be fermentable by SCFA-producing bacteria and positively influence host adipose tissue development and obesity related-metabolic disorders, conferring a prebiotic role. Considering the juçara berry composition, rich in fiber and polyphenols, we hypothesized the probable prebiotic role of juçara in individuals with obesity.
METHODS


It was a randomized double-blind placebo-controlled trial with 35 volunteers with obesity I and II of both sexes aged from 31 to 59 years, divided into juçara group (5 g lyophilized juçara) or placebo group (5 g of maltodextrin) for 6 weeks. Before and after supplementation, food intake and blood and stool samples were collected to evaluate serum LPS, SCFA, and microbial bacteria.
RESULTS


Significant increase in fecal acetate (g = 0.809; p = 0.038) and in relative abundance of A. muciniphila, Bifidobacterium spp. and C. coccoides were observed in response to juçara supplementation (Δ% = 239.6%, 182.6%, and 214%, respectively), with a significant mediator role of Bifidobacterium spp. in high amounts of fecal acetate (z = 2.925; p = 0.003). To certify the prebiotic role of juçara, the averages were adjusted for total fiber intake; and there was no effect of the fiber intake on the SCFA nor on the intestinal bacteria.
CONCLUSION


Juçara berry may haveprebiotic function, with emphasis on the bifidogenic effect, leading to increased excretion of acetate.",2020,in high amounts of fecal acetate (z = 2.925; p = 0.003).,"['35 volunteers with obesity I and II of both sexes aged from 31 to 59\xa0years', 'individuals with obesity']","['placebo', 'placebo group (5\xa0g of maltodextrin']","['fecal acetate ', 'response to juçara supplementation', 'serum LPS, SCFA, and microbial bacteria']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}]",35.0,0.0810472,in high amounts of fecal acetate (z = 2.925; p = 0.003).,"[{'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Jamar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Aline Boveto', 'Initials': 'AB', 'LastName': 'Santamarina', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Breno Picin', 'Initials': 'BP', 'LastName': 'Casagrande', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Estadella', 'Affiliation': 'Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Veridiana Vera', 'Initials': 'VV', 'LastName': 'de Rosso', 'Affiliation': 'Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Departamento de Tecnologia e Ciências Dos Alimentos, Centro de Ciências Rurais, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Mariane Bittencourt', 'Initials': 'MB', 'LastName': 'Fagundes', 'Affiliation': 'Departamento de Tecnologia e Ciências Dos Alimentos, Centro de Ciências Rurais, Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.'}, {'ForeName': 'Luciana Pellegrini', 'Initials': 'LP', 'LastName': 'Pisani', 'Affiliation': 'Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil. lucianapisani@gmail.com.'}]",European journal of nutrition,['10.1007/s00394-020-02208-1']
3507,32066146,Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.,"Background


Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred.
Objective


To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo.
Design


Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333).
Setting


North America.
Participants


Adults with known cardiovascular disease and diabetes or metabolic syndrome.
Intervention


Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week.
Measurements


Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication.
Results


After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
Limitation


The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period.
Conclusion


Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased.
Primary Funding Source


National Institutes of Health.",2020,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","['6158 patients', 'patients without rheumatic disease who tolerated LD-MTX during an active run-in period', 'randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2', '2391 participants assigned to', 'Participants\n\n\nAdults with known cardiovascular disease and diabetes or metabolic syndrome']","['placebo', '\n\n\nLow-dose methotrexate (LD-MTX', 'LD-MTX', 'Low-Dose Methotrexate', 'LD-MTX versus placebo', 'folic acid']","['increased risk for skin cancer', 'Renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]",6158.0,0.678699,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Karlson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Barbhaiya', 'Affiliation': 'Hospital for Special Surgery, New York, New York (M.B.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Aruna D', 'Initials': 'AD', 'LastName': 'Pradhan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Deepak A', 'Initials': 'DA', 'LastName': 'Rao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Ritter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-3369']
3508,5334374,"Evaluation of propranolol (""Inderal"") in the treatment of angina pectoris.",,1966,,['angina pectoris'],"['propranolol (""Inderal']",[],"[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0591636', 'cui_str': 'Inderal'}]",[],,0.0146107,,"[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Nestel', 'Affiliation': ''}]",The Medical journal of Australia,[]
3509,32067629,"Impact of Biannual Azithromycin on Anemia in Preschool Children in Kilosa District, Tanzania: A Cluster-Randomized Clinical Trial.","A cluster-randomized clinical trial showed that biannual single-dose azithromycin reduced mortality in preschool children; we sought to determine the effect on anemia. A simple random sample of 30 communities from Kilosa district, Tanzania, were themselves randomized to receive either 6-monthly treatment of children aged 1-59 months with single-dose azithromycin or placebo. From each community, 40 preschool children were randomly selected at baseline, 12 months, and 24 months. At surveys, the children underwent hemoglobin testing; WHO definitions for anemia were applied. After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months. In each of the cross-sectional surveys, anemia prevalence was associated with younger age; the odds of being anemic was highest in those aged < 12 months. There was also a general decrease in the prevalence of anemia during the study. Although azithromycin was not shown to affect anemia, significantly, the study highlights burden of anemia in rural, African communities.",2020,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","['Preschool Children in Kilosa District, Tanzania', '40 preschool children', '30 communities from Kilosa district, Tanzania', 'preschool children']","['azithromycin or placebo', 'Biannual Azithromycin', 'azithromycin']","['prevalence of anemia', 'anemia prevalence']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",40.0,0.144766,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0500']
3510,31794027,Building capacity in mental health care in low- and middle-income countries by training primary care physicians using the mhGAP: a randomized controlled trial.,"To address the rise in mental health conditions in Tunisia, a training based on the Mental Health Gap Action Programme (mhGAP) Intervention Guide (IG) was offered to primary care physicians (PCPs) working in the Greater Tunis area. Non-specialists (such as PCPs)' training is an internationally supported way to target untreated mental health symptoms. We aimed to evaluate the programme's impact on PCPs' mental health knowledge, attitudes, self-efficacy and self-reported practice, immediately following and 18 months after training. We conducted an exploratory trial with a combination of designs: a pretest-posttest control group design and a one-group pretest-posttest design were used to assess the training's short-term impact; and a repeated measures design was used to assess the training's long-term impact. The former relied on a delayed-intervention strategy: participants assigned to the control group (Group 2) received the training after the intervention group (Group 1). The intervention consisted of a weekly mhGAP-based training session (totalling 6 weeks), comprising lectures, discussions, role plays and a support session offered by trainers. Data were collected at baseline, following Group 1's training, following Group 2's training and 18 months after training. Descriptive, bivariate and ANOVA analyses were conducted. Overall, 112 PCPs were randomized to either Group 1 (n = 52) or Group 2 (n = 60). The training had a statistically significant short-term impact on mental health knowledge, attitudes and self-efficacy scores but not on self-reported practice. When comparing pre-training results and results 18 months after training, these changes were maintained. PCPs reported a decrease in referral rates to specialized services 18 months after training in comparison to pre-training. The mhGAP-based training might be useful to increase mental health knowledge and self-efficacy, and decrease reported referral rates and negative mental health attitudes among PCPs in Tunisia and other low- and middle-income countries. Future studies should examine relationships among these outcome variables.",2020,"The training had a statistically significant short-term impact on mental health knowledge, attitudes and self-efficacy scores but not on self-reported practice.",['112 PCPs'],"['Mental Health Gap Action Programme (mhGAP) Intervention Guide (IG', 'mhGAP', 'mhGAP-based training session']","['referral rates', 'mental health knowledge, attitudes and self-efficacy scores', 'mental health knowledge and self-efficacy']","[{'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",112.0,0.0308756,"The training had a statistically significant short-term impact on mental health knowledge, attitudes and self-efficacy scores but not on self-reported practice.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spagnolo', 'Affiliation': 'School of Public Health, IRSPUM, Université de Montréal, 7101 Park Avenue, Montréal, Québec H3N 1X9, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Champagne', 'Affiliation': 'School of Public Health, IRSPUM, Université de Montréal, 7101 Park Avenue, Montréal, Québec H3N 1X9, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Leduc', 'Affiliation': 'School of Public Health, IRSPUM, Université de Montréal, 7101 Park Avenue, Montréal, Québec H3N 1X9, Canada.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Rivard', 'Affiliation': 'School of Public Health, IRSPUM, Université de Montréal, 7101 Park Avenue, Montréal, Québec H3N 1X9, Canada.'}, {'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Melki', 'Affiliation': 'Hôpital Razi, Manouba, Tunisia.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Piat', 'Affiliation': 'Douglas Mental Health University Institute, 6875 Boulevard LaSalle, Verdun, QC H4H 1R3, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Laporta', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Avenue des Pins, Montréal, QC H3A 1A1, Canada.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Guesmi', 'Affiliation': 'Centre médico-scolaire et universitaire de Manouba, Manouba, Tunisia.'}, {'ForeName': 'Nesrine', 'Initials': 'N', 'LastName': 'Bram', 'Affiliation': 'Hôpital Razi, Manouba, Tunisia.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Charfi', 'Affiliation': 'Faculté de médecine, Université de Tunis El-Manar, Tunis, Tunisia.'}]",Health policy and planning,['10.1093/heapol/czz138']
3511,31351965,"Efficacy and safety of intra-articular injection of tropomyosin receptor kinase A inhibitor in painful knee osteoarthritis: a randomized, double-blind and placebo-controlled study.","OBJECTIVE


This trial evaluated the efficacy and safety of GZ389988A, a tropomyosin receptor kinase A (TrkA) inhibitor, in subjects with painful knee osteoarthritis (OA).
METHOD


In this single center, double-blind, placebo-controlled and randomized trial, 104 subjects with moderate-to-severe knee OA pain were enrolled to receive a single intra-articular (IA) injection of either GZ389988A or placebo. Efficacy measures were assessed over 12 weeks and included walking pain (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] A1), overall knee pain, WOMAC A, B, C and total score, Patient Global Impression of Change (PGIC), OMERACT-OARSI responder rate and rescue medication use. Adverse events (AEs) were monitored up to 24 weeks.
RESULTS


The primary efficacy endpoint was met with a between-group difference of -7.49 (VAS 0-100) on WOMAC A1 changes over 4 weeks (P < 0.05 favoring GZ389988A). The secondary outcome on WOMAC A1 changes over 12 weeks had a between-group difference of -6.78 (P = 0.064). Among weekly assessments, statistically significant greater improvement in the GZ389988A group was observed in WOMAC A1, overall knee pain and/or WOMAC A at weeks 2-5. Although not statistically significant, improvements over placebo on pain and WOMAC C persisted over 12 weeks. Greater AE incidence was observed in the GZ389988A group including transient and self-limited injection joint inflammatory reactions with a spike of acetaminophen intake within the first week post-injection.
CONCLUSION


IA injection of TrkA inhibitor GZ389988A in knee OA subjects reduced pain with a numerically functional gain and an acceptable safety profile. (ClinicalTrials.gov, NCT02845271).",2019,(VAS 0-100) on WOMAC A1 changes over 4 weeks (P < 0.05 favoring GZ389988A).,"['104 subjects with moderate-to-severe knee OA pain', 'painful knee osteoarthritis', 'subjects with painful knee osteoarthritis (OA']","['intra-articular injection of tropomyosin receptor kinase A inhibitor', 'placebo', 'GZ389988A', 'single intra-articular (IA) injection of either GZ389988A or placebo', 'GZ389988A, a tropomyosin receptor kinase A (TrkA) inhibitor', 'TrkA inhibitor GZ389988A']","['Greater AE incidence', 'WOMAC A1 changes', 'walking pain (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] A1), overall knee pain, WOMAC A, B, C and total score, Patient Global Impression of Change (PGIC), OMERACT-OARSI responder rate and rescue medication use', 'pain and WOMAC C', 'WOMAC A1, overall knee pain', 'Efficacy and safety', 'Adverse events (AEs']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0041197', 'cui_str': 'Tropomyosin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",104.0,0.391738,(VAS 0-100) on WOMAC A1 changes over 4 weeks (P < 0.05 favoring GZ389988A).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Krupka', 'Affiliation': 'Sanofi R&D, 371, Rue du Professeur Joseph Blayac, 34184 Montpellier, France. Electronic address: emmanuel.krupka@sanofi.com.'}, {'ForeName': 'G-L', 'Initials': 'GL', 'LastName': 'Jiang', 'Affiliation': 'Sanofi R&D, 50 Binney Street, Cambridge, MA 02142, USA. Electronic address: LeonJiangMD@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jan', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385 Chilly-Mazarin, France. Electronic address: christelle.jan@sanofi.com.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.05.028']
3512,32104687,Effects of Living High-Training Low and High on Body Composition and Metabolic Risk Markers in Overweight and Obese Females.,"This study examined the effects of 4 weeks of living high-training low and high (LHTLH) under moderate hypoxia on body weight, body composition, and metabolic risk markers of overweight and obese females. Nineteen healthy overweight or obese females participated in this study. Participants were assigned to the normoxic training group (NG) or the LHTLH group (HG). The NG participants lived and trained at sea level. The HG participants stayed for approximately 10 hours in a simulated 2300 m normobaric state of hypoxia for six days a week and trained for 2 hours 3 times a week under the same simulated hypoxia. The interventions lasted for 4 weeks. All groups underwent dietary restriction based on resting metabolic rate. The heart rate of the participants was monitored every ten minutes during exercise to ensure that the intensity was in the aerobic range. Compared with the preintervention values, body weight decreased significantly in both the NG and the HG (-8.81 ± 2.09% and -9.09 ± 1.15%, respectively). The fat mass of the arm, leg, trunk, and whole body showed significant reductions in both the NG and the HG, but no significant interaction effect was observed. The percentage of lean soft tissue mass loss in the total body weight loss tended to be lower in the HG (27.61% versus 15.94%,  P =0.085). Between the NG and the HG, significant interaction effects of serum total cholesterol (-12.66 ± 9.09% versus -0.05 ± 13.36%,) and apolipoprotein A 1  (-13.66 ± 3.61% versus -5.32 ± 11.07%,  P =0.042) were observed. A slight increase in serum high-density lipoprotein cholesterol (HDL-C) was observed in the HG (1.12 ± 12.34%) but a decrease was observed in the NG (-11.36 ± 18.91%). The interaction effect of HDL-C between NG and HG exhibited a significant trend ( P =0.055). No added effects on serum triglycerides (TGs), low-density lipoprotein cholesterol (LDL-C), or APO-B were observed after 4 weeks of LHTLH. In conclusion, 4 weeks of LHTLH combined with dietary restriction could effectively reduce the body weight and body fat mass of overweight and obese females. Compared with training and sleeping under normoxia, no additive benefit of LHTLH on the loss of body weight and body fat mass was exhibited. However, LHTLH may help to relieve the loss of lean soft tissue mass and serum HDL-C.",2020,"The fat mass of the arm, leg, trunk, and whole body showed significant reductions in both the NG and the HG, but no significant interaction effect was observed.","['Overweight and Obese Females', 'Nineteen healthy overweight or obese females', 'overweight and obese females']","['normoxic training group (NG) or the LHTLH group (HG', 'dietary restriction', 'LHTLH combined with dietary restriction', 'living high-training low and high (LHTLH', 'Living High-Training Low and High', 'LHTLH']","['serum total cholesterol', 'body weight, body composition, and metabolic risk markers', 'body weight and body fat mass', 'Body Composition and Metabolic Risk Markers', 'body weight', 'total body weight loss', 'loss of lean soft tissue mass and serum HDL-C', 'serum triglycerides (TGs), low-density lipoprotein cholesterol (LDL-C), or APO-B', 'body weight and body fat mass of overweight and obese females', 'percentage of lean soft tissue mass loss', 'heart rate', 'serum high-density lipoprotein cholesterol (HDL-C']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass (morphologic abnormality)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",19.0,0.0210466,"The fat mass of the arm, leg, trunk, and whole body showed significant reductions in both the NG and the HG, but no significant interaction effect was observed.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Shanghai Research Institute of Sports Science, Shanghai, China.'}, {'ForeName': 'Jianfang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'China Institute of Sport Science, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'China Institute of Sport Science, Beijing, China.'}, {'ForeName': 'Yingli', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'China Institute of Sport Science, Beijing, China.'}, {'ForeName': 'Binghong', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Lianshi', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'China Institute of Sport Science, Beijing, China.'}]",BioMed research international,['10.1155/2020/3279710']
3513,32126750,Continuous infusion versus intermittent bolus injection of propofol during endoscopic retrograde cholangiopancreatography.,"BACKGROUND/AIMS


It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation in endoscopic retrograde cholangiopancreatography (ERCP). We aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of propofol during therapeutic ERCP.
METHODS


In this prospective study, we randomly assigned 232 patients undergoing therapeutic ERCP to either continuous infusion (CI group, n = 113) or intermittent bolus injection (BI group, n = 119) of propofol. The primary outcome was the quality of sedation as assessed by the endoscopist. Other sedation-related parameters included sedation induction time, total dose of propofol, recovery time, involuntary patient movement, and adverse events.
RESULTS


Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both). However, patients in the CI group had a significantly longer sedation induction time (5.28 minutes vs. 4.34 minutes, p < 0.01) and received a higher dose of propofol than patients in the BI group (4.22 mg/kg vs. 2.08 mg/kg, p < 0.01). There was no significant difference in adverse events between the two groups.
CONCLUSION


Continuous infusion of propofol during therapeutic ERCP had the advantage over intermittent bolus injection of maintaining a constant level of sedation without increasing adverse events. However, it was associated with an increased total dose of propofol and prolonged sedation induction time.",2020,"Results


Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both).",['232 patients undergoing'],"['therapeutic ERCP to either continuous infusion (CI group, n = 113) or intermittent bolus injection (BI group, n = 119) of propofol', 'propofol']","['efficacy and safety', 'sedation induction time', 'quality of sedation', 'sedation induction time, total dose of propofol, recovery time, involuntary patient movement, and adverse events', 'adverse events', 'Overall satisfaction with sedation by the endoscopist and monitoring nurse', 'total dose of propofol and prolonged sedation induction time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",232.0,0.0230448,"Results


Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both).","[{'ForeName': 'Jae Gon', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Kyo-Sang', 'Initials': 'KS', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Young Jae', 'Initials': 'YJ', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2018.233']
3514,31912958,Intermittent low dose carbon monoxide inhalation does not influence glucose regulation in overweight adults: a randomized controlled crossover trial.,"NEW FINDINGS


What is the central question of this study? Low dose carbon monoxide (CO) inhalation plays a role in regulating proteins involved in glucose metabolism; does low dose CO improve glucose and insulin responses to an oral glucose tolerance test in overweight adults? What is the main finding and its importance? Five days of intermittent CO inhalation does not alter the glucose or insulin responses to ingestion of a glucose bolus in overweight adults. Low dose CO is utilized in various physiological assessment procedures; these findings allow researchers and clinicians to utilize these procedures without concern of altering glucose metabolism.
ABSTRACT


Low dose carbon monoxide (CO) inhalation upregulates several proteins important for glucose metabolism. Such changes could be clinically significant and may be relevant to those who use CO as a research tool. We hypothesized that low dose CO inhalation would improve glucose and insulin responses to an oral glucose bolus in overweight humans. Eleven young adults (5 men, 6 women; body mass index: 25-35 kg m -2  ) were included in this randomized, placebo-controlled, single-blinded crossover study. Following screening, participants completed two 7-day protocols with a 4-week washout. Twenty-four hours prior to and following five consecutive days of either once daily CO (men: 1.2 ml (kg body mass) -1  ; women: 1.0 ml (kg body mass) -1  ) or placebo (room air) inhalation, participants underwent oral glucose tolerance tests (OGTT). For key outcome variables, there were no significant main effects or interactions across condition or time point (mean ± SD), including fasting glucose (mg dl -1  : pre-placebo: 85.2 ± 10.1; post-placebo: 82.9 ± 10.6; pre-CO: 83.6 ± 7.7; post-CO: 84.0 ± 9.0), 2 h post glucose (mg dl -1  : pre-placebo: 100.9 ± 20.0; post-placebo: 98.7 ± 13.1; pre-CO: 94.2 ± 23.2; post-CO: 94.4 ± 14.9), or the Matsuda index (pre-placebo: 16.1 ± 11.5; post-placebo: 20.3 ± 24.7; pre-CO: 15.6 ± 15.3; post-CO: 17.5 ± 16.8). In conclusion, 5 days of low dose CO administration did not influence glucose and insulin responses to an OGTT in overweight adults. Low dose CO inhalation is utilized in a variety of physiological assessment procedures; these findings allow researchers to utilize these procedures without concern of altering glucose metabolism.",2020,Five days of intermittent CO inhalation does not alter the glucose or insulin responses to ingestion of a glucose bolus in overweight adults.,"['overweight adults', 'overweight humans', 'Eleven young adults (5 men, 6 women; body mass index: 25-35\xa0kg/m 2  ']","['Low dose carbon monoxide (CO) inhalation', 'Intermittent low dose carbon monoxide inhalation', 'CO inhalation', 'placebo: 16.1\xa0±\xa011.5; post-placebo', 'placebo (room air) inhalation, participants underwent oral glucose tolerance tests (OGTT', 'placebo', 'carbon monoxide (CO) inhalation']","['interactions across condition or timepoint (mean ± sd), including fasting glucose', 'glucose or insulin responses', 'glucose and insulin responses']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",11.0,0.259565,Five days of intermittent CO inhalation does not alter the glucose or insulin responses to ingestion of a glucose bolus in overweight adults.,"[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Goodrich', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Frisco', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'S P P', 'Initials': 'SPP', 'LastName': 'Ryan', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Newman', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'S R J', 'Initials': 'SRJ', 'LastName': 'Trikha', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Braun', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bell', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Byrnes', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}]",Experimental physiology,['10.1113/EP088329']
3515,31610995,A Randomized Trial of Alerting to Hypocholesterolemia Results of the Low Indexes of Metabolism Intervention Trial-C (LIMIT-C).,"OBJECTIVES


The benefit of alerting clinical staff to drug-induced hypocholesterolemia in patients aged 75 years and older remains uncertain.
DESIGN, SETTING, AND PARTICIPANTS


The study included 1791 patients with serum cholesterol <160 mg/dL and on cholesterol-lowering drugs who were assigned to have an e-mail alert sent to their physician, and 1804 patients who were assigned to receive usual clinical care (control group). The primary outcome of the trial was annual death rate. Secondary outcomes included cholesterol-lowering drug dose reduction and emergency department (ED) visits.
RESULTS


At 1 year, 58 patients (3.2%) in the intervention group and 61 (3.4%) in the control group had died [relative risk 0.94, 95% confidence interval (CI) 0.66-1.34; P = .74]. Quarter-averaged cholesterol-lowering drug defined daily doses were reduced by -13.5 ± 47.0 (-17% ± 60%) in the intervention group and by -5.1 ± 42.2 (-6%±54%) in the control group (difference -8.5 ± 1.5, 95% CI -5.5 to -11.4; P < .0001). Annual ED visit rates per 1000 patients were 291 in the intervention group and 336 in the control group (45 fewer visits per 1000 patients in the intervention group, 95% CI -1 to -89; P = .04).
CONCLUSIONS AND IMPLICATIONS


In this trial, alerting clinical staff to hypocholesterolemia in patients aged 75 years and older being treated with cholesterol-lowering drugs was associated with mildly reduced cholesterol-lowering drugs doses and marginally reduced ED visit rates. This e-mail alert intervention was not associated with a significant difference in 1-year survival rate compared with usual clinical care.",2020,This e-mail alert intervention was not associated with a significant difference in 1-year survival rate compared with usual clinical care.,"['patients aged 75\xa0years and older remains uncertain', '1791 patients with serum cholesterol <160\xa0mg/dL and on cholesterol-lowering drugs who were assigned to have an e-mail alert sent to their physician, and 1804 patients who were assigned to receive', 'patients aged 75\xa0years and older being treated with cholesterol-lowering drugs was associated with mildly reduced cholesterol-lowering drugs doses and marginally reduced ED visit rates']",['usual clinical care (control group'],"['annual death rate', 'Quarter-averaged cholesterol-lowering drug defined daily doses', 'cholesterol-lowering drug dose reduction and emergency department (ED) visits', 'Annual ED visit rates', '1-year survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0678766', 'cui_str': 'Drug dose'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0678766', 'cui_str': 'Drug dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",1791.0,0.213005,This e-mail alert intervention was not associated with a significant difference in 1-year survival rate compared with usual clinical care.,"[{'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Tsabar', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel; The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel; International Group for Reducing Inappropriate Medication Use & Polypharmacy (IGRIMUP), Bat Yam, Israel. Electronic address: tsabar.nir@gmail.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Press', 'Affiliation': 'Department of Family Medicine, Sial Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Unit for Community Geriatrics, Division of Health in the Community, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Geriatrics, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Rotman', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel.'}, {'ForeName': 'Bracha', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Grossman', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel; The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vainshtein-Tal', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Eilat-Tsanani', 'Affiliation': 'Clalit Health Services (CHS), Northern District, Israel; The Azrieli Faculty of Medicine in Galilee, Bar-Ilan University, Safed, Israel.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.08.018']
3516,32095884,Comparison of Mill Suss™-guided radial artery catheterization with the long-axis in-plane ultrasound-guided method under general anesthesia: a randomized controlled trial.,"Continuous arterial blood pressure measurement is an effective perioperative monitoring method in patients with high-risk comorbidities. Recently, ultrasound guidance has been reported to facilitate radial artery catheterization. A new device, Mill Suss™, has also been developed for visualization of the radial artery and superficial veins using near-infrared laser light. In this study, we hypothesized that the Mill Suss-guided method might reduce the time and the number of attempts required for radial artery catheterization under general anesthesia, as compared to the long-axis in-plane ultrasound-guided method. Seventy-two adult patients aged 20-80 years, ASA physical status I or II, were randomly assigned to the Mill Suss-guided group (Group M: n = 36) or ultrasound-guided group (Group U: n = 36). Primary outcomes were the time required for successful radial artery catheterization and the number of cannulation attempts. There were no significant differences in the characteristics of patients between the two groups. The time required for successful radial artery catheterization was significantly shorter in Group M than in Group U. The number of attempts for successful cannulation was not statistically significantly different between the two groups. However, the results might be different among anesthesiologists well experienced in the ultrasound-guided method.",2020,The number of attempts for successful cannulation was not statistically significantly different between the two groups.,"['Seventy-two adult patients aged 20-80\xa0years, ASA physical status I or II', 'patients with high-risk comorbidities', 'plane ultrasound-guided method under general anesthesia']","['Mill Suss-guided group (Group M: n\u2009=\u200936) or ultrasound-guided group', 'Continuous arterial blood pressure measurement', 'Mill Suss™-guided radial artery catheterization']","['time required for successful radial artery catheterization', 'number of attempts for successful cannulation', 'time required for successful radial artery catheterization and the number of cannulation attempts']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0599997', 'cui_str': 'Mill (environment)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162857', 'cui_str': 'Radial Artery'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]",72.0,0.0601745,The number of attempts for successful cannulation was not statistically significantly different between the two groups.,"[{'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Osuda', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. elysium102@hotmail.com.'}, {'ForeName': 'Mitsutaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Ihara', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anesthesia, Oji General Hospital, Tomakomai, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02749-z']
3517,32112507,Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial.,"Digital cognitive behavioural therapy (dCBT) is an effective treatment for chronic insomnia and also improves well-being and quality of life (QoL). We assessed whether these benefits are sustained and if the effects of dCBT extend to the use of sleep medication and healthcare. In total 1,711 adults (48.0 ± 13.8 years, 77.6% female) with complaints of chronic insomnia participated in a previously published randomized controlled trial (ISRCTN 60530898) comparing dCBT (n = 853) with sleep hygiene education (SHE, n = 858). At weeks 0, 4, 8, 24, 36 and 48, we assessed functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale); psychological well-being (Warwick-Edinburgh Mental Well-being Scale) and sleep-related QoL (Glasgow Sleep Impact Index), prescribed and non-prescribed sleep medication use, and healthcare utilization. At week 25, those who received SHE at baseline were offered dCBT. dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p < .001), psychological well-being (difference: 4.34, 95% CI: 3.70; 4.98, Cohen's d: 0.55, p < .001) and sleep-related QoL (difference: -44.61, 95%CI: -47.17; -42.05, Cohen's d: -1.44, p < .001) at week 48 compared to baseline. At week 24 dCBT, compared to SHE, also reduced use of prescription and non-prescription sleep medication up to week 24 (adjusted rate ratio [RR]: 0.64, 95% CI: 0.42; 0.97, p = .037 and adjusted RR: 0.52, 95% CI: 0.37; 0.74, p < .0001, respectively), but not healthcare utilization. Uncontrolled follow-up suggests that these effects were sustained for non-prescribed sleep medication (RR: 0.52, 95% CI: 0.40; 0.67, p < .001). In conclusion, this study suggests that dCBT results in sustained benefits to insomnia and its daytime outcomes.",2020,"dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p < .001), psychological well-being (difference: 4.34, 95% CI: 3.70; 4.98, Cohen's d: 0.55, p < .001) and sleep-related QoL (difference: -44.61, 95%CI: -47.17; -42.05, Cohen's d: -1.44, p < .001) at week 48 compared to baseline.","['n\xa0=\xa0853) with sleep hygiene education (SHE, n\xa0=\xa0858', 'In total 1,711 adults (48.0\xa0±\xa013.8\xa0years, 77.6% female) with complaints of chronic insomnia', 'insomnia']","['digital cognitive behavioural therapy', 'dCBT', 'Digital cognitive behavioural therapy (dCBT']","['Global Health Scale); psychological well-being (Warwick-Edinburgh Mental Well-being Scale) and sleep-related QoL (Glasgow Sleep Impact Index), prescribed and non-prescribed sleep medication use, and healthcare utilization', 'well-being and quality of life (QoL', 'sleep-related QoL', 'reduced use of prescription and non-prescription sleep medication', 'functional health (Patient-Reported Outcomes Measurement Information System', 'functional health']","[{'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4273514', 'cui_str': 'Warwick Edinburgh Mental Well Being Scale'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}]",1711.0,0.354784,"dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p < .001), psychological well-being (difference: 4.34, 95% CI: 3.70; 4.98, Cohen's d: 0.55, p < .001) and sleep-related QoL (difference: -44.61, 95%CI: -47.17; -42.05, Cohen's d: -1.44, p < .001) at week 48 compared to baseline.","[{'ForeName': 'Annemarie I', 'Initials': 'AI', 'LastName': 'Luik', 'Affiliation': 'Department of Epidemiology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Marsden', 'Affiliation': 'Centre for Biostatistics, School of Health Sciences, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Biostatistics and Health Informatics Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}]",Journal of sleep research,['10.1111/jsr.13018']
3518,32100358,Effect of Drinking Oxygenated Water Assessed by in vivo MRI Relaxometry.,"GRANT SUPPORT


This project was funded by the Research Council of Norway.
BACKGROUND


Oxygen uptake through the gastrointestinal tract after oral administration of oxygenated water in humans is not well studied and is debated in the literature. Due to the paramagnetic properties of oxygen and deoxyhemoglobin, MRI as a technique might be able to detect changes in relaxometry values caused by increased oxygen levels in the blood.
PURPOSE


To assess whether oxygen dissolved in water is absorbed from the gastrointestinal tract and transported into the bloodstream after oral administration.
STUDY TYPE


A randomized, double-blinded, placebo-controlled crossover trial.
POPULATION/SUBJECTS


Thirty healthy male volunteers age 20-35.
FIELD STRENGTH/SEQUENCE


3T/Modified Look-Locker inversion recovery (MOLLI) T 1  -mapping and multi fast field echo (mFFE) T 2  *-mapping.
ASSESSMENT


Each volunteer was scanned in two separate sessions. T 1  and T 2  * maps were acquired repeatedly covering the hepatic portal vein (HPV) and vena cava inferior (VCI, control vein) before and after intake of oxygenated or control water. Assessments were done by placing a region of interest in the HPV and VCI.
STATISTICAL TEST


A mixed linear model was performed to the compare control vs. oxygen group.
RESULTS


Drinking caused a mean 1.6% 95% CI (1.1-2.0% P < 0.001) increase in T 1  of HPV blood and water oxygenation attributed another 0.70% 95% confidence interval (CI) (0.07-1.3% P = 0.028) increase. Oxygenation did not change T 1  in VCI blood. Mean T 2  * increased 9.6% 95% CI (1.7-17.5% P = 0.017) after ingestion of oxygenated water and 1.2% 95% CI (-4.3-6.8% P = 0.661) after ingestion of control water. The corresponding changes in VCI blood were not significant.
DATA CONCLUSION


Ingestion of water caused changes in T 1  and T 2  * of HPV blood compatible with dilution due to water absorption. The effects were enhanced by oxygen. Assessment of oxygen enrichment of HPV blood was not possible due to the dilution effect.
LEVEL OF EVIDENCE


2 TECHNICAL EFFICACY STAGE: 2 J. Magn. Reson. Imaging 2020;52:720-728.",2020,Mean T 2  * increased 9.6% 95% CI (1.7-17.5% P = 0.017) after ingestion of oxygenated water and 1.2% 95% CI (-4.3-6.8% P = 0.661) after ingestion of control water.,['Thirty healthy male volunteers age 20-35'],['placebo'],"['hepatic portal vein (HPV) and vena cava inferior (VCI, control vein', 'VCI blood', 'Drinking Oxygenated Water Assessed by in vivo MRI Relaxometry', 'HPV blood and water oxygenation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0042460', 'cui_str': 'Venae Cavae'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0005768'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",30.0,0.11569,Mean T 2  * increased 9.6% 95% CI (1.7-17.5% P = 0.017) after ingestion of oxygenated water and 1.2% 95% CI (-4.3-6.8% P = 0.661) after ingestion of control water.,"[{'ForeName': 'Svein Are Sirirud', 'Initials': 'SAS', 'LastName': 'Vatnehol', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Per Kristian', 'Initials': 'PK', 'LastName': 'Hol', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Bjørnerud', 'Affiliation': 'Department of Physics, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Amiry-Moghaddam', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Haglerød', 'Affiliation': 'Oxy Solutions AS, Oslo, Norway.'}, {'ForeName': 'Tryggve Holck', 'Initials': 'TH', 'LastName': 'Storås', 'Affiliation': 'Department of Diagnostic Physics, Oslo University Hospital, Oslo, Norway.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27104']
3519,32106179,Prosthesis in Anterior Cervical Herniated Disc Approach Does Not Prevent Radiologic Adjacent Segment Degeneration.,"STUDY DESIGN


Retrospective analysis using data from RCTs OBJECTIVE.: This study aimed to report on the incidence of radiological adjacent segment degeneration (ASD) in patients with cervical radiculopathy due to a herniated disc that were randomized to receive cervical arthroplasty or arthrodesis.
SUMMARY OF BACKGROUND DATA


Cervical disc prostheses were introduced to prevent ASD in the post-surgical follow-up. However, it is still a controversial issue.
METHODS


253 Patients were included in two randomized, double-blinded trials comparing anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD) for one-level disc herniation. Neutral lateral radiographs were obtained preoperatively, at 1- and 2-year follow-up after surgery. Radiological ASD was evaluated on X-ray and defined by a decrease in disc height and the presence of anterior osteophyte formation on both the superior and the inferior level in relation to the target level.
RESULTS


Radiological ASD was present in 34% of patients at baseline and increased to 59% at two-year follow-up in the arthrodesis groups (ACD and ACDF combined), and to 56% in the arthroplasty group. Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
CONCLUSIONS


Radiological ASD occurs in a similar manner in patients that were subjected to arthrodesis in cervical radiculopathy and in patients that received arthroplasty to maintain motion. Current data tend to indicate that the advantage of cervical prosthesis in preventing radiological ASD is absent.
LEVEL OF EVIDENCE


2.",2020,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","['253 Patients', 'patients with cervical radiculopathy due to a herniated disc']","['anterior cervical discectomy with arthroplasty (ACDA), with intervertebral cage (ACDF), or without intervertebral cage (ACD', 'cervical arthroplasty or arthrodesis']","['Progression of radiological ASD', 'disc height', 'Radiological ASD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0021818', 'cui_str': 'Disc, Herniated'}]","[{'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral (qualifier value)'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}]",253.0,0.137081,"Progression of radiological ASD was present in 29% of patients in the arthrodesis group and in 31% of patients in the arthroplasty group for 2-year follow-up.
","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Donk', 'Affiliation': 'Department of Orthopaedic Surgery, Via Sana Clinics, Mill, The Netherlands.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Arts', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Centre, PO Box 432, 2512 VA The Hague, The Netherlands.'}, {'ForeName': 'Ronald H M A', 'Initials': 'RHMA', 'LastName': 'Bartels', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Carmen L A', 'Initials': 'CLA', 'LastName': 'Vleggeert-Lankamp', 'Affiliation': 'Department of Neurosurgery, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands.'}]",Spine,['10.1097/BRS.0000000000003453']
3520,32101269,Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial.,"Importance


The application of indocyanine green (ICG) imaging in laparoscopic radical gastrectomy is in the preliminary stages of clinical practice, and its safety and efficacy remain controversial.
Objective


To investigate the safety and efficacy of ICG near-infrared tracer-guided imaging during laparoscopic D2 lymphadenectomy in patients with gastric cancer.
Design, Setting, and Participants


Patients with potentially resectable gastric adenocarcinoma (clinical tumor stage cT1-cT4a, N0/+, M0) were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital between November 2018 and July 2019. Patients were randomly assigned to the ICG group or the non-ICG group. The number of retrieved lymph nodes, rate of lymph node noncompliance, and postoperative recovery data were compared between the groups in a modified intention-to-treat analysis. Statistical analysis was performed from August to September 2019.
Interventions


The ICG group underwent laparoscopic gastrectomy using near-infrared imaging after receiving an endoscopic peritumoral injection of ICG to the submucosa 1 day before surgery.
Main Outcomes and Measures


Total number of retrieved lymph nodes.
Results


Of 266 participants randomized, 133 underwent ICG tracer-guided laparoscopic gastrectomy, and 133 underwent conventional laparoscopic gastrectomy. After postsurgical exclusions, 258 patients were included in the modified intention-to-treat analysis, which comprised 129 patients (86 men and 43 women; mean [SD] age, 57.8 [10.7] years) in the ICG group and 129 patients (87 men and 42 women; mean [SD] age, 60.1 [9.1] years) in the non-ICG group. The mean number of lymph nodes retrieved in the ICG group was significantly more than the mean number retrieved in the non-ICG group (mean [SD], 50.5 [15.9] lymph nodes vs 42.0 [10.3] lymph nodes, respectively; P < .001). Significantly more perigastric and extraperigastric lymph nodes were retrieved in the ICG group than in the non-ICG group. In addition, the mean total number of lymph nodes retrieved in the ICG group within the scope of D2 lymphadenectomy was also significantly greater than the mean number retrieved in the non-ICG group (mean [SD], 49.6 [15.0] lymph nodes vs 41.7 [10.2] lymph nodes, respectively; P < .001). The lymph node noncompliance rate of the ICG group (41 of 129 patients [31.8%]) was lower than that of the non-ICG group (74 of 129 patients [57.4%]; P < .001). The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
Conclusions and Relevance


Indocyanine green can noticeably improve the number of lymph node dissections and reduce lymph node noncompliance without increased complications in patients undergoing D2 lymphadenectomy. Indocyanine green fluorescence imaging can be performed for routine lymphatic mapping during laparoscopic gastrectomy, especially total gastrectomy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03050879.",2020,"The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
","['Patients With Gastric Cancer', 'patients undergoing D2 lymphadenectomy', 'Participants\n\n\nPatients with potentially resectable gastric adenocarcinoma (clinical tumor stage cT1-cT4a, N0/+, M0) were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital between November 2018 and July 2019', '266 participants randomized, 133 underwent', 'patients with gastric cancer', '258 patients were included in the modified intention-to-treat analysis, which comprised 129 patients (86 men and 43 women; mean [SD] age, 57.8 [10.7] years) in the ICG group and 129 patients (87 men and 42 women; mean [SD] age, 60.1']","['ICG', 'ICG tracer-guided laparoscopic gastrectomy', 'ICG near-infrared tracer-guided imaging during laparoscopic D2 lymphadenectomy', 'indocyanine green (ICG) imaging', 'laparoscopic gastrectomy', 'Indocyanine Green Tracer-Guided Lymph Node Dissection', 'Indocyanine', 'Laparoscopic Radical Gastrectomy', 'conventional laparoscopic gastrectomy', 'ICG group or the non-ICG']","['severity of complications', 'mean total number of lymph nodes', 'Measures\n\n\nTotal number of retrieved lymph nodes', 'postoperative recovery process', 'mean number of lymph nodes', 'number of retrieved lymph nodes, rate of lymph node noncompliance, and postoperative recovery data', 'perigastric and extraperigastric lymph nodes', 'lymph node noncompliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",258.0,0.0898331,"The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
","[{'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.6033']
3521,32115998,Exposure to body diversity images as a buffer against the thin-ideal: An experimental study.,"There has recently been a call for the use of more diverse images by the media to promote body satisfaction. This experimental study evaluated the impact of body diversity images and whether these could act as a buffer against thin-ideal norms. Female participants (n = 106, aged 16-30 years) completed measures of body compassion, body and face satisfaction before and after random allocation to images reflecting one of three interventions: control, body diversity and thin-ideal. Attitudes towards thin-ideal images were also assessed. The results showed significant differences between groups for overall body compassion, the body compassion subtype of body kindness, body satisfaction and face satisfaction with those viewing the body diversity images reporting higher scores after exposure compared to the other two groups. Those in the body diversity group also displayed more negative attitudes towards thin-ideal images compared to controls. No between groups differences were found for body compassion subtypes relating to common humanity, motivated action and body criticism or positive attitudes to the thin-ideal images. In sum, exposure to body diversity images had a positive impact on body kindness and overall body compassion and body satisfaction providing experimental support for the use of diversity images as a buffer against thin-deals.",2020,"No between groups differences were found for body compassion subtypes relating to common humanity, motivated action and body criticism or positive attitudes to the thin-ideal images.","['Female participants (n\xa0', '106, aged 16-30\xa0years']",[],"['overall body compassion, the body compassion subtype of body kindness, body satisfaction and face satisfaction', 'body kindness and overall body compassion and body satisfaction', 'body compassion subtypes relating to common humanity, motivated action and body criticism or positive attitudes', 'negative attitudes', 'body compassion, body and face satisfaction']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0237428', 'cui_str': 'Optimism'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude (finding)'}]",106.0,0.02106,"No between groups differences were found for body compassion subtypes relating to common humanity, motivated action and body criticism or positive attitudes to the thin-ideal images.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Ogden', 'Affiliation': 'School of Psychology, University of Surrey , Guildford, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Gosling', 'Affiliation': 'School of Psychology, University of Surrey , Guildford, UK.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Hazelwood', 'Affiliation': 'School of Psychology, University of Surrey , Guildford, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Atkins', 'Affiliation': 'School of Psychology, University of Surrey , Guildford, UK.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1734219']
3522,32105198,Virtual Microscopy Is More Effective Than Conventional Microscopy for Teaching Cytology to Veterinary Students: A Randomized Controlled Trial.,"Virtual microscopy (VM) using scanned slides and imaging software is increasingly used in medical curricula alongside instruction in conventional microscopy (CM). Limited reports suggest that VM is useful in the veterinary education setting, and generally well-received by students. Whether students can apply knowledge gained through VM to practical use is unknown. Our objective was to determine whether instruction using VM, compared to CM, is a successful method of training veterinary students for the application of cytology in practice (i.e., using light microscopes). Seventy-one veterinary students from Colorado State University who attended a voluntary 3-hour cytology workshop were randomized to receive the same instruction with either VM ( n  = 35) or CM ( n  = 36). We compared these students to a control group ( n  = 22) of students who did not attend a workshop. All students took a post-workshop assessment involving the interpretation of four cases on glass slides with CM, designed to simulate the use of cytology in general practice. Students also took an 18-question survey related to the effectiveness of the workshop, providing their opinions on cytology instruction in the curriculum and their learning preference (VM or CM). The mean assessment score of the VM group (14.18 points) was significantly higher than the control group (11.33 points,  p  = .003), whereas the mean of the CM group (12.77 points) was not statistically significantly different from controls ( p  = .170). Not only is VM an effective method of teaching cytology to veterinary students that can be translated to a real-world case scenario, but it outperformed CM instruction in this study.",2020,"The mean assessment score of the VM group (14.18 points) was significantly higher than the control group (11.33 points,  ","['Seventy-one veterinary students from Colorado State University who attended a voluntary 3-hour cytology workshop', 'students to a control group ( n  = 22) of students who did not attend a workshop', 'Teaching Cytology to Veterinary Students']","['Virtual microscopy (VM) using scanned slides and imaging software', 'same instruction with either VM ( n  = 35) or CM']",['mean assessment score'],"[{'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559294', 'cui_str': 'Not attended'}]","[{'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0441633'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",71.0,0.0366819,"The mean assessment score of the VM group (14.18 points) was significantly higher than the control group (11.33 points,  ","[{'ForeName': 'Samantha J M', 'Initials': 'SJM', 'LastName': 'Evans', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'A Russell', 'Initials': 'AR', 'LastName': 'Moore', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Olver', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Avery', 'Affiliation': 'Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'West', 'Affiliation': 'Director of the Academy for Teaching and Learning, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.'}]",Journal of veterinary medical education,['10.3138/jvme.0318-029r1']
3523,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3524,31823902,"Comparison of efficacy of platelet-rich plasma therapy with or without topical 5% minoxidil in male-type baldness: A randomized, double-blind placebo control trial.","Background


Male-type baldness is a common chronic hair loss disorder among males. Male type baldness is characterized by stepwise miniaturization of the hair follicle, due to alteration in the hair cycle dynamics, leading to transformation of the terminal hair follicle into a vellus one. Platelet-rich plasma (PRP) seems to be a new technique which may improve hair regrowth. We planned a randomized, double-blinded placebo control trial to see the efficacy of PRP with and without topical minoxidil and to compare with placebo and standard treatment.
Materials and Methods


The study design was a randomized, double-blind placebo control trial. The sample size was calculated, and randomization was done. Patients with male type baldness were allocated into four groups; first group topical minoxidil only, the second group PRP with minoxidil, the third group normal saline (NS), and fourth group PRP only. Interventions were done monthly for 3 months and patients were followed up for the next 2 months. Effects of interventions were assessed by hair density, patient self-assessment, and clinical photography.
Results


A total of 80 patients were included. The maximum improvement was found in PRP with minoxidil group. Increase in hair density (in descending order) was PRP with minoxidil group, PRP-alone group, minoxidil-alone group, while a decrease in hair density was found in NS group, after 5 months. The maximum patient satisfaction was found in PRP with minoxidil group followed by (in descending order), PRP-alone group, minoxidil-alone group, and NS group.
Limitation


Long-term follow up of patients was not done. Hair counts and hair thickness estimation were not estimated.
Conclusion


In our study, we found PRP with topical minoxidil is more effective than PRP alone and topical minoxidil alone.",2020,"Increase in hair density (in descending order) was PRP with minoxidil group, PRP-alone group, minoxidil-alone group, while a decrease in hair density was found in NS group, after 5 months.","['Male type baldness', 'A total of 80 patients were included', 'male-type baldness', 'Patients with male type baldness']","['placebo', 'placebo and standard treatment', 'PRP with and without topical minoxidil', 'minoxidil, the third group normal saline (NS), and fourth group PRP only', 'topical minoxidil', 'Platelet-rich plasma (PRP', 'minoxidil', 'platelet-rich plasma therapy with or without topical 5% minoxidil']","['maximum patient satisfaction', 'Hair counts and hair thickness estimation', 'hair density, patient self-assessment, and clinical photography', 'hair density']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0431056', 'cui_str': 'Photography of patient'}]",80.0,0.287586,"Increase in hair density (in descending order) was PRP with minoxidil group, PRP-alone group, minoxidil-alone group, while a decrease in hair density was found in NS group, after 5 months.","[{'ForeName': 'Satyendra Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}, {'ForeName': 'Tulika', 'Initials': 'T', 'LastName': 'Rai', 'Affiliation': 'Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.'}]","Indian journal of dermatology, venereology and leprology",['10.4103/ijdvl.IJDVL_589_18']
3525,32109313,The efficacy of ketamine for postoperative pain control in adolescent patients undergoing spinal fusion surgery for idiopathic scoliosis.,"The use of ketamine in conjunction with morphine to reduce postoperative pain has been explored in several different surgery subtypes with conflicting results. Ketamine has shown promise to have both opioid sparing and analgesic effects in the postoperative setting. This study aimed to elucidate ketamine's ability to reduce morphine equivalent consumption and improve patient satisfaction after spinal fusion surgery for the correction of idiopathic scoliosis. This surgery is known to be associated with significant postoperative pain which impedes the ability to improve patient satisfaction, and may complicate the recovery timeline. Currently, the standard therapeutic regimen consists of patient-controlled analgesia morphine and the use of other opioids such as hydromorphone. A prospective, randomized double-blinded, placebo-controlled trial was performed to compare the standard morphine equivalent therapy alone against a standard therapy in conjunction with ketamine. Fifty adolescent patients were enrolled and randomized. Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045). The application of ketamine as an analgesic in conjunction with the current standard of morphine equivalent therapy may serve as a superior pain control regimen for spinal surgeries in young population. This regimen enhancement may be generalizable to other surgery subtypes within similar populations. LEVEL OF EVIDENCE: Level I.",2020,"Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045).","['Fifty adolescent patients', 'spinal surgeries in young population', 'idiopathic scoliosis', 'adolescent patients undergoing spinal fusion surgery for idiopathic scoliosis']","['Ketamine', 'placebo', 'ketamine', 'hydromorphone', 'morphine']","['postoperative morphine equivalent consumption', 'nausea and vomiting', 'patient satisfaction', 'adjusted postoperative pain scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}, {'cui': 'C0919636', 'cui_str': 'Operative spinal fusion'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",50.0,0.218573,"Results yielded a significant reduction in postoperative morphine equivalent consumption (p = 0.042), adjusted postoperative pain scores (p < 0.001), and incidence of nausea and vomiting (p = 0.045).","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Ricciardelli', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Noah M', 'Initials': 'NM', 'LastName': 'Walters', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Maxwill', 'Initials': 'M', 'LastName': 'Pomerantz', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Metcalfe', 'Affiliation': 'Department of Anesthesiology, University of Michigan Hospitals and Health Centers, Ann Arbor, USA.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Afroze', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ehlers', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Leduc', 'Affiliation': 'Department of Anesthesiology, GHS Greenville Memorial Hospital, Greenville, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Feustel', 'Affiliation': 'Albany Medical College, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Silverman', 'Affiliation': 'Department of Anesthesiology, Albany Medical Center, Albany, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Carl', 'Affiliation': 'Department of Orthopedic Surgery, Albany Medical Center, Albany, USA. alcsar308@gmail.com.'}]",Spine deformity,['10.1007/s43390-020-00073-w']
3526,31397179,A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in  in vitro  fertilization (Lotus II): results from the Chinese mainland subpopulation.,"Lotus II, a randomized, open-label, multicenter, international study compared the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) gel for luteal support in IVF. A prespecified subgroup analysis was performed on 239 Chinese mainland subjects from the overall study population ( n  = 1034), who were randomized to oral dydrogesterone 30 mg or 8% MVP gel 90 mg daily from the day of oocyte retrieval until 12 weeks of gestation. The aim was to demonstrate non-inferiority of oral dydrogesterone to MVP gel, assessed by the presence of a fetal heartbeat at 12 weeks of gestation. In the Chinese mainland subpopulation, there was a numerical difference of 9.4% in favor of oral dydrogesterone, with ongoing pregnancy rates at 12 weeks of gestation of 61.4% and 51.9% in the oral dydrogesterone and MVP gel groups, respectively (adjusted difference, 9.4%; 95% CI: -3.4 to 22.1); in the overall population, these were 38.7% and 35%, respectively (adjusted difference, 3.7%; 95% CI: -2.3 to 9.7). In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel. With convenient oral administration, dydrogesterone has potential to transform luteal support treatment.",2020,"In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel.","['luteal support in IVF', '239 Chinese mainland subjects from the overall study population ( n \u2009=\u20091034', 'luteal phase support in  in vitro  fertilization (Lotus II']","['oral dydrogesterone', 'intravaginal progesterone gel', 'micronized vaginal progesterone (MVP) gel', 'dydrogesterone', 'oral dydrogesterone 30\u2009mg or 8% MVP gel']","['ongoing pregnancy rates', 'efficacy and safety']","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0330839', 'cui_str': 'Loteae'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1034.0,0.169489,"In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel.","[{'ForeName': 'Dong-Zi', 'Initials': 'DZ', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Griesinger', 'Affiliation': 'Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Reproductive Medicine, Clinical Center of Reproductive Medicine, First Affiliated Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'Reproductive & Genetic Hospital of Citic-Xiangya, Changsha, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Reproductive Medicine Research Center, Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Hanwang', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Yingpu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Center for Reproductive Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Kahler', 'Affiliation': 'Abbott Laboratories GmbH, Hannover, Germany.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pexman-Fieth', 'Affiliation': 'Abbott GmbH & Co. KG, Wiesbaden, Germany.'}, {'ForeName': 'Jan I', 'Initials': 'JI', 'LastName': 'Olofsson', 'Affiliation': 'Abbott Products Operations AG, Allschwil, Switzerland.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Center for Reproductive Medicine, University Hospital of the Brussels Free University, Brussels, Belgium.'}, {'ForeName': 'Zi-Jiang', 'Initials': 'ZJ', 'LastName': 'Chen', 'Affiliation': 'Center for Reproductive Medicine, Shandong University, Jinan, China.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2019.1645110']
3527,32054899,"Effect of Scalp Nerve Block with Ropivacaine on Postoperative Pain in Patients Undergoing Craniotomy: A Randomized, Double Blinded Study.","Scalp nerve block with ropivacaine has been shown to provide perioperative analgesia. However, the best concentration of ropivacaine is still unknown for optimal analgesic effects. We performed a prospective study to evaluate the effects of scalp nerve block with varied concentration of ropivacaine on postoperative pain and intraoperative hemodynamic variables in patients undergoing craniotomy under general anesthesia. Eighty-five patients were randomly assigned to receive scalp block with either 0.2% ropivacaine, 0.33% ropivacaine, 0.5% ropivacaine, or normal saline. Intraoperative hemodynamics and post-operative pain scores at 2, 4, 6, 24 hours postoperatively were recorded. We found that scalp blockage with 0.2% and 0.33% ropivacaine provided adequate postoperative pain relief up to 2 h, while administration of 0.5% ropivacaine had a longer duration of action (up to 4 hour after craniotomy). Scalp nerve block with varied concentration of ropivacaine blunted the increase of mean arterial pressure in response to noxious stimuli during incision, drilling, and sawing skull bone. 0.2% and 0.5% ropivacaine decreased heart rate response to incision and drilling. We concluded that scalp block using 0.5% ropivacaine obtain preferable postoperative analgesia compared to lower concentrations. And scalp block with ropivacaine also reduced hemodynamic fluctuations in craniotomy operations.",2020,"Scalp nerve block with varied concentration of ropivacaine blunted the increase of mean arterial pressure in response to noxious stimuli during incision, drilling, and sawing skull bone.","['patients undergoing craniotomy under general anesthesia', 'Patients Undergoing Craniotomy', 'Eighty-five patients', 'craniotomy operations']","['ropivacaine', 'scalp block with either 0.2% ropivacaine, 0.33% ropivacaine, 0.5% ropivacaine, or normal saline', 'Scalp Nerve Block with Ropivacaine']","['mean arterial pressure', 'longer duration of action', 'heart rate response', 'Intraoperative hemodynamics and post-operative pain scores', 'scalp blockage', 'postoperative analgesia', 'postoperative pain and intraoperative hemodynamic variables', 'hemodynamic fluctuations', 'Postoperative Pain', 'adequate postoperative pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4517449', 'cui_str': 'Zero point three three'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C1997337', 'cui_str': 'Speed of heart rate response'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",85.0,0.161954,"Scalp nerve block with varied concentration of ropivacaine blunted the increase of mean arterial pressure in response to noxious stimuli during incision, drilling, and sawing skull bone.","[{'ForeName': 'Yaoxin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China.'}, {'ForeName': 'Mengchan', 'Initials': 'M', 'LastName': 'Ou', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China.'}, {'ForeName': 'Lingcan', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China.'}, {'ForeName': 'Yajiao', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, P.R. China. 739501155@qq.com.'}]",Scientific reports,['10.1038/s41598-020-59370-z']
3528,31720933,Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin.,"BACKGROUND


This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.
METHODS


In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m 2 ) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.
RESULTS


Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.
CONCLUSIONS


Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.",2020,"Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017).","['mucinous appendiceal cancer patients undergoing CRS/HIPEC', 'Mucinous Appendiceal Cancer', '121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS', 'subjects with mucinous appendiceal neoplasms who underwent']","['mitomycin, HIPEC perfusion with oxaliplatin', 'mitomycin with oxaliplatin', 'Oxaliplatin and Mitomycin', 'cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC', 'mitomycin', 'Cytoreductive Surgery/HIPEC', 'HIPEC', 'Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire', 'oxaliplatin']","['FWB', 'Baseline physical well-being (PWB', 'PWB', 'overall survival', 'physical and functional outcomes', 'TOI', 'Health-Related Quality of Life']","[{'cui': 'C0496779', 'cui_str': 'Appendiceal Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C4087504', 'cui_str': 'Peritoneal dissemination'}, {'cui': 'C0003614', 'cui_str': 'Appendiceal Neoplasms'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.159859,"Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017).","[{'ForeName': 'Omeed', 'Initials': 'O', 'LastName': 'Moaven', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Konstantinos I', 'Initials': 'KI', 'LastName': 'Votanopoulos', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mansfield', 'Affiliation': 'Department of Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bartlett', 'Affiliation': 'Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McQuellon', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stewart', 'Affiliation': 'Department of Surgery, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Levine', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA. elevine@wakehealth.edu.'}]",Annals of surgical oncology,['10.1245/s10434-019-08064-6']
3529,32089359,Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,"BACKGROUND


Very long-term mortality in men with early prostate cancer treated with surgery versus observation is uncertain.
OBJECTIVE


To determine long-term effects of surgery versus observation on all-cause mortality for men with early prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS


This study evaluated long-term follow-up of a randomized trial conducted at the US Department of Veterans Affairs and National Cancer Institute sites. The participants were men (n=731) ≤75yr of age with localized prostate cancer, prostate-specific antigen (PSA) <50ng/ml, life expectancy ≥10yr, and medically fit for surgery.
INTERVENTION


Radical prostatectomy versus observation.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


All-cause mortality was assessed in the entire cohort and patient and tumor subgroups. Intention-to-treat analysis was conducted using Kaplan-Meier methods with log-rank tests and Cox proportional hazard models; cumulative mortality incidence, between-group differences, and relative risks were also assessed at predefined time periods.
RESULTS AND LIMITATIONS


During 22.1yr (median follow-up for survivors=18.6yr; interquartile range: 16.6-20.0), 515 men died; 246 of 346 men (68%) were assigned to surgery versus 269 of 367 (73%) assigned to observation (hazard ratio 0.84 [95% confidence interval {CI}: 0.70-1.00]; p= 0.044 [absolute risk reduction = 5.7 percentage points, 95% CI: -0.89 to 12%]; relative risk: 0.92 [95% CI: 0.84-1.01]). The restricted mean survival in the surgical group was 13.6 yr (95% CI: 12.9-14.3) versus 12.6 yr (95% CI: 11.8-13.3) in the observation group; a mean of 1 life-year was gained with surgery. Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease. Results were not adjusted for multiple comparisons, and we could not assess outcomes other than all-cause mortality.
CONCLUSIONS


Surgery was associated with small very long-term reductions in all-cause mortality and increases in years of life gained. Absolute effects did not vary markedly by patient characteristics. Absolute effects and mean survival were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease.
PATIENT SUMMARY


In this randomized study, we evaluated death from any cause in men with early prostate cancer treated with either surgery or observation. Overall, surgery may provide small very long-term reductions in death from any cause and increases in years of life gained. Absolute effects were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease. Strategies are needed to identify men needing and benefitting from surgery while reducing ineffective treatment and overtreatment.",2020,"Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease.","['men with early prostate cancer', 'Veterans Affairs and National Cancer Institute sites', '50', 'men with early prostate cancer treated with either surgery or observation', 'participants were men (n\u202f=\u202f731) ≤75', 'Clinically Localized Prostate Cancer', 'yr of age with localized prostate cancer, prostate-specific antigen (PSA']","['Radical prostatectomy versus observation', 'Radical Prostatectomy or Observation']","['mean survival', 'Absolute effects and mean survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.16697,"Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wilt', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA. Electronic address: Tim.wilt@va.gov.'}, {'ForeName': 'Tien N', 'Initials': 'TN', 'LastName': 'Vo', 'Affiliation': 'University of Minnesota School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Langsetmo', 'Affiliation': 'University of Minnesota School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Dahm', 'Affiliation': 'Minneapolis VA Section of Urology, Minneapolis MN, USA; Department of Urology, University of Minnesota, Minneapolis MN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wheeler', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Aronson', 'Affiliation': 'VA Medical Center, Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Urology, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California at San Francisco, CA, USA; Department of Urology and Epidemiology and Biostatistics, University of California at San Francisco, CA, USA.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Taylor', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Brawer', 'Affiliation': 'MDx Health, Irvine, CA, USA; Nanospectra Biosciences, Houston, TX, USA.'}]",European urology,['10.1016/j.eururo.2020.02.009']
3530,31727428,Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up.,"PURPOSE


To report 3-year results of the Primary Tube Versus Trabeculectomy (PTVT) Study.
DESIGN


Unmasked multicenter randomized clinical trial.
PARTICIPANTS


Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group.
METHODS


Patients were enrolled at 16 clinical centers and were assigned randomly to treatment with a tube shunt (350-mm 2  Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes).
MAIN OUTCOME MEASURES


The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures included IOP, glaucoma medical therapy, visual acuity, and surgical complications.
RESULTS


The cumulative probability of failure after 3 years of follow-up was 33% in the tube group and 28% in the trabeculectomy group (P = 0.17; hazard ratio, 1.39; 95% confidence interval, 0.9-2.2). Mean ± standard deviation IOP was 14.0±4.2 mmHg in the tube group and 12.1±4.8 mmHg in the trabeculectomy group at 3 years (P = 0.008), and the number of glaucoma medications was 2.1±1.4 in the tube group and 1.2±1.5 in the trabeculectomy group (P < 0.001). Serious complications requiring reoperation or producing loss of 2 or more Snellen lines developed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11).
CONCLUSIONS


There was no significant difference in the rate of surgical failure between the 2 surgical procedures at 3 years. Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study. Serious complications producing vision loss or requiring reoperation occurred with similar frequency after both surgical procedures.",2020,Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study.,"['Patients were enrolled at 16 clinical centers', 'Two hundred forty-two eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 in the tube group and 117 in the trabeculectomy group']","['tube shunt surgery', 'tube shunt (350-mm 2  Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC; 0.4 mg/ml for 2 minutes', 'Trabeculectomy with MMC', 'Primary Tube Versus Trabeculectomy (PTVT']","['Serious complications requiring reoperation or producing loss of 2 or more Snellen lines', 'Mean ± standard deviation IOP', 'cumulative probability of failure', 'rate of surgical failure', 'number of glaucoma medications', 'rate of surgical failure, defined as intraocular pressure (IOP) of more than 21 mmHg or reduced less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision', 'IOP, glaucoma medical therapy, visual acuity, and surgical complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303409', 'cui_str': '117-In'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",242.0,0.165416,Trabeculectomy with MMC achieved lower IOP with use of fewer glaucoma medications compared with tube shunt surgery after 3 years of follow-up in the PTVT Study.,"[{'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Gedde', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: sgedde@med.miami.edu.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Feuer', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kin Sheng', 'Initials': 'KS', 'LastName': 'Lim', 'Affiliation': 'St. Thomas Hospital, London, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': ""Queen Mary's Hospital, Sidcup, United Kingdom.""}, {'ForeName': 'Iqbal I K', 'Initials': 'IIK', 'LastName': 'Ahmed', 'Affiliation': 'University of Toronto, Toronto, Canada.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brandt', 'Affiliation': 'Department of Ophthalmology, University of California, Davis, Sacramento, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.10.002']
3531,31302802,An Exploratory RCT to Support Gamblers' Intentions to Stick to Monetary Limits: A Brief Intervention Using Action and Coping Planning.,"The aim of this study was to investigate the feasibility and impact of an action and coping planning intervention deployed in gambling venues to improve adherence to expenditure limits. We conducted a 2-group parallel-block randomised controlled trial comparing one 20-min session of action and coping planning to an assessment alone. Gamblers who were intending to set a monetary limit on EGMs (n = 184) were recruited in venues and administered the intervention prior to gambling. Measures were adherence to self-identified gambling limits and adherence to expenditure intentions at 30-days post-intervention using the Time Line Follow-Back. The intervention was feasible in terms of recruitment and willingness of gamblers to engage in a pre-gambling intervention. Most gamblers enacted strategies to limit their gambling prior to entering the venue, albeit these limits were on average higher than the Australian low risk gambling guidelines. In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment. However, Moderate Risk/Problem Gamblers in the Intervention group spent less (a median of $60 less) than intended (median $100) within the venue. All intervention participants intended to spend significantly less in the 30 days after the intervention compared to the amount spent in the 30 days prior to the intervention. This reduction was not found for participants in the control group. A simple brief intervention appears feasible in gambling venues and have an impact on gambling intentions over the short term.",2020,"In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment.",['Gamblers who were intending to set a monetary limit on EGMs (n\u2009=\u2009184) were recruited in venues and administered the intervention prior to gambling'],"['action and coping planning intervention', 'action and coping planning']","['gambling intentions', 'adherence to self-identified gambling limits and adherence to expenditure intentions']","[{'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",60.0,0.0387778,"In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment.","[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Rodda', 'Affiliation': 'School of Population Health, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. s.rodda@auckland.ac.nz.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Bagot', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Turning Point, Eastern Health, 110 Church Street, Richmond, VIC, 3121, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Turning Point, Eastern Health, 110 Church Street, Richmond, VIC, 3121, Australia.'}]",Journal of gambling studies,['10.1007/s10899-019-09873-w']
3532,32077301,Effects of Intervention Characteristics on Willingness to Initiate a Weight Gain Prevention Program.,"PURPOSE


To determine characteristics of weight gain prevention programs that facilitate engagement.
DESIGN


Randomized factorial experiment (5 × 2).
SETTING


Recruited nationally online.
PARTICIPANTS


Adults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498).
MEASURES


Participants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only; physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring). Participants reported willingness to join the programs, perceived program effectiveness, and reasons for declining enrollment.
ANALYSIS


Logistic regression and linear regression to test effects of program characteristics offered on willingness to initiate programs and programs' perceived effectiveness, respectively. Content analyses for open-ended text responses.
RESULTS


Participants offered the self-weighing-only programs were more willing to initiate than those offered the programs targeting all 3 behaviors combined (50% vs 36%; odds ratio [OR] = 1.79; 95% confidence interval [CI], 1.01-3.13). Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34,  P  = .02) than those offered no financial incentives. Reasons for declining to initiate included specific program features, behavior targets, social aspects, and benefits.
CONCLUSION


Targeting self-weighing and providing financial incentives for self-monitoring may result in greater uptake of weight gain prevention programs.
STUDY PREREGISTRATION


https://osf.io/b9zfh, June 19, 2018.",2020,"Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34,  P  = .02) than those offered no financial incentives.","['Adults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498', 'Participants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only', 'Recruited nationally online', 'https://osf.io/b9zfh , June 19, 2018']","['physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring']",['intervention effectiveness'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0528058,"Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34,  P  = .02) than those offered no financial incentives.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Marissa L', 'Initials': 'ML', 'LastName': 'Donahue', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'JeeWon', 'Initials': 'J', 'LastName': 'Cheong', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bacon', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120905709']
3533,31375051,Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study.,"Objective:  To evaluate the efficacy and safety of dasotraline for treatment of ADHD in children.  Method:  Children (ages 6-12 years;  N  = 112) with ADHD were randomized, double-blind, to 14 days of once-daily evening doses of dasotraline 4 mg or placebo. ADHD symptom severity was measured at baseline and Day 15 in seven, 30-min classroom sessions using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and the Permanent Product Measure of Performance (PERMP) math test.  Results:  Significant improvement was observed for dasotraline versus placebo in the SKAMP-combined score (-3.2 vs. +2.0;  p  < .001; effect size = 0.85) and SKAMP and PERMP subscale scores. The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%).  Conclusion:  In this laboratory classroom study, dasotraline 4 mg was found to be an efficacious and generally well-tolerated treatment for ADHD in children aged 6 to 12 years.",2020,"The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%).  ","['children', 'Children With ADHD', 'children aged 6 to 12 years', 'Method:  Children (ages 6-12 years', 'N  = 112) with ADHD']","['dasotraline', 'Dasotraline', 'placebo', 'dasotraline 4 mg or placebo']","['headache', 'ADHD symptom severity', 'SKAMP and PERMP subscale scores', 'efficacy and safety', 'Efficacy and Safety', 'insomnia', 'appetite']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C4276542', 'cui_str': '4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",,0.275235,"The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%).  ","[{'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Wigal', 'Affiliation': 'AVIDA Inc., Newport Beach, CA, USA.'}, {'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Hopkins', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Koblan', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.'}, {'ForeName': 'Justine M', 'Initials': 'JM', 'LastName': 'Kent', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",Journal of attention disorders,['10.1177/1087054719864644']
3534,32077050,Influence of a Planning Intervention on Physical Activity Behavior: the Moderating Role of Intentions and Executive Functions in a Randomized Controlled Trial.,"BACKGROUND


Planning and executive functions (EFs; inhibition, updating, shifting) are self-regulatory variables that help people to become and stay physically active. The aim of this study was to examine how and for whom a planning intervention affects physical activity (PA) behavior in the short term. Therefore, the mediating role of planning and the moderating role of intentions and EFs for the planning-behavior link were examined.
METHOD


In a randomized control trial with two treatment groups (planning group vs. control group) and two points of measurement (t1 and t2, 1 week apart), n = 200 students participated in both measurements. At t1, participants filled in standardized questionnaires assessing PA behavior, intention, and planning. Computer-based tests assessed the following EFs: inhibition, updating, and shifting. At t2, planning and PA behavior were measured again. Moderated mediation analyses were conducted.
RESULTS


A significant increase in PA between t1 and t2 was found for the planning group compared with the control group. Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior. Forming plans was particularly beneficial for participants with high intentions and lower updating performance.
CONCLUSION


Planning enhances PA behavior, particularly when PA intention is high. Poor performance in updating can be compensated by planning since encouraging people to generate plans might facilitate automatic enactment of the behavior.",2020,"Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior.",['participants with high intentions and lower updating performance'],"['Planning Intervention', 'planning intervention']","['physical activity (PA) behavior', 'PA', 'Physical Activity Behavior']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",200.0,0.0249912,"Furthermore, planning cognitions significantly mediated the effect of the planning group on behavior and intention, as well as the EF updating moderated the association between planning and behavior.","[{'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Pfeffer', 'Affiliation': 'Medical School Hamburg, Faculty of Human Science, University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457, Hamburg, Germany. ines.pfeffer@medicalschool-hamburg.de.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Strobach', 'Affiliation': 'Medical School Hamburg, Faculty of Human Science, University of Applied Sciences and Medical University, Am Kaiserkai 1, 20457, Hamburg, Germany.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09864-x']
3535,31311060,[Teacher-Based Health Promotion in Primary School Children in Baden-Württemberg: Effects on Endurance Performance and Incidence of Abdominal Obesity].,"BACKGROUND


Health promotion has to start early. Many prevention programmes lack proof of effectiveness. A programme that promotes an active and healthy lifestyle for primary school children in Baden-Württemberg is ""Join the Healthy Boat"".
AIM


The effect of this one-year school-based intervention on endurance performance and incidence of paediatric abdominal obesity was investigated in a large cluster randomised study.
METHODS


Data of 1739 children (7.1±0.6 years) were available at baseline and follow-up. Background variables were assessed via parent questionnaires. Endurance performance (6-minute run) and anthropometric data were collected on-site. Children with waist-to-height-ratio (WHtR) ≥ 0.5 were classified as being abdominally obese. The difference in endurance capacity and the incidence of abdominal obesity between baseline and follow-up were calculated and analysed in simple and hierarchical regression models taking into account the school effect.
RESULTS


Adjusted for gender and grade level, the difference in completed meters in the intervention group after one year was significantly greater (70.5±128.6 vs. 59.2±106.6 m, n=1708). However, after taking into account data clustering of schools, the significance was lost. Odds for the development of abdominal obesity in the intervention group were more than halved after adjustment for gender, grade, baseline WHtR and no-breakfasts (odds ratio=0.48, 95% CI [0.25; 0.94], n=1535).
CONCLUSION


Children should learn to make healthy choices from an early age. With the prevention of abdominal obesity as an indicator, this intervention is characterised as an effective health promotion.",2020,"Odds for the development of abdominal obesity in the intervention group were more than halved after adjustment for gender, grade, baseline WHtR and no-breakfasts (odds ratio=0.48, 95% CI [0.25; 0.94], n=1535).
","['Data of 1739 children (7.1±0.6 years', 'Children with waist-to-height-ratio (WHtR) ≥ 0.5 were classified as being abdominally obese', 'primary school children in Baden-Württemberg', 'Primary School Children in Baden-Württemberg']","['Teacher-Based Health Promotion', 'year school-based intervention']","['abdominal obesity', 'endurance capacity and the incidence of abdominal obesity', 'Endurance performance (6-minute run) and anthropometric data', 'endurance performance and incidence of paediatric abdominal obesity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]",1739.0,0.107244,"Odds for the development of abdominal obesity in the intervention group were more than halved after adjustment for gender, grade, baseline WHtR and no-breakfasts (odds ratio=0.48, 95% CI [0.25; 0.94], n=1535).
","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Kobel', 'Affiliation': 'Sport- und Rehabilitationsmedizin, Universitätsklinikum Ulm, Ulm.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Kesztyüs', 'Affiliation': 'Institut für Allgemeinmedizin, Universität Ulm, Ulm.'}, {'ForeName': 'Jürgen Michael', 'Initials': 'JM', 'LastName': 'Steinacker', 'Affiliation': 'Sport- und Rehabilitationsmedizin, Universitätsklinikum Ulm, Ulm.'}]",Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)),['10.1055/a-0921-7076']
3536,32078058,Cost-effectiveness analysis of voice rehabilitation for patients with laryngeal cancer: a randomized controlled study.,"INTRODUCTION


Voice problems are common following radiotherapy for laryngeal cancer. Few studies exist covering the effect of voice rehabilitation, and no previous studies exist regarding the cost of said rehabilitation. This randomized controlled study aimed to analyze the cost-effectiveness of voice rehabilitation after radiotherapy for patients with laryngeal cancer.
MATERIAL AND METHODS


A total of 66 patients with laryngeal cancer with follow-up data 12 months post-radiotherapy were included. Patients were randomized into receiving either voice rehabilitation (n = 32) or no voice rehabilitation (n = 34). The patient outcome was measured as quality-adjusted life years (QALYs). The index range between 0 and 1, where 0 equals death and 1 represents perfect health. The QALYs were assessed with the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30 mapped to EuroQoL 5 Dimension values. The cost of rehabilitation and other healthcare visits was derived from hospital systems. The patients reported the total amount of sick leave days during the first 12 months following radiotherapy. The cost-effectiveness of the voice rehabilitation was compared with no rehabilitation intervention based on the incremental cost-effectiveness ratio.
RESULTS


The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome. From a healthcare perspective, the voice rehabilitation indicates a cost 60,800 € (SEK 552,725) per gained QALY.
CONCLUSION


From a societal perspective, i.e., including the costs of production loss, voice rehabilitation compared to no voice rehabilitation following radiotherapy for laryngeal cancer seems to be cost-saving. When analyzing only the healthcare costs in relation to health outcomes, voice rehabilitation indicates an incremental cost of 60,800 € per gained QALY, which is just above the threshold of the maximum willingness to pay level.",2020,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","['patients with laryngeal cancer', '66 patients with laryngeal cancer with follow-up data 12\xa0months post-radiotherapy were included']","['voice rehabilitation after radiotherapy', 'voice rehabilitation (n\u2009=\u200932) or no voice rehabilitation', 'radiotherapy', 'voice rehabilitation']","['cost-effectiveness', 'total amount of sick leave days', 'quality-adjusted life years (QALYs', 'cost of rehabilitation and other healthcare visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007107', 'cui_str': 'Cancer of Larynx'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]",66.0,0.0321077,"The cost per gained QALY with voice rehabilitation compared to no rehabilitation from a societal perspective was - 27,594 € (SEK - 250,852) which indicates that the voice rehabilitation is a cost-saving alternative compared to no rehabilitation due to lower costs and a slightly better health outcome.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Finizia', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Health Economics and Policy, School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuomi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden. lisa.tuomi@gu.se.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05362-8']
3537,32078064,Significant decrease of von Willebrand factor and plasminogen activator inhibitor-1 by providing supplementation with selenium and coenzyme Q10 to an elderly population with a low selenium status.,"PURPOSE


Endothelial dysfunction and inflammation are conditions which fuel atherosclerosis and ischaemic heart disease. We have previously reported reduced cardiovascular (CV) mortality following supplementation with selenium and coenzyme Q10 to 443 elderly individuals with low selenium status (mean 67 μg/L) for 4 years. Here, we wanted to evaluate a possible association between the supplementation and the plasma concentrations of the von Willebrand factor (vWf), and the plasminogen activator inhibitor-1 (PAI-1), as they, besides other functions, are also strongly associated with endothelial function.
METHODS


In this sub-study, 308 individuals (active substance: 157, placebo: 151) were included. Blood samples were drawn after 6 and 36 months and vWf and PAI-1 were determined in plasma by ELISA. Changes in concentrations of the biomarkers were evaluated by the use of T tests, repeated measures of variance, and ANCOVA analyses.
RESULTS


The active treatment group presented a lower level of vWf after 36 months compared with the placebo group (1.08 U/mL vs. 5.10 U/mL; p = 0.0007). The results were validated through the repeated measures of variance evaluation. The PAI-1 levels showed an equally significant decrease in the active group (26.2 ng/mL vs. 49.2 ng/mL; p = 0.0002) and were also validated through repeated measures of variance evaluation.
CONCLUSION


In this sub-study on elderly receiving selenium and coenzyme Q10, or placebo we found significantly lower levels of vWf and PAI-1 in the active treatment group as compared to the placebo group. We interpret this as a better endothelial function because of the intervention, which accords with a previous finding of reduced CV mortality.",2020,The active treatment group presented a lower level of vWf after 36 months compared with the placebo group (1.08 U/mL vs. 5.10 U/mL; p = 0.0007).,"['elderly population with a low selenium status', '443 elderly individuals with low selenium status (mean 67\xa0μg/L) for 4\xa0years', '308 individuals (active substance: 157, placebo: 151) were included']","['placebo', 'selenium and coenzyme Q10', 'selenium and coenzyme Q10, or placebo', 'supplementation with selenium and coenzyme Q10']","['plasma concentrations of the von Willebrand factor (vWf), and the plasminogen activator inhibitor-1 ', 'von Willebrand factor and plasminogen activator inhibitor-1', 'cardiovascular (CV) mortality', 'PAI-1 levels', 'levels of vWf and PAI-1']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",443.0,0.220701,The active treatment group presented a lower level of vWf after 36 months compared with the placebo group (1.08 U/mL vs. 5.10 U/mL; p = 0.0007).,"[{'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Alehagen', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medical and Health Sciences, Linköping University, 581 85, Linköping, Sweden. Urban.Alehagen@liu.se.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alexander', 'Affiliation': 'Norwegian Institute of Public Health, 0403, Oslo, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Aaseth', 'Affiliation': 'Research Department, Innlandet Hospital Trust, 2381, Brumunddal, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, 751 85, Uppsala, Sweden.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Lindahl', 'Affiliation': 'Division of Clinical Chemistry, Department of Experimental and Clinical Medicine, Linköping University, 581 85, Linköping, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02193-5']
3538,32078170,The Safety and Efficacy of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Laryngologic Surgery.,"OBJECTIVES


Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) is an intraoperative ventilatory technique that allows avoidance of tracheal intubation (TI) or jet ventilation (JV) in selected laryngologic surgical cases. Unimpeded access to all parts of the glottis may improve surgical precision, decrease operative time, and potentially improve patient outcomes. The objective of this prospective, randomized, patient-blinded, 2-arm parallel pilot trial was to investigate the safety and efficacy of THRIVE use for adult patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration.
METHODS


Twenty adult, American society of anesthesiology class 1-3 patients with body mass index (BMI) < 35 kg/m 2  were randomly assigned to either an experimental THRIVE group or active comparator conventional ventilation group (TI or supraglottic high-frequency JV [SHFJV]). Primary outcomes included intraoperative oxygenation, anesthesia awakening/extubation time, time to laryngoscopic suspension, number of intraoperative suspension adjustments, and operative time. Secondary patient outcomes including postanesthesia and functional patient recovery were investigated.
RESULTS


Compared to TI/SHFJV, THRIVE use was associated with significantly lower intraoperative oxygenation (SpO 2  93.0 ± 5.6% vs. 98.7 ± 1.6%), shorter time to suspension (1.8 ± 1.1 minutes vs. 4.3 ± 2.1 minutes), fewer suspension adjustments (0.4 ± 0.5 vs. 1.7 ± 0.9), and lower postoperative pain scores on recovery room admission (1.3 ± 1.9 vs. 3.7 ± 2.9) and discharge (0.9 ± 1.3 vs. 2.7 ± 1.8). The study was underpowered to detect other possible outcome differences.
CONCLUSION


We confirm the safe intraoperative oxygenation profile of THRIVE for selected patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration. THRIVE facilitated surgical exposure and improved early patient recovery, suggesting a potential economic benefit for outpatient laryngologic procedures. The results of this exploratory study provide a framework for designing future adequately powered THRIVE trials.
TRIAL REGISTER


ClinicalTrials.gov (NCT03091179).
LEVEL OF EVIDENCE


II Laryngoscope, 2020.",2020,"Unimpeded access to all parts of the glottis may improve surgical precision, decrease operative time, and potentially improve patient outcomes.","['selected laryngologic surgical cases', 'Twenty adult, American society of anesthesiology class 1-3 patients with body mass index (BMI)\u2009<\u200935\u2009kg/m 2', 'Laryngologic Surgery', 'selected patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration', 'adult patients undergoing nonlaser laryngologic surgery of short-to-intermediate duration']","['Transnasal Humidified Rapid-Insufflation Ventilatory Exchange', 'tracheal intubation (TI) or jet ventilation (JV', 'experimental THRIVE group or active comparator conventional ventilation group (TI or supraglottic high-frequency JV [SHFJV', 'Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE']","['postoperative pain scores', 'intraoperative oxygenation, anesthesia awakening/extubation time, time to laryngoscopic suspension, number of intraoperative suspension adjustments, and operative time', 'surgical precision, decrease operative time', 'intraoperative oxygenation', 'safety and efficacy', 'postanesthesia and functional patient recovery', 'shorter time to suspension']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C2938208', 'cui_str': 'Thrive'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",20.0,0.150251,"Unimpeded access to all parts of the glottis may improve surgical precision, decrease operative time, and potentially improve patient outcomes.","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Nekhendzy', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Brita', 'Initials': 'B', 'LastName': 'Mittal', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Kwang', 'Initials': 'K', 'LastName': 'Sung', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Karuna', 'Initials': 'K', 'LastName': 'Dewan', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Damrose', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, CA, USA.'}]",The Laryngoscope,['10.1002/lary.28562']
3539,31770471,Between placebo and nocebo: Response to control treatment is mediated by amygdala activity and connectivity.,"BACKGROUND


In experimental placebo and nocebo studies, neutral control treatments are often administered for comparison with active treatments, but are of little interest, as, on average, they result in little change. Yet, when considered at an individual level, they fluctuate between baseline and subsequent measurements and may reveal important information about participants' placebo/nocebo responding tendencies.
METHODS


In a paradigm involving application of creams paired with positive, negative and neutral expectations, some subjects rated identical stimuli in the neutral condition as more painful while others as less painful after treatment with inert cream. We divided subjects into two groups based on the median split in these pre-post responses in the neutral control condition, and investigated (a) fMRI signal differences (post minus pre) between the two groups in neutral condition, and (b) seed-based resting state connectivity of the bilateral amygdala, known to be involved in emotional self-regulation, as well as ambiguous stimulus processing and aversive learning.
RESULTS


The results suggested that subjects who rated the same pain stimuli after treatment with explicitly neutral cream as more painful showed stronger fMRI activation of the amygdala during the experiment and had higher connectivity between the left amygdala and the striatum at rest. Neutral pre-post changes predicted behavioural placebo/nocebo response in this and two independent datasets.
CONCLUSION


These findings suggest that measuring pre-post change in the neutral control condition might provide important information about subjects' individual differences in placebo/nocebo response.
SIGNIFICANCE


Pre-post changes in pain ratings in neutral conditions are modulated by amygdala activity and connectivity and can be used to predict placebo/nocebo responses.",2020,Neutral pre-post changes predicted behavioral placebo/nocebo response in this and 2 independent datasets.,[],['placebo and nocebo'],"['amygdala activity and connectivity response', 'fMRI activation', 'pain stimuli']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.208563,Neutral pre-post changes predicted behavioral placebo/nocebo response in this and 2 independent datasets.,"[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Egorova', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Benedetti', 'Affiliation': 'University of Turin, Turin, Italy.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Charlestown, MA, USA.'}]","European journal of pain (London, England)",['10.1002/ejp.1510']
3540,29540325,Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study.,"BACKGROUND


Randomized trials demonstrated a lower risk of cardiovascular (CV) events with sodium-glucose cotransporter-2 inhibitors (SGLT-2i) in patients with type 2 diabetes (T2D) at high CV risk. Prior real-world data suggested similar SGLT-2i effects in T2D patients with a broader risk profile, but these studies focused on heart failure and death and were limited to the United States and Europe.
OBJECTIVES


The purpose of this study was to examine a broad range of CV outcomes in patients initiated on SGLT-2i versus other glucose-lowering drugs (oGLDs) across 6 countries in the Asia Pacific, the Middle East, and North American regions.
METHODS


New users of SGLT-2i and oGLDs were identified via claims, medical records, and national registries in South Korea, Japan, Singapore, Israel, Australia, and Canada. Propensity scores for SGLT-2i initiation were developed in each country, with 1:1 matching. Hazard ratios (HRs) for death, hospitalization for heart failure (HHF), death or HHF, MI, and stroke were assessed by country and pooled using weighted meta-analysis.
RESULTS


After propensity-matching, there were 235,064 episodes of treatment initiation in each group; ∼27% had established CV disease. Patient characteristics were well-balanced between groups. Dapagliflozin, empagliflozin, ipragliflozin, canagliflozin, tofogliflozin, and luseogliflozin accounted for 75%, 9%, 8%, 4%, 3%, and 1% of exposure time in the SGLT-2i group, respectively. Use of SGLT-2i versus oGLDs was associated with a lower risk of death (HR: 0.51; 95% confidence interval [CI]: 0.37 to 0.70; p < 0.001), HHF (HR: 0.64; 95% CI: 0.50 to 0.82; p = 0.001), death or HHF (HR: 0.60; 95% CI: 0.47 to 0.76; p < 0.001), MI (HR: 0.81; 95% CI: 0.74 to 0.88; p < 0.001), and stroke (HR: 0.68; 95% CI: 0.55 to 0.84; p < 0.001). Results were directionally consistent across both countries and patient subgroups, including those with and without CV disease.
CONCLUSIONS


In this large, international study of patients with T2D from the Asia Pacific, the Middle East, and North America, initiation of SGLT-2i was associated with a lower risk of CV events across a broad range of outcomes and patient characteristics. (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors [CVD-REAL]; NCT02993614).",2018,"Use of SGLT-2i versus oGLDs was associated with a lower risk of death (HR: 0.51; 95% confidence interval [CI]: 0.37 to 0.70; p < 0.001), HHF (HR: 0.64; 95% CI: 0.50 to 0.82; p = 0.001), death or HHF (HR: 0.60; 95% CI: 0.47 to 0.76; p < 0.001), MI (HR: 0.81; 95% CI: 0.74 to 0.88; p < 0.001), and stroke (HR: 0.68; 95% CI: 0.55 to 0.84; p < 0.001).","['New users of SGLT-2i and oGLDs were identified via claims, medical records, and national registries in South Korea, Japan, Singapore, Israel, Australia, and Canada', 'patients with type 2 diabetes (T2D) at high CV risk', 'patients with T2D from the Asia Pacific, the Middle East, and North America', 'patients initiated on SGLT-2i versus other glucose-lowering drugs (oGLDs) across 6 countries in the Asia Pacific, the Middle East, and North American regions', 'T2D patients with a broader risk profile']","['Inhibitors Versus Other Glucose-Lowering Drugs', 'SGLT-2', 'SGLT-2i', 'Dapagliflozin, empagliflozin, ipragliflozin, canagliflozin, tofogliflozin, and luseogliflozin', 'sodium-glucose cotransporter-2 inhibitors (SGLT-2i']","['risk of death', 'death or HHF', 'Hazard ratios (HRs) for death, hospitalization for heart failure (HHF), death or HHF, MI, and stroke', 'established CV disease']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0026068', 'cui_str': 'Middle East'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C3501434'}, {'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.330292,"Use of SGLT-2i versus oGLDs was associated with a lower risk of death (HR: 0.51; 95% confidence interval [CI]: 0.37 to 0.70; p < 0.001), HHF (HR: 0.64; 95% CI: 0.50 to 0.82; p = 0.001), death or HHF (HR: 0.60; 95% CI: 0.47 to 0.76; p < 0.001), MI (HR: 0.81; 95% CI: 0.74 to 0.88; p < 0.001), and stroke (HR: 0.68; 95% CI: 0.55 to 0.84; p < 0.001).","[{'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Department of Cardiovascular Disease, Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: mkosiborod@saint-lukes.org.""}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre, Singapore and SingHealth Duke-NUS, Singapore; University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Dae Jung', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Karasik', 'Affiliation': 'Institute of Endocrinology, Tel Aviv University and Maccabi Healthcare Israel, Tel Aviv, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Clinical and Population Health, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Navdeep', 'Initials': 'N', 'LastName': 'Tangri', 'Affiliation': 'Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Su-Yen', 'Initials': 'SY', 'LastName': 'Goh', 'Affiliation': 'Department of Endocrinology, Singapore General Hospital, Singapore.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Thuresson', 'Affiliation': 'Statisticon AB, Uppsala, Sweden.'}, {'ForeName': 'Hungta', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Surmont', 'Affiliation': 'AstraZeneca, Luton, United Kingdom.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Hammar', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden; AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fenici', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2018.03.009']
3541,32072772,A randomized controlled trial examining an exam room poster to prompt communication about weight.,"BACKGROUND


Recognition of childhood weight status is important to the adoption of healthy lifestyle behaviours.
OBJECTIVES


We assessed whether an exam room educational poster addressing weight and healthy lifestyle behaviours was acceptable to parents, prompted parent-provider communication or improved parental weight perception accuracy.
METHODS


In this multi-site randomized controlled trial, exam rooms were randomized to display the posters (English and Spanish) or not. Children ages 3 to 8 years (N = 965) attending well visits were weighed and roomed per usual clinic protocol. After the visit, parents completed a questionnaire assessing demographics, child weight status perceptions and whether they discussed weight status with provider or were shown growth charts. We used separate logistic regression analyses to examine associations between intervention status and: asking provider about child weight, being shown growth charts, and accuracy of weight perception, adjusting for covariates and clustering by exam room.
RESULTS


Of the parents who saw the poster, 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%). Parents who saw the poster were more likely to report being shown a growth chart (OR 1.87, 95% 1.06, 3.30) but were not more likely to ask about their child's weight status nor accurately report their child's weight status.
CONCLUSIONS


An educational exam room poster about healthy weight was well-received by parents and prompted providers to show the child's growth chart but did not prompt parent-initiated conversations about weight status nor improve parental weight perception accuracy.",2020,", 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%).",['Children ages 3 to 8\u2009years (N = 965) attending well visits were weighed and roomed per usual clinic protocol'],[],"['healthy lifestyle behaviours', 'weight status visualization']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]",[],"[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",965.0,0.0279247,", 97% liked seeing it and reported greater understanding of weight status visualization (96%) and healthy lifestyle behaviours (94%).","[{'ForeName': 'Callie L', 'Initials': 'CL', 'LastName': 'Brown', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Janna B', 'Initials': 'JB', 'LastName': 'Howard', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, North Carolina.'}]",Pediatric obesity,['10.1111/ijpo.12625']
3542,31836995,Vitamin D Supplementation Ameliorates Severity of Major Depressive Disorder.,"Major depressive disorder is a serious neuropsychiatric disease that leads to significant impairment in social functioning and increased morbidity and mortality. Low vitamin D (25-OH D) levels have been hypothesized to contribute to the pathophysiology of MDD. To investigate the therapeutic role of vitamin D in MDD, we recruited 62 male and female patients diagnosed with MDD and randomized them into two groups: the first group (49 patients) received vitamin D supplementation as cholecalciferol vitamin D 3  (50,000 I.U.) for 3 months, in addition to standard of care (SOC) which included pharmacological treatment and psychological support, and the second group (13 patients) received only SOC without vitamin D supplementation for 3 months. The Beck depression inventory (BDI) scale was used to assess the severity of MDD symptoms. Immunoassays were utilized to determine levels of serum vitamin D 3  and serotonin in all patients. The results showed significant gender differences; female patients showed the most improvement in their depressive symptoms after 3-month vitamin D supplementation. Females with moderate, severe, and extreme depression had significantly lower BDI scores after vitamin D treatment (p < 0.05). Among males, only those diagnosed with severe depression showed significant improvement in their BDI scores (p < 0.05). Serum serotonin levels were significantly increased after vitamin D supplementation compared to baseline in both male and female patients. No significant changes in other biochemical parameters were detected between the two groups. These findings suggest that vitamin D supplementation may ameliorate symptoms of MDD, particularly in females, via a serotonin-dependent mechanism.",2020,"Among males, only those diagnosed with severe depression showed significant improvement in their BDI scores (p < 0.05).","['62 male and female patients diagnosed with MDD and randomized them into two groups: the first group (49 patients) received', 'male and female patients']","['vitamin D supplementation', 'vitamin D supplementation as cholecalciferol vitamin D 3  (50,000 I.U.) for 3\xa0months, in addition to standard of care (SOC) which included pharmacological treatment and psychological support, and the second group (13 patients) received only SOC without vitamin D supplementation', 'Low vitamin D (25-OH D', 'Vitamin D Supplementation', 'vitamin D']","['severity of MDD symptoms', 'Serum serotonin levels', 'Beck depression inventory (BDI) scale', 'BDI scores', 'depressive symptoms', 'morbidity and mortality', 'biochemical parameters']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",62.0,0.0483823,"Among males, only those diagnosed with severe depression showed significant improvement in their BDI scores (p < 0.05).","[{'ForeName': 'Shareefa', 'Initials': 'S', 'LastName': 'Alghamdi', 'Affiliation': 'Department of Biochemistry, Faculty of Sciences, King Abdulaziz University, Jeddah, Saudi Arabia. saaalghamdi1@kau.edu.sa.'}, {'ForeName': 'Nabilah', 'Initials': 'N', 'LastName': 'Alsulami', 'Affiliation': 'Department of Biochemistry, Faculty of Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Khoja', 'Affiliation': 'Department of Biochemistry, Faculty of Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Hadeil', 'Initials': 'H', 'LastName': 'Alsufiani', 'Affiliation': 'Department of Biochemistry, Faculty of Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Haythum O', 'Initials': 'HO', 'LastName': 'Tayeb', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Frank I', 'Initials': 'FI', 'LastName': 'Tarazi', 'Affiliation': 'Department of Psychiatry and Neuroscience Program, Harvard Medical School and McLean Hospital, Boston, MA, USA.'}]",Journal of molecular neuroscience : MN,['10.1007/s12031-019-01461-2']
3543,32041601,A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD.,"BACKGROUND


Many patients with chronic obstructive pulmonary disease (COPD) still experience daily symptoms, exacerbations, and accelerated lung function decline, even when receiving maximal combined treatment with inhaled long-acting bronchodilators and corticosteroids. Novel treatment options are needed for these patients. Phosphodiesterases (PDEs) are enzymes that impact a range of cellular functions by modulating levels of cyclic nucleotides, and there is evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive (or perhaps synergistic) effects. This study investigated the efficacy and safety of ensifentrine, a first-in-class dual inhibitor of PDE 3 and 4, in patients with COPD.
METHODS


This randomised, double-blind, placebo-controlled, parallel-group, dose-ranging study recruited patients with COPD, post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) 40-80% predicted and FEV 1 /forced vital capacity ratio ≤ 0.7. Patients were randomised equally to inhale nebulised ensifentrine 0.75, 1.5, 3 or 6 mg or placebo, all twice daily.
PRIMARY OUTCOME


placebo-adjusted difference in peak FEV 1  (assessed over 3 h) at Week 4.
RESULTS


The study took place between July 2017 and February 2018. Of 405 patients randomly assigned to medication, 375 (92.6%) completed the study. For peak FEV 1  at Week 4, all four ensifentrine doses were superior to placebo (p ≤ 0.0001) with least squares mean differences of 146 (95% CI 75-216), 153 (83-222), 200 (131-270) and 139 (69-210) mL for ensifentrine 0.75, 1.5, 3 and 6 mg, respectively. Respiratory symptoms (assessed using the Evaluating Respiratory Symptoms questionnaire) were also significantly improved with all ensifentrine doses at Week 4. Adverse events were reported by 33.3, 44.4, 35.4 and 36.3% patients with ensifentrine 0.75, 1.5, 3 and 6 mg, respectively, and 39.2% with placebo.
CONCLUSIONS


In this four-week Phase IIb study, all four ensifentrine doses significantly improved bronchodilation and symptoms, with a dose-ranging effect from 0.75 to 3 mg twice daily, and all doses well tolerated. The study supports the continuing development of ensifentrine in COPD.
TRIAL REGISTRATION


EudraCT 2016-005205-40, registered 30 May 2017.",2020,"For peak FEV 1  at Week 4, all four ensifentrine doses were superior to placebo (p ≤ 0.0001) with least squares mean differences of 146 (95% CI 75-216), 153 (83-222), 200 (131-270) and 139 (69-210) mL for ensifentrine 0.75, 1.5, 3 and 6 mg, respectively.","['patients with COPD', 'patients with COPD, post-bronchodilator forced expiratory volume in 1\u2009s (FEV 1 ) 40-80% predicted and FEV 1 /forced vital capacity ratio\u2009≤\u20090.7', 'patients with chronic obstructive pulmonary disease (COPD', 'July 2017 and February 2018', '405 patients randomly assigned to medication, 375 (92.6%) completed the study', '2016-005205-40, registered 30 May 2017', 'COPD']","['placebo', 'inhale nebulised ensifentrine 0.75, 1.5, 3 or 6\u2009mg or placebo', 'EudraCT', 'ensifentrine']","['Respiratory symptoms', 'peak FEV 1', 'Adverse events', 'tolerated', 'bronchodilation and symptoms', 'Respiratory Symptoms questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",405.0,0.482718,"For peak FEV 1  at Week 4, all four ensifentrine doses were superior to placebo (p ≤ 0.0001) with least squares mean differences of 146 (95% CI 75-216), 153 (83-222), 200 (131-270) and 139 (69-210) mL for ensifentrine 0.75, 1.5, 3 and 6 mg, respectively.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester & Manchester University NHS Foundation Trust, Manchester, UK. dsingh@meu.org.uk.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, New York, and University of Michigan School of Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'StatMind AB, Lund, Sweden.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Maurer', 'Affiliation': 'Verona Pharma plc, London, UK.'}]",Respiratory research,['10.1186/s12931-020-1307-4']
3544,32062791,Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR).,"PURPOSE


The Phase 3 ENDEAVOUR study evaluated revusiran, an investigational RNA interference therapeutic targeting hepatic transthyretin (TTR) production, for treating cardiomyopathy caused by hereditary transthyretin-mediated (hATTR) amyloidosis.
METHODS


Patients with hATTR amyloidosis with cardiomyopathy were randomized 2:1 to receive subcutaneous daily revusiran 500 mg (n = 140) or placebo (n = 66) for 5 days over a week followed by weekly doses. Co-primary endpoints were 6-min walk test distance and serum TTR reduction.
RESULTS


Revusiran treatment was stopped after a median of 6.71 months; the study Sponsor prematurely discontinued dosing due to an observed mortality imbalance between treatment arms. Eighteen (12.9%) patients on revusiran and 2 (3.0%) on placebo died during the on-treatment period. Most deaths in both treatment arms were adjudicated as cardiovascular due to heart failure (HF), consistent with the natural history of the disease. A post hoc safety investigation of patients treated with revusiran found that, at baseline, a greater proportion of those who died were ≥ 75 years and showed clinical evidence of more advanced HF compared with those who were alive throughout treatment. Revusiran pharmacokinetic exposures and TTR lowering did not show meaningful differences between patients who died and who were alive. Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
CONCLUSIONS


Causes for the observed mortality imbalance associated with revusiran were thoroughly investigated and no clear causative mechanism could be identified. Although the results suggest similar progression of cardiac parameters in both treatment arms, a role for revusiran cannot be excluded.
CLINICAL TRIAL REGISTRATION


NCT02319005.",2020,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","['Patients with hATTR amyloidosis with cardiomyopathy', 'Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR']","['Revusiran', 'subcutaneous daily revusiran 500\xa0mg (n\u2009=\u2009140) or placebo']","['6-min walk test distance and serum TTR reduction', 'echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events', 'mortality imbalance', 'Revusiran pharmacokinetic exposures and TTR lowering']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]","[{'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4505592', 'cui_str': 'revusiran'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",,0.0976805,"Revusiran did not deleteriously affect echocardiographic parameters, cardiac biomarkers, or frequency of cardiovascular and HF hospitalization events.
","[{'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Judge', 'Affiliation': 'Johns Hopkins Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Arnt V', 'Initials': 'AV', 'LastName': 'Kristen', 'Affiliation': 'Department of Cardiology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Grogan', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mathew S', 'Initials': 'MS', 'LastName': 'Maurer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Rodney H', 'Initials': 'RH', 'LastName': 'Falk', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Hanna', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Gillmore', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Harrop', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Hawkins', 'Affiliation': 'National Amyloidosis Centre, Division of Medicine, UCL Medical School Royal Free Hospital Rowland Hill Street, NW3 2PF, London, UK. p.hawkins@ucl.ac.uk.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-019-06919-4']
3545,31773209,Effect of e-cigarette flavors on nicotine delivery and puffing topography: results from a randomized clinical trial of daily smokers.,"RATIONALE


There is limited understanding regarding how various e-cigarette flavorings may influence the behavior of non-regular e-cigarette users who are regular cigarette smokers.
OBJECTIVES


To assess differences in nicotine delivery, puffing topography, subjective effects, and user satisfaction from different flavored e-liquids.
METHODS


Eighteen daily smokers (average age, 44.1 ± 7.0; 9 males; average CPD, 13.0 ± 5.8) smoked their tobacco cigarettes during an initial visit and returned five times to try an e-cigarette (eGo type) refilled with a nicotine solution (24 mg/ml) of five different flavors: cherry, tobacco, espresso, menthol, and vanilla (randomized order). Assessments at each visit included puffing topography, blood samples for nicotine analysis, and subjective reports of nicotine effects and flavor satisfaction.
RESULTS


Vaping different flavors resulted in different levels of plasma nicotine. The flavor producing the highest plasma nicotine concentration (C max ) was cherry (median 21.2 ng/ml), which was not significantly different than nicotine delivery from a combustible cigarette (29.2 ng/ml, p > .05). Vanilla e-liquid produced the lowest C max  (9.7 ng/ml), and participants tended to puff less frequently on vanilla compared to tobacco flavor (p = .013). Flavors did not differ significantly in the speed of nicotine delivery (T max ). During controlled use, puff duration for all flavors was significantly longer than a combustible cigarette (p < 0.05). After controlling for nicotine delivery, significant differences in flavor enjoyment were detected. Menthol flavored e-liquid was rated as more enjoyable than vanilla and tobacco flavored e-liquids (p < 0.05).
CONCLUSIONS


Flavors tested in this study yielded different patterns of nicotine delivery and led to differences in reduction in smoking urges.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: #NCT02575885.",2020,"Menthol flavored e-liquid was rated as more enjoyable than vanilla and tobacco flavored e-liquids (p < 0.05).
","['Eighteen daily smokers (average age, 44.1 ± 7.0; 9 males; average CPD, 13.0 ± 5.8) smoked their tobacco cigarettes during an initial visit and returned five times to try an e-cigarette (eGo type) refilled with a', '24 mg/ml) of five different flavors: cherry, tobacco, espresso, menthol, and vanilla (randomized order']","['nicotine solution', 'e-cigarette flavors']","['highest plasma nicotine concentration (C max ', 'flavor enjoyment', 'speed of nicotine delivery (T max ', 'levels of plasma nicotine']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1533153', 'cui_str': 'Fives'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0330657', 'cui_str': 'Pie Cherry'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0678424', 'cui_str': 'Vanilla (substance)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0706778,"Menthol flavored e-liquid was rated as more enjoyable than vanilla and tobacco flavored e-liquids (p < 0.05).
","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Voos', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, USA. nataliedvoos@gmail.com.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, USA.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Mahoney', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, USA.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Bradizza', 'Affiliation': 'Department of Psychiatry, Jacobs School of Medicine and Biomedical Sciences, Buffalo, USA.'}, {'ForeName': 'Lynn T', 'Initials': 'LT', 'LastName': 'Kozlowski', 'Affiliation': 'School of Public Health and Health Professions, University at Buffalo, Buffalo, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine and Bioengineering & Therapeutic Sciences, University of California San Francisco, San Francisco, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, USA.'}, {'ForeName': 'Maciej L', 'Initials': 'ML', 'LastName': 'Goniewicz', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, USA.'}]",Psychopharmacology,['10.1007/s00213-019-05386-x']
3546,32025522,"Supplementation with Korean Red Ginseng Improves Current Perception Threshold in Korean Type 2 Diabetes Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.","Background


Many Type 2 diabetes (T2DM) patients in Korea take Korean Red Ginseng (KRG) for various reasons. In this study, we investigated the effects of KRG administration on diabetic peripheral neuropathy in T2DM patients.
Methods


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in current perception threshold (CPT) at week 24. Secondary outcomes were altered fasting plasma glucose, HbA1c, and various metabolic and inflammatory markers at week 24.
Results


Sixty-one patients completed the study. The CPT of the lower extremities at various frequencies exhibited significant improvements at week 24 in the KRG group. Other metabolic parameters were not altered after 24 weeks in both groups. In the subgroup analysis, CPT levels were improved in those with a longer diabetes duration or who already had neuropathy at the beginning of the study, and insulin resistance was improved in patients with a shorter diabetes duration.
Conclusion


Twenty-four week administration of KRG in T2DM patients resulted in a significant improvement in neuropathy, especially in those with a longer diabetes duration. A further, larger population study with a longer follow-up period is warranted to verify the effects of KRG on diabetic neuropathy.",2020,Other metabolic parameters were not altered after 24 weeks in both groups.,"['diabetic peripheral neuropathy in T2DM patients', 'Korean Type 2 Diabetes Patients', '\n\n\nMany Type 2 diabetes (T2DM']","['Placebo', 'Korean Red Ginseng', 'KRG', 'placebo', 'Korea take Korean Red Ginseng (KRG', 'placebo or KRG']","['neuropathy', 'insulin resistance', 'altered fasting plasma glucose, HbA1c, and various metabolic and inflammatory markers', 'CPT levels', 'changes in current perception threshold (CPT']","[{'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0022771', 'cui_str': 'Korea'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",61.0,0.400557,Other metabolic parameters were not altered after 24 weeks in both groups.,"[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Junghye', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Shinae', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Republic of Korea.'}]",Journal of diabetes research,['10.1155/2020/5295328']
3547,32039934,Secondary Analysis of Pain Outcomes in a Large Pragmatic Randomized Trial of Buprenorphine/Naloxone Versus Methadone for Opioid Use Disorder.,"OBJECTIVE


Opioid use disorder (OUD) is associated with chronic pain. We investigated the association between medication treatments for OUD and pain in a post-hoc secondary analysis of a randomized trial of methadone versus buprenorphine/naloxone.
METHODS


1241 individuals with OUD participated in an open label, pragmatic randomized trial of methadone versus buprenorphine/naloxone in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009. In this post-hoc analysis, pain was dichotomized (present or not present) using responses from the Short Form-36. Logistic regression models were fit to test the effect of (1) having baseline pain on week 24 retention, (2) treatment assignment on improvement in pain among those reporting pain at baseline, and (3) pain improvement at week 4 on week 24 retention among those reporting pain at baseline.
RESULTS


Almost half (48.2%) of the sample reported pain at baseline. Participants with baseline pain did not significantly differ in week 24 retention compared to those without baseline pain. Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76 [1.10, 2.82], P = 0.020).
CONCLUSION AND RELEVANCE


In this large multisite randomized trial of medication treatments for OUD, nearly half of the participants reported pain at baseline, and improvement in pain early in treatment was associated with increased likelihood of retention in treatment.",2020,"Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76","['in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009', '1241 individuals with OUD participated in an open label, pragmatic randomized trial of']","['methadone', 'Methadone', 'methadone versus buprenorphine/naloxone', 'buprenorphine/naloxone', 'Buprenorphine/Naloxone']","['pain', 'pain improvement', 'Pain Outcomes', 'baseline pain']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",1241.0,0.257531,"Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76","[{'ForeName': 'Matisyahu', 'Initials': 'M', 'LastName': 'Shulman', 'Affiliation': 'New York State Psychiatric Institute, New York, NY, (MS, SL, ANCC, JS, AB, EVN); Department of Psychiatry, Columbia University Medical Center, New York, NY, (MS, SL, ANCC, JS, EVN); Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, (MP); Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine; Center of Excellence in Substance Abuse Treatment and Education VA Puget Sound Health Care System, WA (AJS).'}, {'ForeName': 'Sean X', 'Initials': 'SX', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': ''}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Broffman', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': ''}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000630']
3548,32049889,Does Circadian Rhythm Affect the Pharmacokinetics of Once-Daily Tobramycin in Adults With Cystic Fibrosis?,"BACKGROUND


In the era of multiple daily dosing of systemic aminoglycosides, a circadian rhythm in the clearance of these vital antibiotics has been demonstrated in animals and healthy volunteers. Over the past decade, once-daily dosing regimens have been proved to be less nephrotoxic and were therefore adopted worldwide for most indications requiring treatment with an aminoglycoside. In this study, the effect of the time of administration on the pharmacokinetics of once-daily tobramycin in adults with cystic fibrosis (CF) experiencing a pulmonary exacerbation was investigated.
METHODS


In this open randomized study, patients with CF received intravenous tobramycin at 8:00 or 22:00 hours. Pharmacokinetic and kidney function parameters were compared between the 2 groups.
RESULTS


Twenty-five patients were included. The mean weight-corrected clearances of tobramycin were 1.46 versus 1.43 mL/h*kg (P = 0.50) and mean volumes of distribution were 0.25 versus 0.27 L/kg (P = 0.54) for the 8:00 and 22:00 groups, respectively. In addition, no significant differences were detected in changes in estimated clearances of creatinine or tobramycin on day 1 and day 8 in the 8:00 or 22:00 group, indicating that there was no decline in clearance over time. At day 8 of therapy, the increase in serum blood urea nitrogen in the 22:00 group was significantly higher than that in the 8:00 group (1.8 versus 0.2 mmol/L, P = 0.015).
CONCLUSIONS


The time of administration (8:00 versus 22:00) did not affect tobramycin pharmacokinetics in the adult CF population studied. The increase in serum blood urea nitrogen in the 22:00 group requires further investigation.",2020,"At day 8 of therapy, the increase in serum blood urea nitrogen in the 22:00 group was significantly higher than that in the 8:00 group (1.8 vs. 0.2 mmol/L, p=0.015).
","['animals and healthy volunteers', 'Twenty-five patients were included', 'Adults with Cystic Fibrosis', 'adults with cystic fibrosis (CF) experiencing a pulmonary exacerbation was investigated', 'patients with CF received']","['intravenous tobramycin', 'tobramycin', 'Tobramycin', 'aminoglycoside']","['serum blood urea nitrogen', 'tobramycin pharmacokinetics', 'mean weight-corrected clearances of tobramycin', 'estimated clearances of creatinine or tobramycin']","[{'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",25.0,0.0258946,"At day 8 of therapy, the increase in serum blood urea nitrogen in the 22:00 group was significantly higher than that in the 8:00 group (1.8 vs. 0.2 mmol/L, p=0.015).
","[{'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': '*University Medical Center Utrecht, Clinical Pharmacy, Utrecht; †Haga Teaching Hospital, Pulmonary Diseases, The Hague; ‡CAPHRI, Maastricht University Medical Center, Clinical Pharmacy, Maastricht; §CAPRI, Maastricht; and ¶Central Pharmacy, The Hague, Clinical Pharmacy, the Netherlands. Dr. TouW is now with the Department of Hospital and Clinical Pharmacy, University of Groningen, University Medical Center Groningen, Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Renske', 'Initials': 'R', 'LastName': 'van der Meer', 'Affiliation': ''}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Neef', 'Affiliation': ''}, {'ForeName': 'Harry G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': ''}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000743']
3549,32046718,Usefulness of day 7 lumefantrine plasma concentration as a predictor of malaria treatment outcome in under-fives children treated with artemether-lumefantrine in Tanzania.,"BACKGROUND


Day 7 plasma lumefantrine concentration is suggested as a predictor for malaria treatment outcomes and a cut-off of ≥ 200 ng/ml is associated with day 28 cure rate in the general population. However, day 7 lumefantrine plasma concentration can be affected by age, the extent of fever, baseline parasitaemia, and bodyweight. Therefore, this study assessed the usefulness of day 7 lumefantrine plasma concentration as a predictor of malaria treatment outcome in under-fives children treated with generic or innovator drug-containing artemether-lumefantrine (ALu) in Tanzania.
METHODS


This study was nested in an equivalence prospective study that aimed at determining the effectiveness of a generic ALu (Artefan ® ) in comparison with the innovator's product (Coartem ® ). Children with uncomplicated malaria aged 6-59 months were recruited and randomized to receive either generic or innovator's product. Children were treated with ALu as per World Health Organization recommendations. The clinical and parasitological outcomes were assessed after 28 days of follow up. PCR was performed to distinguish recrudescence and re-infections among children with recurrent malaria. Analysis of day 7 lumefantrine plasma concentration was carried out using a high-performance liquid chromatographic method with UV detection.
RESULTS


The PCR corrected cure rates were 98.7% for children treated with generic and 98.6% for those treated with the innovator product (p = 1.00). The geometric mean (± SD) of day 7 plasma lumefantrine concentration was 159.3 (± 2.4) ng/ml for the generic and 164 (± 2.5) ng/ml for the innovator groups, p = 0.87. Geometric mean (± SD) day 7 lumefantrine plasma concentration between cured and recurrent malaria was not statistically different in both treatment arms [158.5 (± 2.4) vs 100.0 (± 1.5) ng/ml, (p = 0.28) for generic arm and 158.5 (± 2.3) vs 251.2 (± 4.2) ng/ml, (p = 0.24) for innovator arm]. Nutritional status was found to be a determinant of recurrent malaria (adjusted hazardous ratio (95% confidence interval) = 3(1.1-8.2), p = 0.029.
CONCLUSION


Using the recommended cut-off point of ≥ 200 ng/ml, day 7 plasma lumefantrine concentration failed to predict malaria treatment outcome in children treated with ALu in Tanzania. Further studies are recommended to establish the day 7 plasma lumefantrine concentration cut-off point to predict malaria treatment outcome in children.",2020,"Nutritional status was found to be a determinant of recurrent malaria (adjusted hazardous ratio (95% confidence interval) = 3(1.1-8.2), p = 0.029.
","['children treated with ALu in Tanzania', 'children', 'under-fives children treated with generic or innovator drug-containing artemether-lumefantrine (ALu) in Tanzania', 'children with recurrent malaria', 'under-fives children treated with artemether-lumefantrine in Tanzania', 'Children with uncomplicated malaria aged 6-59\xa0months']","['ALu', ""generic or innovator's product"", 'generic ALu (Artefan ® ']","['Geometric mean (±\u2009SD) day\xa07 lumefantrine plasma concentration between cured and recurrent malaria', 'PCR corrected cure rates', 'geometric mean (±\u2009SD) of day\xa07 plasma lumefantrine concentration', 'recurrent malaria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0936150', 'cui_str': 'artemether / lumefantrine'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0531104', 'cui_str': 'lumefantrine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",,0.207134,"Nutritional status was found to be a determinant of recurrent malaria (adjusted hazardous ratio (95% confidence interval) = 3(1.1-8.2), p = 0.029.
","[{'ForeName': 'Manase', 'Initials': 'M', 'LastName': 'Kilonzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania. manasekilonzi@yahoo.com.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Ritah', 'Initials': 'R', 'LastName': 'Mutagonda', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Baraka', 'Affiliation': 'Department of Research, National Institute of Medical Research, Tanga Centre, P O Box 5004, Tanga, Tanzania.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Sasi', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Muhimbili University of Health and Allied Sciences, P. O. BOX 6515, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Aklillu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital-Huddinge, C1:68, SE-141 86, Stockholm, Sweden.'}, {'ForeName': 'Appolinary', 'Initials': 'A', 'LastName': 'Kamuhabwa', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. BOX 65013, Dar es Salaam, Tanzania.'}]",Malaria journal,['10.1186/s12936-020-3150-y']
3550,32050044,Efficacy and acceptability of self-monitoring via a smartphone application versus traditional paper records in an intensive outpatient eating disorder treatment setting.,"OBJECTIVE


Although self-monitoring is an important part of eating disorder treatment, non-adherence is commonly observed among patients asked to maintain paper food records. This study aims to compare the efficacy and acceptability of electronic self-monitoring via Recovery Record to self-monitoring via traditional paper records, in an intensive outpatient (IOP) eating disorder treatment for adults.
METHOD


Ninety patients were recruited from an IOP eating disorder clinic and randomly assigned to the experimental or control condition. Those in the control condition received the standard treatment delivered by the IOP programme, including the use of paper records for self-monitoring. Those in the experimental condition received the same treatment but used Recovery Record for self-monitoring.
RESULTS


The results did not demonstrate statistically significant group differences over time on eating disorder symptomatology, and there were no statistically significant group differences on acceptability or adherence.
CONCLUSIONS


Our pilot efficacy data do not support superiority of the app over paper records in an IOP setting, so proceeding to a larger efficacy trial is not warranted. Future studies should aim to determine whether the app is efficacious as an adjunct to less intensive treatment or to further explore adherence and acceptability outcomes in studies with larger sample sizes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02484794.",2020,"The results did not demonstrate statistically significant group differences over time on eating disorder symptomatology, and there were no statistically significant group differences on acceptability or adherence.
","['intensive outpatient (IOP) eating disorder treatment for adults', 'Ninety patients were recruited from an IOP eating disorder clinic', 'intensive outpatient eating disorder treatment setting']","['self-monitoring via a smartphone application', 'electronic self-monitoring via Recovery Record to self-monitoring via traditional paper records']","['acceptability or adherence', 'eating disorder symptomatology']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3839717', 'cui_str': 'Eating disorder clinic'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1562582', 'cui_str': 'PACU record'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]",90.0,0.0616803,"The results did not demonstrate statistically significant group differences over time on eating disorder symptomatology, and there were no statistically significant group differences on acceptability or adherence.
","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Keshen', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Helson', 'Affiliation': 'Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Sarrah', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dixon', 'Affiliation': 'Eating Disorder Program, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Tregarthen', 'Affiliation': 'Recovery Record Inc., San Francisco, CA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Town', 'Affiliation': 'Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2727']
3551,32067633,Biannual Treatment of Preschool Children with Single Dose Azithromycin to Reduce Mortality: Impact on Azithromycin Resistance in the MORDOR Trial in Tanzania.,"The  Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance  study showed that administration of biannual, single-dose azithromycin to preschool children reduces mortality. We sought to evaluate its impact on azithromycin resistance. Thirty randomly selected communities in Kilosa district, Tanzania, were randomized to receive 6-monthly single-dose azithromycin (∼20 mg/kg) versus placebo treatment of children aged 1-59 months. From each community, 40 children (aged 1-59 months) were randomly selected at baseline, 12 and 24 months. Isolation and resistance testing of  Streptococcus pneumoniae  and  Escherichia coli  were evaluated using nasopharyngeal and rectal swabs, respectively. The carriage prevalence and the proportion of azithromycin-resistant isolates were determined using disk diffusion. At baseline, the characteristics of the randomly selected children were similar by treatment arms. Both at baseline and in annual cross-sectional surveys, rates of  S. pneumoniae  and  E. coli  isolation between treatment arms were similar. The proportions of azithromycin-resistant  S. pneumoniae  isolates in the children in communities treated with azithromycin versus placebo at baseline, 12 months, and 24 months were 26.5% (18.1%;  P  = 0.26), 26.8% (16.5%;  P  = 0.29), and 13.4% (17.0%;  P  = 0.57), respectively. The proportions of azithromycin-resistant  E. coli  isolates at baseline, 12 months, and 24 months in the azithromycin (versus placebo) arms were 14.9% (18.9%;  P  = 0.16), 21.5% (16.6%;  P  = 0.10), and 14.9% (14.7%;  P  = 0.95), respectively. Over the 24 months, the mean treatment coverage for the azithromycin and placebo was 76.9% and 74.8%, respectively ( P  = 0.49). Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.",2020,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"['Thirty randomly selected communities in Kilosa district, Tanzania', '40 children (aged 1-59 months', 'Preschool Children with Single Dose']","['placebo', 'azithromycin', 'Azithromycin', 'azithromycin versus placebo']","['mean treatment coverage', 'rates of  S. pneumoniae  and  E. coli  isolation', 'Mortality', 'mortality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",30.0,0.109285,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Coles', 'Affiliation': 'Infectious Disease Clinical Research Program, Uniformed University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Mabula', 'Initials': 'M', 'LastName': 'Kasubi', 'Affiliation': 'Department of Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0086']
3552,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3553,31359373,The Effect of an Educational Intervention Based on PRECEDE Model on Oral Cancer Prevention Behaviors in Hookah Users.,"Educational intervention about oral cancer prevention is essential for all people, especially in hookah users. The aim of this study is investigating the effect of an educational intervention based on PRECEDE model on oral cancer prevention in hookah users living in Fasa, Fars Province, Iran, in 2017-2018. In this quasi-experimental study, 360 hookah users were selected and divided into experimental and control groups (180 subjects for each group). Educational intervention was performed for experimental group in 12 sessions. A questionnaire consisting of items evaluating demographic information and PRECEDE model constructs (knowledge, attitude, self-efficacy, enabling factors, and reinforcing factors) was used to measure oral cancer prevention behaviors and nicotine dependency of subjects before and 6 months after intervention. Obtained data were analyzed by SPSS-22 software through paired t test, independent t test, and chi-square test at significance level of P < 0.05. Six months after intervention, experimental group showed significant increase in knowledge, attitude, self-efficacy, enabling factors, reinforcing factors, oral cancer prevention behaviors, and reduction of nicotine dependency compared with control group. This study showed the efficiency of educational intervention based on PRECEDE model in adoption of oral cancer prevention behaviors and reduction of nicotine dependency of hookah users 6 months after intervention.",2020,"Six months after intervention, experimental group showed significant increase in knowledge, attitude, self-efficacy, enabling factors, reinforcing factors, oral cancer prevention behaviors, and reduction of nicotine dependency compared with control group.","['hookah users living in Fasa, Fars Province, Iran, in 2017-2018', 'Hookah Users', '360 hookah users were selected and divided into experimental and control groups (180 subjects for each group']","['educational intervention', 'Educational intervention', 'Educational Intervention']","['knowledge, attitude, self-efficacy, enabling factors, reinforcing factors, oral cancer prevention behaviors, and reduction of nicotine dependency']","[{'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0014024', 'cui_str': 'Enabling Factors'}, {'cui': 'C0035011', 'cui_str': 'Reinforcing Factors'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]",180.0,0.0128012,"Six months after intervention, experimental group showed significant increase in knowledge, attitude, self-efficacy, enabling factors, reinforcing factors, oral cancer prevention behaviors, and reduction of nicotine dependency compared with control group.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khani Jeihooni', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran. Khani_1512@yahoo.com.'}, {'ForeName': 'Pooyan', 'Initials': 'P', 'LastName': 'Afzali Harsini', 'Affiliation': 'Department of Public Health, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01591-6']
3554,32067628,Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger.,"The relationship between malaria and malnutrition is complicated, and existence of one may predispose or exacerbate the other. We evaluated the relationship between malaria parasitemia and nutritional status in children living in communities participating in a cluster-randomized trial of biannual azithromycin compared with placebo for prevention of childhood mortality. Data were collected during the low malaria transmission and low food insecurity season. Parasitemia was not associated with weight-for-height  Z -score (24 months:  P  = 0.11 azithromycin communities,  P  = 0.75 placebo communities), weight-for-age  Z -score (24 months:  P  = 0.83 azithromycin,  P  = 0.78 placebo), height-for-age  Z -score (24 months:  P  = 0.30 azithromycin,  P  = 0.87 placebo), or mid-upper arm circumference (24 months:  P  = 0.12 azithromycin,  P  = 0.56 placebo). There was no statistically significant evidence of a difference in the relationship in communities receiving azithromycin or placebo. During the low transmission season, there was no evidence that malaria parasitemia and impaired nutritional status co-occur in children.",2020,Parasitemia was not associated with weight-for-height  Z -score,"['children living in communities participating in a cluster-randomized trial of', 'Preschool Children in Niger']","['placebo', 'biannual azithromycin', 'azithromycin']","['Malaria Parasitemia and Nutritional Status', 'height-for-age  Z', 'weight-for-age  Z -score', 'Parasitemia', 'malaria parasitemia and nutritional status', 'childhood mortality', 'malaria parasitemia', 'score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0869806,Parasitemia was not associated with weight-for-height  Z -score,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Salissou', 'Initials': 'S', 'LastName': 'Kane', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': 'For The Mordor Study Group', 'Affiliation': ''}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0547']
3555,31705581,Analgesic efficacy of 10% lidocaine spray during nasoenteral catheterization: Randomized triple-blind trial.,"BACKGROUND


Pain is a common experience during nasoenteral catheterization. Although the procedure causes discomfort and distress to patients, procedural pain remains neglected and undertreated.
OBJECTIVE


To evaluate the analgesic efficacy of the use of 10% lidocaine spray during nasoenteral catheterization.
METHOD


A randomized, triple-blind trial of 50 patients was performed. The patients were randomly assigned to two groups: an intervention group (IG), in which 10% lidocaine spray combined with 2% lidocaine gel was used, and a control group (CG), in which a saline solution spray combined with 2% lidocaine gel was used. Pain and discomfort were assessed during and after nasoenteral catheterization using numerical rating scale (NRS) and the visual analogue scale (VAS), respectively.
RESULTS


Intervention group participants reported lower pain scores during (0.20 ± 0.71 vs. 5.00 ± 2.84, p < .001; |d| = -0.677) and after (0.00 ± 0.00 vs. 2.80 ± 2.83, p < .001; |d| = -0.718) nasoenteral catheterization compared to the CG.
CONCLUSION


Spraying 10% lidocaine spray before nasoenteral catheterization was most effective for relieving discomfort and pain, with lower pain and discomfort recorded in NRS and VAS. Topical administration of 10% lidocaine spray is therefore a suggested measure for procedural pain relief related to nasoenteral catheterization.
SIGNIFICANCE


The use of 10% lidocaine spray was more effective in relieving procedural pain and discomfort during nasoenteral catheterization. Patients who received 10% lidocaine spray registered lower discomfort and pain scores than those from 2% lidocaine gel group; there were less complications among patients in the IG.",2020,Patients who received 10% lidocaine spray registered lower discomfort and pain scores than those from 2% lidocaine gel group; there were less complications among patients in the IG.,"['50 patients was performed', 'nasoenteral catheterization']","['lidocaine gel', 'lidocaine spray combined with 2% lidocaine gel', 'lidocaine', 'saline solution spray combined with 2% lidocaine gel', 'lidocaine spray', 'Intervention Group (IG']","['analgesic efficacy', 'procedural pain relief', 'relieving procedural pain and discomfort', 'Analgesic efficacy', 'discomfort and pain scores', 'relieving discomfort and pain, with lower pain and discomfort', 'lower pain scores', 'Pain and discomfort', 'Numerical Rating Scale (NRS) and the Visual Analog Scale (VAS), respectively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C1301771', 'cui_str': 'Relieved'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",50.0,0.179364,Patients who received 10% lidocaine spray registered lower discomfort and pain scores than those from 2% lidocaine gel group; there were less complications among patients in the IG.,"[{'ForeName': 'Amanda Santos', 'Initials': 'AS', 'LastName': 'de Oliveira', 'Affiliation': 'Postgraduate Program in Health Sciences, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Caíque Jordan Nunes', 'Initials': 'CJN', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Health Sciences, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Aline Láyra Carvalho', 'Initials': 'ALC', 'LastName': 'Oliveira', 'Affiliation': 'Department of Nursing, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Viviane Oliveira de Sousa', 'Initials': 'VOS', 'LastName': 'Correia', 'Affiliation': 'Department of Nursing, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Jonas Santana', 'Initials': 'JS', 'LastName': 'Pinto', 'Affiliation': 'Department of Nursing, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Evando', 'Initials': 'E', 'LastName': 'Santos-Júnior', 'Affiliation': 'Department of Medicine, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Maria do Carmo de Oliveira', 'Initials': 'MDCO', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Health Sciences, Federal University of Sergipe, Aracaju, Brazil.'}]","European journal of pain (London, England)",['10.1002/ejp.1503']
3556,32011181,"Acute Effects of Caffeine on Dynamic Accommodative Response and Pupil Size: A Placebo-controlled, Double-blind, Balanced Crossover Study.","OBJECTIVES


To evaluate the acute effect of caffeine consumption on the accuracy and variability of accommodation, as well as its impact on pupil size and perceived levels of activation.
METHODS


22 university students (21.68 ± 3.67 years old) ingested a capsule of caffeine (4 mg/kg) or placebo (300 mg of corn-starch) in two different days and counterbalanced order. After 30 min of capsule ingestion, we objectively measured the accuracy and variability of accommodation, and pupil size using the WAM-5500 binocular open-field autorefractometer for 2 min at each of the six viewing distances (5 m, 50 cm, 40 cm, 33 cm, 25 cm, and 20 cm). Subjective levels of activation to check the effectiveness of caffeine/placebo manipulation were also reported.
RESULTS


We found that after 30 min of caffeine/placebo ingestion, participant perceived higher levels of activation in the caffeine condition ( p  = .047, Cohen´s d = 0.48). Caffeine consumption induced a statistically significant dilator effect on pupil size ( p  = .011, η 2  = 0.271), and reduced variability of accommodative response ( p  = .027, η 2  = 0.211). However, no differences were obtained for the accuracy of accommodation ( p  = .321).
CONCLUSIONS


Our data suggest that caffeine consumption reduced the variability of accommodative response and induced pupil dilation. Nevertheless, the accuracy of accommodation was insensitive to caffeine intake. These findings may be explained by the bidirectional relationship between ocular functioning and the nervous system´s state of activation.",2020,"Caffeine consumption induced a statistically significant dilator effect on pupil size (p = 0.011, η 2  = 0.271), and reduced variability of accommodative response (p = 0.027, η 2  = 0.211).",['Methods : 22 university students (21.68 ± 3.67 years old'],"['caffeine consumption', 'caffeine/placebo', 'caffeine', 'placebo', 'ingested a capsule of caffeine']","['pupil size and perceived levels of activation', 'accuracy of accommodation', 'dynamic accommodative response and pupil size', 'variability of accommodative response and induced pupil dilation', 'levels of activation', 'accuracy and variability of accommodation, and pupil size using the WAM-5500 binocular open-field autorefractometer', 'dilator effect on pupil size', 'variability of accommodative response']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response (observable entity)'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.187649,"Caffeine consumption induced a statistically significant dilator effect on pupil size (p = 0.011, η 2  = 0.271), and reduced variability of accommodative response (p = 0.027, η 2  = 0.211).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Redondo', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Vera', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Carreño-Rodríguez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Molina-Romero', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}, {'ForeName': 'Raimundo', 'Initials': 'R', 'LastName': 'Jiménez', 'Affiliation': 'Department of Optics, Faculty of Sciences, University of Granada , Granada, Spain.'}]",Current eye research,['10.1080/02713683.2020.1725060']
3557,32048379,Effects of continuous positive airway pressure treatment on aortic stiffness in patients with resistant hypertension and obstructive sleep apnea: A randomized controlled trial.,"Resistant hypertension (RHT) is associated with obstructive sleep apnea (OSA) and increased aortic stiffness, measured by carotid-femoral pulse wave velocity (cf-PWV). We aimed to evaluate in a randomized controlled trial, the effect of Continuous positive airway pressure (CPAP) treatment on cf-PWV in comparison with a control group in patients with RHT and moderate-severe OSA. One-hundred and sixteen patients were randomized to 6-month CPAP treatment (56 patients) or no therapy (60 patients), while keeping their antihypertensive treatment unchanged. Carotid-femoral pulse wave velocity was performed at the beginning and end of the 6-month period. Intention-to-treat intergroup differences in cf-PWV changes were assessed by a generalized mixed-effects model with the allocation group as a fixed factor and adjusted for age, sex, changes in mean arterial pressure and the baseline cf-PWV values. Subgroup sensitivity analyses were performed, excluding patients with low CPAP adherence and low cf-PWV at baseline. CPAP and control groups had similar clinic-laboratorial characteristics. Patients had a mean cf-PWV of 9.4 ± 1.6 m/s and 33% presented cf-PWV > 10 m/s. During treatment, the control group had a mean increase in cf-PWV of +0.43 m/s (95% confidence interval [CI], +0.14 to +0.73 m/s; p = .005), whereas the CPAP group had a mean increase of +0.03 m/s (95% CI, -0.33 to +0.39 m/s; p = .87), resulting in a mean difference in changes between CPAP and control of -0.40 m/s (95% CI, -0.82 to +0.02 m/s; p = .059). Subgroup analyses did not change the results. In conclusion, a 6-month CPAP treatment did not reduce aortic stiffness, measured by cf-PWV, in patients with RHT and moderate/severe OSA, but treatment may prevent its progression, in contrast to no-CPAP therapy.",2020,"During treatment, the control group had a mean increase in cf-PWV of +0.43 m/s (95% confidence interval [CI], +0.14 to +0.73 m/s; p = .005), whereas the CPAP group had a mean increase of +0.03 m/s (95% CI, -0.33 to +0.39 m/s; p = .87), resulting in a mean difference in changes between CPAP and control of -0.40 m/s (95% CI, -0.82 to +0.02 m","['One-hundred and sixteen patients', 'Patients had a mean cf-PWV of 9.4\xa0±', 'patients with resistant hypertension and obstructive sleep apnea', 'patients with RHT and moderate-severe OSA']","['Continuous positive airway pressure (CPAP', 'CPAP', 'continuous positive airway pressure treatment', 'CPAP treatment (56 patients) or no therapy']","['obstructive sleep apnea (OSA) and increased aortic stiffness', 'aortic stiffness', 'mean increase in cf-PWV']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",116.0,0.178654,"During treatment, the control group had a mean increase in cf-PWV of +0.43 m/s (95% confidence interval [CI], +0.14 to +0.73 m/s; p = .005), whereas the CPAP group had a mean increase of +0.03 m/s (95% CI, -0.33 to +0.39 m/s; p = .87), resulting in a mean difference in changes between CPAP and control of -0.40 m/s (95% CI, -0.82 to +0.02 m","[{'ForeName': 'Claudia R L', 'Initials': 'CRL', 'LastName': 'Cardoso', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil.'}, {'ForeName': 'Christian N', 'Initials': 'CN', 'LastName': 'Roderjan', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil.'}, {'ForeName': 'Aline H', 'Initials': 'AH', 'LastName': 'Cavalcanti', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Cortez', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Muxfeldt', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil.'}, {'ForeName': 'Gil F', 'Initials': 'GF', 'LastName': 'Salles', 'Affiliation': 'Department of Internal Medicine, School of Medicine, University Hospital Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil.'}]",Journal of sleep research,['10.1111/jsr.12990']
3558,31912268,Results of the double-blind randomized controlled trial comparing laser hemorrhoidoplasty with sutured mucopexy and excisional hemorrhoidectomy.,"PURPOSE


To compare the results of laser hemorrhoidoplasty (LHP), excisional hemorrhoidectomy (EH), and sutured mucopexy (MP).
METHODS


A randomized, parallel-group, double-blinded, single-center prospective study.
PATIENTS


Symptomatic 2nd- or 3rd-degree hemorrhoids patients.
INTERVENTIONS


Computer randomization sequence, patient blinding, operating surgeon blinding, and surgeon-evaluator blinding. LHP was performed using a 1470 nm diode laser. Up to 250 J of energy delivered per 1 hemorrhoid. The procedure was performed circumferentially. MP ligations were placed in the area of visible hemorrhoidal tissue. Standard EH was performed up to the level of the hemorrhoidal pedicle. Follow-up at 1 and 6 weeks and 1 year.
OUTCOME MEASURES


Recurrence of symptoms requiring treatment, intensity, and duration of pain after the operation, patients' quality of life, fecal incontinence, and patients' evaluation of treatment.
RESULTS


A total of 121 patients. Groups were even preoperatively. LHP took 15 min (SD 5.6), MP took 16 min (SD 5.58), and EH took 29 min (SD 10.3). Recurrence requiring treatment rate was 0% after EH, 10% after LHP, and 22% after MP, p = 0.004. LHP and MP were less painful than EH, p < 0.001. Patients after LHP returned to regular activity after 15 days, after MP after 22 days, and after EH after 30 days, p < 0.001. SF-36 scores were better after EH. Symptoms of fecal incontinence improved in all the groups. Patients evaluate LHP better than EH and MP.
LIMITATIONS


Single-center study.
CONCLUSIONS


Laser hemorrhoidoplasty is a safe, minimally invasive option for hemorrhoids, more effective than MP and less effective than EH. Patients evaluate this technique better than the other two.",2020,"Recurrence requiring treatment rate was 0% after EH, 10% after LHP, and 22% after MP, p = 0.004.","['Symptomatic 2nd- or 3rd-degree hemorrhoids patients', 'A total of 121 patients']","['LHP', 'Laser hemorrhoidoplasty', 'laser hemorrhoidoplasty (LHP), excisional hemorrhoidectomy (EH), and sutured mucopexy (MP', 'laser hemorrhoidoplasty with sutured mucopexy and excisional hemorrhoidectomy']","['Recurrence requiring treatment rate', 'regular activity', 'SF-36 scores', ""Recurrence of symptoms requiring treatment, intensity, and duration of pain after the operation, patients' quality of life, fecal incontinence, and patients' evaluation of treatment"", 'Symptoms of fecal incontinence', 'LHP and MP']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",121.0,0.158391,"Recurrence requiring treatment rate was 0% after EH, 10% after LHP, and 22% after MP, p = 0.004.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Poskus', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania. toshcus@yahoo.com.'}, {'ForeName': 'Donatas', 'Initials': 'D', 'LastName': 'Danys', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Gabija', 'Initials': 'G', 'LastName': 'Makunaite', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Antanas', 'Initials': 'A', 'LastName': 'Mainelis', 'Affiliation': 'Center of Abdominal Surgery, Vilnius University Hospital Santara Clinics, Santariskiu Street, LT-08661, Vilnius, Lithuania.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Mikalauskas', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Eligijus', 'Initials': 'E', 'LastName': 'Poskus', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Valdemaras', 'Initials': 'V', 'LastName': 'Jotautas', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Dulskas', 'Affiliation': 'National Cancer Institute, Vilnius, Lithuania.'}, {'ForeName': 'Eugenijus', 'Initials': 'E', 'LastName': 'Jasiunas', 'Affiliation': 'Center of Abdominal Surgery, Vilnius University Hospital Santara Clinics, Santariskiu Street, LT-08661, Vilnius, Lithuania.'}, {'ForeName': 'Kestutis', 'Initials': 'K', 'LastName': 'Strupas', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}]",International journal of colorectal disease,['10.1007/s00384-019-03460-6']
3559,31873765,"Safety, pharmacokinetic and pharmacodynamic properties of single ascending dose and continuous infusion of remimazolam besylate in healthy Chinese volunteers.","PURPOSE


The aim of the present study was to evaluate the safety, pharmacokinetic (PK) and pharmacodynamic (PD) properties of remimazolam besylate following single ascending dose (SAD) and continuous infusion in healthy Chinese volunteers.
METHODS


This was a randomized phase I study conducted in two parts. Part I was a double-blind, placebo- and midazolam-controlled, SAD study among healthy Chinese participants with a remimazolam dose of 0.025-0.4 mg/kg. Part II was an open-label, midazolam-controlled, continuous infusion study. Bispectral index (BIS) monitoring and Modified Observers Assessment of Alertness and Sedation (MOAA/S) score assessment were used to assess the PD properties.
RESULTS


The half-life range of remimazolam was from 34.1 ± 8.1 to 59.8 ± 20.5 min in the SAD study. The sedation function was initially observed at the dose of 0.05 mg/kg remimazolam. Doses of ≥ 0.075 mg/kg exerted a peak sedation effect within 1-2 min after injection, resulting in a deeper and more rapid sedation. In the 2 h continuous infusion, remimazolam showed a deeper sedation and more rapid recovery than midazolam. For general anesthesia, an induction dosage of 0.2 mg/kg/min and a maintenance dosage of 1 mg/kg/h can achieve a satisfactory efficacy effect.
CONCLUSIONS


Remimazolam was safe and well tolerated in healthy Chinese participants. Based on the phase I clinical study, we suggest that remimazolam besylate demonstrates greater sedation and quicker recovery from sedation than midazolam.",2020,"In the 2 h continuous infusion, remimazolam showed a deeper sedation and more rapid recovery than midazolam.","['healthy Chinese volunteers', 'healthy Chinese participants', 'healthy Chinese participants with a remimazolam dose of 0.025-0.4\xa0mg/kg']","['remimazolam besylate', '≥', 'Remimazolam', 'midazolam', 'remimazolam', 'placebo']","['rapid recovery', 'satisfactory efficacy effect', 'sedation function', 'peak sedation effect', 'Bispectral index (BIS) monitoring and Modified Observers Assessment of Alertness and Sedation (MOAA/S) score assessment', 'Safety, pharmacokinetic and pharmacodynamic properties', 'safety, pharmacokinetic (PK) and pharmacodynamic (PD) properties', 'safe and well tolerated']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517400', 'cui_str': 'Zero point zero two five'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",,0.0742346,"In the 2 h continuous infusion, remimazolam showed a deeper sedation and more rapid recovery than midazolam.","[{'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Sheng', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Xue-Yuan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Li-E', 'Initials': 'LE', 'LastName': 'Li', 'Affiliation': 'R&D, Yichang Humanwell Pharmaceutical Co. Ltd., Hubei, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'R&D, Yichang Humanwell Pharmaceutical Co. Ltd., Hubei, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China. cui.pharm@pkufh.com.'}]",European journal of clinical pharmacology,['10.1007/s00228-019-02800-3']
3560,32048017,"Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up.","BACKGROUND


Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion. The purpose of the present study was to investigate the in vivo wear behavior of UHMWPE-XE in comparison with conventional UHMWPE-X liners using virtual CAD-based radiographs.
METHODS


Until now, 94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up. Of these, 51 (54%) received UHMWPE-XE and 43 (46%) UHMWPE-X liners. Anteroposterior pelvic radiographs were made immediately after surgery and at 1 and 5 years postoperatively. The radiographs were analyzed using the observer-independent analysis software RayMatch ®  (Raylytic GmbH, Leipzig, Germany).
RESULTS


The mean wear rate was measured to be 23.6 μm/year (SD 13.7; range 0.7-71.8 μm). There were no significant differences between the two cohorts (UHMWPE-X: 23.2 μm/year vs. UHMWPE-XE: 24.0 μm/year, p = 0.73). Cup anteversion significantly changed within the 1st year after implantation independent from the type of polyethylene liner [UHMWPE-X: 18.2-23.9° (p = 0.0001); UHMWPE-XE: 21.0-25.5° (p = 0.002)]. No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)].
CONCLUSION


The present study demonstrates that the addition of vitamin E does not adversely affect the midterm wear behavior of UHMWPE-X. The antioxidative benefit of vitamin E is expected to become evident in long-term follow-up. Cup anteversion increment by 5° within the 1st year is likely a result of the released hip flexion contracture resulting in an enhanced posterior pelvic tilt. Therefore, a reassessment of target values in acetabular cup placement might be considered.",2020,"No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)].
","['94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up', 'total hip arthroplasty']","['vitamin E', 'conventional UHMWPE-X liners', 'Vitamin E-blended highly cross-linked polyethylene liners', 'Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE', 'UHMWPE-XE']","['mean wear rate', 'midterm wear behavior of UHMWPE-X', 'Cup anteversion increment', 'Cup anteversion', 'cup anteversion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0673477', 'cui_str': 'UHMWPE'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0969677', 'cui_str': 'd-alpha tocopherol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0673477', 'cui_str': 'UHMWPE'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0333053', 'cui_str': 'Anteversion (morphologic abnormality)'}]",94.0,0.0571781,"No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)].
","[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Busch', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery Marienhospital Mülheim an der Ruhr, Chair of Orthopaedics and Trauma Surgery University of Duisburg-Essen, Essen, Germany. andre.busch@uk-essen.de.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jäger', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery Marienhospital Mülheim an der Ruhr, Chair of Orthopaedics and Trauma Surgery University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klebingat', 'Affiliation': 'Institut für Medizintechnik und Forschungscampus STIMULATE, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Baghdadi', 'Affiliation': 'Department of Orthopaedic Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Flörkemeier', 'Affiliation': 'Department für Orthopädie, Unfall- und Wiederherstellungschirurgie, Universitätsklinikum Halle (Saale), Ernst-Grube-Str. 40, 06114, Halle (Saale), Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hütter', 'Affiliation': 'Department of Orthopaedics and Trauma Surgery, Elisabeth-Klinikum Olsberg, Olsberg, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Grupp', 'Affiliation': 'Aesculap AG, Research and Development, 78532, Tuttlingen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Haversath', 'Affiliation': 'Department of Orthopaedics, Trauma and Reconstructive Surgery Marienhospital Mülheim an der Ruhr, Chair of Orthopaedics and Trauma Surgery University of Duisburg-Essen, Essen, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03358-x']
3561,31949042,Scheduled afternoon-evening sleep leads to better night shift performance in older adults.,"OBJECTIVES


This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults.
METHODS


Non-shift workers aged 57.9±4.6 (mean±SD) worked four day (07:00-15:00) and four night shifts (23:00-07:00). Two intervention groups were instructed to remain awake until ~13:00 after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8 hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions. A control group (n=9) from our previous study was not given any sleep instructions. Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance.
RESULTS


The ST group maintained their day shift sleep durations on night shifts, whereas the control group slept less. The ST group were able to maintain stable performance and alertness across the initial part of the night shift, while the control group's alertness and performance declined across the entire night. Wake duration before a night shift negatively impacted sustained attention and self-reported sleepiness but not reaction time, whereas sleep duration before a night shift affected reaction time and ability to sustain attention but not self-reported sleepiness.
CONCLUSIONS


A behavioural change under the control of the individual worker, spending 8 hours in bed and waking close to the start of the night shift, allowed participants to acquire more sleep and improved performance on the night shift in older adults. Both sleep duration and timing are important factors for night shift performance and self-reported sleepiness.",2020,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults.
","['Non-shift workers aged 57.9±4.6 (mean±SD) worked four\u2009day (07:00-15:00) and four night shifts (23:00-07:00', 'older adults']","['remain awake until ~13:00\u2009after each night shift: the sleep timing group (ST; n=9) was instructed to spend 8\u2009hours in bed attempting sleep, and the sleep ad-lib group (n=9) was given no further sleep instructions']","['homeostatic sleep pressure', 'Hourly Karolinska Sleepiness Scales and Psychomotor Vigilance Tasks assessed subjective sleepiness and performance']","[{'cui': 'C0425104', 'cui_str': 'Shift worker (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.00963091,"This study investigated whether an intervention designed to reduce homeostatic sleep pressure would improve night shift performance and alertness in older adults.
","[{'ForeName': 'Cheryl Martine', 'Initials': 'CM', 'LastName': 'Isherwood', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Chinoy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Audra S', 'Initials': 'AS', 'LastName': 'Murphy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jeanne F', 'Initials': 'JF', 'LastName': 'Duffy', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA jduffy@research.bwh.harvard.edu.""}]",Occupational and environmental medicine,['10.1136/oemed-2019-105916']
3562,32048134,Chest CT screening in patients with overweight or obesity using spectral shaping at 150 kVp: compared with 120 kVp protocol and spectral shaping at 100 kVp protocol.,"PURPOSE


To evaluate the image quality (IQ) and the figure of merit (FoM) of chest CT screening in patients with overweight or obesity using a tin filter for spectral shaping at 150 kVp.
MATERIALS AND METHODS


Patients with overweight or obesity (N = 150, body mass index ≥ 26 kg/m 2 ) with indications for chest CT screening were prospectively enrolled and randomly divided into three groups: 120 kVp group (standard radiation dose/tube voltage, 120 kVp/CT volume does index, 4.68 mGy); Sn100 kVp group (1/10th radiation dose level/100 kVp with a tin filter/0.47 mGy); Sn150 kVp group (1/2th radiation dose level/150 kVp with a tin filter/2.34 mGy). IQ and FoMs were evaluated and compared among the three groups.
RESULTS


Image noise, signal-to-noise ratios and subjective IQ scores were significantly higher in the Sn150 kVp group than those in the Sn100 kVp group (all p < 0.05), but were not significantly different with those in the 120 kVp group. FoMs in the Sn150 kVp group were significantly higher than those in the 120 kVp group (all p < 0.05), but showed no statistical difference with those in the Sn100 kVp group.
CONCLUSIONS


Compared with scanning at 120 kVp, chest CT screening performed at 150 kVp with spectral shaping substantially reduces the radiation dose in overweight and obese patients while maintaining IQ.",2020,"RESULTS


Image noise, signal-to-noise ratios and subjective IQ scores were significantly higher in the Sn150 kVp group than those in the Sn100 kVp group (all p < 0.05), but were not significantly different with those in the 120 kVp group.","['m 2 ) with indications for\xa0chest CT screening', 'Patients with overweight or obesity', '26\xa0kg', 'patients with overweight or obesity using spectral shaping at 150\xa0kVp', 'patients with overweight or obesity using a tin filter for spectral shaping at 150\xa0kVp']","['Chest CT screening', '120\xa0kVp group (standard radiation dose/tube voltage, 120\xa0kVp/CT volume does index, 4.68\xa0mGy); Sn100\xa0kVp group (1/10th radiation dose level/100\xa0kVp with a tin filter/0.47\xa0mGy); Sn150 kVp group (1/2th radiation dose level/150\xa0kVp with a tin filter/2.34\xa0mGy', 'chest CT screening']","['IQ and FoMs', 'image quality (IQ) and the figure of merit (FoM', 'Image noise, signal-to-noise ratios and subjective IQ scores']","[{'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0202823', 'cui_str': 'Chest CT'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}]","[{'cui': 'C0202823', 'cui_str': 'Chest CT'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3873195', 'cui_str': 'Milligray (qualifier value)'}, {'cui': 'C0040238', 'cui_str': 'Tin'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0105516,"RESULTS


Image noise, signal-to-noise ratios and subjective IQ scores were significantly higher in the Sn150 kVp group than those in the Sn100 kVp group (all p < 0.05), but were not significantly different with those in the 120 kVp group.","[{'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The Second People's Hospital of Shizuishan, NO.246 West Youyi Street, Shizuishan, 753000, Ningxia, China.""}, {'ForeName': 'Zhifeng', 'Initials': 'Z', 'LastName': 'Mai', 'Affiliation': ""Department of Radiology, The Second People's Hospital of Shizuishan, NO.246 West Youyi Street, Shizuishan, 753000, Ningxia, China.""}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, The First People's Hospital of Shizuishan, NO.1 Kangle Road, Shizuishan, 753000, Ningxia, China.""}, {'ForeName': 'Jiamang', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': ""Department of Radiology, The Second People's Hospital of Shizuishan, NO.246 West Youyi Street, Shizuishan, 753000, Ningxia, China.""}, {'ForeName': 'Mingjie', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The Second People's Hospital of Shizuishan, NO.246 West Youyi Street, Shizuishan, 753000, Ningxia, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, The Second People's Hospital of Shizuishan, NO.246 West Youyi Street, Shizuishan, 753000, Ningxia, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, The Second People's Hospital of Shizuishan, NO.246 West Youyi Street, Shizuishan, 753000, Ningxia, China. ljw7122@163.com.""}]",Japanese journal of radiology,['10.1007/s11604-020-00925-5']
3563,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3564,30994376,"Adiposity, Hepatic Triglyceride, and Carotid Intima Media Thickness During Behavioral Weight Loss Treatment in Antipsychotic-Treated Youth: A Randomized Pilot Study.","Objectives:  The purpose of this pilot study was to evaluate changes in adiposity, carotid intima media thickness (CIMT), and hepatic fat content measured via magnetic resonance imaging-estimated hepatic proton density fat fraction (PDFF) in antipsychotic (AP)-treated youth versus nonpsychiatric (NP) participants during participation in a 16-week behavioral weight loss (BWL) intervention.  Subjects/Methods:  Overweight/obese AP-treated youth ( n  = 26) were randomized 2:1 to weekly treatment versus recommended care (RC) over 16 weeks. NP controls ( n  = 21) were assigned to weekly treatment. Dual-energy X-ray absorptiometry (DEXA)-measured adiposity, CIMT, and PDFF were measured at baseline and 16 weeks. Analyses assessed group differences in the effect of BWL on adiposity, CIMT, and PDFF.  Results:  BWL was well tolerated in both AP-treated and NP groups. DEXA-measured fat decreased significantly in the NP group ( F [1,16] = 11.81,  p  = 0.003), with modest improvements in adiposity and hepatic fat in the AP-treated group, while an increase in adiposity was observed in the RC group. Significant differences in endpoint DEXA total fat ( F [2,34] = 4.81,  p  = 0.01) and PDFF ( F [2,30] = 3.60,  p  = 0.04) occurred across treatment groups, explained by larger improvements in NP versus RC youth in DEXA total fat ( p  = 0.03) and PDFF ( p  = 0.04).  Conclusions:  Intensive, family-based BWL treatment can improve whole-body adiposity and liver fat in obese youth, with decreases or attenuation of additional fat gain observed in AP-treated youth.",2019,"Significant differences in endpoint DEXA total fat ( F [2,34] = 4.81,  p  = 0.01) and PDFF ( F [2,30] = 3.60,  p  = 0.04) occurred across treatment groups, explained by larger improvements in NP versus RC youth in DEXA total fat ( p  = 0.03) and PDFF ( p  = 0.04).  ","['Antipsychotic-Treated Youth', 'Overweight/obese AP-treated youth ( n \u2009=\u200926']",['antipsychotic (AP)-treated youth versus nonpsychiatric (NP) participants during participation in a 16-week behavioral weight loss (BWL) intervention'],"['DEXA-measured fat', 'tolerated', 'PDFF', 'Dual-energy X-ray absorptiometry (DEXA)-measured adiposity, CIMT, and PDFF', 'adiposity', 'effect of BWL on adiposity, CIMT, and PDFF', 'adiposity, carotid intima media thickness (CIMT), and hepatic fat content', 'endpoint DEXA total fat', 'adiposity and hepatic fat', 'Adiposity, Hepatic Triglyceride, and Carotid Intima Media Thickness']","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",26.0,0.0372611,"Significant differences in endpoint DEXA total fat ( F [2,34] = 4.81,  p  = 0.01) and PDFF ( F [2,30] = 3.60,  p  = 0.04) occurred across treatment groups, explained by larger improvements in NP versus RC youth in DEXA total fat ( p  = 0.03) and PDFF ( p  = 0.04).  ","[{'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kolko', 'Affiliation': '2Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Department of Psychiatry, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Ricchio', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Schweiger', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': '4Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Wilfley', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': '1Healthy Mind Lab, Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0120']
3565,32058465,Effect of Different Types of Messages on Readiness to Indicate Willingness to Register for Organ Donation During Driver's License Renewal in Japan.,"BACKGROUND


In Japan, a recent opinion poll in 2017 showed that 41.9% of the respondents wished to donate their organs, but only 12.7% declared their intention to donate or not do so. Therefore, it is important to explore measures to prompt more individuals to register their intention about organ donation.
METHODS


A field experimental questionnaire survey was conducted to confirm the effect of a prompt message for registering intentions for organ donation, which was communicated at a driver's license center. The study employed a prospective randomized control design. Seven thousand six hundred fifteen individuals visited the Tokyo Fuchu License Examination Center to update their driver's license and received leaflets including a message prompting organ donation registration and the questionnaire. Of the participants who received leaflets, 3224 respondents provided complete responses to the questionnaire (valid response rate: 42.3%). Subsequently, a questionnaire survey was conducted to assess the participants' willingness to register for organ donation. A control condition and the following types of messages were used: peer-framed, gain-framed, loss-framed, reciprocity-framed, and peer + reciprocity-framed.
RESULTS


The reciprocity message emerged as a significant predictor of increase in immediate decision response. The loss-framed message was a significant predictor of decrease in no intention to register.
CONCLUSIONS


This study found that reciprocity and loss-framed messages promoted the readiness to register for organ donation among individuals from a Japanese urban area. Mandatory distribution of prompt messages at every driver's license centers in Japan would be recommended.",2020,The reciprocity message emerged as a significant predictor of increase in immediate decision response.,"['individuals from a Japanese urban area', ""7615 individuals visited the Tokyo Fuchu License Examination Center to update their driver's license and received leaflets including a message prompting organ donation registration and the questionnaire""]",[],['immediate decision response'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282366', 'cui_str': 'Organ Donation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]",7615.0,0.0468514,The reciprocity message emerged as a significant predictor of increase in immediate decision response.,"[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hirai', 'Affiliation': 'Graduate School of Human Sciences, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Ohtake', 'Affiliation': 'Graduate School of Economics, Osaka University, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Faculty of Medicine, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shusaku', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Graduate School of Economics, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Yamazaki', 'Affiliation': 'Center for the Study of Co* Design, Osaka University, Toyonaka, Osaka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Faculty of Medicine, Saga University, Saga, Japan.'}]",Transplantation,['10.1097/TP.0000000000003181']
3566,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3567,32055016,Phase I/II randomized study of proton beam with anti-VEGF for exudative age-related macular degeneration: long-term results.,"BACKGROUND/OBJECTIVE


To determine if treatment of exudative age-related macular degeneration (eAMD) using proton beam therapy (PBT) combined with intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is safe and effective long term.
SUBJECT/METHODS


Thirty eyes with newly diagnosed eAMD were enrolled in a phase I/II prospective, sham-controlled double-masked university study. Eyes were randomized 1:1:1-24 GyE, 16 GyE or sham radiation, and treated with three initial monthly intravitreal ranibizumab or bevacizumab. Subsequent anti-VEGF reinjection was based on monthly optical coherence tomography and examination for 2 years and standard of care thereafter.
RESULTS


A total of 23 eyes completed 2-year study follow-up, of which 16 maintained monthly follow-up. Mean best-correct visual acuity (BCVA) at 2 years was similar among treatment groups (p > 0.05). The 24 GyE group required fewer anti-VEGF injections when compared with the sham group at 2 years (4.67 ± 1.9 vs 9.67 ± 3.5; p = 0.017). Extended follow-up (mean 4 years) available in 22 eyes showed persistent reduced need for anti-VEGF therapy among eyes treated with 24 GyE compared with sham radiation (2.0 ± 1.6 vs 4.84 ± 2.4 per year, p = 0.008). New and increasing geographic atrophy (GA), noted in some eyes in all treatment groups, resulted in decreased mean BCVA from baseline for the 24 GyE group on extended follow-up (p = 0.009). Possible mild radiation retinopathy noted in 15% of eyes was not visually significant.
CONCLUSIONS


Initial treatment combining PBT (24 GyE) with intravitreal anti-VEGF therapy appears to decrease the need for anti-VEGF reinjection in eyes with newly diagnosed eAMD. Radiation retinopathy risk was low and does not appear visually significant. Long-term vision was limited by GA development especially in the 24 GyE group.",2020,Mean best-correct visual acuity (BCVA) at 2 years was similar among treatment groups (p > 0.05).,"['exudative age-related macular degeneration', 'Thirty eyes with newly diagnosed eAMD', 'A total of 23 eyes completed 2-year study follow-up, of which 16 maintained monthly follow-up', 'exudative age-related macular degeneration (eAMD', 'eyes with newly diagnosed eAMD']","['GyE or sham radiation', 'proton beam with anti-VEGF', 'proton beam therapy (PBT) combined with intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy', 'ranibizumab or bevacizumab', 'intravitreal anti-VEGF therapy']","['fewer anti-VEGF injections', 'Radiation retinopathy risk', 'mild radiation retinopathy', 'mean BCVA', 'Mean best-correct visual acuity (BCVA', 'geographic atrophy (GA']","[{'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0729603', 'cui_str': 'Proton beam (physical force)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0339483', 'cui_str': 'Radiation retinopathy (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}]",30.0,0.039023,Mean best-correct visual acuity (BCVA) at 2 years was similar among treatment groups (p > 0.05).,"[{'ForeName': 'Lekha K', 'Initials': 'LK', 'LastName': 'Mukkamala', 'Affiliation': 'Vitreoretinal Service, Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Mishra', 'Affiliation': 'Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Daftari', 'Affiliation': 'Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Moshiri', 'Affiliation': 'Vitreoretinal Service, Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA.'}, {'ForeName': 'Susanna S', 'Initials': 'SS', 'LastName': 'Park', 'Affiliation': 'Vitreoretinal Service, Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, CA, USA. sscpark@ucdavis.edu.'}]","Eye (London, England)",['10.1038/s41433-020-0807-2']
3568,31676670,Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma.,"PURPOSE


This randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer.
PATIENTS AND METHODS


Second-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months.
RESULTS


A total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively.
CONCLUSIONS


Response rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population.",2020,"Progression-free survival rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively.","['chemotherapy-refractory gastric cancer (GC) or gastroesophageal junction (GEJ) cancer', '113 patients', 'Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma', 'Second-line patients', 'second- and third-line patients receiving the combination (arm E']","['Durvalumab and Tremelimumab Alone', 'durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D', 'durvalumab and tremelimumab in combination or as monotherapy']","['grade 3/4 adverse events', 'objective response rate and progression-free survival rate', 'Overall response rates', 'Safety and Efficacy', 'overall survival rates', 'Progression-free survival rates']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",113.0,0.0825744,"Progression-free survival rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively.","[{'ForeName': 'Ronan J', 'Initials': 'RJ', 'LastName': 'Kelly', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Ronan.Kelly@BSWHealth.org.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Khaldoun', 'Initials': 'K', 'LastName': 'Almhanna', 'Affiliation': 'Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Blum-Murphy', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Daniel V T', 'Initials': 'DVT', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Gibson', 'Affiliation': 'Division of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Cheng Ean', 'Initials': 'CE', 'LastName': 'Chee', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Rom', 'Initials': 'R', 'LastName': 'Leidner', 'Affiliation': 'Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Providence Portland Medical Center, Providence Cancer Institute, Portland, Oregon.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Marlon C', 'Initials': 'MC', 'LastName': 'Rebelatto', 'Affiliation': 'Oncology Translational Medicine, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Philip Z', 'Initials': 'PZ', 'LastName': 'Brohawn', 'Affiliation': 'Oncology Translational Medicine, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'Early Oncology Statistics, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDevitt', 'Affiliation': 'Early Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sheth', 'Affiliation': 'Early Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Judson M', 'Initials': 'JM', 'LastName': 'Englert', 'Affiliation': 'Early Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Geoffrey Y', 'Initials': 'GY', 'LastName': 'Ku', 'Affiliation': 'Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2443']
3569,31406274,Differences in exposure to toxic and/or carcinogenic volatile organic compounds between Black and White cigarette smokers.,"OBJECTIVE


It is unclear why Black smokers in the United States have elevated risk of some tobacco-related diseases compared to White smokers. One possible causal mechanism is differential intake of tobacco toxicants, but results across studies are inconsistent. Thus, we examined racial differences in biomarkers of toxic volatile organic compounds (VOCs) present in tobacco smoke.
METHOD


We analyzed baseline data collected from 182 Black and 184 White adult smokers who participated in a randomized clinical trial in 2013-2014 at 10 sites across the United States. We examined differences in urinary levels of ten VOC metabolites, total nicotine equivalents (TNE), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), controlling for covariates such as cigarettes per day (CPD), as well as differences in VOCs per TNE to assess the extent to which tobacco exposure, and not metabolic factors, accounted for racial differences.
RESULTS


Concentration of metabolites of acrolein, acrylonitrile, ethylene oxide, and methylating agents were significantly higher in Blacks compared to Whites when controlled for covariates. Other than the metabolite of methylating agents, VOCs per TNE did not differ between Blacks and Whites. Concentrations of TNE/CPD and VOCs/CPD were significantly higher in Blacks. Menthol did not contribute to racial differences in VOC levels.
CONCLUSIONS


For a given level of CPD, Black smokers likely take in higher levels of acrolein, acrylonitrile, and ethylene oxide than White smokers. Our findings are consistent with Blacks taking in more nicotine and toxicants per cigarette smoked, which may explain their elevated disease risk relative to other racial groups.",2019,Concentrations of TNE/CPD and VOCs,"['182 Black and 184 White adult smokers who participated in a randomized clinical trial in 2013-2014 at 10 sites across the United States', 'Black smokers', 'Black and White cigarette smokers']",['Menthol'],"['urinary levels of ten VOC metabolites, total nicotine equivalents (TNE), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), controlling for covariates such as cigarettes per day (CPD', 'Concentrations of TNE/CPD and VOCs', 'Concentration of metabolites of acrolein, acrylonitrile, ethylene oxide, and methylating agents', 'CPD']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001204', 'cui_str': 'Acraldehyde'}, {'cui': 'C0001223', 'cui_str': 'Vinyl Cyanide'}, {'cui': 'C0015087', 'cui_str': 'Ethylene Oxide'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",,0.0263075,Concentrations of TNE/CPD and VOCs,"[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA. Gideon.Sthelen@ucsf.edu.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gregorich', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Eliseo J', 'Initials': 'EJ', 'LastName': 'Pérez-Stable', 'Affiliation': 'Division of Intramural Research, National Heart, Lung and Blood Institute and Office of the Director, National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Journal of exposure science & environmental epidemiology,['10.1038/s41370-019-0159-9']
3570,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3571,32052432,A randomized controlled trial on the impact of healing time on wound healing following ridge preservation using a 70%/30% combination of mineralized and demineralized freeze-dried bone allograft.,"BACKGROUND


To compare the histologic difference in healing between ridge preservation sites treated with a combination allograft of 70% mineralized and 30% demineralized freeze-dried bone allograft (FDBA) evaluated at 8 to 10 weeks versus 18 to 20 weeks post-extraction. Changes in morphological ridge dimensions were also evaluated.
METHODS


Forty-four patients with a single-rooted tooth to be extracted and replaced by a dental implant were recruited for this study. At time of extraction, measurements were taken with a custom acrylic stent, and the extraction socket was grafted with the combination allograft and covered with a nonresorbable membrane. Patients were randomly assigned to the short-term (8 to 10 weeks) or long-term (18 to 20 weeks) healing group. Sites were re-entered for study measurements, a bone core sample, and implant placement. Bone cores obtained during implant placement were analyzed histologically to determine percentages of vital bone, residual graft, and CT/other.
RESULTS


Thirty-eight of the 44 patients completed the study, 19 in each group. There was a significant difference between the two groups for mean percent vital bone formation (short-term = 18.17%, long-term = 40.32%, P = < 0.0001) and percentage of residual graft (short-term = 41.54%, long-term = 23.59%, P = < 0.0001). There was no difference in morphological changes between the two groups.
CONCLUSION


Ridge preservation using combination FDBA resulted in approximately twice as much vital bone and half as much residual graft material after 18 to 20 weeks of healing compared to only 8 to 10 weeks healing.",2020,"There was a significant difference between the two groups for mean percent vital bone formation (short-term = 18.17%, long-term = 40.32%, p = <.0001) and percentage of residual graft (short-term = 41.54%, long-term = 23.59%, p = <.0001).","['Thirty-eight of the 44 patients completed the study, 19 in each group', 'Forty-four patients with a single-rooted tooth to be extracted and replaced by a dental implant were recruited for this study']",['mineralized and demineralized freeze-dried bone allograft'],"['percentage of residual graft', 'morphological changes', 'wound healing', 'morphological ridge dimensions', 'mean percent vital bone formation']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1299987', 'cui_str': 'REPLACED BY (attribute)'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}]","[{'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",44.0,0.103988,"There was a significant difference between the two groups for mean percent vital bone formation (short-term = 18.17%, long-term = 40.32%, p = <.0001) and percentage of residual graft (short-term = 41.54%, long-term = 23.59%, p = <.0001).","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Nelson', 'Affiliation': 'Department of Periodontics, UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Mealey', 'Affiliation': 'Department of Periodontics, UT Health San Antonio, San Antonio, TX.'}]",Journal of periodontology,['10.1002/JPER.19-0610']
3572,31876036,Does a regular nurse-led distress screening and discussion improve quality of life of breast cancer patients treated with curative intent? A randomized controlled trial.,"OBJECTIVE


We performed a randomized controlled trial (RCT) to investigate whether regular screening with the distress thermometer (DT) by a nurse improved global quality of life (QOL) of patients with breast cancer (BC) treated with curative intent.
METHODS


BC patients were randomized between regular screening for distress with a nurse-led DT intervention (NDTI) and usual care (UC). Both groups filled out questionnaires at baseline, after each received treatment modality and at follow-up visits up to 2 years. At these points, the intervention group received also the NDTI. The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after the end of treatment. Analyses were done on an intention-to-treat basis, using analysis of covariance (ANCOVA), generalized least squares, and interaction analyses.
RESULTS


Of 194 randomized patients, 153 filled out the questionnaires up to 2 years after treatment. There was no significant difference between NDTI and UC in global QOL 2 years after the end of treatment (mean diff. = -1∙273, P = .610; 95% CI [-6.195; 3.649]). Subgroup analysis of patients who received multimodality treatment (surgery, radiotherapy, and chemotherapy, n = 66) showed a significant between-group difference in global QOL over time (mean diff. = -10, P < .001; 95% CI [-14.835; -5.167]) together with other secondary outcome measures in favor of the NDTI.
CONCLUSION


NDTI did not lead to a significant improvement in global QOL 2 years after the end of treatment for patients with BC. However, the findings indicate that BC patients who received multimodality treatment may benefit from NDTI.",2020,The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after end of treatment.,"['breast cancer patients treated with curative intent', '194 randomized patients', 'patients with breast cancer (BC) treated with curative intent', 'BC patients']","['regular screening for distress with a nurse-led DT intervention (NDTI) and usual care (UC', 'regular nurse-led distress screening and discussion', 'multimodality treatment (surgery, radiotherapy, and chemotherapy', 'regular screening with the DT']","['global QOL of the EORTC QLQ C30', 'quality of life', 'NDTI and UC in global QOL', 'global QOL']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}]",194.0,0.100054,The primary outcome was the global QOL of the EORTC QLQ C30 at 2 years after end of treatment.,"[{'ForeName': 'Floortje K', 'Initials': 'FK', 'LastName': 'Ploos van Amstel', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Marlies E W J', 'Initials': 'MEWJ', 'LastName': 'Peters', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Donders', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Margrethe S', 'Initials': 'MS', 'LastName': 'Schlooz-Vries', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lenny J M', 'Initials': 'LJM', 'LastName': 'Polman', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T A', 'Initials': 'WTA', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Judith B', 'Initials': 'JB', 'LastName': 'Prins', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5324']
3573,32036576,"Ketogenic diets as an adjuvant therapy for glioblastoma (KEATING): a randomized, mixed methods, feasibility study.","PURPOSE


We conducted a feasibility study to investigate the use of ketogenic diets (KDs) as an adjuvant therapy for patients with glioblastoma (GBM), investigating (i) trial feasibility; (ii) potential impacts of the trial on patients' quality of life and health; (iii) patients' perspectives of their decision-making when invited to participate in the trial and (iv) recommending improvements to optimize future phase III trials.
METHODS


A single-center, prospective, randomized, pilot study (KEATING), with an embedded qualitative design. Twelve newly diagnosed patients with GBM were randomized 1:1 to modified ketogenic diet (MKD) or medium chain triglyceride ketogenic diet (MCTKD). Primary outcome was retention at three months. Semi-structured interviews were conducted with a purposive sample of patients and caregivers (n = 15). Descriptive statistics were used for quantitative outcomes and qualitative data were analyzed thematically aided by NVivo.
RESULTS


KEATING achieved recruitment targets, but the recruitment rate was low (28.6%). Retention was poor; only four of 12 patients completed the three-month diet (MCTKD n = 3; MKD n = 1). Participants' decisions were intuitive and emotional; caregivers supported diet implementation and influenced the patients' decision to participate. Those who declined made a deliberative and considered decision factoring diet burden and quality of life. A three-month diet was undesirable to patients who declined and withdrew.
CONCLUSION


Recruitment to a KD trial for patients with GBM is possible. A six-week intervention period is proposed for a phase III trial. The role of caregivers should not be underestimated. Future trials should optimize and adequately support the decision-making of patients.",2020,Retention was poor; only four of 12 patients completed the three-month diet (MCTKD n = 3; MKD n = 1).,"['Twelve newly diagnosed patients with GBM', 'patients with GBM', 'patients with glioblastoma (GBM']","['Ketogenic diets', 'ketogenic diets (KDs', 'modified ketogenic diet (MKD) or medium chain triglyceride ketogenic diet (MCTKD']",['recruitment rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",12.0,0.0611735,Retention was poor; only four of 12 patients completed the three-month diet (MCTKD n = 3; MKD n = 1).,"[{'ForeName': 'Kirsty J', 'Initials': 'KJ', 'LastName': 'Martin-McGill', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK. Kirsty.martin@liverpool.ac.uk.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Marson', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Tudur Smith', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Mills', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Lower Lane, Liverpool, L9 7LJ, UK.'}, {'ForeName': 'M Gemma', 'Initials': 'MG', 'LastName': 'Cherry', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Jenkinson', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Brownlow Hill, Liverpool, L69 3BX, UK.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03417-8']
3574,32007099,Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial.,"BACKGROUND


Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The Clinical utilisation of respiratory elastance (CURE) trial is a two-arm, randomised controlled trial (RCT) investigating the performance of PEEP selected at an objective, model-based minimal respiratory system elastance in patients with ARDS.
METHODS AND DESIGN


The CURE RCT compares two groups of patients requiring invasive MV with a partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio ≤ 200; one criterion of the Berlin consensus definition of moderate (≤ 200) or severe (≤ 100) ARDS. All patients are ventilated using pressure controlled (bi-level) ventilation with tidal volume = 6-8 ml/kg. Patients randomised to the control group will have PEEP selected per standard practice (SPV). Patients randomised to the intervention will have PEEP selected based on a minimal elastance using a model-based computerised method. The CURE RCT is a single-centre trial in the intensive care unit (ICU) of Christchurch hospital, New Zealand, with a target sample size of 320 patients over a maximum of 3 years. The primary outcome is the area under the curve (AUC) ratio of arterial blood oxygenation to the fraction of inspired oxygen over time. Secondary outcomes include length of time of MV, ventilator-free days (VFD) up to 28 days, ICU and hospital length of stay, AUC of oxygen saturation (SpO 2 )/FiO 2  during MV, number of desaturation events (SpO 2  < 88%), changes in respiratory mechanics and chest x-ray index scores, rescue therapies (prone positioning, nitric oxide use, extracorporeal membrane oxygenation) and hospital and 90-day mortality.
DISCUSSION


The CURE RCT is the first trial comparing significant clinical outcomes in patients with ARDS in whom PEEP is selected at minimum elastance using an objective model-based method able to quantify and consider both inter-patient and intra-patient variability. CURE aims to demonstrate the hypothesized benefit of patient-specific PEEP and attest to the significance of real-time monitoring and decision-support for MV in the critical care environment.
TRIAL REGISTRATION


Australian New Zealand Clinical Trial Registry, ACTRN12614001069640. Registered on 22 September 2014. (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366838&isReview=true) The CURE RCT clinical protocol and data usage has been granted by the New Zealand South Regional Ethics Committee (Reference number: 14/STH/132).",2020,"The Clinical utilisation of respiratory elastance (CURE) trial is a two-arm, randomised controlled trial (RCT) investigating the performance of PEEP selected at an objective, model-based minimal respiratory system elastance in patients with ARDS.
","['320 patients over a maximum of 3\u2009years', 'patients with acute respiratory distress syndrome (ARDS', 'All patients are ventilated using pressure controlled (bi-level) ventilation with tidal volume\u2009=\u20096-8\u2009ml/kg', 'patients with ARDS', 'mechanical ventilation']","['Model-based PEEP titration', 'https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366838&isReview=true', 'control group will have PEEP selected per standard practice (SPV', 'Positive end-expiratory pressure (PEEP', 'mechanical ventilation (MV']","['length of time of MV, ventilator-free days (VFD) up to 28\u2009days, ICU and hospital length of stay, AUC of oxygen saturation (SpO 2 )/FiO', 'area under the curve (AUC) ratio of arterial blood oxygenation to the fraction of inspired oxygen over time', '2  during MV, number of desaturation events', 'changes in respiratory mechanics and chest x-ray index scores, rescue therapies (prone positioning, nitric oxide use, extracorporeal membrane oxygenation) and hospital and 90-day mortality']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood (substance)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.309239,"The Clinical utilisation of respiratory elastance (CURE) trial is a two-arm, randomised controlled trial (RCT) investigating the performance of PEEP selected at an objective, model-based minimal respiratory system elastance in patients with ARDS.
","[{'ForeName': 'Kyeong Tae', 'Initials': 'KT', 'LastName': 'Kim', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand. kyeong.kim@canterbury.ac.nz.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Morton', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Howe', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Yeong Shiong', 'Initials': 'YS', 'LastName': 'Chiew', 'Affiliation': 'School of Engineering, Monash University, Bandar Sunway, Malaysia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Knopp', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Docherty', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pretty', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Desaive', 'Affiliation': 'GIGA Cardiovascular Science, University of Liege, Liege, Belgium.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Benyo', 'Affiliation': 'Department of Control Engineering and Information, Budapest University of Technology and Economics, Budapest, Hungary.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Szlavecz', 'Affiliation': 'Department of Control Engineering and Information, Budapest University of Technology and Economics, Budapest, Hungary.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Moeller', 'Affiliation': 'Institute of Technical Medicine (ITeM), HFU Furtwangen University, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Shaw', 'Affiliation': 'Department of Intensive Care, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'J Geoffrey', 'Initials': 'JG', 'LastName': 'Chase', 'Affiliation': 'Centre for Bioengineering, University of Canterbury, Christchurch, New Zealand.'}]",Trials,['10.1186/s13063-019-4035-7']
3575,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3576,32029304,"Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study.","BACKGROUND


Previous studies showed the potential effectiveness of delgocitinib ointment, a novel topical Janus kinase inhibitor, in atopic dermatitis (AD).
OBJECTIVE


This study aimed to evaluate the efficacy and safety of delgocitinib 0.5% ointment.
METHODS


In part 1, a 4-week double-blind period, Japanese patients aged 16 years or older with moderate or severe AD were randomly assigned in a 2:1 ratio to delgocitinib 0.5% ointment or vehicle ointment. Eligible patients entered part 2, a 24-week extension period, to receive delgocitinib 0.5% ointment.
RESULTS


At the end of treatment in part 1, the least-squares mean percent changes from baseline in the modified Eczema Area and Severity Index score, the primary efficacy endpoint, were significantly greater in the delgocitinib group than in the vehicle group (-44.3% vs 1.7%, P < .001). The improvement in modified Eczema Area and Severity Index score was maintained in part 2. Most adverse events were mild and unrelated to delgocitinib across the study periods.
LIMITATIONS


Only Japanese patients were included. The vehicle-controlled period lasted only 4 weeks. In part 2, topical corticosteroids were allowed for the treatment of worsening of AD.
CONCLUSION


Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.",2020,Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.,"['Only Japanese patients', 'Japanese adult patients with moderate to severe AD for up to 28\xa0weeks', 'adult patients with moderate to severe atopic dermatitis', 'Japanese patients aged 16\xa0years or older with moderate or severe AD', 'atopic dermatitis (AD']","['topical Janus kinase inhibitor', 'topical corticosteroids', 'delgocitinib 0.5% ointment', 'delgocitinib ointment', 'delgocitinib 0.5% ointment or vehicle ointment', 'Delgocitinib ointment']","['modified Eczema Area and Severity Index score', 'effective and well tolerated', 'efficacy and safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4521962', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.155106,Delgocitinib ointment was effective and well tolerated in Japanese adult patients with moderate to severe AD for up to 28 weeks.,"[{'ForeName': 'Hidemi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Kaino', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan. Electronic address: takeshi.nagata@jt.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.12.015']
3577,31876012,Long-term efficacy of meaning-centered group psychotherapy for cancer survivors: 2-Year follow-up results of a randomized controlled trial.,"OBJECTIVE


Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) is an effective intervention to improve personal meaning, psychological well-being, and depressive symptoms until 6 months after the intervention. In this study, the long-term effects of MCGP-CS (i.e., at 1- and 2-year follow-up) on meaning, psychological well-being and posttraumatic growth were assessed, in comparison to supportive group psychotherapy (SGP) and care as usual (CAU).
METHODS


Cancer survivors (n = 170) were randomized into MCGP-CS, SGP, or CAU. Assessments were scheduled at baseline, 1 week, 3 months, 6 months, 1 year, and 2 years postintervention. Outcome measures were the Personal Meaning Profile, Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory, and their subscales. Linear mixed models (LMM) were used and results were both reported on an intention-to-treat (ITT) basis, as well as for intervention completers only.
RESULTS


LMM and post hoc analyses with Bonferroni correction revealed that MCGP-CS participants reported more improvement on positive relations (subscale of SPWB) than CAU participants of 2-year postintervention (ITT analysis, Cohen's d = .82). Completers also reported more personal growth (subscale of SPWB) after MCGP-CS than after SGP 1-year postintervention (Cohen's d = .94). No long-term effects were found on the other outcome measures.
CONCLUSIONS


In the 2 years after MCGP-CS, the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded. However, MCGP-CS had a long-term positive effect on positive relations with others and on survivors' sense of personal growth.
TRIAL REGISTRATION


Netherlands Trial Register: NTR3571.",2020,In the two years after MCGP-CS the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded.,"['cancer survivors (MCGP-CS', 'cancer survivors', 'Cancer survivors (n=170']","['meaning-centered group psychotherapy', 'MCGP-CS', 'Meaning-centered group psychotherapy', 'MCGP-CS, SGP or CAU', 'supportive group psychotherapy (SGP) and care as usual (CAU']","['positive relations (subscale of SPWB', ""Personal Meaning Profile (PMP), Ryff's Scales of Psychological Well-Being (SPWB), the Posttraumatic Growth Inventory (PTGI), and their subscales"", 'personal meaning', 'personal growth (subscale of SPWB']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.154505,In the two years after MCGP-CS the short-term significant effects on personal meaning and most positive effects related to psychological well-being faded.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'van der Spek', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute (APH), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Psycho-oncology,['10.1002/pon.5323']
3578,31704108,Awareness of and Receptivity to the Fresh Empire Tobacco Public Education Campaign Among Hip Hop Youth.,"PURPOSE


The aim of the study was to assess awareness of and receptivity to the U.S. Food and Drug Administration's Fresh Empire tobacco public education campaign designed to reach Hip Hop-identified youth, who are at higher smoking risk.
METHODS


The evaluation uses a randomized treatment-control design with 15 campaign-targeted treatment and 15 control markets. We conducted surveys among 12- to 17-year-olds before campaign launch and at approximately 6-month intervals. Analyses explore treatment-control differences in Fresh Empire brand and video advertisement awareness at individual survey rounds and over time and perceived effectiveness of advertisements.
RESULTS


Awareness of the Fresh Empire brand was higher among youth in treatment than control markets following campaign launch (ps < .01). Awareness of the Fresh Empire brand increased more in treatment than control over time (adjusted odds ratio = 3.26, 95% confidence interval = 1.90-5.58). At follow-ups 1 and 3, youth in treatment (vs. control) were more likely to report high and less likely to report low awareness of video advertisements (ps < .05). There were no treatment-control differences in video awareness at follow-up 2 (not significant). Fresh Empire video advertisements had perceived effectiveness scores ranging from 3.66 to 4.11 (1-5 scale) across three survey rounds.
CONCLUSIONS


Among the campaign audience of Hip Hop-identified youth, awareness of the Fresh Empire campaign was higher in treatment than control markets at individual survey rounds, and increases in campaign awareness were greater in treatment than control markets over time. Campaign advertisements also elicited positive audience reactions. Findings suggest that heavily digital campaigns may take longer to achieve Centers for Disease Control and Prevention-recommended 75% quarterly awareness.",2020,"Awareness of the Fresh Empire brand increased more in treatment than control over time (adjusted odds ratio = 3.26, 95% confidence interval = 1.90-5.58).","['12- to 17-year-olds before campaign launch and at approximately 6-month intervals', 'Hip Hop Youth']",[],"['campaign awareness', 'video awareness', 'effectiveness scores']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.017081,"Awareness of the Fresh Empire brand increased more in treatment than control over time (adjusted odds ratio = 3.26, 95% confidence interval = 1.90-5.58).","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Guillory', 'Affiliation': 'Prime Affect Research, Dublin, Leinster, Ireland. Electronic address: jamieguillory.contractor@rti.org.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Henes', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Farrelly', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Fiacco', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Ishrat', 'Initials': 'I', 'LastName': 'Alam', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Curry', 'Affiliation': 'Center for Health Policy Science and Tobacco Research, RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Ganz', 'Affiliation': 'Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Hoffman', 'Affiliation': 'Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Delahanty', 'Affiliation': 'Center for Tobacco Products, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.09.005']
3579,32015461,"Double blind, two dose, randomized, placebo-controlled, cross-over clinical trial of the positive allosteric modulator at the alpha7 nicotinic cholinergic receptor AVL-3288 in schizophrenia patients.","Despite their theoretical rationale, nicotinic alpha-7 acetylcholine (nα 7 ) receptor agonists, have largely failed to demonstrate efficacy in placebo-controlled trials in schizophrenia. AVL-3288 is a nα 7  positive allosteric modulator (PAM), which is only active in the presence of the endogenous ligand (acetylcholine), and thus theoretically less likely to cause receptor desensitization. We evaluated the efficacy of AVL-3288 in a Phase 1b, randomized, double-blind, placebo-controlled, triple cross-over study. Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) ≥62 were randomized. Each subject received 5 days of AVL-3288 (10, 30 mg) and placebo across three separate treatment weeks. The primary outcome measure was the RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker. Secondary outcome measures include task-based fMRI (RISE task), mismatch negativity, the Scale for the Assessment of Negative Symptoms of Schizophrenia (SANS) and the Brief Psychiatric Rating Scale (BPRS). Twenty-four subjects were randomized and treated without any clinically significant treatment emergent adverse effects. Baseline RBANS (82 ± 17) and BPRS (41 ± 13) scores were consistent with moderate impairment. Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS. In conclusion, the results did not indicate efficacy of the compound, consistent with most prior results for the nα 7  target.",2020,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","['schizophrenia patients', 'Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a repeatable battery for the assessment of neuropsychological status (RBANS) ≥62 were randomized']","['placebo', 'AVL-3288']","['task-based fMRI (RISE task), mismatch negativity, the scale for the assessment of negative symptoms of schizophrenia (SANS) and the brief psychiatric rating scale (BPRS', 'RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3850132', 'cui_str': 'P50 Wave'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",24.0,0.429793,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, USA. jk3380@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'U Colorado, Denver, CO, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Vail', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0628-9']
3580,32001805,Association of the genetic ancestry with resistant hypertension in the ReHOT (Resistant Hypertension Optimal Treatment) randomized study.,"Resistant hypertension (RH) is defined as uncontrolled blood pressure despite treatment with three or more antihypertensive medications, including, if tolerated, a diuretic in adequate doses. It has been widely known that race is associated with blood pressure control. However, intense debate persists as to whether this is solely explained by unadjusted socioeconomical variables or genetic variation. In this scenario, the main aim was to evaluate the association between genetic ancestry and resistant hypertension in a large sample from a multicenter trial of stage II hypertension, the ReHOT study. Samples from 1,358 patients were analyzed, of which 167 were defined as resistant hypertensive. Genetic ancestry was defined using a panel of 192 polymorphic markers. The genetic ancestry was similar in resistant (52.0% European, 36.7% African and 11.3% Amerindian) and nonresistant hypertensive patients (54.0% European, 34.4% African and 11.6% Amerindian) (p > 0.05). However, we observed a statistically suggestive association of African ancestry with resistant hypertension in brown patient group. In conclusion, increased African genetic ancestry was not associated with RH in Brazilian patients from a prospective randomized hypertension clinical trial.",2020,"The genetic ancestry was similar in resistant (52.0% European, 36.7% African and 11.3% Amerindian) and nonresistant hypertensive patients (54.0% European, 34.4% African and 11.6% Amerindian) (p > 0.05).","['1,358 patients were analyzed, of which 167 were defined as resistant hypertensive']",[],['African genetic ancestry'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]",[],"[{'cui': 'C0017399', 'cui_str': 'genetics'}]",1358.0,0.0387439,"The genetic ancestry was similar in resistant (52.0% European, 36.7% African and 11.3% Amerindian) and nonresistant hypertensive patients (54.0% European, 34.4% African and 11.6% Amerindian) (p > 0.05).","[{'ForeName': 'Carolina Tosin', 'Initials': 'CT', 'LastName': 'Bueno', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Alexandre Costa', 'Initials': 'AC', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Hadassa Campos', 'Initials': 'HC', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Luz Marina Gómez', 'Initials': 'LMG', 'LastName': 'Gómez', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Andrea Roseli Vançan Russo', 'Initials': 'ARVR', 'LastName': 'Horimoto', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Eduardo Moacyr', 'Initials': 'EM', 'LastName': 'Krieger', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Jose Eduardo', 'Initials': 'JE', 'LastName': 'Krieger', 'Affiliation': 'Laboratory of Genetics and Molecular Cardiology, Heart Institute, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Paulo Caleb Junior Lima', 'Initials': 'PCJL', 'LastName': 'Santos', 'Affiliation': 'Department of Pharmacology - Escola Paulista de Medicina, Universidade Federal de Sao Paulo EPM-Unifesp, São Paulo, Brazil. paulo.caleb@unifesp.br.'}]",Scientific reports,['10.1038/s41598-020-58540-3']
3581,31930369,Extended Follow-up From a Randomized Clinical Trial of Routine Amoxicillin in the Treatment of Uncomplicated Severe Acute Malnutrition in Niger.,,2020,,['Uncomplicated Severe Acute Malnutrition in Niger'],['Routine Amoxicillin'],[],"[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]",[],,0.0562534,,"[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Kyra H', 'Initials': 'KH', 'LastName': 'Grantz', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Berthé', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Médecins Sans Frontières Operational Center Paris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Adehossi', 'Affiliation': 'National Hospital, Niamey, Niger.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5189']
3582,32036192,Perinatal contraceptive counselling: Effectiveness of a reinforcement intervention on top of standard clinical practice.,"OBJECTIVE


To assess the effectiveness of supplemental perinatal contraceptive counselling in addition to standard Spanish postpartum contraceptive counselling with regard to contraceptive use and use of effective contraception up to 1 year postpartum. Women's satisfaction with counselling and the method chosen was also assessed.
DESIGN


Community-randomized trial.
SETTING


""Reproductive and Sexual Health Care"" units of the National Health Care System at twenty public Primary Care facilities in Catalonia (Spain).
PARTICIPANTS


1,004 consecutive pregnant women (~week 30) receiving prenatal care between 1st October 2015 and 31st March 2016. Women were considered eligible for analysis if appropriate information was available.
INTERVENTIONS


At half of the centres, midwives provided the standard Spanish postpartum contraceptive counselling (control group, CG). At the other half, supplemental perinatal contraceptive counselling was provided in addition to standard counselling (intervention group, IG) at different time points during pregnancy and postpartum. This consisted of a leaflet and a blog with practical information about all contraceptive options plus a short reminder message in the mobile phone during the third quarter of pregnancy and a face-to-face or a virtual meeting lasting 20 min in the first 15 days postpartum. Midwives used ad hoc questionnaires to collect information at week 30 of pregnancy (recruitment), and week 6, month 6 and month 12 postpartum.
MEASUREMENTS AND FINDINGS


975 women were eligible for analysis (482 in the CG and 493 in the IG). ~33% women had resumed sexual intercourse by week 6, and nearly all by months 6 and 12. Use and effectiveness of contraceptives was similar in both groups at week 6 and month 6. At month 12, more women in the IG used more effective contraception and less women used contraceptives considered somewhat effective vs. those of the CG (P = 0.006). When considering the place of origin, this was only true for Spanish women. Women of other origins had a much higher use of very effective contraceptives at month 12 also in the CG, with contraceptive counselling having scarce effect. On multivariate analysis, conducted only in Spanish women, the additional counselling resulted in a higher use of highly effective methods while having a university degree increased 3.6 times the OR for this behaviour. A bias towards fostering use of very effective contraceptives among women with low education was seen in standard clinical practice. Satisfaction with counselling and the type of contraception chosen was higher in the IG.
KEY CONCLUSIONS


Our study has shown that the supplemental counselling tested has a moderate impact on contraceptive use and use of effective contraception in postpartum women. Results of this effort were seen after 6 months postpartum. A possible bias towards women who were more socially vulnerable was found in standard clinical practice, which reduced the effectiveness of the intervention in women who were otherwise the most needy.
IMPLICATIONS FOR PRACTICE


Despite the benefits provided by supplemental support in perinatal contraceptive counselling, the existence of a possible bias affecting the effectiveness of these interventions should be investigated and addressed.",2020,"Women of other origins had a much higher use of very effective contraceptives at month 12 also in the CG, with contraceptive counselling having scarce effect.","['1,004 consecutive pregnant women (~week 30) receiving prenatal care between 1st October 2015 and 31st March 2016', '975 women were eligible for analysis (482 in the CG and 493 in the IG', 'Reproductive and Sexual Health Care"" units of the National Health Care System at twenty public Primary Care facilities in Catalonia (Spain', 'postpartum women', '33']","['supplemental perinatal contraceptive counselling', 'reinforcement intervention', 'Perinatal contraceptive counselling']","['effective contraception', 'sexual intercourse']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C4517911', 'cui_str': '975 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}]",975.0,0.0987239,"Women of other origins had a much higher use of very effective contraceptives at month 12 also in the CG, with contraceptive counselling having scarce effect.","[{'ForeName': 'Azahara', 'Initials': 'A', 'LastName': 'Reyes-Lacalle', 'Affiliation': 'Grup Emergent Consolidat en Atenció a la Salut sexual i Reproductiva (GRASSIR), Institut Catala de la Salut (ICS), Sabadell, Barcelona, Spain. Electronic address: areyesl.ics@gencat.cat.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Montero-Pons', 'Affiliation': 'Grup Emergent Consolidat en Atenció a la Salut sexual i Reproductiva (GRASSIR), Institut Catala de la Salut (ICS), Santa Coloma de Gramanet, Barcelona, Spain.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Manresa-Domínguez', 'Affiliation': ""Unitat de Suport a la Recerca Metropolitana Nord del IDIAP Jordi Gol, Cerdanyola del Valles, Barcelona, Spain; Departament d'Infermeria, Universitat Autonoma de Barcelona, Cerdanyola del Valles, Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Cabedo-Ferreiro', 'Affiliation': 'Grup Emergent Consolidat en Atenció a la Salut sexual i Reproductiva (GRASSIR), Institut Catala de la Salut (ICS), Granollers, Barcelona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Seguranyes', 'Affiliation': 'Nursing School, Universitat de Barcelona, Grup Emergent Consolidat en Atenció a la Salut sexual i Reproductiva (GRASSIR), Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Falguera-Puig', 'Affiliation': ""Coordinadora Grup Emergent Consolidat en Atenció a la Salut Sexual i Reproductiva (GRASSIR), Direccio d'Atenció Primaria Metropolitana Nord, Institut Catala de la Salut (ICS), Barcelona, Spain.""}]",Midwifery,['10.1016/j.midw.2020.102631']
3583,31348053,Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial.,"BACKGROUND


Patients with lung cancer often experience reduced functional capacity and quality of life after surgery. The current study investigated the impact of a short-term, home-based, multimodal prehabilitation program on perioperative functional capacity in patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy for nonsmall cell lung cancer (NSCLC).
METHODS


A randomized controlled trial was conducted with 73 patients. Patients in the prehabilitation group (n = 37) received a 2-week multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance. Patients in the control group (n = 36) received the usual clinical care. The assessors were blinded to the patient allocation. The primary outcome was perioperative functional capacity measured as the 6-minute walk distance (6MWD), which was assessed at 1 day before and 30 days after surgery. A linear mixed-effects model was built to analyze the perioperative 6MWD. Other outcomes included lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality.
RESULTS


The median duration of prehabilitation was 15 days. The average 6MWD was 60.9 m higher perioperatively in the prehabilitation group compared to the control group (95% confidence interval [CI], 32.4-89.5; P < .001). There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
CONCLUSIONS


A 2-week, home-based, multimodal prehabilitation program could produce clinically relevant improvements in perioperative functional capacity in patients undergoing VATS lobectomy for lung cancer.",2020,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","['Patients in the prehabilitation group (n = 37', 'patients undergoing', '73 patients', 'Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer', 'patients undergoing VATS lobectomy for lung cancer', 'nonsmall cell lung cancer (NSCLC', 'Patients with lung cancer']","['short-term, home-based, multimodal prehabilitation program', 'usual clinical care', 'multimodal intervention program before surgery, including aerobic and resistance exercises, respiratory training, nutrition counseling with whey protein supplementation, and psychological guidance', 'video-assisted thoracoscopic surgery (VATS) lobectomy']","['median duration of prehabilitation', 'Perioperative Functional Capability', 'lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity', 'perioperative functional capacity measured as the 6-minute walk distance (6MWD', 'functional capacity and quality of life', 'perioperative functional capacity', 'lung function, disability and psychometric evaluations, length of stay (LOS), short-term recovery quality, postoperative complications, and mortality', 'average 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4520228', 'cui_str': 'VATS (video-assisted thoracoscopic surgery) lobectomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.141417,"There were no differences in lung function, disability and psychological assessment, LOS, short-term recovery quality, postoperative complications, and mortality, except for forced vital capacity (FVC; 0.35 L higher in the prehabilitation group, 95% CI, 0.05-0.66; P = .021).
","[{'ForeName': 'Zijia', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the *Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China †Central Research Laboratory, Peking Union Medical College Hospital, Beijing, China Departments of ‡Thoracic Surgery §Enteral and Parenteral Nutrition, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Lijian', 'Initials': 'L', 'LastName': 'Pei', 'Affiliation': ''}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yushang', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': ''}, {'ForeName': 'Naixin', 'Initials': 'N', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Shanqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004342']
3584,31995688,Family History of Gastric Cancer and  Helicobacter pylori  Treatment.,"BACKGROUND


Helicobacter pylori  infection and a family history of gastric cancer are the main risk factors for gastric cancer. Whether treatment to eradicate  H. pylori  can reduce the risk of gastric cancer in persons with a family history of gastric cancer in first-degree relatives is unknown.
METHODS


In this single-center, double-blind, placebo-controlled trial, we screened 3100 first-degree relatives of patients with gastric cancer. We randomly assigned 1838 participants with  H. pylori  infection to receive either eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin [500 mg], each taken twice daily for 7 days) or placebo. The primary outcome was development of gastric cancer. A prespecified secondary outcome was development of gastric cancer according to  H. pylori  eradication status, assessed during the follow-up period.
RESULTS


A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group). During a median follow-up of 9.2 years, gastric cancer developed in 10 participants (1.2%) in the treatment group and in 23 (2.7%) in the placebo group (hazard ratio, 0.45; 95% confidence interval [CI], 0.21 to 0.94; P = 0.03 by log-rank test). Among the 10 participants in the treatment group in whom gastric cancer developed, 5 (50.0%) had persistent  H. pylori  infection. Gastric cancer developed in 0.8% of participants (5 of 608) in whom  H. pylori  infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70). Adverse events were mild and were more common in the treatment group than in the placebo group (53.0% vs. 19.1%; P<0.001).
CONCLUSIONS


Among persons with  H. pylori  infection who had a family history of gastric cancer in first-degree relatives,  H. pylori  eradication treatment reduced the risk of gastric cancer. (Funded by the National Cancer Center, South Korea; ClinicalTrials.gov number, NCT01678027.).",2020,"Gastric cancer developed in 0.8% of participants (5 of 608) in whom  H. pylori  infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70).","['1838 participants with  H. pylori  infection to receive either', 'persons with  H. pylori  infection who had a family history of gastric cancer in first-degree relatives', 'A total of 1676 participants were included in the modified intention-to-treat population for the analysis of the primary outcome (832 in the treatment group and 844 in the placebo group', 'patients with gastric cancer', 'Family History of Gastric Cancer and  Helicobacter pylori  Treatment']","['placebo', 'eradication therapy (lansoprazole [30 mg], amoxicillin [1000 mg], and clarithromycin']","['risk of gastric cancer', 'persistent  H. pylori  infection', 'Adverse events', 'development of gastric cancer', 'persistent infection', 'Gastric cancer', 'gastric cancer', 'development of gastric cancer according to  H. pylori  eradication status, assessed during the follow-up period']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",1838.0,0.379924,"Gastric cancer developed in 0.8% of participants (5 of 608) in whom  H. pylori  infection was eradicated and in 2.9% of participants (28 of 979) who had persistent infection (hazard ratio, 0.27; 95% CI, 0.10 to 0.70).","[{'ForeName': 'Il Ju', 'Initials': 'IJ', 'LastName': 'Choi', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Chan Gyoo', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jong Yeul', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Myeong-Cherl', 'Initials': 'MC', 'LastName': 'Kook', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Boram', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jungnam', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'From the Center for Gastric Cancer (I.J.C., C.G.K., J.Y.L., Y.-I.K., M.-C.K.), the Division of Cancer Epidemiology and Management, Research Institute (I.J.C., Y.-I.K., B.P., J.J.), and the Biostatistics Collaboration Team, Research Core Center, Research Institute (B.P.) - all at the National Cancer Center, Goyang, South Korea.'}]",The New England journal of medicine,['10.1056/NEJMoa1909666']
3585,32019699,Beyond Performance Metrics: Automatic Deep Learning Retinal OCT Analysis Reproduces Clinical Trial Outcome.,"PURPOSE


To validate the efficacy of a fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics by measuring the primary outcome of a clinical trial for macular telangiectasia type 2 (MacTel2).
DESIGN


Evaluation of diagnostic test or technology.
PARTICIPANTS


A total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324) randomized to 1 of 2 treatment groups METHODS: The ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm. The change in EZ defect area from baseline to month 24 was calculated and analyzed according to the clinical trial protocol.
MAIN OUTCOME MEASURE


Difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups.
RESULTS


The difference in the change in EZ defect area from baseline to month 24 between the 2 treatment groups measured by the fully automatic segmentation algorithm was 0.072±0.035 mm 2  (P = 0.021). This was comparable to the outcome of the clinical trial using semiautomatic measurements by expert readers, 0.065±0.033 mm 2  (P = 0.025).
CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial. This approach, to validate the performance of an automatic segmentation algorithm on the primary clinical trial end point, provides a robust gauge of its clinical applicability.",2020,"CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial.","['A total of 92 eyes from 62 participants with MacTel2 from a phase 2 clinical trial (NCT01949324', 'macular telangiectasia type 2 (MacTel2']","['ellipsoid zone (EZ) defect areas were measured on spectral domain OCT images of each eye at 2 time points (baseline and month 24) by a fully automatic, deep learning-based segmentation algorithm', 'fully automatic, deep learning-based segmentation algorithm beyond conventional performance metrics']",['change in EZ defect area'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1096779', 'cui_str': 'Clinical Trial, Phase 2'}, {'cui': 'C4521693', 'cui_str': 'Telangiectasia of macula lutea'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",92.0,0.117519,"CONCLUSIONS


The fully automatic segmentation algorithm was as accurate as semiautomatic expert segmentation to assess EZ defect areas and was able to reliably reproduce the statistically significant primary outcome measure of the clinical trial.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Loo', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, North Carolina.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'Ophthalmology, Emmes, Rockville, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Molecular Medicine, The Scripps Research Institute, La Jolla, California; The Lowy Medical Research Institute, La Jolla, California.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Farsiu', 'Affiliation': 'Department of Biomedical Engineering, Duke University, Durham, North Carolina; Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina. Electronic address: sina.farsiu@duke.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.12.015']
3586,32019700,Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report.,"PURPOSE


To evaluate the efficacy and safety of 0.05%, 0.025%, and 0.01% atropine eye drops over 2 years to determine which is the optimal concentration for longer-term myopia control.
DESIGN


Randomized, double-masked trial extended from the Low-Concentration Atropine for Myopia Progression (LAMP) Study.
PARTICIPANTS


Three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least -1.0 diopter (D) originally randomized to receive atropine 0.05%, 0.025%, 0.01%, or placebo once daily in both eyes in the LAMP phase 1 study were continued in this extended trial (phase 2).
METHODS


Children in the placebo group (phase 1) were switched to receive 0.05% atropine from the beginning of the second-year follow-up, whereas those in the 0.05%, 0.025%, and 0.01% atropine groups continued with the same regimen. Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity were measured at 4-month intervals.
MAIN OUTCOME MEASURES


Changes in spherical equivalent (SE) and AL and their differences between groups.
RESULTS


Over the 2-year period, the mean SE progression was 0.55±0.86 D, 0.85±0.73 D, and 1.12±0.85 D in the 0.05%, 0.025%, and 0.01% atropine groups, respectively (P = 0.015, P < 0.001, and P = 0.02, respectively, for pairwise comparisons), with mean AL changes over 2 years of 0.39±0.35 mm, 0.50±0.33 mm, and 0.59±0.38 mm (P = 0.04, P < 0.001, and P = 0.10, respectively). Compared with the first year, the second-year efficacy of 0.05% and 0.025% atropine remained similar (P >0.1), but improved mildly in the 0.01% atropine group (P = 0.04). For the phase 1 placebo group, the myopia progression was reduced significantly after switching to 0.05% atropine (SE change, 0.18 D in second year vs. 0.82 D in first year [P < 0.001]; AL elongated 0.15 mm in second year vs. 0.43 mm in first year [P < 0.001]). Accommodation loss and change in pupil size in all concentrations remained similar to the first-year results and were well tolerated. Visual acuity and vision-related quality of life remained unaffected.
CONCLUSIONS


Over 2 years, the efficacy of 0.05% atropine observed was double that observed with 0.01% atropine, and it remained the optimal concentration among the studied atropine concentrations in slowing myopia progression.",2020,"Visual acuity and vision-related quality of life remained unaffected.
","['Three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least -1.0 diopter (D', 'Myopia\xa0Progression (LAMP', 'Children in the']","['Low-Concentration Atropine', 'placebo', 'atropine']","['Visual acuity and vision-related quality of life', 'efficacy and safety', 'Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity', 'Changes in spherical equivalent (SE) and AL', 'mean SE progression', 'tolerated', 'Myopia Progression (LAMP', 'Accommodation loss and change in pupil size', 'myopia progression']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0855713', 'cui_str': 'Wet refraction'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",438.0,0.526804,"Visual acuity and vision-related quality of life remained unaffected.
","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Yam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China. Electronic address: yamcheuksing@cuhk.edu.hk.'}, {'ForeName': 'Fen Fen', 'Initials': 'FF', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xiujuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Shu Min', 'Initials': 'SM', 'LastName': 'Tang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Benjamin H K', 'Initials': 'BHK', 'LastName': 'Yip', 'Affiliation': 'Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ka Wai', 'Initials': 'KW', 'LastName': 'Kam', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Simon T', 'Initials': 'ST', 'LastName': 'Ko', 'Affiliation': 'Department of Ophthalmology, Tung Wah Eastern Hospital, Hong Kong, China.'}, {'ForeName': 'Alvin L', 'Initials': 'AL', 'LastName': 'Young', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Clement C', 'Initials': 'CC', 'LastName': 'Tham', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Hong Kong Eye Hospital, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Li Jia', 'Initials': 'LJ', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China; Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital, Hong Kong, China.'}, {'ForeName': 'Chi Pui', 'Initials': 'CP', 'LastName': 'Pang', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}]",Ophthalmology,['10.1016/j.ophtha.2019.12.011']
3587,32008063,A theory-based randomized controlled trial in promoting fruit and vegetable intake among schoolchildren: PROFRUVE study.,"PURPOSE


The main objective of the PROFRUVE study was to evaluate the effectiveness of a TPB-based intervention program at increasing fruit and vegetable (FV) consumption in schoolchildren aged 7-10.
METHODS


Eight eligible classrooms were randomly assigned to the intervention (classrooms n = 4; children n = 90) or control group (classrooms n = 4; children n = 95). The intervention group received 14 sessions of 1 h during an academic year (from October to June) but the control group did not. Sessions were based on the Theory of Planned Behavior (TPB) and focused on modifying FV intake. FV consumption was evaluated before, shortly after and 1 year after intervention ended using validated 7-day food records.
RESULTS


FV intake increased significantly in the intervention group (+ 0.45 servings/day; 95% CI 0.17-0.74; p = 0.001) but not in the control group (+ 0.01 servings/day; 95% CI -0.20-0.22; p = 0.409) shortly after the intervention. Long-term measurement showed that 1 year after intervention finished, the intervention group maintained the effect (+ 0.52 servings/day from baseline; 95% CI 0.22-0.78; p = 0.003). Linear mixed model also showed that nested groups by classrooms differ from intervention and control groups regarding FV intake change (p = 0.002). Multiple linear regression showed that receiving the intervention (B = 0.345, p = 0.045) and FV baseline intake (B = - 0.383, p = 0.000) were associated with FV intake change after adjusting the model by age, gender and family social economic status (SES) (R 2  = 0.196).
CONCLUSIONS


The intervention program based on TPB seemed to be moderately effective in increasing FV intake and successful in maintaining the effect of the reached increase. Moreover, baseline FV intake determined the effect size of the intervention.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov. Identifier: NCT03400891. Data registered 17/01/2018.",2020,"RESULTS


FV intake increased significantly in the intervention group (+ 0.45 servings/day; 95% CI 0.17-0.74; p = 0.001) but not in the control group (+ 0.01 servings/day; 95% CI -0.20-0.22; p = 0.409) shortly after the intervention.","['schoolchildren', 'schoolchildren aged 7-10', 'Eight eligible classrooms']","['TPB-based intervention program at increasing fruit and vegetable (FV) consumption', 'intervention (classrooms n\u2009=\u20094; children n\u2009=\u200990) or control group (classrooms n\u2009=\u20094; children n\u2009=\u200995']","['FV intake change', 'FV intake', 'FV baseline intake', 'FV consumption']",[],"[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",8.0,0.0778514,"RESULTS


FV intake increased significantly in the intervention group (+ 0.45 servings/day; 95% CI 0.17-0.74; p = 0.001) but not in the control group (+ 0.01 servings/day; 95% CI -0.20-0.22; p = 0.409) shortly after the intervention.","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Arrizabalaga-López', 'Affiliation': 'Nutrition and Obesity Group, Department of Nutrition and Food Science, Faculty of Pharmacy and Lascaray Research Center, University of the Basque Country UPV/EHU, Paseo de la Universidad 7, 01006, Vitoria-Gasteiz, Spain. maria.arrizabalaga@ehu.eus.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Rada-Fernández de Jáuregui', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'María Del Puy', 'Initials': 'MDP', 'LastName': 'Portillo', 'Affiliation': 'Nutrition and Obesity Group, Department of Nutrition and Food Science, Faculty of Pharmacy and Lascaray Research Center, University of the Basque Country UPV/EHU, Paseo de la Universidad 7, 01006, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jose Ramón', 'Initials': 'JR', 'LastName': 'Mauleón', 'Affiliation': 'Department of Sociology 2, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Olaia', 'Initials': 'O', 'LastName': 'Martínez', 'Affiliation': 'Department of Pharmacy and Food Science, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Iñaki', 'Initials': 'I', 'LastName': 'Etaio', 'Affiliation': 'Department of Pharmacy and Food Science, Faculty of Pharmacy, University of the Basque Country UPV/EHU, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Tormo-Santamaría', 'Affiliation': 'Department of Community Nursing, Preventive Medicine and Public Health and History of Science, University of Alicante, Alicante, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Bernabeu-Maestre', 'Affiliation': 'Department of Community Nursing, Preventive Medicine and Public Health and History of Science, University of Alicante, Alicante, Spain.'}, {'ForeName': 'Víctor Manuel', 'Initials': 'VM', 'LastName': 'Rodríguez', 'Affiliation': 'Nutrition and Obesity Group, Department of Nutrition and Food Science, Faculty of Pharmacy and Lascaray Research Center, University of the Basque Country UPV/EHU, Paseo de la Universidad 7, 01006, Vitoria-Gasteiz, Spain.'}]",European journal of nutrition,['10.1007/s00394-020-02185-5']
3588,32024528,Human arm weight compensation in rehabilitation robotics: efficacy of three distinct methods.,"BACKGROUND


Arm weight compensation with rehabilitation robots for stroke patients has been successfully used to increase the active range of motion and reduce the effects of pathological muscle synergies. However, the differences in structure, performance, and control algorithms among the existing robotic platforms make it hard to effectively assess and compare human arm weight relief. In this paper, we introduce criteria for ideal arm weight compensation, and furthermore, we propose and analyze three distinct arm weight compensation methods (Average, Full, Equilibrium) in the arm rehabilitation exoskeleton 'ARMin'. The effect of the best performing method was validated in chronic stroke subjects to increase the active range of motion in three dimensional space.
METHODS


All three methods are based on arm models that are generalizable for use in different robotic devices and allow individualized adaptation to the subject by model parameters. The first method Average uses anthropometric tables to determine subject-specific parameters. The parameters for the second method Full are estimated based on force sensor data in predefined resting poses. The third method Equilibrium estimates parameters by optimizing an equilibrium of force/torque equations in a predefined resting pose. The parameters for all three methods were first determined and optimized for temporal and spatial estimation sensitivity. Then, the three methods were compared in a randomized single-center study with respect to the remaining electromyography (EMG) activity of 31 healthy participants who performed five arm poses covering the full range of motion with the exoskeleton robot. The best method was chosen for feasibility tests with three stroke patients. In detail, the influence of arm weight compensation on the three dimensional workspace was assessed by measuring of the horizontal workspace at three different height levels in stroke patients.
RESULTS


All three arm weight compensation methods reduced the mean EMG activity of healthy subjects to at least 49% compared with the no compensation reference. The Equilibrium method outperformed the Average and the Full methods with a highly significant reduction in mean EMG activity by 19% and 28% respectively. However, upon direct comparison, each method has its own individual advantages such as in set-up time, cost, or required technology. The horizontal workspace assessment in poststroke patients with the Equilibrium method revealed potential workspace size-dependence of arm height, while weight compensation helped maximize the workspace as much as possible.
CONCLUSION


Different arm weight compensation methods were developed according to initially defined criteria. The methods were then analyzed with respect to their sensitivity and required technology. In general, weight compensation performance improved with the level of technology, but increased cost and calibration efforts. This study reports a systematic way to analyze the efficacy of different weight compensation methods using EMG. Additionally, the feasibility of the best method, Equilibrium, was shown by testing with three stroke patients. In this test, a height dependence of the workspace size also seemed to be present, which further highlights the importance of patient-specific weight compensation, particularly for training at different arm heights.
TRIAL REGISTRATION


ClinicalTrials.gov,NCT02720341. Registered 25 March 2016.",2020,The Equilibrium method outperformed the Average and the Full methods with a highly significant reduction in mean EMG activity by 19% and 28% respectively.,"['chronic stroke subjects', '31 healthy participants who performed five arm poses covering the full range of motion with the exoskeleton robot', 'poststroke patients', 'stroke patients']",[],['mean EMG activity'],"[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",3.0,0.0254357,The Equilibrium method outperformed the Average and the Full methods with a highly significant reduction in mean EMG activity by 19% and 28% respectively.,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Just', 'Affiliation': 'Sensory-Motor Systems (SMS) Lab, Institute of Robotics and Intelligent Systems (IRIS), Department of Health Sciences and Technology (D-HEST), ETH Zurich, Switzerland and Reharobotics Group, Spinal Cord Injury Center, Balgrist University Hospital, Medical Faculty, University of Zurich, Switzerland, Lengghalde 5, Zurich, 8092, Switzerland. fabian.just@hest.ethz.ch.'}, {'ForeName': 'Özhan', 'Initials': 'Ö', 'LastName': 'Özen', 'Affiliation': 'Motor Learning and Neurorehabilitation Laboratory, ARTORG Center for Biomedical Engineering Research, University of Bern, Freiburgstrasse 3, Bern, 3010, Switzerland.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tortora', 'Affiliation': 'IAS-Lab, Department of Information Engineering, University of Padova, via Giovanni Gradenigo 6a, Padova, 35131, Italy.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Klamroth-Marganska', 'Affiliation': 'Institute of Occupational Therapy, School of Health Professions, Zurich University of Applied Sciences, Technikumstrasse 81, Winterthur, 8401, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riener', 'Affiliation': 'Sensory-Motor Systems (SMS) Lab, Institute of Robotics and Intelligent Systems (IRIS), Department of Health Sciences and Technology (D-HEST), ETH Zurich, Switzerland and Reharobotics Group, Spinal Cord Injury Center, Balgrist University Hospital, Medical Faculty, University of Zurich, Switzerland, Lengghalde 5, Zurich, 8092, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rauter', 'Affiliation': 'Sensory-Motor Systems (SMS) Lab, Institute of Robotics and Intelligent Systems (IRIS), Department of Health Sciences and Technology (D-HEST), ETH Zurich, Switzerland and Reharobotics Group, Spinal Cord Injury Center, Balgrist University Hospital, Medical Faculty, University of Zurich, Switzerland, Lengghalde 5, Zurich, 8092, Switzerland.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-0644-3']
3589,32013936,Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study.,"BACKGROUND


Approximately 80% of patients with indwelling ureteral stents experience stent related symptoms (SRS). We believe SRS can be reduced through altering the composition of ureteral stents to a less firm material. Therefore, we aim to compare modern silicone and polyurethane ureteral stents in terms of SRS intensity and safety.
METHODS


From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey 1 h after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.
RESULTS


A total of 50 patients participated in the study, control group A consisted of 20 patients and experimental group B consisted of 30 patients. Participants in group B, silicone ureteral stents, demonstrated significantly lower mean values of VASP 2 weeks prior to stent removal and promptly before stent removal (p = 0.023 and p = 0.014, respectively). No other comparisons between the two groups were statistically significant.
CONCLUSIONS


Compared to polyurethane ureteral stents, silicone ureteral stents are associated with lower body pain intensity assessed by VASP 2 weeks before stent removal and at the time of stent removal.
TRIAL REGISTRATION


Current Controlled Trials NCT04000178. Retrospectively registered on June 26, 2019.",2020,"Participants in group B, silicone ureteral stents, demonstrated significantly lower mean values of VASP 2 weeks prior to stent removal and promptly before stent removal (p = 0.023 and p = 0.014, respectively).","['patients with indwelling ureteral stents experience stent related symptoms (SRS', '50 patients participated in the study', 'From June 2018 to October 2018, patients from two distinct clinical centers']","['silicone ureteral stents', 'silicone stents (Cook Medical', 'polyurethane ureteral stents, silicone ureteral stents', 'polyurethane stents (Rüsch, Teleflex', 'silicone versus polyurethane ureteral stents', 'modern silicone and polyurethane ureteral stents']","['visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool', 'successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates', 'mean values of VASP', 'body pain intensity', 'SRS intensity and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0032616', 'cui_str': 'Ostamer'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.0789475,"Participants in group B, silicone ureteral stents, demonstrated significantly lower mean values of VASP 2 weeks prior to stent removal and promptly before stent removal (p = 0.023 and p = 0.014, respectively).","[{'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Gadzhiev', 'Affiliation': 'Department of Urology, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Gorelov', 'Affiliation': 'Department of Urology, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Vigen', 'Initials': 'V', 'LastName': 'Malkhasyan', 'Affiliation': 'Department of Urology, State University of Medicine and Dentistry, Moscow, Russia.'}, {'ForeName': 'Gagik', 'Initials': 'G', 'LastName': 'Akopyan', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Revaz', 'Initials': 'R', 'LastName': 'Harchelava', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Mazurenko', 'Affiliation': 'Department of Urology, Ilyinskaya Hospital, Moscow, Russia.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kosmala', 'Affiliation': 'Department of Urology, University of California, Irvine, 333 City Boulevard West, Orange, CA, 92868, USA.'}, {'ForeName': 'Zhamshid', 'Initials': 'Z', 'LastName': 'Okhunov', 'Affiliation': 'Department of Urology, University of California, Irvine, 333 City Boulevard West, Orange, CA, 92868, USA.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Petrov', 'Affiliation': 'Department of Urology, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.'}]",BMC urology,['10.1186/s12894-020-0577-y']
3590,32022286,"Effect of Glepaglutide, a Long-Acting Glucagon-Like Peptide-2 Analog, on Gastrointestinal Transit Time and Motility in Patients With Short Bowel Syndrome: Findings From a Randomized Trial.","BACKGROUND


Patients with short bowel syndrome (SBS) and distal-bowel resections lack neuroendocrine feedback regulations, potentially resulting in rapid gastrointestinal (GI) transit. The objective was to assess the efficacy of glepaglutide, a long-acting glucagon-like peptide-2 analog, on GI transit in patients with SBS.
METHODS


In this single-center, double-blind, dose-finding, phase 2 trial, patients with SBS were randomly assigned to 3 treatments (0.1, 1, and 10 mg) in a 2-period crossover design. Each treatment period included 3 weeks of daily, subcutaneous glepaglutide injections separated by a washout period of 4-8 weeks. Endpoints were changes from baseline and included scintigraphy, wireless motility capsule (WMC, SmartPill Given Imaging, Ltd, Yokneam, Israel), and paracetamol absorption test.
RESULTS


A total of 18 patients were randomized. In the 10-mg dose group (n = 9), glepaglutide significantly increased time to 10% gastric emptying (GE) of solids by 27 (4-50) minutes (adjusted mean [95% CI]), time to 50%GE of fluids by 40 (1-80) minutes, and time to 10% small bowel-emptying of solids by 21 (1-41) minutes. The WMC transit did not significantly change in any of the dose groups. The maximum paracetamol concentration significantly increased in the 10-mg dose group; however, the area under the curve remained the same.
CONCLUSION


The prolonged GI transit after glepaglutide treatment, along with demonstrated positive effects on intestinal mucosal growth and potential effects on GI hypersecretions, is believed to contribute to the observed beneficial effects on fecal output (primary endpoint) and associated improvement in intestinal absorption.",2020,The WMC transit did not significantly change in any of the dose groups.,"['patients with SBS.\nMETHODS', '18 patients were randomized', 'Patients With Short Bowel Syndrome', 'patients with SBS', 'Patients with short bowel syndrome (SBS) and distal-bowel resections lack neuroendocrine feedback regulations']","['Glepaglutide, a Long-Acting Glucagon-Like Peptide-2 Analog']","['WMC transit', 'Gastrointestinal Transit Time and Motility', 'time to 50%GE of fluids', 'maximum paracetamol concentration', 'scintigraphy, wireless motility capsule (WMC, SmartPill', 'intestinal absorption', 'prolonged GI transit', 'time to 10% gastric emptying (GE) of solids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0912332', 'cui_str': 'Proglucagon (126-158)'}]","[{'cui': 'C0232484', 'cui_str': 'Gastrointestinal transit time, function (observable entity)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0021826', 'cui_str': 'Intestinal Absorption'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}]",18.0,0.376797,The WMC transit did not significantly change in any of the dose groups.,"[{'ForeName': 'Mark Krogh', 'Initials': 'MK', 'LastName': 'Hvistendahl', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rahim Mohammad', 'Initials': 'RM', 'LastName': 'Naimi', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lotte Hahn', 'Initials': 'LH', 'LastName': 'Enevoldsen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan Lysgaard', 'Initials': 'JL', 'LastName': 'Madsen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fuglsang', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Palle Bekker', 'Initials': 'PB', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medical Gastroenterology and Hepatology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1767']
3591,32005277,Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I).,"AIMS


In acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sleep-disordered breathing (SDB) is associated with reduced myocardial salvage index (MSI) within the first 3 months after AMI. Adaptive servo-ventilation (ASV) can effectively treat both types of SDB (central and obstructive sleep apnoea). The Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I) will investigate the effects of ASV therapy, added to percutaneous coronary intervention (PCI) and optimal medical management of AMI, on myocardial salvage after AMI.
METHODS/DESIGN


TEAM ASV-I is a multicentre, randomised, parallel-group, open-label trial with blinded assessment of PCI outcomes. Patients with first AMI and successful PCI within 24 h after symptom onset and SDB (apnoea-hypopnoea index ≥ 15/h) will be randomised (1:1 ratio) to PCI and optimal medical therapy alone (control) or plus ASV (with stratification of randomisation by infarct location; left anterior descending (LAD) or no LAD lesion). The primary outcome is the MSI, assessed by cardiac magnetic resonance imaging. Key secondary outcomes are change of infarct size, left ventricular ejection fraction and B-type natriuretic peptide levels and disease-specific symptom burden at 12 weeks.
CONCLUSION


TEAM ASV-I will help to determine whether treatment of SDB with ASV in the acute phase after myocardial infarction contributes to more myocardial salvage and healing.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02093377. Registered on March 21, 2014.",2020,Sleep-disordered breathing (SDB) is associated with reduced myocardial salvage index (MSI) within the first 3 months after AMI.,['Patients with first AMI and successful PCI within 24\u2009h after symptom onset and SDB (apnoea-hypopnoea index ≥\u200915/h'],"['PCI and optimal medical therapy alone (control) or plus ASV', 'Adaptive servo-ventilation (ASV', 'percutaneous coronary intervention (PCI']","['Sleep-disordered breathing (SDB', 'change of infarct size, left ventricular ejection fraction and B-type natriuretic peptide levels and disease-specific symptom burden at 12\u2009weeks', 'MSI, assessed by cardiac magnetic resonance imaging', 'myocardial salvage index (MSI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4285752', 'cui_str': 'Adaptive support ventilation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.17045,Sleep-disordered breathing (SDB) is associated with reduced myocardial salvage index (MSI) within the first 3 months after AMI.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hetzenecker', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stadler', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Oldenburg', 'Affiliation': 'Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Okka W', 'Initials': 'OW', 'LastName': 'Hamer', 'Affiliation': 'Institut für Röntgendiagnostik, Universitätsklinikum Regensburg, Regensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Zentrum für klinische Studien, Biostatistics, Universitätsklinikum Regensburg, Regensburg, Germany.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Bruch', 'Affiliation': 'Klinik für Innere Medizin / Kardiologie, Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Seidel', 'Affiliation': 'Klinik für Innere Medizin / Kardiologie, Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Buchner', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arzt', 'Affiliation': 'Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg, Franz-Josef-Strauss-Allee 11, 93053, Regensburg, Germany. michael.arzt@ukr.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4091-z']
3592,32005280,"Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs: a study protocol of a randomized controlled trial.","BACKGROUND


Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas.
METHODS


A total of 136 adult partners of patients with incurable cancer will be included. Partners will be randomly assigned to the intervention group, which directly gets access to Oncokompas, or the waiting-list control group, which gets access to Oncokompas after three months. The primary outcome measure is caregiver burden. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement.
DISCUSSION


This study will result in evidence on the efficacy and cost-utility of Oncokompas among partners of patients with incurable cancer, which might lead to implementation of Oncokompas as a health service for partners of patients with incurable cancer.
TRIAL REGISTRATION


Netherlands Trial Register, NTR 7636. Registered on 23 November 2018.",2020,"Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences.","['patients with incurable cancer', '136 adult partners of patients with incurable cancer', 'partners of patients with incurable cancer']","[""eHealth self-management application 'Oncokompas""]","['Efficacy and cost-utility', 'caregiver burden', 'self-efficacy, health-related quality of life, and costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",136.0,0.116372,"Oncokompas is an eHealth self-management application to support partners in finding and obtaining optimal supportive care, tailored to their quality of life and personal preferences.","[{'ForeName': 'Anouk S', 'Initials': 'AS', 'LastName': 'Schuit', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Holtmaat', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Hooghiemstra', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Jansen', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Veerle M H', 'Initials': 'VMH', 'LastName': 'Coupé', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. im.verdonck@amsterdamumc.nl.'}]",Trials,['10.1186/s13063-019-4037-5']
3593,32024741,"Providing Stroke and Hypertension Education in Amharic for Ethiopian Persons Living in Dallas, Texas, United States.","BACKGROUND


The purpose of this study was to compare knowledge of a stroke education module provided to bilingual members of the Ethiopian immigrant population in Dallas, Texas, presented in the Amharic language as compared to in English.
METHODS


A convenience sample of 84 participants were recruited using a snowball technique and randomly assigned to receive education in English or Amharic. The participants completed a pre- and posttest of their knowledge about strokes, a demographic survey, and a satisfaction survey. Data was analyzed using a general linear model and chi-square analysis.
RESULTS


There were no statistically significant differences between satisfaction scores comparing those educated in Amharic versus English (χ 2  = 6.5108,  p  = .0107). Although mean pretest (10.8) and posttest (16.4) stroke knowledge scores were higher across all groups ( p  < .001), the mean posttest scores were lower for subjects who watched the Amharic versus the English video (14.9 vs. 18.1,  p  = .003).
CONCLUSION


This study did not show a statistically significant increase in knowledge about stroke when presented learning materials in subjects' native language compared to in English. The use of video to present stroke and stroke-risk educational content can be used in future research and global health initiatives to increase stroke knowledge in the Amharic-speaking community.",2020,"Although mean pretest (10.8) and posttest (16.4) stroke knowledge scores were higher across all groups ( p  < .001), the mean posttest scores were lower for subjects who watched the Amharic versus the English video (14.9 vs. 18.1,  p  = .003).
","['bilingual members of the Ethiopian immigrant population in Dallas, Texas, presented in the Amharic language as compared to in English', '84 participants were recruited using a']",['snowball technique and randomly assigned to receive education in English or Amharic'],"['stroke knowledge scores', 'knowledge about stroke', 'satisfaction scores', 'mean posttest scores']","[{'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0162874', 'cui_str': 'Amharic language (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",84.0,0.0539443,"Although mean pretest (10.8) and posttest (16.4) stroke knowledge scores were higher across all groups ( p  < .001), the mean posttest scores were lower for subjects who watched the Amharic versus the English video (14.9 vs. 18.1,  p  = .003).
","[{'ForeName': 'Mehari', 'Initials': 'M', 'LastName': 'Gebreyohanns', 'Affiliation': ''}, {'ForeName': 'Chiamaka C', 'Initials': 'CC', 'LastName': 'Onuigbo', 'Affiliation': ''}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': ''}, {'ForeName': 'Sonja E', 'Initials': 'SE', 'LastName': 'Stutzman', 'Affiliation': ''}, {'ForeName': 'DaiWai M', 'Initials': 'DM', 'LastName': 'Olson', 'Affiliation': ''}]",Creative nursing,['10.1891/1078-4535.26.1.66']
3594,32024744,The Effect of Concept Mapping on Critical Thinking of Jordanian Nursing Students.,"AIM


The aim of this study was to explore the effectiveness of concept maps in improving the critical thinking of nursing students.
METHOD


This quasi-experimental study was conducted using a pretest-posttest design among two groups of a total of 115 nursing students. Participants were either exposed to concept mapping sessions or taught with traditional lecturing; the assessment tool was a test of critical thinking completed before and after the intervention.
RESULTS


The mean scores for critical thinking were higher in the group that engaged in mapping sessions compared to the traditional lecture group.
CONCLUSION


This study supports the usefulness of concept maps as a teaching strategy to promote development of nursing students' critical thinking abilities. These findings could provide valuable evidence for establishing concept mapping as a promising teaching strategy for nursing students.",2020,"The mean scores for critical thinking were higher in the group that engaged in mapping sessions compared to the traditional lecture group.
","['two groups of a total of 115 nursing students', 'Jordanian Nursing Students', 'nursing students']","['Concept Mapping', 'concept mapping sessions or taught with traditional lecturing']",['mean scores for critical thinking'],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279941', 'cui_str': 'Critical Thinking'}]",115.0,0.018827,"The mean scores for critical thinking were higher in the group that engaged in mapping sessions compared to the traditional lecture group.
","[{'ForeName': 'Huthaifah', 'Initials': 'H', 'LastName': 'Khrais', 'Affiliation': ''}, {'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Saleh', 'Affiliation': ''}]",Creative nursing,['10.1891/1078-4535.26.1.e19']
3595,32024972,A novel standardized test system to evaluate dynamic visual acuity post trifocal or monofocal intraocular lens implantation: a multicenter study.,"OBJECTIVES


To compare the dynamic visual acuity (DVA) following implantation of trifocal with monofocal intraocular lenses (IOL) and using a novel test system.
METHODS


The present research was a retrospective, multicenter clinical study. Two hundred and ten eyes of 149 patients that underwent cataract phacoemulsification and IOL implantation were enrolled. One hundred and ten eyes of patients received trifocal (AT LISA tri839MP, Carl Zeiss Meditec, Germany) and 100 eyes received monofocal (Tecnis ZCB00, Abbott, United States) lenses and were evaluated 3 months after implantation. Outcome measures included monocular uncorrected distance (UDVA), intermediate (UIVA) and near (UNVA) visual acuity and best corrected distance visual acuity (BCDVA; logMAR units); contrast sensitivity under photopic, mesopic, with glare conditions; and dynamic visual acuity using a self-developed system.
RESULTS


There was no statistically significant difference in baseline characteristics between groups. Monocular UDVA, UIVA, and UNVA were significantly better (all p < 0.001) in the trifocal IOL group, but not BCDVA. The trifocal IOL group showed better contrast sensitivity under photopic, mesopic, with or without glare conditions (p < 0.05) and statistically significantly better dynamic vision at 15, 30, 60, and 90 degrees per second (dps) compared with the monofocal group (all p < 0.001). The strength of positive association only between UIVA and dynamic visual acuity increased as the velocity increased, but not UDVA or UNVA.
CONCLUSIONS


Diffractive trifocal IOL provides better postoperative full range vision acuity, contrast sensitivity, and dynamic vision compared with monofocal IOLs. And intermediate visual acuity is increasingly associated with DVA as the velocity increasing.",2020,"Monocular UDVA, UIVA, and UNVA were significantly better (all p < 0.001) in the trifocal IOL group, but not BCDVA.","['Two hundred and ten eyes of 149 patients that underwent cataract phacoemulsification and IOL implantation were enrolled', 'One hundred and ten eyes of patients received trifocal (AT LISA tri839MP, Carl Zeiss Meditec, Germany) and 100 eyes received']","['implantation of trifocal with monofocal intraocular lenses (IOL', 'monofocal (Tecnis ZCB00, Abbott, United States) lenses', 'dynamic visual acuity post trifocal or monofocal intraocular lens implantation']","['dynamic visual acuity (DVA', 'contrast sensitivity under photopic, mesopic, with or without glare conditions', 'Monocular UDVA, UIVA, and UNVA', 'dynamic vision', 'monocular uncorrected distance (UDVA), intermediate (UIVA) and near (UNVA) visual acuity and best corrected distance visual acuity (BCDVA; logMAR units); contrast sensitivity under photopic, mesopic, with glare conditions; and dynamic visual acuity using a self-developed system', 'postoperative full range vision acuity, contrast sensitivity, and dynamic vision', 'strength of positive association only between UIVA and dynamic visual acuity']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1275646', 'cui_str': 'Trifocals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1275646', 'cui_str': 'Trifocals'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C3887688', 'cui_str': 'Glare (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",210.0,0.116298,"Monocular UDVA, UIVA, and UNVA were significantly better (all p < 0.001) in the trifocal IOL group, but not BCDVA.","[{'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Dengting', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Gansu Province Hospital Rehabilitation Center, Gansu, China.'}, {'ForeName': 'Baohua', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Lanzhou Bright Eye Hospital, Gansu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Chengdu Aier Eye Hospital, Sichuan, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Hebei Eye Hospital, Hebei, China.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Hebei Eye Hospital, Hebei, China.'}, {'ForeName': 'Xuemin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China. 13911254862@163.com.'}]","Eye (London, England)",['10.1038/s41433-020-0780-9']
3596,32023809,The Effects of Cholecalciferol Supplementation on Vitamin D Status Among a Diverse Population of Collegiate Basketball Athletes: A Quasi-Experimental Trial.,"Vitamin D may play a role in performance and injury risk, yet the required supplementation dosage for collegiate athletes is unclear. The objective of this study was to define the dosage of vitamin D 3  supplementation required to beneficially affect serum 25-hydroxyvitamin D (25(OH)D) among a sample of collegiate basketball athletes. This was a quasi-experimental trial, participants were allocated to one of three groups of vitamin D 3  daily at the beginning of pre-season training and dependent upon their baseline vitamin D status as follows: insufficient (<75 nmol/L) to 10,000 IU, sufficient (75-125 nmol/L) to 5000 IU and optimal (>125 nmol/L) to no supplementation. Follow-up assessments were completed ~ 5 months later in post season. The majority ( n  = 13) were allocated to 10,000 IU vs.  n  = 5 to 5000 IU and  n  = 2 to no supplementation. The 10,000 IU group showed the greatest change (35.0 ± 27.0 nmol/L) vs. the 5000 IU group (-9.3 ± 9.6 nmol/L) and no supplementation group (-41.6 ± 11.7 nmol/L,  p  < 0.01). Only 1 participant reached optimal status in the 10,000 IU group. In conclusion, a daily dosage of 10,000 IU vitamin D 3  supplementation mitigated the high prevalence of vitamin D deficiency among collegiate basketball players but was insufficient for all to reach sufficient levels.",2020,"The 10,000 IU group showed the greatest change (35.0 ± 27.0 nmol/L) vs. the 5000 IU group (-9.3 ± 9.6 nmol/L) and no supplementation group (-41.6 ± 11.7 nmol/L,  p  < 0.01).","['collegiate basketball athletes', 'a Diverse Population of Collegiate Basketball Athletes']","['vitamin D 3  daily at the beginning of pre-season training', 'Cholecalciferol Supplementation', 'Vitamin D', 'vitamin D 3  supplementation']","['Vitamin D Status', 'vitamin D deficiency', 'serum 25-hydroxyvitamin D (25(OH)D']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",13.0,0.0422701,"The 10,000 IU group showed the greatest change (35.0 ± 27.0 nmol/L) vs. the 5000 IU group (-9.3 ± 9.6 nmol/L) and no supplementation group (-41.6 ± 11.7 nmol/L,  p  < 0.01).","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Sekel', 'Affiliation': 'Department of Nutrition and Food Studies, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Department of Nutrition and Food Studies, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fields', 'Affiliation': 'Frank Pettrone Center for Sports Performance, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Jagim', 'Affiliation': 'Sport Medicine Research, Mayo Clinic Health Systems, Onalaska, WI 54650, USA.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': 'Department of Nutrition and Food Studies, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Margaret T', 'Initials': 'MT', 'LastName': 'Jones', 'Affiliation': 'Frank Pettrone Center for Sports Performance, George Mason University, Fairfax, VA 22030, USA.'}]",Nutrients,['10.3390/nu12020370']
3597,32011196,"Autologous activated platelet-rich plasma (AA-PRP) and non-activated (A-PRP) in hair growth: a retrospective, blinded, randomized evaluation in androgenetic alopecia.","Objectives : A retrospective case-series study comparing autologous activated platelet-rich plasma (AA-PRP) versus autologous non-activated platelet-rich plasma (A-PRP) in hair re-growth was reported. Methods : 90 patients, 63 males showing AGA in stage I-V by the Norwood-Hamilton scale and 27 females with AGA in stage I-III by the Ludwig scale, treated since 2013, were analyzed. 57 patients were treated with A-PRP injections and 33 patients were treated with AA-PRP in three sessions spaced 30 days average. Assessment of hair re-growth was evaluated in different weeks (Ws) after the treatment, summarized in four phases: T0, before the first infusion, T1 - 12 Ws, T2 - 23 Ws, T3 - 44 Ws, T4 - 58 Ws after the last treatment. Results : 12 Ws, 23 Ws, 44 Ws, and 58Ws after the last treatment, hair density measurements for patients treated with A-PRP and AA-PRP were 65 ± 5 and 28 ± 4 hairs/cm2 at T1, 28 ± 2 and 15 ± 3 hairs/cm2 at T2, 25 ± 3 and 14 ± 3 hairs/cm2 at T3, 23 ± 3 and 13 ± 3 hairs/cm 2  at T4. Conclusion : The effects of A-PRP and AA-PRP in hair re-growth during a long-term follow-up, was demonstrated.",2020,"A retrospective case-series study comparing autologous activated platelet-rich plasma (AA-PRP) versus autologous non-activated platelet-rich plasma (A-PRP) in hair re-growth was reported.
","['90 patients, 63 males showing AGA in stage I-V by the Norwood-Hamilton scale and 27 females with AGA in stage I-III by the Ludwig scale, treated since 2013, were analyzed', 'Hair Growth', '57 patients were treated with']","['autologous activated platelet-rich plasma (AA-PRP) versus autologous non-activated platelet-rich plasma (A-PRP', 'Autologous Activated Platelet-Rich Plasma (AA-PRP) and Non-activated (A-PRP', 'AA-PRP', 'A-PRP injections', 'PRP and AA-PRP']","['Assessment of hair re-growth', 'hair density measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",57.0,0.0243056,"A retrospective case-series study comparing autologous activated platelet-rich plasma (AA-PRP) versus autologous non-activated platelet-rich plasma (A-PRP) in hair re-growth was reported.
","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Gentile', 'Affiliation': 'Department of Surgical Sciences, Plastic and Reconstructive Surgery, University of Rome ""Tor Vergata"" School of Medicine, Rome, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Garcovich', 'Affiliation': 'Institute of Dermatology, F. Policlinico Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",Expert opinion on biological therapy,['10.1080/14712598.2020.1724951']
3598,29924506,Clinical Predictors of Extrapyramidal Symptoms Associated With Aripiprazole Augmentation for the Treatment of Late-Life Depression in a Randomized Controlled Trial.,"OBJECTIVE


Augmentation with aripiprazole is an effective pharmacotherapy for treatment-resistant late-life depression (LLD). However, aripiprazole can cause extrapyramidal symptoms (EPS) such as akathisia and parkinsonism; these symptoms are distressing and can contribute to treatment discontinuation. We investigated the clinical trajectories and predictors of akathisia and parkinsonism in older patients receiving aripiprazole augmentation for treatment-resistant LLD.
METHODS


Between 2009 and 2013, depressed older adults who did not remit with venlafaxine were randomized to aripiprazole or placebo in a 12-week trial. Participants were 60 years or older and met DSM-IV-TR criteria for major depressive episode with at least moderate symptoms. The presence of akathisia and parkinsonism was measured at each visit using the Barnes Akathisia Scale (BAS) and Simpson-Angus Scale (SAS), respectively. In an exploratory analysis, we examined a broad set of potential clinical predictors and correlates: age, sex, ethnicity, weight, medical comorbidity, baseline anxiety severity, depression severity, concomitant medications including rescue medications, and aripiprazole dosage.
RESULTS


Twenty-four (26.7%) of 90 participants randomized to aripiprazole and who had akathisia scores available developed akathisia compared to 11 (12.2%) of 90 randomized to placebo. Greater depression severity was the main predictor of treatment-emergent akathisia. Most participants who developed akathisia improved over time, especially with reductions in dosage. Fifteen (16.5%) of 91 participants taking aripiprazole and who had parkinsonism scores available developed parkinsonism, but no clinical predictors or correlates were identified.
CONCLUSIONS


Akathisia is a common side effect of aripiprazole, but it is typically mild and responds to dose reduction. Patients with greater baseline depression may warrant closer monitoring for akathisia. More research is needed to understand the course and predictors of treatment-emergent EPS with antipsychotic augmentation for treatment-resistant LLD.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00892047.",2018,"The presence of akathisia and parkinsonism was measured at each visit using the Barnes Akathisia Scale (BAS) and Simpson-Angus Scale (SAS), respectively.","['Twenty-four (26.7%) of 90 participants randomized to', 'older patients receiving aripiprazole augmentation for treatment-resistant LLD', 'Participants were 60 years or older and met DSM-IV-TR criteria for major depressive episode with at least moderate symptoms', 'Between 2009 and 2013, depressed older adults who did not remit with']","['Aripiprazole Augmentation', 'placebo', 'aripiprazole or placebo', 'venlafaxine', 'aripiprazole dosage', 'aripiprazole']","['Barnes Akathisia Scale (BAS) and Simpson-Angus Scale (SAS', 'akathisia scores available developed akathisia', 'akathisia and parkinsonism', 'akathisia', 'Greater depression severity']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]","[{'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",90.0,0.0334776,"The presence of akathisia and parkinsonism was measured at each visit using the Barnes Akathisia Scale (BAS) and Simpson-Angus Scale (SAS), respectively.","[{'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Hsu', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Healthy Mind Laboratory, Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Sanches', 'Affiliation': 'Campbell Family Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Late-Life Mood Disorders Clinic, Centre for Addiction and Mental Health, 1001 Queen St W, Unit 4, Room 115, Toronto, ON M6J 1H4. daniel.blumberger@camh.ca.'}]",The Journal of clinical psychiatry,['10.4088/JCP.17m11764']
3599,29931447,"The association between weight maintenance and session-by-session diet adherence, weight loss and weight-loss satisfaction.","OBJECTIVE


The aim of this study was to assess the association between weight-loss maintenance and weight-loss satisfaction, adherence to diet and weight loss, all measured session-by-session during the weight-loss phase of cognitive behavioral therapy.
METHODS


The present exploratory study examined a subgroup of fifty-eight patients who participated in a randomized controlled trial and who lost at least the 10% of their baseline weight. Patients were grouped into weight-loss 'Maintainers' (i.e., those who maintained a weight loss of ≥ 10% of baseline body weight at 6 months after the weight-loss phase) and 'Regainers' (i.e., those who did not maintain > 10% weight loss at 6 months after the weight-loss phase). Body weight, adherence to diet and weight-loss satisfaction were measured session-by-session during the weight-loss phase.
RESULTS


Thirteen patients (22.4%) were classified as 'Regainers', and 45 (77.6%) as 'Maintainers'. Compared to 'Maintainers', 'Regainers' had a lower adherence to diet after the initial 11 weeks, and a progressively declining weight loss and weight-loss satisfaction from week 15 or 19 of the weight-loss phase. 11-week dietary adherence and 15-week weight loss were significantly associated with weight maintenance. Similar results were obtained using the amount of weight change as dependent variable.
CONCLUSIONS


Adherence to diet, weight loss and weight-loss satisfaction, measured during the late weight-loss phase, are associated with weight-loss maintenance.
LEVEL OF EVIDENCE


Level III, evidence obtained from well-designed cohort or case-control analytical studies.",2020,"Compared to 'Maintainers', 'Regainers' had a lower adherence to diet after the initial 11 weeks, and a progressively declining weight loss and weight-loss satisfaction from week 15 or 19 of the weight-loss phase.","[""Patients were grouped into weight-loss 'Maintainers' (i.e., those who maintained a weight loss of ≥\u200910% of baseline body weight at 6\xa0months after the weight-loss phase) and 'Regainers' (i.e., those who did not maintain\u2009>\u200910% weight loss at 6\xa0months after the weight-loss phase"", 'subgroup of fifty-eight patients who participated in a randomized controlled trial and who lost at least the 10% of their baseline weight']",[],"['weight loss and weight-loss satisfaction', '11-week dietary adherence and 15-week weight loss', 'Body weight, adherence to diet and weight-loss satisfaction', 'weight-loss maintenance and weight-loss satisfaction, adherence to diet and weight loss', 'weight change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",58.0,0.0189639,"Compared to 'Maintainers', 'Regainers' had a lower adherence to diet after the initial 11 weeks, and a progressively declining weight loss and weight-loss satisfaction from week 15 or 19 of the weight-loss phase.","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Calugi', 'Affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital, Via Montebaldo, 89, 37016, Garda, VR, Italy. si.calugi@gmail.com.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Marchesini', 'Affiliation': 'Unit of Metabolic Diseases, S. Orsola-Malpighi Hospital, ""Alma Mater Studiorum"" University, Bologna, Italy.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'El Ghoch', 'Affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital, Via Montebaldo, 89, 37016, Garda, VR, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Gavasso', 'Affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital, Via Montebaldo, 89, 37016, Garda, VR, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Dalle Grave', 'Affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital, Via Montebaldo, 89, 37016, Garda, VR, Italy.'}]",Eating and weight disorders : EWD,['10.1007/s40519-018-0528-8']
3600,31996267,"Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough: protocol for a pilot, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Gastroesophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. Because the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD.
METHODS/DESIGN


This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After a 1-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n = 15) or a placebo group (n = 15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, which are the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analogue scale, the Leicester Cough Questionnaire (Korean version), the Gastrointestinal Symptom Rating Scale, the Hull Airway Reflux (hypersensitivity) Questionnaire, the Pattern Identification for Chronic Cough Questionnaire, the Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported.
DISCUSSION


This will be the first clinical trial to explore the use of herbal medicines for GERD-related chronic cough, including patients without GI reflux symptoms. This study will provide useful evidence regarding the efficacy and safety of Ojeok-san plus Saengmaek-san treatment. In addition, this trial will offer a scientific basis for the combination of herbal medicines. This study will also provide important data for conducting a larger-scale clinical trial on GERD-induced chronic cough.
TRIAL REGISTRATION


This trial has been registered with Clinical Research Information Service (CRIS) of South Korea (http://cris.nih.go.kr; registration number KCT0003115). Registered August 28, 2018.",2020,Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks.,"['gastroesophageal reflux-induced chronic cough', 'patients without GI reflux symptoms', '30 patients with GERD-induced chronic cough']","['herbal medicines', 'Ojeok-san plus Saengmaek-san treatment', 'placebo', 'Ojeok-san plus Saengmaek-san or a placebo', 'Ojeok-san plus Saengmaek-san']","['hypersensitivity) Questionnaire, the Pattern Identification for Chronic Cough Questionnaire, the Pattern Identification for Gastroesophageal Reflux Disease, and safety testing', 'Efficacy and safety', 'cough visual analogue scale, the Leicester Cough Questionnaire (Korean version), the Gastrointestinal Symptom Rating Scale, the Hull Airway Reflux', 'frequency and severity of cough, will be recorded using a cough diary']","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C3850922', 'cui_str': 'ojeok-san'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",30.0,0.481165,Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks.,"[{'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Bhang', 'Affiliation': 'Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Kwan-Il', 'Initials': 'KI', 'LastName': 'Kim', 'Affiliation': 'Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Jaehyo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Junmo', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Hwan-Su', 'Initials': 'HS', 'LastName': 'Jung', 'Affiliation': 'College of Korean Medicine, Sang-Ji University, 83 sangjidae-gil, Wonju-si, Ganwondo, 26339, Republic of Korea.'}, {'ForeName': 'Changsop', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Ko', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Bu', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Jae-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Kyoung Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Hee-Jae', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.'}, {'ForeName': 'Jun-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, 34054, Republic of Korea. omdjun@kiom.re.kr.'}, {'ForeName': 'Beom-Joon', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. franchisjun@naver.com.'}]",Trials,['10.1186/s13063-019-4030-z']
3601,32016644,Severely restricting energy intake for 24 h does not affect markers of bone metabolism at rest or in response to re-feeding.,"PURPOSE


Intermittent energy restriction commonly refers to ad libitum energy intake punctuated with 24 h periods of severe energy restriction. This can improve markers of metabolic health but the effects on bone metabolism are unknown. This study assessed how 24 h severe energy restriction and subsequent refeeding affected markers of bone turnover.
METHODS


In a randomised order, 16 lean men and women completed 2, 48 h trials over 3 days. On day 1, participants consumed a 24 h diet providing 100% [EB: 9.27 (1.43) MJ] or 25% [ER: 2.33 (0.34) MJ] of estimated energy requirements. On day 2, participants consumed a standardised breakfast (08:00), followed by an ad libitum lunch (12:00) and dinner (19:30). Participants then fasted overnight, returning on day 3. Plasma concentrations of C-terminal telopeptide of type I collagen (CTX), procollagen type 1 N-terminal propeptide (P1NP) and parathyroid hormone (PTH) were assessed as indices of bone metabolism after an overnight fast on days 1-3, and for 4 h after breakfast on day 2.
RESULTS


There were no differences between trials in fasting concentrations of CTX, P1NP or PTH on days 1-3 (P > 0.512). During both trials, consuming breakfast reduced CTX between 1 and 4 h (P < 0.001) and PTH between 1 and 2 h (P < 0.05), but did not affect P1NP (P = 0.773) Postprandial responses for CTX (P = 0.157), P1NP (P = 0.148) and PTH (P = 0.575) were not different between trials. Ad libitum energy intake on day 2 was greater on ER [12.62 (2.46) MJ] than EB [11.91 (2.49) MJ].
CONCLUSIONS


Twenty-four hour severe energy restriction does not affect markers of bone metabolism.",2020,"There were no differences between trials in fasting concentrations of CTX, P1NP or PTH on days 1-3 (P > 0.512).","['16 lean men and women completed 2, 48 h trials over 3\xa0days']",['EB'],"['bone metabolism', 'Postprandial responses for CTX', 'fasting concentrations of CTX, P1NP or PTH', 'Plasma concentrations of C-terminal telopeptide of type I collagen (CTX), procollagen type 1\xa0N-terminal propeptide (P1NP) and parathyroid hormone (PTH']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",[],"[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1101784', 'cui_str': 'COOH-terminal telopeptide of type I collagen'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}]",16.0,0.224437,"There were no differences between trials in fasting concentrations of CTX, P1NP or PTH on days 1-3 (P > 0.512).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, UK. david.clayton@ntu.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Sale', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham, NG11 8NS, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Varley', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, Nottingham, NG11 8NS, UK.'}]",European journal of nutrition,['10.1007/s00394-020-02186-4']
3602,31802570,"Feasibility, acceptability, and effectiveness of a multidisciplinary intervention in childhood obesity from primary care: Nutrition, physical activity, emotional regulation, and family.","Childhood obesity is a growing problem with a complex aetiology, for which multidisciplinary interventions are required. Our programme describes a novel structured psychosocial family-based intervention targeting the emotional regulation in childhood obesity, using a train trip metaphor aimed at improving healthy lifestyles for the family. The aims were (a) to describe the feasibility and acceptability of this psychosocial family-based intervention among children with overweight or obesity in primary care and (b) to examine the effectiveness of the ""ENTREN-F"" programme (with family intervention) compared with the ""ENTREN"" programme (without family intervention) among Spanish children regarding anthropometric variables, physical activity, emotional well-being, and family functioning. Children were randomly allocated to either ENTREN-F programme (n = 30) or psychological intervention for children (ENTREN, n = 40), and assessments were carried out over time (T 0  baseline vs. T 1  post/6-month vs. T 2  6-month follow-up). Both parent groups expressed high levels of satisfaction with the interventions. ENTREN-F resulted in higher adherence to treatment and was more effective in improving z-body mass index, reducing children's anxiety, and increasing family adaptability than the ENTREN programme. There were no significant changes in parents' emotional well-being and expressed emotion. Both groups improved in the children's emotional well-being and light physical activity. In summary, this multidisciplinary psychosocial family-based intervention was succesful.",2020,"ENTREN-F resulted in higher adherence to treatment and was more effective in improving z-body mass index, reducing children's anxiety, and increasing family adaptability than the ENTREN programme.","['children with overweight or obesity in primary care and (b', 'childhood obesity from primary care']","['multidisciplinary intervention', 'psychosocial family-based intervention', 'psychological intervention']","[""parents' emotional well-being and expressed emotion"", 'Feasibility, acceptability, and effectiveness', ""children's emotional well-being and light physical activity""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0144761,"ENTREN-F resulted in higher adherence to treatment and was more effective in improving z-body mass index, reducing children's anxiety, and increasing family adaptability than the ENTREN programme.","[{'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Sepúlveda', 'Affiliation': 'Department of Biological and Health Psychology, Faculty of Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Solano', 'Affiliation': 'Department of Biological and Health Psychology, Faculty of Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Blanco', 'Affiliation': 'Department of Biological and Health Psychology, Faculty of Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Lacruz', 'Affiliation': 'Department of Biological and Health Psychology, Faculty of Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Veiga', 'Affiliation': 'Department of Physical Education, Sport & Human Motricity, Autonomous University of Madrid, Madrid, Spain.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2702']
3603,32000803,Non-inferiority of cleavage-stage versus blastocyst-stage embryo transfer in poor prognosis IVF patients (PRECiSE trial): study protocol for a randomized controlled trial.,"BACKGROUND


With improvements in in vitro culture techniques there has been a steady shift in practice to transfer embryos at the blastocyst stage (post fertilization day (p.f.d.) 5-7), when embryos reach the endometrial cavity during natural conception. For patients with > 5 zygotes on day 1 of embryo development, fresh blastocyst embryo transfer (ET) increases live birth rates when compared to cleavage stage (p.f.d. 3) transfer. In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage. However, there is a dearth of randomized controlled trial (RCT) data demonstrating improved live birth rates per cycle for cleavage vs blastocyst stage ET in this subgroup of patients. The hypothesis of the PRECiSE (PooR Embryo Yield Cleavage Stage Versus blaStocyst Embryo Transfer) trial is that blastocyst ET is not inferior to cleavage stage ET with regard to live birth rates per retrieval in poorer prognosis patients. The adoption of routine blastocyst culture for all patients would result in higher rates of single embryo transfers (SET), reduced incidence of multiple pregnancies and simplified laboratory protocols, thereby reducing costs.
METHODS/DESIGN


Multicenter, non-inferiority randomized controlled trial (RCT) comparing blastocyst to cleavage stage embryo transfer in poorer prognosis patients with ≤5 zygotes on day 1 after fertilization. The primary outcome is live birth per retrieval. Secondary outcomes include: time to pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage and multiple pregnancy rate (per retrieval). This trial will enroll 658 women with ≤5 zygotes on day 1 at 6 IVF centers over the course of 22 months.
DISCUSSION


If the hypothesis is proven true, the data from this trial may facilitate the adoption of uniform blastocyst culture in all IVF patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03764865. Registered 5 December 2019, Protocol issue date: 4 December 2018, Original.",2020,In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage.,"['poor prognosis IVF patients (PRECiSE trial', 'poorer prognosis patients with ≤5 zygotes on day 1 after fertilization', '658 women with ≤5 zygotes on day 1 at 6 IVF centers over the course of 22\u2009months']",['cleavage-stage versus blastocyst-stage embryo transfer'],"['live birth rates', ' time to pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage and multiple pregnancy rate (per retrieval', 'live birth per retrieval', 'embryo development, fresh blastocyst embryo transfer (ET) increases live birth rates']","[{'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0686873', 'cui_str': 'Zygote of kingdom Protozoa (organism)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0013936', 'cui_str': 'Embryonic Development'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",658.0,0.368994,In poorer prognosis patients (≤ 5 zygotes) cleavage stage ET is commonly performed to reduce the risk of cycle cancellation if no embryo survives to the blastocyst stage.,"[{'ForeName': 'Werner M', 'Initials': 'WM', 'LastName': 'Neuhausser', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA. wneuhaus@bidmc.harvard.edu.'}, {'ForeName': 'Denis A', 'Initials': 'DA', 'LastName': 'Vaughan', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Denny', 'Initials': 'D', 'LastName': 'Sakkas', 'Affiliation': 'Boston IVF, Waltham, MA, USA.'}, {'ForeName': 'Michele R', 'Initials': 'MR', 'LastName': 'Hacker', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Toth', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Penzias', 'Affiliation': 'Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",Reproductive health,['10.1186/s12978-020-0870-y']
3604,32000820,"Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial.","BACKGROUND


Preterm birth accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. For a singleton pregnancy, progesterone treatment is effective in prevention of preterm birth in women with an asymptomatic short cervix or a history of preterm birth. However, a large proportion of preterm births still is not currently preventable. The aim of this study is to determine whether early universal use of oral progesterone before 14 + 0 weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy.
METHODS


This is a multicenter, randomized, double-blind, placebo-controlled trial registered with ClinicalTrials.gov on 12 February 2018. Eligible consecutive pregnant women with singleton gestation attending antenatal outpatient clinics will be recruited after receiving counseling and signing the written consent form. Transvaginal cervical length measurement will be performed at recruitment (before 14 + 0 weeks of gestation) and between 18 + 0 and 23 + 6 weeks of gestation. After randomization, women will be randomly assigned to either the treatment group (oral dydrogesterone 10 mg three times daily) or the placebo group, and medication will be started before 14 + 0 weeks of gestation. Assigned groups will be unblinded if the cervical length is ≤ 25 mm between 18 + 0 and 23 + 6 weeks of gestation, and the management option for short cervix will be discussed (oral progesterone, vaginal progesterone, or cervical cerclage). The primary outcome is preterm birth before 37 + 0 weeks of gestation.
DISCUSSION


Progesterone is used extensively in part of the in vitro fertilization program as luteal phase support, and it is not associated with teratogenicity. Universal progesterone supplementation may be a better approach to prevent preterm birth. This large, multicenter, randomized, double-blind, placebo-controlled trial will provide the best evidence, leading to the best strategy for the prevention of preterm birth.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03428685. Registered on 12 February 2018.",2020,"weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy.
","['12 February 2018', 'women with an asymptomatic short cervix or a history of preterm birth', 'preterm births in singleton pregnancy (SINPRO study', 'Eligible consecutive pregnant women with singleton gestation attending antenatal outpatient clinics']","['cervical length is ≤\u200925\u2009mm between 18\u2009+\u20090 and 23\u2009+\u20096\u2009weeks of gestation, and the management option for short cervix will be discussed (oral progesterone, vaginal progesterone, or cervical cerclage', 'dydrogesterone', 'oral progesterone', 'placebo', 'progesterone treatment', 'oral progesterone before 14\u2009+\u20090', 'Universal progesterone supplementation', 'Progesterone']","['Transvaginal cervical length measurement', 'preterm birth before 37\u2009+\u20090']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C3853999', 'cui_str': 'Cervical cerclage (physical object)'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C1956055', 'cui_str': 'Cervical Length Measurement'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",,0.789959,"weeks of gestation can prevent preterm birth better than universal screening of cervical length at 18 + 0 to 23 + 6 weeks of gestation, followed by progesterone treatment in those with a short cervix in singleton pregnancy.
","[{'ForeName': 'Ka Wang', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics and Gynaecology, Queen Mary Hospital, University of Hong Kong, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, Hong Kong Special Administration Region, China. kelvincheung82@hotmail.com.'}, {'ForeName': 'Mimi Tin Yan', 'Initials': 'MTY', 'LastName': 'Seto', 'Affiliation': 'Department of Obstetrics and Gynaecology, Queen Mary Hospital, University of Hong Kong, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, Hong Kong Special Administration Region, China.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynaecology, Queen Mary Hospital, University of Hong Kong, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, Hong Kong Special Administration Region, China.'}]",Trials,['10.1186/s13063-020-4067-z']
3605,32000828,Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial.,"BACKGROUND


Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency. Although the expected patency of SEMS is around 8 months, it has recently been reported that the duration of SEMS' patency in patients using aspirin is prolonged. Our study, therefore, aims to investigate the effect of aspirin on SEMS' patency.
METHODS/DESIGN


This is an investigator-initiated, prospective, multicenter, double-blind, randomized placebo-controlled trial that will be conducted from November 2017 in four tertiary centers in South Korea. We intend to include in our study 184 adult (aged ≥ 20 years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed. The patients will be randomly allocated to two groups, which will comprise patients who have either taken 100 mg aspirin or a placebo for 6 months after index ERBD. The primary outcome will be the rate of stent dysfunction, and the secondary outcomes will be the duration of patency, the rate of reintervention, and the occurrence of adverse events.
DISCUSSION


The aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study should determine the efficacy of aspirin in maintaining metal-stent patency in patients with malignant distal CBD obstructive.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03279809. Registered on 5 September 2017.",2020,"Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency.","['malignant distal common bile duct obstruction (AIMS', 'patients with malignant distal CBD obstructive', '184 adult (aged ≥ 20\u2009years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed', 'November 2017 in four tertiary centers in South Korea', 'patients with malignant distal common bile duct (CBD) obstruction']","['Endoscopic retrograde biliary drainage (ERBD', 'Self-expandable metal stents (SEMS', 'Aspirin', 'placebo', 'aspirin']","['rate of stent dysfunction', 'duration of patency, the rate of reintervention, and the occurrence of adverse events']","[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0009437', 'cui_str': 'Choledochus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage (procedure)'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metal Stents'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.573533,"Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency.","[{'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Paik', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea. whpaik@snuh.org.'}, {'ForeName': 'Min Su', 'Initials': 'MS', 'LastName': 'You', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyong Joo', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'Young Hoon', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bang-Sup', 'Initials': 'BS', 'LastName': 'Shin', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Kon', 'Initials': 'JK', 'LastName': 'Ryu', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yong-Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}]",Trials,['10.1186/s13063-020-4083-z']
3606,31919289,Multimodal Neurologic Enhancement Improves Preterm Infants' Developmental Outcomes: A Longitudinal Pilot Study.,"PURPOSE


The purpose of this study was to identify the long-term developmental effects of a NICU music therapy intervention, Multimodal Neurologic Enhancement, provided to preterm infants in the NICU.
DESIGN


Prospective randomized controlled study with one control group and one experimental group.
SAMPLE


Participants were medically stable preterm infants with a birth age of 31 and 6/7 weeks or less, admitted to a level-III NICU. A total of 84 participants were enrolled, and 48 completed the study.
MAIN OUTCOME VARIABLE


Post-discharge developmental scores on the  Mullen Scales of Early Learning: AGS Edition .
RESULTS


The experimental group performed significantly better than the control group on the Visual Reception and Early Learning Composite scores.",2020,The experimental group performed significantly better than the control group on the Visual Reception and Early Learning Composite scores.,"[""Preterm Infants' Developmental Outcomes"", 'preterm infants in the NICU', 'A total of 84 participants were enrolled, and 48 completed the study', 'SAMPLE\n\n\nParticipants were medically stable preterm infants with a birth age of 31 and 6/7 weeks or less, admitted to a level-III NICU']","['Multimodal Neurologic Enhancement', 'NICU music therapy intervention']","['Post-discharge developmental scores on the  Mullen Scales of Early Learning: AGS Edition ', 'Visual Reception and Early Learning Composite scores']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",84.0,0.0320725,The experimental group performed significantly better than the control group on the Visual Reception and Early Learning Composite scores.,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Detmer', 'Affiliation': ''}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Shina', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'DeLoach', 'Affiliation': ''}, {'ForeName': 'Johnathan R', 'Initials': 'JR', 'LastName': 'Malowitz', 'Affiliation': ''}]",Neonatal network : NN,['10.1891/0730-0832.39.1.16']
3607,32004437,Comparison of the Effect of Diclofenac 0.1% and Nepafenac 0.1% on Aqueous Flare in Patients Undergoing Cataract Surgery: A Prospective Randomized Study.,"OBJECTIVES


To compare, using laser flare meter (LFM), the efficacy of topical nepafenac 0.1, % and diclofenac 0.1% ophthalmic solution in the control of anterior chamber inflammation after uncomplicated cataract surgery.
METHODS


Patients undergoing phacoemulsification for age-related cataract were recruited. Complete evaluation with visual acuity, slit-lamp examination, endothelial cell density, intraocular pressure, retinal tomography and anterior chamber flare evaluation was performed before surgery and 1, 15, 30 and 60 days after surgery. Patients were randomly assigned to receive topical diclofenac 0.1% 4 times a day for four weeks or nepafenac 0.1% 3 times a day for three weeks in addition to topical steroids and antibiotic.
RESULTS


64 (31 males, mean age 77.3 ± 5.9) patients were enrolled. Half of them were randomly assigned to group A (diclofenac 0.1%) and half to group B (nepafenac 0.1%). There was a statistically significant visual acuity improvement postoperatively in both groups, with no statistical difference between the groups. Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters didn't significantly vary between before and after surgery. One-day after surgery, aqueous flare was significantly higher (22,27 ± 9,25 ph/ms in group A and 22,36 ± 7,47 in group B) than before surgery (14,59 ± 7,16 ph/ms in group A and 11,84 ± 4,44 in group B) in both groups, then declining in the first month and reaching preoperative levels again by 2 months in both groups. In group B, LFM values at 15 and 30 days after surgery were significantly lower (13,59 ± 4,80 and 14,07 ± 5,01) than in group A (17,00 ± 6,97 and 16,96 ± 6,13).
CONCLUSIONS


Nepafenac ensured a better inflammation control than diclofenac during the first month.",2020,"Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters didn't significantly vary between before and after surgery.","['Results : 64 (31 males, mean age 77.3 ± 5.9) patients were enrolled', 'anterior chamber inflammation after uncomplicated cataract surgery', 'Patients undergoing phacoemulsification for age-related cataract were recruited', 'Patients Undergoing Cataract Surgery']","['Diclofenac', 'Nepafenac', 'topical diclofenac', 'diclofenac', 'laser flare meter (LFM', 'diclofenac 0.1% ophthalmic solution', 'diclofenac 0.1%) and half to group B (nepafenac 0.1 ', 'nepafenac', 'topical nepafenac']","['aqueous flare', 'Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters', 'LFM values', 'visual acuity improvement', 'visual acuity, slit-lamp examination, endothelial cell density, intraocular pressure, retinal tomography and anterior chamber flare evaluation', 'inflammation control']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0524490', 'cui_str': 'Aqueous Flare'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0419360', 'cui_str': 'Slit Lamp Examination'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0320167,"Intraocular pressure, corneal thickness, endothelial cells count and macular thickness parameters didn't significantly vary between before and after surgery.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cagini', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pellegrino', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Cerquaglia', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Iaccheri', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lupidi', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}, {'ForeName': 'Tito', 'Initials': 'T', 'LastName': 'Fiore', 'Affiliation': 'Department of Biomedical and Surgical Sciences, Ophthalmology Section, University of Perugia , Perugia, Italy.'}]",Current eye research,['10.1080/02713683.2020.1725061']
3608,32006484,Baseline Characteristics of Participants in the Treatment of Advanced Glaucoma Study: A Multicenter Randomized Controlled Trial.,"PURPOSE


To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study).
DESIGN


Pragmatic randomized control trial (RCT).
METHODS


Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI).
RESULTS


A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA ""severe"" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3.
CONCLUSIONS


TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.",2020,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","['Four hundred and fifty-three patients were recruited', 'patients presenting with advanced open angle glaucoma in a publicly funded health service', 'Participants with newly diagnosed advanced glaucoma in at least one eye were recruited', 'participants in the Treatment of Advanced Glaucoma Study (TAGS', 'participants enrolled in the Treatment of Advanced Glaucoma Study (TAGS) DESIGN', 'Patients with open angle glaucoma presenting with advanced glaucoma in at least one eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria of severe defect']","['primary augmented trabeculectomy or primary medical management', 'TAGS']","['severe visual field mean deviation (MD', 'mean LogMAR visual acuity of the index eye', 'mean visual field MD', 'Visual field profile defined by the HPA classification, clinical characteristics, Quality of life measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3) and Glaucoma Profile Instrument (GPI']","[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C1828170', 'cui_str': 'Visual field index - mean deviation (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",453.0,0.352301,"Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB and nearly 90% had more than 20 points defective at the 1% level.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'Nottingham University Hospital, Nottingham, United Kingdom. Electronic address: anthony.king@nottingham.ac.uk.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Fernie', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Burr', 'Affiliation': 'University of St. Andrews, St. Andrews, Fife, United Kingdom.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Azuara-Blanco', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Sparrow', 'Affiliation': 'University Hospitals Bristol National Health Service Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Garway-Heath', 'Affiliation': 'Institute of Ophthalmology, University College London, London, United Kingdom; Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Kernohan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.01.026']
3609,30456414,PCNL in the prone position VS PCNL in the modified supine Double-S position: is there a better position? A prospective randomized trial.,"The study was performed to evaluate the efficacy of our modified supine position (called ""Double-S"") in percutaneous nephrolithotripsy (PCNL) and to make a contribution to the question: ""Is there a better position in PCNL?"". The superiority of one position is still under debate in the scientific community. In our study, we described and compared our position with the standard prone one to evaluate the possible benefits. This is a prospective randomized clinical trial conducted for 17 months. It consisted of two sub-studies: trial A (patients with stones approachable with a single anterograde access) and trial B (patients with stones approachable with a single anterograde access combined with a retrograde access). A 1:1 randomization was performed in both trials to compare the supine Double-S position with the prone one. We found that the Double-S position presents the same safety and efficacy outcomes as the standard prone one. Moreover, we proved that this particular position can reduce the patient positioning time and effort sustained by professional nurses if compared to the prone one. The same outcomes were found in trial A and in trial B. Trial B confirms the efficacy of our position also when a combined access is needed. We proved that the Double-S position is safe and effective both in anterograde treatments and in combined anterograde-retrograde procedures with benefits in the positioning time and effort level.",2020,The same outcomes were found in trial A and in trial B. Trial B confirms the efficacy of our position also when a combined access is needed.,['patients with stones approachable with a single anterograde access) and trial B (patients with'],"['PCNL', 'stones approachable with a single anterograde access combined with a retrograde access', 'percutaneous nephrolithotripsy (PCNL', 'modified supine position (called ""Double-S', 'Double-S position']",['safety and efficacy outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0589502', 'cui_str': 'Antegrade direction (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0666421,The same outcomes were found in trial A and in trial B. Trial B confirms the efficacy of our position also when a combined access is needed.,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giusti', 'Affiliation': 'Department of Urology, University of Cagliari, Via Is Mirrionis 92, 09121, Cagliari, Italy. giuseppegiusti.med@gmail.com.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'De Lisa', 'Affiliation': 'Department of Urology, University of Cagliari, Via Is Mirrionis 92, 09121, Cagliari, Italy.'}]",Urolithiasis,['10.1007/s00240-018-1088-0']
3610,32003520,Sleep coach intervention for teens with type 1 diabetes: Randomized pilot study.,"BACKGROUND


Teens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens.
OBJECTIVE


To evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention in teens with T1D.
RESEARCH DESIGN AND METHODS


Teens aged 13 to 17 with T1D (n = 39) completed measures of sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep. Hemoglobin A1C (HbA1c) was collected from medical records. Teens were randomized to Usual Care (n = 19) or the Sleep Coach intervention (n = 20). Teens in the Sleep Coach group received educational materials on healthy sleep habits and completed three individual telephone sessions. Follow-up data were collected at 3 months, including exit interviews with teens and parents.
RESULTS


Feasibility of the study was excellent; 80% of teens in the Sleep Coach group completed all three sessions, and retention was high (90%). Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants. No change in HbA1c was observed.
CONCLUSIONS


The Sleep Coach intervention for teens with T1D is a feasible and acceptable program that increased sleep duration and improved sleep quality for this high-risk population.",2020,"Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48 minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants.","['Teens aged 13-17 with T1D', 'teens with T1D', 'Teens with Type 1 Diabetes', 'Teens with type 1 diabetes (T1D) experience increased sleep disturbances']","['Sleep Coach Intervention', 'Usual Care', 'Sleep Coach intervention', 'sleep-promoting intervention', 'educational materials on healthy sleep habits and completed 3 individual telephone sessions']","['sleep duration and improved sleep quality', 'sleep quality', 'sleep efficiency and sleep duration', 'sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0236941,"Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48 minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hamburger', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Bergner', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Rodayne', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Malow', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee.'}]",Pediatric diabetes,['10.1111/pedi.12991']
3611,31973702,"The efficacy and safety of 'antianxiety granule' for anxiety disorder: a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial.","BACKGROUND


Anxiety disorders are the most prevalent class of lifetime disorders in China, and generalized anxiety disorder (GAD) is one of the most common but frequently overlooked anxiety disorders. Conventional pharmacological treatments for GAD have varying degrees of side effects, dependency, and/or withdrawal syndromes. Traditional Chinese medicine (TCM) is considered a valuable therapeutic option for anxiety disorders and a potentially effective technique to reduce the side effects associated with antipsychotic drugs. This trial aimed to evaluate the clinical efficacy and safety of Antianxiety Granule, a granular Chinese medicine compound, for treatment of GAD.
METHODS/DESIGN


The current work is a multicentre, randomized, double-blind, placebo-controlled, parallel-group clinical trial with a 6-week treatment schedule. The study consists of three periods: a 1-7-day screening period, a 6-week primary treatment period, and a 1-week follow-up period. Follow-up assessments will be conducted 1 week after the last visit with a face-to-face interview or by telephone. The clinical efficacy of Antianxiety Granule for the treatment of GAD will be evaluated by examining the change in the Hamilton anxiety scale (HAMA) score, state-trait anxiety inventory (STAI) score, and TCM symptom scale in patients with GAD who receive daily TCM treatment. Moreover, an intention-to-treat (ITT) analysis will also be used in this randomized controlled trial (RCT).
DISCUSSION


Our study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the safety and efficacy of Antianxiety Granule for the treatment of GAD. The results of this trial will provide valuable clinical evidence for the treatment of GAD.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800016039. Registered on 8 May 2018.",2020,"The clinical efficacy of Antianxiety Granule for the treatment of GAD will be evaluated by examining the change in the Hamilton anxiety scale (HAMA) score, state-trait anxiety inventory (STAI) score, and TCM symptom scale in patients with GAD who receive daily TCM treatment.","['patients with GAD who receive daily TCM treatment', 'anxiety disorder']","['antianxiety granule', 'placebo', 'Traditional Chinese medicine (TCM']","['safety and efficacy', 'Hamilton anxiety scale (HAMA) score, state-trait anxiety inventory (STAI) score, and TCM symptom scale', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.437093,"The clinical efficacy of Antianxiety Granule for the treatment of GAD will be evaluated by examining the change in the Hamilton anxiety scale (HAMA) score, state-trait anxiety inventory (STAI) score, and TCM symptom scale in patients with GAD who receive daily TCM treatment.","[{'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Sha', 'Affiliation': 'Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Chunchun', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': 'Pain Management Centre, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Li', 'Affiliation': 'Standardized Resident Training Staff, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. zwj1072@163.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Mental Diseases, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. xujian0296@163.com.'}]",Trials,['10.1186/s13063-020-4057-1']
3612,31366415,Intervening with Attachment and Biobehavioral Catch-Up to decrease disrupted parenting behavior and attachment disorganization: The role of parental withdrawal.,"This randomized controlled trial investigated the efficacy of Attachment and Biobehavioral Catch-up (ABC; Dozier, Bick, & Bernard, 2011) in reducing disrupted parenting behavior (affective communication errors, role/boundary confusion, fearful/disoriented, intrusive/negativity, and withdrawal) and its association with disorganized attachment. Participants were 105 mother-child dyads randomized to receive either ABC or a control intervention (a 10-session home-visiting intervention focused on improving children's cognitive abilities, gross and fine motor abilities, and language development). At the time of study enrollment, mothers were approximately 26.7 years old (SD = 7.8) and predominantly Black or African American (73.9%). At the first follow-up visit, children were approximately 20.7 months old (SD = 6.3) and most were identified as Black or African American (61.9%). Fifty-two percent of children were male (n = 55). Assessments of disrupted parenting behavior and child attachment quality were assessed approximately 7 months postintervention (SD = 5.8). A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition. A structural equation model revealed a significant indirect effect of intervention group on attachment quality through lower levels of parental withdrawal. Results add to the efficacy of the ABC intervention and identified parental withdrawal as a mediator of change.",2020,A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition.,"['Participants were 105 mother-child dyads', 'mothers were approximately 26.7 years old (SD = 7.8) and predominantly Black or African American (73.9', 'Fifty-two percent of children were male (n = 55']","['ABC intervention', ""ABC or a control intervention (a 10-session home-visiting intervention focused on improving children's cognitive abilities, gross and fine motor abilities, and language development"", 'Attachment and Biobehavioral Catch-up (ABC']","['disrupted parenting behavior and child attachment quality', 'parenting behavior and attachment disorganization']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",105.0,0.0318052,A one-way analysis of variance revealed that parents who received ABC demonstrated lower levels of parental withdrawal than parents who received the control condition.,"[{'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Yarger', 'Affiliation': 'Department of Psychology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Bronfman', 'Affiliation': ""Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Carlson', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, Newark, DE, USA.'}]",Development and psychopathology,['10.1017/S0954579419000786']
3613,31895303,"The Effect of Kangaroo Mother Care, Provided in the Early Postpartum Period, on the Breastfeeding Self-Efficacy Level of Mothers and the Perceived Insufficient Milk Supply.","The aim of this study was to determine the effect of kangaroo mother care, provided in the early postpartum period, on the breastfeeding self-efficacy level and the perceived insufficient milk supply. This study was conducted as the quasi-experimental design. The population of the study consisted of the mothers and their infants, to whom they gave birth in a university hospitals located in either eastern or western Turkey, between December 2016 and June 2017. In this study, mothers and their infants were randomly assigned to the experimental group (kangaroo mother care, n = 30) and the control group (n = 30). This study included 2500 to 4000 g birth weight infants who had no serious health problems and no sucking problems. The Introductory Information Form, the Breastfeeding Self-Efficacy Scale, and the Perception of Insufficient Milk Questionnaire were used to collect the data. In this study, kangaroo mother care was provided as a nursing intervention for the mothers in the experimental group twice a day until they were discharged. Any other application was not performed in the control group's mothers apart from the routine application. Ethical principles were adhered in all stages of the study. The breastfeeding self-efficacy mean score (65.50 ± 3.95) of the mothers who performed kangaroo mother care was higher than the mean score of the mothers who did not perform kangaroo mother care (55.50 ± 7.00) (P < .001). In addition, mothers in the experimental group (46.60 ± 3.40) perceived their milk more sufficiently than mothers in the control group (30.17 ± 11.37) (P < .001). In the study, a statistically significant correlation was determined between breastfeeding self-efficacy levels of mothers in the experimental group and the perceived insufficient milk supply (P < .05). In the study, kangaroo mother care increased breastfeeding self-efficacy perception of the mothers and reduced the perceived insufficient milk supply. This shows that kangaroo mother care can potentially have an important effect on breastfeeding perceptions.",2020,The breastfeeding self-efficacy mean score (65.50 ± 3.95) of the mothers who performed kangaroo mother care was higher than the mean score of the mothers who did not perform kangaroo mother care (55.50 ± 7.00),"['mothers and their infants', 'mothers and their infants, to whom they gave birth in a university hospitals located in either eastern or western Turkey, between December 2016 and June 2017', '2500 to 4000 g birth weight infants who had no serious health problems and no sucking problems']",[],"['breastfeeding self-efficacy perception', 'breastfeeding self-efficacy mean score', 'breastfeeding self-efficacy levels']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319601', 'cui_str': '2500 (qualifier value)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0677049', 'cui_str': 'Does suck (finding)'}]",[],"[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0179342,The breastfeeding self-efficacy mean score (65.50 ± 3.95) of the mothers who performed kangaroo mother care was higher than the mean score of the mothers who did not perform kangaroo mother care (55.50 ± 7.00),"[{'ForeName': 'Fatma Yılmaz', 'Initials': 'FY', 'LastName': 'Kurt', 'Affiliation': 'Department of Children Health and Diseases Nursing, Faculty of Nursing, Çanakkale Onsekiz Mart University, Turkey (Dr Yilmaz and Mr Oğul); Department of Children Health and Diseases Nursing, Faculty of Nursing, Selcuk University, Konya, Turkey (Dr Küçükoglu); Department of Nursing, Faculty of Health Sciences, Istanbul Medeniyet University, Istanbul, Turkey (Dr Aytekin Ozdemir); and Çanakkale Obstetrics and Gynecology Clinic, Health Practice and Research Hospital, Turkey (Ms Aski).'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Küçükoğlu', 'Affiliation': ''}, {'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Aytekin Özdemir', 'Affiliation': ''}, {'ForeName': 'Tanju', 'Initials': 'T', 'LastName': 'Oğul', 'Affiliation': ''}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Aşki', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000434']
3614,29084067,A Randomized Control Trial of Cardiopulmonary Feedback Devices and Their Impact on Infant Chest Compression Quality: A Simulation Study.,"OBJECTIVES


In effort to improve chest compression quality among health care providers, numerous feedback devices have been developed. Few studies, however, have focused on the use of cardiopulmonary resuscitation feedback devices for infants and children. This study evaluated the quality of chest compressions with standard team-leader coaching, a metronome (MetroTimer by ONYX Apps), and visual feedback (SkillGuide Cardiopulmonary Feedback Device) during simulated infant cardiopulmonary resuscitation.
METHODS


Seventy voluntary health care providers who had recently completed Pediatric Advanced Life Support or Basic Life Support courses were randomized to perform simulated infant cardiopulmonary resuscitation into 1 of 3 groups: team-leader coaching alone (control), coaching plus metronome, or coaching plus SkillGuide for 2 minutes continuously. Rate, depth, and frequency of complete recoil during cardiopulmonary resuscitation were recorded by the Laerdal SimPad device for each participant. American Heart Association-approved compression techniques were randomized to either 2-finger or encircling thumbs.
RESULTS


The metronome was associated with more ideal compression rate than visual feedback or coaching alone (104/min vs 112/min and 113/min; P = 0.003, 0.019). Visual feedback was associated with more ideal depth than auditory (41 mm vs 38.9; P = 0.03). There were no significant differences in complete recoil between groups. Secondary outcomes of compression technique revealed a difference of 1 mm. Subgroup analysis of male versus female showed no difference in mean number of compressions (221.76 vs 219.79; P = 0.72), mean compression depth (40.47 vs 39.25; P = 0.09), or rate of complete release (70.27% vs 64.96%; P = 0.54).
CONCLUSIONS


In the adult literature, feedback devices often show an increase in quality of chest compressions. Although more studies are needed, this study did not demonstrate a clinically significant improvement in chest compressions with the addition of a metronome or visual feedback device, no clinically significant difference in Pediatric Advanced Life Support-approved compression technique, and no difference between compression quality between genders.",2020,Visual feedback was associated with more ideal depth than auditory (41 mm vs 38.9; P = 0.03).,"['infants and children', 'Seventy voluntary health care providers who had recently completed Pediatric Advanced Life Support or Basic Life Support courses']","['Cardiopulmonary Feedback Devices', 'compression technique', 'standard team-leader coaching, a metronome (MetroTimer by ONYX Apps), and visual feedback (SkillGuide Cardiopulmonary Feedback Device', 'simulated infant cardiopulmonary resuscitation into 1 of 3 groups: team-leader coaching alone (control), coaching plus metronome, or coaching plus SkillGuide']","['ideal compression rate', 'Rate, depth, and frequency of complete recoil during cardiopulmonary resuscitation', 'rate of complete release', 'quality of chest compressions', 'mean number of compressions', 'mean compression depth', 'Visual feedback', 'complete recoil', 'Infant Chest Compression Quality']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support (procedure)'}, {'cui': 'C0085873', 'cui_str': 'Basic life support (procedure)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",70.0,0.11444,Visual feedback was associated with more ideal depth than auditory (41 mm vs 38.9; P = 0.03).,"[{'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Austin', 'Affiliation': 'From the Uniformed Services University of the Health Sciences, F. Edward Hébert School of Medicine, Bethesda, MD.'}, {'ForeName': 'Carmen N', 'Initials': 'CN', 'LastName': 'Spalding', 'Affiliation': 'Bioskills and Simulation Training Center.'}, {'ForeName': 'Katrina N', 'Initials': 'KN', 'LastName': 'Landa', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Myer', 'Affiliation': 'Simulation Training Center.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Cure', 'Affiliation': 'Department of Bioskills and Simulation Training, Naval Medical Center San Diego, San Diego, CA.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Platt', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Heather C', 'Initials': 'HC', 'LastName': 'King', 'Affiliation': 'From the Uniformed Services University of the Health Sciences, F. Edward Hébert School of Medicine, Bethesda, MD.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001312']
3615,32005286,Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda.,"BACKGROUND


There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in stabilised neonates; however, data on its effect among neonates before stabilisation are lacking. The OMWaNA trial aims to determine the effect of initiating KMC before stabilisation on mortality within seven days relative to standard care. Secondary objectives include exploring pathways for the intervention's effects and assessing incremental costs and cost-effectiveness between arms.
METHODS


We will conduct a four-centre, open-label, individually randomised, superiority trial in Uganda with two parallel groups: an intervention arm allocated to receive KMC and a control arm receiving standard care. We will enrol 2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥ 1 therapy (e.g. oxygen). Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥ 1 baby) weighing ≥ 700-≤ 2000 g and aged ≥ 1-< 48 h are eligible. Treatment allocation is random in a 1:1 ratio between groups, stratified by weight and recruitment site. The primary outcome is mortality within seven days. Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days. Primary analyses will be by intention-to-treat. Quantitative and qualitative data will be integrated in a process evaluation. Cost data will be collected and used in economic modelling.
DISCUSSION


The OMWaNA trial aims to assess the effectiveness of KMC in reducing mortality among neonates before stabilisation, a vulnerable population for whom its benefits are uncertain. The trial will improve understanding of pathways underlying the intervention's effects and will be among the first to rigorously compare the incremental cost and cost-effectiveness of KMC relative to standard care. The findings are expected to have broad applicability to hospitals in sub-Saharan Africa and southern Asia, where three-quarters of global newborn deaths occur, as well as important policy and programme implications.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02811432. Registered on 23 June 2016.",2020,"Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days.","['low birth Weight Neonates in Africa (OMWaNA', 'g and aged ≥', 'Uganda', 'Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥\u20091 baby) weighing ≥\u2009700-≤\u20092000', ""2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥\u20091 therapy (e.g. oxygen""]","['kangaroo mother care (KMC', 'Operationalising kangaroo Mother care before stabilisation', 'KMC and a control arm receiving standard care', 'KMC']","[""mortality within 28\u2009days, hypothermia prevalence at 24\u2009h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing"", 'mortality within seven\u2009days', 'incremental costs and cost-effectiveness between arms']","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",2188.0,0.257338,"Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Medvedev', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Melissa.Morgan@lshtm.ac.uk.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tumukunde', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Mambule', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Cally J', 'Initials': 'CJ', 'LastName': 'Tann', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Waiswa', 'Affiliation': 'Centre of Excellence for Maternal, Newborn, and Child Health, School of Public Health, Makerere University, New Mulago Hill Road, Kampala, Uganda.'}, {'ForeName': 'Ruth R', 'Initials': 'RR', 'LastName': 'Canter', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ekirapa-Kiracho', 'Affiliation': 'Centre of Excellence for Maternal, Newborn, and Child Health, School of Public Health, Makerere University, New Mulago Hill Road, Kampala, Uganda.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Katumba', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Pitt', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1E 7HT, UK.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Greco', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brotherton', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, PO Box 49, Entebbe, Uganda.'}, {'ForeName': 'Moffat', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Joy E', 'Initials': 'JE', 'LastName': 'Lawn', 'Affiliation': 'Maternal, Adolescent, Reproductive, & Child Health Centre, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",Trials,['10.1186/s13063-019-4044-6']
3616,31346900,"Comparison between two mathematical methods to estimate arterial occlusion pressure and tourniquet effectiveness in lower limb surgery: a prospective, randomized, double blind, comparative study.","The effectiveness of two different methods for calculating the arterial occlusion pressure (AOP) to set tourniquet inflation pressures were assessed in patients underwent knee arthroscopy. Eighty patients were included in this study. Tourniquet inflation pressure was set by adding 20 mmHg of safety margin above the AOP value which was calculated by either the Tuncali et al. formula or Hong-yun Liu et al. formula. Primary outcome measures were the initial and maximum SBP, initial and maximum tourniquet inflation pressure, the secondary outcomes were the surgeon rating of the bloodlessness of the surgical field and tourniquet associated complications. There was significant difference in the initial tourniquet pressure (mmHg); it was 208 ± 12 and 262 ± 18 for group (A) and (B) respectively; also there was significant difference in the maximum tourniquet pressure (mmHg), it was 229 ± 14 and 283 ± 19 for group (A) and (B) respectively. There was no significant difference in the initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP between the groups. Also, there was no significant difference in surgeon rating of the bloodlessness of the surgical field, at the start, middle and end of surgery. Hong-yun Liu et al. mathematical formula was found to be less effective than Tuncali et al. formula to estimate the least effective tourniquet pressure in lower limb surgery and we might consider it invalid to be used in the lower limb.Clinical trials registration number: NCT03706859 (Clinicaltrials.gov) and registration date: January, 2019. https://clinicaltrials.gov/ct2/show/NCT03706859.",2020,"There was no significant difference in the initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP between the groups.","['lower limb surgery', 'Eighty patients were included in this study', 'patients underwent knee arthroscopy']",['formula or Hong-yun'],"['arterial occlusion pressure (AOP', 'initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP', 'maximum tourniquet pressure', 'Tourniquet inflation pressure', 'surgeon rating', 'initial tourniquet pressure', 'initial and maximum SBP, initial and maximum tourniquet inflation pressure, the secondary outcomes were the surgeon rating of the bloodlessness of the surgical field and tourniquet associated complications', 'arterial occlusion pressure and tourniquet effectiveness']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}]",[],"[{'cui': 'C0264995', 'cui_str': 'Occlusion of artery (disorder)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0428725', 'cui_str': 'Tourniquet inflation pressure (observable entity)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",80.0,0.0620154,"There was no significant difference in the initial SBP-to- tourniquet inflation time, the initial SBP or the maximum SBP between the groups.","[{'ForeName': 'Samaa A', 'Initials': 'SA', 'LastName': 'Kasem', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Beni Suef University, Street 10, Pyramids gardens, Giza, Egypt. sama.a.kasem@gmail.com.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Al Menesy', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Beni Suef University, Street 10, Pyramids gardens, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Badawy', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abd Elmawgoud', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Adel', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Yasmin A', 'Initials': 'YA', 'LastName': 'Badawy', 'Affiliation': 'Faculty of Medicine, Cairo University, Giza, Egypt.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-019-00366-0']
3617,29793869,Extreme Preterm Infant Rates of Overweight and Obesity at School Age in the SUPPORT Neuroimaging and Neurodevelopmental Outcomes Cohort.,"OBJECTIVE


To identify rates of overweight (body mass index [BMI] ≥85th percentile) and obesity (BMI ≥95th percentile) at 6-7 years of age and associated risk factors among extremely preterm infants born at <28 weeks of gestation.
STUDY DESIGN


Anthropometrics, blood pressure, and active and sedentary activity levels were prospectively assessed. Three groups were compared, those with a BMI ≥85th percentile (overweight or obese for age, height, and sex) and ≥95th percentile (obese) vs <85th percentile. Multiple regression analyses estimated the relative risks of BMI ≥85th percentile and ≥95th percentile associated with perinatal and early childhood factors.
RESULTS


Of 388 children, 22% had a BMI of ≥85th percentile and 10% were obese. Children with obesity and overweight compared with normal weight children had higher body fat (subscapular skinfold and triceps skinfold >85th percentile), central fat (waist circumference >90th percentile), spent more time in sedentary activity (20.5 vs 18.2 vs 16.7 hours/week), and had either systolic and/or diastolic hypertension (24% vs 26% vs 14%), respectively. Postdischarge weight gain velocities from 36 weeks postmenstrual age to 18 months, and 18 months to 6-7 years were independently associated with a BMI of ≥85th percentile, whereas weight gain velocity from 18 months to 6-7 years was associated with obesity.
CONCLUSIONS


One in 5 former extremely preterm infants is overweight or obese and has central obesity at early school age. Postdischarge weight gain velocities were associated with overweight and obesity. These findings suggest the obesity epidemic is spreading to the most extremely preterm infants.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT00063063 and NCT0000.",2018,"Children with obesity and overweight compared with normal weight children had higher body fat (subscapular skinfold and triceps skinfold >85th percentile), central fat (waist circumference >90th percentile), spent more time in sedentary activity (20.5 vs 18.2 vs 16.7 hours/week), and had either systolic and/or diastolic hypertension (24% vs 26% vs 14%), respectively.","['Three groups were compared, those with a BMI ≥85th percentile (overweight or obese for age, height, and sex) and ≥95th percentile (obese) vs <85th percentile', 'extremely preterm infants born at\u2009<28 weeks of gestation', 'preterm infants is overweight or obese and has central obesity at early school age', 'Of 388 children, 22% had a BMI of ≥85th percentile and 10% were obese', 'Children with obesity and overweight compared with normal weight children']",[],"['Postdischarge weight gain velocities', 'weight gain velocity', 'systolic and/or diastolic hypertension', 'blood pressure, and active and sedentary activity levels', 'higher body fat (subscapular skinfold and triceps skinfold >85th percentile), central fat (waist circumference >90th percentile), spent more time in sedentary activity']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0235222', 'cui_str': 'Diastolic hypertension (disorder)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",388.0,0.038123,"Children with obesity and overweight compared with normal weight children had higher body fat (subscapular skinfold and triceps skinfold >85th percentile), central fat (waist circumference >90th percentile), spent more time in sedentary activity (20.5 vs 18.2 vs 16.7 hours/week), and had either systolic and/or diastolic hypertension (24% vs 26% vs 14%), respectively.","[{'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Division of Neonatal Medicine, Women & Infants Hospital and Alpert Medical School of Brown University, Providence, RI. Electronic address: bvohr@wihri.org.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Heyne', 'Affiliation': 'Department of Pediatrics, Division of Neonatal Medicine, UT Southwestern, Dallas, TX.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'Social Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': 'National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Hintz', 'Affiliation': ""Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2018.04.073']
3618,31973706,Preoperative pelvic floor muscle exercise for early continence after holmium laser enucleation of the prostate: a randomized controlled study.,"BACKGROUND


Transient postoperative urinary incontinence is a bothersome complication of holmium laser enucleation of the prostate (HoLEP). The effects of preoperative pelvic floor muscle exercise (PFME) for early recovery of continence after HoLEP have never been elucidated. The aim of this study was to determine the benefit of preoperatively started PFME for early recovery of continence after HoLEP.
METHODS


We randomly assigned patients to start PFME preoperatively and continue postoperatively (group A) or start PFME no earlier than the postoperative period (group B). The primary outcome was time to complete urinary control, defined as no pad usage. The secondary outcome was measured using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score. Univariate and multivariate analyses were performed to identify parameters associated with recovery of continence after HoLEP.
RESULTS


Seventy patients were randomized across groups A (n = 35) and B (n = 35). Patients' characteristics were not different between groups A and B. The postoperative urinary incontinence rate significantly decreased in group A compared with that in group B at 3 months postoperatively [3% vs. 26% (P = 0.01)]. However, there were no significant differences between groups A and B at 3 days [40% vs. 54% (P = 0.34)], 1 month [37% vs. 51% (P = 0.34)], and 6 months [0% vs. 3% (P = 1.00)] postoperatively, respectively. The postoperative ICIQ-SF score was not significantly different between groups A and B at any time point postoperatively. In univariate analysis, patients who performed preoperative PFME had a 0.56-fold lower risk of urinary incontinence 1 month after HoLEP and a 0.08-fold lower risk of urinary incontinence 3 months after HoLEP.
CONCLUSIONS


Preoperatively started PFME appears to facilitate improvement of early urinary continence after HoLEP.
TRIAL REGISTRATION


The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000034713); registration date: 31 October 2018. Retrospectively registered.",2020,The postoperative urinary incontinence rate significantly decreased in group A compared with that in group B at 3 months postoperatively [3% vs. 26% (P = 0.01)].,"['Seventy patients', 'The study was registered with the University Hospital Medical Information Network Clinical Trials Registry in Japan (UMIN000034713); registration date: 31 October 2018', 'early continence after holmium laser enucleation of the prostate']","['holmium laser enucleation', 'Preoperative pelvic floor muscle exercise', 'start PFME preoperatively and continue postoperatively (group A) or start PFME no earlier than the postoperative period', 'preoperative pelvic floor muscle exercise (PFME']","['time to complete urinary control, defined as no pad usage', 'postoperative ICIQ-SF score', 'International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score', 'postoperative urinary incontinence rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0633055', 'cui_str': 'PFME'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0542565', 'cui_str': 'Bladder control, function (observable entity)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]",70.0,0.136216,The postoperative urinary incontinence rate significantly decreased in group A compared with that in group B at 3 months postoperatively [3% vs. 26% (P = 0.01)].,"[{'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Anan', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan. goanan@tohoku-mpu.ac.jp.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kaiho', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Iwamura', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ito', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kohada', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan.'}, {'ForeName': 'Jotaro', 'Initials': 'J', 'LastName': 'Mikami', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan, 1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi, 983-8536, Japan.'}]",BMC urology,['10.1186/s12894-019-0570-5']
3619,31973713,Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism.,"BACKGROUND


Point OutWords is a caregiver-delivered, iPad-assisted intervention for non-verbal or minimally verbal children with autism. It aims to develop prerequisite skills for communication such as manual and oral motor skills, sequencing, and symbolic representation. This feasibility trial aims to determine the viability of evaluating the clinical efficacy of Point OutWords.
METHODOLOGY


We aim to recruit 46 non-verbal or minimally verbal children with autism and their families, approximately 23 per arm. Children in the intervention group will use Point OutWords for half an hour, five times a week, for 8 weeks. Children in the control group will have equal caregiver-led contact time with the iPad using a selection of control apps (e.g. sensory apps, drawing apps). Communication, motor, and daily living skills are assessed at baseline and post-intervention. Parents will keep diaries during the intervention period and will take part in focus groups when the intervention is completed.
DISCUSSION


Point OutWords was developed in collaboration with children with autism and their caregivers, to provide an intervention for a subgroup of autism that has been historically underserved. As autism is a heterogeneous condition, it is unlikely that one style of intervention will address all aspects of its symptomatology; the motor skills approach of Point OutWords can complement other therapies that address core autistic symptoms of social cognition and communication more directly. The current feasibility trial can inform the selection of outcome measures and design for future full-scale randomised controlled trials of Point OutWords and of other early interventions in autism.
TRIAL REGISTRATION


ISRCTN, ISRCTN12808402. Prospectively registered on 12 March 2019.",2020,"Children in the control group will have equal caregiver-led contact time with the iPad using a selection of control apps (e.g. sensory apps, drawing apps).","['46 non-verbal or minimally verbal children with autism and their families, approximately 23 per arm', 'children with autism and their caregivers', 'non-verbal or minimally verbal children with autism', 'autism', 'non-verbal children with autism']","['iPad-assisted intervention', 'motor skills intervention']","['Communication, motor, and daily living skills']","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1704764', 'cui_str': 'Per'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0932069,"Children in the control group will have equal caregiver-led contact time with the iPad using a selection of control apps (e.g. sensory apps, drawing apps).","[{'ForeName': 'Ailbhe', 'Initials': 'A', 'LastName': 'McKinney', 'Affiliation': 'Division of Psychology, Nottingham Trent University, Nottingham, UK. ailbhe.mc-kinney@ucdconnect.ie.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Hotson', 'Affiliation': 'Division of Psychology, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Rybicki', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma J L', 'Initials': 'EJL', 'LastName': 'Weisblatt', 'Affiliation': 'Department of Psychology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Días', 'Affiliation': 'Peterborough Integrated Neurodevelopmental Service, Cambridgeshire and Peterborough NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sofía S', 'Initials': 'SS', 'LastName': 'Villar', 'Affiliation': 'MRC Biostatistics Unit, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Institute for Health Research, University of Bedfordshire, Bedford, UK.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Belmonte', 'Affiliation': 'Division of Psychology, Nottingham Trent University, Nottingham, UK.'}]",Trials,['10.1186/s13063-019-3931-1']
3620,31345107,Comparative effects of enalapril versus perindopril on serum levels of leptin and adiponectin in hypertensive patients.,"Introduction:  Abnormal adipokine levels affect blood pressure (BP) regulation. Hypo-adiponectinaemia and hyperleptinaemia were reported in hypertension, little is known about how antihypertensive therapy affects these alterations. This study aimed to evaluate the effects of perindopril versus enalapril on plasma adiponectin, tumour necrosis alpha (TNF-α) and leptin levels in hypertensive individuals. Methods:  In the present study, we analysed the samples obtained from 93 treatment-naıve, adult hypertensive patients, randomised to treatement with enalapril (10 mg/d,  n  = 31), perindopril (5 mg/d,  n  = 31), or maintained on life style modification ( n  = 31). Plasma levels of leptin, adiponectin, TNF-α and lipid profile were determined at baseline, and after 3 months. Results:  Compared to subjects maintained on lifestyle modification ( n  = 31), enalapril or perindopril treatment was associated with a significant decrease in BP. Administration of perindopril or enalapril resulted in an increase in plasma adiponectin and a reduction in plasma leptin. No significant changes in lipid profile were observed after treatment. Conclusions:  Our results indicate that perindopril is superior to enalapril when it comes to its effect on the human adipose-tissue-derived hormones. This suggests that angiotensin-converting enzyme inhibitors improves the adipokine profile, possibly allowing beneficial effects to hypertensive individuals.",2020,Administration of perindopril or enalapril resulted in an increase in plasma adiponectin and a reduction in plasma leptin.,"['hypertensive patients', 'hypertensive individuals', '93 treatment-naıve, adult hypertensive patients']","['angiotensin-converting enzyme inhibitors', 'perindopril', 'enalapril or perindopril', 'enalapril', 'perindopril versus enalapril', 'perindopril or enalapril']","['Plasma levels of leptin, adiponectin, TNF-α and lipid profile', 'plasma adiponectin, tumour necrosis alpha (TNF-α) and leptin levels', 'serum levels of leptin and adiponectin', 'plasma leptin', 'plasma adiponectin', 'lipid profile', 'blood pressure (BP) regulation', 'BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis (morphologic abnormality)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",93.0,0.0260195,Administration of perindopril or enalapril resulted in an increase in plasma adiponectin and a reduction in plasma leptin.,"[{'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Damanhour University, Damanhour, Egypt.'}, {'ForeName': 'Ibtsam', 'Initials': 'I', 'LastName': 'Khairat', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Lamiaa', 'Initials': 'L', 'LastName': 'Khedr', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Alaa El-Din', 'Initials': 'AE', 'LastName': 'El-Sisi', 'Affiliation': 'Pharmacology & Toxicology Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.'}]",Acta cardiologica,['10.1080/00015385.2019.1636533']
3621,32000822,"Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.","BACKGROUND


Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled, multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D.
METHODS/DESIGN


We will recruit 430 participants with IBS-D from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers and gut-related measurements from magnetic resonance imaging data.
DISCUSSION


This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.
TRIAL REGISTRATION


ISRCTN17149988. Prospectively registered on 14 November 2017.",2020,"Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use.","['Irritable bowel syndrome (IBS) with diarrhoea (IBS-D', 'Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period', '430 participants with IBS-D from approximately 30 primary and secondary care sites in England', 'Prospectively registered on 14 November 2017', 'irritable bowel syndrome with diarrhoea (IBS-D) in adults']","['placebo', 'blinded treatment (Enterosgel® or placebo', 'Enterosgel®']","['percentage of participants defined as responders for abdominal pain and stool consistency', 'efficacy, tolerability and safety', 'stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use', 'efficacy and safety']","[{'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea (disorder)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0527417', 'cui_str': 'Enterogel'}]","[{'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",430.0,0.408287,"Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use.","[{'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kemppinen', 'Affiliation': 'Clever Cookie Ltd, Hove, UK. anu@clevercookie.net.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Howell', 'Affiliation': 'Enteromed Ltd, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Knowles', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Pandya', 'Affiliation': 'The Village Practice, Thornton-Cleveleys, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whorwell', 'Affiliation': 'Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Markaryan', 'Affiliation': 'Enteromed Ltd, London, UK.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yiannakou', 'Affiliation': 'County Durham and Darlington NHS Foundation Trust, University Hospital of North Durham, Durham, UK.'}]",Trials,['10.1186/s13063-020-4069-x']
3622,31992344,"Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol.","INTRODUCTION


Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.
METHODS


This is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.
DISCUSSION


The outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018.
DISCLAIMER


The views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication.
ROLES AND RESPONSIBILITIES


AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.",2020,"Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs.","['individuals with CNLBP who have not had surgery', 'patients with CNLBP who have not had surgery', '96 patients with CNLBP who have not had spinal surgery', 'patients with failed back surgery syndrome (FBSS', 'chronic neuropathic low back pain (MODULATE-LBP']","['10\u2009khz high-frequency spinal cord stimulation', 'kHz SCS plus usual care (intervention group) or to sham 10\u2009kHz SCS plus usual care (control group) after receiving the full implant', 'kHz spinal cord stimulation (SCS', '10\u2009kHz SCS']","['pain and improves health-related quality of life', 'Oswestry Disability Index, complications, EQ-5D-5\u2009L, and health and social care costs', '7-day daily pain diary', 'Incremental cost per quality-adjusted life year (QALY']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}]","[{'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0451366', 'cui_str': 'Pain diary (assessment scale)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",96.0,0.486461,"Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs.","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Al-Kaisy', 'Affiliation': ""Pain Management & Neuromodulation Centre, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH, London, UK. alkaisy@aol.com.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Royds', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Palmisani', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wesley', 'Affiliation': 'Guys & St. Thomas NHS Foundation Trust, London, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health and Well Being, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Wessex Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, Health Services Research, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Fairbank', 'Affiliation': 'University of Oxford, Oxford, UK.'}]",Trials,['10.1186/s13063-019-3831-4']
3623,31990730,Effects of Preoperative Gum Chewing on Sore Throat After General Anesthesia With a Supraglottic Airway Device: A Randomized Controlled Trial.,"BACKGROUND


Postoperative sore throat (POST) is not uncommon after general anesthesia with a supraglottic airway (SGA) device. Although it was reported that some pharmacological and nonpharmacological measures can reduce POST, because of limitations and variable success rates, we need to find a simpler and more effective way to alleviate POST.
METHODS


This prospective, observer-blinded, randomized controlled study enrolled 140 patients who required general anesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA) for <60 minutes. They were randomly divided into the gum (group G, n = 70) and control (group C, n = 70) groups. Before the induction of general anesthesia for 5-10 minutes, the patients in group G chewed gum for 2 minutes. Group C was asked to swallow twice without any additional treatment. A standard anesthesia protocol was followed. The incidence and severity of sore throat were assessed up to 24 hours postoperatively. The primary outcome was the incidence of POST numerical rating scale (NRS) scores >3 within 24 hours after surgery, and the secondary outcomes included the POST (NRS) scores 2, 6, and 24 hours after the surgery.
RESULTS


The incidence of moderate/severe POST (NRS >3) within 24 hours after surgery was significantly lower in group G (10.1%, 7/69) than in group C (40.6%, 28/69) (odds ratio 0.386, 95% confidence interval [CI], 0.153-0.976; P = .044). The median (interquartile range [range]) scores at 2, 6, and 24 hours after anesthesia in group G were lower than those in the control group at the same times (2 hours: 0 [0-3 {0-4}] vs 3 [0-3 {0-6}], P = .048; 6 hours: 0 [0-3 {0-6}] vs 2 [0-4 {0-6}], P = .048; 24 hours: 0 [0-1 {0-7}] vs 0 [0-2 {0-6}]; P = .011). There were 14 patients (20.3%, 14/69) in group G who had blood stains on the SGA device, which was significantly lower than the number in group C (37.7%, 26/69) (P = .024). In patients with bloody SGA devices, the incidence of POST scores >3 was significantly lower in group G (14.3%, 2/14) than in group C (73.1%, 19/26) (P < .001), while there was no significant difference between the 2 groups in the incidence of POST score >3 in patients without bloody SGA devices (group G: 9.1%, 5/55; group C: 20.9%, 9/43; P = .145).
CONCLUSIONS


Chewing gum before surgery can effectively reduce POST with a SGA device for hysteroscopic surgery, especially in patients with pharyngeal mucosal injury.",2020,"The incidence of moderate/severe POST (NRS >3) within 24 hours after surgery was significantly lower in group G (10.1%, 7/69) than in group C (40.6%, 28/69) (odds ratio 0.386, 95% confidence interval [CI], 0.153-0.976; P = .044).","['140 patients who required general anesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA) for <60 minutes', 'patients with pharyngeal mucosal injury']",['Preoperative Gum Chewing'],"['incidence of POST scores', 'incidence of POST score', 'incidence and severity of sore throat', 'blood stains', 'incidence of POST numerical rating scale (NRS) scores', 'Sore Throat']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0181663', 'cui_str': 'Liner (physical object)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0005835', 'cui_str': 'Blood Stains'}, {'cui': 'C0222045'}]",140.0,0.0714556,"The incidence of moderate/severe POST (NRS >3) within 24 hours after surgery was significantly lower in group G (10.1%, 7/69) than in group C (40.6%, 28/69) (odds ratio 0.386, 95% confidence interval [CI], 0.153-0.976; P = .044).","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'From the Department of Anaesthesia, Obstetrics & Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Haiyang', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004664']
3624,32000241,The Effectiveness of Workshop and Multimedia Training Methods on the Nurses' Decision-Making Skills Regarding Weaning From Mechanical Ventilation.,"BACKGROUND


Nurses can safely and effectively wean patients from mechanical ventilation (MV) by the use of proper instruments and planning.
OBJECTIVE


The aim of this study was to compare the effectiveness of 2 training methods on the decision-making skill of intensive critical care (ICU) nurses with regard to weaning from MV.
METHODS


In this quasi-experimental study, 80 nurses working in ICUs participated in 1 of 2 educational groups in 2016. The interventions were workshop and multimedia training for decision-making skill regarding weaning from MV. The data were gathered from a questionnaire based on the Burns Weaning Assessment Program tool before and 1 month after the intervention. Data were analyzed by independent t test, the χ test, and the Fisher exact test using the software SPSS v. 17.
RESULTS


The decision-making skill with regard to awareness of weaning factors (physiological and respiratory) increased in both groups after the intervention (P ≤ .001), but the difference between the 2 groups was not statistically meaningful. Considering the mean scores before and after the intervention, the general skill of decision-making regarding weaning from MV was higher in the multimedia training group compared with the workshop training group (P ≤ .001).
CONCLUSION


The multimedia training method, which has been more successful, is recommended owing to its characteristics of virtual education, such as accessibility, flexibility, learner centeredness, and expansibility, as well as nurses' lack of time.",2020,"The decision-making skill with regard to awareness of weaning factors (physiological and respiratory) increased in both groups after the intervention (P ≤ .001), but the difference between the 2 groups was not statistically meaningful.",['80 nurses working in ICUs participated in 1 of 2 educational groups in 2016'],"['Workshop and Multimedia Training Methods', 'workshop and multimedia training for decision-making skill regarding weaning from MV']","['awareness of weaning factors (physiological and respiratory', 'general skill of decision-making regarding weaning from MV']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}]",80.0,0.0355136,"The decision-making skill with regard to awareness of weaning factors (physiological and respiratory) increased in both groups after the intervention (P ≤ .001), but the difference between the 2 groups was not statistically meaningful.","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Dehghan-Nayeri', 'Affiliation': 'Nahid Dehghan-Nayeri, PhD, is a professor at Nursing and Midwifery Care Research Center and School of Nursing and Midwifery, Tehran University of Medical Sciences, Iran. Parvaneh Vasli, PhD, is an assistant professor at School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Khatereh Seylani, PhD, is an assistant professor in the critical care nursing department at School of Nursing and Midwifery, Tehran University of Medical Sciences, Iran. Samira Fallahi, MSN, is a graduate from the School of Nursing and Midwifery, Tehran University of Medical Science, Iran. Flora Rahimaghaee, PhD, is an associate professor at the Nursing Department, Islamic Azad University, Tonekabon, Iran. Anoushirvan Kazemnejad, PhD, is a professor at the Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Vasli', 'Affiliation': ''}, {'ForeName': 'Khatereh', 'Initials': 'K', 'LastName': 'Seylani', 'Affiliation': ''}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Fallahi', 'Affiliation': ''}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Rahimaghaee', 'Affiliation': ''}, {'ForeName': 'Anoushirvan', 'Initials': 'A', 'LastName': 'Kazemnejad', 'Affiliation': ''}]",Dimensions of critical care nursing : DCCN,['10.1097/DCC.0000000000000404']
3625,31990800,When to Remove the Indwelling Catheter After Minimally Invasive Sacrocolpopexy? CARESS (CAtheter REmoval after Sacrocolpopexy Surgery).,"OBJECTIVE


The aim of the study was to determine the best practice guidelines regarding the use of indwelling catheters after minimally invasive sacrocolpopexy.
METHODS


Multicenter (3 sites) randomized control trial comparing the standard overnight indwelling urethral catheterization (group 2) with removal of catheter immediately after surgery (group 1). Our primary outcome is the need for recatheterization. Secondary outcomes include the number of patients discharged with a catheter, length of hospital stay, number of urinary tract infections, patient satisfaction/pain scores, and whether patients would use the same treatment again.
RESULTS


There were 32 patients (43.8%) in group 1 and 41 patients (56.2%) in group 2. On average, patients in group 1 required straight catheterization 0.8 (SD = 0.9) times versus 0.6 (SD = 0.9) times for group 2 (P = 0.239). The number of days with a catheter between the 2 groups was not statistically significant. There was no statistical significance between group 1 and group 2 in terms of operative time, times to leave the operating room, and hospital. Zero patients in group 1 and 2 patients in group 2 had a urinary tract infection. After dividing the groups based on whether or not they underwent a transvaginal tape procedure, the final results were similar.
CONCLUSIONS


We did not observe a difference in the risk of recatheterization or discharge home with a urinary catheter between the 2 groups. Addition of transvaginal tape to sacrocolpopexy did not show a difference in the risk of recatheterization. One reason for the lack of difference between the 2 groups could be due to a lack of power in our study.",2020,"There was no statistical significance between group 1 and group 2 in terms of operative time, times to leave the operating room, and hospital.",[],"['transvaginal tape to sacrocolpopexy', 'standard overnight indwelling urethral catheterization (group 2) with removal of catheter immediately after surgery', 'Indwelling Catheter']","['risk of recatheterization', 'operative time, times to leave the operating room, and hospital', 'risk of recatheterization or discharge home', 'number of patients discharged with a catheter, length of hospital stay, number of urinary tract infections, patient satisfaction/pain scores, and whether patients would use the same treatment again', 'straight catheterization', 'need for recatheterization', 'number of days with a catheter', 'urinary tract infection']",[],"[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C1455681', 'cui_str': 'Insertion of urethral catheter (procedure)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0542711,"There was no statistical significance between group 1 and group 2 in terms of operative time, times to leave the operating room, and hospital.","[{'ForeName': 'Muhammad Faisal', 'Initials': 'MF', 'LastName': 'Aslam', 'Affiliation': 'From the Department of Obstetrics and Gynecology at St. John Hospital and Medical Center, Detroit, MI.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Bazzi', 'Affiliation': 'From the Department of Obstetrics and Gynecology at St. John Hospital and Medical Center, Detroit, MI.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Hagglund', 'Affiliation': 'From the Department of Obstetrics and Gynecology at St. John Hospital and Medical Center, Detroit, MI.'}, {'ForeName': 'Blake C', 'Initials': 'BC', 'LastName': 'Osmundsen', 'Affiliation': 'Division of Organology and Reconstructive Pelvic Surgery, Legacy Health, Portland, OR.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000826']
3626,30227980,Original Research: Aerosolized Lidocaine: Effective for Safer Arousal After Suspension Laryngoscopy.,"AIM


To examine the systemic and local effects of the lidocaine on the larynx and trachea which is applied after the end of the surgery and through various application methods.
STUDY DESIGN


Randomized controlled prospective study.
METHOD


The study is composed of patients who underwent suspension laryngoscopy (SL) for benign laryngeal diseases (cysts, polyp, granuloma, etc) and American Society of Anesthesiologists (ASA) I, between January 2017 and January 2018. The patients were randomly divided into 3 groups. In the first group nothing is applied at the end of the surgery and called as control group, second group received 7 pufs of aerosolized 10% lidocaine solution (70 mg) over larynx and trachea and third group received cotton swaps that impregnated in 1 ml of 20 mg lidocaine solution over surgical area for 1 minutes. Operation and arousal times, heart rate and mean arterial blood pressure levels were noted and compared. Also laryngospasm, cough, and agitation scores were obtained during arousal.
RESULTS


64 patients were included in the study. Laryngospasm was not observed in any of the patients. In group 2 (aerosolized lidocaine group), patients' blood pressure remained similar while increased in other groups (P < 0.05). Agitation scores were significantly lower in group 2 compared to the other groups (P = 0.012). Cough reflex is observed less in group 2 but result was not statistically significant (P = 0.13) CONCLUSION: The usage of aerosolized lidocaine after suspension laryngoscopy is very effective in blocking the stimulation of superior laryngeal nerve and sympathetic nerves which were responsible for the pressor reflexes. The inhibition of these reflexes before or during arousal could secure a safer arousal.",2020,Agitation scores were significantly lower in group 2 compared to the other groups (P = 0.012).,"['patients who underwent', 'benign laryngeal diseases (cysts, polyp, granuloma, etc) and American Society of Anesthesiologists (ASA', '64 patients were included in the study']","['lidocaine', 'suspension laryngoscopy (SL', 'Aerosolized Lidocaine', 'aerosolized lidocaine', 'aerosolized 10% lidocaine solution (70 mg) over larynx and trachea and third group received cotton swaps that impregnated in 1 ml of 20 mg lidocaine solution']","['blood pressure', 'Operation and arousal times, heart rate and mean arterial blood pressure levels', 'Agitation scores', 'Laryngospasm', 'Safer Arousal', 'Cough reflex', 'Also laryngospasm, cough, and agitation scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0023051', 'cui_str': 'Larynx Diseases'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0018188', 'cui_str': 'Granuloma'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0040578', 'cui_str': 'Trachea'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0232051', 'cui_str': 'Cough reflex (observable entity)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",64.0,0.0195325,Agitation scores were significantly lower in group 2 compared to the other groups (P = 0.012).,"[{'ForeName': 'Ceki', 'Initials': 'C', 'LastName': 'Paltura', 'Affiliation': 'Gaziosmanpaşa Taksim Education and Research Hospital Otolaryngology Department, İstanbul, Turkey. Electronic address: palturaceki@gmail.com.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Güvenç', 'Affiliation': 'Gaziosmanpaşa Taksim Education and Research Hospital Otolaryngology Department, İstanbul, Turkey.'}, {'ForeName': 'Ömer Necati', 'Initials': 'ÖN', 'LastName': 'Develioğlu', 'Affiliation': 'Gaziosmanpaşa Taksim Education and Research Hospital Otolaryngology Department, İstanbul, Turkey.'}, {'ForeName': 'Kürşat', 'Initials': 'K', 'LastName': 'Yelken', 'Affiliation': 'Uskudar University, Faculty of Health Sciences, Odiology Department, Üsküdar/İstanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Külekçi', 'Affiliation': 'Gaziosmanpaşa Taksim Education and Research Hospital Otolaryngology Department, İstanbul, Turkey.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.08.012']
3627,31833570,Treatment of dehiscence-type defects with collagen matrix and/or enamel matrix derivative: Histomorphometric study in minipigs.,"BACKGROUND


This study aimed to evaluate, histomorphometrically, the use of collagen matrix (CM) and/or enamel matrix derivative (EMD) for the treatment of dehiscence-type recession defects in minipigs.
METHODS


Eight healthy, male, young BR-1 minipigs, with no periodontal disease were treated. Bilateral dehiscence-type defects were surgically created on the buccal of the mandibular premolars (PI and PII). After 30 days, the defects were randomly assigned to four groups: coronally advanced flap (CAF); CAF + CM; CAF + EMD; and CAF + CM + EMD (split-mouth design). The evaluated parameters (mm): total defect length; new cementum (NC); new bone (NB); gingival margin position; total epithelium length; epithelium on the root; connective tissue adaptation; and soft tissue thickness (STT).
RESULTS


The EMD-treated groups showed a superior length of NC [4.13 ± 1.22 (CAF + EMD); 3.95 ± 1.11 (CAF + CM + EMD); 2.94 ± 0.77 (CAF + CM); 2.72 ± 0.81 (CAF), P = 0.02] and NB [3.21 ± 0.68 (CAF + CM + EMD); 3.01 ± 0.56 (CAF + EMD); 2.15 ± 0.47 (CAF + CM); 2.29 ± 0.82 (CAF), P = 0.005]. The CAF and CAF + CM groups showed a superior epithelial length when compared to EMD-treated groups after 3 months. A superior STT was observed for CAF + CM + EMD group (1.5 ± 0.33) when compared with the other groups [1.09 ± 0.26 (CAF + EMD); 1.04 ± 0.34 (CAF + CM); and 1.14 ± 0.29 (CAF), P = 0.03].
CONCLUSION(S)


The results of the present study indicate that EMD application, irrespective of the combination with CM, may improve the periodontal regeneration of dehiscence-type defects in this animal model.",2020,The CAF and CAF + CM groups showed a superior epithelial length when compared to EMD-treated groups after 3 months.,"['dehiscence-type recession defects in minipigs', 'Eight healthy, male, young BR-1 minipigs, with no periodontal disease were treated']","['coronally advanced flap (CAF); CAF + CM; CAF + EMD; and CAF + CM + EMD', 'CAF + CM + EMD', 'collagen matrix (CM) and/or enamel matrix derivative (EMD']","['Bilateral dehiscence-type defects', 'superior epithelial length', 'periodontal regeneration of dehiscence-type defects', 'total defect length; new cementum (NC); new bone (NB); gingival margin position; total epithelium length; epithelium on the root; connective tissue adaptation; and soft tissue thickness (STT']","[{'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0039011', 'cui_str': 'Minipigs'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0011343', 'cui_str': 'Cementum'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}]",8.0,0.0209352,The CAF and CAF + CM groups showed a superior epithelial length when compared to EMD-treated groups after 3 months.,"[{'ForeName': 'Isabela Lima', 'Initials': 'IL', 'LastName': 'França-Grohmann', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'João Paulo Menck', 'Initials': 'JPM', 'LastName': 'Sangiorgio', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Manuela Rocha', 'Initials': 'MR', 'LastName': 'Bueno', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Renato Corrêa Viana', 'Initials': 'RCV', 'LastName': 'Casarin', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Karina Gonzáles', 'Initials': 'KG', 'LastName': 'Silvério Ruiz', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Francisco Humberto', 'Initials': 'FH', 'LastName': 'Nociti', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Márcio Zaffalon', 'Initials': 'MZ', 'LastName': 'Casati', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}, {'ForeName': 'Enilson Antonio', 'Initials': 'EA', 'LastName': 'Sallum', 'Affiliation': 'Division of Periodontics, Piracicaba Dental School/State University of Campinas (UNICAMP), Piracicaba, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0107']
3628,31992445,The effectiveness of graded motor imagery for reducing phantom limb pain in amputees: a randomised controlled trial.,"OBJECTIVE


To investigate whether graded motor imagery (GMI) is effective for reducing phantom limb pain (PLP) in people who have undergone limb amputations.
DESIGN


A single-blinded randomised, controlled trial.
SETTING


Physiotherapy out-patient departments in three secondary level hospitals in Cape Town, South Africa.
PARTICIPANTS


Twenty-one adults (≥18 years) who had undergone unilateral upper or lower limb amputations and had self-reported PLP persisting beyond three months.
INTERVENTIONS


A 6-week GMI programme was compared to routine physiotherapy. The study outcomes were evaluated at baseline, 6 weeks, 3 months and 6 months.
OUTCOME MEASURES


The pain severity scale of the Brief Pain Inventory (BPI) was used to assess the primary outcome - PLP. The pain interference scale of the BPI and the EuroQol EQ-5D-5L were used to assess the secondary outcomes - pain interference with function and health-related quality of life (HRQoL) respectively.
RESULTS


The participants in the experimental group had significantly greater improvements in pain than the control group at 6 weeks and 6 months. Further, the participants in the experimental group had significantly greater improvements than the control group in pain interference at all follow-up points. There was no between-group difference in HRQoL.
CONCLUSION


The results of the current study suggest that GMI is better than routine physiotherapy for reducing PLP. Based on the significant reduction in PLP and pain interference within the participants who received GMI, and the ease of application, GMI may be a viable treatment for treating PLP in people who have undergone limb amputations.
CLINICAL TRIAL REGISTRATION NUMBER


(PACTR201701001979279).",2020,"Further, the participants in the experimental group had significantly greater improvements than the control group in pain interference at all follow-up points.","['people who have undergone limb amputations', 'Twenty-one adults (≥18 years) who had undergone unilateral upper or lower limb amputations and had self-reported PLP persisting beyond three months', 'amputees', 'Physiotherapy out-patient departments in three secondary level hospitals in Cape Town, South Africa']","['GMI programme was compared to routine physiotherapy', 'graded motor imagery', 'graded motor imagery (GMI']","['PLP and pain interference', 'pain severity scale of the Brief Pain Inventory (BPI', 'phantom limb pain (PLP', 'pain', 'pain interference scale', 'pain interference']","[{'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0337308', 'cui_str': 'Amputation of lower limb (procedure)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0002695', 'cui_str': 'Amputees'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0031315', 'cui_str': 'Phantom Sensation'}]",21.0,0.208983,"Further, the participants in the experimental group had significantly greater improvements than the control group in pain interference at all follow-up points.","[{'ForeName': 'Katleho', 'Initials': 'K', 'LastName': 'Limakatso', 'Affiliation': 'Pain Management Unit, Department of Anaesthesia and Perioperative Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Madden', 'Affiliation': 'Pain Management Unit, Department of Anaesthesia and Perioperative Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Department of Psychiatry and Mental Health, Faculty of Health Sciences, University of Cape Town, Groote Schuur Hospital, Cape Town, South Africa.'}, {'ForeName': 'Shamila', 'Initials': 'S', 'LastName': 'Manie', 'Affiliation': 'Division of Physiotherapy, Department of Health and Rehabilitation Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Parker', 'Affiliation': 'Pain Management Unit, Department of Anaesthesia and Perioperative Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Division of Physiotherapy, Department of Health and Rehabilitation Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa. Electronic address: romy.parker@uct.ac.za.'}]",Physiotherapy,['10.1016/j.physio.2019.06.009']
3629,31996978,Improving the dietary quality of food parcels leads to improved dietary intake in Dutch food bank recipients-effects of a randomized controlled trial.,"PURPOSE


Since food banks have a strong influence on recipients' diets, and seem to have difficulties in supporting healthy diets, improving the dietary quality of food parcels is important. The aim of our study was to assess whether improving the dietary quality of food parcels, using different strategies, can positively impact the actual dietary intake of Dutch food bank recipients.
METHODS


This randomized cross-over controlled trial (Trial ID: ISRCTN40554133) with four intervention conditions [(1) Control (standard food parcel), (2) snacks -  (standard food parcel with replacement of unhealthy snacks by staple foods), (3) FV +  (standard food parcel plus the recommended daily amount of fruit and vegetables), (4) snacks -  + FV +  (standard food parcel with replacement of unhealthy snacks by staple foods plus the recommended daily amount of fruit and vegetables)] included 163 food bank recipients, from three food banks. At baseline, participants filled in a questionnaire. Dietary intake data were collected through 24-h recalls after both intervention conditions at 4 and 8 weeks follow-up. Primary outcome was daily fruit and vegetable intake, secondary outcomes were daily dietary intakes of food groups and nutrients.
RESULTS


Multi-level linear regression analysis, using a two-level model, showed a higher mean daily fruit intake in participants in the FV +  condition than in participants in the Control condition (delta (δ): 74 [40.3;107.6] g). Both mean daily fruit and vegetable intake were higher in participants in the Snacks -  + FV +  condition than in participants in the Control condition (fruit δ: 81.3 [56.5;106.2] g; vegetables δ: 46.2 [17.5;74.9] g), as well as in the Snacks -  condition (fruit δ: 70.0 [38.8;101.1] g; vegetables δ: 62.2 [26.2; 98.2] g).
CONCLUSIONS


This study shows that improving the dietary quality of food parcels can positively impact the dietary intake of Dutch food bank recipients. With this information we can further develop effective strategies that can be easily applied by food banks, to improve dietary intake of food bank recipients.",2020,Both mean daily fruit and vegetable intake were higher in participants in the Snacks -  + FV +  condition than in participants in the Control condition (fruit δ: 81.3 [56.5;106.2],['Dutch food bank recipients'],"['four intervention conditions [(1) Control (standard food parcel), (2) snacks -  (standard food parcel with replacement of unhealthy snacks by staple foods), (3) FV +  (standard food parcel plus the recommended daily amount of fruit and vegetables), (4) snacks - \u2009+\u2009FV +  (standard food parcel with replacement of unhealthy snacks by staple foods plus the recommended daily amount of fruit and vegetables']","['mean daily fruit and vegetable intake', 'mean daily fruit intake', 'daily fruit and vegetable intake, secondary outcomes were daily dietary intakes of food groups and nutrients']","[{'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0442598', 'cui_str': 'Bank (environment)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",,0.0448879,Both mean daily fruit and vegetable intake were higher in participants in the Snacks -  + FV +  condition than in participants in the Control condition (fruit δ: 81.3 [56.5;106.2],"[{'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Neter', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. judith.neter@vu.nl.'}, {'ForeName': 'S Coosje', 'Initials': 'SC', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VU University Medical Center, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}]",European journal of nutrition,['10.1007/s00394-020-02182-8']
3630,31818787,Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma.,"BACKGROUND


This analysis investigates the efficacy of vortioxetine in adults with major depressive disorder (MDD) who report childhood or recent trauma.
METHODS


Patient-level data were analyzed from 4 double-blind, randomized, placebo-controlled short-term studies investigating the efficacy of vortioxetine (5-20 mg/day) versus placebo in patients (18-75 years old) with DSM-IV-TR-defined MDD. Changes from baseline to week 8 on the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression - Improvement (CGI-I), and Sheehan Disability Scale (SDS) were examined at the individual study level and as in meta-analysis. A long-term relapse prevention study of 5 and 10 mg of vortioxetine was also analyzed. Traumatic events history was recorded at baseline.
RESULTS


Sixty-one percent of subjects (1113/1811) reported trauma history in the short-term studies. A significant effect vs. placebo was observed for vortioxetine on MADRS (10 mg, -2.2, P = .025; 20 mg, -4.4, P < .001), HAM-A (20 mg, -1.60, P = .012), CGI-I (5 mg, -0.3, P = .028; 10 mg, -0.3, P = .013; 20 mg, -0.50, P = .009), and SDS (20 mg, -2.3, P = .007) in patients with any trauma (childhood and/or recent). In the relapse prevention study, 51% (198/392) of subjects reported a history of trauma. Subjects with any trauma (childhood and/or recent) randomized to placebo were significantly more likely to relapse than subjects treated with vortioxetine (hazard ratio 2.8, P = .0019).
LIMITATIONS


An exploratory analysis.
DISCUSSION


Vortioxetine showed significant short- and long-term efficacy on depressive and anxiety symptoms and overall functioning in this large subpopulation of MDD patients with a history of trauma. A significantly lower risk of relapse was also observed with vortioxetine.",2020,"A significant effect vs. placebo was observed for vortioxetine on MADRS (10 mg, -2.2, P = .025; 20 mg, -4.4, P < .001), HAM-A (20 mg, -1.60, P = .012), CGI-I (5 mg, -0.3, P = .028; 10 mg, -0.3, P = .013; 20 mg, -0.50, P = .009), and SDS (20 mg, -2.3, P = .007) in patients with any trauma (childhood and/or recent).","['MDD patients with a history of trauma', 'patients (18-75 years old) with DSM-IV-TR-defined MDD', 'adults with major depressive disorder (MDD) who report childhood or recent trauma', 'patients with major depressive disorder reporting childhood or recent trauma', 'Subjects with any trauma (childhood and/or recent) randomized to', 'Patient-level data']","['vortioxetine', 'placebo', 'Vortioxetine']","['depressive and anxiety symptoms and overall functioning', 'history of trauma', 'MADRS', 'risk of relapse', 'Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression - Improvement (CGI-I), and Sheehan Disability Scale (SDS', 'trauma history']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0332665', 'cui_str': 'Recent injury (morphologic abnormality)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]",,0.113612,"A significant effect vs. placebo was observed for vortioxetine on MADRS (10 mg, -2.2, P = .025; 20 mg, -4.4, P < .001), HAM-A (20 mg, -1.60, P = .012), CGI-I (5 mg, -0.3, P = .028; 10 mg, -0.3, P = .013; 20 mg, -0.50, P = .009), and SDS (20 mg, -2.3, P = .007) in patients with any trauma (childhood and/or recent).","[{'ForeName': 'Michael Cronquist', 'Initials': 'MC', 'LastName': 'Christensen', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark. Electronic address: MCRC@lundbeck.com.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Florea', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Loft', 'Affiliation': 'H. Lundbeck A/S, Valby, Denmark.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, ON, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.074']
3631,31992331,Clinical evaluation of ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing in the treatment of periodontitis: study protocol for a randomized controlled trial.,"BACKGROUND


Periodontal diseases are regarded as the most common diseases of mankind. The prevalence rate of periodontal disease assumes a clear growth tendency, increasing by 57.3% from 1990 to 2010. Thereby, effective periodontal therapy is still a long-term task and a difficult problem. The goals of periodontal therapy are to eliminate the infectious and inflammatory processes of periodontal diseases. Root planing, in order to eliminate the ""infected cementum,"" has been an important step in the treatment of periodontitis since the 1970s. However, along with the understanding of the effects of endotoxin on the root surface, the necessity of manual root planing has been gradually queried. Ultrasonic instruments, which are more recent innovations, would not remove the cementum excessively, and are also more time-saving and labor-saving compared to using hand instruments. Hence, an increasing number of dentists prefer to do scaling with ultrasonic instruments only. However, the necessity of root planing remains emphasized in the international mainstream views of periodontal mechanical treatment. Therefore, this study is devoted to compare the clinical effect of ultrasonic subgingival debridement and ultrasonic subgingival scaling combined with manual root planing, which takes the implementation of root planing as the only variable and is more in line with the current clinical situation, thus hoping to provide some valuable reference to dentists.
METHODS/DESIGN


Forty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology (Beijing, China). By means of randomization tables, one quadrant of the upper and lower teeth is the test group and the other is the control group. Test group: ultrasonic subgingival scaling combined with manual root planing.
CONTROL GROUP


ultrasonic subgingival debridement. In a 24-week follow-up period, plaque index, probing depth, clinical attachment loss, bleeding index, furcation involvement, mobility, and patient-reported outcome (Visual Analog Scale for pain and sensitivity) will be observed and documented.
DISCUSSION


This study evaluates the effectiveness of ultrasonic subgingival scaling combined with manual root planing and ultrasonic subgingival debridement alone in the nonsurgical treatment of periodontitis with a split-mouth design after 1, 3 and 6 months. The result of the trial should potentially contribute to an advanced treatment strategy for periodontitis with an ideal clinical outcome.
TRIAL REGISTRATION


International Clinical Trials Registry Platform (ICTRP), ID: ChiCTR1800017122. Registered on 12 July 2018.",2020,"In a 24-week follow-up period, plaque index, probing depth, clinical attachment loss, bleeding index, furcation involvement, mobility, and patient-reported outcome (Visual Analog Scale for pain and sensitivity) will be observed and documented.
","['periodontitis', 'periodontitis with a split-mouth design after 1, 3 and 6\u2009months', 'Forty adult patients who fit the inclusion criteria are being recruited from the Peking University Hospital of Stomatology (Beijing, China']","['ultrasonic subgingival scaling combined with manual root planing', 'ultrasonic subgingival debridement and ultrasonic subgingival scaling combined with manual root planing', 'ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing', 'ultrasonic subgingival scaling combined with manual root planing and ultrasonic subgingival debridement alone', 'endotoxin']","['plaque index, probing depth, clinical attachment loss, bleeding index, furcation involvement, mobility, and patient-reported outcome (Visual Analog Scale for pain and sensitivity']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0029167', 'cui_str': 'Stomatology'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0086958', 'cui_str': 'Scaling, Subgingival'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",40.0,0.030895,"In a 24-week follow-up period, plaque index, probing depth, clinical attachment loss, bleeding index, furcation involvement, mobility, and patient-reported outcome (Visual Analog Scale for pain and sensitivity) will be observed and documented.
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology, 22 Zhongguancun South Avenue, Haidian District, Beijing, 100081, People's Republic of China.""}, {'ForeName': 'Yalin', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Department of General Dentistry, First Clinical Division, Peking University School and Hospital of Stomatology and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology, Beijing, China.'}, {'ForeName': ""Xian'e"", 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology, 22 Zhongguancun South Avenue, Haidian District, Beijing, 100081, People's Republic of China.""}, {'ForeName': 'Jianxia', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology, 22 Zhongguancun South Avenue, Haidian District, Beijing, 100081, People's Republic of China. jxhou@163.com.""}]",Trials,['10.1186/s13063-019-4031-y']
3632,31992356,Does a mindfulness-augmented version of the German Strengthening Families Program reduce substance use in adolescents? Study protocol for a randomized controlled trial.,"BACKGROUND


Mindfulness training (MT) for parents of adolescents has been shown to improve mental health and stress-related outcomes in individuals and their families. Studies of MT among young people are mainly delivered in educational or clinical settings, and there is a need for controlled studies on both parent-directed and adolescent-directed approaches. It is unclear whether MT has preventive effects for substance use outcomes. The primary objective of this trial is to evaluate the effectiveness of family-based MT targeting both adolescents and their parents to prevent adolescent substance use and enhance neurobehavioral self-regulation skills that play a major role in addiction development and mental health.
METHODS/DESIGN


The trial design is a superiority, two-arm, randomized controlled trial in which families will participate either in the full curriculum of the evidence-based Strengthening Families Program 10-14 (SFP 10-14, German adaptation) or in a mindfulness-enhanced version of this program (SFP-Mind). Both seven-session interventions are highly structured and will each be delivered over a period of approximately 7 weeks. The experimental intervention SFP-Mind is a modified version of the SFP 10-14 in which some elements were eliminated or changed to enable the inclusion of additional parent-directed and adolescent-directed mindfulness components. The primary outcome is adolescent self-reported alcohol use based on an alcohol initiation index at 18-month follow-up. Dispositional mindfulness, impulsivity, and emotion regulation will be included as secondary outcomes and potential mechanisms of action. The study will recruit and randomize 216 adolescents, aged 10-14 years, and their parents who will be followed up for 18 months.
DISCUSSION


This trial aims to evaluate the effectiveness of SFP-Mind for family-based prevention of substance use and promoting mental health in adolescence.
TRIAL REGISTRATION


German Register of Clinical Studies, DRKS00015678. Registered on 25 February 2019.",2020,"This trial aims to evaluate the effectiveness of SFP-Mind for family-based prevention of substance use and promoting mental health in adolescence.
","['families will participate either in the full curriculum of the evidence-based Strengthening Families Program 10-14', 'parents of adolescents', '216 adolescents, aged 10-14\u2009years, and their parents who will be followed up for 18\u2009months']","['MT', 'SFP-Mind', 'Mindfulness training (MT', 'family-based MT']","['adolescent self-reported alcohol use based on an alcohol initiation index', 'Dispositional mindfulness, impulsivity, and emotion regulation']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0075029', 'cui_str': 'spleen fibrinolytic proteinase (human)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.167512,"This trial aims to evaluate the effectiveness of SFP-Mind for family-based prevention of substance use and promoting mental health in adolescence.
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Arnaud', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. n.arnaud@uke.de.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Baldus', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Léa Josette', 'Initials': 'LJ', 'LastName': 'Laurenz', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Bröning', 'Affiliation': 'Institute of Research and Education GmbH associated with the Medical School Hamburg (MSH), Hamburg, Germany.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Brandt', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Kunze', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Austermann', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zimmermann', 'Affiliation': 'Institute of Research and Education GmbH associated with the Medical School Hamburg (MSH), Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Thomasius', 'Affiliation': 'German Centre for Addiction Research in Childhood and Adolescence, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-4065-1']
3633,31999048,The predictive value of the early maladaptive schemas in social situations in anorexia nervosa.,"BACKGROUND


Patients with anorexia nervosa (AN) show an impairment in the recognition and expression of emotions, as well as an increased sensitivity to being socially excluded, and rigid maladaptive schemas. The Cyberball paradigm is a virtual ball-toss game that can simulate social exclusion and inclusion. Our aim is to evaluate how cognitive schemas can influence the perception and the evaluation of the experiences of social inclusion/exclusion.
METHODS


Thirty-two AN patients and 34 healthy controls completed a psychological evaluation and were randomly assigned to exclusion or overinclusion paradigm of the Cyberball task.
RESULTS


Patients with AN showed a significantly higher level of maladaptive schemas as well as higher sensitivity to being ostracized by peers in comparison with healthy controls. Regression analyses identified specific significant relation between being ostracized and dependence/incompetence, negativity/pessimism, and self-sacrifice.
DISCUSSION


Our findings provide evidence that patients with AN may be ineffective in expressing their mood in exclusive and overinclusive social situations. Specific cognitive/temperamental schemas might play a role in the way people communicate their feelings, and they could be considered targets for psychotherapy interventions to improve social interpretation and emotional recognition/communication.",2020,"RESULTS


Patients with AN showed a significantly higher level of maladaptive schemas as well as higher sensitivity to being ostracized by peers in comparison with healthy controls.","['Patients with anorexia nervosa (AN', 'Thirty-two AN patients and 34 healthy controls completed a psychological evaluation', 'anorexia nervosa']",['exclusion or overinclusion paradigm of the Cyberball task'],"['ostracized and dependence/incompetence, negativity/pessimism, and self-sacrifice', 'level of maladaptive schemas']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0029947', 'cui_str': 'Overinclusion'}]","[{'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0424134', 'cui_str': 'Negative Thinking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0248362,"RESULTS


Patients with AN showed a significantly higher level of maladaptive schemas as well as higher sensitivity to being ostracized by peers in comparison with healthy controls.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Meneguzzo', 'Affiliation': 'Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Collantoni', 'Affiliation': 'Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Bonello', 'Affiliation': 'Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Busetto', 'Affiliation': 'Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tenconi', 'Affiliation': 'Department of Neuroscience, University of Padova, Padova, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Favaro', 'Affiliation': 'Department of Neuroscience, University of Padova, Padova, Italy.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2724']
3634,31959171,Efficacy of urination in alleviating man's urethral pain associated with flexible cystoscopy: a single-center randomized trial.,"BACKGROUND


This study aimed to assess whether urethral pain can be alleviated by urination in male patients undergoing flexible cystoscopy.
METHODS


Ninety-six male outpatients undergoing flexible cystoscopy were randomly divided into two groups. Patients in the test group urinated during flexible cystoscopy, whilst patients in the control group received no instructions to do so. All patients received 10 mL of 2% lidocaine gel prior to assessment. Using 0 (no-pain) to 10 (unbearable severe pain) pain scores (VAS), we assessed patient discomfort prior to anesthesia gel perfusion (baseline), during gel perfusion, during cystoscope insertion through the urethra, and 15 min post-examination analysis. The entire protocol was completed by a single doctor in our Department of Urology.
RESULTS


The groups showed no statistical differences regarding age or examination time. During cystoscope insertion, the test group recorded significantly lower pain scores 2 (IQR 1-3) - compared to the control group 3 (IQR 2-3), (P = 0.001). No significant differences between other evaluation points were observed between groups.
CONCLUSION


Urethral pain can be significantly alleviated by urination in male patients undergoing flexible cystoscopy through the urethra.
TRIAL REGISTRATION


Registry name: Clinical study of urination action to relieve urethral pain associated with flexible cystoscopy. Registration number: ChiCTR-INR-17013294 Date of Registration: 2017-11-08.",2020,"During cystoscope insertion, the test group recorded significantly lower pain scores 2 (IQR 1-3) - compared to the control group 3 (IQR 2-3), (P = 0.001).","['male patients undergoing flexible cystoscopy through the urethra', 'Ninety-six male outpatients undergoing', 'Registry name', 'male patients undergoing flexible cystoscopy', '10 (unbearable severe pain']","['flexible cystoscopy', 'urination', 'lidocaine gel', 'urination action']","['lower pain scores', 'pain scores (VAS']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy (procedure)'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]","[{'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy (procedure)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",96.0,0.10388,"During cystoscope insertion, the test group recorded significantly lower pain scores 2 (IQR 1-3) - compared to the control group 3 (IQR 2-3), (P = 0.001).","[{'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China.'}, {'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China. docxyx@126.com.'}]",BMC urology,['10.1186/s12894-019-0541-x']
3635,31995239,Real-Time Energy Exposure Is Associated With Increased Oxidative Stress Among Feeding-Tolerant Critically Ill Patients: Results From the FEDOX Trial.,"BACKGROUND


Prospective randomized controlled trials (PRCTs) that found harm in patients receiving higher levels of energy exposure have been largely ignored, in part because of the lack of a known mechanism of harm.
OBJECTIVE


The current 7-day pilot study is a PRCT and post hoc analysis designed to explore the relationship between energy exposure and oxidative stress (as plasma total F2-isoprostanes) in mechanically ventilated intensive care unit patients with systemic inflammatory response syndrome.
METHODS


Thirty-five participants were randomized to receive either 100% or 40% of their estimated energy needs. Our intent-to-treat model found no differences in F2-isoprostanes between groups. A post hoc analysis revealed that on days when participants were in the highest tertile of daily kcal/kg, the real-time energy flow rate within 2 hours of the blood draw was predictive of increased oxidative stress. On these days, participants in the second or third vs the first tertile of real-time energy flow rate experienced a 41.8% (P = .006) or 26.5% (P = .001) increase in F2-isoprostane levels, respectively. This was confirmed through a within-group subanalysis restricted to participants with measurements on both sides of the median of real-time energy flow rate that found a 28.2% F2-isoprostane increase on days in the upper vs lower median of flow rate (P = .002).
CONCLUSION


The benefits of feeding may be more nuanced than previously suspected. Our findings imply a potential mechanism of harm in meeting the current recommendations for nutrition support in the critically ill that warrants further investigation.",2020,Our intent-to-treat model found no differences in F2-isoprostanes between groups.,"['mechanically ventilated intensive care unit patients with systemic inflammatory response syndrome', 'Feeding-Tolerant Critically Ill Patients', 'Thirty-five participants']",[],"['real-time energy flow rate', 'F2-isoprostane levels', 'Oxidative Stress', 'oxidative stress']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0949861', 'cui_str': 'F2-Isoprostanes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",35.0,0.249756,Our intent-to-treat model found no differences in F2-isoprostanes between groups.,"[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'McKeever', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Cienfuegos', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Rizzie', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Lateef', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Braunschweig', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, Illinois, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1776']
3636,31995262,Family-based treatment for adolescent anorexia nervosa: What happens to rates of comorbid diagnoses?,"OBJECTIVE


Rates of psychiatric comorbidity are elevated in adolescents with anorexia nervosa, but little is known about how psychiatric comorbidity changes following family-based treatment (FBT).
METHODS


Adolescents with anorexia nervosa (N = 107) enrolled in a randomized controlled trial comparing two forms of FBT completed the Mini International Neuropsychiatric Interview for Children and Adolescents at baseline and end of treatment. Analyses tested whether baseline comorbid diagnoses predicted the presence of comorbid diagnoses at end of treatment and if baseline eating disorder psychopathology impacted this association.
RESULTS


Rates of comorbid diagnoses decreased from 54% at baseline to 26% at end of treatment. Logistic regression analyses indicated that individuals with multiple comorbid diagnoses at baseline were more likely to meet criteria for a comorbid condition at end of treatment (b = 2.00, p < .05). Individuals with reported psychotropic medication use were less likely to meet criteria for a comorbid condition at end of treatment (b = -1.63, p = .04). Diagnostic rates for major depressive disorder, generalized anxiety disorder, and panic disorder/agoraphobia decreased following FBT.
CONCLUSIONS


Findings suggest that FBT for adolescent anorexia nervosa may aid in the resolution of some co-occurring psychiatric diagnoses. Continued research is needed to understand factors contributing to comorbid symptom improvement throughout treatment.",2020,"Diagnostic rates for major depressive disorder, generalized anxiety disorder, and panic disorder/agoraphobia decreased following FBT.
","['adolescent anorexia nervosa', 'Adolescents with anorexia nervosa (N = 107', 'adolescents with anorexia nervosa']","['FBT', 'FBT completed the Mini International Neuropsychiatric Interview']","['Diagnostic rates', 'Rates of comorbid diagnoses', 'generalized anxiety disorder, and panic disorder/agoraphobia']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}]",107.0,0.102058,"Diagnostic rates for major depressive disorder, generalized anxiety disorder, and panic disorder/agoraphobia decreased following FBT.
","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Trainor', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Gorrell', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Hughes', 'Affiliation': ""The University of Melbourne, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sawyer', 'Affiliation': ""The University of Melbourne, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Burton', 'Affiliation': ""The University of Melbourne, Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le  Grange', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2725']
3637,31996235,Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.,"INTRODUCTION


Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acute treatment phase, this is rarely available in subsequent phases. Internet interventions for breast cancer survivors could provide additional psychological support, as they are easily accessible and may be effective. However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population. This trial aims to test whether Optimune, a novel Internet intervention we developed for that purpose, leads to improvements in quality of life and relevant lifestyle habits over the course of 3 to 6 months.
METHODS


This randomized controlled trial (RCT) will include 360 female breast cancer survivors who have completed the active tumour eradication phase. Participants will be recruited from various settings, including web-based advertisements and Internet forums in German-speaking countries. The main inclusion criteria are a breast cancer diagnosis less than 5 years ago and completion of acute treatment at least 1 month ago, as verified by discharge letter from an oncology treatment centre. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to Optimune after a delay of 3 months (CAU/wait list control), or (2) a treatment group that may also use CAU and will receive 12-month access to Optimune immediately after randomization. The three primary endpoints are quality of life, physical activity and diet quality, assessed with the World Health Organization Quality of Life Questionnaire, the International Physical Activity Questionnaire and the Food Quality Questionnaire, at 3 months post-baseline; secondary outcomes include cancer-related fatigue, emotional stress, depression, anxiety, fear of progression, insomnia, usefulness of the programme and negative treatment effects. Online assessments are conducted at baseline (T0), 3 months (T1) and 6 months (T2).
DISCUSSION


Results of this RCT are expected to extend the body of knowledge with regard to the effectiveness of CBT-based Internet interventions for female breast cancer survivors.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03643640. Registered on 23 August 2018.",2020,"However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population.","['Participants will be recruited from various settings, including web-based advertisements and Internet forums in German-speaking countries', 'breast cancer diagnosis less than 5\u2009years ago and completion of acute treatment at least 1\u2009month ago, as verified by discharge letter from an oncology treatment centre', '360 female breast cancer survivors who have completed the active tumour eradication phase', 'breast cancer survivors', 'female breast cancer survivors']","['novel Internet intervention', 'Internet interventions', 'CBT-based Internet interventions', 'control group, in which they receive care as usual (CAU) and are given access to Optimune after a delay of 3\u2009months (CAU/wait list control), or (2) a treatment group that may also use CAU']","['cancer-related fatigue, emotional stress, depression, anxiety, fear of progression, insomnia, usefulness of the programme and negative treatment effects', 'quality of life, physical activity and diet quality, assessed with the World Health Organization Quality of Life Questionnaire, the International Physical Activity Questionnaire and the Food Quality Questionnaire', 'quality of life and relevant lifestyle habits']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0086209', 'cui_str': 'Emotional Stress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0920525', 'cui_str': 'Food Quality'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",360.0,0.162803,"However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Holtdirk', 'Affiliation': 'Research Department, Gaia Group, Hans-Henny-Jahnn Weg 53, 22085, Hamburg, Germany. franziska.holtdirk@gaia-group.com.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mehnert', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology, University Hospital of Leipzig, Philipp-Rosenthal-Str. 55, 04103, Leipzig, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Research Department, Gaia Group, Hans-Henny-Jahnn Weg 53, 22085, Hamburg, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Research Department, Gaia Group, Hans-Henny-Jahnn Weg 53, 22085, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Watzl', 'Affiliation': 'Technical University of Dortmund, Leibniz Research Centre (IfADo), Ardeystraße 67, 44139, Dortmund, Germany.'}]",Trials,['10.1186/s13063-019-3987-y']
3638,31992358,Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial).,"BACKGROUND


After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment.
METHODS


The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes.
DISCUSSION


The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial.
TRIAL REGISTRATION


Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.",2020,The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness.,"['128 patients', 'patients with fecal incontinence or anorectal dysfunction after LAR', 'All patients that underwent LAR are recruited from the participating hospitals and randomized for either', 'rectal cancer', 'rectal cancer patients after sphincter-saving surgery compared to standard treatment']","['low anterior resection (LAR', 'PFR', 'standard treatment or a standardized PFR program', 'Pelvic floor rehabilitation']","['functional outcome and quality of life', 'Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness', 'fecal incontinence, quality of life, and costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0442000', 'cui_str': 'Lower anterior (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030735', 'cui_str': 'PEFR'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.2689,The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness.,"[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Kalkdijk-Dijkstra', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'J A G', 'Initials': 'JAG', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Isala Clinics, Zwolle, The Netherlands.'}, {'ForeName': 'P M A', 'Initials': 'PMA', 'LastName': 'Broens', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trzpis', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'J P E N', 'Initials': 'JPEN', 'LastName': 'Pierie', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Klarenbeek', 'Affiliation': 'Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands. Bastiaan.Klarenbeek@radboudumc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-4043-7']
3639,31969264,Cognitive changes after tDCS and escitalopram treatment in major depressive disorder: Results from the placebo-controlled ELECT-TDCS trial.,"BACKGROUND


Cognitive deficits in major depressive disorder (MDD) are associated with low quality of life and higher suicide risk. Antidepressant drugs have modest to null effects in improving such deficits. Therefore, we investigated the cognitive effects of transcranial direct current stimulation (tDCS), which is a promising antidepressant non-pharmacological intervention, in MDD.
METHODS


An exploratory analysis on cognitive performance was conducted in 243 depressed patients from the Escitalopram vs. Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS), a sham-controlled study comparing the efficacy of tDCS vs. escitalopram. A neuropsychological battery was applied at baseline and endpoint (10 weeks of treatment) to create composite cognitive scores (processing speed, working memory, and verbal fluency). Linear mixed regression models were used to evaluate changes according to intervention groups, adjusted for confounding variables (age, years of schooling, gender, and benzodiazepine use) and depression improvement.
RESULTS


No cognitive deterioration was observed in any group. Patients receiving tDCS presented reduced practice gains compared to placebo in processing speed. In patients receiving escitalopram vs. placebo and in the subgroup of clinical responders (>50% depression improvement from baseline), those receiving tDCS vs. placebo presented increased performance in verbal fluency. No significant differences between tDCS and escitalopram groups were detected.
LIMITATIONS


Absence of healthy controls.
CONCLUSION


Prefrontal tDCS did not lead to cognitive deficits in depressed patients, although it reduced practice effects in processing speed. tDCS responders presented increased performance in verbal fluency. Further investigation of tDCS cognitive effects in depression is warranted.",2020,No cognitive deterioration was observed in any group.,"['healthy controls', 'major depressive disorder (MDD', '243 depressed patients from the', 'major depressive disorder']","['tDCS and escitalopram treatment', 'tDCS vs. placebo', 'placebo', 'tDCS vs. escitalopram', 'transcranial direct current stimulation (tDCS', 'escitalopram vs. placebo', 'tDCS', 'Escitalopram vs. Electric Current Therapy']","['cognitive deterioration', 'Cognitive changes', 'practice gains', 'composite cognitive scores (processing speed, working memory, and verbal fluency', 'performance in verbal fluency', 'cognitive deficits', 'cognitive performance']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",243.0,0.0822026,No cognitive deterioration was observed in any group.,"[{'ForeName': 'Marina L', 'Initials': 'ML', 'LastName': 'Moreno', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil; Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Munich, Germany; Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Leopoldstraße 13, 80802, Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Infanteriestraße 11A, 80797, Munich, Germany.'}, {'ForeName': 'Laiss', 'Initials': 'L', 'LastName': 'Bertola', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil.'}, {'ForeName': 'Claudia K', 'Initials': 'CK', 'LastName': 'Suemoto', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil.'}, {'ForeName': 'Lais B', 'Initials': 'LB', 'LastName': 'Razza', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriano H', 'Initials': 'AH', 'LastName': 'Moffa', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil; School of Psychiatry, University of New South Wales, Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Beatriz P', 'Initials': 'BP', 'LastName': 'Veronezi', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil.'}, {'ForeName': 'Luara', 'Initials': 'L', 'LastName': 'Tort', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil; Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'Nogueira', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil.'}, {'ForeName': 'Wagner F', 'Initials': 'WF', 'LastName': 'Gattaz', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renerio', 'Initials': 'R', 'LastName': 'Fraguas', 'Affiliation': 'Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Departamento de Clínica Médica, Faculdade de Medicina da USP & Hospital Universitário da USP, São Paulo, Brazil; Departamento e Instituto de Psiquiatria, Faculdade de Medicina da USP & Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Universidade de São Paulo, São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Journal of affective disorders,['10.1016/j.jad.2019.12.009']
3640,31969269,A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression.,"BACKGROUND


The safety and efficacy of cariprazine, a dopamine D 3 -preferring D 3 /D 2  receptor partial agonist and serotonin 5-HT 1A  receptor partial agonist, was evaluated in 4 randomized, double-blind, placebo-controlled trials in patients with bipolar depression.
METHODS


Safety and tolerability were evaluated in 2 post hoc analyses. Modal dose analysis: pooled data from all 4 flexible/fixed-dose trials (dose groups: <1.5, 1.5, 3 mg/d). Fixed-dose analysis: pooled data from 2 identically designed fixed-dose trials (1.5 and 3 mg/d dose groups).
RESULTS


The modal dose and fixed-dose analyses evaluated data from 1775 and 970 patients, respectively. Cariprazine was generally safe and well tolerated; study completion rates were 78% and 82% in the modal dose and fixed-dose analyses, respectively. In modal dose analysis, treatment-emergent adverse events (TEAEs) occurred in 60% of overall cariprazine- and 55% of placebo-treated patients; nausea (8% vs 3%) and akathisia (7% vs 2%) occurred in ≥5% of cariprazine patients and twice the rate of placebo. Metabolic changes were small and generally similar for cariprazine and placebo; mean increase in glucose was 3.1 mg/dL for cariprazine and 2.6 mg/dL for placebo. Fixed-dose and modal dose findings were generally consistent; values for most metabolic parameters were slightly higher for fixed-dose 3 mg/d versus 1.5 mg/d.
LIMITATIONS


Post hoc analyses, modal dose groups, short treatment duration.
CONCLUSIONS


In modal dose (0.25-3 mg/d) and fixed-dose (1.5 and 3 mg/d) analyses, cariprazine was generally safe and well tolerated in the treatment of bipolar depression. Slightly improved tolerability was observed with fixed-dose cariprazine 1.5 mg/d versus 3 mg/d.
TRIAL REGISTRATION


clinicaltrials.gov NCT00852202, NCT01396447, NCT02670538, NCT02670551.",2020,"Cariprazine was generally safe and well tolerated; study completion rates were 78% and 82% in the modal dose and fixed-dose analyses, respectively.",['patients with bipolar depression'],"['Cariprazine', 'placebo', 'cariprazine, a dopamine D 3', 'preferring', 'cariprazine']","['safety and tolerability', 'tolerability', 'nausea', 'akathisia', 'Metabolic changes', 'safe and well tolerated', 'safe and well tolerated; study completion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}]","[{'cui': 'C2936870', 'cui_str': 'cariprazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",,0.294374,"Cariprazine was generally safe and well tolerated; study completion rates were 78% and 82% in the modal dose and fixed-dose analyses, respectively.","[{'ForeName': 'Willie R', 'Initials': 'WR', 'LastName': 'Earley', 'Affiliation': 'Allergan, Madison, NJ, USA. Electronic address: willie.earley@allergan.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Burgess', 'Affiliation': 'Allergan, Madison, NJ, USA.'}, {'ForeName': 'Ludmyla', 'Initials': 'L', 'LastName': 'Rekeda', 'Affiliation': 'Allergan, Madison, NJ, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Hankinson', 'Affiliation': 'Allergan, Madison, NJ, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Toronto Western Research Institute, Toronto, Canada.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'VA Health Care System, Palo Alto, CA, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'University Hospitals Cleveland Medical Center, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.098']
3641,31969275,A 12-week multidomain intervention for late-life depression: a community-based randomized controlled trial.,"BACKGROUND


Given that current unimodal strategies for treating late-life depression are insufficient, the awareness of the necessity and importance of multidomain intervention has increased. We assessed the efficacy of multidomain intervention in reducing symptoms of late-life depression.
METHODS


This was a 12-week community-based randomized controlled trial in 78 older adults diagnosed with major depressive disorder. Participants were randomly assigned to the multidomain intervention or supportive therapy group. We provided four home visits and 12 telephone calls over 12 weeks. Four therapeutic approaches (physical activity, healthy diet, social activity, and brief cognitive restructuring) were incorporated into the multidomain intervention. The primary outcome was the change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Secondarily, we investigated changes in resting-state functional connectivity.
RESULTS


The MADRS total score was reduced more in the multidomain intervention group than in the supportive therapy group during the 12 weeks (intervention × time interaction, P = =0.007). After correction for multiple comparisons, the multidomain intervention group exhibited a lower MADRS total score at week 12 (score difference 5.117; P = =0.029). At follow-up, the multidomain intervention group also exhibited less functional connectivity between the posterior cingulate cortex and left inferior parietal lobule within the default mode network (FDR < 0.1).
LIMITATIONS


Caution is needed in the interpretation of the results, considering the small sample size and high percentage of female participants.
CONCLUSIONS


A 12-week multidomain intervention resulted in a greater reduction of depressive symptoms among the elderly with major depressive disorder than their counterparts who received supportive therapy.",2020,"The MADRS total score was reduced more in the multidomain intervention group than in the supportive therapy group during the 12 weeks (intervention × time interaction, P = =0.007).","['late-life depression', '78 older adults diagnosed with major depressive disorder']","['multidomain intervention', 'supportive therapy', 'multidomain intervention or supportive therapy group']","['MADRS total score', 'depressive symptoms', 'functional connectivity', 'change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",78.0,0.0664884,"The MADRS total score was reduced more in the multidomain intervention group than in the supportive therapy group during the 12 weeks (intervention × time interaction, P = =0.007).","[{'ForeName': 'Hyun Woong', 'Initials': 'HW', 'LastName': 'Roh', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea; Department of Brain Science, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Chang Hyung', 'Initials': 'CH', 'LastName': 'Hong', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Hyun Kook', 'Initials': 'HK', 'LastName': 'Lim', 'Affiliation': ""Department of Psychiatry, The Catholic University of Korea College of Medicine, Yeouido St. Mary's Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Ki Jung', 'Initials': 'KJ', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Ajou Good Hospital, Suwon, Republic of Korea.'}, {'ForeName': 'Haena', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Na-Rae', 'Initials': 'NR', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Jin Wook', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Kang Soo', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, CHA University School of Medicine, CHA Bundang Medical Center, Bundang, Republic of Korea.'}, {'ForeName': 'Sun-Mi', 'Initials': 'SM', 'LastName': 'Cho', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Bumhee', 'Initials': 'B', 'LastName': 'Park', 'Affiliation': 'Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, Republic of Korea; Office of Biostatistics, Ajou University School of Medicine, Suwon, Republic of Korea. Electronic address: bhpark@ajou.ac.kr.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Son', 'Affiliation': 'Department of Psychiatry, Ajou University School of Medicine, Suwon, Republic of Korea. Electronic address: sjsonpsy@ajou.ac.kr.'}]",Journal of affective disorders,['10.1016/j.jad.2019.12.013']
3642,31667584,Feasibility of ultrasound-guided lumbar epidural access using paramedian transverse scanning with the needle in-plane: a comparison with paramedian sagittal scanning.,"BACKGROUND AND OBJECTIVES


The present study was designed to compare the feasibility of ultrasound (US)-guided lumbar epidural access using paramedian sagittal scanning (PMSS) and paramedian transverse scanning (PMTS) approaches.
METHODS


Fifty patients undergoing surgery of the lower extremities were randomly allocated into 2 groups. The patients in PMSS group received PMSS-guided in-plane epidural access, whereas patients in PMTS group received PMTS-guided in-plane epidural access. The US visibility of neuraxial structures and of Tuohy needle during US scout scan, procedure duration, the number of attempts to access epidural space, Tuohy needle puncture depth in the epidural space, and extent of sensory block after spinal block between two groups were compared.
RESULTS


The US visibility of Tuohy needle and neuraxial structures was comparable between two groups. There was an overall decrease in procedure duration in the PMTS group relative to the PMSS group (360 ± 42 vs. 490 ± 38 s). The number of attempts needed to access the epidural space in PMSS group was significantly higher than in PMTS group. Distances between the epidural space and the puncture site in PMSS group and PMTS group showed a significant difference (7.13 ± 0.67 vs. 5.24 ± 0.21 cm). No significant differences in the extent of sensory block after spinal block were observed.
CONCLUSIONS


We found that PMTS approach was superior as a means of achieving epidural access relative to the PMSS approach, since PMTS approach can be conducted more quickly given shorter path of the needle and less times needed for epidural access during this procedure.
CLINICAL TRIAL REGISTRATION


Chinese Clinical Trial Registry, clinical trial number ChiCTR1800015815, date of registration April 24, 2018.",2020,The US visibility of Tuohy needle and neuraxial structures was comparable between two groups.,['Fifty patients undergoing surgery of the lower extremities'],"['paramedian sagittal scanning', 'PMSS', 'paramedian transverse scanning', 'ultrasound (US)-guided lumbar epidural access using paramedian sagittal scanning (PMSS) and paramedian transverse scanning (PMTS', 'PMTS-guided in-plane epidural access', 'ultrasound-guided lumbar epidural access', 'PMSS-guided in-plane epidural access']","['sensory block after spinal block', 'number of attempts needed to access the epidural space', 'procedure duration', 'US visibility of Tuohy needle and neuraxial structures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0228134', 'cui_str': 'Epidural Space'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}]",50.0,0.0479317,The US visibility of Tuohy needle and neuraxial structures was comparable between two groups.,"[{'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Pharmaceutical Science, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Miyun Hospital, Beijing, China.'}, {'ForeName': 'Danxu', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China. wangyun129@ccmu.edu.cn.'}]",Journal of anesthesia,['10.1007/s00540-019-02704-7']
3643,32196623,Effect of low-dose aspirin on serum uric acid levels in Chinese individuals over 60: subanalysis of a multicentre randomized clinical trial.,"OBJECTIVE


Uric acid is considered a biomarker for cardiovascular risk. Only a few studies have investigated the effect of aspirin on serum uric acid (SUA) levels with contradictory results. The present study evaluated the effect of aspirin on SUA levels in Chinese individuals over 60 years of age.
PATIENTS AND METHODS


Subjects over 60 with coronary artery disease or multiple cardiovascular risk factors were enrolled in a multicentre randomized clinical trial. Eligible subjects were randomized to receive 50 mg or 100 mg aspirin daily. Levels of arachidonic acid-induced platelet aggregation performed by light transmission aggregometry (LTA-AA) and SUA were measured at randomization and two weeks thereafter. In this subanalysis, subjects without aspirin use prior to enrolment were chosen.
RESULTS


A total of 446 subjects were analysed, of which 151 subjects took 50 mg aspirin, and 295 took 100 mg aspirin. Hyperuricaemia was present in 23.3% (104/446) of subjects at baseline. LTA-AA levels were significantly reduced in subjects after taking aspirin for two weeks (both 50 mg and 100 mg, p < 0.001). SUA levels were decreased after aspirin administration (311 μmol/L vs. 302 μmol/L, p < 0.001). Further analysis showed SUA levels were unchanged in normouricaemic subjects (284 μmol/L vs. 280 μmol/L, p > 0.05), while slightly decreased in hyperuricaemic subjects (429 μmol/L vs. 392 μmol/L, p < 0.001).
CONCLUSIONS


Our study showed that both 50 mg and 100 mg aspirin significantly inhibited platelet aggregation. Aspirin treatment for two weeks showed no hyperuricaemic effect in people over 60. SUA levels were unchanged after taking aspirin in normouricaemic subjects but decreased in hyperuricaemic subjects. This trial was registered at www. chictr.org.cn as ChiCTR1800018517.",2020,"LTA-AA levels were significantly reduced in subjects after taking aspirin for two weeks (both 50 mg and 100 mg, p < 0.001).","['Chinese individuals over 60', 'Eligible subjects', 'Subjects over 60 with coronary artery disease or multiple cardiovascular risk factors', 'Chinese individuals over 60 years of age', 'A total of 446 subjects were analysed, of which 151 subjects took 50 mg']","['aspirin', 'low-dose aspirin', 'Aspirin']","['Hyperuricaemia', 'serum uric acid (SUA) levels', 'LTA-AA levels', 'SUA levels', 'hyperuricaemic effect', 'serum uric acid levels', 'platelet aggregation']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2729610', 'cui_str': 'LTA'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}]",446.0,0.103943,"LTA-AA levels were significantly reduced in subjects after taking aspirin for two weeks (both 50 mg and 100 mg, p < 0.001).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatrics, Peking University First Hospital, Beijing, China. liumeilin@hotmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'X-H', 'Initials': 'XH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'W-Y', 'Initials': 'WY', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'W-W', 'Initials': 'WW', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'M-L', 'Initials': 'ML', 'LastName': 'Liu', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202003_20544']
3644,32139762,Exercise intensity and physical fitness modulate lipoproteins profile during acute aerobic exercise session.,"Physical inactivity has emerged as an important cardiometabolic risk factor; however, the beneficial impacts of physical exercise according physical fitness status are still unclear. To analyze the lipoproteins and immune-endocrine response to acute aerobic exercise sessions performed at different intensities according physical fitness status and evaluated the gene expression in monocyte cells. Twelve individuals, divided into Low and High VO 2max,  performed three randomized acute exercise sessions at low (<60% VO 2max ), moderate (60-75% VO 2max ), and high (>90% VO 2max ) intensities. Blood samples were collected pre, immediately post, and 60 minutes post-exercise to analyze NEFA, triacylglycerol, non-HDL-c, HDL-c, PAI-1, leptin and adiponectin concentrations. Blood samples were collected from another set of twelve individuals for use in monocyte cell cultures to analyze L-CAT, CETP, and AMPK gene expressions. Low VO 2max  group pre-exercise exhibited higher postprandial leptin and total cholesterol concentrations than High VO 2max  group (p < 0.05). Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p < 0.05, for both), but for PAI-1 levels was decreased (p < 0.05) only for the Low VO 2max  group. Triacylglycerol levels decreased after all exercise sessions (p < 0.05) for both groups, and HDL-c exhibited decrease during moderate-intensity (p < 0.05), but this scenario was attenuated in Low VO 2max  group. Low VO 2max  individuals exhibit some metabolic-endocrine disruption, and acute aerobic exercise sessions performed at low, moderate, and high intensities are capable of modulating metabolic-endocrine parameters, mainly at high-intensity, in a physical fitness-dependent way, given that Low VO 2max  group was more responsive and seem to be able to appropriate more exercise-related benefits.",2020,"Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p < 0.05, for both), but for PAI-1 levels was decreased (p < 0.05) only for the Low VO 2max  group.","['Twelve individuals, divided into Low and High VO 2max,  performed three randomized']","['acute exercise sessions', 'acute aerobic exercise sessions', 'acute aerobic exercise session']","['moderate-intensity', 'PAI-1 levels', 'leptin and NEFA levels', 'postprandial leptin and total cholesterol concentrations', 'Triacylglycerol levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0139516,"Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p < 0.05, for both), but for PAI-1 levels was decreased (p < 0.05) only for the Low VO 2max  group.","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil. ba.antunes2@gmail.com.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Universidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Fisiologia, São Paulo, Brazil.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Immunometabolism Research Group, Department of Cell Biology and Development, Institute of Biomeical Science of University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-61039-6']
3645,32195538,Single Nucleotide Polymorphisms Related to Lipoprotein Metabolism Are Associated with Blood Lipid Changes following Regular Avocado Intake in a Randomized Control Trial among Adults with Overweight and Obesity.,"BACKGROUND


Avocados are rich in unsaturated fat and fiber; clinical trials have investigated their effects on metabolic disease. There is high variability in individual changes following avocado consumption, which may be in part due to individual genetic differences.
OBJECTIVE


Secondary analyses of the Persea americana for Total Health (PATH) Study were used to examine how single nucleotide polymorphisms (SNPs) impact blood lipid changes following a daily meal containing avocado compared with control.
METHODS


Adults (n = 115, 37% male) aged 25-45 y with overweight and obesity were randomly assigned to receive a daily isocaloric meal with (intervention) or without (control) a standardized amount (males: 175 g; females: 140 g) of avocado for 12 wk. Control meals were higher in saturated fat (17% of energy compared with 7%) and lower in fiber (4 g compared with 16 g) than intervention meals. Whole venous blood was taken at baseline and 12 wk to determine total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and triglyceride (TG) concentrations. Seventeen SNPs in 10 genes related to lipoprotein metabolism were genotyped. Effects of SNP, diet, and SNP-diet interactions were determined using general linear models.
RESULTS


No group-by-time effects were detected for changes in TC (P = 0.96), HDL cholesterol (P = 0.28), or TG (P = 0.06) over 12 wk. Three SNP-diet interactions were associated with final TC concentrations: ANGPTL3-rs10889337 (P = 0.01), ANGPTL4-rs2278236 (P = 0.02), and CD36-rs10499859 (P = 0.01). SNPs in GCKR and LPL were associated with TC changes (P = 0.01). The interaction between GCKR-rs1260326 and diet was such that C-homozygotes receiving avocado (n = 23) had final TC concentrations that were significantly lower than the C-homozygotes in the control group (n = 20) (P = 0.02).
CONCLUSIONS


Results from these exploratory analyses indicate that avocado consumption may help manage dyslipidemia in adults with overweight and obesity; however, effectiveness may differ by genetic profile. Understanding the role of genetic variation in variability following dietary intervention can potentially inform personalized nutrition recommendations.",2020,"No group-by-time effects were detected for changes in TC (P = 0.96), HDL cholesterol (P = 0.28), or TG (P = 0.06) over 12 wk.","['115, 37% male) aged 25-45 y with overweight and obesity', 'Adults (n\xa0', 'Adults with Overweight and Obesity', 'adults with overweight and obesity']","['dietary intervention', 'daily isocaloric meal with (intervention) or without (control) a standardized amount (males: 175\xa0g; females: 140\xa0g) of avocado']","['Lipoprotein Metabolism', 'Blood Lipid Changes', 'final TC concentrations: ANGPTL3-rs10889337', 'changes in TC', 'final TC concentrations', 'HDL cholesterol', 'total cholesterol (TC), high-density lipoprotein (HDL) cholesterol, and triglyceride (TG) concentrations', 'TC changes', 'Total Health (PATH', 'lipoprotein metabolism']","[{'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}]","[{'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0342006,"No group-by-time effects were detected for changes in TC (P = 0.96), HDL cholesterol (P = 0.28), or TG (P = 0.06) over 12 wk.","[{'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Hannon', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Edwards', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Sharon V', 'Initials': 'SV', 'LastName': 'Thompson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Reeser', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Holscher', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Teran-Garcia', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa054']
3646,32005282,Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial).,"BACKGROUND


Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors and one of the most common chronic lung diseases. It has a poor prognosis, especially in preterm infants. However, effective therapies for this disease are lacking. Stem-cell therapy is a promising way to improve lung injury and abnormal alveolarization, and the human umbilical cord (hUC) is a good source of mesenchymal stem cells (MSCs), which have demonstrated efficacy in other diseases. We hypothesized that intravenously administered allogeneic hUC-MSCs are safe and effective for severe BPD.
METHODS


The MSC-BPD trial is a randomized, single-center, open-label, dose-escalation, phase-II trial designed to investigate the safety and efficacy of hUC-MSCs in children with severe BPD. In this study, 72 patients will be enrolled and randomly divided into two intervention groups and one control group. Patients in the intervention groups will receive a low dose of hUC-MSCs (n = 24; 2.5 million cells/kg) or a high dose of hUC-MSCs (n = 24; 5 million cells/kg) in combination with traditional supportive treatments for BPD. The patients in the control group (n = 24) will be treated with traditional supportive treatments alone without hUC-MSCs. The primary outcome measures will be cumulative duration of oxygen therapy. Follow-up assessments will be performed at 1, 3, 6, 12, and 24 months post intervention, and the key outcome during follow-up will be changes on chest radiography. Statistical analyses will evaluate the efficacy of the hUC-MSC treatment.
DISCUSSION


This will be the first randomized controlled trial to evaluate the safety and efficacy of intravenously administered hUC-MSCs in children with severe BPD. Its results should provide a new evidence-based therapy for severe BPD.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03601416. Registered on 26 July 2018.",2020,This will be the first randomized controlled trial to evaluate the safety and efficacy of intravenously administered hUC-MSCs in children with severe BPD.,"['severe bronchopulmonary dysplasia in children', 'children with severe BPD', '72 patients', 'Bronchopulmonary dysplasia (BPD', 'preterm infants']","['traditional supportive treatments alone without hUC-MSCs', 'allogeneic hUC-MSCs', 'hUC-MSCs (n\u2009=\u200924; 5 million cells/kg) in combination with traditional supportive treatments for BPD', 'Stem-cell therapy', 'hUC-MSCs', 'Allogeneic human umbilical cord-derived mesenchymal stem cells']","['safety and efficacy', 'cumulative duration of oxygen therapy']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]",72.0,0.115223,This will be the first randomized controlled trial to evaluate the safety and efficacy of intravenously administered hUC-MSCs in children with severe BPD.,"[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Yunqiu', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Ou', 'Initials': 'O', 'LastName': 'Zhou', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Xianhong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Daiyin', 'Initials': 'D', 'LastName': 'Tian', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Qubei', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Shu', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Enmei', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Chengjun', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China. cqxinshenger@163.com.""}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': ""Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, No 136, 2nd Zhongshan Rd, Yuzhong District, Chongqing, 400014, China. danieljh@163.com.""}]",Trials,['10.1186/s13063-019-3935-x']
3647,32164669,Variations in factors associated with healthcare providers' intention to engage in interprofessional shared decision making in home care: results of two cross-sectional surveys.,"BACKGROUND


DOLCE (Improving Decision making On Location of Care with the frail Elderly and their caregivers) was a post-intervention clustered randomised trial (cRT) to assess the effect of training home care teams on interprofessional shared decision-making (IP-SDM). Alongside the cRT, we sought to monitor healthcare providers' level of behavioural intention to engage in an IP-SDM approach and to identify factors associated with this intention.
METHODS


We conducted two cross-sectional surveys in the province of Quebec, Canada, one each at cRT entry and exit. Healthcare providers (e.g. nurses, occupational therapists and social workers) in the 16 participating intervention and control sites self-completed an identical paper-based questionnaire at entry and exit. Informed by the Integrated model for explaining healthcare professionals' clinical behaviour by Godin et al. (2008), we assessed their behavioural intention to engage in IP-SDM to support older adults and caregivers of older adults with cognitive impairment to make health-related housing decisions. We also assessed psychosocial variables underlying their behavioural intention and collected sociodemographic data. We used descriptive statistics and linear mixed models to account for clustering.
RESULTS


Between 2014 and 2016, 271 healthcare providers participated at study entry and 171 at exit. At entry, median intention level was 6 in a range of 1 (low) to 7 (high) (Interquartile range (IQR): 5-6.5) and factors associated with intention were social influence (β = 0.27, P <  0.0001), beliefs about one's capabilities (β = 0.43, P <  0.0001), moral norm (β = 0.31, P <  0.0001) and beliefs about consequences (β = 0.21, P <  0.0001). At exit, median intention level was 5.5 (IQR: 4.5-6.5). Factors associated with intention were the same but did not include moral norm. However, at exit new factors were kept in the model: working in rehabilitation (β = - 0.39, P = 0.018) and working as a technician (β = - 0.41, P = 0.069) (compared to as a social worker).
CONCLUSION


Intention levels were high but decreased from entry to exit. Factors associated with intention also changed from study entry to study exit. These findings may be explained by the major restructuring of the health and social care system that took place during the 2 years of the study, leading to rapid staff turnover and organisational disturbance in home care teams. Future research should give more attention to contextual factors and design implementation interventions to withstand the disruption of system- and organisational-level disturbances.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT02244359). Registered on September 19th, 2014.",2020,"Alongside the cRT, we sought to monitor healthcare providers' level of behavioural intention to engage in an IP-SDM approach and to identify factors associated with this intention.
","['271 healthcare providers participated at study entry and 171 at exit', 'older adults and caregivers of older adults with cognitive impairment to make health-related housing decisions', 'Between 2014 and 2016', 'two cross-sectional surveys in the province of Quebec, Canada, one each at cRT entry and exit', 'Healthcare providers (e.g. nurses, occupational therapists and social workers) in the 16 participating intervention and control sites self-completed an identical paper-based questionnaire at entry and exit']",['behavioural intention to engage in IP-SDM'],['median intention level'],"[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0643808', 'cui_str': 'SDM'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0762471,"Alongside the cRT, we sought to monitor healthcare providers' level of behavioural intention to engage in an IP-SDM approach and to identify factors associated with this intention.
","[{'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Quebec, Canada.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Haesebaert', 'Affiliation': 'Université de Lyon, Université Claude Bernard Lyon 1, Université Saint-Étienne, HESPER EA 7425, F-69008 Lyon, F-42023, Saint-Etienne, France.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'Ottawa Hospital Research Institute and Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Brière', 'Affiliation': 'Centre intégré universitaire en santé et services sociaux de la Capitale-Nationale, Quebec, Canada.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Freitas', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Quebec, Canada.""}, {'ForeName': 'Louis-Paul', 'Initials': 'LP', 'LastName': 'Rivest', 'Affiliation': 'Department of Mathematics and Statistics, Université Laval, Quebec, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': ""Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Quebec, Canada. France.Legare@mfa.ulaval.ca.""}]",BMC health services research,['10.1186/s12913-020-5064-3']
3648,32164673,"Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial.","Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response. Moreover, prior therapeutic trials have suggested improved outcomes in these patients treated with either sulfamethoxazole/ trimethoprim or doxycycline. These trials have been limited by methodological concerns. This trial addresses the primary hypothesis that long-term treatment with antimicrobial therapy increases the time-to-event endpoint of respiratory hospitalization or all-cause mortality compared to usual care treatment in patients with IPF. We invoke numerous innovative features to achieve this goal, including: 1) utilizing a pragmatic randomized trial design; 2) collecting targeted biological samples to allow future exploration of 'personalized' therapy; and 3) developing a strong partnership between the NHLBI, a broad range of investigators, industry, and philanthropic organizations. The trial will randomize approximately 500 individuals in a 1:1 ratio to either antimicrobial therapy or usual care. The site principal investigator will declare their preferred initial antimicrobial treatment strategy (trimethoprim 160 mg/ sulfamethoxazole 800 mg twice a day plus folic acid 5 mg daily or doxycycline 100 mg once daily if body weight is < 50 kg or 100 mg twice daily if ≥50 kg) for the participant prior to randomization. Participants randomized to antimicrobial therapy will receive a voucher to help cover the additional prescription drug costs. Additionally, those participants will have 4-5 scheduled blood draws over the initial 24 months of therapy for safety monitoring. Blood sampling for DNA sequencing and genome wide transcriptomics will be collected before therapy. Blood sampling for transcriptomics and oral and fecal swabs for determination of the microbiome communities will be collected before and after study completion. As a pragmatic study, participants in both treatment arms will have limited in-person visits with the enrolling clinical center. Visits are limited to assessments of lung function and other clinical parameters at time points prior to randomization and at months 12, 24, and 36. All participants will be followed until the study completion for the assessment of clinical endpoints related to hospitalization and mortality events. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02759120.",2020,Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response.,"['patients with idiopathic pulmonary fibrosis (IPF', 'participants in both treatment arms will have limited in-person visits with the enrolling clinical center', 'Idiopathic Pulmonary Fibrosis (CleanUP-IPF', '500 individuals in a 1:1 ratio to either antimicrobial therapy or usual care', 'patients with IPF']","['sulfamethoxazole 800', 'antimicrobial therapy strategy', 'sulfamethoxazole/ trimethoprim or doxycycline', 'doxycycline', 'trimethoprim 160', 'antimicrobial therapy ', 'antimicrobial therapy']","['time-to-event endpoint of respiratory hospitalization or all-cause mortality', 'hospitalization and mortality events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0038689', 'cui_str': 'Sulfamethoxazole'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041041', 'cui_str': 'Trimethoprim'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.132871,Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response.,"[{'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. kevin.anstrom@duke.edu.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary Medicine, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, University of Michigan Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Rex H', 'Initials': 'RH', 'LastName': 'Edwards', 'Affiliation': 'Pulmonary Fibrosis Foundation, Chicago, IL, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baucom', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Clausen', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Durheim', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Dong-Yun', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Kirchner', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Oldham', 'Affiliation': 'UC Davis, Pulmonary, Critical Care, and Sleep Medicine, Davis, California, USA.'}, {'ForeName': 'Laurie D', 'Initials': 'LD', 'LastName': 'Snyder', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wilson', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Yow', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Division of Pulmonary Medicine, Weill-Cornell Medical Center, Cornell University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory research,['10.1186/s12931-020-1326-1']
3649,32027349,Association of Visit Adherence and Visual Acuity in Patients With Neovascular Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial.,"Importance


Visit adherence has been shown to play a significant role in patient health outcomes. The effect of missing visits on visual acuity (VA) in individuals with neovascular age-related macular degeneration has yet to be characterized.
Objective


To quantify the association between patients' adherence to randomized clinical trial visits and VA in individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics.
Design, Setting, and Participants


This is a secondary analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial randomized clinical trial. Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009. The 2-year study protocol required 1 visit every 4 weeks (every 21-35 days for a total of 26 visits) for monthly vs pro re nata treatments of bevacizumab vs ranibizumab. Analysis took place from November 2018 through May 2019.
Exposures


Visit adherence was measured in 4 ways: total number of missed visits, average number of days (avg days) between each visit, longest duration in days (max days) between visits, and visit constancy (the tally of 3-month periods with at least 1 visit attended). Average and max days were also categorized as on time (28-35 days), late (36-60 days), and very late (>60 days).
Main Outcomes and Measures


Change in Early Treatment Diabetic Retinopathy Study VA between the baseline and the last visit. Linear multivariate regression models were applied to analyze the association between visit adherence and change in VA, controlling for age, sex, baseline VA, anti-vascular endothelial growth factor drug, number of injections, and dosing regimen.
Results


Of 1178 patients, the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women. The mean (SD) number of missed visits was 2.4 (3.1). Overall, 1091 patients (92.6%) had complete visit constancy during the entire study period. Average days were categorized with 1060 patients (90.0%) classified as on time, 108 (9.2%) were late, and 10 (0.8%) were very late. For max days between visits, 197 patients (16.7%) were on time, 773 (65.6%) were late, and 208 (17.7%) were very late. After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = -5.9) groups saw fewer letters in both the avg and max days categories than patients in the on-time group (P < .001).
Conclusions and Relevance


These results provide evidence to support the concept that visit adherence contributes to VA outcomes in neovascular age-related macular degeneration. The magnitude of the association of visit adherence with VA outcomes in this clinical scenario suggests that substantial effort should be expended to strive for visit adherence or therapeutic strategies that reduce the visit burden without compromising VA outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT00593450.",2020,"After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = ","['1178 patients', 'individuals with neovascular age-related macular degeneration', 'the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women', 'individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics', 'Patients With Neovascular Age-Related Macular Degeneration', 'Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009']",['bevacizumab vs ranibizumab'],"['Visit Adherence and Visual Acuity', 'mean (SD) number of missed visits', 'complete visit constancy', 'visual acuity (VA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.152998,"After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = ","[{'ForeName': 'Meera S', 'Initials': 'MS', 'LastName': 'Ramakrishnan', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Yinxi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Center for Preventative Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'VanderBeek', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.4577']
3650,32135135,Glycaemic status during pregnancy and longitudinal measures of fetal growth in a multi-racial US population: a prospective cohort study.,"BACKGROUND


The timepoint at which fetal growth begins to differ by maternal glycaemic status is not well understood. To address this lack of data, we examined gestational diabetes, impaired glucose tolerance, and early pregnancy glucose concentrations in relation to fetal growth trajectories.
METHODS


This cohort study included 2458 pregnant women from the NICHD Fetal Growth Studies-Singletons study, which took place between 2009 and 2013. Women were recruited from 12 clinical centres in the USA. Women aged 18-40 years without major chronic conditions when entering pregnancy were included and those with records of neither glucose screening test or glucose tolerance test were excluded from the study. Women were enrolled at gestational weeks 8-13 and randomly assigned to four ultrasonogram schedules (Group A; weeks 16, 24, 30, 34; Group B: weeks 18, 26, 31, 35, 39; Group C: weeks 20, 28, 32, 36; Group D: weeks 22, 29, 33, 37, 41) to capture weekly fetal growth. Gestational diabetes, impaired glucose tolerance, and normal glucose tolerance were defined by medical record review. Glucose was measured in a subsample of women at weeks 10-14. We modelled fetal growth trajectories using linear mixed models with cubic splines. This study is registered with ClinicalTrials.gov, NCT00912132.
FINDINGS


Of the 2458 women included in this study, 107 (4·4%) had gestational diabetes, 118 (4·8%) had impaired glucose tolerance, and 2020 (82·2%) had NGT. 213 women were excluded from the main analysis. The cohort with gestational diabetes was associated with a larger estimated fetal weight that started at week 20 and was significant at week 28-40 (at week 37: 3061 g [95% CI 2967-3164] for women with gestational diabetes vs 2943 g [2924-2962] for women with normal glucose tolerance, adjusted p=0·02). In addition, glucose levels at weeks 10-14 were positively associated with estimated fetal weight starting at week 23 and the association became significant at week 27 (at week 37: 3073 g [2983-3167] in the highest tertile vs 2853 g [2755-2955] in the lowest tertile, adjusted p=0·0009.
INTERPRETATION


Gestational diabetes was associated with a larger fetal size that started at week 20 and became significant at gestational week 28. Efforts to mitigate gestational diabetes-related fetal overgrowth should start before 24-28 gestational weeks, when gestational diabetes is typically screened for in the USA.
FUNDING


National Institutes of Health.",2020,The cohort with gestational diabetes was associated with a larger estimated fetal weight that started at week 20 and was significant at week 28-40 (at week 37: 3061,"['Women were enrolled at gestational weeks 8-13', 'women with gestational diabetes vs 2943 g', '2458 women included in this study, 107 (4·4%) had gestational diabetes, 118 (4·8%) had impaired glucose tolerance, and 2020 (82·2%) had NGT', '2924-2962] for women with normal glucose tolerance, adjusted p=0·02', 'Women aged 18-40 years without major chronic conditions when entering pregnancy were included and those with records of neither glucose screening test or glucose tolerance test were excluded from the study', '213 women were excluded from the main analysis', '2458 pregnant women from the NICHD Fetal Growth Studies-Singletons study, which took place between 2009 and 2013', 'Women were recruited from 12 clinical centres in the USA']",[],"['glucose levels', 'Glucose', 'estimated fetal weight starting', 'Gestational diabetes, impaired glucose tolerance, and normal glucose tolerance', 'Glycaemic status']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2355580', 'cui_str': 'Record of (contextual qualifier) (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0017741', 'cui_str': 'Glucose tolerance test (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",2458.0,0.105319,The cohort with gestational diabetes was associated with a larger estimated fetal weight that started at week 20 and was significant at week 28-40 (at week 37: 3061,"[{'ForeName': 'Mengying', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Stefanie N', 'Initials': 'SN', 'LastName': 'Hinkle', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sungduk', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jagteshwar', 'Initials': 'J', 'LastName': 'Grewal', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Skupski', 'Affiliation': 'Department of Obstetrics and Gynecology, New York-Presbyterian Hospital Queens, Flushing, NY, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Newman', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island, Providence, RI, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sciscione', 'Affiliation': 'Christiana Care Health System, Newark, DE, USA.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Zork', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Wing', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics-Gynecology, University of California School of Medicine, Irvine, CA, USA; Fountain Valley Regional Hospital and Medical Center, Fountain Valley, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nageotte', 'Affiliation': 'Long Beach Memorial Medical Center, Long Beach, CA, USA.'}, {'ForeName': 'Fasil', 'Initials': 'F', 'LastName': 'Tekola-Ayele', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Germaine M Buck', 'Initials': 'GMB', 'LastName': 'Louis', 'Affiliation': 'College of Health and Human Services, George Mason University, VA, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Albert', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Cuilin', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. Electronic address: zhangcu@mail.nih.gov.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30024-3']
3651,31999297,Characteristics of Eyes With Good Visual Acuity at 5 Years After Initiation of Treatment for Age-Related Macular Degeneration but Not Receiving Treatment From Years 3 to 5: Post Hoc Analysis of the CATT Randomized Clinical Trial.,"Importance


Identifying the characteristics of eyes with neovascular age-related macular degeneration (nAMD) that maintain good vision without anti-vascular endothelial growth factor treatment for at least 3 years after management, as occurred in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT), may have prognostic importance and help in understanding the disease and its treatment.
Objectives


To ascertain the characteristics of eyes in the CATT that retained good vision despite receiving no therapy for 3 years after release from the 2-year CATT treatment protocol.
Design, Setting and Participants


This case-control study analyzed the baseline and follow-up characteristics of eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009. After initial randomization to 1 of 4 treatment groups (ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, or bevacizumab as needed), at year 1, participants in the monthly groups were rerandomized to continue monthly treatment or to switch to as-needed treatment using the same drug as originally assigned. At year 2, participants were released from the protocol to treatment at the discretion of their ophthalmologist. At year 5, participants were recalled for examination. This present analysis, conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group).
Main Outcomes and Measures


Visual acuity, morphologic characteristics, and number of treatments over 5 years.
Results


Among 625 eyes with nAMD at baseline and a visual acuity measurement at year 5, 40 (6.4%; 95% CI, 4.7%-8.7%) were included in the analysis. These 40 participants, compared with the other group (n = 585), had a lower mean (SD) age of 74.7 (7.3) years (vs 77.7 [7.3] years; P = .01) and included 26 women (65.0%). Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02). Eyes in the CTGVA group with as-needed treatment received fewer mean (SD) injections in year 1 (5.8 [4.0] vs 8.1 [3.5]) and year 2 (7.7 [5.7] vs 13.8 [6.8]) than eyes in the other as-needed group. Mean (SD) visual acuity letter score at 5 years was 79.0 (5.5; Snellen 20/25) in the CTGVA group and 57.5 (24.2; Snellen 20/80) in the other group.
Conclusions and Relevance


These findings suggest that a small proportion of eyes with nAMD can retain good visual acuity with no treatment for at least 3 years after the initial 2 years of treatment. Unique characteristics of eyes that could discontinue treatment while maintaining good visual acuity could not be identified at baseline, but data suggest that not all eyes with this disease may need treatment forever.
Trial Registration


ClinicalTrials.gov Identifier: NCT00593450.",2020,"Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02).","['625 eyes with nAMD at baseline and a', 'eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009', 'Eyes With Good Visual Acuity at 5 Years', 'conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group', 'eyes with neovascular age-related macular degeneration (nAMD']","['ranibizumab monthly, bevacizumab monthly, ranibizumab', 'CTGVA']","['visual acuity', 'good visual acuity', 'visual acuity letter score', 'Measures\n\n\nVisual acuity, morphologic characteristics, and number of treatments over 5 years', 'fellow eye', 'visual acuity measurement', 'Mean (SD) visual acuity letter score']","[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0871549', 'cui_str': 'Cessation of Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",26.0,0.215636,"Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02).","[{'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Scoles', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Hua', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Grunwald', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Toth', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, The Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5831']
3652,32160897,The effect of counseling with a skills training approach on maternal functioning: a randomized controlled clinical trial.,"BACKGROUND


The role of the mother can be deeply satisfying, but it is associated with many challenges including challenges during the postpartum period that may impede the optimal development of the infant. Therefore, the aim of the present study was to investigate the effects of counseling using the Skills Training Approach (STA) on postpartum maternal functioning.
METHODS


This randomized controlled trial was performed on 68 postpartum women who referred to health centers of Tabriz-Iran in 2019. Participants were assigned to one of two groups - either counseling or control through the block randomization method. The intervention group received four counseling sessions using the Skills Training Approach (STA). Before and two weeks after the completion of the intervention, the Barkin Index of Maternal Functionning (BIMF) was completed by the participants. The independent t-test and ANCOVA (Analysis of Covariance) was used to analyze the data.
RESULTS


There was no statistically significant difference between the two groups in terms of sociodemographic characteristics and the baseline scores of the BIMF and its domains (p > 0.05). Before the intervention, the mean (SD) total score of the BIMF in the intervention group was 73.1 (8.5) and in the control group, it was 71.6 (4.8). Post-intervention, the mean (SD) of the total score of the BIMF in the intervention group was 95.8 (11.8) and in the control group, it was 70.3 (4.5). Based on the ANCOVA test and after adjusting the baseline score, the mean total score of the BIMF was significantly higher in the intervention group than in the control group (Mean Difference (MD): 22.9; 95% CI: 18.2 to 27.6; p < 0.001). The post-intervention scores of all domains of the BIMF including self-care (MD: 3.8), infant care (MD: 2.0), mother-child interaction (MD: 4.8), psychological wellbeing (MD: 8.4), social support (MD: 4.0), management (MD: 6.8), and adjustment to new motherhood (MD: 3.2) were significantly higher in the intervention group compared to the control group (P < 0.001).
CONCLUSION


In this study, counseling, using STA, was effective in improving maternal functioning in all of the domains. This intervention, aimed at skill-building, should be strongly considered where improved postpartum functioning is the goal.
TRIAL REGISTRATION


IRCT20120718010324N49. Registered 18 January 2019.",2020,There was no statistically significant difference between the two groups in terms of sociodemographic characteristics and the baseline scores of the BIMF and its domains (p > 0.05).,['68 postpartum women who referred to health centers of Tabriz-Iran in 2019'],"['counseling with a skills training approach', 'counseling sessions using the Skills Training Approach (STA', 'counseling using the Skills Training Approach (STA']","['BIMF including self-care (MD: 3.8), infant care (MD: 2.0), mother-child interaction (MD: 4.8), psychological wellbeing (MD: 8.4), social support (MD: 4.0), management (MD: 6.8), and adjustment to new motherhood (MD: 3.2', 'mean total score of the BIMF', 'mean (SD) total score of the BIMF', 'Barkin Index of Maternal Functionning (BIMF', 'mean (SD) of the total score of the BIMF', 'sociodemographic characteristics and the baseline scores of the BIMF and its domains', 'maternal functioning']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1529286', 'cui_str': 'stas'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0021272', 'cui_str': 'Infant Care'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0037438'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0337490', 'cui_str': 'Motherhood (observable entity)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",68.0,0.057036,There was no statistically significant difference between the two groups in terms of sociodemographic characteristics and the baseline scores of the BIMF and its domains (p > 0.05).,"[{'ForeName': 'Fatemeh Karami', 'Initials': 'FK', 'LastName': 'Chamgurdani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Barkin', 'Affiliation': 'Department of Community Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Esmaeilpour', 'Affiliation': 'Faculty of Education and Psychology, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Malakouti', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Buoli', 'Affiliation': 'Department of Psychiatry, 5University of Milan, Milan, Italy.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvandm@tbzmed.ac.ir.'}]",BMC women's health,['10.1186/s12905-020-00914-w']
3653,31917441,Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease: A Randomized Clinical Trial.,"Importance


Although the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) reported herein and the Treat and Extend study provided data to show noninferiority of treat-and-extend (T&E) at 12 months, to date there are few data on 24-month T&E trials compared with monthly dosing.
Objective


To compare the efficacy of ranibizumab using a T&E regimen to monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months.
Design, Setting, and Participants


A randomized, open-label, multicenter, noninferiority intention-to-treat trial with a margin of -5 letters in best-corrected visual acuity (BCVA) from baseline to 12 months between groups was conducted at 27 treatment centers in Canada. Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD. The study was conducted from May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018.
Interventions


Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab, 0.5 mg, in either a T&E or monthly dosing regimen.
Main Outcomes and Measures


Mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24.
Results


Of the 580 randomized patients, 350 were women (60.3%) and 547 were white (94.3%). Mean (SD) age was 78.8 (7.8) years. By the end of month 24, 466 of the 580 randomized patients (80.3%) had completed the study and participants in the T&E arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over 2 years (95% CI, 5.4-6.5; P < .001). The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21). There was a gain of 15 or more letters in 25.5% of the T&E group and 23.1% of the monthly treatment group (difference, 2.4%; 95% CI, -6.8% to 11.6%; P = .59) and a loss of 15 or more letters in 6.5% of the T&E group and 5.8% of the monthly treatment group (difference, -0.7%; 95% CI, -9.9% to 8.5%; P = .85).
Conclusions and Relevance


These findings suggest that change in vision from baseline is not worse with a T&E compared with a monthly regimen of ranibizumab for nAMD through 24 months, achieving clinically meaningful improvements in BCVA despite fewer injections and visits.
Trial Registration


ClinicalTrials.gov identifier: NCT02103738.",2020,"The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21).","['580 randomized patients', 'Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD', 'treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months', '350 were women (60.3%) and 547 were white (94.3', 'Mean (SD) age was 78.8 (7.8) years', 'Patients With Neovascular Age-Related Macular Disease (CANTREAT', 'Patients With Neovascular Age-Related Macular Disease', 'Interventions\n\n\nPatients with nAMD', 'May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018']","['T&E or monthly dosing regimen', 'ranibizumab', 'Ranibizumab', 'Treat-and-Extend Regimen With Ranibizumab', 'intravitreal ranibizumab']","['gain of 15 or more letters', 'mean (SD) BCVA improvement']","[{'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",580.0,0.338271,"The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kertes', 'Affiliation': 'The John and Liz Tory Eye Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ivan J', 'Initials': 'IJ', 'LastName': 'Galic', 'Affiliation': 'Montreal Retina Institute, Montreal, Québec, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Greve', 'Affiliation': 'Alberta Retina Consultants, Edmonton, Alberta, Canada.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'Calgary Retina Consultants, Calgary, Alberta, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, Québec, Canada.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Lahaie', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, Québec, Canada.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Sheidow', 'Affiliation': 'Ivey Eye Institute, London, Ontario, Canada.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5540']
3654,32164678,Let's CHAT (community health approaches to) dementia in Aboriginal and Torres Strait Islander communities: protocol for a stepped wedge cluster randomised controlled trial.,"BACKGROUND


Documented rates of dementia and cognitive impairment not dementia (CIND) in older Aboriginal and Torres Strait Islander Peoples is 3-5 times higher than the rest of the population, and current evidence suggests this condition is under-diagnosed and under-managed in a clinical primary care setting. This study aims to implement and evaluate a culturally responsive best practice model of care to optimise the detection and management of people with cognitive impairment and/or dementia, and to improve the quality of life of carers and older Aboriginal and Torres Islander Peoples with cognitive impairment.
METHODS/DESIGN


The prospective study will use a stepped-wedge cluster randomised controlled trial design working with 12 Aboriginal Community Controlled Health Services (ACCHSs) across four states of Australia. Utilising a co-design approach, health system adaptations will be implemented including (i) development of a best practice guide for cognitive impairment and dementia in Aboriginal and Torres Strait Islander communities (ii) education programs for health professionals supported by local champions and (iii) development of decision support systems for local medical software. In addition, the study will utilise a knowledge translation framework, the Integrated Promoting Action on Research Implementation in Health Services (iPARIHS) Framework, to promote long-term sustainable practice change. Process evaluation will also be undertaken to measure the quality, fidelity and contextual influences on the outcomes of the implementation. The primary outcome measures will be rates of documentation of dementia and CIND, and evidence of improved management of dementia and CIND among older Indigenous peoples attending Aboriginal and Torres Strait Islander primary care services through health system changes. The secondary outcomes will be improvements to the quality of life of older Indigenous peoples with dementia and CIND, as well as that of their carers and families.
DISCUSSION


The Let's CHAT Dementia project will co-design, implement and evaluate a culturally responsive best practice model of care embedded within current Indigenous primary health care. The best practice model of care has the potential to optimise the timely detection (especially in the early stages) and improve the ongoing management of people with dementia or cognitive impairment.
TRIAL REGISTRATION


ACTRN12618001485224. Date of registration: 04 of September 2019.",2020,"The secondary outcomes will be improvements to the quality of life of older Indigenous peoples with dementia and CIND, as well as that of their carers and families.
","['people with dementia or cognitive impairment', 'people with cognitive impairment and/or dementia', '12 Aboriginal Community Controlled Health Services (ACCHSs) across four states of Australia']",[],"['rates of documentation of dementia and CIND, and evidence of improved management of dementia and CIND among older Indigenous peoples attending Aboriginal and Torres Strait Islander primary care services through health system changes', 'quality of life of older Indigenous peoples with dementia and CIND, as well as that of their carers and families']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",,0.100254,"The secondary outcomes will be improvements to the quality of life of older Indigenous peoples with dementia and CIND, as well as that of their carers and families.
","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bradley', 'Affiliation': 'The University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Royal Melbourne Hospital, Royal Park Campus, Administration Building 21, 34 -54 Poplar Road, Melbourne, Victoria, 3052, Australia. kate.bradley@unimelb.edu.au.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'The University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Royal Melbourne Hospital, Royal Park Campus, Administration Building 21, 34 -54 Poplar Road, Melbourne, Victoria, 3052, Australia.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Hughson', 'Affiliation': 'The University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Royal Melbourne Hospital, Royal Park Campus, Administration Building 21, 34 -54 Poplar Road, Melbourne, Victoria, 3052, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Atkinson', 'Affiliation': 'The University of Western Australia, Rural Clinical School of Western Australia , PO Box 1377, Broome, 6725, Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Bessarab', 'Affiliation': 'The University of Western Australia, M303, 35 Stirling Highway, Perth, 6009, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'The University of Western Australia, Rural Clinical School of Western Australia , PO Box 1377, Broome, 6725, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Radford', 'Affiliation': 'Neuroscience Research Australia, 139 Barker Street, Sydney, NSW, 2031, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'University of Western Australia, 35 Stirling Highway, Perth, 6009, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Strivens', 'Affiliation': 'Queensland Government, Brisbane, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'The University of Western Australia, 167 Fitzgerald St, Geraldton, WA, 6530, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Blackberry', 'Affiliation': 'LaTrobe University, PO box 821, Wodonga, VIC, 3689, Australia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'LoGiudice', 'Affiliation': 'The University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Royal Melbourne Hospital, Royal Park Campus, Administration Building 21, 34 -54 Poplar Road, Melbourne, Victoria, 3052, Australia.'}]",BMC health services research,['10.1186/s12913-020-4985-1']
3655,31978933,"Detection of acute 3,4-methylenedioxymethamphetamine (MDMA) effects across protocols using automated natural language processing.","The detection of changes in mental states such as those caused by psychoactive drugs relies on clinical assessments that are inherently subjective. Automated speech analysis may represent a novel method to detect objective markers, which could help improve the characterization of these mental states. In this study, we employed computer-extracted speech features from multiple domains (acoustic, semantic, and psycholinguistic) to assess mental states after controlled administration of 3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin. The training/validation set comprised within-participants data from 31 healthy adults who, over four sessions, were administered MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo in randomized, double-blind fashion. Participants completed two 5-min speech tasks during peak drug effects. Analyses included group-level comparisons of drug conditions and estimation of classification at the individual level within this dataset and on two independent datasets. Promising classification results were obtained to detect drug conditions, achieving cross-validated accuracies of up to 87% in training/validation and 92% in the independent datasets, suggesting that the detected patterns of speech variability are associated with drug consumption. Specifically, we found that oxytocin seems to be mostly driven by changes in emotion and prosody, which are mainly captured by acoustic features. In contrast, mental states driven by MDMA consumption appear to manifest in multiple domains of speech. Furthermore, we find that the experimental task has an effect on the speech response within these mental states, which can be attributed to presence or absence of an interaction with another individual. These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.",2020,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"['31 healthy adults who, over four sessions, were administered']","['placebo', 'MDMA', '3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin', 'oxytocin']",[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],31.0,0.130727,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Agurto', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Cecchi', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA. gcecchi@us.ibm.com.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Norel', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ostrand', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Baggott', 'Affiliation': 'Addiction and Pharmacology Research Laboratory, Friends Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet de', 'Initials': 'H', 'LastName': 'Wit', 'Affiliation': 'Human Behavioral Pharmacology Laboratory, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Centre for Youth Mental Health, University of Melbourne, and Orygen National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0620-4']
3656,31810865,Biomarker-guided antibiotic stewardship in suspected ventilator-associated pneumonia (VAPrapid2): a randomised controlled trial and process evaluation.,"BACKGROUND


Ventilator-associated pneumonia is the most common intensive care unit (ICU)-acquired infection, yet accurate diagnosis remains difficult, leading to overuse of antibiotics. Low concentrations of IL-1β and IL-8 in bronchoalveolar lavage fluid have been validated as effective markers for exclusion of ventilator-associated pneumonia. The VAPrapid2 trial aimed to determine whether measurement of bronchoalveolar lavage fluid IL-1β and IL-8 could effectively and safely improve antibiotic stewardship in patients with clinically suspected ventilator-associated pneumonia.
METHODS


VAPrapid2 was a multicentre, randomised controlled trial in patients admitted to 24 ICUs from 17 National Health Service hospital trusts across England, Scotland, and Northern Ireland. Patients were screened for eligibility and included if they were 18 years or older, intubated and mechanically ventilated for at least 48 h, and had suspected ventilator-associated pneumonia. Patients were randomly assigned (1:1) to biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit. Patients were randomised using randomly permuted blocks of size four and six and stratified by site, with allocation concealment. Clinicians were masked to patient assignment for an initial period until biomarker results were reported. Bronchoalveolar lavage was done in all patients, with concentrations of IL-1β and IL-8 rapidly determined in bronchoalveolar lavage fluid from patients randomised to the biomarker-based antibiotic recommendation group. If concentrations were below a previously validated cutoff, clinicians were advised that ventilator-associated pneumonia was unlikely and to consider discontinuing antibiotics. Patients in the routine use of antibiotics group received antibiotics according to usual practice at sites. Microbiology was done on bronchoalveolar lavage fluid from all patients and ventilator-associated pneumonia was confirmed by at least 10 4  colony forming units per mL of bronchoalveolar lavage fluid. The primary outcome was the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage. Data were analysed on an intention-to-treat basis, with an additional per-protocol analysis that excluded patients randomly assigned to the intervention group who defaulted to routine use of antibiotics because of failure to return an adequate biomarker result. An embedded process evaluation assessed factors influencing trial adoption, recruitment, and decision making. This study is registered with ISRCTN, ISRCTN65937227, and ClinicalTrials.gov, NCT01972425.
FINDINGS


Between Nov 6, 2013, and Sept 13, 2016, 360 patients were screened for inclusion in the study. 146 patients were ineligible, leaving 214 who were recruited to the study. Four patients were excluded before randomisation, meaning that 210 patients were randomly assigned to biomarker-guided recommendation on antibiotics (n=104) or routine use of antibiotics (n=106). One patient in the biomarker-guided recommendation group was withdrawn by the clinical team before bronchoscopy and so was excluded from the intention-to-treat analysis. We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58). Bronchoalveolar lavage was associated with a small and transient increase in oxygen requirements. Established prescribing practices, reluctance for bronchoalveolar lavage, and dependence on a chain of trial-related procedures emerged as factors that impaired trial processes.
INTERPRETATION


Antibiotic use remains high in patients with suspected ventilator-associated pneumonia. Antibiotic stewardship was not improved by a rapid, highly sensitive rule-out test. Prescribing culture, rather than poor test performance, might explain this absence of effect.
FUNDING


UK Department of Health and the Wellcome Trust.",2020,We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58).,"['patients admitted to 24 ICUs from 17 National Health Service hospital trusts across England, Scotland, and Northern Ireland', 'patients with suspected ventilator-associated pneumonia', 'Patients were screened for eligibility and included if they were 18 years or older, intubated and mechanically ventilated for at least 48 h, and had suspected ventilator-associated pneumonia', 'Between Nov 6, 2013, and Sept 13, 2016, 360 patients were screened for inclusion in the study', 'suspected ventilator-associated pneumonia (VAPrapid2', 'Four patients were excluded before randomisation, meaning that 210 patients', '146 patients were ineligible, leaving 214 who were recruited to the study', 'patients with clinically suspected ventilator-associated pneumonia']","['biomarker-guided recommendation on antibiotics (intervention group) or routine use of antibiotics (control group) using a web-based randomisation service hosted by Newcastle Clinical Trials Unit', 'biomarker-guided recommendation on antibiotics (n=104) or routine use of antibiotics', 'Biomarker-guided antibiotic stewardship']","['oxygen requirements', 'distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage', 'Antibiotic stewardship']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}, {'cui': 'C4505100', 'cui_str': 'Antibiotic Stewardship'}]",146.0,0.342377,We found no significant difference in the primary outcome of the distribution of antibiotic-free days in the 7 days following bronchoalveolar lavage in the intention-to-treat analysis (p=0·58).,"[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Hellyer', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK; Regional Intensive Care Unit, The Royal Hospitals, Belfast, UK.""}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Walsh', 'Affiliation': ""Anaesthesia, Critical Care and Pain Medicine, University of Edinburgh, Queen's Medical Research Institute, Edinburgh, UK; Intensive Care Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Conway Morris', 'Affiliation': ""Division of Anaesthesia, Department of Medicine, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Suveer', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Cancer and Surgery, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dark', 'Affiliation': 'Division of Infection Immunity and Respiratory Medicine, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Alistair I', 'Initials': 'AI', 'LastName': 'Roy', 'Affiliation': 'Integrated Critical Care Unit, Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK; Intensive Care Unit, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'McMullan', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Emerson', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Integrated Critical Care Unit, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Kallirroi', 'Initials': 'K', 'LastName': 'Kefala', 'Affiliation': 'Intensive Care Unit, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': ""O'Kane"", 'Affiliation': ""The Wellcome-Wolfson Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Simon V', 'Initials': 'SV', 'LastName': 'Baudouin', 'Affiliation': 'Intensive Care Unit, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.'}, {'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Paterson', 'Affiliation': 'Intensive Care Unit, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rostron', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK; Integrated Critical Care Unit, Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bannard-Smith', 'Affiliation': 'Intensive Care Unit, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Robin', 'Affiliation': 'Intensive Care Unit, Countess of Chester NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Ingeborg D', 'Initials': 'ID', 'LastName': 'Welters', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bassford', 'Affiliation': 'Intensive Care Unit, University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Yates', 'Affiliation': 'Intensive Care Unit, Northumbria Specialist Emergency Care Hospital, Cramlington, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Spencer', 'Affiliation': 'Intensive Care Unit, Preston Royal Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Shondipon K', 'Initials': 'SK', 'LastName': 'Laha', 'Affiliation': 'Intensive Care Unit, Preston Royal Hospital, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hulme', 'Affiliation': 'Intensive Care Unit, Sandwell General Hospital, Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bonner', 'Affiliation': 'Intensive Care Unit, James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Linnett', 'Affiliation': 'Intensive Care Unit, Queen Elizabeth Hospital, Gateshead NHS Foundation Trust, Gateshead, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sonksen', 'Affiliation': 'Intensive Care Unit, Russells Hall Hospital, Dudley Group NHS Foundation Trust, Dudley, UK.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Van Den Broeck', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Boschman', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Dw James', 'Initials': 'DJ', 'LastName': 'Keenan', 'Affiliation': 'Becton Dickinson Biosciences Europe, Erembodegem, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'A Joy', 'Initials': 'AJ', 'LastName': 'Allen', 'Affiliation': 'National Institute for Health Research Newcastle In Vitro Diagnostics Cooperative, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Phair', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Bowett', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Simpson', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK; National Institute for Health Research Newcastle In Vitro Diagnostics Cooperative, Newcastle University, Newcastle, UK. Electronic address: j.simpson@ncl.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30367-4']
3657,31525441,"A regimen to minimize pain during blue light photodynamic therapy of actinic keratoses: Bilaterally controlled, randomized trial of simultaneous versus conventional illumination.","BACKGROUND


Blue light photodynamic therapy (PDT) is effective for actinic keratosis, but many patients experience stinging pain during illumination.
OBJECTIVE


To compare a conventional regimen (1 hour of 5-aminolevulinic acid [ALA] preincubation, followed by blue light) versus a new modified regimen in which blue light is started immediately after ALA application.
METHODS


A clinical trial with a bilaterally controlled, intrapatient study design was conducted with 23 patients. Topical 20% ALA was applied to the entire face and/or scalp. On 1 side of the body, blue light was started immediately and continued for either 30, 45, or 60 minutes (simultaneous PDT). On the contralateral side, the blue light began 1 hour after ALA application and lasted 1000 seconds (conventional PDT). Pain was evaluated on a scale from 0 to 10. Actinic keratosis lesion counts were determined by clinical examination and photography.
RESULTS


All patients experienced significantly less pain during simultaneous illumination than during the conventional regimen. At 3 months after treatment, lesion clearance was nearly identical on the 2 sides, as determined by statistical testing of noninferiority ± 15% margin.
LIMITATIONS


Although bilaterally controlled, the study was relatively small. Additional studies are recommended.
CONCLUSION


The modified PDT regimen is essentially painless, yet it provides treatment efficacy similar to a conventional regimen.",2020,"At 3 months post-treatment, lesion clearance was nearly identical on the two sides, as determined by statistical testing of non-inferiority ± 15% margin.
","['23 patients', 'actinic keratoses']","['conventional regimen (1 h ALA preincubation, followed by blue light', 'Blue light photodynamic therapy (PDT', 'Topical 20% ALA', 'conventional illumination']","['lesion clearance', 'Pain', 'pain', 'AK lesion counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0303896', 'cui_str': 'Blue light (physical force)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1964256', 'cui_str': 'Illumination - action'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",1000.0,0.0120254,"At 3 months post-treatment, lesion clearance was nearly identical on the two sides, as determined by statistical testing of non-inferiority ± 15% margin.
","[{'ForeName': 'Urvashi', 'Initials': 'U', 'LastName': 'Kaw', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Muneeb', 'Initials': 'M', 'LastName': 'Ilyas', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Bullock', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rittwage', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Riha', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vidimos', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Warren', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Maytin', 'Affiliation': 'Department of Dermatology, Cleveland Clinic, Cleveland, Ohio. Electronic address: maytine@ccf.org.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.010']
3658,31542406,"Greater efficacy of SPF 100+ sunscreen compared with SPF 50+ in sunburn prevention during 5 consecutive days of sunlight exposure: A randomized, double-blind clinical trial.","BACKGROUND


Beach vacations are high-risk settings for overexposure to ultraviolet radiation.
OBJECTIVE


To compare the sunburn protective efficacy of SPF 50+ and SPF 100+ sunscreens under actual use at the beach.
METHODS


A prospective, randomized, double-blind, single-center, split-body/face study of 55 healthy individuals. Each participant applied both sunscreens to randomized sides of the face/body for up to 5 consecutive days. Blinded clinical evaluation of erythema by a single grader and objective instrumental assessments, colorimetry, and diffuse reflectance spectroscopy were performed the morning after each sun exposure.
RESULTS


After 5 days, 31 (56%) participants had more sunburn on the SPF 50+ side compared to 4 (7%) on the SPF 100+ side. Overall, mean erythema intensity showed statistically significantly less erythema on the SPF 100+ side compared with the SPF 50+ side. The first observation of sunburn exclusively on the SPF 50+ side occurred after 1 day of sun exposure, whereas that for SPF 100+ occurred after 3 days of sun exposure.
LIMITATIONS


Only initial sunscreen application was monitored, only 1 participant with skin phototype I was recruited, and participants were recruited from a local beach area.
CONCLUSION


SPF 100+ was significantly more effective in protecting against ultraviolet radiation-induced erythema and sunburn than SPF 50+ in actual use in a beach vacation setting.",2020,SPF 100+ was significantly more effective in protecting against UV-induced erythema and sunburn than SPF 50+ in actual use within a beach vacation setting.,"['one skin-phototype I subject was recruited, and subjects were recruited from local beach area', '55 healthy subjects']","['SPF 50+ and SPF 100+ sunscreens', 'SPF 100+ sunscreen']",['mean erythema intensity'],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0331781', 'cui_str': 'Beach (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",55.0,0.182889,SPF 100+ was significantly more effective in protecting against UV-induced erythema and sunburn than SPF 50+ in actual use within a beach vacation setting.,"[{'ForeName': 'Indermeet', 'Initials': 'I', 'LastName': 'Kohli', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Nicholson', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan; Department of Dermatology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Williams', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Lyons', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'InSeok', 'Initials': 'I', 'LastName': 'Seo', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Prithwiraj', 'Initials': 'P', 'LastName': 'Maitra', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Atillasoy', 'Affiliation': 'Johnson & Johnson Consumer Inc, Skillman, New Jersey.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Lim', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Iltefat H', 'Initials': 'IH', 'LastName': 'Hamzavi', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. Electronic address: Ihamzav1@hfhs.org.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.018']
3659,31586600,Efficacy and tolerability of an investigational nitric oxide-releasing topical gel in patients with molluscum contagiosum: A randomized clinical trial.,"BACKGROUND


Although a variety of ablative, topical, and systemic therapies are used for molluscum contagiosum (MC), none has been well studied or approved by the US Food and Drug Administration.
OBJECTIVES


To compare the efficacy and tolerability of topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle.
METHODS


A 12-week, phase 2, multicenter, randomized, double-blind, vehicle-controlled clinical trial of topical SB206.
RESULTS


A total of 256 patients (mean age, approximately 7 years) participated. Of patients who completed 12 weeks of treatment (n = 217), all MC lesions cleared in 20.0% of patients who received vehicle compared with 13.2%, 41.0%, and 35.1% of patients treated with twice daily SB206 4%, 8%, and 12%, respectively, and 41.9% of patients treated with once daily SB206 12%. Application-site erythema occurred in 10.6% of patients treated with SB206. Application-site reactions were the most common adverse events leading to treatment discontinuation, affecting 2 patients (approximately 4%) in each of the SB206 4%, 8%, and 12% twice daily groups and 0 patients in the vehicle or SB206 12% once daily groups.
LIMITATIONS


A larger study is needed to confirm the efficacy of SB206 12% once daily and provide additional safety assessments.
CONCLUSION


Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study.",2020,"Application-site reactions were the most common AEs leading to treatment discontinuation, affecting 2 patients (∼4%) in each of the SB206 4%, 8%, and 12% BID groups and 0 patients in the vehicle or SB206 12% QD groups.
","['Patients With Molluscum Contagiosum', '256 patients ', 'mean age, ∼7 years']","['topical SB206', 'Investigational Nitric Oxide-releasing Topical Gel', 'topical SB206 (berdazimer sodium gel coadministered with hydrogel) with vehicle']","['Application-site erythema', 'MC lesions cleared', 'Efficacy and Tolerability', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026393', 'cui_str': 'Molluscum Contagiosum'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1160728', 'cui_str': 'Topical Gel'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0853700', 'cui_str': 'Application site erythema'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]",256.0,0.211718,"Application-site reactions were the most common AEs leading to treatment discontinuation, affecting 2 patients (∼4%) in each of the SB206 4%, 8%, and 12% BID groups and 0 patients in the vehicle or SB206 12% QD groups.
","[{'ForeName': 'Adelaide A', 'Initials': 'AA', 'LastName': 'Hebert', 'Affiliation': 'UTHealth McGovern Medical School, Houston, Texas.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': 'Saint Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Durham', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'de León', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Reams', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Messersmith', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Maeda-Chubachi', 'Affiliation': 'Novan, Inc, Morrisville, North Carolina. Electronic address: tmaeda-chubachi@novan.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.064']
3660,31558480,Randomized Phase II Trial and Tumor Mutational Spectrum Analysis from Cabozantinib versus Chemotherapy in Metastatic Uveal Melanoma (Alliance A091201).,"PURPOSE


The surface receptor MET is highly expressed on primary uveal melanoma; MET inhibitors demonstrated early clinical signals of efficacy in slowing uveal melanoma growth. The primary objective of our study was to compare the progression-free survival rate at 4 months (PFS4) of patients with uveal melanoma treated with cabozantinib or chemotherapy.
PATIENTS AND METHODS


Patients with metastatic uveal melanoma and RECIST measurable disease were randomized 2:1 to receive either cabozantinib (arm 1) versus temozolomide or dacarbazine (arm 2) with restaging imaging every two cycles. Cross-over from arm 2 to cabozantinib after progression was allowed (arm 2X). Available tumor specimens were analyzed by whole-exome sequencing (WES) and results were correlated with outcome.
RESULTS


Forty-six eligible patients were accrued with 31, 15, and 9 in arms 1, 2, and 2X, respectively. Median lines of prior therapy, including hepatic embolization, were two. Rates of PFS4 in arm 1 and arm 2 were 32.3% and 26.7% ( P  = 0.35), respectively, with median PFS time of 60 and 59 days ( P  = 0.964; HR = 0.99). Median overall survival (OS) was 6.4 months and 7.3 months ( P  = 0.580; HR = 1.21), respectively. Grade 3-4 Common Terminology Criteria for Adverse Events were present in 61.3%, 46.7%, and 37.5% in arms 1, 2, and 2X, respectively. WES demonstrated a mean tumor mutational burden of 1.53 mutations/Mb and did not separate OS ≤ or >1 year ( P  = 0.14). Known mutations were identified by WES and novel mutations were nominated.
CONCLUSIONS


MET/VEGFR blockade with cabozantinib demonstrated no improvement in PFS but an increase in toxicity relative to temozolomide/dacarbazine in metastatic uveal melanoma.",2020,"Median overall survival was 6.4 months and 7.3 months (p=0.580; HR=1.21), respectively.","['Forty-six eligible patients', 'patients with UM treated with cabozantinib or chemotherapy', 'metastatic uveal melanoma (Alliance A091201', 'Patients with metastatic UM and RECIST measurable disease']","['temozolomide/dacarbazine', 'cabozantinib versus chemotherapy', 'cabozantinib', 'temozolomide or dacarbazine']","['CTCAE adverse events', 'Rates of PFS4', 'mean tumor mutational burden', 'median PFS time', 'Median overall survival', 'PFS', 'progression-free survival rate', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0220633', 'cui_str': 'Uveal melanoma'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",46.0,0.163087,"Median overall survival was 6.4 months and 7.3 months (p=0.580; HR=1.21), respectively.","[{'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. lukejj@upmc.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Olson', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Jacob B', 'Initials': 'JB', 'LastName': 'Allred', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Strand', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Riyue', 'Initials': 'R', 'LastName': 'Bao', 'Affiliation': 'Center for Research Informatics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zha', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Carll', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Labadie', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'Bastos', 'Affiliation': 'Miami Cancer Institute-Baptist Health South Florida, Miami, Florida.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Butler', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hogg', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Munster', 'Affiliation': 'University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Herbert Irving Comprehensive Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1223']
3661,32150232,Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial.,"Importance


Although an estimated 30 million people meet criteria for alcohol use disorder (AUD), few receive appropriate pharmacotherapy. A more personalized, symptom-specific, approach might improve efficacy and acceptance.
Objective


To examine whether gabapentin would be useful in the treatment of AUD, especially in those with the most alcohol withdrawal symptoms.
Design, Setting, and Participants


This double-blind randomized clinical trial conducted between November 2014 and June 2018 evaluated gabapentin vs placebo in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period. A total of 145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria were randomized to treatment after 3 abstinent days. Daily drinking was recorded, and percentage of disialo carbohydrate-deficient transferrin in the blood, a heavy drinking marker, was collected at baseline and monthly during treatment.
Interventions


Gabapentin up to 1200 mg/d, orally, vs placebo along with 9 medical management visits (20 minutes each).
Main Outcomes and Measures


The percentage of individuals with no heavy drinking days and those with total abstinence were compared between treatment groups and further evaluated based on prestudy alcohol withdrawal symptoms.
Results


Of 96 randomized individuals, 90 were evaluable (44 in the gabapentin arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94%). The evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2). The prestudy high-alcohol withdrawal group had positive gabapentin effects on no heavy drinking days (P < .02; NNT, 3.1) and total abstinence (P = .003; NNT, 2.7) compared with placebo, while within the low-alcohol withdrawal group, there were no significant differences. These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only. Gabapentin caused more dizziness, but this did not affect efficacy.
Conclusions and Relevance


These data, combined with others, suggest gabapentin might be most efficacious in people with AUD and a history of alcohol withdrawal symptoms. Future studies should evaluate sleep changes and mood during early recovery as mediators of gabapentin efficacy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02349477.",2020,"These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only.","['in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period', '145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria', 'Patients With Alcohol Withdrawal Symptoms', 'arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94', 'evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition', 'people with AUD and a history of alcohol withdrawal symptoms', '96 randomized individuals']","['gabapentin', 'Gabapentin', 'placebo', 'gabapentin vs placebo']","['percentage of individuals with no heavy drinking days and those with total abstinence', 'heavy drinking days', 'dizziness', 'total abstinence', 'prestudy alcohol withdrawal symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",,0.35725,"These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only.","[{'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Latham', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Voronin', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Book', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bristol', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0249']
3662,32122322,Effect of a tailored leaflet to promote diabetic retinopathy screening among young adults with type 2 diabetes: a randomised controlled trial.,"BACKGROUND


Young adults with type 2 diabetes (aged 18-39 years) are at risk of early onset and rapid progression of diabetic retinopathy, the leading cause of blindness and vision loss in working age adults. Early detection via retinal screening can prevent most vision loss, yet screening rates are consistently lower among this priority population than the general diabetes population. We aimed to test the effect of a tailored, evidence-based brief health behaviour change intervention (leaflet) on self-reported screening uptake, and previously identified social cognitive determinants of retinal screening.
METHODS


A pragmatic, two-arm randomised controlled trial was conducted from September 2014 to April 2015. Participants were stratified by prior screening uptake (Yes/No) and randomly allocated to intervention (leaflet) or 'usual care' control (no leaflet). Primary outcome was self-reported screening uptake four weeks post-intervention for 'No' participants who had not previously screened for diabetic retinopathy. Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour. To assess intervention effects on secondary outcome variables, we conducted independent samples t-tests (two-tailed) on pre-post change scores.
RESULTS


129 young adults (26% no prior retinal screen) completed baseline; 101 completed post-intervention. Power to determine effect on the primary outcome was curtailed by low recruitment of individuals with no prior retinal screen and loss to follow-up. Attrition was associated significantly with country of birth, language spoken at home, and marital status. Significant intervention effect was observed for one secondary outcome variable: knowledge of diabetic retinopathy (p = .03) with moderate effect (partial eta squared η 2  = .05); no adverse effects were reported. Control group participants received the leaflet at study completion.
CONCLUSIONS


This study confirms that a well-designed eye health and retinal screening promotion leaflet can increase knowledge of diabetic retinopathy, an important screening predictor. The study highlights the challenges of conducting 'real-world' health behaviour change research with this priority population, providing insights for clinicians and researchers. Strategies to recruit, engage and retain hard-to-reach populations are discussed including nonconventional alternatives to randomised controlled trial designs.
TRIAL REGISTRATION


ACTRN12614001110673, UTN No.: U1111-1161-9803. Registered 20 October 2014 - retrospectively registered https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127.",2020,"Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour.","['Registered 20 October 2014 - retrospectively registered https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127', 'young adults with type 2 diabetes', 'September 2014 to April 2015', 'Young adults with type 2 diabetes (aged 18-39\u2009years', '129 young adults (26% no prior retinal screen) completed baseline; 101 completed post-intervention']","['tailored leaflet to promote diabetic retinopathy screening', 'tailored, evidence-based brief health behaviour change intervention (leaflet', ""intervention (leaflet) or 'usual care' control (no leaflet""]","['changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour', 'adverse effects', 'self-reported screening uptake', 'country of birth, language spoken at home, and marital status', 'diabetic retinopathy', 'knowledge of diabetic retinopathy']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1277181', 'cui_str': 'Diabetic retinopathy screening'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1277523', 'cui_str': 'Country of birth - Australasian (finding)'}, {'cui': 'C0424919', 'cui_str': 'Language spoken (observable entity)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0024819', 'cui_str': 'Marital Status'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]",129.0,0.346946,"Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour.","[{'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Lake', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, 3220, Australia. alake@acbrd.org.au.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hateley-Browne', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, 3220, Australia.'}, {'ForeName': 'Gwyneth', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, 3002, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, 3220, Australia.'}]",BMC ophthalmology,['10.1186/s12886-020-1311-y']
3663,32166715,A pilot study in men to show the effects of postural fluid shifts on the severity of obstructive sleep apnea.,"PURPOSE


Studies reveal that rostral fluid shifts due to body posture changes from standing to lying down may narrow the upper airway. However, without credible and direct experimental evidence, it remains unclear what the role of natural fluid redistribution in the neck is in affecting obstructive sleep apnea (OSA) severity. Our aim is using direct experimental evidence to determine whether or not postural fluid shifts affect OSA severity.
METHODS


We performed overnight polysomnography on two consecutive nights for 22 men. The bed was set horizontally on the control night, while its tail part was lowered by 30° on the experimental night to reduce the amount of fluid shifted into the neck. We measured sleep and anthropometric parameters on each night.
RESULTS


The mean (95% CI) apnea-hypopnea index (AHI) in the supine head and trunk position decreased from 66.6 events per hour (57.6-75.6) to 61.2 (52.0-70.4) (t = 4.507, p <0.001), and the oxygen desaturation index from 69.5 events per hour (56.4-82.6) to 61.6 (50.5-72.6) (t = 3.293, p = 0.004), from the control to the experimental night with a decrease in the change of leg fluid volume from 17.7% (15.7-19.8) to 4.7% (1.9-7.5) (t = 11.659, p < 0.001).
CONCLUSIONS


Our findings provide direct experimental evidence to show that natural fluid shift caused by the day-to-night posture change does contribute to OSA pathogenesis and severity. It is likely that the neck fluid increase from an actual day-to-night position change, with 90° change in posture, would produce a much larger AHI increase than the 11.2% found in this study, which contains only a 30° change in posture. These findings suggest that reducing the amount of fluid in the neck region may relieve airway obstructions for patients with moderate and severe OSA.",2020,"The mean (95% CI) apnea-hypopnea index (AHI) in the supine head and trunk position decreased from 66.6 events per hour (57.6-75.6) to 61.2 (52.0-70.4) (t = 4.507, p <0.001), and the oxygen desaturation index from 69.5 events per hour (56.4-82.6) to 61.6 (50.5-72.6) (t = 3.293, p = 0.004), from the control to the experimental night with a decrease in the change of leg fluid volume from 17.7% (15.7-19.8) to 4.7% (1.9-7.5) (t = 11.659, p < 0.001).
","['patients with moderate and severe OSA', '22 men']",['overnight polysomnography'],"['larger AHI increase', 'oxygen desaturation index', 'change of leg fluid volume', 'severity of obstructive sleep apnea', 'apnea-hypopnea index (AHI) in the supine head and trunk position']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0459165', 'cui_str': 'Trunk position finding'}]",,0.0178496,"The mean (95% CI) apnea-hypopnea index (AHI) in the supine head and trunk position decreased from 66.6 events per hour (57.6-75.6) to 61.2 (52.0-70.4) (t = 4.507, p <0.001), and the oxygen desaturation index from 69.5 events per hour (56.4-82.6) to 61.6 (50.5-72.6) (t = 3.293, p = 0.004), from the control to the experimental night with a decrease in the change of leg fluid volume from 17.7% (15.7-19.8) to 4.7% (1.9-7.5) (t = 11.659, p < 0.001).
","[{'ForeName': 'Songjian', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Cunting', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Huixiang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Changjin', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China.'}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Biomedical Engineering, Capital Medical University, 10 Xitoutiao, Youanmenwai, Beijing, 100069, China. yqhuang@ccmu.edu.cn.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02044-x']
3664,32036562,Polarity- and Intensity-Independent Modulation of Timing During Delay Eyeblink Conditioning Using Cerebellar Transcranial Direct Current Stimulation.,"Delay eyeblink conditioning (dEBC) is widely used to assess cerebellar-dependent associative motor learning, including precise timing processes. Transcranial direct current stimulation (tDCS), noninvasive brain stimulation used to indirectly excite and inhibit select brain regions, may be a promising tool for understanding how functional integrity of the cerebellum influences dEBC behavior. The aim of this study was to assess whether tDCS-induced inhibition (cathodal) and excitation (anodal) of the cerebellum differentially impact timing of dEBC. A standard 10-block dEBC paradigm was administered to 102 healthy participants. Participants were randomized to stimulation conditions in a double-blind, between-subjects sham-controlled design. Participants received 20-min active (anodal or cathodal) stimulation at 1.5 mA (n = 20 anodal, n = 22 cathodal) or 2 mA (n = 19 anodal, n = 21 cathodal) or sham stimulation (n = 20) concurrently with dEBC training. Stimulation intensity and polarity effects on percent conditioned responses (CRs) and CR peak and onset latency were examined using repeated-measures analyses of variance. Acquisition of CRs increased over time at a similar rate across sham and all active stimulation groups. CR peak and onset latencies were later, i.e., closer to air puff onset, in all active stimulation groups compared to the sham group. Thus, tDCS facilitated cerebellar-dependent timing of dEBC, irrespective of stimulation intensity and polarity. These findings highlight the feasibility of using tDCS to modify cerebellar-dependent functions and provide further support for cerebellar contributions to human eyeblink conditioning and for exploring therapeutic tDCS interventions for cerebellar dysfunction.",2020,Acquisition of CRs increased over time at a similar rate across sham and all active stimulation groups.,['102 healthy participants'],"['Transcranial direct current stimulation (tDCS), noninvasive brain stimulation', 'tDCS-induced inhibition (cathodal) and excitation (anodal', '20-min active (anodal or cathodal) stimulation at 1.5\xa0mA (n\u2009=\u200920 anodal, n\u2009=\u200922 cathodal) or 2\xa0mA (n\u2009=\u200919 anodal, n\u2009=\u200921 cathodal) or sham stimulation (n\u2009=\u200920) concurrently with dEBC training', 'dEBC', 'Delay eyeblink conditioning (dEBC']","['Acquisition of CRs', 'percent conditioned responses (CRs) and CR peak and onset latency', 'Polarity- and Intensity-Independent Modulation of Timing', 'CR peak and onset latencies']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0034936', 'cui_str': 'Conditioned Reflex'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}]",102.0,0.155311,Acquisition of CRs increased over time at a similar rate across sham and all active stimulation groups.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mitroi', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Leah P', 'Initials': 'LP', 'LastName': 'Burroughs', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Moussa-Tooks', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Bolbecker', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Hetrick', 'Affiliation': 'Department of Psychological & Brain Sciences, Indiana University Bloomington, 1101 E. 10th St., Bloomington, IN, 47405, USA. whetrick@indiana.edu.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01114-w']
3665,32080074,A clinical pilot study to evaluate the efficacy of oral intake of phellinus linteus (sanghuang) extract on knee joint and articular cartilage: Study protocol clinical trial (SPIRIT Compliant).,"BACKGROUND


Knee osteoarthritis (KOA) is the most common form of degenerative arthritis. We used Phellinus linteus (PL), which has been well-known anti-inflammatory function. In this study, we will evaluate if PL extract improves symptoms with KOA.
METHODS


This study will be an 8-week single-center randomized controlled double-blind clinical trial. Total of 24 subjects with KOA will be enrolled and they will be divided into 3 groups, PL 1,000 mg, PL 1,500 mg and placebo. Subjects will be followed up every 4 weeks with efficacy and safety at the 2nd and 3rd visits. All subjects should maintain a dosage schedule for this protocol. The primary outcome will be assessed with the Korean version of the Western Ontario and McMasters Universities. And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen. Statistical analysis will be performed on the principle of full analysis set.
DISCUSSION


This study has inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is the first step to assess the efficacy and safety of PL in patients with KOA. This study will make an important contribution to the literature and aid follow-up research into the use of PL in KOA.",2020,"And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen.","['knee joint and articular cartilage', 'Total of 24 subjects with KOA', 'Knee osteoarthritis (KOA', 'patients with KOA']","['PL', 'PL extract', 'PL 1,000\u200amg, PL 1,500\u200amg and placebo', 'phellinus linteus (sanghuang) extract']","['efficacy and safety', 'Korean version of the Western Ontario and McMasters Universities', 'visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen']","[{'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0007303', 'cui_str': 'Cartilage, Articular'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2003783', 'cui_str': 'Phellinus linteus extract'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0009331', 'cui_str': 'Collagen Type II'}]",24.0,0.132569,"And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen.","[{'ForeName': 'Yong Ho', 'Initials': 'YH', 'LastName': 'Ku', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hwa Yeon', 'Initials': 'HY', 'LastName': 'Ryu', 'Affiliation': ''}, {'ForeName': 'Jae Hui', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018912']
3666,31988226,Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone on body weight in quitters: results of a randomised controlled trial.,"INTRODUCTION


Most people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse.
TRIAL DESIGN


An unblinded parallel randomised controlled trial.
METHODS


Participants were adult smokers with a body mass index greater or equal to 23 kg/m 2 . Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation.
RESULTS


Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of -2.3 kg 95% CI (-4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain -1.6 (-2.7 to -0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported.
CONCLUSION


In people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme.
TRIAL REGISTRATION NUMBER


ISRCTN65705512.",2020,Craving scores were lower (Mood and Physical Symptoms Scale craving domain,"['Participants were adult smokers with a body mass index greater or equal to 23\u2009kg/m 2 ', 'people who stop smoking gain weight', 'Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group', 'on body weight in quitters']","['stop smoking support alone (control group', 'Referral to Slimming World in UK Stop Smoking Services (SWISSS) versus stop smoking support alone']","['cigarette craving and smoking relapse', 'change in weight (kg', 'adverse events or side effects', 'Change in weight', 'lower (Mood and Physical Symptoms Scale craving domain', 'Craving scores', 'quit rates', 'weight gain', 'cravings and quit rates', 'weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking (finding)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",76.0,0.127858,Craving scores were lower (Mood and Physical Symptoms Scale craving domain,"[{'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Coventry, West Midlands, UK deborah.lycett@coventry.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Munafò', 'Affiliation': 'School of Experimental Psychology, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032271']
3667,31988233,"Pharmacodynamics effects of CDK4/6 inhibitor LEE011 (ribociclib) in high-risk, localised prostate cancer: a study protocol for a randomised controlled phase II trial (LEEP study: LEE011 in high-risk, localised Prostate cancer).","INTRODUCTION


Despite the development of new therapies for advanced prostate cancer, it remains the most common cause of cancer and the second leading cause of cancer death in men. It is critical to develop novel agents for the treatment of prostate cancer, particularly those that target aspects of androgen receptor (AR) signalling or prostate biology other than inhibition of androgen synthesis or AR binding. Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials. CDK4/6 inhibitors have evidence of efficacy in breast cancer, and have been shown to have activity in preclinical models of hormone sensitive and castrate resistant prostate cancer. The LEEP trial aims to assess the pharmacodynamic effects of LEE011 (ribociclib), an orally bioavailable and highly selective CDK4/6 inhibitor, in men undergoing radical prostatectomy for high-risk, localised prostate cancer.
METHODS AND ANALYSIS


The multicentre randomised, controlled 4:1 two-arm, phase II, open label pharmacodynamic study will recruit 47 men with high risk, localised prostate cancer who are planned to undergo radical prostatectomy. Participants who are randomised to receive the study treatment will be treated with LEE011 400 mg daily for 21 days for one cycle. The primary endpoint is the frequency of a 50% reduction in Ki-67 proliferation index from the pretreatment prostate biopsy compared to that present in prostate cancer tissue from radical prostatectomy. Secondary and tertiary endpoints include pharmacodynamic assessment of CDK4/6 cell cycle progression via E2F levels, apoptotic cell death by cleaved caspase-3, changes in serum and tumour levels of Prostate Specific Antigen (PSA), pathological regression, safety via incidence of adverse events and exploratory biomarker analysis.
ETHICS AND DISSEMINATION


The protocol was approved by a central ethics review committee (St Vincent's Hospital HREC) for all participating sites (HREC/17/SVH/294). Results will be disseminated in peer-reviewed journals and at scientific conferences.
DRUG SUPPLY


Novartis.
PROTOCOL VERSION


2.0, 30 May 2019 TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618000354280).",2020,Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials.,"['2.0, 30', 'advanced prostate cancer', '47 men with high risk, localised prostate cancer who are planned to undergo radical prostatectomy', 'high-risk, localised prostate cancer', 'men undergoing radical prostatectomy for high-risk, localised prostate cancer']","['CDK4/6 inhibitors', 'LEE011 (ribociclib), an orally bioavailable and highly selective CDK4/6 inhibitor', 'CDK4/6 inhibitor LEE011 (ribociclib', 'LEE011']","['pharmacodynamic assessment of CDK4/6\u2009cell cycle progression via E2F levels, apoptotic cell death by cleaved caspase-3, changes in serum and tumour levels of Prostate Specific Antigen (PSA), pathological regression, safety via incidence of adverse events and exploratory biomarker analysis', 'frequency of a 50% reduction in Ki-67 proliferation index']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2987342', 'cui_str': 'LEE011'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007586', 'cui_str': 'Cell Division Cycle'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0205242', 'cui_str': 'Cleaved (qualifier value)'}, {'cui': 'C0291573', 'cui_str': 'CASP3'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",47.0,0.0928258,Neoadjuvant pharmacodynamic studies allow for a rational approach to the decisions regarding which targeted therapies should progress to phase II/III trials.,"[{'ForeName': 'Tahlia', 'Initials': 'T', 'LastName': 'Scheinberg', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kench', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Mahon', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Lucille', 'Initials': 'L', 'LastName': 'Sebastian', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Stricker', 'Affiliation': 'Cancer Research, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': 'Cancer Research, Garvan Institute of Medical Research, Darlinghurst, New South Wales, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Woo', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ruban', 'Initials': 'R', 'LastName': 'Thanigasalam', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': ""Urology, Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Centenera', 'Affiliation': 'Prostate Cancer Research Group, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Butler', 'Affiliation': 'Prostate Cancer Research Group, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Horvath', 'Affiliation': ""Medical Oncology, Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia lisa.horvath@lh.org.au.""}]",BMJ open,['10.1136/bmjopen-2019-033667']
3668,32120378,Moderators in a physical activity intervention for adolescent girls.,"BACKGROUND


The purpose was to explore whether baseline sociodemographic and physical characteristics moderated effects of an intervention on moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF) at post intervention, relative to the control condition.
METHODS


A secondary analysis of data from a group randomized trial including 24 schools (12 intervention and 12 control; N = 1519 girls) was conducted. Age, ethnicity, race, socioeconomic status, and pubertal stage were assessed via survey. Height, weight, MVPA (min/h), percent body fat, and CRF were measured. Mixed-effects linear models were performed.
RESULTS


Compared to the control, the intervention increased overweight and obese girls' CRF (b = 0.28, p = 0.049; b = 0.31, p < 0.01, respectively), but not healthy weight girls' CRF (b = 0.04, p = 0.706). Pre- to mid-puberty girls in the intervention group had slightly lower post-intervention MVPA than those in the control (3.04 vs. 3.31, p = 0.055), while late to post-puberty intervention and control girls' post-intervention MVPA was similar (3.12 vs. 3.04, p = 0.542).
CONCLUSIONS


A PA intervention can improve overweight and obese girls' CRF, possibly attenuating their cardiovascular risk. Effective strategies are needed to assist adolescent girls, especially those in pre- to mid-puberty, in maintaining their MVPA after an intervention ends.
IMPACT


Moderators of physical activity intervention effects among adolescent girls are important to identify because the effectiveness of these interventions to date in this population has been limited. This article contributes to the notable gap in knowledge regarding moderators in physical activity interventions involving adolescent girls, particularly baseline characteristics that may moderate their responses to physical activity interventions. Awareness of the moderators can be useful for determining the type of intervention that may be successful in subgroups of adolescent girls and for tailoring a physical activity intervention to optimally meet each girl's needs to achieve maximal effects. Findings show that weight status moderated the intervention effects on cardiorespiratory fitness. Compared to the control condition, the intervention increased overweight and obese, but not healthy weight, girls' cardiorespiratory fitness. A physical activity intervention can improve overweight and obese girls' cardiorespiratory fitness, possibly attenuating their cardiovascular risk. Therefore, it is essential to include overweight and obese girls in PA interventions to help them reap this important benefit.",2020,"Compared to the control, the intervention increased overweight and obese girls' CRF (F = 4.36, p = 0.037; F = 6.56, p = 0.011, respectively), but not healthy weight girls' CRF (F = 0.01, p = 0.925).","['adolescent girls', '24 schools (12 intervention and 12 control; N\u2009=\u20091519 girls']","['physical activity intervention', 'PA intervention']","['Height, weight, MVPA (min/h), percent body fat, and CRF', 'cardiorespiratory fitness', 'moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF', ""overweight and obese girls' CRF""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",1519.0,0.0162252,"Compared to the control, the intervention increased overweight and obese girls' CRF (F = 4.36, p = 0.037; F = 6.56, p = 0.011, respectively), but not healthy weight girls' CRF (F = 0.01, p = 0.925).","[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA. robbin76@msu.edu.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Center for Family Health, 505 N Jackson St, Jackson, MI, USA.'}]",Pediatric research,['10.1038/s41390-020-0818-5']
3669,31992367,"Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol.","BACKGROUND


Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupuncture at three nasal acupoints plus acupoint application (AAP) achieves a more persistent effect in the treatment of perennial allergic rhinitis than acupuncture alone. In this study, a multicenter, single-blind, randomized controlled trial will be performed, in which acupuncture at nonmeridian acupoints and sham AAP will be used as the control group to evaluate the effect of AAP through long-term observation.
METHODS


The trial is designed on the basis of the Consolidated Standards of Reporting Trials 2010 guidelines and Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 120 participants with perennial allergic rhinitis will be randomly assigned to a treatment or control group. A specially appointed investigator will be in charge of randomization. The participants in the treatment group will be treated with acupuncture at EX-HN3, LI20, and EX-HN8 thrice per week for a total of 12 sessions. In addition, they will undergo AAP at DU14, BL13, EX-BI, and RN22. The participants in the control group will be treated with sham AAP. The primary outcome will be the change in the Total Nasal Symptom Score from baseline to the completion of 4-week treatment. Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment. Peripheral blood IL-4, IL-5, IL-6, IL-8, and IL-10 levels will be measured, and any side effects related to treatment will be observed and recorded.
DISCUSSION


It is expected that this randomized clinical trial will provide evidence to determine the effects of AAP compared with acupuncture at nonmeridian acupoints and sham AAP, particularly the long-term effect. These findings will help improve the clinical application of this technique.
TRIAL REGISTRATION


Acupuncture-Moxibustion Clinical Trial Registry AMCTR-ICR-18000179. Registered on 12 April 2018.",2020,"Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment.","['perennial allergic rhinitis', '120 participants with perennial allergic rhinitis']","['acupuncture at nonmeridian acupoints and sham AAP', 'acupuncture', 'acupuncture at EX-HN3, LI20, and EX-HN8 thrice', 'Acupuncture', 'AAP', 'sham AAP', 'nasal acupoints plus acupoint application', 'nasal acupoints plus acupoint application (AAP']","['perennial allergic rhinitis', 'changes in visual analog scale and total non-nasal symptom scores', 'Total Nasal Symptom Score', 'Peripheral blood IL-4, IL-5, IL-6, IL-8, and IL-10 levels']","[{'cui': 'C0035457', 'cui_str': 'Rhinitis, Allergic, Nonseasonal'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}, {'cui': 'C0450496', 'cui_str': 'LI20 (body structure)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0035457', 'cui_str': 'Rhinitis, Allergic, Nonseasonal'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",120.0,0.325243,"Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Acumox and Tuina Research Section, College of Acumox and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Cuihong', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Research Institute of Acupuncture and Meridians, Shanghai, China.'}, {'ForeName': 'Shifen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Acupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jin', 'Affiliation': 'Acupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Acupuncture Department, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of TCM, Shanghai, China.'}, {'ForeName': 'Bingrong', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Siwei', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kaiyong', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huiru', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Bimeng', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. pjzhtiger08@aliyun.com.'}]",Trials,['10.1186/s13063-019-4039-3']
3670,32020028,A randomised controlled trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis.,"The PROteKT study tested the hypothesis that rosuvastatin can inhibit aminoglycoside-induced nephrotoxicity in children with Cystic Fibrosis (CF). This open label, parallel group, randomised controlled trial recruited children and young people aged 6 to 18 years with CF at 13 paediatric CF treatment centres in the UK. Participants were randomised equally to either receive oral rosuvastatin (10 mg once daily) or no intervention (control) throughout clinically indicated treatment with intravenous tobramycin. The primary outcome was the difference between the groups in mean fold-change in urinary Kidney Injury Molecule-1 (KIM-1). Fifty (rosuvastatin n = 23, control n = 27) participants were recruited between May 2015 and January 2017. Primary outcome data was available for 88% (rosuvastatin n = 20, control n = 24). The estimated mean treatment difference in the geometric mean-fold change of normalised KIM-1 was 1.08 (95% CI 0.87-1.35, p = 0.48). In total there were 12 adverse reactions, all mild, reported by five participants randomised to rosuvastatin, and one serious adverse event in each group. Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort. Therefore, we can neither confirm nor refute the hypothesis that rosuvastatin protects against aminoglycoside nephrotoxicity.",2020,"Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort.","['n\u2009=\u200923, control n\u2009', 'children with cystic fibrosis', 'children and young people aged 6 to 18 years with CF at 13 paediatric CF treatment centres in the UK', '27) participants were recruited between May 2015 and January 2017', 'children with Cystic Fibrosis (CF']","['Fifty (rosuvastatin', 'oral rosuvastatin (10\u2009mg once daily) or no intervention (control) throughout clinically indicated treatment with intravenous tobramycin', 'rosuvastatin']","['mean fold-change in urinary Kidney Injury Molecule-1 (KIM-1', 'level of nephrotoxicity', 'geometric mean-fold change of normalised KIM-1', 'kidney toxicity']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",27.0,0.106176,"Whilst no protective effect of rosuvastatin was seen, there was a lower than expected level of nephrotoxicity in the cohort.","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'McWilliam', 'Affiliation': ""Department of Women's and Children's Health, University of Liverpool, Liverpool, Merseyside, United Kingdom. stevemcw@liv.ac.uk.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, a member of the Liverpool Health Partners, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shaw', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greenhalf', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rosalind L', 'Initials': 'RL', 'LastName': 'Smyth', 'Affiliation': 'University College London, Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, and MRC Centre for Drug Safety Science, University of Liverpool, Liverpool, Merseyside, United Kingdom.'}]",Scientific reports,['10.1038/s41598-020-58790-1']
3671,32029008,Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial.,"BACKGROUND


Thunder-fire moxibustion originated in China and contains traditional Chinese medicine. It can produce strong firepower, infrared thermal radiation, and medicinal effects when burning on the acupoints. Thunder-fire moxibustion is commonly used in patients with neck pain, but its efficacy has rarely been systematically demonstrated. We designed a randomized trial of thunder-fire moxibustion on cervical spondylotic radiculopathy (CSR) to investigate whether it is more effective than ibuprofen sustained-release capsules.
METHODS


One hundred patients will be recruited and randomly divided into thunder-fire moxibustion and ibuprofen groups. The intervention consists of ten treatments and will last for 2 weeks. The Yasuhisa Tanaka 20 Score Scale is used as the primary outcome measure. It contains a combination of the self-conscious symptom in patients, objective clinical evaluation from doctors, and social evaluation (the ability to work and live). The objective and comprehensive evaluation of CSR patients before and after treatment is particularly needed. The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures. The assessment will take place at the baseline and the first and second weekends of treatment. If an adverse event (AEs) occurs, it will be reported.
DISCUSSION


The aim of this trial is to determine whether thunder-fire moxibustion is more effective than ibuprofen in the treatment of patients with CSR.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR1800018820. Registered on 11 October 2018.",2020,"Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures.","['patients with CSR', 'patients with neck pain', 'cervical spondylotic radiculopathy', 'One hundred patients']","['Thunder-fire moxibustion', 'thunder-fire moxibustion and ibuprofen', 'ibuprofen', 'thunder-fire moxibustion']","['Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36', 'Yasuhisa Tanaka 20 Score Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0450043', 'cui_str': 'Thunder (event)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",100.0,0.126404,"Neck Disability Index score scale (NDI), and the Quality of Life Assessment (SF-36) are applied as secondary outcome measures.","[{'ForeName': 'Yunxuan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China.'}, {'ForeName': 'Jiabi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China.'}, {'ForeName': 'Buhui', 'Initials': 'B', 'LastName': 'Xiong', 'Affiliation': 'Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China.'}, {'ForeName': 'Ruina', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'The Eighth Affiliated Hospital of Sun Yat-sen University, No. 3025 Shennan Middle Road, Futian District, Shenzhen, 518033, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Shenzhen Pingle Orthopaedic Hospital, No.252 Hangzi Section, Pingshan Avenue, Pingshan District, Shenzhen, 518118, China.'}, {'ForeName': 'Mengxue', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Kyoto Prefectural University of Medicine, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China.'}, {'ForeName': 'Danghan', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China. xudanghan@126.com.'}, {'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No.12 Ji Chang Road, Baiyun District, Guangzhou, 510405, China. chenxinghua@gzucm.edu.cn.'}]",Trials,['10.1186/s13063-019-4012-1']
3672,31973744,"Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial.","BACKGROUND


Voluntary medical male circumcision (VMMC) is a key component of combination HIV-prevention programmes. Several high-HIV-prevalence countries in sub-Saharan Africa, including Zimbabwe, are looking to scale up VMMC activities. There is limited evidence on how a combination of social learning from peer education by a role model with different behavioural incentives influences demand for VMMC in such settings.
METHODS/DESIGN


This matched-cluster randomised controlled trial with 1740 participants will compare two behavioural incentives against a control with no intervention. In the intervention clusters, participants will participate in an education session delivered by a circumcised young male (""role model"") on the risks of HIV infection and the benefits from medical male circumcision. All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. Via blocked randomisation, in the intervention clusters participants will be randomly assigned to receive one of two types of incentives - fixed cash payment or lottery payment - both conditional on undergoing surgical VMMC. In two sites, a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at 6 months will include self-reported uptake of VMMC triangulated with clinic data.
DISCUSSION


This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments. This study will generate important knowledge to inform HIV-prevention policies about the effectiveness of behavioural interventions and incentives, which could be easily scaled-up.
TRIAL REGISTRATION


This trial has been registered on ClinicalTrials.gov (identifier: NCT03565588). Registered on 21 June 2018.",2020,This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments.,"['All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics', '1740 participants', 'Voluntary medical male circumcision (VMMC']","['education session delivered by a circumcised young male (""role model', 'incentives - fixed cash payment or lottery payment - both conditional on undergoing surgical VMMC', 'behavioural incentives against a control with no intervention']",['risk perception and self-efficacy'],"[{'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0008819', 'cui_str': 'Male Circumcision'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",1740.0,0.0637398,This is the first trial to pilot-test social learning to improve risk perception and self-efficacy and to address the fear of pain associated with VMMC and possible present-biased preferences with front-loaded compensations as well as fixed or lottery-based cash payments.,"[{'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, Cowdray House, London, WC2 2AE, UK. r.a.thomas@lse.ac.uk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Skovdal', 'Affiliation': 'Section of Health Services Research, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5 opg, B, Postb 15, Building: 15.0.17, 1014, København K, Denmark.'}, {'ForeName': 'Matteo M', 'Initials': 'MM', 'LastName': 'Galizzi', 'Affiliation': 'Department of Psychological and Behavioural Science, London School of Economics and Political Science, London, WC2 2AE, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Schaefer', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Moorhouse', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Nyamukapa', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Rufurwokuda', 'Initials': 'R', 'LastName': 'Maswera', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Mandizvidza', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gregson', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}]",Trials,['10.1186/s13063-020-4048-2']
3673,31907013,"Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: a cluster-randomised trial.","INTRODUCTION


We evaluated an intervention designed to teach 10- to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report outcomes measured 1 year after the intervention.
METHODS


In this cluster-randomised trial, we included primary schools in the central region of Uganda that taught year 5 children (aged 10 to 12 years). We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books and a teachers' guide). The primary outcomes, measured at the end of the school term and again after 1 year, were the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores.
RESULTS


We assessed 2960 schools for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n = 60 schools; 76 teachers and 6383 children) or the control group (n = 60 schools; 67 teachers and 4430 children). After 1 year, the mean score in the multiple-choice test for the intervention schools was 68.7% compared with 53.0% for the control schools (adjusted mean difference 16.7%; 95% CI, 13.9 to 19.5; P < 0.00001). In the intervention schools, 3160 (80.1%) of 3943 children who completed the test after 1 year achieved a predetermined passing score (≥ 13 of 24 correct answers) compared with 1464 (51.5%) of 2844 children in the control schools (adjusted difference, 39.5%; 95% CI, 29.9 to 47.5).
CONCLUSION


Use of the learning resources led to a large improvement in the ability of children to assess claims, which was sustained for at least 1 year.
TRIAL REGISTRATION


Pan African Clinical Trial Registry (www.pactr.org), PACTR201606001679337. Registered on 13 June 2016.",2020,"Use of the learning resources led to a large improvement in the ability of children to assess claims, which was sustained for at least 1 year.
","['primary schools in the central region of Uganda that taught year 5 children (aged 10 to 12\u2009years', '2960 schools for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings', '12-year-old primary school children', '120 eligible schools consented and were randomly assigned to either the intervention group (n\xa0=\u200960 schools; 76 teachers and 6383 children) or the control group (n\xa0=\u200960 schools; 67 teachers and 4430 children']","[""Informed Health Choices primary school resources (textbooks, exercise books and a teachers' guide"", 'Informed Health Choices primary school intervention']","['mean score', 'proportion of children with passing scores']","[{'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",2844.0,0.175219,"Use of the learning resources led to a large improvement in the ability of children to assess claims, which was sustained for at least 1 year.
","[{'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nsangi', 'Affiliation': 'College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Semakula', 'Affiliation': 'College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Oxman', 'Affiliation': 'University of Oslo, Oslo, Norway. oxman@online.no.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Austvoll-Dahlgren', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Postboks 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Oxman', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Postboks 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Postboks 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': 'Infodesignlab, Oslo, Norway.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Glenton', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Postboks 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lewin', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Postboks 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kaseje', 'Affiliation': 'Tropical Institute of Community Health & Development, Kisumu, Kenya.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Chalmers', 'Affiliation': 'James Lind Initiative, Oxford, UK.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Fretheim', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Postboks 222 Skøyen, 0213, Oslo, Norway.'}, {'ForeName': 'Nelson K', 'Initials': 'NK', 'LastName': 'Sewankambo', 'Affiliation': 'College of Health Sciences, Makerere University, Kampala, Uganda.'}]",Trials,['10.1186/s13063-019-3960-9']
3674,31883845,Short-term transcriptional response to IL-17 receptor-A antagonism in the treatment of psoriasis.,"BACKGROUND


IL-17 antagonists induce impressive clinical benefits in psoriasis, but it is unknown to what extent cellular and molecular psoriasis characteristics are suppressed by a clinically relevant dose/schedule of any IL-17-receptor antagonist.
OBJECTIVE


We sought to examine the effects of the IL-17 receptor-A antagonist brodalumab, on clinical and molecular psoriasis features over a 12-week period.
METHODS


A subset of patients (n = 116) enrolled in 3 phase-3 randomized clinical trials (AMAGINE -1 [Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects], -2 [P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis], and -3 [Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis in Subjects]) participated in a mechanistic substudy where punch biopsies were collected (lesional and nonlesional skin) between baseline and 12 weeks. This cohort included moderate-to-severe psoriasis patients treated with 140 mg (n = 46), 210 mg (n = 41) brodalumab, or placebo (n = 29). Key epidermal psoriatic features, including T-cell and dendritic cell subsets, were examined using immunohistochemistry. Treatment-induced changes in lesional skin gene expression profiles were evaluated using Affymetrix arrays.
RESULTS


IL-17 receptor-A antagonism caused extensive improvements in clinical, histologic, and transcriptomic features of psoriasis. Cellular infiltrates (CD3+, CD8+, CD11c+, CD163+), markers of keratinocyte proliferation (Ki67+, KRT16), and inflammatory cytokines (IL-17A/C/F, IL-23A, IL-12B) decreased progressively, reaching close to nonlesional levels, paralleled by decreases in epidermal thickness. Psoriasis transcriptome gene expression improved ∼85% to 95% in responders whose psoriasis area severity index improved by 75% from baseline by week 12 (n = 63), compared with ∼30% to 65% in nonresponders (n = 12), while the residual disease genomic profile was 10% of the psoriasis transcriptome, which is less than for earlier generation drugs. IL-17-dependent gene expression, including keratinocyte genes, improved earlier and more extensively following brodalumab treatment compared with ustekinumab treatment (anti-IL-23/-IL-12).
CONCLUSIONS


The clinically approved dose and schedule for brodalumab leads to nearly complete resolution of clinical, histologic, and transcriptomic features of psoriasis. Evidently, IL-17-induced release of keratinocyte-derived inflammatory mediators is a key driver of psoriasis pathogenesis.",2020,"IL-17-dependent gene expression, including keratinocyte genes, improved earlier and more extensively following brodalumab treatment compared with ustekinumab (anti-IL-23/IL-12).
","['moderate-to-severe psoriasis patients treated with 140mg (n=46), 210mg (n=41', 'Psoriasis', 'A subset of patients (n=116) enrolled in three Phase-3 randomized clinical trials (AMAGINE-1,2,3) participated in a mechanistic sub-study where punch biopsies were collected (lesional and non-lesional skin) between baseline and 12-weeks']","['brodalumab or placebo', 'IL-17 Receptor-A antagonism', 'IL-17-receptor-A antagonist brodalumab']","['Psoriasis transcriptome gene expression', 'residual disease genomic profile', 'epidermal thickness', 'Cellular infiltrates (CD3+, CD8+, CD11c+, CD163+), markers of keratinocyte proliferation (Ki67+, KRT16) and inflammatory cytokines (IL-17A/C/F, IL-23A, IL-12B', 'lesional skin gene expression profiles']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184924', 'cui_str': 'Punch biopsy (procedure)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1721056', 'cui_str': 'IL-17 Receptors'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte (cell)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}]",,0.0798895,"IL-17-dependent gene expression, including keratinocyte genes, improved earlier and more extensively following brodalumab treatment compared with ustekinumab (anti-IL-23/IL-12).
","[{'ForeName': 'Lewis E', 'Initials': 'LE', 'LastName': 'Tomalin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Chris B', 'Initials': 'CB', 'LastName': 'Russell', 'Affiliation': 'BioMarin Pharmaceutical Inc, Novato, Calif.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garcet', 'Affiliation': 'The Rockefeller University, New York, NY.'}, {'ForeName': 'David Adrian', 'Initials': 'DA', 'LastName': 'Ewald', 'Affiliation': 'Leo Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Lilly Biotechnology Center, San Diego, Calif.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Lilly Biotechnology Center, San Diego, Calif.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Norsgaard', 'Affiliation': 'Leo Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Suàrez-Fariñas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: Mayte.SuarezFarinas@mssm.edu.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, NY. Electronic address: kruegej@mail.rockefeller.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.10.041']
3675,31187344,Interventions to Reduce Unhealthy Alcohol Use among Primary Care Patients with HIV: the Health and Motivation Randomized Clinical Trial.,"BACKGROUND


Unhealthy alcohol use has adverse effects on HIV treatment. Screening, brief intervention, and referral to treatment (SBIRT) has some evidence of efficacy but may not be sufficient for those with low motivation or comorbid substance use.
OBJECTIVE


To examine the effectiveness of motivational interviewing (MI) and emailed feedback (EF) among primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT.
DESIGN


Randomized clinical trial.
PARTICIPANTS


Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use.
INTERVENTION


Participants were randomized to either three sessions of MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone. MI and EF participants who reported unhealthy alcohol use at 6 months were offered additional MI and EF treatment, respectively.
MAIN MEASURES


Participant-reported unhealthy alcohol use (defined as ≥ 4/≥ 5 drinks per day for women/men), alcohol problems at 12 months, based on blinded telephone interviews. Secondary outcomes included drug use and antiretroviral (ART) adherence.
KEY RESULTS


At 12 months, there were no overall group differences, but in all three arms, there were declines in unhealthy alcohol use and alcohol-related problems (p < 0.001). Participants reporting low motivation to reduce drinking at baseline were less likely to report unhealthy alcohol use if they received MI vs. EF and UC (p = 0.013). At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012). There were no differences in ART adherence between groups.
CONCLUSIONS


In a randomized trial of HIV-positive patients using two behavioral interventions compared with SBIRT alone, participants in all three conditions reduced unhealthy alcohol use. MI may provide added benefit for patients with low motivation or who report illegal drug use/misuse of prescription drugs.
TRIAL REGISTRATION


NCT01671501 ( ClinicalTrials.gov ).",2019,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","['Six hundred fourteen adult HIV-positive patients in Kaiser Permanente Northern California who reported prior-year unhealthy alcohol use', 'HIV-positive patients using two', 'primary care HIV-positive patients, compared with treatment as usual care (UC) only, which included SBIRT', 'patients with low motivation or who report illegal drug use/misuse of prescription drugs', 'Primary Care Patients with HIV']","['MI (one in person and two by phone), information regarding alcohol risks via EF through a patient portal, or UC alone', 'motivational interviewing (MI) and emailed feedback (EF', 'behavioral interventions', 'SBIRT alone']","['illegal drug use/misuse of prescription drugs', 'ART adherence', 'unhealthy alcohol use and alcohol-related problems', 'drug use and antiretroviral (ART) adherence']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0558078', 'cui_str': 'Low motivation (finding)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}]",614.0,0.193652,"At 6 months, reported illegal drug use/misuse of prescription drugs other than marijuana was lower in the MI arm than EF or UC (p = 0.012).","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA. derek.satre@ucsf.edu.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leyden', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Catz', 'Affiliation': 'Betty Irene Moore School of Nursing, University of California, Davis, 2450 48th Street, Suite 2600, Sacramento, CA, 95817, USA.'}, {'ForeName': 'C Bradley', 'Initials': 'CB', 'LastName': 'Hare', 'Affiliation': 'Kaiser Permanente San Francisco Medical Center, 2238 Geary Blvd, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Jang', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Lam', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Weisner', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, Box 0984, San Francisco, 401 Parnassus Avenue, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Sterling', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horberg', 'Affiliation': 'Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, 2101 East Jefferson, Rockville, MD, 20852, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Volberding', 'Affiliation': 'AIDS Research Institute, University of California, San Francisco, CA, 94158, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Silverberg', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, 94612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05065-9']
3676,31930358,An Athletic Coach-Delivered Middle School Gender Violence Prevention Program: A Cluster Randomized Clinical Trial.,"Importance


Adolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youths.
Objective


To test an athletic coach-delivered relationship abuse and sexual violence prevention program among middle school male athletes.
Design, Setting, and Participants


An unblinded cluster randomized clinical trial from spring 2015 to fall 2017 at 41 middle schools (38 clusters). The study included 973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86%).
Interventions


Coaching Boys Into Men (CBIM) is a prevention program that trains athletic coaches to talk to male athletes about (1) respectful relationship behaviors, (2) promoting more gender-equitable attitudes, and (3) positive bystander intervention when harmful behaviors among peers are witnessed.
Main Outcomes and Measures


The primary outcome was change in positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up).
Results


Of the 973 participants, 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported. Positive bystander behaviors increased at end of sports season and at 1-year follow-up (relative risk, 1.51; 95% CI, 1.06-2.16 and 1.53; 95% CI, 1.10-2.12, respectively) as did recognition of abuse (mean risk difference, 0.14; 95% CI, 0.01-0.27 and 0.14; 95% CI, 0.00-0.28, respectively). At 1-year follow-up, among those who ever dated, athletes on teams receiving CBIM had lower odds of reporting recent ARA/SV perpetration (odds ratio, 0.24; 95% CI, 0.09-0.65). Gender attitudes and intentions to intervene did not differ between study arms. In exploratory intensity-adjusted and per protocol analyses, athletes on teams receiving CBIM were more likely to report positive bystander behaviors and to endorse equitable gender attitudes and less likely to report ARA and sexual harassment perpetration 1 year later.
Conclusions and Relevance


An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
Trial Registration


ClinicalTrials.gov Identifier: NCT02331238.",2020,"An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
","[' 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported', 'spring 2015 to fall 2017 at 41 middle schools (38 clusters', 'younger adolescents', 'middle school-age youths', '973 participants', 'middle-school male athletes', '973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86', 'middle school male athletes']","['Interventions\n\n\nCoaching Boys Into Men (CBIM', 'Athletic Coach-Delivered Middle School Gender Violence Prevention Program', 'athletic coach-delivered program', 'athletic coach-delivered relationship abuse and sexual violence prevention program']","['Importance\n\n\nAdolescent relationship abuse (ARA) and sexual violence (SV', ""positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up"", 'Gender attitudes and intentions to intervene', 'Positive bystander behaviors']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0237220', 'cui_str': 'Abusive behavior (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",973.0,0.124896,"An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ripper', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paglisotti', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulbah', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5217']
3677,31733336,Frequent Versus Infrequent Bathing in Pediatric Atopic Dermatitis: A Randomized Clinical Trial.,"BACKGROUND


Studies evaluating bathing frequency in pediatric atopic dermatitis (AD) are limited. Parents of children with AD often receive conflicting information, leading to frustration and confusion.
OBJECTIVE


To evaluate efficacy of twice-daily soaking baths, followed by immediate application of an occlusive moisturizer (ie, soak-and-seal [SS]), versus twice-weekly SS baths, in the acute management of pediatric AD.
METHODS


We conducted a randomized, single-blind, crossover-controlled trial comparing frequent versus infrequent SS baths, in children 6 months to 11 years of age with moderate-to-severe AD. Children were randomized 1:1 into 2 groups: group 1 underwent twice-weekly SS baths, for 10 minutes or less, over 2 weeks (""dry method"" [DM]) followed by twice-daily SS baths, for 15 to 20 minutes, over 2 weeks (""wet method"" [WM]). Group 2 did the inverse. Patients received the same moisturizer, cleanser, and low-potency topical corticosteroid (TCS). Primary outcome was AD severity evaluated using the SCORing Atopic Dermatitis (SCORAD) index. Caregiver assessment of AD severity (Atopic Dermatitis Quickscore [ADQ]), quality of life, Staphylococcal aureus colonization, skin hydration, moisturizer, and TCS usage were assessed.
RESULTS


Of the 63 children screened, 42 fulfilled inclusion criteria and were randomized. Forty (95%) completed the study. WM decreased SCORAD by 21.2 compared with DM (95% confidence interval [CI], 14.9-27.6; P < .0001). Secondary analysis showed a greater than 30% SCORAD improvement for WM versus DM (McNemar's χ 2  = 8.83, df = 1, P = .0030). SCORAD correlated with ADQ (r = 0.66), and ADQ also showed significant improvement with WM decreasing ADQ by 5.8 (95% CI, 1.8-9.7). No other secondary endpoints showed significance.
CONCLUSIONS


As an acute treatment intervention, WM is superior to DM at improving disease severity in moderate-to-severe pediatric AD.",2020,"As an acute treatment intervention, WM is superior to DM at improving disease severity in moderate-to-severe pediatric AD.","['63 children screened, 42 fulfilled inclusion criteria and were randomized', 'pediatric atopic dermatitis (AD', 'children 6 months to 11 years of age with moderate-to-severe AD', 'Parents of children with AD', 'Pediatric Atopic Dermatitis']","['same moisturizer, cleanser, and low-potency topical corticosteroid (TCS', 'occlusive moisturizer (i.e. soak-and-seal [SS']","['WM decreasing ADQ', 'Caregiver assessment of AD severity (Atopic Dermatitis Quickscore - ADQ), quality of life, Staphylococcal aureus colonization, skin hydration, moisturizer and TCS usage', 'WM decreased SCORAD', 'AD severity evaluated using SCORing Atopic Dermatitis (SCORAD) index']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0034380'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",63.0,0.205891,"As an acute treatment intervention, WM is superior to DM at improving disease severity in moderate-to-severe pediatric AD.","[{'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Cardona', 'Affiliation': 'Department of Pediatrics, Maine Medical Center Research Institute, Portland, Maine. Electronic address: icardona001@gmail.com.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Kempe', 'Affiliation': 'Colorado Allergy and Asthma Centers, Fort Collins, Colo.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lary', 'Affiliation': 'Department of Pediatrics, Maine Medical Center Research Institute, Portland, Maine.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Ginder', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Mass.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'San Tan Allergy, Gilbert, Ariz.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.10.042']
3678,31486332,"The development and pilot study of a nurse-led HOMe-based HEart failure self-Management Programme (the HOM-HEMP) for patients with chronic heart failure, following Medical Research Council guidelines.","BACKGROUND


Chronic heart failure (CHF) is one of the most common causes of hospital admissions and readmissions. Managing CHF requires a comprehensive treatment plan that consists of medication treatment and behavioural change. However, patients often feel unprepared for their self-management role in the community, especially during the period of transition after discharge from hospital. Therefore, an effective intervention to promote CHF self-management is needed.
AIMS


This paper describes the development and pilot testing of a multicomponent nursing intervention (i.e. the HOM-HEMP) for a randomised controlled trial to assess its effectiveness in improving self-care behaviour among CHF patients in Singapore. A description of the study intervention is also delineated in detail.
METHODS


The HOM-HEMP was developed based on the UK Medical Research Council framework for developing and evaluating complex interventions. After the development of the study intervention, a single group pre- and post-repeated measure pilot test was conducted to evaluate the study intervention package for its acceptability and the feasibility of the data collection procedure. Ten participants were recruited through consecutive sampling. All of the participants received the full intervention package with the supplementary mobile application. The data were collected at baseline and immediately after the study intervention (i.e. 6 weeks from baseline). The outcome measures included the Self-Care Heart Failure Index, Cardiac Self-Efficacy Scale, Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale and Short Form of the Social Support Questionnaire.
RESULTS


The results from the pilot testing showed that the programme was feasible and potentially effective in improving patient's self-care management, psychological outcomes and health-related quality of life.
CONCLUSION


A self-management psychosocial education approach is the preferred choice for many patients with chronic diseases. The effectiveness of the HOM-HEMP will next be tested in a full scale randomised control trial.",2020,"The results from the pilot testing showed that the programme was feasible and potentially effective in improving patient's self-care management, psychological outcomes and health-related quality of life.
","['CHF patients in Singapore', 'patients with chronic diseases', 'Ten participants were recruited through consecutive sampling', 'patients with chronic heart failure, following Medical Research Council guidelines']","['HOM-HEMP', 'multicomponent nursing intervention (i.e. the HOM-HEMP', 'full intervention package with the supplementary mobile application', 'nurse-led HOMe-based HEart failure self-Management Programme (the HOM-HEMP']","['Self-Care Heart Failure Index, Cardiac Self-Efficacy Scale, Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale and Short Form of the Social Support Questionnaire', 'self-care behaviour', ""patient's self-care management, psychological outcomes and health-related quality of life""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0162335', 'cui_str': 'HEMP'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0451488', 'cui_str': 'Social support questionnaire (assessment scale)'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",10.0,0.0384089,"The results from the pilot testing showed that the programme was feasible and potentially effective in improving patient's self-care management, psychological outcomes and health-related quality of life.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Shefaly', 'Initials': 'S', 'LastName': 'Shorey', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Hoang D', 'Initials': 'HD', 'LastName': 'Nguyen', 'Affiliation': 'School of Computing Science, University of Glasgow.'}, {'ForeName': 'Vivien Xi', 'Initials': 'VX', 'LastName': 'Wu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Choy Yee', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'National University Hospital, Singapore.'}, {'ForeName': 'Lee Fung', 'Initials': 'LF', 'LastName': 'Yang', 'Affiliation': 'National University Hospital, Singapore.'}, {'ForeName': 'Karen Wei Ling', 'Initials': 'KWL', 'LastName': 'Koh', 'Affiliation': 'National University Hospital, Singapore.'}, {'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119872853']
3679,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE


To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
METHODS


As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
RESULTS


There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
CONCLUSION


Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7']
3680,32150128,"The Titanium-Coated PEEK Cage Maintains Better Bone Fusion with the Endplate than the PEEK Cage 6 Months After PLIF Surgery-A Multicenter, Prospective, Randomized Study.","STUDY DESIGN


A multicenter, randomized, open-label, parallel-group trial.
OBJECTIVE


To investigate interbody bone fusion rates in titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages after posterior lumbar interbody fusion (PLIF) surgery.
SUMMARY OF BACKGROUND DATA


Previous clinical studies have not revealed any significant difference in bone fusion rates between TiPEEK and PEEK cages.
METHODS


During one-level PLIF surgery, 149 patients (84 men, 65 women, mean age 67 years) were randomly allocated to use either a TiPEEK cage (n = 69) or PEEK cage (n = 80). Blinded radiographic evaluations were performed using computed tomography (CT) and assessed by modified intention-to-treat (mITT) analysis in 149 cases and per-protocol (PP) analysis in 143 cases who were followed for 12 months. Clinical outcomes were assessed using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and the Oswestry Disability Index (ODI).
RESULTS


The interbody union rate at 12 months after surgery was 45% owing to a very strict definition of bone fusion. The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis. Binary logistic regression analysis adjusted for sex, age, body mass index, bone mineral density, and surgical level showed that using a TiPEEK cage (odds ratio, 2.27; 95% confidence interval: 1.09-4.74; p = 0.03) was independently associated with bone fusion at 6 months after surgery. JOABPEQ and ODI results improved postoperatively in both groups.
CONCLUSIONS


Using the TiPEEK cage for PLIF enabled the maintenance of better bone fusion to the endplate than using the PEEK cage at 6 months after the surgery. Our findings suggest the possibility of an earlier return to rigorous work or sports by the use of TiPEEK cage.
LEVEL OF EVIDENCE


1.",2020,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis.,"['149 patients (84 men, 65 women, mean age 67 years']","['titanium-coated polyetheretherketone (TiPEEK) and polyetheretherketone (PEEK) cages', 'computed tomography (CT) and assessed by modified intention-to-treat (mITT) analysis', 'TiPEEK cage (n\u200a=\u200a69) or PEEK cage']","['Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and the Oswestry Disability Index (ODI', 'rates of bone fusion', 'interbody union rate', 'bone fusion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337189', 'cui_str': 'Cage, device (physical object)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}]",149.0,0.0942351,The rates of bone fusion were significantly higher at 4 and 6 months after surgery in the TiPEEK group than in the PEEK group in the unadjusted mITT analysis and were significantly higher at 6 months in the unadjusted PP analysis.,"[{'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ushirozako', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Ebata', 'Initials': 'E', 'LastName': 'Shigeto', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Ohba', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Mukaiyama', 'Affiliation': 'Department of Orthopedic Surgery, North Alps Medical Center Azumi Hospital, Kita Azumi, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopedic Surgery, Narita memorial hospital, Aichi, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yamato', 'Affiliation': 'Department of Orthopedic Surgery and Division of Geriatric Musculoskeletal Health, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ojima', 'Affiliation': 'Department of Community Health and Preventive Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopedic Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Haro', 'Affiliation': 'Department of Orthopedic Surgery, University of Yamanashi, Chuo, Yamanashi, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.'}]",Spine,['10.1097/BRS.0000000000003464']
3681,31805311,Sustained successful peanut oral immunotherapy associated with low basophil activation and peanut-specific IgE.,"BACKGROUND


Oral immunotherapy (OIT) can successfully desensitize many peanut-allergic subjects, but clinical tolerance diminishes over time on discontinuation, or low-dose maintenance, of peanut. Therefore, to improve the efficacy and sustainability of such therapy, we sought to identify biomarkers and clinical tools that can predict therapeutic outcomes and monitor treatment responses.
OBJECTIVE


We evaluated whether basophil activation in whole blood, and plasma levels of peanut-specific immunoglobulins, are useful biomarkers for peanut OIT.
METHODS


We longitudinally measured, before, during, and after OIT, basophil activation in whole blood ex vivo in response to peanut stimulation, and peanut-specific IgE (sIgE) and peanut-specific IgG 4  (sIgG 4 ), in a large, single-site, double-blind, randomized, placebo-controlled, phase 2 peanut OIT study. We compared basophil responsiveness and peanut-specific immunoglobulins between those who were clinically reactive and those who were tolerant to peanut oral challenges.
RESULTS


Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG 4 /sIgE. Participants who became reactive to 4 g of peanut 13 weeks off active OIT exhibited higher peanut-induced basophil activation ex vivo and higher peanut sIgE levels and sIgE/total IgE, but lower sIgG 4 /sIgE. Notably, participants entering the study with low basophil responsiveness were more likely to achieve treatment success. Substantial suppression of basophil activation was required to maintain long-term clinical tolerance after peanut OIT.
CONCLUSIONS


Assessments of peanut-induced basophil activation and peanut-specific immunoglobulins can help to predict treatment outcomes, and to differentiate transient desensitization versus sustained unresponsiveness after OIT.",2020,"Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG",[],"['placebo', 'Oral immunotherapy (OIT', 'peanut-specific IgE (sIgE) and peanut-specific IgG 4  ']","['basophil activation ex\xa0vivo and higher peanut sIgE levels and sIgE/total IgE, but lower sIgG', 'basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG', 'low basophil activation and peanut-specific IgE']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0063241', 'cui_str': 'hypoxanthine arabinoside'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}]",,0.0751136,"Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG","[{'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Galli', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford, Calif. Electronic address: sgalli@stanford.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.10.038']
3682,31748596,Noisy galvanic vestibular stimulation has a greater ameliorating effect on posture in unstable subjects: a feasibility study.,"Ameliorating effect of noisy galvanic vestibular stimulation (nGVS) on posture varies among subjects. In this feasibility study, we investigated the association between original postural instability and the ameliorating effect of nGVS on posture. Data were collected in a previously published study. Thirty healthy elderly were recruited. Two nGVS sessions (30 min or 3 h) were performed in a randomised order. The optimal intensity of nGVS, the most effective intensity for improving posture, was determined before each session. Posture was measured for 30 s during and after nGVS in the eyes-closed/foam rubber condition. The velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS were significantly larger in the group with an optimal intensity than those in the group without an optimal intensity. There was a significant positive correlation between these values and the long-term ameliorating effects. The ratio of the values in the eyes-closed/foam rubber condition to those in the eyes-open condition was significantly larger in the group with an optimal intensity, and had a significant correlation with the long-term ameliorating effects. The ameliorating effects are greater in subjects who were originally unstable and in those whose postural stability was relatively independent of vestibular input.",2019,"The velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS were significantly larger in the group with an optimal intensity than those in the group without an optimal intensity.","['unstable subjects', 'subjects', 'Thirty healthy elderly were recruited']","['nGVS', 'Noisy galvanic vestibular stimulation', 'noisy galvanic vestibular stimulation (nGVS']","['velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS']","[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",30.0,0.0313577,"The velocity, envelopment area, and root mean square of the centre of pressure movement without nGVS were significantly larger in the group with an optimal intensity than those in the group without an optimal intensity.","[{'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. cfujimoto-tky@umin.ac.jp.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Teru', 'Initials': 'T', 'LastName': 'Kamogashira', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Egami', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kawahara', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, The University of Tokyo Hospital 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Educational Physiology Laboratory, Graduate School of Education, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Yamasoba', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology and Head and Neck Surgery, Graduate School of Medicine, The University of Tokyo 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}]",Scientific reports,['10.1038/s41598-019-53834-7']
3683,31619359,Cross-Linking-Assisted Infection Reduction: A Randomized Clinical Trial Evaluating the Effect of Adjuvant Cross-Linking on Outcomes in Fungal Keratitis.,"PURPOSE


To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare natamycin versus amphotericin B for filamentous fungal keratitis.
DESIGN


Outcome-masked, 2×2 factorial design, randomized controlled clinical trial.
PARTICIPANTS


Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India.
METHODS


Study eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical natamycin 5% alone, (2) topical natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL.
MAIN OUTCOME MEASURES


The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events.
RESULTS


Those randomized to CXL regardless of medication (topical natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57-3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47-2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, -0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03-0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications.
CONCLUSIONS


There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.",2020,"There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications.
","['Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India', 'Study eyes', 'Fungal Keratitis']","['Adjuvant Cross-Linking', 'Cross-Linking-Assisted Infection Reduction', 'CXL', 'natamycin versus amphotericin B', 'amphotericin', 'topical natamycin 5% alone, (2) topical natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL', 'medication (topical natamycin or amphotericin', 'adjuvant corneal crosslinking (CXL']","['24-hour culture positivity', 'microbiological cure at 24 hours on repeat culture', 'odds of 24-hour culture positivity', 'spectacle-corrected visual acuity (BSCVA', 'baseline visual acuity', 'visual acuity', 'infiltrate or scar size, percentage of epithelialized or adverse events', 'epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}, {'cui': 'C0002679', 'cui_str': 'Amphotericin B'}, {'cui': 'C0085795', 'cui_str': 'Amphotericin'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]",,0.445403,"There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications.
","[{'ForeName': 'N Venkatesh', 'Initials': 'NV', 'LastName': 'Prajna', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Radhakrishnan', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Prajna', 'Initials': 'P', 'LastName': 'Lalitha', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California, San Francisco, San Francisco, California; The Permanente Medical Group, Redwood City, California. Electronic address: jennifer.rose.nussbaumer@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2019.08.029']
3684,32001783,Whole-body vibration modulates leg muscle reflex and blood perfusion among people with chronic stroke: a randomized controlled crossover trial.,"This study aimed to investigate the acute effect of whole-body vibration (WBV) on the reflex and non-reflex components of spastic hypertonia and intramuscular blood perfusion among individuals with chronic stroke. Thirty-six people with chronic stroke (age: 61.4 ± 6.9 years) participated in this randomized controlled cross-over study. Each participant underwent two testing conditions: static standing for 5 minutes with WBV (30 Hz, 1.5 mm) or no-vibration. We assessed the soleus H-reflex, shear modulus (ultrasound elastography) and vascular index (color power Doppler ultrasound) of the medial gastrocnemius (MG) muscle on either paretic or non-paretic side at baseline and every 1-min post-intervention up to 5 minutes. The results revealed a significant inhibition of the H/M ratio bilaterally for the WBV condition (absolute change on paretic side: 0.61 ± 0.35, p = 0.001; non-paretic side: 0.34 ± 0.23, p = 0.001), but not the control condition. The inhibition of H-reflex was sustained up to 4 minutes and 3 minutes on the paretic and non-paretic side, respectively. The vascular index of MG muscle was significantly increased only for the WBV condition [paretic: from 0.55 ± 0.07 to 1.08 ± 0.18 (p = 0.001); non-paretic: from 0.82 ± 0.09 to 1.01 ± 0.13 (p < 0.001)], which lasted for 3 minutes and 5 minutes, respectively. No significant change of the shear modulus in the MG muscle was observed, regardless of the testing condition. Based on our results, WBV had an acute effect on modulating spastic hypertonia dominated by hyperreflexia in people with chronic stroke and facilitating greater intramuscular blood perfusion. No acute effect on passive muscle stiffness was observed.",2020,"The inhibition of H-reflex was sustained up to 4 minutes and 3 minutes on the paretic and non-paretic side, respectively.","['Thirty-six people with chronic stroke (age: 61.4\u2009±\u20096.9 years', 'people with chronic stroke', 'individuals with chronic stroke']","['static standing for 5\u2009minutes with WBV (30\u2009Hz, 1.5\u2009mm) or no-vibration', 'whole-body vibration (WBV', 'Whole-body vibration modulates leg muscle reflex and blood perfusion']","['spastic hypertonia', 'soleus H-reflex, shear modulus (ultrasound elastography) and vascular index (color power Doppler ultrasound) of the medial gastrocnemius (MG) muscle on either paretic or non-paretic side', 'intramuscular blood perfusion', 'shear modulus', 'vascular index of MG muscle', 'passive muscle stiffness', 'inhibition of H-reflex']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0005768'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0026826', 'cui_str': 'Hypermyotonia'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C3163956', 'cui_str': 'Ultrasound elastography'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1960437', 'cui_str': 'Power doppler ultrasound'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",36.0,0.0244558,"The inhibition of H-reflex was sustained up to 4 minutes and 3 minutes on the paretic and non-paretic side, respectively.","[{'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Tiev', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ying', 'Affiliation': 'Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Marco Y C', 'Initials': 'MYC', 'LastName': 'Pang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong. marco.pang@polyu.edu.hk.'}]",Scientific reports,['10.1038/s41598-020-58479-5']
3685,31791675,Comprehensive assessment of side effects associated with a single dose of ketamine in treatment-resistant depression.,"BACKGROUND


Concerns about ketamine for treating depression include abuse potential and the occurrence of psychotomimetic effects. This study sought to comprehensively assess side effects (SEs) associated with a single subanesthetic-dose intravenous ketamine infusion. A secondary aim was to examine the relationship between Clinician-Administered Dissociative States Scale (CADSS) scores and dissociative symptoms reported on a comprehensive, clinician-administered SE questionnaire.
METHODS


Data from 188 participants were pooled from four placebo-controlled, crossover ketamine trials and one open-label study (n = 163 with either treatment-resistant major depressive disorder or bipolar disorder and 25 healthy controls). SEs were actively solicited in a standardized fashion and monitored over the time-course of each study. Statistical analyses assessed the effect of drug (ketamine, placebo) on SEs and measured the relationship between CADSS total score and SEs contemporaneously endorsed during structured interviews.
RESULTS


Forty-four of 120 SEs occurred in at least 5% of participants over all trials. Thirty-three of these 44 SEs were significantly associated with active drug administration (versus placebo). The most common SE was feeling strange/weird/loopy. Most SEs peaked within an hour of ketamine administration and resolved completely by two hours post-infusion. No serious drug-related adverse events or increased ketamine craving/abuse post-administration were observed. A positive correlation was found between dissociative SEs and total CADSS score.
LIMITATIONS


The post-hoc nature of the analysis; the limited generalizability of a single subanesthetic-dose ketamine infusion; and the lack of formal measures to assess ketamine's cognitive, urological, or addictive potential.
CONCLUSIONS


No long-lasting significant SEs occurred over the approximately three-month follow-up period.",2020,No serious drug-related adverse events or increased ketamine craving/abuse post-administration were observed.,"['Data from 188 participants were pooled from four placebo-controlled, crossover ketamine trials and one open-label study (n\u202f=\u202f163 with either treatment-resistant major depressive disorder or bipolar disorder and 25 healthy controls']","['drug (ketamine, placebo', 'ketamine']","['side effects (SEs', 'dissociative SEs and total CADSS score', 'Clinician-Administered Dissociative States Scale (CADSS) scores and dissociative symptoms']","[{'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0851878', 'cui_str': 'Dissociative states'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",188.0,0.142965,No serious drug-related adverse events or increased ketamine craving/abuse post-administration were observed.,"[{'ForeName': 'Elia E', 'Initials': 'EE', 'LastName': 'Acevedo-Diaz', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: elia.acevedodiaz@nih.gov.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Cavanaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Dede', 'Initials': 'D', 'LastName': 'Greenstein', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Building 10, CRC Room 7-5545, 10 Center Drive, Bethesda, MD 20892, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.028']
3686,32024852,The gender dependent influence of sodium bicarbonate supplementation on anaerobic power and specific performance in female and male wrestlers.,"The aim of this study was the assessment of progressive low-dose sodium bicarbonate (NaHCO 3 ) supplementation on the anaerobic indices in two bouts of Wingate tests (WT) separated by wrestling-specific performance test and assessing the gender differences in response. Fifty-one (18 F) wrestlers completed a randomized trial of either a NaHCO 3  (up to 100 mg·kg -1 ) or a placebo for 10 days. Before and after treatment, athletes completed an exercise protocol that comprised, in sequence, the first WT 1 , dummy throw test (DT), and second WT 2 . The number of completed throws increased significantly in males from 19.3 ± 2.6 NaHCO 3pre  to 21.7 ± 2.9 NaHCO 3post . ΔWT 2 -WT 1  improved particularly in the midsection of 30-s WT on NaHCO 3 . However, no significant differences were found in peak power (PP), power drop (PD) and average power (AP) (analyzed separately for each WT), and ΔWT 2 -WT 1  in PP and PD. Interaction with gender was significant for AP, PP and PD, every second of WT 1  and WT 2 , as well as DT test. In conclusion, our study suggests that the response to NaHCO 3  may be gender-specific and progressive low-dose NaHCO 3  supplementation allows the advantageous strengthening of wrestling-specific performance in males. It can also lead to maintenance of high anaerobic power mainly in the midsection of the 30-s Wingate test.",2020,"Interaction with gender was significant for AP, PP and PD, every second of WT 1  and WT 2 , as well as DT test.","['Fifty-one (18\u2009F) wrestlers', 'female and male wrestlers']","['NaHCO', 'placebo', 'sodium bicarbonate (NaHCO 3 ) supplementation', 'sodium bicarbonate supplementation']","['peak power (PP), power drop (PD) and average power (AP', 'anaerobic power and specific performance']","[{'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",,0.0477219,"Interaction with gender was significant for AP, PP and PD, every second of WT 1  and WT 2 , as well as DT test.","[{'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Durkalec-Michalski', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, 60-624, Poland. durkmich@up.poznan.pl.'}, {'ForeName': 'Emilia E', 'Initials': 'EE', 'LastName': 'Zawieja', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, 60-624, Poland.'}, {'ForeName': 'Bogna E', 'Initials': 'BE', 'LastName': 'Zawieja', 'Affiliation': 'Department of Mathematical and Statistical Methods, Poznań University of Life Sciences, Poznań, 60-637, Poland.'}, {'ForeName': 'Patrycja', 'Initials': 'P', 'LastName': 'Michałowska', 'Affiliation': 'Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences, Poznań, 60-624, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Podgórski', 'Affiliation': 'Department od Physiology and Biochemistry, Poznań University of Physical Education, Poznań, 61-871, Poland.'}]",Scientific reports,['10.1038/s41598-020-57590-x']
3687,30953731,Randomized Trial of a Computer-Assisted Intervention for Children With Autism in Schools.,"OBJECTIVE


Computer-assisted interventions (CAIs) are popular for educating children with autism, but their effectiveness is not well established. This study evaluated the effectiveness of 1 CAI designed to improve children's language, cognitive, and academic skills, TeachTown: Basics, in a large urban school district.
METHOD


Teachers (n = 59) in autism support classrooms and their consented students in kindergarten through second grade (n = 154) were randomized to TeachTown: Basics or waitlist control. Child outcome was measured at baseline and after 1 academic year using the Bracken Basic Concepts Scale-Receptive and Expressive versions and the Differential Ability Scales, Second Edition (DAS-II). Random effects regression models that included clustering of time within students and students within classrooms were used to test whether the change over time in each outcome differed between groups.
RESULTS


There were no statistically significant differences in outcomes for children who received TeachTown: Basics or treatment as usual. Increased time spent using TeachTown: Basics was associated with worse receptive language outcomes for children in the experimental group after 1 academic year. However, there was no association between minutes spent using TeachTown and changes in expressive language or DAS-II score.
CONCLUSION


Despite growing enthusiasm for CAIs in autism treatment, the present findings indicate that CAI might not be effective at improving language and cognitive outcomes for children with autism spectrum disorder. The decision to implement CAIs in schools should be carefully balanced against the evidence for effectiveness of these programs. Schools might be better served by investing in treatment strategies with established evidence.
CLINICAL TRIAL REGISTRATION INFORMATION


RCT of TeachTown in Autism Support Classrooms: Innovation and Exnovation; https://clinicaltrials.gov/; NCT02695693.",2020,"Increased time spent using TeachTown: Basics was associated with worse receptive language outcomes for children in the experimental group after one academic year, however there was no association between minutes spent using TeachTown and changes in expressive language or DAS-II score.
","['children with ASD', 'children with autism', 'Children With Autism in Schools', 'large urban school district', 'Teachers (n = 59) in autism support classrooms and their consented students in kindergarten through second grade (n = 154']","['Computer-assisted interventions (CAI', 'Computer-Assisted Intervention', 'TeachTown: Basics or waitlist control', 'TeachTown']","['receptive language outcomes', 'Bracken Basic Concepts Scale - Receptive & Expressive versions, and the Differential Ability Scales, 2 nd  Edition', 'language and cognitive outcomes', 'expressive language or DAS-II score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0051767', 'cui_str': 'DASD'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",154.0,0.0636209,"Increased time spent using TeachTown: Basics was associated with worse receptive language outcomes for children in the experimental group after one academic year, however there was no association between minutes spent using TeachTown and changes in expressive language or DAS-II score.
","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pellecchia', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia. Electronic address: pmelanie@upenn.edu.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Spaulding', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Seidman', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Keiran', 'Initials': 'K', 'LastName': 'Rump', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Reisinger', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Mandell', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.03.029']
3688,30699054,A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy.,"BACKGROUND


E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.
METHODS


We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.
RESULTS


A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.
CONCLUSIONS


E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support. (Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN60477608 .).",2019,"The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9).","['886 participants underwent randomization', 'We randomly assigned adults attending U.K. National Health Service stop-smoking services to either']","['E-Cigarettes versus Nicotine-Replacement Therapy', 'nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter']","['Overall, throat or mouth irritation', 'sustained abstinence for 1 year', 'incidence of wheezing or shortness of breath', '1-year abstinence rate', 'incidence of cough and phlegm production', 'participant-reported treatment usage and respiratory symptoms', 'nausea']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3179143', 'cui_str': 'Nicotine Replacement Products'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C0439526', 'cui_str': 'per milliliter'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0235339', 'cui_str': 'Mouth irritation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0225378', 'cui_str': 'Upper respiratory tract mucus (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",886.0,0.146666,"The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Myers Smith', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bisal', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Goniewicz', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}, {'ForeName': 'Hayden J', 'Initials': 'HJ', 'LastName': 'McRobbie', 'Affiliation': ""From Queen Mary University of London (P.H., A.P.-W., D.P., K.M.S., N.B., H.J.M.), King's College London (F.P., P.S.), and London South Bank University (L.D.), London, the University of York, York (J.L., S.P., Q.W.), and Leicester City Council, Leicester (L.R.) - all in the United Kingdom; and Roswell Park Comprehensive Cancer Center, Buffalo, NY (M.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa1808779']
3689,31734121,Effect of Protein Supplementation on Physical Performance in Older People With Sarcopenia-A Randomized Controlled Trial.,"OBJECTIVES


To test the long-term effects of whey-enriched protein supplementation on muscle and physical performance.
DESIGN


A 12-month randomized controlled double blind trial with a 43-month of post-trial follow-up.
SETTING


Porvoo, Finland.
PARTICIPANTS


A total of 218 older (>74 years of age) community-dwelling people with sarcopenia.
INTERVENTION


(1) Control with no supplementation; (2) isocaloric placebo; and (3) 20 g × 2 whey-enriched protein supplementation. All participants were given instructions on home-based exercise, dietary protein, and vitamin D supplementation of 20 μg/d.
MEASUREMENTS


Physical performance was assessed by short physical performance battery and continuous summary physical performance scores. Hand grip strength and calf intracellular resistance based skeletal muscle index were measured by bioimpedance spectroscopy. The measurements were performed at 0, 6, and 12 months. The post-trial follow-up was performed by a postal questionnaire and national census record data.
RESULTS


The participants were older (75-96 years of age) and mostly women (68%). The test supplements had no significant effects on physical performance; the 12-month changes for short physical performance battery were -0.55, -.05, and 0.03 points in control, isocaloric, and protein groups (P = .17), respectively. The changes in continuous summary physical performance scores were similar between the intervention groups (P = .76). The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups. One-half of the patients (56%) in both supplement groups reported mild gastrointestinal adverse effects. Differences were found neither in the all-cause mortality nor physical functioning in the post-trial follow-up.
CONCLUSIONS


The whey-enriched protein supplementation in combination with low intensity home-based physical exercise did not attenuate the deterioration of muscle and physical performance in community-dwelling older people with sarcopenia.",2020,"The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups.","['Older People With Sarcopenia', 'A total of 218 older (>74\xa0years of age) community-dwelling people with sarcopenia', 'participants were older (75-96\xa0years of age) and mostly women (68', 'community-dwelling older people with sarcopenia', 'Porvoo, Finland']","['1) Control with no supplementation; (2) isocaloric placebo; and (3) 20\xa0g\xa0×\xa02 whey-enriched protein supplementation', 'whey-enriched protein supplementation', 'instructions on home-based exercise, dietary protein, and vitamin D supplementation of 20\xa0μg/d', 'whey-enriched protein supplementation in combination with low intensity home-based physical exercise', 'Protein Supplementation']","['Physical Performance', 'short physical performance battery', 'hand grip strength', 'short physical performance battery and continuous summary physical performance scores', 'calf intracellular resistance-based skeletal muscle index', 'mild gastrointestinal adverse effects', 'muscle and physical performance', 'physical performance', 'Physical performance', 'continuous summary physical performance scores', 'deterioration of muscle and physical performance', 'Hand grip strength and calf intracellular resistance based skeletal muscle index']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",218.0,0.0864948,"The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups.","[{'ForeName': 'Mikko P', 'Initials': 'MP', 'LastName': 'Björkman', 'Affiliation': 'Geriatric Unit, Department of Internal Medicine, University of Helsinki, Helsinki, Finland. Electronic address: bjorkmik@gmail.com.'}, {'ForeName': 'Merja H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Unit of General Practice, Helsinki University Central Hospital, and University of Helsinki, Helsinki, Finland; Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Unit of General Practice, Helsinki University Central Hospital, and University of Helsinki, Helsinki, Finland; Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Satu K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Harriet U', 'Initials': 'HU', 'LastName': 'Finne-Soveri', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Timo E', 'Initials': 'TE', 'LastName': 'Strandberg', 'Affiliation': 'Geriatric Unit, Department of Internal Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Unit of General Practice, Helsinki University Central Hospital, and University of Helsinki, Helsinki, Finland; Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Reijo S', 'Initials': 'RS', 'LastName': 'Tilvis', 'Affiliation': 'Geriatric Unit, Department of Internal Medicine, University of Helsinki, Helsinki, Finland.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.09.006']
3690,30649593,Vitamin D supplementation increases adipokine concentrations in overweight or obese adults.,"PURPOSE


Vitamin D regulates adipokine production in vitro; however, clinical trials have been inconclusive. We conducted secondary analyses of a randomized controlled trial to examine whether vitamin D supplementation improves adipokine concentrations in overweight/obese and vitamin D-deficient adults.
METHODS


Sixty-five individuals with a BMI ≥ 25 kg/m 2  and 25-hydroxyvitamin D (25(OH)D) ≤ 50 nmol/L were randomized to oral cholecalciferol (100,000 IU single bolus followed by 4,000 IU daily) or matching placebo for 16 weeks. We measured BMI, waist-to-hip ratio, % body fat (dual X-ray absorptiometry), serum 25(OH)D (chemiluminescent immunoassay) and total adiponectin, leptin, resistin, and adipsin concentrations (multiplex assay; flow cytometry). Sun exposure, physical activity, and diet were assessed using questionnaires.
RESULTS


Fifty-four participants completed the study (35M/19F; mean age = 31.9 ± 8.5 years; BMI = 30.9 ± 4.4 kg/m 2 ). After 16 weeks, vitamin D supplementation increased 25(OH)D concentrations compared with placebo (57.0 ± 21.3 versus 1.9 ± 15.1 nmol/L, p < 0.001). There were no differences between groups for changes in adiponectin, leptin, resistin, or adipsin in unadjusted analyses (all p > 0.05). After adjustment for baseline values, season, sun exposure, and dietary vitamin D intake, there was a greater increase in adiponectin (β[95%CI] = 13.7[2.0, 25.5], p = 0.02) and leptin (β[95%CI] = 22.3[3.8, 40.9], p = 0.02) in the vitamin D group compared with placebo. Results remained significant after additional adjustment for age, sex, and % body fat (p < 0.02).
CONCLUSIONS


Vitamin D may increase adiponectin and leptin concentrations in overweight/obese and vitamin D-deficient adults. Further studies are needed to clarify the molecular interactions between vitamin D and adipokines and the clinical implications of these interactions in the context of obesity.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov: NCT02112721.",2020,"There were no differences between groups for changes in adiponectin, leptin, resistin, or adipsin in unadjusted analyses (all p > 0.05).","['mean age\u2009=\u200931.9\u2009±\u20098.5 years; BMI\u2009=\u200930.9\u2009±\u20094.4\xa0kg/m 2 ', 'Sixty-five individuals with a BMI\u2009≥\u200925\xa0kg/m 2  and 25-hydroxyvitamin D (25(OH)D)\u2009≤\u200950\xa0nmol/L', 'overweight/obese and vitamin D-deficient adults', 'overweight or obese adults', 'Fifty-four participants completed the study (35M/19F']","['vitamin D', 'matching placebo', 'vitamin D supplementation', 'placebo', 'Vitamin D', 'Vitamin D supplementation', 'oral cholecalciferol']","['adipokine concentrations', 'BMI, waist-to-hip ratio, % body fat (dual X-ray absorptiometry), serum 25(OH)D (chemiluminescent immunoassay) and total adiponectin, leptin, resistin, and adipsin concentrations (multiplex assay; flow cytometry', '25(OH)D concentrations', 'adiponectin (β[95%CI', 'adiponectin, leptin, resistin, or adipsin', 'baseline values, season, sun exposure, and dietary vitamin D intake', 'Sun exposure, physical activity, and diet', 'adiponectin and leptin concentrations']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}]","[{'cui': 'C1955907', 'cui_str': 'Adipocytokines'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0963992', 'cui_str': 'Adipocyte Cysteine-Rich Secreted Protein FIZZ3'}, {'cui': 'C0033457', 'cui_str': 'Properdin Factor D'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",65.0,0.554161,"There were no differences between groups for changes in adiponectin, leptin, resistin, or adipsin in unadjusted analyses (all p > 0.05).","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Mousa', 'Affiliation': 'Monash Centre for Health Research and Implementation (MCHRI), School of Public Health and Preventive Medicine, Monash University, Level 1, 43-51 Kanooka Grove, Clayton, Melbourne, VIC, 3168, Australia.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Naderpoor', 'Affiliation': 'Monash Centre for Health Research and Implementation (MCHRI), School of Public Health and Preventive Medicine, Monash University, Level 1, 43-51 Kanooka Grove, Clayton, Melbourne, VIC, 3168, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Immunology and Pathology, Monash University, 89 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Plebanski', 'Affiliation': 'Department of Immunology and Pathology, Monash University, 89 Commercial Road, Melbourne, VIC, 3004, Australia.'}, {'ForeName': 'Maximilian P J', 'Initials': 'MPJ', 'LastName': 'de Courten', 'Affiliation': 'Centre for Chronic Disease, Victoria University, 176 Furlong Road, St Albans, Melbourne, VIC, 3021, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Scragg', 'Affiliation': 'School of Population Health, University of Auckland, 261 Morrin Road, Glen Innes, Auckland, 1072, New Zealand.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'de Courten', 'Affiliation': 'Monash Centre for Health Research and Implementation (MCHRI), School of Public Health and Preventive Medicine, Monash University, Level 1, 43-51 Kanooka Grove, Clayton, Melbourne, VIC, 3168, Australia. barbora.decourten@monash.edu.'}]",European journal of nutrition,['10.1007/s00394-019-01899-5']
3691,32005283,"Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial.","BACKGROUND


The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases. This pilot study will assess the feasibility of using DST in obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial.
METHODS/DESIGN


This is a study protocol for a randomised, double-blind, parallel-group, stratified, placebo-controlled pilot trial. We will recruit a total of 60 participants with NAFLD who have a body mass index ≥ 25 kg/m 2 . They will take either DST or placebo (3 g, three times daily) for 12 weeks with a 4-week follow-up period. The effects of DST will be evaluated by the mean change in body weight as the primary measurement and other secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire). Faecal samples will be collected before and after the intervention for a gut microbial analysis.
DISCUSSION


In anticipation of conducting further large-scale trials, in this study we will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters, in obese patients with NAFLD. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis.
TRIAL REGISTRATION


Korean Clinical Trial Registry, KCT0003554. Registered on 25 February 2019.",2020,"Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases.","['60 participants with NAFLD who have a body mass index ≥', 'obese patients with NAFLD', 'obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial', 'obesity with non-alcoholic fatty liver disease']","['Daesiho-tang (DST', 'DST', 'Daesiho-tang', 'DST or placebo', 'placebo']","['secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0222045'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.596379,"Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases.","[{'ForeName': 'Kyungsun', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Ojin', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyo-Ju', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Changsop', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea. yangunja@kiom.re.kr.'}, {'ForeName': 'Chang-Gue', 'Initials': 'CG', 'LastName': 'Son', 'Affiliation': 'Liver-Immune Research Center, Dunsan Hospital of Daejeon University, Daejeon, Republic of Korea. ckson@dju.kr.'}]",Trials,['10.1186/s13063-020-4068-y']
3692,29802051,Transurethral Resection of Bladder Tumors: Next-generation Virtual Reality Training for Surgeons.,"BACKGROUND


The number of virtual reality (VR) simulators is increasing. The aim of this prospective trial was to determine the benefit of VR cystoscopy (UC) and transurethral bladder tumor resection (TURBT) training in students.
DESIGN, SETTING, AND PARTICIPANTS


Medical students without endoscopic experience (n=51, median age=25 yr, median 4th academic year) were prospectively randomized into groups A and B. After an initial VR-UC and VR-TURBT task, group A (n=25) underwent a video-based tutorial by a skilled expert. Group B (n=26) was trained using a VR training program (Uro-Trainer). Following the training, every participant performed a final VR-UC and VR-TURBT task. Performance indicators were recorded via the simulator. Data was analyzed by Mann-Whitney U test.
INTERVENTION


VR cystoscopy and TURBT.
RESULTS AND LIMITATIONS


No baseline and post-training differences were found for VR-UC between groups. During baseline, VR-TURBT group A showed higher inspected bladder surface than group B (56% vs 73%, p=0.03). Subgroup analysis detected differences related to sex before training (male: 31.2% decreased procedure time; 38.1% decreased resectoscope movement; p=0.02). After training, significant differences in procedure time (3.9min vs 2.7min, p=0.007), resectoscope movement (857mm vs 529mm, p=0.005), and accidental bladder injury (n=3.0 vs n=0.88, p=0.003) were found. Male participants showed reduced blood loss (males: 3.92ml vs females: 10.12ml; p=0.03) after training.
CONCLUSIONS


Measuring endoscopic skills within a virtual environment can be done easily. Short training improved efficacy and safety of VR-TURBT. Nevertheless, transfer of improved VR performance into real world surgery needs further clarification.
PATIENT SUMMARY


We investigated how students without endoscopic experience profit from simulation-based training. The safe environment and repeated simulations can improve the surgical training. It may be possible to enhance patient's safety and the training of surgeons in long term.",2019,"After training, significant differences in procedure time (3.9min vs 2.7min, p=0.007), resectoscope movement (857mm vs 529mm, p=0.005), and accidental bladder injury (n=3.0 vs n=0.88, p=0.003) were found.","['of Bladder Tumors', 'males', 'students without endoscopic experience profit from simulation-based training', 'students', 'Male participants', 'Medical students without endoscopic experience (n=51, median age=25 yr, median 4th academic year']","['Transurethral Resection', 'VR cystoscopy (UC) and transurethral bladder tumor resection (TURBT) training', 'VR training program (Uro-Trainer', 'VR cystoscopy and TURBT', 'video-based tutorial by a skilled expert']","['procedure time', 'blood loss', 'resectoscope movement', 'accidental bladder injury', 'efficacy and safety of VR-TURBT', 'VR-UC', 'bladder surface']","[{'cui': 'C0005695', 'cui_str': 'Bladder Tumors'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0740283', 'cui_str': 'Bladder tumour resection'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0403677', 'cui_str': 'Injury of bladder (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",,0.0229945,"After training, significant differences in procedure time (3.9min vs 2.7min, p=0.007), resectoscope movement (857mm vs 529mm, p=0.005), and accidental bladder injury (n=3.0 vs n=0.88, p=0.003) were found.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Neumann', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Giorgio Ivan', 'Initials': 'GI', 'LastName': 'Russo', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany; University of Catania, Urology Section, Catania, Italy.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Amend', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rausch', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Deininger', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Harland', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Inês Anselmo', 'Initials': 'IA', 'LastName': 'da Costa', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hennenlotter', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kruck', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bedke', 'Affiliation': 'University Tuebingen, Dept. of Urology, Tuebingen, Germany. Electronic address: bedke@live.com.'}]",European urology focus,['10.1016/j.euf.2018.04.011']
3693,31366417,Stress effects on cognitive function in patients with major depressive disorder: Does childhood trauma play a role?,"Impaired cognitive functioning constitutes an important symptom of major depressive disorder (MDD), potentially associated with elevated cortisol levels. Adverse childhood experiences (ACE) enhance the risk for MDD and can contribute to disturbances in the stress systems, including cortisol and cognitive functions. In healthy participants, cortisol administration as well as acute stress can affect cognitive performance. In the current study, we tested cognitive performance in MDD patients with (N = 32) and without (N = 52) ACE and healthy participants with (N = 22) and without (N = 37) ACE after psychosocial stress induction (Trier Social Stress Test, TSST) and a control condition (Placebo-TSST). MDD predicted lower performance in verbal learning and both selective and sustained attention, while ACE predicted lower performance in psychomotoric speed and working memory. There were no interaction effects of MDD and ACE. After stress, MDD patients were more likely to show lower performance in working memory as well as in selective and sustained attention compared with participants without MDD. Individuals with ACE were more likely to show lower performance in verbal memory after stress compared with individuals without ACE. Our results indicate negative effects of MDD and ACE on distinct cognitive domains. Furthermore, MDD and/or ACE seem to enhance susceptibility for stress-related cognitive impairments.",2020,"After stress, MDD patients were more likely to show lower performance in working memory as well as in selective and sustained attention compared with participants without MDD.","['patients with major depressive disorder', 'MDD patients with (N = 32) and without (N = 52', 'healthy participants', 'and healthy participants with (N = 22) and without (N = 37']","['control condition (Placebo-TSST', 'ACE']","['psychomotoric speed and working memory', 'verbal memory', 'cognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",,0.0218758,"After stress, MDD patients were more likely to show lower performance in working memory as well as in selective and sustained attention compared with participants without MDD.","[{'ForeName': 'Linn K', 'Initials': 'LK', 'LastName': 'Kuehl', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schultebraucks', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Christian E', 'Initials': 'CE', 'LastName': 'Deuter', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'Asklepios Fachklinikum Tiefenbrunn, Rosdorf, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Spitzer', 'Affiliation': 'Asklepios Fachklinikum Tiefenbrunn, Rosdorf, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Psychiatry and Psychotherapy, Berlin, Germany.'}]",Development and psychopathology,['10.1017/S0954579419000932']
3694,32088296,"Effects of Colesevelam on Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression in Patients With Bile Acid Diarrhea in a Randomized Trial.","BACKGROUND & AIMS


Approximately one-third of patients with IBS-diarrhea (IBS-D) have increased bile acid (BA) synthesis or excretion. An open-label study showed benefits of colesevelam on bowel functions, consistent with luminal BA sequestration by colesevelam. We compared the effects of colesevelam vs placebo on symptoms and gene expression patterns in the sigmoid colon mucosa in patients with BA diarrhea associated with IBS-D.
METHODS


We performed a double-blind, parallel-group study of 30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center. Patients were randomly assigned (1:1) to groups given colesevelam (3 tablets, 625 mg each) or matching placebo, orally twice daily for 4 weeks. Stool diaries documented bowel functions for 8 days before and 28 days during colesevelam or placebo. Stool and fasting serum samples were collected for analyses of fecal BAs and serum levels of C4 and FGF19. We measured colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels in rectosigmoid biopsies. All measurements were made at baseline and on the last days of treatment. The primary endpoints were change in total fecal BA concentration and stool consistency.
RESULTS


Compared with placebo, colesevelam was associated with significant changes in sequestered fecal total BA excretion (P < .001) and serum levels of C4 and FGF19 (both P < .001), and with a mean increase in fecal level of deoxycholic acid (10%; P = .07) compared to placebo. Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline. Stool frequency and consistency, colonic transit, and permeability did not differ significantly between groups. Colesevelam was well tolerated.
CONCLUSIONS


In a randomized trial, we found that colesevelam increases delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors. Larger studies are needed to determine the effects on clinical responses. ClinicalTrials.gov no: NCT03270085.",2020,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","['Patients with Bile Acid Diarrhea', '30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center', 'patients with BA diarrhea associated with IBS-D']","['Colesevelam', 'colesevelam vs placebo', 'placebo', 'colesevelam (3 tablets, 625 mg each) or matching placebo']","['delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors', 'colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels', 'Stool frequency and consistency, colonic transit, and permeability', 'tolerated', 'bile acid (BA) synthesis or excretion', 'total fecal BA concentration and stool consistency', 'sequestered fecal total BA excretion (P<.001) and serum levels of C4 and FGF19', 'Stool and fasting serum samples', 'Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression', 'colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1', 'fecal level of deoxycholic acid', 'fecal BAs and serum levels of C4 and FGF19']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4524087', 'cui_str': 'Bile acid diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0011479', 'cui_str': 'Deoxycholic Acid'}]",30.0,0.381983,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vijayvargiya', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota. Electronic address: camilleri.michael@mayo.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carlson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sara Linker', 'Initials': 'SL', 'LastName': 'Nord', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryks', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Rhoten', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Busciglio', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lueke', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Donato', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.027']
3695,29992584,Association of IFNλ4 rs12979860 polymorphism with the acquisition of HCV and HIV infections among people who inject drugs.,"We investigated the presence of a single-nucleotide polymorphism designated rs12979860 in the interferon λ4 (IFNλ4) gene among 345 people who inject drugs (PWID) and 495 blood donors to evaluate associations between the rs12979860 genotypes and human immunodeficiency virus/hepatitis C virus (HIV/HCV). The rs12979860 TT genotype was over-represented among HIV+ PWID than HIV- PWID and blood donors (16% vs 8% and 10%, P = 0.03, respectively). PWID with TT genotype had approximately twice the probability of being HIV+ (odds ratio [OR], 2.19; 95% confidence interval [CI], 1.11 to 4.33) than PWID without TT. Every additional year of intravenous drug use (IVDU) decreased the OR 1.16 times (OR, 0.86; 95% CI, 0.75 to 0.98). This suggests that rs12979860 TT increases susceptibility to HIV and this impact decreases with increasing duration of IVDU.",2018,"PWID with TT genotype had approximately twice the probability of being HIV+ (odds ratio [OR], 2.19; 95% confidence interval [CI], 1.11 to 4.33) than PWID without TT.","['people who inject drugs', '345 people who inject drugs (PWID) and 495 blood donors to evaluate associations between the rs12979860 genotypes and human immunodeficiency virus/hepatitis C\xa0virus (HIV/HCV']",[],"['duration of IVDU', 'probability of being HIV']","[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220847', 'cui_str': 'Hepatitis C virus'}]",[],"[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242566', 'cui_str': 'Intravenous drug user (finding)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",345.0,0.0993268,"PWID with TT genotype had approximately twice the probability of being HIV+ (odds ratio [OR], 2.19; 95% confidence interval [CI], 1.11 to 4.33) than PWID without TT.","[{'ForeName': 'Ene-Ly', 'Initials': 'EL', 'LastName': 'Jõgeda', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Radko', 'Initials': 'R', 'LastName': 'Avi', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Pauskar', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Eveli', 'Initials': 'E', 'LastName': 'Kallas', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Tõnis', 'Initials': 'T', 'LastName': 'Karki', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Des Jarlais', 'Affiliation': 'Department of Environmental Medicine and Public Health, New York, NY, USA.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Uusküla', 'Affiliation': 'Institute of Family Medicine and Public Health, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Karolin', 'Initials': 'K', 'LastName': 'Toompere', 'Affiliation': 'Institute of Family Medicine and Public Health, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Irja', 'Initials': 'I', 'LastName': 'Lutsar', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Huik', 'Affiliation': 'Department of Microbiology, Institute of Biomedicine and Translational Medicine, Faculty of Medicine, University of Tartu, Tartu, Estonia.'}]",Journal of medical virology,['10.1002/jmv.25258']
3696,31322024,Effect of physical therapy on early knee osteoarthritis with medial meniscal posterior tear assessed by MRI T2 mapping and 3D-to-2D registration technique: A prospective intervention study.,"Objectives:  The purpose of this study was to verify that exercise aimed at improving knee kinematics in early-stage knee osteoarthritis (OA) patients with medial meniscus posterior root tears (MMPRTs) reduces knee adduction angle during gait and prevents rapid cartilage degeneration in the medial compartment of the knee. Methods:  Subjects were randomly assigned to an adapting alignment exercise (AAE) group, with the goal of improving knee kinematics, and a muscle training and exercise (MTE) group. Before the start of the six-month intervention and following its completion, we performed an analysis of knee kinematics during gait using a 3D-to-2D registration technique and identified the area of cartilage degeneration using MRI T2 mapping. Results:  The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: -0.14, 1.09) in the MTE group and -0.40° (-0.84, 0.04) in the AAE group ( p  = .039). The amount of change in the area of cartilage degeneration according to MRI T2 mapping expressed as MTE/AAE group was 7.7 mm 2  (-0.4, 15.8)/-2.7 mm 2  (-10.8, 5.3) at the posterior knee ( p  = .043). Conclusion:  AAE could be a potential treatment method that improves the natural course of knee OA with MMRPTs.",2020,"The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: -0.14, 1.09) in the MTE group and -0.40° (-0.84, 0.04) in the AAE group ( p  = .039).","['early knee osteoarthritis with medial meniscal posterior tear assessed by', 'early-stage knee osteoarthritis (OA) patients with medial meniscus posterior root tears (MMPRTs']","['MRI T2 mapping and 3D-to-2D registration technique', 'physical therapy', 'adapting alignment exercise (AAE) group, with the goal of improving knee kinematics, and a muscle training and exercise (MTE']",['knee kinematics'],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348073', 'cui_str': 'Medial Menisci'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}]",,0.0731694,"The amount of change between pre- and post-intervention measurements of the maximum angle of adduction was 0.48° (95% CI: -0.14, 1.09) in the MTE group and -0.40° (-0.84, 0.04) in the AAE group ( p  = .039).","[{'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Ikuta', 'Affiliation': 'Department of Orthopedic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, International University of Health and Welfare Hospital, Tochigi, Japan.'}, {'ForeName': 'Sanshiro', 'Initials': 'S', 'LastName': 'Hashimoto', 'Affiliation': 'Minami-Shinjuku Orthopaedic Rehabilitation Clinic, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Orthopedic Surgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Yuzawa', 'Affiliation': 'Inanami Spine and Joint Hospital, Tokyo, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Inanami', 'Affiliation': 'Inanami Spine and Joint Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinro', 'Initials': 'S', 'LastName': 'Takai', 'Affiliation': 'Department of Orthopedic Surgery, Nippon Medical School, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2019.1646193']
3697,31128267,Editorial: Antidepressants to the Rescue in Severe Mood Dysregulation and Disruptive Mood Dysregulation Disorder?,"Children with irritability and outbursts pose a serous therapeutic problem. Many of them have attention-deficit/hyperactivity disorder (ADHD) with emotion dysregulation, which is sometimes captured in the diagnosis of disruptive mood dysregulation disorder (DMDD). Some follow-up data find a connection between DMDD and depression and anxiety in adults. This prompted Towbin and colleagues 1  to launch a trial where children (ages 7-17) with DMDD were treated first with methylphenidate (MPH) and then randomized to citalopram (CTP) or placebo over 8 weeks. The response to CTP was complicated by lack of specific measures of both irritable mood and severity of outbursts. Future studies should include standardized and normed parent and teacher measures of both externalizing and internalizing behavior as well as irritability specific measures rating how the child feels. Studies also need better measures of the actual outbursts-not just their frequency but how agitated or aggressive the child gets during an outburst (ie, what the child does) and how long the outbursts last. Measuring DMDD on inpatient units is especially complicated because of the therapeutic nature of the setting. Further work is needed with much larger samples to identify who improves with the treatment, exactly which domains of psychopathology improve and by how much. Finally, It is also critical to conduct longer-term trials to determine the stability of the response beyond 8 weeks.",2020,The response to CTP was complicated by lack of specific measures of both irritable mood and severity of outbursts.,"['adults', 'children (ages 7-17) with DMDD were treated first with', 'Children with irritability and outbursts pose a serous therapeutic problem']","['citalopram (CTP) or placebo', 'methylphenidate (MPH']",['DMDD and depression and anxiety'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",17.0,0.0234667,The response to CTP was complicated by lack of specific measures of both irritable mood and severity of outbursts.,"[{'ForeName': 'Gabrielle A', 'Initials': 'GA', 'LastName': 'Carlson', 'Affiliation': 'Renaissance School of Medicine at Stony Brook University, NY. Electronic address: Gabrielle.Carlson@Stonybrook.edu.'}, {'ForeName': 'Daniel N', 'Initials': 'DN', 'LastName': 'Klein', 'Affiliation': 'State University of New York at Stony Brook, NY.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.05.016']
3698,31563977,Comparing local anesthetic infiltration of the peritonsillar region and glossotonsillar sulcus for post-tonsillectomy pain management.,"PURPOSE


The objective of this study was to compare the efficacy of peritonsillar and glossotonsillar sulcus infiltration with bupivacaine to manage postoperative pain and odynophagia in children undergoing tonsillectomy.
METHODS


Fifty children (5-10 years of age) undergoing tonsillectomy due to recurrent tonsillar infections were enrolled in the study and assigned into two groups receiving either pre-incisional peritonsillar (Group 1, n = 25) or glossotonsillar sulcus (Group 2, n = 25) infiltration with 1 mg/kg bupivacaine (0.5%) totaling 5 mL in volume. At different time intervals following arrival to the post-anesthesia care unit (PACU), the participants in each group were evaluated for pain using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) and for odynophagia using a four-point scale (1-none, normal or no difficulty with swallowing, 2-mild, mild difficulty with swallowing, 3-moderate, moderate difficulty with swallowing, and 4-severe, no swallowing or swallowing only with maximal effort). Additional parameters were assessed for 24 h post-surgery, including time to first administration of analgesic, additional analgesic requirements, nausea/vomiting, allergic reaction, and bleeding.
RESULTS


Infiltration of either region with bupivacaine yielded similar analgesic effects at different times following the surgery (P = 0.065). Time to first analgesic treatment and additional analgesic requirements were not significantly different between groups (P = 0.181). Compared to the Group 1, Group 2 was associated with significantly lower odynophagia scores at different times after the surgery (P = 0.020).
CONCLUSION


Present results indicate that the infiltration of local anesthetics to glossotonsillar sulcus is a safe, practical, and effective pain management intervention without risk of significant side effects for children undergoing tonsillectomy.",2020,Time to first analgesic treatment and additional analgesic requirements were not significantly different between groups (P = 0.181).,"['and for odynophagia using a four-point scale (1-none, normal or no difficulty with swallowing, 2-mild, mild difficulty with swallowing, 3-moderate, moderate difficulty with swallowing, and 4-severe, no swallowing or swallowing only with maximal effort', 'Fifty children (5-10\xa0years of age) undergoing tonsillectomy due to recurrent tonsillar infections', 'children undergoing tonsillectomy']","['bupivacaine', 'pre-incisional peritonsillar (Group 1, n\u2009=\u200925) or glossotonsillar sulcus (Group 2, n\u2009=\u200925) infiltration with 1\xa0mg/kg bupivacaine']","['time to first administration of analgesic, additional analgesic requirements, nausea/vomiting, allergic reaction, and bleeding', ""pain using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS"", 'odynophagia scores', 'analgesic effects', 'Time to first analgesic treatment and additional analgesic requirements']","[{'cui': 'C0221150', 'cui_str': 'Swallowing painful (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0456306', 'cui_str': 'Glossotonsillar sulcus (body structure)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",50.0,0.036276,Time to first analgesic treatment and additional analgesic requirements were not significantly different between groups (P = 0.181).,"[{'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Yücel Ekici', 'Affiliation': 'Department of Otorhinolaryngology, Adana City Training and Research Hospital, 01060, Adana, Turkey. nuryekici@hotmail.com.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Özdoğan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Adana City Training and Research Hospital, Adana, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05668-2']
3699,31867651,The Impact of Gradual and Immediate Nicotine Reduction on Subjective Cigarette Ratings.,"BACKGROUND


A recent clinical trial showed that an immediate transition to very low nicotine content (VLNC) cigarettes, compared with a gradual transition, produced greater reductions in smoking behavior, smoke exposure, and dependence. However, there was less compliance with the instruction to smoke only VLNC cigarettes in the immediate versus gradual reduction condition. The goal of this study was to test whether nicotine reduction method alters subjective ratings of VLNC cigarettes, and whether subjective ratings mediate effects of nicotine reduction method on smoking behavior, smoke exposure, dependence, and compliance.
METHODS


This is a secondary analysis of a randomized trial conducted across 10 sites in the United States. Smokers (n = 1250) were randomized to either a control condition, or to have the nicotine content of their cigarettes reduced immediately or gradually to 0.04 mg nicotine/g of tobacco during a 20-week study period. Participants completed the modified Cigarette Evaluation Questionnaire (mCEQ).
RESULTS


After Week 20, the immediate reduction group scored significantly lower than the gradual reduction group on multiple subscales of the mCEQ (ps < .001). The Satisfaction subscale of the mCEQ mediated the impact of nicotine reduction method on smoke exposure, smoking behavior, dependence, compliance, and abstinence. Other subscales also mediated a subset of these outcomes.
CONCLUSIONS


An immediate reduction in nicotine content resulted in lower product satisfaction than a gradual reduction, suggesting that immediate reduction further reduces cigarette reward value. This study will provide the Food and Drug Administration with information about the impact of nicotine reduction method on cigarette reward value.
IMPLICATIONS


These data suggest that an immediate reduction in nicotine content will result in greater reductions in cigarette satisfaction than a gradual reduction, and this reduction in satisfaction is related to changes in smoking behavior and dependence.",2019,"After Week 20, the immediate reduction group scored significantly lower than the gradual reduction group on multiple subscales of the mCEQ (ps < .001).","['Smokers (n = 1250', '10 sites in the United States']","['nicotine reduction method', 'nicotine', 'nicotine content of their cigarettes reduced immediately or gradually to 0.04 mg nicotine/g of tobacco']","['Subjective Cigarette Ratings', 'modified Cigarette Evaluation Questionnaire (mCEQ', 'smoke exposure, smoking behavior, dependence, compliance, and abstinence', 'Satisfaction subscale', 'cigarette satisfaction', 'smoking behavior, smoke exposure, dependence, and compliance', 'smoking behavior, smoke exposure, and dependence']","[{'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",1250.0,0.0165502,"After Week 20, the immediate reduction group scored significantly lower than the gradual reduction group on multiple subscales of the mCEQ (ps < .001).","[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Hollings Cancer Center, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Baptist Comprehensive Cancer Center, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Carroll', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Dermody', 'Affiliation': 'School of Psychological Science, Oregon State University, Corvallis, OR.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz158']
3700,31738680,Comparison of a Silicon Skin Pad and a Tea Towel as Models for Learning a Simple Interrupted Suture.,"There has been rapid growth in the range of models available for teaching veterinary clinical skills. To promote further uptake, particularly in lower-income settings and for students to practice at home, factors to consider include cost, availability of materials and ease of construction of the model. Two models were developed to teach suturing: a silicon skin pad, and a tea towel (with a check pattern) folded and stapled to represent an incision. The models were reviewed by seven veterinarians, all of whom considered both suitable for teaching, with silicon rated as more realistic. The learning outcome of each model was compared after students trained to perform a simple interrupted suture. Thirty-two second-year veterinary students with no prior suturing experience were randomly assigned to three training groups: silicon skin pad or tea towel (both self-directed with an instruction booklet), or watching a video. Following training, all students undertook an Objective Structured Clinical Examination (OSCE), placing a simple interrupted suture in piglet cadaver skin. The OSCE pass rates of the three groups were silicon skin pad, 10/11; tea towel, 9/10; and video, 1/11. There was no significant difference between the model groups, but the model groups were significantly different from the video group ( p  < .017). In conclusion, the tea towel was as effective as the silicon skin pad, but it was cheaper, simpler to make, and the materials were more readily available. In addition, both models were used effectively with an instruction booklet illustrating the value of self-directed learning to complement taught classes.",2020,"There was no significant difference between the model groups, but the model groups were significantly different from the video group ( p  < .017).","['Thirty-two second-year veterinary students with no prior suturing experience', 'in piglet cadaver skin']","['silicon skin pad or tea towel (both self-directed with an instruction booklet), or watching a video', 'Silicon Skin Pad and a Tea Towel', 'Objective Structured Clinical Examination (OSCE), placing a simple interrupted suture', 'silicon skin pad, and a tea towel (with a check pattern) folded and stapled to represent an incision']",['OSCE pass rates'],"[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C1123023', 'cui_str': 'Skin'}]","[{'cui': 'C0037107', 'cui_str': 'Silicon'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0336616', 'cui_str': 'Towel, device (physical object)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]",[],32.0,0.0155269,"There was no significant difference between the model groups, but the model groups were significantly different from the video group ( p  < .017).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baillie', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Christopher', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Catterall', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kruydenberg', 'Affiliation': 'equine veterinarian working in practice in the United Kingdom and overseas.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lawrenson', 'Affiliation': 'Bristol Veterinary School.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Wonham', 'Affiliation': 'United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kilfeather', 'Affiliation': 'Department of Physiology.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Warman', 'Affiliation': 'Bristol Veterinary School.'}]",Journal of veterinary medical education,['10.3138/jvme.2018-0001']
3701,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND


Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS


This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS


Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION


In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3702,31645472,Therapeutic-induced hypertension in patients with noncardioembolic acute stroke.,"OBJECTIVE


To evaluate the safety and efficacy of induced hypertension in patients with acute ischemic stroke.
METHODS


In this multicenter randomized clinical trial, patients with acute noncardioembolic ischemic stroke within 24 hours of onset who were ineligible for revascularization therapy and those with progressive stroke during hospitalization were randomly assigned (1:1) to the control and intervention groups. In the intervention group, phenylephrine was administered intravenously to increase systolic blood pressure (SBP) up to 200 mm Hg. The primary efficacy endpoint was early neurologic improvement (reduction in NIH Stroke Scale [NIHSS] score of ≥2 points during the first 7 days). The secondary efficacy endpoint was a modified Rankin Scale score of 0 to 2 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage/edema, myocardial infarction, and death.
RESULTS


In the modified intention-to-treat analyses, 76 and 77 patients were included in the intervention and control groups, respectively. After adjustment for age and initial stroke severity, induced hypertension increased the occurrence of the primary (odds ratio 2.49, 95% confidence interval [CI] 1.25-4.96,  p  = 0.010) and secondary (odds ratio 2.97, 95% CI 1.32-6.68,  p  = 0.009) efficacy endpoints. Sixty-seven (88.2%) patients of the intervention group exhibited improvements in NIHSS scores of ≥2 points during induced hypertension (mean SBP 179·7 ± 19.1 mm Hg). Safety outcomes did not significantly differ between groups.
CONCLUSION


Among patients with noncardioembolic stroke who were ineligible for revascularization therapy and those with progressive stroke, phenylephrine-induced hypertension was safe and resulted in early neurologic improvement and long-term functional independence.
CLINICALTRIALSGOV IDENTIFIER


NCT01600235.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with acute ischemic stroke, therapeutic-induced hypertension increases the probability of early neurologic improvement.",2019,Sixty-seven (88.2%) patients of the intervention group exhibited improvements in NIHSS scores of ≥2 points during induced hypertension (mean SBP 179·7 ± 19.1 mm Hg).,"['patients with noncardioembolic acute stroke', 'patients with acute ischemic stroke', 'patients with noncardioembolic stroke who were ineligible for revascularization therapy and', 'patients with acute noncardioembolic ischemic stroke within 24 hours of onset who were ineligible for revascularization therapy and those with progressive stroke during hospitalization']","['Therapeutic-induced hypertension', 'phenylephrine']","['Safety outcomes', 'systolic blood pressure (SBP', 'modified Rankin Scale score', 'early neurologic improvement and long-term functional independence', 'symptomatic intracranial hemorrhage/edema, myocardial infarction, and death', 'early neurologic improvement (reduction in NIH Stroke Scale [NIHSS] score of ≥2 points', 'safety and efficacy', 'NIHSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}]",,0.165857,Sixty-seven (88.2%) patients of the intervention group exhibited improvements in NIHSS scores of ≥2 points during induced hypertension (mean SBP 179·7 ± 19.1 mm Hg).,"[{'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Bang', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea. ohyoung.bang@samsung.com.'}, {'ForeName': 'Jong-Won', 'Initials': 'JW', 'LastName': 'Chung', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Soo-Kyoung', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Suk Jae', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Mi Ji', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Jaechun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Yeon Soo', 'Initials': 'YS', 'LastName': 'Ha', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Sung', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea. ohyoung.bang@samsung.com.'}, {'ForeName': 'Eung-Gyu', 'Initials': 'EG', 'LastName': 'Kim', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Moon-Ku', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'From the Department of Neurology (O.Y.B., J.-W.C., M.J.L., W.-K.S.), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; Department of Neurology and Institute of Health Science (S.-K.K.), Gyeongsang National University College of Medicine, Jinju; Department of Neurology (S.J.K.), Hana General Hospital, Cheongju; Department of Neurology (J.H.), Kyungpook National University Chilgok Hospital, Daegu; Department of Neurology (Y.S.H.), Wonkwang University, School of Medicine, Iksan; Department of Neurology (S.M.S.), Pusan National University Hospital; Department of Neurology (E.-G.K.), Busan Paik Hospital, Inje University; Department of Neurology (S.-I.S.), Keimyung University School of Medicine, Daegu; and Department of Neurology (M.-K.H.), Seoul National University Bundang Hospital, Seongnam, Korea.'}]",Neurology,['10.1212/WNL.0000000000008520']
3703,31721601,Cost and utility in immunocompromised subjects who developed herpes zoster during the randomized V212 inactivated varicella-zoster vaccine (ZV IN ) trial.,"Objectives : Immunocompromised subjects are at increased risk for herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN). We describe health utilities, health care resource utilization (HCRU), productivity loss and health care costs in recipients of autologous hematopoietic stem-cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial.  Methods : HCRU, costs, and EQ-5D-3L utility were assessed for 155 confirmed HZ cases observed after receiving inactivated varicella-zoster virus (VZV) vaccine (ZV IN ) or placebo. In a prospective, longitudinal 6-month follow up, costs and utilities were analyzed for two health states, HZ without PHN and HZ with PHN.  Results : There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729). The disutility for HZ without PHN was estimated to -0.117 and to -0.186 for HZ with PHN. Direct costs (2017 USD) associated with a HZ without PHN episode and HZ with PHN episode was estimated at $3,412 and $3,711, respectively, of which hospitalizations accounted for 90% of the costs.  Expert opinion:  Both HZ and PHN are associated with considerable disutility in recipients of Auto-HSCT. Costs were comparable to published estimates in other immunocompromised subjects. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT01229267).",2020,There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729).,"['Immunocompromised subjects', 'recipients of autologous hematopoietic stem cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial', 'immunocompromised subjects who developed herpes zoster during the randomized V212 Inactivated Varicella-Zoster Vaccine (ZV IN ) trial']","['HZ without PHN and HZ with PHN', 'inactivated varicella zoster virus (VZV) vaccine (ZV IN ) or placebo']","['costs, and EQ-5D-3L utility', 'Direct costs', 'HZ without PHN episode and HZ with PHN episode', 'Cost and utility', 'health utilities, health care resource utilization (HCRU), productivity loss and health care costs', 'disutility for HZ without PHN']","[{'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C1319755', 'cui_str': 'Varicella-zoster vaccine'}]","[{'cui': 'C0042338', 'cui_str': 'Human herpesvirus 3'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.104853,There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729).,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Eriksson', 'Affiliation': 'Real-World Evidence Strategy & Analytics, ICON plc , Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hunger', 'Affiliation': 'Real-World Evidence Strategy & Analytics, ICON plc , Munich, Germany.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bourhis', 'Affiliation': 'Global HTA, Health Economics, Reimbursement and Outcomes, ICON plc , Paris, France.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Thorén', 'Affiliation': 'Real-World Evidence Strategy & Analytics, ICON plc , Stockholm, Sweden.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Popmihajlov', 'Affiliation': 'Clinical Research, Merck & Co., Inc , Kenilworth, NJ, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Finelli', 'Affiliation': 'Center for Observational and Real-world Evidence,L Merck & Co., Inc Kenilworth, NJ, UK.'}, {'ForeName': 'Yiling', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center for Observational and Real-world Evidence, Merck Sharp & Dohme Ltd , Hoddesdon, UK.'}]",Expert review of pharmacoeconomics & outcomes research,['10.1080/14737167.2020.1693267']
3704,29588232,The effect of beta-adrenergic blockade on inflammatory and cardiovascular responses to acute mental stress.,"Acute mental stress elicits increases in plasma cytokine concentrations in humans, but the underlying mechanisms remain poorly understood. We assessed the impact of beta-adrenergic blockade on plasma interleukin 6 (IL-6) and IL-1 receptor antagonist (IL-1Ra) responses in a parallel group, double-blind randomised placebo-controlled trial involving 64 healthy young adult volunteers. Participants were administered 80 mg slow-release propranolol or placebo daily for 7 days before the stress testing session in which responses to 3 behavioural challenges (public speaking, mirror tracing, mental arithmetic) were evaluated. Propranolol administration was associated with reduced baseline levels of heart rate and IL-1Ra, and systolic blood pressure (BP) in men. Tasks stimulated increased plasma IL-6 concentrations sampled 45 min and 75 min after challenge, but these responses were blocked by propranolol in men (p < 0.001). Propranolol did not influence IL-6 responses in women, or IL-1Ra in either sex. Blood pressure and heart rate increased markedly during the tasks, but there was no differential stress reactivity in propranolol and placebo conditions. The results of the study support a role of sympathetic nervous system activation in stimulating acute IL-6 responses to stress, but only in men. The reasons for the differences between men and women remain to be resolved.",2018,"Blood pressure and heart rate increased markedly during the tasks, but there was no differential stress reactivity in propranolol and placebo conditions.","['64 healthy young adult volunteers', 'acute mental stress']","['placebo', 'Propranolol', 'beta-adrenergic blockade', 'propranolol', 'propranolol or placebo']","['IL-6 responses', 'plasma IL-6 concentrations', 'plasma interleukin 6 (IL-6) and IL-1 receptor antagonist (IL-1Ra) responses', 'heart rate and IL-1Ra, and systolic blood pressure (BP', 'Blood pressure and heart rate', 'plasma cytokine concentrations']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",64.0,0.389057,"Blood pressure and heart rate increased markedly during the tasks, but there was no differential stress reactivity in propranolol and placebo conditions.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Steptoe', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London WC1E 6BT, UK. Electronic address: A.steptoe@ucl.ac.uk.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Ronaldson', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kostich', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Antonio I', 'Initials': 'AI', 'LastName': 'Lazzarino', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Urbanova', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Livia A', 'Initials': 'LA', 'LastName': 'Carvalho', 'Affiliation': 'Department of Epidemiology and Public Health, University College London, London WC1E 6BT, UK.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2018.03.027']
3705,31020442,Return-to-Player Percentage in Gaming Machines: Impact of Informative Materials on Player Understanding.,"The addictive potential of electronic gaming machines (EGMs) is currently explained within a cognitive-behavioural framework. This framework explains that various erroneous cognitions regarding players' likelihood of winning contribute to persistent EGM gambling behaviour. Related to these cognitions is the pervasive misunderstanding among players regarding the operation of EGMs. However, little research has focussed specifically on player understanding of the theoretical proportion returned to players over the lifetime of a machine; return to player percentage. This study aimed to investigate the extent to which players understand the concept return to player percentage presented in different educative formats. A sample of 112 university students were randomly allocated to one of four conditions pertaining to a different mode of information delivery; infographic, vignette, brochure, or mandated legislation (control). Participants completed post-intervention measures to determine changes in knowledge. As predicted, participants exhibited a lack of understanding of the concept of return to player at baseline. However, contrary to predictions, exposure to any of the experimental conditions did not result in a greater understanding of return to player than controls. The study findings emphasise the difficulty individuals have in understanding complex concepts related to return to player percentages when presented in current formats and content. Treatment and responsible gambling policies need to adopt strategies to effectively improve knowledge of this aspect of the structural characteristics of gaming machines.",2020,"However, contrary to predictions, exposure to any of the experimental conditions did not result in a greater understanding of return to player than controls.",['112 university students'],"['electronic gaming machines (EGMs', 'information delivery; infographic, vignette, brochure, or mandated legislation (control']",[],"[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0600657', 'cui_str': 'Legislation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0227243,"However, contrary to predictions, exposure to any of the experimental conditions did not result in a greater understanding of return to player than controls.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Beresford', 'Affiliation': 'Faculty of Science, Brain and Mind Centre, School of Psychology, The University of Sydney, 94 Mallett Street, Camperdown, Sydney, NSW, 2050, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Blaszczynski', 'Affiliation': 'Faculty of Science, Brain and Mind Centre, School of Psychology, The University of Sydney, 94 Mallett Street, Camperdown, Sydney, NSW, 2050, Australia. alex.blaszczynski@sydney.edu.au.'}]",Journal of gambling studies,['10.1007/s10899-019-09854-z']
3706,31748594,A Four Month Randomized Controlled Trial on the Efficacy of Once-daily Fenofibrate Monotherapy in Persons with Spinal Cord Injury.,"An open-label, randomized clinical trial of once-daily fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG) was performed in persons with chronic spinal cord injury (SCI). Fenofibrate (145 mg tablet) was self-administered daily in 10 persons with SCI for 4 months with monthly blood testing to quantify the lipoprotein profile (e.g., serum TG, LDL-C, and HDL-C concentrations). Eight SCI participants were control subjects. In comparison to the control group, the treatment group at Mo2 had a 40% (±12%; p < 0.05) reduction in serum TG concentration, a 28% (±21%; p < 0.05) increase in HDL-C and 14% (±20%; p < 0.05) decline in LDL-C. In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.",2019,"In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.","['persons with chronic spinal cord injury (SCI', 'Persons with Spinal Cord Injury', 'Eight SCI participants were control subjects']","['Fenofibrate', 'Once-daily Fenofibrate Monotherapy', 'fenofibrate monotherapy administered for 2- (Mo2) and 4- (Mo4) months using modified intervention thresholds for triglyceride (TG']","['HDL-C', 'serum TG concentration', 'LDL-C', 'serum lipoprotein profile and ratios']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0196628,"In the same comparison at Mo4, the treatment group maintained a 40% (±20%; p < 0.05) reduction in serum TG concentration, had an 18% in reduction in LDL-C (±12%; p < 0.05) and a 23% (±23%; p < 0.05) increase in HDL-C. Fenofibrate monotherapy for Mo2 and Mo4 initiated in persons with SCI resulted in a robust and favorable change in the serum lipoprotein profile and ratios, suggesting reduced risk for cardiovascular disease.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'La Fountaine', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA. michael.lafountaine@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hobson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lombard', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Adam F', 'Initials': 'AF', 'LastName': 'Specht', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'Department of Veterans Affairs Rehabilitation Research & Development Service National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}]",Scientific reports,['10.1038/s41598-019-53753-7']
3707,31690831,Randomised Phase 2 study of lapatinib and vinorelbine vs vinorelbine in patients with HER2 + metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16).,"BACKGROUND


The continuum of anti-HER2 agents is a standard treatment of HER2 + metastatic breast cancer (MBC). This study evaluated the efficacy of lapatinib plus vinorelbine in patients progressed on both trastuzumab and lapatinib treatments.
METHODS


A total of 149 patients were randomly assigned to lapatinib with vinorelbine (LV) (n = 75; lapatinib, 1000 mg daily; vinorelbine 20 mg/m 2  D1, D8 q3w) or vinorelbine (V) (n = 74; 30 mg/m 2  D1, D8 q3w). The primary endpoint was progression-free survival (PFS) rate at 18 weeks.
RESULTS


The median number of previous anti-HER2 therapies was 2 (range 2-5). There was no significant difference in PFS rate at 18 weeks between LV and V arms (45.9% vs 38.9%, p = 0.40). ORR was 19.7% in LV arm, and 16.9% in V arm (p = 0.88). PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58). Toxicity profiles were similar in both arms and all were manageable.
CONCLUSIONS


Lapatinib plus vinorelbine treatment was tolerable; however, it failed to demonstrate the clinical benefits over vinorelbine alone in patients with HER2 + MBC after progression on both trastuzumab and lapatinib.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number NCT01730677.",2019,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","['patients progressed on both trastuzumab and lapatinib treatments', 'A total of 149 patients', 'patients with HER2\u2009+\u2009metastatic breast cancer after lapatinib and trastuzumab treatment (KCSG BR11-16']","['Lapatinib plus vinorelbine', 'lapatinib with vinorelbine (LV) (n\u2009=\u200975; lapatinib, 1000\u2009mg daily; vinorelbine 20\u2009mg/m 2  D1, D8 q3w) or vinorelbine (V', 'lapatinib and vinorelbine vs vinorelbine', 'vinorelbine', 'lapatinib plus vinorelbine']","['ORR', 'median number of previous anti-HER2 therapies', 'Toxicity profiles', 'progression-free survival (PFS) rate', 'PFS and OS', 'PFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",149.0,0.125427,"PFS and OS did not differ between two arms (LV vs V; median PFS, 16 vs 12 weeks, HR = 0.86, 95% CI 0.61-1.22; median OS, 15.0 vs 18.9 months, HR = 1.07, 95% CI 0.72-1.58).","[{'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Sim', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. parkih@ncc.re.kr.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei University, College of Medicine, Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Yu Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Medical Oncology, Department of Internal medicine, Seoul National University Bundang Hospital, Bundang, Korea.'}, {'ForeName': 'Suee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Internal medicine, Dong-A University, College of Medicine, Busan, Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University, College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yee Soo', 'Initials': 'YS', 'LastName': 'Chae', 'Affiliation': 'Kyungpook National University, College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Division of Oncology/Hematology, Korea University, Seoul, Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute & Hospital, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Keun Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea.'}, {'ForeName': 'Jungsil', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'Center for Breast Cancer, Research Institute, National Cancer Center, Goyang, Korea. jungsro@ncc.re.kr.'}]",British journal of cancer,['10.1038/s41416-019-0618-z']
3708,31801388,Anti-inflammatory Medication of Cataract Surgery in Pseudoexfoliation Syndrome - NSAID Is Needed.,"BACKGROUND


To optimize the anti-inflammatory treatment of cataract surgery in pseudoexfoliation syndrome (PXF) eyes.
METHODS


A prospective randomized double-masked trial. Sixty eyes of 60 patients with PXF undergoing routine cataract surgery were randomized for potent topical postoperative anti-inflammatory medication either with prednisolone acetate (10mg/ml), nepafenac (1mg/ml) or their combination. Clinical outcome parameters were recorded at 28 days and 3 months. Recovery from surgery was recorded by a structured home questionnaire.
RESULTS


Patient age and gender distribution, and all baseline ophthalmic and surgical parameters were comparable between the study groups. At 28 days, change in central subfield macular thickness was +11.4 ± 11.9 µm in prednisolone acetate group compared to +1.7 ± 16.8 µm in nepafenac ( P  = .017), and -0.3 ± 8.7 µm in combination therapy ( P  = .010) groups. At 3 months, the values were +11.8 ± 18.1 µm, +1.8 ± 17.5 µm ( P  = .055), and -1.3 ± 6.4 µm ( P  = .055), respectively. Pseudophakic cystoid macular edema (PCME) was reported in two eyes, both with prednisolone acetate monotherapy. After surgery, conjunctival injection lasted 6.5 ± 5.0 days and irritation of the eye 9.5 ± 8.5 days in prednisolone acetate group compared with nepafenac (2.6 ± 2.2 days;  P  = .037 and 4.3 ± 5.2 days;  P  = NS, respectively) and combination therapy (3.3 ± 1.9 days;  P  = NS and 3.0 ± 4.0 days;  P  = .025, respectively).
CONCLUSIONS


Routine cataract surgery of PXF eyes with nonsteroidal anti-inflammatory drugs (NSAID) alone, or in combination with steroids resulted in faster recovery from surgery and avoidance of PCME compared to steroids alone.
ABBREVIATIONS


BAB: blood-aqueous barrier; CDVA: corrected distance visual acuity; CDE: cumulative dissipated energy; CSMT: central subfield macular thickness; HRQoL: Health-related quality of life; IOP: intraocular pressure; logMAR: log of the minimum angle of resolution; NSAID: nonsteroidal anti-inflammatory drug; PCME: pseudophakic cystoid macular edema; PXF: pseudoexfoliation syndrome; OCT: optical coherence tomography; t.i.d.: three times a day; VA: visual acuity.",2020,"At 28 days, change in central subfield macular thickness was +11.4±11.9µm in prednisolone acetate group compared to +1.7±16.8µm in nepafenac ( P =0.017), and -0.3±8.7µm in combination therapy ( P =0.010) groups.","['pseudoexfoliation syndrome - NSAID', 'pseudoexfoliation syndrome (PXF) eyes', 'Sixty eyes of 60 patients with PXF undergoing routine cataract surgery']","['nepafenac', 'prednisolone acetate monotherapy', 'cataract surgery', 'nonsteroidal anti-inflammatory drugs (NSAID) alone, or in combination with steroids', 'prednisolone acetate', 'topical postoperative anti-inflammatory medication either with prednisolone acetate (10mg/ml), nepafenac (1mg/ml) or their combination']","['Pseudophakic cystoid macular edema (PCME', 'central subfield macular thickness']","[{'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0645984', 'cui_str': 'PCME'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",60.0,0.145893,"At 28 days, change in central subfield macular thickness was +11.4±11.9µm in prednisolone acetate group compared to +1.7±16.8µm in nepafenac ( P =0.017), and -0.3±8.7µm in combination therapy ( P =0.010) groups.","[{'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Ilveskoski', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki , Helsinki, Finland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Taipale', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki , Helsinki, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Tuuminen', 'Affiliation': 'Helsinki Retina Research Group, University of Helsinki , Helsinki, Finland.'}]",Current eye research,['10.1080/02713683.2019.1701686']
3709,31749307,Coaching to improve self-directed learning.,"BACKGROUND


The continuously changing health care context necesitates that medical trainees develop self-directed learning skills. This study examined the effect of coaching on the self-directed learning process in pre-clerkship medical students.
METHODS


We conducted a longitudinal educational intervention using standardised patient assessments to determine the effect of self-assessment, feedback, and coaching on the development and implementation of learning goals (LGs). Students were sorted into control and intervention groups. Following each assessment, students received feedback on performance and created LGs. Students in the intervention group worked with a faculty member coach on their LGs. Students in the control group developed their LGs without a coach. Prior to the final assessment, students reported whether they had implemented their LGs.
RESULTS


Of 171 students enrolled, 167 completed all four assessments and were included. All 167 developed an LG after each assessment. Overall, 79.0% of students reported implementing an LG. Of students receiving coaching, 91.8% implemented an LG, whereas only 65.9% of students in the control group implemented an LG (odds ratio, OR 5.7; 95% confidence interval, CI 2.4-14.2). Students who received coaching were more likely to incorporate performance feedback into their LGs (90.2 versus 38.1%; p < 0.05).
CONCLUSIONS


For students, faculty member coaching facilitated better LG development and more frequent implementation compared with students who did not receive coaching.",2020,"For students, faculty member coaching facilitated better LG development and more frequent implementation compared with students who did not receive coaching.","['pre-clerkship medical students', '171 students enrolled, 167 completed all four assessments and were included']",['faculty member coach on their LGs'],[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]",[],167.0,0.0159089,"For students, faculty member coaching facilitated better LG development and more frequent implementation compared with students who did not receive coaching.","[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stojan', 'Affiliation': 'Internal Medicine, University of Michigan Medical Center, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Buckler', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Cranford', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Whitman', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Gruppen', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Santen', 'Affiliation': 'Emergency Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}]",The clinical teacher,['10.1111/tct.13109']
3710,31829654,A tier 1 intervention to increase ninth grade engagement and success: Results from a randomized controlled trial.,"Although high school graduation rates are improving, many students are still not successful. Research has documented that 9th grade is a pivotal year in determining whether a student will graduate or drop out. The purpose of this randomized controlled trial was to assess the effects of a Tier 1 intervention model (freshmen success) for 9th grade students to increase school engagement, attendance, credits earned, and grade point average (GPA). This study included 1,588 students in ninth grade across 4 comprehensive high schools. Treatment schools implemented the freshmen success components: a 9th grade leadership team, a curriculum, and support from peer navigators. Control schools continued business as usual. Results showed statistically significant and educationally meaningful effects on student motivation, engagement and attendance, and a moderate-to-large effect for credits earned. However, there was no significant effect found for GPA. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"However, there was no significant effect found for GPA.","['1,588 students in ninth grade across 4 comprehensive high schools']",[],"['ninth grade engagement and success', 'student motivation, engagement and attendance, and a moderate-to-large effect', 'school engagement, attendance, credits earned, and grade point average (GPA']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205443', 'cui_str': 'Ninth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0205443', 'cui_str': 'Ninth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",2020.0,0.0741268,"However, there was no significant effect found for GPA.","[{'ForeName': 'K Brigid', 'Initials': 'KB', 'LastName': 'Flannery', 'Affiliation': 'Department of Educational and Community Supports, University of Oregon.'}, {'ForeName': 'Mimi McGrath', 'Initials': 'MM', 'LastName': 'Kato', 'Affiliation': 'Department of Educational and Community Supports, University of Oregon.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Kittelman', 'Affiliation': 'Department of Educational and Community Supports, University of Oregon.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'McIntosh', 'Affiliation': 'Department of Educational and Community Supports, University of Oregon.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Triplett', 'Affiliation': 'Department of Educational and Community Supports, University of Oregon.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000347']
3711,31907080,Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomised controlled study.,"BACKGROUND


The prevalence of central obesity is constantly increasing, and visceral fat is associated with increased production of inflammatory factors and metabolic risk factors. Lutein might retard the development of metabolic disease through its antioxidant and anti-inflammatory properties. Furthermore, epidemiological studies have associated higher dietary intake and serum levels of lutein with decreased adiposity. However, few randomised controlled trials have shown the effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors, especially in adults with central obesity.
METHODS


This study will be conducted as a double-blind, parallel placebo-controlled clinical trial in which 120 people who have central obesity, are 18 to 60 years old and are willing to provide informed consent will be randomly assigned to the intervention or placebo group in a 1:1 ratio according to sex, age and waist circumference. The intervention group will receive 10 mg daily lutein supplementation for 12 weeks to explore the effect of lutein supplementation on serum lutein, glycaemic and lipid profiles, inflammatory factors and body composition. Two populations (intention-to-treat population and per-protocol population) will be used in the data analyses.
DISCUSSION


Our findings from this trial will contribute to the knowledge of the association between lutein supplementation and inflammatory biomarkers and metabolic risk factors in people with central obesity and will offer a possibility for the prevention of inflammatory diseases.
TRIAL REGISTRATION


Chinese Clinical Trial Registry: ChiCTR1800018098. Registered on 30 August 2018.",2020,"Our findings from this trial will contribute to the knowledge of the association between lutein supplementation and inflammatory biomarkers and metabolic risk factors in people with central obesity and will offer a possibility for the prevention of inflammatory diseases.
","['adults with central obesity', 'people with central obesity', '120 people who have central obesity, are 18 to 60\u2009years old and are willing to provide informed consent']","['placebo', 'lutein supplementation', 'Lutein', '10\u2009mg daily lutein supplementation']","['serum lutein, glycaemic and lipid profiles, inflammatory factors and body composition', 'inflammatory biomarkers and metabolic risk factors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551560', 'cui_str': 'Central obesity (disorder)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",120.0,0.319096,"Our findings from this trial will contribute to the knowledge of the association between lutein supplementation and inflammatory biomarkers and metabolic risk factors in people with central obesity and will offer a possibility for the prevention of inflammatory diseases.
","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Shenzhen Nanshan Centre for Chronic Disease Control, Shenzhen, 518054, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Shenzhen Nanshan Centre for Chronic Disease Control, Shenzhen, 518054, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Shenzhen Nanshan Centre for Chronic Disease Control, Shenzhen, 518054, China.'}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Shenzhen Nanshan Centre for Chronic Disease Control, Shenzhen, 518054, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Shenzhen Nanshan Centre for Chronic Disease Control, Shenzhen, 518054, China. xiaolinpeng@hotmail.com.'}]",Trials,['10.1186/s13063-019-3998-8']
3712,31907056,Effects of sang-qi granules on blood pressure and endothelial dysfunction in stage I or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial.,"BACKGROUND


Worldwide, hypertension is an important public health challenge because of its high prevalence and the concomitant risks of cardiovascular disease. It induces half of the coronary heart disease and approximately two-thirds of the cerebrovascular disease burden. Vascular endothelial dysfunction has important roles in the pathophysiology of essential hypertension. Types I and II hypertension can be treated with sang-qi granules (SQG), a Chinese herbal formula. Several experimental studies on animals have shown that SQG can lower blood pressure and myocardial fibrosis by suppressing inflammatory responses. However, no standard clinical trial has confirmed this. Whether SQG can improve endothelial cell function is unknown.
METHODS/DESIGN


In this randomized double-blind double-simulation controlled trial, 300 patients with stage I or II hypertension will be recruited and randomly allocated in a 1:1:1 ratio to group A (treatment with SQG and placebo instead of Losartan), group B (treatment with Losartan and placebo instead of SQG), and group C (treatment with SQG and Losartan). In this study, 10 g of SQG (or its placebo) will be administrated twice a day and 50 mg of Losartan (or its placebo) will be administrated once in the morning. The primary endpoint is the drug efficiency for each of the three groups. The secondary endpoints are the change in average systolic and diastolic blood pressure during the day and the night, the change in the rate at which blood pressure drops at night, assessment of target organ damage (heart rate variability, ankle-brachial pressure index, and pulse wave velocity), assessment of any improvement in symptoms (Hypertension Symptom Scale, syndrome integral scale in traditional Chinese medicine, Pittsburgh Sleep Quality Index Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and the 36-Item Short Form Health Survey), blood lipids, serum indicators of vascular function (changes in serum levels of ET-1, TXA2, NO, and PGI2), and safety indicators.
DISCUSSION


This study aims to provide clinical evidence on the efficacy and safety of SQG in the treatment of hypertension. Moreover, the possible mechanism by which SQG may lower blood pressure will be explored by observing the protective effect of SQG on vascular endothelial function, as well as its effect on related clinical symptoms, risk factors, and the target organs of hypertension.
TRIAL REGISTRATION


Chinese Clinical Trials Registry, ChiCTR1800016427. Registered on 1 June 2018.",2020,"The secondary endpoints are the change in average systolic and diastolic blood pressure during the day and the night, the change in the rate at which blood pressure drops at night, assessment of target organ damage (heart rate variability, ankle-brachial pressure index, and pulse wave velocity), assessment of any improvement in symptoms (Hypertension Symptom Scale, syndrome integral scale in traditional Chinese medicine, Pittsburgh Sleep Quality Index Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and the 36-Item Short Form Health Survey), blood lipids, serum indicators of vascular function (changes in serum levels of ET-1, TXA2, NO, and PGI2), and safety indicators.
","['300 patients with stage I or II hypertension', 'stage I or II hypertension']","['sang-qi granules', 'sang-qi granules (SQG', 'Losartan (or its placebo', 'SQG', 'Losartan and placebo instead of SQG), and group C (treatment with SQG and Losartan', 'SQG and placebo instead of Losartan', 'SQG (or its placebo']","['average systolic and diastolic blood pressure during the day and the night, the change in the rate at which blood pressure drops at night, assessment of target organ damage (heart rate variability, ankle-brachial pressure index, and pulse wave velocity), assessment of any improvement in symptoms (Hypertension Symptom Scale, syndrome integral scale in traditional Chinese medicine, Pittsburgh Sleep Quality Index Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and the 36-Item Short Form Health Survey), blood lipids, serum indicators of vascular function (changes in serum levels of ET-1, TXA2, NO, and PGI2), and safety indicators', 'drug efficiency', 'endothelial cell function', 'blood pressure and endothelial dysfunction', 'blood pressure and myocardial fibrosis']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1276055', 'cui_str': 'ABPI - Ankle brachial pressure index'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0222045'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0040057', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,11-epoxy-15-hydroxy-, (5Z,9alpha,11alpha,13E,15S)-'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0151654', 'cui_str': 'Myocardial fibrosis'}]",300.0,0.394888,"The secondary endpoints are the change in average systolic and diastolic blood pressure during the day and the night, the change in the rate at which blood pressure drops at night, assessment of target organ damage (heart rate variability, ankle-brachial pressure index, and pulse wave velocity), assessment of any improvement in symptoms (Hypertension Symptom Scale, syndrome integral scale in traditional Chinese medicine, Pittsburgh Sleep Quality Index Scale, Self-Rating Anxiety Scale, Self-Rating Depression Scale, and the 36-Item Short Form Health Survey), blood lipids, serum indicators of vascular function (changes in serum levels of ET-1, TXA2, NO, and PGI2), and safety indicators.
","[{'ForeName': 'Haoyue', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Dong Cheng District, Beijing, 100010, China.'}, {'ForeName': 'Deshuang', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Ruihan', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Ruiqing', 'Initials': 'R', 'LastName': 'Jing', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Integrative Cardiology,, China-Japan Friendship Hospital,, Chao Yang District, Beijing, 100029, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Integrative Cardiology,, China-Japan Friendship Hospital,, Chao Yang District, Beijing, 100029, China. lihstrong@163.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Integrative Cardiology,, China-Japan Friendship Hospital,, Chao Yang District, Beijing, 100029, China. lilinxcy@126.com.'}]",Trials,['10.1186/s13063-019-3690-z']
3713,30693674,Voice in Digital Education: The Impact of Instructor's Perceived Age and Gender on Student Learning and Evaluation.,"Instructor evaluations are influenced by implicit age and gender bias, with lower ratings and negative feedback given to instructors believed to stray from stereotypical age and gender norms. Female instructors exhibiting typically male-associated qualities such as leadership and authority, are often negatively impacted. Implicit bias also influences evaluation of digital resources and instructors, regardless of students' positive learning outcomes. As digital learning resources become the norm in education, it is crucial to explore the impact of implicit bias at various educational levels. In this study, undergraduate and graduate students were randomly exposed to one of five digital tutorials; four experimental tutorials presenting identical anatomy content with narrators of different gender and age, and a control tutorial featuring origami (paper folding) instructions without audio. Learning outcomes were measured by pre-quiz vs. post-quiz comparisons using repeated measures MANOVA. Implicit bias was analyzed by evaluation response comparisons using repeated measures MANOVA and three-way MANOVA. Post-quiz scores increased significantly in the four experimental groups (P < 0.05) but not in the control (P = 0.99). The increased performance was not statistically different across the four experimental groups (P > 0.26), suggesting that learning occurred irrespective of the instructor gender and age. Students' evaluations were consistently higher for the experimental resources than the control. There was no significant difference in evaluations across the four experimental groups but compared to the control, younger male and younger female narrators received significantly higher ratings for approachability, acceptance, inclusivity, and care for student learning. The study highlights important considerations for digital resources development and interpretation of student evaluations.",2020,"There was no significant difference in evaluations across the four experimental groups but compared to the control, younger male and younger female narrators received significantly higher ratings for approachability, acceptance, inclusivity, and care for student learning.","['Voice in Digital Education', 'undergraduate and graduate students']","['five digital tutorials; four experimental tutorials presenting identical anatomy content with narrators of different gender and age, and a control tutorial featuring origami (paper folding) instructions without audio']","['Learning outcomes', 'Implicit bias', 'increased performance', 'Post-quiz scores', 'ratings for approachability, acceptance, inclusivity, and care for student learning']","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",,0.0311508,"There was no significant difference in evaluations across the four experimental groups but compared to the control, younger male and younger female narrators received significantly higher ratings for approachability, acceptance, inclusivity, and care for student learning.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Weinkle', 'Affiliation': 'Touch of Life Technologies, Aurora, Colorado.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Stratford', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Lisa M J', 'Initials': 'LMJ', 'LastName': 'Lee', 'Affiliation': 'Master of Science in Modern Human Anatomy Program, University of Colorado, Graduate School, Aurora, Colorado.'}]",Anatomical sciences education,['10.1002/ase.1865']
3714,31937344,Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial.,"BACKGROUND


The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA).
METHODS AND DESIGN


FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses.
DISCUSSION


To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT00549172 (Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear). Registered on 25 October 2007 (NCT00549172). ClinicalTrials.gov, NCT01052233 (Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear). Registered on 20 January 2010.",2020,"As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out.
","['adults (age 35 to 65\u2009years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA', '146 patients', 'Degenerative Medial Meniscus Tear', 'patients with an arthroscopically verified degenerative tear of the medial meniscus', 'After Arthroscopic Partial Resection of Degenerative Meniscus Tear']","['APM (resection of torn meniscus tear', 'APM', 'placebo-surgery', 'arthroscopic partial meniscectomy (APM']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238218', 'cui_str': 'Tear of meniscus of knee (disorder)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348073', 'cui_str': 'Medial Menisci'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1275678', 'cui_str': 'Tear lake'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}]",[],146.0,0.147391,"As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out.
","[{'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Sihvonen', 'Affiliation': 'Department of Orthopedics and Traumatology, Tampere University Hospital, Hatanpää, Tampere, Finland.'}, {'ForeName': 'Roope', 'Initials': 'R', 'LastName': 'Kalske', 'Affiliation': 'Finnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Englund', 'Affiliation': 'Clinical Epidemiology Unit, Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Clinical Epidemiology Unit, Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Finnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland.'}, {'ForeName': 'Teppo L N', 'Initials': 'TLN', 'LastName': 'Järvinen', 'Affiliation': 'Finnish Center for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki and Helsinki University Hospital, Töölö hospital, Topeliuksenkatu 5, Building B, 00260, Helsinki, Finland. teppo.jarvinen@helsinki.fi.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3833-2']
3715,31863206,The effect of preemptive use of pregabalin on postoperative morphine consumption and analgesia levels after laparoscopic colorectal surgery: a controlled randomized trial.,"PURPOSE


In order to reduce postoperative opioid administration and pain levels in patients submitted to laparoscopic colectomy, we assessed the efficacy of preemptive use of pregabalin (PG), as part of a multimodal analgesia scheme, in a randomized controlled trial setting.
METHODS


Overall, fifty adult patients scheduled for elective laparoscopic colectomy were included and randomized in our trial. In the experimental group, 23 patients received preoperatively 2 doses of 150 mg PG per os, whereas the control group consisted of 27 cases, where a matching to PG placebo was administered at the same scheme. The two groups had identical analgesia and anesthesia regimens otherwise. Our study endpoints included postoperative morphine consumption, postoperative pain, and complication rates.
RESULTS


Patients in the PG group displayed a significantly reduced morphine consumption at 8 h, 24 h, and 48 h postoperatively. The two groups were comparable in terms of postoperative pain (rest and movement assessment) and side effects.
CONCLUSIONS


The preoperative addition of PG resulted in a significant reduction of the postoperative opioid consumption in patients undergoing laparoscopic colectomy. However, an association with the postoperative pain scores was not identified.",2020,"RESULTS


Patients in the PG group displayed a significantly reduced morphine consumption at 8 h, 24 h, and 48 h postoperatively.","['fifty adult patients scheduled for elective laparoscopic colectomy', 'patients submitted to laparoscopic colectomy', 'laparoscopic colorectal surgery', 'patients undergoing laparoscopic colectomy']","['pregabalin', 'matching to PG placebo', 'pregabalin (PG']","['postoperative opioid consumption', 'postoperative pain scores', 'postoperative pain (rest and movement assessment) and side effects', 'postoperative morphine consumption, postoperative pain, and complication rates', 'postoperative morphine consumption and analgesia levels', 'postoperative opioid administration and pain levels', 'morphine consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",50.0,0.314887,"RESULTS


Patients in the PG group displayed a significantly reduced morphine consumption at 8 h, 24 h, and 48 h postoperatively.","[{'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Baloyiannis', 'Affiliation': 'Department of Surgery, University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Theodorou', 'Affiliation': 'Department of Anesthesiology, Hippokrateio Hospital of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Chamaidi', 'Initials': 'C', 'LastName': 'Sarakatsianou', 'Affiliation': 'Department of Anesthesiology, University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Georgopoulou', 'Affiliation': 'Department of Anesthesiology, University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Perivoliotis', 'Affiliation': 'Department of Surgery, University Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tzovaras', 'Affiliation': 'Department of Surgery, University Hospital of Larissa, Larissa, Greece. gtzovaras@hotmail.com.'}]",International journal of colorectal disease,['10.1007/s00384-019-03471-3']
3716,31907018,"Health Pregnancy, Healthy Baby: testing the added benefits of pregnancy ultrasound scan for child development in a randomised control trial.","BACKGROUND


The 2016 World Health Organization Antenatal Guidelines and the 2015 South African Maternal and Child Health Guidelines recommend one early antenatal ultrasound scan to establish gestational age and to detect multiple pregnancies and fetal abnormalities. Prior research indicates that ultrasound scan can also increase parental-fetal attachment. We aim to establish whether, compared to routine care, messages to promote parental attachment and healthy child development, conducted during one or two pregnancy ultrasound scans, improve early child development and growth, exclusive breastfeeding, parental-child interactions and prenatal and postnatal clinic attendance.
METHODS


The effect of messages to sensitise mothers and fathers to fetal development will be tested in a three-armed randomised trial with 100 mothers and their partners from Soweto, Johannesburg in each arm. The primary outcome is child development at 6 months postnatally. Secondary outcomes include infant feeding, parental attachment and interaction, parental mental health and infant growth, assessed at 6 weeks and 6 months. Parents in Arm 1 receive a fetal ultrasound scan < 25 weeks during routine antenatal care at tertiary hospitals, and a second standard ultrasound scan at the research site within 2 weeks. Arm 2 participants receive the routine antenatal ultrasound scan and an additional ultrasound scan < 25 weeks at the research site, together with messages to promote parental attachment and healthy child development. Arm 3 participants receive the routine ultrasound scan and two additional ultrasound scans at the research site, < 25 weeks and < 36 weeks, together with messages to promote parental attachment and healthy child development.
DISCUSSION


Evidence from high-income countries suggests that first-time prospective mothers and fathers enjoy seeing their fetus during ultrasound scan and that it is an emotional experience. A number of studies have found that ultrasound scan increases maternal attachment during pregnancy, a predictor of positive parent-infant interactions which, in turn, promotes healthy infant development. It is generally agreed that studies are needed which follow up parental-child behaviour and healthy child development postnatally, include fathers and examine the construct in a wider diversity of settings, especially in low and middle-income countries. Testing the added benefits of pregnancy ultrasound scan for child development is a gap that the proposed trial in South Africa seeks to address.
TRIAL REGISTRATION


Pan African Clinical Trials Registry, PACTR201808107241133. Registered on 15 August 2018.",2020,"The effect of messages to sensitise mothers and fathers to fetal development will be tested in a three-armed randomised trial with 100 mothers and their partners from Soweto, Johannesburg in each arm.","['100 mothers and their partners from Soweto, Johannesburg in each arm']","['ultrasound scan', 'pregnancy ultrasound scan', 'routine ultrasound scan and two additional ultrasound scans at the research site, <\u200925\u2009weeks and\u2009<\u200936\u2009weeks, together with messages to promote parental attachment and healthy child development', 'fetal ultrasound scan <\u200925\u2009weeks during routine antenatal care at tertiary hospitals, and a second standard ultrasound scan', 'routine antenatal ultrasound scan and an additional ultrasound scan <\u200925\u2009weeks at the research site, together with messages to promote parental attachment and healthy child development']","['infant feeding, parental attachment and interaction, parental mental health and infant growth, assessed at 6\u2009weeks and 6\u2009months', 'child development at 6\u2009months postnatally', 'parental-fetal attachment']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1276362', 'cui_str': 'Routine antenatal care'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}]",100.0,0.108234,"The effect of messages to sensitise mothers and fathers to fetal development will be tested in a three-armed randomised trial with 100 mothers and their partners from Soweto, Johannesburg in each arm.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Richter', 'Affiliation': 'DST-NRF Centre of Excellence in Human Development, University of the Witwatersrand, Johannesburg, South Africa. linda.richter@wits.ac.za.'}, {'ForeName': 'Wiedaad', 'Initials': 'W', 'LastName': 'Slemming', 'Affiliation': 'Department of Paediatrics, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Norris', 'Affiliation': 'SAMRC Developmental Pathways to Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women & Children's Health, King's College London, London, UK.""}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Department of Women & Children's Health, King's College London, London, UK.""}]",Trials,['10.1186/s13063-019-3924-0']
3717,31907007,"Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study).","BACKGROUND


Infliximab (INX) and other tumour necrosis factor inhibitors (TNFi) have revolutionised the treatment of several immune mediated inflammatory diseases. Still, many patients do not respond sufficiently to therapy or lose efficacy over time. The large interindividual variation in serum drug concentrations on standard doses and the development of anti-drug antibodies are thought to be major reasons for treatment failures. Therapeutic drug monitoring (TDM), an individualised treatment strategy based on systematic assessments of serum drug concentrations, has been proposed as a clinical tool to optimise efficacy of INX treatment. TDM seems reasonable both from a clinical and an economical point of view, but the effectiveness of this treatment strategy has not yet been demonstrated in randomised clinical trials. The NORwegian DRUg Monitoring study (NOR-DRUM) aims to assess the effectiveness of TDM, both with regard to the achievement of remission in patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B).
METHODS


The NOR-DRUM study is a randomised, open, controlled, parallel-group, comparative, multi-centre, national, superiority, phase IV study with two separate parts, NOR-DRUM A and NOR-DRUM B. Patients with rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, ulcerative colitis, Crohn's disease and psoriasis are included. In both study parts participants are randomised 1:1 to either TDM of infliximab (intervention group) or to standard treatment with infliximab without knowledge of drug levels or ADAb status (control group). NOR-DRUM A will include 400 patients starting INX therapy. The primary outcome is remission at 30 weeks. In NOR-DRUM B, 450 patients on maintenance treatment with INX will be included. The primary endpoint is occurrence of disease worsening during the 52-week study period.
DISCUSSION


As the first trial to assess the effectiveness, safety and cost-effectiveness of TDM in patients receiving TNFi for a range of immune mediated inflammatory diseases, we hope that the NOR-DRUM study will contribute to the advancement of evidence based personalised treatment with biological medicines.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03074656. Registered on 090317.",2020,"The NORwegian DRUg Monitoring study (NOR-DRUM) aims to assess the effectiveness of TDM, both with regard to the achievement of remission in patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B).
","['patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B', 'patients receiving TNFi for a range of immune mediated inflammatory diseases', '400 patients starting INX therapy']","['TDM of infliximab (intervention group) or to standard treatment with infliximab without knowledge of drug levels or ADAb status (control group', 'TDM', 'Therapeutic drug monitoring (TDM', 'infliximab', 'Infliximab (INX) and other tumour necrosis factor inhibitors (TNFi']","['occurrence of disease worsening', 'effectiveness, safety and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",400.0,0.0618318,"The NORwegian DRUg Monitoring study (NOR-DRUM) aims to assess the effectiveness of TDM, both with regard to the achievement of remission in patients starting INX treatment (part A) as well as to maintain disease control in patients on INX treatment (part B).
","[{'ForeName': 'Silje W', 'Initials': 'SW', 'LastName': 'Syversen', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway. s.w.syversen@gmail.com.'}, {'ForeName': 'Guro L', 'Initials': 'GL', 'LastName': 'Goll', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.'}, {'ForeName': 'Kristin K', 'Initials': 'KK', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.'}, {'ForeName': 'Inge C', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Research Support Services, Clinical Trial Unit, Oslo University Hospital, Postboks 4953 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Sandanger', 'Affiliation': 'Section of Dermatology, Oslo University Hospital, Rikshospitalet, Postboks 4953 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Johanna E', 'Initials': 'JE', 'LastName': 'Gehin', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Box 4953 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Warren', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Box 4953 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sexton', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.'}, {'ForeName': 'Cato', 'Initials': 'C', 'LastName': 'Mørk', 'Affiliation': 'Akershus Dermatology Center, Skårersletta 18, 1473, Lørenskog, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jahnsen', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.'}, {'ForeName': 'Tore K', 'Initials': 'TK', 'LastName': 'Kvien', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Bolstad', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Box 4953 Nydalen, 0424, Oslo, Norway.'}, {'ForeName': 'Espen A', 'Initials': 'EA', 'LastName': 'Haavardsholm', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Box 23 Vinderen, 0319, Oslo, Norway.'}]",Trials,['10.1186/s13063-019-3734-4']
3718,31931184,Clinical application of flap or flapless buccal surgery on the extractions of mesially/horizontally impacted 3rd molar with high or medium position impact: A comparative study.,"PURPOSE


To investigate and compare the clinical application of flap or flapless buccal surgery on the extractions of mesially/horizontally impacted 3rd molar with high or medium position impact in terms of the average surgery duration, number of root fracture, postoperative pain degree and duration, postoperative swelling degree and duration, degree of limitation of mouth opening.
MATERIALS AND METHODS


The present study was conducted of 28 patients who were examined and underwent bilateral extraction of impacted mandibular 3rd molar. One molar was randomly extracted with flap buccal surgery (Control Group, CG) and the other one with flapless buccal surgery (Experimental Group, EG) in the same patient.
RESULTS


Gender distribution, average age, average surgery duration and number of root fracture between the two groups were not statistically significant (P>0.05). The postoperative pain degree, swelling degree and degree of limitation of mouth opening were all significantly greater in CG than EG. Moreover, the duration of postoperative pain and swelling were all were all significantly longer in CG than EG (0.01<P<0.05).
CONCLUSION


Compared with the flap buccal surgery on the extractions of mesially/horizontally impacted 3rd molar with high or medium position impact, the clinical use of the flapless buccal surgery is a safe and effective method with less swelling, pain and degree of limitation of mouth opening. However, we need further study based on the broader indications, a much larger number of patients included and a follow-up in the longer term to confirm our point.",2020,"RESULTS


Gender distribution, average age, average surgery duration and number of root fracture between the two groups were not statistically significant (P>0.05).",['28 patients who were examined and underwent bilateral extraction of impacted mandibular 3rd molar'],"['Flap or Flapless Buccal Surgery', 'flap buccal surgery (Control Group, CG) and the other one with flapless buccal surgery (Experimental Group, EG', 'flap or flapless buccal surgery', 'flap buccal surgery']","['duration of postoperative pain and swelling', 'postoperative pain degree, swelling degree and degree of limitation of mouth opening', 'average surgery duration, number of root fracture, postoperative pain degree and duration, postoperative swelling degree and duration, degree of limitation of mouth opening', 'swelling, pain and degree of limitation of mouth opening', 'average surgery duration and number of root fracture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0225695,"RESULTS


Gender distribution, average age, average surgery duration and number of root fracture between the two groups were not statistically significant (P>0.05).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': 'Oral Health Centre, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rong', 'Affiliation': 'Department of Periodontics-implantology, Stomatological Hospital, Southern Medical University, Guangzhou, China. Electronic address: 23554800@qq.com.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University, Guangzhou, China. Electronic address: 187234415@smu.edu.cn.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.01.002']
3719,31405823,[Evaluation of a motivational intervention of physical activity program in the treatment of obesity and overweight].,"OBJECTIVE


To analyse the outcomes of a motivational physical activity program for the treatment of obesity.
METHOD


A randomised, controlled, double blind clinical trial with 2 arms, 12 months of follow-up and a 1:1 allocation ratio. The data was collected between July 2017 and July 2018. The patients, of both genders, had to be referred by their occupational medicine doctors with the diagnosis of overweight or obesity and be aged between 20 and 65 years. An analysis was made of the anthropometric measurements, lipid parameters, as well as on the follow-up of the program.
RESULTS


A total of 123 obese or overweight patients participated. Two groups were formed; 61 in intervention group [G1] and 62 in as usual care control group [G2]). As regards the 107 that finished the study (60 in G1 and 47 in G2), the mean age was 45.55±12.83 SD, with 57.2% women and 42.8% men. The number of patients followed-up was much higher in the Physical Activity Program than in the control group, and the number of dropouts (only one) was insignificant. It can be seen how both the weight and the body mass index as the main lipid parameters are reduced in the study group significantly with respect to the control group. The physical activity of the group in the motivated physical activity program is three times higher than in the group without intervention. There was a significant relationship between the increase in activity and weight reduction (P<.001), also between the reduction in weight and the reduction in cholesterol and triglycerides.
CONCLUSIONS


In our study, a motivational physical activity program leads to more follow-up and therefore improves the anthropometric and lipid parameters.",2020,"There was a significant relationship between the increase in activity and weight reduction (P<.001), also between the reduction in weight and the reduction in cholesterol and triglycerides.
","['patients, of both genders, had to be referred by their occupational medicine doctors with the diagnosis of overweight or obesity and be aged between 20 and 65 years', '123 obese or overweight patients participated', 'obesity and overweight']","['motivational intervention of physical activity program', 'motivational physical activity program', 'usual care control group [G2']","['activity and weight reduction', 'weight and the reduction in cholesterol and triglycerides']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0028802', 'cui_str': 'Industrial Medicine'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",123.0,0.0173468,"There was a significant relationship between the increase in activity and weight reduction (P<.001), also between the reduction in weight and the reduction in cholesterol and triglycerides.
","[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'López Tarraga', 'Affiliation': 'Facultad de Medicina, Universidad de Castilla-La Mancha, Albacete, España; Medicina de Familia, Centro de Salud Zona 5 A, Albacete, España. Electronic address: pjtarraga@sescam.jccm.es.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Madrona-Marcos', 'Affiliation': 'EAP Zona 5 A, Medicina Familia, Albacete, España.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Panisello-Royo', 'Affiliation': 'Fundación para el Fomento de la Salud, Madrid, España.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Carbayo-Herencia', 'Affiliation': 'Universidad Miguel Hernández, Elche, Alicante, España.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rosich', 'Affiliation': 'Nutricionista, Fundación para el Fomento de la Salud, Barcelona, España.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tarraga-Marcos', 'Affiliation': 'Enfermería, Hospital Clínico Lozano Blesa, Zaragoza, España.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castell', 'Affiliation': ""Servicio de Psicología, Hospital Vall d'Hebron, Barcelona, España.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alins', 'Affiliation': 'Medicina de Familia, ABS Abrera, Abrera, Barcelona, España.'}]",Hipertension y riesgo vascular,['10.1016/j.hipert.2019.05.003']
3720,31963702,Microencapsulated Tuna Oil Results in Higher Absorption of DHA in Toddlers.,": Docosahexaenoic acid (DHA) is an essential component for brain and visual acuity development during foetal and early postnatal life. A newly released directive under the European Commission stipulates DHA as a mandatory ingredient in infant formula. This poses challenges to manufacturers in preserving the stability and bioavailability of DHA at levels akin to human breast milk. The aims of this study were (a) to investigate the bioavailability of microencapsulated omega-3 DHA formulations in healthy toddlers compared with high DHA fish oil for a one-month period and (b) to assess the effect of DHA supplementation on children's sleep and cry patterns. Sixty toddlers were randomly allocated to four groups: 1. unfortified formula, 2. unfortified formula plus high DHA tuna oil, 3. fortified formula with dairy-based microencapsulated high DHA tuna oil powder, and 4. fortified formula with allergenic-free microencapsulated high DHA tuna oil powder. Bioavailability was assessed from both blood and faecal fatty acid levels. The results showed an enhanced bioavailability with significantly greater concentrations of blood DHA levels in formulas with microencapsulated powders. There were no significant effects of treatment on sleep and cry patterns. Application and delivery of microencapsulated DHA tuna oil powder in toddlers' formula provided better bioavailability of the active DHA.",2020,There were no significant effects of treatment on sleep and cry patterns.,"['healthy toddlers', 'Sixty toddlers', 'Toddlers', ""children's sleep and cry patterns""]","['DHA supplementation', 'Microencapsulated Tuna Oil', ' Docosahexaenoic acid (DHA', 'microencapsulated DHA tuna oil powder', 'high DHA fish oil', 'microencapsulated omega-3 DHA formulations']","['enhanced bioavailability', 'sleep and cry patterns', 'blood and faecal fatty acid levels', 'blood DHA levels', 'Bioavailability']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0453048', 'cui_str': 'Tuna'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1281901', 'cui_str': 'Fatty acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0768668,There were no significant effects of treatment on sleep and cry patterns.,"[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Ghasemi Fard', 'Affiliation': 'Nu-Mega Ingredients Pty Ltd., Brisbane 4000, Australia.'}, {'ForeName': 'Su Peng', 'Initials': 'SP', 'LastName': 'Loh', 'Affiliation': 'Department of Nutrition & Dietetics, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, 43300 Serdang, Selangor, Malaysia.'}, {'ForeName': 'Giovanni M', 'Initials': 'GM', 'LastName': 'Turchini', 'Affiliation': 'School of Life and Environmental Sciences, Deakin University, Geelong, Victoria 3220, Australia.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'School of Behavioural and Health Science, Australian Catholic University, Sydney 2000, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Elliott', 'Affiliation': 'Nu-Mega Ingredients Pty Ltd., Brisbane 4000, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Clayton 3168, Australia.'}]",Nutrients,['10.3390/nu12010248']
3721,28413925,"Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD: Results of a Phase 3, Double-Blind, Randomized, Forced-Dose Trial.","Objective:  Evaluate the efficacy and tolerability of triple-bead mixed amphetamine salts (MAS) in ADHD.  Method:  Adults with ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥32 were randomized to 6 weeks of triple-bead MAS (25, 50, or 75 mg) or placebo. The primary endpoint was ADHD-RS-IV total score change from baseline at end of study (EOS).  Results:  Least squares mean (95% confidence interval [CI]) treatment differences for ADHD-RS-IV total score changes from baseline to EOS significantly favored triple-bead MAS (all doses combined: -10.6 [-13.2, -8.0];  p  < .0001); there were no significant differences between triple-bead MAS dosages. The most frequently reported TEAEs with triple-bead MAS (all doses combined) included insomnia, decreased appetite, and dry mouth. Mean ±  SD  pulse and systolic blood pressure increases at EOS were 3.5 ± 10.33 bpm and 0.3 ± 10.48 mmHg with triple-bead MAS (all doses combined).  Conclusion:  Triple-bead MAS significantly reduced adult ADHD symptoms; the safety profile was consistent with previous triple-bead MAS studies.",2020,"Mean ± SD pulse and systolic blood pressure increases at EOS were 3.5 ± 10.33 bpm and 0.3 ± 10.48 mmHg with triple-bead MAS (all doses combined).
","['Adults with ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥32', 'Adults With ADHD']","['placebo', 'triple-bead mixed amphetamine salts (MAS', 'Triple-Bead Mixed Amphetamine Salts (SHP465', 'Triple-bead MAS', 'triple-bead MAS']","['ADHD-RS-IV total score change from baseline at end of study (EOS', 'insomnia, decreased appetite, and dry mouth', 'efficacy and tolerability', 'adult ADHD symptoms', 'Mean ± SD pulse and systolic blood pressure', 'ADHD-RS-IV total score changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0685294,"Mean ± SD pulse and systolic blood pressure increases at EOS were 3.5 ± 10.33 bpm and 0.3 ± 10.48 mmHg with triple-bead MAS (all doses combined).
","[{'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Frick', 'Affiliation': 'Shire, Lexington, MA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Shire, Lexington, MA, USA.'}, {'ForeName': 'Lenard A', 'Initials': 'LA', 'LastName': 'Adler', 'Affiliation': 'New York University, New York, NY, USA.'}]",Journal of attention disorders,['10.1177/1087054717696771']
3722,31956904,The Use of Eye Tracking Technology in Aesthetic Surgery: Analyzing Changes in Facial Attention Following Surgery.,"BACKGROUND


The ability to quantitatively analyze how we look at a face and determine if this changes following facial surgery should be of interest to the plastic surgeon. Eye tracking technology (ETT) provides the ability to record where observers fixate when viewing a facial image, enabling quantitative data to be obtained comparing pre- and postoperative changes.
OBJECTIVES


The authors sought to investigate ETT as a novel outcome assessment tool, determining if facial rejuvenation surgery shifts attention away from the prominent signs of aging, and if so, where this attention shifts.
METHODS


Twenty-five volunteers viewed 32 randomized frontal, oblique, and lateral images of 11 patients pre- and post-facelift. An eye movement monitoring system recorded the observer's eye position, net dwell time, fixation count, fixation time, and revisits into predefined areas of interest. Data were grouped and analyzed by angle and areas of interest. Paired t tests were employed to detect significant differences in pre- and post-images.
RESULTS


On frontal images, less dwell time, fixations, and revisits were noted on the bottom third, forehead, perioral region, and neck (P < 0.05). On the lateral view, less visual attention was given to the neck, upper third, and perioral region, with more time in the cheek, nose, and middle third (P < 0.05). On oblique images, less attention was given to the neck and upper lid with more aimed at the middle third of the face (P < 0.05).
CONCLUSIONS


ETT provides quantitative data post-facial rejuvenation. Facial aesthetic surgery does alter where observers look when viewing a face, decreasing the time spent inspecting the prominent signs of aging.",2020,"On oblique images, less attention was given to the neck and upper lid with more to the middle third of the face (p<0.05).
","['Twenty-five volunteers viewed 32 randomized frontal, oblique, and lateral images of 11 patients pre- and post-facelift']","['Eye tracking technology (ETT', 'Eye Tracking Technology']","[""observer's eye position, net dwell time, fixation count, fixation time, and revisits, into pre-defined areas of interest"", 'dwell time, fixations, and revisits']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035519', 'cui_str': 'Facelift'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0429659', 'cui_str': 'Dwell time (observable entity)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",32.0,0.0413885,"On oblique images, less attention was given to the neck and upper lid with more to the middle third of the face (p<0.05).
","[{'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Frautschi', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Nadeera', 'Initials': 'N', 'LastName': 'Dawlagala', 'Affiliation': 'Department of General Surgery, Augusta University, Augusta, GA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Klingemier', 'Affiliation': 'Center for Autism, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'England', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Sinclair', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Zins', 'Affiliation': 'Department of Plastic Surgery, Cleveland Clinic, Cleveland, OH.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa008']
3723,31969376,Salbutamol administered preoperatively to children undergoing tonsillectomy resulted in a significant reduction in rates of respiratory adverse events.,,2020,,[],['Salbutamol'],['rates of respiratory adverse events'],[],"[{'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0713691,,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Tester', 'Affiliation': 'Emergency Department, Royal Hospital for Children, Glasgow, Scotland, UK andrewtester3291@gmail.com.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Devenny', 'Affiliation': 'Respiratory Medicine, Royal Hospital For Sick Children, Yorkhill, Greater Glasgow and Clyde NHS Trust, Glasgow, Scotland, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dalrymple', 'Affiliation': 'General Paediatrics, Royal Hospital for Children, Glasgow, Scotland, UK.'}]",Archives of disease in childhood. Education and practice edition,['10.1136/archdischild-2019-318590']
3724,31680621,Neurofilament light levels are associated with long-term outcomes in multiple sclerosis.,"BACKGROUND


Neurofilament light chain (NfL) is a promising marker of disease activity/treatment response in multiple sclerosis (MS), although its predictive value for long-term clinical outcomes remains unclear.
OBJECTIVE


We measured NfL from a phase 3 trial in relapsing-remitting MS and investigated its association with outcomes after 8 and 15 years.
METHODS


NfL concentrations were measured by single molecule array assay in cerebrospinal fluid (CSF) from MS patients ( n  = 235) in a 2-year randomized clinical trial (RCT) of intramuscular interferon β-1a, and in serum ( n  = 164) from the extension study.
RESULTS


Year 2 CSF and Year 3 serum NfL were associated with brain parenchymal fraction (BPF) change over 8 years ( p  < 0.0001,  r  = -0.46;  p  < 0.05.  r  = -0.36, respectively) and were predictive of reaching Expanded Disability Status Scale (EDSS) ⩾ 6.0 at Year 8 (odds ratio (OR) (upper vs lower tertile) = 3.4; 95% confidence interval (CI) = 1.2-9.9,  p  < 0.05; OR = 11.0, 95% CI = 2.0-114.6;  p  < 0.01, respectively). Serum NfL concentration (Year 4) was predictive of reaching EDSS score ⩾6.0 at 15 years (OR (upper vs lower tertile) = 4.9; 95% CI = 1.4-20.4;  p  < 0.05). NfL concentrations were complementary to 2-year BPF change in predicting long-term outcomes.
CONCLUSION


Serum and CSF NfL concentrations were associated with long-term clinical outcomes in MS patients and are promising biomarkers for disease severity stratification supporting treatment decisions.",2020,Serum NfL concentration (Year 4) was predictive of reaching EDSS score ⩾6.0 at 15 years (OR (upper vs lower tertile) = 4.9; 95% CI = 1.4-20.4;  p  < 0.05).,"['MS patients ( n \u2009=\u2009235) in a 2-year randomized clinical trial (RCT) of intramuscular interferon β-1a, and in serum ( n \u2009=\u2009164) from the extension study']",['Neurofilament light chain (NfL'],"['brain parenchymal fraction (BPF) change', 'predictive of reaching Expanded Disability Status Scale (EDSS', 'Serum NfL concentration']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.121075,Serum NfL concentration (Year 4) was predictive of reaching EDSS score ⩾6.0 at 15 years (OR (upper vs lower tertile) = 4.9; 95% CI = 1.4-20.4;  p  < 0.05).,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kuhle', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plavina', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Barro', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Disanto', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland/Neurocenter of Southern Switzerland, Ospedale Civico, Lugano, Switzerland.'}, {'ForeName': 'Dipen', 'Initials': 'D', 'LastName': 'Sangurdekar', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Singh', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'de Moor', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Engle', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Bernd C', 'Initials': 'BC', 'LastName': 'Kieseier', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Rudick', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Goyal', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519885613']
3725,31926554,Using the anterior capsule of the hip joint to protect the tensor fascia lata muscle during direct anterior total hip arthroplasty: a randomized prospective trial.,"BACKGROUND


The direct anterior approach for total hip arthroplasty (THA) has specific advantages, but injury to the tensor fasciae lata muscle (TFLM) remains a concern. This injury in part negates some of the advantages of the intermuscular approach, because injury of the muscle fibers of the TFLM can lead to less satisfactory clinical results. Thus, in this study, we propose an intraoperative method to protect the TFLM and demonstrate its feasibility.
METHODS


Fifty-six patients undergoing THA by the direct anterior approach were divided randomly into two groups. In group A, the TFLM was protected by an autogenous tissue ""pad"" created from the anterior capsule of the joint which protect the TFLM from direct contact with the retractors. In group B, the operation was carried out with no protection of the TFLM except the attempt by the surgeons to consciously avoid injury of the TFLM. We evaluated magnitude of changes in the muscle cross-sectional area (MSCA) and fatty atrophy (FA) by magnetic resonance imaging. The differences in blood hemoglobin and serum levels of myoglobin, lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) were compared at different time, postoperatively. The Harris hip score, postoperative drainage volume and visual analogue scores (VAS) were compared between the two groups.
RESULTS


LDH, CPK and myoglobin in group B were significantly higher than group A at 8, 24, and 48 h after the surgery. (p < 0.05) Compared to the group A, the decrease of hemoglobin in group B displayed significantly at 24 and 48 h after surgery. (P < 0.05) The significantly increased MSCA and FA of TFLM were demonstrated in group B. The PDV and VAS in group B were significantly higher than group A. (P < 0.05) The Harris score in group A was significantly higher than group B (P < 0.05) one month after surgery, but there was no significant difference six months later.
CONCLUSIONS


Using the anterior capsule of the hip joint as an autogenous, protective capsular tissue pad to limit the trauma to the TFLM during a direct anterior approach to THA is an effective method to protect the TFLM and improve the clinical effect.
TRIAL REGISTRATION


ChiCTR: ChiCTR1900025173. Retrospectively registered August 15, 2019.",2020,"The Harris score in group A was significantly higher than group B (P < 0.05) one month after surgery, but there was no significant difference six months later.
","['Fifty-six patients undergoing THA by the direct anterior approach', 'total hip arthroplasty (THA', 'direct anterior total hip arthroplasty']",['TFLM'],"['blood hemoglobin and serum levels of myoglobin, lactate dehydrogenase (LDH), and creatine phosphokinase (CPK', 'hemoglobin', 'Harris hip score, postoperative drainage volume and visual analogue scores (VAS', 'MSCA and FA of TFLM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}]",[],"[{'cui': 'C0005768'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",56.0,0.0155538,"The Harris score in group A was significantly higher than group B (P < 0.05) one month after surgery, but there was no significant difference six months later.
","[{'ForeName': 'Gongyin', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Nanwei', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ""Department of Orthopedics, Jingjiang People's Hospital, 28, Zhongzhou East road, Taizhou, China.""}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University, Changzhou, China. yujiwang@sohu.com.""}]",BMC musculoskeletal disorders,['10.1186/s12891-019-3035-9']
3726,31963802,Essential Amino Acid Supplement Lowers Intrahepatic Lipid despite Excess Alcohol Consumption.,"Excess alcohol consumption is a top risk factor for death and disability. Fatty liver will likely develop and the risk of liver disease increases. We have previously demonstrated that an essential amino acid supplement (EAAS) improved protein synthesis and reduced intrahepatic lipid in the elderly. The purpose of this exploratory pilot study was to initiate the evaluation of EAAS on intrahepatic lipid (IHL), body composition, and blood lipids in individuals with mild to moderate alcohol use disorder (AUD). Following consent, determination of eligibility, and medical screening, 25 participants (18 males at 38 ± 15 years/age and 7 females at 34 ± 18 years/age) were enrolled and randomly assigned to one of two dosages: a low dose (LD: 8 g of EAAS twice/day (BID)) or high dose (HD: 13 g of EAAS BID). Five of the twenty-five enrolled participants dropped out of the intervention. Both groups consumed the supplement BID for 4 weeks. Pre- and post-EAAS administration, IHL was determined using magnetic resonance imaging/spectroscopy, body composition was analyzed using dual-energy X-ray absorptiometry, and blood parameters were measured by LabCorp. T-tests were used for statistical analysis and considered significant at  p  < 0.05. While there was no significant change in IHL in the LD group, there was a significant 23% reduction in IHL in the HD group ( p  = 0.02). Fat mass, lean tissue mass, bone mineral content, and blood lipids were not altered. Post-EAAS phosphatidylethanol was elevated and remained unchanged in LD at 407 ± 141 ng/mL and HD at 429 ± 196 ng/mL, indicating chronic and excess alcohol consumption. The HD of the proprietary EAAS formulation consumed BID seemed to lower IHL in individuals with mild to moderate AUD. We suggest that further studies in a larger cohort be conducted to more completely address this important area of investigation.",2020,"While there was no significant change in IHL in the LD group, there was a significant 23% reduction in IHL in the HD group ( p  = 0.02).","['individuals with mild to moderate AUD', 'individuals with mild to moderate alcohol use disorder (AUD', '25 participants (18 males at 38 ± 15 years/age and 7 females at 34 ± 18 years/age']","['EAAS', 'essential amino acid supplement (EAAS', 'low dose (LD: 8 g of EAAS', 'Pre- and post-EAAS administration']","['Fat mass, lean tissue mass, bone mineral content, and blood lipids', 'IHL', 'intrahepatic lipid (IHL), body composition, and blood lipids']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",25.0,0.0607911,"While there was no significant change in IHL in the LD group, there was a significant 23% reduction in IHL in the HD group ( p  = 0.02).","[{'ForeName': 'Melynda S', 'Initials': 'MS', 'LastName': 'Coker', 'Affiliation': 'Department of Natural Resources and Environment, University of Alaska Fairbanks, 505 South Chandalar Drive, Fairbanks, AK 99775, USA.'}, {'ForeName': 'Kaylee R', 'Initials': 'KR', 'LastName': 'Ladd', 'Affiliation': 'Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK 99775, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK 99775, USA.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Murphy', 'Affiliation': 'Institute of Arctic Biology, Department of Chemistry & Biochemistry, University of Alaska Fairbanks1930 Yukon Dr. Room 136, Fairbanks, AK 99775, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'DeCort', 'Affiliation': 'Bassett Army Community Hospital, 4076 Neely Road, FortWainwright, United States Army, Fairbanks, AK 99703, USA.'}, {'ForeName': 'Bradley R', 'Initials': 'BR', 'LastName': 'Newcomer', 'Affiliation': 'Honors College, 1501 251Warren Service Drive, Room 105, James Madison University, Harrisonburg, VA 22807, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, 4301 West Markham, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Coker', 'Affiliation': 'Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK 99775, USA.'}]",Nutrients,['10.3390/nu12010254']
3727,31953834,"Effect of Different Musical Types on Patient's Relaxation, Anxiety and Pain Perception during Shock Wave Lithotripsy: A Randomized Controlled Study.","PURPOSE


The aim of this study was to investigate the effects of listening to different music types during extracorporeal shock wave lithotripsy (SWL) on the patients' pain control, anxiety level, and satisfaction.
MATERIALS AND METHODS


This study was a prospective single-blinded, paral-lel-group randomized clinical trial with balanced ran-domization [1:1]. A total of 150 patients who underwent first-session SWL were included in the study. The patients were randomly divided in to five groups (30 participants in each group) as follows: headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5. Demographic data related to patients and procedure, State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure (0: never 4: happily), and patient satisfaction rates (0: poor 4: excellent) were recorded immediately after the procedure.
RESULTS


There was a statistically significant difference between groups in terms of median VAS scores (7, 6, 4.5, 5, and 4, respectively, P<.001), whereas the VAS scores in Groups 3, 4, and 5 were significantly lower than those in Group 1 and 2 (P<.001). The median STAI-SA scores between the groups were significantly different (45, 45, 42, 45, and 40, respectively, P<.001), while the anxiety levels in Groups 3, 4, and 5 were significantly lower than those in Group 1 (P=.008, P=.018, and P<.001, respectively). Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
CONCLUSIONS


Music therapy during SWL reduced the patients' pain and anxiety scores, moreover listening to the patient's preferred music type provided greater satisfaction. Listening to the patient's preferred music type could be standardized and routinely used during SWL.",2020,"Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
","['150 patients who underwent first-session SWL were included in the study', 'Shock Wave Lithotripsy']","['extracorporeal shock wave lithotripsy (SWL', 'headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5', 'Different Musical Types', 'Music therapy']","['median VAS scores', ""patients' pain and anxiety scores"", 'pain control, anxiety level, and satisfaction', 'anxiety levels', 'willingness to repeat the procedure and patient satisfaction rates', 'VAS scores', ""Patient's Relaxation, Anxiety and Pain Perception"", 'State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure ', 'median STAI-SA scores', 'patient satisfaction rates']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}]","[{'cui': 'C0015359', 'cui_str': 'Extracorporeal Shockwave Lithotripsy'}, {'cui': 'C0441067', 'cui_str': 'Earphones (physical object)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.0563542,"Moreover, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P<.001).
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Çift', 'Affiliation': 'Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey. dr.alicift@gmail.com.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Benlioglu', 'Affiliation': 'Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey.'}]",Urology journal,['10.22037/uj.v0i0.5333']